CUFF CONFIGURATIONS FOR PROSTHETIC HEART VALVE

• US 20140277417A1
• Filed: 03/14/2013
• Published: 09/18/2014
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Schraut, Julia Ann, Braido, Peter Nicholas, Venkatasubramanian, Ramji T., Fahim, Mina Safwat, Kurane, Aditee, Kutty, Jaishankar
• Granted Patent: US 9,326,856 B2
• Time in Patent Office: Days
• US Class Current: 623/2.17
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• 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 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0028 differing in fibre orientations
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic heart valve includes a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end. The stent is formed of a plurality of struts. A cuff is coupled to the stent. The cuff has one or more features configured to reduce abrasion and/or perivalvular leakage.

Claims

1. A prosthetic heart valve, comprising:

a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, the stent including a plurality of struts;

a cuff coupled to a first group of the plurality of struts adjacent a top edge of the cuff and coupled to a second group of the plurality of struts adjacent a bottom edge of the cuff, the top edge being trimmed to closely follow the struts in the first group and the bottom edge being trimmed to closely follow the struts in the second group.

2. The prosthetic heart valve of claim 1, wherein the bottom edge and the top edge of the cuff are disposed less than about 0.5 inches away from a nearest one of the plurality of struts.

3. A prosthetic heart valve, comprising:

a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, the stent including a plurality of struts; and

a collapsible and expandable valve assembly including a cuff and a plurality of leaflets, the plurality of leaflets being coupled to the cuff and the cuff being coupled to selected ones of the plurality of struts via a suture, the cuff being wrapped over one of the plurality of struts to form an outer layer and an inner layer.

4. The prosthetic heart valve of claim 3, wherein the suture includes a first loop that pierces through the outer layer and the inner layer of the cuff and is disposed around a strut to couple the cuff to the strut.

5. The prosthetic heart valve of claim 4, wherein the suture further includes a second loop that couples one of the plurality of leaflets to the outer and inner layer of the cuff.

6. The prosthetic heart valve of claim 3, wherein the suture includes a first loop that pierces through the outer layer of the cuff, the inner layer of the cuff and one of the plurality of leaflets.

7. The prosthetic heart valve of claim 6, wherein the suture further includes a second loop that couples the inner layer of the cuff to one of the plurality of struts.

8. A prosthetic heart valve, comprising:

a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, the stent including a plurality of struts; and

a collapsible and expandable valve assembly including a cuff and a plurality of leaflets, and the cuff being coupled to selected ones of the plurality of struts at suture locations, the cuff having a first thickness in certain regions and a second thickness greater than the first thickness in certain other regions.

9. The prosthetic heart valve of claim 8, wherein the cuff has the second thickness near the suture locations.

10. The prosthetic heart valve of claim 8, wherein the cuff has the second thickness at locations of high stress during operation of the heart valve.

11. The prosthetic heart valve of claim 8, wherein the cuff has the first thickness at locations of low stress during operation of the heart valve.

12. The prosthetic heart valve of claim 8, wherein the stent includes a plurality of commissure features for coupling the plurality of leaflets to the stent, and the cuff has the second thickness near the commissure features.

13. A prosthetic heart valve, comprising:

a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, the stent including a plurality of struts; and

a collapsible and expandable valve assembly including a cuff and a plurality of leaflets, the cuff being coupled to selected ones of the plurality of struts, the cuff having a plurality of fibers oriented in a manner to adequately distribute stress substantially uniformly throughout the cuff.

14. The prosthetic heart valve of claim 13, wherein the cuff includes multiple portions, a first group of the portions having a first fiber orientation and a second group of the portions having a second fiber orientation different from the first fiber orientation.

15. A method of determining the suitability of a cuff, comprising:

applying a predetermined load to the cuff at a location;

measuring an amount of deflection of the cuff at the location in response to the predetermined load; and

determining the suitability of the cuff based on the predetermined load and the amount of deflection.

16. The method of claim 15, wherein the deflection is between about 1.0 mm and about 7.0 mm and the predetermined load is a physiologically relevant and non-destructive load.

17. A prosthetic heart valve, comprising:

a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, the stent including a plurality of struts; and

a collapsible and expandable valve assembly including a cuff and a plurality of leaflets, the cuff being coupled to selected ones of the plurality of struts via a suture, the cuff being formed of a porous material and having microspheres embedded in the porous material, the microspheres being capable of expanding upon contact with blood.

18. The prosthetic heart valve of claim 17, wherein the microspheres comprise dry polyvinyl alcohol sodium acrylate.

19. The prosthetic heart valve of claim 17, further comprising a protective layer disposed over the cuff and configured to prevent expansion of the microspheres prior to implantation of the valve.

20. A prosthetic heart valve, comprising:

a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, the stent including a plurality of struts; and

a collapsible and expandable valve assembly including a cuff and a plurality of leaflets, the cuff being coupled to selected ones of the plurality of struts, the cuff including a first material and a second material, the first material being different from the second material.

21. The prosthetic heart valve of claim 20, wherein the cuff includes a base layer and a plurality of overlying bands.

22. The prosthetic heart valve of claim 21, wherein the base layer is made of a natural tissue and the overlying bands are formed of a synthetic material.

23. The prosthetic heart valve of claim 21, wherein the base layer is made of a synthetic material and the overlying bands are formed of a natural tissue.

24. The prosthetic heart valve of claim 21, wherein the first material is disposed on a luminal side of the stent and the second material is disposed on an abluminal side of the stent.

25. The prosthetic heart valve of claim 21, wherein the first material and the second material are disposed on a luminal side of the stent.

26. A prosthetic heart valve for implanting within a native valve annulus, comprising:

a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, the stent including a plurality of struts;

a collapsible and expandable valve assembly including a cuff and a plurality of leaflets, the cuff being coupled to selected ones of the plurality of struts; and

a buffer including a layer of material coupled to selected regions of the cuff.

27. The prosthetic heart valve of claim 26, wherein the buffer comprises a thin and lubricious material.

28. The prosthetic heart valve of claim 26, wherein the cuff includes a top edge, and the buffer includes a web of material extending around the circumference of the prosthetic heart valve and following the top edge of the cuff.

29. The prosthetic heart valve of claim 26, wherein the buffer includes a plurality of discrete portions.

30. The prosthetic heart valve of claim 29, wherein the stent includes a plurality of commissure features for coupling the plurality of leaflets to the stent and the plurality of discrete portions include a plurality of peaks extending toward the commissure features.

31. The prosthetic heart valve of claim 29, wherein each of the plurality of discrete portions is coupled to the cuff to form a pocket therebetween.

32. The prosthetic heart valve of claim 31, wherein the pockets include a filler material.

33. The prosthetic heart valve of claim 32, wherein the filler material includes PVA sodium acrylate copolymers.

34. A prosthetic heart valve for implanting within a native valve annulus, comprising:

a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, the stent including a plurality of struts; and

a collapsible and expandable valve assembly including a cuff and a plurality of leaflets, the cuff including a first cuff coupled to select ones of the plurality of struts, the first cuff having extended portions configured to wrap around the proximal end of the stent.

35. The prosthetic heart valve of claim 34, wherein the extended portions include portions having a triangular shape.

36. The prosthetic heart valve of claim 34, wherein the extended portions include portions having a substantially diamond shape.

37. The prosthetic heart valve of claim 34, wherein the extended portions include portions having a rectangular shape.

38. The prosthetic heart valve of claim 34, wherein the extended portions include first portions folded to an inner diameter of the stent and second portions folded to an outer diameter of the stent.

39. The prosthetic heart valve of claim 34, further comprising a second cuff coupled to the first cuff, the first cuff having a plurality of pockets.

40. A prosthetic heart valve for implanting within a native valve annulus, comprising:

a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, the stent including a plurality of struts and hinges interposed between selected struts; and

a collapsible and expandable valve assembly including a cuff and a plurality of leaflets, the cuff being coupled to selected ones of the plurality of struts.

41. The prosthetic heart valve of claim 40, wherein the struts define a plurality of cells in the annulus section, the cells being arranged in a plurality of annular rows extending around a circumference of the annulus section, and the hinges are disposed at a midsection of the ells in the annular row of cells closest to the proximal end of the stent.