Brain resuscitation and organ preservation device and method for performing the same

• US 5,584,804 A
• Filed: 02/03/1995
• Issued: 12/17/1996
• Est. Priority Date: 10/10/1990
• Status: Expired due to Term

• Current Assignee: Organ Recovery Systems, Inc. (Shanghai Genext Medical Technology Co., Ltd.)
• Original Assignee: Life Resuscitation Technologies Incorporated
• Inventors: Klatz, Ronald M., Goldman, Robert M.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/383,240
• Time in Patent Office: 683 Days
• Field of Search: 604/23-28, 604/49, 604/52, 604/4-6, 607/105-107, 128/898
• US Class Current: 604/24
• CPC Class Codes: A01N 1/02 Preservation of living parts
• CPC Class Codes: A01N 1/0226 Physiologically active agents, i.e. substances affecting physiological processes of cells and tissue to be preserved, e.g. anti-oxidants or nutrients
• CPC Class Codes: A01N 1/0247 for perfusion, i.e. for circulating fluid through organs, blood vessels or other living parts
• CPC Class Codes: A61B 16/00 Devices specially adapted for vivisection or autopsy similar devices for medical purposes, see the relevant groups for such devices ; autopsy tables A61G13/0027
• CPC Class Codes: A61B 2017/00969 used for transplantation
• CPC Class Codes: A61H 31/00 Artificial respiration or heart stimulation, e.g. heart massage artificial respiration by treatment with gas or air, e.g. mouth-to-mouth respiration A61M16/00; applying electric currents by contact electrodes for stimulation, e.g. heart pace-makers A61N1/36 ; teaching or training models, demonstration models for medical purposes G09B23/288
• CPC Class Codes: A61M 16/00 Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes stimulating the respiratory movement by mechanical, pneumatic or electrical means, iron lungs combined with gas breathing means A61H31/00
• CPC Class Codes: A61M 16/0054 Liquid ventilation
• CPC Class Codes: A61M 16/022 Control means therefor
• CPC Class Codes: A61M 2202/0476 Oxygenated solutions
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/268 the displacement member being flexible, e.g. membranes, diaphragms or bladders
• CPC Class Codes: A61M 60/31 for enhancement of in vivo organ perfusion, e.g. retroperfusion
• CPC Class Codes: A61M 60/38 Blood oxygenation
• CPC Class Codes: A61M 60/427 the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/538 Regulation using real-time blood pump operational parameter data, e.g. motor current
• CPC Class Codes: A61M 60/546 of blood flow, e.g. by adapting rotor speed
• CPC Class Codes: Y10S 128/13 Infusion monitoring

Abstract

The invention discloses methods for preserving organs in brain-dead humans or cadavers which allows additional time for the organs to remain viable such that they may be harvested for subsequent transplantation. This invention also discloses methods for preserving and/or resuscitating organs in live (nonbrain-dead) patients, allowing for additional time to stabilize the patient'"'"'s condition. The methods include the steps of instrumentizing (e.g., catheterizing, cannulating, injecting, etc.) the vessels or tissues around the organ, or the organ itself sought to be preserved and/or resuscitated, the body cavity, or cavities of the body, and introducing a temperature-controlled solution to preserve and/or resuscitate the organ(s). The temperature-controlled organ preservation solution includes components such as oxygen carrying agents, antioxidants, tissue damage reversing and protecting agents, carrier vehicles, diluents, nutrients, and anti-coagulating agents. A device which performs this method is also disclosed. This device includes a fluid reservoir, an oxygen tank, a heat exchanger and removable catheter lines.

Claims

1. A method of treating tissues and/or organs in a live patient or cadaver comprising:

a) accessing a body cavity of the patient or cadaver; and

b) perfusing the body cavity of the patient or cadaver by;

1) lowering the temperature of the organs in the body cavity, by introducing cooled fluid into the accessed body cavity, said cooled fluid being at a temperature below body temperature;

2) inhibiting free radical damage in the organs by introducing a free radical scavenger into the accessed body cavity; and

3) oxygenating said organs by introducing an oxygen carrying agent into the accessed body cavity,

whereby the metabolic rates of said tissues and/or said organs are slowed and said tissues and/or said organs remain viable.

2. The method of claim 1, wherein said method further includes the step of introducing a tissue-protecting agent and a damage-reversing agent into the accessed body cavity.

3. The method of claim 1, wherein said oxygen carrying agent is selected from the group consisting of perfluorocarbons, hemoglobin based blood substitutes and non-hemoglobin based blood substitutes.

4. The method of claim 1, wherein said fluid is approximately 40 degrees F.

5. The method of claim 1, additionally comprising the step of externally compressing the body of said live patient or cadaver proximate the body cavity.

6. The method of claim 1, wherein said free radical scavenger is selected from the group consisting of antioxidants.

7. The method of claim 6, wherein said antioxidant is selected from the group consisting of Vitamin A, Vitamin B, Vitamin C, Vitamin E, Selenium, Cystine, Cysteine, BHT, BHA and Hydergine.

8. The method of claim 1, wherein accessing the body cavity of the patient or cadaver includes instrumentizing the body cavity by piercing the skin.

9. The method of claim 8, wherein said instrumentizing the body cavity includes cannulating the body cavity.

10. A method of treating tissues and/or organs in a live patient or cadaver comprising:

a) accessing a cavity of the body of the patient or cadaver; and

infusing the cavity of the body of the patient or cadaver by;

1) lowering the temperature of the organs in the body cavity, by introducing cooled fluid into the accessed cavity of the body, said cooled fluid being at a temperature below body temperature;

2) inhibiting free radical damage in the organs by introducing a free radical scavenger into the accessed cavity of the body; and

3) oxygenating said organs by introducing an oxygen carrying agent into the accessed cavity of the body,

whereby the metabolic rates of said tissues and/or said organs are slowed and said tissues and/or said organs remain viable.

11. The method of claim 10, wherein said cavity of the body is selected from the group consisting of the gastro-intestinal tract, the respiratory tract and the urinary tract.

12. The method of claim 10, wherein said method further includes the step of introducing a tissue-protecting agent and a damage-reversing agent into the accessed cavity of the body.

13. The method of claim 10, wherein said oxygen carrying agent is selected from the group consisting of perfluorocarbons, hemoglobin based blood substitutes and non-hemoglobin based blood substitutes.

14. The method of claim 10, wherein said fluid is approximately 40 degrees F.

15. The method of claim 10, additionally comprising the step of externally compressing the body of said live patient or cadaver proximate the cavity of the body.

16. The method of claim 10, wherein said free radical scavenger is selected from the group consisting of antioxidants.

17. The method of claim 16, wherein said antioxidant is selected from the group consisting of Vitamin A, Vitamin B, Vitamin C, Vitamin E, Selenium, Cystine, Cysteine, BHT, BHA and Hydergine.

18. The method of claim 11, wherein accessing the cavity of the body of the patient or cadaver includes instrumentizing the cavity of the body at a body orifice.

19. The method of claim 18, wherein said instrumentizing the cavity of the body includes cannulating the body orifice.

20. A method of treating living tissue in mammals comprising:

a) providing a biocompatible solution, said solution comprising an effective amount of a free radical scavenger for inhibiting free radical damage and an effective amount of an oxygen carrying agent for transporting oxygen to said tissue;

b) bringing said biocompatible solution to a temperature substantially below body temperature; and

c) perfusing said biocompatible solution into a body cavity of said mammal.

21. The method of claim 20, wherein said oxygen carrying agent is selected from the group consisting of perfluorocarbons, hemoglobin based blood substitutes and non-hemoglobin based blood substitutes.

22. The method of claim 20, wherein said solution is approximately 40 degrees F.

23. The method of claim 20, additionally comprising the step of retrieving said biocompatible solution from said body cavity.

24. The method of claim 20, wherein said free radical scavenger is selected from the group consisting of antioxidants.

25. The method of claim 24, wherein said antioxidant is selected from the group consisting of Vitamin A, Vitamin B, Vitamin C, Vitamin E, Selenium, Cystine, Cysteine, BHT, BHA and Hydergine.

26. The method of claim 20, wherein said perfusing said biocompatible solution into said body cavity of said mammal includes the step of instrumentizing said body cavity of said mammal.

27. The method of claim 26, wherein said instrumentizing step includes piercing the skin of said mammal.

28. The method of claim 26, wherein said instrumentizing step includes cannulation of said mammal.

29. A method of treating living tissue in mammals comprising:

a) providing a biocompatible solution, said solution comprising an effective amount of a free radical scavenger for inhibiting free radical damage and an effective amount of an oxygen carrying agent for transporting oxygen to said tissue;

b) bringing said biocompatible solution to a temperature substantially below body temperature; and

c) infusing said biocompatible solution into at least one cavity of the body of said mammal.

30. The method of claim 29, wherein said cavity of the body of said mammal is selected from the group consisting of the gastro-intestinal tract, the respiratory tract and the urinary tract.

31. The method of claim 29, wherein said oxygen carrying agent is selected from the group consisting of perfluorocarbons, hemoglobin based blood substitutes and non-hemoglobin based blood substitutes.

32. The method of claim 29, additionally comprising the step of retrieving said biocompatible solution from said cavity of the body.

33. The method of claim 29, wherein said free radical scavenger is selected from the group consisting of antioxidants.

34. The method of claim 33, wherein said antioxidant is selected from the group consisting of Vitamin A, Vitamin B, Vitamin C, Vitamin E, Selenium, Cystine, Cysteine, BHT, BHA and Hydergine.

35. The method of claim 29, wherein said solution is approximately 40 degrees F.

36. The method of claim 29, wherein said infusing said biocompatible solution into said cavity of the body of said mammal includes the step of instrumentizing said cavity of the body of said mammal at a body orifice.

37. The method of claim 36, wherein said instrumentizing step includes cannulation of said mammal.