Methods and systems for reducing substance-induced renal damage

• US 6,685,733 B1
• Filed: 04/10/2002
• Issued: 02/03/2004
• Est. Priority Date: 04/10/2002
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Radiant Medical, Inc. (Asahi Kasei Corporation)
• Inventors: Dae, Michael W., Hopper, Phillip
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US10/120,167
• Time in Patent Office: 664 Days
• Field of Search: 607/96, 607/104-106, 607/113
• US Class Current: 607/105
• 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

Abstract

Methods for reducing kidney damage induced by radiographic contrast medium or another nephrotoxic drug or substance administered to or generated by a patient include reducing the temperature of the patient by positioning an endovascular heat exchange device in a blood vessel of the patient and adjusting the temperature of the device to cause a reduction in the patient'"'"'s temperature. The patient'"'"'s temperature may be reduced prior to, during, and/or after, the administration of the contrast medium. The methods may also include administering an anti-shivering mechanism to the patient to reduce shivering caused by the reduction in the patient'"'"'s temperature. The methods may also include disrupting the laminarity of blood flow around the device to enhance the temperature exchange between the device and the blood flowing around the device. The endovascular heat exchange device may be an endovascular heat exchange catheter. The device may be a component of a system, which includes a temperature controller in communication with the endovascular heat exchange device to reduce the temperature of the patient to reduce the temperature of the patient'"'"'s kidneys.

Claims

1. A method of preventing or reducing the severity of renal damage due to a blood-borne substance that is toxic to the kidneys of a human or veterinary patient, the method comprising the steps of:

positioning an endovascular heat exchange device in a blood vessel of the patient; and

using the endovascular heat exchange device to cool at least the patient'"'"'s kidneys to a temperature at which the substance-induced renal damage is prevented or reduced in severity.

2. A method according to claim 1 wherein the endovascular heat exchange device is a catheter having a heat exchange region.

3. A method according to claim 1 wherein the endovascular heat exchange device is a catheter having a heat exchange region, the heat exchange region comprising at least one heat exchange balloon through which heat exchange fluid is circulated.

4. The method of claim 3, further comprising a step of inflating the heat exchange balloon by circulating heat exchange fluid therethrough.

5. A method according to claim 1 wherein the endovascular heat exchange device comprises a heat exchange region that is metallic.

6. A method according to claim 1 further comprising a step of disrupting laminarity of blood flow around the endovascular heat exchange device.

7. A method according to claim 1 wherein the endovascular heat exchange device is positioned proximate the patient'"'"'s heart to cause a reduction in the temperature of the blood flowing through the patient'"'"'s heart.

8. A method according to claim 1 wherein the step of reducing the patient'"'"'s temperature is performed prior to administering the substance to the patient.

9. A method according to claim 1 further comprising a step of maintaining the reduced temperature of the patient during the administration of the substance to the patient.

10. A method according to claim 1 further comprising a step of maintaining the reduced temperature after the administration of the substance to the patient.

11. A method according to claim 1 wherein the patient'"'"'s body temperature is reduced below 37 degrees Celsius.

12. A method according to claim 1 wherein the patient'"'"'s body temperature is reduced to a temperature between 32 degrees Celsius and 37 degrees Celsius.

13. A method according to claim 1 further comprising a step of administering an anti-shivering treatment to the patient to reduce shivering caused by reducing the temperature of the endovascular heat exchange device.

14. The method of claim 13, wherein the anti-shivering treatment is a blanket.

15. The method of claim 13, wherein the anti-shivering treatment is an anti-shivering agent.

16. A method according to claim 1 wherein the kidney damage is the result of the administration of radiographic contrast medium.

17. A method according to claim 1 wherein the kidney damage is contrast medium-induced nephropathy.

18. A method according to claim 1 wherein the kidney damage is due to the ingestion, absorption, formation or exposure to a nephrotoxic drug or substance.

19. A method according to claim 18 wherein the nephrotoxic drug or substance is selected from the group consisting of non-steroidal antiinflamatory drugs (NSAID'"'"'s), amphotericin, cisplatin, methotrexate, acyclovir, gentamicin, acetylcholinesterase inhibitors, other nephrotoxic drugs, products of tumor lysis, products of sepsis, products of infection, and products of rhabdomyolysis.

20. A method according to claim 19 wherein the patient has received an overdose of a nephrotoxic drug or substance and wherein the method further comprises the step of:

making at least a preliminary diagnosis of overdose with a nephrotoxic substance prior to using the endovascular heat exchange device to cool at least the patient'"'"'s kidneys.

21. The method of claim 20, comprising reducing the temperature of the patient'"'"'s kidneys to a temperature that reduces ischemic injury of the kidney.

22. The method of claim 20, comprising reducing the patient'"'"'s temperature to a temperature between 32 degrees Celsius and 37 degrees Celsius.

23. The method of claim 20, further comprising a step of administering an anti-shivering treatment to the patient.

24. The method of claim 23, wherein the anti-shivering treatment is an anti-shivering agent selected from the group consisting of:

dopamine receptor blockers;

dopamine receptor agonists;

kappa opioid receptor agonists;

opioid agonist-antagonist analgesics;

serotonin 5HT1a receptor agonists; and

their pharmaceutically acceptable salts.

25. A method according to claim 1 wherein a kidney or a portion of the body including a kidney is cooled and wherein the method further comprises:

positioning a first endovascular heat exchange device in a first blood vessel of the patient through which blood flows to at least one of the patient'"'"'s kidneys;

positioning a second endovascular heat exchange device in a second blood vessel of the patient through which blood flows from at least one of the patient'"'"'s kidneys;

using the first endovascular heat exchange device to cool blood flowing to at least one of the patient'"'"'s kidneys; and

,

using the second endovascular heat exchange device to warm blood flowing from at least one of the patient'"'"'s kidneys.

26. A method according to claim 1 wherein a kidney or a portion of the body including a kidney is cooled and wherein the method further comprises:

positioning a first endovascular heat exchange device in the aorta upstream of the location at which a renal artery branches from the aorta;

positioning a second endovascular heat exchange device in the aorta downstream of said location at which a renal artery branches from the aorta;

using the first endovascular heat exchange device to cool blood flowing through the aorta, a portion of which flows into the renal artery; and

,

using the second endovascular heat exchange device to warm the remaining blood flowing through the aorta after the portion has flowed into the renal artery.

27. A method according to claim 1 further comprising a step of monitoring the temperature of the patient.

28. A method according to claim 1 further comprising steps of:

monitoring the temperature of the patient; and

adjusting the temperature of the heat exchange catheter based on the temperature so monitored.

29. A method for preventing or reducing the severity of kidney damage in a human or veterinary patient due to the administration, ingestion, absorption or production of, or exposure to, a nephrotoxic substance, said method comprising the steps of:

providing a heat exchange catheter that has a heat exchanger which is positionable within a blood vessel of the patient and a controller that controls the temperature of the heat exchanger;

positioning the heat exchanger in a blood vessel of the patient without entirely preventing the flow of blood around the heat exchanger; and

controlling the temperature of the heat exchanger to reduce the temperature of the patient'"'"'s blood and to cool the patient'"'"'s kidneys, thereby preventing or reducing the severity of kidney damage.

30. The method of claim 29, wherein the patient'"'"'s kidneys are cooled prior to the administration of the substance to the patient.

31. The method of claim 29, wherein the patient'"'"'s kidneys are cooled during the administration of the substance to the patient.

32. The method of claim 29, wherein the patient'"'"'s kidneys are cooled after the administration of the substance to the patient.

33. The method of claim 29, further comprising the step of maintaining the reduction in temperature during the administration of the substance to the patient.

34. The method of claim 29, wherein the heat exchange catheter comprises at least one balloon containing a heat exchange fluid.

35. The method of claim 34, wherein the heat exchange catheter is positioned in the patients inferior or superior vena cava.

36. The method of claim 34, wherein the at least one balloon is disposed at the distal end of the heat exchange catheter.

37. The method of claim 29, further comprising a step of disrupting the laminar flow of blood around the heat exchange catheter.

38. The method of claim 37, wherein the laminar flow of blood is disrupted by one or more fins provided on the heat exchange catheter.

39. The method of claim 29, wherein the heat exchange catheter is positioned in the patient'"'"'s venous system.

40. The method of claim 29, further comprising a step of monitoring the temperature of the patient.

41. The method of claim 29, further comprising steps of:

monitoring the temperature of the patient; and

adjusting the temperature of the heat exchange catheter based on the temperature so monitored.

42. A system for preventing or reducing the severity of renal damage due to a blood-borne substance that is toxic to the kidneys of a human or veterinary patient, said system comprising:

a heat exchange catheter insertable into a blood vessel of the patient; and

a temperature controller in communication with the heat exchange catheter to cause the heat exchange catheter to reduce the temperature of at least the a patient'"'"'s kidneys to a temperature at which the substance-induced renal damage is prevented or mitigated; and

an anti-shivering element comprising a quantity of an anti-shivering agent and apparatus for administering that anti-shivering agent to the patent.

43. The system of claim 42, wherein the heat exchange catheter comprises at least one balloon containing a heat exchange fluid flowing from the temperature controller.

44. The system of claim 42, wherein the at least one balloon is circumferentially disposed about the catheter to direct the heat exchange fluid in an opposite direction of blood flowing past the catheter.

45. The system of claim 42, wherein the temperature controller includes

temperature monitoring means for monitoring the patient'"'"'s temperature; and

temperature adjusting means for adjusting the temperature of the heat exchange catheter to maintain a constant reduced temperature of the patient'"'"'s kidneys.

46. The system of claim 45, wherein the temperature adjusting means adjusts the temperature in response to the temperature monitored by the temperature monitoring means.

47. The system of claim 42, wherein the heat exchange catheter comprises a flow disruption device to disrupt the laminarity of blood flow around the catheter.

48. The system of claim 42, wherein the temperature controller controls the temperature and flow of heat exchange fluid flowing through the heat exchange catheter.

49. The system of claim 42 wherein the anti-shivering agent is selected from the group consisting of:

dopamine receptor blockers;

dopamine receptor agonists;

kappa opioid receptor agonists;

opioid agonist-antagonist analgesics;

serotonin 5HT1a receptor agonists; and

their pharmaceutically acceptable salts.