The present invention relates to storage of blood and blood products, and more particularly to devices that provide active cooling of stored blood and blood products.
The United States Food and Drug Administration (“FDA”) determines storage requirements for all blood and blood products. Among other things, the FDA requires that blood and/or blood products be stored within a specific temperature range. For example, after 8 hours, whole blood must be stored between 1 and 6 degrees Celsius. During transport, the whole blood must be kept between 1 and 10 degrees Celsius. Additionally, the FDA requirements also state that, after collection, blood products may only be outside of the specified temperature range for prescribed (brief) period of time. If the temperature of the blood or blood products remains outside of the target temperature range for longer than the allowed time, the blood and blood products must be disposed of. As one may expect, loss and disposal of any blood or blood product is wasteful and costly.
Furthermore, the FDA guidelines become more of an issue when one considers that blood and blood products are not always collected and immediately processed or placed within a fixed storage device or location. In most instances, the blood and/or blood products must be transported to a different location for permanent processing, storage, and/or use.
Currently, hospitals and blood donation organizations transport collected/stored blood and blood products in a consumer-type cooler (e.g., similar to those used to store beverages and food) with ice packs, bags of ice, or dry ice, for example. This method provides only limited transport time and cannot ensure that the stored blood and blood products remain within the target temperature range (e.g., the temperature may be above or below the target range). Additionally, this method cannot ensure that all of the blood and/or blood products within the cooler are at the same temperature (e.g., some of the blood product containers may be within the temperature range and others may not because of the uneven cooling provided by ice packs). Lastly, this method is unable to provide any information regarding how long the blood product has been stored and for how long the blood product was outside of the target temperature range. Therefore, in many instances, if the ice pack melts during transport and there is uncertainty as to whether or not the blood went over the target temperature, the blood and/or blood products must be disposed of. In other instances, the temperature of the blood or blood products is sampled at the processing center. If the blood or blood product falls within the specified range, the blood or blood product is cleared for processing even though the blood or blood unit may have been outside of the specified range at any point since collection.
In a first embodiment of the invention, there is provided a portable biological-material storage device including an insulating housing, an inlet duct, and a return duct. The insulating housing may define the structure of the biological-material storage device and may have an interior cavity for storing biological material. The insulating housing may have an open top to allow access to the interior cavity. The inlet duct may be fluidly connectable to a conditioning device and may be located within the interior cavity of the storage device. The inlet duct may bring conditioned air into the storage device when fluidly connected to the conditioning device. The return duct may be fluidly connectable to the conditioning device and located within the interior of the storage device. The return duct may return exhaust air to the conditioning device when fluidly connected to the conditioning device.
In accordance with additional embodiments, there is provided a portable blood storage device including an outer housing and an inner housing. The outer housing defines the structure of the blood storage device. The inner housing may be located within the outer housing and may have an interior cavity for storing collected blood and/or blood products/components. The inner housing may also have an open top to allow access to the interior cavity.
The portable blood storage device may also have an inlet duct and an outlet duct within the interior cavity. Both the inlet duct and the outlet duct may be fluidly connectable to a cooling device. The inlet duct may bring conditioned air (e.g., warmed, cooled, or otherwise conditioned) into the storage device when fluidly connected to the cooling device. The return duct may return exhaust air to the cooling device when fluidly connected to the cooling device. The inlet and outlet ducts may have openings extending along the length of the ducts. The openings allow conditioned air within the inlet duct to enter the interior cavity and exhaust air within the interior cavity to enter the return duct.
In accordance with some embodiments of the present invention, the inner housing may be spaced from the outer housing to create a volume between the inner housing and the outer housing. The volume between the inner and outer housing may contain an insulator medium to help maintain the temperature within the storage device.
The portable blood storage device may also have a shroud located across the open top of the inner housing. The shroud may have a plurality of openings that extend through it and allow access to the interior cavity. Each of the plurality of openings may have a flap member(s) (or other flexible member) that prevents warm/ambient air from entering the interior cavity through the open top and prevents conditioned air within the interior cavity from exiting the interior cavity through the open top.
In accordance with further embodiments, the storage device may also have an inlet docking assembly and an outlet docking assembly. The inlet docking assembly may be located between the inlet duct and the cooling device, and may automatically create fluid communication between the inlet duct and the cooling device when the storage device is docked with the cooling device. The return docking assembly may be located between the return duct and the cooling device and may automatically create fluid communication between the return duct and the cooling device when the storage device is docked with the cooling device. When fluid communication is created, exhaust air may be returned to the cooling device, and conditioned air may be transferred from the cooling device to the inlet duct.
The inlet docking assembly may include a primary inlet door and a secondary inlet door. The primary inlet door may open as the storage device is docked with the cooling device. The primary inlet door may also open the secondary inlet door as it opens to create the fluid communication between the inlet duct and the cooling device The return docking assembly may include a primary return door and a secondary return door. The primary return door may open as the storage device is docked with the cooling device. The primary return door may also open the secondary return door as it opens to create fluid communication between the return duct and the cooling device. When the storage device is removed from the cooling device, the doors (e.g., the primary inlet door, the secondary inlet door, the primary return door, and the secondary return door) may automatically close to fluidly disconnect the inlet and return ducts from the cooling device.
In accordance with still further embodiments, the portable blood storage device may also include at least one temperature sensor located within the interior cavity. The temperature sensors may measure the temperature within the storage device at various locations. The storage device may also have an electrical connector in electrical communication with the temperature sensor and electrically couplable with the cooling device. The electrical connector may transfer blood storage device data to the cooling device.
In accordance with further embodiments, there is provided a portable cooling device for use with a blood storage device. The portable cooling device may have a cart chassis, a cart housing, a blood storage device support member, and at least one refrigeration unit. The cart chassis may define the structure of the portable cooling device and the cart housing may surround and enclose the chassis. The blood storage device support member may have a raised state and a lowered state. When in the lowered state, the support member may support a blood storage device. When in the raised state the support member may be substantially flush against the cart housing. The support member may also include a support leg that extends downward from the bottom surface of the support member and supports the support member against the floor. The portable cooling device may also have wheels or casters mounted to the chassis to allow the portable cooling device to be moved/transported.
The refrigeration unit(s) may be contained within the chassis and may be fluidly connected to the blood storage device when the blood storage device is supported by the support member and/or when the blood storage device is positioned on the cart and/or support member. The refrigeration unit may have a supply port and a return port. The supply port may be fluidly connected to an inlet duct on the blood storage device to allow conditioned air to be transferred to the blood storage device. The return port may be fluidly connected to a return duct on the blood storage device to allow exhaust air from the blood storage device to be returned to the portable cooling device.
The blood storage device support member may include a plate that may longitudinally slide within the support member to position the blood storage device to fluidly connect the supply and return ports with the inlet duct and return ducts. The plate may also have a first registration detail that corresponds to a second registration detail located on the blood storage device. The first and second registration details may orient the blood storage device on the plate.
Additional embodiments of the portable cooling device may also have a refrigeration chassis on which the refrigeration unit(s) may be mounted. The refrigeration chassis may be removable from the portable cooling device to allow for easy maintenance and/or replacement of components.
The portable cooling device may also have a cooling device electrical connector and a refrigeration control unit. The cooling device electrical connector may be in electrical communication with an electrical connector on the blood storage device when the blood storage device is fluidly connected to the refrigeration unit(s). The cooling device electrical connection may transmit data to and/or receive data from the blood storage device. The refrigeration control unit may be in communication with at least one refrigeration unit, and may control the operation of the refrigeration unit(s) based, at least in part upon, the data received by the cooling device electrical connector.
In accordance with additional embodiments, the portable cooling device may also include an embedded server for storing the data received by the cooling device electrical connection, and a wireless router or wireless access point device. The wireless router/access device may wirelessly transmit the data to and/or receive data from external devices. The portable cooling device may also have a battery back-up located within the chassis. The battery back-up may provide power to the refrigeration units, embedded server, wireless router and/or the wireless access point device if power is lost to the portable cooling device.
In accordance with still further embodiments, an active blood storage and cooling system is provided. The active blood storage and cooling system may include a portable cooling device and a blood storage device. The portable cooling device may have a refrigeration unit with a supply port and a return port. The blood storage device may have an interior cavity for storing blood products. The storage device may also have an inlet duct, and a return duct within the interior cavity. The blood storage device may be dockable with the portable cooling device. When docked, the supply port may fluidly connect to the inlet duct and the return port may fluidly connect to the return duct. The portable cooling device may send conditioned air to the blood storage device through the supply port and inlet duct and receive exhaust air through the return duct and return inlet.
The portable cooling device may include a blood storage device support member that may be oriented in a raised state or a lowered state. When in the lowered state, the support member may support the blood storage device. The support member may also include a plate that may longitudinally slide within the support member. The plate may position the blood storage device to fluidly connect the cooling and return ports with the inlet duct and return ducts on the blood storage device. The plate may have a first registration detail that corresponds to a second registration detail on the blood storage device. The registration details may orient and/or align the blood storage device on the plate.
In accordance with additional embodiments, the blood storage device may further include at least one temperature sensor within the interior cavity to measure the temperature within the blood storage device, and an electrical connector in electrical communication with the temperature sensor. The blood storage device may include a control module with a user interface that displays the blood storage device temperature and/or average temperature over time.
The portable cooling device may also have an electrical connector that is in electrical communication with the connector on the storage device when the blood storage device is docked with the portable cooling device. When connected, the storage device may transfer data to the portable cooling device. The portable cooling device may also include a control unit that controls the operation of the refrigeration unit(s) based, at least in part upon, the received data. The portable cooling device may store the data on an embedded server and/or wirelessly transmit the data to external devices using a wireless router/access device within (or external to) the cooling device.
In accordance with other embodiments, the storage device may have a wireless module that may send the blood storage data to an external device. The storage device may also include a location tracker (e.g., GPS) that tracks the location of the blood storage device during transport. The blood storage data may include the temperature within the blood storage device, a target temperature and/or range, a length of time that the stored blood components have been stored within the blood storage device, a length of time that the interior cavity has been above the target temperature, a quantity of blood product stored within the blood storage device, the type of blood product stored within the blood storage device, the location of the blood storage device, etc.
In accordance with additional embodiments, a portable storage device having an insulating housing, an inlet duct, and a return duct is provided. The insulating housing may define the structure of the blood storage device and may having an interior cavity for storing blood and blood components. The insulating housing may have an open top to allow access to the interior cavity. The inlet duct may be fluidly connectable to a cooling device and may be located within the interior cavity of the storage device. The inlet duct may bring conditioned air into the storage device when fluidly connected to the cooling device. The return duct may be fluidly connectable to the cooling device and located within the interior of the storage device. The return duct may return exhaust air to the cooling device when fluidly connected to the cooling device.
The foregoing features of the invention will be more readily understood by reference to the following detailed description, taken with reference to the accompanying drawings, in which:
In illustrative embodiments, a blood storage device may be used in conjunction with a portable cooling device to provide active cooling of the interior of the blood cooling device and, therefore, active cooling of stored blood and blood products. As discussed in greater detail below, embodiments of the present invention are able to maintain stored blood and blood products at the proper temperature and ensure that the blood and blood products are not stored above or below allowable temperature limits.
It is important to note that some embodiments of the present invention may also be used for storage and transportation of a variety of biological materials. For example, the storage device may be used to cool, store, and transport organs, tissues, cells, cellular material, and/or other biological material and tissue.
As described in greater detail below, the blood storage device 100 may also have a control module 720 (
As mentioned above, the blood storage device may be used in conjunction with a portable cooling device 200 to provide active cooling within the storage device 100.
The portable cooling device 200 may essentially have two states—a transport state (
It should be noted that, although the storage device body 110 is described above as having an inner housing 114 and an outer housing 112, other embodiments of the present invention may only have a single walled housing. For example, the storage device 100 may have a single insulating housing that helps maintain the temperature within the storage device 100.
As one may expect, the opening and closing of the blood storage device 100 (e.g., to insert and/or remove the blood or blood products) may allow the cold/conditioned air contained within the internal cavity 150 to escape and warm/ambient air to enter the storage device 100. To prevent this loss of cold/conditioned air, some embodiments of the present invention may have a shroud 160 beneath the lid 120 and covering the internal cavity 150. Therefore, when the lid 120 is opened to insert or remove the blood and/or blood products, the shroud 160 will keep the cold/conditioned air within the storage device 100 and prevent warm/room air from entering. The shroud 160 may rest on the ridge 107 of the body top 105.
In order to allow a user to insert and remove the blood and blood products from the internal cavity 150 of the storage device 100, the shroud 160 may have a series of passageways 162 extending through the shroud 160. The passageways 162 may contain a normally closed, cut membrane, a flexible member, or a series of normally closed flaps 164 that prevent the cold/conditioned air from escaping, but still allow a user to insert the blood and/or blood products into the storage device 100. For example, a user may push a blood bag through the passageway 162 causing the normally closed flaps 164 to open. Then, as the user removes their hand from the passageway 162, the flaps 164 will close, keeping the cold/conditioned air within the storage device 100.
As mentioned above, some embodiments of the present invention allow for active cooling within the storage device 100. To that end, the storage device 100 may include ductwork within the interior cavity 150. For example, the storage device 100 may include an inlet duct 170 and a return duct 175. As described in greater detail below, the inlet duct 170 may be used to transfer cold and/or conditioned air from the cooling device 200 into the interior cavity 150 of the storage device 100. Conversely, the return duct 175 may be used to transfer warm/exhaust air within the storage device 100 back to the cooling device 200 for cooling/conditioning and recirculation back to the storage device 100. The inlet duct 170 and the return duct 175 may have holes or slots 180 along the length of the ducts to allow cold/conditioned air to enter the internal cavity 150 from the inlet duct 170 and warm/exhaust air from the internal cavity 150 to enter the return duct 175. It should be understood that the term “warm air” as used herein refers to air that is warmer relative the cold/conditioned air that enters the storage device 100 and warmer relative to the target temperature range.
Also, because the slots 180 may be spaced along the length of the inlet duct 170, the slots 180 allow for even distribution of the cold/conditioned air within the internal cavity 150. For example, the inlet duct 170 may have a slot 180 located near each of the passageways 162. In this manner, each of the blood bags will essentially have their own slot 180 supplying cold/conditioned air. This may help prevent uneven cooling of the stored blood and blood products within the storage device 100. Additionally or alternatively, the slots 180 may be sized to allow even airflow and/or cooling within the storage device 100. For example, the slots 180 may be different sizes to assist with even air distribution along the inlet duct 170.
As shown in
The storage device 100 may also have a variety of components that aid in transportation and stacking of the storage devices 100. For example, the storage device 100 may have handles 118 located at either side of the storage device 100 that allow a user to easily lift and carry the storage device 100. Additionally, the lid 120 may be designed to allow multiple storage devices 100 to be stacked. For example, the lid 120 may have an indent 122 (or other physical feature or apparatus) sized to accommodate a protrusion 119 (or physical feature or apparatus) on the bottom of the storage device 100 (see
Additionally, to keep the blood and blood components secured within the storage device 100, the disposable sets 710 (e.g., the collection bags 711, 712, 713 in
In accordance with some embodiments, the lid 120 may also aid in securing the disposable sets in their respective passageway 162. For example, the underside 123 of the lid 120 may have protrusions 124 corresponding to each of the passageways 162 (see
In order to monitor the temperature within the storage device 100 and ensure that the temperature of the contents does not exceed allowable limits, the storage device 100 may have one or more temperature sensors 190 located within the internal cavity 150. The temperature sensor(s) 190 may monitor the temperature within the storage device 100 (e.g., at various locations) and transmit the temperature data to a variety of devices. For example, the temperature sensor(s) 190 may transmit the temperature data to the control module 720 so that it may be displayed on the user interface 140. Additionally or alternatively, the temperature sensor 190 may be connected to an electrical connector 195 which allows the storage device 100 to transmit the temperature data to external devices such as the cooling device 200. It is important to note that the electrical connector 195 may also be connected to the control module 720 and other sensors and measurement devices and may be used to transmit other data. For example, the electrical connector 195 may transmit information relating to the quantity and type of blood or blood products contained within the storage device (e.g., the information obtained by the RFID scanner mentioned below), the target temperature, the length of time that the blood/blood products have been within the storage device 100, if the temperature exceeded the target temperature and, if so, for how long, to name but a few. As discussed in greater detail below, the storage device may also wirelessly transmit and/or receive data.
In addition to transmitting data, the storage device 100 may also receive data from variety of external devices and/or the cooling device 200. For example, some embodiments of the present invention may have the thermostat/temperature controller located on the cooling device 200. In such embodiments, the storage device 100 may receive information regarding the set-point temperature and display it on the interface 140. Additionally or alternatively, if equipped with a wireless module (discussed in greater detail below) the storage device 100 may wirelessly receive data from handheld devices (e.g., data from handheld RFID scanners, PDAs, etc.).
As mentioned above and as described in greater detail below, various embodiments of the storage device 100 may be docked with the portable cooling device 200 so that the internal cavity 150 and the contents may be actively cooled using the inlet duct 170 and the outlet duct 175. To facilitate the connection of the ducts 170/175 to the ports 860A/B on the cooling device 200 (see
For example as shown in
The docking assembly housings 310A/310B may pass through openings within the panel mounts 320/330, the mounting plate 340 and the inner and outer housings 112/114. In some embodiments, the docking assembly housings 310A/310B may welded into the front panel mount 320. As best shown in
In order to allow the doors 352/357 of the primary door assemblies 350/355 and the doors 362/367 of the secondary door assemblies to open, the doors may be secured to the assemblies using bearing mounts 390,
It should be noted that the top primary door assembly 350 may correspond to the inlet duct 170 and the bottom primary door assembly 355 may correspond to the return duct 175. Likewise, the top secondary door assembly 360 may correspond to the inlet duct 170 and the bottom secondary door assembly 365 may correspond to the return duct 175. Therefore, when both the top primary door assembly 350 and the top secondary door assembly 360 are open, the inlet duct 170 is fluidly connected to the cooling device 200. Additionally, when both the bottom primary door assembly 355 and the bottom secondary door assembly 365 are open, the return duct 175 is fluidly connected to the cooling device 200.
As mentioned above, the docking assembly 300 may automatically open when the storage device 100 is docked with the cooling device 200. To that end, as the storage device 100 is docked with the cooling device 200, the doors 352/357 on the primary door assemblies 350/355 open (e.g., the evaporator ports 860A/B push the primary doors 352/357 open) exposing the openings 312A/312B within the assembly housings 310A/310B. As the primary doors 352/357 open further (e.g. as shown in
As mentioned above, the storage device 100 can have a controller 720 and a user interface 140 with a display 142. The controller 720 may also have memory that may be used to store time data, temperature data, as well as data regarding the amount and type of blood within the storage device 100. For example, each of the disposable sets 710 that are placed within the storage device may include an information tag that includes pertinent information regarding the disposable set and the type of blood/blood product that it contains. For example, the information tag may include the amount of blood/blood product, target storage temperature, the time that it was collected, the type of blood/blood product (e.g., whole blood, white blood cells, platelets, plasma, etc.), the location that the blood/blood product was collected, and the destination of the blood/blood product. The user may then read this tag and input the information into the control module memory using the user interface 140. Alternatively, the information tag may include a bar code and the information may be scanned in using a scanner (e.g., a bar code scanner), or the information tag may be an RFID tag and an RFID scanner may be used. In such embodiments, the scanner may be in communication with the storage device such that the information is automatically stored in memory. It is important to note that, by storing such information within the storage device 100, a data and temperature log may be created before, during and after transport that provides proof of compliance with regulatory requirements.
The controller 720 may also be used to set and/or adjust the target temperature within the storage device 100 if needed. When the storage device 100 docks with the cooling device 200, the controller 720 may send the storage and blood/blood product information to the cooling device 200 so that the cooling device 200 will begin active cooling at the appropriate temperature. Additionally, the controller 720 may display any of the information on the display 142 on the user interface 140.
As mentioned above, the storage device 100 may have a controller 720 that allows a user to set and/or adjust a target temperature. However, in some embodiments, the cooling device 200 may include a thermostat/temperature controller that allows a user to set and/or adjust the target temperature. In such embodiments, the user interface 140 and/or the controller 720 within the storage device 100 may only include monitoring, storage and display electronics (e.g., a user may not set or adjust the target temperature from the storage device 100).
As shown in
To help facilitate the airflow within the system, the refrigeration unit 820 may also have a fan 950 to send the cold/conditioned air within the evaporation chamber 942 to the inlet duct 170 within the storage container. In a similar manner, the refrigeration unit 820 may also have a return fan 960 that may aid in drawing the warm air (e.g., the exhaust air) within the storage device 100 into the return duct 175 and back to the evaporator 940. As the returning air enters the evaporator 940, the air may pass over a heater element 970. The heated air may then pass over the bottom portion of the evaporator coil 945 and remove any ice built up on the evaporator coil 945 (e.g., as a result of the evaporation). After passing over the bottom portion of the coil 945, the air may then be re-cooled and recirculated back to the storage device 100 using the fan 950 and inlet duct 170. The heater 970 and fans 925/950/960 may be controlled by a heater relay 1060 and fan relay 1070, respectively (see
Returning to
As mentioned above and as shown in
To aid in docking the storage device 100 with the cooling device, the support platform 240 may have a sliding plate 245 with a groove 247 that helps align the storage device 100 on the support platform 245. For example the protrusion 119 on the bottom of the storage device 100 may rest within the grove 247. Once the storage device is properly aligned on the support platform 200, the user may slide the sliding plate 245 towards the cooler device body 210 and complete the docking process.
As the storage device 100 is docked with the cooling device 200, the inlet duct 170 and return duct 175 may be fluidly connected with refrigeration units 820. To that end, the evaporator may have evaporator ports 860A/B (e.g., a supply port 860A and a return/exhaust port 860B) extending outward from the refrigeration unit 820. Therefore, as the storage device 100 is slid into place using the sliding plate 245, the evaporator ports 860A/B may open the primary door assemblies 350/355 which, in turn, will open the secondary door assemblies 360/365, as described above. Once the door assemblies are open, the inlet duct 170 and the return duct 175 are in fluid communication with the refrigeration units 820. The cooling device 200 may then send cold/conditioned air from the evaporator to the storage device 100 through the inlet duct 170 and receive warm and/or exhaust air through the return duct 175 for recirculation in the refrigeration unit 820.
In addition to making fluid connections between the refrigeration units 820 and the inlet and return ducts 170/175, docking the storage device 100 with the cooling device 200 may also automatically connect electrical connector 195 on the storage device 100 with a corresponding electrical connector 870 on the cooling device 200. Once the electrical connectors 195 and 870 are connected, the controller 720 within the storage device 100 may transfer the above mentioned data to the cooling device 200. The cooling device 200 may then begin cooling the storage device 100 based, at least in part, upon the data received from the storage device 100. In some embodiments, the cooling device 200 may provide the storage device 100 with power and/or recharge any power sources within the storage device 100 via the electrical connectors 195/870. It should be understood that any type of electrical connection that allows the transfer of information and power may be used. For example, the electrical connectors 195/870 may be standard PIN type connectors, USB connectors, etc.
Like the cooling device 200, the storage device 100 may also have a wireless module 1040 (e.g., a wireless access device, wireless access point device, wireless router, etc) and antenna 1045. The wireless module 1040 and antenna 1045 may be used to transmit storage device data to external devices. For example, the storage device 100 may transit the temperature data to a handheld device. Additionally, if the storage device 100 has a location tracker 1050 (e.g., a GPS), the storage device 100 may send the current location of the storage device 100 to an external device while the storage device 100 is in transmit. The wireless access device may provide wireless communication via IEEE 802.11 standard compatability networks, cellular data networks, and location information via GPS networks, for example.
It is important to note that, although the above described embodiments describe devices and systems utilizing cooling and refrigeration units/devices, other embodiments of the present invention may include other conditioning devices. For example, some embodiments of the present invention may have conditioning devices that warm, cool, humidify, and/or dehumidify the air that is sent to the storage device 100.
The embodiments of the invention described above are intended to be merely exemplary; numerous variations and modifications will be apparent to those skilled in the art. All such variations and modifications are intended to be within the scope of the present invention as defined in any appended claims.
This patent application claims priority from U.S. provisional patent application No. 61/178,004, filed May 13, 2009, entitled, “System and Method For Active Cooling of Stored Blood Products,” assigned attorney docket number 1611/A58, and naming Gary Stacey, Robert E. Putt, Michael R. D'Arrigo, Timothy Olaska, Steven Portela and Jay Black as inventors, the disclosure of which is incorporated herein, in its entirety, by reference.
Number | Date | Country | |
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61178004 | May 2009 | US |