Systems and methods for ex-vivo organ care

• US 20060148062A1
• Filed: 10/07/2005
• Published: 07/06/2006
• Est. Priority Date: 10/07/2004
• Status: Active Grant

• Current Assignee: TransMedics, Inc. (TransMedics Group, Inc.)
• Original Assignee: TransMedics, Inc. (TransMedics Group, Inc.)
• Inventors: Algamil, Hoss, Hassanein, Waleed, Khayal, Tamer, Taylor, Ronald, Bringham, Richard, Cecere, Giovanni
• Granted Patent: US 9,215,867 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 chamber assembly for containing an organ for preservation, the chamber assembly comprising,

a housing having a bottom and walls for containing the organ,

an intermediate lid for covering an opening to the housing for substantially enclosing the organ within the housing, the intermediate lid including a frame and flexible membrane suspended within the frame, the flexible membrane containing sufficient excess membrane material to contact an organ contained within the chamber for providing a medical operator with indirect contact with the organ, and

an outer lid independently operable from the intermediate lid for covering, at least partially, the intermediate lid.

2. The organ chamber assembly of claim 1, wherein the flexible membrane is substantially opaque.

3. The organ chamber assembly of claim 1, wherein the flexible membrane is substantially translucent.

4. The organ chamber assembly of claim 1, wherein the flexible membrane is substantially transparent.

5. The chamber assembly of claim 1 comprising at least one intermediate lid hinge for mechanically coupling the intermediate lid with the housing for providing hinged interoperation between the intermediate lid and the housing.

6. The chamber assembly of claim 1 comprising an intermediate lid latch for latching the intermediate lid closed on the housing independent from latching the outer lid closed.

7. The chamber assembly of claim 1 comprising an outer lid hinge for mechanically coupling the intermediate -lid with the housing for providing hinged interoperation between the outer lid and the housing.

8. The chamber assembly of claim 1 comprising an outer lid latch for latching the outer lid closed on the housing independent from latching the intermediate lid closed.

9. The chamber assembly of claim 1 comprising a gasket between the intermediate lid frame and one or more walls of the housing for providing a sealing interconnection between the intermediate lid and the walls of the housing.

10. The chamber assembly of claim 1 comprising a gasket between the intermediate lid frame and the outer lid for providing a sealing interconnection between the intermediate lid and the outer lid.

11. The chamber assembly of claim 1 comprising at least two ports for directing fluid to and from the organ.

12. The chamber assembly of claim 11 comprising a bypass tube for transferring fluid from first and second ones of the three ports through the chamber to a third one of the three ports out of the chamber.

13. The chamber assembly of claim 1 comprising a fluid drain for draining fluids out of the chamber into a reservoir.

14. The chamber assembly of claim 1 comprising a port including a flexible resealing membrane for being punctured for providing direct contact with an organ contained within the chamber.

15. The chamber assembly of claim 1 comprising,

a pad assembly including a pad sized and shaped for interfitting within a bottom of the housing, and at least a first electrode adjustably positionable between the pad and an organ on the pad for sutureless contact with the organ.

16. The chamber assembly of claim 15, wherein the first electrode is configured for providing an electrical stimulation to the organ.

17. The chamber assembly of claim 15, wherein the first electrode is configured for sensing electrical signals from the heart.

18. The system of claim 17, wherein the signals include an r-wave for the heart.

19. The chamber assembly of claim 15, wherein the pad includes a first through aperture for passing an electrical lead to the first electrode.

20. The chamber assembly of claim 15 comprising a second electrode adjustably positionable between the pad and the organ on the pad for contacting the organ, and wherein the pad includes a second through aperture for passing an electrical lead to the second electrode.

21. The chamber assembly of claim 1 including one or more electrical ports for transferring electrical signals from one or more electrodes within the chamber to instrumentation external to the housing.

22. The chamber assembly of claim 1 comprising one or more electrical ports for providing one or more electrical defibrillation signals into the housing from an external power source.

23. The chamber assembly of claim 1 comprising first and second fluid ports in a first wall of the housing, a third port in a second wall of the housing, and a base for elevating the first and second ports upward relative to a horizontal plane passing through the third port.

24. An organ chamber assembly for containing an organ for preservation, the chamber assembly comprising,

a housing having a bottom and walls for containing the organ,

a lid for covering the housing to substantially enclose the organ,

a pad sized and shaped for being positioned in a bottom portion of the housing for supporting the organ, and

at least one electrode located on the pad and placed to be in contact with the organ.

25. The chamber assembly of claim 24, wherein the at least one electrode is location-adjustably mounted to the pad.

26. The chamber assembly of claim 24, wherein the pad includes a through aperture for passing an electrical lead of the at least one electrode.

27. The chamber assembly of claim 24, wherein the at least one electrode is removably, repositionably glue mounted to the pad.

28. An organ chamber assembly for containing an organ for preservation, the chamber assembly comprising,

a housing having a bottom and walls for containing the organ,

a lid for covering the housing to substantially enclose the organ, and

electrodes located in a bottom portion of the housing and positioned for contact with the organ.

29. The chamber assembly of claim 28, wherein the electrodes are repositionably located within the bottom portion of the housing.

30. An organ care system comprising:

a chamber assembly for containing an organ for preservation, the chamber assembly including,

a housing having a bottom and walls for containing the organ,

an intermediate lid for covering an opening to the housing for substantially enclosing the organ within the housing, the intermediate lid including a frame and flexible membrane suspended within the frame, the flexible membrane containing sufficient excess membrane material to contact an organ contained within the chamber for providing a medical operator with indirect contact with the organ, and

an outer lid independently operable from the intermediate lid for covering, at least partially, the intermediate lid; and

a pump for circulating a perfusion solution to the organ to preserve the organ.

31. An organ care system comprising:

an organ chamber assembly for containing an organ for preservation, the chamber assembly comprising,

a housing having a bottom and walls for containing the organ,

a lid for covering the housing to substantially enclose the organ,

a pad sized and shaped for being positioned in a bottom portion of the housing for supporting the organ, and

at least one electrode located on the pad and placed to be in contact with the organ; and

a pump for circulating a perfusion solution to the organ to preserve the organ.

32. An care preservation system comprising:

an organ chamber assembly for containing an organ for preservation, the chamber assembly comprising,

a housing having a bottom and walls for containing the organ,

a lid for covering the housing to substantially enclose the organ, and

electrodes located in a bottom portion of-the housing and positioned for contact with the organ; and

a pump for circulating a perfusion solution to the organ to preserve the organ.

33. An organ care system comprising:

an organ chamber assembly for containing an organ for preservation, the chamber assembly comprising,

a housing having a bottom and walls for containing the organ,

a lid for covering the housing to substantially enclose the organ, and

electrodes located in a bottom portion of the housing and positioned for contact with the organ;

a pump for circulating a perfusion solution to the organ to preserve the organ; and

a heater for heating the perfusion solution.