Prosthetic valve holders with automatic deploying mechanisms

• US 10,463,485 B2
• Filed: 04/06/2017
• Issued: 11/05/2019
• Est. Priority Date: 04/06/2017
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Conklin, Brian S., Murad, Michael C.
• Primary Examiner(s): Tyson, Melanie R
• Application Number:
  US15/481,283
• Publication Number:
  US 20180289477A1
• Time in Patent Office: 943 Days
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type

Abstract

A valve holder for delivering a prosthetic heart valve to an implant site is in various embodiments configured to reduce or eliminate the occurrence of suture looping or other damage to the prosthetic valve during implantation. The valve holder can be configured to deploy or actuate automatically when performing preparatory steps that are already familiar to practitioners, such as attaching a delivery handle to the valve holder, so that the valve holders will not require additional steps or training to use. Therefore, operation of the valve holders is kept simple, and occurrences of mistakes caused by user error can be minimized or reduced. Valve holders according to different embodiments can be designed to accommodate implantation of prosthetic heart valves from either the inflow end or the outflow end of the native valve annulus.

Claims

1. A valve holder configured to be attached to a delivery handle and to a prosthetic heart valve comprising a plurality of commissure posts and a plurality of flexible leaflets connected to the commissure posts, the valve holder comprising:

a hub having a first end, a second end, and a central axis extending between the first and second ends, the hub comprising a first portion at the first end and a second portion extending from the first portion towards the second end, wherein a coaxial bore extends through the second portion of the hub, and wherein a first region of the bore has an engagement portion;

a post comprising a longitudinally extending central body configured to be positioned in the bore and to extend out of a side of the bore opposite the second end while at least part of the engagement portion remains accessible from outside the hub for directly engaging the delivery handle; and

a plurality of sutures configured to connect to and extend from the first end of the hub in a direction away from the second end of the hub and to engage respective commissure posts of the prosthetic heart valve, wherein the sutures form a crossing region on the central axis at a first distance from the first end of the hub;

wherein in a first configuration, the central body of the post extends into the first region of the bore and a first end of the post is at a first position that is spaced apart from the crossing region of the sutures; and

wherein in a second configuration, the post is positioned farther away from the second end of the hub, and the first end of the post is at a second position where the first end of the post engages the crossing region of the sutures and axially displaces the crossing region of the sutures away from the hub to inwardly deflect commissure posts of the prosthetic heart valve that are attached to the sutures.

2. The valve holder of claim 1, wherein the hub comprises three radially extending projections on which the sutures are configured to be attached.

3. The valve holder of claim 1, wherein a circumferentially extending gap is formed between the first and second portions of the hub, wherein the post further comprises a longitudinally extending tubular section extending from the first end of the post around the central body, and wherein the tubular section of the post is configured to extend through the gap.

4. The valve holder of claim 1, wherein at least one of the hub or the post comprises a latch for holding the valve holder in at least one of the first configuration or the second configuration.

5. The valve holder of claim 1, wherein the first region of the bore is positioned closer to the first end of the hub than a second region of the bore, and wherein the second region of the bore is configured to align the delivery handle with the first region of the bore.

6. The valve holder of claim 1, wherein the first end of the post has at least one groove configured to engage the crossing region of the sutures.

7. The valve holder of claim 1, further comprising one or more projections configured to guide movement between the hub and the post.

8. The valve holder of claim 1, wherein the first portion and the second portion of the hub are separate parts that are connected by one or more sutures.

9. The valve holder of claim 8, wherein one of the first portion or the second portion of the hub further comprises an interlock portion configured to engage the other one of the first portion or the second portion of the hub when the first and second portion of the hub are connected to one another.

10. The valve holder of claim 1, wherein the first end of the post has an axially extending hole for engagement with a pin during attachment of the prosthetic heart valve.

11. The valve holder of claim 1, wherein at least one of the hub or the post comprises an abutment for restricting further movement of the post in a direction away from the second end of the hub when the valve holder is in the second configuration.

12. The valve holder of claim 1, wherein the engagement portion of the valve holder comprises a thread.

13. A system for delivering a prosthetic heart valve comprising a plurality of commissure posts and a plurality of flexible leaflets connected to the commissure posts to an implant site, the system comprising:

a valve holder configured to be attached to the prosthetic heart valve, the valve holder comprising;

a hub having a first end, a second end, and a central axis extending between the first and second ends, the hub comprising a first portion at the first end and a second portion extending from the first portion towards the second end, wherein a coaxial bore extends through the second portion of the hub, and wherein a first region of the bore has an engagement portion;

a post comprising a longitudinally extending central body configured to be positioned in the bore and to extend out of a side of the bore opposite the second end while at least part of the engagement portion remains accessible from outside the hub for directly engaging the delivery handle; and

a plurality of sutures configured to connect to and extend from the first end of the hub in a direction away from the second end of the hub and to engage respective commissure posits of the prosthetic heart valve, wherein the sutures form a crossing region on the central axis at a first distance from the first end of the hub; and

a delivery handle configured to be attached to the valve holder for advancing the valve holder and the prosthetic heart valve to the implant site, the delivery handle comprising an engagement portion configured to engage the engagement portion at the first region of the bore of the valve holder;

wherein in a first configuration, the central body of the post extends into the first region of the bore and a first end of the post is at a first position that is spaced apart from the crossing region of the sutures; and

wherein when the engagement portions of the valve holder and the delivery handle are engaged, the delivery handle is configured to adjust the valve holder to a second configuration where the post is positioned farther away from the second end of the hub, and the first end of the post is at a second position where the first end of the post engages the crossing region of the sutures and axially displaces the crossing region of the sutures away from the hub to inwardly deflect commissure posts of the prosthetic heart valve that are attached to the valve holder sutures.

14. The system of claim 13, wherein the engagement portions of the valve holder and the delivery handle respectively comprise complementary threaded surfaces.

15. The system of claim 13, wherein when the valve holder has been adjusted to the second configuration by the delivery handle, the engagement portion of the holder body and the engaged delivery handle are detachable from other portions of the valve holder, while a latch on the other portions of the valve holder are configured to hold the valve holder in the deployed configuration.

16. A valve holder configured to be attached to a delivery handle and to a prosthetic heart valve comprising a plurality of commissure posts and a plurality of flexible leaflets connected to the commissure posts, the valve holder comprising:

a hub having a first end, a second end, and a central axis extending between the first and second ends, the hub comprising a first portion at the first end and a second portion extending from the first portion towards the second end, wherein a coaxial bore extends through the second portion of the hub, and wherein a first region of the bore has a thread for engaging the delivery handle;

a post comprising a longitudinally extending central body configured to be positioned in the bore and to extend at least partially into the first region of the bore; and

a plurality of sutures configured to connect to and extend from the first end of the hub in a direction away from the second end of the hub and to engage respective commissure posts of the prosthetic heart valve, wherein the sutures form a crossing region on the central axis at a first distance from the first end of the hub;

wherein in a first configuration, the central body of the post extends into the first region of the bore and a first end of the post is at a first position that is spaced apart from the crossing region of the sutures; and

wherein in a second configuration, the post is positioned farther away from the second end of the hub, and the first end of the post is at a second position where the first end of the post engages the crossing region of the sutures and axially displaces the crossing region of the sutures away from the hub to inwardly deflect commissure posts of the prosthetic heart valve that are attached to the sutures.

17. The valve holder of claim 16, wherein a circumferentially extending gap is formed between the first and second portions of the hub, wherein the post further comprises a longitudinally extending tubular section extending from the first end of the post around the central body, and wherein the tubular section of the post is configured to extend through the gap.

18. The valve holder of claim 16, wherein at least one of the hub or the post comprises a latch for holding the valve holder in at least one of the first configuration or the second configuration.

19. The valve holder of claim 16, wherein the thread is positioned closer to the first end of the hub than a second region of the bore, and wherein the second region of the bore is configured to align the delivery handle with the thread.

20. The valve holder of claim 16, wherein the first end of the post has at least one groove configured to engage the crossing region of the sutures.