Apparatus, systems, and methods for the storage, handling, and / or processing of blood and blood components.

Abstract

To store, treat and / or process blood and blood components, and provide novel apparatus, systems, and methods associated with such storing, treating and / or processing.SOLUTION: A blood container carries a two-dimensional barcode on an exterior surface of the container, where the barcode encodes at least a manufacturer's part number or catalogue number for the blood container.SELECTED DRAWING: Figure 1A

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority and benefit to U.S. Provisional Application No. 62 / 218,214, filed September 14, 2015, U.S. Provisional Application No. 62 / 218,234, filed September 14, 2015, and U.S. Provisional Application No. 62 / 218,242, filed September 14, 2015, which are hereby incorporated by reference herein.

[0002] This application generally relates to the storage, treatment, and / or processing of blood and blood components, and to novel devices, systems, and methods related to such storage, treatment, and / or processing.

Background Art

[0003] It is well known that through blood donation, a donor visits a blood center or a hospital, etc., and whole blood is collected from the donor using a manual collection procedure. In such a procedure, blood is typically collected simply by flowing from the donor under gravity and venous pressure into a collection container (e.g., a flexible pouch or bag). Various blood collection devices can be used to assist and facilitate the collection of blood or blood components.

[0004] The collection container in manual collection is often part of a larger, pre - assembled arrangement of tubes and containers, and may be called a satellite container used in further processing of the collected whole blood. More specifically, whole blood is typically first collected into what is called a primary collection container, which also contains an anticoagulant, such as, but not limited to, a solution of sodium citrate, phosphate, and glucose (CPD).

[0005] After the initial collection, it is common practice to transport the collected whole blood to another facility or location, sometimes called a "back lab," for further processing. This processing typically requires manually loading the primary collection container, associated tubing, and satellite containers into a centrifuge to separate the whole blood into concentrated red blood cells and platelet-rich plasma or platelet-poor plasma. The separated components are then transferred from the primary collection container to one or more satellite containers, where the red blood cells are combined with an additive solution or preservative solution pre-filled in one or more satellite containers. One such additive solution contains sodium chloride, mannitol, adenine, and dextrose, such as that marketed under the trade name ADSOL® by Fenwall, Inc., Lakesville, Illinois, USA. If desired, the blood components are again centrifuged after the above steps, for example, to separate platelets from plasma. As is evident from this description, this process is labor-intensive, time-consuming, and susceptible to human error.

[0006] Continuous efforts are being made to automate the devices and systems used in the post-collection processing of whole blood, and recently, the use of automated blood component separators in such post-collection processing has been proposed. While many blood separation devices and procedures use the principle of centrifugation, there is also another classification of devices that use relatively rotating surfaces, at least one of which supports a porous membrane.

[0007] Such systems include a membrane-covered spinner having an internal collection system located inside a stationary shell or housing. Alternatively, the inner surface of a stationary housing may be covered with a membrane, or both the spinner and housing may include a membrane to which are associated. For the purposes of this description, these are called membrane separators. In such membrane separators, blood is supplied into an annular space or gap between the spinner and the shell and moves along the longitudinal axis of the shell to the outlet region. Plasma passes through the membrane and exits through the outlet port, while the remaining blood cell components (red blood cells, platelets, and white blood cells) remain in the gap and exit the region between the spinner and the shell through the discharge port. Membrane separators have been found to offer superior plasma filtration rates, firstly, due to a unique flow pattern ("Taylor vortex") induced within the gap between the rotating membrane and the shell. The Taylor vortex helps to separate blood cells from deposition and contamination or clogging of the membrane. Detailed descriptions of membrane separators can be found in U.S. Patents 5,194,145, 4,776,964, 4,753,729, and 5,135,667, all of which are incorporated herein by reference.

[0008] While membrane separators are widely used for plasma collection, they have typically not been used for the collection of other blood components, particularly red blood cells. One example of a membrane separator used in the collection of separated red blood cells is described in International Publication WO2014 / 039086A1 of a PCT patent application, which is incorporated herein by whole reference. Furthermore, a system using such a membrane separator for post-collection processing of whole blood is described in U.S. Patent Application 14 / 677,319, filed April 2, 2015, which is incorporated herein by whole reference.

[0009] The subject matter disclosed herein provides further advancements in various aspects of apparatus, systems, and methods that may be used in whole blood collection and post-collection processing systems, but is not limited to such systems. Examples of prior art apparatus or methods can be found in U.S. Patent No. 9,038,823 and U.S. Publication Application No. US2012 / 0269679. [Overview of the project]

[0010] There are several aspects of the subject matter that may be embodied separately or together in the apparatus, systems, and methods described and / or claimed herein. These aspects may be used alone or in combination with other aspects of the subject matter described herein, and the combined description of these aspects is not intended to exclude the separate use of these aspects or the assertion of such aspects separately or in different combinations as stated in the claims attached herein or subsequently amended. For the purposes of this description and the claims, unless expressly indicated, “blood” is intended to include whole blood and blood components such as concentrated red blood cells, plasma, platelets, and white blood cells, with or without anticoagulants or additives. Furthermore, the terms “imaging unit,” “scanning unit,” “imaging,” “scanning,” “imaging unit / scanning unit,” and “scanning unit / imaging unit,” and their variations, are used selectively or interchangeably in this statement, unless expressly otherwise, to refer to devices and / or methods used by devices that optically view or read images such as barcodes, logos, labels, or portions of labels on blood containers, regardless of whether such information is in the form of data encoded in a barcode, the actual image itself, whether the information or data is reflected in such an image, or can be derived from such an image, or any combination thereof, for the purpose of retrieving or obtaining information, and are not intended to distinguish between them.

[0011] The following summary is generally intended to inform the reader of various potential aspects of this subject, and is non-limiting and non-exclusive with respect to each of these potential aspects or combinations thereof. Further aspects and features may be found here and / or in the detailed descriptions in the accompanying drawings.

[0012] Authentication / Imaging In one aspect, a method is provided for the automated authentication of blood component containers. This method comprises scanning a commercial logo carried on the wall of the container; detecting specific characteristics of the scanned logo and comparing such characteristics to established reference characteristics of the commercial logo of a genuine blood component container; and determining whether the scanned container is genuine based on the comparison between the determined characteristics and the established reference characteristics. This method is preferably performed automatically by a programmable control unit associated with a blood processing device. In the event that a non-genuine container is detected, an alarm may be generated and / or the operation of the processing device may be disabled.

[0013] In relevant contexts, a system may be provided comprising a disposable blood or blood component processing circuit and a durable blood processing device collaboratively associated with the processing circuit to control the flow through the processing circuit. The processing circuit includes a blood or blood component container having a commercial logo supported on the outer surface of the container. The processing device includes a scanning unit configured to optically scan the logo when the container is collaboratively associated with the device and a programmable control unit configured to receive signals from a scanning unit. The control unit is programmed to detect specific characteristics of the optically scanned logo, compare such characteristics to established reference characteristics of the commercial logo of a genuine blood component container, and determine whether the scanned container is genuine based on the comparison between the determined characteristics and the established reference characteristics. The scanning unit also acquires an image of the logo and stores it or sends it to a data storage device for future reference and / or record-keeping.

[0014] In yet another independent aspect, an apparatus for processing medical fluids such as blood or blood components is provided, the apparatus comprising a housing, a container suspension device for suspending a container on the apparatus, and a scanning system for scanning at least a portion of the surface of the container facing the suspension device when suspended above the suspension device. The scanning system comprises a window adjacent to the position of the container suspended from the suspension device within the housing, and a scanning unit positioned within the housing through the window to scan or image the surface of the suspended container. The scanning unit is positioned to image a selected surface area of ​​the container. The selected surface area may be a label carried on the container, which may include, but is not limited to, barcodes, commercial logos, and / or other information or images as summarized above.

[0015] Barcode / Labeling In one aspect, a blood container is provided having a two-dimensional barcode on its outer surface. The barcode may encode at least the manufacturer's part number or catalog number for a particular blood container. It may also contain other information, such as the expiration date of the blood container. The blood container is preferably suspended on a blood processing device, configured such that when suspended, the barcode is positioned on the blood processing device side of the container. This allows the barcode to be scanned by a scanner on the device in order to obtain the encoded information. The encoded information may include all the manufacturing-related information required by the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components regarding the blood or blood components to be contained in the container.

[0016] In a further context, a whole blood collection container is provided for collecting whole blood from a donor. The container comprises a wall having an outer surface, a first panel substantially permanently bonded to the outer surface of the container wall, and a second panel detachably bonded to the first panel, the second panel being detachable from the first panel for transfer and adhesion to the surface of another blood component container. The second panel has an outer surface carrying a plurality of detachable identification panels, each detachable for transfer and adhesion to a third container, each of the third panels carrying its own tracking identifier.

[0017] In another aspect, a blood container label is provided, comprising a first panel including first and second opposing surfaces, the first surface comprising an adhesive for attachment to a blood container. The label also includes a second panel detachably supported on the second surface of the first panel. The second panel supports a plurality of detachable identification panels, each including a first surface for attachment to a blood container and an opposing surface carrying its own provided identification number.

[0018] In a relevant context, a method for tracking blood or blood components is provided. The method includes a first panel substantially permanently adhered to the outer surface of a whole blood container for collecting whole blood from a donor, and a second panel smaller than the first panel and detachably adhered to the outer surface of the first panel. The second panel carries a plurality of detachable identification panels, each detachable for transfer to and adhesion to another container, and each identification panel carries its own tracking identifier.

[0019] Blood container / processing equipment and system In one aspect, a single blood collection container is provided, comprising a pair of opposing flexible plastic sheets sealed together along a sealing line that defines an internal space for receiving blood, the space having a first end and a second end, and a first side and a second side. An inlet port and an outlet port extend from the first end through the sealing line for flowing blood into and out of the container, and the sealing line is uninterrupted except at the inlet and outlet ports. An inlet tube connects to the inlet port and extends toward a distal end or a second end for connection to a vascular access member. An outlet tube has a first end connected to the outlet port and a second end sealed to maintain sterility for sterile connection by a sterile connection device to a blood processing set on a blood processing device. This single blood collection container can be used independently or in combination with any of the aspects summarized below, the following aspects can be used independently with other containers, systems, or methods.

[0020] According to another aspect of this subject, a blood collection container is provided comprising a pair of opposing flexible plastic sheets sealed together along a sealing line that defines an internal space for receiving blood, the space having a first end and a second end, and a first side and a second side. An inlet port and an outlet port extend through the sealing line in the first side or the second side for allowing blood to flow into or out of the container, with holes located in at least one of the first side and the second side.

[0021] In another aspect, an integrated container system may be provided comprising a pair of opposing flexible plastic sheets that are sealed together to define at least two separate internal spaces, one for receiving blood and the other filled with a pre-selected amount of red blood cell additive fluid. Each space is defined by a separate sealing line extending around it, and each space includes a first end and a second end, and a first side and a second side. The containers are integrally connected by a plastic web extending between the sides of the spaces. Blood space inlet ports and blood space outlet ports extend through the corresponding blood space sealing lines at the first end of the blood space to allow blood to flow into and out of the container, and the sealing lines are uninterrupted except at the inlet and outlet ports. Additive fluid space access ports and additive fluid space outlet ports extend through the additive fluid space sealing lines at the first end of the additive fluid space, and the sealing lines are uninterrupted except at the access and outlet ports.

[0022] In another aspect, a durable blood processing device is provided which is associated to cooperate with a disposable blood or blood component processing circuit, which includes a plurality of separate processing circuit modules for cooperative mounting on the processing device, one of which includes a rotatable blood separator, and the processing device includes a receiving station for the rotatable blood separator and a drive system for rotating the separator in the station. Each of at least two processing circuit modules includes a thermoplastic fluid flow tube element, and the processing device includes a sterile connector to receive the tube element and to automatically connect the tube elements in a sterile manner for the fluid flow through it when the user operates the device.

[0023] These and other aspects of this subject are described in the following detailed description and attached drawings. [Brief explanation of the drawing]

[0024] [Figure 1A]Perspective view of a blood treatment system comprising a reusable durable portion and a disposable fluid flow circuit formed from a plurality of fluid flow subsystems or modules.

[0025] [Figure 1B] Perspective view of the blood treatment system shown in FIG. 1 from another angle.

[0026] [Figure 2] Front view of a single whole blood collection container.

[0027] [Figure 3] Front view of an integrated whole blood collection container and additive solution container.

[0028] [Figure 4] Schematic diagram of a blood or blood component container labeling system and method of use thereof.

[0029] [Figure 5] Flow schematic diagram illustrating another blood or blood component container labeling system and method of use thereof.

[0030] [Figure 6] Flow schematic diagram illustrating a further blood or blood component container labeling system and method of use thereof.

[0031] [Figure 7] Schematic perspective view of a blood or blood component container having a two-dimensional barcode and a scanning portion for scanning the barcode.

[0032] [Figure 8] Schematic perspective view of a blood or blood component container having a commercial logo and a scanning portion for scanning the commercial logo.

[0033] [Figure 9]Figures 1A and 1B show schematic cross-sectional views of a medical fluid processing device, such as the blood processing device, indicating the location of the scanning unit of the processing device. [Modes for carrying out the invention]

[0034] Blood processing system Figure 1 illustrates a blood processing system, and in particular, the post-collection blood processing system, including a durable, reusable processing unit 12 and a disposable fluid flow circuit 14 for processing collected whole blood, is illustrated overall by reference numeral 10. The illustrated blood processing unit 12 includes associated pumps, valves, sensors, displays, and other instruments for configuring and controlling the flow of blood and additive solutions through the disposable circuit. The device and processing may be directed by an internal control unit including a programmable microprocessor that automatically controls the operation of the pumps, valves, sensors, etc.

[0035] More specifically, the illustrated processing apparatus includes a user input / output touch screen 16, a pump station including a whole blood pump 18, an RBC pump 20, and an additive solution pump 22, a blood separator mounting station and drive unit 24, a leukocyte filter housing 26, tube clamps / RF sealers / sensors 28a-d, sterile connection or docking devices 30a-b, tube clamps 32a-b, a hematocrit sensor 34, and a container scanning unit 36. The processing apparatus also includes lifting devices 38a-d, each associated with a weighing scale for lifting various containers of disposable fluid circuits.

[0036] As illustrated, the fluid flow circuit comprises three separate modules, each independently pre-assembled and coupled on the processing unit. These modules are: (i) an additive solution module comprising a pre-filled additive solution container 40 and an associated fluid flow tube 42 for drawing out the additive solution; (ii) a whole blood module comprising at least a whole blood container 44 and an associated fluid flow tube 46 for drawing out the collected whole blood from the container; and (iii) a processing module comprising a pump cassette 48, a membrane separator 50, a red blood cell (RBC) container 52, a plasma container 54, a leukocyte reduction filter 56 (located within the housing 26 as illustrated), and associated tubing. The pump cassette 48 delivers the fluid flow through three tubular loops extending from the cassette, each loop positioned independently to engage with a specific one of the pumps 18-22. The tubing may extend through the cassette, or the cassette may have pre-formed fluid flow channels that direct the fluid flow. As described above, the membrane separator comprises a membrane-covered rotor in a stationary housing, which is rotated by a magnetic drive unit associated with the mounting station 24, in order to separate plasma from the cellular components of whole blood.

[0037] The modules are independently positioned on the processing unit 12. For the whole blood module, the whole blood container 44 is suspended from a weighing scale hanger 38a on the front of the processing unit, and an associated fluid flow tube 46 extends from the lower end of the whole blood container, through a hematocrit sensor 34 and a tube clamp 32a, to a sterile connection device 30a, which is ultimately connected to a tube from the processing module.

[0038] With respect to the additive solution module, the additive solution container 40 is suspended from a weighing device 38b on the side of the processing unit, and an associated fluid flow tube 42 extends from the lower end of the additive solution container through an additive fluid tube clamp 32b to a sterile connection device 30b, which is ultimately connected to a tube from the processing module.

[0039] Moving towards the processing module, the membrane separator 50 is positioned in association with the separator mounting / drive station 24. The pump cassette 48 is mounted on the pump station PS adjacent to the pumps 18-22, through which the fluid flow is delivered for pump control, so that the tubular loop extending from the cassette is in a registered position, preferably in a position to automatically supply a specific one of the pumps 18-22. The whole vascular element 58 extends from the cassette to the sterile connection device 30b for automatic connection to a tube 46 associated with the whole blood container 44. The whole vascular element or its flow path continues through the cassette, forming an external tubular loop for cooperation with the whole blood pump 18, illustrated as a rotary peristaltic pump, and then from the cassette to the whole blood inlet 60 of the membrane separator 50.

[0040] The membrane separator separates whole blood into plasma and red blood cell concentrate (which may contain other cellular components such as platelets and white blood cells). The plasma is directed from the separator into a pre-mounted plasma container 54 suspended from a weighing sling 38c in front of the processing unit 12. To allow the plasma to flow from the membrane separator 50 into the plasma container, a tubular element 62 connects the plasma container to the plasma outlet 64 of the membrane separator and extends through a clamp / sealer / sensor 28a.

[0041] Concentrated red blood cells (RBCs) flow from the membrane separator 50, through the red blood cell discharge port 66 of the membrane separator, through the red blood cell fluid flow tube element 68, and to the pump cassette 48. The red blood cell tube element 68 follows the cassette and forms an external tube loop for cooperation with the red blood cell pump 20. From the cassette, the red blood cell tube element extends upward, past the leukocyte reduction filter 56, which removes leukocytes from the red blood cell concentrate. From the leukocyte reduction filter, the RBC tube element extends through the clamp / sealer / sensor 28b into the red blood cell storage container 52, which is suspended from a weighing scale hanger 38d on the side of the processing unit.

[0042] To help preserve the viability of red blood cells, an additive solution from the additive solution container 40 is added to the red blood cell container. Specifically, the additive solution flow tube 42 is connected by a sterile connection device 30b to an additive flow tube element 70, which is part of the processing module. The tube element 70 extends to a cassette 48, and the additive solution flows through an external loop that works in cooperation with the additive solution pump 22. Downstream of the pump 22, the additive solution flows into the RBC flow path (tube element 68 or a pre-formed flow path) in the cassette, where it mixes with the RBCs. The combined additive solution and RBCs then flow from the RBC tube element 68 into the filter 56 and container 52.

[0043] The tubular element 72 extends parallel to the RBC tubular element 68 overall, between the cassette 48 (which communicates with the RBC flow path) and the RBC storage container 52. This element is sealed at spaced intervals by a blood handler to provide a series of blood-filled “elements” that can be filled with blood from the container and subsequently cut for sampling, testing, and cross-matching.

[0044] The tubular element 72 also provides a path to allow for the removal of any remaining air from the RBC container after processing is complete. A pump may be used to pump the air from the RBC container through the tubular element 72 to an empty whole blood container and finally back to the whole blood container 44.

[0045] The tubular element 72 is an additional benefit. It can be used to flow RBCs directly into the RBC container 52, bypassing the filter 56. This is particularly useful when RBCs cannot be filtered for known physiological reasons, such as in donors suffering from sickle cell anemia. For these cases, the filter can be bypassed and the plasma can be processed and collected.

[0046] As described above, the disposable fluid circuit 14 is assembled from separate modules in the illustrated embodiment, and sterile connection (sometimes called sterile docking) devices 30a-b are provided for connecting fluid flow tubes of different modules. The sterile connection devices may employ several different operating principles. Known sterile connection devices and systems include, for example, a radiant energy system for melting opposing membranes of fluid flow tubes, as shown in U.S. Patent No. 4,157,723; a heated wafer system for cutting and thermal bonding or bundling tube elements together while melting or semi-melting the ends, as shown in U.S. Patent Nos. 4,753,697, 5,158,630, and 5,156,701; and a system for using a removable sealing film or web sealed to the ends of tube elements, as described in U.S. Patent Application Publication 2014 / 0077488. All of the above are incorporated in whole for reference.

[0047] More recently, systems for forming sterile connections using different techniques have been disclosed, in which sealed tubular elements are compressed or perforated, heated, and the sealed ends are cut. The tubing is then joined to similarly treated tubular elements. Detailed descriptions of this type of apparatus can be found in U.S. Patent Application Publication 2013 / 0153048 and U.S. Patent Application No. 14 / 309,305, filed June 19, 2014, both of which are incorporated herein in their entirety by reference. Other sterile connection devices based on other operating principles may also be used, but this is a type of sterile connection device that has been particularly well thought out for use as sterile connection devices 30a-b of the blood processing apparatus 12, as described above.

[0048] Furthermore, as shown in Figures 1A and 1B, the illustrated processing apparatus 12 includes a scanning unit 36 ​​associated with each container and facing it. Each scanning unit is configured to view or read barcodes and / or other information on the facing side (such as on the label) of a particular container, record them as part of the processing record, and send and receive images of barcodes, images of the whole or part of the label, and / or other information contained in or encoded in the information to and from the processing apparatus and / or a local or remote data management system for tracking and / or quality control purposes. Information may be exchanged by any suitable method, and the apparatus may be configured to send and receive information directly by wire connection, internet, LAN, WIFI, Bluetooth, or other suitable transmission and reception methods. As described below, an imaging unit also reads or images other information on the container or container label.

[0049] blood container Now, moving to a different, independent aspect of this subject, Figure 2 illustrates a single whole blood collection container and tube set or module. The container 80 is formed from a pair of opposing flexible plastic films or sheets 82, which may be made of any suitable heat-sealable material, but not limited to polyvinyl chloride. The container has an internal space having a first end 84, an opposite second end 86, a first side 88, and an opposite second side 90. The sheets are sealed together by radio frequency (RF) or heat sealing along a sealing line 92 that extends around the entire circumference of the container and is uninterrupted except at the inlet port 94 and outlet port 96 located at the first end of the container space. The positions of the ports may vary, but in the illustrated embodiment, the inlet port 94 is located between the outlet port and the second side 90 of the container, preferably substantially adjacent to the corner or joint between the first end and the second side. The outlet port 96 is illustrated as being located roughly midway between the first and second sides. Alternatively, it should be noted that ports 94 and 96 are either entry or exit ports, depending on their intended use.

[0050] The inlet port 94 is connected to an inlet flow pipe 98 extending to a pre-installed, needle-like vascular access device 100, or a standard Luer lock-like connector for connection to the needle. The inlet flow pipe 98 may have additional ports or connection sites as desired, such as for pre-serving sampling. It may also include an internal flangable valve 102, such as those disclosed in U.S. Patents 4,386,622, 4,181,140, ​​and 4,270,534, all incorporated as reference, which normally shields the flow through the pipe and can be opened by manual operation or by bending the pipe.

[0051] The outlet fluid flow tube 104 extends from the outlet port 96 to the sealed far end 106. Since the sterile connection device 30b is located on the processing device 12, the tube 104 is long enough to extend from the container 80 to the sterile connection device. The length may vary depending on the configuration of the device 12, but lengths of approximately 10–20 inches (25.4–50.8 cm), e.g., 13–14 inches (e.g., 13.5) or 17 inches (e.g., 33.0–35.6 inches (e.g., 34.3) or 43.18 cm) may be used in the configuration shown in the drawings to extend through the illustrated hematocrit sensor 34 and clamp 32a to the sterile connection device 30a. The use of an outlet tube separate from the inlet tube helps prevent the introduction of blood clots into downstream processing modules or systems if the user fails to transfer any blood remaining in the inlet tube into the container (also known as blood stripping) during collection.

[0052] The suspension holes are shown for illustrative purposes and are not limited to the slit 108, but are provided within the sealing line 92 for suspending the container from a weighing hook, such as those used in the processing apparatus 12. The slit 108 located at the second end 86 of the container 80 allows the container to be suspended vertically, while slits along the sides of the container allow it to be suspended in directions other than vertical, such as horizontally, or at a downward angle as shown in Figure 2, in which case the inlet port 94 is slightly lower than the outlet port 96 by a distance D. Suspension in this position helps to keep any solids, such as clots in the collected blood, away from the outlet port, preventing the outlet flow tube 104 from being blocked by such solids or introducing such solids into downstream processing system elements.

[0053] The number and position of the slits 108 can be changed. In Figure 2, two slits are shown on each side of the container along with a single end slit, but a single slit may also be used on one or both sides, and such slits may be positioned in the center or off-center. The end slit may be removed to allow only non-vertical suspension. Alternatively, the side slits may be omitted, and only a single end slit may be used for containers limited to vertical suspension. Providing multiple slits as shown in Figure 2 allows the user to select the desired suspension position.

[0054] Figure 3 shows an integrated container system 110 having two separate container spaces: an additive solution space in container 112 and a whole blood collection space in container 114. The spaces or containers are integrally connected by an intermediate web 116.

[0055] The integrated container is formed from two opposing flexible plastic sheets or films that are sealed together by RF or heat sealing. Each container is defined by a separate sealing line and has an overall rectangular shape with opposing ends and sides. The additive solution container or space 112 is formed by a sealing line 118 extending along the first end 120 and first side 122 and the second end 126 and second side 128. The sealing line is uninterrupted except for the outlet port 130 and access port 132 at the first end of the container. The access port allows the additive fluid to be added to the container 112 during manufacturing, and the outlet port 130 is attached to the length of a fluid flow tube 134 that is sealed at the far end for connection to a processing set or module, preferably a sterile connection.

[0056] The whole blood container or space 114 is formed by a sealing line 136 extending along a first end 138, a first side 140, a second end 142, and a second side 144. The sealing line is uninterrupted except for the outlet port 146 and inlet port 148 at the first end of the container. The inlet port allows the inflow of whole blood during collection, and the outlet port directs the fluid flow toward a downstream processing set or module. The inlet port also allows the addition of an anticoagulant solution into the container during production. An inlet flow tube 150 extends from the inlet port, and an outlet tube 152 extends from the outlet port. The inlet and outlet tubes 150, 152 may be configured similarly to the inlet flow tube 98 and outlet flow tube 104 described above in relation to the container in Figure 2.

[0057] The first side 122 of the additive solution container 112 is attached to the second side 144 of the blood container 114 by an integrated intermediate web 116, which is a portion of the original plastic sheet used in the formation of the container and extending between the containers. This web can be of any desired width and allows the containers to be folded into a more compact arrangement if desired for transport or handling.

[0058] Labeling / Tracking Figures 4–6 are directed to another independent aspect of this subject, systems and methods for identifying and tracking blood and blood components. Figure 4 is a flowchart illustrating the apparatus and process used in one embodiment. At the top of Figure 4 is an exemplary blood container 160, which may be a single container in the form of a bag or pouch, for example, as in Figure 2. A first panel or sticker 162 is pre-attached substantially permanently to the outer surface of the container. A second panel or sticker 164 may be smaller than the first panel and is pre-attached removablely to the outer surface of the first panel. The first panel has an outer edge or first panel periphery (defined by a side edge 1S and an end edge 1E), and since the second panel is smaller, the entire thing fits inside the first panel periphery. The surface of the first panel beneath the second panel may constitute a peel surface that allows for the removal of the second panel which is bonded on the back, or the second panel may have a peelable adhesive for removable attachment to the first panel.

[0059] As shown in the second step of Figure 4, a third panel or sticker 166 is permanently attached to the second panel by a technician or blood collector before the blood is actually collected in the container 160. The third panel includes several removable, uniquely coded Donation Identification Number (DIN) identification panels or stickers 168. These may be used to identify a particular donation and trace the source of blood components from that donation. The second panel has an outer or peripheral edge defined by a side edge 2S and an end edge 2E, and the third panel may be smaller than the second panel and may be sized to fit entirely inside the peripheral edge of the second panel. Similarly, the identification panel may be sized to fit inside the peripheral edge of the third panel (defined by a side edge 3S and an end edge 3E). In the next illustrated step, after blood collection, when the red blood cells are concentrated and transferred to another container 170, the second panel 164 (to which the third panel and a DIN panel such as a sticker are attached) is removed from the whole blood container and placed on the concentrated red blood cell container 170 and adhered. For subsequent blood type confirmation or other tests, the red blood cell sample may be removed from the red blood cell container and transferred to a sample container such as a test tube or vial 172, as illustrated as the final step in Figure 4. At this time, one of the DIN identification panels, such as a sticker, may be removed from the panel on the red blood cell container and permanently adhered to the sample container, thus maintaining traceability of the blood sample. The second panel may have a peelable surface that allows for the removal of the adhesive-attached DIN identification panel, or the DIN panel may have an adhesive that allows it to be peeled off from the third panel.

[0060] An alternative configuration and flow is illustrated in Figure 5. In this alternative, the whole blood container 160 does not have the first and second panels 162, 164 pre-attached to the container. Instead, the first and second panels are pre-attached separately for convenience, and the first panel is permanently adhered to the surface of the blood container prior to blood collection. In this case, the third panel 166, which has, for example, a DIN identification panel 168 sticker on it, is permanently attached to the second panel as described above, and the remaining steps are performed as described above, allowing traceability to be maintained.

[0061] A further alternative is shown in Figure 6. This is similar to Figure 5, except that the second panel itself is subdivided into multiple pre-printed and removable or peelable (e.g., from a release layer or by using a peelable adhesive) DIN identification panels or stickers for attachment to a sample test tube or vial. This eliminates the need for a third panel of separate DIN stickers permanently attached to the second panel.

[0062] Blood container with 2D barcode / authentication Now, moving on to another independent aspect of this subject, Figure 7 illustrates a particularly efficient configuration for the movement and recording of information. Shown here is an example of a common type of blood or blood component container 180, such as the single container shown in Figure 2 above. A two-dimensional barcode 182 is placed on the container and may contain information that can be scanned by a scanning unit 184, which is useful and important for tracking and quality control. Currently, the regulatory authorities concerned require that the information be placed in specific locations on the container. For some types of information, the information is required to be on different sides of the container or sufficiently far apart so that it cannot be read or scanned by a single imaging or scanning unit in a fixed position on the processing apparatus. One example of this is the manufacturer's part number or catalog number, which may be on the back of the container, and the product's expiration date, which may be on the right corner of the bottom front of the container.

[0063] Two-dimensional barcodes can store a much larger amount of information than one-dimensional or linear barcodes. In this aspect, preferably, a two-dimensional barcode containing relevant manufacturer data is used, located on the container or on the container label, facing a scanning unit 184 fixed on the processing unit, similar to the scanning unit 36 ​​shown in Figures 1A, 1B, or otherwise visible from the scanning unit 184. “Two-dimensional barcode” is not limited to any particular code format, specification, or standard, but is intended to be a general term and used in its usual sense to refer to a two-dimensional image or matrix that contains or codes information based on points or areas of light and dark within the matrix, where the matrix is ​​not exclusive but typically square or rectangular, in contrast to one-dimensional barcodes based on a series of lines and spaces. The information stored or coded may, but is not limited to, any manufacturer part number or catalog number of the container or module, lot number of the blood product to be contained in the product, expiration date, product code, and other such information, either alone or in any desired combination. Part numbers or catalog numbers are particularly beneficial to code, either alone or in combination with the product's expiration date. Optionally, barcodes may also include any additional manufacturer information required by the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components. While this does not preclude the required information from appearing elsewhere to comply with regulations, having this information coded within a single 2D barcode allows a single scanning device to automatically read / image all the information without user intervention, thus allowing the information to be retained as part of a stored processing record.

[0064] In another independent aspect of this application, Figure 8 schematically illustrates a blood container 190 having a commercial logo or mark 192 of a unique design or configuration associated with a specific source, which can be scanned by a scanning unit 194 to determine and certify whether the disposable product is authentic and claims to be so, and in this case is a product of a specific source (in this case, Fenwall, Incorporated). As used herein, “commercial logo” is intended to be general and may include any design and / or combination of numbers or letters, or a design that identifies a specific source of the product. A commercial logo may include, but is not limited to, a registered trademark.

[0065] More specifically, a processing device comprising such a system may include a programmable control processor, an onboard data storage device, and a search table of selected characteristics (or access to a remote data storage unit) of authentic containers, such as a commercial logo on an authentic Fenwall blood component container. Such characteristics may be one or more of a number of aspects and include, without limitation, one or more characteristics such as the positional coordinates of the logo on the container, the spacing between certain numbers and letters contained in the logo, the size of the font or image, the ratio of the size of certain aspects such as the ratio of different font sizes, the image density or ink density of a particular part of the logo, the image resolution of the logo, and the ink material of the logo. The detected characteristics of the container in question are compared with a reference identification of the logo of an authentic product stored therein, and based on the comparison, the control unit will determine whether the detected and stored characteristics are identical or sufficiently identical to determine that the product in question is authentic. If they are different, the control unit may generate an alarm or warning condition, such as an audible, visual, or other signal, and may even disable the operation of the processing device until an operator intervenes.

[0066] The scanning unit 194 of the present application may be separated from the barcode scanning unit described above, or, if practical, may be combined into a single scanning unit or scanning unit, such as the scanning unit 36 ​​on the processing device shown in Figures 1A and B. With respect to the two-dimensional barcode described above, the commercial logo 192 is preferably located on the surface of the container facing the processing device when the container is hung, or on the container label facing the processing device, so that the logo can be scanned automatically without any user intervention.

[0067] Figure 9 schematically shows the position of the scanning / imaging unit in a medical fluid processing apparatus, such as the blood processing apparatus 12 in Figures 1A-B. As partially shown here, the apparatus has a housing 200 with walls 202 and a hole in the walls forming a window 204. The window is located adjacent to the position from which a container 206, such as a blood or blood component container, an additive solution container, or other container, is suspended when it is suspended in the apparatus from a suspender 208 or other suspension member (e.g., a clamp). The window 204 preferably comprises glass that shields from electromagnetic interference. The scanning unit 210 is located behind the window 204 within the housing 200. A similar configuration is seen in Figures 1A-B, where the scanning unit 36 ​​is located on the apparatus opposite to the containers, behind each of the containers 40, 44, 52, 54.

[0068] The scanning unit 210 may be of any suitable design and may use any suitable scanning, imaging, or other technique for acquiring two-dimensional barcodes, logos, and / or blood container labels as described herein. For example, the scanning unit 210 may use a laser, camera, CCD scanning unit, or other suitable imaging or scanning device or technique. In one non-exclusive example, the imaging / scanning unit that may be used herein is the JE-227 scanning engine or similar device from JADAC Technologies, Inc., North Syracuse, New York.

[0069] As described above, the scanning unit 210 is preferably mounted inside the housing 200 for protection and is positioned to optically view or scan the container 206 through the window 204. The scanning unit is positioned to scan or image a specific surface area of ​​the container. More specifically, in relation to this subject, the scanning unit is preferably positioned to image a label 212 on the container surface facing the window, and the label has information to be recorded as part of the processing record. The information may be in the form of a barcode (e.g., the two-dimensional barcode mentioned earlier) or a code and / or commercial logo. In general, in the medical field, and especially in the field of blood collection and processing, the aspect ratio of the container and the label on the container are subject to the requirements of specific regulatory or standards-setting bodies. Typically, a label on a container for blood or blood components is rectangular and measures about 4 inches (102 mm) wide and about 4 inches (102 mm) long. The ISO 3826 standard indicates that a label on a blood component container measures 105 mm × 105 mm (4.1 inches × 4.1 inches). The labels may also need to comply with other standards such as ISBT-128 and ST-005, which require containers to support a base label measuring 100±2mm × 106±2mm (3.9 inches × 4.2 inches). Therefore, these labels are generally within a space of 4±0.25 inches × 4±0.25 inches. For the purposes of this description, the above labels can be said to be substantially 4 inches × 4 inches, even if they are slightly larger or smaller.

[0070] The scanning unit 210 in the illustrated embodiment is advantageously configured to image the entire or substantially the entire label 212, including, if present on the label, a barcode such as a two-dimensional barcode, for authentication purposes, for recording product information and a commercial logo. To achieve this, the scanning unit is specifically located within a housing. In the illustrated embodiment, the scanning unit 210 has a field of view 214 (having vertical and horizontal dimensions, but only the vertical direction is shown in Figure 9) and a focal length or focal length 216. To image a desired surface area of ​​a blood or blood component label having a label area of ​​approximately 4 inches × 4 inches, the scanning unit may have a vertical field of view of approximately 30–40 degrees and the same or larger horizontal field of view, and may be positioned approximately 6–8 inches (approximately 15–20 cm) from the surface of the suspended container. This configuration may be modified based on the size of the particular area to be imaged and the particular scanning unit used without departing from the present disclosure. As previously mentioned, one non-exclusive example of a scanning unit that may be used in this subject is the JE-227 scanning engine or similar device from JADAC Technologies, Inc. of North Syracuse, New York.

[0071] The inventions disclosed above can be summarized as follows:

[0072] (1) A method for automated authentication of a blood component container, comprising scanning a commercial logo on the wall of the container, detecting specific characteristics of the scanned commercial logo, comparing those characteristics with established reference characteristics of the commercial logo of a genuine blood component container, and determining whether the scanned container is genuine based on the comparison between the determined characteristics and the established reference characteristics.

[0073] (2) The method according to (1) above, wherein the detection of specific characteristics includes detecting at least one of the position coordinates of the logo on the container, the spacing between the letters of the logo, the font size, the ratio of different font sizes, the density of the logo ink, the material of the logo ink, and the resolution of the logo.

[0074] (3) The method described in (1) or (2) above, including storing and / or transmitting information from the scanned logo.

[0075] (4) The method of any one of (1) to (3) above, including generating a warning if the scanned container is not determined to be one that should be authenticated.

[0076] (5) Warnings include audible or visual signals, as described in (4) above.

[0077] (6) A system comprising a disposable blood or blood component processing circuit and a durable blood processing device cooperatively associated with the processing circuit to control the flow through the processing circuit, wherein the processing circuit includes a blood or blood component container having a commercial logo carried on the outer surface of the container, the processing device includes a scanning unit configured to scan the commercial logo when the container is cooperatively associated with the device, and a programmable control unit configured to receive signals from the scanning unit, wherein the control unit is configured to detect specific characteristics of the scanned logo, compare the characteristics to established reference characteristics of the commercial logo of an authentic blood component container, and determine whether the scanned container is authentic based on the comparison between the determined characteristics and the established reference characteristics.

[0078] (7) The system as described in (6) above, wherein the control unit generates an alarm and / or disables the operation of the processing unit when it is determined that the container is not genuine.

[0079] (8) The alarm system described in (7) above, including an audible or visual signal.

[0080] (9) The system according to (6) or (8) above, wherein the control unit detects and compares at least one of the position coordinates of the logo on the container, the spacing between the letters of the logo, the font size, the ratio of different font sizes, the density of the logo ink, the material of the logo ink, and the resolution of the logo.

[0081] (10) Apparatus for processing medical fluids such as blood or blood components, The processing apparatus includes a housing, a container suspension device for suspending a container on the processing apparatus, and a scanning system for scanning at least a portion of the surface of the container facing the suspension device when suspended therefrom, wherein the scanning system comprises a window located within the housing adjacent to the container when the container is suspended from the suspension device, and a scanning unit located within the housing to scan a selected surface of the suspended container through the window.

[0082] (11) The apparatus according to (10) above, wherein the scanning unit has a field of view and is located within the housing so as to be at a selected focal distance from the surface of the suspended container to be scanned, and the field of view includes substantially the entirety of a selected surface area.

[0083] (12) The apparatus according to (10) or (11) above, wherein the selected surface area is substantially the size of a label placed on the container.

[0084] (13) The apparatus according to any one of (10) to (12) above, wherein the window is made of glass that shields against electromagnetic interference.

[0085] (14) The apparatus according to any one of (10) to (13) above, wherein the selected area is rectangular in shape and substantially has a length and width corresponding to a container label required or proposed by a regulatory or standards-setting body for a suspended container.

[0086] (15) The apparatus according to any one of (10) to (14) above, wherein the selected area comprises a generally rectangular area substantially 4 inches long and 4 inches wide.

[0087] (16) The apparatus according to (14) above, wherein the rectangular area is substantially the size of a label required or proposed by ISO 3825 for a container of blood or blood components.

[0088] (17) The apparatus according to any one of (10) to (16) above, wherein the scanning unit is positioned so as to be located about 6 to 8 inches from the surface of the suspended container to be scanned.

[0089] (18) The apparatus described in (10) above, which is configured to store or transmit information scanned from a selected surface.

[0090] (19) The processing apparatus described in (18) above, which includes an image of a two-dimensional barcode and / or information encoded in a two-dimensional barcode.

[0091] (20) The apparatus described in (18) above, wherein the information includes an image of the selected surface.

[0092] (21) A blood container having a two-dimensional barcode on the outer surface of the container, wherein the barcode codes at least the part number or catalog number of the blood container manufacturer.

[0093] (22) The barcode codes the expiration date of the blood container, as described in (21) above.

[0094] (23) A blood container according to (21) or (22) above, configured to be suspended on a blood processing device, wherein the barcode is located on the side of the container facing the blood processing device when suspended on the blood processing device.

[0095] (24) A blood container as described in any one of (21) through (23) above, the barcode containing all information required by the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components regarding the blood or blood components to be contained in the container.

[0096] (25) A whole blood collection container for collecting whole blood from a donor, A whole blood collection container comprising a wall having an outer surface, a first panel substantially permanently bonded to the outer surface of the container wall, and a second panel detachably bonded to the first panel, the second panel being detachable from the first panel for transfer and bonding to the surface of a separate blood component container, the second panel having an outer surface carrying a plurality of detachable identification panels, each detachable for transfer and bonding to another container, each identification panel carrying its own tracking identifier.

[0097] (26) The whole blood collection container according to (25) above, wherein the identification panel is detachably supported on a third panel which is adhered to a second panel.

[0098] (27) The whole blood collection container according to (25) above, wherein the first panel includes a peelable surface to which the second panel is detachably bonded.

[0099] (28) The whole blood collection container according to (25) above, wherein the first panel has an outer periphery, and the second panel is smaller than the first panel so that the entire panel can be positioned inside the outer periphery of the first panel.

[0100] (29) The whole blood collection container according to (28) above, wherein the second panel has an outer periphery, and the third panel is smaller than the second panel so that the entire panel can be positioned inside the outer periphery of the second panel.

[0101] (30) The whole blood collection container described in (26) above, with a unique tracking number which is the provided identification number.

[0102] (31) A blood container label comprising a first panel including first and second opposing surfaces, the first surface including an adhesive for attachment to a blood container, and a second panel removably supported on the second surface of the first panel, the second panel supporting a plurality of removable identification panels, each including a first surface for attachment to a blood container and an opposing surface supporting a unique providing identification number.

[0103] (32) The blood container label according to (31) above, wherein the identification panel is removably supported on a third panel which is adhered to a second panel.

[0104] (33) The blood container according to (31) or (32) above, wherein the second surface of the first panel comprises a release layer to which the second panel is peelably adhered.

[0105] (34) A blood container label according to any one of (31) to (33) above, wherein the first panel has an outer rim, and the second panel is smaller than the first panel so that the whole can be placed inside the outer rim of the first panel.

[0106] (35) The blood container label according to (32) above, wherein the second panel has an outer rim, and the third panel is smaller than the second panel so that the entire panel can be positioned inside the outer rim of the second panel.

[0107] (36) A method for tracking blood or blood components, comprising: substantially permanently adhering a first panel to the outer surface of a whole blood container for collecting whole blood from a donor; and detachably adhering a second panel to the outer surface of the first panel, the second panel carrying a plurality of detachable identification panels, each detachable for transfer to and adhering to another container, each identification panel carrying its own tracking identifier.

[0108] (37) The method according to (36) above, wherein the first and second panels are attached to the whole blood container in advance, and the identification panel is attached to the second panel when whole blood is collected into the whole blood container.

[0109] (38) The method according to (36) or (37) above, wherein the first and second panels are pre-attached together and attached to the whole blood container approximately when whole blood is collected into the whole blood container.

[0110] (39) The method according to any one of (36) to (38) above, wherein the second panel is pre-cut to define a plurality of removable identification panels.

[0111] (40) The method according to (36) above, comprising collecting whole blood into a whole blood container, transferring blood components from the whole blood container to a second blood container, removing the second panel from the first panel, and adhering the second panel to the second blood container.

[0112] (41) The method according to (40), comprising transferring a sample of blood components from a second container to a sample container, removing the identification panel from the second panel, and adhering the identification panel to the sample container.

[0113] (42) The method according to (41) above, wherein the sample container is a test tube or vial.

[0114] (43) A single blood collection container comprising a pair of opposing flexible plastic sheets sealed together along a sealing line to define an internal space for receiving blood, the space having a first end, a second end, a first side, and a second side, and comprising an inlet port and an outlet port extending through the sealing line at the first end for allowing blood to flow from the container, the sealing line being uninterrupted except at the inlet port and the outlet port, and comprising an inlet tube having a first end connected to the inlet port and a second end connected to a vascular access member, and an outlet tube having a first end connected to the outlet port and a second sealing end for on-site sterile connection to a blood processing set by a sterile connection device.

[0115] (44) The single blood collection container according to (43) above, wherein the outlet port is located at the first end approximately midway between the first and second sides.

[0116] (45) A single blood collection container according to (43) or (44) above, comprising at least one hanging hole along a first or second side.

[0117] (46) A single blood collection container according to any one of (43) to (45), having at least two spaced-apart hanging holes along at least one of the first and second sides.

[0118] (47) A single blood collection container according to (45) or (46) above, wherein at least one hanging hole is located along a first side and an inlet port is located between the outlet tube and a second side.

[0119] (48) A blood collection container comprising a pair of opposing flexible plastic sheets sealed together along a sealing line to define an internal space for receiving blood, the space having a first end, a second end, a first side, and a second side, and comprising an inlet port and an outlet port extending through the sealing line at the first or second end for allowing blood to flow into and out of the container, and comprising a hanging hole located at least one of the first and second sides.

[0120] (49) The blood collection container according to (48) above, wherein the hanging hole is located on the first side and the inlet port is located closer to the second side than the outlet port.

[0121] (50) The blood collection container according to (48) or (49) above, comprising at least two hanging holes located on one of the first and second sides.

[0122] (51) An integrated container system comprising a pair of opposing flexible plastic sheets sealed together to define at least two separate internal spaces, one receiving blood and the other filled with a pre-selected amount of red blood cell additive fluid, each space defined by a separate sealing line extending around each space, each space including a first end, a second end, a first side, and a second side, the container being integrally connected by a plastic web extending between the sides of the spaces, and comprising a blood space inlet port and a blood space outlet port extending through the respective sealing lines at the first end of the blood space for allowing blood to flow from the container, the sealing lines being uninterrupted except at the inlet and outlet ports, and an additive solution space access port and an additive solution space outlet port extending through the respective sealing lines at the first end of the additive fluid space, the sealing lines being uninterrupted except at the access and outlet ports.

[0123] (52) The integrated container system according to (51), wherein the blood inlet tube includes a frangible closure that seals the blood inlet tube, the frangible closure being operable to open the inlet tube by external operation without exposing the inside of the tube to the ambient atmosphere, the blood space outlet tube having a first end connected to a blood space outlet port and a second sealing end for on-site sterile connection to a blood processing set by a sterile connection device, and the additive solution outlet tube having a first end connected to an additive fluid outlet port and a second sealing end for on-site sterile connection to a blood processing set by a sterile connection device.

[0124] (53) A durable blood processing device for cooperatively associating with a disposable blood or blood component processing circuit, comprising a plurality of separate processing circuit modules for cooperative mounting in the processing device, one of which comprises a rotatable blood separator, the processing device comprising a receiving station for the rotatable blood separator and a drive system for rotating the blood separator in the station, at least two of the processing circuit modules each comprising thermoplastic fluid flow tube elements, the processing device comprising a sterile connection device for receiving the tube elements for fluid to flow through when the user activates the device and for automatically connecting the tube elements to each other in a sterile manner.

[0125] (54) A durable blood processing apparatus as described in (53) above, wherein the sterile connection device cuts the sealed end of each tube element and melts the open ends of the tube elements together while maintaining sterility inside the tube.

[0126] While various independent and related aspects of the subject matter have been described with reference to the specifically illustrated structures and methods shown in the attached drawings, it is understood that the subject matter is not limited to such specific structures or methods and has applications to other forms and apparatus without departing from the scope of this disclosure. For this reason, reference to the following claims is required to ascertain the scope of the subject matter.

Claims

1. A blood processing device, A housing having a first surface and a second surface, wherein the first surface is defined in a substantially vertical plane and the second plane is defined in a different plane, A scanning system comprising a window incorporated into the housing and defined within the first surface of the housing, and a scanning unit disposed within the housing, wherein the scanning unit is configured to scan a two-dimensional barcode through the window, A touchscreen incorporated within the second surface of the housing, A container suspension device configured to suspend a blood container on the blood processing device, A tube clamp associated with the housing and configured to accommodate a tube connected to a suspended blood container, The housing comprises a control unit located inside the housing, The control unit is operatively connected to the scanning unit, the touchscreen, and the pipe clamp. A blood processing apparatus, wherein the control unit is programmed to perform a procedure in which blood is transported through the tube.

2. The blood processing apparatus according to claim 1, wherein the scanning system is configured to scan a selected surface area of ​​the blood container through the window.

3. The blood processing apparatus according to claim 1, wherein the scanning system is configured to scan a selected surface area of ​​a blood container suspended through the window.

4. The blood processing apparatus according to claim 3, wherein the scanning unit is positioned about 6 to 8 inches from the surface of the suspended blood container being scanned.

5. The blood processing apparatus according to claim 3, wherein the scanning unit has a field of view and is positioned within the housing so as to be at a selected focal distance from the surface of the suspended container being scanned, and the field of view substantially includes the entire selected surface region.

6. The blood processing apparatus according to any one of claims 2 to 5, wherein the selected surface area is substantially the size of a label placed on the blood container.

7. The blood processing apparatus according to any one of claims 2 to 5, wherein the selected surface area includes a substantially rectangular area with a length of 4 inches and a width of 4 inches.

8. The blood processing apparatus according to claim 1, wherein the window includes glass that shields against electromagnetic interference.

9. The blood processing apparatus according to claim 1, wherein the control unit is programmed to store or communicate information scanned from the two-dimensional barcode.

10. The blood processing apparatus according to claim 1, further comprising a weighing scale associated with the container suspension device and operatively connected to the control unit.

11. A system comprising a disposable blood processing circuit and a durable blood processing device cooperatively associated with the blood processing circuit to control the flow through the blood processing circuit, The blood processing circuit includes a blood container and a tube connected to the blood container. The aforementioned blood processing device is A housing having a first surface and a second surface, wherein the first surface is defined in a substantially vertical plane and the second plane is defined in a different plane, A scanning system comprising a window incorporated into the housing and defined within the first surface of the housing, and a scanning unit disposed within the housing, wherein the scanning unit is configured to scan a two-dimensional barcode through the window, A touchscreen incorporated within the second surface of the housing, A container suspension device configured to suspend a blood container on the blood processing device, A tube clamp associated with the housing and configured to accommodate the tube connected to the suspended blood container, The housing comprises a control unit located inside the housing, The control unit is operatively connected to the scanning unit, the touchscreen, and the pipe clamp. The control unit is programmed to perform a procedure in which blood is transported through the tube.

12. The system according to claim 11, wherein the scanning system is configured to scan a selected surface area of ​​a blood container through the window.

13. The system according to claim 11, wherein the scanning system is configured to scan a selected surface area of ​​a blood container suspended through the window.

14. The system according to claim 13, wherein the scanning unit is positioned about 6 to 8 inches from the surface of the suspended blood container being scanned.

15. The system according to claim 13, wherein the scanning unit has a field of view and is positioned within the housing so as to be at a selected focal distance from the surface of the suspended container being scanned, and the field of view substantially includes the entire selected surface region.

16. The system according to any one of claims 12 to 15, wherein the selected surface area is substantially the size of a label placed on the blood container.

17. The system according to any one of claims 12 to 15, wherein the selected surface area includes a substantially rectangular area with a length of 4 inches and a width of 4 inches.

18. The system according to claim 11, wherein the window includes glass that shields against electromagnetic interference.

19. The system according to claim 11, wherein the control unit is programmed to store or communicate information scanned from the two-dimensional barcode.

20. The system according to claim 11, further comprising a weighing scale associated with the container lifting device and operatively connected to the control unit.

Images