Methods and devices for delivery of prosthetic heart valves and other prosthetics

• US 8,403,981 B2
• Filed: 02/27/2006
• Issued: 03/26/2013
• Est. Priority Date: 02/27/2006
• Status: Expired due to Fees

• Current Assignee: AorTx, Inc. (Johnson & Johnson)
• Original Assignee: Cardiacmc Incorporated
• Inventors: Forster, David C., Heneveld, Scott, Walsh, Brandon, Beckey, Brian
• Primary Examiner(s): Woo, Julian
• Assistant Examiner(s): Templeton, Christopher L
• Application Number:
  US11/364,724
• Publication Number:
  US 20070203561A1
• Time in Patent Office: 2,584 Days
• Field of Search: 623/2.11, 623/1.11, 606/108, 128/898
• US Class Current: 623/2.11
• 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 2/2433 using balloon catheter
• 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 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

Prosthetic valves and their component parts are described, as are prosthetic valve delivery devices and methods for their use. The prosthetic valves are particularly adapted for use in percutaneous aortic valve replacement procedures. The delivery devices are particularly adapted for use in minimally invasive surgical procedures. The preferred delivery device includes a catheter having a deployment mechanism attached to its distal end, and a handle mechanism attached to its proximal end. A plurality of tethers are provided to selectively restrain the valve during deployment. A number of mechanisms for active deployment of partially expanded prosthetic valves are also described.

Claims

1. A method of using a delivery device for an expandable prosthetic heart valve, comprising:

percutaneously inserting a delivery device into a patient'"'"'s body, wherein the delivery device is coupled with an expandable prosthetic heart valve having a distal end and a proximal end, the delivery device comprising a plurality of retaining members and a plurality of elongate tethers positioned to allow manipulation of the expandable prosthetic heart valve;

expanding the expandable prosthetic heart valve from a contracted state to an expanded state;

increasing a tension on the plurality of tethers from a state where each elongate tether contacts both the distal end and the proximal end of the expandable prosthetic heart valve such that the expandable prosthetic heart valve is at least partially contracted towards a central, longitudinal axis of the delivery device;

advancing the plurality of retaining members in the same direction over the prosthetic heart valve after increasing the tension on the plurality of elongate tethers and prior to adjusting the position of the prosthetic heart valve;

adjusting the position of the expandable prosthetic heart valve while at least partially contracted; and

decreasing the tension on the plurality of elongate tethers after adjusting the position of the prosthetic heart valve.

2. The method of claim 1, wherein expanding the prosthetic heart valve comprises expanding the prosthetic heart valve into contact with a vessel wall of a blood vessel of the patient.

3. The method of claim 2, wherein the blood vessel is the aorta.

4. The method of claim 1, wherein the plurality of tethers are engaged with the prosthetic heart valve through a hole in a support structure of the prosthetic heart valve.

5. The method of claim 1, wherein the prosthetic heart valve comprises a support structure coupled with a valvular body, the support structure comprising a plurality of independently invertible panels, and wherein increasing the tension on at least one of the plurality of elongate tethers comprises at least partially inverting at least one of the independently invertible panels.

6. The method of claim 5, wherein increasing the tension on at least one of the plurality of elongate tethers comprises fully inverting at least one of the independently invertible panels.

7. The method of claim 5, wherein the plurality of invertible panels are concave in the contracted state and convex in the expanded state, and wherein each of the plurality of invertible panels can be independently contracted and expanded.

8. The method of claim 5, wherein the independently invertible panels comprise nitinol.

9. The method of claim 1, wherein each tether comprises a polymeric material.

10. The method of claim 1, wherein the plurality of tethers are routed over and past both the proximal end and the distal end of the prosthetic heart valve.

11. The method of claim 1, further comprising adjusting the position of the delivery device after decreasing the tension on the plurality of tethers, such that the position of the prosthetic heart valve is again adjusted.

12. The method of claim 1, wherein the prosthetic heart valve is fully contracted by increasing the tension on each of the plurality of tethers of each of a plurality of independently invertible panels.

13. The method of claim 1, wherein decreasing the tension on the plurality of tethers allows the prosthetic heart valve to self-expand.

14. The method of claim 1, further comprising expanding the prosthetic heart valve with an expansion member after decreasing the tension on the plurality of tethers.

15. The method of claim 1, wherein the tension on each of the plurality of tethers is independently adjustable.

16. The method of claim 1, wherein at least one of the plurality of elongate tethers is configured to retain the prosthetic heart valve after expanding the implant.

17. The method of claim 16, wherein decreasing the tension comprises releasing the at least one of the plurality of elongate tethers from the prosthetic heart valve, the method further comprising removing the delivery device while the prosthetic heart valve remains in position within the patient'"'"'s body.

18. A method of using a delivery device for an expandable prosthetic heart valve, comprising:

percutaneously inserting a delivery device into a patient'"'"'s body, wherein the delivery device is coupled with an expandable prosthetic heart valve having a distal end and a proximal end, the delivery device comprising a plurality of elongate tethers positioned to allow manipulation of the expandable prosthetic heart valve, the prosthetic heart valve comprising a support structure coupled with a valvular body, the support structure comprising a plurality of independently invertible panels, wherein increasing the tension on at least one of the plurality of elongate tethers comprises at least partially inverting at least one of the independently invertible panels, wherein the delivery device is percutaneously inserted over a guidewire and one of the plurality of tethers is routed over each of the plurality of independently invertible panels, around the guidewire and back over each of the plurality of independently invertible panels;

expanding the expandable prosthetic heart valve from a contracted state to an expanded state;

increasing a tension on the plurality of tethers from a state where each elongate tether contacts both the distal end and the proximal end of the expandable prosthetic heart valve such that the expandable prosthetic heart valve is at least partially contracted towards a central, longitudinal axis of the delivery device;

adjusting the position of the expandable prosthetic heart valve while at least partially contracted; and

decreasing the tension on the plurality of elongate tethers after adjusting the position of the prosthetic heart valve.