Ex vivo organ care system

• US 10,076,112 B2
• Filed: 06/02/2015
• Issued: 09/18/2018
• Est. Priority Date: 06/02/2014
• Status: Active Grant

• Current Assignee: TransMedics, Inc. (TransMedics Group, Inc.)
• Original Assignee: Transmedic Incorporated
• Inventors: Hassanein, Waleed H., Khayal, Tamer I., Elbetanony, Ahmed, Barnes, Jeff, Ritchie, Greg, Bringham, Richard, Anderson, Mark, Sullivan, John
• Primary Examiner(s): BOWERS, NATHAN ANDREW
• Application Number:
  US14/728,771
• Publication Number:
  US 20150342177A1
• Time in Patent Office: 1,204 Days
• CPC Class Codes: A01N 1/0247 for perfusion, i.e. for circulating fluid through organs, blood vessels or other living parts
• CPC Class Codes: C12M 21/08 for producing artificial tissue or for ex-vivo cultivation of tissue prostheses A61F2/00, grafts A61L27/00
• CPC Class Codes: C12M 29/10 Perfusion

Abstract

The invention generally relates to systems, methods, and devices for ex vivo organ care. More particularly, in various embodiments, the invention relates to caring for a liver ex vivo at physiologic or near-physiologic conditions.

Claims

1. A perfusion circuit for perfusing a liver ex-vivo comprising:

A pump for providing pulsatile fluid flow of a perfusion fluid through the circuit;

a gas exchanger;

a divider in fluid communication with the pump configured to divide the perfusion fluid flow into a first branch and a second branch;

wherein the first branch comprises a hepatic artery interface;

wherein the first branch is configured to provide a first portion of the perfusion fluid to a hepatic artery of the liver at a high pressure between 25-150 mmHg and low flow rate between 0.25-1 L/min via the hepatic artery interface;

wherein the first branch is in fluid pressure communication with the pump;

wherein the second branch comprises a portal vein interface;

wherein the second branch is configured to provide a second portion of the perfusion fluid to a portal vein of the liver at a low pressure between 1-25 mmHg and high flow rate between 0.75 to 2 L/min via the portal vein interface;

the second branch further comprising a clamp located between the divider and the portal vein interface for selectively controlling the flow rate of perfusion fluid to the portal vein;

the second branch further comprising a compliance chamber configured to reduce the pulsatile flow characteristics of the perfusion fluid from the pump to the portal vein;

wherein the pump is configured to provide a pulsatile flow of perfusion fluid through the first branch including the hepatic artery interface to provide the first portion of the perfusion fluid to the hepatic artery of the liver at the high pressure between 25-150 mmHg and low flow rate between 0.25-1 L/min and the second branch including the portal vein interface to provide a second portion of the perfusion fluid to the portal vein of the liver at the low pressure between 1-25 mmHg and high flow rate between 0.75 to 2 L/min;

a drain configured to receive perfusion fluid from an inferior vena cava of the liver; and

a reservoir positioned below the liver and located between drain and the pump, configured to receive the perfusion fluid from the drain and store a volume of fluid.

2. The perfusion circuit of claim 1, wherein the second branch comprises a plurality of compliance chambers.

3. The perfusion circuit of claim 1, wherein the compliance chamber is located between the divider and the portal vein interface.

4. The perfusion circuit of claim 1, wherein the portal vein interface has a larger cross sectional area than the hepatic artery interface.

5. The perfusion circuit of claim 1 further comprising at least one flow rate sensor in the second branch, and at least one pressure sensor.

6. The perfusion circuit of claim 1, wherein the pump comprises a pump driver, and wherein the position of the pump driver is adjustable to control the pattern of pulsatile flow to the liver.

7. The perfusion circuit of claim 1, wherein the clamp comprises an engaged position and a disengaged position;

wherein the clamp may be adjusted to select the desired clamping force and corresponding flow rate when the clamp is in the disengaged position;

wherein the clamp may be moved to the engaged position to apply the selected clamping force without further adjustment when in the engaged position, such that the user may engage and disengage the clamp while still having precise control over the amount of clamping force applied to the perfusion circuit.

8. A system for perfusing an ex vivo liver at near physiologic conditions comprising:

a perfusion circuit comprising;

a pump for pumping a pulsatile perfusion fluid flow through the circuit;

a divider in fluid communication with the pump configured to divide the perfusion fluid into a hepatic artery interface and a portal vein interface;

wherein the pump provides perfusion fluid to a hepatic artery of the liver at a high pressure between 25-150 mmHg and low flow rate between 0.25-1 L/min via the divider and the hepatic artery interface; and

wherein the pump provides perfusion fluid to the portal vein of the liver at a low pressure between 1-25 mmHg and high flow rate between 0.75 to 2 L/min via the divider and the portal vein interface;

a gas exchanger;

a heating subsystem for maintaining the temperature of the perfusion fluid at a normothermic temperature;

a drain configured to receive the perfusion fluid from an inferior vena cava of the liver;

a reservoir configured to receive perfusion fluid from the drain and store a volume of fluid.

9. The system of claim 8, wherein the heating subsystem is configured to maintain the perfusion fluid at a temperature between 34-37°

C.

10. The system of claim 8, wherein the perfusion circuit further comprises an inferior vena cava cannula.

11. The system of claim 8, further comprising a control system for controlling operation of the system:

an onboard computer system connected to one or more of the components in the system;

a data acquisition subsystem comprising at least one sensor for obtaining data relating to the organ; and

a data management subsystem for storing and maintaining data relating to operation of the system and with respect to the liver.

12. The system of claim 8, wherein the heating subsystem further comprising a dual feedback loop for controlling the temperature of the perfusion fluid within the system.

13. A system for preserving a liver ex vivo at physiologic conditions comprising:

a multiple use module comprising a pulsatile pump;

a single use module comprising;

a perfusion circuit configured to provide pulsatile perfusion fluid flow to the liver;

a pump interface assembly for translating pulsatile pumping from the pump to the perfusion fluid;

a hepatic artery interface configured to deliver perfusion fluid to a hepatic artery of the liver;

a portal vein interface configured to deliver perfusion fluid to a portal vein of the liver;

a divider to supply the pulsatile perfusion fluid flow from the pump interface assembly to the hepatic artery interface at a high pressure between 25-150 mmHg and low flow rate between 0.25-1 L/min and to the portal vein interface at a low pressure between 1-25 mmHg and high flow rate between 0.75 to 2 L/min;

an organ chamber assembly configured to hold an ex vivo organ, the organ chamber assembly including a housing;

a flexible support surface suspended within the organ chamber assembly; and

a bile container configured to collect bile produced by the liver.

14. The system of claim 13, wherein the flexible support surface is configured to conform to differently sized organs, and further comprising projections to stabilize the liver in the organ chamber assembly.

15. The system of claim 13, wherein the flexible support surface comprises a top layer, a bottom layer, and a deformable metal substrate positioned between the top layer and the bottom layer.

16. The system of claim 13, wherein the flexible support surface is configured to cradle and controllably support the liver without damaging the liver.

17. The system of claim 13, wherein the single use module further comprises a wrap configured to cover the liver in the organ chamber assembly.

18. The system of claim 13, wherein the single use module further comprises a sensor to measure the volume of bile collected in the bile container.

19. The system of claim 13, wherein the single use module can be sized and shaped for interlocking with a portable chassis of the multiple use module for electrical, mechanical, gas and fluid interoperation with the multiple use module.

20. The system of claim 13 wherein the multiple and single use modules can communicate with each other via an optical interface, which comes into optical alignment automatically upon the single use disposable module being installed into the portable multiple use module.