Systems and methods for ex vivo organ care

• US 8,535,934 B2
• Filed: 04/19/2007
• Issued: 09/17/2013
• Est. Priority Date: 04/19/2006
• Status: Active Grant

• Current Assignee: TransMedics, Inc. (TransMedics Group, Inc.)
• Original Assignee: TransMedics, Inc. (TransMedics Group, Inc.)
• Inventors: Hassanein, Waleed, Khayal, Tamer, Havener, Robert, Kyi, Stanley, Saleh, Hesham, Trachtenberg, Jon, Fattah, Ihab Abdel
• Primary Examiner(s): Bowers, Nathan
• Assistant Examiner(s): EDWARDS, LYDIA E
• Application Number:
  US11/788,865
• Publication Number:
  US 20080017194A1
• Time in Patent Office: 2,343 Days
• Field of Search: 4352831-3094
• US Class Current: 435/284.1
• CPC Class Codes: A01N 1/02 Preservation of living parts
• CPC Class Codes: A01N 1/0226 Physiologically active agents, i.e. substances affecting physiological processes of cells and tissue to be preserved, e.g. anti-oxidants or nutrients
• CPC Class Codes: A01N 1/0247 for perfusion, i.e. for circulating fluid through organs, blood vessels or other living parts
• CPC Class Codes: A61M 11/00 Sprayers or atomisers specially adapted for therapeutic purposes in general B05B; aerosol containers B65D83/14
• CPC Class Codes: A61M 11/042 electrical
• CPC Class Codes: A61M 16/0078 Breathing bags
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/10 Preparation of respiratory gases or vapours
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/0033 electrical
• CPC Class Codes: A61M 2016/1025 the O2 concentration
• CPC Class Codes: A61M 2016/103 the CO2 concentration
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide
• CPC Class Codes: A61M 2202/025 Helium
• CPC Class Codes: A61M 2202/0468 non-physiological
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/202 partial carbon oxide pressure, e.g. partial dioxide pressure (P-CO2)
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/432 : partial CO2 pressure (P-CO2)
• CPC Class Codes: G01N 33/4925 : measuring blood gas content, e.g. O2, CO2 , HCO3

Abstract

The invention, in various embodiments, provides systems, methods and solutions using an organ ex vivo.

Claims

1. A lung care system comprising:

a portable multiple use module including a portable chassis;

a first electromechanical connector disposed on the portable multiple use module;

a single use disposable module including;

a disposable structure including a second electromechanical connector disposed thereon that is sized and shaped for interlocking the single use disposable module with the multiple use module for electromechanical inter-operation with the multiple use module, wherein the second electromechanical connector is configured to electromechanically couple to the first electromechanical connector, and

a lung chamber assembly having a first interface for allowing a flow of perfusion fluid into the lung, a second interface for allowing ventilation of the lung, and a third interface for allowing a flow of the perfusion fluid away from the lung;

a pump adapted to flow the perfusion fluid into and away from the lung; and

a respiratory gas source having a predetermined composition of oxygen;

a ventilator coupled to the respiratory gas source and the second interface;

a gas exchange device configured to controllably alter a composition of a first gas component in the perfusion fluid;

at least one processor coupled to a non-transitory memory storing instructions that, when executed by the at least one processor;

cause the ventilator to ventilate the lung by flowing respiratory gas into the lung via the second interface in periodic breaths containing a predetermined volume of and pressure of the respiratory gas;

cause the ventilator to maintain a predetermined minimum positive end-expiratory pressure, and

cause the gas exchange device to modulate the composition of the first gas component in the perfusion fluid as a function of the amount of oxygen in the respiratory gas provided to the lung;

wherein the lung chamber assembly includes a flexible membrane that suspends the lung within the lung chamber assembly for supporting the lung and maintaining a shape of the lung.

2. The system of claim 1, wherein the first interface includes a pulmonary artery cannula, and the second interface includes a cannula disposed within a tracheal conduit of the lung.

3. The system of claim 1, wherein the third interface includes a cup shaped interface and the cup-shaped interface includes a plurality of openings at respective heights along a sidewall of the interface.

4. The system of claim 3, wherein the third interface includes a selector valve in fluid communication with the plurality of openings for controllably drawing the perfusion fluid in the cup-shaped interface away from the lung chamber assembly via a selected one of the plurality of openings and an outlet conduit.

5. The system of claim 1, wherein the flexible membrane substantially prevents the lung from contacting at least one wall of the lung chamber assembly.

6. The system of claim 1, wherein the flexible membrane is a netting.

7. The system of claim 1, wherein the lung chamber assembly has a shape of a ribcage.

8. The system of claim 1, wherein the lung chamber assembly includes a diaphragm structure.

9. The system of claim 1, comprising a heater for maintaining the perfusion fluid provided to the lung chamber assembly at a near physiologic temperature.

10. The system of claim 9, wherein the temperature is between about 30°

C. and about 37°

C.

11. The system of claim 10, wherein the temperature is between about 34°

C. and about 37°

C.

12. The system of claim 1, wherein the gas exchange device includes a gas select switch for selecting from a plurality of gas supplies to modulate the composition of a gas component in the perfusion fluid.

13. The system of claim 1, comprising an isolated volume compartment cannulated to a tracheal conduit of the lung and adapted to ventilate the lung during perfusion.

14. The system of claim 1, comprising an oxygenation sensor for measuring an oxygen content in the perfusion fluid.

15. The system of claim 1, comprising an oxygenation sensor adapted to provide a signal indicative of a hematocrit measurement of the perfusion fluid.

18. The system of claim 1 wherein the single use disposable module further includes an optical interconnection configured to be coupled to a corresponding connection on the multiple use module.

16. A lung care system comprising:

a portable multiple use module including a portable chassis;

a first electromechanical connector disposed on the portable multiple use module;

a single use disposable module including,

a disposable structure including a second electromechanical connector disposed thereon that is sized and shaped for interlocking the single use disposable module with the multiple use module for electromechanical inter-operation with the multiple use module, wherein the second electromechanical connector is configured to electromechanically couple to the first electromechanical connector, and

a lung chamber assembly having a first conduit for allowing a flow of perfusion fluid into the lung, a second conduit for allowing ventilation of the lung, and a third conduit for allowing a flow of the perfusion fluid away from the lung;

a pump adapted to flow the perfusion fluid into and away from the lungs; and

a respiratory gas source in communication with the second conduit;

a ventilator coupled to the respiratory gas source and the second conduit;

a gas exchange device configured to controllably alter a composition of a first gas component in the perfusion fluid; and

at least one processor coupled to a non-transitory memory storing instructions that, when executed by the at least one processor;

cause the ventilator to ventilate the lung by flowing respiratory gas into the lung via the second conduit in periodic breaths containing a predetermined volume of and pressure of the respiratory gas;

cause the ventilator to maintain a predetermined minimum positive end-expiratory pressure, and

cause the gas exchange device to modulate the composition of the first gas component in the perfusion fluid as a function of the amount of oxygen in the respiratory gas provided to the lung;

a perfusion circuit in communication with the first and third conduits wherein the third conduit is configured to connect to pulmonary veins of a lung and a left atrial cuff.

17. The system of claim 16, wherein the third conduit has a funnel shaped end.

19. The system of claim 16 wherein the single use disposable module further includes an optical interconnection configured to be coupled to a corresponding connection on the multiple use module.