Systems and methods for ex-vivo organ care

• US 8,465,970 B2
• Filed: 10/07/2005
• Issued: 06/18/2013
• 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:
  US11/246,902
• Publication Number:
  US 20060154358A1
• Time in Patent Office: 2,811 Days
• Field of Search: 435/1.2, 435/284.1, 435/297.2, 417/378, 417/383, 417/385, 417/387, 417/448, 417/540
• US Class Current: 435/297.2
• 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 pump driver; and

a single use disposable module including

a disposable chassis sized for interlocking the single use module with the multiple use module,

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 the pump driver to the perfusion fluid, and

an organ chamber assembly mounted to the disposable 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 driver separably aligns with the pump interface upon interlocking the single use disposable module with the portable multiple use module,

the organ chamber assembly further comprising axially extending protuberances on the pump interface, the protuberances abutting a surface on the portable multiple use module to move the pump interface toward the pump driver on the multiple use module to form a separable fluid tight seal between the pump interface and the pump driver.

2. The system 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 system of claim 1, wherein the disposable module includes a reservoir for containing the perfusion fluid in-fluid communication with the organ chamber assembly and the perfusion circuit.

4. The system of claim 1, wherein the disposable module includes a flow select valve for selecting between pumping the perfusion fluid to the first conduit and pumping the perfusion fluid to second conduit.

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 containing perfusion fluid for the heart.

6. The system of claim 1, wherein the disposable module includes 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.

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 fluid heater includes at least one heated plate in direct contact with the perfusion fluid.

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

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

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

13. The system of claim 12, wherein the temperature sensor senses the temperature of the perfusion fluid as it exits the fluid heater.

14. The system of claim 12, wherein the temperature sensor senses the temperature of the perfusion fluid as it enters the fluid heater.

15. 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.

16. The system of claim 15 comprising a temperature sensor for sensing temperature of the heater element.

17. 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.

18. The system of claim 1, wherein the disposable module includes an oxygenator in fluid communication with the perfusion circuit for providing the oxygen-containing gas to the perfusion fluid.

19. The system of claim 18, wherein the oxygenator is located on the disposable single use module.

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

21. The system of claim 20, wherein the oxygen level includes an oxygen saturation of the perfusion fluid.

22. The system of claim 20, wherein the sensor measures a hematocrit of the perfusion fluid.

23. The system of claim 22, wherein the sensor is positioned on the disposable single use module to sense the perfusion fluid entering the heart.

24. The system of claim 22, wherein the sensor is positioned on the disposable single use module to sense the perfusion fluid exiting the heart.

25. The system of claim 20, 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.

26. The system of claim 20, wherein the sensor includes a seamless in-line cuvette through which the perfusion fluid passes.

27. The system of claim 1, wherein the disposable module includes a flow rate sensor for sensing a flow rate of the perfusion fluid to the organ chamber assembly.

28. The system of claim 1, wherein the disposable module includes a flow rate sensor for sensing a flow rate of the perfusion fluid from the organ chamber assembly.

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

30. The system of claim 28, wherein the compliance chamber is located between the fluid heater and the first conduit.

31. The system of claim 28, wherein the compliance chamber is located between the fluid heater and the second conduit.

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

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

34. The system of claim 33, wherein the sampling ports are located on the disposable single use module.

35. 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.

36. 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.

37. 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.

38. 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 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.

41. The system of claim 40, wherein the flexible pliant membrane is configured to extend into the organ chamber assembly and to contact a heart contained within the chamber.

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

43. The system of claim 42, wherein the second hinged cover is substantially rigid.

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

45. The system of claim 1, wherein the organ chamber assembly is adapted to maintain an explanted organ at near physiologic temperatures and further includes a pad assembly for supporting a heart, the pad assembly including at least one electrode for providing electrical stimulation to the heart when the explanted heart is at near physiologic temperatures.

46. The system of claim 45, wherein the at least one electrode is sized, shaped and positioned in the pad assembly to provide sutureless interconnection with the heart.

47. 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.

48. The system of claim 45, wherein the at least one sensor is sized, shaped and positioned in the pad assembly to provide sutureless interconnection with the heart.

49. The system of claim 45, wherein the signals include an r-wave for the heart.

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

51. The system 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 third conduit.

52. The system of claim 1 comprising a controller for controlling operation of the pump driver in response to a physiological characteristic of the heart, wherein the pump driver is a pulsatile pump driver and the operation of the pump driver includes timing the flow of perfusion fluid so the perfusion fluid enters the heart when the heart is in a diastolic state.

53. The system of claim 52, 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 driver pumps, and the controller adjusts the stroke volume of the pulsatile pump driver in response to the rate at which the heart is beating.

54. The system of claim 52, wherein the diastolic state is a diastolic state of a ventricle of the heart.

55. The system of claim 54, wherein the ventricle is the a left ventricle.

56. The system of claim 52, wherein the diastolic state is a diastolic state of an atrium of the heart.

57. The system of claim 56, wherein the atrium is a right atrium.

58. The system of claim 52, wherein the pumping characteristic includes a shape of waveform representative of a rate and stroke volume at which the pump driver 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.

59. The system of claim 52, wherein the pumping characteristic includes a flow volume of fluid per unit time at which the pump driver pumps the perfusion fluid, and the controller alters the flow volume in response to the physiologic characteristic of the heart.

60. The system of claim 52, 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.

61. The system of claim 52, 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.

62. The system of claim 52, wherein the physiologic parameter is indicative of pressure.

63. The system of claim 52, wherein the physiologic characteristic includes a fluid flow rate out of the heart.

64. 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.

65. The system of claim 18, wherein the gas supply is an onboard gas supply.

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

39. An organ care system comprising:

portable multiple use module including a portable chassis and a pump driver; and

a single use disposable module including,

a disposable chassis for interlocking the single use module with the multiple use module,

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 the pump driver to the perfusion fluid, and

an organ chamber assembly mounted to the disposable 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 driver separably aligns with the pump interface upon interlocking the single use disposable module with the portable multiple use module and the pump interface mounts to the chassis of the single use module and includes features for interlocking with mating features of the pump driver for forming a separable fluid sealing interconnection with the pump driver

the organ chamber assembly further comprising axially extending protuberances on the pump interface, the protuberances abutting a surface on the portable multiple use module to move the pump interface toward the pump driver on the multiple use module to form a separable fluid tight seal between the pump interface and the pump driver.