Expandable element for a shunt catheter

Abstract

At least some embodiments of the present disclosure relate to systems and methods for creating a shunt in a patient. In some embodiments, a shunt catheter includes a catheter shaft having a distal end and a proximal end, the catheter shaft including a shaft lumen; a balloon shaft disposed in the shaft lumen in a first state and extending from the catheter shaft in a second state; a balloon element disposed on the balloon shaft and inflatable in the second state; and at least one of one or more electrodes disposed on the balloon element.

Description

[0001] Cross-reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 449,878, filed March 3, 2023, and to U.S. Provisional Application No. 65 / 558,028, filed February 26, 2024, both of which are incorporated herein by reference for all purposes. Technical Field

[0003] Specific embodiments of this disclosure relate to medical systems, devices, and methods for creating shunts within a patient. More specifically, some embodiments of this disclosure relate to medical systems, devices, and methods for creating shunts on the walls of the cardiovascular system within a patient. Background Technology

[0004] Heart failure is a serious condition that occurs when the heart is unable to pump enough blood and oxygen to support the other organs in the body. Based on left ventricular (LV) function, heart failure is classified as "heart failure with reduced ejection fraction (EF)" (HFrEF; EF < 40%), "intermediate EF" (HFmrEF; EF 40–49%), or "preserved EF" (HFpEF; EF ≥ 50%). Approximately half of all heart failure patients have HFpEF. HFpEF typically occurs during exercise when there is a significant increase in LV and left atrial filling pressure, with the associated increase in lung pressure leading to pulmonary congestion. Structural interventions that reduce the elevated left atrial or right atrial filling pressure are gaining attention.

[0005] Studies in heart failure have shown that lowering left atrial pressure can reduce cardiovascular events while improving functional capacity. The creation of atrial shunts has become a therapy for decompressing the left atrium in patients with acute and chronic left HF. Therefore, attention has turned to the development of atrial shunt devices (IASDs) as a means of reducing the harmful increase in left-sided filling pressure with exercise in an effort to improve symptoms. IASDs can be used to treat various types of heart failure and / or other conditions that may cause excessive pressure in the right atrium of a patient. Summary of the Invention

[0006] Current intra-atrial septal defects (IASDs) exist within the atrial septum, posing a risk of right-to-left shunts and systemic embolism. Furthermore, with the increasing number of left-sided transseptal catheter interventions, preserving the atrial septum is crucial. Improvements in IASD techniques are needed to achieve safer and better surgical procedures.

[0007] According to some embodiments, the shunt catheter includes a catheter shaft, a balloon shaft, a balloon element, and at least one electrode selected from one or more electrodes; the catheter shaft has a distal end and a proximal end, and the catheter shaft includes a shaft lumen; the balloon shaft is disposed in the shaft lumen in a first state and extends from the catheter shaft in a second state; the balloon element is disposed on the balloon shaft and is inflatable in the second state; at least one electrode selected from one or more electrodes is disposed on the balloon element.

[0008] In some embodiments, the catheter axis defines a first axis; wherein, in a second state, the balloon axis defines a second axis; wherein, the second axis and the first axis form an angle greater than zero degrees. In a particular embodiment, the balloon element has a balloon length along the second axis and a balloon width perpendicular to the second axis; wherein, when the balloon element is inflated, the balloon length is greater than the balloon width. In some embodiments, the balloon element has a balloon length along the second axis and a balloon width perpendicular to the second axis; wherein, when the balloon element is inflated, the balloon length is less than the balloon width. In a particular embodiment, when the balloon element is inflated, the balloon element has a diameter in the range of three millimeters to fifteen millimeters.

[0009] In some embodiments, the balloon element has a first inflated state and a second inflated state; wherein the balloon element has a first balloon diameter in the first inflated state; wherein the balloon element has a second balloon diameter in the second inflated state; wherein the first balloon diameter is different from the second balloon diameter.

[0010] In a particular embodiment, the balloon element includes a first inflatable portion having a first balloon diameter and a second inflatable portion having a second balloon diameter when the balloon element is inflated; wherein the first balloon diameter is different from the second balloon diameter.

[0011] In some embodiments, the balloon element includes a narrow section in the middle of the balloon element; wherein the balloon element includes a first section at a distal end of the balloon element and a second section at a proximal end of the balloon element; wherein the narrow section is between the first and second sections; wherein the narrow section has a diameter smaller than the diameter of the first section or the diameter of the second section. In a particular embodiment, the balloon element has a cross-sectional shape perpendicular to a second axis; wherein the cross-sectional shape is circular, elliptical, or rectangular. In some embodiments, the balloon element includes an anchoring member and a shunt member, the anchoring member being configured to facilitate placement of the balloon element within a patient, the shunt member being mechanically coupled to the anchoring member.

[0012] In certain embodiments, the anchoring member has a first diameter, the shunt member has a second diameter, and the first diameter is larger than the second diameter. In some embodiments, at least one of one or more electrodes is disposed on the shunt member of the balloon element. In certain embodiments, the anchoring member and the shunt member share an internal lumen.

[0013] In some embodiments, the anchoring component is a first balloon, and the shunt component is a second balloon that does not share a lumen with the first balloon. In a particular embodiment, the anchoring component is configured to inflate to a first inflated state, and the shunt component is configured to remain constricted in the first inflated state, wherein the anchoring component is configured to inflate to a second inflated state, and the shunt component is configured to remain constricted in the second inflated state. In some embodiments, the anchoring component is configured to pull the tissue wall back in the first inflated state.

[0014] In certain embodiments, the balloon element is folded into multiple folds in a first state, and wherein a first electrode of one or more electrodes is fully disposed on a fold surface on one side of one of the multiple folds. In some embodiments, at least one of the one or more electrodes has a central portion and multiple protrusions extending from the central portion, wherein at least a portion of the multiple protrusions is parallel. In certain embodiments, the anchoring member has a proximal surface that defines a plane angled relative to the longitudinal axis of the balloon element.

[0015] According to a specific embodiment, a shunt conduit system includes a shunt conduit, a shunt element, and a juxtaposition element. The shunt conduit includes a conduit shaft having a distal end and a proximal end, the conduit shaft including a shaft lumen; the shunt element is disposed within the shaft lumen in a first state and extends from the conduit shaft in a second state; the juxtaposition element is disposed proximal to the shunt element and protrudes from the conduit shaft in the second state. In some embodiments, the shunt conduit system further includes an energy source and a controller; the energy source is connected to the shunt conduit; the controller is connected to the energy source and includes one or more processors; wherein the one or more processors are configured to control the energy source to deliver energy to the shunt conduit.

[0016] In some embodiments, the shunt catheter system further includes an imaging device comprising one or more visualization elements and a display, the one or more visualization elements being positioned near the shunt element to determine the location of the shunt element within the patient's heart; the display being used to visualize that location.

[0017] According to some embodiments, a method for creating a shunt includes: deploying a shunt catheter in a first state, the shunt catheter including a catheter shaft, a shunt element, and a puncture element, the catheter shaft having a distal end and a proximal end, the catheter shaft including a shaft lumen, the shunt element having a proximal end and a distal end, wherein the shunt element is disposed in the shaft lumen in the first state, and the puncture element is disposed near the distal end of the shunt element; positioning the shunt catheter near a target location on a patient; operating the shunt catheter to a second state, wherein the shunt element extends from the catheter shaft at an angle greater than zero degrees at the proximal end of the shunt element in the second state; puncturing an opening at the target location using the puncture element; and expanding the opening using the shunt element.

[0018] In a particular embodiment, the shunt element includes an expandable element disposed at a distal end of the shunt element; wherein the expandable element has multiple states, and wherein the multiple states of the expandable element include a compressed state, a first inflated state, and a second inflated state.

[0019] In some embodiments, the method further includes treating the tissue surrounding the opening using an expandable element in a first or second inflated state. In a particular embodiment, the method further includes using an imaging device to determine the location of the shunt element; wherein the imaging device includes one or more visualization elements disposed proximal to the shunt element. In some embodiments, the method further includes deploying a shunt catheter in a first state, including inserting the shunt catheter into the patient's coronary sinus via the patient's superior or inferior vena cava.

[0020] In certain embodiments, the method further includes removing the shunt catheter from the patient. In some embodiments, the method further includes generating a shunt using a shunt element; wherein the shunt includes an opening between the patient's coronary sinus and left atrium. In certain embodiments, the shunt element includes an expandable element disposed at a distal end of the shunt element. In some embodiments, the expandable element includes an anchoring component and the shunt element. In certain embodiments, the expandable element has multiple states, including a compressed state, a first inflated state, and a second inflated state.

[0021] In some embodiments, using a shunt element to expand the opening includes: positioning an anchoring member distal to a target location; expanding the anchoring member in a first inflated state to position an expandable element; and expanding the shunt element in a second inflated state.

[0022] According to some embodiments, a shunt catheter includes: a catheter shaft having a distal end and a proximal end, the catheter shaft including a shaft lumen, a balloon shaft, and a balloon element, the balloon shaft being disposed in the shaft lumen in a first state and extending from the catheter shaft in a second state, the balloon element being disposed on the balloon shaft in the second state and configured to be inflatable; wherein the balloon element includes an anchoring component and a shunt component, the anchoring component being configured to position the balloon element at a target location on the patient, and the diameter of the shunt component being smaller than the diameter of the anchoring component when both the anchoring component and the shunt component are inflated; wherein the shunt component is configured to deliver ablation energy to the target location on the patient.

[0023] While several embodiments have been disclosed, other embodiments of the invention will become apparent to those skilled in the art from the following “Detailed Description,” which illustrates and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative rather than restrictive in nature. Attached Figure Description

[0024] Figure 1 This is a diagram illustrating an exemplary clinical setup for treating a patient's heart using a shunt catheter system according to an embodiment of this disclosure.

[0025] Figure 2 This is a schematic diagram illustrating an example of a shunt device to be deployed in a patient's heart according to an embodiment of the present disclosure.

[0026] Figure 3 This is a schematic side view of an example of a diversion device according to an embodiment of the present disclosure and a perspective view of the juxtaposed elements of the diversion device.

[0027] Figure 4 This is a schematic cross-sectional view of an example shunt conduit according to an embodiment of the present disclosure.

[0028] Figures 5A to 5C This is a schematic diagram of an example shunt conduit according to an embodiment of the present disclosure.

[0029] Figures 6A to 6C This is a schematic perspective view of an example of a shunt element according to an embodiment of the present disclosure.

[0030] Figure 7 This is a schematic diagram of an example shunt conduit according to an embodiment of the present disclosure.

[0031] Figures 8A to 8D This is a schematic diagram of an example balloon element according to an embodiment of the present disclosure.

[0032] Figures 9A to 9D This is an example of a cross-sectional view of a balloon element according to an embodiment of the present disclosure.

[0033] Figures 10A to 10I This is a schematic diagram of an example of an electrode configuration placed on a balloon element according to a specific embodiment of the present disclosure.

[0034] Figure 11 This is a flowchart illustrating the process of creating a shunt in a patient according to an embodiment of the present disclosure.

[0035] Figure 12 This is a schematic perspective view of an example of a shunt element according to an embodiment of the present disclosure.

[0036] Figure 13 This is a schematic diagram of an example scalable element according to an embodiment of the present disclosure.

[0037] Figure 14 This is a schematic diagram of an example scalable element according to an embodiment of the present disclosure.

[0038] Figure 15 This is a flowchart illustrating the process of creating a shunt in a patient according to an embodiment of the present disclosure.

[0039] While the invention can be modified and presented in various alternative forms, specific embodiments have been shown by way of example in the accompanying drawings and described in detail below. However, the invention is not intended to be limited to the specific embodiments described. Rather, the invention is intended to cover all modifications, equivalents, and alternatives that fall within the scope of the invention as defined by the appended claims. Detailed Implementation

[0040] The following “Detailed Description” is illustrative in nature and is not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the following description provides some practical illustrations for carrying out exemplary embodiments of the invention. Examples of construction, materials, and / or dimensions are provided for selected elements. Those skilled in the art will recognize that many of the examples mentioned have various suitable alternatives.

[0041] Unless otherwise indicated, all figures used in the specification and claims to indicate characteristic dimensions, quantities, and physical properties shall in all cases be understood to be modified by the terms “about” or “approximately”. Correspondingly, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and appended claims are approximate values ​​that may vary according to the desired characteristics sought by a person skilled in the art using the teachings disclosed herein. The numerical ranges used for endpoints include all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5) and any numbers within that range.

[0042] While illustrative methods may be represented by one or more accompanying drawings (e.g., flowcharts, communication flows, etc.), these drawings should not be construed as implying any requirement or specific order of the steps disclosed herein. However, some embodiments may require specific steps and / or a specific order between specific steps, as expressly described herein and / or as can be understood from the nature of the steps themselves (e.g., the performance of some steps may depend on the result of a preceding step). Additionally, a “set,” “subset,” or “group” of items (e.g., inputs, algorithms, data values, etc.) may include one or more items, and similarly, a subset or subgroup of items may include one or more items. “Multiple” means more than one.

[0043] As used herein, the term "based on" is not intended to be restrictive, but rather indicates that a determination, identification, prediction, calculation, etc., is performed by using at least the term following "based on" as input. For example, predicting a result based on a particular piece of information may alternatively be performed based on another piece of information. In some embodiments, the terms "receive" or "receiving" mean obtaining from a data repository (e.g., a database), from another system or service, from another software, or from another software component within the same software. In certain embodiments, the terms "access" or "accessing" mean retrieving data or information, and / or generating data or information.

[0044] Various methods exist for creating an atrial shunt, which is a connection or portal between the left and right atria of a patient's heart for the flow of blood. In some embodiments, examples of atrial shunt devices (IASDs) include implants or shunt catheters. For example, the device is present in the atrial septum, posing a risk of right-to-left shunting and systemic embolism. In some examples, the preservation of the atrial septum is important as the number of left-sided transseptal catheter interventions increases. Improvements to the methods of IASDs are needed for safer and better procedures. At least some embodiments of this disclosure relate to a shunt catheter for deployment across a patient's coronary sinus (CS) to create a shunt between the CS and the patient's left atrium (LA). At least some embodiments of this disclosure relate to a shunt catheter for deployment across a patient's atrial septum (AS) for atrial septal shunt.

[0045] The patient's CS ostium can have a diameter of approximately 10 mm to approximately 20 mm. Because the CS is a relatively small blood vessel, at least some embodiments of this disclosure relate to features of a shunt catheter that helps protect the patient's blood vessel during deployment and / or elements used to stabilize the catheter during procedure. In embodiments, the shunt catheter includes a catheter shaft, a shunt element, and a juxtaposed element disposed near the shunt element. In some embodiments, the catheter shaft is made of a flexible material that is bent to conform to the shape of the patient's CS according to its anatomy. In still other embodiments, the catheter shaft includes a stabilizing element (such as a distal end) having a curve conforming to the shape of the patient's CS (e.g., a pre-existing curve) to help stabilize the catheter and minimize potential damage to the patient's tissue wall (e.g., the vessel wall of the patient's CS).

[0046] In some embodiments, during deployment, a shunt element protrudes from the catheter axis to help stabilize the catheter at the desired location for creating the shunt. In certain embodiments, the shunt element also includes an expandable element (e.g., a balloon) and a tube (e.g., a hypotube) for supporting the expandable element. The tube may have multiple incisions along its length to help facilitate tube bending. In some embodiments, the shunt is formed in the patient's CS vessel by creating an opening between the patient's CS and LA vessels. In certain embodiments, the shunt catheter is inserted through the patient's superior vena cava (SVC) via a transjugular approach. In certain embodiments, the shunt catheter is inserted through the patient's inferior vena cava (IVC) via a transfemoral approach.

[0047] Figure 1 This is a diagram illustrating an exemplary clinical setup 100 for treating the heart 101 of a patient 102 using a shunt catheter system 104 according to an embodiment of this disclosure. The shunt catheter system 104 includes a shunt device 106. As those skilled in the art will understand, the clinical setup 100 may have Figure 1 Other components and component arrangements are not shown. In some embodiments, the shunt catheter system 104 includes or is coupled to an imaging system (e.g., an X-ray system), which may include one or more visualization elements and a display 108. In some embodiments, one or more visualization elements may be disposed on the shunt device 106. In certain embodiments, the imaging system may help guide the physician's manipulation of the shunt catheter 110 during surgery.

[0048] The shunt device 106 includes a shunt catheter 110, a controller 112, and an energy source 114 (e.g., a generator). The controller 112 is configured to control functional aspects of the shunt device 106. In one embodiment, the controller 112 is configured to control the energy source 114 to deliver energy to the shunt catheter 110. The controller 112 may be connected to one or more visualization elements to facilitate positioning of the shunt catheter 110 in the patient's heart during surgery. In some embodiments, the energy source 114 is connected to the controller 112. In still other embodiments, the energy source 114 may be integrated into the controller 112.

[0049] As those skilled in the art will understand, Figure 1 The depiction of the shunt conduit system 104 is intended to provide a general overview of the various components of the shunt conduit system 104 and is not intended in any way to imply that this disclosure is limited to any set of components or arrangement of components. For example, those skilled in the art will readily recognize that the shunt conduit system 104 may and could include additional hardware components (e.g., junction boxes, workstations, etc.).

[0050] According to some embodiments, the shunt device 106 includes a handle 116, a catheter shaft 118, a puncture element (e.g., a puncture needle) configured to puncture a tissue wall, and a shunt element 120 configured to provide a shunt at a target location. In certain embodiments, the shunt element 120 is inflatable and connected to an inflation source 122. In some cases, the shunt element 120 includes an expandable element (e.g., a balloon). In certain embodiments, the shunt element 120 is connected to an energy source 114 to provide a shunt. For example, the shunt element 120 includes electrodes for receiving electrical power from the energy source 114 to deliver energy (e.g., ablation energy, radio frequency (RF) energy, phased-array RF energy, thermal energy, cryo-energy, pulsed ablation energy (e.g., pulsed field ablation (PFA)), microwave energy, laser energy, ultrasound energy, etc.) to a target location (e.g., target tissue) at the wall of a cardiovascular system (e.g., circulatory system).

[0051] In certain embodiments, the handle 116 is configured for user operation to position the puncture element and shunt element 120 at a desired anatomical location. The catheter shaft 118 typically defines the longitudinal axis of the shunt catheter 110. In some embodiments, the shunt element 120 may include a balloon attached to the shunt element shaft positioned within the catheter shaft 118 in a first state (e.g., prior to deployment and / or during deployment to position the shunt element 120). In certain embodiments, the shunt element shaft has a predetermined curve. In some examples, the shunt element shaft has a predefined curve for shunt element deployment. In certain embodiments, the shunt element shaft extends from the catheter shaft 118 in a second state (e.g., a shunt state using the shunt element).

[0052] According to a particular embodiment, during deployment, a shunt device 106, including a catheter shaft 118, is introduced through a patient CS port located in the patient's right atrium. The shunt device 106 can then be oriented via one or more mechanisms within the patient's CS, as will be discussed in more detail below. In some embodiments, to conform to the shape of the patient's CS, the catheter shaft 118 is made of a flexible material that can be bent according to the anatomy of the CS.

[0053] In certain embodiments, the shunt catheter 110 includes a juxtaposition element 124 disposed proximal to the shunt element 120. In some embodiments, the juxtaposition element is disposed within a shaft (e.g., an outer shaft) in a first state. In some embodiments, the juxtaposition element 124 protrudes from the catheter shaft 118 in a first state and / or a second state. In certain embodiments, the juxtaposition element 124 may be attached to a cardiovascular system wall (e.g., the anterior or posterior wall of the CS, the left atrial wall, the right atrial wall, etc.) in a second state, for example, to aid in positioning and / or stabilizing the shunt element 120. In certain embodiments, the juxtaposition element 124 includes a braided structure. In some embodiments, the juxtaposition element 124 may include a nickel-titanium alloy braid that can be retained within the catheter shaft 118. After the catheter shaft 118 has been deployed and stabilized, the shunt element 120, including a puncture element, may be deployed. In some embodiments, the shunt element is configured to deliver energy to target tissue to create a shunt in the patient's CS.

[0054] According to some embodiments, various components of the shunt system 104 (e.g., controller 112) may be implemented on one or more computing devices. The computing device may include any type of computing device suitable for implementing embodiments of this disclosure. Examples of computing devices include dedicated computing devices or general-purpose computing devices (such as workstations, servers, laptops, portable devices, desktop computers, tablet computers, handheld devices, general-purpose graphics processing units (GPGPUs), etc.), all of which are considered in the context of the various components of the reference shunt system 104. Figure 1 Within the range.

[0055] In some embodiments, a computing device (e.g., controller 112) includes a bus that directly and / or indirectly connects to a processor, memory, input / output (I / O) ports, I / O components, and a power supply. The computing device may also include any number of additional components, different components, and / or combinations of components. The bus can represent one or more buses (such as, for example, an address bus, a data bus, or a combination thereof). Similarly, in some embodiments, the computing device may include multiple processors, multiple memory components, multiple I / O ports, multiple I / O components, and / or multiple power supplies. Furthermore, any number of these components or combinations thereof may be distributed and / or replicated across multiple computing devices. In some embodiments, various components or portions of components (e.g., controller 112, shunt 110, etc.) may be integrated into a physical device.

[0056] In some embodiments, the shunt conduit system 104 includes one or more memories (not shown). The one or more memories include computer-readable media in the form of volatile and / or non-volatile memory, transient and / or non-transient storage media, and may be removable, non-removable, or a combination thereof. Examples of media include random access memory (RAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), flash memory, optical or holographic media, magnetic tape cassettes, magnetic tape, disk storage devices or other magnetic storage devices, data transmitters, and / or any other media that can be used to store information and can be accessed by a computing device (e.g., quantum state memory, etc.). In some embodiments, the one or more memories store computer-executable instructions for causing a processor (e.g., controller 90) to implement aspects of embodiments of the system components discussed herein, and / or to perform aspects of embodiments of the methods and processes discussed herein.

[0057] Computer-executable instructions may include, for example, computer code, machine-usable instructions, and such program components, for example, executable by one or more processors associated with a computing device. Program components can be programmed using any number of different programming environments, including various languages, development kits, frameworks, etc. Some or all of the functionality envisioned herein may also be implemented, or alternatively, in hardware and / or firmware.

[0058] In some embodiments, the storage may include a data repository, which may be implemented using any of the configurations described below. The data repository may include random access memory, flat files, XML files, and / or one or more database management systems (DBMS) running on one or more database servers or data centers. The database management system may be a relational database management system (RDBMS), a hierarchical database management system (HDBMS), a multidimensional database management system (MDBMS), an object-oriented database management system (ODBMS or OODBMS), or an object-relational database management system (ORDBMS), etc. The data repository may be, for example, a single relational database. In some cases, the data repository may include multiple databases that can exchange and aggregate data by data integration processes or software applications. In exemplary embodiments, at least a portion of the data repository may be hosted in a cloud data center. In some cases, the data repository may be hosted on a single computer, server, storage device, cloud server, etc. In some other cases, the data repository may be hosted on a network of networked computers, servers, or devices. In some cases, the data repository may be hosted on a tier of data storage devices, including local, regional, and central storage.

[0059] Various components of the shunt duct system 104 can communicate or be connected via communication interfaces (e.g., wired or wireless interfaces). Communication interfaces include, but are not limited to, any wired short-range and wired long-range communication interfaces, or wireless short-range and wireless long-range communication interfaces. Wired interfaces can use cables, umbilical cords, etc. Short-range communication interfaces can be, for example, local area networks (LANs), interfaces conforming to known communication standards (such as Bluetooth™ standards, IEEE 802 standards (e.g., IEEE 802.11)), ZigBee™, or similar specifications (such as specifications based on the IEEE 802.15.4 standard, or specifications based on other public or proprietary wireless protocols). Long-range communication interfaces can be, for example, wide area networks (WANs), cellular network interfaces, satellite communication interfaces, etc. Communication interfaces can be within a private computer network (such as an intranet) or on a public computer network (such as the Internet). Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the invention. For example, while the above embodiments relate to specific features, the scope of the invention also includes embodiments with different combinations of features, and embodiments that do not include all described features. Therefore, the scope of the invention is intended to cover all such alternatives, modifications, and variations falling within the scope of the claims, as well as all their equivalents.

[0060] Figure 2This is a schematic diagram illustrating an example of a shunt device 200 to be deployed in a patient's heart according to an embodiment of the present disclosure. Figure 2 This is merely an example. Those skilled in the art will recognize many variations, substitutions, and modifications. As shown, the shunt device 200 includes a shunt catheter 202 that is delivered through a patient's coronary sinus (CS) 210 via a CS port 211. In some embodiments, the shunt catheter 202 includes a catheter shaft 204, a shunt element 206, and a juxtaposition element 208. In a particular embodiment, the catheter shaft 204 has a curve at its distal end 205. In some embodiments, as shown, the shunt element 206 extends from the catheter shaft 204 in a second state (e.g., a state providing shunt). In a particular example, the shunt element 206 forms an angle greater than 10 degrees with the distal end 205 of the catheter shaft 204. In some examples, the shunt element 206 forms an angle greater than 30 degrees with the distal end 205 of the catheter shaft 204. In some embodiments, the shunt element 206 forms an angle close to 90 degrees with the catheter shaft 204. In some embodiments, the diversion element 206 forms an angle with the conduit shaft 204 in the range of 10 to 120 degrees.

[0061] In some embodiments, the catheter shaft 204 is made of a flexible material that can bend to conform to the anatomy of the patient's CS210. In certain embodiments, for example, the catheter shaft 204 may comprise polyether block amide, nylon, silicone, or combinations thereof. In some cases, the catheter shaft 204 may be a multilayer and multimaterial component. In some examples, the catheter shaft 204 is reinforced with a braid and / or may have an etched or cast lining. The braid used to reinforce the catheter shaft 204 may be made of a nickel-titanium alloy. The lining may be made of a copolymer of polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE), polyamide, and polyether, or combinations thereof. In some embodiments, the catheter shaft 204 is coated with a hydrophilic coating for lubrication, or with other types of coatings known to those skilled in the art suitable for coating catheter shafts.

[0062] In some embodiments, the shunt catheter 202 has a diameter of approximately 2 mm to approximately 5 mm. In a particular embodiment, the shunt catheter 202 has a diameter of approximately 2.5 mm to approximately 4.5 mm. In some embodiments, the diameter of the shunt catheter is approximately 3 mm to approximately 4 mm. In a particular embodiment, the shunt catheter 202 may have a portion that allows the shunt catheter 202 to pass through blood vessels and the cardiovascular system to reach a target location.

[0063] Figure 3 This is a side view of an example of a diversion device 300 according to an embodiment of the present disclosure and a perspective view of the parallel element 308 in the diversion device 300. Figure 3This is merely an example. Those skilled in the art will recognize many variations, substitutions, and modifications. As shown, the shunt device 300 includes a shunt catheter 302 to be delivered through the patient's coronary sinus (CS). The shunt catheter 302 includes a catheter shaft 304, a shunt element 306, and a juxtaposition element 308.

[0064] According to a particular embodiment, the catheter shaft 304 has a distal end 304a, a proximal end (not shown), and a shaft lumen 304b. In some embodiments, the catheter shaft 304 is made of a flexible material that can bend to conform to the anatomy of the patient's CS. In a particular embodiment, the catheter shaft 304 may comprise polyether block amide, nylon, silicone, and / or combinations thereof. In some cases, the catheter shaft 304 may be a multilayer and multimaterial component. In some examples, the catheter shaft 304 is reinforced with a braid and / or may have an etched or cast lining. The braid used to reinforce the catheter shaft 304 may be made of a nickel-titanium alloy. The lining may be made of a copolymer of polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE), polyamide, and polyether, or combinations thereof. In a particular embodiment, the catheter shaft 304 may be injection molded or extruded. In some embodiments, the catheter shaft 304 is coated with a hydrophilic coating or other types of coatings known to those skilled in the art suitable for coating catheter shafts for lubrication. In some cases, the catheter shaft 304 may have multiple lumens.

[0065] According to some embodiments, the catheter shaft 304 may include a stabilizing element (such as a distal end 305 at a distal end 304a) having a curve (e.g., a pre-existing curve), such as a curve conforming to the anatomy of the patient's CS. In some cases, the distal end 305 may be made of a different material than other portions of the catheter shaft 304. In some cases, for example, the distal end 305 may be made of a more flexible material than the material of other portions of the catheter shaft 304. The distal end 305 may be injection molded or machined to have a unique geometry (e.g., a curve) to better stabilize the catheter shaft 304 during deployment.

[0066] According to some embodiments, the distal end 305 may have a length of approximately 5 mm to approximately 85 mm. In a particular embodiment, the catheter shaft 304 includes a shaft opening 304c. In some embodiments, a portion of the catheter shaft from the shaft opening 304c and the distal end 304a has a curve. In some embodiments, the catheter shaft 304 defines a first axis 307, and the shunt element 306 defines a second axis 309 in a second state after deployment. In a particular embodiment, the second axis 309 and the first axis 307 form an angle greater than zero degrees.

[0067] According to some embodiments, the shunt element 306 is disposed within the lumen 304b of the catheter shaft 304 in a first state. In some embodiments, the shunt element 306 includes an expandable element 312 (also referred to as a balloon or balloon element), wherein one end of the expandable element 312 is connected to the shunt element 310 and the other end is connected to a puncture element 314 (e.g., a needle). In a particular embodiment, the expandable element 312 is an elongated element. The shunt element 306 may be connected to the shunt element shaft 310 in a first state (e.g., during deployment, during deployment to position the shunt element 306), the shunt element shaft 310 being positioned within the lumen 304b of the catheter shaft 304. In some embodiments, the shunt element shaft 310 has a predefined curve. In some examples, the shunt element shaft 310 has a predefined curve for the deployment of the shunt element 306. In a particular embodiment, the shunt element shaft extends from the lumen 304b of the catheter shaft 304 in a second state (e.g., the shunt state using the shunt element). In some examples, the expandable element 312 may be a balloon configured to deliver energy (e.g., ablation energy, radio frequency (RF) energy, phased RF energy, thermal energy, cryogenic energy, pulsed ablation energy (e.g., pulsed field ablation (PFA)), microwave energy, laser energy, ultrasonic energy, etc.) to the target tissue, and is a balloon that inflates when the shunt element 306 is in the second state.

[0068] According to a particular embodiment, the width (w) of the expandable element 312 can be in the range of approximately 3 mm to approximately 15 mm. In some embodiments, the width (w) of the expandable element 312 can be in the range of approximately 3.5 mm to approximately 12 mm. In a particular embodiment, the width (w) of the expandable element 312 can be in the range of approximately 4 mm to approximately 10 mm. In some embodiments, the width (w) of the expandable element 312 can be in the range of approximately 4.5 mm to approximately 8 mm.

[0069] According to some embodiments, the shunt catheter 302 also includes an outer shaft 316 disposed outside at least a portion of the catheter shaft 304 during deployment. In some embodiments, the outer shaft 316 is made of a flexible material that can bend to conform to the anatomy of the patient's CS. In particular embodiments, for example, the outer shaft 316 may comprise polyether block amide, nylon, silicone, or combinations thereof. In some cases, the outer shaft 316 may be a multilayer and multimaterial component. In some examples, the outer shaft 316 is reinforced with a braid and may have an etched or cast lining. The braid used to reinforce the catheter shaft 304 may be made of a nickel-titanium alloy. The lining may be made of polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE), copolymers of polyamide and polyether, or combinations thereof. In particular embodiments, the outer shaft 316 may be injection molded or extruded. In some embodiments, the catheter shaft 304 is coated with a hydrophilic coating or other types of coatings known to those skilled in the art suitable for coating catheter shafts for lubrication.

[0070] According to a particular embodiment, the juxtaposition element 308 is disposed within the outer shaft 316 in a first state (e.g., during deployment). In an embodiment, during deployment, the juxtaposition element 308 protrudes from the conduit shaft 304. The juxtaposition element 308 is flexible and compressed to fit within the outer shaft 316, and is configured to depressurize and protrude from the conduit shaft 304 during deployment. In some embodiments, the juxtaposition element 308 is disposed near the shunt element 306 and / or one or more shaft openings 304c. In some cases, the juxtaposition element 308 is a braided structure comprising one or more nickel-titanium wires. In still other cases, the juxtaposition element 308 is made of a flexible material having a portion protruding from the conduit shaft 304. In some examples, the flexible material may be a foam. In some cases, the flexible material may be a balloon filled with a contrast solution that is visualized under fluorescence fluoroscopy. In still other cases, the flexible material may be a polymer with added radiopaque markers for visualization. The radiopaque markers may include tantalum, gold, or any radiopaque markers known to those skilled in the art.

[0071] In certain embodiments, the juxtaposition element 308 is configured to attach to at least one wall in the patient's CS or LA, such that the shunt catheter 302 stabilizes in one position once deployed. According to some embodiments, the juxtaposition element 308 offers several benefits, one of which is the stability of the catheter 302 after deployment. Any movement or lack thereof of the protruding element (e.g., the braided element 318) provides an estimated distance of the catheter 302 from the tissue wall (e.g., the vessel wall of the patient's CS). Furthermore, when the juxtaposition element 308 includes the braided element 318, even when the element 318 is attached to the tissue wall (e.g., the vessel wall of the patient's CS), the openings between the braids still allow blood to flow through the juxtaposition element 308, thus reducing the risk of thrombosis caused by any occlusion in the vessel.

[0072] Figure 4 This is a schematic cross-sectional view of an example of a shunt conduit 400 according to an embodiment of the present disclosure. As shown, the shunt conduit 400 includes a conduit shaft 402 and a shunt element 406, wherein the conduit shaft 402 has a shaft lumen 404, and the shunt element 406 is disposed within the shaft lumen 404 in a first state (e.g., during deployment).

[0073] In some embodiments, the shunt element 406 extends from the catheter shaft 402 in a second state. The shunt element 406 may include an expandable element 412 (e.g., a balloon) with one end connected to the shunt element shaft 410 and the other end connected to a puncture element 414 (e.g., a needle). In some examples, the expandable element 412 may be a balloon configured to deliver energy (e.g., ablation energy, radio frequency (RF) energy, phased-array RF energy, thermal energy, cryo-energy, pulsed ablation energy (e.g., pulsed field ablation (PFA)), microwave energy, laser energy, ultrasound energy, etc.) to target tissue. In some embodiments, the shunt element 406 is positioned within the catheter shaft 402 in a first state (e.g., during deployment to position the shunt element 406). In certain embodiments, the shunt element shaft 410 has a predefined curve. In some examples, the shunt element shaft 410 has a predefined curve for deploying the shunt element 406. In a particular embodiment, the shunt element shaft 410 extends from the conduit shaft 402 in a second state (e.g., a shunt state, a shunt state for using the shunt element).

[0074] According to some embodiments, the catheter shaft 402 includes a shaft opening 402c. In some embodiments, the catheter shaft 402 defines a first axis 407, and a shunt element 406 defines a second axis 409. In a particular embodiment, the expandable element 412 is an elongated element whose length along the second axis 409 is greater than its width perpendicular to the second axis 409. In a particular embodiment, the second axis 409 and the first axis 407 form an angle greater than zero degrees. In a particular example, the second axis 409 and the first axis 407 form an angle greater than 10 degrees. In some embodiments, the second axis 409 and the first axis 407 form an angle close to 90 degrees. In some embodiments, the second axis 409 and the first axis 407 form an angle in the range of 30 degrees to 120 degrees. In some cases, the catheter shaft 402 includes a pre-bent portion formed of a semi-rigid or rigid material connected to the puncture element 414. The semi-rigid or rigid material may include a nickel-titanium alloy or stainless steel (SS), and the semi-rigid or rigid material has a built-in curve prior to deployment.

[0075] In some embodiments, the diverter shaft 410 includes a curved portion 410b forming an arc that connects a first straight portion of the diverter shaft 410a disposed within the shaft cavity 404 and a second straight portion 410c of the diverter shaft 410 extending outward from the shaft cavity 404. In an embodiment, for example as shown, the curved portion 410b of the diverter shaft 410 is adjacent to the shaft opening 402c. In a particular embodiment, an expandable element 412 is located at the second straight portion 410c of the diverter shaft 410 and outside the curved portion 410b of the diverter shaft 410. In some embodiments, the expandable element 412 is an elongated element.

[0076] According to a particular embodiment, the shunt catheter 400 may further include an outer shaft 416, a juxtaposition element 418, and a shunt element 406, the outer shaft 416 being disposed outside and surrounding the catheter shaft 402, and the juxtaposition element 418 being compressed prior to shunt. The outer shaft 416 may have a diameter of approximately 8 french to approximately 18 french, or approximately 8.5 french to approximately 16 french, or approximately 9 french to approximately 14 french, or approximately 9.5 french to approximately 12 french, or may have a diameter within these ranges. In a particular embodiment, for example during deployment, the outer shaft 416 is pulled back to deploy and / or position the catheter shaft 402 (which includes the juxtaposition element 418 and the shunt element 406).

[0077] In certain embodiments, the shunt catheter 400 includes multiple compartments (e.g., lumens) for various elements to provide more targeted control during deployment. For example, the shunt catheter 400 may include an additional lumen between the catheter shaft 402 and the shunt element shaft 410 for more precise control during the deployment of the shunt element 406. Similarly, for example, the shunt catheter 400 may include an additional lumen between the outer shaft 416 and the catheter shaft 402 for more precise control during the deployment of the juxtaposed element 418. In some embodiments, the shunt catheter 400 may include a lumen for receiving functional components (such as guidewire assemblies or drawstring assemblies), as will be discussed further below. In still other embodiments, the shunt catheter 400 may include additional lumens for retaining shunt tissue from the tissue wall.

[0078] Figures 5A to 5C This is a schematic diagram of an example of a shunt conduit 500 according to an embodiment of the present disclosure. As shown, the shunt conduit 500 includes a conduit shaft 502 having a shaft opening 502a, a shaft cavity 504, and a shunt element 506 disposed within the shaft cavity 504 in a first state.

[0079] In some embodiments, such as Figures 5A to 5C As shown, the shunt element 506 extends from the catheter shaft 502 in a second state. In an embodiment, the shunt element 506 includes balloon elements 512a to 512c connected to the balloon shaft 510. In a particular embodiment, the balloon shaft is positioned within the shaft lumen 504 in a first state and extends from the catheter shaft 502 in a second state. In a particular embodiment, the balloon shaft 510 has a predefined curve for deploying the shunt element 506. The balloon shaft 510 may also be connected to a puncture element 514 (e.g., a needle). In some examples, the balloon elements 512a to 512c are configured to deliver energy (e.g., ablation energy, radio frequency (RF) energy, phased-array RF energy, thermal energy, cryo-energy, pulsed ablation energy (e.g., pulsed field ablation (PFA)), microwave energy, laser energy, ultrasound energy, etc.) to treat surrounding tissue.

[0080] In certain embodiments, balloon elements 512a to 512c are made of materials including copolymers of nylon, polyamide and polyether, polyethylene terephthalate (PET), polyurethane (PU), silicone, thermoplastic polyurethane, polyamide, or combinations thereof. In some cases, balloon elements 512a to 512c are multilayered. In certain cases, balloon elements 512a to 512c are disposed on balloon shaft 510 and can inflate during deployment in a second state of shunt element 506. In some embodiments, balloon elements 512a to 512c include at least one electrode from one or more electrodes disposed on balloon elements 512a to 512c.

[0081] According to some embodiments, balloon elements 512a to 512c are disposed at the distal end 510a of the balloon shaft 510 and include multiple states during deployment. In certain embodiments, balloon elements 512a to 512c include at least two states (e.g., deployment state, operational state, etc.). In some embodiments, balloon elements 512a to 512c include three or more states. In some embodiments, for example, as shown... Figure 5A As shown, the balloon element 512a is in a compressed state. In some cases, the balloon element 512a is curled up when in the compressed state. In certain cases, the balloon element 512a comprises multiple layers when in the compressed state. In some examples, the balloon element 512a may be made of a relatively thick and / or rigid material and is folded into pleats when in the compressed state. In certain examples, the balloon element 512a may be made of a relatively thin and / or flexible material and comprises a single layer when in the compressed state. In some embodiments, such as... Figure 5B As shown, the balloon element 512b inflates to a first inflated state (e.g., a half-inflated state). In some embodiments, such as... Figure 5C As shown, balloon element 512c inflates to a second inflation state (e.g., fully inflated state).

[0082] According to a particular embodiment, the catheter shaft 502 defines a first axis 507, and the balloon shaft 510 defines a second axis 509. In a particular embodiment, the second axis 509 and the first axis 507 form an angle greater than zero degrees. In a particular example, the second axis 509 and the first axis 507 form an angle greater than 20 degrees. In a particular example, the second axis 509 and the first axis 507 form an angle greater than 10 degrees. In some embodiments, the second axis 509 and the first axis 507 form an angle close to 45 degrees. In some embodiments, the second axis 509 and the first axis 507 form an angle in the range of 30 degrees to 120 degrees. In a particular example, the second axis 509 and the first axis 507 form an angle close to 90 degrees.

[0083] According to some embodiments, the balloon element 512a, when in a compressed state, has a balloon length (L) along the second axis 509. a ) and the balloon width (W) perpendicular to the second axis 509 a ). Balloon length L a It can range from approximately 4mm to approximately 20mm. Balloon width W aThe balloon element 512a can be approximately 1 mm to approximately 5 mm. In some cases, the balloon element 512a is in a compressed state during the first state of the shunt element 506 (e.g., during deployment). In some cases, the balloon element 512a is in a compressed state when the puncture element 514 is used to puncture the tissue wall. In certain cases, the balloon element 512a is compressed such that the width of the balloon element 512a is smaller than the diameter of the patient's blood vessel (e.g., the coronary sinus).

[0084] According to a specific embodiment, the balloon element 512b, when in a first inflated state, has a balloon length (L) along the second axis 509. b ) and the balloon width (W) perpendicular to the second axis 509 b In some embodiments, when the balloon element is inflated, the balloon 512b (L) b The length of the balloon is greater than that of the 512b (W) b The width of the balloon 512b. The length (L) of the balloon. b ) can be related to the length (L) of the balloon 512a a The balloon 512b (W) is the same as or similar to the balloon 512b. In a particular embodiment, the balloon 512b (W) is similar to the balloon 512b (W) b The width of the balloon element 512b in its semi-inflated state can be in the range of approximately 1 mm to approximately 12 mm, or approximately 1 mm to approximately 10 mm, or approximately 2 mm to approximately 10 mm, or approximately 2 mm to approximately 9 mm, or approximately 2 mm to approximately 8 mm, or approximately 2 mm to approximately 7 mm, or approximately 2 mm to approximately 6 mm, or within the ranges covered by these ranges. In certain cases, the balloon element 512b is in its first inflated state and is configured to treat surrounding tissues by delivering energy or chemicals to the surrounding tissues.

[0085] According to some embodiments, when in the second inflated state, the balloon element 512c has a balloon having a balloon length (L) along the second axis 509. c ) and the balloon width (W) perpendicular to the second axis 509 c In some embodiments, when the balloon element is in the second inflated state, the length (L) of the balloon 512c is... c (W) is greater than the width of balloon 512c. c The length (L) of balloon 512c c ) can be compared with the length of balloon 512b (L) b (The two are) the same or similar. In some cases, such as... Figure 5C As shown, the balloon element 512c inflates to a second inflation state (e.g., a fully inflated state). In some embodiments, the balloon element 512c is an elongated element. In a particular embodiment, the balloon 512c (W cThe width of the balloon element 512c can be in the range of approximately 3 mm to approximately 15 mm, or approximately 3 mm to approximately 12 mm, or approximately 3.5 mm to approximately 12 mm, or approximately 4 mm to approximately 10 mm, or approximately 4.5 mm to approximately 10 mm, or approximately 5 mm to approximately 10 mm, or approximately 5 mm to approximately 8 mm, or within the range covered by these ranges. In certain cases, the balloon element 512c is in a second inflated state (e.g., a fully inflated state) and is configured to treat surrounding tissues by delivering energy or chemicals to the surrounding tissues.

[0086] In some embodiments, balloon elements 512b to 512c inflate to an inflated state in a second state of shunt element 506 (e.g., during shunt). In some cases, balloon element 512a inflates from a compressed state to an inflated state after puncture element 514 punctures the tissue wall.

[0087] In some cases, after balloon element 512a inflates into balloon element 512b or 512c, energy (e.g., ablation energy, radio frequency (RF) energy, phased RF energy, thermal energy, cryogenic energy, pulsed ablation energy (e.g., pulsed field ablation (PFA)), microwave energy, laser energy, ultrasonic energy, etc.) can be delivered to one or more electrodes disposed on balloon element 512b or 512c to ablate the tissue surrounding balloon element 512b or 512c.

[0088] Figures 6A to 6C This is a schematic perspective view of an example of a shunt element 600 according to an embodiment of the present disclosure. As shown, the shunt element 600 includes balloon elements 612a to 612c disposed on a distal end 610a of a balloon shaft 610. Each of the balloon elements 612a, 612b, and 612c has a length (L1, L2, and L3) along the length of the balloon shaft 610 and a width (W1, W2, and W3) perpendicular to the length of the balloon shaft 610. In embodiments, the balloon lengths L1, L2, and L3 are the same or similar to each other. In some embodiments, the balloon widths W1, W2, and W3 are different from each other.

[0089] According to specific embodiments, balloon elements 612a to 612c comprise a film made of a material including copolymers of nylon, polyamide and polyether, polyethylene terephthalate (PET), polyurethane (PU), silicone, thermoplastic polyurethane, polyamide or combinations thereof.

[0090] According to some embodiments, balloon elements 612a to 612c include multiple states. In certain embodiments, balloon elements 612a to 612c include three or more states. In some embodiments, such as... Figure 6AAs shown, the balloon element 612a is rolled up and in a compressed state. In some embodiments, such as... Figure 6B As shown, the balloon element 612b inflates to a first inflated state (e.g., a half-inflated state). In some other embodiments, such as... Figure 6C As shown, the balloon element 612c inflates to a second inflation state (e.g., a fully inflated state).

[0091] In certain embodiments, the balloon element 612a has a length (L1) of approximately 4 mm to approximately 20 mm and a width (W1) of approximately 1 mm to approximately 5 mm. In some cases, such as... Figure 6A As shown, the balloon element 612a is in a compressed state with a pleated configuration, wherein the balloon element 612a is rolled into one or more flat pieces folded together (e.g., one or more pleats 614a). In some cases, each of the one or more pleats 614a may have the same size and thickness.

[0092] In some embodiments, balloon element 612b has a length (L2) of approximately 4 mm to approximately 20 mm and a width (W2) of approximately 1 mm to approximately 5 mm. The length (L2) of balloon 612b may be the same as or similar to the length (L1) of balloon 612a. In some cases, for example as... Figure 6B As shown, balloon element 612b inflates to a first inflated state (e.g., a semi-inflated state). In certain cases, when the balloon element is in the first inflated state, the length (L2) of balloon 612b is greater than the width (W2) of balloon 612b. Each of one or more folds 614b of balloon element 612b inflates in thickness, and the outer edge (e.g., outer edge 616) of each fold 614b may have an average distance of approximately 1 mm to approximately 5 mm from an axis 618 defined by balloon axis 610. In certain cases, balloon element 612b is in the first inflated state and is configured to treat surrounding tissue by delivering energy or chemicals to surrounding tissue.

[0093] In a particular embodiment, balloon element 612c has a length (L3) of approximately 4 mm to approximately 20 mm. The length (L3) of balloon element 612c may be the same as or similar to the length (L1) of balloon element 612a and the length (L2) of balloon element 612b. In some cases, for example as... Figure 6C As shown, the balloon element 612c inflates to a second inflated state (e.g., a fully inflated state). In some embodiments, the balloon element 612c is an elongated element. In certain cases, when the balloon element is in the second inflated state, the length (L3) of the balloon 612c is greater than the width (W3) of the balloon 612c.

[0094] As shown in the figure, balloon element 612c is fully inflated and no longer has a pleated configuration. In some cases, the width of balloon 512c (W3) can be within a wide range, or approximately 3 mm to approximately 15 mm, or approximately 3 mm to approximately 12 mm, or approximately 3.5 mm to approximately 12 mm, or approximately 4 mm to approximately 10 mm, or approximately 4.5 mm to approximately 10 mm, or approximately 5 mm to approximately 10 mm, or approximately 5 mm to approximately 8 mm, or within the range covered by these ranges. In certain cases, balloon element 612c is in a second inflated state and is configured to treat surrounding tissues by delivering energy or chemicals to the surrounding tissues.

[0095] Figure 7 This is a schematic diagram of an example of a shunt catheter 700 according to an embodiment of the present disclosure. As shown, the shunt catheter 700 includes a shunt element 706 that punctures a tissue wall 720 (e.g., the vessel wall of a patient's CS). The shunt element 706 includes a balloon element 712 and a puncture element 714 disposed on a distal end 710a of the balloon shaft 710. In some embodiments, such as... Figure 7 As shown, the balloon element 712 is inflated and in a swollen state. In a particular embodiment, the balloon element 712 includes one or more electrodes 713 disposed on the outer surface of the balloon element 712, wherein the balloon element 712 contacts the wall 720.

[0096] In some embodiments, the shunt element 706 includes a tube 716 (e.g., a hypotube) to support the balloon element 712. The tube 716 may include a plurality of laser cuts 718 generally perpendicular to an axis 709 defined by the shunt element 706. In some cases, the axis 709 is perpendicular to the wall 720. In some cases, the axis 709 forms an angle of approximately 80 degrees to approximately 100 degrees with the wall 710.

[0097] In some cases, the tube 716 is made of a semi-rigid or rigid material (e.g., stainless steel or nickel-titanium alloy) and may also include a drawstring assembly (not shown) to control the deflection or angle of the puncture element 714 relative to the wall 720. Because the balloon element 712 is made of an inflatable and therefore relatively flexible material, the tube 716, made of a relatively more rigid material, positioned along axis 709 in the middle of the balloon element 712 when punctured through the wall 720 with the puncture element 714, helps support the shunt element 706. Multiple laser incisions 718 allow the tube 716 to bend in a specific direction while maintaining the rigidity of the shunt element 706 along axis 709. In some embodiments, the balloon shaft 710 has a pre-formed curve 722 including a radius 724 during deployment.

[0098] In a particular embodiment, the shunt catheter 700 further includes a lumen 728 disposed outside and surrounding the balloon shaft 710. The lumen 728 may also be disposed on the catheter shaft (e.g., Figures 5A to 5B Within the catheter shaft 502. In some cases, the lumen 728 is configured to control the inflation of the balloon element 712. In some examples, the balloon element 712 is in a compressed state during deployment (e.g., as shown in the image). Figure 5A and Figure 6A (As shown in the compressed state). After the needle element 714 punctures the wall 720, the lumen 728 is pulled back, allowing the balloon element 712 to then be inflated (e.g., ...). Figure 1 The air source 122 in the middle can be inflated, or it can be manually inflated by the user based on the desired volume or desired pressure for diversion.

[0099] In some cases, the balloon element 712 has a variable size based on its internal pressure after inflation. In specific situations, such as during shunt procedures, a single balloon can be used to create shunts of various sizes. In specific examples, based on the needs of the physician or patient, a balloon element with variable size and / or variable volume can be used to create shunts with diameters ranging from approximately 3 mm to approximately 15 mm, or approximately 3 mm to approximately 12 mm, or approximately 3.5 mm to approximately 12 mm, or approximately 4 mm to approximately 10 mm, or approximately 4.5 mm to approximately 10 mm, or approximately 4.5 mm to approximately 8 mm, or approximately 4.5 mm to approximately 6 mm, or diameters falling within these ranges. In some examples, the balloon element can be used to create a shunt with a diameter of approximately 5 mm.

[0100] In some embodiments, the shunt catheter 700 includes multiple compartments (e.g., lumens) for various components to provide more targeted control during deployment. For example, in addition to lumen 728, the shunt catheter 700 may include one or more additional lumens for individually accommodating functional components such as guidewire assemblies or traction wire assemblies. In some examples, the shunt catheter 700 may include additional lumens for retaining shunt tissue from the tissue wall.

[0101] Figures 8A to 8D This is a schematic diagram of examples of balloon elements 800a to 800d according to embodiments of the present disclosure. Figure 8AAs shown, the balloon element 800a is in an inflated state and includes a first segment 802a in the middle of the balloon element 800a. In an embodiment, the balloon element includes a second segment 804 and a third segment 808, wherein the second segment 804 is located at the distal end 806 of the balloon element 800a, and the third segment 808 is located at the proximal end 810 of the balloon element 800a. In some embodiments, the distal end 806 of the balloon element 800a is connected to a puncture element 812, and the proximal end 810 of the balloon element 800a is connected to a balloon shaft 814.

[0102] In some embodiments, such as as shown in the figure, the first segment 802a is located between the second segment 804 and the third segment 808. In some cases, the first segment 802a is a narrow segment with a diameter smaller than that of the second segment 804 or the third segment 808.

[0103] In a particular embodiment, the balloon element 800a has a length of approximately 4 mm to approximately 20 mm (l a ), and has a width that varies along the length of the balloon element 800a. In some cases, the width (w) of the balloon element 800a in the first segment 1a The width of the balloon element 800a in the second segment is approximately 5 mm to approximately 15 mm. 2a The second segment 804 and the third segment 808 have the same or similar width, ranging from approximately 5 mm to approximately 15 mm. 1a With w 2a The ratio can be approximately 1:5 to 3:5. In some embodiments, a balloon element with a larger width can be used to create a larger opening. In certain embodiments, balloon elements with variable size and / or variable volume are used to create shunts of various sizes between the patient's coronary sinus and left atrium. In some cases, balloon elements with relatively large widths are used to create shunts with relatively large sizes, such that a large pressure drop may exist in the patient's left atrium due to the creation of the shunt.

[0104] like Figure 8AThe illustrated balloon geometry may be referred to as a waisted geometry, having a narrow segment 802a sandwiched between two thicker segments. In some embodiments, the first segment 802a of the balloon element 800a (e.g., the narrow segment) may be referred to as a “seating area,” for example, designed to accommodate a wall in the cardiovascular system. In certain embodiments, such as during ablation, the first segment 802a of the balloon element 800a directly contacts the patient’s vessel wall, such that tissue walls surround the “seating area” of the balloon 800a. In some cases, the narrow segment (e.g., the first segment 802a) may not be located at the center of the balloon element 800a and may be closer to the distal end 806 or proximal end 810 of the balloon element 800a. In certain cases, an axis 816a passes through the center point of the balloon 800a and is perpendicular to the balloon axis 814. The first axis 816a is typically located in the middle of the first segment 802a of the balloon element 800a. The second axis 818a is defined by the transition between the first segment 802a and the second segment 804. As shown, the angle (e.g., takeoff angle) formed by the second axis 818a and the first axis 816a is between approximately 60 degrees and approximately 85 degrees.

[0105] According to some embodiments, the waist-shaped balloon configuration includes several benefits. For example, during deployment and after inflating the balloon element 800a, the position of the balloon element 800a can be further adjusted based on the position of the first segment 802 (e.g., the narrow segment) relative to the tissue wall (e.g., the patient's blood vessel wall). In some examples, during shunt, the tissue wall can surround and directly contact the narrow segment of the balloon element 800a, thus helping to stabilize the balloon element 800a during shunt and hold it in place.

[0106] like Figure 8BAs shown, balloon element 800b is inflated and has a similar waist geometry to balloon element 800a. In some embodiments, a first segment 802b is located in the middle of balloon element 800b. In still other embodiments, the first segment (e.g., a narrow segment) is closer to the proximal end 810 or distal end 806 of balloon element 800b. In certain cases, axis 816b passes through the center point of balloon 800b and is perpendicular to the balloon axis. The first axis 816b is typically located in the middle of the first segment 802b of balloon element 800b. A second axis 818b is defined by the transition between the first segment 802b and the second segment 804. As shown, the angle (e.g., takeoff angle) formed by the second axis 818b and the first axis 816b is between approximately 15 degrees and approximately 60 degrees. In some embodiments, the angle formed by the second axis 818b and the first axis 816b is smaller than the angle formed by the second axis 818a and the first axis 816a. In certain embodiments, a sharper angle (e.g., a smaller takeoff angle) between the first axis 816a or 816b and the second axis 818a or 818b can help place the balloon 800a to 800b on the patient's blood vessel wall.

[0107] In a particular embodiment, the balloon element 800b has a length of approximately 4 mm to approximately 20 mm (l b ), and has a width that varies along the length of the balloon element 800b. In some embodiments, the first segment 802b has a width (w 1b The width is approximately 4 mm to approximately 20 mm, while the balloon element 800a has a width (w) at the second segment 804. 2b The second segment 804 and the third segment 808 have the same or similar width, ranging from approximately 4 mm to approximately 15 mm. In some cases, w 1b With w 2b The quotient is less than w 1a With w 2a The merchant. w 1b With w 2b The ratio can be from approximately 1:5 to approximately 3:5.

[0108] like Figure 8C As shown, balloon element 800c is in an inflated state and includes a first segment 802c in the middle of balloon element 800c. In an embodiment, balloon element 800c includes a second segment 804c at the distal end 806 of balloon element 800c and a third segment 808c at the proximal end 810 of balloon element 800c. In some embodiments, such as as shown, each of segments 802c, 804c, and 808c includes a straight portion with a constant width; however, the width of the segments of balloon element 800a or 800b varies constantly.

[0109] like Figure 8C The balloon geometry shown can be referred to as a dog bone geometry. In an embodiment, along the length of the balloon element 800c, the first segment 802c has a length (l 1c The second segment 804c has a straight portion of approximately 0.5 mm to approximately 15 mm in length. 2c The third segment 808c has a straight portion of approximately 4 mm to approximately 10 mm and a length of (l) 3c The first segment 802c is a straight portion ranging from approximately 1 mm to approximately 10 mm. In some cases, the first segment 802c is the "placement area" of the balloon element 800c and may have a length approximately the same as the thickness of the patient's vessel wall. In specific cases, the length of the first segment 802c (l) is... 1c The length is approximately 0.5 mm to approximately 4 mm. The length of each straight portion of segments 802c, 804c, and 808c may be the same or different. In some embodiments, the first segment 802c has a smaller width than the second segment 804c. In some embodiments, the second segment 804c has a smaller width than the third segment 808c.

[0110] like Figure 8D As shown, balloon element 800d is in an inflated state and includes a first segment 802d in the middle of balloon element 800d. In an embodiment, balloon element 800d includes a second segment 804d at the distal end 806 of balloon element 800d and a third segment 808d at the proximal end 810 of balloon element 800d. In some embodiments, such as as shown, each of segments 802d, 804d, and 808d includes a straight portion with a constant width; however, the width of the segments of balloon element 800a or 800b is constantly varying.

[0111] like Figure 8D The balloon geometry shown can be described as a stepped geometry. In the embodiment, the first segment 802d has a width of approximately 4 mm to approximately 15 mm. 1d The second segment 804d has a width of approximately 4 mm to approximately 10 mm (w 2d ), and the third segment 808d has a width of approximately 10 mm to approximately 20 mm (w 3d In some embodiments, the second segment 804d is further connected to the puncture element 812 and has the smallest width among the three segments. In some embodiments, the first segment 802d has a width greater than the width of the second segment 804d but less than the width of the third segment 808d.

[0112] In certain embodiments, one or more electrodes 820 are disposed on the outer surface of the balloon 800d around the first segment 802d. In certain embodiments, such as during shunt, the electrodes 820 on the first segment 802d are configured to deliver energy to ablate the tissue surrounding the first segment 802d. In some embodiments, a third segment 808d having a width greater than that of the second segment 802d creates a retraction stop to provide better control over the position of the tissue wall and / or better control over movement along the length of the balloon 800d, thus increasing the stability of the balloon 800d during shunt.

[0113] It should be understood that Figures 8A to 8D The balloon shapes shown are merely examples, and balloons of other shapes or geometries can be used as part of the shunt element of a shunt catheter. In some embodiments, for example, the balloon element may have a conical shape, a spherical shape, a conical shape transitioning to a long square shape, a long spherical shape, an offset shape (e.g., the balloon is partially inflated), a square shape, a conical shape transitioning to a square shape, a conical shape transitioning to a long spherical shape, a tapered shape, or a tapered shape transitioning to an offset shape. In a particular embodiment, the balloon element is symmetrical along the length of the balloon axis. In yet another particular embodiment (e.g., for an offset shape), the balloon element is asymmetrical along the length of the balloon axis.

[0114] Figures 9A to 9D Examples of cross-sections 900a to 9d of a balloon element according to embodiments of the present disclosure are shown. In some embodiments, the balloon element has a cross-sectional shape perpendicular to the balloon element axis, which is circular, elliptical, or substantially square or rectangular with rounded corners. In certain embodiments, different cross-sectional shapes of the balloon element result in shunts of different shapes during shunt operation. Thus, the geometry of the shunt can be the same as or similar to the cross-sectional shape of the balloon element. In some examples, the cross-section of the balloon element has an asymmetrical cross-sectional shape (e.g., an offset-shaped balloon), which is configured to produce a shunt that also has an asymmetrical shape.

[0115] According to some embodiments, such as Figure 9A As shown, the cross-section 900a of the balloon element is circular. According to a specific embodiment, for example... Figure 9B As shown, the cross-section 900b of the balloon element is elliptical. In some embodiments, such as... Figure 9C As shown, the cross-section 900c of the balloon element is a substantially square shape with one or more rounded corners 902. In certain embodiments, such as... Figure 9D As shown, the cross-section 900d of the balloon element is a substantially rectangular shape with one or more rounded corners 904.

[0116] In some embodiments, balloon elements with non-circular cross-sectional shapes can have one or more benefits for ablation. For example, balloon elements with elliptical or rectangular cross-sectional shapes can help provide sufficient area for blood flow within the dimensions of a blood vessel (e.g., a patient's CS). In some cases, balloon elements with elliptical or rectangular cross-sectional shapes offer flexibility by creating shunts of the desired shape and / or diameter. For example, by using a balloon element with an elliptical cross-sectional shape, a shunt can be created in a patient's blood vessel with a smaller width, following the direction of blood flow.

[0117] Figures 10A to 10I This is a schematic diagram illustrating an example of an electrode configuration placed on a balloon element 1000a according to specific embodiments of this disclosure. Figure 10A As shown, the balloon element 1000a has an elongated spherical shape, and a membrane 1002a is disposed on the outer surface of the balloon element 1000a. One or more electrodes may be disposed on the membrane 1002a before it is placed on the balloon element 1000a. In some embodiments, the electrodes are placed on the surface of the balloon element 1000a before being covered by the membrane 1002a. In particular embodiments, the electrodes are configured to deliver energy to surrounding tissue and may include platinum-plated titanium anodes, platinum wires, iridium wires, nickel-titanium alloys, stainless steel, cobalt-chromium, gold, copper, metals encapsulated in silicone sheets, or combinations thereof.

[0118] like Figures 10B to 10D As shown, one or more electrodes 1004b to 1004d have various configurations. In some embodiments, such as... Figure 10B As shown, electrode 1004b has a line pattern. In some embodiments, such as... Figure 10C As shown, electrode 1004c has a grid pattern. In some embodiments, such as... Figure 10D As shown, electrode 1004d is in a curved form. In certain embodiments, the grid pattern of electrode 1004c and the curve of electrode 1004d can reduce strain on the electrode during shunt. In some embodiments, the grid pattern of electrode 1004c and the curve of electrode 1004d can reduce strain on the electrode of balloon element 1000a during coiling.

[0119] like Figures 10E to 10H As shown, electrodes 1004e to 1004h are individually and directly placed on the surface of balloon elements 1000e to 1000h without a membrane. In some embodiments, such as... Figure 10E As shown, electrode 1004e is placed directly on the surface of balloon element 1000e, which has a linear shape. In some embodiments, such as... Figure 10FAs shown, electrode 1004f is placed directly on the surface of balloon element 1000f, and also includes a plurality of individual electrodes 1006f having a thickness of approximately 100 micrometers and protruding from the surface of balloon element 1000f. In certain embodiments, such as... Figure 10G As shown, electrode 1004g has a curved pattern. In some cases, when the electrode is formed with a curved pattern, the effect of any potential deformation of the shape of the balloon element 1000g can be reduced by decreasing the potential changes in the electric field strength and electric field shape around the balloon element 1000g.

[0120] According to a specific embodiment, such as Figure 10H As shown, the balloon element 1000h includes a narrow segment 1006h located in the middle, which is surrounded by segments 1008h and 1010h at both ends of the balloon element 1000h. In a particular embodiment, the balloon element 1000h also includes an electrode 1004h, which has a straight segment 1012h and curved segments 1014h and 1016h at both ends of the balloon element 1000h.

[0121] According to a specific embodiment, such as Figure 10I As shown, the balloon element 1000i includes an electrode 1004i. Although in Figure 10I The example depicts only four electrodes 1004i, but any number of electrodes 1004i can be provided on the balloon element 1000i. In certain cases, the balloon element 1000i may include six, eight, or ten electrodes 1004i. In some embodiments, one or more of the electrodes 1004i have a longitudinal central portion 1020i and a plurality of protrusions 1022i extending from the central portion 1020i. In certain embodiments, at least a portion of the plurality of protrusions 1022i is perpendicular to the longitudinal central portion 1020i. In certain embodiments, at least a portion of the plurality of protrusions 1022i is parallel to each other. In some cases, each of the plurality of protrusions 1022i is parallel to each other.

[0122] According to a specific embodiment, for example, Figure 10IAs shown, electrode 1004i may include portions of non-conductive material 1024i between each of the plurality of protrusions 1022i. In some embodiments, the protrusions 1022i are made of a conductive material and surrounded by the non-conductive material 1024i. Heat can be transferred along the edges of electrode 1004i near the non-conductive material 1024i. In some cases, the non-conductive material 1024i extends toward the central portion 1020i. Therefore, heat can be generated not only at the edges of electrode 1004i furthest from the central portion 1020i, but also along the edges of the plurality of protrusions 1022i between each of them. This allows electrode 1004i to provide more uniform tissue ablation.

[0123] Figure 11 This is a flowchart illustrating a process 1100 for creating a shunt in a patient according to an embodiment of the present disclosure. Aspects of embodiments of process 1100 may be, for example, comprised of a shunt catheter system or a controller (e.g., Figure 1 System 104 in Figure 1 The process is executed by the controller 112. One or more steps of process 1100 are optional and / or can be modified by one or more steps of other embodiments described herein. Additionally, one or more steps of other embodiments described herein can be added to process 1100. In some embodiments, a shunt may be formed in the patient's coronary sinus. In a particular embodiment, the shunt includes an opening between the patient's coronary sinus and left atrium.

[0124] At step 1102, in some embodiments, process 1100 includes deploying a shunt catheter in a first state, the shunt catheter including a catheter shaft having a distal end and a proximal end and an axial lumen, a shunt element having a proximal end and a distal end, and a puncture element disposed near the distal end of the shunt element. In some embodiments, the shunt element is disposed in the axial lumen in the first state. In a particular embodiment, the catheter shaft has an axial opening, and the shunt element extends from the catheter shaft through the axial opening. In a particular embodiment, deploying the shunt catheter includes inserting the shunt catheter through the patient's superior vena cava into the patient's coronary sinus. In a particular embodiment, deploying the shunt catheter includes inserting the shunt catheter through the patient's inferior vena cava into the patient's coronary sinus.

[0125] At step 1104, process 1100 includes positioning the shunt catheter near a target location on the patient. At step 1106, process 1100 includes operating the shunt catheter to a second state, for example, in which the shunt element extends from the catheter shaft at an angle greater than zero degrees at its proximal end. In some embodiments, the shunt catheter includes a juxtaposed element disposed near the shunt element, and this juxtaposed element protrudes from the catheter shaft in the second state. In a particular embodiment, the catheter shaft has an opening, and the shunt element extends from the catheter shaft through this opening.

[0126] At step 1108, process 1100 may include using an imaging device to determine the location of the shunt element. In some embodiments, the imaging device includes one or more visualization elements disposed near the shunt element.

[0127] At step 1110, procedure 1100 includes making a puncture opening at the target location using a puncture element. In some embodiments, the target location is at the patient's coronary sinus. At 1112, procedure 1100 includes using an expandable element (e.g., Figure 3 The expandable element 312 in the middle expands the opening.

[0128] At step 1114, process 1100 includes treating tissue around the opening (e.g., by ablation, displacement, burning, or shrinking tissue) using an expandable element in a first inflated state or a second inflated state. In some embodiments, the shunt element includes an expandable element (e.g., a balloon) disposed at a distal end of the shunt element. In certain embodiments, the expandable element has multiple states, including a compressed state, a first inflated state, and a second inflated state. In some cases, the balloon inflates in the second state and is configured to deliver energy (e.g., ablation energy, radio frequency (RF) energy, phased-array RF energy, thermal energy, cryogenic energy, pulsed ablation energy (e.g., pulsed field ablation (PFA)), microwave energy, laser energy, ultrasonic energy, etc.) to the tissue around the opening.

[0129] At step 1116, process 1100 may include removing the shunt catheter from the patient. In some embodiments, process 1100 may include removing the shunt catheter, which includes removing the catheter shaft, puncture element, and shunt element. In certain embodiments, process 1100 leaves no implanted device at the target location. In some embodiments, the shunt is formed by creating an opening between the patient's coronary sinus and left atrium. In certain embodiments, the shunt catheter is removed from the patient's coronary sinus. In certain embodiments, the formed shunt is an opening that does not include an implant (e.g., a frame or structure supporting the opening). In some embodiments, the shunt consists of an opening between the patient's coronary sinus and left atrium; wherein the shunt does not include an implant.

[0130] According to some embodiments, process 1100 includes generating a shunt using a shunt element of a shunt catheter. In certain embodiments, the shunt includes an expanded opening between the patient's coronary sinus and left atrium. In some embodiments, the shunt does not include any implant.

[0131] Figure 12 This is a schematic perspective view of an example of a shunt element 1200 according to an embodiment of the present disclosure. As shown, the shunt element 1200 includes a balloon element 1212 disposed at the distal end of a balloon shaft 1210. According to some embodiments, the balloon element 1212 includes a film made of a material including copolymers of nylon, polyamide and polyether, polyethylene terephthalate (PET), polyurethane (PU), silicone, thermoplastic polyurethane, polyamide, or combinations thereof.

[0132] According to some embodiments, the balloon element 1212 includes multiple states. In some embodiments, such as... Figure 12 As shown, the balloon element 1212 is coiled and in a compressed state. In some cases, such as... Figure 12 As shown, the balloon element 1212 is in a compressed state with a pleated configuration, wherein the balloon element 1212 is rolled into one or more flat pieces folded together (e.g., one or more pleats 1214). In some cases, each of the one or more pleats 1214 may have the same size and thickness. In some cases, each of the one or more pleats 1214 may include one or more pleating surfaces 1216. In some cases, each of the one or more pleats 1214 may include a first pleating surface 1216a on a first side of the pleat and a second pleating surface 1216b on a second side of the pleat, wherein the second side is opposite to the first side.

[0133] In some embodiments, one of the plurality of electrodes 1204 is completely disposed on a pleated surface on one side of one or more folds 1214. Therefore, when attached to the balloon element 1212 in a compressed state, the likelihood of an electrode bending or folding is reduced, thereby reducing the possibility of damage to the electrode 1204. In some cases, one of the plurality of electrodes 1204 completely disposed on the pleated surface is disposed on the outer surface of one or more folds 1214. For example, the electrode may be disposed on the surface of a fold facing outward from the balloon axis 1210. In some cases, one of the plurality of electrodes 1204 completely disposed on the pleated surface is disposed on the surface of one or more folds 1214 facing the balloon axis 1210.

[0134] In some embodiments, a plurality of electrodes 1204 may be completely disposed on a plurality of pleated surfaces 1216 of one or more pleats 1214. In some cases, at least one electrode of the plurality of electrodes 1204 is completely disposed on each of the one or more pleats 1214 (e.g., disposed on a pleated surface of one or more pleats 1214). In some cases, each electrode or a portion of one or more electrodes of the plurality of electrodes 1204 is completely disposed on a corresponding pleated surface of one or more pleated surfaces 1216.

[0135] Figure 13 This is a schematic diagram of an exemplary scalable element (e.g., balloon element 1300) according to embodiments of the present disclosure. Balloon element 1300 includes an anchoring member 1332 and a shunt member 1330. In a particular embodiment, balloon element 1300 also includes one or more electrodes 1304 disposed on the shunt member 1330. Although in Figure 13 The example depicts only five electrodes 1304, but any number of electrodes 1304 can be provided on the shunt member 1330. In some cases, one or more electrodes 1304 comprise a length substantially equal to the longitudinal length (L) of the shunt member 1330. 1330 The longitudinal length (L) 1304 In certain cases, one or more electrodes 1304 may include a length slightly shorter than the longitudinal length L of the shunt member 1330. 1330 Longitudinal length L 1304 In some cases, the longitudinal length L of one or more electrodes 1304 1304 The longitudinal length L of the diversion component 1330 can be 1330 The range is approximately 70% to approximately 100%, or approximately 80% to approximately 100%, or approximately 90% to approximately 100%.

[0136] In some embodiments, one or more electrodes 1304 have a longitudinal central portion 1320 and a plurality of protrusions 1322 extending from the central portion 1320. In a particular embodiment, at least a portion of the plurality of protrusions 1322 is perpendicular to the longitudinal central portion 1320. In a particular embodiment, at least a portion of the plurality of protrusions 1322 is parallel to each other. In some cases, each of the plurality of protrusions 1322 is parallel to each other.

[0137] According to a specific embodiment, such as Figure 13As shown, one or more electrodes 1304 may be surrounded by a non-conductive material 1324 (e.g., an electrode backing), which includes portions of non-conductive material between each of the plurality of protrusions 1322. Heat can be generated along the edges of the electrodes 1304 near the non-conductive material 1324. Because the non-conductive material 1324 extends toward the central portion 1320, heat can be generated not only at the edges of the electrodes 1304 furthest from the central portion 1320, but also along the edges of the plurality of protrusions 1322 between each of the plurality of protrusions 1322. This allows the electrodes 1304 to provide more uniform tissue ablation.

[0138] In some cases, the balloon element 1300 is in a compressed state in a first state of the shunt element (e.g., during deployment). In some cases, the balloon element 1300 is in a compressed state when the tissue wall is punctured using a puncture element. In some embodiments, the balloon element 1300 inflates to an inflated state in a second state of the shunt element (e.g., during shunt). In some cases, the balloon element 1300 inflates from a compressed state to an inflated state after the puncture element punctures the tissue wall.

[0139] In some embodiments, the balloon element 1300 may inflate to a first inflated state, for example, the anchoring member 1332 inflates and the shunt member 1330 contracts (e.g., not inflated). In some embodiments, such as... Figure 13 As shown, the balloon element 1300 inflates to a second inflated state (e.g., a fully inflated state), where both the anchoring member 1332 and the shunt member 1330 inflate. In some embodiments, when the balloon element 1300 is fully inflated (e.g., in the second inflated state), the anchoring member 1332 has a first diameter, and the shunt member 1330 has a second diameter, wherein the first diameter is larger than the second diameter. In some cases, the first diameter of the anchoring member 1332 in the first inflated state may be in the range of 4 mm to 16 mm. In some examples, the diameter of the anchoring member 1332 in the second inflated state is in the range of 4 mm to 20 mm. In some cases, the difference between the diameter of the anchoring member 1332 (e.g., the first diameter) and the diameter of the diverting member 1330 (e.g., the second diameter) is greater than about 1 mm, or greater than about 1.5 mm, or greater than about 2 mm, or greater than about 2.5 mm, or greater than about 3 mm, or greater than about 3.5 mm, or greater than about 4 mm, or greater than about 4.5 mm, or greater than about 5 mm, or greater than about 6 mm, or greater than about 8 mm, or greater than about 10 mm, or greater than about 12 mm, or greater than about 14 mm, or greater than about 16 mm.

[0140] In some embodiments, the anchoring member 1332 is configured to facilitate placement of the balloon element 1300 within the patient's body (e.g., at a target location on a blood vessel or anatomical structure). In some embodiments, after the puncture element pierces the tissue wall (e.g., the blood vessel wall of the patient's CS), the balloon element 1300 inflates from a compressed state to an inflated state (a first inflated state and / or a second inflated state). The diameter of the anchoring member 1332 when inflated to the inflated state may be substantially larger than the diameter of the puncture hole through the tissue wall, such that when the balloon element 1300 is pulled back through the puncture hole, the anchoring member 1332 is configured to pull the tissue wall back. In some cases, when the anchoring member 1332 is in the first inflated state, the diameter of the anchoring member 1332 is large enough to pull the tissue wall back. In some cases, when the anchoring member 1332 is in the second inflated state, the diameter of the anchoring member 1332 is large enough to pull the tissue wall back. When the anchoring component 1332 pulls the tissue wall back, the position of the balloon element 1300 can be fixed relative to the tissue wall.

[0141] In some embodiments, when the anchoring member 1332 is inflated, the proximal surface 1334 of the anchoring member 1332 can be tilted to secure the balloon element 1300 within the patient's body. The proximal surface 1334 can engage with the tissue wall without enlarging the puncture site in the tissue wall. In some examples (e.g.) Figure 13 As shown, the proximal surface 1334 may define a plane perpendicular to the longitudinal axis of the balloon element 1300. In some cases, the proximal surface 1334 may be inclined in a proximal direction (e.g., the angle between the longitudinal axis of the balloon element 1300 and the proximal surface 1334 on the proximal side of the proximal end 1334 may be less than 90 degrees). In still other cases, the proximal surface 1334 may be inclined in a distal direction (e.g., the angle between the longitudinal axis of the balloon element 1300 and the proximal surface 1334 on the proximal side of the proximal end 1334 may be greater than 90 degrees). In some embodiments, the proximal surface 1334 of the anchoring member 1332 may not form a uniform or constant angle relative to the longitudinal axis of the balloon element 1300. In a particular embodiment, the anchoring member 1332 may have a “canted” shape, wherein a portion of the proximal surface 1334 forms an acute angle with respect to the longitudinal axis of the balloon element 1330, and another portion of the proximal surface 1334 forms an obtuse angle with respect to the longitudinal axis of the balloon element 1330.

[0142] In some embodiments, the diversion component 1330 and the anchoring component 1332 may share an internal cavity, allowing both to inflate simultaneously. In some cases, when the anchoring component 1332 inflates to a first inflated state, the diversion component 1330 may also inflate to a first inflated state. The diameter of the anchoring component 1332 in the first inflated state may be larger than the diameter of the diversion component 1330 in the first inflated state. In some cases, when the anchoring component 1332 inflates to a second inflated state, the diversion component 1330 may also inflate to a second inflated state. The diameter of the anchoring component 1332 in the second inflated state may be larger than the diameter of the diversion component 1330 in the second inflated state.

[0143] The diameter of the shunt component 1330 can be configured to provide shunt to the tissue wall when the balloon element 1300 is inflated (e.g., in a first inflated state and / or a second inflated state). In some cases, after the balloon element 1300 has inflated, such as Figure 13 As shown, energy (e.g., ablation energy, radio frequency (RF) energy, phased RF energy, thermal energy, cryogenic energy, pulsed ablation energy (e.g., pulsed field ablation (PFA)), microwave energy, laser energy, ultrasonic energy, etc.) can be delivered to one or more electrodes 1304 disposed on the shunt component 1330 to ablate tissue surrounding the shunt component 1330.

[0144] Figure 14 This is a schematic diagram of an example scalable element (e.g., balloon element 1400) according to embodiments of the present disclosure. The balloon element 1400 includes an anchoring member 1432 and a diversion member 1430.

[0145] In some embodiments, the balloon element 1400 may inflate to a first inflated state, for example, the anchoring member 1432 inflates and the shunt member 1430 contracts (e.g., not inflated). In some embodiments, such as... Figure 14As shown, the balloon element 1400 inflates to a second inflation state (e.g., a fully inflated state), where both the anchoring member 1432 and the diversion member 1430 inflate. In some embodiments, when the balloon element 1400 is fully inflated (e.g., in the second inflation state), the anchoring member 1432 has a first diameter, and the diversion member 1430 has a second diameter, wherein the first diameter is larger than the second diameter. In some cases, the difference between the diameter of the anchoring member 1432 (e.g., the first diameter) and the diameter of the diversion member 1430 (e.g., the second diameter) is greater than about 1 mm, or greater than about 1.5 mm, or greater than about 2 mm, or greater than about 2.5 mm, or greater than about 3 mm, or greater than about 3.5 mm, or greater than about 4 mm, or greater than about 4.5 mm, or greater than about 5 mm, or greater than about 6 mm, or greater than about 8 mm, or greater than about 10 mm, or greater than about 12 mm, or greater than about 14 mm, or greater than about 16 mm.

[0146] In some embodiments, the anchoring member 1432 is configured to facilitate placement of the balloon element 1400 within the patient's body (e.g., at a target location on a blood vessel or anatomical structure). In some embodiments, after the puncture element pierces the tissue wall, the balloon element 1400 inflates from a compressed state to an inflated state (a first inflated state and / or a second inflated state). The diameter of the anchoring member 1432 when inflated to the inflated state may be substantially larger than the diameter of the puncture hole through the tissue wall, such that when the balloon element 1400 is pulled back through the puncture hole, the anchoring member 1432 is configured to pull the tissue wall back. In some cases, when the anchoring member 1432 is in the first inflated state, the diameter of the anchoring member 1432 is large enough to pull the tissue wall back. In some cases, when the anchoring member 1432 is in the second inflated state, the diameter of the anchoring member 1432 is large enough to pull the tissue wall back. When the anchoring member pulls the tissue wall back, the position of the balloon element 1400 may be fixed relative to the tissue wall.

[0147] In some embodiments, the balloon element 1400 is a multi-balloon element composed of a plurality of independently inflatable balloons. In some cases, the balloon element 1400 may be a dual-balloon design, wherein the anchoring member 1432 is the first balloon and the shunt member 1430 is the second balloon. The first and second balloons may not share a lumen, such that the anchoring member 1432 and the shunt member 1430 can inflate independently of each other.

[0148] In some cases, when the anchoring member 1432 is inflated to a first inflated state, the diverting member 1430 can be configured to remain constricted. In some cases, when the anchoring member 1432 is inflated to a first inflated state, the diverting member 1430 can also inflate to a first inflated state. In some cases, when the anchoring member 1432 is inflated to a first inflated state, the diverting member 1430 can also inflate to a second inflated state. In some cases, when the anchoring member 1432 is inflated to a second inflated state, the diverting member 1430 can be configured to remain constricted. In some cases, when the anchoring member 1432 is inflated to a second inflated state, the diverting member 1430 can also inflate to a first inflated state. In some cases, when the anchoring member 1432 is inflated to a second inflated state, the diverting member 1430 can also inflate to a second inflated state. In some cases, when the diverting component 1430 is inflated to the first inflated state, the anchoring component 1432 may remain contracted. In some cases, when the diverting component 1430 is inflated to the second inflated state, the anchoring component 1432 may remain contracted.

[0149] According to some embodiments, the diameter of the shunt component 1430 can be configured to provide shunt to the tissue wall when the balloon element 1400 is inflated (e.g., a first inflated state and / or a second inflated state). In some cases, after the balloon element 1400 has inflated, such as Figure 14 As shown, energy (e.g., ablation energy, radio frequency (RF) energy, phased RF energy, thermal energy, cryogenic energy, pulsed ablation energy (e.g., pulsed field ablation (PFA)), microwave energy, laser energy, ultrasonic energy, etc.) can be delivered to one or more electrodes disposed on the shunt component 1430 to ablate tissue surrounding the shunt component 1430.

[0150] Figure 15 This is a flowchart illustrating a process 1500 for creating a shunt in a patient according to an embodiment of the present disclosure. Aspects of embodiments of process 1500 may, for example, be provided by a shunt catheter system or a controller (e.g., Figure 1 System 104 in Figure 1 The process is executed by the controller 112. One or more steps of process 1500 are optional and / or can be modified by one or more steps of other embodiments described herein. Additionally, one or more steps of other embodiments described herein can be added to process 1500. In some embodiments, a shunt may be formed in the patient's coronary sinus. In a particular embodiment, the shunt includes an opening between the patient's coronary sinus and left atrium.

[0151] At step 1502, in some embodiments, process 1500 includes deploying a shunt catheter in a first state, the shunt catheter including a catheter shaft having a distal end and a proximal end and an axial lumen, a shunt element having a proximal end and a distal end, and a puncture element disposed near the distal end of the shunt element. In some embodiments, the shunt element is disposed in the axial lumen in the first state. In a particular embodiment, the catheter shaft has an axial opening, and the shunt element extends from the catheter shaft through the axial opening. In a particular embodiment, deploying the shunt catheter includes inserting the shunt catheter through the patient's superior vena cava into the patient's coronary sinus. In a particular embodiment, deploying the shunt catheter includes inserting the shunt catheter through the patient's inferior vena cava into the patient's coronary sinus.

[0152] At step 1504, process 1500 includes positioning the shunt catheter near a target location on the patient. At step 1506, process 1500 includes manipulating the shunt catheter to a second state, for example, in which the shunt element extends from the catheter shaft at an angle greater than zero degrees at its proximal end. In a particular embodiment, the shunt catheter includes a juxtaposed element positioned near the shunt element, and this juxtaposed element protrudes from the catheter shaft in the second state. In a particular embodiment, the catheter shaft has an opening, and the shunt element extends from the catheter shaft through this opening.

[0153] At step 1508, process 1500 may include using an imaging device to determine the location of the shunt element. In some embodiments, the imaging device includes one or more visualization elements disposed near the shunt element.

[0154] At step 1510, process 1500 includes puncturing an opening at a target location using a puncture element. In some embodiments, the target location is at the patient's coronary sinus. In a particular embodiment, the shunt catheter includes an expandable element comprising an anchoring member (e.g., anchoring member 1332) and a shunt member (e.g., shunt member 1330). In some embodiments, process 1500 includes positioning the anchoring member distal to the opening at the target location. At step 1512, process 1500 includes inflating the anchoring member of the expandable element to a first inflated state. In some embodiments, the shunt member remains constricted in the first inflated state. In a particular embodiment, process 1500 includes moving the expandable element proximally to allow the anchoring member to retract the tissue wall at the target location.

[0155] At step 1514, in a particular example, process 1500 includes inflating the expandable element of the shunt component to a second inflated state. In some examples, process 1500 includes using the expandable element (e.g., Figure 3The expandable element 312 in the process extends the opening. In a particular embodiment, process 1500 includes extending the opening using a shunt component with an expandable element.

[0156] At step 1516, process 1500 includes treating tissue around the opening (e.g., by ablation, displacement, burning, or shrinking tissue) using an expandable element in a first or second inflated state. In some embodiments, the shunt element includes an expandable element (e.g., a balloon) disposed at a distal end of the shunt element. In a particular embodiment, the expandable element includes an anchoring component and a shunt component (e.g., anchoring component 1332 and shunt component 1330). In a particular embodiment, each of the anchoring component and the shunt component has multiple states, including a compressed state, a first inflated state, and a second inflated state. In some cases, the shunt component expands in the second state and is configured to deliver energy (e.g., ablation energy, radio frequency (RF) energy, phased-array RF energy, thermal energy, cryogenic energy, pulsed ablation energy (e.g., pulsed field ablation (PFA)), microwave energy, laser energy, ultrasonic energy, etc.) to the tissue around the opening.

[0157] In some embodiments, after the puncture element pierces the tissue wall, the expandable element expands from a compressed state to an inflated state (a first inflated state and / or a second inflated state). When the anchoring member expands to the inflated state, the diameter of the anchoring member may be substantially larger than the diameter of the puncture hole through the tissue wall, such that when the expandable element is pulled back through the puncture hole, the anchoring member is configured to pull the tissue wall back. In some cases, when the anchoring member is in the first inflated state, the diameter of the anchoring member is large enough to pull the tissue wall back. In some cases, when the anchoring member is in the second inflated state, the diameter of the anchoring member is large enough to pull the tissue wall back. When the anchoring member pulls the tissue wall back, the position of the expandable element may be fixed relative to the tissue wall.

[0158] In some embodiments, the diversion component and the anchoring component may share an internal lumen, allowing both to inflate simultaneously. In some embodiments, the diversion component and the anchoring component may be separate inflatable balloons. In some cases, the diversion component and the anchoring component may not share a lumen, allowing them to inflate independently of each other.

[0159] In a particular embodiment, process 1500 includes positioning an anchoring member distal to an opening at a target location, inflating the anchoring member to one of a first inflated state or a second inflated state while the shunt member is held in a compressed state, and moving the expandable element in a proximal direction to allow the anchoring member to pull back the tissue wall at the target location. In a particular embodiment, the subsequent process 1500 includes inflating the shunt member of the expandable element to one of a first inflated state or a second inflated state to expand the opening. In some embodiments, process 1500 then includes using the shunt member to treat tissue around the opening (e.g., by ablation, displacement, burning, or shrinking the tissue).

[0160] At step 1518, process 1500 may include removing the shunt catheter from the patient. In some embodiments, process 1500 may include removing the shunt catheter, which includes removing the catheter shaft, puncture element, and shunt element. In certain embodiments, process 1500 leaves no implanted device at the target location. In some embodiments, the shunt is formed by creating an opening between the patient's coronary sinus and left atrium. In certain embodiments, the shunt catheter is removed from the patient's coronary sinus. In certain embodiments, the formed shunt is an opening that does not include an implant (e.g., a frame or structure supporting the opening). In some embodiments, the shunt consists of an opening between the patient's coronary sinus and left atrium; wherein the shunt does not include an implant.

[0161] According to some embodiments, process 1500 includes generating a shunt using a shunt element of a shunt catheter. In certain embodiments, the shunt includes an expanded opening between the patient's coronary sinus and left atrium. In some embodiments, the shunt does not include any implant.

[0162] According to one aspect, the shunt catheter includes a catheter shaft, a balloon shaft, a balloon element, and at least one electrode selected from one or more electrodes; the catheter shaft has a distal end and a proximal end, and the catheter shaft includes a shaft lumen; the balloon shaft is disposed in the shaft lumen in a first state and extends from the catheter shaft in a second state; the balloon element is disposed on the balloon shaft and is inflatable in the second state; the at least one electrode selected from one or more electrodes is disposed on the balloon element.

[0163] According to another aspect, the catheter axis defines a first axis; wherein the balloon axis defines a second axis in a second state; wherein the second axis and the first axis form an angle greater than zero degrees.

[0164] According to another perspective, this angle is greater than ten degrees.

[0165] According to another perspective, the angle is thirty degrees.

[0166] According to another aspect, the balloon element has a balloon length along the second axis and a balloon width perpendicular to the second axis; wherein, when the balloon element is inflated, the balloon length is greater than the balloon width.

[0167] According to another aspect, the balloon element has a balloon length along the second axis and a balloon width perpendicular to the second axis; wherein when the balloon element is inflated, the balloon length is less than the balloon width.

[0168] On the other hand, when the balloon element is inflated, the diameter of the balloon element is in the range of three to fifteen millimeters.

[0169] On the other hand, when the balloon element is inflated, the diameter of the balloon element is in the range of five to ten millimeters.

[0170] According to another aspect, the balloon element has a first inflated state and a second inflated state; wherein, the balloon element has a first balloon diameter in the first inflated state; wherein, the balloon element has a second balloon diameter in the second inflated state; wherein, the first balloon diameter is different from the second balloon diameter.

[0171] According to another aspect, when the balloon element is inflated, the balloon element includes a first inflatable portion having a first balloon diameter and a second inflatable portion having a second balloon diameter; wherein the first balloon diameter is different from the second balloon diameter.

[0172] According to another aspect, the balloon element includes a narrow section in the middle of the balloon element; wherein the balloon element includes a first section at the distal end of the balloon element and a second section at the proximal end of the balloon element; wherein the narrow section is between the first section and the second section; wherein the narrow section has a diameter smaller than the diameter of the first section or smaller than the diameter of the second section.

[0173] According to another aspect, the balloon element has a cross-sectional shape perpendicular to the second axis; wherein the cross-sectional shape is circular, elliptical or rectangular.

[0174] According to one aspect, a shunt catheter system includes a shunt catheter, a catheter shaft, a shunt element, a juxtaposition element, and an energy source, wherein the shunt catheter includes a catheter shaft having a distal end and a proximal end, the catheter shaft including a shaft lumen; the shunt element is disposed in the shaft lumen in a first state and extends from the catheter shaft in a second state; the juxtaposition element is disposed near the shunt element and protrudes from the catheter shaft in the second state; the energy source is connected to the shunt catheter; and a controller is connected to the energy source including one or more processors; wherein the one or more processors are configured to control the energy source to deliver energy to the shunt catheter.

[0175] According to another aspect, the shunt catheter system also includes an imaging device comprising one or more visualization elements and a display, the one or more visualization elements being positioned near the shunt element to determine the location of the shunt element within the patient's heart; the display being used to visualize that location.

[0176] According to one aspect, a method for creating a shunt includes: deploying a shunt catheter in a first state, the shunt catheter including a catheter shaft, a shunt element, and a puncture element, wherein the catheter shaft has a distal end and a proximal end, the catheter shaft including a shaft lumen, the shunt element having a proximal end and a distal end, wherein the shunt element is disposed in the shaft lumen in the first state, and the puncture element is disposed near the distal end of the shunt element; positioning the shunt catheter near a target location on a patient; operating the shunt catheter to a second state, wherein the shunt element extends from the catheter shaft at an angle greater than zero degrees at the proximal end of the shunt element in the second state; puncturing an opening at the target location using the puncture element; and expanding the opening using the shunt element.

[0177] According to another aspect, the shunt element includes an expandable element disposed at the distal end of the shunt element; wherein the expandable element has multiple states.

[0178] According to another perspective, the multiple states of the expandable element include a compressed state, a first inflated state, and a second inflated state.

[0179] According to another aspect, the method also includes using an expandable element in a first inflated state to treat the tissue around the opening.

[0180] According to another aspect, the method also includes using an expandable element in a second inflated state to treat the tissue around the opening.

[0181] According to another option, the catheter shaft has a shaft opening through which a shunt element extends from the catheter shaft.

[0182] According to another aspect, the method also includes using an imaging device to determine the location of the shunt element; wherein the imaging device includes one or more visualization elements disposed near the shunt element.

[0183] On the other hand, the target location is in the patient's coronary sinus.

[0184] According to another aspect, the method also includes deploying a shunt catheter in a first state, including inserting the shunt catheter into the patient's coronary sinus via the patient's superior vena cava or inferior vena cava.

[0185] According to another approach, the method also includes removing the shunt catheter from the patient.

[0186] According to another aspect, the method also includes using a shunt element to generate a shunt; wherein the shunt includes an expanded opening between the patient's coronary sinus and left atrium.

[0187] On the other hand, the shunt does not include any implant.

[0188] According to one aspect, the shunt catheter includes: a catheter shaft having a distal end and a proximal end, the catheter shaft including a shaft lumen, a balloon shaft, and a balloon element, the balloon shaft being disposed in the shaft lumen in a first state and extending from the catheter shaft in a second state, the balloon element being disposed on the balloon shaft and inflatable in the second state; wherein the balloon is configured to deliver energy (e.g., ablation energy, radiofrequency (RF) energy, phased-array RF energy, thermal energy, cryogenic energy, pulsed ablation energy (e.g., pulsed field ablation (PFA)), microwave energy, laser energy, ultrasound energy, etc.) to a target location on the patient.

[0189] On the other hand, the target location is in the patient's coronary sinus.

[0190] On the other hand, the balloon is configured to expand the opening at the target location.

[0191] According to another aspect, the energy source is configured to transmit energy, including: ablation energy, radio frequency (RF) energy, phased RF energy, thermal energy, cryogenic energy, pulsed ablation energy (e.g., pulsed field ablation (PFA)), microwave energy, laser ablation energy, or ultrasonic energy.

[0192] On the other hand, treating the tissue around the opening includes ablating, displacing, burning, or shrinking the tissue around the opening.

[0193] According to another embodiment, the balloon element includes an anchoring component and a shunt component, wherein the anchoring component is configured to facilitate placement of the balloon element into the patient, and the shunt component is mechanically coupled to the anchoring component.

[0194] According to another aspect, the anchoring member has a first diameter, wherein the diversion member has a second diameter, and wherein the first diameter is larger than the second diameter.

[0195] According to another aspect, at least one of the one or more electrodes is disposed on the shunt component of the balloon element.

[0196] On the other hand, the anchoring component and the diversion component share an internal cavity.

[0197] According to another aspect, the anchoring component is the first balloon, and the shunt component is a second balloon that does not share a lumen with the first balloon.

[0198] According to another aspect, the anchoring component is configured to inflate to a first inflated state, and the diversion component is configured to remain deflated in the first inflated state, wherein the anchoring component is configured to inflate to a second inflated state, and the diversion component is configured to remain deflated in the second inflated state.

[0199] According to another aspect, the anchoring component is configured to pull the tissue wall back in the first inflated state.

[0200] According to another aspect, the diameter of the diversion component in the second inflated state is in the range of 2 mm to 12 mm.

[0201] According to another aspect, the diameter of the anchoring portion in the second inflated state is in the range of 4 mm to 16 mm.

[0202] According to another aspect, the balloon element is folded into multiple folds in the first state, and wherein a first electrode of one or more electrodes is completely disposed on the fold surface on one side of one of the multiple folds.

[0203] According to another aspect, at least one of the one or more electrodes has a longitudinal central portion and a plurality of protrusions extending from the central portion, wherein at least a portion of the plurality of protrusions is parallel.

[0204] According to another aspect, the anchoring component has a proximal surface that defines a plane perpendicular to the longitudinal axis of the balloon element.

[0205] According to another aspect, the anchoring component has a proximal surface that forms an angle of less than 90 degrees with respect to the longitudinal axis of the balloon element.

[0206] According to another aspect, the anchoring component has a proximal surface that forms an angle greater than 90 degrees with respect to the longitudinal axis of the balloon element.

[0207] According to another aspect, the anchoring component has an inclined shape such that a first portion of the proximal surface of the anchoring component forms an acute angle with respect to the longitudinal axis of the balloon element, and a second portion of the proximal surface of the anchoring component forms an obtuse angle with respect to the longitudinal axis of the balloon element.

[0208] On the other hand, the target location is located in the patient's atrial septum.

[0209] According to another aspect, the shunt element includes an expandable element disposed at a distal end of the shunt element, wherein the expandable element includes an anchoring member having multiple states including a compressed state, a first inflated state, and a second inflated state, wherein the method includes: when the anchoring member is disposed distal to the target location, inflating the anchoring member to one of the first inflated state or the second inflated state; moving the shunt element in a proximal direction to allow the anchoring member to pull back the tissue wall at the target location.

[0210] Various modifications and additions may be made to the exemplary embodiments discussed without departing from the scope of this disclosure. For example, while the above embodiments relate to specific features, the scope of the invention also includes embodiments with different combinations of features, and embodiments that do not include all of the stated features. Therefore, the scope of the invention is intended to include all such alternatives, modifications, and variations falling within the scope of the claims, as well as all their equivalents.

Claims

1. A shunt catheter comprising: a catheter shaft having a distal end and a proximal end, the catheter shaft comprising a shaft lumen; a balloon shaft disposed in the shaft lumen in a first state and extending from the catheter shaft in a second state; a balloon element disposed on the balloon shaft and inflatable in the second state; and at least one electrode of one or more electrodes disposed on the balloon element, wherein the balloon element comprises a plurality of pleats in the first state; wherein a first pleat of the plurality of pleats comprises a first pleating surface on a first side of the first pleat and a second pleating surface on a second side of the first pleat; wherein the second side is opposite the first side; wherein a first electrode of the one or more electrodes is disposed entirely on the first pleating surface in the first state; wherein a second electrode of the one or more electrodes is disposed entirely on the second pleating surface in the first state.

2. The shunt catheter of claim 1, wherein, the catheter shaft defines a first axis; wherein the balloon shaft defines a second axis in the second state; wherein the second axis and the first axis form an angle greater than zero degrees.

3. The shunt catheter of claim 2, wherein, the balloon element has a balloon length along the second axis and a balloon width perpendicular to the second axis; wherein the balloon length is greater than the balloon width when the balloon element is inflated.

4. The shunt catheter of claim 2, wherein, the balloon element has a balloon length along the second axis and a balloon width perpendicular to the second axis; wherein the balloon length is less than the balloon width when the balloon element is inflated.

5. The shunt catheter of claim 2, wherein, the balloon element has a cross-sectional shape perpendicular to the second axis; wherein the cross-sectional shape is circular, elliptical, or rectangular.

6. The shunt catheter of claim 1, wherein, the balloon element has a diameter in a range of three millimeters to fifteen millimeters when the balloon element is inflated.

7. The shunt catheter of claim 1, wherein, the balloon element has a first inflated state and a second inflated state; wherein the balloon element has a first balloon diameter in the first inflated state; wherein the balloon element has a second balloon diameter in the second inflated state; wherein the first balloon diameter is different than the second balloon diameter.

8. The shunt catheter of claim 1, wherein, the balloon element comprises a first inflatable portion having a first balloon diameter and a second inflatable portion having a second balloon diameter when the balloon element is inflated; wherein the first balloon diameter is different than the second balloon diameter.

9. The shunt catheter of claim 1, wherein, the balloon element comprises a narrow section in a middle of the balloon element; wherein the balloon element comprises a first section at a distal end of the balloon element and a second section at a proximal end of the balloon element; wherein the narrow section is between the first section and the second section; wherein the narrow section has a diameter that is less than a diameter of the first section or a diameter of the second section.

10. The shunt catheter of claim 1, wherein, the balloon element comprises: an anchoring component configured to facilitate placement of the balloon element in a patient; and a shunting component mechanically coupled to the anchoring component.

11. The shunt catheter of claim 10, wherein, The anchor component has a first diameter in the second state, wherein the shunt component has a second diameter in the second state, and wherein the first diameter is greater than the second diameter.

12. The shunt catheter of claim 10, wherein, The at least one of the one or more electrodes is disposed on the shunt component of the balloon element.

13. The shunt catheter of claim 10, wherein, The anchor component and the shunt component share an inner lumen.

14. The shunt catheter of claim 10, wherein, The anchor component is a first balloon and the shunt component is a second balloon that does not share a lumen with the first balloon.

15. The shunt catheter of claim 10, wherein, The anchor component is configured to be inflated in a first inflated state and the shunt component is configured to remain deflated in the first inflated state, wherein the anchor component is configured to remain inflated in a second inflated state and the shunt component is configured to be inflated in the second inflated state.

16. The shunt catheter of claim 10, wherein, The anchor component is configured to pull back a tissue wall in a first inflated state.

17. The shunt catheter of claim 10, wherein, The anchor component has a proximal surface that defines a plane that is angled relative to a longitudinal axis of the balloon element in the second state.

18. The shunt catheter of claim 1, wherein, The at least one of the one or more electrodes has a central portion and a plurality of protrusions extending from the central portion, wherein at least a portion of the plurality of protrusions are parallel.

19. The shunt catheter of claim 1, wherein, The first electrode extends generally parallel to the balloon shaft in the first state.

20. The shunt catheter of claim 1, wherein, The at least one of the one or more electrodes comprises a grid pattern.

21. A shunt catheter, comprising: a catheter shaft having a distal end and a proximal end, the catheter shaft comprising a shaft lumen; a balloon shaft disposed in the shaft lumen in a first state and extending from the catheter shaft in a second state; a balloon element disposed on the balloon shaft and configured to be inflatable in the second state; and at least one of one or more electrodes disposed on the balloon element, wherein the balloon element comprises an anchor component and a shunt component, the anchor component is configured to position the balloon element at a target location of a patient, and the shunt component has a smaller diameter than a diameter of the anchor component when both the anchor component and the shunt component are inflated; wherein the shunt component is configured to deliver ablation energy to the target location of the patient; wherein the balloon element comprises a plurality of pleats in the first state; wherein a first pleat of the plurality of pleats comprises a first tuck surface on a first side of the first pleat and a second tuck surface on a second side of the first pleat; wherein the second side is opposite the first side; wherein a first electrode of the one or more electrodes is disposed entirely on the first tuck surface in the first state; wherein a second electrode of the one or more electrodes is disposed entirely on the second tuck surface in the first state.

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