Systems and methods for ex vivo lung care

• US 8,420,380 B2
• Filed: 04/08/2008
• Issued: 04/16/2013
• Est. Priority Date: 01/31/2008
• Status: Active Grant

• Current Assignee: TransMedics, Inc. (TransMedics Group, Inc.)
• Original Assignee: TransMedics, Inc. (TransMedics Group, Inc.)
• Inventors: Fishman, Robert, Havener, Robert, Fattah, Ihab Abdel, Abdelazim, Anas, Newell, Scott, Bishop, Tom, Khayal, Tamer, Kyi, Stanley, Taylor, Ron, Harriott, Doug, De Remer, Matthew, Murray, Paul, Sullivan, John, Anderson, Mark, Bringham, Richard, Van Driel, Michael, Hassanein, Waleed
• Primary Examiner(s): HOBBS, MICHAEL L
• Application Number:
  US12/099,717
• Publication Number:
  US 20090197241A1
• Time in Patent Office: 1,834 Days
• Field of Search: 435/1.2, 435/284.1, 128/200.24, 128/898
• US Class Current: 435/284.1
• 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 system for preserving a lung ex vivo comprising:

a perfusion fluid circuit for 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;

a ventilation circuit for ventilating the lung through a tracheal interface, the ventilation circuit adapted to flow a captive volume of a ventilation gas back and forth between the lung and a variable volume chamber;

a trickle valve in fluid communication with the ventilation circuit for introducing into the captive volume an additional volume of the ventilation gas; and

a relief valve in fluid communication with the ventilation circuit for venting excess ventilation gas from the captive volume and for maintaining a minimum gas pressure of the captive volume; and

wherein a gas exchange in the lung between a component of the ventilation gas and the perfusion fluid causes the corresponding gas component in the perfusion fluid to reach an equilibrium value.

4. The system of claim 1, wherein the trickle valve is a one-way gas flow valve that only permits flow of a specific volume of gas into the system.

5. The system of claim 1, wherein the trickle valve permits continuous replacement of oxygen consumed by the lungs by permitting entry of ventilation gas into the system during each ventilation cycle.

6. The system of claim 1, wherein the relief valve includes a diaphragm;

and wherein the relief valve is controlled by applying a positive pressure to the diaphragm such that the relief valve remains open, and gas is vented to the outside, as long as the pressure in the ventilation circuit is greater than the pressure on the diaphragm.

10. The system of claim 1, wherein the tracheal interface includes a conduit by which air is introduced into the lung.

2. A system for preserving a lung ex vivo comprising:

means for 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;

means for ventilating the lung through a tracheal interface, a ventilation circuit adapted to flow a captive volume of a ventilation gas back and forth between the lung and a variable volume chamber;

means for introducing into the captive volume an additional volume of the ventilation gas; and

means for venting excess ventilation gas from the captive volume and for maintaining a minimum gas pressure of the captive volume, wherein a gas exchange in the lung between a component of the ventilation gas and the perfusion fluid causes the corresponding gas component in the perfusion fluid to reach an equilibrium value.

11. The system of claim 2, wherein the tracheal interface includes a conduit by which air is introduced into the lung.

3. A system for preserving a lung ex vivo comprising:

A pulmonary artery interface and a left atrial interface for circulating a perfusion fluid through the lung, wherein the fluid enters the lung through the pulmonary artery interface and leaves the lung through the left atrial interface;

a tracheal interface for ventilating the lung;

a ventilation circuit adapted to flow a captive volume of a ventilation gas back and forth between the lung and a variable volume chamber;

a first valve for introducing into the captive volume an additional volume of the ventilation gas; and

a second valve for venting excess ventilation gas from the captive volume and for maintaining a minimum gas pressure of the captive volume, wherein a gas exchange in the lung between a component of the ventilation gas and the perfusion fluid causes the corresponding gas component in the perfusion fluid to reach an equilibrium value.

7. The system of claim 3, wherein the pulmonary artery interface includes a pulmonary artery cannula, and wherein a portion of the pulmonary artery cannula is sized for being inserted into a pulmonary artery of the lung.

8. The system of claim 3, wherein the left atrial interface includes a sealed connection between a left atrium of the lung and a left atrial cannula.

9. The system of claim 3, wherein the tracheal interface includes a tracheal cannula, and wherein a portion of the tracheal cannula is sized for being inserted into a trachea of the lung.

12. The system of claim 3, wherein the tracheal interface includes a conduit by which air is introduced into the lung.