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

• US 10,321,676 B2
• Filed: 12/29/2017
• Issued: 06/18/2019
• 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 H., Khayal, Tamer I., Elbetanony, Ahmed, Lezberg, Paul, Cecere, Giovanni, Sousa, Dennis, Hansen Bulger, Elizabeth
• Primary Examiner(s): Beisner, William H.
• Assistant Examiner(s): Henkel, Danielle B
• Application Number:
  US15/857,953
• Publication Number:
  US 20180153158A1
• Time in Patent Office: 536 Days
• 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 for perfusing a heart comprising:

a module including a chassis;

an organ chamber assembly mounted to the chassis for containing the heart during perfusion and including a fluid conduit with a first interface for connecting to an aorta of the heart and a second interface for connecting to a pulmonary vein of the heart, a Lactate A sensor for sensing lactate at the first interface, and a Lactate V sensor for sensing lactate at the second interface; and

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

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

3. The system of claim 1, wherein the processor is configured to calculate the Lactate V-A differential at least once an hour.

4. The system of claim 1, comprising a flow select valve for selecting between flowing perfusion fluid to the first interface and flowing the perfusion fluid to the second interface.

5. The system of claim 1, wherein the module includes a reservoir mounted to the chassis of the module in fluid communication with the organ chamber assembly and sized and shaped for containing perfusion fluid for the heart.

6. The system of claim 1, further comprising a sensor for measuring aortic pressure in the organ care system.

7. The system of claim 1, wherein the processor is configured to calculate the Lactate V-A differential at two different times to correlate a change between the Lactate V-A differentials over time with a suitability of the heart for transplantation.

8. An apparatus comprising:

an organ chamber assembly for containing a heart during perfusion, the organ chamber assembly comprising;

a fluid conduit with a first interface for connecting 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 sense lactate at the first interface;

a Lactate V sensor configured to sense lactate at the second interface;

a processor coupled to the Lactate A sensor and the Lactate V sensor; 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 using lactate values sensed by the Lactate A sensor and the Lactate V sensor.

9. The apparatus of claim 8, wherein the organ chamber assembly is disposable.

10. The apparatus of claim 8, wherein the computer readable instructions cause the processor to calculate the Lactate V-A differential at least once an hour.

11. The apparatus of claim 8, wherein the computer readable instructions cause the processor to calculate the Lactate V-A differential at two different times to correlate a change between the Lactate V-A differentials over time with a suitability of the heart for transplantation.

12. The apparatus of claim 8, further comprising a flow select valve for selecting between flowing the perfusion fluid to the first interface and flowing the perfusion fluid to the second interface.

13. The apparatus of claim 8, further comprising:

a chassis; and

a reservoir mounted to the chassis in fluid communication with the organ chamber assembly and sized and shaped for containing perfusion fluid for the heart.

14. The apparatus of claim 8, further comprising a sensor for measuring aortic pressure in the apparatus.

15. An organ care system for perfusing a heart comprising:

a module including a chassis;

an organ chamber assembly mounted to the chassis for containing a heart during perfusion, the organ chamber assembly 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 sense lactate at the first interface;

a Lactate V sensor configured to sense lactate at the second interface;

a processor coupled to the Lactate A sensor and the Lactate V sensor; 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 lactate values sensed by the Lactate A sensor and the Lactate V sensor; and

correlate a change between the Lactate V-A differentials over time with a suitability of the heart for transplantation.