Targeted cooling of tissue within a body

• US 7,326,195 B2
• Filed: 11/18/2003
• Issued: 02/05/2008
• Est. Priority Date: 11/18/2003
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Harrison, Kent, Willard, Martin
• Primary Examiner(s): Lucchesi; Nicholas
• Assistant Examiner(s): Stigell; Theodore J
• Application Number:
  US10/715,636
• Publication Number:
  US 20050107741A1
• Time in Patent Office: 1,540 Days
• Field of Search: 604/113, 604/6.401, 604 613- 616, 604/96.01, 60410201-10203, 604/264, 604/500, 604506-509, 607/102
• US Class Current: 604/508
• 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: A61F 7/123 using a flexible balloon containing the thermal element

Abstract

Devices and methods to cool a target tissue region inside the body are described. Fluid cooled below normal body temperature and blood at a normal body temperature are provided to the tissue region in proportions to cool the tissue region. A system for controlling the temperature of the target tissue region is disclosed. The system includes a catheter and a control system that controls the amount of cool fluid and blood provided to the tissue region. A catheter for providing cool fluid to the tissue region is also provided. The catheter includes a temperature sensor that extends to a location distal to the distal end of the catheter to sense the temperature of the tissue region.

Claims

1. A method of cooling a target tissue region inside a human body, the method comprising:

providing non-oxygenated fluid cooled below normal human body temperature of about 37 degrees Celsius and oxygenated blood at a normal human body temperature of about 37 degrees Celsius to the tissue region in proportions to cool the tissue region and maintain, for an extended period of time greater than two minutes, the temperature of the tissue region within a target temperature range that is one to nine degrees Celsius below the normal body temperature, wherein the oxygenated blood is provided so that any continuous period of time during which the tissue region is deprived of oxygenated blood while the non-oxygenated fluid is being provided continues for less than two minutes, and further wherein the providing of the blood at the normal body temperature to the tissue region is performed using a catheter that occludes a vessel upstream from the tissue region and permits a selected amount of blood to flow through a lumen in the catheter and to the tissue region.

2. The method of claim 1 wherein the cooled fluid and the blood at normal body temperature are provided to the tissue region simultaneously.

3. The method of claim 1 wherein the catheter also performs the providing of cool fluid to the tissue region.

4. The method of claim 1 wherein a catheter positioned in a vessel in fluid communication with the tissue region provides the fluid to the tissue region through a lumen that extends longitudinally through the catheter, the lumen having a diameter of at least twenty thousandths of an inch.

5. The method of claim 1 wherein the temperature of the tissue region is maintained within the target temperature range that is below normal body temperature for a time period beyond the normal length of time a tissue region is deprived of oxygenated blood during a head procedure.

6. The method of claim 5 wherein the normal length of time a tissue region is deprived of oxygenated blood during a heart procedure is about two minutes.

7. The method of claim 1 wherein the temperature of the tissue region is maintained within the target temperature range for at least about two minutes.

8. The method of claim 1 wherein the providing of fluid and blood to cool the target tissue region is performed during a procedure to open a lesion in a vessel.

9. The method of claim 1 wherein a control system controls the providing of fluid and blood to the tissue region.

10. A method of cooling a target tissue region inside a human body, the method comprising:

occluding a human body vessel to prevent normal blood flow to the tissue region;

providing, while the body vessel is occluded, cooled fluid to the tissue region to cool the tissue region below normal body temperature of about 37 degrees Celsius;

recommencing normal blood flow to the tissue region by removing the occlusion in the body vessel;

preventing normal blood flow to the tissue region again by occluding the body vessel before the temperature of the tissue region returns to normal body temperature; and

providing, while the body vessel is occluded, cooled fluid to the tissue region again to maintain the temperature of the tissue region below the normal body temperature of about 37 degrees Celsius.

11. The method of claim 10 wherein the body vessel is occluded to prevent normal blood flow to the tissue region by inflating a balloon positioned in the vessel.

12. The method of claim 10 wherein a catheter positioned in a vessel at a location upstream from the tissue region provides the fluid to the tissue region through a lumen extending longitudinally through the catheter, the lumen having a diameter of at least twenty thousandths of an inch.

13. The method of claim 10 wherein a control system controls the occluding of the body vessel and the providing of cooled fluid to the tissue region to maintain the temperature of the tissue region below normal body temperature.

14. A method of cooling a target tissue region inside a human body, the method comprising:

restricting normal blood flow to the tissue region so that only a desired amount of blood is provided to the tissue region; and

providing cool fluid to mix with the blood provided to the tissue region so as to cool the tissue region below normal body temperature of about 37 degrees Celsius and to maintain, for an extended period of time greater than two minutes, the temperature of the tissue region within a target temperature range that is one to nine degrees Celsius below the normal body temperature of about 37 degrees Celsius, further wherein the providing of the blood at normal body temperature to the tissue region is performed using a catheter that occludes a vessel upstream from the tissue region and permits a selected amount of blood to flow through a lumen in the catheter and to the tissue region.

15. The method of claim 14 wherein the temperature of the tissue region is maintained within the target temperature range that is below the normal body temperature for a time period beyond the normal length of time a tissue region is deprived of oxygenated blood during a heart procedure.

16. The method of claim 15 wherein the normal length of time a tissue region is deprived of oxygenated blood during a heart procedure is about two minutes.

17. The method of claim 14 wherein the temperature of the tissue region is maintained within the target temperature range for at least about two minutes.

18. The method of claim 14 wherein a catheter positioned in a vessel in fluid communication with the tissue region provides the fluid to the tissue region through a lumen that extends longitudinally through the catheter, the lumen having a diameter of at least twenty thousandths of an inch.

19. The method of claim 14 wherein a control system controls the providing of fluid to the tissue region to maintain the temperature of the tissue region below normal body temperature.

20. A method of cooling a target tissue region inside a human body, the method comprising:

providing non-oxygenated fluid cooled below normal human body temperature of about 37 degrees Celsius and oxygenated blood at the normal human body temperature of about 37 degrees Celsius to the tissue region in proportions to cool the tissue region and maintain, for an extended period of time greater than two minutes, the temperature of the tissue region within a target temperature range that is one to nine degrees Celsius below the normal human body temperature of about 37 degrees Celsius, wherein the oxygenated blood is provided so that any continuous period of time during which the tissue region is deprived of oxygenated blood while the non-oxygenated fluid is being provided continues for less than two minutes, and further wherein the providing of the blood at the normal body temperature to the tissue region is performed by occluding a vessel upstream from the tissue region to restrict normal blood flow and then removing the occlusion to permit normal blood flow.

21. The method of claim 20 wherein the cooled fluid and the blood at normal body temperature are provided to the tissue region simultaneously.

22. The method of claim 20 wherein the catheter also performs the providing of cool fluid to the tissue region.

23. The method of claim 20 wherein a catheter positioned in a vessel in fluid communication with the tissue region provides the fluid to the tissue region through a lumen that extends longitudinally through the catheter, the lumen having a diameter of at least twenty thousandths of an inch.

24. The method of claim 20 wherein the temperature of the tissue region is maintained within the target temperature range that is below normal body temperature for a time period beyond the normal length of time a tissue region is deprived of oxygenated blood during a heart procedure.

25. The method of claim 24 wherein the normal length of time a tissue region is deprived of oxygenated blood during a heart procedure is about two minutes.

26. The method of claim 20 wherein the temperature of the tissue region is maintained within the target temperature range for at least about two minutes.

27. The method of claim 20 wherein the providing of fluid and blood to cool the target tissue region is performed during a procedure to open a lesion in a vessel.

28. The method of claim 20 wherein a control system controls the providing of fluid and blood to the tissue region.