HK1068711B - Coding symbology and a method for printing same - Google Patents

Description

Coding symbology and method of printing same

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority from the same pending U.S. provisional application serial No. 60/280,073 entitled "coding symbology and method of printing the same", filed on 30/3/2001, which is hereby incorporated by reference in its entirety.

Technical Field

The present invention relates to a coded symbology comprising fixed information and variable information, and a method for transferring such a coded symbology. The invention is particularly applicable to flexible transparent thermoplastic containers for holding liquid products commonly used in medical procedures.

Background

Various foods, liquids and other substances can be aseptically packaged in flexible containers in the form of pouches made from sheets (webs) of flexible film, sheet stock or similar material sealed together along the outer edges. Such bag-like flexible containers have many advantages, including light weight, durability, and low manufacturing cost.

A variety of medical solutions are aseptically packaged in flexible containers in the form of pouches. These medical solutions may be: drugs, flushes (flushes), nutrients, irrigation fluids (irrigiting), respiratory therapy agents, dialysis fluids (dialysis), blood products, plasma derivatives, plasma expanders, blood substitutes, anticoagulants, blood preservatives, and the like. These solutions may be delivered to the patient through an administration tube assembly connected to the flexible container. Other medical solutions include enteric drugs, inhalation anesthetics, veterinary drugs, vehicles, and the like. The container may include one or more access tubes (access tubes) or access devices through which liquid is pumped during manufacture of the package to initially fill the container, and to which an administration set or the like may be connected for delivery of the liquid to the patient.

Bar codes are widely used in the medical industry to identify components in containers. For example, bar code identification systems enable hospitals to electronically track their drug inventories and subsequently invoice them on demand by patients. Bar codes are also used in automated drug dispensing systems to properly mix the correct and appropriate amounts of drugs and therapeutic agents. More importantly, the bar code also enables the hospital to monitor the medication or other therapeutic fluid to be infused into the patient by marking it with fixed information, such as a product code or number.

In the prior art, two-color systems are implemented in barcode systems. That is, a typical bar code consists of black lines on a white background. When a bar code reader reads a bar code, the black lines will absorb the laser light of the reader, while the white gaps will reflect the laser light of the reader to the reader, where the reflected information is converted into its corresponding analog counter(s). This two-color system naturally leads to the development of a two-step process for printing the bar code.

First, the container is passed through a printer which applies a reflective (usually white) background field to the bar code. The container is then passed through a second printer which applies a dark obscuration of the bar code over a background field. One common printing method is a stamping (die casting) system.

In a stamping system, a metal mold is stamped with a desired image or bar code, heated to a predetermined temperature, and applied to a substrate under pressure to transfer the image or bar code from a stamping foil. The foil acts as a carrier for the pigment (ink) and is fed between the stamping die and the substrate. There is a problem in that the mold has sharp edges, which often damage the aforementioned flexible substrate, thereby increasing the defective rate. And there is another problem that the production cost of the hot stamping die is high, and the manufacturing needs several hours or even several days. Thus, the stamping system is not suitable for printing images representing variable information such as lot number (lot number), batch number (batch number), expiration date, or any other data that varies over a fixed time period such as in minutes, hours, or days.

Thus, the stamping system can only be used to print fixed information such as product name, manufacturer, etc. One way to overcome this drawback is to print labels and apply these labels to products. Naturally, this increases the cost and reduces the productivity, and the label has a possibility of coming off the product.

Stamping systems present several other problems as they relate to the readability of bar codes on flexible transparent containers, such as those frequently used in the medical industry. A first problem with the readability of the images printed by the stamping system is that in such systems, due to the transparent (light absorbing) nature of the containers, a solid (light reflecting) background block needs to be printed on the containers before the dark (light absorbing) lines of the bar code can be printed on the containers. Not only does this increase the cost by involving two printing passes to obtain two colors, but printing solid background blocks using a stamping process is fundamentally difficult because air pockets are often formed in the ink, which cause voids in the solid blocks, rendering the bar code unreadable. In addition, since the background pieces themselves require more pigment or ink than the contrast strips, there is a possibility that pigment extracts and exudates will be present in the solution in the container.

A second problem is that since the stamping system uses variable heat, variable pressure, and fixed dwell time to transfer the image or bar code to the substrate, there is a problem of the ink running out or increasing too much, which can result in bar code unreadability or poor edge definition of the bar code symbology. To address this problem, the mold must be redesigned, reworked, or re-engraved at a smaller size so that the correct bar code size is obtained at the time of application. Alternatively, the size of the bar code symbology, including the spacing of the bars, may be increased if space limitations on the substrate permit. But do notBoth solutions, however, increase the cost and reduce the productivity. A third problem is that the inks in the stamping system are designed to adhere to the underlying substrate rather than to each other, thus further rendering the bar code unreadable and requiring the development of inks that stick to each other. Fourth, stamping typically produces bar codes with "D" or "F" American National Standards Institute (ANSI) scale readings ("A" represents the highest resolution image). See, for example, theInformation of the United states System national standard-bar code printing quality guide(American National Standards for information Systems-Bar Code Print Quality Guidelines), established by the American National Standards institute,1990 is published by the information technology industry Committee, which is incorporated herein by reference as if recited herein.

At least one attempt to reduce the problems associated with two-color, hot stamping systems has been made, as found in PCT patent application No. PCT/US99/05614, international publication No. WO 99/49408, which is hereby incorporated by reference as if set forth herein. The' 408 application discloses a container having a negative bar code (page 8, lines 22-24) produced using the stamping system described above. The bar code is a negative image because the light-reflecting portions of the underlying substrate correspond to the background spaces of a conventional bar code (typically white) and the light-absorbing portions of the underlying substrate correspond to the light-absorbing dark portions of a conventional bar code (typically black).

Earlier, the ability to print negative bar code images was known in the art, as evidenced by, for example, Pira International1995 published by Robert d.lamoreaux, page 176Bar code and other automatic identification systems(Barcodes and Other automatic identification Systems), which are incorporated herein by reference as if set forth herein. Despite the advantages of the monochrome system, the other problems described above with the stamping system remainHowever, there is the inability to print fixed and variable information in one pass of printing.

Unlike stamping systems, thermal transfer printing systems use lower heat to transfer an image (e.g., a bar code) from a print head by light contact with the substrate. Because the bar code is not printed under pressure, there is better bar code symbology edge definition. That is, thermal transfer printing typically produces bar codes with either "a" or "B" ANSI scale readings (scale reads). Furthermore, the inventors have found that when a thermal transfer system is used to print an "A" quality code, the same code produces a reading of "C" quality by a 10mil (mil) high density polyethylene overpouch (overpouch), which is well known in the medical arts.

Another advantage of the thermal transfer printing system is that since the print head does not include sharp edges like a hot stamp, the printing does not damage the flexible substrate, thereby reducing scrap rates. Another advantage is that the thermal transfer printing system uses less pigment or ink than a hot stamping system, thereby reducing the risk of exudates or extractables entering the container solution. A further advantage is that the thermal transfer print head has a higher flexibility than the hot stamping die, since the image information can easily be changed within a few minutes at the input terminal, as opposed to waiting hours, or even days for the hot stamping die to be redesigned, reworked, or even re-engraved. There are many such thermal transfer systems available from different manufacturers, e.g.(MARKEN) and Jaguar J27i4(Norwood MarkingSystem).

Another advantage of thermal transfer printing systems over hot stamping systems is that they are capable of printing smaller bar codes that can be read accurately. For example, depending on the substrate, to print a code of the same symbol level, the length required by a thermal transfer printing system averages about one-third to two-thirds of the length required by a hot stamping system. In summary, thermal transfer printing systems require less space and provide better bar code edge definition than hot stamping systems. These advantages enable variable information, including label copy information, about pharmaceutical and medical agents to be printed on either or both sides of the container. In contrast, the hot stamping method, due to size and definition limitations, allows only fixed information to be printed on one side of the container and variable information to be printed on the other side. These limitations increase the operation of turning the container over and require the operation of a second printing pass, which in turn increases costs and reduces productivity. Thus, thermal transfer printing systems have improved cost efficiency, time efficiency, and bar code image resolution over hot stamping systems. However, there remains a problem with printing high definition, monochrome bar codes containing fixed and variable information in a single pass.

The present invention is directed to solving these and other problems.

Summary of The Invention

The invention provides a novel identification system and a method for using the same. When compared to other, and as may not be presently adopted, and as exemplified by U.S. patent 6,139,495; 6,032,155, respectively; 5,845,264, respectively; in combination with the safety system described in 5,700,998, which is incorporated herein by reference as if fully set forth herein, the identification system may be used to control inventory, track patient inventories, monitor specific dosages, potentially reduce patient safety errors, and implement a variety of other devices and methods.

The coding symbology of the present invention includes a substrate and a plurality of light-reflecting segments disposed on the substrate separated by gaps. The gap on the substrate defines a light-absorbing portion. And the light-reflective and light-absorbent portions define a negative image bar code representing fixed and variable information.

The invention also provides a coded symbology detectable by a reader. It will be appreciated that the reader may be any form of bar code reader now known, the details of which form no part of the present invention. Typically, bar code readers direct a form of energy at the image and bar code and receive all or a portion of the energy reflected from the image and bar code. Preferably the reader will then convert the reflected energy into a form of data that is easily understood by a human.

The present invention also provides: the retroreflective portion is a mark that is detectable by a reader, whether or not the mark is visible to the human eye. That is, the light-reflecting portion may be present at wavelengths outside the visible spectrum. As is known in the art, barcodes, which may be fluorescent, are outside the visible spectrum and are the subject of 5,547,501 of U.S. patent, which is hereby incorporated by reference as if set forth in detail herein. In summary, the present invention encompasses both visible and invisible symbol encoding systems, or a combination of both, so long as the difference in reflectance between light-reflecting and light-absorbing portions disposed on a substrate enables the resulting image to be detected by a reader. If the indicia is visible to the unaided human eye, the indicia may have a color within the visible spectrum.

The substrate may be of any chemical composition, preferably comprising a thermoplastic or thermoset polymer, even more preferably the substrate comprises a medical container. In another embodiment, two or more symbol encoding systems are disposed on a substrate, wherein the combination of the two or more codes represents fixed information and variable information. Two or more codes may also be provided in a container system that includes at least one substrate and at least one material that form a container. The coding symbology or symbologies may be located anywhere on the container system. The present invention relates to a container system comprising a substrate forming a medical container, and a material forming an outer pouch covering at least a portion of the substrate.

The present invention also provides a method for transferring a negative image bar code to a sheet of material, comprising the steps of: first providing a sheet of material; a printer is then provided that is capable of transferring the negative image bar code to the sheet in response to a signal representative of the negative image bar code. According to the present invention, the negative image bar code represents fixed information and variable information. The negative image of the bar code is then transmitted by a signal to the printer and directed onto the sheet of material. Preferably the printer is a thermal transfer printer. The method of the present invention also contemplates that any predetermined number of negative image barcodes can be transferred in this manner.

Additional features and advantages of the invention will be described hereinafter that form the best mode for carrying out the invention.

Brief description of the drawings

FIG. 1 is a fragmentary perspective view of a coded symbology representing fixed information and variable information in a single collective image (collective image) transferred to a substrate.

FIG. 2 is a fragmentary perspective view of a coded symbology representing fixed information and variable information in at least two sets of images transferred to a substrate.

FIG. 3 is a fragmentary view of a container system having a substrate with a coded symbology representing fixed information and variable information and a material disposed on a portion of the coded symbology.

Fig. 4 illustrates the relative positions of the laser scanner and the bar code by comparative analysis.

Fig. 5 shows an example of a coded symbology produced by a stamping or thermal transfer method.

Best Mode for Carrying Out The Invention

While the present invention may be embodied in many different forms of embodiments, and will be described in detail herein, the disclosure of the preferred embodiments of the invention should be understood as follows: the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the broad aspect of the invention to the embodiments illustrated.

FIG. 1 illustrates a negative image bar code image representing fixed information and variable information transferred to a substrate. The bar code is shown generally at 20. The bar code 20 includes a plurality of retroreflective portions 22 separated by gaps 24. The gap 24 defines a light-absorbing portion 26. The light-reflecting portions 22 and the light-absorbing portions 26 define a negative image bar code 20 that represents fixed information and variable information. The bar code 20 and the light-reflecting portions 26 are disposed on a substrate 30.

The substrate 30 may be of any known chemical composition, including thermoplastic or thermoset polymers. Suitable thermoplastic or thermoset polymers are polyvinyl chloride, polyvinyl dichloride, polyolefins, polyamides, polycarbonates, polyesters, thermoplastic elastomers, polyimides, polyurethanes, ethylene vinyl alcohol copolymers, ethylene vinyl acetate copolymers, ethylene copolymers, propylene copolymers, acrylic copolymers, ethylene substituted acrylic copolymers, alpha-olefin substituted acrylic copolymers, hydrocarbon block copolymers, ethylene propylene diene polymers, nylons, monolayer film structures, and multilayer film structures, as disclosed in U.S. Pat. Nos. 6,168,862, 6,083,587, 5,998,019, 5,993,949, 5,935,847, 5,693,387, 5,686,527, 4,299,367, and 3,912,843, which are incorporated herein by reference as if set forth in detail herein. Alpha-olefins, preferably containing from about 2 to 20 carbons, can generally be produced by any method known. More specifically, the alpha-olefins are ethylene and propylene.

The chemical composition of the substrate 30 is preferably such that there is a difference in reflectivity between the substrate 30 and the light-reflective portions 22 that causes the light-reflective portions 22 to form indicia (not shown) that is detectable by a reader (not shown). As is known in the art, the preferred maximum reflectivity of the light-absorbing portion of the encoded symbology is about 25% in percent reflectivity, which is comparable to the preferred minimum reflectivity of the light-reflecting portion. It is not necessary to simultaneously achieve the maximum reflectance of the light-absorbing portion and the minimum reflectance of the light-reflecting portion. Preferably, the total reflectivity level of the code symbology is such that the retroreflective portions, preferably the code symbology, are detectable by a reader.

The indicia of the retroreflective portion 22 may be invisible to the unaided human eye or preferably visible to the unaided human eye so that the bar code 20 may be easily located and read by a bar code reader (not shown). The indicia of retroreflective portion 22 may be white, red, yellow, orange, gold, silver, or any combination thereof. The preferred color depends on the index of reflection of the selected substrate and on the wavelength of the energy used by the reader. As previously mentioned, it will be appreciated that any color may be used, provided that the difference in reflectivity between substrate 30 and retroreflective portion 22 is such that retroreflective portion 22 forms indicia (not shown) that can be detected by a reader (not shown).

According to the present invention, fixed information is defined as information that remains unchanged for a first period of time, and variable information is defined as information that changes for the first period of time. Examples of fixed information include, but are not limited to, the name of the product, the number of codes, the manufacturer, the National Drug number (National Drug Code), label copy data required by the federal Food and Drug Administration (FDA), or data required by the Health Industry Bar Code Council, now the Health Industry Business communications Council (hicc), and so forth. Variable information includes, but is not limited to, lot number, expiration date, serial number, production time, price, inventory control data, and concentration of the product.

FIG. 2 illustrates another contemplated commercial embodiment of the present invention and shows a fragmentary perspective view of a coded symbology representing fixed information and variable information in at least two grouped images. The coded symbology includes a first bar code 40 representing fixed information and a second bar code 50 representing variable information. The first bar code 40 is defined in part by a first plurality of light reflecting portions 42 spaced apart by gaps 44 and disposed on a substrate 60. The gaps 44 define a first set of light absorbing portions 46 that further define the remainder of the first bar code 40.

The second barcode 50 represents variable information. The second bar code 50 is defined in part by a second plurality of light-reflecting portions 52 spaced apart by gaps 54. The gaps 54 define a second set of light absorbing portions 56 that further define the remainder of the second bar code 50. It will be appreciated that the first and second plurality of light-reflecting portions 42, 52 may have the same chemical composition, but this is not required. In a preferred form of the invention, the first and second pluralities of retroreflective portions 42 and 52 are first and second indicia (not shown), respectively, that are recognizable by a reader as previously described. The first bar code 40 and the second bar code 60 are disposed on the substrate 60.

As with the indicia associated with retroreflective portion 22 of the previous embodiments, the first indicia and the second indicia of this embodiment may be invisible, or preferably visible, to the incoming unaided eye. The first indicia (not shown) of the first plurality of retroreflective portions 42 or the second indicia (not shown) of the second plurality of retroreflective portions 52 may be white, red, yellow, orange, gold, and silver. The preferred color depends on the index of reflection of the selected substrate and on the wavelength of the energy used by the reader. As previously mentioned, it will be appreciated that any color may be used, provided that the difference in reflectivity between the substrate 60 and the retroreflective portion 42, and between the substrate 60 and the retroreflective portion 52, respectively, forms a first mark (not shown) and a second mark (not shown) that are detectable by a reader (not shown).

The present invention contemplates that any predetermined number of bar codes can be placed on the substrate 60 by repeating this process. Additionally, it will be appreciated that the substrate 60 may include a predetermined number of symbologies, such as the bar code 20, wherein the fixed information and the variable information are within the same symbologies on the bar code 20. It will also be appreciated that the encoded symbology disclosed herein may be used with any existing bar Code symbology including, but not limited to, Code16K, Code 39, Code 49, Codabar, Code 128, UPC-E, UPC-A, EAN-8, EAN-13, reduced area symbology (RSS), composite symbol (PDF-417), Interleaved 25-Code (Interleaved 2-of-5(ITF)), and two-dimensional symbology. It is further understood that either one of substrate 30 or substrate 60, alone or in combination, may be used to further define the entire container or portions of the container. It is contemplated that the container may be a medical container for storing medical solutions, such as medications, flushes, nutrients, irrigation fluids, respiratory therapy agents, dialysis fluids, blood products, plasma derivatives, plasma expanders, blood substitutes, anticoagulants, blood preservatives, and the like. It is also contemplated that the container may also be a flexible container in the form of a pouch. By flexible container is meant a container having a mechanical modulus of less than or equal to 40,000psi when measured according to ASTM D-882.

As shown in fig. 2, the substrate has an inner surface 64 opposite the outer surface 62, and the outer surface 62 defines an inner surface (not shown) and an outer surface (not shown) of the container. The inventors contemplate that either the first bar code 40 or the second bar code 50 may be disposed on the inner surface 64 or the outer surface 62, or both surfaces. Any predetermined number of symbologies may be provided on either or both of inner surface 64 and outer surface 62. It is also contemplated that the first bar code 40, the second bar code 50, or any predetermined number of bar codes (not shown) may be oriented in any manner, including but not limited to adjacent, overlapping, or overlapping.

FIG. 3 is a fragmentary perspective view of a container system having a substrate with a coded symbology representing fixed information and variable information and a material disposed on a portion of the coded symbology. In one embodiment, there is a main container designated by the numeral 80. The main container 80 has a substrate 82 which may, but need not, have the same chemical composition as the substrate 30 or substrate 60 described above. As with the previously described embodiments, there are a plurality of light reflecting portions 72 separated by gaps 74, which are disposed on a substrate 82. The gap 74 defines a light absorbing portion 76. The light reflecting portion 72 and the light absorbing portion 76 together define the bar code 70 representing fixed information and variable information. The substrates 82 define an inner surface (not shown) and an opposite outer surface 84 of the main container 80.

As part of the container system, there is also a material 92 located over a portion of the bar code 70, where the bar code can be detected by a reader (not shown). The bar code 70 may be disposed anywhere on the substrate 82, or even on the material 92, so long as the bar code 70 is detectable by a reader (not shown). In accordance with other embodiments disclosed herein, the present invention also contemplates that any predetermined number of bar codes may be disposed on substrate 82, material 92, or both, and contain fixed information, variable information, or both.

In another embodiment of the container system, the material 92 is a portion or all of the outer bag 90. The outer bag 90 may cover a portion or all of the main container 80. Moreover, the present invention contemplates that the primary container 80 may include at least one peripheral edge 86 that may be heat sealed, high frequency sealed, or otherwise sealed using any known technique, the details of which form no part of the present invention. The material 92 may also be formed into the outer bag 90 by sealing at least one peripheral edge 94 using any known technique, the details of which form no part of the present invention.

The substrate 82 can be made of any chemical composition so long as the difference in reflectance between the light reflecting portions 72 and the light absorbing portions 74 that form the bar code 70 is detectable by a reader (not shown). Likewise, the material 92 may be of any known chemical composition so long as the difference in reflectance between the light reflecting portions 72 and the light absorbing portions 74 allows the bar code 70 to be detected by a reader (not shown) when the bar code 70 is disposed thereon. Preferably, substrate 82 and material 92 are comprised of chemical components sufficient to withstand the autoclaving process without bonding to each other.

It is to be understood that the invention may be played in other embodiments, several of which are described below, without departing from the spirit or central characteristics of the invention. Accordingly, the present examples, embodiments, and examples are to be considered as illustrative and not restrictive, and the invention is not to be limited to the details given herein.

Examples

1. Coding symbology having a single barcode

As described above, the identification system of the present invention provides a coded symbology disposed on a substrate. The invention also provides a plurality of light-reflecting portions separated by gaps, which are disposed on the substrate. Undisturbed area (undisturbed area) under the light reflecting portion of the substrate defines the light absorbing portion. The light-reflective portion and the light-absorbing portion together define an image of the bar code. In a preferred form of the invention, the light-reflective and light-absorbent portions define a negative image of the bar code.

2. Coded symbology having two or more barcodes

When the second barcode is employed, the barcode is formed in the same manner as the first barcode. That is, a second plurality of light-reflecting portions separated by gaps is provided on the substrate. Undisturbed regions beneath the light-reflecting portions of the substrate define a second set of light-absorbing portions. The second plurality of light-reflecting portions, together with the second set of light-absorbing portions, define a second bar code. The present invention recognizes that the method is capable of generating any predetermined number of barcodes. It will be appreciated that when two or more barcodes are employed, the barcodes need not be disposed in physical contact with each other, adjacent to each other, or even on the same substrate, but such embodiments are contemplated.

3. Container system

a. Main container with a bar code

The present invention also provides such a substrate: which forms a container that can be used as a primary container in a variety of container systems that will be described herein. In one embodiment, there is a material on a portion of the substrate, or on the barcode of the substrate, or both. The bar code is disposed on the substrate in the manner previously described, and is detectable by the reader as previously described, and represents fixed information and variable information as previously described. Also, the material of each container system may have the same chemical composition as the substrate described previously, but this is not necessary to practice the invention. The primary containers embodied in the various container systems of the present invention may also be of the same chemical composition, or material, or both, as the substrates, as previously described, but this is not necessary to the practice of the present invention. The material provided by the present invention also includes a second container such as an overpouch.

It will be appreciated that the primary container has an inner surface and an opposite outer surface. Any predetermined number of bar codes may be provided on the inner or outer surface, or both surfaces of the main container, so long as each bar code is detectable by the reader.

As previously mentioned, the retroreflective portion of this particular embodiment is also a mark detectable by a reader, either visible or invisible to the unaided human eye, or a combination of both. If the retroreflective portions are embodied in the visible spectrum, their color may be white, red, yellow, orange, gold, silver, or any color, as previously described, so long as the difference in reflectance between the retroreflective portions disposed on the substrate and the light-absorbing portions defined on the substrate is such that the retroreflective portions, and preferably the resulting image, are detectable by the reader.

b. Main container with two or more bar codes

In a particular embodiment, the main container has a substrate, and the substrate has a first barcode disposed thereon. The first bar code is defined by a first plurality of light-reflecting portions on the substrate, and a first set of light-absorbing portions defined by gaps in the first plurality of light-reflecting portions. The first bar code represents fixed information, variable information, or both.

In this embodiment, there is also a second barcode on the substrate of the main container. The second bar code is defined by a second plurality of light-reflecting portions and a second set of light-absorbing portions defined by gaps in the second plurality of light-reflecting portions. The second bar code represents fixed information and variable information, or both. It will be appreciated that the location of the first and second bar codes on the substrate is not critical, so long as both bar codes can be detected using a bar code reader. The present invention contemplates that any number of barcodes may be formed in this manner. There is also a material as part of the container system that is positioned on a portion of the first bar code or the second bar code, or both, as previously described.

c. The main container and the material each having a bar code

In yet another embodiment of the present invention, a first bar code representing fixed or variable information is defined on a substrate forming a portion or all of the main container. The first bar code is formed in the general manner as previously described. The substrate has an inner surface on which a first bar code can be disposed and an outer surface. This embodiment also provides a material, as previously described, that is located on a portion of the substrate or the first bar code or both. The material may further define a secondary container such as an outer bag, dust cover, or the like.

The second bar code represents fixed information or variable information and is defined in the manner previously described. That is, the second barcode is defined by a second plurality of light-reflecting portions separated by and disposed on the gaps, and a second set of light-absorbing portions defined by the gaps of the second plurality of light-reflecting portions. The material has a first side adjacent the primary container, and a second side opposite the first side, on which a second bar code, or any number of bar codes, may be disposed. The combination of the first barcode and the second barcode represents fixed information and variable information. As with any of the containers described herein, two or more barcodes may be disposed on the substrate, or on the material, or both.

d. Materials having one or two or more barcodes

The present invention also provides another embodiment for a container system in which the substrate forming a portion of the main container does not have a bar code image disposed thereon. In contrast, the materials described heretofore have at least one bar code disposed thereon. A bar code may be used to represent both fixed and variable information. In another embodiment, the substrate still does not include a barcode, but the material has two or more barcodes disposed thereon. Each bar code represents fixed information or variable information, or both. In addition, a first side of the material is adjacent the substrate and a second side is opposite the first side, on which any number of bar codes may be disposed. The exact location of the barcode is not important as long as the barcode is detectable by the reader. The bar code is formed in the general manner described previously. If desired, the substrate may contain any predetermined number of bar codes representing fixed information, variable information, or both.

4. Method of producing a composite material

The present invention also provides a method for transferring a negative image bar code to a sheet of material. The first step provides a sheet of material. The sheet may be of any known chemical composition so long as the difference in reflectance between the negative image bar code and the material when the negative image bar code is transferred thereto is sufficient to be detected by a reader. The next step in the method is to provide a printer capable of transferring the negative image to the sheet in response to a signal representing a negative image bar code having fixed information and variable information. The signals may be generated by a computer, software execution, circuitry, or any other method known in the art, the details of which are not part of the present invention. The printer may be of any type generally known, preferably a thermoprinting printer, a laser printer, an inkjet printer, a flexographic printer, or a thermal printer; more preferred is a thermal transfer printer.

The next step is to transmit a signal to the printer and then transfer the negative image bar code to the sheet of material. The sheet may be a thermoplastic or thermoset polymer as previously described. As mentioned above, the exact chemical composition of the material is not important, so long as the difference in reflectance between the negative image barcode and the material is sufficient to enable the negative image barcode to be detected by a reader.

The negative image bar code may be transferred to any location on the sheet, including the inner or outer surface of the sheet. The present invention also includes transferring the negative image bar code to a sheet of material containing another bar code, such as a label copy bar code or even another negative image bar code. The sheet may also form part or all of the container, or form part or all of the material used in the container system described above, for example. The present invention also provides for transferring two or more negative image barcodes, separately or together, where the negative image barcodes represent fixed information, variable information, or both.

Comparative analysis of thermal transfer printing and thermoprinting printing

a. Background and materials

The quality and size of the heat transfer printed bar code will be compared to the hot stamped printed bar code. To perform this analysis, which will be described in detail below, it was investigated whether each bar code could be decoded by scanning and produced an average ANSI letter grade "B" or higher. In addition, the inventors examined whether each of the heat-transfer bar codes can be decoded by a 1000ml overpouch made of high density polyethylene, having a thickness described below, sold under the name Fina by AtoFina Chemical & Oil, with a specific rating of 7394.

The comparative analysis employs an assay procedure that includes the use of a precision instrument PSC QuickCheck^TM820 Laser/locator compatible bar code Verifier (Laser/Mouse compatible bar code modifier) (PSC, inc., Webster, NY) SN: 83987 for decoding bar codes and evaluating signal print quality according to a published ANSI standard, ANSI X3.182, wherein ANSI X3.182 is included in ANSIBar code printing quality guide(Bar CodePrint Quality guide), 1990 edition. The criteria are listed below.

Table 1 shows the trace group identification (tracking group identification) given to the test container. Group A included 100 containers, purchased from Abbott Laboratories (sterile Water for injection, USP 2000 ml NDC 0074-. Group a does not require additional redesign, sterilization processing or packaging, etc., nor does it require such operations to be performed in this commercial embodiment. Group B includes 300 containers available from Baxter Healthcare Corporation, known as PD185 TCSolution bag containers, wherein each container is printed with a bar code. Table 1 also specifies that 60 containers in group B are labeled and enclosed in an outer bag of predetermined thickness.

TABLE 1

Other devices used in this analysis include:

outer bag: (1000mL) 100% Fina HDPE Grade-7394

1 roll of 3M 810 scotch tape (c)“Magic^TM”Tape)ID：34-8506-4916-0

1 roll of Thermal transfer Ribbon (Thermal Ribbon) ID: TTR-71521

N-300 PVC membrane tube,

the stock number 332116 of the stock is,

batch number: NC OCT.14' 99C 15 Box 1.

Cyclohexanone, batch number: 4872T 15641 effective period: 12/6/01.

N＝300 PD185 TC 1000mL double-ported container:

traceability (Traceability): 3-16-67-134

Batch number: NC 8-31-00C76 Box 4

100N-sterile water for injection, USP 2000 ml NDC 0074-

Jaguar J27-14 thermal printer, SN: I4B0066

PSC Laser Scanner (Laser Scanner), model: 4100+ A3043

6-mil hole location bar code reader (alert Mouse Wand) (660nm)

10-mil hole positioning bar code reader (660nm)

N ═ 1 scale ID: l12687 checks validity period: 04/06/02

Digital Caliper (Digital Caliper) ID: the L8435 marks the validity period: 03/30/02

b. Printing standardized heat transfer printing bar code and scanning thermoprinting bar code before disinfection

Prior to printing a heat-transfer bar code onto group B containers (Barxter), the bar code symbology of group A (Abbott) is first identified and the encoded data is verified as human-readable text, a job performed by Quick Check^TM820 bar code check machines were done using laser scanners.

Table 2 shows the encoded data, human readable data format, and the size length/width of Abbott barcode (N ═ 100).

TABLE 2 Abbott

Table 2 illustrates the symbology, data, number of characters, format, and size length/width of the Abbott barcode. Abbott barcodes adopted the Code 128 version of the UCC/EAN standard. The data listed in the "encoded data" column is by Quick Check^TM820 read out by the laser scanner of the testing machine.

The dimensional width is measured using a calibrated ruler (calibed roller).

The "X" dimension (length) is measured with a calibration ruler from the outside edge of one quiet zone (quiet zone) to the outside edge of the opposite quiet zone.

The "Y" dimension (height) is measured from the top edge of the quiescent zone to the bottom edge of the same quiescent zone.

This "Y" dimension (height) has no analytical significance for this experiment during the test.

Abbott barcodes were reproduced using the imaging software of a Jaguar printer. Once the size layout and logo is generated, the image is downloaded to a Jaguar handset (hangset). The thermal printer produces the shortest element width (total width of barcode elements ═ total length of the measurement of the barcode), the number of encoded data characters, and the various text recognized in the Abbott barcode for the same symbology. The following steps detail the manner in which the Abbott barcode recognition process proceeds:

quickcheck is paired with a calibration standard barcode provided in the user manual (Quick-Check 600 series user manual provided by PSC Inc., second edition 1994, Part No QCOM600)^TMThe 820 bar code verifier was calibrated and then connected to a Laser Scanner ("Scanner"). The scanner was placed approximately 3 "directly above the bar code before scanning. As shown in fig. 4, the scanner is positioned: i.e., the top edge of the scanner is located over the "top" side of the bar code and the bottom edge of the scanner is located over the "human readable data" side of the bar code. As shown in fig. 4, the bore surface of the scanner is positioned at an angle of about 90 ° above the bar code.

The trigger (trigger) of the scanner is then depressed and the scanner is held to determine the correct scan position. This scan does not record any data. As shown in fig. 5, the laser beam emitted from the scanner's aperture should span the full width of the bar code. As shown in fig. 5, the laser beam is moved to about the middle of the bar code by moving the scanner in the lateral or vertical direction without changing the angle or distance described above. The trigger of the scanner is released and the position of the scanner is fixed by: the position parameters of the scanner do not change.

The trigger of the scanner is again depressed and held, thereby decoding and identifying the symbology and encoded data of the group a barcode. The scanner results are recorded and the above steps are repeated to scan the remaining bar code samples of group a. The trigger is depressed only when the scanner is used to scan a bar code. If an element of the scanning test environment changes (e.g., illumination), the scanner is recalibrated as described above.

Table 3 shows the copying of Abbott (group A) barcode tags to Baxter (group B)On the container.

The following barcode element width dimensions of N-150 produce an ANSI rating comparable to that of Abbott barcodes. (see Table 8)

X size: 22mm Y size: 10mm

The following barcode element width dimensions of N-150 yield higher ANSI ratings than the Abbott barcode width dimensions. (see Table 8)

X size: 52mm Y size: 10mm

One bar code is printed on 300On the container and placed inside a plastic bag. These bar codes are randomly printed on the area of the container.

TABLE 3

c. Shadow test

The "shadow" test is a visual inspection test performed during bar code calibration to determine the integrity of the bond strength of the label to the substrate. The test employsMagic^TMTape 810, purchased from 3M and identified above asThis tape creates a shadow of the bar code to which it is applied. The shadow is generated because a tape label of a printer is attached to the tape while the tape is applied to or removed from the bar code. The amount of "dark shadow" observed on the tape is then used to assess the integrity of the bar code surface, which can withstand abrasive contact or resist melting under extremely high temperature conditions. A satisfactory tape test result will result in about 50% of the ribbon label being transferred to the tape. The test also helps to visually assess any degradation in the quality of the bar code. The test was performed immediately following the printing production process and was performed on only 300 specimens from group B. Table 4 lists the results:

baxter Table 4

Printing size:	a disinfection stage:	sample size:	0-50％：	51-100％：
					22mm×10mm	before sterilization	150	150	0
					Printing size:	a disinfection stage:	sample size:	0-50％：	51-100％：
52mm×10mm	before sterilization	150	150	0

Following the printing step, scotch tape is applied to the bar code. A small trace (0-50%) of foil can be seen on the strip for all prints. The scotch tape test results resulted in less than 50% of the label being transferred to the scotch tape, which made it a good print. After the scotch tape was removed from the bar code, there were no visible peeling stripes on any of the bar codes. Table 4 shows the results of data generated for group B barcodes (1) 52X 10mm and (2) 22X 10 mm. Each of the sample volumes 150 is selected from the respective group.

d. And (3) bar code inspection scanning: ASNI rating report (before disinfection)

The ANSI grade report is a separate scan-through report on the number of scans used to arrive at the final ANSI symbol grade. The report being of ANSI described previouslyBar shape Code printing quality guideThe method of (1) scanning a full-face. Then proceed to pair(group B) following step of the vessel. Abbott (group a) barcodes do not report results because the pre-sterilization steps of Abbott containers are not applicable to this protocol.

First, a 6mil aperture positioning bar code reader is attached to the scanner. The Quick Check is then run before the bar code is scanned for identification^TM820 scanner for calibration (as described previously). Then, to increase accuracy, the barcode was scanned 10 times using a Quick Check tester. Each single scan of the 10 scans was averaged by the Scanner and recorded at the time of the scan. The scanner then reports each scan level in alpha characters. Each barcode of the B group of 300 containers was scanned by positioning a barcode reader rolling over the barcode and across the middle of the barcode. Table 5 lists the detailed results.

ANSI rating (pre-sterilization) results:

TABLE 5 Baxter (group B) -6 mil positioning Bar code reader

Table 5 shows that the overall average ANSI rating produced by thermal transfer printing produced a rating of "C" in sample size 150(22mm x 10mm bar code) and a rating of "B" in sample size 150(52mm x 10mm bar code). The total number or ensemble average is the average of each individual sample scan after 10 scan passes. The rating of the stamped bar code was tested using a 6mil hole positioned bar code reader. The samples were tested after printing and before filling and bagging.

e. Filling in

Table 6 shows the method for(group B) filling of container and air amount:

TABLE 6

Size of the container	Amount of solution (mL)	Air volume range (cc)
			1000mL	1050mL±20mL	55cc±20cc

All 300 containers were filled using the specifications listed in table 1.

f. Overpouch assembly and sterilization cycle

All 300 containers of group B were transferred to a Vertrod sealer. A stock roll of 100% HDPE film was cut to a length of 131/2 "x 61/2" (see Table 1 for thickness of individual stock rolls). The film was then sealed manually using a Vertrod sealer. No defects were visible in the overpouch material. These containers are loaded into an outer bag and then sealed. The samples were loaded onto a sterile tray with the barcode printed side up so that the barcode did not come into direct contact with the tray. The sterilization Cycle was then run according to specification 14-04-01-199 Cycle No.04-026 at maximum time and temperature conditions (i.e., 56.0 minutes at 252 ℃ F.).

g. And (3) bar code checking and scanning: scanning simultaneous decoding (after disinfection)

TABLE 7

Table 7 shows that all barcodes can be decoded when scanned.All 300 barcodes on the (group B) containers and all 100 barcodes on the (group a) Abbott containers were able to pass through their respective outer bags and be decoded with a Laser Scanner using the scanning procedure described above. Up to 10 such scan tests were performed. The number of scans actually required to decode each individual cell is not recorded. Only the observation flag (observationnotte) is recorded for the unit that cannot be decoded, and there is no unit that cannot be decoded.

In some cases, water droplets can be seen in the Baxter (group B) overpouch, due to the near-future sterilization. The outer bag is then pressed onto the main container film surface, thereby dissipating or removing the water droplets. The wrinkles appearing on the outer bag were flattened by human hands. It can be seen that the Abbott container is completely dry. When decoding the bar code, the outer bag does not need to be removed.

h. And (3) bar code checking and scanning: ANSI grade report (after sterilization)

For each of the 400 specimens in groups a and B, the respective outer bag was removed, the port tube (port tube) was cut with scissors, and all the liquid of the specimens was completely drained. Each bar code is then scanned using the scanning process detailed above and an ANSI grade report is generated. Scanning 300 bar codes with 6mil hole positioning bar code readerAnd (4) sampling. 100 Abbott samples could not be scanned using either a 6mil well positioned bar code reader or a 10mil well positioned bar code reader. An inherent difference between positioning a barcode reader and a laser scanner is that positioning a barcode reader provides a level of reflectivity, whereas a laser scanner does not. This information can be used as a supplemental analysis tool to guide the evaluation of the print quality of the bar code during a trial production print quality control verification process.

Then, 300 pieces of the Chinese characters are used forA 15 square inch piece of the specimen was cut from each outer bag contained in the bag and pressed against the bar code for scanning the bar code through the cut outer bag portion. The wrinkles appeared were flattened with human fingers. The bar code is scanned through the outer bag using the same scanning procedure described above and an ANSI grade report is generated. All scanning through the outer bag was done using a 6mil aperture positioning bar code reader. The same procedure was repeated for 100 Abbott barcodes, except that the barcode reader was positioned using a laser scanner instead of a 6mil well. Moreover, the group B bar code is scanned again by the laser scanner, thereby verifying that the same end result can be achieved by positioning the bar code reader and the laser scanner. The following tables and figures illustrate these results.

Table 8 ANSI rating (after sterilization); the results outside the bag are as follows:

table 8 shows the total average ANSI rating produced by thermal transfer and stamping. The total number or ensemble average is the average of each individual sample scan after 10 scan passes. The table also reflects the average ANSI rating of the bar codes tested on the outside of the respective bags. These samples were tested after printing, filling, bagging.

Thermal transfer bar code (group B):

the thermal transfer produced an average ANSI rating of "C" for a 22mm by 10mm sample size of Baxter barcode 150 and an average ANSI rating of "B" for a 52mm by 10mm sample size of Baxter barcode 150. The grade of the thermally transferred bar code was tested using a 6mil aperture positioned bar code reader. In addition, the same results were produced using a laser scanner.

Hot stamping (group a):

in both table results, the stamping print produced an average ANSI rating "C" from a sample size of 100. And scanning the hot stamping bar code by adopting a laser scanner. When testing hot stamped bar codes, it is not feasible to use either a 6mil aperture or a 10mil aperture to position the bar code reader.

Table 9 ANSI rating (after sterilization); in-bag results:

watch 10

TABLE 11 Abbott-72mm by 12mm Bar code (laser scanner)

The printing method comprises the following steps:	and (3) disinfection:	sample size:	the scanning times are as follows:	bag thickness (mils):	average grade:
						thermoprinting	Rear end	42	10	4.5	C

Table 9 shows that for 42 (21 laser scanners +21 positional barcode readers) 22mm x 10mm Baxter barcode samples, an overall average ANSI rating of "C" was generated. Table 10 shows that for 42 (21 laser scanners +21 positional barcode readers) Baxter barcode samples of 52mm x 10mm, an overall average ANSI rating of "B" was generated. Table 11 also reflects that the 42 (laser scanner) hot stamped (Abbott) barcodes detected by their respective pockets produced an overall average ANSI rating of "C". The total number or ensemble average is the average of each individual sample scan after 10 scan passes. The grade of the heat transfer (Baxter) bar code was tested using a 6mil aperture positioned bar code reader and a laser scanner. The size of each Baxter bar code is adopted through various outer bag thicknessesThe number of samples was 130-150 to test the print quality. These samples were tested after printing, and after filling and bagging.

The above shows that the thermal transfer printing process is capable of reducing Abbott barcode image size (width) by about 69% and produces an equal average ANSI rating of "C" outside and inside the pouch. In the second part of the experiment, the thermal transfer printing process was able to reduce the Abbott barcode image size (width) by 28% and produce an equivalent average ANSI rating "B" outside the pocket and inside the pocket, so that the Abbott barcode only reports an average reading "C" for the ANSI rating (outside the pocket). The thermal transfer printing process has the flexibility to print a predetermined barcode image print size through software control. The quality of the bar code image is verified during the bar code print verification process. The verification process requires that the group a and group B barcodes be able to be scanned and decoded. The ANSI rating data above, particularly with respect to the 52mm by 10mm group B bar code, illustrates that the image quality of the bar code produced by thermal transfer is less likely to require reprinting of bad bar codes based on the higher print quality produced by thermal transfer.

It will be understood that the invention may be embodied in other specific forms without departing from the spirit or central characteristics thereof. Accordingly, the present examples and embodiments, therefore, are to be considered in all respects as illustrative and not restrictive, and the invention is not to be limited to the details given herein.

Claims (28)

1. A medical container having a coded symbology comprising:

a transparent substrate (30) defining a portion of the container;

a plurality of light-reflecting portions (22) separated by gaps (24) and disposed on the substrate, the gaps defining light-absorbing portions (26), wherein the light-reflecting portions and the light-absorbing portions define a negative image bar code (20) representing fixed information and variable information, and wherein the negative image bar code is detectable by a reader.

2. The container of claim 1, wherein the light-reflective portions are indicia detectable by a reader.

3. The container of claim 2, wherein the indicia is visible to the unaided human eye.

4. The container of claim 3, wherein the color of the indicia is selected from the group consisting of white, red, yellow, orange, gold, and silver.

5. The container of claim 2, wherein the indicia is invisible to the unaided human eye.

6. The container according to any one of claims 1 to 5, wherein the fixed information is selected from the group consisting of: product name, Product manufacturer, Universal Product Code, Universal Product model Number, National Drug Code, Health Related National Industry Code, and label copy data.

7. The container according to any one of claims 1 to 5, wherein the variable information is selected from the group consisting of: batch number, expiration date, serial number, production time, price, inventory control information, and concentration.

8. The container of any one of claims 1-5, wherein the substrate comprises a thermoplastic polymer or a thermoset polymer.

9. The container of claim 8, wherein the thermoplastic or thermoset polymer is selected from the group consisting of: polyvinyl chloride, polyvinyl dichloride, polyolefins, polyamides, polycarbonates, polyesters, thermoplastic elastomers, polyimides, polyurethanes, ethylene-vinyl alcohol copolymers, ethylene-vinyl acetate copolymers, ethylene copolymers, propylene copolymers, acrylic copolymers, ethylene-substituted acrylic copolymers, alpha-olefin-substituted acrylic copolymers, hydrocarbon block copolymers, ethylene propylene diene polymers, nylons, wherein the thermoplastic or thermoset polymer is a monolayer film structure or a multilayer film structure.

10. The container of claim 9 wherein the polyolefin is produced from an alpha olefin having from 2 to 20 carbons.

11. The container of claim 10 wherein the α -olefin is ethylene or propylene.

12. A container according to any one of claims 1 to 5, which is a flexible container in the form of a pouch.

13. A medical container system, comprising:

a main tank (80);

a transparent substrate (82) defining a portion of the main container;

a plurality of light-reflecting portions (72) separated by gaps (74) and disposed on said substrate, the gaps defining light-absorbing portions (76), wherein the light-reflecting portions and the light-absorbing portions define a negative image bar code (70) representing fixed information and variable information, and wherein the negative image bar code is detectable by a reader; and

an outer bag (90) formed of a material (92) covering the primary container, the material (92) being located on a portion of the primary container.

14. The medical container system as claimed in claim 13, wherein the light-reflective portion is a mark detectable by a reader.

15. The medical container system of claim 14, wherein the indicia is visible to the unaided human eye.

16. The medical container system of claim 15, wherein the color of the indicia is selected from the group consisting of white, red, yellow, orange, gold, and silver.

17. The medical container system of claim 14, wherein the indicia is invisible to the unaided human eye.

18. The medical container system as in any of claims 13-17, wherein the fixed information is selected from the group consisting of: product name, Product manufacturer, Universal Product Code, Universal Product model Number, National drug Code, National Health related industry Code, and label copy data.

19. The medical container system as in any of claims 13-17, wherein the variable information is selected from the group consisting of: batch number, expiration date, serial number, production time, price, inventory control information, and concentration.

20. The medical container system of any of claims 13-17, wherein the substrate comprises a thermoplastic polymer or a thermoset polymer.

21. The medical container system of claim 20, wherein the thermoplastic or thermoset polymer is selected from the group consisting of: polyvinyl chloride, polyvinyl dichloride, polyolefins, polyamides, polycarbonates, polyesters, thermoplastic elastomers, polyimides, polyurethanes, ethylene-vinyl alcohol copolymers, ethylene-vinyl acetate copolymers, ethylene copolymers, propylene copolymers, acrylic copolymers, ethylene-substituted acrylic copolymers, alpha-olefin-substituted acrylic copolymers, hydrocarbon block copolymers, ethylene propylene diene polymers, nylons, wherein the thermoplastic or thermoset polymer is a monolayer film structure or a multilayer film structure.

22. The medical container system as claimed in claim 21, wherein the polyolefin is produced from an alpha olefin having from 2 to 20 carbons.

23. The medical container system as claimed in claim 22, wherein the α -olefin is ethylene or propylene.

24. The medical container system as claimed in any one of claims 13 to 17, which is a pouch-like flexible container system.

25. The medical container system as claimed in any of claims 13 to 17, wherein the transparent substrate on which the negative image barcode is located is part of the main container.

26. The medical container system as claimed in any of claims 13 to 17, wherein the transparent substrate on which a portion of the negative image barcode is located is formed from said material.

27. A method of transferring a negative image bar code representing fixed information and variable information onto a sheet of transparent material that will form part of a medical container or container system, said method comprising the steps of:

providing a sheet of transparent material;

providing a printer capable of transferring a negative image bar code to the sheet of transparent material in response to a signal representing the negative image bar code, the negative image bar code representing fixed information and variable information; and

transmitting the signal to a printer; and

the negative image bar code is transferred to the sheet of material.

28. The method of claim 27, wherein the printer is a thermal transfer printer.