SYSTEMS AND METHODS FOR EX VIVO LUNG CARE

• US 20090197240A1
• Filed: 04/08/2008
• Published: 08/06/2009
• Est. Priority Date: 01/31/2008
• Status: Active Grant

• Current Assignee: TransMedics, Inc. (TransMedics Group, Inc.)
• Original Assignee: TransMedics, Inc. (TransMedics Group, Inc.)
• Inventors: Sullivan, John, Murray, Paul, Kyi, Stanley, Fattah, Ihab Abdel, Havener, Robert, Hassanein, Waleed, Khayal, Tamer, Newell, Scott, Anderson, Mark, Bringham, Richard, Fishman, Robert, Van Driel, Michael, De Remer, Matthew, Bishop, Tom, Taylor, Ron, Harriott, Doug, Abdelazim, Anas
• Granted Patent: US 9,247,728 B2
• Time in Patent Office: Days
• US Class Current: 435/1.2
• 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

Abstract

Methods and systems of maintaining, evaluating, and providing therapy to a lung ex vivo. The methods and systems involve positioning the lung in an ex vivo perfusion circuit; circulating a perfusion fluid through the lung, the fluid entering the lung through a pulmonary artery interface and leaving the lung through a left atrial interface; and ventilating the lung by flowing a ventilation gas through a tracheal interface. Maintaining the lung for extended periods involves causing the lung to rebreath a captive volume of air, and reaching an equilibrium state between the perfusion fluid and the ventilation gas. Evaluating the gas exchange capability of the lung involves deoxygenating the perfusion fluid and measuring a time taken to reoxygenate the perfusion fluid by ventilating the lung with an oxygenation gas.

Claims

1. A lung care module comprising:

a single use disposable module including

an interface adapted for attachment to the multiple use module, and

a lung chamber assembly having a first interface for allowing a flow of a perfusion fluid into the lung and a second interface for allowing ventilation of the lung with a ventilation gas; and

a drain system for draining a flow of perfusion fluid from the lung chamber assembly, the drain system including a measurement conduit and a main drain conduit, the measurement conduit further directing a flow of perfusion fluid to a sensor that is adapted to measure a perfusion fluid gas content.

2. The system of claim 1 further comprising a ventilation system connected to the second interface for ventilating the lung with a gas.

3. The system of claim 2, wherein the gas is selectable from a plurality of gases, each of the plurality of gases having a predetermined composition.

4. The system of claim 3, wherein the plurality of gases includes a maintenance gas, an assessment gas, and air.

5. The system of claim 4, wherein the predetermined composition of the maintenance gas includes about 12% oxygen.

6. The system of claim 4, wherein the predetermined composition of the maintenance gas is about 12% oxygen, about 5.5% carbon dioxide, and about 82.5% nitrogen.

7. The system of claim 2, wherein the ventilation system can be configured to cause the lung to rebreath a volume of the maintenance gas.

8. The system of claim 7, wherein the ventilation system includes an isolated volume compartment, and the volume of maintenance gas is cycled between the lung and the isolated volume compartment.

9. The system of claim 7, wherein the ventilation system includes a bellows, and the volume of maintenance gas is cycled between the lung and the bellows by actuating the bellows.

10. The system of claim 7 wherein the ventilation system includes a connection to an external supply of maintenance gas via a trickle valve, the trickle valve releasing the gas into the ventilation system to maintain the predetermined composition of the maintenance gas in the ventilation system.

11. The system of claim 2, wherein the ventilation system further comprises a relief valve, the relief valve maintaining a minimum gas pressure in the lung.

12. The system of claim 4, wherein the predetermined composition of the assessment gas includes about 6% carbon dioxide.

13. The system of claim 4, wherein the predetermined composition of the assessment gas includes about 4-7% carbon dioxide and about 93-97% nitrogen.

14. The system of claim 1, wherein the second interface includes a tracheal cannula.

15. The system of claim 14, wherein the tracheal cannula comprises a tracheal insertion portion for inserting into the trachea, a flexible portion, a locking mechanism for securing the tracheal cannula to the lung chamber assembly, and a ventilator connector portion.

16. The system of claim 15, wherein the tracheal insertion portion has a diameter of about 0.65 inches to 0.95 inches.

17. The system of claim 15, wherein the flexible portion can be clamped to seal off gas flow in and out of the lung.

18. The system of claim 1 further comprising a pump adapted to flow the perfusion fluid into and away from the lung.

19. The system of claim 18 further comprising a heater in thermal contact with the perfusion fluid for maintaining a temperature of the perfusion fluid at a near physiologic level.

20. The system of claim 19, wherein the temperature is between about 30°

C. and 37°

C.

21. The system of claim 19, wherein the temperature is between about 34°

C. and 37°

C.

22. The system of claim 18 further comprising a gas exchange device in fluid communication with at least one gas supply and the perfusion fluid, the gas exchange device being adapted to controllably modulate the composition of a first gas component in the perfusion fluid.

23. The system of claim 22 further comprising a gas select switch for selecting from a plurality of gas supplies to modulate the composition of a gas component in the perfusion fluid.

24. The system of claim 18, wherein the first interface includes a pulmonary artery cannula.

25. The system of claim 24, wherein the pulmonary artery cannula includes an insertion tube for insertion into a pulmonary artery, a connector portion connected to the insertion tube, and a main tube portion connected to the connector portion for connection to a circuit carrying the flow of perfusion fluid into the lung.

26. The system of claim 25, wherein the pulmonary artery cannula further includes a pressure transducer connector, the pressure transducer connector defining an opening into a lumen of the connector portion near the insertion tube for positioning a pressure transducer near a point of entry of the perfusion fluid into the lung.

27. The system of claim 26, wherein the pressure transducer connector further provides a channel for the pressure transducer to be remotely vented.

28. The system of claim 26 wherein the pulmonary artery cannula includes two insertion tubes.

29. The system of claim 26, wherein the insertion tubes are angled apart from a main axis of the pulmonary artery cannula by an angle of between about 15 degrees and 90 degrees.

30. The system of claim 1, wherein a left atrial cuff of the lung is exposed to the lung chamber assembly for allowing the perfusion fluid to flow from the lung to the drain system.

31. The system of claim 1, wherein the disposable module further includes a includes a connection between a left atrial cuff and a cannula that directs the perfusion fluid from the lung to the drain system.

32. The system of claim 1, wherein the lung chamber assembly includes a housing, a support surface, and an openable lid.

33. The system of claim 32, wherein the support surface defines a drain and drainage channels for draining a perfusion fluid flowing out of the lung.

34. The system of claim 32, wherein the support surface is configured to secure a flexible wrap for providing support to and anchoring the lung.

35. The system of claim 34, wherein the flexible wrap comprises polyurethane.