Mechanically expanding heart valve and delivery apparatus therefor

Patent metadata

Field	Value
Publication number	US-12364598-B2
Application number	US-202418582897-A
Country	US
Kind code	B2
Filing date	Feb 21, 2024
Priority date	Dec 6, 2016
Publication date	Jul 22, 2025
Grant date	Jul 22, 2025

Abstract

A method can comprise deploying a prosthetic valve with a delivery apparatus, where the prosthetic valve comprises a frame and a rotatable screw connected to the frame, and where the screw comprises a screw head having an annular bore with internal threads. The delivery apparatus is releasably coupled to the screw and can comprise a first shaft and a first head disposed at an end of the first shaft, the first head comprising external threads releasably engaged 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 releasably engaged with an exterior surface of the screw head. Deploying the valve includes radially expanding the prosthetic valve by rotating the screw with the delivery apparatus.

First claim

What is claimed is:

1. A method comprising:
deploying a prosthetic valve with a delivery apparatus, wherein the prosthetic valve comprises a 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 delivery apparatus is 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 releasably engaged 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 releasably engaged with an exterior surface of the screw head,
wherein the deploying includes radially expanding the prosthetic valve by rotating the screw with the delivery apparatus.

2. The method of claim 1 , wherein the second head has an opening in which the screw head is received, 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 method of claim 2 , wherein the second head comprises a continuously curved exterior surface.

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

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

6. The method of claim 1 , further comprising, after the prosthetic valve is deployed, releasing the prosthetic valve from the delivery apparatus by rotating the first shaft relative to the second shaft to release the first shaft from the screw.

7. The method of claim 6 , wherein radially expanding the prosthetic valve comprises rotating the second shaft and the second head together to rotate the screw.

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

9. The method of claim 1 , wherein radially expanding the prosthetic valve by rotating the screw with the deliver apparatus includes rotating the second shaft to rotate the screw and radially expand the prosthetic valve.

10. A method comprising:
radially expanding a prosthetic valve with a delivery apparatus, the 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 engaged 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 engaged with internal threads disposed on an annular bore of the screw head, and wherein the second shaft is rotatable relative to the first shaft,

wherein radially expanding the prosthetic valve includes rotating together the first shaft and the second shaft to rotate the screw to radially expand the frame from a radially compressed state to a radially expanded state.

11. The method of claim 10 , further comprising actuating a handle of the delivery apparatus to radially expand the prosthetic valve, wherein a proximal end of the assembly is connected to the handle.

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

13. The method 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 method of claim 10 , wherein the screw is coaxial with the first shaft and the second shaft.

15. A method comprising:
radially expanding a prosthetic valve with a delivery apparatus, the 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 by the delivery apparatus, the delivery apparatus comprising:
a first member comprising threads disposed on a distal end portion thereof that forms 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 that forms a second releasable connection with the head of the screw, wherein the first member and the second member are coaxial with the screw,

wherein radially expanding the prosthetic valve with the delivery apparatus includes rotating together the first member and second member to rotate the screw, thereby radially expanding the frame from a radially compressed state to a radially expanded state.

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

17. The method 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 method of claim 15 , wherein the first member extends coaxially through the second member.

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

20. The method of claim 15 , wherein the distal end portion of the second member comprises an interior surface defining an opening that receives 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