Focused compression mitral valve device and method

• US 6,949,122 B2
• Filed: 11/01/2001
• Issued: 09/27/2005
• Est. Priority Date: 11/01/2001
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Mathis, Mark L., Adams, John M., Reuter, David G., Wolf, Scott J.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US10/003,910
• Publication Number:
  US 20030083538A1
• Time in Patent Office: 1,426 Days
• Field of Search: 600 16- 18, 623/1.15, 623/1.11, 623/1.16, 623/1.18, 623/1.22, 623 21- 242
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes

Abstract

A mitral valve therapy device and method treats dilated cardiomyopathy. The device is configured to be placed in the coronary sinus of a heart adjacent to the mitral valve annulus. The device includes a force distributor that distributes an applied force along a pericardial wall of the coronary sinus, and a force applier that applies the applied force to one or more discrete portions of a wall of the coronary sinus adjacent to the mitral valve annulus to reshape the mitral valve annulus in a localized manner.

Claims

1. A mitral valve therapy device configured to be placed in the coronary sinus of a heart adjacent to the mitral valve annulus, the device comprising a force applier that applies an applied force to a discrete portion of the atrial wall of the coronary sinus adjacent to the mitral valve annulus to concentrate the applied force on a discrete portion of the mitral valve annulus.

2. The device of claim 1 wherein the coronary sinus has an unstressed cross-sectional dimension and wherein the force applier has a cross-sectional dimension greater than the unstressed cross-sectional dimension of the coronary sinus to change the shape of the mitral valve annulus.

3. The device of claim 1 wherein the force applier applies the applied force to a plurality of discrete portions of the atrial wall of the coronary sinus.

4. A mitral valve therapy device configured to be placed in the coronary sinus of a heart adjacent to the mitral valve annulus, the device comprising a force applier that applies an applied force to a discrete portion of the atrial wall of the coronary sinus adjacent to the mitral valve annulus to concentrate the applied force on a discrete portion of the mitral valve annulus,

wherein the mitral valve annulus has a circumference, wherein the coronary sinus has a cross sectional diameter, and wherein the force applier has an axial length substantially less than half the circumference of the mitral valve annulus and a deployed transverse dimension greater than the diameter of the coronary sinus.

5. The device of claim 4 wherein the device comprises an expandable structure that expands from a collapsed condition to an expanded condition defining the deployed transverse dimension.

6. The device of claim 5 wherein the expandable structure is self-expandable.

7. The device of claim 5 wherein the expandable structure is mechanically expandable.

8. The device of claim 7 wherein the expandable structure is pull wire expandable.

9. The device of claim 5 wherein the device is cylindrical in configuration.

10. The device of claim 9 wherein the device is a frame structure.

11. The device of claim 10 wherein the frame structure is balloon expandable.

12. A mitral valve therapy device configured to be placed in the coronary sinus of a heart adjacent to the mitral valve annulus, the device comprising a force applier that applies an applied force to a discrete portion of the atrial wall of the coronary sinus adjacent to the mitral valve annulus to concentrate the applied force on a discrete portion of the mitral valve annulus,

the device further including a force distributor that distributes the applied force along a pericardial wall of the coronary sinus.

13. The device of claim 12 wherein the force applier applies the applied force to a plurality of discrete portions of the atrial wall of the coronary sinus.

14. The device of claim 12 wherein the force distributor has a surface area, wherein the force applier has a surface area defining the discrete portion, and wherein the surface area of the force distributor is greater than the surface area of the force applier.

15. A mitral valve therapy device configured to be placed in the coronary sinus of a heart adjacent to the mitral valve annulus, the device comprising a force applier that applies an applied force to a discrete portion of the atrial wall of the coronary sinus adjacent to the mitral valve annulus to concentrate the applied force on a discrete portion of the mitral valve annulus, wherein the force applier is a balloon.

16. A mitral valve therapy device configured to be placed in the coronary sinus of a heart adjacent to the mitral valve annulus, the device comprising:

a force distributor that distributes an applied force along a pericardial wall of the coronary sinus;

a force applier that applies the applied force to at least one discrete portion of a wall of the coronary sinus adjacent to the mitral valve annulus to concentrate the applied force on at least one discrete portion of the mitral valve annulus.

17. The device of claim 16 wherein the mitral valve annulus has a circumference and wherein the force applier has a length substantially less than one half the mitral valve annulus circumference.

18. The device of claim 16 wherein the force applier applies the applied force to a plurality of discrete portions of the wall of the coronary sinus adjacent to the mitral valve annulus.

19. The device of claim 16 wherein the force distributor comprises an elongated first member configured to substantially continuously contact the pericardial wall of the coronary sinus and wherein the force applier comprises a second member extending from the first member at an angle, the second member having an end that applies the applied force.

20. The device of claim 19 wherein the second member is resiliently connected to the first member.

21. The device of claim 19 wherein the first and second members are integrally formed from a same elongated member.

22. The device of claim 21 wherein the same elongated member is formed from a resilient material.

23. The device of claim 19 wherein the first member has opposed ends and wherein the second member extends from the first member intermediate the opposed ends of the first member.

24. The device of claim 23 wherein the force applier further includes at least one additional member extending from the first member intermediate the opposed ends of the first member.

25. The device of claim 24 wherein the at least one additional member extends from the first member substantially parallel to the second member.

26. The device of claim 24 wherein the first and second members form an integral structure.

27. The device of claim 24 wherein the plurality of columnar frame structures are expandable from a collapsed condition to an expanded columnar condition.

28. The device of claim 27 wherein the plurality of columnar frame structures are self-expandable.

29. The device of claim 27 wherein the plurality of columnar frame structures are balloon expandable.

30. The device of claim 16 wherein the force distributor is an elongated frame structure and wherein the force applier comprises at least one columnar frame structure extending from the elongated frame structure.

31. The device of claim 30 wherein the at least one columnar frame structure is expandable from a collapsed condition to an expanded columnar condition.

32. The device of claim 31 wherein the at least one columnar frame structure is self-expandable.

33. The device of claim 31 wherein the at least one columnar frame structure is balloon expandable.

34. The device of claim 30 wherein the elongated frame structure is expandable from a collapsed condition to an expanded condition.

35. The device of claim 34 wherein the elongated frame structure is self-expandable.

36. The device of claim 34 wherein the elongated frame structure is balloon expandable.

37. The device of claim 30 wherein the force applier comprises a plurality of columnar frame structures.

38. The device of claim 16 wherein the device is an elongated frame structure, the elongated frame structure having a portion of increased transverse dimension to form the force applier.

39. The device of claim 38 wherein the elongated frame structure is expandable in transverse dimension.

40. The device of claim 39 wherein the elongated frame structure is self-expandable.

41. The device of claim 39 wherein the elongated frame structure is balloon expandable.

42. The device of claim 16 wherein the device is an elongated member having outwardly curved end portions that engage the pericardial wall of the coronary sinus to form the force distributor and an inwardly curved portion between the outwardly curved end portions to form the force applier.

43. A method of treating dilated cardiomyopathy of a heart including the step of applying a force to a discrete localized portion of an atrial wall of a coronary sinus to concentrate the force on a corresponding localized portion of a mitral valve annulus to change the shape of the mitral valve annulus.

45. The method of claim 43 wherein the applying step includes the step of implanting a force applying device in the coronary sinus, the device applying the force to the discrete localized portion of the coronary sinus.

44. A method of treating dilated cardiomyopathy of a heart including the step of applying a force to a discrete localized portion of an atrial wall of a coronary sinus to concentrate the force on a corresponding localized portion of a mitral valve annulus to change the shape of the mitral valve annulus, wherein the applying step includes inflating a balloon within the coronary sinus.

46. A method of treating dilated cardiomyopathy of a heart including the step of applying a force to a discrete localized portion of an atrial wall of a coronary sinus to concentrate the force on a corresponding localized portion of a mitral valve annulus to change the shape of the mitral valve annulus, wherein the applying step includes the step of implanting a force applying device in the coronary sinus, the device applying the force to the discrete localized portion of the coronary sinus, wherein the device is expandable from a collapsed condition to a deployed condition, wherein the implanting step is carried out while the device is in the collapsed condition, and wherein the applying step further includes the step of expanding the device to the deployed condition after the device is implanted.

47. The method of claim 46 wherein the expanding step includes expanding the device with a balloon.

48. The method of claim 46 wherein the expanding step includes mechanically expanding the device.

49. A method of treating dilated cardiomyopathy of a heart including the step of applying a force to a discrete localized portion of an atrial wall of a coronary sinus to concentrate the force on a corresponding localized portion of a mitral valve annulus to change the shape of the mitral valve annulus and distributing the applied force along a pericardial wall of the coronary sinus.

50. The method of claim 49 wherein the applying step includes the step of applying the force to a plurality of discrete localized portions of the atrial wall of the coronary sinus while distributing the applied force along the pericardial wall of the coronary sinus.

51. The method of claim 50 wherein the applying step includes the step of implanting a force applying device in the coronary sinus, the device applying the force to the plurality of discrete localized portions of the coronary sinus.

52. The method of claim 51 wherein the device is expandable from a collapsed condition to a deployed condition, wherein the implanting step is carried out while the device is in the collapsed condition, and wherein the applying step further includes the step of expanding the device to the deployed condition after the device is implanted.

53. The method of claim 52 wherein the expanding step includes expanding the device with a balloon.

54. The method of claim 52 wherein the expanding step includes mechanically expanding the device.

55. A mitral valve therapy device configured to be placed in the coronary sinus of a heart adjacent to the mitral valve annulus, the device comprising force applying means for applying an applied force to a discrete portion of the atrial wall of the coronary sinus adjacent to the mitral valve annulus for concentrating the applied force on a discrete portion of the mitral valve annulus.

56. The device of claim 55 wherein the coronary sinus has an unstressed cross-sectional dimension and wherein the force applying means has a cross-sectional dimension greater than the unstressed cross-sectional dimension of the coronary sinus for changing the shape of the mitral valve annulus.

57. The device of claim 55 wherein the force applying means includes means for applying the applied force to a plurality of discrete portions of the atrial wall of the coronary sinus.

58. A mitral valve therapy device configured to be placed in the coronary sinus of a heart adjacent to the mitral valve annulus, the device comprising force applying means for applying an applied force to a discrete portion of the atrial wall of the coronary sinus adjacent to the mitral valve annulus for concentrating the applied force on a discrete portion of the mitral valve annulus, wherein the force applying means is a balloon.

59. A mitral valve therapy device configured to be placed in the coronary sinus of a heart adjacent to the mitral valve annulus, the device comprising force applying means for applying an applied force to a discrete portion of the atrial wall of the coronary sinus adjacent to the mitral valve annulus for concentrating the applied force on a discrete portion of the mitral valve annulus, wherein the mitral valve annulus has a circumference, wherein the coronary sinus has a cross sectional diameter, and wherein the force applying means has an axial length substantially less than half the circumference of the mitral valve annulus and a deployed transverse dimension greater than the diameter of the coronary sinus.

60. A mitral valve therapy device configured to be placed in the coronary sinus of a heart adjacent to the mitral valve annulus, the device comprising force applying means for applying an applied force to a discrete portion of the atrial wall of the coronary sinus adjacent to the mitral valve annulus for concentrating the applied force on a discrete portion of the mitral valve annulus, wherein the device comprises expandable structure means for expanding from a collapsed condition to an expanded deployed condition.

61. The device of claim 60 wherein the expandable structure means is mechanically expandable.

62. The device of claim 60 wherein the expandable structure means is balloon expandable.

63. A mitral valve therapy device configured to be placed in the coronary sinus of a heart adjacent to the mitral valve annulus, the device comprising force applying means for applying an applied force to a discrete portion of the atrial wall of the coronary sinus adjacent to the mitral valve annulus for concentrating the applied force on a discrete portion of the mitral valve annulus, the device further including force distributing means for distributing the applied force along a pericardial wall of the coronary sinus.

64. The device of claim 63 wherein the force distributing means has a surface area, wherein the force applying means has a surface area defining the at least one discrete portion, and wherein the surface area of the force distributing means is greater than the surface area of the force applying means.

65. A mitral valve therapy device configured to be placed in the coronary sinus of a heart adjacent to the mitral valve annulus, the device comprising:

force distributing means for distributing an applied force along a pericardial wall of the coronary sinus; and

force applying means for applying the applied force to at least one discrete portion of a wall of the coronary sinus adjacent to the mitral valve annulus to concentrate the applied force on at least one discrete portion of the mitral valve annulus.