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

• US 20110183310A1
• Filed: 03/29/2011
• Published: 07/28/2011
• Est. Priority Date: 08/25/2000
• Status: Active Grant

• Current Assignee: Lifeline Scientific, Inc. (Shanghai Genext Medical Technology Co., Ltd.)
• Original Assignee: Lifeline Scientific, Inc. (Shanghai Genext Medical Technology Co., Ltd.)
• Inventors: Kravitz, David C., Schein, Douglas, Burroughs, Andrew, Brassil, John, Isaacs, Dickon, Brockbank, Kelvin G.M.
• Granted Patent: US 8,323,954 B2
• Time in Patent Office: Days
• 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

Abstract

An organ perfusion apparatus and method monitor, sustain and/or restore viability of organs and preserve organs for storage and/or transport. Other apparatus include an organ transporter, an organ cassette and an organ diagnostic device. 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. An organ perfusion system for perfusing an organ comprising:

a first pump fluidly connected to a first perfusion circuit; and

a second pump fluidly connected to a second perfusion circuit;

wherein the first perfusion circuit is configured to connect to a first area of the organ and the second perfusion circuit is configured to connect to a second area of the organ.

2. The organ perfusion system according to claim 1, wherein the organ is a liver and the first area is a hepatic artery of the liver and the second area is a portal vein of the liver.

3. The organ perfusion system according to claim 1, further comprising:

an organ cassette for holding the organ;

wherein the first perfusion circuit and the second perfusion circuit pass into and/or out of the organ cassette by way of at least one opening in the organ cassette.

4. The organ perfusion system according to claim 1, wherein at least one of the first perfusion circuit and the second perfusion circuit provide oxygenation to a perfusate.

5. The organ perfusion system according to claim 1, wherein the first perfusion circuit provides oxygenation to a first perfusate and the second perfusion circuit provides oxygenation to a second perfusate.

6. The organ perfusion system according to claim 1, wherein the organ is perfused at normothermic temperature.

7. The organ perfusion system according to claim 1, wherein the first perfusion circuit and the second perfusion circuit are independent from one another.

8. The organ perfusion system according to claim 1, wherein the first perfusion circuit and the second perfusion circuit have different flow rates.

9. The organ perfusion system according to claim 1, wherein the first perfusion circuit provides pulsatile flow and the second perfusion circuit provides continuous flow.

10. The organ perfusion system according to claim 1, wherein:

the first perfusion circuit further comprises a first pressure sensor and a first flow sensor, and

the second perfusion circuit further comprises a second pressure sensor and a second flow sensor.

11. A method for perfusing an organ comprising:

fluidly connecting a first pump and a first perfusion circuit to a first area of the organ;

fluidly connecting a second pump and a second perfusion circuit to a second area of the organ;

perfusing the first area of the organ with the first pump and the first perfusion circuit; and

perfusing the second area of the organ with the second pump and the second perfusion circuit.

12. The method for perfusing an organ according to claim 11, wherein the organ is a liver, the first area is a hepatic artery of the liver, and the second area is a portal vein of the liver.

13. The method for perfusing an organ according to claim 11, further comprising:

placing the organ in an organ cassette to hold the organ; and

passing the first perfusion circuit and the second perfusion circuit into and/or out of the organ cassette by way of at least one opening in the organ cassette.

14. The method for perfusing an organ according to claim 11, further comprising:

oxygenating a perfusate in at least one of the first perfusion circuit and the second perfusion circuit.

15. The method for perfusing an organ according to claim 11, oxygenating a first perfusate in the first perfusion circuit and oxygenating a second perfusate in the second perfusion circuit.

16. The method for perfusing an organ according to claim 11, wherein the perfusing of the first area and the perfusing of the second area are at normothermic temperature.

17. The method for perfusing an organ according to claim 11, wherein the perfusing of the first area and the perfusing of the second area are at different flow rates.

18. The method for perfusing an organ according to claim 11, wherein the perfusing of the first area comprises a pulsatile flow and the perfusing of the second area comprises a continuous flow.

19. The method for perfusing an organ according to claim 11, further comprising:

monitoring the first perfusion circuit with a first pressure sensor and a first flow sensor, and

monitoring the second perfusion circuit with a second pressure sensor and a second flow sensor.

20. The method for perfusing an organ according to claim 19, further comprising:

controlling the perfusing of the first area based on the monitoring of the first perfusion circuit, and

controlling the perfusing of the second area based on the monitoring of the second perfusion circuit.