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. In some embodiments, the connector and / or the pocket is teardrop shaped.

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 / 625,809, filed January 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 of the present application a retainer for a delivery system 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 teardrop shaped.

[0007] In another example hereof, in the retainer of any of the preceding or following examples, the pocket is defined by a first side wall, a second side wall disposed opposite the first side wall, and a curved wall, wherein the first side wall and the second side wall are each disposed at an angle with respect to a centerline of the pocket.

[0008] In another example hereof, in the retainer of any of the preceding or following examples, the angle is in a range of about 15° to about 75° or about 30° to about 60°.

[0009] In another example hereof, in the retainer of any of the preceding or following examples, the first side wall and the second side wall each extend from a respective first end to a respective second end, wherein each first end is disposed a first transverse distance from the centerline and each second end is disposed a second transverse distance from the centerline, wherein the second transverse distance is greater than the first transverse distance.

[0010] In another example hereof, in the retainer of any of the preceding or following examples, the second end of each of the first and second side walls is disposed proximally of each first end.

[0011] In another example hereof, in the retainer of any of the preceding or following examples, the curved wall extends from the second end of the first side wall in an arc and longitudinally away from the second end of the first side wall to an apex and in an arc and longitudinally towards the second end of the second side wall.

[0012] In another example hereof, in the retainer of any of the preceding or following examples, the curved wall is a proximal curved wall.

[0013] In another example hereof, in the retainer of any of the preceding or following examples, the pocket further comprises an opening longitudinally opposite the curved wall.

[0014] In another example hereof, in the retainer of any of the preceding or following examples, the opening is defined transversely between the first ends of the first and second side wall.

[0015] In another example hereof, in the retainer of any of the preceding or following examples, the retainer comprises a plurality of pockets.

[0016] In another example of the present application, a retainer for a delivery system 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 includes a ramp configured to prevent hang-up of a connector of the heart valve prosthesis in the pocket.

[0017] In another example hereof, in the retainer of any of the preceding or following examples, the pocket is defined by a first sidewall, a second sidewall, a proximal curved sidewall extending from the first sidewall, and a distal wall opposite the curved proximal wall.

[0018] In another example hereof, in the retainer of any of the preceding or following examples, the ramp comprises a first ramp adjacent the first sidewall and a second ramp adjacent the second sidewall, wherein the first ramp and the second ramp are disposed on opposite sides of a centerline of the pocket and a spaced by a distance.

[0019] In another example hereof, in the retainer of any of the preceding or following examples, the first ramp and the second ramp are inclined outwardly at an incline angle from the proximal curved wall to the distal wall.

[0020] In another example hereof, in the retainer of any of the preceding or following examples, the first ramp and the second ramp are inclined outwardly at an incline angle from a proximal end distal of the curved wall to the distal wall.

[0021] In another example hereof, in the retainer of any of the preceding or following examples, the incline angle is in the range of about 15° to about 75°.

[0022] In another example of the present application, 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, wherein the connector is teardrop shaped.

[0023] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the connector comprises a first side edge extending from a first end to a second end on a first side of a centerline of the connector, a second side edge extending from a first end to a second end on a second side of the connector, and a curved edge extending in an arc and longitudinally away from the second end of the first side edge to an apex at the centerline and from the apex in an arc and longitudinally towards the second end of the second side edge.

[0024] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the first side edge and the second side edge are each disposed at an angle with respect to the centerline.

[0025] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, wherein the angle is in a range of about 15° to about 75° or about 30° to about 60°.

[0026] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the heart valve prosthesis comprises a plurality of connectors.

[0027] In another example hereof, in the heart valve prosthesis of any of the preceding or following examples, the first end of the frame is an outflow end of the heart valve prosthesis.

[0028] In another example of the present application, a delivery system for delivering a heart valve prosthesis to a desired treatment location comprises: a delivery catheterincluding 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. 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.

[0029] In another example hereof, in the delivery system of any of the preceding or following examples, the retainer comprises any one of the retainers of the previous retainer examples.

[0030] In another example hereof, in the delivery system of any of the preceding or following examples, the connector comprises the connector of the heart valve prosthesis of any one of previous heart valve prosthesis examples.

[0031] In another example hereof, in the delivery system of any of the preceding or following examples, the retainer comprises a plurality of pockets and the heart valve prosthesis comprises a corresponding plurality of connectors.

[0032] 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

[0033] 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.

[0034] FIG. 1 depicts a side view illustration of a delivery system according to embodiments hereof.

[0035] FIG. 2 depicts a cross-sectional view taken along line A-A of FIG. 1.

[0036] FIG. 3 depicts a perspective view of a distal portion of the delivery system ofFIG. 1.

[0037] FIG. 4 depicts a side view illustration of a prior art retainer.

[0038] FIG. 5 depicts a side view illustration of a prior art heart valve prostheses.

[0039] FIG. 6 depicts an end view illustration of the heart valve prosthesis of FIG. 5.

[0040] FIG. 7 depicts a connector of the heart valve prosthesis of FIG. 5.

[0041] FIG. 8 depicts a side view illustration of a retainer according to embodiments hereof.

[0042] FIG. 9 depicts another side view illustration of the retainer of FIG. 8.

[0043] FIG. 10 depicts a side view illustration of a connector of a heart valve prosthesis disposed on the retainer of FIG. 8.

[0044] FIG. 11 depicts a side view illustration of the retainer of FIG. 8 in a recapture configuration.

[0045] FIG. 12 depicts a connector twisted in the pocket of the retainer of FIG. 8.

[0046] FIG. 13 depicts a side view illustration of a connector of a heart valve prosthesis according to embodiments hereof.

[0047] FIG. 14 depicts a side view illustration of the connector of FIG. 13 disposed on a retainer of a delivery system.

[0048] FIG. 15A depicts a side view illustration of the connector of FIG. 13 twisted in a pocket of a retainer.

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

[0050] FIG. 16 depicts a side view illustration of the retainer of FIG. 13 in a recapture configuration.

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

[0052] FIG. 18A depicts a side view illustration of the connector of FIG. 17 twisted in the pocket of the retainer of FIG. 17.

[0053] FIG. 18B depicts another side view illustration of the connector of FIG. 17 twisted in the pocket of the retainer of FIG. 17.

[0054] FIG. 19 depicts a side view illustration of the retainer and the connector FIG. 17 in a recapture configuration.

[0055] FIG. 20 depicts a perspective view illustration of a retainer according to embodiments hereof.

[0056] FIG. 21 depicts a side cross-sectional view of the retainer of FIG. 20.

[0057] FIG. 22A depicts a side view illustration of a connector of a heart valve prosthesis twisted within a pocket of the retainer of FIG. 20.

[0058] FIG. 22B depicts another side view illustration of a connector of a heart valve prosthesis twisted within a pocket of the retainer of FIG. 20.

[0059] FIG. 23 depicts a perspective view illustration of a retainer according to embodiments hereof.

[0060] FIG. 24 depicts a side cross-sectional view of the retainer of FIG. 23.

[0061] FIG. 25A depicts a side view illustration of a connector of a heart valve prosthesis twisted within a pocket of the retainer of FIG. 23.

[0062] FIG. 25B depicts another side view illustration of a connector of a heart valve prosthesis twisted within a pocket of the retainer of FIG. 23.DETAILED DESCRIPTION

[0063] 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.

[0064] 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.

[0065] 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.

[0066] 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-expanding materials 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.

[0067] 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.

[0068] 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.

[0069] 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 a plurality of connectors. 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 connectors from the pockets when deploying the heart valve prosthesis from the delivery catheter at the desired treatment location.

[0070] 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 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 atip 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 220 attached to a distal portion thereof for receiving tabs or connectors 322 of the heart valve prosthesis 300, as shown in FIG. 3.

[0071] 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 terminates within 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 inFIG. 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. The inner shaft 208 defines a lumen 211 configured to receive a guidewire GW as shown in FIG. 2.

[0072] 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 pocket 230 configured to receive a tab or connector 322 of the heart valve prosthesis 300. 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 236 extending between the proximal wall 232 and the distal wall 234. 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. The retainer 220 further includes a collar 244 the distal end 226 of the retainer 220. Only one pocket 230 is shown in FIG. 4, but the retainer 220 includes pockets 230 equal to the number of tabs or connectors 322 of the heart valve prosthesis 300.

[0073] 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.

[0074] 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 heartvalve 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.

[0075] 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.

[0076] 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. Each connector 322 extends from an endmost crown 318 of the heart valve prosthesis 300 and is connected by a stem 324. In embodiments herein, 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.

[0077] FIG. 7 illustrates a prior art connector 322 of the plurality of connectors 322. Each 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 thedelivery 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 perpendicular to a centerline CL of the connector 322. The second edge 328 distally extends from the first edge 326 and is generally parallel to the centerline CL of the connector 322. The fourth edge 332 distally extends from the fifth edge 334 and generally parallel to the centerline CL of the connector 322 such that the second edge 328 and the fourth edge 332 are equally spaced from the centerline CL 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.

[0078] An embodiment of a retainer 1120 of the present disclosure is illustrated in FIGS. 8-12. The retainer 1120 is a generally tubular component including a lumen 1122 extending from a proximal end 1124 to a distal end 1126 of the retainer 1120. The retainer 1120 may be coupled to the distal end 218 of the middle member 206 by various methods including, but not limited to, threaded engagement, adhesives, fusing, mechanical locks, friction fit, or any other method suitable for the purposes described herein. In embodiments herein, the retainer 1120 includes a proximal portion 1140, a body portion 1142, and a collar 1144. The proximal portion 1140 distally extends from the proximal end 1124, the body portion 1142 distally extends from the proximal portion 1140, and the collar 1144 distally extends from the body portion 1142.

[0079] FIG. 8 shows a side view of the retainer 1120 facing the pocket thereof. FIG. 9 shows a side view of the retainer 1120 with the retainer rotated 90 degrees from the view of FIG. 8, such that the pockets are facing up and down in FIG. 9. As shown in FIGS. 8-9, the proximal portion 1140 includes a flared outer surface 1146 distally extending from the proximal end 1124 of the retainer 1120 to a distal end 1148 of the proximal portion 1140. The body portion 1142 includes a cylindrical outer surface 1150 extending from a proximal end 1152 adjacent the distal end 1148 of the proximal portion 1140, to a distal end 1154. Although the outer surfaces of the proximal portion 1140 and the body portion 1142 have been described as flared and cylindrical, this is not meant to be limiting, and other shapes may be used. For example, and not by way of limitation, the outer surface of the body portion may continue flaring as a continuation of the outer surface of the proximal portion. In another example, and not by way of limitation, the outer surfaces of the proximal and body portions may both be cylindrical. The body portion 1140 further includes a pluralityof pockets 1130. Each pocket 1130 is depressed inwardly with respect to the outer surface 1150 of the body portion 1142 and includes an outer surface 1131. Stated another way, and as shown in the hidden lines of FIG. 9, a first radius R1 measured from the central longitudinal axis CLA of the retainer 1120 to the outer surface 1150 of the body portion 1142 is larger than a second radius R2 measured from the central longitudinal axis CLA to the outer surface 1131 of the pocket 1130, thereby forming the pocket 1130.

[0080] As shown in FIG. 8, each pocket 1130 of the retainer 1120 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. An opening 1138 of the pocket 1130 at the distal end 1154 of the body portion 1142 enables a stem 324 of a connector 322 of the heart valve prosthesis 300 to extend there through. Each pocket 1130 of the retainer 1120 is configured to receive a corresponding 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 proximal wall 1132 of the pocket extends proximally and circumferentially in an arc from a first end 1158 to an apex 1160, and then distally and circumferentially in an arc to a second end 1162. Thus, the apex 1160 is disposed proximally of the first and second ends 1158, 1162 of the proximal wall 1132. Further, the apex 1160 is disposed a distance DI from the proximal end of the retainer 1120. The first side wall 1136A is indicated by an extended line SW1 and extends distally from the first end 1158 of the proximal wall 1132 to the distal end 1154 of the body portion 1142. Similarly, the second side wall 1136B is indicated by an extended line SW2 and extends distally from the second end 1162 of the proximal wall 1132 to the distal end 1154 of the body portion 1142. The distal ends of the first sidewall 1136A and the second sidewall 113B are laterally separated by a distance D2, which defines the opening 1138 of the pocket 1130. The first and second side walls 1136A, 1136B each extend from the opening 1138 at an angle 61 from a centerline CL of the pocket 1130 on opposite sides of the centerline CL. In embodiments herein, the angle 01 may be between about 15° to about 75° or about 30° to about 60°. Notably, in the embodiment of FIGS. 8-9, there is no wall that extends transversely into the pocket. In other words, there is no distal end wall extending transversely to the centerline CL, such as the distal wall 234 of the prior art embodiment shown above.

[0081] FIG. 10 illustrates the pocket 1130 of the retainer 1120 with the prior art connector 322 of the heart valve prosthesis 300 disposed therein. In embodiments herein, the first side wall 1136A and the second side wall 1136B of the pocket 1130, as indicated by the extended lines SW1, SW2, respectively, present no perpendicular or parallel surfaces relative to the first edge 326 of the connector 322 as indicated by an extended line El, the second edge 328 as indicated by an extended line E2, the fourth edge 332 as indicated by an extended line E3, and the fifth edge 334 as indicated by the extended line El. As shown in FIG. 10, an angle 02 between the second edge 328 of the connector 322 and the first side wall 1136A of the pocket 1130, and the fourth edge 332 of the connector 322 and the second side wall 1136B of the pocket 1130 are each less than 90o. In similar fashion, an angle 03 between the first edge 326 of the connector 322 and the first side wall 1136A of the pocket 1130, and the fifth edge 334 of the connector 322 and the second side wall 1136B of the pocket 1130 are each less than 90o. Thus, if the first edge 326 and / or the second edge of the connector 322 contacts the first side wall 1136A of the pocket 1130, or if the fourth edge 332 and / or the fifth edge 334 of the connector 322 contacts the second side wall 1136B of the pocket 1130, the contact area CA2 is line of contact. In embodiments herein, the angle 02 and the angle 03 may each be between about 15° to about 75° or about 30° to about 60°.

[0082] As also shown in FIG. 10, each connector 322 sits loosely in the corresponding pocket 1130. In other words, the connector 322 sits in a proximal portion of the pocket 1130 such that the edges of the connector 322 do not contact the sidewalls 1136A. 1136B of the pocket 1130. When the heart valve prosthesis 300 is being deployed from the capsule 216 of the delivery catheter 200, the capsule 216 is withdrawn proximally. Thus, friction between the capsule 216 and the heart valve prosthesis 300 tends to push the heart valve prosthesis 300 proximally. The proximal wall 1132 of the retainer 1120 prevents the heart valve prosthesis 300 from excessive proximal translation. Further, because the connector 322 is sitting in the proximal portion of the pocket 1130, the connector 322 will tend to release easily from the retainer 1120 when the capsule 216 is retracted.

[0083] If there is a need to recapture the heart valve prosthesis 300 during deployment, the capsule 216 is advanced distally over a partially deployed heart valve prosthesis 300 to transition the heart valve prosthesis 300 from a partially expanded configuration to the radially compressed configuration and accordingly recapture the heart valve prosthesis 300within the capsule 216 of the delivery catheter 200. This distal advancement creates a friction force on the heart valve prosthesis 300 in the distal direction. The pocket 1130 is configured to prevent the heart valve prosthesis 300 from being displaced distally during such a recapture procedure. In particular as shown in FIG. 11, during a recapture, the connector 322 slides slightly distally until the sidewalls 1136A, 1136B prevent further distal movement. Thus, movement of the heart valve prosthesis 300 in the distal direction is halted when the connector 322 contacts the first and second side walls 1136A, 1136B.

[0084] As discussed briefly above, during delivery and deployment, the heart valve prosthesis 300 may be subject to rotation forces, twisting, and torquing. In some circumstances, this may cause the connector 322 to twist, as shown in FIG. 12. However, as shown in FIG. 12, the teardrop shape of the pocket 1130 prevents or reduces the likelihood of the connector 322 to hang-up in the pocket 1130. In particular, with the connector 322 twisted as shown in FIG. 12, the connector can slide along the sidewall 1136A of the pocket 1130 until the connector 322 exits the pocket 1130. In particular, in the example of FIG. 12, the connector 322 has rotated rotate within the pocket 1130 such that the j unction of the first edge 326 and the second edge 328 of the connector 322 contact the first side wall 1136A of the pocket 1130. However, due to the teardrop shape of the pocket 1130 with the angled sidewalls 1136A, 1136B and no distal end wall, the contact angle between the connector 322 and the first sidewall 1136A is less than 90o, and the connector 322 will slide along the first sidewall 1136A. While FIG. 12 illustrates the junction of the first edge 326 and the second edge 328 of the connector 322 in contact with the first side wall 1136A of the pocket 1130, it will be recognized that the junction of the fourth edge 332 and the fifth edge 334 will present a similar reduced contact area.

[0085] FIGS. 13-16 show a connector 1622 of the heart valve prosthesis 300 according to embodiments hereof. The connector 1622 can be used with the heart valve prosthesis 300 described above or other heart valve prostheses, as explained above. FIGS. 13-16 show one connector 1622. However, as described above, the heart valve prosthesis 300 may include more connectors 1622, such as two connectors 1622, or three connectors 1622, or four connectors 1622, or more than four connectors 1622.

[0086] The connector 1622 of FIGS. 13-16 is generally teardrop shaped. Thus, in a nonlimiting example, each connector 1622 extends from an endmost crown 318 of the frame302. Each connector 1622 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. Each connector 1622 includes a general teardrop shape defined by a proximal edge 1627, a first side edge 1629, a second side edge 1633, and a distal edge 1631.

[0087] The proximal edge 1627 of the connector 1622 is disposed adjacent an endmost crown 318 of the frame 302 of the heart valve prosthesis 1600 and extends circumferentially from a first end 1646 at the first side edge 1629 to a second end 1648 at the second side edge 1633. However, although described herein as a proximal “edge,” this is not meant to be limiting. In some embodiments, the connection 1622 may be an extension of the frame 302 of the heart valve prosthesis 300, in which case there would not be a defined proximal “edge.” For example, and not by way of limitation, a frame 302 that is laser cut from a tube may have a unitary (i.e., made from a single piece, undivided, whole) frame 302 including the connectors 1622. Thus, description of the proximal edge 1627 is for ease of describing the connector 1622.

[0088] The first side edge 1629 as indicated by an extended line SEI extends distally at an angle 04 from a centerline CL of the connector 1622 from the first end 1646 of the proximal edge 1627 to a first end 1640 of the distal edge 1631. The second side edge 1633 as indicated by an extended line SE2 extends distally at the angle 04 on an opposite side of the centerline CL of the connector 1622 from the second end 1648 of the proximal edge 1627 to a second end 1644 of the distal edge 1631. In embodiments herein, the angle 04 may be between about 15° to about 75° or about 30° to about 60°. The first and second ends 1646, 1648 of the proximal edge 1627, and hence the first ends of the first and second side edges 1629, 1633, are each displaced a distance D3 from the centerline CL on opposite sides of the centerline CL. However, this is not meant to be limiting as the proximal edge 1627 and the endmost crown 318 may be formed unitarily, as described above.

[0089] The distal edge 1631 of the connector 1622 extends distally and circumferentially in an arc from the first end 1640 thereof to an apex 1642, and then proximally and circumferentially in an arc to the second end 1644 thereof, as shown in FIG. 13. Thus, the apex 1642 is disposed distally of the first and second ends 1640, 1644 of the distal edge 1631. The first and second ends 1640, 1644 of the distal edge 1631, and hence the second ends of the first and second side edges 1629, 1633 are displaced a distance D4from the centerline CL on opposite sides of the centerline CL. The distance D4 is greater than the distance D3 due to the angle 04 of each of the first and second side edges 1629, 1633.

[0090] FIG. 14 illustrates the connector 1622 disposed within the corresponding pocket 230 of the prior art retainer 220 of the delivery catheter 200. As illustrated in FIG. 14, the first side wall 236A of the pocket 230 is illustrated by the extended line SW1, the second side wall 236B of the pocket 230 is illustrated by the extended line SW2, and the distal wall 234 of the pocket 230 is illustrated by the extended line DW3. The first side edge 1629 of the connector 1622 as indicated by an extended line SEI and the second side edge 1633 of the connector 1622 as indicated by the extended line SE2 present no parallel or perpendicular surface to the walls of the pocket 230. As shown in FIG. 14, an angle 06 between the first side edge 1629 of the connector 1622 and the first side wall 236A of the pocket 230 or the second side edge 1633 of the connector 1622 and the second side wall 236B of the pocket 230 is each less than 90o. An angle 05 between the first side edge 1629 of the connector 1622 and the distal wall 234 of the pocket 230 or the second side edge 1633 of the connector 1622 and the distal wall 234 of the pocket 230 is each less than 90o. In embodiments herein, the angle 05 and 06 may be between about 15° to about 75° or about 30° to about 60°.

[0091] Referring to FIGS. 15A and 15B, in a non-limiting example, the connector 1622 of the heart valve prosthesis 300 is rotated within the pocket 230 of the retainer 220 when released by the delivery catheter 200 by rotational forces previously described. The first side edge 1629 of the connector 1622 is in contact with the distal wall 234 of the pocket 230 of the retainer 220. Due to the teardrop shape of the connector 1622, the angle of contact between the first side edge 1629 and the distal wall 234 of the pocket 230 is less than 90o. In other words, the teardrop shape of the connector 1622 does not present an edge that can get caught on a wall of the pocket 230, such as the proximal edges (first and fifth edges 326, 334) of the connector 322. Thus, as shown in FIG. 15B, if the connector 1622 is rotated within the pocket 230, the first side edge 1629 will not get caught on the distal wall 234 of the pocket 230. Instead, due to the angled first side edge 1629, the first side edge 1629 will ride up the distal wall 234 as escape the pocket 230, thereby reducing or eliminating paddle / connector hang up and improving release of the heart valve prosthesis. While FIGS.15A and 15B illustrate the first edge 1629 of the connector 1622 in contact with the distal wall 234 of the pocket 230 of the retainer 220, this is but one non-limiting example. In other non-limiting examples, the first side edge 1629 of the connector 1622 may contact the first side wall 236A of the pocket 230, or the second side edge 1633 of the connector may contact the second side wall 236B or the distal wall 234 of the pocket 230, and / or such situations may occur in any combination.

[0092] FIG. 16 illustrates the recapture of the heart valve prosthesis 300 with the connectors 1622. As previously described, if there is a need to recapture the heart valve prosthesis 300 during deployment, the capsule 216 is advanced distally over a partially deployed heart valve prosthesis 300 to transition the heart valve prosthesis 300 from a partially expanded configuration to the radially compressed configuration and accordingly recapture the heart valve prosthesis 300 within the capsule 216 of the delivery catheter 200. This distal advancement creates a friction force on the heart valve prosthesis 300 in the distal direction (proximal direction of the heart valve prosthesis 300). With this force, if the heart valve prosthesis 300 begins to move in the distal direction, the first and second side edges 1629, 1633 engage the distal wall 234 of the pocket 230, thereby preventing the heart valve prosthesis 300 from being displaced distally during such a recapture procedure. Thus, movement of the heart valve prosthesis 300 in the distal direction is halted when the connectors 1622 contact the distal wall 234.

[0093] FIGS. 17-19 show a portion of a delivery system including a delivery catheter 200 with a heart valve prosthesis 300, according to embodiments hereof. The delivery catheter 200 includes the retainer 1120 of FIGS. 8-9 with a plurality of pockets 1130 and the heart valve prosthesis 300 includes a corresponding number of teardrop shaped connectors 1622 as previously described with respect to FIG. 13. Therefore, all of the details described above with respect to the retainer 1120 and the connectors 1622 are incorporated into the description of FIGS. 20-21B and the same reference numerals are used.

[0094] FIG. 17 illustrates the connector 1622 disposed within the corresponding pocket 1130 of the retainer 1120 of the delivery catheter 200. As described above, the sidewalls of the pocket 1130 and the side edges of the connector are disposed at angles with respect to centerlines CL1, CL2 thereof. As described above, the angles may be in the range of about 15° to about 75° or about 30° to about 60°. However, in preferred embodiments hereof, theangles of the sidewalls 1136A, 1136B of pocket 1130 are not equal to the angles of the side edges 1629, 1633 of the connector 1622 when the side edges 1629, 1633 of the connector 1622 are engage with the sidewalls 136A, 1136B of the pocket 1130, as shown in FIG. 19. Thus, as explained below, the engagement shown in FIG. 19 is not preferable. Instead, when the angles of the sidewalls 1136A, 1136B and the angles of the side edges 1629, 1633 are different with the sidewalls and side edges in in contact, the connector 1622 presents no parallel or perpendicular surface to the walls of the pocket 1130 of the retainer 1120. Preferably, the angle between the side edges of the connector and the walls of the pocket when they are in contact with each other may be in the range of about 5° to about 45°.

[0095] FIGS. 18A and 18B illustrate a non-limiting example of the connector 1622 of the heart valve prosthesis 300 rotated within the pocket 1130 of the retainer 1120. Rotation of the connector 1622 of the heart valve prosthesis 300 within the pocket 1130 of the retainer 1120 may occur upon release of the heart valve prosthesis 300 due to rotational forces previously described. In FIGS. 15A and 15B, the second side edge 1633 of the connector 1622 of the heart valve prosthesis 300 is in contact with the second side wall 1136B of the pocket 1130 of the retainer 1120. As explained above, due to the teardrop shape of the connector 1622, the angle of contact between the second side edge 1633 and the second sidewall 1136B of the pocket 1130 is less than 90o. In other words, the teardrop shape of the connector 1622 does not present an edge that can get caught on the sidewall 1136B of the pocket 1130. Thus, as shown in FIG. 18B, if the connector 1622 is rotated within the pocket 1130, the second side edge 1633 of the connector 1622 will not get caught on the second sidewall 1136B of the pocket 1130. Instead, due to the angled second side edge 1633, the second side edge 1633 will ride up the second sidewall 1136B or slide along the inside of the second sidewall 1136B until the connector 1622 exits the pocket 1130, thereby reducing or eliminating paddle / connector hang up and improving release of the heart valve prosthesis. While FIGS. 18A and 18B illustrate the second side edge 1633 of the connector 1622 in contact with the second sidewall 1136B of the pocket 1130 of the retainer 1120, this is but one non-limiting example. In other non-limiting examples, the second side edge 1633 of the connector 1622 may contact the first side wall 1136A of the pocket 1130, or the first side edge 1629 of the connector 1622 may contact the first or second sidewalls 1136A, 136B of the pocket 1130, and / or such situations may occur in any combination.

[0096] FIG. 19 illustrates the recapture of the heart valve prosthesis 300 with the connectors 1622 with the delivery catheter 200 having the retainer 1120. As previously described, if there is a need to recapture the heart valve prosthesis 300 during deployment, the capsule 216 is advanced distally over a partially deployed heart valve prosthesis 300 to transition the heart valve prosthesis 300 from a partially expanded configuration to the radially compressed configuration and accordingly recapture the heart valve prosthesis 300 within the capsule 216 of the delivery catheter 200. This distal advancement creates a friction force on the heart valve prosthesis 300 in the distal direction (proximal direction of the heart valve prosthesis 300). With this force, if the heart valve prosthesis 300 begins to move in the distal direction, the first and second side edges 1629, 1633 of the connector 1622 engage the first and second sidewalls 1136A, 1136B of the pocket 1130, thereby preventing the heart valve prosthesis 300 from being displaced distally during such a recapture procedure. Thus, movement of the heart valve prosthesis 300 in the distal direction is halted when the connectors 1622 contact the sidewalls 1136A, 1136B of the pockets 1130. Although FIG. 19 shows the first and second side edges 1629, 1633 of the connector 1622 having approximately the same angle as the first and second sidewalls 1136A, 1136B of the pocket 1130, as explained above this is not preferable because in the condition of FIG. 19, the connector 1622 may be wedged within the pocket 11130 and not release properly when the capsule 216 is retracted. However, using different angles as explained above, there is less contact area between the first and second side edges 1629, 1633 and the first and second sidewalls 1136A, 1136B, thereby reducing the risk of the connector 1622 being wedged within the pocket 1130, and improving release of the heart valve prosthesis.

[0097] FIGS. 20-22B show a retainer 2320 according to another embodiment hereof. The retainer 2320 is the same as the retainer 220 shown in FIGS. 4 except as described herein. Therefore, all of the details described above are incorporated into the description of FIGS. 20-22B and the same reference numerals are used. Thus, generally, as described above, the retainer 2320 includes the proximal end 224, the distal end 226, the lumen 222, and the collar 244. The retainer 2320 further includes a pocket 2330 similar to the pocket 230. However, the pocket 2330 of the retainer 2320 of FIGS. 20-22B further includes at least one ramp 2370 disposed within the pocket 2330 of the retainer 2320.

[0098] In a non-limiting embodiment, each pocket 2330 includes a first ramp 2370A and a second ramp 2370B disposed on opposite circumferential or lateral sides of the centerline CL of the pocket 230. The first and second ramps 2370A, 2370B are configured to reduce or eliminate hang up or binding of the connector 322 within the pocket 2330 of the retainer 2320, thereby improving release probability of the heart valve prosthesis 300 from the retainer 2320 at a desired treatment location.

[0099] In an embodiment, the first ramp 2370A includes an outer wall 2373A disposed adjacent the first side wall 236A of the pocket 2330 and an inner wall 2374A disposed closer to the centerline CL than the outer wall 2373A is to the centerline CL. Further, the inner wall 2374A is spaced a distance D4 from the centerline CL of the pocket. The distance D4 may preferably be in the range of about 0.25mm to about 1.5mm. The first ramp 2370A further includes a radially outer surface 2372A (relative to the central longitudinal axis CLA of the retainer 2320). The outer surface 2372A of the first ramp 2370A ramps outwardly from a first end 2377A adjacent the proximal wall 232 of the pocket 2330 to a second end 2378A adjacent the distal wall 234 of the pocket 2330. In other words, the first ramp 2370A ramps radially outwardly from the proximal wall 232 to the distal wall 234 of the pocket 2330.

[0100] Similarly, the second ramp 2370B includes an outer wall 2373B disposed adjacent the second side wall 236B of the pocket 2330 and an inner wall 2374B disposed closer to the centerline CL than the outer wall 2373B is to the centerline CL. Further, the inner wall 2374B is spaced a distance D4 from the centerline CL of the pocket, which, as described above, may preferably be in the range of about 0.25mm to about 1.5mm. The second ramp 2370B further includes a radially outer surface 2372B (relative to the central longitudinal axis CLA of the retainer 2320). The outer surface 2372B of the second ramp 2370B ramps outwardly from a first end 2377B adjacent the proximal wall 232 of the pocket 2330 to a second end 2378B adjacent the distal wall 234 of the pocket 2330. In other words, the second ramp 2370B ramps radially outwardly from the proximal wall 232 to the distal wall 234 of the pocket 2330.

[0101] In a non-limiting embodiment, the first ends illK,of the outer surfaces 2372A, 2372B of the first and second ramps 2370A, 2370B are at the level of the outer surface 231 of the pocket 2330. In other words, at the first ends 2377A, 2377B, a radiusfrom the central longitudinal axis CLA to each of the outer surfaces 2372A, 2372B of the ramps 2370A, 2370B is approximately equal to the radius R1 from the central longitudinal axis CLA to the outer surface 231 of the pocket 2330. Further, the second ends 2378A, 2378B of the outer surfaces 2372A, 2372B of the first and second ramps 2370A, 2370B are at the level of the distal wall 234 of the pocket 2330. In other words, at the second ends 2378 A, 2378B, a radius from the central longitudinal axis CLA to each of the outer surfaces 2372A, 2372B of the ramps 2370A, 2370B is approximately equal to the radius R2 from the central longitudinal axis CLA to the outer surface of the distal wall 234 of the pocket 2330. However, this is not meant to be limiting.

[0102] With the ramps 2370A, 2370B as described above, each ramp 2370A, 2370B is disposed at an incline angle 06 with respect to the central longitudinal axis CLA of the retainer 2320. In embodiments, the incline angle 06 may be in the range of about 15° to about 75°. While the first ramp 2370A and the second ramp 2370B have been described herein with the same incline angle 06, this is not meant to be limiting, and the incline angle of the first ramp 2370A and the incline angle of the second ramp 2370B may not be equal.

[0103] FIGS. 22A and 22B illustrate anon-limiting example of the connector 322 of the heart valve prosthesis 300 rotated within the pocket 2330 of the retainer 2320. Rotation of the connector 322 of the heart valve prosthesis 300 within the pocket 2330 of the retainer 2320 may occur upon release of the heart valve prosthesis 300 due to rotational forces previously described. In FIGS. 22A and 22B, the second edge 328 of the connector 322 of the heart valve prosthesis 300 is in contact with the first ramp 2370A of the retainer 2320. However, as can best be seen in FIG. 22B, no edge of the connector 322 encounters a surface or wall of the pocket 2330 that will catch or restrain the connector 322, thereby reducing or eliminating paddle / connector hang up and improving release of the heart valve prosthesis. In particular, the first edge 326 of the connector 322 will not be impeded by the distal wall 234 of the pocket 2330. Instead, the connector 322 rides radially outwardly along the first ramp 2370A to exit the pocket 2330. Similarly, the connector 322 could slide along the inner wall 2374A of the first ramp 2370A to exit through the opening 238. While FIGS. 22A and 22B illustrate the second edge 328 of the connector 322 in contact with the first ramp 2370A, this is but one non-limiting example. In other non-limiting examples, the second edge 328 of the connector 322 may contact the second ramp 2370B of the pocket 2330, or the fourthedge 332 of the connector 322 may contact the first or second ramps 2370A, 2370B or the area between the first and second ramps 2370A, 2370B, and / or such situations may occur in any combination.

[0104] In embodiments herein, to recapture a heart valve prosthesis 300 during deployment, the capsule 216 of the delivery catheter 200 is advanced distally over the partially deployed heart valve prosthesis 300 to transition the heart valve prosthesis 300 from a partially expanded configuration to the radially compressed configuration and accordingly recapture the heart valve prosthesis 300 within the capsule 216 of the delivery catheter 200. This distal advancement of the capsule 216 creates a friction force on the heart valve prosthesis 300 in the distal direction, and each connector 322 of the heart valve prosthesis 300 will attempt to move distally, riding up the incline of the corresponding ramps 2370 of retainer 2320. The delivery catheter 200 is configured such that a clearance or distance between an inner surface of the capsule 216 and the outer surface of the retainer 2320 is small or narrow enough that the connectors 322 of the heart valve prosthesis 300 may not pass between the inner surface of the capsule 216 and the outer surface of the retainer 2320. Thus, movement of the heart valve prosthesis 300 in the distal direction is halted when the connector 322 contacts or is sandwiched between the inner surface of the capsule 216 and the outer surface 2372 of the corresponding ramps 2370 of the pocket 2330.

[0105] While the retainer 2320 is described in FIGS. 20-22B with the first and second ramps 2370A, 2370B each extending from the proximal wall 232 of the pocket 2330 to the distal wall 234 of the pocket 2330, this is not meant to be limiting. In another non-limiting embodiment, the retainer 2320 includes a first ramp 2370A’ and a second ramp 2370B’ each longitudinally extend over a longitudinal portion of the pocket 2330, as shown in FIGS. 23- 25B. The first ramp 2370A’ includes an outer wall 2373A’ disposed adjacent the first side wall 236A of the pocket 2330 and an inner wall 2374A disposed closer to the centerline CL than the outer wall 2373A is to the centerline CL. The inner wall 2374A is spaced a distance D5 from the centerline CL of the pocket. The distance D5 may preferably be in a range of about 0.25mm to about 1.5mm. An outer surface 2372A’ of the first ramp 2370A’ ramps outwardly from a first end 2377A’ located distal of the proximal wall 232 of the pocket 2330 to a second end 2378A’ adjacent the distal wall 234 of the pocket 2330.

[0106] The second ramp 2370B’ includes an outer wall 2373B’ disposed adjacent the second side wall 236B of the pocket 2330 and an inner wall 2374B’ disposed closer to the centerline CL than the outer wall 2373B is to the centerline CL and spaced a distance D5 from the centerline CL of the pocket. The outer surface 2372B’ of the second ramp 2370B’ ramps outwardly from a first end 2377B’ located distal of the proximal wall 232 of the pocket 2330 to a second end 2378B’ adjacent the distal wall 234 of the pocket 2330. Each ramp 2370A’, 2370B’ is disposed at an incline angle 07 with respect to the central longitudinal axis CLA of the retainer 2320. In embodiments, the incline angle 07 may be in a range of about 15° to about 75°.

[0107] In the embodiments shown in FIGS. 20-22B and FIGS. 23-25B, the ramps are shown in a pocket such as the pocket 230 with sidewalls generally parallel to the central longitudinal axis. However, this is not meant to be limiting, and ramps may also be used with the embodiments having a teardrop shaped pocket such as the pocket 1130 of FIG. 8.

[0108] 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.

[0109] The following examples are illustrative of the techniques described herein.

[0110] Example 1. A retainer for a delivery system 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 teardrop shaped.

[0111] Example 2. The retainer of Example 1, wherein the pocket is defined by a first side wall, a second side wall disposed opposite the first side wall, and a curved wall, wherein the first side wall and the second side wall are each disposed at an angle with respect to a centerline of the pocket.

[0112] Example 3. The retainer of Example 2, wherein the angle is in a range of about 15° to about 75° or about 30° to about 60°.

[0113] Example 4. The retainer of Example 2 or Example 3, wherein the first side wall and the second side wall each extend from a respective first end to a respective second end, wherein each first end is disposed a first transverse distance from the centerline and each second end is disposed a second transverse distance from the centerline, wherein the second transverse distance is greater than the first transverse distance.

[0114] Example 5. The retainer of Example 4, wherein the second end of each of the first and second side walls is disposed proximally of each first end.

[0115] Example 6. The retainer of any one of Examples 2 to 5, wherein the curved wall extends from the second end of the first side wall in an arc and longitudinally away from the second end of the first side wall to an apex and in an arc and longitudinally towards the second end of the second side wall.

[0116] Example 7. The retainer of any one of Examples 2 to 6, wherein the curved wall is a proximal curved wall.

[0117] Example 8. The retainer of any one of Examples 2 to 7, wherein the pocket further comprises an opening longitudinally opposite the curved wall.

[0118] Example 9. The retainer of Example 8, wherein the opening is defined transversely between the first ends of the first and second sidewall.

[0119] Example 10. The retainer of any one of Examples 1 to 9, wherein the retainer comprises a plurality of pockets.

[0120] Example 11. A retainer for a delivery system 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 includes a ramp configured to prevent hang-up of a connector of the heart valve prosthesis in the pocket.

[0121] Example 12. The retainer of Example 11, wherein the pocket is defined by a first sidewall, a second sidewall, a proximal curved sidewall extending from the first sidewall, and a distal wall opposite the curved proximal wall.

[0122] Example 13. The retainer of Example 12, wherein the ramp comprises a first ramp adjacent the first sidewall and a second ramp adjacent the second sidewall, wherein the first ramp and the second ramp are disposed on opposite sides of a centerline of the pocket and a spaced by a distance.

[0123] Example 14. The retainer of Example 12 or Example 13, wherein the first ramp and the second ramp are inclined outwardly at an incline angle from the proximal curved wall to the distal wall.

[0124] Example 15. The retainer of Example 12 or Example 13, wherein the first ramp and the second ramp are inclined outwardly at an incline angle from a proximal end distal of the curved wall to the distal wall.

[0125] Example 16. The retainer of Example 14 or Example 15, wherein the incline angle is in the range of about 15° to about 75°.

[0126] Example 17. A heart valve prosthesis comprising:

[0127] 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, wherein the connector is teardrop shaped.

[0128] Example 18. The heart valve prosthesis of Example 17, wherein the connector comprises a first side edge extending from a first end to a second end on a first side of a centerline of the connector, a second side edge extending from a first end to a second end on a second side of the connector, and a curved edge extending in an arc and longitudinally away from the second end of the first side edge to an apex at the centerline and from the apex in an arc and longitudinally towards the second end of the second side edge.

[0129] Example 19. The heart valve prosthesis of Example 18, wherein the first side edge and the second side edge are each disposed at an angle with respect to the centerline.

[0130] Example 20. The heart valve prosthesis of Example 19, wherein the angle is in a range of about 15° to about 75° or about 30° to about 60°.

[0131] Example 21. The heart valve prosthesis of any one of Examples 17 to 20, wherein the heart valve prosthesis comprises a plurality of connectors.

[0132] Example 22. The heart valve prosthesis of any one of Examples 17 to 21, wherein the first end of the frame is an outflow end of the heart valve prosthesis.

[0133] Example 23. 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 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.

[0134] Example 24. The delivery system of Example 23, wherein the retainer comprises any one of the retainers of Examples 1 to 16.

[0135] Example 25. The delivery system of Example 23, wherein the connector comprises the connector of the heart valve prosthesis of any one of Examples 17 to 22.

[0136] Example 26. The delivery system of any one of Examples 23 to 25, wherein the retainer comprises a plurality of pockets and the heart valve prosthesis comprises a corresponding plurality of connectors.

Claims

WHAT IS CLAIMED IS:

1. 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 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.

2. The delivery system of claim 1, wherein the retainer comprises a generally tubular body comprising a body portion including a body portion outer surface and a lumen extending through the body portion, 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 teardrop shaped.

3. The delivery system of claim 2, wherein the pocket is defined by a first side wall, a second side wall disposed opposite the first side wall, and a curved wall, wherein the first side wall and the second side wall are each disposed at an angle with respect to a centerline of the pocket.

4. The delivery system of claim 3, wherein the angle is in a range of about 15° to about 75° or about 30° to about 60°.

5. The delivery system of any claim 3 or claim 4, wherein the pocket further comprises an opening longitudinally opposite the curved wall.

6. The delivery system of any one of claims 1 to 5, wherein the retainer comprises a plurality of pockets.

7. The delivery system of claim 1, wherein the retainer comprises a generally tubular body comprising a body portion including a body portion outer surface and a lumen extending through the body portion, 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 includes a ramp configured to prevent hang-up of the connector of the heart valve prosthesis in the pocket.

8. The delivery system of claim 7, wherein: the pocket is defined by a first sidewall, a second sidewall, a proximal curved sidewall extending from the first sidewall, and a distal wall opposite the curved proximal wall; and the ramp comprises a first ramp adjacent the first sidewall and a second ramp adjacent the second sidewall, wherein the first ramp and the second ramp are disposed on opposite sides of a centerline of the pocket and a spaced by a distance.

9. The delivery system of claim 7 or claim 8, wherein the first ramp and the second ramp are inclined outwardly at an incline angle from the proximal curved wall to the distal wall, or from a proximal end distal of the proximal curved wall to the distal wall.

10. The delivery system of claim 9, wherein the incline angle is in the range of about 15° to about 75°.

11. The delivery system of claim 1, wherein the connector is teardrop shaped.

12. The delivery system of claim 11, wherein the connector comprises a first side edge extending from a first end to a second end on a first side of a centerline of the connector, a second side edge extending from a first end to a second end on a second side of the connector, and a curved edge extending in an arc and longitudinally away from the second end of the first side edge to an apex at the centerline and from the apex in an arc and longitudinally towards the second end of the second side edge.

13. The delivery system of claim 12, wherein the first side edge and the second side edge are each disposed at an angle with respect to the centerline.

14. The delivery system of claim 13, wherein the angle is in a range of about 15° to about 75° or about 30° to about 60°.

15. The delivery system of any one of claims 11 to 14, wherein the heart valve prosthesis comprises a plurality of connectors.

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