Granted Patent B2

US 12,396,454 · App. 18/657,537 · Granted Aug 26, 2025

Inventors: Waleed H. Hassanein (North Andover, MA); Tamer I. Khayal (North Andover, MA); Ahmed Elbetanony (North Andover, MA); Paul Lezberg (Westford, MA); Giovanni Cecere (Needham, MA); Dennis Sousa (Wakefield, MA); Elizabeth Hansen Bulger (Portsmouth, NH)

Assignee: TRANSMEDICS, INC.

A01N1/143A01N1/10A01N1/148

Abstract

Claims (57)

1. An organ care system for perfusing a heart, the organ care system comprising:

a chassis;

an organ chamber assembly mounted to the chassis, the organ chamber assembly configured to contain the heart during a perfusion, the organ chamber assembly comprising:

a fluid conduit comprising:

a first interface configured to connect to an aorta of the heart; and

a second interface configured to connect to a pulmonary artery of the heart;

a first lactate sensor configured to measure a first lactate value at the first interface, and

a second lactate sensor configured to measure a second lactate value at the second interface;

an oxygenator;

a reservoir mounted to the chassis, wherein the reservoir is in fluid communication with the organ chamber assembly and is configured to contain a perfusion fluid; and

a processor configured to:

calculate a lactate differential at two different times using the first lactate value and the second lactate value,

wherein the organ care system is configured to receive an adjustment of a flow of the perfusion fluid based on a change between the lactate differential at the two different times.

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

3. The organ care system of claim 1 , wherein the processor is configured to calculate the lactate differential at least once per hour.

4. The organ care system of claim 1 , comprising a flow mode selector valve configured to select between flowing the perfusion fluid to the first interface and flowing the perfusion fluid to the second interface.

5. The organ care system of claim 1 , comprising a pressure sensor configured to measure an aortic pressure.

6. The organ care system of claim 1 , wherein the processor is configured to correlate a change between the lactate differential at the two different times with a suitability of the heart for transplantation.

7. An apparatus comprising:

an organ chamber assembly configured to contain a heart during a perfusion, the organ chamber assembly comprising:

a fluid conduit comprising:

a first interface configured to connect to an aorta of the heart; and

a second interface configured to connect to a pulmonary artery of the heart;

a first lactate sensor configured to measure a first lactate value at the first interface; and

a second sensor configured to measure a second lactate value at the second interface;

an oxygenator;

a reservoir, wherein the reservoir is in fluid communication with the organ chamber assembly and is configured to contain a perfusion fluid;

a processor coupled to the first lactate sensor and to the second lactate sensor; and

a memory coupled to the processor and comprising computer-readable instructions that, when executed by the processor, cause the processor to:

calculate a lactate differential at two different times using the first lactate value and the second lactate value,

wherein the apparatus is configured to receive an adjustment of a flow of the perfusion fluid based on the two or more lactate differentials.

8. The apparatus of claim 7 , wherein the organ chamber assembly is disposable.

9. The apparatus of claim 7 , wherein the computer-readable instructions, when executed by the processor, cause the processor to:

calculate the lactate differential at least once per hour.

10. The apparatus of claim 7 , wherein the computer-readable instructions, when executed by the processor, cause the processor to-correlate a change between the lactate differential at the two different times with a suitability of the heart for transplantation.

11. The apparatus of claim 7 , comprising a flow mode selector valve configured to select between flowing the perfusion fluid to the first interface and flowing the perfusion fluid to the second interface.

12. The apparatus of claim 7 , wherein the reservoir is mounted to a chassis.

13. The apparatus of claim 7 , comprising a pressure sensor configured to measure an aortic pressure.

14. An organ care system comprising:

a chassis;

an organ chamber assembly mounted to the chassis, wherein the organ chamber assembly is configured to contain a heart during a perfusion, the organ chamber assembly comprising:

a fluid conduit comprising:

a first interface configured to connect to an aorta of the heart; and

a second interface configured to connect to a pulmonary artery of the heart;

a first lactate sensor configured to measure a first lactate value at the first interface; and

a second lactate sensor configured to measure a second lactate value at the second interface;

an oxygenator;

a reservoir mounted to the chassis, wherein the reservoir is in fluid communication with the organ chamber assembly and is configured to contain a perfusion fluid;

a processor coupled to the first lactate sensor and to the second lactate sensor; and

a memory coupled to the processor and comprising computer-readable instructions that, when executed by the processor, cause the processor to:

calculate a lactate differential at two different times using the first lactate value and the second lactate value; and

correlate a change between the lactate differential at the two different times with a suitability of the heart for transplantation,

wherein the organ care system is configured to receive an adjustment of a flow of the perfusion fluid based on a change between the lactate differential at the two different times.

15. The organ care system of claim 14 , wherein the organ chamber assembly is disposable.

16. The organ care system of claim 14 , comprising a flow mode selector valve configured to select between flowing the perfusion fluid to the first interface and flowing the perfusion fluid to the second interface.

17. The organ care system of claim 14 , comprising a pressure sensor configured to measure an aortic pressure.

18. The organ care system of claim 14 , wherein the processor is configured to calculate the change between the lactate differential at least once per hour.

Assignments (1)

Continuity (11)

References Cited (400)