EXPANDABLE STENT VALVE

• US 20170014228A1
• Filed: 11/26/2014
• Published: 01/19/2017
• Est. Priority Date: 11/26/2013
• Status: Active Grant

• Current Assignee: Children's Medical Center Corporation
• Original Assignee: Children's Medical Center Corporation
• Inventors: Emani, Sitaram, Marshall, Audrey C., Lock, James E., del Nido, Pedro J.
• Granted Patent: US 10,478,290 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• 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 2230/0067 conical
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

An expandable valve (100) and valve frame device that may be implanted within the body, for example, at a position of the heart. The device may be surgically implanted and subsequently expanded at a later time. The device may include an expandable sewing member (160) surrounding the valve frame (130) at a region between upstream and downstream ends of the device, for attaching the device to surrounding tissue. The device may include a membrane (140) for blocking leakage out the side of the valve frame between opposite ends. However, the membrane may include a side opening (170) for guiding fluid flow toward an appropriate anatomical outflow tract. The device may include a hood-like covering attached to a tissue wall, for smoothly receiving and guiding fluid flow along a perpendicular bend. The device may further include a flared opening at a downstream end, providing adequate space for device attachment.

Claims

1. A device for implantation at a position of a heart, the device comprising:

a valve frame defining a lumen, the valve frame having an upstream end and a downstream end;

a plurality of valve leaflets attached to and disposed within the valve frame; and

a sewing member surrounding the valve frame at a region between the upstream end and the downstream end, for forming an attachment to tissue at the position of the heart.

2. The device of claim 1, wherein the valve frame is expandable.

3. The device of claim 1, wherein the valve frame is expandable from a first diameter between 9 mm and 18 mm to a second diameter between 10 mm and 22 mm.

4. The device of claim 1, wherein the valve frame is expandable from a first diameter between 11 mm and 13 mm to a second diameter between 13 mm and 15 mm.

5. The device of claim 1, wherein the valve is expandable.

6. The device of claim 1, wherein the sewing member is expandable.

7. The device of claim 1, wherein the sewing member is attached to the valve frame.

8. The device of claim 1, wherein an edge of at least one of the upstream end and the downstream end of the valve frame has a substantially level surface.

9. The device of claim 1, further comprising a membrane disposed about the valve frame for obstructing fluid flow between the lumen and an external region surrounding the valve frame.

10. The device of claim 9, wherein a portion of the membrane at a side region and proximate the downstream end of the valve frame comprises an opening that permits fluid flow there through.

11. The device of claim 10, wherein the opening comprises a cut out of the membrane extending along a plane that is parallel to or forms an angle with respect to a longitudinal axis of the valve frame

12. The device of claim 11, wherein a downstream end of the membrane comprises a cut out extending along a plane that is substantially perpendicular to the longitudinal axis of the valve frame.

13. The device of claim 1, further comprising an attachment region proximate to the downstream end of the valve frame, for forming an attachment to tissue at a wall of the heart.

14. The device of claim 1, wherein the valve frame has a length of between 1.0 cm and 2.5 cm.

15. The device of claim 1, wherein the sewing member is located substantially concentric with the plurality of valve leaflets.

16. The device of claim 1, wherein the position comprises a mitral valve position of the heart.

17. The device of claim 1, wherein the position comprises a transmural position of the heart.

18. The device of claim 1, wherein the sewing member surrounds the valve frame at approximately a midpoint between the upstream end and the downstream end.

19. The device of claim 1, wherein the sewing member comprises a corrugated cuff.

20. A device for implantation at a position of a heart, the device comprising:

a valve frame defining a lumen, the valve frame having an upstream end and a downstream end;

a membrane disposed about the valve frame for obstructing fluid flow between the lumen and an external region surrounding the valve frame, wherein a portion of the membrane at a side region and proximate the downstream end of the valve frame comprises an opening that permits fluid flow there through; and

a plurality of valve leaflets attached to and disposed within the valve frame.

21. The device of claim 20, wherein the opening comprises a cut out of the membrane extending along a plane that is parallel to or forms an angle with respect to a longitudinal axis of the valve frame

22. The device of claim 21, wherein the angle is between 0 degrees and 90 degrees with respect to the longitudinal axis of the valve frame.

23. The device of claim 20, wherein the opening is adapted to provide for passage of fluid toward a ventricular outflow tract or a coronary vessel.

24. The device of claim 20, further comprising a sewing member surrounding the valve frame at a region between the upstream end and the downstream end, for forming an attachment to tissue at the position of the heart.

25. The device of claim 20, further comprising an attachment region proximate the downstream end of the valve frame, for forming an attachment to tissue at a wall of the heart.

26. A method of implanting a device at a position of the heart, the device including a valve frame defining a lumen, the valve frame having an upstream end and a downstream end, and a plurality of valve leaflets attached to and disposed within the valve frame, the method comprising:

positioning the valve frame at the position of the heart; and

attaching a sewing member surrounding the valve frame at a region between the upstream end and the downstream end to tissue at the position of the heart.

27. The method of claim 26, wherein positioning the valve frame at the position of the heart comprises surgically implanting the valve frame at the position of the heart.

28. The method of claim 26, further comprising expanding the valve frame from a first diameter to a second diameter.

29. The method of claim 28, wherein the first diameter is between 9 mm and 18 mm and the second diameter is between 10 mm and 22 mm.

30. The method of claim 28, wherein expanding the valve frame comprises inflating a transcatheter balloon within the lumen of the valve frame.

31. The method of claim 28, wherein expanding the valve frame comprises expanding the sewing member and the plurality of valve leaflets.

32. The method of claim 26, further comprising attaching the valve frame to tissue at a wall of the heart at an attachment region of the valve frame proximate the downstream end.

33. The method of claim 26, further comprising trimming the valve frame to a length of between 1.5 cm and 2.0 cm.

34. The method of claim 26, wherein the wall of the heart comprises the left ventricular wall of the heart.

35. The method of claim 26, wherein the sewing member is located substantially concentric with the plurality of valve leaflets.

36. The method of claim 26, wherein the position comprises a mitral valve position of the heart.

37. The method of claim 26, wherein the position comprises a transmural position of the heart.

38. A device for implantation at a position of a heart, the device comprising:

a valve frame defining a lumen, the valve frame having an upstream end and a downstream end;

a plurality of valve leaflets attached to and disposed within the valve frame; and

a covering comprising a membrane attached to the valve frame at the upstream end, the covering having an opening that faces in a direction for guiding fluid, flowing near the upstream end substantially perpendicular to a longitudinal axis of the valve frame, into the lumen of the valve frame.

39. The device of claim 38, wherein the covering comprises an attachment region, for forming an attachment to tissue at a wall of the heart.

40. The device of claim 38, wherein the opening of the covering faces in a direction that is substantially perpendicular to the longitudinal axis of the valve frame at the upstream end.

41. The device of claim 38, further comprising a membrane disposed about the valve frame for obstructing fluid flow between the lumen and an external region surrounding the valve frame.

42. The device of claim 38, wherein the downstream end of the valve frame is associated with a flared opening, for accommodating attachment to tissue at an outflow tract of the heart.

43. The device of claim 38, wherein the valve frame and the plurality of valve leaflets are expandable.

44. A device for implantation at a position of a heart, the device comprising:

a valve frame defining a lumen, the valve frame having an upstream end and a downstream end, the downstream end associated with a flared opening, for accommodating attachment to tissue at a vessel of the heart; and

a plurality of valve leaflets attached to and disposed within the valve frame.

45. The device of claim 44, wherein the downstream end of the valve frame comprises a sewing member having the flared opening.

46. The device of claim 44, wherein the downstream end comprises the flared opening.

47. The device of claim 44, further comprising a covering including a membrane attached to the valve frame at the upstream end, the covering having an opening that faces in a direction for guiding fluid, flowing near the upstream end substantially perpendicular to a longitudinal axis of the valve frame, into the lumen of the valve frame.

48. The device of claim 44, wherein the valve frame and the plurality of valve leaflets are expandable.

49. A method of implanting a device at a position of the heart, the device including a valve frame defining a lumen, the valve frame having an upstream end and a downstream end, and a plurality of valve leaflets attached to and disposed within the valve frame, the method comprising:

positioning the valve frame at the position of the heart;

attaching the valve frame, at the downstream end, to tissue at a vessel of the heart; and

attaching a covering comprising a membrane, attached to the valve frame at the upstream end, to tissue at a wall of the heart, the covering having an opening that faces in a direction for guiding fluid, flowing near the upstream end substantially perpendicular to a longitudinal axis of the valve frame, into the lumen of the valve frame.

50. The method of claim 49, wherein positioning the valve frame at the position of the heart comprises surgically implanting the valve frame at the position of the heart.

51. The method of claim 49, further comprising expanding the valve frame from a first diameter to a second diameter.

52. The method of claim 51, wherein expanding the valve frame comprises inflating a transcatheter balloon within the lumen of the valve frame.

53. The method of claim 49, wherein the vessel of the heart comprises the right ventricular outflow tract of the heart.

54. The method of claim 49, wherein the wall of the heart comprises the right ventricular wall of the heart.

55. The method of claim 49, wherein the position comprises a pulmonary valve position of the heart.

56. The method of claim 49, wherein the position comprises a transmural position of the heart.