System and methods for selective thermal treatment

• US 20060167398A1
• Filed: 01/25/2005
• Published: 07/27/2006
• Est. Priority Date: 01/25/2005
• Status: Active Grant

• Current Assignee: Thermopeutix Inc.
• Original Assignee: Thermopeutix Inc.
• Inventors: Solar, Ronald J., Lieber, Glen
• Granted Patent: US 7,789,846 B2
• Time in Patent Office: Days
• US Class Current: 604/6.130
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities
• CPC Class Codes: A61M 1/3613 Reperfusion, e.g. of the coronary vessels, e.g. retroperfusion
• CPC Class Codes: A61M 1/369 Temperature treatment

Abstract

Systems and methods for selective cooling of a target site include a catheter having a supply lumen and a delivery lumen, with inlet and exit ports. Blood is withdrawn from the supply lumen and cooled or heated in a control unit. The treated blood is sent to the targeted area via delivery lumen. The supply lumen can act as an insulator for the delivery lumen.

Claims

1. A system for providing selective thermal therapy, the system comprising:

a first lumen having a distal end and a proximal end;

an exit port located on said first lumen;

an occlusion element positioned on said first lumen, proximal to said exit port;

a second lumen coaxial to said first lumen, said second lumen having a proximal end and a distal end;

a second port positioned on said second lumen, said second port proximal to said occlusion element; and

a control unit in fluid communication with said proximal ends of said first lumen and said second lumen.

2. The system of claim 1, wherein said first lumen is a delivery lumen for delivering thermally treated blood to a target site in the body.

3. The system of claim 1, wherein said exit port is located at said distal end of said first lumen.

4. The system of claim 1, wherein said exit port is located proximal to said distal end of said first lumen, and further comprising a second occlusion element between said exit port and said distal end of said first lumen.

5. The system of claim 1, wherein said occlusion element is a balloon.

6. The system of claim 1 wherein said occlusion element has an atraumatic surface.

7. The system of claim 1, wherein said occlusion element includes a hydrophilic coating.

8. The system of claim 1, wherein said occlusion element includes a drug coating.

9. The system of claim 1, wherein said occlusion element is a mechanically expandable device.

10. The system of claim 1, wherein said occlusion element is a spring loaded device.

11. The system of claim 1, wherein said occlusion element includes a shape memory alloy.

12. The system of claim 1, wherein said second lumen is a supply lumen for providing normothermal blood to said control unit and said second port is an inlet port.

13. The system of claim 12, wherein said inlet port comprises several inlet ports.

14. The system of claim 12, further comprising an auxiliary delivery lumen between said first and second lumens and coaxially arranged with respect to said first lumen, said auxiliary delivery lumen having a secondary exit port positioned between said exit port and said inlet port.

15. The system of claim 14, wherein said secondary exit port comprises several secondary exit ports.

16. The system of claim 14, further comprising a second occlusion element positioned between said secondary exit port and said inlet port.

17. The system of claim 1, wherein said second lumen is an auxiliary delivery lumen and said second port is a secondary exit port, said system further comprising a supply lumen positioned coaxially with respect to said auxiliary delivery lumen, said supply lumen having an inlet port.

18. The system of claim 17, wherein said secondary exit port comprises several secondary exit ports.

19. The system of claim 17, wherein said inlet port comprises several inlet ports.

20. The system of claim 17, further comprising a second occlusion element positioned between said secondary exit port and said inlet port.

21. The system of claim 1, further comprising an anchoring element at said distal end of said first lumen.

22. The system of claim 21, wherein said anchoring element is a balloon.

23. The system of claim 21, wherein said anchoring element is a bent distal end.

24. The system of claim 1, wherein said control unit includes a thermal adjustor.

25. The system of claim 1, wherein said control unit includes a pumping mechanism.

26. The system of claim 1, further comprising a physiological sensor positioned at said exit port.

27. The system of claim 1, further comprising a pressure lumen and a physiological sensor at a proximal end of said pressure lumen.

28. The system of claim 26, wherein said physiological sensor is in communication with said control unit, said control unit configured to calculate an output based on data received from said physiological sensor.

29. The system of claim 28, wherein said output is presented as a display to a user.

30. The system of claim 28, wherein said output is used to automatically change a parameter provided by said control unit.

31. The system of claim 27, wherein said physiological sensor is in communication with said control unit, said control unit configured to calculate an output based on data received from said physiological sensor.

32. The system of claim 31, wherein said output is presented as a display to a user.

33. The system of claim 31, wherein said output is used to automatically change a parameter provided by said control unit.

34. A device for providing selective thermal therapy, the device comprising:

a supply lumen for delivering normothermal blood to a location outside of the body;

a delivery lumen for supplying thermally treated blood to a target site in the body, wherein said supply lumen is positioned around a portion of said delivery lumen and wherein said thermally treated blood is said normothermal blood after a thermal adjustment; and

an occlusion element positioned on said delivery lumen in a location which is proximal to a distal end of said delivery lumen and distal to a distal end of said supply lumen.

35. The device of claim 34, wherein said location outside of the body is a control unit, and wherein said control unit is configured for providing said thermal adjustment of said normothermal blood.

36. The device of claim 35, wherein said control unit further includes a pumping mechanism for pumping said adjusted normothermal blood into said delivery lumen.

37. The device of claim 34, wherein said supply lumen comprises at least one inlet port for receiving said normothermal blood, said inlet port positioned proximal to said occlusion element.

38. The device of claim 34, wherein said delivery lumen comprises at least one exit port for delivering said thermally treated blood to said target site, said exit port positioned distal to said occlusion element.

39. The device of claim 34, wherein said occlusion element is a balloon.

40. The device of claim 34 wherein said occlusion element has an atraumatic surface.

41. The device of claim 34, wherein said occlusion element includes a hydrophilic coating.

42. The device of claim 34, wherein said occlusion element includes a drug coating.

43. The device of claim 34, wherein said occlusion element is a mechanically expandable device.

44. The device of claim 34, wherein said occlusion element is a spring loaded device.

45. The device of claim 34, wherein said occlusion element includes a shape memory alloy.

46. The device of claim 38, further comprising a second occlusion element distal to said exit port.

47. The device of claim 34, further comprising an auxiliary delivery lumen between said supply and delivery lumens and coaxially arranged with respect to said delivery lumen.

48. The device of claim 47, wherein said auxiliary delivery lumen comprises a secondary exit port.

49. The device of claim 48, wherein said secondary exit port comprises several secondary exit ports.

50. The device of claim 34, further comprising an anchoring element at said distal end of said first lumen.

51. The device of claim 50, wherein said anchoring element is a balloon.

52. The device of claim 50, wherein said anchoring element is a bent distal end.

53. The device of claim 35, further comprising a physiological sensor positioned at a distal end of said device.

54. The device of claim 35, further comprising a pressure lumen and a physiological sensor at a proximal end of said pressure lumen.

55. The device of claim 53 wherein said physiological sensor is in communication with said control unit, said control unit configured to calculate an output based on data received from said physiological sensor.

56. The device of claim 55, wherein said output is presented as a display to a user.

57. The device of claim 55, wherein said output is used to automatically change a parameter provided by said control unit.

58. The device of claim 54 wherein said physiological sensor is in communication with said control unit, said control unit configured to calculate an output based on data received from said physiological sensor.

59. The device of claim 58, wherein said output is presented as a display to a user.

60. The device of claim 58, wherein said output is used to automatically change a parameter provided by said control unit.

61. A device for providing selective thermal therapy, the device comprising:

a first lumen having a distal end and a proximal end;

an exit port located on said first lumen;

a first occlusion element positioned on said first lumen, distal to said exit port;

a second lumen coaxial to said first lumen, said second lumen having a proximal end and a distal end;

a second occlusion element positioned on said second lumen; and

a second port positioned on said second lumen, said second port proximal to said second occlusion element.

62. The device of claim 61, wherein said first lumen is a delivery lumen for delivering thermally treated blood to a target site in the body.

63. The device of claim 61, wherein at least one of said first and second occlusion elements has an atraumatic surface.

64. The device of claim 61, wherein at least one of said first and second occlusion elements is a balloon.

65. The device of claim 61, wherein at least one of said occlusion elements includes a hydrophilic coating.

66. The device of claim 61, wherein at least one of said occlusion elements includes a drug coating.

67. The device of claim 61, wherein at least one of said first and second occlusion elements is a mechanically expandable device.

68. The device of claim 61, wherein at least one of said occlusion elements is a spring loaded device.

69. The device of claim 61, wherein at least one of said occlusion elements includes a shape memory alloy.

70. The device of claim 61, wherein said second lumen is a supply lumen for providing normothermal blood to a control unit and said second port is an inlet port.

71. The device of claim 70, wherein said inlet port comprises several inlet ports.

72. The device of claim 70, further comprising an auxiliary delivery lumen between said first and second lumens and coaxially arranged with respect to said first lumen, said auxiliary delivery lumen having a secondary exit port positioned between said exit port and said inlet port.

73. The device of claim 72, wherein said secondary exit port comprises several secondary exit ports.

74. The device of claim 61, wherein said second lumen is an auxiliary delivery lumen and said second port is a secondary exit port, said system further comprising a supply lumen positioned coaxially with respect to said auxiliary delivery lumen, said supply lumen having an inlet port.

75. The device of claim 74, wherein said secondary exit port comprises several secondary exit ports.

76. The device of claim 74, wherein said inlet port comprises several inlet ports.

77. A method for selectively cooling or heating a part of a body, the method comprising:

providing a device for insertion into a vessel, the device comprising a first lumen having an exit port, a second lumen having a second port, said second lumen positioned coaxial to said first lumen, and an occlusion element positioned between said exit port and said second port;

inserting said device into a vessel;

expanding said occlusion element so as to separate between a first area in fluid communication with said exit port and a second area in fluid communication with said second port;

withdrawing normothermic blood from said second area via said second port and through said second lumen;

delivering said normothermic blood to a control unit;

thermally treating said normothermic blood in said control unit to obtain thermally treated blood; and

delivering said thermally treated blood to said first area via said first lumen and said exit port.

78. The method of claim 77, wherein said thermally treating comprises cooling.

79. The method of claim 77, wherein said thermally treating comprises heating.

80. The method of claim 77, wherein said delivering said thermally treated blood comprises pumping said thermally treated blood.

81. The method of claim 77, further comprising delivering a second thermally treated blood to a location in the body, said second thermally treated blood having a different temperature than said thermally treated blood.

82. The method of claim 77, further comprising monitoring a physiological parameter;

and adjusting said thermally treating based on said monitored parameter.

83. A method for providing insulated thermally treated blood to a location in the body, the method comprising:

providing a delivery catheter; and

providing an insulating layer around said delivery catheter, said insulating layer being a conduit for insulating blood, said insulating blood being of a different temperature than said thermally treated blood.

84. The method of claim 83, wherein said insulating layer is a supply lumen, said supply lumen being a conduit for normothermal blood.

85. The method of claim 83, wherein said insulating layer is an auxiliary delivery lumen, said auxiliary delivery lumen being a conduit for supplemental thermally treated blood.