Integrated heart valve delivery system

Patent metadata

Field	Value
Publication number	US-10010418-B2
Application number	US-201715676817-A
Country	US
Kind code	B2
Filing date	Aug 14, 2017
Priority date	Sep 8, 2006
Publication date	Jul 3, 2018
Grant date	Jul 3, 2018

Abstract

An assembly includes a prosthetic heart valve and a delivery apparatus for implanting the prosthetic heart valve within the native aortic valve of a patient. The prosthetic heart valve has a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent. The delivery apparatus has a handle, a first shaft having a proximal end portion and a distal end portion, a second shaft extending co-axially through the first shaft and having a proximal end portion and a distal end portion, the proximal end portions of the first and second shafts extending distally from the handle, a valve cover coupled to the distal end portion of the first shaft, and a nose piece coupled to the distal end portion of the second shaft.

First claim

We claim:

1. An assembly for replacing a native aortic valve comprising:
a prosthetic heart valve comprising a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent, the prosthetic heart valve comprising an inlet end portion and an outlet end portion; and
a delivery apparatus for implanting the prosthetic heart valve within the native aortic valve in the heart of a patient, the delivery apparatus comprising a handle, a first shaft having a proximal end portion and a distal end portion, a second shaft extending co-axially through the first shaft and having a proximal end portion and a distal end portion, the proximal end portions of the first and second shafts extending distally from the handle, a valve cover coupled to the distal end portion of the first shaft, and a nose piece coupled to the distal end portion of the second shaft;
wherein the distal end portion of the second shaft extends distally beyond the valve cover such that the nose piece is positioned distal to the valve cover;
wherein the second shaft comprises a lumen extending along its length, the lumen sized to receive a guidewire;
wherein the first and second shafts are moveable axially relative to each other to produce axial movement of the valve cover and the nose piece relative to the each other;
wherein the prosthetic heart valve is radially crimped around the second shaft with the inlet end portion retained within the nose piece and the outlet end portion retained within the valve cover;
wherein the nose piece comprises an interior bore and an abutment member disposed within the bore and having an abutment surface engaging the inlet end portion of the prosthetic heart valve to limit axial movement of the prosthetic heart valve within the bore of the nose piece.

2. The assembly of claim 1 , further comprising a retaining mechanism configured to selectively retain the second shaft from moving axially relative to the handle and the first shaft.

3. The assembly of claim 2 , wherein the retaining mechanism comprises a retaining pin.

4. The assembly of claim 1 , wherein when the valve cover is in a distal-most position and the nose piece is in a proximal-most position, a distal end of the valve cover abuts a proximal end of the nose piece such that the prosthetic heart valve is completely enclosed by the valve cover and the nose piece.

5. The assembly of claim 1 , wherein when the valve cover is in a distal-most position and the nose piece is in a proximal-most position, a distal end of the valve cover is spaced from a proximal end of the nose piece such that a portion of the prosthetic heart valve is left uncovered by the valve cover and the nose piece.

6. The assembly of claim 1 , wherein the prosthetic heart valve is self-expandable.

7. The assembly of claim 1 , wherein the second shaft is tensioned relative to the first shaft.

8. The assembly of claim 7 , further comprising a retaining mechanism configured to selectively retain the second shaft in tension relative to the first shaft.

9. The assembly of claim 8 , wherein the nose piece is held against the valve cover by the tension in the second shaft.

10. The assembly of claim 1 , wherein the abutment surface extends perpendicular to a longitudinal axis of the second shaft.

11. The assembly of claim 1 , wherein the nose piece comprises an outer layer and an reinforcing inner layer that is relatively stiffer than the outer layer.

12. The assembly of claim 1 , wherein the nose piece comprises a conical distal end portion.

13. An assembly for replacing a native aortic valve comprising:
a prosthetic heart valve comprising a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent, the prosthetic heart valve comprising an inlet end portion and an outlet end portion; and
a delivery apparatus for implanting the prosthetic heart valve within the native aortic valve in the heart of a patient, the delivery apparatus comprising a handle, a first shaft having a proximal end portion and a distal end portion, a second shaft extending co-axially through the first shaft and having a proximal end portion and a distal end portion, a third shaft extending co-axially through the first shaft and over the second shaft and having a proximal end portion and a distal end portion, the proximal end portions of the first, second, and third shafts extending distally from the handle, a valve cover coupled to the distal end portion of the first shaft, and a nose piece coupled to the distal end portion of the second shaft;
wherein the distal end portion of the second shaft extends distally beyond the valve cover such that the nose piece is positioned distal to the valve cover;
wherein the distal end portion of the third shaft extends into the valve cover;
wherein the second shaft comprises a lumen extending along its length, the lumen sized to receive a guidewire;
wherein the first shaft is moveable axially relative to the second shaft in a proximal direction to move the valve cover proximally relative to the nose piece;
wherein the second shaft is moveable axially relative to the first shaft in a distal direction to move the nose piece distally relative to the valve cover;
wherein the prosthetic heart valve is radially crimped around the second shaft with the inlet end portion retained within the nose piece and the outlet end portion retained within the valve cover;
wherein the delivery apparatus further comprises a manually-operable knob operatively coupled to the proximal end portion of the second shaft and configured to move the second shaft axially relative to the first shaft and the third shaft, and a retaining mechanism configured to selectively retain the second shaft from moving axially relative to the handle, the first shaft, and the third shaft.

14. The assembly of claim 13 , wherein the retaining mechanism comprises a retaining pin.

15. The assembly of claim 13 , wherein the retaining mechanism is configured to selectively retain the second shaft in tension relative to the first shaft.

16. The assembly of claim 15 , wherein the nose piece is held against the valve cover by the tension in the second shaft.

17. The assembly of claim 13 , further comprising an abutment member disposed inside the nose piece, wherein the inlet end portion of the prosthetic heart valve engages the abutment member.

18. The assembly of claim 17 , wherein the abutment member comprises an abutment surface that engages the inlet end portion of the prosthetic heart valve, wherein the abutment surface extends perpendicular to a longitudinal axis of the second shaft.

19. The assembly of claim 17 , further comprising an annular tapered wedge disposed in the valve cover.

20. An assembly for replacing a native aortic valve comprising:
a prosthetic heart valve comprising a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent, the prosthetic heart valve comprising an inlet end portion and an outlet end portion; and
a delivery apparatus for implanting the prosthetic heart valve within the native aortic valve in the heart of a patient, the delivery apparatus comprising a handle, a first shaft having a proximal end portion and a distal end portion, a second shaft extending co-axially through the first shaft and having a proximal end portion and a distal end portion, the proximal end portions of the first and second shafts extending distally from the handle, a valve cover coupled to th

Assignees

• Edwards Lifesciences Corp

Inventors

• Marchand Philippe
• Taylor David M
• Milich Robert
• Evans David J
• Chia Christopher
• Cayabyab Ronaldo
• Bowes Robert

Classifications

• A61M25/0045

  multi-layered, e.g. coated (coating materials A61L29/08) · CPC title

• A61M25/0136

  Handles therefor · CPC title

• A61F2/9517

  handle assemblies therefor · CPC title

• A61F2/2436

  Deployment by retracting a sheath · CPC title

• A61F2/2433 Primary

  using balloon catheter · CPC title