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

• US 8,420,381 B2
• Filed: 11/05/2010
• Issued: 04/16/2013
• Est. Priority Date: 09/29/1998
• Status: Expired due to Fees

• 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., Brassil, John, Brockbank, Kelvin G. M., Burroughs, Andrew, Isaacs, Dickon, Steibel, Dennis J., Fraser, Richard, Harris, Stanley, Schein, Douglas
• Primary Examiner(s): Beisner, William H
• Application Number:
  US12/926,277
• Publication Number:
  US 20110053256A1
• Time in Patent Office: 893 Days
• Field of Search: 435/1.2, 435/284.1
• US Class Current: 435/284.1
• 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. 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 apparatus for holding an organ for at least one of perfusion, storage, diagnosis and transport of the organ, comprising:

a portable housing;

a pump; and

an organ supporting surface configured to support an organ within said housing,

wherein the pump is connected to at least one first tube directed to a first area of the organ and the pump is connected to at least one second tube directed to a second area of the organ, the at least one first tube having a first flow rate that is controlled differently than a second flow rate of the at least one second tube and the pump at least partially controls both the first and second flow rates differently.

2. The apparatus of claim 1, further comprising:

a pump and pulse controller.

3. The apparatus of claim 2, further comprising:

a valve connected to the at least one first tube; and

a valve connected to the at least one second tube, wherein the pump and pulse controller maintains perfusion by alternating pressure control between the valves.

4. The apparatus of claim 1, wherein a number of tubes directed to the first area of the organ differs from a number of tubes directed to the second area of the organ.

5. The apparatus of claim 1, wherein one side of the portable housing comprises one or more of a filter, bubble trap, pressure transducer, temperature transducer and a flow sensor and wherein another side of the portable housing comprises one or more of a filter, bubble trap, pressure transducer, temperature transducer and a flow sensor.

6. The apparatus of claim 1, wherein the organ supporting surface is configured to support a liver.

7. The apparatus of claim 1, wherein the at least one first tube is configured to be connected to a hepatic artery side of a liver and the at least one second tube is configured to be connected to a portal vein side of the liver.

8. The apparatus of claim 1, wherein the apparatus has only a single pump.

9. An apparatus for holding an organ for at least one of perfusion, storage, assessment and transport of the organ, comprising:

a portable housing;

a pump;

a pump and pulse controller; and

an organ supporting surface configured to support an organ within the housing, wherein the pump and pulse controller receives at least one of flow data, tachometer data and pressure data and converts the data into a motor drive wave, the motor drive wave being applied to a pressure wave of the pump to form an output pressure.

10. The apparatus of claim 9, wherein the pump and pulse controller reduces pressure pulse waves from perfusate flow.

11. The apparatus of claim 10, wherein the pump and pulse controller maintains a constant pressure wave in tubing to the organ and/or the organ.

12. The apparatus of claim 10, wherein the pump and pulse controller synthesizes a prescribed pressure wave to be conveyed into the organ.

13. The apparatus of claim 12, wherein a selected wave is added with a new amplitude as compared to an amplitude of the constant pressure wave.

14. The apparatus of claim 12, wherein a selected wave is added with a new pulse width as compared to a pulse width of the constant pressure wave.

15. An apparatus for holding an organ for at least one of perfusion, storage, diagnosis and transport of the organ, comprising:

a portable housing;

a pump; and

an organ supporting surface configured to support an organ within said housing,

wherein the pump is connected to at least one first tube directed to a first area of the organ and the pump is connected to at least one second tube directed to a second area of the organ, the at least one first tube having a first pressure that is controlled differently from a second pressure of the at least one second tube and the pump at least partially controls both the first and second pressure differently.

16. The apparatus of claim 15, further comprising:

a pump and pulse controller.

17. The apparatus of claim 16, further comprising:

a valve connected to the at least one first tube; and

a valve connected to the at least one second tube, wherein the pump and pulse controller maintains perfusion by alternating pressure control between the valves.

18. The apparatus of claim 15, wherein a number of tubes directed to the first area of the organ differs from a number of tubes directed to the second area of the organ.

19. The apparatus of claim 15, wherein one side of the portable housing comprises one or more of a filter, bubble trap, pressure transducer, temperature transducer and a flow sensor and wherein another side of the portable housing comprises one or more of a filter, bubble trap, pressure transducer, temperature transducer and a flow sensor.

20. The apparatus of claim 15, wherein the organ supporting surface is configured to support a liver.

21. The apparatus of claim 15, wherein the at least one first tube is configured to be connected to a hepatic artery side of a liver and the at least one second tube is configured to be connected to a portal vein side of the liver.

22. The apparatus of claim 15, wherein the apparatus has only a single pump.