Replacement heart valve implant with invertible leaflets

• US 10,201,416 B2
• Filed: 03/22/2017
• Issued: 02/12/2019
• Est. Priority Date: 05/16/2016
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Backus, Andrew J. H., Calomeni, Michael P.
• Primary Examiner(s): Stewart, Alvin
• Application Number:
  US15/466,005
• Publication Number:
  US 20170325938A1
• Time in Patent Office: 692 Days
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped

Abstract

A locking mechanism for a medical implant may include a buckle member, a post member axially translatable with respect to the buckle member, the post member including a receiving portion proximate a proximal end of the post member, a distal end, a laterally-arched central body portion extending between the receiving portion and the distal end, and a cantilevered leg extending proximally from the distal end, and an actuator element including a proximal shaft portion and a distal engagement portion, the distal engagement portion being configured to releasably engage the receiving portion of the post member. The proximal shaft portion may be pivotable with respect to the distal engagement portion.

Claims

1. A locking mechanism for a medical implant, comprising:

a buckle member;

a post member axially translatable with respect to the buckle member, the post member including a receiving portion proximate a proximal end of the post member, a distal end, a laterally-arched central body portion extending between the receiving portion and the distal end, and a cantilevered leg extending proximally from the distal end; and

an actuator element including a proximal shaft portion and a distal engagement portion, the distal engagement portion being configured to releasably engage the receiving portion of the post member;

wherein the proximal shaft portion is pivotable with respect to the distal engagement portion.

2. The locking mechanism of claim 1, wherein the actuator element includes a hinge element disposed between the proximal shaft portion and the distal engagement portion.

3. The locking mechanism of claim 1, wherein the post member includes at least one aperture extending therethrough proximate the distal end, the at least one aperture being configured to receive a coupling element therethrough.

4. The locking mechanism of claim 1, wherein the distal engagement portion includes a lateral protrusion proximate a distal end of the distal engagement portion.

5. The locking mechanism of claim 4, wherein the lateral protrusion is configured to engage with an aperture disposed within the receiving portion.

6. The locking mechanism of claim 1, wherein the laterally-arched central body portion includes a tooth extending laterally therefrom.

7. The locking mechanism of claim 6, wherein the tooth extends toward the cantilevered leg.

8. The locking mechanism of claim 6, wherein the central body portion arches laterally in a first direction relative to the proximal end and the distal end, and the tooth extends laterally in the first direction from the central body portion.

9. The locking mechanism of claim 1, wherein the cantilevered leg includes a longitudinally-oriented slot extending therethrough.

10. The locking mechanism of claim 1, wherein the receiving portion includes a first portion and a second portion configured to splay apart as the post member is translated proximally within the buckle member to release the distal engagement portion therefrom.

11. The locking mechanism of claim 1, wherein the buckle member is formed of a substantially rigid material.

12. The locking mechanism of claim 1, wherein the central body portion is configured to flex towards a substantially straight configuration upon proximal translation through the buckle member.

13. A replacement heart valve implant, comprising:

a tubular anchor member defining a central longitudinal axis;

a plurality of locking mechanisms, each locking mechanism comprising;

a buckle member fixedly attached to the tubular anchor member; and

a post member axially translatable with respect to the buckle member, the post member including a receiving portion proximate a proximal end of the post member, a distal end, a laterally-arched central body portion extending between the receiving portion and the distal end, and a cantilevered leg extending proximally from the distal end;

a plurality of valve leaflets, wherein each valve leaflet is coupled to the cantilevered leg of at least one of the plurality of locking mechanisms; and

a plurality of actuator elements corresponding to the plurality of locking mechanisms, each actuator element including a proximal shaft portion and a distal engagement portion, wherein the proximal shaft portion is pivotable relative to the distal engagement portion, wherein the distal engagement portion is releasably fixed to the receiving portion of one post member.

14. The replacement heart valve implant of claim 13, wherein the buckle member of each locking mechanism is positioned against an inner surface of the tubular anchor member.

15. The replacement heart valve implant of claim 13, wherein the plurality of valve leaflets is configured to shift between an everted position wherein a free end of each of the plurality of valve leaflets is disposed distally of the tubular anchor member, and a deployed position wherein the free end of each of the plurality of valve leaflets is disposed within the tubular anchor member.

16. The replacement heart valve implant of claim 15, wherein in the everted position, each of the plurality of actuator elements extends distally of the tubular anchor member.

17. The replacement heart valve implant of claim 15, wherein each of the plurality of valve leaflets is secured to the tubular anchor member at a secured end opposite the free end.

18. A replacement heart valve implant, comprising:

a tubular anchor member defining a central longitudinal axis, the tubular anchor member being configured to shift between a delivery configuration and a deployed configuration;

a plurality of locking mechanisms, each locking mechanism comprising;

a buckle member fixedly attached to the tubular anchor member; and

a post member axially translatable with respect to the buckle member, the post member including a receiving portion proximate a proximal end of the post member, a distal end, a laterally-arched central body portion extending from the receiving portion to the distal end, and a cantilevered leg extending proximally from the distal end;

a plurality of valve leaflets, wherein each valve leaflet is coupled to the cantilevered leg of at least one of the plurality of locking mechanisms, and

a plurality of actuator elements corresponding to the plurality of locking mechanisms, each actuator element including a proximal shaft portion pivotably connected to a distal engagement portion, the distal engagement portion being releasably fixed to the receiving portion of one post member, wherein the distal engagement portion is configured to pivot with respect to the proximal shaft portion in a radial direction relative to the central longitudinal axis.

19. The replacement heart valve implant of claim 18, wherein each actuator element extends through the buckle member of its corresponding locking mechanism when the tubular anchor member is in the delivery configuration, and each actuator element is configured to translate the post member of its corresponding locking mechanism into engagement with the buckle member of its corresponding locking mechanism upon proximal retraction of the plurality of actuator elements.

20. The replacement heart valve implant of claim 18, wherein the post member is at least partially disposed distally of the tubular anchor member when the tubular anchor member is in the delivery configuration, and the post member is locked within the buckle member when the tubular anchor member is in the deployed configuration.