JP2009543607A - Method and apparatus for the treatment of atrial fibrillation - Google Patents

Abstract

An apparatus and method for the treatment of atrial fibrillation that may monitor the ablated tissue under direct visualization for tissue parameters (eg, temperature and impedance) before, during, or after ablation. I will explain it. The system may include an indwelling catheter and an attached imaging hood that can be placed in the expanded structure. The imaging hood is placed in or adjacent to the tissue to be imaged in a body lumen that is usually filled with an opaque body fluid such as blood. Translucent or transparent fluid can be pumped into the imaging hood until the fluid displaces blood, leaving a clear area of tissue that is imaged through the imaging element in the indwelling catheter It is. An ablation probe and one or more probes with sensors are advanced into the ablated and monitored tissue. Alternatively, combined ablation and survey probes may be used.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is filed July 10, 2006, US Provisional Patent Application Nos. 60 / 806,923; 60 / 806,924; and 60 / 806,926. And claims the benefit of priority to 60 / 891,472, filed February 23, 2007; this application is also US Provisional Patent Application No. 60, filed February 2, 2005; This is a continuation-in-part of US application Ser. No. 11 / 259,498, filed on Oct. 25, 2005, claiming priority over US / 649,246. These applications are incorporated herein by reference in their entirety.

The present invention relates generally to medical devices used to access, visualize and / or treat regions of tissue within the body. More specifically, the present invention relates to a method and apparatus for accessing, visualizing and / or treating symptoms such as atrial fibrillation and monitoring ablation therapy in a patient's heart.

BACKGROUND OF THE INVENTION Conventional devices for visualizing internal regions of body lumens are known. For example, an ultrasonic device is used to generate an image from within a living body. Ultrasound is typically used both with and without contrast agents that enhance ultrasound-derived images.

  Other conventional methods have utilized catheters or probes having position sensors that are placed in body lumens, such as inside a ventricle. These types of position sensors are typically used to determine cardiac tissue surface movement, or electrical activity within the heart tissue. Once a sufficient number of points have been sampled by the sensor, a “map” of heart tissue may be generated.

  Another conventional device utilizes an inflatable balloon that is typically introduced transvascularly in an deflated state and then inflated against the tissue region to be examined. Imaging is typically accomplished by other devices such as optical chips or electronic chips for viewing tissue through the membrane of an inflated balloon. In addition, the balloon must generally be inflated to image. Other conventional balloons utilize a cavity or indentation formed at the distal end of the inflated balloon. This cavity or indentation is pressed against the tissue to be examined and washed with clarified fluid to provide an unobstructed path through the blood.

  However, such an imaging balloon has many inherent disadvantages. For example, such balloons generally require the balloon to be inflated to a relatively large size, which can undesirably replace surrounding tissue and prevent fine positioning of the imaging system relative to the tissue. Furthermore, the working area created by such inflatable balloons is generally cramped and limited in size. In addition, the inflated balloon may be susceptible to changes in pressure of the surrounding fluid. For example, if the environment surrounding the inflated balloon is subjected to a pressure change, for example during the contraction and expansion pressure cycles of the beating heart, the constant pressure change can affect the volume of the inflated balloon and its positioning Can cause unstable or undesirable conditions for normal tissue imaging.

  Thus, these types of diagnostic imaging methods generally provide desirable images useful for sufficient diagnosis and treatment of intraluminal structures, in part due to factors such as kinetic effects generated by the natural movement of the heart. I can't. Furthermore, anatomical structures within the body can occlude or interfere with the image acquisition process. Also, the presence or movement of opaque bodily fluids such as blood generally makes it difficult to image biological tissue in a tissue region within the heart.

  Other external diagnostic imaging methods are also conventionally used. For example, computed tomography (CT) and magnetic resonance imaging (MRI) are typical modalities that are widely used to acquire images of body lumens such as the internal chambers of the heart. However, such diagnostic imaging methods cannot provide real-time imaging for intraoperative therapeutic procedures. For example, fluoroscopy is widely used to identify anatomical landmarks in the heart and other areas of the body. However, fluoroscopy cannot provide an accurate image of tissue quality or surface, nor can it provide instrumentation for performing tissue manipulation or other therapeutic procedures on the visualized tissue region. . Fluoroscopy also provides a shadow of the intervening tissue on the plate or sensor when it may be desirable to look at the intraluminal surface of the tissue to diagnose the condition or to perform some form of treatment on it. .

  Therefore, it is possible to provide a real-time biological image of a tissue region in a body lumen such as the heart through an opaque medium such as blood, and a tissue imaging system that provides an instrument for a visual tissue treatment procedure Is desirable.

SUMMARY OF THE INVENTION Tissue imaging that may be used for procedures in body lumens such as the heart where visualization of the surrounding tissue is difficult, if not impossible, due to media contained in the lumen such as blood The operating device will be described below. In general, such tissue imaging and manipulation devices include an optional delivery catheter or sheath through which an indwelling catheter and imaging hood may be advanced for placement relative to or adjacent to the tissue being imaged. .

  The indwelling catheter may define a fluid delivery lumen therethrough as well as an imaging lumen in which an optical imaging fiber or assembly may be placed to image tissue. If the open area or area is defined by the imaging hood, when deployed, the imaging hood may expand into any number of shapes, for example, cylindrical, conical as shown, hemispherical, etc. Good. An open area is an area within which a tissue area of interest may be imaged. The imaging hood may also define an atraumatic contact lip or edge for placement, or an adjacency to the tissue region of interest. Further, the distal end of an indwelling catheter or a separate manipulable catheter may be articulated manually through various control mechanisms such as push-pull wires or via computer control.

  The indwelling catheter may also be stabilized against the tissue surface through various methods. For example, an inflatable stabilization balloon positioned along the length of the catheter may be used, or a tissue engaging anchor can be passed through or along the indwelling catheter for temporary engagement of the underlying tissue. May be passed through.

  In operation, after the imaging hood is in place, fluid may be pumped at positive pressure through the fluid delivery lumen until the fluid completely fills the open area and replaces blood from within the open area. The fluid may comprise any biocompatible fluid, such as saline, water, plasma, Fluorinert ™, etc., that is sufficiently transparent to allow relatively undistorted visualization through the fluid. . The fluid may be pumped continuously or intermittently to allow image capture by an optional processor that may be in communication with the assembly.

  In an exemplary variation for imaging a tissue surface within a ventricle containing blood, a tissue imaging and treatment system generally includes a catheter body having a lumen defined therethrough, and a catheter body adjacent to the catheter body. A visualization element disposed in a field, wherein the visualization element having a field of view, a transparent fluid source in fluid communication with the lumen, and a blood replacement between the visualization element and the field of view by a transparent fluid flowing from the lumen A barrier or membrane extendable from the catheter body and a penetrating device translatable through the displaced blood to penetrate into the tissue surface in the field of view.

  The imaging hood may be formed into any number of structures, and the imaging assembly may also be utilized with any number of treatment tools that may be placed through an indwelling catheter.

  In certain variations, more specifically, the tissue visualization system may comprise a component that includes an imaging hood, in which case the hood is further disposed over the main opening and the distal end of the hood. It may also include a membrane with various optional openings. The introducer sheath or indwelling catheter on which the imaging hood is placed can further be steered by a plurality of adjacent links that are pivotally connected to each other and can be articulated in a single plane or in multiple planes. Possible divisions may be provided. The indwelling catheter itself may consist of multiple lumen extrusion, such as four lumen catheter extrusion, reinforced with braided stainless steel fibers to provide structural support. The proximal end of the catheter may be coupled to a handle for system operation and articulation.

  In additional variations of the imaging hood and indwelling catheter, the various assemblies may be configured to treat symptoms such as atrial fibrillation, particularly while directly under visualization. In particular, the device and assembly may be configured to facilitate the application of energy to the underlying tissue in a controlled manner while directly visualizing the tissue to monitor and confirm proper treatment. In general, the imaging and manipulation assembly may be advanced transvascularly, for example, through the inferior vena cava into the right atrium and into the patient's heart, where the hood is relative to the atrial septum. The hood may be placed and positioned, and the hood may be infused with saline to remove blood from the inside and observe the underlying tissue surface.

  Once the hood is desirably positioned over the foveal fossa, a penetrating device, such as a hollow needle, may be advanced through the hood from the catheter and penetrate the atrial septum until access to the left atrium. The guide wire may then be advanced through the penetrating device and introduced into the left atrium where it may be further advanced into one of the pulmonary veins. When the guidewire crosses the atrial septum into the left atrium, the penetrating device may be withdrawn, or the hood may be further retracted to its thin structure, and the catheter and sheath are optionally withdrawn as well. While leaving the guidewire in place across the atrial septum. The dilator may be advanced along the guidewire to dilate the opening through the atrial septum and provide a larger transseptal opening for introduction of hoods and other instruments into the left atrium . Further examples of methods and devices for transseptal access are described in co-owned US patent application Ser. No. 11 / 763,399, filed Jun. 14, 2007, which is incorporated herein by reference in its entirety. Are shown and described in more detail. Such transseptal access methods and devices may be fully utilized with the methods and devices described herein, as practicable.

  As the hood is advanced into the left atrium and expanded therein, the indwelling catheter and / or hood is articulated and brought into contact with or placed over the pulmonary vein inlet. May be. When the hood is desirably positioned along the tissue surrounding the pulmonary veins, the open area in the hood allows blood to be visualized by a translucent or transparent fluid to directly visualize the underlying tissue so that the tissue can be cauterized. It may be removed. The ablation probe, which may be configured in a number of different shapes, is advanced into and through the hood while directly under visualization, against the tissue region of interest for ablation treatment May be contacted. One or more of the inlet portions may be cauterized either partially or completely around the opening to create a conductive block. In performing the ablation, the hood may be pressed against the tissue utilizing the indwelling catheter and the sheath steering and / or articulating capabilities. Alternatively and / or additionally, negative pressure may be generated in the hood by withdrawing clear fluid through the indwelling catheter to create a seal against the tissue surface. In addition, the hood may be advanced through the hood, such as a helical tissue grasper, utilizing one or more tissue graspers, further approached to the tissue and temporarily on the tissue. The anti-traction force may be generated by adhering.

  Because the hood allows direct visualization of the underlying tissue in the body, the hood can be used to visually confirm that the appropriate area of the tissue has been cauterized and / or that the tissue has been adequately cauterized. May be used. Visual monitoring and confirmation may be accomplished in real time during the procedure or after the procedure is complete. In addition, the hood may be utilized to post-operatively image tissue that has been cauterized in previous procedures to determine if proper tissue ablation has been achieved.

  In general, when cauterizing the underlying visualized tissue with the ablation probe, moving the ablation probe within the region defined by the hood and / or to the tissue region to be treated, such as around the pulmonary vein inlet By moving the hood itself, one or more entrances of the pulmonary veins or other tissue regions within the left atrium may be ablated. Visual monitoring of the ablation procedure not only provides real-time visual feedback to maintain contact between the probe and the tissue, but also as a label in the event that irreversible tissue damage may occur, real-time on the ablated tissue surface Also provides color feedback. This color change during lesion formation may be correlated with parameters such as impedance, time of ablation, applied power, and the like.

  In addition, real-time visual feedback also allows the user to accurately position the ablation probe and move it to a desired location along the tissue surface to generate an accurate lesion pattern. In addition, visual feedback also provides a safety mechanism that allows the user to visually detect endocardial collapse and / or complications such as vapor formation or bubble formation. In the event of endocardial collapse or complications, any resulting tissue debris is contained within the hood and the hood contents are aspirated proximally into the indwelling catheter before the debris is released into the body Can be removed from the body. The hood also provides a relatively isolated environment with little or no blood to reduce the risk of clotting. The replacement fluid may also provide a cooling mechanism for the tissue surface and prevent overheating by introducing and removing saline through the hood.

  Upon completion of the ablation procedure, a hood to visually assess post-ablation lesions for adjacent lesion formation and / or for visual confirmation of endocardial disruption by identifying crater formation or coagulated or charred tissue May be used. If determined to be desirable or necessary during visual inspection, the tissue area around the pulmonary vein inlet or other tissue areas may be cauterized again without the need to withdraw or reintroduce the ablation device .

  A number of different ablation instruments may be utilized to cauterize the tissue visualized in the hood. For example, an ablation probe having at least one ablation electrode utilizing radio frequency (RP), microwave, ultrasound, laser, cryoablation, etc. is advanced into the open area of the hood, for example, through an indwelling catheter. May be allowed. Alternatively, various structures of ablation probes, such as linear or annular ablation probes, may be utilized depending on the desired lesion pattern and the area of tissue to be ablated. In addition, ablation electrodes may be similarly disposed on various areas of the hood.

  Ablation treatment under direct visualization may also be accomplished utilizing alternative visualization catheters that may additionally provide catheter stability with respect to dynamically moving tissue and blood flow. For example, one or more grasping support members may be passed through the catheter and placed from the hood, allowing the hood to be walked or moved along the tissue surface of the ventricle. Other variations may also utilize an intra-atrial balloon that occupies a relatively large volume of the left atrium and provide direct visualization of the tissue surface.

  A number of safety mechanisms may also be utilized. For example, to prevent inadvertent penetration or ablation of an ablation instrument from damaging adjacent tissue structures such as the esophagus, a light source or ultrasound transducer is inserted orally into the esophagus and the catheter light source is proximal or adjacent to the heart. Can be attached to or passed through a catheter that can be advanced until it is positioned. During an endovascular ablation procedure in the left atrium, the operator can use an imaging element to visually detect (or through ultrasound, etc.) the light source in the form of a background glow behind the ablated tissue as an indication of the location of the esophagus May be used. Another safety measure that may be utilized during tissue ablation is the use of color changes in the tissue being cauterized. One particular advantage of the direct visualization system described herein is the ability to observe and monitor tissue in real time and in detailed colors.

  The devices and methods described herein provide a number of advantages over previous devices. For example, cauterizing the pulmonary vein inlet and / or endocardial tissue under direct visualization can provide real-time visual feedback about contact between the ablation probe and the tissue surface, as well as the accuracy of the ablation probe that produces the desired lesion pattern Provides visual feedback about correct position and movement.

  Real-time visual feedback is also provided to confirm the position of the hood within the atrium itself by visualizing anatomical landmarks such as the pulmonary vein entrance or left atrial appendage location, left atrial septum, and the like.

  Real-time visual feedback is further provided for early detection of endocardial collapse and / or complications, such as visual detection of vapor or bubble formation. Real-time visual feedback is additionally provided for color feedback of cauterized endocardial tissue as an indicator when irreversible tissue damage occurs by allowing detection of tissue color changes .

  In addition, the hood itself provides a relatively isolated environment with little or no blood to reduce the risk of clotting. The replacement fluid may also provide a cooling mechanism for the tissue surface to prevent overheating.

  When the ablation procedure is complete, direct visualization further provides the ability to visually inspect adjacent lesion formation as well as the color difference of the tissue surface. Also, visual inspection of endocardial disruption and / or complications is possible, eg, cauterized tissue is examined for visual confirmation of the presence of tissue craters or coagulated blood on the tissue.

  If endocardial disruption and / or complications are detected, the hood also contains disintegration and provides a barrier or membrane for rapid drainage of tissue debris. In addition, the hood may be the entrance of the pulmonary vein, for example, by generating a negative pressure in the space defined within the hood to draw or aspirate tissue to be ablated against the hood for reliable contact. Provide for the establishment of stable contact with a tissue or other target tissue.

  When treating symptoms such as cardiac arrhythmia, atrial flutter, ventricular fibrillation, ablation probes may be introduced into tissue imaging and manipulation catheters, and the ablation process is monitored under direct visualization as described above. May be. In addition to visualization, additional features or instruments may be utilized with the catheter to detect tissue parameters and further monitor the ablation procedure before, during, and / or after the ablation process. For example, parameters such as the detection of the thickness, temperature, impedance characteristics of sinusoidal tissue regions may also be detected and monitored.

  One mechanism for detecting such parameters has a temperature sensor positioned inside and projecting from one or more corresponding probe shaft ends that may be advanced through the hood. Including the use of one or more ablation needle electrodes. These ablation electrodes may penetrate into the tissue and cauterize while monitoring the temperature of the treated tissue. In addition, the ablation electrode may also be configured with various structures for generating different lesion patterns, eg, linear, annular, etc. In addition to temperature sensing, the needle ablation electrode is also configured to sense tissue impedance so that when the needle electrode is advanced through or completely through the tissue to be treated. May be able to determine.

  The transmural needle assembly itself may generally comprise a distal tip having a probe and optional integrated ablation capability, and a catheter body connecting the probe to the handle assembly. The handle assembly generally may include a needle sinus depth indicator and an actuator, eg, a push / rotate knob, to advance or retract the distal transmural needle probe. The needle body itself may have a diameter of, for example, 0.005 inches, and the outer diameter thin wall needle has a plurality of pores or openings defined along the needle body. The outer surface of the needle may also be largely insulated except for a short exposed portion at the distal traumatic end, eg, the penetrating tip. Proximal to the needle is an ablation surface that can be incorporated to provide ablation energy. In addition, the sensor assembly housed within the needle lumen may include one or more sensors for detecting and monitoring various tissue parameters such as temperature, impedance, and the like.

  As the transmural needle is advanced into the target tissue and pierced, the impedance sensor may immediately detect an increase in impedance due to a difference in intrinsic material properties between blood and tissue. This detected change in impedance alerts the user that the transmural needle is in contact with the tissue. The impedance detected by the sensor is also verified from the standard impedance value determined by the tissue resistivity and electrode geometry, and compared with the predicted impedance of the target tissue to verify whether the needle has been inserted into the desired tissue. Can be used to

  As the ablation electrode begins to cauterize the tissue, the thin layer of saline that is injected and formed around the needle in the tissue may act as a conductive medium to carry radiant energy to additional tissue surfaces. This in turn helps to generate wider lesions using the same amount of power at the ablation electrode without tissue desiccation and / or blood clotting.

FIG. 4 shows a side view of one variation of a tissue imaging device during deployment from a sheath or delivery catheter. 1B shows the indwelling tissue imaging device of FIG. 1A having an optionally expandable hood or sheath attached to an imaging and / or diagnostic catheter. An end view of an indwelling image device is shown. For example, the apparatus of FIGS. 1A-1C with an additional lumen for the passage of a guidewire through the interior. For example, the apparatus of FIGS. 1A-1C with an additional lumen for the passage of a guidewire through the interior. For example, the apparatus of FIGS. 1A-1C with an additional lumen for the passage of a guidewire through the interior. FIG. 6 illustrates an example of a detained tissue imaging device positioned relative to or adjacent to the tissue being imaged and the flow of fluid, such as saline, that replaces blood from within the expandable hood. FIG. 6 illustrates an example of a detained tissue imaging device positioned relative to or adjacent to the tissue being imaged and the flow of fluid, such as saline, that replaces blood from within the expandable hood. Fig. 4 illustrates an articulatable imaging assembly that may be operated via a push-pull wire or by computer control. Each shows an steerable instrument in which an articulatable delivery catheter may be steered within an imaging hood or the distal portion of the indwelling catheter itself may be steered. Each shows an steerable instrument in which an articulatable delivery catheter may be steered within an imaging hood or the distal portion of the indwelling catheter itself may be steered. FIG. 6 shows another variation of a side view and a transverse end view with off-axis imaging capability, respectively. FIG. 6 shows another variation of a side view and a transverse end view with off-axis imaging capability, respectively. FIG. 6 shows another variation of a side view and a transverse end view with off-axis imaging capability, respectively. FIG. 3 shows an exemplary diagram of an example tissue imaging device that is transvascularly advanced into the heart to image a tissue region within the atrium. FIG. 6 illustrates an indwelling catheter having one or more optional inflatable balloons or anchors for stabilizing the device during the procedure. FIG. 6 illustrates an indwelling catheter having one or more optional inflatable balloons or anchors for stabilizing the device during the procedure. FIG. 6 illustrates an indwelling catheter having one or more optional inflatable balloons or anchors for stabilizing the device during the procedure. Fig. 6 illustrates a variation of the anchoring mechanism, such as a helical tissue penetrating device, for temporarily stabilizing the imaging hood against the tissue surface. Fig. 6 illustrates a variation of the anchoring mechanism, such as a helical tissue penetrating device, for temporarily stabilizing the imaging hood against the tissue surface. FIG. 6 shows another variation of securing the imaging hood having one or more tubular support members integrated with the imaging hood, each support member having an interior for advancing the helical tissue anchor therein. A lumen through may be defined. Fig. 4 illustrates an exemplary example of one variation of a method that may use a tissue imaging device with an imaging device. Fig. 4 shows a further illustration of a hand-held variant of the fluid delivery and tissue manipulation system. An example of capturing several images of a tissue in a plurality of regions is illustrated. An example of capturing several images of a tissue in a plurality of regions is illustrated. An example of capturing several images of a tissue in a plurality of regions is illustrated. FIG. 6 shows a chart illustrating how the fluid pressure in the imaging hood can be coordinated with the surrounding blood pressure, the fluid pressure in the imaging hood may be coordinated with the blood pressure or adjusted based on pressure feedback from the blood May be. FIG. 6 shows a chart illustrating how the fluid pressure in the imaging hood can be coordinated with the surrounding blood pressure, the fluid pressure in the imaging hood may be coordinated with the blood pressure or adjusted based on pressure feedback from the blood May be. FIG. 6 shows another variation of a side view of a tissue imaging device having an imaging balloon in an expandable hood. Fig. 5 shows another variation of tissue imaging device that utilizes a translucent or transparent imaging balloon. FIG. 6 illustrates another variation where a flexible expandable or stretchable membrane may be incorporated into the imaging hood to vary the amount of fluid dispensed. FIG. 6 illustrates another variation where an imaging hood may be partially or selectively placed from a catheter to vary the area of tissue being visualized as well as the amount of fluid dispensed. FIG. 6 illustrates another variation where an imaging hood may be partially or selectively placed from a catheter to vary the area of tissue being visualized as well as the amount of fluid dispensed. FIG. 5 shows another exemplary exemplary side and cross-sectional view, respectively, where infused fluid may be drawn back into the device to minimize fluid input into the body being treated. FIG. 5 shows another exemplary exemplary side and cross-sectional view, respectively, where infused fluid may be drawn back into the device to minimize fluid input into the body being treated. Various structures and methods for configuring a thin imaging hood for delivery and / or placement are shown. Various structures and methods for configuring a thin imaging hood for delivery and / or placement are shown. Various structures and methods for configuring a thin imaging hood for delivery and / or placement are shown. Various structures and methods for configuring a thin imaging hood for delivery and / or placement are shown. Figure 2 shows an imaging hood having a frame or support that expands in a spiral. Figure 2 shows an imaging hood having a frame or support that expands in a spiral. FIG. 4 illustrates another imaging hood having one or more hood support members that are pivotally attached to an indwelling catheter at its proximal end integral with the hood membrane. FIG. 4 illustrates another imaging hood having one or more hood support members that are pivotally attached to an indwelling catheter at its proximal end integral with the hood membrane. Fig. 4 shows yet another variation of an imaging hood having at least two or more longitudinally positioned support members that support the imaging hood membrane, wherein the support member is via torque, traction, or pushing force, Moveable relative to each other. Fig. 4 shows yet another variation of an imaging hood having at least two or more longitudinally positioned support members that support the imaging hood membrane, wherein the support member is via torque, traction, or pushing force, Moveable relative to each other. The distal portion of the indwelling catheter shows another variation where there may be several pivot members that form a tubular shape in its thin structure. The distal portion of the indwelling catheter shows another variation where there may be several pivot members that form a tubular shape in its thin structure. Fig. 5 shows another variation where the distal portion of the indwelling catheter may be made from a flexible metal or polymeric material to form a radially expandable hood. Fig. 5 shows another variation where the distal portion of the indwelling catheter may be made from a flexible metal or polymeric material to form a radially expandable hood. FIG. 6 illustrates another variation where an imaging hood may be formed from a plurality of overlapping hood members that are on top of each other in an overlapping pattern. FIG. 6 illustrates another variation where an imaging hood may be formed from a plurality of overlapping hood members that are on top of each other in an overlapping pattern. Fig. 5 shows another example of an expandable hood that is highly compatible with tissue anatomy with varying terrain. Fig. 5 shows another example of an expandable hood that is highly compatible with tissue anatomy with varying terrain. FIG. 6 illustrates yet another example of an expandable hood having a number of optional electrodes placed around the contact edge or lips of the hood to sense tissue contact or detect arrhythmias. FIG. 6 illustrates another variation of adapting the imaging hood to the underlying tissue where an inflatable contact edge may be disposed around the periphery of the imaging hood. A variation of the system is shown that may be equipped with a transducer for detecting the presence of blood that oozes back into the imaging hood. A variation type of an imaging hood equipped with sensors for detecting various physical parameters is shown, and the sensor may be installed around the outer surface of the imaging hood or in the imaging hood. A variation type of an imaging hood equipped with sensors for detecting various physical parameters is shown, and the sensor may be installed around the outer surface of the imaging hood or in the imaging hood. Fig. 6 illustrates a variation where the imaging hood may have one or more LEDs across the hood itself to provide illumination of the tissue being visualized. Fig. 6 illustrates a variation where the imaging hood may have one or more LEDs across the hood itself to provide illumination of the tissue being visualized. FIG. 6 illustrates another variation in which a separate lighting tool having one or more LEDs mounted thereon may be used in an imaging hood. FIG. 6 illustrates another variation in which a separate lighting tool having one or more LEDs mounted thereon may be used in an imaging hood. FIG. 4 illustrates an example of a method in which a treatment tool may be advanced through a tissue imaging device to treat a tissue region of interest. Fig. 3 shows another example of a helical treatment tool for treating a tissue region of interest. Fig. 4 illustrates a variation of how a treatment tool may be utilized with an expandable imaging balloon. FIG. 4 shows an alternative configuration of a therapeutic instrument that may be utilized, one variation being shown with an angled instrument arm and another variation being shown with an off-axis instrument arm. FIG. 4 shows an alternative configuration of a therapeutic instrument that may be utilized, one variation being shown with an angled instrument arm and another variation being shown with an off-axis instrument arm. FIG. 4 shows a side view and an end view, respectively, of an imaging system that may be utilized with an ablation probe. FIG. 4 shows a side view and an end view, respectively, of an imaging system that may be utilized with an ablation probe. FIG. 4 shows a side view and an end view, respectively, of an imaging system that may be utilized with an ablation probe. FIG. 6 shows a side view and an end view, respectively, of another variation of an imaging hood with an ablation probe, where the imaging hood may be sealed to adjust the temperature of the underlying tissue. FIG. 6 shows a side view and an end view, respectively, of another variation of an imaging hood with an ablation probe, where the imaging hood may be sealed to adjust the temperature of the underlying tissue. An example is shown in which the imaging fluid itself may be altered in temperature to facilitate various procedures on the underlying tissue. An example is shown in which the imaging fluid itself may be altered in temperature to facilitate various procedures on the underlying tissue. An example of a laser ring generator that may be utilized with an imaging system and an example of applying a laser ring generator in the left atrium of the heart to treat atrial fibrillation are shown. An example of a laser ring generator that may be utilized with an imaging system and an example of applying a laser ring generator in the left atrium of the heart to treat atrial fibrillation are shown. FIG. 6 illustrates an example of an extendable cannula that generally comprises an elongate tubular member that may be positioned within an indwelling catheter during delivery and then projected distally through an imaging hood and optionally beyond. FIG. 6 illustrates an example of an extendable cannula that generally comprises an elongate tubular member that may be positioned within an indwelling catheter during delivery and then projected distally through an imaging hood and optionally beyond. FIG. 6 illustrates an example of an extendable cannula that generally comprises an elongate tubular member that may be positioned within an indwelling catheter during delivery and then projected distally through an imaging hood and optionally beyond. FIG. 4 shows a side view and an end view, respectively, of an imaging hood having one or more tubular support members integrated with the hood for passing instruments or tools therethrough for treatment on underlying tissue. FIG. 4 shows a side view and an end view, respectively, of an imaging hood having one or more tubular support members integrated with the hood for passing instruments or tools therethrough for treatment on underlying tissue. For example, a method is illustrated that may utilize an illuminated probe that is temporarily positioned within the lumen of the coronary sinus to guide the imaging device to the region of interest within the ventricle. For example, a method is illustrated that may utilize an illuminated probe that is temporarily positioned within the lumen of the coronary sinus to guide the imaging device to the region of interest within the ventricle. Fig. 3 shows an imaging hood having a removable disc-shaped member for implantation on a tissue surface. Fig. 3 shows an imaging hood having a removable disc-shaped member for implantation on a tissue surface. FIG. 39 illustrates one method for implanting the removable disk of FIGS. 38A and 38B. FIG. 39 illustrates one method for implanting the removable disk of FIGS. 38A and 38B. FIG. 39 illustrates one method for implanting the removable disk of FIGS. 38A and 38B. 1 illustrates an imaging hood having an indwellable anchor assembly attached to a tissue contacting edge, and an assembly view of a suture or wire connected to the anchor and anchor, respectively. 1 illustrates an imaging hood having an indwellable anchor assembly attached to a tissue contacting edge, and an assembly view of a suture or wire connected to the anchor and anchor, respectively. 40 shows one method for deploying the anchor assembly of FIGS. 40A and 40B to close an opening or wound. 40 shows one method for deploying the anchor assembly of FIGS. 40A and 40B to close an opening or wound. 40 shows one method for deploying the anchor assembly of FIGS. 40A and 40B to close an opening or wound. 40 shows one method for deploying the anchor assembly of FIGS. 40A and 40B to close an opening or wound. FIG. 6 illustrates another variation where an imaging system may be fluidly coupled to a dialysis unit for filtering patient blood. FIG. 6 shows a variation of an indwelling catheter having a first indwellable hood and a second indwellable hood positioned distal to the first hood, the indwelling catheter also imaging tissue between the expanded hoods. There may be a side-view imaging element positioned between the first and second hoods. FIG. 6 shows a variation of an indwelling catheter having a first indwellable hood and a second indwellable hood positioned distal to the first hood, the indwelling catheter also imaging tissue between the expanded hoods. There may be a side-view imaging element positioned between the first and second hoods. FIG. 2 shows a side view and an end view of an indwelling catheter having a thin side imaging balloon with an uninflated thin structure, respectively. FIG. 2 shows a side view and an end view of an indwelling catheter having a thin side imaging balloon with an uninflated thin structure, respectively. FIGS. 44A and 44B show a side view, a top view, and an end view, respectively, of the inflated balloon of FIGS. 44A and 44B that define a visualization zone in the inflated balloon. FIGS. 44A and 44B show a side view, a top view, and an end view, respectively, of the inflated balloon of FIGS. 44A and 44B that define a visualization zone in the inflated balloon. FIGS. 44A and 44B show a side view, a top view, and an end view, respectively, of the inflated balloon of FIGS. 44A and 44B that define a visualization zone in the inflated balloon. FIG. 46 shows a side view and a transverse end view, respectively, of one method used in visualizing a lesion on a vessel wall within the inflated balloon visualization zone of FIGS. 45A-45C. FIG. 46 shows a side view and a transverse end view, respectively, of one method used in visualizing a lesion on a vessel wall within the inflated balloon visualization zone of FIGS. 45A-45C. 47A-47O transvascularly image and manipulate catheters into the heart and into the left atrium to cauterize the tissue surrounding the pulmonary vein inlet for treatment of atrial fibrillation. An example of the forward step is illustrated. FIG. 6 illustrates a partial cross-sectional view of a hood that is advanced into the left atrium to examine discontinuous lesions. FIG. 6 illustrates a partial cross-sectional view of a hood that is advanced into the left atrium to examine discontinuous lesions. FIG. 6 shows a modified perspective view of a transmural lesion ablation device in which a single RF ablation probe is inserted into the working channel of a tissue visualization catheter. FIG. 6 shows a side view of an apparatus for performing tissue ablation in a hood under real-time visualization. FIG. 6 shows a perspective view of an apparatus for performing tissue ablation in a hood under real-time visualization. FIG. 7 shows a perspective view of a variation of the device when an angular ablation probe is used for linear transmural lesion formation. FIG. 9 shows another perspective view of another variation of the device when an annular ablation probe is used for annular transmural lesion formation. FIG. 9 shows another perspective view of another variation of the transmural lesion ablation device with an annular RF electrode tip disposed on the outer periphery of the expandable membrane covering the hood of the tissue visualization catheter. FIG. 5 shows another perspective view of another variation of an expandable balloon with an annular RF electrode tip and no hood. FIG. 6 shows another variation of a perspective view of a transmural lesion ablation device with RF electrodes arranged circumferentially around the contact lips or edges of the hood. FIG. 6 shows a perspective view and a side view, respectively, of another variation of a transmural lesion ablation device with an ablation probe positioned within the hood that also includes at least one layer of a transparent elastic membrane covering the distal opening of the hood. . FIG. 6 shows a perspective view and a side view, respectively, of another variation of a transmural lesion ablation device with an ablation probe positioned within the hood that also includes at least one layer of a transparent elastic membrane covering the distal opening of the hood. . FIG. 6 shows another perspective view of another variation of a transmural lesion ablation device having an expandable linear ablation electrode strip inserted through a working channel of a tissue visualization catheter. FIG. 6 shows a perspective view of a device with a linear ablation electrode strip in its expanded structure. FIG. 7 shows another variation of a perspective view in which a fiber optic bundle coupled to a laser probe, eg, a laser generator, may be inserted through the working channel of a tissue visualization catheter and activated for ablation treatment. FIG. 7 shows another variation of a perspective view in which a fiber optic bundle coupled to a laser probe, eg, a laser generator, may be inserted through the working channel of a tissue visualization catheter and activated for ablation treatment. 56 shows the device of FIGS. 55A and 55B performing tissue ablation or transmural lesion formation under direct visualization while operating within the hood of the visualization catheter device. FIG. 4 shows a partial cross-sectional view of a tissue visualization catheter with an inflated occlusion balloon that temporarily occludes blood flow through the pulmonary vein while observing the entrance of the pulmonary vein. FIG. 6 shows a perspective view of first and second tissue graspers deployed through the hood to facilitate movement of the hood along the tissue surface. FIG. 6 illustrates a tissue visualization catheter that navigates around a body lumen, such as the left atrium of the heart, utilizing two tissue graspers to “walk” the catheter along the tissue surface. FIG. 6 illustrates a tissue visualization catheter that navigates around a body lumen, such as the left atrium of the heart, utilizing two tissue graspers to “walk” the catheter along the tissue surface. FIG. 6 illustrates a tissue visualization catheter that navigates around a body lumen, such as the left atrium of the heart, utilizing two tissue graspers to “walk” the catheter along the tissue surface. FIG. 9 shows a partial cross-sectional view of a tissue visualization catheter in a posterior bent position for accessing the right lower pulmonary vein entrance. FIG. 9 shows a partial cross-sectional view of a tissue visualization catheter that transvascularly accesses the left atrium via a transfemoral introduction through the aorta, aortic valve, left ventricle, and into the left atrium. FIG. 9 shows a side view of a first tissue grasper and a steeply bent back tissue visualization catheter accessing the right lower pulmonary vein entrance with a length of wire or suture configured as a pulley mechanism. FIG. 6 illustrates a tissue visualization catheter using a suture pulley mechanism to pull itself and access the lower right PV inlet at a steep angle. Fig. 4 illustrates a tissue visualization catheter before a suture is pulled. FIG. 4 illustrates a tissue visualization catheter being moved and approached toward the portal as the suture is pulled. FIG. 6 shows a partial cross-sectional view of a tissue visualization catheter having an intra-atrial balloon inflated in the left atrium. FIG. 6 shows a partial cross-sectional view with a fiberscope introduced inside the balloon. FIG. 5 shows a partial cross-sectional view with a fiberscope moving forward and articulating within a balloon. FIG. 4 shows a partial cross-sectional view of an intra-atrial balloon with a radiopaque fiducial marker and an ablation probe placed in the balloon. FIG. 6 shows a detailed side view of an ablation probe that is placed in a balloon and pierced through the balloon wall. The perspective view of the ablation needle which can be indwelled from a retracted position to an indwelling position is shown. The perspective view of the ablation needle which can be indwelled from a retracted position to an indwelling position is shown. FIG. 3 shows a perspective view of an ablation needle having a bipolar electrode structure. FIG. 4 illustrates a stabilization catheter accessing the left atrium with a stabilization balloon deployed in the right atrium and an example of articulation and translation capabilities that direct the hood toward the tissue region to be treated. FIG. 4 illustrates a stabilization catheter accessing the left atrium with a stabilization balloon deployed in the right atrium and an example of articulation and translation capabilities that direct the hood toward the tissue region to be treated. FIG. 4 illustrates a stabilization catheter accessing the left atrium with a stabilization balloon deployed in the right atrium and an example of articulation and translation capabilities that direct the hood toward the tissue region to be treated. FIG. 4 illustrates a stabilization catheter accessing the left atrium with a stabilization balloon deployed in the right atrium and an example of articulation and translation capabilities that direct the hood toward the tissue region to be treated. FIG. 4 illustrates a stabilization catheter accessing the left atrium with a stabilization balloon deployed in the right atrium and an example of articulation and translation capabilities that direct the hood toward the tissue region to be treated. Another variation of a stabilization catheter that accesses the left atrium with proximal and distal stabilization balloons placed around the atrial septum, and an articulation that directs the hood toward the tissue region to be treated and An example of parallel movement capability is illustrated. Another variation of a stabilization catheter that accesses the left atrium with proximal and distal stabilization balloons placed around the atrial septum, and an articulation that directs the hood toward the tissue region to be treated and An example of parallel movement capability is illustrated. Another variation of a stabilization catheter that accesses the left atrium with proximal and distal stabilization balloons placed around the atrial septum, and an articulation that directs the hood toward the tissue region to be treated and An example of parallel movement capability is illustrated. Another variation of a stabilization catheter that accesses the left atrium with proximal and distal stabilization balloons placed around the atrial septum, and an articulation that directs the hood toward the tissue region to be treated and An example of parallel movement capability is illustrated. Another variation of a stabilization catheter that accesses the left atrium with proximal and distal stabilization balloons placed around the atrial septum, and an articulation that directs the hood toward the tissue region to be treated and An example of parallel movement capability is illustrated. Intra-atrial dilation in the left atrium with a combination of proximal and distal stabilizing balloons placed around the atrial septum and a hollow needle that penetrates the balloon and places the hood outside the balloon Fig. 4 illustrates another variation of a stabilizing catheter accessing the left atrium with a balloon. Intra-atrial dilation in the left atrium with a combination of proximal and distal stabilizing balloons placed around the atrial septum and a hollow needle that penetrates the balloon and places the hood outside the balloon Fig. 4 illustrates another variation of a stabilizing catheter accessing the left atrium with a balloon. Intra-atrial dilation in the left atrium with a combination of proximal and distal stabilizing balloons placed around the atrial septum and a hollow needle that penetrates the balloon and places the hood outside the balloon Fig. 4 illustrates another variation of a stabilizing catheter accessing the left atrium with a balloon. Intra-atrial dilation in the left atrium with a combination of proximal and distal stabilizing balloons placed around the atrial septum and a hollow needle that penetrates the balloon and places the hood outside the balloon Fig. 4 illustrates another variation of a stabilizing catheter accessing the left atrium with a balloon. Intra-atrial dilation in the left atrium with a combination of proximal and distal stabilizing balloons placed around the atrial septum and a hollow needle that penetrates the balloon and places the hood outside the balloon Fig. 4 illustrates another variation of a stabilizing catheter accessing the left atrium with a balloon. Intra-atrial dilation in the left atrium with a combination of proximal and distal stabilizing balloons placed around the atrial septum and a hollow needle that penetrates the balloon and places the hood outside the balloon Fig. 4 illustrates another variation of a stabilizing catheter accessing the left atrium with a balloon. FIG. 4 illustrates a side view of a tissue visualization catheter indwelling an intra-atrial balloon with an articulatable imaging device that captures multiple images representing different portions of the ventricular wall from different angles. Fig. 4 schematically illustrates a mapping of a plurality of captured images that are processed to create a panoramic visual map of a ventricle. FIG. 6 shows a partial cross-sectional view of a tissue visualization catheter in the left atrium performing RF ablation, with a light source or ultrasound crystal source inserted orally into the esophagus to prevent esophageal perforation. Fig. 4 illustrates an image observed by a user before the ablation probe is activated. Fig. 4 illustrates an image observed by a user before the ablation probe is activated. FIG. 6 illustrates an image observed by a user of cauterized tissue that changes color as the ablation probe heats the underlying tissue. FIG. 6 illustrates an image observed by a user of cauterized tissue that changes color as the ablation probe heats the underlying tissue. FIG. 6 illustrates an image observed by a user of endocardial disruption and resulting tissue debris taken or contained within a hood. FIG. 6 illustrates an image observed by a user of endocardial disruption and resulting tissue debris taken or contained within a hood. Fig. 4 illustrates the drainage of a photographed tissue fragment into a catheter. FIG. 4 illustrates one method for attaching ablated tissue via a suction force applied to the underlying tissue to be ablated. FIG. 4 illustrates one method for attaching ablated tissue via a suction force applied to the underlying tissue to be ablated. FIG. 4 illustrates one method for attaching ablated tissue via a suction force applied to the underlying tissue to be ablated. FIG. 6 shows a perspective view of one variation of a tissue thickness monitoring and treatment device with a hood at the distal end, a sheath covering the body of the device, and a sensor probe extended from one or more lumens within the device. FIG. 4 shows a perspective view and a detailed perspective view, respectively, of a needle electrode having one or more temperature sensors positioned on and disposed within each of those shafts. FIG. 4 shows a perspective view and a detailed perspective view, respectively, of a needle electrode having one or more temperature sensors positioned on and disposed within each of those shafts. FIG. 6 shows a variation of a perspective view of a hood with an inflated balloon, for example with a contrast medium, in order to visualize the underlying tissue surface. FIG. 6 illustrates a perspective view of one method in which a balloon may be utilized to achieve ablation treatment. FIG. 6 illustrates a perspective view of one method in which a balloon may be utilized to achieve ablation treatment. FIG. 6 illustrates a perspective view of one method in which a balloon may be utilized to achieve ablation treatment. FIG. 6 illustrates a perspective view of one method in which a balloon may be utilized to achieve ablation treatment. FIG. 6 illustrates a perspective view of one method in which a balloon may be utilized to achieve ablation treatment. FIG. 6 illustrates a perspective view of one method in which a balloon may be utilized to achieve ablation treatment. Details of the hood in contact with the tissue surface with the flow of saline injected into the hood while creating a transmural lesion on the target tissue wall where the sensor and treatment probe are retracted proximally after treatment A side view is illustrated. Details of the hood in contact with the tissue surface with the flow of saline injected into the hood while creating a transmural lesion on the target tissue wall where the sensor and treatment probe are retracted proximally after treatment A side view is illustrated. Details of the hood in contact with the tissue surface with the flow of saline injected into the hood while creating a transmural lesion on the target tissue wall where the sensor and treatment probe are retracted proximally after treatment A side view is illustrated. Details of the hood in contact with the tissue surface with the flow of saline injected into the hood while creating a transmural lesion on the target tissue wall where the sensor and treatment probe are retracted proximally after treatment A side view is illustrated. Details of the hood in contact with the tissue surface with the flow of saline injected into the hood while creating a transmural lesion on the target tissue wall where the sensor and treatment probe are retracted proximally after treatment A side view is illustrated. Details of the hood in contact with the tissue surface with the flow of saline injected into the hood while creating a transmural lesion on the target tissue wall where the sensor and treatment probe are retracted proximally after treatment A side view is illustrated. FIG. 6 illustrates a partial cross-sectional view of a treatment probe that generates a transmural lesion in the right atrium as well as in the left atrium. FIG. 6 illustrates a partial cross-sectional view of a treatment probe that generates a transmural lesion in the right atrium as well as in the left atrium. FIG. 6 illustrates a partial cross-sectional view of a treatment probe that generates a transmural lesion in the right atrium as well as in the left atrium. FIG. 6 shows a perspective view of a variation of a linearly arranged probe for generating a linear lesion. FIG. 6 shows a perspective view of a variation of a linearly arranged probe for generating a linear lesion. FIG. 6 illustrates yet another structure that can generate an annular lesion in a single step via the ablation needle probe tip. FIG. FIG. 6 illustrates yet another structure that can generate an annular lesion in a single step via the ablation needle probe tip. FIG. FIG. 7 shows another variation of the assembly view of the transmural tissue parameter sensing needle with an enlarged view of the distal tip and proximal handle. FIG. 7 shows another variation of the assembly view of the transmural tissue parameter sensing needle with an enlarged view of the distal tip and proximal handle. FIG. 7 shows another variation of the assembly view of the transmural tissue parameter sensing needle with an enlarged view of the distal tip and proximal handle. A detailed perspective view of the probe is shown. Fig. 4 schematically illustrates impedance sensed using two simple impedance electrodes. Fig. 4 schematically illustrates impedance sensed by a high impedance bioamplifier. FIG. 6 is a perspective view of a fiber optic temperature sensor that monitors a change in color of a dye thermal layer as the dye changes from a first color indicating a first temperature to a second color indicating a second temperature. Illustrated. FIG. 6 is a perspective view of a fiber optic temperature sensor that monitors a change in color of a dye thermal layer as the dye changes from a first color indicating a first temperature to a second color indicating a second temperature. Illustrated. 2 shows a graph illustrating the relationship between light intensity versus time fluorescence decay rate τ. 2 shows a graph illustrating the relationship between decay rate time and temperature. FIG. 6 shows a perspective view of a transmural handle assembly. FIG. 4 illustrates a transmural subsurface probe in the retracted position and a side view of the handle showing the position of the contracted needle, respectively. FIG. 4 illustrates a transmural subsurface probe in the retracted position and a side view of the handle showing the position of the contracted needle, respectively. FIG. 4 illustrates a transmural subsurface probe that is partially advanced into tissue while sensing impedance, and a side view of the handle showing the needle penetration depth, respectively. FIG. 4 illustrates a transmural subsurface probe that is partially advanced into tissue while sensing impedance, and a side view of the handle showing the needle penetration depth, respectively. FIG. 6 illustrates a transmural subsurface probe that is fully sinned into tissue and injecting saline, and a side view of the handle showing the position of the deployed needle, respectively. FIG. 6 illustrates a transmural subsurface probe that is fully sinned into tissue and injecting saline, and a side view of the handle showing the position of the deployed needle, respectively. FIG. 4 illustrates a gradient of heated tissue extending from an electrode disposed on the catheter body to a temperature sensor in the needle. FIG. 4 illustrates a gradient of heated tissue extending from an electrode disposed on the catheter body to a temperature sensor in the needle. Shown are perspective views of the probe and catheter body, respectively, advanced through the indwelling catheter, into and through the hood, and cauterize and / or detect tissue parameters. Shown are perspective views of the probe and catheter body, respectively, advanced through the indwelling catheter, into and through the hood, and cauterize and / or detect tissue parameters. FIG. 9 shows another variation of a perspective view having a plurality of transmural needles arranged in a ring structure along a support ring positioned around the circumference of the hood opening. FIG. 9 shows another variation of a perspective view having a plurality of transmural needles arranged in a ring structure along a support ring positioned around the circumference of the hood opening. FIG. 6 shows a perspective view of a plurality of transmural needles arranged in a linear structure along a linear ablation electrode. FIG. 6 shows a perspective view of a plurality of transmural needles arranged in a linear structure along a linear ablation electrode. 90C illustrates the device of FIGS. 90A and 90B positioned over tissue for treatment and / or detection. FIG. 7 shows a detailed perspective view of another variation of a transmural subsurface probe where several additional temperature sensors may be positioned along the length of the needle. FIG. 4 illustrates a transmural subsurface probe fully penetrated into tissue while sensing temperature along the needle, and a side view of the handle showing the position of the deployed needle, respectively. FIG. 4 illustrates a transmural subsurface probe fully penetrated into tissue while sensing temperature along the needle, and a side view of the handle showing the position of the deployed needle, respectively. FIG. 6 illustrates yet another variation of a transmural subsurface probe including an intramural cooling needle with a cooling probe that may be advanced from a catheter body adjacent to the probe and penetrated into tissue. FIG. 93D illustrates the device of FIG. 93A positioned over tissue for treatment and / or detection. FIG. 6 shows another side view of another variation of a transmural subsurface probe with multiple impedance and temperature sensors along the needle. FIG. 6 shows a side view and a perspective view, respectively, of another variation of a transmural subsurface probe attached circumferentially and distally on the lumen. FIG. 6 shows a side view and a perspective view, respectively, of another variation of a transmural subsurface probe attached circumferentially and distally on the lumen. FIG. 6 shows a modified side view of a transmural subsurface probe at the distal end of an ablation probe capable of pivoting. FIG. 9 shows a side view and an end view, respectively, of another variation of a transmural needle with the needle protruding radially from the side of the catheter electrode. FIG. 9 shows a side view and an end view, respectively, of another variation of a transmural needle with the needle protruding radially from the side of the catheter electrode. FIG. 6 shows another variation of a transmural needle having a helical structure instead of a straight needle structure, and a side view of a needle that produces a relatively wide lesion in tissue. FIG. 6 shows another variation of a transmural needle having a helical structure instead of a straight needle structure, and a side view of a needle that produces a relatively wide lesion in tissue. FIG. 6 shows yet another variation of the transmural needle with one or more transparent visualization balloons fixed along the length of the transmural needle. Fig. 4 shows a modified side view and a detailed side view of a transmural subsurface probe positioned on a robot precision control system, respectively. Fig. 4 shows a modified side view and a detailed side view of a transmural subsurface probe positioned on a robot precision control system, respectively.

DETAILED DESCRIPTION OF THE INVENTION The tissue imaging and manipulation device described below provides a live real-time image of a tissue region within a body lumen, such as the heart, that is filled with blood that flows dynamically through it. It is also possible to provide intravascular tools and instruments for performing various procedures on the imaged tissue region. Such devices can be used in various procedures, such as facilitating transseptal access to the left atrium, coronary sinus cannulation, diagnosis of valve regurgitation / stenosis, valvuloplasty, atrial appendage, among other procedures. It may be used for closed, pro-arterial focal ablation.

  One variation of tissue access and imaging device is shown in the detailed perspective view of FIGS. 1A-1C. As shown in FIG. 1A, tissue imaging and manipulation assembly 10 may be delivered transvascularly through a patient's body in a thin configuration via a delivery catheter or sheath 14. When treating tissue such as the mitral valve located in the outflow tract of the left atrium of the heart, it is generally desirable to enter or access the left atrium while minimizing trauma to the patient. To achieve such access non-operatively, one conventional approach is to puncture the atrial septum from the right atrium to the left atrium in a procedure commonly referred to as a transseptal procedure or septotomy. With steps to do. For procedures such as percutaneous valve repair and replacement, transseptal access to the left atrium of the heart generally introduces a larger device into the venous system than can be percutaneously introduced into the arterial system May be possible.

  When the imaging and manipulation assembly 10 is ready to be utilized for imaging tissue, the imaging hood 12 is advanced relative to the catheter 14 as indicated by the arrow and from the distal opening of the catheter 14. It may be detained. Once indwelled, the imaging hood 12 may be unconstrained and expanded or opened into the indwelling imaging structure, as shown in FIG. 1B. The imaging hood 12 may be made from a variety of flexible or compatible biocompatible materials including, but not limited to, polymeric, plastic, or woven materials, for example. One example of a woven material is aramid, which can be made into a thin, eg, less than 0.001 inch, Kevlar® that maintains sufficient integrity for applications as described herein. Trademark) (EI du Pont de Nemours, Wilmington, DE). In addition, the imaging hood 12 is made from a translucent or opaque material in a variety of different colors to optimize or mitigate reflected light from the surrounding fluid or structure, i.e., anatomical or mechanical structures or instruments. Also good. In any case, the imaging hood 12 may be made in a uniform structure or a structure supported by a scaffold. In this case, a scaffold made of a shape memory alloy such as Nitinol, spring steel, or plastic is used. It may be made of and covered with a polymer, plastic or textile material. Accordingly, the imaging hood 12 is any of a wide variety of barriers or membrane structures that may generally be used to limit the replacement of blood or the like from a selected volume of body lumen or ventricle. May be provided. In the exemplary embodiment, the volume within the inner surface 13 of the imaging hood 12 is significantly smaller than the volume of the hood 12 between the inner surface 13 and the outer surface 11.

  The imaging hood 12 may be attached to an indwelling catheter 16 that may be translated at the junction 24 independent of the indwelling catheter or sheath 14. Attachment of the joining portion 24 may be accomplished through any number of conventional methods. Indwelling catheter 16 may define fluid delivery lumen 18 as well as imaging lumen 20, within which an optical imaging fiber or assembly may be placed to image tissue. If an open area or area 26 is defined by the imaging hood 12, when deployed, the imaging hood 12 expands to any number of shapes, eg, cylindrical, conical as shown, hemispherical, etc. May be. The open area 26 is an area in which a tissue area of interest may be imaged. The imaging hood 12 may also define an atraumatic contact lip or edge 22 for placement, or an adjoining area of tissue of interest. Further, the diameter of the imaging hood 12 at its maximum fully deployed diameter, for example, at the contact lip or edge 22 is typically larger than the diameter of the indwelling catheter 16 (but the diameter of the contact lip or edge 22). May be made to have a diameter of indwelling catheter 16 or less). For example, the diameter of the contact edge may range anywhere from 1 to 5 times the diameter of the indwelling catheter 16 (or more as practical). FIG. 1C shows an end view of the imaging hood 12 in the indwelling structure. Also shown are contact lips or edges 22 and fluid delivery lumen 18 and imaging lumen 20.

  The imaging and manipulation assembly 10 may additionally define a guidewire lumen therethrough, eg, a concentric or eccentric lumen, as shown in the side and end views of FIGS. 1D-1F, respectively. The indwelling catheter 16 defines a guidewire lumen 19 to facilitate passage of the system over or along the guidewire 17 that may be advanced transvascularly within the body lumen. Also good. The indwelling catheter 16 may then be advanced over the guidewire 17 as is generally known in the art.

  During operation, after the imaging hood 12 is deployed as shown in FIG. 1B and is desirably positioned relative to the tissue region to be imaged along the contact edge 22, the fluid completely fills the open region 26 and within the open region 26. The fluid may be pumped through the fluid delivery lumen 18 at a positive pressure until the fluid 28 is replaced. The displacement fluid flow may be laminarized to improve its removal effect and help prevent blood from re-entering the imaging hood 12. Alternatively, fluid flow may be initiated before placement is performed. The replacement fluid, also referred to herein as imaging fluid, may comprise any biocompatible fluid, such as saline, water, plasma, etc., that is sufficiently transparent and compared through the fluid. Visualization without distortion is possible. Alternatively or in addition, any number of therapeutic agents may be suspended in the liquid or pumped into the open area 26 and later into the heart and patient body and into it. The fluid itself may be provided that is passed through.

  As can be seen in the example of FIGS. 2A and 2B, the indwelling catheter 16 is manipulated to a sub-tissue region of interest to be imaged, in this example a portion of the annulus A of the mitral valve MV in the left atrium. The indwelling imaging hood 12 may be positioned with respect to or in the vicinity thereof. As seen in FIG. 2A, as the peripheral blood 30 flows around the imaging hood 12 and into the open area 26 defined within the imaging hood 12, the underlying ring A is obstructed by the opaque blood 30, It is difficult to observe through the imaging lumen 20. 2B, fluid 28 then intermittently or continuously through fluid delivery lumen 18 until blood 30 is at least partially, preferably completely, replaced from within open area 26. Alternatively, a translucent fluid 28 such as physiological saline may be injected with a pump.

  Although the contact edge 22 does not need to be in direct contact with the underlying tissue, the flow of clean fluid 28 from the open area 26 is maintained and significant backflow of blood 30 back into the open area 26 can be suppressed. As such, it is at least preferably delivered in close proximity to the tissue. The contact edge 22 is also typically made of a soft elastomeric material such as silicone or polyurethane of a certain degree of softness so that the contact edge 22 conforms to a non-uniform or rough underlying anatomical surface. May be useful to do. When the blood 30 is replaced from the imaging hood 12, an image of the underlying tissue can be observed through the clean fluid 30. This image may then be recorded or made available for real-time observation to perform a therapeutic procedure. The positive flow of fluid 28 may be maintained continuously, providing a clear view of the underlying tissue. Alternatively, fluid flow 28 may be stopped and can be used to image and record an unobstructed view of the tissue, at which point blood 30 may permeate into or reverse flow into imaging hood 12. The fluid 28 may be pumped temporarily or sporadically only until: This process may be repeated many times in the same tissue region or in multiple tissue regions.

  A number of articulation and operational controls may be utilized in desirably positioning the assembly in various areas within the patient's body. For example, as shown in the articulatable imaging assembly 40 of FIG. 3A, one or more push-pull wires 42 guide the distal end of the device in various directions 46 to visualize the imaging hood 12. Indwelling catheter 16 may be passed through for desired positioning adjacent to a region of tissue. Depending on the number of push-pull wires 42 that are positioned and utilized, the indwelling catheter 16 and imaging hood 12 may be articulated to any number of structures 44. The push-pull wires or wires 42 may be articulated from outside the patient's body via their proximal ends using one or more controls manually. Alternatively, the indwelling catheter 16 may be articulated under computer control, as further described below.

  Additionally or alternatively, an articulatable delivery catheter 48 that may be articulated via one or more push-pull wires and that has an imaging lumen and one or more working lumens may be used to place the indwelling catheter 16. It may be delivered through and into the imaging hood 12. With the distal portion of the articulatable delivery catheter 48 within the imaging hood 12, clean replacement fluid may be pumped through the delivery catheter 48 or indwelling catheter 16 to clean the area within the imaging hood 12. As shown in FIG. 3B, the articulatable delivery catheter 48 may be articulated within the imaging hood to obtain a better image of the tissue adjacent to the imaging hood 12. In addition, the articulatable delivery catheter 48 is articulated to allow the catheter 48 to be repositioned without repositioning the indwelling catheter 16 and recleaning the imaging area within the hood 12, as will be described in detail below. The instrument or tool being passed may be directed to a specific area of tissue being imaged through the imaging hood 12.

  Alternatively, rather than passing the indwelling catheter 16 through the articulatable delivery catheter 48, the distal portion of the indwelling catheter 16 itself is a distal end that is articulatable within the imaging hood 12, as shown in FIG. 3C. 49 may be provided. Directed imaging, instrument delivery, etc. may be accomplished through one or more lumens in the indwelling catheter 16 directly to a specific region of the underlying tissue that is imaged in the imaging hood 12.

  Visualization within imaging hood 12 may be accomplished through imaging lumen 20 defined through indwelling catheter 16 as described above. In such a configuration, visualization is available linearly, i.e., an image is generated from an area along the longitudinal axis distally defined by the indwelling catheter 16. As an alternative or in addition, as shown in FIG. 4A, an articulatable imaging assembly having a pivotable support member 50 is connected to, attached to, or passed through the indwelling catheter 16. Off-axis visualization may be provided for a defined longitudinal axis. The support member 50 may have an imaging element 52, such as a CCD or CMOS imager, or an optical fiber, attached at its distal end, the proximal end of which via a pivot connection 54. Connected to indwelling catheter 16.

  If more than one optical fiber is utilized for imaging, the optical fiber 58 may be passed through the indwelling catheter 16 and through the support member 50 as shown in the cross section of FIG. 4B. Use of the optical fiber 58 may provide an increased diameter size of one or several lumens 56 through the indwelling catheter 16 for passage of diagnostic and / or therapeutic tools through the interior. Alternatively, an electronic chip, such as an electro-coupled device (CCD) or CMOS imager, which is typically well known, may be utilized in place of the optical fiber 58, in which case the electronic imager is far from the indwelling catheter 16. The electronic wire is passed proximally to the indwelling catheter 16. Alternatively, the electronic imaging device may be wirelessly coupled to a receiver for wireless transmission of images. As described in more detail below, additional optical fibers or light emitting diodes (LEDs) can be used to provide illumination to the image or operating room. As shown in the cross section of FIG. 4C, the support member 50 is pivotally connected via a connection 54 so that the member 50 is positioned in a thin configuration within a channel or groove 60 defined in the distal portion of the catheter 16. May be placed in. During intravascular delivery of the indwelling catheter 16 through the patient's body, the support member 50 can be positioned in the channel or groove 60 and the imaging hood 12 is also in its thin structure. During visualization, the imaging hood 12 may be expanded to its deployed structure, and the support member 50 is deployed to its off-axis structure to image tissue adjacent to the hood 12, as shown in FIG. 4A. May be. Other structures for the support member 50 for off-axis visualization may be utilized as desired.

  FIG. 5 is an exemplary cross-sectional view of a heart H having a tissue region of interest being viewed through the imaging assembly 10. In this example, the delivery catheter assembly 70 may be introduced percutaneously into the patient's vasculature and advanced through the superior vena cava SVC and into the right atrium RA. The delivery catheter or sheath 72 may be articulated through the atrial septum AS and into the left atrium LA to observe or treat tissue, eg, the annulus A surrounding the mitral valve MV. As shown, the indwelling catheter 16 and imaging hood 12 are advanced out of the delivery catheter 72 and brought into contact or proximity to the tissue region of interest. In other examples, the delivery catheter assembly 70 may be advanced through the inferior vena cava IVC if so desired. In addition, other regions of the heart H, such as the right ventricle RV or the left ventricle LV, may also be accessed, imaged or treated by the imaging assembly 10.

  In accessing a region of the heart H or other part of the body, the delivery catheter or sheath 14 may comprise a conventional intravascular catheter or intraluminal delivery device. Alternatively, a robotically controlled delivery catheter may optionally be utilized with the imaging assembly described herein, in which case a computer controller 74 is used to control the connection and positioning of the delivery catheter 14. Also good. An example of a robotically controlled delivery catheter that may be utilized is further described in US Pat. Publication No. 2002/0087169 A1 of Block et al., Entitled “Flexible Instrument”, which is incorporated herein by reference in its entirety. It has been explained in detail. Hansen Medical, Inc. Other robotically controlled delivery catheters manufactured by (Mountain View, CA) may also be utilized with the delivery catheter 14.

  In order to facilitate stabilization of the indwelling catheter 16 during the procedure, one or more inflatable balloons or anchors 76 may be positioned along the length of the catheter 16, as shown in FIG. 6A. For example, when utilizing the transseptal access method across the atrial septum AS and into the left atrium LA, the inflatable balloon 76 is inflated from its low profile to its expanded structure, and the catheter 16 is in relation to the heart H. The position may be temporarily fixed or stabilized. FIG. 6B shows the inflated first balloon 78, while FIG. 6C also shows a second balloon 80 inflated proximal to the first balloon 78. In such a structure, the septum AS may be pushed or sandwiched between the balloons 78, 80 to temporarily stabilize the catheter 16 and the imaging hood 12. A single balloon 78 or both balloons 78, 80 may be used. Other alternatives may utilize an expandable mesh member, malecot, or any other temporarily expandable structure. After the procedure is completed, the balloon assembly 76 may be deflated or reconfigured to be thin for removal of the indwelling catheter 16.

  In order to further stabilize the position of the imaging hood 12 relative to the tissue surface being imaged, various fixation mechanisms may optionally be employed to temporarily hold the imaging hood 12 against the tissue. Such an anchoring mechanism may be particularly useful for imaging tissue that is susceptible to motion, for example, when imaging tissue in the heart chamber of a beating heart. A tool delivery catheter 82 having at least one instrument lumen and an optional visualization lumen may be delivered through the indwelling catheter 16 and into the expanded imaging hood 12. When the imaging hood 12 is brought into contact with the tissue surface T to be examined, an anchoring mechanism, such as a helical tissue penetrating device 84, passes through the tool delivery catheter 82, as shown in FIG. 7A, and the imaging hood. 12 may be passed through.

  The helical tissue engaging device 84 may be torqued from its proximal end outside the patient's body to temporarily secure itself in the underlying tissue surface T. When implanted within tissue T, the helical tissue engaging device 84 may be pulled proximally relative to the indwelling catheter 16, while the indwelling catheter 16 and imaging hood 12 are as indicated by the arrows in FIG. 7B. Then, it is pushed distally to gently push the contact edge or lips 22 of the imaging hood against the tissue T. The positioning of the tissue engaging device 84 may be temporarily locked to the indwelling catheter 16 to ensure a reliable positioning of the imaging hood 12 during a diagnostic or therapeutic procedure within the imaging hood 12. After the procedure, the tissue engaging device 84 may be removed from the tissue by applying torque to its proximal end in the opposite direction to remove the anchor from the tissue T and the indwelling catheter 16 repeats the anchoring process. It may be repositioned to another area of tissue that may be removed or removed from the patient's body. Tissue engagement device 84 may also be constructed from other known tissue engagement devices, such as, among other things, vacuum assist engagement or grasper assist engagement tools.

  Although a helical anchor 84 is shown, this is intended to be exemplary, and other types of temporary anchors, such as barbed or barbed anchors, grippers, etc. may be utilized. . Further, the tool delivery catheter 82 may be omitted entirely and the anchoring device may be delivered directly through the lumen defined through the indwelling catheter 16.

  In another variation where the tool delivery catheter 82 may be omitted entirely from the temporary anchor imaging hood 12, FIG. 7C illustrates one or more tubular support members 86 integrated with the imaging hood 12, For example, an imaging hood 12 having four supports 86 as shown is shown. Tubular support member 86 may define a lumen therethrough, each having a helical tissue engaging device 88 positioned therein. When the expanded imaging hood 12 is temporarily secured to the tissue, the helical tissue engagement device 88 may be pushed strongly distally and extend from the imaging hood 12, each proximal to it. Torque may be applied from the end to engage the underlying tissue T. Each of the helical tissue engaging devices 88 may be advanced through the length of the indwelling catheter 16 or positioned within the tubular support member 86 during delivery and placement of the imaging hood 12. Good. When the procedure in the imaging hood 12 is complete, each of the tissue engagement devices 88 may be removed from the tissue, and the imaging hood 12 may be repositioned to another region of tissue or removed from the patient's body. Good.

  An illustrative example of a tissue imaging assembly connected to a fluid delivery system 90 and an optional processor 98 and image recording device and / or viewer 100 is shown in FIG. 8A. The fluid delivery system 90 may generally include a pump 92 and an optional valve 94 for controlling the flow rate of fluid into the system. A fluid reservoir 96 that is fluidly connected to the pump 92 may hold fluid that is pumped through the imaging hood 12. An optional central processor or processor 98 may be in electrical communication with the fluid delivery system 90 to control flow parameters such as the flow rate and / or velocity of the pumped fluid. The processor 98 may also be in electrical communication with the image recording device and / or the viewer 100 for directly observing images of tissue received from within the imaging hood 12. The image recorder and / or viewer 100 may also be used to record not only the image, but also the location of the observed tissue region, if so desired.

  Optionally, a processor 98 may also be utilized to coordinate fluid flow and image capture. For example, the processor 98 may be programmed to provide fluid flow from the reservoir 96 until blood is replaced from the tissue region and a clear image is acquired. Once it is determined that the image is sufficiently clear, an image of the tissue may be taken automatically by the recording device 100, either visually by the practitioner or by a computer, and the pump 92 It may be automatically stopped or decelerated by the processor 98 to stop fluid flow into the patient. Other variations of fluid delivery and image capture are of course possible, and the above structure is intended to be exemplary rather than limiting.

  FIG. 8B shows a further illustration of a hand-held variation of the fluid delivery and tissue manipulation system 110. In this variation, the system 110 may have a housing or handle assembly 112 that can be held or manipulated by a physician from outside the patient's body. A fluid reservoir 114, shown in this variation as a syringe, is fluidly coupled to the handle assembly 112 and can be actuated via a pumping mechanism 116, such as a main screw. The fluid reservoir 114 may be a simple reservoir that is separated from the handle assembly 112 and fluidly coupled to the handle assembly 112 via one or more tubes. Fluid flow and other mechanisms are measured by the electronic controller 118.

  While the placement of the imaging hood 12 may be activated by a hood placement switch 120 located on the handle assembly 112, the dispensing of fluid from the reservoir 114 can be electrically coupled to the controller 118. May be actuated by a fluid indwelling switch 122. The controller 118 may also be electrically coupled to a wired or wireless antenna 124, optionally integrated with the handle assembly 112, as shown. The wireless antenna 124 may be recorded via, for example, Bluetooth® wireless technology (Bluetooth SIG, Inc., Bellevee, WA), RF, etc., for recording on the monitor 128 or for later observation. It can be used to wirelessly transmit an image taken from the imaging hood 12 to the receiver.

  Articulation control of the delivery catheter or sheath 14 that may deliver the indwelling catheter 16 or through the indwelling catheter 16 may be accomplished by computer control, as described above, in which case additional control along with the handle assembly 112 is provided. An apparatus may be used. In the case of manual articulation, the handle assembly 112 may incorporate one or more articulation controls 126 for manual manipulation of the position of the indwelling catheter 16. The handle assembly 112 may also define one or more instrument ports 130 through which a number of endovascular tools are provided for tissue manipulation and treatment within the imaging hood 12, as further described below. May be passed on. Moreover, in some procedures, fluid or debris can be removed from the imaging hood 12 for drainage from the patient's body, optionally by fluidly coupling the suction pump 132 to the handle assembly 112 or directly to the indwelling catheter 16. You may inhale it.

  As described above, fluid may be continuously pumped into the imaging hood 12 to provide a clear view of the underlying tissue. Alternatively, an unobstructed field of view of the tissue is imaged and recorded, at which point fluid flow may cease and blood may be allowed to soak into or flow back into the imaging hood 12. The fluid may be pumped temporarily or sporadically only until it becomes available. 9A-9C illustrate an example of taking several images of tissue in multiple regions. The indwelling catheter 16 may be desirably positioned and the imaging hood 12 is in place relative to the area of tissue being imaged, in this example, the tissue surrounding the mitral valve MV in the left atrium of the patient's heart. It may be detained and brought in. The imaging hood 12 may optionally be secured to tissue as described above and then cleaned by pumping imaging liquid into the hood 12. When sufficiently clean, the tissue may be visualized and an image may be taken by the control electronics 118. The first captured image 140 may be stored and / or transmitted wirelessly 124 to the monitor 128 for viewing by a physician, as shown in FIG. 9A.

  The indwelling catheter 16 may then be repositioned on the adjacent portion of the mitral valve MV, as shown in FIG. 9B, in which case the process is repeated for a second time for observation and / or recording. The image 142 may be taken. Again, the indwelling catheter 16 may be repositioned to another region of tissue, as shown in FIG. 9C, in which case a third image 144 may be taken for observation and / or recording. This procedure may be repeated as many times as necessary to take a comprehensive image of the tissue surrounding the mitral valve MV, or any other tissue region. When the indwelling catheter 16 and the imaging hood 12 are repositioned from tissue region to tissue region, the pump may stop during positioning and blood or surrounding fluid will be in the imaging hood 12 until the tissue is imaged. It may be possible to enter, in which case the imaging hood 12 may be cleaned as described above.

  As described above, when the imaging hood 12 is cleaned by pumping imaging fluid into the interior to remove blood or other body fluids, the fluid is continuously pumped and positive pressure is applied. The imaging fluid may be maintained in the hood 12 or the fluid flow into the hood 12 is decelerated or stopped when various parameters are detected or until a clear image of the underlying tissue is acquired. For this purpose, it may be pumped under computer control. The control electronics 118 may also be programmed to coordinate fluid flow into the imaging hood 12 with various physical parameters to maintain a clear image within the imaging hood 12.

  An example is shown in FIG. 10A, which shows a chart 150 illustrating how the fluid pressure in the imaging hood 12 can be coordinated with the surrounding blood pressure. Chart 150 shows circulatory blood pressure 156 that varies between diastolic pressure 152 and systolic pressure 154 over time T due to the beating motion of the patient's heart. Since the fluid pressure of the imaging fluid indicated by the drawing 160 in the imaging hood 12 may be automatically timed in response to the blood pressure change 160, the increased pressure is maintained in the imaging hood 12, which As always illustrated by the pressure difference at peak systolic pressure 158, it is always above blood pressure 156 by a slight increase ΔP. This pressure difference ΔP may be maintained in the imaging hood 12 over changes in the peripheral blood pressure, maintain the positive pressure of the imaging fluid in the imaging hood 12, and maintain a clear view of the underlying tissue. One advantage of maintaining a constant ΔP is a constant flow and maintenance of an unobstructed area.

  FIG. 10B shows a chart 162 illustrating another variation of the step of maintaining an unobstructed view of the underlying tissue, as described in more detail below, one or more sensors within the imaging hood 12 are shown. The pressure change in the imaging hood 12 may be sensed and correspondingly configured to increase the imaging fluid pressure in the imaging hood 12. This may result in a time delay ΔT, as illustrated by the transitional fluid pressure 160 relative to the circulating blood pressure 156, but the time delay ΔT can be ignored when maintaining a clear image of the underlying tissue. Good. This time delay is estimated by predicting when the next pressure wave peak will arrive, and increasing the pressure prior to the pressure wave by an amount of time equal to the above time delay, effectively offsetting the time delay. A prediction software algorithm can also be used to substantially eliminate.

  Variations in the flow pressure within the imaging hood 12 may be achieved in part due to the nature of the imaging hood 12. Inflatable balloons conventionally used to image tissue may be affected by changes in ambient blood pressure. On the other hand, the imaging hood 12 keeps a constant volume inside and is structurally not subject to changes in peripheral blood pressure, thus allowing an increase in pressure inside it. The material from which the hood 12 is made may also contribute to the way pressure is modulated in the hood 12. Harder hood materials such as high durometer polyurethane or nylon may help maintain an open hood when in place. On the other hand, a relatively lower durometer, such as a low durometer PVC or polyurethane, or a softer material may decompose at ambient flow pressure and may not adequately maintain an indwelling or expanded hood.

  Referring now to the imaging hood, other variations of the tissue imaging assembly may be utilized, as shown in FIG. 11A showing another variation with an additional imaging balloon 172 within the imaging hood 174. In this variation, an expandable balloon 172 having a transparent skin may be positioned within the imaging hood 174. Balloon 172 may be made of any extensible biocompatible material that has sufficient translucency to allow visualization through it. Once the imaging hood 174 has been placed against the tissue region of interest, the balloon 172 may be inflated with saline or a fluid, such as less preferred gas, until the balloon 172 is expanded until the blood is sufficiently replaced. May be satisfied. Thus, the balloon 172 may be expanded proximate to or in contact with the observed tissue region. Balloon 172 can also be filled with contrast agent and allowed to be viewed with fluoroscopy to aid in its positioning. It is then pumped into the imaging hood 174 via the balloon 172 and one or more optional fluid ports 176 that may be positioned proximal to the balloon 172 along a portion of the indwelling catheter 170. An imaging device, such as an optical fiber, positioned within the indwelling catheter 170 may be utilized to observe the tissue region through any additional fluid. Alternatively, balloon 172 may define one or more holes across its surface that allow infiltration or passage of the fluid contained therein to allow blood to exit and replace within imaging hood 174.

  FIG. 11B shows another alternative where the balloon 180 may be used alone. The balloon 180 attached to the indwelling catheter 178 may be filled with a fluid such as saline or contrast agent and is preferably allowed to be in direct contact with the tissue region to be imaged.

  FIG. 12A shows another alternative where the indwelling catheter 16 incorporates the imaging hood 12 and includes an additional flexible membrane 182 within the imaging hood 12 as described above. A flexible membrane 182 may be attached at the distal end of the catheter 16 and optionally at the contact edge 22. As described above, the imaging hood 12 may be utilized, and the membrane 182 may be placed from the catheter 16 in vivo or prior to placing the catheter 16 within the patient to reduce the volume within the imaging hood 12. Also good. The volume may be reduced or minimized to reduce the amount of fluid dispensed for visualization, or simply reduced depending on the area of tissue being visualized.

  FIGS. 12B and 12C illustrate that the imaging hood 186 can be retracted proximally within the indwelling catheter 184, or placed distally from the catheter 186, as shown, so that the volume of the imaging hood 186 and thus the dispensed fluid Yet another alternative that may vary in volume is shown. Imaging hood 186 can be seen in FIG. 12B as being partially deployed from a circumferentially defined lumen within catheter 184, such as, for example, annular lumen 188. The underlying tissue may be visualized with an imaging hood 186 that is only partially indwelled. Alternatively, as shown in FIG. 12C, imaging hood 186 ′ may be fully deployed by strongly pushing hood 186 ′ distally out of annular lumen 188. In this expanded configuration, the area of tissue that is visualized may be increased as the hood 186 'is expanded circumferentially.

  FIGS. 13A and 13B illustrate an imaging assembly that may utilize a fluid aspiration system to minimize the amount of liquid injected into a patient's heart or other body lumen during tissue visualization. FIG. 6 shows a perspective view and a cross-sectional side view of yet another variation of FIG. Indwelling catheter 190 in this variation may define an inner tubular member 196 that may be integral with indwelling catheter 190 or independently translatable. A fluid delivery lumen 198 defined through member 196 may be fluidly connected to an imaging hood 192 that may also define one or more open channels 194 across its contact lip region. Thus, fluid pumped through the fluid delivery lumen 198 may fill the open region 202 and replace any blood or other fluid or object inside it. As the clean fluid is pushed out of the open area 202, it may be drawn or drawn back through the one or more channels 194 and back into the indwelling catheter 190. Tubular member 196 may also define one or more additional actuation channels 200 for passage through any tool or visualization device.

  Upon placement of the imaging hood in the examples described herein, the imaging hood is optional when positioned or configured for thin delivery within the delivery catheter, as shown in the examples of FIGS. 14A-14D. The number of structures may be exhibited. These examples are intended to be illustrative and are not intended to limit the scope. FIG. 14A illustrates an example where the imaging hood 212 may be compressed within the catheter 210 by folding the hood 212 along a plurality of pleats. The hood 212 may also include a scaffold or frame 214 made of a superelastic or shape memory material or alloy, such as Nitinol, Elgiloy, shape memory polymer, electroactive polymer, or spring steel. The shape memory material may act to expand or place the imaging hood 212 in its expanded structure when pushed strongly in the direction of the arrow from the restraint of the catheter 210.

  FIG. 14B shows another example in which the imaging hood 216 may be expanded or placed from the catheter 210 from a folded overlapping structure. A frame or scaffold 214 may also be utilized in this example. FIG. 14C shows yet another example where the imaging hood 218 may be rolled, inverted, or flipped over itself for placement. In yet another example, FIG. 14D shows a structure where the imaging hood 220 may be made from an extremely flexible material that allows the hood 220 to be simply compressed into a thin shape. From this thin compressed shape, by simply releasing the hood 220, it can be expanded to its indwelling structure, especially when shape memory or superelastic materials such as Nitinol scaffolds or frames are utilized in the configuration. May be possible.

  FIGS. 15A and 15B illustrating a helically expanding frame or support 230 illustrate another variation of the step of expanding the imaging hood. In the constrained thin structure shown in FIG. 15A, the helical frame 230 may be integrated with the membrane of the imaging hood 12. As shown in FIG. 15B, when freely expandable, the helical frame 230 may expand into a conical or tapered shape. The helical frame 230 may alternatively be made of nitinol activated by heating, allowing it to expand upon application of current.

  FIGS. 16A and 16B show yet another variation where the imaging hood 12 may include one or more hood support members 232 integrated with the hood membrane. These longitudinally attached support members 232 may be pivotally attached to the indwelling catheter 16 at their proximal ends. One or more puller wires 234 are passed through the length of the indwelling catheter 16 and through one or more openings 238 defined in the indwelling catheter 16 to corresponding support members 232 at the attachment point 236 of the puller wire. May extend proximally into the imaging hood 12 into the attachment. Support member 232 may be made of plastic or metal such as stainless steel. Alternatively, the support member 232 may be made of a superelastic or shape memory alloy such as Nitinol that may self-expand into its indwelling structure without the use or need of a pull wire. Nitinol activated by heating that expands upon application of thermal or electrical energy may also be utilized. In another alternative, the support member 232 may be constructed as an inflatable lumen utilizing, for example, a PET balloon. From its thin delivery structure shown in FIG. 16A, one or more pull wires 234 are pulled from their proximal ends that are outside the patient's body, and corresponding support members 232 as shown in FIG. 16B. The imaging hood 12 may be expanded by pulling the indwelling structure. To reconfigure the imaging hood 12 back to its low profile, the indwelling catheter 16 may be pulled proximally into the restraining catheter, or the puller wire 234 may simply be pushed distally to cause the imaging hood 12 to be reconfigured. It may be decomposed.

  FIGS. 17A and 17B show yet another variation of the imaging hood 240 having at least two or more longitudinally positioned support members 242 that support the imaging hood membrane. Each support member 242 has a cross support member 244 that extends diagonally therebetween and is pivotally attached to the support member 242. Each of the cross support members 244 may be pivotally attached to each other where they intersect between the support members 242. A jack or screw member 246 may be connected to each cross support member 244 at this intersection, and a torque applying member, such as a torque applyable wire 248, is connected to each jack or screw member 246 and through the indwelling catheter 16. It may extend proximally outside the patient's body. From outside the patient's body, the torqueable wire 248 may be torqued to rotate the jack or screw member 246, which in turn causes the cross support members 244 to be angled relative to each other. Urge, thereby urging the support members 242 away from each other. Thus, the imaging hood 240 may transition from its thin shape shown in FIG. 17A to its expanded outer shape shown in FIG. 17B and return to its thin shape by applying torque to the wire 248.

  18A and 18B show yet another variation of the imaging hood and its placement. As shown, the distal portion of the indwelling catheter 16 has several pivot members 250, for example, two to four sections that form a tubular shape in its low-profile configuration, as shown in FIG. 18A. There may be. When radially pivoted around the indwelling catheter 16, the pivot member 250 opens into an indwelling structure having an extensible or expandable membrane 252 extending in the middle of the pivot member 250, as shown in FIG. 18B. Also good. When the pivot member 250 is fully expanded into a conical shape, the extensible membrane 252 can be formed in a variety of ways, such as an adhesive, so that the pivot member 250 and the membrane 252 form a cone for use as an imaging hood. Through and may be attached to the pivot member 250. The extensible membrane 252 may be made of a porous material such as mesh or PTFE, or a translucent or transparent polymer such as polyurethane, PVC, nylon.

  FIGS. 19A and 19B show yet another variation where the distal portion of the indwelling catheter 16 may be made from a flexible metal or polymeric material to form a radially expandable hood 254. As shown in FIG. 19A, the plurality of slots 256 may be formed in a uniform pattern across the distal portion of the indwelling catheter 16. Slots 256 may be radially utilized by each of the slots 256 that expand into the opening, as shown in FIG. 19B, when the distal portion is strongly urged to open radially using any of the methods described above. It may be formed in a pattern such that an expanded conical hood 254 can be formed. The extensible membrane 258 may lie on the exterior or interior surface of the hood 254 to form a fluid impermeable hood 254 so that the hood 254 can be used as an imaging hood. Alternatively, the extensible membrane 258 may alternatively be formed in each opening 258 to form a fluid impermeable hood 254. When the imaging procedure is complete, the hood 254 may be retracted to its thin structure.

  Still another structure of the imaging hood can be seen in FIGS. 20A and 20B, in which case the imaging hood may be formed from a plurality of overlapping hood members 260 lying on top of each other in an overlapping pattern. When expanded, each of the hood members 260 may extend radially outward with respect to the indwelling catheter 16 to form a conical imaging hood, as shown in FIG. 20B. Adjacent hood members 260 may overlap each other along overlapping joints 262 to form a fluid retaining surface within the imaging hood. Further, the hood member 260 may be made of any number of biocompatible materials, such as nitinol, stainless steel, polymers, etc., that are sufficiently strong and optionally retract the surrounding tissue from the tissue region of interest.

  Although it is generally desirable to have the imaging hood contact the tissue surface in a normal orientation, the imaging hood may alternatively be configured to contact the tissue surface at an acute angle. An imaging hood configured for such contact with tissue may also be particularly suitable for contact with tissue surfaces that have unpredictable or uneven anatomical topography. For example, as shown in the variation of FIG. 21A, the indwelling catheter 270 may have an imaging hood 272 that is configured to be particularly flexible. In this variation, the imaging hood 272 may consist of one or more sections 274 that are configured to fold or disassemble, for example, by utilizing a pleated surface. Thus, as shown in FIG. 21B, when the imaging hood 272 is brought into contact with a non-uniform tissue surface T, the section 274 can closely fit the tissue. These sections 274 are, for example, by utilizing an accordion-type configuration to allow adaptation with trabeculae in the heart or non-uniform anatomy found inside various body lumens. It may be individually foldable.

  In yet another alternative, FIG. 22A shows yet another variation in which an imaging hood 282 is attached to an indwelling catheter 280. FIG. The contact lips or edges 284 may comprise one or more electrical contacts 286 that are positioned circumferentially around the contact edges 284. Electrical contact 286 may be configured to contact tissue and positively indicate whether tissue contact has been achieved, for example, by measuring a differential impedance between blood and tissue. Alternatively, the processor, eg, the processor 98 in electrical communication with the contact 286, may be configured to determine what type of tissue is in contact with the electrical contact 286. In yet another alternative, processor 98 may be generated in underlying tissue, such as the accessory pathway, for the purpose of electrically mapping the heart tissue and later treating arrhythmias that may be detected, as described below. It may be configured to measure electrical activity.

  Another variation of ensuring contact between imaging hood 282 and underlying tissue can be seen in FIG. 22B. This variation may have an inflatable contact edge 288 around the circumference of the imaging hood 282. If the imaging hood 282 is placed against a tissue surface that is uneven or has various anatomy, the inflatable contact edge 288 may be inflated with fluid or gas through the inflation lumen 289. The expanded circumferential surface 288 may be adapted to the tissue surface and provide continuous contact across the hood edge by facilitating retention of the imaging fluid within the hood 282.

  In addition to the imaging hood, various instruments may be used with the imaging and operating system. For example, after the opaque blood is removed from the area within the imaging hood 12 and the underlying tissue is visualized through a clean fluid, the blood may re-infiltrate into the imaging hood 12 and obstruct visibility. One method for automatically maintaining an obstruction-free imaging area is a transducer, for example, an ultrasound transducer positioned at the distal end of an indwelling catheter within the imaging hood 12, as shown in FIG. 290 may be used. The transducer 290 transmits an energy pulse 292 into the imaging hood 12 and waits to detect backscattered energy 294 reflected from debris or blood in the imaging hood 12. If backscatter energy is detected, the pump may be automatically activated to dispense additional fluid into the imaging hood until no debris or blood is detected.

  Alternatively, as shown in FIG. 24A, one or more sensors 300 may be positioned on the imaging hood 12 itself to detect a number of different parameters. For example, the sensor 300 may be configured to detect the presence of oxygen in the surrounding blood, the pressure of the blood and / or imaging fluid, the color of the fluid in the imaging hood, and the like. The fluid color may be particularly useful for detecting the presence of blood in the imaging hood 12 by utilizing a reflective sensor to detect back reflections from the blood. Any reflected light from blood that may be present in the imaging hood 12 may be optically or electrically transmitted through the indwelling catheter 16 to a red filter in the control electronics 118. Any red color that may be detected indicates the presence of blood, triggers a signal to the physician, or automatically activates the pump and dispenses additional fluid into the imaging hood 12 for blood May be removed.

  An alternative method for detecting the presence of blood in the hood 12 may include detecting transmitted light through the imaging fluid in the imaging hood 12. For example, if a white light source utilizing an LED or optical fiber is illuminated inside the imaging hood 12, the presence of blood may cause red to penetrate the fluid. The degree or intensity of red color detected may correspond to the amount of blood present in the imaging hood 12. The red sensor, in one variation, can simply comprise a phototransistor, above which there is a red transmission filter that can ascertain how much red light has been detected, The presence of blood in the imaging hood 12 can then be shown. When blood is detected, the system may pump additional cleaning fluid to allow closed loop feedback control of the pressure and flow level of the cleaning fluid.

  Any number of sensors may be positioned along the exterior 302 of the imaging hood 12 or within the interior 304 of the imaging hood 12 and may detect parameters within the imaging hood 12 as well as the exterior of the imaging hood 12. . A structure such as that shown in FIG. 24B may be particularly useful for automatically maintaining an imaging area free of obstacles based on physical parameters such as blood pressure, as described above for FIGS. 10A and 10B. Good.

  In addition to sensors, one or more light emitting diodes (LEDs) may be utilized to provide illumination within the imaging hood 12. Although illumination may be provided by an optical fiber that is passed through the indwelling catheter 16, the use of LEDs across the imaging hood 12 may eliminate the need for additional optical fibers to provide illumination. Wires connected to one or more LEDs may be passed through or over the hood 12 and along the external surface or may be extruded within the indwelling catheter 16. The one or more LEDs are positioned in a circumferential pattern 306 around the imaging hood 12 as shown in FIG. 25A or in a linear longitudinal pattern 308 along the imaging hood 12 as shown in FIG. 25B. May be. Other patterns such as a spiral or spiral pattern may also be utilized. Alternatively, the LED may be positioned along a support member that forms part of the imaging hood 12.

  Another alternative to illumination within the imaging hood 12 may utilize a separate lighting tool 310, as shown in FIG. 26A. An example of such a tool may comprise a flexible intravascular delivery member 312 having a conveying member 314 pivotally connected 316 to the distal end of the delivery member 312. One or more LEDs 318 may be mounted along the transport member 314. In use, the delivery member 312 may be advanced through the indwelling catheter 16 until the carrier member 314 is positioned within the imaging hood 12. Upon entering the imaging hood 12, the transport member 314 may be pivoted in any number of directions to facilitate or optimize illumination within the imaging hood 12, as shown in FIG. 26B.

  When utilizing LEDs for illumination, the LEDs may comprise a single LED color, eg, white light, whether positioned along the imaging hood 12 or along a separate instrument. Alternatively, other colors such as red, blue, yellow, etc. LEDs may be utilized exclusively or in combination with white LEDs to provide various illuminations of the tissue or fluid being imaged. Good. Alternatively, an infrared or ultraviolet light source may be employed to allow imaging under the tissue surface or to cause tissue fluorescence emission for use in system guidance, diagnosis, or treatment.

  In addition to providing a visualization platform, the imaging assembly may also be utilized to provide a treatment platform for treating the tissue being visualized. As shown in FIG. 27, the indwelling catheter 320 may include an imaging hood 322 as described above, and a fluid delivery lumen 324 and an imaging lumen 326. In this variation, a treatment tool, such as needle 328, is delivered through fluid delivery lumen 324 or in another working lumen and advanced through open area 332 to treat the visualized tissue. Also good. In this case, the needle 328 may define one or several ports 330 for delivering medication through the interior. Thus, once the appropriate area of tissue has been imaged and located, the needle 328 may be advanced and penetrated into the underlying tissue where the therapeutic agent may be delivered through the port 330. . Alternatively, the needle 328 may be in electrical communication with a power source 334, eg, radio frequency, microwave, etc., to cauterize the underlying tissue region of interest.

  FIG. 28 illustrates another alternative where the indwelling catheter 340 may have an imaging hood 342 attached thereto as described above, but the treatment tool 344 is a structure of a helical tissue penetrating device 344. Show. For use in stabilizing the imaging hood against the underlying tissue, as shown and described in FIGS. 7A and 7B, the helical tissue penetrating device 344 also manipulates the tissue for various therapeutic procedures. May be used for this purpose. The helical portion 346 may also define one or several ports for delivery of the therapeutic agent therethrough.

  In yet another alternative, FIG. 29 shows an indwelling catheter 350 having an expandable imaging balloon 352, eg, filled with saline 356. The treatment tool 344 may be translatable relative to the balloon 352 as described above. To prevent the tool penetration 346 from tearing the balloon 352, a stop 354 may be formed on the balloon 352 to prevent the portion 346 from passing proximally past the stop 354.

  An alternative structure for a tool that may be delivered through the indwelling catheter 16 for use in tissue manipulation within the imaging hood 12 is shown in FIGS. 30A and 30B. FIG. 30A shows one variation of a horned instrument 360, such as a tissue grasper, which may be configured with an elongate shaft for intravascular delivery through an indwelling catheter 16, When placed in 12, the distal end may be angled with respect to its elongated shaft. The elongate shaft may be configured to automatically angle itself when actuated, for example, by an elongate shaft made at least partly of a shape memory alloy, or by pulling a pull wire, for example. Good. FIG. 30B shows another structure for the instrument 362 that is configured to reconfigure its distal portion within the imaging hood 12 to an off-axis structure. In any case, the instruments 360, 362 may be reconfigured to a thin shape when retracted proximally into the indwelling catheter 16.

  Other instruments or tools that may be utilized with the imaging system are shown in the side and end views of FIGS. 31A-31C. FIG. 31A shows a probe 370 having a distal tip 372 that may be reconfigured from a low profile to a curved profile. The tip 372 may be configured as an ablation probe that utilizes radio frequency energy, microwave energy, ultrasonic energy, laser energy, or even cryoablation. Alternatively, the tip 372 may have a number of electrodes thereon for detecting or mapping electrical signals transmitted through the underlying tissue.

  In the case of a tip 372 utilized for ablation of the underlying tissue, an additional temperature sensor such as a thermocouple or thermistor 374 positioned on the elongate member 376 is contacted distally to monitor the temperature of the ablated tissue. It may be advanced into the imaging hood 12 adjacent to the tip 372. FIG. 31B shows an example in an end view of one structure relative to a distal tip 372 that may simply be angled to a vertical structure to contact tissue. FIG. 31C shows another example where the tip may be reconfigured into a curved tip 378 for increased tissue contact.

  32A and 32B show another variation of an ablation tool utilized with an imaging hood 12 having a sealed bottom. In this variation, an ablation probe, such as a cryoablation probe 380 having a distal tip 382, is such that the tip 382 is located distal to the transparent membrane or blockage 384, as shown in the end view of FIG. 32B. Alternatively, it may be positioned through the imaging hood 12. The shaft of probe 380 may pass through opening 386 defined through membrane 384. In use, clean fluid may be pumped into the imaging hood 12 as described above, and the distal tip 382 may be placed against the tissue region to be ablated, and the imaging hood 12 and membrane 384 are positioned on or adjacent to the ablated tissue. In the case of cryoablation, the imaging fluid may be warmed prior to dispensing into the imaging hood 12 so that the tissue contacted by the membrane 384 can be warmed during the cryoablation procedure. For example, in the case of thermal ablation utilizing radio frequency energy, fluid that is contacted by the membrane 384 during the ablation procedure and dispensed into the imaging hood 12 so that the tissue adjacent to the ablation probe is similarly cooled. May be cooled.

  In any of the above examples, the imaging fluid may vary its temperature to facilitate various procedures performed on the tissue. In other cases, the imaging fluid itself may be changed to facilitate various procedures. For example, as shown in FIG. 33A, the indwelling catheter 16 and imaging hood 12 are advanced toward a lesion or tumor 392 on the bladder wall in a hollow human organ such as the bladder filled with urine 394. Also good. The imaging hood 12 may be placed over the entire lesion 392 or over a portion of the lesion. When secured to the tissue wall 390, frozen fluid, ie, fluid cooled to below the freezing temperature of water or blood, for example, is shown in FIG. 33B while avoiding the formation of ice on the surface of the instrument or tissue. As described above, the lesion 390 may be frozen and cauterized by being pumped into the imaging hood 12.

As the frozen fluid exits the imaging hood 12 and leaks into the organ, the fluid may be naturally warmed by the patient's body and eventually removed. The frozen fluid may be a colorless and translucent fluid that allows visualization of the underlying tissue therethrough. An example of such a fluid is Fluorinert ^™ (3M, St. Paul, MN), a colorless and odorless perfluoro liquid. The use of a liquid such as Fluorinert ^™ allows a cryoablation procedure without the formation of ice inside or outside the imaging hood 12.
Alternatively, rather than using cryoablation, thermotherapy may also be achieved by heating the Fluorinert ^™ liquid to an elevated temperature to cauterize the lesion 392 in the imaging hood 12. In addition, Fluorinert ^™ may be utilized in various other parts of the body, such as within the heart.

  FIG. 34A shows another variation of an instrument that may be utilized with an imaging system. In this variation, the laser ring generator 400 may be passed through the indwelling catheter 16 and partially into the imaging hood 12. The laser ring generator 400 is typically used to generate an annulus of laser energy 402 for generating a conduction block around the pulmonary vein, typically in the treatment of atrial fibrillation. An annulus of laser energy 402 may be generated such that the diameter of the ring 402 is contained within the diameter of the imaging hood 12 and allows tissue ablation directly over the tissue being imaged. The signal that causes atrial fibrillation typically originates from the entry region of the pulmonary vein into the left atrium, and treatment may occasionally include delivering ablation energy to the pulmonary vein opening in the atrium. The ablated area of tissue may create an annular scar that inhibits the impact of atrial fibrillation.

  When using laser energy to cauterize heart tissue, it may generally be desirable to maintain the integrity and health of the tissue above the surface while cauterizing the underlying tissue. This may be accomplished, for example, by cooling the imaging fluid to a temperature below the patient's body temperature but above the blood freezing point (eg, 2 ° C. to 35 ° C.). Thus, the cooled imaging fluid may maintain the surface tissue at the cooled fluid temperature, while the deeper underlying tissue remains at the patient's body temperature. When laser energy (or other types of energy such as radio frequency energy, microwave energy, ultrasonic energy, etc.) irradiates the tissue, both the cooled tissue surface as well as the deeper underlying tissue raise the temperature uniformly. The deeper underlying tissue maintained at body temperature is sufficiently high and rises to a temperature that destroys the underlying tissue. On the other hand, the temperature of the cooled surface tissue also rises, but only near or slightly above body temperature.

  Accordingly, as shown in FIG. 34B, an example of treatment may include passing an indwelling catheter 16 across the atrial septum AS and into the left atrium LA of the patient's heart H. Other methods of accessing the left atrium LA may also be utilized. The imaging hood 12 and the laser ring generator 400 may be positioned adjacent to or over one or more of the pulmonary vein PV inlets OT, and A conductive block may be created by cauterizing the tissue around the entrance OT with a ring. Once one or more of the tissue surrounding the entrance OT has been cauterized, the imaging hood 12 may be reconfigured to be thin for removal from the patient's heart H.

  One difficulty in treating tissue in or around the inlet OT is the dynamic fluid flow of blood through the inlet OT. The kinetic action makes it difficult to cannulate or enter the inlet OT. Thus, another variation of an instrument or tool that can be utilized with an imaging system is an extendable cannula 410 having a cannula lumen 412 defined therethrough, as shown in FIG. 35A. The extendable cannula 410 may generally be positioned within the indwelling catheter 16 during delivery and then projected distally through the imaging hood 12 and optionally beyond, as shown in FIG. 35B. An elongated tubular member may be provided.

  In use, when the imaging hood 12 is desirably positioned relative to the tissue, for example, outside the pulmonary vein PV inlet OT, as shown in FIG. 35C, the extendable cannula 410 is as described above. Optionally, the tissue may be projected distally from the indwelling catheter 16 while imaging tissue through the imaging hood 12. The extendable cannula 410 may protrude distally until its distal end extends at least partially into the inlet portion OT. Upon entering the entrance OT, the instrument or energy ablation device may be extended through and out of the cannula lumen 412 for treatment within the entrance OT. Upon completion of the procedure, the cannula 410 may be retracted proximally and removed from the patient's body. The extendable cannula 410 may also include an inflatable occlusion balloon at or near its distal end to block blood flow out of the PV and maintain a clear view of the tissue region. Alternatively, the extendable cannula 410 defines a lumen through the interior beyond the occlusion balloon, and normally guides the blood through the cannula 410 out of the proximal of the imaging hood, thereby normally leaving the pulmonary vein PV. At least a portion of the exiting blood may be bypassed.

  Yet another variation of the use of tools or instruments can be seen in the side and end views of FIGS. 36A and 36B. In this variation, the imaging hood 12 may have one or more tubular support members 420 that are integral with the hood 12. Each of the tubular support members 420 may define an access lumen 422 through which one or more instruments or tools may be delivered for treatment on the underlying tissue. One particular example is shown and described with respect to FIG. 7C.

  Various methods and instruments may be utilized to use or facilitate use of the system. For example, one method may include facilitating initial delivery and placement of the device into the patient's heart. A separate guide probe 430 may be utilized, as shown in FIGS. 37A and 37B, when initially guiding the imaging assembly within the heart chamber, eg, to the mitral valve MV. The guide probe 430 may comprise an optical fiber that may use a light source 434 to illuminate the distal tip portion 432 through the interior, for example. The tip portion 432 may be advanced into the heart, for example through the coronary sinus CS, until the tip is positioned adjacent to the mitral valve MV. The tip 432 may be illuminated as shown in FIG. 37A, and the imaging assembly 10 may then be directed toward the illuminated tip 432 visible from within the atrium toward the mitral valve MV.

  In addition to the devices and methods described above, an imaging system may be utilized to facilitate various other procedures. Referring now to FIGS. 38A and 38B, the imaging hood of the device may be specifically utilized. In this example, the foldable membrane or disk-shaped member 440 may be temporarily fixed around the contact edge of the imaging hood 12 or around the lips. During intravascular delivery, the imaging hood 12 and attached member 440 are both disassembled structures and may remain thin for delivery. At the time of placement, both the imaging hood 12 and the member 440 may extend into the expanded structure.

  The disc-shaped member 440 may be made of various materials depending on applications. For example, the member 440 may be made of a porous polymeric material infused with a drug eluting formulation 442 for implantation into the tissue surface for slow infusion of the drug into the underlying tissue. Alternatively, member 440 may be made from a nonporous material, such as a metal or polymer, for implantation and closure over a wound or cavity to prevent fluid leakage. In yet another alternative, the member 440 may be made of an inflatable material that is secured to the expanded imaging hood 12. The expanded member 440 may be released from the imaging hood 12 when implanted or secured to a tissue surface or wound. Upon release, the expanded member 440 may contract to a smaller size while approaching the attached underlying tissue, eg, closing the wound or opening.

  One method for securing the disk-shaped member 440 to the tissue surface may include a plurality of tissue anchors 444 attached to the surface of the member 440, such as barbs, hooks, protrusions, and the like. Other methods of attachment may include adhesives, stitching and the like. In use, as shown in FIGS. 39A-39C, the imaging hood 12 may be deployed in an expanded configuration, and the member 440 attached thereto includes a plurality of tissue anchors 444 projecting distally. . Tissue anchor 444 is treated tissue region 446 as shown in FIG. 39A until anchor 444 is secured in the tissue and member 440 is positioned directly relative to the tissue, as shown in FIG. 39B. You may be strongly pushed into the. The pull wire may be actuated to release the member 440 from the imaging hood 12, and the indwelling catheter 16 may be retracted proximally, leaving the member 440 fixed with respect to the tissue 446.

  Another variation of tissue manipulation and treatment can be seen in the variation of FIG. 40A illustrating the imaging hood 12 having an indwellable anchor assembly 450 attached to the tissue contacting edge 22. FIG. 40B illustrates the anchor assembly 450 removed from the imaging hood 12 for clarity. The anchor assembly 450 may be viewed as having a plurality of discontinuous tissue anchors 456, such as barbs, hooks, protrusions, etc., each having a suture holding end at the proximal end of the anchor 456, for example, There is a small hole or opening 458. The suture member or wire 452 passes through the opening 458 and through the band element 454, which may be configured to slide in a fixed direction on the suture or wire 452 and bring each of the anchors 456 closer together. Each anchoring device 456 may be slidably connected. Each of the anchors 456 may be temporarily attached to the imaging hood 12 through various methods. For example, a pull or retainer wire may hold each of the anchors in a receiving ring around the circumference of the imaging hood 12. When the anchor 456 is released, the pull or retainer wire may be pulled from its proximal end outside the patient's body, thereby releasing the anchor 456 from the imaging hood 12.

  An example of the use of the anchor assembly 450 for closing an opening or wound 460, eg, patent foramen ovale (PFO) is shown in FIGS. 41A-41D. Indwelling catheter 16 and imaging hood 12 may be delivered transvascularly, for example, into the patient's heart. When the imaging hood 12 is placed in its expanded structure, the imaging hood 12 may be positioned adjacent to the opening or wound 460, as shown in FIG. 41A. With the anchor assembly 450 positioned on the expanded imaging hood 12, the indwelling catheter 16 causes the contact edge of the imaging hood 12 and the anchor assembly 450 to move within the region surrounding the tissue opening 460, as shown in FIG. 41B. It may be directed to push forward strongly. Once the anchor assembly 450 is secured within the surrounding tissue, the anchor may be released from the imaging hood 12, leaving the anchor assembly 450 and the suture member 452 swaying from the anchor as shown in FIG. 41C. The suture or wire member 452 is pulled proximally from the outside of the patient as shown in FIG. 41D and closes the tissue opening 462 by approaching the anchors of the anchor assembly 450 toward each other in a purse-string manner. Tighten tightly. The band element 454 may also be pushed distally over the suture or wire member 452 to prevent the proximal anchor assembly 450 from loosening or spreading.

  Another example of an alternative use in which the indwelling catheter 16 and the indwelling imaging hood 12 may be positioned within the patient's body to draw blood 472 into the indwelling catheter 16 is shown in FIG. To filter the drawn blood 472, the drawn blood 472 may be pumped through a dialysis unit 470 located outside the patient's body, and the filtered blood is reintroduced back into the patient's body. May be.

  FIG. 43A shows a variation of the indwelling catheter 480 having yet another variation, a first indwellable hood 482 and a second indwellable hood 484 positioned distal to the first hood 482. Shown in 43B. The indwelling catheter 480 may also have a side-view imaging element 486 positioned between the first and second hoods 482, 484 along the length of the indwelling catheter 480. In use, such a device may be introduced through the lumen 488 of the blood vessel VS, in which case one or both hoods 482, 484 are expanded to gently touch the peripheral wall of the blood vessel VS. Also good. When the hoods 482, 484 are expanded, clean imaging fluid is pumped in the space defined between the hoods 482, 484, replacing any blood, as shown in FIG. 490 may be created. An imaging element 486 may be used to observe the surrounding tissue surface contained between the hoods 482, 484 with a cleaning fluid intermediate the hoods 482, 484. In addition, other instruments or tools may be passed through the indwelling catheter 480 and through one or more openings defined along the catheter 480 to perform a treatment procedure on the vessel wall.

  Another variation of an indwelling catheter 500 that may be used to image tissue on the side of the instrument can be seen in FIGS. 44A-45B. 44A and 44B show a side view and an end view of an indwelling catheter 500 having a side imaging balloon 502 with a thin structure that is not inflated. Side imaging element 504 may be positioned within the distal portion of catheter 500 where balloon 502 is disposed. Balloon 502 may expand radially and contact surrounding tissue when inflated, but is shown in the side, top, and end views of FIGS. 45A-45B, respectively, when imaging element 504 is located. As such, the visualization zone 506 may be created by the balloon 502. The visualization zone 506 is simply a cavity or channel defined within the inflated balloon 502 so that the visualization element 504 is provided with an image of a region in the area 506 that is unobstructed and not obstructed by the balloon 502. It may be.

  In use, the indwelling catheter 500 may be advanced transvascularly through the vessel lumen 488 toward the lesion or tumor 508 to be visualized and / or treated. Upon reaching the lesion 508, the indwelling catheter 500 may be positioned adjacent to the lesion 508 and the balloon 502 may be inflated so that the lesion 508 is contained within the visualization zone 506. When the balloon 502 is fully inflated and contacts the vessel wall, clean fluid is pumped through the indwelling catheter 500 and into the visualization zone 506 as shown in the side and end views of FIGS. 46A and 46B, respectively. To replace any blood or opaque fluid from the area 506. The lesion 508 may then be visually inspected and treated by passing any number of instruments through the indwelling catheter 500 and into the area 506.

  In additional variations of the imaging hood and indwelling catheter, the various assemblies may be configured to treat symptoms such as atrial fibrillation, particularly while directly under visualization. In particular, the device and assembly may be configured to facilitate the application of energy to the underlying tissue in a controlled manner while directly visualizing the tissue to monitor and confirm proper treatment. In general, as shown in FIGS. 47A to 47O, the imaging and manipulation assembly is for the patient's heart H through the inferior vena cava IVC and into the right atrium RA, for example, as shown in FIGS. It may be advanced transvascularly into. Within the right atrium RA (or prior to entry), the hood 12 may be placed and positioned with respect to the atrial septum AS, and the hood 12 removes blood from the inside to remove underlying tissue as described above. Saline may be infused to observe the surface. The hood 12 may be further manipulated or articulated into a desired location along the tissue wall, eg, over the foveal FO, to puncture the left atrium LA, as shown in FIG. 47C. .

  Once the hood 12 is desirably positioned over the foveal FO, a penetrating instrument 510, eg, a hollow needle, is advanced through the hood 12 from the catheter 16 to access the left atrium LA, as shown in FIG. 47D. You may penetrate the atrial septum AS. The guidewire 17 may then be advanced through the penetrating instrument 510 and introduced into the left atrium LA, where it is further advanced into one of the pulmonary veins PV, as shown in FIG. 47E. May be. As the guidewire 17 crosses the atrial septum AS into the left atrium LA, the penetrating instrument 510 may be withdrawn, or the hood 12 is further contracted to its thin structure, as shown in FIG. 47F. The catheter 16 and sheath 14 may optionally be withdrawn as well, while leaving the guide wire 17 in place across the atrial septum AS, as shown in FIG. 47G.

  While an example is shown for traversing through a septum while under direct visualization, alternative methods and devices for transseptal access are incorporated herein by reference in their entirety. This is shown and described in further detail in co-owned US patent application Ser. No. 11 / 763,399, filed Jun. 14, 2007. Such transseptal access methods and devices may be fully utilized with the methods and devices described herein, as practicable.

  If the sheath 14 is left in place within the inferior vena cava IVC, the optional dilator 512 may be advanced through the sheath 14 and along the guide wire 17 as shown in FIG. 47H. In that case, as shown in FIG. 47I, the transseptal puncture is expanded through the atrial septum AS, allowing other instruments to be advanced transseptally into the left atrium LA. Also good. When the transseptal opening is expanded, its thin hood 12 and catheter 16 are re-introduced through the sheath 16 over the guidewire 17 and into the left atrium LA, as shown in FIG. 47J. It may be advanced a distance. Optionally, the guide wire 17 may be withdrawn before or after introduction of the hood 12 into the left atrium LA. As shown in FIG. 47K, when the hood 12 is advanced into the left atrium LA and expanded inward, the indwelling catheter 16 and / or hood 12 is articulated as shown in FIG. 47L. It may be brought into contact with or cover the entrance of the pulmonary vein PV. Once the hood 12 is desirably positioned along the tissue surrounding the pulmonary vein, the tissue may be cauterized, as shown by the circumferentially cauterized tissue 514 around the pulmonary vein inlet shown in FIG. 47M. As such, the open area in the hood 12 may have blood removed with a translucent or transparent fluid to directly visualize the underlying tissue. One or more of the inlets may be cauterized either partially or completely around the opening, as shown in FIGS. 47N and 47O, respectively, to create a conductive block.

  Since the hood 12 allows direct visualization of the underlying tissue in vivo, the hood 12 visually confirms that the appropriate area of the tissue has been cauterized and / or that the tissue has been adequately cauterized. May be used to Visual monitoring and confirmation may be accomplished in real time during the procedure or after the procedure is complete. In addition, the hood 12 may be utilized to post-operatively image tissue that has been cauterized in previous procedures to determine if proper tissue ablation has been achieved. In the partial cross-sectional views of FIGS. 48A and 48B, the hood 12 is shown advanced into the left atrium LA to examine a discontinuous lesion 520 created around the entrance of the venous PV. If desired or determined to be necessary, untreated tissue may be further cauterized using the hood 12 under direct visualization.

  A number of different ablation instruments may be utilized to cauterize the tissue visualized in the hood 12. In particular, as shown in the perspective view of FIG. 49A, an ablation probe 534 having at least one ablation electrode 536 utilizing, for example, radio frequency (RF), microwave, ultrasound, laser, cryoablation, etc. It may be advanced through the catheter 16 and into the open area 26 of the hood 12. The hood 12 also includes a number of support posts 530 that extend longitudinally along the hood 12 to provide structural support and provide a platform on which the imaging element 532 may be positioned. Is shown. As described above, the imaging element 532 may comprise a number of imaging devices such as optical fibers or electronic imaging devices such as CCD or CMOS imaging elements. In any case, the imaging element 532 is positioned along the support post 530 off-axis relative to the longitudinal axis of the catheter 16 such that the element 532 forms an angle to provide a view of the underlying tissue and the ablation probe 536. May be. Further, the probe 536 is positioned off-axis relative to the longitudinal axis of the catheter 16 to allow the probe 546 to reach over the region of tissue that is visualized within the open area 26 and depending on the desired treatment Thus, the distal portion of the ablation probe 536 may be angled or configured to be articulatable to allow for various lesion patterns.

  49B and 49C show side and perspective views, respectively, of the hood 12 positioned relative to the tissue region T to be treated, with translucent or transparent replacement fluid 538 injected into the open region 26 of the hood 12, Replace the blood in it. While under direct visualization from the imaging element 532, the blood may be replaced with a clean fluid, allowing examination of the tissue T, so that the ablation probe 536 is activated and / or optionally angled. And may contact the underlying tissue for treatment.

  FIG. 50A illustrates an ablation probe in which the distal tip 542 of the probe 540 may be angled along the pivot hinge 544 from a vertical thin structure to a right-angle linear electrode to provide a linear transmural lesion. The change type perspective view is shown. Probe 540 is configured similarly to the variation shown in FIGS. 31A and 31B above. Using this structure, rather than a single point of tissue being cauterized, the entire outline of the tissue can be cauterized simultaneously. FIG. 50B shows another variation where the ablation probe 546 may be configured with an annular ablation tip 548 surrounding the opening of the hood 12. This particular variant is also configured similarly to the variant shown above in FIG. 31C. The diameter of the probe 548 can vary, and other annular or elliptical structures, as well as partial annular structures, can be utilized to provide ablation of the entire annular tissue.

  While the tissue is cauterized, it is possible to control the flow of saline from the hood 12 such that saline is injected over the heated electrode after the ablation process each time the electrode is cooled. This is a safety measure that may optionally be implemented to prevent the heating electrode from inadvertently causing unwanted cauterization to other areas of the tissue.

  In yet another variation of cauterizing the underlying tissue while under direct visualization, FIG. 51A shows an embodiment of the hood 12 having an expandable distal membrane 550 that covers the open area of the hood 12. An annular RF electrode tip 552 having electrodes 554 spaced between insulating sections 556 is circumferentially coated around the expandable distal membrane 550, for example, by chemical vapor deposition or any other suitable process. It may be arranged. Electrode tip 552 may be activated by an external power source that is in electrical communication with wire 558. Further, the electrode tip 552 may be retractable into the working channel of the indwelling catheter 16. The imaging element 532 may be attached to a support post of the hood 12 and provide visualization during the ablation process for viewing through clean fluid injected into the hood 12 as described above. FIG. 51B shows a similar variation where an inflatable balloon 560 is utilized and the hood 12 is omitted completely. In this case, the electrode tip 552 may be arranged circumferentially over the balloon distal end in a similar manner.

  In either variant, the hood 12 may be inflated and infused with saline to widen the membrane 550 or directly into the balloon 560 to produce an annular transmural lesion, thus being activated. Pressure may be applied to the contacted target tissue, such as the lung entry region, by a tip 552 that may carry energy to the ablated tissue for lesion formation. The amount of power delivered to each electrode tip 552 can be varied and controlled so that the operator can cauterize areas that may have different thicknesses in different parts of the tissue, Thus, different power is required to generate the lesion.

  FIG. 52 is another variation perspective view having an annular electrode tip 570 with electrodes 572 spaced between the insulating sections 574 and circumferentially disposed around the contact lips or edges of the hood 12. FIG. This variation is similar to the structure shown above in FIG. 22A. Although described above for electrode mapping of underlying tissue, the electrode tip 570 in this variation may be utilized to contact the tissue and to generate an annular lesion around the target tissue.

  When using the imaging hood 12 in any one of the procedures described in this application, the hood 12 has an open area that is uncovered and free of obstacles, as described above, and the hood interior and underlying tissue. Any number of treatments on the tissue may be achieved by providing direct tissue contact with the tissue. However, in an additional variation, the imaging hood 12 may utilize other structures as described above. Additional variations of the imaging hood 12 are shown in the perspective and side views of FIGS. 53A and 53B, respectively, where the imaging hood 12 includes at least one layer of a transparent elastic membrane 580 that covers the distal opening of the hood 12. . Since the opening 582 having a diameter smaller than the diameter of the outer lip of the imaging hood 12 may be defined over the center of the membrane 580 where the longitudinal axis of the hood intersects the membrane, the interior of the hood 12 is opened, It remains in fluid communication with the environment outside the hood 12. Moreover, the opening 582 may be sized, for example, between 1 and 2 mm in diameter and the membrane 580 may be made from any number of transparent elastomers such as silicone, polyurethane, latex, and the like. The contacted tissue may also be visualized through the membrane 580 as well as through the opening 582.

  When the interior of the hood 12 is infused with clean fluid through which the underlying tissue region may be visualized, the opening 582 generally acts as a restrictive passage to reduce the flow rate of fluid outflow from the hood 12. May be. In addition to restricting clean fluid out of the hood 12, the opening 582 may also limit external ambient fluid from entering the hood 12 too quickly. Because the hood 12 may be more easily filled with clear liquid rather than filled with opaque blood that may interfere with direct visualization by the visualization device, fluid outflow from the hood and into the hood Restricting the flow rate of blood inflow may improve visualization conditions.

  Further, the opening 582 is not restrained or restricted by any instrument (eg, penetrating instrument, guidewire, tissue engager, etc.) that is advanced into the interior of the hood for treatment through the opening 582. It may be aligned with the catheter 16 to allow direct access to the underlying tissue. In other variations where the opening 582 may not be aligned with the catheter 16, an instrument that is passed through the catheter 16 may still access the underlying tissue by simply penetrating the membrane 580.

  FIG. 54A shows another variation in which a single RF ablation probe 590 may be inserted into the working channel of a tissue visualization catheter in its closed configuration, where the first half 592 and the second half 594 are: Closed against each other. When actuated by a puller wire or the like, the first half 592 and the second half 594 open laterally into a “Y” configuration via a hinged pivot 602 and are shown in the perspective view of FIG. 54B. As shown, ablation electrode strips 596 connected to halves 592 and 594, respectively, at attachment points 598 and 600 may be exposed. A tension is generated along the axis of the electrode strip 596 to maintain its linear structure. Linear transmural lesion ablation may then be accomplished by delivering energy from the RF electrode to the contacting target tissue surface while visualized in the hood 12.

  55A and 55B illustrate another variation of a perspective view in which a fiber optic bundle coupled to a laser probe 610, eg, a laser generator, may be inserted through the working channel of a tissue visualization catheter. When activated, laser energy 612 may be carried through probe 610 and applied to underlying tissue T at different angles 612 ′, as shown in FIG. 55C, to form various lesion patterns.

  When treating in vivo tissue around the pulmonary vein inlet OT for atrial fibrillation, the step of occluding the blood flow through the pulmonary vein PV is particularly visible when applying ablation energy to the hood 12 to the tissue. And may promote stabilization. In one variation, when the hood 12 is expanded within the left atrium LA, the guidewire 17 may be advanced into the pulmonary vein PV to be treated. The expandable occlusion balloon 620, either advanced over the guidewire 17 or carried directly on the guide 17, is advanced into the pulmonary vein PV distal to the area of tissue to be treated. It may then be expanded to contact the wall of the pulmonary vein PV, as shown in FIG. When the occlusion balloon 620 is dilated, the blood vessel may be occluded and blood flow may be temporarily prevented from entering the left atrium LA. The hood 12 may then be positioned along or around the inlet OT, and the containment space contained between the hood 12 and the occlusion balloon 620 may be infused with clean fluid 528 to obstruct An objectless visualization region 622 may be generated, in which the inlet OT and surrounding tissue are visualized via the imaging element 532 and any of the ablation instruments described herein as practicable. And may be treated accordingly.

  In addition to the use of an occlusion balloon, articulation and manipulation of the hood 12 in the beating heart with dynamic fluid flow may be further facilitated utilizing a support member. In one variation, one or more grasping support members are passed through the catheter 16 and placed from the hood 12 to allow the hood 12 to be walked or moved along the tissue surface of the ventricle. Good. FIG. 57 shows a perspective view of the hood 12 with a first tissue grasping support member 630 having a first tissue grasper 634 positioned at the distal end of the member 630. The distal portion of the member 630 is angled via a first angled or curved portion 632 to allow the tissue grasper 634 to be more directly approached and attached on the tissue surface. Good. Similarly, the second tissue grasping support member 636 includes the second angled or curved portion 638 and the second tissue grasper 640 positioned at the distal end of the member 638, with the hood 12 attached. It may extend through. In this variation, although shown as a helical tissue engager, other tissue grasping mechanisms may alternatively be utilized.

  As illustrated in FIGS. 58A-58C, when the hood 12 is expanded within the left atrium LA, the first and second tissue graspers 634, 640 are deployed and advanced distally of the hood 12. Also good. The first tissue grasper 634 is advanced into contact with the first tissue region adjacent to the inlet portion OT, as shown in FIG. 58A, and torque is applied until the grasper 634 is engaged with the tissue. It may be applied. Once the grasper 634 is temporarily attached to the tissue, the second tissue grasper 640 is moved and positioned relative to the tissue region adjacent to the first tissue grasper 636, where it is shown in FIG. As such, torque may be applied and temporarily attached to the tissue. When the second grasper 640 is now attached to the tissue, the first grasper 636 may be released from the tissue, and the hood 12 and the first tissue grasper 636 are as shown in FIG. 58C. In addition, the second grasper 640 may first be used as a pivot point to facilitate movement of the hood 12 along the tissue wall to make an angle to another region of tissue. This process may be repeated as many times as desired until the hood 12 is positioned along the tissue region to be treated or examined.

FIG. 59 is extended from the hood 12 because of the steep angle to the pulmonary vein, specifically its proximity and the transseptal point of entry entering the left atrium LA through the atrial septum AS. FIG. 10 shows another view illustrating the first tissue grasper 634 temporarily engaged with tissue adjacent to the right lower pulmonary vein PV _RI , which is generally difficult to access. When the catheter 16 is bent back to direct the hood 12 generally in the direction of the right lower pulmonary vein PV _RI and the first tissue grasper 634 is engaged over the tissue, the hood 12 and the indwelling catheter 16 are 634 may be approached toward the right lower pulmonary vein inlet to examine and / or treat the tissue.

  FIG. 60 illustrates an alternative method for a tissue visualization catheter that accesses the left atrium LA of the heart H to examine and / or treat the area surrounding the pulmonary vein PV. Using an intravascular transfemoral approach, the indwelling catheter 16 is advanced through the aorta AO, through the aortic valve AV into the left ventricle LV, and through the mitral valve MV into the left atrium LA. May be allowed. Upon entering the left ventricle LV, the helical tissue grasper 84 may be extended through the hood 12 to contact the desired tissue region to facilitate examination and / or treatment.

  When utilizing a tissue grasper to pull the hood 12 and catheter 16 toward the tissue region for examination or treatment, sufficient force transmission to articulate and advance the catheter 16 is due to the serpentine structure of the catheter 16. May be suppressed. Thus, the first tissue grasper 634 is attached to one end of the hood 12 and the length of wire or suture 650 passing through the fixed end of the first grasper 634, as shown in FIG. 61A. It can be used to make the ring optional. The suture 650 passed through the catheter 16 is later pulled from its proximal end (as indicated by the direction of tension 652) from the outside of the patient's body so that the catheter 16 is a member 630, like a pulley system. It is possible to provide additional tensile strength to move distally along the length (as shown by hood movement 654 as shown in FIG. 61B). 61C and 61D further illustrate a tensioned suture 650 due to the steep angle structure that the catheter 16 and hood 12 must conform to and the resulting direction of movement 654 of the hood 12 into the inlet OT. The relative movement of is illustrated. Under such a pulley mechanism, the hood 12 may also provide additional pressure on the target tissue to provide a better seal between the hood 12 and the tissue surface.

  In yet another variation of ablation treatment of intra-atrial tissue, FIG. 62A shows the sheath 14 positioned transseptally and a transparent intra-atrial balloon 660 is used for a relatively large portion of the atrium, eg, the left atrium. It is expanded to a size that occupies 75% or more of the volume of LA. Balloon 660 may be inflated with a clean fluid such as saline or gas. Visualization of the tissue surface in contact with the intra-atrial balloon 660 is possible when an opaque body fluid such as blood is replaced by the balloon 660. It may also be possible to visualize and identify the entrance of multiple pulmonary veins PV through balloon 660. Once the location of the pulmonary vein PV is identified, the user may orient the instrument inside the ventricle by using the pulmonary vein PV as an anatomical landmark.

  62B and 62C provide an imaging instrument, such as a fiberscope 662, that is advanced at least partially inside the intra-atrial balloon 660 to examine the ventricle, as well as obtaining further close-up images of the tissue region of interest, as well as extensive The steps of articulating the fiberscope 662 to navigate the movement are illustrated. FIG. 62D illustrates a variation of balloon 660 so that the position and inflation size of balloon 660 can be tracked or monitored by extracorporeal imaging techniques such as fluoroscopy, magnetic resonance imaging, computed tomography, and the like. In addition, one or more radiopaque fiducial markers 664 may be positioned over the balloon.

  When the balloon 660 is inflated and pressed against the atrial tissue wall to access and treat the tissue region of interest within the ventricle, the needle catheter 666 with the penetrating ablation tip 668 passes through the lumen of the indwelling catheter, It may be advanced into the balloon 660. Needle catheter 666 may be articulated to direct ablation tip 668 to the tissue to be treated, and ablation tip 668 is simply advanced to penetrate through balloon 660 into the underlying tissue. There, an ablation treatment may be achieved, as shown in FIG. If the needle protruding from the ablation tip 668 is of a sufficiently small diameter size and is gently inserted through the balloon 660, leakage or rupture of the balloon 660 can be avoided. Alternatively, the balloon 660 may be made from a porous material so that the circuit between the anode and cathode is closed through the balloon wall by allowing the diffused saline to become an intermediate conductor. By allowing the infused clean fluid, such as saline, to diffuse out of the balloon 660 and provide a medium for RF tissue ablation. Other ablation instruments such as laser probes can also be utilized to access the tissue region to be treated by insertion from within balloon 660.

  64A and 64B illustrate a detailed view of the safety function, and one or more ablation probes 672 can be deployed from the retracted structure, as shown in FIG. 64A, and each probe is Hidden in each opening 670. This prevents unintentional penetration of the balloon 660 or inadvertent ablation of the surrounding tissue around the treatment area. When the tissue is treated, one or more probes 672 may protrude from their respective openings 670, as shown in FIG. 64B. Ablation probe 672 may be configured as a monopolar electrode assembly. FIG. 64C illustrates a perspective view of an ablation catheter 666 configured as a bipolar probe that includes a return electrode 674. The return electrode 674 may be positioned along the shaft 666, for example, approximately 10 mm proximal to the probe 672.

  In yet another variation, FIG. 65A shows a stabilizing sheath 14 that may be advanced through the inferior vena cava IVC as described above in a flexible state. Once the sheath 14 is desirably positioned within the right atrium RA, the structure may optionally be locked or secured so that its shape is independent of the instrument that may be advanced therethrough. Or may be held independently of heart movement. Such a locking structure may be utilized via any number of mechanisms as is well known in the art.

  In any event, the sheath 14 may have a stabilizing balloon 680 similar to that described above, which is expanded within the right atrium RA so that the balloon 680 is ventricular wall as shown in FIG. 65B. Until the sheath 14 provides stability to the sheath 14. The tip of the sheath 14 is any of the methods and / or devices described above in greater detail in US patent application Ser. No. 11 / 763,399, filed Jun. 14, 2007, incorporated above. This may be used to advance further to perform a transseptal procedure to the left atrium LA.

  When the sheath 14 is introduced transseptally into the left atrium LA, as shown in FIG. 65C, the articulatable section 682 is optional, as indicated by the direction of connection 684, such as by a pull wire. May be directed toward the area of tissue to be treated, such as the pulmonary vein inlet. When the steerable section 682 is desirably directed towards the tissue to be treated, the amount of force transmission and steering of the tissue visualization catheter toward the tissue region is reduced and simplified.

  FIG. 65D shows an example of the ability of the indwelling catheter 16 and the hood 12 to extend and retract from the steerable sheath 14 into the left atrium LA, as indicated by the direction of translation 686. Moreover, FIG. 65E also illustrates an example of the articulation capability of the sheath 14 with the indwelling catheter 16 and the hood 12 extended from the sheath 14, as indicated by the direction of articulation 690. Indwelling catheter 16 may also include a steerable section 688 as well. Depending on the degree of articulation and translational capability, the hood 12 may be directed to any number of locations within the right atrium RA to achieve treatment.

  66A and 66B illustrate yet another variation in which the sheath 14 may be advanced transseptally along its length at least partially as shown in FIG. 66A, as described above. Illustrated. In this variation, rather than using a single intra-atrial stabilization balloon, as shown in FIG. 66B, a proximal stabilization balloon 700 that is inflatable along the atrial septum in the right atrium RA, and A distal stabilizing balloon 702 that is inflatable along the atrial septum in the left atrium LA is inflated along the sheath 14 and the atrial septum AS is sandwiched between the balloons 700, 702 to provide stabilization to the sheath 14 May be. Once the sheath 14 is stabilized, a separate inner sheath 704 may be introduced from the sheath 14 into the left atrium LA. Inner sheath 704 may include an articulatable section 706 as indicated by the direction of articulation 708 and as shown in FIG. 66C. Also, the inner sheath 704 is also translated further distally into the left atrium LA, as indicated by the direction of translation 710, to establish as a short trajectory to the hood 12, and to allow any left atrial LA tissue wall You may access this part. Once the trajectory is determined by the articulation and translation capabilities, the indwelling catheter 16 may be advanced, as shown in FIG. 66E, and the hood 12 is in the tissue region to be treated, such as the pulmonary vein inlet OT. Dilate within the left atrium LA with a relatively direct approach.

  67A and 67B show that the sheath 14 may be advanced at least partially through the atrial septum AS, and the proximal and distal stabilization balloons 700, 702 may be expanded relative to the septum, Another variation is illustrated. Similar to the variation described above in FIGS. 62A-62C, the intra-atrial balloon 660 may be expanded from the distal opening of the sheath 14 to expand and occupy the volume in the right atrium RA. The fiberscope 662 may be advanced at least partially inside the intra-atrial balloon 660 to examine the ventricle, as shown in FIG. 67C. Once the pulmonary vein inlet is visually identified for treatment, the inner sheath 704 is introduced from the sheath 14 into the left atrium LA and articulated and / or translated to target the opening to be treated. It may be directed towards the tissue area. Once the trajectory is determined, a sinus needle 720 having a sinus tip 722 and a hollow lumen that is large enough to accommodate the hood 12 and indwelling catheter 16, as shown in FIGS. 67D and 67E. May be advanced from the inner sheath 704 to contact the balloon 660 and access through the target tissue for treatment. As penetrating tip 722 is extended into pulmonary vein PV, sinus needle 720 is withdrawn, allowing advancement of hood 12 in its low profile to be advanced through penetrating balloon 660. Alternatively, the hood 12 and indwelling catheter 16 may be advanced distally through the lumen of the needle 720, in which case the hood 12 may be expanded outside the balloon 660. Once the hood 12 is in place, the catheter 16 may be partially retracted into the inner sheath 704 such that the hood 12 occupies and seals the through opening through the balloon 660. The hood 12 may also be brought into direct contact with the target tissue for treatment outside the balloon 660, as illustrated in FIG. 67F.

  When utilizing the intra-atrial balloon 660, a direct visual image of the atrium may be provided through the balloon interior. Because imaging devices such as fiberscope 662 have a limited field of view, multiple separate images taken by fiberscope 662 may be processed to provide a composite panoramic image or visual map of the entire atrium. An example is shown in FIG. 68A, where a first recorded image 730 (represented by “A”) may be taken by a fiberscope 662 at a first location in the atrium. A second recorded image 732 (represented by “B”) may also be taken at a second location adjacent to the first location. Similarly, a third recorded image 734 (represented by “C”) may be taken at a third location adjacent to the second location.

  Individual captured images 730, 732, 734 can be obtained via wireless technology such as Bluetooth® (BLUETOOTH SIG, INC, Belleveve, WA) or other wireless protocols while the tissue visualization catheter is in the ventricle. Can be transmitted to an external CPU. The CPU can process photographs taken by monitoring the trajectory of the connection of a fiberscope or CCD camera, while simultaneously processing a 2D or 3D visual map of the patient's ventricle, 68B, is captured by the catheter using any number of known image software that combines the images into a single panoramic image 736. The operator can later use this visual map to perform an intraventricular therapeutic procedure with a visualization catheter still in the patient's ventricle. The generated panoramic image 736 of the ventricle can also be used in conjunction with a conventional catheter that can track the position of the catheter in the ventricle by imaging techniques such as fluoroscopy, but cannot provide direct real-time visualization. Can also be used.

  Potential complications when cauterizing atrial tissue are potentially penetrating or cauterizing outside the heart H and damaging the esophagus ES (or other adjacent structure) located in close proximity to the left atrium LA It is. Such complications may occur when the operator cannot infer the location of the esophagus ES with respect to the tissue being cauterized. In the example safety mechanism shown in FIG. 69A, the light source or ultrasound transducer 742 can be inserted orally into the esophagus ES and advanced until the catheter light source 742 is positioned proximate or adjacent to the heart H. Some catheters 740 may be attached or threaded. During an intravascular ablation procedure in the left atrium LA, the operator visually detects (or through ultrasound, etc.) the light source 742 in the form of a background glow behind the tissue to be cauterized as an indication of the location of the esophagus ES. In addition, an imaging element may be used. Different light intensities that provide different brightness or glow in the tissue can vary to represent different safety tolerances, for example, the stronger the light source 742, the more the detection of the glow in the left atrium LA by the imaging element The safety margin that is easier and prevents esophageal perforation is potentially even greater.

  An alternative method is to insert an ultrasound crystal source at the end of the oral catheter instead of a light source. An ultrasonic crystal receiver can be attached to the distal end of the hood 12 in the left atrium LA. Through communication between the ultrasonic crystal source and the receiver, the distance between the ablation tool and the esophagus ES can be calculated by the processor. When a source in the heart H approaches a receiver located in the esophagus ES and the ablation probe indicates that it is approaching the esophagus ES at the ablation site, a warning, for example, a beep or vibration on the handle of the ablation tool It is possible to operate in the form of The RF source can also cut off the supply to the electrode if this occurs as part of the safety measure.

  Another safety measure that may be utilized during tissue ablation is the use of color changes in the tissue being cauterized. One particular advantage of the direct visualization system described herein is the ability to observe and monitor tissue in real time and in detailed colors. Thus, as illustrated in the side view of FIG. 69C, the hood 12 is placed against the tissue T to be cauterized, and the blood in the hood 12 is replaced with transparent saline. The imaging element 532 provides off-axis visualization of an ablation probe 536 placed against the tissue surface for treatment, as illustrated in FIG. 69B, by a representative real-time display image viewed by the user on the monitor 128. May be provided. As represented by the heated tissue 745 in FIG. 69E, when the tissue is heated by the ablation probe 536, the ablated tissue 744, as shown in FIG. The color change resulting from the cauterized tissue 744 may be detected and monitored on the monitor 128 as it turns to the pale white shown. The user may ensure that the proper amount and location of tissue is ablated and not overheated by monitoring real-time images and tracking color changes on the tissue surface.

  Moreover, real-time images are typically an indication of endocardial collapse and may be monitored for the presence of vapors or microbubbles emanating from the ablated tissue. If detected, the user may stop ablation of the tissue to prevent further damage from occurring.

  In another indication of tissue damage, FIGS. 69F and 69G show the release of tissue debris 747, eg, charred tissue fragments, coagulated blood, etc., due to endocardial disruption or tissue “popping” effects. The resulting tissue crater 746 as well as the resulting tissue debris 747 may be visualized as shown in FIG. When collapse occurs, ablation may be stopped by the user, and debris 747 may be contained within the hood 12 to prevent release into the surrounding environment, as shown in FIG. 69G. The contained or captured debris 747 in the hood 12 is drawn into the patient by retracting the debris 747 by aspirating proximally from within the hood 12 and into the indwelling catheter, as shown by the aspiration direction 748 of FIG. 69H. It may be drained and removed from the body. Once the captured debris 747 is removed, ablation may be completed on the tissue and / or the hood 12 may be repositioned to treat another region of tissue.

  Yet another method for improving ablation therapy on tissue and improving patient safety is shown in FIGS. 69I-69K. The hood 12 may be placed against blood in the hood 12 that is replaced by the tissue T to be treated and saline as described above and as shown in FIG. 69I. Once the appropriate tissue area to be treated is visually identified and confirmed, the saline in the hood 12 until the underlying tissue is at least partially drawn into the hood interior, as shown in FIG. 69J. A negative pressure may be formed in the hood 12 by pulling in and generating a suction force. The temporarily attached tissue 749 may be in stable contact with the hood 12 and the ablation probe 536 may be attached so that the tissue 749 is heated in a consistent manner, as illustrated in FIG. 69K. The contacted tissue 749 may be contacted. When ablation is complete, the attached tissue 749 may be released and the hood 12 may be repositioned to achieve further treatment on another tissue region.

  When treating symptoms such as cardiac arrhythmia, atrial flutter, ventricular fibrillation, ablation probes may be introduced through tissue imaging and manipulation catheters, and the ablation process is monitored under direct visualization as described above. May be. In addition to visualization, additional features or instruments may be utilized with the catheter to detect tissue parameters and further monitor the ablation procedure before, during, and / or after the ablation process. For example, parameters such as detection of the thickness, temperature, impedance characteristics, etc. of the penetrating tissue region may also be detected and monitored.

  One variation is shown in the perspective view of FIG. 70A, which illustrates the hood 12 in its expanded configuration positioned with the imaging element 532 at the distal end of the indwelling catheter 16 as described above. Within the catheter 16, one or more lumens or actuation channels are defined through which one or more ablation needle electrodes 750 disposed on the ends of one or more corresponding probe shafts 752 are advanced. May be. In addition, one or more optional temperature sensors may be positioned within the needle electrode 750 to detect an elevated temperature of the ablated tissue, as described in further detail below.

  FIG. 70B shows a perspective view of the needle electrode 750 disposed on the hood 12 and each probe shaft 752. Although this example illustrates three needle electrodes positioned adjacent to each other, one, or two needle electrodes, or more than three needle electrodes may be utilized. One or more needle electrodes 750 can traverse along the axis of the actuation channel. FIG. 70C shows a detailed perspective view of the needle electrode 750 extending from the probe shaft 752. Each needle electrode may consist of a needle body having a diameter of, for example, about 0.022 inches (or a range between 50% or more and less). The needle body is covered by an insulating coating 756 and protrudes into the tissue and / or into the penetrating tip 754 for penetrating therethrough. The base of each needle may also include an exposed ablation return electrode 758, eg, an RF electrode, for performing transmural lesion ablation on tissue penetrated by the tip 754.

  In addition, one or more of the needles may also include a temperature sensing element 760, eg, a thermocouple sensor, thermistor, positioned within the needle lumen. The underlying tissue where the needle electrode 750 may penetrate beyond the tissue to be treated or may have a different impedance or higher than the target tissue when the needle is penetrated into the ablated tissue Sensing element 760 may be used to detect whether needle electrode 750 is penetrating into a layer, eg, a fat layer.

  FIG. 71 shows another variation of the hood 12 after being placed in an open structure that may be utilized with an ablation probe to achieve ablation therapy. Prior to placement of an instrument, such as needle electrode 750, clean balloon 770 may be inflated within open hood 12, for example with a contrast agent. The inflated balloon 770 eliminates opaque body fluids that may be inside the interior of the hood 12 and allows the imaging element 532 to visualize the tissue surface when contacted against the tissue surface.

  72A through 72E illustrate one method that may utilize the balloon 770 to achieve ablation treatment. As shown in the perspective views of FIGS. 72A and 72B, the hood 12 is deployed when the indwelling catheter 16 is initially directed toward the tissue region to be cauterized. The balloon 770 may be inflated within the hood 12, as shown in FIG. 72C, and the balloon 770 and the hood 12 are fully pressed against the tissue region T from between the balloon surface and the tissue surface. The underlying body fluid 772 may be fully replaced. The imaging element 532 is used to clearly visualize through the balloon 770 to the underlying tissue surface, as shown in FIG. 72D, and to adapt the location of the hood 12 to the appropriate area of the tissue to be treated. Also good. If the hood 12 needs to be repositioned, it may simply be repositioned with the balloon 770 inflated. Once the proper tissue location has been established, the balloon 770 may be deflated and retracted back into the lumen, allowing continuous saline flow to flow through the hood 12 as shown in FIG. 72E. It may be injected into to eliminate opaque body fluids such as blood and allow a therapeutic tool such as an ablation needle 750 to be placed in the hood.

  73A-73F shows the hood 12 in contact with the tissue surface T with saline flow from the irrigation channel of the catheter 16 injecting into the hood 12 while under visualization from the imaging element 532. A detailed side view is illustrated. When a proper seal between the hood 12 and the tissue surface T is established and visually confirmed, the needle electrode 750 may be placed and advanced into the hood 12, as shown in FIG. 73B. . Once the needle penetrating tip 754 has been pierced into the tissue T, the penetrating needle 754 is advanced until the exposed ablation return electrode 758 contacts the tissue surface, as illustrated in FIGS. 73C and 73D. May be. On the other hand, a sensor 760 positioned within the needle may be used to detect and monitor the temperature and / or impedance of the contacting tissue T.

  The change in impedance detected by sensor 760 occurs when the needle begins to enter tissue. As sensor 760 enters the layer below the tissue layer, fat generally has a higher impedance value compared to tissue, resulting in a higher impedance measurement. This detected change in impedance activates the ablation procedure through the electrode exposed at the needle exposed by the insulation 756 and the electrode 758 at the base of the needle, for example, to ablate on the tissue T for a depth of 15 mm. You may be instructed to start. The average thickness of the tissue wall typically ranges between 8 mm and 15 mm. For example, ablation to an exemplary depth of 15 mm produces transmural lesions that pass completely through the tissue to the fat layer, unlike current RF devices that produce discontinuous lesions or lesions that do not extend through the entire tissue. It may help to ensure that it is done.

  As shown in FIG. 73E, a lesion 780 is created that is thoroughly pierced through the tissue wall. Withdrawing electrode 750, imaging element 532 may also provide real-time in-vivo visual confirmation of lesion 780 formation and location before fully retracting hood 12 and catheter 16, as shown in FIG. 73F. Good. Visual confirmation also provides a way to verify the ablation area, allowing the user to repeat the ablation process if a disturbance occurs during any stage of the procedure. The entire process can be repeated with different target areas until the desired transmural lesion scar pattern is generated.

  FIG. 74A shows a partial cross-sectional view of a device that forms a transmural lesion 782 in the right atrium RA of the heart via intravascular access through the inferior vena cava IVC as a possible variation of the application. As shown in FIG. 74B, the hood 12 and catheter 16 are constructed as described in US patent application Ser. No. 11 / 763,399, filed Jun. 14, 2007, incorporated by reference above. And is introduced transseptally into the left atrium using either of the instruments and using the ablation electrode 750 around the entrance of the pulmonary vein as shown in FIG. 74C. Additional transmural lesions 784 may be generated.

  In addition, while detecting and monitoring the ablation process, multiple ablation probes positioned in various arrangements can be placed to cauterize linear or annular lesions. Similar to the structure described above, eg, in FIG. 50A, FIGS. 75A and 75B can be used to isolate a linear lesion by placing multiple ablation probes 798 perpendicular to one or more indwellable arms 794,796. Fig. 4 illustrates additional structures that can be generated in steps. The indwellable arms 794, 796 may be folded and hidden within the handle 790, and upon placement, the arms 794, 796 will swing around the hinge or pivot axis 792, eg, as shown in FIG. You may open it in a letter shape. The probe needle 798 located along the deployed arm 794, 796 may then be swung from parallel to vertical structure with respect to the handle 790 before the linear transmural lesion is performed as described above. Further, each of the one or more probe needles 798 may include a temperature sensor within the needle body to detect and monitor the condition of the ablated tissue.

  FIGS. 76A and 76B illustrate yet another structure that can generate an annular lesion through ablation needle probe tip 800 in a single step. A plurality of ablation needles 802, each extending from an articulatable member, which may be made of a shape memory material such as a nickel-titanium alloy, can be pivoted via a pivot axis or hinge 804, or can be deployed from an actuation channel. Once done, it may be bent in advance at the elbow. When housed or restrained within the indwelling catheter 16, the ablation needle 802 may be longitudinally aligned with a thin structure, as shown in the perspective view of FIG. 76A. However, as it is advanced into or beyond the hood 12, each of the needles 802, either through actuation from the user or through self-configuration, has its deployed radial as shown in FIG. 76B. The projecting position may be reconfigured. Ablation needle 802 may be expanded to various shapes, such as an annular shape as shown, or other structures. This structure may be particularly useful for ablation of left atrial tissue in or around the entrance of the pulmonary vein. Furthermore, one or more of the ablation needles 802 contain a temperature sensing probe positioned within the needle itself for insertion into tissue to detect and monitor temperature and / or impedance during the ablation process. May be.

  FIG. 77A shows another variation of the assembly diagram for the transmural tissue parameter detection needle. As shown, the transmural needle assembly 810 may be used in conjunction with a tissue visualization catheter for advancement through the hood 12. The probe 818 is configured to detect the degree of transmural sinus penetration of the needle into or through the target tissue to ensure complete transmural ablation of the target tissue under direct visualization. May be. The transmural needle assembly 810 generally includes a distal tip having a probe 818 and optional integrated ablation capability, and a catheter body 816 (eg, catheter, introducer, etc.) that connects the probe 818 to the handle assembly 812. And / or a cylindrical extrusion mold such as a sheath). The probe assembly 818 and catheter body 816 may be introduced into the indwelling catheter 16 from its proximal end and advanced therethrough and into the hood 12.

  As shown in FIG. 77B, the handle assembly 812 generally also includes a needle sinus depth indicator 814 and an actuator, eg, a push / rotate knob, to advance or retract the distal transmural needle probe. Good. FIG. 77C shows a perspective view of probe 818 including ablation electrode 820 positioned on the distal end of catheter body 816 and first temperature sensor 826 positioned over electrode 820. Penetrating needle 822 extends adjustably distally from electrode 820 terminating in penetrating tip 824. A sensor assembly 828 used to detect various tissue parameters may be viewed housed within the lumen of the needle 822.

  FIG. 77D shows a detailed perspective view of the probe 818. The needle body itself 822 may have a diameter of, for example, 0.005 inches, and the outer diameter thin wall needle has a plurality of pores or openings 836 defined along the needle body. The outer surface of the needle 822 is also 834 that may be largely insulated except for a short exposed portion at the distal traumatic end, eg, the penetrating tip 824. Proximal to needle 822 is an ablation surface 820 that can be incorporated to provide ablation energy, as described above. In addition, the sensor assembly 828 contained within the needle lumen may include one or more sensors for detecting and monitoring tissue parameters. In this variation, a second temperature sensor 830 may be included along with an optional impedance sensor 832.

One variation of impedance sensor 832 may utilize two electrodes. This is shown schematically in FIG. 78 where V and I represent voltage 846 and current, respectively. Impedances 840, 842 (Ze) and 844 (Z _L ) represent the impedance of the first and second electrodes and the load (eg, from blood, tissue, fat, etc.), respectively. Either voltage 846 is applied and current I is measured, or current is applied and voltage is measured. These may be sufficiently high frequency AC signals so that the tissue is not stimulated. The frequency may also be selected to optimally differentiate between different loads of interest. The V / I ratio results in a measured impedance, Zm = Ze + Z _L + Ze, where one of the Ze electrodes can be attached to the needle 822 as an impedance sensor 832 while the remaining Ze is , Can be attached to the wall of the needle 822.

In particular, Ze can be greater than the value of Z _L , especially for small surface area electrodes, so the electrode impedance may be combined with the desired specific load impedance. In general, Ze is a function of electrode material and electrode shape. As the electrode gets smaller, the value of Ze increases. One way to compensate for this is to use a four-point method, as shown in FIG. Here, the voltage V or current I is imposed across the two electrodes as before. However, two additional electrodes 848 (E ₃ ) and 850 (E ₄ ) are introduced and attached to a high input impedance _bioamplifier 852 that simply measures the voltage between the two electrodes (V _MEASURED ). Since the bioamplifier 852 has a high input impedance (Z _IN >> Ze), the impedance of the electrodes 848 (E ₃ ) and 850 (E ₄ ) is negligible. Electrodes 848 (E ₃ ) and 850 (E ₄ ) measure the voltage across the spatial region of interest with current flowing through them imposed by the two first electrodes. Again, the V / I ratio is a measure of impedance as the entire four electrode assembly is moved around the region of interest. In this bioamplifier structure, E ₃ can be attached to the distal impedance sensor 832 while E ₄ can be attached to the wall of the transmural needle 822.

  Rather than using thermocouples, thermistors, ultrasonic crystals, etc. to measure tissue temperature, another variation utilizes a fiber optic temperature sensor along the needle 822. A thermosensitive layer of dye, such as a high sensitivity phosphor (phosphor), can be placed along the distal portion of the thin fiberscope 860 that can be positioned within the lumen of the transmural needle 822. When the needle 822 is inserted into the tissue and the tissue to be ablated, the dye heat-sensitive layer is transferred from a first color 862 indicating a first temperature to a first temperature, as shown in FIGS. 80A and 80B, respectively. May change to a second color 864 indicating a different second temperature. The rate of change in the color of the emission detected by the fiberscope 860 may be used to determine the local distal temperature of the transmural needle 822.

  To correlate the rate of change in dye color with temperature, the relationship between light intensity versus time fluorescence decay rate τ, as shown in FIG. 81, and between decay rate and temperature, as shown in FIG. The relationship may be utilized by the processor to calculate the local temperature correlated.

  To control the depth of needle puncture into the target tissue, the handle assembly 812 may include a needle puncture depth indicator 814 along the handle, as shown in the perspective view of FIG. The indicia 814 has a position marker 870 that moves along a series of tones 872 that indicate depth, thereby making the depth of tissue sinus penetration performed by the transmural needle 822 distal to the end of the catheter body 816. May be indicated. The protrusion of the transmural needle 822 may be controlled by a needle advancement control 874, for example, a push / pull mechanism or a rotary knob at the end of the handle 812.

  An example illustrating one method of determining the thickness of a target tissue layer that may utilize a penetration depth marker as well as impedance sensing is shown in FIGS. 84A and 84B. When the needle 822 is fully retracted into the catheter body 816, as shown in FIG. 84A, the impedance sensor 832 within the needle 822 may cause the surrounding fluid (peripheral blood 880 or as tissue is visualized in the hood 12). The impedance of any of the injected saline) or the space above the target tissue may be recorded. Additionally and / or alternatively, the temperature may also be detected in the needle 822 by the temperature sensor 830 in the needle 822, which should correlate with the temperature detected by the temperature sensor 826. As shown in FIG. 84B, a position indicator 870 along the handle 870 in this structure indicates the position at the reference or reference location, indicating that the needle 822 is fully retracted.

  As shown in FIG. 85A, when the transmural needle is advanced into the target tissue T and pierced, the impedance sensor 832 will immediately cause a difference in intrinsic material properties between the blood 880 and the tissue T. An increase in impedance may be detected. This detected change in impedance alerts the user that the transmural needle 822 is in contact with the tissue T. Whether the needle 822 has been inserted into the desired tissue by comparing the impedance detected by the sensor 832 with a predicted impedance of the target tissue T from a standard impedance value determined by tissue resistivity and electrode geometry. It can be used to verify whether. As shown in FIG. 85B, a position marker 870 along the handle 812 indicates to the user the depth at which the needle 822 has punctured into the tissue T.

  FIG. 86A illustrates when the transmural needle 822 is fully pierced through the entire layer of target tissue T. FIG. If impedance sensor 832 indicates a change in impedance due to contact with different substances such as endocardial tissue, pericardial tissue, blood, fat, etc., the user is warned that a complete transmural sinus has been made. In addition, as shown in FIG. 86B, the position indicator 870 on the handle 812 in this case indicates the thickness of the target tissue layer and the depth at which complete transmural sinus penetration is performed. Once needle 822 is fully pierced into tissue T, saline 882 may be injected into the surrounding tissue through a pore or opening 836 along the wall of transmural needle 822 while catheter body 816 is infused. The ablation electrode 820 at the distal end is charged.

  As the ablation electrode 820 begins to cauterize the tissue T, a thin layer of saline formed around the needle 822 in the tissue T may act as a conductive medium to carry radiant energy to additional tissue surfaces. . This in turn helps to generate wider lesions using the same amount of power at the ablation electrode 820 without tissue desiccation and / or blood clotting. It may also help cool the area around the needle 822.

  Even a bipolar RF electrode or a ring electrode positioned between the needle tip 824 and the ablation electrode 820 can be configured to further generate a wider lesion. One advantage of this is that the lesion may begin at the needle 822 and then grow radially therefrom. This may be advantageous for discontinuous lesions that are targeted by the needle sensor 828 (impedance and temperature) and subsequently target that region in the resulting central myocardial wall. An alternative RF ablation technique includes stimulation RF applied through needle 822 and ablation electrode 820, and the amplitude of the RF is separately controlled and modulated by feedback from temperature sensors 826, 830.

  After positioning the transmural needle 822 across the target tissue T, FIG. 87A shows an optional subsequent method that ensures that the full depth tissue layer is cauterized to form a complete transmural lesion. This may be accomplished by determining the temperature at the tissue surface and the distal adjacent end of the tissue layer using temperature sensors 826 and 830, respectively. After puncturing through the entire layer of target tissue T, as shown, the transmural needle 822 may be slightly retracted, for example, over a distance of at most about 0.5 mm. The ablation electrode 820 may then be powered to ablate the target tissue T starting from its surface as indicated by the area of heated tissue 890 emanating from the electrode 820 shown in FIG. 87A. The tissue T may be heated to a temperature of at least 50 ° C. so as to irreversibly damage or cauterize the tissue. Full transmural ablation is achieved when temperature sensor 826 detects a surface temperature above 50 ° C. or at a temperature at which tissue T begins to show signs of ablation that may be detected visually as described above. The temperature sensor 830 positioned within the needle 822 similarly moves the ablation electrode 820 until it detects a temperature that is greater than 50 ° C. or any other temperature that indicates that full depth tissue has been completely cauterized. This may be followed by a step of holding in position. Ablation may be stopped automatically if a tissue temperature of 50 ° C. or higher and up to 90 ° C. or higher is detected, or energy stops being released from the electrode, or Delivery from the electrode may cease and further ablation or damage to the tissue may be prevented or suppressed. FIG. 87B shows a gradient of heated tissue 892 through tissue T that extends from electrode 820 to temperature sensor 830 in needle 822.

  Such a method and apparatus allows a user to more reliably ensure complete transmural ablation through full depth tissue T, while at the same time when excessive radiant energy is generated by long-term electrode-surface contact. The cauterized tissue near the surface may be prevented from overheating and / or drying or blood clotting.

  FIG. 88A shows a perspective view of probe 818 and catheter body 816 being advanced through indwelling catheter 16 and into and through hood 12 for ablation and / or tissue parameter detection. FIG. 88B shows an example where the probe 818 may be advanced into the underlying tissue for ablation and detection while under direct visualization by the imaging element 532. Transmural ablation may be performed in the hood 12 when an opaque body fluid such as blood is replaced from the hood 12 with physiological saline. Ablation under such conditions allows the user to visualize high resolution images of the actual ablation site in vivo and in real time, and as mentioned above, any indication of tissue overheating, charring, or desiccation, or It may be possible to immediately detect, isolate and / or respond to any signs of blood clotting.

  FIGS. 89A and 89B are alternative perspective views having a plurality of transmural needles 902 disposed in a ring configuration along a support ring 900 positioned around the circumference of the opening of the hood 12. Indicates. The transmural needle 902 disposed in such a structure promotes ring ablation and the cauterized ring-shaped lesion completely penetrates the target tissue layer T to form a complete transmural lesion as described above. It may be possible to ensure that.

  In yet another variation, a plurality of transmural needles can be arranged in a linear configuration along a linear ablation electrode, as shown in FIGS. 90A and 90B. A transmural needle 916 disposed in this configuration can facilitate transmural linear ablation. The linear distal portion 912 can be rotated 90 degrees at the junction 914 to be parallel to the support arm 910 as well as the axis of the indwelling catheter 16 from its vertical configuration, as shown in FIG. 90B. . In the pivoting configuration shown in FIG. 90A, the portion 912 may be retractable into the catheter 16. FIG. 90C illustrates an example of a deployed portion 912 in which the transmural needle 916 is advanced into the target tissue T while under visualization from the imaging element 532 by the hood 12.

  FIG. 91 is a detailed perspective view of another variation of the transmural subsurface probe, where several additional temperature sensors may be placed along the length of the needle, for example within each pore or opening. Indicates. Saline may be injected past the temperature sensor and through the opening as described above, or the saline may be omitted entirely. In the variation shown, the first temperature sensor 920 may be positioned at a first proximal location along the needle, and the second temperature sensor 922 is a second distal to the first location. The third temperature sensor 924 may be located at a third location distal to the second location, and the fourth temperature sensor 926 may be located distal to the third location. May be positioned at the fourth location. Although three additional temperature sensors are shown along the needle length, fewer or additional sensors depending on the needle length and the desired number of temperature measurements along the needle length May be used. Furthermore, the temperature sensors may be evenly spaced from each other, but this need not be the case.

  An example of this needle positioned in tissue is shown in FIG. 92A, showing temperature sensors 920, 922, 924 positioned in the tissue layer. Multiple sensors can determine the temperature profile of the entire tissue layer along the needle axis. Generally, when an ablation electrode 820 with saline wash 928 and / or surface cooling is used, the warmest tissue region is typically about 3.2 mm to 3.4 mm away from the tissue-electrode interface. . This suggests that when a conventional ablation probe with surface cooling is utilized, during the ablation process, the region of tissue in the middle of the tissue layer T is most likely to be overheated or dried first. . Using the measured temperature profile across the depth of the tissue layer, the user may be able to determine the location of the warmest tissue region and later power the ablation electrode accordingly. Thus, the risk of endocardial collapse and tissue crater formation (tissue rupture in the heart wall) during cardiac ablation can be significantly reduced. Further, this temperature profile sensing may be used in combination with visual monitoring of the tissue surface, as described above. FIG. 92B shows a position indicator 870 that correlates with the position of a needle extending through the length of tissue T.

  FIG. 93A shows a transmural surface including an intramural cooling needle 930 having a cooling probe 932 that may be advanced from the catheter body 816 adjacent the probe and also penetrated into tissue adjacent the probe. Another variation of the lower probe is shown. The intra-wall cooling needle 930 may have an outer diameter of, for example, 0.005 inches or less, and about 3 mm to 4 mm (or preferably about 3 mm) from the catheter body into the tissue, as indicated by depth 934. .4 mm) may extend. The cooling probe 932 may be configured to cool the tissue in contact with the needle at the distal end. When the transmural needle 822 is inserted into the tissue and ablation is initiated, the cooling probe 932 serves to cool the central portion of the tissue layer (approximately 3.2 mm to 3.6 mm away from the contact surface). If the electrode 820 is cauterized there, there is a possibility that a peak structure temperature is generated. This may also help to generate a linear temperature profile across the ablated tissue, resulting in the formation of wider and positionally more evenly distributed transmural lesions. , Further reduce the risk of endocardial disruption. The cooling intensity and location can be varied accordingly by monitoring the tissue temperature profile provided by the transmural subsurface probe. FIG. 93B illustrates a perspective view of a transmural probe used in conjunction with a tissue visualization catheter and ablation probe 536.

  FIG. 94 shows yet another variation of the transmural probe with multiple impedance sensors that provide an impedance profile across the target tissue. Similar to the variation in the step of determining the temperature profile, the plurality of impedance sensors can be fixed along the longitudinal axis of the needle. As shown, the first impedance sensor 942, the second impedance sensor 944, and the third impedance sensor 946 may be located along the length of the needle body. In this structure, instead of a single impedance measurement, an impedance profile across the tissue layer is recorded. Also, the entire dome surface that is proximal to the needle can be a junction that acts as a proximal impedance sensor 940. In addition, a plurality of temperature sensors 920, 922, 924 (as described above) may also be alternately aligned along the needle to detect the temperature profile as well.

  A plurality of closely spaced impedance sensors along the needle shaft can be arranged in a bipolar structure for measuring signals from tissue in close proximity to the needle. This can also be an extension of the above four-point impedance method to more than two electrodes placed between two electrodes that inject signals for impedance measurement. The plurality of impedance electrodes 940, 942, 944, 946 can also be used to target ablation sites in the myocardium by using signal characteristics or pacing methods such as pace mapping or tuning mapping. Pacing can be performed in a unipolar configuration using a long return electrode for the pacing pulse. This may increase the spatial resolution of the pacing method to a discontinuous single electrode on the probe rather than two electrodes when bipolar pacing is performed.

  95A and 95B are side views of yet another variation of a transmural subsurface probe that has no ablation function and is fixed circumferentially at the distal end of the lumen that fits into a conventional ablation catheter 950. FIG. And a perspective view is shown. This structure allows transmural ablation to be performed with any ablation catheter selected by the user. One or more transmural probes 952, 954 may be positioned adjacent to the ablation probe 536. Since the needles 952, 954 may extend past the ablation probe 536, the needle may be penetrated into the target tissue T distal to the ablation probe 536. The sensing assembly housed within the probes 952, 954 may detect transmural sinus as well as transmural ablation by the ablation probe 536 as described above.

  An alternative variation of transmural needle 964 attached to the distal end of ablation probe 960 is shown in the side view of FIG. The transmural needle 964 may extend distally from the ablation probe 960 along a flexible section 962 that allows the needle 964 to be temporarily bent. The flexible section 962 can be made of a coil or spring or other plastic / elastomer material. Furthermore, the inclusion of the flexible section 962 allows the ablation catheter 960 to pivot once the transmural needle 964 is pierced into the target tissue T. This allows the user to cauterize at a more free angle, such as when utilizing the side of the ablation catheter 960 relative to the tissue surface, as shown.

  97A and 97B show another variation of a side view and an end view of a transmural needle 974, where the needle 974 protrudes radially from the side of the electrode 972 of the catheter 970, respectively. When the needle 974 is positioned in a radial location, it may always be positioned outside the deflection direction of the catheter 970, as indicated by the catheter deflection direction 976. This particular variation may be useful for high torque catheters that are designed to deflect optimally in a fixed plane. In another variation, the needle 974 can be extended out of the distal tip due to its rapid exchange capability, and can be a straight needle, or a needle that is curved to always be placed against the catheter deflection. Allows insertion.

  98A and 98B show another variation of a transmural needle having a helical structure instead of a straight needle structure. The needle 980 may simply be rotated into the tissue T in order to penetrate the tissue with the helical needle 980. Similar to the above embodiments, temperature and / or impedance sensor 828 may be attached to the distal and proximal ends of needle 980. Alternatively, the helical needle 980 can also include multiple temperature and / or impedance sensor rings along the needle axis. Since the helical meridian needle 980 has a larger contact area with the sinus tissue T compared to the straight needle, the structure can be used at the same power level, as indicated by the width of the heated tissue gradient 982, at the same power level. Compared to, it may be possible to form a wider and deeper lesion. Needle 980 may also be capable of measuring impedance and / or temperature profiles across the transmural layer of tissue. In addition, the helical needle 980 may also be used to manipulate tissue according to user and procedure needs.

  FIG. 99 shows yet another variation of the transmural needle with one or more transparent visualization balloons 990 secured along the length of the transmural needle 822. When balloon 990 is pressed against tissue and when the imaging element is proximal to balloon 990, balloon 990 can be inflated laterally of the needle to provide visualization of the tissue surface. Once the balloon 990 is deflated, transmural sinus and ablation with the needle 822 can be performed as described above by forcing the needle 822 into the target tissue. In this configuration, the balloon 990 can also be inflated again to expand the width of the lesion and / or visualize the surface condition of the lesion wall.

  In the variation shown in FIG. 100A, the transmural needle is as described in US Patent Publication No. 2006/0084945 A1 filed Jul. 6, 2005, which is incorporated herein by reference in its entirety. And configured with a robot precision control assembly 1000. The hood 12 is attached to the distal end of the robotic precision motion control catheter 1002 and may be articulated via the articulatable section 1004. The transmural needle 816 may be advanced within the hood 12 as shown in FIG. 100B while under visualization from the imaging element 532, and once the robotic catheter 1000 controls the movement of the hood 12, The transmural needle 816 may be accurately moved along the tissue surface during subsurface investigations and ablation procedures.

  Applications of the disclosed invention described above are not limited to certain treatments or areas of the body, but may include any number of other treatments and areas of the body. Modifications of the above methods and apparatus to carry out the invention and variations of aspects of the invention that are apparent to those skilled in the art are intended to be within the scope of the disclosure. In addition, various combinations of aspects between examples are also contemplated and are considered to be within the scope of the present invention as well.

Claims (192)

An indwelling catheter defining at least one lumen therethrough;
A barrier or membrane protruding distally from the indwelling catheter and defining an open region therein, the open region being in fluid communication with the at least one lumen;
A visualization element disposed inside or along the barrier or membrane for visualizing tissue adjacent to the open area;
An ablation energy transfer surface that can be positioned to cauterize tissue contained within or within the open area;
A tissue imaging and treatment system comprising: The system of claim 1, further comprising a delivery catheter through which the indwelling catheter is deliverable. The system of claim 1, wherein the indwelling catheter is steerable. The system of claim 3, wherein the indwelling catheter is steered by pulling at least one wire. The system of claim 3, wherein the indwelling catheter is steered via computer control. The system of claim 1, wherein the barrier or membrane comprises a flexible material. The barrier or membrane defines a peripheral contact edge for placement relative to a tissue surface such that the tissue surface extends along or inside the contact edge, and the energy transfer surface is visualized The system of claim 1, comprising an electrode electrically connectable to the tissue surface area for cauterizing the tissue. The system of claim 1, wherein the barrier or membrane is configured to be reconfigured from a low profile delivery structure to an expanded indwelling structure. The system of claim 8, wherein the barrier or membrane is configured to self-expand into the expanded deployment structure. The system of claim 8, wherein the barrier or membrane comprises one or more support posts along the barrier or membrane. The system of claim 1, wherein the barrier or membrane is conical. The system of claim 1, wherein the visualization element comprises at least one optical fiber, CCD imager, or CMOS imager. The system of claim 1, wherein the visualization element is disposed within a distal end of the indwelling catheter. The system of claim 1, wherein the visualization element is articulatable off axis relative to a longitudinal axis of the indwelling catheter. The system of claim 1, further comprising a fluid reservoir fluidly coupled to the barrier or membrane. The system of claim 15, wherein the fluid comprises saline, plasma, water, or a perfluoro liquid. The system of claim 1, wherein the barrier or membrane further comprises a distal membrane extending into the open area such that the energy transfer surface comprises an ablation electrode disposed circumferentially over the distal membrane. . The barrier or membrane has a radius near the distal edge of the barrier or membrane that partially covers the open region such that the distal membrane defines an opening through which the ablation electrode can extend. The system of claim 1, further comprising a distal membrane extending inwardly in the direction. The system of claim 1, wherein the energy transfer surface comprises an ablation electrode, the ablation electrode being articulatable. The system of claim 1, wherein the energy transfer surface comprises an ablation electrode, and the ablation electrode comprises a monopolar or bipolar radio frequency electrode. The system of claim 1, wherein the energy transfer surface is reconfigurable from a first linear profile to a second extended profile. 24. The system of claim 21, wherein the second extension profile defines a linear structure that is transverse to the longitudinal axis of the indwelling catheter. The system of claim 21, wherein the energy transfer surface is housed in a linear housing that is articulatable between a linear profile and an extended Y-shaped profile. The system of claim 21, wherein the second extension profile defines an annular structure. The system of claim 1, wherein the energy transfer surface is disposed circumferentially over a contact lip or edge of the barrier or membrane. The system of claim 1, wherein the ablation probe comprises a plurality of needles. 27. The system of claim 26, wherein the plurality of needles are extendable from a contracted structure to an ablation structure. The system of claim 1, further comprising an occlusion balloon that is expandable to an inflated shape that is large enough to occlude the vessel lumen. The system of claim 1, further comprising a first articulatable tissue grasper positioned on a first support member extending distally from the barrier or membrane. And further comprising a second articulatable tissue grasper positioned on a second support member extending distally from the barrier or membrane, the second tissue grasper comprising the first tissue grasper. 30. The system of claim 29, wherein the system is articulatable independently. And further comprising a length of wire or suture that is slidably passed through the tissue grasper, the first end of the wire or suture being attached to the tissue imaging and treatment system, 30. The system of claim 29, wherein the second end of the suture is pulled from outside the patient's body. The system of claim 1, further comprising an intra-atrial balloon disposed at a distal end of the catheter, wherein the balloon is expandable from a thin deflated structure to an inflated structure. 34. The system of claim 32, wherein the inflation structure occupies up to 75% or more of the volume of the atrium in the patient's heart. 35. The system of claim 32, wherein the intra-atrial balloon comprises one or more radiopaque markers. A tissue imaging and treatment system for treating a tissue region in the heart, wherein the heart has a ventricle, the ventricle containing blood including a tissue surface;
A catheter body having a lumen;
A visualization element disposed adjacent to the catheter body, the visualization element having a field of view;
A translucent fluid source in fluid communication with the lumen;
A barrier or membrane expandable from the catheter body to limit the replacement of blood by the translucent fluid flowing from the lumen between the visualization element and the field of view;
An ablation energy transfer surface positionable to cauterize the tissue within the field of view;
A system comprising: The membrane or barrier is disposed around an open area between the visualization element and the field of view, and the fluid source sufficiently replaces the blood from the open area while the heart is beating. 36. The system of claim 35, wherein the system is configured to infuse a translucent fluid to allow optical imaging of the tissue surface through the open area. 38. The system of claim 36, wherein the membrane is expandable from a low profile delivery structure to an expanded structure to encompass an imaged tissue surface that is larger than a cross section of the catheter. 38. The system of claim 37, further comprising a frame in the expanded structure that supports the membrane outside the open area. 40. The system of claim 38, wherein the frame comprises a shape memory alloy and the visualization element is supported by the frame. The barrier or membrane comprises a hood, and the barrier or membrane has a contact edge surrounding the opening adjacent to the field of view, so that in use, translucent fluid from the lumen passes through the opening. 36. The system of claim 35, wherein the system is released into the ventricle and the energy transfer surface is translatable through the opening. 36. The system of claim 35, wherein the barrier or membrane has an inner surface and an outer surface, and a volume disposed within the inner surface is greater than a volume disposed between the inner surface and the outer surface. The catheter body is included in a steerable catheter, the steerable catheter having an elongated proximal portion and an articulatable section adjacent the barrier, the steerable section comprising a plurality of links. 36. The system of claim 35, wherein the system is steerable from a proximal end of the proximal portion to impose a smooth axial bend on the catheter body. The catheter body includes a working lumen for slidably receiving the energy transmission surface; a lumen for receiving a steering element to deflect the catheter body laterally; and a translucent fluid flow lumen; 36. The system of claim 35, comprising an image conduit for transmitting an image of the tissue surface from the visualization element. The barrier or membrane further comprises a distal membrane that extends partially over the open area such that the distal membrane defines an opening through which the energy transfer surface can extend. Item 36. The system according to Item 35. 36. The system of claim 35, wherein the energy transfer surface comprises an articulatable ablation electrode. 36. The system of claim 35, wherein the energy transfer surface comprises monopolar or bipolar radio frequency electrodes. 36. The system of claim 35, wherein the energy transfer surface comprises a plurality of needles. 48. The system of claim 47, wherein the plurality of needles are extendable from a contracted structure to an ablation structure. 36. The system of claim 35, further comprising an occlusion balloon that is expandable to an inflated shape that is sufficiently sized to occlude the vessel lumen. 36. The system of claim 35, further comprising a first articulatable tissue grasper positioned on a first support member extending distally from the barrier or membrane. And further comprising a second articulatable tissue grasper positioned on a second support member extending distally from the barrier or membrane, the second tissue grasper comprising the first tissue grasper. 51. The system of claim 50, wherein the system is articulatable independently. And further comprising a length of wire or suture that is slidably passed through the tissue grasper, the first end of the wire or suture being attached to the tissue imaging and treatment system, 51. The system of claim 50, wherein the second end of the suture is pulled from outside the patient's body. Positioning an open region of the barrier or membrane relative to or adjacent to the tissue region to be treated;
Replacing opaque body fluid with a translucent fluid from an open area defined by the barrier or membrane and the tissue area;
Visualizing the tissue region within the open region through the translucent fluid;
Cauterizing at least a portion of the tissue region within the open region;
A method for transvascularly treating a tissue region within a body lumen. 54. The method of claim 53, wherein positioning the barrier or membrane open area comprises advancing the barrier or membrane into the left atrium of the heart. 54. The method of claim 53, wherein positioning the barrier or membrane open area comprises deploying the barrier or membrane from a low profile delivery structure to an expanded deployment structure. 54. The method of claim 53, wherein positioning the barrier or membrane open region comprises stabilizing the position of the barrier or membrane relative to the tissue region. 54. The method of claim 53, wherein positioning a barrier or membrane open area comprises directing the indwelling catheter to the tissue area. 54. Replacing the opaque bodily fluid with a translucent fluid comprises injecting the translucent fluid into the open region through a fluid delivery lumen defined through the indwelling catheter. The method described in 1. Injecting the translucent fluid comprises pumping saline, plasma, water, or a perfluoro liquid into the open area such that blood is displaced therefrom. 58. The method according to 58. Replacing the opaque bodily fluid with a translucent fluid comprises the fluid within the open region via at least one transparent distal membrane disposed at least partially over the distal end of the barrier or membrane. 54. The method of claim 53, comprising the step of partially holding. 61. The method of claim 60, wherein partially retaining the fluid comprises allowing the fluid to leak through at least one opening defined through the distal membrane. 62. The method of claim 61, wherein cauterizing comprises cauterizing the tissue region through the at least one opening. 54. The method of claim 53, wherein visualizing the region of tissue comprises observing the tissue via an imaging element positioned off-axis relative to a longitudinal axis of the barrier or membrane. 54. The method of claim 53, wherein ablating comprises contacting the tissue region with an ablation probe that is advanced through the open region. 65. The method of claim 64, further comprising articulating the ablation probe within the open area. 54. The method of claim 53, wherein ablating comprises forming a linear or annular lesion on the tissue region. 54. The method of claim 53, further comprising occluding blood flow through a pulmonary vein via an occlusion balloon inflated in a pulmonary vein distal to the barrier or membrane prior to cauterization. Prior to replacing the opaque body fluid, the first and second tissue regions are temporarily suspended alternately so that the barrier or membrane is moved from the first position to the second position through the body lumen. 54. The method of claim 53, further comprising the step of mechanically engaging. 54. The method of claim 53, wherein ablating comprises advancing a plurality of ablation needles into the tissue region. 54. The method of claim 53, further comprising visually monitoring the tissue region for color changes while cauterizing as an indication of sufficient tissue ablation. 54. The method of claim 53, further comprising visually monitoring the tissue region for signs of endocardial disruption. 72. The method of claim 71, wherein if endocardial disruption is detected, the power of the ablation probe is adjusted or the ablation of the tissue region is stopped. 73. The method of claim 72, further comprising further visually inspecting the tissue region. 72. The method of claim 71, comprising a tissue debris released from the disruption in the barrier or membrane when an endocardial disruption occurs. 75. The method of claim 74, further comprising aspirating the tissue debris contained within the barrier or membrane proximally through the indwelling catheter. 54. The method of claim 53, further comprising retracting the tissue region within the open region at least partially into the barrier or membrane and creating a seal therebetween. 77. The method of claim 76, wherein cauterizing comprises cauterizing the sealed tissue region of the open region. 54. The method of claim 53, further comprising visually inspecting a lesion formed on the tissue region within the open region. 79. The method of claim 78, further comprising repositioning the barrier or membrane over a second tissue region to be treated. A method for treating a target tissue of a patient's heart, the target tissue being below an intracardiac heart tissue surface region in a ventricle,
Optically imaging the tissue surface area;
Cauterizing the target tissue;
Monitoring the tissue response to the ablation using the optical imaging while the heart is pumping blood;
A method comprising: During the formation of an ablation lesion, the optical imaging provides sufficient feedback to the system user so that the heart of the patient has an arrhythmia and the lesion suppresses the arrhythmia, and the energy transfer surface and the tissue 81. The method of claim 80, wherein the connection between the surface region is verified. The energy delivery surface comprises an electrode surface and the system user induces movement of the electrode surface in response to a loss of contact between the target tissue and the electrode surface during formation of the lesion 92. The method of claim 81, wherein the pathogenesis can be interrupted. The optical imaging feedback provided to the system user during formation of the lesion includes color changes along the tissue surface area, lesion formation induced deformation along the tissue surface area, and evaporation adjacent to the tissue surface area. 82. The method of claim 81, comprising: bubble formation adjacent to the tissue surface region, positioning of the energy transfer surface, movement of the energy transfer surface, and / or ablation debris. The optical imaging provides sufficient feedback to the system user such that the heart of the patient has an arrhythmia, the target tissue comprises an elongated lesion pattern, and the lesion pattern suppresses the propagation of the arrhythmia. 81. The method of claim 80, wherein proximity along the length of the lesion pattern is verified. The lesion pattern comprises a plurality of discontinuous ablation lesions formed sequentially in the target tissue, and an energy transfer surface from alignment with the first portion of the target tissue to the second portion of the target tissue 85. The method of claim 84, wherein the movement is performed using optical feedback from the tissue response along a first discontinuous lesion associated with the first region of the target tissue. The lesion pattern is formed by moving an energy transmission surface relative to the tissue surface region while transmitting energy from an energy transmission surface to the target tissue, the movement being along the length of the lesion pattern 85. The method of claim 84, wherein the method is performed using optical feedback about the progress of the tissue response. The optical imaging feedback provided to the system user during formation of the lesion includes color changes along the tissue surface area, lesion formation induced deformation along the tissue surface area, and evaporation adjacent to the tissue surface area. 85. The method of claim 84, comprising bubble formation adjacent to the tissue surface region, positioning of the energy transfer surface, movement of the energy transfer surface, and / or ablation debris. Suspending the ablation of the target tissue during the ablation in response to optical signs of potential tissue surface disruption, the ablation comprising an ablation debris embolization or a rupture along the tissue surface region 81. The method of claim 80, interrupted before. 82. The method of claim 81, further comprising cooling the imaged tissue surface region during the imaging and the ablation. 81. The method of claim 80, wherein the tissue surface region is imaged by locally replacing blood from the imaging volume within the ventricle. The translucent fluid comprises a transparent fluid, the ventricle pumps blood disposed around the imaging volume, and the transparent fluid is in contact with the tissue surface region. 90. The method according to 90. 92. The method of claim 91, wherein the transparent fluid flows along the tissue surface region to remove blood from between the energy transfer surface and the tissue surface region. 94. The method of claim 92, wherein the transparent fluid cools the tissue surface area. Introducing a barrier or membrane into the ventricle; expanding the barrier or membrane within the ventricle; and restricting blood entry from the ventricle into the imaging volume by the barrier or membrane during the imaging. 92. The method of claim 91, further comprising: The optical imaging is performed to image a plurality of anatomical landmarks, further comprising aligning the energy delivery surface to the target tissue in response to one or more images of the captured landmarks. 81. The method of claim 80, comprising. The anatomical landmark comprises a pulmonary vein, an entrance of the pulmonary vein, a left atrial septum, a left atrial appendage, a mitral valve, a tricuspid valve, a foveal fossa, and a right atrial appendage. Item 80. The method according to Item 80. A system for treating a target tissue of a patient's heart, wherein the target tissue is below an intracardiac heart tissue surface region in a ventricle,
An intracardiac catheter having a proximal end, a distal end, and at least one lumen;
An optical imaging element that can be advanced distally into the ventricle using the catheter;
An energy transfer surface that can be advanced distally into alignment with the tissue surface region for ablation of the target tissue using the catheter;
An imaging fluid flow path that can extend distally from a translucent fluid source through the catheter toward the tissue surface region, optically ablating the heart while pumping blood An extendable imaging fluid flow path that includes the optical imaging element and the alignment energy transfer surface so as to suppress the persistence of blood in the field of view of the imaging element.
A system comprising: An indwelling catheter defining at least one lumen therethrough;
A barrier or membrane protruding distally from the indwelling catheter and defining an open region therein, the open region being in fluid communication with the at least one lumen;
A visualization element disposed inside or along the barrier or membrane for visualizing tissue adjacent to the open area;
An ablation energy transfer surface that can be positioned along or inside the barrier or membrane;
During treatment by the ablation energy transmission surface, at least one sensor is configured to be positioned on or inside the tissue region to be treated by the ablation electrode so as to detect at least one physical parameter of the tissue region. At least one sensor;
A tissue imaging and treatment system comprising: 99. The system of claim 98, further comprising a delivery catheter through which the indwelling catheter is deliverable. 99. The system of claim 98, wherein the indwelling catheter is steerable. 101. The system of claim 100, wherein the indwelling catheter is steered by pulling at least one wire. 101. The system of claim 100, wherein the indwelling catheter is steered via computer control. 99. The system of claim 98, wherein the barrier or membrane comprises a flexible material. 99. The system of claim 98, wherein the barrier or membrane defines a contact edge for placement against a tissue surface. 99. The system of claim 98, wherein the barrier or membrane is configured to be reconfigured from a low profile delivery structure to an expanded deployment structure. 106. The system of claim 105, wherein the barrier or membrane is configured to self-expand into the expansion structure. 106. The system of claim 105, wherein the barrier or membrane comprises one or more support posts along the barrier or membrane. 99. The system of claim 98, wherein the barrier or membrane is conical. 99. The system of claim 98, wherein the visualization element comprises at least one optical fiber, CCD imager, or CMOS imager. 99. The system of claim 98, wherein the visualization element is disposed within a distal end of the indwelling catheter. 99. The system of claim 98, wherein the visualization element is articulatable off axis relative to the longitudinal axis of the indwelling catheter. 99. The system of claim 98, further comprising a fluid reservoir fluidly coupled to the barrier or membrane. 113. The system of claim 112, wherein the fluid comprises saline, plasma, water, or a perfluoro liquid. 99. The system of claim 98, wherein the barrier or membrane further comprises a distal membrane that extends over the open region such that the ablation electrode is disposed circumferentially over the distal membrane. 99. The barrier or membrane further comprises a distal membrane that extends partially over the open region such that the distal membrane defines an opening through which the ablation electrode can extend. The system described in. 99. The system of claim 98, wherein the ablation electrode is articulatable. 99. The system of claim 98, wherein the ablation electrode comprises a monopolar or bipolar radio frequency electrode. 99. The system of claim 98, wherein the at least one sensor is positioned on or inside the ablation electrode. 99. The system of claim 98, wherein the ablation electrode comprises at least one penetrating needle having the at least one sensor housed within a needle lumen. 120. The system of claim 119, further comprising an optical fiber positioned within the needle proximal to the sensor, comprising a layer of thermochromic dye disposed over the distal end of the needle. 120. The system of claim 119, wherein the needle further defines at least one pore or opening along the length of the needle. 122. The system of claim 121, wherein the pore or opening is in fluid communication with a fluid reservoir. 120. The system of claim 119, further comprising a catheter body, wherein the at least one sensor is located at a distal end of the catheter body. 124. The system of claim 123, further comprising a handle coupled to a proximal end of the catheter body. 129. The system of claim 124, wherein the handle comprises a position indicator that indicates the penetration depth of the needle into the tissue to be treated. 120. The system of claim 119, further comprising a temperature sensor positioned proximal to the needle and configured to be brought into contact with the tissue region to be treated. 120. The system of claim 119, wherein the ablation electrode is positioned proximal to a needle and configured to contact the tissue region to be treated. 99. The system of claim 98, wherein the at least one sensor comprises a temperature sensor for detecting the temperature of the tissue region during treatment. 129. The system of claim 128, wherein the temperature sensor is configured to detect subsurface tissue temperature. 129. The system of claim 128, further comprising at least one additional temperature sensor. 99. The system of claim 98, wherein the at least one sensor comprises an impedance sensor for detecting an impedance or change in impedance of the tissue region during treatment. 99. The system of claim 98, wherein the at least one sensor comprises a temperature sensor and an impedance sensor adjacent to each other for detecting temperature and impedance, respectively, of the tissue region during treatment. 99. The system of claim 98, wherein the at least one sensor is positioned on a flexible section. 99. The system of claim 98, further comprising an inflatable balloon positioned proximal to the at least one sensor. 99. The system of claim 98, wherein the energy transfer surface is configured to align with the tissue region when delivering energy to a target tissue below the surface of the tissue region. 99. The at least one sensor is configured to detect a first physical parameter of the tissue region that is indicative of a desired treatment depth of tissue below the surface of the tissue region. system. 137. The system of claim 136, wherein the at least one sensor is further configured to detect a second physical parameter indicative of ablation of the tissue underlying the surface. 137. The system of claim 136, wherein the detected first physical parameter indicates a transmural tissue depth from the surface. 138. The system of claim 138, wherein the second physical parameter detected is indicative of ablation through the transmural tissue depth. 140. The system of claim 139, wherein the indication of ablation indicates that the tissue is unable to transmit an arrhythmia signal. 139. The system of claim 138, wherein the first physical parameter comprises an impedance or change in impedance of the tissue region. 140. The system of claim 139, wherein the second physical parameter includes temperature or a change in temperature. 143. The system of claim 142, wherein the at least one sensor is configured to stop energy transfer from the energy transfer surface when the tissue temperature is between 50C and 90C. A needle catheter having a variable length;
A needle body having a penetrating tip that is linearly movable to project from the distal end of the catheter;
At least one sensor positioned on or inside the needle body for detecting at least one physical parameter of the tissue region to be cauterized;
A subsurface tissue investigation device comprising: An indwelling catheter through which the needle catheter is translatable;
A barrier or membrane protruding distally from the indwelling catheter and defining an open region therein, the open region being in fluid communication with the at least one lumen;
A visualization element disposed inside or along the barrier or membrane for visualizing tissue adjacent to the open area;
An ablation electrode positioned on the distal end of the catheter;
144. The apparatus of claim 144, further comprising: 144. The apparatus of claim 144, further comprising a handle assembly coupled to a proximal end of the needle catheter. 144. The apparatus of claim 144, wherein the needle body has a diameter of about 0.022 inches. 145. The apparatus of claim 144, wherein the needle body is movable to project beyond the distal end of the needle catheter to a length of up to 15mm. 145. The device of claim 144, further comprising an insulating layer or coating covering the outer surface of the needle body. 145. The apparatus of claim 144, wherein the needle body defines at least one pore or opening along an outer surface of the needle body. 161. The apparatus of claim 150, wherein the pore or opening is in fluid communication with a fluid reservoir. 144. The apparatus of claim 144, wherein the at least one sensor comprises a temperature and / or impedance sensor. 153. The apparatus of claim 152, further comprising at least one additional temperature and / or impedance sensor positioned on a distal end of the catheter. 144. The apparatus of claim 144, further comprising at least one additional sensor positioned along the needle body. 144. The apparatus of claim 144, further comprising an ablation electrode positioned on a distal end of the needle catheter. 144. The apparatus according to claim 144, wherein a distal portion of the needle body comprises an ablation catheter. 144. The apparatus of claim 144, wherein the needle body comprises a helical structure. 145. The apparatus of claim 144, further comprising a cooling probe movable to project from the distal end of the catheter adjacent to the needle body. 159. The apparatus of claim 158, wherein the cooling probe is movable to project beyond the needle catheter distal end to a length of up to 4 mm. 145. The apparatus of claim 144, wherein the needle body is configured to project radially from a side of the catheter. Replacing the opaque body fluid with a translucent fluid from a volume in fluid communication with the surface of the tissue region;
Visualizing the tissue region within an open region through the translucent fluid;
Monitoring at least one physical parameter of the tissue region within the open region using a sensor disposed on or within the tissue region;
Cauterizing at least a portion of the tissue region within the open region;
A method for transvascularly treating a tissue region within a body lumen. Positioning a barrier or membrane opening region projecting distally from the indwelling catheter relative to or adjacent to the tissue region to be treated prior to replacing the opaque body fluid 164. The method of claim 161, comprising. 163. The method of claim 162, wherein positioning the barrier or membrane open area comprises advancing the barrier or membrane into the left atrium of the heart. 166. The method of claim 162, wherein positioning the barrier or membrane open area comprises deploying the barrier or membrane from a low profile delivery structure to an expanded deployment structure. 163. The method of claim 162, wherein positioning the barrier or membrane open area comprises stabilizing the position of the barrier or membrane relative to the tissue. 163. The method of claim 162, wherein positioning the barrier or membrane open area comprises directing the indwelling catheter to the tissue area. 163. Replacing the opaque bodily fluid with a translucent fluid comprises injecting the translucent fluid into the open region through a fluid delivery lumen defined through the indwelling catheter. The method described in 1. Injecting the translucent fluid comprises pumping saline, plasma, water, or a perfluoro liquid into the open area such that blood is displaced therefrom. 167. The method according to 167. Replacing the opaque bodily fluid with a translucent fluid comprises transferring the fluid within the open region through at least one transparent distal membrane disposed at least partially over the distal end of the barrier or membrane. 164. The method of claim 161, comprising partially retaining. 169. The method of claim 169, wherein partially retaining the fluid comprises allowing the fluid to leak through at least one opening defined through the distal membrane. 171. The method of claim 170, wherein cauterizing comprises cauterizing the tissue region through the at least one opening. 163. The method of claim 161, wherein visualizing the region of tissue comprises observing the tissue via an imaging element positioned off-axis relative to a longitudinal axis of the barrier or membrane. 166. The method of claim 161, wherein ablating comprises contacting the tissue region with an ablation probe that is advanced through the open region. 178. The method of claim 173, further comprising articulating the ablation probe within the open area. 164. The method of claim 161, wherein ablating comprises forming a linear or annular lesion on the tissue region. 164. The method of claim 161, wherein the monitoring further comprises advancing a needle body having the sensor positioned on the needle at least partially into the tissue region. 177. The method of claim 176, further comprising monitoring tissue impedance with the sensor. 178. The method of claim 177, further comprising monitoring the impedance for a change in impedance value indicative of needle sinus penetration through the tissue region. 177. The method of claim 176, further comprising monitoring tissue temperature with the sensor. 177. The method of claim 176, further comprising monitoring a tissue temperature on a surface of the tissue region with a second sensor. 164. The method of claim 161, further comprising injecting saline into the tissue region surrounding the sensor prior to cauterization. 166. The method of claim 161, wherein ablating comprises actuating an ablation electrode disposed on the distal catheter end proximal to the sensor and positioned on the tissue region. 166. The method of claim 161, wherein ablating comprises actuating an ablation electrode disposed on a distal end of a needle body that is advanced into the tissue region. 164. The method of claim 161, further comprising cooling the subsurface region of tissue. 166. The method of claim 161, further comprising visually monitoring the tissue region for color changes while cauterizing as an indication of sufficient tissue ablation. 164. The method of claim 161, further comprising visually monitoring the tissue region for signs of endocardial collapse. 187. The method of claim 186, wherein if an endocardial disruption is detected, the power level is adjusted or the tissue region is ablated. 188. The method of claim 187, further comprising further visually inspecting the tissue region. 187. The method of claim 186, comprising a tissue debris released from the collapse in the barrier or membrane if an endocardial disruption occurs. 189. The method of claim 189, further comprising aspirating the tissue debris contained within the barrier or membrane proximally through the indwelling catheter. 164. The method of claim 161, further comprising visually inspecting a lesion formed on the tissue region within the open region. 164. The method of claim 161, further comprising repositioning the barrier or membrane over the second tissue region to be treated.

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