Systems and methods for ex-vivo organ care

• US 20060154358A1
• Filed: 10/07/2005
• Published: 07/13/2006
• Est. Priority Date: 10/07/2004
• Status: Active Grant

• Current Assignee: TransMedics, Inc. (TransMedics Group, Inc.)
• Original Assignee: TransMedics, Inc. (TransMedics Group, Inc.)
• Inventors: Sousa, Dennis, Menn, Dmitri, Kyi, Stanley, Hassanein, Waleed, Khayal, Tamer, Newell, Scott, Carpenter, David, Taylor, Ronald, Goff, Larry, Bringham, Richard, Fishman, Robert, Cecere, Giovanni, Ochs, Burt, Havner, Robert, Algamil, Hossam, Elbetanony, Ahmed, Rourke, Jonathan
• Granted Patent: US 8,465,970 B2
• Time in Patent Office: Days
• US Class Current: 435/284.100
• 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, 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. An organ care system comprising:

a portable multiple use module including a portable chassis; and

a single use disposable module including,

a disposable chassis sized and shaped for interlocking the single use module with the multiple use module for electromechanical interoperation with the multiple use module,

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

a pump interface for receiving a pumping force from a pump and for translating the pumping force to a perfusion fluid to pump the perfusion fluid to the organ chamber assembly.

2. The system of claim 1 comprising a third interface for connecting to a pulmonary artery of the heart.

3. The system of claim 1 comprising a reservoir for containing the perfusion fluid in-fluid communication with the organ chamber assembly.

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

5. The system of claim 1, wherein the disposable single use module includes a reservoir mounted to the chassis of the disposable single use 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 comprising a fluid heater for maintaining at least the perfusion fluid provided to the organ chamber assembly at a temperature between about 32°

C. and about 37°

C.

7. The system of claim 6, wherein the heater is a solid state heater.

8. The system of claim 6, wherein the heater is located in the disposable single use module.

9. The system of claim 6, wherein the heater is located in the portable multiple use module.

10. The system of claim 6, wherein the fluid heater includes at least one heated plate in direct contact with the perfusion fluid.

11. The system of claim 6 including at least one temperature sensor for sensing a temperature of the heated plate.

12. The system of claim 6, wherein the fluid heater includes a pair of heated plates between which the perfusion fluid to be heated flows.

13. The system of claim 6 comprising a temperature sensor for sensing temperature of the perfusion fluid.

14. The system of claim 13, wherein the temperature sensor senses the temperature of the perfusion fluid as it exits the fluid heater.

15. The system of claim 13, wherein the temperature sensor senses the temperature of the perfusion fluid as it enters the fluid heater.

16. The system of claim 6, wherein the fluid heater includes a heating element in contact with a plate, the plate being for direct contact with the perfusion fluid.

17. The system of claim 16 comprising a temperature sensor for sensing temperature of the heater element.

18. The system of claim 1, wherein the portable multiple use module includes an optical interface and the disposable single module includes a corresponding optical interface for transfer of information between the portable multiple use module and the disposable single use module.

19. The system of claim 1 comprising an oxygenator in fluid communication with an oxygen-containing gas supply for providing the oxygen-containing gas to the perfusion fluid.

20. The system of claim 19, wherein the oxygenator is located on the disposable single use module.

21. The system of claim 1 comprising a sensor for determining an oxygen level in the perfusion fluid.

22. The system of claim 1, wherein the oxygen level includes an oxygen saturation of the perfusion fluid.

23. The system of claim 21, wherein the sensor measures a hematocrit of the perfusion fluid.

24. The system of claim 23, wherein the sensor is positioned on the disposable single use module to sense the perfusion fluid entering the heart.

25. The system of claim 23, wherein the sensor is positioned on the disposable single use module to sense the perfusion fluid exiting the heart.

26. The system of claim 21, wherein the 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.

27. The system of claim 21, wherein the sensor includes a seamless in-line cuvette through which the perfusion fluid passes.

28. The system of claim 1 comprising a flow rate sensor for sensing a flow rate of the perfusion fluid to the organ chamber assembly.

29. The system of claim 1 comprising a flow rate sensor for sensing a flow rate of the perfusion fluid from the organ chamber assembly.

30. The system of claim 6 comprising a compliance chamber located between the fluid heater and the organ chamber assembly.

31. The system of claim 29, wherein the compliance chamber is located between the fluid heater and the first interface.

32. The system of claim 29, wherein the compliance chamber is located between the fluid heater and the second interface.

33. The system of claim 6 comprising a compliance chamber located between the pump interface and the fluid heater.

34. The system of claim 1 comprising a sampling port for sampling fluids from the organ chamber assembly.

35. The system of claim 34, wherein the sampling ports are located on the disposable single use module.

36. The system 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.

37. The system of claim 1 comprising at least one processor for collecting information from one or more sensors on the disposable module, and for providing the information to a user interface.

38. The system of claim 1 comprising at least one processor, located on the multiple use module for controlling, at least in part, operation of the disposable single use module.

39. The system of claim 1 including at least one processor for collecting information from one or more sensors, for identifying operating abnormalities and for communicating the operation abnormalities to the portable multiple use module.

40. The system of claim 1, wherein the pump interface mounts to the chassis of the single use module and includes features for fluid sealing interconnection with mating features on a pump on the multiple use module in response to interlocking the single use and multiple use modules.

41. The system of claim 1 comprising axially extending protuberances on the pump interface, the protuberances sized and shaped to abut a surface on the portable multiple use module during the interlocking between the multiple use module and the single use module to exert a compressing force between the pump interface and a pump on the multiple use module to form a fluid tight seal between the pump interface and the pump.

42. The system of claim 1, wherein the pump interface includes a flexible membrane for isolating the perfusion fluid from the pump driver.

43. The system 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.

44. The system of claim 43, wherein the flexible pliant membrane is sized and shaped for extending into the organ chamber assembly.

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

46. The system of claim 45, wherein the second hinged cover is substantially rigid.

47. The system of claim 3, wherein the organ chamber assembly includes apertures through which the first second and third interfaces pass.

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

49. The system of claim 48, wherein the at least one electrode is sized, shaped and positioned in the pad assembly to provide sutureless interconnection with the heart.

50. The system 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.

51. The system of claim 48, wherein the at least one sensor is sized, shaped and positioned in the pad assembly to provide sutureless interconnection with the heart.

52. The system of claim 48, wherein the signals include an r-wave for the heart.

53. The system of claim 1, wherein the organ chamber assembly includes a resealable membrane for automatically resealing subsequent to being pierced.

54. The system of claim 2, wherein the organ chamber assembly includes a bypass tube for transferring the perfusion fluid across an inside of the chamber assembly between the first interface and the third interface and between the second interface and third interface.

55. The system of claim 1 comprising a pulsatile pump and a controller for controlling a pumping characteristic of the pulsatile pump based at least in part on a monitored physiologic characteristic from a heart contained in the organ chamber assembly.

56. The system of claim 55, wherein the physiologic characteristics includes a rate at which the heart is beating, the pumping characteristic includes a stroke volume at which the pulsatile pump pumps, and the controller adjusts the stroke volume of the pulsatile pump in response to the rate at which the heart is beating.

57. The system of claim 55, wherein the pumping characteristic includes a time at which the pump pumps the perfusion fluid into the heart, the physiologic characteristic includes a representation of a portion of the heart being in a diastolic state, and the controller pumps the perfusion fluid to the heart during the diastolic state of the portion of the heart.

58. The system of claim 57, wherein the diastolic state is a diastolic state of a ventricle of the heart.

59. The system of claim 58, wherein the ventricle is the a left ventricle.

60. The system of claim 57, wherein the diastolic state is a diastolic state of an atrium of the heart.

61. The system of claim 60, wherein the atrium is a right atrium.

62. The system of claim 55, wherein the pumping characteristic includes a shape of waveform representative of a rate and stroke volume at which a pump pumps the perfusion fluid to the heart, and the controller alters the shape of the waveform in response to the physiologic characteristic of the heart.

63. The system of claim 55, wherein the pumping characteristic includes a flow volume of fluid per unit time at which the pump pumps the perfusion fluid, and the controller alters the flow volume in response to the physiologic characteristic of the heart.

64. The system of claim 55, wherein the physiologic characteristic include an r-wave from the heart and the controller synchronizes the pumping of the perfusion fluid with the r-wave.

65. The system of claim 55, wherein the physiologic characteristic includes an r-wave from the heart and the method includes synchronizing pumping of the perfusion fluid with the r-wave, adjusted by a user selectable pumping delay.

66. The system of claim 55, wherein the physiologic parameter is indicative of pressure.

67. The system of claim 55, wherein the physiologic characteristic includes a fluid flow rate out of the heart.

68. The system of claim 1 including a fault tolerant battery system including a plurality of batteries interlocked such that all of the plurality of batteries may not be removed from the system at least while the system is operating.

69. The system of claim 19, wherein the gas supply is an onboard gas supply.

70. The system of claim 1 including a wireless user interface for providing information to and receiving commands from an operator.