Patent ID: 12201354

While the present disclosure is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The present disclosure, however, is not to limit the present disclosure to the particular embodiments described. On the contrary, the present disclosure is intended to cover all modifications, equivalents, and alternatives falling within the scope of the present disclosure as defined by the appended claims.

DETAILED DESCRIPTION

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

Unless otherwise indicated, all numbers expressing feature sizes, amounts, and physical properties used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by those skilled in the art utilizing the teachings disclosed herein. The use of numerical ranges by endpoints includes all numbers within that range (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5) and any number within that range.

Although illustrative methods may be represented by one or more drawings (for example, flow diagrams, communication flows, etc.), the drawings should not be interpreted as implying any requirement of, or particular order among or between, various steps disclosed herein. However, some embodiments may require certain steps and/or certain orders between certain steps, as may be explicitly described herein and/or as may be understood from the nature of the steps themselves (for example, the performance of some steps may depend on the outcome of a previous step). Additionally, a “set,” “subset,” or “group” of items (for example, 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. A “plurality” means more than one.

As used herein, the term “based on” is not meant to be restrictive, but rather indicates that a determination, identification, prediction, calculation, and/or the like, is performed by using, at least, the term following “based on” as an input. For example, predicting an outcome based on a particular piece of information may additionally, or alternatively, base the same determination on another piece of information. In some embodiments, the term “receive” or “receiving” means obtaining from a data repository (for example, database), from another system or service, from another software, or from another software component in a same software. In certain embodiments, the term “access” or “accessing” means retrieving data or information, and/or generating data or information.

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 to flow through. In some embodiments, examples of interatrial shunt devices (IASDs) include implants or shunting catheters. For example, devices reside in the interatrial septum, with risk for right-to-left shunting and systemic embolization. In some examples, preservation of the interatrial septum is important with an increasing number of left-sided transseptal transcatheter interventions. Improved IASDs for safer and better procedures are needed. At least some embodiments of the present disclosure are directed to a shunting catheter for deployment through a patient's coronary sinus (CS) for creating a shunt between the CS and the patient's left atrium (LA). At least some embodiments of the present disclosure are directed to a shunting catheter for deployment through a patient's atrial septum (AS) for creating a shunt between the patient's right atrium (RA) and LA.

A patient's CS ostium may have a diameter of from about 10 mm to about 20 mm. As the CS is a relatively small vessel, at least some embodiments of the present disclosure include features of a shunting catheter that helps protect a patient's vessels during deployment and/or elements for stabilizing the catheter during the procedure. In embodiments, the shunting catheter includes a catheter shaft and an ablation assembly, the ablation assembly including an ablation shaft and an ablation mechanism. The shunting catheter further includes a puncture mechanism disposed proximate to a distal end of the ablation mechanism. In some embodiments, the catheter shaft is made of flexible materials that bends according to the anatomy of the CS to conform to the shape of the patient's CS. In some embodiments, the catheter shaft includes a stabilizing element such as distal tip that has a curve (for example, a pre-existing curve) conforming to the shape of a patient's CS to help stabilize the catheter and minimize potential damage to the vessel wall of a patient's CS.

In certain embodiments, the ablation assembly is disposed in a shaft lumen of the catheter shaft at a first state, and is extended from the catheter shaft at a second state. In some embodiments, a shunt is formed by creating an opening between the patient's CS and LA. In some embodiments, a shunt is formed by creating an opening between the patient's RA and LA. In certain embodiments, the shunting catheter is inserted through the patient's superior vena cava (SVC) via a transjugular approach. In certain embodiments, the shunting catheter is inserted through the patient's inferior vena cava (IVC) via a transfemoral approach.

FIG.1is a diagram illustrating an exemplary clinical setting100for treating a heart101of a patient102using a shunting catheter system104, in accordance with embodiments of the present disclosure. In certain embodiments, the shunting catheter system104includes a shunting device106. As will be appreciated by the skilled artisan, the clinical setting100may have other components and arrangements of components that are not shown inFIG.1. In some embodiments, the shunting catheter system104includes or is coupled to an imaging system (for example, an X-ray system), which may include one or more visualization elements and a display108. In some embodiments, one or more visualization elements may be disposed on the shunting device106. In certain embodiments, the imaging system can help guide a physician's operation of the shunting device106during a procedure.

According to certain embodiments, the shunting device106includes a shunting catheter110, a controller112, and an energy source114(for example, a generator). In some embodiments, the controller112is configured to control functional aspects of the shunting device106. In some embodiments, the controller112is configured to control the energy source114to deliver energy to the shunting catheter110. In certain embodiments, the controller112may be connected to the one or more visualization elements to facilitate positioning of the shunting catheter110in a patient's heart during procedure. In some embodiments, the energy source114is connected to the controller112. In some embodiments, the energy source114may be integrated with the controller112.

According to some embodiments, the shunting device106includes a handle116, a catheter shaft118, and an ablation assembly120. In certain embodiments, the handle116is configured to be operated by a user to position the ablation assembly120at a target shunting location. In certain embodiments, the ablation assembly120includes a puncture element (for example, a puncture needle) configured to puncture through a vessel wall. In certain embodiments, the ablation assembly120is connected to the energy source114to provide shunting. For example, the ablation assembly120receives energy from the energy source114to deliver energy (for example, ablation energy, such as radiofrequency (RF) energy, phased RF energy, cryogenic energy, thermal energy, pulse energy, laser energy, microwave energy, ultrasound energy, and/or the like) to the target location (for example, a target tissue) at a cardiovascular system (for example, a circulatory system) wall. In certain embodiments, the energy source114provides energy in a first form (for example, electrical energy) to the ablation assembly120, and the ablation assembly120delivers the ablation energy to the target location in a second form (for example, radiofrequency (RF) energy, phased RF energy, cryogenic energy, thermal energy, pulse energy, laser energy, microwave energy, ultrasound energy, and/or the like).

According to certain embodiments, during deployment, the shunting device106including a portion of the catheter shaft118enters through a patient's CS ostium. The shunting device106may then be oriented through one or more mechanisms in the patient's CS, as will be discussed in more detail below. In some embodiments, in order to conform to the shape of the patient's CS, the catheter shaft118is made of flexible materials and/or has a structure that may bend according to the anatomy of the CS. In certain embodiments, during deployment, the puncture element creates an opening at a target tissue (for example, a vessel wall), and then the ablation assembly120enlarges the opening at the target tissue.

In certain embodiments, the controller112controls the delivery of ablation energy (for example, radiofrequency (RF) energy, phased RF energy, cryogenic energy, thermal energy, pulse energy, laser energy, microwave energy, ultrasound energy, and/or the like) via the ablation assembly120after and/or when the opening is generated by the puncture element and/or the ablation assembly120.

In certain embodiments, the shunting catheter110includes a cage having a plurality of expandable struts. In certain embodiments, the struts are configured to receive energy from the energy source and deliver ablation energy to a target location of a patient. In certain embodiments, one or more of the struts carry an electrode, and the electrode is configured to receive energy from the energy source and deliver ablation energy to a target location of a patient. In some embodiments, the struts are self-expandable. In certain embodiments, the struts are expandable via an actuator (for example, an inflatable balloon) carried within the cage. In certain embodiments, the shunting catheter110further includes a plurality of positioning elements coupled to the plurality of expandable struts. In some embodiments, the plurality of positioning elements are configured to contact tissue at the target location of the patient and thereby properly position the plurality of expandable struts at the target location of the patient. In certain embodiments, the positioning elements are self-expandable.

In certain embodiments, the shunting catheter110includes an apposition element122disposed proximate to the ablation assembly120. In some embodiments, the apposition element122is disposed within a shaft (for example, an outer shaft) at the first state. In some embodiments, the apposition element122is protruded from the catheter shaft118at the first state and/or at the second state. In certain embodiments, the apposition element122can appose to a cardiovascular system wall (for example, the front wall or back wall of the CS, a left atrium wall, a right atrium wall, etc.) at the second state, for example, to help position and/or stabilize the ablation assembly120. In certain embodiments, the apposition element122includes a braid structure. In some embodiments, the apposition element122may include a nitinol braid that can be held within the catheter shaft118. In certain embodiments, after deployment and stabilization of the catheter shaft118, the ablation assembly120and the puncture element may then be deployed. In some embodiments, the ablation assembly120is configured to deliver ablation energy to target tissues for creating a shunt in the patient's CS or AS.

According to some embodiments, various components (for example, the controller112) of the shunting catheter system104may be implemented on one or more computing devices. In certain embodiments, a computing device may include any type of computing device suitable for implementing embodiments of the disclosure. Examples of computing devices include specialized computing devices or general-purpose computing devices such as workstations, servers, laptops, portable devices, desktop, tablet computers, hand-held devices, general-purpose graphics processing units (GPGPUs), and the like, all of which are contemplated within the scope ofFIG.1with reference to various components of the shunting catheter system104.

In some embodiments, a computing device (for example, the controller112) includes a bus that, directly and/or indirectly, couples the following devices: a processor, a memory, an input/output (I/O) port, an I/O component, and a power supply. Any number of additional components, different components, and/or combinations of components may also be included in the computing device. The bus represents what may be one or more busses (such as, for example, an address bus, data bus, or combination thereof). Similarly, in some embodiments, the computing device may include a number of processors, a number of memory components, a number of I/O ports, a number of I/O components, and/or a number of power supplies. Additionally, any number of these components, or combinations thereof, may be distributed and/or duplicated across a number of computing devices. In some embodiments, various components or parts of components (for example, controller112, shunting catheter110, etc.) can be integrated into a physical device.

In some embodiments, the shunting catheter system104includes one or more memories (not illustrated). The one or more memories includes computer-readable media in the form of volatile and/or nonvolatile memory, transitory and/or non-transitory storage media and may be removable, nonremovable, or a combination thereof. Media examples 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 or other magnetic storage devices; data transmissions; and/or any other medium that can be used to store information and can be accessed by a computing device such as, for example, quantum state memory, and/or the like. In some embodiments, the one or more memories store computer-executable instructions for causing a processor (for example, the controller112) to implement aspects of embodiments of system components discussed herein and/or to perform aspects of embodiments of methods and procedures discussed herein.

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

In some embodiments, the memory may include a data repository that may be implemented using any one of the configurations described below. A data repository may include random access memories, flat files, XML files, and/or one or more database management systems (DBMS) executing on one or more database servers or a data center. A database management system may be a relational DBMS (RDBMS), hierarchical DBMS (HDBMS), multidimensional DBMS (MDBMS), object oriented DBMS (ODBMS or OODBMS) or object relational DBMS (ORDBMS), and/or the like. The data repository may be, for example, a single relational database. In some cases, the data repository may include a plurality of databases that can exchange and aggregate data by a data integration process or software application. In an exemplary embodiment, at least part of the data repository may be hosted in a cloud data center. In some cases, a data repository may be hosted on a single computer, a server, a storage device, a cloud server, or the like. In some other cases, a data repository may be hosted on a series of networked computers, servers, or devices. In some cases, a data repository may be hosted on tiers of data storage devices including local, regional, and central.

Various components of the shunting catheter system104can communicate via or be coupled to via a communication interface, for example, a wired or wireless interface. The communication interface includes, but is not limited to, any wired or wireless short-range and long-range communication interfaces. The wired interface can use cables, umbilicals, and the like. The short-range communication interfaces may be, for example, local area network (LAN), interfaces conforming to known communications standards, such as Bluetooth™ standard, IEEE 802 standards (for example, IEEE 802.11), a ZigBee™ or similar specification, such as those based on the IEEE 802.15.4 standard, or other public or proprietary wireless protocol. The long-range communication interfaces may be, for example, wide area network (WAN), cellular network interfaces, satellite communication interfaces, etc. The communication interface may be either within a private computer network, such as intranet, or on a public computer network, such as the internet. Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the embodiments described above refer to particular features, the scope of this 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 as fall within the scope of the claims, together with all equivalents thereof.

FIG.2is a schematic diagram illustrating an example of a shunting device200to be deployed in a heart of a patient, in accordance with embodiments of the present disclosure.FIG.2is merely an example. One of the ordinary skilled in the art would recognize many variations, alternatives, and modifications. As shown, the shunting device200includes a shunting catheter202to be deployed to a patient's coronary sinus (CS)210via the CS ostium211. In certain embodiments, the shunting catheter202is deployed to a patients right atrium (RA) via the inferior vena cava (IVC). In some embodiments, the shunting catheter202includes a catheter shaft204, an ablation assembly206, and an apposition element208. In certain embodiments, the catheter shaft204has a curve at its distal end205. In some embodiments, as illustrated, the ablation assembly206is extended from the catheter shaft204at a state to provide shunting (for example, a second state different from a first state to deploy the catheter202). In certain examples, the ablation assembly206forms an angle greater than 10 degrees from the distal end205of the catheter shaft204. In some examples, the ablation assembly206forms an angle greater than 30 degrees from the distal end205of the catheter shaft204. In some embodiments, the ablation assembly206forms an angle proximate to 90 degrees from the catheter shaft204. In some embodiments, the ablation assembly206forms an angle in the range of 10 degrees to 120 degrees from the catheter shaft204.

In some embodiments, the ablation assembly206includes a cage having a plurality of expandable struts. In certain embodiments, the struts are configured to receive energy from the energy source and deliver ablation energy to a target location of a patient. In certain embodiments, one or more of the struts carry an electrode, and the electrode is configured to receive energy from the energy source and deliver ablation energy to a target location of a patient. In some embodiments, the struts are self-expandable. In certain embodiments, the struts are expandable via an actuator (for example, an inflatable balloon) carried within the cage. In certain embodiments, the ablation assembly206further includes a plurality of positioning elements coupled to the plurality of expandable struts. In some embodiments, the plurality of positioning elements are configured to contact tissue at the target location of the patient and thereby properly position the plurality of expandable struts at the target location of the patient. In certain embodiments, the positioning elements are self-expandable.

In some embodiments, the catheter shaft204is made of flexible material that may curve with the anatomy of the patient's CS210. In certain embodiments, for example, the catheter shaft204may include polyether block amide, nylon, silicone, or a combination thereof. In some embodiments, the catheter shaft204may be a multi-layered and multi-material component. In some examples, the catheter shaft204is reinforced with a braid and/or can have an etched or casted liner. In certain embodiments, the braid for reinforcing the catheter shaft204may be made of nitinol. In some embodiments, the liner may be made from polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE), copolymers of polyamide and polyether, or a combination thereof. In some embodiments, the catheter shaft204is coated for lubricity with a hydrophilic coating, or other types of coating suitable for coating a catheter shaft as known by a skilled person in the art.

In some embodiments, the shunting catheter202has a diameter of from about 2 mm to about 5 mm. In certain embodiments, the shunting catheter202has a diameter from about 2.5 mm to about 4.5 mm. In some embodiments, the shunting catheter202has a diameter from about 3 mm to about 4 mm. In certain embodiments, the shunting catheter202may have a diameter allowing it to pass through vessels and parts of the cardiovascular system to reach a target location.

FIG.3is a schematic diagram of a side view of an example of a shunting device300, in accordance with embodiments of the present disclosure.FIG.3is merely an example. One of the ordinary skilled in the art would recognize many variations, alternatives, and modifications. As shown, the shunting device300includes a shunting catheter302. In some embodiments, the shunting catheter302is configured to be delivered through a patient's coronary sinus (CS). In some embodiments, the shunting catheter302includes a catheter shaft304, an ablation assembly306, and an apposition element308.

According to some embodiments, the shunting catheter302may be inserted through a small vein in the patient's body, and then tracked to the patient's right atrium (RA). In certain embodiments, once the shunting catheter302is in the patient's RA, the shunting catheter302may be maneuvered into the CS ostium to gain alignment in the CS at a target location of on a wall between the patient's CS and LA. In other embodiments, once the shunting catheter302is in the patient's RA, the shunting catheter302may be aligned at a target location of the patient's atrial septum (AS).

According to certain embodiments, the catheter shaft304is made of flexible material that may curve with the anatomy of the patient's CS. In certain embodiments, the catheter shaft304may include polyether block amide, nylon, silicone, and/or a combination thereof. In some instances, the catheter shaft304may be a multi-layered and multi-material component. In some instances, the shunting catheter302may be made from multiple materials that are reflow soldered together. In certain instances, the shunting catheter302may be made from multiple materials that are bonded together with an over mold. In certain embodiments, a portion of the shunting catheter302houses other components of the shunting device300that are configured to interact with the patient's anatomy.

In some embodiments, the catheter shaft304is reinforced with a braid and can have an etched or casted liner. In certain embodiments, the braid for reinforcing the catheter shaft304may be made of nitinol. In some embodiments, the liner may be made from polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE), copolymers of polyamide and polyether, or a combination thereof. In certain embodiments, the catheter shaft304may be injection molded or extruded. In some embodiments, the catheter shaft304is coated for lubricity with a hydrophilic coating, or other types of coating suitable for coating a catheter shaft as known by a skilled person in the art.

In certain embodiments, the catheter shaft304may have multiple lumens. In embodiments, the multiple lumens may allow for the exchange and movement of various parts (for example, the ablation assembly306, the apposition element308) during deployment and/or shunting. In certain embodiments, the shunting catheter302is used to gain access into a patient's CS, the ablation assembly306including multiple lumens to gain access into the patient's LA.

According to some embodiments, the catheter shaft304has a distal end304aand a proximal end (not shown). In some embodiments, the catheter shaft304may include a stabilizing element such as distal tip305at the distal end304athat has a curve (for example, a pre-existing curve), for example, a curve conforming to the anatomy of a patient's CS. In some embodiments, the distal tip305may help with navigation when inserting the shunting catheter302into the patient's CS. In certain embodiments, the distal tip305may allow for proper positioning of the shunting catheter302during shunting. In some instances, the distal tip305may be made of a different material than other parts of the catheter shaft304. In some instances, for example, the distal tip305may be made of a material more flexible than the material of other parts of the catheter shaft304. In some embodiments, the distal tip305may be injection molded or machined to have a unique geometry (for example, a curve) for better stabilizing the catheter shaft304during deployment.

According to some embodiments, the distal tip305may have a length of from about 5 mm to about 85 mm. In certain embodiments, the catheter shaft304includes a shaft opening303. In some embodiments, a portion of the catheter shaft304between the shaft opening303and the distal end304ahas a curve. In some embodiments, the catheter shaft304defines a first axis307, and the ablation assembly306defines a second axis309at the second state after deployment. In certain embodiments, the second axis309and the first axis307form an angle greater than zero degrees. In certain embodiments, the second axis309and the first axis307form an angle greater than 10 degrees.

According to certain embodiments, the catheter shaft304includes a shaft lumen301, and the ablation assembly306is disposed in the shaft lumen301at a first state (for example, during deployment to position of the ablation assembly306). In certain embodiments, the ablation assembly306includes a proximal end306aand a distal end306b. In some embodiments, the ablation assembly306includes an ablation shaft312, an ablation mechanism313, and a puncture element314. In certain embodiments, the ablation shaft312has a pre-determined curve. In certain embodiments, the ablation mechanism313is extended from the catheter shaft304at the proximal end306aof the ablation assembly306at a second state (for example, a shunting state). In some embodiments, the ablation assembly306extends from the catheter shaft304through the shaft opening303. In certain instances, the puncture element314has a diameter (D1) in the range of about 2 millimeters to about 5 millimeters. In some embodiments, once the shunting catheter302is in position after deployment, the puncture element314may be used to puncture through the wall between a patient's CS and LA.

According to certain embodiments, an energy source coupled to the shunting catheter302may provide energy (for example, electrical energy) to the shunting catheter302, and the shunting catheter302may generate and deliver ablation energy (for example, radiofrequency (RF) energy, phased RF energy, cryogenic energy, thermal energy, pulse energy, laser energy, microwave energy, ultrasound energy, and/or the like) to a target location of the patient.

According to some embodiments, the puncture element314is disposed at the distal end306bof the ablation assembly306. In embodiments, the shaft opening303is not at the distal end304aof the catheter shaft304. In certain embodiments, the puncture element314has a configuration of regular trocar point, regular taper point, regular taper cutting, regular reverse cutting edge, regular diamond point, regular conventual cutting edge, regular blunt taper point, premium lancet point, premium diamond point, or premium cutting edge. In certain embodiments, the puncture element314is made of materials including nitinol, stainless steel, cobalt chromium, aluminum, and/or a combination thereof.

In embodiments, the ablation assembly306is configured to deliver ablation energy to a target tissue during shunting. In certain embodiments, the ablation energy delivered by the ablation assembly306may include radiofrequency (RF) energy, phased RF energy, cryogenic energy, thermal energy, pulse energy, laser energy, microwave energy, ultrasound energy, and/or the like. In certain embodiments, the energy delivered by the ablation assembly306punctures through tissue surrounding the target location to create an opening at the target location. In some embodiments, the energy delivered by the ablation assembly306ablates tissue surrounding the target location to solidify an opening at the target location. In certain embodiments, delivering energy via the ablation assembly306helps prevent tissue regrowth around the created shunt after the procedure.

According to some embodiments, the shunting catheter302further includes an outer shaft318disposed outside of at least a part of the catheter shaft304during deployment. In some embodiments, the outer shaft318is made of flexible material that may curve with the anatomy of the patient's CS. In certain embodiments, for example, the outer shaft318may include polyether block amide, nylon, silicone, or a combination thereof. In some instances, the outer shaft318may be a multi-layered and multi-material component.

In some examples, the outer shaft318is reinforced with a braid and can have an etched or casted liner. In some embodiments, the braid for reinforcing the catheter shaft304may be made of nitinol. In certain embodiments, the liner may be made from polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE), copolymers of polyamide and polyether, or a combination thereof. In some instances, the outer shaft318may include a reinforcing element (for example, a laser-cut tube). In certain embodiments, the outer shaft318may be injection molded or extruded. In some embodiments, the catheter shaft304is coated for lubricity with a hydrophilic coating, or other types of coating suitable for coating a catheter shaft as known by a skilled person in the art.

In certain examples, the outer shaft318and/or the catheter shaft304may house all of the catheter components until the desired target location is reached. In some embodiments, once the shunting catheter302has reached the target location, the outer shaft318may translate towards the proximal end of the catheter shaft304to expose the ablation assembly306and other components.

According to certain embodiments, the apposition element308is disposed within the outer shaft318at a first state (for example, during deployment). In embodiments, the apposition element308protrudes from the catheter shaft304during deployment. In certain embodiments, the apposition element308is flexible and compressed to fit within the outer shaft318, and configured to decompress and protrude from the catheter shaft304during deployment. In some embodiments, the apposition element308is disposed proximate to the ablation assembly306and/or the one or more shaft openings303. In some instances, the apposition element308is a braided structure including one or more nickel titanium wires. In some instances, the apposition element308is made of a flexible material having a portion protruding from the catheter shaft304. In some examples, the flexible material may be a foam. In some instances, the flexible material may be a balloon filled with a contrast solution that is visible under fluoroscopy. In some instances, the flexible material may be a polymer with a radiopaque marker added for visualization. In some embodiments, the radiopaque marker may include tantalum, platinum, gold, palladium, platinum-iridium or any radiopaque marker known by a skilled person in the art.

In certain embodiments, the apposition element308is configured to appose at least one wall in a patient's cardiovascular system (for example, CS, LA, etc.) such that the shunting catheter302is stabilized in one position once deployed. In some embodiments, the apposition element308is configured to appose two or more walls in a patient's cardiovascular system. According to some embodiments, the apposition element308has several benefits, one of which is the stabilization of catheter302after deployment. In some embodiments, any movement or lack thereof the protruding element (for example, a braided element) provides an estimated distance of how far the catheter302is away from the vessel wall of patient's CS. In addition, in instances where the apposition element308includes a braided element, such that when the braided element is apposing the vessel wall of a patient's CS, the openings between the braids still allow blood flow through the apposition element308, thus reducing the risk of thrombus formation caused by any occlusion in the vessel.

The apposition element308may be made of nitinol, and is reflow soldered or bonded to the catheter shaft304. In some embodiments, the apposition element308serves the purpose of pushing against the back wall of a patient's CS, to allow for the shunting catheter302to translate forward and against target location on a wall between patient's CS and LA. In certain embodiments, the apposition element308may include an elastic braided structure, and may thus expand and compress with force applied by the outer shaft318, or through other mechanical means.

In some embodiments, for example as shown, the apposition element308is disposed on the same side of the catheter shaft304as the ablation assembly306. In some embodiments, the apposition element308may be on an opposite side of the catheter shaft304from the ablation assembly306. In certain embodiments, the apposition element308may be configured to appose the wall between patient's CS and LA, instead of the back of patient's CS wall. In certain embodiments, this may allow the shunting device300to then penetrate through the patient's CS wall to gain access into the patient's LA. In embodiments, the apposition element308helps stabilize and position the shunting catheter302in the patient's CS at a target location.

FIGS.4A-4Care schematic diagrams of side views of an example of a shunting catheter400, in accordance with embodiments of the present disclosure. In some embodiments and as shown inFIGS.4A-4C, the shunting catheter400includes a catheter shaft402having a shaft lumen401, a shaft opening403, and an ablation assembly406disposed within the shaft lumen401at a first state (for example, during deployment to position the ablation assembly406) and extended from the shaft lumen401at a second state (for example, as shown inFIGS.4A-4C). In some embodiments, the shunting catheter400includes a crimping shaft412having a predetermined curve for an ablation mechanism413to deploy, and a puncture element414.

According to some embodiments, the ablation assembly406may have a telescoping feature (for example, the ablation mechanism413and the puncture element414being retractable into the crimping shaft412, as shown inFIG.4A) to allow the blunt distal end408of the crimping shaft412to contact the wall between the patient's LA and CS, or the patient's AS, before the puncture element414is translated forward to make contact with the wall between the patient's LA and CS, or the patient's AS. In certain embodiments, the telescoping feature of the ablation assembly406allows for a safe delivery of the puncture element414to the target location.

According to certain embodiments, the ablation assembly406of the shunting catheter400has a first deployment state (for example, shown inFIG.4A), a second deployment state (for example, shown inFIG.4B), and a third deployment state (for example, shown inFIG.4C). In some embodiments, at the first deployment state the ablation mechanism413and the puncture element414are retracted in a lumen of the crimping shaft412. In certain embodiments, at the first deployment state a plurality of positioning elements416and a plurality of expandable struts418of the ablation mechanism413(shown inFIGS.4C) and the puncture element414are retracted in the lumen of the crimping shaft412. In some embodiments, at the second deployment state the ablation mechanism413and the puncture element414are partially extended from a distal end408of the crimping shaft412. In certain embodiments, at the second deployment state the plurality of positioning elements416of the ablation mechanism413and the puncture element414are extended from the distal end408of the crimping shaft412, and the plurality of expandable struts418of the ablation mechanism413are retracted in the lumen of the crimping shaft412. In some embodiments, at the third deployment state the ablation mechanism413and the puncture element414are further extended from the distal end408of the crimping shaft412. In certain embodiments, at the third deployment state the plurality of positioning elements416and the plurality of expandable struts418of the ablation mechanism413and the puncture element414are extended from the distal end408of the crimping shaft412.

In certain embodiments, the shaft opening403includes an edge defining an opening axis411. In some embodiments, the opening axis411may be generally perpendicular to a first axis407along the catheter shaft402. In some embodiments, the distance (d3) between the opening axis411and a second axis409along the ablation assembly406may be from about 0 mm to about 20 mm.

FIG.5is a schematic diagram of a view of an example of an expandable ablation assembly500, in accordance with embodiments of the present disclosure. In certain embodiments, the ablation assembly500may include a puncture element502and an ablation mechanism504. In some embodiments, the puncture element502may be configured to puncture an opening at a target location in a patient, such as a vessel wall, more specifically the wall between the CS and LA of the patient, or the AS of the patient. In certain embodiments, the ablation mechanism504has a length in a range of 3 mm to 20 mm when fully expanded. In certain embodiments, the ablation mechanism504has an expanded diameter in a range of 2 mm to 12 mm at a cage514and 4 mm to 30 mm at positioning elements522.

According to some embodiments, the puncture element502(for example, a needle) may take on many different needle configurations. Configurations for the puncture element502may include, but not are not limited to, regular trocar point, regular taper point, regular taper cutting, regular reverse cutting edge, regular diamond point, regular conventual cutting edge, regular blunt taper point, premium lancet point, premium diamond point, and/or premium cutting edge. In certain embodiments, the puncture element502is made of materials including nitinol, stainless steel, cobalt chromium, aluminum, and/or a combination thereof. In certain embodiments, the puncture element502physically contacts tissue to puncture an opening at the target location in the patient. In certain embodiments, the puncture element502receives energy from an energy source and delivers ablation energy (such as radiofrequency (RF) energy, phased RF energy, cryogenic energy, thermal energy, pulse energy, laser energy, ultrasound energy, microwave energy, and/or the like) to tissue to puncture an opening at the target location in the patient.

In certain embodiments, the ablation mechanism504and the puncture element502are together slidable into and out of a lumen of a crimping shaft512. In certain embodiments, after the puncture element502forms an opening in the tissue at a target location in a patient, the ablation mechanism504expands to enlarge the opening in the tissue. In some embodiments, the ablation mechanism504then receives energy from an energy source and delivers ablation energy (such as radiofrequency (RF) energy, phased RF energy, cryogenic energy, thermal energy, pulse energy, laser energy, ultrasound energy, microwave energy, and/or the like) to ablate the tissue and thereby solidify the opening at the target location.

In some embodiments, the ablation mechanism504includes an expandable cage514, and the expandable cage514is fixedly coupled at its proximal end to the puncture element502. In certain embodiments, the expandable cage514includes an open distal end516(that is, being disposed apart from the puncture element502). In certain embodiments, the expandable cage514is made of one or more materials that facilitate self-expansion, such as nitinol, or one or more other materials, such as stainless steel, titanium, platinum-iridium, or cobalt-chromium.

In certain embodiments and as illustrated, the expandable cage514includes a plurality of expandable struts518. In some embodiments, the struts518are collapsed radially inwardly, or toward each other, when the ablation mechanism504is disposed in the crimping shaft512(that is, in a first state; not specifically illustrated). In certain embodiments, the struts518expand radially outwardly, or away from each other, when the ablation mechanism is disposed outside of the crimping shaft512(that is, in a second state, as illustrated inFIG.5). In certain embodiments, the expandable cage514includes two, three, four, five, six, seven, eight, nine, ten, or more expandable struts518. In certain embodiments and as illustrated, the struts518are self-expanding (for example, by being made of a shape memory material and set in the expanded state). In certain embodiments, the self-expansion of the struts518may be controlled by a constrainer, such as a plurality of sutures (for example, thin strands) coupled to the struts518. Such a constrainer may be reconfigured from a constraining state to a release state to permit the struts518to expand, and the constrainer may be reconfigured from the release state to the constraining state to collapse the struts518. In some embodiments, the constrainer may be coupled to distal ends of the struts. In certain embodiments, the struts518are expanded by an actuator, such as an inflatable balloon (not shown). In certain embodiments, an actuator may be disposed in a cavity of the cage514formed between the struts518. In certain embodiments, one or more additional components, such as control wires coupled to the actuators, may be disposed in the cavity of the cage514and extend through the ablation shaft508.

In certain embodiments and as illustrated, the expandable cage514includes a plurality of connector struts520. In some embodiments, each connector strut520is disposed between and couples adjacent expandable struts518. In certain embodiments, the connector struts520are integrally formed with the expandable struts518.

In some embodiments, the ablation mechanism504further includes a plurality of positioning elements522coupled to and disposed distally relative to the expandable struts518. In certain embodiments, the positioning elements522are disposed outwardly from the expandable cage514, or radially outwardly from the expandable struts518, relative to a longitudinal axis524defined by the puncture element502, at a second state (for example, as shown inFIG.5). In some embodiments, the positioning elements522contact tissue at a target location of a patient and thereby properly position the ablation mechanism504at the target location of the patient. In certain embodiments, one or more of the positioning elements522includes a curved shape. In some embodiments, one or more of the positioning elements522more specifically includes a curved distal end526that defines a soft landing zone configured to atraumatically contact tissue at the target location of the patient.

In certain embodiments, the expandable cage514includes two, three, four, five, six, seven, eight, nine, ten, or more positioning elements522. In some embodiments, the ablation mechanism504includes the same number of expandable struts518and positioning elements522, more specifically each expandable strut518couples to a single positioning element522. In some embodiments, the ablation mechanism504includes fewer positioning elements522than expandable struts518, more specifically one or more expandable struts518do not couple to a positioning element522.

In certain embodiments, the positioning elements522are constructed of a flexible material. In some embodiments, the positioning elements522are constructed of one or more materials that facilitate self-expansion, such as nitinol, or one or more other materials, such as stainless steel, titanium, platinum-iridium, cobalt-chromium, or flexible plastics. In certain embodiments, one or more of the positioning elements522are each integrally formed with one of the expandable struts518and constructed of the same material(s) as the expandable cage514.

In some embodiments, one or more of the expandable struts518contact tissue at a target location within a patient and act as electrodes to deliver ablation energy to the tissue. In certain embodiments, one or more portions of the ablation mechanism504may carry an insulator528(such as a heat shrink tube, a polytetrafluoroethylene (PTFE) coating, an expanded polytetrafluoroethylene (ePTFE) coating, a polyimide coating, or the like) to inhibit delivery of ablation energy to the blood of the patient. In some embodiments, the insulator528covers proximal portions of one or more of the expandable struts518and/or the positioning elements522. In certain embodiments, the insulator528may be coupled to the expandable cage514and the positioning elements522in a dip coating process. In some embodiments, the expandable cage514and the positioning elements522may be completely coated by the insulator528, and the insulator528may then be removed from portions of the expandable cage514intended to deliver ablation energy. In certain embodiments, portions of the expandable cage514intended to deliver ablation energy may first be masked, the remainder of the expandable cage514and the positioning elements522may be coated by the insulator528, and the mask may then be removed from the expandable cage514. In certain embodiments, the insulator528may have a thickness in a range of 0.0005 inches to 0.008 inches, more specifically about 0.004 inches. In alternative embodiments, the expandable cage514carries an electrode structure, such as a thin film electrode, including one or more electrodes (not shown) for delivering ablation energy to the tissue of the patient. In certain embodiments, one or more lead wires (not shown) couple the expandable cage514or the electrode structure to an energy source. In some embodiments, the lead wires may extend through the crimping shaft512or outside of the crimping shaft512.

In certain embodiments and as illustrated, the ablation mechanism504further includes one or more temperature sensors530. In some embodiments, the temperature sensors530facilitate monitoring and/or controlling ablation, for example, by notifying a user and/or automatically inhibiting delivery of ablation energy upon detecting relatively high ablation temperatures. In some embodiments, the temperature sensors530may be thermocouples (type K thermocouples, type T thermocouples, or the like), resistance temperature detectors (RTDs), negative temperature coefficient (NTC) thermistors, semiconductor-based sensors, other types of thermistors, or the like. In certain embodiments, one or more lead wires532couple the temperature sensors530to a controller. In some embodiments, one or more of the lead wires532may extend through the insulators528to couple the temperature sensors530to the expandable cage514. In certain embodiments, the temperature sensors530are trapped by the insulators528to couple the sensors530to the expandable cage514. In some embodiments, the temperature sensors530are coupled to the expandable cage514via an adhesive, for example, an epoxy or a UV light-cured adhesive. In certain embodiments, one or more of the lead wires532may extend through and/or the temperature sensors530may be positioned in structures of the expandable cage514, for example, “loops” (not shown), to couple the temperature sensors530to the expandable cage514. In some embodiments, the ablation mechanism504includes various numbers of temperature sensors530, such as one, two, three, four, five, or six temperature sensors530. In certain embodiments, one or more of the temperature sensors530has a size between 46 and 22 AWG.

FIGS.6A-6Bare schematic diagrams of side views of examples of puncture elements600A and600B of ablation assemblies, in accordance with embodiments of the present disclosure. In certain embodiments, the puncture elements600A and600B are made of materials including nitinol, stainless steel, cobalt chromium, aluminum, and/or a combination thereof. In certain embodiments, the puncture elements600A and600B may have outer diameters in a range of 0.02 in. to 0.08 in., more specifically about 0.07 in. In some embodiments, the puncture elements600A and600B may be coupled to pull wires (not shown) to facilitate bending and steering.

According to some embodiments, for example as shown inFIG.6A, the puncture element600A has a rounded tip shape. In certain embodiments, the puncture element600A has a hemispherical tip shape. Such a tip shape may facilitate delivering ablation energy (such as radiofrequency (RF) energy, phased RF energy, cryogenic energy, thermal energy, pulse energy, laser energy, ultrasound energy, microwave energy, and/or the like) to ablate tissue at a target location within a patient (for example, the wall between the patient's LA and CS, or the patient's AS).

According to some embodiments, for example as shown inFIG.6B, the puncture element600B has a pointed tip shape. In certain embodiments, the puncture element600B includes a regular trocar pointed shape. Such a tip shape may facilitate physically contacting tissue to puncture an opening at a target location within a patient (for example, the wall between the patient's LA and CS, or the patient's AS).

FIG.7is a schematic diagram of a perspective view of an example of an inner member700of an ablation shaft, in accordance with embodiments of the present disclosure. In some embodiments, the inner member700is coupled to a puncture element and/or an ablation mechanism (not shown). In certain embodiments, the inner member700is made of materials including nitinol, stainless steel, cobalt chromium, aluminum, and/or a combination thereof. In certain embodiments, the inner member700is bendable and steerable via one or more pull wires (not shown). In some embodiments, to facilitate such bending and steering, the inner member700may be hollow and include a plurality of ribs702separated by voids704. In alternative embodiments, the inner member700may have a different structure.

FIG.8is a schematic diagram of a side view of an example of an ablation mechanism pattern800including an expandable cage802and positioning elements804, in accordance with embodiments of the present disclosure, which may be used to program a laser to cut a tube (not shown), such as a metal tube, into an appropriate shape. In certain embodiments, the tube is constructed of one or more materials that facilitate self-expansion, such as nitinol, or one or more other materials, such as stainless steel, titanium, platinum-iridium, or cobalt-chromium. In certain embodiments, the ablation mechanism pattern800includes a proximal collar805for coupling to an ablation shaft.

According to certain embodiments, the expandable cage802includes a plurality of expandable struts806. In certain embodiments and as illustrated, the expandable cage802includes six expandable struts806, one of the struts806being divided into two halves in the pattern800. In other embodiments, the expandable cage802includes a different number of expandable struts806, such as two, three, four, five, seven, eight, nine, ten, or more expandable struts806.

In some embodiments, the expandable struts806are collapsed radially inwardly, or toward each other, when the tube formed using the ablation mechanism pattern800is disposed in a crimping shaft (that is, in a first state; not specifically illustrated). In certain embodiments, the struts806expand radially outwardly, or away from each other, when the tube formed using the ablation mechanism pattern800is disposed outside of the crimping shaft (that is, in a second state, not specifically illustrated). In certain embodiments and as illustrated, the struts806are self-expanding. In certain embodiments, the self-expansion of the struts806may be controlled by a constrainer, such as a plurality of sutures (for example, thin strands) coupled to the struts806. Such a constrainer may be reconfigured from a constraining state to a release state to permit the struts806to expand, and the constrainer may be reconfigured from the release state to the constraining state to collapse the struts806. In some embodiments, the constrainer may be coupled to distal ends of the struts. In certain embodiments, the struts806are expanded by an actuator, such as an inflatable balloon (not shown). In certain embodiments, an actuator may be disposed in a cavity of the cage802formed between the struts806. In certain embodiments, one or more additional components, such as control wires coupled to the actuators, may be disposed in the cavity of the cage802.

In certain embodiments and as illustrated, the expandable cage802includes a plurality of connector struts808. In some embodiments, each connector strut808is disposed between and couples adjacent expandable struts806. In certain embodiments, the connector struts808are integrally formed with the expandable struts806.

In some embodiments, the ablation mechanism pattern800further includes the positioning elements804, which are coupled to and disposed distally relative to the expandable struts806. In certain embodiments, the positioning elements804are disposed outwardly from the expandable cage802, or radially outwardly from the expandable struts806, relative to a longitudinal axis defined by the ablation shaft, at a second state (not specifically illustrated). In some embodiments, the positioning elements804contact tissue at a target location of a patient and thereby properly position the tube formed using the ablation mechanism pattern800at the target location of the patient.

In certain embodiments, the expandable cage802includes two, three, four, five, six, seven, eight, nine, ten, or more positioning elements804. In some embodiments, the ablation mechanism pattern800includes the same number of expandable struts806and positioning elements804, more specifically each expandable strut806couples to a single positioning element804. In some embodiments, the ablation mechanism pattern800includes fewer positioning elements804than expandable struts806, more specifically one or more expandable struts806do not couple to a positioning element804.

In certain embodiments, the positioning elements804are constructed of a flexible material. In some embodiments, the positioning elements804are constructed of one or more materials that facilitate self-expansion, such as nitinol, or one or more other materials, such as stainless steel, titanium, platinum-iridium, cobalt-chromium, or flexible plastics. In certain embodiments, one or more of the positioning elements804are each integrally formed with one of the expandable struts806and constructed of the same material(s) as the expandable cage802. In some embodiments, one or more of the positioning elements804are constructed of or include a radiopaque material.

In some embodiments, one or more of the expandable struts806contact tissue at a target location within a patient and act as electrodes to deliver ablation energy to the tissue. In certain embodiments, one or more portions of the tube formed by the ablation mechanism pattern800may carry an insulator (not shown; such as a heat shrink tube, a polytetrafluoroethylene (PTFE) coating, an expanded polytetrafluoroethylene (ePTFE) coating, a polyimide coating, or the like) to inhibit delivery of ablation energy to the blood of the patient. In some embodiments, the insulation is applied onto the electrode through the manufacturing method of dip coated, spray coating, electrospinning, lamination, heat shrinkage, or the like. In some embodiments, the insulator covers proximal portions of one or more of the expandable struts806and/or the positioning elements804. In certain embodiments, the expandable cage802and/or the positioning elements804may include anchor structures that facilitate coupling to the insulator. In some embodiments and as illustrated, one or more of the expandable struts806and one or more of the positioning elements804include apertures810to facilitate coupling to the insulator. In certain embodiments and as illustrated, one or more of the positioning elements804include protrusions812to facilitate coupling to the insulator. In some embodiments, additional or alternative features couple the insulator to the ablation mechanism, such as sutures and/or adhesives. In certain embodiments, the insulator may have a thickness in a range of 0.0005 inches to 0.008 inches, more specifically about 0.004 inches. In alternative embodiments, the expandable cage802carries an electrode structure, such as a thin film electrode, including one or more electrodes (not shown) for delivering ablation energy to the tissue of the patient. In certain embodiments, one or more lead wires (not shown) couple the expandable cage802or the electrode structure to an energy source. In some embodiments, the lead wires may extend through the crimping shaft or outside of the crimping shaft.

FIGS.9A-9Bare schematic diagrams of side views of examples of positioning elements900A and900B of ablation assemblies, in accordance with embodiments of the present disclosure. In certain embodiments, the positioning elements900A and900B form part of ablation mechanisms (not shown). In some embodiments, the positioning elements900A and900B are coupled to expandable cages (not shown) of ablation mechanisms. In certain embodiments, the positioning elements900A and900B are integrally formed with and constructed of the same material as expandable cages of ablation mechanisms.

In certain embodiments, one or more portions of the positioning elements900A and900B carry an insulator (not shown; such as a heat shrink tube, a polytetrafluoroethylene (PTFE) coating, an expanded polytetrafluoroethylene (ePTFE) coating, a polyimide coating, or the like) to inhibit delivery of ablation energy to the blood of the patient. In certain embodiments, the positioning elements900A and900B include anchor structures that facilitate coupling to the insulator. According to some embodiments, for example as shown inFIG.9A, the positioning element900A includes one or more protrusions902to facilitate coupling to the insulator. According to some embodiments, for example as shown inFIG.9B, the positioning element900B includes and one or more indentations904to facilitate coupling to the insulator. In certain embodiments, the positioning elements900A and900B carry one or more radiopaque markers (not shown) to facilitate visualization of the positioning elements900A and900B under fluoroscopy. In some embodiments, the one or more radiopaque markers are constructed of platinum, platinum-iridium, gold, tantalum, palladium, or the like. In certain embodiments, the one or more radiopaque markers can ball-shaped, puck-shaped, wires, ribbons, or the like. In some embodiments, the one or more radiopaque markers are coupled to the positioning elements900A and900B via coining/press fitting, welding, adhesives, or the like. In certain embodiments, the one or more radiopaque markers are coupled to the positioning elements900A and900B by being covered by the insulator. In some embodiments, the positioning elements900A and900B include one or more apertures906for receiving the radiopaque markers.

FIGS.10A and10Bare schematic diagrams of side views of an example of an ablation mechanism1000including an expandable cage1002and positioning elements1004, in accordance with embodiments of the present disclosure. In certain embodiments, the ablation mechanism1000is constructed of one or more materials that facilitate self-expansion, such as nitinol, or one or more other materials, such as stainless steel, titanium, platinum-iridium, or cobalt-chromium. In certain embodiments, the ablation mechanism1000includes a proximal collar (not shown) for coupling to an ablation shaft.

According to certain embodiments, the expandable cage1002includes a plurality of expandable struts1006. In certain embodiments and as illustrated, the expandable cage1002includes six expandable struts1006(three of the struts1006being at least partially obscured inFIGS.10A-10B). In other embodiments, the expandable cage1002includes a different number of expandable struts1006, such as two, three, four, five, seven, eight, nine, ten, or more expandable struts1006.

In some embodiments, the expandable struts1006are collapsed radially inwardly, or toward each other, when the ablation mechanism1000is disposed in a crimping shaft (that is, in a first state; not specifically illustrated). In certain embodiments, the struts1006expand radially outwardly, or away from each other, when the ablation mechanism1000is disposed outside of the crimping shaft (that is, in a second state, not specifically illustrated). In certain embodiments and as illustrated, the struts1006are self-expanding. In certain embodiments, the self-expansion of the struts1006may be controlled by a constrainer, such as a plurality of sutures (for example, thin strands) coupled to the struts1006. Such a constrainer may be reconfigured from a constraining state to a release state to permit the struts1006to expand, and the constrainer may be reconfigured from the release state to the constraining state to collapse the struts1006. In some embodiments, the constrainer may be coupled to distal ends of the struts1006. In certain embodiments, the struts1006are expanded by an actuator, such as an inflatable balloon (not shown). In certain embodiments, an actuator may be disposed in a cavity of the cage1002formed between the struts1006. In certain embodiments, one or more additional components, such as control wires coupled to the actuators, may be disposed in the cavity of the cage1002.

In certain embodiments and as illustrated, the expandable cage1002includes a plurality of connector struts1008. In some embodiments, each connector strut1008is disposed between and couples adjacent expandable struts1006. In certain embodiments, the connector struts1008are integrally formed with the expandable struts1006.

In some embodiments, the ablation mechanism1000further includes the positioning elements1004, which are coupled to and disposed distally relative to the expandable struts1006. In certain embodiments, the positioning elements1004are disposed outwardly from the expandable cage1002, or radially outwardly from the expandable struts1006, relative to a longitudinal axis1011defined by the ablation shaft. In some embodiments, the positioning elements1004contact tissue1012(FIG.10B) at a target location of a patient and thereby properly position the ablation mechanism1000at the target location of the patient. In certain embodiments, one or more of the positioning elements1004includes a curved shape. In some embodiments, one or more of the positioning elements1004more specifically includes a curved distal end1014that defines a soft landing zone configured to atraumatically contact tissue at the target location of the patient.

In certain embodiments, the expandable cage1002includes two, three, four, five, six, seven, eight, nine, ten, or more positioning elements1004. In some embodiments, the ablation mechanism1000includes the same number of expandable struts1006and positioning elements1004, more specifically each expandable strut1006couples to a single positioning element1004. In some embodiments, the ablation mechanism1000includes fewer positioning elements1004than expandable struts1006, more specifically one or more expandable struts1006do not couple to a positioning element1004.

In certain embodiments, the positioning elements1004are constructed of a flexible material. In some embodiments, the positioning elements1004are constructed of one or more materials that facilitate self-expansion, such as nitinol, or one or more other materials, such as stainless steel, titanium, platinum-iridium, cobalt-chromium, or flexible plastics. In certain embodiments, one or more of the positioning elements1004are each integrally formed with one of the expandable struts1006and constructed of the same material(s) as the expandable cage1002. In some embodiments, one or more of the positioning elements1004are constructed of or include a radiopaque material.

In some embodiments, one or more of the expandable struts1006contact tissue at a target location within a patient and act as electrodes to deliver ablation energy to the tissue. In certain embodiments, one or more portions of the ablation mechanism1000may carry an insulator (not shown; such as a heat shrink tube, a polytetrafluoroethylene (PTFE) coating, an expanded polytetrafluoroethylene (ePTFE) coating, a polyimide coating, or the like) to inhibit delivery of ablation energy to the blood of the patient. In some embodiments, the insulator covers proximal portions of one or more of the expandable struts1006and/or the positioning elements1004. In certain embodiments, the expandable cage1002and/or the positioning elements1004may include anchor structures that facilitate coupling to the insulator. In alternative embodiments, the expandable cage1002carries an electrode structure, such as a thin film electrode, including one or more electrodes (not shown) for delivering ablation energy to the tissue of the patient. In certain embodiments, one or more lead wires (not shown) couple the expandable cage1002or the electrode structure to an energy source. In some embodiments, the lead wires may extend through the crimping shaft or outside of the crimping shaft.

In certain embodiments, one or more expandable struts1006are offset from one or more other expandable struts1006relative to the longitudinal axis1011, one or more connector struts1008are offset from one or more other connector struts1008relative to the longitudinal axis1011, and/or one or more positioning elements1004are offset from one or more other positioning elements1004relative to the longitudinal axis1011. In some embodiments, the offset distance is in a range of 0.04 inches to 0.20 inches. In certain embodiments and as illustrated inFIG.10A, the distal ends1014of one or more positioning elements1004define a first angle1016relative to the longitudinal axis1011, the distal ends1014of one or more other positioning elements1004define a second angle1018relative to the longitudinal axis1011, and the first angle1016is different than the second angle1018. In some embodiments, the first angle1016is in a range of 45 degrees to 90 degrees. In some embodiments, the second angle1018is in a range of 90 degrees to 135 degrees. In certain embodiments and instances, and as shown specifically inFIG.10B, such longitudinal and/or angular offsets facilitate increased contact and improved seating of the ablation mechanism1000against the tissue1012of a patient.

FIGS.11A and11Bare schematic diagrams of side views of examples of ablation mechanism patterns1100A and1100B including expandable cages1102A and1102B, respectively, and positioning elements1104A and1104B, respectively, in accordance with embodiments of the present disclosure, which may be used to program a laser to cut tubes (not shown), such as metal tubes, into an appropriate shape. In certain embodiments, the tubes are constructed of one or more materials that facilitate self-expansion, such as nitinol, or one or more other materials, such as stainless steel, titanium, platinum-iridium, or cobalt-chromium. In certain embodiments, the ablation mechanism patterns1100A and1100B include proximal collars1105A and1105B, respectively, for coupling to ablation shafts.

According to certain embodiments, the expandable cages1102A and1102B include pluralities of expandable struts1106A and1106B, respectively. In certain embodiments and as illustrated, the expandable cages1102A and1102B includes six expandable struts1106A and1106B, respectively, one of each of the struts1106A and1106B being divided into two halves during manufacturing. In other embodiments, the expandable cages1102A and1102B include different numbers of expandable struts1106A and1106B, respectively, such as two, three, four, five, seven, eight, nine, ten, or more expandable struts1106A and1106B.

In some embodiments, the expandable struts1106A and1106B are collapsed radially inwardly, or toward each other, when the tubes formed using the ablation mechanisms1100A and1100B, respectively, are disposed in crimping shafts (that is, in first states; not specifically illustrated). In certain embodiments, the struts1106A and1106B expand radially outwardly, or away from each other, when the ablation mechanisms1100A and1100B, respectively, are disposed outside of the crimping shaft (that is, in second states, not specifically illustrated). In certain embodiments and as illustrated, the struts1106A and1106B are self-expanding. In certain embodiments, the self-expansion of the struts1106A and1106B may be controlled by a constrainer, such as a plurality of sutures (for example, thin strands) coupled to the struts1106A and1106B. Such a constrainer may be reconfigured from a constraining state to a release state to permit the struts1106A and1106B to expand, and the constrainer may be reconfigured from the release state to the constraining state to collapse the struts1106A and1106B. In some embodiments, the constrainer may be coupled to distal ends of the struts. In certain embodiments, the struts1106A and1106B are expanded by an actuator, such as an inflatable balloon (not shown). In certain embodiments, actuators may be disposed in cavities of the cages1102A and1102B formed between the struts1106A and1106B, respectively. In certain embodiments, one or more additional components, such as control wires coupled to the actuators, may be disposed in the cavities of the cages1102A and1102B.

In certain embodiments and as illustrated, the expandable cages1102A and1102B include a plurality of connector struts1108A and1108B, respectively. In some embodiments, each connector strut1108A and1108B is disposed between and couples adjacent expandable struts1106A and1106B, respectively. In certain embodiments, the connector struts1108A and1108B are integrally formed with the expandable struts1106A and1106B, respectively.

In some embodiments, the ablation mechanism patterns1100A and1100B further include the positioning elements1104A and1104B, respectively, which are coupled to and disposed distally relative to the expandable struts1106A and1106B, respectively. In certain embodiments, the positioning elements1104A and1104B are disposed outwardly from the expandable cages1102A and1102B, respectively, or radially outwardly from the expandable struts1106A and1106B, respectively, relative to longitudinal axes defined by the ablation shafts, at second states (not specifically illustrated). In some embodiments, the positioning elements1104A and1104B contact tissue at a target location of a patient and thereby properly position the tubes formed using the ablation mechanisms1100A and1100B, respectively, at the target location of the patient.

In certain embodiments, the expandable cages1102A and1102B includes two, three, four, five, six, seven, eight, nine, ten, or more positioning elements1104A and1104B, respectively. In some embodiments, the ablation mechanism patterns1100A and1100B include the same number of expandable struts1106A and1106B, respectively, and positioning elements1104A and1104B, respectively, more specifically each expandable strut1106A and1106B couples to a single positioning element1104A and1104B, respectively. In some embodiments, the ablation mechanism patterns1100A and1100B include fewer positioning elements1104A and1104B, respectively, than expandable struts1106A and1106B, respectively, more specifically one or more expandable struts1106A and1106B do not couple to positioning elements1104A and1104B, respectively.

In some embodiments, one or more of the positioning elements1104A and1104B are constructed of or include a radiopaque material. In certain embodiments, the positioning elements1104A and1104B carry one or more radiopaque markers (not shown) to facilitate visualization of the positioning elements1104A and1104B under fluoroscopy. In some embodiments, the one or more radiopaque markers are constructed of platinum, platinum-iridium, gold, tantalum, palladium, or the like. In certain embodiments, the one or more radiopaque markers can ball-shaped, puck-shaped, wires, ribbons, or the like. In some embodiments, the one or more radiopaque markers are coupled to the positioning elements1104A and1104B via coining/press fitting, welding, adhesives, or the like. In certain embodiments, the one or more radiopaque markers are coupled to the positioning elements1104A and1104B by being covered by the insulator. In some embodiments, the positioning elements1104A and1104B include one or more apertures1107A and1107B, respectively, for receiving the radiopaque markers.

In certain embodiments, one or more of the positioning elements1104A and1104B have different lengths than one or more other positioning elements1104A and1104B (in both the flat initial configurations and subsequent curved configurations) to facilitate increased contact and improved seating of the tubes formed using the ablation mechanism patterns1100A and1100B against the tissue of a patient. For example and referring specifically toFIG.11A, in some embodiments the ablation mechanism pattern1100A includes a first group of adjacent positioning elements1104AA having a first length and a second group of adjacent positioning elements1104AB having a second length, and the second length is greater than the first length. As another example and referring specifically toFIG.11B, in some embodiments the ablation mechanism pattern1100B includes a first group of adjacent positioning elements1104BA with different lengths and a second group of adjacent positioning elements1104BB with different lengths. In certain embodiments, in each group of positioning elements1104BA and1104BB one or more positioning elements has a first length, one or more positioning elements has a second length, and the second length is greater than the first length.

In some embodiments, one or more of the expandable struts1106A and1106B contact tissue at a target location within a patient and act as electrodes to deliver ablation energy to the tissue. In certain embodiments, one or more portions of the tubes formed using the ablation mechanism patterns1100A and1100B may carry insulators (not shown; such as a heat shrink tube, a polytetrafluoroethylene (PTFE) coating, an expanded polytetrafluoroethylene (ePTFE) coating, a polyimide coating, or the like) to inhibit delivery of ablation energy to the blood of the patient. In some embodiments, the insulators cover proximal portions of one or more of the expandable struts1106A and1106B and/or the positioning elements1104A and1104B. In certain embodiments, the expandable cages1102A and1102B and/or the positioning elements1104A and1104B may include anchor structures that facilitate coupling to the insulator. In certain embodiments and as illustrated, one or more of the positioning elements1104A and1104B include protrusions1112A and1112B, respectively, to facilitate coupling to the insulators. In some embodiments, additional or alternative features couple the insulators to the tubes formed using the ablation mechanism patterns1100A and1100B, such as sutures and/or adhesives. In certain embodiments, the insulators may have thicknesses in a range of 0.0005 inches to 0.008 inches, more specifically about 0.004 inches. In alternative embodiments, the expandable cages1102A and1102B carry electrode structures, such as thin film electrodes, including one or more electrodes (not shown) for delivering ablation energy to the tissue of the patient. In certain embodiments, one or more lead wires (not shown) couple the expandable cages1102A and1102B or the electrode structure to an energy source. In some embodiments, the lead wires may extend through the crimping shaft or outside of the crimping shaft.

FIGS.12A and12Bare schematic diagrams of side views of an example of an ablation mechanism1200including an expandable cage1202, positioning elements1204, and an expandable iris assembly1206, in accordance with embodiments of the present disclosure. In certain embodiments, the expandable cage1202and the positioning elements1204are constructed of one or more materials that facilitate self-expansion, such as nitinol, or one or more other materials, such as stainless steel, titanium, platinum-iridium, or cobalt-chromium. In certain embodiments, the ablation mechanism1200includes a proximal collar (not shown) for coupling to an ablation shaft.

According to certain embodiments, the expandable cage1202includes a plurality of expandable struts1208. In certain embodiments and as illustrated, the expandable cage1202includes six expandable struts1208. In other embodiments, the expandable cage1202includes a different number of expandable struts1208, such as two, three, four, five, seven, eight, nine, ten, or more expandable struts1208.

In some embodiments, the expandable struts1208are collapsed radially inwardly, or toward each other, when the ablation mechanism1200is disposed in a crimping shaft (that is, in a first state; not specifically illustrated). In certain embodiments, the struts1208expand radially outwardly, or away from each other, when the ablation mechanism1200is disposed outside of the crimping shaft (that is, in a second state and as illustrated). In certain embodiments and as illustrated, the struts1208are self-expanding. In certain embodiments, the self-expansion of the struts1208may be controlled by a constrainer, such as a plurality of sutures (for example, thin strands) coupled to the struts1208. Such a constrainer may be reconfigured from a constraining state to a release state to permit the struts1208to expand, and the constrainer may be reconfigured from the release state to the constraining state to collapse the struts1208. In some embodiments, the constrainer may be coupled to distal ends of the struts1208. In certain embodiments, the struts1208are expanded by an actuator, such as an inflatable balloon (not shown). In certain embodiments, an actuator may be disposed in a cavity of the cage1202formed between the struts1208. In certain embodiments, one or more additional components, such as control wires coupled to the actuators, may be disposed in the cavity of the cage1202.

In certain embodiments and as illustrated, the expandable cage1202includes a plurality of connector struts1210. In some embodiments, each connector strut1208is disposed between and couples adjacent expandable struts1208. In certain embodiments, the connector struts1210are integrally formed with the expandable struts1208.

In some embodiments, the ablation mechanism1200further includes the positioning elements1204, which are coupled to and disposed distally relative to the expandable struts1208. In certain embodiments, the positioning elements1204are disposed outwardly from the expandable cage1202, or radially outwardly from the expandable struts1208, relative to a longitudinal axis1212defined by the ablation shaft. In some embodiments, the positioning elements1204contact tissue at a target location of a patient and thereby properly position the ablation mechanism1200at the target location of the patient.

In certain embodiments, the ablation mechanism1200includes two, three, four, five, six, seven, eight, nine, ten, or more positioning elements1204. In some embodiments and as illustrated, the ablation mechanism1200includes one or more positioning elements1204that each couple to two expandable struts1208and form a portion of a loop therebetween. In certain embodiments, one or more of the positioning elements1204includes a curved shape. In some embodiments, one or more of the positioning elements1204more specifically includes a curved distal end1214that defines a soft landing zone configured to atraumatically contact tissue at the target location of the patient. In some embodiments, the ablation mechanism1200includes a different number and/or arrangement of positioning elements1204.

In certain embodiments, the expandable iris assembly1206is disposed radially outwardly from the plurality of expandable struts1208relative to the longitudinal axis1212. In some embodiments, the iris assembly1206includes a plurality of relatively movable iris elements1216disposed radially outwardly from the expandable struts1208and the connector struts1210. In certain embodiments, the iris elements1216are collapsed radially inwardly, or toward each other, when the ablation mechanism1200is disposed in the crimping shaft (that is, in the first state; not specifically illustrated). In some embodiments, the iris elements1216move relative to each other, more specifically slide past each other, and extend radially outwardly when the ablation mechanism1200is disposed outside of the crimping shaft (that is, when moving the second state, as illustrated).

In certain embodiments and as illustrated, the expandable iris assembly1206includes six iris elements1216. In some embodiments, the expandable iris assembly1206includes a different number of iris elements1216, such as two, three, four, five, seven, eight, nine, ten, or more iris elements1216. In certain embodiments, the iris elements1216are constructed of one or more of various materials, such as nitinol, stainless steel, titanium, platinum-iridium, cobalt-chromium, plastics, or the like.

In some embodiments, the iris assembly1206carries an electrode structure (not shown), such as a thin film electrode, including one or more electrodes, for delivering ablation energy to the tissue of the patient. In some embodiments, one or more of the iris elements1216carries an electrode structure on its outer surface. In certain embodiments, one or more conductors1218couple the electrode structure(s) to an energy source. In some embodiments, the conductors1218may extend through the crimping shaft or outside of the crimping shaft. In certain embodiments, the iris assembly1206and the electrode structure advantageously define a relatively large shunting area.

FIGS.13A and13Bare schematic diagrams of side views of an example of an ablation mechanism1300including an expandable cage1302, positioning elements1304, and an electrode array1306for delivering ablation energy to tissue of a patient, in accordance with embodiments of the present disclosure. In certain embodiments, the expandable cage1302and the positioning elements1304are constructed of one or more materials that facilitate self-expansion, such as nitinol, or one or more other materials, such as stainless steel, titanium, platinum-iridium, or cobalt-chromium. In certain embodiments, the ablation mechanism1300includes a proximal collar1305for coupling to an ablation shaft.

According to certain embodiments, the expandable cage1302includes a plurality of expandable struts1308. In certain embodiments and as illustrated, the expandable cage1302includes six expandable struts1308. In other embodiments, the expandable cage1302includes a different number of expandable struts1308, such as two, three, four, five, seven, eight, nine, ten, or more expandable struts1308.

In some embodiments, the expandable struts1308are collapsed radially inwardly, or toward each other, when the ablation mechanism1300is disposed in a crimping shaft (that is, in a first state; not specifically illustrated). In certain embodiments, the struts1308expand radially outwardly, or away from each other, when the ablation mechanism1300is disposed outside of the crimping shaft (that is, in a second state and as illustrated). In certain embodiments and as illustrated, the struts1308are self-expanding. In certain embodiments, the self-expansion of the struts1308may be controlled by a constrainer, such as a plurality of sutures (for example, thin strands) coupled to the struts1308. Such a constrainer may be reconfigured from a constraining state to a release state to permit the struts1308to expand, and the constrainer may be reconfigured from the release state to the constraining state to collapse the struts1308. In some embodiments, the constrainer may be coupled to distal ends of the struts1308. In certain embodiments, the struts1308are expanded by an actuator, such as an inflatable balloon (not shown). In certain embodiments, an actuator may be disposed in a cavity of the cage1302formed between the struts1308. In certain embodiments, one or more additional components, such as control wires coupled to the actuators, may be disposed in the cavity of the cage1302.

In certain embodiments and as illustrated, the expandable cage1302includes a plurality of connector struts1310. In some embodiments, each connector strut1308is disposed between and couples adjacent expandable struts1308. In certain embodiments, the connector struts1310are integrally formed with the expandable struts1308.

In some embodiments, the ablation mechanism1300further includes the positioning elements1304, which are coupled to and disposed distally relative to the expandable struts1308. In certain embodiments, the positioning elements1304are disposed outwardly from the expandable cage1302, or radially outwardly from the expandable struts1308, relative to a longitudinal axis1312defined by the ablation shaft. In some embodiments, the positioning elements1304contact tissue at a target location of a patient and thereby properly position the ablation mechanism1300at the target location of the patient.

In certain embodiments, the ablation mechanism1300includes two, three, four, five, six, seven, eight, nine, ten, or more positioning elements1304. In some embodiments and as illustrated, the ablation mechanism1300includes one or more positioning elements1304that each couple to two expandable struts1308and form a portion of a loop therebetween. In certain embodiments, one or more of the positioning elements1304includes a curved shape. In some embodiments, one or more of the positioning elements1304more specifically includes a curved distal end1314that defines a soft landing zone configured to atraumatically contact tissue at the target location of the patient. In some embodiments, the ablation mechanism1300includes a different number and/or arrangement of positioning elements1304.

In certain embodiments, the electrode array1306is disposed radially outwardly from the plurality of expandable struts1308relative to the longitudinal axis1312. In some embodiments, the electrode array1306includes a plurality of electrodes1316disposed radially outwardly from the expandable struts1308. In some embodiments, the electrodes1316are electrode ribbons. In certain embodiments, the electrodes1316move together with the expandable struts1308. In some embodiments, the electrodes1316may be coupled to the expandable struts1308in various manners, such as via lamination, epoxies, adhesives, or the like. In some embodiments, the electrodes1316are collapsed radially inwardly, or toward each other, when the ablation mechanism1300is disposed in the crimping shaft (that is, in the first state; not specifically illustrated). In some embodiments, the electrodes1316extend radially outwardly when the ablation mechanism1300is disposed outside of the crimping shaft (that is, in the second state, as illustrated).

In certain embodiments and as illustrated, the electrode array1306includes six electrodes1316. In some embodiments, the electrode array1306includes a different number of electrodes1316, such as two, three, four, five, seven, eight, nine, ten, or more electrodes1316. In certain embodiments and as illustrated, each expandable strut1308couples to a single electrode1316. In some embodiments, one or more of the expandable struts1308do not couple to an electrode1316. In certain embodiments, one or more conductors1318couple the electrodes1316to an energy source. In some embodiments, the conductors1318may extend through the crimping shaft or outside of the crimping shaft. In certain embodiments, the electrode array1306advantageously provides relatively high energy efficiency and relatively low power consumption.

FIGS.14A and14Bare schematic diagrams of side views of an example of an ablation mechanism1400including an expandable cage1402, positioning elements1404, and an electrode array1406, and an actuator1408for expanding the ablation mechanism1400, in accordance with embodiments of the present disclosure. In certain embodiments, the expandable cage1402is constructed of one or more of various materials, such as nitinol, stainless steel, titanium, platinum-iridium, or cobalt-chromium. In certain embodiments, the ablation mechanism1400includes a proximal collar1405for coupling to an ablation shaft.

According to certain embodiments, the expandable cage1402includes a plurality of expandable struts1410. In certain embodiments and as illustrated, the expandable cage1402includes ten expandable struts1410. In other embodiments, the expandable cage1402includes a different number of expandable struts1410, such as two, three, four, five, six, seven, eight, nine, eleven, or more expandable struts1410.

In some embodiments, the expandable struts1410are collapsed radially inwardly, or toward each other, when the ablation mechanism1400is disposed in a crimping shaft (that is, in a first state; not specifically illustrated). In certain embodiments, the struts1410expand radially outwardly, or away from each other, when the ablation mechanism1400is disposed outside of the crimping shaft (that is, in a second state and as illustrated). In certain embodiments, the struts1410are expanded by the actuator1408, which may be an inflatable balloon. In certain embodiments, the actuator1408is disposed in a cavity of the cage1402formed between the struts1410. In certain embodiments, one or more additional components of the actuator1408, such as an inflation fluid delivery conduit1413, may be disposed in the proximal collar1405.

In some embodiments, the ablation mechanism1400further includes the positioning elements1404, which are coupled to and disposed distally relative to the expandable struts1410. In certain embodiments, the positioning elements1404are disposed outwardly from the expandable cage1402, or radially outwardly from the expandable struts1410, relative to a longitudinal axis1415defined by the ablation shaft. In some embodiments, the positioning elements1404contact tissue at a target location of a patient and thereby properly position the ablation mechanism1400at the target location of the patient.

In certain embodiments, the ablation mechanism1400includes two, three, four, five, six, seven, eight, nine, ten, or more positioning elements1404. In some embodiments and as illustrated, each expandable strut1410couples to a single positioning elements1404. In certain embodiments, one or more of the positioning elements1404includes a curved shape. In some embodiments, one or more of the positioning elements1404more specifically includes a curved distal end1412that defines a soft landing zone configured to atraumatically contact tissue at the target location of the patient. In some embodiments, the ablation mechanism1400includes a different number and/or arrangement of positioning elements1404.

In certain embodiments, the positioning elements1404are constructed of a flexible material. In some embodiments, the positioning elements1404are constructed of a different material than the expandable cage1402. In some embodiments, the positioning elements1404are constructed of one or more materials that facilitate self-expansion, such as nitinol, or one or more other materials, such as stainless steel, titanium, platinum-iridium, cobalt-chromium, or flexible plastics. In certain embodiments, one or more of the positioning elements1404are integrally formed with the expandable struts1410and constructed of the same material(s) as the expandable cage1402. In some embodiments, one or more of the positioning elements1404are constructed of or include a radiopaque material.

In certain embodiments, the electrode array1406is disposed radially outwardly from the plurality of expandable struts1410relative to the longitudinal axis1415. In some embodiments, the electrode array1406includes a plurality of electrodes1414disposed radially outwardly from the expandable struts1410. In some embodiments, the electrodes1414are flexible electrode ribbons. In certain embodiments, the electrodes1414move together with the expandable struts1410. In some embodiments, the electrodes1414may be coupled to the expandable struts1410in various manners, such as via lamination, epoxies, adhesives, or the like. In some embodiments, the electrodes1414are collapsed radially inwardly, or toward each other, when the ablation mechanism1400is disposed in the crimping shaft (that is, in the first state; not specifically illustrated). In some embodiments, the electrodes1414extend radially outwardly when the ablation mechanism1400is disposed outside of the crimping shaft (that is, in the second state, as illustrated).

In certain embodiments and as illustrated, the electrode array1406includes ten electrodes1414. In some embodiments, the electrode array1406includes a different number of electrodes1414, such as two, three, four, five, six, seven, eight, nine, eleven, or more electrodes1414. In certain embodiments and as illustrated, each expandable strut1410couples to a single electrode1414. In some embodiments, one or more of the expandable struts1410do not couple to an electrode1414. In certain embodiments, one or more conductors (not shown) couple the electrodes1414to an energy source. In some embodiments, the conductors may extend through the crimping shaft or outside of the crimping shaft. In certain embodiments, the actuator1408provides relatively high radial support for the electrode array1406.

FIGS.15A and15Bare schematic diagrams of side views of an example of an ablation mechanism1500including an expandable cage1502, positioning elements1504, and an electrode array1506, in accordance with embodiments of the present disclosure. In certain embodiments, the ablation mechanism1500includes a proximal collar1505for coupling to an ablation shaft. In certain embodiments, the ablation mechanism1500includes a distal collar1507for coupling the expandable cage1502and the positioning elements1504. In some embodiments, the expandable cage1502, the positioning elements1504, the proximal collar1505, and the distal collar1507are integrally constructed from a laser-cut hypotube. In certain embodiments, the expandable cage1502, the positioning elements1504, the proximal collar1505, and the distal collar1507are constructed of one or more materials that facilitate self-expansion, such as nitinol, or one or more other materials, such as stainless steel, titanium, platinum-iridium, or cobalt-chromium.

According to certain embodiments, the expandable cage1502includes a plurality of expandable struts1508. In certain embodiments and as illustrated, the expandable cage1502includes ten expandable struts1508. In other embodiments, the expandable cage1502includes a different number of expandable struts1508, such as two, three, four, five, six, seven, eight, nine, eleven, or more expandable struts1508.

In some embodiments, the expandable struts1508are collapsed radially inwardly, or toward each other, when the ablation mechanism1500is disposed in a crimping shaft (that is, in a first state and as illustrated inFIG.15A). In certain embodiments, the struts1508expand radially outwardly, or away from each other, when the ablation mechanism1500is disposed outside of the crimping shaft (that is, in a second state and as illustrated inFIGS.15B and15C). In certain embodiments and as illustrated, the struts1508are self-expanding. In certain embodiments, the self-expansion of the struts1508may be controlled by a constrainer, such as a plurality of sutures (for example, thin strands) coupled to the struts1508. Such a constrainer may be reconfigured from a constraining state to a release state to permit the struts1508to expand, and the constrainer may be reconfigured from the release state to the constraining state to collapse the struts1508. In certain embodiments, the struts1508are expanded by an actuator, such as an inflatable balloon (not shown). In certain embodiments, an actuator may be disposed in a cavity of the cage1502formed between the struts1508. In certain embodiments, one or more additional components, such as control wires coupled to the actuators, may be disposed in the cavity of the cage1502.

In some embodiments, the ablation mechanism1500further includes the positioning elements1504, which are coupled to and disposed distally relative to the distal collar1507. In certain embodiments, the positioning elements1504are disposed outwardly from the expandable cage1502, or radially outwardly from the expandable struts1508, relative to a longitudinal axis1510defined by the ablation shaft. In some embodiments, the positioning elements1504contact tissue at a target location of a patient and thereby properly position the ablation mechanism1500at the target location of the patient.

In certain embodiments, the ablation mechanism1500includes ten positioning elements1504. In other embodiments, the positioning elements1504includes a different number of positioning elements1504, such as two, three, four, five, six, seven, eight, nine, eleven, or more positioning elements1504. In certain embodiments, one or more of the positioning elements1504includes a curved shape. In some embodiments, one or more of the positioning elements1504more specifically includes a curved distal end1512that defines a soft landing zone configured to atraumatically contact tissue at the target location of the patient. In some embodiments, the ablation mechanism1500includes a different number and/or arrangement of positioning elements1504.

In certain embodiments, the electrode array1506is disposed radially outwardly from the plurality of expandable struts1508relative to the longitudinal axis1510. In some embodiments, the electrode array1506includes a plurality of electrodes1514disposed radially outwardly from the expandable struts1508. In some embodiments, the electrodes1514are flexible electrode ribbons. In certain embodiments, the electrodes1514move together with the expandable struts1508. In some embodiments, the electrodes1514may be coupled to the expandable struts1508in various manners, such as via lamination, epoxies, adhesives, or the like. In some embodiments, the electrodes1514are collapsed radially inwardly, or toward each other, when the ablation mechanism1500is disposed in the crimping shaft (that is, in the first state and as shown inFIG.15A). In some embodiments, the electrodes1514extend radially outwardly when the ablation mechanism1500is disposed outside of the crimping shaft (that is, in the second state and as illustrated inFIGS.15B and15C).

In certain embodiments and as illustrated, the electrode array1506includes ten electrodes1514. In some embodiments, the electrode array1506includes a different number of electrodes1514, such as two, three, four, five, six, seven, eight, nine, eleven, or more electrodes1514. In certain embodiments and as illustrated, each expandable strut1508couples to a single electrode1514. In some embodiments, one or more of the expandable struts1508do not couple to an electrode1514. In certain embodiments, one or more conductors (not shown) couple the electrodes1514to an energy source. In some embodiments, the conductors may extend through the crimping shaft or outside of the crimping shaft.

FIG.16is a schematic diagram of a side view of an example of an electrode1600of an ablation assembly, in accordance with embodiments of the present disclosure. In some embodiments, the electrode is configured to receive energy from an energy source and deliver ablation energy to tissue at a target location in a patient. In certain embodiments, the electrode1600is a thin film electrode. In some embodiments, the electrode1600includes a thin film substrate or base1602that carries one or more conductors1604. In certain embodiments, the base1602is made of a flexible/foldable material (such as an insulating polymer, more specifically a polyimide) and is movable from a first state or compressed state to a second state or expanded state and vice versa. In some embodiments, the conductor1604is made of one or more conductive metals, such as gold, platinum-iridium, copper, or the like. According to some embodiments, the base1602carries a single conductor1604. In certain embodiments, the conductor1604includes a plurality of fingers1606that extend in opposite directions from a central portion1608.

FIGS.17A-Bare schematic diagrams of side views of an example of a shunting catheter1700, according to certain embodiments of the present disclosure.FIGS.17A-Bare merely examples. One of the ordinary skilled in the art would recognize many variations, alternatives, and modifications. In some embodiments and as shown, the shunting catheter1700includes a catheter shaft1702and an ablation assembly1704.

In some embodiments, the ablation assembly1704is disposed within the catheter shaft1702at a first state (for example, during deployment, during deployment to position the ablation assembly1704). In some embodiments, the ablation assembly1704is extended from the catheter shaft1702at a second state (for example, during shunting).

According to certain embodiments, the shunting catheter1700includes an apposition element1706configured to be disposed within the catheter shaft1702at a first state (for example, during deployment), and protrudes from the catheter shaft1702at a second state (for example, during shunting). According to some embodiments, for example during the tracking of the shunting catheter1700to a target location in a patient's CS, the ablation assembly1704may be translated out of the catheter shaft1702to puncture a target location on a wall1708(for example, a vessel wall between a patient's CS and LA). In embodiments, the apposition element1706is made of a flexible material and configured to appose a vessel wall1708(for example, a vessel wall between a patient's CS and LA) during shunting. In some embodiments, the apposition element1706provides stability to the shunting catheter1700during deployment and/or shunting.

In some embodiments, the ablation assembly1704includes a crimping shaft1710having a predetermined curve, a puncture element1712, and an ablation mechanism1714. In some embodiments, the ablation assembly1704may have a telescoping feature (for example, the puncture element1712and the ablation mechanism1714are retractable into the crimping shaft1710) to allow for the blunt end of the crimping shaft1710to contact the wall1708before the puncture element1712is translated forward to make contact with the wall1708. In certain embodiments, the telescoping feature of the ablation assembly1704allows for a safe delivery of the puncture element1712to the target location.

In some embodiments, for example as shown inFIG.17A, the ablation assembly1704has a first deployment state where the crimping shaft1710and the ablation assembly1704are extended from the catheter shaft1702, and the puncture element1712and the ablation mechanism1714are retracted and crimped inside the crimping shaft1710. In certain embodiments and as shown, the distal end of the crimping shaft1710provides a blunt surface during the first deployment state, such that if adjustment of position is needed, the wall surrounding the target location would only make contact with a blunt surface.

In some embodiments, the ablation assembly1704has a second deployment state where the ablation mechanism1714and the puncture element1712are partially extended from the crimping shaft1710. In certain embodiments, at the second deployment state a plurality of positioning elements1716of the ablation mechanism1714and the puncture element1712are extended from the crimping shaft1710, and a plurality of expandable struts1718of the ablation mechanism1714are retracted in the lumen of the crimping shaft1710. In certain embodiments, the puncture element1712punctures an opening in the wall1708in the patient upon moving from the first deployment state to the second deployment state. In some embodiments, the ablation assembly1704has a third deployment state where the ablation mechanism1714and the puncture element1712are further extended from the crimping shaft1710. In some embodiments, at the third deployment state the plurality of positioning elements1716and the plurality of expandable struts1718of the ablation mechanism1714and the puncture element1712are extended from the crimping shaft1710. In certain embodiments, the ablation assembly1704is expanded in the third deployment state and thereby enlarges the opening in the wall1708in the patient. In certain embodiments, the ablation assembly1704ablates tissue at the opening in the wall1708in the patient by delivering ablation energy (such as radiofrequency (RF) energy, phased RF energy, cryogenic energy, thermal energy, pulse energy, laser energy, microwave energy, ultrasound energy, and/or the like) to the tissue.

FIGS.18A-18Dare schematic diagrams of side views of an example of a shunting catheter1800, according to certain embodiments of the present disclosure.FIGS.18A-18Dare merely examples. One of the ordinary skilled in the art would recognize many variations, alternatives, and modifications. In certain embodiments and as shown, the shunting catheter1800includes a catheter shaft1802and an ablation assembly1804.

In some embodiments, the ablation assembly1804is disposed within the catheter shaft1802at a first state (for example, during deployment, during deployment to position the ablation assembly1804). In some embodiments, the ablation assembly1804is extended from the catheter shaft1802at a second state (for example, during shunting). In certain embodiments, the ablation assembly1804is extended from an end of the catheter shaft1802at the second state.

According to certain embodiments and as shown inFIG.18A, a guidewire1806is advanced through the vasculature (for example, the IVC and the RA) and punctures an opening in the tissue at a target location in a patient (for example, the patient's AS). According to some embodiments and as shown inFIG.18B, for example after using the guidewire1806to advance the shunting catheter1800to the target location in a patient's AS, the ablation assembly1804has a first deployment state in which the ablation assembly1804is translated out of the catheter shaft1802and enters the opening formed at the target location. In certain embodiments and as shown inFIG.18C, the ablation assembly1804has a second deployment state in which the ablation assembly1804is partially expanded, more specifically a plurality of positioning elements1808of the ablation assembly1804are extended from a crimping shaft1810, and a plurality of expandable struts1812(FIG.18D) of the ablation assembly1804are retracted in the crimping shaft1810. In some embodiments and as shown inFIG.18D, the ablation assembly1804has a third deployment state in which the ablation assembly1804is further expanded, more specifically the plurality of expandable struts1812of the ablation assembly1804are extended from the crimping shaft1810. In some embodiments, in the third deployment state the expandable struts1812are expanded and thereby enlarge the opening in the target location of the patient. In certain embodiments, the ablation assembly1804ablates tissue at the opening in the target location of the patient by delivering ablation energy (such as radiofrequency (RF) energy, phased RF energy, cryogenic energy, thermal energy, pulse energy, laser energy, microwave energy, ultrasound energy, and/or the like) to the tissue.

FIG.19is a flow diagram illustrating an example method1900of creating a shunt in a patient, in accordance with embodiments of the present disclosure. Aspects of embodiments of the method may be performed, for example, by a shunting catheter system or a controller (for example, the system104inFIG.1, the controller112inFIG.1). One or more steps of method are optional and/or can be modified by one or more steps of other embodiments described herein. Additionally, one or more steps of other embodiments described herein may be added to the method. In some embodiments, the shunt may be formed in a coronary sinus of a patient. In certain embodiments, the shunt includes an opening between a patient's coronary sinus and left atrium.

At step1902, the method1900includes deploying a shunting catheter in a first state, the shunting catheter including a catheter shaft including a shaft lumen and an ablation shaft disposed in the shaft lumen at the first state. In some embodiments, an ablation mechanism is disposed on the ablation shaft, and the ablation mechanism includes a plurality of expandable struts and a plurality of positioning elements. In some embodiments, the ablation mechanism is configured to receive energy (for example, electrical energy) from an energy source. In certain embodiments, deploying the shunting catheter includes inserting the shunting catheter through a superior vena cava of a patient into a coronary sinus of the patient. In certain embodiments, deploying the shunting catheter includes inserting the shunting catheter through an inferior vena cava of a patient into a coronary sinus of the patient.

At step1904, the method1900includes disposing the shunting catheter proximate to a target location of a patient. At step1906, the method1900includes operating the shunting catheter to a second state (more specifically, for example, a first deployment state), wherein the ablation shaft is extended from the catheter shaft. In certain embodiments, the ablation mechanism is disposed in the ablation shaft at the first deployment state. In some embodiments, the ablation shaft is extended from a side opening of the catheter shaft. In certain embodiments, the ablation shaft is extended from an end of the catheter shaft. In some embodiments, operating the shunting catheter to the second state further includes retracting a crimping shaft from a puncture element of the shunting catheter. In certain embodiments, in the second state a plurality of positioning elements and a plurality of expandable struts of the ablation mechanism are retracted in the crimping shaft. In some embodiments, the shunting catheter includes an apposition element disposed proximate to the ablation mechanism, and the apposition element is protruded from the catheter shaft at the second state.

At step1908, the method1900includes puncturing, using the puncture element of the shunting catheter, an opening at the target location. In some embodiments, the target location is at a coronary sinus of a patient. In some embodiments, the puncture element physically contacts tissue to puncture an opening at the target location in the patient. Additionally or alternatively, the puncture element receives energy (for example, electrical energy) and delivers ablation energy (such as radiofrequency (RF) energy, phased RF energy, cryogenic energy, thermal energy, pulse energy, laser energy, ultrasound energy, microwave energy, and/or the like) to tissue to puncture an opening at the target location in the patient. In some instances, the method1900may include stabilizing the ablation mechanism in the second state, and before puncturing the opening at the target location.

At step1910, the method1900includes anchoring the ablation mechanism at the target location in the second state (more specifically, for example, in a second deployment state). In certain embodiments, such anchoring includes contacting the positioning elements of the ablation mechanism, which are extended from the crimping shaft in the second deployment state, against tissue at the target location of the patient. In certain embodiments, such anchoring includes contacting curved distal ends of the positioning elements, which define soft landing zones, against tissue at the target location of the patient. In some embodiments, contacting the positioning elements against tissue at the target location of the patient includes permitting the positioning elements to self-expand in the second deployment state. In some embodiments, in the second deployment state the expandable struts are retracted in the crimping shaft.

At step1912, the method1900includes expanding the opening in the tissue using the ablation mechanism in the second state (more specifically, for example, in a third deployment state). In certain embodiments, the expandable struts are extended from the crimping shaft in the third deployment state. In some embodiments, expanding the opening includes permitting the expandable struts to self-expand in the third deployment state. In some embodiments, expanding the opening includes expanding the expandable struts by operating an actuator, for example inflating a balloon carried within the ablation mechanism.

At step1914, the method1900includes delivering ablation energy (such as radiofrequency (RF) energy, phased RF energy, cryogenic energy, thermal energy, pulse energy, laser energy, ultrasound energy, microwave energy, and/or the like) via the ablation mechanism to tissue at the target location. In some embodiments, the ablation mechanism delivers the ablation energy while expanded in the second state, more specifically the third deployment state. In some embodiments, delivering the ablation energy to the tissue at the target location solidifies the opening at the target location.

At step1916, the method1900includes retracting the puncture element and the ablation mechanism from the tissue at the target location in the patient. In certain embodiments, retracting the puncture element and the ablation mechanism includes moving the puncture element and the ablation mechanism into the crimping shaft. In certain embodiments, retracting the puncture element and the ablation mechanism includes compressing the ablation mechanism in the crimping shaft.

At step1918, the method1900includes removing the shunting catheter from the patient. In some embodiments, the method1900may include removing the shunting catheter, which includes removing the catheter shaft, the puncture element, and the ablation mechanism. In certain embodiments, the method1900does not leave any implant device at the target location. In some embodiments, the formed shunt is an opening between a coronary sinus and a left atrium of a patient. In certain embodiments, the shunting catheter is removed from the coronary sinus of the patient. In certain embodiments, the formed shunt is an opening that does not include an implant (for example, a frame or structure to support an opening). In some embodiments, the shunt includes an opening between the coronary sinus and the left atrium of a patient, where the shunt does not include an implant.

According to some embodiments, the method1900includes generating a shunt using a puncture element and an ablation mechanism of a shunting catheter. In certain embodiments, the shunt includes an expanded opening between the coronary sinus and left atrium of a patient. In some embodiments, the shunt does not include any implant.

FIG.20is a flow diagram illustrating an example method2000of creating a shunt in a patient, in accordance with embodiments of the present disclosure. Aspects of embodiments of the method may be performed, for example, by a shunting catheter system or a controller (for example, the system104inFIG.1, the controller112in FIG.1). One or more steps of method are optional and/or can be modified by one or more steps of other embodiments described herein. Additionally, one or more steps of other embodiments described herein may be added to the method.

At step2002, the method2000includes deploying a shunting catheter in a first state into a coronary sinus of a patient, the shunting catheter including a catheter shaft including a shaft lumen and an ablation shaft disposed in the shaft lumen at the first state. In some embodiments, an ablation mechanism is disposed on the ablation shaft, and the ablation mechanism includes a plurality of expandable struts and a plurality of positioning elements. In some embodiments, the ablation mechanism is configured to receive energy (for example, electrical energy) from an energy source. In certain embodiments, deploying the shunting catheter includes inserting the shunting catheter through a superior vena cava of a patient into the coronary sinus of the patient. In certain embodiments, deploying the shunting catheter includes inserting the shunting catheter through an inferior vena cava of a patient into the coronary sinus of the patient.

At step2004, the method2000includes disposing the shunting catheter proximate to a target coronary sinus location of a patient. At step2006, the method2000includes stabilizing the ablation mechanism in the coronary sinus by using an apposition element of the shunting catheter.

At step2008, the method2000includes operating the shunting catheter to a second state (more specifically, for example, a first deployment state), wherein the ablation shaft is extended from the catheter shaft. In certain embodiments, the ablation mechanism is disposed in the ablation shaft at the first deployment state. In some embodiments, the ablation shaft is extended from a side opening of the catheter shaft. In certain embodiments, the ablation shaft is extended from an end of the catheter shaft. In some embodiments, operating the shunting catheter to the second state further includes retracting a crimping shaft from a puncture element of the shunting catheter. In certain embodiments, in the second state a plurality of positioning elements and a plurality of expandable struts of the ablation mechanism are retracted in the crimping shaft.

At step2010, the method2000includes puncturing, using the puncture element of the shunting catheter, an opening at the target coronary sinus location. In some embodiments, the puncture element physically contacts coronary sinus tissue to puncture an opening at the target coronary sinus location in the patient. Additionally or alternatively, the puncture element receives energy (for example, electrical energy) and delivers ablation energy (such as radiofrequency (RF) energy, phased RF energy, cryogenic energy, thermal energy, pulse energy, laser energy, ultrasound energy, microwave energy, and/or the like) to tissue to puncture an opening at the target coronary sinus location in the patient.

At step2012, the method2000includes anchoring the ablation mechanism at the target coronary sinus location in the second state (more specifically, for example, in a second deployment state). In certain embodiments, such anchoring includes contacting the positioning elements of the ablation mechanism, which are extended from the crimping shaft in the second deployment state, against tissue at the target coronary sinus location of the patient. In certain embodiments, such anchoring includes contacting curved distal ends of the positioning elements, which define soft landing zones, against tissue at the target coronary sinus location of the patient. In some embodiments, contacting the positioning elements against tissue at the target coronary sinus location of the patient includes permitting the positioning elements to self-expand in the second deployment state. In some embodiments, in the second deployment state the expandable struts are retracted in the crimping shaft.

At step2014, the method2000includes expanding the opening in the tissue using the ablation mechanism in the second state (more specifically, for example, in a third deployment state). In certain embodiments, the expandable struts are extended from the crimping shaft in the third deployment state. In some embodiments, expanding the opening includes permitting the expandable struts to self-expand in the third deployment state. In some embodiments, expanding the opening includes expanding the expandable struts by operating an actuator, for example inflating a balloon carried within the ablation mechanism.

At step2016, the method2000includes delivering ablation energy (such as radiofrequency (RF) energy, phased RF energy, cryogenic energy, thermal energy, pulse energy, laser energy, ultrasound energy, microwave energy, and/or the like) via the ablation mechanism to tissue at the target coronary sinus location. In some embodiments, the ablation mechanism delivers the ablation energy while expanded in the second state, more specifically the third deployment state. In some embodiments, delivering the ablation energy to the tissue at the target coronary sinus location solidifies the opening at the target coronary sinus location.

At step2018, the method2000includes retracting the puncture element and the ablation mechanism from the tissue at the target coronary sinus location in the patient. In certain embodiments, retracting the puncture element and the ablation mechanism includes moving the puncture element and the ablation mechanism into the crimping shaft. In certain embodiments, retracting the puncture element and the ablation mechanism includes compressing the ablation mechanism in the crimping shaft.

At step2020, the method2000includes removing the shunting catheter from the patient. In some embodiments, the method2000may include removing the shunting catheter, which includes removing the catheter shaft, the puncture element, and the ablation mechanism. In certain embodiments, the method2000does not leave any implant device at the target coronary sinus location. In some embodiments, the formed shunt is an opening between the coronary sinus and the left atrium of a patient. In certain embodiments, the shunting catheter is removed from the coronary sinus of the patient. In certain embodiments, the formed shunt is an opening that does not include an implant (for example, a frame or structure to support an opening). In some embodiments, the shunt includes an opening between the coronary sinus and the left atrium of a patient, where the shunt does not include an implant.

According to some embodiments, the method2000includes generating a shunt using a puncture element and an ablation mechanism of a shunting catheter. In certain embodiments, the shunt includes an expanded opening between the coronary sinus and left atrium of a patient. In some embodiments, the shunt does not include any implant.

FIG.21is a flow diagram illustrating an example method2100of creating a shunt in a patient, in accordance with embodiments of the present disclosure. Aspects of embodiments of the method may be performed, for example, by a shunting catheter system or a controller (for example, the system104inFIG.1, the controller112inFIG.1). One or more steps of method are optional and/or can be modified by one or more steps of other embodiments described herein. Additionally, one or more steps of other embodiments described herein may be added to the method.

At step2102, the method2100includes puncturing, using a guidewire, an opening at a target atrial septum location in a patient. In some embodiments, the guidewire is inserted through an inferior vena cava of the patient into the RA of the patient to puncture the opening at the target atrial septum location. In some embodiments, the guidewire is inserted through a superior vena cava of the patient into the RA of the patient to puncture the opening at the target atrial septum location.

At step2104, the method2100includes deploying a shunting catheter in a first state into a right atrium (RA) of a patient, the shunting catheter including a catheter shaft including a shaft lumen and an ablation shaft disposed in the shaft lumen at the first state. In certain embodiments, an ablation mechanism is disposed on the ablation shaft, and the ablation mechanism includes a plurality of positioning elements and a plurality of expandable struts. In some embodiments, the ablation mechanism is configured to receive energy from an energy source. In certain embodiments, the shunting catheter tracks along the guidewire to deploy into the RA of the patient. In certain embodiments, deploying the shunting catheter includes inserting the shunting catheter through the inferior vena cava of the patient into the RA of the patient. In certain embodiments, deploying the shunting catheter includes inserting the shunting catheter through the superior vena cava of the patient into the RA of the patient.

At step2106, the method2100includes disposing the shunting catheter proximate to the target atrial septum location of the patient. In some embodiments, the shunting catheter is disposed proximate to the target atrial septum location by advancing the shunting catheter along the guidewire.

At step2108, the method2100includes operating the shunting catheter to a second state (more specifically, for example, a first deployment state), wherein the ablation shaft is extended from the catheter shaft. In certain embodiments, the ablation mechanism is disposed in the ablation shaft at the first deployment state. In some embodiments, the ablation shaft is extended from a side opening of the catheter shaft. In certain embodiments, the ablation shaft is extended from an end of the catheter shaft. In some embodiments, operating the shunting catheter to the second state further includes retracting a crimping shaft from a puncture element of the shunting catheter. In certain embodiments, in the first deployment state a plurality of positioning elements and a plurality of expandable struts of the ablation mechanism are retracted in the crimping shaft.

At step2110, the method2100includes puncturing, using the puncture element of the shunting catheter, an opening at the target atrial septum location. In some embodiments, the puncture element physically contacts atrial septum tissue to puncture an opening at the target atrial septum location in the patient. Additionally or alternatively, the puncture element receives energy (for example, electrical energy) and delivers ablation energy (such as radiofrequency (RF) energy, phased RF energy, cryogenic energy, thermal energy, pulse energy, laser energy, ultrasound energy, microwave energy, and/or the like) to tissue to puncture an opening at the target atrial septum location in the patient.

At step2112, the method2100includes anchoring the ablation mechanism at the target atrial septum location in the second state (more specifically, for example, in a second deployment state). In certain embodiments, such anchoring includes contacting the positioning elements of the ablation mechanism, which are extended from the crimping shaft in the second deployment state, against tissue at the target atrial septum location of the patient. In certain embodiments, such anchoring includes contacting curved distal ends of the positioning elements, which define soft landing zones, against tissue at the target atrial septum location of the patient. In some embodiments, contacting the positioning elements against tissue at the target atrial septum location of the patient includes permitting the positioning elements to self-expand in the second deployment state. In some embodiments, in the second deployment state the expandable struts are retracted in the crimping shaft.

At step2114, the method2100includes expanding the opening in the tissue using the ablation mechanism in the second state (more specifically, for example, in a third deployment state). In certain embodiments, the expandable struts are extended from the crimping shaft in the third deployment state. In some embodiments, expanding the opening includes permitting the expandable struts to self-expand in the third deployment state. In some embodiments, expanding the opening includes expanding the expandable struts by operating an actuator, for example inflating a balloon carried within the ablation mechanism.

At step2116, the method2100includes delivering ablation energy (such as radiofrequency (RF) energy, phased RF energy, cryogenic energy, thermal energy, pulse energy, laser energy, ultrasound energy, microwave energy, and/or the like) via the ablation mechanism to tissue at the target atrial septum location. In some embodiments, the ablation mechanism delivers the ablation energy while expanded in the second state, more specifically the third deployment state. In some embodiments, delivering the ablation energy to the tissue at the target atrial septum location solidifies the opening at the target atrial septum location.

At step2118, the method2100includes retracting the puncture element and the ablation mechanism from the tissue at the target atrial septum location in the patient. In certain embodiments, retracting the puncture element and the ablation mechanism includes moving the puncture element and the ablation mechanism into the crimping shaft. In certain embodiments, retracting the puncture element and the ablation mechanism includes compressing the ablation mechanism in the crimping shaft.

At step2120, the method2100includes removing the shunting catheter from the patient. In some embodiments, the method2100may include removing the shunting catheter, which includes removing the catheter shaft, the puncture element, and the ablation mechanism. In certain embodiments, the method2100does not leave any implant device at the target atrial septum location. In some embodiments, the formed shunt is an opening in the atrial septum of the patient. In certain embodiments, the shunting catheter is removed from the RA of the patient. In certain embodiments, the formed shunt is an opening that does not include an implant (for example, a frame or structure to support an opening). In some embodiments, the shunt includes an opening in the atrial septum of a patient, where the shunt does not include an implant.

According to some embodiments, the method2100includes generating a shunt using a puncture element and an ablation mechanism of a shunting catheter. In certain embodiments, the shunt includes an expanded opening in the atrial septum of a patient. In some embodiments, the shunt does not include any implant. In certain embodiments, the method2100does not include using a shunting catheter; more specifically, the ablation catheter may be advanced directly over the guidewire to the target atrial septum location.

According to some embodiments, a shunting catheter includes: a catheter shaft including a shaft lumen; an ablation shaft disposed in the shaft lumen at a first state and extended from the catheter shaft at a second state; and an ablation mechanism disposed on the ablation shaft and expandable at the second state, the ablation mechanism including: a plurality of expandable struts; and a plurality of positioning elements coupled to the plurality of expandable struts and disposed radially outwardly from the plurality of expandable struts at the second state; wherein the ablation mechanism is configured to receive energy from an energy source and deliver ablation energy to a target location of a patient.

According to some embodiments, further including a crimping shaft including a lumen, wherein the second state of the shunting catheter includes a first deployment state, a second deployment state, and a third deployment state, in the first deployment state the plurality of positioning elements and the plurality of expandable struts are retracted in the lumen of the crimping shaft, in the second deployment state the plurality of positioning elements extend outwardly from the lumen of the crimping shaft and the plurality of expandable struts are retracted in the lumen of the crimping shaft, and in the third deployment state the plurality of positioning elements and the plurality of expandable struts extend outwardly from the lumen of the crimping shaft.

According to certain embodiments, a portion of the ablation mechanism includes an insulator configured to inhibit transmission of the ablation energy therethrough.

According to some embodiments, the insulator covers at least one of the plurality of expandable struts.

According to certain embodiments, the insulator covers at least one of the plurality of positioning elements.

According to some embodiments, the insulator includes a heat shrink tube, a polytetrafluoroethylene (PTFE) tube, an expanded polytetrafluoroethylene (ePTFE) tube, or a polyimide tube.

According to certain embodiments, at least one of the positioning elements of the plurality of positioning elements includes a curved distal end defining a soft landing zone configured to contact tissue at the target location of the patient.

According to certain embodiments, the plurality of positioning elements includes a first positioning element and a second positioning element, the second positioning element being longitudinally offset from the first positioning element.

According to some embodiments, the ablation mechanism further includes a plurality of connector struts, each connector strut of the plurality of connector struts disposed between and coupling adjacent expandable struts of the plurality of expandable struts.

According to certain embodiments, the ablation mechanism further includes a plurality of iris elements disposed radially outwardly from the plurality of expandable struts, the plurality of iris elements together defining an expandable iris assembly.

According to some embodiments, the ablation mechanism further includes at least one electrode disposed on the expandable iris assembly and configured to deliver the ablation energy to the target location of the patient.

According to certain embodiments, the plurality of expandable struts are configured to act as electrodes and deliver the ablation energy to the target location of the patient.

According to some embodiments, the ablation mechanism further includes at least one electrode disposed on at least one of the plurality of expandable struts and configured to deliver the ablation energy to the target location of the patient.

According to certain embodiments, the plurality of expandable struts are self-expandable at the second state.

According to some embodiments, further including an actuator being actuatable to expand the ablation mechanism.

According to certain embodiments, the actuator includes an inflatable balloon.

According to some embodiments, further including a temperature sensor coupled to the ablation mechanism.

According to certain embodiments, the plurality of expandable struts includes at least one selected from a group consisting of nitinol, stainless steel, titanium, platinum-iridium, and cobalt-chromium.

According to some embodiments, the catheter shaft defines a first axis, the ablation shaft defines a second axis at the second state, and the second axis and the first axis form an angle greater than zero degrees.

According to certain embodiments, the plurality of positioning elements include a flexible material.

According to some embodiments, the plurality of positioning elements are integrally formed with the plurality of expandable struts.

According to certain embodiments, the plurality of positioning elements includes at least one radiopaque marker.

According to some embodiments, a shunting catheter system includes: a shunting catheter, including: a catheter shaft including a shaft lumen; an ablation shaft disposed in the shaft lumen at a first state and extended from the catheter shaft at a second state; and an ablation mechanism disposed on the ablation shaft, the ablation mechanism including: a plurality of expandable struts defining an expandable cage; a plurality of positioning elements coupled to the plurality of expandable struts and disposed outwardly from the expandable cage at the second state; an energy source connected to the shunting catheter; and a controller connected to the energy source and including a processor; wherein the processor is configured to control the energy source to deliver ablation energy to a target location of a patient via the ablation mechanism.

According to certain embodiments, further including a crimping shaft including a lumen, wherein the second state of the shunting catheter includes a first deployment state, a second deployment state, and a third deployment state, in the first deployment state the plurality of positioning elements and the plurality of expandable struts are retracted in the lumen of the crimping shaft, in the second deployment state the plurality of positioning elements extend outwardly from the lumen of the crimping shaft and the plurality of expandable struts are retracted in the lumen of the crimping shaft, and in the third deployment state the plurality of positioning elements and the plurality of expandable struts extend outwardly from the lumen of the crimping shaft.

According to some embodiments, a portion of the ablation mechanism includes an insulator configured to inhibit transmission of the ablation energy therethrough.

According to certain embodiments, the insulator covers at least one of the plurality of expandable struts.

According to some embodiments, the insulator covers at least one of the plurality of positioning elements.

According to certain embodiments, the insulator includes a heat shrink tube, a polytetrafluoroethylene (PTFE) tube, an expanded polytetrafluoroethylene (ePTFE) tube, or a polyimide tube.

According to some embodiments, at least one of the positioning elements of the plurality of positioning elements includes a curved distal end defining a soft landing zone configured to contact tissue at the target location of the patient.

According to certain embodiments, the plurality of positioning elements includes a first positioning element and a second positioning element, the second positioning element being longitudinally offset from the first positioning element.

According to some embodiments, the ablation mechanism further includes a plurality of connector struts, each connector strut of the plurality of connector struts disposed between and coupling adjacent expandable struts of the plurality of expandable struts.

According to certain embodiments, the ablation mechanism further includes a plurality of iris elements disposed radially outwardly from the plurality of expandable struts, the plurality of iris elements together defining an expandable iris assembly.

According to some embodiments, the ablation mechanism further includes at least one electrode disposed on the expandable iris assembly and configured to deliver the ablation energy to the target location of the patient.

According to certain embodiments, the plurality of expandable struts act as electrodes and are configured to deliver the ablation energy to the target location of the patient.

According to some embodiments, the ablation mechanism further includes at least one electrode connected to the expandable cage and configured to deliver the ablation energy to the target location of the patient.

According to certain embodiments, the ablation energy includes at least one of radiofrequency (RF) energy, phased RF energy, cryogenic energy, thermal energy, pulse energy, laser energy, ultrasound energy, microwave energy.

According to certain embodiments, the plurality of expandable struts are self-expandable at the second state.

According to some embodiments, the shunting catheter further includes an actuator being actuatable to expand the expandable cage.

According to certain embodiments, the actuator includes an inflatable balloon.

According to some embodiments, the plurality of positioning elements include a flexible material.

According to certain embodiments, the plurality of positioning elements are integrally formed with the expandable cage.

According to some embodiments, a method for creating a shunt includes: deploying a shunting catheter in a first state, the shunting catheter including: a catheter shaft including a shaft lumen; an ablation shaft disposed in the shaft lumen at a first state; and an ablation mechanism disposed on the ablation shaft and including a plurality of expandable struts and a plurality of positioning elements; disposing the shunting catheter proximate to a target location of a patient; operating the shunting catheter to a second state, wherein the ablation shaft and the ablation mechanism extend from the catheter shaft; contacting at least one of the plurality of positioning elements against tissue at the target location of the patient; expanding an opening at the target location of the patient by expanding the plurality of expandable struts; and delivering ablation energy via the ablation mechanism to the target location of the patient.

According to certain embodiments, the shunting catheter further includes a crimping shaft including a lumen, and operating the shunting catheter to the second state includes operating the shunting catheter to a first deployment state, then a second deployment state, and then a third deployment state, in the first deployment state the plurality of positioning elements and the plurality of expandable struts are retracted in the lumen of the crimping shaft, in the second deployment state the plurality of positioning elements extend outwardly from the lumen of the crimping shaft and the plurality of expandable struts are retracted in the lumen of the crimping shaft, and in the third deployment state the plurality of positioning elements and the plurality of expandable struts extend outwardly from the lumen of the crimping shaft.

According to some embodiments, the at least one of the positioning elements includes a curved distal end defining a soft landing zone, and contacting the at least one of the positioning elements against the tissue at the target location of the patient includes contacting the soft landing zone against the tissue at the target location of the patient.

According to certain embodiments, contacting the at least one of the positioning elements against tissue at the target location of the patient includes permitting the at least one of the plurality of positioning elements to self-expand.

According to some embodiments, permitting the at least one of the positioning elements to self-expand includes retracting a crimping shaft from the at least one of the plurality of positioning elements.

According to certain embodiments, expanding the plurality of expandable struts includes permitting the plurality of expandable struts to self-expand.

According to some embodiments, permitting the plurality of expandable struts to self-expand includes retracting a crimping shaft from the plurality of expandable struts.

According to certain embodiments, contacting the at least one of the positioning elements against tissue at the target location of the patient precedes expanding the opening at the target location of the patient by expanding the plurality of expandable struts.

According to some embodiments, a portion of the ablation mechanism includes an insulator configured to inhibit transmission of the ablation energy therethrough.

According to certain embodiments, the insulator covers at least one of the plurality of expandable struts.

According to some embodiments, the insulator covers at least one of the plurality of positioning elements.

According to certain embodiments, the insulator includes a heat shrink tube, a polytetrafluoroethylene (PTFE) tube, an expanded polytetrafluoroethylene (ePTFE) tube, or a polyimide tube.

According to some embodiments, the plurality of positioning elements includes a first positioning element and a second positioning element, the second positioning element being longitudinally offset from the first positioning element.

According to certain embodiments, the ablation mechanism further includes a plurality of connector struts, each connector strut of the plurality of connector struts disposed between and coupling adjacent expandable struts of the plurality of expandable struts.

According to some embodiments, the ablation mechanism further includes a plurality of iris elements disposed radially outwardly from the plurality of expandable struts, the plurality of iris elements together defining an expandable iris assembly, and expanding the opening at the target location of the patient further includes expanding the expandable iris assembly.

According to certain embodiments, the ablation mechanism further includes at least one electrode disposed on the expandable iris assembly, and delivering ablation energy via the ablation mechanism to the target location includes delivering ablation energy via the at least one electrode.

According to some embodiments, delivering the ablation energy includes delivering the ablation energy via the plurality of expandable struts to the target location of the patient.

According to certain embodiments, the ablation mechanism further includes at least one electrode connected to the plurality of expandable struts, and wherein delivering the ablation energy includes delivering the ablation energy via the at least one electrode to the target location of the patient.

According to some embodiments, the shunting catheter further includes an actuator, and wherein expanding the plurality of expandable struts includes actuating the actuator to expand the plurality of expandable struts.

According to certain embodiments, expanding the plurality of expandable struts includes inflating a balloon to expand the plurality of expandable struts.

According to some embodiments, the target location is at a coronary sinus of the patient.

According to certain embodiments, the target location is at an atrial septum of the patient.

Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present disclosure. For example, while the embodiments described above refer to particular features, the scope of this 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 as fall within the scope of the claims, together with all equivalents thereof.