Patent Publication Number: US-2019185249-A1

Title: Rotable cap system for dispensing one or two tablets or capsules from a pharmacy vial

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation-in-part of U.S. patent application Ser. No. 15/194,513, filed Jun. 27, 2016, which claims the benefit of U.S. patent application Ser. No. 14/545,888, filed on Jun. 26, 2015, and U.S. patent application Ser. No. 14/756,555, filed on Sep. 17, 2015. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates to a bottle cap design to facilitate the dispensing of tablets or capsules from a bottle such as a pharmacy vial or a food container with pelletized food items. The inventive bottle cap design employs an inner and outer cap rotatably connected with a perforation in each cap that permits the dispensing of only one or two tablets or capsules at a time from a pill bottle when the bottle is tilted in a single action. 
     BACKGROUND 
     In pill bottles such as bottles containing tablets and capsules (i.e., “pills”), the contents are normally dispensed by removing the cap and tilting the bottle to one side. For persons with limited dexterity, for example from arthritis, or movement disorders such as Parkinson&#39;s Disease or essential tremor, it can be a challenge to dispense one or two pills from a bottle without spilling the entire contents. Typically, patients only use one or two pills at a time from a pharmacy bottle. 
     The difficulty of opening and dispensing pills from pharmacy bottles is an art-recognized problem. See, for example, A. Beckman et al., “The difficulty of opening medicine containers in old age: a population-based study,”  Pharm World Sci.  2005, 27(5), 393-8, DOI: 10.1007/s11096-005-7903-z; K. Nortenboom et al., “Practical Problems with Medication Use that Older People Experience: A Qualitative Study,” J. Am. Geriatrics Soc. 2014, 62, 2339-2344, DOI: 10.1111/jgs.13126. Nortenboom specifically calls out the difficulty of removing medicine from a bottle, the problem addressed by this invention. 
     Pill bottles with various safety cap designs are well known. See, for example, U.S. Pat. No. 8,267,265. Most of these are either difficult to operate, for example, child resistant caps requiring certain force to open the cap or once opened they allow unrestricted access to the pills inside the bottle. This results in unnecessary access to entire contents of the bottle as well as unintentional spillage of pills, a particular problem for persons with a movement disorder. 
     The use of a choke to narrow the opening of a bottle is well known with powdered products such as spices. See, for example, U.S. Pat. Nos. 4,437,593, 4,449,638, and 5,213,238. These products are intended for the controlled dispensing of larger objects that do not flow freely, such as tablets, capsules, or pelletized food items. 
     In addition, various specialty cap designs may be of value for pelletized food items, such as chewing gum products or candy, for example “M&amp;M®” candy, that limit the egress of the food product from the packaging. 
     SUMMARY OF THE INVENTION 
     This invention provides means to limit the egress of pills from a pharmacy vial, particularly for the benefit of mobility impaired persons. In addition, this device may have utility to limit the egress of pelletized food items from a food package. 
     Accordingly, a cap assembly is provided for limiting the egress of tablets or capsules from a pharmaceutical bottle containing tablets or capsules. In an embodiment, the assembly may include an inner cap having a first top panel with an extended shoulder, a first opening contained in the first top panel, and a first skirt extending downward from the first top panel, the first skirt having an inner surface with a mechanism for engaging a neck of the bottle. The assembly may also have an outer cap over the inner cap, wherein the outer cap engages the inner cap, wherein the outer cap has a second top panel, and a second opening in the second top panel, wherein the second opening is approximately the same size and shape as the first opening, and a second skirt extending downward from the second top panel, the second skirt having an inner surface with a mechanism for engaging the inner cap and an outer surface with one or more ridges for providing a non-slip grip. In an embodiment, the outer cap is rotatable relative to the inner cap between a first position wherein the openings are not aligned, and a second position wherein the second opening aligns with the first opening. In an embodiment, when the outer cap is in the second rotable position, when the bottle is tilted in a single movement, one or two tablets or capsules are dispensed through the aligned openings. The same principle of operation applies if the bottle or other package contains a pelletized food item. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a cross-section view of a pill bottle cap with a two-cap assembly, in accordance with one embodiment of the invention, shown in an installed and locked position on the pill bottle. 
         FIG. 1A  is a perspective view of a pill bottle of this invention, showing the openings in the inner and outer caps to allow pills to dispense from the bottle. 
         FIG. 1B  is a perspective view of a pill bottle of this invention, showing the openings in the inner and outer caps out of alignment. 
         FIG. 1C  is a view of the bottle cap only, showing the openings of the inner and outer cap in an oval-shaped embodiment. 
         FIG. 2A  is a cross-section view of a pill bottle cap and the bottle showing an inner cap of the two-cap assembly of  FIG. 1 , in accordance with one embodiment of the invention. 
         FIG. 2B  is a top plan view of the inner cap of  FIG. 2A , in accordance with one embodiment of the invention. 
         FIG. 3A  is a cross-section view of a pill bottle cap and the bottle showing the two-cap assembly of  FIG. 1  in an unlocked position, in accordance with one embodiment of the invention. 
         FIG. 3B  is a top plan view of the two-cap assembly of  FIG. 3A , in accordance with one embodiment of the invention. 
         FIG. 4A  is a perspective view of a pill bottle cap and the bottle showing the two-cap assembly of  FIG. 1  in a locked position, in accordance with another embodiment of the invention. 
         FIG. 4B  is a top plan view of the two-cap assembly of  FIG. 4A , in accordance with another embodiment of the invention. 
         FIG. 4C  is a cross-sectional view of the two-cap assembly of  FIG. 4A , in accordance with another embodiment of the invention. 
         FIG. 5A  is a cross-section view of a pill bottle cap and the bottle showing the two-cap assembly of  FIG. 1  in a locked position, in accordance with yet another embodiment of the invention with a push-to-turn feature. 
         FIG. 5B  shows the inner cap with a push to turn embodiment, including locking lug  110   m.    
         FIG. 5C  shows the cap from  FIG. 5B  but in an upside-down view to show lugs on the interior surface of skirt  110   b.    
         FIG. 5D  shows an upside-down view of the outer cap of the embodiment of  FIGS. 5A-5C , showing a lug on the interior surface of the skirt  120   b.    
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The term “pill” as used herein refers to pills, tablets, capsules, caplets and other such solid medicine forms. The term “bottle” as used herein refers to bottles or vials, and any such other container with a cap that holds pills or a pelletized food item. 
     An embodiment of this invention is shown in  FIG. 1 , illustrating an exemplary pill bottle cap assembly  100 . The cap assembly  100  includes an inner cap  110  and an outer cap  120 . Outer cap  120  is rotatable relative to inner cap  110 , such that a single opening in each cap can come into alignment when outer cap  120  is rotated. The inner cap contains a single opening  115  for dispensing pills. As depicted in  FIGS. 1A and 1B , the opening is triangular, but other shapes are possible, for example an oval shape shown as  116 / 126  in  FIG. 1C . In an embodiment, the outer cap  120  has a similarly shaped and sized single opening  125  or  126  as opening  115  or  116 . 
     The cap assembly  100  fits over a bottle, vial, or other package with a rigid neck  210 , such as a pill bottle  200 . Cap assembly  100  includes an inner cap  110  and an outer cap  120 . Inner cap member  110  includes a skirt  110   b  that envelopes neck  210 . Skirt  110   b  further includes means for engaging neck  210  to securely affix inner cap  110  to neck  210 . In an embodiment, inner cap  110  engages threads  211  on the bottle neck  210 . Other engagement means are known to persons of skill in the art for securely engaging a cap member to the neck of a bottle, for example a system of lugs and snaps. 
     Outer cap  120  fits over inner cap  110 . Outer cap  120  includes a top surface  120   a  with an opening  125  or  126  for dispensing the pill or pelletized food product. In an embodiment, opening  125  or  126  is approximately the same size and shape as opening  115  or  116  in inner cap  110 . Top surface  120   a  may have some flex and can bow slightly inward, which may be necessary in some embodiments of the engagement mechanism between  120  and  110 . Outer cap  120  also includes an outer skirt  120   b  that envelopes the inner skirt  110   b.    
     When the openings  115 / 116  and  125 / 126  in both caps are aligned with each other and the opening  215  of the bottle, the bottle is unlocked and the pills from the bottle may be dispensed when the bottle is tilted. Thus, the outer cap is rotatable relative to the inner cap between a first position wherein the openings  115 / 116  and  125 / 126  are not aligned, and a second position wherein the second opening  125 / 126  aligns with the first opening  115 / 116 . The rotatability of the outer cap  120  is illustrated in  FIGS. 1A and 1B . In  FIG. 1A , the caps are in the aligned orientation. In  FIG. 1B , outer cap  120  is positioned to that opening  125  is not aligned with opening  115 , shown in dashed lines. When the openings in the caps are not aligned, the package  200  is sealed shut. In an embodiment, the openings  115 / 116  and  125 / 126  are sized such that only one or two tablets, capsules, or food pellets will pass through the opening. In an embodiment this may require different sized openings for different products to achieve the desired degree of egress. 
     In an embodiment, non-slip grip ridges  122  are provided on the exterior of the skirt  120   b  of outer cap  120 . 
     The outer surface of skirt  110   b  includes means for engaging outer cap  120 . In an embodiment, outer cap  120  is not normally removed from inner cap  110 . In an embodiment, inner cap  110  includes an extended shoulder  110   g  ( FIGS. 2A and 3A ) that engages the outer cap. Other engaging means are possible. In an embodiment, the outer surface of skirt  110   b  has one or two locking lugs  110   m  ( FIG. 5A ) with a locking notch  110   q  and a tab  120   f  positioned on the inner surface of outer skirt  120   b  that fits into the locking notch, such that the outer cap must be depressed before the other cap can rotate. In an embodiment, locking lug  110   m  also has a stop  110 r that prevents the outer cap from freely rotating past that point. In an embodiment with two locking lugs  110   m , the outer cap will only be able to rotate 180 degrees before tab  120   f  engages a stop  110   r.    
     The action of depressing outer cap  120  before it will rotate, as described in the foregoing paragraph, may satisfy the child resistant packaging requirements in 16 CFR 1700, to reduce the likelihood of a young child or an incompetent person from rotating outer cap  120  and accessing the contents of the pharmaceutical vial without supervision. 
     The design of the cap assembly with the reduced dispensing opening defined by openings  115 / 116  and  125 / 126  allows only one or two pills to be dispensed each time when the bottle is tilted to the side by a user. In an embodiment, the size of the opening accommodates only one pill at a time. In another embodiment, the size of the opening accommodates only two pills. For example, opening  115  may be ½ inch by ¾ inch and opening  125  may be 17/32 inch by 13/16 inch. This minimizes any accidental or unintentional spillage of pills. Pills are accessed by the user by rotating or twisting the individual assembled caps  110  and  120  to align the openings  115  and  125  in the two-cap assembly. A counter-rotation or twist of the outer cap recloses the openings. The two caps in the cap assembly  100  can be scaled up or down to adapt to any size or any shape pill bottle. To further reduce pill spillage, the user can intentionally misalign one of the cap openings thereby reducing the open area for pill dispensing. 
       FIGS. 1A and 1B  are perspective views of the inventive cap assembly in place on a pill bottle  200 . The outer cap  120  is visible on the top of the bottle. In  FIG. 1A , the inner and outer caps are aligned such that openings  115  and  125  are aligned. In this position, tilting the bottle one side controls the egress of pills from the bottle, so that only one or two pills are dispensed at a time.  FIG. 1B  shows the outer cap twisted relative to the inner cap so that the openings  115  and  125  are not aligned. Opening  115  is depicted in dashed lines indicated it is hidden from view. In this position, the top of the bottle is sealed. Thus,  FIG. 1B  is the normal closed position used when the bottle is in storage. 
       FIG. 2A  is a cross-section view of a pill bottle cap and the bottle showing only the inner cap  110  of the two-cap assembly  100  of the invention. The inner cap  110  comprises a top panel  110   a  and a side skirt  110   b  extending downwards from the top panel for covering and sealing the bottle at its threaded neck. The top panel may have an extended shoulder  110   g  that engages outer cap  120 . In an embodiment, the inner cap  110  may have one or more raised areas  110   c  molded into the top of the cap to provide moisture resistance to the cap seal, e.g., one or more moisture seal rings. The inner cap may have a mechanism for engaging the bottle neck. For example, the inner cap may have one or more ridges or snap locks  110   d  for engaging the threads, neck ring, snap ring, snap lock or lugs of the bottle neck, depicted generically as  212  in  FIG. 2A .  FIG. 2B  shows a top plan view of the inner cap  110  with a rounded triangular opening  115 . The inner cap may have a plurality of locking pockets  110   d . The inner cap may have snap locks, e.g., four snap locks  110   f  as shown in  FIG. 3B . The inner cap will move a set distance before it locks depending on the size and shape of the bottle neck. These adjustments are well-known in the art. 
       FIG. 3A  is a cross-section view of a pill bottle cap and the bottle showing the outer cap  120  of the two-cap assembly  100  in an unlocked or open position, in accordance with one embodiment of the invention.  FIG. 3B  shows a top plan view of the outer cap  120  with the rounded triangular opening  125  in near alignment with inner opening  115 .  FIG. 3A  shows and embodiment of an engagement mechanism between inner cap  110  and outer cap  120  with one or more grooves  120   c  or molded drive lugs  120   d  that snap over the extended shoulder  110   g  of the top panel of the inner cap and hold the outer cap in place while rotating freely. For example, the outer cap may have six locking drive lugs. In a further embodiment, a moisture seal may be interposed between the inner and outer caps. 
     With reference to  FIG. 4A , another embodiment of the two-cap assembly  100  is shown in a vial  200  without a threaded neck.  FIGS. 4B-4C  show alternate views of the two-cap assembly of  FIG. 4A . In this embodiment, four snap locks  110   f  on the inner cap  110  are designed to snugly snap over a neck ring or snap ring  218  of on the neck of the vial. A snap lock  110   f  is shown on the inside surface of inner cap  110 . Drive lug  120   d  is depicted (in dashed lines) on the inside surface of outer cap  120 , engaging outer cap  120  and inner cap  110 . Note too in the embodiment shown in  FIGS. 4A and 4C  that the rim  215  of vial  200  nests inside a circumferential groove in  117  and an inner neck member  117   a  nests inside the rim of the vial. 
     With reference to  FIG. 5A , the two-cap assembly  100  is shown in a locked position, in accordance with another embodiment of the invention particularly suited to a child resistant opening. This embodiment depicts a circumferential ring  218  and lugs  110   f  that engage the inner cap  110  to vial  200 . In this embodiment, the outer surface of inner cap skirt  110   b  has locking lugs  110   m  with a shape as shown, with notch  110   q  and stop tab  110   r . In this embodiment, the tabs  120   f  on the inside surface of outer cap skirt  120   b  are designed to interact with lugs  110   m  (i.e., seats) on the outer surface of skirt  110   b . In the locked position, tab  120   f  is seated in notch  110   q  and outer cap  120  is locked in position. Simply rotating outer cap is not possible. In order to rotate outer cap  120  and expose the openings in alignment, outer cap  120  must be depressed and rotated at the same time. This forces tab  120   f  downward and away from tab stop  110   r . Conventional pharmacy vials may have 4-6 similar locking lugs, but in this invention the outer cap  120  is not disengaged from inner cap  110 , and the holes e.g.  115 / 125  must be brought into alignment, so there can only be one to three lugs  110   m . With two lugs  110   m , the outer cap  120  is rotatable 180°. 
     This embodiment is shown in further detail in  FIGS. 5B-5D .  FIG. 5B  depicts the inner cap without the outer cap, showing locking lug  110   m  on skirt  110   b .  FIG. 5C  is view of inner cap  110  upside down, i.e., the top panel is at the bottom. This also shows lug  110   m .  FIG. 5D  shows an upside-down view of outer cap  120  detached from inner cap  110 , showing tab  120   f  in the inside surface of skirt  120   b.    
     Thus, the two-cap assembly provides a user with a reduced opening for dispensing that minimizes accidental spillage of pills. The actual opening may be set to only be big enough for one pill. Or it may be adjusted to a smaller opening to deliver only one or two pills, regardless of the pill size, by intentionally not fully aligning the cap openings. In the normal closed or locked position, the opening  125  in the outer cap is fully out of alignment with the opening  115  in the inner cap. The inner cap is designed to be firmly tightened or snapped into place using either the threaded or four snap or six snap cap lock design depending on the bottle style. The inner cap may be configured so that it does not need to be removed once properly in place. The outer cap  120  may have finger grip ridges on the outside of the cap edge to provide a non-slip grip so that the reduced pill opening on the inner cap comes into alignment for quick and easy pill dispensing. A gentle twist of the outer cap recloses the pill bottle. The cap assembly may be disposable and discarded when the pill bottle is empty. The cap assembly of the invention may be installed by pharmacists when completing a prescription or installed by a user on any existing pill bottle.