Shunt catheter including an expandable element - Patent Application 20070122997

Abstract

At least some embodiments of the present disclosure relate to systems and methods for forming a shunt in a patient. In some embodiments, 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 disposed within 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 expandable in the second state; and at least one electrode of one or more electrodes disposed on the balloon element.

Description

[Technical Field]

[0001] Certain embodiments of the present disclosure relate to medical systems, devices, and methods for creating a shunt in a patient. More particularly, some embodiments of the present disclosure relate to medical systems, devices, and methods for creating a shunt on a wall of a patient's cardiovascular system. [Background technology]

[0002] Heart failure is a serious condition that occurs when the heart cannot pump enough blood and oxygen to support other organs in the body. Heart failure is classified according to left ventricular (LV) function as "heart failure with reduced ejection fraction (EF)" (HFrEF, EF < 40%), "midrange EF" (HFmrEF, EF 40–49%), or "preserved EF" (HFpEF, EF ≥ 50%). Approximately half of patients with heart failure have HFpEF. HFpEF typically occurs during exercise when LV and left atrial filling pressures increase significantly, resulting in an associated increase in pulmonary artery pressure, leading to pulmonary congestion. Structural interventions to reduce elevated left or right atrial filling pressures have received increasing attention.

[0003] Studies in heart failure have shown that lowering left atrial pressure can reduce cardiovascular events while improving functional capacity. Creation of an interatrial shunt has emerged as a therapy for decompressing the left atrium in patients with acute and chronic left-sided heart failure. Therefore, attention has turned to the development of interatrial shunt devices (IASDs) as a means of reducing the harmful increase in left-sided filling pressure caused by exercise to improve overall symptoms. IASDs can be used to treat various types of heart failure and / or other diseases that may result in excessive pressure in a patient's right atrium. Summary of the Invention

[0004] Current IASDs reside in the interatrial septum, carrying the risk of right-to-left shunting and systemic embolism. Furthermore, protection of the interatrial septum is crucial as the number of left-sided transseptal transcatheter interventions increases. Methods to improve IASDs for safer and more successful procedures are needed.

[0005] According to some embodiments, 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 disposed within 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 expandable in the second state; and at least one electrode of the one or more electrodes disposed on the balloon element.

[0006] In some embodiments, the catheter shaft defines a first axis, and the balloon shaft defines a second axis in the second state, the second axis and the first axis forming an angle greater than 0 degrees. In certain embodiments, 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. In some embodiments, 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. In certain embodiments, the balloon element has a diameter in the range of 3 millimeters to 15 millimeters when the balloon element is inflated.

[0007] In some embodiments, the balloon element has a first expanded state and a second expanded state, the balloon element having a first balloon diameter in the first expanded state and the balloon element having a second balloon diameter in the second expanded state, the first balloon diameter being different from the second balloon diameter.

[0008] In certain embodiments, 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, the first balloon diameter being different from the second balloon diameter.

[0009] In some embodiments, the balloon element includes a narrow section in the center of the balloon element, the balloon element including a first section at a distal end of the balloon element and a second section at a proximal end of the balloon element, the narrow section being between the first and second sections and having a diameter smaller than the diameter of the first section or the diameter of the second section. In certain embodiments, the balloon element has a cross-sectional shape perpendicular to the second axis, the cross-sectional shape being circular, elliptical, or rectangular. In some embodiments, the balloon element includes an anchor component configured to facilitate placement of the balloon element within the patient's body and a shunt component mechanically coupled to the anchor component.

[0010] In certain embodiments, the anchor component has a first diameter and the shunt component has a second diameter, the first diameter being greater than the second diameter. In some embodiments, at least one electrode of the one or more electrodes is disposed on the shunt component of the balloon element. In certain embodiments, the anchor component and the shunt component share an internal lumen.

[0011] In some embodiments, 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. In certain embodiments, the anchor component is configured to expand to a first expanded state, the shunt component is configured to remain contracted in the first expanded state, and the anchor component is configured to expand to a second expanded state, and the shunt component is configured to remain contracted in the second expanded state. In some embodiments, the anchor component is configured to retract the tissue wall in the first expanded state.

[0012] In certain embodiments, the balloon element is folded into a plurality of pleats in the first state, and a first electrode of the one or more electrodes is disposed entirely on a pleat surface on one side of one of the plurality of pleats. In some embodiments, at least one electrode of the one or more electrodes has a central portion and a plurality of protrusions extending from the central portion, at least some of the plurality of protrusions being parallel. In certain embodiments, the anchor component has a proximal surface defining a plane angled with respect to the longitudinal axis of the balloon element.

[0013] According to certain embodiments, the shunt catheter system includes a shunt catheter, the shunt catheter including: a catheter shaft having a distal end and a proximal end, the catheter shaft including a shaft lumen, a shunt element disposed within the shaft lumen in a first state and extending from the catheter shaft in a second state, and an apposition element disposed proximate to the shunt element and protruding from the catheter shaft in the second state. In some embodiments, the shunt catheter system further includes an energy source connected to the shunt catheter and a controller connected to the energy source, the controller including one or more processors configured to control the energy source to deliver energy to the shunt catheter.

[0014] In some embodiments, the shunt catheter system further includes an imaging device that includes one or more visualization elements positioned in proximity to the shunt element to determine the position of the shunt element within the patient's heart, and a display for visualizing the position.

[0015] 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 having a distal end and a proximal end, the catheter shaft including a shaft lumen; a shunt element having a proximal end and a distal end, the shunt element being disposed within the shaft lumen in the first state; and a puncture element disposed adjacent to the distal end of the shunt element; positioning the shunt catheter near a target location in a patient; manipulating the shunt catheter to a second state, the shunt element extending from the catheter shaft at an angle greater than 0 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 dilating the opening using the shunt element.

[0016] In certain embodiments, the shunt element includes an expandable element disposed at a distal end of the shunt element, the expandable element having a plurality of states, the plurality of states of the expandable element including a compressed state, a first expanded state, and a second expanded state.

[0017] In some embodiments, the method further includes treating tissue surrounding the opening using the expandable element in the first expanded state or the second expanded state. In certain embodiments, the method further includes determining the position of the shunt element using an imaging device, the imaging device including one or more visualization elements positioned proximate to the shunt element. In some embodiments, the method further includes deploying the shunt catheter in the first state, including inserting the shunt catheter through the patient's superior vena cava or inferior vena cava and into the patient's coronary sinus.

[0018] In certain embodiments, the method further includes removing the shunt catheter from the patient. In some embodiments, the method further includes creating a shunt using a shunt element, the shunt including an opening between the coronary sinus and the left atrium of the patient. 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 anchor component and the shunt element. In certain embodiments, the expandable element has a plurality of states including a compressed state, a first expanded state, and a second expanded state.

[0019] In some embodiments, expanding the opening using the shunt element includes positioning an anchor component distal to the target location, expanding the anchor component in a first expanded state to position the expandable element, and expanding the shunt component in a second expanded state.

[0020] 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 disposed within the shaft lumen in a first state and extending from the catheter shaft in a second state; and a balloon element disposed on the balloon shaft and configured to be expandable in the second state, the balloon element including an anchor component and a shunt component, the anchor component configured to position the balloon element at a target location in a patient, the shunt component having a diameter smaller than a diameter of the anchor component when both the anchor component and the shunt component are expanded, and the shunt component configured to deliver ablation energy to the target location in a patient.

[0021] While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

[0022] While the present invention is susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. It is not, however, the intention to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims. [Brief explanation of the drawings]

[0023] [Figure 1] FIG. 1 illustrates an exemplary clinical setting for treating a patient's heart using a shunt catheter system according to an embodiment of the present disclosure. [Figure 2] 1 is a schematic diagram illustrating an example of a shunt device deployed in a patient's heart, according to an embodiment of the present disclosure. [Figure 3] 1 is a schematic diagram of a side view of an example shunt device and a perspective view of an apposition element of the shunt device, in accordance with an embodiment of the present disclosure. [Figure 4] 1 is a schematic diagram of a cross-sectional view of an example shunt catheter, in accordance with an embodiment of the present disclosure. [Figure 5A] 1 is a schematic diagram illustrating an example of a shunt catheter, according to an embodiment of the present disclosure. [Figure 5B] 1 is a schematic diagram illustrating an example of a shunt catheter, according to an embodiment of the present disclosure. [Figure 5C] 1 is a schematic diagram illustrating an example of a shunt catheter, according to an embodiment of the present disclosure. [Figure 6A] 1 is a schematic diagram of a perspective view of an example shunt element, according to an embodiment of the present disclosure. [Figure 6B] 1 is a schematic diagram of a perspective view of an example shunt element, according to an embodiment of the present disclosure. [Figure 6C] 1 is a schematic diagram of a perspective view of an example shunt element, according to an embodiment of the present disclosure. [Figure 7] 1 is a schematic diagram illustrating an example of a shunt catheter, according to an embodiment of the present disclosure. [Figure 8A] 1A-1C are schematic diagrams illustrating examples of balloon elements, according to embodiments of the present disclosure. [Figure 8B] 1A-1C are schematic diagrams illustrating examples of balloon elements, according to embodiments of the present disclosure. [Figure 8C] 1A-1C are schematic diagrams illustrating examples of balloon elements, according to embodiments of the present disclosure. [Figure 8D] 1A-1C are schematic diagrams illustrating examples of balloon elements, according to embodiments of the present disclosure. [Figure 9A] 1 is an example of a cross-sectional view of a balloon element according to an embodiment of the present disclosure. [Figure 9B] 1 is an example of a cross-sectional view of a balloon element according to an embodiment of the present disclosure. [Figure 9C] 1 is an example of a cross-sectional view of a balloon element according to an embodiment of the present disclosure. [Figure 9D] 1 is an example of a cross-sectional view of a balloon element according to an embodiment of the present disclosure. [Figure 10A] Schematic diagrams illustrating examples of electrode configurations disposed on balloon elements, in accordance with certain embodiments of the present disclosure. [Figure 10B] Schematic diagrams illustrating examples of electrode configurations disposed on balloon elements, in accordance with certain embodiments of the present disclosure. [Figure 10C] Schematic diagrams illustrating examples of electrode configurations disposed on balloon elements, in accordance with certain embodiments of the present disclosure. [Figure 10D] Schematic diagrams illustrating examples of electrode configurations disposed on balloon elements, in accordance with certain embodiments of the present disclosure. [Figure 10E] Schematic diagrams illustrating examples of electrode configurations disposed on balloon elements, in accordance with certain embodiments of the present disclosure. [Figure 10F] Schematic diagrams illustrating examples of electrode configurations disposed on balloon elements, in accordance with certain embodiments of the present disclosure. [Figure 10G]Schematic diagrams illustrating examples of electrode configurations disposed on balloon elements, in accordance with certain embodiments of the present disclosure. [Figure 10H] Schematic diagrams illustrating examples of electrode configurations disposed on balloon elements, in accordance with certain embodiments of the present disclosure. [Figure 10I] Schematic diagrams illustrating examples of electrode configurations disposed on balloon elements, in accordance with certain embodiments of the present disclosure. [Figure 11] 1 is a flow diagram illustrating a process for creating a shunt in a patient according to an embodiment of the present disclosure. [Figure 12] 1 is a schematic diagram of a perspective view of an example shunt element, according to an embodiment of the present disclosure. [Figure 13] 1 is a schematic diagram illustrating an exemplary expandable element, according to an embodiment of the present disclosure. [Figure 14] 1 is a schematic diagram illustrating an exemplary expandable element, according to an embodiment of the present disclosure. [Figure 15] 1 is a flow diagram illustrating a process for creating a shunt in a patient according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0024] The following detailed description is exemplary in nature and is not intended to limit in any way the scope, applicability, or configuration of the present invention. Rather, the following description provides some practical illustrations for implementing exemplary embodiments of the present invention. Examples of configurations, materials, and / or dimensions are provided for selected elements. Those skilled in the art will recognize that many of the described examples have various suitable alternatives.

[0025] Unless otherwise indicated, all numbers expressing size, quantity, and physical properties of features used in the specification and claims are to be understood as being modified in all instances by the term "about." Accordingly, unless otherwise indicated, the numerical parameters set forth in the foregoing specification and appended claims are approximations that may vary depending upon the desired properties sought to be obtained by those of ordinary skill in the art utilizing the teachings disclosed herein. The use of numerical ranges by endpoints includes 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 number within that range.

[0026] Although an example method may be represented by one or more drawings (e.g., flow diagrams, communication flows, etc.), the drawings should not be construed as implying any requirement of or a particular order between the various steps disclosed herein. However, some embodiments may require certain steps and / or a particular order between certain steps (e.g., the performance of some steps may depend on the results of previous steps), as may be explicitly described herein and / or as can be understood from the nature of the steps themselves. 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. "Plurality" means more than one.

[0027] As used herein, the term "based on" is not meant to be limiting, but rather indicates that a determination, identification, prediction, calculation, etc. is performed using at least the term following "based on" as input. For example, predicting an outcome based on particular information may additionally or alternatively base the same determination on other information. In some embodiments, the term "receive" or "receiving" refers to obtaining from a data repository (e.g., a database), from another system or service, from other software, or from another software component within the same software. In particular embodiments, the term "access" or "accessing" refers to retrieving data or information and / or generating data or information.

[0028] There are various approaches for creating an interatrial shunt, which is a connection or gateway between the left and right atria of a patient's heart for blood flow. In some embodiments, an example interatrial shunt device (IASD) includes an implant or shunt catheter. For example, the device resides in the atrial septum, with the associated risk of right-to-left shunting and systemic embolism. In some instances, protection of the atrial septum is important as the number of left-sided transseptal transcatheter interventions increases. Methods for improving IASDs for safer and better procedures are needed. At least some embodiments of the present disclosure are directed to a shunt catheter for deployment through a patient's coronary sinus (CS) to create a shunt between the patient's CS and the patient's left atrium (LA). At least some embodiments of the present disclosure are directed to a shunt catheter for deployment through a patient's atrial septum (AS) for an atrial-septal shunt.

[0029] The ostium of a patient's CS may have a diameter of about 10 mm to about 20 mm. Because the CS is a relatively small vessel, at least some embodiments of the present disclosure are directed to features of a shunt catheter that help protect the patient's vessel during deployment and / or elements for stabilizing the catheter during the procedure. In embodiments, the shunt catheter includes a catheter shaft, a shunt element, and an apposition element positioned proximal to the shunt element. In some embodiments, the catheter shaft is made of a flexible material that bends according to the anatomy of the CS to conform to the shape of the patient's CS. Furthermore, in some embodiments, the catheter shaft includes a stabilizing element, such as a distal tip, having a curve (e.g., a pre-existing curve) that conforms to the shape of the patient's CS to help stabilize the catheter and minimize potential damage to the patient's tissue walls (e.g., the vessel walls of the patient's CS).

[0030] In some embodiments, an apposition element protrudes from the catheter shaft during deployment to help stabilize the catheter in a desired position to create the shunt. In certain embodiments, the shunt element further 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 notches along it to help facilitate bending of the tube. In some embodiments, the shunt is formed in the patient's CS vessel by creating an opening between the patient's CS and LA. 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.

[0031] FIG. 1 illustrates an exemplary clinical setting 100 for treating a heart 101 of a patient 102 using a shunt catheter system 104 according to an embodiment of the present disclosure. The shunt catheter system 104 includes a shunt device 106. As will be understood by those skilled in the art, the clinical setting 100 may have other components and arrangements of components not shown in FIG. 1 . In some embodiments, the shunt catheter system 104 includes or is coupled to an imaging system (e.g., an X-ray system) that may include one or more visualization elements and a display 108. In some embodiments, the one or more visualization elements may be disposed on the shunt device 106. In certain embodiments, the imaging system may help guide a physician's manipulation of the shunt catheter 110 during a procedure.

[0032] 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 embodiments, 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 within the patient's heart during a procedure. In some embodiments, the energy source 114 is connected to the controller 112. Further, in some embodiments, the energy source 114 may be integrated into the controller 112.

[0033] 1 is intended to provide a general overview of the various components of the shunt catheter system 104 and is in no way intended to imply that the present disclosure is limited in any way to any set of components or arrangement of components. For example, one skilled in the art will readily recognize that additional hardware components, e.g., breakout boxes, workstations, etc., can and likely will be included in the shunt catheter system 104.

[0034] 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 penetrate and puncture a tissue wall, and a shunt element 120 configured to perform shunting at a target location. In certain embodiments, the shunt element 120 is expandable and connected to an expansion source 122. In some examples, 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 perform shunting. For example, the shunt element 120 includes electrodes for receiving power from the energy source 114 and delivering energy (e.g., ablation energy, radiofrequency (RF) energy, phased 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 (e.g., target tissue) in a cardiovascular (e.g., circulatory) wall.

[0035] In certain embodiments, the handle 116 is configured to be manipulated by a user to position the puncture element and the shunt element 120 at a desired anatomical location. The catheter shaft 118 generally defines a longitudinal axis of the shunt catheter 110. In some embodiments, the shunt element 120 may include a balloon connected to the shunt element shaft that is positioned within the catheter shaft 118 in a first state (e.g., before and / or during deployment to position the shunt element 120). In certain embodiments, the shunt element shaft has a predetermined curvature. In some examples, the shunt element shaft has a predetermined curvature for deployment of the shunt element. In certain embodiments, the shunt element shaft extends from the catheter shaft 118 in a second state (e.g., a shunt state in which the shunt element is used).

[0036] According to certain embodiments, during deployment, the shunt device 106, including the catheter shaft 118, enters through the patient's CS ostium, located in the patient's right atrium. The shunt device 106 may be oriented within the patient's CS through one or more mechanisms, as described 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 bend to conform to the anatomy of the CS.

[0037] In certain embodiments, the shunt catheter 110 includes an apposition element 124 disposed proximate to the shunt element 120. In some embodiments, the apposition element is disposed within the shaft (e.g., the outer shaft) in the first state. In some embodiments, the apposition element 124 protrudes from the catheter shaft 118 in the first state and / or the second state. In certain embodiments, the apposition element 124 can appose a wall of the cardiovascular system (e.g., anterior or posterior wall of the CS, left atrial wall, right atrial wall, etc.) in the second state to, for example, help position and / or stabilize the shunt element 120. In certain embodiments, the apposition element 124 includes a braided structure. In some embodiments, the apposition element 124 can include a nitinol braid that can be retained within the catheter shaft 118. After deployment and stabilization of the catheter shaft 118, the shunt element 120, including the puncture element, can then be deployed. In some embodiments, the shunt element is configured to deliver energy to a target tissue to create a shunt within the CS of a patient.

[0038] According to some embodiments, various components of the shunt catheter system 104 (e.g., the controller 112) may be implemented on one or more computing devices. The computing devices may include any type of computing device suitable for implementing embodiments of the present disclosure. Examples of computing devices include dedicated or general-purpose computing devices such as workstations, servers, laptops, portable devices, desktops, tablet computers, handheld devices, and general-purpose graphics processing units (GPGPUs), all of which are contemplated within the scope of FIG. 1 with respect to the various components of the shunt catheter system 104.

[0039] In some embodiments, a computing device (e.g., controller 112) includes a bus that directly and / or indirectly couples the following devices: a processor, memory, input / output (I / O) ports, I / O components, and a power supply. Any number of additional components, different components, and / or combinations of components may also be included in a computing device. A bus represents what may be one or more buses (e.g., an address bus, a data bus, or a combination thereof). Similarly, in some embodiments, a computing device may include several processors, several memory components, several I / O ports, several I / O components, and / or several power supplies. Additionally, any number of these components or combinations thereof may be distributed and / or replicated across several computing devices. In some embodiments, various components or portions of components (e.g., controller 112, shunt catheter 110, etc.) may be integrated into a physical device.

[0040] In some embodiments, the shunt catheter system 104 includes one or more memories (not shown). The one or more memories may include computer-readable media in the form of volatile and / or non-volatile memory, transient and / or non-transitory storage media, and may be removable, non-removable, or a combination thereof. Examples of media include random access memory (RAM), read-only memory (ROM), electronically erasable programmable read-only memory (EEPROM), flash memory, optical or holographic media, magnetic cassettes, magnetic tape, magnetic disk storage devices or other magnetic storage devices, data transmission, and / or any other medium that can be used to store information and that can be accessed by a computing device, such as, for example, quantum state memory. In some embodiments, the one or more memories store computer-executable instructions that cause a processor (e.g., controller 90) to implement aspects of embodiments of the system components discussed herein and / or perform aspects of embodiments of the methods and procedures discussed herein.

[0041] Computer-executable instructions may include, for example, computer code, machine-usable instructions, etc., such as, for example, program components that may be executed by one or more processors associated with a computing device. The program components may be programmed using any number of different programming environments, including various languages, development kits, frameworks, etc. Some or all of the functionality contemplated herein may also or alternatively be implemented in hardware and / or firmware.

[0042] In some embodiments, the memory may include a data repository, which may be implemented using any one 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 (ODBMS or OODBMS) database management system, 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 through a data integration process or software application. 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 series of networked computers, servers, or devices. In some cases, the data repository may be hosted on a hierarchy of data storage devices, including local, regional, and central.

[0043] The various components of the shunt catheter system 104 may communicate or be coupled via a communication interface, e.g., a wired interface or a wireless interface. Communication interfaces include, but are not limited to, any wired or wireless short-range and long-range communication interface. A wired interface may use a cable, an umbilical, or the like. A short-range communication interface may be, for example, an interface that conforms to a known communication standard, such as a local area network (LAN), the Bluetooth® standard, an IEEE 802 standard (e.g., IEEE 802.11), ZigBee® or similar specifications, such as those based on the IEEE 802.15.4 standard, or other public or proprietary wireless protocols. A long-range communication interface may be, for example, a wide area network (WAN), a cellular network interface, a satellite communication interface, or the like. A communication interface may be either within a private computer network, such as an intranet, or over a public computer network, such as the Internet. Various modifications and additions may be made to the exemplary embodiments described without departing from the scope of the present invention. For example, while the above embodiments refer to particular features, the scope of this invention includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of this invention is intended to embrace all such alternatives, modifications, and variations that fall within the scope of the claims, together with all equivalents thereof.

[0044] FIG. 2 is a schematic diagram illustrating an example of a shunt device 200 deployed in a patient's heart, according to an embodiment of the present disclosure. FIG. 2 is merely an example. Those skilled in the art will recognize numerous variations, alternatives, and modifications. As shown, the shunt device 200 includes a shunt catheter 202 delivered through the patient's coronary sinus (CS) 210 via a CS ostium 211. In some embodiments, the shunt catheter 202 includes a catheter shaft 204, a shunt element 206, and an apposition element 208. In particular embodiments, 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 shunting state). In particular examples, the shunt element 206 forms an angle greater than 10 degrees from the distal end 205 of the catheter shaft 204. In some instances, the shunt element 206 forms an angle greater than 30 degrees from the distal end 205 of the catheter shaft 204. In some embodiments, the shunt element 206 forms an angle close to 90 degrees from the catheter shaft 204. In some embodiments, the shunt element 206 forms an angle within the range of 10 degrees to 120 degrees from the catheter shaft 204.

[0045] In some embodiments, the catheter shaft 204 is made of a flexible material that can bend with the anatomy of the patient's CS 210. In certain embodiments, for example, the catheter shaft 204 can include polyether block amide, nylon, silicone, or a combination thereof. In some examples, the catheter shaft 204 can be a multi-layered and multi-material component. In some examples, the catheter shaft 204 can be reinforced with braid and / or have an etched or cast liner. The braid for reinforcing the catheter shaft 204 can be made of nitinol. The liner can be made of polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE), a copolymer of polyamide and polyether, or a combination thereof. In some embodiments, the catheter shaft 204 is coated with a hydrophilic coating for lubricity or other types of coatings suitable for coating catheter shafts as known to those skilled in the art.

[0046] In some embodiments, the shunt catheter 202 has a diameter of about 2 mm to about 5 mm. In specific embodiments, the shunt catheter 202 has a diameter of about 2.5 mm to about 4.5 mm. In some embodiments, the shunt catheter has a diameter of about 3 mm to about 4 mm. In specific embodiments, the shunt catheter 202 may have a diameter that allows it to pass through blood vessels and portions of the cardiovascular system to reach a target location.

[0047] 3 is a schematic diagram of a side view of an example shunt device 300 and a perspective view of an apposition element 308 of the shunt device 300, according to an embodiment of the present disclosure. FIG. 3 is merely an example. Those skilled in the art will recognize numerous variations, alternatives, and modifications. As shown, the shunt device 300 includes a shunt catheter 302 that is delivered through the coronary sinus (CS) of a patient. The shunt catheter 302 includes a catheter shaft 304, a shunt element 306, and an apposition element 308.

[0048] According to certain embodiments, 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 with the anatomy of the patient's CS. In certain embodiments, the catheter shaft 304 may include polyether block amide, nylon, silicone, and / or combinations thereof. In some examples, the catheter shaft 304 may be a multi-layered and multi-material component. In some examples, the catheter shaft 304 may be reinforced with braid and have an etched or cast liner. The braid for reinforcing the catheter shaft 304 may be made of nitinol. The liner may be made of polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE), a copolymer of polyamide and polyether, or a combination thereof. In certain embodiments, the catheter shaft 304 may be injection molded or extruded. In some embodiments, the catheter shaft 304 is coated with a hydrophilic coating for lubricity or other type of coating suitable for coating catheter shafts as known to those skilled in the art. In some examples, the catheter shaft 304 may have multiple lumens.

[0049] According to some embodiments, the catheter shaft 304 may include a stabilizing element, such as a distal tip 305, at its distal end 304a, having a curve (e.g., a pre-existing curve), e.g., a curve that matches the anatomy of the patient's CS. In some examples, the distal tip 305 may be made of a different material than the rest of the catheter shaft 304. In some examples, for example, the distal tip 305 may be made of a more flexible material than the material of the rest of the catheter shaft 304. The distal tip 305 may be injection molded or machined with a unique geometry (e.g., a curve) to better stabilize the catheter shaft 304 during deployment.

[0050] According to some embodiments, the distal tip 305 can have a length of about 5 mm to about 85 mm. In certain embodiments, the catheter shaft 304 includes a shaft opening 304c. In some embodiments, the shaft opening 304c and a portion of the catheter shaft from the distal end 304a include 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, deployed state. In certain embodiments, the second axis 309 and the first axis 307 form an angle greater than 0 degrees.

[0051] According to certain embodiments, the shunt element 306 is disposed within the shaft lumen 304b in the first state. In some embodiments, the shunt element 306 includes an expandable element 312, also referred to as a balloon or balloon element, connected to a shunt element shaft 310 at one end and a puncture element 314 (e.g., a needle) at the other end. In certain embodiments, the expandable element 312 is an elongate element. The shunt element 306 may be connected to the shunt element shaft 310, which is positioned within the shaft lumen 304b of the catheter shaft 304 in the first state (e.g., during deployment to position the shunt element 306). In certain embodiments, the shunt element shaft 310 has a predetermined curvature. In some examples, the shunt element shaft 310 has a predetermined curvature for deployment of the shunt element 306. In certain embodiments, the shunt element shaft extends from the shaft lumen 304b of the catheter shaft 304 in the second state (e.g., a shunt state in which the shunt element is used). 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, ultrasound energy, etc.) to the target tissue and is expanded when the shunt element 306 is in the second state.

[0052] According to certain embodiments, the width (w) of the expandable element 312 can range from about 3 mm to about 15 mm. In some embodiments, the width (w) of the expandable element 312 can range from about 3.5 mm to about 12 mm. In certain embodiments, the width (w) of the expandable element 312 can range from about 4 mm to about 10 mm. In some embodiments, the width (w) of the expandable element 312 can range from about 4.5 mm to about 8 mm.

[0053] According to some embodiments, the shunt catheter 302 further includes an outer shaft 316 that is disposed over 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 curve with the anatomy of the patient's CS. In certain embodiments, for example, the outer shaft 316 can include polyether block amide, nylon, silicone, or a combination thereof. In some examples, the outer shaft 316 can be a multi-layered and multi-material component. In some examples, the outer shaft 316 can be reinforced with braid and have an etched or cast liner. The braid for reinforcing the catheter shaft 304 can be made of nitinol. The liner can be made of polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE), a copolymer of polyamide and polyether, or a combination thereof. In certain embodiments, the outer shaft 316 can be injection molded or extruded. In some embodiments, the catheter shaft 304 is coated with a hydrophilic coating for lubricity or other type of coating suitable for coating catheter shafts as known to those skilled in the art.

[0054] According to certain embodiments, the apposition element 308 is disposed within the outer shaft 316 in a first state (e.g., during deployment). In embodiments, the apposition element 308 protrudes from the catheter shaft 304 during deployment. The apposition element 308 is flexible and configured to compress to fit within the outer shaft 316 and decompress to protrude from the catheter shaft 304 during deployment. In some embodiments, the apposition element 308 is disposed proximate the shunt element 306 and / or one or more shaft openings 304c. In some examples, the apposition element 308 is a braided structure including one or more nickel titanium wires. In further examples, the apposition element 308 is made of a flexible material having a portion protruding from the catheter shaft 304. In some examples, the flexible material can be foam. In some examples, the flexible material can be a balloon filled with a contrast solution that appears under fluoroscopy. In further examples, the flexible material can be a polymer with radiopaque markers added for visualization. The radiopaque marker may include tantalum, gold, or any radiopaque marker known to one of ordinary skill in the art.

[0055] In certain embodiments, apposition element 308 is configured to appose at least one wall within the patient's CS or LA, such that shunt catheter 302 is stabilized in one position upon deployment. According to some embodiments, apposition element 308 has several advantages, one of which is stabilization of catheter 302 after deployment. Any movement, or lack thereof, of a protruding element (e.g., braided element 318) provides an estimate of how far catheter 302 is from a tissue wall (e.g., a vascular wall of the patient's CS). Furthermore, when apposition element 308 includes braided element 318, even when element 318 apposes a tissue wall (e.g., a vascular wall of the patient's CS), openings between the braids still allow blood flow through apposition element 308, thus reducing the risk of thrombus formation caused by any blockage within the vessel.

[0056] 4 is a schematic illustration of a cross-sectional view of an example shunt catheter 400, according to an embodiment of the present disclosure. As shown, the shunt catheter 400 includes a catheter shaft 402 having a shaft lumen 404 and a shunt element 406 disposed within the shaft lumen 404 in a first state (e.g., during deployment).

[0057] In some embodiments, the shunt element 406 extends from the catheter shaft 402 in the second state. The shunt element 406 may include an expandable element 412 (e.g., a balloon) connected to the shunt element shaft 410 at one end and a puncture element 414 (e.g., a needle) at the other end. In some examples, the expandable element 412 may be a balloon configured to deliver energy (e.g., ablation energy, radiofrequency (RF) energy, phased RF energy, thermal energy, cryogenic energy, pulsed ablation energy (e.g., pulsed field ablation (PFA)), microwave energy, laser energy, ultrasound energy, etc.) to the target tissue. In some embodiments, the shunt element 406 is positioned within the catheter shaft 402 in the first state (e.g., during deployment to position the shunt element 406). In certain embodiments, the shunt element shaft 410 has a predetermined curvature. In some examples, the shunt element shaft 410 has a predetermined curvature for deployment of the shunt element 406. In certain embodiments, a shunt element shaft 410 extends from the catheter shaft 402 in a second state (eg, a shunt state, a shunt state using a shunt element).

[0058] 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 the shunt element 406 defines a second axis 409. In certain embodiments, the expandable element 412 is an elongated element having a length along the second axis 409 that is greater than its width perpendicular to the second axis 409. In certain embodiments, the second axis 409 and the first axis 407 form an angle greater than 0 degrees. In certain instances, 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 within a range of 30 degrees to 120 degrees. In some examples, the catheter shaft 402 includes a pre-curve formed from a semi-rigid or rigid material connected to the piercing element 414. The semi-rigid or rigid material may include nitinol or stainless steel (SS) with a curve built into it prior to deployment.

[0059] In some embodiments, the shunt element shaft 410 includes a curved portion 410b that forms an arc connecting a first straight portion 410a of the shunt element shaft that is disposed inside the shaft lumen 404 and a second straight portion 410c of the shunt element shaft that extends outward from the shaft lumen 404. In embodiments, for example as shown, the curved portion 410b of the shunt element shaft 410 is adjacent the shaft opening 402c. In certain embodiments, the expandable element 412 is located in the second straight portion 410c and outside the curved portion 410b of the shunt element shaft 410. In some embodiments, the expandable element 412 is an elongate element.

[0060] According to certain embodiments, the shunt catheter 400 may further include an outer shaft 416 disposed outside the catheter shaft 402 and surrounding the catheter shaft 402, the apposition element 418 in a compressed pre-shunt state, and the shunt element 406. The outer shaft 416 may have a diameter of about 2.7 to about 6.0 mm (about 8 to about 18 French), or about 2.8 to about 5.3 mm (about 8.5 to about 16 French), or about 3.0 to about 4.7 mm (about 9 to about 14 French), or about 3.2 to about 4.0 mm (about 9.5 to about 12 French), or may have a diameter within these ranges. In some embodiments, for example, during deployment, the outer shaft 416 is pulled back to deploy and / or position the catheter shaft 402, including the apposition element 418 and shunt element 406.

[0061] In certain embodiments, the shunt catheter 400 includes multiple compartments (e.g., lumens) for various elements to provide greater target 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 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 deployment of the apposition element 418. In some embodiments, the shunt catheter 400 may include lumens to accommodate functional components such as a guidewire or pullwire assembly, as described further below. Furthermore, in some embodiments, the shunt catheter 400 may include an additional lumen to retain shunted tissue from the tissue wall.

[0062] 5A-5C are schematic diagrams of an example shunt catheter 500 according to an embodiment of the present disclosure. As shown, the shunt catheter 500 includes a catheter shaft 502 having a shaft opening 502a, a shaft lumen 504, and a shunt element 506 disposed within the shaft lumen 504 in a first state.

[0063] In some embodiments, the shunt element 506 extends from the catheter shaft 502 in the second state, as shown in, for example, FIGS. 5A-5C. In embodiments, the shunt element 506 includes balloon elements 512a-512c connected to a balloon shaft 510. In certain embodiments, the balloon shaft is disposed within the shaft lumen 504 in the first state and extends from the catheter shaft 502 in the second state. In certain embodiments, the balloon shaft 510 has a predetermined curvature for deployment of the shunt element 506. The balloon shaft 510 may further be connected to a puncture element 514 (e.g., a needle). In some examples, the balloon elements 512a-512c are configured to deliver energy (e.g., ablation energy, radiofrequency (RF) energy, phased RF energy, thermal energy, cryogenic energy, pulsed ablation energy (e.g., pulsed field ablation (PFA)), microwave energy, laser energy, ultrasound energy, etc.) to treat surrounding tissue.

[0064] In certain embodiments, the balloon elements 512a-512c are made of a material including nylon, a copolymer of polyamide and polyether, polyethylene terephthalate (PET), polyurethane (PU), silicone, thermoplastic polyurethane, polyamide, or a combination thereof. In some examples, the balloon elements 512a-512c are multi-layered. In certain examples, the balloon elements 512a-512c are disposed on the balloon shaft 510 and are expandable in the second state of the shunt element 506 during deployment. In some embodiments, the balloon elements 512a-512c include at least one electrode of one or more electrodes disposed on the balloon elements 512a-512c.

[0065] According to some embodiments, balloon elements 512a-512c are disposed at the distal end 510a of balloon shaft 510 and include multiple states during deployment. In certain embodiments, balloon elements 512a-512c include at least two states (e.g., a deployed state, an actuated state, etc.). In some embodiments, balloon elements 512a-512c include three or more states. In some embodiments, balloon element 512a is in a compressed state, for example, as shown in FIG. 5A . In some examples, balloon element 512a is crimped when in the compressed state. In certain examples, balloon element 512a includes multiple layers when in the compressed state. In some examples, balloon element 512a may be made of a relatively thick and / or rigid material and may be folded into pleats when in the compressed state. In certain examples, balloon element 512a may be made of a relatively thin and / or flexible material and may include one layer when in the compressed state. In some embodiments, balloon element 512b is expanded to a first inflation state (e.g., a semi-inflated state), as shown in Figure 5B, and in some embodiments, balloon element 512c is expanded to a second inflation state (e.g., a fully inflated state), as shown in Figure 5C.

[0066] According to certain embodiments, the catheter shaft 502 defines a first axis 507, and the balloon shaft 510 defines a second axis 509. In certain embodiments, the second axis 509 and the first axis 507 form an angle greater than 0 degrees. In certain examples, the second axis 509 and the first axis 507 form an angle greater than 20 degrees. In certain examples, 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 certain examples, the second axis 509 and the first axis 507 form an angle close to 90 degrees.

[0067] According to some embodiments, the balloon element 512a, when in a compressed state, has a balloon length (L a ) and the balloon width (W a The balloon length La may be about 4 mm to about 20 mm. The balloon width W a can be from about 1 mm to about 5 mm. In some examples, the balloon element 512a is in a compressed state in the first state (e.g., during deployment) of the shunt element 506. In some examples, the balloon element 512a is in a compressed state when the puncture element 514 is used to penetrate and puncture a tissue wall. In certain examples, the balloon element 512a is in a compressed state such that the width of the balloon element 512a is less than the diameter of the patient's blood vessel (e.g., the coronary sinus).

[0068] According to certain embodiments, balloon element 512b, when in the first inflated state, has a balloon length (L b ) and the balloon width (W b In some embodiments, the length (L) of the balloon 512b when the balloon element is in an inflated state b ) is the width (W b ) is larger than the length (L b ) is the length (L a ) in a semi-inflated state. In certain embodiments, the width (W b ) can be in the range of about 1 mm to about 12 mm, or about 1 mm to about 10 mm, or about 2 mm to about 10 mm, or about 2 mm to about 9 mm, or about 2 mm to about 8 mm, or about 2 mm to about 7 mm, or about 2 mm to about 6 mm, or ranges subsumed within these ranges. In certain examples, balloon element 512b is in a first expanded state and is configured to treat surrounding tissue by delivering energy or a chemical to the surrounding tissue.

[0069] According to some embodiments, balloon element 512c, when in the second inflated state, has a balloon length (L c ) and the balloon width (W c In some embodiments, when the balloon element is in the second inflated state, the length (L c ) is the width (W c ) is larger than the length of the balloon 512c (L c ) is the length (L b ) can be the same as or comparable to the width (W ) of the balloon 512c. In some examples, for example, as shown in FIG. 5C, the balloon element 512c is expanded to a second inflated state (e.g., a fully inflated state). In some embodiments, the balloon element 512c is an elongated element. In certain embodiments, the width (W ) of the balloon 512c can be c ) can be in the range of about 3 mm to about 15 mm, or about 3 mm to about 12 mm, or about 3.5 mm to about 12 mm, or about 4 mm to about 10 mm, or about 4.5 mm to about 10 mm, or about 5 mm to about 10 mm, or about 5 mm to about 8 mm, or any range subsumed within these ranges. In certain examples, balloon element 512c is in a second inflated state (e.g., a fully inflated state) and is configured to treat surrounding tissue by delivering energy or a chemical agent to the surrounding tissue.

[0070] In some embodiments, the balloon elements 512b, 512c are expanded to the expanded state in the second state (e.g., during shunting) of the shunt element 506. In some examples, the balloon element 512a is expanded from the compressed state to the expanded state after the puncturing element 514 penetrates and punctures the tissue wall.

[0071] In some examples, after balloon element 512a is expanded 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.) may be delivered to one or more electrodes disposed on balloon element 512b or 512c to ablate tissue surrounding balloon element 512b or 512c.

[0072] 6A-6C are schematic diagrams of perspective views of an example shunt element 600, according to an embodiment of the present disclosure. As shown, the shunt element 600 includes balloon elements 612a-612c disposed at 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 comparable to one another. In some embodiments, the balloon widths W1, W2, and W3 are different from one another.

[0073] According to certain embodiments, balloon elements 612a-612c include membranes made of materials including nylon, polyamide and polyether copolymer, polyethylene terephthalate (PET), polyurethane (PU), silicone, thermoplastic polyurethane, polyamide, or combinations thereof.

[0074] According to some embodiments, balloon elements 612a-612c include multiple states. In certain embodiments, balloon elements 612a-612c include three or more states. In some embodiments, balloon element 612a is in a crimped, compressed state, as shown in FIG. 6A for example. In some embodiments, balloon element 612b is expanded to a first expanded state (e.g., a semi-inflated state), as shown in FIG. 6B for example. In yet some embodiments, balloon element 612c is expanded to a second expanded state (e.g., a fully inflated state), as shown in FIG. 6C for example.

[0075] In certain embodiments, balloon element 612a has a length (L1) of about 4 mm to about 20 mm and a width (W1) of about 1 mm to about 5 mm. In some examples, for example, as shown in FIG. 6A, balloon element 612a is in a compressed state having a pleated configuration, where balloon element 612a is crimped into one or more flat pieces (e.g., one or more pleats 614a) folded over one another. In some examples, each pleat of one or more pleats 614a can be the same size and thickness.

[0076] In some embodiments, the balloon element 612b has a length (L2) of about 4 mm to about 20 mm and a width (W2) of about 1 mm to about 5 mm. The length (L2) of the balloon 612b can be the same as or comparable to the length (L1) of the balloon 612a. In some examples, for example, as shown in FIG. 6B, the balloon element 612b is expanded to a first inflated state (e.g., a semi-inflated state). In certain examples, when the balloon element is in the first inflated state, the length (L2) of the balloon 612b is greater than the width (W2) of the balloon 612b. Each of the one or more pleats 614b of the balloon element 612b expands in thickness, and the outer edge, e.g., outer edge 616, of each pleat 614b may have an average distance of about 1 mm to about 5 mm to the axis 618 defined by the balloon shaft 610. In certain examples, balloon element 612b is in a first expanded state and is configured to treat surrounding tissue by delivering energy or chemicals to the surrounding tissue.

[0077] In certain embodiments, balloon element 612c has a length (L3) of about 4 mm to about 20 mm. The length (L3) of balloon element 612c can be the same as or similar to the length (L1) of balloon element 612a and the length (L2) of balloon element 612b. In some examples, balloon element 612c is expanded to a second inflated state (e.g., a fully inflated state), as shown in FIG. 6C . In some embodiments, balloon element 612c is an elongate element. In certain examples, when the balloon element is in the second inflated state, the length (L3) of balloon 612c is greater than the width (W3) of balloon 612c.

[0078] As shown, balloon element 612c is fully expanded and no longer has a pleated configuration. In some examples, the width (W3) of balloon 512c can be in the range of about 3 mm to about 15 mm, or about 3 mm to about 12 mm, or about 3.5 mm to about 12 mm, or about 4 mm to about 10 mm, or about 4.5 mm to about 10 mm, or about 5 mm to about 10 mm, or about 5 mm to about 8 mm, or ranges subsumed within these ranges. In certain examples, balloon element 612c is in the second expanded state and is configured to treat surrounding tissue by delivering energy or a chemical agent to the surrounding tissue.

[0079] FIG. 7 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 pierced through a tissue wall 720 (e.g., a blood vessel wall of a patient's CS). The shunt element 706 includes a balloon element 712 and a puncture element 714 disposed at the distal end 710a of a balloon shaft 710. In some embodiments, the balloon element 712 is expanded and in an inflated state, as shown in FIG. 7 . In certain embodiments, the balloon element 712 includes one or more electrodes 713 disposed on an outer surface of the balloon element 712 where the balloon element 712 contacts the wall 720.

[0080] In some embodiments, the shunt element 706 includes a tube 716 (e.g., a hypotube) for supporting the balloon element 712. The tube 716 may include a plurality of laser cuts 718 that are generally perpendicular to an axis 709 defined by the shunt element 706. In some examples, the axis 709 is perpendicular to the wall 720. In some examples, the axis 709 is at an angle of about 80 to about 100 degrees relative to the wall 710.

[0081] In some examples, the tube 716 is made of a semi-rigid or rigid material (e.g., stainless steel or nitinol) and may further include a pull wire assembly (not shown) to control the bending or angle of the puncture element 714 relative to the wall 720. Because the balloon element 712 is made of an expandable, and therefore relatively flexible, material, the tube 716, made of a relatively more rigid material and centrally located on the balloon element 712 along the axis 709, helps support the shunt element 706 as the puncture element 714 penetrates and punctures the wall 720. The multiple laser cuts 718 allow the tube 716 to bend in a particular direction while maintaining the rigidity of the shunt element 706 along the axis 709. In some embodiments, the balloon shaft 710 has a preformed curve 722 that includes a radius 724 when deployed.

[0082] In certain embodiments, the shunt catheter 700 further includes a lumen 728 disposed outside and surrounding the balloon shaft 710. The lumen 728 may also be disposed within the catheter shaft (e.g., catheter shaft 502 in FIGS. 5A-5B). In some examples, the lumen 728 is configured to control the expansion of the balloon element 712. In some examples, the balloon element 712 is in a compressed state during deployment (e.g., the compressed state shown in FIGS. 5A and 6A). After the wall 720 is punctured using the needle element 714, the lumen 728 is retracted so that the balloon element 712 may then be inflated using an inflation source (e.g., inflation source 122 in FIG. 1) or manually by a user based on the desired volume or pressure for the shunt.

[0083] In some examples, the balloon element 712 has a variable size based on its internal pressure after inflation. In some examples, the balloon element 712 has a variable volume based on its internal pressure after inflation. In certain examples, for example, during shunting, various sizes of shunts can be created using a single balloon. In certain embodiments, based on the needs of the physician or patient, balloon elements having variable sizes and / or volumes can be used to create shunts having diameters of about 3 mm to about 15 mm, or about 3 mm to about 12 mm, or about 3.5 mm to about 12 mm, or about 4 mm to about 10 mm, or about 4.5 mm to about 10 mm, or about 4.5 mm to about 8 mm, or about 4.5 mm to about 6 mm, or diameters falling within these ranges. In some examples, balloon elements can be used to create shunts having a diameter of about 5 mm.

[0084] In some embodiments, the shunt catheter 700 includes multiple compartments (e.g., lumens) for various elements to provide greater target control during deployment. For example, in addition to the lumen 728, the shunt catheter 700 may include one or more additional lumens for separately accommodating functional components such as a guidewire or pullwire assembly. In some examples, the shunt catheter 700 may include an additional lumen for retaining the shunted tissue from the tissue wall.

[0085] 8A-8D are schematic diagrams of example balloon elements 800a-800d, according to embodiments of the present disclosure. As shown in FIG. 8A, balloon element 800a is in an inflated state including a first section 802a in the center of balloon element 800a. In embodiments, the balloon element includes a second section 804 at a distal end 806 of balloon element 800a and a third section 808 at a proximal end 810 of balloon element 800a. In some embodiments, distal end 806 of balloon element 800a is connected to a piercing element 812, and proximal end 810 of balloon element 800a is connected to a balloon shaft 814.

[0086] In some embodiments, for example as shown, first section 802a is between second section 804 and third section 808. In some examples, first section 802a is a narrow section having a diameter smaller than the diameter of second section 804 or the diameter of third section 808.

[0087] In certain embodiments, the balloon element 800a has a length (l) of about 4 mm to about 20 mm. a ) and a width that varies along the length of the balloon element 800a. In some examples, the width (w 1a ) is about 5 mm to about 15 mm, and the width (w 2a ) is about 5 mm to about 15 mm, and the second section 804 and the third section 808 have the same or similar width.1a vs. w 2a The ratio may be about 1:5 to 3:5. In some embodiments, balloon elements having a larger width may be used to create a larger opening. In certain embodiments, balloon elements having variable sizes and / or volumes may be used to create shunts of various sizes between the patient's coronary sinus and left atrium. In some instances, balloon elements having a larger width may be used to create relatively larger shunts, and therefore, a larger pressure drop may occur in the patient's left atrium as a result of creating the shunt.

[0088] The balloon geometry shown in FIG. 8A may be referred to as a waisted geometry, having a narrow section 802a sandwiched between two thicker sections. In some embodiments, the first section 802a (e.g., the narrow section) of the balloon element 800a may be referred to as a "seating region," intended to host, for example, the wall of the cardiovascular system. In certain embodiments, for example, during ablation, the first section 802a of the balloon element 800a directly contacts the wall of the patient's blood vessel, such that the tissue wall surrounds the "seating region" of the balloon 800a. In some examples, the narrow section (e.g., the first section 802a) may not be at the center of the balloon element 800a, but may be closer to the distal end 806 or proximal end 810 of the balloon element 800a. In certain examples, the axis 816a passes through the center point of the balloon 800a and is perpendicular to the balloon shaft 814. The first axis 816a is located generally at the center of the first section 802a of the balloon element 800a. The second axis 818a is defined by the transition between the first section 802a and the second section 804. As shown, the second axis 818a and the first axis 816a form an angle (e.g., a takeoff angle) of about 60 degrees to about 85 degrees.

[0089] According to some embodiments, the waisted balloon configuration includes several advantages. For example, during deployment and after expanding the balloon element 800a, the position of the balloon element 800a can be further adjusted based on the position of the first section 802 (e.g., the narrow section) relative to the tissue wall (e.g., the patient's blood vessel wall). In some examples, during shunting, the tissue wall surrounds and directly contacts the narrow section of the balloon element 800a, and thus can help stabilize and keep the balloon element 800a in place during shunting.

[0090] As shown in FIG. 8B, balloon element 800b is in an inflated state and has a similar waisted geometry to balloon element 800a. In some embodiments, first section 802b is located in the center of balloon element 800b. Additionally, in some embodiments, the first section (e.g., the narrow section) is closer to the proximal end 810 or the distal end 806 of balloon element 800b. In certain examples, axis 816b passes through the center point of balloon 800b and is perpendicular to the balloon shaft. First axis 816b is located approximately in the center of first section 802b of balloon element 800b. Second axis 818b is defined by the transition between first section 802b and second section 804. As shown, second axis 818b and first axis 816b form an angle (e.g., a takeoff angle) of about 15 degrees to about 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 may aid in seating of the balloon 800a-800b on the wall of the patient's blood vessel.

[0091] In certain embodiments, the balloon element 800b has a length (l) of about 4 mm to about 20 mm. b ) and a width that varies along the length of balloon element 800b. In some embodiments, first section 802b has a width (w1b ), while the width (w 2b ) is about 4 mm to about 15 mm, and second section 804 and third section 808 have the same or similar width. 1b No w 2b The quotient for w 1a No w 2a is smaller than the quotient for w 1b vs. w 2b The ratio can be from about 1:5 to about 3:5.

[0092] 8C, balloon element 800c is in an inflated state including a first section 802c in the center of balloon element 800c. In embodiments, balloon element 800c includes a second section 804c at a distal end 806 of balloon element 800c and a third section 808c at a proximal end 810 of balloon element 800c. In some embodiments, for example, as shown, sections 802c, 804c, and 808c each include a straight portion with a constant width, while the sections of balloon element 800a or 800b are of a constantly varying width.

[0093] The balloon geometry shown in Figure 8C may be referred to as a dogbone geometry. In embodiments, along the length of balloon element 800c, first section 802c has a length (l) of about 0.5 mm to about 15 mm. 1c ) and the second section 804c has a straight portion having a length (l) of about 4 mm to about 10 mm. 2c ) and the third section 808c has a straight portion having a length (l) of about 1 mm to about 10 mm. 3c In some examples, the first section 802c is the "seating area" of the balloon element 800c and may have a length approximately equal to the thickness of the wall of the patient's blood vessel. In certain examples, the length (l 1c) is about 0.5 mm to about 4 mm. The length of each of the straight portions of sections 802c, 804c, and 808c may be the same or different. In some embodiments, first section 802c has a smaller width compared to the width of second section 804c. In some embodiments, second section 804c has a smaller width compared to the width of third section 808c.

[0094] 8D, balloon element 800d is in an inflated state including a first section 802d in the center of balloon element 800d. In embodiments, balloon element 800d includes a second section 804d at a distal end 806 of balloon element 800d and a third section 808d at a proximal end 810 of balloon element 800d. In some embodiments, for example as shown, sections 802d, 804d, and 808d each include a straight portion with a constant width, while the sections of balloon element 800a or 800b are of a constantly varying width.

[0095] The balloon geometry as shown in FIG. 8D may be referred to as a stepped geometry. In an embodiment, the first section 802d has a width (w 1d ) and the second section 804d has a width (w 2d ) and the third section 808d has a width (w 3d In some embodiments, second section 804d is further connected to piercing element 812 and has the smallest width of the three sections. In some embodiments, first section 802d has a width that is greater than the width of second section 804d but less than the width of third section 808d.

[0096] In certain embodiments, one or more electrodes 820 are disposed on the exterior surface of the balloon 800d surrounding the first section 802d. In certain embodiments, for example, during shunting, the electrodes 820 on the first section 802d are configured to deliver energy to ablate tissue surrounding the first section 802d. In some embodiments, having the third section 808d with a greater width than the second section 802d creates a backstop to provide better control of the position and / or movement of the tissue wall along the length of the balloon 800d, thus increasing the stability of the balloon 800d during shunting.

[0097] It should be understood that the balloon geometries shown in Figures 8A-8D are merely examples, and that balloons of other shapes or geometries may be used as part of the shunt element of a shunt catheter. In some embodiments, for example, the balloon element may be conical, spherical, conical-to-elongated square, spheroid, offset (e.g., a partially inflated balloon), square, conical-to-square, conical-to-spheroid, tapered, or conical-to-offset. In certain embodiments, the balloon element is symmetrical along the length of the balloon shaft. In even more specific embodiments, such as with an offset shape, the balloon element is asymmetrical along the length of the balloon shaft.

[0098] 9A-9D are example cross-sectional views 900a-900d of balloon elements according to embodiments of the present disclosure. In some embodiments, the balloon elements have a cross-sectional shape perpendicular to the balloon element shaft, and the cross-sectional shape is circular, oval, or substantially square or rectangular with rounded corners. In certain embodiments, different cross-sectional shapes of the balloon elements when shunted result in different shapes of the shunt. Thus, the geometry of the shunt can be the same as or similar to the cross-sectional shape of the balloon elements. In some examples, the cross-section of the balloon elements has an asymmetric cross-sectional shape (e.g., an offset-shaped balloon) configured to create an asymmetric shunt.

[0099] According to some embodiments, the cross section 900a of the balloon element is circular in shape, as shown, for example, in Figure 9A. According to certain embodiments, the cross section 900b of the balloon element is oval in shape, as shown, for example, in Figure 9B. In some embodiments, the cross section 900c of the balloon element is substantially square in shape with one or more rounded corners 902, as shown, for example, in Figure 9C. In certain embodiments, the cross section 900d of the balloon element is substantially rectangular in shape with one or more rounded corners 904, as shown, for example, in Figure 9D.

[0100] In some embodiments, balloon elements having a non-circular cross-sectional shape may have one or more advantages for ablation. For example, balloon elements having an oval or rectangular cross-sectional shape may help provide sufficient area for blood flow within the size of a vessel (e.g., a patient's CS). In some instances, balloon elements having an oval or rectangular cross-sectional shape provide flexibility with respect to creating shunts of desired shapes and / or diameters. For example, shunts aligned with the flow direction of the vessel may be created in a patient's vessels having a smaller width by using balloon elements having an oval cross-sectional shape.

[0101] 10A-10I are schematic diagrams of example electrode configurations disposed on a balloon element 1000a, according to certain embodiments of the present disclosure. As shown in FIG. 10A, the balloon element 1000a has a spheroidal shape, and a film 1002a is disposed on the outer surface of the balloon element 1000a. One or more electrodes may be disposed on the film 1002a before the film 1002a is disposed on the balloon element 1000a. In some embodiments, the electrodes are disposed on the surface of the balloon element 1000a before being covered by the film 1002a. In certain embodiments, the electrodes are configured to deliver energy to surrounding tissue and may include platinized titanium anodes, platinum wire, iridium wire, nitinol, stainless steel, cobalt chrome, gold, copper, metal encapsulated in a silicone sheet, or combinations thereof.

[0102] As shown in Figures 10B-10D, one or more electrodes 1004b-1004d have various configurations. In some embodiments, electrode 1004b is a line pattern, as shown in Figure 10B for example. In some embodiments, electrode 1004c is a grid pattern, as shown in Figure 10C for example. In some embodiments, electrode 1004d is a curved form, as shown in Figure 10D for example. In certain embodiments, the grid pattern of electrode 1004c and the curve of electrode 1004d may reduce electrode strain during shunting. In some embodiments, the grid pattern of electrode 1004c and the curve of electrode 1004d may reduce electrode strain during crimping of balloon element 1000a.

[0103] As shown in Figures 10E-10H, electrodes 1004e-1004h are individually and directly disposed on the surface of balloon elements 1000e-1000h without a film. In some embodiments, for example, as shown in Figure 10E, electrode 1004e is disposed directly on the surface of balloon element 1000e, which has a rectilinear shape. In some embodiments, for example, as shown in Figure 10F, electrode 1004f is disposed directly on the surface of balloon element 1000f and further 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, for example, as shown in Figure 10G, electrode 1004g has a curved pattern. In some examples, when electrodes are formed in a curved pattern, the effect of any potential deformation of the shape of balloon element 1000g can be reduced by reducing the strength of the electric field surrounding balloon element 1000g and potential changes in shape.

[0104] According to certain embodiments, for example as shown in Figure 10H, the balloon element 1000h includes a central narrow section 1006h surrounded by sections 1008h and 1010h on the two ends of the balloon element 1000h. In certain embodiments, the balloon element 1000h further includes an electrode 1004h having a straight section 1012h and curved sections 1014h and 1016h at the two ends of the balloon element 1000h.

[0105] According to certain embodiments, as shown in FIG. 10I, for example, the balloon element 1000i includes electrodes 1004i. While only four electrodes 1004i are shown in the example of FIG. 10I, any number of electrodes 1004i may be disposed on the balloon element 1000i. In certain examples, the balloon element 1000i may include six, eight, or ten electrodes 1004i. In some embodiments, one or more of the electrodes 1004i have a central longitudinal portion 1020i and a plurality of protrusions 1022i extending from the central portion 1020i. In certain embodiments, at least some of the protrusions 1022i are orthogonal to the central longitudinal portion 1020i. In certain embodiments, at least some of the protrusions 1022i are parallel to one another. In some examples, each of the protrusions 1022i is parallel to one another.

[0106] According to certain embodiments, for example, as shown in FIG. 10I , the electrode 1004i can include a portion 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 are surrounded by the non-conductive material 1024i. Heat can be conducted along the edges of the electrode 1004i near the non-conductive material 1024i. In certain examples, the non-conductive material 1024i extends toward the central portion 1020i. Thus, heat can be generated not only at the edges of the electrode 1004i farthest from the central portion 1020i, but also along the edges of the plurality of protrusions 1022i between each of the plurality of protrusions 1022i. This can enable the electrode 1004i to perform more uniform tissue ablation.

[0107] FIG. 11 is a flow diagram illustrating a process 1100 for creating a shunt in a patient according to an embodiment of the present disclosure. Aspects of an embodiment of process 1100 may be performed, for example, by a shunt catheter system or controller (e.g., system 104 of FIG. 1 , controller 112 of FIG. 1 ). One or more steps of process 1100 are optional and / or may be modified by one or more steps of other embodiments described herein. Additionally, one or more steps of other embodiments described herein may be added to method 1100. In some embodiments, the shunt may be formed in the patient's coronary sinus. In certain embodiments, the shunt includes an opening between the patient's coronary sinus and the left atrium.

[0108] In 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 a shaft lumen, a shunt element having a proximal end and a distal end, and a puncture element disposed proximate the distal end of the shunt element. In some embodiments, the shunt element is disposed within the shaft lumen in the first state. In certain embodiments, the catheter shaft has a shaft opening, and the shunt element extends from the catheter shaft through the shaft opening. In certain embodiments, deploying the shunt catheter includes inserting the shunt catheter into the patient's coronary sinus through the patient's superior vena cava. In certain embodiments, deploying the shunt catheter includes inserting the shunt catheter into the patient's coronary sinus through the patient's inferior vena cava.

[0109] In step 1104, process 1100 includes positioning a shunt catheter near a target location in a patient. In step 1106, process 1100 includes manipulating the shunt catheter to a second state, e.g., wherein the shunt element extends from the catheter shaft at an angle greater than 0 degrees at a proximal end of the shunt element in the second state. In some embodiments, the shunt catheter includes an apposition element disposed proximate to the shunt element, the apposition element protruding from the catheter shaft in the second state. In certain embodiments, the catheter shaft has a shaft opening, and the shunt element extends from the catheter shaft through the shaft opening.

[0110] In step 1108, the process 1100 may include determining the location of the shunt element using an imaging device. In some embodiments, the imaging device includes one or more visualization elements positioned proximate to the shunt element.

[0111] At step 1110, process 1100 includes puncturing an opening at a target location using a puncture element. In some embodiments, the target location is in the patient's coronary sinus. At 1112, process 1100 includes dilating the opening using an expandable element (e.g., expandable element 312 of FIG. 3).

[0112] In step 1114, the process 1100 includes treating tissue surrounding the opening (e.g., by ablating, displacing, cauterizing, or shrinking tissue) using the expandable element in a first or second expanded 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 expanded state, and a second expanded state. In some examples, the balloon is expanded in the second state and configured to deliver energy (e.g., ablation energy, radiofrequency (RF) energy, phased RF energy, thermal energy, cryogenic energy, pulsed ablation energy (e.g., pulsed field ablation (PFA)), microwave energy, laser energy, ultrasound energy, etc.) to the tissue surrounding the opening.

[0113] In 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 may include removing the catheter shaft, the puncture element, and the shunt element. In certain embodiments, process 1100 does not leave any implant device at the target location. In some embodiments, the shunt is created by creating an opening between the patient's coronary sinus and the left atrium. In certain embodiments, the shunt catheter is removed from the patient's coronary sinus. In certain embodiments, the created shunt is an opening that does not include an implant (e.g., a frame or structure to support the opening). In some embodiments, the shunt consists of an opening between the patient's coronary sinus and the left atrium, and the shunt does not include an implant.

[0114] According to some embodiments, the process 1100 includes creating a shunt using a shunt element of a shunt catheter. In certain embodiments, the shunt includes an enlarged opening between the patient's coronary sinus and left atrium. In some embodiments, the shunt does not include any implants.

[0115] 12 is a schematic illustration of a perspective view of an example 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 certain embodiments, the balloon element 1212 includes a membrane made of a material including nylon, a copolymer of polyamide and polyether, polyethylene terephthalate (PET), polyurethane (PU), silicone, thermoplastic polyurethane, polyamide, or a combination thereof.

[0116] According to some embodiments, the balloon element 1212 includes multiple states. In some embodiments, for example, as shown in FIG. 12 , the balloon element 1212 is in a crimped, compressed state. In some examples, for example, as shown in FIG. 12 , the balloon element 1212 is in a compressed state having a pleated configuration, where the balloon element 1212 is crimped into one or more flat pieces (e.g., one or more pleats 1214) folded over one another. In some examples, each pleat of the one or more pleats 1214 can be the same size and thickness. In some examples, each pleat of the one or more pleats 1214 can include one or more pleat surfaces 1216. In some examples, each pleat of the one or more pleats 1214 may include a first pleat surface 1216a on a first side of the pleat and a second pleat surface 1216b on a second side of the pleat, the second side being opposite the first side.

[0117] In some embodiments, an electrode of the plurality of electrodes 1204 is disposed entirely on a pleat surface on one side of one of the one or more pleats 1214. This reduces the potential for the electrode to bend or fold while attached to the balloon element 1212 in a compressed state, which may reduce the potential for damage to the electrode 1204. In some examples, an electrode of the plurality of electrodes 1204 disposed entirely on a pleat surface is disposed on an outer surface of one of the one or more pleats 1214. For example, the electrode may be disposed on a surface of one of the pleats facing outward from the balloon shaft 1210. In some examples, an electrode of the plurality of electrodes 1204 disposed entirely on a pleat surface is disposed on a surface of one of the one or more pleats 1214 facing toward the balloon shaft 1210.

[0118] In some embodiments, several electrodes 1204 may be disposed entirely on several pleat surfaces 1216 of one or more pleats 1214, respectively. In some examples, at least one electrode of the plurality of electrodes 1204 is disposed entirely on each of the one or more pleats 1214 (e.g., disposed on a pleat surface of one or more pleats 1214). In some examples, each or a portion of one or more electrodes of the plurality of electrodes 1204 is disposed entirely on the pleat surface of each of the one or more pleat surfaces 1216.

[0119] FIG. 13 is a schematic diagram of an exemplary expandable element (e.g., balloon element 1300) according to an embodiment of the present disclosure. The balloon element 1300 includes an anchor component 1332 and a shunt component 1330. In certain embodiments, the balloon element 1300 further includes one or more electrodes 1304 disposed on the shunt component 1330. Although only five electrodes 1304 are shown in the example of FIG. 13, any number of electrodes 1304 may be disposed on the shunt component 1330. In some examples, the one or more electrodes 1304 extend along the longitudinal length (L ) of the shunt component 1330. 1330 ) and a longitudinal length (L 1304 In certain examples, the one or more electrodes 1304 may extend along the longitudinal length L of the shunt component 1330. 1330 A longitudinal length slightly shorter than L 1304 In some examples, the longitudinal length L of one or more electrodes 1304 1304 can be in the range of about 70% to about 100%, or about 80% to about 100%, or about 90% to about 100% of the longitudinal length L1330 of the shunt component 1330.

[0120] In some embodiments, one or more electrodes 1304 have a central longitudinal portion 1320 and a plurality of protrusions 1322 extending from the central portion 1320. In certain embodiments, at least some of the plurality of protrusions 1322 are orthogonal to the central longitudinal portion 1320. In certain embodiments, at least some of the plurality of protrusions 1322 are parallel to one another. In some examples, each of the plurality of protrusions 1322 is parallel to one another.

[0121] 13 , one or more electrodes 1304 may be surrounded by a non-conductive material 1324 (e.g., an electrode backing) that includes portions of non-conductive material between each of the plurality of protrusions 1322. Heat may be generated along the edges of the electrode 1304 near the non-conductive material 1324. Because the non-conductive material 1324 extends toward the central portion 1320, heat may be generated not only at the edges of the electrode 1304 farthest 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 may enable the electrode 1304 to perform more uniform tissue ablation.

[0122] In some examples, the balloon element 1300 is in a compressed state in a first state of the shunt element (e.g., during deployment). In some examples, the balloon element 1300 is in a compressed state when the puncturing element is used to penetrate and puncture a tissue wall. In some embodiments, the balloon element 1300 is expanded to an expanded state in a second state of the shunt element (e.g., during shunting). In some examples, the balloon element 1300 is expanded from the compressed state to the expanded state after the puncturing element has penetrated and punctured a tissue wall.

[0123] In some embodiments, the balloon element 1300 can be expanded to a first expanded state, for example, where the anchor component 1332 is expanded and the shunt component 1330 is deflated (e.g., not expanded). In some embodiments, for example, as shown in FIG. 13 , the balloon element 1300 can be expanded to a second expanded state (e.g., a fully expanded state), for example, where both the anchor component 1332 and the shunt component 1330 are expanded. In some embodiments, when the balloon element 1300 is fully expanded (e.g., in the second expanded state), the anchor component 1332 has a first diameter and the shunt component 1330 has a second diameter, the first diameter being larger than the second diameter. In some examples, the first diameter of the anchor component 1332 can be in a range of 4 millimeters to 16 millimeters in the first expanded state. In some examples, the anchor component 1332 has a diameter in a range of 4 millimeters to 20 millimeters in the second expanded state. In some examples, the difference between the diameter of the anchor component 1332 (e.g., the first diameter) and the diameter of the shunt component 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.

[0124] In some embodiments, the anchor component 1332 is configured to facilitate placement of the balloon element 1300 within the patient (e.g., at a target location in a blood vessel or anatomical structure). In some embodiments, the balloon element 1300 is expanded from a compressed state to an expanded state (a first expanded state and / or a second expanded state) after the puncture element penetrates and punctures a tissue wall (e.g., a blood vessel wall of the patient's CS). When expanded to the expanded state, the diameter of the anchor component 1332 may be substantially larger than the diameter of the puncture hole penetrated through the tissue wall such that the anchor component 1332 is configured to retract the tissue wall as the balloon element 1300 is retracted through the puncture hole. In some examples, the diameter of the anchor component 1332 is sufficient to retract the tissue wall when the anchor component 1332 is in the first expanded state. In some examples, the diameter of the anchor component 1332 is sufficient to retract the tissue wall when the anchor component 1332 is in the second expanded state. The position of the balloon element 1300 can be fixed relative to the tissue wall as the anchor component 1332 retracts the tissue wall.

[0125] In some embodiments, the proximal surface 1334 of the anchor component 1332 can be angled to secure the balloon element 1300 within the patient when the anchor component 1332 is expanded. The proximal surface 1334 can capture the tissue wall without enlarging the puncture hole in the tissue wall. In some examples, as shown in FIG. 13 , the proximal surface 1334 can define a plane perpendicular to the longitudinal axis of the balloon element 1300. In some examples, the proximal surface 1334 can be angled proximally (e.g., the angle between the longitudinal axis of the balloon element 1300 and the proximal surface 1334 can be less than 90 degrees). Further, in some examples, the proximal surface 1334 can be angled distally (e.g., the angle between the longitudinal axis of the balloon element 1300 and the proximal surface 1334 can be greater than 90 degrees). In some embodiments, the proximal surface 1334 of the anchor component 1332 may not form a uniform or constant angle with respect to the longitudinal axis of the balloon element 1330. In certain embodiments, the anchor component 1332 may have a "sloped" shape where 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.

[0126] In some embodiments, the shunt component 1330 and the anchor component 1332 may share an internal lumen such that both the shunt component 1330 and the anchor component 1332 expand simultaneously. In some examples, when the anchor component 1332 expands to a first expanded state, the shunt component 1330 may expand to a first expanded state. The diameter of the anchor component 1332 in the first expanded state may be larger than the diameter of the shunt component 1330 in the first expanded state. In some examples, when the anchor component 1332 expands to a second expanded state, the shunt component 1330 may expand to a second expanded state. The diameter of the anchor component 1332 in the second expanded state may be larger than the diameter of the shunt component 1330 in the second expanded state.

[0127] The diameter of the shunt component 1330 can be sized to shunt a tissue wall when the balloon element 1300 is in an expanded state (e.g., a first expanded state and / or a second expanded state). In some examples, after the balloon element 1300 is expanded, energy (e.g., ablation energy, radiofrequency (RF) energy, phased RF energy, thermal energy, cryogenic energy, pulsed ablation energy (e.g., pulsed field ablation (PFA)), microwave energy, laser energy, ultrasound 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, as shown in FIG.

[0128] 14 is a schematic diagram of an exemplary expandable element, such as a balloon element 1400, in accordance with an embodiment of the present disclosure. The balloon element 1400 includes an anchor component 1432 and a shunt component 1430.

[0129] In some embodiments, the balloon element 1400 can be expanded to a first expanded state, for example, where the anchor component 1432 is expanded and the shunt component 1430 is deflated (e.g., not expanded). In some embodiments, for example, as shown in FIG. 14 , the balloon element 1400 is expanded to a second expanded state (e.g., a fully expanded state), for example, where both the anchor component 1432 and the shunt component 1430 are expanded. In some embodiments, when the balloon element 1400 is fully expanded (e.g., in the second expanded state), the anchor component 1432 has a first diameter and the shunt component 1430 has a second diameter, the first diameter being larger than the second diameter. In some examples, the difference between the diameter of the anchor component 1432 (e.g., the first diameter) and the diameter of the shunt component 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.

[0130] In some embodiments, the anchor component 1432 is configured to facilitate placement of the balloon element 1400 within a patient (e.g., at a target location in a blood vessel or anatomical structure). In some embodiments, the balloon element 1400 is expanded from a compressed state to an expanded state (first expanded state and / or second expanded state) after the puncture element penetrates and punctures the tissue wall. The diameter of the anchor component 1432, when expanded to the expanded state, may be substantially larger than the diameter of the puncture hole through the tissue wall such that the anchor component 1432 is configured to retract the tissue wall as the balloon element 1400 is retracted through the puncture hole. In some examples, the diameter of the anchor component 1432 is large enough to retract the tissue wall when the anchor component 1432 is in the first expanded state. In some examples, the diameter of the anchor component 1432 is large enough to retract the tissue wall when the anchor component 1432 is in the second expanded state. The position of the balloon element 1400 may be fixed relative to the tissue wall as the anchor component retracts the tissue wall.

[0131] In some embodiments, the balloon element 1400 is a multi-balloon element, consisting of multiple separately inflatable balloons. In some examples, the balloon element 1400 can be a double balloon, with the anchor component 1432 being the first balloon and the shunt component 1430 being the second balloon. The first and second balloons may not share a lumen, so that the anchor component 1432 and the shunt component 1430 are inflatable independently of one another.

[0132] In some examples, the shunt component 1430 may be configured to remain contracted when the anchor component 1432 is expanded to a first expanded state. In some examples, the shunt component 1430 may expand to a first expanded state when the anchor component 1432 is expanded to a first expanded state. In some examples, the shunt component 1430 may expand to a second expanded state when the anchor component 1432 is expanded to a first expanded state. In some examples, the shunt component 1430 may be configured to remain contracted when the anchor component 1432 is expanded to a second expanded state. In some examples, the shunt component 1430 may expand to a first expanded state when the anchor component 1432 is expanded to a second expanded state. In some examples, the shunt component 1430 may expand to a second expanded state when the anchor component 1432 is expanded to a first expanded state. In some examples, the shunt component 1430 may expand to a second expanded state when the anchor component 1432 is expanded to a second expanded state. In some examples, the anchor component 1432 may remain contracted when the shunt component 1430 is expanded to a first expanded state. In some examples, when the shunt component 1430 is expanded to the second expanded state, the anchor component 1432 may remain contracted.

[0133] According to some embodiments, the diameter of the shunt component 1430 can be sized to shunt a tissue wall when the balloon element 1400 is in an expanded state (e.g., a first expanded state and / or a second expanded state). In some examples, after the balloon element 1400 is expanded, energy (e.g., ablation energy, radiofrequency (RF) energy, phased RF energy, thermal energy, cryogenic energy, pulsed ablation energy (e.g., pulsed field ablation (PFA)), microwave energy, laser energy, ultrasound energy, etc.) can be delivered to one or more electrodes disposed on the shunt component 1430 to ablate tissue surrounding the shunt component 1430, as shown in FIG.

[0134] FIG. 15 is a flow diagram illustrating a process 1500 for creating a shunt in a patient according to an embodiment of the present disclosure. Aspects of an embodiment of process 1500 may be performed, for example, by a shunt catheter system or controller (e.g., system 104 of FIG. 1 , controller 112 of FIG. 1 ). One or more steps of process 1500 are optional and / or may be modified by one or more steps of other embodiments described herein. Additionally, one or more steps of other embodiments described herein may be added to process 1500. In some embodiments, the shunt may be formed in the patient's coronary sinus. In certain embodiments, the shunt includes an opening between the patient's coronary sinus and the left atrium.

[0135] In step 1502, in some embodiments, process 1500 includes deploying a shunt catheter in a first state, the shunt catheter including a catheter shaft having distal and proximal ends and a shaft lumen, a shunt element having proximal and distal ends, and a puncture element disposed proximate the distal end of the shunt element. In some embodiments, the shunt element is disposed within the shaft lumen in the first state. In certain embodiments, the catheter shaft has a shaft opening, and the shunt element extends from the catheter shaft through the shaft opening. In certain embodiments, deploying the shunt catheter includes inserting the shunt catheter into the patient's coronary sinus through the patient's superior vena cava. In certain embodiments, deploying the shunt catheter includes inserting the shunt catheter into the patient's coronary sinus through the patient's inferior vena cava.

[0136] In step 1504, process 1500 includes positioning a shunt catheter near a target location in a patient. In step 1506, process 1500 includes manipulating the shunt catheter to a second state, e.g., wherein the shunt element extends from the catheter shaft at an angle greater than 0 degrees at a proximal end of the shunt element in the second state. In some embodiments, the shunt catheter includes an apposition element disposed proximate to the shunt element, the apposition element protruding from the catheter shaft in the second state. In certain embodiments, the catheter shaft has a shaft opening, and the shunt element extends from the catheter shaft through the shaft opening.

[0137] In step 1508, the process 1500 may include determining the location of the shunt element using an imaging device. In some embodiments, the imaging device includes one or more visualization elements positioned proximate to the shunt element.

[0138] In step 1510, process 1500 includes puncturing an opening at a target location using a puncture element. In some embodiments, the target location is in the patient's coronary sinus. In certain embodiments, the shunt catheter includes an expandable element including an anchor component (e.g., anchor component 1332) and a shunt component (e.g., shunt component 1330). In some embodiments, process 1500 includes positioning the anchor component at the target location distal to the opening. In step 1512, process 1500 includes expanding the anchor component of the expandable element to a first expanded state. In some embodiments, the shunt component remains contracted in the first expanded state. In certain embodiments, process 1500 includes moving the expandable element proximally to allow the anchor component to retract the tissue wall at the target location.

[0139] In step 1514, in certain examples, process 1500 includes expanding an expandable element of the shunt component to a second expanded state. In some examples, process 1500 includes expanding the opening using an expandable element (e.g., expandable element 312 of FIG. 3). In certain embodiments, process 1500 includes expanding the opening using a shunt component of the expandable element.

[0140] In step 1516, process 1500 includes treating tissue surrounding the opening (e.g., by ablating, displacing, cauterizing, or shrinking tissue) using the expandable element in the first or second expanded 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 includes an anchor component and a shunt component (e.g., anchor component 1332 and shunt component 1330). In certain embodiments, the anchor component and the shunt component each have multiple states including a compressed state, a first expanded state, and a second expanded state. In some examples, the shunt component is expanded in the second state and configured to deliver energy (e.g., ablation energy, radiofrequency (RF) energy, phased RF energy, thermal energy, cryogenic energy, pulsed ablation energy (e.g., pulsed field ablation (PFA)), microwave energy, laser energy, ultrasound energy, etc.) to the tissue surrounding the opening.

[0141] In some embodiments, the expandable element is expanded from a compressed state to an expanded state (first expanded state and / or second expanded state) after the puncturing element penetrates and punctures the tissue wall. The diameter of the anchor component when expanded to the expanded state may be substantially larger than the diameter of the puncture hole through the tissue wall such that the anchor component is configured to retract the tissue wall as the expandable element is retracted through the puncture hole. In some examples, the diameter of the anchor component is large enough to retract the tissue wall when the anchor component is in the first expanded state. In some examples, the diameter of the anchor component is large enough to retract the tissue wall when the anchor component is in the second expanded state. The position of the expandable element may be fixed relative to the tissue wall as the anchor component retracts the tissue wall.

[0142] In some embodiments, the shunt and anchor components may share an internal lumen such that both the shunt and anchor components are inflated simultaneously. In some embodiments, the shunt and anchor components may be separately inflatable balloons. In some instances, the shunt and anchor components may not share a lumen, and thus the anchor and shunt components are inflatable independently of one another.

[0143] In certain embodiments, process 1500 includes placing an anchor component at a target location distal to the opening, expanding the anchor component to one of a first expanded state or a second expanded state while the shunt component remains in a compressed state, and moving the expandable element proximally to allow the anchor component to retract the tissue wall at the target location. In certain embodiments, process 1500 then includes expanding the shunt component of the expandable element to one of the first expanded state or the second expanded state to expand the opening. In some embodiments, process 1500 then includes treating tissue surrounding the opening (e.g., by ablating, displacing, cauterizing, or shrinking tissue) using the shunt component.

[0144] In 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 may include removing the catheter shaft, the puncture element, and the shunt element. In certain embodiments, process 1500 does not leave any implant device at the target location. In some embodiments, the shunt is created by creating an opening between the patient's coronary sinus and the left atrium. In certain embodiments, the shunt catheter is removed from the patient's coronary sinus. In certain embodiments, the created shunt is an opening that does not include an implant (e.g., a frame or structure to support the opening). In some embodiments, the shunt consists of an opening between the patient's coronary sinus and the left atrium, and the shunt does not include an implant.

[0145] According to some embodiments, process 1500 includes creating a shunt using a shunt element of a shunt catheter. In certain embodiments, the shunt includes an enlarged opening between the patient's coronary sinus and left atrium. In some embodiments, the shunt does not include any implants.

[0146] According to one aspect, 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 within 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 expandable in the second state; and at least one electrode of one or more electrodes disposed on the balloon element.

[0147] According to another aspect, the catheter shaft defines a first axis and the balloon shaft defines a second axis in the second state, the second axis and the first axis forming an angle greater than 0 degrees.

[0148] According to another embodiment, the angle is greater than 10 degrees.

[0149] According to another embodiment, the angle is 30 degrees.

[0150] According to another aspect, the balloon element has a balloon length along the second axis and a balloon width perpendicular to the second axis, and when the balloon element is inflated, the balloon length is greater than the balloon width.

[0151] According to another aspect, the balloon element has a balloon length along the second axis and a balloon width perpendicular to the second axis, and when the balloon element is inflated, the balloon length is less than the balloon width.

[0152] According to another embodiment, the balloon element has a diameter in the range of 3 millimeters to 15 millimeters when the balloon element is inflated.

[0153] According to another embodiment, the balloon element has a diameter in the range of 5 millimeters to 10 millimeters when the balloon element is inflated.

[0154] According to another aspect, the balloon element has a first expanded state and a second expanded state, the balloon element having a first balloon diameter in the first expanded state and the balloon element having a second balloon diameter in the second expanded state, the first balloon diameter being different from the second balloon diameter.

[0155] According to another aspect, the balloon element includes a first inflatable portion having a first balloon diameter when the balloon element is inflated and a second inflatable portion having a second balloon diameter, the first balloon diameter being different from the second balloon diameter.

[0156] According to another aspect, the balloon element includes a narrow section in the center of the balloon element, 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, the narrow section being between the first and second sections, the narrow section having a diameter smaller than the diameter of the first section or the diameter of the second section.

[0157] According to another aspect, the balloon element has a cross-sectional shape perpendicular to the second axis, the cross-sectional shape being circular, elliptical, or rectangular.

[0158] According to one aspect, a shunt catheter system includes a shunt catheter, an energy source connected to the shunt catheter, and a controller connected to the energy source including one or more processors, wherein the shunt catheter includes a catheter shaft having a distal end and a proximal end, the catheter shaft including a shaft lumen, a shunt element disposed within the shaft lumen in a first state and extending from the catheter shaft in a second state, and an apposition element disposed adjacent to the shunt element and protruding from the catheter shaft in the second state, wherein the one or more processors are configured to control the energy source to deliver energy to the shunt catheter.

[0159] According to another aspect, the shunt catheter system further includes an imaging device including one or more visualization elements positioned in proximity to the shunt element to determine the location of the shunt element within the patient's heart, and a display for visualizing the location.

[0160] According to another aspect, a method for creating a shunt includes deploying a shunt catheter in a first state, the shunt catheter including: a catheter shaft having a distal end and a proximal end, the catheter shaft including a shaft lumen; a shunt element having a proximal end and a distal end, the shunt element being disposed within the shaft lumen in the first state; and a puncture element disposed adjacent to the distal end of the shunt element; positioning the shunt catheter near a target location in a patient; manipulating the shunt catheter to a second state, the shunt element extending from the catheter shaft at an angle greater than 0 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 dilating the opening using the shunt element.

[0161] According to another aspect, the shunt element includes an expandable element disposed at a distal end of the shunt element, the expandable element having a plurality of states.

[0162] According to another aspect, the multiple states of the expandable element include a compressed state, a first expanded state, and a second expanded state.

[0163] According to another aspect, the method further includes treating tissue surrounding the opening using the expandable element in the first expanded state.

[0164] According to another aspect, the method further includes treating tissue surrounding the opening using the expandable element in the second expanded state.

[0165] According to another aspect, the catheter shaft has a shaft opening and the shunt element extends from the catheter shaft through the shaft opening.

[0166] According to another aspect, the method further includes determining the location of the shunt element using an imaging device, the imaging device including one or more visualization elements positioned proximate to the shunt element.

[0167] According to another aspect, the target location is in the patient's coronary sinus.

[0168] According to another aspect, the method further includes deploying a shunt catheter in a first condition, the shunt catheter including inserting the shunt catheter through the patient's superior vena cava or inferior vena cava and into the patient's coronary sinus.

[0169] According to another aspect, the method further includes removing the shunt catheter from the patient.

[0170] According to another aspect, the method further includes creating a shunt using a shunt element, the shunt including an enlarged opening between the patient's coronary sinus and left atrium.

[0171] According to another embodiment, the shunt does not include any implants.

[0172] According to one aspect, 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 within the shaft lumen in a first state and extending from the catheter shaft in a second state; and a balloon element disposed on the balloon shaft and expandable in the second state, wherein the balloon is configured to expand in the second state and 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, ultrasound energy, etc.) to a target location in a patient.

[0173] According to another aspect, the target location is in the patient's coronary sinus.

[0174] According to another aspect, the balloon is configured to dilate an opening at the target location.

[0175] According to another aspect, the energy source is configured to deliver 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 energy, or ultrasound energy.

[0176] According to another aspect, treating the tissue surrounding the opening includes ablating, displacing, cauterizing, or shrinking the tissue surrounding the opening.

[0177] According to another aspect, the balloon element includes an anchor component configured to facilitate placement of the balloon element within the patient's body and a shunt component mechanically coupled to the anchor component.

[0178] According to another aspect, the anchor component has a first diameter and the shunt component has a second diameter, the first diameter being larger than the second diameter.

[0179] According to another aspect, at least one electrode of the one or more electrodes is disposed on the shunt component of the balloon element.

[0180] According to another aspect, the anchor component and the shunt component share an internal lumen.

[0181] According to another embodiment, 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.

[0182] According to another aspect, the anchor component is configured to expand to a first expanded state and the shunt component is configured to remain contracted in the first expanded state, and the anchor component is configured to expand to a second expanded state and the shunt component is configured to remain contracted in the second expanded state.

[0183] According to another aspect, the anchor component is configured to retract the tissue wall in the first expanded state.

[0184] According to another embodiment, the shunt component has a diameter in the second expanded state within the range of 2 millimeters to 12 millimeters.

[0185] According to another aspect, the anchoring portion has a diameter in the second expanded state within the range of 4 millimeters to 16 millimeters.

[0186] According to another aspect, the balloon element is folded into a plurality of pleats in the first state, and a first electrode of the one or more electrodes is disposed entirely on the pleat surface on one side of one of the plurality of pleats.

[0187] According to another aspect, at least one electrode of the one or more electrodes has a central longitudinal portion and a plurality of protrusions extending from the central portion, at least some of the plurality of protrusions being parallel.

[0188] According to another aspect, the anchor component has a proximal face that defines a plane perpendicular to the longitudinal axis of the balloon element.

[0189] According to another aspect, the anchor component has a proximal face that forms an angle of less than 90 degrees with respect to the longitudinal axis of the balloon element.

[0190] According to another aspect, the anchor component has a proximal face that forms an angle greater than 90 degrees with respect to the longitudinal axis of the balloon element.

[0191] According to another aspect, the anchor component has an angled shape such that a first portion of the proximal surface of the anchor 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 anchor component forms an obtuse angle with respect to the longitudinal axis of the balloon element.

[0192] According to another aspect, the target location is in the patient's interatrial septum.

[0193] According to another aspect, the shunt element includes an expandable element disposed at a distal end of the shunt element, the expandable element including an anchor component, the anchor component having a plurality of states including a compressed state, a first expanded state, and a second expanded state, and the method includes expanding the anchor component to one of the first expanded state or the second expanded state when the anchor component is disposed distal to the target location, and moving the shunt element proximally to enable the anchor component to retract the tissue wall at the target location.

[0194] Various changes and modifications can be made without departing from the scope and spirit of the present disclosure. For example, while the above embodiments refer to particular features, the scope of the present invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations that fall within the scope of the claims, together with all equivalents thereof.

Claims

1. A shunt catheter, a catheter shaft having a distal end and a proximal end, the catheter shaft including a shaft lumen; a balloon shaft disposed within 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 expandable in the second state; at least one electrode of one or more electrodes disposed on the balloon element; Includes shunt catheter.

2. 2. The shunt catheter of claim 1, wherein the catheter shaft defines a first axis, the balloon shaft defines a second axis in the second state, and the second axis and the first axis form an angle greater than 0 degrees.

3. 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, and when the balloon element is inflated, the balloon length is greater than the balloon width.

4. 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, and when the balloon element is inflated, the balloon length is less than the balloon width.

5. The shunt catheter of claim 1 , wherein the balloon element has a diameter within the range of 3 millimeters to 15 millimeters when the balloon element is inflated.

6. 2. The shunt catheter of claim 1, wherein the balloon element has a first expanded state and a second expanded state, the balloon element having a first balloon diameter in the first expanded state and the balloon element having a second balloon diameter in the second expanded state, the first balloon diameter being different from the second balloon diameter.

7. 2. The shunt catheter of claim 1, wherein the balloon element includes a first expandable portion having a first balloon diameter when the balloon element is inflated, and a second expandable portion having a second balloon diameter, the first balloon diameter being different from the second balloon diameter.

8. 2. The shunt catheter of claim 1, wherein the balloon element includes a narrow section in the center of the balloon element, 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, the narrow section being between the first section and the second section, and the narrow section having a diameter smaller than the diameter of the first section or the diameter of the second section.

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

10. 2. The shunt catheter of claim 1, wherein the balloon element comprises: an anchor component configured to facilitate placement of the balloon element within a patient; a shunt component mechanically coupled to the anchor component; A shunt catheter comprising:

11. The shunt catheter of claim 10, wherein the anchor component has a first diameter and the shunt component has a second diameter, the first diameter being larger than the second diameter.

12. The shunt catheter of claim 10 , wherein the at least one electrode 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 internal 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. 11. The shunt catheter of claim 10, wherein the anchor component is configured to expand to a first expanded state and the shunt component is configured to remain contracted in the first expanded state, and the anchor component is configured to expand to a second expanded state and the shunt component is configured to remain contracted in the second expanded state.

Images