Portable perfusion/oxygenation module having mechanically linked dual pumps and mechanically actuated flow control for pulsatile cycling of oxygenated perfusate

• US 5,965,433 A
• Filed: 05/29/1996
• Issued: 10/12/1999
• Est. Priority Date: 05/29/1996
• Status: Expired due to Fees

• Current Assignee: Microbiomed Corp., Organ Transport Systems, Inc. (SK3 Group, Inc.)
• Original Assignee: Trans Data Service Incorporated
• Inventors: Gardetto, William W., Matthews, James L., Heacox, John K.
• Primary Examiner(s): Redding, David A.
• Application Number:
  US08/652,696
• Time in Patent Office: 1,231 Days
• Field of Search: 435/284.1, 435/286.1, 435/286.6, 422/44, 422/45, 422/48
• US Class Current: 435/284.1
• CPC Class Codes: A01N 1/02 Preservation of living parts
• CPC Class Codes: A01N 1/0247 for perfusion, i.e. for circulating fluid through organs, blood vessels or other living parts

Abstract

A portable perfusion/oxygenation module includes respiratory gas driven dual positive displacement pumps coupled to a stacked membrane oxygenator unit for perfusion fluid oxygenation, a valving manifold to control perfusate flow-direction coupled to an organ chamber designed to enable easy installation of organ and maintenance of intra and extra organ fluid pressure. All of the components and oxygen cylinders are fitted into an insulated chest capable of sustaining perfusion and oxygenation for 24 hours. The perfusion/oxygenation apparatus requires no electrical power, is compact with the total weight including the perfusion fluids and organ weighing less than 50 pounds. With low cumulative weight and the extremely low flow rate of gas required to pump the perfusate, the oxygen supply is capable of sustaining pumping operation for 24 hours without gas cylinder change. The dual pumps have axially aligned, commonly connected pistons using adjustable linkages that provide a simple and robust means of adjusting perfusate volume and pumping rate. No movable membranes, diaphragms or electrical power are required to deliver oxygenated perfusate.

Claims

1. Perfusion apparatus of the type including a sealed chamber for administering oxygenated perfusate into an organ, an oxygenator having a perfusate supply port for receiving liquid perfusate and an oxygen supply port for receiving pressurized oxygen;

a positive displacement pump having a compressed gas chamber and a perfusate reservoir chamber separated by a movable piston, a linear actuator having a compressed gas chamber, a piston movable through the compressed gas chamber;

a piston rod connecting the pump piston and the actuator piston together for concurrent stroking movement;

a control valve having a supply port for receiving compressed oxygen from a supply and first and second outlet ports coupled to the compressed oxygen chambers of the pneumatic actuator and the perfusate pump, respectively, and an actuator arm coupled to the common piston rod for switching the supply port in flow communication with the first and second outlet control valve outlet ports in response to forward and reverse stroking movement of the commonly connected piston rods, respectively;

first and second supply conduits connecting the first and second control valve outlet ports in flow communication with the oxygen chamber of the oxygenator;

a supply conduit connecting the perfusate reservoir chamber of the pump in flow communication with the perfusate chamber of the oxygenator;

a first return conduit connecting the sealed organ chamber in flow communication with the perfusate reservoir chamber of the pump; and

a second return conduit connecting the sealed organ chamber in flow communication with the oxygenator perfusate chamber.

2. Perfusion apparatus of the type having a sealed chamber for receiving an organ and an oxygenator having a perfusate supply port for receiving liquid perfusate, and an oxygen supply port for receiving pressurized oxygen, and a membrane for transferring the oxygen into the liquid perfusate, said oxygenator having first and second oxygenation compartments, the first and second oxygenation compartments being divided by first and second oxygen permeable membranes, respectively, thereby defining a perfusate chamber and an oxygen chamber in each compartment, respectively, wherein the oxygen chambers are connected in flow communication with the oxygen supply port and the perfusate chambers are connected in flow communication with each other, the first perfusate chamber being connected in flow communication with the perfusate supply port and the second perfusate compartment being connected in flow communication with the sealed organ chamber.

3. Perfusion apparatus of the type including a sealed container for perfusing an organ with liquid perfusate solution and an oxygenator having an oxygen chamber and a perfusate chamber for transferring oxygen from a supply of compressed oxygen to the perfusate solution before the perfusate solution is administered to the organ, characterized by:

first and second positive displacement pumps each having a compressed gas chamber and a reservoir chamber separated by a movable piston, the pistons of the first and second pumps each having piston rods commonly connected for concurrent stroking movement, a control valve having a supply port, first and second outlet ports and an actuator for selectively directing pressurized oxygen into the compressed gas chambers of the first and second pumps, respectively, in response to shifting movement of the actuator, shifting apparatus coupled between the actuator and the commonly connected pistons for shifting the actuator in the direction of piston stroke movement, first and second power conduits connecting the first and second control valve outlet ports in flow communication with the compressed gas chambers of the first and second pumps, respectively, first and second supply conduits connecting the first and second control valve outlet ports in flow communication with the oxygen chamber of the oxygenator, a first return conduit connecting the oxygenator perfusate in flow communication with the pump perfusate reservoir chamber, and a second return conduit connecting the organ container chamber in flow communication with the pump perfusate reservoir chamber.

4. Self-contained, portable perfusion apparatus comprising, in combination:

a portable supply of compressed gas;

first and second positive displacement pumps, each pump having a cylindrical bore, a piston movable through the cylindrical bore thereby dividing the cylindrical bore into a compressed gas chamber and a perfusate reservoir chamber, and a piston rod attached to the piston and projecting through the reservoir chamber of each pump, respectively, the piston rods being connected together for concurrent stroking movement;

a control valve having a supply port connected to the compressed gas supply, a first outlet port and a second outlet port, and an actuator for switching the supply port in flow communication with the first outlet port in response to shifting movement of the actuator to a first position, and for switching the supply port in flow communication with the second outlet port in response to shifting movement of the actuator to a second position;

shifting apparatus movably coupled to the control valve actuator arm and to the connected piston rods for shifting the actuator in the direction of piston stroking movement;

an organ container having a sealed chamber for receiving an organ;

an oxygenator assembly having an oxygen chamber, a perfusate chamber, an oxygen permeable membrane separating the oxygen chamber and the perfusate chamber, and a delivery tube connecting the perfusate chamber in flow communication with the organ chamber;

first and second power conduits connecting the first and second control valve outlet ports in flow communication with the compressed gas chambers of the first and second pumps, respectively;

first and second supply conduits connecting the first and second control valve outlet ports in flow communication with the oxygen chamber of the oxygenator;

a first return conduit connecting the organ chamber in flow communication with the pump perfusate reservoir chamber; and

,

a second return conduit connecting the organ chamber of the oxygenator in flow communication with the oxygenator perfusate reservoir chamber.

5. A self-contained, portable perfusion apparatus comprising, in combination:

a portable supply of compressed oxygen;

a sealed chamber for administering oxygenated perfusate into an organ;

an oxygenator having a perfusate supply port for receiving liquid perfusate and an oxygen supply port for receiving compressed oxygen;

a positive displacement pump having a compressed chamber and a perfusate reservoir chamber separated by a movable piston;

a pneumatic actuator having a compressed gas chamber and a piston movable through the compressed gas chamber;

a piston rod connecting the pump piston to the pneumatic actuator piston thereby providing concurrent stroking movement of the pistons;

a control valve having a supply port coupled to the compressed oxygen supply and having first and second outlet ports coupled to the compressed oxygen chambers of the perfusate pump and the pneumatic actuator, respectively, and having an actuator arm coupled to the common piston rod for switching the supply port in flow communication with the first and second control valve outlet ports in response to forward and reverse stroking movement of the commonly connected pistons, respectively;

first and second supply conduits connecting the first and second control valve outlet ports in flow communication with the oxygen chamber of the oxygenator;

a supply conduit connecting the pump perfusate reservoir chamber in flow communication with the oxygenator perfusate chambers;

a first return conduit connecting the sealed organ chamber in flow communication with pump perfusate reservoir chamber; and

,

a second return conduit connecting the sealed organ chamber in flow communication with the oxygenator perfusate chamber.

6. A self-contained, portable perfusion apparatus comprising, in combination:

a portable supply of compressed oxygen;

a positive displacement pump having a bore, a piston movable through the bore thereby dividing the bore into a compressed gas chamber and a perfusate reservoir chamber;

a pneumatic actuator having a bore and a piston movable through the bore thereby defining a movable boundary for the compressed gas chamber;

a piston rod attached to the pump piston and the actuator piston thereby providing concurrent piston stroking movement;

a control valve having a supply port connected to the portable oxygen supply and having first and second outlet ports coupled to the compressed oxygen chambers of the pneumatic actuator and the perfusate pump;

respectively;

the control valve having a actuator arm for switching the supply port in flow communication with the first valve outlet port in response to shifting movement of the actuator arm to a first position, and for switching the supply port in flow communication with the second valve outlet port in response to shifting movement of the actuator arm to a second position;

shifting apparatus movably coupled to the control valve actuator arm and to the common piston rod for shifting the actuator arm to the first position and to the second position in response to forward and reverse stroking movement of the commonly connected pistons, respectively;

a oxygenator having an oxygen chamber, a perfusate chamber and an oxygen permeable membrane for transferring oxygen into the perfusate chamber;

a sealed container for administering oxygenated perfusate into an organ contained within the sealed organ chamber;

power conduits connecting the first and second control valve outlet ports in flow communication with the compressed gas chambers of the pneumatic actuator and perfusate pump, respectively;

supply conduits connecting the first and second valve outlet ports in flow communication with the oxygen chamber of the oxygenator;

a supply conduit connecting the pump perfusate reservoir in flow communication with the oxygenator perfusate chamber; and

first and second return conduits connecting the organ chamber in flow communication with the pump perfusate reservoir and the oxygenator perfusate chamber, respectively.

7. Self-contained, portable perfusion apparatus comprising, in combination:

a portable supply of compressed oxygen;

a sealed chamber for administering oxygenated perfusate into an organ;

an oxygenator having perfusate supply port for receiving liquid perfusate and an oxygen supply port for receiving compressed oxygen;

a positive displacement pump having a compressed gas chamber and a perfusate reservoir chamber separated by a movable piston;

a pneumatic actuator having a compressed gas chamber and vent chamber separated by a movable piston;

the pump piston and the actuator piston having piston rods connected together for concurrent stroking movement;

a control valve having a supply port for receiving compressed oxygen from the portable supply and first and second outlet ports coupled to the compressed oxygen chamber of the pneumatic actuator and the perfusate pump, respectively, and an actuator arm coupled to the commonly connected piston rods for switching the supply port in flow communication with the first and second control valve outlet ports in response to forward and reverse stroking movement of the commonly connected piston rods, respectively;

first and second supply conduits connecting the first and second control valve outlet ports in flow communication with the oxygen chamber of the oxygenator;

a supply conduit connecting the pump reservoir chamber in flow communication with the oxygenator perfusate chamber;

a first return conduit connecting the sealed organ chamber in flow communication with the pump reservoir chamber; and

a second return conduit connecting the sealed organ chamber in flow communication with the oxygenator perfusate chamber.

8. A self-contained, portable perfusion apparatus comprising, in combination:

a portable supply of compressed gas;

a positive displacement pump having a cylindrical bore, a piston movable through the cylindrical bore thereby dividing the cylindrical bore into compressed gas chamber and a perfusate reservoir chamber, and a piston rod attached to the piston and projecting out of the perfusate reservoir chamber;

a linear actuator having a cylindrical bore, a piston movable through the cylindrical bore thereby defining a movable boundary of the compressed gas chamber;

a piston rod attached to the piston and projecting out of the vent chamber;

a piston rod connecting the linear actuator piston to the pump piston for concurrent stroking movement;

a control valve having a supply port connected to the portable oxygen supply and having first and second outlet ports coupled to the compressed oxygen chambers of the linear actuator and pump, respectively;

the control valve having an actuator arm for switching the supply port in flow communication with the first outlet port in response to shifting movement of the actuator to a first position, and for switching the supply port in flow communication with the second outlet port in response to shifting movement of the actuator to a second position;

shifting apparatus movably coupled to the control valve actuator arm and to the common piston rod for shifting the actuator arm to the first position and to the second position in response to forward and reverse stroking movement, respectively;

an oxygenator having an oxygen chamber, a profusate chamber and a membrane for transferring oxygen into the perfusate chamber;

a sealed container for administering oxygenated perfusate into an organ;

power conduits connecting the first and second control valve outlet ports in flow communication with the compressed gas chambers of the linear actuator and the pump, respectively;

supply conduits connecting the first and second control valve outlet ports in flow communication with the oxygenator oxygen chamber;

a supply conduit connecting the pump perfusate reservoir in flow communication with the oxygenator perfusate chamber; and

,

first and second return conduits connecting the organ chamber in flow communication with the pump perfusate reservoir and the oxygenator perfusate reservoir, respectively.

9. A self-contained, portable organ perfusion apparatus comprising a portable supply of compressed oxygen;

an oxygenator having an oxygen chamber, a perfusate chamber and a membrane separating the oxygen chamber and the perfusate chamber;

a sealed organ container having a chamber for receiving an organ and a volume of liquid perfusate solution;

a positive displacement pump having a compressed oxygen chamber, a perfusate reservoir chamber and a piston separating the oxygen chamber and the perfusate reservoir chamber;

a pneumatic actuator having a compressed oxygen chamber and a piston defining a movable boundary for the compressed oxygen chamber;

a piston rod connecting the actuator piston and the pump piston for concurrent stroking movement;

a control valve having a supply port connected in flow communication with the portable oxygen supply, first and second outlet ports connected in flow communication with the compressed oxygen chambers of the pneumatic actuator and the perfusate pump, respectively, and a control valve actuator arm for switching the supply port in flow communication with the first outlet port and the second outlet port in response to forward and reverse shifting movement, respectively; and

,

shifting apparatus coupled to the control valve actuator and to the piston rod for shifting the actuator to the first operating position and to the second operating position in response to forward and reverse stroking movement of the commonly connected pistons, respectively.

10. A self-contained, portable organ perfusion apparatus as defined in claim 9, the shifting apparatus including:

over-centered toggle linkage movably coupled to the actuator arm for rapidly shifting the actuator arm in response to stroking movement of the commonly connected pistons.

11. A self-contained, portable organ perfusion apparatus as defined in claim 9, said oxygenator having first and second oxygenation compartments, the first and second oxygenation compartments being divided by first and second oxygen permeable membranes, respectively, thereby defining a perfusate chamber and an oxygen chamber in each compartment, respectively, the oxygen chambers being connected in flow communication with the oxygen supply port and the perfusate chambers being connected to receive liquid perfusate from the pump reservoir during a charging stroke of the commonly connected pistons, and the perfusate chambers of the oxygenator being coupled to the sealed organ chamber in response to a return stroke of the commonly connected pistons.

12. A self-contained, portable organ perfusion apparatus as defined in claim 11, the over-centered toggle linkage comprising first and second bails disposed on opposite sides of the actuator arm and being mounted for pivotal movement toward and away from the actuator arm, and including first and second tension springs coupled to the first and second bails for urging the bails to move in the direction of piston stroking movement.