WO2007098244A2

WO2007098244A2 - Method and device for the transportation of temperature sensitive materials

Info

Publication number: WO2007098244A2
Application number: PCT/US2007/004612
Authority: WO
Inventors: Gerald H. Wilson
Original assignee: Healthcare Products International, Inc.
Priority date: 2006-02-21
Filing date: 2007-02-21
Publication date: 2007-08-30
Also published as: US20070193297A1; WO2007098244A3

Abstract

A temperature sensitive material is transported in an insulated container. The temperature sensitive material is enclosed ii an insulated container comprising a double wall container. The container has a front wall, a rear wall, two side walls, and a bottom wall, and insulation material in each of the regions between the double walls of said front wall, said rear wall, said two side walls, and the bottom wall. A double wall container cover has insulation material in the cover's double walls. A releasable hinge is provided and the container cover is releasably secured to the double wall container. A temperature sensing system is provided for monitoring the temperature within the container. The monitored temperature is stored in a temperature history database.

Description

Application for United States Letters Patent cf Gerald IV Wilson for TRANSPORTATION OF TEMPERATURE SENSITIVE MATERIALS

METHOD AND DEVICE FOR THE TRANSPORTATION OF TEMPERATURE SENSITIVE MATERIALS

CROSS-REFERENCE TO RELATED APPL OATJONS

[001] This application claims the benefit of provisional patent application 60/774,603, filed February 21 , 2006, for TRANSPORTATION OF TEMPERATURE SENSITIVE MATERIALS, the disclosure of which is incorporated hereby by reference as though recited in full.

BACKGROUND Field of the Invention

[002] The present invention relates generally to the transportation of temperature sensitive materials, and more particularly, to a system of transporting temperature sensitive materials, a method of transporting temperature sensitive materials, devices for transporting temperature sensitive mater ils, devices for maintaining the temperature sensitive materials within a required range, and to the monitoring of thermal history of the temperature sensitive materials that are transported.

Background of the Invention.

[003] There is a global need to ensure that every blood and organ donation is processed to respond to human needs globally and within the existing transportation conditions and requirements. The loss of valuable donated blood supplies due to careless handling, and/or poor packaging is estimated to be over 40%. This valuable donated blood is lost either to processing failure, transport inadequacies, carelessness, or even unintentional handling of materials as it they are being readied for human use. The current transport systems, however, fail to provide a comprehensive solution to the need to be able to respond to dynamic chan ;es and needs in the transport industry to reduce these losses.

[004] Temperature control is one of the most critical factors in successful blood and organ transport. There is a need to replace wet ice or dry ice, which is now restricted in air transport, with another more efficient, and safe coolant, at low cost.

[005] There is also a need to extend the time from 24 hours of safe temperature control to five or more days of safe temperature control. The longer time period would enable the global healthcare industry to meet response time requirements in emergency, military, and extraordinary civilian healthcare needs.

[006] There is a need to protect valuable cargo, such as blood, from the heat to which the vehicle or transport device in which is its being shipped, while on the tarmac of an airport.

[007] There is a need to maintain the valuable cargo within its safe temperature range, while being transported in regions where ele :*ricity is not readily available. Recent military actions in the Middle East, the tsunami in Asia, the hurricane Katrina, and the international interdependence of healthcare and disease control all bring into focus the need for a "State of Art" transport container for this c.itical supply.

[008] Paste board or corrugated box constructions with polystyrene and similar foam containers are cheap but have serious environmental problems.

[009] The 1950's beer cooler type of container filled with ice is common used, especially for whole blood units transported to aphaeresis centers that are typically in regional locations. There is a need for a system that reduces the time consuming and messy operation of loading ice and maintaining a stable temperature. Additionally, it is difficult to assure the sterility of ice that is us id as the coolant.

[0010]Complex transport units that contain battery operated controls for airflow, complex temperature monitors, and alarms are expensive, cumbersome, and deliver small payloads.

[0011] A semi disposable foil laminated insulated container was marketed that delivered 48 hours of temperature stability. The product line ajso included a battery operated unit for platelet transport up to 48 hours. The 48 hours of stabile control is insufficient to meet many if not most of the requirements in the global temperature sensitive transportation systems.

[0012] A sophisticated cooler is available with integrated electronics capable of PC readout. While it is a good product that pro\ des about three secure days of storage time, it is very expensive and three days of s corage time falls short of the needs of the industry. SUMMARY

[0013] According to a first broad aspect of the present invention, there is provided an insulated container for minimizing heat transfer between temperature sensitive materials and the environment through which the temperature sensitive materials are being transported.

[0014] According to a second broad aspect of the invention, there is provided packages of eutectic composition for use in maintaining temperature sensitive material within a required temperature range, during a period in which the temperature sensitive material is being subjected to a combination of extert al physical conditions that affect and influence temperature of the temperature se isitivu material.

[0015] According to another broad aspect of the invention, there is provided a monitoring system for establishing a thermal history of the temperature sensitive material that is being transported.

[0016] According to a further broad aspect of the invention, there is provided a transmitting system for transmitting to an external receiver, thermal information relating to the temperature sensitive material within a transportation container without exposing the temperature sensitive material to external physical conditions that affect and influence temperature or other physical properties of the temperature sensitive material that is being transported.

[0017] According to a further broad aspect c ; the invention, there is provided an identification system for identifying the temperature sensitive material that is being transported, for identifying the container within which the temperature sensitive material is being transported, and/or relative information relatng to the temperature sensitive material.

[0018] According to a further broad aspect of the invention, there is provided an identification system for identifying specifics about tht÷ temperature sensitive material that is being transported, to preclude misidentifying the temperature sensitive material.

[0019] According to a further broad aspect of the invention, there is provided a wireless identification system for remotely identifying the temperature sensitive material that is being transported. [0020] According to a further broad aspect of the invention, there is provided an identification system for identifying the temp-rature sensitive material that is being transported, for identifying the container within which the temperature sensitive material is being transported, and/or identifying other relative information relating to the temperature sensitive material without exposing the temperature sensitive material to ambient conditions, and for remotely accessing the identification system data.

[0021] According to a further broad aspect of the invention, there is provided an identification system for identifying the temperature sensitive material that is being transported, for identifying the container within which the temperature sensitive material is being transported, and/or identifying other relative information relating to the temperature sensitive material without exposing the temperature sensitive material to ambient conditions.

[0022] According to still another broad aspe< t of the invention, there is provided an identification system for identifying the temperature sensitive material that is being transported, for identifying the container within which the temperature sensitive material is being transported, and/or relative information relat ng to the temperature sensitive material, and for remotely accessing the identification system data.

[0023] According to a further broad aspect of the invention, there is provided an identification system for identifying the temperature sensitive material that is being transported, for identifying the container within which the temperature sensitive material is being transported, and/or identifying other relative information relating to the temperature sensitive material without exposing the temperature sensitive material to external physical conditions that affect and ι. -fluence temperature of the temperature sensitive material.

[0024] According to a further broad aspect of the invention, there is provided an identification system for identifying the temperature sensitive material that is being transported, for identifying the container within which the temperature sensitive material is being transported, and/or relative information relating to the temperature sensitive material, and for remotely accessing the identification system data.

[0025] According to a further broad aspect of the invention, there is provided a system and structure for raising or lower the temperature within the thermal barrier container within which the temperature sensitive material that is being transported, without exposing the temperature sensitive material to ambient conditions.

[0026] According to a still another broad aspect of the invention, there is provided a reusable system for use in maintaining temperature sensitive material within a required temperature range, during a period in which ^".he temperature sensitive material is being subjected to a combination of external physical conditions that affect and influence temperature of the temperature sensitive material.

[0027] According to another broad aspect of the invention, there is provided packages of disposable and/or replaceable containers of eutectic or other compositions for use in maintaining temperature sensitive material within a required temperature range, during a period in which the temperature sensitive material is being subjected to a combination of external physical conditions that affect and influence temperature of the temperature sensitive material.

[0028] According to another broad aspect of the invention, there is provided biologically safe reusable, disposable, and/or replaceab 9 containers of eutectic or other compositions for use in maintaining tempera are sensitive material within a required temperature range, during a period in which the temperature sensitive material is being subjected to a combination of external physical conditions that affect and influence temperature of the temperature sensitive material.

[0029] According to another broad aspect of the invention, there is provided a biologically safe reusable highly insulation efficient thermally insulating container for use in maintaining temperature sensitive material within a required temperature range, during a period in which the temperature sensitive material is being subjected to a combination of external physical conditions that affect and influence temperature of the temperature sensitive material.

[003O]In accordance with an embodiment o the invention an insulated container is provided for minimizing heat transfer between a temperature sensitive material and the environment through which the temperature sensitive materials atre being transported. The container is a double wall container, having a temperature sensing system, a front wall, a rear wall, two side walls, and a bottom wall. The region between the double walls of said front wall, said rear wall, said two side walls, and said bottom wall, are filled with a thermal insulation material. A double wall container cover is filled with insulation material and has a releasable hinge member is releasably secured to the double wall container by the releasable hinge.

[0031] In accordance with another embodiment of the invention, the temperature sensing system includes means for monitoring the temperature within said container, includes a temperature data recording member, and a database containing stored monitored temperature data.

[0032] In accordance with another embodiment of the invention, monitored temperature data is stored in a database and said data is transmitted to a receiver by means of a wireless transmitter.

[0033] In accordance with another embodiment of the invention, the container cover is filled with a eutectic mixture having a freezing point below that of water.

[0034] In accordance with another embodiment of the invention the container cover is filled with a eutectic mixture eutectic mixture of CaCI₂ and water.

[0035] In accordance with another embodiment of th€ invention at least five inserts are positioned within the container, proximate to the interior walls of the container. The inserts are dimensioned to fit within the insulated container and have dimensions, in combination, that are equal to or slightly less than the interior dimensions of the insulated container. The inserts and are filk i with a eutectic mixture having a freezing point below that of water. The eutectic mixti re can be NaCI or CaCI₂ and water, or a similar liquid and solid mixture, or a mixture of two or more liquids.

[0036] In accordance with another embodiment of the invention at least four of the inserts have substantially equal dimensions, and in combination, substantially match the interior wall dimensions of said container.

[0037] In accordance with another embodiment of the invention the space between the double side walls of each of two opposing sides of the container, and the rear double side walls is substantially uniform and free of recesses. Additionally, the front side of the container has a shallow recess into which a temperature data display member and a wireless transmitter for transmitting monitored temperature data unit is mounted.

[0038] In accordance with a further embodirr ent of the invention the spaces between the double side walls of each of two opposing sides of said container, and the rear double side walls are substantially uniform and free of recesses. Additionally, the front side of the container has a shallow recess a id a temperature data display member and a wireless transmitter for transmitting monitored temperature data unit mounted in the shallow recess. The temperature display member can display data visually, or by transmitting data to be displayed to a remote member that includes a visual display.

[0039] In accordance with another embodiment of the invention the container has a flange region that extends upwardly from each side wall and forms a "LT-shaped channel at the top of the container. The said container cover is positioned within the "U"-shaped channel. Preferably, hand holds are formed in each of the flange regions. The hand holds can comprise finger receiving openings in the flange regions and can have a convex outwardly facing surface.

[004O]In accordance with another embodiment of the invention the releasable hinge means comprises a cylindrical shaft membe; extended from opposite sides of said cover, and a curved channel in each of said flange regions. The curved channels are open at the upper edge of the flange regions, extend toward the rear edge of the flange regions, and are closed at the rear edge. Each cylindrical shaft member is mounted for rotary movement in the curved channel, and is removable from the curved channels via the open upper edge of said curved channel. The curved channels can be in the form of an "L", with the short leg of the "L" having an open^'end and the long leg of the "L" having a closed end.

[0041] In accordance with still another embodiment of the invention the releasable hinge means comprises a cylindrical shaft member projecting inwardly from each of the flange regions, and a curved channel is pro\ ded in the side walls of the cover. The curved channels are open at the lower edge of the crtver, extend toward the rear edge of the cover, and are closed at the rear edge. Each cylindrical shaft member is mounted for rotary movement in a curved channel, and is removable from the curved channels via the open end of said channel. The curved channels can be in the form of an "L", with the short leg of the "L" having an open end and the long leg of the "L" having a closed end.

[0042] In accordance with another embodiment of the invention means are provided to snap the cylindrical shaft members in place at the rear, closed ends of the channels.

[0043] In accordance with a further embodiment of the invention a locking member is provided for locking the cover to the contain /r, when the cover member is in place within the "U" shaped channel and the rear edges of the cover is at the rear edge of the flange regions. The locking member precludes the cover from being removed from said container by preventing rotation of the cover about said releasable hinge.

[0044] In accordance with another embodim nt of the invention the interior of the container has an interior ridge proximate the upper edge of the interior walls of the container, and the ridge forms a longitudinal channel to receive an interior lid member, and hold the lid member in place. Preferably, the lid member is a double wall member filled with a eutectic mixture. The insulated container cover preferably, forms a rabbet joint with the open end of the walls of the insulated container.

[0045] In accordance with another embodiment of the invention the cover upper side and the container bottom wall have a mating recess and ridge. The recess and ridge have asymmetrical configurations, such that the cover of a first container mates with the bottom of another container in only one configuration, wherein the front wall of the first container and the front wall of the another container, lie in substantially the same plane.

[0046] In accordance with another embodiment of the invention at least four insert members are dimensioned to fit within the insulated container and have length, width, and height dimensions, that in combination, are equal to or slightly less than the interior wall dimensions of said insulated container. The inserts are filled with a eutectic mixture having a freezing point below that of water. The width of each of the at least four inserts is at least one inch, and the width plus the length of at least four inserts are equal to or slightly less than the interior wall dimension of the container

[0047] In accordance with another embodiment of the invention a method of transporting a temperature sensitive material comprises enclosing the temperature sensitive material in a double wall insulated container. The container has a front wall, a rear wall, two side walls, and a bottom wall, nsulation material in each of the region between the double walls of said front wall, said rear^'wall, said two side walls, and said bottom wall, a double wall container cover, and insulation material in the container's cover's double walls. Preferably, the container has a releasable hinge for releasably securing the container cover to the double wall container. The container further includes a temperature sensing system. The temperature within the container is preferably monitored from the time the temperature sensitive material is inserted into the container until the temperature sensitive material is to be removed from the container. The monitored temperature data is stored in a database. Preferably, the stored temperature data is wirelessly transmitted a data receiver by an RF transmitter or other wireless transmission means, now known, or which may hereinafter be known.

[0048] In accordance with another embodiment of the invention the temperature sensitive material is maintained at a sub-ambient temperature by the enthalpy fusion of a frozen eutectic mixture within the walls of said container.

[0049] In accordance with another embodim nt of the invention a temperature sensitive material is maintained at a stable temperature by means of a high heat capacity mixture within the walls of said container which insulates the temperature sensitive material from temperature fluctuations.

[005O]In accordance with another embodiment of the invention the temperature sensitive material is maintained within a predetermined temperature range within said container by enclosing the temperature sensitive material within a padded, filled, pouch member sealed in the manner of a quilt, the member being filled with a eutectic mixture.

[0051] In accordance with another embodiment of the invention the temperature sensitive material is maintained within in a predetermined temperature range within the container by covering the temperature sensi ive material with a padded, filled, blanket member sealed in the manner of a quilt, the .nember being filled with a eutectic mixture.

[0052] In accordance with another embodiment of the invention a method of transporting a temperature sensitive material comprises enclosing the temperature sensitive material in an insulated container. The container has a releasable hinge for releasably securing a container cover to the container. The container cover is filled with a eutectic mixture and the container further includes a temperature sensing system. The cover is separated from the container, placed within a refrigerated unit, and the eutectic mixture in cover is frozen and/or maintained in a frozen state. The cover is replaced on the container and the temperature sensitive material is housed within the container. The container with its cargo of a ^femperafure sensitive material is then transported to a desired destination.

BRIEF DESCRIPTION OF THE DRAWINGS

[0053]The invention will be described in conjunction with the accompanying drawings, in which: [0054] FIG. 1 is a perspective view of a standard container in accordance with an embodiment of the present invention;

[0055] FIG. 2 is a plan view of the top of the container in accordance with an embodiment of the present invention;

[0056] FIG. 2A is a front view of the locking recesses in accordance with an embodiment of the present invention;

[0057] FIG. 3 is a plan view of the bottom of the container in accordance with an embodiment of the present invention;

[0058] FIG. 4 is a perspective view of the bo^om of a standard container in accordance with an embodiment of the present invention,

[0059] FIG. 5 is a plan view of the front of the container in accordance with an embodiment of the present invention;

[0060] FIG. 6 is a perspective view of the back of the container with the lid open in accordance with an embodiment of the present invention;

[0061] FIG. 7 is a perspective view of the side rim of *he container and hinge in accordance with an embodiment of the present invention;

[0062] FIG. 8 is a perspective view of the side of the container lid in accordance with an embodiment of the present invention;

[0063] FIG. 9 is a side view of the refrigeran tray in accordance with an embodiment of the present invention;

[0064] FIG. 10 is a perspective view of the refrigerant tray of FlG. 9 in accordance with an embodiment of the present invention;

[0065] FIG. 11 is a perspective view of the interior of the container in accordance with an embodiment of the present invention;

[0066] FIG. 12 is a cutaway perspective view of the double walls of the container, in accordance with another embodiment of the present invention;

[0067] FIG. 13 is a perspective view of an eutectic refrigerant pad for use in the container, in accordance with another emboϋment of the present invention; [0068] FIG. 14 is a perspective view of a vacuum sealed, eutectic refrigerant pad having indicators showing that the vacuum is not lost, in accordance with another embodiment of the present invention;

[0069]

[0070] that has been air evacuated; FIG. 15 is a perspective view of the eutectic refrigerant pad of FIG. 14, show after the integrity of the pad has been breeched and the vacuum lost.

[0071] FIG. 15 is a is a perspective view of a rectangular container with the placement of single sized heating or cooling panels, in accordance with another embodiment of the present invention;

[0072] FIG. 16 is a is a perspective view of the standard container with the placement of single sized heating or cooling panels, in accordance' with another embodiment of the present invention;

[0073] FIG. 17 is a plan view of a refrigerant blanket having a plurality of pockets filled with a eutectic mixture, in accordance with an embodiment of the present invention;

[0074] FIG. 18 is an end view of the refrigerant blanket of FIG. 17 having a plurality of rows and columns of pockets filled with a eutectic mixture, in accordance with an embodiment of the present invention;

[007S]FIG. 19 is a plan view of a refrigerant panel having a single column of pockets filled with a eutectic mixture, in accordance with an embodiment of the present invention;

[0076] FIG. 20 is a plan view of blood contaⁱner in accordance with an embodiment of the present invention;

[0077] FIG. 21 is a plan view of an insulated cover fo¹" the blood container of FIG. 20, in accordance with an embodiment of the present invention;

[0078] FIG. 22 is a plan view of an insulated cover with the blood container of FIG. 20 in the cover, in accordance with an embodiment of the present invention; and

[0079] FIG. 23 is a cross-sectional view of a secondary container for housing, for example, a human organ, in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION [008O]It is advantageous to define several terms before describing the invention. It should be appreciated that the following definitions are used throughout this application.

Definiϋons

[0081] Where the definition of terms departs Trom the commonly used meaning of the term, applicant intends to utilize the definitions provided below, unless specifically indicated.

[0082] For the purposes of the present invention, the term "eutectic" refers to a composition of a mixture having the lowest possible temperature of solidification of the specified constituents of the mixture. A salt water mixture, for example, eutectic point for a water-salt mixture is -21.12° C (-6.02° F), as compared to 0° C or 32° F.

[0083] "Latent heat" means the quantity of heat absorbed or released by a substance undergoing a change of state, such as ice changing to water, or water to steam, as constant temperature and pressure.

[0084] For the purposes of the present inver^sion, the term "refrigeranf means a substance such as air, ammonia, water, or carbon dipxide by direct absorption of heat. The substance can be a eutectic mixture or other substance that has a required freezing point. Preferably, the refrigerant has a high latent heat and require a substantial amount of heat to go from its solid state to its liquid or gaseous state.

[0085] "Freezing point" means the temperature at which the liquid refrigerant solidifies under a specific pressure, which is normally, ambient pressure.

[0086] For the purposes of the present invention, the term "wireless" refers to any suitable electronic device for transmitting data from sensors and data collectors to readout devices, and the like. The system of U.S. Patent 6,490,443 is representative of one such system. Alternatively, it can be a chip that is not self powered, but rather is activated by a signal from a remote data rea ier.

Description

[0087]The container is made by plastic blow molding or any other means for forming a double wall container, as well known in the art, or as may become known in the future. Preferably, the container surface has a matte finish. The surface is moderately textured since excessive texturing of the surface can render the surface difficult to clean, sanitize, and/or sterilize. Insufficient texturing of the surface makes it too difficult to remove labels that are placed on the container for identifying the shipment. Moderate texturing is just sufficient to be sensed by a user's finger and to be visible to the naked eye. Moderate texturing of the surface can be in the form of a moderate matte finish, dimples, surface crinkles, wrinkles, fine waves, other slightly raised surface. A moderate texturing is characterized by having sufficient irregularity to limit the surface contact between the label adhesive and the plastic surface of the container thereby facilitating or enabling complete removable of labels. Moderate texturing is further characterized by having crevices or surface regularities that are not of such depth or so pronounced as to harbor bacteria or other infectious organism while providing sufficient surface contact area to prevent inadvertent release of the label from the container. Preferably, the combination of surface texture and adhesive provides some what less than an adhesion level that inhibits or precludes complete removal of the label from the container. ~^:~ <^■„-.

[0088] It should further be noted that the system disclosed herein can maintain the initial temperature for approximately eight hours. This applies to ambient temperature, the temperature required for the initial shipping of blood, to sub-zero temperatures.

[0089] The present invention provides a double wall container, indicated generally as 100, in FIG. 1. The area between the conta ier exterior wall 104 and interior wall (not shown) is filled with an insulating material, preferably, a closed cell insulating foam, such as the blown insulation used in home insulation. The side lid receiving rims 160A and 160B extend above the body 108 of the container 100 on opposing sides to receive the lid 130. The front panel 138 and back panel 139 of the lid 130 rest on the front lip 110 and back lip 111 (not shown) of the body 108, between the side lid receiving rims 160A and 160B. The handles 120A and 120 are recessed into the side lid receiving rims 160A and 160B, respectively, to enable easy carrying and will be described in further detail hereinafter.

[0090] The lid 130 has a recessed receiving area 132 which has an aligning angle 134 to interact with the bottom of additional containers 100 to be stacked to ensure that all containers 100 are aligned property. The a cjnment of the containers 100 will be disclosed in detail hereinafter. [0091]To prevent the lid 130 from opening 'ι 30° a pair of stops 136A and 136B are placed on the back panel 139 of the lid 130. The stops 136A and 136B connect with the back lip 111 (FIG 6) to prevent the lid 130 from opening further than a predetermined distance. The stops 136A and 136B are raised areas having a height sufficient that it limits the rotation of the lid 130 about its pivot point. That is, the stops 136A and 136B must project into the path of the lid 130 such that the lid 130 cannot rotate 180°. If the lid can rotate too far, then further rotational pressure on the may break the pivot or hinge mechanism. The width of the stops 136A and 136B is not narrowly critical and the height of the stops is determined by the relative dimensions and positions of the lid and pivot. Preferably, the lid 130 opens beyond 90° before being prevented from further movement by the stops 136A and 136B. Generally, rotation of the lid should be greater that 90° >ut less than 135°. The placement and size of the stops 136A and 136B can be altered to permit a greater or lesser angle of opening based upon the application. Additionally _y although two stops 136A and 136B are illustrated herein, a single centered stop or more than two stops can be provided.

[0092JThe lid 130 is shown from the top in Fig. 2, clearly showing the handles 120A and 120B, as well as the dimensioning of the stops 136A and 136B. As see here, the stops 136A and 136B extend from the edge of the lid 130 to the recess 132. The angle of the aligning angle 134 can also Be easily seen in this Figure. It should be noted that although an angle is used in this embodiment, any other design, protrusion or other method of ensuring that the containers 100 are placed in the same direction as they are stacked can be used. ' ^l"

[0093] The lid lock recess 140 and lock bar I ole 142 can also be seen more clearly in this and Figure 2A. The alignment between the lock bar hole 142 and bar receiving hole 113 is critical to enable a lock to pass through without binding. Likewise, the body lock recess 112 should be aligned with the lid lock recess 114 to maintain the smooth surface of the container 100. In the preferred embodiment the lid lock recess 140 and the body lock recess 112 are smooth, curves recesses with no corners for the accumulation of bacteria.

[0094]The front panel 138 of the lid 130 contains the lid lock recess 140, lock bar hole 142 and the recessed handle 144. The recessed handle 144 illustrated herein is centered within the lid 130, however the recessed handle 144 could be moved to one side or the other if desired. The lid lock rect =s 140 is dimensioned to receive a portion of a small lock to maintain the container 100 locked during transport. Below the lid lock recess 140 is the lock bar hole 142. Within the front 108 of the container 110 is the body lock recess 112 and lock bar hole 114 (not shown). The body lock recess 112 and the lock bar hole 114 are aligned directl beneath the lid lock recess 140 and lock bar hole 142 to enable a lock to be easily recessed. Alternatively, a locking system can be build directly into the container 100, however as all surfaces must be easily cleaned when used in medical application, the lock would need to be covered to prevent bacteria growth. In non-medical applications the lock would not need to be as carefully designed.

[0095]The front 108 of the container 100 also contains the electronic recess 180 and probe wire receiving area 182. The probe wire receiving area 182 is dimensioned to receive a probe connected to the electronics package. The probe extends into the interior of the container from the back of the electronics package. This prevents any change in the interior temperature due to air seepage. The probe monitors temperature fluctuations or migrations within the contain* '' sending the data to a microprocessor where it is recorded. The data is stored for retrial remotely by satellite, by a reader that reads the data when in the proximity of the data storage device, by infrared transmissions, optical readers, Bluetooth wireless transmission, or similar system now in commercial use or which come into use at a future date. The electronics package consists of components that are well known in the art.

[0096] Alternatively, or additionally, the data can be read by a hard wire connection to a PC. The connector 808 can be a USB port, serial port, firewire port, or other comparable data communication port, now in use or that comes into use at a future date. Additionally, a visual display can be provided for facilitating monitoring the temperature at the product being shipped.' Λ parameter that is essential to monitor is the opening of the container. Violating the s jalincj of the container must be readily determined as part of the system for maintaining the product temperature and assuring product integrity. If the lid is opened, even momentarily, there will be an immediate temperature rise within the container. Sensing a high temperature spike signals that the lid has been opened and ambient air has been permitted to enter the container. The integrity of the temperature of the product being shipped, as for example, whole blood, blood plasma, or an organ, would likely be unaffected by the temperature spike, and a temperature sensor that monitors the product temperature would not reveal the temperature of the spike unless it is positioned to be sensitive to the air temperature within the container. A separate internal air temperature monitor can be provided or, alternatively, the product temperature sensor can have the dual function required.

[0097] When transporting biological materials, there is a maximum and a minimum temperature that is acceptable during the transportation stage. In many instances, if the temperature falls beiow that range the ability to use the materials may be compromised. In the disclosed system, the υrocessor reads and stores the temperature from the probe and stores the tine and temperature. If the temperature rises above the temperature set, an alarm is activated. Preferably this alarm is visual only; however in some applications the alarm can be visual and/or audible. Whether the data is read from the processor only if the alarm has been activated, or if it is always read is dependent upon the user and the protocol for the materials being transported. Additionally, the handling of the material subsequent^'to exposure to higher temperatures than programmed is a matter of protocol. The temperatures and the temperatures range are dependent upon the type of biological material and will be known to those skilled in the art.

[0098]The microprocessor within the electronics package preferably has the ability to receive data from an external source, theret •/ permitting the bar codes of the materials being transported to be scanned and stored'within the processor. This information is then retrieved upon delivery and can be compared with hard records, contents, etc.

[0099] The bottom 200 of the container 100, illustrated in FIGS. 3 and 4, has a base 202 with a locking rim 204 that is dimensioned slightly less than the recess 132 of the lid 130. The locking rim 204 interacts with the recess 132 of an adjacent container 100 to prevent the stacked containers 100 from sliding off of the adjacent bottom container 100. To ensure that the containers 100 are all facing the same direction, the locking area 204 has an angled offset 212 that corresponds to the aligning angle 134 on the lid 130. The depth of the locking area 204 must be equal to the depth of the recess 132 to enable stable interaction between the stacked containers 100. To accommodate the stops 136A and 136B, recesses 206A and 2 iSB εre placed in the base 202. In addition to enabling the containers 100 to sit^'flat upoh one another, the interaction between the stops 136A and 136B and the recesses '206A and 206B further prevents sliding of the stacked containers. [00100] The front of the container 100 is illustrated in FIG. 5 wherein the dimensioning of the elements can be seen more clearly. The container 100, must for shipping and storage reasons, have a straight sides and backs without any protrusions. This enables the containers 100, whatever dimensions and configurations are being used, to be stored and stacked compactly. To maintain this smooth appearance, the lid 130 has a slightly small periphery than the periphery .of the container 100. This change in dimension enables the handles 120A and 120B to be rounded and still be within the periphery of the container body 108. The locking rim 204 is also seen in this Figure extending beyond the bottom of the container body 108. It is critical that, as the weight of the container 100 rests on the locking rirn 204, that the locking rim 204 provides a sufficiently wide base to prevent tipping. Tϊ ? stoos 136A and 136B are seen extending above the top surface of the top 130. The_;ιalignment of the lid lock recess 140 and body lock recess 112 is also easily seen in this figure. Although the lid lock recess 140 and body lock recess 112 in this embodiment are positioned adjacent to the handle 144, the location of the lid lock recess 140 and body lock recess 112 can be moved. It is critical that the lid lock recess 140 and body lock recess 112 be recessed within the container body 108 to maintain the smooth exterior surface.

[00101] The interaction between the' stops 136A and 136B is illustrated in Figure 6 wherein the lid 130 is shown in the open position. As can be seen the stops 136A and 136B contact the back rim 111 , preventing the lid 130 from opening further. As noted heretofore, the stops 136A and 136B can be dimensioned and positioned to enable the lid 130 to open to any degree.

[00102] The lid 130 is design to be capable of being separated from the body 108 of the container 100. In this manner, lids can be refrigerated and maintained at their desired temperature. While the container 100 is too large for it to be practical to refrigerate, having the lid 130 stored at the required temperature enables a user to assemble a container 100 that is immediately at its required temperature.

[00103] In order to remove the lid 130 while still maintaining the desired profile and sterilization ability, the container 100 and top 130 are designed to interact with one another through a slide and locking system within the side lid receiving rims 160A and 160B. In Figures 7 and 8 the slide recess 702 is shown molded into the side lid receiving rim 160B. The slide recess 702 et ds at receiving area 704 that is dimensioned to receive the button 802 of the lid 130. The receiving area 704 has a rim 706 that is slight raised to maintain the button 802 within the receiving area 704. This design is one embodiment of how the lid car be removably affixed to the container 100 and other designs will be evident to those si- i'ed in the art.

[00104] The lid 103 also has a protrusion 806 that interacts with the snap lock

724 that consists of an entry area 720 and rim 722. This serves as a friction locking system for the container 100, preventing the lid 130 from inadvertently opening prior to locking.

[00105] The refrigerant tray 900 is illustrated in Figures 7, 9 and 10. The refrigerant tray 900 is dimensioned to sit within the lo/ver rim 1002 (FIG. 11 ) of the container 100, illustrated in Figure 10. The top surface 902 of the refrigerant tray 900 has a recessed handle 910 and concave strips 906 extending from front to back. The concave strips 906 provide additional surface area to enhance freezing. The shape and size of the concave strips 906 as illustre ,ed is for example only and other configurations can be used. The refrigerant tray 900 is fill with refrigeration material appropriate for the temperature level desired and wilj be evident to those skilled in the art. The bottom of the refrigerant tray 900 (not shown) can contain recesses and other structural element to maintain its integrity.

[00106] The interior of the container 100 is illustrated in Figure 11 showing the front lip 110 and lower rim 1002. The lower rim 1002 extends into the interior of the container 100 to provide the support for the refrigerant tray 900. A finger notch 1004 is provided in the lower rim 1002, extending into the front panel 1006, to enable the user to life up the refrigerant tray 900.

[00107] To contribute to the maintenar ~e of the consistent temperature, the container 100, as illustrated in Figure 12, is > ;.anu^factured with a double wall, exterior side walls 1202 and interior side walls 1204. Additionally, the exterior base 1208 is spaced from the inner base (not shown). The space between the exterior side walls 1202, interior side walls 1204, exterior base 1208 and inner base is filled with insulation to maintain the initial temperature. It should be noted that the none of the recesses on the container 100 are placed in the double walls. By placing all recesses, lock, handles, etc. above the double walls, the Interior temperature is not compromised.

[00108] To further insure that the contents of the container 100 are kept at the desired temperature, vacuum sealed refrigerant pads 1400 and 1300, illustrated in Figures 13 and 14 are used. The refrigerant pads contain an open cell, hygroscopic foam and a eutectic mixture such as NaCI, CaCI₂, Kl₁ and related members of the sodium and halogen groups. The refrigerant pads can be capable of providing eight hours of stable temperature under normal circumstances or eight days of stable temperature in the system of the present invention. Preferably, the pads and containers are dimensioned such that all pai s are the same size. Pads can be color coded to indicate their eutectic temperature to easily. select a correct pad corresponding to the required storage temperature of the system.

[00109] Alternatively, as Illustrated in Figure 14, a eutectic pad 1400 can be used. The open cell hygroscopic foam within the container can be provided with embossed indicia 1402. When the pad 1400 is evacuated, the outer sleeve 1404 is pulled tightly against the open cell foam and is pulled into the embossed region. When the sleeve is forced to conform to the shape of the open cell foam, the sleeve displays the indicia 1402 that indicates that the integrity of the pad has not been breeched. Conversely, when the outer sleeve 1404 is punctured or otherwise is no longer air tight, the vacuum is lost that the sleeve 1404 relaxes. When fe sleeve 1404 is no longer sucked into the embossed indicia 1402, the indicia 1402 is r.ύ longer visible. When this happens, the pad 1400 is replaced.

[00110] In the square container the refrigerant pad 1300 pattern of FIG. 16 can be used, such that pads 1300 are of equal size. In a rectangular container, as illustrated in FIG. 15, the end pads 1300 extend the full length of the interior of the container end wall 1504 and the side pads '1300 extend between the ends pads 1300. In this manner, all of the refrigerant pads 1300 can be of the same dimensions and accordingly, interchangeable. Having all five pads of the same size negates the possible of using a wrong size, or being out of supply of a particular size.

[00111] FIGS. 17-19 show a refrigerar+ blanket indicated generally as 1700, having a plurality of eutectic containing cells ''702 separated by seal lines 1704. The end view of the blanket 1700, illustrated in FlG 18, shows more clearly the cells 1702 separated by seal lines 1704. FIG. 19 shows a refrigerant unit indicated generally as 1900 and having a column of eutectic cells 1902. Additionally, the refrigerant element can be a single cell. Refrigerant elements such as illustrated in Figures 17 — 19 are used to fill the otherwise unoccupied space within the shipping container and provides product protection, cushioning, and additional refrigeration. [00112] Figure 20 shows a blood container 2000 that requires storage at a predetermined subzero degree C. temperature. The container 2000 can be provided with a plurality of bar codes, such as 2002 and 2004, and thus readily scanned to provide required data and inventory control. The remote system can be as disclosed and described in U.S. Patent 6,991 ,160, the disclosure of which is incorporate herein by reference, as though recited in full.

[00113] FIG. 21 shows an insulated, or preferably, a refrigerant container 2100 dimensioned to receive the blood container ?000, as illustrated in Figure 22. The cells 602 are preferably filled with a eutectic mixti 3 to provide a subzero refrigerant component that preferable has a high latent heat or heat of transformation, and a required low freezing point.

[00114] In some embodiments, an additional container is used to provide increased refrigeration. FIG. 23 is a cross-sectional view of a container that is employed within the primary shipping container. The secondary container has its own refrigerant component and is capable of maintaining a human organ at the required subzero temperature, during the period in which the organ is transferred from the shipping container to an operating room an awaits being incorporated into a human being. The container indicated generally as 2300 is a double wall unit having an outer wall 2304 and an inner wall 2302. The spac J between the inner and outer walls is filled with a eutectic mixture or other refrigerant 21.06, and 'can provide up to about eight hours of organ storage time, to accommodate the time that it takes to transfer the organ from its primary location to the shipping container, and from the shipping container to an operating room. The padded shipping container 2320 protects the organ and can be similar in design to the shipping sleeves or covers of FIGS. 13 and 14.

[00115] FIG. 24 is a temperature regulated transportation system, indicated generally as 100. The shipping container system includes refrigerant pads 1300 as previously described, and the container is a double wall structure filled with an open cell hygroscopic insulator, a closed cell insulating foam, or other insulating material.

[00116] The maintenance cost of the shipping system is reduced and the life of a system is prolonged by virtue of the ability tc jeplcce damaged, soiled, or otherwise unusable components. Conversely, damaging a component of a structurally integrated system requires total replacement of the unit. The disposable components include the lid and its refrigerant unit, eutectic pads (2O ι, and the absorbent pads (1306). In the designs where the electronic components are housed in the lid, defective electronic can be replaced without replacing the entire system.

[00117] Specification Details

[00118] The following size and other considerations are provided for reference rather than by way of limitation.

[00119] The pallet sizes routinely used here in the USA are 40X48 inches. The sizes of the common EU metric pallets are 800x1000mm. While there are other possible dimensions, the container configuration should both maximize the number of units in the layer and stack to provide a com ?ined dimension of under the 96 inches for cargo and 48 inches for warehouse requirements.¹ .

[00120] The HPI temperature sensitive transportation product is sized for the internal element needs, payload, and finally best possible fit to the EU pallet. Leaving pallet space unused would not be as negative as "overshoot'. In some markets pallets are less likely to be using in shipping. Single shipments are the norm. The preferred exterior size of HPI TSTD is 16x16x18.5 inches. The exterior size may be less but preferably is not greater than the preferred dimensions.

[00121] Maintaining an interior square payload area is important for the suggested fitting of the insulation/eutectic pads. The taper of the interior should be minimized to insure best side fitting of the pads in the cor^guration suggested so that all panels will be equal in size for the sides. The interior p.iyload area is 14x14x14.5 inches.

[00122] The vacuum sealed pads of specialty foam for the sides are preferably sized at 11.5x11.5x.1.5 inches. They are fitted to overlap at the comers and not be skived or fitted. The base panel of same construction is 13x13x1.5 inches, which allows for some taper in the payload area. The top liquid filled foam panel measures 13.5x13.5x2 inches. This leaves a payload area of 10.5x10.5x12 inches which provides space for a pack of 16 units of whole blood and plasma.

[00123] The exterior of the shipping container has side handles built into the container. Preferably the side handles are not in the side walls of the container, but rather are above the side walls, such that th^ side walls are free of recesses that can produce a region of reduced thermal insulation. Add on floppy handles is avoided for cleanliness and stacking purposes. The interface between the lid and base allows for a tape seal, and has a locking device to accommodate a security band or padlock. The temperature data display is preferably visiblr from a side, most preferably the front side, rather than from the top due to stacking of containers obscuring the top surface.

[00124] An electronic access plug for hardwire connections is preferably proximal to the data display. Logo stick-on labels can be used to give flexibility for private label contracts.

[00125] The color of preference is either dull orange or tan. Colors such as blue, black, or white are preferably not used because of a need to provide a distinctive color and wipe-down convenience.

[00126] The lid is preferably breakaway, or releasably hinged and easily opened once the tape seal is broken.

[00127] The wall thickness should be ε - any point no less than 1.5 inches and have filler ports for adding internal foam insulation. The filler ports preferably are internal or on the bottom of the container for appearance.

[00128] All documents, patents, journal articles, and other materials cited in the present application are hereby incorporated by reference.

[00129] Although the present invention has been fully described in conjunction with several embodiments thereof with reference to the accompanying drawings, it is to be understood that various changes and modifications may be apparent to those skilled in the art. Such changes and modifications are to be understood as included within the scope of the present invention as defined by the appended claims, unless they depart there from.

Claims

1- An insulated container for minimizing heat transfer between a temperature sensitive material and the environment through which the temperature sensitive materials are being transported, comprising a double wall container; said container having a front wall, a rear wall, two side walls, and a bottom wall, insulation material in each of the regions between the double walls of said front wall, said rear wall, said two side walls, and said bottom wall, a double wall container cover, insulation material in said container's cover¹:' double walls, . releasable hinge member, said container cover being releasably secured to said double wall container by said releasable hinge means, and a temperature sensing system.

2- The insulated container of claim 1 , wherein said temperature sensing system comprises means for monitoring the temperature within said container, a temperature data recording member, and a database containing stored monitored temperature data.

3- The insulated container of claim 1 , further comprising wireless transmitter for transmitting monitored temperature data.

4- The insulated container of claim 1 , wherein said container cover is filled with a eutectic mixture having a freezing point below that of water.

5- The insulated container of claim 1 , wherein said eutectic mixture is CaCI₂ and water. ^{• ■■}

6- The insulated container of claim 1 , further comprising at least four inserts dimensioned to fit within said insulated container and having dimensions, in combination, equal to or slightly less than the interior front, rear, and side wall dimensions of said insulated container, and /herein said inserts are filled with a eutectic mixture having a freezing point belo/v that of water. 7- The insulated container of claim 6, wherein at least four of said inserts have substantially equal dimensions, and in combination, substantially match the interior wall dimensions of said container.

8- The insulated container of claim 6, wherein said eutectic mixture is CaCI₂ and water.

9- The insulated container of claim 1 , wherein the spaces between the double side walls of each of two opposing sides of said container, and the rear double side walls are substantially uniform and are free of wall recesses that protrude into said spaces between the double side wails of each of tw< opposing sides of said container, and the rear double side walls <- , '

10- The insulated container of claim 1 , wherein the front side of said container has a shallow recess, and a temperature data display and said wireless transmitter for transmitting monitored temperature data unit is mounted in said shallow recess but is otherwise free of wall recesses that protrude into said spaces between the double front walls.

11 - The insulated container of claim 1 , wherein said container has a flange region upwardly extending from each side wall and forming a ^uU"-shaped channel at the top of said container, said container cover being positioned within said "U"-shaped channel.

12- The insulated container of claim 11, further comprising hand holds formed in each of said flange regions.

13- The insulated container of claim 12, wherein said hand holds comprise openings in said flange regions and have a convex outwardly facing surface.

14- The insulated container of claim 11 , wherein said releasable hinge means comprises a cylindrical shaft member extended from opposite sides of said cover, and a curved channel in each of said flange regions, said curved channel being open at the upper edge of said flange regions, extend tc vard the rear edge of said flange regions, and are closed at said rear edge, each cylindrical shaft member being mounted for rotary movement in said curved channel, and being removable from said curved recesses via the open upper edge of said curved recesses.

15- The insulated container of claim 11 , wherein said releasable hinge means comprises a cylindrical shaft member projecting inwardly from each of said flange regions, opposite sides of said , and a curved channel in , said curved channels being open at the lower edge of said cover, and extend toward the rear edge of said cover, and being closed at said rear edge, each cylindrical shaft member being mounted for rotary movement in said curved channel, and being removable from said curved recesses via the open end of said channel:

16- The insulated container of claim 14, further comprising means to snap said cylindrical shaft members in place at the rear edges of said flange regions.

17- The insulated container of claim 14, ftfrther comprising a locking member for locking said cover to said container, when said coven member is snapped in place at the rear edges of said flange regions, whereby said locking member precludes the cover from being removed from said container and prevents rotation of said cover about said releasable hinge.

18- The insulated container of claim 1.-.wherein the interior of said container has an interior ridge proximate the upper edge of the interior walls of said container, said ridge forming a longitudinal channel to receive an interior lid member, and hold said lid member in place, said lid member being a double wall member filled with a eutectic mixture. ι.'^{v •} n-

19- The insulated container of claim 18, wherein said cover forms a rabbet joint with the open end of the walls of said insulated container..

20- The insulated container of claim 1 , wherein said cover forms a rabbet joint with the open end of the walls of said insulated container.

21- The insulated container of claim 1, wherein said cover upper side and said container bottom wall have a mating recess and ridge, said recess and said ridge having asymmetrical configurations, whereby the cover of a first container mates with the bottom of another container in only one configuration, such that the front wall of said first container and the front wall of said another container, lie in the same plane.

22- The insulated container of claim 14, further comprising at least one flange on the upper surface of said cover, said at least on . flange being positioned and dimensioned to extend into the rotational path of said covυr and limit the degree of rotation of said cover about said cylindrical shaft member.

23- The insulated container of claim 1 , wherein said double walled container and said double wall cover are blow-molded.

24- The insulated container of claim 11,. wherein said flange regions extend substantially from the front wall to the rear wall of said container and from said container upper edge to the top of said cover, when said cover is locked in place on said container. •.

25- The insulated container of claim 7, wk.«rein the width of each of at least four inserts is at least one inch, and the width plus the length of at least four inserts is equal to or slightly less than the interior wall horizontal dimensions of said container.

26- The insulated container of claim 24, wherein the space between the double side walls of each of two opposing sides of said container, and the rear double side walls is substantially uniform and are free of recesses, the frtnt side of said container has a shallow recess, and a temperature data display and said wireless transmitter for transmitting monitored temperature data unit is mounted in said shallow recess, said container has a flange region upwardly extending from each side wall and forming a "IT-shaped channel at the top of said contai .er, said container cover being positioned within said "IT -shaped channel, hand holds .ormed in each of said flange regions, said hand holds comprising openings in said flange regions and have a convex outwardly facing surface, said releasable hinge means comprising a cylindrical shaft member extending from opposite sides of said cover, and curved channels in each of said flange regions, said curved channels being open at the upper edge of said flange regions, and extending toward the rear edge of said flange regions and being closed at said rear edge, each cylindrical shaft member being mounted for rotary movement in said curved channel, and being removable from said curved recesses via the open upper edge of said curved recesses, a locking member for locking said cover to said container, when said cover member is snapped in place at the rear edges of said flange regions, whereby said locking member precludes the cover from being removed from said container and prevents rotation of said cover about said releasable hinge, the interior of said container has an interior ridge proximate the upper edge of the interior walls of said container, having a ridge forming a longitudinal channel to receive an interior lid member, and hold said lid member in place, said lid member being a double wall member filled with a eutectic mixture, said cover forming a rabbet joint with the open end of the walls of said insulated container, said cover upper side and said container bottom wall, have a mating recess and ridge, said recess and said ridge having asymmetrical configurations, whereby the cover of a first container mates with the bottom of another container in only one configuration, such that the front wall of said first container and the front wall of said another container, lie in the same plane, said lock member being a pair of channels in said cover aΛd in said container front wall, said channels being aligned to receive a locking device.

28- The method of claim 27, wherein said monitored temperature data is transmitted to a data receiver by a RF transmitter.

29- The method of claim 27, further comprising maintaining said temperature sensitive material a sub-ambient temperature by the enthalpy fusion of a frozen eutectic mixture within the walls of said container.

30- The method of claim 29, wherein said eutectic mixture is CaCb and water.

31- The method of claim 27, further comprising maintaining said temperature sensitive material at a stable temperature by means of a high heat capacity mixture within the walls of said container. >

32- The method of claim 27, further comprising maintaining said temperature sensitive material in a predetermined temperature range within said container by enclosing said temperature sensitive materi, i within a padded, filled, pouch member sealed in the manner of a quilt, said member being filled with a eutectic mixture.

33- The method of claim 27, further comprising maintaining said temperature sensitive material in a predetermined temperature range within said container by covering said temperature sensitive material with a padded, filled, blanket member sealed in the manner of a quilt, said member being filled with a eutectic mixture.

34- The method of claim 27, further comprising the step of wirelessly transmitting data in said temperature history database, to a remote data receiver.