HK1151965A - Automated apparatus for dispensing medicaments - Google Patents

Description

Automatic device for dispensing a medicament

Technical Field

The present invention relates to apparatus for dispensing medication, such as vending machines, and more particularly to an automated apparatus for delivering medication to a patient/user, the apparatus being adapted to be located at a site remote from but connected to a pharmacy support site.

Background

In this specification, the term "medication" encompasses a drug product as well as any and all other materials dispensed according to a presented prescription. Traditional means of dispensing prescription drugs include a doctor meeting a patient and prescribing a prescription based on a particular diagnosis, followed by handwriting and signing the prescription, which the patient then takes to a pharmacist at the pharmacy for dispensing. In recent years, two significant advances have occurred in the area of drug dispensing. A first advancement is an electronic prescription collection method, system and apparatus that increases overall accuracy and improves patient record to prescription correlation. A second advance is the advent of automated equipment that can automatically dispense medication, typically configured as vending machines, located at a convenient patient access location (e.g., in a doctor's office or medical clinic), and networked with a central computer system for inventory control and management. In this regard, reference may be made to PCT application PCT/CA2007/001220 (published as WO2008/006203 on 17.1.2008) relating to a method, system and apparatus for dispensing a pharmaceutical product, which is specifically incorporated herein by reference.

More specifically, PCT application PCT/CA2007/001220 describes a networked system having: a server; a patient information database linked to the server; a first client having an input device linked to a server and operable to generate a prescription of a medication for administration to a user; a second client comprising an automatic device for dispensing a medicament (referred to in the PCT application as a robotic prescription dispenser), the automatic device being operable to identify a human and/or machine readable description in a prescription and to provide verification of cross-reference between the description and patient information as a start for dispensing a medicament to a user based on an input prescription. The physician in the clinic may be a third client with an input device linked to the server to enter the appropriate prescription information, or to accept certain prescription information from the database that is applicable to a particular patient in a particular situation. Further, the doctor's client device may be operable to display patient information, such as medication history, insurance coverage, etc., and the printer module may print the prescription as a paper printout.

The server and database allow for the storage, compilation and retrieval of patient data including name, address, and diagnostic and drug history. Both the doctor and the automated device for dispensing the medication may access the database via a server, via a secure connection or via a link between the system and an existing clinic management system or patient database of the clinic.

PCT application PCT/CA2007/001220 also describes a user interface, a teleconferencing or video conferencing arrangement that allows communication between a user and a verifier subject (human agent), and a scanning arrangement for capturing images of a prescription so that the verifier subject (e.g. a licensed pharmacist communicating with a device located remotely from the device in the system) can view the prescription as required to approve the prescription. The user interface of the dispenser apparatus provides a detailed and clear illustration to guide the user.

The 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 with the patient's answer to identify the patient and cross-referencing this information with patient information stored on a networked database. Once the patient is identified, the dispenser device prompts the user for a prescription and the device processes the prescription input by the user either by verifying the person's body as described above or by processing a machine readable description (which may be a bar code). This information can be checked by the server and the database. The device may also interface with the server to adjudicate insurance claims and determine the amount due by the patient. The patient accepts or rejects the transaction. If the transaction is accepted, the device interfaces with the server to process payment, for example, by prompting the patient to enter credit card information. The prescription label and receipt are printed. The device confirms that the medication is correct and delivers it to the dispensing area for retrieval by the user while leaving the prescription in the lock box and verifying that the purchased pharmaceutical product has been retrieved. Further, the device may print and/or provide the user with user guidance material relating to the particular prescription medication it dispenses to the user.

The medication dispensing vending machine may be located in a doctor's office or clinic as described in PCT application PCT/CA 2007/001220. The interaction between the patient and the vending machine user interface is linked to various networked function devices so that the patient can obtain the prescribed medication without having to go to a pharmacy or drug store.

However, the use of such known medication dispensing apparatus has so far been limited to a limited variety of medications that can be stored remotely or dispensed by a robot. Therefore, patients, especially patients requiring non-standard doses, multiple medications, requiring special storage or some form of pre-dispensing preparation of medications, are often faced with the inability to meet their medication requirements with such known devices, thereby requiring a trip to the pharmacy to make use of the prescription and therefore, the inability to make use of such dispensing devices.

In such a medicament dispensing machine, it is desirable that the first formulation is relatively high; that is, a user presenting a prescription for obtaining medication will be able to fill their prescription as much as possible at the vending machine without having to go to the pharmacy.

The first prescription coverage ratio actually varies depending on how many kinds of prescriptions are to be presented at the vending machine and on the range of medicines available at the vending machine. With respect to the range of medicaments, this ratio can be increased by increasing the variety of different medicaments that can be dispensed at the vending machine. For example, if there are pills for suppression of headache and pills of a different nature for relief of rheumatalgia, the first prescription coverage is higher than if there were only one or the other of the headache pills and the rheumatalgia pills. Similarly, if there are multiple drug delivery mode capabilities, such as pill delivery and liquid delivery, the first prescription rate is likely to be higher than if there were only one drug delivery mode capability. Also if there are multiple number dispensing capacities, for example the capacity to dispense any number of pills between 1 and 50, the first prescription rate is likely to be higher than if there were only a single pill dispensing capacity fixed at 20 pills, for example.

Obviously, if the vending machine is configured to dispense every conceivable medicament, with every conceivable delivery capability and with every conceivable quantity dispensing capability, the first prescription rate may approach 100%. However, if the cost and complexity of the product and operation also increases significantly, increasing the vending machine capacity in this manner results in a reduced return. In addition, adding these capabilities in this manner to significantly increase the size or footprint of the vending machine presents further expense and logistical problems in the sense that convenient and price competitive locations for such vending machines are readily available.

In view of these and other user requirements or preferences on the market, an improved automated device for dispensing medication is desired.

Disclosure of Invention

According to an aspect of the present invention, there is provided a device for delivering a medicament to a user, the device comprising: a medicine storage compartment having a pre-packaged product storage container for containing a pre-packaged pharmaceutical product; a bulk product storage container for containing a medicament in bulk form; and a control system operable to effect at least a portion of the process of dispensing the bulk form medicament from the bulk product storage container, packaging the dispensed bulk form medicament as a dispensed packaged medicament product, and picking up and delivering the medicament product to the delivery area. Preferably, at least a portion of the control system is collectively configured to manipulate both the pre-packaged drug product and the dispensed packaged drug product, thereby limiting the volume and footprint of the device.

Preferably, the control system comprises a medication packaging module operable to dispense and package bulk form medication as a dispensed packaged medication product, the dispensed packaged medication product being one of a bottle, a box and a foil package. The apparatus may further include a metering module operable to meter a selected amount of the bulk form medicament and deliver the selected amount from the bulk product storage container.

The pharmaceutical product may be stored in bulk form as individual dispensable items, the metering module being operable to meter a selected amount of the bulk form medicament as a metered plurality of the individual dispensable items. The metering mechanism may also include a sorter (singulator) that successively takes items of individually dispensable items and conveys the taken items for packaging, and a counter that counts the amount of items taken from individually dispensable items and conveyed for packaging. Typically, the individually dispensable articles are one or more of pills, lozenges and capsules.

The bulk form medicament may alternatively or additionally be stored as a liquid in a bulk product storage container. With such an arrangement, an alternative or additional metering mechanism is included which is operable to meter the bulk form of the medicament as a metered volume of liquid. For certain liquid medicaments, the bulk storage container may be within a refrigerated area whereby the liquid medicaments stored therein are maintained at a reduced temperature to prevent their heat-induced deterioration.

The apparatus may further comprise a processing mechanism operable to change the bulk form of the medicament from the stock state to the dispensing state before the bulk form of the medicament is dispensed and packaged as a dispensed packaged medicament product. For example, the processing mechanism may be operable to effect at least one of mixing, reconstituting, agitating, and diluting the bulk form of the medicament.

Preferably, the apparatus further comprises: a user interface module configured to receive prescription information input from a user; a control module that interprets the prescription information and issues commands to the control system based on the received prescription information, thereby causing the control system to select between picking up the prepackaged pharmaceutical product and delivering the prepackaged pharmaceutical product to the delivery area and picking up the dispensed pharmaceutical product and delivering the dispensed pharmaceutical product to the delivery area. The device may further comprise a network interface for connecting the device into a network, the network interface being operable to transmit a status of the device information onto the network and operable to receive command information from the network for control of the system.

The drug repository may be configured for the secure storage of drugs for hand and is connected to the user interface module, which forms the front end of the device and the drug repository forms the back end of the device.

The apparatus may further comprise a product marking module configured for storing a library of labels and for marking pharmaceutical products to be dispensed by the apparatus, the product marking module being operable to suspend a label from the library of labels and having an applicator for applying the label to a pharmaceutical product, the control system being operable to transfer the pharmaceutical product to the suspended label and align a leading edge of the label with a predetermined point of contact initiation on the pharmaceutical product.

The device may further comprise a verification unit operable within the network to verify the drug product, the control system being configurable to present the drug product to the verification unit for verification of the delivered product. For example, the verification unit may be operable to implement one or more of the following: weighing the pharmaceutical product presented to it, monitoring the barcode on the pharmaceutical product presented to it, and recording the image of the pharmaceutical product presented to it.

Preferably, the automatic device communicates with a remote server linking the device to a computer network, the device having an identification unit for reading and identifying a prescription of a prescribed medication for a user of the device. The device is preferably configured to receive information about users, medications, and/or other devices of the network over a computer network.

The control system may be configured for communication in a network and may include means for accessing the user interface module and the drug repository module, the access means including a plurality of sensors for providing location feedback information to the control system for controlling the access means, picking up a drug from the drug repository module and delivering the drug to the user interface module for delivery to a user. The user interface module and the drug repository module are preferably sized for interconnectivity of a plurality of user interface modules and drug repository modules in a variety of combinations. Preferably, the control system further comprises a state machine configured to use a state table comprising states for controlling the control system, the states being associated with the position feedback information provided by the sensors and being based on actions to be applied by the access device to pick up a medication from inventory in the drug repository module. The control system may apply behavior according to increasing levels of aggressiveness (aggregate) to achieve success in picking up medications from inventory, where success is primarily defined as congestion without the need for a control system.

The network may be a neural network comprising a dynamic knowledge base of information of the control system in the network for picking up drugs from inventory, the information comprising learned information about drugs in inventory and ongoing actions in the device and their results, and the computer controlled control system may use the knowledge base information to control the access means.

The user interface module is preferably configured for hierarchical security level access by the operator, whereby a first security level access is restricted to access only a preselected portion of the front end user interface module, and a second security level access comprises access according to the first security level access and access control system and the drug vault module including its inventory.

The drug storage room may include a refrigerated storage module for storing drugs in inventory in a controlled refrigerated environment, the refrigerated storage module having one or more temperature sensors for monitoring the refrigerated environment, and the device communicating information from the temperature sensor(s) over a network for centralized processing.

A secure transfer container may be provided for securely transferring the pharmaceutical product therein from the pharmaceutical dispensing center to an automated device. The secure transfer container may be configured for receipt by the control system and self-loading of the pharmaceutical product from the secure transfer container by the control system to place the pharmaceutical product into inventory in the drug vault module. The secure transfer container is configured to restrict access to the pharmaceutical product therein to only the dispensing center and the control system, whereby a common carrier may be used to transport the secure transfer container. The secure transfer container may be isolated and refrigerated, include a solid state cooling device and means for temperature monitoring and configured for being powered by means of an external power source.

According to another aspect of the present invention there is provided a method of configuring a medication dispensing vending machine for use in dispensing a prescribed predetermined group of prescriptions, the method comprising storing at the medication dispensing vending machine a first plurality of medications selected from a first larger set of medications, installing at the medication dispensing vending machine a second plurality of medication delivery mode capabilities selected from a second larger set of medication delivery mode capabilities, and selecting a first combination of the first plurality of medications and the second plurality of medication delivery mode capabilities such that the first combination can satisfy at least a first predetermined portion of the prescribed predetermined group of prescriptions.

The configuration method may further include providing a third plurality of quantity dispensing capabilities selected from a third, larger set of quantity dispensing capabilities at the medication dispensing vending machine, the method further including selecting a second combination of the first plurality of medications, the second plurality of medication delivery mode capabilities, and the third plurality of quantity dispensing capabilities such that the second combination of the first plurality of medications, the second plurality of medication delivery mode capabilities, and the third plurality of medication quantity dispensing capabilities may satisfy at least a second predetermined portion of the prescribed group.

Drawings

The description of certain embodiments of the present invention is provided herein by way of example only with reference to the accompanying drawings in which like reference numerals refer to like elements throughout the description:

FIG. 1 illustrates a front view of one embodiment of an automated device for dispensing medication in accordance with the present invention, showing two side-by-side front end user interface modules;

FIG. 2 illustrates one example of a z-axis pick-up head assembly of the automated apparatus of the present invention with product position and z-axis position sensors for determining the machine state of the apparatus;

FIGS. 3A-C illustrate an example of a control system of the apparatus of the present invention with a robotically accessible waste container for placing and storing suspicious or damaged drugs, where FIG. 3A is a front view of an example of a rear drug storage chamber module with a control system therein, FIG. 3B is a perspective and larger scale detail of the control system portion of FIG. 3A, and FIG. 3C is a top cross-sectional view of the control system of FIG. 3A taken at section B-B;

FIG. 4 illustrates a front view of one example of an internal configuration of a back-end drug storage compartment module of the automated device of the present invention, showing a plurality of networked cameras in position within the device;

fig. 5A-5B are perspective views of the front-end user interface module of one embodiment of the automation device of fig. 1, and fig. 5C shows an open device, together with an added level of security of the access device: FIG. 5A shows a first level of access security in which the front of the device is held closed to require software control function access for loading inventory, no physical access device is provided; 5B1-5B3 illustrate a second level of access security in which the front of the device may be opened by controlling access to obtain access to the user interface portion of the device and the portion of the device under which services are accessible; and fig. 5C shows a third level of access security in which the rear drug storage compartment module of the device containing the drug is opened;

FIG. 6 illustrates a front view of one example of a rear drug storage compartment module of the automated apparatus of the present invention with a controlled room temperature top portion and a controlled refrigerated bottom portion;

FIG. 7 illustrates one example of a pill counting module integrated into a bulk storage container for pill/capsule products for counting pills to be dispensed by the apparatus of the present invention;

fig. 8A-B show an example of a packaging module of the automatic apparatus of the invention for packaging a pharmaceutical product to be dispensed to a user in a bottle or foil package, wherein fig. 8A is a perspective view and fig. 8B is a front view thereof;

figures 9A-9B illustrate one example of a drug storage module of an automated device of the present invention showing a plurality of standard slots for receiving bulk storage cassettes therein, and a typical bulk storage cassette in one such slot for retrieval by a robot of the device and transfer to a packaging module, wherein figure 9A is a perspective view thereof and figure 9B is a greater scale detail of portion a of figure 9A;

FIGS. 10A-F illustrate a package marking module of the automated apparatus of the present invention, wherein FIG. 10A illustrates a top view of its marking assembly; FIG. 10B shows a perspective view of the marker assembly of FIG. 10A, FIG. 10C is a detail view on a larger scale of an exploded view of region C of FIG. 10A, FIG. 10D is a cross-sectional view taken at line D-D of FIG. 10C, FIG. 10E is a cross-sectional view taken at line A-A of FIG. 10A and FIG. 10F is a cross-sectional view taken at line B-B of FIG. 10A;

FIG. 11 illustrates a laser marking module of the automated apparatus of the present invention configured for marking label information directly onto packaging to be dispensed to a user by the apparatus;

FIG. 12 illustrates a front end user interface module according to one embodiment of the invention. The module having a manual product loading slot for manual loading of product whereby product is transferred to the control system, automatic self-loading of product into the drug storage compartment by the control system of the apparatus;

FIG. 13A is a perspective view of an automated apparatus according to one embodiment of the present invention, showing automated self-loading of a conveyed secure transfer container, and FIG. 13B is a detail view of region A of FIG. 13A on a larger scale;

FIGS. 14A-D illustrate one example of a secure transfer container for the robotic device of FIG. 13A, where FIG. 14A is a perspective view, FIG. 14B is a right side view, FIG. 14C is a left side view and FIG. 14D is a top view thereof;

15A-D illustrate a multi-slot, storage container rack of one embodiment of an automated apparatus, the rack having a plurality of standard slots for receiving bulk storage containers therein, showing one slot for receiving five bulk storage containers, each container storing a different pharmaceutical product, wherein FIG. 15A is a perspective view, FIG. 15B is a top view, FIG. 15C is a front view and FIG. 15D is a side view;

FIG. 16 shows a perspective view of one embodiment of an automated apparatus for dispensing medication in accordance with the present invention in which two side-by-side front end user interface modules share a rear drug storage compartment module;

FIG. 17 illustrates a perspective view of another embodiment of an automated apparatus for dispensing medication according to the present invention comprising four side-by-side front user interface modules and two back-end drug storage compartment modules, whereby each two side-by-side front modules share a back-end drug storage compartment module;

FIG. 18 illustrates an exemplary subassembly of two interconnected back-end drug storage compartment modules of the automated apparatus of the present invention;

FIG. 19A shows a front view of one example of a refrigerated storage module of the automated equipment of the present invention with cooling equipment, isolation slide doors, a locking unit and an air purge provided by a dehumidifier and pressure control unit, and FIG. 19B shows a perspective view of the exemplary module;

FIG. 20 shows a side view of the module of FIG. 19A;

FIG. 21 shows a top view of the module of FIG. 19A;

FIGS. 22A-B illustrate one example of a refrigerated safety transfer container for use with the automated apparatus of the present invention; wherein FIG. 22A shows a front view and FIG. 22B shows a side view thereof;

figures 23A-C illustrate one example of a bulk storage container of pre-packaged products of the automated apparatus of the present invention (one such container is shown installed in the apparatus of figure 9), wherein figure 23A shows a perspective view, figure 23B shows a side view and figure 23C shows a front view thereof;

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;

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 therewith, wherein FIG. 24C is a top view, FIG. 24D is a top and side perspective view, FIG. 24E is a view taken on line B-B of FIG. 24H, FIG. 24F is a front view, FIG. 24G is a side view and FIG. 24H is a vertical cross-sectional view on line A-A of FIG. 24F;

25A-B illustrate one example of a bulk storage container for storing a liquid medicament and having an integrated liquid pouring unit, wherein FIG. 25A is a front view and FIG. 24B is a side view thereof;

figures 26A-C illustrate one example of a reconstitution bulk storage container for storing a liquid medicament and reconstituting the medicament with another liquid prior to dispensing, wherein figure 26A is a front view, figure 26B is a side view and figure 26C is a perspective view thereof;

27A-B illustrate one example of a mixing bulk storage container for storing a plurality of 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

28A-B illustrate one example of a blending bulk storage container for storing a plurality of different liquids and blending and mixing prior to dispensing for carrier geometric reconstitution, where FIG. 28A is a front view and FIG. 28B is a side view thereof.

Detailed Description

The present invention provides an automated device for dispensing medication that advantageously provides improved utility for expanding the variety of medications that can be stored, prepared and dispensed. The utility of the automated device is enhanced by increasing the prescription coverage provided to the patient at the autonomous network device or drug dispensing device. This utility of the services provided by the device can be from the perspective of a patient (i.e., user) who is standing in the doctor's office, holding a prescription, and needs medication immediately. The distance the patient must travel and the resistance the patient must overcome to get the drug are the patient's utility function. From the point of view of the medication dispensing machine (whether it is a pharmacy or a remote dispensing device as provided by the present invention), utility represents how many items on the patient's prescription can be met without requiring secondary actions, such as ordering requiring the patient to return picked up medications, or to deliver medications to the patient at a later time. Thus, for the medication dispensing machine and the patient, the maximum utility is determined by the ability to dispense all of the required medication on site at the time of initial interaction.

Advantageously, the dispensing apparatus 10 of the present invention is made up of a preselected number and functional types of modular sections (hereinafter generally referred to as modules). These modules include a front-end user interface module 20 (see fig. 1, which shows two such modules positioned side-by-side), a back-end drug storage compartment module 200 in which drugs are stored for dispensing, and a control system 100 (see fig. 3A-C) positioned to operate both the front-end and back-end modules. These modules are sized for assembly in various combinations to meet the needs of a particular application, and their internal components are sized and shaped to meet the grid configuration to allow such compatibility and interconnectivity so that various combinations of modules may be assembled and interchanged as desired. This allows an unlimited combination of inventory configurations from interchangeable, compatible modules and allows the device to accommodate a wide variety of requirements for a given application.

The front end user interface module 20 is provided as a half-size and full-size module to allow, for example, one large and two small user front ends to be attached to the back end of the 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 alternative configurations may be assembled as needed to accommodate product inventory. For example, any combination of product storage modules may be selected within the back end module 200. The controlled room temperature part 240 may be included with the refrigerating temperature storage part 250, as shown in fig. 6. The plurality of storage container bays 205 may hold any combination of product storage modules, as shown in fig. 6, including a product storage container 210 for prepackaged products, a bulk drug storage container 220 for liquid products, and a bulk drug storage container 230 for pill/capsule products. If desired, a reconstitution, mixing and/or blending bulk drug storage container 370, 380, 390 may be added in place of the refrigerated storage container 250 or assembled into the second back end module 200.

The modularity of the various parts of the device is defined in a standardized way, thereby specifying dimensions, critical contact points, power, network configuration points and mechanical features, ensuring interoperability of all components and their associated software, hardware and operating parameters.

Front-end user interface modules 20 are independent of back-end drug storage compartment modules 200, so that they may be co-located in a single cabinet as a unified device, or appropriately multi-located to meet specific service location requirements. More generally, multiple front-end modules 20 are co-located with a single back-end module 200 and two front ends (or multiple front ends) are serviced by a single control system 100 and back-end drug repository module 200. This is illustrated in fig. 16 and 17, where fig. 16 shows two side-by-side front end user interface modules sharing a back end drug storage compartment module, and fig. 17 shows four side-by-side front end user interface modules and two back end drug storage compartment modules, whereby each two side-by-side front end modules share a back end drug storage compartment module. Multiple back-ends may also be linked to extend storage capacity to service the front-end user interface group. Fig. 18 shows a subassembly of two interconnected back-end drug storage compartment modules. A further configuration that may be desirable for serving remote communities with low volume transactions and long time between inventory replenishment is where multiple back-end modules 200 serve a single front-end module 20.

The control system 100 is modified to provide, among other things, reliability of dispensing of pre-packaged pharmaceuticals having a variety of sizes, shapes, weights and weight distributions (e.g., heavy density glass bottles on one side of the package and light dropper on the other side resulting in uneven weight distribution of the package), smoothness of the package, tags (tabs), viscosity, humidity (e.g., absorbed by cardboard), all of which cause a variety of operational problems for robotic systems. Moreover, pharmaceutical companies often change packages, so the control algorithm may become ineffective if the packages change such that the SKU (stock keeping unit) that can be used by the robot to identify the packages changes. Therefore, the robot control algorithm that specifies the method of operation based on the pre-recorded product packaging information (weight, size, etc.) is erroneous simply because the packaging is not intended for an automated dispensing machine and there are currently more than four thousand packaging changes for common medications, which vary by region, manufacturer, repackager, or distributor. To try to address this problem, some known systems produce consistent over-packaging to improve robotic dispenser reliability, but this adds additional operations and expense to the dispenser process, significantly increases the chance of error, and over-packaging is known to place additional waste stream burdens on the product.

The control system 100 overcomes the aforementioned problems of the prior art by using a "state machine" based on control, behavior, and sensors on the robotic pick-up head 50 (see fig. 2). Current medication packages are typically designed for handling by humans, rather than automated or robotic machines.

A person can immediately and intuitively compensate for changes, alterations, and anomalies. While machines such as robotic dispensers are not intelligent and require a refined set of behaviors to compensate for common anomalies. As shown in fig. 4, several networked cameras 150 are mounted inside the device 10 to observe what is happening in the device, and this visual information is used by the control system 100 and, if desired, remotely by the human subject. To compensate for the fact that machines other than humans do not intuitively compensate for gripping articles, the control system 100 is computer controlled by a state machine (which is firmware), associated software, and z-axis encoder 80 (for position feedback control) to react to what is happening and read the values of various sensors, including the product position sensor 60 and the z-axis position sensor 70. For example, if a drug being picked up from inventory by the control system 100 is fully registered to be positioned behind the platform of the pick head assembly 50, the control system 100 knows that this is a successful pick and the tractor of the assembly can then correctly retrieve the drug. The computer of the control system 100 knows the length of the product and therefore the module determines from the sensors 60, 70 (which are simple beam sensors) where the product should be located. The array of sensors 60, 70 enables the control system 100 to determine what state the product is in at any given instant in time. Control system 100 operates to pick up product from back-end drug storage room module 200, for example, by using a "state table" of approximately 385 states (each state acting as a rule).

The dispensing apparatus 10 is provided with intelligence to resolve the problem by the pick-up head sensors 60, 70, product information, machine status, behavior and behavior results. The states are determined from the sensors and product knowledge, the determination of the states results in the selection of actions, the actions are performed in the order of success and for a particular state, the success of the actions adds intelligence (learned knowledge) to the device and system.

The hardware of the control system 100 operates at a first level of control, while the state machine operates at a second level. The hardware includes a collection of behaviors including shake pick (jiggle pick), shelf recovery (shelf recovery), and others. The state machine drives the behavior to be applied by the robot and provides scores for a series of states. The states know whether one state is better than the other. For example, a situation where a product is located at the correct identification number and the sensor identifies the product as being fully registered behind the pick-up head when measured against product specific information in the system database may be registered as an optimal state. When a product is picked up by the control system 100, the product is known because it is measured and its length recorded when it is serialized and put into inventory in the device. The control system 100 is also aware of the size, weight, shape, moment arm and other details related to the positioning of the product to be picked up.

The software driving the robot knows what the desired result is supposed to be and the robot concludes what state should occur for success. The robot also infers when it enters a state related to what the product is, and by combining the product information and sensor information, the robot infers how successful to do next. The control system 100 is controlled to do anything it can infer success.

The neural network is used by the system and each networked control system 100 to allow it to learn from previous actions and outcomes. The state transition may provide learning knowledge to the control system 100. For example, if the robot completes a particular state and reaches that state using a particular behavior, this is learned knowledge that is retained by the control system 100 for future use. A set of 25 different behaviors is applied by the robot. If the robot is in a similar state as it did before and the behavior it attempted before was not successful, it will not attempt the same behavior and will attempt another behavior. Control systems are controlled to apply behaviors based on risk levels, becoming increasingly proactive to success. In the state table, each state reaction is used to control this progress of the robot, so that for example it will try 1 for e.g. shift recovery, then try 2 for active shift recovery, and then try 3 for maximum shift recovery.

The control system 100 is also controlled to do anything within its capabilities to avoid failure so that it is not congested (because the device is unattended). The primary rule applied by the robot is that it must not be congested. For robots, no mistakes are a minor rule (low priority) because the robot has access to the waste container 115 and is used to guide the waste arm 110 that damages the product. If the control system 100 detects an error, it transfers the product to a waste container. The robot applies its hardware, followed by state machine behavior, to implement its first rules of non-congestion.

If the three attempts to pick up the product are unsuccessful, the robot reverts to the remote control mode by invoking the call centre screen of the human subject, alerting the human subject that an error has occurred and that manual reversion is required. The human subject may view the screen over a network and may summon a technician to start a remote control application over the network, manipulating the robot in real time so that the robot can service a user who is standing at the device 10.

When an error occurs, the control software of the control system 100 takes action to try to correct the error. The robot picks up the product from its storage location by bringing the pick head 50 to the storage location slot 207. The slot 207 has a gap in the front to allow the pick head 50 to insert the tab into the slot under the product. The pickup head 50 has a plurality of belts (or wheels or fingers) to pull product forward as the pickup head moves upward and onto the shelves of the storage container rack 205 as the product is lifted. This action picks up the first product on the storage rack location, separating it from the rest of the inventory that will (ideally) remain on the shelf. The pick-up head 50 then senses the size, shape, weight of the product it picks up to determine that it picked up a single unit of product and that it overcomes three common errors, namely, pick-up drag (the case where the package is still in place because of slippage), double pick (the case where two packages are close together, entangled, or stuck together), and multiple pick (typically due to labels stuck together). Using sensors and tables of information about the inventory product being dispensed, the state machine determines errors based on physical parameters of size and weight, and for products containing RFID (radio frequency identification) tags, makes them visible by scanning and detecting the presence of more than one RFID tag or more than one bar code (if one is present in such a configuration).

Based on the foregoing information, the control system 100 determines with high accuracy whether a product is present, whether there is an error, and the status of the error (if any). When an error occurs, using the error status information, the robot performs a series of escalating interventions to attempt to resolve the error. If there is no product in the pick head 50 and the robot knows that there is a product in the slot 20, the machine state is pick up blocked. In this state, the robot performs a primary pick-up impediment resolution action called "shake pick-up", where a software control loop causes the robot to vibrate up and down within a range of motion and speed determined to be appropriate for the primary solution range. In "shake pick up", distance is important to effectiveness, to minimize damage to robots, storage racks and products. Sensors on the pickup head determine the depth of entry into the shelf and maintain a safe distance from the surface to minimize the possibility of touch damage. The "rocking pick-up" causes the blocked product to separate from the shelf much like a vibrating conveyor moves the product against friction.

Two products may stick together resulting in two products being loaded into the pick-up head instead of one product. In storage bins, the average angle between the panels of each product carton is small and this can cause the two cartons to fit when pressed against each other or when the paperboard is wet.

This increases the chance that when the pick head lifts one cassette, it may actually lift two cassettes, thereby creating a double pick error. To solve this problem, a secondary remedial action is performed by the local control software, i.e. a higher displacement is generated on the control head, so as to change the angle at which the products are fixed, thereby reducing the contact area between the first and second products, generating a separation angle, and generating a contact point that does not allow the abutment, so as to pick up only one cartridge.

A third common pick-up problem is multi-pick, i.e. the case where several products are stuck together, which is often caused by labels or label glues sticking several packages together. The sensors and machine operation software are capable of determining multiple pick-up errors based on the weight of the load, the moment arm, the size of the load, and the load characteristics measured by the parameters of acceleration and deceleration delays. If the multiple pick error cannot be resolved by the aforementioned solution one or two, the local operating software is upgraded to solution three, thereby using the edge of the pick bin as a guillotine to remove excess product from the picked product. Since the removed product may be damaged or destroyed by the three-stage tampering removal action, any removed product is placed in the waste container 115 and is not dispensed until integrity is confirmed.

The drug dispensing device must be reliable in view of the availability of services, primarily. The ideal machine is never out of order, but integrating the different nature of the communications, software and hardware, and the variety of products and packaging that must be operated inevitably results in an error rate greater than zero.

However, errors are probable, and therefore error management, isolation, and recovery are paramount to prevent failures. The core reliability algorithm used by the apparatus 10 of the present invention is defined in terms of absolute parameters or criteria (edict). Each criterion overrides a dependent criterion, and criterion one overrides all other criteria. The criteria are as follows:

criterion one: patient safety-no activity can compromise patient safety.

Criterion two: protection of property-no activity can compromise the safety of drug inventory, the safety (sequence) of the machine.

Criterion three: and maintaining operability.

Criteria one is described in detail in the above-mentioned published PCT application (WO 2008/006203). Criteria two require a gradual upgrade procedure without opening the machine or drug vault. Criterion three requires an escalation procedure that is as straightforward as possible to maintain the service state and core utility of the device. The dispensing device 10 is networked to a computer system so that any errors that occur on the device with respect to product (SKU) become part of the shared network experience and common error log, contributing to the system knowledge base accumulation. Error parameters may be analyzed for developing trends, such as errors that are common to a particular machine or a particular machine configuration or a particular condition or a particular package or product variation. As a component of the neural network, each software-controlled robot has preprogrammed autonomous actions, and the state machines can be adapted to change to deliver the desired results under the control of a tightly applied rule set.

As described above, the state machine of the robot effectively learns to recognize conditions and acquire knowledge in the form of a recorded history of the results of various solutions, thereby adding to the collective operational knowledge base, allowing the robot of each networked dispensing device 10 to learn from successful results. For example, product congestion that traps pick-up heads is a common cause of out-of-service dispensing equipment. The robot has a set of programs separating it. Although the robot knows its slot location and knows the product SKU on the platform, the robot will find that its X and Y axis motion is blocked.

If the database has no precedent for a particular problem, the software begins the following resolution sequence, starting with minimal destructive behavior: shake slightly, yes/no resolution; escalate to strong jolt, yes/no resolution; escalate to pull the platform backwards while shaking vigorously, reverse pick-up tape while applying the X-axis upwards to force the products apart, sacrifice product for discard process (this action will discard one product SKU), yes/no resolution; escalation to forward the platform to hit the slot and raise the contents of the slot before dropping them into a waste container (this action will discard all remaining product SKUs in the slot, but if successful, enable the robot to pick and dispense from the remaining slot), yes/no resolution; reverting to shutdown, seeking help center technical intervention, opening a remote manipulation session whereby multiple cameras within the plant allow remote technicians to fix the central location to view the plant interior and remotely manipulate the robot to solve the problem (this action avoids on-site intervention and the plant is not opened so that the intervention does not raise a safety issue), yes/no solution; upgrade to local callouts, whereby qualified local technicians verified to enter security level one (the front of the machine) are dispatched to the site, the front of the machine is opened and the problem can be repaired if it is outside the drug vault, yes/no resolution; finally, upgrade to a portal service (truck roll), thereby calling up the high-level technician, and the high-level technician is authorized security level two (access to the drug storage room) and can resolve the problem by opening the back-end drug storage room module(s).

The foregoing hierarchical error resolution process by which dispensing device 30 determines when an error condition has occurred and is able to resolve the detected error serves to maximize service time of the device, maximize patient utility, provide a quick response to errors, provide a low cost-of-service structure, and optimize safety of machine and drug inventory.

The physical security of the dispensing device 10 is enhanced by the hierarchical access configuration of the device as shown in fig. 5A-5C. Access level one is illustrated by fig. 5A and 5B1-5B3 and provides access to the front of the device, which houses the user interface components, waste portions, pick head libraries, and conventional dispenser services, at locations 160, 170.

Access level two is shown in fig. 5C and provides access to the drug storage compartment module, which includes a controlled and isolated cold storage section (if any) and bulk storage containers. Two types of security are applied to these levels of access. The technician must have a valid ID to allow access to the device front-end.

The webcam confirms the identity of the technician, confirms that the technician's credentials are new and authorizes the technician to access the machine at that time, and confirms that a work order was generated at the dispensing device to track time and activity. In the event that a network connection cannot be established through the device due to a network outage or power failure extending beyond the support time of the internal UPS, a controlled access key may be used to access the primary internal space to restore power or network connectivity. Access to the secondary controlled area of the device (e.g., drug vault module) can only be accomplished with network confirmation.

To optimize user utility in connection with dispensing equipment and to service high traffic levels, the equipment must provide a high level of prescription coverage. One obstacle to doing so is that some drugs (e.g., insulin for diabetes, eye drops for glaucoma, and several pediatric drugs) require refrigerated storage and are ineffective if such drugs are stored outside their temperature range (e.g., if the range is out of two to eight degrees celsius). On the other hand, some medications (e.g., sugar) need to be stored at room temperature, which is limited to fifteen to twenty-nine degrees celsius.

Advantageously, the dispensing apparatus 10 of the present invention overcomes the above-described obstacles by providing a combination of an isolated refrigeration section 250 in the drug storage compartment module 200 that can store a drug at a controlled refrigeration temperature and a controlled room temperature section 240 in the drug storage compartment module 200 that stores a drug at room temperature, as shown in fig. 6. The device also contains monitoring sensors (not shown) within the storage area that sense internal temperatures for temperature control purposes and monitor temperatures to report to a log file for proper temperature storage verification of drug pedigree files and report any temperature fluctuations to the network in the form of high or low temperature alarms to obtain remedial action. Any drugs that have been exposed to temperatures or times and temperatures outside of its allowable range are marked for identification by the drug pedigree established by the system and removed from accessible inventory for disposal.

As with known medication dispensing apparatus, the apparatus 10 of the present invention is capable of dispensing only pre-packaged products, which are single unit articles known as "standard dose" articles or packages. A pre-packaged product means that the article is suitable for use in a dispensing machine and for dispensing to a user, but the actual number of pills, capsules etc. contained in a given standard dose package will vary based on the pharmaceutical product and the dose usage. This usage is derived from information provided by the pharmaceutical manufacturer and ordinary dosing practice for the drug. However, from a user's functional standpoint, the dispensing device is not functional if the prescription requires 10 pills and the device only holds 8 standard dose packages of pills. The device 10 solves this common problem by providing a bulk drug storage area 215 in its rear drug vault module 200 and a pill counter 270 integrated into the bulk storage container for the pill/capsule product 230.

One common problem encountered in autonomous pill counting is the reliable, safe and clean handling of medication administration without cross-contamination. The device 10 includes a large bulk pill/capsule storage container 230 that allows the medication to be safely stored and sealed in bulk and only accessed by a dedicated handling device until dropped into the dispenser package and dispensed to the user. This corresponds to a contactless technique SOP that eliminates the possibility of cross-infection. The storage container 230 has certain dimensions to allow it to be stored in a standard storage slot, and certain features to allow the robot to operate reliably. It also has specific security features to prevent tampering during transport.

The bulk pill/capsule storage container 230 is shown in fig. 24A-B and allows the robot to select and cause the pill/capsule pills to be delivered to a counting unit that includes a pill sorter 260 and a counter 270 integrated into the container 230, as shown in fig. 7. The tablets or capsules are stored in a hopper of the container 230.

In one embodiment of the pill dispenser, a vibratory screw feeder (not shown) lines up the medicament before it is delivered from the hopper to a counting unit that counts the number of pills or capsules guided by the robot. When the product count is reached, a petal mechanism (not shown) causes the pill flow to return to the bulk storage container 230.

Another embodiment of a pill dispenser is shown in fig. 24C-H. Each container of the array of bulk storage containers (one of which 402 is shown in these figures) contains a pill 404 of some type. The container 402 has a pill guide exit chute 404 and a vertically arranged, integrally formed cylindrical exit nozzle 406. An annular cylindrical restrictor 408 is mounted within the outlet nozzle. The restrictor 408 may be moved up and down within the nozzle 406 by a drive mechanism (not shown) to vary the width of an annular outlet region 410 extending between the restrictor 408 and a conical hub 412 of a disc 414. A ring gear 416 on the lower surface of the disc 414 has teeth that mesh with a pinion gear (not shown) whose drive from the pinion gear is used to drive the ring gear to rotate the disc 414. The disc is mounted such that its upper surface slopes downwardly toward the hub 412 to define a disc shape. The disc 414 is formed at least on its upper surface of a material having a high coefficient of friction and also has an integrally formed series of small arcuate tabs 418.

As shown in fig. 24C, a scraping guide 420 having an inner end near the hub 412 and a generally spiral shape extending almost to the outer edge of the disc is installed above the disc with its lower edge abutting against the upper surface of the disc. The separator 424 is mounted adjacent to the upper surface of the disk and in close proximity to the barrier wall 422 in which the disk rotates. The separator is a generally radially extending plate that defines a triangular opening with the barrier wall 422 and the upper surface of the disc. A separator 424 is downstream of the end of the helical scraping guide 420 in the direction of disk rotation and a radially reciprocating gate 426 is downstream of the separator. Only the scraping guide, the separator, and the door are shown in fig. 24C.

In operation, the prescription is read and interpreted as previously described and instructions are sent to the pill dispensing control module to instruct that a prescribed number of such pills are to be dispensed from an inventory of pills of the type contained in a selected one of the bulk storage containers 402. The result of the instruction is to provide a drive to the selected pill dispenser to cause its drive gear to begin rotating the disk 414. Further drive is applied to move restrictor 408 to a predetermined position where annular exit region 410 is sized to allow pills 404 to fall under gravity through exit region 410 onto the disc upper surface in a metered velocity sequence. The position of the restrictor is set such that the speed of the pills through the exit area is not so great as to overload the subsequent pill counting and pill packing stages of the apparatus, nor so small as to cause a congestion of the pills in exit area 410. Once the pills fall on the upper surface of the disc, the disc surface, the fins 418 and the scraping guide 420 interact to drive the pills in a helical path toward the barrier wall. Pills driven toward the outer edge of the disc tend to become dispersed and driven in an arcuate path against the wall barrier 422. Ideally, the pills are lined up and sequentially pass through openings in separator 424. However, if multiple pills stick together due to stiction or other surface conditions, the separator 424 allows only one sticking pill to pass through at a time, any sticking pills being stripped off and then provided to the separator by the rotating disk.

Under solenoid actuation (not shown) from the control module, the door 426 remains in the open pill passing position as long as the full count of pills to be dispensed has not been reached. After the pills are discharged by the disc drive through the gate, they fall through the counting area 428 into the previously positioned empty pill bottle. In the counting zone, the pill falls through an array of photodiodes and associated photodetectors (not shown). The photodetector is arranged to record a pill count as each pill falls into the pill bottle. Software controls the door to close when the number of pills counted equals the prescribed number of pills.

Prior to dispensing pills through the counting area, an empty pill bottle is brought to the selected pill dispenser and temporarily placed in a position where pills dispensed from the bulk storage container fall into the bottle. The pill bottles are retrieved and moved by the control system, which may be actuated in the X and Y axes to move across the full vertical area of the drug storage compartment, as previously described with respect to the pick-up and delivery of pre-packaged drug products. The control system may also be moved to the vial area where an array of empty vials of various shapes and sizes are stored along with an array of matching caps. The control system comprises a pick-up head as previously described with respect to picking up pre-packaged pharmaceutical products, the pick-up head having fingers and a hook, the fingers being reciprocally movable along a Z-axis. In operation, in the bottle area, the fingers are driven in the Z-axis direction to a position below the slot in the bottom of the container into which the bottle falls after the previous software controlled selection and release from the bottle storage strip. As in the case of pre-packaged drug product handling, the fingers move upward in the slots to support the empty vials. When the finger is retracted along the Z-axis, the hook engages the bottle to retract it from the container.

The control system is also provided with a platform. A hinge mechanism forming part of the control system grips the empty bottle and moves it onto the platform and into an upright position where it is locked relative to the platform. The control system then operates to transport the platform to a position where the upright bottle is positioned to receive pills falling from the selected pill dispenser.

The control system also includes a cap pick and place module. After the desired number of pills are dispensed into the bottle as previously described, the cap pick and place module places the selected cap on the open neck of the bottle and the lever mechanism presses the cap downward to snap it onto the neck. The control system is then actuated to deliver the vials containing the dispensed pills to a delivery area accessible to a user of the vending machine.

It should be understood that fig. 24A-H depict only two forms of pill separators and counters for dispensing pre-packaged and bulk pills in a networked arrangement. The present invention contemplates other forms of dispensing pills, lozenges and capsules and also contemplates dispensing and packaging bulk liquid medicaments in an arrangement similar to a pill dispensing arrangement except for design changes to accommodate liquid handling.

In pill dispensing and liquid dispensing arrangements, care is taken to avoid contamination of the medicament being dispensed. Thus, the mechanical control elements are encapsulated and closed, if possible, to avoid the ingress of dust and steam. In addition, dust, liquid and vapour seals and barriers are installed at the positions where the elements of the dispensing mechanism move relative to each other, if possible.

The prescribed medication is then transferred to the medication packaging module 280 (see fig. 8A-B) via a vibrating screw-feed delivery mechanism (not shown). Alternatively, the device may be configured for placing the medication packaging module at the outlet of the counting unit. The bulk pill/capsule storage container 230 is sealed and secured.

Alternatively, the device 10 may be configured such that the bulk pill/capsule storage container 230 can only dispense medication when inserted into the dispenser module under the control of the robot. This configuration allows for strict batch and inventory control and maintenance of drug pedigrees. The prescription count medications are loaded into the hopper 290 of the packaging module 280 and packaged by the bottle wrappers 300 or foil wrappers 310 of the packaging module 280. Optionally, the drug count may optionally be verified during the transfer between the counting unit and the packaging module. The hopper 290, vibratory conveyor and counting unit (and optionally transfer port) are optionally checked to confirm that no medicament remains in those locations (i.e., no medicament remains) before the bulk medicament container 230 is emptied for the next use. The medication packaging module 280 is configured for packaging medications in two ways. First, it can be bottled with the drug, inserted into sterile bulk material and applied with a cap. The cap rotator (not shown) applies a known torque, tests the opening torque to verify cap function, and reapplies the torque to restore to the original torque setting. Drug pedigree certificates generated by the system add "cap intact" notes to the pedigree. Second, the medication packaging module 280 may package the medication into sterile foil sealed bags, apply a foil seal and verify the seal by visual inspection. Obstacles are also encountered with liquid drug standard dose packages, especially pediatric drugs and maintenance drugs, where the dose varies by as much as 26. To address this obstacle, the dispensing apparatus 10 of the present invention provides a bulk storage container with an integrated pour unit 226 for the liquid product 220, as shown in fig. 25A-B. The bulk liquid drug container 220 is robotically operated to pour measured amounts of drug into a liquid dispensing container (not shown). Some drugs need to be reconstituted, usually with another liquid, before dispensing. The reconstituted bulk storage container 370 is shown in fig. 26A-C and includes a mixer/agitator 32 and a liquid/concentrate storage portion 34 for adding liquids to concentrate and delivering them to a mixing chamber for agitation or stirring. Similarly, some medications require two or more components to be mixed prior to dispensing. The mixing bulk storage container 380 is shown in figures 27A-B. The mixing container 380 includes a liquid storage portion 382, a mixer 384, and a mixing valve and conduit 386 for metering and dispensing a mixed medication to a liquid dispensing container based on any quantity or amount of liquid component by weight, volume, or percentage. Further, some drugs require geometric reduction of one or more components in the carrier. A dispensing bulk storage container 390 is shown in fig. 28A-B and includes a liquid storage portion 391, a mixer 394 and mixing valves and piping 396 for performing geometric reduction of one or more components in the carrier.

As previously described, each package must be marked. It would be valuable to have a marking apparatus and method that is versatile in the sense of being adaptable to such a range of package shapes and sizes. For pharmaceutical dispensing vending machines, the pharmaceutical packaging labels typically have a standard shape and size to allow them to pass through the printer, and must contain critical patient and pharmaceutical information that conforms to industry standards and provides a small range of variation in shape, size or material. Such labels are typically applied by moving a pressure sensitive adhesive backcoating label on a release carrier through a label printer and transferring the printed label to a medication container (e.g., a bottle or cassette). Known label transfer methods use a sponge, vacuum, or a combination of sponge and vacuum, a transfer medium, a transfer roll, and a pressure pad. Standard flat labels are required to be reliably and accurately placed and applied to the dispensed pharmaceutical products.

The package marking module of the apparatus is shown in fig. 10A-H. Referring in detail to fig. 10A and 10B, a package marking unit 510 is shown with upper and lower marking modules 512 therein. In normal mode, one of the modules is in use and the other module is a redundant suspend abort or other interrupt in the operation of the one module. The components of marking module 512 are mounted on mounting plate 514. As shown in fig. 10A, the rotatable element of the marking module is secured to a pulley 516 that is mounted on the opposite side of the mounting plate and is driven by a belt (not shown) from a motor 518. As shown in fig. 10C, the marking unit 512 is mounted within a support frame 520 of the medication dispensing vending machine. A pickup head 522 of the type described in pending U.S. patent application 12/503,989, which is specifically incorporated herein by reference, is also mounted in the frame.

As shown in more detail in FIG. 10D, each marking module 512 has a printer 524, a supply 526 of labels wound on a take-up reel 528, a take-up reel 530 associated with a tensioning device 532, and a motor 518. Label stock 526 takes the form of a release liner or liner 534 to which labels 536 are self-adhered along their length.

The marking module is used to apply labels to the pharmaceutical product containers or packages 538 that are transferred to the marking module 512 using the pick-up head 522. In use, a supply 526 of labels is pulled off a take-up reel 528 by a drive wheel 540 in the printer 524. Within the printer, the label stock is aborted and the intended medication identification data is printed onto the presented labels before the printer wheel 540 further advances the label stock 526 in preparation for applying the printed labels 536 to the containers 538. As the supply of labels 526 exits the printer 524, the printed labels 536 continue to adhere to the substrate 534 and the take-up reel 530 and tensioning device 534 pull the substrate around the small diameter roller 544 to thereby wind up the substrate 534 at a speed related to the throughput of the printer 524.

The label 536 is made of paper or plastic that is stiffer than the substrate 534 to which it is adhered on the take-up reel 528. The label 536 is separated from the substrate 534 due to the movement of the label 536 around the small diameter roller 544. The tag 536 is also sufficiently rigid so that it assumes a suspended position as shown in fig. 10D as it is progressively separated from the substrate 534. For this reason, the material of the tag 536 is sufficiently rigid to effectively prevent the tag from sagging under its own weight side-by-side along its longest edge. Label stock 526 is advanced to a point where about 7/8 of the length of the label is free of substrate 534 so that the label is suspended in preparation for a subsequent stage in the labeling process. It should be appreciated that while in the preferred embodiment the label 536 has a uniform stiffness across its area, in an alternative embodiment the label may be locally hardened, for example by one or more thicker regions, thereby achieving the stiffness required for separation from the substrate and temporary suspension of the label.

The pick head 522 is then actuated to pick up the medicament container 538 to be dispensed by the apparatus and raise the container to a desired height where a platform 548 forming part of the pick head and supporting the container is moved in a horizontal direction to bring the container to the position shown in figure 10D. At this point, the container is positioned under the hang tag 536 and the combination of the sensor and feedback ensures that the leading edge 550 of the tag is aligned with the preselected point of contact 552 on the product package.

In a subsequent stage of the marking process, the pick-up head 522 drives the package upwardly against a suitably cylindrical tamp block 554 of polyurethane foam, this movement serving to initiate "sticking" of the self-adhesive label 536 to the package 538 and removal of the final portion of the hang tag 536 from the substrate 534. The drug container 538 with the label attached is further raised by the pick head 522 to bring the label-facing-up container into contact with a second tamper block 556 formed of a suitable polyurethane foam, which is shown in fig. 10D and 10F-10H. The tamper block 556 is generally U-shaped and has a rigid restraining bar 558 mounted to the mounting plate 514 and extending and fixed between the two straight arms of the U-shape.

In use, a packaging container 538 with a label 536 adhered to at least a central portion of the container surface is brought against the cross member 560 of the U-shaped tamper block as shown in the sequence of operations of fig. 10F-10H. The straight arms of the U are anchored by restraining rods 558 and the U-shaped cross member 560 is relatively thin and flexible. Thus, as the product container 538 is moved in the direction of arrow a, the relatively thin and flexible U-shaped cross member initially conforms to the upper surface 562 of the packaging container 538, as shown in fig. 10G, such that a portion of the label is sandwiched between the cross member 560 and the front of the package. Then, in response to further upward movement of platform 548 in the direction of arrow a, as shown in fig. 10H, tamping blocks 556 are squeezed, causing U-shaped straight arms 564 to be pushed along receptacle sides 566. Since the straight arms 564 of the U-shape are prevented from further translational movement, they bend and fold as shown in fig. 10H and in such a case deform to enclose at least a portion of the respective side of the packaging container, thereby folding the label edge into adhering contact with both sides 66 and corners 568.

The dimensions and materials are selected so that pressure is directed to bring the label into contact with all desired portions of the package and sufficient pressure is applied to activate the contact sensitive adhesive. Since the size and shape of the package is known to the pick-up head control, accurate label placement can be achieved with high reliability and repeatability using this method.

It should be understood that first and second tamper blocks 54 and 56 may be combined as desired, whereby a first portion of the movement of container 38 relative to the combined tamper blocks is to adhere label 36 to the package, and then a subsequent portion of the movement is to effect the previously described rolling and application of the label. It should also be understood that alternative options for the U-shaped tamping blocks are also possible. The O-shaped and H-shaped blocks may thus, for example, be configured to provide relative translational movement and block deformation to apply labels to the front and sides of the package.

In addition, although the tamper blocks are suitably formed from a single cut or molded piece of material, the parts of the tamper blocks for front and side tamping, respectively, may be separate but mechanically hingedly coupled. It should be understood that in a preferred embodiment, the movement of the product container relative to the tamper block to apply the adhesive label to the front and sides of the package is a single unidirectional movement of the container. However, the movement may alternatively be effected as an intermittent action. For example, the first translational movement of the tamper block to apply the label to the front face of the package may be followed by a second movement in which a combination of translational and twisting motion is used to apply portions of the label against the side walls.

In addition, it should be recognized that the motion need not be unidirectional in nature. In further alternative embodiments, the product container is held in a fixed position for label application while the tamper block is moved, or both the tamper block and container are moved to effect label application. It should further be appreciated that while the deforming nature of the tamper block to effect pressure against the sides of the container occurs by squeezing the tamper block between a clamping fixture located on one side of the tamper block and the medication package on the other side of the tamper block, other external fixtures may be positioned to limit the locations to which portions of the tamper block may be deformed to the desired locations for effective application of the label to the container and those locations required for effective application of pressure at the contact locations.

The apparatus 10 may also include a further improvement for product marking in the form of an optical line striper 330 which directly prints the product package (container) to be dispensed. Fig. 11 shows a laser marking module 330 that directly marks (identifies) product containers 335 positioned on the robotic pick head 50. By adding a photosensitive coating on container 335, laser marking module 330 writes readable information directly onto container 335 without the need for transfer labels and the associated complexities of label transfer, placement and affixing. Loading the dispensing apparatus with medication is a time consuming, tedious, tiring, highly repetitive task and therefore subject to error. Eliminating these artifacts from the loading problem is important to reduce errors in the drug supply chain. Known loading methods rely on RFID tags to verify the drug, requiring the operator to flash each product over an RFID sensor that verifies the drug and identifies (e.g., by light) the appropriate storage slot to guide the operator to the correct placement location. The apparatus using such a known method displays a picture of the medicine with date, DIN, lot number, etc. on an internal screen, and then speaks the name of the medicine using a text voice generator. The reasons for the elimination of those prior art methods and devices are the time required to verify each product, and the additional cost of the device with an indicator light system with associated software and hardware to drive the lights, in addition to the cost of the RFID tags in each product. The dispensing apparatus 10 of the present invention uses RFID tags (if any), or optical product codes already on the prepackaged product, and is read by the robot and used by the robot to automatically place the product into inventory in the apparatus without the need for an operator to open the machine. The robot and networked computer system then know with complete certainty the location of all products in the machine and the status of the inventory without the possibility of human placement errors. Product loading occurs in two modes. First, after the operator passes the safety test setting the apparatus in manual loading mode, the apparatus provides a means for manual loading of the product by the operator. The product is placed in a manual loading slot 350 for robotic self-loading as shown in fig. 12. When a product is manually placed in the loading slot 350, it is accepted, read and placed by the robot into inventory within the apparatus. The cycle is repeated until inventory storage of the product load is completed. Second, the apparatus provides a means for automatically loading the product, as shown in FIGS. 13A-B. The secure transfer container 360 is used for secure transport of drugs and automatic loading into the device. In the auto-load mode, the operator places the secure transfer container 360 into the apparatus in the receiving port and the control system 100 automatically loads the product into inventory without requiring other tasks. When fully loaded, the empty secure transfer receptacle 360 is used to receive waste that is returned from the facility to the distribution center, so the transfer receptacle 360 also serves as the waste receptacle 115 in this mode. The secure transfer container is shown in fig. 14A-D and is provided with several types based on its contents, including refrigerated, non-refrigerated, pre-packaged product, bulk liquid, and bulk pill types. A universal secure transfer container 360 is also provided. A refrigerated secure transfer container 365 is shown in fig. 22A-B. The container is isolated and connected 368 by an external power source to provide active refrigeration during transport or storage on the road, and it contains a peltier effect type solid state cooling device 336 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 device or at the dispensing center and provides a secure transfer reservoir for the drug as it is transported between the device and the dispensing center, whereby the common carrier can be used to transport the product. As mentioned above, a measure of the utility of a device is that a drug requested by a user must be available from the device from which the drug is requested. Rear drug storage compartment module 200 of apparatus 10 has a fixed number of product storage slots 207. As shown in FIGS. 15A-d, each storage slot 207 can store up to five units of the same product SKU. In locations such as busy primary care clinics or hospital emergency rooms, this may make the storage insufficient to meet the demand for drugs that are in high demand in inventory for a reasonable restocking turnaround time, making it possible for the high demand drugs to be exhausted before the next restocking, especially during a recurrent season or event. In such a scenario, multiple modules of the device may be co-located to replicate or multiply the number of user interfaces present, allowing more than one patient to be served at a time. Further, apparatus 10 is configured to allow inventory products of one drug vault module 200 to be picked up by control system 100 and securely transferred to another co-located drug vault module 200. The patient may be served by the first device 10, where some portion of the required medication may not be in stock in the device, but is available and in stock at the second device 10. The first device 10 queries the second device 10 for availability and requests a secure transfer of medication if the product is available. The robot of the second apparatus is instructed to perform product pick-up, scan and verify that the product is correct and then deliver the product to the left or right side of the apparatus a secure transfer slot (not shown). The robot of the first device moves to the right or left secure transfer slot of the device and when in the correct position, the transfer instruction handshake between the first and second devices is exchanged, allowing the transfer port to open and transfer the requested product from the platform of the robot of the second device to the receiving platform of the robot of the first device. After the transfer is complete, the second device retracts its robotic platform, verifies that the transfer is complete and closes its transfer door. The robot of the first device verifies the received product, confirms the identity of the product against the drug record, and continues the dispensing cycle in the same manner as if the drug were located in the drug storage compartment module of the first device. Multiple devices 20 may be co-located, for example, in a three device co-location facility, and a first device may request a medication from a third device, thereby instructing a second device to act as a medium and deliver the medication through the device. Further, from the viewpoint of the utility of the user, there is no matter such as no medicine. If the medication has been prescribed, it is immediately desirable and required to begin treatment. Users rarely sell the special medications they need and are therefore rarely in stock. For patients, the utility value of the dispensing device is that it can dispense the required medication when requested. For example, there are many medications that are necessary for tropical diseases, but are rarely dispensed. The apparatus 10 of the present invention employs a method that allows hardware and software to designate a particular storage slot 207 as a library of multiple product SKUs. Slot 207 is oriented vertically and operates according to first-in-first-out inventory control rules. This is accomplished by picking up the product from the bottom of the slot and placing the new product on top of the slot. In a library-style designated slot containing five different individual product SKUs, the intended product may be a third product in the slot. The robot moves to the slot position and picks up item one from the bottom. The robot returns the item-one to the top of the same slot for restocking. The robot returns to pick item two and returns it again for restocking. The robot then picks up item three (the intended item), checks it and continues the dispenser preparation cycle. The product inventory location register of the system is modified to indicate that the previous product one is now at location three, the previous product two is now at location four, the previous product three is now at location one and the previous product four is now at location two, and the slot table accepts an additional product SKU on the restock. The refrigerated storage module 250 of the appliance 10 is shown by figures 19A-B, 20 and 21. It has an isolated perimeter and an isolated sliding door 252 that can be opened in a low headroom environment by means of a sliding mechanism or track such that the sliding door is open to expose its internal contents to the robot and out of the way in a plane perpendicular to the X-Y axis of motion of the robotic pick-up head 50. Its track has a shape or the door has a mechanism whereby the door is sealed at the periphery when closed and collapses or moves away from the seal or seals to provide clearance for door operation. The door is operated by a linear actuator, a pulley, a cable, a toothed belt system or by a latch which can be engaged by the robot head to open and close the door. The refrigerated storage module 250 is also in communication with (or may contain) an external vacuum pump 258 capable of providing a reduced atmospheric pressure within the refrigerated storage chamber immediately after the door is closed, thereby providing door sealing and removing ambient air and moisture that is introduced into the refrigerated storage module when open. The refrigerated storage module 250 contains a peltier effect type solid state cooling device coupled to an array of heat absorbing aluminum heat sinks to remove heat from within the refrigerated module without the need for a compressor, a condenser and an evaporator.

It will be appreciated that in dispensing both pre-packaged products in stock and bulk pharmaceuticals in stock in such a manner as to have a high first prescription rate, a major problem is the respective requirements for vending machines having a high volume/footprint to accommodate a wide variety of pharmaceuticals, a wide variety of dispensing methods and a wide variety of quantity dispensing capabilities. It should be appreciated that the networking arrangement according to one aspect of the present invention allows for some of these activities to be conducted at a location remote from the vending machine, allowing for some reduction in the volume/footprint of the vending machine. In addition, in a control system for a pharmaceutical product containing a dispensed bulk medicament (pill-type medicament or liquid medicament) and for dispensing a pre-packaged product, vending machine volume and footprint are reduced by having certain elements of the control system be used in common in multiple stages of the dispensing process. This means that multiple drugs are dispensed by multiple dispensing methods to achieve multiple dispensed amounts does not necessarily require multiple customized control subsystems.

Claims (15)

1. A device for delivering a medicament to a user, the device comprising: a medicine storage compartment having a pre-packaged product storage container for containing a pre-packaged pharmaceutical product; a bulk product storage container for containing a medicament in bulk form; and a control system operable to effect at least a portion of the process of dispensing bulk form medication from the bulk product storage container, packaging the dispensed bulk form medication as a dispensed packaged medication product, and picking up and delivering the medication product to the delivery area.

2. The device of claim 1, wherein at least a portion of the control system is collectively configured to manipulate both a pre-packaged pharmaceutical product and a dispensed packaged pharmaceutical product.

3. The apparatus of claim 1, wherein the control system comprises a medication packaging module operable to dispense a bulk form of medication and package the bulk form of medication as a dispensed packaged medication product, the dispensed packaged medication product being one of a bottle, a box, and a foil package.

4. The apparatus of claim 1, further comprising a metering module operable to meter a selected amount of the bulk form medicament and deliver the selected amount from the bulk product storage container.

5. The apparatus of 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. The apparatus of claim 5, wherein the metering module further comprises a sorter that successively takes items of the individually dispensable items and conveys the taken items for packaging, and a counter that counts the number of items taken from the individually dispensable items in bulk form and conveyed for packaging.

7. The apparatus of claim 6, wherein the individually dispensable items are one or more of pills, lozenges and capsules.

8. The apparatus of claim 1, wherein the bulk form medicament is stored as a liquid in a bulk product storage container.

9. The apparatus of claim 8, further comprising a metering module operable to meter the bulk form of the medicament as a metered volume of liquid.

10. The apparatus of claim 8, wherein the bulk storage container is located within a refrigerated area, whereby the liquid medicament stored in the bulk storage container is maintained at a low temperature to prevent heat-induced deterioration of the liquid medicament

11. The apparatus of claim 1, further comprising a processing mechanism operable to change the bulk form medication from an inventory state to a dispensing state before the bulk form medication is dispensed and packaged as a dispensed packaged medication product.

12. The apparatus of claim 11, wherein the processing mechanism is operable to effect at least one of mixing, agitation, and dilution of the bulk form pharmaceutical product.

13. The apparatus of claim 1, further comprising: a user interface module configured to receive prescription information input from a user; a control module that interprets the prescription information and issues commands to the control system based on the received prescription information, thereby causing the control system to select between picking up the prepackaged pharmaceutical product and delivering the prepackaged pharmaceutical product to the delivery area and picking up the dispensed pharmaceutical product and delivering the dispensed pharmaceutical product to the delivery area.

14. The device of claim 13, further comprising a network interface for connecting the device into a network, the network interface operable to transmit a status of device information onto the network and operable to receive command information from the network for control of the control system.

15. The apparatus of claim 13, wherein the drug repository is configured for secure storage of drugs and is connected to the user interface module, the user interface module forming a front end of the apparatus and the drug repository forming a back end of the apparatus.