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

• US 20110053256A1
• Filed: 11/05/2010
• Published: 03/03/2011
• Est. Priority Date: 09/29/1998
• 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, Owen, Donald R., Fraser, Richard, Brassil, John, Harris, Stanley, Steibel, Dennis J., Isaacs, Dickon, Brockbank, Kelvin G.M.
• Granted Patent: US 8,420,381 B2
• Time in Patent Office: Days
• 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. A organ transporting device, comprising:

an organ perfusion system; and

a data logger and/or transmitter.

2. The organ transporting device according to claim 1, wherein the data logger and/or transmitter is a global positioning system.

3. The organ transporting device according to claim 2, wherein the global positioning system allows tracking of the location of the organ transporting device.

4. The organ transporting device according to claim 1, wherein the data logger and/or transmitter allows monitoring of an organ in the organ transporting device at a location of the apparatus.

5. The organ transporting device according to claim 1, wherein the data logger and/or transmitter allows monitoring of an organ in the organ transporting device at a location other than a location of the apparatus.

6. The organ transporting device according to claim 1, wherein conditions experienced by the system are detected and monitored.

7. The organ transporting device according to claim 1, wherein conditions experienced by an organ are detected and or monitored.

8. The organ transporting device according to claim 1, wherein conditions experienced by a perfusate are detected and monitored.

9. The organ transporting device according to claim 6, wherein the conditions are compared with pre-stored operating conditions.

10. The organ transporting device according to claim 9, wherein a signal is generated based on the comparison, the signal being indicative of viability of an organ.

11. The organ transporting device according to claim 1, wherein the data logger and/or transmitter logs and/or transmits data from at least one of a pressure sensor, a pH detector, an oxygen sensor, and a flow meter.

12. The organ transporting device according to claim 1, wherein the data logger and/or transmitter logs and/or transmits data from a pressure sensor, a pH detector, an oxygen sensor, and a flow meter.

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

a portable housing;

an organ supporting surface configured to support an organ within said housing, wherein the portable housing is configured to be received by at least one of an organ perfusion device, an organ transporter and an organ diagnostic device, and includes openings configured to allow tubing to be connected to the organ by way of the openings, wherein a bottom portion of the housing is liquid tight, and wherein said organ supporting surface or said housing comprises detents, tracks or grooves that interact with a protruding region of said tubing to allow said cannula to be secured at various positions on the detents, tracks or grooves of the organ supporting surface or the housing.

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

a portable housing;

an organ supporting surface configured to support an organ within said housing, wherein the portable housing is configured to be received by at least one of an organ perfusion device, an organ transporter and an organ diagnostic device, and includes openings configured to allow tubing to be connected to the organ by way of the openings, wherein a bottom portion of the housing is liquid tight, and wherein said portable housing is associated with a video camera or still camera to record the status or progress of the organ and/or organ perfusion.

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

a portable housing;

an organ supporting surface configured to support an organ within said housing, wherein the portable housing is configured to be received by at least one of an organ perfusion device, an organ transporter and an organ assessment device, and includes openings configured to allow tubing to be connected to the organ by way of the openings, and wherein a bottom portion of the housing is liquid-tight; and

a first lid and a second lid for the housing.

16. A kit comprising:

a saleable package containing a portable housing, a set of tubes, and an organ supporting surface, wherein the organ supporting surface is configured to support an organ within said portable housing, wherein the portable housing is configured to be received by at least one of an organ perfusion device, an organ transporter and an organ diagnostic device, and includes openings configured to allow the set of tubes to be connected to the organ by way of the openings, and wherein a bottom portion of the housing is liquid-tight.

17. A kit according to claim 16, wherein the set of tubes includes tubes for connecting the portable housing with an organ.

18. A kit according to claim 17, wherein the set of tubes further comprises tubes for connecting the portable housing to the organ perfusion apparatus.

19. A kit according to claim 16, further comprising an organ support configured to securely hold the organ while the tubes are connected to the organ.

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

a portable housing;

a tube set connectable to the portable housing;

an organ supporting surface configured to support an organ within said housing, wherein the portable housing is configured to be received by at least one of an organ perfusion device, an organ transporter and an organ diagnostic device, and includes openings configured to allow the tube set to be connected to the organ by way of the openings, wherein the portable housing and the tube set can be removed from at least one of the organ perfusion device, organ transporter and organ diagnostic device without exposing the organ, and wherein a bottom portion of the portable housing is liquid-tight.

21. 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.

22. The apparatus of claim 21, further comprising:

a pump and pulse controller.

23. The apparatus of claim 22, 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.

24. The apparatus of claim 21, 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.

25. The apparatus of claim 21, 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.

26. The apparatus of claim 21, wherein the organ supporting surface is configured to support a liver.

27. The apparatus of claim 21, 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.

28. 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 from a pressure sensor and converts the data into an output to drive the pump.

29. The apparatus of claim 28, wherein the pump and pulse controller reduces pressure pulse waves from perfusate flow.

30. The apparatus of claim 29, wherein the pump and pulse controller maintains a constant pressure wave in tubing to the organ and/or the organ.

31. The apparatus of claim 29, wherein the pump and pulse controller synthesizes a prescribed pressure wave to be conveyed into the organ.