WO2025255265A1

WO2025255265A1 - Delivery systems for implantable shunting systems and associated devices and methods

Info

Publication number: WO2025255265A1
Application number: PCT/US2025/032324
Authority: WO
Inventors: Jace Valls
Original assignee: Shifamed Holdings LLC
Current assignee: Shifamed Holdings LLC
Priority date: 2024-06-06
Filing date: 2025-06-04
Publication date: 2025-12-11
Anticipated expiration: 2026-12-06

Abstract

The present technology generally relates to a catheter. In some embodiments, the catheter includes a hypotube, one or more pull wires, and a covering. The hypotube can have a distal end portion, a first region, and a second region that define a lumen and gaps extending between the first and second regions. The pull wires can extend through corresponding ones of the gaps, and can be actuated to transform the catheter between a neutral state and steered states. The covering can be disposed around the hypotube and the pull wires, and can include liquid crystal polymer fibers. When in the neutral state, the hypotube and the pull wires extend along a longitudinal axis. When in one of the steered states, the hypotube and the pull wires extend along a curve. Embodiments of the catheter described herein can be low-profile, radially compliant, and/or steerable.

Description

DELIVERY SYSTEMS FOR IMPLANTABLE SHUNTING SYSTEMS

AND ASSOCIATED DEVICES AND METHODS

CROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] The present application claims priority to U.S. Provisional Patent Application No. 63/656,971, filed June 6, 2024, the disclosure of which is incorporated by reference herein 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. Despite advancements in shunting system technology, however, designing systems that can reliably and relatively non-invasively delivered and deployed across a target structure, such as a septum in the heart, remains a challenge.

BRIEF DESCRIPTION OF THE DRAWINGS

[0004] Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed on illustrating clearly the principles of the present technology'. Furthermore, components can be show n as transparent in certain view s for clarity of illustration only and not to indicate that the component is necessarily transparent. Components may also be shown schematically.

[0005] 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.

[0006] FIG. 2A is a perspective view of a portion of a catheter including a hypotube configured in accordance with select embodiments of the present technology'. [0007] FIG. 2B is an enlarged perspective view of the catheter of FIG. 2A.

[0008] FIG. 3 is an enlarged side view of the catheter of FIG. 2 A.

[0009] FIG. 4 is an enlarged perspective view of a proximal end portion of the catheter of

FIG. 2A.

[0010] FIG. 5 is an enlarged perspective view of a distal end portion of the catheter of FIG. 2A.

[0011] FIG. 6 illustrates bidirectional steering of the catheter of FIG. 2A in accordance with select embodiments of the present technology.

[0012] FIGS. 7A and 7B are enlarged side views of the catheter of FIG. 2A in a neutral state and in a steered state, respectively, and configured in accordance with select embodiments of the present technology.

DETAILED DESCRIPTION

[0013] The present technology is generally directed to delivery systems for implantable shunting systems and associated devices and methods. The disclosed delivery systems can include catheters that are low-profile, radially compliant, and/or steerable. In some embodiments, for example, a catheter includes a hypotube, one or more pull wires coupled to the hypotube, and a covering disposed around the hypotube and the one or more pull wires. The hypotube can have a distal end portion, a first region extending from the distal end portion, and a second region extending from the distal end portion. The first and second regions can define (i) a lumen and (ii) one or more gaps extending from distal end portion and between the first and second regions. The one or more pull wires can be coupled to the distal end portion of the hypotube and extend through corresponding ones of the gaps. The one or more pull wires are configured to be actuated to transform the catheter between a neutral state and one or more steered states. When the catheter is in the neutral state, the hypotube and the one or more pull wires can extend along a longitudinal axis of the catheter. When the catheter is in one of the one or more steered states, the hypotube and the one or more pull wires can extend along a curve.

[0014] 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. 1-7B.

[0015] 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.

[0016] Reference throughout this specification to relative terms such as, for example, “substantially,” “approximately,” and “about” are used herein to mean the stated value plus or minus 10%.

[0017] 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 chamber (e.g., a left atrium of a heart) and a second chamber (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, between other parts of the cardiovascular system, or between other parts of the body. For example, any of the shunts described herein, including those referred to as “interatrial,” may nevertheless be used and/or modified to shunt between the left atria and the coronary sinus, or between the right pulmonary vein and the superior vena cava. Moreover, while the disclosure herein primarily describes medical devices for shunting blood in the heart, the present technology can be readily adapted for medical devices used to shunt other fluids — for example, devices used for aqueous shunting or cerebrospinal fluid shunting. The present technology may also be adapted to a variety of implanted medical devices in addition to shunts.

[0018] 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 102 in the septal wall S between the left atrium (LA) and the right atrium (RA). Most interatrial shunts (e.g., the shunt 102) 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 102, or another interatrial shunt, can be placed in the septal wall using a shunt delivery system, such as the delivery' system described below with reference to FIGS. 2A-7B.

A. Select Embodiments of Hypotubes for Implantable Medical Device Delivery Systems

[0019] FIG. 2A is a perspective view of a portion of a catheter 200 including a hypotube 210 configured in accordance with select embodiments of the present technology. The catheter 200 can be part of an implantable medical device delivery system, e.g., an interatrial shunt delivery system for implanting an interatrial shunt in the heart of a patient (not shown). In some embodiments, the hypotube 210 can extend between a proximal end portion 202a and a distal end portion 202b along a longitudinal axis A-A. In some embodiments, the distal end portion 202b of the hypotube 210 can have a generally annular shape. The catheter 200 can also include a first pull wire 222, a second pull wire 224, and a covering (not shown in FIG. 2A, but shown in FIG. 3). The catheter 200 can additionally include one or more liners (not shown) disposed along the inner surface of the hypotube 210 and/or the outer surface of the hypotube 210.

[0020] As shown in FIG. 2A, the hypotube 210 can have a generally elongate, cylindrical form factor that extends along the longitudinal axis A-A and defines a lumen 230 therethrough having a diameter D. When the hypotube 210 is in a neutral or non-radially expanded state (as shown in FIG. 2A), the diameter D can be about 0.1 in, 0.15 in, 0.2 in, 0.25 in, 0.3 in, 0. 1-0.3 in, or other diameters. The hypotube 210 can be composed of metal, plastic, or other suitable materials, and can have a sufficient stiffness such that the hypotube 210 can be pushed (e.g., through blood vessels) without buckling. The hypotube 210 can be manufactured via laser cutting, additive manufacturing (e.g., 3D printing), and/or other suitable manufacturing techniques. For example, the hypotube 210 can be laser cut from a single piece or sheet of metal. The length L of the hypotube 210 can be about 0.5 in, 1 in, 1.5 in, 2 in, 2.5 in, 3 in, 3.5 in, 0.5- 3 in, or other lengths.

[0021] The hypotube 210 can include a distal end portion 212a, a first region 212b, and a second region 212c. The first region 212b and the second region 212c can each have a generally half-cylindrical shape that extends from the distal end portion 212a towards the proximal end portion 202a of the catheter 200. In particular, the first region 212b extends along a first side or a first half of the catheter 200, and the second region 212c extends along a second side or a second half of the catheter 200. The first region 212b and the second region 212c each include a plurality of rib segments 214 that extend bidirectionally (e.g., toward the first pull wire 222 and the second pull wire 224) and circumferentially (e.g., about the lumen 230). The rib segments 214 of the first region 212b extend toward and face corresponding ones of the rib segments 214 of the second region 212c such that the rib segments 214 are arranged like a ribcage on both sides of the hypotube 210.

[0022] As better shown in FIG. 2B, which is an enlarged perspective view of the catheter 200, the first region 212b and the second region 212c are connected only at the distal end portion 212a. In other words, the first region 212b and the second region 212c comprise cantilevered structures that extend on opposite sides of a longitudinal plane of the hypotube 210. Therefore, the rib segments 214 of the first region 212b do not contact the rib segments 214 of the second region 212c, and instead leave gaps therebetween for the first pull wire 222 and the second pull wire 224. In other embodiments, the first region 212b and the second region 212c are additionally or alternatively connected elsewhere, such as at one or more of the rib segments 214 and/or at the proximal end portion 202a. In such embodiments, the hypotube 210 can include one or more grooves or channels through which the first pull wire 222 and/or the second pull wire 224 can extend. For example, the first region 212b and the second region 212c can form a unitary structure in which the first region 212b and the second region 212c are not cantilevered from the distal end portion 212a.

[0023] Rib segments 214 that extend in the same direction define a plurality⁷ of splines or grooves 216. In the illustrated embodiment, for example, the rib segments 214 that extend in opposite directions (e.g.. toward the first pull wire 222 and the second pull wire 224) alternate along the longitudinal axis A-A such that the grooves 216 extending in opposite directions also alternate along the longitudinal axis A-A. Adjacent grooves 216 can form an overlapping spine pattern in which, when viewed along the longitudinal axis A-A, the grooves 216 extending in opposite directions overlap.

[0024] The first pull wire 222 and the second pull wire 224 can each be attached to the hypotube 210 at the distal end portion 212a. In particular, the first pull wire 222 and the second pull wire 224 can be attached at opposite sides of the distal end portion 212a such that they extend tow ard the proximal end portion 202a between the rib segments 214 along opposite sides of the hypotube 210 (e.g., positioned 180 degrees apart around the lumen 230). The first pull wire 222 and the second pull wire 224 can be held under tension to maintain their position (e.g., flush with the rib segments 214) and/or shape (e.g., linear).

[0025] FIG. 3 is an enlarged side view of the distal end portion 202b of the catheter 200. As shown, the catheter 200 can include a covering 340 around the hypotube 210, the first pull wire 222, and the second pull wire 224 (obscured from view in FIG. 3). In some embodiments, the covering 340 is composed of a flexible and/or expandable material. For example, the covering 340 can include a tensile fiber (e.g., liquid crystal polymer or other polymer) coiled around the hypotube 210, the first pull wire 222, and the second pull wire 224. When the catheter 200 is enclosed by a jacket or other sheath, and the first and second pull wires 222, 224 are pulled to steer the catheter 200 (as discussed further herein), the covering 340 can prevent the first and second pull wires 222, 224 from ripping through the jacket during deflection. Enclosing the catheter 200 and/or performing a reflow operation can ensure that adding the covering 340 does not significantly increase the profile of the catheter 200.

[0026] Also illustrated in FIG. 3 is a weld 320 between the hypotube 210 and the first pull wire 222. The weld 320 can keep the first pull wire 222 attached to the hypotube 210. While obscured from view, another weld can be included to keep the second pull wire 224 attached to the hypotube 210. The weld 320 is discussed in further detail below' with reference to FIG. 5.

[0027] FIG. 4 is an enlarged perspective view' of the proximal end portion 202a of the catheter 200. The covering 340 is omitted in FIG. 4 for illustrative purposes only. As shown, the first and second regions 212b, 212c are not in contact at the proximal end portion 202a. Instead, the first and second regions 212b, 212c maintain a first gap 412a and a second gap 412b that extend linearly from the distal end portion 212a along the longitudinal axis and in which the first and second pull wires 222, 224 are positioned, respectively. Also, while the first and second pull wires 222, 224 are illustrated as cut off close to the hypotube 210, it will be appreciated that the first and second pull wires 222, 224 can extend to shorter or longer lengths beyond the hypotube 210.

[0028] The thickness T1 of the hypotube 210 can be about 0.005 in, 0.006 in, 0.007 in, 0.008 in, 0.009 in, 0.005-0.009 in, or other thicknesses. Each of the first gap 412a and the second gap 412b can have a width W of about 0.006 in, 0.008 in, 0.01 in, 0.012 in, 0.014 in, 0.006- 0.014 in, or other values. The first pull wire 222 and the second pull wire 224 can be sized to fit in the first gap 412a and the second gap 412b, respectively. The thickness T2 of each rib segment 214 adjacent the gaps 412a, 412b can be about 0.01 in, 0.02 in, 0.03 in, 0.04 in, 0.05 in, 0.01- 0.05 in, or other values. The gap G between adjacent rib segments 214 adjacent the gaps 412a, 412b can be about 0.03 in, 0.04 in, 0.05 in, 0.06 in, 0.07 in, 0.03-0.07 in, or other values. The ratio G2:T2 can be about 1, 1.2, 1.4, 1.6, 1.8, 2, 1-2, or other ratios.

[0029] FIG. 5 is an enlarged perspective view of the distal end portion 202b of the catheter 200. Again, the covering 340 is omitted for illustrative purposes only. The distal end portion 212a of the hypotube 210 can include a first notch or slot 520 in which a distal end of the first pull wire 222 can be disposed, as shown. The first slot 520 can provide sufficient space and surface area for the weld 320 (FIG. 3) to be formed for coupling the first pull wire 222 to the distal end portion 212a. The first slot 520 can also define the beginning and position of the first gap 412a. The distal end portion 212a can also include a second notch (obscured from view) for receiving the second pull wire 224 and a corresponding weld, and for defining the beginning and position of the second gap 412b. In some embodiments, the weld 320 is supplemented or replaced by solder, adhesives, fasteners, or other suitable coupling mechanisms.

[0030] In some embodiments, the hypotube 210 includes only one of the first gap 412a or second gap 412b such that the hypotube 210 can radially expand in a C-shape when receiving and delivering an implant or other medical device. In some embodiments, the distal end portion 212a is split into two or more parts such that the hypotube 210 comprises two or more completely separate components. This is expected to further increase the radial compliance of the catheter. The covering 340 and/or the liner on the outside of the hypotube 210 can keep the two or more separate components together to maintain the general shape of the lumen 230.

[0031] In some embodiments, the rib segments 214 and the grooves 216 are arranged in patterns other than the illustrated pattern. For example, the rib segments 214 of the first region 212b and the rib segments 214 of the second region 212c that extend toward the same one of the first pull wire 222 or the second pull wire 224 in a staggered arrangement such that the rib segments 214 do not face one another. In another example, the rib segments 214 of the first region 212b and the rib segments 214 of the second region 212c can be in an overlapping or interlocking arrangement, which can help prevent implants from piercing through the catheter 200. Different patterns, arrangements, and relative dimensions of the rib segments 214 and the grooves 216 are expected to provide different degrees of flexibility to the catheter 200.

[0032] In some embodiments, the catheter 200 includes only a single pull wire or more than two pull wires. As discussed further herein, the number of pull wires can correspond to the number of directions that the catheter 200 can be steered. Also, in embodiments in which the catheter 200 includes multiple pull wires, the pull wires can be evenly spaced apart around the lumen 230 (as shown in FIGS. 2-5) or unevenly spaced apart around the lumen 230.

[0033] The catheter 200 described and illustrated herein exhibits one or more features (and/or a combination thereof) that are expected to be advantageous over conventional catheters/delivery systems. First, the catheter 200 can be low-profile. Because the first pull wire 222 and the second pull wire 224 are positioned within the first gap 412a and the second gap 412b as opposed to, for example, on the exterior of the hypotube 210, the outer diameter of the catheter 200 is unaffected (e.g., not increased) by the presence of the first and second pull wires 222, 224. In other words. during operation of the catheter 200, the first pull wire 222 and the second pull wire 224 remain within the outer diameter of the hypotube 210. Also, the thicknesses of the hypotube 210 and of the first and second pull wires 222, 224 can be selected to maximize the diameter D of the lumen 230 while minimizing the outer diameter of the catheter 200.

[0034] Second, the catheter 200 can be radially compliant. Because the first region 212b and the second region 212c of the hypotube 210 are disconnected other than at the distal end portion 212a at the distal end portion 202b, the hypotube 210 essentially comprises two free ends at the proximal end portion 202a of the catheter 200. Also, the covering 340 can be composed of a flexible and/or expandable material, as discussed above with reference to FIG. 3. Therefore, the diameter D of the lumen 230 is not restrained, but can expand in response to a shunt or other medical device being delivered through the lumen 230. In some embodiments, the diameter D of the lumen 230 can increase from its base diameter (shown in FIGS. 2-5) by about 5%, 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 5-50%, or more without incurring permanent deformation or damage to the hypotube 210. Radial compliance not only allows implants (or other medical devices) of larger of cross-sectional dimensions to be delivered through the catheter 200, but also allows implants to be delivered in various orientations and states (e.g., bent, twisted) as needed.

[0035] Third, the catheter 200 can be steerable. As discussed in further detail below with reference to FIGS. 6-7B, the first pull wire 222 and/or the second pull wire 224 can be operated (e.g., pulled on) to steer the catheter 200 towards a desired direction. Also, the grooves 216 between the rib segments 214. and their patterns (which can be varied), allow the hypotube 210 to bend without incurring excessive stress or material deformation. Steering the catheter 200 is expected to facilitate a more reliable, effective, and safe delivery of the implant or other medical device. B. Methods of Operating Delivery Systems

[0036] FIG. 6 illustrates bidirectional steering of the catheter 200 in accordance with select embodiments of the present technology. The covering 340 is omitted for illustrative purposes only. In operation, the catheter 200 can be configured to be transformable between a neutral state, a first steered state, and a second steered state by selectively pulling on the first pull wire 222 or the second pull wire 224 at the proximal end portion 202a by various degrees. The catheter 200 can be in the neutral state when neither the first pull wire 222 nor the second pull wire 224 is pulled. When the catheter 200 is in the neutral state, the catheter 200 extends linearly along the longitudinal axis A- A, as shown in FIG. 6.

[0037] The catheter 200 can be in the first steered state when the first pull wire 222 is pulled by a greater degree than the second pull wire 224. Pulling the first pull wire 222 pulls one side (the left side in FIG. 6) of the distal end portion 212a of the hypotube 210, which can result in bringing adjacent ones of the rib segments 214 on the side of the first pull wire 222 (on the left side in FIG. 6) closer together and decreasing the widths of the grooves 216 on the side of the first pull wire 222. Conversely, adjacent ones of the rib segments 214 on the side of the second pull wire 224 (on the right side in FIG. 6) may grow farther apart and the widths of the grooves 216 on the side of the second pull wire 224 may increase. Therefore, the catheter 200 can bend or temporarily deform or flex to extend along curve SI, which represents the maximum deformation of the catheter 200 (e.g., without permanent damage to the hypotube 210). Pulling the first pull wire 222 by varying degrees can position the catheter 200 to extend along varying curves between the longitudinal axis A A and the curve SI. The proximal end portion 202a of the catheter 200, however, can remain relatively fixed in position such that only the distal end portion 202b of the catheter 200 (and thus the distal end portion 212a of the hypotube 210) swings.

[0038] The catheter 200 can be in the second steered state when the second pull wire 224 is pulled by a greater degree than the first pull wire 222. Pulling the second pull wire 224 pulls one side (the right side in FIG. 6) of the distal end portion 212a of the hypotube 210, which can result in bringing adjacent ones of the rib segments 214 on the side of the second pull wire 224 (on the right side in FIG. 6) closer together and decreasing the widths of the grooves 216 on the side of the second pull wire 224. Conversely, adjacent ones of the rib segments 214 on the side of the first pull wire 222 (on the left side in FIG. 6) may grow farther apart and the widths of the grooves 216 on the side of the first pull wire 222 may increase. Therefore, the catheter 200 can bend or temporarily deform or flex to extend along curve S2, which represents the maximum deformation of the catheter 200 (e.g., without permanent damage to the hypotube 210). Pulling the second pull wire 224 by varying degrees can position the catheter 200 to extend along varying curves between the longitudinal axis A-A and the curve S2. The proximal end portion 202a of the catheter 200, however, can remain relatively fixed in position such that only the distal end portion 202b of the catheter 200 (and thus the distal end portion 212a of the hypotube 210) swings.

[0039] In the illustrated embodiment, the catheter 200 of the illustrated embodiment includes two pull wires, allowing bidirectional steering. Also, the first and second pull wires 222, 224 are positioned on opposite sides of the hypotube 210 such that the catheter 200 can be steered in two opposing directions, as shown by the curves SI and S2 in FIG. 6. In other embodiments, however, the catheter 200 can include one, three, four, five, or more pull wires. The number of pull wires can correspond to the number of directions that the catheter 200 can be steered. Also, in embodiments in which the catheter 200 includes multiple pull wires, the pull wires can be evenly spaced apart (e.g., as shown in FIGS. 2-6) or unevenly spaced apart to allow steering in desired sets of directions.

[0040] When configuring the catheter 200 to the first or second steered states, the first and second pull wires 222, 224 can have tendencies to “pop out” of the first and second gaps 412a, 412b, respectively, and assume a linear shape due to the tension. To prevent this, which can rupture the jacket or other sheath enclosing the catheter 200 during operation, the covering 340 and/or the one or more liner materials can keep the first and second pull wires 222, 224 within the first and second gaps 412a, 412b, respectively, such that the first and second pull wires 222, 224 curve with the hypotube 210. In particular, the covering 340 can be strong but flexible enough to keep the first and second pull wires 222, 224 in place without adding too much additional thickness to the catheter 200.

[0041] FIGS. 7A and 7B are enlarged side views of the catheter 200 in the neutral state and in the first steered state, respectively, and configured in accordance with select embodiments of the present technology'. Referring first to FIG. 7 A, the hypotube 210 and the covering 340 are both oriented straight such that the catheter 200 extends along the longitudinal axis A-A. And while the first and second pull wires 222, 224 are obscured from view, they are not pulled such that the catheter is in the neutral state. Referring next to FIG. 7B, the hypotube 210 and the covering 340 are bent such that the catheter 200 extends along the curve SI. And while the first and second pull wires 222, 224 are obscured from view, the first pull wire 222 can be in a pulled state such that the catheter 200 is in the first steered state.

[0042] The catheter 200 can be used for delivering a medical device (e g., an interatrial shunt or other implant) to a patient. For example, the method of delivery can include advancing the catheter 200 into a right atrium of the patient, pulling one of the pull wires 222, 224 to configure the catheter 200 from a neutral state to a steered state, advancing the catheter 200 at least partially through a septal wall of the patient while maintaining the catheter in the steered state, and extending the medical device at least partially through the lumen 230 and into a left atrium of the patient while maintaining the catheter 200 in the steered state. In some embodiments, extending the medical device through the lumen 230 radially expands the hypotube 210 of the catheter 200. Afterwards, the method can further include retracting the catheter 200 at least partially back through the septal wall of the patient while maintaining the catheter 200 in the steered state.

[0043] It will be appreciated that the features described and illustrated herein need not be combined in a single embodiment of the present technology. In other words, embodiments of the present technology can include a catheter that includes only one or two of (i) having a low profile, (ii) being radially compliant, and (iii) being steerable. For example, a catheter can include the hypotube 210 and the covering 340 (and/or liners) to be low-profile and radially compliant, but not steerable. In another example, a catheter can include a hypotube with no gaps (e.g., the first gap 412a and the second gap 412b) and the first and second pull wires 222, 224 such that the catheter is low-profile and steerable, but not (or at least not as) radially compliant.

C. Additional Examples

[0044] Several aspects of the present technology are set forth in the following examples:

1. A catheter, comprising: a hypotube having a distal end portion, a first region extending from the distal end portion, and a second region extending from the distal end portion, wherein the first and second regions define (i) a lumen and (ii) one or more gaps extending from distal end portion and between the first and second regions; one or more pull wires coupled to the distal end portion of the hypotube and extending through corresponding ones of the gaps, wherein the one or more pull wires are configured to be actuated to transform the catheter between a neutral state and one or more steered states; and a covering disposed around the hypotube and the one or more pull wires, wherein the covering includes liquid crystal polymer fibers.

2. The catheter of example 1 wherein the one or more gaps comprise (i) a first gap extending along a first side of the hypotube and (ii) a second gap extending along a second side of the hypotube opposite the first side, and wherein the one or more pull wires comprise (i) a first pull wire coupled to the first side of the distal end portion and extending through the first gap and (ii) a second pull wire coupled to the second side of the distal end portion and extending through the second gap.

3. The catheter of example 1 or example 2 wherein the one or more pull wires are welded to the distal end portion of the hypotube.

4. The catheter of any of examples 1-3 wherein the one or more pull wires are configured to remain within an outer diameter of the hypotube.

5. The catheter of any of examples 1-4 wherein each of the first region and the second region comprises a plurality of rib segments extending circumferentially around the lumen and towards the one or more gaps.

6. The catheter of example 5 wherein adjacent ones of the rib segments define a plurality of grooves forming an overlapping spline pattern.

7. The catheter of example 5 wherein a ratio between (i) a thickness of each rib segment along the longitudinal axis and (ii) a distance between adjacent ones of the rib segments along the longitudinal axis is between 1 : 1-1 :2.

8. The catheter of any of examples 1-7 wherein, when the catheter is in the neutral state, a diameter of the lumen is between 0. 1-0.3 in. 9. The catheter of any of examples 1-8 wherein, when the catheter is in the neutral state, each of the one or more gaps has a width between 0.006-0.014 in.

10. A catheter, comprising: a hypotube having: a distal end portion, a first region extending from the distal end portion and having first ribs, and a second region extending from the distal end portion and having second ribs, wherein the first ribs and the second ribs collectively form a lumen extending through the hypotube, and wherein the first ribs are separated from the second ribs by a gap extending between the first region and the second region; a pull wire operably coupled to the distal end portion of the hypotube and extending through the gap between the first region and the second region, wherein the pull wire is configured to be manipulated to change an orientation of the catheter; and an outer membrane positioned around the hypotube and the pull wire.

11. The catheter of example 10 wherein the first region is not directly coupled to the second region at any portion of the first and second regions having the first and second ribs.

12. The catheter of example 10 or example 11 wherein the first ribs extend about halfway around a circumference of the lumen, and wherein the second ribs extend about halfway around the circumference of the lumen.

13. The catheter of any of examples 10-12 wherein a diameter of the lumen is adjustable.

14. The catheter of example 13 wherein the hypotube is configured such that the diameter is capable of temporarily and repeatedly increasing by between about 5-50% relative to a base diameter. 15. The catheter of any of examples 10-14 wherein the distal end portion includes a slot aligned with the gap, and wherein an end portion of the pull wire is operably coupled to the distal end portion within the slot.

16. A hypotube for use with a catheter, the hypotube comprising: an end portion; a first hemispherical segment extending from the end portion, the first hemispherical segment having a plurality of first ribs; and a second hemispherical segment extending from the end portion and parallel to the first hemispherical segment, the second hemispherical segment having a plurality of second ribs, wherein the first hemispherical segment and the second hemispherical segment (a) collectively define a lumen extending therethrough, and (b) are not directly coupled to each other along their respective lengths to define a longitudinal gap extending between the first hemispherical segment and the second hemispherical segment.

17. The hypotube of example 16 wherein the plurality of first ribs and the plurality of second ribs are at least partially deformable such that a diameter of the lumen is adjustable.

18. The hypotube of example 17 wherein a width of the longitudinal gap is configured to change in response to the diameter of the lumen being adjusted.

19. The hypotube of any of examples 16-18 wherein the hypotube is configured such that a diameter of the lumen is capable of temporarily and repeatedly increasing between about 5-50% relative to a base diameter.

20. The hypotube of any of examples 16-20 wherein the end portion includes a slot aligned with the longitudinal gap extending between the first and second hemispherical segments, and wherein the slot and the longitudinal gap are sized and shaped to receive a pull wire. Conclusion

[0045] 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 deliver medical devices that create a path of fluid communication between the left atrium and right atrium, the left ventricle and the right ventricle, or the left atrium and the coronary’ sinus, it should be appreciated that similar embodiments could be utilized for delivering shunts between other chambers of heart or in other regions of the body.

[0046] From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include the plural or singular term, respectively.

[0047] 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 any⁷ 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 ty pes 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 technology can encompass other embodiments not expressly shown or described herein.

Claims

CLAIMS I/'W e claim:

2. The catheter of claim 1 wherein the one or more gaps comprise (i) a first gap extending along a first side of the hypotube and (ii) a second gap extending along a second side of the hypotube opposite the first side, and wherein the one or more pull wires comprise (i) a first pull wire coupled to the first side of the distal end portion and extending through the first gap and (ii) a second pull wire coupled to the second side of the distal end portion and extending through the second gap.

3. The catheter of claim 1 wherein the one or more pull wires are welded to the distal end portion of the hypotube.

4. The catheter of claim 1 wherein the one or more pull wires are configured to remain within an outer diameter of the hypotube.

5. The catheter of claim 1 wherein each of the first region and the second region comprises a plurality of rib segments extending circumferentially around the lumen and towards the one or more gaps.

6. The catheter of claim 5 wherein adjacent ones of the rib segments define a plurality of grooves forming an overlapping spline pattern.

7. The catheter of claim 5 wherein a ratio between (i) a thickness of each rib segment along the longitudinal axis and (ii) a distance between adjacent ones of the rib segments along the longitudinal axis is between 1 : 1-1:2.

8. The catheter of claim 1 wherein, when the catheter is in the neutral state, a diameter of the lumen is between 0. 1-0.3 in.

9. The catheter of claim 1 wherein, when the catheter is in the neutral state, each of the one or more gaps has a width between 0.006-0.014 in.

10. A catheter, comprising: a hypotube having: a distal end portion, a first region extending from the distal end portion and having first ribs, and a second region extending from the distal end portion and having second ribs. wherein the first ribs and the second nbs collectively form a lumen extending through the hypotube, and wherein the first ribs are separated from the second ribs by a gap extending between the first region and the second region; a pull wire operably coupled to the distal end portion of the hypotube and extending through the gap between the first region and the second region, wherein the pull wire is configured to be manipulated to change an orientation of the catheter; and an outer membrane positioned around the hypotube and the pull wire.

11. The catheter of claim 10 wherein the first region is not directly coupled to the second region at any portion of the first and second regions having the first and second ribs.

12. The catheter of claim 10 wherein the first ribs extend about halfway around a circumference of the lumen, and wherein the second ribs extend about halfway around the circumference of the lumen.

13. The catheter of claim 10 wherein a diameter of the lumen is adjustable.

14. The catheter of claim 13 wherein the hypotube is configured such that the diameter is capable of temporarily and repeatedly increasing by between about 5-50% relative to a base diameter.

15. The catheter of claim 10 wherein the distal end portion includes a slot aligned with the gap, and wherein an end portion of the pull wire is operably coupled to the distal end portion within the slot.

16. A hypotube for use with a catheter, the hypotube comprising: an end portion; a first hemispherical segment extending from the end portion, the first hemispherical segment having a plurality of first ribs: and a second hemispherical segment extending from the end portion and parallel to the first hemispherical segment, the second hemispherical segment having a plurality of second ribs, wherein the first hemispherical segment and the second hemispherical segment (a) collectively define a lumen extending therethrough, and (b) are not directly coupled to each other along their respective lengths to define a longitudinal gap extending betw een the first hemispherical segment and the second hemispherical segment.

17. The hypotube of claim 1 wherein the plurality of first ribs and the plurality of second ribs are at least partially deformable such that a diameter of the lumen is adjustable.

18. The hypotube of claim 17 wherein a width of the longitudinal gap is configured to change in response to the diameter of the lumen being adjusted.

19. The hypotube of claim 16 wherein the hypotube is configured such that a diameter of the lumen is capable of temporarily and repeatedly increasing between about 5-50% relative to a base diameter.

20. The hypotube of claim 16 wherein the end portion includes a slot aligned with the longitudinal gap extending between the first and second hemispherical segments, and wherein the slot and the longitudinal gap are sized and shaped to receive a pull wire.