WO2005120610A2

WO2005120610A2 - Sharps container for used pen needle assemblies

Info

Publication number: WO2005120610A2
Application number: PCT/US2005/020007
Authority: WO
Inventors: Roger W. Jensen; Thomas E. Erickson; James J. Erickson; Tomothy A. Bachman
Original assignee: Ultimed, Inc.
Priority date: 2004-06-07
Filing date: 2005-06-07
Publication date: 2005-12-22
Also published as: WO2005120610A3

Abstract

An illustrative sharps container for (i) safe transportation and dispensing of a large number of unused pen needle assemblies, and (ii) safe storage of used pen needle assemblies. The sharps container for pen needle assemblies may include a receptacle and a movable means. In some cases, the illustrative container may also include a cover member. The manually movable means may be rotatably positioned on the cover and may have portions collectively forming a cup-like means for receiving a used pen needle assembly when the movable means may be in an open position. When the movable means may be in a closed position, the used pen needle assembly may be transferred by gravity to the bottom of the receptacle. The unused pen needle assemblies may be connected to a flexible tape and may be removed from a storage receptacle via an opening in the receptacle.

Description

SHARPS CONTAINER FOR USED PEN NEEDLE ASSEMBLIES BACKGROUND AND FIELD OF THE INVENTION [0001] This invention relates specifically to multi-functional "sharps" containers which provide (i) safe transportation of the container and a large number, i.e., a "bulk" quantity of unused pen needle assemblies (sometimes hereafter referred to as "PNAs") therein, (ii) the safe sequential dispensing of the aforesaid unused PNAs from the container and (iii) the safe sequential feeding or insertion of used PNAs into the container for safe storage therein. Because of well known health issues, the safe disposal of medical/other syringes has long been a high priority for the related professions and industries. The prior art containers for such syringes are commonly termed "sharps containers" and many configuration of these are found in public venues such as hospitals, medical clinics, and retail 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." [0002] There are also prior art "portable" sharps containers for syringes. Examples of prior art portable "sharps" containers for syringes are U.S. Patents 5,494,158 and 6,685,017; these sharps containers necessarily are large because of the elongated length of the syringes. [0003] Medical delivery pens have, more recently, become widely used, e.g., by diabetics, who frequently inject themselves several times a day with accurately measured 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. As is well known, the pen needle assembly has (within an outer, generally cylindrical shield) a generally cylindrical housing within which is mounted an axially extending hollow needle, (i) the proximal end of which punctures a seal in the distal end of the medical delivery pen (to allow the flow there-through of medication) when the delivery pen is screwed into the proximal end of the pen needle housing, and (ii) the distal end 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.

[0004] Many diabetics routinely administer medication to themselves several times a day by injection of a pre-selected quantity of insulin (or medical substitute medication) in liquid form; the correct amount of medication can be determined from prior professional medical instruction or by use of convenient blood analysis kits which are small, compact and provide rapid indicators of the user's blood sugar level. The several daily injections are, at least in part, done away from the diabetic's home or residence which has made the use of 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's purse or equivalent. A typical scenario for a diabetic at a restaurant is, before a meal, to 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 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.

[0005] In a perfect world, the user of a pen needle assembly would, after the first use of a pen needle assembly, carefully detach the used pen needle assembly from the medical delivery pen and safely dispose said assembly. The approved procedure is (i) insertion of the distal end of the needle into the tube-like shield and thence the shielded needle and cylindrical housing into the outer shield, (ii) unscrewing of the medical delivery pen from the proximal end of the pen needle housing, and (iii) placement of the used pen needle assembly into a safe sharps container. Alas, the recommended procedure is not always followed. Used (and potentially dangerous) pen needles, with or without outer shields, are routinely left in unsafe places where third parties may unwittingly be "stuck." Examples of such unsafe places are purses, the seat pockets on the back of aircraft seats, private and public wastebaskets, garbage cans, dumpsters and empty milk bottles or other unsafe containers.

[0006] One prior art example of a container for used pen needle assemblies is U.S. 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 certain shortcomings. The capacity is quite limited and, potentially dangerous "sticks" could occur when a user tries to insert a used assembly (without the protective outer shield) into the used end of the tube.

[0007] Other prior art sharps containers may be used for disposal of used pen needle assemblies; however they are typically far too large and bulky and have other disadvantages. SUMMARY OF THE INVENTION

[0008] This' invention covers multi-functional "sharps" containers which provide (i) safe transportation of the container and a large number (bulk quantity) of unused PNAs therein, (ii) the safe sequential dispensing of the unused PNAs from the container and (iii) the safe sequential feeding or insertion of used PNAs into the container for safe storage therein; the invention facilitating the ultimate safe disposal of the used PNAs.

[0009] The present invention provides a safe, space efficient sharps container for providing the aforesaid functions. The invention may provide a 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 as well as at other locations such as the user's place of work, at a restaurant, in an automobile or aircraft, etc. The container which on the one hand may contain "bulk" quantities of unused PNAs and provide safe storage for similar quantities of used PNAs, on the other hand, may be relatively compact and sized to fit within a woman's purse or equivalent.

[0010] In broad terms, the present invention may provide a container comprising a receptacle, and a movable means which may be rotated from a "closed" position to an "open" position. In the open position the movable means may receive a used pen needle assembly. Then manual rotation of the movable means to the closed position may facilitate the discharge of the used pen needle assembly into the receptacle. The receptacle may be sized to hold a plurality of used pen needle assemblies (with or without the outer shields). The receptacle may be a cup-like vessel which, although of a size to hold a large number of used pen needle assemblies, may at the same time be "small" and/or "thin" enough to be conveniently portable for travel with the user.

[0011] In some cases, the receptacle may also include internal means for segregating unused PNAs from used PNAs; such internal means may be a fixed partition or may be a movable dividing tray means.

[0012] Under some circumstances, the container may include a cover member. The cover member may be sized to fully cover the at least a portion of the receptacle and may have a top surface and may have a side surface(s).

[0013] The movable means, in one embodiment, may be a rotatable hatch means. The rotatable hatch means may be adapted to be mounted in an opening in the top of the cover for rotation between a closed position and an open position. The hatch means may include a top portion, a bottom portion, and a pair of axially spaced-apart side portions which collectively define a cup-like receiving means for only a single PNA when the hatch means is in the open position. Other means for disposing of or discharging used PNAs into the receptacle are also shown.

[0014] The cover member may include a baffle means which, in the preferred embodiment, has a curved cross-section. The hatch means may be rotatably mounted on the cover. The side portions thereof have curved edges matched to mate with the curved surface of the baffle means when the hatch means is in the open position; in this position the bottom portion of the hatch means and the said side portions effectively block or prevent any "removal" from the receptacle of a previously disposed used pen needle assembly.

[0015] The receptacle may also include an opening sized to facilitate sequential withdrawal therethrough of unused PNAs. Several alternatives are shown for storing the PNAs and the sequential dispensing of same through an exit opening in the receptacle.

[0016] The use of the container by the user may be easy. For example, when using the embodiment comprising the above described hatch means, the hatch means may be rotated to the open position, the used pen needle assembly may be placed or dropped into the hatch means, and then the hatch means may be rotated to the closed position. When the hatch means is closed, then the used pen needle assembly falls into the receptacle. Again, the used PNAs will be stored (hygienically separated from the unused PNAs) in either a space defined in part by a fixed partition or by a movable dividing tray means. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 is an isometric view of a preferred embodiment of a sharps container provided by the invention.

[0018] Figure 2 is a cross-sectional view of the receptacle and attached cover member but excluding the hatch means.

[0019] Figure 3 is a right side view of the hatch means.

[0020] Figure 4 is a cross-sectional view of the receptacle and cover member as viewed along section lines 4-4 of Figure 2.

[0021] Figure 5 is a view of the hatch means as viewed along section lines 5-5 of Figure 3.

[0022] Figure 6 is a cross-sectional view of the assembled receptacle, cover member and hatch means showing the hatch means in the closed position and (in phantom) in the open position.

[0023] Figure 7 shows another embodiment of the invention, a sharps container having a variation in the shapes of the receptacle and cover member.

[0024] Figure 8 is a side, cross-sectional view of a first embodiment of a sharps container provided by the invention.

[0025] Figure 8A is a side, cross-sectional view of the container of Figure 8 with a substantial number of unused pen needle assemblies having been removed from the receptacle accompanied by the dividing tray means having moved longitudinally down toward the bottom of the receptacle.

[0026] Figure 8B is a plan view of a section of a flexible tape 60 used in the unused pen needle assembly dispensing means shown in Figures 8 and 9.

[0027] Figure 9 is a side, cross-sectional view of another embodiment of the invention.

[0028] Figure 10 is a side, cross-sectional view of another embodiment of the invention. [0029] Figure 11 is a plan view of a section of flexible tape means 70 used to hold a plurality of pen needle assemblies as shown in the containers depicted in Figures 10 and 12. Figure 12 is an isometric view (partly in section) of another embodiment of a sharps container provided by the invention. DETAILED DESCRIPTION OF THE INVENTION

[0030] Figures 1 and 6 show a fully assembled illustrative container AA for storing a large number of pen needle assemblies. Container AA may comprises a receptacle 10 and hatch means 30. In some cases, the illustrative container AA may include a cover member 20, however, this is not required.

[0031] The receptacle 10 is shown to be square-like in cross-section with sides 11, 12, 13 and 14 with a bottom 15. However, it will be understood that other cross- sections may be used such as the round cross-section of the container shown in Figure 7. The receptacle may be essentially an open cup with a top edge surface 10'. The receptacle may be sized to hold up to a maximum preselected number of used pen needle assemblies.

[0032] The cover member 20 may have a top portion and four sides: 22, 23, 24, and 25. As is clearly shown, the cover member 20 may be sized to fit (snuggly) over the top of the receptacle 10. Latching or locking means may be used to lock the cover member to the receptacle; such means are shown in Figures 4 and 6 where the receptacle 10 has a radially extending shoulder 17 and'the cover member has inwardly extending latch means 27 and shoulder means 26.

[0033] The cover member 20 has a centrally located, square-shaped opening with sides 21a, 21b, 21c and 21d (see Figures 1, 2 and 4). Sides 21b and 21d have short, downward extending shoulders 21b' and 2 Id' as is best shown in Figure 4. Side 21a has a rounded "cross-section" shape as is shown in Figure 2.

[0034] The hatch means 30 may be positioned in the above described square-shaped opening and may be supported by the cover member 20 for rotation between a closed position shown in Figure 6 and an open position shown in Figure 1. In some cases, the illustrative hatch means 30 may be manually movable. The hatch means 30 may comprise a square-shaped top portion 31 having a first end 31a from which depends an offset lip 31', the outboard edge 31" of which facilitates manual rotation of the hatch relative to the cover member 20. A pivot means may be provided at the opposite end or side of the top portion 31 ; the pivot means are stub shaft elements 32 (see Figure 5) which may be fitted into bores 32' at the ends of shoulders 21b' and 21d'(see Figure 2). The hatch means 30 may also includes a bottom portion 33 which, in the preferred embodiment, has a curved shape as is best shown in Figures 3 and 6. The bottom portion 33 may be integral with the pivot end of top portion 31 and the opposite end is identified by reference numeral 33'. The bottom portion may have a lateral width substantially equal to that of the top portion. A pair of similar axially spaced-apart side portions 34 and 35 have a somewhat triangular shape (see Figure 3 for 34) and are integral with top portion 31 and bottom portion 33. Further, the side portions may have pre-selected curved edges 34' and 35'. The edges 34' and 35' in turn may have notches 34a/34b and 35 a/35b respectively for holding the hatch means in open and closed positions. The top, bottom and side portions of the hatch means may collectively define a cup-like receiving means for receiving used pen needle assemblies as well as unprotected pen needles.

[0035] The illustrative container AA may further includes a downwardly extending baffle means 21AA integral with the top surface 21 of cover member 20. Baffle means 21AA may be an elongated, curved member attached at its top end (as shown in Figure 2) to the underside of round edge or surface 21a of the opening in cover 20. The baffle means may have approximately the same lateral width as that of the bottom portion 33 of the hatch means (see Figure 1) and may have a bottom, horizontally disposed edge 21AA' (see Figures 2 and 6).

[0036] As is best illustrated in Figure 6, the curved edges 34' and 35' of the sides 34 and 35 of the hatch means 30 may be sized to be in close, but not touching, contact with the curved baffle means 21AA.

[0037] The illustrative sharps container BB shown in Figure 7 may be very similar to that of Figures 1 - 6, except the receptacle and cover, as illustrated, may have a round cross-section. It may comprise a receptacle 110, a cover member 120 with side means 120A and a hatch means 30 of the type above described. The receptacle 110 may have a shoulder 117 for locking the cover member thereto. A representative PNA is shown in transit from the hatch means to the receptacle. A first end P' of the needle assembly may be adapted to be received by the medical delivery pen as aforesaid; a second end P" may be protected by an outer shield S. [0038] The user or pen needle assemblies (PNAs) can conveniently safely store used PNAs in the container AA. Figure 6 shows a used PNA' ready to be stored. The hatch means 30 may be opened to the open position shown in Figure 1 (also shown by dotted lines in Figure 6). The hatch means may be held in said open position by the coaction between the notches 34a and 35a and the rounded surface 21a of the cover.

[0039] The said used PNA' may then rest on the bottom portion 33 of the hatch means as is depicted (as PNA") in Figures 1 and 6. The hatch means may then be rotated to the closed position shown in Figure 6 and PNA" may be released by the bottom portion 33 to slide, under the force of gravity, through the space between the edges 33' and 21AA' to the bottom of the receptacle 10 as PNA'".

[0040] Of course, some users might not, for various reasons, re-insert the pen needle into its protective outer shield after the pen needle is disconnected from the medical delivery pen; for this scenario the container provided by this invention can be used to safely store the pen needles. Such unprotected pen needles may be placed onto the bottom portion of the hatch means and transferred into the receptacle 10.

[0041] An important feature of this invention may be that the hatch means 30 permits only the transit of PNAs into the receptacle, but does not permit a used PNA or an unprotected pen needle to be removed from the receptacle, via the hatch means, once the same are in the receptacle. This may be because the bottom portion 33 of the hatch means serves as a barrier when the hatch means may be in the open position.

[0042] When the user of the sharps container wants to safely and hygienically dispose of used PNAs, the preferred procedure is to transfer the entire container to an approved disposal means or site without attempting to remove the cover from the receptacle.

[0043] Further, while the movable means which may be rotated between open and closed positions has been illustrated and described as hatch means 30, it will be under stood that many other rotatable configurations are covered.

[0044] The illustrative sharps container AAA shown in Figure 8 is depicted with a longitudinal axis LA and first and second transverse axes TA and TA', the three axes being mutually perpendicular. The container AAA may include a receptacle 210, cover means 220, a dividing tray means 240 within the receptacle, and a operable means 230 in the cover means 220 for facilitating the sequential longitudinal disposal of individual used pen needle assemblies into the tray means 240. The receptacle 210 may have a cup-like shape (with a pre-selected round or polygonal cross-section) with a side 211, an open top 212 and a bottom surface 214. An exit opening 216 may be provided in side 211 near the bottom surface 214 and may be sized by edges 216' and 216" to facilitate sequential transverse withdrawal therethrough of unused pen needle assemblies 250 stored beneath the bottom 242 of dividing tray means 240 in the bottom portion of the receptacle 210. Edge 216' may be at the end of an upturned portion 214' of the bottom surface 214. The plurality of PNAs 250 are shown in Figure 8 oriented on the cylindrical side of the outer shield, spaced-apart a preselected amount, and attached to a flexible tape means 260 (see also Figure 8B) by suitable means such as an adhesive. The plurality of PNAs 250 are configured into a coil as is clearly shown in Figure 8. The PNA closest to the exit opening 216 is identified by reference 251; the next four, in spaced-apart sequence, by references 252, 253, 254, and 255. The last PNA 250-N is at the end of the tape means 260 at the center of the coiled assembly of PNAs. The depicted attachment of the individual PNAs to the flexible tape 260 is space efficient and facilitates the storage of a large number of PNAs in a given space.

[0045] The operable means 230 in the cover means 220 is similar to the hatch means 30, or movable means, as described previously. Briefly, the cover means 230 may be a cup-like device rotatably mounted on cover means 220 for rotation about a transverse axis between a closed position (solid in Figure 8) and an open position (dashed lines in Figure 8). When the cup is in the open position, then used PNAs and pen needles PNs may be sequentially placed within the cup. The cup may then be rotated to its closed position which then may open up a pre-determined space or open gap between the bottom edge 233' of the bottom 233 of the cup and the bottom edge 221 A A' of a baffle means 221AA; the aforesaid used PNAs and PNs may pass through said space or gap to be collected by the dividing tray means 240.

[0046] Figure 8A shows the same sharps container AAA as Figure 8 but with many of the unused PNAs already dispensed by being pulled out of exit opening 216 on the flexible tape 260. As the unused PNAs may be removed from the receptacle 210, the dividing tray means 240 may descend longitudinally as space becomes available.

[0047] Figure 9 shows an alternate illustrative sharps container BB comprising a receptacle 310, a cover means 320, an used PNA and/or PN disposal means 330, a partition 329 integral with cover means 320 to define a used PNA and/or PN and/or PN outer cylindrical shield storage space, and a coiled plurality 350 of unused PNAs: 351, 352 350N may be attached at the proximal ends thereof to a flexible tape means 260 within the receptacle 310. An exit opening 316 in side 311 of the receptacle may facilitate the sequential series removal of the PNAs attached to the tape. The disposal means 330 is the same as the disposal means 330 of the sharps container DD shown in Figure 12 may comprise a plurality of flexible tabs 331 arranged in a generally circular configuration, being attached at the outer or radial extent to the cover and may be longitudinally displaceable at their tips so as to facilitate the longitudinal passage therethrough of used PNAs and/or PNs and/or PN outer cylindrical shields.

[0048] Figure 10 shows another alternate illustrative sharps container CC comprising a receptacle 410, a cover means 420 including a bottom positioned partition 429 (to define a used PNA and/or PN and/or PN outer cylindrical shield storage space), an used PNA and/or PN and/or PN outer cylindrical shield disposal means 330 (above described), and a coiled plurality 450 of unused PNAs 451 , 452, 453 450N attached to a flexible tape means 270 by being inserted in spaced-apart apertures or openings 271 in the tape means 270 as is shown in Figure 11. Thus the openings 271 may be sized to snuggly receive the outer diameter of the safety shield of a PNA. The receptacle 410 may have sides 411, a bottom 414, and an exit opening 416 near the top of the receptacle. The coil of PNAs are shown oriented so that the first PNA 451 may be adjacent the exit opening 416 and may be held in "ready" position by the end 270a of the flexible tape means 270 being detachably connected to the side 411 of the receptacle. Thus this embodiment of the invention may also provide a sharps container (i) for the safe transportation and safe sequential dispensing of a large number of unused pen needle assemblies, and (ii) the safe sequential feeding of used PNAs and/or PNs into the above described used PNA and/or PN storage space.

[0049] The sharps container DD shown in Figure 12 is a modification of the apparatus shown in Figure 10 comprising a receptacle 510, a cover means 520 including a side 522 and a bottom-positioned partition 529 (to define a used PNA and/or PN storage space), the above described used PNA and/or PN disposal means 330, and three transversely spaced-apart coils of PNAs I, II and III, each having unused PNAs connected to flexible tapes 270 similar to the arrangement shown in Figure 10. Tape ends 270' are shown for coils I and II and may be detachably connected to the side 511 of the receptacle. The coils may be separated by panels 518. The sides 522 of the cover 520 may lock onto the top 512 of the receptacle.

[0050] When the user of the disclosed embodiments of sharps containers wants to safely and hygienically dispose of used PNAs and/or PNs, one illustrative procedure may be to transfer the entire container to an approved disposal means or site without attempting to remove the cover from the receptacle. As described, the covers may have locking means which may be intended to prevent or at least impede access to the used sharps or containers therefore.

[0051] While a few illustrative embodiments of the invention has been shown, it will be understood that variations may be made without departing from the inventive concept. It should, as an example, be understood that the term "pen needle assembly" (PNA) be interpreted to cover (i) a complete assembly including the above described cylindrical housing and axially extending needle with associated needle shield and outer shield, as well as (ii) the aforesaid assembly sans one or both shields and/or the shields. Accordingly, the invention is to be limited only by the scope of the following claims.

Claims

In the claims: 1. A container for storing a plurality of pen needle assemblies, the container comprising: a receptacle sized to hold a plurality of pen needle assemblies; and a disposal means situated on said receptacle for facilitating the disposal of pen needle assemblies into said receptacle.

2. The container of claim 1 wherein the pen needle assemblies are used.

3. The container of claim 2 wherein the disposal means is a manually movable pen needle assembly disposal means.

4. The container of claim 1 further comprising a cover member sized to cover said receptacle, wherein said disposal means is mounted on said cover member.

5. The container of claim 2 wherein the disposal means is rotatably mounted on said cover member.

6. The container of claim 5 wherein said disposal means includes a first position for receiving a pen needle assembly and a second position for discharging a pen needle assembly into said receptacle.

7. The container of claim 6 wherein said first position receives only a single pen needle assembly and the second position discharges a single pen needle assembly.

8. The container of claim 7 including means for controlled holding of said disposal means in said first position.

9. The container of claim 8 including means for controlled holding of said disposal means in said second position.

10. The container of claim 1 wherein the disposal means includes a hatch means.

11. The container of claim 10 wherein the hatch means comprises : a top portion having a first edge and a pivot means spaced from said first edge, said pivot means being connected to said receptacle and defining a rotational axis for rotation of said hatch means relative to said receptacle; a bottom portion integral with said top portion and extending at a pre-selected angle relative to said top portion; and axially spaced-apart side portions connected to said top and bottom portions, said top, bottom and side portions collectively defining a cup-like receiving means; wherein said hatch means being rotatable between a closed position whereat said top portion is substantially contiguous with said receptacle and an open position whereat said top portion is displaced with respect to said receptacle.

12. The container of claim 11 further comprising a cover member sized to cover said receptacle, wherein the cover member includes a top surface, and wherein said hatch means is positioned in an opening in said top surface of said cover member.

13. The container of claim 12 further comprising baffle means to substantially inhibit the removal of previously disposed pen needle assemblies from said receptacle.

14. The container of claim 13 wherein said baffle means are integral with said top surface of said cover member and extending at a pre-selected angle thereto, said baffle means having surface means substantially matching a pre-selected portion of said hatch means, and said baffle means being oriented and positioned with respect to said hatch means so, when said hatch means is rotated about said rotational axis to said first position, said baffle means and said pre-selected portion of said hatch means are in close proximity.

15. The container of claim 12 wherein said baffle means (i) is shaped with a pre-selected curved cross-section and (ii) terminates with a bottom baffle edge.

16. The container of claim 15 wherein said axially spaced-apart sides of said hatch means have similar outwardly extending edges, said edges being curved to be in close proximity with said pre-selected curved cross-section of said baffle means when said hatch means is in said open position.

17. The container of claim 16 wherein said bottom portion of said hatch means is curved terminating with an edge defining a portion of said cup-like receiving means, said bottom baffle edge of said baffle means and said edge of said bottom portion of said hatch means being spaced apart a pre-selected distance when said hatch means is in said closed position, said pre-selected distance allowing the passage there-through of an used pen needle assembly.

18. The container of claim 12 further characterized by said hatch means and said baffle means being sized so, when said hatch means is in said closed position, a pre-selected opening is defined between said hatch means and said baffle means to permit the free passage there-through of a used pen needle assembly.

19. The container of claim 17 wherein, when said hatch means is in said open position, said edge of said bottom portion of said hatch means is proximate said curved cross-section of said baffle means to thereby (i) facilitate a temporary resting area of an used pen needle on said bottom portion of said hatch means, and (ii) prevent removal of an used pen needle from said receptacle through said cover member.

20. The container of claim 12 further characterized by said including means connected to said first edge of said top portion of said hatch means to facilitate said manual rotation of said hatch means between said open and closed positions.

21. The container of claim 1 wherein the receptacle sized to hold a plurality of pen needle assemblies includes a first portion and a second portion.

22. The container of claim 21 wherein the first portion of the receptacle facilitates the holding of used pen needle assemblies.

23. The container of claim 22 wherein the disposal means deposits used pen needle assemblies in the first portion of the receptacle.

24. The container of claim 23 wherein the second portion of the receptacle facilitates the holding of unused pen needle assemblies.

25. The container of claim 24 wherein the receptacle includes an opening to the second portion for the withdrawal of unused pen needle assemblies.

26. The container of claim 25 wherein the first portion of the receptacle is the top portion and the second portion of the receptacle is the bottom portion.

27. The container of claim 24 further comprising a dividing tray means positioned within said receptacle.

28. The container of claim 25 wherein the disposal of used pen needle assemblies into said receptacle is onto said dividing tray means.

29. The container of claim 27 wherein the dividing tray forms a partition between the first portion of the receptacle and the second portion of the receptacle, wherein the dividing tray is moveable between the first portion of the receptacle and the second portion of the receptacle.

30. The container of claim 25 including a plurality of pen needle assemblies positioned within said receptacle and connected to a coiled, flexible tape means.

31. The container of claim 30 wherein said pen needle assemblies connected to said coiled flexible tape are oriented about an axis of said container.

32. The container of claim 31 wherein said pen needle assembles connected to said flexible tape are coiled about one of said transverse axes.

33. The container of claim 30 wherein said outer cylindrical shields of said pen needle assemblies are connected to said flexible tape.

34. The container of claim 30 wherein said removable seals of said pen needle assemblies are connected to said flexible tape.

35. The container of claim 30 wherein said tape has a plurality of spaced- apart apertures sized to receive said outer, cylindrical shields of said pen needle assemblies.

36. The container of claim 27 wherein said dividing tray means (i) has a bottom surface and is sized to fit in close but unrestricted relationship with said receptacle and (ii) is adapted to be rested and supported with said bottom surface on top of a plurality of unused pen needle assemblies in said receptacle, and thence incrementally moving longitudinally downward toward the bottom of said receptacle as unused pen needle assemblies are removed from said receptacle through said exit opening thereof.

37. The container of claim 24 further comprising partition means within said receptacle dividing said receptacle into a first portion for storage of used pen needle assemblies and a second portion for storage of unused pen needle assemblies.

38. The container of claim 30 including a plurality of said coiled, flexible tape means each having an end proximate to said opening of said receptacle and each of said plurality of tape means having attached thereto a plurality of unused pen needle assemblies in spaced-apart relationship.