DELIVERY SYSTEM FOR COLLAPSIBLE HEART VALVE

• US 20120078351A1
• Filed: 08/17/2011
• Published: 03/29/2012
• Est. Priority Date: 08/17/2010
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Klima, Daniel J., Wang, Huisun, Thomas, Ralph Joseph, Geiger, Gary W.
• Granted Patent: US 9,700,411 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/00314 Separate linked members
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: Y10T 156/1043 Subsequent to assembly

Abstract

A delivery system for delivering a collapsible prosthetic heart valve includes a valve support structure for supporting a collapsible prosthetic heart valve, and a distal sheath movable in a longitudinal direction relative to the valve support structure between a first position in which the distal sheath is adapted to surround a collapsible prosthetic heart valve supported on the valve support structure, and a second position in which the distal sheath is adapted to expose the collapsible prosthetic heart valve for deployment. The distal sheath is at least partially formed of an inner polymer layer, an outer polymer layer, and a tubular supporting member sandwiched between the inner polymer layer and the outer polymer layer.

Claims

1. A delivery system for delivering a collapsible prosthetic heart valve, comprising:

a valve support structure for supporting a collapsible prosthetic heart valve; and

a distal sheath movable in a longitudinal direction relative to the valve support structure between a first position in which the distal sheath is adapted to surround a collapsible prosthetic heart valve supported on the valve support structure, and a second position in which the distal sheath is adapted to expose the collapsible prosthetic heart valve for deployment, the distal sheath being at least partially formed of an inner polymer layer, an outer polymer layer, and a tubular supporting member sandwiched between the inner polymer layer and the outer polymer layer.

2. The delivery system according to claim 1, wherein the supporting member is made at least in part of a shape memory material.

3. The delivery system according to claim 1, wherein the outer polymer layer includes a polymer selected from the group consisting of nylon, polyether block amide, polyurethane and a combination thereof.

4. The delivery system according to claim 1, wherein the inner polymer layer includes polytetrafluoroethylene.

5. The delivery system according to claim 1, wherein the supporting member includes a plurality of struts coupled to one another by a plurality of connectors so as to define a plurality of open cells.

6. The delivery system according to claim 5, wherein the struts extend in the circumferential direction of the support member and the connectors are arranged in at least one row oriented substantially orthogonally to the struts.

7. The delivery system according to claim 5, wherein the supporting member has a first longitudinal section and a second longitudinal section, the first longitudinal section being more flexible than the second longitudinal section.

8. The delivery system according to claim 7, wherein each strut in the second longitudinal section has a selected width in the longitudinal direction, and each strut in the first longitudinal section has a width in the longitudinal direction which is less than the selected width.

9. The delivery system according to claim 1, wherein the distal sheath has a wall thickness between about 0.005 inches and about 0.015 inches.

10. The delivery system according to claim 1, wherein the inner polymer layer has a higher lubricity than the outer polymer layer.

11. A delivery system for delivering a collapsible prosthetic heart valve, comprising:

a valve support structure for supporting a collapsible prosthetic heart valve; and

a distal sheath preformed with a curved shape, the distal sheath being movable in a longitudinal direction relative to the valve support structure between a first position in which the distal sheath is adapted to surround a prosthetic valve supported on the valve support structure, and a second position in which the distal sheath is adapted to expose the prosthetic valve for deployment.

12. The delivery system according to claim 11, wherein at least a portion of the distal sheath has a radius of curvature between about 2 inches and about 3 inches.

13. The delivery system according to claim 11, wherein the distal sheath includes braided wires.

14. The delivery system according to claim 13, wherein the distal sheath further includes an outer polymer layer surrounding the braided wires.

15. The delivery system according to claim 13, wherein the braided wires are formed of a metal.

16. The delivery system according to claim 13, wherein the distal sheath further includes an inner polymer layer and wherein the braided wires surround at least a portion of the inner polymer layer.

17. A method of manufacturing a delivery system for delivering a collapsible prosthetic heart valve, comprising:

providing a preform including a scaffold structure arranged in a tubular configuration, the preform having a curved profile;

attaching at least one polymer layer to a surface of the preform to produce an assembly;

placing the assembly over a curved mandrel; and

applying heat to the assembly to thermally reform the at least one polymer layer in a curved shape.

18. The method according to claim 17, wherein the scaffold structure includes a plurality of braided wires.

19. The method according to claim 17, wherein the scaffold structure includes a plurality of struts coupled to one another by a plurality of connectors so as to define a plurality of open cells.

20. A method of manufacturing a delivery system for delivering a collapsible prosthetic valve, comprising:

placing a substantially straight distal sheath on a curved mandrel, the distal sheath including a scaffold structure arranged in a tubular configuration and at least one polymer layer attached to a surface of the scaffold structure; and

heating the distal sheath to reform the distal sheath into a curved shape.

21. The method according to claim 20, wherein the heating step includes heating the distal sheath at a temperature between about 200 degrees Fahrenheit and about 300 degrees Fahrenheit.

22. The method according to claim 20, wherein the scaffold structure includes a plurality of braided wires.

23. The method according to claim 22, wherein the heating step includes heating the distal sheath until the braided wires anneal.

24. The method according to claim 20, wherein the scaffold structure includes a plurality of struts coupled to one another by a plurality of connectors so as to define a plurality of open cells.