JP2023551755A - Heart valve treatment device removal method and device - Google Patents

Abstract

Retrieval catheters and methods of use for removing heart valve treatments such as leaflet clips or prosthetic leaflet chordae are described. The retrieval catheter may include a cutting element and a basket, a piercing element, a clamping mechanism, or a similar grasping device. The method includes delivering a catheter to the area of the heart valve treatment, then optionally manipulating the catheter and associated instruments to cut tissue, then removing the heart valve treatment and withdrawing the catheter. Including. [Selection diagram] Figure 110

Description

(Related application)
This application is related to U.S. Provisional Application No. 63,081,504, filed on September 22, 2020, entitled "Method and Apparatus for Securing and Tightening Valve Clips," entitled "Valve Leaflet Clip Removal (Snare Shaft Tip)" U.S. Provisional Application No. 63,144,399, filed on February 1, 2021, entitled “Clip Removal to Avoid Chordae Tangle,” and U.S. Provisional Application No. 63,144,399, filed on May 11, 2021, entitled “Clip Removal to Avoid Chordae Tangle.” No. 63,187,285 is claimed and incorporated herein by reference in its entirety.

The present disclosure relates to novel and advantageous transcatheter devices and methods for facilitating valve repair and/or replacement. More specifically, the devices and methods herein relate to the removal of treatments that interact with heart valve leaflets.

Heart valve disease can occur when a patient's valve leaflets fail to close completely, causing blood to flow backwards or abnormally. Referring to FIG. 1, regurgitation is particularly common in the mitral valve 20 where the anterior leaflet 22 of the mitral valve is unable to properly combine with the posterior leaflet 24. When the ventricles of the heart 10 contract, some blood returns from the left ventricle 14 to the left atrium 12 instead of to the aorta 11. Similar regurgitation may occur at the tricuspid valve 15, allowing blood to return from the right ventricle 13 to the right atrium 16.

A common treatment for valve regurgitation is the use of treatment devices that overlap or permanently connect the leaflets. This heart valve treatment hardware may be installed using surgical, transcatheter, or minimally invasive means. For example, the hardware or treatments targeted for removal include the MitraClip (Abbott Structural, Santa Clara, CA), the PASCAL device (Edwards Lifesciences, Irvine, CA), surgically placed sutures (e.g., Alfieri sutures), or similar heart valve therapy. Other heart valve treatments may result from techniques that involve the leaflets as part of the treatment target, where involvement of part or all of the leaflets requires resection. Other examples include chordal replacement techniques placed either transcatheterally or surgically to compensate for inadequate length, splitting, or misalignment of existing chordae tendineae. . For purposes of this application, the phrase "heart valve therapy" refers to the treatment of heart valves, such as leaflet clips, sutures, prosthetic chordae, or other devices or methods related to the treatment of heart valves and associated valve leaflets. Defined as any device and/or method used in therapeutic treatment.

FIG. 2 illustrates an exemplary transcatheter delivery procedure for a valve clip 40 (eg, MitraClip) to treat a mitral valve 20 that is regurgitating. Delivery catheter 41 is advanced through right atrium 16, through atrial septum 18, and into left atrium 12. As best shown in FIG. 3, the inner portion of catheter 41A, including valve clip 40, is advanced through mitral valve 20 and into left ventricle 14. In this example, the leaflet clip 40 has two outer arms 40A disposed below the leaflets 22, 24 and two inner arms 40B disposed perpendicularly between the two leaflets 22, 24. including. As seen in FIG. 3, the catheter 41 includes a control wire that allows the outer arm 40A to be closed against the inner arm 40B to pinch or engage the tissue of the valve leaflets. As shown in FIG. 4, barbs or similar structures on arm 40B help secure leaflet clip 40 within the tissue of leaflets 22, 24. Finally, as shown in FIG. 5, the catheter 41 is removed. As seen in the top view of FIG. 6, the leaflet clip 40 is typically placed near the center of the valve 20 to prevent the center from opening, with two smaller leaflet clips on either side of the clip 40. Form an opening. The smaller diameter of these openings typically allows for better sealing of the leaflets and prevents regurgitation.

It may be necessary to remove these structures to facilitate other valve treatments, such as when regurgitation that requires treatment recurs or persists. For example, valves may require annuloplasty or rings, chordae or cords, positioning devices, or placement of replacement valves, many of which , may not be available with previously performed heart valve therapy.

In some cases, these treatments require removal from one or more attachment points on the valve leaflets, but they do not need to be removed completely to facilitate other valve treatments, leaving structures within the heart. Leave it behind, but you can move it away from the area of interest and apply the desired treatment.

However, these heart valve treatments are typically removed by open heart surgery, which is particularly traumatic for the patient and carries a relatively high risk of complications. Therefore, what is needed is a less traumatic approach to eliminating heart valve therapy that lowers the risk of complications.

The present disclosure relates to systems and methods for removing heart valve treatments that have been used to position valve leaflets. This removal may occur if further treatment for the treatment of the valve disease is required (e.g., different repair methods, valve replacement), if the heart valve treatment has caused or is likely to cause harm to the patient ( (e.g., stenosis, infection), heart valve treatment is not considered clinically beneficial, or may be necessary if there is a general desire not to perform treatment.

The present disclosure relates to systems and methods for removing heart valve treatments used to position valve leaflets, the heart valve treatments using surgical, transcatheter, or minimally invasive means. It may have been set up. In at least one embodiment, the hardware or treatment targeted for removal includes a MitraClip (Abbott Structural, Santa Clara, CA), a PASCAL device (Edwards Lifesciences, Irvine, CA), a surgically placed suture (e.g. , Alfieri suture), or similar positioning devices and techniques. In at least one embodiment, such a positioning device that needs to be removed may be the result of a technique that involved the leaflets as part of the treatment target, where involvement of part or all of the leaflets precludes removal. I need. An example of such a device is a chordae replacement technique placed using either transcatheter techniques or surgery. In some cases, chordae or cords are ineffective due to inadequate length, splitting, misalignment, or defects in the artificial material.

The method of the invention includes a tool for cutting native valve tissue attached to a heart valve repair, with or without a capture tool, to remove the hardware to be removed while it is exposed from the human body. Hold. In at least one embodiment, the cutting method comprises an adjustable snare over the heart valve treatment, mechanically cutting the native tissue from the heart valve treatment, or an electrosurgical cutting device that rapidly increases the intracellular temperature to 100%. By using an RF electrosurgical device that heats the tissue to reach 0.degree. C., the intracellular contents are converted from liquid to gas, undergoing a large volumetric expansion and resulting in evaporation. In at least one embodiment, the capture tool is an adjustable basket, bag, or bin. This capture tool can be used to disconnect, release, compress, modify, or completely retrieve heart valve therapy from the human body.

In some embodiments, the method for removing previously placed heart valve therapy consists of a steerable catheter inserted into the patient using a transseptal, transatrial, or transventricular approach. The steerable catheter includes a delivery catheter that allows for the placement of tools to cut and capture heart valve therapy.

In some embodiments, capture of the heart valve therapy is performed by insertion and implantation of tools directly into, over, and/or around the heart valve therapy. In this approach, natural tissue is severed from the heart valve treatment by using electrosurgical cutting devices (RF electricity or similar devices) or similar energy or force delivered from within an implanted tool. A basket or bag to capture the heart valve therapy may not be necessary for removal of the target material. Thus, in at least one embodiment, the cutting tool is used alone without the need for a capture basket.

In at least one embodiment, the loop structure is pressed onto a fixation method created by a tissue bridge, chordae implant, or heart valve therapy. The loop structure can be used to cut either by electrical current or by mechanical means. The loop structure may be circular, oval, or multi-segmented and may completely or incompletely encapsulate the area for cutting and removal. The loop structure can be used to surround heart valve treatments and tissue for removal and subsequent exposure.

In at least one embodiment, the tool is used to extend heart valve therapy for removal. This expansion may be mechanical, electrical, pneumatic, hydraulic, or similar means to deploy or change the shape of the heart valve treatment for its removal.

The elements of the tool can be fixed to the heart valve treatment, reducing the risk of embolism. This fixation can be achieved with anchors that are linear, helical, barbed, or a combination of these approaches.

In at least one embodiment, a catheter, spacer, balloon, or other device can be used in combination with a removal device to manage blood flow or regurgitation after valve removal in heart valve therapy. This can be done quickly if the removed heart valve treatment and basket can be retracted through the steerable catheter, and the sealing device can then be delivered through the same delivery catheter.

Further embodiments of the present invention relate to valve clips or similar removal systems for heart valve therapy that may include a cutting and capture catheter and a snare catheter deployable from the same or separate delivery catheters. The snare catheter can be used to first grasp and pull the valve clip distally (eg, further into the left ventricle) to create tension or force on the valve leaflets. The cutting loop and basket of the cutting and capture catheter can then be placed on the valve clip such that the cutting loop is placed on the proximal or atrial side of the heart valve treatment. Finally, the cutting loop can be activated to disconnect the heart valve therapy device, and the clip can finally be captured in the basket and removed from the patient. This design allows the cutting loop to be pulled through the tissue and the capture basket to be closed around the heart valve therapy device while simultaneously cutting and supplementing the heart valve therapy.

The snare catheter may include a snare loop having a circular shape or an elliptical saddle shape forming an arcuate shape along each side. The snare loop may have multiple teeth, a friction coating, or be constructed of coiled wire. The snare catheter may include a distal tip with an opening in its side wall and features that create friction with the captured valve clip, such as a sharp edge, ridge, groove, or hook.

The snare catheter may include a handle configured to accommodate the snare loop within the snare catheter. The handle may include a mechanism to maintain constant tension on the clip and a mechanism to limit the force the user applies to the tightened snare. The handle may include a locking mechanism for locking the snare in a desired storage position.

The removal system may also include a guidewire passage through one or both of the cutting and capture catheter and the snare catheter. In embodiments, the guidewire passage may extend through the snare catheter and the cutting and capture catheter basket. The guidewire may extend lengthwise across the supplemental basket or within the tip and along the exterior surface of the basket.

The removal system includes a tendon configured to at least partially occlude the distal opening of the delivery catheter and provide a relatively smooth transition with fewer steep surfaces on which the chordae tendineae or other features of the valve may "catch." A cord dilator may also be included.

The cutting and capture catheter may include an expandable capture basket that expands from a longitudinally compressed configuration to a longitudinally expanded configuration when the valve clip is captured.

The removal system may also include a catheter configured to push against the valve clip from the atrial side of the valve to provide a counterforce. Therefore, the cutting loop of the cutting and capture catheter can be better placed between the atrial side of the valve clip and the valve leaflets. The catheter may be configured for contact only or may be configured to evenly engage or attach to the valve clip.

The removal system may include a snare catheter that includes a cutting element that is engageable with tissue surrounding the valve clip or other heart valve therapy to facilitate capture and removal.

While multiple embodiments are disclosed, further embodiments of the disclosure will be apparent to those skilled in the art from the following detailed description, which illustrates and describes exemplary embodiments of the invention. Probably. As will be appreciated, the various embodiments of this disclosure are capable of modification in various obvious aspects, all without departing from the spirit and scope of this disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive.

These and other aspects, features and advantages of which embodiments of the invention are possible will be apparent and apparent from the following description of embodiments of the invention.

FIG. 1 shows an anatomical diagram of the heart.

FIG. 2 shows a side view of a procedure for implanting a leaflet heart valve therapy device.

FIG. 3 shows a side view of a procedure for implanting a leaflet heart valve therapy device.

FIG. 4 shows a side view of a procedure for implanting a leaflet heart valve therapy device.

FIG. 5 shows a side view of a procedure for implanting a leaflet heart valve therapy device.

FIG. 6 shows a top view of a procedure for implanting a leaflet heart valve therapy device.

FIG. 7 shows a side view of a removal catheter according to the invention.

FIG. 8 shows a side view of a removal catheter according to the invention.

Figure 9 shows a side view of a removal catheter according to the invention.

FIG. 10 shows a side perspective view of a removal catheter according to the invention.

FIG. 11 shows a side view of a removal catheter according to the invention.

FIG. 12 shows a cross-sectional view of a removal catheter according to the invention.

FIG. 13 shows an exploded view of a removal catheter according to the invention.

FIG. 14 shows a perspective view of a cutting loop according to the invention.

FIG. 15 shows a perspective view of a cutting loop according to the invention.

FIG. 16 shows a perspective view of a cutting loop according to the invention.

FIG. 17 shows a perspective view of a cutting loop according to the invention.

FIG. 18 shows a perspective view of a cutting loop according to the invention.

FIG. 19 shows a perspective view of a cutting loop according to the invention.

FIG. 20 shows a top view of the cutting loop according to the invention.

FIG. 21 shows a top view of the cutting loop according to the invention.

FIG. 22 shows a perspective view of a cutting loop according to the invention.

FIG. 23 shows a cross-sectional view of a cutting loop according to the invention.

FIG. 24 shows a cross-sectional view of a cutting loop according to the invention.

FIG. 25 shows a cross-sectional view of a cutting loop according to the invention.

FIG. 26 shows a cross-sectional view of a cutting loop according to the invention.

FIG. 27 shows a cross-sectional view of a cutting loop according to the invention.

FIG. 28 shows a cross-sectional view of a cutting loop according to the invention.

FIG. 29 shows a cross-sectional view of a cutting loop according to the invention.

FIG. 30 shows a cross-sectional view of a cutting loop according to the invention.

Figure 31 shows a side view of a basket according to the invention.

Figure 32 shows a side view of a basket according to the invention.

FIG. 33 shows a side view of a removal catheter according to the invention.

FIG. 34 shows a side perspective view of a removal catheter according to the present invention.

FIG. 35 shows a side perspective view of a removal catheter according to the present invention.

FIG. 36 shows a side perspective view of a removal catheter according to the present invention.

FIG. 37 shows a side view of a removal catheter according to the present invention.

FIG. 37 shows a side view of a removal catheter according to the present invention.

Figure 39 shows a side view of a removal catheter according to the invention.

Figure 40 shows a side view of a basket according to the invention.

Figure 41 shows a side view of a basket according to the invention.

Figure 42 shows a side view of a basket according to the invention.

Figure 43 shows a side view of a basket according to the invention.

Figure 44 shows a side view of a handle according to the invention.

Figure 45 shows a side view of a handle according to the invention.

Figure 46 shows a side view of a removal catheter according to the present invention.

Figure 47 shows a side view of a removal catheter according to the present invention.

Figure 48 shows a side view of a removal catheter according to the present invention.

Figure 49 shows a side view of a removal catheter according to the invention.

Figure 50 shows a side view of a removal catheter according to the present invention.

Figure 51 shows a side view of a removal catheter according to the invention.

FIG. 52 shows a side view of a removal catheter according to the present invention.

FIG. 53 shows a side view of a removal catheter according to the present invention.

FIG. 54 shows a side view of a removal catheter and guide catheter according to the present invention.

FIG. 55 shows a side view of a removal catheter and guide catheter according to the present invention.

FIG. 56 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 57 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 58 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 59 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 60 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 61 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 62 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 63 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 64 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 65 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 66 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 67 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 68 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 69 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 70 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 71 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 72 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 73 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 74 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 75 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 76 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 77 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 78 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 79 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 80 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 81 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 82 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 83 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 84 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 85 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 86 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 87 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 88 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 89 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 90 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 91 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 92 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 93 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 94 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 95 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 96 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 97 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 98 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 99 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 100 shows a side view of an ablation catheter procedure according to the present invention.

FIG. 101 shows a perspective view of a removal catheter device according to the present invention.

FIG. 102 shows a perspective view of a removal catheter device according to the present invention.

FIG. 103 shows a perspective view of a removal catheter device according to the present invention.

FIG. 104 shows a perspective view of a removal catheter device according to the present invention.

FIG. 105 shows a perspective view of a removal catheter device according to the present invention.

FIG. 106 shows a perspective view of a removal catheter device according to the present invention.

FIG. 107 shows a perspective view of a cut example of the valve.

FIG. 108 shows a perspective view of a removal catheter device according to the present invention.

FIG. 109 shows a perspective view of a removal catheter device according to the present invention.

FIG. 110 is a diagram illustrating a snare and removal system according to the present invention. FIG. 111 is a diagram illustrating a snare and removal system according to the present invention.

FIG. 112 shows a basket tip according to the present invention. FIG. 113 shows a basket tip according to the present invention.

FIG. 114 is a diagram illustrating a snare loop according to the present invention. FIG. 115 is a diagram illustrating a snare loop according to the present invention.

FIG. 116 is a diagram illustrating a snare loop according to the present invention.

FIG. 117 is a diagram illustrating a snare loop according to the present invention.

FIG. 118 is a diagram illustrating a portion of a snare loop according to the present invention.

FIG. 119 is a diagram illustrating a portion of a snare loop according to the present invention.

FIG. 120 shows a snare catheter tip according to the present invention. FIG. 121 shows a snare catheter tip according to the present invention.

FIG. 122 shows a snare catheter tip according to the present invention.

FIG. 123 shows a snare catheter tip according to the present invention.

FIG. 124 shows a snare catheter tip according to the present invention.

FIG. 125 shows a handle for a snare catheter according to the present invention. FIG. 126 shows a handle for a snare catheter according to the present invention.

FIG. 127 is a diagram illustrating a method for supplementing and removing a valve clip according to the present invention. FIG. 128 is a diagram illustrating a method for supplementing and removing a valve clip according to the present invention. FIG. 129 is a diagram illustrating a method for supplementing and removing a valve clip according to the present invention. FIG. 130 is a diagram illustrating a method for supplementing and removing a valve clip according to the present invention.

FIG. 131 shows a removal system configured for access via a guidewire. FIG. 132 shows a removal system configured for access via a guidewire. FIG. 133 System is a removal system configured for access via a guidewire.

FIG. 134 is a diagram illustrating a chordae dilator according to the present invention. FIG. 135 is a diagram illustrating a chordae dilator according to the present invention. FIG. 136 is a diagram illustrating a chordae dilator according to the present invention. FIG. 137 shows a chordae dilator according to the present invention.

FIG. 138A shows a removal system with an alternative guidewire path.

FIG. 138B shows a removal system with an alternative guidewire path.

FIG. 139 shows a removal system with a pigtail wire at the distal end of the basket according to the present invention.

FIG. 140 shows a retractable basket according to the present invention. FIG. 141 shows a retractable basket according to the present invention.

FIG. 142 is a diagram illustrating a method of applying force to a valve clip according to the present invention.

FIG. 143A shows an alternative basket shape of the present invention.

FIG. 143B shows an alternative basket shape of the present invention.

FIG. 144 shows an alternative removal system of the present invention without a basket.

FIG. 145 illustrates an alternative removal system having a cutting element as part of the snare loop according to the present invention.

FIG. 146 illustrates an alternative removal system having a cutting element as part of the snare loop according to the present invention.

Hereinafter, specific embodiments of the present invention will be described with reference to the accompanying drawings. However, the present invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, the following embodiments may be readily understood by those skilled in the art. It is intended that the present disclosure be provided so that the scope of the invention will be comprehensively and completely understood. The terminology illustrated in the accompanying drawings and used in the detailed description of the embodiments is not intended to limit the invention. In the drawings, like numbers refer to like elements.

FIELD OF THE INVENTION The present invention generally relates to devices and methods for removing heart valve therapy devices via transcatheter procedures. While current methods for heart valve therapy device removal require open-heart surgery, the techniques and devices of the present invention utilize transcatheter devices and devices that are less invasive and can provide better patient outcomes. Use methods.

For purposes of this application, the phrase "heart valve therapy" refers to the treatment of heart valves, such as leaflet clips, sutures, prosthetic chordae, or other devices or methods related to the treatment of heart valves and associated valve leaflets. Defined as any device and/or method used in therapeutic treatment. Although particular embodiments may discuss or illustrate specific heart valve treatment devices or methods, such as heart valve leaflet clips, it is to be understood that use in any heart valve treatment is specifically contemplated. . Therefore, any of the embodiments discussed herein should not be limited to use only with heart valve leaflet clips.

1-13 illustrate various aspects of one embodiment of a removal catheter 100 for removing a leaflet heart valve treatment device, such as a valve clip 40 or similar heart valve treatment device, according to the present invention. Removal catheter 100 generally includes an expandable capture basket 102 and a cutting element or cutting loop 104 disposed near the top opening of basket 102 . As seen in FIGS. 7 and 8, the basket 102 is placed over the implanted valve clip 40, and the top of the basket 102 and cutting loop 104 connect the clip 40 and the atrial leaflets 22, 24. It is located between the valve leaflets 22 and 24. The top opening of the basket 102 is then closed or reduced and the cutting loop 104 is actuated to cut the leaflet tissue surrounding the valve clip 40 (e.g., applying radio frequency energy) to release the clip 40 from the valve 20. . Finally, the capture basket 102 containing the valve clip 40 is pulled back and removed from the patient. Further details and variations of removal catheter 100 are described below, followed by a discussion of exemplary approaches and removal methods for various heart valves (eg, mitral valve 20 or tricuspid valve 15).

As best shown in FIGS. 9-11, removal catheter 100 includes an internal control member 108 (best shown in FIG. 11) disposed within an outer tubular sheath 110. Internal control member 108 may be a solid wire or tube extending between the distal and proximal ends of sheath 110. The basket 102 and cutting loop 104 are arranged at a distance from the inner control member 108 such that when the inner control member 108 moves longitudinally or rotationally relative to the outer tubular sheath 110, the basket 102 and cutting loop 104 move as well. connected to the tip.

Referring to FIG. 11, in one embodiment, a plurality of loops 102A are placed around the circumference of the top opening of the basket 102, and a wire or tightening loop 106 is placed through the loops 102A. As best shown in FIG. 13, the tightening loop 106 is comprised of a looped wire (e.g., circular, oval, etc.) and an elongated straight section 106A that may be connected to the control member 108 via a connecting sleeve 112. can be configured. Connection sleeve 112 may be clamped, welded, adhesive/epoxy, or any combination thereof applied to secure sleeve 112 to control member 108 . Alternatively, the tightening loop 106 can be connected to the control member 108 only via welding or adhesive.

Cutting loop 104 can similarly be formed into a conventional loop shape (e.g., circular, oval, saddle-shaped, etc.) and includes an elongated straight section 104E that can also be connected to control member 108 via connecting sleeve 112. can be included. In this regard, as seen in the cross-sectional view of FIG. 12, both elongate straight sections 106A and 104E are disposed within coupling sleeve 112.

In one embodiment, cutting loop 104 cuts tissue when radio frequency energy is supplied to the cutting loop. In one example, an RF power source is connected to the proximal end of the control member 108 made of conductive metal, thus transmitting RF energy to its distal end and then to the attached cutting loop 104. To complete the RF energy circuit with cutting loop 104, a second RF electrode can be connected to an RF power source and can be attached to the patient at another location via an electrode pad (monopolar RF system). , a second electrode can be included elsewhere on the removal catheter 100 (a bipolar RF system), or a second insulated wire can be included on the control member 108 (a bipolar RF system).

It may be desirable to separate the RF energy circuit of cutting loop 104 from both tightening loop 106 and basket 102 to prevent damage to other tissue within the heart. This can be achieved by using electrical insulators as specific locations on the device. For example, as seen in the cross-sectional view of FIG. 12 and the exploded view of FIG. can be electrically isolated from the RF current of control member 108.

In other examples seen in FIGS. 14-30, the cutting loop 104 can have a different structure, shape, and electrical insulation such that the non-insulated portion 104B (i.e., the portion that cuts the leaflet tissue) This helps reduce the risk of contact with the clamping wire 106 or any part of the basket 102. For example, FIG. 14 shows the cutting loop 104 with the uninsulated portion 104B of the wire located on the opposite side of the elongated straight portion 104E and adjacent the insulated portion 104A on each side. In this example, the uninsulated portion 104B may extend around the entire circumference of the wire, as seen in FIG. 21, or may be exposed only along the inside of the loop 104, as seen in FIG.

The non-insulated portion 104B can include only a single area (eg, approximately 1-5 mm) where the underlying wire 104C is exposed, as seen in FIG. 14, or as seen in FIG. may include a plurality of discrete non-insulated portions 104B (eg, 2 to 10 portions 104B) of relatively short length (eg, about 1-5 mm).

In all cutting loop embodiments, the majority of the surface of cutting loop 104 is insulated. Cut loop insulation 104A is selectively removed (for wires with pre-existing insulation) to form non-insulated portion 104B, which removes the valve when in contact with tissue proximate to the heart valve treatment. Cutting loop conductive wire 104C can be exposed so that RF cutting energy can be contacted and delivered to the apical tissue bridge. Alternatively, insulator 104A can be added (e.g., by dipping, spraying, or similar techniques) and non-insulated portion 104B can be created by masking the intended area before applying the insulator. can.

It will be appreciated that the non-insulating portion 104B can be oriented in a number of ways, for example, on the inner/outer surface of the cutting loop 104 as well as on the bottom (ie, atrial) side of the loop 104.

The wire 104C underlying the cutting loop 104 may be constructed of a shape memory metal (eg, Nitinol) or a similar conductive metal (eg, stainless steel or copper). As seen in the cross-sectional views of FIGS. 23, 24, and 25, the underlying wire 104C can have a rectangular cross-section, a circular cross-section, a triangular cross-section, and a square cross-section, respectively.

Cutting loop 104 may be comprised of one or more wires, such as first wire 104C and second wire 104D. Both wires can be constructed from similar materials (eg, Nitinol, stainless steel, copper, silver, or similar materials), or each wire can be constructed from different materials. For example, one wire 104C may be constructed of a metal that conducts current better (e.g., stainless steel, silver or copper), while the other wire 104D retains its shape between compressed and expanded configurations. (for example, a shape memory metal such as Nitinol). Multiple wires may be electrically separated or insulated from each other or independently. Different cross-sectional shapes can also be used with the same or different materials, as seen in FIGS. 16-18 and 26-28.

In another example, cutting loop 104 can be constructed from a single wire that includes multiple strands of different wire materials. For example, FIGS. 19 and 29 illustrate a wire core 104D comprised of shape memory strands with a plurality of conductive strands 104C disposed circumferentially around the core 104D. In another example, FIG. 30 includes alternating shape memory strands 104D and conductive strands 104C. In this regard, different strands can provide both desirable current conduction and the ability to expand from a compressed configuration to a predetermined loop shape. The plurality of wires may be electrically separated or insulated from each other or independently. Both of these two cable examples can have from 2 to 49 or more strands inside.

The cutting loop can have a variety of different shapes, structures, and electrically insulating patterns to facilitate the removal of tissue around the clip 104, which may include, for example, additional length and/or a predetermined path. Or a geometric shape can be provided. FIG. 101 shows that each side 314, 315 of the loop is lowered downwardly (i.e., proximally toward catheter 100) and its free end 311 is lowered upwardly (i.e., distally away from catheter 100). An alternative example of a cutting loop 316 having a curved "saddle" or wavy shape is shown. Side portions 314 and 315 can be insulated, and intermediate portion 311 and end portions 312 and 313 can be insulated. Intermediate portion 311 contacts or engages tissue on one side of loop 316 while ends 312 and 313 contact or engage tissue on the other side. Sides 315 and 316 can be bent outward to increase the width of loop 316, bent inward to decrease the width of loop 316, or relatively straight to provide a uniform width of loop 316 ( That is, the shape can be maintained (circular or elliptical).

Cutting loop 316 can facilitate many different tissue engagement methods; for example, ends 312 and 313 can be electrically activated in unison while cutting loop 316 axial tension is applied to effectively cut the tissue in contact with these portions 312, 313 and partially release the leaflet clip 40. The free end 311 can then be activated to ablate tissue adjacent thereto and complete the resection of the leaflet clip 40 from the leaflet. Alternatively, all three parts 311, 312, 313 can be activated simultaneously. Axial tension on loop 316 can be applied before, during, or intermittently to control engagement of loop 316. Although this embodiment shows three uninsulated cutting regions or portions 311, 312, 313, any number of cutting elements (e.g., 1 to 100) may include the entire loop 316 as one continuous uninsulated cutting member. ) is possible.

Including additional length along sides 314 and 315 may accommodate other tissue structures present around leaflet clip 40. The additional length of sides 314 and 315 is also deformable such that when tensioned by elongated straight section 317, sides 314 and 315 straighten and extend loop 316 into a generally axial configuration. It is. During this tensioning and elongation, the axial distance between free end 311 and proximal ends 312, 313 increases, including a greater variety of both diameter and angle of approach to the clip. Such non-linear paths can also accomplish this and are therefore considered in this disclosure, but are not shown here for brevity.

FIG. 102 illustrates a delivery mechanism having a cutting loop 316 previously described and an outer tubular sheath 320 that is substantially similar to that of sheath 110 previously described. However, outer tubular sheath 320 further includes a sheath cut 321 located at and circumferentially at the distal end of sheath 320. This sheath cutting portion 321 may have a similar structure and characteristics to the previously described non-insulated portion of the previous cutting loop, and may similarly be electrically activated to facilitate further areas of tissue that can be cut. can do. This outer tubular sheath 320 can be used in combination with any of the other instruments disclosed and in a manner that most facilitates the leaflet clip removal procedure. Again, all non-insulated cuts 311, 312, 313 and 321 may be activated individually at separate times or all together at the same time.

FIG. 103 shows the embodiment of FIG. 102 in a heart valve tissue model 330 with chordae tendineae 13 and leaflet positioning clips 40. FIG. This figure shows an example of how devices 320 and 316 engage tissue on all sides of clip 40 in a manner that is positioned to sever the attached tissue structure from clip device 40.

Another exemplary embodiment of the cutting loop 350 can be seen in FIG. 104, in which each side loop portion 314, 315 is bent upwardly (i.e., in the distal direction) and its free end is bent downwardly. (i.e. in the proximal direction). Additionally, side loop portions 314, 315 are shown bent laterally outward to increase the width of loop 350. The loop 350 can have a variety of different insulating and non-insulating portions as described in FIGS. 101-103 (ie, several individual non-insulating portions or the entire loop is non-insulating).

105 and 106 illustrate another embodiment of a removal device 360, which is generally similar to removal device 100, but further includes a first cutting loop 104 and a second cutting loop 316. In some cases, it may be difficult for a physician to accurately visualize which tissue to cut in order to completely remove a cardiac treatment device. The two or more loops allow for a first series of cuts to the valve tissue, followed by one or more second cuts to completely remove cardiac therapy without requiring dramatic repositioning of the loops. (eg, by tightening the first cutting loop). In contrast, a single cutting loop may need to be moved, longitudinally repositioned, and/or rotated to completely cut the cardiac treatment.

In this example, the first cutting loop 104 has a somewhat larger diameter (e.g., similar to the opening of the basket 104), and the second cutting loop 316 is smaller than the first cutting loop 104 and is spaced apart from the basket 104. It has a diameter at a certain position. Accordingly, the second loop 316 can be placed against the leaflets and/or the chordae tendineae (e.g., cut 370A through the anterolateral chordae and cut 370B through the posteromedial chordae in FIG. 107), and the cut 311, 313, and 313 can be activated to make a first series of cuts to tissue. This first series of cuts may not cut all of the tissue, but it cuts the cut 104B of the first cutting loop 104 and then activates one or more second cuts. A cut can be made to completely remove remaining tissue from cardiac treatment device 40 (eg, along cut 370C on the atrial side of clip 40 in FIG. 107).

Although specific embodiments of cutting loops 104 and 316 are shown in FIGS. 105 and 106, any combination of loops described herein may be used in this manner. For example, FIG. 108 shows an embodiment 180 having two loops 316 of similar shape and configuration. Therefore, any of the loops may differ in the number and pattern of cuts, and these cuts may be activated all at the same time or at different times/patterns. In one example, both cutting loops 104 and 316 are connected to the same electrical circuit (eg, internal control member 108). Alternatively, each loop 104, 316 (or each set of cuts) may have its own electrical circuit (eg, an individual conductive wire) to allow independent operation from other cutting loops. Furthermore, three or four cutting loops may be used alternately. The cutting loops can all be connected to the same removal catheter, or one or more loops can be connected to other cutting loops and/or to separate catheters from the basket 104. In some embodiments, one or more cutting loops can be placed on the ventricular side of the valve and one or more cutting loops can be placed on the atrial side of the valve.

If the tightening loop 106 has an insulation coating throughout its length, the cutting loop 104 may be placed directly over and contacting the tightening loop 106. Cutting loop 104 may also be spaced longitudinally from tightening loop 106, such as between about 0 mm and about 15 mm.

Preferably, the internal control member 108 (best shown in FIGS. 11-13) has sufficient column strength to force the basket 102 and cutting loop 104 out of the outer tubular sheath 110 while advancing through the vasculature. is flexible enough to efficiently deliver RF energy from the proximal handle to the cutting loop, is insulated to prevent current leakage into the bloodstream, and is It has good torque response so that the user can rotate the basket and loop when deployed around it.

In a preferred embodiment, the internal control member 108 consists of an internal control stylet joined or welded to a more flexible internal control cable, which is then joined to the cutting loop conduction wire tail using a distal coupler. . In a preferred embodiment, the internal control stylet, internal control cable, cutting loop conducting wire, and distal coupler are of the same material (e.g., steel alloy) to provide a strong welded joint and efficient current delivery throughout. enable. The internal control cable can be a laser cut tube, twisted cable, twisted cable tube, coil, or a combination thereof. In another embodiment, an internal control cable can extend from the proximal handle to the cutting loop 104 without requiring an internal control stylet.

In other embodiments, internal control member 108 may be two separate wires, one connected to tightening loop 106 and the other connected to cutting loop 104. If both internal control members are placed in the same single lumen of outer tubular sheath 110, basket 102 is first advanced distally over the inner basket control member until basket constriction loop 106 is fully exposed. It can be expanded by letting The internal cutting loop control member can then be advanced distally to deploy the cutting loop 104. Each loop can be rotated, advanced, or pulled back by a respective control member. This gives the operator more freedom. The heart valve treatment may first be captured or surrounded by cutting loop 104, followed by basket tightening loop 106 and basket 102. The cutting loop 104 can then be closed over the leaflet tissue bridge by pulling back the internal cutting loop control member. Once the cutting loop is closed on the tissue bridge, one of two steps can be performed: 1) closing the basket tightening wire 104 and basket 102 by retracting the internal basket control member proximally; or 2) if the cutting loop 104 cannot reach the base of the heart valve treatment, RF cutting energy can be applied to cut one side of the device to reach the base of the clip 40 and then Basket 102 can be closed. Once both loops are properly closed over the tissue on the atrial side of the heart valve treatment, the inner cutting loop control member is energized with RF power as it is pulled proximally back into the outer delivery sheath 110. The internal cutting loop control member delivers cutting energy only to the cutting element via cutting loop 104.

The internal control members described above may alternatively be located within separate outer tubular sheaths or within separate lumens within the same sheath 110. The system can be designed such that each sheath can be placed in a separate orifice (ie, on opposite sides of the heart valve treatment). Once both loops capture heart valve therapy, the same steps as described above follow.

Preferably, the internal control stylet and the control member insulation covering the external surface of the internal control member are sufficiently flexible so as not to affect advancement of the delivery catheter through the valve orifice. It is also as lubricated as possible to minimize friction between the internal control member and the delivery catheter as the internal control member is pushed distally and deploys the basket and cutting loop within the left ventricle. It is desirable that there be. For example, the insulation may include a hydrophilic coating, a silicone coating, a Teflon-like coating, a polyolefin coating, a thermofoam or thermoset coating, or a fluoropolymer.

Returning to basket 102, the length and diameter of basket 102 may depend on the size of heart valve therapy device or clip 40. For example, basket 102 may have a length within a range of about 20 mm to about 50 mm and a diameter within a range of about 10 mm to 20 mm. Depending on the size of the leaflet clip 40 and the angle at which the basket 102 is expected to capture the clip 40, the diameter of the basket 102 may be adjusted accordingly. For example, the greater the angle of cut-off across the opening of the basket 102 relative to the top surface, the greater the diameter of the basket 102 must be. Stated another way, unless the basket 102 is expected to be substantially directly beneath the clip 40, the basket 102 should be expanded to a diameter much larger than the diameter of the clip 40.

In one embodiment seen in FIG. 31, basket 102 can be constructed from a plurality of braided wires. The wire can be constructed from a shape memory material and can be braided over a mandrel of the desired basket size and then heat set so that the braided shape returns to the expanded basket shape after being compressed. The wire can be constructed from a shape memory material, such as Nitinol, or a non-shape memory material, such as stainless steel. The wire may also have an insulating coating such as ETFE, polyimide, parylene, silicone, or similar materials. The advantage of woven baskets is that their behavior can be modified by changing the basket wire diameter, basket wire, and/or weave density (i.e., basket pore size) while keeping the basket diameter and length fixed. The ability to change performance. The design of the basket diameter and length is primarily determined by the size of the heart valve treatment that is to be removed. The size, spacing, and number of woven basket eyelets can also be adjusted and optimized. In one example, when expanded, the pores 102B of the basket 102 range from about 100 microns to about 4 mm in diameter.

The wire size is small enough to allow for easy folding and deployment from the delivery catheter during the procedure, but sufficient to open in the presence of valve chordae or other structures. It is preferably large enough to provide rigidity to the basket. Basket pore size can vary from woven basket to woven basket, depending on design intent. In general, the size of the pore should be smaller than either the length, width, or height of the heart valve treatment, so that it can be embolized through the basket after it is cut and freed. This is to avoid doing so. Weaving a basket with very small pores can help filter and capture any debris generated during the tissue cutting process.

One advantage of coating the metal basket is to ensure that the electrical energy is concentrated within the cutting element and not distributed throughout the metal structure of the basket and into the blood pool. A second advantage of the coating is that it can also reduce friction, thus facilitating capture of the heart valve therapy within the basket. If the basket is too rough or has too many edges within the basket, the heart valve therapy may not attempt to fit completely within the basket. A lubricious coating or smooth layer can be added to the interior surface of the acquisition basket to facilitate acquisition of heart valve therapy.

In another embodiment, seen in FIGS. 32, 33 and 34, the removal catheter 150 is made of silicone, PET, polyester, nylon, polypropylene, Kevlar, or the like which can be folded or pleated into a radially compressed shape. The basket 152 is made of a polymer, such as a material such as. Basket 152 includes a plurality of openings sized (e.g., about 100 microns to about 4 mm in diameter) to prevent passage of both leaflet clips 40 and other biological material that may be dislodged from the procedure. It can be formed by Basket 152 may be similar in size to basket 102 described above. The top opening of basket 152 may also include a plurality of loops or passageways 152B sized to allow passage of tightening loops 106 so that basket 152 can be closed during a procedure.

The structure of polymer basket 152 can be completed using braid, mesh, weave, knitting, or injection molding. The possibilities for basket shapes and material combinations are endless, and only a few will be described here. It is important to choose a polymeric material that has high heat resistance, low moisture absorption, and is durable enough to collapse into the outer sheath multiple times. Silicones tend to best meet these performance requirements. If the basket is made of silicone, it can be molded into the basket shape as a separate component or directly onto the loop structure. When making a basket from a flat silicone sheet, it can be cut into a designed pattern and sewn onto the loops into the desired shape.

Depending on the material selected, the size and spacing of pores 152A can be adjusted. Generally, the pore size may be smaller than either the length, width, or height of the heart valve treatment to avoid embolization through the basket after the heart valve treatment is cut. Using a basket with very small pores can help filter and capture debris generated during the tissue cutting process. By designing the basket with pores, blood can also flow through it. Minimizing the force exerted in pumping blood (ie, minimizing the "parachute effect") helps improve operator control of the basket. Polymer baskets can be made with or without eyelets. If there is an eyelet as shown, it should be slidably attached to the basket tightening loop. If there is no eyelet, it will be securely fixed in the basket tightening loop.

Since the polymer basket 152 does not conduct electrical current, other embodiments are possible in which the cutting loop 104 of the removal catheter 160 also acts as a tightening loop, as shown in FIGS. 35 and 36. The basket 152 can be attached directly to the insulated portion 104A of the cutting loop 104 (or alternatively, can form the insulated portion directly around the uninsulated wire), leaving the exposed uninsulated portion 104B to perform the leaflet cutting. Leave it open.

Similar "single loop" embodiments are possible with other shapes and materials. For example, FIG. 37 shows multiple polymer or woven filaments woven together to form a flexible basket shape and a relatively large opening (eg, about 0.5 mm to about 4 mm). FIG. 38 shows a plurality of polymer or fabric fibers woven into a fabric basket 164 having relatively small openings (eg, about 0.5 mm to about 4 mm). FIG. 39 shows the polymer sheets sewn together to form the basket 166. In any of these embodiments, the cutting loop 104 may be exposed so that the non-insulated portion 104B can cut the leaflets of the valve after being tightened.

In other embodiments, the basket can be constructed partially or entirely from a laser cut basket. For example, FIGS. 40 and 41 show a plurality of vertical laser cut ribs with eyelets arranged along their length so that a plurality of wires or polymer filaments can be braided or woven. Figures 42 and 43 show laser cut basket shapes made entirely of laser cut shape memory metal (eg, a tube or sheet of shape memory metal).

The advantage of laser-cut baskets is that their behavior/performance can be modified by changing the tube dimensions and/or cut pattern/density (i.e., basket pore size) while keeping the basket diameter and length fixed. be. The design of the basket diameter and length is primarily determined by the size of the heart valve treatment that is to be removed. The size, spacing, and number of laser cut eyelets can also be adjusted and optimized. The material used preferably has shape memory properties, such as Nitinol, allowing the laser cut portion of the tube to expand and shape. By using materials with shape memory, the basket can be repeatedly collapsed and returned to the same shape. The wire size is small enough to allow for easy folding and deployment from the delivery catheter during the procedure, but sufficient to open in the presence of valve chordae or other structures. It is preferably large enough to provide rigidity to the basket.

The pore size of the basket can be varied in the laser cut design by changing the cut pattern to achieve the desired result. For example, pore size can vary within a range of about 100 microns to about 4 mm. Generally, the pore size is greater than either the length, width, or height of the heart valve treatment to avoid embolization through the basket after the heart valve treatment has been cut free. Should be small. One of the unique advantages of laser cut baskets is that the pore size and spacing can vary throughout the length of the basket. For example, the proximal open side of the basket can have large pores with a certain pattern density. The pore size and pattern density can be smaller and denser towards the distal end of the basket.

Any of the basket embodiments described herein can further include an outer cover to help collect any debris or embolic material released during the procedure. Such an outer cover can include a solid or perforated polymer sheet, a woven fabric, a tubular shape formed from relatively small, finely woven metal wires, or similar materials. In one particular embodiment, the interior of the basket can have a non-conductive liner, film, or coating (eg, silicone) on its interior surface to help prevent electrical conduction with the cutting element 104.

In one embodiment, removal catheter 100 can include a proximal handle portion 170, as shown in FIGS. 44 and 45. Handle 170 includes an outer housing 172 and a sliding member 174 configured to slide within a longitudinal slot within housing 172. The housing 172 can be connected to the outer tubular sheath 110 while the sliding member 174 is connected to the internal control member 108 so that the user can adjust the position of the sliding member 174 with the thumb to respond. Longitudinal movement of internal control member 108, basket 102, and cutting loop 106 can be effected.

Optionally, the handle 170 can deliver an electrically neutral solution (e.g., a dextrose solution) to the area near the cutting loop, amplifying the tissue cutting effect and reducing the surrounding area to the blood pool. A fluid connection port 176 (eg, a Luer port) may also be included that communicates with the interior of the internal passageway of the outer tubular sheath 110 to minimize energy loss. The amount and timing of this fluid can be controlled by the physician (e.g., via a syringe) or via an electrically actuated pump mechanism based on the position of the cutting loop 106 (i.e., the cutting loop is placed outside the outer tubular sheath). (and is in good contact with the desired tissue 110).

As seen in FIG. 45, the handle 170 may include a locking mechanism 173 near the distal end of the housing 172 that locks the internal control member 108 in place relative to the outer tubular sheath 110. For example, locking mechanism 173 can include a handle 177 configured to rotate a cam member 178 surrounding the proximal end of internal control member 108. When handle 177 rotates member 178, cam member 178 forms an interference fit with the inside of housing 172 and locks control member 108 in its longitudinal position. When the handle 177 rotates the cam member 178 in the opposite direction, the interference fit between the cam member 178 and the housing 172 is released, allowing the internal control member to slide longitudinally within the handle 170. 108 is released.

FIG. 46 shows an embodiment of a removal catheter 100 having a current overflow hole 111 within the outer tubular sheath 110. This embodiment is most beneficial for embodiments with a single tightening and cutting loop and either a polymeric or minimally conductive basket 102. The distal end of the outer tubular sheath 110 is closed from the blood pool as the cutting element 104 and fixation basket 102 are retracted inside the outer tubular sheath 110 to begin cutting the leaflet tissue. If this occurs after the tissue has been cut, the electrical current being supplied to the cutting element 104 will no longer be transferred to the tissue or blood, but instead will transfer heat and/or electricity through the basket 102, damaging it. is possible. A current overflow hole 111 in the outer tubular sheath 110 can ensure that the cutting element 104 is always in contact with the blood pool even after the cutting is completed. In this way, current is chosen to flow through the blood to the opposite RF electrode attached elsewhere on the patient, as opposed to the basket.

Alternatively, wire 113 can be attached to internal control member 108 to ensure that the current path is always accompanied by a pool of blood, even after the cutting is complete. Preferably, the wire 113 is designed to be long enough to always protrude from the distal end of the outer tubular sheath 110 even when the basket 102 is completely collapsed inside the outer tubular sheath 110. It is also preferred to have a very small area of exposed metal at the very distal tip, with the remainder being insulated. Thus, once the cut is complete, the current chooses to flow through the lower resistance wire to the blood as opposed to flowing through the higher resistance basket 102 (eg, silicone).

48-53 show side views of removal catheter 100 with basket 102 deployed and clamped. In FIG. 48, basket 102, tightening loop 106, and cutting loop 104 are all positioned within outer tubular sheath 110. As seen in this figure, these components are radially compressed (while keeping them compressed within the outer tubular sheath) to a relatively small diameter to allow passage through the patient's blood vessels. (can pass through smaller orifices and even between multiple clips).

In FIG. 49, internal control member 108 is advanced distally (eg, via slide member 174) such that basket 102 exits outer tubular sheath 110 and begins to expand radially. This distal movement continues until both basket 102 and cutting loop 104 are deployed and fully expanded outside of sheath 110, as shown in FIG. 50.

51 and 52 show that the inner control wire 108 has been pulled back, which causes both the tightening loop 106 and the cutting wire 104 to be pulled back and radially closed. Typically, RF energy is activated during this time so that the cutting wire 104 cuts tissue of the leaflets as it closes. When the cutting loop 104 is fully pulled inside the outer tubular sheath 110, the RF current is deactivated. This can be achieved in several different ways. For example, the aforementioned sliding member 174 of handle 170 can include a position switch that turns RF energy on and off at predetermined longitudinal positions. Alternatively, a manual on/off switch can be included on the handle 170 or on the RF power source.

A radiopaque marker may be placed at the distal end of the outer tubular sheath 110 to assist in determining when to manually turn off the RF energy. When doctors perform a tissue bridge cut, they look at a fluoroscopic screen. Since tissue is typically not visible under fluoroscopy, it may be useful to provide the operator with a visual indicator on the catheter 100 that the tissue bridge has been severed. The internal control member 108 and cutting loop 104 are pulled back into the sheath 110 during the cutting process, and the radiopaque marker is inserted into the sheath 110 so that the operator can fluoroscopically inspect the entire cutting loop 104 proximal to the radiopaque marker. When viewed, the tissue bridge is arranged so that it is cut. This is not only a useful visual indicator for the operator, but also makes the procedure safer. Once the cutting loop 104 passes the radiopaque marker, the RF cutting energy can be immediately terminated by the operator to prevent unintentional heating by applying power for longer than necessary.

Finally, the opening of the basket 102 is substantially fully tightened closed, and the position of the internal control member 108 may optionally be locked in place (eg, by a locking mechanism 173 on the handle 170). The basket 102 is maintained outside the outer tubular sheath 110 and drawn into the larger guide catheter used during the procedure.

The present invention includes different methods or approaches for removing heart valve treatments such as valve clips 40. For example, FIGS. 56-61 illustrate a removal procedure that traverses the atrial septum 18 and accesses the mitral valve 20. Although exemplary access methods and procedures have been described, it should be understood that variations are possible based on known catheter access techniques. Additionally, these access techniques may be used with any embodiment herein.

The mitral valve access procedure of FIGS. 56-61 may, in one embodiment, include an internal control member 108, an outer tubular sheath 110, an inner steerable catheter 180, and an outer transseptal guide catheter 182, which include: They can be seen separately in FIG. 54 and together in FIG. 55, and are discussed further below. Three nested, but independently curved, axially articulated catheters place the removal device anywhere within the heart, regardless of size or procedural location. make it possible. However, other tools, sheaths, catheters, and similar devices may alternatively be used to direct removal catheter 100, as described below.

Referring first to FIG. 56, the left atrium 12 is accessed by advancing a transseptal guidewire or needle into the atrial septum 18 (e.g., via the inferior vena cava 17 or superior vena cava 19) and using the guidewire. Access can be gained by crossing the atrial septum 18 and finally moving the guidewire into the left atrium. A relatively large diameter lateral transseptal guide catheter 182 may then be advanced over the guidewire and through the atrial septum 18 such that its distal end is located in the left atrium 12 . Alternatively, transseptal guide catheter 182 may be advanced through atrial septum 18 without the use of a transseptal guidewire. The lateral transseptal guide catheter 182 can optionally have a predetermined curve or curvature to help slope it from the inferior vena cava 17 toward the atrial septum 18.

The guidewire may be removed and the inner steerable guide catheter 180 may then be advanced through the outer transseptal guide catheter 182 such that its distal end is located within the left atrium 12. The distal end of inner steerable guide catheter 180 may be “steered” or deflected such that its distal opening is directed to a desired location on mitral valve 20. Because the guide catheter is independent of the outer transseptal guide catheter 182, the clinician can direct the inner steerable guide catheter 180 to any location along the mitral valve 20, and the outer transseptal guide catheter While keeping 182 in the same position, it can be rotated, advanced/retracted, or the degree of deflection can be changed.

In the example of a mitral valve 20 having a leaflet clip 40, the inner steerable guide catheter 180 is preferably oriented toward either of the two valve openings on each side of the central clip 40 (see top view of FIG. (see diagram). Once directed to the desired target location, the removal catheter 100 is threaded through the inner steerable guide catheter 180 from its distal end into the left atrium 12 to the side of the mitral valve 20, as shown in FIG. It is advanced into the left ventricle 14 through one of the openings.

As seen in FIGS. 57 and 58, the internal control member 108 is advanced distally through the outer tubular sheath 110 of the removal catheter 100, and the capture basket 102, tightening loop 106, and cutting loop 104 are moved distally through the outer tubular sheath 110 of the removal catheter 100. It is advanced from the sheath 110. Preferably, the capture basket 102, tightening loop 106, and cutting loop 104 are expanded such that the opening of the basket 102 and the opening of the cutting loop 104 face toward or point toward the leaflet clip 40. Connected to internal control member 108. For example, the plane 103A of the opening of the basket 102 and the opening of the cutting loop 104 may be at an angle 103C between 45 degrees and 135 degrees with respect to the axis 103B of the internal control member 108 (eg, 90 degrees). The internal control member 108 can rotate relative to the outer tubular sheath 110 (or alternatively can rotate the total removal catheter 100) to rotate the capture basket 102, tightening loop 106, and cutting loop 104 into the left ventricle 14. It can also be rotated inside. In this manner, the physician can position or orient the basket 102 in the desired position directly beneath the leaflet clip 40.

When the capture basket 102, tightening loop 106, and cutting loop 104 are deployed, the internal control member 108 (or alternatively The outer tubular sheath 110) can be pulled back proximally. Preferably, both the cutting loop 104 and the tightening loop 106 are positioned above the leaflet clip 40. That is, it is located between the leaflet clip 40 and the bottom abutment surfaces of the leaflets 22 and 24.

Referring to FIG. 60, internal control member 108 has been pulled back proximally to cause tightening loop 106 and cutting loop 104 to be partially pulled back. This closes the top opening of the basket 102 above the leaflet clip 40 and reduces the diameter of the cutting loop 104, which is located between the atrial portions of the leaflets 22, 24 and the leaflet clip 40. engage with.

As seen in FIG. 61, RF energy is applied to cutting loop 104 as it is pulled back proximally and its diameter decreases. The non-insulating portion 104B presses against the portions of the leaflets 22, 24 closest to the leaflet clip 40, thereby cutting this tissue and releasing the leaflet clip 40 from the mitral valve 20. RF energy is turned off to the cutting loop 104. Preferably, the outer transseptal guide catheter 182 has a diameter sufficient to accommodate the basket 102 containing the leaflet clips 40 therein. However, removal catheter 100, inner steerable catheter 180, and outer transseptal guide catheter 182 can all be withdrawn from the patient as a single unit if desired.

Additionally, it is contemplated that a prosthetic valve may be placed in place of the mitral valve 20 after the leaflet clip 40 is removed. If a guidewire is used during the removal procedure, it can also be used to advance and orient the valve delivery catheter to deliver and implant the prosthetic valve. An example of such a prosthetic valve replacement is described in US Pat. No. 8,579,964, entitled Transcatheter Mitral Valve Prosthesis, the contents of which are incorporated herein by reference.

Additionally, after leaflet clips are removed, blood flow management devices, such as spacers, catheters, balloons, or other devices, are used to manage blood flow across the valve until such time as additional therapy, such as a replacement valve, can be delivered. It is contemplated that the valve may be located at the valve location and expanded at the valve location.

62-65 illustrate another method of removing a leaflet positioning device, such as leaflet clip 40, through a transapical approach. First, as shown in FIG. 62, an incision is made in the sternum (eg, between the manubrium and the sternum), and the transapical sheath 184 is advanced through the incision through the top of the heart 10 and into the left ventricle 14. Removal catheter 100 is then advanced through transapical sheath 184 such that the distal end of outer tubular sheath 110 extends into left ventricle 14 .

Referring to FIG. 63, internal control member 108 is advanced distally within outer tubular sheath 110 to release and expand basket 102 and cutting loop 104 into left ventricle 14. The tightening loop 106 and the cutting loop 104 preferably have a predetermined curvature (eg, a heat set curve/curve) that directs the top opening of the basket 102 and the opening of the cutting loop 104 toward the leaflet clip 40. For example, the plane of the top opening of the basket 102 and the opening of the cutting loop 104 can be within a range of 135 degrees to 225 degrees (eg, about 180 degrees) relative to the axis of the internal control member 108. Internal control member 108 can be further rotated by the physician (or the entire removal catheter 100 can be rotated) to optimally align cutting loop 104 and basket 102 with leaflet clip 40.

As seen in FIG. 64, outer tubular sheath 110 is further advanced from transapical sheath 184 such that leaflet clip 40 is fully positioned within basket 102. As seen in FIG. 65, internal control member 108 is pulled back proximally to reduce the diameter of tightening loop 106 and cutting loop 104. As the diameters of loops 104 and 106 are reduced, the top opening of basket 102 is reduced, trapping leaflet clip 40 therein. Further, as the cutting loop 104 is reduced, RF energy is activated and delivered to the loop 104, allowing the non-insulated portion 104B to cut the leaflet tissue directly above the leaflet clip 40.

Preferably, the capture basket 102, tightening loop 106, and cutting loop 104 are expanded such that the opening of the basket 102 and the opening of the cutting loop 104 face toward or point toward the leaflet clip 40. Connected to internal control member 108. For example, the plane 103A of the opening of the basket 102 and the opening of the cutting loop 104 may be at an angle 103C between 25 degrees and 135 degrees with respect to the axis 103B of the internal control member 108 (eg, 90 degrees).

If the transapical sheath 184 has a sufficiently large diameter, the outer tubular sheath 110 can be retracted proximally and the basket 102 containing the leaflet clips 40 is withdrawn into the passageway of the transapical sheath 184 for removal. . If basket 102 and leaflet clip 40 are very large relative to transapical sheath 184, both sheath 184 and removal catheter 100 can be withdrawn at the same time.

66 and 67 illustrate another method of removing a heart valve therapy, such as a leaflet clip 40, via a trans-aortic approach. Referring to FIG. 66, an aortic guide catheter 186 is first placed within the aorta 11 and advanced into the left ventricle 14. Aortic guide catheter 186 may have a fixed curve/shape that helps the physician direct the distal end of catheter 186 under leaflet clip 40. Alternatively or additionally, aortic guide catheter 186 may include a steerable mechanism that allows deflection in different directions.

Removal catheter 100 is then advanced through aortic guide catheter 186 such that the distal end of outer tubular sheath 110 extends from the distal end of catheter 186 into left ventricle 14 . Internal control member 108 is advanced further distally relative to outer tubular sheath 110 such that basket 102 and cutting loop 104 are deployed, expanded, and positioned within left ventricle 14 . The openings in the basket 102 and the cutting loop 104 are co-located or oriented opposite the leaflet clip 40. For example, the planes of the basket 102 opening and the cutting loop 104 opening can be within about 300 degrees and 45 degrees (eg, about 320 degrees) relative to the axis of the internal control member 108.

Referring to FIG. 67, aortic guide catheter 186 is moved or (in the case of a steerable catheter) deflected such that cutting loop 104 and basket 102 are positioned over leaflet clip 40. Internal control member 108 is pulled back proximally inside 110, thereby reducing the diameters of tightening loop 106 and cutting loop 104 and closing the top opening of basket 102. As the diameter of the cutting loop 104 decreases, RF energy is delivered to the loop 104, allowing the non-insulated portion 104 to cut the region of leaflet tissue adjacent the leaflet clip 40, thereby cutting the leaflet clip 40. Release from mitral valve 20. Basket 102 and leaflet clip 40 can be pulled back through aortic guide catheter 186, or all catheters can be removed simultaneously as a single unit.

The present invention also contemplates the use of removal catheter 100 (or any variation described herein) over the tricuspid valve 15, as seen in FIGS. 68 and 69. Referring first to FIG. 68, a lateral tricuspid guide catheter 188 is first delivered to the right atrium 16 by either an approach through the inferior vena cava 17 or the superior vena cava 19. The tricuspid guide catheter 188 may include a fixed curve at its distal end to assist in its distal opening toward the tricuspid valve 15, or may include a manipulation mechanism to do so. I can do it. The inner intermediate catheter 189 can then be advanced through the outer tricuspid guide catheter 188 to provide a better angle towards the tricuspid valve 15. For example, the inner intermediate catheter 189 may have a fixed curve toward the tricuspid valve 15 or may have a fixed curve toward the tricuspid valve 15 to allow the physician to deflect the distal end of the catheter 189 toward the tricuspid valve 15. It may include a steerable catheter mechanism.

Removal catheter 100 is then advanced through internal intermediate catheter 189 such that it exits the distal end of internal intermediate catheter 189, enters right atrium 16, passes through tricuspid valve 15, and enters right ventricle 13. . The leaflet clip 40 is typically placed centrally on the valve 15 (e.g., similar to the top view of the mitral valve in FIG. 6) and forms the valve opening laterally, so that the removal catheter 100 Preferably, one is placed on each side of the leaflet clip 40.

Internal control member 108 is advanced further distally relative to outer tubular sheath 110 such that basket 102 and cutting loop 104 are deployed, expanded, and positioned within right ventricle 13 . The openings in the basket 102 and the cutting loop 104 are co-located or oriented opposite the leaflet clip 40. For example, the plane 103A of the opening of the basket 102 and the opening of the cutting loop 104 forms an angle 103C with respect to the axis 103B of the internal control member 108 within a range of about 0 degrees to 90 degrees (e.g., about 45 degrees). can do. Removal catheter 100 is pulled back proximally relative to inner intermediate catheter 189 so that cutting loop 104 and basket 102 are positioned above and outside leaflet clip 40 .

Internal control member 108 is pulled back proximally, thereby reducing the diameters of tightening loop 106 and cutting loop 104 and closing the top opening of basket 102. As the diameter of the cutting loop 104 decreases, RF energy is delivered to the loop 104, allowing the non-insulated portion 104 to cut the region of leaflet tissue adjacent the leaflet clip 40, thereby cutting the leaflet clip 40. Release from tricuspid valve 15. The basket 102 and leaflet clip 40 can be pulled back through the inner intermediate catheter 189, or all catheters can be removed simultaneously as a single unit.

It should be understood that any of the embodiments herein can be used in accordance with the access and delivery methods described in this application. Additionally, additional methods can be used in conjunction with these access and delivery methods, such as delivery and implantation of prosthetic valves (either mitral or tricuspid).

Although the embodiments of the removal catheter described above may include a basket or similar device to capture the heart valve treatment, such as a leaflet clip 40, different capture approaches and devices are also contemplated.

70-72 illustrate a removal catheter 200 for removing a heart valve treatment leaflet clip 40. FIG. Removal catheter 200 includes an elongate piercing member 202 that pierces the device and an outer cutting catheter 204 disposed over the piercing member 202. The elongate piercing member 202 is initially engaged or captured by the leaflet clip 40 by pushing the elongate piercing member 202 onto the top of the leaflet clip 40 (and optionally rotating or expanding it), as shown in FIG. It may be a wire, catheter, or similar elongated device with a pointed, helical-shaped distal end, expandable barbs, or rotating elements.

As seen in FIG. 71, outer cutting catheter 204 is advanced distally over elongate piercing member 202 until its distal end contacts the upper surface of the valve leaflets, as seen in FIG. External cutting catheter 204 can be configured to cut leaflet tissue with a variety of different mechanisms, such as mechanical (e.g., rotational or forward pressure) and/or electrosurgical cutting devices (i.e., electrical or cryo). I can do it. Once released from the leaflet tissue, the leaflet clip 40 may be removed by the elongated piercing member 202, as shown in FIG.

73-75 show a removal catheter 210 similar to catheter 200 previously described, but cutting catheter 212 also includes a grasping mechanism having two jointed jaw members connected via a joint (Figs. 76). After the elongated piercing member 202 engages the leaflet clip 40 (FIG. 73), the outer cutting member 212 is advanced distally over the elongated piercing member 202 until it contacts the top surface of the leaflet (FIG. 74). . The articulating jaw member preferably includes a tissue cutting mechanism at its end, such as a blade or an electric/cryoelectrosurgical cutting device mechanism, for cutting the leaflet tissue surrounding the leaflet clip 40. enable. Finally, in FIG. 75, the jaw members of cutting catheter 212 approach each other to engage and grasp tissue clip 40.

77-82 show another embodiment of a removal catheter 220 that is embedded within a previously placed leaflet clip 40, followed by passage of a loop-based tool 224 that encloses, cuts, and removes the clip 40. show. In FIG. 77, loop-based removal catheter 220 includes a central push rod 227, side push rods 223, and an anchor mechanism 226 connected to pushable element 225. In FIG.

FIG. 78 shows an end view of a loop-based removal catheter 220 that can be circular, oval, multi-segmented, or a combination of these shapes and elements. Side rods 223 push pushable element 225 and central push rod 227 applies a force to anchor mechanism 226. In FIG. 79, the entire loop-based removal catheter 220 is collapsed for placement within a delivery catheter sheath 221. In FIG. 80, anchor mechanism 226 is advanced into heart valve treatment hardware (ie, leaflet clip 40) using central push rod 227 and pushable element 125. 78 and 79, the side pushrod 223 is then used to push the pushable element 225 to wrap the loop-based removal catheter 220 completely or partially around the leaflet clip 40. In FIGS. Cutting is performed mechanically or electrically, and the target tissue is then removed.

FIGS. 83-88 show a removal catheter 230 that is implanted into a previously placed heart valve treatment (eg, leaflet clip 40) and then passed by a tool that expands the leaflet clip 40, after which the hardware is removed. shows. In FIG. 83, steerable guide catheter 231 is used to position removal catheter 232, which includes expansion tool 234 for expanding leaflet clip 40. In FIG. Dilation tool 234 may have barbs, anchors, or implantation mechanisms to remove or grasp natural or foreign leaflets or tissue material from tissue clip 40. In Figure 84, anchor 235 is advanced and implanted. In FIG. 85, expansion tool 234 is advanced within leaflet clip 40. In FIG. In FIG. 86, expansion tool 235 is mechanically expanded to expand leaflet clip 40. In FIG. Expansion may be assisted by charging, heating, hydraulic means, rotation, internal or external ultrasound or energy. Cut tissue from leaflet clip 40. In Figure 89, dilation tool 235 is closed and removed away from the leaflets. FIG. 88 shows a similar approach using a balloon expandable element 129.

89 and 90 are cross-sectional views of a mitral valve 20 treated with a heart valve therapy that includes one or more chordae tendineae structures 50. Chordae structure 50 typically includes chordae or strands 52 connected to the valve leaflets and the left ventricle via anchors 54 . The chordae tendineae 52 may be secured to the ventricular side of the valve leaflet 24 (FIG. 89) or the atrial side of the valve leaflet 24 (FIG. 90). As further described in the embodiments below, a device similar to that used to remove leaflet clips 40 can be used to remove chordae structures 50.

FIGS. 91-92 illustrate a removal tool 240 for cutting and capturing previously placed heart valve treatments including chordae tendineae or chordae structures implanted in the valve leaflets. In FIG. 91, this procedure is performed using the previously described cutting catheter 212, which can open, close, energize, and remove hardware similar to the descriptions above for other heart valve treatments in FIGS. 73-76. be done.

In FIGS. 93-97, this procedure is performed through a loop-based tool 250 that encapsulates, cuts, and removes hardware, similar to the description above of FIGS. 77-82.

In FIGS. 98-100, this procedure is performed using a cutting catheter 260, similar to the description above for other heart valve treatments seen in FIGS. 70-72.

Additionally, a flow restriction device can be used to limit the flow rate during any of the procedures described herein. For example, FIG. 109 shows an embodiment of the removal catheter 100 of FIG. 60 with an additional flow restriction device 341. The flow restriction device 341 can be placed in the area of the valve 20 (e.g., through the valve 20) before, during, or after removal of the clip 40 to reduce blood flow to the patient by restricting blood flow. maintained within the valve area to manage flow. Flow restriction device 341 can be any flow restriction device known to those skilled in the art, such as, but not limited to, a balloon, a covered stent, or a catheter. Any or all of these embodiments are configured, or have the ability to expand, by themselves or in combination with a valve structure, to occupy a clinically relevant space to manage blood flow. has. Flow restriction device 341 can be introduced independently via delivery catheters 342 and 343, as shown here. Additionally, flow restriction device 341 may be integrated into a delivery mechanism such as inner steerable catheter 180. Alternatively, flow restriction device 341 may be other therapeutic delivery systems, such as, but not limited to, heart valves.

Maintaining good mechanical contact or force between the leaflet tissue and the cutting element (e.g., cutting wire 104) is particularly important when performing the cutting procedures herein, especially when using RF as the mechanism for performing the cutting. Can be useful when using energy. This contact and force can be important in ensuring that the electrodes of the cutting element/loop are not exposed to large amounts of blood.

When using a constant power generator, such as many commercially available RF energy generators, when the cutting element is approximately exposed to the patient's blood, the impedance is typically perceived by the generator to be low (e.g., 0-300 ohms). Ru. This low impedance may not provide sufficient voltage to cut tissue. In such situations, there are RF energy generators that increase the current to maintain a constant power level.

On the other hand, if the cutting element is pressed firmly against the patient's tissue and has little exposure to the patient's blood, the impedance is relatively high (e.g., greater than 300 ohms) or the generator has a higher resistance to current flow. Recognized. This higher resistance may cause the generator to increase its voltage output to maintain constant power. Once the voltage reaches a certain level, the tissue cutting process begins and continues as long as the cutting element remains in contact with the target tissue.

By exploiting this phenomenon, electrosurgery within the heart and patient's blood pool becomes possible. Accordingly, it may be useful in the present invention to provide a mechanism to create and/or assist in maintaining pressure or force between the cutting element and the target tissue.

In general, when considering removal of an implanted valve clip 40, it is helpful to consider several factors to ensure sufficient mechanical force between the cutting element and the target leaflet tissue. obtain. Specifically, 1) the length of the valve leaflet tissue inserted into the arm of the valve clip 40, 2) the chordae tendineae extending around the valve clip 40, and 3) the use of multiple valve clips 40, their spacing, and position. angle, etc.

Additionally, there are at least four different possible scenarios for valve clip removal. Specifically, when 1) tightening the cutting loop on the atrial side of the valve clip 40 without requiring additional "counterforce" against the clip 40 (as described in previous embodiments/methods herein); 2) if it becomes useful or necessary to apply a counterforce to the valve clip 40 to stretch the tissue and tighten the cutting loop on the atrial side of the valve clip 40; 3) 4) if a counterforce is useful or necessary and the cutting loop must first cut some of the leaflet tissue before being tightened on the atrial side of the valve clip 40; and 4) using a cutting snare. , substantially releasing the engaged tissue from the clip 40 to facilitate engagement of the cutting loop and basket.

In a first scenario, the cutting loop and basket are placed on the valve clip 40 and the cutting loop is positioned on the atrial side of the valve clip 40, as previously described herein. It may also be possible to tighten on the tissue bridge without the use of instruments. This approach has been previously described herein. Tightening the cutting loop in this manner forces the cutting element firmly against the tissue and moves across the tissue bridge as it is drawn into the delivery catheter.

In the second scenario, some method of pushing in and out of the valve clip 40 is provided when retracting or tightening the cutting loop. The cutting loop can be placed and tightened on the atrial side of the valve clip 40 because this counterforce assists in stretching the tissue into/toward the left ventricle 14 and away from the direction in which the cutting loop is pulled. can. If a relatively large length of leaflet tissue is inserted into the arm of the clip 40, if multiple clips 40 are implanted (especially when the clips 40 are closely spaced), if the leaflet is too pliable, the leaflet Application of this counterforce can be useful or even necessary if the tissue bridge is too stiff or if a relatively large tissue bridge has previously been created.

In the third scenario, a counterforce stabilizes the valve clip 40 and leaflet and helps draw the cutting loop firmly to the leaflet edge. Once firmly pressed against the leaflet tissue, an initial cut can be made by pulling the cutting loop to the atrial side of the valve clip 40, and then a final cut can be completed by tightening the cutting loop.

In a fourth scenario, removal of engaged tissue may be necessary to facilitate engagement of the snare and allow the snare to provide a counterforce that stabilizes the valve clip.

In the context of these scenarios, there are several embodiments and methods that can be utilized to create a counterforce away from the left atrium 12 and into/toward the left ventricle 14.

In one example, steerable catheter 180 for delivering the cutting and supplemental catheter may be used to push against valve leaflets 22 , 24 and valve clip 40 to create a counterforce toward left ventricle 14 . For example, the distal edge of the distal opening can be positioned against the leaflets and/or valve clip 40.

As seen in FIG. 142, in another example, a pusher catheter 470 can be used to push the valve clip 40 from the left atrial side of the valve clip 40 toward the left ventricle. An elongated standard or steerable catheter may be used, or the catheter 470 may be further provided with a dedicated distal end portion 472 to assist in pushing or engaging the valve clip 40. For example, distal end portion 472 may be selectively expandable (eg, a balloon or expandable mesh structure) that is expandable to better contact valve clip 40. Alternatively or additionally, distal end portion 472 may have a blunted distal end. Alternatively or additionally, the distal end portion 472 may be configured to mechanically contact the valve clip 40 or the leaflet tissue immediately adjacent the valve clip 40. For example, the devices and mechanisms shown in FIGS. 70-100 can be used to contact valve clip 40 and adjacent tissue.

In either of these configurations, the catheter 470 is pushed against the valve clip 40 from the left atrium 12 toward the left ventricle 14, and then the cutting loop is placed between the atrial side of the valve clip 40 and the leaflets 22, 24. be able to. Finally, a cutting loop (eg, any embodiment described herein) can be activated to cut the leaflet tissue.

In yet another example, the valve clip 40 can be retracted further into the left ventricle 14 from its position within the left ventricle 14 to create a counterforce and position the cutting loop to enable tissue cutting as described above. .

110 and 111 illustrate one embodiment of a removal system 400 that creates a counterforce by retracting the valve clip 40 into the left ventricle 14, which includes a cutting and capture catheter 403 and a separate snare catheter. 401 (or alternatively, a separate cutting catheter and a separate supplementary catheter). The snare catheter 401 can be used to first grasp the valve clip 40 and pull it further into the left ventricle 14, and the cutting and supplemental catheter 403 can be used to cut the valve leaflets 22, 24 and capture the valve clip 40. can be used to Note that this technique can also be used for other valves, such as the tricuspid valve.

Cutting and capture catheter 403 is generally similar to the embodiments described above and may include any of the variations described above in that regard. For example, cutting and capture catheter 403 may include a basket 102 and a cutting loop 404 connected to an elongate inner control member 108 that moves all components into and out of a tubular jacket or sheath 110.

As best seen in FIGS. 112 and 113, the basket 102 may include a basket tip 414 at its distal end. Basket tip 414 can serve one or more of the following purposes. First, the basket tip 414 can be connected to or accommodate the end of the wire constituting the basket 102 . In one example, the basket tip 414 includes a cylindrical wall with a plurality of openings 414B through which the wire ends pass, thereby preventing the wire ends from unraveling and injuring the patient. do. The ends of the wires may be knotted, welded, or secured within the basket tip 414. Alternatively, the wire end can be welded or fused with the basket tip 414 without the need for opening 414B. Basket 102 may be woven from a single wire, in which case there would be only two openings 414B. It may also be braided with multiple wires, in which case multiple openings 414B (eg, two for each wire) may be required.

Second, the basket tip 414 has an atraumatic distal end shape 414A that helps prevent tissue within the patient from being harmed by the basket tip 414. For example, atraumatic distal end shape 414A can be spherical, round, oval, or conical. This basket tip 414 may also be used with any other embodiments herein.

Returning to FIGS. 110 and 111, the cutting and capture catheter 403 further includes a cutting element or loop 404 that is constructed and usable similarly to the previous embodiments. However, the main cutting loop 404, like the cutting loop 350, has a saddle shape. That is, the cutting loop 404 has sides forming a valley shape that slopes or curves distally downwardly and then proximally upwardly. This shape is desirable because it allows loop 404 to maintain a desired cutting angle with respect to the remaining elements of catheter 403 as it is retracted proximally into outer sheath 110. For example, if the cutting loop 404 forms a right angle perpendicular to the inner control member 108, the angle of the loop 404 may tend downward as the right angle joint is retracted into the outer sheath 110. On the other hand, the curved or saddle shape helps maintain the end of the loop 404 in the desired vertical range as retraction occurs. This may be particularly useful when the electrode of the cutting loop 404 is located on the opposite side of the loop from the internal control member 108. This cutting loop 404 can also be used with any of the embodiments described herein.

Snare catheter 401 includes a snare loop 420 connected at or near the distal end of an internal control member 418 (similar to member 108) that moves longitudinally within an outer tubular jacket or sheath 416. This allows snare loop 420 to be moved in and out of sheath 416 by internal control member 418. Outer tubular sheath 416 may be open at the bottom, similar to sheath 110, and may include a tip member 422 having an opening in a side wall that extends into the interior lumen of sheath 416.

Optionally, the snare loop 420 may include a cutting element as described above (e.g., an RF electrode near the tip) to engage tissue surrounding the clip, at least partially cutting the tissue and cutting the valve. Supplementing and removing the clip 40 may be facilitated at an initial stage. Furthermore, amputation and supplementary procedures can be performed subsequently. At least partial removal of the engaged tissue is required at this initial stage to facilitate engagement of the snare loop 420 and to allow the snare loop 420 to provide a counterforce that stabilizes the valve clip 40. There are cases. For example, a channel or trough can be cut into the tissue surrounding the valve clip 40, which allows the snare loop 420 to more securely engage the valve clip 40. An example of such a configuration is shown in FIGS. 145 and 146 and includes an RF electrode 421 at the distal end of snare loop 420 in addition to RF electrode 405 at the distal end of cutting loop 404 . However, any type of cutting element may be used.

Snare loop 420 can have a variety of different shapes configured to grip valve clip 40. For example, FIGS. 114 and 115 show "saddle-shaped" or arc-shaped loops similar to cutting loop 404 (i.e., curve distally downward and then return upward to connect with each other to form an arc or concave shape). (side) is exemplified. The curved shape may prevent the distal end or tip of snare loop 420 from moving distally downwardly beyond the distal end of the distal end of snare catheter 401. In other words, when snare loop 420 is fully extended from catheter 401, its distal end angle is upward, so when loop 420 is retracted, its angle is distal downward. However, because the distal end is curved proximally, the distal angle of loop 420 will not be sufficient to disengage loop 420 from valve clip 40. Stated another way, loop 420 is curved proximally enough such that the distal end of the loop is not located distally beyond the distal end of snare catheter 401.

In another example shown in FIG. 116, the snare loop 424 may have a generally circular shape, optionally extending radially outwardly and recessed on the opposite side of the outer sheath 416. , or may have a curved section 424A. Although a single notch or recess 424A is illustrated, multiple sections 424A may be provided partially or entirely around the snare loop 424.

Snare loop 424 has a shape memory imparted to connect to internal control member 418 at approximately 90 degrees. In some cases, as the 90 degree bend is pulled into the snare catheter 401, the loop 424 may tilt or bend downward, potentially causing the loop 424 to become disengaged from the valve clip 40. On the other hand, the saddle-shaped snare loop 420 has a distal/downward arcuate curve, which helps maintain the original orientation of the loop 420 even when the loop 420 is retracted into the snare catheter 401, allowing the loop 420 to Better maintained on valve clip 40.

Snare loop 420 can further include features to provide a stronger grip on valve clip 40. For example, as seen in the snare loop 420 shown in FIGS. 114 and 115, a friction coating or sleeve can be placed over a portion or the entire snare loop. In another example, as seen in FIG. Can be placed throughout. In another example, the snare loop can be constructed from a wire coil, configured in either a compressed configuration 428A (FIG. 118) or a longitudinally expanded configuration 428B (FIG. 119). This allows for various levels of texture and enhances the grip of the loops on the valve clip 40. These different loop shapes and frictional engagements can be mixed and matched with each other and with any of the embodiments described herein.

Although snare catheter 401 and snare loop 420 are described above as being used to grip valve clip 40, other uses are possible. For example, it can also be used to image other tissues. It may be desirable to remove calcified nodules within the leaflets to facilitate valve placement. It may be used to capture and remove leaflet tissue to facilitate flow after replacement valve insertion. May be used to remove chordae tendineae to facilitate movement of the valve. In this regard, snare loop 420 can be used to grasp such tissue while cutting loop 404 cuts such tissue. However, it may also be useful to initially provide the snare loop 420 with a cutting element (eg, an RF electrode) to assist in cutting such tissue.

Snare catheter 401 may further include a tip member 422 at the distal end of outer tubular sheath 416, as best seen in FIGS. 120 and 121. Tip member 420 can be configured to maintain snare loop 420 at a desired angle or orientation relative to outer tubular sheath 416 and valve clip 40. Because the valve clip 40 tends to have a generally conical or "V" shape, as previously indicated herein, the tightening snare loop may have a tendency to squeeze out of the valve clip 40 when tightened. There is sex. This tendency to slip may be increased when snare loop 420 is positioned at an elevation angle relative to the vertical axis of valve clip 40. When snare loop 420 exits outer tubular member 416 through a distally facing opening (e.g., in the absence of tip member 422), the angle of snare loop 420 increases with respect to the axis as it is retracted into outer tubular sheath 416. , it may slip off the valve clip 40.

In contrast, the tip member 422 has an opening 422A extending through its sidewall and a snare loop 420 exiting the opening 422A at an angle generally perpendicular to the axis of the outer tubular sheath 416 and the axis of the valve clip 40. includes a sloped or curved surface 422B configured to guide.

Further, the tip member 422 can have features that assist in engagement and/or friction with the valve clip 40 such that the snare loop 420 tightens the valve clip 40 against the tip member 422 and the valve clip 40 It can be prevented from slipping off the loop 420. In the example of FIGS. 120 and 121, the shape of opening 422A may have relatively acute or steep corners around its periphery to help push it into valve clip 40 and maintain its position. Good too.

In the example of FIG. 122, a proximal channel 422C and a distal channel 422D extend from the main opening 422A, with additional channels having acute or sharp corners extending a longer distance in the longitudinal direction. can provide a wide range of areas. In the example of FIG. 123, tip member 422 can include a plurality of ridges or grooves 422E on a surface of tip member 422 adjacent opening 422A and/or channels 422C, 422D. These ridges or grooves 422E can be relatively straight and circumferentially oriented with respect to the openings 422A and/or channels 422C, 422D, or can have a different pattern, such as a wavy or zigzag pattern. You can also do it. In the example of FIG. 124, a plurality of spikes, hooks, or similar sharp features may extend from the sides or other proximate locations of the main opening 422A. Any combination of these engagement features can be used together to provide a surface that is better able to engage the valve clip 40 upon contact.

Snare catheter 401 may also include a handle 440 configured to controllably retract internal control member 418 and, in turn, snare loop 420. Specifically, the handle 440 allows a predetermined limited amount of force to be applied to the snare loop 420 while allowing the ability to lock the position or force of the snare loop 420 at a desired level. . This allows for a relatively firm grip on the valve clip 40 without requiring sufficient force to break the catheter 401, and allows this gripping force to be applied to the handle 440 for most of the procedure. It can be maintained throughout the procedure without holding the section.

Handle 440 may have other possible mechanisms to control and lock the position/force of snare loop 420. An example of such a mechanism is shown in FIGS. 125 and 126, which include an outer housing 442 that is generally cylindrically shaped and located at a proximal end of the housing 442 and extending proximally from the housing 442. It has a knob 448 configured to be pulled out to the side (ie, on the right side in the figure). Pulling knob 448 proximally also pulls internal control member 418 proximally, drawing snare loop 420 proximally into the opening in tip 422 .

The force exerted on knob 448 as it is withdrawn is limited or resisted by spring 450 disposed in housing 442. A spring 442 can be connected to either the internal control member 418 or the distal portion 440 of the knob 448 and inside the housing 442 such that when the knob 448 is pulled proximally, the spring 450 compresses or It can expand and generate stronger resistance. Depending on the configuration of spring 450 (e.g., size, initial compression, spring constant, and similar aspects), the force applied by spring 450 can be optimized to provide a predetermined amount of force over the length that knob 448 can be pulled. A constant tension can be applied, or the tension can be increased as the knob 448 is pulled further proximally.

Handle 440 may also include a locking mechanism that can lock the position of internal control member 418 relative to housing 442 and outer sheath 416. In the example shown in FIGS. 125 and 126, the locking mechanism includes a longitudinal groove 444 extending along at least a portion of the length of the housing 442. In the example shown in FIGS. Tracking peg 446 is secured to internal control member 418 and positioned at least partially within or through groove 444 . When knob 448 is pulled back proximally, tracking peg 446 moves along the length of groove 444. Once the internal control member 418 reaches the desired position, the knob 448 is rotated to move the tracking peg 446 transversely to the length of the groove 444 into one of the plurality of branch grooves. can be done. These bifurcated channels are preferably shaped to maintain the position of the tracking peg 446, and thus the internal control member 444, when the user releases the knob 448. For example, the bifurcation groove may be sloped somewhat distally such that the tracking peg 446 within the bifurcation groove is maintained by the distally directed force of the spring 450 and releasably locks the internal control member 418. I can do it.

The handle 440 also includes a port 452 that communicates with the inner and outer sheath 416 of the handle housing 442. This port 452 can be used to supply saline, contrast, or similar fluids during the procedure.

Handle 440 may also be electrically connected to an RF generator and snare loop 420 to provide energy to cutting snare 420 during the procedure (where the snare loop includes RF electrodes or similar cutting elements). case). As previously discussed, in some circumstances, snare loop 420 may be attached to at least a portion of the tissue surrounding valve clip 40 or other heart valve treatment devices to better engage snare loop 420 with valve clip 40. It may be useful to include a cutting element to cut.

It is generally desirable that the same delivery catheter (eg, steerable catheter 180) include and be routed through both the cutting and capture catheter 403 and the snare catheter 401. However, depending on the particular procedure, cutting and capture catheter 403 and snare catheter 401 may be delivered separately through separate delivery catheters or without the use of any overlying catheter.

127-130 illustrate an exemplary approach using a removal system 400 that includes a cutting and capture catheter 403 and a snare catheter 401. FIG. Although a specific removal system 401 is illustrated and described, variations in this procedure are also contemplated, including the use of different embodiments described herein.

First, a delivery catheter (eg, steerable delivery catheter 180), including cutting and capture catheter 403 and snare catheter 401, is delivered into the left atrium 12 of the patient's heart. Generally, it is desirable that the tip of the catheter 180 first be delivered through the valve leaflets 22, 24 and into the left ventricle 14. This may be useful in preventing either the cutting/supplementing catheter 403 or the snare catheter 401 from becoming entangled with any of the chordae tendineae extending from near the valve leaflets 22, 24. The basket tip 414 of the basket 102 may be positioned at, or partially beyond, the opening of the delivery catheter 180, thereby providing "capture" during passage through the valve leaflets 22, 24 or nearby chordae tendineae. ” or can be useful for creating a generally smooth surface that is free from snags.

Next, the cutting/supplementing catheter 403 and the snare catheter 401 are taken out from the catheter 180 and sent into the left ventricle 14. Initially, opening 422A of tip member 422 faces valve clip 40. If snare loop 420 has not yet been externally deployed, internal control member 418 is moved distally via handle 440 to cause deployment and expansion. After snare loop 420 is aligned with valve clip 40, snare catheter 401 is moved proximally so that snare loop 420 surrounds valve clip 40, as seen in FIG.

During this time, basket 102 and cutting loop 404 may be in either a different or opposite rotational position than snare loop 420 and/or disposed distally beyond snare loop 420.

Referring to FIG. 128, the snare loop 420 is tightened or tightened around the valve clip 40 until the valve clip 40 is pressed against the tip member 422. This can be accomplished by retracting the internal control member 418 proximally through the handle 440 (eg, by pulling back the knob 448 to lock its position within the slot 444). If not already aligned, cutting loop 404 and basket 102 are vertically aligned with both valve clip 40 and snare catheter 401.

As seen in FIG. 129, the snare catheter 401 is delivered distally to create a counterforce that draws the valve clip 40 further into the left ventricle 14. The cutting and capture catheter 403 is retracted proximally (at the same time or prior to the occurrence of a counterforce) so that the cutting loop 404 is removed from the atrial side of the valve clip 40, between the clip 40 and the valve leaflets 22, 24. placed between. Basket 102 is disposed partially or substantially completely around valve clip 40 and the distal portion of snare catheter 401 (eg, snare loop 420 and distal tip 422).

Referring to FIG. 130, while maintaining a counterforce from snare catheter 401, both tightening loop 106 and cutting loop 404 are tightened or contracted. As previously discussed, this opposing force allows for good contact between the electrodes of cutting loop 404 and the leaflet tissue. Thus, when the snare loop 404 electrode is activated, a quick, clean cut can be made through the tissue, and the valve clip 40 is completely removed and captured in the basket 102. Finally, cutting and capture catheter 403 and snare catheter 401 are at least partially pulled back into delivery catheter 180 and removed from the patient. When the cutting and capture catheter 403 and snare catheter 401 are retracted into the delivery catheter 180, the distal end/opening of the delivery catheter 180 may remain within the left atrium 12 and be pulled back into the left ventricle 14. You may be

In a scenario where the cutting and capture catheter 403 and the snare catheter 401 are retracted after the delivery catheter 180 is returned to the left ventricle 14, the chordae of the valve may become obstructed as the delivery catheter 180 returns to the left ventricle 14. be. For example, the distal end of delivery catheter 180 may not be sufficiently tapered and may "catch" the chordae tendineae.

One solution to this problem is to include a chorda tendine dilator that is partially positionable at the distal opening of the delivery catheter 180 as it passes through the valve leaflets 22, 24 and the chordae tendineae. Such chord dilators can have tapered and/or sloped distal surfaces and can be radially sized to include most or all of the opening of the delivery catheter 180. .

An example of a chordae dilator 432 can be best seen in FIGS. 134-137. In this embodiment, the chordae dilator 432 includes a body having a bottom surface 432D that has a bias angle (ie, an edge that forms an angle, such as about 45 degrees, with respect to the vertical axis of the dilator 432). Additionally, bottom surface 432D may be rounded or slightly conical to facilitate transition to delivery catheter 180. If desired, the chordae dilator 432 may have a top surface 432C having a similar shape, which is useful for diverting the chordae tendineae in both directions for either the mitral or tricuspid valves. It can be.

The chordae dilator 432 has two passageways 432A, 432B, one passageway 432A housing the snare catheter 401 and the other passageway 432B housing the cutting and supplementation catheter 403. Alternatively, the chordae dilator 432 may have only a single passageway that accommodates only one of the snare catheter 401 or the cutting and capture catheter 403. In either case, each catheter within the passageway is preferably rotatable while the procedure is being performed. Additionally, one of the passageways may have a "C" shape (ie, a shape that does not completely surround the catheter) so that one of the catheters can be separated from the chordae dilator 432. If desired, chordae dilator 432 may include one, two, or more radiopaque markers 432E. For example, radiopaque markers 432E may be disposed on circumferentially opposite sides of chordae dilator 432 and extend at least partially between the proximal and distal ends of chordae dilator 432. may exist.

If the user wishes to move the delivery catheter 180 into the left ventricle to supplement the snare catheter 401 and/or cutting and supplementation catheter 403, the snare catheter 401 and/or the cutting and supplementation catheter 403 may be moved to the left ventricle, similar to that shown in FIG. 403 is moved relative to delivery catheter 180 to place chordae dilator 432 partially into the distal opening of delivery catheter 180. Delivery catheter 180, snare catheter 401, and cutting and capture catheter 403 are then all advanced distally until the distal end of delivery catheter 180 is located within left ventricle 14.

Alternatively, the chordae dilator 432 may be configured only to connect to the snare catheter 401 and the cutting/supplementation catheter 403 without having a specific surface for chordae dilation. In this regard, the chordae dilator 432 need not be used in chordae dilation applications, but is primarily used to maintain the two catheters in parallel to achieve the desired alignment while the procedure is performed. It is useful for

Chordus dilator 432 may alternatively include three passages. For example, one passageway 432A houses snare catheter 401, another passageway 432B houses cutting and capture catheter 403, and another facilitates passage of a guidewire. The chordae dilator 432 can also be used to provide relative axial alignment of the snare, cutting loop, and basket. The position of the other members relative to the chordae dilator 432 changes the length of the free member arm, thereby controlling the distance between the members and the angle of the member axis.

Although snare catheter 401 is described above as being used to grasp valve clip 40, other uses are possible. For example, it can be used to grasp or capture a guidewire or Fogarty Balloon while a procedure is being performed (e.g., when a Transapical Approach is being performed) and can This is useful for withdrawing these components through valves that prevent them from becoming tangled or stuck.

Removal system 400 was previously described as being delivered through a Transeptal guide catheter 182 or similar catheter. However, the removal system 400 can be further configured to have a guidewire path or passageway so that it can be threaded over the guidewire 430. The guidewire can provide a more delicate force and stiffness transition to the tissue when providing the removal system, ensuring safe introduction into various anatomical structures. 131-133 illustrate an example of a removal system 400 having such a guidewire passageway. Specifically, the guidewire passage is from the proximal opening to the outer sheath 416 of the snare catheter 401, through the opening in the distal tip member 422, through the basket 102, and finally through the passage in the basket tip 414. extend through.

Other routes for guidewire 430 are also possible. For example, FIG. 138A shows a guidewire 430 extending outside the basket 405 and into a passageway that opens near the outside top of the basket tip 415 and at the bottom thereof and allows passage of the guidewire 430. There is. In this example, guidewire 430 does not pass inside basket 405. Alternatively, guidewire 430 passes through one of the meshes of basket 405, enters an internal opening to a passageway in basket tip 415, and extends distally from basket tip 415, as in FIG. 138B. It's okay.

Guidewire 430 may extend proximally only through steerable catheter 180, as shown in FIG. 138A, or through the passageway of either snare catheter 401 or cutting and capture catheter 403. It may extend proximally. Alternatively, guidewire 430 can be routed proximally through the exterior of steerable catheter 180, snare catheter 401, or cutting and capture catheter 403, except for basket tip 415, as shown in FIG. 138B. May be extended.

Alternatively, as seen in FIG. 139, the basket tip 415 is attached and extends distally from the tip 415 to aid passage through the valves and avoid damaging different structures of the heart. A guidewire-like pigtail or curved wire 431 may also be included.

The use of guidewire 430 to deliver removal system 400 may facilitate passage of multiple valve clips 40 through valves with smaller openings, particularly common in implanted valves. Moving over the guidewire 430 may make removal of the two valve clips 40 easier. For example, a catheter with a cutting loop 420 can be passed over the guidewire 430 and used to cut the leaflet tissue between the valve clips 40 such that the clips 40 are separated from each other and then sequentially can be supplemented via a removal system 400.

For sequential removal, the procedure consists of placing the steerable catheter 180 in the left atrium, moving the guidewire 430 through the target opening in the valve, and placing the cutting/supplemental catheter 403 over the guidewire 430. removing the guide wire 430; cutting and removing the valve clip 40 using the cutting/supplementing catheter 403; removing the cutting/supplementing catheter 403; It may include moving through the target opening and repeating the removal process. If the steerable catheter 180 has sufficient size to completely remove the valve clip 40, it may remain in place after removal of the first valve clip 40, otherwise the steerable catheter 180 can be removed and a second steerable catheter 180 placed.

Additionally, in some embodiments and procedures, it may be desirable for the cutting and capture catheter 403 to include a basket 460 that is expandable or extensible from a longitudinally compressed configuration. This allows the same size basket 460 to accommodate different sized valve clips 40 and allows the snare catheter 401 to "cover" the valve clip 40 without the need for multiple different sized baskets. . For example, FIG. 140 illustrates basket 460 in a longitudinally compressed configuration, and FIG. 141 illustrates basket 460 in an expanded configuration.

The longitudinally extensible functionality of basket 460 can be achieved in several different ways. For example, the basket 460 can be braided or woven from one or more wires of shape memory material (eg, Nitinol) and then heat set into a compressed configuration (FIG. 140). Instead of or in addition to heat-setting, the braid pattern may be configured to generally bias or at least promote basket 460 into a compressed configuration. Alternatively or additionally, basket 460 may include a longitudinally resilient tether or resilient outer cover to bias basket 460 into a compressed configuration. Alternatively, the wires of basket 460 may be constructed from a stretchable elastic material. In alternative embodiments, one or more of the struts/wires of basket 460 may be coiled to form a spring. In yet another alternative embodiment, a plurality of pull wires connected to the basket 460 and the proximal end of the device proximal to the user may maintain the basket 460 in a compressed configuration and release it accordingly to pull the proximal side. The diameter and/or length of basket 460 may also be increased.

The baskets described herein (eg, basket 102 or 460) have been shown to have a generally cylindrical expanded shape. However, other basket shapes are also possible. For example, FIG. 143A shows a basket 102' having a generally conical shape. As an example, the expanded basket shape tapers from about 30 mm to about 6 mm. When placed partially on the exterior of steerable catheter 180, as seen in FIG. 143B, the tapered shape forms a non-invasive, smooth shape without large edges. This prevents the steerable catheter 180 from getting caught or becoming stuck when passing through the valve, leaflets, and chordae tendineae. This shape also makes the basket easier to load with steerable catheter 180 or other catheters.

Although basket 102 is preferably included to supplement valve clip 40 or other cardiac treatment devices, basket 102 may be omitted from cutting and access catheter 403, as shown in FIG. 144. In such a device, snare loop 420 (and possible clip engagement as previously described) is moved proximally over clip 40 and snare loop 420 and is activated to cut the desired valve tissue. The valve clip 40 can be gripped using the joint features (fitting features). Snare loop 420 maintains its grip on valve clip 40 and clip 40 can be withdrawn proximally from the patient.

The specification and drawings include many different embodiments and features of removal devices and methods of use. Although features or techniques may be depicted in connection with a particular embodiment, it is contemplated in this application that features illustrated in any embodiment may be incorporated into other embodiments. It is a person's intention. In other words, any of the features described herein may be mixed and matched with each other and the claims therefore cover only the embodiments discussed and depicted herein. should not be limited or restricted to.

As used herein, the term "substantially" or "generally" refers to the complete or nearly complete range or extent of an operation, feature, property, condition, structure, item, or result. For example, an object that is "substantially" or "generally" surrounded can mean that the object is completely surrounded or almost completely surrounded. The exact permissible deviation from absolute perfection may depend on the particular situation. However, generally speaking, nearness of perfection will generally have the same overall result as if absolute and total perfection were obtained. The use of "substantially" or "generally" applies equally when used with a negative connotation referring to the complete or nearly complete absence of an action, feature, property, condition, structure, item, or result. It is possible. For example, an element, combination, embodiment, or composition that is "substantially free" or "generally free" of an ingredient or element does not actually contain such element unless it generally has a measurable effect. may be included in

As used herein, the term "one embodiment" or "an example" means that a particular element, feature, structure, or feature described in connection with this embodiment is included in at least one embodiment. means to be The appearances of the phrase "in one embodiment" in various places in the specification are not necessarily all referring to the same embodiment.

As used herein, the terms "comprises", "comprising", "includes", "including", "has", "having" )" or any other variations thereof are intended to include non-exclusive inclusion. For example, a process, method, article, or apparatus that includes a list of elements is not necessarily limited to only those elements and is not explicitly listed in such process, method, article, or apparatus. or may include other unique elements. Further, unless expressly stated to the contrary, "or" refers to an inclusive or and not to an exclusive or. For example, conditions A or B are such that A is true (or exists) and B is false (or does not exist), A is false (or does not exist) and B is true (or exists), and both A and B are true (or exists).

Additionally, the use of "a" or "an" is used to describe elements and components of embodiments herein. This is done merely for convenience and to give a general sense of the description. This description should be read to include one or at least one, and the singular also includes the plural unless it is obvious that it is meant otherwise.

Moreover, the figures depict preferred embodiments by way of example only. Those skilled in the art will readily recognize from the description herein that alternative embodiments of the structures and methods presented herein may be used without departing from the principles described herein. Will.

Although the invention has been described with respect to particular embodiments and applications, those skilled in the art will appreciate that, in light of this teaching, additional embodiments can be implemented without departing from the spirit or exceeding the scope of the claimed invention. and modifications can be generated. Accordingly, it should be understood that the drawings and descriptions herein are provided by way of example to facilitate understanding of the invention and are not to be construed as limiting its scope.

Claims (29)

A system for removing heart valve therapy, the system comprising:
a first elongated control member; a cutting loop secured to a distal portion of the first elongated control member and configured to cut tissue; a cutting and capture catheter comprising: a fixed basket;
a snare catheter having a second elongate control member and a snare loop secured to a distal portion of the second elongate control member;
The cutting loop is configured to move proximally of the snare loop, and the basket is configured to move around the snare loop during a removal procedure. . The system of claim 1, wherein the snare loop is saddle-shaped. The system of claim 1, wherein the snare loop has sides forming an arcuate shape that curves distally and then returns proximally with respect to the second elongate control member. The system of claim 1, wherein the snare loop has a circular shape with a notch on the opposite side of the second elongate control member. The system of claim 1, wherein a radially inner surface of the snare loop has a plurality of protrusions. The system of claim 1, wherein the snare loop has a helically wound coil. The snare catheter further includes an outer tubular sheath and a tip member disposed at a distal end of the outer tubular sheath, the second elongate control member moving through the outer tubular sheath and controlling the tip member. The system of claim 1, wherein the system is configured to move distally from the opening. the opening of the tip member further comprises an angled surface disposed along a sidewall of the tip member and configured to orient the snare loop generally perpendicular to an axis of the outer tubular sheath; 8. The system of claim 7. 9. The system of claim 8, wherein the tip member further comprises one or more of: 1) a plurality of grooves, 2) one or more longitudinal channels, and 3) a plurality of hooks. The system of claim 1, wherein the basket comprises a rounded or bulbous distal tip. The distal tip of the basket includes a guidewire passage configured for passage of a guidewire, the guidewire extending along an interior of the basket or an exterior of the basket. 11. The system of claim 10. 11. The system of claim 10, wherein the distal tip of the basket includes an attached distally extending curved wire. The system of claim 1, wherein the snare loop comprises an RF electrode configured to cut tissue. The snare catheter further includes a handle connected to a proximal end of the second elongate control member, the handle 1) locking the longitudinal position of the second elongate control member; or 2) configured to limit the force exerted by a user on the second elongated control member. The system of claim 1, wherein the basket has a conical shape when expanded. The system of claim 1, wherein the basket is longitudinally extensible. 2. The system of claim 1, comprising a chorda dilator with a body having a first passageway extending therethrough, and wherein the cutting and capture catheter is disposed within the first passageway. 18. The system of claim 17, wherein the body of the chordae dilator includes a second passageway, and a portion of the snare catheter is disposed in the second passageway. 19. The system of claim 18, wherein a distal surface of the body of the chordae dilator is sloped, rounded, or conical. A method of removing heart valve therapy from a heart valve, the method comprising:
Surrounding the heart valve treatment with a snare loop of a snare catheter;
tightening the snare loop around the heart valve treatment;
delivering the snare catheter distally to create a counterforce to the heart valve treatment;
positioning the cutting loop over the heart valve treatment such that the cutting loop is positioned between the heart valve treatment and the leaflets of the heart valve;
placing a basket at least partially over the heart valve treatment;
cutting tissue with the cutting loop to release the heart valve therapy from the heart valve;
closing the basket around the heart valve treatment. 20. Tightening the snare loop about the heart valve treatment further comprises activating a cutting element of the snare loop to cut at least a portion of tissue surrounding the heart valve treatment. The method described in. 21. The method of claim 20, further comprising deflecting the chordae with a chordae dilator. 21. Tightening the snare loop further includes preventing a distal end of the snare loop from being disposed distal to a distal end of the snare catheter. Method. A method of removing heart valve therapy from a heart valve, the method comprising:
delivering a push catheter proximal to the heart valve;
pushing the heart valve treatment distally with the pushing catheter to create a counterforce;
positioning the cutting loop over the heart valve treatment such that the cutting loop is positioned between the heart valve treatment and leaflets of the heart valve;
placing a basket at least partially over the heart valve treatment;
cutting tissue with the cutting loop to release the heart valve therapy from the heart valve;
closing the basket around the heart valve treatment. A method of removing heart valve therapy from a heart valve, the method comprising:
Surrounding the heart valve treatment with a snare loop of a snare catheter;
tightening the snare loop around the heart valve treatment;
delivering the snare catheter distally to create a counterforce to the heart valve treatment;
positioning the cutting loop over the heart valve treatment such that the cutting loop is positioned between the heart valve treatment and leaflets of the heart valve;
cutting tissue with the cutting loop to release the heart valve therapy from the heart valve;
removing the heart valve treatment through the snare catheter. A system for removing heart valve therapy, the system comprising:
a cutting catheter comprising a first elongate control member and a cutting loop secured to a distal portion of the first elongate control member and configured to cut tissue;
a snare catheter having a second elongate control member and a snare loop secured to a distal portion of the second elongate control member;
The system wherein the cutting loop is configured to move proximal to the snare loop. 27. The system of claim 26, wherein a snare loop comprises a first cutting element and the cutting loop comprises a second cutting element. A method of removing heart valve therapy from a heart valve, the method comprising:
delivering a basket tip from a distal opening of a delivery catheter, causing the basket tip to form a conical shape that smoothly transitions into the distal opening;
passing the delivery catheter and the partially exposed conical shape of the basket through a heart valve;
fully deploying the basket from the delivery catheter;
removing the heart valve treatment from the heart valve;
supplementing the heart valve therapy to the basket. A system for removing heart valve therapy, the system comprising:
a first elongated control member; a cutting loop secured to a distal portion of the first elongated control member and configured to cut tissue; a cutting and capture catheter comprising: a fixed basket;
A system comprising a snare catheter having a second elongate control member and a snare loop secured to a distal portion of the second elongate control member.

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