Pressure relief feature for flushing rf balloon catheter

Abstract

The present invention is entitled "Pressure Release Feature for Flushable RF Balloon Catheter". An apparatus includes a catheter shaft assembly and an end effector positioned at a distal end of the catheter shaft assembly. The end effector includes a balloon, one or more electrodes positioned on the balloon, and a tip assembly positioned at a distal end of the balloon. The balloon defines an interior configured to receive fluid to inflate the balloon. The balloon is sized and configured to fit within a cardiovascular anatomy. The tip assembly includes a pressure release valve configured to transition between a sealed state and a pressure release state. In the sealed state, the pressure release valve is configured to prevent fluid from leaking out of the interior of the balloon via the pressure release valve. In the pressure release state, the pressure release valve is configured to provide a path for fluid to leak from the interior of the balloon via the pressure release valve.

Description

Background Technology

[0001] Cardiac arrhythmias, such as atrial fibrillation, occur when electrical signals are abnormally conducted in areas of cardiac tissue. Treatment protocols for these arrhythmias involve surgically interrupting the conduction pathways used for such signals. By selectively ablating cardiac tissue with energy (e.g., radiofrequency (RF) energy), it is possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another. The ablation process can provide a blockage of unwanted electrical pathways by forming an electrically insulating lesion or scar tissue that effectively blocks the communication of abnormal electrical signals across tissue.

[0002] In some procedures, catheters with one or more RF electrodes can be used to deliver ablation within the cardiovascular system. The catheter may be inserted into a major vein or artery (e.g., the femoral artery) and then advanced to position the electrodes within the heart or in cardiovascular structures adjacent to the heart (e.g., the pulmonary veins). One or more electrodes may be positioned to contact cardiac or other vascular tissue and then activated using RF energy to ablate the contacted tissue. In some cases, the electrodes may be bipolar. In other cases, a monopolar electrode may be used in conjunction with a grounding pad or other reference electrode in contact with the patient. Flushing may be used to absorb heat from the ablation components of the ablation catheter and to prevent blood clots from forming near the ablation site.

[0003] Examples of ablation catheters are described in the following: U.S. Publication No. 2013 / 0030426, entitled "Integrated Ablation System using Catheter with Multiple Irrigation Lumens," published January 31, 2013, the disclosure of which is incorporated herein by reference in its entirety; U.S. Publication No. 2017 / 0312022, entitled "Irrigated Balloon Catheter with Flexible Circuit Electrode Assembly," published November 2, 2017, the disclosure of which is incorporated herein by reference in its entirety; and U.S. Patent No. 10,130,422, entitled "Catheter with Soft Distal Tip for Mapping and Ablating Tubular Region," published November 20, 2018, the disclosure of which is incorporated herein by reference in its entirety.

[0004] Some catheter ablation procedures can be performed after electrophysiological (EP) mapping to identify tissue areas that should be targeted for ablation. Such EP mapping may involve the use of sensing electrodes on a catheter (e.g., the same catheter used to perform the ablation or a dedicated mapping catheter). These sensing electrodes monitor electrical signals emanating from conductive endocardial tissue to precisely locate the site of abnormally conductive tissue leading to arrhythmias. Examples of EP mapping systems and catheters are described in the various references cited herein.

[0005] In addition to force sensing or EP mapping, some catheter ablation procedures can be performed using image-guided surgery (IGS) systems. IGS systems allow physicians to visually track the catheter's position within the patient's body in real time, relative to images of the patient's anatomy. Some systems offer a combination of EP mapping and IGS functionality, including those provided by Biosense Webster, Inc. of Irvine, California. Examples of conduits constructed for use with IGS systems are disclosed in the various references cited herein.

[0006] Although several surgical systems and methods have been manufactured and used, it is believed that no one prior to the inventors had prepared or used the invention described in the appended claims. Attached Figure Description

[0007] The following figures and detailed descriptions are intended to be illustrative only and are not intended to limit the scope of the invention as contemplated by the inventors.

[0008] Figure 1 A schematic diagram illustrates a medical procedure for inserting a catheter assembly into a patient's body.

[0009] Figure 2A It shows Figure 1 Top plan view of the catheter assembly, wherein the sheath covers the end actuator of the catheter assembly;

[0010] Figure 2B It shows Figure 1 A top plan view of the catheter assembly, wherein the end effector is exposed relative to the sheath, and wherein the end effector is in a non-expanded state;

[0011] Figure 2C It shows Figure 1 A top plan view of the catheter assembly, wherein the end effector is exposed relative to the sheath, and wherein the end effector is in an expanded state;

[0012] Figure 3 It shows Figure 1A perspective view of the end actuator of the conduit assembly;

[0013] Figure 4 It shows Figure 3 Exploded perspective view of the tip assembly of the end effector;

[0014] Figure 5 It shows Figure 4 An exploded perspective view of the components of the tip assembly;

[0015] Figure 6 It shows along Figure 3 The line 6-6 was cut Figure 4 Cross-sectional view of the tip component;

[0016] Figure 7A It shows along Figure 3 The line 7-7 was cut Figure 4 A cross-sectional view of the tip component, wherein the tip component is in a sealed state;

[0017] Figure 7B It shows along Figure 3 The line 7-7 was cut Figure 4 A cross-sectional view of the tip component, wherein the tip component is in a ventilated state;

[0018] Figure 8 It shows that it can be combined with Figure 1 A perspective view of an alternative end effector in the conduit assembly;

[0019] Figure 9 It shows Figure 8 Exploded perspective view of the tip assembly of the end effector;

[0020] Figure 10A It shows along Figure 8 The line cut from 10-10 Figure 9 A cross-sectional view of the tip component, wherein the tip component is in a sealed state; and

[0021] Figure 10B It shows along Figure 8 The line cut from 10-10 Figure 9 A cross-sectional view of the tip component, wherein the tip component is in a ventilated state. Detailed Implementation

[0022] The following description of certain examples of the invention is not intended to limit the scope of the invention. The accompanying drawings (not necessarily drawn to scale) illustrate selected embodiments and are not intended to limit the scope of the invention. The detailed description illustrates the principles of the invention by way of example and not by way of limitation. Other examples, features, aspects, embodiments, and advantages of the invention will be apparent to those skilled in the art from the following description, which is shown by way of example, and a preferred mode is contemplated for carrying out the invention. It will be appreciated that the invention can have other different or equivalent aspects, all of which do not depart from the invention. Therefore, the drawings and description should be considered substantially illustrative and not restrictive.

[0023] Any one or more of the teachings, expressions, types, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, types, examples, etc. Therefore, the following teachings, expressions, types, examples, etc., should not be considered separate from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art, referring to the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0024] As used herein, the terms “generally,” “substantially,” “about,” or “approximately” for any numerical or numerical range indicate that a portion or collection of multiple components is permitted to perform suitable dimensional tolerances for their intended purpose as described herein. More specifically, “about” or “approximately” can refer to a range of enumerated values ​​±20%, for example, “about 90%” can refer to a range of values ​​from 71% to 99%. Additionally, as used herein, the terms “patient,” “host,” “user,” and “subject” refer to any human or animal subject and are not intended to limit the system or method to human use, but the use of the subject matter invention in human patients represents a preferred embodiment.

[0025] I. Overview of examples of catheter systems

[0026] Figure 1 Examples of medical procedures and associated components for cardiac mapping or ablation systems are shown. Specifically, Figure 1 The image shows the handle (110) of the catheter assembly (100) being gripped by a physician (PH), wherein the end actuator (200) of the flexible catheter (120) of the catheter assembly (100) is located in... Figures 2A to 7B Shown but not in Figure 1 (As shown in the image) This is placed inside the patient (PA) to map or ablate tissue within or near the patient's (PA) heart (H). For example... Figures 2A to 2CAs shown, the conduit (120) includes an outer shaft (122) and an outer sheath (140) operable to selectively cover and expose an end effector (200), the outer sheath being disposed at the distal end (124) of the outer shaft (122). In some embodiments, a shank (110) includes an actuator (not shown) operable to translate the sheath (140) relative to the end effector (200) and the outer shaft (122). In some other embodiments, the shank (110) includes an actuator (not shown) operable to translate the end effector (200) and the outer shaft (122) relative to the sheath (140). The conduit (120) of this example also includes an inner shaft (150) extending through the end effector (200) (in... Figures 7A to 7B (shown in dashed lines). The inner shaft (150) defines an inner lumen (152) which is configured to slidably receive another instrument such as a guidewire or other catheter.

[0027] In some alternative configurations, instead of the sheath (140) being an integral part of the catheter (120), the sheath (140) may be part of a separate guiding sheath device, such that the catheter (120) and the end effector (200) are inserted through the guiding sheath device to position the end effector (200) at the appropriate location within the patient (PA).

[0028] The conduit assembly (100) is coupled to the guiding and actuation system (10) via a cable (30). In this example, the plug (not shown) of the cable (30) is configured to insert into a socket (130) of the handle assembly (110), which... Figures 2A to 2BThe example guide and drive system (10) includes a console (12) and a display (18). The console (12) includes a first drive module (14) and a second drive module (16). The first drive module (14) is coupled to the catheter assembly (100) via a cable (30). In some variations, the first drive module (14) is operable to receive EP mapping signals obtained via an electrode pair (not shown) of an end effector (200), as described in more detail below. The console (12) includes a processor (not shown) that processes such EP mapping signals to provide EP mapping as known in the art. In addition or alternatively, the first drive module (14) may be operable to provide RF power to the ablation electrode (214) of the end effector (200) to ablate tissue, as will also be described in more detail below. In some configurations, the first driver module (14) is also operable to receive position indication signals from one or more position sensors (206) in the end effector (200), as will also be described in more detail below. In this configuration, the processor of the console (12) is also operable to process the position indication signals from the position sensors (206) to determine the position of the end effector (200) within the patient (PA).

[0029] A set of field generators (20) is positioned below the patient (PA) and is also coupled to the guidance and drive system (10) via a cable (22). Specifically, a second drive module (16) is coupled to the field generators (20) via the cable (22). The second drive module (16) is operable to activate the field generators (20) to generate an alternating magnetic field around the heart (H) of the patient (PA). For example, the field generators (20) may include coils that generate the alternating magnetic field within a predetermined working volume accommodating the heart (H).

[0030] The display (18) is coupled to the processor of the console (12) and is operable to present images of the patient's anatomy. Such images may be based on a set of images obtained before or during surgery (e.g., CT or MRI scans, 3D mapping, etc.). The view of the patient's anatomy provided by the display (18) may also change dynamically based on signals from the position sensor (206) of the end effector (200). For example, as the end effector (200) moves within the patient (PA), corresponding position data from the position sensor (206) may enable the processor of the console (12) to update the view of the patient's anatomy in the display (18) in real time to depict the area of ​​the patient's anatomy around the end effector (200) as the end effector (200) moves within the patient (PA). Furthermore, the processor of the console (12) may drive the display (18) to display the location of abnormally conductive tissue sites, such as those detected by EP mapping using the end effector (200). By way of example only, the processor of the console (12) can drive the display (18) to overlay the location of the abnormally conductive tissue site onto an image of the patient's anatomy with some other form of visual indication, such as by overlaying illuminated points, crosshairs, or abnormally conductive tissue sites.

[0031] The processor of the console (12) can also drive the display (18) to overlay the current position of the end effector (200) onto an image of the patient's anatomy, such as by overlaying illuminated points, crosshairs, a graphical representation of the end effector (200), or some other form of visual indication. Such overlaid visual indications can also move within the image of the patient's anatomy on the display (18) as the physician moves the end effector (200) within the patient (PA), thus providing the operator with real-time visual feedback on the position of the end effector (200) within the patient (PA) as it moves within the patient (PA). Therefore, the image provided by the display (18) can effectively provide video tracking of the position of the end effector (200) within the patient (PA) without necessarily having any optical instruments (i.e., cameras) for viewing the end effector (200). In the same view, the display (18) can simultaneously visually indicate the location of anomalously conductive tissue sites detected by EP mapping as described herein. Therefore, the physician (PH) can view the display (18) to observe the real-time positioning of the end effector (200) relative to the mapped abnormal conductive tissue sites and relative to images of adjacent anatomical structures within the patient (PA).

[0032] The conduit assembly (100) is coupled to a fluid source (42) via a fluid conduit (40). The fluid conduit (40) is configured to be coupled to the fluid inlet (130) of the handle assembly (110), which in Figures 2A to 2CAs shown in the figure. Such coupling can be achieved using conventional Luer fittings or any other suitable type of coupling. The fluid source (42) in this example includes a bag containing saline or some other suitable flushing fluid. The conduit (40) includes a flexible tube that is also coupled to a pump (44) operable to selectively drive fluid from the fluid source (42) to the catheter assembly (100). In some variations, the conduit (40), fluid source (42), and pump (44) are omitted entirely. In forms that include these components, an end effector (200) may be configured to deliver flushing fluid from the fluid source (42) to a target site within the patient's body. Such flushing may be provided in accordance with the teachings of any of the various patent references cited herein; or in any other suitable manner that will be apparent to a person skilled in the art who has referenced the teachings herein.

[0033] II. Examples of End Actuators

[0034] Figure 3 The end effector (200) of this example is shown in more detail. As shown, the end effector (200) includes an inflatable balloon (202) and a set of electrode assemblies (210) spaced angularly from each other around the balloon (202). The balloon (202) is operable to be in an uninflated state ( Figures 2A to 2B ) and expansion state ( Figures 2C to 3 and Figures 7A to 7B The balloon (202) can be inflated with flushing fluid (e.g., saline) from a fluid source (42), wherein a pump (44) applies pressure to the fluid to transition from an inflated state to an inflated state. In the inflated state, the balloon (202) can fit within a sheath (140). In the inflated state, the balloon (202) can be sized and configured to push the electrodes (214) of the electrode assembly (210) into contact with tissue (e.g., the inner wall of a pulmonary vein or a chamber of the heart (H)). In this example, the balloon (202) is formed of a flexible but non-stretchable material.

[0035] The balloon (202) in this example includes multiple openings (204). Although Figure 3 Only a few openings (204) are shown, but the balloon (202) can actually have a large number of openings. The openings (204) can be large enough to allow fluid to leak through the balloon (202) to the site where the electrode assembly (210) is ablating tissue; while also being small enough to allow the balloon (202) to inflate in response to pressurized fluid being delivered to its interior. By way of example only, the diameter of the opening (204) can be approximately 0.0035 inches. Alternatively, the opening (204) can be any other suitable size, including but not limited to diameters ranging from approximately 0.0100 inches to approximately 0.0010 inches.

[0036] Each electrode assembly (210) in this example includes a flexible substrate (212) and an electrode (214). The substrate (212) and the electrode (214) may be formed as a flexible circuit. The sides of each substrate (212) are defined by longitudinally extending crossbeams (224). Each longitudinally extending crossbeam (224) is also coupled to a central latitude crossbeam (220) and a distal latitude crossbeam (222). In some configurations, the crossbeams (220, 222, 224) facilitate securing the electrode assembly (210) to the balloon (202). Alternatively, the crossbeams (220, 222, 224) may engage other components of the end effector (200). In some configurations, the crossbeams (220, 222, 224) are defined by filler edges of an adhesive. Although the electrode assembly (210) is shown positioned only on the distal side of the central latitude beam (220), some configurations of the end effector (200) may include an electrode assembly (210) located on the proximal side of the central latitude beam (220). Furthermore, the depicted configurations and arrangements of the beams (220, 222, 224) are merely illustrative examples. The beams (220, 222, 224) may be reconfigured, repositioned, supplemented, replaced, or omitted as needed.

[0037] The electrode (214) of this example is operable to ablate tissue in contact with the electrode (214). Each electrode (214) of this example includes a central elongated portion or ridge from which a plurality of fingers extend laterally. Thus, each electrode (214) has a herringbone configuration. With such a herringbone configuration, the fingers of each electrode (214) can advantageously increase the circumferential or equatorial contact surface between the electrode (214) and the target tissue, while the gaps between adjacent fingers of the electrode (214) can advantageously allow the balloon (202) to collapse inward and / or expand radially as needed at a location along its equator. In some types, the fingers of each electrode (214) have different lengths, some longer and others shorter. For example, the fingers of each electrode (214) may have a gradually decreasing length along the central ridge of the electrode (214), thereby providing a generally conical configuration for each electrode (214). The electrode (214) may be further constructed and operated based on at least some of the teachings of U.S. Publication No. 2017 / 0312022 entitled “Irrigated Balloon Catheter with Flexible Circuit Electrode Assembly”, published on November 2, 2017, the disclosure of which is incorporated herein by reference in its entirety.

[0038] In some configurations, the electrode (214) is configured to provide both RF ablation and EP mapping functions. In some other configurations, the electrode (214) is configured to provide only RF ablation without EP mapping. In other configurations, the electrode (214) is configured to provide only EP mapping without RF ablation. As yet another illustrative example, the end effector (200) may include some electrodes (214) dedicated to providing only RF ablation and others dedicated to providing only EP mapping. Other suitable configurations and functions that may be associated with the electrode (214) will be apparent to those skilled in the art from the teachings herein.

[0039] In some types of ablation catheters (120) that include electrodes (214) specifically designed for RF ablation only and other electrodes specifically designed for EP mapping only, the distal region of the end effector (200) may include an electrode specifically for EP mapping. Such an EP mapping electrode may be positioned distal to the electrode (214). Such an EP mapping electrode may be isolated relative to the electrode (214). Prior to RF ablation, such an EP mapping electrode may be used to help identify the target area for RF ablation. After RF ablation, such an EP mapping electrode may also be used to verify whether the RF ablation was adequate. Furthermore, such an EP mapping electrode may monitor ECG signals in real time during RF ablation to provide real-time feedback on the effectiveness of the RF ablation.

[0040] The end effector (200) of this example also includes a distal hub (230) having an integral, distally extending cylindrical member (232). Referring to the teachings herein, the distal hub (230) can be attached to the balloon (202) in any suitable manner as will be apparent to those skilled in the art. As noted above, the end effector (200) also includes a position sensor (206). Figures 3 to 4 The position sensor (206) is schematically integrated into the cylindrical member (232) of the distal hub (230). Alternatively, the end effector (200) may include one or more position sensors (206) located at any other suitable location, in addition to or replacing the position sensor (206) included in the cylindrical member (232).

[0041] A position sensor (206) is operable to generate a signal indicating the position and orientation of the end effector (200) within the patient (PA). By way of example only, the position sensor (206) may be in the form of a coil or multiple coils (e.g., three orthogonal coils) configured to generate an electrical signal in response to the presence of an alternating electromagnetic field generated by a field generator (20). The position sensor (206) may be coupled along or otherwise through a conduit (120) to a wire, trace, or any other suitable electrical conduit, such that the signal generated by the position sensor (206) can be transmitted back to the console (12) via an electrical conduit (not shown) in the conduit (120). The console (12) may process the signal from the position sensor (206) to identify the position of the end effector (200) within the patient (PA). Other components and techniques that may be used to generate real-time position data associated with the end effector (200) may include wireless triangulation, acoustic tracking, optical tracking, inertial tracking, etc. In some models, the position sensor (206) may be omitted. As another example, the position sensor (206) may be integrated into another instrument (e.g., a guidewire or catheter, etc.) that is slidably disposed in the lumen (152) of the inner shaft (150).

[0042] During use of the catheter assembly (100), when the catheter (120) is introduced into the patient (PA) and during the transition from the insertion site to the targeted cardiovascular region within the patient (PA), the catheter (120), sheath (140), and end effector (200) may be in a position Figure 2A The state is shown. Once the catheter (120), sheath (140), and end effector (200) are properly positioned near the target cardiovascular structure, the sheath (140) can be retracted relative to the end effector (200) (or the end effector (200) can be advanced relative to the sheath (140)) to achieve Figure 2BThe state is shown. The end effector (200) can then be expanded by inflating the balloon (202) to bring the electrode (214) into contact with the tissue of the target cardiovascular structure. After the electrode (214) is in contact with the target tissue, the electrode (214) can then be activated to apply RF energy to the tissue, thereby ablating the tissue. RF energy can be supplied from the console (12) via various components that electrically couple the electrode (214) to the console (12) as described above. The end effector (200) can then be collapsed into a non-inflated configuration by deflating the balloon (202). The catheter (120), sheath (140), and end effector (200) can then be removed from the patient (PA). During at least some of the steps described above, the physician (PA) can observe the display (18) to view the real-time position of the end effector (200) and / or other components of the catheter assembly (100) based on position data from the position sensor (206).

[0043] In addition to the foregoing, the end effector (200) and other aspects of the catheter assembly (100) may be configured and operated in accordance with at least some of the teachings of U.S. Publication No. 2017 / 0312022 entitled “Irrigated Balloon Catheter with Flexible Circuit Electrode Assembly”, published November 2, 2017, the disclosure of which is incorporated herein by reference in its entirety.

[0044] A. An example of a flexible O-ring as a safety valve

[0045] As noted above, the balloon (202) can be inflated with inflation fluid leaking from the balloon (202) through the opening (204). When the ablation or mapping procedure is completed and the physician (PH) wishes to return the balloon (202) to an uninflated state and remove the end effector (202) from the patient (PA), the physician can stop fluid delivery to the balloon (202). The balloon (202) can then be deflated as fluid leaks through the opening (204). Figure 2BThe non-inflated state shown allows the physician (PH) to position the end effector (200) back into the sheath (140) and withdraw the catheter (120) and end effector (200) from the patient (PA). If the physician (PA) is unable to provide sufficient time for fluid to leak out through the opening (204) in a manner sufficient to achieve complete venting of the balloon (202), complications may arise when attempting to position the end effector (200) in the sheath (140) or otherwise attempt to remove the end effector (200) from the patient (PA). Therefore, it may be desirable to provide features that provide additional pressure relief to the balloon (202) during the venting phase. For this purpose, the end effector (200) of this example includes a tip assembly (250) configured to provide additional pressure relief to the balloon (202) during the venting phase.

[0046] like Figures 4 to 7B As shown, the tip assembly (250) of this example includes a body (252) having a distal annular flange portion (254) and a proximal cylindrical portion (256). The cylindrical portion (256) has an outer diameter whose dimensions are configured such that the cylindrical portion (256) can fit into the cylindrical member (232) of the distal hub (230), such as Figure 3 As shown. With the cylindrical portion (256) of the body (252) fully inserted into the cylindrical member (232) of the distal hub (230), the body (252) can be bonded to the cylindrical member (232) of the distal hub (230) by interference fit, adhesive or epoxy resin, welding, or any other suitable technique that will be apparent to those skilled in the art as described herein. The flange portion (254) is sized to be larger than the cylindrical member (232) of the distal hub (230) such that the flange portion (254) is positioned distal to the cylindrical member (232) of the distal hub (230), while the cylindrical portion (256) of the body (252) sits within the cylindrical member (232) of the distal hub (230), as also as Figure 3 As shown.

[0047] The hole (270) extends along the entire length of the body (252) through the flange portion (254) and the cylindrical portion (256), making the body (252) hollow. The diameter of the hole (270) passing through the cylindrical portion (256) is larger than the diameter of the hole (270) passing through the flange portion (254). Figures 7A to 7BAs shown, the inner annular shoulder (280) provides a stepped transition from the region of the hole (270) in the cylindrical portion (256) to the region of the hole (270) in the flange portion (254). The dimensions of the region of the hole (270) in the cylindrical portion (256) are set to the inner axis (150) of the receiving conduit (120), as... Figures 6 to 7B As shown. The diameter of the hole (270) through the flange portion (254) is smaller than the outer diameter of the inner shaft (150), such that the inner shaft (150) will not fit within the area of ​​the hole (270) in the flange portion (254). Therefore, when the inner shaft (150) is fully inserted into the hole (270), the distal end of the inner shaft (150) abuts the shoulder (280). With the inner shaft (150) fully inserted into the hole (270), the inner shaft (150) can be bonded to the body (252) by interference fit, using adhesive or epoxy resin, by welding, or by any other suitable technique that will be apparent to those skilled in the art as described herein. Figures 7A to 7B As shown, the area of ​​the hole (270) in the flange portion (254) is aligned with the lumen (152) of the inner shaft (150), allowing instruments (e.g., guidewires, EP mapping catheters, etc.) to pass through the lumen (152) and the area of ​​the hole (270) in the flange portion (254) for distal positioning relative to the tip assembly (250) if necessary. This is not necessary in all types.

[0048] The cylindrical portion (254) defines a plurality of lateral openings (257) communicating with the hole (270). In this example, the openings (257) are staggered relative to each other longitudinally and at an angle along the cylindrical portion (254), but the openings (257) may have any other suitable positioning along the cylindrical portion (254). In some types, the openings (257) are used to hold adhesive, epoxy resin, or some other material for bonding the inner shaft (150) to the body (252). In other words, the openings (257) may serve as adhesive drainage holes. In some other types, the openings (257) are omitted.

[0049] The body (252) also defines two longitudinally extending recesses (258) extending along the hole (270) in the cylindrical portion (254). In this example, the recesses (258) are offset from each other at an angle of 180 degrees. In other types, a single recess (258) or more than two recesses (258) may be used. The recesses (258) may also be arranged along the hole (270) in any other suitable manner. In this example, the recesses (258) and the opening (257) are offset from each other at an angle such that the opening (257) does not pass through the recesses (258). Figures 6 to 7BAs best shown, when the inner shaft 150 is positioned in the region of the hole (270) in the cylindrical portion (256), the channel (290) is defined between the recess (258) and the outer diameter of the inner shaft (150). Figures 7A to 7B As shown, these channels (290) are in fluid communication with the interior of the balloon (202), such that the channels (290) provide a pathway for draining fluid from the balloon (202), as described in more detail below.

[0050] The body (252) also includes an annular recess (262) positioned between the annular flange portion (252) and the cylindrical portion (254). The recess (262) includes a pair of lateral openings (264). Each opening 264 is located at the distal end of a corresponding recess in the recess (258), such that each recess (258) is in fluid communication with the corresponding opening (258). The size and position of each opening (264) are also configured to be in fluid communication with a corresponding channel (290), wherein the inner shaft (150) is seated in the region of the hole (270) in the cylindrical portion (256). The recess (262) is sized to receive an O-ring (260). The size and configuration of the O-ring (260) are configured such that the O-ring (260) is elastically biased to sit tightly in the recess (262), as Figure 3 and Figure 7A As shown. However, the O-ring (260) is also configured to expand radially outward in response to sufficient fluid pressure impacting the O-ring (260), as... Figure 7B As shown and as described in more detail below. Figure 3 and Figures 7A to 7B As shown, with the cylindrical portion (256) of the body (252) fully seated within the cylindrical member (232) of the distal hub (230), the O-ring (260) is longitudinally positioned between the flange portion of the body (254) and the distal end of the cylindrical member (232) of the distal hub (230). Although an O-ring (260) is used in this example, any other suitable type of sealing member can be used in place of the O-ring (260), including but not limited to annular strips or structures with a flat cross-sectional profile. Other suitable types of sealing members will be apparent to those skilled in the art from the teachings herein.

[0051] Figure 7AThe tip assembly (250) during normal operation of the end effector (200) is shown. As shown, the elasticity of the O-ring (260) provides a tight fit between the O-ring (260) and the opening (264) in the recess (262). In this state, the O-ring (260) prevents fluid from escaping from the interior of the balloon (202) via the channel (290) and the opening (264). Therefore, as the balloon (202) inflates and presses against the tissue to push the electrode (214) against the tissue, the O-ring (290) continues to seal the opening (264), so that fluid will leave the balloon (202) only through the opening (204).

[0052] As noted above, when the physician (PH) wishes to deflate the balloon (202) at the end of the procedure by stopping the delivery of fluid to the balloon (202), the fluid remaining in the balloon (202) may not leak out through the opening (204) as quickly as the physician (PH) might expect. In such scenarios, the physician's (PH) efforts to position the end effector (200) within the sheath (140) or otherwise attempt to remove the end effector (200) from the patient (PA) before sufficient fluid has leaked from the balloon (202) may result in a pressure spike in the fluid remaining in the balloon (202). In such cases, the fluid pressure spike can drive the O-ring (260) to expand radially outward, as... Figure 7B As shown. When the O-ring (260) expands radially outward to... Figure 7B In the indicated state, the O-ring (260) expands outward away from the central longitudinal axis (LA) of the conduit (120) and the end effector (200), wherein the central longitudinal axis (LA) is in Figure 3 As shown in the image.

[0053] When the O-ring (260) is in Figure 7B In the outwardly inflated state shown, gaps (292) are defined between the O-ring (260) and the recess (262). These gaps (292) provide a pathway for fluid to leak out of the balloon (202) via the channel (290), the opening (264), and the gaps (292). Therefore, the O-ring (260) provides a safety valve to assist in the drainage of the balloon (202) when the pressure of the fluid in the balloon (202) reaches its peak. Once the fluid pressure has been released, the elasticity of the O-ring (260) will cause the O-ring (260) to return to its original position. Figure 7A The state shown. The end effector (200) can then be removed from the patient (PA).

[0054] In some configurations, the O-ring (260) may be configured to respond to a fluid pressure within the balloon (202) exceeding a pressure threshold in the range of approximately 1.50 psi to approximately 8.00 psi. Figure 7A The shrinkage of the sealed state changes to Figure 7B The pressure release state of the expansion. Alternatively, the O-ring (260) can exhibit any other suitable pressure threshold.

[0055] B. Example of an end actuator with a spring-loaded safety valve

[0056] Figures 8 to 10B An example of another end effector (300) that can be incorporated into the catheter assembly (100) to replace the end effector (200) is shown. This example end effector (300) is substantially the same as the end effector (200) unless otherwise described below. Similar to the end effector (200), this example end effector (300) includes a balloon (302) with an opening (304), an electrode assembly (310) with a substrate (312) and electrodes (314), crossbeams (320, 322, 324), and a distal hub (330) with a distally extending cylindrical member (332) and a position sensor (306). These components of the end effector (300) are constructed and operable in the same manner as similarly named components of the end effector (200), so details of these components will not be repeated here.

[0057] The end effector (300) in this example also includes a distal tip assembly (350) configured differently from the tip assembly (250) of the end effector (200), but the tip assembly (350) is operable to provide a pressure relief valve to the balloon (302). Figure 9 Best viewed, the tip assembly (350) of this example includes a distal annular member (352), an O-ring (360), a first cylindrical body (354), and a second cylindrical body (370). The distal annular member (352) defines a central opening (353). The first cylindrical body (354) defines a grooved hole (356) comprising a plurality of longitudinally extending recesses spaced at an angle. The second cylindrical body (370) also defines a hole (372). An annular flange (382) is securely fixed near the proximal end of the second cylindrical body (370) (e.g., via adhesive, welding, etc.). A wave spring (380) is positioned around the exterior of the second cylindrical body (370).

[0058] The second cylindrical body (370) is slidably disposed within the grooved hole (356) of the first cylindrical body (354). Figures 10A to 10BAs shown, the grooved configuration of the orifice (356) provides longitudinally extending gaps (390) between the outer diameter of the second cylindrical body (370) and each groove recess defined in the orifice (356). These longitudinally extending gaps (390) provide pathways for the drainage of fluid from the balloon (302), as described in more detail below.

[0059] like Figure 8 and Figures 10A to 10B As shown, the first cylindrical body (354) is configured to fit within the cylindrical member (332) of the distal hub (330). Furthermore, the first cylindrical body (354) is bonded to the cylindrical member (332) of the distal hub (330). This bonding can be accomplished by interference fit, using adhesives or epoxy resin, by welding, or by any other suitable technique that will be apparent to those skilled in the art as described herein. Figures 10A to 10B Ideally, the distal annular member (352) is securely attached to the distal end of the second cylindrical body (370). By way of example only, the distal annular member (352) may be attached to the distal end of the second cylindrical body (370) by interference fit, by use of adhesive or epoxy resin, by use of welding, or by use of any other suitable technique that will be apparent to those skilled in the art as described herein with reference to the teachings herein.

[0060] Similarly, Figures 10A to 10B As shown, the inner axis (150) of the catheter (120) (in) Figures 10A to 10B (Shown in dashed lines) is disposed in a hole (372) in the second cylindrical body (370). In some embodiments, the inner shaft (150) is securely attached to the second cylindrical body (370) by means of an interference fit, the use of an adhesive or epoxy resin, welding, or any other suitable technique, as will be apparent to a person skilled in the art with reference to the teachings herein. Alternatively or otherwise, the distal end of the inner shaft (150) may be securely attached to the distal annular member (352) (e.g., by means of an adhesive or epoxy resin, welding, or any other suitable technique, as will be apparent to a person skilled in the art with reference to the teachings herein). In some variations, the coupling between the inner shaft (150) and the second cylindrical body (370) or the distal annular member (352) allows at least some degree of relative longitudinal movement between the inner shaft (150) and the combination of the second cylindrical body (370) and the distal annular member (352). In some of these variations, although such relative longitudinal movement is permitted, it may be subject to one or more restrictive structures that will be apparent to those skilled in the art as to the teachings herein.

[0061] In this example, the lumen (152) of the inner shaft (150) is aligned and communicates with the central opening (353) of the distal annular member (352). Therefore, if needed, instruments (e.g., guidewires, EP mapping catheters, etc.) can pass through the lumen (152) and the central opening (353) to be positioned distally relative to the tip assembly (350). This is not necessary in all configurations.

[0062] like Figures 10A to 10B As shown, the longitudinal distance between the annular flange (382) and the distal annular member (352) is greater than the length of the first cylindrical body (354). This relative dimensional arrangement allows the wave spring (380) to be captured between the annular flange (382) and the proximal end of the first cylindrical body (354). This relative dimensional arrangement also allows the O-ring (360) to be captured between the distal end of the cylindrical member (332) and the distal annular member (352). Furthermore, this relative dimensional arrangement allows the first cylindrical body (354) to allow a certain degree of longitudinal movement relative to the combination of the annular flange (382), the second cylindrical body (370), and the distal annular member (352).

[0063] A wave spring (380) is configured to support the distal end of the first cylindrical body (354) against its proximal end, thereby elastically biasing the distal end of the cylindrical member (332) into engagement with the O-ring (360). By way of example only, the wave spring (380) may be configured to elastically bias the distal end of the cylindrical member (332) into engagement with the O-ring (360) under a load ranging from approximately 0.5 ft.-lb. to approximately 1.5 ft.-lb. When the distal end of the cylindrical member (332) engages with the O-ring (360), as Figure 10A As shown, the distal end of the cylindrical member (332) and the O-ring (360) cooperate to seal the distal end of the longitudinally extending gap (390) defined between the outer diameter of the second cylindrical body (370) and each recess defined in the hole (356). Therefore, when the tip assembly (350) is in Figure 10A In the indicated state, the distal end of the cylindrical member (332) and the O-ring (360) cooperate to prevent the inflation fluid in the balloon (302) from leaking out through the tip assembly (350). The wave spring (380) will hold the tip assembly (350) in place during normal operation of the end effector (300). Figure 10A The state shown. In this state, when the balloon (302) inflates and presses against the tissue to push the electrode (314) against the tissue, fluid will leave the balloon (302) only through the opening (304).

[0064] As noted above, when the physician (PH) wishes to deflate the balloon (302) at the end of the procedure by stopping the delivery of fluid to the balloon (302), the fluid remaining in the balloon (302) may not leak out through the opening (304) as quickly as the physician (PH) might expect. In such scenarios, the physician's (PH) efforts to position the end effector (300) within the sheath (140) or otherwise attempt to remove the end effector (300) from the patient (PA) before sufficient fluid has leaked from the balloon (302) may result in a pressure spike in the fluid remaining in the balloon (302). In such cases, the fluid pressure spike could drive the cylindrical member (332) and the first cylindrical body (354) to translate proximally relative to the inner axis (150) and relative to the remainder of the tip assembly (350), such as Figure 10B As shown. In this state, proximal movement of the cylindrical member (332) and the first cylindrical body (354) relative to the remainder of the tip assembly (350) will provide separation between the O-ring (360) and the distal end of the cylindrical member (332), thereby defining a gap (392). In this example, the wave spring (380) will deform to allow proximal translation of the cylindrical member (332) and the first cylindrical body (354) relative to the inner axis (150) and relative to the remainder of the tip assembly (350). By way of example only, the wave spring (380) will deform in response to a load ranging from approximately 2.0 ft.-lb. to approximately 5.0 ft.-lb. Figure 10B The state shown. When the wave spring (380) deforms into Figure 10B In the indicated state, the wave spring (380) is compressed along the central longitudinal axis (LA) of the conduit (120) and the end effector (300), wherein the central longitudinal axis (LA) is in Figure 8 As shown in [the image]. Figure 10A The state shown and Figure 10B During the transition between the states shown, the first cylindrical body (354) translates relative to the rest of the tip assembly (350) along the central longitudinal axis (LA).

[0065] Even though the cylindrical member (332) and the first cylindrical body (354) are located in a proximal position relative to the rest of the tip assembly (350), such as Figure 10BAs shown, sufficient clearance will remain between the annular flange (382) and the proximal end of the first cylindrical body (354) to allow fluid to flow from the interior of the balloon (302) into the gap (390) defined between the outer diameter of the second cylindrical body (370) and each recessed portion defined in the orifice (356). The cylindrical member (332) and the tip assembly (350) will thus cooperate to provide a pathway for fluid to leak from the balloon (302) via the gaps (390, 392). Therefore, the tip assembly (350) provides a safety valve to assist in the drainage of the balloon (302) when the pressure of the fluid in the balloon (302) reaches its peak.

[0066] Once the fluid pressure has been released from the balloon (302), the elasticity of the wave spring (380) will cause the tip assembly (350) to return to its original position. Figure 10A The state shown. The end effector (300) can then be removed from the patient (PA).

[0067] In this example, the pressure peak of the fluid in the balloon (302) causes deformation of the wave spring (380), wherein such deformation provides proximal movement of the cylindrical member (332) and the first cylindrical body (354) relative to the remainder of the tip assembly (350) to define a gap (392). This causes the tip assembly (350) to move from a sealed state ( Figure 10A ) transition to pressure release state ( Figure 10B The fluid pressure threshold of the balloon (302) will be governed by the spring constant of the wave spring (380). By way of example only, the wave spring (380) may be configured to deform to provide a change in the state of the tip component (350) in response to the fluid pressure within the balloon (302) exceeding a pressure threshold in the range of approximately 1.50 psi to approximately 8.00 psi. Alternatively, the wave spring (380) may exhibit any other suitable pressure threshold.

[0068] Although a wave spring (380) is used in the foregoing example, other suitable structures may be used. By way of example only, the wave spring (380) may be replaced by a helical spring or a Bass spring. Other types of elastic components that may be used to replace the wave spring (380) will be apparent to those skilled in the art in light of the teachings herein. It should also be understood that the O-ring (360) is optional, especially when the distal surface of the first cylindrical body (354) will seal substantially directly against the proximal surface of the distal annular member (352).

[0069] C. Example of degassing process

[0070] The aforementioned tip assembly (250, 350) example is provided in the context of additional pressure release of the balloon (202, 302) during the operational phase of balloon (202, 302) deflation. Alternatively, the pressure-release characteristics of the tip assembly (250, 350) may also be advantageous in the event of balloon (202, 302) degassing. This operational phase may occur before the balloon (202, 302) and tip assembly (250, 350), etc., are inserted into the patient (PA). The degassing process may include flushing the balloon (202, 302) with saline or other liquid to remove air from the balloon (202, 302). In the form of balloon (202, 302) lacking the tip assembly (250, 350) as described herein, the purged air (and the final purging fluid) may simply escape from the balloon (202, 302) through the opening (204, 304). However, in the type of balloon (202) including the tip component (250), the purged air (and the final purge fluid) can leak out through the channel (290), opening (264), and gap (292) as described herein. Similarly, in the type of balloon (302) including the tip component (350), the purged air (and the final purge fluid) can leak out through the gaps (390, 392) as described herein.

[0071] During the degassing process using a balloon (202, 302) with tip components (250, 350), before inserting the end effector (200, 300) into the patient (PA), the physician (PH) may expose the balloon (202, 302) relative to the sheath (140), orient the balloon (202, 302) vertically, and activate the pump (44) to drive fluid from the fluid source (42) toward the balloon (202, 302). In some scenarios, the pump (44) is activated to drive the fluid at a flow rate higher than that which would normally be used during normal operation of the end effector (200, 300) when it is positioned in the patient (PH). By way of example only, this relatively high flow rate can be in the range of approximately 60 ml / min to approximately 100 ml / min. The physician (PH) can observe the end effectors (200, 300) when the pump (44) is activated to observe the bubbles escaping through the tip assembly (250, 350). Once the end effectors (200, 300) reach the point where the liquid flows steadily out through the tip assembly (250, 350), making it appear that all air has been effectively purged from the balloon (202, 302), the physician (PH) can horizontally orient the end effectors (200, 300) to confirm that the degassing process is effective.

[0072] Once the physician (PH) is certain that the degassing process is effective, the physician (PH) can deflate the balloon (202,302) by stopping the activation of the pump (44) and allowing all remaining fluid in the balloon (202,302) to escape. The physician (PH) can also position the end effector (200,300) within the sheath (140) such that the end effector (200,300) is completely contained within the sheath (140), as described above. The physician (PH) can then introduce the sheath (140), the end effector (200,300), and the distal portion of the catheter (120) into the patient (PH) and perform the EP mapping and / or cardiac ablation procedures described above.

[0073] III. Examples of Combinations

[0074] The following examples illustrate various non-exhaustive ways in which the teachings herein can be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claims that may be provided at any time in this patent application or a subsequent filing thereof. No disclaimer is intended. The following examples are provided merely for illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that some variations may omit certain features mentioned in the following examples. Therefore, none of the aspects or features mentioned below should be considered definitive unless otherwise expressly indicated, for example, by the inventor or a successor of the inventor of interest, at a later date. If any claim set forth in this patent application or a subsequent filing related to this patent application includes additional features beyond those mentioned below, such additional features should not be presumed to have been added for any reason related to patentability.

[0075] Example 1

[0076] An apparatus comprising: (a) a catheter shaft assembly having a distal end; and (b) an end effector positioned at the distal end of the catheter shaft assembly, the end effector comprising: (i) a balloon having a proximal end and a distal end, the balloon defining an interior configured to receive fluid to inflate the balloon, the balloon being sized and configured to fit within a cardiovascular anatomy; (ii) one or more electrodes located on the balloon; and (iii) a tip assembly located at the distal end of the balloon, the tip assembly including a pressure relief valve configured to switch between the sealed state and the pressure relief state, the pressure relief valve in the sealed state being configured to prevent fluid leakage from the interior of the balloon via the pressure relief valve, and the pressure relief valve in the pressure relief state being configured to provide a path for fluid leakage from the interior of the balloon via the pressure relief valve.

[0077] Example 2

[0078] According to the device of Embodiment 1, the pressure relief valve includes an elastic member configured to elastically bias the pressure relief valve to the sealing state.

[0079] Example 3

[0080] According to the device of Embodiment 2, the elastic member is configured to deform in response to the fluid pressure inside the balloon exceeding a pressure threshold, and the elastic member is operable to cause the pressure relief valve to change from the sealed state to the pressure-relieving state by the deformation of the elastic member.

[0081] Example 4

[0082] According to any one or more of the devices described in Embodiments 2 to 3, the elastic member has an annular shape.

[0083] Example 5

[0084] According to any one or more of the devices described in Embodiments 2 to 4, the elastic member includes an O-ring.

[0085] Example 6

[0086] According to any one or more of the devices described in Embodiments 2 to 5, the elastic member is configured to deform radially outward away from the central longitudinal axis defined by the end effector.

[0087] Example 7

[0088] According to any one or more of the devices described in Embodiments 2 to 4, the elastic member includes a wave spring.

[0089] Example 8

[0090] According to any one or more of embodiments 2 to 4 or 7, the elastic member is configured to deform along a central longitudinal axis defined by the end effector.

[0091] Example 9

[0092] According to any one or more of the devices described in Embodiments 1 to 8, the end effector further includes a cylindrical member located at the distal end of the balloon, and the tip assembly is coupled to the cylindrical member.

[0093] Example 10

[0094] According to the device of embodiment 9, the tip assembly includes a first cylindrical body disposed within the cylindrical member.

[0095] Example 11

[0096] According to the device of Embodiment 10, the first cylindrical body is firmly fixed relative to the cylindrical member.

[0097] Example 12

[0098] According to the device described in any one or more of Embodiments 10 to 11, the first cylindrical body includes at least one lateral opening configured to provide a path for fluid to leak from the interior of the balloon.

[0099] Example 13

[0100] The device according to embodiment 12 further includes an elastic member operable to selectively seal the at least one lateral opening, such that the elastic member and the at least one lateral opening cooperate to form the pressure relief valve.

[0101] Example 14

[0102] According to any one or more of the devices described in Embodiments 10 to 11, the tip assembly further includes a second cylindrical body slidably disposed within the first cylindrical body.

[0103] Example 15

[0104] According to the device of embodiment 14, the first cylindrical body and the second cylindrical body are configured to define a leakage path between the inner diameter region of the first cylindrical body and the outer diameter of the second cylindrical body.

[0105] Example 16

[0106] According to the device of embodiment 15, the inner diameter region of the first cylindrical body defines a plurality of grooves and recesses, which are collectively configured to provide the leakage path.

[0107] Example 17

[0108] According to any one or more of the devices described in Embodiments 14 to 16, the first cylindrical body is operable to translate relative to the second cylindrical body, thereby changing the pressure relief valve from the sealed state to the pressure relief state.

[0109] Example 18

[0110] According to any one or more of the devices described in Embodiments 10 to 17, the tip assembly further includes a first flange positioned on the distal side of the cylindrical member.

[0111] Example 19

[0112] According to the device of embodiment 18, the tip assembly further includes a second flange positioned proximal to the cylindrical member.

[0113] Example 20

[0114] According to any one or more of the devices described in Embodiments 1 to 19, the one or more electrodes include at least one electrode configured to sense potential in tissue.

[0115] Example 21

[0116] According to any one or more of the devices described in Examples 1 to 20, the one or more electrodes include at least one electrode configured to ablate tissue.

[0117] Example 22

[0118] According to any one or more of the devices described in Embodiments 1 to 21, the balloon further includes a plurality of openings configured to allow fluid to leak from the interior of the balloon while still allowing the balloon to reach an inflated state.

[0119] Example 23

[0120] The device according to any one or more of Embodiments 1 to 22 further includes a sheath that is slidably engaged with the catheter shaft assembly.

[0121] Example 24

[0122] According to the device of embodiment 23, the sheath is operable to translate relative to the catheter shaft assembly, thereby selectively covering and exposing the balloon.

[0123] Example 25

[0124] According to any one or more of the devices described in Embodiments 1 to 24, the end effector further includes a position sensor operable to generate a signal indicating the position of the end effector in three-dimensional space.

[0125] Example 26

[0126] According to any one or more of the devices described in Embodiments 1 to 25, the catheter shaft assembly includes an inner shaft that extends through the interior of the balloon.

[0127] Example 27

[0128] According to the device described in Embodiment 26, the inner shaft is fixed to the tip assembly.

[0129] Example 28

[0130] According to any one or more of embodiments 26 to 27, the inner shaft defines an inner cavity, the tip assembly defines a distal opening, and the inner cavity and the distal opening are configured to accommodate an instrument passing through the inner shaft and through the tip assembly.

[0131] Example 29

[0132] According to the device of embodiment 28, the lumen and the distal opening are isolated from the internal fluid of the balloon.

[0133] Example 30

[0134] An apparatus comprising: (a) a catheter shaft assembly having a distal end; and (b) an end effector positioned at the distal end of the catheter shaft assembly, the end effector comprising: (i) a balloon having a proximal end and a distal end, the balloon defining an interior configured to receive fluid to inflate the balloon, the balloon being sized and configured to fit within a cardiovascular anatomy; (ii) one or more electrodes located on the balloon; and (iii) a tip assembly located at the distal end of the balloon, the tip assembly comprising: (A) at least one opening; and (B) at least one elastic member configured to bias the tip assembly to provide the at least one opening in a closed state to prevent fluid leakage from the interior of the balloon via the at least one opening, the at least one elastic member being further configured to deform such that fluid can leak from the interior of the balloon via the at least one opening in response to a fluid pressure exceeding a threshold within the interior of the balloon.

[0135] Example 31

[0136] According to the device of embodiment 30, the elastic member is configured to selectively cover the at least one opening, and the elastic member is further configured to expand away from the at least one opening, thereby exposing the at least one opening.

[0137] Example 32

[0138] According to the device of embodiment 30, the tip assembly further includes: (A) a translational body, and (B) a sealing member coupled to the translational body, the sealing member being operable to selectively cover the at least one opening, the resilient member being positioned to resiliently push the translational body to drive the sealing member to cover the at least one opening, the resilient member being configured to allow the translational body and the sealing member to move when the resilient member reaches a deformed state, thereby exposing the at least one opening with the sealing member.

[0139] Example 33

[0140] A method includes: (a) positioning a balloon in a cardiovascular system; (b) inflating the balloon with fluid while it is positioned in the cardiovascular system; and (c) actuating a valve assembly located at a distal end of the balloon such that fluid leaks from the interior of the balloon via the valve assembly when the valve assembly is actuated.

[0141] Example 34

[0142] According to the method of embodiment 33, the actuation of the valve assembly includes providing a fluid pressure exceeding a pressure threshold inside the balloon, such that the valve assembly is actuated in response to the fluid pressure inside the balloon exceeding the pressure threshold.

[0143] Example 35

[0144] According to one or more of the methods described in Examples 33 to 34, the operation of the actuation valve assembly includes deforming the elastic member to open a fluid path located at the distal end of the balloon.

[0145] Example 36

[0146] According to any one or more of the methods described in Examples 33 to 35, the inflated balloon allows fluid to leak out through an opening formed in the balloon before performing the actuation of the valve assembly.

[0147] Example 37

[0148] The method according to any one or more of Examples 33 to 36 further includes contacting one or more electrodes on the balloon with tissue in the cardiovascular system.

[0149] Example 38

[0150] The method according to embodiment 37 further includes picking up a potential from the tissue via at least one of the one or more electrodes that are in contact with the tissue.

[0151] Example 39

[0152] The method according to any one or more of Examples 37 to 38 further includes ablating the tissue via at least one of the one or more electrodes that contact the tissue.

[0153] Example 40

[0154] The method according to any one or more of embodiments 33 to 39 further includes contacting the inflated balloon with the sheath, the contact between the inflated balloon and the sheath causing a peak fluid pressure inside the balloon, the peak fluid pressure causing actuation of the valve assembly.

[0155] IV. Miscellaneous

[0156] Any of the devices described herein may be cleaned and sterilized before and / or after the procedure. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic bag or a TYVEK bag. The container and device can then be placed in a radiation field that can penetrate the container, such as gamma radiation, X-rays, or high-energy electrons. The radiation kills bacteria on the device and in the container. The sterilized device can then be stored in a sterile container for later use. Any other techniques known in the art may also be used to sterilize the device, including but not limited to beta or gamma radiation, ethylene oxide, hydrogen peroxide, peracetic acid, and gas-phase sterilization (with or without gaseous plasma or vapor).

[0157] It should be understood that any example described herein may also include various other features besides or in lieu of those described above. By way of example only, any example described herein may also include one or more features disclosed in any of the various references incorporated herein by reference.

[0158] It should be understood that any one or more of the teachings, expressions, embodiments, examples, etc., described herein may be combined with any one or more of the other teachings, expressions, embodiments, examples, etc., described herein. Therefore, the aforementioned teachings, expressions, embodiments, examples, etc., should not be considered in isolation from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art upon reference to the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

[0159] It should be understood that any patent, patent publication, or other public material allegedly incorporated herein by reference, whether in whole or in part, is incorporated only to the extent that the incorporated material does not conflict with any existing definitions, statements, or other public material set forth in this disclosure. Therefore, and to the extent necessary, the disclosures expressly listed herein replace any conflicting material incorporated herein by reference. Any material, or part thereof, allegedly incorporated herein by reference that conflicts with any existing definitions, statements, or other public material set forth herein will be incorporated only to the extent that the incorporated material does not conflict with any existing public material.

[0160] While various embodiments of the invention have been shown and described, further improvements to the methods and systems described herein can be achieved by suitable modifications made by those skilled in the art without departing from the scope of the invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the examples, types, geometries, materials, dimensions, ratios, steps, etc., discussed above are exemplary and not essential. Therefore, the scope of the invention should be considered in accordance with the following claims and should be understood as not being limited to the details of the structures and operations shown and described in the specification and drawings.

Claims

1. A medical device comprising: (a) A catheter shaft assembly having a distal end; as well as (b) An end effector, positioned at the distal end of the catheter shaft assembly, the end effector comprising: (i) A balloon having a proximal end and a distal end, the balloon defining an interior configured to receive fluid to inflate the balloon, the balloon being sized and configured to fit within a cardiovascular anatomy. (ii) One or more electrodes located on the balloon. (iii) A tip assembly located at the distal end of the balloon, the tip assembly including a pressure relief valve configured to switch between a sealed state and a pressure-releasing state. (iv) A cylindrical member located at the distal end of the balloon, the tip assembly coupled to the cylindrical member, the tip assembly including a first cylindrical body disposed within the cylindrical member, the first cylindrical body including at least one lateral opening configured to provide a path for fluid leakage from the interior of the balloon, and (v) A resilient member operable to selectively seal the at least one lateral opening, such that the resilient member and the at least one lateral opening cooperate to form the pressure relief valve. The pressure relief valve, in its sealed state, is configured to prevent fluid from leaking out of the interior of the balloon via the pressure relief valve. The pressure relief valve, in the pressure relief state, is configured to provide a path for fluid to leak from the interior of the balloon via the pressure relief valve.

2. The device according to claim 1, wherein the elastic member is configured to elastically bias the pressure relief valve to the sealing state.

3. The device of claim 2, wherein the elastic member is configured to deform in response to the fluid pressure inside the balloon exceeding a pressure threshold, and the elastic member is operable to cause the pressure relief valve to transition from the sealed state to the pressure-relieving state by the deformation of the elastic member.

4. A medical device comprising: (a) A catheter shaft assembly having a distal end; as well as (b) An end effector, positioned at the distal end of the catheter shaft assembly, the end effector comprising: (i) A balloon having a proximal end and a distal end, the balloon defining an interior configured to receive fluid to inflate the balloon, the balloon being sized and configured to fit within a cardiovascular anatomy. (ii) One or more electrodes located on the balloon. (iii) A tip assembly located at the distal end of the balloon, the tip assembly including a pressure relief valve configured to switch between a sealed state and a pressure-releasing state, and (iv) A cylindrical member located at the distal end of the balloon, the tip assembly being coupled to the cylindrical member, the tip assembly including a first cylindrical body and a second cylindrical body, the first cylindrical body being disposed within the cylindrical member, the second cylindrical body being slidably disposed within the first cylindrical body, the first cylindrical body and the second cylindrical body being configured to define a leakage path between an inner diameter region of the first cylindrical body and an outer diameter of the second cylindrical body. The pressure relief valve, in its sealed state, is configured to prevent fluid from leaking out of the interior of the balloon via the pressure relief valve. The pressure relief valve, in the pressure relief state, is configured to provide a path for fluid to leak from the interior of the balloon via the pressure relief valve.

5. The device of claim 4, wherein the inner diameter region of the first cylindrical body defines a plurality of recessed grooves, the recessed grooves being configured to provide the leakage path.

6. The device of claim 4, wherein the first cylindrical body is operable to translate relative to the second cylindrical body, thereby changing the pressure relief valve from the sealed state to the pressure relief state.

7. The device according to claim 1 or 4, wherein the tip assembly further comprises a first flange positioned distal to the cylindrical member.

8. The device of claim 7, wherein the tip assembly further comprises a second flange positioned proximal to the cylindrical member.

9. The device according to claim 1 or 4, wherein the one or more electrodes comprise at least one electrode configured to sense potential in tissue.

10. The device according to claim 1 or 4, wherein the one or more electrodes comprise at least one electrode configured to ablate tissue.

11. The device of claim 1 or 4, wherein the balloon further comprises a plurality of openings configured to allow fluid to leak from the interior of the balloon while still allowing the balloon to inflate.

12. The device of claim 1 or 4, wherein the catheter shaft assembly includes an inner shaft extending through the interior of the balloon, the inner shaft being secured to the tip assembly.

13. The device of claim 12, wherein the inner shaft defines a lumen, the tip assembly defines a distal opening, the lumen and the distal opening are configured to accommodate an instrument passing through the inner shaft and through the tip assembly, the lumen and the distal opening being fluidly isolated relative to the internal fluid of the balloon.

Images