Instruments and methods employing thermal energy for the repair and replacement of cardiac valves

• US 6,355,030 B1
• Filed: 09/25/1998
• Issued: 03/12/2002
• Est. Priority Date: 09/25/1998
• Status: Expired due to Term

• Current Assignee: Recor Medical, Inc. (Otsuka Holdings Company Limited)
• Original Assignee: Cardiothoracic Systems, Inc. (Boston Scientific Corporation)
• Inventors: Helkowski, Richard A., Aldrich, William N., Sepetka, Ivan, Morejohn, Michael V.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/161,079
• Time in Patent Office: 1,264 Days
• Field of Search: 607/96, 607/98-101, 607/27, 607/122, 606/28, 606/29
• US Class Current: 606/28
• CPC Class Codes: A61B 18/08 by means of electrically-heated probes
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2250/0059 temporary

Abstract

The present invention is methods and devices for improving valve function in a heart. Particularly a device of the present invention comprises a an elongate member having a distal end and a proximal end, a thermal heating member fixed to the distal end of the elongate member, wherein the thermal heating member includes at least one thermal heating element adapted to supply thermal energy to a heart valve structure, and an energy source in communication with the thermal heating element. In use, a thermal heating device of the present invention is inserted into working space proximate the valve to be treated and is used to selectively contract the collagen fibers of the valve structure treated so as to improve the performance and functioning of the valve. Devices are disclosed suitable for use with a variety of access procedures on both beating and non-beating hearts, including: a minimally invasive surgical procedure, a sternotomy, a thoracotomy, an endovascular procedure, and endoscopic procedure, or a percutaneous procedure. Methods and devices are disclosed which are suitable for treatment of a chordae, leaflet, or annulus, as well as devices and methods for the replacement of heart valve with prosthetic valves.

Claims

1. An apparatus for supplying non-ablative thermal energy to a heart valve structure comprising:

an elongate member having a distal end and a proximal end, the elongate member configured to allow insertion of the elongate member into a body vessel;

a thermal heating member having a generally concave configuration shaped and proportioned to encompass generally oppositely disposed sides of the structure to be treated fixed to the distal end of the elongate member;

at least one thermal heating element adapted to supply non-ablative thermal energy to a heart valve structure disposed on the thermal heating member; and

a source of non-ablative energy in communication with the thermal heating element.

2. The apparatus of claim 1 wherein the at least one thermal heating element is an electrode in electrical communication with the energy source.

3. The apparatus of claim 1 wherein the thermal heating member includes a transverse groove sized to accommodate a valve chordae.

4. The apparatus of claim 1 including an integrally formed endoscope adapted to visualize an area of interest of the heart valve structure.

5. The apparatus of claim 1 wherein the elongate member includes a vacuum lumen in vacuum communication with a vacuum port disposed on the distal end of the elongate member.

6. The apparatus of claim 5 including a fiber-optic illuminator adapted to illuminate an area of interest on the heart valve structure.

7. The apparatus of claim 1 including a controller configured to selectively control the intensity and duration of thermal energy supplied to the thermal heating element.

8. The apparatus of claim 1 including a temperature sensor adapted to monitor the temperature of the thermal heating element.

9. The apparatus of claim 8 including a feedback control device configured to receive temperature data from the temperature sensor and adjust the supply of energy to the thermal heating element so as to maintain the temperature of the thermal heating element within a preselected temperature range.

10. The apparatus of claim 9 wherein the preselected temperature range is from 40°

to 90°

Celsius.

11. The apparatus of claim 1 including a lumen configured to supply conductive fluid to a heart valve structure to be treated.

12. The apparatus of claim 1 wherein the thermal heating member comprises a hook member sized to engage a valve chordae.

13. The apparatus of claim 12 wherein the hook member is conformable.

14. The apparatus of claim 1 wherein the elongate member and the thermal member are configured to be disposed within a trocar insertion sleeve.

15. The apparatus of claim 14 wherein the thermal heating member comprises a flexible panel member configured to be rolled lengthwise when disposed within the trocar insertion sleeve.

16. The apparatus of claim 14 wherein the elongate member includes a steering means located at the proximal end of the elongate member configured to manipulate at least the distal end of the elongate member.

17. The apparatus of claim 1 wherein the elongate member comprises a flexible cannula configured for endovascular insertion of the elongate member through a body vessel.

18. The apparatus of claim 1 wherein the elongate member comprises an elongate wand.

19. The apparatus of claim 1 wherein the at least one heating element is located on an inner surface of the thermal heating member.

20. An apparatus for supplying non-ablative thermal energy to a heart valve structure comprising:

an elongate member having a distal end and a proximal end, the elongate member configured to allow insertion of the elongate member into a body vessel;

a thermal heating member having a generally annular configuration fixed to the distal end of the elongate member;

at least one thermal heating element adapted to supply non-ablative thermal energy to a heart valve structure disposed on the thermal heating member; and

a source of non-ablative energy in communication with the thermal heating element.

21. The apparatus of claim 20 wherein the thermal heating member comprises an annular configuration sized to approximate the circumference of an annulus.

22. The apparatus of claim 21 wherein the annular configuration has a circumference of between 8.5 to 10 cm.

23. The apparatus of claim 21 wherein the thermal heating member is conformable.

24. The apparatus of claim 21 wherein the apparatus is adapted to be endovascularly delivered proximate the valve structure to be treated.

25. The apparatus of claim 21 wherein the at least one thermal heating element comprises a plurality of thermal heating elements disposed about a circumference of the thermal heating member.

26. The apparatus of claim 21 wherein the annular configuration is concentrically disposed about the elongate member.

27. The apparatus of claim 26 including a plurality of arms circumferentially fixed at a first end about the distal end of the elongate member and circumferentially fixed at a second end to the annular configuration.

28. The apparatus of claim 26 including a fluid impermeable membrane fluidly sealing a cross sectional area of the thermal heating member defined by an inner circumference of the annular configuration and an outer circumference of the elongate member.

29. The apparatus of claim 26 wherein the annular configuration is collapsible about the elongate member.

30. The apparatus of claim 26 including a trocar insertion sleeve adapted to be slidingly disposed about the annular configuration.

31. The apparatus of claim 20 wherein the heating member comprises:

a centrally disposed perfusion tube having a perfusion lumen therethrough, the perfusion lumen fluidly connecting at least one perfusion port formed in a wall of the perfusion tube with a distal end of the perfusion lumen;

an annular configuration concentrically disposed about the perfusion tube and sized to approximate the circumference of an annulus, wherein the at least one thermal heating element comprises a plurality of thermal heating elements disposed about a circumference of the annular configuration; and

a fluid impermeable membrane adapted to fluidly seal a cross sectional area defined by an inner circumference of the annular configuration and an outer circumference of the perfusion tube.

32. The apparatus of claim 31 wherein the perfusion lumen includes a one-way valve configured to prevent fluid flow from the distal end of the perfusion lumen to the at least one perfusion port.

33. The apparatus of claim 31 including an insertion catheter slidingly disposed about the perfusion tube.

34. The apparatus of claim 31 wherein the annular configuration is contractible about the perfusion tube.

35. The apparatus of claim 33 including a plurality of proximal arm members, each proximal arm member having a proximal end fixed to a distal end of the insertion catheter and a distal end fixed to the annular configuration, and a plurality of distal arm members, each distal arm member having a distal end fixed to the perfusion tube and a proximal end fixed to the annular configuration.

36. The apparatus of claim 20 wherein the at least one thermal heating element is an electrode in electrical communication with the energy source.

37. The apparatus of claim 20 including an integrally formed endoscope adapted to visualize an area of interest of the heart valve structure.

38. The apparatus of claim 20 wherein the elongate member includes a vacuum lumen in vacuum communication with a vacuum port disposed on the distal end of the elongate member.

39. The apparatus of claim 38 including a fiber-optic illuminator adapted to illuminate an area of interest on the heart valve structure.

40. The apparatus of claim 20 including a controller configured to selectively control the intensity and duration of thermal energy supplied to the thermal heating element.

41. The apparatus of claim 20 including a temperature sensor adapted to monitor the temperature of the thermal heating element.

42. The apparatus of claim 41 including a feedback control device configured to receive temperature data from the temperature sensor and adjust the supply of energy to the thermal heating element so as to maintain the temperature of the thermal heating element within a preselected temperature range.

43. The apparatus of claim 42 wherein the preselected temperature range is from 40°

to 90°

Celsius.

44. The apparatus of claim 20 including a lumen configured to supply conductive fluid to a heart valve structure to be treated.

45. The apparatus of claim 20 wherein the elongate member and the thermal member are configured to be disposed within a trocar insertion sleeve.

46. The apparatus of claim 45 wherein the elongate member includes a steering means located at the proximal end of the elongate member configured to manipulate at least the distal portion of the elongate member.

47. The apparatus of claim 20 wherein the elongate member comprises a flexible cannula configured for endovascular insertion of the elongate member through a body vessel.

48. The apparatus of claim 20 wherein the elongate member comprises an elongate wand.

49. The apparatus of claim 20 wherein the at least one heating element is located on an inner surface of the thermal heating member.

50. A method of treating a heart valve stricture comprising:

providing a working space proximate a heart valve structure; and

providing non-ablative thermal energy to the heart valve structure so as to selectively contact at least a portion of the heart valve structure;

wherein said step of providing non-ablative thermal energy comprises inserting a thermal treatment apparatus into the working space proximate the structure,

the thermal apparatus comprising an elongate member having a distal end and a proximal end, the elongate member configured to allow insertion of the elongate member into a body vessel;

a thermal heating member having a generally concave configuration shaped and proportioned to encompass generally oppositely disposed sides of the structure to be treated fixed to the distal end of the elongate member;

at least one thermal heating element adapted to supply non-ablative thermal energy to a heart valve structure disposed on the thermal heating member; and

a source of non-ablative energy in communication with the thermal heating element.

51. The method of claim 50 wherein elongate member comprises a wand member configured to be percutaneously delivered to a region of interest proximate the heart valve structure, the step of providing a working space proximate the heart valve structure comprising performing a beating-heart endovascular access procedure.

52. The method of claim 50 wherein the step of contacting the valve structure with the thermal heating element of the thermal heating member comprises contacting an annulus of the heart valve.

53. The method of claim 52 wherein the step of selectively contracting the annulus causes a reduction in the circumference of the annulus.

54. The method of claim 50 including the additional step of monitoring the functioning of the heart valve with a monitoring device substantially simultaneously with providing thermal energy to the heart valve structure.

55. The method of claim 54 wherein the monitoring device comprises a transesophegial echocardiography device, the method including the additional step of installing the device so as to monitor the functioning of the heart valve.

56. The method of claim 50 wherein the step of providing a working space proximate the heart valve structure comprises performing an access procedure chosen from the group consisting of:

a thoracotomy, a sternotomy, a mini-thoracotomy, a mini-sternotomy, a sub-xyphoid access procedure, a xyphoid access procedure, a thorascopic procedure, and an endovascular access procedure.

57. The method of claim 50 including the additional step of placing the heart on cardiopulmonary bypass prior to the step of providing a working space proximate the heart valve structure.

58. The method of claim 50 including the additional step of providing a thermally conductive fluid to at least a portion of the heart valve structure prior to the step of providing thermal energy from the thermal heating element.

59. A method of treating a heart valve structure comprising:

providing a working space proximate a heart valve structure; and

providing non-ablative thermal energy to the heart valve structure so as to selectively contact at least a portion of the heart valve structure;

wherein said step of providing non-ablative thermal energy comprises inserting a thermal treatment apparatus into the working space proximate the structure,

the thermal apparatus comprising an elongate member having a distal end and a proximal end, the elongate member configured to allow insertion of the elongate member into a body vessel;

a thermal heating member having a generally annular configuration fixed to the distal end of the elongate member;

at least one thermal heating element adapted to supply non-ablative thermal energy to a heart valve structure disposed on the thermal heating member; and

a source of non-ablative energy in communication with the thermal heating element.

60. The method of claim 59 wherein elongate member comprises a wand member to be percutaneously delivered to a region of interest proximate the heart valve structure, the step of providing a working space proximate the heart valve structure comprising performing a beating-heart endovascular access procedure.

61. The method of claim 59 wherein the step of contacting the valve structure with the thermal heating element of the thermal member comprises contacting an annulus of the heart valve.

62. The method of claim 61 wherein the step of selectively contracting the annulus causes a reduction in the circumference of the annulus.

63. The method of claim 59 including the additional step of monitoring the functioning of the heart valve with a monitoring device substantially simultaneously with providing thermal energy to the heart valve structure.

64. The method of claim 63, wherein the monitoring device comprises a transesophegial echocardiography device, the method including the additional step of installing the device so as to monitor the functioning of the heart valve.

65. The method of claim 59 wherein the step of providing a working space proximate the heart valve structure comprises performing an access procedure chosen from the group consisting of:

a thoracotomy, a sternotomy, a mini-thoracotomy, a mini-sternotomy, a sub-xyphoid access procedure, a xyphoid access procedure, a thorascopic procedure, and an endovascular access procedure.

66. The method of claim 59 including the additional step of placing the heart on cardiopulmonary bypass prior to the step of providing a working space proximate the heart valve structure.

67. The method of claim 59 including the additional step of providing a thermally conductive fluid to at least a portion of the heart valve structure prior to the step of providing thermal energy from the thermal heating element.

68. An apparatus for supplying non-ablative thermal energy to a heart valve structure comprising:

an elongate member having a distal end and a proximal end, the elongate member configured to allow insertion of the elongate member into a body vessel;

a thermal heating member having a generally concavedly curved or annular configuration fixed to the distal end of the elongate member;

at least one thermal heating element adapted to supply non-ablative thermal energy to a heart valve structure disposed on the thermal heating member; and

a source of non-ablative energy in communication with the thermal heating element;

wherein the thermal heating member includes a transverse groove sized to accommodate a valve chordae.

69. An apparatus for supplying non-ablative thermal energy to a heart valve structure comprising:

an elongate member having a distal end and a proximal end, the elongate member configured to allow insertion of the elongate member into a body vessel;

a thermal heating member having a generally concavedly curved or annular configuration fixed to the distal end of the elongate member;

at least one thermal heating element adapted to supply non-ablative thermal energy to a heart valve structure disposed on the thermal heating member;

a source of non-ablative energy in communication with the thermal heating element; and

an integrally formed endoscope adapted to visualize the area of interest of the heart valve structure.

70. An apparatus for supplying non-ablative thermal energy to a heart valve structure comprising:

an elongate member having a distal end and a proximal end, the elongate member configured to allow insertion of the elongate member into a body vessel, wherein the elongate member includes a vacuum lumen in vacuum communication with a vacuum port disposed on the distal end of the elongate member;

a thermal heating member having a generally concavedly curved or annular configuration fixed to the distal end of the elongate member;

at least one thermal heating element adapted to supply non-ablative thermal energy to a heart valve structure disposed on the thermal heating member; and

a source of non-ablative energy in communication with the thermal heating element.

71. The apparatus of claim 70, including a fiber-optic illuminator adapted to illuminate an area of interest on the heart valve structure.

72. An apparatus for supplying non-ablative thermal energy to a heart valve structure comprising:

an elongate member having a distal end and a proximal end, the elongate member configured to allow insertion of the elongate member into a body vessel;

a thermal heating member having a generally concavedly curved or annular configuration fixed to the distal end of the elongate member;

at least one thermal heating element adapted to supply non-ablative thermal energy to a heart valve structure disposed on the thermal heating member;

a source of non-ablative energy in communication with the thermal heating element; and

a lumen configured to supply conductive fluid to a heart valve structure to be treated.

73. An apparatus for supplying non-ablative thermal energy to a heart valve structure comprising:

an elongate member having a distal end and a proximal end, the elongate member configured to allow insertion of the elongate member into a body vessel;

a thermal heating member having a generally concavedly curved or annular configuration fixed to the distal end of the elongate member, wherein the thermal heating member comprises a hook member sized to engage a valve chordae;

at least one thermal heating element adapted to supply non-ablative thermal energy to a heart valve structure disposed on the thermal heating member; and

a source of non-ablative energy in communication with the thermal heating element.

74. The apparatus of claim 73 wherein the hook member is conformable.

75. An apparatus for supplying non-ablative thermal energy to a heart valve structure comprising:

an elongate member having a distal end and a proximal end, the elongate member configured to allow insertion of the elongate member into a body vessel;

a thermal heating member having a generally concavedly curved or annular configuration fixed to the distal end of the elongate member;

at least one thermal heating element adapted to supply non-ablative thermal energy to a heart valve structure disposed on the thermal heating member; and

a source of non-ablative energy in communication with the thermal heating element;

wherein the elongate member and the thermal heating member are configured to be disposed within a trocar insertion sleeve.

76. The apparatus of claim 75 wherein the thermal heating member comprises a flexible panel member configured to be rolled lengthwise when disposed within the trocar insertion sleeve.

77. The apparatus of claim 75 wherein the elongate member includes a steering means located at the proximal end of the elongate member configured to manipulate at least the distal portion of the elongate member.

78. An apparatus for supplying non-ablative thermal energy to a heart valve structure comprising:

an elongate member having a distal end and a proximal end, the elongate member configured to allow insertion of the elongate member into a body vessel;

a thermal heating member having a generally concavedly curved or annular configuration fixed to the distal end of the elongate member;

at least one thermal heating element adapted to supply non-ablative thermal energy to a heart valve structure disposed on the thermal heating member; and

a source of non-ablative energy in communication with the thermal heating element;

wherein the thermal heating member comprises an annular configuration sized to approximate the circumference of an annulus.

79. The apparatus of claim 78 wherein the annular configuration has a circumference of between 8.5 to 10 cm.

80. The apparatus of claim 78 wherein the thermal heating member is conformable.

81. The apparatus of claim 78 wherein the apparatus is adapted to be endovascularly delivered proximate the valve structure to be treated.

82. The apparatus of claim 78 wherein the at least one thermal heating element comprises a plurality of thermal heating elements disposed about a circumference of the thermal heating member.

83. The apparatus of claim 78 wherein the annular configuration is concentrically disposed about the elongate member.

84. The apparatus of claim 83 including a plurality of arms circumferentially fixed at a first end about the distal end of the elongate member and circumferentially fixed at a second end to the annular configuration.

85. The apparatus of claim 83 including a fluid impermeable membrane fluidly sealing a cross sectional area of the thermal heating member defined by an inner circumference of the annular configuration and an outer circumference of the elongate member.

86. The apparatus of claim 83 wherein the annular configuration is collapsible about the elongate member.

87. The apparatus of claim 83 including a trocar insertion sleeve adapted to be slidingly disposed about the annular configuration.

88. An apparatus for supplying non-ablative thermal energy to a heart valve structure comprising:

an elongate member having a distal end and a proximal end, the elongate member configured to allow insertion of the elongate member into a body vessel;

a thermal heating member having a generally concavedly curved or annular configuration fixed to the distal end of the elongate member;

at least one thermal heating element adapted to supply non-ablative thermal energy to a heart valve structure disposed on the thermal heating member; and

a source of non-ablative energy in communication with the thermal heating element;

wherein the heating member comprises a centrally disposed perfusion tube having a perfusion lumen therethrough, the perfusion lumen fluidly connecting at least one perfusion port formed in a wall of the perfusion tube with a distal end of the perfusion lumen, an annular configuration concentrically disposed about the perfusion tube and sized to approximate the circumference of an annulus, wherein the at least one thermal heating element comprises a plurality of thermal heating elements disposed about a circumference of the annular configuration, and a fluid impermeable membrane adapted to fluidly seal a cross sectional area defined by an inner circumference of the annular configuration and an outer circumference of the perfusion tube.

89. The apparatus of claim 88 wherein the perfusion lumen includes a one-way valve configured to prevent fluid flow from the distal end of the perfusion lumen to the at least one perfusion port.

90. The apparatus of claim 88 including an insertion catheter slidingly disposed about the perfusion tube.

91. The apparatus of claim 90 including a plurality of proximal arm members, each proximal arm member having a proximal end fixed to a distal end of the insertion catheter and a distal end fixed to the annular configuration, and a plurality of distal arm members, each distal arm member having a distal end fixed to the perfusion tube and a proximal end fixed to the annular configuration.

92. The apparatus of claim 88 wherein the annular configuration is contractible about the perfusion tube.

93. A method of treating a heart valve structure comprising:

providing a working space proximate a heart valve structure; and

providing non-ablative thermal energy to the heart valve structure so as to selectively contact at least a portion of the heart valve structure;

wherein said step of providing non-ablative thermal energy comprises inserting a thermal treatment apparatus into the working space proximate the structure,

the thermal apparatus comprising an elongate member having a distal end and a proximal end, the elongate member configured to allow insertion of the elongate member into a body vessel;

a thermal heating member having a generally concavedly curved or annular configuration fixed to the distal end of the elongate member;

at least one thermal heating element adapted to supply non-ablative thermal energy to a heart valve structure disposed on the thermal heating member; and

a source of non-ablative energy in communication with the thermal heating element, and

the elongate member comprises a wand member configured to be percutaneously delivered to a region of interest proximate the heart valve structure, the step of providing a working space proximate the heart valve structure comprising performing a beating-heart endovascular access procedure.

94. A method of treating a heart valve structure comprising:

providing a working space proximate a heart valve structure;

providing non-ablative thermal energy to the heart valve structure so as to selectively contact at least a portion of the heart valve structure; and

monitoring the functioning of the heart valve with a monitoring device substantially simultaneously with providing thermal energy to the heart valve structure;

wherein said step of providing non-ablative thermal energy comprises inserting a thermal treatment apparatus into the working space proximate the structure,

the thermal apparatus comprising an elongate member having a distal end and a proximal end, the elongate member configured to allow insertion of the elongate member into a body vessel;

a thermal heating member having a generally concavedly curved or annular configuration fixed to the distal end of the elongate member;

at least one thermal heating element adapted to supply non-ablative thermal energy to a heart valve structure disposed on the thermal heating member; and

a source of non-ablative energy in communication with the thermal heating element.

95. The method of claim 94 wherein the monitoring device comprises a transesophegial echocardiography device, the method including the additional step of installing the device so as to monitor the functioning of the heart valve.

96. A method of treating a heart valve structure comprising:

providing a working space proximate a heart valve structure; and

providing non-ablative thermal energy to the heart valve structure so as to selectively contact at least a portion of the heart valve structure;

wherein said step of providing non-ablative thermal energy comprises inserting a thermal treatment apparatus into the working space proximate the structure,

the thermal apparatus comprising an elongate member having a distal end and a proximal end, the elongate member configured to allow insertion of the elongate member into a body vessel;

a thermal heating member having a generally concavedly curved or annular configuration fixed to the distal end of the elongate member;

at least one thermal heating element adapted to supply non-ablative thermal energy to a heart valve structure disposed on the thermal heating member; and

a source of non-ablative energy in communication with the thermal heating element, and

wherein the step of providing a working space proximate the heart valve structure comprises performing an access procedure chosen from the group consisting of;

a thoracotomy, a sternotomy, a mini-thoracotomy, a mini-sternotomy, a sub-xyphoid access procedure, a xyphoid access procedure, a thorascopic procedure, and an endovascular access procedure.

97. An apparatus for supplying non-ablative thermal energy to a heart valve structure comprising:

an elongate member having a distal end and a proximal end, the elongate member configured to allow insertion of the elongate member into a body vessel;

a thermal heating member having a generally concavedly curved or annular configuration fixed to the distal end of the elongate member;

at least one thermal heating element adapted to supply non-ablative thermal energy to a heart valve structure disposed on the thermal heating member; and

a source of non-ablative energy in communication with the thermal heating element;

wherein the elongate member comprises a flexible cannula configured for endovascular insertion of the elongate member through a body vessel.

98. An apparatus for supplying non-ablative thermal energy to a heart valve structure comprising:

an elongate member having a distal end and a proximal end, the elongate member configured to allow insertion of the elongate member into a body vessel;

a thermal heating member having a generally concavedly curved or annular configuration fixed to the distal end of the elongate member;

at least one thermal heating element adapted to supply non-ablative thermal energy to a heart valve structure disposed on the thermal heating member; and

a source of non-ablative energy in communication with the thermal heating element;

wherein the elongate member comprises an elongate wand.

99. A method of treating a heart valve structure comprising:

providing a working space proximate a heart valve structure; and

providing non-ablative thermal energy to the heart valve structure so as to selectively contact at least a portion of the heart valve structure;

wherein said step of providing non-ablative thermal energy comprises inserting a thermal treatment apparatus into the working space proximate the structure,

the thermal apparatus comprising an elongate member having a distal end and a proximal end, the elongate member configured to allow insertion of the elongate member into a body vessel;

a thermal heating member having a generally concavedly curved or annular configuration fixed to the distal end of the elongate member;

at least one thermal heating element adapted to supply non-ablative thermal energy to a heart valve structure disposed on the thermal heating member; and

a source of non-ablative energy in communication with the thermal heating element, and

wherein the step of contacting the valve structure with the thermal heating element of the thermal heating member comprises contacting an annulus of the heart valve.

100. The method of claim 99, wherein the step of selectively contracting the annulus causes a reduction in the circumference of the annulus.

101. A method of treating a heart valve structure comprising:

providing a working space proximate a heart valve structure;

providing non-ablative thermal energy to the heart valve structure so as to selectively contact at least a portion of the heart valve structure; and

placing the heart on cardiopulmonary bypass prior to the step of providing a working space proximate the heart valve structure;

wherein said step of providing non-ablative thermal energy comprises inserting a thermal treatment apparatus into the working space proximate the structure,

the thermal apparatus comprising an elongate member having a distal end and a proximal end, the elongate member configured to allow insertion of the elongate member into a body vessel;

a thermal heating member having a generally concavedly curved or annular configuration fixed to the distal end of the elongate member;

at least one thermal heating element adapted to supply non-ablative thermal energy to a heart valve structure disposed on the thermal heating member; and

a source of non-ablative energy in communication with the thermal heating element.

102. A method of treating a heart valve structure comprising:

providing a working space proximate a heart valve structure;

providing non-ablative thermal energy to the heart valve structure so as to selectively contact at least a portion of the heart valve structure; and

providing a thermally conductive fluid to at least a portion of the heart valve structure prior to the step of providing thermal energy from the thermal heating element;

wherein said step of providing non-ablative thermal energy comprises inserting a thermal treatment apparatus into the working space proximate the structure, the thermal apparatus comprising an elongate member having a distal end and a proximal end, the elongate member configured to allow insertion of the elongate member into a body vessel;

a thermal heating member having a generally concavedly curved or annular configuration fixed to the distal end of the elongate member;

at least one thermal heating element adapted to supply non-ablative thermal energy to a heart valve structure disposed on the thermal heating member; and

a source of non-ablative energy in communication with the thermal heating element.