Abstract:
A pen needle magazine dispenser for holding and dispensing a novel pen needle assembly. The pen needle magazine dispenser includes a number of threaded sleeves within cavities that interact with threads on each pen needle assembly to attach the pen needle to a special adapter on a conventional medication delivery pen. The magazine dispenser includes a sterility barrier and a cap to cover the pen needles.

Description:
BACKGROUND OF THE INVENTION  
         [0001]    1. Field of the Invention  
           [0002]    The subject invention relates to a pen needle magazine dispenser for a new pen needle and, more particularly, to a pen needle magazine that holds and dispenses sterile pen needles for medication delivery pens and that safely stores the needles after use.  
           [0003]    2. Description of Related Art  
           [0004]    Hypodermic syringes are used to deliver selected doses of medication to patients. The prior art hypodermic syringe includes a syringe barrel having opposed proximal and distal ends. A cylindrical chamber wall extends between the ends and defines a fluid receiving chamber. The proximal end of the prior art syringe barrel is substantially open and receives a plunger in sliding fluid tight engagement. The distal end of the prior art syringe barrel includes a passage communicating with the chamber. A needle cannula is mounted to the distal end of the prior art syringe barrel, such that the lumen of the needle cannula communicates with the passage and the chamber of the syringe barrel. Movement of the plunger in a proximal direction draws fluid through the lumen of the needle cannula and into the chamber. Movement of the plunger in a proximal-to-distal direction urges fluid from the chamber and through the lumen of the needle cannula.  
           [0005]    Medication to be injected with the prior art hypodermic syringe often is stored in a vial having a pierceable elastomeric seal. Medication in the prior art vial is accessed by piercing the elastomeric seal with the needle cannula. A selected dose of the medication is drawn into the chamber of the syringe barrel by moving the plunger a selected distance in a proximal direction. The needle cannula is withdrawn from the vial, and the medication is injected into a patient by moving the plunger in a distal direction.  
           [0006]    Some medication, such as insulin is self-administered. The typical diabetes patient will require injections of insulin several times during the course of the day. The required dose of insulin will vary from patient to patient, and for each patient may vary during the course of the day and from day to day. Each diabetes patient will establish a regimen that is appropriate for his or her own medical condition and for his or her lifestyle. The regimen typically includes some combination of a slow or medium acting insulin and a faster acting insulin. Each of these regimens may require the diabetes patient to periodically self-administer insulin in public locations, such as places of employment or restaurants. The required manipulation of the standard prior art hypodermic syringe and vial can be inconvenient and embarrassing in these public environments.  
           [0007]    Medication delivery pens have been developed to facilitate the self-administration of medication. A prior art medication delivery pen is identified generally by the numeral  1  in FIG. 1. Pen  1  contains a cartridge with sufficient medication for several doses. The prior art cartridge has opposed proximal and distal ends. The distal end is closed by a pierceable and resealable rubber septum identified by the numeral  2  in FIG. 1. The proximal end receives a stopper in sliding fluid-tight engagement. The prior art cartridge is disposed in an elongate pen-like body  4  with a proximal end (not shown) and an opposed distal end  6 . The proximal end of the pen body includes a plunger for selectively driving the stopper of the cartridge in the distal direction and a dose setting mechanism for determining the distance through which the plunger and stopper can move. Distal end  6  of pen body  4  includes an array of threads  8  for threaded engagement with a pen needle assembly  90 . Pen needle assembly  90  includes a needle cannula  91  with opposed proximal and distal points  92  and  93  and a threaded mounting skirt  94  which surrounds the proximal tip  92 . Mounting skirt  94  is threadably engageable with threads  8  on distal end  6  of pen body  4 . A safety shield  95  is releasably engaged over distal point  93  and portions of mounting skirt  94  to prevent accidental needle sticks.  
           [0008]    A person who must periodically inject doses of medication will carry a medication delivery pen  1  and a supply of pen needle assemblies  90 . Each pen needle assembly  90  has its needle cannula  91  safely and sterility sealed in its own shield  95 , and is accessed immediately prior to administering a dose of medication. Pen needle assembly  90  then is mounted to distal end  6  of prior art pen  1 . This mounting causes proximal point  92  of needle cannula  91  to pierce rubber septum  2  of the cartridge, to place needle cannula  91  in communication with the medication in pen  1 . Pen  1  then is used to inject the selected dose of medication. After completing the injection, needle assembly  90  is separated from pen  1  and is discarded. Pen  1  may be used repeatedly in this manner until the medication is exhausted. Such prior art pens offer many conveniences and efficiencies. However, the storage of unused needles and the final disposal of used needles has presented problems. In particular, supplies of new needles often are loosely scattered in the bottom of purses or briefcases, and used needles are often disposed of unsafely.  
         SUMMARY OF THE INVENTION  
         [0009]    The subject invention relates to a storing and dispensing apparatus for needle assemblies used with hypodermic syringes and preferably a new type of pen needle that is designed to attach to an adapter having conventional threads that mate with threads  8  on medication delivery pens.  
           [0010]    The pen needle dispenser of the present invention includes a magazine dispenser having a cover removably mounted on a container with a plurality of cavities, with each cavity dimensioned to receive a new type of pen needle assembly. The user inserts a special adapter on the medication delivery pen into one of the cavities and rotates the pen to mount an unused pen needle on the adapter on the medication delivery pen. After an injection has been performed, the used pen needle is returned to the cavity by inserting the used pen needle into the cavity and rotating the pen to detach the pen needle from the adapter on the pen.  
           [0011]    An object of the present invention is to provide a user with a convenient way to carry, dispose of and keep track of their personal pen needle usage. The pen needle magazine dispenser is designed to be carried and contain a predetermined number of pen needles in respective cavities, with each cavity being sealed by a numbered label or sterility membrane. The numbered labels indicate how many unused pen needles remain in the pen needle magazine dispenser.  
           [0012]    These and other aspects, features and advantages of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings.  
       
    
    
     DESCRIPTION OF THE DRAWINGS  
       [0013]    [0013]FIG. 1 is an exploded perspective view of a prior art pen needle and the distal end of a prior art medication delivery pen with which the present invention is intended to be used;  
         [0014]    [0014]FIG. 2 is an exploded perspective view of a cover and a pen needle magazine dispenser according to the present invention;  
         [0015]    [0015]FIG. 3 is an exploded perspective view of the pen needle magazine dispenser shown in FIG. 2;  
         [0016]    [0016]FIG. 4 is an exploded perspective view of a partially assembled pen needle magazine dispenser;  
         [0017]    [0017]FIG. 5 is a perspective view of the mediation delivery pen and pen needle magazine dispenser, when attaching or removing the pen needle from the adapter;  
         [0018]    [0018]FIG. 6 is a cross-sectional view of a sleeve in the pen needle magazine dispenser prior to attaching the pen needle to the adapter;  
         [0019]    [0019]FIG. 7 is a cross-sectional view of the sleeve in the pen needle magazine dispenser after the pen needle has been attached to the adapter; and  
         [0020]    [0020]FIG. 8 is a cross-sectional view of the adapter.  
     
    
     DETAILED DESCRIPTION  
       [0021]    [0021]FIG. 2 is an exploded perspective view of a pen needle magazine dispenser  10  according to the present invention. As shown in FIG. 2, pen needle magazine dispenser  10  includes a cover  20  and a container  30 . Container  30  includes a top  31  and a bottom  32  with top  31  being covered by a sterility barrier  150 . Container  30  also includes a flange  33  about its circumference that provides a stop for a bottom edge  21  of cover  20  and a detent  34  above flange  33  that interacts with a groove  22  within cover  20  to attach cover  20  on container  30 . FIG. 2 also shows an indicia  151  on sterility barrier  150  corresponding to a location of a pen needle assembly  100 .  
         [0022]    [0022]FIG. 3 is an exploded perspective view of pen needle magazine dispenser  10  shown in FIG. 2, and more clearly shows that container  30  includes a plurality of cavities  35 , with each cavity  35  dimensioned to receive a sleeve  40  containing a pen needle assembly  100 , described further below. Each pen needle assembly  100  is originally sealed in its respective sleeve  40  and cavity  35  by sterility barrier  150  that is attached to top  31  of container  30 . Sterility barrier  150  provides sterility for unused pen needle assemblies  100  contained in each sleeve  40  and a simple means for the user to identify whether the pen needle assembly in a particular sleeve has been used.  
         [0023]    Pen needle magazine dispenser  10  is initially loaded with a predetermined number of pen needle assemblies  100  in the sleeves in the plurality of cavities  35 , with all of the cavities  35  being sealed by sterility barrier  150  and having an indicia  151  thereon corresponding to each pen needle assembly  100 . Sterility barrier  150  is scored at the location of each sleeve  40  without, of course, affecting the integrity of the seal to allow for controlled breaking when adapter  50  on medication delivery pen  1  is pressed through label  150  when loading pen needle assembly  100  on adapter  50 . The controlled breaking of the scored area allows adapter  50  on medication delivery pen  1  to be inserted through label  150  to mate with pen needle assembly  100  within sleeve  40 .  
         [0024]    As described above, container  30  includes a plurality of cavities  35  that are dimensioned to receive pen needle assemblies  100 , as more clearly shown in FIGS. 3 and 4 and further described below. FIG. 3 shows a cross-sectional view of one of said plurality of cavities  35  and FIG. 4 more clearly shows adapter  50 . As shown in FIG. 3, each cavity  35  includes an open end  36  and a closed end  37 . Closed end  37  includes a plurality of anti-rotation ribs  38  that engage and are pressed fit together with a plurality of anti-rotation ribs  48  on the exterior of a sleeve  40 , described below. Open end  36  includes a groove  39  that receives a flange  49  on sleeve  40  to hold sleeve  40  within cavity  35 .  
         [0025]    Sleeve  40  includes a first and second open end  41  and  42  with flange  49  surrounding open end  41 . Open end  41  also includes a retention groove  43  for receiving a snap ring  55  on adapter  50 , described below. Sleeve  40  also includes a set of threads  44  therein that end at a shoulder  45  near second open end  42  having a smaller diameter than open end  41 . Second open end  42  is surrounded by a plurality of anti-rotation ribs  48  that mate with anti-rotation ribs  38  within cavity  35  to prevent rotation of sleeve  40  within cavity  35  and provide for both parts to be firmly pressed fit together. Of course, adhesives could also be added to prevent rotation and attach both parts together or other interacting shapes could be used within cavity  35  and in place of anti-rotation ribs  38  and  48 , for example, open end  42  could have a multi-surfaced shape like a hexagon.  
         [0026]    [0026]FIG. 3 also shows that pen needle assembly  100  includes a hub  102  having a plurality of keys  109  and a distal end  107  having a set of threads  101  thereon dimensioned to mate with the set of threads  44  within sleeve  40 . A needle cannula  103  is mounted within hub  102  and includes a distal point  104  and a proximal point  105 , wherein proximal point  105  extends from a proximal end  108  of hub  102  and distal point  104  extends out of distal end  107  on hub  102 . Each key  109  extends from proximal end  108  toward distal end  107  and terminates at an edge  106 .  
         [0027]    Each pen needle assembly  100  is threaded into sleeve  40  by interaction of threads  101  on pen needle assembly  100  and threads  44  within sleeve  40  until distal end  107  of needle assembly  100  is received by shoulder  45  and held in place by second open end  42 . This interaction prevents needle assembly  100  from accidentally separating from sleeve  40  until pen needle assembly  100  has been mounted on adapter  50 . Pen needle assembly  100  also includes an edge  110  located between threads  101  and distal end  107  that bottoms out on shoulder  45  to stop movement of pen needle assembly  100  within sleeve  40 . At the same time that flange  49  is received in groove  39  open end  42  makes contact with closed end  37  of cavity  35 . The assembled pen needle assembly  100  and sleeve  40  are inserted into a cavity  35  within container  30  until flange  49  snaps into groove  39  within cavity  35  and anti-rotation ribs  48  and  38  are properly mated together. After a plurality of pen needle assemblies  100  have been loaded into pen needle magazine dispenser  10 , sterility barrier  150  is attached to top  31  of container  30  using a heat seal or adhesive and cover  20  is snapped onto container  30 .  
         [0028]    [0028]FIG. 4 is an exploded perspective view of a partially assembled pen needle magazine dispenser  10  having sleeve  40  mounted in cavity  35 , showing pen needle assembly  100 , an adapter  50  and a medication delivery pen  1  exploded therefrom. Adapter  50  includes an open proximal end  51  having a set of threads  52  dimensioned to mate with threads  8  on distal end  6  of conventional medication delivery pen  1 . Adapter  50  also includes an opening  53  in its distal end  54 . After adapter  50  has been threaded onto distal end  6  of pen  1 , distal end  54  of adapter  50  is used to remove pen needle assembly  100  from sleeve  40  by inserting key  109  on proximal end  108  of needle assembly  100  into a key way  56  within adapter  50 . When key  109  of needle assembly  100  is inserted into key way  56  in adapter  50 , rotation of medication delivery pen  1  causes pen needle assembly  100  to rotate within sleeve  40  and move key  109  of needle assembly  100  along key way  56  into channel  57  in adapter  50 . As key  109  moves from key way  56  into channel  57 , edge  106  moves over a helical surface  58  so to lock key  109  in channel  57  and prevent pen needle assembly  100  from sliding out of adapter  50 . Helical surface  58  in interaction with edge  106  also aids in driving pen needle assembly  100  into adapter  50  to a predetermined position where surface  111  is in contact with distal end  54  of adapter  50  to firmly hold pen needle assembly  100  within adapter  50 .  
         [0029]    As shown in FIGS. 6 and 7, as pen  1  is rotated in direction A, shown in FIG. 5, and needle assembly  100  is driven into adapter  50 , proximal point  105  of pen needle assembly  100  pierces rubber septum  2  of a cartridge  3  in pen  1  to place needle cannula  103  in communication with medication contained within cartridge  3  in pen  1 . Helical surface  58  and key  109  also holds proximal point  105  within rubber septum  2  and needle assembly  100  within adapter  50  during the injection of medication from cartridge  3  in pen  1 . FIG. 6 is a cross-sectional view of sleeve  40  in pen needle magazine dispenser  10  prior to attaching pen needle assembly  100  onto adapter  50 . FIG. 7 is a cross-sectional view of sleeve  40  after pen needle assembly  100  has been attached to adapter  50 . FIG. 8 more clearly shows key way  56 , channel  57  and helical surface  58  within adapter  50 .  
         [0030]    After use, the used pen needle assembly  100  mounted on adapter  50  on medication delivery pen  1  is reinserted into sleeve  40  until detent  55  and retention groove  43  mate and the set of threads  101  on pen needle assembly  100  come into contact with the set of threads  44  within sleeve  40 . Medication delivery pen  1  is then rotated in the opposite direction B, shown in FIG. 5, to thread pen needle assembly  100  back into sleeve  40  and pen  1  is then pulled out of container  30  as pen needle assembly  100  is pulled out of adapter  50 .  
         [0031]    The use of sleeve  40  within container  30  not only provides an efficient mechanism to load a pen needle assembly  100  into container  30  but it also provides for ease of manufacturing, inspection of individual pen needle assemblies and improved quality control. In particular, if a damaged pen needle assembly  100  is found within sleeve  40 , the entire sleeve  40  and pen needle assembly  100  can be disposed of and replaced with a new assembly  100  and sleeve  40  without loss of the remainder of container  30  and the other pen needle assemblies  100 . It is also important to note that each sleeve  40  includes a flange  49  which provides for easy handling of sleeve  40  and pen needle assembly  100 , when moving a loaded sleeve  40  to a cavity  35  within container  30  for insertion. By providing flange  49  on each sleeve  40 , sleeve  40  can ride on conventional rails during the manufacturing operation. This is very important given the overall dimensions of the pen needle assembly  100 . The present invention provides a needle assembly  100  that is significantly smaller that conventional pen needle assemblies  90 . For example, needle assembly  100  of the present invention has been designed by the inventors so to have a reusable adapter  50  and an overall needle assembly diameter C, shown in FIG. 4, less than 0.150 inches, which is less than half the overall diameter of a conventional pen needle assembly  90 . This design provides a needle assembly that can be carried by the user in a much smaller container and can be more easily packaged with similar needle assemblies in a common container. In addition, the reduction in overall size also reduces the material needed to fabricate the needle assembly and the volume of waste caused by the disposal of such needle assemblies.  
         [0032]    While the invention has been described with respect to a preferred embodiment, it is apparent that various changes can be made without departing from the scope of the invention as defined by the appended claims. For example, adapter  50  can be integrally molded onto or permanently attached to distal end  6  of a medication delivery pen  1  rather than being a separate part.