Patent Publication Number: US-11661277-B2

Title: Automated pharmacy dispensing machine with autocalibration station

Description:
RELATED APPLICATION 
     The present application claims priority from and the benefit of U.S. Provisional Patent Application No. 62/866,323, filed Jun. 25, 2019, the disclosure of which is hereby incorporated herein in its entirety. 
    
    
     FIELD OF THE INVENTION 
     The present invention is directed generally to the dispensing of prescriptions of pharmaceuticals, and more specifically is directed to the automated dispensing of pharmaceuticals. 
     BACKGROUND OF THE INVENTION 
     Pharmacy generally began with the compounding of medicines which entailed the actual mixing and preparing of medications. Heretofore, pharmacy has been, to a great extent, a profession of dispensing, that is, the pouring, counting, and labeling of a prescription, and subsequently transferring the dispensed medication to the patient. Because of the repetitiveness of many of the pharmacist&#39;s tasks, automation of these tasks has been desirable. 
     Some attempts have been made to automate the pharmacy environment. Different exemplary approaches are shown in U.S. Pat. No. 5,337,919 to Spaulding et al. and U.S. Pat. Nos. 6,006,946; 6,036,812 and 6,176,392 to Williams et al. The Williams system conveys a bin with tablets to a counter and a vial to the counter. The counter dispenses tablets to the vial. Once the tablets have been dispensed, the system returns the bin to its original location and conveys the vial to an output device. Tablets may be counted and dispensed with any number of counting devices. Drawbacks to these systems typically include the relatively low speed at which prescriptions are filled and the absence in these systems of securing a closure (i.e., a lid) on the container after it is filled. 
     One additional automated system for dispensing pharmaceuticals is described in some detail in U.S. Pat. No. 6,971,541 to Williams et al. This system has the capacity to select an appropriate vial, label the vial, fill the vial with a desired quantity of a selected pharmaceutical tablet, apply a cap to the filled vial, and convey the labeled, filled, capped vial to an offloading station for retrieval. Other aspects of this and similar systems are discussed in U.S. Pat. Nos. 7,555,362; 7,565,782; 7,770,358; 7,832,591; 7,837,061; 7,840,307; 7,870,973; 7,949,427; 7,980,419; 7,988,017; 7,992,365; 8,016,095; 8,056,760; 8,061,560; 8,261,936; 8,464,901; 8,499,967; 8,869,861; 8,714,405; 8,972,047; and 9,299,213, the disclosures of which are hereby incorporated herein by reference in full. The system employs bins or cells that each contain a single pharmaceutical (as used herein, the terms “pharmaceuticals,” “pills,”, “tablets,” and the like are used interchangeably and are intended to encompass any discrete sold or semi-solid form of a medicament). Vial filling and counting is performed via the introduction of an air stream into the cell to agitate the pills stored therein; the agitated pills are then conveyed via the air stream through an inlet and into an exit channel. The exit channel leads to an outlet, from which the pills are dispensed into the vial. While in the channel, the pills, which are singulated into a single-file stream, are automatically counted. 
     Although this particular system can provide automated pharmaceutical dispensing, certain of the operations may be improved. As an example, the aforementioned system includes identical cells that are customized for the pills they will be dispensing. This may include adjustment of the dimensions of the channel inlet and any baffles present in the cell. Such calibration can be time-consuming and can introduce potential error into the system. Also, often users change the pharmaceutical within the cell (e.g., demand may change with the season, weather, population shift, new manufacturer, etc.). For these reasons and others, it may be desirable to provide a technique for automatically calibrating the cells. 
     SUMMARY 
     As a first aspect, embodiments of the invention are directed to an automated pharmaceutical dispensing system, comprising: a tablet dispensing station comprising a plurality of cells for dispensing pills, each of the cells mounted in a dispensing location, each of the cells including a channel for dispensing pills into a container and an inlet configured to be adjustable so that pills in the cell are conveyed through the inlet and into the channel in single file; and an autocalibration station, the autocalibration station comprising a mechanism for automatically adjusting the inlet of a cell based on the dimensions of the pills to be contained in the cell. The autocalibration station is configured and located to also provide a dispensing location, such that a cell docked therein may function to dispense pills. 
     As a second aspect, embodiments of the invention are directed a method of loading a cell into an automated pharmaceutical dispensing system comprising the steps of:
         (a) providing an automated pharmaceutical dispensing machine, comprising:       

     a tablet dispensing station comprising a plurality of cells for dispensing pills, each of the cells mounted in a dispensing location, each of the cells including a channel for dispensing pills into a container and an inlet configured to be adjustable so that pills in the cell are conveyed through the inlet and into the channel in single file; and 
     an autocalibration station, the autocalibration station comprising a mechanism for automatically adjusting the inlet of a cell based on the dimensions of the pills to be contained in the cell;
         (b) docking a cell to be calibrated in the autocalibration station;   (c) identifying a pill type to fill the cell in the docking station;   (d) automatically adjusting the inlet of the cell with the autocalibration station based in the pill type identified in step (c); and   (e) loading the cell with pills identified in step (c); and   (f) dispensing pills from the cell in the autocalibration station.       

     As a third aspect, embodiments of the invention are directed to an automated pharmaceutical dispensing system, comprising: a tablet dispensing station comprising a plurality of cells for dispensing pills, each of the cells mounted in a dispensing location, each of the cells including a channel for dispensing pills into a container and an inlet configured to be adjustable so that pills in the cell are conveyed through the inlet and into the channel in single file; and an autocalibration station, the autocalibration station comprising a mechanism for automatically adjusting the inlet of a cell based on the dimensions of the pills to be contained in the cell. The autocalibration station is configured and located to utilize at least one cell mounted therein as a dispensing location. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         FIG.  1    is a flow chart illustrating operations of an automated pharmaceutical dispensing system. 
         FIG.  2    is a front perspective view of an automated pharmaceutical dispensing system according to embodiments of the invention. 
         FIG.  3    is a rear perspective view of an automated pharmaceutical dispensing system of  FIG.  2   . 
         FIG.  4    is a perspective view of a cell of the automated pharmaceutical dispensing system of  FIG.  3   . 
         FIG.  5    is a side section view of the cell of  FIG.  4   . 
         FIG.  6    is a rear section view of the cell of  FIG.  4   . 
         FIG.  7    is a flow chart illustrating operations for autocalibrating a cell with the autocalibration station of the automated pharmaceutical dispensing system of  FIG.  2   . 
         FIG.  8    is a top perspective view of the autocalibration station of the automated pharmaceutical dispensing system of  FIG.  1   . 
         FIG.  9    is an opposite, bottom perspective view of the autocalibration station of  FIG.  8   . 
         FIG.  10    is a top perspective view of the autocalibration station of  FIG.  8    with two cells positioned therein. 
         FIG.  11    is an opposite, bottom view of the autocalibration station and cells of  FIG.  10   . 
         FIG.  12    is a side view of a calibration locking mechanism for a calibration according to alternative embodiments of the invention, shown without a cell in place. 
         FIG.  13    is a front perspective view of the calibration locking mechanism of  FIG.  12    with a cell locked in place. 
     
    
    
     DETAILED DESCRIPTION 
     The present invention now is described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. 
     In the figures, certain layers, components or features may be exaggerated for clarity, and broken lines illustrate optional features or operations unless specified otherwise. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. 
     It will be understood that, although the terms first, second, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer or section from another region, layer or section. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the present invention. The sequence of operations (or steps) is not limited to the order presented in the claims or figures unless specifically indicated otherwise. 
     Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the specification and relevant art and should not be interpreted in an idealized or overly formal sense unless expressly so defined herein. Well-known functions or constructions may not be described in detail for brevity and/or clarity. 
     The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising”, when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items. 
     As used herein, phrases such as “between X and Y” and “between about X and Y” should be interpreted to include X and Y. As used herein, phrases such as “between about X and Y” mean “between about X and about Y.” As used herein, phrases such as “from about X to Y” mean “from about X to about Y.” 
     An exemplary process is described generally with reference to  FIG.  1   . The process begins with the identification of the proper container, tablets or capsules and closure to be dispensed based on a patient&#39;s prescription information (Box  20 ). A container of the proper size is dispensed at a container dispensing station (Box  22 ), then grasped and moved to a labeling station (Box  24 ). The labeling station applies a label to the container (Box  26 ), after which the container is transferred to a tablet dispensing station (Box  28 ), from which the designated tablets are dispensed in the designated amount into the container (Box  30 ). The filled container is then moved to a closure dispensing station (Box  32 ), where a closure (e.g., a cap) of the proper size has been dispensed (Box  34 ). The filled container is secured with a closure (Box  36 ), then transported to an offload station and offloaded (Box  38 ). 
     A system that can carry out this process is illustrated in  FIGS.  2  and  3    and designated broadly therein at  40 . The system  40  generally includes as operative stations a controller (represented herein by a graphics user interface monitor  42 ), a container dispensing station (not shown), a labeling station (not shown), a tablet dispensing station  62  with cells  63 , a closure station (not shown), and an offloading station  66 . In the illustrated embodiment, containers, tablets and closures are moved between these stations with a single robotic carrier (not shown); however, in some embodiments only a single carrier may be employed, or one or more additional carriers may be employed. The system  40  may include a database containing information about pill identity, NDC information, pill dimensions, cell adjustment settings, etc. The operation of the container dispensing station, the labeling station, the tablet dispensing station  62 , the closure station, and the offload station  66  are described in, for example, the patents referenced and incorporated hereinabove. 
     As can be seen in  FIG.  3   , the system  40  also includes an autocalibration station  100  that is located on the side of the system  40  where the cells  63  of the tablet dispensing station  62  are located. The autocalibration station  100  provides the system  40  with the ability to automatically calibrate cells  63  when either a cell  63  is initially placed in service or when the contents of the cell  63  are changed (e.g., the pills contained therein are switched out for another set of pills, which may include a different drug entirely, the same drug from a different manufacturer, or a different dosage or form of the same drug). 
     Referring now to  FIGS.  4 - 6   , a typical cell  63  is shown therein. As described above, each cell  63  dispenses a specified number of pills via the introduction of air into the cell  63 , which agitates the pills, then conveys the pill  63  through a channel  65  and out of an outlet  67  into a vial positioned beneath the outlet  67 . As the pills are conveyed through the channel  65 , they are counted, with a stream of pills continuing to flow until the desired number of pills is reached. Importantly, the pills are conveyed in “single file” for accurate counting. Singulation of the pills into the “single file” stream is regulated by an adjustment mechanism at the inlet  69  of the channel  65 , which includes walls that can be moved into a position in which the pills may enter the channel inlet  69  only one pill at a time and in a preferred orientation. Adjustment of these walls is controlled by two adjustment knobs  76 ,  78  that are located, respectively, on the side wall and floor of the cell  63 . The structure and operation of the singulating mechanism is discussed in detail in, for example, U.S. Pat. No. 7,988,017, supra. In addition, the cell  63  includes a baffle adjustment mechanism  71  that enables baffles within the cell  63  to be adjusted for different pill types. 
     When a user wishes to either initially fill a cell  63  with pills or to replace the contents of a cell  63  with a different pill type (i.e., either a different drug or the same drug in a different form, dosage, etc.), the cell  63  needs to be calibrated or set up for the pills it will contain. Typical steps that comprise calibration are set forth in  FIG.  7   . As can be seen therein, the calibration process may include the following steps:
         Scanning a stock bottle for NDC and scanning cell serial number (Box  202 );   Querying whether the drug is appropriate for autocalibration (Query  204 );   If Query  204  is negative, manually calibrating the cell (Box  206 );   If Query  204  is positive, docking the cell in the autocalibration station (Box  208 );   Adjusting the height of the channel (Box  210 );   Adjusting the width of the channel (Box  212 );   Adjusting the baffling of the cell (Box  214 );   Querying whether another cell is to be autocalibrated (Query  216 );   If Query  216  is positive, removing and relocating the cell in the system (Box  218 );   If Query  216  is negative, query whether cell is to remain in the autocalibration station during operation (Query  220 );   If Query  220  is positive, the cell remains in place (Box  222 ) and may be used for dispensing;   If Query  220  is negative, relocating the cell to another dispensing location (Box  224 ).       

     The calibration process described in  FIG.  7    is carried out by inserting the cell  63  that requires calibration into the autocalibration station  100 . Referring now to  FIGS.  8  and  9   , the autocalibration station  100  includes upper and lower substations  102 ,  103 , each of which receives a cell  63  (or, alternatively, the substations  102 ,  103  may receive a single “supercell,” which is configured as a single container that is the size of two cells  63  vertically stacked—see U.S. Pat. No. 7,870,973, supra). Each of the substations  102 ,  103  includes guide arms  104  that guide the cells  63  into proper position. Each of the substations  102 ,  103  also includes an air connection port  106 ,  122  that engages a port  74  on the cell  63  to provide a fluid connection to the air manifold of the system  40 , and further includes an electronics block  107 ,  124  to enable the controller  42  of the system  40  to communicate with the cell  63  via a PCB (not shown) on the cell  63 . 
     The lower substation  102  further includes a horizontal adjustment driver  110 . The horizontal adjustment driver  110  is positioned to engage the horizontal adjustment knob  76  located on the side of the cell  63  that adjusts the width of the channel of the cell  63 . In addition, the lower substation  102  includes a vertical adjustment driver  112  that is positioned to engage the vertical adjustment knob  78  located on the floor of the cell  63 . Also, a baffle adjustment driver  114  is present to adjust baffles  73  present in the cell  63  via the baffle adjustment mechanism  71 . Each of the adjustment drivers  110 ,  112 ,  114  is mounted on a movable platform that enables the drivers  110 ,  112 ,  114  to be conveyed into an engagement position and retracted into a disengaged position. Each of the adjustment drivers  110 ,  112 ,  114  is operatively connected to the controller  42 . 
     When the user is conducting a calibration procedure on a cell  63 , once the user has identified the pills to be stored in and dispensed from the cell  63  (as in Box  202  above—typically with a bar code scanner  130 —see  FIG.  3   ), the system  40  receives cell setting information from the database. The controller  42  signals the adjustment drivers  110 ,  112  to engage and rotate the knobs  76 ,  78  to the positions dictated by the cell setting information of the pills (Boxes  210  and  212 ), and signals the baffle driver  114  to adjust the baffle via the baffle adjustment mechanism  71  (see Box  214 ). Once rotation of the knobs  76 ,  78  has driven the walls of the channel inlet  69  to the prescribed positions and the baffle adjustment mechanism  71  has positioned the baffle, the drivers  110 ,  112 ,  114  disengage from the knobs  76 ,  78 , and baffle adjustment mechanism  71  and the cell  63  is in condition for use. Alternatively, the system may use pill dimension information to automatically determine cell settings based on the pill dimensions; the controller  42  may then signal adjustment of the drivers  110 ,  112 ,  114 , as above, based on the determined cell settings. 
     The pill dimension information may be retrieved from the database, or entered into the system during operation, either manually by the user or automatically via an automated pill measurement mechanism, such as a set of calipers or an imaging system. 
     Notably, a cell  63  that has been calibrated in the lower substation  102  may remain in the location and be used to dispense pills during normal operation of the system  40 . As such, the system  40  is able to provide this additional dispensing location to increase system capability (see Box  222 ). The cell  63  may also be removed after calibration and moved to another dispensing location of the system  40  (see Box  224 ) or the upper substation  103 , which may be required if one or more additional cells  63  is in need of calibration. 
     The upper substation  103  has no adjustment drivers. As such, a single cell  63  is not mounted therein for the purposes of calibration. However, the upper substation  103  can be used as an additional dispensing location for a cell  63 ; it includes an air connection port  122  and an electronics block  124  that connect with the port  74  and PCB of a cell  63  to provide the needed fluid and electronic communication to the cell  63 . In addition, the port  122  and electronics block  124  of the upper substation  103  can also serve as the communication port when a “supercell” (as discussed above, a single container that is the size equivalent of two cells  63  in a vertically stacked configuration) is being calibrated. The supercell will have a fluid port and a PCB that will engage the port  122  and electronics block  124  of the upper substation, and will also have the horizontal and vertical adjustment knobs that can be adjusted with the horizontal and vertical adjustment drivers  110 ,  112  and baffler adjustment driver  114  of the lower substation  102 . 
     As can be understood from the foregoing, the system  40  can provide an autocalibration capability to facilitate calibration and recalibration of cells, and can do so while providing additional dispensing locations during operation. These combined capabilities capitalize on the available space of the system  40 , which can be important in pharmacies where space may be at a premium. 
     Moreover, the location of the autocalibration station  100  within the system  40  can be advantageous. More specifically, the autocalibration station  100  resides just underneath the bar code scanner  130  and between equal arrays of cells  63 . As a result, the bar code scanner  130  (which is often attached to the system  40  via a cord) can reach the autocalibration station  100  and any of the cells  63  with a relatively short cord. 
     It should also be noted that, in some instances, the autocalibration station  100  may operate during the autocalibration process without air being introduced into the cells  63  mounted therein. In such instances, the cell  63  is typically devoid of pills during autocalibration to ensure that the pills do not interfere with the autocalibration process. Thus, if pills were initially present in the cell  63  to be autocalibrated, the pills would be removed, the autocalibration process would proceed as discussed above, the cell  63  may be tested with a subset of the pills previously removed, and, assuming a positive test, the pills would be returned to the cell  63 . However, it is also contemplated that air may be introduced into the cell  63  in a reversed manner (such that the airstream is directed from the channel  65  of the cell  63  back through the channel inlet  69  and into the main chamber of the cell  63 ). In such an instance, the reverse airflow may prevent pills from reaching the channel inlet  69  and, as such, may prevent interference of the autocalibration process by the pills. Allowing the pills to remain in the cell  63  during autocalibration (rather than having to refill the cell  63  after autocalibration) may reduce labor steps and time associated with autocalibration considerably: the pills would already be present in the cell  63  for any post-autocalibration testing, and would still be present should the testing need to be repeated (e.g., if a second autocalibration process and a second test were needed following a first test failure). The patents incorporated by reference above describe the use of a reverse air stream (used in normal counting operations to end the count and/or to rectify a pill jam in the channel  65 ) that may be employed during autocalibration. 
     Another embodiment of an autocalibration station is shown in  FIGS.  12  and  13    and designated broadly at  100 ′. The autocalibration station  100 ′ is similar to the autocalibration station  100 , but further includes an interlock system  200 . The interlock system  200  includes a pivoting lock lever  202  pivotally mounted on brackets  204 . The lock lever  202  is generally U-shaped, with a main member  205  and two arms  206  mounted to the brackets  204  at a pivot axis  208 . A tab  210  extends laterally from one of the arms  206 . A proximity switch  212  is mounted near the top of one of the brackets  204 . 
     In operation, the lock lever  202  is pivoted to a lowered position, in which the main member  205  is below the pivot axis  208 . A cell  63  is mounted in the autocalibration station  100 ′ in the manner described above. The lock lever  202  is then pivoted about the pivot axis  208  to a raised position (see  FIGS.  12  and  13   ), in which the lock lever  202  engages the cell  63  to secure it in place. In this position, the tab  210  is positioned just above the switch  212 , thereby activating the switch  212 . Activation of the switch  212  enables autocalibration to proceed; if the switch  212  is not activated, operation will not occur, and if the system was already operating, the drivers  110 ,  112 ,  114  will withdraw. The presence of the interlock system  200  assures that the system ceases operation if an operator attempts to remove a cell  63  as it is undergoing calibration. 
     Those of skill in this art will appreciate that the system may take other forms. For example, while an airstream is used as the primary generator for dispensing, the system may employ other methods (e.g., purely mechanical and electromechanical systems). The adjustment drivers may vary in configuration. In some embodiments, not all of the height, width and baffle position may require adjustment. 
     The foregoing is illustrative of the present invention and is not to be construed as limiting thereof. Although exemplary embodiments of this invention have been described, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the claims. The invention is defined by the following claims, with equivalents of the claims to be included therein.