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[0001] This Application is a continuation in part of PCT Application No. PCT/US01/42563 filed Oct. 9, 2001, and claims the priority thereof, and further claims the benefit of: U.S. Provisional Application Serial No. 60/323,514 filed Sep. 19, 2001, U.S. Provisional Application Serial No. 60/326,265 filed Oct. 1, 2001, U.S. Provisional Application Serial No. 60/328,661 filed Oct. 11, 2001, U.S. Provisional Application Serial No. 60/330,112 filed Oct. 17, 2001, U.S. Provisional Application Serial No. 60/341,633 filed Dec. 18, 2001, U.S. Provisional Application Serial No. 60/351,266 filed Jan. 23, 2002, U.S. Provisional Application Serial No. 60/352,901 filed Jan. 30, 2002, and U.S. Provisional Application Serial No. 60/359,558 filed Feb. 22, 2002.
[0002] The present invention relates to medical apparatus and method, and in particular, to an assistance and tracking apparatus and method employing smart tags.
[0003] Typically, shipping and/or receiving and/or dispensing and/or using articles utilizes paper documents such as prescriptions, medical orders, bills of lading and manifests and/or paper labels that relate the objects being shipped or transported to their owner or to the designated or authorized recipient. Such documents and labels often include a bar code for automatic reading by an optical scanner that is in line-of-sight communication with the bar code. In such operations there is usually a desire to maintain a complete, accurate and up to date record of the objects shipped and received. Automated or automatic methods of providing such record are desirable, however, conventional methods all have shortcomings that result in less than the desired tracking and record being provided.
[0004] Labels applied to the objects were an attempt to afford relative automated record keeping, but tended to be cumbersome to use and error prone. More sophisticated automatic methods employed bar-coded labels and/or magnetic stripe tags, each with suitable readers. While the cost of such labels and cards is low, so is the information that can be embedded or coded in either of these media, even where complex bar codes such as a 2-D bar code is employed. In addition, most bar code readers are read-only devices that can only read the information stored in the bar code or magnetic stripe and cannot store any additional information in the bar-code label or magnetic stripe card. In addition, bar codes and magnetic stripes cannot store sufficient information to provide the desirable features necessary without a connection to a central computer and online information system.
[0005] Moreover, bar-code media require a “line-of-sight” communication path between device and reader, and magnetic stripe media require a direct or close contact communication path between device and reader at a suitable “swiping speed,” and the reliability of correct reading is about 80-90%, as anyone who has gone through a store check-out bar-code reader or a magnetic stripe credit card reader will recognize. Repeated passes of the object in front of the bar-code reader or swipes of the card reader create delay and annoyance and/or can produce record errors. Such problems are not overcome with more complex bar codes, and could be exacerbated where the bar code elements are smaller in size and thus more sensitive to smudging and dirt.
[0006] Electronic tracking using radio frequency identification (RFID) tags is one way to overcome the disadvantages of the prior art bar-code and magnetic stripe approaches. Prior art systems typically do not track the articles to be tracked along the processing path and/or do not have reliable, essentially 100% correct reader performance, essentially without the need for human intervention, as is desirable for providing complete and accurate records.
[0007] In a medical environment, errors in the dispensing, administration and prescribing of medications and medical treatments have resulted in an unacceptably large number of adverse reactions, including many deaths and permanent impairments and disability. Various estimates of the consequences thereof include tens of thousands of patients affected and annual costs exceeding $3-billion U.S. dollars. Published material reports 770,000 injuries caused by medication errors over a two-year period and an estimated 44,000 to 98,000 fatal incidences arising therefrom with a total cost of $177 billion for hospital care and long-term care. The costs created by counterfeit drugs that are ineffective, contain no or incorrect active ingredients, or the incorrect amounts or proportions of active ingredients make the problem worse.
[0008] Bar-coded labels and magnetic stripe cards have not proved completely satisfactory due to the need for line-of-sight readers and significantly less than 100% reading rate. Moreover, absent a network connection to a computer, the known prior art arrangements do little more than to read the information stored in the bar code or magnetic stripe, and cannot detect errors therein, which is a particular disadvantage in relation to medication and medical devices wherein errors in dispensing and/or using the medication or device can have serious, if not fatal, consequences.
[0009] The special needs of the elderly, infirm hearing impaired and visually impaired persons is not addressed by the prior art devices. The Healthcare Insurance Portability and Accountability Act adopted in 1996 seeks to address certain aspects of this problem. Prior art devices do not address these needs, and are too costly to permit home use, e.g., for providing automatic reminders to take medication and/or to give warning when medication is taken improperly in time and/or amount.
[0010] Accordingly, there is a need for apparatus and method that can assist in the dispensing and administration of medication and/or medical treatment. Desirably, such should facilitate tracking an object at various stations and associating the object with a desired recipient. It would be advantageous if the method and system has a high correct-reading ability (e.g., near 100%), and does not require line-of-sight readers. It would also be desirable that the method and apparatus be suitable for use in a home setting, e.g., by a consumer or patient, as well as in a professional or commercial setting, e.g., in a pharmacy, hospital, nursing home or other care-giving facility.
[0011] To this end, the apparatus of the present invention comprises a tag coder for reading from and/or writing to a tag. A processor and a memory process information read from a tag to provide a reminder message based thereon by a visual and/or an audible reminder message.
[0012] The detailed description of the preferred embodiments of the present invention will be more easily and better understood when read in conjunction with the FIGURES of the Drawing which include:
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[0026] In the Drawing, where an element or feature is shown in more than one drawing figure, the same alphanumeric designation may be used to designate such element or feature in each figure, and where a closely related or modified element is shown in a figure, the same alphanumerical designation primed may be used to designate the modified element or feature. Similar elements may be shown in the same figure designated by different “dash numbers” such as X-
[0027] In general, a system and method is useful for tracking an article or object at one or more stations over a transport path and associating the article or object with a recipient or another object. A smart tag is associated with each article to be tracked, for example, by being attached to the article either directly or indirectly, e.g., to a container containing the article. A second smart tag is associated with the recipient or other object with which the first object is to be associated after passing along the transport path. Each smart tag includes at least an electronic memory coupled to an antenna by which information from the memory may be transmitted and/or information may be received and stored in the memory. Smart tag control units (readers and/or writers) and antenna arrays at various stations communicate with the smart tags and may also communicate directly or indirectly with one or more processors that process the information, for example, for monitoring and/or controlling the stations and/or control units and/or lines including one or more stations.
[0028] As used herein, the following terms are used to include but are not limited to:
[0029] “Article” and “object” and “person” are used interchangeably to refer to any article, object or other thing or person or animal to which a smart tag may be attached or with which a smart tag may be associated. Examples include, but are not limited to, packages, parcels, containers, medications, medical devices, instruments, implements, containers therefor and the like in a medical or hospital environment. A person may be an “object” in, for example, a medical environment where the apparatus and/or method is utilized for associating a person as patient with his medication, medical device, treatment and/or other procedure.
[0030] “Electronic gate” is used to refer to an antenna or array of antenna in combination with a smart tag reader/writer that communicates with a smart tag via the antenna or array, and which may also include a display, annunciator or other device for providing information in human perceivable form. The antenna or antenna array may be disposed at an entry point or other location of a station for receiving information produced from a smart tag that is within its detection region and for transmitting information to be stored in the memory of a smart tag within its detection region, or at a point of use or treatment or other location.
[0031] “Smart tag” and/or “wireless tag” and/or “RFID tag” is used to refer to an article that includes at least an electronic memory wherein information from the memory may be transmitted and/or information may be received and stored in the memory. A “wireless” type smart tag including an antenna is preferred, wherein the information is electromagnetically coupled from or to the antenna over a distance or range. However, a “contact” type smart tag, wherein the information is electrically coupled through physical electrical connections made to contacts on the smart tag, may also be utilized, although it is less convenient.
[0032] “Station” is used to refer to any dispensing location, treatment location, point of use, booth, station, gate, portal, check-in position, article claim, check point, manufacturing or processing location, ramp, conveyor, conveyance, shipping area, receiving area, and the like that one or more objects may be at or pass at which a smart tag may be issued, read, written to, and/or collected.
[0033] “Transport path” is used to refer to any path, route, conveyor, conveyance, carriage or other means or combination of means by which an object, article or person may move or be moved from one place to another.
[0034] The process of
[0035] In a hospital, clinic, pharmacy, nursing home or other medical facility or environment, the tracked object may be medication, medicine, a medical device and/or implement and the like, and the check object may be a prescription, written order, patient chart and/or patient identification band and the like.
[0036] The information stored in the memory of each smart tag when issued
[0037] The tracked object is tracked
[0038] The check object is tracked
[0039] Tracking and monitoring movement of the object smart tags and check smart tags may be accomplished in several different ways. Each tracking
[0040] Alternatively and/or additionally, and optionally, such tracking information can be communicated along with smart tag identifying information to a processor and stored in a relational database for easy and quick reference and access as needed or desired, as described below. Further, and also alternatively and/or additionally, and optionally, such tracking information and tag identity information can be stored in the smart tag reader associated with each electronic gate at which tracking
[0041] The tracked object and the checked object are associated
[0042] If a match
[0043] If a match
[0044] Alternatively and/or additionally, and optionally, if a match
[0045] Considering
[0046] The object smart tag is encoded to contain, for example, a serial number or other smart tag identifier, the identity of the medication and/or medical device, quantity and dosage, frequency and conditions of use, manufacturer and/or provider, expiration date, and the identity and particulars of the implement, procedure and/or treatment with which the object smart tag is associated or affixed. A paper label containing the same information as is stored in the object smart tag may also be issued and affixed to or associated with the medication, medical device, implement, procedure and/or treatment.
[0047] When a doctor, physician or other personnel writes a prescription, referral, script or other order for medication and/or medical device, a procedure and/or treatment, he utilizes a device that issues a check smart tag that is affixed to an otherwise conventional paper document. Encoded in the check smart tag is information such as, for example, a serial number or other smart tag identifier, the identity of the medication, medical device, implement, procedure and/or treatment, dosage, form and frequency of administration information, refill and repetition information, issue and/or expiration dates, the patient's name and other patient information, the name of the physician or other person writing the order, and/or the diagnosis or sickness or condition. The paper document preferably contains the same information in human-readable form
[0048] The medication, medical device, implement, procedure and/or treatment with the object smart tag associated or affixed is transported
[0049] At the destination, the patient and his check smart tag are associated
[0050] In the case of no match
[0051] It is noted that the transport paths
[0052] For example, where the disease or condition is encoded in the check smart tag, and the relational database includes or is linked to a medical information database that includes medication and/or medical device, treatment and effectiveness information, then medical personnel are provided an indication of whether that prescribed is a functionally useful treatment such as a specific medication, or is useful as a supplement such as a vitamin or mineral or herb, or is functionally neutral or is functionally adverse or contraindicated. Such databases of medications and/or treatments are available and may be linked to the relational database utilized for searching
[0053] A significant advantage of such arrangement is the reduction of mis-prescribing and inappropriate and/or unnecessary treatment, or other human-errors due to an alarm or alert being provided. Likewise, drug interactions, adverse reactions and allergies are avoided. It is noted that such medical relational database can be coupled to the smart tag issuing
[0054] In addition, at reading
[0055] Thus it is evident that the same system elements may be configured to provide an apparatus and/or method in any one of many types of environments, facilities, locations, functions and operations. One example thereof is a facility, typically a centralized facility, at which large numbers of prescriptions for medicine, medical devices and the like are ordered via telephone and/or computer and are then filled and are dispensed via the mail or a delivery service. Typically such facility is operated by a pharmaceutical company or distributor contracting with a health insurance provider for providing medication and/or devices for treating long term and/or chronic conditions.
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[0057] Because the object smart tags and check smart tags are the same functionally except for the information stored therein, and the various stations (electronic gates) are the same functionally, the system operates with both object and check smart tags in the same manner, i.e. reading and writing data from and to the smart tags
[0058] As the issued object smart tag
[0059] Separately, as the issued check smart tag
[0060] When the object and object smart tag
[0061] Where an object and check do not become properly associated at a destination, one or the other is at the wrong destination, and a search can be conducted by processor CP relating the records of the relational database therein pertaining to the particular object smart tag
[0062] Moreover, such tangible record may be any one or more of a printed document, a computer floppy disk, a computer CD-ROM disk, or any other desired medium Where the tangible record is a computer readable medium, such as a floppy disk or a CD-ROM disk, the medium, the computer readable files thereon may include files directing access to either a central web site or to particular web sites at which further information may be accessed and/or retrieved. Such record may be provided to personnel seeking to find and match up the missing object or check or to the owner, shipper or recipient thereof, or other person, as may be desirable and appropriate.
[0063] While only one processor (computer) is necessary to the system
[0064] Communication between the registration station RS, the various tracking stations
[0065] Communication may occur periodically, but promptly (e.g., within seconds or minutes) relative to the speed and frequency of passing of the objects in transport and the time and date thereof, and the timeliness of tracking and monitoring desired. Communication may be periodic, but less frequent, regarding the status of a station
[0066] Suitable communication devices are available commercially from several sources and provide direct communication or communication via relay links. Such devices are suitable for communication between computers over local area and wide area networks and may employ CDMA and/or spread spectrum communication techniques. For example, RF communication devices available from Proxim, Inc., located in Sunnyvale, Calif., include, for example, a RangeLAN2 system operating at 2.4 GHZ, a Stratum Building-to-Building system, and a Symphony Home and Small Office system Such devices transmit and receive information and programming changes between and among central processor CP and local computers and/or control units
[0067] Where information is written to and stored in smart tag
[0068]
[0069] Preferably, smart tag reader
[0070] As described herein, the antenna
[0071] Smart tag
[0072] The coding provided by processor
[0073] Information including related information from smart tag
[0074] Optionally, electronic gate
[0075] Display
[0076] Personnel may enter information requests and the like, i.e. requests for data items or specific records, via input means
[0077] Also optionally, a printer to paper, or an electronic writing device that provides the information on other tangible media, such as floppy disks, CDs and other electronic media, may be associated with a particular station
[0078] Alternatively, display
[0079] Smart tags
[0080] For the present smart tagging system and method, an electronic integrated circuit in the form of a semiconductor chip is connected to an antenna ANT on a substrate to serve as a tag. The semiconductor chip typically includes a processor and an electronic memory for storing information. Information stored in a smart tag can be read by a suitable smart tag reader and can be read and written to by a suitable reader/writer. The reader or reader/writer and the tag antenna are tuned suitably so that RF energy (electromagnetic fields and electrical signals) can stimulate the tag to emit a signal representative of the information (electronic codes or data) stored ill the tag memory. Such contact-less RF tags eliminate the need for an electrical contact or a line-of-sight path for communication with the smart tag.
[0081] Suitable smart card/smart tag semiconductor chips include the I-CODE chip and the MIFARE chip, both available from Philips Semiconductors located in Eindhoven, The Netherlands, and the types SLE4442 or SLE4428 memory ICs available from Siemens of Germany. Also suitable are the “Tag-it” devices available from Texas Instruments of Dallas, Tex., the “Pico-Tag” devices available from Inside Technology of France, and devices available from Microchips of Phoenix, Ariz. Each smart tag/semiconductor chip must have sufficient memory for storing all of the information desired to be stored therein. Typically about 100-500 bytes is sufficient, one kilobyte or 1000 characters is preferred, and 2000 bytes or characters is better.
[0082] Suitable smart tags include those, such as an I-code chip, that conform to the ISO15693 format protocol for wireless RF identification tags, as is available from several commercial sources. Smart tags may also include an overwrite protection feature whereby information stored therein may be protected from being overwritten or changed, thereby to provide a measure of security.
[0083] Suitable smart tag reader/writers include those available from Avante International Technology, Inc. located in Princeton Junction, N.J., the Fast-Track system available from Escort Memory Systems located in California, the Interrogator Control Module available from Samsys Technologies, Inc. located in California, and the Memor 2000 RFID available from Minec company located in Taby, Sweden, as well as readers/writers available from Intermec Technologies Corporation located in Everett, Wash., Fargo Electronics, Inc. located in Eden Prairie, Minn., or from Atlantek, Inc. located in Wakefield, R.I.
[0084] Suitable processors (both local processor LC and central processor
[0085] Applications programs suitable for recording and manipulating the information include relational database software such as the Windows-NT-based Microsoft ACCESS database as well as ORACLE, SYBASE and INFORMIX database software, and software languages such as Visual Basic, Java, or other language compliant with American National Standards Institute (ANSI) Standard 256. Each database record will typically include fields some or all of the following information: The article identification and/or serial number and/or quantity, station and/or operation identification, entry and exit time data (arriving and leaving), date, bill of material data, actual/planned material usage, keypad/keyboard entered data, component/part/material smart tag information, operator/employee/individual smart tag information, quality control and inspection data, transport provider, and the like. Thus, the database maintains an inventory of the articles, their quantities and locations and may be utilized to categorize the data contained in the database records for tracking any article or any type or group of articles, and/or any station so also provide status and inventory by station, operator or any other desired category of the stored records. Typically, the database software interfaces with other standard software, such as the standard MRPII software available from the Great Plains division of Microsoft Corporation of Redmond, Wash.
[0086] Desirably, processed information and/or transactional information should be available in human readable form, such as by display on a computer monitor or by print out by a computer printer, both of which may be conventional. Where certain information recorded and/or processed is representative of parameters or conditions that may pose a hazard to personel or property, or are critical to an operation or process, or indicate a failure of some test or condition, it is desirable to include an alarm, such as a loudspeaker, flashing light, buzzer, speech synthesizer, or the like, that is activated automatically by an out-of-limit or marginal condition.
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[0088] Manufacturers of the electronic devices or chips utilized in smart tags typically segment the memory thereof into two segments: a first segment
[0089] Smart tags
[0090] While it is satisfactory to utilize only the stored permanent number identifier
[0091] One potential problem associated with such smart tags occurs where the information desire to be stored therein is simply coded and written into the writeable memory
[0092] To reduce the likelihood of undetected erroneous stored information, the remaining memory
[0093] Where the smart tag includes processing capability, the processor can be programmed to calculate the relational check number upon each time data is written to its memory, preferably upon command to do so. Alternatively or additionally, each reader/writer or an associated processor or central processor can calculate the relational check number. Because the electronic device utilized in a smart tag has substantial memory capacity, the relational check number can include many bits and so can be constructed to permit error correction as well as error detection.
[0094] The foregoing arrangement permits detection of errors and/or changes to the application specific data at any time by reading the card and recalculating the relational check number which is then compared to the relational check number read from the smart tag. If the read and calculated relational check numbers match, then there is a high degree of certainty that the application specific data has not been changed and does not include errors.
[0095] It is noted that while the permanent number, the application specific data and the relational check number or code are referred to as “numbers,” each may include numerical, alphabetic, alpha-numeric and other characters and symbols, conventional or arbitrary, as may be desired. The relational check number or code is representative of the information stored in the memory in accordance with a predetermined formula or algorithm or other scheme, either on a character by character basis or on the basis of one or more combinations of the characters or values stored in the memory. Suitable formula and algorithms include, for example, parity checks or other parity representations, sum checks, field relationship checks or any other predetermined relationship between the stored permanent number and application specific data values and the relational check number.
[0096] Thus, any change to the stored information, including a change that changes the stored value of the relational check number or code, will be detectable and an indication that the stored data contains one or more errors or changes. Typically, the particular formula or algorithm that generates the relational check number is not known to third parties and is not derivable from the data stored in the smart tag memory, and so the relational check number provides a degree of security for the information stored in the smart tags.
[0097] The formula or other algorithm or other encoder for generating the relational check code or number may be provided in protected firmware, in software or in a combination of firmware and software, to provide a higher level of security against deciphering or unauthorized coding. For additional security, each encoder may also include a unique identifier that must be paired with coding software having the same unique identifier for enabling proper functioning. The unique encoder identifier may also be included in or as part of the application specific data.
[0098]
[0099] In a complete database, database
[0100] In a simplified database, database
[0101] Suitable relational database software include ACCESS and SQL Server database software which runs on conventional PC processors with standard operating systems, such as Windows-NT, both available from Microsoft Corporation of Redmond, Wash., as well as the ORACLE, SYBASE and INFORMIX database software. Preferably the database software is “Internet-ready” in that it includes features facilitating connection to and communication of information via the Internet.
[0102] Each database record will typically include fields for some or all of the following application specific data or information in addition to the permanent number:
[0103] Object information including but not limited to the identification of the object, its manufacturer, its dispenser and/or shipper, its patient and/or recipient, the identification of the mode of, time of, dosage of and/or frequency of administration, conditions of use, refill and expiration information, and/or other identifying information, and the like.
[0104] Station information including but not limited to station identification, operator/personnel identification, entry and exit time data (arriving and leaving), date, expiration date, keypad/keyboard entered data, smart tag information, quality control/inspection information, and the like.
[0105] Relational check number representative of any or all of the foregoing application specific data and/or the permanent number of the smart tag.
[0106] Where the information written to each smart tag is all communicated to and stored in a central database and where all subsequent action to be taken will be taken based upon the information stored in the central database, then the use of a relational check number to verify the information stored in the smart tag and/or detect errors in and changes thereto is of much less importance.
[0107] In any case, the central database can be utilized to provide particular information, general information, status information, statistical information, and other information on an on-line basis that is at least as current as the entry of record information into the database. Where every writing of information to a smart tag is also replicated in a record stored in the relational database, the relational database contains and can provide a detailed history of the utilization of the smart tag, e.g., the path of the object's movement and the date and time of its passing each station as well as information entered at each such station.
[0108]
[0109] A cross check
[0110] Results of the reading of smart tags and of the correlation of the check numbers thereof are reported
[0111] A further cross check
[0112] In particular, correspondence in cross check
[0113] Initiating a human-perceivable display or alarm, or communicating information to or from another location can include liking
[0114] Further, correlation or lack of correlation or any other difference between the information read from a smart tag and the related information stored in the relational database initiates displaying
[0115] The display of the result or status of any step and/or of the information to which attention is to be drawn may be included in a display of information, e.g., such as by highlighting or coloring the portion of the displayed information to which attention is to be drawn, or by separately displaying the information to which attention is to be drawn. Where information desirable to be displayed is available in the relational database, such information is retrieved and displayed automatically, either locally, remotely or via the Internet, as appropriate. If such information is not so available, a warning or instruction to an operator is provided to instruct the operator to either retrieve the information or to segregate or mark the affected smart tag for special treatment or handling, e.g., such as alerting an attendant or operator at final or check out station when an article associated with that smart tag arrives.
[0116] It is noted that the foregoing arrangements and method also can enable the detection of changing or tampering with the information stored in the smart card for the unlikely case where the changing or tampering is done with knowledge of the calculation of the relational check number. In such case, the relational check number is correctly related to the application specific data and/or the permanent number and so the simple cross checking
[0117] Where desired, the relational database may be accessed and made available by any convenient means, e.g., by providing same on floppy disk or CD-ROM, optical CD and the like that is easily sent by mail, express and the like, or by making same available via communication means such as wire, cable, optical fiber, LAN, WAN, optical or radio frequency transmission, the Internet and the like.
[0118]
[0119] The encoded application specific data and relational check number read from the smart tag are decoded and separated
[0120] If the two check numbers correlate (i.e. match, path “Y”), then there is a high degree of confidence that the application specific data does not contain errors and has not been altered, and the application specific data is displayed
[0121] If there is a non-correlation (i.e. non-match, path “N”) or other discrepancy, such non-correlation or discrepancy produces the display of a warning or alarm
[0122] Whether there is correlation or non-correlation of the relational check number, a record is stored
[0123]
[0124] Medication is provided, for example, in bulk or quantity in a container referred to as a “master” container
[0125] In addition, plural smart tags