Systems and methods for ex-vivo organ care and for using lactate as an indication of donor organ status

• US 9,894,894 B2
• Filed: 08/16/2012
• Issued: 02/20/2018
• Est. Priority Date: 10/07/2004
• Status: Active Grant

• Current Assignee: TransMedics, Inc. (TransMedics Group, Inc.)
• Original Assignee: TransMedics, Inc. (TransMedics Group, Inc.)
• Inventors: Hassanein, Waleed, Khayal, Tamer, Elbetanony, Ahmed, Lezberg, Paul, Cecere, Giovanni, Sousa, Dennis, Hansen, Elizabeth
• Primary Examiner(s): Beisner, William H
• Assistant Examiner(s): HENKEL, DANIELLE B
• Application Number:
  US13/587,810
• Publication Number:
  US 20130078710A1
• Time in Patent Office: 2,014 Days
• Field of Search: 435 12, 4352841
• 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

Abstract

The invention provides, in various embodiments, systems, devices and methods relating to ex-vivo organ care. In certain embodiments, the invention relates to maintaining an organ ex-vivo at near-physiologic conditions. The present application describes a method for using lactate measurement in the arterial and the venous blood lines of the Organ Care System Heart perfusion device to evaluate the: 1) The overall perfusion status of an isolated heart and 2) The metabolic status of an isolated heart and 3) the overall vascular patency of an isolated donor heart. This aspect of the present invention uses the property of myocardial cell'"'"'s unique ability to produce/generate lactate when they are starved for oxygen and metabolize/utilize lactate for energy production when they are well perfused with oxygen.

Claims

1. An organ care system configured to perfuse an ex vivo heart in a functioning state at near physiological conditions, the system comprising:

a chassis;

an organ chamber assembly mounted to the chassis for containing the ex vivo heart during perfusion in a functioning state at near physiological conditions, the organ chamber comprising;

a fluid conduit with a first interface configured to connect to an aorta of the heart and a second interface configured to connect to a pulmonary vein of the heart;

a Lactate A sensor configured to measure lactate in the first interface;

a Lactate V sensor configured to measure lactate in the second interface; and

a processor configured to calculate a Lactate V-A differential using lactate values measured by the Lactate A sensor and the Lactate V sensor,

wherein the processor is configured to calculate Lactate V-A differential at two different times,

wherein the processor is further configured to calculate a change in V-A differential between the two different times to correlate a change between the V-A lactate differentials over time with suitability of the heart for transplantation.

2. The system of claim 1, wherein the organ chamber assembly is disposable.

3. The system of claim 1 wherein the Lactate V-A differential is calculated at least once an hour.

4. The system of claim 1, comprising a flow select valve configured to control a flow of the perfusion fluid to the first and second interfaces.

5. The system of claim 1, further comprising:

a reservoir mounted to the chassis in fluid communication with the organ chamber assembly and configured to hold perfusion fluid for the heart.

6. The system of claim 1, further comprising:

a sensor for measuring aortic pressure.

7. The system of claim 6, wherein the processor is further configured to receive a perfusion pressure measurement from at least one of the sensors to evaluate a coronary vascular patency of the heart using both the perfusion pressure and at least one of the measured lactate values.

8. The system of claim 1, wherein the Lactate V-A differential is calculated at periodic intervals.

9. The system of claim 8, wherein the periodic interval is less than an hour.

10. The system of claim 9, wherein a total length of time that lactate values are measured is more than one hour.

11. An apparatus comprising:

an organ chamber assembly for containing the ex vivo heart during perfusion in a functioning state at near physiological conditions, the organ chamber comprising;

a first fluid channel configured to be coupled to an aorta of an ex vivo heart;

a second fluid channel configured to be coupled to a pulmonary vein of the heart;

a first sensor configured to measure a Lactate A level in the first fluid channel;

a second sensor configured to measure a Lactate V level in the second fluid channel;

a processor coupled to the first and second sensors; and

a memory coupled to the processor and including computer readable instructions that, when executed by the processor, cause the processor to;

calculate a Lactate V-A differential at two different times using the measurements provided by the first and second sensors; and

calculate a change in Lactate V-A differential between the two different times correlate the change between the Lactate V-A differentials over time with a suitability of the heart for transplantation.

12. The apparatus of claim 11, wherein the first and second fluid channels and the first and second sensors are disposable.

13. The apparatus of claim 11 wherein the Lactate V-A differential is calculated at least once an hour.

14. The apparatus of claim 11, comprising a flow select valve configured to control a flow of perfusion fluid through the first and second fluid channels.

15. The apparatus of claim 11 further comprising:

a chassis; and

a reservoir mounted to the chassis in fluid communication with at least one of the first and second fluid channels and configured to hold perfusion fluid for the heart.

16. The apparatus of claim 11, further comprising:

a sensor configured to measure aortic pressure.

17. The apparatus of claim 16, wherein the processor is further configured to receive a perfusion pressure measurement from the sensor to evaluate a coronary vascular patency of the heart using the aortic pressure and the lactate value.

18. The apparatus of claim 11, wherein the Lactate V-A differential is calculated at periodic intervals.

19. The apparatus of claim 18, wherein the periodic interval is less than an hour.

20. The apparatus of claim 19, wherein a total length of time that lactate values are measured is more than one hour.