Implantable prosthetic valve assembly and method for making the same

• US 9,114,008 B2
• Filed: 01/14/2014
• Issued: 08/25/2015
• 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:
  US14/154,495
• Publication Number:
  US 20140128968A1
• Time in Patent Office: 588 Days
• Field of Search: 623 21- 219, 623/1.24, 623/1.26
• US Class Current: 1/1
• 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 frame comprising a first frame portion and a second frame portion connected end-to-end exhibits enhanced rigidity. Each frame portion includes a plurality of circumferential struts formed with multiple bends, with the bends of the first frame portion having angles that are less than the bends of the second frame portion. Some embodiments of the frame have a semi-collapsed state in which the first frame portion is frustoconical and the second frame portion is generally cylindrical. A valve member is attached to the first frame portion.

Claims

1. A percutaneous prosthetic heart valve assembly having enhanced rigidity, 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, 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, the bends of the first frame portion having angles that are less than the angles of the bends of the second frame portion when the frame is in the expanded state; and

a valve member having a base portion attached to the second frame portion and commissure tabs attached to the first and second frame portions;

wherein the frame has a partially collapsed state in which the first frame portion is frusto-conical and the second frame portion is substantially cylindrical, and wherein the frame is substantially cylindrical in the expanded state.

2. The prosthetic heart valve assembly of claim 1, wherein the first frame portion is more rigid than the second frame portion in the expanded state.

3. The prosthetic heart valve assembly of claim 1, wherein each of the circumferential struts comprises a plurality of linear strut members connected to each other at non-zero angles to form the multiple bends of the circumferential strut.

4. The prosthetic heart valve assembly of claim 1, wherein the circumferential struts of the first frame portion comprise first and second arcuate strut members that intersect at junction points to form the multiple bends of the circumferential strut.

5. The prosthetic heart valve assembly of claim 4, wherein the first and second arcuate strut members define ring-shaped cells forming a circumferentially extending band.

6. The prosthetic heart valve assembly of claim 1, wherein the bends of the second frame portion in the expanded state are from about 80°

to about 110°

.

7. The prosthetic heart valve assembly of claim 1, wherein the bends of the first frame portion in the expanded state are from about 90°

to about 130°

.

8. The prosthetic heart valve assembly of claim 1, wherein the bends of the first frame portion in a partially collapsed state are from about 70°

to about 100°

.

9. The prosthetic heart valve assembly of claim 1, wherein the frame comprises a plurality of axial strut members.

10. The prosthetic heart valve assembly of claim 9, wherein the first frame portion comprises axial strut members.

11. The prosthetic heart valve assembly of claim 9, wherein the axial strut members connect the first frame portion and the second frame portion.

12. The prosthetic heart valve assembly of claim 1, wherein the first frame portion comprises a plurality of support posts, each support post comprising a plurality of apertures through which the valve member is sutured.

13. The prosthetic heart valve assembly of claim 1, wherein the valve member defines a tricuspid valve.

14. The prosthetic heart valve assembly of claim 1, further comprising a skirt disposed between the valve member and the frame.

15. The prosthetic heart valve assembly of claim 14, wherein a base portion of the valve member is attached to the skirt.

16. A 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, the frame comprising first and second frame portions connected end-to-end, the first frame portion comprising a circumferentially extending band of ring-shaped cells, each cell comprising a first arcuate strut member and a second arcuate strut member intersecting at an upper and a lower junction point, the second frame portion comprising a plurality of circumferential struts, each strut formed with multiple bends, wherein the frame has a partially collapsed state in which the first frame portion is frusto-conical and the second frame portion is substantially cylindrical, and wherein the frame is substantially cylindrical in the expanded state; and

a valve member connected to the first frame portion, the valve member comprising a tricuspid leaflet valve.

17. The prosthetic heart valve assembly of claim 16, wherein in the expanded state, angles between the first and second arcuate strut members at the upper and lower junction points of the first frame portion are from about 90°

to about 130° and

the bends of the second frame portion are from about 80°

to about 110°

.