Apparatus and method for maintaining and/or restoring viability of organs

• US 20060063142A1
• Filed: 10/25/2005
• Published: 03/23/2006
• Est. Priority Date: 09/29/1998
• Status: Active Grant

• Current Assignee: Lifeline Scientific, Inc. (Shanghai Genext Medical Technology Co., Ltd.)
• Original Assignee: Organ Recovery Systems, Inc. (Shanghai Genext Medical Technology Co., Ltd.)
• Inventors: Kravitz, David C., Owen, Donald R.
• Granted Patent: US 8,268,547 B2
• Time in Patent Office: Days
• US Class Current: 435/1.300
• 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 at least one of maintaining and restoring the viability of at least one organ subjected to a period of ischemia or hypoxia, comprising:

perfusing said at least one organ with a first medical fluid at a first temperature to at least one of maintain and restore pre-ischemia or pre-hypoxia energy levels in the organ; and

perfusing the organ with a second medical fluid containing substantially no oxygen at a second temperature to at least one of store and transport the organ, wherein said second temperature is lower than said first temperature.

2. The method of claim 1, wherein the first temperature is up to about 25°

C.

3. The method of claim 1, wherein the first temperature is from about 12°

C. to about 24°

C.

4. The method of claim 1, wherein the first temperature is at least about 15°

C.

5. The method of claim 1, wherein the first temperature is about room temperature.

6. The method of claim 1, wherein the first temperature is from about 20°

C. to about 25°

C.

7. The method of claim 1, wherein the first temperature is from about 20°

C. to about 38°

C.

8. The method of claim 1, wherein the first temperature is from about 20°

C. to about 35°

C.

9. The method of claim 1, wherein the second temperature is from about 1°

C. to about 15°

C.

10. The method of claim 1, wherein the second temperature is from about 4°

C. to about 10°

C.

11. The method of claim 1, wherein the first temperature is from about 12°

C. to about 24°

C. and the second temperature is at most 15°

C.

12. The method of claim 1, wherein the first temperature is at least about 20°

C. and the second temperature is at most 15°

C.

13. The method of claim 1, wherein the second temperature is from about 4°

C. to about 10°

C.

14. The method of claim 12, wherein the second temperature is from about 4°

C. to about 10°

C.

15. The method of claim 1, wherein the first medical fluid is an oxygenated solution.

16. The method of claim 15, wherein the first medical fluid is an oxygenated hemoglobin-based solution and the second fluid is a simple crystalloid solution augmented with antioxidants.

17. The method of claim 1, wherein the second medical fluid comprises at least one member selected from the group consisting of an oxygen carrier, a free radical scavenger, a pituitary growth factor extract and cell culture media.

18. The method of claim 17, wherein the first medical fluid comprises at least one viability marker.

19. The method of claim 1, wherein the first and second fluids are the same medical fluid.

20. A method of at least one of maintaining and restoring the viability of at least one organ subjected to a period of ischemia or hypoxia, comprising:

perfusing said at least one organ with a medical fluid at a first temperature to at least one of maintain and restore pre-ischemia or pre-hypoxia energy levels in the organ the first temperature is from about 20°

C. to about 24°

C.; and

perfusing the organ with the medical fluid at a second temperature to at least one of store and transport the organ, wherein said second temperature is lower than said first temperature, wherein the second temperature is from about 4°

C. to about 10°

C.