Apparatus and method for maintaining and/or restoring viability of organs

• US 6,673,594 B1
• Filed: 08/25/2000
• Issued: 01/06/2004
• Est. Priority Date: 09/29/1998
• Status: Expired due to Term

• Current Assignee: Lifeline Scientific, Inc. (Shanghai Genext Medical Technology Co., Ltd.)
• Original Assignee: Organ Recovery Systems, Inc. (Shanghai Genext Medical Technology Co., Ltd.)
• Inventors: Kravitz, David C., Schein, Douglas, Burroughs, Andrew, Owen, Donald R., Fraser, Richard, Brassil, John, Harris, Stanley, Brockbank, Kelvin G. M., Steibel, Dennis, Isaacs, Dickon
• Primary Examiner(s): Beisner, William H.
• Application Number:
  US09/645,525
• Time in Patent Office: 1,229 Days
• Field of Search: 435/284.1, 435/809, 435/1.2, 435/286.6, 435/286.5, 435/307.1
• US Class Current: 435/284.1
• 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
• CPC Class Codes: A01N 1/0273 Transport containers A01N1/0268 takes precedence

Abstract

An organ perfusion apparatus and method monitor, sustain and/or restore viability of the organs and preserve organs for storage and/or transport. Other apparatus include an organ transporter, an organ cassette and an organ diagnostic device.

Claims

1. Apparatus for holding an organ for at least one of perfusion, storage, diagnosis and transport of the organ, comprising:

a portable housing;

a first lid;

a second lid interior to said first lid;

an organ supporting surface configured to support an organ within said housing, wherein the portable housing is configured to be received by at least one of an organ perfusion device, an organ transporter and an organ diagnostic device, and includes openings configured to allow tubing to pass therethrough and be connected to the organ, and wherein a bottom portion of the housing is liquid-tight and configured to collect medical fluid that has passed through a perfused organ to form an organ bath, said apparatus further comprising a channel located in a top portion of the portable housing between said first lid and said second lid in which fluid overflow from the organ bath may be collected and detected.

2. The apparatus of claim 1, further comprising a valve supported on the housing and configured to control the pressure of medical fluid passed through tubing operably connected to said valve.

3. The apparatus of claim 2, wherein the valve is a variable valve.

4. The apparatus of claim 2, wherein the valve is selected from the group consisting of a stepping motor activated cam valve, a rotary screw valve and a helical screw valve.

5. The apparatus of claim 1, wherein said openings are closed with seals or plugs.

7. The apparatus of claim 1, further comprising supports configured to support the apparatus when inserted into at least one of an organ perfusion device, an organ transporter and an organ diagnostic device.

8. The apparatus of claim 1, wherein said first lid is removable.

9. The apparatus of claim 1, wherein said first lid is attached to said portable housing by a hinge.

10. The apparatus of claim 1, further comprising a port in said first lid, in said second lid or in both said first lid and said second lid or in the housing, for obtaining fluid and tissue samples from the organ.

11. The apparatus of claim 1, wherein said first lid and said second lid are transparent.

12. The apparatus of claim 1, further comprising:

tubing connectable to the organ to allow perfusion of the organ; and

at least one connection device configured to allow connection of the tubing to tubing of at least one of an organ perfusion device, an organ transporter and an organ diagnostic device.

13. The apparatus of claim 12, wherein said portable housing is movable to and from said organ perfusion device, organ transporter and organ diagnostic device by connecting and disconnecting said at least one connection device from tubing of said organ perfusion device, organ transporter and or an diagnostic device without opening said portable housing.

14. The apparatus of claim 12, wherein the bottom portion of the housing is configured to collect medical fluid that has passed through a perfused organ to form an organ bath, said apparatus further comprising, additional tubing for removing medical fluid from the organ bath.

15. The apparatus of claim 14, wherein said additional tubing has a filter attached thereto to prevent debris of 10 microns in diameter from passing through the additional tubing.

16. The apparatus of claim 1, wherein the bottom portion of the housing is configured to collect medical fluid that has passed through a perfused organ to form an organ bath, said apparatus further comprising a stopcock or removable plug contained in said portable housing for draining medical fluid from the organ bath.

17. The apparatus of claim 1, wherein said organ supporting surface is made of a mesh or porous material.

18. The apparatus of claim 1, wherein said organ supporting surface is removable from said portable housing.

19. The apparatus of claim 1, wherein said organ supporting surface is at least partially perforated to prevent organ debris of 15 microns in diameter from flowing therethrough.

20. The apparatus of claim 1, wherein said organ supporting surface is configured to channel outflow of the organ to allow sampling of the outflow.

21. The apparatus of claim 1, wherein the bottom portion of the housing is configured to collect medical fluid that has passed through a perfused organ to form an organ bath and wherein said organ supporting surface is configured to be raised and lowered within the portable housing and within the organ bath.

22. The apparatus of claim 1, wherein said organ supporting surface or said housing further comprise a tube that is attachable to perfused vasculature of the organ.

23. The apparatus of claim 22, wherein said tube comprises a clamp to secure said tube around the perfused vasculature.

24. The apparatus of claim 23, wherein said clamp comprises a mechanism that provides control of the pressure that the clamp exerts on the perfused vasculature to avoid damage to the vasculature and to provide leak-tight perfusion of the organ.

25. The apparatus of claim 22, wherein said tube comprises additional branching sections for attachment to accessory vasculatures.

26. The apparatus of claim 22, wherein said tube comprises a vent to remove air from the tube.

27. The apparatus of claim 22, wherein said organ supporting surface further comprises straps or belts to secure the organ to the organ supporting surface.

28. The apparatus of claim 1, wherein said portable housing associated with an imaging device to record the status or progress of the organ and/or organ perfusion.

29. The apparatus of claim 1, wherein said apparatus includes at least one of a bar code, magnetic tag, radio frequency tag, transmitter or global positioning system to monitor at least one of the location and identity of the apparatus.

30. The apparatus of claim 1, wherein the portable housing is configured to be received by at least two of an organ perfusion device, an organ transporter and an organ diagnostic device.

31. The apparatus of claim 1, wherein the portable housing is configured to be received by an organ perfusion device, an organ transporter and an organ diagnostic device.

32. The apparatus of claim 1, wherein the portable housing further comprises a closeable air vent.

6. The apparatus of plain 1, further comprising a handle disposed on an outer surface of the portable housing.

33. A saleable kit, comprising:

a portable housing;

a first lid;

a second lid interior to said first lid;

an organ supporting surface configured to support an organ while allowing effluent medical fluid to pass therethrough, wherein the portable housing is configured to be received by at least one of an organ perfusion device, an organ transporter and an organ diagnostic device, and includes openings configured to allow tubing to pass therethrough and be connected to the organ, and wherein a bottom portion of the housing is liquid-tight and configured to collect medical fluid that has passed through a perfused organ to form an organ bath;

said apparatus further comprising a channel located in a top portion of the portable housing between said first lid and said second lid in which fluid overflow from the organ bath may be collected and detected;

tubing connectable to the organ to allow perfusion of the organ; and

at least one connection device configured to allow connection of the tubing to at least one of an organ perfusion device, an organ transporter and an organ diagnostic device.

34. The kit of claim 33, wherein at least one of said portable housing and said at least one lid are transparent.

35. The kit of claim 33, wherein the portable housing is configured to be received by at least two of an organ perfusion device, an organ transporter and an organ diagnostic device.

36. The kit of claim 33, wherein the portable housing is configured to be received by an organ perfusion device, an organ transporter and an organ diagnostic device.

37. The kit of claim 33, wherein the portable housing further comprises a closeable air vent.

38. The kit of claim 33, wherein the kit is sterilized.

39. Apparatus for holding an organ for at least one of perfusion, storage, diagnosis and transport of the organ, comprising:

a portable housing;

a first cover;

a second cover interior to said first cover;

an organ supporting surface configured to support an organ within said housing while allowing effluent medical fluid to pass therethrough, wherein the portable housing is configured to be received by at least one of an organ perfusion device, an organ transporter and an organ diagnostic device, and includes openings configured to allow tubing to pass therethrough and be connected to the organ, and wherein a bottom portion of the housing is liquid-tight and configured to collect medical fluid that has passed through a perfused organ to form an organ bath, said apparatus further comprising a channel located in the top portion of the portable housing between said first cover and said second cover in which fluid overflow from the organ bath may be collected and detected.

40. The apparatus of claim 39, wherein said first cover is removable.

41. The apparatus of claim 39, wherein said first cover is attached to said portable housing by a hinge.

42. The apparatus of claim 39, further comprising a port in said first cover, in said second cover or in both said first cover and said second cover, for obtaining fluid and tissue samples from the organ.

43. The apparatus of claim 39, wherein said first cover and said second cover are transparent.

44. The apparatus of claim 39, wherein said organ supporting surface is at least partially perforated to prevent organ debris of at least 15 microns in diameter from flowing therethrough.

45. The apparatus of claim 39, wherein said organ supporting surface is configured to channel venous outflow of the organ to allow sampling of the venous outflow.

46. The apparatus of claim 39, wherein said organ supporting surface is configured to be raised and lowered within the portable housing and within the organ bath.

47. The apparatus of claim 39, wherein said organ supporting surface or said housing further comprise a cannula that is attachable to a perfused artery of the organ.

48. The apparatus of claim 47, wherein said cannula comprises a cannula clamp to secure said cannula around the perfused artery.

49. The apparatus of claim 48, wherein said cannula clamp comprises a tightening mechanism that provides control of the pressure that the cannula clamp exerts on the perfused artery to avoid damage to the artery and to provide leak-tight perfusion of the organ.

50. The apparatus of claim 47, wherein said cannula comprises additional branching sections for attachment to accessory arteries.

51. The apparatus of claim 47, wherein said cannula comprises a vent to remove air from the cannula.

52. The apparatus of claim 47, wherein said organ supporting surface further comprises straps or belts to secure the organ to the organ supporting surface.

53. The apparatus of claim 39, wherein said portable housing associated with a video camera or still camera to record the status or progress of the organ and/or organ perfusion.

54. The apparatus of claim 39, wherein the portable housing is configured to be received by at least two of an organ perfusion device an organ transporter and an organ diagnostic device.

55. The apparatus of claim 39, wherein the portable housing is configured to be received by an organ perfusion device, an organ transporter and an organ diagnostic device.

56. The apparatus of claim 39, wherein the portable housing further comprises a closeable air vent.

57. The apparatus of claim 39, further comprising:

tubing connectable to the organ to allow perfusion of the organ; and

at least one connection device configured to allow connection of the tubing to tubing of at least one of an organ perfusion device, an organ transporter and an organ diagnostic device.

58. The apparatus of claim 57, wherein said portable housing is movable to and from said organ perfusion device, organ transporter and organ diagnostic device by connecting and disconnecting said at least one connection device from tubing of said organ perfusion device, organ transporter and organ diagnostic device without opening said portable housing.

59. The apparatus of claim 57, further comprising a stopcock or removable plug contained in said portable housing for draining medical fluid from the organ bath.

60. The apparatus of claim 57, further comprising additional tubing for removing medical fluid from the organ bath.

61. The apparatus of claim 60, wherein said additional tubing has a filter attached thereto to prevent organ debris of at least 10 to 15 microns in diameter from entering the additional tubing.

62. The apparatus of claim 39, wherein said organ supporting surface is made of a mesh or porous material.

63. The apparatus of claim 39, wherein said organ supporting surface is removable from said portable housing.

64. Apparatus for holding an organ for at least one of perfusion, storage, diagnosis and transport of the organ, comprising:

a portable housing;

an organ supporting surface configured to support an organ within said housing, wherein the portable housing is configured to be received by at least one of an organ perfusion device, an organ transporter and an organ diagnostic device, and includes openings configured to allow tubing to pass therethrough and be connected to the organ, and wherein a bottom portion of the housing is liquid-tight;

wherein said organ supporting surface or said housing further comprise a tube that is attachable to perfused vasculature of the organ, and

detents, tracks or grooves that interact with a protruding region of said tube to allow said tube to be secured at various positions on the detents, tracks or grooves of the organ supporting surface or the housing.

65. Apparatus for holding an organ for at least one of perfusion, storage, diagnosis and transport of the organ, comprising:

a portable housing;

an organ supporting surface configured to support an organ within said housing while allowing effluent medical fluid to pass therethrough, wherein the portable housing is configured to be received by at least one of an organ perfusion device, an organ transporter and an organ diagnostic device, and includes openings configured to allow tubing to pass therethrough and be connected to the organ, and wherein a bottom portion of the housing is liquid-tight and configured to collect medical fluid that has passed through a perfused organ to form an organ bath;

wherein said organ supporting surface or said housing further comprise a cannula that is attachable to a perfused artery of the organ, and

detents, tracks or grooves that interact with a protruding region of said cannula to allow said cannula to be secured at various positions on the detents, tracks or grooves of the organ supporting surface or the housing.