Temperature regulating catheter and methods

• US 6,033,383 A
• Filed: 12/19/1996
• Issued: 03/07/2000
• Est. Priority Date: 12/19/1996
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Radiant Medical, Inc. (Asahi Kasei Corporation)
• Inventors: Ginsburg, Robert
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/769,931
• Time in Patent Office: 1,174 Days
• Field of Search: 604/49, 604/113, 604/114, 604/264, 604/280, 604/247, 607/96, 607/104-107
• US Class Current: 604/113
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61F 2007/0054 with a closed fluid circuit, e.g. hot water
• 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 2025/0078 for fluid inflow from the body into the catheter lumen
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2205/366 by liquid heat exchangers
• CPC Class Codes: A61M 2206/10 Flow characteristics
• CPC Class Codes: A61M 2230/50 Temperature
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

The invention provides methods and apparatus for regulating the temperature of a liquid medium while the liquid medium is within a patient. According to one exemplary method, a catheter is provided having a catheter body with a proximal end and a distal end. At least one lumen extends between the proximal end and distal end, and an internal temperature altering region is near the distal end. The catheter is introduced into a body structure until the temperature altering region is near a target area within the body structure. A liquid medium is introduced into the lumen so that the temperature of the liquid medium may be altered while passing through the temperature altering region.

Claims

1. A catheter for placement in a body structure within a patient, the catheter comprising:

a catheter body having a proximal end, a distal end, at least one lumen defined by a luminal wall extending between the proximal end and the distal end said luminal wall defining at least one orifice therethrough to permit a body fluid to flow therethrough from the body of the patient into said lumen; and

a temperature altering mechanism in thermal communication with said lumen which alters the temperature of the body fluid passing through the lumen.

2. A catheter as in claim 1, further comprising a proximal port at the proximal end of the catheter body which is in fluid communication with the lumen, whereby fluids introduced into the proximal port may pass through the lumen and have their temperature altered before exiting from the distal end.

3. A catheter as in claim 2, further comprising a one-way valve associated with each orifice wherein the valves prevent body fluids from entering the lumen through the at least one orifice when closed and wherein the valves are configured to close when introducing an injection fluid into the lumen from the proximal port.

4. A catheter as in claim 3, wherein the valves are configured to open when the pressure of the body fluids outside the catheter body is greater than the pressure within the lumen.

5. A catheter as in claim 4, wherein the valves comprise flaps attached to the luminal wall.

6. A catheter as in claim 1, wherein the temperature altering mechanism comprises a channel within the catheter body running parallel to at least a portion of the lumen through which a heat transfer fluid may be passed.

9. A catheter as in claim 1, wherein the temperature altering mechanism comprises a heater.

10. A catheter as in claim 1, wherein the temperature altering mechanism comprises a cooler.

11. A catheter as in claim 1, wherein the catheter body is defined by an outer surface and the temperature altering mechanism is disposed near a luminal wall section within the temperature altering region to heat or cool the luminal wall section without substantial heating or cooling of the outer surface of the catheter body.

12. A catheter as in claim 1, wherein the catheter body is flexible and has a length in the range from about 30 cm to about 130 cm and an outer diameter in the range from about 2 mm to about 6 mm.

13. A catheter as in claim 1 wherein the catheter body has a discrete temperature altering region for heat transfer formed along only a portion of the catheter body, and further wherein said temperature altering mechanism is contained within said temperature altering region.

14. A catheter as in claim 1 wherein said body structure is a blood vessel and said body fluid is blood.

7. A catheter as in 6, wherein the channel includes a first path which is adjacent the luminal surface and a second path which is adjacent an outer surface of the catheter body.

8. A catheter as in claim 7, further comprising a heat transfer fluid port in communication with the first path and an exit port in communication with the second path.

15. A heat exchange catheter comprising:

a catheter body defined by a proximal end, a distal end, and an internal lumen defined by a luminal wall extending along at least a portion of the catheter body for passage of fluid, said catheter body is formed with at least one orifice in communication with the internal lumen to permit a body fluid to flow therethrough from the body of the patient into the internal lumen; and

a heat transfer region defined along only a discrete portion of the catheter body distal to the proximal end of the catheter body having a temperature altering mechanism adjacent to the luminal wall of the catheter body for exchanging heat with the fluid within the lumen.

16. The heat exchange catheter as recited in claim 15 wherein the temperature altering mechanism includes a first fluid path and a second fluid path for circulating a heat transfer fluid to heat or cool fluid passing through the internal lumen of the catheter body.

17. The heat exchange catheter as recited in claim 15 wherein the catheter body is formed with a proximal port towards the proximal end of the catheter body in fluid communication with the internal lumen of the catheter body.

18. A method for regulating the temperature of a liquid medium while the liquid medium is within a patient, the method comprising:

providing a catheter comprising a catheter body having a proximal end, a distal end, at least one lumen defined by a luminal wall extending between the proximal end and the distal end, and an internal temperature altering region disposed along the luminal wall of the catheter body for heat transfer defined by only a portion of the catheter body;

introducing the catheter into a body structure until the distal end of the catheter body is near a target area within the body structure;

introducing a liquid medium into the lumen; and

altering the temperature of the liquid medium while passing through the temperature altering region so that the temperature of the liquid medium is altered when delivered to the target area.

19. A method as in claim 18, wherein the catheter body is formed with at least one orifice proximal of the temperature altering region and the liquid medium is introduced into the lumen through the at least one orifice while the at least one orifice is within the body structure.

20. A method as in claim 19, further comprising introducing an injection fluid into the lumen from the proximal end, and introducing a body fluid into the lumen through the at least one orifice while the at least one orifice is within the body structure.

21. A method as in claim 20, further comprising preventing the body fluid from entering into the lumen through the at least one orifice when the injection fluid is introduced into the lumen from the proximal end.

22. A method as in claim 21, further comprising preventing the injection fluid from exiting the catheter body through the at least one orifice, wherein the injection fluid passes through the temperature altering region and exits the catheter body from the distal end.

23. A method as in claim 18, wherein the body structure comprises a vessel.

24. A method as in claim 23, wherein the vessel is located within the brain or other organ.

25. A method as in claim 18, wherein the temperature of the liquid medium is altered without substantial alteration of the temperature of an outside surface of the catheter body.

26. A method as in claim 18, wherein the temperature of the liquid medium is heated by a temperature in the range from about 36°

C. to about 42°

C.

27. A method as in claim 18, wherein the temperature of the liquid medium is cooled by a temperature in the range from about 36°

C. to about 30°

C.

28. A method as in claim 18, wherein the liquid medium comprises a body fluid which is selected from the group of liquid mediums comprising solutes, drugs, body fluids, and blood or blood substitutes.

29. A method as in claim 18, wherein the liquid medium is introduced into the lumen at the proximal end.

30. A method as in claim 18, wherein the catheter body includes a channel and the temperature altering step further comprises passing a heat transfer fluid through the channel.

31. A method for altering the temperature of a body fluid, said method comprising the steps of:

providing a catheter having a lumen, said lumen having at least one orifice to permit a body fluid to flow through said orifice into said lumen, said catheter further having a heat altering mechanism in thermal communication with fluid contained within said lumen;

placing said catheter in a body structure containing body fluid;

permitting said body fluid to enter said lumen; and

altering the temperature of said body fluid by said heat altering mechanism.

32. A method as recited in claim 31 wherein said body structure is a blood vessel and said body fluid is blood.