Mechanically expanding heart valve and delivery apparatus therefor

Patent metadata

Field	Value
Publication number	US-12083012-B2
Application number	US-202217824411-A
Country	US
Kind code	B2
Filing date	May 25, 2022
Priority date	Dec 6, 2016
Publication date	Sep 10, 2024
Grant date	Sep 10, 2024

Abstract

An assembly can comprise a prosthetic valve comprising a radially expandable and compressible frame and a rotatable screw connected to the frame, where the screw comprises a screw head having an annular bore with internal threads, and where the screw is rotatable to radially expand the frame. The assembly further comprises a delivery apparatus releasably coupled to the screw, the delivery apparatus comprising a first shaft and a first head disposed at an end of the first shaft, the first head comprising external threads configured to engage with the internal threads of the screw head, and a second shaft that is coaxial with and surrounds the first shaft, the second shaft comprising a second head disposed at an end of the second shaft. The second head is configured to releasably engage with an exterior surface of the screw head and rotate the screw.

First claim

What is claimed is:

1. An assembly comprising:
a prosthetic valve comprising a radially expandable and compressible frame and a rotatable screw connected to the frame, wherein the screw comprises a screw head having an annular bore with internal threads, and wherein the screw is rotatable to radially expand the frame; and
a delivery apparatus releasably coupled to the screw, the delivery apparatus comprising:
a first shaft and a first head disposed at an end of the first shaft, the first head comprising external threads configured to engage with the internal threads of the screw head; and
a second shaft that is coaxial with and surrounds the first shaft, the second shaft comprising a second head disposed at an end of the second shaft, the second head configured to releasably engage with an exterior surface of the screw head and rotate the screw.

2. The assembly of claim 1 , wherein the second head has an opening configured to receive the screw head therein, and wherein the opening is defined by interior flat surfaces that correspond to a shape of exterior flat surfaces of the exterior surface of the screw head.

3. The assembly of claim 2 , wherein the second head comprises a continuously curved exterior surface.

4. The assembly of claim 2 , wherein the first head extends through and is rotatable within the opening of the second head.

5. The assembly of claim 1 , wherein the screw has an externally threaded surface.

6. The assembly of claim 1 , wherein the first shaft is rotatable relative to the second shaft to releasably engage with the internal threads of the screw head of the screw.

7. The assembly of claim 6 , wherein, when the external threads of the first head are engaged with the internal threads of the screw head, the second shaft and second head are rotatable to rotate the screw, to radially expand the frame.

8. The assembly of claim 1 , wherein the first shaft extends to a handle of the delivery apparatus and is rotatable via the handle.

9. The assembly of claim 1 , wherein the screw is coaxial with the first shaft and the second shaft, and wherein the screw is rotatable, via rotation of the second shaft, to radially expand the frame.

10. A delivery apparatus for implanting a prosthetic valve comprising a mechanically actuatable frame, the frame comprising a screw configured to be rotated, via rotation of a screw head thereof, the delivery apparatus comprising:
an assembly configured to be releasably coupled to the screw, the assembly comprising:
a first shaft comprising a first head comprising an opening formed by internal flat surfaces of the first head that are configured to engage with complementary flat surfaces on an exterior of the screw head; and
a second shaft disposed coaxially within the first shaft, the second shaft comprising a second head at its distal end comprising external threads that are configured to engage with internal threads disposed on an annular bore of the screw head, wherein the second shaft is rotatable relative to the first shaft, and wherein the first shaft and the second shaft are rotatable together to rotate the screw to radially expand the frame from a radially compressed state to a radially expanded state.

11. The delivery apparatus of claim 10 , further comprising a handle, and wherein a proximal end of the assembly is connected to the handle.

12. The delivery apparatus of claim 10 , wherein the first head comprises a continuously curved exterior surface.

13. The delivery apparatus of claim 10 , wherein the second head is mounted on the distal end of the second shaft, and wherein a base of the second head that is disposed proximal to the external threads of the second head is wider than the second shaft and shaped to fit within the first head.

14. The delivery apparatus of claim 10 , wherein the screw is coaxial with the first shaft and the second shaft.

15. A system comprising:
a prosthetic valve comprising a mechanically actuatable frame, the mechanically actuatable frame comprising at least one threaded screw, the threaded screw configured to be rotated, via rotation of a head thereof; and
a delivery apparatus comprising at least one assembly configured to rotate the screw, the assembly comprising:
a first member comprising threads disposed on a distal end portion thereof that are configured to form a first releasable connection with a threaded portion of the head of the screw; and
a second member that is concentric with the first member and has a distal end portion configured to form a second releasable connection with the head of the screw, wherein the first member and the second member are coaxial with the screw and rotatable together to rotate the screw, wherein rotation of the screw is effective to radially expand the frame from a radially compressed state to a radially expanded state.

16. The system of claim 15 , wherein the distal end portion of the second member has a shape that is configured to mate with and fit within or around a complementary-shaped portion of the head of the screw such that the second releasable connection is formed.

17. The system of claim 16 , wherein the shape of the distal end portion of the second member and the complementary-shaped portion of the head of the screw are a plurality of flat surfaces disposed around the distal end portion of the second member and the head of the screw, respectively.

18. The system of claim 15 , wherein the first member extends coaxially through the second member.

19. The system of claim 18 , wherein the threads of the first member are external threads that are configured to mate with internal threads of an annular bore of the head of the screw.

20. The system of claim 15 , wherein the distal end portion of the second member comprises an interior surface defining an opening configured to receive the head of the screw therein, the interior surface comprising a plurality of flat surfaces, the plurality of flat surfaces having a complementary shape to a plurality of flat surfaces on an exterior surface of the head of the screw.

Assignees

• Edwards Lifesciences Corp

Inventors

• Maimon David
• Manash Boaz
• Leiba Eyal
• Yohanan Ziv
• Neumann Yair A
• Dvorsky Anatoly
• Bar-Or Jonathan
• Cohen Oren
• Witzman Ofir
• Tayeb Liron
• Schwarcz Elazar Levi
• Miller Noam
• Saar Tomer

Classifications

• A61F2/243 Primary

  Deployment by mechanical expansion · CPC title

• A61F2220/0041

  using additional screws, bolts, dowels or rivets, e.g. connecting screws · CPC title

• A61F2250/001

  for adjusting a diameter · CPC title

• A61F2250/0069

  Sealing means · CPC title

• A61F2/2418 Primary

  Scaffolds therefor, e.g. support stents · CPC title