Compositions, methods and devices for maintaining an organ

• US 9,756,850 B2
• Filed: 02/10/2017
• Issued: 09/12/2017
• Est. Priority Date: 09/23/1997
• Status: Expired due to Fees

• Current Assignee: US Department of Veterans Affairs (Government of the United States of America)
• Original Assignee: US Department of Veterans Affairs (Government of the United States of America)
• Inventors: Hassanein, Waleed H., Khuri, Shukri, Crittenden, Michael D., Birjinuik, Vladimir
• Primary Examiner(s): BOWERS, NATHAN ANDREW
• Application Number:
  US15/430,035
• Publication Number:
  US 20170150712A1
• Time in Patent Office: 214 Days
• CPC Class Codes: A01N 1/02 Preservation of living parts
• CPC Class Codes: A01N 1/021 Preservation or perfusion media, liquids, solids or gases used in the preservation of cells, tissue, organs or bodily fluids
• 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 1/0278 Physical preservation processes

Abstract

Compositions, methods, systems/devices and media are provided for maintaining a harvested organ in a functioning and viable state prior to implantation. The organ perfusion apparatus includes a preservation chamber for storing the organ during the preservation period. A perfusion circuit is provided having a first line for providing an oxygenated fluid to the organ, and a second line for carrying depleted fluid away from the organ. The perfusion apparatus also includes a device operably associated with the perfusion circuit for maintaining the organ at a substantially normothermic temperature.

Claims

1. A preservation system, comprising

a chamber assembly for containing a liver,

a perfusion circuit including a first conduit for providing an oxygenated fluid to the liver, and a second conduit for carrying depleted fluid away from the liver,

a cannula for allowing a flow of bile away from the liver,

a reservoir disposed along the perfusion circuit for containing a portion of the fluid, the reservoir including an inlet for receiving the fluid from the perfusion circuit and outlet for supplying the fluid to the perfusion circuit,

a pump for circulating the fluid through the perfusion circuit,

an oxygenating device disposed along the perfusion circuit to maintain the fluid at physiologic levels of oxygenation, and

a temperature control device that has a heater and a temperature control sufficient to maintain the fluid at a temperature of greater than 25°

C. to approximately 37°

C.,

wherein the pump, oxygenating device, and the temperature control device are adapted to operate with the perfusion circuit to maintain the liver in a functioning and viable state in an ex-vivo environment.

2. The system of claim 1 including a housing for integrating the chamber and at least a portion of the perfusion circuit into a portable assembly.

3. The system of claim 1 including a portable power source for the system.

4. The system of claim 1 including at least one probe for measuring flow rate of the fluid.

5. The system of claim 1, wherein the chamber assembly includes a flexible portion.

6. The system of claim 1, wherein the chamber assembly is substantially transparent.

7. The system of claim 1, wherein the chamber assembly is a soft shell bag.

8. The system of claim 7, wherein the soft shell bag comprises a sealed body portion and a preservation chamber.

9. The system of claim 1 including a selector valve for providing an alternative flow path to the liver.

10. The system of claim 1 including a filter.

11. The system of claim 1, wherein the chamber assembly includes a surface for operationally mating with a corresponding structure in the system.

12. The system of claim 11, wherein the mating is removable and reversible.

13. The system of claim 1, further comprising a monitor of the physiologic conditions of the liver, wherein the pump, the temperature control device, the oxygenating device, and the monitor are adapted to operate with the perfusion circuit to maintain the liver in a functioning and viable state in an ex-vivo environment.

14. The system of claim 13, wherein the monitor is a monitor selected from the group consisting of a bile production monitor, an ultrasound monitor, a liver function blood test monitor, or a fibrinogen blood level monitor.

15. The system of claim 13, wherein the monitor performs a metabolic assessment of the liver.

16. The system of claim 1 wherein the first conduit is an arterial fitting integrally formed with the chamber assembly.

17. A portable preservation system for maintaining an ex vivo liver in a near physiologic state, the system comprising:

a container configured to hold the liver;

an oxygenator configured to oxygenate a perfusion fluid;

a perfusion circuit in communication with the oxygenator, the perfusion circuit comprising;

a first fluid line configured to deliver the perfusion fluid from the oxygenator to a portal vein of the liver;

a second fluid line configured to deliver the perfusion fluid from the oxygenator to a hepatic artery of the liver; and

an outlet fluid line configured to carry the perfusion fluid away from the container;

a cannula configured to flow bile away from the liver;

a heater coupled to the perfusion circuit and configured to heat the perfusion fluid to a temperature of greater than 25°

C. to about 37°

C.;

a pump configured to circulate the perfusion fluid through the perfusion circuit and the liver;

a fluid reservoir coupled to the perfusion circuit and configured to contain a portion of the perfusion fluid;

a sensor configured to measure a parameter of the perfusion fluid in the perfusion circuit;

a processor configured to receive the parameter, the processor being in communication with at least one of the oxygenator, the heater, the pump, and the sensor.

18. The system of claim 17 further comprising a display screen coupled to the processor.

19. The system of claim 17, wherein the sensor is configured to measure a flow rate of the perfusion fluid within the perfusion circuit.

20. The system of claim 17, wherein the sensor is configured to measure an oxygen level of the perfusion fluid within the perfusion circuit.

21. The system of claim 17 further comprising a mobile cart, wherein the system is configured to be placed on a mobile cart to transport the system from a first location to a second location.

22. The system of claim 17, wherein the first fluid line and the second fluid line are configured to simulate a human cardiovascular system.

23. The system of claim 17, wherein the oxygenator includes a membrane oxygenator.

24. The system of claim 17, wherein at least one valve is disposed in the perfusion circuit.

25. The system of claim 17, wherein the display screen is configured to display the at least one parameter measured by the sensor.

26. The system of claim 17, further comprising a vessel to collect bile.

27. A method of maintaining an ex vivo liver in a near physiologic state, the method comprising:

placing a liver in a container;

oxygenating a perfusion fluid;

cannulating the liver to allow a flow of bile away from the liver;

pumping the perfusion fluid in a perfusion circuit coupled to the liver to provide the perfusion fluid to a portal vein of the liver and to a hepatic artery of the liver;

heating the perfusion fluid to a temperature of greater than 25°

C. to about 37°

C.;

receiving the perfusion fluid from the liver in a reservoir;

containing the perfusion fluid in the reservoir;

measuring a parameter of the perfusion fluid in the perfusion circuit; and

controlling at least one of the pumping and the heating in response to the measured parameter.