Abstract:
The invention is directed to a reusable container for transporting blood and blood products providing the ability to not only transport, but also to monitor and maintain refrigerated blood or blood products at optimal temperature range for more than twenty-four (24) hours without the use of wet or dry ice, or gel packs.

Description:
PRIORITY CLAIM  
       [0001]     The present application is a regular Non-Provisional Patent Application claiming priority to U.S. Provisional Patent Application, Container for Transporting Blood and Blood Products, Ser. No. 60/681,769 filed May 17, 2005 and the entire disclosure of the Provisional Application Ser. No. 60/681,769 is incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The invention relates to an improved container for transporting blood and blood products at the required temperature range for extended periods of time without the use of either wet or dry ice, or gel packs, in a durable, reusable container that is capable of maintaining and monitoring the temperature in transit for compliance with certain protocols.  
       BACKGROUND OF THE INVENTION  
       [0003]     Transporting blood and blood products in a timely manner has always been a problem. Generally, the health care industry has relied on products developed and manufactured for the recreational industry for keeping food and beverages cold as a working solution. However, the recreational industry did not, and could not address the need for documented temperature monitoring for blood products for transfusions that the Food and Drug Administration (FDA) now requires as of 2004. Thus, the healthcare industry is in desperate need for a better solution to transport blood, blood products, human tissues, stem cells, and donor organs, which require documented temperature tracking for FDA compliance.  
         [0004]     Spoilage and the risk of infection from stale blood, blood products, tissues, cells or donor organs are also of paramount concern. The FDA requires that blood and blood products being transported must be maintained at a certain temperature range. For instance, packed red blood cells should be maintained at a temperature range of 1° C. to 6° C.; fresh plasma thawed (for use) requires a temperature range of 1° C. to 6° C.; platelet concentrates must be maintained at 20° C. to 24° C.; and fresh frozen plasma must be stored at or below −25° C.  
         [0005]     Additionally, transporting blood and blood products require that certain protocols be met in order to prevent exposure, damage or contamination while in transit. Many blood banks try to solve this problem by transporting blood and blood products in a leak proof primary container placed in a secondary container, such that the specimen is protected from inadvertent puncture or contamination. The units of red blood cells are then packed on wet or dry ice or a chemical coolant to be transported in Styrofoam® containers.  
         [0006]     However, one of the limitations of this method of transportation is that wet ice is messy, often spills during transportation, and re-icing while in transit is sometimes challenging in remote areas. Dry ice offers its own complications as it can be hazardous where if for example loose dry ice inadvertently touches the blood or blood product, it may freeze the blood or blood product at the area of contact and damage the entire unit. Additionally, dry ice is sometime unavailable in certain parts of the world. These factors only serve to further limit the ability to transport blood and blood products for prolonged periods. To alleviate this problem, frozen gel packs have been used to help maintain required temperatures. However, gel packs are susceptible to leaks and are therefore unreliable.  
         [0007]     Another disadvantage is that the blood and blood products have limited viability over prolonged periods even if transported at the required temperature range. Red blood cells when stored at the required temperature range are viable for up to six (6) hours, while blood platelets are limited to four hours expiration time. Conventional insulated shipping containers do not address this problem, which can be further complicated when blood or blood products are being transported internationally. Thus, there still exists a need to be able to transport blood and blood products efficiently and safely for periods lasting longer than four to six hours without the use of either wet or dry ice, or gel packs in a durable, reusable container that is capable of maintaining or monitoring the temperature in transit for compliance with certain protocols.  
       SUMMARY OF THE INVENTION  
       [0008]     The invention is directed to a reusable container for transporting blood and blood products providing the ability to not only transport, but also to monitor and maintain the refrigerated blood or blood products at the necessary temperature range for more than twenty-four (24) hours without the use of wet or dry ice, or gel packs. The container is capable of transporting 1 to 2, 1 to 4, or 1-6 or more units of blood from the blood bank to Operating Room, Emergency Room, dialysis, cancer center, home health care facilities or any other facility where blood is used.  
         [0009]     The container comprises of a waterproof outer case, which may be constructed from hard, durable, rustproof material or a soft, flexible, lightweight material that is durable and stain resistant. The outer case provides for varied means for lifting and towing the container, which may be singularly employed or in combination thereof, for example a reinforced handle on the top of the container, wheels, a telescopic handle, non-retractable handles and shoulder straps.  
         [0010]     The exterior of the container contains at least one information sleeve adapted to hold identification information concerning the blood or blood product being transported. A patient&#39;s name, social security or identification number, surgeon, blood type, date the blood or blood product left the blood bank, scheduled date of delivery, number of units of blood, delivery operating room number, surgeon, doctor and medical procedure can be documented and stored in the information sleeve.  
         [0011]     The container further comprises of an insulated layer having four side walls, a bottom portion, and an open top defining a receptacle area for receiving the insulation deck. The walls and the bottom portion of the insulated layer have a predetermined thickness to thermally insulate the container. The insulated layer substantially surrounds the inner perimeter of the outer case. The container also includes an insulation deck that provides for a bottom portion being connected to walls substantially surrounding the insulation layer forming a seamless well for spill proofing and for receiving the cooling elements. The insulation deck is secured to the outer case by appropriate securing means forming a receptacle area for receiving the cooling elements.  
         [0012]     The cooling elements are an important feature of the container in accordance with the present invention. The cooling elements comprise of four modular units shaped and sized to securely fit the top, bottom and sides of the inner perimeter of the insulation deck and is adapted to form a receptacle area for housing an inner caddy. The cooling elements are responsible for keeping the inner caddy at the required temperature (1° C. to 6° C.), and is made from strong, durable and lightweight material. A refrigerant material is disposed in all or part of the cooling elements and may include a phase change gel. The cooling elements are adapted to, when frozen and conditioned, maintain the required temperature for extended periods of time, i.e. 24+ hours. The cooling elements must be frozen prior to each day&#39;s use in any standard or commercial freezer for up to 24 hours prior to each use. The cooling elements are stackable and provides for easy storage in a freezer. After removal from the freezer, the cooling elements must be conditioned prior to use and insertion into the container. The object of conditioning the cooling elements is to allow it to transition from the temperature of the freezer to a temperature proximal to the desired phase change temperature. This is achieved simply by exposing the cooling elements to the ambient room temperature by placing it out on a counter (not in the insulated case), for approximately 30 to 60 minutes.  
         [0013]     The container includes an inner caddy, which provides for a bottom portion connected to sidewalls, a front wall, a back wall and a middle divider. Lifting means are provided from lifting and removing the inner caddy from the container. Lifting means may include a handle, strap, tab, or anything that can be grasped or is generally known and used by those skilled in the arts. In one embodiment, the walls include one or more top portions that are hingedly connected to a lid extending outwardly open from the receptacle area to form gull wings. In another embodiment, the inner caddy opens from front to back providing access to its contents. The inner caddy is removable with cleaning vents, allowing for self-drainage and ease of cleaning. The inner caddy is conveniently sized such that it may be stored in a standard or commercial refrigerator until the blood or blood product is ready for use.  
         [0014]     The container is further equipped with a receiving area for a temperature data-logging device which comprises of at least one probe for monitoring, collecting and reporting data concerning the blood or blood units being transported. Suitable temperature data-logging devices may include for example a Validator, which consists of proprietary technology currently available through American Thermal Wizard International, Inc. The temperature data-logging device is programmable to meet the compliance requirements and will continuously monitor the temperature of the blood or blood products while it is housed in the container. The information once logged can be graphed or logged and is capable of being downloaded into Microsoft Word® or Excel®. The temperature data-logging device can be programmed to either transmit an alarm or a page if the temperature range falls or exceeds the set parameters.  
         [0015]     For a further and more fully detailed understanding of the present invention, various objects and advantages thereof, reference is made to the following detailed description and the accompanying drawings. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0016]     Further objectives and advantages of the invention will become more apparent from the following description and claims and from the accompanying drawings herein.  
         [0017]      FIG. 1  depicts a container for transporting blood and blood products.  
         [0018]      FIG. 2  depicts an external view of one embodiment of the container for transporting blood and blood products.  
         [0019]      FIG. 3  depicts an alternate embodiment of the container for transporting blood and blood products.  
         [0020]      FIG. 4  depicts an embodiment of the cooling elements of the invention.  
         [0021]      FIG. 5  depicts one embodiment of the inner caddy. 
     
    
     DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0022]     By reference to the exemplary drawings in detail wherein like numerals indicate like elements throughout the various views, there is shown in  FIG. 1  the container  10  for transporting blood and blood products in accordance with the invention.  
         [0023]     The container  10  comprises of an outer case  11  that may be formed from soft, flexible, lightweight material like canvas, or hard rigid material for more durability, or any other suitable materials generally known and used by persons skilled in the art. In both embodiments, the outer case  11  is made of waterproof, stain resistant, rustproof material, is easily cleaned, and reusable. The container  10  may be made in different sizes depending on the number of blood or blood units that are being transported. In one embodiment, the container  10  holds 1-2 units of blood or blood products. In another embodiment, the container  10  holds 1-4 units of blood. Alternatively, the container  10  holds either 1-6, or more units of blood or blood products.  
         [0024]     The outer case  11  comprises of a base  12  which may be formed from a reinforced or stiff material, or of other suitable materials generally known and used by persons skilled in the art. In an alternate embodiment, the base  12  may include a rigid base insert covered with a flexible material. The outer case  11  further comprises of ends  14  and  14 ′ (not shown) that are connected to the base  12 , with sides  15  and  15 ′ (not shown) extending between the ends  14  and  14 ′ (not shown).  
         [0025]     The container  10  provides for a lid  17 , which is hingedly attached to the sides  15  and  15 ′ (not shown) of the outer case  11  and is closeable by twist latches  30 ,  30 ′. Preferably, at least one twist latch  30  is lockable. Alternatively, other suitable forms of closeable means such as hooks, loops, snap fasteners, buttons, Velcro or zippers may be employed to close the lid  17 .  
         [0026]      FIG. 3  depicts one embodiment of the invention wherein the lid  17  may be removable from the container  10  and is hingedly attached to one of the sides  15 , and may be closable with at least one zipper  29  and  29 ′. Alternatively, the zipper  29  may extend around the entire periphery of the lid  17  such that the lid  17  is completely removable. In another embodiment of the invention, the lid  17  may have a zipper  29  extending around two ends  14 ,  14 ′ and one (1) side  15  so that the lid  17  may be hinged at its attached side  15  providing maximum opening without being completely removable. However, it will be appreciated by those skilled in the arts of the invention that any form of a lid  17  may be employed.  
         [0027]     In one embodiment, the lid&#39;s interior  13  comprises of closed cell PE foam insert that acts as a water barrier to protect the interior contents of the container  10 . In another embodiment, insulation is added to the lid&#39;s interior  13  to prevent the transmittal of external heat thus protecting the interior contents of the container  10 . In an alternate embodiment, a cooling module is added to the lid&#39;s interior  13  wherein refrigerant material is disposed within further enhancing the performance of the container  11 .  
         [0028]     As shown in  FIG. 2 , a wheel assembly  16 ,  16 ′ and anchor screws  18 ,  18 ′,  18 ″ located on one of the opposing ends  14  provides stabilizing means for the container  10  when stood on its end  14 . The stabilizing means allow the container  10  to be placed flat on its base  12  without the container  10  tipping over. Other stabilizing means may include at least a foot, claw or any other stabilizing means that is generally known and used by persons skilled in the art. In one embodiment of the invention, a telescopic handle  19  may be provided adjacent to the base  12  for pulling the container  10  on the wheel assembly  16 ,  16 ′. The telescopic handle  19  is capable of gradually extending to the desired height from the top end  14 ′ of the container  10  when a push button  20  is pressed. The push button  20  also serves to retract the telescopic handle  19  when pressed.  
         [0029]     The container  10  also preferably comprises of at least one pair of non-retractable handles  30  and  30 ′ (not shown) providing alternate means for picking up and carrying the container  10 . As shown in  FIGS. 1 &amp; 2 , the outer case  11  provides rings  31  and  31 ′ (not shown) for a shoulder strap  32  (not shown) to be attached for alternate means for picking up and carrying the container  10 .  FIG. 3  shows one embodiment of the invention where the shoulder straps are attached to the outer case  11 . In certain embodiments of the invention, an additional reinforced handle  33  (not shown) is attached to the top of the lid&#39;s exterior  22  providing yet another means for picking up and carrying the container  10 .  
         [0030]     As shown in  FIG. 1 , the outer case  11  may include at least one identification sleeve  21  which is adapted to secure and hold documentation concerning the blood or blood products being transported, which may include a patient&#39;s name, social security or identification number, physician, blood type, date the blood or blood product left the blood bank, scheduled date of delivery, number of units of blood being transported, delivery destination, etc. The identification sleeve  21 ′ is made of a clear or transparent plastic with an opening  24  adapted with a finger notch  25  for easy insertion and removal of documentation.  
         [0031]     As shown in  FIG. 2 , in one embodiment of the invention the outer case  11  has more than one identification sleeve  21 ,  21 ′, one on the side  15  of the outer case  11 , and the other on the lid&#39;s exterior  22 . It is understood by those practicing the arts that there can be as many identification sleeves  21 ,  21 ′ as desired. As shown in  FIG. 2 , the identification sleeve  21  may be secured to the side of the container  10  by anchor screws  27 ,  27 ′,  27 ″,  27 ′″, or any other securing means that are generally known and used by those skilled in the pertinent arts, including but not limited to, screws, nails, bolts, paste, glue and Velcro. The lid&#39;s exterior  11  is adapted for provision of any desired logo or other identification marks or notations.  
         [0032]      FIG. 1  depicts an outer case  11  adapted to form a receptacle area for an insulated layer  37  made of suitable insulation materials to shield the interior contents of the container  10  from external temperature. Suitable insulation materials may include a substantially rigid insulating material having a relatively low thermal conductivity and being relatively light weight, for example Minicel®, Volara®, Neoprene, Polystyrene (Styrene), Polyethylene, VIP (Vacuum Insulation Panel), ABS and Coroplast®, TempShield™ and SPACE AGE®. Preferably, the insulated layer  37  is formed from rigid polyurethane.  
         [0033]     The insulated layer  37  includes a bottom portion  38  (not shown) connected to walls  39  substantially surrounding the inner perimeter of the outer case  11 . The insulated layer  37  has a predetermined height to substantially engage or abut the top of the container  10  while substantially minimize the air space remaining above the container  10 . The outer case  11  also includes an insulation deck  40 , which may comprise of a PE plastic insert shaped to form a receptacle area  41  for the cooling elements  46 ,  46 ′,  47 ,  47 ′ (not shown). The insulation deck  40  substantially surrounds the insulated layer  37  and includes a bottom portion  43  (not shown) being connected to the walls  44  in a seamless well for spill proofing and to receive the cooling elements  46 . After the insulated layer  37  is placed in the outer case  11 , the insulation deck  40  is inserted in the outer case  11  and substantially engages the walls  39  and bottom portion so as to substantially seal the insulated layer  37  to the outer case  10 . In one embodiment of the invention, the insulation deck  40  is secured to the outer case  11  by anchor screws  45 . It is understood by those skilled in the arts that other securing means such as nails, glue, nuts and bolts may be applied to secure the insulation deck  40  to the outer case  11 .  
         [0034]      FIG. 4  depicts the cooling elements  46 ,  46 ′,  47 ,  47 ′ of the present invention, which is responsible for keeping the inner caddy  50  (not shown) at the required temperatures of 1° C. to 6° C. The cooling elements  46 ,  46 ′,  47 ,  47 ′ are made from strong, durable and lightweight material and comprises of at least four modular units with refrigerant material disposed within each modular unit. The cooling elements  46 ,  46 ′,  47 ,  47 ′ further comprise of two sides  46  and  46 ′ and a top  47  and bottom  47 ′. The two sides  46  and  46 ′ are sized and shaped to securely fit the interior sides of the insulation deck  40 , while the top  47  and bottom  47 ′ are sized and shaped to fit the bottom and top of the insulation deck  40 . The cooling elements  46 ,  46 ′,  47 ,  47 ′ further comprises of a receptacle area  48  (not shown) for receiving the inner caddy  50 .  
         [0035]     The cooling elements  46 ,  46 ′,  47 ,  47 ′ must first be properly frozen in a commercial or home freezer at temperatures set at or below −10° C. for a minimum of 24 hours, and then conditioned (allowed to stand at room temperature for 30-60 minutes after removal from the freezer) prior to use. If the cooling elements  46 ,  46 ′,  47 ,  47 ′ are already partially frozen, twelve (12) hours should prove sufficient. The cooling elements  46 ,  46 ′,  47 ,  47 ′ are stackable and easily stored in the freezer. The cooling elements  46 ,  46 ′,  47 ,  47 ′ must be refrozen before each day&#39;s use. Once the cooling elements  46 ,  46 ′,  47 ,  47 ′ are frozen and conditioned they are ready for insertion into the container  10 . The bottom  47 ′ is first placed in the bottom of the insulation deck  40  and the sides  46  and  46 ′ are inserted along the sidewall (not shown) of the insulation deck  40  forming a receptacle area  48  for the inner caddy  50 . After the inner caddy  50  is loaded and properly secured within the receptacle area  48 , then the top  47  is placed on top of the inner caddy  50 .  
         [0036]      FIG. 5  depicts one embodiment of the inner caddy  50  made to hold, transport and monitor the temperature of 1 to 6 units of blood or blood products at the required temperature range. The inner caddy  50  is constructed of clear, durable and lightweight material, such as Lucite or polycarbonate material or other like materials that are generally known and used by those skilled in the arts. However, it is understood that any clear, durable material of like properties that is known and generally used by those skilled in the arts may be employed. The inner caddy  50  is removable with cleaning vents  57  (not shown), allowing for self-drainage and easy cleaning. The inner caddy  50  comprises of a bottom portion  58  connected to walls  59 .  
         [0037]     Preferably, the inner caddy  50  defines a holding area  60  that can accommodate two or more units of blood or blood products at the required temperature range. As best seen in  FIG. 5 , holding area  60  is defined by sidewalls  80  (not shown), a front wall  81  (not shown), a back wall  82  (not shown), bottom portion  86  (not shown) and a middle divider  83 . To store a unit of blood or blood products in the holding area  60 , the unit is inserted in an upright position in between one of the straight side walls  80  and the middle divider  83 . The sidewalls  80  and middle divider  83  are sized and shaped to hold and secure a unit of blood or blood products placed between them.  
         [0038]     In one embodiment of the invention, the holding area  60  is adapted to hold 1 to 2 units of blood. In another embodiment, the holding area  60  is adapted to hold up to four units of blood. In yet another embodiment, the holding area  60  is adapted to hold six or more units of blood or blood products. The sidewalls  80  are hingedly connected to lids  85 ,  85 ′, which either extend outwardly open from the holding area  60  to form gull wings or from front to back (not shown). Each lid  85 ,  85 ′ is situated on an opposing side of the inner caddy  50 . In one embodiment, lifting means are provided for easy removal of the inner caddy  50  from the container  10 . Lifting means may include a handle, strap, tab, or anything that can be grasped or is generally known and used by those skilled in the arts. In one embodiment, lids  85 ,  85 ′ include an aperture  87  (not shown) adapted to receive the lifting means.  
         [0039]     In one embodiment of the invention, the lids  85 ,  85 ′ are adapted to receive tamper resistant security tags or clips. If the tamper resistant security tags are still in place at the destination address for the blood or blood products being transported, then the recipient can be assured that the blood or blood products was not removed from the container  10 . The tamper resistant security tags provide an effective means of ensuring compliance with certain protocols.  
         [0040]     As shown in  FIG. 5 , the inner caddy  50  provides for a receiving area  90 , which is sufficiently wide and deep enough to hold and secure the temperature data-logging device  91 . In the preferred embodiment, the receiving area  90  is secured to the front wall  81  of the inner caddy  50 . However, it is appreciated by those skilled in the arts that the receiving area  90  may be located anywhere on or near the inner caddy provided that the temperature data-logging device  91  is proximately located near the blood or blood units being transported for monitoring purposes.  
         [0041]     The temperature data-logging device  91  comprises of at least one probe  92  (not shown) for monitoring, collecting and reporting data concerning the blood or blood units being transported. The temperature data-logging device  91  is pre-programmable and can be adapted to monitor the temperature of the blood or blood products being transported for 24+ hours to meet the courier or recipient&#39;s protocols. In this manner, compliance and performance of the invention can be documented and verified.  
         [0042]     After the cooling elements  46 ,  46 ′,  47 ,  47 ′ have been frozen, conditioned and placed in the container  10 , the inner caddy  50  should be removed from the refrigerator with the units of blood or blood products and inserted into the receptacle area  48  formed by the cooling elements  46 ,  46 ′,  47 ,  47 ′ for receiving the inner caddy  50 . The temperature data-logging device  91  is now ready for monitoring and should be positioned in the receiving area  90  with its probe inserted in the holding area  60  at or near the units being transported. The temperature data-logging device  91  may be activated by swiping it with a start magnet. Thereafter, the temperature data-logging device  91  will continuously monitor the units of blood or blood products for up to 24+ hours. The temperature data-logging device  91  can be programmed to either transmit an alarm or a page if the temperature range is outside the set parameters.  
         [0043]     Further modifications and alternative embodiments of various aspects of the invention will be apparent to those skilled in the art in view of this description. Accordingly, this description is to be construed as illustrative only and is for the purpose of teaching those skilled in the art the general manner of carrying out the invention. It is to be understood that the forms of the invention shown and described herein are to be taken as the presently preferred embodiments. Elements and materials may be substituted for those illustrated and described herein, parts and processes may be reversed, and certain features of the invention may be utilized independently, all as would be apparent to one skilled in the art after having the benefit of this description of the invention. Changes may be made in the elements and compositions described herein or in the features or in the sequence of features of the methods described herein without departing from the spirit and scope of the invention as described in the following claims.