IP Library Granted Patent US 12,317,888
Granted Patent B2
US 12,317,888 · App. 16/943,808 · Granted Jun 3, 2025

Systems and methods for ex vivo lung care

Inventors: Robert Fishman (Boston, MA); Robert Havener (Lynnfield, MA); Ihab Abdel Fattah (Andover, MA); Anas Abdelazim (North Andover, MA); Scott Newell (Ipswich, MA); Thomas H. Bishop (Wenham, MA); Tamer I. Khayal (North Andover, MA); Stanley Kyi (Andover, MA); Ronald Taylor, Jr. (Chester, NH); Doug Harriott (Melrose, MA); Matthew De Remer (Allston, MA); Paul Murray (Groton, MA); John Sullivan (Groton, MA); Mark Anderson (Danvers, MA); Richard Bringham (North Andover, MA); Michael Van Driel (Mirandola, IT); Waleed H. Hassanein (North Andover, MA)
Assignee: TRANSMEDICS, INC
A01N1/122A01N1/10A01N1/143
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Quick Facts
Patent No.
US 12,317,888
App. No.
16/943,808
Granted
Jun 3, 2025
Kind
B2
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 (23)

1. A system for evaluating an ex-vivo lung comprising:

an ex vivo perfusion circuit for circulating a perfusion fluid through an ex-vivo lung, the perfusion fluid entering the ex-vivo lung through a pulmonary artery interface and leaving the ex-vivo lung through a left atrial interface; and

a ventilation circuit for flowing a ventilation gas into and out of the ex-vivo lung through a tracheal interface;

the ex vivo perfusion circuit comprising a gas exchanger valve in fluid communication with a deoxygenation gas, and

the ventilation circuit comprising a trickle valve in fluid communication with the deoxygenation gas;

wherein the system is configured to deoxygenate the perfusion fluid until a predetermined first value of oxygen content in the perfusion fluid is reached and to reoxygenate the perfusion fluid by ventilating the ex-vivo lung with an oxygenation gas until a predetermined second value of the oxygen content in the perfusion fluid is reached, and

wherein the system is further configured to determine a condition of the ex-vivo lung based on a time taken for the ex-vivo lung to cause the perfusion fluid to change from the predetermined first value of the oxygen content to the predetermined second value of the oxygen content.

2. The system of claim 1 , wherein the system is configured to deoxygenate the perfusion fluid by ventilating the ex-vivo lung with the deoxygenation gas and wherein the deoxygenation gas comprises CO 2 and N 2 .

3. The system of claim 1 , wherein the ex vivo perfusion circuit further includes a gas exchange device, and the system is configured to deoxygenate the perfusion fluid by circulating the perfusion fluid through the gas exchange device while passing the deoxygenation gas comprising CO 2 and N 2 through the gas exchange device, the gas exchange device being adapted to remove oxygen from the perfusion fluid by gas exchange between the deoxygenation gas and the perfusion fluid.

4. A system for evaluating an ex-vivo lung comprising:

means for circulating a perfusion fluid through an ex-vivo lung, the perfusion fluid entering the ex-vivo lung through a pulmonary artery interface and leaving the ex-vivo lung through a left atrial interface, the means comprising a gas exchanger valve in fluid communication with a deoxygenation gas; and

means for flowing a ventilation gas into and out of the ex-vivo lung through a tracheal interface, the means comprising a trickle valve in fluid communication with the deoxygenation gas;

wherein the system is configured to deoxygenate the perfusion fluid until a predetermined first value of oxygen content in the perfusion fluid is reached and to reoxygenate the perfusion fluid by ventilating the ex-vivo lung with an oxygenation gas until a predetermined second value of the oxygen content in the perfusion fluid is reached, and wherein the system is further configured to determine a condition of the ex-vivo lung based on a time taken for the ex-vivo lung to cause the perfusion fluid to change from the predetermined first value of the oxygen content to the predetermined second value of the oxygen content.

5. A lung care system comprising:

an ex vivo perfusion circuit for circulating a perfusion fluid through an ex-vivo lung, the perfusion fluid entering the ex-vivo lung through a pulmonary artery interface and leaving the ex-vivo lung through a left atrial interface; and

a ventilation circuit for flowing a ventilation gas into and out of the ex-vivo lung through a tracheal interface;

the ex vivo perfusion circuit comprising a gas exchanger valve in fluid communication with a deoxygenation gas, and

the ventilation circuit comprising a trickle valve in fluid communication with the deoxygenation gas;

wherein the system includes a lung maintenance mode and a lung evaluation mode,

the lung maintenance mode being configured to ventilate the ex-vivo lung through the tracheal interface by flowing a captive volume of a ventilation gas back and forth between the ex-vivo lung and a variable volume chamber, and

the evaluation mode being configured to:

deoxygenate the perfusion fluid until a predetermined first value of oxygen content in the perfusion fluid is reached;

reoxygenate the perfusion fluid by ventilating the ex-vivo lung with an oxygenation gas until a predetermined second value of the oxygen content in the perfusion fluid is reached; and determine a condition of the ex-vivo lung based on a time taken for the ex-vivo lung to cause the perfusion fluid to change from the predetermined first value of the oxygen content to the predetermined second value of the oxygen content.

Assignments (2)
SECURITY INTEREST Recorded Jul 29, 2022
From: TRANSMEDICS, INC.
To: CANADIAN IMPERIAL BANK OF COMMERCE
Reel/Frame 060677/0520 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 13, 2020
From: ROBERT FISHMAN; HAVENER, ROBERT; ABDELAZIM, ANAS; NEWELL, SCOTT; BISHOP, THOMAS H; KHAYAL, TAMER; KYI, STANLEY; TAYLOR, RONALD, JR; HARRIOTT, DOUG; DE REMER, MATTHEW; MURRAY, PAUL; SULLIVAN, JOHN; ANDERSON, MARK; BRINGHAM, RICHARD; HASSANEIN, WALEED H; VAN DRIEL, MICHAEL; FATTAH, IHAB ABDEL
To: TRANSMEDICS, INC.
Reel/Frame 054365/0482 →