ASSESSING, MAINTAINING AND/OR RESTORING VIABILITY OF ORGANS/TISSUES

• US 20120315618A1
• Filed: 06/07/2012
• Published: 12/13/2012
• Est. Priority Date: 06/09/2011
• Status: Active Grant

• Current Assignee: Lifeline Scientific, Inc. (Shanghai Genext Medical Technology Co., Ltd.)
• Original Assignee: Cell & Tissue Systems, Inc., Lifeline Scientific, Inc. (Shanghai Genext Medical Technology Co., Ltd.)
• Inventors: KRAVITZ, David, BROCKBANK, Kelvin G. M., CAMPBELL, Lia H.
• Granted Patent: US 11,490,615 B2
• Time in Patent Office: Days
• US Class Current: 435/1.2
• CPC Class Codes: A01N 1/0247 for perfusion, i.e. for circulating fluid through organs, blood vessels or other living parts

Abstract

Methods for ex vivo perfusion of organs (and/or tissues) with a perfusate designed to condition the organ with the desired effect being that upon transplant, said organ, having been administered said perfusate, is less likely to experience delayed graft function, deleterious effects of ischemia/reperfusion injury, including inflammatory reactions, and/or other detrimental responses that can injure the organ or recipient including precipitating or enhancing an immunological reaction from the recipient with the potential of compromising the graft'"'"'s and/or recipients short teen and/or long term health and proper functionality while monitoring, sustaining and/or restoring the viability of the organ and preserving the organ for storage and/or transport.

Claims

1. A method of determining parameters for maintaining viability of at least one organ in at least one device selected from an organ transporter, perfusion apparatus, cassette, and organ diagnostic apparatus, the method comprising:

forming a data record by uploading to a processor compiled data comprising;

data relating to one or more qualitative and/or quantitative relationships of one or more predetermined biomarkers while organs were preserved, transported and/or stored in at least one device selected from an organ transporter, perfusion apparatus, cassette, and organ diagnostic apparatus; and

events occurring while organs were transported and/or stored in at least one device selected from an organ transporter, perfusion apparatus, cassette, and organ diagnostic apparatus, and

data relating to outcomes of transplantation of said organs; and

using the same processor or a different processor to determine transport parameters of the at least one device or a different device, based on the data record, for maintaining viability of at least one other organ.

4. The method of claim 1, further comprising:

disseminating the data record.

5. The method of claim 1, further comprising:

storing the data record in a database.

6. The method of claim 1, further comprising:

transmitting the data record over a network.

7. The method of claim 6, wherein the network is at least one of a local area network and the World Wide Web.

8. The method of claim 1, wherein the same processor or different processor at least one of manages, tracks, monitors, and diagnoses the at least one other organ.

9. The method of claim 1, wherein the at least one same or different organ transporter is configured with a wireless communications setup to provide real-time data transfer.

10. The method of claim 1, further comprising:

producing an organ viability index for the at least one other organ.

2. A method of monitoring, maintaining, and/or restoring viability of at least one organ in at least one device selected from an organ transporter, perfusion apparatus, cassette, and organ diagnostic apparatus, the method comprising:

monitoring data comprising information relating to one or more qualitative and/or quantitative relationships of one or more predetermined biomarkers while the at least one organ is preserved, transported and/or stored in at least one device selected from an organ transporter, perfusion apparatus, cassette, and organ diagnostic apparatus, and events occurring while the at least one organ is present in the at least one of an organ transporter, perfusion apparatus, cassette, and/or organ diagnostic apparatus to form a data record; and

connecting the at least one of the organ transporter, perfusion apparatus, cassette, and/or organ diagnostic apparatus to a network through wiring or wirelessly, and uploading the data record to a database.

11. The method of claim 2, further comprising:

transferring the data to a memory device, wherein the data record is transferred to the memory device before connecting at least one of the transporter, perfusion apparatus, cassette, and organ diagnostic apparatus to the network.

12. The method of claim 2, further comprising at least one of displaying, accessing, and uploading the data record from the database via either the same network or a different network connected to the database.

13. The method of claim 12, wherein the same or different network is at least one of a local area network and the World Wide Web.

14. The method of claim 2, further comprising:

transferring the data record to a remote location for at least one of managing, tracking, monitoring, and diagnosing the at least one organ.

15. The method of claim 2, wherein at least one of the transporter, perfusion apparatus, cassette, and organ diagnostic apparatus is configured with a wireless communications setup to provide real-time data transfer.

16. The method of claim 2, further comprising:

producing a first organ viability index based on the data record.

17. The method of claim 16, further comprising:

making organ therapy decisions based on the first organ viability index.

18. The method of claim 17, further comprising:

comparing the first organ viability index with a second organ viability index.

25. The method of claim 2, further comprising:

producing an organ viability index of the at least one organ.

3. A method of transporting and/or storing at least one organ in at least one device selected from an organ transporter, perfusion apparatus, cassette, and/or organ diagnostic apparatus, the method comprising:

adjusting transport and/or storage parameters of at least one device for the transport and/or storage of at least one organ based on a data record of organ transport and/or storage, the data record comprising;

information relating to one or more qualitative and/or quantitative relationships of one or more predetermined biomarkers while the at least one same or different organ was preserved, transported and/or stored in at least one device selected from an organ transporter, perfusion apparatus, cassette, and organ diagnostic apparatus, and events occurring while the at least one same or different organ was transported and/or stored in a least one same or different device, wherein the information is cross-referenced to outcome data relating to outcomes of transplantation of the at least one same or different organ that was transported and/or stored.

19. The method of claim 3, further comprising:

receiving the data record over a wireless network.

20. The method of claim 3, wherein the data record is obtained from a database computer.

21. The method of claim 19, wherein the database computer at least one of manages, tracks, monitors, and diagnoses the at least one organ in the at least one device in real-time.

22. The method of claim 3, further comprising at least one of displaying, accessing, and downloading the data record via a network.

23. The method of claim 3, wherein the at least one device is configured with a wireless communications setup to provide real-time data transfer.

24. The method of claim 3, wherein the information is cross-referenced to outcome data at the same location at which the at least one device is located.