Remotely activated mitral annuloplasty system and methods

• US 20050060030A1
• Filed: 07/19/2004
• Published: 03/17/2005
• Est. Priority Date: 01/31/2000
• Status: Active Grant

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: von Hoffmann, Gerard, Kusleika, Richard S., Lashinski, Randall T., Taylor, David Mark, Forman, Michael R.
• Granted Patent: US 7,695,512 B2
• Time in Patent Office: Days
• US Class Current: 623/2.370
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants

Abstract

Disclosed are implants and methods for remote remodeling of a mitral valve annulus. The implant comprises a body transformable from a flexible configuration for navigation to a treatment site, to a remodeling configuration for, in one application, applying pressure to the posterior leaflet of the mitral valve. On board electronics allow post deployment adjustment of the implant.

Claims

1. An implant for applying pressure to the mitral valve annulus of a patient, comprising:

a body, adjustable between a first configuration to allow positioning in the vicinity of the mitral valve, and a second configuration for applying pressure on the mitral valve annulus; and

an electronically driven actuator, for adjusting the implant.

2. An implant for applying pressure to the mitral valve annulus as in claim 1, wherein the actuator comprises a motor.

3. An implant for applying pressure to the mitral valve annulus as in claim 1, further comprising a receiver for receiving a control signal from a source external to the patient.

4. An implant for applying pressure to the mitral valve annulus as in claim 3, wherein the receiver is an RF receiver.

5. An implant for applying pressure to the mitral valve annulus as in claim 1, further comprising a transmitter for transmitting information to a receiver external to the patient.

6. An implant for applying pressure to the mitral valve annulus as in claim 5, wherein the information indicates implant configuration.

7. An implant for applying pressure to the mitral valve annulus as in claim 5, wherein the information includes at least one physiological parameter.

8. An implant for applying pressure to the mitral valve annulus as in claim 5, wherein the information indicates hemodynamic function.

9. An implant for applying pressure to the mitral valve annulus as in claim 1, further comprising a power source.

10. An implant for applying pressure to the mitral valve annulus as in claim 9, wherein the power source is carried by the implant.

11. An implant for applying pressure to the mitral valve annulus as in claim 10, wherein the power source is in electrical communication with the implant.

12. An implant for applying pressure to the mitral valve annulus as in claim 1, further comprising a mechanical coupling, for allowing mechanical adjustment of the implant using a deployment catheter.

13. An implant for applying pressure to the mitral valve annulus as in claim 1, wherein the actuator causes lateral movement of a portion of the implant, for advancing the posterior leaflet of the mitral valve in an anterior direction.

14. An implant for applying pressure to the mitral valve annulus as in claim 13, wherein the portion is adjacent an end of the implant.

15. An implant for applying pressure to the mitral valve annulus as in claim 13, wherein the portion is located in between a proximal end and a distal end of the implant.

16. An implant for applying pressure to the mitral valve annulus as in claim 14, wherein the implant is advanceable into a “

c”

configuration in response to actuation of the actuator.

17. An implant for applying pressure to the mitral valve annulus as in claim 15, wherein the implant is advanceable into a “

w”

configuration in response to actuation of the actuator.

18. An implant for applying pressure to the mitral valve annulus as in claim 2, wherein the motor is a stepper motor.

19. An implant for applying pressure to the mitral valve annulus as in claim 1, wherein the actuator is reversibly adjustable to apply pressure to or relieve pressure from the mitral valve annulus.

20. An implant for applying pressure to the mitral valve annulus as in claim 1, further comprising at least two electrical conductors for electrically connecting the implant to an external control.

21. An implant for applying pressure to the mitral valve annulus as in claim 20, wherein one of the electrical conductors is the patient'"'"'s body.

22. A medical apparatus for remodeling a mitral valve annulus adjacent to the coronary sinus, comprising:

an elongate body, having a proximal end and a distal end, the elongate body being movable from a first, flexible configuration for transluminal delivery to at least a portion of the coronary sinus to a second configuration for remodeling the mitral valve annulus; and

an electronically driven module attached to the elongate body for transforming the elongate body between the first delivery configuration and the second remodeling configuration.

23. A medical apparatus as in claim 22, wherein the elongate body in the second, remodeling configuration comprises at least a first curve which is concave in a first direction.

24. A medical apparatus as in claim 23, wherein the body when in the second configuration comprises a second curve which is concave in a second direction.

25. A medical apparatus as in claim 22, wherein the elongate body comprises a tube having a plurality of transverse slots therein.

26. A medical apparatus as in claim 22, wherein the apparatus is movable from the first configuration to the second configuration in response to activation of a motor in the module.

27. A medical apparatus as in claim 22, further comprising at least one anchor carried by the body for engaging a site within a vessel.

28. A medical apparatus as in claim 27, wherein the anchor comprises at least one barb for piercing the wall of the vessel.

29. A medical apparatus as in claim 28, comprising a first tissue anchor at the proximal end and a second tissue anchor at the distal end.

30. A medical apparatus as in claim 29, wherein the apparatus has an axial length of no more than about 10 cm.

31. A medical apparatus as in claim 29, wherein the maximum cross sectional dimension through the apparatus is no more than about 10 mm.

32. An implant for positioning within a patient, comprising:

an elongate flexible body;

an electronically actuated forming element extending through at least a portion of the body; and

a detachable coupling on the body, for removably attaching the body to a deployment catheter;

wherein manipulation of the forming element deflects at least a first portion of the body with respect to at least a second portion of the body.

33. An implant as in claim 32, wherein the body comprises a tubular wall.

34. An implant as in claim 33, wherein the tubular wall is substantially noncompressible along a first side.

35. An implant as in claim 34, comprising a plurality of voids in the wall along a second side, thereby permitting axial shortening or elongation of the second side.

36. An implant as in claim 35 wherein at least some of the voids comprise slots through the wall, extending generally transverse to a longitudinal axis.

37. An implant as in claim 36 comprising at least 10 transverse slots in the wall of the second side.

38. An implant as in claim 37 comprising at least 20 transverse slots in the wall of the second side.

39. A method of manipulating the mitral valve, comprising the steps of:

providing a catheter, having a prosthesis thereon, the prosthesis having a first tissue anchor and a second tissue anchor;

inserting the catheter into the venous system;

transluminally advancing the prosthesis into the coronary sinus;

attaching the first and second tissue anchors to the wall of the coronary sinus; and

manipulating the prosthesis to exert a lateral force on the wall of the coronary sinus in between the first and second tissue anchors;

wherein at least one of the attaching and the manipulating steps includes the step of activating an electrical circuit.

40. A method as in claim 39, wherein the activating an electronic circuit step comprises transmitting an electrical signal through the catheter.

41. A method as in claim 39, wherein the activating an electronic circuit step comprises transmitting an RF signal to the prosthesis.

42. A method as in claim 39, further comprising the step of percutaneously accessing the venous system prior to the transluminally advancing step.

43. A method as in claim 42, wherein the accessing step is accomplished by accessing one of the internal jugular, subclavian and femoral veins.

44. A method as in claim 39, further comprising the steps of first measuring the coronary sinus and then selecting an appropriately sized prosthesis prior to the inserting step.

45. A method as in claim 39, further comprising the step of measuring hemodynamic function following the manipulating step.

46. A method as in claim 45, further comprising the step of determining an ongoing drug therapy taking into account the post implantation hemodynamic function.

47. A method of providing a therapeutic compressive force against a tissue structure which is adjacent the implant, comprising the steps of positioning a device at a target site in a patient;

and electronically actuating the device to cause a portion of the device to move, thereby exerting a force against the adjacent tissue structure.

48. A method as in claim 47, wherein the positioning step is accomplished translumenally.

49. A method as in claim 47, wherein the positioning step is accomplished through an artificial tissue tract.

50. A method as in claim 47, wherein the positioning step is accomplished percutaneously.

51. A method as in claim 47, wherein the tissue structure comprises the mitral valve annulus.

52. A method as in claim 47, wherein the tissue structure comprises the left ventricle.

53. A method as in claim 48, wherein the positioning step comprises advancing the device translumenally through a vein.

54. A method as in claim 53, wherein the positioning step comprises advancing the device translumenally through the coronary sinus.

55. A method as in claim 50, wherein the positioning step comprises percutaneously accessing the venous system prior to the positioning step.

56. A method as in claim 55, wherein the accessing step is accomplished by accessing one of the internal jugular, subclavian and femoral veins.

57. A method as in claim 47, further comprising the steps of measuring the coronary sinus and then selecting an appropriately sized prosthesis prior to the positioning step.

58. A method as in claim 47, further comprising the step of measuring hemodynamic function following the actuating step.

59. A method as in claim 58, further comprising the step of determining an ongoing drug therapy taking into account the post implantation hemodynamic function.

60. A method of treating a patient, comprising the steps of identifying a patient with an implant;

and electronically actuating the implant to adjust an amount of force exerted by the implant against adjacent tissue.

61. A method of treating a patient as in claim 60, wherein the electronically actuating step comprises sending an RF signal to the implant.

62. A method of treating a patient as in claim 60, wherein the electronically actuating step adjusts force against a heart valve.

63. A method of treating a patient as in claim 62, wherein the electronically actuating step adjusts force against the annulus of the mitral valve.

64. A method of treating a patient as in claim 63, wherein the electronically actuating step adjusts the position of the posterior leaflet of the mitral valve.

65. A method of treating a patient as in claim 60, wherein the electronically actuating step adjusts force against a natural body lumen.

66. A method of treating a patient as in claim 60, wherein the electronically actuating step adjusts force against the lower esophageal sphincter.

67. A method of treating a patient as in claim 60, wherein the electronically actuating step adjusts force against the stomach.

68. A method of treating a patient as in claim 60, wherein the electronically actuating step adjusts force against the urethra.

69. A method of treating a patient as in claim 60, wherein the electronically actuating step adjusts force against a nerve.

70. A method of treating a patient as in claim 60, wherein the electronically actuating step is accomplished at least ten minutes following implantation of the implant into the patient.

71. A method of treating a patient as in claim 60, wherein the electronically actuating step is accomplished at least 24 hours following implantation of the implant into the patient.

72. A method of treating a patient as in claim 60, wherein the electronically actuating step is accomplished at least two weeks following implantation of the implant into the patient.

73. A method of treating a patient as in claim 60, further comprising the step of measuring an indicium of the patient'"'"'s condition prior to the electronically actuating step.

74. A method of treating a patient as in claim 60, additionally comprising the step of monitoring hemodynamic function.

75. A method as in claim 74, wherein the monitoring step is accomplished using transesophageal echo cardiography.

76. A method as in claim 74, wherein the monitoring step is accomplished using surface echo cardiographic imaging.

77. A method as in claim 74, wherein the monitoring step is accomplished using intracardiac echo cardiographic imaging.

78. A method as in claim 74, wherein the monitoring step is accomplished using fluoroscopy with radiocontrast media.

79. A method as in claim 74, wherein the monitoring step is accomplished using left atrial or pulmonary capillary wedge pressure measurements.

80. A method as in claim 74, further comprising the step of determining an ongoing drug therapy taking into account hemodynamic function.

81. A method as in claim 63, comprising measuring residual regurgitation following the electronically actuating step and formulating an ongoing drug therapy taking into account the residual regurgitation.

82. A method of treating a patient, comprising positioning a selectively actuatable motion source in the coronary sinus.