Prosthetic heart valve delivery apparatus

Patent metadata

Field	Value
Publication number	US-12186183-B2
Application number	US-202117485154-A
Country	US
Kind code	B2
Filing date	Sep 24, 2021
Priority date	Feb 25, 2011
Publication date	Jan 7, 2025
Grant date	Jan 7, 2025

Abstract

Certain embodiments of the present disclosure provide a prosthetic valve (e.g., prosthetic heart valve) and a valve delivery apparatus for delivery of the prosthetic valve to a native valve site via the human vasculature. The delivery apparatus is particularly suited for advancing a prosthetic heart valve through the aorta (i.e., in a retrograde approach) for replacing a diseased native aortic valve. The delivery apparatus in particular embodiments is configured to deploy a prosthetic valve from a delivery sheath in a precise and controlled manner at the target location within the body.

First claim

The invention claimed is:

1. A method comprising:
positioning a catheter portion of a delivery device within a patient's vasculature, the catheter portion comprising a sheath and an inner shaft, with at least a portion of the inner shaft positioned within the sheath, wherein the inner shaft supports a radially collapsed prosthetic heart valve mounted thereon and the inner shaft has a nose cone attached to a distal end thereof, and wherein the sheath is covering the radially collapsed prosthetic heart valve;
positioning a handle of the delivery device outside the patient with the handle coupled to the catheter portion, wherein the handle comprises a sheath actuator that is operatively coupled to the sheath, and wherein the inner shaft extends through the handle and is fixedly coupled to a shaft retractor;
with the shaft retractor in a locked positioned relative to the handle, operating the sheath actuator to retract the sheath proximally relative to the inner shaft to uncover the prosthetic heart valve and allow the prosthetic heart valve to radially expand within the patient;
pressing a portion of the shaft retractor radially inwardly to unlock the shaft retractor from the handle; and
with the prosthetic heart valve radially expanded and the shaft retractor unlocked from the handle, moving the shaft retractor proximally relative to the handle to pull the inner shaft and nosecone proximally relative to the sheath.

2. The method of claim 1 , wherein pressing the portion of the shaft retractor radially inwardly comprises forcing the portion of the shaft retractor from an outwardly biased position toward an inward position.

3. The method of claim 1 , wherein pressing the portion of the shaft retractor radially inwardly comprises pressing two opposing parts radially inwardly toward each other to unlock the shaft retractor from the handle.

4. The method of claim 1 , further comprising, after pressing the portion of the shaft retractor radially inwardly to unlock the shaft retractor from the handle and moving the shaft retractor proximally relative to the handle, releasing the portion of the shaft retractor and allowing the portion of the shaft retractor to return to a radially outwardly biased position.

5. The method of claim 1 , wherein moving the shaft retractor proximally relative to the handle retracts the nosecone proximally through the expanded prosthetic heart valve.

6. The method of claim 1 , wherein moving the shaft retractor proximally relative to the handle translates the inner shaft proximally through the handle.

7. The method of claim 1 , wherein when the sheath retractor retracts the sheath proximally, a distal end of the sheath radially expands to accommodate partial radial expansion of a distal portion of the prosthetic heart valve.

8. The method of claim 7 , further comprising operating the sheath retractor to move the sheath distally back over the distal portion of the prosthetic heart valve to recompress the prosthetic heart valve to a fully radially compressed state.

9. The method of claim 1 , wherein pulling the inner shaft and nosecone proximally relative to the sheath comprises causing the nosecone to abut a distal end of the sheath.

10. The method of claim 9 , further comprising, with the prosthetic heart valve radially expanded and the nosecone abutting the distal end of the sheath, pulling the handle proximally to retract the catheter portion from the patient's vasculature.

11. A method comprising:
positioning a catheter portion of a delivery device within a patient's vasculature, the catheter portion comprising a sheath and an inner shaft, with at least a portion of the inner shaft positioned within the sheath, wherein the inner shaft supports a radially collapsed prosthetic heart valve mounted thereon and the inner shaft has a nose cone attached to a distal end thereof, and wherein the sheath is covering the radially collapsed prosthetic heart valve;
positioning a handle of the delivery device outside the patient with the handle coupled to the catheter portion, wherein the handle comprises a sheath actuator that is operatively coupled to the sheath, and wherein the inner shaft extends through the handle and is fixedly coupled to a shaft retractor, the shaft retractor being in a locked position relative to the handle;
pressing two opposing parts of the shaft retractor radially inwardly toward one another to unlock the shaft retractor from the handle, wherein pressing the two opposing parts radially inwardly comprises forcing the two opposing parts from outwardly biased positions toward inward positions; and
with the shaft retractor unlocked from the handle, moving the shaft retractor proximally relative to the handle to pull the inner shaft and nosecone proximally relative to the sheath.

12. The method of claim 11 , further comprising, after pressing the p two opposing parts of the shaft retractor radially inwardly to unlock the shaft retractor from the handle and moving the shaft retractor proximally relative to the handle, releasing the two opposing parts of the shaft retractor and allowing the two opposing parts of the shaft retractor to return to their outwardly biased positions.

13. The method of claim 11 , wherein moving the shaft retractor proximally relative to the handle translates the inner shaft proximally through the handle.

14. The method of claim 11 , further comprising, with the shaft retractor in the locked positioned relative to the handle, operating the sheath actuator to retract the sheath proximally relative to the inner shaft to uncover the prosthetic heart valve and allow the prosthetic heart valve to radially expand within the patient.

15. The method of claim 14 , wherein moving the shaft retractor proximally relative to the handle retracts the nosecone proximally through the expanded prosthetic heart valve.

16. The method of claim 14 , wherein when the sheath retractor retracts the sheath proximally, a distal end of the sheath radially expands to accommodate partial radial expansion of a distal portion of the prosthetic heart valve.

17. The method of claim 16 , further comprising operating the sheath retractor to move the sheath distally back over the distal portion of the prosthetic heart valve to recompress the prosthetic heart valve to a fully radially compressed state.

18. The method of claim 14 , wherein pulling the inner shaft and nosecone proximally relative to the sheath comprises causing the nosecone to abut a distal end of the sheath.

19. The method of claim 18 , further comprising, with the prosthetic heart valve radially expanded and the nosecone abutting the distal end of the sheath, pulling the handle proximally to retract the catheter portion from the patient's vasculature.

20. A method comprising:
pressing two opposing parts of a shaft retractor toward one another to unlock the shaft retractor from a handle, wherein pressing the two opposing parts toward each other comprises forcing the two opposing parts from farther-apart positions toward closer-together positions, the two opposing parts being biased toward the farther-apart positions; and
with the shaft retractor unlocked from the handle, moving the shaft retractor away from the handle to pull an inner shaft through handle, the inner shaft being fixedly coupled to the shaft retractor;
wherein the shaft retractor, the handle, and the inner shaft are configured to be implemented in a transcatheter system for delivering a prosthetic device into a patient's body.

Assignees

• Edwards Lifesciences Corp

Inventors

• Popp Michael J
• Alon David
• Liu Jun
• Pesce Luca
• Jafari Mohammad

Classifications

• A61F2250/0036

  differing in thickness · CPC title

• A61F2210/0014

  using shape memory or superelastic materials, e.g. nitinol · CPC title

• A61F2250/0039

  differing in diameter · CPC title

• A61F2/2415

  Manufacturing methods · CPC title

• A61F2/2412

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title