Abstract:
Apparatus and method for preserving an organ via perfusion at hypothermic and/or normothermic temperature in which an organ-receiving container is arranged in a housing and contains a medium compatible for preserving the organ. A connector detachably mates with the container to alternately enable access to an interior of the container through an opening and seal the opening. A gas source is arranged in the housing and gas therefrom is directed into the container through conduits. Preserving medium is removed from the container and recirculated into the organ such that the preserving medium flow to the organ and the gas flow into the container are separate from one another. Gas is thus absorbed into the medium only in the container. The container is a separate unit from the housing and is separable from the housing. The container can be rendered a self-standing disposable unit which is easily replaced and inclusive of perfusion medium.

Description:
CROSS REFERENCE TO RELATED APPLICATION  
       [0001]     This application claims the benefit of priority from U.S. Provisional Patent Application Ser. No. 60/411,691 filed Sep. 18, 2002, the contents of which are incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates generally to portable apparatus for preserving and transporting organs between donors and recipients while maintaining the organ&#39;s viability.  
         [0003]     The present invention also relates to a perfusion system and method for hypothermic and/or normothermic preservation of organs for transplant purposes.  
         [0004]     The present invention also relates to organ-storage compartments or containers inclusive of perfusion medium for use in organ preservation and perfusion systems and more specifically to containers inclusive of perfusion medium which are designed to receive organs and enable perfusion of the organs with only a single sterile connection between the container and the organ.  
       BACKGROUND OF THE INVENTION  
       [0005]     As improvements in clinical transplantation of human organs such as kidneys advance, there is a growing need for preserving organs from both heart-beating and non-heart-beating donor pools until they can be transplanted. At the same time, the costs for performing a transplant operation are also increasing. Often, part of the cost is caused by the need for a special transportation unit to transport the organ from the donor to the recipient who may be situated a distance away from the donor. Generally, the compartment in which the organ is preserved is built into the transportation unit and thus is not replaceable.  
         [0006]     For preservation, a perfusion medium which can be oxygenated is used such that gas-containing perfusion medium flows into the organ in order to attempt to maintain the viability of the organ.  
         [0007]     Various apparatus exist in the prior art which include a built-in organ-storage compartment and/or provide for an oxygenated perfusion medium to be directed into the organ.  
         [0008]     For example, U.S. Pat. No. 5,362,622 (O&#39;Dell et al.) describes an organ preservation apparatus including a chamber receivable of the organ built into the apparatus. A perfusion medium is directed from an inlet valve through an inlet tube into the organ and removed from outlet valve. Oxygenation of the medium is provided by pumping oxygen into a compartment above a gas permeable membrane which separates the gas compartment from the organ-storage compartment. This, in turns, cause the perfusion medium in the organ-storage compartment to be oxygenated and the membrane to expand the oxygen, thereby causing the oxygenated medium to flow into the inlet valve. Thus, oxygenated medium is directed into the organ.  
         [0009]     U.S. Pat. No. 5,356,771 (O&#39;Dell) discloses another organ preservation apparatus in which the organ is placed in an organ-storage chamber and a pumping chamber is provided alongside the organ-storage chamber. The perfusate in the pumping chamber is oxygenated by pumping oxygen above a gas permeable membrane which allows oxygen into the perfusate in the pumping chamber and also expands causing flow of oxygenated perfusate from the pumping chamber into the tissue chamber. An outlet channel allows flow of perfusate from the tissue chamber to the pumping chamber during off-cycles of the pump. As such, oxygenated perfusate flows into the organ.  
         [0010]     U.S. Pat. No. 5,586,438 (Fahy) shows a portable device for preserving organs by perfusion in which an organ container receives an organ and a circulating system is provided to circulate a perfusion liquid into the organ.  
         [0011]     U.S. Pat. Nos. 5,476,763 and 5,285,657 (Bacchi et al.) shows a medical transport assembly which includes a container for the harvested organ or tissue with a perfusion bag for circulating perfusion liquid through the container. The container includes a body and a lid through which a pipe passes to provide fluid to the organ.  
         [0012]     U.S. Pat. No. 5,326,706 (Yland et al.) shows a homoeostatic organ preservation system which includes a chamber for holding the organ along with a pump for perfusion liquid.  
         [0013]     U.S. Pat. Nos. 3,490,438, 3,717,199, 4,473,637, 5,965,433 and 6,046,046 describe other portable organ preservation apparatus.  
         [0014]     The apparatus described above generally do not provide an organ preservation and transportation apparatus including a low-cost, disposable, replaceable organ-storage compartment which can be discarded after preservation and transportation of an organ whereby a new compartment inclusive of perfusion medium can be used in the apparatus for each additional organ. The present invention addresses this need.  
       OBJECTS AND SUMMARY OF THE INVENTION  
       [0015]     It is therefore an object of the present invention to provide a new and improved portable apparatus and method for preserving organs.  
         [0016]     It is another object of the present invention to provide a new and improved portable apparatus and method for preserving organs which has a low-cost, replaceable organ-storage compartment, optionally, but preferably inclusive of perfusion medium.  
         [0017]     It is yet another object of the present invention to provide a new and improved portable apparatus and method for preserving organs which includes an organ-storage compartment separable from a housing of the apparatus and optionally, but preferably inclusive of a perfusion medium.  
         [0018]     It is still another object of the present invention to provide a new and improved portable, stand-alone apparatus for preserving organs which includes a self-contained power supply.  
         [0019]     It is yet another object of the present invention to provide a new and improved perfusion system and method for hypothermic and/or normothermic preservation of organs for transplant purposes.  
         [0020]     It is another object of the present invention to provide new and improved organ-receiving compartments or containers optionally, but preferably inclusive of a perfusion medium for use in organ preservation and perfusion systems and more specifically to containers inclusive of perfusion medium which are designed to receive organs and enable perfusion of the organs with only a single sterile connection between the container and the organ.  
         [0021]     In order to achieve the above objects, an apparatus for preserving an organ via perfusion at hypothermic and/or normothermic temperature comprises a housing, an organ-receiving container arranged in the housing and optionally, but preferably containing a medium compatible for preserving the organ, a connector detachably mating with the container to alternately enable access to an interior of the container through the opening and seal the opening, a gas source arranged in the housing, an arrangement for directing gas from the gas source into the container; and an arrangement for removing medium from the container and recirculating the medium into the organ. Thus, the preserving medium flow to the organ and the gas flow into the container are separate from one another so that the gas is absorbed into the medium only in the container.  
         [0022]     The container is a separate unit from the housing and is separable from the housing. By providing organ-receiving containers which are separable from the housing and operatively containing a perfusion medium, each container can be discarded after each use and replaced with a new container inclusive of perfusion medium without requiring an entirely new apparatus. This avoids the need to constantly purchase expensive new organ transplant apparatus. The containers can be manufactured at substantially less cost than the cost of manufacturing a new apparatus.  
         [0023]     In a preferred embodiment, the container is made of a flexible material in the form of a bag and can also be referred to as a bio-containment bag. The bio-containment bag is preferably filled with a suitable perfusion medium prior to use and then packaged in a sterile manner.  
         [0024]     The arrangement for directing gas from the gas source into the container may include an external conduit leading from the gas source to a hose barb formed in connection with the container and an internal conduit attached to the hose barb in an interior of the container. A filter can be arranged in connection with the external conduit for filtering the gas from the gas source. Also, a gas bubbler or other type of gas release mechanism may be arranged at an outlet end of the internal conduit.  
         [0025]     The arrangement for removing medium from the container and recirculating the medium into the organ may include a pump, a first hose barb formed in connection with the container, an intake conduit arranged in the container and attached to the first hose barb, a pump conduit connected to the first hose barb and another or second hose barb formed in connection with the container and an organ supply conduit arranged in an interior of the container and attached to the second hose barb. The organ supply conduit is adapted to be attached to the organ. The pump conduit is engaged with a pump to provide for a pumping action of medium through the pump conduit.  
         [0026]     Another embodiment of an apparatus for preserving an organ includes a housing, an organ-receiving container arranged in the housing and containing a medium compatible for preserving the organ, a bung removably connected to the container to seal an opening in the container, a gas source arranged in the housing, an arrangement for directing gas from the gas source through a passage in the bung into the container, and an arrangement for removing medium from the container and recirculating the medium into the organ through another passage in the bung. Thus, the preserving medium flow to the organ and the gas flow into the container are separate from one another so that the gas is absorbed into the medium only in the container.  
         [0027]     To provide for the separate flows of gas and preserving medium, the bung includes two tubes or pipes, each defining one passage and having an upper end outside of the container and a lower end inside the container. In this manner, it is possible to separately regulate the flow of preservation medium to the organ and gas to the container. In prior art constructions wherein the preservation medium is perfused with the gas prior to introduction into the organ-receiving chamber, changes in the perfusion rate are more difficult.  
         [0028]     The container used for organ preservation may be used independent of the apparatus disclosed herein, i.e., in other organ preservation apparatus. In such a case, the container, or bio-containment bag, may comprise a film forming a receptacle having a main opening and three flow openings, a connector part surrounding the main opening, a connector detachably mating with the connector part to alternately enable access to the receptacle and seal the receptacle, three hose barbs each arranged in connection with a respective flow opening, a gas conduit attached in the container to a first hose barb for enabling a flow of gas to be introduced into the receptacle, an organ supply conduit attached in the container to a second hose barb for enabling a flow of presevation or perfusion medium to be directed to an organ when attached to the organ supply conduit, and a medium intake conduit attached in the container to a third hose barb for enabling medium to be drawn from the receptacle for recirculation. A pump conduit extends between the second and third hose barbs outside of the container for engagement with a pump to enable the perfusion medium to be pumped from the medium intake conduit to the organ supply conduit.  
         [0029]     Additional features of such a bio-containment container include a vent formed in connection with the film for venting gas from the receptacle, the weighting of a medium inlet end of the medium intake conduit to ensure that it is below the level of medium in the container and a gas release mechanism arranged at a gas outlet end of the gas conduit.  
         [0030]     As a result of the present invention there are provided portable apparatus for preserving organs which include a low-cost replaceable organ-storage compartment inclusive of perfusion medium to allow the apparatus to be used repeatedly. Other and further advantages will be apparent in view of the following figures and description. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0031]     The invention, together with further objects and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying drawings, wherein like reference numerals identify like elements, and wherein:  
         [0032]      FIG. 1  is a top view of a first embodiment of an apparatus in accordance with the invention with the apparatus shown in an open position.  
         [0033]      FIG. 2  is a perspective view of a first embodiment of a container in accordance with the invention for use in an organ preservation and transportation method and apparatus shown inclusive of perfusion medium.  
         [0034]      FIG. 3  is a side view of the apparatus in accordance with the invention with the apparatus shown in a closed position.  
         [0035]      FIG. 4  is a perspective view of the housing of the apparatus in accordance with the invention shown in  FIG. 1 .  
         [0036]      FIG. 5  is a perspective view of a stabilizer for use with the apparatus in accordance with the invention shown in  FIG. 1 .  
         [0037]      FIG. 6  is a top view of a second embodiment of an apparatus in accordance with the invention with the apparatus shown in an open position.  
         [0038]      FIG. 7  is a schematic diagram of the fluid flow components in the second embodiment of the apparatus in accordance with the invention.  
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0039]     Referring first to  FIGS. 1-5 , the apparatus in accordance with the invention includes a mounting structure or housing  10  having a base  12  and a cover  14 . Hinges  28  pivotally connect the cover  14  to the base  12  and enable the cover  14  to pivot with respect to the base  12  to thereby enable access to an interior of the housing  10 .  
         [0040]     As shown in  FIG. 3 , cooperating locking mechanisms  16  are provided on the base  12  and cover  14  to lock the cover  14  to the base  12  and close the housing  10 , for example, during transport of an organ. It will be understood that alternative means for maintaining the cover on the base are envisioned and will be apparent to those of ordinary skill.  
         [0041]     The base  12  of the housing  10  includes a mounting module or structure  6  to retain the components which enable the preservation of the organ, for example, during transport. As shown in  FIG. 4 , the mounting structure  6  includes compartments  4  receivable of the different components and dimensioned accordingly. The mounting structure  6  is preferably constructed of high-density polystyrene foam in order to provide stability, shock absorbency and, if necessary, thermal insulation. Other materials known to those of ordinary skill which provide stability, shock absorbency and thermal insulation can also be used in the invention. Further, the mounting structure can include several materials or systems whereby each material or system might provide only one of the foregoing functions, e.g., one material or system is used for stability, another for shock absorbency and another for thermal insulation.  
         [0042]     The components which provide for the preservation of the organ includes an organ-receiving compartment or container also referred to as a bio-containment bag  18  which defines an interior which is preferably at least partially filled with a perfusion medium  8  and which retains the organ in the medium when needed for transplate. The medium is one which is capable of maintaining physiological pH and osmotic balance through the preservation/transportation process. An exemplary medium is VIASPAN™, a product of DuPont Merck Pharmaceutical Company. Others will be apparent to those of ordinary skill. See also, for example, U.S. Pat. Nos. 6,235,500, 4,911,929, 4,133,874, 5,049,391, 5,674,528, the contents of each of which are incorporated herein by reference. The apparatus and methods of the present invention are not limited to any specific preservation media.  
         [0043]     The bio-containment bag  18  maybe made of a Class VI approved monoweb film consisting of an inner fluid/organ contact layer made of low-density polyethylene (LDPE), an outer layer comprised of a blend of LDPE and EVA to provide flexibility and durability to the bio-containment bag  18  and an intermediate gas barrier layer made of EVOH to prevent gas exchange between the interior of the bio-containment bag  18  and the atmosphere. An example of bio-containment bag  18  for use in the invention is manufactured by Newport Biosystems, Inc. of Anderson, Calif. and sold under the trademark BIOBAG™.  
         [0044]     The bio-containment bag  18  includes a connector  20  which mates with a cap  22  to seal the bio-containment bag  18  with a sealing gasket  24  being interposed between the cap  22  and connector  20 . The connector  20  may be a screw-type connector with exterior threads whereby the cap  22  includes internal threads. Connector  20  is preferably fixed to the bio-containment bag  18 , and preferably formed integral therewith to avoid leaks of the perfusion medium from the bio-containment bag  18 .  
         [0045]     Bio-containment bag  18  is separable from the base  12  of the housing  10 . As such, it can be discarded after use and replaced with another bio-containment bag  18 . The bio-containment bags  18  are designed to be manufacturable at a relatively low cost, relative to the cost of the entire apparatus and other comparable organ preservation and transportation apparatus.  
         [0046]     Bio-containment bag  18  preferably includes a vent  26  which enables gas to be vented from the interior of the bio-containment bag  18 . Vent  26  may include a suitable membrane filter, i.e. about 0.2 μm or sized as necessary, housed in a plastic module formed integral with the bio-containment bag  18 . In the alternative, the vent  26  may be connected to conduits formed integral with the bio-containment bag  18  by hose clamps or other appropriate attachment mechanism.  
         [0047]     In accordance with the invention, two separate fluid flows are passed into the interior of the bio-containment bag  18 , namely, gas which perfuses the medium in the bio-containment bag  18  and a preservation/stabilization medium which is directed into and around the organ to bathe and/or perfuse the organ. The gas flow, which is preferably a mixture of oxygen and carbon dioxide, originates in a gas cylinder  30  and flows into a conduit  32  external of the bio-containment  18  and which is in flow communication with a conduit  34  inside the bio-containment bag  18 . To allow for the gas flow from conduit  32  to conduit  34 , a hose barb  36  is sealed into the bio-containment bag  18  in connection with conduit  34  and conduit  32  is attached to the hose barb  36  with hose clamps or other suitable attachment mechanism. Conduit  34  leads to a gas bubbler  38  or other type of gas diffusion or release device. The other end of the conduit  32  maybe attached to the gas source using hose clamps or other similar attachment mechanism. Instead of the use of hose barbs, other devices for permitting fluid flow through the film forming the bio-containment bag  18  while enabling attachment of one or more conduits thereto may be used.  
         [0048]     Exemplifying mixtures of oxygen and carbon dioxide for use in the invention range from about 20% to about 95% oxygen with the reminder typically being carbon dioxide. Mixtures of O 2  and CO 2  within this range typically used for in vitro or ex-vivo organ preservation are also contemplated. This mixture will vary, of course, depending on the conditions of organ preservation and organ being preserved. Other gases or gaseous mixtures suitable for in vitro organ preservation could also be used in accordance with the invention.  
         [0049]     A filter  40  is arranged in connection with conduit  32  to filter the gas. The filter  40  is preferably a sterile membrane filter and operates to provide purified gas to the medium in the bio-containment bag  18 . Suitable filters can remove particulates and mesophilic bacteria and fungi, down to about 0.2 μm, or smaller, depending upon the needs of the artisan. In use, gas flows from the gas cylinder  30  through the filter  40  into the conduit  32  and through the hose barb  36  into the conduit  34  to the gas bubbler  38  where it is released and thereby perfuses the medium.  
         [0050]     The other fluid flow is a liquid flow of a perfusion medium. Initially, the bio-containment bag  18  is preferably provided with a quantity of a suitable perfusion medium  100  from a perfusion medium source through an intake conduit  46  attached to a hose barb  42  sealed into the bio-containment bag  18 . The hose barb  42  and conduit  46  are formed with the bio-containment bag  18  to ensure the sterility of the introduction of perfusion medium into the bio-containment bag  18 . Once a sufficient amount of perfusion medium  100  for preservation of an organ is placed into the bio-containment bag  18  through the conduit  46 , the conduit  46  is heat-sealed off, i.e., heat-sealed with the portion  46   a  above the heat seal  44  being removed (represented by the dotted line in  FIG. 2 ).  
         [0051]     During operation, the liquid, i.e. perfusion medium  100 , to be circulated or recirculated is received from a weighted intake conduit  48  connected to a hose barb  50  sealed into the bio-containment bag  18 . Referring now to  FIG. 2  in particular, the end of the intake conduit  48  is weighted so that the conduit  48  extends below the level of medium in the bio-containment bag  18  and thus does not draw gas from the bio-containment bag  18 . One end of another conduit  52  is connected to the hose barb  50  using hose clamps or the like and the other end is connected to another hose barb  58  using hose clamps or the like. Conduit  52  is placed into engagement with a pump  54 . Another conduit  60  is connected to the hose barb  58  and is operatively connected to an artery of the organ  62 , for example, the renal artery when the organ is a kidney. The connection between the conduit  60  and the artery of the organ can be any type of known connector structure for attaching a medical tube to an artery such as a catheter device and surgical clamp device. Optionally, a shunt may be arranged at the end of conduit  60 .  
         [0052]     The pump  54  cycles the perfusion medium continuously through the organ thereby preserving the viability and function of the organ. Pump  54  may be a peristaltic pump so that it does not have any contact with the liquid being pumped through the conduit  52 .  
         [0053]     In one embodiment, a rechargeable (e.g. 12 V) power pack  64  is provided and the pump  54  plugs into the power pack using a suitable adaptor and receives power from the power pack  64 . Power pack  64  can be recharged via a cord connection  56  on the outside of the housing  10  and a spare power pack can be included in the housing  10  for instances when it would not be possible to recharge the power pack prior to exhaustion of the power supply in a single power pack. Also, the cord connection can be used to power the pump  54  when plugged into an external power source.  
         [0054]     The entire bio-containment bag  18  and connections may be wrapped inside a sack  84  to maintain sterility of the components. The sack  84  can aseptically contain the bio-containment bag  18 , the conduits and devices inside it (conduits  34 ,  48 ,  60 , gas release mechanism  38 ), the external conduits and devices (conduits  32 ,  52 , vent  26 , filter  40 ) and the cap  22  and gasket  24 . The sack, in turn, is then placed in the housing  100  stored until  101 .  
         [0055]     As shown in  FIG. 4 , the compartments  4  in the mounting structure  6  are dimensioned for each component. Thus, compartment  4   a  is sized to receive the gas source  30 , compartment  4   b  is sized to receive the power pack  64 , compartment  4   c  is sized to receive a supply of pharmaceuticals, such as antibiotics, for use in the organ preservation procedure, compartment  4   d  is sized to receive the pump  54 , its control unit  54   a , and compartment  4   e  is sized to receive the bio-containment bag  18 .  
         [0056]     As shown in  FIG. 5 , a stabilizer  86  may be used to support the bio-containment bag  18  in the compartment  4   e . The stabilizer  86  has a base  88 , a side wall  90  and an upper wall  92  opposed to the base  88  and having a slot  94 . The slot  94  is designed to slide into engagement with the connector  20  or cap  22  to thereby maintain the bio-containment bag  18  is a stable position during transport.  
         [0057]     To use the apparatus, a transplant facility would obtain the apparatus and a supply of at least one bio-containment bag. The bio-containment bags are sealed and preferably include an acceptable preservation medium. They thus constitute a sterile, filled and closed system without conduits which require cleaning or replacement. Generally, the bio-containment bags will have a shelf life of several months when stored appropriately, e.g., at a temperature of from about 4° C. to about 8° C. Prior to use, each bio-containment bag should be brought to room temperature but may be kept at a temperature of from about 4° C. to about 8° C. depending on the perfusion operation. In alternative aspects of the invention there is provided a kit containing unfilled bio-containment bags which can be filled with the preservation solution desired by the user.  
         [0058]     When a transplant operation of an organ such as a kidney is scheduled, one bio-containment bag inclusive of perfusion medium is removed from cold storage and brought to ambient temperature. Alternatively, if the system employed does not include the perfusate in the bag, it is added to the bag, preferably prior to placement of the organ therein. The apparatus, which may be stored at room temperature, is brought to the sterile surgery suite where the kidney is aseptically removed from the donor and prepared for transplantation into a recipient. This may entail for example, flushing the kidney with a salt solution until all waste product and blood is removed.  
         [0059]     The apparatus is opened to expose its interior and the sack  84 , if present, is unsealed or cut open. The cap  24  is then separated from the bio-containment bag  18  to expose the organ-entry opening. The kidney is attached by the renal artery to conduit  60  which may be done either inside of the bio-containment bag  18  or outside of it by pulling the conduit  60  through the opening. Before placing the kidney into the bio-containment bag  18 , antibiotics may be added. The kidney is then placed into the bio-containment bag  18  and the cap  22  sealed to the connector  20 . Conduit  32  is then connected to the hose barb  36  and/or the gas source  30 . Conduit  52  is inserted into the pump  54 .  
         [0060]     Once all of the connections are made and secured, the pump  54  is turned on to begin the perfusion process. The pump  54  may have a pre-programmed operating cycle controlled by a control unit  54   a . During operating cycles of the pump  54 , perfusion medium is drawn into and through the intake conduit  48 , through opening  48   a  then into and through the conduit  52  and then into and through the conduit  60  into the renal artery of the kidney  62 . The rate of perfusion flow will be governed by the needs of the artisan and the organ being preserved/transported. Suitable flow rates range from about less than 10 ml/min to about 80 ml/min. or greater Other considerations such as outflow from the organ pressure gradient etc. will also be considered for the rate of flow.  
         [0061]     The gas source  30  is also turned on to allow gas flow to the gas release device or bubbler  38 . As such, the gas is perfused into the bio-containment bag  18  where it is absorbed into the medium and transported to the kidney. The cover  14  is then closed and the locking mechanisms  16  engaged. The apparatus is thus ready for transportation.  
         [0062]     If the duration of the transport is greater than the pumping time of the pump  54 , then the pump  54  is recharged using cord connection  56  to a suitable power outlet source or by replacing the power pack with an optionally included auxiliary power pack disposed in housing  10 . Similarly, if the gas source  30  is insufficient for perfusion for the entire duration of the transport of the kidney, then the gas source is replaced as needed.  
         [0063]     Once the apparatus arrives at the site of the recipient, the locking mechanisms  16  are disengaged and the cover  14  opened. The cap  22  is separated from the bio-containment bag  18  and the kidney  62  is then removed from the bio-containment bag  18  and the bio-containment bag  18  discarded. The apparatus is placed into storage and if another bio-containment bag inclusive of perfusion medium is not available for immediate use, then a bio-containment bag is ordered.  
         [0064]     Referring now to  FIGS. 6 and 7 , a second embodiment of an apparatus in accordance with the invention is shown. In this embodiment, the housing  10 , base  12  and cover  14  are used as before but the system included within is modified as described below. The bio-containment bag  64  includes a connector  66  which mates with a bung  68  to seal the bio-containment bag  64 . The connector  66  may be a screw-type connector with exterior threads whereby the bung  68  includes internal threads or other matched mating means. Connector  66  is preferably fixed to the bio-containment bag  64 , and more preferably formed integral therewith to avoid leaks of the perfusion medium from the bio-containment bag  64 .  
         [0065]     Bio-containment bag  64  includes a vent  26  which enables gas to be vented from the interior of the bio-containment bag  64 . A hose barb  70  is also formed in the bio-containment bag  64 , the purpose of which is explained below.  
         [0066]     The bung  68  includes two tubes or pipes  72   a , 72   b  extending from above the bung  68  to below the bung  68  such that when the bung  68  is mated with the bio-containment bag  64 , the pipes  72   a , 72   b  each provide a passage from the exterior of the bio-containment bag  64  to the interior of the bio-containment bag  64 .  
         [0067]     In accordance with the invention, two separate fluid flows are passed into the interior of the bio-containment bag  64 , namely, gas which perfuses the medium in the bio-containment bag  64  and a perfusion medium which is directed into the organ to perfuse the organ. The gas flow, which is preferably a mixture of oxygen and carbon dioxide, originates in a gas cylinder  30  and flows into a conduit  32  leading to one of the pipes  72   a  in the bung  68 . Filter  40  is arranged between the gas cylinder  30  and the bung  68  to filter the gas. Conduit  32  is attached to an upper end of the pipe  72   a  using a hose clamp or other suitable attachment mechanism. To the lower end of the same pipe, a conduit  74  is attached and leads to a gas bubbler  38  or other type of gas release device. Gas thus flows from the gas cylinder  30  through the conduit  32  and filter  40 , through the pipe  72   a  in the bung  68 , through the conduit  74  to the gas bubbler  38  where it is released and thereby perfuses the medium.  
         [0068]     The other fluid flow is a liquid flow of a perfusion medium. The liquid is received from an intake conduit  76  attached to the hose barb  70  sealed into the bio-containment bag  64 . Intake conduit  76  may be weighted so that it is always below the level of medium in the bio-containment bag  64  and thus does not draw in gas from the bio-containment bag  18 . Another conduit  78  leads from hose barb  70  to the pump  54  and a conduit  80  leads from pump  54  to the pipe  72   b  in the bung  68 . Conduit  80  is attached to an upper end of the pipe  72   b  using a hose clamp or the like. Instead of two conduits  78 , 80 , a single conduit can be provided and a pump used with does not contact the fluid, e.g., a peristaltic pump as described above. Another conduit  82  leads from the lower end of the pipe  72   b  to an artery of the organ, the renal artery when the organ is a kidney  62 . The connection between the conduit  88  and the artery of the organ can be any type of known connector structure for attaching a medical tube to an artery such as a catheter device and surgical clamp device.  
         [0069]     For use of this embodiment of the apparatus with a kidney removed from a donor, the apparatus is opened to expose its interior and the bung  68  is separated from the bio-containment bag  64 . The kidney  62  is attached by the renal artery to the lower end of the pipe  72   b  on the underside of the bung  68 . The conduit  74  connected to the gas release device  38  is attached to the lower end of the pipe  72   a  on the underside of the bung  68 . The conduit  74  and gas release device  38  may be present in the bio-containment bag  64  during storage or added thereto once the bung  68  is separated from the bio-containment bag  64 .  
         [0070]     Before placing the kidney into the bio-containment bag  64 , antibiotics may be added. The kidney is then placed into the bio-containment bag  64  and the bung  68  sealed to the connector  66 .  
         [0071]     The conduits  32 ,  78  and  80  are connected, if necessary, between the upper end of the pipe  72   a  and the gas source  30 , between the hose barb  70  on the bio-containment bag  64  and the pump  54  and between the pump  54  and the upper end of pipe  72   b , respectively. Once all of the connections, if necessary, are made and secured, the pump  54  is turned on to begin the perfusion process. During operating cycles of the pump  54 , perfusion medium is drawn into the intake conduit  76 , through the conduit  78  and then into and through the pump  54 . From the pump  54 , the medium is forced through the conduit  80 , through the pipe  72   b , through the conduit  82  into the renal artery of the kidney.  
         [0072]     The gas source  30  is also turned on to a pre-determined indicator to allow gas flow to the gas release device  38 . As such, the gas is perfused into the bio-containment bag  64  where it is absorbed into the medium and transported to the kidney. The cover  14  is then closed and the locking mechanism  16  engaged. The apparatus is thus ready for transportation.  
         [0073]     Once the apparatus arrives at the site of the recipient, the locking mechanism  16  is disengaged and the cover  14  opened. The connection to the bung  68  are removed and the bung is then separated from the bio-containment bag  64 . The kidney is removed from the bio-containment bag  64  and the bio-containment bag  64  is then discarded. The conduits  32 , 78  and  80 , if reusable, are cleaned and prepared for the next use. The apparatus is placed into storage and if another bio-containment bag is not available for immediate use, then a bio-containment bag is ordered.  
         [0074]     Thus, as disclosed above, an organ preservation and transportation apparatus is shown including a disposable and replaceable organ-storage compartment inclusive of perfusion medium. Low-cost organ preservation and transportation is provided because after the initial purchase of the apparatus, the only component which needs to be replaced for each organ is the bio-containment bag  64 . The cost of the bio-containment bag inclusive of perfusion medium is quite small relative to the cost of the apparatus.  
         [0075]     Throughout the description, mention is made of a kidney as the organ being preserved/transported. It is to be understood that the apparatus and methods described herein can be used with any organ, e.g. heart, liver, etc. or portion thereof. In certain aspects of the invention where no organ artery is available for connection to conduit  60 , the transported organ is placed in fluid communication with the conduit end so that the organ is bathed with the perfusate.  
         [0076]     While particular embodiments of the invention have been shown and described, it will be obvious to those skilled in the art that changes and modifications may be made without departing from the invention in its broader aspects, and, therefore, the aim in the appended claims is to cover all such changes and modifications as fall within the true spirit and scope of the invention.