Abstract:
A method and apparatus for singulating individual product items, such as pills, in unit-dose or multi-dose dispersing packaging that utilizes a pill-filling mechanism for reducing a large amount of bulk pills to a single-file stream of pills; a pill separation mechanism for singulating a variety of different sized and shaped pills; and a mechanism for delivering pills to a package, such as a blister-pack. Bar-code scanning and identification software may also be implemented to adjust the mechanisms to adapt the apparatus to different pills as they are presented to the apparatus.

Description:
[0001]     This application claims the benefit of U.S. Provision Application No. 60/574,621, filed May 26, 2004. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates generally to methods and apparatus for handling individual product items and articles. More particularly, it relates to a method and apparatus for singulating individual product items in unit-dose or multi-dose dispensing applications for medication and/or for non-medication product item delivery.  
       BACKGROUND OF THE INVENTION  
       [0003]     Frequently, small product items, and in particular pharmaceuticals such as pills, tablets, capsule, nutriceuticles (vitamins) and lozenges are packaged in blister packs where each pocket of the package holds a single pill. For ease of reference, any of the above and other small items or objects that may be required to be singulated will be referred to, collectively and generically, as “pills.” Blister packs are made by forming a thermoplastic strip formed as an array of upwardly open pockets. A filling machine then puts a single pill into each pocket and a backing to the array of pockets is provided thereby sealing each pill in a pocket separate and apart from other pills within the pack.  
         [0004]     In order to make sure that each blister package is marketable, each of the blister pack pockets must contain a single pill or the package is marked as a reject and culled from the product line. The field of pill-dispensing features many different mechanisms that are designed to recognize, sort and count tablets and capsules of all types and sizes. Many of these devices are unreliable for two basic reasons. Either they fail to singulate pills appropriately and multiple pills are placed into a single blister pack pocket or they fail to get a pill into the blister pack, leaving the entire pack one pill or more short. Such a failure is expensive when the product itself is expensive or difficult to dispose of, as is the case with many pharmaceuticals. The problem associated with separating pills from each other for individual packaging, or singulation, is exacerbated by the wide variety of different sizes, shapes and weights of different types of pharmaceuticals.  
         [0005]     In order for one apparatus to properly recognize and singulate differently-sized pills, for instance, it has often been necessary to modify the design of the dispenser machine so as to accommodate pills of particular shapes and sizes. Additionally, frequent adjustments must be made to a dispenser machine during the operation thereof. Such changes greatly inhibit the use of such devices in facilities that are automated or are continuously run.  
       SUMMARY OF THE INVENTION  
       [0006]     In view of the above-described problems, the present invention discloses a new method and apparatus that is both reliable and able to handle a wide variety of different sizes and shapes of pills without requiring adjustments to or modification of its basic design. Additionally, the current invention comprises a standardized module that can be easily loaded from a hopper that can feed pills of varying sizes and shapes. In this manner, a single workstation can sort and dispense a wide variety of pills as needed in almost any sort of prescription filling facility. Additionally, this invention is more cost-effective, faster and more versatile than existing dispensers.  
         [0007]     The method and apparatus of the present invention provides for a centrifugal pill separator comprised of three major subsystems, a pill filling mechanism capable of reducing a large amount of bulk pills to a single file stream of pills; a pill separation apparatus capable of singulating a wide variety of differently sized and shaped pills; and a delivery means for placing singulated pills into a blister pack. The centrifugal pill dispenser may also include bar code scanning and identification software such that the pill dispenser can be automatically adjustable so as to quickly adapt to a wide variety of pills as the pills are presented to the apparatus.  
         [0008]     The centrifugal pill dispenser of the present invention may also provide for a filling mechanism consisting of a hopper to store pills and a dispenser to control the flow of pills to the pill separation mechanism. The present invention further provides for a self-regulating filling mechanism such that when the pill level in the pill dispenser rises above a certain height, the continued flow of pills is stopped. Additionally, the present invention may provide for a pill delivery means having either a single aperture or a plurality of apertures for permitting pills to exit onto the centrifugal separator; said apertures opening and closing in response to the pills present on the centrifugal separator. The present invention may also provide for the apertures having the ability to provide a variably sized aperture for differently sized pills.  
         [0009]     In the case of some pill types, continuous pill flow is hampered by pill size or shape. In such situations, the present invention provides for agitation of the pills within the filling mechanism to prevent potential slowdowns in the dispensing and packaging process. One potential agitation means includes the use of rotating vanes.  
         [0010]     The present invention also provides for the use of a centrifugal pill separation mechanism consisting of a rotating disk having a plurality of concentric rings surrounding it. The rings contain channels which permit the passage of individual pills there through. In one embodiment, there are eleven channels, although either more or fewer channels are possible. The eleven channels permit the simultaneous capture and singulation of eleven pills.  
         [0011]     The present invention also provides for a pill distribution and dispensing method and apparatus designed to fill a blister pack. The present invention will reduce or eliminate incidents of multiple pills in a single packet of a blister pack as well as the chance of empty pockets in a blister pack, thus reducing costly and difficult to dispose of pharmaceutical waste.  
         [0012]     The present invention also provides for the use of bar code technology to adapt the pill dispensing apparatus to a broad variety of pills. Initially, the present invention provides for the creation of and use of a database including information as to the physical dimensions of individual pills. Each type of pill would then be assigned a unique, machine readable code or drug related NDC code that could be easily scanned by an optical instrument, the machine readable code being displayed prominently on containers containing pills. A microprocessor in the pill dispensing mechanism would then provide for changing the settings on the centrifugal pill dispenser to accommodate a particular pill. For example, the rotational speed of the disk may be changed, as could the depth of entry of the pills, the alignment of certain types of pills and the amount of pills to be singulated.  
         [0013]     In summary, the method and apparatus of the present invention provides a basic design that is capable of singulating a complete range of pill sizes and shapes, without requiring different mechanical operations or adjustments. While some objects of the invention have been discussed above, other objects and advantages of this invention will become apparent from the following detailed description in conjunction in the drawings, which set forth certain embodiments of the present invention. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0014]      FIG. 1  is a top and side perspective view of the pill separation subsystem of the pill dispenser.  
         [0015]      FIG. 2  is a bottom and side perspective view of the pill separation subsystem of the pill dispenser.  
         [0016]      FIG. 3  is a cross-sectional view of the pill separation subsystem and the pill filling subsystem of the pill dispenser  
         [0017]      FIG. 4  is a cross-sectional view of the pill separation subsystem of the pill dispenser.  
         [0018]      FIG. 5  is an expanded cross-sectional view of the pill separation mechanism.  
         [0019]      FIG. 6  is a side and bottom view of the indexing disk.  
         [0020]      FIG. 7  is a top and side view of the pill separator subsystem having the pill guide slots in the open position.  
         [0021]      FIG. 8  is a cross-sectional view of the pill separator subsystem showing the pill guide slots in the open position.  
         [0022]      FIG. 9  is a top and side view of the pill separator subsystem having an adjustment finger removed such that pill opening is more visible.  
         [0023]      FIG. 10  is a top and side view of the separator subsystem showing the opening through which a pill may fall.  
         [0024]      FIG. 11  is a top and side view of the separator subsystem showing the pill guide slots in the open position while the pill drop slots are closed.  
         [0025]      FIG. 12A  shows a side view of the separator disk.  
         [0026]      FIG. 12B  shows as top and side view of the separator disk.  
         [0027]      FIG. 12C  shows a top view of the separator disk.  
         [0028]      FIG. 13  shows a cross-sectional view of the separator subsystem.  
         [0029]      FIG. 14  is a top schematic view of the function of the vanes in the pill filling subsystem.  
         [0030]      FIG. 15  is a top schematic view of the air flow assist across the rotating disk for excess pill ejection.  
         [0031]      FIG. 16  is a top schematic view of the air flow assist across the rotating disk.  
         [0032]      FIG. 17  is a top and side exploded view of another embodiment of the pill dispensing machine.  
         [0033]      FIG. 18  is a top and side perspective view of the retaining ring of the pill dispensing mechanism.  
         [0034]      FIG. 19  is top and side view of the nesting ring employed in the pill dispensing machine.  
         [0035]      FIG. 20  is a top view of the window adjustment ring weldment.  
         [0036]      FIG. 21  is a top, side and bottom view of the chute ring employed in the present invention. 
     
    
     DETAILED DESCRIPTION  
       [0037]     Now referring to the drawings in detail wherein like-numbered elements refer to like elements throughout,  FIG. 1  shows one embodiment of the centrifugal pill separator subsystem  23  of the pill dispenser  1  constructed in accordance with the goals of the present invention. In summary, the present invention provides an apparatus for singulating small objects, such as pharmaceuticals, and placing them into blister packs  47 . In slightly more detail, the present invention provides three subsystems for singulating pills  9 . As shown in more detail in  FIGS. 3 and 14 , the apparatus of the present invention provides for a filling mechanism  21  which is designed to provide a regular flow of pills  9  in a generally single file manner to the second stage from a supply of bulk pills, such as may be in a hopper  7 . The second stage, or pill separation stage  23 , includes the actual apparatus for singulating pills  9  via a rotating disk  25 . The third stage of the present invention provides for delivering the singulated pills  9  to the blister pack  47  and is generally referred to as the distribution mechanism  49 .  
         [0038]     As shown in detail in  FIG. 14 , the filling mechanism  21  is designed to reduce a mass of bulk pills  9  to an orderly, generally single file line of pills into the separation mechanism  23 . The dispensing mechanism provides for a hopper  7  into which bulk pills  9  are conveyed. The hopper  7  can be of nearly any design, the only requirement being that it hold a plurality of pills  9  and have the ability to convey pills  9  to the preliminary dispenser  11  in a controllable fashion. The hopper  7  is used to accumulate pills  9  in-line for the product dispenser  1 . The hopper  7  feeds pills  9  to a preliminary dispenser  11 . The preliminary dispenser  11 , in one embodiment, is generally cylindrical, and positionally, is located over the rotating disk  25 . The preliminary dispenser  11  is used to regulate the flow of pills  9  from the hopper  7  to the centrifugal pill separator  23 . This is primarily accomplished by providing for a gravity sensor  17 , the gravity sensor  17  being situated over the top of a pocket  19  into which pills  9  fall. When the pill pocket  19  is full, the gravity sensor  17  is forced upwardly by the volume of pills  9  underneath said gravity sensor  17 . When the pills  9  feed into the pill dispenser  1 , the gravity sensor  17  opens further thus assuring a continuous supply of pills  9 . While use of a gravity sensor has been discussed, other types of sensors could also be used to determine the level of pills contained within the pill pocket  19 . The sensor  19  would then send a first signal to a microprocessor  97  which could then send a second signal back to stop the flow of pills  9  into the pill pocket  19 .  
         [0039]     The pill pocket  19  of the filling mechanism  21  is also the entry point to the centrifugal separator  23 . More specifically, the floor of the pill pocket  19  is a rotating disk  25 . As the pocket  19  fills, the centrifugal force of the rotating disk  25  carries the pills  9  outwardly on the disk  25 . The rotating disk  25 , in one embodiment, could be cone-shaped such that the pills  9  are carried up the slope on the rotating disk  25  to a perimeter of the disk  25 . As the pocket  19  fills with pills  9 , the pills  9  are guided in a circular path by a flexible vane  27 . The flexible vane  27 , is generally circular, but is shown having a pair of apertures  61 ,  63  separated by 180 degrees, although more or fewer openings are possible in the vane  27 . The apertures  61 ,  63  are permitted to open and close. When open, the vane  27  permits pills  9  to exit the pill pocket  19 . Generally, the vane  25  opens wide enough such the pills  9  are released in a single file orientation. Additionally, the vane  27  would only remain open long enough to release a fixed amount of pills  9 , such as an amount necessary to fill a blister pack  47 , from the flexible vane  27 . The opening and closing of the apertures  61 ,  63  could be controlled by a sensor, or perhaps by a simple timer, such that the amount of pills  9  released is merely estimated. As the pills  9  reach the edge of the disk  25 , they circulate to the perimeter of the disk  25 . When enough pills  9  are circulating, the flexible vane  27  closes. Additionally, the flexible vane  27  is variably openable. That is, in the case of smaller pills  9 , or even elongated pills  9 , the vane  27  may only open to permit the passage of a single pill  9 , or, in the case of an elongated pill  9 , such as a capsule, to only permit passage in a specific orientation.  
         [0040]     Surrounding the perimeter of the disk  25  is a separator disk  35 . The separator disk  35  has a plurality of apertures  51 . The separator disk aperture  51 , in general, aligns; with the apertures, or pill guide slots  31 , in the separator wall  29  when the separator wall  29  is in the open position and are completely blocked by the separator wall  29  when the separator wall  29  is in the closed position. The separator wall  29  has a flange, or release ring  33 , which, if the separator wall  29  is considered to be vertical, the release ring  33  is considered generally at 90 degrees from said separator wall  29 . The separator wall  29  additionally has a cam slot  39  which, when the separator wall  29  is rotated, lifts the separator wall  29  thus exposing the pill guide slots  31  and aligning them with the apertures  51  of the separator disk  35 . The pill guide slots  31  are in the separator wall  29  and serve to guide the entry of the pills  9  such that the pills  9  enter the pill guide slots  31  located physically over the pill drop slots  37 , which may be considered to be located in the release ring, or flange  33 . The pill guide slots  31  are located between the guides  13 . The guides  13  are situated on or at an angle to the rotating disk  25 , preferably at an angle tangent to the rotating disk  25  such that the pills  9  enter the pill drop slots  31  created by the guides  13  in the most expeditious manner. The guides  13  are shown accommodating a specific size pill  9 . The guides  13  could be narrower so as to create wider pill drop slots  31  and thus to accommodate larger pills  9 . Similarly, the guides  13  could potentially be wider and create narrower pill drop slots  31  which would aid in pill  9  singulation in the event smaller pills are required to be singulated.  
         [0041]     As discussed above, the release ring  33  is located circumferentially outside of the pill guide slots  31 , and, in general, the pills  9  will be resting on the release ring  33  after they are singulated into the pill drop slots  31 . The release ring  33  has a plurality of apertures, or pill drop slots  37 , the drop slots  37  permitting passage of a pill  9  through the drop slots  37  in the release ring  33  after the separator wall  29  has opened and permitted entry of a pill  9 . The pill drop slots  37  in the release ring  33  provide entry for the pills  9  to the indexing disk  65 .  
         [0042]     The pills  9  then pass through the distribution mechanism generally identified  49 , which can be understood as consisting of three disks. Initially, there is the stop ring  45 , then the dispensing ring  53 , and lastly the indexing disk  65 . The stop ring  45  is used to block any or all of the plurality of pills  9  in the pill drop slots  31  from dropping into the indexing disk. The stop ring  45  may be especially important in filling a blister pack  47  with pills  9  when the blister pack  47  has a number of blisters that is not a multiple of the number of pill drop slots  31 . Immediately below the stop ring is a guide chute  73  for controlling the drop of a pill  9  through the channels  41  in the dispensing ring  53 . The guide chute  73  and dispensing ring  53  align the pills as they travel to the indexing disk  65 . The dispensing ring  53  may include a pressured air assist to ensure that pills drop uniformly through the channels  41 .  
         [0043]     The indexing disk  65  has a plurality of apertures  69 , generally corresponding to a multiple of the number of pill guide slots  31  and separator disk apertures  51 . Therefore, as the disk  25  rotates, the pill guide slots  31  begin to fill with pills  9 . When the guide slots  31  each contain a pill  9 , the separator wall  29  rotates following the cam slot  39  and cam  67 , thus closing the pill guide slots  31  and exposing the pill drop slots  37  and permitting the pills  9  to drop into the apertures  69  of the indexing disk  65 . The indexing disk  65  is then triggered by the microprocessor  97  to index one time such that each pill drop slot  37  corresponds to a new aperture  69  in the indexing disk  65 . The base of the indexing disk  69  is covered by a shuttle plate  75 , said shuttle plate releasing all the pills  9  simultaneously through tubes  77  to a blister pack  47 . The shuttle plate  75  may also release the pills  9  to a lower holding plate  79 , or yet another shuttle plate, whereupon they enter the blister pack  47 .  
         [0044]     As previously discussed, there exists a wide variety of pill  9  sizes, shapes and types. Therefore, the present invention provides for a plurality of adjustable features, in addition to the aforementioned, including differently sized guides  13 . Additionally, the bar code information can include adjustment as to the depth in the pill guide slot  31  of the adjustment fingers  43 . The adjustment fingers  43  are preset to an appropriate depth depending on the size and shape of the pill  9 . The adjustment fingers  43  are adjustable using the combination of a stepper motor (not shown) and a linkage arm  71  connecting the stepper motor and the adjustment fingers  41 .  
         [0045]     Obviously, the frictional relationship between the rotating disk  25 , the pills  9  and the separator wall  29  is very important to the operation of the apparatus of the invention. For example, if friction from the separator wall  29  is too high, pills  9  may tumble along the separator wall  29  as opposed to sliding along the separator wall  29 . Pill  9  tumbling action reduces the likelihood that the pills  9  will enter the pill guide slots  31 , thus increasing the amount of time it takes to fill the pill guide slots  31  along the separator ring  29 .  
         [0046]     Conversely, the friction between the rotating disk  25  and the pill  9  must be greater then the friction between the separator wall  29  and the pills  9 , or the pills would not move along the separator wall  29  at all. Also, the centrifugal force on the pill  9  due to rotation should be greater than the frictional force stopping the pill  9  from moving outwardly on the rotating disk  25 .  
         [0047]     Very small pills  9  may still present an obstacle to be overcome by the method and apparatus of the present invention as described above. In that case, the present invention also provides for the use of an air assist to push the pills  9  into the pill guide slots  31 . In such cases, the air stream could be fanned out over the rotating disk  25  so as to provide an outward stream of air across the entire rotating disk  25  or streams of air could be aimed at each individual pill drop slot  31 .  
         [0048]     Singulating pills  9  within the pill drop slot  31  is also very important to prevent instances of multiple pills resulting in a blister pack  47 . Therefore, the present invention provides for an optional air assist after a pill  9  has entered the pill drop slot  31 , but before the separator wall  29  has closed, thereby sealing off the pill drop slot  31 . In effect, the air stream is used to move the pill  9 , or any additional pills behind the pill  9  in the pill guide slot  31 , such that any additional pills do not interfere with the closing of the separator wall  29 .  
         [0049]     An onboard computer or Programmable Logic Controller (PLC) controls the speed and direction in which the disk  25  spins. The disk size and speed are dependent on the size, weight, surface texture and coefficient of friction between the pill to be filled and the package size being processed. The pill dispenser is electromechanically connected with both the packaging machinery downstream and a computer to provide means for tailoring the pill dispenser to a specific application.  
         [0050]      FIG. 17  shows a detailed assembly drawing of one embodiment of the present invention showing the cam height adjustment  17 . 15  in combination with the height adjustment ring  17 . 14  which cooperate to adjust the height of the window opening the pills are directed into. Also shown is the nest subassembly  14 . 1  which provides a place to “catch” the pill. The width of the opening for the pill in the eight nest subassembly  14 . 1  is determined by the window ring weldment  14 . 4 .  
         [0051]      FIG. 14  also shows the release ring  17 . 7  which rotates to permit the pills to drop through the chutes  18 . 2  in the chute support ring  18 . 1 . Additionally,  FIG. 14  shows the pocket subassembly  17 . 1  in combination with the pill dispenser  1 . The pocket subassembly  17 . 1  is comprised of the eight pocket retainer shown in  FIG. 18  and the eight pocket nest shown in  FIG. 19 .  
         [0052]      FIG. 17  shows the window adjustment ring weldment which rotates to accommodate differently sized pills.  FIG. 18  shows the chute weldment, with the chute support ring  18 . 1  and the chute  18 . 2  through which the pills drop after entering the through the window. The pill then drops into the indexing disk.  
         [0053]     In summary, the present invention provides a method and apparatus for filling a blister pack  47  comprising the steps of: scanning a product bar code; adjusting the pill dispenser to meet the size and shape requirements of the product to be filled; permitting the passage of pills into the hopper  7 ; releasing product to the separator; centrifugally spinning the product to a plurality of gates; permitting the product to drop into the blister of a blister pack.  
         [0054]     Additionally, the present invention provides an apparatus for conveying pills in an orderly fashion to a rotating disk; capturing said pills in gates from the rotating disk and permitting the pills to drop into a blister pack.