Storage assembly for prosthetic valve

• US 10,357,351 B2
• Filed: 11/30/2016
• Issued: 07/23/2019
• Est. Priority Date: 12/04/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Cooper, Alexander H., Bialas, Michael R., Taylor, David M., Tyler, II, Gregory Scott, Kowalski, Zachary R., Kwan, Art Z., Patel, Darshin S., Metchik, Asher L., Popp, Michael J., Anderson, Amanda K.
• Primary Examiner(s): Nguyen, Tuan V
• Application Number:
  US15/364,670
• Publication Number:
  US 20170156839A1
• Time in Patent Office: 965 Days
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 2/9517 handle assemblies therefor

Abstract

In a particular embodiment, the present disclosure provides a prosthetic valve delivery assembly that includes a storage tube. A prosthetic valve having a frame is at least partially disposed within the storage tube. A nose cone is located distally to the valve. A removable tab is disposed between the distal end of the frame and the nose cone. The tab assists in maintaining the position of the nose cone relative to the distal end of the frame.

Claims

1. A prosthetic valve delivery assembly, comprising:

a storage tube;

a prosthetic heart valve comprising a frame, the frame having a distal end and a proximal end, the prosthetic heart valve at least partially disposed within the storage tube;

a nose cone disposed about an elongated shaft, the elongated shaft extending through the storage tube, the nose cone having a distal end and a proximal end; and

a removable tab disposed between the distal end of the frame and the nose cone;

wherein the tab assists in maintaining the position of the nose cone relative to the distal end of the frame.

2. The assembly of claim 1, wherein the nose cone comprises a distal conical portion extending from a distal apex to a base and an intermediate portion extending proximally from the base, the diameter of the intermediate portion proximate the base being smaller than a diameter of the base of the distal portion, wherein the tab is configured to be disposed about the intermediate nose cone portion proximate the base of the distal nose cone portion.

3. The assembly of claim 2, wherein the tab defines a pair of arms disposed about the intermediate nose cone portion.

4. The assembly of claim 3, wherein the arms comprise inner arms and the tab further defines a pair of outer arms, the outer arms extending about the inner arms.

5. The assembly of claim 4, wherein the outer arms engage an outer surface of the storage tube.

6. The assembly of claim 4, further comprising a nose cone cap extending over the distal end of the nose cone, wherein the outer arms of the tab engage an outer surface of the nose cone cap.

7. The assembly of claim 3, wherein an outer surface of the storage tube defines a radially extending slot configured to receive the arms of the tab.

8. The assembly of claim 1, wherein the tab comprises a gripping surface.

9. The assembly of claim 1, further comprising a nose cone cap extending over at least a distal portion of the nose cone and releasably coupled to a distal end of the storage tube.

10. The assembly of claim 9, wherein the nose cone cap has an inner surface defining a plurality of axially and radially extending fins, the fins defining a cavity for receiving at least the distal end portion of the nose cone.

11. The assembly of claim 9, further comprising a stylet having an elongated shaft and a loop at the distal end of the elongated shaft, wherein the loop is disposed within the nose cone cap.

12. The assembly of claim 1, wherein the tab defines a pair of arms, the assembly further comprising a nose cone cap extending over at least a distal end portion of the nose cone, the nose cone cap having a distal end and a proximal end, the proximal end of the cap defining a proximally extending tab arm configured to be received between the arms of the tab.

13. The assembly of claim 1, wherein the valve extends distally beyond a distal end of the storage tube, and a proximal face of the tab abuts the valve.

14. A method for securing the position of a nose cone relative to a prosthetic valve, comprising:

placing the prosthetic valve at least partially within a storage tube;

positioning a nose cone relative to the valve; and

inserting a tab about the nose cone and the valve such that the nose cone is restrained from proximal movement relative to the tab.

15. The method of claim 14, further comprising placing a nose cone cap over a distal end portion of the nose cone and securing the nose cone cap to the storage tube, wherein the nose cone is restrained from moving distally relative to the storage tube by the nose cone cap.

16. The method of claim 15, wherein the nose cone cap comprises a plurality of internal fins, and the nose cone is received in a cavity formed by the fins.

17. The method of claim 15, further comprising securing arms of the tab about an exterior surface of the nose cone cap.

18. The method of claim 14, wherein inserting a tab about the nose cone and the valve comprising inserting the tab through a slot formed in an outer surface of the storage tube.

19. The method of claim 14, wherein a frame of the prosthetic valve extends beyond a distal end of the storage tube.

20. The method of claim 14, further comprising inserting a stylet proximally through a distal end of the nose cone.