Systems and methods for ex-vivo organ care

• US 9,301,519 B2
• Filed: 10/07/2005
• Issued: 04/05/2016
• 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, Bringham, Richard, Cecere, Giovanni, Elbetanony, Ahmed, Fishman, Robert, Goff, Larry, Khayal, Tamer, Kyi, Stanley, Newell, Scott, Ochs, Burt, Sousa, Dennis, Taylor, Ronald, Rourke, Jonathan, Algamil, Hossam, Carpenter, David, Havner, Robert, Menn, Dmitri
• Primary Examiner(s): HOBBS, MICHAEL L
• Application Number:
  US11/246,013
• Publication Number:
  US 20060154357A1
• Time in Patent Office: 3,833 Days
• Field of Search: 435/1.2, 435/284.1
• US Class Current: 1/1
• 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.

Claims

1. A single use disposable module for a heart preservation system, the single use disposable module comprising:

a chassis,

a perfusion circuit for circulating perfusion fluid, said perfusion circuit including a pump interface having a housing in fluid tight interconnection with a surface that is movable with respect to the housing to translate pumping force from a pump driver to the perfusion fluid, and

an organ chamber assembly mounted to the chassis for containing a heart during perfusion, the organ chamber assembly including a first conduit for connecting the perfusion circuit to an aorta of the heart and a second conduit for connecting the perfusion circuit to a pulmonary vein of the heart, wherein the pump interface is mounted to the chassis and separably aligns with the pump driver by at least a first flange projecting from the pump interface that is sized to interlock with a corresponding slot on the pump driver;

and wherein the pump interface includes at least a tapered projection that is sized to interlock with a corresponding bracket on the pump driver to form a fluid tight seal between the pump interface and the pump driver.

2. The single use module of claim 1 wherein the organ chamber assembly includes a third conduit for connecting the perfusion circuit to a pulmonary artery of the heart.

3. The single use module of claim 1 comprising a reservoir for containing the perfusion fluid and in fluid communication with the organ chamber assembly and the perfusion circuit, said reservoir being mounted to the chassis.

4. The single use module of claim 1 comprising a flow select valve for selecting between pumping the perfusion fluid to the first conduit and pumping the perfusion fluid to the second conduit.

5. The single use module of claim 1 comprising a fluid heater for maintaining the perfusion fluid at a temperature between about 32°

C. and about 37°

C. where said perfusion fluid enters the organ chamber assembly.

6. The single use module of claim 5, wherein the fluid heater includes at least one heated plate in direct contact with the perfusion fluid.

7. The single use module of claim 6 including at least one temperature sensor for sensing a temperature of the heated plate.

8. The single use module of claim 5, wherein the fluid heater includes a pair of heated plates between which the perfusion fluid to be heated flows.

9. The single use module of claim 5 comprising a temperature sensor for sensing temperature of the perfusion fluid.

10. The single module of claim 9, wherein the temperature sensor senses the temperature of the perfusion fluid as it exits the fluid heater.

11. The single use module of claim 9, wherein the temperature sensor senses the temperature of the perfusion fluid as it enters the fluid heater.

12. The single use module of claim 5, wherein the fluid heater includes a heating element in contact with a plate, the plate being for direct contact with the perfusion fluid.

13. The single use module of claim 12 comprising a temperature sensor for sensing temperature of the heating element.

14. The single use module of claim 1 comprising an optical interface for communicating with a corresponding optical interface on a multiple use module when interlocked with the multiple use module.

15. The single use module of claim 1 comprising an oxygenator in fluid communication with the perfusion circuit for providing oxygen to the perfusion fluid.

16. The single use module of claim 1 comprising an oxygen sensor for determining an oxygen level in the perfusion fluid.

17. The single use module of claim 16, wherein the oxygen level includes an oxygen saturation level in the perfusion fluid.

18. The single use module of claim 16, wherein the oxygen sensor measures a hematocrit of the perfusion fluid.

19. The single use module of claim 16, wherein the oxygen sensor is positioned to measure the oxygen level of the perfusion fluid entering the heart.

20. The single use module of claim 16, wherein the oxygen sensor is positioned to measure the oxygen level of the perfusion fluid leaving the heart.

21. The single use module of claim 16, wherein the oxygen sensor includes an in-line cuvette through which the perfusion fluid passes, an optical source for directing light at the perfusion fluid passing through the cuvette, and an optical sensor for measuring an optical quality of the perfusion fluid passing through the cuvette.

22. The single use module of claim 16, wherein the oxygen sensor includes a seamless in-line cuvette through which the perfusion fluid passes.

23. The single use module of claim 1 comprising a flow rate sensor for sensing a flow rate of the perfusion fluid entering the organ chamber assembly.

24. The single use module of claim 1 comprising a flow rate sensor for sensing a flow rate of the perfusion fluid leaving the organ chamber assembly.

25. The single use module of claim 5 comprising a compliance chamber located between the fluid heater and the organ chamber assembly, wherein said compliance chamber is in fluid communication with the perfusion circuit.

26. The single use module of claim 25, wherein the compliance chamber is located between the fluid heater and the second conduit.

27. The single use module of claim 25, wherein the compliance chamber is located between the fluid heater and the first conduit.

28. The single use module of claim 5 comprising a compliance chamber located between the pump interface and the fluid heater, wherein said compliance chamber is in fluid communication with the perfusion circuit.

29. The single use module of claim 1 comprising a sampling port for sampling fluids from the organ chamber assembly.

30. The single use module of claim 1 comprising a plurality of ports for sampling fluids from the organ chamber assembly, interlocked such that sampling fluid from a first of the plurality of ports prohibits simultaneously sampling fluids from a second port of the plurality.

31. The single use module of claim 1 comprising one or more processors for collecting information from one or more sensors on the single use module.

32. The single use module of claim 31 comprising an optical interface for providing the information from the one or more sensors to a multiple use module.

33. The single use module of claim 1, wherein the pump interface mounts to the chassis and includes features for interlocking with mating features on a pump driver for forming fluid sealing interconnection between the pump interface and the pump driver.

34. The single use module of claim 1 comprising axially extending protuberances on the pump interface, the protuberances abutting one or more surfaces on a multiple use module to compress the pump interface toward the pump driver such that the pump interface is aligned to receive a pump driver head.

35. The single use module of claim 1, wherein the organ chamber assembly includes a first hinged cover for covering the organ chamber assembly, the first hinged cover including an outer frame and a flexible pliant membrane disposed on the outer frame.

36. The single use module of claim 35, wherein the flexible pliant membrane is sized and shaped for extending into the organ chamber assembly.

37. The single use module of claim 1, wherein the organ chamber assembly includes a second hinged cover for covering the first hinged cover.

38. The single use module of claim 37, wherein the second hinged cover is substantially rigid.

39. The single use module of claim 1, wherein the organ chamber assembly includes a pad assembly for supporting the heart, the pad assembly including at least one electrode for providing electrical stimulation to the heart.

40. The single use module of claim 39, wherein the at least one electrode is sized, shaped and positioned on the pad assembly to provide sutureless interconnection with the heart.

41. The single use module of claim 1, wherein the organ chamber assembly includes a pad assembly for supporting a heart the pad assembly including at least one sensor for monitoring electrical signals from the heart.

42. The single use module of claim 41, wherein the at least one sensor is sized, shaped and positioned in the pad assembly to provide sutureless interconnection with the heart.

43. The single use module of claim 41, wherein the signals include an r-wave for the heart.

44. The single use module of claim 1, wherein the organ chamber assembly includes a resealable membrane for automatically resealing subsequent to being pierced.

45. The single use module of claim 2, wherein the perfusion circuit includes a bypass tube for providing a three way connection between the first conduit, the second-conduit, and the third conduit.

46. The single use module of claim 4 comprising a trickle line for providing a small flow of perfusion fluid to the first conduit when the second conduit is selected on the flow select valve.

47. The single use module of claim 1 comprising an infusion port for injecting chemical solutions into the perfusion fluid.

50. The single use module of claim 1, including a circuit board and an electromechanical connector protruding from the circuit board, said electromechanical connector being capable of providing an electrical interconnection between the circuit board and an interface circuit board.

51. The single use module of claim 50, wherein the electromechanical connector is a substantially straight and rigid pin.

52. The single use module of claim 51, wherein the substantially straight and rigid pin can move axially in and out.

53. The single use module of claim 52, wherein the substantially straight and rigid pin includes a spring.

54. The single use module of claim 52, wherein the substantially straight and rigid pin includes a spring loaded end.

48. A single use module for a heart preservation system, the single use module comprising,

a chassis,

a perfusion circuit for circulating perfusion fluid, said perfusion circuit including a pump interface having a housing in fluid tight interconnection with a surface that is movable with respect to the housing to translate pumping force from a pump driver to the perfusion fluid, and

an organ chamber assembly mounted to the chassis for containing a heart during perfusion, the organ chamber assembly including an aorta conduit for connecting the perfusion circuit to an aorta of the heart and a pulmonary vein conduit for connecting the perfusion circuit to a pulmonary vein of the heart,

a reservoir mounted to the chassis, said reservoir being in fluid communication with the organ chamber assembly and the perfusion circuit for containing perfusion fluid for the heart,

a heater for maintaining the perfusion fluid at a temperature between about 32°

C. and about 37°

C. where said perfusion fluid enters the organ chamber assembly

wherein the pump interface is mounted to the chassis and separably aligns with the pump driver by at least a first flange projecting from the pump interface that is sized to interlock with a corresponding slot on the pump driver.

49. A single use smart module for a heart preservation system, the single use module comprising,

a chassis,

a perfusion circuit for circulating perfusion fluid, said perfusion circuit including a pump interface having a housing in fluid tight interconnection with a surface that is movable with respect to the housing to translate pumping force from a pump driver to the perfusion fluid, and

an organ chamber assembly mounted to the chassis for containing a heart during perfusion, the organ chamber assembly including an aorta conduit for connecting the independent perfusion circuit to an aorta of the heart and a pulmonary vein conduit for connecting the independent perfusion circuit to a pulmonary vein of the heart,

a reservoir mounted to the chassis, said reservoir being in fluid communication with the organ chamber assembly and the perfusion circuit for containing perfusion fluid for the heart,

a processor for monitoring and controlling, at least in part, operation of the perfusion circuit, organ chamber assembly, reservoir, and pump interface,

wherein the pump interface is mounted to the chassis and includes an interlocking connection that separably aligns with a corresponding interlocking connection on the pump driver to form a fluid tight seal between the pump interface and the pump driver.

55. A single use disposable module for a heart preservation system, the single use disposable module comprising:

a chassis,

a perfusion circuit for circulating perfusion fluid,

an organ chamber assembly mounted to the chassis for containing a heart during perfusion, the organ chamber assembly including a first conduit for connecting the perfusion circuit to an aorta of the heart and a second conduit for connecting the perfusion circuit to a pulmonary vein of the heart, and

a pump interface mounted to the chassis, said pump interface consisting essentially of a an inlet, an outlet, and a housing including at least a tapered projection that is sized to interlock with a corresponding bracket to form a fluid tight interconnection with a surface that is movable with respect to the housing.

56. The single use disposable module of claim 55, including a circuit board and an electromechanical connector protruding from the circuit board, said electromechanical connector being capable of providing an electrical interconnection between the circuit board and an interface circuit board.

57. The single use module of claim 56, wherein the electromechanical connector is a substantially straight and rigid pin.

58. The single use module of claim 57, wherein the substantially straight and rigid pin can move axially in and out.

59. The single use module of claim 58, wherein the substantially straight and rigid pin includes a spring.

60. The single use module of claim 58, wherein the substantially straight and rigid pin includes a spring loaded end.

61. The single use module of claim 57, wherein the electromechanical connector is a rigid pin that includes a spring, whereby said rigid pin contacts a head of the interface circuit board.

62. A single use disposable module for use with a multiple use module of a heart preservation system, the single use disposable module comprising:

a chassis,

a perfusion circuit for circulating perfusion fluid,

an organ chamber assembly mounted to the chassis for containing a heart during perfusion, the organ chamber assembly including a first conduit for connecting the perfusion circuit to an aorta of the heart and a second conduit for connecting the perfusion circuit to a pulmonary vein of the heart,

a circuit board, and

an electromechanical connector protruding from the circuit board that is configured to move axially with respect to the circuit board, said electromechanical connector being capable of providing an electrical interconnection between the circuit board and an electromechanical contact on an interface circuit board in the multiple use module.

63. The single use module of claim 62, wherein the electromechanical connector is a substantially straight and rigid pin.

64. The single use module of claim 63, wherein the substantially straight and rigid pin includes a spring.

65. The single use module of claim 63, wherein the substantially straight and rigid pin includes a spring loaded end.