Retainer for a transcatheter valve delivery system

Abstract

A retainer for a delivery system for delivering a heart valve prosthesis includes a generally tubular body a lumen extending longitudinally through the body. The body includes a proximal portion, a distal portion, and a body portion extending between the proximal portion and the distal portion. The body portion is recessed as compared to the proximal portion and the distal portion such that a proximal shoulder is defined at a proximal end of the body portion and a distal shoulder is defined at a distal end of the body portion. The body portion is configured to receive a connector of the heart valve prosthesis. The body portion is pocketless.

Description

RETAINER FORA TRANSCATHETER VALVE DELIVERY SYSTEMCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 625,754, filed January 26, 2024, and U.S. Provisional Patent Application Serial No. 63 / 675,760, filed July 26, 2024, the entire contents of which are incorporated herein by reference.FIELD

[0002] The present disclosure is related to delivery systems and methods for delivering and deploying a heart valve prosthesis, and in particular, to a retainer for a transcatheter valve delivery system.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 prosthetic valve 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 valve prosthesis can be advanced through the patient’s vasculature. Once positioned at the treatment site, the valve prosthesis can be expanded to engage tissue at the diseased heart valve region to, for instance, hold the valve prosthesis in position.

[0005] In some current delivery systems, a spindle or retainer of a delivery catheter receives an end of the heart valve prosthesis for delivery to a desired treatment location.More specifically, the retainer includes one or more pockets configured to receive a corresponding paddle or connector at an end of the heart valve prosthesis therein. The connectors are radially retained within the corresponding pocket by an outer sheath of the delivery catheter during delivery through the vasculature of a patient. To deploy the heart valve prosthesis at the desired treatment site, the outer sheath of the delivery catheter is proximally retracted to release the connectors from the corresponding pockets of the retainer. The pockets are configured to prevent undesired longitudinal movement of the heart valve prosthesis, but allow the connectors, and hence the heart valve prosthesis, to radially expand out of the pockets. However, in some instances, current pocket designs may result in one or more of the connectors of the heart valve prosthesis not releasing from the corresponding pocket on the first attempt. Stated more directly, one or more of the connectors may be retained or hung up within the pocket of the spindle when the outer sheath is retracted, thereby preventing full expansion and release of the heart valve prosthesis from the delivery catheter. To release the hung connector, the treating physician will maneuver the delivery catheter to force release of the connector from the pocket of the spindle, which may result in procedural complications. The present disclosure relates to improvements relating to such delivery catheters and more specifically to improved retainers for improved release probability of the heart valve prosthesis connector disposed therein.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 proximal portion, a distal portion, and body portion extending between the proximal portion and the distal portion, wherein the body portion is recessed as compared to the proximal portion and the distal portion such that a proximal shoulder is defined at a proximal end of the body portion and a distal shoulder is defined at a distal end of the body portion. The body portion is configured to receive a connector of the heart valve prosthesis. The body portion is pocketless such that the body portion does not include walls extending from the proximal shoulder to the distal shoulder. The retainer further comprises an opening extending longitudinally through the distal portion, the opening configured to receive aportion of the connector of the heart valve prosthesis, and a lumen extending longitudinally through the body, the lumen configured to receive a shaft of the delivery system.

[0007] In another example, in the retainer of any of the preceding or following examples, the proximal shoulder includes a curved portion curving proximally and aligned with the opening through the distal portion such that the body portion is configured to receive the connector of the heart valve prosthesis between the opening and the curved portion.

[0008] In another example, in the retainer of any of the preceding or following examples, the distal portion of the retainer further includes a collar extending distally of the distal shoulder.

[0009] In another example, the retainer of any of the preceding or following examples further comprises a plurality of protrusions extending radially outwardly from the collar, the plurality of protrusions configured to receive endmost crowns of the heart valve prosthesis.

[0010] In another example, in the retainer of any of the preceding or following examples, the retainer comprises a plurality of openings through the distal shoulder.

[0011] In another example, in the retainer of any of the preceding or following examples, the retainer comprises two openings through the distal shoulder, wherein the two openings are disposed 180 degrees apart around a circumference of the retainer.

[0012] In another example, in the retainer of any of the preceding or following examples, the retainer comprises two openings through the distal shoulder, wherein the two openings are not disposed 180 degrees apart around a circumference of the retainer.

[0013] In another example, in the retainer of any of the preceding or following examples, the proximal shoulder includes a plurality of curved portions curving proximally and aligned with the corresponding opening of the plurality of openings through the distal portion such that the body portion is configured to receive a corresponding connector of a plurality of connectors of the heart valve prosthesis between each opening and each curved portion.

[0014] In another example, in the retainer of any of the preceding or following examples, the distal shoulder is stepped circumferentially such that a first opening of the plurality of openings is longitudinally offset from a second opening of the plurality of openings.

[0015] In another example, in the retainer of any of the preceding or following examples, the proximal shoulder is stepped circumferentially.

[0016] In another example, in the retainer of any of the preceding or following examples, the retainer comprises a plurality of proximal wall openings through the proximal shoulder.

[0017] In another example, in the retainer of any of the preceding or following examples, the retainer comprises two proximal wall openings through the proximal shoulder, wherein the two proximal wall openings are disposed opposite each other around a circumference of the retainer.

[0018] In another example, in the retainer of any of the preceding or following examples, the retainer comprises a plurality of distal shoulder openings through the distal shoulder.

[0019] In another example, in the retainer of any of the preceding or following examples, the retainer comprises two distal shoulder openings through the distal shoulder, and the two distal shoulder openings are disposed altematingly with the stem openings.

[0020] In another example of the present application, a delivery system for delivering a heart valve prosthesis to treatment location comprises: a heart valve prosthesis having a first end and a second end, wherein the heart valve prosthesis includes a connector extending from the second end of the heart valve prosthesis; and a delivery catheter configured to percutaneously deliver the heart valve prosthesis. The delivery catheter includes an outer sheath having a distal portion configured to compressively restrain the heart valve prosthesis during delivery, a middle member disposed within an outer sheath lumen of the outer sheath, an inner shaft disposed within a middle member lumen of the middle member, the inner shaft having a distal portion configured to receive the heart valve prosthesis, and a retainer coupled to a distal portion of the middle member, the retainer configured to receive the connector of the heart valve prosthesis to releasably couple the heart valve prosthesis to the delivery catheter. The retainer includes a proximal shoulder, a distal shoulder; and a body portion disposed between the proximal shoulder and the distal shoulder, wherein in a delivery configuration, the connector of the heart valve prosthesis is disposed in the body portion of the retainer, and wherein the body portion is pocketless.

[0021] In another example, in the delivery system of any of the preceding or following examples, the body portion of the retainer is recessed as compared to the proximal shoulder and the distal shoulder, wherein the body portion does not include walls extending from the proximal shoulder to the distal shoulder.

[0022] In another example, in the delivery system of any of the preceding or following examples, the proximal shoulder includes a curved portion curving proximally, and wherein in the delivery configuration, the curved portion is aligned with a proximal end of the connector of the heart valve prosthesis.

[0023] In another example, in the delivery system of any of the preceding or following examples, the retainer further includes a collar extending distally of the distal shoulder.

[0024] In another example, in the delivery system of any of the preceding or following examples, the retainer further comprises a plurality of protrusions extending radially outwardly from the collar, wherein in the delivery configuration, endmost crowns of the second end of the heart valve prosthesis are looped around the protrusions.

[0025] In another example, in the delivery system of any of the preceding or following examples, the retainer further comprises an opening extending longitudinally through the distal shoulder, wherein in the delivery configuration, a stem of the connector extends through the opening.

[0026] In another example, in the delivery system of any of the preceding or following examples, the heart valve prosthesis includes a plurality of connectors, wherein the retainer comprises a plurality of openings extending longitudinally through the distal shoulder, and wherein in the delivery configuration, a corresponding stem of each connector extends through a corresponding opening of the plurality of openings.

[0027] In another example, in the delivery system of any of the preceding or following examples, the retainer comprises two openings through the distal shoulder, wherein the two openings are disposed 180 degrees apart around a circumference of the retainer.

[0028] In another example, in the delivery system of any of the preceding or following examples, the retainer comprises two openings through the distal shoulder, wherein the two openings are not disposed 180 degrees apart around a circumference of the retainer.

[0029] In another example, in the delivery system of any of the preceding or following examples, the proximal shoulder includes a plurality of curved portions curving proximally,wherein the heart valve prosthesis includes a plurality of connectors, and wherein in the delivery configuration, each curved portion of the retainer is aligned with a corresponding connector of the heart valve prosthesis.

[0030] In another example, in the delivery system of any of the preceding or following examples, the proximal shoulder is stepped circumferentially.

[0031] In another example, in the delivery system of any of the preceding or following examples, the distal shoulder is stepped circumferentially.

[0032] In another example, in the delivery system of any of the preceding or following examples, the retainer comprises a plurality of proximal wall openings through the proximal shoulder.

[0033] In another example, in the delivery system of any of the preceding or following examples, the retainer comprises two proximal wall openings through the proximal shoulder, wherein the two proximal wall openings are disposed opposite each other around a circumference of the retainer.

[0034] In another example, in the delivery system of any of the preceding or following examples, the retainer comprises a plurality of distal shoulder openings through the distal shoulder.

[0035] In another example, in the delivery system of any of the preceding or following examples, the retainer comprises two distal shoulder openings through the distal shoulder, and the two distal shoulder openings are disposed altematingly with the stem openings around a circumference of the retainer.

[0036] 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

[0037] The foregoing and other features and advantages of the present disclosure will be apparent from the following description of embodiments hereof as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the presentdisclosure and to enable a person skilled in the pertinent art to make and use the embodiments of the present disclosure. The drawings may not be to scale.

[0038] FIG. 1 depicts a side view illustration of an example delivery system for delivering a heart valve prosthesis.

[0039] FIG. 2 depicts a cross-sectional view taken along line A-A of FIG. 1.

[0040] FIG. 3A depicts a perspective view of a distal portion of the delivery system ofFIG. 1.

[0041] FIG. 3B depicts a side view illustration of a prior art retainer.

[0042] FIG. 4 depicts a perspective view illustration of a retainer of the delivery system of FIG. 1, according to embodiments hereof.

[0043] FIG. 5 depicts a side cross-sectional view of the retainer of FIG. 4.

[0044] FIG. 6 depicts a heart valve prostheses for use in embodiments hereof.

[0045] FIG. 7 depicts an end view illustration of the heart valve prosthesis of FIG. 6.

[0046] FIG. 8 depicts a connector of the heart valve prosthesis of FIG. 6, according to embodiments hereof.

[0047] FIG. 9 depicts a perspective view illustration of a connector the heart valve prosthesis disposed on the retainer of FIG. 4.

[0048] FIG. 10 depicts a side view illustration of a plurality of connectors releasably coupled to the retainer of FIG. 4.

[0049] FIG. 11 depicts a side view illustration of the plurality of connectors releasing from the retainer of FIG. 10.

[0050] FIG. 12 depicts a perspective view illustration of a retainer of the delivery system of FIG. 1, according to embodiments hereof.

[0051] FIG. 13 depicts a side cross-sectional view of the retainer of FIG. 12.

[0052] FIG. 14 depicts a perspective view illustration of a connector the heart valve prosthesis disposed on the retainer of FIG. 12.

[0053] FIG. 15 depicts a side view illustration of a plurality of connectors disposed on the retainer of FIG. 12.

[0054] FIG. 16 depicts a side view illustration of the plurality of connectors releasing from the retainer of FIG. 15.

[0055] FIG. 17 depicts a perspective view illustration of a retainer of the delivery system of FIG. 1, according to embodiments hereof.

[0056] FIG. 18A depicts a side cross-sectional view of the retainer of FIG. 17.

[0057] FIG. 18B depicts a flattened view of the retainer of FIG. 17.

[0058] FIG. 19 depicts an end view of the retainer of FIG. 17.

[0059] FIG. 20 depicts a perspective view illustration of a connector the heart valve prosthesis disposed on the retainer of FIG. 17.

[0060] FIG. 21 A depicts a side view illustration of a plurality of connectors releasably coupled to the retainer of FIG. 17

[0061] FIG. 2 IB depicts a side view illustration of the plurality of connectors releasing from the retainer of FIG. 21 A.

[0062] FIG. 22 depicts a perspective view illustration of a retainer of the delivery system of FIG. 1, according to embodiments hereof.

[0063] FIG. 23A depicts a side cross-sectional view of the retainer of FIG. 22.

[0064] FIG. 23B depicts a flattened view of the retainer of FIG. 22.

[0065] FIG. 24 depicts an end view of the retainer of FIG. 22.

[0066] FIG. 25 depicts a flattened view of a second end of a heart valve prosthesis for use with the retainer of FIG. 22.

[0067] FIG. 26 depicts a side view illustration of a plurality of connectors releasably coupled to the retainer of FIG. 22.

[0068] FIG. 27 depicts a side view illustration of a sequential release of the plurality of connectors from the retainer of FIG. 22.

[0069] FIG. 28 depicts a side perspective view illustration of a retainer of the delivery system of FIG. 1, according to embodiments hereof.

[0070] FIG. 29A depicts a side cross-sectional view of the retainer of FIG. 28.

[0071] FIG. 29B depicts a flattened view illustration of the retainer of FIG. 28.

[0072] FIG. 30 depicts an end view of the retainer of FIG. 28.

[0073] FIG. 31 depicts a flattened view illustration of a second end of a heart valve prosthesis for use with the retainer of FIG. 28.

[0074] FIG. 32 depicts a flattened view illustration of a plurality of connectors disposed on the retainer of FIG. 28.

[0075] FIG. 33 depicts a flattened view illustration of a point in time of a sequential release of a first connector from the retainer of FIG. 32

[0076] FIG. 34 depicts a flattened view illustration of a point in time of a sequential release of a second connector from the retainer of FIG. 32

[0077] FIG. 35 depicts a perspective view illustration of a retainer of the delivery system of FIG. 1, according to embodiments hereof.

[0078] FIG. 36A depicts a side view illustration of the retainer of FIG. 35, according to embodiments hereof.

[0079] FIG. 36B depicts a side view illustration of the retainer of FIG. 36A, rotated 90°, according to embodiments hereof.

[0080] FIG. 37 depicts a perspective view illustration of a connector the heart valve prosthesis disposed on the retainer of FIG. 35.

[0081] FIG. 38 depicts a side view illustration of a plurality of connectors releasably coupled to the retainer of FIG. 35.

[0082] FIG. 39 depicts a side view illustration of the plurality of connectors releasing from the retainer of FIG. 38.

[0083] FIG. 40 depicts a perspective view illustration of a retainer of the delivery system of FIG. 35, according to embodiments hereof.

[0084] FIG. 41A depicts a side view illustration of the retainer of FIG. 40, according to embodiments hereof.

[0085] FIG. 41B depicts a side view illustration ofthe retainer of FIG. 41A, rotated 90°, according to embodiments hereof.DETAILED DESCRIPTION

[0086] 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 orcomponent 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 of the disclosure, background, summary, or the following detailed description.

[0087] 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.

[0088] 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.

[0089] 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 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.

[0090] 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 catheters 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 failed 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.

[0091] Embodiments hereof relate to delivery systems for percutaneously delivering a heart valve prosthesis with improved probability of release. The delivery systems include a spindle or retainer configured to releasably couple the heart valve prosthesis to a delivery catheter for delivery and deployment of the heart valve prosthesis at a desired treatment location. Each retainer is “pocketless”, in that the retainer in the areas where connectors of the heart valve prosthesis sit do not include side walls. Thus, the retainer is configured with improved release characteristics to improve the probability of releasing the heart valve prosthesis from the retainer at the desired treatment location. In embodiments hereof, the improved retainers may be configured to prevent rotation of a portion of the heart valve prosthesis during deployment and may offer a staged, staggered, or sequential release of the heart valve prosthesis.

[0092] 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-sectional view of the delivery system 100. The deliverycatheter 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 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). In the embodiment shown, the middle member 206 is disposed between the inner shaft 208 and the outer sheath 202, and 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. 3A.

[0093] 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 A) 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 A. 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 A. The inner shaft 208 defines a lumen 211 configured to receive a guidewire GW as shown in FIG. 2.

[0094] FIG. 3B shows a prior art spindle or retainer 120. The retainer 120 is a tubular component including a proximal end 124, a distal end 126, and a lumen 122 extending from the proximal end 124 to the distal end 126. The retainer 120 further includes a pocket 130 configured to receive a tab or connector 322 of the heart valve prosthesis 300. Although not shown in FIG. 3B, the retainer 120 includes a second pocket 130 opposite the pocket 130 shown. As shown in FIG. 3B the pocket 130 is a depressed area 131 of the retainer 120 defined by a proximal wall 132, a distal wall 134, and side walls 136 extending between the proximal wall 132 and the distal wall 134. An opening 138 in the distal wall 134 enables a stem 324 of a connector 322 of the heart valve prosthesis 300 to extend therethrough.

[0095] An embodiment of a spindle or retainer 220 of the present disclosure is illustrated in FIGS. 4-5. The retainer 220 is a tubular component including a lumen 222 extending from a proximal end 224 to a distal end 226 of the retainer 220. The retainer 220 may be coupled to the distal end 218 of the middle member 206 by various methods including, but not limited to a threaded coupling, adhesives, fusing, mechanical locks, friction fit, or any other method suitable for the purposes described herein. Thus, the lumen 222 of the retainer 220 may be configured to receive the distal end 218 of the middle member 206 therein. The lumen 222 is also configured to slidingly receive the inner shaft 208 of the delivery catheter 200 therethrough, as shown in FIG. 2, as the inner shaft 208 is disposed within the middle member 206. However, if the middle member 206 is not received within the lumen 222, the lumen 222 is still configured to slidingly receive the inner shaft 208 therethrough. The retainer 220 is configured to releasably couple the heart valve prosthesis 300 to the delivery catheter 200. In embodiments herein, the retainer 220 includes a proximal portion 230, a body portion 232, a distal shoulder portion 234, and a collar 236. The proximal portion 230 distally extends from the proximal end 224, the body portion 232 distally extends from the proximal portion 230, the distal shoulder portion 234 distally extends from the body portion 232, and the collar 236 distally extends from the distal shoulder portion 234.

[0096] The proximal portion 230 includes a flared outer surface 238 distally extending from the proximal end 224 of the retainer 220 to a distal end 240 of the proximal portion 230. The body portion 232 includes a cylindrical outer surface 246 extending from a proximal end 248 adjacent the distal end 240 of the proximal portion 230, to a distal end 250. The outer surface 246 of the body portion 232 is depressed inwardly with respect tothe distal end 240 of the proximal portion 230. Stated another way, a first radius R1 measured from the central longitudinal axis CLA of the retainer 220 to the outer surface 238 at the distal end 240 of the proximal portion 230 is larger than a second radius R2 measured from the central longitudinal axis CLA to the outer surface 246 of the body portion 232, thereby forming a shoulder or surface 243 extending radially outwardly from the outer surface 246 of the body portion 232 to the outer surface 238 of the proximal portion 230, as shown in FIGS. 4 and 5.

[0097] The surface 243 at the distal end 240 of the proximal portion 230 / proximal end 248 of the body portion 232 includes plurality of curved sections 242 configured to align with the tabs or connectors 322 of the heart valve prosthesis 300. Only one curved section 242 is shown in FIG. 4, but the retainer 220 includes curved sections 242 equal to the number of tabs or connectors 322 of the heart valve prosthesis 300. Thus, if the heart valve prosthesis 300 includes two connectors 322, or three connectors 322, or four connectors 322, the retainer 220 may include two curved sections 242, or three curved sections 242, or four curved sections 242, respectively. At each curved section 242, the surface 243 extends proximally and circumferentially in an arc from a first end 245 to an apex 244, and then distally and circumferentially in an arc to a second end 247, as shown in FIG. 4. Thus, the apex 244 is disposed proximally of the first and second ends 245, 247 of the curved section 242.

[0098] The distal shoulder portion 234 of the retainer 220 includes a generally cylindrical outer surface 252 distally extending from a proximal end 254 adjacent the distal end 250 of the body portion 232, to a distal end 256. The distal shoulder portion 234 includes a proximal shoulder or surface 257 extending radially outward from the outer surface 246 of the body portion 232 to the outer surface 252 of the distal shoulder portion 234 at the proximal end 254 of the distal shoulder portion 234. A third radius R3 measured from the central longitudinal axis CLA of the retainer 220 to the outer surface 252 at the proximal end 254 of the distal shoulder portion 234 is larger than the second radius R2 measured from the central longitudinal axis CLA to the outer surface 246 of the body portion 232, thereby forming the proximal shoulder or surface 257, as shown in FIGS. 4 and 5. In the embodiments of FIGS. 4-5, the third radius R3 is equivalent to the first radius Rl, however this is not meant to be limiting, and in other embodiments hereof, the third radius R3 maybe larger or smaller than the first radius R1. The distal shoulder portion 234 further includes a plurality of openings 258. As best shown in FIG. 4, each opening 258 is circumferentially aligned along a center line CL1 of a corresponding curved section 242 of the proximal portion 230. Each opening 258 extends radially inward from the outer surface 252 of the distal shoulder portion 234 such that an outer surface 260 of each opening 258 has a fourth radius R4 measured from the central longitudinal axis CLA to the outer surface 260 of each opening 258, as shown in FIG. 5. In embodiments herein, the fourth radius R4 is equal to the second radius R2 of the outer surface 246 of the body portion 232. Stated another way, the outer surface 260 of each opening 258 is level with the outer surface 246 of the body portion 232. Each opening 258 is configured to receive the stem 324 of the corresponding connector 322 of the heart valve prosthesis 300.

[0099] The collar 236 includes a cylindrical outer surface 264 extending from a proximal end 262 adjacent the distal end 256 of the distal shoulder portion 234, to the distal end 226 of the retainer 220. The outer surface 264 is recessed with respect to the distal shoulder portion 234. A fifth radius R5 measured from the central longitudinal axis CLA of the retainer 220 to the outer surface 264 of the collar 236 is smaller than the third radius R3 measured from the central longitudinal axis CLA to the outer surface 252 of the distal shoulder portion 234, thereby forming a distal shoulder or surface 266 extending from the outer surface 264 of the collar 236 at the proximal end 262 of the collar 236 to the outer surface 252 at the distal end 256 of the distal shoulder portion 234. In embodiments herein, the fifth radius R5 is smaller than or equal to the fourth radius R4 of the openings 258 of the distal shoulder portion 234.

[0100] FIGS. 6-7 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, and in particular, with the retainers 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 ofalternate 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. 6-7 may be removed and / or additional components may be added to the heart valve prosthesis 300.

[0101] 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.

[0102] 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. 6. 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.

[0103] 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 is relatively wider, or is larger than 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.

[0104] FIG. 8 illustrates a connector 322 of the plurality of connectors 322. Each connector 322 includes the stem 324 and a 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 curved distaledge (third edge 330). 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 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.

[0105] FIG. 9 is a perspective view of the retainer 220 of the delivery catheter 200 with the connector 322 of the heart valve prosthesis 300 disposed therein. The connector 322 is disposed within the body portion 232 of the retainer 220. The stem 324 of the connector 322 is disposed within the corresponding opening 258 of the distal shoulder portion 234 of the retainer 220. The third edge 330 of the paddle 325 of the connector 322 is disposed adjacent to the curved section 242 of the retainer 220. With the outer sheath 202 disposed over the retainer 220 and the connector 322, the outer sheath 202 retains the connector 322 within the body portion 232 of the retainer 220 to releasably couple the connector 322 to the retainer 220. Accordingly, with the outer sheath 202 over the retainer 220 and the plurality of connectors 322, the heart valve prosthesis 300 is releasably coupled to the delivery catheter 200. Each connector 322 is longitudinally constrained within the body portion 232 of the retainer 220 by the proximal portion 230 and the distal shoulder portion 234 of the retainer 220, and radially or compressively restrained by the outer sheath 202. In greater detail, the third edge 330 of the connector 322 is disposed adjacent to the curved section 242 of the proximal portion 230 of the retainer 220. The curved section 242 prevents the connector 322 from moving in a proximal direction relative to the delivery catheter 200. The first edge 326 and the fifth edge 334 of the connector 322 are each disposed adjacent to the distal shoulder portion 234 of the retainer 220, with the stem 324 extending through the opening 258 in the distal shoulder portion 234. The distal shoulder portion 234 prevents the connector 322 from moving in a distal direction relative to the delivery catheter 200, such as but not limited to during loading of the transcatheter heart valve prosthesis 300 into the delivery catheter 200 or recapture of the heart valve prosthesis 300. Each connector 322 is rotationally constrained by the stem 324 disposed within the corresponding opening 258 ofthe retainer 220. The connector 322 is radially retained adjacent to the outer surface 246 of the body portion 232 of the retainer 220 by the outer sheath 202.

[0106] The release of the heart valve prosthesis 300 from the delivery catheter 200 will now be described with reference to FIGS. 10-11. FIG. 10 shows the second end 310 of the heart valve prosthesis 300 in the radially compressed configuration within the outer sheath 202 and releasably coupled to the retainer 220 of the delivery catheter 200. FIG. 11 illustrates a point in time during the release of the plurality of connectors 322 from the retainer 220. Prior to the deployment of the heart valve prosthesis 300 in situ, as shown in FIG. 10, the paddles 325 of the plurality of connectors 322 of the heart valve prosthesis 300 are disposed within the body portion 232 of the retainer 220 of the delivery catheter 200. Each connector 322 is retained in the retainer 220 by the outer sheath 202 to releasably couple the heart valve prosthesis 300 to the delivery catheter 200. To release the heart valve prosthesis 300 at the desired treatment location, the outer sheath 202 is proximally retracted relative to the retainer 220 and the heart valve prosthesis 300. As the outer sheath 202 is retracted, the heart valve prosthesis 300 distal of the retainer 220 radially expands. As long as the connectors 322 are coupled to the retainer 220, the outer sheath 202 may be advanced distally to recapture the heart valve prosthesis 300. During retraction of the outer sheath 202, friction between the heart valve prosthesis 300 and the outer sheath 202 tends to draw the heart valve prosthesis 300 in a proximal direction relative to the retainer 220. The connectors 322 disposed in retainer 220 prevent longitudinal movement of the heart valve prosthesis 300 relative to the inner shaft 208. In particular, the third edge 330 of the paddle 325 of each connector 322 abuts the corresponding curved section 242 of the proximal portion 230 of the retainer 220, thereby preventing proximal movement of the heart valve prosthesis 300. As the outer sheath 202 travels proximally over the heart valve prosthesis 300, the exposed portions of the heart valve prosthesis 300 are released and begin to radially self-expand. The heart valve prosthesis 300 self-expands from the first end 308 to the second end 310. As the outer sheath 202 proximally retracts over retainer 220, the connectors 322 begin to release from the retainer 220. As shown in FIG. 11, when the outer sheath 202 of the delivery catheter 200 is retracted past the body portion 232 of the retainer 220, the connectors 322 are fully released and the heart valve prosthesis 300 may fully deploy to the radially expanded configuration. The inventors have found that utilizing a “pocketless”retainer reduces or eliminates paddle / connector hang up, thereby improving release of the heart valve prosthesis 300 from the delivery catheter 200.

[0107] FIGS. 12-16 show a spindle or retainer 1220 according to another embodiment hereof. The retainer 1220 is the same as the retainer 220 shown in FIGS. 4-5 and 9-11 except as described herein. Therefore, all of the details described above are incorporated into the description of FIGS. 12-16 and the same reference numerals are used. Thus, generally, as described above, the retainer 1220 includes the proximal end 224, the distal end 226, and the lumen 222. The retainer 1220 further includes the proximal portion 230, the body portion 232, the distal shoulder portion 234, and the collar 236. However, the retainer 1220 of FIGS. 12-16 differs from the retainer 220 in that the retainer 1220 further includes a plurality of protrusions 1268 extending radially outwardly from the collar 236 of the retainer 1220.

[0108] In a non-limiting embodiment, each protrusion 1268 may be substantially hexagonally shaped in cross-section. However, this is not meant to be limiting, and each protrusion 1268 may be other shapes in cross-section, such as but not limited to circular, rectangular, square, or other shapes. Each protrusion 1268 is configured to engage a corresponding endmost crown 318 at the second end 310 of the heart valve prosthesis 300 (FIG. 6) to maintain the heart valve prosthesis 300 in the desired rotational orientation during loading and during deployment at a desired treatment location. The plurality of protrusions 1268 is configured to improve prevention of infolding, alleviate asymmetric forces, and prevent fold over during loading of the heart valve prosthesis 300 into the delivery catheter 200. Each protrusion 1268 extends from the outer surface 264 of the collar 236 defining a sixth radius R6 measured from the central longitudinal axis CLA of the retainer 1220 to an outer surface 1270 of each protrusion 1268, as shown in FIG. 13. The sixth radius R6 is greater than the fifth radius R5 measured from the central longitudinal axis CLA to the outer surface 264 of the collar 236 due to the protrusions 1268 extending from the outer surface 264. Further, in embodiments, the sixth radius R6 is smaller than or equal to the third radius R3 measured from the central longitudinal axis CLA to the outer surface 252 of the distal shoulder portion 234. While a specific number of protrusions 1268 are shown in FIG. 12 equal to the number of endmost crowns 318 of the heart valve prosthesis 300, it will be understood by those skilled in the art that more or fewer protrusionsmay be utilized and that the number of protrusions need not equal the number of endmost crowns 318. Further, the sixth radius R6 may be larger or smaller.

[0109] FIG. 14 is a perspective view of the retainer 1220 with the connector 322 of the heart valve prosthesis 300 disposed therein. The paddle 325 of the connector 322 is disposed within the body portion 232 and the stem 324 of the connector 322 is disposed within the corresponding opening 258 of the distal shoulder portion 234 of the retainer 1220. The protrusion 1268 adjacent to the stem 324 is disposed through the side opening 316 at the endmost crown 318 adjacent to the connector 322. Further, the protrusions 1268 that are not adjacent to the openings 258 in the distal shoulder portion 234 are disposed through corresponding side openings 316 at the corresponding endmost crowns 318 that do not include connectors 322 extending therefrom. The outer sheath 202 retains the connector 322 within the body portion 232 of the retainer 1220 and retains the endmost crowns 318 coupled to the protrusions 1268 to releasably couple the heart valve prosthesis 300 to the retainer 1220, and to thereby releasably couple the heart valve prosthesis 300 to the delivery catheter 200. Each connector 322 is longitudinally constrained within the body portion 232 of the retainer 1220 by the curved section 242 of the proximal portion 230 and the distal shoulder portion 234, and radially by the outer sheath 202. Each connector 322 is rotationally constrained by the stem 324 disposed within the corresponding opening 1258 of the retainer 1220 and the corresponding endmost crown 318 is rotationally constrained by the corresponding protrusion 1268 of the retainer 1220. Stated another way, each connector 322 is restricted from movement in a proximal direction relative to the retainer 1220 by the proximal portion 230, in a distal direction relative to the retainer 1220 by the distal shoulder portion 234, in a radial direction by the body portion 232 and the outer sheath 202, and in a rotational direction by the distal shoulder portions 234 adjacent the opening 258 and by the adjacent protrusion 1268.

[0110] FIGS. 15-16 illustrate specific points in time just prior to and during the release of the second end 310 of the heart valve prosthesis 300 from the delivery catheter 200 with the retainer 1220. FIGS. 15-16 each illustrate the heart valve prosthesis 300, in situ. FIG. 15 shows the second end 310 of the heart valve prosthesis 300 coupled to the retainer 1220 prior to release and deployment of the second end 310. As can be seen, the connectors 322 and the endmost crowns 318 are coupled to the retainer 1220 and the outer sheath 202 isdisposed over the retainer 1220 and the connectors 322, thereby maintaining the second end 310 in the radially compressed configuration. As the outer sheath 202 is retracted, the heart valve prosthesis 300 distal of the retainer 1220 radially expands. As long as the connectors 322 are coupled to the retainer 220, the outer sheath 202 may be advanced distally to recapture the heart valve prosthesis 300. Friction between the heart valve prosthesis 300 and the outer sheath 202 during proximal retraction of the outer sheath 202 tends to draw the heart valve prosthesis 300 in a proximal direction relative to the retainer 1220. The connectors 322 disposed in retainer 1220 prevent longitudinal movement of the heart valve prosthesis 300 relative to the middle member 206. In particular, the third edge 330 of the paddle 325 of each connector 322 abuts the corresponding curved section 242 of the proximal portion 230 of the retainer 1220, thereby preventing proximal movement of the heart valve prosthesis 300. As the outer sheath 202 travels proximally over the heart valve prosthesis 300, the exposed portions of the heart valve prosthesis 300 are released and begin to radially self-expand. The heart valve prosthesis 300 self-expands from the first end 308 to the second end 310. As the outer sheath 202 proximally retracts over retainer 1220, the connectors 322 begin to release from the retainer 1220. When the outer sheath 202 is retracted past the body portion 232 of the retainer 1220, the connectors 322 are fully released and the heart valve prosthesis 300 may fully deploy to the radially expanded configuration, as shown in FIG. 16. As noted above, utilizing a “pocketless” retainer reduces or eliminates paddle / connector hang up, thereby improving release of the heart valve prosthesis 300 from the delivery catheter 200. Further, the plurality of protrusions 1268 maintain the corresponding endmost crowns 318, and accordingly the corresponding stem 324 and the connector 322 in the correct rotational orientation during deployment. Rotation of a connector 322 during deployment of the heart valve prosthesis 300 increases the probability of the connector 322 binding or not releasing from the retainer 1220, and thereby preventing full deployment of the heart valve prosthesis 300. Thus, as noted above the protrusions 1268 also improve prevention of infolding, alleviate asymmetric forces, and prevent fold over during loading of the heart valve prosthesis 300 into the delivery catheter 200. It is also noted that the protrusions 1268 described with respect to FIGS. 12-16 may be used in any of the embodiments described herein.

[0111] FIGS. 17-2 IB illustrate a spindle or retainer 1720 with improved release characteristics, according to embodiments hereof. The retainer 1720 is configured to be used with a delivery catheter, for example the delivery catheter 200 previously described, to releasably couple the delivery catheter 200 to a heart valve prosthesis, for example the heart valve prosthesis 300 shown in FIG. 6, for delivery to and deployment at a desired treatment location.

[0112] The retainer 1720 is a tubular component including a lumen 1722 extending from a proximal end 1724 to a distal end 1726, as best shown in FIG. 17. The retainer 1720 may be coupled to the distal end 218 of the middle member 206 of the delivery catheter 200 as described previously. The lumen 1722 is configured to receive the inner shaft 208 of the delivery catheter 200, as the inner shaft 208 is disposed within the middle member 206. However, if the middle member 206 is not received within the lumen 1722, the lumen 1722 is still configured to receive the inner shaft 208. In embodiments herein, the retainer 1720 includes a proximal portion 1730, a body portion 1732, a distal shoulder portion 1734, and a collar 1736. The proximal portion 1730 distally extends from the proximal end 1724, the body portion 1732 distally extends from the proximal portion 1730, the distal shoulder portion 1734 distally extends from the body portion 1732, and the collar 1736 distally extends from the distal shoulder portion 1734.

[0113] As shown in FIGS. 17-18B, the proximal portion 1730 includes a flared outer surface 1738 distally extending from the proximal end 1724 of the retainer 1720 to a distal end 1740 of the proximal portion 1730. The body portion 1732 includes a cylindrical outer surface 1746 extending from a proximal end 1748 adjacent the distal end 1740 of the proximal portion 1730 to a distal end 1750. The outer surface 1746 of the body portion 1732 is depressed inwardly with respect to the outer surface 1738 at the distal end 1740 of the proximal portion 1730. As illustrated in FIG. 18A, a first radius R1 measured from the central longitudinal axis CLA of the retainer 1720 to the outer surface 1738 at the distal end 1740 of the proximal portion 1730 is larger than a second radius R2 measured from the central longitudinal axis CLA to the outer surface 1746 of the body portion 1732, thereby forming a shoulder or first surface 1743 extending between the outer surface 1738 of the proximal portion 1730 and the outer surface 1746 of the body portion 1732. In embodiments herein, the first surface 1743 is substantially perpendicular to the outer surface 1746 of thebody portion 1732. The outer surface 1746 of the body portion 1732 is configured to receive the paddles 325 of the connectors 322 of the heart valve prosthesis 300. The shoulder or first surface 1743 ofthe embodiment of FIGS. 17-21B does not include the curved sections, such as the curved sections 242 shown in FIGS. 4 and 9). However, the shoulder or first surface 1743 may include similar curved sections aligned with the openings 1758 described below.

[0114] The distal shoulder portion 1734 of the retainer 1720 includes a generally cylindrical outer surface 1752 distally extending from a proximal end 1754 adjacent the distal end 1750 of the body portion 1732, to a distal end 1756. The distal shoulder portion 1734 includes a proximal shoulder or surface 1757 extending radially outwardly from the outer surface 1746 of the body portion 1732 to the outer surface 1752 of the distal shoulder portion 1734 at the proximal end 1754 ofthe distal shoulder portion 1734. A third radius R3 measured from the central longitudinal axis CLA of the retainer 1720 to the outer surface 1752 at the proximal end 1750 of the distal shoulder portion 1734 is larger than the second radius R2 measured from the central longitudinal axis CLA to the outer surface 1746 of the body portion 1732, thereby forming the proximal shoulder or surface 1757, as shown in FIGS. 17 and 18 A. In the embodiment of FIGS. 17-2 IB, the third radius R3 is equivalent to the first radius Rl, however this is not meant to be limiting, and in other embodiments hereof, the third radius R3 may be larger or smaller than the first radius Rl . The distal shoulder portion 1734 further includes plurality of openings 1758. Each opening 1758 is configured to receive the stem 324 of a corresponding one of the connectors 322 of the heart valve prosthesis 300, as shown in FIG. 20. Each opening 1758 extends radially inward from the outer surface 1752 of the distal shoulder portion 1734 such that an outer surface 1760 of each opening 1758 defines a fourth radius R4 measured from the central longitudinal axis CLA to the outer surface 1760, as shown in FIG. 18A. In embodiments herein, the fourth radius R4 is equal to the second radius R2 of the body portion 1732. Stated another way, the outer surface 1760 of each opening 1758 is level with the outer surface 1746 of the body portion 1732. As shown in FIG. 19, the first opening 1758A and the second opening 1758B are not equally spaced around a circumference of the distal shoulder portion 1734. With reference to FIG. 6, the heart valve prosthesis 300 includes an odd number of endmost crowns 318 at the second end 310 thereof. Accordingly, the two connectors 322 may not bedisposed exactly 180° apart. In the embodiment of FIGS. 17-21B, the two openings 1758A, 1758B of the distal shoulder portion 1734 are disposed to correspond with the two connectors 322 of the heart valve prosthesis 300. In other words, the openings 1758A, 1758B are slightly offset from being disposed circumferentially 180° apart. While described herein with the two openings 1758A, 1758B corresponding to the two connectors 322 of the heart valve prosthesis 300, this is not meant to be limiting. In another nonlimiting example, the retainer may include more or fewer openings corresponding to a heart valve prosthesis with more or fewer connectors 322.

[0115] The collar 1736 includes a cylindrical outer surface 1764 extending from a proximal end 1762 adjacent to the distal end 1756 of the distal shoulder portion 1734, to the distal end 1726 of the retainer 1720. The outer surface 1764 is recessed with respect to the distal shoulder portion 1734. A fifth radius R5 measured from the central longitudinal axis CLA of the retainer 1720 to the outer surface 1764 of the collar 1736 is smaller than the fourth radius R4 measured from the central longitudinal axis CLA to the outer surface 1752 of the distal shoulder portion 1734, thereby forming a distal shoulder or surface 1766 extending from the outer surface 1764 of the collar 1736 at the proximal end 1762 to the outer surface 1752 ofthe distal shoulder portion 1734 at the distal end 1756. In embodiments herein, the fifth radius R5 is smaller than or equal to the fourth radius R4 at the openings 1758 ofthe distal shoulder portion 1734. As noted above, although the embodiment of FIGS. 17-21B does not show projections extending radially from the collar 1736, this is not meant to be limiting, and projections such as the projections 1268 may be included.

[0116] FIG. 20 is a perspective view of the retainer 1720 of the delivery catheter 200 with each connector 322 of the heart valve prosthesis 300 releasably coupled to the retainer 1720. Each paddle 325 of the connectors 322 is disposed within the body portion 1732 of the retainer 1720 and the stem 324 of each connector 322 is disposed within the corresponding opening 1758 of the distal shoulder portion 1734 of the retainer 1720. The third edge 330 of the paddle 325 of each connector 322 is disposed adjacent the shoulder or first surface 1743 of the retainer 1720. When the outer sheath 202 is disposed over the retainer 1720 and the connectors 322, the outer sheath 202 retains each connector 322 within the body portion 1732 of the retainer 1720 to releasably couple the heart valve prosthesis 300 to the retainer 1720. In embodiments herein, each connector 322 is longitudinallyconstrained within the body portion 1732 of the retainer 1720 by the third edge 330 of each connector 322 disposed adjacent the shoulder or first surface 1743 of the retainer 1720, thereby preventing movement of each connector 322 in a proximal direction relative to the delivery catheter 200, and the first edge 326 and the fifth edge 334 of each connector 322 disposed adjacent the distal shoulder portion 1734 of the retainer 1720, with the stem 324 extending through the corresponding opening 1758 in the distal shoulder portion 1734, thereby preventing movement of each connector 322 in a distal direction relative to the delivery catheter 200. Each connector 322 is radially retained adjacent the outer surface 1746 of the body portion 1732 of the retainer 1720 by the outer sheath 202. Each connector 322 is rotationally constrained by the stem 324 disposed within the corresponding opening 1758 of the retainer 1720.

[0117] FIG. 21A shows the second end 310 of the heart valve prosthesis 300 in the radially compressed configuration and releasably coupled to the retainer 1720 by the outer sheath 202 of the delivery catheter 200. FIG. 2 IB shows the plurality of connectors 322 of the heart valve prosthesis 300 at a point in time during release from the retainer 1720. As shown in FIG. 21 A, prior to release the heart valve prosthesis 300 in situ, the paddles 325 of the plurality of connectors 322 of the heart valve prosthesis 300 are disposed within the body portion 1732 of the retainer 1720 of the delivery catheter 200. Each connector 322 is retained in the retainer 1720 by the outer sheath 202 to releasably couple the heart valve prosthesis 300 to the delivery catheter 200. The outer sheath 202 is proximally retracted relative to the retainer 1720 and the heart valve prosthesis 300 to release the heart valve prosthesis 300 at the desired location. As the outer sheath 202 is proximally retracted, the heart valve prosthesis 300 distal of the retainer 1720 radially expands. As long as the connectors 322 are coupled to the retainer 1720, the outer sheath 202 may be advanced distally to recapture the heart valve prosthesis 300. Friction between the heart valve prosthesis 300 and the outer sheath 202 during proximal retraction of the outer sheath 202 tends to draw the heart valve prosthesis 300 in a proximal direction relative to the retainer 1720. Similarly, friction between the heart valve prosthesis 300 and the outer sheath 202 during distal advancement of the outer sheath 202, such as during recapture and / or loading of the heart valve prosthesis 300 into the delivery catheter 202, creates a force on heart valve prosthesis 300 in a distal direction relative to the retainer 1720. The connectors 322 disposedin the retainer 1720 prevent proximal and distal longitudinal movement of the heart valve prosthesis 300 relative to the inner shaft 208. In greater detail, the third edge 330 of the paddle 325 of each connector 322 abuts the first surface 1743 at the distal end 1740 of the proximal portion 1730 of the retainer 1720, thereby preventing proximal movement of the heart valve prosthesis 300. Similarly, the first edge 326 and the fifth edge 334 of the connector 322 are each disposed adjacent to the distal shoulder portion 1734 of the retainer 1720, with the stem 324 extending through the opening 1758 in the distal shoulder portion 234. The distal shoulder portion 1734 prevents the connector 322 from moving in a distal direction relative to the retainer 1720.

[0118] As the outer sheath 202 is proximally retracted and travels proximally over the heart valve prosthesis 300, the exposed portions of the heart valve prosthesis 300 are released and begin to radially self-expand. The heart valve prosthesis 300 expands from the first end 308 to the second end 310. As the outer sheath 202 proximally retracts over the retainer 1720, each connector 322 begins to release from the retainer 1720. As shown in FIG. 21B, when the outer sheath 202 is retracted past the body portion 1732 of the retainer 1720, the connectors 322 are fully released and the heart valve prosthesis 300 may fully deploy to the radially expanded configuration. The inventors have found that utilizing a “pocketless” retainer reduces or eliminates paddle / connector hang up, thereby improving release of the heart valve prosthesis 300 from the delivery catheter 200.

[0119] FIGS. 22-27 illustrate a spindle or retainer 2220 according to another embodiment hereof. The retainer 2220 is the same as the retainer 1720 shown in FIGS. 17- 20 except as described herein. Therefore, all of the details described above are incorporated into the description of FIGS. 22-27 and the same reference numerals are used. Thus, generally, as described above, the retainer 2220 includes the proximal end 1724, the distal end 1726, and the lumen 1722. The retainer 2220 further includes the proximal portion 1730, the body portion 1732, the distal shoulder portion 1734, and the collar 1736. However, the retainer 2220 of FIGS. 22-27 differs from the retainer 1720 in that the retainer 2220 further includes a stepped shoulder or first surface 2243 extending radially outwardly from the outer surface 1746 of the body portion 1732 to the outer surface 1738 of the proximal portion 1730 (see FIG. 23B), and a corresponding stepped proximal shoulder 2257 of the distalshoulder portion 1734 (see FIGS. 22 and 23B). However, although a stepped shoulder or first surface 2243 is shown, it need not be stepped.

[0120] In a non-limiting embodiment, the shoulder or first surface 2243 of the retainer 2220 includes a first portion 2243A and a second portion 2243B, as shown in FIG. 23B. The proximal shoulder 2257 of the distal shoulder portion 1734 includes a first portion 2257A corresponding to the first portion 2243 A and a second portion 2257B corresponding to the second portion 2243B. The first portion 2243A of the first surface 2243 and the first portion 2257A of the proximal shoulder 2257 of the distal shoulder portion 1734 each extends equally and on opposite sides of a first centerline CL1 of a first opening 1758A. The second portion 2243B of the first surface 2243 and the second portion 2257B of the proximal shoulder 2257 of the distal shoulder portion 1734 each extends equally and on opposite sides of a second centerline CL2 of a second opening 1758B of the retainer 2220.

[0121] In embodiments herein, the first portion 2243 A is spaced a first distance D 1 from a distal end 1756 of the distal shoulder portion 1734. The second portion 2243B is spaced a second distance D2 from the distal end 1756 of the distal shoulder portion 1734. In embodiments herein, the first distance DI is less than the second distance D2. In other words, the second portion 2243B of the shoulder or first surface 2243 is longitudinally more proximal than the first portion 2243 A of the shoulder or first surface 2243, as best seen in FIG. 23B. Similarly, the second portion 2257B of the proximal shoulder 2257 of the distal shoulder portion 1734 is more proximal than the second portion 2257A of the proximal shoulder 2257. In the embodiment shown, this longitudinal offset is established by making the distal shoulder portion 1734 at the first portion 2257A thinner longitudinally than the distal shoulder portion 1734 at the second portion 2257B, as shown in FIG. 23B. As can be seen in FIG. 23B, the opening 1758A is disposed within the first portion 2257A and the openings 1758B is disposed within the second portion 2257B. The longitudinal offset of the openings 1758A, 1758B enable a sequential release the connectors 322 of a heart valve prosthesis.

[0122] In the embodiment of FIGS. 22-27, due to both the shoulder or first surface 2243 and the proximal shoulder 2257 of the distal end of the proximal portion 1730 and the proximal shoulder 2257 of the distal shoulder portion 1734 being stepped, the body portion 1732 has a consistent length D3 between the first surface 2243 at the distal end 1740 of theproximal portion 1730 and the proximal end 1754 of the distal shoulder portion 1734. However, in other embodiments in which only the distal shoulder portion 1734 includes the stepped proximal shoulder 2257, the length D3 may be varied around the circumference of the retainer 2220. In yet other embodiments, the distal shoulder portion 1734 includes the stepped proximal shoulder 2257 and the distal end 1756 of the proximal portion 1730 includes curved portions aligned with the openings 1758, such as curved portions 242 shown in FIGS. 4, 9, 12, and 14.

[0123] FIG. 25 illustrates a flattened portion of the heart valve prosthesis 300 near the second end 310. For embodiments of FIGS. 22-27, the heart valve prosthesis 300 may include a first connector 322A and a second connector 322B. The first connector 322A includes a stem 324A with a first length LI and the second connector 322B includes a stem 324B with a second length L2, as measured from the endmost crowns 318 at the second end 310 of the heart valve prosthesis 300. In embodiments herein, the first length LI is less than the second length L2, such that the first connector 322A may be disposed within the body portion 1732 adjacent to the first portion 2243 A of the first surface 2243 of the retainer 2220 and the second connector 322B may be disposed within the body portion 1732 adjacent to the second portion 2243B of the first surface 2243.

[0124] FIG. 26 shows the second end 310 of the heart valve prosthesis 300 in the radially compressed configuration and releasably coupled to the retainer 2220 by the outer sheath 202 of the delivery catheter 200. The heart valve prosthesis 300 is shown in situ, prior to release in FIG. 26. The paddles 325 of the plurality of connectors 322A, 322B of the heart valve prosthesis 300 are disposed within the body portion 1732 of the retainer 2220 of the delivery catheter 200. Each connector 322A, 322B is retained in the retainer 2220 by the outer sheath 202 to releasably couple the heart valve prosthesis 300 to the delivery catheter 200. The outer sheath 202 is proximally retracted relative to the retainer 2220 and the heart valve prosthesis 300 to release the heart valve prosthesis 300 at the desired location. As described previously with respect to the retainer 1720 of FIG. 21 A, the connectors 322A, 322B are disposed in the retainer 2220 and prevent longitudinal movement of the heart valve prosthesis 300 relative to the inner shaft 208. As the outer sheath 202 is proximally retracted and travels proximally over the heart valve prosthesis 300, the exposed portions of the heartvalve prosthesis 300 are released and begin to radially self-expand. The heart valve prosthesis 300 self-expands from the first end 308 to the second end 310.

[0125] The sequential release of the heart valve prosthesis will now be described with reference to FIG. 27. As the outer sheath 202 of the delivery catheter 200 proximally retracts over the retainer 2220, the stepped shoulder or first surface 2243 and the stepped shoulder 2257 permit the sequential or staggered release of each connector 322 from the retainer 1720. More specifically, when the outer sheath 202 is retracted, the distal end of the outer sheath 202 first passes proximally past the first connector 322A, thereby releasing the first connected 322A, as shown in FIG. 27. When the first connector 322A is released, the first connector 322A and a portion of the heart valve prosthesis 300 begins to radially expand, as shown in FIG. 27. When the outer sheath 202 is further retracted proximally, the distal end of the outer sheath 202 passes proximally past and releases the second connector 322B. When the second connector 322B is released, the plurality of connectors 322A, 322B are fully released and the heart valve prosthesis 300 may fully deploy to the radially expanded configuration. Thus, the first connector 322A and the second connector 322B are released sequentially.

[0126] FIGS. 28-34 illustrate a spindle or retainer 2820 according to another embodiment hereof. The retainer 2820 is the same as the retainer 2220 shown in FIGS. 22- 27 except as described herein. Thus, all of the details described above with respect to the retainer 1720 and the retainer 2220 are incorporated into the description of FIGS. 28-34 and the same reference numerals are used, except where described otherwise. Thus, as described above, the retainer 2820 includes the proximal end 1724, the distal end 1726, and the lumen 1722. The retainer 2820 further includes the proximal portion 1730, the body portion 1732, the distal shoulder portion 1734, and the collar 1736. However, the retainer 2820 differs from the retainer 2220 in that the distal shoulder portion 1734 of retainer 2820 includes three (3) openings 1758 for embodiments where the heart valve prosthesis includes three (3) connectors. Further, the first shoulder or surface 2843 of the proximal portion 1730 and the proximal shoulder 2857 of the distal shoulder portion 1734 each including three (3) corresponding stepped portions. Those skilled in the art will recognize that the three (3) openings 1758 described below with respect to the embodiment of FIGS. 28-34 may be used in other embodiments described herein without the stepped first shoulder 2843 and / orwithout the stepped proximal shoulder 2857 of the distal shoulder portion 1734. Further, as described above, in some embodiments, only the stepped proximal shoulder 2857 of the distal shoulder portion may be incorporated. In such embodiments, the first shoulder or surface 1743 may be cylindrical, as shown in the embodiment of FIGS 17-2 IB, or may include the curved portions 242 aligned with corresponding openings 1758, as shown in the embodiment of FIGS. 4-5 and 12-16.

[0127] Returning to the embodiment shown in FIGS. 28-34, the first surface 2843 includes a first portion 2843A, a second portion 2843B, and a third portion 2843C, and the proximal shoulder 2857 of the distal shoulder portion 1734 includes a corresponding first portion 2857A, second portion 2857B, and third portion 2857C, as best shown in FIG. 29B. The first and second portions 2843 A, 2843B of the first surface 2843 and the first and second portions 2857A, 2857B of the distal shoulder portion 1734 are each disposed on the retainer 2820 as previously described with respect to the first and second portions 2243 A, 2243B and the first and second portions 2257A, 2257B, respectively, of FIG. 23. The third portion 2843C of the first surface 2843 and the third portion 2857C of the proximal shoulder 2857 of the distal shoulder portion 1734 each extends equally and on opposite sides of a third centerline CL3 of a third opening 1758C of the retainer 2820.

[0128] In embodiments herein, the first portion 2843A is spaced a first distance D 1 from a distal end 1756 of the distal shoulder portion 1734. The second portion 2843B is spaced a second distance D2 from the distal end 1756 of the distal shoulder portion 1734. The third portion 2843C is spaced a third distance D3 from the distal end 1756 of the distal shoulder portion 1734. In embodiments herein, the first distance DI is less than the second distance D2, and the second distance D2 is less than the third distance D3. The first, second, and third portions 2843A, 2843B, 2843C of the first surface 2843 at the distal end 1740 of the proximal portion 1730 are configured to sequentially release the connectors 322 of a heart valve prosthesis 300.

[0129] In embodiments herein, the body portion 1732 of the retainer 2820 has a consistent length D4 between the first surface 2843 at the distal end 1740 of the proximal portion 1730 and the proximal end 1754 of the distal shoulder portion 1734. However, in other embodiments in which only the distal shoulder portion 1734 includes the steppedproximal shoulder 2857, the length D4 may be varied around the circumference of the retainer 2820.

[0130] FIG. 31 illustrates a flattened portion of the heart valve prosthesis 300 near the second end 310. When using the retainer 2820 shown of FIGS. 28-34, the heart valve prosthesis 300 may include three (3) connectors 322, a first connector 322A, a second connector 322B, and a third connector 322C. The first connector 322A includes a stem 324A with a first length LI, the second connector 322B includes a stem 324B with a second length L2, and the third connector 322C includes a stem 324C with a third length L3 as measured from the endmost crown 318 at the second end 310 of the heart valve prosthesis 300. In embodiments herein, the first length LI is less than the second length L2, and the second length L2 is less than the third length L3. The first connector 322A, the second connector 322B, and the third connector 322C are each configured to be disposed within a corresponding portion of the body portion 1732, adjacent to and between the corresponding first portions 2843A / 2857A, second portions 2843B / 2857B, and third portions 2843C / 2857C, respectively of the retainer 2820.

[0131] FIGS. 32-34 are flattened illustrations of the second end 310 of the heart valve prosthesis 300 and the plurality of connectors 322 of the heart valve prosthesis 300 at a different points in time during the sequential release of the heart valve prosthesis 300 from the retainer 2820. FIG. 32 shows the heart valve prosthesis 300 in situ, prior to release, that is, with the outer sheath 202 of the catheter 200 covering the retainer 2820 and the connectors 322. The paddles 325A, 325B, 325C of the plurality of connectors 322A, 322B, 322C, respectively, of the heart valve prosthesis 300 are disposed within the body portion 1732 of the retainer 2820 of the delivery catheter 200 and each stem 324A, 324B, 324C of the connectors 322 is disposed within the corresponding opening 1758A, 1758B, 1758C, respectively, of the distal shoulder portion 1734. Each connector 322 is retained in the retainer 2820 by the outer sheath 202 to releasably couple the heart valve prosthesis 300 to the delivery catheter 200.

[0132] To release the heart valve prosthesis 300 at the desired location, the outer sheath 202 is proximally retracted relative to the retainer 2820. As described previously with respect to FIG. 21A and the retainer 1720, the connectors 322 are disposed in the retainer 2220 and prevent longitudinal movement of the heart valve prosthesis 300 relative to theinner shaft 208. As the outer sheath 202 is proximally retracted, and travels proximally over the heart valve prosthesis 300, the exposed portions of the heart valve prosthesis 300 are released and begin to radially self-expand. The heart valve prosthesis 300 self-expands from the first end 308 to the second end 310. The outer sheath 202 proximally retracts over the retainer 2220 and the stepped shoulder or first surface 2843 of the retainer 2820 permits the sequential or staggered release of each connector 322 from the retainer 2820.

[0133] As shown in FIG. 33, as the outer sheath 202 is proximally retracted, the outer sheath 202 first passes proximally past the first connector 322A, thereby releasing the first connector 322A. At this point in the sequential release of the heart valve prosthesis 300, the outer sheath 202 is still disposed such that the outer sheath 202 covers at least a portion of the second connector 322B and the third connector 322C such that the second connector 322B and the third connector 322C remain releasably coupled to the retainer 2820. When the first connector 322 A is released, the first connector 322 A and a portion of the heart valve prosthesis 300 begin to radially expand. As the outer sheath 202 is further retracted, the outer sheath passes proximally past the second connector 322B, thereby releasing the second connector 322B, as shown in FIG. 34. The outer sheath 202 is still disposed such that the distal end of the outer sheath 202 covers at least portion of the third connector 322C such that the third connector 322C remains releasably coupled to the retainer 2820. When the outer sheath 202 is further retracted, the outer sheath passes proximally past the third connector 322C, thereby releasing the third connector 322C. When the third connector 322C is released, the plurality of connectors 322A, 322B, 322C are fully released and the heart valve prosthesis 300 may fully deploy to the radially expanded configuration.

[0134] Although FIGS. 22-27 and FIGS. 28-34 illustrate embodiments of retainers with two and three sequential or stepped releases of a heart valve prosthesis, respectively, this is not meant to be limiting, and embodiments with more than a three-step sequential release may be utilized.

[0135] FIGS. 35-39 show a spindle or retainer 2920 with improved release characteristics according to another embodiment hereof. The retainer 2920 is similar to the retainer shown in FIGS. FIG. 4-5 and 9-11 except as described herein. Therefore, all of the details described above are incorporated into the description of FIGS. 35-39 and the same or similar reference numerals are used. Thus, as described above, the retainer 2920 includesthe proximal end 224, the distal end 226, and the lumen 222. The retainer 2920 further includes the proximal portion 230, the body portion 232, the distal shoulder portion 234, and the collar 236. The retainer 2920 is configured to be used with a delivery catheter, for example the delivery catheter 200 previously described, to releasably couple the delivery catheter 200 to a heart valve prosthesis, for example the heart valve prosthesis 300 shown in FIG. 6, for delivery to and deployment at a desired treatment location.

[0136] However, the retainer 2920 differs from the retainer 220 in that instead of the proximal portion 230 being a continuous radially raised wall portion as compared to the body portion 232, the proximal portion 230 is discontinuous around the circumference of the retainer 2920. In other words, the proximal portion 230 of the retainer 2920 includes a plurality of proximal wall openings 2937 extending longitudinally therethrough. The retainer 2920 also differs from the retainer 2220 in that the distal shoulder portion 234 is also discontinuous between the openings 258. In other words, the distal shoulder portion 234 includes a plurality of distal shoulder openings 2959 extending longitudinally therethrough between the openings 258.

[0137] Stated another way, in the embodiment of FIGS. 35-39, the retainer 2920 includes an outer surface 2946 that is substantially cylindrical. At each location wherein a connector of a heart valve prosthesis is to be coupled to the retainer, i.e. a retention area 2932A or 2932B, the retainer 2920 includes a proximal wall or ledge 2930A and two distal walls or ledges 2934A, 2934B. The proximal ledge 2930A is a raised surface as compared to the outer surface 2946. The distal ledges 2934A, 2934B are raised surfaces as compared to the outer surface 2946 and are separated circumferentially to define the opening 258 therebetween. In the embodiment shown in FIGS. 35-39, there are two proximal ledges 2930A, 2930B disposed opposite each other and two sets of two distal ledges 2934A, 2934B 2934C, 2934D disposed opposite each other, to define two retention areas 2932A, 2932B. Each retention areas 2932A, 2932B is defined between one of the proximal ledges 2930A, 2930B and a respective pair of the distal ledges 2934A, 2934B, 2934C, 2934D. However, this is not meant to be limiting, and there may be more or fewer retention areas, such as one retention area, or three retention areas, or four or more retention areas.

[0138] Referring to FIG. 36A, each proximal wall opening 2937 extends radially inward from the outer surface 238 of the proximal portion 230 such that an outer surface 2939 ofeach proximal wall opening 2937 has a seventh radius R7 measured from the central longitudinal axis CLA of the retainer 2920 to the outer surface 2939 of the proximal wall opening. In embodiments herein, the seventh radius R7 is equal to the second radius R2 of the outer surface 246 of the body portion 232. Thus, the outer surface 2939 of each proximal wall opening 2937 is level with the outer surface 246 of the body portion 232. As noted above, the retainer 2920 includes proximal wall openings 2937 equal to the number of retention areas 2932.

[0139] As explained above, in the embodiment of FIGS. 35-39, the distal shoulder portion 234 includes the distal shoulder openings 2959. Referring to FIG. 36A, each distal shoulder opening 2929 extends radially inward from the outer surface 252 of the distal shoulder portion 234 such that an outer surface 2961 of each distal shoulder opening 2959 has an eighth radius R8 measured from the central longitudinal axis CLA of the retainer 2920 to the outer surface 2961 of the distal shoulder opening 2959. In embodiments herein, the eighth radius R8 is equal to the second radius R2 of the outer surface 246 of the body portion 232. Thus, the outer surface 2961 of each distal shoulder opening 2959 is level with the outer surface 246 of the body portion 232. Each stem opening 258 for the stem of a connector of a heart valve prosthesis is separated from the adjacent distal shoulder opening 2959 by a circumferential segment of the distal shoulder portion 234, which are the distal ledges 2934A, 2934B. 2934C, 2934D described above. In embodiments herein, the retainer 2920 includes distal shoulder openings 2959 equal to the number of retention areas 2932.

[0140] In embodiments herein, the body portion 232 and the collar 236 of FIGS. 35-39 are the same as the body portion 232 and the collar 236 described previously with FIGS. 4- 5. Therefore, details of the body portion 232 and the collar 236 of the retainer 2920 will not be repeated here.

[0141] It is noted that the proximal ledges 2930A, 2930B of the proximal portion 230 shown in FIGS. 35-39 include the curved section 242 described above with respect to the embodiments of FIGS. 4-5 and 12-13. However, this is not meant to be limiting, and the proximal ledges 2930A, 2930B of the proximal portion 230 may not include the curved section 242 as described above with respect to the embodiments of FIGS. 17-19, 22-24, and 28-30.

[0142] FIG. 37 is a perspective view of the retainer 2920 of the delivery catheter 200 with the connector 322 of the heart valve prosthesis 300 disposed therein. The connector 322 is disposed within the retention area 2932A of the body portion 232 of the retainer 2920. The stem 324 of the connector 322 is disposed within the corresponding stem opening 258 of the distal shoulder portion 234 of the retainer 2920 and the third edge 330 of the paddle 325 of the connector 322 is disposed adjacent to the curved section 242 of the proximal portion 230 of the retainer 2920. With the outer sheath 202 disposed over the retainer 2920 and the connector 322, the outer sheath 202 retains the connector 322 within the retention area 2932A of the body portion 232 of the retainer 2920 to releasably couple the connector 322 to the retainer 2920 and accordingly, the heart valve prosthesis 300 to the delivery catheter 200. Each connector 322 is longitudinally constrained within the body portion 232 of the retainer 2920 by the proximal portion 230 / proximal ledge 2930 and the distal shoulder portion 234 / distal ledges 2934 of the retainer 2920, and radially or compressively restrained by the outer sheath 202 as described previously with respect to FIG. 9.

[0143] FIGS. 38-39 show the release of the heart valve prosthesis 300 from the delivery catheter 200. FIG. 38 shows the second end 310 of the heart valve prosthesis 300 in the radially compressed configuration within the outer sheath 202 and releasably coupled to the retainer 2920 of the delivery catheter 200. Prior to the deployment of the heart valve prosthesis 300 in situ, as shown in FIG. 38, the paddles 325 of the plurality of connectors 322 of the heart valve prosthesis 300 are disposed within the retention areas 2932 of the body portion 232 of the retainer 2920 of the delivery catheter 200. Each connector 322 is retained in the retainer 2920 by the outer sheath 202 to releasably couple the heart valve prosthesis 300 to the delivery catheter 200. To release the heart valve prosthesis 300 at the desired treatment location, the outer sheath 202 is proximally retracted relative to the retainer 2920 and the heart valve prosthesis 300. As the outer sheath 202 is retracted, the heart valve prosthesis 300 distal of the retainer 2920 radially expands. As long as the connectors 322 are coupled to the retainer 2920, the outer sheath 202 may be advanced distally to recapture the heart valve prosthesis 300. During retraction of the outer sheath 202, friction between the heart valve prosthesis 300 and the outer sheath 202 tends to draw the heart valve prosthesis 300 in a proximal direction relative to the retainer 2920. The connectors 322 disposed in retainer 2920 prevent longitudinal movement of the heart valveprosthesis 300 relative to the inner shaft 208. In particular, the third edge 330 of the paddle 325 of each connector 322 abuts proximal ledges 2930A, 2930B of the proximal portion 230 of the retainer 2920, thereby preventing proximal movement of the heart valve prosthesis 300. As the outer sheath 202 travels proximally over the heart valve prosthesis 300, the exposed portions of the heart valve prosthesis 300 are released and begin to radially self-expand. The heart valve prosthesis 300 self-expands from the first end 308 to the second end 310. As the outer sheath 202 proximally retracts over the retainer 2920, the connectors 322 begin to release from the retainer 2920, as previously shown in FIG. 11 with the retainer 220. When the outer sheath 202 of the delivery catheter 200 is retracted past the body portion 232 of the retainer 2920, the connectors 322 are fully released and the heart valve prosthesis 300 may fully deploy to the radially expanded configuration. The inventors have found that utilizing a retainer with an open-sided pocket reduces or eliminates paddle / connector hang up, thereby improving release of the heart valve prosthesis 300 from the delivery catheter 200. Thus, if the connector 322 becomes twisted during release from the retainer 2920, the connector 322 may escape the pocket of the retainer 2920 through the open side of the retention area 2932A, as illustrated by the arrow ARI in FIG. 39. Upon movement out of the retention area 2932A, the connector 322 may move longitudinally proximally through the proximal wall opening 2937 or distally through the distal shoulder opening 2959. It is understood that in FIG. 39, additional components of the heart valve prosthesis 300 distal of the connector 322 have been intentionally omitted for the sake of clarity.

[0144] In embodiments, the transition or edge between surfaces of the retainer may be curved or smoothed to improve the loading and release of a heart valve prosthesis 300 from the retainer. In a non-limiting example, a transition from the shoulder or surface 243 within the curved section 242 to the outer surface 238 of the proximal portion 230 may be smoothed or curved. In another non-limiting example, a transition of the proximal shoulder or surface 257 of the body portion 232 to the outer surface 252 of the distal shoulder portion 234 at the proximal end 254 of the distal shoulder portion 234 may be smoothed or curved.

[0145] FIGS. 40-4 IB show a spindle or retainer 3020 with improved release characteristics according to another embodiment hereof. The retainer 3020 utilizes the proximal portion 230 of the embodiment of FIGS. 4-5 and the distal shoulder portion 234 of FIGS. 35-39. Thus, all of the details described above with respect to FIGS. 4-5 areincorporated into the description of FIGS. 40-4 IB, except for the description of the distal shoulder portion 234 for which the details described above with respect to FIGS. 35-39 are incorporate into the description of FIGS. 40-41B. Thus, generally, as described above, the retainer 3020 includes the proximal end 224, the distal end 226, the lumen 222, the proximal portion 230, the body portion 232, the distal shoulder portion 234, and the collar 236. The distal shoulder portion 234 of the retainer 3020 includes the plurality of stem openings 258 and the distal plurality of distal should openings 2959, as described above with respect to FIGS. 35-39. In other words, as described above, the distal shoulder portion 234 includes the distal ledges 2934A, 2934B, 2934C, 2934D.

[0146] Further, in the embodiment of FIGS. 40-41B, the proximal portion 230 of the retainer 3020 is the same as the proximal portion 230 of the retainer 220 of FIGS. 4-5. Thus, the tapered outer surface 238 of the proximal portion 230 extends circumferentially around the retainer 3020 as described previously, and details of the proximal portion 230 will not be repeated here.

[0147] The body portion 232, the distal shoulder portion 234, and the collar 236 of the retainer 3020 are the same as the body portion 232, the distal shoulder portion 234, and the collar 236 of the retainer 2920 of FIGS. 35-39. Therefore, details of the body portion 232, the distal shoulder portion 234, and the collar 236 of the retainer 3020 are not repeated here.

[0148] The release of the heart valve prosthesis 300 from the delivery catheter 200 with the retainer 3020 is the same as for the delivery catheter 200 with the retainer 2920, as described previously except that proximal longitudinal movement when the connector exits the retention area 2932 is prevented by the proximal portion 230. Thus, the delivery catheter 200 with the retainer 3020 reduces or eliminates paddle / connector hang up, thereby improving release of the heart valve prosthesis 300 from the delivery catheter 200.

[0149] While different embodiments have been described herein with specific attributes, this is not meant to be limiting, and the curved sections of FIGS. 4-5 and FIGS. 9-16, the protrusions of FIGS. 12-15, and the stepped first surface of FIGS. 22-34 may be utilized in any embodiment herein, and in any combination.

[0150] 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 withoutdeparting 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.

[0151] The following examples are illustrative of the techniques described herein.

[0152] Example 1. A retainer for a delivery system for delivering a heart valve prosthesis, the retainer comprising: a generally tubular body comprising: a proximal portion; a distal portion; a body portion extending between the proximal portion and the distal portion, wherein the body portion is recessed as compared to the proximal portion and the distal portion such that a proximal shoulder is defined at a proximal end of the body portion and a distal shoulder is defined at a distal end of the body portion, wherein the body portion is configured to receive a connector of the heart valve prosthesis, and wherein the body portion is pocketless such that the body portion does not include walls extending from the proximal shoulder to the distal shoulder; and a stem opening extending longitudinally through the distal portion, the stem opening configured to receive a portion of the connector of the heart valve prosthesis; and a lumen extending longitudinally through the body, the lumen configured to receive a shaft of the delivery system.

[0153] Example 2. The retainer of Example 1, wherein the proximal shoulder includes a curved portion curving proximally and aligned with the opening through the distal portion such that the body portion is configured to receive the connector of the heart valve prosthesis between the opening and the curved portion.

[0154] Example 3. The retainer of Example 1 or Example 2, wherein the distal portion of the retainer further includes a collar extending distally of the distal shoulder.

[0155] Example 4. The retainer of Example 3, further comprising a plurality of protrusions extending radially outwardly from the collar, the plurality of protrusions configured to receive endmost crowns of the heart valve prosthesis.

[0156] Example 5. The retainer of any one of Examples 1 to 4, wherein the retainer comprises a plurality of stem openings through the distal shoulder.

[0157] Example 6. The retainer of any one of Examples 1 to 4, wherein the retainer comprises two stem openings through the distal shoulder, wherein the two stem openings are disposed 180 degrees apart around a circumference of the retainer.

[0158] Example 7. The retainer of any one of Examples 1 to 4, wherein the retainer comprises two stem openings through the distal shoulder, wherein the two stem openings are not disposed 180 degrees apart around a circumference of the retainer.

[0159] Example 8. The retainer of any one of Examples 5 to 7, wherein the proximal shoulder includes a plurality of curved portions curving proximally and aligned with a corresponding stem opening of the plurality of stem openings through the distal portion such that the body portion is configured to receive a corresponding connector of a plurality of connectors of the heart valve prosthesis between each stem opening and each curved portion.

[0160] Example 9. The retainer of any one of Examples 1 to 8, wherein the distal shoulder is stepped circumferentially such that a first stem opening of the plurality of stem openings is longitudinally offset from a second stem opening of the plurality of stem openings.

[0161] Example 10. The retainer of any one of Examples 1 to 9, wherein the proximal shoulder is stepped circumferentially.

[0162] Example 11. The retainer of any one of Examples 1 to 10, wherein the retainer comprises a plurality of proximal wall openings through the proximal shoulder.

[0163] Example 12. The retainer of any one of Examples 1 to 11, wherein the retainer comprises two proximal wall openings through the proximal shoulder, wherein the two proximal wall openings are disposed opposite each other around a circumference of the retainer.

[0164] Example 13. The retainer of any one of Examples 1 to 12, wherein the retainer comprises a plurality of distal shoulder openings through the distal shoulder.

[0165] Example 14. The retainer of any one of Examples 1 to 13, wherein the retainer comprises two distal shoulder openings through the distal shoulder, wherein the two distal shoulder openings are disposed altematingly with the stem openings.

[0166] Example 15. A delivery system for delivering a heart valve prosthesis to treatment location, the delivery system comprising: a heart valve prosthesis having a first end and a second end, wherein the heart valve prosthesis includes a connector extending from the second end of the heart valve prosthesis; and a delivery catheter configured to percutaneously deliver the heart valve prosthesis, the delivery catheter including: an outer sheath having a distal portion configured to compressively restrain the heart valve prosthesisduring delivery; a middle member disposed within an outer sheath lumen of the outer sheath; and an inner shaft disposed within a middle member lumen of the middle member, the inner shaft having a distal portion configured to receive the heart valve prosthesis; a retainer coupled to a distal portion of the middle member, the retainer configured to receive the connector of the heart valve prosthesis to releasably couple the heart valve prosthesis to the delivery catheter, the retainer including: a proximal shoulder; a distal shoulder; and a body portion disposed between the proximal shoulder and the distal shoulder, wherein in a delivery configuration, the connector of the heart valve prosthesis is disposed in the body portion of the retainer, wherein the body portion is pocketless.

[0167] Example 16. The delivery system of Example 15, wherein the body portion of the retainer is recessed as compared to the proximal shoulder and the distal shoulder, wherein the body portion does not include walls extending from the proximal shoulder to the distal shoulder.

[0168] Example 17. The delivery system of Example 15 or Example 16, wherein the proximal shoulder includes a curved portion curving proximally, and wherein in the delivery configuration, the curved portion is aligned with a proximal end of the connector of the heart valve prosthesis.

[0169] Example 18. The delivery system of any one of Examples 15 to 17, wherein the retainer further includes a collar extending distally of the distal shoulder.

[0170] Example 19. The delivery system of Example 18, wherein the retainer further comprises a plurality of protrusions extending radially outwardly from the collar, wherein in the delivery configuration, endmost crowns of the second end of the heart valve prosthesis are looped around the protrusions.

[0171] Example 20. The delivery system of any one of Examples 15 to 19, wherein the retainer further comprises a stem opening extending longitudinally through the distal shoulder, wherein in the delivery configuration, a stem of the connector extends through the stem opening.

[0172] Example 21. The delivery system of any one of Examples 15 to 29, wherein the heart valve prosthesis includes a plurality of connectors, wherein the retainer comprises a plurality of stem openings extending longitudinally through the distal shoulder, and whereinin the delivery configuration, a corresponding stem of each connector extends through a corresponding stem opening of the plurality of stem openings.

[0173] Example 22. The delivery system of Example 21, wherein the retainer comprises two stem openings through the distal shoulder, wherein the two stem openings are disposed 180 degrees apart around a circumference of the retainer.

[0174] Example 23. The delivery system of Example 21, wherein the retainer comprises two stem openings through the distal shoulder, wherein the two stem openings are not disposed 180 degrees apart around a circumference of the retainer.

[0175] Example 24. The delivery system of any one of Examples 15 to 23, wherein the proximal shoulder includes a plurality of curved portions curving proximally, wherein the heart valve prosthesis includes a plurality of connectors, and wherein in the delivery configuration, each curved portion of the retainer is aligned with a corresponding connector of the heart valve prosthesis.

[0176] Example 25. The delivery system of any one of Examples 15 to 24, wherein the proximal shoulder is stepped circumferentially.

[0177] Example 26. The delivery system of any one of Examples 15 to 25, wherein the distal shoulder is stepped circumferentially.

[0178] Example 27. The delivery system of any one of Examples 15 to 26, wherein the retainer comprises a plurality of proximal wall openings through the proximal shoulder.

[0179] Example 28. The delivery system of any one of Examples 15 to 28, wherein the retainer comprises two proximal wall openings through the proximal shoulder, wherein the two proximal wall openings are disposed opposite each other around a circumference of the retainer.

[0180] Example 29. The delivery system of any one of Examples 15 to 28, wherein the retainer comprises a plurality of distal shoulder openings through the distal shoulder.

[0181] Example 30. The delivery system of any one of Examples 15 to 29, wherein the retainer comprises two distal shoulder openings through the distal shoulder, wherein the two distal shoulder openings are disposed altematingly with the stem openings around a circumference of the retainer.

Claims

WHAT IS CLAIMED IS:

1. A retainer (220, 1220, 1720, 2220, 2820, 2920, 3020) for a delivery system for delivering a heart valve prosthesis, the retainer comprising: a generally tubular body comprising: a proximal portion (230, 1730); a distal portion (234, 1734); a body portion (232, 1732) extending between the proximal portion and the distal portion, wherein the body portion is recessed as compared to the proximal portion and the distal portion such that a proximal shoulder (243, 1743) is defined at a proximal end of the body portion and a distal shoulder (257, 1757) is defined at a distal end of the body portion, wherein the body portion is configured to receive a connector of the heart valve prosthesis, and wherein the body portion is pocketless such that the body portion does not include walls extending from the proximal shoulder to the distal shoulder; and a stem opening (258, 1758) extending longitudinally through the distal portion, the stem opening configured to receive a portion of the connector of the heart valve prosthesis; and a lumen (222, 1722) extending longitudinally through the body, the lumen configured to receive a shaft of the delivery system.

2. The retainer of claim 1, wherein the proximal shoulder (243) includes a curved portion (242) curving proximally and aligned with the stem opening (258) through the distal portion (234) such that the body portion (232) is configured to receive the connector of the heart valve prosthesis between the stem opening (258) and the curved portion (242).

3. The retainer of claim 1 or claim 2, wherein the distal portion (234, 1734) of the retainer further includes a collar (236, 1736) extending distally of the distal shoulder (257, 1757).

4. The retainer of claim 3, further comprising a plurality of protrusions (1268) extending radially outwardly from the collar (236, 1736), the plurality of protrusions configured to receive endmost crowns of the heart valve prosthesis.

5. The retainer of any one of claims 1 to 4, wherein the retainer comprises a plurality of stem openings (258, 1758) through the distal shoulder (257, 1737).

6. The retainer of any one of claims 1 to 4, wherein the retainer comprises two stem openings through the distal shoulder, wherein the two stem openings (258) are disposed 180 degrees apart around a circumference of the retainer.

7. The retainer of any one of claims 1 to 4, wherein the retainer comprises two stem openings (1758 A, 1758B) through the distal shoulder, wherein the two stem openings are not disposed 180 degrees apart around a circumference of the retainer.

8. The retainer of any one of claims 5 to 7, wherein the proximal shoulder (242) includes a plurality of curved portions (243) curving proximally and aligned with a corresponding stem opening (258) of the plurality of stem openings through the distal portion such that the body portion is configured to receive a corresponding connector of a plurality of connectors of the heart valve prosthesis between each stem opening and each curved portion.

9. The retainer of any one of claims 1 to 8, wherein the distal shoulder (2257) is stepped circumferentially such that a first stem opening (1758 A) of the plurality of stem openings is longitudinally offset from a second stem opening (1758B) of the plurality of stem openings.

10. The retainer of any one of claims 1 to 9, wherein the proximal shoulder (2243, 2843) is stepped circumferentially.

11. The retainer of any one of claims 1 to 10, wherein the retainer comprises a plurality of proximal wall openings (2943) through the proximal shoulder (247).

12. The retainer of any one of claims 1 to 11, wherein the retainer comprises two proximal wall openings (2937) through the proximal shoulder, wherein the two proximal wall openings are disposed opposite each other around a circumference of the retainer.

13. The retainer of any one of claims 1 to 12, wherein the retainer comprises a plurality of distal shoulder openings (2959) through the distal shoulder.

14. The retainer of any one of claims 1 to 13, wherein the retainer comprises two distal shoulder openings (2959) through the distal shoulder, wherein the two distal shoulder openings are disposed altematingly with the stem openings (258).

15. A delivery system (100) for delivering a heart valve prosthesis (300) to treatment location, the delivery system comprising: a heart valve prosthesis (300) having a first end and a second end, wherein the heart valve prosthesis includes a connector (322) extending from the second end of the heart valve prosthesis; and a delivery catheter (200) configured to percutaneously deliver the heart valve prosthesis, the delivery catheter including: an outer sheath (202) having a distal portion configured to compressively restrain the heart valve prosthesis during delivery; a middle member (206) disposed within an outer sheath lumen of the outer sheath; an inner shaft (208) disposed within a middle member lumen of the middle member, the inner shaft having a distal portion configured to receive the heart valve prosthesis; and a retainer (220, 1220, 1720, 2220, 2820, 2920, 3020) according to any one of claims 1 to 14 coupled to a distal portion of the middle member, the retainer configured to receive the connector of the heart valve prosthesis to releasably couple the heart valve prosthesis to the delivery catheter.

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