Systems, devices, and methods for forming an anastomosis

Abstract

Disclosed herein are systems, devices, and methods for treating heart failure. In some variations, a catheter for forming an anastomosis in a heart can include a first catheter including an electrode. A second catheter can be slidably disposed within the first catheter. The second catheter can include a barb and a dilator including a mating surface configured to engage the electrode.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefits of U.S. Provisional Application No. 62 / 971,357, filed February 7, 2020, and U.S. Provisional Application No. 62 / 900,034, filed September 13, 2019, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] The devices, systems, and methods described herein relate to forming anastomoses, including but not limited to anastomoses in a patient's heart. Background Technology

[0004] Congestive heart failure (CHF) is characterized by a decline in myocardial function, either due to a weakened pumping capacity or muscle stiffening caused by a reduced ability to fill with blood before ejection. With impaired blood flow from the heart to vital organs, the renin-angiotensin-aldosterone system (RAAS) is activated, signaling the body to retain fluid and thus increasing pressure in the ventricles. In particular, when left atrial pressure (LAP) rises, fluid flows back into the pulmonary circulation and can lead to pulmonary edema and severe dyspnea. Therefore, additional devices, systems, and methods for treating heart failure may be desired. Summary of the Invention

[0005] This document describes devices, systems, and methods for treating heart failure. These devices and systems can form anastomoses within anatomical structures. In some variations, the catheter for forming anastomoses in the heart may include a first catheter comprising an electrode. A second catheter may be slidably disposed within the first catheter. The second catheter may include barbs and a dilator, the dilator including mating surfaces configured to engage the electrode.

[0006] In some variations, the barbs may be disposed within the lumen of the electrode when the mating surface engages the electrode. In some variations, the outer diameter of the expander may be smaller than the outer diameter of the electrode. In some variations, the barbs may be configured to engage tissue.

[0007] In some variations, the second catheter may define a longitudinal axis. The barb may include at least one protrusion comprising a first portion and a second portion. The first portion may be angled relative to the second portion. The ratio of the length of the first portion to the length of the second portion may be between about 2:3 and about 1:5. In some variations, the second portion may include a length between about 0.1 mm and about 2 cm. The first portion may be at an angle of about 60 degrees to about 120 degrees relative to the longitudinal axis. In some variations, the first portion may be substantially perpendicular to the longitudinal axis. In some variations, the second portion may be at an angle of up to about 30 degrees relative to the longitudinal axis. In some variations, the second portion may be substantially parallel to the longitudinal axis. In some variations, the barb may include about 3 to about 7 protrusions. In some variations, at least one protrusion may include one of an "L" shape, a "J" shape, and a "C" shape. In some variations, at least one protrusion may include a plurality of protrusions configured as a set of concentric rings. In some variations, at least one protrusion may be configured to penetrate tissue.

[0008] In some variations, the barbs may include one or more protrusions at an angle of about 5 degrees to about 60 degrees relative to the longitudinal axis. In some of these variations, the one or more protrusions may be arranged in a row along the length of the barbs. In some variations, the protrusions may be configured to penetrate tissue and reduce tissue shear. In some variations, the length of the barbs may be between about 0.1 mm and about 5 cm. In some variations, the electrode and the mating surface may be configured to compress the tissue therebetween. In some variations, the second catheter may define a longitudinal axis, and the mating surface may be neither perpendicular nor parallel to the longitudinal axis.

[0009] In some variations, the first conduit may include an insulator disposed above a portion of the electrode. In some variations, the insulator may include a fluoropolymer material. In some variations, at least a portion of the distal surface of the electrode and the inner diameter of the electrode may not be insulated. In some variations, the electrode may be located close to the dilator. In some variations, the first conduit may define a ventilation lumen. In some variations, a signal generator may be configured to generate a biphasic waveform, and the signal generator may be coupled to the electrode.

[0010] In some variations, the barb may define a longitudinal axis, and the barb may be configured to rotate about the longitudinal axis. In some variations, the barb may be configured to rotate about 360 degrees about the longitudinal axis.

[0011] In some variations, the expander may define a groove configured to hold the barb. In some variations, in a first configuration, the barb may be disposed within the groove, and in a second configuration, at least a portion of the barb may be disposed outside the groove. In some variations, the length of the groove may be at least equal to the length of the barb. In some variations, the barb may be configured to translate relative to the expander to switch between the first and second configurations.

[0012] In some variations, the dilator may include a fluid port configured to dispense contrast agent. In some variations, the proximal portion of the dilator may include a fluid port. In some variations, the fluid port may be configured to receive the contrast agent from the lumen of the electrode. In some variations, the first catheter may include a contrast agent lumen. In some variations, the first catheter may be configured to dispense contrast agent. In some variations, the contrast agent may be dispensed into the lumen of the electrode. In some variations, the electrode may include a fluid port configured to dispense contrast agent. In some variations, the distal end of the electrode may include the fluid port.

[0013] In some variations, the expander may include an echo region. In some variations, the echo region may include one or more grooves or protrusions. In some variations, the one or more grooves or protrusions may include diameters between about 5 μm and about 100 μm. In some variations, the echo region may include a groove and protrusion density between about 5% and about 50%. In some variations, the expander may include one or more microspheres. In some variations, the one or more microspheres may include a gas core. In some variations, the one or more microspheres may include glass. In some variations, the echo region may be located on the surface of the expander. In some variations, the echo region may be located below the surface of the expander.

[0014] In some variations, a first catheter actuator may be configured to deflect a distal portion of the first catheter, the first catheter actuator being electrically coupled to the electrode. In some variations, a proximal end of the first catheter actuator may be configured to couple to an actuation mechanism. In some variations, the first catheter actuator may include a traction wire extending along the length of the first catheter. In some variations, the distal portion of the first catheter may include a predetermined bend. In some variations, the predetermined bend may include an angle between approximately 30 degrees and approximately 70 degrees.

[0015] In some variations, the mating surface may define a groove configured to receive the distal end of the electrode. In some variations, the electrode may be configured to short-circuit when the electrode engages the groove of the mating surface. In some variations, the mating surface may include a deformable material. In some variations, the mating surface may include a non-conductive portion. In some variations, the non-conductive portion may include one or more of polymers, ceramics, and alumina. In some variations, the mating surface may include a conductive portion.

[0016] In some variations, when the mating surface engages the electrode, the proximal portion of the expander may be disposed within the lumen of the electrode. In some variations, when the mating surface engages the electrode, approximately 0.5 mm to approximately 2 mm of the proximal portion of the expander may be disposed within the lumen of the electrode.

[0017] In some variations, the signal generator can be configured to generate a first waveform, followed by a second waveform. The signal generator can be coupled to the electrodes. The first waveform may include a first voltage, and the second waveform may include a second voltage. The first voltage may be higher than the second voltage.

[0018] Methods are also described herein. In some variations, the method of forming an anastomosis in the heart may include advancing a first catheter and a second catheter into the right atrium. The first catheter may include a tubular electrode defining a lumen, and the second catheter may include a dilator and barbs. The second catheter may be advanced into the left atrium through the interatrial septum such that the first catheter is located in the right atrium. The second catheter may be withdrawn relative to the first catheter to engage a first portion of the septum with the barbs, withdraw the first portion back into the lumen, and compress a second portion of the septum located between the electrode and the dilator. An ablation waveform may be delivered to the electrode to cut the second portion such that the first portion remains within the lumen.

[0019] In some variations, withdrawing the second conduit toward the first conduit may include retracting the barbs back into the lumen. In some of these variations, the size of the first portion cut from the second portion may correspond to the distance the barbs are retracted into the lumen. In some variations, withdrawing the second conduit toward the first conduit may stretch the first portion. In some variations, the first portion may be formed into a generally conical or cylindrical shape when engaged by the barbs.

[0020] In some variations, the first portion of the diaphragm may form a generally cylindrical shape when withdrawn into the lumen. In some variations, the first portion of the diaphragm engaging the barbs may be intact when withdrawn into the lumen. In some variations, the barbs may pierce the first portion when the second catheter is withdrawn toward the first catheter. In some variations, an anastomosis with a diameter between approximately 1 mm and approximately 1.5 cm may be formed in response to delivery of the ablation waveform. In some variations, the first portion may form a generally conical shape when engaged by the barbs. In some variations, the first portion may be engaged by the barbs at least during delivery of the ablation waveform. In some variations, the first portion may be engaged by the barbs after the ablation waveform has been delivered to the electrode.

[0021] In some variations, the second portion can be compressed with a force of at least 20 grams. In some variations, during the engagement, at least a portion of the barb can penetrate the diaphragm. In some variations, the electrodes can be electrically short-circuited when they contact the dilator during the delivery of the ablation waveform. In some variations, the ablation waveform may include a biphasic waveform. In some variations, fluorescence imaging of one or more radiopaque portions of the first and second catheters can be performed in one or more steps.

[0022] In some variations, engaging the first portion of the diaphragm to the barb may include rotating the barb about its longitudinal axis. In some variations, the size of the first portion cut from the second portion may correspond to the rotation angle of the barb. In some variations, rotating the barb may include a rotation angle of up to about 360 degrees.

[0023] In some variations, withdrawing the second catheter toward the first catheter may include translating the barbs relative to the dilator to engage the first portion of the diaphragm.

[0024] In some variations, withdrawing the second catheter toward the first catheter may include removing the barbs from the dilator.

[0025] In some variations, withdrawing the second catheter toward the first catheter may include switching from a first configuration in which the barbs are arranged within the groove of the expander to a second configuration in which the barbs are arranged outside the groove.

[0026] In some variations, contrast agents can be introduced into the heart via a fluid port in the dilator. In some variations, contrast agents can be introduced into the lumen of the electrode. In some variations, ultrasound can be received from the distal end of the ablation device. In some variations, the distal end of the ablation device may include one or more microspheres having a diameter between about 5 μm and about 100 μm.

[0027] In some variations, withdrawing the second catheter toward the first catheter can deform the proximal portion of the dilator. In some variations, withdrawing the second catheter toward the first catheter may include engaging a mating surface of the electrode to the second catheter. In some variations, compressing the second portion of the diaphragm may include the distal end of the electrode and the mating surface of the dilator. In some variations, the second portion may be compressed with a force of up to about 25 N.

[0028] In some variations, the ablation waveform may include a first waveform followed by a second waveform. The first waveform may include a first voltage, and the second waveform may include a second voltage. The first voltage may be higher than the second voltage.

[0029] In some variations, the proximal portion of the expander may include a first stepped portion including a first diameter and a second stepped portion including a second diameter larger than the first diameter. The first stepped portion may be adjacent to the second stepped portion. In some variations, the second step may include the mating surface configured to engage the distal end of the electrode. In some variations, the mating surface may be substantially perpendicular to the longitudinal axis of the expander. In some variations, the first step may be configured to engage the sidewall of the electrode when the expander engages the electrode. In some variations, the expander may be configured to attach to the first conduit when the expander engages the electrode.

[0030] In some variations, the system for creating an anastomosis in the heart may include: a first catheter including electrodes; and a second catheter slidably disposed within the first catheter. The second catheter may include barbs and a dilator. The proximal portion of the dilator may include a first stepped portion including a first diameter and a second stepped portion including a second diameter larger than the first diameter. The first stepped portion may be adjacent to the second stepped portion.

[0031] In some variations, the system for creating an anastomosis in the heart may include: a first catheter including an electrode; and a second catheter slidably disposed within the first catheter. The second catheter may include barbs and a dilator. When the dilator engages the electrode, the barbs may be closed within the lumen of the electrode.

[0032] In some variations, the system for creating an anastomosis in the heart may include: a first catheter including an electrode; and a second catheter slidably disposed within the first catheter. The second catheter may include barbs and a dilator. The system may be configured to compress the tissue between the electrode and the dilator with a first predetermined force.

[0033] In some variations, the expander may be configured to shear tissue with a second predetermined force greater than the first predetermined force. In some variations, the first predetermined force may be as high as about 25 N. In some variations, the second predetermined force may be greater than about 25 N. Attached Figure Description

[0034] Figure 1 Provides cross-sectional views of the heart showing various anatomical structures.

[0035] Figures 2A to 2F This is a schematic perspective view of an exemplary variation of a method for forming anastomosis using an ablation system.

[0036] Figure 3 It is a schematic block diagram of an exemplary variant of the ablation system.

[0037] Figure 4 This is a perspective view of an exemplary variation of the ablation device.

[0038] Figure 5A This is a schematic cross-sectional side view of an exemplary variant of the ablation device in an open configuration. Figure 5B This is a schematic cross-sectional side view of an exemplary variant of an ablation device in a closed configuration.

[0039] Figure 6A This is a schematic side view of an exemplary variant of an ablation device in a closed configuration. Figure 6B yes Figure 6A A schematic cross-sectional side view of the ablation device shown. Figure 6C yes Figure 6B A detailed cross-sectional side view of the ablation device shown.

[0040] Figure 7A This is a schematic side view of an exemplary variant of the ablation device in an open configuration. Figure 7B yes Figure 7A A schematic cross-sectional side view of the ablation device shown. Figure 7C yes Figure 7B A detailed cross-sectional side view of the ablation device shown.

[0041] Figure 8 It is a schematic perspective view of an exemplary variation of the ablation device.

[0042] Figure 9A This is a schematic side view of an exemplary variant of an ablation device in a closed configuration. Figure 9B This is a schematic cross-sectional side view of an exemplary variant of an ablation device in a closed configuration.

[0043] Figure 10A This is a schematic side view of an exemplary variant of the ablation device in an open configuration. Figure 10B This is a schematic cross-sectional side view of an exemplary variant of the ablation device in an open configuration.

[0044] Figure 11A This is a schematic cross-sectional side view of an exemplary variation of the electrode of the ablation device. Figure 11B yes Figure 11A A detailed cross-sectional side view of the distal end of the electrode shown.

[0045] Figure 12A This is a schematic perspective view of an exemplary variation of the connector of the ablation device. Figure 12B This is a schematic front view of an exemplary variation of the connector of the ablation device. Figure 12C This is a schematic cross-sectional side view of an exemplary variation of the connector of the ablation device.

[0046] Figure 13A This is a schematic perspective view of an exemplary variation of the barbs of the ablation device. Figure 13B This is a schematic side view of an exemplary variation of the barbs of the ablation device. Figure 13C This is a schematic front view of an exemplary variation of the barb of the ablation device.

[0047] Figure 14 This is a schematic side view of an exemplary variation of the barbs of the ablation device.

[0048] Figure 15A This is a schematic perspective view of an exemplary variation of the barbs of the ablation device. Figure 15B This is a schematic front view of an exemplary variation of the barb of the ablation device.

[0049] Figure 16 This is a schematic side view of an exemplary variation of the barbs of the ablation device.

[0050] Figure 17A and 17B These are schematic side and perspective views of an exemplary variant of the barbs of the ablation device.

[0051] Figure 18 This is a flowchart illustrating an exemplary variation of the method for forming a match.

[0052] Figure 19A and 19B It is a schematic perspective view of an exemplary variant of an ablation device in the endocardial space. Figures 19C to 19F This is a schematic cross-sectional side view of an exemplary variant of an ablation device in the endocardial space.

[0053] Figure 20 This is a perspective view of an exemplary variation of the ablation device.

[0054] Figure 21 This is a perspective view of an exemplary variation of the ablation device.

[0055] Figure 22 This is a perspective view of an exemplary variant of an ablation device used to cut tissue.

[0056] Figure 23 It is a fluorescence microscopy visualization of an exemplary variant of an ablation device in both open and closed configurations.

[0057] Figure 24 These are images of matching structures formed within cadaveric tissue.

[0058] Figure 25A and 25B This is an image of anastomosis formed in pig tissue.

[0059] Figure 26A This is a schematic side view of an exemplary variation of the barbs of the ablation device. Figure 26B This is a schematic perspective view of an exemplary variation of the barbs of the ablation device. Figure 26C This is a schematic front view of an exemplary variation of the barb of the ablation device.

[0060] Figure 27A and 27B This is a perspective view of an exemplary variant of an ablation device used to cut tissue. Figure 27C It is an image of a match formed in the tissue.

[0061] Figure 28A and 28B This is a perspective view of an exemplary variant of an ablation device used to cut tissue.

[0062] Figure 29A , 29B 29C is a side view of the barbs of the ablation device in the endocardial space.

[0063] Figure 30A and 30B This is a cross-sectional side view of the barbs and catheter of the ablation device.

[0064] Figure 31A This is a side view of an exemplary variant of the ablation device. Figure 31B This is a cross-sectional side view of an exemplary variant of the ablation device. Figure 31C yes Figure 31B A detailed cross-sectional side view of the ablation device shown. Figure 31D , 31E 31F is a perspective view of an illustrative variant of the distal portion of the ablation device.

[0065] Figure 32 This is a side view of an exemplary variant of an ablation device in the endocardial space.

[0066] Figure 33A This is a side view of an exemplary variant of the catheter of the ablation device. Figure 33B This is a cross-sectional side view of an exemplary variant of the catheter of the ablation device.

[0067] Figure 34A and 34B This is a cross-sectional plan view of the distal end of the catheter of the ablation device. Figure 34C and 34D This is a cross-sectional side view of the catheter of the ablation device.

[0068] Figure 35A This is a cross-sectional side view of an exemplary variant of the distal portion of the ablation device. Figure 35B This is a detailed cross-sectional side view of another variation of the distal portion of the ablation device.

[0069] Figure 36A and 36B This is a side view of an exemplary variant of an ablation device in the endocardial space.

[0070] Figure 37 It is an exemplary variation of the voltage waveform during ablation surgery.

[0071] Figure 38A and 38B This is a cross-sectional side view of an exemplary variant of an ablation device in an open and closed configuration.

[0072] Figure 39A This is a perspective view of an illustrative variation of the handle of the ablation device. Figure 39B yes Figure 39A The diagram shows a plan view of the handle.

[0073] Figure 40A This is a side view of an illustrative variation of the barbs of the ablation device. Figure 40B This is a perspective view of an illustrative variation of the barbs of the ablation device.

[0074] Figure 41A and 41B These are schematic side and perspective views of an exemplary variant of the barbs of the ablation device.

[0075] Figure 42A and 42B These are schematic side and perspective views of exemplary variations of the electrodes of the ablation device. Detailed Implementation

[0076] This document describes devices, systems, and methods for treating heart failure (e.g., congestive heart failure) by lowering blood pressure in the left atrium of a patient. For example, an anastomosis between the right and left atria can be formed using an energy-based tissue ablation system to alleviate elevated left atrial blood pressure. Generally, the systems described herein can, for example, have portions of the device positioned on opposite sides of the interatrial septum. A portion of the septum can be engaged to the device using barbs. In some variations, a portion of the barbs can penetrate the septum, allowing the barbs to securely hold an intact portion of the septum tissue. The engaged tissue can be stretched, secured, and withdrawn into the lumen of the device. In some variations, the size (e.g., diameter) of the tissue to be cut can be controlled by varying the distance the engaged tissue is withdrawn into the lumen. Another portion of the septum can be compressed between the proximal end of an electrode and a dilator to secure an additional portion of the septum to the device. The electrodes can use radiofrequency (RF) energy to ablate the tissue to form an anastomosis in the interatrial septum. Following ablation, the electrodes can contact the dilator, allowing the tissue portion engaged, held, and / or fixed by barbs to remain enclosed within the lumen of the device for removal from the patient. One or more visualization techniques and features incorporated into the ablation device can be used to visualize one or more steps of the treatment procedure. Therefore, the first and second catheters described herein can improve the efficiency and safety of anastomosis procedures and allow for a reduction in catheter size.

[0077] In cases where the heart is a relevant anatomical structure, it may be helpful to briefly identify and describe the relevant cardiac anatomy. Figure 1 This is a cross-sectional view of the heart (100). The left atrium (110), right atrium (120), and interatrial septum (130) are shown. Figure 1 An opening (132) (e.g., an aperture) is shown formed between the left atrium (110) and the right atrium (120). For example, the opening (132) can be formed during anastomosis surgery using the systems, devices, and methods described herein. The opening (132) may have predetermined characteristics configured to treat heart failure.

[0078] The method is also described here. In some variations, the method for forming anastomoses in the atrial septum may include... Figure 2A The steps shown include advancing the ablation device (200) into the patient's right atrium (230). The distal end of the device (200) may include a dilator of a second catheter (250) configured to puncture the interatrial septum (210) and advance into the patient's left atrium (220). In some variations, a guidewire (not shown) of the device (200) may be advanced through the interatrial septum (210) and into the left atrium (220). Figure 2BAs shown, the dilator can puncture the diaphragm (210) so that a portion of the second catheter (250) is positioned in the left atrium (220) and the first catheter (240) is positioned in the right atrium (230).

[0079] Figure 2C A second catheter (250) is shown advanced relative to the first catheter (240), such that barbs (260) of the second catheter (250) are advanced through the septum (210) and into the left atrium (220). The barbs (260) can be configured to engage a portion of the septum (210) for ablation. For example, the engaged portion of the septum can be held and / or secured between protrusions of the barbs (260). By positioning the device (200) on both sides of the interatrial septum (210), a predetermined force can be applied from the respective catheters (240, 250) to engage and cut predetermined portions of the septal tissue.

[0080] like Figure 2D As shown, the second conduit (250) can be retracted relative to the first conduit (240) so that a portion (212) of the diaphragm (210) can engage the barb (260) and extend. Electrode (242) Figure 2A Each of the barb (260) and the barb (242) can be positioned to engage opposite sides of the septal tissue (212). For example, withdrawing the barb (260) into the lumen of the electrode (242) can engage and stretch the tissue (212) to form a tent-like shape, which can facilitate the formation of anastomosis. Figure 2D The tissue (212) is shown open toward the right atrium (230). In this way, the tissue (212) to be cut is secured within the device (200) before resection to reduce the risk of uncontrolled tissue loss in the ventricles and vascular system.

[0081] In some of these variations, the electrode (250) may include a tubular shape configured to cut tissue using RF energy and facilitate tissue capture. In some variations, the mating surface of the expander (250) may be configured to engage, hold, and fix the cut tissue against the cutting surface of the electrode (242). An ablation waveform may be delivered to the electrode (242) to cut a portion (212) of the compartment (210) stretched by the device (200). For example, the ablation waveform may include RF energy as described in more detail herein. When the electrode (242) is energized, the second conduit (250) may be positioned against the first conduit (240) such that the barb (260) is held within the lumen of the electrode (242).

[0082] Once the diaphragm (210) is cut, as Figure 2EAs shown, a hole (214) can be formed in the diaphragm (210). The second catheter (250) can be withdrawn from the left atrium (220), and the device (210) can be removed from the patient, as shown. Figure 2F As shown in the diagram. Therefore, the ablation device (200) can form an atrial anastomosis. The ablation device described herein can improve the efficiency and safety of anastomosis procedures and allows for a reduction in device size. For example, after passing through the atrial septum (210), the operator can capture and fix tissue by advancing and withdrawing a second catheter (250) relative to the first catheter (240) without additional actuation mechanisms. This and other benefits of the device and method will be described in more detail below.

[0083] I. System

[0084] Overview

[0085] The system described herein may include one or more components for ablating tissue using the apparatus described herein. Figure 3 This is a block diagram of a variant of an ablation system (300) including an ablation device (310), a handle (320), and a signal generator (330). In some variants, the ablation device (310) may be designed to be disposable after each use, while in other variants, one or more parts of the ablation device (310) may be designed to be reusable (e.g., for multiple uses and for one or more patients), such as the handle (320) and the signal generator (330).

[0086] In some variations, the ablation device (310) may include a first catheter and a second catheter, the first and second catheters being sized and shaped to be placed in a patient's body cavity (e.g., a heart chamber). In some variations, the ablation device (310) may include one or more of a guidewire (312), a dilator (314), a barb (316), and an electrode (318). The distal end of the ablation device (310) may include the dilator (314), and the guidewire (312) may extend from the lumen of the dilator (314). In some variations, the electrode (318) may be positioned close to the barb (316), while in other variations, the electrode (318) may be positioned away from the barb (316). Additionally or alternatively, the ablation system (300) may include a delivery catheter configured to advance over the ablation device (310). In addition, the ablation device (310) may include one or more sensors configured to measure one or more predetermined characteristics, such as temperature, pressure, impedance, etc.

[0087] In some variations, the proximal end of the ablation device (310) may be coupled to a handle (320). The handle (320) may include actuators (322) configured to control one or more of the movement, positioning, configuration, orientation, operation, and energy delivery of the ablation device (310). For example, the actuators (322) may be operated to manipulate and / or translate one or more portions of the ablation device (310). In some variations, a signal generator (330) may be coupled to one or more of the ablation device (310) and the handle (320). The signal generator (330) may be configured to generate one or more ablation waveforms for delivery to the electrodes (318) of the ablation device (310). The signal generator (330) may include a controller (332) configured to control the signal generator (330) and provide appropriate energy waveforms for tissue ablation while ensuring patient safety.

[0088] Figure 4 This is a perspective view of a variant of the ablation device (400). In some variants, the ablation device (400) may include a first catheter (410) and a second catheter (430). The first catheter (410) may include a tubular electrode (420). The electrode (420) may define a lumen (422) configured to hold one or more portions of the second catheter (430). Figure 4 The electrode (420) shown has a cylindrical shape. However, the electrode (420) can include any desired cross-sectional shape (e.g., elliptical, square, rectangular, triangular). Figure 4 The electrode (420) shown may include a distal cut edge. However, the electrode (420) may have chamfered or non-planar edges (e.g., wavy, crenellated, serrated, sinusoidal, periodic, etc.).

[0089] In some variations, the ablation device (400) may include a second catheter (430) slidably disposed within a first catheter (410). The second catheter (430) may include barbs (440) and a dilator (450) configured to engage an electrode (420). In some variations, the barbs (440) may be coupled to a proximal portion of the dilator (450). Tissue-engaging portions (e.g., protrusions, tips) of the barbs (440) may generally face the electrode (420). The barbs (440) may include a plurality of protrusions. In some variations, one or more of the protrusions may be bent to form a curved shape. In some variations, the proximal portion of the dilator (450) may be configured to contact the electrode (420) when the second catheter (430) is withdrawn relative to the first catheter (410). The dilator (450) may have a generally conical shape, for example, tapering towards the distal end of the second catheter (430). However, the dilator (450) may include any predetermined size, pattern, and shape. For example, at least a portion of the dilator (450) may be configured to be recessed into the lumen (422) of the electrode (420) to secure the dilator (450) to the catheter (410) during catheter delivery and removal, and to further secure the excised tissue during withdrawal from the patient.

[0090] As described in more detail herein, the second catheter (430) may be configured to translate relative to the first catheter (410). For example, the second catheter (430) may translate along the longitudinal axis of the first catheter (410). In some variations, one or more of the second catheter (430), barb (440), and dilator (450) may translate into the lumen (422) of the electrode (420). As described in more detail herein, the electrode (420) may be configured to ablate compressed tissue between the distal end of the electrode (420) (e.g., distal cutting edge, bevel) and the dilator (450).

[0091] Figure 5AThis is a schematic cross-sectional side view of a variant of the ablation device (500) in an open configuration. In some variants, the ablation device (500) may include a first conduit (510) and a second conduit (530). The first conduit (510) may include a tubular electrode (520) and a connector (526) coupled to the electrode (520). The electrode (520) may define a lumen (522) configured to hold one or more portions of the second conduit (530). The first conduit (510) may further include a wire (524) coupled to the electrode (520) and a signal generator (not shown). In some variants, the first conduit (510) may include an insulator (560) configured to cover a portion of the electrode (520). For example, the insulator (560) may be configured to cover the outer surface of the electrode (520), wherein the distal end and inner surface of the electrode (520) are not insulated.

[0092] In some variations, the ablation device (500) may include a second conduit (530) slidably disposed within a first conduit (510). The second conduit (530) may include barbs (540) and a dilator (550) configured to engage an electrode (520). In some variations, the barbs (540) may include a plurality of protrusions arranged in a row, generally angled toward the electrode (520). For example, the protrusions may be arranged in a row along the length of the dilator (550). Additionally or alternatively, one or more of the protrusions may be bent to form a curved shape. The dilator (550) may be tapered and define a lumen (552). The electrode (520) may be located close to the dilator (550). In some variations, the dilator (550) may include a mating surface (554) configured to engage the electrode (520). For example, the electrode (520) and the mating surface (554) may be configured to compress tissue (not shown) between them. In some variations, the mating surface (554) may not be perpendicular to or parallel to the longitudinal axis of the second conduit (530) (e.g., beveled, chamfered). Figure 5A and 5B As shown, the distal end of the electrode (520) and the mating surface (554) can be radial.

[0093] Figure 5BThis is a schematic cross-sectional side view of a variant of the ablation device (500) in a closed configuration. In the closed configuration, the barb (540) can be surrounded by the electrode (520), the connector (526), ​​and the dilator (550). That is, the barb (540) can be positioned within the lumen (522) of the electrode (520) when the mating surface (554) engages the electrode (520). Therefore, any tissue engaged by the barb (540) can also be closed and secured within the ablation device (500) in the closed configuration by one or more of the barb (540) and the electrode (520). In some variants, the outer diameter of the dilator (550) can be smaller than the outer diameter of the distal end of the first conduit (510). For example, the outer diameter of the dilator (550) can be smaller than the outer diameter of the electrode (520). This allows control over the shape of the opened tissue engaged by the ablation device (500). As described in more detail in this article, the length and shape of the barbs (540) can further control the size and shape of the opened tissue.

[0094] Figure 6A This is a schematic side view of a variant of the ablation device (600) in a closed configuration. Figure 6A An ablation device (600) is shown, which includes a first catheter (610), an electrode (620), a dilator (650), and an insulator (660). Figure 6B This is a schematic cross-sectional side view of the ablation device (600). In some variations, the ablation device (600) may include a first conduit (610) and a second conduit (630). The first conduit (610) may include a tubular electrode (620) and a connector (626) coupled to the electrode (620). The electrode (620) may define a lumen (622) configured to hold one or more portions of the second conduit (630). The first conduit (610) may further include a wire (624) coupled to the electrode (620) and a signal generator (not shown). In some variations, the first conduit (610) may include an insulator (660) configured to cover a portion of the electrode (620). For example, the insulator (660) may be configured to cover the outer surface of the electrode (620), wherein the distal end and inner surface of the electrode (620) are not insulated.

[0095] In some variations, the ablation device (600) may include a second conduit (630) slidably disposed within a first conduit (610). The second conduit (630) may include barbs (640) and a dilator (650) configured to engage an electrode (620). In some variations, the barbs (640) may include a plurality of protrusions arranged in a row, generally angled toward the electrode (620). For example, the protrusions may be arranged in a row along the length of the dilator (650). Additionally or alternatively, one or more of the protrusions may be bent to form a curved shape. The dilator (650) may be tapered and define a lumen (652). The electrode (620) may be located close to the dilator (650). Additionally or alternatively, one or more of the protrusions may be bent to form a curved shape.

[0096] In the closed configuration, the barb (640) can be surrounded by the electrode (620), the connector (626), and the expander (650). That is, the barb (640) can be disposed within the lumen (622) of the electrode (620) when the mating surface (654) engages the electrode (620). Therefore, any tissue engaged by the barb (640) can also be closed, held, and / or fixed within the ablation device (600) in the closed configuration.

[0097] Figure 6C yes Figure 6B A detailed cross-sectional side view of the ablation device (600) shown. Specifically, the dilator (650) may include a mating surface (654) configured to engage the electrode (620). For example, the electrode (620) and the mating surface (654) may be configured to compress tissue (not shown) between them. In some variations, the mating surface (654) may not be perpendicular to or parallel to the longitudinal axis of the second conduit (630) (e.g., beveled, chamfered). The distal end of the electrode (620) and the mating surface (654) may be radial. Figure 6B and 6C As shown, the outer diameter of the expander (650) can be smaller than the outer diameter of the electrode (620).

[0098] Figure 7A This is a schematic side view of a variant of the ablation device (700) in the open configuration. Figure 7A An ablation device (700) is shown, which includes a first catheter (710), an electrode (720), a second catheter (730), a barb (740), a dilator (750), and an insulator (760). Figure 7B yes Figure 7AA schematic cross-sectional side view of the ablation device (700) shown. In some variations, the ablation device (700) may include a first conduit (710) and a second conduit (730). The first conduit (710) may include a tubular electrode (720) and a connector (726) coupled to the electrode (720). The electrode (720) may define a lumen (722) configured to hold one or more portions of the second conduit (730). The first conduit (710) may further include a wire (724) coupled to the electrode (720) and a signal generator (not shown). In some variations, the first conduit (710) may include an insulator (760) configured to cover a portion of the electrode (720). For example, the insulator (760) may be configured to cover the outer surface of the electrode (720), wherein the distal end and inner surface of the electrode (720) are not insulated.

[0099] In some variations, the ablation device (700) may include a second conduit (730) slidably disposed within a first conduit (710). The second conduit (730) may include barbs (740) and a dilator (750) configured to engage an electrode (720). In some variations, the barbs (740) may include a plurality of protrusions arranged in a row, generally angled toward the electrode (720). For example, the protrusions may be arranged in a row along the length of the dilator (750). Additionally or alternatively, one or more of the protrusions may be bent to form a curved shape. The dilator (750) may be tapered and define a lumen (752). The electrode (720) may be located close to the dilator (750).

[0100] Figure 7C yes Figure 7B A detailed cross-sectional side view of the ablation device (700) shown. Specifically, the dilator (750) may include a mating surface (754) configured to engage the electrode (720). For example, the electrode (720) and the mating surface (754) may be configured to compress tissue (not shown) between them. In some variations, the mating surface (754) may not be perpendicular to or parallel to the longitudinal axis of the second conduit (730) (e.g., beveled, chamfered). The distal end of the electrode (720) and the mating surface (754) may be radial.

[0101] Figures 8 to 10B A variation of the additional ablation device is shown. Figure 8 This is a perspective view of a variant of the ablation device (800). In some variants, the ablation device (800) may include a first catheter (810) and a second catheter (830). The first catheter (810) may include a tubular electrode (820). The electrode (820) may define a lumen (822) configured to hold one or more portions of the second catheter (830). Figure 8 The electrode (820) shown has a cylindrical shape. However, the electrode (820) can include any desired cross-sectional shape (e.g., elliptical, square, rectangular, triangular).

[0102] In some variations, the ablation device (800) may include a second conduit (830) slidably disposed within a first conduit (810). The second conduit (830) may include barbs (840) and a dilator (850) configured to engage an electrode (820). In some variations, the barbs (840) may be coupled to a proximal portion of the dilator (850). The barbs (840) may include a tapered portion and a plurality of protrusions arranged radially around the barbs (840) and staggered along the length of the second conduit (830). Tissue engaged by one or more of the protrusions may form a generally conical shape that generally follows the tapered shape of the barbs (840). The plurality of protrusions may have the same or different lengths, diameters, and tapers. Each row may have the same or different number of protrusions. The plurality of protrusions may have the same or different angles relative to the second conduit (830).

[0103] In some variations, multiple protrusions of the barb (840) (e.g., tissue-jointing portions) may be generally parallel to the longitudinal axis of the second catheter (830). In some variations, the proximal portion of the dilator (850) may be configured to contact the electrode (820) when the second catheter (830) is withdrawn relative to the first catheter (810). The dilator (850) may have a generally conical shape, for example, tapering towards the distal end of the second catheter (830). However, the dilator (850) may include any predetermined size, pattern, and shape.

[0104] As described in more detail herein, the second catheter (830) can be configured to translate relative to the first catheter (810). For example, the second catheter (830) can translate along the longitudinal axis of the first catheter (810). In some variations, one or more of the second catheter (830), barb (840), and dilator (850) can be translated into the lumen (822) of the electrode (820). As described in more detail herein, the electrode (820) can be configured to ablate compressed tissue between the distal end of the electrode (820) and the dilator (850).

[0105] Figure 9A This is a schematic side view of a variant of the ablation device (900) in a closed configuration. Figure 9A An ablation device (900) is shown, comprising a first catheter (910), an electrode (920), and a dilator (950). Figure 9BThis is a schematic cross-sectional side view of the ablation device (900). In some variations, the ablation device (900) may include a first conduit (910) and a second conduit (930). The first conduit (910) may include a tubular electrode (920) and a connector (926) coupled to the electrode (920). The electrode (920) may define a lumen (922) configured to hold one or more portions of the second conduit (930) (e.g., barbs (940)). The first conduit (910) may further include a wire (not shown) coupled to the electrode (920) and a signal generator (not shown). In some variations, the first conduit (910) may include an insulator (960) configured to cover a portion of the electrode (920). For example, the insulator (960) may be configured to cover the outer surface of the electrode (920) such that the distal end and inner surface of the electrode (920) are not insulated.

[0106] In some variations, the ablation device (900) may include a second conduit (930) slidably disposed within a first conduit (910). The second conduit (930) may include barbs (940) and a dilator (950) configured to engage an electrode (920). In some variations, the barbs (940) may include a plurality of protrusions arranged in a row generally parallel to the longitudinal axis of the second conduit (930). For example, the protrusions may be arranged in a row along the length of the second conduit (930). Additionally or alternatively, one or more of the protrusions may be bent to form a curved shape. The dilator (950) may be tapered and define a lumen (952). In some variations, the dilator (950) may include a mating surface (954) configured to engage an electrode (920). For example, the electrode (920) and the mating surface (954) may be configured to compress tissue (not shown) between them. Figure 9B In this configuration, the mating surface (954) is approximately perpendicular to the longitudinal axis of the second conduit (930). The electrode (920) may be located close to the expander (950). The distal end of the electrode (920) and the mating surface (954) may be radial.

[0107] In the closed configuration, the barb (940) can be surrounded by the electrode (920), the connector (926), and the expander (950). That is, the barb (940) can be disposed within the lumen (922) of the electrode (920) when the mating surface (954) of the expander (950) engages the electrode (920). Therefore, any tissue engaged by the barb (940) can also be closed, held, and / or fixed within the ablation device (900) in the closed configuration.

[0108] Figure 10A This is a schematic side view of a variant of the ablation device (1000) in the open configuration. Figure 10A An ablation device (1000) is shown, which includes a first catheter (1010), an electrode (1020), a second catheter (1030), a barb (1040), and a dilator (1050). Figure 10B yes Figure 10A The diagram shows a schematic cross-sectional side view of the ablation device (1000). In some variations, the ablation device (1000) may include a first conduit (1010) and a second conduit (1030). The first conduit (1010) may include a tubular electrode (1020) and a connector (1026) coupled to the electrode (1020). The electrode (1020) may define a lumen (1022) configured to hold one or more portions of the second conduit (1030). The first conduit (1010) may further include a wire (not shown) coupled to the electrode (1020) and a signal generator (not shown). In some variations, the first conduit (1010) may include an insulator (1060) configured to cover a portion of the electrode (1020). For example, the insulator (1060) may be configured to cover the outer surface of the electrode (1020) such that the distal end and inner surface of the electrode (1020) are not insulated.

[0109] In some variations, the ablation device (1000) may include a second conduit (1030) slidably disposed within a first conduit (1010). In some variations, the barb (1040) may include a plurality of protrusions arranged in a row generally parallel to the longitudinal axis of the second conduit (1030). For example, the protrusions may be arranged in a row along the length of the second conduit (1030). Additionally or alternatively, one or more of the protrusions may be bent to form a curved shape. The dilator (1050) may be tapered and define a lumen (1052). In some variations, the dilator (1050) may include a mating surface (1054) configured to engage an electrode (1020). For example, the electrode (1020) and the mating surface (1054) may be configured to compress tissue (not shown) between them. Figure 10B In this configuration, the mating surface (1054) is approximately perpendicular to the longitudinal axis of the second conduit (1030). The electrode (1020) may be located close to the expander (1050). The distal end of the electrode (1020) and the mating surface (1054) may be radial.

[0110] Figure 38AThis is a schematic cross-sectional side view of a variant of the ablation device (3800) in a closed configuration. In some variants, the ablation device (3800) may include a first conduit (3810) and a second conduit (3830). The first conduit (3810) may include an electrode (3820), such as a tubular electrode. The electrode (3820) may define a lumen configured to hold one or more portions of the second conduit (3830). The first conduit (3810) may also include a first conduit actuator (3822) (e.g., a wire, an electrical traction wire) coupled to the electrode (3820) and a signal generator (not shown). As described in more detail herein, the first conduit actuator (3822) may be configured to deliver electrical energy to the electrode (3820) and to deflect a distal portion of the ablation device (3800) in a traction wire manner. In some variations, the first catheter (3810) may include an insulator (3824) configured to cover a portion of the electrode (3820). For example, the insulator (3824) may be configured to cover the outer surface of the electrode (3820), wherein the distal end and inner surface of the electrode (3820) are not insulated. In some variations, the first catheter (3810) may include a contrast agent lumen (3812), as described in more detail herein.

[0111] In some variations, the ablation device (3800) may include a second conduit (3830) slidably disposed within a first conduit (3810). The second conduit (3830) may include barbs (3840) and a dilator (3850) configured to engage an electrode (3820). In some variations, the barbs (3840) may include a plurality of radially arranged protrusions (3842, 3844) that generally extend toward the electrode (3820). For example, the protrusions (3842, 3844) may include a distal portion (3842) configured to puncture tissue and a proximal portion (3844) configured to stop the tissue.

[0112] In some variations, the dilator (3850) may be tapered and define a lumen (3852). In some variations, a guidewire (not shown) may be slidably disposed within the lumen (3852). In some variations, the dilator (3850) may include a proximal portion (3854) and an echo region (not shown). For example, the echo region may include a predetermined surface texture configured for visualization using ultrasound imaging. The proximal portion (3854) of the dilator (3850) may be configured to engage an electrode (3820) in a closed configuration. That is, in a closed configuration of the ablation device (3800), the proximal portion (3854) may be configured to be located within the lumen of the electrode (3820). In some variations, the dilator (3850) may include a mating surface (3856) configured to engage the electrode (3820). For example, the electrode (3820) and the mating surface (3856) can be configured to compress the tissue between them (not shown), as per [reference to...]. Figure 36A For more detailed discussion. The mating surface (3856) of the expander (3850) may extend radially and / or longitudinally.

[0113] In the closed configuration, the barb (3840) can be surrounded by the first conduit (3810), the electrode (3820), and the dilator (3850). That is, the barb (3840) can be disposed within the lumen of the electrode (3820) when the proximal portion (3854) (e.g., mating surface (3856)) engages the electrode (3820) (e.g., is disposed therein). Therefore, any tissue engaged by the barb (3840) can also be closed and secured within the ablation device (3800) in the closed configuration by means of one or more of the barb (3840) and the electrode (3820). The proximal portion (3854) disposed within the lumen of the electrode (3820) can securely and coaxially attach the electrode (3820) to the dilator (3850). For example, the dilator (3850) can be secured to the first catheter (3810) to resist movement from lateral loads, such as when the ablation device (3800) is being tracked over a curved guidewire. Furthermore, the electrode (3820) securely coupled to the dilator (3850) can be configured to prevent the ablation device (3800) from hooking (e.g., gripping) blood vessels, tissues (e.g., via septal crossing), guides, sheaths, etc., during advancement and withdrawal through body cavities. In some variations, when mated with a surface-attached electrode (3820), a proximal portion (3854) of the dilator (3850) of approximately 0.5 mm to approximately 2 mm can be positioned within the lumen of the electrode (3820).

[0114] Figure 38BThis is a schematic cross-sectional side view of a variant of the ablation device (3800) in the open configuration. The second catheter (3830) can be configured to translate relative to the first catheter (3810) via an actuation mechanism of the handle, as referenced herein. Figure 39A and 39B As stated above. Figure 36A An ablation device (3600) in a cutting configuration between an open configuration and a closed configuration is shown. The ablation device (3600) may correspond to the ablation device (3800).

[0115] In some variations, the proximal portion (3854) of the expander (3850) may include a first stepped portion including a first diameter and a second stepped portion including a second diameter larger than the first diameter. The first stepped portion may be adjacent to the second stepped portion. In some variations, the second step may include a mating surface (3856) configured to engage the distal end of the electrode (3820). In some variations, the mating surface (3856) may be substantially perpendicular to the longitudinal axis of the expander (3850). In some variations, the first step may be configured to engage the sidewall of the electrode (3820) when the expander (3850) engages the electrode (3820). In some variations, the expander (3850) may be configured to attach to a first conduit (3810) when the expander (3850) engages the electrode (3820).

[0116] electrode

[0117] Generally, the electrodes described herein can be configured to ablate tissue (such as a portion of a patient's atrial septum) to lower blood pressure in the patient's left atrium. In some variations, the electrodes may engage the septum and be energized to remove a portion of the septum tissue, thereby creating a predetermined opening between the left and right atria. For example, during electrosurgery, radiofrequency (RF) energy can be used to heat tissue. RF energy tissue ablation can be used to rapidly and precisely cut tissue without causing significant damage to surrounding tissue. In some variations, RF energy can be delivered to the tissue via electrodes to rapidly and precisely cut the tissue, thereby creating an anastomosis of a predetermined shape and size.

[0118] In some variations, the tissue ablation characteristics can be controlled by the size, shape, and / or geometry of the conductive region of the electrode. For example, the electrode may include a thin radial edge configured to apply high-density energy to a small contact surface area of ​​the tissue being ablated. This allows for rapid tissue ablation with less energy compared to electrodes with a larger contact surface area. In some variations, the distal end of the electrode may be angled (e.g., beveled, chamfered) relative to the longitudinal axis of the electrode to further reduce the contact surface area of ​​the electrode relative to the tissue. In some variations, the width of the chamfered surface may be between about 0.025 mm and about 0.040 mm, including all ranges and sub-values ​​therebetween. For example, the width of the chamfered surface may be between about 0.05 mm and about 0.08 mm.

[0119] Furthermore, the small contact surface area of ​​the electrodes can help compress tissue before ablation. For example, as... Figures 6A to 6C and Figures 9A to 9B As shown, the distal ends of the electrodes (620, 920) can be configured to abut against corresponding mating surfaces (654, ​​954). A smaller contact surface area of ​​the electrodes can increase the pressure applied to the mating surfaces of the tissue. Compression of the tissue between the electrodes and the mating surfaces can provide numerous benefits. For example, reducing the thickness of the tissue to be cut via compression allows the septum to be cut faster and with less energy. Furthermore, the compressed tissue can hold (e.g., fix, lock) the tissue in place relative to the ablation device to ensure that only a predetermined portion of the tissue is cut. In some variations, tissue compression during activation can fuse tissue layers (e.g., left and right atrial septa) together during ablation, thereby reducing the surface area of ​​exposed tissue along the periphery of the anastomosis after tissue removal. In some variations, tissue compression can be used to reduce the volume of the tissue, allowing a larger volume of tissue to be contained within the lumen of the electrodes after ablation, thus allowing for a relatively larger anastomosis.

[0120] In some variations, the shape of the opening in the atrial septum can be based on the shape of the electrodes. For example, respectively in Figure 4 and 8 The electrodes (420, 820) may include a tubular shape, which can be used to create a generally circular opening. In some variations, at least a portion of the distal end of the electrode may be angled from about 5 degrees to about 75 degrees relative to the longitudinal axis of the electrode to form a chamfer and / or bevel. For example, at least a portion of the distal end of the electrode may be angled from about 30 degrees to about 60 degrees relative to the longitudinal axis of the electrode. For example, respectively in Figure 6C and 7C The distal ends (628, 728) of the electrodes (620, 720) can be radially tilted at an angle of about 45 degrees relative to the longitudinal axis of the electrodes (620, 720).

[0121] As discussed herein, chamfered electrodes reduce the contact surface area of ​​the electrodes and allow for increased pressure on the tissue. In some variations, the corresponding mating surface of the expander may be similarly chamfered to facilitate alignment and coupling of the expander and electrode as the expander is withdrawn relative to the electrode. In some variations, at least a portion of the mating surface of the expander may be at an angle of about 5 degrees to about 75 degrees relative to the longitudinal axis of the expander. For example, at least a portion of the mating surface of the expander may be at an angle of about 30 degrees to about 60 degrees relative to the longitudinal axis of the expander. In this way, the chamfered electrode allows the expander itself to be positioned within the electrode by providing tolerance for misalignment between the electrode and the expander caused by, for example, tissue disposed therebetween.

[0122] In some variations, one or more portions of the electrode may be covered with an insulator (e.g., PTFE, ePTFE, PET, polyolefins, parylene, FEP, silicone, nylon, PEEK, polyimide) to reduce the electrode's contact surface area. A relatively small contact surface area can reduce bubble formation, as well as carbon formation and electrode activation time. In some variations, the inner surface of the electrode may remain uninsulated and serve as a conduction pathway for current through the contained tissue during and after tissue resection. In some variations, conduction through the tissue can reduce the volume of the resected tissue via protein drying and / or denaturation, thereby enabling the retention of a larger volume of tissue.

[0123] Figure 11A and 11B This is a schematic cross-sectional side view of the electrode (1110) of the ablation device (1100). Specifically, the distal end of the first catheter may include an electrode (1110) having a distal end (1120), an insulator (1130), a lead wire (1140), and a connector (1150). The electrode (1110) may have a tubular shape including the distal end (1120) and defining a lumen (1112). In some variations, the lumen (1112) may be configured to close one or more of barbs, tissue engaged by the barbs, and the proximal portion of a dilator. Figure 5A A cross-sectional perspective view of the lumen (522) is shown, and Figure 5B A portion of the barb (540) and expander (550) disposed within the lumen (522) is shown. Furthermore, as... Figure 22 As shown, the lumen (2222) can have a volume sufficient to surround a predetermined volume of tissue (2260). Similarly, Figure 27A and 27B It is an image containing a predetermined volume of tissue (2760) assembled within the lumen of electrode (2720). As yet another example, Figure 28A and 28BThe tissue (2860) shown is configured to be fitted within the lumen of an electrode (not shown). In some variations, the lumen may have a length of at least 1 mm. For example, the lumen may have a length between about 5 mm and about 4 cm.

[0124] In some variations, the connector (1150) may be coupled to each of the electrode (1110) and the wire (1140). An insulator (1130) may be configured to cover one or more of the outer surfaces of the electrode (1110) and the connector (1150). In some variations, the inner surface of the electrode (1110) may not be insulated. In some variations, up to about 2 mm of the outer surface of the electrode may not be insulated. For example, up to about 0.15 mm of the outer surface of the electrode may not be insulated.

[0125] like Figure 11B As shown in the detailed cross-sectional side view, the distal end (1120) of the electrode (1110) may be angled (e.g., chamfered, beveled) relative to the longitudinal axis of the electrode (1110). In some variations, the chamfer may extend radially along the distal end (1120). The distal end (1120) may include a single angle or multiple angles. For example, the surface of the distal end (1120) may include a sinusoidal shape, wherein the corresponding mating surface of the expander may include a corresponding sinusoidal shape. This allows the corresponding mating surfaces of the electrode and the expander to contact and compress each other in a predetermined orientation.

[0126] In some variations, the electrode may include one or more biocompatible metals, such as titanium, stainless steel, nitinol, palladium, silver, platinum, or combinations thereof. In some variations, the electrode may include a damage-resistant (e.g., blunt, rounded) distal edge so that the electrode does not puncture tissue when abutting against an opposing surface (such as the mating surface of an expander). For example, the electrode may engage and compress tissue along its chamfered circumferential edge.

[0127] In some variations, the cut tissue may include a diameter between approximately 1 mm and approximately 1.5 cm, encompassing all ranges and sub-values ​​therebetween. For example, the cut tissue may include a diameter between approximately 0.5 mm and approximately 12 mm. Alternatively, the cut tissue may include a diameter between approximately 6 mm and approximately 9 mm.

[0128] In some variations, heating the tissue can cause it to shrink before cutting. In some variations, heating the tissue can cause it to shrink after cutting. In some variations, the tissue can be heated to a predetermined temperature range. In some variations, the tissue to be cut can be heated to at least about 60°C, about 70°C, about 80°C, about 90°C, and about 100°C for a predetermined amount of time. In some variations, the tissue to be cut can be heated between about 50°C and about 100°C for a predetermined amount of time. In some variations, only the tissue to be cut can be heated, while in other variations, only a portion of the tissue to be cut can be heated. In some variations, the electrodes can be configured to rotate, oscillate, and / or vibrate during and after energy delivery to prevent, minimize, and / or disrupt char formation.

[0129] In some variations, the electrodes can be connected to the signal generator via wires (e.g., conductive wiring). The wires can extend from the proximal portion of the first conduit to the electrodes at the distal portion of the first conduit. One or more portions of the wires can be insulated. The wires can be configured to maintain a predetermined voltage potential without causing the corresponding insulating medium to break down.

[0130] Figure 12A and 12B These are perspective and front views of the connector (1200) of the ablation device. Figure 12C This is a cross-sectional side view of the connector (1200). In some variations, the connector (1200) may be configured to couple the electrode and the wire to the axis of the first conduit (not shown for clarity). The connector (1200) may include a lumen (1210) configured to slidably accommodate a second conduit and a channel (1220) configured for the distal end of the wire. In some variations, at least a portion of the inner surface of the connector (1200) may be smooth to facilitate translation of the second conduit relative to the connector (1200). For example, the inner surface of the connector (1200) may include a PTFE layer to facilitate smooth translation and / or rotation of the second conduit slidably disposed within the lumen (1210). In some variations, the connector (1200) may include a vent lumen (not shown) configured to drain fluid (e.g., air, heat, liquid) from the lumen of the electrode to the lumen of the first conduit.

[0131] In some variations, the connector (1200) may include a length of at least 0.1 mm. For example, the connector (1200) may include a length between about 1 mm and about 2 cm, and between about 2 mm and about 7 mm. In some variations, the lumen (1210) may include a length of at least 0.1 mm. For example, the lumen (1210) may include a length between about 1 mm and about 1 cm. In some variations, the channel (1220) may include a length of at least 0.1 mm. For example, the channel (1220) may include a length between about 1 mm and about 5 mm.

[0132] In some variations, the system disclosed herein may include a return electrode (e.g., an RF energy receiver) to extract RF energy from the patient. In some variations, the second catheter may include a return electrode. In some variations, the return electrode may be external to and in contact with the return electrode (e.g., a skin patch electrode, a grounding pad). For example, a set of return electrodes may be positioned on the patient's back to allow current to flow from the electrodes through the patient and then to the return electrode. For example, one or more return electrodes may be positioned on the patient's skin. A conductive gel may be applied between the return electrode and the skin to improve contact.

[0133] insulator

[0134] Generally, the insulator described herein can be configured as one or more parts of the electrodes and / or conduits of an electrically isolated ablation device. In some variations, the insulator may include one or more of the following: poly(p-xylene) polymers (e.g., parylene C, parylene N), polyurethane (PU), polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyimide (PI), polyester, polyethylene terephthalate (PET), PEEK, polyolefins, silicone resins, copolymers, ceramics, and combinations thereof.

[0135] barbs

[0136] Generally, the barbs described herein can be configured to engage tissue (such as a patient's atrial septum) to control the size and shape of the atrial septum tissue to be cut. In some variations, a portion of the septal tissue can be engaged by one or more protrusions of the barb and stretched across one or more protrusions before and after tissue ablation to hold the tissue in place. In some variations, the protrusions can be configured to penetrate or pass through the tissue by a predetermined distance. For example, the protrusions can be configured to penetrate multiple layers of the atrial septum (e.g., one or more layers of the left and right atria) to secure the septal tissue to the barb while maintaining the overall structural integrity of the septum. In some of these variations, the protrusions penetrating the tissue can hold the tissue on the barb to reduce shear strain as the tissue is pulled into the electrode, thereby improving the consistency and shape (e.g., cylindricity) of the cut. That is, the barbs can be configured to capture but not tear the tissue, allowing the tissue to remain engaged by the barbs throughout the electrosurgical procedure.

[0137] For example, barbs can be configured to prevent tearing by distributing pressure when the tissue is engaged and pulled. For example, the engaged tissue can be formed into a generally conical tent shape over the barbs to apply tension to the septum. In some variations, the barbs can be configured to provide counter-tension to the interatrial septum during electrode energization to minimize any unintended tissue deformation, rotation, and displacement due to unbalanced forces (e.g., tissue movement due to heartbeat). The engaged tissue and barbs can be withdrawn into the lumen of the ablation device to hold and fix the tissue during tissue ablation. In some variations, the size of the anastomosis can depend on the distance the barbs are withdrawn into the electrode, such that the size of the anastomosis is independent of the diameter of the ablation device. This allows an ablation device with electrodes of a fixed diameter to form anastomosis with a diameter larger than that of the electrode. The size (e.g., diameter, length) and shape of the barbs should allow them to fit within the lumen of the electrode when engaged with the tissue. In some variations, the diameter of the opening in the tissue can be calculated using equation (1):

[0138]

[0139] Where D is the diameter of the opening, d is the inner diameter of the electrode, and z is the distance the tissue is pulled into the electrode.

[0140] Figures 13A to 13CVarious views of the barb (1300) of the ablation device are depicted. The barb (1300) may include a base (1310) and one or more protrusions (1320) (e.g., tips), said one or more protrusions having a proximal end including a tissue-engaging portion (1322) (e.g., a tip). The base (1310) may be generally cylindrical and configured to couple to the proximal portion of the dilator and the axis of a second catheter (not shown). For example, the base (1310) may be located near the dilator of the second catheter.

[0141] One or more of the protrusions (1320) may be coupled to the proximal end of the base (1310). In some variations, the protrusions (1320) may include elongated elements. For example, a barb (1300) may include at least one protrusion (1320). In some variations, the protrusions (1320) may be substantially equidistant from the circumference of the base (1310). In some variations, each of the protrusions (1320) may have the same or different lengths. In some variations, the length of the barb (1300) may be between about 0.1 mm and about 5 cm. In some variations, one or more of the protrusions (1320) may be linear, curved, wavy, circular, arcuate, etc.

[0142] In some variations, the protrusion (1320) may include one or more tissue engagement portions (1322). The tissue engagement portions (1322) and / or the protrusion (1320) may be configured to engage tissue without tearing it, thus preventing loss of tissue integrity. In some variations, the tissue engagement portions (1322) may be configured to puncture or penetrate tissue. In some variations, the geometry and size of each tissue engagement portion (1322) may be the same or different. For example, the tissue engagement portion (1322) may include a sharp point or a blunt, injury-resistant end. In some variations, the tissue engagement portion (1322) may include one or more secondary structures (e.g., serrations) to prevent tissue from slipping off the protrusion (1320). In some variations, the tissue engagement portion (1322) may include an angle of about 10 degrees to about 90 degrees relative to the longitudinal axis of its protrusion (1320). In some variations, the length of the protrusion (1320) and / or the tissue junction portion (1322) may be between about 0.1 mm and about 2 cm.

[0143] In some variations, the protrusion (1320) may be generally linear, but may be angled relative to the longitudinal axis of the base (1310). For example, the protrusion (1320) may be configured to open outward to grasp and engage tissue. In some variations, the protrusion may include one or more curved or angled portions. In some variations, tissue may be configured to engage one or more portions of the protrusion (1320). In some variations, the barbed protrusion may be at an angle of about 5 degrees to about 60 degrees relative to the longitudinal axis of the base (1310), including all values ​​and subranges therebetween. For example, the protrusion (1320) may include angles between about 30 degrees and about 45 degrees. Each protrusion (1320) may have the same angle or different angles relative to the longitudinal axis.

[0144] In some variations, the protrusion (1320) may be configured to engage tissue of a predetermined length and / or volume. For example, the protrusion (1320) may include a proximal portion configured to act as a barrier (e.g., a stop, a wall) to block additional tissue engagement (e.g., advancement, penetration), thereby reducing tissue tearing.

[0145] Figure 14 This is a schematic side view of the barb (1400) of the ablation device. The barb (1400) may include a base (1410) and one or more protrusions (1420), said one or more protrusions having a proximal end including a tissue-engaging portion (1422). The protrusions (1420) of the barb (1400) may be arranged in accordance with... Figures 13A to 13C The barb (1300) is angled in a similar manner. In some variations, the barb may include approximately 2 to approximately 12 protrusions, including all values ​​and subranges in between. For example, the barb may include approximately 5 to approximately 7 protrusions.

[0146] Figure 15A This is a schematic side view of the barb (1500) of the ablation device. Figure 15B This is a front view of the barb (1500). The barb (1500) may include a base (1510) and one or more protrusions (1520, 1530), each protrusion having a respective proximal end, each proximal end including a respective tissue engagement portion (1522, 1532). In some variations, the one or more protrusions (1520, 1530) may be arranged in rows along the length of the barb (1500). For example, the barb (1500) may include one or more rows of protrusions (1520, 1530). In some variations, the rows of protrusions (1520, 1530) may be staggered, such as... Figure 15A and 15B As shown in the diagram. The tissue joined to the barbs (1500) can form a generally conical tent-like shape.

[0147] Figure 16 This is a schematic side view of the barb (1600) of the ablation device. The barb (1600) may include a base (1610) and one or more protrusions (1620), the one or more protrusions having a proximal end including a tissue-engaging portion (1622). The protrusions (1620) may be parallel to the longitudinal axis of the base (1610). Figure 17A and 17B These are schematic side and perspective views of the barb (1700) of the ablation device. The barb (1700) may include a base (1710) and one or more protrusions (1720), the one or more protrusions having a proximal end including a tissue-engaging portion (1722). The tissue-engaging portion (1722) may extend along a large portion of the length of the protrusion (1720). In some variations, the base (1610) may include a diameter smaller than the diameter of the electrode. In some variations, the protrusions (1620, 1720) and the tissue-engaging portions (1622, 1722) may include a length configured to puncture the interatrial septum. The one or more tissue-engaging portions (1722) may include, for example, Figure 17A and 17B The length shown can help to puncture and / or penetrate tissue with reduced force due to the increased taper.

[0148] Figure 41A and 41B These are schematic side and perspective views of the barb (4100) of the ablation device. The barb (4100) may include a base (4110) and one or more protrusions (4120), the one or more protrusions having a proximal end including a tissue-engaging portion (4122). In some variations, the protrusions (4120) and the tissue-engaging portion (4122) may include a length configured to pierce the interatrial septum. The one or more tissue-engaging portions (4122) may include, for example... Figure 41A and 41B The length shown can help puncture and / or penetrate tissue.

[0149] Figures 26A to 26CVarious views of the barb (2600) of the ablation device are depicted. The barb (2600) may include a base (2610) and one or more protrusions (2620) (e.g., tips, serrations). The protrusions (2620) may include a first portion (2624) and a distal portion (e.g., a tissue-jointing portion) (2622) (e.g., a tip, apex). In some variations, the first portion (2624) may be angled relative to the second portion (2622). For example, the protrusion (2620) may include a bend in which the first portion (2624) is substantially perpendicular to the second portion (2622). The base (2610) may be generally cylindrical and configured to couple to the proximal portion of the dilator and the axis (not shown) of the second catheter. For example, the base (2610) may be close to the dilator of the second catheter.

[0150] One or more of the protrusions (2620) may be coupled to one end of the base (2610). In some variations, the protrusions (2620) may include elongated elements. For example, a barb (2600) may include at least one protrusion (2620). In some variations, the protrusions (2620) may be substantially equidistant around the circumference of the base (2610) and extend away from the longitudinal axis of the base (2610). In some variations, each of the protrusions (2620) may have the same or different lengths. In some variations, the length of the barb (2600) may be between about 0.1 mm and about 5 cm. In some variations, the ratio of the length of the proximal portion to the length of the distal portion may be between about 2:3 and about 1:5. In some variations, one or more of the protrusions (2620) may be linear, curved, wavy, circular, arcuate, etc. For example, the protrusion (2610) may include an "L" shape, a "J" shape, or a "C" shape, wherein the diameter defined by the protrusion (2610) together is larger than the diameter of the base (2610).

[0151] In some variations, the distal portion (2622) of the protrusion (2620) may include one or more tissue-engaging portions (2622). The tissue-engaging portions (2622) and / or the protrusion (2620) may be configured to engage tissue without tearing it, thus preventing loss of tissue integrity. In some variations, the tissue-engaging portions (2622) may be configured to puncture or penetrate tissue. In some variations, the geometry and size of each tissue-engaging portion (2622) may be the same or different. For example, the tissue-engaging portion (2622) may include a sharp point or a blunt, injury-resistant end. In some variations, the tissue-engaging portion (2622) may include one or more secondary structures (e.g., serrations) to prevent tissue from slipping off the protrusion (2620). In some variations, the tissue-engaging portion (2622) may be substantially parallel to the longitudinal axis of the base (2620). In some variations, the length of the protrusion (2620) may be between about 0.1 mm and about 2 cm. For example, the protrusion (2620) may include a length between about 1.25 mm and about 1.75 mm and about 1.5 mm. In some variations, the length of the tissue junction portion (2622) may be between about 1.0 mm and about 1.5 mm, including all ranges and sub-values ​​therebetween.

[0152] In some variations, the protrusion (2620) may be generally linear, but may include one or more bends. For example, a first portion (2624) of the protrusion (2620) may be configured to extend substantially perpendicular to the longitudinal axis of the base (2620). In some variations, the protrusion may include one or more bends or angled portions between the first portion (2624) and the second portion (2622). In some variations, tissue may be configured to engage one or more portions of the protrusion (2620).

[0153] In some variations, the first portion (2624) of the protrusion (2622) may form an angle of about 60 degrees to about 120 degrees relative to the longitudinal axis of the base (2610), including all values ​​and subranges therebetween. For example, the protrusion (2620) may include an angle of about 80 degrees to about 100 degrees relative to the longitudinal axis of the base (2610). Figure 26A As shown, the first portion (2624) may be substantially perpendicular to the longitudinal axis of the base (2610). Each first portion (2624) of the protrusion (2620) may have the same or different angles relative to the longitudinal axis. In some variations, the second portion (2622) of the protrusion (2620) may form an angle of up to about 30 degrees relative to the longitudinal axis of the base (2610). For example, as Figure 26A As shown, the second part (2622) can be substantially parallel to the longitudinal axis of the base (2610).

[0154] In some variations, the protrusion (2620) can be configured to engage tissue of a predetermined length and / or volume. For example, a second portion (2622) can engage and pierce the tissue, while a first portion (2624) can engage the tissue and secure it to the barb (2600). The second portion (2622) can be configured to pierce the tissue such that the layers of the interatrial septum (e.g., left and right atrial layers) remain together to reduce tissue separation and / or tissue shearing. For example, the protrusion (2620) can be configured to penetrate the layers of the septum and pin them together to reduce relative shearing of the septal tissue layers during translation, thereby reducing the chamfer of the anastomosis to be formed. The first portion (2624) can also be configured as a barrier (e.g., stop, wall) to block additional tissue engagement (e.g., advance, penetration), thereby reducing tissue tearing. When the barb is withdrawn into the lumen of the electrode, the predetermined volume of tissue can be captured by the protrusion (2620).

[0155] In some variations, the barb may include between about 3 and about 12 protrusions, including all values ​​and subranges therebetween. For example, the barb may include between about 3 and about 7 protrusions. In some variations, multiple tissue engagement portions (2622) may extend from the same first portion (2624), which may collectively include, for example, a set of concentric rings. In some variations, the set of protrusions may be staggered. Tissue engaged with the barb (2600) may form a generally conical or cylindrical tent-like shape. In some variations, the tissue engagement portion (2622) may extend along most of the length of the protrusion (2620). In some variations, the base (2610) may include a diameter smaller than the diameter of the electrode.

[0156] In some variations, the barbs can be configured to change from a compressed configuration to an expanded configuration. For example, when positioned within the lumen of the electrode, the barbs can be in a compressed configuration. When advancing the second catheter relative to the first catheter, the barbs can change to an expanded configuration, allowing them to extend beyond the lumen of the electrode and thus enabling them to engage with a large amount of tissue.

[0157] In some variations, the barbs can be configured to engage tissue for cutting by rolling the barbs (2920) at a predetermined angle. Figure 29A , 29BFigure 29C is a side view of the barb (2920) of an ablation device (2900) in the endocardial space. The ablation device (2900) may include a catheter (2910) (e.g., a distal tip, a dilator) and a barb (2920). The barb (2920) may include a base (2926) and one or more protrusions (e.g., a point, a serration), said one or more protrusions including a second portion (e.g., a tissue-jointing portion) (2922) (e.g., a tip, a cusp) and a first portion (2924).

[0158] In some variations, the second portion (2922) (e.g., a tissue-joining portion) can be configured to join tissue (2930) without tearing the tissue to prevent loss of tissue integrity. In some variations, the second portion (2922) can be configured to puncture or penetrate the tissue. Figure 29A The initial penetration of the second part (2922) into the tissue (2930) is depicted. As the barb (2920) advances towards the tissue (2930), Figure 29B The entire thickness of the second part (2922) penetrating the tissue (2930) (e.g., the interatrial septum) is depicted.

[0159] In some variations, the size (e.g., diameter) of the tissue to be cut (2930) can be controlled by rolling up (e.g., twisting) the barb (2920) around its base (2926) along a longitudinal axis (2921). For example, the barb (2920) is rolled up after engagement with the tissue (2930). Figure 29B This can increase the amount of tissue (2930) that joins to the barb (2920) to be cut. For example... Figure 29C As shown, as the barbs are rolled up, the tissue (2930) can be pulled (e.g., compressed) (2932) toward the longitudinal axis (2921) via the arrow (2932). This allows the diameter (2934) of the tissue to be cut (2930) to be larger than the diameter of the barbs (2920). In some variations, twisting the barbs can increase the diameter of the tissue to up to about 5 mm, up to about 3 mm, and up to about 1 mm, including all ranges and sub-values ​​in between.

[0160] In some variations, the barb (2920) can be configured to curl up to about 30 degrees, about 45 degrees, about 60 degrees, about 90 degrees, about 180 degrees, about 270 degrees, about 360 degrees, about 720 degrees, about 1,080 degrees, between about 90 degrees and about 720 degrees, and between about 180 degrees and about 360 degrees, including all ranges and sub-values ​​in between.

[0161] In some variations, the handle of the device can be configured to control the rotation of the barbs (2920) and / or the catheter (2910), and thus to control the size of the tissue to be cut (2930). In some variations, the proximal portion of the ablation device (e.g., the first catheter) can be fixed relative to the distal portion of the ablation device (e.g., the barbs (2920) and the catheter (2910)).

[0162] In some variations, the first part (2924) can be in accordance with the reference in this text. Figures 26A to 26C The manner described in the detailed description is similar, forming an angle with respect to the second part (2922). In some variations, the protrusion may include a curved portion, wherein the first part (2924) forms an acute angle with respect to the second part (2922). For example, as... Figures 29A to 29C As shown, the first portion (1924) forms an acute angle with respect to the longitudinal axis (2921) of the base (2926). The base (2926) may be generally cylindrical and may be configured to couple to the proximal portion of the catheter (2910) (e.g., a second catheter, a distal catheter). For example, the base (2926) may be located near the dilator ( Figures 29A to 29C (Not shown in the image).

[0163] In some variations, the barb can be configured to translate relative to the expander (3030) to transition between a first configuration (e.g., a recessed configuration) and a second configuration (e.g., an extended configuration). Figure 30A and 30B This is a cross-sectional side view of the distal portion of an ablation device (3000), which includes a catheter (3010) (e.g., a second catheter), a barb (3020), and a distal tip (3030) (e.g., a dilator). In some variations, the catheter (3010) and / or the dilator (3030) may include one or more lumens (3012). For example, a guidewire (not shown) may be configured to be slidably disposed within the lumen (3012) and / or other catheters (3010). In some variations, the dilator (3030) may define a recess (3040) configured to retain (e.g., surround, enclose) the barb (3020). That is, the barb (3020) may be configured to be disposed within the recess (3040). For example, the length of the recess (3040) may be at least equal to the length of the barb (3020), such that the entire barb (3020) can be fitted within the recess (3040). In some variations, the groove (3040) may be defined within the proximal end of the expander (3030).

[0164] Figure 30AAn ablation device (3000) in a first configuration is shown, wherein a barb (3020) is arranged within a groove (3040) of a dilator (3030). In the first configuration, the barb (3020) can be protected from contact with tissue, which is useful when the catheter (3010) and dilator (3030) are advanced through the patient's body. Figure 30B An ablation device (3000) in a second configuration is shown, wherein barbs (3020) are arranged outside a groove (3040) of an expander (3030). In the second configuration, the barbs (3020) can be configured to engage tissue, as described in detail herein.

[0165] In some variations, the handle of the device can be configured to control the translation of the barbs (3020) and / or the catheter (3010) relative to the dilator (3030), and thus to control the size of the tissue to be cut. For example, the barbs (3020) extending from the dilator (3030) can support the joined tissue and increase the diameter of the tissue to be cut by the ablation device (3000). In some variations, the position of the ablation device (e.g., a catheter including electrodes) and the proximal portion of the dilator (3030) can be fixed relative to the translational barbs (3020). For example, after the dilator (3030) has been advanced through the interatrial septum, the barbs (3020) can be changed from a first configuration to a second configuration.

[0166] In some variations, the barbs can be formed to have sufficient strength to hold the structure in place without breaking. The barbs can include one or more of the following: stainless steel, nickel-titanium, platinum, polyvinyl chloride (PVC), polyethylene (PE), cross-linked polyethylene, polyolefins, polyolefin copolymers (POC), polyethylene terephthalate (PET), polyester, nylon, polymer blends, polyester, polyimide, polyamide, polyurethane, silicone, polydimethylsiloxane (PDMS), PEBAX, and combinations thereof.

[0167] Additionally or alternatively, barbs may include one or more of the following: spiral, helical, open-end, and coil shapes. Figure 40A It is a side view, and Figure 40B This is a perspective view including a barb (4000) in a double-helix shape. The barb (4000) may include a base (4010), a first protrusion (4020), and a second protrusion (4022). The protrusions (4020, 4022) may each include a distal tip configured to puncture (e.g., penetrate) tissue. For example, the barb (4000) may be configured to rotate (e.g., helically rotate) into the tissue. The protrusions (4020, 4022) may have the same or different shapes and sizes. In some variations, the catheter may be configured to rotate about a longitudinal axis so that the barb (4000) can twist and engage tissue. (Referring to...) Figures 29A to 29C As described in detail, the rotation of the barbs can control the diameter of the tissue to be cut.

[0168] In some variations, the barbs may include a set of concentric rings along the length of the second duct. For example, the barbs may include a set of rings, each with a thin radial edge configured to engage tissue. The open tissue engaged by the barbs may be configured to form a generally conical or cylindrical shape. In some variations, at least a portion of the barbs may include a textured or rough surface configured to facilitate tissue engagement. In other variations, the barbs may include a stepped structure. In some variations, the protrusions may include a mesh consisting of one or more struts. For example, the mesh may be arranged radially around the second duct and flared outwards.

[0169] Visual features

[0170] In some variations, the ablation devices and systems described herein may include one or more visualization features for indirect visualization of the ablation device. For example, visualization features and techniques may facilitate one or more of the imaging, positioning, alignment, and manipulation of the intracavitary ablation device. For example, indirect visualization techniques may include, but are not limited to, ultrasound, fluoroscopy, and X-rays. As described in detail herein, fluoroscopic visualization elements enable catheters to be aligned with tissues and with each other.

[0171] In some variations, techniques such as ultrasound and fluorescence fluoroscopy can be used to visualize features during the operation of the ablation system. For example, contrast agents can be used to visualize one or more components of the ablation device and their position and / or orientation relative to tissue (such as the interatrial septum). In some variations, contrast agents (e.g., contrast media) may comprise one or more agitated saline solutions and microbubbles (e.g., CO2). In particular, microbubbles can be used in conjunction with ultrasound examinations (e.g., ultrasound), such as echocardiography. For example, when receiving ultrasound energy, microbubbles can oscillate and vibrate, and reflect ultrasound waves. Microbubbles introduced into body cavities can enhance image contrast at the interfaces between tissue, blood, and the ablation device.

[0172] In some variations, microbubbles may include a shell and a core. For example, the microbubble shell may include one or more of albumin, galactose, protein, lipid, polymer, or combinations thereof. The microbubble core may include one or more of air, nitrogen, perfluorocarbon, or combinations thereof.

[0173] Generally, microbubbles can have diameters between about 1 μm and about 1 mm, about 1 μm and about 5 μm, about 1 μm and about 10 μm, about 10 μm and about 50 μm, about 50 μm and about 0.1 mm, about 0.1 mm and about 0.5 mm, and about 0.5 mm and about 1 mm, including all ranges and sub-values ​​therebetween.

[0174] In some variations, the ablation device described herein can be configured to output microbubbles for indirect visualization. Figure 31A This is a side view of an ablation device (3100) including a first catheter (3110), an electrode (3120), and a dilator (3150). In some variations, the dilator (3150) may include one or more fluid ports (3160) configured to deliver microbubbles. That is, when the ablation device (3100) is in the closed configuration as described in detail herein, microbubbles may be introduced (e.g., injected) into a body cavity. Figure 31A Multiple fluid ports (3160) are shown arranged radially around the proximal circumference of the expander (3150). In some variations, microbubbles may be delivered within the lumen of the electrode (3120) and configured to flow out of one or more fluid ports (3160) to the outside of the ablation device (3100).

[0175] Additionally or alternatively, the electrode (3120) may include one or more fluid ports, as per [reference to...]. Figure 42A and 42B For more detailed discussion, for example, the distal end of the electrode may include one or more openings (e.g., openings, slits, channels, grooves, ridges) configured to output microbubbles. In some variations, any portion of the electrode (3120) may include a fluid port (3160).

[0176] Figure 31B This is a cross-sectional side view of an ablation device (3100) including a first catheter (3110), an electrode (3120), a second catheter (3130), a barb (3140), and a dilator (3150). Figure 31B The closed-configuration ablation device (3100) shown depicts barbs (3140), microbubbles (3170), and the proximal end of a dilator (3150) enclosed within the lumen of an electrode (3120). One or more of the first catheter (3110) and the second catheter (3130) can be configured to open from the corresponding contrast agent lumen ( Figure 31B (Not shown) Output contrast agent (3170) (e.g., microbubbles). For example, the contrast agent (3170) may be output into the lumen of the electrode (3120) and then flow out of the ablation device (3100) via the fluid port (3160).

[0177] In some variations, when the ablation device (3100) is in a closed configuration, contrast agents (e.g., microbubbles) can be introduced (e.g., injected) into the lumen of the electrode (3120) and then into the body cavity. Figure 31CThis is a detailed cross-sectional side view of the ablation device (3100). In some variations, the expander (3150) may include a mating surface (3152) configured to close the distal end of the coupled electrode (3120), in a manner similar to, for example, regarding... Figures 6A to 6C And in the manner described in 9A to 9B. Figure 31C As shown, contrast agent (3170) can be configured to flow between the inner diameter of the electrode (3120) and the outer diameter of the proximal end of the dilator (3150), and out of the fluid port (3160). Thus, contrast agent (3170) can be output from the ablation device (3100) through the fluid port (3160). If the mating surface is not pressed against the electrode (3120) (e.g., withdrawn by the operator at the handle where preload was applied), the ablation device (3100) can be configured to output microbubbles from the fluid port (3160). Therefore, one or more fluid ports (3160) of the dilator (3150) can be configured to output contrast agent (3170) received from the lumen of the electrode (3120).

[0178] Figure 31D , 31E Figures 31F and 31F are perspective views of the distal portion of an ablation device (3100) including a first catheter (3110), an electrode (3120), a second catheter (3130), a barb (3140), and a dilator (3150). The ablation device (3100) is configured in an open configuration to facilitate the various fluid port configurations (3160, 3162, 3164) of the illustrated dilator (3150). The fluid ports (3160, 3162, 3164) can be configured to allow contrast agents (e.g., microbubbles) to flow from the lumen of the electrode (3120) to the outside of the ablation device (3100). Without the fluid ports (3160, 3162, 3164), when the ablation device (3100) is in a closed configuration, the contrast agents can be sealed within the lumen of the electrode (3120), thus requiring the electrode (3120) to be separated from the dilator (3150). In contrast, the fluid port (3160) allows contrast agents to flow from the closed configuration into the body cavity.

[0179] In some variations, the fluid port (3160) may include a shape including, but not limited to, an opening, a slit, a channel, a groove, a ridge, a hole, or a combination thereof. Figure 31D A fluid port (3160) configuration is shown, which includes a plurality of longitudinal channels disposed along the proximal portion of the expander (3150), the plurality of longitudinal channels being close to the mating surface (3152) of the expander (3150). Figure 31E A fluid port (3162) configuration is shown, which includes a plurality of grooves disposed within the mating surface (3152) of the expander (3150). Figure 31F It shows including Figure 31D longitudinal channels and Figure 31E The combination of grooves in the fluid port (3164) configuration. In some variations, the ablation device (3100) may include one or more fluid ports (3160). For example, the ablation device (3100) may include up to about 3 fluid ports, up to about 5 fluid ports, up to about 7 fluid ports, up to about 10 fluid ports, up to about 20 fluid ports, up to about 50 fluid ports, up to about 75 fluid ports, and up to about 100 fluid ports, including all values ​​and subranges therein.

[0180] like Figure 42A and 42B As shown, the electrode (4200) may include one or more fluid ports (4220). For example, the distal end (4210) of the electrode (4200) may include one or more fluid ports (4220) (e.g., openings, apertures, slits, channels, grooves, ridges, outlets), said one or more fluid ports being configured to output fluid (e.g., contrast agents, contrast media, microbubbles). For example, the fluid port (4220) may include a diameter at least as large as the diameter of the microbubble to allow the microbubble to pass through it. In some variations, the fluid ports of the electrode (4200) may be aligned with or offset from the fluid ports of an expander. In some variations, the fluid ports described herein may be formed via laser cutting. In some variations, any portion of the electrode (4200) may include a fluid port (4220).

[0181] Figure 33A This is a side view of the distal portion (3310) of the ablation device (3300) (e.g., dilator, distal tip). Figure 33B This is a cross-sectional side view. In some variations, the expander (3310) may include a lumen (3312), a proximal end (3314), a mating surface (3316), and one or more visual features (3320, 3222). In some variations, the visual features (3320, 3222) may correspond to the echo zone.

[0182] In some variations, the echo region may include one or more microspheres, grooves, protrusions, channels, trenches, scratches, edges, indentations, blind holes, mountain and valley shapes, undercuts, or combinations thereof. For example, one or more microspheres, grooves, or protrusions may have diameters between about 5 μm and about 100 μm. In some variations, the microspheres may include a gas core. The microspheres may include glass.

[0183] In some variations, the echo region may include one or more sections of the expander. For example, Figure 33A and 33BThe proximal portion (3314) without visual features (3320, 3222) is shown. In some variations, the echo region may include multiple texture patterns. For example, a first texture pattern may be arranged along the distal end of the expander (3310), and a second texture pattern may be arranged along the proximal end of the expander (3310). This can help identify different portions of the expander (3310). In some variations, the texture pattern may include shapes including, but not limited to, circular, radial, crosshairs, random, linear, curved, spiral, oval, elliptical, sinusoidal, polygonal, nonlinear, and combinations thereof.

[0184] In some variations, the echo region may include the density of visual features (e.g., grooves, protrusions, etc.) between about 5% and about 50%, between about 10% and about 40%, between about 20% and about 30%, between about 5% and about 10%, between about 10% and about 20%, between about 30% and about 40%, and between about 40% and about 50% (inclusive of all values ​​and subranges therebetween).

[0185] In some variations, the echo region may be on and / or beneath the surface of the expander (3310). For example, Figure 33A A schematic diagram (e.g., not to scale) depicts a plurality of microspheres formed on the top of the surface of the expander (3310). In some variations, the echo region may include one or more surface textures or patterns on the surface of the expander (3310). In some variations, the surface texture of the echo region may be produced using one or more of the following: sandblasting, laser engraving, grinding trimming, grooving, etching, deposition, and combinations thereof on an injection mold.

[0186] Figure 33B A schematic diagram depicts multiple microspheres formed beneath the surface of an expander (3310). In some variations, the expander (3310) may be heat-treated (e.g., encapsulated) to generate one or more microspheres beneath the surface of the expander (3310). For example, heating the expander (3310) to above the melting temperature of the material (e.g., plastic) can induce microbubble formation of pore contents beneath the surface of the expander through the evaporation of volatile compounds. In some variations, the expander may be formed using microspheres, such as glass beads, arranged beneath the surface of the expander (3310). In some variations, a high-temperature heat source (e.g., flame, laser) may be used to treat the surface of the expander (3310) with short pulses (e.g., subseconds), which may melt the surface but not penetrate the entire thickness of the expander (3310). Additionally or alternatively, glass microspheres may be incorporated into a base resin material that is injection molded to form the expander (3310).

[0187] Additionally or alternatively, fluoroscopy is a technique for real-time X-ray imaging and can be used to guide catheter insertion and movement through blood vessels. Generally, in fluoroscopy, an X-ray beam is emitted from a fluorometer and passes through the area of ​​interest in the body. An image intensifier can be used to image the object to be visualized (e.g., an ablation device). A user observing the real-time image displayed by the image intensifier can then determine the orientation and alignment of the catheters relative to each other.

[0188] In some variations, one or more of the first and second catheters may include a metal-based radiopaque marker, which includes one or more of a ring, a band, and an ink (e.g., platinum, platinum-iridium, gold, nitinol, palladium), and the metal-based radiopaque marker is configured to allow observation under a fluorescence microscope.

[0189] The ablation device described herein may include any radiopaque metal, such as tungsten, platinum-iridium, stainless steel, titanium, as well as tungsten-filled polymers, zirconia ceramics, or any suitable radiopaque material. The visualization feature may be located at any suitable location on or within the catheter (e.g., one or more outer surfaces of the device, the interior of the catheter, etc.). In some variations, one or more portions of the ablation device may be made of a radiopaque material, or the visualization feature may be attached to the device by any suitable method, such as mechanical attachment (e.g., embedding in a portion of the catheter, circumferential restraint, etc.), bonding, welding, brazing, or a combination thereof.

[0190] sensor

[0191] In some variations, the ablation devices and systems described herein may include one or more sensors. Generally, the sensors described herein can be configured to receive and / or transmit signals corresponding to one or more parameters. In some variations, the sensors may include one or more of the following: pressure sensors, temperature sensors, electrical sensors (e.g., impedance sensors, voltage sensors for sensing signals such as electromyography, electrocardiography, etc.), magnetic sensors (e.g., RF coils), electromagnetic sensors (e.g., infrared photodiodes, optical photodiodes, RF antennas), force sensors (e.g., strain gauges), flow or velocity sensors (e.g., hot-wire anemometers, vortex flowmeters), acceleration sensors (e.g., accelerometers), chemical sensors (e.g., pH sensors, protein sensors, glucose sensors), oxygen sensors (e.g., pulse oximetry sensors, myocardial oxygen consumption sensors), audio sensors (e.g., microphones for detecting heart murmurs, auscultation), sensors for sensing other physiological parameters (e.g., sensors for sensing heart wall motion, heart rate, respiratory rate, arrhythmia), stimulators (e.g., for stimulation and / or pacing functions), combinations thereof, etc. In some variations, impedance sensors can be configured to monitor the impedance between the electrode and the return electrode to confirm the completion of tissue resection.

[0192] guide wire

[0193] In some variations, the guidewire is slidably disposed within the ablation device and configured to pass through the interatrial septum (e.g., using a standard transseptal puncture technique). In some variations, the first and second catheters of the ablation device can be translated relative to each other and / or the interatrial septum along the guidewire. For example, the guidewire may comprise one or more of stainless steel, nitinol, platinum, and other suitable biocompatible materials.

[0194] catheter

[0195] Generally, the catheters described herein can be configured to deliver electrodes and barbs to one or more cardiac chambers for cutting tissue, such as the atrial septum. In some variations, the catheter may include an axle composed of a flexible polymeric material such as Teflon, nylon, polyether block amide (Pebax), or combinations thereof. In some variations, the ablation device may include one or more maneuverable or deflectable catheters (e.g., unidirectional, bidirectional, four-directional, omnidirectional). In some variations, the first catheter may include one or more traction wires configured to maneuver or deflect a portion of the first catheter. In some variations, the first catheter may have a bending radius between about 45 degrees and about 270 degrees. In some variations, the second catheter described herein defines the lumen through which the guidewire can pass.

[0196] In some variations, the catheter may be braided and / or knotted and made of a material (e.g., nylon, stainless steel, polymer) configured for catheter maneuverability and flexibility. In some variations, the first catheter may include a predetermined bend shape configured to guide the second catheter to the diaphragm at a predetermined orientation and angle.

[0197] Figure 34A and 34B This is a cross-sectional side view of the distal end of the first catheter (3410) of the ablation device (3400). In some variations, the distal portion of the first catheter (3410) may include a predetermined bend (e.g., a pre-bent tip), such as... Figure 34A As shown in the diagram. For example, a predetermined bend may allow the distal end of the first catheter (3410) to be oriented at a predetermined angle relative to tissue (e.g., interatrial septum). In some variations, the predetermined bend may include an angle between about 30 degrees and about 70 degrees.

[0198] In some variations, the distal portion of the first catheter (3410) can be positioned and / or oriented (e.g., substantially perpendicular to the tissue wall) by deflecting the first catheter (3410) (e.g., controlling the bending of the first catheter). In some variations, a first catheter actuator (3430) can be configured to deflect the distal portion of the first catheter (3410) while also electrically coupling an electrode (3430) to a signal generator (not shown). In this way, the first catheter actuator (3430) can also function as a traction line configured to manipulate the first catheter (3410) and deliver energy to the electrode (3420).

[0199] In some variations, the ablation device (3400) may include a first catheter (3410), an electrode (3420) coupled to the distal end of the first catheter (3410), and a first catheter actuator (3430) coupled to the electrode (3420). For example, the first catheter actuator (3430) may be electrically coupled to the electrode (3420). In some variations, the first catheter actuator (3430) may be coupled (e.g., fixed, welded, laser-welded) to the inner surface of the electrode (3420). Thus, pulling the first catheter actuator (3430) allows a predetermined amount of tension to be applied to the distal portion of the first catheter (3410). The first catheter actuator (3430) may have a longitudinal axis offset and parallel to the central longitudinal axis (not shown) of the first catheter (3410). Pulling the first catheter actuator (3430) can generate a bending moment between the central longitudinal axis of the first catheter (3410) and the radius of the first catheter actuator (3430) coupled to the electrode (3420).

[0200] The electrode (3420) can be configured to ablate tissue using current delivered from a signal generator through an electrical conductor (e.g., wire wiring) of the first catheter actuator (3430). In some variations, the first catheter actuator (3430) may include a traction wire extending along the length of the first catheter (3410). The proximal end of the first catheter actuator (3430) may be configured to couple to an actuation mechanism. For example, a handle may include the actuation mechanism configured to manipulate the first catheter (3410) via the first catheter actuator (3430). That is, tension and / or pressure may be applied to the first catheter actuator (3430) to deflect (e.g., change the angle) the distal portion of the first catheter (3410), such as... Figure 34B As shown in the diagram. Therefore, no separate traction wire and conductor wiring are required, allowing the ablation device (3400) to be reduced in size and manufactured at a lower cost.

[0201] Figure 34C and 34D This is a cross-sectional side view of a variant of the ablation device (3400). Figure 34C An ablation device (3400) including a single first catheter actuator (3430) is shown, and Figure 34D An ablation device (3400) is shown, comprising a pair of first catheter actuators (3430, 3432). Each first catheter actuator (3430, 3432) can be configured to be electrically coupled to an electrode for redundancy.

[0202] Figure 34C An ablation device (3400) is depicted, comprising a first conduit (3410) defining a first conduit lumen (3412) and a first conduit actuator lumen (3434). In some variations, the first conduit actuator (3430) may include a wire wiring (3431) including an insulator surrounding the electrode wiring. In some variations, the insulator may be configured as a slidable channel. The insulator may include, for example, PTFE, PEEK, polyimide, combinations thereof, etc. In some variations, the first conduit actuators (3430, 3432) may be coupled along the length of the first conduit (3410) to the inner wall of the first conduit (3410).

[0203] In some variations, multiple first catheter actuators can further enhance maneuverability and control over the ablation device. For example, the first catheter actuators can be actuated together to provide a push-pull action (e.g., one actuator is configured to pull while another actuator pushes). Figure 34DAn ablation device (3400) is depicted, comprising a first catheter (3410) defining a first catheter actuator lumen (3434, 3436) having corresponding first catheter actuators (3430, 3432). In some variations, the first catheter actuators (3430, 3432) may be disposed on opposite sides of the first catheter (3410). In some variations, the first catheter actuator lumen (3434, 3436) may include a "D" shape.

[0204] In some variations, the first catheter actuator may be made of stainless steel. In some variations, the first catheter (3410) may include a core (3411) (e.g., PTFE) configured to maintain the alignment and radial position of the first catheter actuator (3430, 3432).

[0205] expander

[0206] Generally, the dilator described herein can be configured to puncture tissue (such as the interatrial septum) to allow one or more portions of the ablation device to be advanced into a body cavity (such as the left atrium of the heart). In some variations, the dilator can generally be configured to dilate tissue (such as the interatrial septum). The profile of the dilator can be damage-resistant to minimize any unintentional or unintended injury. The dilator may include a taper of about 1 degree to about 45 degrees to facilitate the device's passage through the septum to the left atrium. In some variations, the dilator may include thermoplastic polymers, nylon, polyurethane, ABS, acetal, polycarbonate, PET, PEBA, PEEK, PTFE, silicone, PS, PEI, latex, sulfate, barium sulfate, copolymers, combinations thereof, etc. As described in more detail herein, the dilator may include one or more visual features, such as fluid ports and echo zones.

[0207] In some variations, the dilator of the ablation device can be configured to facilitate tissue compression and / or cutting. As described herein, the distal end of the electrode can be configured to abut against a corresponding mating surface of the dilator. For example, a second catheter can be withdrawn relative to a first catheter, causing the mating surface to apply a preload force to the electrode. Compression of the tissue between the electrode and the mating surface (via preload force) can reduce the thickness of the tissue to be cut, allowing the septum to be cut faster and with less energy. Furthermore, the compressed tissue can hold (e.g., fix, lock) the tissue in place relative to the ablation device to ensure that only a predetermined portion of the tissue is cut. In some variations, tissue compression during the application of electrical energy can fuse tissue layers (e.g., the left and right atrial septa) together during ablation, thereby reducing the surface area of ​​exposed tissue along the periphery of the anastomosis after tissue removal. Tissue compression can also reduce tissue volume.

[0208] In some variations, the expander can be configured to contact the electrode and short-circuit it when the tissue is completely cut. This stops the formation of the cutting plasma and reduces excessive energy transfer, heat, bubble formation, nerve stimulation, etc. For example, cutting plasma can be generated to remove compressed tissue between the electrode and the expander mating surface when the uninsulated distal end of the electrode is energized. However, once the tissue has been cut and separated from the electrode, the electrode can be isolated from the body's conduction pathway provided by the tissue, thereby extinguishing the cutting plasma. Therefore, tissue ablation can be performed mechanically without sensors and / or feedback control, thus reducing the complexity of the ablation procedure.

[0209] Figure 35A This is a cross-sectional side view of the distal end of an ablation device (3500) including a dilator (3510), an insulator (3520), and an electrode (3530). The dilator (3510) may include a lumen (3512), a proximal end (3514), and a mating surface (3516) defining a recess (3518) configured to receive the distal end of the electrode (3530). Figure 35A As shown, the distal end of the electrode (3530) is not insulated. In some variations, the mating surface (3518) may include one or more non-conductive and / or heat-resistant portions. In some variations, the mating surface (3518) may be configured to withstand the high temperatures generated during the ablation procedure. For example, the non-conductive portions may include one or more of polymers (e.g., PEEK, polyimide), ceramics (e.g., zirconium oxide), and alumina. Thus, when the electrode (3530) cuts tissue and engages the groove (3518) of the mating surface (3516), the electrode (3530) may be configured to short-circuit.

[0210] Additionally or alternatively, the mating surface may include a deformable material. Figure 35B This is a detailed cross-sectional side view of an ablation device (3550) including an expander (3560), an insulator (3570), and an electrode (3580). The expander (3560) may include a proximal end (3564) and a mating surface (3566). In some variations, the mating surface (3516) may be configured to be deformable (e.g., compressible). When the expander (3560) is withdrawn toward the electrode (3580), the tissue disposed between the electrode (3580) and the mating surface (3566) may be compressed along with the mating surface itself.

[0211] Additionally or alternatively, the mating surface may include conductive portions configured to focus RF energy (e.g., focus a monopole) to act as dissipative elements and / or enhance electric field lines, thereby controlling stray excitation of the tissue during cutting. For example, the conductive portion of the expander may increase the surface area electrically coupled to the electrode to reduce the current density of the electrode to below a threshold level sufficient to cut the tissue. Thus, the electrode may be configured to contact the conductive mating surface after the tissue has been cut. In some variations, the conductive portion of the mating surface may have a surface area between approximately 4 and approximately 10 times that of the exposed portion of the electrode (e.g., the distal edge of the electrode).

[0212] In some variations, the expander may include a length between approximately 2 mm and approximately 2 cm. For example, the expander may include a length between approximately 5 mm and approximately 1 cm. In some variations, the expander may include a taper between approximately 5 degrees and approximately 20 degrees relative to the longitudinal axis of the expander. In some variations, the distal end of the expander may be damage-resistant (e.g., rounded, blunt-tipped). As described herein, barbs may be coupled to the proximal end of the expander.

[0213] handle

[0214] Generally, the handle described herein can be configured to allow an operator to grasp and control the position, orientation, and operation of one or more ablation devices. In some variations, the handle may include actuators to allow translation and / or rotation of the first and second catheters, in addition to manipulation by optional delivery catheters. In some variations, deployment of the barbs may be achieved by a deployment mechanism (e.g., a screw / rotation mechanism, translation mechanism, slider). In some variations, the handle may be configured to limit the force that a user can apply to the catheter axes relative to each other for advancement and retraction. For example, the handle may be configured to apply energy to electrodes to ablate tissue and / or control one or more sensors. In some variations, the handle may be coupled between a signal generator and the ablation device.

[0215] Figure 39A This is a perspective view of the handle (3900) of the ablation device, and Figure 39B This is its plan view. In some variations, the handle (3900) may include one or more actuation mechanisms (3910), a fluid port (3920), and a detachable electrical connection (3930). The handle (3900) may be coupled to the proximal end of the first catheter (3950). In some variations, the handle (3900) may be configured to be held (e.g., gripped) by an operator and to control one or more of the following: catheter deflection (e.g., maneuverability), tissue ablation (e.g., electrode energy delivery), catheter translation (e.g., switching between open and closed configurations, tissue compression), and visualization (e.g., contrast fluid delivery).

[0216] For example, the actuation mechanism (3910) can be configured to control the preload force of the dilator of the second catheter applied by the electrode against the first catheter, as described in detail herein. In some variations, the actuation mechanism (3910) may include a helical mechanism with a plurality of predetermined stops that allow the operator to select the preload amount at the distal end of the ablation device. For example, when the ablation device is in a cutting configuration where tissue is compressed between the electrode and the dilator, the operator can use the actuation mechanism (3910) to select a predetermined preload force. In some variations, the actuation mechanism (3910) may be coupled to the axis of the second catheter such that the actuation mechanism (3910) can be configured to use the helical mechanism to pull the distal portion of the second catheter toward the handle (3900).

[0217] In some variations, the actuation mechanism (3910) may be configured to actuate one or more first catheter actuators as described herein. For example, the first catheter actuator may be configured to manipulate and / or deflect the distal portion of the first catheter. That is, the actuation mechanism (3910) may be configured to push and / or pull the first catheter.

[0218] signal generator

[0219] Generally, the signal generator described herein can be configured to supply energy (e.g., an energy waveform) to an ablation device to ablate a predetermined portion of tissue (such as an atrial septum). In some variations, the ablation system described herein may include a signal generator having an energy source and a processor configured to deliver waveforms to deliver energy to the tissue (e.g., the atrial septum). The waveforms disclosed herein can facilitate anastomosis. In some variations, the signal generator can be configured to control waveform generation and delivery in response to received sensor data. For example, energy delivery may be suppressed unless pressure sensor measurements confirm tissue engagement and compression between the electrode and the corresponding mating surface.

[0220] Signal generators can generate and deliver several types of signals, including but not limited to radio frequency (RF), direct current (DC) pulses, stimulation range pulses, and / or mixed electrical pulses. For example, a signal generator can generate monophase (DC) pulses and biphase (DC and AC) pulses. A signal generator may include a processor, memory, a power source, and a user interface. The processor can incorporate data received from one or more of the memory, power source, user interface, and ablation device. The memory can also store instructions to cause the processor to execute modules, processes, and / or functions associated with the system, such as waveform generation and delivery. For example, the memory can be configured to store patient data, clinical data, surgical data, etc.

[0221] In some variations, the signal generator can be configured to generate alternating current, voltage, and / or power in the radio frequency spectrum between approximately 9 kHz and approximately 300 MHz at power levels between approximately 5 W and approximately 500 W. In some variations, the RF generator operates by outputting a constant voltage, constant power, and / or constant current. In some variations, the RF generator outputs a constant sine wave throughout the entire tissue cutting process. For example, the RF generator can be configured to output a sine wave between approximately 400 kHz and approximately 600 kHz, between approximately 450 kHz and approximately 550 kHz, and between approximately 475 kHz and approximately 525 kHz (inclusive of all values ​​and subranges therebetween). In some variations, the RF signal output is interrupted and attenuated, such that RF energy is applied for a fixed percentage of the operating time.

[0222] In some variations, the signal generator can be configured to synchronize energy delivery with a predetermined phase of the patient's cardiac cycle. For example, a sensor can be configured to measure an ECG signal, and the signal generator can be configured to deliver a signal waveform based on the ECG signal (e.g., synchronously with the ECG signal). Additionally or alternatively, a pacing signal for cardiac stimulation can be generated by the signal generator synchronously with the pacing signal and used to deliver the signal waveform.

[0223] Figure 37 The voltage waveform (3700) is an exemplary variant of the ablation procedure, comprising a first waveform (e.g., an overshoot spike) (3710) and a second waveform (e.g., a substantially steady-state voltage) (3720). In some variants, a signal generator may be configured to generate the first waveform (3710), followed by the second waveform (3720), wherein the first waveform includes a first voltage higher than the second voltage of the second waveform. The first waveform (3710) may be configured to rapidly cut tissue during energy delivery. The second waveform (3720), having a lower voltage, may reduce one or more of thermal diffusion, blistering, nerve stimulation, etc. The second waveform may be configured to dry the cut tissue held within the ablation device, thereby aiding in tissue retention and separation.

[0224] Alternatively, the first waveform can be configured to dry the tissue. For example, the first waveform may include a voltage below the vapor ionization threshold (e.g., below about 130 volts) for a duration between about 100 milliseconds and about 60 seconds. Impedance can be monitored to prevent plasma formation.

[0225] Generally, the processor described herein (e.g., CPU) can process data and / or other signals to control one or more components of the system. The processor can be configured to receive, process, compile, compute, store, access, read, write, and / or transmit data and / or other signals. In some variations, the processor can be configured to access or receive data and / or other signals from one or more sensors (e.g., pressure sensors) and storage media (e.g., memory, flash drives, memory cards). In some variations, the processor can be any suitable processing device configured to run and / or execute a set of instructions or code, and can include one or more data processors, image processors, graphics processing units (GPUs), physical processing units, digital signal processors (DSPs), analog signal processors, mixed signal processors, machine learning processors, deep learning processors, finite state machines (FSMs), compression processors (e.g., data compression to reduce data rate and / or memory requirements), encryption processors (e.g., for secure wireless data and / or power transmission), and / or central processing units (CPUs). The processor can be, for example, a general-purpose processor, a field-programmable gate array (FPGA), an application-specific integrated circuit (ASIC), a processor board, etc. The processor can be configured to run and / or execute application processes and / or other modules, processes, and / or functions associated with the system. The underlying device technologies can be provided in various component types (e.g., metal-oxide-semiconductor field-effect transistor (MOSFET) technology similar to complementary metal-oxide-semiconductor (CMOS), bipolar technology similar to emitter-coupled logic (ECL), polymer technologies (e.g., silicon conjugated polymers and metal conjugated polymer-metal structures), analog and digital mixed-signal technologies, etc.).

[0226] The systems, apparatuses, and / or methods described herein can be implemented by software, hardware, or a combination thereof (executing on hardware). Hardware modules can include, for example, general-purpose processors (or microprocessors or microcontrollers), field-programmable gate arrays (FPGAs), and / or application-specific integrated circuits (ASICs). Software modules (executing on hardware) can be implemented in various software languages ​​(e.g., computer code) (including C, C++, etc.). Python, Ruby, Visual Computer code is expressed using object-oriented, procedural, or other programming languages ​​and development tools. Instances of computer code include, but are not limited to, microcode or microinstructions, machine instructions (such as those generated by a compiler), code for generating network services, and files containing high-level instructions that are executed by a computer using an interpreter. Additional instances of computer code include, but are not limited to, control signals, encryption code, and compression code.

[0227] Generally, the ablation device described herein may include a memory configured to store data and / or information. In some variations, the memory may include one or more of random access memory (RAM), static RAM (SRAM), dynamic RAM (DRAM), memory buffers, erasable programmable read-only memory (EPROM), electrically erasable read-only memory (EEPROM), read-only memory (ROM), flash memory, volatile memory, non-volatile memory, combinations thereof, etc. In some variations, the memory may store instructions to cause a processor to perform modules, processes, and / or functions associated with the ablation device, such as signal waveform generation, ablation device control, data and / or signal transmission, data and / or signal reception, and / or communication. Some variations described herein relate to computer storage products having non-transitory computer-readable media (also referred to as non-transitory processor-readable media) having instructions or computer code thereon for performing various computer-implemented operations. Computer-readable media (or processor-readable media) are non-transitory in the sense that they do not contain transiently propagating signals (e.g., propagating electromagnetic waves carrying information on a transmission medium such as space or cable). Media and computer code (also called code or algorithms) can be those designed and constructed for a specific purpose.

[0228] In some variations, the ablation device may also include a communication device configured to allow an operator to control one or more of the devices within the ablation system. The communication device may include a network interface configured to connect the ablation device to another system (e.g., the Internet, a remote server, a database) via a wired or wireless connection. In some variations, the ablation device may communicate with other devices (e.g., mobile phones, tablets, computers, smartwatches, etc.) via one or more wired and / or wireless networks. In some variations, the network interface may include one or more of a radio frequency receiver / transmitter, an optical (e.g., infrared) receiver / transmitter, etc., configured to communicate with one or more devices and / or networks. The network interface may communicate with one or more of the ablation device, network, database, and server via wired and / or wireless means.

[0229] A network interface may include RF circuitry configured to receive and / or transmit RF signals. The RF circuitry can convert electrical signals into electromagnetic signals or vice versa, and communicate with communication networks and other communication devices via electromagnetic signals. The RF circuitry may include known circuitry for performing these functions, including but not limited to antenna systems, RF transceivers, one or more amplifiers, tuners, one or more oscillators, mixers, digital signal processors, codec chipsets, Subscriber Identity Module (SIM) cards, memory, and so on.

[0230] Wireless communication over any device can use any of a variety of communication standards, protocols, and technologies, including but not limited to Global System for Mobile Communications (GSM), Enhanced Data GSM Environment (EDGE), High-Speed ​​Downlink Packet Access (HSDPA), High-Speed ​​Uplink Packet Access (HSUPA), Evolution, Data-Only (EV-DO), HSPA, HSPA+, Dual-Cell HSPA (DC-HSPDA), Long Term Evolution (LTE), Near Field Communication (NFC), Wideband Code Division Multiple Access (W-CDMA), Code Division Multiple Access (CDMA), Time Division Multiple Access (TDMA), Bluetooth, and Wi-Fi (e.g., IEEE 802.11a, IEEE 802.11b, IEEE 802.11g, IEEE...). This includes protocols such as 802.11n, Voice over Internet Protocol (VoIP), Wi-MAX, protocols for email (e.g., Internet Messaging Access Protocol (IMAP) and / or Post Office Protocol (POP)), instant messaging (e.g., Extensible Messaging and Presence Protocol (XMPP), Session Initiation Protocol for Instant Messaging and Presence Utilizing Extended Protocol (SIMPLE), Instant Messaging and Presence Service (IMPS)) and / or Short Message Service (SMS), or any other suitable communication protocol. In some variations, the devices described herein can communicate directly with each other without transmitting data over a network (e.g., via NFC, Bluetooth, WiFi, RFID, etc.).

[0231] In some variations, the user interface may include an input device (e.g., a touchscreen) and an output device (e.g., a display device), and may be configured to receive input data from one or more of the ablation device, a network, a database, and a server. For example, operator control of the input device (e.g., a keyboard, buttons, a touchscreen) may be received by the user interface and then processed by a processor and the user interface's memory to output control signals to the ablation device. Some variations of the input device may include at least one switch configured to generate control signals. For example, the input device may include a touch surface for the operator to provide input corresponding to the control signals (e.g., finger contact with the touch surface). Input devices including touch surfaces may be configured to detect contact and movement on the touch surface using any of a variety of touch sensitivity technologies, including capacitance, resistance, infrared, optical imaging, scattered signals, acoustic impulse recognition, and surface acoustic wave technologies. In variations of the input device that include at least one switch, the switch may include at least one of, for example, a button (e.g., a hard key, a soft key), a touch surface, a keyboard, an analog stick (e.g., a joystick), a direction pad, a mouse, a trackball, a dial, a step switch, a rocker switch, a pointer device (e.g., a stylus), a motion sensor, an image sensor, and a microphone. The motion sensor may receive operator motion data from optical sensors and classify the operator's posture as a control signal. The microphone may receive audio data and identify the operator's voice as a control signal.

[0232] Tactile devices can be integrated into one or more input and output devices to provide additional sensory outputs (e.g., force feedback) to an operator. For example, a tactile device can generate a tactile response (e.g., vibration) to confirm the operator's input to an input device (e.g., a touch surface). As another example, tactile feedback can notify the operator that their input has been covered by an ablation device.

[0233] II. Methods

[0234] Methods for forming anastomoses in a patient's atrial septum using the systems and devices described herein are also described herein. Specifically, the systems, devices, and methods described herein can be used to capture, ablate, and remove predetermined portions of tissue to form an anastomosis for the treatment of heart failure. In some variations, the method of forming an anastomosis may involve advancing the device into the patient's right atrium. A guidewire may pass through the atrial septum of the heart and into the left atrium. The device may include a dilator configured to puncture the septum such that a first catheter is positioned within the right atrium and a second catheter within the left atrium. The second catheter may include barbs configured to engage and secure tissue when withdrawn relative to the first catheter. As the barbs are further withdrawn (e.g., toward the right atrium), the engaged tissue may stretch and / or compress against the barbs due to the elasticity of the tissue, forming a "tent" shape. The barbs and the engaged, open tissue may be withdrawn into the lumen of an electrode (e.g., a tubular electrode). By positioning the ablation device on either side of the interatrial septum, a predetermined force can be applied to engage and / or compress a predetermined portion of the septal tissue to be ablated. For example, an electrode of the first catheter can be abutted against the proximal end of a dilator (e.g., a mating surface) to compress the septal tissue. An electrode positioned in the right atrium can be excited to cut (e.g., remove) tissue using an ablation waveform and RF energy, as described in more detail herein. The removed tissue can be sealed by the ablation device to prevent tissue loss. For example, the removed tissue can be held by barbs, and the electrode can be positioned around the removed tissue and the barbs. Thus, the ablation device described herein can be configured to safely and efficiently form an atrial anastomosis.

[0235] Figure 18 This is a flowchart generally describing a variation of the method (1800) for forming an anastomosis. The method (1800) may include advancing an ablation device comprising a first catheter and a second catheter into the patient's right atrium (1802). For example, the ablation device may be advanced over a guidewire and inserted via the femoral vein using, for example, a transseptal puncture method. In some variations, the ablation device within the right atrium may be oriented substantially perpendicular to the interatrial septum. For example, the first catheter actuator described herein may be configured to deflect a distal portion of the ablation device to reposition the ablation device relative to the interatrial septum. Upon advancement into the heart, the first catheter may be adjacent to the second catheter. For example, a delivery catheter may be configured to hold each of the first and second catheters until deployment within the heart.

[0236] Throughout the ablation procedure, the ablation device catheter can be indirectly visualized as needed. Indirect visualization, such as echocardiography and / or fluoroscopy, can help the operator position and / or align the ablation device relative to the tissue. For example, under ultrasound imaging, the ablation device can be used to introduce contrast agents, such as microbubbles, into the endocardial space to position electrodes and / or dilators relative to the atrial septum positioned therein. The user can then bring the catheter very close to compress and cut the tissue. In some variations, the ablation device can be configured to output microbubbles in a closed configuration for ultrasound visualization of the ablation device and the atrial septum.

[0237] In some variations, contrast agents can be introduced into the heart via a fluid port in the dilator. In some of these variations, contrast agents can be introduced into the lumen of the electrode. Additionally or alternatively, the distal end of the ablation device may include an echo zone capable of receiving ultrasound. For example, the distal end of the ablation device may include one or more microspheres with a diameter between about 5 μm and about 100 μm.

[0238] Figure 32 This is a side view of an ablation device (3200) in the endocardial space. In some variations, the ablation device (3200) may include a first catheter (3210), an electrode (3220), a second catheter (3230), a barb (3240), and a dilator (3250). The illustrated ablation device (3200) is in an open configuration, with tissue (e.g., an atrial septum) (3280) disposed between the electrode (3220) and the dilator (3250), spaced apart from the barb (3240). In some variations, the first catheter (3120) may be configured to deliver contrast reagent (e.g., microbubbles) (3270) into the lumen of the electrode (3220) and the endocardial space. For example, the contrast reagent lumen (3212) of the first catheter (3210) may be configured to deliver contrast reagent (3270) into the lumen of the electrode (3220). Contact between the contrast agent (3270) and the electrode (3220) and tissue (3280) enables indirect visualization of one or more steps of the ablation procedure (e.g., echocardiography). Visualization of the ablation device (3200) and tissue (3280) can aid in the positioning of the electrode relative to the tissue (3280). For example, the contrast agent (3270) can be introduced into the right atrium prior to using barbed attachment of the tissue (3280). The contrast agent (3270) flowing through the lumen of the electrode (3220) and the endocardial space allows visualization of the electrode (3220) and the right atrial side of the interatrial septum.

[0239] The second catheter can be advanced through the interatrial septum into the left atrium (1804). For example, the dilator of the second catheter can be advanced through the interatrial septum (e.g., via a guidewire), so that the guidewire and dilator are located in the left atrium. The second catheter can be translated relative to the first catheter. The barbs of the second catheter can be advanced into the left atrium, so that the electrodes of the first device can be located in the right atrium. When it is advanced into the left atrium, diaphragmatic tissue may slip over the barbs. Figure 19A and 19B As shown, the ablation device (1900) can be placed in the right atrium (1990) and advanced into the left atrium (1980) using the dilator of the second catheter (1950). The second catheter (1950) can be translated relative to the first catheter (1910) in the right atrium (1990) and the interatrial septum (1970). The barbs (1940) of the second catheter (1950) can be advanced through the septum (1970) and into the left atrium (1980). Figure 19C As shown in the cross-sectional side view, the first conduit (1910) may include a tubular electrode (1920), a lumen (1922), a wire (1924), a connector (1926), and an insulator (1960). The second conduit (1950) may include a barb (1940), a mating surface (1954), an expander, and an expander lumen (1952).

[0240] In some variations, the ablation device can introduce contrast agents (e.g., microbubbles) to visualize the interface between the dilator, tissue, and electrodes. In some variations, based on visualization, the electrodes can be repositioned between approximately 2 mm and approximately 5 mm from the interatrial septum.

[0241] The second catheter can be withdrawn relative to the first catheter (1806). For example, the second catheter can be translated toward the first catheter to bring the electrodes and dilator closer together. In some variations, the second catheter can be withdrawn while the first catheter remains in a substantially fixed position in the right atrium. In some variations, contrast agents (e.g., microbubbles) can be introduced to confirm the position of barbs, tissue, and electrodes.

[0242] In some variations, withdrawing the second catheter toward the first catheter may include translating the barbs relative to the dilator to engage the first portion of the septum. For example, as... Figure 30A and 30B As shown, the barbs can be removed from the dilator. Specifically, the first conduit (3030) can be changed from a first configuration in which the barbs (3020) are arranged within the groove (3040) of the dilator (3030) to a second configuration in which the barbs (3020) are arranged outside the groove (3040).

[0243] As the second catheter is withdrawn, its barbs can engage a predetermined portion of the septum (1808). In some variations, such as Figures 29A to 29C As shown, a barb may be included that rotates about the longitudinal axis of the barb. The size of the first tissue portion cut from the second tissue portion may correspond to the rotation angle of the barb. The barb may rotate at a rotation angle of up to approximately 360 degrees.

[0244] like Figure 19D As shown, when the second catheter (1950) is withdrawn relative to the first catheter (1910), the barb (1940) can engage the septal tissue (1970). For example, when the second catheter is withdrawn toward the first catheter, the barb can pierce the first portion. The barb can pierce the first portion such that the layers of the atrial septum (e.g., the left and right atrial layers) remain together to reduce tissue separation and / or tissue shearing. Thus, the barb (1940) can capture (e.g., fix, retain) the tissue (1970) while maintaining the structural integrity of the septum. In some variations, the withdrawn barb can apply a force to the septum to hold and stretch a portion of the septum (e.g., the first portion) over the barb. This force can be increased as the second catheter is further withdrawn toward the first catheter. In some variations, withdrawing the second catheter can apply a force of at least 20 grams to the atrial septum. For example, an ablation device can apply a force of about 20 grams to about 30 grams to the atrial septum. In some variations, when withdrawn into the lumen, the first portion of the diaphragm can form a generally cylindrical shape.

[0245] The barbs described herein have a structure designed to engage a first portion of the septum without shearing tissue (e.g., damaging or tearing one or more interatrial septa), such that the first portion remains intact when engaged with the barbs and withdrawn into the lumen of the electrode. That is, even when the barbs pierce the septum, the force applied by the barbs described herein allows the structural integrity of the first portion to be maintained. This ensures that the first portion of the septum to be removed remains held and secured by the barbs throughout the procedure, thereby improving the consistency and safety of the method described herein.

[0246] The septum can be withdrawn back into the lumen of the electrode (1810). In some variations, a portion of the atrial septum can form a tent over the barbs when the septum is withdrawn back into the lumen of the electrode. In this way, the tissue to be cut can be held within the ablation device before resection, reducing the risk of uncontrolled tissue loss in the ventricles and vascular system. Figure 19EAs shown, a portion of the septum (1970) can be formed into a tent-like shape over the barbs (1940). In some variations, the barbs (1940) engaged with the tissue can rotate as they are withdrawn into the lumen of the electrode to apply a rotational force to the stretched (e.g., opened) septum tissue. In some variations, the size (e.g., diameter) of the tissue to be cut (1970) can be controlled by varying the distance the engaged tissue (1970) is withdrawn into the lumen (1922). Thus, the size of the anastomosis can be independent of the diameter of the electrode. By withdrawing the second catheter toward the first catheter, the ablation device (1900) engages, stretches, compresses, locks, and expands the tissue, and controls the size of the opening to be cut. In some variations, the size of the anastomosis can depend on the distance the barbs are withdrawn into the electrode, such that the size of the anastomosis can be independent of the diameter of the ablation device.

[0247] In some variations, contrast agents (e.g., microbubbles) can be introduced to confirm the location of barbs, tissue, and electrodes (e.g., to confirm that the electrodes are in the right atrium).

[0248] The diaphragm can be compressed between the electrode and the expander (1812). For example... Figure 19E As shown, a portion of the interatrial septum (1970) can be held between the electrode (1920) and the dilator (1950). For example, the electrode and dilator can be combined to adjoin (e.g., compress) opposite sides of the interatrial septum (1970), thereby “locking” the tissue (1970) in place relative to the ablation device (1900). In some variations, the force applied to the interatrial septum by compression by the barb (1940) can be applied before and during the delivery of the ablation waveform. The compressed tissue can reduce the applied RF energy required to cut the tissue. In some variations, one or more of the barb and dilator can be rotated about the longitudinal axis of the second catheter to further engage and / or compress the tissue.

[0249] In some variations, such as Figure 35B As shown, withdrawing the second catheter toward the first catheter deforms the compressible proximal portion of the dilator.

[0250] Figure 36AThis is a side view of an ablation device (3600) in the endocardial space, illustrating the compression steps of the ablation procedure. In some variations, the ablation device (3600) may include a first catheter (3610), an electrode (3620), a second catheter (3630), a barb (3640), and a dilator (3650). In some variations, the first catheter (3610) may include a contrast agent lumen (3612), as described in more detail herein. In some variations, the electrode (3620) may include lumens configured to hold one or more of the barb (3640), a first portion (3672) of tissue, and a proximal portion (3652) of the dilator (3650). In some variations, a guidewire (3630) may be slidably disposed within the second catheter (3630).

[0251] like Figure 36A As shown, the barb (3640) can be configured to engage a first portion (3672) of the interatrial septum (3670) in a cutting configuration where tissue (3674) is compressed between the distal edge of the electrode (3630) and the proximal portion (3652) of the dilator (3650). For example, the distal end of the electrode (3620) can be configured to abut against a corresponding mating surface (3652) of the dilator (3650). For example, the second catheter (3630) can be withdrawn relative to the first catheter (3610) such that the mating surface (3652) applies a preload force to the tissue (3674) and the electrode (3620). In some variations, the application of the preload force can be controlled by an operator via an actuator of the handle. The compression of the tissue between the electrode and the mating surface (via the preload force) can reduce the thickness of the tissue to be cut, allowing the septum to be cut faster and with less energy. Furthermore, the compressed tissue can be held (e.g., fixed, locked) in place relative to the ablation device to ensure that only a predetermined portion of the tissue is cut. Tissue compression can also reduce tissue volume. In some variations, the preload force can be between about 0.4 N and about 25 N, about 1 N and about 10 N, about 5 N and about 10 N, about 5 N and about 15 N, and about 10 N and about 20 N, including all ranges and sub-values ​​therein.

[0252] In some variations, the compressed tissue (3674) and the expander (3650) can be stationary in a static equilibrium state, wherein the proximal portion (3652) of the expander (3650) compresses the tissue (3674) against the electrode (3620) using a shear force including a radial component. In some variations, the extension of the expander (3650) before cutting is beneficial to the operator when observed under a fluorescence microscope. In some variations, in the cutting configuration ( Figure 36A The ablation device (3600) in the ablation device (3650) can correspond to the expander (3650), which extends about 1 mm from the end of the electrode (3620).

[0253] An ablation waveform can be delivered to the electrodes to cut the septum (1814). For example, a signal generator can generate a biphasic radio frequency waveform configured to ablate a portion of the atrial septum held by the device. In some variations, the electrodes can be configured to deliver a current of 50 mA to 4 A at a rate of up to about 500 kHz, ranging from about 0.1 kV to about 4.0 kV.

[0254] In some variations, the delivery of the ablation waveform can be controlled based on the distance between the electrode and the expander. For example, the electrode can be configured to short-circuit when it contacts the mating surface of the expander during the delivery of the ablation waveform.

[0255] In some variations, the ablation waveform may include a first waveform followed by a second waveform. The first waveform may include a first voltage, and the second waveform may include a second voltage. The first voltage may be higher than the second voltage.

[0256] Figure 19F An ablation device (1900) is shown, which defines a compartmental space (1970) with a predetermined opening and barbs (1940) within a lumen (1922) of electrodes (1920) to hold the excised tissue. (See also:) Figure 19F As shown, the diaphragm (1970) can be rapidly restored after the tissue joined by the barbs (1940) is removed. Once ablation is complete and the electrodes contact the dilator (1950), the tissue within the lumen (1922) can be sealed within the ablation device (1900). In this way, the removal of tissue can be prevented from being lost in the body.

[0257] Figure 36B An ablation device (3600) in a closed (e.g., positioned) configuration is depicted, wherein the cut tissue (e.g., a first portion) (3672) engages with a barb (3640) and is held within the lumen of an electrode (3620). The proximal portion (3652) of a dilator (3650) may, for example, be positioned within the lumen of the electrode (3620). Figure 36B The pores (3676) formed in the interatrial septum (3670) are depicted.

[0258] In some variations, visualization can confirm the completion of the energy delivery process. For example, the ablation device (3600) in the cutting configuration ( Figure 36A ) and closed configuration ( Figure 36B Differences between the two can be confirmed through indirect visualization. For example, based on the imaging position of the expander (3650) relative to the electrode (3620), fluorescence microscopy visualization can confirm when tissue is between the electrode (3620) and the expander (3650), and when tissue is cut after energy delivery.

[0259] In some variations, during and / or after energy delivery, a preload force (e.g., a first predetermined force) may be applied to the electrode (3620) by the expander (3650) to ensure the retraction of the second catheter (3630) toward the first catheter (3610). In some variations, the operator may activate a switch in the handle to initiate energy delivery for tissue cutting. As the proximal portion (3652) is retracted toward the electrode (3620) and compressed during energy delivery, the proximal portion (3652) may shear (e.g., cut, separate) tissue from the septum (3670) with a second predetermined force greater than the first predetermined force. That is, the proximal portion (3652) may be used as a cutting plate to ensure the cutting of even small tissue fibers (3674) (e.g., a second portion) from the septum (3670). Alternatively, when delivering the ablation waveform to the electrode (3620), the preload force may not be applied to the tissue (3674) and the electrode (3620). During energy delivery, the expander (3650) can naturally retract into the lumen of the electrode (3620) after the tissue (3674) has been cut (e.g., ablated).

[0260] In some variations, when the mating surface (e.g., the proximal portion (3652)) engages the electrode, such as Figure 36B The proximal portion (3652) of the dilator (3650) shown can be disposed within the lumen of the electrode (3620). The proximal portion (3652) disposed within the lumen of the electrode (3620) can securely and coaxially attach the electrode to the dilator. For example, the dilator can be fixed to a first catheter (3610) to withstand movement under lateral loads, such as when the ablation device is being tracked over a curved guidewire. Furthermore, the electrode (3620) securely coupled to the dilator (3650) can be configured to prevent the ablation device (3600) from seizing (e.g., hooking) blood vessels, tissues (e.g., via septal crossing), guides, sheaths, etc., during advancement and withdrawal through body cavities. In some variations, when mating with a surface-mount electrode (3620), approximately 0.5 mm to approximately 2 mm of the proximal portion (3652) of the dilator (3650) can be disposed within the lumen of the electrode (3620). In some variations, Figure 36B The ablation device (3600) shown can be removed from the patient's body.

[0261] The first and second catheters can be withdrawn from the patient (1816). This may involve withdrawing the resected tissue retained within the first catheter while the first and second catheters are withdrawn together. In some variations, the procedure may be performed with ultrasound and / or fluorescence imaging in one or more steps.

[0262] Example

[0263] Figure 20 and21 This is a perspective view of a variation of the ablation device (2000, 2100). In some variations, the ablation device (2000, 2100) may include a first catheter (2010, 2110) and a second catheter (2030, 2130). The first catheter (2010, 2110) may include a tubular electrode (2020, 2120). The electrode (2020, 2120) may define a lumen (2022, 2122) configured to hold barbs (2040, 2140) of the second catheter (2030, 2130). The tubular electrode (2020, 2120) may include a cylindrical shape. In some variations, the ablation device (2000, 2100) may include a second catheter (2030, 2130) slidably disposed within the first catheter (2010, 2110). The second catheter (2030, 2130) may include barbs (2040, 2140) and dilators (2050, 2150) configured to engage electrodes (2020, 2120). In some variations, the barbs (2040, 2140) may include a plurality of protrusions generally inclined toward the electrodes (2020, 2120). The dilators (2050, 2150) may include a tapered shape. Figure 22 This is a perspective view of the ablation device (2200) attached to the excised tissue (2260). In some variations, the ablation device (2200) may include a first catheter (2210) and a second catheter (2230). The excised tissue (2260) is fitted within the lumen (2222) of the electrode (2220) for removal from the patient.

[0264] Figure 23 The image shows a fluorescence microscope view (2300) of the ablation device (2310, 2320) in open and closed configurations, respectively. One or more portions of the ablation device (2310, 2320) may include radiopaque portions.

[0265] Figure 24 Image (2400) of anastomosis (2420) formed in cadaver tissue (2410) using the ablation system and method described herein. Figure 25A and 25B Image (2500) of anastomosis (2520) formed in porcine tissue (2510) using the ablation system and method described herein.

[0266] Figure 27A and 27BThis is a perspective view of a variant of an ablation device (2700) attached to tissue (2760). In some variants, the ablation device (2700) may include a first catheter (2710) and a second catheter (2730). The first catheter (2710) may include a tubular electrode (2720). The electrode (2720) may define a lumen (2722) configured to hold a barb (2740) of the second catheter (2730). The tubular electrode (2720) may include a cylindrical shape. In some variants, the ablation device (2700) may include a second catheter (2730) slidably disposed within the first catheter (2710). The second catheter (2730) may include a similar Figure 26A and 26B The variations shown include a barb (2740) and a dilator (2750) configured to engage an electrode (2720). In some variations, the barb (2740) may include multiple protrusions, including tissue-engaging portions substantially parallel to the longitudinal axis of the second catheter (2730). The dilator (2750) may include a tapered conical shape.

[0267] The organization (2760) can be configured to engage with the barb (2740), as described in more detail herein. Although in Figure 27A and 27B A second catheter (2730) is advanced relative to the first catheter (2710) to expose the barbs (2740) and the excised tissue (2760), but the excised tissue (2260) is fitted within the lumen (2722) of the electrode (2720) to facilitate removal of the tissue from the patient. In some variations, the lumen (2722) may have a length of at least 1 mm. For example, the lumen (2722) may have a length between approximately 5 mm and approximately 4 cm. Figure 27C Image (2770) of anastomosis (2790) formed in tissue (2780) using the ablation system and method described herein.

[0268] Figure 28A and 28B This is a perspective view of a variant of the ablation device (2800) attached to tissue (2860). In some variants, the ablation device (2800) may include a first catheter (not shown) and a second catheter (2830). In some variants, the ablation device (2800) may include a second catheter (2830) slidably disposed within the first catheter. The second catheter (2830) may include a similar... Figure 26A and 26BThe variations of the barb (2840) and dilator (2850) are shown. In some variations, the barb (2840) may include multiple protrusions, said multiple protrusions including tissue engagement portions substantially parallel to the longitudinal axis of the second catheter (2830). Tissue (2860) may be configured to engage with the barb (2840), as described in more detail herein.

[0269] As used herein, the terms “about” and / or “approximately”, when used in conjunction with numerical values ​​and / or ranges, generally refer to those numerical values ​​and / or ranges that are close to said numerical value and / or range. In some cases, the terms “about” and “approximately” may mean within ±10% of said value. For example, in some cases, “about 100 [units]” may mean within ±10% of 100 (e.g., from 90 to 110). The terms “about” and “approximately” are used interchangeably.

[0270] The specific examples and descriptions herein are exemplary in nature, and variations can be developed by those skilled in the art based on the material taught herein without departing from the scope of the invention, which is limited only by the appended claims.

[0271] Although the foregoing embodiments have been described in detail with reference to illustrations and examples for clarity and understanding, it will be apparent that certain variations and modifications may be made, and such variations and modifications are intended to fall within the scope of the appended claims. Furthermore, it should be understood that the components and features of the elements described herein can be used in any combination, and the methods described herein may include all or part of the elements described herein. The description of certain elements or features with respect to particular figures is not intended to be limiting, nor should it be construed as implying that an element cannot be used in combination with any other described elements.

[0272] Furthermore, if two or more such features, structures, systems, articles, materials, kits, steps, and / or methods disclosed herein are not inconsistent with each other, then any combination of such features, structures, systems, articles, materials, kits, steps, and / or methods is included within the scope of this invention. Additionally, some variations disclosed herein may differ from the prior art because they specifically lack one or more features, elements, and functions found in the references or combinations of references (i.e., claims for these variations may contain negative limitations).

[0273] Any and all references to publications or other documents (including but not limited to patents, patent applications, articles, web pages, books, etc.) appearing anywhere in this application are hereby incorporated herein by reference in their entirety. Furthermore, all definitions defined herein and used herein shall be understood to take precedence over dictionary definitions, definitions in referenced documents, and / or the ordinary meaning of the defined terms.

Claims

1. A system for forming an anastomosis in a heart, comprising: a first catheter (240) including an electrode (242); and a second catheter (250) slidably disposed within the first catheter (240), the second catheter (250) including a barb (260) and a dilator including a mating surface configured to engage the electrode (242).

2. The system of claim 1, wherein the barb is disposed within a lumen of the electrode when the mating surface engages the electrode.

3. The system of claim 1, wherein an outer diameter of the dilator is less than an outer diameter of the electrode.

4. The system of claim 1, wherein the second catheter defines a longitudinal axis, wherein the barb includes at least one projection including a first portion and a second portion, the first portion being angled relative to the second portion.

5. The system of claim 4, wherein a ratio of a length of the first portion to a length of the second portion is between about 2:3 and about 1:

5.

6. The system of claim 4, wherein the second portion includes a length between about 0.1 mm and about 2 cm.

7. The system of claim 1, wherein a length of the barb is between about 0.1 mm and about 5 cm.

8. The system of claim 1, wherein the electrode and the mating surface are configured to compress tissue therebetween at a first predetermined force.

9. The system of claim 1, wherein the second catheter defines a longitudinal axis, and the mating surface is neither perpendicular nor parallel to the longitudinal axis.

10. The system of claim 1, wherein a proximal end portion of the dilator is disposed within a lumen of the electrode when the mating surface engages the electrode.

11. The system of claim 1, further comprising a signal generator configured to generate a first waveform followed by a second waveform, the signal generator being coupled to the electrode, the first waveform including a first voltage and the second waveform including a second voltage, and the first voltage being higher than the second voltage.

12. The system of claim 1, wherein a proximal end portion of the dilator includes a first step portion including a first diameter and a second step portion including a second diameter greater than the first diameter, the first step portion being proximal to the second step portion.

13. The system of claim 8, wherein the dilator is configured to shear the tissue at a second predetermined force greater than the first predetermined force.

14. The system of claim 1, wherein the barb includes a projection coupled to a base, wherein the base couples the projection to the second catheter, and the base spaces the projection proximally from the dilator.

15. The system of claim 14, wherein a maximum outer diameter of the barb is less than a maximum outer diameter of the dilator, and a maximum outer diameter of the base is less than the maximum outer diameter of the barb. ​

Images