WO2001046016A1 - Systeme et procede de posologie personnalisee - Google Patents

Systeme et procede de posologie personnalisee Download PDF

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Publication number
WO2001046016A1
WO2001046016A1 PCT/US2000/035048 US0035048W WO0146016A1 WO 2001046016 A1 WO2001046016 A1 WO 2001046016A1 US 0035048 W US0035048 W US 0035048W WO 0146016 A1 WO0146016 A1 WO 0146016A1
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WO
WIPO (PCT)
Prior art keywords
pill
doses
dose
bins
recited
Prior art date
Application number
PCT/US2000/035048
Other languages
English (en)
Inventor
Rodger H. Rast
Original Assignee
Rast Rodger H
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Rast Rodger H filed Critical Rast Rodger H
Priority to EP00993502A priority Critical patent/EP1220781A4/fr
Priority to AU54411/01A priority patent/AU5441101A/en
Publication of WO2001046016A1 publication Critical patent/WO2001046016A1/fr
Priority to US10/009,041 priority patent/US20030200726A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0076—Medicament distribution means
    • A61J7/0084—Medicament distribution means for multiple medicaments
    • G—PHYSICS
    • G05—CONTROLLING; REGULATING
    • G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
    • G05B19/00—Programme-control systems
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/08—Logistics, e.g. warehousing, loading or distribution; Inventory or stock management
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06V—IMAGE OR VIDEO RECOGNITION OR UNDERSTANDING
    • G06V20/00—Scenes; Scene-specific elements
    • G06V20/60—Type of objects
    • G06V20/66—Trinkets, e.g. shirt buttons or jewellery items
    • G—PHYSICS
    • G07—CHECKING-DEVICES
    • G07F—COIN-FREED OR LIKE APPARATUS
    • G07F17/00—Coin-freed apparatus for hiring articles; Coin-freed facilities or services
    • G07F17/0092—Coin-freed apparatus for hiring articles; Coin-freed facilities or services for assembling and dispensing of pharmaceutical articles
    • G—PHYSICS
    • G07—CHECKING-DEVICES
    • G07F—COIN-FREED OR LIKE APPARATUS
    • G07F5/00—Coin-actuated mechanisms; Interlocks
    • G07F5/18—Coin-actuated mechanisms; Interlocks specially adapted for controlling several coin-freed apparatus from one place
    • G—PHYSICS
    • G07—CHECKING-DEVICES
    • G07F—COIN-FREED OR LIKE APPARATUS
    • G07F9/00—Details other than those peculiar to special kinds or types of apparatus
    • G07F9/002—Vending machines being part of a centrally controlled network of vending machines
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/13—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered from dispensers
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H70/00—ICT specially adapted for the handling or processing of medical references
    • G16H70/40—ICT specially adapted for the handling or processing of medical references relating to drugs, e.g. their side effects or intended usage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A61J1/035—Blister-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2205/00—General identification or selection means
    • A61J2205/30—Printed labels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers

Definitions

  • the burden can be somewhat alleviated by the use of a pill container having compartments for storing collections of pills so that one can collect up to a weeks worth of doses at a time.
  • segmented containers remain inconvenient, and are difficult to take to work or when traveling light, such as on an overnight business trip.
  • the consumer needs to manage their inventory of medications and supplements; ordering or purchasing each as necessary. It will be recognized that the containers of pills will typically be depleted at different times, leaving the consumer in the position of continuously purchasing replacements for one or more of the supplements or medications. Additional problems exist with the current manner of dispensing these supplements and medications. The consumer needs to keep track of times at which doses are to be taken. Of course the consumer must remember to take each of the doses.
  • miss-dosing is very prevalent amongst senior citizens, especially the millions suffering from memory loss, or Alzheimers disease. The prevalence of miss- dosing can be inferred from the numerous devices that have been marketed and/or patented, that attempt to meter out pills or record when pills are taken by an pill consumer.
  • Institutional care organizations such as hospitals, nursing homes, and the like, suffer from another set of problems associated with providing doses of supplements and medications to their patients.
  • Institutions have a staff which maintains the various supplements and medications; often doling them out to patients and supervising their taking of the pills for each dose.
  • the overhead and liability associated with creating and supervising these numerous doses each day for every patient becomes exceedingly costly and prone to error.
  • the inventory of supplements and medications must be carefully managed, assuring adequate supplies, proper storage conditions, proper dispensing conditions, and assuring that expiration dates are taken into account. Care staffs need to remain vigilant to be certain that each patient gets the proper doses, and that doses created for one patient are not received by another patient.
  • the present invention is a system and a method for providing persons with individualized (custom) doses of their recurrent supplements and medications.
  • Dose was derived from the Greek word “dosis” which means “gift”, while the word “temporal” refers to time.
  • the right dose at the right time is a gift to the health of each individual.
  • the present system and methods may hereafter be referred to as “individualized dosing system", or simply as “system”.
  • the system comprises an interface, such as a web site on the World Wide Web, for allowing a consumer, or institution, to: establish a dosing schedule, enter a custom array of medications and supplements (MS) into the dosing schedule, and to receive individually packaged doses which are ready for use and marked with the patient name and scheduled date and time that the MS is to be taken.
  • the consumer, or institution is thereby no longer burdened by the maintenance of a miniature pharmacy while numerous concomitant safety and convenience features are provided.
  • medications and supplements (MS) comprises any variety of medical and/or health related solid, or semisolid pill, for instance, conventional pills, capsules, caplets, gelcaps, and lozenges.
  • MS used herein is inclusive of new pill packaging forms as well, since solid pill forms constantly evolve and their use within the system would be obvious. Although the present system follows the largest segment of the MS market, which is solid form MS, embodiments are additionally described for the delivery of liquid forms of MS within the system.
  • an individual consumer can interface to the individualized dosing system by way of a web site interface.
  • the consumer typically would register by establishing their identity and configuring a number of use parameters.
  • the consumer then establishes a dosing schedule on the system and populates it with MS selected from a database; the database may include MS selected from a master MS library, MS template, MS library from a recommended source, or a personal library selected as a subset of the master MS library.
  • the system generally being configured to only represent MS within the library, which is (or shall be) in stock at the time the individualized dose order is to be fulfilled.
  • Echinacea be taken following periodic dosing, wherein the herb is taken for a week or two, halted for a week or two, taken for a week or two, and so forth.
  • the system increases consumer safety by preferably performing assessments of the selected MS for possible interactions with one another.
  • the system assesses the selected MS against the profile for possible clinical contraindications for use. The consumer is alerted to possible side effects, and in some cases is urged, or even forced, to alter their selections to suit prudent medical practice.
  • the consumer may submit the order for various forms of pre-order verification; such as to their doctor, pharmacist (or other party); their insurance company to determine payments therefrom; or they may submit the order directly for fulfillment.
  • the system contains a large medication database operably connected with an ERP system that in combination directs a specialized manufacturing system containing a packetizing system that is capable of creating arrays of individualized custom patient doses for shipment to an individual, or institution.
  • the packetizing system fulfills orders for each consumer, or institution, by first creating a "dose collection array” (DCA) associated with the doses of the order to be filled with assorted MS.
  • DCA dose collection array
  • the DCA traverses a series of MS bins which are configured for controlled selective dispensing of MS.
  • the MS bins are implemented to verify that proper MS are correctly being collected.
  • the DCA is received within a packetizing station which preferably verifies the MS of the individualized doses once again prior to packaging and labeling each of the doses within the order.
  • the orders are then packaged and shipped to the consumers, or institutions, which receive an ordered set of individualized custom doses which are labeled according to the dose schedule which has been established.
  • An object of the invention is to create individualized custom doses of medications and supplements (MS).
  • Another object of the invention is to provide convenient ordering of MS in periodic quantities, such as by months.
  • Another object of the invention is to provide MS in synchronized quantities whereby an individual need not check and maintain stocks of various MS which are being depleted at different rates and times.
  • Another object of the invention is to increase the level of compliance for the taking of prescription medications.
  • Another object of the invention is to provide MS as dose packets that are labeled for the date and time they are to be taken. Another object of the invention is to provide a convenient mechanism by which one or more individual doses may be carried easily when the individual will not be at home at the time the dose is to be taken. Another object of the invention is to provide an MS dissemination mechanism wherein a patient need not remember what and how many of each supplement or medication is to be taken at each varied dose interval.
  • Another object of the invention is to provide pre-collected doses of supplements and medications such that the individual need not open containers and individually collect MS for each particular dose.
  • Another object of the invention is to provide a dose dissemination mechanism wherein doctors can order prescription medicines as doses integrated with the doses already being taken by the individual.
  • Another object of the invention is to provide a dose dissemination mechanism wherein doctors can check the supplements and over the counter medications being taken by the patient to assess possible interaction risk and contra-indications.
  • Another object of the invention is to provide a mechanism for the distribution of supplements and medications that may be used within hospitals to reduce overhead and dosage errors associated with collecting individual doses.
  • Another object of the invention is to improve cleanliness in relation to the dispensed medication.
  • Another object of the invention is to reduce the number of dosing errors and thereby increase both safety and health factors in taking supplements and medications.
  • Another object of the invention is to provide a high-speed dose fulfillment system.
  • Another object of the invention is to provide a system in which particular medications and supplements may be replenished while the dose fulfillment system is still operating.
  • FIG. 1 is flow diagram for temporal patient dosing according to the present invention, wherein individualized custom doses are scheduled and ordered over the Internet, packaged into a set of individualized doses and delivered to the consumer.
  • FIG. 4 is a side view of sealed cup form of packaging according to an aspect of the present invention, shown exemplifying use with solid pills and liquids.
  • FIG. 5 is a flowchart of an individualized dosing method according to an embodiment of the present invention shown exemplifying a customer creating individualized custom doses according to a dosing schedule.
  • FIG. 6 is a flowchart of an enhanced individualized dosing method according to an embodiment of the present invention.
  • FIG. 8 is a flowchart of individualized dosing as per FIG. 7, showing the order fulfillment process.
  • FIG. 28 is an end view of a comdav configured for operation within the tubular vehicle path of FIG. 27.
  • Each Dose packet contains the date and time the dose is to be taken, for example a series may appear as: "8:00 AM on Tuesday, Feb. 1 , 2000", “2:00 PM on Tuesday, Feb. 1 , 2000", “8:00 PM on Tuesday, Feb. 1 , 2000", “8:00 AM on Wednesday, Feb. 2, 2000",... "8:00 PM on Tuesday, Feb. 29, 2000”.
  • the packet may include additional information such as "Take with food” and any other precautions. Inserted instructions or content list may also be included within each packet.
  • the packet may contain information listing information about the supplements contained therein.
  • the string of individualized packets is boxed with any other portions of the order 34, and shipped, as represented by truck 36.
  • the order 34 arrives for the consumer 12 that contains a series of individualized doses configured by the consumer according to a dosing schedule and packaged for convenient use.
  • the consumer elects the default case wherein all doses for the month follow the same set of dose intervals, however, the user is alternatively allowed to set different time periods for each day.
  • the time periods selected are those attached to the specific dose packets, and that the individual may elect to name the doses, such as "morning” and “evening”, or “morning", "noon", and "night”.
  • the selection of a dosing schedule allows the consumer to set the name of the time period that they are comfortable with.
  • the time periods are selected by medical practitioners in accord with established facility protocols. Custom dose profile intervals may be programmed that allow the user to fit a varying dose schedule into a week or month.
  • An athlete may perhaps log on and set a new order each month based upon their training and race schedule for the following month. Typically, between two to five dose intervals are established for each day of the week. Specific MS are then selected at block 82 for use within the schedule. The selected MS is then checked in relation to the other selected MS and information about the individual, at block 84, wherein the possibility of interactions is assayed and communicated to the individual. In some cases the system preferably will require that the individual select alter one or more MS comprising the dose if a significant risk is indicated. The dose schedule is then populated at block 86 with MS that were selected in block 82 to comprise the individual doses. The individual continues entering doses, represented as the loopback at block 88, until all desired MS have been entered upon the dose schedule.
  • Suggested doses are those which would normally be suggested by a health care practitioner. Not Suggested doses are those which are not recommended by the practitioner for the particular individual. MS marked with "PersList" are retained in the short list of items pre-selected by the individual to simplify recurrent dose changes.
  • templates provide a pre-selected set of MS generally based on health parameters of the individual, such as for an individual that is hypoglycemic. After establishing their own personal library from which to select MS, the individual may enter the MS at block 132 into the schedule they have defined.
  • the important elements regarding prescriptions that are received within the system may not be changed by the individual, although they may shift specified dosing intervals as long as the changes are minor and not of consequence to treatment.
  • Processing 150 would typically be implemented on an institutional system that has been interfaced with the individualized dosing system of the present invention.
  • the medical practitioner, or clerical accesses the system at block 152 and logs on at block 154.
  • the patient whose dosing is to be entered or changed is entered in block 156. If the patient is new, as detected at block 158, additional information is entered at block 160 which is exemplified by identification information, patient location (or delivery order) information, and the medical condition of the patient.
  • the user is provided a wide assortment of choices regarding the scheduling of individualized doses, only a sample of which are shown in FIG. 7.
  • the fulfillment list is sorted at block 204 into delivery order according to a delivery routing determined by the institution.
  • the overall order parameters are checked and the list is transmitted at block 206 for fulfillment by the packetizing system. If orders for more institutions need to be processed as detected by block 208, then the institution is incremented 210 and the loop restarts; otherwise the session terminates until a new trigger condition is received.
  • Packaging the individual doses is shown in a simple three block starting at block 214 wherein the individual doses according to the fulfillment list are collected and packaged, followed by shipment at block 216 and notification of shipment at block 218.
  • Prescriptions can be entered by a doctors office, through a secured link (encoded) to a web site interface to the system. It will be appreciated that MS being taken short term (1-2 weeks) may be taken as a separate medication that augments the individualized custom dose packet. However, the system can accommodate even short term changes to a dosing schedule.
  • the medication can be sent out as piggyback doses for the current month of doses, while a permanent or semi- permanent medication becomes part of the patients daily doses, as sent out monthly, for the time period as specified by the doctor. Alternately, if near the end of a month, then the pills can be added to the next months supply which could be sent a little bit early (reduces postage cost & increases convenience). Properly established, the burden of insurance billing can also be ameliorated. Generally the medicine, so prescribed, would be sent out later that same day or overnight. Regional distribution facilities with packetizing order fulfillment provide flexibility with regard to delivery of the dose packets.
  • the entry of personal/medical information at block 340 is confidential but it allows the system to provide enhanced interaction checking. For example an individual may enter their age, weight, sex, specific medical problems, health goals, risk factors (i.e. smoker, drinker) wherein the data base can factor this information in assessing the doses being provided, wherein it may recommend certain supplements that appear proper to the profile given. The individual is still responsible for selecting the doses but the system can provide feedback. When pills are purchased by the bottle, it is not possible to easily assess the combinations of pills being taken.
  • a secure entry point at block 342 provides a hook to allow prescription entry access or access to dose schedules for other authorized health care professionals. Access from the home pages continues via connector "A" at block 344 to FIG.
  • Cramping is an indication which again can be pulled up. While antioxidants are a category which again can be pulled up.
  • the selection list itself comprises item name, description, strength, and cost, while the user can click to get additional information about any of the items and may even open a link to the manufacturer for additional information.
  • the selection list comprises a personal MS list providing rapid access for applying relevant doses to a dose schedule.
  • the selection list at page at block 362 provides a dose selection grid so that the user can apply the dose to the dose schedule which they have established.
  • a selected MS can be configured with a variety of tags, and the user may also add comments to go with the dose item selected.
  • the specific type of medication selected is shown by drop down 418, shown displaying antibiotics.
  • the selection list itself 420 comprises a number of fields.
  • a legend 422 indicates which fields represented, which is exemplifies showing a price per milligram 424, price per thirty tablets 426, and preferably includes miniature photos of the actual MS 428.
  • the selection list 420 contains MS which may be found within the associated MS repository of the system, or operably connected thereto, and it may be scrolled to reach any selection within the repository.
  • the selection list includes names for categories 432 along with specific MS names 434 and basic information about the MS. Additional information may be looked up by clicking one or more of the hyperlinks 436 within the list to retrieve the type of information desired.
  • FIG. 12 represents the population of a dosing schedule 450.
  • the user name "John Q. Doe" 452 is again represented for clarity.
  • the name of the saved personal MS library is daily 454, and ALL weeks have been selected to be identical within the dosing interval which defaulted to one month. Alternatively, single weeks; such as week 1 , week 2, week 3, week 4, and week 5 could be selected such that variations between weeks may be incorporated.
  • the week field 456 may be toggled to allow for adapting an ALL-week schedule with changes to suit the schedule.
  • a template name, "John at Home” was entered for saving the template built with the present page.
  • the category "Antioxidants” is being displayed 460 from the personal MS library and is associated with the list 462, below it comprising a photo of the MS (pill in this case) 464, a description 466 and a scrolling bar 468.
  • Each cell of the dosing schedule represents a single custom individualized dose which comprises a plurality of MS units, whether solid pills or other forms.
  • the system may shrink the image of the MS (pills) 464 when they are inserted within the schedule so that adequate space remains for additional pills.
  • the user selected three dosing intervals for the dosing schedule, and three rows were thus provided 472a, 472b, 472c, corresponding to 8:00 A.M., 2:00 P.M., and 10:00 P.M. as selected by the user within the dosing preferences.
  • a selected MS from the personal library 462 may be dragged and dropped into any slot of the dosing schedule, and multiple clicks will drop multiple MS units.
  • the user wants to place the selected MS unit within each day of the dosing schedule they may drop it into one of the funnels 474a, 474b, 474c on the right side of the dosing schedule, whereupon an MS unit will be placed in each corresponding position of the schedule.
  • MS units may also be removed by dragging them from the schedule into the removal bin 476. This simplifies both correction, and populating a row with but one to three exceptions. It will be appreciated that the system does not allow the patient to select the number of pills or to set an arbitrary scheduling for the taking of medications.
  • the prescription is received in a secure transaction, and the individual is not allowed to change the overall number of pills being dispensed in accord with the prescription and they are not allowed to negatively impact the times at which the pills are to be taken. For example, if the prescription were to indicate taking the pills every 8 hours, then the patient would not be allowed, for instance, to schedule the taking of the medications at four or six hour intervals. This feature provides a large measure of health safety, since the individuals are substantially constrained to taking the correct prescription in order to gain the convenience of the individualized doses. As the MS units are selected, or alternatively entered into the dosing schedule the relationship between the selected MS units is checked to look for interactions, while the MS units are individually checked against the health information provided by the individual to look for contraindications.
  • any information regarding possible problems are displayed within the window of478, which is provided with a scroll bar 480, and a print button 482.
  • the user can elect to have the list verified for content or reimbursement.
  • the user can submit the schedule to, for example their doctor, in this case Dr. Smith, by clicking the button 486.
  • Dr. Smith is then sent an email, or other communication, containing the proposed schedule and information about the selected MS units.
  • the doctor reviews the schedule and either responds back to the user, or depending on preferences, submits the order for processing.
  • the user's insurance company, Health Nut in this case may be queried regarding what they are willing to reimburse by clicking the associated button 490.
  • Additional forms of verification and notification may be provided, and the user may elect to have the order processed without intervention, whereby the order is just submitted by clicking on the submit button 492.
  • the simplicity with which a user may establish individualized custom dosing is readily apparent within the preceding screen shots, and it should be appreciated that a huge amount of functionality is hidden within the upper row of selection mechanisms 494, for example, the Table of the dosing schedule may be manipulated with the conventional row and column selections and manipulations mechanisms.
  • the present system and method for providing individualized temporal dosing has described embodiments for interfacing with a prospective dose consumer, or practitioner, and the establishment of a dosing schedule for which individualized doses are prepared.
  • the present system provides a system and method that provides economical and fault tolerant packetizing of the individualized doses.
  • FIG. 13 shows an embodiment of an individualized custom packetizer 510 according to an aspect of the present invention.
  • the system has advantages over conventional packaging technology which involves the creation of identical product batches at stations arranged over a conveyor.
  • the conveyor/station model requires a fixed periodic product flow while the stations do not lend themselves to a highly customized product.
  • the present invention provides a system in which a fully customized product is assembled within a dedicated factory that is capable of efficient operation over a wide product throughput range.
  • the embodied invention as represented in FIG. 13 contains four pill towers 512, 514, 516, 518 each containing a repository of pills in pill bins arranged as two sets of parallel pill shelves 520, 522. Additional pill towers may be added to the system to increase pill selection.
  • pill shelves contain vertically-stacked rows of horizontal bins which are interconnected by a generally fixed set of traversal paths 524, 526, 528.
  • a set of paths 530, 532a through 532d connect a packetizing station 534 to the pill towers 512, 514, 516, 518.
  • the packetizing station 534 is provided with packaging materials from a receive station 536.
  • Incoming compartmentalized dose assembly vehicles (comdavs) with their individualized custom pill doses are unloaded by inverted rotation and optional vibratory jogging to displace their contents into the packetizing station 534 which seals the individual doses as individual packets of pills.
  • the completed packages are inspected within check station 538 prior to being boxed and shipped out.
  • a primary element of the pill bin 550 is the selector/dispensing mechanism 558 which controls the collection of individual pills from the bin and the ejection of each pill out of the dispensing tube 560. Selecting a pill from the bin requires that an individual pill be oriented and segregated from the bin. It is preferable that the rate of dispensing for the pill bins match the speed of a moving comdav, such requires generally that a pill can be dispensed at intervals of 50 - 100mS. Initially comdavs are set within this embodiment to travel at a single speed which is equal to the maximum allowed loading speed of between one to four feet per second.
  • the pill selector/dispenser is preferably configured for the specific pill type to minimize loading time and minimize jamming.
  • the selector/dispenser should also preferably contain a load counter which verifies that a pill, and only one pill, has been selected.
  • the bin jogger 564 can be activated by the controller 562 to alleviate static friction between the pills and bins to assure proper pill dispensing.
  • the bin jogger 564 vibrates the bin at a variable, preferably sweeping across a range of frequencies to maximize dislodgement.
  • the bin jogger may be implemented from a variety of mechanisms, including: off-center weighted motors, piezoelectric transducers, solenoids, and buzzers.
  • the dispensing tube 560 is oriented to dispense individual pills into compartments of the comdav and contains a set of optical sensors.
  • a first optical sensor is directed toward the passing comdav and detects the bin openings of the comdav as well as bar code information from the moving comdav. In this way the correct comdav is verified prior to dispensement and the dispensement timing is correlated to the bin openings of the comdav.
  • a second optical sensor is directed to verify that a pill, a single pill, has been dispensed into the comdav. Although the selector/dispenser has already checked for a single pill, this detector provides another level of assurance of proper loading.
  • trouble lights/LEDs are located fore and aft on the pill bins so that service personnel can quickly locate the bin experiencing the error.
  • the trouble light is also set up as a watchdog timer and it will turn on automatically if no messages have been received from the shelf controller or the bin controller in the preceding three minutes. This assures that a communication fault or processor breakdown will be detected quickly.
  • the loading of pill bins occurs "off-line", that is the bins are preferably removed from the shelves to be loaded with additional pills.
  • the central controller keeps a constant tally of the number of pills loaded into each bin and each pill dispensed; therefore the central controller tracks the level of pills within every pill bin in the system.
  • Work orders are dispatched for line-workers as the number of pills in a bin gets low, and a backup bin is put into service in one of the pill towers (not necessary the same tower or location as the one that is getting empty).
  • the controller can direct the service person as to the best location for placing any given pill bin to enhance the dose flow.
  • the service person inserts the bin into a rack and tests the bin, then by using a bar code reader, (preferably a belt hung RF transmitting bar code reader) the bar codes on both the shelf and the pill bin are read.
  • a bar code reader preferably a belt hung RF transmitting bar code reader
  • the central controller will have stored the correspondence between pill type and the slot of the rack, and further will know that the pill is now on-line for being dispensed.
  • a bin to be filled may also be filled with a fixed number of dummies (fake pills), wherein the first action of the controller is to dispatch a bin test vehicle, a bindav, to collect the dummies as a check on the functioning of the newly loaded bin.
  • FIG. 16 is an embodiment of computational resources 570 shown in a hierarchical block diagram. Orders for dose packets are received from any number of servers on the network, here represented as a web server 572. The orders are processed within a central order computer 573 which provides shipping, billing, pill requirements, and status information to an ERP (Enterprise Resource Planning) 574 system for the enterprise. The central controller oversees the inventory of the pill bins whose status is maintained in a database 575, and the fulfillment of orders within the system.
  • ERP Enterprise Resource Planning
  • the central computer actually operates a number of program shells with the uppermost application being a device independent database driven application while the lowest level contains the communication protocols and may be configuration for the specific hardware within the packetizing facility.
  • One of the lower level software routines within the central computer contains a representation of the plant layout, procedures, timing, and current status. Schedules are calculated for the orders which are queued up within the database. The schedules are calculated based upon a set of rules which take into account information about the order and the state of the packetizing plant.
  • a track control computer 576 controls the operation of the linear electromagnetics, position sensors, and switches along the fixed path upon which the comdavs operate.
  • the embodiment described contains four pill towers and each is provided with its own controller 578, 580, 582, 584.
  • the pill tower controller is preferably a PC computer such that the monitor provides tower status information.
  • the pill tower controllers also communicate with the track controller 576 as it is the master authority on the position of the comdavs.
  • the pill tower controller communicates with each shelf of pill bins within the tower, in this embodiment the tower has two racks, each containing five shelves.
  • the shelf controller is preferably implemented with an small embedded PC controller.
  • Each pill bin contains a microcontroller to monitor and control the dispensing process.
  • the bin controller is may be a small inexpensive microcontroller such as a PIC16C64.
  • the bin controller is given dispensement directions by the shelf controller based on information received from the tower controller driven by the central controller.
  • the bin controller is very important as it can read bar codes from passing comdavs and will correctly dispense a set of pills into the correct compartments of a particular comdav.
  • the power of the bins for reading passing comdavs is also useful for updating location data on each comdav.
  • the bin controller generates communication in response to communications from the shelf controller (not independently and asynchronously), but can trigger a common fault line, or event line, to asynchronously get the attention of the shelf controller.
  • FIG. 17 depicts the flow of the manufacturing process 600 for creating the individualized custom doses according to the dosing schedule established by the user or practitioner.
  • the process is triggered at block 602 based on time in relation to the desired delivery date and the status of the system.
  • the order of individualized doses is received within the packetizing system at block 604.
  • a vehicle containing a sufficient number of separate collection areas is directed at block 606 to the pill bins.
  • the pill bins are directed to eject pills at block 608 into the separate collection areas within the vehicle.
  • the vehicle traverses the circuitous routing of the pill bins until the desired set of individual doses have been collected in the separate collecting areas within the vehicles, at which time the collecting areas are separately unloaded at block 610 into separate, or segmented packaging wherein each scheduled dose is distinctly retained so that the pills, or other MS, comprising the dose may be separately utilized as a single individualized dose. Markings are preferably applied at block 612 to the individual dose packets to aid identification, and the process is completed at block 614 until another dose order arrives.
  • FIG. 18 is an embodiment of a comdav (compartmentalized dose assembly vehicle) 700, with a view of the top shown.
  • This comdav has a round cross-section and travels in a preferably transparent, tube as it traverses the racks of pill bins.
  • the front of the comdav 702 contains a bar code 704 which can be read by the pill bins that the comdav 700 passes on its traversal of the system.
  • a collection of carriers 706, 708, 710, 712 are attached to one another and the front of the comdav 702.
  • a row of top-side wheels 714, 716 on these comdav carriers lower the friction and stabilize the comdav in the tube.
  • each carrier 706, 708, 710, 712 within each comdav has dividers 718a through 718L such that compartments 719a through 719L are formed within the carrier. Individualized pill doses are loaded into these compartments one by one through a slotted aperture 720, 722, 724, 726.
  • the main front and rear wheels 728, 730 of each carrier can be seen.
  • the magnets within this embodiment of the comdav form one half of a linear electromagnetic drive mechanism, which will be discussed in greater detail later.
  • a cross section view of the comdav is shown in FIG. 20.
  • the slot 720 can be seen as the entrance to a curved path into the pill compartment, having an overlapping cover 721. Use of this curved path provides a cover to prevent pills from being bounced out of the pill compartment 719a through 719L while it smoothly transitions the pill into the compartment.
  • the comdav rides in a tube 750 in FIG. 21 shown with electromagnetic strips 752a, 752b.
  • One strip 752a in FIG. 22 is shown comprising a series of simple coils along its length.
  • This linear electromagnetic drive mechanism for the comdavs is located along the sides of the tubes which contain electromagnetic strips which are composed of a series of inductive windings arranged in a series of phases, and controlled within sections. The alternate activation of the phases of inductive windings creates an electromotive force between the inductive windings and the magnets 725 embedded on the sides of the comdav.
  • the windings operate similar to the windings in a conventional rotating motor, however the windings in this case are spread out linearly to effect a linear translation instead of a rotation.
  • the electromotive forces constitute a driving force which is controlled directly by the track controller.
  • Using this form of linear electromagnetic drive has a number of advantages.
  • the speed of the comdav can be precisely controlled by the track controller.
  • the comdav need not contain its own power source and drive mechanisms, the comdav is therefore a simple mechanical structure requiring no drive electronics and controls. Interaction of the driving wheels on a self-powered comdav with the tube would be expected to create a certain amount of debris which would need to be prevented from contaminating the compartments of the comdav.
  • linear electromagnetic drive allows the comdav to be rotated within the tube for banking at the corners at high speed and for controlled inversion within the packetizer for unloading the pills from the compartments.
  • a further advantage lies in the ability to garner a huge speed advantage. Proper positioning of the magnets and inductive windings can result in reducing the forces on the wheels to near zero. With low friction, banks (non-spill) corners and a powerful drive mechanism the comdavs could be propelled at high speed to more readily assemble the requested doses.
  • the transparent plastic tubes 750 can also be seen in FIG. 13 looping around the pill towers in large ovals and connected with the packetizing station.
  • the tubes are routed helically in an ascent or descent around each pill tower, this is why the towers are paired off, with complementary towers oriented with an up and a down direction tower.
  • a comdav can be routed off the main tube to a pair of pill towers and will pass horizontally among each shelf of the two towers before arriving back again on the main tube.
  • any number can be added to the system.
  • FIG. 23 shows a representative packet-string 760 with a series of separate individual packets 762a through 762f which may be separated from the packet-string.
  • the packets may be made out of an inexpensive material such as cellophane.
  • Each packet 762a through 762f contains a set of pills 763 according to the custom dose selected by the user.
  • a packet, such as 762a, can be separated from the string by the perforations 764.
  • FIG. 24 is a representation of a "piggyback packet-string" 765.
  • the piggyback string 765 is shown with a attachment area 766 that for instance may have an adhesive strip and a set of small pouches containing pills 768a through 768g.
  • Piggyback packet-strings can be used to add pills to an existing set of pill doses.
  • a user receives their monthly shipment of dose packets and then a week later get a new prescription or wants a new supplement. Rather than having to carry a separate bottle, which may be very inconvenient, as well as easy to forget, they can order a piggyback set of doses.
  • the piggyback string in this embodiment is attached "piggyback" to the original string of packets to increase the convenience.
  • FIG. 26 is an elevation view of a pill tower 770.
  • the top of the pill tower 772 is shown built up to a floor 774 on which a service person 776 is standing. This floor provides a deck over which bulk pill storage and bin filling can be accomplished.
  • the floor 774 has openings corresponding with the spaces between the two racks within each pill tower to allow each pill tower to be serviced easily from the upper level.
  • FIG. 25 shows a cross section of the pill tower and the access space from the upper level. On the upper level bins can be filled and carted to the correct pill tower and lowered down into the center of the tower where they can replace depleted pill bins. In FIG.
  • a collection of pill bins 780 are depicted loaded upon pill shelves 782. For simplicity (of drawing) only a small portion of the shelf space is shown populated with pill bins 780.
  • Comdav tubes 784 are shown passing horizontally across the face of each shelf while sloping upwardly 786 on one end of the pill tower 770 to climb up to the next level of the tower. The comdav tube 784 then passes from the highest shelf to a downward spiraling tower by a horizontal curving section 788. A comdav is shown 790 traversing the tower 770.
  • Comdavs are dispatched on an as needed basis and sections of the comdav tubes 784 are only energized as needed to propel a comdav. This "as needed" deployment when coupled with intelligent scheduling by the central controller provides a system which is fully traffic scalable while retaining energy and overhead efficiency.
  • the central computer within this embodiment of the present invention makes the scheduling decisions based on the status of the physical custom packetizing system and the queue of custom dose orders to be fulfilled.
  • the central computer sends an order to the track control system which dispatches a comdav and controls the movement of the comdav amongst the pill towers, routing it as necessary to fulfill the custom dose order.
  • the pill towers are similarly directed so that the pill bins will dispense pills into the comdav according to the customer order.
  • the comdav therefore proceeds around the pill towers, as the bins record the passing of the comdav and even read off its unique bar code; the exact position of the comdav is therefore known at all times.
  • Bins which are to dispense a pill into the comdav are provided with an alert signal when the comdav has almost reached the bin.
  • the pill bin upon reading the correct bar code from the front of the comdav, synchronously dispenses pills as it also senses the openings for each pill compartment along the length of the comdav. Pills are launched via the dispensing tube into each comdav compartment which is to receive a pill to comprise a dose.
  • the shape of the comdav compartment prevents pills from bouncing out of the compartment.
  • the comdav typically is of a length to accommodate the loading of a months supply of doses within the custom order. Each day's supply may consist of a number of doses of different supplements and medications.
  • a person may take four doses of supplements and/or medications with no two of these doses being the same. Dispensement into a comdav therefore is performed with a pill being dispensed into each compartment or each modulo (2,3,4...) of a compartment according to the dose order. If a large number of doses during the day are required, then the months order may be split across multiple comdavs. Pills are added to each dose residing in each compartment of the comdav as the comdav proceeds among the pill bins. When the dose order has been fulfilled, the comdav is routed to the packetizing station where the pills are unloaded from each compartment of the comdav.
  • Pill bins provide a controlled manner of dispensing pills.
  • the shape, method of dispensement, and operation of the pill bins may vary without departing from the teachings herein.
  • a multilevel computer arrangement was described for controlling the assembly of doses within the packetizing system, however, the process control functions involved may be accomplished by any of a wide range of system architectures and individual computers.
  • Bar codes are used for identifying each comdav as well as for locating pill bins and shelves, while alternative locating means can be used.
  • Position detection can be used wherein each comdav is kept track of by the controller, while electronic tags, OCR and numerous other locating/identifying mechanisms exist which may be substituted.
  • the arrangement of the pill bins into towers, as exemplified, is by no means the only manner of arranging the bins of pills. Various shapes and arrangement can be substituted which will similarly allow a vehicle to collect pills from any of a number of pill dispensers.
  • a linear electromagnetic drive is described for moving the comdavs within tubular paths between the various pill bins. It must be understood that vehicles containing conventional motor driven wheels may also traverse these tubes.
  • the tubes may be replaced by other pathways between the pill bins.
  • the comdavs can be configured to determine their own path from one bin to the next. While on a multi-layer arrangement wide paths can be created allowing comdavs to pass one another in transit to a pill bin.
  • Various forms of packaging may be used for holding each set of pills that constitute an individual dose. These forms may comprise sealed cups, envelopes, boxes, trays, and the like.
  • the comdav may likewise be loaded with the unsealed packages into which pills making up a dose are dispensed, whereafter the packetizer need only seal the package to form an individual dose. Additionally the doses being collected may be in the form of liquids.
  • liquids such as lotions, oils, and creams, along with liquid vitamins and minerals. These liquids may be dispensed into small packages for single uses, or a number of liquid supplements can be added to a vessel which is subsequently sealed to create a dose. Unfortunately, as percentage of supplemental and medicinal liquids may chemically interact with one another, the exclusive use of liquid packaging for all dose forms is far less preferable.

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Abstract

Système et procédé pour administrer une séquence de doses individualisées et personnalisées (32) conformes à un horaire de dosage établi dans le temps. Les doses individuelles sont administrées dans un ou plusieurs emballages (34), chaque emballage individualisé et personnalisé comprenant plusieurs médicaments et/ou suppléments et étant séparable individuellement des doses restantes faisant partie de la séquence. Ainsi, l'invention décrit un système dont une interface frontale (16) est basée sur le Web, dans lequel l'utilisateur (12) peut établir un horaire de dosage, sélectionner les suppléments et/ou les médicaments dans une liste de suppléments et médicaments disponibles, choisir lesquels de ces suppléments et médicaments doivent être inclus dans chaque dose et envoyer l'ordre au traitement. L'invention concerne aussi un système de fabrication pour traiter l'ordre; dans ce système, plusieurs véhicules ayant des zones de collecte individuelles passent à côté de plusieurs récipients de collecte et collectent une séquence de cachets dans chaque zone de collecte, lesdits cachets étant chargés dans des emballages séparés ou des parties de ceux-ci. Ces doses individuelles sont étiquetées pour identifier l'individu auquel elles sont destinées ainsi que l'heure à laquelle il faudra prendre chaque dose en fonction de l'horaire sélectionné.
PCT/US2000/035048 1999-12-23 2000-12-22 Systeme et procede de posologie personnalisee WO2001046016A1 (fr)

Priority Applications (3)

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EP00993502A EP1220781A4 (fr) 1999-12-23 2000-12-22 Systeme et procede de posologie personnalisee
AU54411/01A AU5441101A (en) 1999-12-23 2000-12-22 System and method for providing individualized dosing
US10/009,041 US20030200726A1 (en) 1999-12-23 2001-11-08 System and method for providing temporal patient dosing

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US17205799P 1999-12-23 1999-12-23
US60/172,057 1999-12-23
US17696100P 2000-01-18 2000-01-18
US60/176,961 2000-01-18

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AU5441101A (en) 2001-07-03
EP1220781A4 (fr) 2007-04-18
US20030200726A1 (en) 2003-10-30

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