WO2019005501A1

WO2019005501A1 - Graphical display for intravascular catheter system

Info

Publication number: WO2019005501A1
Application number: PCT/US2018/037663
Authority: WO
Inventors: Chadi Harmouche
Original assignee: Cryterion Medical, Inc.
Priority date: 2017-06-30
Filing date: 2018-06-14
Publication date: 2019-01-03

Abstract

An intravascular catheter system (10) for treating a patient (12) during an ablation procedure includes a graphical display (24) that is configured to display a compilation of data including information regarding at least one of (i) thoracic movement of the patient (12) indicative of operation of a phrenic nerve of the patient (12), (ii) a temperature rate change of a cryogenic fluid (26) within the patient (12), (iii) a target ablation temperature, (iv) a summary that includes one or more ablation locations, a number of ablations at each location and a duration of each ablation at each location, (v) a selection process for determining the ablation location, and (vi) a selection process to specify one or more of the target ablation temperature and the ablation location.

Description

GRAPHICAL DISPLAY FOR INTRAVASCULAR CATHETER SYSTEM

RELATED APPLICATION

[0001] This application claims priority on U.S. Provisional Application Serial No. 62/527,277, filed on June 30, 2017, and entitled "GRAPHICAL DISPLAY FOR CRYOGENIC BALLOON CATHETER SYSTEM". As far as permitted, the contents of U.S. Provisional Application Serial No. 62/527,277 are incorporated in their entirety herein by reference.

BACKGROUND

[0002] Cardiac arrhythmias involve an abnormality in the electrical conduction of the heart and are a leading cause of stroke, heart disease, and sudden cardiac death. Treatment options for patients with arrhythmias include medications and/or the use of medical devices, which can include implantable devices and/or catheter ablation of cardiac tissue, to name a few. In particular, catheter ablation involves delivering ablative energy to tissue inside the heart to block aberrant electrical activity from depolarizing heart muscle cells out of synchrony with the heart's normal conduction pattern. The procedure is performed by positioning the tip of an energy delivery catheter adjacent to diseased or targeted tissue in the heart. The energy delivery component of the system is typically at or near the most distal (i.e. farthest from the user or operator) portion of the catheter, and often at the tip of the catheter.

[0003] Various forms of energy can be used to ablate diseased heart tissue. These can include radio frequency (RF), cryogenics, ultrasound and laser energy, to name a few. During a cryoablation procedure, with the aid of a guide wire, the distal tip of the catheter is positioned adjacent to targeted cardiac tissue, at which time energy is delivered to create tissue necrosis, rendering the ablated tissue incapable of conducting electrical signals. The dose of the energy delivered is a critical factor in increasing the likelihood that the treated tissue is permanently incapable of conduction. At the same time, delicate collateral tissue, such as the esophagus, the bronchus, and the phrenic nerve surrounding the ablation zone can be damaged and can lead to undesired complications. Thus, the operator must finely balance delivering therapeutic levels of energy to achieve intended tissue necrosis while avoiding excessive energy leading to collateral tissue injury.

[0004] Atrial fibrillation (AF) is one of the most common arrhythmias treated using catheter ablation. In the earliest stages of the disease, paroxysmal AF, the treatment strategy involves isolating the pulmonary veins from the left atrial chamber. Recently, the use of techniques known as "balloon cryotherapy" catheter procedures to treat AF has increased. In part, this stems from the balloon cryotherapy's ease of use, shorter procedure times and improved patient outcomes. Despite these advantages, there remains needed improvement to further improve patient outcomes and to better facilitate real-time physiological monitoring of tissue to optimally titrate energy to perform both reversible "ice mapping" and permanent tissue ablation.

[0005] The goal of balloon cryotherapy is to completely isolate one or more pulmonary veins of the patient by creating circumferential transmural lesions around an ostium of the pulmonary vein being treated. During balloon cryotherapy, one or more cryogenic balloons are placed against the ostium of the pulmonary vein to occlude the pulmonary vein from blood flow. Pulmonary vein occlusion is typically a strong indicator that complete circumferential contact is achieved between the balloon and ostium of the pulmonary vein for optimal heat transfer during ablation. With the cryogenic balloons appropriately positioned to occlude the targeted tissue, e.g., the pulmonary vein, a cryogenic fluid (such as nitrous oxide, or any other suitable fluid) is delivered under pressure to an interior of the one or more cryogenic balloons. Using this method, the extremely frigid fluid causes necrosis of the targeted tissue, thereby rendering the ablated tissue incapable of conducting unwanted electrical signals.

SUMMARY

[0006] The present invention is directed toward an intravascular catheter system for treating a patient during an ablation procedure. In one embodiment, the intravascular catheter system includes a graphical display that is configured to display a compilation of data including information regarding at least one of (i) thoracic movement of the patient indicative of operation of a phrenic nerve of the patient, (ii) a temperature rate change of the cryogenic fluid within the patient, (iii) a target ablation temperature, (iv) a summary that includes one or more ablation locations, a number of ablations at each location and a duration of each ablation at each location, (v) a selection process for determining the ablation location, and (vi) a selection process to specify one or more of the target ablation temperature and the ablation location.

[0007] In various embodiments, the intravascular catheter system can also include a controller that sends the compilation of data to the graphical display. In certain embodiments, the intravascular catheter system also includes a balloon catheter. The controller can receive at least a portion of the compilation of data from the balloon catheter.

[0008] In an alternative embodiment, the intravascular catheter system includes a graphical display that is configured to display a compilation of data including information regarding each of (i) thoracic movement of the patient indicative of operation of a phrenic nerve of the patient, (ii) a temperature rate change of a cryogenic fluid within the patient, (iii) a target ablation temperature, (iv) a summary that includes one or more ablation locations, a number of ablations at each location and a duration of each ablation at each location, (v) a selection process for determining the ablation location, and (vi) a selection process to specify one or more of the target ablation temperature and the ablation location.

[0009] Additionally, in some embodiments, the graphical display is further configured to display a set of data including information regarding an esophageal temperature of the patient. Further, in certain embodiments, the graphical display is also configured to display a set of data including information regarding a time to reach the target ablation temperature. Still further, in some embodiments, the graphical display is also configured to display a set of data including information regarding a time for a temperature to increase from an actual ablation temperature to a preset thaw temperature. Yet further, in certain embodiments, the graphical display is further configured to display a set of data including information regarding an actual ablation temperature.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The novel features of this invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying drawing, taken in conjunction with the accompanying description, in which similar reference characters refer to similar parts, and in which:

[0011] Figure 1 is a simplified schematic side view illustration of a patient and one embodiment of an intravascular catheter system including a graphical display having features of the present invention;

[0012] Figure 2 is a simplified schematic side view illustration of a portion of the patient and a portion of an embodiment of the intravascular catheter system including an embodiment of the graphical display;

[0013] Figure 3 is an embodiment of a representative first set of data illustrated on the graphical display;

[0014] Figure 4 is an embodiment of a representative second set of data illustrated on the graphical display;

[0015] Figure 5 is an embodiment of a representative third set of data illustrated on the graphical display;

[0016] Figure 6 is an embodiment of a representative fourth set of data illustrated on the graphical display; [0017] Figure 7 is an embodiment of a representative fifth set of data illustrated on the graphical display;

[0018] Figure 8 is an embodiment of a representative sixth set of data illustrated on the graphical display;

[0019] Figure 9 is an embodiment of a representative seventh set of data illustrated on the graphical display;

[0020] Figure 10 is an embodiment of a representative eighth set of data illustrated on the graphical display;

[0021] Figure 1 1 is an embodiment of a representative ninth set of data illustrated on the graphical display;

[0022] Figure 12 is an embodiment of a representative tenth set of data illustrated on the graphical display; and

[0023] Figure 13 is an embodiment of a representative compilation of data illustrated on the graphical display.

DESCRIPTION

[0024] Embodiments of the present invention are described herein in the context of a graphical user interface (also referred to herein as a "graphical display") for use within an intravascular catheter system. In particular, in various embodiments, the graphical display can provide an operator of the intravascular catheter system with various information and data that can be used before, during and after an ablation procedure, e.g., a cryoablation procedure.

[0025] Those of ordinary skill in the art will realize that the following detailed description of the present invention is illustrative only and is not intended to be in any way limiting. Other embodiments of the present invention will readily suggest themselves to such skilled persons having the benefit of this disclosure. Reference will now be made in detail to implementations of the present invention as illustrated in the accompanying drawings.

[0026] In the interest of clarity, not all of the routine features of the implementations described herein are shown and described. It will, of course, be appreciated that in the development of any such actual implementation, numerous implementation-specific decisions must be made in order to achieve the developer's specific goals, such as compliance with application-related and business-related constraints, and that these specific goals will vary from one implementation to another and from one developer to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking of engineering for those of ordinary skill in the art having the benefit of this disclosure.

[0027] Although the disclosure provided herein focuses mainly on cryogenics, it is understood that various other forms of energy can be used to ablate diseased heart tissue. These can include radio frequency (RF), ultrasound and laser energy, as non-exclusive examples. The present invention is intended to be effective with any or all of these and other forms of energy.

[0028] Figure 1 is a simplified schematic side view illustration of an embodiment of a medical device 10 for use with a patient 12, which can be a human being or an animal. Although the specific medical device 10 illustrated and described herein pertains to and refers to an intravascular catheter system 10 such as a cryogenic balloon catheter system, it is understood and appreciated that other types of medical devices 10 or systems can equally benefit by the teachings provided herein. For example, in certain non-exclusive alternative embodiments, the present invention can be equally applicable for use with any suitable types of ablation systems and/or any suitable types of catheter systems. Thus, the specific reference herein to use as part of an intravascular catheter system is not intended to be limiting in any manner.

[0029] The design of the intravascular catheter system 10 can be varied. In certain embodiments, such as the embodiment illustrated in Figure 1 , the intravascular catheter system 10 can include one or more of a controller 14 (illustrated in phantom), a fluid source 16 (illustrated in phantom), a balloon catheter 18, a handle assembly 20, a control console 22, and a graphical display 24. [0030] It is understood that although Figure 1 illustrates the structures of the intravascular catheter system 10 in a particular position, sequence and/or order, these structures can be located in any suitably different position, sequence and/or order than that illustrated in Figure 1 . It is also understood that the intravascular catheter system 10 can include fewer or additional components than those specifically illustrated and described herein.

[0031] In various embodiments, the controller 14 is configured to monitor and control various processes of the ablation procedure. More specifically, the controller 14 can monitor and control release and/or retrieval of a cooling fluid 26 (e.g., a cryogenic fluid) to and/or from the balloon catheter 18. The controller 14 can also control various structures that are responsible for maintaining and/or adjusting a flow rate and/or pressure of the cryogenic fluid 26 that is released to the balloon catheter 18 during the cryoablation procedure. In such embodiments, the intravascular catheter system 10 delivers ablative energy in the form of cryogenic fluid 26 to cardiac tissue of the patient 12 to create tissue necrosis, rendering the ablated tissue incapable of conducting electrical signals. Additionally, in various embodiments, the controller 14 can control activation and/or deactivation of one or more other processes of the balloon catheter 18. Further, or in the alternative, the controller 14 can receive data and/or other information (hereinafter sometimes referred to as "sensor output") from various structures within the intravascular catheter system 10. In some embodiments, the controller 14 can receive, monitor, assimilate and/or integrate the sensor output, and/or any other data or information received from any structure within the intravascular catheter system 10 in order to control the operation of the balloon catheter 18. As provided herein, in various embodiments, the controller 14 can initiate and/or terminate the flow of cryogenic fluid 26 to the balloon catheter 18 based on the sensor output. Still further, or in the alternative, the controller 14 can control positioning of portions of the balloon catheter 18 within the body of the patient 12, and/or can control any other suitable functions of the balloon catheter 18.

[0032] The fluid source 16 contains the cryogenic fluid 26, which is delivered to the balloon catheter 18 with or without input from the controller 14 during a cryoablation procedure. Once the ablation procedure has initiated, the cryogenic fluid 26 can be delivered to the balloon catheter 18 and the resulting gas, after a phase change, can be retrieved from the balloon catheter 18, and can either be vented or otherwise discarded as exhaust. Additionally, the type of cryogenic fluid 26 that is used during the cryoablation procedure can vary. In one non-exclusive embodiment, the cryogenic fluid 26 can include liquid nitrous oxide. However, any other suitable cryogenic fluid 26 can be used. For example, in one non-exclusive alternative embodiment, the cryogenic fluid 26 can include liquid nitrogen.

[0033] The design of the balloon catheter 18 can be varied to suit the specific design requirements of the intravascular catheter system 10. As shown, the balloon catheter 18 is inserted into the body of the patient 12 during the cryoablation procedure. In one embodiment, the balloon catheter 18 can be positioned within the body of the patient 12 using the controller 14. Stated in another manner, the controller 14 can control positioning of the balloon catheter 18 within the body of the patient 12. Alternatively, the balloon catheter 18 can be manually positioned within the body of the patient 12 by a healthcare professional (also referred to herein as an "operator"). As used herein, a healthcare professional and/or an operator can include a physician, a physician's assistant, a nurse and/or any other suitable person and/or individual. In certain embodiments, the balloon catheter 18 is positioned within the body of the patient 12 utilizing at least a portion of the sensor output that is received by the controller 14. For example, in various embodiments, the sensor output is received by the controller 14, which can then provide the operator with information regarding the positioning of the balloon catheter 18. Based at least partially on the sensor output feedback received by the controller 14, the operator can adjust the positioning of the balloon catheter 18 within the body of the patient 12 to ensure that the balloon catheter 18 is properly positioned relative to targeted cardiac tissue (not shown). While specific reference is made herein to the balloon catheter 18, as noted above, it is understood that any suitable type of medical device and/or catheter may be used.

[0034] The handle assembly 20 is handled and used by the operator to operate, position and control the balloon catheter 18. The design and specific features of the handle assembly 20 can vary to suit the design requirements of the intravascular catheter system 10. In the embodiment illustrated in Figure 1 , the handle assembly 20 is separate from, but in electrical and/or fluid communication with the controller 14, the fluid source 16, and the graphical display 24. In some embodiments, the handle assembly 20 can integrate and/or include at least a portion of the controller 14 within an interior of the handle assembly 20. It is understood that the handle assembly 20 can include fewer or additional components than those specifically illustrated and described herein.

[0035] In various embodiments, the handle assembly 20 can be used by the operator to initiate and/or terminate the cryoablation process, e.g., to start the flow of the cryogenic fluid 26 to the balloon catheter 18 in order to ablate certain targeted heart tissue of the patient 12. In certain embodiments, the controller 14 can override use of the handle assembly 20 by the operator. Stated in another manner, in some embodiments, based at least in part on the sensor output, the controller 14 can terminate the cryoablation process without the operator using the handle assembly 20 to do so.

[0036] The control console 22 is coupled to the balloon catheter 18 and the handle assembly 20. Additionally, in the embodiment illustrated in Figure 1 , the control console 22 includes at least a portion of the controller 14, the fluid source 16, and the graphical display 24. However, in alternative embodiments, the control console 22 can contain additional structures not shown or described herein. Still alternatively, the control console 22 may not include various structures that are illustrated within the control console 22 in Figure 1 . For example, in certain nonexclusive alternative embodiments, the control console 22 does not include the graphical display 24.

[0037] In various embodiments, the graphical display 24 is electrically connected to the controller 14. Additionally, the graphical display 24 provides the operator of the intravascular catheter system 10 with information and data that can be used before, during and after the cryoablation procedure. For example, the graphical display 24 can provide the operator with information based on the sensor output, and any other relevant information that can be used before, during and after the cryoablation procedure. The specifics of the graphical display 24 can vary depending upon the design requirements of the intravascular catheter system 10, or the specific needs, specifications and/or desires of the operator.

[0038] In one embodiment, the graphical display 24 is configured to provide static visual data and/or information to the operator. In addition, or in the alternative, the graphical display 24 can be configured to provide dynamic visual data and/or information to the operator, such as video data or any other data that changes over time, e.g., during an ablation procedure, as provided in greater detail herein. Further, in various embodiments, the graphical display 24 can include one or more colors, different sizes, varying brightness, etc., that may act as alerts to the operator. Additionally, or in the alternative, the graphical display 24 can be configured to provide audio data or information to the operator.

[0039] Figure 2 is a simplified schematic side view illustration of a portion of one embodiment of the intravascular catheter system 210 and a portion of a patient 212. In the embodiment illustrated in Figure 2, the intravascular catheter system 210 includes one or more of a controller 214 (illustrated in phantom), a fluid source 216 (illustrated in phantom), a balloon catheter 218, a handle assembly 220, a control console 222, and a graphical display 224.

[0040] The controller 214 is configured to control various functions of the intravascular catheter system 210. As shown in Figure 2, in certain embodiments, the controller 214 can be positioned substantially within the control console 222. Alternatively, at least a portion of the controller 214 can be positioned in one or more other locations within the intravascular catheter system 210, e.g., within the handle assembly 220. In various embodiments, the controller 214 can receive sensor output (also sometimes referred to herein as "data" or a "compilation of data") or other output from the balloon catheter 218, and can send the sensor output to the graphical display 224. Further, the controller 214 can control various functions of the remainder of the intravascular catheter system 210 based at least in part on data or other information received by the controller 214.

[0041] The design of the balloon catheter 218 can be varied to suit the design requirements of the intravascular catheter system 210. In this embodiment, the balloon catheter 218 includes one or more of a guidewire 230, a guidewire lumen 232, a catheter shaft 234, an inner balloon 236 and an outer balloon 238. It is recognized that the inner balloon 236 and the outer balloon 238 can also be referred to as a "first balloon" and a "second balloon", and that either balloon 236, 238 can be the first balloon or the second balloon. Alternatively, the balloon catheter 218 can be configured to include only a single balloon. It is also understood that the balloon catheter 218 can include other structures as well. However, for the sake of clarity, these other structures have been omitted from the Figures.

[0042] As shown in the embodiment illustrated in Figure 2, the balloon catheter 218 is configured to be positioned within the circulatory system 240 of the patient 212. The guidewire 230 and guidewire lumen 232 are inserted into a pulmonary vein 242 of the patient 212, and the catheter shaft 234 and the balloons 236, 238 are moved along the guidewire 230 and/or the guidewire lumen 232 to near an ostium 244 of the pulmonary vein 242. In general, it is the object of the balloon catheter 218 to seal the pulmonary vein 242 so that blood flow is occluded. Only when occlusion is achieved does the cryothermic energy, e.g., of the cryogenic fluid 26 (illustrated in Figure 1 ), cause tissue necrosis which, in turn, provides for electrically blocking aberrant electrical signals that trigger atrial fibrillation.

[0043] Additionally, as shown, the guidewire lumen 232 encircles at least a portion of the guidewire 230. During use, the guidewire 230 is inserted into the guidewire lumen 232 and can course through the guidewire lumen 232 and extend out of a distal end 232A of the guidewire lumen 232. In various embodiments, the guidewire 230 can also include a mapping catheter (not shown) that maps electrocardiograms in the heart, and/or can provide information needed to position at least portions of the balloon catheter 218 within the patient 212.

[0044] As illustrated in this embodiment, the inner balloon 236 is positioned substantially, if not completely, within the outer balloon 238. The specific design of and materials used for each of the balloons 236, 238 can be varied. For example, in some non-exclusive embodiments, the balloons 236, 238 can be formed from one or more of various grades of polyether block amides (PEBA), polyurethane, polyethylene terephthalate (PET), nylon, and other co-polymers of these materials. Alternatively, the balloons 236, 238 can be formed from other suitable materials.

[0045] Additionally, in some embodiments, one end of the inner balloon 236 is bonded to a distal end 234A of the catheter shaft 234, and the other end of the inner balloon 236 is bonded near the distal end 232A of the guidewire lumen 232. Further, one end of the outer balloon 238 may be bonded to a neck of the inner balloon 236 or to the distal end 234A of the catheter shaft 234, and the other end of the outer balloon 238 may be bonded to the guidewire lumen 232. It is appreciated that a variety of bonding techniques can be used and include heat bonding and adhesive bonding. Additionally, it is further appreciated that in embodiments that include only a single balloon, the balloon can be secured to the catheter shaft 234 and the guidewire lumen 232 in a similar manner. Alternatively, the balloons 236, 238 can be secured to other suitable structures.

[0046] During use, the inner balloon 236 can be partially or fully inflated so that at least a portion of the inner balloon 236 expands against at least a portion of the outer balloon 238. Stated in another manner, during use of the balloon catheter 218, at least a portion of an outer surface 236A of the inner balloon 236 expands and is positioned substantially directly against a portion of an inner surface 238A of the outer balloon 238. At certain times during usage of the intravascular catheter system 210, the inner balloon 236 and the outer balloon 238 define an inter-balloon space 246, or gap, between the balloons 236, 238. The inter-balloon space 246 is illustrated between the inner balloon 236 and the outer balloon 238 in Figure 2 for clarity, although it is understood that at certain times during usage of the intravascular catheter system 210, the inter-balloon space 246 has very little or no volume. As provided herein, once the inner balloon 236 is sufficiently inflated, an outer surface 238B of the outer balloon 238 can then be positioned within the circulatory system 240 of the patient 212 to abut and/or substantially form a seal with the ostium 244 of the pulmonary vein 242 to be treated.

[0047] The design of the handle assembly 220 can vary. In the embodiment illustrated in Figure 2, the handle assembly 220 can include circuitry 248 that can form a portion of the controller 214. Alternatively, the circuitry 248 can transmit electrical signals such as the sensor output or otherwise provide data to the controller 214. In one embodiment, the circuitry 248 can include a printed circuit board having one or more integrated circuits, or any other suitable circuitry. In an alternative embodiment, the circuitry 248 can be omitted, or can be included within the controller 214, which in various embodiments can be positioned outside of the handle assembly 220, e.g., within the control console 222.

[0048] As an overview, in various embodiments, the graphical display 224 receives data (or a compilation of data) from the controller 214. In various embodiments, the graphical display 224 is configured to provide the operator with various forms and types of information or data that can be used by the operator before, during and after an ablation procedure. More specifically, in such embodiments, the graphical display 224 can provide visual and/or audio information or data to the operator that pertains to one or more of (i) thoracic movement of the patient indicative of operation of a phrenic nerve of the patient, (ii) an esophageal temperature of the patient, (iii) a temperature rate change of the cryogenic fluid within the patient, (iv) a time to reach a target ablation temperature, (v) a target ablation temperature or target ablation temperature range, (vi) a time for a temperature to increase from an actual ablation temperature to a preset thaw temperature, (vii) an actual ablation temperature or an actual ablation temperature range, (viii) a summary that includes one or more of: one or more ablation locations, a number of ablations at each location and a duration of each ablation at each location, (ix) a selection process for determining an ablation location, and (x) a selection process to specify a temperature target and/or an ablation location (or site). Additionally, or in the alternative, the graphical display 224 can provide still other types of information or data that can be used by the operator before, during and after an ablation procedure.

[0049] Figure 3 is an embodiment of a portion of a graphical display 324 including a first set of data 350. In this embodiment, the first set of data 350 can include information pertaining to thoracic movement of the patient 12 (illustrated in Figure 1 ). In certain embodiments, the first set of data 350 regarding thoracic movement of the patient 12 can include and/or incorporate phrenic nerve monitoring. Stated in another manner, the information regarding thoracic movement of the patient 12 can be indicative of operation of the phrenic nerve of the patient 12. For example, movement of the diaphragm of the patient 12 can be monitored to determine if there may be an injury or potential injury to the phrenic nerve. Therefore, in one embodiment, as shown in Figure 3, thoracic movement can be displayed as movement as a function of time. Further, if the movement exceeds or drops below a given (or predetermined) threshold, an alarm (visual and/or audio) can be generated to alert the operator(s) and/or stop the cryoablation procedure.

[0050] Figure 4 is an embodiment of a portion of a graphical display 424 including a second set of data 450. In this embodiment, the second set of data 450 can include information pertaining to an esophageal temperature of the patient 12 (illustrated in Figure 1 ). Esophageal fistula, i.e. an abnormal connection between the esophagus and another organ in the body of the patient 12, is one of the risks involved in ablation procedures. One current method used to assess if the esophagus is negatively impacted is to measure its temperature and stop injection if the temperature reaches below a predetermined value. In one embodiment, as shown in Figure 4, the esophageal temperature can be displayed in the form of a graph of temperature over time. In another embodiment, the esophageal temperature can be displayed as a number in Fahrenheit, Celsius or Kelvin. Still alternatively, the esophageal temperature can be displayed as a change in temperature. Further, if the esophageal temperature exceeds or drops below a given (or predetermined) threshold, an alarm (visual and/or audio) can be generated to alert the operator(s) and/or stop the cryoablation procedure.

[0051] Figure 5 is an embodiment of a portion of a graphical display 524 including a third set of data 550. In this embodiment, the third set of data 550 can include information pertaining to a temperature rate decrease or increase (generically, "temperature rate change") of the cryogenic fluid 26 (illustrated in Figure 1 ) or any other part of the balloon catheter 18 (illustrated in Figure 1 ). In the embodiment illustrated in Figure 5, both a temperature change rate 552 and a maximum temperature change rate 554 can be displayed during the cryoablation procedure. This data can be important to the operator(s) because relatively slow descending temperatures (low rate) may indicate poor vein occlusion or high heat load. Conversely, relatively high temperature change rates may indicate potential undesired tissue damage. The form of the third set of data 550 that is displayed can be varied. For example, in one embodiment, actual numerical values can be shown. Alternatively, or in addition, the third set of data 550 can include a graph of temperature rate over time. However, any suitable form of the third set of data 550 can be used.

[0052] Figure 6 is an embodiment of a portion of a graphical display 624 including a fourth set of data 650. In this embodiment, the fourth set of data 650 can include information pertaining to time to reach a target ablation temperature or a target ablation temperature range. The time to reach a preset target ablation temperature or the target ablation temperature range may be a good indicator of ablation quality. For example, a relatively long time to reach ablation target temperature or the target ablation temperature range may indicate poor vein occlusion or a high heat load. Conversely, a relatively short time may indicate potential undesired tissue damage. In the embodiment illustrated in Figure 6, the target ablation temperature is -30 degrees Celsius, which can be set by the operator(s) or can be automatically set. Alternatively, the target ablation temperature can include a range of temperatures, e.g. between -20 degrees Celsius and -40 degrees Celsius, as one non-exclusive representative example. As shown in Figure 6, a time to reach this temperature or temperature range can also be displayed. Additionally, or in the alternative, minimum and maximum temperature alarms can be set by the operator(s).

[0053] Figure 7 is an embodiment of a portion of a graphical display 724 including a fifth set of data 750. In this embodiment, the fifth set of data 750 can include information and/or data relating to a system message, including a target ablation temperature 756 and/or a target ablation temperature range. In one embodiment, the target ablation temperature 756 and/or the target ablation temperature range can be set by the operator(s) or the target ablation temperature 756 and/or the target ablation temperature range can have a default setting. Additionally, or in the alternative, in some embodiments, as shown in Figure 7, the system message can include one or more of a minimum temperature alarm 758 and a high temperature alarm 760, either or both of which can be set by the operator(s) or can have default settings.

[0054] Figure 8 is an embodiment of a portion of a graphical display 824 including a sixth set of data 850. In this embodiment, the sixth set of data 850 can include information pertaining to a time to thaw. As used herein, the time to thaw can be the time it takes the temperature to increase from actual ablation temperatures (e.g. -60 degrees Celsius) to a preset thaw temperature (e.g. 20 degrees Celsius), which can be an indicator of ablation quality. For example, relatively short thaw times can indicate low quality ablations while relatively long thaw times can indicate better ablation quality. The sixth set of data 750 can be displayed in the form of numerical values and/or graphical information of temperature change as a function of time.

[0055] Figure 9 is an embodiment of a portion of a graphical display 924 including a seventh set of data 950. In this embodiment, the seventh set of data 950 can include information pertaining to an actual ablation temperature. The actual ablation temperature can be an indicator of ablation quality and/or potential harm to the patient 12 (illustrated in Figure 1 ). A relatively low actual ablation temperature can indicate too much cooling and can signal the potential for inadvertent collateral tissue damage such as phrenic nerve damage. In one embodiment, the graphical display 924 can display the seventh set of data 950 in a distinct color if actual ablation temperatures go above or below a set value. In alternative embodiments, the set value can be determined by the operator(s) or the set value can be a default value. In one embodiment, actual numerical values of the temperature can be shown. Alternatively, or in addition, as shown in Figure 9, the seventh set of data 950 can include a graph of temperature over time. However, any suitable form of the seventh set of data 950 can be used.

[0056] Figure 10 is an embodiment of a portion of a graphical display 1024 including an eighth set of data 1050. In this embodiment, the eighth set of data 1050 can include information pertaining to a summary of one or more of ablation locations 1062, number of ablations 1064 at each location and/or the duration 1066 of each ablation. This type of summary saves the operator(s) from having to manually track this information. [0057] Figure 1 1 is an embodiment of a portion of a graphical display 1 124 including a ninth set of data 1 150. In this embodiment, the ninth set of data 1 150 can include information and/or data relating to a system message, such as a determination of the ablation location 1 168 or site. For example, the information and/or data in the ninth set of data 1 150 can include a specific pulmonary vein that is being targeted. In this embodiment, the operator(s) can input the ablation location that is currently subject to cryoablation, either from a dropdown menu 1 170 or by some other suitable selection method.

[0058] Figure 12 is an embodiment of a portion of a graphical display 1224 including a tenth set of data 1250. In this embodiment, the tenth set of data 1250 can include a selection process for the operator(s) to specify a target ablation temperature 1272 and/or an ablation location 1274 or site. As with any of the embodiments provided herein, the graphical display 1224 can include a touchscreen 1276 or other method of selecting the target ablation temperature 1272 and/or the ablation location 1274 or site. The operator(s) can further input additional information once the target ablation temperature 1272 and/or the ablation location 1274 have been selected.

[0059] Figure 13 is one embodiment of a compilation of data 1378 illustrated on the graphical display 1324. In this embodiment, the graphical display 1324 includes a compilation of a plurality of sets of data 350, 450, 550, 650, 750, 850, 950, 1050, 1 150, 1250, such as those previously described herein relative to Figures 3-12. It is understood that the compilation of data 1378 that can be displayed on the graphical display 1324 can include all of the sets of data 350, 450, 550, 650, 750, 850, 950, 1050, 1 150, 1250, previously described herein. Alternatively, the graphical display 1324 can include additional sets of data not described herein. Additionally, or in the alternative, the graphical display 1324 can omit one or more sets of data 350, 450, 550, 650, 750, 850, 950, 1050, 1 150, 1250, previously described herein. Stated another way, the graphical display 1324 illustrated in Figure 13 provides one representative embodiment of a graphical display 1324 that shows a compilation of a plurality of sets of data that can be useful to the operator(s) before, during and/or after a cryoablation procedure. [0060] It is further understood that in one embodiment any or all of the sets of data that are illustrated in Figure 13 can be manually repositioned by the operator(s) at any time to suit the specific needs of the operator(s). It is also recognized that the sets of data illustrated in Figure 13 can be resized, either smaller or larger, to suit the design requirements of the operator(s). In other words, certain sets of data may be more relevant or important at particular times before, during and/or after a cryoablation procedure. Repositioning and/or resizing of one or more sets of data can occur before, during and/or after the cryoablation procedure, as required by the operator(s). Thus, certain sets of data may need to be more prominently displayed (or less prominently displayed) depending upon the phase of the cryoablation procedure. The repositioning and/or resizing of one or more sets of data can occur manually by the operator(s), automatically as preset by the operator(s), or by a default setting.

[0061] It is understood that although a number of different embodiments of the intravascular catheter system 10 and the graphical display 24 have been illustrated and described herein, one or more features of any one embodiment can be combined with one or more features of one or more of the other embodiments, provided that such combination satisfies the intent of the present invention.

[0062] While a number of exemplary aspects and embodiments of the intravascular catheter system 10 and the graphical display 24 have been discussed above, those of skill in the art will recognize certain modifications, permutations, additions and sub-combinations thereof. It is therefore intended that the following appended claims and claims hereafter introduced are interpreted to include all such modifications, permutations, additions and sub-combinations as are within their true spirit and scope.

Claims

What is claimed is:

1 . An intravascular catheter system for treating a patient during an ablation procedure, the intravascular catheter system comprising:

a graphical display that is configured to display a compilation of data including information regarding at least one of (i) thoracic movement of the patient indicative of operation of a phrenic nerve of the patient, (ii) a temperature rate change of a cryogenic fluid within the patient, (iii) a target ablation temperature, (iv) a summary that includes one or more ablation locations, a number of ablations at each location and a duration of each ablation at each location, (v) a selection process for determining the ablation location, and (vi) a selection process to specify one or more of the target ablation temperature and the ablation location.

2. The intravascular catheter system of claim 1 wherein the graphical display is configured to display the compilation of data including information regarding at least two of (i) thoracic movement of the patient indicative of operation of the phrenic nerve of the patient, (ii) the temperature rate change of the cryogenic fluid within the patient, (iii) the target ablation temperature, (iv) the summary that includes the one or more ablation locations, the number of ablations at each location and the duration of each ablation at each location, (v) the selection process for determining the ablation location, and (vi) the selection process to specify one or more of the target ablation temperature and the ablation location.

3. The intravascular catheter system of claim 2 wherein the graphical display is configured to display the compilation of data including information regarding at least three of (i) thoracic movement of the patient indicative of operation of the phrenic nerve of the patient, (ii) the temperature rate change of the cryogenic fluid within the patient, (iii) the target ablation temperature, (iv) the summary that includes the one or more ablation locations, the number of ablations at each location and the duration of each ablation at each location, (v) the selection process for determining the ablation location, and (vi) the selection process to specify one or more of the target ablation temperature and the ablation location.

4. The intravascular catheter system of claim 3 wherein the graphical display is configured to display the compilation of data including information regarding at least four of (i) thoracic movement of the patient indicative of operation of the phrenic nerve of the patient, (ii) the temperature rate change of the cryogenic fluid within the patient, (iii) the target ablation temperature, (iv) the summary that includes the one or more ablation locations, the number of ablations at each location and the duration of each ablation at each location, (v) the selection process for determining the ablation location, and (vi) the selection process to specify one or more of the target ablation temperature and the ablation location.

5. The intravascular catheter system of claim 4 wherein the graphical display is configured to display the compilation of data including information regarding at least five of (i) thoracic movement of the patient indicative of operation of the phrenic nerve of the patient, (ii) the temperature rate change of the cryogenic fluid within the patient, (iii) the target ablation temperature, (iv) the summary that includes the one or more ablation locations, the number of ablations at each location and the duration of each ablation at each location, (v) the selection process for determining the ablation location, and (vi) the selection process to specify one or more of the target ablation temperature and the ablation location.

6. The intravascular catheter system of claim 5 wherein the graphical display is configured to display the compilation of data including information regarding each of (i) thoracic movement of the patient indicative of operation of the phrenic nerve of the patient, (ii) the temperature rate change of the cryogenic fluid within the patient, (iii) the target ablation temperature, (iv) the summary that includes the one or more ablation locations, the number of ablations at each location and the duration of each ablation at each location, (v) the selection process for determining the ablation location, and (vi) the selection process to specify one or more of the target ablation temperature and the ablation location.

7. The intravascular catheter system of claim 1 wherein the graphical display is further configured to display a set of data including information regarding an esophageal temperature of the patient.

8. The intravascular catheter system of claim 1 wherein the graphical display is further configured to display a set of data including information regarding a time to reach the target ablation temperature.

9. The intravascular catheter system of claim 1 wherein the graphical display is further configured to display a set of data including information regarding a time for a temperature to increase from an actual ablation temperature to a preset thaw temperature.

10. The intravascular catheter system of claim 1 wherein the graphical display is further configured to display a set of data including information regarding an actual ablation temperature.

1 1 . The intravascular catheter system of claim 1 further comprising a controller that sends the compilation of data to the graphical display.

12. The intravascular catheter system of claim 1 1 further comprising a balloon catheter, wherein the controller receives at least a portion of the compilation of data from the balloon catheter.

13. An intravascular catheter system for treating a patient during an ablation procedure, the intravascular catheter system comprising:

a graphical display that is configured to display a set of data including information regarding thoracic movement of the patient indicative of operation of a phrenic nerve of the patient.

14. An intravascular catheter system for treating a patient during an ablation procedure, the intravascular catheter system comprising:

a graphical display that is configured to display a set of data including information regarding an esophageal temperature of the patient.

15. An intravascular catheter system for treating a patient during an ablation procedure, the intravascular catheter system comprising:

a balloon catheter that is configured to be positioned at least partially within the patient;

a fluid source that contains a cryogenic fluid that is delivered to the balloon catheter; and

a graphical display that is configured to display a set of data including information regarding a temperature rate change of the cryogenic fluid within the patient.

16. An intravascular catheter system for treating a patient during an ablation procedure, the intravascular catheter system comprising:

a graphical display that is configured to display a set of data including information regarding a time to reach a target ablation temperature.

17. An intravascular catheter system for treating a patient during an ablation procedure, the intravascular catheter system comprising:

a graphical display that is configured to display a set of data including information regarding a target ablation temperature.

18. An intravascular catheter system for treating a patient during an ablation procedure, the intravascular catheter system comprising:

a graphical display that is configured to display a set of data including information regarding a time for a temperature to increase from an actual ablation temperature to a preset thaw temperature.

19. An intravascular catheter system for treating a patient during an ablation procedure, the intravascular catheter system comprising:

a graphical display that is configured to display a set of data including information regarding an actual ablation temperature.

20. An intravascular catheter system for treating a patient during an ablation procedure, the intravascular catheter system comprising:

a graphical display that is configured to display a summary of data including information regarding one or more ablation locations, a number of ablations at each location and a duration of each ablation at each location.

21 . An intravascular catheter system for treating a patient during an ablation procedure, the intravascular catheter system comprising:

a graphical display that is configured to display a set of data including information regarding a selection process for determination of an ablation location.

22. An intravascular catheter system for treating a patient during an ablation procedure, the intravascular catheter system comprising: a graphical display that is configured to display a set of data including information regarding a selection process to specify one or more of a target ablation temperature and an ablation location.

23. An intravascular catheter system for treating a patient during an ablation procedure, the intravascular catheter system comprising:

a fluid source that contains a cryogenic fluid that is delivered to the balloon catheter;

a controller that receives a compilation of data from the balloon catheter; and

a graphical display that receives the compilation of data from the controller, the graphical display being configured to display the compilation of data including information regarding at least three of (i) thoracic movement of the patient indicative of operation of a phrenic nerve of the patient, (ii) an esophageal temperature of the patient, (iii) a temperature rate change of the cryogenic fluid within the patient, (iv) a time to reach a target ablation temperature, (v) the target ablation temperature, (vi) a time for a temperature to increase from an actual ablation temperature to a preset thaw temperature, (vii) the actual ablation temperature, (viii) a summary that includes one or more ablation locations, a number of ablations at each location and a duration of each ablation at each location, (ix) a selection process for determining the ablation location, and (x) a selection process to specify one or more of the target ablation temperature and the ablation location.

24. The intravascular catheter system of claim 23 wherein the graphical display is configured to display the compilation of data including information regarding at least four of (i) thoracic movement of the patient indicative of operation of the phrenic nerve of the patient, (ii) the esophageal temperature of the patient, (iii) the temperature rate change of the cryogenic fluid within the patient, (iv) the time to reach the target ablation temperature, (v) the target ablation temperature, (vi) the time for the temperature to increase from the actual ablation temperature to the preset thaw temperature, (vii) the actual ablation temperature, (viii) the summary that includes the one or more ablation locations, the number of ablations at each location and the duration of each ablation at each location, (ix) the selection process for determining the ablation location, and (x) the selection process to specify one or more of the target ablation temperature and the ablation location.

25. The intravascular catheter system of claim 23 wherein the graphical display is configured to display the compilation of data including information regarding at least five of (i) thoracic movement of the patient indicative of operation of the phrenic nerve of the patient, (ii) the esophageal temperature of the patient, (iii) the temperature rate change of the cryogenic fluid within the patient, (iv) the time to reach the target ablation temperature, (v) the target ablation temperature, (vi) the time for the temperature to increase from the actual ablation temperature to the preset thaw temperature, (vii) the actual ablation temperature, (viii) the summary that includes the one or more ablation locations, the number of ablations at each location and the duration of each ablation at each location, (ix) the selection process for determining the ablation location, and (x) the selection process to specify one or more of the target ablation temperature and the ablation location.

26. The intravascular catheter system of claim 23 wherein the graphical display is configured to display the compilation of data including information regarding at least six of (i) thoracic movement of the patient indicative of operation of the phrenic nerve of the patient, (ii) the esophageal temperature of the patient, (iii) the temperature rate change of the cryogenic fluid within the patient, (iv) the time to reach the target ablation temperature, (v) the target ablation temperature, (vi) the time for the temperature to increase from the actual ablation temperature to the preset thaw temperature, (vii) the actual ablation temperature, (viii) the summary that includes the one or more ablation locations, the number of ablations at each location and the duration of each ablation at each location, (ix) the selection process for determining the ablation location, and (x) the selection process to specify one or more of the target ablation temperature and the ablation location.

27. The intravascular catheter system of claim 23 wherein the graphical display is configured to display the compilation of data including information regarding at least seven of (i) thoracic movement of the patient indicative of operation of the phrenic nerve of the patient, (ii) the esophageal temperature of the patient, (iii) the temperature rate change of the cryogenic fluid within the patient, (iv) the time to reach the target ablation temperature, (v) the target ablation temperature, (vi) the time for the temperature to increase from the actual ablation temperature to the preset thaw temperature, (vii) the actual ablation temperature, (viii) the summary that includes the one or more ablation locations, the number of ablations at each location and the duration of each ablation at each location, (ix) the selection process for determining the ablation location, and (x) the selection process to specify one or more of the target ablation temperature and the ablation location.

28. The intravascular catheter system of claim 23 wherein the graphical display is configured to display the compilation of data including information regarding at least eight of (i) thoracic movement of the patient indicative of operation of the phrenic nerve of the patient, (ii) the esophageal temperature of the patient, (iii) the temperature rate change of the cryogenic fluid within the patient, (iv) the time to reach the target ablation temperature, (v) the target ablation temperature, (vi) the time for the temperature to increase from the actual ablation temperature to the preset thaw temperature, (vii) the actual ablation temperature, (viii) the summary that includes the one or more ablation locations, the number of ablations at each location and the duration of each ablation at each location, (ix) the selection process for determining the ablation location, and (x) the selection process to specify one or more of the target ablation temperature and the ablation location.

29. The intravascular catheter system of claim 23 wherein the graphical display is configured to display the compilation of data including information regarding at least nine of (i) thoracic movement of the patient indicative of operation of the phrenic nerve of the patient, (ii) the esophageal temperature of the patient, (iii) the temperature rate change of the cryogenic fluid within the patient, (iv) the time to reach the target ablation temperature, (v) the target ablation temperature, (vi) the time for the temperature to increase from the actual ablation temperature to the preset thaw temperature, (vii) the actual ablation temperature, (viii) the summary that includes the one or more ablation locations, the number of ablations at each location and the duration of each ablation at each location, (ix) the selection process for determining the ablation location, and (x) the selection process to specify one or more of the target ablation temperature and the ablation location.

30. The intravascular catheter system of claim 23 wherein the graphical display is configured to display the compilation of data including information regarding each of (i) thoracic movement of the patient indicative of operation of the phrenic nerve of the patient, (ii) the esophageal temperature of the patient, (iii) the temperature rate change of the cryogenic fluid within the patient, (iv) the time to reach the target ablation temperature, (v) the target ablation temperature, (vi) the time for the temperature to increase from the actual ablation temperature to the preset thaw temperature, (vii) the actual ablation temperature, (viii) the summary that includes the one or more ablation locations, the number of ablations at each location and the duration of each ablation at each location, (ix) the selection process for determining the ablation location, and (x) the selection process to specify one or more of the target ablation temperature and the ablation location.