US20100268380A1 - Automated Apparatus for Dispensing Medicaments - Google Patents

Automated Apparatus for Dispensing Medicaments Download PDF

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Publication number
US20100268380A1
US20100268380A1 US12/551,456 US55145609A US2010268380A1 US 20100268380 A1 US20100268380 A1 US 20100268380A1 US 55145609 A US55145609 A US 55145609A US 2010268380 A1 US2010268380 A1 US 2010268380A1
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Prior art keywords
apparatus
medicament
product
bulk
module
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US12/551,456
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Donald Waugh
Peter Suma
Peter Heuss
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MedAvail Inc
PCA Services Inc
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PCA Services Inc
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Priority to US12/551,456 priority patent/US20100268380A1/en
Assigned to PCA Services Inc. reassignment PCA Services Inc. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BESSETTE, DEREK, HEUSS, PETER, OOYEN, WES, PANETTA, RICHARD, WILLICK, TODD
Assigned to PCAS PATIENT CARE AUTOMATION SERVICES INC. reassignment PCAS PATIENT CARE AUTOMATION SERVICES INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: HEUSS, PETER, MR., SUMA, PETER, MR., WAUGH, DONALD, MR.
Publication of US20100268380A1 publication Critical patent/US20100268380A1/en
Assigned to DASHRX, LLC reassignment DASHRX, LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: PCAS PATIENT CARE AUTOMATION SERVICES INC.
Assigned to DASHRX, INC. reassignment DASHRX, INC. CERTIFICATE OF CONVERSION Assignors: DASHRX, LLC
Assigned to MEDAVAIL, INC. reassignment MEDAVAIL, INC. CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). Assignors: DASHRX, INC.
Application status is Abandoned legal-status Critical

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    • GPHYSICS
    • G07CHECKING-DEVICES
    • G07FCOIN-FREED OR LIKE APPARATUS
    • G07F11/00Coin-freed apparatus for dispensing, or the like, discrete articles
    • G07F11/02Coin-freed apparatus for dispensing, or the like, discrete articles from non-movable magazines
    • G07F11/44Coin-freed apparatus for dispensing, or the like, discrete articles from non-movable magazines in which magazines the articles are stored in bulk
    • GPHYSICS
    • G07CHECKING-DEVICES
    • G07FCOIN-FREED OR LIKE APPARATUS
    • G07F17/00Coin-freed apparatus for hiring articles; Coin-freed facilities or services
    • G07F17/0092Coin-freed apparatus for hiring articles; Coin-freed facilities or services for assembling and dispensing of pharmaceutical articles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0076Medicament distribution means
    • A61J7/0084Medicament distribution means for multiple medicaments

Abstract

Apparatus for delivering a medicament to a user has a drug vault including pre-packaged product storage containers holding inventory pre-packaged medicament products, and containers holding inventory bulk medicament. A control system is operable to dispense bulk medicament from the bulk product storage containers, to package the dispensed inventory bulk medicament as dispensed packaged medicament products, and to pick and deliver medicament products to a delivery zone.

Description

    FIELD OF THE INVENTION
  • The present invention relates to apparatus such as a kiosk for dispensing medicaments and, more particularly, to an automated apparatus for delivering a medicament to a patient/user which is adapted to be sited at a location remote from but connected a pharmacy support station.
  • BACKGROUND OF THE INVENTION
  • In this specification, the term “medicament” encompasses drugs and any and all other materials dispensed subject to presentation of a prescription. The traditional means of dispensing prescribed medicaments involves a doctor meeting with a patient and prescribing a medicament based on a particular diagnosis, and then hand writing and signing a prescription for the patient to carry to a pharmacist at a pharmacy location for fulfillment. In recent years, two major advances have occurred in the field of medicament dispensing. The first is electronic prescription capturing methods, systems and apparatus, which improve the overall accuracy and patient record keeping associated with prescribing drugs. The second is the arrival of automated apparatus, typically configured as kiosks, which automatically dispense medication and are located for convenient patient access (for example, in doctors' offices and medical clinics) and are networked into a central computer system for inventory control and management. In this regard, reference may be made to PCT application no. PCT/CA2007/001220 (published on 17 Jan. 2008 under no. WO 2008/006203) for a method, system and apparatus for dispensing drugs, which application is specifically incorporated by reference herein.
  • More specifically, PCT application no. PCT/CA2007/001220 describes a networked system having a server, a database of patient information linked to the server, a first client having input means linked to the server and operable to generate a script for a medicament prescribed to a user, a second client comprising an automated apparatus for dispensing medicaments (referred to in said PCT application as a robotic prescription dispensary) operable to recognize a human and/or machine readable description in the script, and to provide validating cross-referencing between the description and patient information as a prelude to dispensing a medicament to the user on the basis of the input script. A doctor in a clinic can be a third client having input means linked to the server to input the appropriate prescription information, or accept certain prescription information from the database as being applicable in the particular case for a particular patient. Further, the doctor's client device can be operable to display patient information, e.g., drug history, insurance coverage, etc., and a printer module can print the script as a paper print-out.
  • The server and database enable storing, compiling and retrieval of patient data, including name, address, and diagnostic and drug history. Access to the database can be provided to both the doctor and the automated apparatus for dispensing medicaments via the server, via a secure connection, or via a link between the system and a clinic's existing clinic management system or patient database.
  • PCT application no. PCT/CA2007/001220 further describes a user interface, a teleconferencing or video-conferencing means enabling communication between the user and a human validation agent, and a scanning means for capturing an image of the script so that it, if needed, it can be viewed by a human validation agent, such as a licensed pharmacist communicating in the system and with the apparatus from a remote location to the apparatus, to approve a prescription. The user interface of the dispensary apparatus provides detailed and clear instructions to guide the user.
  • An authentication means confirms the identity of the patient, for example, by prompting for a personal identification number or by biometric means or by associating certain questions to answers provided by the patient that identify the patient to the apparatus, and cross-referencing this information with the patient information stored on the networked database. Once the patient is recognized, the dispensary apparatus prompts the user for a script and the apparatus processes the user-input script either by the above-mentioned human validation agent or by processing the machine readable description (which may be a bar code). This information can be verified with the server and the database. The apparatus may also interface with the server to adjudicate an insurance claim and determine the amount payable by the patient. The patient either accepts or rejects the transaction. If the transaction is accepted, the apparatus interfaces with the server to transact a payment, for example, by prompting the patient for credit card information. Prescription labels and receipts are printed. The apparatus confirms that the drug is correct and drops it into a dispensing area for retrieval by the user while retaining the script in a lock box, and verifies that the purchased drug product has been retrieved. Further, the apparatus may also print and/or provide to the user educational materials relevant to the particular prescribed drugs it dispenses to the user.
  • As described in PCT application serial no. PCT/CA2007/001220, the medicament dispensary kiosk may be located in a doctor's office or clinic. The interaction between a patient and the kiosk user interface coupled with access to the various networked functionalities means that a patient can obtain prescribed medicaments without having to attend a pharmacy or drug store.
  • To date, however, the utility of such known medicament dispensary apparatus has been restricted by the limited variety of medications that may be remotely stored or robotically dispensed by them. Therefore, patients, especially those requiring nonstandard dosing, multiple medications, medications requiring special storage or some form of pre-dispense preparation, are often faced with their medication requirements not being able to be fulfilled at such a known apparatus, thereby requiring a trip to a pharmacy for the balance of the prescription and negating the utility of such a dispensary apparatus.
  • In such a medicament dispensary, it is desirable that the first script ratio is high; i.e. that as many users as possible who present prescriptions with a view to obtaining medicaments will be able to fill their prescription at the kiosk without requiring a trip to the pharmacy.
  • The first script coverage ratio really depends on how much variation there is in the population of prescriptions that will be presented at the kiosk and it depends on the range of medicaments available at the kiosk. With regard to range of medicaments, the ratio can be increased by increasing the number of different medicaments that can be dispensed at the kiosk. For example, if there are pills for suppressing headaches and there are pills of a different nature for easing rheumatic pain, then the first script coverage ratio is higher than if there were only either one or the other of the head ache pills and the rheumatic pain pills. Similarly, if there are a variety of medicament delivery mode capabilities such as pill delivery and liquid delivery, then the first script ratio is likely to be higher than if there were just one medicament delivery mode capability. Also if there are a variety of amount dispensing capabilities, such as the capability to dispense any number of pills between 1 and 50, then the first script ratio is likely to be higher than if there were just a single pill dispensing capability fixed at, say, 20 pills.
  • Clearly, if a kiosk is equipped to dispense every conceivable medicament, has every conceivable delivery mode capability and has every conceivable amount dispensing capability, the first script ratio may approach 100%. However, increasing the kiosk capabilities in this way may yield diminishing returns if the expense and complexity of product and operation are also markedly increased. Additionally, adding these capabilities in such a way as to add significantly to the kiosk volume or footprint may present further expense and logistical problems in the sense of readily obtaining convenient and competitively priced sites for such kiosks.
  • In view of these and other user requirements or preferences in the marketplace, an improved automated apparatus for dispensing medicaments is desirable.
  • SUMMARY OF THE INVENTION
  • According to one aspect of the invention, there is provided apparatus for delivering medicaments to users, the apparatus comprising a drug vault having a pre-packaged product storage container for containing pre-packaged medicament product, a bulk product storage container for containing bulk form medicament, and a control system operable to effect at least a part of a process to dispense bulk form medicament from the bulk product storage container, to pack as a dispensed packaged medicament product the dispensed bulk form medicament, and to pick and deliver medicament products to a delivery zone. Preferably, at least a part of the control system is commonly deployed in handling both the pre-packaged medicament products and the dispensed packaged medicament products whereby to limit the volume and footprint of the apparatus.
  • Preferably, the control system includes a medicament packaging module operable to dispense and package the bulk form medicament as a dispensed packaged medicament product that is one of a bottle, a box and a foil package. The apparatus can further comprise a metering module operable to meter a selected amount of the bulk form medicament and to deliver the selected amount from the bulk product storage container.
  • The medicament product can be stored in bulk form as individually dispensable items, with the metering module operable to meter the selected amount of the bulk form medicament as a metered plurality of individually dispensable items. The metering mechanism can further include a singulator successively to take items of the individually dispensable items and to deliver the taken items for packing, and a counter to count the number of items taken from the individually dispensable items and delivered for packing. Typically, the individually dispensable items are one or more of pills, lozenges and capsules.
  • The bulk form medicament may alternatively or additionally be stored in a bulk product storage container as a liquid. With such an arrangement, an alternative or additional metering mechanism is included that is operable to meter the bulk form medicament as a metered volume of the liquid. For certain liquid medicaments, the bulk storage container can be within a refrigerated zone, whereby liquid medicament stored therein is maintained at a lowered temperature to prevent heat-induced deterioration thereof.
  • The apparatus may further including a treatment mechanism operable to alter the bulk form medicament from an inventory state to a dispensing state prior to the bulk form medicament being dispensed and packaged as the dispensed packaged medicament product. For example, the treatment mechanism can be operable to effect at least one of mixing, reconstituting, agitating and diluting of the bulk form medicament.
  • Preferably, the apparatus further comprising a user-interface module configured to receive prescription information input from a user, a control module to interpret the prescription information and to issue commands to the control system on the basis of the received prescription information, thereby to cause the control system to select between picking and delivering the pre-packaged medicament product to a delivery zone, and picking and delivering the dispensed medicament product to the delivery zone. The apparatus may further comprise a network interface for connection of the apparatus into a network, the network interface operable to transmit state of the apparatus information onto the network and operable to receive command information from the network for control of the control system.
  • The drug vault may be configured for secure storage of the medicaments, and be connected to the user-interface module, with the user-interface forming a front end of the apparatus and the drug vault forming a back end of the apparatus.
  • The apparatus may further comprise a product labeling module configured for storing a stock of labels and for labeling a medicament product to be dispensed by the apparatus, the product labeling module operable to suspend a label from the stock of labels, and having an applicator for applying the label to the medicament product, the control system operable to transport the medicament product to the suspended label, and to align a front edge of the label with a pre-determined contact start point on the medicament product.
  • The apparatus may further comprise a validation unit operable within the network to validate the medicament products, the control system configurable to present medicament products to the validation unit for validation of the delivered products. For example, the validation unit may be operable effect one or more of weighing the medicament product presented thereto, monitoring a bar code on the medicament product presented thereto, and recording an image of the medicament product presented thereto.
  • Preferably, the automated apparatus communicates with a remote server linking the apparatus to a computer network, the apparatus having an identification unit to read and recognize a script for a prescribed medicament for a user of the apparatus. The apparatus is preferably configured for receiving through the computer network information regarding the user, the medicament and/or other apparatus of the network.
  • The control system can be configured for communicating in the network and may comprise means for accessing the user-interface module and the drug vault module, the accessing means comprising a plurality of sensors for providing positional feedback information to the control system for controlling the accessing means, picking the medicament from the drug vault module and delivering the medicament to the user-interface module for delivery to the user. The user-interface module and the drug vault module are preferably dimensionally compatible for interconnectability of multiple user-interface modules and drug vault modules in multiple combinations. Preferably, the control system further comprises a state based machine configured to use a state table comprising states for controlling the control system, the states being associated with the positional feedback information provided by the sensors and based on behaviors to be applied by the accessing means to pick the medicament from inventory in the drug vault module. The control system may apply the behaviors according to increasing levels of aggressiveness to achieve success in picking the medicament from inventory, wherein the success is primarily defined to require no jamming of the control system.
  • The network may be a neural network comprising a dynamic knowledgebase of information, including learned information, pertaining to medicaments in inventory in the apparatus and on-going behaviors, and their results, of control systems in the network used for picking medicaments from inventory, and the computer-controlled control system may use the knowledgebase information for controlling the accessing means.
  • The user-interface module is preferably configured for staged security level access by a human operator whereby a first level security access is restricted to access pre-selected components of the front end user-interface module only and a second level security access includes access according to the first level security access and access to the control system and the drug vault module including the inventory thereof.
  • The drug vault may comprise a refrigerated storage module for storing medicaments in inventory in a controlled refrigerated environment, the refrigerated storage module having one or more temperatures sensors for monitoring the refrigerated environment and the apparatus communicates information from the temperature sensor(s) through the network for centralized action.
  • A secure transfer container can be provided for secure transfer of medicament product therein from a medicament distribution center to the automated apparatus. The secure transfer container can be configured for receipt by the control system and self-loading by the control system of the medicament product from the secure transfer container to placement of the medicament product into inventory in the drug vault module. The secure transfer container is configured to restrict access to the medicament product therein to only the distribution center and the control system whereby a common carrier may be used for transporting the secure transfer container. The secure transfer container may be insulated and refrigerated, comprising a solid state cooling device and means for temperature monitoring and configured for powering by means of an external power supply.
  • According to another aspect of the invention, there is provided a method of configuring a medicament dispensing kiosk for a predetermined population of issued prescriptions the method comprising storing at the medicament dispensing kiosk a first plurality of medicaments selected from a first larger set of medicaments, installing at the medicament dispensing kiosk a second plurality of medicament delivery mode capabilities selected from a second larger set of medicament delivery mode capabilities, and selecting a first combination of the first plurality of medicaments and the second plurality of medicament delivery mode capabilities to have at least a first predetermined fraction of the predetermined population of issued prescriptions fillable by said first combination.
  • The method of configuring may further include installing at the medicament dispensing kiosk a third plurality of amount dispensing capabilities selected from a third larger set of amount dispensing capabilities, the method further comprising selecting a second combination of the first plurality of medicaments, the second plurality of medicament delivery mode capabilities, and the third plurality of amount dispensing capabilities to have at least a second predetermined fraction of the predetermined population of issued prescriptions fillable by the second combination of the first plurality of medicaments, the second plurality of medicament delivery mode capabilities and the third plurality of medicament amount dispensing capabilities.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • A description of certain embodiments of the invention are provided herein, by way of example only, with reference to the following drawings, in which like reference numbers refer to like elements throughout the description herein:
  • FIG. 1 illustrates a front view of an embodiment of the automated apparatus for dispensing medicaments in accordance with the invention, wherein two, side-by-side front end user-interface modules are shown;
  • FIG. 2 illustrates an example of a z-axis pick head assembly of the automated apparatus of the invention, with product position and z-axis positional sensors used for determining the machine state of the apparatus;
  • FIGS. 3A-C illustrate an example of a control system of the apparatus of the invention, with robot accessible waste container for placement and storage of suspect or damaged drug product, wherein FIG. 3A is a front view of an example of a back end drug vault module with a control system therein, FIG. 3B detail in perspective and to a larger scale of the control system portion of FIG. 3A, and FIG. 3C is a sectional view from above of the control system of FIG. 3A taken at section B-B;
  • FIG. 4 illustrates a front view of an example of an internal configuration of a back end drug vault module of the automated apparatus of the invention, showing multiple, networked cameras at locations within the apparatus;
  • FIGS. 5A through 5B are perspective views of front end user-interface modules of an embodiment of the automated apparatus of the invention, as per FIG. 1, and FIG. 5C shows an opened apparatus, together illustrating increasing levels of security for access to the apparatus: FIG. 5A shows a first level of access security for which the front of the apparatus remains closed so as to require software controlled function access in order to load inventory, with no physical access into the apparatus being provided; FIGS. 5B1 through 5B3 show a second level of access security for which the front of the apparatus can be opened via controlled access to gain access to user interface components of the apparatus and to service the apparatus components accessible at this security level; and, FIG. 5C shows a third level of access security for which the back end drug vault module of the apparatus, containing medicaments, is opened;
  • FIG. 6 illustrates a front view of an example of a back end drug vault module of the automated apparatus of the invention, with a controlled room temperature top section and a controlled refrigerated bottom section;
  • FIG. 7 illustrates an example of a pill counter module integrated into a bulk storage container for pill/capsule product, for counting pills to be dispensed by the apparatus of the invention;
  • FIGS. 8A-B illustrate an example of a packaging module of the automated apparatus of the invention, for packaging drugs to be dispensed to a user in bottles or foil packs, wherein FIG. 8A is a perspective view and FIG. 8B is a front view thereof;
  • FIGS. 9A-9B illustrate an example of a drug storage module of the automated apparatus of the invention, showing multiple, standard slots for housing bulk storage cassettes therein, and an exemplary bulk storage cassette in one such slot, for retrieval by a robot of the apparatus and transfer to a packaging module, wherein FIG. 9A is a perspective view thereof and FIG. 9B is a detail view to a larger scale of portion A of FIG. 9A;
  • FIGS. 10A-F illustrate a package labelling module of the automated apparatus of the invention, wherein FIG. 10A illustrates a top view of a labelling assembly thereof, FIG. 10B illustrates a perspective view of the labelling assembly of FIG. 10A, FIG. 10C is a is a detail view to a larger scale of n exploded view of area C of FIG. 10A, FIG. 10D is a sectional view taken at line D-D of FIG. 10C, FIG. 10E is a sectional view taken at line A-A of FIG. 10A and FIG. 10F is a sectional view taken at line B-B of FIG. 10A;
  • FIG. 11 illustrates a laser marking module of the automated apparatus of the invention, configured for direct marking of label information onto a package to be dispensed by the apparatus to a user;
  • FIG. 12 illustrates a front end user-interface module according to one embodiment of the invention. The module having a manual product load slot for manually loading product, whereby the product passes to the control system for automatic self-loading of the product into the drug vault by the control system of the apparatus;
  • FIG. 13A is a perspective view of automated apparatus according to one embodiment of the invention showing automatic self-loading of a delivered secure transfer container to and FIG. 13B is a detail view to a larger scale of region A FIG. 13A;
  • FIGS. 14A-D illustrate one example of a secure transfer container for use with the automated apparatus of FIG. 13A, wherein FIG. 14A is a perspective view, FIG. 14B is a right side view, FIG. 14C is left side view and FIG. 14D is a top view thereof;
  • FIGS. 15A-D illustrate a multiple slot, storage container rack for one embodiment of automated apparatus, the rack having multiple, standard slots for housing bulk storage containers therein, showing one slot thereof containing five bulk storage containers with each container storing a different drug product, wherein FIG. 15A is perspective view, FIG. 15B is a top view, FIG. 15C is a front view and FIG. 15D is a side view;
  • FIG. 16 illustrates a perspective view of an embodiment of the automated apparatus for dispensing medicaments in accordance with the invention, wherein two, side-by-side front end user-interface modules share one back end drug vault module;
  • FIG. 17 illustrates a perspective view of another embodiment of the automated apparatus for dispensing medicaments in accordance with the invention, comprising four, side-by-side front end user-interface modules and two back end drug vault modules, whereby each of two side-by-side front end modules share one back end drug vault module;
  • FIG. 18 illustrates an exemplary sub-assembly of two inter-connected back end drug vault modules of the automated apparatus of the invention, each module configured for modular construction of the apparatus;
  • FIG. 19A illustrates a front view of an example of a refrigerated storage module of the automated apparatus of the invention with cooling device, insulated sliding door, locking unit and air purge means provided by a dehumidifier and pressure control unit, and FIG. 19B illustrates a perspective view of this exemplary module;
  • FIG. 20 illustrates a side view of the module of FIG. 19A;
  • FIG. 21 illustrates a top view of the module of FIG. 19A;
  • FIGS. 22A-B illustrate an example of a refrigerated secure transfer container for use with the automated apparatus of the invention, wherein FIG. 22A shows a front view and FIG. 22B shows a side view thereof;
  • FIGS. 23A-C illustrate an example of a bulk storage container for prepackaged product of the automated apparatus of the invention (one such container shown installed in the apparatus in FIG. 9), wherein FIG. 23A shows a perspective view, FIG. 23B shows a side view and 23C shows a front view thereof;
  • FIGS. 24A-B illustrate one example of a bulk storage container for storing pills and/or capsules therein, and having a pill/capsule counter integrated into the bulk storage container, wherein FIG. 24A is a front view and FIG. 24B is a side view thereof;
  • FIGS. 24C-H illustrate another example of a bulk storage container for storing pills and/or capsules therein, and having a pill/capsule dispenser and counter associated with the bulk storage container, wherein FIG. 24C is a view from above, FIG. 24D is a perspective view from above and one side, FIG. 24E is a view taken on the line B-B of FIG. 24H, FIG. 24F is a front view, FIG. 24G is a side view and FIG. 24H is a vertical sectional view on the line A-A of FIG. 24F.
  • FIGS. 25A-B illustrate an example of a bulk storage container for storing liquid medication, and having an integrated liquid pouring unit, wherein FIG. 25A is a front view and FIG. 25B is a side view thereof;
  • FIGS. 26A-C illustrate an example of a reconstitution bulk storage container for both storing a liquid medication and reconstituting that medication with another liquid prior to dispensing, wherein FIG. 26A is a front view, FIG. 26B is a side view and FIG. 26C is a perspective view thereof;
  • FIGS. 27A-B illustrate an example of a mixing bulk storage container for storing multiple different liquids and mixing them together prior to dispensing, wherein FIG. 27A is a front view and FIG. 27B is a side view thereof; and,
  • FIGS. 28A-B illustrate an example of a compounding bulk storage container for storing multiple different liquids and compounding and mixing them, for geometric reduction with a carrier, prior to dispensing, wherein FIG. 28A is a front view and FIG. 28B is a side view thereof.
  • DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
  • The invention provides an automated apparatus for dispensing medicaments which advantageously provides improved utility to expand the variety of medicaments that can be stored, prepared and dispensed. Its utility is enhanced by increasing the prescription coverage ratio offered a patient at an autonomous network device or drug dispensary apparatus. This utility of service provided by the apparatus may be viewed from the perspective of a patient (i.e. user) standing at the doctor's office with a prescription in hand and needing immediate medication. The distance the patient must travel and the frictions the patient must overcome to get the medication is the patient's utility function. Utility from the perspective of the drug dispensary, be it a pharmacy or a remote dispensary apparatus as provided by the present invention, means how many items on the patient's prescription could be filled, not requiring secondary actions, such as ordering the medication requiring the patient to return for pick up, or delivering the medication to the patient at a later time. Thus, for both the drug dispensary and the patient, maximum utility is determined by the ability to dispense all medications required, on the spot, at the time of the initial interaction.
  • Advantageously, the dispensary apparatus 10 of the invention is constructed from a pre-selected number and functional type of modular components, hereinafter referred to generally as modules. These modules include a front end user-interface module 20 (see FIG. 1 which illustrates two such modules located side-by-side), a back end drug vault module 200 in which drug product for dispensing is stored and a control system 100 (see FIGS. 3A-C) which is located for operation with both the front end and back end modules. These modules are dimensionally compatible for assembly in numerous combinations, as desired for a particular application, and their internal components are sized and shaped to conform to a grid configuration to enable such compatibility and interconnectability, such that numerous combinations of modules can be assembled and interchanged as desired. This allows an unlimited number of combinations to be configured from an inventory of interchangeable, compatible modules and allows the apparatus to accommodate a wide variety of requirements for a given application.
  • The front end user-interface module 20 is provided both as a half size and full size module allowing, for example, one large and two small user front ends to be attached to a back end module 200, or two, three or four front end modules to be attached to two back end modules. Within the back end module 200, several optional configurations may be assembled to accommodate product inventory as desired. For example, within a back end module 200 any combination of product storage modules may be selected. A controlled room temperature section 240 may be included together with a refrigerated temperature storage section 250, as shown in FIG. 6. Multiple storage container racks 205 may hold any combination of product storage modules, as shown by FIG. 6, including product storage containers 210 for pre-packaged product, bulk medication storage containers 220 for liquid product and bulk medication storage containers 230 for pill/capsule product. If desired, a reconstitution, mixing and/or compounding bulk medication storage container 370, 380, 390 can be added in place of a refrigerated storage module 250 or assembled into a second back end module 200.
  • The modularity of the components of the apparatus is defined in standardized manner to dictate dimensions, key contact points, power, network configuration points and mechanical features, to ensure interoperability for all components and their associated software, hardware and operational parameters.
  • The front end user-interface module 20 is independent from the back end drug vault module 200, whereby they may be co-located in a single chassis as a unified apparatus, or located in appropriate multiples to meet a particular service location requirement. Most commonly, multiple front end modules 20 are co-located with a single back end module 200 and both front ends (or multiple front ends) are serviced by a single control system 100 and back end drug vault 200. This is shown by FIGS. 16 and 17, in which FIG. 16 shows two, side-by-side front end user-interface modules share one back end drug vault module and FIG. 17 shows four, side-by-side front end user-interface modules and two back end drug vault modules, whereby each of two side-by-side front end modules share one back end drug vault module. Multiple back ends can also be linked to extend storage capacity to serve a front end user-interface cluster. FIG. 18 illustrates a sub-assembly of two inter-connected back end drug vault modules. A further configuration, which may be desirable to service remote communities with low transactional volumes and long times between inventory replenishment, is multiple back end modules 200 serving a single front end module 20.
  • The control system 100 is improved to, inter alia, provide dispensing reliability of pre-packaged drugs which have a range of sizes, shapes, weight and weight distribution (e.g. a heavy dense glass vial on one side and light weight dropper on the other side of a package renders an uneven weight distribution for the package), slipperiness of packaging, tabs, stickiness, moisture (e.g. from absorption by cardboard), all of which create a plurality of handling problems for robotic systems. Also, drug companies frequently change packaging, so control algorithms may become ineffective when a package change alters an SKU (Stock Keeping Unit) which may be used by the robot to identify the package. Therefore, a robotic control algorithm that prescribes a handling method based on pre-recorded product package information (weight, size, etc) is subject to errors, simply because the packaging was not intended for automated dispensary, and there are currently more than four thousand package variants for common medications, that vary by region, manufacturer, re-packager, or distributor. To try to deal with this problem, some known systems create uniform over-packaging to assist in robotic dispensary reliability, but this adds additional handling and expense to the dispensary process, a significant increase in the opportunity for error, and additional waste stream burden to products already notorious for over packaging.
  • The control system 100 overcomes the foregoing problems of the prior art by using a “state based machine” based on controls, behaviours and sensors on the robotic pick head 50 (see FIG. 2). Current medicament packaging is generally designed for handling by personnel, not automated machines or robotic machines.
  • Humans can compensate instantly and intuitively to variations, changes and anomalies. Machines such as robotic dispensaries are not smart, and require a refined set of behaviors to compensate for common anomalies. As shown in FIG. 4, several networked video cameras 150 are installed inside the apparatus 10 to view what is taking place in the apparatus, and this visual information is used by the control system 100 as well as remotely, if needed, by a human agent. To compensate for the fact that machines, unlike humans, do not intuitively compensate for gripping items, the control system 100 is computer-controlled by a state machine (being firmware), associated software and a z-axis encoder 80 (for positional feedback control) to react to what happens and read the values of the various sensors, which include product position sensors 60 and z-axis positional sensors 70. For example, if a drug product being picked from inventory by the control system 100 is fully registered to be positioned at the back of a platen of the pick head assembly 50, then the control system 100 knows that was a successful pick and a tractor of the assembly can then feed it off correctly. A computer of the control system 100 knows the length of products so the module determines from the sensors 60, 70, being simple light beam sensors, where a product should be located. The array of sensors 60, 70 enables the control system 100 to determine what state it is in at any given moment. The control system 100 operates, for example to pick a product out of the back end drug vault module 200, by using “state tables” of approximately 385 states, each state functioning as a rule.
  • Intelligence is provided to the dispensary apparatus 10 to solve problems, this being achieved by pick head sensors 60, 70, product information, machine states, behaviors and behavior results. A state determination is made from sensors and product knowledge, determination of a state leads to a selection of behaviors, behaviors are executed in order of success and success of behaviors for particular states increases the intelligence (knowledge learned) of the apparatus and system.
  • The hardware of the control system 100 operates at a first layer of control, while the state machine operates at second layer. The hardware includes a set of behaviors, including jiggle pick, shelf recovery, and others. The state machine drives which of the behaviors the robot is to apply and a series of states are provided with a score. The states know whether one state is better than another. For example, an optimal state would be registered where a product is located at the correct identifier number with the sensors identifying it to be fully registered at the back of pick head measured against product specific information out of the system's database. At the time of a product pick by the control system 100, the product is known because it was measured and its length was recorded when the product was serialized and put into inventory in the apparatus. Also known by the control system 100 is the size, the weight, the shape, the moment arm, and other particulars pertaining to the location of the product to be picked.
  • The software driving robot knows what it is supposed to expect and the robot deduces what states should occur in order to be successful. It also deduces when it gets into a state relative to what the product is and by combining the product information and sensor information it deduces what to do next be successful. The control system 100 is controlled to do anything it can deduce to be successful.
  • A neural network is used by the system and each networked control system 100 to allow it to learn from previous actions and results. State transitions may provide learning knowledge to the control system 100. For example, if the robot achieved a particular state and used a particular behavior to get to that state, this is learned knowledge which is maintained by the control system 100 for future use. A collection of 25 different behaviors is applied by the robotic. If the robot is in a similar state as it was previously, and it previously tried a behavior which did not succeed, then it will not try the same behavior and, instead, will try another behavior. The control system is controlled to apply behaviors on the basis of risk levels, to become progressively more aggressive to achieve success. In a state table the states reflect this progression for control of the robot so that, for example, it will attempt 1 for, say, shift recovery, then attempt 2 for aggressive shift recovery, and then attempt 3 for maximum shift recovery.
  • The control system 100 is also controlled to do anything in its power to get unstuck, so it doesn't jam (since the apparatus is unattended). The primary rule applied by the robot is that it must not jam. For the robot, to not a make an error is a lesser rule (having lower priority) because the robot has access to a waste container 115 and a waste arm 110 which it uses to direct damaged product. If the control system 100 detects an error it transfers the product to the waste container. The robot applies it hardware, then state machine behaviors to achieve its primary directive of no jamming.
  • If after three attempts to pick a product it is not successful, it reverts to remote control mode by invoking a call center screen for a human agent who is alerted that an error occurred and manual recovery is required. The human agent can look at the screen through the network and can summon a technical person to commence a remote control application over the network which pilots the robot in real time, enabling the robot to service a user who is standing at the apparatus 10.
  • The control software of the control system 100 acts to try to correct errors when they occur. The robot picks a product from its storage location by bringing the pick head 50 to the storage location slot 207. The slot 207 has a gap in front to allow the pick head 50 to insert a tongue into the slot under the product. The pick head 50 has multiple belts (or wheels or fingers) to pull the product forward as the pick head moves up and onto a shelf of a storage container rack 205 while lifting the product up. This action picks up the first product on the storage shelf location, separating it from the remaining inventory, which is to (ideally) remain on the shelf. The pick head 50 then senses the size, shape, weight of the product it has picked to determine that it has picked a single product unit and determine that it has overcome three common errors, namely, a stuck pick (where the product sits in place due to slipperiness), double pick (where two products are either in close proximity, tangled together or stuck together) and multi pick (usually due to labels sticking together). The state machine, using sensors and a tables of information about the inventory product being dispensed, determines the error based on the physical parameters of dimension and weight and, for product containing RFID (Radio Frequency Identification) tags, by scanning and detecting the presence of more than one RFID tag, or more that one bar code if bar codes are presented in such a configuration as to make them visible.
  • Based on the foregoing information, the control system 100 determines with a high degree of accuracy whether the product is present, whether an error exists and, if so, the state of the error. Upon occurrence of an error, using the error state information the robot implements an escalating series of interventions in an attempt to resolve the error. If no product is present in the pick head 50 and the robot knows there is product in the slot 20, then machine state is a stuck pick. In this state, the robot implements a first level stuck pick resolution action called “Jiggle Pick”, for which a software control loop causes the robot to oscillate up and down within a range of motion and velocity determined to be appropriate for level one resolution range. With “Jiggle Pick”, distance is important for effectiveness and to minimize damage to the robot, storage shelf and product. Sensors on the pick head determine penetration into the shelf and maintain a safe distance from the surfaces to minimize the possibility of contact damage. “Jiggle Pick” causes the stuck product to unstick from the shelf, in much the same way that a vibratory conveyer overcomes friction to move goods.
  • Two products may stick together causing two products to be loaded into the pick head rather than one product. In the storage bin, the mean angle between the panels of each product box is shallow and this may cause two package boxes to mate when sitting next to each other with pressure or if cardboard and subject to humid conditions.
  • This increases the chance that when the pick head lifts one box, it may actually lift both, creating a double pick error. To resolve this, an escalation to a level two remedial action is implemented by the local control software creating a shift higher on the control head, to alter the angle the product is held at, thereby reducing the contact area between the first and second product, to create a separation angle, and create the contact point that disallows mating, therefore only pick one box.
  • A third common pick problem is multi pick, where several products are stuck together, typically due to the label or label glue affixing several packages together. The sensors and machine operating software are able to determine a multi pick error based on weight, moment arm of the load, dimensions of the load and load behaviour measured by parameters of acceleration and deceleration lag. If the multi pick error cannot be resolved by the foregoing resolution one or two, the local operating software escalates to resolution three, whereby an edge of a pick bin is used as a guillotine to wipe the redundant products from the picked product. As the wiped product may have been damaged or compromised by a level three intervention wiping action, any wiped product is placed in the waste container 115 and is not dispensed without prior confirmation of integrity.
  • A drug dispensary apparatus must be reliable, measured primarily in terms of availability for service. The ideal machine would be one that never fails, but the very nature of integrated communications, software and hardware, and variety of products and packaging that must be handled, invariably lead to an error rate greater than zero.
  • However, errors are probable and, therefore, error management, isolation and recovery are paramount to prevent failure. A core reliability algorithm used by the apparatus 10 of the invention is defined in terms of absolute parameters or edicts. Each edict overrides subordinate edicts, with edict one overriding all others. The edicts are the following:
      • Edict One: Patient Safety—No activity can compromise patient safety.
      • Edict Two: Protection of Assets—No activity can compromise in order, the security of the drug inventory or the security of the machine.
      • Edict Three: Maintain Operability.
  • Edict One is described in detail in the above-identified published PCT application (WO 2008/006203). Edict Two requires escalating procedures that do not require the machine or the drug vault to be opened. Edict Three requires that the escalating procedures be as succinct as possible to maintain an in service status and core utility of the apparatus.
  • The dispensary apparatus 10 is networked to a computer system so that any error occurring at the apparatus with respect to product (SKU) becomes a shared network experience and part of a common error record contributing to the accumulated knowledgebase of the system. Error parameters forming trends can be analyzed, such as, errors common to a specific machine, or specific machine configurations, or specific conditions, or specific packaging or product variants. As components of a neural network, each software controlled robot has pre-programmed autonomous actions, and being a state machine is able to adapt to changes to deliver the desired result under the control of a strictly applied rule set.
  • As stated, the robot's state machine in effect learns to recognize conditions and acquires knowledge in the form of a recorded history of the result of various solutions, thereby adding to the collective operation knowledgebase, to allow the robots of each of the networked dispensary apparatus 10 to learn from a successful outcome. For example, a product jam that entraps the pick head is a common reason for a dispensary apparatus to be out of service. The robot has a set of procedures to unstick itself. It knows its slot location and it knows the product SKU on the platen, but it may find that its X and Y axis movements are arrested.
  • If the database has no prior occurrence of this specific problem, the software begins the following resolution sequence, starting with the least destructive behavior: jiggle gently, yes/no resolution; escalate to jiggle intensely, yes/ no resolution; escalate to jiggle intensely while puffing back the platen, reversing the pickup belts and while applying X axis up, to force the product free, sacrificing the product to the discard bid (this action will discard one product SKU), yes/no resolution; escalate to ramming the platen forward into the slot and elevating the contents of the slot, then dropping them into the waste container (this action will discard all remaining product SKU's in the slot, but if successful, frees the robot to pick and dispense from the remaining slots), yes/no resolution; revert to shut down, call for help center technical intervention, open a remote pilot session, whereby the multiple cameras within the apparatus allow a technician at a remote repair center location to see inside the apparatus and to take over remote piloting of the robot to resolve the issue (this action avoids on site intervention and the apparatus is not opened so no security issues arise with this intervention), yes/no resolution; escalate to local call out whereby a qualified local technician who is certified to enter security level one (front of machine) is dispatched to the site, opens the front of the machine and can repair the problem if it is external to the drug vault, yes/no resolution; lastly, escalate to truck roll whereby a senior technician is called out, and the senior technician is authorised to security level two (drug vault access) and can resolve the issue by opening the back end drug vault module(s).
  • The foregoing staged error resolution process, by which the dispensary apparatus 30 determines when an error state occurs and is able to resolve the error which has been detected, serves to maximize the in-service time of the apparatus, maximize patient utility, provide a rapid response to an error, provide a low service cost structure and optimize security for the machine and the drug inventory.
  • The physical security of the dispensary apparatus 10 is enhanced by a staged access configuration of the apparatus as illustrated by FIGS. 5A through 5C. Access level one is illustrated by FIG. 5A and FIGS. 5B1 through 5B3 and provides access at locations 160, 170 to the front part of the apparatus which houses the user interface components, waste section, pick head garage and regular dispensary service items.
  • Access level two is illustrated by FIG. 5C and provides access to the drug vault module including its refrigerated section (if any) and its bulk storage containers which controlled and isolated. Two types of security are applied to these access levels. The technician must have a valid ID badge to allow entry to the front end of the apparatus.
  • A network video camera confirms the identity of the technician, that the technician's credentials are current and authorize the technician to access the machine at that time and that there is a work order created to track time and activity at the dispensary apparatus. In the event that a network connection cannot be established by the apparatus due to network interruption or prolonged power failure beyond the hold up time of an internal UPS, a controlled access key can be used for access to the level one interior space to restore power or network connectivity. Access to the level two controlled regions of the apparatus, such as the drug vault module, can only be achieved with network confirmation.
  • To optimize the user's utility in relation to the dispensary apparatus and serve a high traffic level, the apparatus must provide a high level of prescription coverage. An obstacle to doing so is that some medications, like insulin for diabetics, eye drops for glaucoma and several pediatric medications, require refrigeration for storage and such medications can be rendered ineffective if stored outside of their temperature range (e.g. if outside such range by two to eight degrees Celsius). On the other hand, some medications such as syrups require room temperature storage which is defined as fifteen to twenty-nine degrees Celsius.
  • Advantageously, the dispensary apparatus 10 of the invention overcomes this obstacle by providing an isolated refrigerated section 250 in the drug vault module 200 that can store medications at controlled refrigerated temperatures in combination with a controlled room temperature section 240 in the drug vault module 200 to store medications at room temperature, as shown by FIG. 6. The apparatus also contains monitoring sensors (not shown) within the storage areas to sense internal temperature for the purposes of control of temperature, as well as to monitor temperature to report to a log file for correct temperature storage verification for a drug pedigree file and to report any temperature fluctuations in the form of high or low temperature alarms to the network for remedial action. Any drug that has been exposed to a temperature, or time and temperature beyond its allowable range is tagged to identify this via a drug pedigree established by the system and is removed from accessible inventory for disposal.
  • As in the known medication dispensary apparatus, the apparatus 10 of the invention is able to dispense only pre-packaged product, being single unit items referred to as “standard dosage” items or packages. Pre-package products indicate that the items are appropriate for use in the dispensary and for dispensing to users but the actual number of pills, capsules, etc., contained in a given standard dosage package will vary based on the drug and dosing regimen. This regimen is derived from information provided by the drug manufacturer and the common dosing practices for the drug in question. However, from the perspective of utility function for the user, the dispensary apparatus is non-functional if the prescription requires 10 pills and the apparatus only stocks 8 pills standard dosage packages. The apparatus 10 solves this common problem by providing in its back end drug vault module 200 a bulk medication storage area 215 and pill counters 270 integrated into bulk storage containers for pill/capsule products 230.
  • A common problem encountered in autonomous pill counting is reliable, secure and clean handling of medication without cross contamination. The apparatus 10 includes a larger bulk pill/capsule storage container 230 that allows medication to be securely stored in bulk and sealed, and only touched by dedicated handling equipment until dropped into a dispensary package and dispensed to the user. This conforms to a no touch technique SOP to eliminate the possibility of cross contamination. The storage container 230 has specific dimensions to allow it to be stored in a standard storage slot, and specific features to enable reliable handling by robot. It also has specific security features to make it tamper resistant in transit.
  • The bulk pill/capsule storage container 230 is shown in FIGS. 24A-B and allows the robot to select and cause pill/capsule medication to be delivered to a counting unit comprising a pill singulator 260 and counter 270 which are integrated into the container 230 as shown by FIG. 7. Tablets or capsules are stored in hopper of the container 230.
  • In one embodiment of pill dispenser, a vibratory scroll feeder (not shown) aligns the medication from the hopper, before it passes to the counting unit which counts the number of pills or capsules directed by the robot. When the product count is reached, a flap mechanism (not shown) diverts the pill flow back to the bulk storage container 230.
  • Another embodiment of pill dispenser is shown in FIGS. 24C-H. Each of an array of bulk storage containers, of which one 402 is shown in these figures, contains pills 404 of a certain type. The container 402 has a pill guiding exit chute 404 and a vertically disposed, integrally formed cylindrical exit nozzle 406. Mounted within the exit nozzle is an annular cylindrical limiter 408. The limiter 408 can be moved up and down within the nozzle 406 by a drive mechanism (not shown) to alter the width of an annular exit region 410 extending between the limiter 408 and a conical hub part 412 of a disc 414. A ring gear 416 on a lower surface of the disc 414 has teeth that mesh with a pinion gear (not shown) from which a drive is taken to drive the ring gear to rotate the disc 414. The disc is mounted so that its upper surface slopes downwardly towards the hub part 412 to define a dish form. The disc 414 is formed, at least at its upper surface, of a material having a high friction coefficient and also has an integrally formed series of low profile curved fins 418.
  • As shown in FIG. 24C, mounted above and with its lower edge closely adjacent the disc upper surface is a wiper guide 420, the guide having an inner end close to the hub part 412 and a generally spiral form extending almost to an outer edge of the disc. Mounted close to the disc upper surface and immediately adjacent a barrier wall 422 within which the disc spins is a separator 424. The separator is a generally radially extending plate which, with the barrier wall 422 and the disc upper surface, defines a triangular shaped opening. The separator 424 is downstream of the end of the spiral wiper guide 420 in the disc spin direction and a radially reciprocal gate 426 is downstream of the separator. The wiper guide, separator and gate are shown only in FIG. 24C.
  • In operation, a prescription is read and interpreted as previously described and instructions are sent to a pill dispenser control module indicating that a prescribed number of pills of a certain type are to be dispensed from an inventory store of such pills contained in a selected one of the bulk storage containers 402. As a result of the instruction, drive is provided to the selected pill dispenser to cause its drive gear to start the disc 414 spinning. A further drive is applied to move the limiter 408 to a predetermined position at which the size of the annular exit region 410 is appropriate to allow successive pills 404 to fall under gravity at a metered rate through the exit region 410 and onto the disc upper surface. The limiter position is set so that the rate at which pills pass through the exit region is not so large as to overload subsequent pill counting and pill packaging stages of the apparatus, but is also not so small small as to result in jamming of the pills in the exit region 410. Once the pills fall onto the disc upper surface, the disc surface, the fins 418 and the wiper guide 420 interact to drive the pills in a spiral path towards the barrier wall. Pills driven towards the outer edge of the disc tend to become distributed and to be driven in arcuate paths next to the wall barrier 422. Ideally, the pills are strung out and pass successively through the opening in the separator 424. If however multiple pills adhere together owing to static friction or other surface condition, the separator 424 allows passage of only one of the adhering pills at time with any adhering pill being stripped away and subsequently presented to the separator by the spinning disc.
  • Under a solenoid drive (not shown) from the control module, the gate 426 is held in an open, pill passing position as long as a full count of the pills to be dispensed has not been reached. After the pills are discharged through the gate by the disc drive, they fall through a count zone 428 into a previously positioned empty pill bottle. In the count zone, the pills drop past an array of photodiodes and associated photodetectors (not shown). The photodetectors are set to record a pill count as each pill drops into the pill bottle. Software control is applied to close the gate when the number of pills counted matches the number of pills prescribed on the prescription.
  • Prior to the pills being dispensed through the count zone, an empty pill bottle is brought to the selected pill dispenser and lodged in a position where the pills dispensed from the bulk storage container drop into the bottle. The pill bottles are retrieved and moved by the control system which, as previously described with respect to the picking and delivery of pre-packaged medicament products, can be driven on X and Y axes to range over the full vertical area of the medicament vault. The control system can also be moved to a bottle zone where an array of empty bottles of various shapes and size, together with an array of matching caps, are stored. The control system incorporates a pick head described previously with respect to picking the prepackaged medicament products, the pick head having a finger and hook with the finger being reciprocable along the Z-axis. In operation, at the bottle zone, the finger is driven in the Z-axis direction to a position under a slot in the base of a container into which the bottle is dropped following previous software controlled selection and release from a bottle storage bandolier. As in the case of the prepackaged medicament product manipulation, the finger is moved upwardly in the slot to support the empty bottle. As the finger is withdrawn along the Z-axis, the hook engages the bottle to withdraw it from the container.
  • Also mounted on the control system is a platen. An articulator mechanism forming part of the control system grips the empty bottle and moves it onto the platen and into an upright position where it is locked relative to the platen. The control system is then operated to deliver the platen to a position where the standing bottle is positioned to receive pills that drop from the selected pill dispenser.
  • The control system also includes a cap pick and placement module. Following the dispensing of the desired number of pills into the bottle as previously described, the cap pick and placement module places a selected cap on the on the open neck of the bottle and a levering mechanism applies downward pressure on the cap to snap it over the neck. The control system is then driven to deliver the bottle containing the dispensed pills to a delivery zone accessible by the kiosk user.
  • It will be understood that FIGS. 24A-H describe just two forms of pill separator and counter for use in a networked arrangement to dispense both pre-packaged and bulk medicaments. The invention envisages other forms of dispenser for pills, lozenges and capsules and also envisages the dispensing and packaging of bulk liquid medicament in an arrangement that is similar to the pill dispensing arrangement other than design changes to accommodate the handling of a liquid.
  • Both in the pill dispensing and the liquid dispensing arrangements, care is taken to avoid contamination of the medicament being dispensed. Thus, where possible mechanical control elements are encapsulated and contained to avoid the escape of dust and vapours. In addition, where possible, dust, liquid and vapur seals and barriers are installed at locations where elements of the dispensing mechanism move relative to one another.
  • The prescribed medication is then transferred to a medication packaging module 280 (see FIGS. 8A-B) via a vibratory scroll feed conveyer mechanism (not shown). Alternatively, the apparatus could be configured for placement of the medication packaging module at the counting unit's discharge port. The bulk pill/capsule storage container 230 is sealed and secured.
  • Optionally, the apparatus 10 may be configured so that the bulk pill/capsule storage container 230 can only dispense medication when inserted into a dispensary module under control of the robot. Such a configuration allows for tight batch and inventory control and maintenance of the drug pedigree. The prescribed counted medication is loaded into a hopper 290 of the packaging module 280 and is packaged by a bottle or foil packager 300, 310 of the packaging module 280. Optionally, the medication count may be verified optically during the transfer between the counter unit and the packaging module. The hopper 290, vibratory conveyer and counting unit (and optionally the transfer port) are optically inspected to confirm that no medication remains at those locations (i.e. no medication was left behind), before the bulk medication container 230 is cleared for the next use. The mediation packaging module 280 is configured for packaging medication in two ways. Firstly, it can bottle medication, insert sterile bulking material and apply a cap. A cap spinner (not shown) applies a known torque, the removal torque is tested to verify cap function and re-torqued to the original torque setting. A drug pedigree certificate produced by the system adds to the pedigree a “cap good” notation. Secondly, the medication packaging module 280 can load medication into sterile foil seal pouches, apply a foil seal and verify seal via visual inspection. Standard dosage packaging also presents an obstacle for liquid medications, especially paediatric medications and maintenance drugs where dosage can vary 26 widely. To resolve this obstacle the dispensary apparatus 10 of the invention provides a bulk storage container for liquid product 220 with an integrated pouring unit 226 as shown by FIGS. 25A-B. This bulk liquid medication container 220 is operated by the robot to pour a measured amount of medication into liquid dispensing containers (not shown). Some medications require reconstitution generally with another liquid prior to dispensing. A reconstitution bulk storage container 370 is shown in FIGS. 26A-C and includes a mixer/agitator 32 and a liquid/concentrate storage section 34 for adding liquids to concentrates and pass them to a mixing cell for stirring or agitation. Similarly, some medications require mixing of two or more components prior to dispensing. A mixing bulk storage container 380 is shown by FIGS. 27A-B. The mixing container 380 includes liquid storage sections 382, a mixer 384 and mixing valves and piping 386 for measuring and dispensing mixed medication to a liquid dispensing container according to any number and amount of liquid components by weight, volume or percentage. Further, some medications require geometric reduction of one or more components in a carrier. A compounding bulk storage container 390 is shown in FIGS. 28A-B and includes liquid storage sections 391, a mixer 394 and mixing valves and piping 396 for performing geometric reduction of one or more components in a carrier.
  • As previously indicated, each package has to be labelled. It would be of value to have a labelling apparatus and method, which are versatile in the sense of being applicable to such a range of package shapes and sizes. For medicament dispensing kiosks, medicament package labels are typically of a standard shape and size to enable them to be passed through a printer, and must contain critical patient and medication information in conformance with industry standards and offering little scope for variation in shape, size or materials. Such labels are typically applied by running pressure sensitive adhesive back coated labels on a peal-away carrier through a label printer and transferring the printed label to the medicament container such as a bottle or box. Known label transfer methods have used sponges, vacuum, sponges and vacuum in combination, transfer media, transfer roller and pressure pads. There is a need for reliable accurate placement and adhesion of standard flat labels to dispensed medicament products.
  • A package labeling module of the apparatus is shown in FIGS. 10A-H. Referring in detail to FIGS. 10A and 10B, a package labelling unit 510 is shown which has upper and lower labelling modules 512. In normal mode, one of the modules is in use and the other module is redundant pending breakdown or other interruption in operation of the one module. Elements of the labelling modules 512 are mounted on a mounting plate 514. As shown in FIG. 10A, rotatable elements of the labelling module are fixed to pulleys 516 which are mounted on a reverse face of the mounting plate and are driven by bands (not shown) from a motor 518. As shown in FIG. 10C, the labelling unit 512 is mounted within a support frame 520 of a medicament dispensing kiosk. Also mounted in the frame is a pick head 522 of the sort described in copending U.S. patent application Ser. No. 12/503,989, which is herein specifically incorporated by reference.
  • As shown in greater detail in FIG. 10D, each labelling module 512 has a printer 524, label stock 526 wound from a supply reel 528, a take-off reel 530 associated with a tensioner device 532, and the motor 518. The label stock 526 is in the form of a release liner or backing 534, with labels 536 self-adhering to the liner along its length.
  • The labelling module is used to apply a label to a medicament product container or package 538 which is transported to the labelling module 512 using the pick head 522. In use, label stock 526 is pulled off the supply reel 528 by a drive wheel 540 in the printer 524. Within the printer, the label stock is halted and desired medicament identifying data is printed onto a presented label before the printer wheel 540 further advances the label stock 526 in preparation for the printed label 536 to be applied to the container 538. As the label stock 526 exits the printer 524, the printed label 536 continues to adhere to liner 534, and the take-up reel 530 and tensioner device 534 pull the liner around a small diameter roller 544 so as to take up the liner 534 at a rate related to the throughput of the printer 524.
  • The label 536 is made from paper or plastic that is stiffer than the liner 534 to which it adheres on the supply reel 528. This results in the label 536 separating from the liner 534 as a result of its movement around the small diameter roller 544. The label 536 is also sufficiently stiff that it adopts a suspended position as shown in FIG. 10D as it progressively separates from the liner 534. For this purpose, the label 536 is of material that is sufficiently stiff as effectively to prevent the label from sagging under its own weight from edge to edge along its longest side. The label stock 526 advances to a point where about ⅞ of the label length is detached from the liner 534 so that the label is suspended in preparation for a subsequent stage in the labelling process. It will be appreciated that whereas, in this preferred embodiment, the label 536 is of uniform stiffness over its area, in an alternative embodiment, the label can be locally stiffened as, for example, by one or more thicker regions, whereby the stiffness required both for the separation from the liner and for the temporary suspension of the label are achieved.
  • The pick head 522 is then driven to pick a medicament container 538 to be dispensed by the apparatus and to raise the container to a desired level where a platen 548 forming part of the pick head and supporting the container moves in a horizontal direction to bring the container to the position shown in FIG. 10D. At this point, the container is located under the suspended label 536 with a combination of sensors and feedback ensuring that a front edge 550 of the label is aligned with a pre-selected contact start point 552 on the product package.
  • In a subsequent stage of the labelling process, the pick head 522 drives the package upwardly against a conformable cylindrical tamp block 554 of polyurethane foam, this movement acting both to initiate a “tacking” of the self-adhesive label 536 to the package 538 and to dislodge the last part of the suspended label 536 from the liner 534. The medicament container 538, with label attached, is further raised by the pick head 522 to bring the container with the label side up, into contact with a second tamp block 556 formed from conformable polyurethane foam, the second tamp block being shown in FIGS. 10D and FIGS. 10F to 10H. The tamp block 556 is generally of U shape and has a rigid constraining bar 558 mounted to the mounting plate 514 and extending between and fixed to the two uprights of the U.
  • In use, the package container 538 with label 536 tacked to at least a central part of the container surface is brought against a cross-piece 560 of the U tamp block as shown in the operational sequence of FIGS. 10F to 10H. The uprights of the U are anchored by the constraining bar 558 and the cross-piece 560 of the U is relatively thin and flexible. Consequently, when the product container 538 is moved in the direction of arrow A, the relatively thin and flexible U cross-piece firstly conforms to an upper surface 562 of the package container 538 as shown in FIG. 10G so that a part of the label is sandwiched between the cross-piece 560 and the front of the package. Then, in response to further upward movement of the platen 548 in the direction of arrow A, as shown in FIG. 10H, the tamp block 556 is squeezed resulting in U uprights 564 being forced alongside container sides 566. Because the U uprights 564 are prevented from further translational movement, they buckle and fold as shown in FIG. 10H and, in so doing, deform to embrace at least a part of the respective sides of the package container so as to fold the label edges into adhering contact with both the sides 66 and corners 568.
  • Dimensions and materials are selected so as to direct pressure to contact the label to all intended parts of the package and to apply sufficient pressure to activate the contact sensitive adhesive. Because the size and shape of the package are known to the pick head control means, accurate label placement is possible with this method, with high reliability and repeatability.
  • It will be appreciated that the first and second tamp blocks, 54 and 56 respectively, can be combined if desired, whereby a first part of the movement of the container 38 relative to the combination tamp block is to tack the label 36 to the package, and then a subsequent part of the movement is to effect the label wrapping and application described previously. It will be appreciated also that alternatives to the U form of tamp block are possible. Thus O-form and H-form blocks can, for example, be configured to provide the relative translational movement and the block deformation to apply the label to the front and sides of a package.
  • In addition, while, conveniently, the tamp block is formed of a single cut or moulded piece of material, the parts of the tamp block that are used respectively for the front tamp and the side tamp can be separate but joined by a mechanical articulation. It will be appreciated that in the preferred embodiment, the movement of the product container relative to the tamp block to apply an adherent label to the front and sides of a package is a single unidirectional movement of the container. However, the movement can alternatively be affected as intermittent actions. For example, a first translational movement of the tamp block or container to apply a label to the front of the package can be followed by a second movement where a combination of translational movement and twisting are used to apply parts of the label against the side walls.
  • In addition, it will be realized that the movement need not be unidirectional in nature. In a further alternative arrangement, the tamp block is moved while the product container, is maintained in a fixed position for the label application, or both the tamp block and the container are moved to effect the label application. It will be further appreciated that whereas the nature of the deformation of the tamp block to effect the pressure against the sides of the container occurs by the tamp block being squeezed between a clamping fixture at one side of the tamp block and the medicament package at the other side of the tamp block, other external fixtures can be positioned so as to limit the locations into which parts of the tamp block can be deformed to those required for the effective application of the label where required on the container and to the effective application of pressure at the contact locations.
  • The apparatus 10 can include a further improvement for product labeling in the form of an optical scribe 330 that writes directly to a product package (container) to be dispensed. FIG. 11 shows a laser marking module 330 directly marking (labeling) a product container 335 positioned on the robot's pick head 50. By the addition of a light sensitive coating on the container 335 the laser marking module 330 writes readable information directly onto the container 335 without the requirement for a transfer label and the associated complications of label transfer, placement and adhesion. Loading a dispensary apparatus with medication is a time consuming, tedious, laborious, highly repetitious task, and as a result, is subject to error. Removal of these human factors at the loading point is important for reducing errors in a drug supply chain. The known loading methods have relied on RFID tags to verify the drug, requiring a human operator to flash each product against an RFID sensor which verifies the drug and identifies (e.g. by a light) the appropriate storage slot to direct the operator to the location of correct placement. Apparatus using such known methods display, on an inside screen, a picture of the drug with data, DIN, lot, etc., and then says the name of the drug using a text speech generator. The downfall of those prior methods and apparatus is the amount of time required to verify each product, and the additional cost in the apparatus of an the indicator light system with related software and hardware to drive the lights, in addition to the cost of an RFID tag in each and every product. The dispensary apparatus 10 of the invention uses either an RFID tag, if any, or the optical product coding which is already in place on pre-packaged product, which is read by the robot and used by the robot to automatically place the products in inventory in the apparatus, without requiring an operator to open the machine. The robot and the networked computer system then know, with absolute certainty, the location of all products in the machine and the state of the inventory, without the possibility of human placement error. Product loading occurs in two modes. Firstly, the apparatus provides means for manual loading of product by an operator, after the operator has passed a security test to place the apparatus in a manual load mode. Product is placed in a manual load slot 350 for robotic self-load as shown in FIG. 12. When product is manually placed in the load slot 350 it is accepted by the robot, read and placed in inventory in the apparatus. The cycle completes until inventory storage of the product load is complete. Secondly, the apparatus provides means for automatic loading of product as shown by FIGS. 13A-B. A secure transfer container 360 is used for secure transport of drugs and automated loading into the apparatus. In the automatic load mode, the operator places the secure transfer container 360 into the apparatus in a receiving port and the control system 100 automatically loads the products into inventory while not required for other tasks. When full loaded, the empty secure transfer container 360 is used for receiving waste to be returned from the apparatus to the distribution center so the transfer container 360 also serves as a waste container 115 in this mode. The secure transfer container is shown in FIGS. 14A-D and is configured on the basis of its contents, with several types being provided including a refrigerated type, a non-refrigerated type, a pre-packaged product type, a bulk liquid type and a bulk pill type. A universal type secure transfer container 360 is also provided. The refrigerated type secure transfer container 365 is shown in FIGS. 22A-B. It is insulated and refrigerated with an external power supply hook up 368 to provide active refrigeration during transport or storage on route, and it contains a Peltier effect type solid state cooling device 366 and a temperature monitoring system. The secure transfer container 360 is a secure device that can only be opened by the robot once it is inside the apparatus or at the distribution center and provides a secure transfer vessel for the drug products as they travel between the apparatus and the distribution center, whereby a common carrier may be used for transporting the products. As stated, a measure of utility for the apparatus is that a drug requested by a user must be available from the apparatus from which it is requested. A back end drug vault module 200 of the apparatus 10 has a fixed number of storage slots 207 for product. As shown by FIGS. 15A-d, each storage slot 207 can store up to five units of the same product SKU. In locations such as a busy primary care clinic or hospital emergency room, this may not be adequate storage to meet the demand for high demand medications to be in stock all of the time with a reasonable restocking cycle time, making it possible to run out of a high demand medications before the next restocking visit, especially during epidemic seasons or events. In such locations, multiple modules of the apparatus can be co-located to duplicate or multiply the number of user interfaces present, allowing more than one patient to be served at a time. Further, the apparatus 10 is configured to allow for the inventory product of one drug vault module 200 to be picked and securely transferred by a control system 100 to another co-located drug vault module 200. A patient may be served by a first apparatus 10 for which some components of the medication requested may be out of stock within that apparatus but available and in stock at a second apparatus 10. The first apparatus 10 queries the second apparatus 10 for availability, if the product is available, the first apparatus requests a secure transfer of the medication. The robot of the second apparatus is instructed to carry out a product pick, scan and verification that the product is correct, then deliver it to a left or right side secure transfer slot of the apparatus (not shown). The robot of the first apparatus travels to a right or left side secure transfer slot of that apparatus and, when in correct position, a transfer order handshake is exchanged between the first and second apparatus, allowing the transfer ports to open and the requested product to be passed from a platen of the robot of the second apparatus to a receiving platen of the robot of the first apparatus. After the transfer is complete, the second apparatus retracts its robot platen, verifies that the transfer was completed and closes its transfer door. The robot of the first apparatus verifies the product received, confirms identity of the product against the drug record, and continues the dispense cycle in the same manner as if the drug had been located within the drug vault module of the first apparatus. Multiple apparatus 20 can be co-located, for example in a three apparatus colocation installation, a first apparatus can request medications from the third apparatus whereby the second apparatus is instructed to act as an intermediary and pass the medication through that apparatus. Further, from the user's perspective of utility, there is no such thing as an obscure medication. If a medication has been prescribed, it is what is wanted and needed immediately to commence healing. The user does not accept that a particular medication it needs is rarely sold, so seldom stocked. To the patient, the utility value of the dispensary apparatus is its ability to dispense the medication needed as and when requested. For example, there are many medications for tropical diseases that are necessary, but dispensed infrequently. The apparatus 10 of the invention applies a method with enabling hardware and software to designate specific storage slots 207 as multiple product SKU garages. The slots 207 are vertically oriented, and operated on a first in-first out inventory control rule. This is accomplished by picking product from the bottom of the slot and placing new product on the top of the slot. In a garage-type designated slot containing five different individual product SKU's, the desired product may be the third product in the slot. The robot travels to the slot location and picks item one, picking from the bottom. The robot returns item one to the top of the same slot for restocking. The robot returns to pick item two, again returning it for restocking. The robot then picks item three, the desired item, verifies it and proceeds to a dispensary preparation cycle. The system's product inventory location register is corrected to show that former product one is now in position three, that former product two is now in position four, that former product three is now in position one and that former product four is now in position two, with the slot able to accept one additional product SKU on restock. The refrigerated storage module 250 of the apparatus 10 is shown by FIGS. 19A-B, FIG. 20 and FIG. 21. It has an insulated perimeter and an insulated, sliding door 252 which can be opened in a low clearance environment by means of a sliding mechanism or track such that it opens to expose its internal contents to the robot, and moves out of the way on a plane perpendicular to the X-Y axis of motion of the robot pick head 50. Its track has a shape or the door has a mechanism whereby the door is sealed at the perimeter when closed, and moves away from the seal, or the seal collapses or moves away to provide clearance for the door to operate. The door is operated by a linear actuator, pulley, cable, cogged belt system, or by a latch that can be engaged by the robot head to open and close the door. The refrigerated storage module 250 also communicates to an external vacuum pump 258 (or may contain a pump), capable of providing a reduction in barometric pressure within the refrigerated storage cell immediately after the door is closed, to set the door seal and to remove ambient air and moisture that was introduced into the refrigerated storage module while open. The refrigerated storage module 250 contains Peltier effect type solid state cooling devices coupled to heat absorbing aluminum thermo sink arrays to remove heat from within the refrigerated module without the requirement for a compressor, condenser and evaporator.
  • It will be understood that in dispensing inventory pre-packaged products and inventory bulk medicament in such a way as to have a high first script ratio, a prevailing problem is the corresponding demand for a kiosk which has a high volume/footprint to accommodate a wide variety of medicaments, a wide variety of dispensing methods and a wide range of amount dispensing capabilities. It will be appreciated that the networked arrangement according to one aspect of the invention permits certain of these activities to be conducted at a location remote from the kiosk which permits some reduction in volume/footprint of the kiosk. In addition, in the control system for medicament products containing dispensed bulk medicaments (either pill type medicaments or liquid medicaments) and for dispensing pre-packaged products, the kiosk volume and footprint is reduced by having certain elements of the control system commonly used in multiple stages of the dispensing process. This means that the dispensing of the wide variety of medicaments, by a wide variety of dispensing methods to achieve a wide range of dispensed amounts does not mandate a tailored plurality of control sub-systems.

Claims (15)

1. Apparatus for delivering medicaments to users, the apparatus comprising a drug vault having a pre-packaged product storage container for containing pre-packaged medicament product, a bulk product storage container for containing bulk form medicament, and a control system operable to effect at least a part of a process to dispense bulk form medicament from the bulk product storage container, to pack as a dispensed packaged medicament product the dispensed bulk form medicament, and to pick and deliver medicament products to a delivery zone.
2. Apparatus as claimed in claim 1, wherein at least a part of the control system is commonly deployed in handling both the pre-packaged medicament products and the dispensed packaged medicament products.
3. Apparatus as claimed in claim 1, wherein the control system includes a medicament packaging module operable to dispense and package the bulk form medicament as a dispensed packaged medicament product that is one of a bottle, a box and a foil package.
4. Apparatus as claimed in claim 1, further comprising a metering module operable to meter a selected amount of the bulk form medicament and to deliver the selected amount from the bulk product storage container.
5. Apparatus as claimed in claim 4, wherein the bulk form medicament is stored as individually dispensable items, and the metering module is operable to meter the selected amount of the bulk form medicament as a metered plurality of individually dispensable items.
6. Apparatus as claimed in claim 5, wherein the metering module further includes a singulator mechanism successively to take items of the individually dispensable items and to deliver the taken items for packing, and a counter to count the number of items taken from the individually dispensable items in bulk form and delivered for packing.
7. Apparatus as claimed in claim 6, wherein the individually dispensable items are one or more of pills, lozenges and capsules.
8. Apparatus as claimed in claim 1, wherein the bulk form medicament is stored in the bulk product storage container as a liquid.
9. Apparatus as claimed in claim 8, further comprising a metering module operable to meter the bulk form medicament as a metered volume of the liquid.
10. Apparatus as claimed in claim 8, the bulk storage container located within a refrigerated zone whereby liquid medicament stored therein is maintained at a lowered temperature to prevent heat-induced deterioration thereof.
11. Apparatus as claimed in claim 1, further comprising a treatment mechanism operable to alter the bulk form medicament from an inventory state to a dispensing state prior to the bulk form medicament being dispensed and packaged as the dispensed packaged medicament product.
12. Apparatus as claimed in claim 11, the treatment mechanism operable to effect at least one of mixing, agitating and diluting of the bulk form medicament product.
13. Apparatus as claimed in claim 1, further comprising a user-interface module configured to receive prescription information input from a user, a control module to interpret the prescription information and to issue commands to the control system on the basis of the received prescription information, thereby to cause the control system to select between picking and delivering the pre-packaged medicament product to a delivery zone, and picking and delivering the dispensed medicament product to the delivery zone.
14. Apparatus as claimed in claim 13, further comprising a network interface for connection of the apparatus into a network, the network interface operable to transmit state of the apparatus information onto the network and operable to receive command information from the network for control of the control system.
15. Apparatus as claimed in claim 13, wherein the drug vault is configured for secure storage of the medicaments, and is connected to the user-interface module, with the user-interface forming a front end of the apparatus and the drug vault forming a back end of the apparatus.
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