Abstract:
Systems and methods for labeling, identifying, and tracking data related to consumable substance include encoded information related to the substance itself, its container, and/or an animal (e.g., human, feline, canine, livestock) intended to receive the substance in vivo.

Description:
RELATED APPLICATIONS 
       [0001]    This application claims the benefit of co-pending U.S. Provisional Patent Application Ser. No. 62/278,758, filed 14 Jan. 2016, and entitled “Systems and Methods for Labeling, Identifying, and Tracking Data Related to Consumable Product,” which is incorporated herein by reference in its entirety. 
     
    
     BACKGROUND 
       [0002]    This invention relates generally to the labeling, identification, and/or tracking of data related to consumable products, and more particularly to coding and related systems used in marking and tracking in vivo consumable products (e.g., food, medication, vitamins, etc.) and/or their containers. 
         [0003]    Assurance as to substances to be consumed within or delivered into an animal body (e.g. a human body) cannot be overstressed. Humans assess items or materials to be consumed or otherwise taken in vivo by many indicators, including visible physical characteristics of a substance, tactile perception, through olfactory analysis, and through taste, usually in that order and sometimes in combination. However, there are times when the identity of a product may not be discernible by any of the senses, or it may be dangerous to do so. Such is the case with pharmaceuticals and fluids to be introduced into an animal body (e.g., introduced orally, percutaneously, and/or intravenously into a human body). 
         [0004]    In conventional syringe-filling operations for dosed or pre-filled syringes, for example, a filling machine was generally manually programmed with information such as syringe size (or capacity) and/or dosage volume (e.g., in milliliters). At some time other than the contemporaneous filling process, syringes may be tagged with a label, such as an adhesive label, in an attempt to identify the contents of the syringe. However, because labels were usually affixed to syringes after a manufacturing/filling process, chances of mislabeling and, therefore, substance misidentification increased. 
         [0005]    The art of information management, creation, and display in conjunction with food and/or drug administration would be enhanced by systems and methods for logging, verification, and confirmation substantially contemporaneously with administration. 
       SUMMARY OF THE INVENTION 
       [0006]    The present invention relates to improved systems and methods for preferably permanently (i.e., indelibly) labeling, identifying, and/or tracking information or data related to a consumable, preferably digestible product (e.g., food, medication, vitamins, etc., in liquid or solid form). 
         [0007]    An embodiment of a system according to the present invention includes a container for containing a consumable substance and configured to deliver the consumable substance to an animal. A machine-readable code is indelibly placed on the container, wherein the machine-readable code is encoded with data representative of information related to at least one of the container, the consumable substance contained within the container, and the animal to which the substance is to be administered. 
         [0008]    According to an embodiment of a system according to the present invention, the container may be a syringe, a transdermal patch, a gravity feed bag (e.g., IV bag), a capsule, or a coated tablet. 
         [0009]    According to another embodiment of a system according to the present invention, the machine-readable code may be laser etched into a surface of the container. 
         [0010]    According to yet another embodiment of a system according to the present invention, the information related to the consumable substance contained within the container includes at least one of substance ingredients, possible side effects caused by the substance, a substance production date, a substance production time of day, and a substance expiration date. 
         [0011]    According to still another embodiment of a system according to the present invention, the information related to the container includes at least one of a container capacity, a container type, a manufacturer lot number for the container, a container serial number, a container production date, a container production time of day, a container expiration date, and a list of compatible contents. 
         [0012]    According to a further embodiment of a system according to the present invention, the information related to the animal to which the substance is to be administered includes at least one of a postal address, a telephone number, an e-mail address, a health insurance company name, a health insurance policy number, a social security number, a payment account, a birthdate, age, prescribed dosage, and prescribed dosage schedule. 
         [0013]    According to a still further aspect of a system according to the present invention, the machine-readable code may be a one-dimensional machine-readable code (e.g., conventional bar code) or a two-dimensional machine-readable code (e.g., QR code). 
         [0014]    According to another embodiment of a system according to the present invention, the machine-readable code is encoded with data representative of information related to a name of at least one of a prescribing physician, a pharmacist filling a prescription of the consumable substance, and an administering physician. 
         [0015]    According to still another embodiment of a system according to the present invention, a dispensing machine may be provided with a plurality of consumable substances. 
         [0016]    An embodiment of a method according to the present invention includes delivering a consumable substance and providing data therefor. The method includes the steps of receiving a container that includes a machine-readable code, preferably indelibly placed thereon, and containing a consumable substance. The machine-readable code is scanned by a machine and data related to the code is displayed and reviewed. The consumable substance is then administered to an animal (e.g., human). All steps may occur in an administration environment including the animal. The data is representative of information related to at least one of the container, the consumable substance within the container, and the animal to which the consumable substance is to be administered 
         [0017]    According to another embodiment of a method according to the present invention, the animal has a body and the container is configured to administer the consumable substance through direct insertion of the consumable substance into the body of the animal (e.g., oral, intravenous, oral, vaginal, anal, or percutaneous insertion). 
         [0018]    According to still another embodiment of a method according to the present invention, the method may include the step of providing positive feedback after the scanning step, the positive feedback confirming, indicating, or authorizing the step to administer the consumable substance to the animal. 
         [0019]    According to yet another embodiment of a method according to the present invention, the method may include the step of scanning the machine-readable code after completing the administering step. 
         [0020]    According to a further embodiment of a method according to the present invention, the method may include the step of creating a data record after the scanning step. The data record may include data representative of at least one of the date of administering the consumable substance to the animal and the time of day of administering the consumable substance to the animal. The method may further include a step of associating the data record with the machine-readable code. 
         [0021]    An embodiment of a consumable substance according to the present invention is a substance to be absorbed by an animal digestive system, the substance comprising a code. 
         [0022]    According to another embodiment of a consumable substance according to the present invention, the code is a machine-readable code. 
         [0023]    According to still another embodiment of a consumable substance according to the present invention, the substance comprises a tablet form. 
         [0024]    According to yet another embodiment of a consumable substance according to the present invention, the code is etched into an outer surface of the tablet. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0025]      FIG. 1A  is a perspective view of a first embodiment of a container according to the present invention. 
           [0026]      FIG. 1B  is a zoomed in view of a portion of  FIG. 1A . 
           [0027]      FIG. 2  is a perspective view of a second embodiment of a container according to the present invention. 
           [0028]      FIG. 3  is a perspective view of a third embodiment of a container according to the present invention. 
           [0029]      FIG. 4  is a perspective view of a fourth embodiment of a container according to the present invention. 
           [0030]      FIG. 5  is a perspective view of a first embodiment of an in vivo consumable container according to the present invention. 
           [0031]      FIG. 6  is a perspective view of a first embodiment of an in vivo consumable substance according to the present invention. 
           [0032]      FIG. 7  is a perspective view of an embodiment of an administration or consumption environment according to the present invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0033]    Although the disclosure hereof enables those skilled in the art to practice the invention, the embodiments described merely exemplify the invention which may be embodied in other ways. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims. 
         [0034]    Turning now to the figures,  FIGS. 1A and 1B  depict a first embodiment  100  of a container according to the present invention. The container  100  generally includes a syringe body  102  extending longitudinally between and including a distal end  104  and a proximal end  106 . Disposed at the distal end  104  may be a tip  108 , which may include a hypodermic needle to be inserted into a human or other animal, an irrigation tip, or a coupling (e.g. Luer lock or fitting) to be coupled to another device (such as a syringe body  102  formed as a pre-filled syringe cartridge adapted to be coupled to a mating interface, such as a needle or irrigation tip (not shown)). The syringe body  102  further includes a barrel  110  disposed between the distal end  104  and the proximal end  106 . The barrel  110  is adapted to contain a substance  112  to be forced or extracted through the tip  108 . Situated at least partially within the barrel  110  may be a plunger  114  extending from a proximal end  116  disposed outside the barrel  110  to a distal end  118  disposed within the barrel  110 . The plunger  114  may extend into the barrel  110  through an open proximal end  120  thereof. At least partially surrounding a portion of the barrel  110  may be a dispensing support structure, such as a flange  122  radially extending from the barrel  110  and longitudinally disposed closer to the proximal end  106  of the syringe body  102  than to the distal end  104  of the syringe body  102 . The flange  122  preferably has opposing proximal  122   a  and distal  122   b  surfaces. 
         [0035]    The syringe body  102  is preferably formed of a unitary, one-piece construction, such as by being injection molded. The body  102  (or any portion of a container on which a code  150  is placed) may be composed essentially of or include plastic (e.g., polyvinyl chloride (PVC), polypropylene, ethylene vinyl acetate (EVA or EVAM), polyester, copolyester, cyclic olefin polymer or copolymer (COP or COC), polyvinylidene fluoride (PVDF), polycarbonate, or any other plastic resin), metal (copper, aluminum, steel, nickel, gold, platinum), and/or glass. 
         [0036]    Disposed preferably on an outer surface of the syringe body  102  or the plunger  114  is a code  150 . Although ink could be used to apply the code  150  (e.g., the code  150  could be printed), the code  150  is preferably indelibly etched into the material of the container  100 . Etching may be done with a laser, or a chemical mask process such as photoetching. In the case of an etched code, then, the underlying substrate (e.g., syringe body  102  or plunger  114 ) actually forms the code, having been altered by a laser or chemical, for example. The code  150  may be any code but is preferably a machine readable code (i.e., any technology that conveys information linked to a container or substance in a form that can be entered into an electronic record, such as a patient record, or other computer system via an automated process), such as a linear (1-dimensional) barcode (e.g., a universal product code (UPC)), or a matrix (2-dimensional) barcode (e.g., a quick response (QR) code), the latter being most preferred. Examples of preferred codes may be found in U.S. Pat. No. 8,651,385, issued to Prpa, which is incorporated by reference herein in its entirety. The code  150  preferably includes a code length  152  and a code width  154 , each of which may be between about one millimeter and about 30 millimeters. Most preferably, the code length  152  and code width  154  are substantially equal to form a QR code of about one millimeter by about one millimeter to about 5 millimeters by about 5 millimeters. In addition to the machine readable code, human readable plain-text may be provided for the same or similar purposes. The code may be issued under a standardized system, such as a system operated by a regulatory agency (e.g., U.S. Food and Drug Administration), and may conform to international standards, such as those promulgated by the International Organization for Standardization (ISO), namely ISO/IEC 15459-2 (Unique identifiers: Registration procedures), -4 (Unique identifiers: Individual items), and -6 (Unique identifier for product groupings), and ISO/IEC 646 (ISO 7-bit coded character set for information exchange). An example of such code may be a code assigned, issued, and/or defined by a governing or oversight body (e.g., a unique device identifier (UDI) as defined by the U.S. Food and Drug Administration) or similar code meeting substantially similar or identical formalities. 
         [0037]      FIG. 2  is a perspective view of a second embodiment  200  of a container according to the present invention, where like numerals represent at least substantially similar or identical structure to the first embodiment  100 . In this embodiment  200 , the code  250  is placed on or etched into the plunger  214 , such as by being etched into the proximal end  216  thereof. 
         [0038]      FIG. 3  depicts a representative embodiment  300  of a container or carrier, such as a transdermal patch. Within the patch  300  may be a substance intended to be delivered transcutaneously, such as testosterone, nicotine, cannabinoids, analgesic, contraceptive, nitroglycerin, or local anesthetic. The patch  300  includes a code  350  according to the present invention. 
         [0039]      FIG. 4  shows another embodiment  400  of a container, a gravity feeding bag, according to the present invention. This type of container  400  may contain a fluid to be delivered intravenously. The fluid may be a simple saline solution or a complex nutrition cocktail, for example. Other fluid may include blood, opiates, opioids, non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., acetaminophen, ibuprofen, naproxen sodium), antidepressants, diuretics, insulin, anticoagulants, steroids, adrenaline, antihistamines, coagulation modifiers, radiologic agents, etc. The container  400  includes a code  450  according to the present invention. 
         [0040]    Not only can embodiments of the present invention be used in conjunction with containers that remain ex vivo before, during and after administration of a substance contained therein,  FIG. 5  depicts an embodiment  500  of a container to be consumed in vivo, such as by being swallowed. This container  500  is a capsule  502 , such as a gelatin or plant-derived capsule, which may contain a medicine, vitamin, or food supplement, for example. The capsule  502  may have a first half  504  and a second half  506  of conventional manufacture, generally assembled along a longitudinal axis  508 . Not of conventional capsule manufacture, however, is a code  550  provided on one or each half. The capsule  502  may be of any desirable size, such as size 000 (about 26 millimeters long) to size 5 (about 11 millimeters long). In any event, the code has a length  552  along the longitudinal axis  508  that is about 5% to about 20% of the entire capsule length. 
         [0041]    Further, instead of a container being marked, an in vivo consumable composition itself may be coded, such as that shown in  FIG. 6 .  FIG. 6  depicts an embodiment  600  of a consumable, digestable substance in the form of a tablet  602 , which may be formed by compression of a granulated material, such as a pharmaceutical material intended to be absorbed by an animal digestive system, by a conventional tablet press. The tablet  602  preferably has a substantially or completely homogenous cross section of material. Alternatively, a pressed tablet may be sealed and/or coated and/or polished. After or during pressing, the code  650  may be applied to or etched into the tablet  602 . A further material that may be coded according to the present invention is ingestible film, such as that disclosed in U.S. Pat. No. 7,357,891, issued to Yang et al., and incorporated herein by reference in its entirety. 
         [0042]    A code (e.g.  150 ) according to the present invention may include encoded information about a substance to be taken in vivo. The code is preferably an indelible marking on the container or the substance, and preferably applied without ink, such as by laser etching. The code may be encoded with information related to the substance itself, such as a brand name, generic name, National Drug Code (NDC) number, ingredients, amount/quantity of substance (e.g., volume or mass), possible side effects, indications, contraindications, and/or appearance (e.g., round white tablet, chalky pink liquid, etc.), or any combination thereof. Encoded information may also or alternatively relate to manufacturing and/or storage of the substance, including a manufacturer&#39;s lot number, production date, production time of day, and/or expiration date, or any combination thereof. If the code is placed on a container, the code may include encoded information related to the container itself, including capacity, type (e.g., syringe, IV bag, transdermal patch, single serve sealed cup or pouch), manufacturing and/or storage of the container, including manufacturer&#39;s lot number, container serial number, production date, production time of day, expiration date, and/or compatible contents, or any combination thereof. The code may additionally or alternatively include encoded information related to a particular natural or juristic person, such as a prescribing physician, pharmacist, administering physician, patient, insurance company, and/or consumer, or any combination thereof. Information related to a particular person may be name, postal address, telephone number, e-mail address, health insurance company name, health insurance policy number, social security number or other government issued identifier, credit card information or other payment account information, birth date, and/or age, prescribed or allowed dosage amount, prescribed or allowed dosage schedule, or any combination thereof. 
         [0043]      FIG. 7  is a perspective view of an administration environment  700  in which embodiments of devices according to the present invention may be used. Such environment may be a hospital patient room, operating room, cafeteria, restroom, pharmacy, doctor&#39;s office, etc. The embodiment shown includes an environment in which medication may be administered to a patient  702 . The environment may or may not include a sterile field. The patient  702  may be conscious or unconscious, but generally is to be provided with some substance to be taken in vivo, whether orally, intravenously, transcutaneously, or percutaneously. In the environment  700  is preferably a scanner  704 , which may be used in accordance with the present invention. The scanner  704  may be any scanner adapted and configured to read a code (e.g.  150 ) and deliver an electronic representation of the code to a computer  706 , which may be connected to a network, such as a local area network (LAN), wireless local area network (WLAN), wide area network (WAN), and/or a global computer network, such as the Internet. The scanner  704  may be a laser barcode reader or an image-based barcode reader, for example, which may be handheld or securely disposed within a housing. The computer  706  preferably includes or is communicatively coupled to a display  708  and may further include a speaker or buzzer (not shown) for providing feedback to a user. 
         [0044]    A method of substance (e.g., food and/or drug) administration control or verification according to the present invention includes, in an administration environment (e.g.,  700 ) including an animal (e.g., human, feline, canine, livestock) to receive the substance, receiving a container (e.g.,  100 ) including a code (e.g.,  150 ) disposed thereon and containing the substance (e.g.,  112 ), scanning the code with a scanner (e.g.,  704 ), and delivering the substance to the animal. The delivery of the substance may be direct insertion of the substance into the body of the animal (e.g., intravenous injection), or handing the container (e.g., a capsule  500 ) or the substance (e.g., a tablet  600 ) to the animal for oral consumption. The method may further include the step of, after scanning the code with the scanner, receiving feedback either directly from the scanner or from an electronic device (e.g., a computer  706 ) in communication with the scanner. The feedback may be negative feedback (indicating that the delivery step should not occur at this time) or positive feedback (indicating that the delivery step should be performed at this time). The method may then proceed with the delivery step, preferably only if the feedback was positive feedback, thus including the step of withholding the substance from the animal if the feedback is negative feedback. The method may further include a step of scanning the container after the delivery step, which may indicate that the delivery is complete. Prior to or after (but substantially contemporaneous with) each scanning step, a substance administrator (e.g., nurse, doctor, animal itself) may be required to identify itself by entering a password or personal identification number (PIN) into the computer. 
         [0045]    A data record is preferably created as a result of each scanning step. The data record preferably includes an association of the information encoded by the code along with a date and a time of day, reflecting the date and time of the scanning step. The data record may be static (i.e., automatically generated with a timestamp and/or location stamp), or a user may be prompted for data entry related to the scan. For instance, a user may be prompted to enter a purpose for the scan or a purpose may be automatically entered based on the location of the scanner. Scan purposes may include LOCATION LOG, IDENTIFICATION, RX FILL, ADMINISTRATION, ADMINISTRATION START, ADMINISTRATION END, or DISPOSAL, for example. A LOCATION LOG purpose may be selected (manually or automatically) if the purpose of the scan is simply to log the location (e.g., in a database) of the scanned container or substance, such as a geographic location tracked by GPS coordinates, a location indicated by postal address, floor number, room number, or even a location along a manufacturing line. An IDENTIFICATION purpose may be selected (manually or automatically) if the purpose of the scan is to identify the container and/or substance, in which case information related to the container and/or substance may be supplied to a user after a query is made to a database. An RX FILL purpose may be selected (manually or automatically) if the purpose of the scan is to log a location and/or timestamp of setting the container and/or substance aside for a particular patient, or for dispensing the container and/or substance from a pharmacy or other storage location. An ADMINISTRATION purpose may be selected (manually or automatically) if the purpose of the scan is to verify the propriety of administering or providing the substance to a patient and/or for logging at least an approximate location and/or timestamp of such administration. ADMINISTRATION START and END purposes may be selected (manually or automatically) when a container is scanned at or near the time a substance is started and stopped, respectively, from being administered to a patient. Such purposes may include an indication of the propriety of the administration and/or for logging an at least approximate location and/or at least approximate timestamps of starting and stopping such administration. While ADMINISTRATION START and END purposes may be used at a single point of administration (e.g., when a substance is delivered and placed in vivo within a short time (a few seconds to a few minutes) after the scan), they may prove more useful when the substance is administered from the container over a longer period of time, such as through a drip IV. A DISPOSAL purpose may be selected (manually or automatically) if the purpose of the scan is to indicate that the container and/or substance is being disposed of, such as by being placed in a sharps container, in the trash, or in an incinerator, for example, and is not to be taken in vivo. The purposes may not be mutually exclusive. That is, for an ADMINISTRATION purpose, a query may first be made to a database to identify what the container and/or substance was previously 
         [0046]    The code (e.g.  150 ) may be used in an environment other than the administration environment  700 , so as to track a particular container or substance. For instance, the code may be scanned, and a data record created, in a pharmacy, food kitchen, manufacturing plant (possibly at multiple inspection locations), dispensary, etc. 
         [0047]    There are several uses for coded containers and/or substances. One method, as described above, is for substance administration control, verification and/or confirmation. Another method according to the present invention may be an invoicing method. Such invoicing method may include steps of accessing a data record resulting from a scanning step (as described above) and generating an invoice or an invoice line item including a description of the substance and a respective price, to streamline a billing process. Inventory management may be another method using containers and/or substances marked according to the present invention. 
         [0048]    Another method according to the present invention includes verification by and/or control of a dispensing machine in a manufacturing environment in which containers (i.e., syringes, syringe cartridges, capsules, IV bags, etc.) are filled. For example, syringes intended to receive a predetermined dose of a predetermined substance may be marked with a code as described herein. Such marked syringes may be presented to a manufacturing line individually or in bulk, such as through a hopper, and oriented to receive the predetermined substance. Prior to the syringe barrel receiving the substance, the code on the syringe may be scanned and the encoded information used to determine which substance and the amount of that substance to place in the syringe. This information may be used in selecting a substance from a plurality of potential substances loaded into such dispensing machine, where the selected substance matches a substance identified by the code scan. 
         [0049]    Additionally, a container of the substance loaded into the dispensing machine may also include a code. The syringe may then be filled if the encoded information indicates that the type of substance loaded into the dispensing machine is appropriate, or prevented from being filled if the substance is not appropriate. Thus, a fill/no-fill determination may be automatically made by a dispensing machine (which includes a computer including or communicating with a scanner (e.g.  704 )) based on a comparison of information encoded in a scanned code on a syringe to information related to the substance loaded into, and ready for dispensing from, a dispensing machine. This comparison may be made between information obtained or related to the scanned code and information independently maintained or accessible to the dispensing machine. The information independently maintained by or accessible to the dispensing machine may be manually entered into a database or data field accessible by the dispensing machine, or may be automatically accessed after a scan is made of a bulk container code. While it is preferred that at least a portion of the information associated with each of the syringe code and the bulk container code match (e.g., substance identification), it is not necessary for all encoded information related to the two codes match to proceed with filling. 
         [0050]    The foregoing is illustrative only of the principles of embodiments according to the present invention. Modifications and changes will readily occur to those skilled in the art, so it is not desired to limit the invention to the exact disclosure herein provided. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.