Aortic Valve Annuloplasty Rings

• US 20070027536A1
• Filed: 06/05/2006
• Published: 02/01/2007
• Est. Priority Date: 12/04/2003
• Status: Abandoned Application

• Current Assignee: Brigham and Women's Hospital Incorporated
• Original Assignee: Brigham and Women's Hospital Incorporated
• Inventors: Mihaljevic, Tomislav, Farivar, R., Cohn, Lawrence
• Application Number:
  US11/422,210
• Publication Number:
  US 20070027536A1
• Time in Patent Office: Days
• US Class Current: 623/2.370
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0004 adjustable

Abstract

An aortic annuloplasty ring may include a ring, having a “C” shape. The ring may be so sized as to fit around and circumferentially engage an aortic root. The ring may be formed at least in part of a biocompatible material so nonresiliently deformable as to permit manual adjustment of the ring. An aortic annuloplasty method may include disposing an aortic annuloplasty ring around an aorta root, the ring having a “C” shape, and the ring being so sized as to fit around and circumferentially engage the aortic root; and deforming the ring to circumferentially engage the aortic root.

Claims

1. An aortic annuloplasty ring, comprising:

a collar having first and second ends that together form a fastener operable to secure the first and second ends together and thereby so shape the collar as to engage the aorta circumferentially; and

a flap depending from the collar for wrapping over the aorta;

the ring being sized to fit around the aorta, and further being transitionable between a first state, in which the fastener does not secure the first and second ends together, and a second state, in which the fastener so secures the first end to the second end that the collar is shaped to engage the aorta circumferentially.

2. The ring of claim 1, wherein the fastener comprises a plurality of catches on the second end selectively receivable by an aperture in the first end, thereby making the ring adjustable.

3. The ring of claim 1, wherein the collar can lie substantially flat in the first state.

4. The ring of claim 1, wherein the collar has a substantially circular shape in the second state.

5. The ring of claim 1 wherein the flap is one of a plurality thereof that depend from the collar.

6. The ring of claim 1, wherein the ring is reversibly transitionable between the first state and the second state.

7. The ring of claim 1, wherein the ring is not reversibly transitionable between the first state and the second state.

8. The ring of claim 1, wherein the fastener is adjustable.

9. The ring of claim 1, further comprising a detent disposed on the collar for engaging the aorta.

10. The ring of claim 1, further comprising a plurality of detents disposed on the collar for engaging the aorta.

11. The ring of claim 1, wherein the collar is formed at least in part from a plastic.

12. The ring of claim 1, wherein the flap is formed at least in part from a plastic.

13. The ring of claim 1, further comprising an adjustment device coupled to the collar.

14. The ring of claim 13, wherein the adjustment device comprises a filament.

15. An adjustable aortic annuloplasty ring, comprising:

a collar having first and second ends that together form a fastener operable to secure the first and second ends together and thereby so shape the collar as to engage the aorta circumferentially, the fastener having a plurality of catches on the second end selectively receivable by an aperture in the first end, thereby making the ring adjustable; and

a plurality of flaps depending from the collar for wrapping over the aorta;

the ring being sized to fit around the aorta, and further being transitionable between a first state, in which the fastener does not secure the first and second ends together, and a second state, in which the fastener so secures the first end to the second end that the collar is shaped substantially circularly to engage the aorta circumferentially.

16. An aortic annuloplasty ring, comprising:

a ring, having a “

C”

shape, and being so sized as to fit around and circumferentially engage an aortic root;

the ring being formed at least in part of a biocompatible material so deformable as to permit manual adjustment of the ring and so nonresilient as to keep the shape into which it is adjusted.

17. The ring of claim 16, wherein the material is gold.

18. The ring of claim 16, wherein the material is 24-karat gold.

19. The ring of claim 16, wherein the material is an alloy.

20. The ring of claim 19, wherein the alloy includes at least 23-karat gold.

21. The ring of claim 19, wherein the alloy includes gold and silver.

22. The ring of claim 21, wherein the alloy includes less than 10% silver.

23. The ring of claim 19, wherein the alloy includes gold and titanium.

24. The ring of claim 19, wherein the alloy includes gold, silver, and titanium.

25. The ring of claim 16, wherein the material is a thermoplastic elastomer.

26. The ring of claim 25, wherein the thermoplastic elastomer is less flexible at body temperature than at room temperature.

27. The ring of claim 25, wherein the material is so deformable as to permit manual adjustment of the ring at temperatures below body temperature.

28. The ring of claim 16, wherein the ring, at body temperature, is so rigid as not to deform.

29. The ring of claim 16, wherein the ring, at body temperature, is so rigid as not to deform in response to arterial blood pressure.

30. The ring of claim 16, wherein the ring, at body temperature, is so rigid as not to deform in response to motion of the aortic root.

31. The ring of claim 16, wherein the material is non-degradable.

32. The ring of claim 16, wherein the “

C”

shape defines a gap, and the gap accounts for at least one fourth of the circumference of the ring.

33. The ring of claim 32, wherein the gap accounts for between one fourth and one third of the circumference of the ring.

34. The ring of claim 16, wherein the “

C”

shape defines a gap, and the gap accounts for at most one third of the circumference of the ring.

35. The ring of claim 16, wherein the ring defines a diameter, the diameter being at least 1 centimeter.

36. The ring of claim 35, wherein the diameter is at most 5 centimeters.

37. The ring of claim 16, wherein the ring defines a diameter, the diameter being at most 5 centimeters.

38. The ring of claim 16, wherein the ring defines a diameter in the range between about 1 centimeter and about 3 centimeters.

39. The ring of claim 16, wherein the ring has rounded contours.

40. The ring of claim 39, wherein the contours of the ring are so rounded as to minimize trauma to a coronary artery.

41. The ring of claim 16, wherein the ring defines a groove so contoured as to receive a coronary artery.

42. The ring of claim 16, wherein the ring circumscribes an arc of a circle.

43. The ring of claim 16, wherein each end of the ring has a projection for engaging a respective arm of an adjustment wrench.

44. The ring of claim 16, wherein each end of the ring defines an indentation for engagement by a respective arm of an adjustment wrench.

45. The ring of claim 16, further comprising a filament coupled to each end of the ring.

46. The ring of claim 16, further comprising an inflatable cuff and a bladder in fluid communication with the cuff.

47. An aortic annuloplasty method, comprising:

disposing an aortic annuloplasty ring around an aorta, the ring including a collar having first and second ends, the first and second ends forming a fastener operable to secure the first and second ends together, the ring further including a flap depending from the collar;

fastening the first and second ends of the collar to each other, thereby so shaping the collar as to engage the aorta circumferentially; and

wrapping the flap over the aorta.

48. The method of claim 47, further comprising unfastening the first and second ends of the collar and refastening the first and second ends in a different position.

49. The method of claim 47, further comprising observing blood flow through the aortic valve and adjusting the ring in response to the blood flow.

50. The method of claim 49, wherein adjusting comprises tightening the ring in response to blood flow indicative of aortic insufficiency.

51. The method of claim 49, wherein adjusting comprises loosening the ring in response to blow flow indicative of aortic stenosis.

52. The method of claim 47, further comprising actuating an adjustment device coupled to the ring.

53. The method of claim 52, wherein the adjustment device comprises a filament, and actuating comprises pulling the filament.

54. The method of claim 52, wherein the adjustment device comprises a wrench having two arms, the arms of the wrench being engaged to the ends of the ring, and actuating comprises clasping the wrench.

55. The method of claim 52, wherein the ring further comprises an inflatable cuff, and the adjustment device comprises a bladder in fluid communication with the cuff, and wherein actuating comprises introducing fluid into or removing fluid from the bladder, thereby changing the inflation of the cuff.

56. The method of claim 47, further comprising measuring the circumference of the aorta and thereby selecting the size of the ring.

57. An aortic annuloplasty method, comprising:

disposing an aortic annuloplasty ring around an aorta root, the ring having a “

C”

shape, the ring being so sized as to fit around and circumferentially engage the aortic root, and the ring being formed at least in part of a biocompatible material so deformable as to permit manual adjustment of the ring and so nonresilient as to keep the shape into which it is deformed; and

deforming the ring to circumferentially engage the aortic root.

58. The method of claim 57, wherein the ring comprises a flap depending from the ring, and the method further comprises wrapping the flap over the aorta.

59. The method of claim 57, further comprising observing blood flow through the aortic valve and adjusting the ring in response to the blood flow.

60. The method of claim 59, wherein adjusting comprises tightening the ring in response to blood flow indicative of aortic insufficiency.

61. The method of claim 59, wherein adjusting comprises loosening the ring in response to blow flow indicative of aortic stenosis.

62. The method of claim 57, further comprising actuating an adjustment device coupled to the ring.

63. The method of claim 62, wherein the adjustment device comprises a filament, and actuating comprises pulling the filament.

64. The method of claim 62, wherein the adjustment device comprises a wrench having two arms, the arms of the wrench being engaged to the ends of the ring, and actuating comprises clasping the wrench.

65. The method of claim 62, wherein the ring further comprises an inflatable cuff, and the adjustment device comprises a bladder in fluid communication with the cuff, and wherein actuating comprises introducing fluid into or removing fluid from the bladder, thereby changing the inflation of the cuff.

66. The method of claim 57, further comprising measuring the circumference of the aorta and thereby selecting the size of the ring.