Abstract:
A sharps container for (i) the safe storage and dispensing of unused pen needle assemblies and (ii) a safe means for receiving used pen needles and ejecting same into the container. The container comprises a housing within which is rotatably mounted a used pen needle receiving and ejecting means. Used pen needles are inserted into the receiving means. The receiving and ejecting means is rotated and, during the rotation, cam follower means connected to the ejecting means engages cam means within the housing to cause the ejection of the used pen needle into the housing. The housing also has a separate storage space for unused pen needle assemblies. Alternate structures provide for withdrawal of unused pen needle assemblies for dispensing. The dispensing can be done on a serial basis where the pen needle assemblies which are attached to a flexible tape for serial withdrawal from the housing through an exit opening. The dispensing can also be done on a bulk basis where a plurality of unused pen needle assemblies are transferred through the exit opening at the same time.

Description:
BACKGROUND AND FIELD OF THE INVENTION 
   This invention provides a multipurpose “sharps” container. A first function is the disposal of used pen needles (sometimes hereafter referred to as “PNs”) and specifically to a sharps container for used PNs which provides the safe (no-touch) sequential insertion of used PNs into the container for safe storage therein. The invention, importantly, also provides for safe, convenient transportation of a plurality of unused pen needle assemblies (PNAs) within the same sharps container (but hygienically isolated from the used PNs) and for dispensing said unused PNAs from the sharps container. Embodiments of the invention provide for “bulk” dispensing of unused PNAs. 
   Because of well known health issues, the safe disposal of syringes and other “sharps” has long been a high priority for medical related and other facilities. Prior art sharps containers are found, for example, in venues such as hospitals, medical clinics, and retail and other non-medical establishments. These containers are usually securely attached to some base means and have a lock means to permit controlled and safe removal of used “sharps.” 
   There are also prior art “portable” sharps containers for syringes, examples being U.S. Pat. Nos. 5,494,158 and 6,685,017, which show sharps containers which necessarily are large because of the elongated syringes. 
   Medical delivery pens (sometimes hereafter “MDPs”) have, more recently, become widely used instead of, or in addition to, syringes, e.g., by diabetics, who frequently inject themselves several times a day with accurately measured, adjustable, pre-selected amounts of insulin or other medication. Medical delivery pens include a reservoir of medication and a distal end adapted to be attached (usually by thread means) to a pen needle assembly (PNA). As is well known (see, for example  FIG. 1  of U.S. Pat. No. 5,545,145), the pen needle assembly has (within an outer, generally cylindrical shield 28) a generally cylindrical housing 26 within which is mounted an axially extending hollow needle 21, (i) the proximal end 24 of which punctures a seal in the distal end 16 of the medical delivery pen 10 (to allow the flow there-through of medication) when the delivery pen is screwed into the proximal end of the pen needle cylindrical housing 26, and (ii) the distal end 22 of which is for insertion into tissue of the person requiring the medication. The pen needle assemblies typically include a removable thin sterile seal covering the proximal (large diameter) end of the said outer shield and a removable tube-like shield covering the distal portion of the hollow needle. The assembled pen needle assembly is then factory sterilized. The user of a pen needle assembly removes the seal from the outer shield, screws the pen into the proximal end of the pen needle housing, removes the outer and tube-like shields, sets the medical delivery pen for the desired dose of medication, and then inserts the distal end of the pen needle into the target tissue following which the medical delivery pen is actuated to deliver the desired dose of medication through the hollow needle into said tissue. 
   Many diabetics routinely administer medication to themselves several times a day by injection of a pre-selected quantity(ies) of insulin (or substitute medication) in liquid form; the correct amount of medication can be determined from prior professional medical instruction or by use of convenient portable blood analysis kits which are small, compact and provide rapid indicators of the user&#39;s blood sugar level. The several daily injections are often done away from the diabetic&#39;s home or residence which has made the use of the portable, convenient medical delivery pens widespread. The aforesaid testing kits and the medical delivery pens are relatively small in size and can easily fit within a woman&#39;s purse or equivalent. A typical scenario for a diabetic at a restaurant for a meal is to first use the blood sugar testing kit to obtain an indicator of his or her blood sugar level. This information then facilitates programming or adjusting the medical delivery pen to deliver the desired quantity of medication. Then the pen with an attached PN (a PNA sans the outer protective shield) is used to inject the medication. These steps require a relatively short length of time and can be done with minimum loss of privacy. 
   Some users who require multiple daily injections of medications use, selectively, both medical syringes and medical delivery pens (MDPs). For example, a diabetic may use a medical syringe (with a pre-selected amount of medication) at the beginning of the day and then shift to MDPs for subsequent injections that day because of convenience for use outside of their residence and also some users feel less discomfort from a PN injection as compared to that from a syringe needle-type injection. 
   MDPs are also widely used by doctors, nurses and other professionals in their duties. Many individuals will request (sometimes insist) that an injection be done with a pen needle rather than a syringe. The aforementioned professionals are especially mindful of possible dangers from a needle stick and the possible unwanted “sticks” that occur. 
   In a perfect world, the user (both individual and professional) of a pen needle assembly would, after the first use of a pen needle, carefully detach the used PN from the MDP and safely dispose said PN. An approved disposal procedure is (i) insertion of the distal end of the needle into the tube-like shield (sometimes omitted) and thence the shielded PN cylindrical housing into the outer shield (thus returning to a PNA configuration), (ii) unscrewing the MDP from the proximal end of the pen needle cylindrical housing, and (iii) careful placement of the used PN (in a PNA configuration) into a safe sharps container. 
   Alas, the recommended procedure is not always followed. Used (and potentially dangerous) PNs or PNAs are routinely left in unsafe places where innocent third parties may unwittingly be “stuck.” Examples (frequently outrageous) of such unsafe places are purses, the pockets on the back of aircraft seats, private and public wastebaskets, garbage cans, dumpsters and empty milk containers or other improvised and unsafe containers. 
   Further, the above described disposal procedure requires that the user (or associate) handle or hold the PN while the pen is unscrewed therefrom; this creates the possibility of a potentially dangerous stick Also, if the user (or associate) tries to insert the PN into the outer shield to form a PNA, then additional handling is again required with the possibility of a “stick” 
   One prior art example of a container for unused and used pen needle assemblies is U.S. Pat. No. 5,545,145 which shows a tube containing a small number of unused pen needle assemblies arranged in axial alignment. This patent also teaches that, as unused assemblies are removed from one end of the tube, then a used assembly may be inserted into the tube from the other end. The tube is adapted to be attached to the side of a medical delivery pen. This arrangement has significant shortcomings. The capacity is quite limited and, potentially dangerous “sticks” could occur when a user (or associate) tries to insert a used PN (with or without the protective outer shield) into the used end of the tube. 
   SUMMARY OF THE INVENTION 
   The present invention provides (i) a totally “no-touch” means for a user of a PNA to safely transfer a used PN from a MDP into a unique container for safe storage therein without, as indicated, any touching of the used PN by the user, (ii) hygienically separate safe transportation and storage of unused PNAs within the same unique container and (iii) means for controlled dispensing of said unused PNAs via an exit opening in said container. Additionally certain embodiments of our invention provide for sharps containers which, in addition to the function of safe storage of used PNs, have means for safe dispensing of bulk quantities of unused PNAs; this is a function which has special applicability in clinics and the like where large numbers of unused PNAs are required for daily requirements. 
   This invention provides a sharps container for safe manual, sequential “feeding,” or disposal of used PNs into the container for safe storage therein. The container is a housing with an internal storage space sized to hold a plurality of used PNs. A used PN receiving and ejecting means is provided within the housing and includes (i) manually rotatable means connected to the housing for rotation about an axis, (ii) an ejector assembly connected to the manually rotatable means (to rotate therewith about the axis) and including a cam follower means, and (iii) cam means on the housing positioned to contact and actuate the cam follower means upon rotation of the manually rotatable means, the “actuation” of the cam follower means causing the “ejection” of the PN into the container for safe storage. 
   Importantly, our invention also provides a sharps container which is especially useful for an individual such as a diabetic who may require several daily doses of medication, which doses are required throughout the day (frequently at meal time) and thus may occur at the users residence but are often at other locations such as the user&#39;s place of work, at a restaurant, in an automobile or aircraft, etc. Thus, the container has a convenient supply of unused PNAs to be used as required as well as the aforementioned means for the safe disposal of used PNs. Several different arrangements are shown for the storage and dispensing of unused PNAs. The container conveniently can be relatively compact and sized to fit within a woman&#39;s purse or equivalent. Alternately, the container can be sized larger to facilitate the storage therein of a large number of unused PNAs and, further, can be structured to dispense unused PNAs either sequentially or in bulk. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
       FIG. 1  is a top, side isometric view of a preferred embodiment of a PN sharps container provided by the invention. 
       FIG. 2A  is a view of a plurality of PNAs connected to a flexible tape and coiled in an unused PNA storage compartment in the container of  FIG. 1  as viewed along section lines  2 — 2  thereof. 
       FIG. 2B  is a view similar to that of  FIG. 2A  (but for an alternate preferred embodiment of the invention) with a plurality of unused PNAs attached to a tape means but oriented 90 degrees from the orientation of the PNAs in  FIG. 2A . 
       FIG. 2C  is a cross-sectional view of  FIG. 2B  as viewed along section lines  2 C— 2 C thereof. 
       FIG. 3  is a plan view of the tape means  59  used with the PNAs depicted in  FIG. 2A . 
       FIG. 4  is a plan view of the tape means  69  used with the PNAs depicted in  FIG. 2B . 
       FIGS. 5 ,  6 , and  7  show, respectively, our invention with alternate means in the bottom portion of the housing means for the storage and dispensing of unused PNAs. 
       FIG. 5A  is a cross-sectional view of a bin means for dispensing unused PNAs as viewed along section lines  5 A— 5 A of  FIG. 5 . 
       FIG. 6A  is a cross-sectional view of a drawer means  80  for dispensing unused PNAs as viewed along section lines  6 A— 6 A of  FIG. 6 . 
       FIG. 7A  is a cross-sectional view of the unused PNA storage and dispensing means of the sharps container AA- 3 . 
   

   DETAILED DESCRIPTION OF THE INVENTION 
     FIG. 1  shows a sharps container AA having a means for the safe, i.e., “no direct human touching” storage of used pen needles. The container comprises a housing  10  having a first or bottom storage and dispensing portion  11  and a second or upper cover portion  12  which fit together as shown. The first portion  11  is, in turn, divided into two parallel oriented portions  11 A and  11 B by a partition  11 AA integral with portion  11  and positioned to facilitate (i) the safe storage of a plurality of used PNs and (ii) the safe storage and dispensing of unused PNAs as is shown in  FIG. 1 . 
   Cover portion  12  of the housing means  10  has a curved shape about a rotational axis RA. The top of the cover  12  has an opening  13  sized to permit the axial insertion therethrough of a used pen needle PN identified in the drawings by reference numeral  50   
     FIG. 1  also shows, in phantom, a medical delivery pen (MDP) which is representative of the well known types currently used and having at the distal end thereof male thread means for attachment to female threads in the proximal end of a pen needle  50 . It should be assumed that pen needle  50  shown in  FIG. 1  has already been used and the user desires to safely remove the used pen needle from the pen and thence place the used pen needle into safe storage means. The pen needle  50  has a cylindrical surface  51  with a pre-selected outer diameter. The cylindrical surface also has a plurality of longitudinally extending shallow grooves  54  which co-act with radially extending ribs of a used pen needle receiving and ejecting assembly  30  to hold the pen needle against rotation about its longitudinal axis when the user unscrews the MDP therefrom. Additional specific details of the used pen needle receiving and ejecting assembly  30  and its associated coacting apparatus are shown in our copending application filed on even date herewith and having Ser. No. 10/862,621; the disclosure of same is incorporated herein for reference. Set forth below is a summary of the details and functions of the used pen needle receiving and ejecting assembly. 
   A manually rotatable means comprising an external knob  14  with connected shafts  15 ′ and  15 ″ and a central collar  16  rotatably supported by bearing means in end walls of the housing cover  12  section for rotation, relative to the housing, about a rotational axis RA. The collar  16  has a central bore sized to receive and firmly hold the used pen needle receiving and ejector assembly  30  and additionally has means for attachment thereto of the inboard ends of shafts  15 ′ and  15 ″. Thus manual rotation of the knob  14  will rotate the ejector assembly  30  about the rotational axis RA. 
   The ejector assembly  30 , for this embodiment, is shown to comprise a first member or elongated tubular member having first and second ends. The total axial length of the elongated tubular member is pre-selected, regard being given to the dimensions of the cover section  12 , so that the tubular member may be rotated about the rotational axis without contacting the inside surface  12  of the housing but yet have the used pen needle receiving end thereof sufficiently adjacent to the opening  13  to provide the used pen needle receiving function. 
   An elongated ejector means has a pre-selected axial length and a cylindrical shape sized to slidably fit within the elongated tubular member for relative axial movement therewith; a rounded cam follower end  40 C of the ejector means being shown in  FIG. 1 . It is important to note that end  40 C of the ejector means normally, i.e. initially, extends a pre-selected distance beyond one end of the tubular member as is shown in  FIG. 5A . The terms “normally” and “initially” cover the case when the cam follower end  40 C is not in contact with its co-acting cam means. The co-acting cam means is positioned within and fixed to the cover section  12  and may, in fact, be the inside curved surface of cover section  12 . Additional details regarding the cam follower-cam function are available in our above mentioned co-pending application. 
   Thus, rotation of the knob  14  (and thus the entire used pen needle receiving and ejecting means  30 ) causes contact by the cam follower  40 C with the aforesaid cam means to force the ejector means axially within the elongated tubular means to push, i.e. eject a used pen needle out from its received position into the used pen needle storage portion  11 A. 
   It will be understood that the pen user does not have to touch the used pen needle either to (i) remove the used pen needle from the pen, or (ii) dispose the used pen needle into a safe storage means. 
   The unused PNA storage and dispensing portion  11 B of the housing is shown in several, alternate configurations. The first is shown in  FIG. 2A . One of the side walls  11 ′ of storage section  11 B includes an exit opening  11 B′ and an internal side wall  11 BB to permit withdrawal of unused PNAs  60 ,  61 ,  62  . . .  60 N attached to a flexible tape means  59  by being positioned in serial, spaced apart holes  59 ′ in the tape as is shown in  FIG. 3 .  FIG. 2A  shows clearly the PNAs within the storage space, coiled around side wall  11 BB, and exiting at opening  11 B′.  FIG. 1  also shows the tape  59  with connected PNAs  60  et seq. available, upon demand, to the MDP user at exit opening  11 B′; the user of the unused PNAs pulls on the end of the tape  59  to receive the desired number of unused PNAs. 
   An alternate unused PNA storage and dispensing configuration  11 B is shown in  FIGS. 2B and 2C . Again, a side wall  11 ′ has an exit opening  11 B′. Within the storage and dispensing portion  11 B are (i) a pair of angled interior walls CC′ positioned in the corners as shown and (ii) a spiraled guide means D 1 ) having a first end DD′ attached to a side  11  of the portion and a second end DD″ generally centrally positioned in the portion. A plurality of unused PNAs ( 70 ,  71 ,  72 ,  73  . . .  70 N) are depicted connected in a serial, spaced-apart configuration to a tape  69 . The tape  69  with attached PNAs is configured in a coil and is shown following the spiral guide means DD. The PNAs may be attached to the tape  69  by suitable means such as an adhesive, the cylindrical sides of the PNAs being the zone of attachment to the tape. The spiral guide means DD thus facilitates the loading and dispensing of unused PNAs into and out of the storage space. 
   Other configurations for the storage and dispensing the unused PNAs also may be used. The configuration depicted in  FIGS. 2B and 2C  has an advantage of an increased number of PNAs being storable in a given container footprint as compared to that of  FIG. 2A . 
   It will be noted that the configurations depicted in  FIGS. 1–2C  are especially useful in the sequential dispensing of unused PNAs, the user pulling out only the next available PNA. However, the user could pull out several PNAs if that were desired. 
   The following embodiments of our invention facilitate the simultaneous safe dispensing of a plurality of unused PNAs from the sharps container; for some applications such as use in a clinic, this function can be very desirable. 
     FIG. 5  shows a sharps container AA- 1  which is very similar to container AA shown in  FIG. 1 ; it has the same used PN receiving, ejecting and storage means as container AA. However, the unused PNA storage and dispensing means is different; it is configured to facilitate the dispensing of more than one unused PNA at the same time, i.e., a means to provide unused PNAs in bulk quantities. 
   Thus container AA- 1  has a housing means with partition  11 AA separating used PN storage portion  11 A from unused PNA storage and dispensing portion  11 B. An exit opening  11 S at the left side of portion  11 B (as viewed in  FIG. 5 ) is provided, within which is a bin-like member  70  is rotatably positioned. Bin member  70  has (i) two angularly-displaced-apart longitudinally extending surfaces  70   a  and  70   b , joined at  70 AA to form a V-shaped cross section as is shown in  FIG. 5A  and (ii) end surfaces means  70   c  and  70   d  to form a unitary pocket means sized to hold a plurality of unused PNAs. Bin member  70  is supported by bearing means  11 P so that it may be manually rotated (by use of a tab  70 ′) between an open or dispensing position as shown in  FIG. 5  and a closed position where surface  70   a  is coplanar with the side  11  of the housing. When bin member  70  is in the closed position, additional unused PNAs may be transferred into said pocket as can be seen in  FIG. 5A . End surface means  70   c  and  70   d  have stop means  70   c ′ and  70   d ′ to limit the outward rotation of the bin member  70 . 
     FIG. 6  depicts another sharps container AA- 2  having the same used PN receiving, ejecting and storage means as container AA of  FIG. 1  but providing an alternate, multiple unused PNA dispensing apparatus. Thus container AA- 2  has partition  11 AA for defining used PN storage portion  11 A and unused PNA storage and dispensing portion  11 B. An exit opening  11 S′ at the left side of portion  11 B (as viewed in  FIG. 6 ) is provided and is sized to admit the transverse motion of a drawer  80  in and out of the housing to an unused PNA dispensing position shown in  FIG. 6 . The drawer has a bottom  80   a , two sides  80   b  and  80   c , a front  80   d  (with transversely extending pull tab  80 ′), and back ramp-like means  80   e . Stop means  80   c ′ and  80   d ′ on the sides of the drawer limit the outward travel thereof. In operation, the drawer, holding unused PNAs  81 ,  82 ,  83  and  84 , may be manually pulled out (by the user using tab  80 ′) from portion  11 B to the position shown in  FIG. 6  to allow the user to remove said unused PNAs. Manual closing of the drawer  80  results in the front  80   d  being coplanar with the side  11  of the housing and, importantly, the ramp means  80   e , as the drawer is closing, coacts with unused PNAs in portion  11   b  to transfer some into the drawer for additional dispensing to a user as is clearly shown in  FIG. 6A . 
   Another embodiment of our invention is the sharps container AA- 3  depicted in  FIGS. 7 and 7A  which also uses the same used PN receiving, ejecting and storage means as container AA. Partition  11 AA again defines the used PN storage portion  11 A; however the unused PNA portion is divided into two sub-portions  11 B- 1  and  11 B- 2  defined by a partition  11 FF integral with side  11  of the housing and extending parallel to the bottom  11 EE of the housing (best shown in  FIG. 7A ). The vertical height of the sub-portions is pre-selected to allow for the storage of unused PNAs arranged with the proximal ends thereof abutting the bottom members  91  and  101  of a pair of tray means  90  and  100  respectively. Tray  90  also has a front  92  sized to match the exit opening  115 ″ between members  11 EE and  11 FF. Tray  100  also has a front  102  sized to match the exit opening  115 ′″ between members  11 A and  11 FF. Fronts  92  and  102  have engagement means  92 ′ and  102 ′ respectively for facilitating the manual withdrawal of the trays from the housing means. 
   A large number of unused PNAs are positioned on each of trays  90  and  100 . Tray  90  has PNAs  95 ,  96  . . .  90 N and tray  100  has PNAs  105 ,  106  . . .  100 N; the PNAs, as indicated, are preferably oriented with the proximal ends abutting their respective trays. The PNAs may be secured by a suitable adhesive means to the trays. This orientation of the PNAs permits a maximization of the number of unused PNAs for a given size container. 
   While we have shown our preferred embodiments of the invention, it will be understood that variations may be made without departing from the inventive concept. Accordingly, the invention is to be limited only by the scope of the following claims.