Systems and methods for ex-vivo organ care

• US 9,055,740 B2
• Filed: 10/07/2005
• Issued: 06/16/2015
• 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, Fishman, Robert, Kyi, Stanley, Newell, Scott, Ochs, Burt, Rourke, Jonathan, Havner, Robert
• Primary Examiner(s): Marcheschi, Michael
• Assistant Examiner(s): Doe, Shanta G
• Application Number:
  US11/246,903
• Publication Number:
  US 20060154359A1
• Time in Patent Office: 3,539 Days
• Field of Search: 435/284.1, 435/303.1, 435/1.1, 435/1.2, 435/297.1, 435/286.5, 435/286.6, 435/307.1, 435/809, 392/470, 604/113, 165/168, 165/170, 165/171, 165/172, 165/173, 165/176, 165/175, 165/177, 165/178, 165/181
• US Class Current: 1/1
• CPC Class Codes: A01N 1/02 Preservation of living parts
• CPC Class Codes: A01N 1/0226 Physiologically active agents, i.e. substances affecting physiological processes of cells and tissue to be preserved, e.g. anti-oxidants or nutrients
• CPC Class Codes: A01N 1/0242 Apparatuses, i.e. devices used in the process of preservation of living parts, such as pumps, refrigeration devices or any other devices featuring moving parts and/or temperature controlling components
• 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 and devices relating to a blood product heater for use in an ex-vivo organ care. In certain embodiments, the invention relates to maintaining a perfusion fluid flowing through the heater at near-physiologic conditions.

Claims

1. A blood product heater for use in an organ care system, the blood product heater comprising,

a heater inlet, a channel and a heater outlet,

said heater inlet for flowing a blood product into the blood product heater, said heater inlet comprising a tube having an inside cross-sectional area and an inside cross-sectional shape;

said heater outlet for flowing the blood product out of the blood product heater, said heater outlet comprising a tube having an inside cross-sectional area and an inside cross-sectional shape;

said channel having an inside cross-sectional area and an inside cross-sectional shape and extending between the heater inlet and the heater outlet and formed between first and second flow channel plates,

said channel having substantially bioinert blood product contacting surfaces for providing direct contact with the blood product flowing through the channel, and

wherein the inside cross-sectional area of the channel is substantially equal to the inside cross-sectional area of at least one of said inlet and outlet;

wherein the inside cross-sectional shape of the channel differs from the inside cross-sectional shape of the at least one of said inlet and outlet;

wherein the substantially equal inside cross-sectional area of the channel and the at least one of said inlet and outlet minimizes the disturbance of blood product flow through the blood product heater; and

a first heater thermally coupled to the first flow channel plate for heating the first flow channel plate.

2. The blood product heater of claim 1 comprising a second heater thermally coupled to the second flow channel plate for heating the second flow channel plate.

3. The blood product heater of claim 2 comprising a first heater plate disposed between the first heater and the first flow channel plate for coupling heat from the first heater to the first flow channel plate.

4. The blood product heater of claim 3 comprising a second heater plate disposed between the second heater and the second flow channel plate for coupling heat from the second heater to the second flow channel plate.

5. The blood product heater of claim 4 comprising a blood product temperature sensor for providing an electrical signal indicative of temperature of the blood product near the outlet of the blood product heater.

6. The blood product heater of claim 4 comprising a first heater temperature sensor for providing an electrical signal indicative of a temperature of the first heater.

7. The blood product heater of claim 6 comprising a second heater temperature sensor for providing an electrical signal indicative of a temperature of the second heater.

8. The blood product heater of claim 1 comprising a blood product temperature sensor for providing an electrical signal indicative of temperature of the blood product near the outlet of the blood product heater.

9. The blood product heater of claim 1 comprising a first plate temperature sensor for providing an electrical signal indicative of a temperature of the first flow channel plate.

10. The blood product heater of claim 1 comprising a first heater plate disposed between the first heater and the first flow channel plate for coupling heat from the first heater to the first flow channel plate.

11. The blood product heater of claim 10, wherein the first heater plate is formed from aluminum.

12. The blood product heater of claim 10 comprising a first resilient pad disposed on the first heater for maintaining the first heater in contact with the first heater plate in response to compressive force.

14. The blood product heater of claim 1, wherein the first heater uses up to about 200 Watts of power.

15. The blood product heater of claim 1, wherein the blood product heater is sized and shaped to transition blood flowing through the channel at a rate of between about 300 ml/min and about 5 liter/min from a temperature of less than about 30°

C. to a temperature of at least about 37°

C. in between about 15 min and about 25 min, without causing substantial hemolysis.

16. The blood product heater of claim 1, wherein the blood product heater is sized and shaped to transition blood flowing through the channel at a rate of between about 300 ml/min and about 5 liter/min from a temperature of less than about 30°

C. to a temperature of at least about 37°

C. in between about 15 min and about 25 min, without causing denaturing of proteins.

17. The blood product heater of claim 1, wherein the blood product heater is a single use disposable assembly.

18. The blood product heater of claim 1, wherein the blood product heater is formed at least in part from a polycarbonate.

19. The blood product heater of claim 1, wherein the blood product heater weights less than about 5 lbs.

20. The blood product heater of claim 1, wherein the blood product heater weights less than about 4 lbs.

21. The blood product heater of claim 1, wherein the blood product heater weights less than about 3 lbs.

22. The blood product heater of claim 1, wherein the blood product heater weights less than about 2 lbs.

23. The blood product heater of claim 1, wherein the blood product heater weights less than about 1 lb.

48. The blood product heater of claim 1, wherein the channel has a length, height and a width, in which the width is larger than the height and the length is larger than the width.

13. A blood product heater for use in an organ care system, the blood product heater comprising,

a heater inlet, a channel and a heater outlet,

said heater inlet having an inside cross-sectional area and an inside cross-sectional shape for flowing a blood product into the blood product heater,

said heater outlet having an inside cross-sectional area and an inside cross-sectional shape for flowing the blood product out of the blood product heater;

said channel having an inside cross-sectional area and an inside cross-sectional shape and extending between the heater inlet and the heater outlet and formed between first and second flow channel plates having substantially bioinert blood product contacting surfaces for providing direct contact with the blood product flowing through the channel, wherein the inside cross-sectional shape of the channel differs from the inside cross-sectional shape of the at least one of said inlet and outlet;

wherein the inside cross-sectional area of the channel and the at least one of said inlet and outlet are substantially equal, to minimize the disturbance of blood product flow through the blood product heater; and

a first heater thermally coupled to the first flow channel plate for heating the first flow channel plate;

wherein the blood contacting surfaces of the first and second flow channel plates are formed from titanium.

24. A blood product heater for use in an organ care system, the blood product heater comprising,

a heater inlet, a channel and a heater outlet,

said heater inlet having an inside cross-sectional area and an inside cross-sectional shape for flowing a blood product into the blood product heater,

said heater outlet having an inside cross-sectional area and an inside cross-sectional shape for flowing the blood product out of the blood product heater,

said channel having an inside cross-sectional area and an inside cross-sectional shape and extending between the heater inlet and the heater outlet and formed between first and second flow channel plates having substantially bioinert blood product contacting surfaces for providing direct contact with the blood product flowing through the channel and an inside cross-sectional area that is substantially equal to the inside cross sectional area of at least one of said inlet and outlet;

wherein the inside cross-sectional shape of the channel differs from the inside cross-sectional shape of the at least one of said inlet and outlet;

wherein the substantially equal inside cross-sectional area of the channel and the at least one of said inlet and outlet minimizes the disturbance of blood product flow through the blood product heater;

a first heater thermally coupled to the first flow channel plate for heating the first flow channel plate; and

a pump for circulating heated blood product to an organ being preserved.

25. The blood product heater of claim 24 comprising a second heater thermally coupled to the second flow channel plate for heating the second flow channel plate to a temperature of up to about 44°

C.

26. The blood product heater of claim 25, wherein the blood product heater includes a first heater plate disposed between the first heater and the first flow channel plate for coupling heat from the first heater to the first flow channel plate.

27. The blood product heater of claim 26, wherein the blood product heater includes a second heater plate disposed between the second heater and the second flow channel plate for coupling heat from the second heater to the second flow channel plate.

28. The blood product heater of claim 27, wherein the blood product heater includes a blood product temperature sensor for providing an electrical signal indicative of temperature of the blood product near the outlet of the blood product heater.

29. The blood product heater of claim 27, wherein the blood product heater includes a first heater temperature sensor for providing an electrical signal indicative of a temperature of the first heater.

30. The blood product heater of claim 29, wherein the blood product heater includes a second heater temperature sensor for providing an electrical signal indicative of a temperature of the second heater.

31. The blood product heater of claim 24, wherein the blood product heater includes a blood product temperature sensor for providing an electrical signal indicative of temperature of the blood product near the outlet of the blood product heater.

32. The blood product heater of claim 24, wherein the blood product heater includes a first heater temperature sensor for providing an electrical signal indicative of a temperature of the first heater.

33. The blood product heater of claim 24, wherein the blood product heater includes a first heater plate disposed between the first heater and the first flow channel plate for coupling heat from the first heater to the first flow channel plate.

34. The blood product heater of claim 33, wherein the first heater plate is formed from aluminum.

35. The blood product heater of claim 33, wherein the blood product heater includes a first resilient pad disposed on the first heater for maintaining the first heater in contact with the first heater plate in response to compressive force.

36. The blood product heater of claim 25, wherein the blood contacting surfaces of the first and second flow channel plates are formed from titanium.

37. The blood product heater of claim 24, wherein the first heater uses up to about 200 Watts of power.

38. The blood product heater of claim 24, wherein the blood product heater is sized and shaped to transition blood flowing through the channel at a rate of between about 300 ml/min and about 5 liter/min from a temperature of less than about 30°

C. to a temperature of at least about 37°

C. in between about 15 min and about 25 min, without causing substantial hemolysis.

39. The blood product heater of claim 24, wherein the blood product heater is sized and shaped to transition blood flowing through the channel at a rate of between about 300 ml/min and about 5 liter/min from a temperature of less than about 30°

C. to a temperature of at least about 37°

C. in between about 15 min and about 25 min, without causing substantial hemolysis denaturing of proteins.

40. The blood product heater of claim 24, wherein the blood product heater is a single use disposable assembly.

41. The blood product heater of claim 24, wherein the blood product heater is formed at least in part from a polycarbonate.

42. The blood product heater of claim 24, wherein the blood product heater weights less than about 5 lbs.

43. The blood product heater of claim 24, wherein the blood product heater weights less than about 4 lbs.

44. The blood product heater of claim 24, wherein the blood product heater weights less than about 3 lbs.

45. The blood product heater of claim 24, wherein the blood product heater weights less than about 2 lbs.

46. The blood product heater of claim 24, wherein the blood product heater weights less than about 1 lbs.

47. The blood product heater of claim 24 comprising conduits for circulating the blood product, wherein the conduits have an inside cross-sectional area substantially equal to a cross-sectional area of the channel of the blood product heater.

49. The blood product heater of claim 24, wherein the channel has a length, height and a width, in which the width is larger than the height and the length is larger than the width.