WO1997045527A1 - Portable perfusion/oxygenation module having respiratory gas driven, mechanically linked dual pumps and mechanically actuated flow control valve for slow pulsatile cycling of oxygenated perfusate during in vitro conservation of viable transplant organs - Google Patents
Portable perfusion/oxygenation module having respiratory gas driven, mechanically linked dual pumps and mechanically actuated flow control valve for slow pulsatile cycling of oxygenated perfusate during in vitro conservation of viable transplant organs Download PDFInfo
- Publication number
- WO1997045527A1 WO1997045527A1 PCT/US1997/009000 US9709000W WO9745527A1 WO 1997045527 A1 WO1997045527 A1 WO 1997045527A1 US 9709000 W US9709000 W US 9709000W WO 9745527 A1 WO9745527 A1 WO 9745527A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- chamber
- perfusate
- oxygen
- organ
- flow communication
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0236—Mechanical aspects
- A01N1/0242—Apparatuses, i.e. devices used in the process of preservation of living parts, such as pumps, refrigeration devices or any other devices featuring moving parts and/or temperature controlling components
- A01N1/0247—Apparatuses, i.e. devices used in the process of preservation of living parts, such as pumps, refrigeration devices or any other devices featuring moving parts and/or temperature controlling components for perfusion, i.e. for circulating fluid through organs, blood vessels or other living parts
Definitions
- TITLE PORTABLE PERFUSION/OXYGENATION MODULE HAVING RESPIRATORY GAS DRIVEN, MECHANICALLY LINKED DUAL PUMPS AND MECHANICALLY ACTUATED FLOW CONTROL VALVE FOR SLOW PULSATILE CYCLING OF OXYGENATED PERFUSATE DURING IN VITRO CONSERVATION OF VIABLE TRANSPLANT ORGANS
- the present invention is related generally to organ preservation, and in particular to highly portable, nonelectric perfusion apparatus for administering a chilled, oxygenated nutrient solution through the vascular bed of an organ following excision of the organ.
- perfused, oxygenated and nutrient-balanced salt solutions at a reduced temperature enhances the viability of the transplant organ in several ways: lowering of the perfusion fluid and organ temperature lowers the metabolic activity of the organ's cells and hence reduces the demand for physiologic oxygen levels and consumption of nutrients. Reduction in cell metabolism also reduces the rate of production of by-products of metabolism such as C0 2 and lactic acid, thus further reducing tissue damage and stabilizing perfusate pH and osmotic balance. Lowering of the temperature reduces the demand for oxygen and hence protects against inadequate oxygen levels that could result in ischemic tissue.
- oxygen transport is enhanced as a consequence of the hemoglobin in red blood cells serving to load, transport, and unload the oxygen in tissues of lower oxygen concentration.
- perfusion fluids typically do not contain red blood cells
- oxygen transportation is a function of the direct solubility of the gas phase (oxygen) in the perfusate solution, also being dependent upon the partial pressure of 'the gas phase driving gas in the liquid perfusate.
- satisfactory oxygen transport is achieved by exposing the perfusate to a gas phase under pressure, the pressure available being limited by the design of the oxygenating chamber and also by the limits of perfusion pressure that- can be applied within the vessels of the perfused organ without causing damage.
- the solubility of oxygen in water under low partial pressure is adequate to supply celltissue needs for maintenance oxygen levels.
- O'Dell and Gunegin Patent 5,362,622, Patent 5,385,821 and O'Dell Patent 5,356,771 describe an organ perfusion system that employs either a fluidic logic device or a gas pressure driven ventilator pump to cyclically deliver gas to a sealed chamber connected to the top of the canister containing the organs.
- Cyclical, delivery of gas under pressure to the upper sealed chamber serves to displace a semi-permeable membrane mounted between the gas chamber and the fluid containing organ canister. Cyclical membrane displacement serves to transduce the gas pressure into fluid displacement on 'the opposite side, thus providing flow of the perfusate solution.
- the membrane is selected for its permeability to gas but not to water, permitting oxygen or other gas mixtures to be driven through the membrane into the perfusate or 5 alternatively to vent C0 2 from the perfusate.
- the intent of such membrane pump devices was to provide a system that used no electricity, used low gas pressure and volumes to achieve perfusate flow, had few moving parts, provided adequate perfusate oxygenation, that could be operated in non-upright positions, that isolated the organ and perfusate from atmosphere, and as a total package, was of compact size and reduced weight to permit portability. ⁇ o Although these designs have proved functional in experimental settings where portability was not necessary, these membrane pumps failed to meet the criteria claimed by the developers. For example, the transducing permeable membrane requires large volumes of gas to transduce the energy into fluid movement, with each cycle requiring several ml of gas to achieve a fluid displacement of 30-60 ml/stroke. Extrapolation of these performance
- the apparatus is further compromised by a multiple clamping system for canister lid fixation and sealing, necessary to sustain pressure differential for pumping, consisting of silastic gels, with no design provision to assure against compartment leaks.
- the canister flow design attempts to pulse perfusate both within the perfused organ and around the outside of the organ in an attempt to saturate the organ with freshly oxygen-
- the present invention provides an apparatus and method that fulfills these essential criteria, namely, the irate of oxygen utilization allows two 250 liter cylinders to supply at least twenty-four hours of perfusion time, the entire apparatus its into a standard styrofoam ice chest, is readily portable by one person, uses a simple mechanical drive, and has been shown to maintain human and animal hearts for 18 hours or more with no deleterious effect to the perfused and transplanted organ.
- the perfusion apparatus of the present invention utilizes dual positive displacement pumps having pistons interconnected in a push-push configuration.
- the positive displacement pistons aye stroked by pressurized oxygen, with liquid perfusate being pumped through an oxygenator and into the vascular bed of a donor organ during one piston power stroke.
- Perfusate that drains from the donor organ is collected in a sealed container and returned to the perfusate pump reservoir in response to a power stroke by the other pump.
- Pressurized oxygen from a portable supply is alternately directed to the pressurized gas chambers of the first and second pumps by a two port, double-throw flow control valve.
- the outlet ports of the double-throw control valve are selected by an actuator arm that is mechanically coupled to the commonly connected piston rods of the dual pumps.
- the supply port is switched between the outlet ports in response to shifting movement of the actuator arm.
- the actuator arm is shifted forward and reverse in response to forward and reverse stroking movement of the commonly connected piston rods.
- the valve actuator arm is engagable by over-center toggle linkage actuators that are spring-biased for rapid shifting movement away from an overcenter neutral position in response to forward and reverse piston stroke movement.
- the two-port, doublethrow control valve, dual pistons and over-center toggle linkage operate in a free-running, astable multi-vibrator mode of operation.
- the pistons stroke in a reciprocal push-push arrangement that continuously supplies oxygen to the oxygenator, while slowly discharging perfusate through the oxygenator and into the organ at a first pressure level corresponding approximately to systolic pressure during the first stroke, and then returning spent perfusate collected in the organ container back into the peyfusate pump reservoir and into the oxygenator at a second pressure level corresponding approximately to diastolic pressure during the second stroke.
- the inlet oxygen pressure to the pistons is adjusted to provide relatively slow charge and return, with systolic/diastolic pressure strokes cycling in the range of about 1.5 to about 2 strokes per minute.
- FIGURE 1 is a simplified hydraulic circuit diagram showing the interconnection of 'the principal components of a portable perfusion apparatus of the present invention
- FIGURE 2 is an elevational view, partially broken away and partially in section, showing a donor organ suspended within an organ container and coupled to an oxygenator for receiving freshly oxygenated perfusate;
- FIGURE 3 is a side elevational view thereof, with ice packs surrounding the organ container;
- FIGURE 4 is a top plan view thereof
- FIGURE 5 is a simplified pneumatic and hydraulic diagram which illustrates the interconnection of dual, positive displacement pumps having piston rods commonly connected in a push-push arrangement for charging the oxygenator with perfusate and returning spent perfusate to the primary pump;
- FIGURE 6 is a top plan view of -the dual pump combination shown in FIGURE 5, which illustrates details of a springbiased, over-center toggle linkage valve actuating apparatus; and, FIGURE 7 is a graph illustrating the time variation of systolic and diastolic pressure of oxygenated perfusate that is administered through the vascular bed of the organ shown in FIGURE 2.
- the combination perfusion/oxygena- tion apparatus 10 of the present invention provides chilled, oxygenated perfusate at a slow delivery rate for nourishing and conserving a viable, human heart 12.
- the exemplary embodiment features a human heart
- other organs that have an identifiable vascular system for carrying blood with separate in-flow and out-flow vessels can be nourished and maintained in a viable condition by the perfuming apparatus of the present invention, for example kidneys, livers, thyroids, lungs, intestines, pancreas reproductive organs, brains, spleens, as well as severed limbs and the like.
- the perfuming apparatus 10 can be used for conserving organs and body parts of test animals such as mice, rats, dogs and cats, provided that the vascular in-flow vessel of the animal organ is sufficiently large to attach onto a fluid conduit.
- the perfusion apparatus 10 of the present invention includes a paiy of compressed oxygen cannisters connected in parallel thereby defining a portable oxygen supply 14, an oxygenator assembly 16, an organ container 18 having a sealed chamber 20, a pneumatic actuator 22, a positive displacement pump 24, a flow control valve 26 and a mechanical switching assembly 28 for actuating the control valve 26.
- the oxygen supply 14 is coupled to the control valve 26 through a pressure regulator 30, a supply conduit 32 and a float regulator 34.
- the compresse oxygen supply has a capacity of approximately 450 liters of respirable oxygen. Compressed oxygen is conducted -through the control valve to the pneumatic actuator, the positive displacement pump and the oxygenator.
- the oxygenator has first and second oxygenator compartments 36, 38 that are divided by first and second oxygen permeable membranes 40, 42, respectively, thereby defining an oxygen chamber 44 and a perfusate chamber 46 in the first oxygenator compartment 36, and defining an oxygen chamber 48 and a perfusate chamber 50 in the second oxygenator compament 38.
- the oxygen chambers 44, 48 are connected in flow communication with each other and with an oxygen supply part 52 by a bore 54.
- the perfusate chambers 46,50 are connected in flow communication with each other by a bypass tube 56.
- the perfusate chamber is connected in flow communication with a perfusate supply port 58, and the perfusate chamber 50 is connected in flow comunication with the sealed organ chamber 20 through a delivery tube
- the oxygenated perfusate 62 id discharged into the vascular bed of the organ 12, in this instance a human heart, through the aorta and into an artery that bypasses the aorta valve, into the capillary vessels that nourish the heart muscle tissue.
- the organ chamber is cooled by ice packs 64 that surround the organ container 18.
- the pneumatic actuator has a cylindrical bore 66 and a piston 68 that moves axially through the bore, thereby defing a compressed gas chamber 69.
- the pump 24 has a cylindrical bore 70 and a piston 72 that is axially movable through the bore, thereby defining a compressed gas chamber 74 and a perfusate chamber 76.
- a piston rod 76 connects the pistons 68, 72 together fer concurrent stroking movement.
- the control valve 26 has a supply port S connnected to the compresed oxygen supply 14 and f irst and second outlet ports A,B coupled to the compressed gas chambers 69,76 of the pneumatic actuator and the pump 24, respectiely.
- An actuator arm 78 is coupled to the common piston rod 76 for switching the supply port S in flow co unica-tion with the first and second control valve out-let ports A,B in response to forward and reverse stroking movement of the commonly connected pistons.
- First and second supply conduits 80, 82 connect the outlet ports A,B in flow communication with the compressed gas chambers 69,76 of the pneumatic actuator and the pump, respectively.
- a supply conduit 82 connects the perfuseate reservoir chamber 76 of the pump in f low communication with the perfusate chamber supply port 58, and a first return conduit 84 connects 'the sealed organ chamber in f low communication with the perfusate reservoir chanber supply port 52.
- a second return conduit 86 connects the organ chamber in flow communication with the oxygenator perfusate supply port 58.
- An oxygen supply conduit 88 and a supply conduit 90 connect the oxygen supply port to the oxygenator.
Abstract
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP97925738A EP0842261A1 (en) | 1996-05-29 | 1997-05-28 | Portable perfusion/oxygenation module having respiratory gas driven, mechanically linked dual pumps and mechanically actuated flow control valve for slow pulsatile cycling of oxygenated perfusate during in vitro conservation of viable transplant organs |
AU30787/97A AU3078797A (en) | 1996-05-29 | 1997-05-28 | Portable perfusion/oxygenation module having respiratory gas driven, mechanically linked dual pumps and mechanically actuated flow control valve for slow pulsatile cycling of oxygenated perfusate during in vitro conservation of viable transplant organs |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/652,696 US5965433A (en) | 1996-05-29 | 1996-05-29 | Portable perfusion/oxygenation module having mechanically linked dual pumps and mechanically actuated flow control for pulsatile cycling of oxygenated perfusate |
US08/652,696 | 1996-05-29 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1997045527A1 true WO1997045527A1 (en) | 1997-12-04 |
Family
ID=24617794
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1997/009000 WO1997045527A1 (en) | 1996-05-29 | 1997-05-28 | Portable perfusion/oxygenation module having respiratory gas driven, mechanically linked dual pumps and mechanically actuated flow control valve for slow pulsatile cycling of oxygenated perfusate during in vitro conservation of viable transplant organs |
Country Status (5)
Country | Link |
---|---|
US (1) | US5965433A (en) |
EP (1) | EP0842261A1 (en) |
CA (1) | CA2228422A1 (en) |
MX (1) | MX9801137A (en) |
WO (1) | WO1997045527A1 (en) |
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1996
- 1996-05-29 US US08/652,696 patent/US5965433A/en not_active Expired - Fee Related
-
1997
- 1997-05-28 EP EP97925738A patent/EP0842261A1/en not_active Withdrawn
- 1997-05-28 WO PCT/US1997/009000 patent/WO1997045527A1/en not_active Application Discontinuation
- 1997-05-28 CA CA002228422A patent/CA2228422A1/en not_active Abandoned
-
1998
- 1998-02-10 MX MX9801137A patent/MX9801137A/en unknown
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US3632473A (en) * | 1969-04-21 | 1972-01-04 | Univ California | Method and apparatus for preserving human organs extracorporeally |
US3639084A (en) * | 1970-04-06 | 1972-02-01 | Baxter Laboratories Inc | Mechanism for control pulsatile fluid flow |
US5385821A (en) * | 1993-03-11 | 1995-01-31 | Board Of Regents, The University Of Texas System | Method for hypothermic preservation of living tissue |
Cited By (14)
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WO2000018226A2 (en) * | 1998-09-29 | 2000-04-06 | Organ Recovery Systems, Inc. | Apparatus and method for maintaining and/or restoring viability of organs |
WO2000018226A3 (en) * | 1998-09-29 | 2000-05-25 | Life Science Holdings Inc | Apparatus and method for maintaining and/or restoring viability of organs |
US8962303B2 (en) | 1998-09-29 | 2015-02-24 | Lifeline Scientific, Inc. | Apparatus and method for maintaining and/or restoring viability of organs |
US8361091B2 (en) | 2002-08-23 | 2013-01-29 | Organ Recovery Systems, Inc. | Cannulas, cannula mount assemblies, and clamping methods using such cannulas and cannula mount assemblies |
WO2009132018A1 (en) | 2008-04-22 | 2009-10-29 | The Board Of Regents Of The University Of Texas System | Fluidics-based pulsatile perfusion organ preservation device |
EP2278874A4 (en) * | 2008-04-22 | 2017-02-08 | The Board of Regents of The University of Texas System | Fluidics-based pulsatile perfusion organ preservation device |
US9022978B2 (en) | 2011-04-29 | 2015-05-05 | Lifeline Scientific, Inc. | Universal sealring cannula |
US8828034B2 (en) | 2011-04-29 | 2014-09-09 | Lifeline Scientific, Inc. | Cannula |
US9642625B2 (en) | 2011-04-29 | 2017-05-09 | Lifeline Scientific, Inc. | Cannula for a donor organ with or without an aortic cuff or patch |
RU2617093C1 (en) * | 2016-03-16 | 2017-04-19 | Общество С Ограниченной Ответственностью "Биософт-М" | Perfusion circuit pump drive unit for restoration of blood circulation and oxygenation |
WO2017160191A1 (en) * | 2016-03-16 | 2017-09-21 | Игорь Алексеевич Филатов | Device for driving a perfusion circuit pump for restoring blood circulation and blood oxygenation |
EA037943B1 (en) * | 2016-03-16 | 2021-06-10 | Общество С Ограниченной Ответственностью "Биософт-М" | Device for driving a perfusion circuit pump for restoring blood circulation and blood oxygenation |
RU185905U1 (en) * | 2018-06-29 | 2018-12-21 | Акционерное общество "Научно-производственное объединение "СПЛАВ" | Automated device for emergency restoration of blood circulation |
WO2021122346A1 (en) * | 2019-12-20 | 2021-06-24 | Corlife Ohg | Container, closure lid, and vessel for transplant objects, and methods and systems for providing three-dimensional structure data and for sterilizing a transplant object |
Also Published As
Publication number | Publication date |
---|---|
CA2228422A1 (en) | 1997-12-04 |
US5965433A (en) | 1999-10-12 |
EP0842261A1 (en) | 1998-05-20 |
MX9801137A (en) | 1998-11-29 |
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