Implantable prosthetic valve assembly and method for making the same

• US 8,628,569 B2
• Filed: 08/07/2012
• Issued: 01/14/2014
• Est. Priority Date: 12/22/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Benichou, Netanel, Spenser, Benjamin, Bash, Assaf
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US13/569,028
• Publication Number:
  US 20120303113A1
• Time in Patent Office: 525 Days
• Field of Search: 623 21- 219
• US Class Current: 623/2.1
• 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 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

Abstract

An implantable prosthetic valve assembly having a support stent, or frame, having circumferential struts with multiple bends forming obtuse angles when the valve assembly is expanded to its functional size. The frame can be manufactured with one or more of the circumferential struts in a partially collapsed state and a flexible valve member can be mounted to the partially collapsed frame. The partially collapsed struts can be formed with multiple bends having angles selected to facilitate crimping of the frame to a profile suitable for percutaneous delivery. When the frame is expanded, the bends can expand to form obtuse angles, thereby enhancing the rigidity of the frame to better resist closing forces exerted on the valve assembly.

Claims

1. A percutaneous prosthetic heart valve assembly having enhanced rigidity, comprising:

a radially compressible and expandable support stent, the support stent having a compressed state with a compressed diameter for percutaneous delivery of the prosthetic heart valve assembly to an implantation site, the support stent having an expanded state with an expanded diameter for operation of the prosthetic heart valve assembly at the implantation site, the support stent further having a partially collapsed state with a partially collapsed diameter that is between the compressed and expanded diameters for attachment of a valve member and storage of the assembly, the support stent formed with a plurality of circumferential bands, each band comprising a plurality of linear strut members forming a zig-zag configuration, wherein when the support stent is in the partially collapsed state adjacent strut members form angles of between about 50-90°

, and in the expanded state adjacent strut members form angles of about 90-179°

for enhanced rigidity when the support stent is in the expanded state; and

a flexible valve member coupled to the support stent in the partially collapsed state, wherein the valve member has an expanded configuration suitable for functioning as a one-way valve with a corresponding diameter that matches the expanded diameter of the support stent, and attaches at spaced locations within the support stent when the support stent is in the partially collapsed state with locations therebetween that are out of contact with the stent.

2. The prosthetic heart valve assembly of claim 1, further comprising a flexible skirt positioned between the support stent and the flexible valve member, wherein the skirt is sutured to the support stent and the valve member is sutured to the skirt.

3. A method for deploying the valve assembly of claim 1 at a native valve site of a patient, the method comprising:

mounting the prosthetic heart valve assembly in the compressed state on a flexible catheter;

guiding the catheter through the patient'"'"'s vasculature to the native valve site; and

expanding the prosthetic heart valve assembly to cause the support stent to become anchored to the native valve site.

4. The prosthetic heart valve assembly of claim 2, wherein in the partially compressed state of the support stent, the flexible skirt includes multiple angularly-spaced, radially extending folds having outer apices that are attached to the support stent.

5. The prosthetic heart valve assembly of claim 2, wherein the flexible skirt has visual indicia marking spaced attachment locations along the length of the skirt to indicate locations for attaching the skirt to the inner surface of the support stent.

6. The prosthetic heart valve assembly of claim 5, wherein the visual indicia are selected from the group consisting of:

markings, slits or apertures, sutures attached to the skirt, and a longitudinal edge of the skirt shaped to indicate the attachment locations.

7. The prosthetic heart valve assembly of claim 5, wherein the flexible skirt is formed with a generally saw-tooth shaped circumferential edge to indicate the attachment locations.

8. The prosthetic heart valve assembly of claim 1, wherein the partially collapsed diameter is approximately mid-way between the compressed and expanded diameters.

9. The prosthetic heart valve assembly of claim 8, wherein the partially collapsed diameter is about two times the compressed diameter, and the expanded diameter is about 1.5 times the partially collapsed diameter.

10. The prosthetic heart valve assembly of claim 9, wherein the expanded diameter is about 23 mm, the partially collapsed diameter is about 15 mm, and the compressed diameter is about 7 mm.

11. The prosthetic heart valve assembly of claim 1, wherein when the support stent is in the partially collapsed state the flexible valve member is folded within the support stent so as to have an undulating shape with outer fold apexes that contact and attach to the support stent.

12. The prosthetic heart valve assembly of claim 11, wherein the valve member has slack portions between outer fold apexes that remain out of contact with the support stent, and wherein when the support stent is expanded to the expanded state, the valve member assumes a tubular cross-sectional profile within the support stent.

13. The prosthetic heart valve assembly of claim 1, wherein the support stent is balloon-expandable.

14. The prosthetic heart valve assembly of claim 1, wherein the support stent is self-expandable.

15. The prosthetic heart valve assembly of claim 1, wherein the support stent further comprises a plurality of support beams spaced at about 120-degree intervals from each other around the support stent and connected to each of the circumferential bands, the support beams being formed with apertures to mount the flexible valve member by suturing to the beams.

16. The prosthetic heart valve assembly of claim 1, wherein the support stent comprises a first frame portion connected end-to-end to a second frame portion, and the flexible valve member is connected to the second frame portion, wherein the first frame portion has a more rigid construction than the second frame portion.

17. The prosthetic heart valve assembly of claim 1, wherein when the support stent is in the partially collapsed state, adjacent strut members form angles that render the circumferential bands nearly circular.

18. A percutaneous prosthetic heart valve assembly comprising:

a frame that is radially compressible to a compressed state for percutaneous delivery of the valve assembly and radially expandable to an expanded state for operation of the valve assembly at the implantation site, the frame comprising first and second frame portions connected end-to-end, each frame portion comprising a plurality of circumferential struts, each strut formed with multiple bends, and

a flexible valve member connected to the second frame portion,

and wherein the frame has a partially collapsed state with the first frame portion having a partially collapsed diameter that is between the diameters of the first frame portion in its compressed and expanded states and where the second frame portion is in its expanded state having an inner diameter approximately equal to an outer diameter of the valve member, and in the partially collapsed state of the frame the bends of the first frame portion having angles θ

₁ that are less than angles θ

₂ of the bends of the second frame portion.

19. The prosthetic heart valve assembly of claim 18, wherein in the partially collapsed state of the frame the first frame portion has a frusto-conical shape tapering from a first diameter at an end connected to the second frame portion to a second, smaller diameter at the opposite end.

20. The prosthetic heart valve assembly of claim 18, wherein in the partially collapsed state the second, smaller diameter of the first frame portion is approximately mid-way between the compressed and expanded diameters of the frame.

21. The prosthetic heart valve assembly of claim 18, wherein the first frame portion has a more rigid construction than the second frame portion.

22. The prosthetic heart valve assembly of claim 18, wherein 90 degrees <

θ

₁ <

179 degrees.

23. The prosthetic heart valve assembly of claim 18, further comprising a flexible skirt positioned between the second frame portion and the flexible valve member, wherein the skirt is sutured to the second frame portion and the valve member is sutured to the skirt.

24. The prosthetic heart valve assembly of claim 18, wherein the frame is balloon-expandable.

25. The prosthetic heart valve assembly of claim 18, wherein the frame is self-expandable.

26. The prosthetic heart valve assembly of claim 18, wherein the second frame portion further comprises a plurality of support beams spaced at about 120-degree intervals from each other around the second frame portion and connected to each of the circumferential struts, the support beams being formed with apertures to mount the flexible valve member by suturing to the beams.