Integrated heart valve delivery system

• US 10,010,418 B2
• Filed: 08/14/2017
• Issued: 07/03/2018
• Est. Priority Date: 09/08/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Marchand, Philippe, Taylor, David M., Milich, Robert, Evans, David J., Chia, Christopher, Cayabyab, Ronaldo, Bowes, Robert
• Primary Examiner(s): Anderson, Gregory
• Application Number:
  US15/676,817
• Publication Number:
  US 20170360560A1
• Time in Patent Office: 323 Days
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 39/0613 with means for adjusting the seal opening or pressure A61M39/0693 takes precedence

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.

Claims

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 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 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 second shaft is placed in tension to hold a proximal end portion of the nose piece against a distal end portion of the valve cover.

21. The assembly of claim 20, wherein the delivery apparatus further comprises a manually-operable knob operatively coupled to the proximal end portion of the second shaft and configured to selectively retain the second shaft in tension.

22. 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, a nose piece coupled to the distal end portion of the second shaft, and an annular tapered wedge disposed in the valve cover;

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 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 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;

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 a retaining mechanism configured to selectively retain the second shaft from moving axially relative to the handle and the first shaft.

23. The assembly of claim 22, wherein the tapered wedge has a frusto-conical shape.

24. The assembly of claim 23, wherein the tapered wedge is movable relative to the valve cover in the proximal and distal directions.

25. The assembly of claim 22, wherein the tapered wedge has a first diameter at a proximal end thereof and tapers to a second, smaller diameter at a distal end thereof.