Systems and methods for ex-vivo organ care

• US 8,585,380 B2
• Filed: 10/07/2005
• Issued: 11/19/2013
• 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, Fishman, Robert, Goff, Larry, Kyi, Stanley, Rourke, Jonathan, Menn, Dmitri, Carpenter, David, Havner, Robert
• Primary Examiner(s): BOWERS, NATHAN ANDREW
• Application Number:
  US11/245,958
• Publication Number:
  US 20060160204A1
• Time in Patent Office: 2,965 Days
• Field of Search: 435/284.1, 435/289.1, 435/1.1, 435/1.2, 417/437, 417/475, 417/443, 417/472, 417/474, 417/460, 417/510
• US Class Current: 417/510
• 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. A pump interface assembly removable from a pump driver assembly in an organ care system that maintains an organ in a physiological state, the pump interface assembly comprising:

a housing including an exterior side and an interior side;

a first deformable membrane in fluid tight interconnection with the interior side of the housing to define a chamber between an interior side of the deformable membrane and an interior side of the housing,

wherein the housing is configured to removably dock with the pump driver assembly and includes;

a flange extending from the exterior side of the housing and configured to mate with a slot defined in the pump driver assembly; and

a projection disposed on the exterior side of the housing configured to abut one or more surfaces of the pump driver assembly to force the housing in a direction toward a pump driver of the pump driver assembly as the housing is rotated relative to the pump driver assembly, to form a fluid tight seal between the housing and the pump driver assembly,

a fluid inlet for receiving an organ perfusion fluid and for providing the fluid into the chamber, and

a fluid outlet for expelling the organ perfusion fluid out of the chamber in response to the pump driver deforming the first deformable membrane in a direction toward the interior side of the housing

wherein the organ care system and the pump driver assembly can be reused more than once and the pump interface and housing can be discarded after a single use of housing an organ maintained in a physiologic state.

2. The pump interface assembly of claim 1 including a bracket for fitting over a periphery of the first deformable membrane to form a fluid tight seal between the a periphery of the interior side of the deformable membrane and a periphery of the interior side of the housing.

3. The pump interface assembly of claim 1 including a gasket for providing a fluid tight interconnection with the pump driver assembly.

4. The pump interface assembly of claim 1 wherein the fluid outlet is a one way fluid outlet.

5. The pump interface assembly of claim 4, wherein the one way fluid outlet includes a ball valve assembly oriented to close in response to the pump driver moving in a direction away from the interior surface of the housing, and oriented to open to expel the organ perfusion fluid through the fluid outlet in response to the pump driver moving in a direction to deform the first deformable membrane toward the interior side of the housing.

6. The pump interface assembly of claim 1 comprising a second deformable membrane mounted adjacent to the first deformable membrane to provide a fault tolerant seal in case the first deformable membrane fails.

7. The pump interface assembly of claim 1, wherein the pump interface assembly is formed at least in part from a polycarbonate.

8. The pump interface assembly of claim 1, wherein the pump interface assembly is a single use disposable assembly.

9. The pump interface assembly of claim 1, wherein the fluid inlet is sized, shaped and oriented for receiving a gravity feed of the perfusion fluid.

10. A pump system for use with an organ care system that maintains an organ in a physiologic state, the pump system comprising:

a pump driver assembly defining a slot and including;

a pump driver;

a docking port; and

an outer surface;

a pump interface assembly configured to removably connect to the pump driver assembly, the pump interface assembly including;

a housing having an exterior side and an interior side;

a first deformable membrane in fluid tight interconnection with the interior side of the housing to define a chamber between an interior side of the deformable membrane and the interior side of the housing, the membrane being configured to fluidly isolate the pump driver from the chamber;

a flange extending form the exterior side of the housing and configured to mate with the slot;

a projection disposed on the exterior side of the housing configured to abut the outer surface of the pump driver assembly to force the housing in a direction toward the pump driver assembly as the housing is rotated relative to the pump driver assembly, to form a fluid tight seal between the housing and the pump driver assembly;

a fluid inlet for receiving a perfusion fluid and for providing the fluid into the chamber, and

a fluid outlet for expelling the organ perfusion fluid out of the chamber in response to the pump driver deforming the deformable membrane in a direction toward the interior side of the housing,

wherein the pump driver assembly is disposed on the organ care system and the housing is disposed on the pump interface assembly such that when the pump interface assembly is disposed on the organ care system, the pump driver is capable of driving the pump interface.

11. The system of claim 10, wherein the pump interface assembly includes a bracket for fitting over a periphery of the first deformable membrane to form a fluid tight seal between a periphery of the interior side of the deformable membrane and a periphery of the interior side of the housing.

12. The system of claim 10, wherein the pump interface assembly includes a gasket for providing a fluid tight interconnection with the pump driver assembly.

13. The system of claim 10 wherein the fluid outlet is a one way fluid outlet.

14. The system of claim 13, wherein the one way fluid outlet includes a ball valve assembly oriented to close in response to the pump driver moving in a direction away from the interior surface of the housing, and oriented to open to expel the organ perfusion fluid through the fluid outlet in response to the pump driver moving in a direction to deform the first deformable membrane toward the interior side of the housing.

15. The system of claim 10 comprising a second deformable membrane mounted adjacent to the first deformable membrane to provide a fault tolerant seal in case the first deformable membrane fails.

16. The system of claim 10, wherein the pump interface assembly is formed at least in part from a polycarbonate.

17. The system of claim 10, wherein the pump interface assembly is a single use disposable assembly.

18. The system of claim 10, wherein the fluid inlet is sized, shaped and oriented for receiving a gravity feed of the perfusion fluid.