IP Library Granted Patent US 11,723,357
Granted Patent B2
US 11,723,357 · App. 17/530,037 · Granted Aug 15, 2023

Systems and methods for ex-vivo organ care

Inventors: Waleed H. Hassanein (North Andover, MA); Richard Bringham (North Andover, MA); Giovanni Cecere (Needham, MA); Tamer I. Khayal (North Andover, MA); Ronald Taylor, Jr. (Chester, NH); Hossam Algamil (Scranton, PA)
Assignee: TRANSMEDICS, INC.
A01N1/0242A01N1/02A01N1/0226A01N1/0247
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Quick Facts
Patent No.
US 11,723,357
App. No.
17/530,037
Granted
Aug 15, 2023
Kind
B2
Abstract

The disclosure provides, in various embodiments, systems, devices and methods relating to ex-vivo organ care. In certain embodiments, the disclosure relates to maintaining an organ ex-vivo at near physiologic conditions. In certain embodiments, the disclosure relates to testing properties of an ex-vivo heart or an organ care system, adjusting a property of the organ care system in response to certain results of the testing, and re-testing the ex-vivo heart or the organ care system. In certain embodiments, the disclosure relates to synchronizing at least one cycle of a pumping of a perfusion fluid with a state of the ex-vivo heart.

Claims (59)

1. A method comprising:

placing an ex-vivo heart in a chamber of an organ care system;

connecting the ex-vivo heart to a perfusion fluid circuit of the organ care system;

opening an outer lid of the chamber of the organ care system;

examining the ex-vivo heart through a flexible membrane of the organ care system;

initiating a pumping, via the perfusion fluid circuit, of a perfusion fluid to the ex-vivo heart;

synchronizing at least one cycle of the pumping of the perfusion fluid with an r-wave of the ex-vivo heart;

testing the ex-vivo heart or the organ care system;

adjusting a property of the organ care system in response to a result of the testing ef the ex-vivo heart or the organ care system; and

after adjusting the property of the organ care system in response to the result of the testing the ex-vivo heart or the organ care system, re-testing the ex-vivo heart or the organ care system.

2. The method of claim 1 , wherein testing the ex-vivo heart comprises performing, on the ex-vivo heart, a pressure volume loop evaluation.

3. The method of claim 1 , wherein adjusting the property of the organ care system comprises selecting the property of the organ care system from the group consisting of a fluid-flow rate of the perfusion fluid, a pressure of the perfusion fluid, or a temperature of the perfusion fluid.

4. The method of claim 1 , wherein adjusting the property of the organ care system comprises applying, via one or more electrodes positioned between the ex-vivo heart and a pad in the organ care system, a defibrillation signal to the ex-vivo heart.

5. The method of claim 1 , comprising:

after re-testing the ex-vivo heart or the organ care system, evaluating the ex-vivo heart for a compatibility with an intended recipient.

6. The method of claim 5 , wherein evaluating the ex-vivo heart for the compatibility with the intended recipient comprises performing, while the ex-vivo heart is connected to the organ care system, a Human Leukocyte Antigen (HLA) matching test on the ex-vivo heart.

7. The method of claim 1 , comprising:

performing, while the ex-vivo heart is connected to the organ care system, a surgical procedure on the ex-vivo heart.

8. The method of claim 1 , comprising:

providing, to the ex-vivo heart, an immunosuppressive treatment, a chemotherapy treatment, a genetic therapy, or an irradiation therapy.

9. The method of claim 1 , comprising:

allowing the ex-vivo heart to remain connected to the perfusion fluid circuit for at least three days.

10. The method of claim 1 , comprising:

after adjusting the property of the organ care system in response to the result of the testing, initiating a pumping of the perfusion fluid in a retrograde flow direction.

11. The method of claim 1 , comprising:

slowing or stopping a retrograde flow of the perfusion fluid; and

after slowing or stopping the retrograde flow of the perfusion fluid, initiating a pumping of the perfusion fluid in a forward direction.

12. The method of claim 11 , wherein initiating the pumping of the perfusion fluid in the forward direction comprises initiating the pumping of the perfusion fluid in the forward direction at a flow rate between about 1 Liter/minute and about 5 Liters/minute.

13. The method of claim 1 , wherein synchronizing at least one cycle of the pumping with the r-wave of the ex-vivo heart comprises timing the pumping such that the perfusion fluid enters the ex-vivo heart when the ex-vivo heart is in a diastolic state.

14. The method of claim 13 , further comprising timing the pumping such that a maximum pump output occurs when the ex-vivo heart is in the diastolic state.

15. The method of claim 1 , wherein:

the pumping occurs in a retrograde flow direction; and

synchronizing at least one cycle of the pumping with the r-wave of the ex-vivo heart comprises initiating a pump cycle at a peak of the r-wave of the ex-vivo heart.

16. The method of claim 1 , wherein:

the pumping occurs in a forward flow direction; and

synchronizing at least one cycle of the pumping with the r-wave of the ex-vivo heart comprises initiating a pump cycle at an offset of the r-wave of the ex-vivo heart.

17. The method of claim 1 , wherein testing the ex-vivo heart comprises performing, on the ex-vivo heart, a blood chemistry analysis.

18. The method of claim 1 , wherein the property of the organ care system is an oxygenation level of the perfusion fluid.

19. The method of claim 1 , wherein the property of the organ care system is a nutrition level of the perfusion fluid.

20. A method comprising:

receiving an ex-vivo heart in a chamber of an organ care system;

opening an outer lid of the chamber of the organ care system;

examining the ex-vivo heart through a flexible membrane of the organ care system;

pumping, via a perfusion fluid circuit of the organ care system, a perfusion fluid to the ex-vivo heart,

synchronizing at least one cycle of the pumping of the perfusion fluid to the ex-vivo heart with an r-wave of the ex-vivo heart;

allowing for testing of the ex-vivo heart or the organ care system;

receiving an adjustment of a property of the organ care system in response to a result of the testing of the ex-vivo heart or the organ care system; and

after receiving the adjustment of the property of the organ care system in response to the result of the testing of the ex-vivo heart or the organ care system, allowing for re-testing of the ex-vivo heart or the organ care system.

21. The method of claim 20 , wherein allowing for testing of the ex-vivo heart or the organ care system comprises allowing for measuring, with respect to the ex-vivo heart, an arterial blood gas level.

22. The method of claim 20 , wherein receiving the adjustment of the property of the organ care system comprises receiving, via one or more electrodes positioned between the ex-vivo heart and a pad in the organ care system, an application of a defibrillation signal to the ex-vivo heart.

23. The method of claim 20 , comprising:

after receiving the adjustment of the property of the organ care system in response to the result of the testing, pumping the perfusion fluid in a retrograde flow direction.

24. The method of claim 20 , comprising:

slowing or stopping a retrograde flow of the perfusion fluid; and

after slowing or stopping the retrograde flow of the perfusion fluid, pumping the perfusion fluid in a forward direction.

25. The method of claim 24 , wherein pumping the perfusion fluid in the forward direction comprises pumping the perfusion fluid in the forward direction at a flow rate between about 1 Liter/minute and about 5 Liters/minute.

26. The method of claim 20 , wherein synchronizing at least one cycle of the pumping with the r-wave of the ex-vivo heart comprises timing the pumping such that the perfusion fluid enters the ex-vivo heart when the ex-vivo heart is in a diastolic state.

27. The method of claim 26 , further comprising timing the pumping such that a maximum pump output occurs when the ex-vivo heart is in the diastolic state.

28. The method of claim 20 , wherein allowing for testing of the ex-vivo heart or the organ care system comprises allowing for measuring, with respect to the ex-vivo heart, a metabolite level.

Assignments (4)
SECURITY INTEREST Recorded Jul 29, 2022
From: TRANSMEDICS, INC.
To: CANADIAN IMPERIAL BANK OF COMMERCE
Reel/Frame 060677/0520 →
CORRECTIVE ASSIGNMENT TO CORRECT THE TYPOGRAPHICAL ERROR IN INVENTOR ALGAMIL'S NAME PREVIOUSLY RECORDED AT REEL: 058342 FRAME: 0627. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Dec 17, 2021
From: HASSANEIN, WALEED; BRINGHAM, RICHARD; CECERE, GIOVANNI; KHAYAL, TAMER; TAYLOR, RONALD, JR; ALGAMIL, HOSSAM
To: TRANSMEDICS, INC.
Reel/Frame 058535/0753 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 9, 2021
From: HASSANEIN, WALEED; BRINGHAM, RICHARD; CECERE, GIOVANNI; KHAYAL, TAMER; TAYLOR, RONALD, JR; ALGAMIL, HASSAM
To: TRANSMEDICS, INC.
Reel/Frame 058342/0627 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 9, 2021
From: ALGAMIL, HOSSAM
To: TRANSMEDICS, INC.
Reel/Frame 058342/0651 →
Cited By (2)
US 12,317,888 US 12,396,454