Positive image barcodes on flexible medical solution containers

Abstract

Printing a code on a flexible medical solution container includes providing a flexible medical solution container that is at least partially light-transmissive, storing a code including a number in a memory circuit, and converting the code including the number using a barcode symbology, the barcode symbology defining dark and light regions. The method also includes applying light-reflective ink to the container based on the barcode symbology, the light-reflective ink being applied in areas defined by the dark regions based on the barcode symbology, and light-absorbing ink being applied in areas defined by the light regions based on the barcode symbology. The applied light-reflective ink and light-absorbing ink result in a code representing the inversion of the dark and light regions defined in the barcode symbology.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 62 / 946,232, filed December 10, 2019, and U.S. Provisional Patent Application No. 62 / 971,345, filed February 7, 2020, which are incorporated herein by reference. [Background technology]

[0002] This application relates to printing codes onto substrates, and more particularly to printing bar codes onto flexible product containers, such as medical solution containers.

[0003] Medical solutions include a variety of solutions used in the medical field. Medical solutions include saline, sodium citrate, anticoagulants (such as sodium citrate, phosphate, and dextrose solutions), or other solutions. Medical solutions also include biological products such as urine and blood products such as plasma, whole blood, white blood cells, and platelets. Medical solutions also include various pharmaceuticals such as drugs. Medical solutions are packaged in flexible plastic containers for transport. Barcodes are used to track the inventory and usage of these medical solution containers. Medical solution containers are typically at least translucent, creating a substrate with specific characteristics that must be considered when printing barcodes.

[0004] In one method, an opaque coating with a reflective color is applied to the surface of a web of transparent material. The coating is applied in a barcode pattern, with non-reflective bars defined by uncoated strips of the web and reflective spaces between the bars defined by the opaque coating. Thus, instead of printing dark areas of the barcode, this method prints white areas of the barcode and relies on the transparent material to absorb the light in the dark areas of the barcode. [Brief explanation of the drawings]

[0005] The accompanying drawings illustrate various embodiments:

[0006] [Figure 1] FIG. 1 is a top view of a container of medical solution according to an exemplary embodiment.

[0007] [Figure 2] FIG. 10 is a top view of a container of medical solution according to a second exemplary embodiment.

[0008] [Figure 3] 1A-1C are diagrams of a QR code (left) and a QR code printed with retro-reflectivity (right), according to an exemplary embodiment.

[0009] [Figure 4] FIG. 1 is an illustration of a linear barcode in accordance with an exemplary embodiment.

[0010] [Figure 5] 1 is a flowchart illustrating a method for printing a code on a flexible medical solution container, according to an exemplary embodiment.

[0011] [Figure 6] 1 is a flowchart illustrating a method for printing a linear barcode on a flexible medical solution container, according to an exemplary embodiment.

[0012] [Figure 7] 1 is a flowchart illustrating a method for scanning a barcode from a container of a medical solution, according to an exemplary embodiment.

[0013] [Figure 8] 1 is a top perspective view of a container of medical solution having a barcode being scanned by a scanner according to an exemplary embodiment; [Figure 9] 1 is a top perspective view of a container of medical solution having a barcode being scanned by a scanner according to an exemplary embodiment;

[0014] [Figure 10] 1 is a cross-sectional view of a blood processing device scanning a container of medical solution according to an exemplary embodiment.

[0015] It will be understood that the various features of the embodiments disclosed herein represent novel structures, combinations, and elements as described and more particularly defined by the claims, and that variations in the disclosed embodiments of the invention are intended to be encompassed as falling within the scope of the claims. DETAILED DESCRIPTION OF THE INVENTION

[0016] In some embodiments, barcode symbols can be printed without requiring a two-color printing process.

[0017] In some embodiments, a white or light colored positive image is printed onto a plastic medical solution container in a single color or two color printing process.

[0018] In some embodiments, a white or light positive image and a black or dark negative image are printed onto the flexible plastic container.

[0019] In some embodiments, the barcode is printed on the clear solution container in compliance with Food and Drug Administration (FDA) regulations while minimizing manufacturing costs and the technical challenges associated with two-color printing processes.

[0020] In some embodiments, a positive image of light reflective ink is printed in the areas defined by the coding symbology to be dark areas, hi some embodiments, the light reflective ink is printed directly onto the plastic container, and the unprinted areas between the light reflective ink comprise dark areas associated with light areas by the coding symbology.

[0021] In another advantageous aspect, it may be easier to use a single color printing process to create barcodes that comply with quality standards than using a method in which two printing processes are aligned with each other on a substrate.

[0022] In some embodiments, the linear barcode may be generated to comply with the National Drug Code symbology and may further include at least 10 digits.

[0023] In various embodiments, the light reflective ink may be referred to as a positive barcode image printed on a substrate, where the light reflective ink positively represents dark areas defined by the symbology standard.

[0024] In some embodiments, the light and dark areas of the barcode are inverted relative to the symbology standard when printed on the flexible plastic pouch.

[0025] As an example of reflectance inversion, if the stored symbology defines a two-dimensional barcode having bright quiet zones surrounding a data zone, the computer may be configured to translate the code based on the symbology in which light-absorbing ink has been applied to the bright quiet zones.

[0026] According to various embodiments, the light-reflective ink may be white or other colors such as yellow selected to reflect more light than adjacent dark areas, and the light-absorbing ink may be black, brown, or other colors selected to absorb more light than adjacent light areas.

[0027] In some embodiments, one of the light-absorbing ink and the light-reflective ink can be printed first, with the other ink being printed in the spaces left between the areas printed with the first ink.

[0028] In one embodiment, a method of printing a code on a flexible medical solution container can include printing a linear barcode in white or light-reflective ink according to the National Drug Code (NDC) symbology, where the light-reflective ink is printed in areas identified as dark areas by the NDC symbology.

[0029] In one embodiment, the method may include printing a positive image of a linear or two-dimensional barcode in white ink or light-reflective material on a transparent container, such as a flexible plastic bag used to hold solutions for medical procedures.

[0030] In some embodiments, the barcode scanner may be configured to convert data in a data file representing a digital image of the barcode by inverting the data and converting the inverted data into a numeric code using a definition or symbology of the barcode in memory. For example, the processing circuitry may first receive the scanned image data and then invert or reverse pixels designated as light to designate them as dark, or vice versa. This inverted image data may then be processed according to the symbology stored in the memory circuitry to determine the numeric or alphanumeric data encoded by the barcode.

[0031] In some embodiments, the barcodes described herein may be generated according to a symbology that defines a mapping between a message or code and the barcode. The symbology specifications may include encoding the message into bars (dark areas) and spaces (light areas) and / or any of the following: start and / or stop markers, the size of the quiet zone required before and / or after the barcode, calculation of a checksum, and / or other specifications of the barcode.

[0032] In some embodiments, a two-dimensional barcode may be printed according to a QR code format. One aspect of the two-dimensional symbology may define a square quiet zone of a predetermined thickness around other elements of the QR code. The quiet zone is defined as a light area in the symbology. Another aspect of the symbology defines three distinctive squares at the corners of the QR code image and uses a smaller square near the fourth corner to normalize the image for the size, orientation, and viewing angle of the scanning camera. The squares include a dark, solid central square within a light-outlined rectangle of a first predetermined thickness within a dark-outlined square of a second predetermined thickness. Other aspects of the QR code symbology include error correction algorithms, encoding formats, encoding modes, etc., one or more of which may be reversed by the scanner before decoding according to the symbology.

[0033] In some embodiments, the barcode may be printed directly onto the surface of the substrate (no material between the printed ink and the flexible substrate), or the barcode may be printed onto a label that is applied to the flexible substrate.

[0034] FIG. 1 is a top view of a medical solution container according to an exemplary embodiment. The teachings herein can be applied to a variety of substrates, such as flexible or rigid substrates. The substrate may be transparent, light-transmitting, translucent, or opaque. The substrate may include or be manufactured using a plastic or polymeric substrate, such as polyvinyl chloride or other thermoplastic polymer, or a plasticizer-free material, such as a DEHP-free polymer. The substrate may be formed into a container configured to hold a fluid, which may be a medical fluid (e.g., blood products, medications, nutrients, saline, sodium citrate, additives, anticoagulants, etc.) or a non-medical fluid. Blood products may include red blood cell products, platelet products, plasma products, white blood cell products, etc. The fluid contained therein may itself be transparent, light-transmitting, translucent, or opaque. The liquid may be a bodily fluid other than blood, such as urine. The container may be manufactured with one or more ports for connecting to a tubing segment or lengths of tubing, spike ports, twist-off ports, luer connections, needles, other containers, additive pouches, and the like.

[0035] 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, such as, but not limited to, polyvinyl chloride. The container has an interior cavity with a first end 84, an opposite second end 86, a first side 88, and an opposite second side 90. The sheets are sealed together, such as by radio frequency (RF) or heat sealing, along a sealing line 92 that extends around the entire periphery of the container and is uninterrupted except for an inlet port 94 and an outlet port 96 located at the first end 84 of the container cavity. While the location of the ports may vary, in the illustrated embodiment, the inlet port 94 is between the outlet port and the second side 90 of the container, preferably substantially adjacent the corner or junction between the first end 84 and the second side 90. The outlet port 96 is illustrated as being approximately midway between the first and second sides. It should be noted that ports 94 and 96 may alternatively be either inlet or outlet ports depending on the intended use.

[0036] The inlet port 94 connects to an inlet tubing 98 that extends to a pre-attached venous access device 100, such as a needle, or to a connection, such as a standard luer lock, for connecting to a needle. The inlet tubing 98 can have additional ports or connection sites as needed, such as for pre-donation sampling. It may also include an internal frangible valve 102 that normally blocks flow through the tubing and can be opened by manual manipulation or bending the tubing.

[0037] A fluid outlet tube 104 extends from the outlet port 96 to a sealed distal end 106. The tube 104 has a length sufficient to extend from the container 80 to a sterile connection device disposed on an electromechanical blood processing device (not shown), such as an apheresis device, such as a plasmapheresis device. Exemplary blood processing devices can include the Amicus, Alyx, and Aurora centrifuge systems sold by Fenwall, Inc. of Lake Zurich, Illinois.

[0038] A hanging opening, shown as slit 108, is provided in sealing line 92 to allow the container to be hung from a hook, such as on a weighing scale used in a blood processing device. Slit 108 located at second end 86 of container 80 allows the container to be hung vertically, while slits along the side of the container allow the container to be hung in an orientation other than vertical, such as horizontally or at a downward angle as shown in FIG. 1 . Here, inlet port 94 is slightly lower than outlet port 96 by a distance D. Hanging in this position allows solids in the collected blood, such as blood clots, to settle away from the outlet port, helping to prevent such solids from clogging outflow tube 104 or introducing such solids into downstream processing system components.

[0039] 2 shows an integrated container system 110 having two separate container cavities: an additive solution cavity in container 112 and a whole blood collection cavity in container 114. The cavities or containers are joined together by an intermediate web 116. The additive solution may include saline, saline-adenine-glucose solution (SAGM), AS-3 solution containing citrate and phosphate, or other additive solutions.

[0040] The one-piece container is formed from two opposing flexible plastic sheets or films sealed together, such as by RF sealing or heat sealing. Each container is generally rectangular with opposing ends and sides defined by a separate sealing line. The additive solution container or cavity 112 is formed by a sealing line 118 extending along a first end 120, a first side 122, a second end 126, and a second side 128. The sealing line is uninterrupted except for an outlet port 130 and an access port 132 at the first end of the container. The access port allows additive fluid to be added to the container 112 during manufacturing, and the outlet port 130 is attached to a length of fluid flow tubing 134 sealed at its distal end for connection, preferably a sterile connection, to a processing set or module.

[0041] The whole blood container or cavity 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 an outlet port 146 and an inlet port 148 at the first end of the container. The inlet port 148 allows for the entry of whole blood during collection, while the outlet port directs fluid flow to a downstream processing set or module. The inlet port 148 also allows for the addition of anticoagulant solution to the container during manufacturing. An inlet tube 150 extends from the inlet port, and an outlet tube 152 extends from the outlet port. The inlet tube 150 and the outlet tube 152 can be configured similarly to the inlet tube 98 and the outlet tube 104 described above with respect to the container of FIG. 1.

[0042] The first side 122 of the additive solution container 112 is attached to the second side 144 of the blood container 114 by an integral intermediate web 116 that is part of the original plastic sheet used in forming the container and that extends between the containers. This web can have any desired width and allows the container to be folded into a more compact configuration if desired for shipping or handling.

[0043] As shown in FIG. 8, a container 180 or its flexible substrate may be printed with a barcode 182 used for tracking and inventory purposes. The barcode may be printed directly on the surface of the substrate (without any material between the printed ink and the flexible substrate) or on a label applied to the flexible substrate. The label may be transparent, light-transmitting, translucent, or opaque. The barcode may be a linear barcode, a two-dimensional barcode, or another barcode format. A linear or one-dimensional barcode is not limited to a particular code format, specification, or standard, but refers to a code containing lines and spaces of various widths that create a specific pattern. An example of a linear barcode is Code 128 of the international standard ISO / IEC 15417. A two-dimensional barcode is not limited to a particular code format, specification, or standard, but refers to a two-dimensional representation or matrix that contains or encodes information based on dark or light spots or regions (also called bars) within a matrix. This matrix is ​​typically, but is not limited to, a square or rectangular shape, as opposed to a one-dimensional barcode, which is based on a series of lines and spaces. The bars of a two-dimensional barcode may be dark or light-colored square pixels. A two-dimensional barcode containing appropriate manufacturer data can be used on the container or container label, preferably in a location facing or otherwise visible to the blood processing device's fixed scanner. The stored or encoded information may include, but is not limited to, the container or module's manufacturer's part number or catalog number, lot number, expiration date, product code of the blood product contained therein, and any other such information, alone or in any combination. Part numbers or catalog numbers may be particularly useful when encoded alone or in combination with product expiration dates. If desired, the barcode can include additional manufacturer information required or permitted by the U.S. Consensus Standard for the Harmonized Labeling of Blood and Blood Components. In one example, the two-dimensional barcode can conform to the GS1 Data Matrix symbology, which conforms to the ISO / IEC 16022 standard.

[0044] The barcodes described herein may be generated according to a symbology that defines the mapping between a message or code and the barcode. The symbology specifications may include the encoding of the message into bars (dark areas) and spaces (light areas), and / or any of the following: start and / or stop markers, the size of any quiet zones required before and / or after the barcode, the calculation of a checksum, and / or other specifications for the barcode.

[0045] In Figure 3, the image on the left is an image of a two-dimensional barcode in the form of a QR code, according to an exemplary embodiment. One aspect of the symbology defines a square quiet zone 302 of a predetermined thickness around other elements of the QR code. The quiet zone is defined as a bright area in the symbology. Another aspect of the symbology defines three distinctive squares 303a, 303b, and 303c at the corners of the QR code image, and a smaller square 303d near the fourth corner is used to normalize the image for the size, orientation, and field of view of the scanning camera. Each square 303a, 303b, and 303c includes a central dark solid square within a light outlined square of a first predetermined thickness within a dark outlined square of a second predetermined thickness. Other aspects of the QR code symbology may include error correction algorithms, encoding formats, encoding modes, etc.

[0046] Referring to Figure 4, a linear barcode according to an exemplary embodiment is shown. The symbology of the linear barcode defines left and right quiet zones 400 and 402, which are light areas of a predetermined minimum thickness, left and / or right leading indicators or guard bars 404, 406, a central bar pattern 408, a modulo check character 410, and a number of number system characters 412, 414. The barcode may be a UPC-A barcode. In one example, the leading indicator 404 includes a first dark area 420 followed (from left to right) by a first light area 422 followed by a second dark area 424.424 The regions may be elongated bars or lines, or other shaped regions. The leading indicator 404 provides an indication to the scanner that the next bar begins a series of bars that encode data.

[0047] The number system characters 412, 414 may comprise one or more alternating light or dark areas or bars of predetermined thicknesses to encode individual digits. For example, the number 1 may be represented by a light bar 2 units wide, a dark bar 2 units wide, a light bar 2 units wide, and a dark bar 1 unit wide. Thus, the barcode symbology may define the number 1 as 2-2-2-1. The symbology may define the number 2 as 2-1-2-2 (a light bar 2 units wide, a dark bar 1 unit wide, a light bar 2 units wide, and a dark bar 2 units wide). Each number system character 412 to the left of the central bar pattern 408 begins with a light bar (reading left to right), and each number system character 414 to the right of the central bar pattern 408 begins with a dark bar (reading left to right). Thus, the barcode symbology defines light and dark areas that encode different types of data using a predetermined mapping.

[0048] Referring to FIG. 5, a method for printing a code on a flexible medical solution container according to an exemplary embodiment is described. In block 500, a flexible medical solution container that is at least partially optically transparent is provided. The container may be manufactured as described herein or using other manufacturing techniques and provided to a printing station manually, via a conveyor, or by other methods. The printing station may include a hot stamp printer, a laser printer, an inkjet printer, a flexographic printer, a thermal printer, a thermal transfer printer, or other printing techniques. Under control of an integrated or separate computer, the printing station may be configured to store a code in a memory circuit (block 502) that includes numbers, alphanumeric characters, characters, symbols, or other data that is converted or translated into a printed barcode. In block 504, the computer's processing circuitry may be configured to convert the code or other data stored in the memory circuit into dark and light areas that are printed using a barcode symbology. The barcode symbology may be stored in the memory circuit (which may include one or more memories) in the form of data. As described herein, the symbology may define dark and light areas.

[0049] In block 506, the computer is configured to control the printing station to apply light-reflective ink to the container based on the barcode symbology, the light-reflective ink being applied to areas defined by the symbology to be dark regions. In block 508, the computer is configured to control the printing station to apply light-absorbing ink to the container based on the barcode symbology, the light-absorbing ink being applied to areas defined by the symbology to be light regions. These blocks 506 and 508 describe the inversion of the areas defined in the barcode symbology. For example, if the symbology defines a reading indicator with a first dark region followed by a first light region followed by a second dark region, in blocks 506 and 508 the computer is configured to control the printing station to print or apply light-reflective ink (to create the light regions according to the symbology) to the first and second dark regions and light-absorbing ink (to create the dark regions according to the symbology) to the first light region. The applied light-reflective and light-absorbing inks create a code that represents the inverse of the dark and light areas defined in the barcode symbology.

[0050] Light-absorbing ink may be fully opaque or partially opaque, such that some of the light that strikes the ink is absorbed and some is transmitted through the ink, hi some embodiments, objects can be seen through the light-absorbing ink.

[0051] In Figure 3, barcode 310 is an example of a two-dimensional barcode that can be printed according to the method of Figure 5 based on the QR Code symbology. As shown, square 312 is printed with light-reflective ink in the area defined by the QR Code symbology to be the dark central square (shown on the left as the interior portion of square 303c). Light-outlined square 314 is printed with light-reflective ink in the area defined by the QR Code symbology to be the dark-outlined square 316. In this way, barcode 310 is printed with inverted reflectance, printing light-reflective ink in locations defined by the symbology as having dark areas and light-absorbing ink in locations defined by the symbology as having light areas. In other words, the dark elements of the QR code are printed positively with light-reflective ink, providing a positive image of the QR code in light-reflective ink.

[0052] The reversal of dark and light ink for a symbology can be done for all elements of the printed code or for only some of the elements of the printed code.

[0053] In various embodiments, the light-absorbing ink may be printed before the light-reflective ink, which is then passed through a separate printer or printers. Alternatively, the light-reflective ink may be printed before the light-absorbing ink. Alternatively, dual printheads may be used to print both inks simultaneously. In some embodiments, one of the light-absorbing ink and the light-reflective ink may be printed first, and the other ink may be printed in the space left between the areas printed with the first ink. In another embodiment, a solid dark background may be printed directly onto the substrate first, and then the light-reflective elements may be printed on the dark background.

[0054] Referring to FIG. 6, a method for printing a linear barcode on a flexible medical solution container is described according to another embodiment. At block 600, a flexible medical solution container that is at least partially optically transparent is provided. In some embodiments, the container may be empty, while in other embodiments, the container may contain an additive solution to be added to the blood product. In still other embodiments, the container may be filled with the blood product and, optionally, the additive solution at the time of printing. At block 602, a code including a digit is stored in a memory circuit. The code can be entered via a user input device on a computer console using a memory stick or memory card, or loaded into the memory circuit from a network circuit from a remote computer using other methods or devices.

[0055] In block 604, the processing circuitry is configured to retrieve the code from memory and translate the code, including the digits, using a linear barcode symbology. The linear barcode symbology defines dark and light bars as shown in FIG. 4, although other linear or one-dimensional barcode symbology may be used in various embodiments. In block 606, the printer, under the control of the processing circuitry, is configured to print light-reflective ink or create light-reflective portions or areas in the areas defined as dark by the symbology. In this embodiment, applying dark reflective ink is not necessary because the container's own properties are designed to be sufficiently light-absorbing to provide the necessary contrast with the applied light-reflective portions. For example, printing light-colored ink, such as white or yellow ink, would cause the printed areas to substantially reflect light, while the areas left unprinted would be light-absorbing due to the selected container material, additives within the container, and / or blood product within the container.

[0056] In one advantageous aspect, only one printing step is required to form the barcode in the embodiment of Figure 6. The applied light reflective ink can provide a scannable linear barcode without printing a different color ink for the linear barcode.

[0057] In another alternative embodiment, a black label or solid background block can be printed to improve the light absorption properties of the substrate, and then a light reflective ink is printed on the black label (and therefore not printed directly on the substrate) to provide a reflectance-inverted positive image of the barcode.

[0058] One or more of the blocks, features, and / or characteristics of the method of FIG. 6 may be incorporated into or replace the blocks, features, and / or characteristics of the method of FIG. 5, and vice versa.

[0059] Referring to Figure 7, a method for scanning a code printed on a flexible medical solution container is described. The scanner can take a variety of forms: a handheld scanner, a smartphone or other mobile phone running a scanner application downloaded over a network, an apheresis machine that includes a built-in scanner (see, e.g., Figure 10), or others. The scanner may be configured to read a positive image printed in white ink on a clear plastic container for liquid products used in medical procedures such as blood donations and treatments.

[0060] At block 700, a flexible medical solution container is provided having a linear barcode printed thereon. The linear barcode may be a positive image of a barcode printed with light-reflective ink, a retroreflective barcode, a barcode printed or applied according to one or more of the processes described herein with reference to FIG. 5 and / or FIG. 6, or other barcode. At block 702, the container is illuminated with light from a light source. The light may include light in any of several spectral ranges, such as visible light, infrared light, ultraviolet light, etc. The light is at least partially reflected from the linear barcode printed on the container. The light may be absorbed and / or transmitted by the medical solution contained in the container and / or the flexible material of the container.

[0061] At block 704, a digital image of the barcode is acquired. The digital image may be acquired by a scanner or reader configured to acquire an image of a printed or painted barcode, decode the data contained in the barcode according to the barcode symbology, and transmit the data to a computer processing circuit. The scanner may include an integrated light source and other optical components, such as a lens, a light sensor, etc. The scanner may include a decoder circuit configured to analyze the barcode image data provided by the sensor. The scanner may include a pen-type reader that swipes a photodiode over the code, a laser scanner, a CCD or LED scanner, a camera-based reader, a video camera reader, an omnidirectional barcode scanner, a cell phone camera, a PDA, or an Auto-ID PDA scanner. The scanner may be a cordless or wireless scanner and may be configured to be held in a human hand or may be larger than handheld.

[0062] At blocks 706 and 708, the scanner's processing circuitry is configured to identify light-reflective or light bars in the scanned barcode as corresponding to dark bars in the barcode symbology standard. The processing circuitry is configured to identify light-absorbing or darker bars in the scanned barcode as corresponding to light bars in the barcode symbology standard. In one option, the processing circuitry may be configured to invert the dark and light areas of the symbology standard, store the inverted symbology standard in a memory circuit, and compare the scanned data to the inverted symbology standard. The imaging scanner may be configured to take a photograph of the barcode image, digitally process it, and compare the image to a known pattern.

[0063] A numeric code is generated by processing and / or decoder circuitry from the bar code standard and the identified light and dark bars in block 710. The code may be alphanumeric, numeric, or other form of data.

[0064] In various embodiments, the method of FIG. 7 may include filling the container with medical solution and / or emptying the container of medical solution before the illustrated block, after the illustrated block, or between any two of the illustrated blocks.

[0065] 8 and 9 show perspective views of a barcode scanner and the scanning of a barcode. FIG. 8 illustrates components of a barcode scanner according to an exemplary embodiment. Barcode scanner 800 includes a computer having a processing circuit 802, a memory circuit 804, a user interface 806, and an image sensor 808. Processing circuit 802 may include any analog and / or digital circuit components, such as a microprocessor, a microcontroller, an application-specific integrated circuit, programmable logic, an integrated circuit, and / or other electronic components configured to perform the processes and functions described herein. Memory circuit 804 is coupled to processing circuit 802 and may be programmed with operating software for scanner 800, which may include algorithms and / or programs for converting, decoding, inverting, etc., data from image sensor 804. The program may be stored in a tangible, non-transitory, computer-readable memory.

[0066] The image sensor 808 may take any of the forms described herein and may be configured to acquire a digital image of the barcode 182 from the flexible fluid container 180. The memory circuit 804 may be configured to store a barcode definition or symbology in the form of computer-readable instructions. The processing circuit 802 may be configured to identify light and dark bars in the digital image, convert the light bars to dark bars in the barcode definition, convert the dark bars to light bars in the barcode definition, and generate a numeric code based on the conversion that takes into account the barcode symbology. The user interface 806 may include a user input device such as a push button, a display including an LED, or a user output device such as a speaker, or a device that is both an input and output device, such as a touchscreen user interface. In response to user actuation of the input device, the processing circuit 802 may be configured to control the image sensor 808 to acquire an image of the barcode 182. The numeric code converted by the processing circuit 802 using the symbology and other processing in the memory circuit 804 may be displayed via the user interface 806 and / or transmitted to another computer for logging, further processing, reporting, etc.

[0067] In some embodiments, the user interface 806 may include a display configured to visually display at least one of a digital image of the barcode (which may be a positive image printed with light-reflective ink or a retro-reflectance image) and a numeric code.

[0068] The processing circuitry 802 may be configured to translate by inverting data in a data file representing a digital image and converting the inverted data into a numeric code using a barcode definition or symbology in memory. For example, the processing circuitry 802 may first receive scanned image data and then invert or reverse pixels designated as light to designate dark, and vice versa. This inverted image data may then be stored in memory and processed according to the symbology stored in the memory circuit to determine the numeric or alphanumeric data encoded by the barcode.

[0069] FIG. 10 illustrates an exemplary placement of a scanner / imaging device in a medical fluid processing device, such as a blood processing device. As shown in a partial view therein, the blood processing device (e.g., apheresis device, plasma exchange device, blood processing device, etc.) has a housing 200 having a wall 202 and an opening in the wall forming a window 204. The window is positioned adjacent to where a container 206, such as a blood or blood component container, additive solution container, or other container, will hang when suspended from a hanger 208 or other hanging member (e.g., a clamp) on the processing device. The window 204 can use glass shielded against electromagnetic interference. A scanner 210 can be positioned within the housing 200 behind the window 204.

[0070] The scanner 210 may be of any suitable design or use any suitable technology for scanning, imaging, or otherwise capturing two-dimensional barcodes, one-dimensional barcodes, and / or blood container labels, as described herein. For example, the scanner 210 may use a laser, camera, CCD scanner, or other suitable imaging or scanning device or technology. A non-limiting example of an imaging device / scanner that may be used herein is a Model E-227 scan engine or similar device from Jadak Technologies, Inc., having offices in North Syracuse, New York.

[0071] As mentioned above, scanner 210 is preferably mounted within housing 200 for protection and positioned to optically view or scan container 206 through window 204. The scanner is positioned to scan or image a specific surface area of ​​the container. More specifically, the scanner may be positioned to image label 212 on the surface of the container facing the window, the label bearing information to be recorded as part of the process record. The information may be in the form of or encoded with a barcode. In the medical field generally, and in the field of blood collection and processing specifically, aspects of the container and container label may be subject to specific requirements of regulatory or standard-setting bodies.

[0072] Advantageously, the scanner 210 in the illustrated embodiment can be configured to image the entire or substantially entire label 212, including the barcode, if one is present on the label for recording product information. To accomplish this, the scanner can be specifically positioned within a housing. In the illustrated embodiment, the scanner 210 has a field of view 214 (which can have vertical and horizontal aspects; only the vertical is shown in FIG. 10 ) and a focal length or distance 216. To image the desired surface area of ​​a solution container, a scanner with a vertical field of view of approximately 30-40 degrees and a horizontal field of view greater than this can be positioned approximately 6-8 inches (approximately 15-20 cm) from the surface of the suspended container. This configuration can vary based on the size of the particular area to be imaged and the particular scanner used without departing from this disclosure.

[0073] Example

[0074] A positive image of a GS1 Data Matrix barcode was printed in white (non-printed surface area) on a black background on paper. The code was scanned using a 2D barcode scanner attached to an Aurora 6R4601 plasmapheresis device. The data was successfully decoded using a Microscan verifier.

[0075] The arrangement of the illustrated embodiments is for illustrative purposes only. While only a few embodiments of the present disclosure have been described in detail, those skilled in the art who review this disclosure will readily appreciate that many modifications (e.g., changes in the size, dimensions, structure, shape, and proportions of various elements, parameter values, mounting arrangements, materials, colors, orientations, etc.) are possible without substantially departing from the novel teachings and advantages of the subject matter recited herein. Accordingly, all such modifications are intended to be included within the scope of the present disclosure as described herein. The sequential sequence of any manufacturing or method steps may be altered or re-sequenced in accordance with alternative embodiments. Other substitutions, modifications, changes, and / or omissions may be made in the design, operating conditions, and arrangements of the preferred and other exemplary embodiments without departing from the scope of the present disclosure as set forth herein. It should also be understood that modifications of the embodiments to the disclosed invention are intended to be included as falling within the scope of the claims.

Claims

1. providing a flexible fluid container for a medical solution that is at least partially optically transparent; storing a code including a numerical value in a memory circuit; converting said code containing numerical values ​​using a bar code symbology defining dark and light areas; applying light reflective ink to the container based on the bar code symbology, the light reflective ink being applied to areas defined by the dark areas; applying light absorbing ink to the container based on the bar code symbology, the absorbing ink being applied to areas defined by the bright areas; whereby the applied light reflective ink and light absorbing ink create a code that inverts the dark and light areas defined by the barcode symbology. A method for printing a code on a flexible medical solution container.

2. The method of claim 1 , wherein the light-reflective ink and the light-absorbing ink are applied directly to a surface of the flexible fluid enclosure.

3. The method of claim 1 further comprising manufacturing the flexible fluid container to include a port connected to a length of tubing.

4. 10. The method of claim 1, wherein the converting step further comprises converting the code into a linear bar code symbology having a reading indicator of a first dark area followed by a first light area followed by a second dark area, wherein the light reflective ink is applied to the first dark area and the second dark area, and the light absorbing ink is applied to the first light area.

5. 2. The method of claim 1, wherein the converting step further comprises converting the code into a two-dimensional bar code symbology having a bright quiet zone surrounding a data zone, and wherein the light-absorbing ink is applied to the bright quiet zone.

6. 6. The method of claim 5, wherein the code is converted into a GS1 Data Matrix symbology in a barcode structure.

7. providing a flexible fluid container for a medical solution that is at least partially optically transparent; storing a code including a numerical value in a memory circuit; converting said code containing numeric values ​​using a linear barcode symbology defining dark and light bars; applying light reflective ink to the container based on the linear bar code symbology, the light reflective ink being applied to areas defined by the dark bars; whereby the applied ink produces a linear barcode showing the dark and light bars defined by the linear barcode symbology in reverse. A method for printing a linear barcode on a flexible medical solution container.

8. The method of claim 7 further comprising manufacturing the flexible fluid container to include a port connected to a length of tubing.

9. 8. The method of claim 7, wherein the linear bar code symbology defines a start character including at least two dark bars surrounding a central light bar, and wherein the applying step further comprises applying the light reflective ink to the container to provide the at least two dark bars.

10. The method of claim 7 , wherein the applied light reflective ink provides a scannable linear barcode without printing a different color ink for the linear barcode.

11. The method of claim 7, wherein the container of medical solution is empty.

12. The method of claim 7 , wherein the linear barcode is a National Drug Code containing at least 10 digits.

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