Apparatus and method for perfusion and determining the viability of an organ

• US 8,741,555 B2
• Filed: 05/14/2004
• Issued: 06/03/2014
• Est. Priority Date: 05/14/2004
• Status: Active Grant

• Current Assignee: Organ Recovery Systems, Inc. (Shanghai Genext Medical Technology Co., Ltd.)
• Original Assignee: Organ Recovery Systems, Inc. (Shanghai Genext Medical Technology Co., Ltd.)
• Inventors: Brassil, John, Baicu, Simona
• Primary Examiner(s): Ware, Debbie K
• Application Number:
  US10/845,154
• Publication Number:
  US 20050255442A1
• Time in Patent Office: 3,672 Days
• Field of Search: None
• 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: A61B 5/14525 using microdialysis
• CPC Class Codes: A61B 5/413 Monitoring transplanted tissue or organ, e.g. for possible rejection reactions after a transplant

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. During the period in which the organ is preserved and/or maintained, the organ may be additionally be perfused to obtain data regarding the fluid and/or organ. The data may then be used to ultimately provide information regarding the perfusion efficacy and allow for altering of the perfusion parameters.

Claims

1. A method of determining at least one characteristic of at least one specific area of an organ, comprising:

perfusing the organ with an oxygen rich fluid to maintain viability of the organ;

placing at least one device at or in at least one specific area of the organ where the at least one characteristic of the specific area of the organ will be monitored;

separately from the perfusing, supplying a first medical fluid to the at least one specific area of the organ, and not the entire organ, and performing microdialysis at the at least one specific area of the organ, wherein the first medical fluid is a dialysate; and

monitoring an output of the at least one device, wherein the output is at least one of a sensed electrical characteristic and a sensed chemical characteristic of only the at least one specific area of the organ.

2. The method of claim 1, wherein at least one of the at least one device contains a second medical fluid.

3. The method of claim 2, further comprising allowing at least one of a fluid exposure and a fluid exchange through a semipermeable membrane between the second medical fluid and fluid located in the organ at or near the at least one specific area.

4. The method of claim 3, further comprising generating data based on the at least one fluid exposure or exchange between the second medical fluid of the at least one device and fluid located in the organ at or near the at least one specific area.

5. The method of claim 4, further comprising at least one of displaying the generated data in real time, storing the generated data, transmitting the generated data to a remote site, transferring the generated data to a recording medium, and transmitting the generated data to a microprocessor.

6. The method of claim 1, further comprising adjusting the perfusion of the organ based on the output.

7. The method of claim 4, wherein the output relates to at least one of pH, ion levels, metabolism, excretion, and gas levels.

8. The method of claim 3, further comprising:

supplying the second medical fluid to the at least one device through a first tube; and

removing a third medical fluid from the at least one device through a second tube.

9. The method of claim 8, further comprising collecting the third medical fluid.

10. The method of claim 9, further comprising sensing at least one of an electrical characteristic and a chemical characteristic of the at least one specific area of the organ from the collected third medical fluid.

11. The method of claim 10, further comprising comparing the at least one electrical or chemical characteristic of the third medical fluid to at least one characteristic of the first and second medical fluids.

12. The method of claim 11, wherein characteristics of the second medical fluid are known.

13. The method of claim 11, wherein the comparing is performed by a fluid-testing device.

14. The method of claim 11, further comprising generating data based on the compared characteristics.

15. The method of claim 14, further comprising transferring the generated data wirelessly to a remote location for at least one of managing, tracking, monitoring, and diagnosing the organ.

16. The method of claim 14, further comprising transferring the generated data to a computer network, wherein the computer network at least one of manages, tracks, monitors, and diagnoses the organ.

17. The method of claim 16, further comprising at least one of displaying, accessing, and uploading the data from the computer network, wherein the computer network is at least one of a local area network and the Internet.

18. The method of claim 10, wherein the electrical or chemical characteristic relates to at least one of pH, ion levels, metabolism, excretion and gas levels.

19. The method of claim 4, wherein the first and second medical fluids are different fluids.

20. The method of claim 4, wherein the first and second medical fluids are the same fluids.

21. The method of claim 1, wherein at least one of the at least one device is a sensor.

22. The method of claim 21, wherein the sensor is a solid-state transducer.

23. The method of claim 21, wherein the at least one device includes a microprocessor that generates data based on at least one of the sensed electrical characteristic and sensed chemical characteristic of the at least one specific area of the organ.

24. The method of claim 23, wherein the microprocessor causes the data to be at least one of displayed in real time, stored, transmitted to a remote site, and transferred to a recording medium.

25. The method of claim 24, further comprising controlling the perfusion based on the at least one sensed electrical or chemical characteristics.

26. The method of claim 23, wherein the at least one sensed electrical or chemical characteristic relates to at least one of pH, ion levels, metabolism, excretion, and gas levels.

27. The method of claim 1, wherein only the at least one specific area of the organ is supplied with the first medical fluid.

28. The method of claim 1, further comprising monitoring at least one of pH, ion levels, metabolism, excretion, or gas levels of the oxygen rich fluid that has been passed through the organ.

29. The method of claim 28, wherein the monitoring at least one of pH, ion levels, metabolism, excretion, or gas levels of the outflow of the oxygen rich fluid that was perfused to maintain viability of the organ occurs simultaneously with the monitoring of the output of the at least one device, wherein the output is at least one of a sensed electrical characteristic and a sensed chemical characteristic of only the at least one specific area of the organ.

30. The method of claim 29, further comprising at least one of displaying the generated data in real time, storing the generated data, transmitting the generated data to a remote site, transferring the generated data to a recording medium, and transmitting the generated data to a microprocessor.

31. The method of claim 29, further comprising adjusting the perfusion of the organ based on the at least one of pH, ion levels, metabolism, excretion, or gas levels of the outflow of the oxygen rich fluid that was perfused to maintain viability of the organ and the output of the at least one device, wherein the output is at least one of a sensed electrical characteristic and a sensed chemical characteristic of only the at least one specific area of the organ.