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

• US 8,609,400 B2
• Filed: 05/12/2010
• Issued: 12/17/2013
• 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, Schein, Douglas
• Primary Examiner(s): Beisner, William H
• Application Number:
  US12/662,930
• Publication Number:
  US 20100221696A1
• Time in Patent Office: 1,315 Days
• Field of Search: 435/1.2, 435/284.1, 206/522, 206/583
• 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. 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 system for holding an organ during perfusion, storage and transport of the organ, comprising:

an organ cassette for holding the organ, the organ cassette including

an organ supporting surface that supports the organ, and

two lids connected or connectable to the organ cassette;

each of the two lids individually forming a substantially airtight seal with the organ cassette;

a perfusion circuit configured to provide recirculating perfusion for the organ;

a transporter having a compartment structured to receive and support the organ cassette, the transporter being a portable organ perfusion apparatus,

wherein the organ cassette is configured (1) to hold the organ independently from the transporter, (2) to be received by the transporter, without jeopardizing sterility of an interior of the organ cassette, for transport of the organ, (3) to be removed from the transporter without jeopardizing sterility of the interior of the organ cassette and without removal of the organ from the organ cassette, and (4) to allow the recirculating perfusion, storage, and transport of the organ without removal of the organ from the organ cassette.

2. The system according to claim 1, wherein the organ supporting surface is structured to allow fluids to pass therethrough.

3. The system according to claim 1, wherein the organ cassette is transparent.

4. The system according to claim 1, wherein the organ supporting surface is a mesh material.

5. The system according to claim 1, wherein the organ cassette includes at least one of tubing and a connector to allow connection of the organ in the organ cassette to tubing of the perfusion circuit.

6. The system of claim 1, wherein at least a portion of the transporter includes transferable data regarding at least one of the transporter and contents of the transporter.

7. The system of claim 6, further comprising a transmitter or a global positioning system, wherein the transferable data is in the transmitter or the global positioning system.

8. The system of claim 6, wherein the transferrable data includes a location of the transporter, perfusion information about the organ, or information about vascular resistance of the organ.

9. The system of claim 1, wherein a bottom portion of the cassette is liquid-tight and configured to collect medical fluid that has passed through a perfused organ to form an organ bath.

10. The system of claim 1, wherein the transporter is interfaced to a computer network.

11. The system according to claim 1, wherein the organ cassette is movable to and from the organ transporter without opening the organ cassette.

12. A method of using the system according to claim 1, comprising:

perfusing an organ in said system at normothermic temperatures to repair damage to the organ;

perfusing the organ at hypothermic temperatures following the perfusing the organ at normothermic temperatures.

13. The method of claim 12, wherein the perfusing the organ at hypothermic temperatures includes perfusing the organ with a perfusate with substantially no oxygen.

14. The method of claim 12, wherein the perfusing the organ at normothermic temperatures includes perfusing the organ with an oxygenated perfusate.

15. The method of claim 12, further comprising determining viability of the organ by analyzing differentially the perfusate flowing into and out of the organ.

16. The method of claim 15, wherein determining the viability of the organ occurs after the perfusing the organ at normothermic temperatures and before the perfusing the organ at hypothermic temperatures.

17. A method of using the system according to claim 1, comprising:

perfusing an organ in said system at hypothermic temperatures with an oxygenated perfusate.

20. A method of using the system of claim 1, comprising:

placing the organ in the cassette;

placing the cassette containing the organ in the transporter and perfusing the organ in the cassette in the transporter without removal of the organ from the cassette;

transporting the organ in the cassette in the transporter without removal of the organ from the cassette; and

transferring data regarding at least one of the cassette and the organ from at least a portion of the transporter.

21. The method of claim 20, wherein the data to be transferred is in the form of at least one of a transmitter and global positioning system.

22. The method of claim 21, wherein the data to be transferred includes information about at least one of an organ in the cassette and a location of the cassette.

23. The method of claim 22, wherein the information about the organ in the cassette includes perfusion information about the organ and vascular resistance of the organ.

24. The method of claim 21, further comprising transferring the data wirelessly to a remote location for at least one of managing, tracking, monitoring, and diagnosing the organ.

18. A system for holding an organ during perfusion, storage and transport of the organ, comprising:

a portable housing for holding the organ, the portable housing including two lids connected or connectable to the portable housing;

each of the two lids individually forming a substantially airtight seal with the portable housing;

a perfusion circuit configured to provide recirculating perfusion for the organ;

an organ perfusion apparatus adapted to receive the portable housing; and

a transporter adapted to receive the portable housing, the transporter being a portable organ perfusion apparatus,

wherein the organ perfusion apparatus and the transporter are separate units and the portable housing is configured (1) to hold the organ independently from either of the organ perfusion apparatus or the transporter, (2) to be received by the transporter for transport of the organ without jeopardizing sterility of an interior of the portable housing, (3) to be separately received by the organ perfusion apparatus, without jeopardizing sterility of the interior of the portable housing, for perfusion of the organ, and (4) to allow the recirculating perfusion, storage, and transport of the organ without removal of the organ from the portable housing.

19. The system of claim 18, wherein the portable housing includes a handle.

25. A system for holding an organ during perfusion, storage and transport of the organ, comprising:

an organ cassette for holding the organ, the organ cassette including;

an organ supporting surface that supports the organ, and

a first lid and a second lid connected or connectable to the organ cassette;

the first lid and the second lid each having a port configured to allow access to the organ;

the ports in the first lid and the second lid being aligned substantially along a vertical line;

a perfusion circuit configured to provide recirculating perfusion for the organ;

a transporter having a compartment structured to receive and support the organ cassette, the transporter being a portable organ perfusion apparatus,

wherein the organ cassette is configured (1) to hold the organ independently from the transporter, (2) to be received by the transporter, without jeopardizing sterility of an interior of the organ cassette, for transport of the organ, (3) to be removed from the transporter without jeopardizing sterility of the interior of the organ cassette and without removal of the organ from the organ cassette, and (4) to allow the recirculating perfusion, storage, and transport of the organ without removal of the organ from the organ cassette.