Delivery system with bistable capsule

Abstract

A delivery system includes an outer shaft defining an outer shaft lumen and a bistable capsule coupled to and extending distally from the outer shaft. The bistable capsule includes at least one bistable cell configured to transition from an axially expanded state and an axially compressed state. The bistable cell in the axially expanded state is configured to provide increased flexibility to the bistable capsule and the bistable cell in the axially compressed state is configured to provide enhanced column strength to the bistable capsule.

Description

DELIVERY SYSTEM WITH BISTABLE CAPSULECROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 593,675, filed October 27, 2023, the entire content of which is incorporated herein by reference.FIELD

[0002] The present disclosure relates to systems for percutaneous transcatheter delivery and implantation of a prosthesis, such as a stent, a stent-graft, or a valve prosthesis. More particularly, the present disclosure relates to delivery systems having a bistable capsule.BACKGROUND

[0003] Delivery catheters are commonly used to access vascular and other locations within a body and to deliver and deploy medical devices such as prosthetic heart valves, stent-grafts, and stents to selected targeted sites in the body. Such medical devices typically are releasably carried within a distal region of the delivery catheter in a radially compressed delivery state as the catheter is navigated to and positioned at a target treatment / deployment site. In many cases, such as those involving cardiovascular vessels, the route to the treatment / deployment site may be tortuous and may present conflicting design considerations requiring compromises between dimensions, flexibilities, material selection, and operational controls.

[0004] Delivery catheters for delivering prosthetic heart valve may include a capsule at a distal end of an outer shaft thereof for maintaining the prosthetic heart valve in the radially compressed delivery state. Upon retraction of the capsule, the prosthetic heart valve may radially expand to a radially expanded deployed state. In some procedures, it may be desirable to rotate the capsule with the prosthetic heart valve disposed therein to rotationally orient the prosthetic heart valve prior to deploying the prosthetic heart valve from the capsule. Such rotation or torque is often difficult to transfer from the handle of the delivery system to the capsule such that the capsule and the prosthetic heart valve disposed therein are rotated as desired.

[0005] Accordingly, there is a need for an improved capsule design to enable the capsule to be torqued / rotated.BRIEF SUMMARY

[0006] In accordance with an example hereof, in combination with any of the following examples, a delivery system includes a handle, an outer shaft extending distally from the handle, the outer shaft defining an outer lumen, and a bistable capsule coupled to and extending distally from the outer shaft, the bistable capsule including at least one bistable cell. The at least one bistable cell includes an axially expanded state and an axially compressed state, wherein the at least one bistable cell in the axially expanded state is configured to provide increased flexibility to the bistable capsule and the at least one bistable cell in the axially compressed state is configured to provide enhanced column strength to the bistable capsule.

[0007] In another example hereof, in the delivery system according to any of the preceding or following examples, the bistable capsule is configured to retain a prosthetic heart valve in a radially compressed configuration therein.

[0008] In another example hereof, in the delivery system according to any of the preceding or following examples, the at least one bistable cell comprises a plurality of bistable cells extending in a circumferential direction about a central longitudinal axis of the bistable capsule.

[0009] In another example hereof, in the delivery system according to any of the preceding or following examples, the plurality of bistable capsules form a circumferential ring.

[0010] In another example hereof, in the delivery system according to any of the preceding or following examples, the plurality of bistable cells extend in the circumferential direction about the central longitudinal axis of the bistable capsule at a plurality of axial locations of the bistable capsule.

[0011] In another example hereof, in the delivery system according to any of the preceding or following examples, the plurality of bistable capsules form a plurality of circumferential rings.

[0012] In another example hereof, in the delivery system according to any of the preceding or following examples, the at least one bistable cell comprises a plurality of bistable cells extending in an axial direction parallel to a central longitudinal axis of the bistable capsule.

[0013] In another example hereof, in the delivery system according to any of the preceding or following examples, wherein the plurality of bistable cells form a single axial spine.

[0014] In another example hereof, in the delivery system according to any of the preceding or following examples, the plurality of bistable cells form a plurality of axial spines.

[0015] In another example hereof, in the delivery system according to any of the preceding or following examples, the at least one bistable cell comprises struts arranged in a diamond pattern, with proximal struts having a larger cross-sectional area that distal struts.

[0016] In another example hereof, in the delivery system according to any of the preceding or following examples, the at least one bistable cell further comprises a proximal connector extending proximally from a proximal junction of the proximal struts and a distal connector extending distally from a distal junction of the distal struts.

[0017] In another example hereof, in the delivery system according to any of the preceding or following examples, the proximal struts comprise two proximal struts, each extending distally and circumferentially from the proximal junction and diverging from the proximal junction.

[0018] In another example hereof, in the delivery system according to any of the preceding or following examples, the distal struts comprise two distal struts, each extending proximally and circumferentially from the distal junction and diverging from the distal junction.BRIEF DESCRIPTION OF DRAWINGS

[0019] The foregoing and other features and advantages of the present disclosure will be apparent from the following description of embodiments hereof as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the presentdisclosure and to enable a person skilled in the pertinent art to make and use the embodiments of the present disclosure. The drawings may not be to scale.

[0020] FIG. 1 depicts a side view of an exemplary prosthetic heart valve.

[0021] FIG. 2 depicts an outflow view of the prosthetic heart valve of FIG. 1.

[0022] FIG. 3 depicts a schematic perspective view of a delivery system.

[0023] FIG. 4 depicts a side view of a bistable capsule of the delivery system of FIG. 3 according to embodiments hereof.

[0024] FIG. 5 depicts an illustration of a bistable cell in an expanded state, according to embodiments hereof.

[0025] FIG. 6 depicts an illustration of the bistable cell of FIG. 6 in a compressed state, according to embodiments hereof.

[0026] FIG. 7 depicts a bistable capsule of the delivery system of FIG. 3 with the plurality of bistable cells axially oriented, according to embodiments hereof.DETAILED DESCRIPTION

[0027] It should be understood that various embodiments disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to conduct the techniques). In addition, while certain aspects of this disclosure are described as being performed by a single device or component for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of devices or components associated with, for example, a delivery device. The following detailed description is merely exemplary in nature and is not intended to limit the disclosure of the application and uses of the disclosure. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding field of the invention, background, summary, or the following detailed description.

[0028] As used in this specification, the singular forms “a”, “an” and “the” specifically also encompass the plural forms of the terms to which they refer, unless the content clearlydictates otherwise. Further, numerical terms such as “first”, “second”, “third”, etc. used herein are not meant to be limiting such that use of the term “second” when referring to a part in the specification does not mean that there necessarily is a “first” part in order to fall within the scope of the disclosure. Instead, such numbers are merely describing that the particular embodiment being described has a “first” part and a “second” part. The disclosure is instead defined by the claims, in which one or more of the numbered parts may be claimed.

[0029] The terms “distal” and “proximal” when used in the following description to refer to a delivery system or catheter are with respect to a position or direction relative to the treating clinician or the handle. Thus, “distal” and “distally” refer to positioned distant from, or in a direction away from the treating clinician or handle, and the terms “proximal” and “proximally” refer to positions near, or in a direction toward the clinician or handle.

[0030] Embodiments hereof relate to bistable capsules of delivery systems, wherein the bistable capsule has a frame including at least one bistable cell. A “bistable cell” is a cell that can switch between two stable positions or states depending upon the input force / energy. The at least one bistable cell of the frame provides the bistable capsule with an adjustable shape and variable stiffness depending upon the loading conditions on the at least one bistable cell. Each bistable cell may be formed from a plurality of struts, and may include a variable resistance to compression depending on the thickness of the plurality of struts of the bistable cell. The bistable capsule is configured for use with a delivery system for delivering a prosthetic heart valve. Each bistable cell includes an expanded state wherein the bistable cell remains flexible, and a compressed state wherein the bistable cell has an enhanced column strength to prevent buckling. Each bistable cell is configured to prevent the bistable capsule from whipping when the capsule is rotated, bent, torqued, or compressed. A plurality of bistable cells can be grouped into circular rings at various points along the length of the bistable capsule to function as a flexible hinge at critical bend points for tracking, delivery, and deployment of the prosthetic heart valve to a desired treatment site within a vasculature of a patient. A plurality of bistable cells may be axially oriented to prevent buckling under the compressive loads when recapturing a prosthetic heart valve.

[0031] FIGS. 1 and 2 illustrate an exemplary prosthetic heart valve 100. The delivery systems described herein may be used with the prosthetic heart valve 100 and / or other prosthetic heart valves. The prosthetic heart valve 100 is illustrated herein in order tofacilitate description of the present disclosure. The following description of the prosthetic heart valve 100 is merely exemplary in nature and is not intended to limit the disclosure or the application and uses of the disclosure.

[0032] FIGS. 1 and 2 illustrate a side view and an outflow view, respectively, of the prosthetic heart valve 100. The prosthetic heart valve 100 includes a radially expandable frame or stent 102 and a prosthetic valve 104. The frame 102 of the prosthetic heart valve 100 supports the prosthetic valve 104 within the interior of the frame 102. In the example prosthetic heart valve 100 shown in FIGS. 1 and 2, the frame 102 may be self-expandable. However, this is not meant to be limiting, and the frame 102 can be balloon-expandable or mechanically expandable.

[0033] The prosthetic valve 104 includes at least one valve leaflet 106 disposed within and secured to the frame 102, as best viewed in FIG. 2. In the embodiment shown in FIGS. 1-2, the prosthetic valve 104 includes exactly three valve leaflets 106, as shown in FIG. 2. However, this is not meant to be limiting, as the prosthetic valve 104 may include more or fewer valve leaflets 106. The valve leaflets 106 open and close to regulate flow through the prosthetic heart valve 100.

[0034] As shown in FIG. 1, the prosthetic heart valve 100 includes an inflow end 108 and an outflow end 110. The valve leaflets 106 are attached to the frame 102 such that when pressure at the inflow end 108 exceeds pressure at the outflow end 110, the valve leaflets 106 open to allow blood flow through the prosthetic heart valve from the inflow end 108 to the outflow end 110. When the pressure at the outflow end 110 exceeds pressure at the inflow end 108, the valve leaflets 106 close to prevent blood flow from the outflow end 110 to the inflow end 108.

[0035] The frame 102 of the prosthetic heart valve 100 includes a plurality of struts 112 that are arranged to form a plurality of side openings 114 arranged circumferentially around a longitudinal axis LA of the prosthetic heart valve 100 and longitudinally to form a tubular structure defining a central lumen 116 of the prosthetic heart valve 100. The struts 112 are defined herein as the elongated wire segments of the frame 102. The plurality of struts 112 come together to form crowns 118 or nodes 120, as can be seen in FIG. 1. The frame 102 is configured to secure the prosthetic valve 104 within the central lumen 116 of the frame 102 and to secure the prosthetic heart valve 100 in place in the vasculature of the patient.

[0036] FIG. 3 shows a side view of a delivery system 300 for delivering and deploying a prosthetic heart valve according to embodiments hereof. One skilled in the art will realize that FIG. 3 illustrates one example of a delivery system and that components illustrated in FIG. 3 may be removed and / or additional components may be added. The delivery system 300 is merely an example, and the graft covers or capsules described herein may be used with other delivery systems.

[0037] The delivery system 300 includes a distal end 302, a proximal end 304, a handle 306, an outer shaft 308, a bistable capsule 310, and an inner shaft 312. The outer shaft 308 includes an outer lumen 314 extending therethrough. A proximal end 316 of the bistable capsule 310 may be coupled to a distal end 318 of the outer shaft 308. The bistable capsule 310 is configured to surround a prosthetic heart valve, such as the prosthetic heart valve 100 of FIGS. 1-2, during delivery to the treatment site, e.g., a native heart valve. The bistable capsule 310 may be retracted from the prosthetic heart valve 100 to expose the prosthetic heart valve 100, thereby enabling the prosthetic heart valve 100 to self-expand. The inner shaft 312 extends from the handle 306 and is slidably disposed through the outer lumen 314 of the outer shaft 308. A distal tip 320 may be coupled to a distal end of the inner shaft 312. The inner shaft 312 may be coupled to the handle 306 such that movement of the handle 306 translates to movement of the inner shaft 312 and the distal tip 320. In an embodiment, the inner shaft 312 may be a tubular component defining a central lumen configured to slidably receive a guidewire (not shown) therethrough.

[0038] The handle 306 enables a clinician to manipulate a distal portion of the delivery system 300 and includes one or more actuators for moving parts of the delivery system 300 relative to other parts of the delivery system. In the delivery system 300, the outer shaft 308 may be coupled to an actuator 322 of the handle 306 for moving the outer shaft 308 and the bistable capsule 310 relative to the inner shaft 312. When the delivery system 300 is in a position such that the prosthetic heart valve 100 is in the desired deployment position in a patient’s vasculature, the actuator 322 may be actuated to proximally retract the outer shaft 308 and bistable capsule 310 relative to the inner shaft 312 and the prosthetic heart valve 100, thereby releasing or unsheathing the prosthetic heart valve 100 to self-expand and deploy at the treatment site.

[0039] As explained above, the bistable capsule 310 of the delivery system 300 is configured to retain the prosthetic heart valve 100 therein for delivery and deployment of the prosthetic heart valve 100 to a desired treatment site. FIGS. 4-6 show the bistable capsule 310 including at least one bistable cell 324, according to embodiments hereof. FIG. 4 illustrates the bistable capsule 310 with a plurality of bistable cells 324 oriented in a plurality of circumferential rings 326. FIGS. 5-6 depict close-up views of the bistable cell 324 in an axially expanded state and an axially compressed state, respectively. FIG. 7 illustrates an embodiment wherein a plurality of bistable cells 324 is oriented in an axial or longitudinal run.

[0040] In the embodiment shown in FIG. 4, the bistable capsule 310 includes the plurality of bistable cells 324, as will be described in more detail below. The bistable capsule 310 may be a tubular structure having a distal end 328, the proximal end 316, and a lumen 330 extending from the distal end 328 to the proximal end 316. The lumen 330 of the bistable capsule 310 may be sized and shaped to contain the prosthetic heart valve 100 in the radially compressed state therein. An intermediate region 332 of the bistable capsule 310 includes a plurality of slots 334 and a plurality of ribs 336. Each slot 334 may be separated or demarcated by the plurality of ribs 336, such that generally each rib 336 may be separated from an adjacent rib 336 by a slot 334. The plurality of ribs 336 and the plurality of slots 334 may be formed via laser-cutting the tubular bistable capsule 310 and are configured to impart non-kinking flexibility to the bistable capsule 310. In embodiments hereof, the bistable capsule 310 may be steered by methods such as, but not limited to a pull wire as described in greater detail in U.S. Patent Pub. 2021 / 0033259A1 to Crosbie et al., which is assigned to the same assignee as the present application and herein incorporated by reference in its entirety.

[0041] In the embodiments of FIG. 4, the intermediate region 332 of the bistable capsule310 includes the plurality of bistable cells 324 oriented in a circumferential direction about a central longitudinal axis CLA of the bistable capsule 310 forming a circumferential ring 326. The bistable cells 324 may be formed with by laser-cutting the bistable cell pattern while laser-cutting the pattern of the remainder of the capsule 310. In other embodiments, the bistable cells 324 may be formed separately and coupled to the remainder of the bistable capsule 310 (e.g., the ribs 336 and slots 334), such as by plasma or laser welding. Eachcircumferential ring 326 is configured to provide increased flexibility to the bistable capsule 310 during tracking, positioning, and deployment and to provide enhanced column strength during recapture of a prosthetic heart valve, as described below. Arranging the bistable cells 324 circumferentially as shown in FIG. 4 provides increased flexibility (i.e., for bending) at critical bending points, while maintaining column strength when transitioned to a secondary compressed state (FIG. 6) such as for recapture. Those skilled in the art will recognize that the particular locations, sizes, and quantity of circumferential rings 326 and of the bistable cells 324 are an example, and are not meant to be limiting.

[0042] An example bistable cell 324 is shown in FIGS. 5 and 6. In particular, in the embodiment shown, each bistable cell 324 includes two (2) first struts 340A and 340B, two (2) second struts 342A and 342B, a first connector 344, and a second connector 346. Each first strut 340A, 340B includes a first end 348A, 348B, respectively, and a second end 350A, 350B, respectively. Each second strut 342A, 342B includes a first end 352A, 352B, respectively, and a second end 354A, 354B, respectively.

[0043] A proximal junction or crown 356 is formed at the point of convergence of the first ends 348A, 348B of the first struts 340A, 340B, and the first connector 344 extends proximally therefrom. A distal junction or crown 358 is formed at the point of convergence of the second ends 354A, 354B of the opposing second struts 342A, 342B, and the second connector 346 extends distally therefrom. Two junctions or crowns 360A, 360B are formed at the points of convergence of the second ends 350A, 350B of the first struts 340A, 340B and the first ends 352A, 352B of the second struts 342A, 342B, respectively. Thus, the two first struts 340A, 340B and the two second struts 342A, 342B form a diamond shape, as shown in FIG. 5. Further, each bistable cell 324 forms an opening 362 defined by the edges of the plurality of the first struts 340A, 340B and the edges of the plurality of second struts 340A, 340B. When the bistable cell 324 is in an expanded state, as shown in FIG. 6, the opening 362 may be substantially diamond shaped.

[0044] Each first strut 340A, 340B is configured to be substantially rigid such that each first strut 340A, 340B are configured not to deform under compression associated with recapture. In embodiments hereof, each second strut 342A, 342B may be of a smaller crosssection than each of the first struts 340A, 340B. Each of the second struts 342A, 342B is configured to flex under tension and compression. Thus, when a threshold compressiveforce has been reached, such as during recapture, the second struts 342A, 342B will flex, as shown in FIG. 6 and described below, to provide increased axial strength during recapture. In an embodiment, each of the first struts 340A, 340B has a thickness in the range of about 1.0 mm to about 3.5 mm. In an embodiment, each of the second struts 342A, 342B has a thickness in the range of about 0.2 mm to about 1.0 mm, Accordingly, the flexibility (or deformation under load) of each bistable cell 324 depends on the cross-sectional area of the second struts 342A, 342B. By varying the positions and cross-sections of the second struts 342A, 342B of the plurality of bistable cells 324 within the bistable capsule 310, the bistable capsule 310 can be configured to have variable stiffness along the axial or longitudinal length of the bistable capsule 310. The plurality of bistable cells 324 may be grouped in circumferential rings 326 as shown in FIG. 4. Each circumferential ring 326 may be disposed at various axial positions along the bistable capsule 310. More precisely, the plurality of bistable cells 324 may be grouped in circumferential rings 326 and disposed at positions along the axial length of the bistable capsule 310, wherein each circumferential ring 326 acts as a flexible hinge at a critical bend point of the bistable capsule 310. Each circumferential ring 326 is configured to provide increased flexibility to the bistable capsule 310 during tracking, positioning, and deployment. The increased flexibility of the plurality of bistable cells 324 may prevent whipping of the bistable capsule 310 under various torque conditions.

[0045] Each bistable cell 324 may be formed of materials, for example, and not by way of limitation, of nickel titanium alloy (nitinol), stainless steel, or other materials suitable for the purposes described herein. In an embodiment, the bistable cells 324 may be formed by laser-cutting or etching the bistable cell pattern with laser-cut or etched pattern of the remainder of the capsule 310. In other embodiments, the bistable cells may be formed separately and coupled to the remainder of the capsule 310, such as by laser or plasma welding.

[0046] In embodiments herein, the second connector 346 includes a first portion 364 and a second portion 366, as shown in FIG. 5. In an embodiment, the first portion 364 has a smaller cross-section than the second portion 366. The first portion 364 may have a smaller cross-section to provide space to enable the second struts 342A, 342B to flex, as shown in FIG. 6.

[0047] The operation of the plurality of bistable cells 324 will now be described with reference to FIGS. 5-6. FIG. 5 illustrates the bistable cell 324 in an axially expanded state. In the axially expanded state, the bistable cell 324 remains flexible for loading, tracking, positioning, and deployment. The bistable cell 324 in the axially expanded state is configured to absorb or minimize applied rotational force or torque to thereby resist bending plane bias and prevent whipping of the bistable capsule 310. FIG. 6 shows the bistable cell 324 in an axially compressed state, wherein the second struts 342A, 342B have each deformed during a compressive load, for example during recapture of the prosthetic heart valve 100. As can be seen in FIG. 6, in the axially compressed state, the second struts 342A, 342B have deformed due to a compressive force in the direction of the arrow 600, thereby also causing the second connector 346 to move axially in the direction of the arrow 600. In the axially compressed state, the bistable cell 324 has enhanced column strength to prevent buckling under compressive load such as during recapture of a partially deployed prosthetic heart valve.

[0048] While the embodiment of FIG. 4 illustrates a bistable capsule 310 with a specific number of circumferential rings 326 disposed at specific locations along the length of the bistable capsule 310, this is not meant to limit the design, and more or fewer circumferential rings 326 may be used. Moreover, each circumferential ring 326 may be disposed at various locations along the length of the bistable capsule 310 in embodiments hereof. In various embodiments, the bistable capsule may have exactly one, two, three, or more circumferential rings 326.

[0049] FIG. 7 illustrates a bistable capsule 710 according to embodiments hereof. The bistable capsule 710 is similar to the bistable capsule 310 in that the bistable capsule 710 includes a distal end 728, a proximal end 716, and a lumen 730 extending from the distal end 728 to the proximal end 716. The lumen 730 of the bistable capsule 710 may be sized and shaped to contain the prosthetic heart valve 100 in the radially compressed state therein. An intermediate region 732 of the bistable capsule 710 includes a plurality of slots 734 and a plurality of ribs 736, as described above. The bistable capsule 710 includes a plurality of bistable cells 724 arranged or oriented in an axial direction, or parallel to a central longitudinal axis CLA of the bistable capsule 710, to form an axial run or spine 770. The axial spine 770 may be configured to deflect the bistable capsule 710 in a preferred directionupon the application of force thereon. In greater detail, when the bistable capsule 710 is manipulated, for example while tracking the bistable capsule 710 through the vasculature of a patient, axial, lateral, and rotational forces may be applied to the bistable capsule 710. The greater flexibility of the plurality of bistable cells 724 in the axial spine 770 preferentially deflects or bends the bistable capsule 810 in the direction of the axial run 770. The preferred deflection may facilitate steering and tracking of the bistable capsule 710 through tortuous vasculature and improve delivery accuracy at the treatment site.

[0050] FIG. 7 illustrates the bistable capsule 710 with the plurality of bistable cells 724 oriented in a single axial spine 770. However, this is not meant to limit the design and the plurality of bistable cells 724 can be oriented in more than one axial spine 770 at more than one location of the bistable capsule 710. In embodiments where there are more than one axial spine 770, the spines 770 may be evenly spaced circumferentially (e.g., for two spines 770, they may be 180 degrees apart). While the plurality of bistable cells 724 of the axial spine 770 is illustrated in FIG. 7 extending generally the length of the bistable capsule 710, this, too, is not meant to be limiting, and each axial spine 770 may be only along a portion of the length of the bistable capsule 710.

[0051] It should be understood that various embodiments disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. In addition, while certain aspects of this disclosure are described as being performed by a single device or component for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of devices or components.

[0052] The following examples are illustrative of the techniques described herein.

[0053] Example 1. A delivery system comprising: a handle; an outer shaft extending distally from the handle, the outer shaft defining an outer lumen; and a bistable capsule coupled to and extending distally from the outer shaft, the bistable capsule including at least one bistable cell; wherein the at least one bistable cell includes an axially expanded state and an axially compressed state, wherein the at least one bistable cell in the axially expanded state is configured to provide increased flexibility to the bistable capsule and the at least one bistable cell in the axially compressed state is configured to provide enhanced column strength to the bistable capsule.

[0054] Example 2. The delivery system of Example 1, wherein the bistable capsule is configured to retain a prosthetic heart valve in a radially compressed configuration therein.

[0055] Example 3. The delivery system of claim 1, wherein the at least one bistable cell comprises a plurality of bistable cells extending in a circumferential direction about a central longitudinal axis of the bistable capsule.

[0056] Example 4. The delivery system of Example 3, wherein the plurality of bistable capsules form a circumferential ring.

[0057] Example 5. The delivery system of Example 3, wherein the plurality of bistable cells extend in the circumferential direction about the central longitudinal axis of the bistable capsule at a plurality of axial locations of the bistable capsule.

[0058] Example 6. The delivery system of Example 5, wherein the plurality of bistable capsules form a plurality of circumferential rings.

[0059] Example 7. The delivery system of Example 1, wherein the at least one bistable cell comprises a plurality of bistable cells extending in an axial direction parallel to a central longitudinal axis of the bistable capsule.

[0060] Example 8. The delivery system of Example 7, wherein the plurality of bistable cells form a single axial spine.

[0061] Example 9. The delivery system of Example 8, wherein the plurality of bistable cells form a plurality of axial spines.

[0062] Example 10. The delivery system of Example 1, wherein the at least one bistable cell comprises struts arranged in a diamond pattern, with proximal struts having a larger cross- sectional area that distal struts.

[0063] Example 11. The delivery system of Example 10, wherein the at least one bistable cell further comprises a proximal connector extending proximally from a proximal junction of the proximal struts and a distal connector extending distally from a distal junction of the distal struts.

[0064] Example 12. The delivery system of Example 11, wherein the proximal struts comprise two proximal struts, each extending distally and circumferentially from the proximal junction and diverging from the proximal junction.

[0065] Example 13. The delivery system of Example 12, wherein the distal struts comprise two distal struts, each extending proximally and circumferentially from the distal junction and diverging from the distal junction.

Claims

CLAIMSWhat is claimed is:

1. A delivery system comprising: a handle (306); an outer shaft (308) extending distally from the handle, the outer shaft defining an outer lumen (314); and a capsule (310, 710) coupled to and extending distally from the outer shaft characterized in that: the capsule is a bistable capsule (310, 710) including at least one bistable cell (324, 724); the at least one bistable cell includes an axially expanded state and an axially compressed state, and the at least one bistable cell in the axially expanded state is configured to provide increased flexibility to the bistable capsule and the at least one bistable cell in the axially compressed state is configured to provide enhanced column strength to the bistable capsule.

2. The delivery system of claim 1, wherein the bistable capsule (310, 710) is configured to retain a prosthetic heart valve (100) in a radially compressed configuration therein.

3. The delivery system of claim 1 or claim 2, wherein the at least one bistable cell (324) comprises a plurality of bistable cells extending in a circumferential direction about a central longitudinal axis (CLA) of the bistable capsule.

4. The delivery system of claim 3, wherein the plurality of bistable cells form a circumferential ring (326).

5. The delivery system of claim 3, wherein the plurality of bistable cells (324) extend in the circumferential direction about the central longitudinal axis of the bistable capsule at a plurality of axial locations of the bistable capsule.

6. The delivery system of claim 5, wherein the plurality of bistable capsules form a plurality of circumferential rings (326).

7. The delivery system of claim 1 or claim 2, wherein the at least one bistable cell comprises a plurality of bistable cells (724) extending in an axial direction parallel to a central longitudinal axis (CLA) of the bistable capsule.

8. The delivery system of claim 7, wherein the plurality of bistable cells form a single axial spine (770).

9. The delivery system of claim 8, wherein the plurality of bistable cells form a plurality of axial spines (770).

10. The delivery system of claim 1, wherein the at least one bistable cell comprises struts (340A, 340B, 342A. 342B) arranged in a diamond pattern, with proximal struts (340A, 340B) of the struts having a larger cross-sectional area than distal struts (342A, 342B) of the struts.

11. The delivery system of claim 10, wherein the at least one bistable cell further comprises a proximal connector (344) extending proximally from a proximal junction (356) of the proximal struts and a distal connector (346) extending distally from a distal junction (358) of the distal struts.

12. The delivery system of claim 11, wherein the proximal struts (340A, 340B) comprise two proximal struts, each extending distally and circumferentially from the proximal junction (356) and diverging from the proximal junction.

13. The delivery system of claim 12, wherein the distal struts (342A, 342B) comprise two distal struts, each extending proximally and circumferentially from the distal junction (358) and diverging from the distal junction.

Images