WO2024137811A2

WO2024137811A2 - Delivery systems for implantable shunting systems and associated devices and methods

Info

Publication number: WO2024137811A2
Application number: PCT/US2023/085137
Authority: WO
Inventors: Anthony Pantages; Jace Valls; Jonathan Cox; Virgilina Tan PAPASIN; Sambhav JAIN; Greg YEH
Original assignee: Shifamed Holdings LLC
Current assignee: Shifamed Holdings LLC
Priority date: 2022-12-23
Filing date: 2023-12-20
Publication date: 2024-06-27
Anticipated expiration: 2025-06-23
Also published as: WO2024137811A3

Abstract

The present technology generally relates to delivery systems for implantable shunting systems, and associated devices and methods. In some embodiments, an interatrial shunt delivery system can include a catheter and a deflection assembly. The catheter can define a lumen configured to carry an interatrial shunt. The deflection assembly can be configured to bend and thereby cause the catheter to bend. During a procedure, the interatrial shunt delivery system can be advanced into a right atrium of a patient. The deflection assembly can be used to set a curvature of at least a portion of the catheter, for example, by causing the catheter to bend. With the curvature set, the interatrial shunt delivery system can then be advanced toward and/or at least partially through a septal wall of the patient while maintaining the curvature of at least the portion of the catheter.

Description

DELIVERY SYSTEMS FOR IMPLANTABLE SHUNTING SYSTEMS

AND ASSOCIATED DEVICES AND METHODS

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to U.S. Provisional Patent Application No. 63/477,101, filed December 23, 2022, the disclosure of which is incorporated herein by reference in its entirety.

TECHNICAL FIELD

[0002] The present technology generally relates to delivery systems for implantable shunting systems and associated devices and methods.

BACKGROUND

[0003] Shunting systems have been widely proposed for treating various disorders associated with fluid build-up or pressure in a particular body region. For example, interatrial shunting systems that shunt blood from the left atrium of the heart to the right atrium of the heart have been proposed as a treatment for heart failure in general, and heart failure with preserved ejection fraction in particular. Proposed shunting systems range in complexity from simple tube shunts to more sophisticated systems having on-board electronics, adjustable lumens, or the like. Despite the advancement of shunting system technology, designing shunting systems that can be reliably and relatively non-invasively delivered and deployed across a target structure remains a challenge.

BRIEF DESCRIPTION OF THE DRAWINGS

[0004] FIG. 1 is a schematic illustration of an interatrial device implanted in a heart and configured in accordance with select embodiments of the present technology.

[0005] FIG. 2A is a partially schematic side view of an interatrial shunt delivery' sy stem configured in accordance with embodiments of the present technology.

[0006] FIGS. 2B and 2C are a perspective view and a side view, respectively, of a deflection tube of the interatrial shunt delivery system of FIG. 2A configured in accordance with embodiments of the present technology.

[0007] FIG. 2D is a side view of the interatrial shunt delivery system of FIG. 2A. [0008] FIGS. 3A-3E illustrate various stages of an operation to implant an adjustable interatrial shunt using the interatrial shunt delivery system of FIG. 2A, in accordance with embodiments of the present technology.

[0009] FIGS. 4A and 4B are partially schematic side views of another interatrial shunt delivery system configured in accordance with embodiments of the present technology.

[0010] FIGS. 5 A and 5B are partially schematic side views of another interatrial shunt delivery system configured in accordance with embodiments of the present technology.

DETAILED DESCRIPTION

[0011] The present technology is directed to delivery systems for implantable shunting systems and associated devices and methods. In some embodiments, an interatrial shunt delivery system includes a catheter and a deflection assembly. The catheter defines a lumen configured to earn an interatrial shunt. The deflection assembly is configured to bend and thereby cause the catheter to bend. During a procedure, the interatrial shunt delivery' system can be advanced into a right atrium of a patient. The deflection assembly can be used to set a curvature of at least a portion of the catheter by causing the catheter to bend. The catheter can then be advanced over the deflection assembly at least partially through a septal wall of the patient while maintaining the curvature of at least the portion of the catheter. In some embodiments, for example, the catheter can approach the septal wall with at least a portion of the catheter perpendicular to the septal wall, which is expected to reduce distension of the septal wall and/or improve the navigability of the interatrial shunt delivery system in relatively small atria.

[0012] The terminology' used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the present technology'. Certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section. Additionally, the present technology can include other embodiments that are within the scope of the examples but are not described in detail with respect to FIGS. 1-5B.

[0013] Reference throughout this specification to ‘‘one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present technology. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features or characteristics may be combined in any suitable manner in one or more embodiments.

[0014] Reference throughout this specification to relative terms such as, for example, “generally,’’ “approximately,” and “about” are used herein to mean the stated value plus or minus 10%.

[0015] As used herein, the terms “interatrial device,” “interatrial shunt device,” “IAD,” “IASD,” “interatrial shunt,” and “shunt” are used interchangeably to refer to a device that, in at least one configuration, includes a shunting element that provides a blood flow between a first region (e.g., a left atrium of a heart) and a second region (e.g., a right atrium or coronary sinus of the heart) of a patient. Although described in terms of a shunt between the atria, namely the left and right atria, one will appreciate that the technology' may be applied equally to devices positioned between other chambers and passages of the heart, or between other parts of the cardiovascular system. For example, any of the shunts described herein, including those referred to as “interatrial,” may be nevertheless used and/or modified to shunt blood between the left atrium (“LA”) and the coronary sinus, or between the right pulmonary vein and the superior vena cava. Moreover, while the disclosure herein primarily describes shunting blood from the LA to the right atrium (“RA”), the present technology can be readily adapted to shunt blood from the RA to the LA to treat certain conditions, such as pulmonary hypertension. For example, mirror images of embodiments, or in some cases identical embodiments, used to shunt blood from the LA to the RA can be used to shunt blood from the RA to the LA in certain patients. Moreover, while certain embodiments herein are described in the context of heart failure treatment, any of the embodiments herein, including those referred to as interatrial shunts, may nevertheless be used and/or modified to treat other diseases or conditions, including other diseases or conditions of other body regions. For example, the systems described herein can be used to treat diseases characterized by increased pressure and/or fluid build-up, including but not limited to glaucoma, pulmonary failure, renal failure, hydrocephalus, and the like.

[0016] Interatrial shunts have recently been proposed as a way to reduce elevated left atrial pressure, and this emerging class of cardiovascular therapeutic interventions has been demonstrated to have significant clinical promise in treating patients with heart failure. FIG. 1, for example, shows the placement of a shunt 100 in the septal wall S between the LA and RA. Most interatrial shunts (e.g., shunt 100) involve creating a hole or inserting a structure with a lumen into the atrial septal wall, thereby creating a fluid communication pathway between the LA and the RA. As such, elevated left atrial pressure may be partially relieved by unloading the LA into the RA. In early clinical trials, this approach has been shown to improve symptoms of heart failure. The shunt 100, or another interatrial shunt, can be placed in the septal wall using a shunt delivery system, such as the shunt delivery system described below with reference to FIGS. 2A-3E.

[0017] FIG. 2A is a partially schematic side view of an interatrial shunt delivery system 200 (“system 200”) configured in accordance with embodiments of the present technology. The system 200 can include a catheter 202 defining a lumen 204 and a steering or deflection assembly 206. The catheter 202 can comprise one or more polymers, such as polyether block amide copolymer sold under the trademark PEBAX®, nylon, polyurethane, polyimide, a polymer- metal hybrid construction (e.g., a polymer laminated onto a metal or aromatic fiber braid, standard coil, and/or counter wound cable), and/or one or more other suitable materials. The deflection assembly 206 can be positioned within the lumen 204, such as shown in the illustrated embodiment, or in other embodiments the deflection assembly 206 can be positioned outside of the lumen 204, such as coupled to an exterior surface of the catheter 202. The deflection assembly 206 can include a driven component or deflection tube 210 and a drive component or pull-wire 212 operably coupled to the deflection tube 210, e.g., at a distal end portion 214 of the deflection tube 210. The deflection tube 210 can comprise one or more metals (e.g., stainless steel, nickel-cobalt base alloy sold under the trademark MP35N®, titanium, superelastic Nitinol), one or more polymers (e.g.. PEBAX®, nylon, polyurethane, polyimide), a combination thereof (such as a polymer laminated onto a metal or aromatic fiber braid, standard coil, and/or counter wound cable), and/or one or more other suitable materials. In some embodiments, the deflection tube 210 can be or include a hypotube, e.g., including one or more of the above- mentioned materials.

[0018] The pull-wire 212 can be withdrawn proximally relative to the deflection tube 210 to cause the deflection tube 210 to bend or deflect. The bending/deflection of the deflection tube 210 can cause a corresponding bending/deflection of the catheter 202 and thereby transition the catheter 202 from a first or at least generally linear configuration or state 201 (shown partially in dashed line) toward and/or to a second or at least partially curved configuration or state 203. Transitioning the catheter 202 between the first state 201 and the second state 203 can include bending, deflecting, reorienting, rotating, and/or otherwise moving at least one portion of the catheter 202 relative to one or more other portions of the catheter 202. In the illustrated embodiment, for example, the catheter 202 includes a first or distal portion 208a. a second or flexion portion 208b, and a third or proximal portion 208c. The flexion portion 208b can extend between the distal portion 208a and the proximal portion 208c. With continued reference to the illustrated embodiment, the deflection assembly 206 is operably coupled to the catheter 202 to cause the flexion portion 208b to bend or deflect, thereby causing the distal portion 208a to pivot relative to the proximal portion 208c (e.g., about a center of curvature of the flexion portion 208b) and transition the catheter 202 from the first state 201 toward and/or to the second state 203. Additionally, or alternatively, the deflection assembly 206 can be operably coupled to cause an at least generally similar or identical bending/defl ection in one or more other portions of the catheter 202. In these and other embodiments, at least a portion of the catheter 202 can be bent or deflected from a given position or orientation by an angle A of between about 1 degree and about 90 degrees, such as at least 1 degree, 5 degrees, 15 degrees, 30 degrees, 45 degrees, 60 degrees, 75 degrees, any angle therebetween, or another suitable angle. It will be appreciated that the portions 208a-c of the catheter 202 illustrated in FIG. 2A are representative and, in at least some embodiments, one or more of the portions 208a-c can encompass a greater or lesser length of the catheter 202 than depicted in the illustrated embodiment.

[0019] In some embodiments, the catheter 202 includes a deflection assembly housing or sheath 216 configured to receive all or at least a portion of the deflection assembly 206. The sheath 216 can have a length less than, equal to, or greater than a length of the catheter 202. In the illustrated embodiment, for example, the sheath 216 is positioned within the lumen 204 of the catheter 202. In other embodiments, the sheath 216 can be coupled to an exterior surface of the catheter 202. In these and other embodiments, the sheath 216 can be configured to slidably receive all or a portion of the deflection assembly 206, such that the deflection assembly 206 can be moved proximally and/or distally relative to the catheter 202 while positioned within the sheath 216. In at least some embodiments, for example, the deflection assembly 206 can be positioned within the sheath 216 after at least a portion of the catheter 202 has been positioned within a patient. In these and/or other embodiments, the catheter 202 can be configured to move proximally and/or distally over the deflection assembly 206, for example, using the deflection assembly 206 as an internal guidewire or rail.

[0020] FIGS. 2B and 2C are a perspective view and a side view, respectively, of the deflection tube 210. As best shown in FIGS. 2B and 2C, the deflection tube 210 can define a lumen 218 configured to receive the pull-wire 212 (shown in dashed line). The deflection tube 210 can further include a flexure portion 220 configured to bend or deflect in response to movement of the pull-wire 212, as described previously with reference to FIG. 2A. The flexure portion 220 can include one or more segments 222 and/or one or more corresponding channels or gaps 224 between individual segments 222. The gaps 224, for example, can be laser-cut from the deflection tube 210, or formed using another suitable technique, such that individual ones of the gaps 224 can be positioned between individual ones of the segments 222, extend at least partially through the deflection tube 210. and/or extend at least partially about a longitudinal axis X of the deflection tube 210. Each of the gaps 224 can be configured to directionally reduce a resistance to bending/deflection of the deflection tube 210, as described in detail below with reference to FIG. 2D. Accordingly, the gaps 224 can be configured to allow the flexure portion 220 to bend or deflect in response to movement of the pull-wire 212, as described above with reference FIG. 2A.

[0021] The bending/deflection of the flexure portion 220 can bring individual ones of the segments 222 (e.g., immediately adjacent ones of the segments 222) tow ard each other and, in some cases, into contact with one another, thereby at least partially or fully preventing further bending/deflection of the flexure portion 220. Accordingly, a number of the segments 222, a number of the gaps 224, a spacing between individual ones of the segments 222 and/or individual ones of the gaps 224, and/or one or more dimensions of the segments 222 and/or the gaps 224 (e.g., height, width, depth, etc.) can at least partially define a range of angles (e.g., the angle A of FIG. 2A) through which the flexure portion 220 can be bent/deflected. In the illustrated embodiment, for example, the flexure portion 220 includes fifteen segments 222 (only three labeled for the sake of illustrative clarity) and fifteen gaps 224 (only two labeled for the sake of illustrative clarity). In other embodiments, however, the flexure portion 220 can include more or fewer segments 222 and/or gaps 224, such as at least one, five, ten, twenty, thirty, any number therebetw een, or another suitable number of segments 222 and/or gaps 224. In these and other embodiments, the number of segments 222 can be less than, equal to, or greater than the number of gaps 224.

[0022] FIG. 2D is a side view of the system 200 in the first state 201. The deflection tube 210 can be configured such that all or a subset of the gaps 224 (only one gap 224 is labeled in FIG. 2D) face a same direction D, e.g., radially outwardly from a longitudinal axis Y of the catheter 202 and/or toward an inner surface 226 of the catheter 202. As described above with reference to FIGS. 2B and 2C, the gaps 224 can directionally reduce the resistance to bending of the deflection tube 210 in the direction D. Accordingly, positioning the gaps 224 to face radially outwardly from the longitudinal axis Y and toward the inner surface 226 can allow bending/deflection of the deflection tube 210 (e.g., in the direction D) to cause a corresponding bending/deflection of the catheter 202 (e.g., in the direction D) without or substantially without the deflection tube 210 being coupled to the catheter 202. In other embodiments, the gaps 224 can be positioned to face another direction and/or the deflection tube 210 can act against the sheath 216 to cause bending/deflection of the catheter 202. In these and other embodiments, all or a portion of the deflection tube 210 can be coupled to the catheter 202 (e.g., using an adhesive) so the bending/deflection of the deflection tube 210 further enhances bending/deflection of the catheter 202.

[0023] FIGS. 3A-3E illustrate various stages of an operation to implant an adjustable interatrial shunt 330 (“shunt 330”-shown schematically) using the system 200 in accordance with embodiments of the present technology. Referring first to FIG. 3A, the system 200 can be intravascularly delivered within a patient and positioned in the RA of the patient, at or near the septal wall S, and the shunt 330 can be carried within the lumen 204 of the catheter 202. In the embodiment illustrated in FIG. 3 A, the shunt 330 includes a first body or can 332, a second body or can 334, and one or more wires 336 extending therebetween. In other embodiments, the shunt 330 can include more or fewer cans and/or have other suitable configurations. The shunt 330 (e.g., the second can 334) can be coupled to a delivery tool or pusher 338 positioned within the lumen 204. The pusher 338 can include a coupling member 340 that is threaded or otherwise configured to allow the coupling member 340 to be releasably coupled to the shunt 330.

[0024] Referring next to FIG. 3B, the system 200 can be transitioned from the first state 201 (FIG. 3 A) to the second state 203 (FIG. 3B) by actuating the pull- wire 212 to cause the deflection tube 210 to bend or deflect and thereby cause the catheter 202 to bend or deflect, as described previously with reference to FIGS. 2A-2D. In at least some embodiments, for example, transitioning the system 200 toward and/or to the second state 203 can orient the distal portion 208a of the catheter 202 to be at least generally perpendicular or perpendicular to the septal wall S, which is expected to improve the deployment and/or implantation of the shunt 330 through the septal wall S. Additionally, or alternatively, transitioning the system 200 toward and/or to the second state 203 can set the curvature of at least the deflection tube 210 and thereby allow the catheter 202 and/or the shunt 330 to be moved (e.g., relative to the deflection tube 210, the septal wall S, or another portion of the patient) without or substantially without changing the curvature of at least the flexion portion 208b of the catheter 202. For example, with the curvature of the deflection tube 210 set, the catheter 202 can be advanced over the deflection tube 210 while mirroring, or at least generally following, the set curvature of the deflection tube 210. In these and other embodiments, at least a portion of the shunt 330 (e.g., the first can 332) can move with the catheter 202 as the catheter 202 is bent/deflected. such that bending/deflecting the catheter 202 can reorient the shunt 330 within the patient, e.g., relative to the septal wall S.

[0025] Referring to FIG. 3C, with the catheter 202 in the second state 203. the catheter 202 can be advanced toward and/or at least partially through the septal wall S until at least a portion of the catheter 202 extends through the septal wall S and/or into the LA of the patient. For example, the catheter 202 can be advanced over the deflection tube 210 as described above with reference to FIG. 3B. The catheter 202 can maintain a selected curvature (e.g., the set curvature described with reference to FIG. 3B) relative to patient anatomy (e.g., the septal wall S) while being advanced toward and/or through the septal wall S. This, in turn, is expected to keep the distal portion 208a at least generally perpendicular or perpendicular relative to the septal wall S. Maintaining the selected/desired curvature of the catheter 202 relative to the septal wall S is expected to reduce distension of the septal wall S during insertion and/or improve the navigability of the system 200 in relatively small atria.

[0026] In some embodiments, the catheter 202 can be advanced along the deflection tube 210 toward and/or at least partially through the septal wall S, e.g., while maintaining a constant or at least generally constant distance D between at least the proximal portion 208c of the catheter 202 and the septal wall S. Advancing the catheter 202 along the deflection tube 210 can increase the length of the distal portion 208a and/or extend the shunt 330 through (e.g.. further through) the septal wall S. Because the deflection tube 210 can maintain the selected/set curvature, the catheter 202 can be advanced over the deflection tube 210 while maintaining or at least substantially maintaining the curvature of the deflection tube 210. In the illustrated embodiment, for example, the catheter 202 is advanced along the deflection tube 210 without or substantially without changing a curvature of the flexion portion 208b such that the distal portion 208a remains perpendicular or at least substantially perpendicular to the septal wall S. Maintaining the same selected curvature of the catheter 202 relative to the septal w all S during advancement of the catheter 202 over the deflection tube 210, and/or maintaining the distance D between at least the proximal portion 208c and the septal wall S during the advancement of the catheter 202, is expected to reduce or prevent distension of the septal wall S during insertion and/or improve the navigability of the system 200 in relatively small atria.

[0027] Referring to FIG. 3D, the pusher 338 can be advanced through the lumen 204 to extend at least a portion of the shunt 330 (e.g., at least a portion of the first can 332) out from the lumen 204, beyond the septal wall S and/or into the LA. As shown in FIG. 3D, because of the set curvature of the catheter 202 and/or the deflection tube 210. the shunt 330 can be delivered through the septal wall S perpendicular or at least generally perpendicular to the septal wall S.

[0028] Referring to FIG. 3E, the catheter 202 can be withdrawn over the deflection tube 210 to deploy the second can 334 from within the lumen 204 into the RA. The pusher 338 can be held in place relative to the catheter 202 to prevent, or at least partially prevent, the shunt 330 from moving during the withdrawal of the catheter 202. The deflection tube 210 can maintain the selected curvature relative to patient anatomy (e.g., the septal wall S) and/or another portion of the catheter 202 while the catheter 202 is retracted along the deflection tube 210, such that the distal portion 208a and/or the second can 334 remains perpendicular or at least substantially perpendicular to the septal wall S. After the second can 334 has been positioned within the RA, the pusher 338 can be uncoupled from the shunt 330 and the system can be removed from the patient with the shunt 330 implanted across the septal wall S.

[0029] FIGS. 4A and 4B is a partially schematic side view of another interatrial shunt delivery system 400 (“system 400") configured in accordance with embodiments of the present technology. The system 400 can include at least some elements that are at least generally similar or identical in structure and/or function to the system 200 (FIGS. 2A-2D). For example, the system 400 includes the catheter 202 and the catheter 202 is transitionable toward and/or to the second state 203. The system 400 further includes a deflection assembly 406 slidably positioned within the lumen 204 of the catheter 202. Compared to the deflection assembly 206 (FIG. 2A), the deflection assembly 406 occupies a greater proportion of the lumen 204. For example, the deflection assembly 406 can occupy up to 50%, 60%, 70%, 80%, 90%, 99%, or even 100% of a cross-sectional area of the lumen 204.

[0030] The deflection assembly 406 can include a hypotube or deflection tube 410 that defines a deflection tube lumen 418 configured to receive the shunt 330 and the pusher 338. e.g., such that the deflection tube 410 is between the shunt 330 and the catheter 202. The deflection tube 410 can be configured to set or maintain a curvature, as described previously herein at least with reference to the deflection tube 210. Because the shunt 330 and the pusher 338 are carried within the deflection tube lumen 418. the shunt 330 and the pusher 338 can be configured to move/bend along with the deflection tube 410. The deflection tube 410 can comprise one or more of the materials described previously with reference to the deflection tube 210. The deflection tube 410 can be actuated via pullwire, as described previously with reference to FIGS. 2A-3E, to transition the catheter 202 toward and/or to the second state 203. Additionally, or alternatively, the deflection tube 410 can comprise one or more shape memory materials (e.g., Nitinol) and be configured to have a predefined or shape-set curvature to which the deflection tube 410 is transitionable in response to the application of energy (e.g., heat energy, laser energy, etc.). In these and/or other embodiments, the catheter 202 can be actuatable via pullwire, a shape-memory effect, and/or one or more other suitable mechanisms configured to cause the catheter 202 to bend or deflect, in addition to or in lieu of the deflection tube 410 being actuatable. In such embodiments, the catheter 202 can be used to set or maintain a curvature, in addition to or in lieu of the deflection tube 410.

[0031] During an implantation procedure, a user can position the catheter 202 and the deflection tube 410 at least partially within and/or through the septal wall S. For example, as shown in FIG. 4A. a distal end/terminus of the deflection tube 410 can be positioned between the RA and the LA. The catheter 202 can extend through the septal wall S and/or into the LA, as show n in FIG. 4A. With the deflection tube 210 and catheter 202 in these positions, the user can retract the catheter 202 proximally over the deflection tube 410 to expose the deflection tube 410 within and/or through the septal wall S, as shown in FIG. 4B. The user can then advance the shunt 330 (via the pusher 338) through the deflection tube lumen 418 into position across the septal wall S. With the shunt 330 in this position, the user can retract the deflection tube 410 proximally to at least partially or fully uncover the shunt 330.

[0032] In some embodiments, rather than retracting the catheter 202 proximally over the deflection tube 410, the user can advance the deflection tube 410 distally from within the catheter 202, e.g.. into the position between the LA and the RA shown in FIG. 4B. The user can then advance the shunt 330 through the deflection tube lumen 410 as described above. In these and/or other embodiments the user can use the catheter 202 or the deflection tube 410 to set a curvature that allows the shunt 330 to pass through the septal wall S in an orientation that is perpendicular, or at least substantially perpendicular, to the septal w all S, as described previously herein at least with reference to FIGS. 3A-3E.

[0033] FIGS. 5 A and 5B is a partially schematic side view of another interatrial shunt delivery system 500 (‘"system 500”) configured in accordance with embodiments of the present technology. The system 500 can include the catheter 202 (FIG. 2) and the deflection assembly 406 (FIGS. 4A and 4B) described previously herein. In the embodiment disclosed in FIGS. 5A and 5B, however, the catheter 202 is positioned within the deflection assembly 406 and carries the shunt 330. As described previously, the deflection assembly 406 can be actuatable (e.g., via a pull wire) and used to set a desired curvature for approaching the septal wall S. The catheter 202 be translated through the deflection assembly 406, e.g., to follow the curvature set by the deflection assembly 406 and cross through the septal wall S, such as shown in FIG. 5A. The implant 330 can then be positioned across the septal wall S and the catheter 202 can be withdrawn (such as shown in FIG. 5B) to leave the shunt 330 positioned across the septal wall S.

Examples

[0034] Several aspects of the present technology are described with reference to the following examples:

1. A method for implanting an interatrial shunt in a patient, the method comprising: advancing an interatrial shunt delivery system into a right atrium of the patient, the interatrial shunt delivery' system including a catheter configured to carry the interatrial shunt and a deflection assembly; setting a curvature of the deflection assembly to flex a portion of the catheter; advancing the catheter over the deflection assembly at least partially through a septal w all of the patient while maintaining the curvature of at least the deflection assembly; and positioning the interatrial shunt at least partially through the catheter and into a left atrium of the patient while maintaining the curvature of at least the deflection assembly.

2. The method of example 1, further comprising retracting the catheter along the deflection assembly at least partially back through the septal wall of the patient while maintaining the curvature of at least the deflection assembly.

3. The method of example 1 or example 2 wherein: the catheter includes a distal portion and a proximal portion; and setting the curvature of the deflection assembly includes moving the distal portion of the catheter relative to the proximal portion of the catheter.

4. The method of example 3 wherein moving the distal portion includes orienting the distal portion to be generally perpendicular to the septal w all of the patient.

-l i 5. The method of any of examples 1-4 wherein extending the interatrial shunt at least partially through the septal wall includes advancing a pusher coupled to the interatrial shunt through the catheter.

6. The method of any of examples 1-5 wherein the deflection assembly includes a deflection tube and a pull-wire coupled to a distal end portion of the deflection tube, and wherein setting the curvature of the deflection assembly includes moving the pull-wire proximally relative to the deflection tube.

7. The method of example 6 wherein the deflection tube includes a plurality of gaps positioned to directionally reduce a resistance to bending of the deflection tube, and wherein moving the pull-wire proximally relative to the deflection tube includes causing the deflection tube to bend about one or more of the plurality of gaps.

8. The method of example 6 or 7 wherein: the deflection tube includes a plurality of segments; individual ones of the plurality of segments are spaced apart from one another by a gap configured to directionally reduce a resistance to bending of the deflection tube; and moving the pull-wire proximally relative to the deflection tube includes causing one or more of the plurality of segments to contact another one of the plurality of segments.

9. The method of any of examples 1-8 wherein the catheter includes a sheath configured to receive at least a portion of the deflection assembly therein, and wherein setting the curvature of the deflection assembly includes causing the deflection assembly to act against the sheath.

10. The method of any of examples 1-9 wherein the catheter includes a sheath configured to receive at least a portion of the deflection assembly therein, the method further comprising positioning at least the portion of the deflection assembly within the sheath before setting the curvature of the deflection assembly. 11. The method of any of examples 1-10 wherein setting the curvature includes setting the curvature to an angle of up to 90 degrees.

12. The method of any of examples 1-11 wherein maintaining the curvature of the deflection assembly includes maintaining a curvature of a corresponding portion of the catheter.

13. The method of any of examples 1-12 wherein extending the interatrial shunt at least partially through the catheter and into a left atrium of the patient includes: extending the interatrial shunt with at least a portion of the catheter parallel to the septal wall, and maintaining a constant distance between the parallel portion of the catheter and the septal wall.

14. The method of any of examples 1-13 wherein the catheter defines a first lumen configured to receive the deflection assembly and the deflection assembly defines a second lumen configured to receive the interatrial shunt, and wherein: positioning the interatrial shunt at least partially through the catheter includes withdrawing the catheter over the deflection assembly.

15. An interatrial shunt delivery system, comprising: a catheter defining a lumen therethrough configured to carry an interatrial shunt, wherein the catheter includes a proximal portion, a distal portion, and a flexion portion between the proximal portion and the distal portion; and a deflection assembly carried within the lumen of the catheter, wherein the deflection assembly is configured to set a curvature of at least the flexion portion of the catheter by causing the catheter to transition between (i) a first state in which the proximal portion, the flexion portion, and the distal portion are at least generally linear and (ii) a second state in which the flexion portion is curved relative to the first state to reorient the distal portion relative to the proximal portion.

16. The interatrial shunt delivery system of example 15 wherein, in the second state, the distal portion is generally perpendicular to the proximal portion. 17. The interatrial shunt delivery system of example 15 or 16 wherein the deflection assembly is configured to cause the distal portion of the catheter to pivot relative to the proximal portion about a center of curvature of the flexion portion.

18. The interatrial shunt delivery system of any of examples 15-17 wherein the deflection assembly includes a deflection tube and a pull-wire, and wherein actuation of the pullwire is configured to bend the deflection tube and thereby change the curvature of the flexion portion of the catheter.

19. The interatrial shunt delivery system of example 18 wherein the deflection tube includes a gap extending at least partially through the deflection tube and at least partially about a longitudinal axis of the deflection tube, and wherein the gap is positioned to directionally reduce a resistance to bending of the deflection tube.

20. The interatrial shunt delivery system of example 18 or 19 wherein the deflection tube includes a plurality of segments, and wherein individual ones of the plurality of segments are (i) spaced apart from one another by a gap extending at least partially through the deflection tube and (ii) positioned to directionally reduce a resistance to bending of the deflection tube.

21. The interatrial shunt delivery system of example 19 or 20 wherein the pull-wire is coupled to a distal end of the deflection tube.

22. The interatrial shunt delivery system of any of examples 15-21 wherein the catheter includes a sheath configured to slidably receive at least a portion of the deflection assembly therein to allow for movement of the catheter and/or the deflection assembly relative to one another.

23. The interatrial shunt delivery system of example 22 wherein the sheath is positioned within the lumen of the catheter.

24. The interatrial shunt delivery system of any of examples 15-23 wherein the lumen of the catheter is a first lumen, and wherein the deflection assembly defines a second lumen configured to receive the interatrial shunt. 25. The interatrial shunt delivery system of any of examples 15-25 wherein the deflection assembly is configured to be positioned between the interatrial shunt and the catheter.

Conclusion

[0035] As one of skill in the art will appreciate from the disclosure herein, various components of the interatrial shunting systems described above can be omitted without deviating from the scope of the present technology. Likewise, additional components not explicitly described above may be added to the interatrial shunting systems without deviating from the scope of the present technology. Accordingly, the present technology is not limited to the configurations expressly identified herein, but rather encompasses variations and alterations of the described systems.

[0036] The above detailed description of embodiments of the technology' are not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Although specific embodiments of, and examples for. the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology as those skilled in the relevant art will recognize. For example, although steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments. For example, although this disclosure has been written to describe devices that are generally described as being used to create a path of fluid communication between the LA and RA, the LV and the right ventricle (RV), or the LA and the coronary' sinus, it should be appreciated that similar embodiments could be utilized for shunts between other chambers of heart or for shunts in other regions of the body.

[0037] Embodiments of the present disclosure may include portions that are radiopaque and/or ultrasonically reflective to facilitate image-guided implantation or image guided procedures using techniques such as fluoroscopy, ultrasonography, or other imaging methods. Embodiments of the system may include specialized delivery catheters/sy stems that are adapted to deliver an implant and/or carry out a procedure. Systems may include components such as guidewires, sheaths, dilators, and multiple delivery catheters. Components may be exchanged via over-the-wire, rapid exchange, combination, or other approaches.

[0038] Unless the context clearly requires otherwise, throughout the description and the examples, the words “comprise,” “comprising,” and the like are to be construed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to." As used herein, the terms “connected,’" “coupled,” or any variant thereof, means any connection or coupling, either direct or indirect, between two or more elements; the coupling of connection between the elements can be physical, logical, or a combination thereof. Additionally, the words “herein,” “above,” “below,” and words of similar import, when used in this application, shall refer to this application as a whole and not to any particular portions of this application. Where the context permits, words in the above Detailed Description using the singular or plural number may also include the plural or singular number respectively. As used herein, the phrase “and/or” as in “A and/or B” refers to A alone, B alone, and A and B. Additionally, the term “comprising” is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with some embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology⁷ can encompass other embodiments not expressly shown or described herein.

Claims

CLAIMS I/'W e claim:

1. A method for implanting an interatrial shunt in a patient, the method comprising: advancing an interatrial shunt delivery system into a right atrium of the patient, the interatrial shunt delivery' system including a catheter configured to carry the interatrial shunt and a deflection assembly; setting a curvature of the deflection assembly to flex a portion of the catheter; advancing the catheter over the deflection assembly at least partially through a septal wall of the patient while maintaining the curvature of at least the deflection assembly; and positioning the interatrial shunt at least partially through the catheter and into a left atrium of the patient while maintaining the curvature of at least the deflection assembly.

2. The method of claim 1, further comprising retracting the catheter along the deflection assembly at least partially back through the septal wall of the patient while maintaining the curvature of at least the deflection assembly.

3. The method of claim 1 wherein: the catheter includes a distal portion and a proximal portion; and setting the curvature of the deflection assembly includes moving the distal portion of the catheter relative to the proximal portion of the catheter.

4. The method of claim 3 wherein moving the distal portion includes orienting the distal portion to be generally perpendicular to the septal wall of the patient.

5. The method of claim 1 wherein extending the interatrial shunt at least partially through the septal wall includes advancing a pusher coupled to the interatrial shunt through the catheter.

6. The method of claim 1 wherein the deflection assembly includes a deflection tube and a pull-wire coupled to a distal end portion of the deflection tube, and wherein setting the curvature of the deflection assembly includes moving the pull-wire proximally relative to the deflection tube.

7. The method of claim 6 wherein the deflection tube includes a plurality of gaps positioned to directionally reduce a resistance to bending of the deflection tube, and wherein moving the pull-wire proximally relative to the deflection tube includes causing the deflection tube to bend about one or more of the plurality of gaps.

8. The method of claim 6 wherein: the deflection tube includes a plurality of segments; individual ones of the plurality of segments are spaced apart from one another by a gap configured to directionally reduce a resistance to bending of the deflection tube; and moving the pull-wire proximally relative to the deflection tube includes causing one or more of the plurality of segments to contact another one of the plurality of segments.

9. The method of claim 1 wherein the catheter includes a sheath configured to receive at least a portion of the deflection assembly therein, and wherein setting the curvature of the deflection assembly includes causing the deflection assembly to act against the sheath.

10. The method of claim 1 wherein the catheter includes a sheath configured to receive at least a portion of the deflection assembly therein, the method further comprising positioning at least the portion of the deflection assembly within the sheath before setting the curvature of the deflection assembly.

11. The method of claim 1 wherein setting the curvature includes setting the curvature to an angle of up to 90 degrees.

12. The method of claim 1 wherein maintaining the curvature of the deflection assembly includes maintaining a curvature of a corresponding portion of the catheter.

13. The method of claim 1 wherein extending the interatrial shunt at least partially through the catheter and into a left atrium of the patient includes: extending the interatrial shunt with at least a portion of the catheter parallel to the septal wall, and maintaining a constant distance between the parallel portion of the catheter and the septal wall.

14. The method of claim 1 wherein the catheter defines a first lumen configured to receive the deflection assembly and the deflection assembly defines a second lumen configured to receive the interatrial shunt, and wherein: positioning the interatrial shunt at least partially through the catheter includes withdrawing the catheter over the deflection assembly.

16. The interatrial shunt delivery system of claim 15 wherein, in the second state, the distal portion is generally perpendicular to the proximal portion.

17. The interatrial shunt delivery system of claim 15 wherein the deflection assembly is configured to cause the distal portion of the catheter to pivot relative to the proximal portion about a center of curvature of the flexion portion.

18. The interatrial shunt delivery system of claim 15 wherein the deflection assembly includes a deflection tube and a pull-wire, and wherein actuation of the pull-wire is configured to bend the deflection tube and thereby change the curvature of the flexion portion of the catheter.

19. The interatrial shunt delivery' system of claim 18 wherein the deflection tube includes a gap extending at least partially through the deflection tube and at least partially about a longitudinal axis of the deflection tube, and wherein the gap is positioned to directionally reduce a resistance to bending of the deflection tube.

20. The interatrial shunt delivery system of claim 18 wherein the deflection tube includes a plurality of segments, and wherein individual ones of the plurality of segments are (i) spaced apart from one another by a gap extending at least partially through the deflection tube and (ii) positioned to directionally reduce a resistance to bending of the deflection tube.

21. The interatrial shunt delivery system of claim 19 wherein the pull-wire is coupled to a distal end of the deflection tube.

22. The interatrial shunt delivery system of claim 15 wherein the catheter includes a sheath configured to slidably receive at least a portion of the deflection assembly therein to allow for movement of the catheter and/or the deflection assembly relative to one another.

23. The interatrial shunt delivery system of claim 22 wherein the sheath is positioned within the lumen of the catheter.

24. The interatrial shunt delivery system of claim 15 wherein the lumen of the catheter is a first lumen, and wherein the deflection assembly defines a second lumen configured to receive the interatrial shunt.

25. The interatrial shunt delivery system of claim 15 wherein the deflection assembly is configured to be positioned between the interatrial shunt and the catheter.