Remotely adjustable coronary sinus implant

• US 20050222678A1
• Filed: 04/05/2004
• Published: 10/06/2005
• Est. Priority Date: 04/05/2004
• Status: Active Grant

• Current Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences AG (Edwards Lifesciences Corporation)
• Inventors: Kusleika, Richard S., Lashinski, Randall T., Taylor, David Mark
• Granted Patent: US 7,993,397 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape

Abstract

Disclosed are methods and devices for applying pressure to an adjacent tissue structure, such as the annulus of the mitral valve. An adjustable implant is provided with an elongate control line having a distal end connected to the implant and a proximal end spaced apart from the implant. The device enables post implantation adjustment, by accessing the proximal end of the control line and manipulating the control line to adjust the implant.

Claims

1. A system for remodeling a mitral valve annulus, comprising:

a delivery catheter;

an implant, detachably carried by the delivery catheter, the implant reversibly movable between a first, flexible configuration for delivery to a site adjacent the annulus of the mitral valve and a second, rigid configuration for remodeling the mitral valve annulus;

an elongate flexible control line having a first end attached to the implant and a second end spaced apart from the implant; and

a coupling on the second end for releasable coupling to an adjustment tool.

2. A system as in claim 1, wherein the implant comprises an arc when in the remodeling configuration.

3. A system as in claim 2, wherein a best fit constant radius curve corresponding to the arc has a radius within the range of from about 10 mm to about 20 mm.

4. A system as in claim 2, wherein the implant comprises a compound curve when in the remodeling configuration.

5. A system as in claim 4, wherein the compound curve comprises a “

w”

configuration.

6. A system as in claim 1, further comprising a coating on the implant.

7. A system as in claim 1, further comprising an anchor for retaining the implant at a deployment site.

8. A system as in claim 7, wherein the anchor comprises a distal extension of the implant.

9. A system as in claim 7, wherein the anchor comprises a friction enhancing surface structure for engaging adjacent tissue.

10. A system as in claim 7, wherein the anchor comprises at least one barb for piercing the wall of the vessel.

11. A system as in claim 10, wherein the barb is moveable between an axial orientation and an inclined orientation.

12. A system as in claim 1, wherein the control line comprises an elongate flexible body having at least one lumen extending therethrough.

13. A system as in claim 12 further comprising a control element extending axially through the lumen.

14. A system as in claim 13, wherein the implant is adjustable in response to rotation of the control element.

15. A system as in claim 13, wherein the implant is adjustable in response to axial movement of the control element.

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

an elongate body, having a proximal end region and a distal end region, each of the proximal and distal end regions dimensioned to reside completely within the vascular system, the elongate body being movable from a first configuration for transluminal delivery to at least a portion of the coronary sinus to a second configuration for remodeling the mitral valve annulus proximate the coronary sinus; and

an elongate flexible control line having a first end attached to the elongate body, for manipulating the elongate body between the first transluminal configuration to the second remodeling configuration; and

a second, free end on the control line;

wherein the elongate body comprises a tube having a plurality of transverse slots therein.

17. A medical apparatus as in claim 16, wherein the elongate body forms an arc when in the remodeling configuration, by changing the shape of the slots.

18. A medical apparatus as in claim 17, wherein a best fit constant radius curve corresponding to the arc has a radius within the range of from about 10 mm to about 20 mm.

19. A medical apparatus as in claim 16, further comprising a lock for retaining the body in the second configuration.

20. A medical apparatus as in claim 16, wherein the apparatus is movable between the implantation configuration and the remodeling configuration in response to proximal retraction of a portion of the control line.

21. A medical apparatus as in claim 16, wherein the apparatus is movable between the implantation configuration and the remodeling configuration in response to rotation of a portion of the control line.

22. A medical apparatus as in claim 16, further comprising an anchor for retaining the apparatus at a deployment site within a vessel.

23. A medical apparatus as in claim 22, wherein the anchor comprises a distal extension of the apparatus.

24. A medical apparatus as in claim 22, wherein the anchor comprises a friction enhancing surface structure for engaging the wall of the vessel.

25. A medical apparatus as in claim 22, wherein the anchor comprises at least one barb for piercing the wall of the vessel.

26. A medical apparatus as in claim 16, wherein the apparatus has an axial length of no more than about 10 cm.

27. A medical apparatus as in claim 26, wherein the maximum cross sectional dimension through the apparatus is no more than about 10 mm.

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

an elongate flexible body having a proximal end and a distal end, and a longitudinal axis extending therebetween, and first and second opposing sides extending along the implant body at least part way between the proximal end and the distal end, the first side having a fixed axial length, and the second side having an adjustable axial length;

at least a first forming element extending through the body to a distal point of attachment to the body; and

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

wherein manipulation of the first forming element deflects at least a first portion of the body away from the longitudinal axis.

29. An implant as in claim 28, wherein the body comprises a tubular wall.

30. An implant as in claim 29, wherein the tubular wall is substantially noncompressible along the first side.

31. An implant as in claim 30, comprising a plurality of voids in the wall along the second side, thereby permitting axial shortening of the second side.

32. An implant as in claim 31 wherein at least some of the voids comprise slots through the wall, extending generally transverse to the longitudinal axis.

33. An implant as in claim 32 comprising at least 10 transverse slots in the wall of the second side.

34. An implant as in claim 32 comprising at least 20 transverse slots in the wall of the second side.

35. An implant as in claim 28, wherein the first forming element comprises an axially movable element.

36. A method of treating a patient, comprising the steps of:

identifying a patient having a control line connected to an implant residing within the patient;

accessing the control line at a site on the patient that is remote from the implant; and

manipulating the control line to adjust extravascular presure exerted by the implant.

37. A method of treating a patient as in claim 36, wherein the identifying step comprises identifying a patient having an intravascular implant.

38. A method of treating a patient as in claim 37, wherein the implant resides within the coronary sinus.

39. A method of treating a patient as in claim 38, wherein the manipulating step changes pressure exerted by the implant on the mitral valve.

40. A method of treating a patient, comprising the steps of:

locating a control line positioned subcutaneously on the patient;

exposing a portion of the control line; and

manipulating the control line to mechanically change the hemodynamic function of a heart valve.

41. A method of treating a patient as in claim 40, wherein the manipulating step comprises connecting an adjustment tool to the control line and using the adjustment tool to manipulate the control line.

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

the device connected by an elongate, flexible control line to a remote connector;

coupling an adjustment tool to the connector; and

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

43. A method as in claim 42, wherein the positioning step is accomplished translumenally.

44. A method as in claim 42, wherein the positioning step is accomplished through an artificial tissue tract.

45. A method as in claim 42, wherein the positioning step is accomplished percutaneously.

46. A method as in claim 42, wherein the tissue structure comprises the mitral valve annulus.

47. A method as in claim 42, wherein the tissue structure comprises the left ventricle.

48. A method as in claim 46, wherein the positioning step comprises advancing the device translumenally through a vein.

49. A method as in claim 48, wherein the positioning step comprises advancing the device translumenally into the coronary sinus.

50. A method as in claim 49, wherein the positioning step comprises percutaneously accessing the venous system prior to the positioning step.

51. A method as in claim 50, wherein the accessing step is accomplished by accessing one of the internal jugular, subclavian and femoral veins.

52. A method as in claim 49, further comprising the steps of measuring the coronary sinus and then selecting an appropriately sized prosthesis prior to the positioning step.

53. A method as in claim 42, further comprising the step of measuring hemodynamic function following the actuating step.

54. A method as in claim 53, further comprising the step of determining an ongoing drug therapy taking into account the post implantation hemodynamic function.

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

accessing a connector which is connected to the implant by an elongate, flexible tubular sleeve having a control line therein;

connecting an adjustment tool to the connector and actuating the adjustment tool to adjust an amount of force exerted by the implant against adjacent tissue.

56. A method of treating a patient as in claim 55, wherein the actuating step adjusts force against a heart valve.

57. A method of treating a patient as in claim 56, wherein the actuating step adjusts force against the annulus of the mitral valve.

58. A method of treating a patient as in claim 57, wherein the actuating step adjusts the position of the posterior leaflet of the mitral valve.

59. A method of treating a patient as in claim 55, wherein the actuating step adjusts force against a natural body lumen.

60. A method of treating a patient as in claim 55, wherein the actuating step adjusts force against the lower esophageal sphincter.

61. A method of treating a patient as in claim 55, wherein the actuating step adjusts force against the stomach.

62. A method of treating a patient as in claim 55, wherein the actuating step adjusts force against the urethra.

63. A method of treating a patient as in claim 55, wherein the actuating step adjusts force against a nerve.

64. A method of treating a patient as in claim 55, wherein the actuating step is accomplished at least ten minutes following implantation of the implant into the patient.

65. A method of treating a patient as in claim 64, wherein the actuating step is accomplished at least 24 hours following implantation of the implant into the patient.

66. A method of treating a patient as in claim 65, wherein the actuating step is accomplished at least two weeks following implantation of the implant into the patient.

67. A method of treating a patient as in claim 55, further comprising the step of measuring an indicium of the patient'"'"'s condition prior to the actuating step.

68. A method of treating a patient as in claim 55, additionally comprising the step of monitoring hemodynamic function.

69. A method as in claim 68, wherein the monitoring step is accomplished using transesophageal echo cardiography.

70. A method as in claim 68, wherein the monitoring step is accomplished using surface echo cardiographic imaging.

71. A method as in claim 68, wherein the monitoring step is accomplished using intracardiac echo cardiographic imaging.

72. A method as in claim 68, wherein the monitoring step is accomplished using fluoroscopy with radiocontrast media.

73. A method as in claim 68, wherein the monitoring step is accomplished using left atrial or pulmonary capillary wedge pressure measurements.

74. A method as in claim 68, further comprising the step of determining an ongoing drug therapy taking into account hemodynamic function.

75. A method as in claim 55, comprising measuring residual regurgitation following the actuating step and formulating an ongoing drug therapy taking into account the residual regurgitation.