Systems and methods for ex-vivo organ care

• US 9,215,867 B2
• Filed: 10/07/2005
• Issued: 12/22/2015
• 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, Khayal, Tamer, Taylor, Ronald, Algamil, Hossam
• Primary Examiner(s): HOBBS, MICHAEL L
• Application Number:
  US11/245,957
• Publication Number:
  US 20060148062A1
• Time in Patent Office: 3,728 Days
• Field of Search: 435/1.2, 435/268, 435/297.2, 312/1
• US Class Current: 1/1
• 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 sized for containing the organ, wherein the organ is a heart;

an intermediate lid for covering an opening to the housing for substantially enclosing the organ within the housing, the intermediate lid including a frame sized to substantially cover an outer rim of the opening, and a flexible membrane attached to and suspended within the frame, the flexible membrane being configured to allow an operator to manipulate an organ contained within the chamber while still maintaining sterility of the system and the organ, the intermediate lid being coupled to the housing an intermediate lid hinge such that the intermediate lid is independently movable from the housing; and

an outer lid independently operable from the intermediate lid for covering, at least partially, the intermediate lid, the outer lid being coupled to at least one of the intermediate lid and the housing an outer lid hinge.

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 an intermediate lid latch for latching the intermediate lid closed on the housing independent from latching the outer lid closed.

6. 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.

7. 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 one or more walls of the housing.

8. 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.

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

10. The chamber assembly of claim 9 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.

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

12. 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.

13. 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.

14. The chamber assembly of claim 13, wherein the first electrode is configured for providing an electrical stimulation to the organ.

15. The chamber assembly of claim 12, wherein the first electrode is configured for sensing electrical signals from the heart.

16. The system of claim 15, wherein the signals include an r-wave for the heart.

17. The chamber assembly of claim 13, wherein the pad includes a first through aperture for passing an electrical lead to the first electrode.

18. The chamber assembly of claim 13 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.

19. 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.

20. 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.

21. 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.

22. 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 sized for containing the organ, wherein the organ is a heart;

an intermediate lid for covering an opening to the housing for substantially enclosing the organ within the housing, the intermediate lid including a frame sized to substantially cover an outer rim of the opening, and a flexible membrane attached to and suspended within the frame, the flexible membrane being configured to allow an operator to manipulate an organ contained within the chamber while still maintaining sterility of the system and the organ, the intermediate lid being coupled to the housing an intermediate lid hinge such that the intermediate lid is independently movable from the housing;

an outer lid independently operable from the intermediate lid for covering, at least partially, the intermediate lid, the outer lid being coupled to at least one of the intermediate lid and the housing an outer lid hinge; and

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