Systems and methods for selective thermal treatment

• US 20060167399A1
• Filed: 01/25/2006
• 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 7,704,220 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 or heating of a target site in the human body include a catheter having a supply elongated element and a delivery elongated element, with inlet and exit ports. Blood is withdrawn from the supply elongated element and cooled or heated in a control unit. The treated blood is sent to the targeted area via delivery elongated element. The supply elongated element can act as an insulator for the treated blood in the delivery elongated element.

Claims

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

a first elongated element having a first lumen therethrough, said first elongated element having a distal end and a proximal end;

an exit port located at said distal end of said first elongated element;

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

a second elongated element having a second lumen therethrough, said second elongated element coaxial to said first elongated element and moveable with respect to said first elongated element, said second elongated element having a proximal end and a distal end, said distal end of said second elongated element proximal to said distal end of said first elongated element;

a second port located at said distal end of said second elongated element, said second port proximal to said occlusion element; and

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

2. The system of claim 1, wherein said second port comprises multiple ports.

3. The system of claim 1, wherein an outer diameter of said first elongated element is at least 0.1 mm smaller than an inner diameter of said second elongated element, thus creating a space between said first elongated element and said second elongated element, wherein said space defines said second port.

4. 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.

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

6. The system of claim 1, wherein said occlusion element is an inflatable balloon.

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 at least some of said first lumen, said second lumen and said occlusion element are coated with an anti-thrombotic substance.

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

11. The system of claim 10, further comprising an auxiliary delivery elongated element between said first and second elongated elements and coaxially arranged with respect to said first elongated element, said auxiliary delivery elongated element having a secondary exit port positioned between said exit port and said inlet port.

12. The system of claim 11, wherein said secondary exit port comprises multiple secondary exit ports.

13. The system of claim 11, further comprising a second occlusion element positioned between said secondary exit port and said inlet port.

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

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

16. The system of claim 14, wherein said inlet port comprises several inlet ports.

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

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

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

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

21. The system of claim 20, 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.

22. The system of claim 1, further comprising a pressure lumen and a physiological sensor at or in communication with a proximal end of said pressure lumen.

23. The system of claim 1, further comprising an inflatable balloon at said distal end of said first elongated member, said inflatable balloon configured to seal said first lumen upon inflation of said inflatable balloon.

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

a supply elongated element having a supply lumen therethrough for delivering normothermal blood to a location outside of the body, said supply elongated element having at least one inlet port at a distal end thereof for receiving said normothermal blood;

a delivery elongated element having a delivery lumen therethrough for supplying thermally treated blood to a target site in the body, wherein said supply elongated element is positioned coaxial to said delivery elongated element and wherein said thermally treated blood is said normothermal blood after a thermal adjustment, said delivery elongated element having at least one exit port at a distal end thereof for providing said thermally treated blood to said target site; and

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

25. The system of claim 24, wherein at least some of said supply lumen, said delivery lumen and said occlusion element are coated with an anti-thrombotic substance.

26. The device of claim 24, 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.

27. The device of claim 24, wherein an outer diameter of said delivery elongated element is at least 0.1 mm smaller than an inner diameter of said supply elongated element, thus creating a space between said delivery elongated element and said supply elongated element, wherein said space defines said inlet port.

28. The device of claim 24, wherein said occlusion element is an inflatable balloon.

29. The device of claim 24, wherein said occlusion element includes a hydrophilic coating.

30. The device of claim 24, wherein said occlusion element includes a drug coating.

31. The device of claim 24, further comprising a second occlusion element distal to said exit port.

32. The device of claim 24, further comprising an auxiliary delivery elongated element between said supply and delivery elongated elements and coaxially arranged with respect to said delivery elongated element.

33. The device of claim 32, wherein said auxiliary delivery elongated element includes a secondary exit port.

34. The device of claim 24, further comprising a physiological sensor positioned at a distal end of said device.

35. The device of claim 34 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.

36. The device of claim 24, further comprising a pressure lumen and a physiological sensor at or in communication with a proximal end of said pressure lumen.

37. The device of claim 36, further comprising an inflatable balloon at said distal end of said delivery elongated member, said inflatable balloon configured to seal said delivery lumen upon inflation of said inflatable balloon.

38. 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 elongated element having a first lumen and an exit port, a second elongated element having a second lumen and a second port, said second elongated element positioned coaxial to said first elongated element, 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.

39. The method of claim 38, wherein said thermally treating comprises cooling.

40. The method of claim 38, wherein said thermally treating comprises heating.

41. The method of claim 38, wherein said delivering said thermally treated blood comprises pumping said thermally treated blood.

42. The method of claim 38, 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.

43. The method of claim 38, further comprising monitoring a physiological parameter;

and adjusting said thermally treating based on said monitored parameter.

44. A method for insulating thermally treated blood for delivery to a location in the body, the method comprising:

providing a delivery catheter having a delivery lumen and a supply lumen which is coaxial to said delivery lumen;

inserting said delivery catheter into the arterial system;

withdrawing normothermic blood from the arterial system via said supply lumen;

simultaneously providing thermally treated blood via said delivery lumen to the arterial system, said simultaneous providing being in a location which is distal to a location of said withdrawing,

wherein said withdrawing is done coaxial to said providing thermally treated blood, thus providing a layer of insulation to said thermally treated blood.

45. A method for positioning of a thermal treatment catheter in a target artery, the method comprising:

positioning a guidewire in a proximal artery, said proximal artery being proximal to the target artery;

introducing a search catheter over said guidewire;

partially withdrawing said guidewire;

locating the target artery with said search catheter;

advancing said guidewire through said search catheter and into the target artery;

removing the search catheter; and

advancing a distal end of said thermal treatment catheter over the guidewire into the target artery.

46. The method of claim 45, wherein said target artery is a carotid artery, and wherein said advancing comprises advancing into the carotid artery.

47. The method of claim 45, wherein said target artery is a renal artery, and wherein said advancing comprises advancing into the renal artery.

48. The method of claim 45, wherein said target artery is a coronary artery, and wherein said advancing comprises advancing into the coronary artery.

49. The method of claim 45, further comprising introducing a supply elongated element over said guidewire, and wherein said introducing said search catheter is done through a lumen of said supply elongated element.

50. The method of claim 45, wherein said positioning comprises positioning in an aortic arch.

51. The method of claim 45, wherein said introducing a search catheter includes introducing a search catheter through a delivery elongated element of said thermal treatment catheter.

52. The method of claim 45, wherein said introducing a search catheter includes introducing a delivery elongated element of said thermal treatment catheter, wherein said delivery elongated element has a bent distal end for locating a vessel.

53. The method of claim 46, wherein said advancing said guidewire through said search catheter and into the carotid artery includes advancing said guidewire into an external carotid artery, and advancing a distal end of said treatment catheter into the carotid artery includes advancing said distal end into the external carotid artery.

54. The method of claim 46, wherein said advancing said guidewire through said search catheter and into the carotid artery includes advancing said guidewire into an internal carotid artery, and advancing a distal end of said treatment catheter into the carotid artery includes advancing said distal end into the internal carotid artery.