Abstract:
A cold storage and transportation device is provided which features a cooler having a metal housing and having an internal cavity adapted for placement of a storage rack therein. The storage rack is configured with a plurality of formed sections adapted to hold biological products, such as blood, in flexible bags safely and at a controlled temperature. Circular winding of the refrigeration tubing enhances cooling and temperature maintenance.

Description:
FIELD OF THE INVENTION 
       [0001]    This application claims priority to U.S. Provisional Patent Application Ser. No. 62/086,099 filed on Dec. 1, 2014, and incorporated herein in its entirety by this reference thereto. 
         [0002]    The present device relates to the storage for transport of refrigerated items. More particularly the disclosed device, relates to a rack device configured to hold a plurality of flexible bag containers, or other such containers, in optimal positioning for support during transport. The rack is configured to provide optimal circulation of airflow from a surrounding mating cooler and communicate such to the bags held in the rack, to maintain them in a chilled condition. The device is particularly well configured to transport blood, plasma, and other biological material which must be maintained chilled. 
       BACKGROUND OF THE INVENTION 
       [0003]    Since it was discovered that blood and other blood and biological products could be provided from donors for patient treatment, the transport of blood and blood products and other biological materials has been a particular problem. This is because should such products fail to be strictly maintained at particular low temperatures at all times, spoilage can result. In fact, temperature-compromised blood and blood products, tissues, cells, donor organs, and other biological materials are of particular concern to medical professional. This is because should these products become temperature-compromised during storage or transport to a recipient, infection, rejection, and even death to such a receiving patient can occur. 
         [0004]    A strict requirement of the FDA provides that if blood or blood products are removed from cold storage at a facility, and transported to another location, the blood products so transported must be maintained during transport within a temperature range of 1° C. to 10° C. Other blood products such as red blood cells must be kept at a monitored temperature range of 1° C. to 6° C. during transport. This is also a requirement to meet the FDA standards. 
         [0005]    Still further, other biological products, and medicines and vaccines for example, have similar FDA and other requirements for transport. Such must be maintained at all times at a constant temperature which is constantly below and above particular threshold levels. Such threshold levels are well below room-temperature and any elevated temperature during such transport above or below these threshold levels, can easily cause spoilage and health risks to patients. 
         [0006]    Conventionally, the transportation of such biological products by the health care industry, has required the employment of insulated containers such as coolers. While similar to ice chests employed to hold cold beverages, these medical coolers have been developed and manufactured in a similar fashion to those used for the recreational industry. Adaptations for medical carriers include internal cavities where blood, blood products, biologicals and medicines are positioned during transport to help maintain their temperature between threshold levels, and to keep the products orderly. 
         [0007]    However, such coolers are as noted, generally designed for drinks and recreation. Consequently, conventional medical coolers do not provide for internal air flow and product spacing which maximizes communication of chilled air to the stored items. Further conventional medical containers lack a configuration to concurrently preventing cooler-burn from affecting blood products and the like. Cooler-burn generally occurs from overly cold temperatures contacting portions of stored bags and the like used for blood and blood products for too long of a duration. Further, conventional coolers do not provide a rack or removable containment component, which holds the bags or containers in an organized inventory, and which are configured with apertures and transparent walls which allow easy identification of the held bags or containers without removing them from the rack itself. 
         [0008]    Finally, conventional coolers even where refrigerated, generally require corded access to electric power during transport to maintain internal refrigeration. Further, such refrigerated coolers are inefficient in design and construction. 
         [0009]    As such there exists an unmet need, for a transport system which provides a housing configured to maintain internal temperatures within an internal cavity, at temperature levels between low and high thresholds required to prevent spoilage of blood, blood products, biological products and tissue, and medicines. Such a system should employ a refrigeration system with onboard rechargeable electric power for running an onboard refrigeration system. Such a system should ideally provide a container housing which is configured to generate refrigerated air within the internal cavity. Such a system in addition to providing a housing having an internal cavity with proper temperature ranges, should also provide for the orderly and protected transport of bags and the like therein, such that they receive constant chilling from excellent internal airflow. Further, so positioned, such a system should allow for the removal and easy replacement of the stored bags or containers for blood and blood products, in an orderly fashion in a manner which protects the flexible bags and holders for blood and blood products from puncture or damage, but still provides a positioning thereof which maximizes airflow around exposed surfaces to maintain temperature and prevent burning or spoilage of portions of the held products in small areas which might get too cold in conventional housings. Finally, such a system should provide for a rack or container which allows the user to easily read and identify the labeling of the contents or any stored bag or container, so that when removed in the rack the user need not have to remove the containers from the rack itself to identify the contents. 
         [0010]    The forgoing examples of related art and limitation related therewith are intended to be illustrative and not exclusive, and they do not imply any limitations on the invention described and claimed herein. Various limitations of the related art will become apparent to those skilled in the art upon a reading and understanding of the specification below and the accompanying drawings. 
       OBJECTS OF THE INVENTION 
       [0011]    It is an object of the present invention to provide a system for transport of blood, blood products, and biological products, in a manner that maintains housed products within a predetermined temperature range. 
         [0012]    It is an additional object of this invention to provide such a system which provides a means to easily insert and remove the products being transported from the internal cavity of a cooler housing, while protecting them from puncture and abrasion, and concurrently positioning them for optimal airflow there around once positioned in the housing. 
         [0013]    Further, it is an object of this invention to provide such a cold transport system, which provides a rack that is complimentary in shape to an internal cavity of a transport cooler housing, which holds, protects, and allows easy identification of the held containers or bags therein, without their removal from the rack itself. 
         [0014]    Still further it is an object of this invention to maximize the efficiency of the portable cooler through the employment of a 360-degree winding of the refrigerant cooling system which maximizes heat transfer as well as providing a unified maintenance of cool temperatures within an inner cavity. 
         [0015]    These and other objects, features, and advantages of the present invention, as well as the advantages thereof over existing prior art, which will become apparent from the description to follow, are accomplished by the improvements described in this specification and hereinafter described in the following detailed description which fully discloses the invention, but should not be considered as placing limitations thereon. 
       SUMMARY OF THE INVENTION 
       [0016]    In accordance with the purposes of the present invention, as embodied and broadly described herein, the present invention provides a device and system configured for the orderly transport of blood, blood products, biological products, medicines, and other products employed in the medical field, which are required to be maintained between low and high temperature thresholds at all time, to avoid spoilage. 
         [0017]    The system features a cooler having a housing with an internal cavity defined by a refrigerated sidewall surface adapted to maintain the temperature within the internal cavity, at a refrigerated temperature relative to surrounding air and in a range between a high and low temperature. The housing preferably has an onboard refrigeration unit which is battery powered and adapted to maintain the internal cavity between the desired temperature thresholds for an anticipated duration for travel of the contents positioned within the internal cavity. 
         [0018]    Heat transfer of the regeneration system is maximized by the 360-degree winding and contact of a coolant conduit with the metal walls of the cooler housing defining the exterior surface. The cooling of the internal cavity also employs a 360-degree wrapping of refrigerant conduits in contact with the sidewall defining the sides of the internal cavity. This configuration maximizes the heat transfer and provides an even communication of such to the surrounding sidewall for heat transfer thereby eliminating warm and cold spots within the internal cavity. 
         [0019]    The internal cavity is preferably dimensioned to a configuration which is complimentary to a perimeter shape of a caddy or rack which is positionable within the internal cavity in an as-used position. A base on the rack defines the perimeter and is bordered by opposing sides and endwalls. The rack is removable and re-insertable into the internal cavity as needed and has a plurality of sections formed on the rack adapted to accommodate the insertion and carrying of bags and other containers used for blood or other blood products, or biological products therein during use. With the bag containers so positioned, the rack is removable and repositionable from and to the internal cavity, while concurrently protecting the flexible bag containers positioned within individual walled sections of the rack. 
         [0020]    Especially preferred is the formation of the rack itself, from transparent material. By forming all portions of the rack or caddy from transparent material, it allows the user to easily view and read and identify the contents of any container, whether it be positioned in a section adjacent the perimeter of the rack, or at an inner position of the rack. 
         [0021]    Also especially preferred is that the sections defined in the rack to hold containers, have a wall surrounding them having a plurality of apertures located there around because such a configuration protects the containers, some of which are easily punctured or damaged, from contact or communication with sharp or abrasive surfaces during use, while allowing for maximized airflow to maintain temperatures. 
         [0022]    Additionally preferred is the formation of the basket or rack or caddy, with a perimeter, which is defined by the shape of a base, which is complimentary to that of the internal cavity of the temperature controlled housing in which it occupies an as-used position during use. This allows all portions of the rack or caddy to be properly insulated. It is especially preferred that the corders of the rack be angled and have openings formed at each. These openings communicate with and end passage which is in communication with respective ends of the rack to further enhance airflow to and from the products held in the rack. 
         [0023]    Further, it is preferred that internal walls forming the sections of the caddy, and perimeter walls thereof, are adapted with apertures which allow for maximized airflow through the rack or caddy and around the surfaces of the containers or bags positioned in the individually formed section. Currently, apertures which align in two directions are particularly preferred. 
         [0024]    These apertures by allowing maximized airflow as noted, maintain a more uniform temperature of the contents of the containers. Further, cold or hot spots which occur with conventional transport devices are effectively prevented by this constant and maximized airflow, thereby protecting the contents of the containers from small but potentially dangerous areas of spoilage during transport from becoming too cold, or too warm in those areas. 
         [0025]    Finally, it is preferable that a handle be provided formed into the transparent polymeric material forming the rack or caddy at an upper edge. This allows the user to easily remove and replace the rack or caddy into the internal cavity of a transport insulated housing. By forming the central wall providing the area for an aperture defining the handle, as well as all side and internal walls of transparent polymeric material, the easy identification of bags or containers positioned in any formed section is facilitated such that the user need not remove the container from the rack or caddy to identify its contents. 
         [0026]    With respect to the above description, before explaining at least one preferred embodiment of the herein disclosed temperature controlled transport device and method invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangement of the components in the following description or illustrated in the drawings. The device herein described and disclosed in the various modes and combinations is also capable of other embodiments and of being practiced and carried out in various ways which will be obvious to those skilled in the art. Any such alternative configuration as would occur to those skilled in the art is considered within the scope of this patent. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting. 
         [0027]    As such, those skilled in the art will appreciate that the conception upon which this disclosure is based may readily be utilized as a basis for designing of other temperature controlled transport devices for blood and biological materials, for carrying out the several purposes of the present disclosed device. It is important, therefore, that the claims be regarded as including such equivalent construction and methodology insofar as they do not depart from the spirit and scope of the present invention. 
     
    
     
       BRIEF DESCRIPTION OF DRAWING FIGURES 
         [0028]    The accompanying drawings, which are incorporated herein and form a part of the specification, illustrate some, but not the only nor exclusive examples of embodiments and/or features of the disclosed device. It is intended that the embodiments and figures disclosed herein are to be considered illustrative of the invention herein, rather than limiting in any fashion. In the drawings: 
           [0029]      FIG. 1  depicts an isometric view of the rack of the device herein showing the transparent rack having a perimeter complimentary to the perimeter of a sidewall defining an internal cavity of the insulated transport housing shown in  FIG. 2 , and showing the transparent walls allowing identification of held products. 
           [0030]      FIG. 2  depicts the rack of  FIG. 1 , being inserted into the internal cavity defined by an internal sidewall of the portable cooler. 
           [0031]      FIG. 3  shows an end view of the carrying rack showing aligning apertures formed in the walls defining sections to maximize airflow therethrough, and the transparent material forming the rack. 
           [0032]      FIG. 4  depicts a side view of the transparent rack formed of polymeric material and the plurality of apertures communicating through a central wall which align with similar apertures in opposing sides and showing the container-holding sections formed on each side. 
           [0033]      FIG. 5  shows an overhead view of the rack of  FIGS. 1-4  and showing the perimeter shape of the rack with preferred angled corners and a shape being complimentary to the perimeter of the sidewall defining the internal cavity as in  FIGS. 2 and 6 . 
           [0034]      FIG. 6  shows a graphic depiction of a preferred configuration of the refrigerant conduits completely around an exterior wall and the internal sidewall forming the cavity. 
           [0035]      FIG. 7  is a graphic depiction showing the coolant flow through conduits which run in a circular pattern around the exterior wall of the cooler and sidewall of the internal cavity thereby maximizing cooling and minimizing hot and cold spots in the cavity. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0036]    Now referring to drawings in  FIGS. 1-7 , wherein similar components are identified by like reference numerals, there is seen in  FIGS. 1 and 2 , the device  10  which features a rack  20  which is adapted for operative engagement within an internal cavity  18  of a housing  12  having and exterior wall  14  and a lid  16 . A sidewall  15  extending between a base or bottom surface of the internal cavity  18  and a top of the housing  12  define the sealable internal cavity  18 . 
         [0037]    As can be seen, the internal cavity  18  is dimensioned in a perimeter shape that is complimentary to the perimeter of a caddy or rack  20 , which is positionable within the cavity  18  in an as-used position during transport of containers held in the rack  20 . The perimeter of the rack  20  is determined by the shape of a base  13  from which opposing sidewalls  27  and endwalls  25  rise and which surround a plurality of formed sections  24  acting as holders or containers for products inserted therein. 
         [0038]    Preferably the perimeter of the cavity  14  is only slightly larger than the perimeter of the rack  20  so as to maintain the sidewall  15  adjacent to the sides of the rack  20  and minimize space therebetween. For example, the sidewall  15  should be between 0.25 inches and 1.5 inches away from the perimeter edge of the rack  20 . 
         [0039]    As also noted, it is preferable that the corners  12  of the rack  20 , where the side and ends intersect, are angled, and a gap  23  is positioned between the endwall  25  and sidewall  27  of the rack  20 . This gap  23  allows for air within the passage  29  communicating through the corners  21  above the base  13  of the rack  20 , to more easily come into contact with the sidewall  15  of the internal cavity  18 . This action has been found to enhance cooling and temperature control provided by the coiled refrigeration tubing formed in windings around the sidewall  15 , by providing a direct pathway for air communication through the passage  20  as well as through apertures  32  located on opposing sides of the formed sections  24 . 
         [0040]    As can also be discerned from the drawing in  FIG. 1 , the rack  20  is formed of substantially transparent polymeric material. This allows the user to view into the individual formed sections  24  through the material forming the rack  20 . Such is particularly preferred because when viewed the formed sections are viewed from the side or overhead by a user, the individual containers  22  positioned within formed section  24  of the rack  20  can be seen, as can indicia thereon. This allows the user to identify the containers  22  for contents or type by viewing them or indicia thereon, without removing them from the rack  20 . 
         [0041]    Also shown in  FIG. 2 , is a handle  26  formed at a central location of a central wall  28  of the structure forming the rack  20 . The handle  26  is defined by a handle aperture  30 . communicating through the transparent central wall  28 . Sections  24  can also be seen through transparent walls and central wall  28 . 
         [0042]    In  FIG. 3  can be seen an end view of the rack  20  where sections  24  which are formed by individual transparent polymeric surfaces. In the view of  FIG. 3 , apertures  32  can be seen through the transparent end wall  25  of the rack  20 . As noted these apertures are formed to maximize airflow through the rack  20  and the individual formed sections  24  which hold the containers therein, when the rack  20  is within the cavity  18 . The passage  29  in-between the endwall  25  and the first section  24  communicates with the apertures  32  within the passage  29 . The apertures  32  preferably communicate through the wall surfaces on opposing sides of each section  24  and are aligned through all the sections  24  thereby allowing better communication with the passage  29 . 
         [0043]    Shown in  FIG. 4 , is a side view of the rack  20  showing the transparent sidewall  27  and formed sections  24  on one side of the central wall  28 . The central wall has apertures  32  formed therein which communicate with the sections  24  on either side. Apertures  32  formed in the sidewall  27  communicating with each section  24 , are preferably aligned with the apertures  32  formed through the center wall  28 . This aligns apertures  32  on all opposing sides of each section  24 , with adjacent apertures  32  also as noted aligned to maximize airflow through the individual sections  24  which hold individual containers  22 . 
         [0044]    In  FIG. 5  is seen an overhead view of the rack  20  shown in  FIGS. 3-4 . The formed sections  24  can be seen on both sides of the central wall  28  and in-between sidewalls  27 . The passage  29  communicating between each corner  24  on the ends of the rack  20  may also be used for holding cold packs or other chilling components therein should the rack  20  be paired with a container which does not have onboard refrigeration, or should refrigeration cease. 
         [0045]    Shown in  FIGS. 6 and 7 , the device  10  is configured with a unique refrigeration system which maximizes the contact of the refrigerant-carrying refrigeration conduit  37  or tubing, in a circular condenser circuit  39  running in a circular path around the entire surface of the metal exterior wall  14  of the cooler housing  12 . The system includes a compressor  36  in operative electric engagement with a rechargeable battery  38  or a battery charger connected to the battery  38 , or other source of electric power of sufficient voltage and amperage to power the compressor  36 . The compressor  36  operates to move Freon or other refrigerant gas through the condenser circuit  39  and an evaporator circuit  34  which includes a dryer  33  and capillary tube  35  connecting the two circuits. A fan  41  can also be included to cool the compartment housing the compressor  36 . 
         [0046]    Particularly preferred are the circular pathways forming both the condenser circuit  39  and the evaporator circuit  34  which was found through experimentation to maximize performance of the refrigeration of the device  10 , over other designs which only employed two or three surfaces of the sidewall  15  and the exterior wall  14 . 
         [0047]    By forming multiple circular windings of the conduit  37  in thermal contact with the aluminum or other metallic exterior wall  14 , the area for communicating heat from the internal cavity  18  to the exterior wall  14  is maximized, and the curves in the conduit  37  impeding flow minimized over other configurations. Thus, all four sides of the exterior wall  14  are employed to dissipate heat. 
         [0048]    The conduit  37  in the condenser circuit  39  is placed in a thermally conductive engagement against an inside surface of the exterior wall  14  and run for 4 to 8 revolutions in this thermal contact against the exterior wall  14 . Thermal conduction is enhanced by chalking the conduit  37  with graphite thermal paste (not shown), and then covering it to hold it against the exterior wall  14  with aluminum tape (not shown). 
         [0049]    The evaporator circuit  34 , is also enhanced by the circular configuration of the tubing  37  against all sides of the aluminum or other metallic sidewall  15  forming the sides of the interior cavity  18 . The evaporator circuit  34  forming the cold or heat-absorbing side of the refrigeration cycle, is insulated all around the sidewall  15  and bottom of the internal cavity  18  in-between the external wall  14 , with an insulation, (not shown). A currently preferred insulation is polyurethane foam which may be formed by injection or otherwise positioned in-between the internal cavity  18  and the exterior wall  14 . 
         [0050]    The internal cavity  18  is formed from metal wherein the sidewall  15  at least is formed from metal such as aluminum, copper, stainless steel or other metal which will communicate heat from the internal cavity  18  to the evaporator circuit  34  winding in a circular fashion around the sidewall  15 . 
         [0051]    In thermal contact with the sidewall  15 , the evaporator circuit  34  is wound from a seamless metal refrigeration conduit  37  such as one formed from copper, which would also be preferred in the condenser circuit  31 . Although, aluminum might also be employed for the conduit  37 . 
         [0052]    The diameter of the conduit  37  forming the evaporation circuit  34  is small then the diameter of the conduit  37  forming the condenser circuit  39 . Currently, a diameter of 3/16″ for the condenser circuit  39  and a diameter of ¼″ for the evaporation circuit  34  is preferred, but such may change with varying sizes of the device  10 . The conduit  37  forming the evaporator circuit  34  is also caulked with graphite thermal paste (not shown) and held in thermal contact with all four sides of the sidewall  15  forming the internal cavity  18  by aluminum tape. Other modes for thermal enhancement and engagement of the conduit of either the condenser circuit  39  or evaporator circuit  34  can be employed. 
         [0053]    This circular winding path of the evaporation circuit  34  has also been found to significantly enhance cooling of the internal cavity  18  using a continuous conduit  37  in a winding in a circular path around the exterior surface of the sidewall  15  opposite the side of the sidewall  15  defining the internal cavity  18 . A winding from four to eight revolutions around the exterior of the sidewall  15  by the conduit  37  forming the evaporation circuit  34  has shown to work well. Again, by using a plurality of windings of the conduit  37  making four to eight revolutions around the sidewall  15  surfaces forming the internal cavity  18 , the number or sharp bends is eliminated and the flow of refrigerant enhanced as well as maximizing the thermal contact of the conduit  37  with all sections of the sidewall  15  on all sides of the internal cavity  18 . 
         [0054]    It should be noted that the significant improvement in cooling provided by the configuration of the housing  12  of the cooler and refrigeration circuits will work with any rack  20  of other configurations. Thus, other racks  20  of other configurations can be employed with the housing  12  herein and benefit from the improved cooling system. However, the rack  20  herein with its formation of apertures  32  and sections  24  and transparent material and flow paths through the aligned apertures  32  has shown to enhance the cooling provided when engaged within the housing  12  and would be preferred. 
         [0055]    As noted, any of the different configurations and components noted herein for the device  10  can be employed with any other configuration or component shown and described herein. Additionally, while the present invention has been described herein with reference to particular embodiments thereof and steps in the method of production, a latitude of modifications, various changes and substitutions are intended in the foregoing disclosures, it will be appreciated that in some instance some features, or configurations, or steps in formation of the invention could be employed without a corresponding use of other features without departing from the scope of the invention as set forth in the following claims. All such changes, alternations and modifications as would occur to those skilled in the art are considered to be within the scope of this invention as broadly defined in the appended claims.