HK40076256A - Positive image bar code on flexible medical solution container - Google Patents

Description

Positive image barcode on flexible medical solution container

Cross Reference to Related Applications

This application claims rights and priority from U.S. provisional patent application serial No. 62/946,232, filed on 12/10/2019, and U.S. provisional patent application serial No. 62/971,345, filed on 2/7/2020, the contents of which are incorporated herein by reference.

Background

The present application relates to printing a code on a substrate. The present application more particularly relates to printing bar codes on flexible product containers, such as medical solution containers.

Medical solutions include various liquid solutions used in the medical field. Medical solutions include saline, sodium citrate, anticoagulants such as sodium citrate, phosphate and glucose solutions, or other solutions. Medical solutions also include biological products, such as urine or blood products such as plasma, whole blood, leukocytes, platelets, and the like. Medical solutions also include various pharmaceutical agents, such as drugs. The medical solution is packaged in a flexible plastic container for shipping. Bar codes are used to track inventory and use of these medical solution containers. Medical solution containers are typically at least translucent, giving the substrate the specific characteristics that must be considered when printing a bar code thereon.

In one method, an opaque coating having a reflective color is applied to the surface of a web of transparent material. The coating is applied in a bar code pattern in which the non-reflective bars are defined by the uncoated bar-like regions of the web and in which the reflective spaces between the bars are defined by the opaque coating. Thus, the method does not print dark areas of the barcode, but rather prints white areas of the barcode and relies on a transparent material to absorb light for the dark areas of the barcode.

Drawings

The accompanying drawings illustrate various embodiments, and in which:

FIG. 1 is a top view of a medical solution container according to one illustrative embodiment;

FIG. 2 is a top view of a medical solution container according to a second illustrative embodiment;

FIG. 3 is a diagram of a QR code (left) and a QR code printed with inverted reflectivity (right) in accordance with an illustrative embodiment;

FIG. 4 is a diagram of a linear barcode in accordance with an illustrative embodiment;

FIG. 5 is a flow chart showing a method of printing a code on a flexible medical solution container in accordance with an illustrative embodiment;

fig. 6 is a flowchart illustrating a method of printing a linear barcode on a flexible medical solution container in accordance with an illustrative embodiment;

FIG. 7 is a flowchart illustrating a method of scanning a barcode from a medical solution container in accordance with an illustrative embodiment;

fig. 8 and 9 are top perspective views of a medical solution container with a bar code being scanned by a scanner in accordance with an illustrative embodiment; and

fig. 10 is a cross-sectional view of a blood processing apparatus scanning medical solution containers according to an illustrative embodiment.

The various features of the embodiments disclosed herein are presented in novel configurations, combinations, and elements as described and more particularly defined by the claims, it being understood that variations of the embodiments of the disclosed invention are intended to be included within the scope of the claims.

Detailed Description

In some embodiments, bar code symbols may be printed without the need for a two-color printing process.

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

In some embodiments, a white or light colored positive image and a black or dark colored negative image are printed on the flexible plastic container.

In some embodiments, the bar code is printed on a clear solution container that complies with Food and Drug Administration (FDA) regulations while minimizing production costs and minimizing technical challenges associated with a two-color printing process.

In some embodiments, the positive image is printed in light reflective ink in areas defined by the coding symbology as dark areas. In some embodiments, the light reflective inks are printed directly on the plastic container, and the unprinted areas between the light reflective inks include dark areas associated with light areas by the coding symbology.

In another advantageous aspect, it may be easier to form a bar code that meets quality standards using a monochrome printing process than using a method in which two printing steps are aligned with each other on a substrate.

In some embodiments, the linear bar Code may be generated to conform to a National Drug Code (National Drug Code) symbology, and the linear bar Code may further include at least ten digits.

In various embodiments, the light reflective ink can be considered a positive barcode image printed on a substrate, wherein the light reflective ink positively represents dark regions defined by a symbology standard.

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

As an example of reflectance inversion, where the stored symbology defines a two-dimensional barcode having light quiet zones surrounding data regions, the computer may be configured to convert the code based on the symbology such that light-absorbing ink is applied to the light quiet zones.

According to various embodiments, the light reflective ink may be white or other color, such as yellow, selected to reflect more light than adjacent dark regions. The light absorbing ink may be black, brown, or other color selected to absorb more light than adjacent light colored regions.

In some embodiments, one of the light absorbing ink and the light reflecting ink may be printed first, and the other of the inks may be printed within the spaces left between the areas printed with the first of the inks.

In one embodiment, a method of printing a code on a flexible medical solution container may include: the linear barcode is printed in white ink or light reflective ink according to the National Drug Code (NDC) symbology, wherein the light reflective ink is printed in an area identified by the NDC symbology as a dark area.

In one embodiment, the method may include printing a positive image of a linear barcode or a 2D barcode with white ink or light reflective material on a transparent container, such as a flexible plastic bag for containing a solution for a medical procedure.

In some embodiments, the barcode scanner may be configured to convert by inverting data representing a digital image of a barcode in a data file and converting the inverted data into a digital code using a barcode definition or symbology in memory. For example, the processing circuitry may first receive scanned image data and then invert or reverse any pixels indicated as light to indicate them as dark or to invert or reverse any pixels indicated as dark to indicate them as light. The inverted image data may then be processed according to a symbology stored in a memory circuit to determine digital or alphanumeric data encoded by the bar code.

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 specification of the symbology may include encoding the message into bars (dark areas) and spaces (light areas) and/or any one of the following: start and/or stop marks, the size of the quiet zone required before and/or after the bar code, the calculation of any checksums, and/or other specifications for bar codes.

In some embodiments, the 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 predetermined thickness surrounding other elements of the QR code. Quiet zones are defined in the symbology as light areas. Another aspect of the symbology defines three distinctive squares at the corners of the QR code image, with a smaller square near the fourth corner used to normalize the size of the image, the orientation of the scanning camera, and the viewing angle. The squares comprise dark solid central squares within light outline squares having a first predetermined thickness within dark outline squares having a second predetermined thickness. Other aspects of the QR code symbology may include error correction algorithms, encoding formats, encoding modes, etc., any one or more of which may be inverted by the scanner prior to decoding according to the symbology.

In some embodiments, the barcode may be printed directly to the surface of the substrate (without any material between the printed ink and the flexible substrate), or the barcode may be printed on a label that is applied to the flexible substrate.

Fig. 1 is a top view of a medical solution container according to an illustrative embodiment. The teachings herein can be applied to a variety of substrates, such as flexible substrates or rigid substrates. The substrate may be a transparent or translucent or opaque substrate. The substrate may comprise a plastic or polymeric substrate such as polyvinyl chloride or other thermoplastic polymer, or a plasticizer-free material such as a DEHP-free polymer, or may be manufactured using the above-mentioned 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 as a container configured to hold a fluid, which may be a medical fluid (e.g., a blood product, a medicament, a nutrient, saline, sodium citrate, an additive, an anticoagulant, etc.) or a non-medical fluid. Blood products may include red blood cell products, platelet products, plasma products, white blood cell products, and the like. The fluid contained in the container may itself be transparent or light-transmissive or translucent or opaque. The fluid may be a body fluid other than blood, such as urine. The container may be manufactured with one or more ports for coupling to a section of tubing or a section of tubing, a spike port, a twist-off port, a luer connector, a needle, other container, an additive bag, and the like.

The container 80 is formed from a pair of opposing flexible plastic films or sheets 82, and the pair of opposing flexible plastic films or sheets 82 may be made from 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 opposing second end 86, a first side 88, and an opposing second side 90. The sheets are sealed together, such as by Radio Frequency (RF) or heat seals, along a seal 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 at the first end 84 of the container cavity. The location of the ports may vary, but in the illustrated embodiment, the inlet port 94 is between the outlet port of the container and the second side 90, and preferably substantially adjacent to the corner or junction between the first end 84 and the second side 90. The outlet port 96 is shown approximately midway between the first and second sides. Alternatively, it should be noted that the ports 94 and 96 may be inlet or outlet ports, depending on the intended use.

The inlet port 94 is connected to an inlet flow tube 98, which inlet flow tube 98 extends to a pre-attached venous access device 100, such as a needle, or to a connector such as a standard luer lock to connect to a needle. The inlet flow tube 98 may have additional ports or connection locations as desired, for example, for pre-donation sampling, etc. The inlet flow tube 98 may also include an internal frangible valve 102, which internal frangible valve 102 normally blocks flow through the tube and may be opened by manual manipulation or bending of the tube.

An outlet fluid flow tube 104 extends from 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 located on an electro-mechanical blood processing device (not shown), such as a blood separation device, such as a plasmapheresis device. Exemplary blood processing devices may include Amicus, Alyx, and Aurora centrifuge systems sold by Fenwal corporation of zurich lake, illinois.

A hanger hole, shown as a slit 108, is provided in the seal line 92 to enable the container to be hung from a weigh scale hook used in, for example, a blood processing apparatus. Slits 108 in the second end 86 of the container 80 enable the container to hang vertically, and slits along the sides of the container enable the container to hang to suspend the container in a direction other than vertical, such as horizontally or at a downward angle, such as shown in fig. 1, where the inlet port 94 is slightly lower than the outlet port 96 by a distance D. Hanging in this position enables any solids, such as clots, in the collected blood to settle away from the outlet port and helps to avoid the outlet flow tube 104 from becoming clogged with such solids or introducing such solids into downstream processing system components.

FIG. 2 shows an integrated container system 110 having two separate container chambers-an additive solution chamber within container 112 and a whole blood collection chamber within container 114. The chambers or containers are integrally joined by an intermediate web 116. The additive solution may include a physiological saline solution, a saline-adenine-glucose Solution (SAGM), an AS-3 solution containing citrate and phosphate, or other additive solutions.

The unitary container is formed from two facing flexible plastic sheets or films that are sealed together, for example by radio frequency or heat sealing. Each container is defined by a separate sealing line and is generally rectangular in shape with opposed ends and sides. The additive solution container or cavity 112 is formed by a seal 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 the outlet port 130 and the inlet port 132 in the first end of the container. The inlet port enables additive fluid to be added to the container 112 during manufacture, and the outlet port 130 is attached to a segment of fluid flow tube 134 sealed at the distal end for connection to, preferably sterile connection to, a process kit or module.

The whole blood container or chamber 114 is formed by a seal line 136 extending along a first end 138, a first side 140, a second end 142, and a second side 144. The seal line is uninterrupted except for an outlet port 146 and an inlet port 148 in the first end of the container. The inlet port 148 enables the inflow of whole blood during collection and the outlet port directs fluid flow to a downstream process kit or module. Inlet port 148 also enables anticoagulant solution to be added to the container during manufacturing. An inlet flow 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 may be configured similarly to the inlet flow tube 98 and the outlet flow tube 104 previously described with respect to the vessel in fig. 1.

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 mesh 116, which integral intermediate mesh 116 is part of the original plastic sheet used to form the container and which extends between the containers. The web may have such a width as desired and enable the container to be folded into a more compact arrangement where transport or handling is desired.

As shown in fig. 8, a container 180 or flexible substrate thereof may be printed with a bar code 182 for tracking and inventory purposes. The barcode may be printed directly onto the surface of the substrate (without any material between the printed ink and the flexible substrate), or the barcode may be printed on a label that is applied to the flexible substrate. The label may be transparent or translucent or opaque. The barcode may be a linear barcode, a two-dimensional barcode, or a barcode in other barcode formats. A linear bar code or one-dimensional bar code is not limited to a specific code format, specification, or standard, but refers to a code including lines and spaces of various widths that produce a particular pattern. An example of a linear barcode is code 128 of international standard ISO/IEC 15417. A two-dimensional barcode is not limited to a particular code format, specification, or standard, but rather refers to a two-dimensional representation or matrix that contains or encodes information based on dark and light colored dots or areas (also referred to as bars) within the matrix, which is typically, but not limited to, a square or rectangle, and which contrasts with a one-dimensional barcode 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 bar code may be employed that contains the relevant manufacturer's data in a location on the container or container label that preferably faces or is otherwise visible from a stationary scanner on the blood processing apparatus. The stored or encoded information may include, but is not limited to, any of the manufacturer's part or catalog number, lot number, expiration date, product code for the blood product contained therein, and other such information for the container or module, alone or in any desired combination. Part or catalog numbers alone or in combination with product expiration dates may be particularly advantageous for encoding. Alternatively, the bar code may include any additional manufacturer information required or allowed by the united states consensus standard for uniform labeling of blood and blood components. In one example, the two-dimensional barcode may comply with the GS1 Datamatrix symbology that conforms to the ISO/IEC 16022 standard.

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

Referring to fig. 3, according to an exemplary embodiment, the image on the left side is an image of a two-dimensional barcode according to a QR code format. One aspect of the symbology defines a square quiet zone 302 having a predetermined thickness surrounding other elements of the QR code. Quiet zones are defined in the symbology as light areas. Another aspect of the symbology defines three distinctive squares 303a, 303b, 303c at the corners of the QR code image, with the smaller square 303d near the fourth corner being used to normalize the size of the image, the orientation of the scanning imaging device, and the viewing angle. Each square 303a, 303b and 303c comprises a dark solid central square within a light outline square having a first predetermined thickness within a dark outline square having a second predetermined thickness. Other aspects of the QR code symbol hierarchy may include error correction algorithms, coding formats, coding modes, and so forth.

Referring to FIG. 4, a linear barcode is shown in accordance with an illustrative embodiment. The symbology for the linear barcode defines: a left quiet zone 400 and a right quiet zone 402, which are light-colored areas having a predetermined minimum thickness; a left-hand leading indicator or guard bar 404 and/or a right-hand leading indicator or guard bar 406; a center bar pattern 408; a modulo check character 410 and a plurality of numeric system characters 412, 414. The barcode may be a UPC-A barcode. In one example, the leading indicator 404 can include a first dark region 420 followed (from left to right) by a first light region 422 followed by a second dark region 422. The regions may be elongate strips or lines, or regions of other shapes. The leading indicator 404 provides an indication to the scanner that the next strip will start a series of strips of encoded data.

The numeric system characters 412, 414 may provide one or more alternating light and dark areas or bars of predetermined thickness to encode the respective numeric bits. For example, the number 1 may be represented by a two-unit wide light bar, followed by two-unit wide dark bars, followed by two-unit wide light bars, followed by one-unit wide dark bar. Thus, the symbology used for the bar code may define the number 1 as 2-2-2-1. The symbology may define a number 2 as 2-1-2-2 (two single-bit wide light bars, followed by one single-bit wide dark bar, followed by two single-bit wide light bars, followed by two single-bit wide dark bars). The numeric system characters 412 located to the left of the center bar pattern 408 all start with light bars (read from left to right), while the numeric system characters 414 located to the right of the center bar pattern 408 all start with dark bars (read from left to right). Thus, the symbology used for barcodes defines light and dark areas that encode different types of data using a predetermined mapping.

Referring now to fig. 5, a method of printing a code on a flexible medical solution container in accordance with an illustrative embodiment will be described. At block 500, a flexible medical solution container that is at least partially light transmissive is provided. The container may be manufactured as described herein or using other manufacturing techniques, and may be provided to the printing station manually, via a conveyor, or by other methods. The printing station may include a thermoprinting printer, a laser printer, an inkjet printer, a flexographic printer, a thermal type printer, a thermal transfer printer, or other printing technology. Under the control of an integrated or separate computer, the printing station may be configured to store code in the memory circuit that includes numbers, alphanumeric characters, letters, symbols, or other data to be converted or translated into a barcode to be printed (block 502). At block 504, the processing circuitry of the computer may be configured to convert code or other data stored in the memory circuitry into dark and light regions to be printed using the bar code symbology. The bar code symbology may be stored in a data format in a memory circuit (which may include one or more memories). As discussed herein, a symbology may define dark and light regions.

At block 506, the computer is configured to control the printing station to apply light reflective ink to the container based on the bar code symbology, wherein the light reflective ink is applied in areas defined by the symbology as dark regions. At block 508, the computer is configured to control the printing station to apply light-absorbing ink to the container based on the bar code symbology, wherein the light-absorbing ink is applied in areas defined by the symbology as light areas. These blocks 506 and 508 depict the reversal of the defined area in the bar code symbology. For example, where the symbology defines a leading indicator having a first dark region, followed by a first light region, followed by a second dark region, at blocks 506, 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 dark region and the second dark region and light absorptive ink (to create the dark regions according to the symbology) to the first light region. The applied light reflecting ink and light absorbing ink produce a code representing the inverse of the dark and light areas defined in the bar code symbology.

The light absorbing ink may be completely opaque or partially opaque such that a portion of the light illuminating the ink is absorbed and a portion is transmitted through the ink. In some embodiments, objects may still be visible through the light absorbing ink.

Referring now to fig. 3, a barcode 310 is an example of a two-dimensional barcode that may be printed based on a QR code symbology according to the method of fig. 5. As shown, the square 312 is printed in light reflective ink at the area defined by the QR code symbology as the dark center square (shown at the left, inside of square 303 c). The light outline square 314 is printed in light reflective ink at an area 316 defined by the QR code symbology as a dark outline square. Thus, the bar code 310 is printed with a reflectance reversal that prints light reflecting ink at locations defined by the symbology as having dark areas and light absorbing ink at locations defined by the symbology as having light areas. In other words, the dark elements of the QR code are positively printed with the light-reflecting ink to provide a positive image of the QR code with the light-reflecting ink.

The inversion of the dark and light inks relative to the symbology may be done with respect to all of the elements of the printed code or may be done with respect to only some of the elements of the printed code.

In various embodiments, the light absorbing ink may be printed before the light reflecting ink passes through the printer or printers individually. Alternatively, the light reflecting ink may be printed before the light absorbing ink. Alternatively, two inks may be printed simultaneously using a dual print head. In some embodiments, one of the light absorbing ink and the light reflecting ink may be printed first, and the other of the inks may be printed within the spaces left between the areas printed with the first of the inks. In another embodiment, a pure dark background may first be printed directly on the substrate, and then the light reflective elements may be printed onto the dark background.

Referring now to fig. 6, a method of printing a linear bar code on a flexible medical solution container according to an alternative embodiment will be described. At block 600, a flexible medical solution container that is at least partially light transmissive is provided. In some embodiments the container may be empty, and in alternative embodiments the container may include an additive solution to be added to the blood product. In yet another embodiment, the container may be filled with the blood product and optionally with the additive solution when printed. At block 602, a code comprising a number is stored in a memory circuit. The code may be loaded into the memory circuit from a network circuit from a remote computer, using a memory stick or memory card, entered via a user input device of a computer console, or using other methods or means.

At block 604, the processing circuitry is configured to retrieve the code from the memory and convert the code, including the number, using a linear bar code symbology, such as that illustrated in fig. 4, which defines dark and light lines, although any other linear bar code or one-dimensional bar code symbology may be used in various embodiments. At block 606, the printer is configured to print light reflective ink or otherwise create light reflective portions or areas in the areas defined by the symbology as dark areas under control of the processing circuitry. In this embodiment, the dark reflective ink need not be applied, as the properties of the container itself are designed to be sufficient to absorb light to provide the necessary contrast with respect to the light reflective portion applied. For example, printing a light ink, such as a white ink or a yellow ink, will cause the so-printed areas to substantially reflect light, while the remaining unprinted areas will absorb light through the selected container material, additives within the container, and/or blood products within the container.

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

In another alternative embodiment, a black label or solid background patch may be printed to improve the light absorbing qualities of the substrate, after which a light reflective ink is printed on the black label (and thus not directly on the substrate) to provide a bar code positive image with reflectance reversal.

One or more of the blocks, features and/or characteristics of the method of fig. 6 may be incorporated into or replace a block, feature and/or characteristic of the method of fig. 5, whereas one or more of the blocks, features and/or characteristics of the method of fig. 5 may be incorporated into or replace a block, feature and/or characteristic of the method of fig. 6.

Referring now to fig. 7, a method of scanning a code printed on a flexible medical solution container will be described. The scanner may take various forms, such as a handheld scanner, a smartphone or other mobile phone running a scanner application downloaded over a network, a blood separation device including a built-in scanner (see, e.g., fig. 10), or other forms. The scanner may be configured to read a positive image printed in white ink on a transparent plastic container for liquid products used in medical procedures such as blood donation (donation), therapy, and the like.

At block 700, a flexible medical solution container having a linear bar code printed thereon is provided. The linear barcode may be a positive image of a barcode printed in light reflective ink, a reverse reflectance barcode, a barcode printed or applied according to one or more of the steps described herein with reference to fig. 5 and/or 6, or other barcode. At block 702, a container is illuminated with light from a light source. The light may include light in any of a number of spectral ranges, such as visible light, infrared light, ultraviolet light, and the like. The light is at least partially reflected by the linear bar code 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.

At block 704, a digital image of the barcode is acquired. The digital image may be acquired by a scanner or reader configured to: the image of the printed or painted bar code is captured, the data contained in the bar code is decoded according to the bar code symbology, and the data is sent to the processing circuitry of the computer. The scanner may have an integrated light source and other optical components such as lenses, light sensors, 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 reader, laser scanner, CCD or LED scanner, camera-based reader, video camera reader, omni-directional barcode scanner, cellular telephone camera, PDA or auto ID PDA scanner in which a photodiode slides across a code, and which may be a cordless scanner or a wireless scanner, and may be configured to be held in a person's hand or may be larger than hand-held size.

At blocks 706 and 708, the processing circuitry of the scanner is configured to identify light reflective bars or lighter colored bars of the scanned bar code as dark bars corresponding to bar code symbology standards. The processing circuitry is configured to identify light absorbing bars or darker bars of the scanned bar code as corresponding to light bars of a bar code symbology standard. In one option, the processing circuit may be configured to invert the dark and light regions of the symbology standard and store the inverted symbology standard in the memory circuit, and then compare the scanned data to the inverted symbology standard. The imaging scanner may be configured to take a picture of the barcode image, digitally process it, and compare the image to a known pattern.

At block 710, a digital code is generated by the processing circuit and/or decoder circuit from the barcode standard and the identified light and dark bars. The code may be alphanumeric, numeric, or other forms of data.

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

Referring now to fig. 8 and 9, there are shown perspective views of a barcode scanner and scanning of a barcode. FIG. 8 illustrates components of a barcode scanner according to an exemplary embodiment. The barcode scanner 800 comprises a computer having processing circuitry 802, memory circuitry 804, a user interface 806, and an image sensor 808. The processing circuit 802 may include any analog and/or digital circuit components, such as microprocessors, microcontrollers, application specific integrated circuits, programmable logic, integrated circuits, and/or other electronic components configured to perform the steps and functions described herein. The memory circuit 804 is coupled to the processing circuit 802 and may be programmed with operating software for the scanner 800, which may include algorithms and/or programs for converting, decoding, inverting, etc., data from the image sensor 804. The program may be stored on a tangible, non-transitory computer readable memory.

The image sensor 808 may take any of the forms described herein and may be configured to capture a digital image of the barcode 182 from the flexible fluid container 180. The memory circuit 804 may be configured to store bar code definitions or symbologies in the form of computer-readable instructions. The processing circuit 802 may be configured to identify lighter and darker bars of a digital image, convert the lighter bars to dark bars defined by a barcode and the darker bars to light bars defined by a barcode, and generate a digital code from the barcode symbology-based conversion. The user interface 806 may include a user input device such as a button, a user output device such as a speaker or a display including LEDs, or a device that is both an input device and an output device such as a touch screen user interface. In response to user actuation of the input device, the processing circuitry 802 may be configured to control the image sensor 808 to acquire an image of the barcode 182. The digital code converted by the processing circuit 802 using symbology and other processing in the memory circuit 804 may be displayed via the user interface 806 and/or may be sent to another computer for recording, further processing, reporting, etc.

In some implementations, the user interface 806 can include a display configured to visually display at least one of a digital image of the barcode (which can be a positive image or a reverse reflectance image printed in light reflective ink) and a digital code.

The processing circuitry 802 may be configured to convert by inverting data representing a digital image in a data file and converting the inverted data into digital code using a bar code definition or symbology in memory. For example, the processing circuitry 802 may first receive the scanned image data and then invert or reverse any pixels indicated as light to indicate them as dark, and conversely, invert or reverse any pixels indicated as dark to indicate them as light. The inverted image may be stored in memory and the inverted image data then processed according to the symbology stored in the memory circuit to determine the digital or alphanumeric data encoded by the bar code.

Fig. 10 illustrates an exemplary positioning of a scanner/imager in a medical fluid processing device, such as a blood processing device. As shown in the partial view of fig. 10, a blood processing device (e.g., a blood separation device, a plasma separation device, a blood processing device, etc.) has a housing 200, the housing 200 having a wall 202 and an aperture forming a window 204 in the wall. 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 hung from a hook 208 or other hanging member (e.g., a clamp) on the processing device. The window 204 may be made of glass that shields electromagnetic interference. The scanner 210 may be located within the housing 200 behind the window 204.

The scanner 210 may have any suitable design for scanning, imaging, or otherwise capturing two-dimensional barcodes, one-dimensional barcodes, and/or blood container labels as described herein, or employ any suitable technique 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 employ a laser, a camera, a CCD scanner, or other suitable imaging or scanning device or technique. One non-exclusive example of an imager/scanner that may be employed herein is the JE-227 model scan engine from Jadak Technologies, having offices in north stannoltz, new york, or similar device.

As described above, the scanner 210 is preferably mounted within the housing 200 for protection and positioned to optically view or scan the container 206 through the window 204. The scanner is positioned such that it scans or images a particular surface area of the container. More specifically, the scanner may be positioned to image a label 212 on the window-facing surface of the container, the label having information to be recorded as part of the process record. The information may be in the form of or encoded in a bar code. In the medical field in general, and in the blood collection and processing field in particular, aspects of containers and container labels may be subject to certain requirements of regulatory or standards-making subjects.

Advantageously, the scanner 210 in the illustrated embodiment may be configured to image the entire label 212, or substantially the entire label 212, including the barcode (if present on the label) for product information recording. To achieve this, the scanner may be specifically positioned within the housing. In the illustrated embodiment, the scanner 210 has a field of view 214 (which may have a vertical aspect and a horizontal aspect — only the vertical aspect is shown in fig. 10) and a focal length or focal length 216. To image the desired surface area of the solution container, a scanner having a vertical field of view of about 30 to 40 degrees and an equal or greater horizontal field of view may be positioned about 6 to 8 inches (about 15 to 20 centimeters) from the surface of the hanging container. This configuration may vary based on the size of the particular region to be imaged and the particular scanner employed without departing from this disclosure.

Examples of the invention

A positive image of the GS1 DataMatrix barcode was printed in white (unprinted surface area) on a black background on paper. A 2D barcode scanner attached to the Aurora 6R4601 plasma separator was used to scan the code. A Microscan verifier was used to successfully decode the data.

The arrangement as shown in the illustrated embodiments is merely illustrative. Although 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 are possible (e.g., variations in sizes, dimensions, structures, shapes and proportions of the various elements, values of parameters, mounting arrangements, materials, colors, orientations, etc.) without materially 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 this disclosure as described herein. The order of any process or method steps may be varied or re-sequenced according to alternative embodiments. Other substitutions, modifications, changes and/or omissions may be made in the design, operating conditions and arrangement of the preferred and other exemplary embodiments without departing from the scope of the present disclosure as expressed herein. It is also to be understood that changes in the embodiments of the disclosed invention are intended to be included within the scope of the claims.

Claims (12)

1. A method of printing a code on a flexible medical solution container, comprising:

providing a flexible medical solution container that is at least partially light transmissive;

storing a code comprising a number in a memory circuit;

converting the code including the number using a bar code symbology defining dark and light regions;

applying a light-reflecting ink to the container based on the bar code symbology, wherein the light-reflecting ink is applied in areas defined by the dark regions; and

applying a light absorbing ink to the container based on the bar code symbology, wherein the light absorbing ink is applied in areas defined by the light areas, whereby the applied light reflecting ink and light absorbing ink produce an inverted code representing the dark areas and the light areas defined in the bar code symbology.

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

3. The method of claim 1, further comprising manufacturing the flexible fluid container to include a port coupled to a section of tubing.

4. The method of claim 1, wherein the converting further comprises converting the code into a linear bar code symbology having a leading indicator with a first dark region followed by a first light region followed by a second dark region, wherein the light reflecting ink is applied to the first dark region and the second dark region, wherein the light absorbing ink is applied to the first light region.

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

6. The method of claim 5, wherein the code is converted into GS1 Datamatrix symbology for barcode structures.

7. A method of printing a linear bar code on a flexible medical solution container, comprising:

providing a flexible medical solution container that is at least partially light transmissive;

storing code comprising a number in a memory circuit;

converting the code including numbers using a linear bar code symbology defining dark bars and light bars; and

applying light-reflective ink to the container based on the linear bar code symbology, wherein the light-reflective ink is applied in areas defined by the dark bars, whereby the applied ink produces a reversed linear bar code representing the dark bars and the light bars defined in the linear bar code symbology.

8. The method of claim 7, further comprising manufacturing the flexible fluid container to include a port coupled to a segment of tubing.

9. 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, wherein the applying 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, further comprising manufacturing the flexible fluid container to include a port coupled to a segment of tubing.

12. The method of claim 7, wherein the linear barcode is a country pharmaceutical code comprising at least ten digits.