Connections between heart valve prostheses and delivery systems

Abstract

A delivery system for delivering a heart valve prosthesis includes a delivery catheter and a heart valve prosthesis. The delivery catheter includes a retainer comprising a pocket. The heart valve prosthesis includes a frame and a connector extending from an end of the frame. The connector is disposed in the pocket of the retainer to couple the heart valve prosthesis to the delivery catheter. The pocket and the connector are configured to prevent hang-up of the connector in the pocket such as to improve release of the connector from the pocket of the retainer.

Description

CONNECTIONS BETWEEN HEART VALVE PROSTHESES AND DELIVERYSYSTEMSCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 675,758, filed July 26, 2024, the entire content of which is incorporated herein by reference.FIELD

[0002] The present disclosure is related to connections between heart valve protheses and delivery systems for delivering and deploying heart valve prostheses.BACKGROUND

[0003] Patients suffering from various medical conditions or diseases may require surgery to install an implantable medical device. For example, valve regurgitation or stenotic calcification of leaflets of a heart valve may be treated with a heart valve replacement procedure. A traditional surgical valve replacement procedure requires a sternotomy and a cardiopulmonary bypass, which creates significant patient trauma and discomfort. Traditional surgical valve procedures may also require extensive recuperation times and may result in life-threatening complications.

[0004] One alternative to a traditional surgical valve replacement procedure is delivering implantable medical devices using minimally invasive techniques. For example, a heart valve prosthesis can be percutaneously and transluminally delivered and deployed at the site of the diseased heart valve through catheter-based delivery systems. Such heart valve prostheses can be delivered while in a low-profile or compressed configuration so that the heart valve prosthesis can be advanced through the patient’s vasculature. Once positioned at the treatment location, the heart valve prosthesis can be expanded to engage tissue at the diseased heart valve region to, for instance, hold the heart valve prosthesis in position.

[0005] Manipulation of the delivery system during delivery and deployment may impart twisting or rotational forces on various components of the delivery system. Due to thedifferent torque transfer rates of the various components of the delivery system, the twisting or rotational forces may impede normal deployment of the heart valve prosthesis. More precisely, the twisting forces between a retainer of the delivery system and the frame of the heart valve prosthesis may cause a connector of the heart valve prosthesis to hang up on the retainer of the delivery system during deployment. The present disclosure relates to improvements relating to connections between such delivery systems and heart valve prosthesis, and more specifically to improved delivery catheter retainers and improved heart valve prosthesis connectors.SUMMARY

[0006] In an example hereof, a retainer for a delivery catheter for delivering a heart valve prosthesis comprises: a generally tubular body comprising a body portion including a body portion outer surface and a lumen extending through the body portion; and a pocket, wherein the pocket includes a pocket outer surface that is depressed with respect to the body portion outer surface towards a central longitudinal axis of the retainer. The pocket is defined by: a first side wall extending generally longitudinally; a second side wall extending generally longitudinally on an opposite side of a centerline of the pocket; a proximal wall extending from the first side wall to the second side wall; and a distal wall extending generally circumferentially from the second side wall towards the centerline. There is no corresponding distal wall extending from the first side wall towards the centerline.

[0007] In another example hereof, in the retainer of any of the preceding or following examples, the pocket further comprises a distal opening between defined between the distal wall and a distal end of the first side wall.

[0008] In another example hereof, in the retainer of any of the preceding or following examples, the first side wall is spaced a first circumferential distance from the centerline and the second side wall is spaced a second circumferential distance from the centerline, wherein the first circumferential distance and the second circumferential distance are about equal.

[0009] In another example hereof, in the retainer of any of the preceding or following examples, the distal opening is asymmetric in that a first distance from the centerline the distal wall is shorter than a second distance from the centerline to the first wall.

[0010] In another example hereof, in the retainer of any of the preceding or following examples, the proximal wall is curved, and wherein an apex of the proximal wall is aligned with the centerline.

[0011] In another example hereof, in the retainer of any of the preceding or following examples, the pocket is generally a half-paddle shape.

[0012] In another example hereof, in the retainer of any of the preceding or following examples, the centerline of the pocket is a centerline of a distal opening of the pocket, wherein the pocket is asymmetric with respect to the centerline.

[0013] In another example hereof, in the retainer of any of the preceding or following examples, the first side wall is spaced a first circumferential distance from the centerline and the second side wall is spaced a second circumferential distance from the centerline, wherein the first circumferential distance is shorter than the second circumferential distance.

[0014] In another example hereof, in the retainer of any of the preceding or following examples, the distal opening is symmetric with respect to the centerline in that a first distance from the centerline the distal wall is about equal to a second distance from the centerline to the first side wall.

[0015] In another example hereof, a retainer for a delivery catheter for delivering a heart valve prosthesis comprises: a generally tubular body comprising a body portion including a body portion outer surface and a lumen extending through the body portion; and a pocket, wherein the pocket includes a pocket outer surface that is depressed with respect to the body portion outer surface towards a central longitudinal axis of the retainer, wherein the pocket is generally diamond-shaped.

[0016] In another example hereof, in the retainer of any of the preceding or following examples, the pocket is defined by: a first side wall extending proximally and away from a centerline of the pocket on a first side of the centerline at a first angle relative to the centerline; a second side wall extending proximally from a proximal end of the first side wall and towards the centerline at a second angle relative to the centerline to an apex; a third side wall extending distally from the apex and away from the centerline on a second side of the centerline at a third angle; and a fourth side wall extending distally from a distal end of the third side wall and towards the centerline at a fourth angle.

[0017] In another example hereof, in the retainer of any of the preceding or following examples, the first angle, the second angle, the third angle, and the fourth angle are about equal.

[0018] In another example hereof, in the retainer of any of the preceding or following examples, each of the first angle, the second angle, the third angle, and the fourth angle is in a range of about 15° to about 75° or about 30° to about 60°.

[0019] In another example hereof, a heart valve prosthesis comprises: a frame having a first end, a second end, and a central lumen extending between the first end and the second end, the frame comprising a plurality of struts defining cells; a valve component disposed within and coupled to the frame; and a connector extending from the first end of the frame, the connector configured to couple the frame to a delivery system, the connector including a paddle, wherein the paddle is configured to release from the delivery system with minimal hang-up.

[0020] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the connector further includes a stem coupling the paddle to the frame.

[0021] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the paddle is asymmetric with respect a centerline of the stem.

[0022] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the connector is half-paddle shaped.

[0023] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the paddle comprises a first edge extending generally longitudinally in a first direction on a first side of the centerline, a second edge extending from the first edge generally circumferentially from the first side of the centerline to a second side of the centerline, a third edge extending from the second edge generally longitudinally in a second direction opposite the first direction, and a fourth edge extending from the third edge towards the centerline.

[0024] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the first edge is spaced a first circumferential distance from the centerline and the third edge is spaced a second circumferential distance from the centerline, wherein the second circumferential distance is larger than the first circumferential distance.

[0025] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the first edge comprises a longitudinal continuation of a first stem edge of the stem on the first side of the centerline and the third edge is spaced circumferentially from a second stem edge on the second side of the centerline by the fourth edge.

[0026] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the paddle is generally diamond-shaped.

[0027] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the paddle comprises a first edge that is chamfered.

[0028] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the paddle comprises a first edge extending longitudinally and at a first angle away from the centerline in a first direction on a first side of the centerline, a second edge extending from the first edge generally circumferentially from the first side of the centerline to a second side of the centerline, a third edge extending from the second edge generally longitudinally in a second direction opposite the first direction, and a fourth edge extending from the third edge towards the centerline.

[0029] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the first angle is in a range of about 15° to about 75° or about 30° to about 60°.

[0030] In another example hereof, a delivery system for delivering a heart valve prosthesis to a desired treatment location comprises: a delivery catheter including an inner shaft, an outer shaft, a middle member disposed radially between the inner shaft and the outer shaft, and a retainer coupled to a distal portion of the middle member, the retainer comprising a pocket; and a heart valve prosthesis including a frame, a valve component disposed within and coupled to the frame, and a connector extending from an end of the frame. In a delivery configuration the connector of the frame is disposed in the pocket of the retainer to couple the heart valve prosthesis to the delivery catheter. The pocket and the connector are configured to prevent hang-up of the connector in the pocket such as to improve release of the connector from the pocket of the retainer.

[0031] In another example hereof, in the delivery system of any of the preceding or following examples, the retainer comprises the retainer of any one of preceding examples.

[0032] In another example hereof, in the delivery of any of the preceding examples, the connector comprises the connector of the heart valve prosthesis of any one of preceding examples.

[0033] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0034] 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 present disclosure 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.

[0035] FIG. 1 depicts a side view illustration of a delivery system according to embodiments hereof.

[0036] FIG. 2 depicts a cross-sectional view taken along line A-A of FIG. 1.

[0037] FIG. 3 depicts a perspective view of a distal portion of the delivery system of FIG.1.

[0038] FIG. 4 depicts a side view illustration of a prior art retainer.

[0039] FIG. 5 depicts a side view illustration of a prior art heart valve prostheses.

[0040] FIG. 6 depicts an end view illustration of the heart valve prosthesis of FIG. 5.

[0041] FIG. 7 depicts a side view illustration of the connector of the heart valve prosthesis of FIG. 5.

[0042] FIG. 8 depicts a side view illustration of a connector of a heart valve prothesis according to embodiments hereof.

[0043] FIG. 9 depicts a side view illustration of the heart valve prosthesis including the connector of FIG. 8 according to embodiments hereof.

[0044] FIG. 10 depicts a side view illustration of the connector of FIG. 8 disposed on a retainer of a delivery system.

[0045] FIG. 11 depicts a side view illustration of the connector of FIG. 8 twisted in a pocket of a retainer.

[0046] FIG. 12 depicts another a side view illustration of the connector of FIG. 8 twisted in a pocket of a retainer.

[0047] FIG. 13 depicts a side view illustration of a retainer according to embodiments hereof.

[0048] FIG. 14 depicts a side view illustration of a connector of a heart valve prosthesis disposed on the retainer of FIG. 13.

[0049] FIG. 15 depicts a side view illustration of a connector twisted in a pocket of the retainer of FIG. 13.

[0050] FIG. 16 depicts another side view illustration of a connector twisted in a pocket of the retainer of FIG. 13.

[0051] FIG. 17 depicts a side view illustration of a retainer according to embodiments hereof.

[0052] FIG. 18 depicts a side view illustration of a connector of a heart valve prosthesis disposed on the retainer of FIG. 17.

[0053] FIG. 19 depicts a side view illustration of the connector of FIG. 17 twisted in the pocket of the retainer of FIG. 17.

[0054] FIG. 20 depicts another side view illustration of the connector of FIG. 17 twisted in the pocket of the retainer of FIG. 17.

[0055] FIG. 21 depicts a side view illustration of a connector of a heart valve prosthesis according to embodiments hereof.

[0056] FIG. 22 depicts a side view illustration of the connector of a heart valve prosthesis of FIG. 21 disposed on a retainer.

[0057] FIG. 23 depicts a side view illustration of the connector of FIG. 21 twisted in a pocket of a retainer.

[0058] FIG. 24 depicts a side view illustration of the connector of FIG. 21 twisted in a pocket of a retainer.

[0059] FIG. 25 depicts a side view illustration of a retainer according to embodiments hereof.

[0060] FIG. 26 depicts a side view illustration of a connector of a heart valve prosthesis according to embodiments hereof.

[0061] FIG. 27 depicts a side view illustration of the connector of a heart valve prosthesis of FIG. 26 disposed on the retainer of FIG. 25.

[0062] FIG. 28 depicts a side view illustration of the connector of FIG. 26 twisted in the pocket of the retainer of FIG. 25.

[0063] FIG. 29 depicts another side view illustration of the connector of FIG. 26 twisted in the pocket of the retainer of FIG. 25.

[0064] FIG. 30 depicts a perspective view illustration of a retainer according to embodiments hereof.

[0065] FIG. 31 depicts a perspective view illustration of a connector of a heart valve prosthesis according to embodiments hereof.

[0066] FIG. 32 depicts a cross-section of the connector taken at line A-A of FIG. 31 .

[0067] FIG. 33 depicts the connector of the heart valve prosthesis of FIG. 31 disposed on the retainer of FIG. 30.

[0068] FIG. 34 depicts a side view illustration of the connector of FIG. 31 twisted in the pocket of the retainer of FIG. 30.

[0069] FIG. 35 depicts another side view illustration of the connector of FIG. 31 twisted in the pocket of the retainer of FIG. 30.DETAILED DESCRIPTION

[0070] 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 carry out 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 system. The following detailed description is merely exemplary in nature and is not intended to limit the disclosure and embodiments hereof. Furthermore,there is no intention to be bound by any expressed or implied theory presented in the preceding field, background, summary, or the following detailed description.

[0071] 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 clearly dictates 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. The term “about” is used herein to mean approximately, in the region of, roughly, or around. When the term “about” is used in conjunction with a numerical range, it modifies that range by extending the boundaries above and below the numerical values set forth. In general, the term “about” is used herein to modify a numerical value above and below the stated value. It should be understood that use of the term “about” also includes the specifically recited numerical value.

[0072] 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 of the delivery system. Thus, “distal” and “distally” refer to positioned distant from, or in a direction away from the treating clinician or the handle of the delivery system, and the terms “proximal” and “proximally” refer to positions near, or in a direction toward the clinician or the handle of the system. The terms “proximal” and “distal” when used herein with respect to an implanted heart valve prosthesis device are used with reference to the direction of blood flow. Therefore, “proximal” and “proximally” mean upstream with respect to the direction of blood flow, and “distal” and “distally” mean downstream with respect to the direct of blood flow.

[0073] In addition, the term “self-expanding” is used in the following description with reference to one or more stent structures of the prostheses hereof is intended to convey that the structures are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded or deployed configuration. Non-exhaustive illustrative self-expandingmaterials include stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or nitinol, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal. Mechanical memory may be imparted to a wire or stent structure by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol.

[0074] The following detailed description is merely illustrative in nature and is not intended to limit the invention or the application and uses of the invention. Although the description of embodiments hereof are in the context of delivery systems for delivering a heart valve prosthesis within a native aortic valve, the delivery systems of the invention can also be used in other areas of the body, such as for delivering a heart valve prosthesis within a native mitral valve, for delivering a heart valve prosthesis within a native pulmonic valve, for delivering a heart valve prosthesis within a native tricuspid valve, for delivering a venous valve, or for delivering a heart valve prosthesis within a previously-implanted prosthesis. Furthermore, there is no intention to be bound by any expressed or implied theory presented in the preceding technical field, background, brief summary or the following detailed description.

[0075] The figures for embodiments described herein may have various components omitted for clarity. For example, and not by way of limitation, the figures may illustrate a retainer of a delivery catheter and / or a portion of a heart valve prosthesis, however it will be understood that embodiments of retainers described herein are part of a delivery catheter, and that any portion of a heart valve prosthesis described and illustrated in embodiments herein are part of a complete heart valve prosthesis.

[0076] Embodiments hereof relate to delivery systems for percutaneously delivering a heart valve prosthesis with improved release. The delivery system includes a delivery catheter and a heart valve prosthesis. The delivery catheter includes a retainer with at least one pocket. The heart valve prosthesis includes at least one connector. Each pocket of the retainer is configured to receive a corresponding connector of the heart valve prosthesis therein for delivery and deployment of the heart valve prosthesis to a desired treatment location. Embodiments hereof are directed to improved pockets of the retainer and improved connectors of the heart valve prosthesis to improve release characteristics of the connectorsfrom the pockets when deploying the heart valve prosthesis from the delivery catheter at the desired treatment location.

[0077] FIGS. 1-7 illustrate a delivery system 100 according to embodiments hereof. The delivery system 100 includes a delivery catheter 200 and a heart valve prosthesis 300 disposed in the delivery catheter 200. The delivery catheter 200 is configured to deliver and deploy or release the heart valve prosthesis 300 at a desired treatment location. FIGS. 1 and 2 show a side view and cross-section view of the delivery system 100. The delivery catheter 200 includes a luer or handle 204, an outer sheath 202, an inner shaft 208, and a middle shaft or middle member 206. The handle 204 enables a clinician to manipulate a distal portion of the delivery catheter 200 and may include actuators for moving parts of the delivery system relative to other parts, such as an actuator 210 for moving the outer sheath 202 relative to the inner shaft 208. A distal portion of the outer sheath 202, referred to as a capsule 216, is configured to surround and compressively restrain the heart valve prosthesis 300 in a radially compressed configuration during delivery to the treatment site, e.g., a native heart valve, and the outer sheath 202 is retracted from the heart valve prosthesis 300 to expose the heart valve prosthesis 300 such that it self-expands. The inner shaft 208 is coupled to the handle 204 and movement of the handle 204 translates to movement of the inner shaft 208 and a distal tip 213 coupled to a distal end of the inner shaft 208. The inner shaft 208 and distal tip 213 may also be translated relative to the outer sheath 202 and the handle 204 via a tip retractor (not shown). The inner shaft 208 defines a lumen 211 configured to receive a guidewire GW as shown in FIG. 2. In the embodiment shown, the middle member 206 is disposed between the inner shaft 208 and the outer sheath 202. The middle member 206 includes a spindle or retainer attached to a distal portion thereof for receiving tabs or connectors 322 of the heart valve prosthesis 300, as shown in FIG. 3.

[0078] The outer sheath 202 includes a proximal end (not shown) operatively coupled to the actuator 210 of the handle 204. As shown in FIG. 2, the outer sheath 202 defines a lumen 214 and is slidingly and concentrically disposed over the middle member 206. As used herein, the term “slidingly” denotes back-and-forth movement in a longitudinal direction, along or generally parallel to a central longitudinal axis CLA of the delivery catheter 200. The middle member 206 is disposed between the outer sheath 202 and the inner shaft 208. The middle member 206 has a proximal end (not shown), which terminateswithin the handle 204, and a distal end 218 (FIG. 3) disposed inside the outer sheath 202 when the outer sheath 202 is disposed over the heart valve prosthesis 300. As best shown in FIG. 2, the middle member 206 defines a lumen 207 and is concentrically disposed over the inner shaft 208. The spindle or retainer 220 is coupled to the distal end 218 of the middle member 206, as shown in FIG. 3. The inner shaft 208 includes a proximal end (not shown) coupled to the handle 204 and a distal end 209 coupled to the distal tip 213, as shown in FIG. 3.

[0079] FIG. 4 shows a prior art retainer 220. The retainer 220 is a tubular component including a proximal end 224, a distal end 226, and a lumen 222 extending from the proximal end 224 to the distal end 226. The retainer 220 further includes a body portion 227 including a pocket 230 configured to receive a tab or connector 322 of the heart valve prosthesis 300 to releasably couple the heart valve prosthesis 300 to the delivery catheter 200 for delivery and release at a desired treatment location. The body portion 227 includes an outer surface 229. The pocket 230 is a depressed area or surface 231 of the retainer 220 defined by a proximal wall 232, a distal wall 234, and side walls 236A, 236B extending between the proximal wall 232 and the distal wall 234. The side walls 236A, 236B are disposed on and spaced equally from a center line CL1 of the pocket 230. An opening 238 in the distal wall 234 enables a stem 324 of a connector 322 of the heart valve prosthesis 300 to extend therethrough. Accordingly, the distal wall 234 includes a first portion 234A on a first side of a centerline CL1 of the pocket 230, and a second portion 234B of a second side of the centerline CL1, opposite the first portion 234A. As used herein, the centerline CL1 of the pocket 230 is defined as a line extending generally through an apex 260 of the proximal wall 232 and a distal end 233 of the body portion 227 adjacent to a proximal end of a collar 244. The proximal wall 232 of the pocket 230 extends proximally and circumferentially in an arc from a first end 258 to an apex 260, and then distally and circumferentially in an arc to a second end 262. Thus, the apex 260 is disposed proximally of the first and second ends 258, 262 of the proximal wall 232. In embodiments herein, the centerline CL1 of the pocket 230 generally bisects the opening 238.

[0080] The retainer 220 further includes the collar 244 at the distal end 226 of the retainer 220. While only one pocket 230 is shown in FIG. 4, the retainer 220 includes pockets 230 equal to the number of tabs or connectors 322 of the heart valve prosthesis 300.

[0081] FIGS. 5-6 illustrate a side view and an outflow view, respectively, of an example heart valve prosthesis 300 that can be used with the delivery catheter 200 described herein. The heart valve prosthesis 300 is illustrated herein to facilitate description of a plurality of paddles or connectors 322 of the heart valve prosthesis 300. The plurality of connectors 322 are configured to releasably couple the heart valve prosthesis 300 to the delivery catheter 200. The heart valve prosthesis 300 is merely exemplary and is described in more detail in U.S. Patent No. 8,226,710 to Nguyen et al., which is assigned to the same assignee as the present disclosure, and which is herein incorporated by reference in its entirety. It is understood that any number of alternate heart valve prostheses may be used with the methods and devices described here in. The heart valve prosthesis 300 is presented by way of example only, and the existing components illustrated in FIGS. 5-6 may be removed and / or additional components may be added to the heart valve prosthesis 300.

[0082] The heart valve prosthesis 300 includes a stent or frame 302 and a prosthetic valve 304 including at least one leaflet 306 configured to regulate flow through the heart valve prosthesis 300. The heart valve prosthesis 300 includes a first end 308 and a second end 310. In embodiments herein, the first end 308 of the heart valve prosthesis 300 is an inflow end, and the second end 310 is an outflow end. The leaflets 306 are attached to the frame 302 such that when pressure at the first (inflow) end 308 exceeds pressure at the second (outflow) end 310, the leaflets 306 open to allow blood flow through the heart valve prosthesis 300 from the first end 308 to the second end 310. When the pressure at the second (outflow) end 310 exceeds pressure at the first (inflow) end 308, the leaflets 306 close to prevent blood flow from the second end 310 to the first end 308.

[0083] The frame 302 of the heart valve prosthesis 300 is a tubular structure defining a central lumen 312 of the heart valve prosthesis 300. The frame 302 includes a plurality of struts 314 arranged to form a plurality of side cells or side openings 316. The struts 314 come together to form crowns 318 or nodes 320, as shown in FIG. 5. The frame 302 is configured to secure the prosthetic valve 304 within the central lumen 312 and to secure the heart valve prosthesis 300 in place in the vasculature of the patient.

[0084] The frame 302 further includes the plurality of connectors 322 for releasably coupling the heart valve prosthesis 300 to a delivery catheter, for example the delivery catheter 200. FIGS. 3 and 5-7 show prior art connectors 322, with each connector 322extending from an endmost crown 318 of the frame 302 of the heart valve prosthesis 300 and is connected by a stem 324. In the example shown, each connector 322 includes a bulbous head or paddle 325 coupled to the stem 324. While shown with two (2) connectors 322 in embodiments herein, this is not meant to be limiting, and the heart valve prosthesis 300 may include more or fewer connectors 322.

[0085] FIG. 7 illustrates a close-up view of the prior art connector 322. The connector 322 includes the stem 324 and the bulbous head or paddle 325. The paddle 325 is defined by a first edge 326, a second edge 328, a third edge 330, a fourth edge 332, and a fifth edge 334, forming a generally rectangular shape with curved comers and a curved distal edge (third edge 330). It is noted that the third edge 330 may be referred to herein as the distal edge as the connector 322 extends from the outflow end of the frame of the heart valve prosthesis 300. However, in other embodiments, the connectors of a heart valve prosthesis may extend from an inflow end of the heart valve prosthesis such that a corresponding third edge would be a proximal edge. Further, the heart valve prosthesis 300 is oriented such that the outflow end thereof is arranged proximally with respect to the delivery catheter 200. The first edge 326 and the fifth edge 334 are each disposed adjacent to the stem 324, on opposite sides of and generally transverse to a centerline CL2 of the connector 322. The second edge 328 distally extends from the first edge 326 and is generally parallel to the centerline CL2 of the connector 322. The fourth edge 332 distally extends from the fifth edge 334 and generally parallel to the centerline CL2 of the connector 322 such that the second edge 328 and the fourth edge 332 are equally spaced from the centerline CL2 and on opposite sides thereof. The third edge 330 is an arc extending from a distal end of the second edge 328 to a distal end of the fourth edge 332.

[0086] FIGS. 8-12 show a connector 422 for use with a heart valve prosthesis, such as the heart valve prosthesis 300, according to embodiments hereof. The connector 422 can be used with the heart valve prosthesis 300 described above or other heart valve prostheses, as explained above. FIG. 8 and FIGS. 10-12 show one connector 422. However, as described above, the heart valve prosthesis 300 may include more connectors 422, such as two connectors 422, three connectors 422, or four connectors 422, or more than four connectors 422.

[0087] In embodiments herein, each connector 422 of FIGS. 8-12 is generally a halfpaddle shape. In a non-limiting example, each connector 422 extends from an endmost crown 318 of the frame 302 and is connected by a stem 424. Each connector 422 is configured to be disposed within a pocket, for example the pocket 230 of the retainer 220, to releasably couple the heart valve prosthesis 300 to the delivery catheter 200.

[0088] FIG. 8 illustrates the connector 422. The connector 422 includes the stem 424 and a bulbous head or paddle 425. The paddle 425 is defined by a first edge 426, a second edge 428, a third edge 430, and a fourth edge 432, forming a generally rectangular shape with curved comers. It is noted that the second edge 428 may be referred to herein as the distal edge as the connector 422 extends from the outflow end of the frame 302 of the heart valve prosthesis 300. However, in other embodiments, the connectors of a heart valve prosthesis may extend from an inflow end of the heart valve prosthesis such that a corresponding third edge would be a proximal edge. Further, the heart valve prosthesis 300 is oriented such that the outflow end thereof is arranged proximally with respect to the delivery catheter 200.

[0089] In the embodiment shown, the first edge 426 extends distally from a first edge 424A of the stem 424 on a first side of a centerline CL2 of the stem 424 of the connector 422 which generally bisects the stem 424 longitudinally. The first edge 426 extends generally parallel to the centerline CL2 of the stem 424 of the connector 422.

[0090] The fourth edge 432 of the connector 422 extends generally perpendicular to the centerline CL2 of the stem 424 from a distal end of a second edge 424B of the stem 424 of a second side of the centerline CL2 opposite the first side. The third edge 430 of the connected extends distally from the fourth edge 432 and is generally parallel to the centerline CL2 of stem 424 of the connector 422. In embodiments herein, due to the first edge 426 of the connector 422 extending distally from first edge 424A of the stem 424, and the fourth edge 432 extending perpendicularly away from the centerline CL2 prior to the third edge 430 extending distally from the fourth edge 432, the first edge 426 and the third edge 430 are unequally spaced from the centerline CL2 and on opposite sides thereof. The second edge 428 is an arc extending from a distal end of the first edge 426 to a distal end of the third edge 430. With the first edge 426 and the third edge 430 unequally spaced from thecenterline CL2 and on opposite sides thereof, the connector 422 may also be described as asymmetric relative to the central longitudinal axis CL2.

[0091] FIG. 9 illustrates two connectors 422 disposed on the heart valve prosthesis 300. In embodiments herein, a first connector 422A is disposed on a first side of the heart valve prosthesis 300, and a second connector 422B is disposed on a second side of the heart valve prosthesis 300. The heart valve prosthesis 300 is configured such that the first edge 426 of the first connector 422A is oriented in a first direction DI, as indicated in FIG. 9, and the first edge 426 of the second connector 422B is oriented in a second direction D2, wherein the first direction DI is opposite to the second direction D2. It should be noted that these directions are based on a side view of the heart valve prosthesis 300 with the directions being lateral. Stated another way, the third edges 430 of the two connectors 422A, 422B both face in a counterclockwise direction, with the direction being circumferential. Such an arrangement may contribute to equalizing forces on the heart valve prosthesis 300 and limit asymmetric loading thereon to prevent infolding during loading into a delivery device or catheter.

[0092] FIG. 10 is a side view of the retainer 220 of the delivery catheter 200 with the connector 422 of the heart valve prosthesis 300 disposed thereon. The connector 422 is disposed within the pocket 230 of the retainer 220. The stem 424 of the connector 422 is disposed within the corresponding opening 238 of the retainer 220. The second edge 428 of the paddle 425 of the connector 422 is disposed adjacent to the proximal wall 232 of the retainer 220. With the outer sheath 202 of the delivery catheter 200 disposed over the retainer 220 and the connector 422, the outer sheath 202 retains the connector 422 within the pocket 230 of the retainer 220 to releasably couple the connector 422 to the retainer 220. Each connector 422 is longitudinally and rotationally constrained within the pocket 230 of the retainer 220 by the proximal wall 232, the distal wall 234, and the side walls 236A, 236B. In greater detail, the second edge 428 of the connector 422 is disposed adjacent to the proximal wall 232 of the retainer 220. The proximal wall 232 prevents the connector 422 from moving in a proximal direction relative to the delivery catheter 200. The fourth edge 432 of the connector 422 is disposed adjacent to the distal wall 234 of the retainer 220, with the stem 324 extending through the opening 238. The distal wall 234 prevents the connector 422 from moving in a distal direction relative to the delivery catheter 200, such as but notlimited to during loading of the heart valve prosthesis 300 into the delivery catheter 200 or recapture of the heart valve prosthesis 300. Each connector 422 is rotationally constrained by the stem 424 disposed within the corresponding opening 238 of the retainer 220 and by the side walls 236A, 236B adjacent to the first edge 426 and the third edge 430. The connector 422 is radially retained adjacent to the outer surface 231 of the pocket 230 of the retainer 220 by the outer sheath 202.

[0093] Referring to FIGS. 11-12, the connector 422 of the heart valve prosthesis 300 is shown rotated within the pocket 230 of the retainer 220. Due to rotational forces, the connector 422 may rotate when released by the delivery catheter 200 as previously described. The first edge 426 and the stem 424 of the connector 422 is in contact with the distal wall 234 of the pocket 230 of the retainer 220, as best illustrated in FIG. 12. Due to the straight or smooth shape of the first edge 426 distally extending from the stem 424, the first edge 426 presents no surface to hang-up or catch on the distal wall 234 of the retainer 220. In other words, the first edge 426 of the connector 422 does not present an edge that can get caught on the distal wall 234 of the pocket 230. Thus, as shown in FIGS. 11-12, if the connector 422 is rotated within the pocket 230, the first edge 426 will not get caught on the distal wall 234 of the pocket 230. Instead, the first edge 426 will ride up and over the distal wall 234 and escape the pocket 230, thereby reducing or eliminating paddle / connector hang up and improving release of the heart valve prosthesis.

[0094] The connector 422 in FIGS. 11 and 12 is shown rotated in a certain direction. In particular, the connector 422 is rotated such that the first edge 426 faces radially inwardly and the third edge 430 faces radially outwardly. The orientation of the connector 422 on the heart valve prosthesis 300, that is, the circumferential direction that the third edge 426 of each connector 422 faces, may be selected such that the rotational forces acting on the connector 422 will tend to rotate the connector as shown (i.e., the first edge radially inwardly).

[0095] FIGS. 13-16 show a retainer 520 according to an embodiment hereof. The retainer 520 is similar to the retainer 220 shown in FIG. 4 except as described herein. Therefore, all of the details described above with respect to the retainer 220 are incorporated into the description of FIGS. 13-16 and the same reference numerals are used. Thus, generally, as described above, the retainer 520 includes the proximal end 224, the distal end226, and the lumen 222. The retainer 220 further includes the pocket 230 configured to receive a tab or connector of the heart valve prosthesis 300. The pocket 230 is defined by the proximal wall 232, the distal wall 534, and the side walls 236A, 236B. The pocket 230 includes an opening 538 in the distal wall 534 to enable a stem of a connector of the heart valve prosthesis 300 to extend therethrough. However, unlike the retainer 220 of FIG. 4, the pocket 230 of the retainer 520 only includes one portion 534B of the distal wall 534, as compared to the first and second portions 234A, 234B of the distal wall 234 of the retainer 220. Although there is only one portion of the distal wall, it is labeled as the “second portion 534B” for consistency with the description above regarding the retainer 220. Accordingly, the pocket 230 is defined by the proximal wall 232, the second portion 534B of the distal wall 534, and the side walls 236A, 236B. In other words, the opening 538 is circumferentially longer than the opening 238 of the retainer 220 due to the elimination of the first portion 234A of the distal wall 234. Further, in the embodiment shown, the opening 538 is asymmetrical with respect to the centerline CL1. In other words, the circumferential length of the portion of the opening 538 on a first side of the centerline CL1 (i.e., the side without the distal wall 534) is longer than the circumferential length of the portion of the opening 538 on a second side of the centerline CL1 (i.e., the side with the distal wall 534).

[0096] FIG. 14 is a side view of the retainer 520 with the connector 322 of the heart valve prosthesis 300 disposed therein. The stem 324 of the connector 322 is disposed within the opening 538 of the retainer 520. The first edge 326 of the connector 322 is disposed adjacent to the opening 538 of the retainer 520, as there is no distal wall adjacent the first edge 326. The second and fourth edges 328, 332 are disposed adjacent to the side walls 236A, 236B, respectively, of the retainer 520. The side walls 236A, 236B prevent the connector 322 from rotating in a circumferential direction relative to the delivery catheter 200. The third edge 330 of the connector 322 is disposed adjacent to the proximal wall 232 of the retainer 520. The proximal wall 232 of the retainer prevents the connector 322 from moving in a proximal direction relative to the delivery catheter 200. The fifth edge 334 of the connector 322 is disposed adjacent to the second portion 534B of the distal wall 534 of the retainer 520. The second portion 534B of the distal wall 534 prevents the connector 322 from moving in a distal direction relative to the delivery catheter 200. Thus, each connector 322 is rotationally constrained by the stem 324 disposed within the corresponding opening538 of the retainer 520 and by the side walls 236A, 236B adjacent to the second edge 326 and the fourth edge 332 of the connector 322. The connector 322 is radially retained adjacent to the outer surface 231 of the pocket 230 of the retainer 520 by the outer sheath 202 of the delivery catheter 200.

[0097] Referring to FIGS. 15-16, the connector 322 of the heart valve prosthesis 300 is shown rotated within the pocket 230 of the retainer 520. Due to rotational forces, the connector 322 may rotate when released by the delivery catheter 200 as previously described. The rotated connector 322 is not restricted from moving distally with respect to the retainer 520 because the first edge 326 of the paddle 325 does not contact the distal wall 534 because there is no distal wall 534 adjacent the first edge 326. In other words, as the distal wall 534 does not extend adjacent to the first edge 326 of the connector 322, the pocket 230 of the retainer 520 presents no surface upon which the rotated first edge 326 of the connector 322 may hang-up or catch. The first edge 326 is therefore free to release, unrestricted, from the pocket 230. Accordingly, the omission of a first portion of the distal wall 534 adjacent the first edge 326 of the connector 322 reduces or eliminates paddle / connector hang-up, thereby improving release of the heart valve prosthesis.

[0098] As explained above, the direction the connector 322 is likely to rotate may be determined based on the circumferential location of the connector 322 and the vascular path or route taken by the catheter 200. Thus, the portion of the distal wall 534 of the retainer 520 to be removed may be determined such that when the connector 322 rotates in the particular direction, the first edge 326 (or the fifth edge 334 if the connector 322 rotates in the opposite direction) does not hang up on the distal wall 534.

[0099] FIGS. 17-20 show another retainer 620 according to embodiments hereof. In embodiments, the retainer 620 is similar to the retainer 220 shown in FIG. 4 except as described herein. Therefore, all of the details described above with respect to the retainer 220 are incorporated into the description of FIGS. 17-20 and the same reference numerals are used, except where the retainers differ. Thus, as described above, the retainer 620 includes the proximal end 224, the distal end 226, and the lumen 222. The retainer 620 further includes a pocket 630. In embodiments herein, the pocket 630 is a generally halfpaddle shape as compared to the pocket 230. The pocket 630 of the retainer 620 is configured to receive a tab or connector of a heart valve prosthesis, such as the connecter422 of FIGS. 8-12. The pocket 630 is defined by a proximal wall 632, a distal wall 634, side walls 636A, 636B, and an opening 638 in the distal wall 634 to enable a stem 424 of the connector 422 of the heart valve prosthesis 300 to extend therethrough.

[0100] In embodiments herein, the first side wall 636A extends proximally from the distal end 233 of the body portion 227 of the retainer 620. The first side wall 636A extends generally parallel to the center line CL1 of the pocket 630. The first side wall 636A, by extending from the distal end 233 of the body portion 227, essentially subsumes the first portion 234A of the distal wall 234 of the embodiment of FIG. 4. Thus, it has been described as the pocket 620 not including the first portion of the distal wall. The second side wall 636B extends between the proximal wall 632 and the second portion 634B of the distal wall 634. The side walls 636A, 636B are disposed on opposite sides of the centerline CL1 of the pocket 630. In embodiments herein, the side walls 636A, 636B are unequally spaced from the center line CL1 of the pocket 630, as shown in FIG. 17. It is noted that the centerline CL1 in this embodiment is defined as a longitudinal line that bisects the opening 638 of the pocket 630. In greater detail, the first side wall 636A is disposed a first circumferential distance from the centerline CL1 and the second side wall 636B is disposed a second circumferential distance from the centerline CL1. In embodiments, the first distance is smaller than the second distance. Stated another way, the first side wall 636A is closer to the centerline CL1 than the second side wall 636B.

[0101] Similar to the embodiment described above, the proximal wall 632 extends from a proximal end of the first side wall 636A to a proximal end of the second side wall 636B. The proximal wall 632 is curved or arched, but is shorter than the proximal wall 232 described above because the first side wall 636Ais closer to the centerline CL1 than the first side wall 236A in the embodiment above.

[0102] In embodiments, the first side wall 636A of the pocket 630 may be rounded, tapered, or otherwise smoothed such that the transition from the outer surface 631 of the pocket 630 to the outer surface 229 of the body portion 227 is smooth, thereby enabling the connector 422 to more easily exit the pocket 630 if rotated or twisted in the direction of the first side wall 636A during deployment.

[0103] FIG. 18 is a side view of the retainer 620 of the delivery catheter 200 with the connector 422 of the heart valve prosthesis 300 disposed therein. The stem 424 of theconnector 422 is disposed within the opening 238 of the retainer 620 and the paddle 425 is disposed within the pocket 630. The first edge 426 of the paddle 425 is disposed adjacent the first side wall 636A, the second edge 428 of the paddle 425 is disposed adjacent to the proximal wall 632, the third edge 430 of the paddle 425 is disposed adjacent the second side wall 636B, and the fourth edge 432 of the paddle 425 is disposed adjacent the distal wall 634 (in particular, the second portion 634B). With the paddle 425 disposed in the pocket 630, the first and second side walls 636A, 636B prevent circumferential movement of the connecter 422, the proximal wall 632 prevents proximal movement of the connector 422, and the distal wall 634 prevents distal movement of the connector 422. With the outer sheath 202 (FIG. 1) of the delivery catheter 200 disposed over the retainer 620 and the connector 422, the outer sheath 202 retains the connector 422 within the pocket 230 of the retainer 620 to releasably couple the connector 422 to the retainer 620, and the heart valve prosthesis 300 to the delivery catheter 200. Each connector 422 is longitudinally and rotationally constrained within the pocket 230 of the retainer 620 by the proximal wall 232, the second portion 234B of the distal wall 234, and the side walls 236A, 236B. Each connector 422 is radially or compressively restrained by the outer sheath 202.

[0104] Referring to FIGS. 19-20, the connector 422 of the heart valve prosthesis 300 is shown rotated within the pocket 230 of the retainer 620, which may occur upon release from the delivery catheter 200 due to rotational forces. The rotated connector 422 is not restricted from moving distally out of the pocket 630 because the first edge 426 of the connector 422 is not in contact with the distal wall 634 of the retainer 620 as the retainer 620 has only the second portion 634B of the distal wall 634. Further, the first edge 426 is connector 422 is a smooth transition from the stem 424 (i.e., there is not a circumferential edge extending from the stem 424 before the longitudinal first edge 426). In other words, the pocket 630 of the retainer 620 presents no surface upon which the rotated first edge 426 of the connector 422 may hang-up or catch. The first edge 426 is therefore free to release, unrestricted, from the pocket 630. Accordingly, the combination of the shape of the connecter 422 and the shape of the pocket 630reduces or eliminates paddle / connector hang-up, thereby improving release of the heart valve prosthesis.

[0105] FIGS. 21-24 show a connector 722 that can be used with a heart valve prosthesis, such as the heart valve prosthesis 300, according to another embodiment hereof. Theconnector 722 is similar to the connector 322 previously described with respect to FIG. 7, except as described herein. Therefore, all of the details described above are incorporated into the description of FIGS. 21-24. Thus, generally, the connector 722 includes a stem 724 and a paddle 725. The paddle 725 is defined by a first edge 726, a second edge 728, a third edge 730, and a fourth edge 732. In embodiments herein, each connector 722 is generally a paddle shape with an angled or chamfered first edge 726. Each connector 722 is configured to be disposed within a pocket, for example the pocket 230 of the retainer 220, to releasably couple the heart valve prosthesis 300 to the delivery catheter 200.

[0106] FIG. 21 illustrates the connector 722. The first edge 726 and the fourth edge 732 of the connector 722 are each disposed adjacent to the stem 724, on opposite sides of a centerline CL2 longitudinally bisecting the stem 724. The first edge 726 extends proximally at an angle 61 from a distal end 727 of a first edge 724A of the stem 724 on a first side of the centerline CL2. In embodiments herein, the angle 61 may be between about 20° to about 80°. The fourth edge 732 extends from a distal end 727 of a second edge 724B of the stem 724 on a second side of the centerline CL2 and extends generally perpendicular to the centerline CL2 of the stem 724. The third edge 730 extends distally from the fourth edge 732 and is generally parallel to the centerline CL2 of stem 724. The second edge 728 is an arc extending from a distal end of the first edge 726 to a distal end of the third edge 730.

[0107] The retainer 220 of the delivery catheter 200 with the connector 722 of the heart valve prosthesis 300 disposed therein is shown in FIG. 22. The connector 722 is disposed within the pocket 230 of the retainer 220, with the stem 724 of the connector 722 disposed within the opening 238 and the paddle 725 is disposed within the pocket 230. The first edge 726 of the paddle 725 is disposed first distal wall portion 234A and the first side wall 236A, the second edge 728 of the paddle 725 is disposed adjacent to the proximal wall 232, the third edge 730 of the paddle 725 is disposed adjacent the second side wall 236B, and the fourth edge 732 of the paddle 725 is disposed adjacent the second portion 234B of the distal wall 634. With the paddle 725 disposed in the pocket 230, the first and second side walls 236A, 236B prevent circumferential movement of the connector 722, the proximal wall 232 prevents proximal movement of the connector 722, and the distal wall 234 prevents distal movement of the connector 722. With the outer sheath 202 (FIG. 1) disposed over the retainer 220 and the connector 722, the outer sheath 202 retains the connector 722 withinthe pocket 230 of the retainer 220 to releasably couple the connector 722 to the retainer 220 such that the heart valve prosthesis 300 is releasably coupled to the delivery catheter 200. Each connector 722 is longitudinally and rotationally constrained within the pocket 230 of the retainer 620 by the proximal wall 232, the distal wall 234, and the side walls 236A, 236B. Each connector 722 is radially or compressively restrained within the pocket 230 of the retainer 620 by the outer sheath 202.

[0108] Referring to FIGS. 23-24, the connector 722 of the heart valve prosthesis 300 is shown rotated within the pocket 230 of the retainer 220, which may occur upon release from the delivery catheter 200 due to rotational forces. The first edge 726 of the connector 722 is in contact with first portion 234A of the distal wall 234 of the pocket 230 of the retainer 220. The angled the first edge 726 presents a generally smooth, angled surface with no edge to hang-up or catch on the first portion 234A of the distal wall 234 of the retainer 220. Thus, as shown in FIG. 24, if the connector 722 is rotated within the pocket 230, the first edge 726 will not get caught on the first portion 234A of the distal wall 234 of the pocket 230. Instead, the first edge 726 may slide up and over the distal wall 234 and out of the pocket 230, thereby reducing or eliminating paddle / connector hang up and improving release of the heart valve prosthesis 300.

[0109] FIGS. 25-29 show a retainer 820 according to embodiments hereof and a connector 922 according to embodiments hereof. The retainer 820 is similar to the retainer 220 shown in FIG. 4 except as described herein. Therefore, all of the details described above are incorporated into the description of FIGS. 25-29 and similar reference numerals are used. Thus, as described above, the retainer 820 generally includes the proximal end 224, the distal end 226, and the lumen 222. The retainer 820 further includes a pocket 830 configured to receive a tab or connector of a heart valve prosthesis, for example, and not by way of limitation, the connector 922 of the heart valve prosthesis 300, as described below. However, unlike the retainer 220 of FIG. 4, the pocket 830 of the retainer 820 is a generally diamond shape.

[0110] In embodiments, the pocket 830 of the retainer 820 is of a general diamond shape and is defined by a first side wall 836A, a second side wall 836B, a third side wall 836C, and a fourth side wall 836D, as shown in FIG. 25. The pocket 830 includes the opening 238 in the distal wall 234 to enable a stem of a connector of a heart valve prosthesis to extendtherethrough. In embodiments herein, the first and the fourth side walls 836A, 836D extend proximally from the distal wall 234 to a midpoint 870A, 870B, respectively, on opposite sides of the centerline CL1 of the pocket 830. The first side wall 836A extends proximally from the distal wall 234 at an angle 02 relative to the centerline CL1 on a first side of the centerline CL1, and in a direction away from the centerline CL1 in the proximal direction. The fourth side wall 836D extends proximally from the distal wall 234 at an angle 03 relative to the centerline CL 1 on a second side of the centerline CL1, opposite the first side, and in a direction away from the centerline CL1 in the proximal direction. In an embodiment, the angles 02 and 03 are equal, but on opposite sides of the centerline CL1. In embodiments herein, the angles 02, 03 may be between about 15° to about 75° or about 30° to about 60°.[oni] The second and the third side walls 836B, 836C extend in a proximal direction from the midpoint 870A, 870B, respectively, to an apex 860 of the pocket 830. The second side wall 836B extends proximally from the midpoint 870A to the apex 860 at an angle 04 relative to the centerline CL1 and in a direction towards the centerline from the midpoint 870A towards the apex 860 (i.e., in the proximal direction). Similarly, the third side wall 836D extends proximally from the midpoint 870B to the apex 860 at an angle 05 relative to the centerline CL1 and in a direction towards the centerline CL1 from the midpoint 870B towards the apex (i.e., in the proximal direction). In an embodiment, the angles 04 and 05 are equal, but on opposite sides of the centerline CL1. In embodiments herein, the angles 04, 05 may be between about 15° to about 75° or about 30° to about 60°.

[0112] FIGS. 25-29 show a connector 922 according to another embodiment hereof. The connector 922 of FIGS. 25-29 is similar to the connector 322 of FIG. 7, except as described herein. Therefore, all of the details described above for similar features are incorporated into the description of FIGS. 25-29. Accordingly, each connector 922 includes a stem 924 and a paddle 925. Each connector 922 is configured to be disposed within a pocket, for example the pocket 830 of the retainer 820, to releasably couple a heart valve prosthesis, for example the heart valve prosthesis 300, to a delivery catheter, for example, the delivery catheter 200. The connector 922 of FIGS. 25-29 includes a generally diamond shaped paddle 925 instead of the generally rectangular paddle 325 described above.

[0113] As shown in FIG. 26, the paddle 925 of the connector 922 is defined by a first edge 926, a second edge 928, a third edge 930, and a fourth edge 932, forming a general diamond shape. The first edge 926 and the fourth edge 932 are each disposed adjacent to the stem 924, on opposite sides of a centerline CL2 longitudinally bisecting the stem 924 of the connector 922. The first edge 926 extends distally from a distal end 927 of a first edge 924A of the stem 924 to a first midpoint 940A on a first side of the centerline CL2. The first edge 926 extends distally at an angle 66 relative to the centerline CL2 and extending away from the centerline CL2. The fourth edge 932 extends distally from the distal end 927 of a second edge 924B of the stem 924 to a second midpoint 940B on a second side of the centerline CL2, opposite the first side. The fourth edge 932 extends distally at an angle 67 relative to the centerline CL2. In an embodiment, the angles 66 and 67 are equal, but on opposite sides of the centerline CL2. In embodiments herein, the angles 66, 67 may be between about 15° to about 75° or about 30° to about 60°.

[0114] The second and the third edges 928, 930 extend in a distal direction from the corresponding first and second midpoints 940A, 940B, respectively, to an apex 942. In greater detail, the second edge 928 extends distally from the first midpoint 940Ato the apex 940 at an angle 68 relative to the centerline CL2 and in a direction towards the centerline CL2. In a similar fashion, the third edge 930 extends distally from the second midpoint 940B to the apex 942 at an angle 69 relative to the centerline CL2 and in a direction towards the centerline CL2. In an embodiment, the angles 68 and 69 are equal, but on opposite sides of the centerline CL2. In embodiments herein, the angles 68, 69 may be between about 30° to about 60°.

[0115] FIG. 27 is a side view of the retainer 820 of the delivery catheter 200 with the connector 922 of the heart valve prosthesis 300 disposed therein. The stem 924 of the connector 922 is disposed within the opening 238 of the retainer 820. The first, second, third, and fourth edges 926, 928, 930, 932 of the paddle 925 of the connector 922 are disposed adjacent to the corresponding first, second, third, and fourth side walls 836A, 836B, 836C, 836D, respectively. The connector 922 is longitudinally and circumferentially constrained within the pocket 830 by the first, second, third, and fourth side walls 236A, 236B, 236C, 236D. With the outer sheath 202 (FIG. 1) of the delivery catheter 200 disposed over the retainer 820 and the connector 922, the outer sheath 202 (FIG. 1) retains theconnector 922 within the pocket 830 of the retainer 820 to releasably couple the connector 922 to the retainer 820, and accordingly, the heart valve prosthesis 300 to the delivery catheter 200. The connector 922 is radially or compressively restrained by the outer sheath 202 (FIG. 1).

[0116] Referring to FIGS. 28-29, the connector 922 of the heart valve prosthesis 300 is shown rotated within the pocket 830 of the retainer 820, which may occur upon release from the delivery catheter 200 due to rotational forces previously described. The first edge 926 of the connector 922 is in contact with the first side wall 836A of the pocket 830. The straight or smooth edge of the first edge 926 presents no surface to hang-up or catch on the first side wall 836A of the pocket 830. Thus, as shown in FIGS. 28-29, if the connector 922 is rotated within the pocket 830, the first edge 926 of the paddle 925 will not get caught on the first side wall 836A of the pocket 230, thereby reducing or eliminating paddle / connector hang up and improving release of the heart valve prosthesis.

[0117] FIGS. 30-35 show a retainer 1020 according to embodiments hereof and a modified embodiment of the connector 922 according to embodiments hereof. In embodiments, the retainer 1020 is similar to the retainer 220 shown in FIG. 4 except as described herein. Thus, all of the details described above are incorporated into the description of FIGS. 30-35 and the same or similar reference numerals are used. Thus, the retainer 1020 generally includes the proximal end 224, the distal end 226, and the lumen 222. The retainer 1020 further includes a pocket 1130 configured to receive a tab or connector of a heart valve prosthesis. However, unlike the retainer 220 of FIG. 4, the pocket 1130 of the retainer 1020 is a general teardrop shape. In embodiments herein, the pocket 1130 of the retainer 1020 and / or the connector 922 of the heart valve prosthesis 300 described previously may include fillets or smoothed edges and transitions as described below.

[0118] As shown in FIG. 30, the pocket 1130 of the retainer 1020 is a general teardrop shape and is defined by a first side wall 1136A, a second side wall 1136B, and a curved proximal wall 1132. In embodiments, the first side wall 1136A and the second side wall 1136B may be curved. The opening 1138 through the distal wall 1134 of the pocket 1130 enables the stem of a connector of the heart valve prosthesis to extend there through. Each pocket 1130 of the retainer 1020 is configured to receive a corresponding connector, forexample, and not by way of limitation, the connector 922 of the heart valve prosthesis 300 to releasably couple the heart valve prosthesis 300 to the delivery catheter 200 for delivery and release at a desired treatment location.

[0119] In embodiments herein, the first and the second side walls 1136A, 1136B proximally extend from the distal wall 1134 on opposite sides of the centerline CL1 of the pocket 1130. In embodiments, the first side wall 1136A extends proximally from the distal wall 1134 on a first side of the centerline CL1. The first side wall 1136A extends in a first curve away from the centerline CL1 to a proximal end of the first side wall 1136A. In embodiments, the first side wall 1136A may include two curves, a first, distal curve that is convex relative to the centerline CL1 and a second, proximal curve that is concave relative to the centerline CL1. Similarly, the second side wall 1136B extends proximally from the distal wall 1134 on a second side of the centerline CL1, opposite the first side. The second side wall 1136B extends in a first curve away from the centerline CL1 to a proximal end of the second side wall 1136B. In embodiments, the second side wall 1136B may include two curves, a first, distal curve that is convex relative to the centerline CL1 and a second, proximal curve that is concave relative to the centerline CL1. The first and second side walls 1136A, 1136B may be mirror images of each other on opposite sides of the centerline CL1 such that the pocket 1130 is symmetric relative to the centerline CL1. The proximal wall 1132 of the pocket 1130 extends proximally and circumferentially in an arc from a first end 1158 adj acent the proximal end of the first side wall 1136A to an apex 1160, and then distally and circumferentially in an arc to a second end 1162 adjacent the proximal end of the second side wall 1136B.

[0120] In embodiments herein, the walls 1136A, 1136B, 1132 may be rounded or smoothed between various the outer surface 1131 of the pocket 1130 and the outer surface 229 of the body portion 227 of the retainer 1020 to improve release characteristics of a paddle of a heart valve prosthesis disposed therein.

[0121] In embodiments, the connector 922 may include fillets or rounding or smoothing and / or narrowing of edges to improve release characteristics of the connector 922 from a pocket, for example the pocket 1130 of the retainer 1020 of the delivery catheter 200. In embodiments, the apex 942, the first and second midpoints 940A, 940B, and / or the transitions between the stem 924 and the first and fourth edges 926, 932, as shown in FIG.31, and / or transitions between an inner surface IS and an outer surface OS of the paddle 925 along the first, second, third, and / or fourth edges 926, 928, 930, 932, as shown in FIG. 32, may include filleting, in any combination. In embodiments shown in FIG. 32, the filleting of the edge between the inner surface IS and the outer surface OS of the paddle 925 may be such that a first depth DPI of the paddle 925 at the edges of the paddle 925 is greater than a second depth DP2 along the centerline CL2 of the paddle. The filleting of the connector 922 may be accomplished by various methods including, but not limited to sanding and grinding.

[0122] FIG. 33 is a side view of the retainer 1020 of the delivery catheter 200 with the connector 922 of the heart valve prosthesis 300 disposed therein. The stem 924 of the connector 922 is disposed within the opening 238 of the retainer 1020. With the outer sheath 202 (FIG. 1) of the delivery catheter 200 disposed over the retainer 1020 and the connector 922, the outer sheath 202 retains the connector 922 within the pocket 1130 of the retainer 1020 to releasably couple the heart valve prosthesis 300 to the delivery catheter 200. Each connector 922 is longitudinally, rotationally, and radially constrained within the pocket 1130 the by the first, second, proximal, and distal walls 1136A, 1136B, 1132, 1134 and the outer sheath 202.

[0123] FIGS. 34-35 show the connector 922 of the heart valve prosthesis 300 rotated within the pocket 230 of the retainer 1020, which may occur upon release from the delivery catheter 200, as previously described. The first edge 926 of the connector 922 is in contact with the first side wall 1136A of the pocket 1130. The straight or smooth edge of the first edge 926 and the smoothed transition between the stem 924 and the first edge 926 presents no surface to hang-up or catch on the smoothed first side wall 1136A and the smoothed transition between the first side wall 236A and the distal wall 1134 of the retainer 1020, thereby reducing or eliminating paddle / connector hang up and improving release of the heart valve prosthesis.

[0124] While described herein with the teardrop shaped pocket 1130 of the retainer 1020 and the diamond shaped connector 922, this is not meant limiting, and other shaped pockets and paddles may be combined with smoothed transitions to reduce or eliminate paddle / connector hang up and improving release of the heart valve prosthesis.

[0125] The embodiments described above describe a single pocket in the respective retainer and a single connector. It is understood, as described above, each of the retainersmay include a plurality of pockets and the heart valve prosthesis may include a corresponding plurality of connectors. Further, in some embodiments, the plurality of pockets may each have the same shape. However, this is not meant to be limiting, and in other embodiments, different pockets of a retainer may have different shapes. Similarly, in some embodiments, the plurality of connectors may have the same shape. However, this is not meant to be limiting, and in other embodiments, different connectors of the heart valve prosthesis may have different shapes. In some embodiments, the pockets may have different shapes and the connectors may each have a shape corresponding to the pocket in which the connector is to be disposed. Thus, the proper orientation of the heart valve prosthesis relative to the delivery system may be ensured.

[0126] While only some embodiments have been described herein, it should be understood that the embodiments have been presented by way of illustration and example only, and not limitation. Various changes in form and detail can be made therein without departing from the spirit and scope of the invention, and each feature of the embodiment discussed herein, and of each reference cited herein, can be used in combination with the features of any other embodiment. All patents and publications discussed herein are incorporated by reference herein in their entirety.

[0127] The following examples are illustrative of the techniques described herein.

[0128] Example 1. A retainer for a delivery catheter for delivering a heart valve prosthesis, the retainer comprising: a generally tubular body comprising a body portion including a body portion outer surface and a lumen extending through the body portion; and a pocket, wherein the pocket includes a pocket outer surface that is depressed with respect to the body portion outer surface towards a central longitudinal axis of the retainer, the pocket being defined by: a first side wall extending generally longitudinally; a second side wall extending generally longitudinally on an opposite side of a centerline of the pocket; a proximal wall extending from the first side wall to the second side wall; and a distal wall extending generally circumferentially from the second side wall towards the centerline; wherein there is no corresponding distal wall extending from the first side wall towards the centerline.

[0129] Example 2. The retainer of Example 1, wherein the pocket further comprises a distal opening between defined between the distal wall and a distal end of the first side wall.

[0130] Example 3. The retainer of Example 2, wherein the first side wall is spaced a first circumferential distance from the centerline and the second side wall is spaced a second circumferential distance from the centerline, wherein the first circumferential distance and the second circumferential distance are about equal.

[0131] Example 4. The retainer of any one of Examples 1 to 3, wherein the distal opening is asymmetric in that a first distance from the centerline the distal wall is shorter than a second distance from the centerline to the first wall.

[0132] Example 5. The retainer of any one of Examples 1 to 4, wherein the proximal wall is curved, and wherein an apex of the proximal wall is aligned with the centerline.

[0133] Example 6. The retainer of Example 1, wherein the pocket is generally a halfpaddle shape.

[0134] Example 7. The retainer of Example 1, wherein the centerline of the pocket is a centerline of a distal opening of the pocket, wherein the pocket is asymmetric with respect to the centerline.

[0135] Example 8. The retainer of Example 7, wherein the first side wall is spaced a first circumferential distance from the centerline and the second side wall is spaced a second circumferential distance from the centerline, wherein the first circumferential distance is shorter than the second circumferential distance.

[0136] Example 9. The retainer of Example 7 or Example 8, wherein the distal opening is symmetric with respect to the centerline in that a first distance from the centerline the distal wall is about equal to a second distance from the centerline to the first side wall.

[0137] Example 10. A retainer for a delivery catheter for delivering a heart valve prosthesis, the retainer comprising: a generally tubular body comprising a body portion including a body portion outer surface and a lumen extending through the body portion; and a pocket, wherein the pocket includes a pocket outer surface that is depressed with respect to the body portion outer surface towards a central longitudinal axis of the retainer, wherein the pocket is generally diamond-shaped.

[0138] Example 11. The retainer of Example 10, wherein the pocket is defined by: a first side wall extending proximally and away from a centerline of the pocket on a first side of the centerline at a first angle relative to the centerline; a second side wall extending proximally from a proximal end of the first side wall and towards the centerline at a secondangle relative to the centerline to an apex; a third side wall extending distally from the apex and away from the centerline on a second side of the centerline at a third angle; and a fourth side wall extending distally from a distal end of the third side wall and towards the centerline at a fourth angle.

[0139] Example 12. The retainer of Example 11, wherein the first angle, the second angle, the third angle, and the fourth angle are about equal.

[0140] Example 13. The retainer of Example 11 or Example 12, wherein each of the first angle, the second angle, the third angle, and the fourth angle is in a range of about 15° to about 75° or about 30° to about 60°.

[0141] Example 14. A heart valve prosthesis comprising: a frame having a first end, a second end, and a central lumen extending between the first end and the second end, the frame comprising a plurality of struts defining cells; a valve component disposed within and coupled to the frame; and a connector extending from the first end of the frame, the connector configured to couple the frame to a delivery system, the connector including a paddle, wherein the paddle is configured to release from the delivery system with minimal hang-up.

[0142] Example 15. The heart valve prosthesis of Example 14, wherein the connector further includes a stem coupling the paddle to the frame.

[0143] Example 16. The heart valve prosthesis of Example 15, wherein the paddle is asymmetric with respect a centerline of the stem.

[0144] Example 17. The heart valve prosthesis of any one of Examples 14to 16, wherein the connector is half-paddle shaped.

[0145] Example 18. The heart valve prosthesis of Example 17, wherein the paddle comprises a first edge extending generally longitudinally in a first direction on a first side of the centerline, a second edge extending from the first edge generally circumferentially from the first side of the centerline to a second side of the centerline, a third edge extending from the second edge generally longitudinally in a second direction opposite the first direction, and a fourth edge extending from the third edge towards the centerline.

[0146] Example 19. The heart valve prosthesis of Example 18, wherein the first edge is spaced a first circumferential distance from the centerline and the third edge is spaced asecond circumferential distance from the centerline, wherein the second circumferential distance is larger than the first circumferential distance.

[0147] Example 20. The heart valve prosthesis of Example 19, wherein the first edge comprises a longitudinal continuation of a first stem edge of the stem on the first side of the centerline and the third edge is spaced circumferentially from a second stem edge on the second side of the centerline by the fourth edge.

[0148] Example 21. The heart valve prosthesis of Example 14, wherein the paddle is generally diamond-shaped.

[0149] Example 22. The heart valve prosthesis of any one of Examples 14to 16, wherein the paddle comprises a first edge that is chamfered.

[0150] Example 23. The heartvalve prosthesis ofany one of Examples 14to 16, wherein the paddle comprises a first edge extending longitudinally and at a first angle away from the centerline in a first direction on a first side of the centerline, a second edge extending from the first edge generally circumferentially from the first side of the centerline to a second side of the centerline, a third edge extending from the second edge generally longitudinally in a second direction opposite the first direction, and a fourth edge extending from the third edge towards the centerline.

[0151] Example 24. The heart valve prosthesis of Example 23, wherein the first angle is in a range of about 15° to about 75° or about 30° to about 60°.

[0152] Example 25. A delivery system for delivering a heart valve prosthesis to a desired treatment location, the delivery system comprising: a delivery catheter including an inner shaft, an outer shaft, a middle member disposed radially between the inner shaft and the outer shaft, and a retainer coupled to a distal portion of the middle member, the retainer comprising a pocket; and a heart valve prosthesis including a frame, a valve component disposed within and coupled to the frame, and a connector extending from an end of the frame, wherein in a delivery configuration the connector of the frame is disposed in the pocket of the retainer to couple the heart valve prosthesis to the delivery catheter, and wherein the pocket and the connector are configured to prevent hang-up of the connector in the pocket such as to improve release of the connector from the pocket of the retainer.

[0153] Example 26. The delivery system of Example 25, wherein the retainer comprises the retainer of any one of Examples 1 to 13.

[0154] Example 27. The delivery system of Example 25 or 26, wherein the connector comprises the connector of the heart valve prosthesis of any one of Examples 14 to 24.

Claims

WHAT IS CLAIMED IS:

1. A retainer (520, 620, 820, 1020) for a delivery catheter for delivering a heart valve prosthesis, the retainer comprising: a generally tubular body comprising a body portion (227) including a body portion outer surface (229) and a lumen (220) extending through the body portion; and a pocket (230, 630, 830, 1130), wherein the pocket includes a pocket outer surface (231, 631, 1131) that is depressed with respect to the body portion outer surface towards a central longitudinal axis of the retainer, the pocket being configured to reduce hang up of a connector of a heart valve prosthesis during release of the heart valve prosthesis from the delivery catheter.

2. The retainer of claim 1, wherein the pocket is defined by: a first side wall (236A, 636A) extending generally longitudinally; a second side wall (236B, 636B) extending generally longitudinally on an opposite side of a centerline (CL1) of the pocket; a proximal wall (232, 632) extending from the first side wall to the second side wall; and a distal wall (534B, 634B) extending generally circumferentially from the second side wall towards the centerline; wherein there is no corresponding distal wall extending from the first side wall towards the centerline.

3. The retainer of claim 2, wherein the pocket further comprises a distal opening (538) between defined between the distal wall (534) and a distal end of the first side wall (538 A), wherein the first side wall is spaced a first circumferential distance from the centerline and the second side wall is spaced a second circumferential distance from the centerline, wherein the first circumferential distance and the second circumferential distance are about equal, and wherein the distal opening is asymmetric with respect to the centerline.

4. The retainer of claim 2 or claim 3, wherein the proximal wall (232, 632) is curved, and wherein an apex of the proximal wall is aligned with the centerline.

5. The retainer of claim 2, wherein the centerline (CL1) of the pocket is a centerline of a distal opening (538, 638) of the pocket, wherein the pocket is asymmetric with respect to the centerline.

6. The retainer of claim 5, wherein the first side wall (638 A) is spaced a first circumferential distance from the centerline (CL1) and the second side wall (638B) is spaced a second circumferential distance from the centerline (CL1), wherein the first circumferential distance is shorter than the second circumferential distance, and wherein the distal opening (638) is symmetric with respect to the centerline.

7. The retainer of claim 1, wherein the pocket (838) is generally diamond-shaped.

8. A heart valve prosthesis (300) comprising: a frame (302) having a first end, a second end, and a central lumen (312) extending between the first end and the second end, the frame comprising a plurality of struts (314) defining cells (316); a prosthetic valve (304) disposed within and coupled to the frame; and a connector (422, 722, 922) extending from the first end of the frame, the connector configured to couple the frame to a delivery system, the connector including a paddle (425, 725, 925), wherein the paddle is configured to release from the delivery system with minimal hang-up.

9. The heart valve prosthesis of claim 8, wherein the connector (422, 722) further includes a stem (424, 724) coupling the paddle (425, 725) to the frame, and wherein the paddle is asymmetric with respect to a centerline (CL2) of the stem.

10. The heart valve prosthesis of claim 8 or claim 9, wherein the paddle (425) is half-paddle shaped.

11. The heart valve prosthesis of claim 8, wherein the paddle (925) is generally diamond-shaped.

12. The heart valve prosthesis of any one of claims 8 to 11, wherein the paddle (922) comprises a first edge that is chamfered.

13. A delivery system (100) for delivering a heart valve prosthesis (300) to a desired treatment location, the delivery system comprising: a delivery catheter (200) including an inner shaft (208), an outer shaft (202), a middle member (206) disposed radially between the inner shaft and the outer shaft, and a retainer (520, 620, 820, 1020) coupled to a distal portion of the middle member, the retainer comprising a pocket (230, 630, 830, 1130); and a heart valve prosthesis (300) including a frame (302), a prosthetic valve (304) disposed within and coupled to the frame, and a connector (422, 722, 922) extending from an end of the frame, wherein in a delivery configuration the connector of the frame is disposed in the pocket of the retainer to couple the heart valve prosthesis to the delivery catheter, and wherein the pocket and the connector are configured to prevent hang-up of the connector in the pocket such as to improve release of the connector from the pocket of the retainer.

14. The delivery system of claim 13, wherein the retainer comprises the retainer of any one of claims 1 to 7.

15. The delivery system of claim 13 or 14, wherein the connector comprises the connector of the heart valve prosthesis of any one of claims 8 to 12.

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