Method of transporting and storing a kidney

• US 8,268,547 B2
• Filed: 10/25/2005
• Issued: 09/18/2012
• Est. Priority Date: 09/29/1998
• Status: Expired due to Term

• Current Assignee: Lifeline Scientific, Inc. (Shanghai Genext Medical Technology Co., Ltd.)
• Original Assignee: Lifeline Scientific, Inc. (Shanghai Genext Medical Technology Co., Ltd.)
• Inventors: Owen, Donald R., Kravitz, David C.
• Primary Examiner(s): SAUCIER, SANDRA E
• Application Number:
  US11/257,066
• Publication Number:
  US 20060063142A1
• Time in Patent Office: 2,520 Days
• Field of Search: None
• US Class Current: 435/1.2
• CPC Class Codes: A01N 1/02 Preservation of living parts
• CPC Class Codes: A01N 1/0247 for perfusion, i.e. for circulating fluid through organs, blood vessels or other living parts
• CPC Class Codes: A01N 1/0273 Transport containers A01N1/0268 takes precedence
• CPC Class Codes: G06F 16/955 using information identifiers, e.g. uniform resource locators [URL]
• CPC Class Codes: H04L 67/02 based on web technology, e.g. hypertext transfer protocol [HTTP]

Abstract

An organ perfusion apparatus and method monitor, sustain and/or restore viability of organs and preserve organs for storage and/or transport. The method includes perfusing the organ at hypothermic and/or normothermic temperatures, preferably after hypothermic organ flushing for organ transport and/or storage. The method can be practiced with prior or subsequent static or perfusion hypothermic exposure of the organ. Organ viability is restored by restoring high energy nucleotide (e.g., ATP) levels by perfusing the organ with a medical fluid, such as an oxygenated cross-linked hemoglobin-based bicarbonate medical fluid, at normothermic temperatures. In perfusion, organ perfusion pressure is preferably controlled in response to a sensor disposed in an end of tubing placed in the organ, by a pneumatically pressurized medical fluid reservoir, providing perfusion pressure fine tuning, overpressurization prevention and emergency flow cut-off. In the hypothermic mode, the organ is perfused with a medical fluid, preferably a simple crystalloid solution containing antioxidants, intermittently or in slow continuous flow. The medical fluid may be fed into the organ from an intermediary tank having a low pressure head to avoid organ overpressurization. Preventing overpressurization prevents or reduces damage to vascular endothelial lining and to organ tissue in general. Viability of the organ may be automatically monitored, preferably by monitoring characteristics of the medical fluid perfusate. The perfusion process can be automatically controlled using a control program.

Claims

1. A method of transporting and storing a kidney, comprising, in sequence:

a. assessing that damage has been caused to the kidney from warm ischemia;

b. perfusing said kidney at a normothermic temperature to repair damage from warm ischemia;

c. perfusing said kidney at a hypothermic temperature;

d. at least one of transporting and storing said kidney at a hypothermic temperature; and

e. perfusing said kidney at a normothermic temperature to repair damage from the hypothermic transport or storage of step d,

wherein said normothermic perfusing steps b and e are performed with an oxygenated perfusion fluid,

the method is performed using a single organ perfusion apparatus,

normothermic temperatures are from 10°

C. to 38°

C.,

hypothermic temperatures are from 1°

C. to 15°

C., and

the hypothermic temperatures are lower than the normothermic temperatures.

2. The method of claim 1, wherein step d comprises transporting said kidney, and said method further comprises:

f. perfusing said kidney at a hypothermic temperature after step e.

3. The method of claim 2, further comprising:

g. storing said kidney at a hypothermic temperature after step e.

4. The method of claim 2, further comprising transplanting said kidney after step f.

5. The method of claim 1, wherein step d comprises transporting said kidney to a storage facility, and said method further comprises:

f. perfusing said kidney at a hypothermic temperature and storing said kidney at a hypothermic temperature at said storage facility after step d.

6. The method of claim 5, further comprising:

g. perfusing said kidney at a normothermic temperature to repair damage from the hypothermic storage of step e;

h. perfusing said kidney at a hypothermic temperature; and

i. transporting said kidney to a transplant facility at a hypothermic temperature.

7. The method of claim 6, further comprising transplanting said kidney after step i.

8. The method of claim 6, further comprising:

j. perfusing said kidney at a normothermic temperature to repair damage from the hypothermic transport of step i;

k. perfusing said kidney at a hypothermic temperature; and

l. transplanting said kidney.

9. The method of claim 1, wherein the hypothermic temperatures are from 4°

C. to 10°

C.

10. The method of claim 1, wherein said hypothermic perfusing step c is performed with a non-oxygenated perfusion fluid.

11. The method of claim 1, wherein the normothermic temperatures are from 18°

C. to 24°

C.

12. The method of claim 1, further comprising assessing the damage of step e by way of markers in a perfusate solution before performing step e.

13. The method of claim 1, wherein the single organ perfusion apparatus is a portable organ perfusion apparatus.

14. A method of transporting and storing a kidney, comprising, in sequence:

a. perfusing said kidney at a first temperature to repair damage from warm ischemia;

b. perfusing said kidney at a second temperature, wherein said second temperature is less than said first temperature;

c. at least one of transporting and storing said kidney at a third temperature, wherein said third temperature is greater than said second temperature; and

d. perfusing said kidney at a fourth temperature to repair damage from the transport or storage of step c,

wherein the method is performed using a single organ perfusion apparatus.

15. The method of claim 14, wherein said perfusing steps a and d are performed at normothermic temperatures from 10°

C. to 38°

C. and steps b and c are performed at hypothermic temperatures from 1°

C. to 15°

C.

16. The method of claim 15, wherein at least one of the hypothermic temperatures is from 4°

C. to 10°

C.

17. The method of claim 15, wherein at least one of the normothermic temperatures is from 18°

C. to 24°

C.

18. The method of claim 14, wherein said perfusing steps a and d are performed with an oxygenated perfusion fluid and said perfusing step b is performed with a non-oxygenated perfusion fluid.

19. The method of claim 14, wherein step c comprises transporting said kidney, and said method further comprises:

e. perfusing said kidney at a hypothermic temperature after step d.

20. The method of claim 19, further comprising:

f. storing said kidney at a hypothermic temperature after step e.

21. The method of claim 19, further comprising transplanting said kidney after step e.

22. The method of claim 14, wherein step c comprises transporting said kidney to a storage facility, and said method further comprises:

e. perfusing said kidney at a hypothermic temperature and storing said kidney at a hypothermic temperature at said storage facility after step d.

23. The method of claim 22, further comprising:

f. perfusing said kidney at a normothermic temperature to repair damage from the hypothermic storage of step e;

g. perfusing said kidney at a hypothermic temperature; and

h. transporting said kidney to a transplant facility at a hypothermic temperature.

24. The method of claim 23, further comprising transplanting said kidney after step h.

25. The method of claim 23, further comprising:

i. perfusing said kidney at a normothermic temperature to repair damage from the hypothermic transport of step h;

j. perfusing said kidney at a hypothermic temperature; and

k. transplanting said kidney.

26. The method of claim 14, further comprising, before step a, assessing that damage has been caused to the kidney from warm ischemia.

27. The method of claim 14, further comprising assessing the damage of step d by way of markers in a perfusate solution before performing step d.

28. The method of claim 14, wherein the single organ perfusion apparatus is a portable organ perfusion apparatus.