Abstract
A needle tip (22) for being connected and disconnected in use from a needle tip support (16), comprises a needle (24) having a forward end and a rearward end and, a connector secured to the needle intermediate its ends. The connector comprises two arms (28) each extending outwardly and rearwardly relative to the needle (16) and configured to be coupled and uncoupled in use from said needle tip support, and the arms are disposed on opposite sides of the needle. Also disclosed are arrangements for storing, dispensing and later disposing such needle tips, as well as coupling interfaces between the needle tip and a needle support cap to which it is fitted in use.
Claims
1. A needle tip (22) for being connected and disconnected in use from a needle tip support (16), said needle tip including a needle (24) having a forward end and a rearward end, and a connector (25) secured to the needle intermediate its ends and comprising two arms (28) each extending outwardly and rearwardly relative to the needle and configured to be coupled and uncoupled in use from said needle tip support, the arms (28) being disposed on opposite sides of the needle.
2. A needle tip according to claim 1, wherein the connector includes a plug portion (26) through which said needle (24) extends, and which is adapted to engage a corresponding socket (18) in said needle tip support (16) in use, and which merges with the inner ends of said arms (28).
3. A needle tip according to claim 2, wherein said plug (26) includes a portion of non-circular cross-section for engaging said socket (18).
4. A needle tip according to claim 1 wherein said arms (20) are resilient and configured to snap around corresponding locations (20) on said needle tip support (16) in use, to allow coupling and uncoupling.
5. (canceled)
6. (canceled)
7. (canceled)
8. A needle tip (22) according to claim 1, in combination with a needle tip support (16), the needle tip support (16) having at least one region for cooperating with said arms to allow coupling and uncoupling of the needle tip.
9. A combination according to claim 8, wherein the needle tip support (16) has a tapered region (16′) having at least one surface (20) against which said arms may latch.
10. (canceled)
11. (canceled)
12. A needle tip support (16) for use in the combination according to claim 8, which includes an opening (18) for receiving in use said needle tip (24) with the needle extending therethrough, and at least one feature (20) remote from said opening for being engaged by the arms (28) of said needle tip (22) to allow releasable coupling of the needle tip to said needle tip support.
13. (canceled)
14. (canceled)
15. A needle tip support (16) according to claim 12, wherein said opening (18) has a non-circular cross-section.
16. A needle tip storage and dispensing arrangement comprising a housing (100), a needle tip magazine (110) having an array of needle tip holding locations (112) each for receiving in use a needle tip (22) as claimed in claim 1, the magazine being movably mounted in said housing.
17. A needle tip storage and dispensing arrangement according to claim 16, further including a drive arrangement (114) for moving said needle tip magazine (110) to present successive needle tip holding locations (112) at a coupling station.
18. A needle tip storage and dispensing arrangement according to claim 17, wherein said array is a linear array, and said drive arrangement (114) is operable incrementally to advance said needle tip magazine (110) linearly.
19. A needle tip storage and dispensing arrangement according to claim 17, wherein said needle tip magazine (110) includes seal elements (114) disposed intermediate each two needle tip holding locations (112) for slideably sealing against an interior surface of said housing (100).
20. A needle tip storage and dispensing arrangement according to claim 19, wherein the interior surface of said housing (100) is cylindrical and said seal elements (114) extend circumferentially around the exterior of the needle tip magazine (110).
21. (canceled)
22. A needle tip storage and dispensing arrangement according to claim 16, including an arrangement (122; 134, 136; 135, 138) for removing and storing used needle tip (22) after use.
23. A needle tip storage and dispensing arrangement according to claim 22, wherein said needle tip magazine is provided with at least one disposal recess (122) for storing a used needle tip.
24. A needle tip storage and dispensing arrangement according to claim 23, wherein said needle tip magazine includes a plurality of post-use storage recesses each associated with a respective needle tip holding location (112).
25. A needle tip storage and dispensing arrangement according to claim 24, wherein each needle tip holding location (112) defines a coupling axis along which in use a needle tip (22) is withdrawn and each disposal recess defines an uncoupling axis along which a needle tip is introduced into said disposal recess, with respective associated needle tip holding locations and post-use storage recesses being disposed with the coupling axis and the uncoupling axis generally coplanar.
26. (canceled)
27. (canceled)
28. A needle tip storage and dispensing arrangement according claim 23, wherein said at least one disposal recess (122 is provided with one or more latch elements (124) for latching in use a needle tip (22) to allow its removal from an injection device and retention in said disposal recess.
29. A needle tip storage and dispensing arrangement according to claim 28, wherein said needle tip (22) includes coupling arms (28) extending to either side of a needle for coupling the needle tip in use to a needle tip support, and said latch elements (124) capture the arms of the needle tip in use.
30. A needle tip storage and dispensing arrangement according to claim 23, wherein a storage volume (135) forms part of or is associated with said housing (100) and is configured to receive and store in use a used needle tip (22).
31. (canceled)
32. (canceled)
33. A needle tip storage and dispensing arrangement according to claim 16, wherein said array is an angular array, with the needle tip holding locations (212) spaced about the periphery of said needle tip magazine (210).
34. A needle tip storage and dispensing arrangement according to claim 33, further including a drive arrangement operable to advance said needle tip magazine angularly.
35. (canceled)
36. A needle tip storage and dispensing arrangement according to claim 16, wherein said needle magazine (110; 210) includes a sealing element (126; 226) for sealing each of said needle tip locations (112; 212) with a needle tip (22) contained therein.
37. A needle tip storage and dispensing arrangement according to claim 36, wherein said sealing element (126; 226) covers a plurality of said needle tip locations (112; 212) and is bonded to said needle tip magazine (110; 210) by a bond that allows said sealing element progressively to be peeled from each of said needle tip locations in turn.
38. A needle tip storage and dispensing arrangement according to claim 37, wherein a deflector (128; 228) forms part of or is associated with said housing (100; 200) and is disposed to cause said sealing element (126; 226) to peel away from said housing as said needle tip magazine (110; 210) is moved to present a needle tip at said coupling station.
39. A needle tip storage and dispensing arrangement according to claim 38, wherein said sealing element (126; 226) is constrained to pass down a passage (130; 230) as it peels off said needle tip magazine on movement of said needle tip magazine.
40. (canceled)
41. (canceled)
42. (canceled)
43. (canceled)
44. (canceled)
45. (canceled)
46. (canceled)
47. (canceled)
48. (canceled)
49. (canceled)
50. (canceled)
51. (canceled)
52. (canceled)
53. (canceled)
54. (canceled)
55. (canceled)
56. (canceled)
Description
[0036] The invention may be performed in various ways, and, by way of example only, various embodiments thereof will now be described in detail, reference being made to the accompanying drawings in which:
[0037] FIG. 1 is an exploded view of an embodiment of a needle tip system;
[0038] FIG. 2 is a detailed cutaway view of an embodiment of a dispensing socket;
[0039] FIG. 3 is a detailed cutaway view of an embodiment of a removal socket;
[0040] FIG. 4 is a cross-sectional view of an embodiment of a dual dispenser/disposal arrangement;
[0041] FIGS. 5(a) to (e) are side and end views on another embodiment of a needle tip and needle tip support;
[0042] FIGS. 6(a), (b), (c) and (d) are side and end views on another embodiment of needle tip and needle tip support;
[0043] FIGS. 7(a), (b), (c) and (d) are side and end views on another embodiment of needle tip and needle tip support;
[0044] FIGS. 8(a) and (b) are vertical section lines taken perpendicularly through a needle tip storage and dispensing arrangement;
[0045] FIGS. 9(a) and (b) are a vertical section view taken through an embodiment of needle tip storage, dispensing and disposal arrangement and a side view of an inner magazine, respectively;
[0046] FIGS. 10(a) and (b) are section views taken on lines A-A of FIG. 9 showing the dispensing and disposal sockets arranged perpendicularly;
[0047] FIGS. 11(a), (b) and (c) are vertical section views through another embodiment of needle tip storage and dispensing arrangement shown prior to dispensing the first needle tip, after dispensing the first needle tip, and having dispensed the final needle tip respectively;
[0048] FIGS. 12(a) and (b) are vertical section and top views respectively of another embodiment of storage, dispensing and disposal arrangement with a facility for receiving used needle tips;
[0049] FIGS. 13 (a) and (b) are vertical section and top views respectively of another embodiment of storage, dispensing and disposal arrangement with a facility for receiving used needle tips;
[0050] FIGS. 14(a) to (f) are three horizontal section views taken through a rotary version of a needle tip storage, dispensing and disposal arrangement shown before dispensing the first needle tip, after dispensing the first needle tip, and having dispensed the final needle tip respectively, and top, side and vertical section views;
[0051] FIGS. 15(a) to (d) are section views through an embodiment of an arrangement for docking and connecting a needle tip support with a pre-wrapped needle tip;
[0052] FIGS. 16(a) to (d) are front and side views and corresponding section views of an embodiment of a needle tip packaged in a wrapper;
[0053] FIGS. 17(a) and (b) are views of a further embodiment of a needle tip packaged in a wrapper;
[0054] FIGS. 18(a) and (b) are a section view through a packaging snap connector for the embodiment of FIG. 17 applied to the packaging, and a section view illustrating stacking connection of the connectors respectively, and
[0055] FIGS. 19(a) and (b) are perspective and side views of another embodiment of needle tip storage, dispensing and disposal arrangement.
[0056] Referring initially to FIGS. 1 to 4, the front end of an injection device 10 containing a cartridge or syringe is provided with an externally threaded collar 12 behind which is located a pierceable seal or septum 14 of a cartridge containing the medicament to be injected. The externally threaded collar 12 is of the type designed to receive an internally threaded needle tip of conventional form such as our Unifine® product. However, the needle tip system of this embodiment is made up of a needle support cap 16 having a rear cylindrical part 16′ and a forward frusto-conical part 16″, with the cylindrical part 16′ being internally threaded so that the support cap 16 can be screwed onto the threaded collar 12 and left there during successive changes or needle tip. The frusto-conical part 16″ of the support cap 16 has a central aperture 18. Externally, at the merger between the cylindrical part and the frusto-conical part, there is provided an annular groove 20.
[0057] The needle tip 22 is very compact and comprises a double ended needle 24 having a rearward sharpened end for piercing the seal 14 when the needle tip is connected to the support cap 16, and a sharpened patient end. Moulded or otherwise suitably secured to a central portion of the needle is a connector 25 of slimline form comprising a boss 26 and two rearwardly and outwardly extending arms 28. At the inner ends of each of the arms is a toothed rib 30. The needle tip may be introduced and connected to the support cap 18 by passing the rear end of the needle and the rear portion of the boss 26 through the aperture 18 (piercing the seal) until the inner surfaces of the arms lie against the frusto-conical portion of the support cap and the toothed ribs 30 snap into the annular groove 20 to clasp the needle tip securely against the support cap.
[0058] The boss 26 releasably plugs into the aperture 18 to provide stability for the needle. The injection device may then be used in the usual manner. After use, the needle tip may be unclasped from the support cap by using a tool (to be described below) to lift the toothed ribs 30 out of the annular groove 20 and pulling the needle tip 22 away so that it can be disposed of safely. Due to the slimline profile of the needle tip, it allows a far greater packing density of the needle tip in a restricted space for either dispensing or safe disposal.
[0059] In preferred embodiments, the interface between the toothed ribs 30 and the annular groove 20 is designed so that the toothed ribs cannot be released by pulling the needle tip forwardly by the needle 24 or by the boss 26. The needle tip holds on to the support cap tightly by the snap action and can only be dislodged by lifting the toothed ribs out of the groove laterally. For example the contacting surfaces of the toothed ribs and the groove may be inclined at an angle greater than 90° to the needle axis so the toothed ribs are pulled into tighter engagement with the groove if an attempt is made manually to pull the needle tip forwardly off the support cap. Instead, needle tip removal requires an implement, tool or removal surface to be inserted behind the rear facing ends of the arms to lift them clear of the groove and to push the needle tip away from the support cap. This encourages compliance because users find it difficult or impossible to remove unless they use specific removal features of the type described below, which then drop the used needle tip directly into the sharps container.
[0060] FIGS. 2 to 4 show a dispensing arrangement having an outer housing 32 defining a dispensing socket 34 and a removal/disposal socket 36. Referring to the dispensing socket 34, this allows a user to insert the support cap of an injection device into the socket and pick up a needle tip. A needle tip 22 (or a stack thereof) is supported on a cradle 38 having a central passage for receiving the forward end of the needle 24. Where the dispensing socket contains a stack of needle tips, the cradle may be sprung to advance upwardly each time a needle tip is dispensed. Within the dispensing socket 34 are two diametrically opposed lugs 40 which temporarily restrain the needle tip 22 and which also may allow the user angularly to orient the injection device with the needle tip 22 for correct coupling.
[0061] The removal/disposal socket 36 is similarly sized to the dispensing socket 34 to allow a user to insert the support cap 16 and attached needle tip 22 into the socket. The socket 36 is provided with a number of axially directed claw fingers 42 configured to snap around the rearward facing end of the arms 28 of a needle tip when inserted into the socket. In use a user may push the support cap 16 with attached needle tip 22 into the socket 36 and then remove the needle tip simply by pulling the injection device away from the outer housing 32, leaving the used needle tip trapped therein. A suitable void may be provided below the removal socket into which used needle tips may fall once detached from the injection device, with a suitable baffle or other arrangement to prevent the re-emergence thereof.
[0062] FIGS. 5 to 7 show a number of different variations of interface between a needle tip 22 and a support cap 16. In each case, the needle tip 22 is of generally the same form except in FIG. 6 where the spread of the arms 28 is not as great as the other embodiments. In the arrangement of FIGS. 5(a) and (b), there is a central trapezoidal-shaped rib 44 of substantially uniform thickness with notches 46 at opposite ends into which the toothed ribs 30 of the arms 28 of the needle tip 22 clip. In order to provide a keying feature, two lugs 48 may protrude from either side of the trapezoidal section, as shown in FIG. 7. The rearward end of the boss may carry ribs or splines 50 to provide the boss with a cruciform cross-section, and the opening 18 in the support cap 16 may be complementarily shaped to prevent the needle tip 22 from rotating and potentially uncoupling from the support cap 16. In FIGS. 6(a) and (b), the support cap 16 is of generally frusto-conical shape as in the cap of FIG. 1, but is provided with a central relieved portion 52 into which the arms 28 of the needle tip slot, so that the forward faces of the arms 28 and the frusto-conical portion 16.sup.1 are flush.
[0063] Referring now to FIGS. 8 to 14, there are shown various forms of needle tip dispenser for keeping the needle tips 22 in a sterile condition until they are required for use, and then presenting them for being picked up by the needle support cap 16. Thus, in the embodiment of FIGS. 8(a) and (b), an outer housing 100 slideably receives an inner magazine 110 which includes a vertical array of needle storage slots 112. The magazine is provided with a number of ‘O’ ring seals 114, one between each pair of storage slots 112 respectively, and one at the top and bottom, so as to preserve the sterility of the remaining needle tips 22 when one is exposed for being picked up by the needle support cap 16. An indexing mechanism 114 is provided to shift the magazine downwardly by suitable increment upon each activation to present a next needle tip. In this arrangement an elongate fir tree shaped recess 116 is provided in the magazine 110 which acts like a ratchet surface in combination with a button 118 having flexible fingers 120 at the bottom end of a stem 122. Each time the button 118 is depressed, the magazine 110 is advanced by an amount equivalent to the spacing between two needle storage slots 112, to present the next one ready for the injection device.
[0064] This arrangement can be modified to allow for needle disposal as well as needle dispensing. Thus, in FIGS. 9 and 10, the magazine 110 of is provided with a series of disposal slots 122 extending at 90° to each needle storage slot. The disposal slots 122 include latch fingers 124 past which the ends of the arms 28 of a needle tip 22 snap when a needle tip is introduced into the slot. Withdrawing the injection device then unclasps the needle tip from the needle cap support 16, leaving the needle tip 22 trapped inside the disposal slot 122.
[0065] Referring now to FIG. 11, this arrangement is generally similar to that of FIG. 8 except that, instead of using spaced ‘O’ ring seals to preserve sterility, the needle tips are initially sealed in their storage slots by means of a suitable elongate tape 126 of paper, foil, etc. As before, the magazine is indexed down to present successive needle slots 110 ready to allow the injection device to pick up a next needle tip. The housing is provided with a scoop edge and deflection arrangement 128 which, as the magazine is indexed down, peels the foil tape away from the magazine to reveal the next slot 112, with the peeled foil passing into an elongate slot 130 in the housing. At its upper end, the elongate slot 130 has a window 132, and the slot 130 and the window 132 are designed with reference to the length of the foil tape 126 such that the end of the foil tape becomes visible in the window 132 as the magazine is indexed to present the last available needle slot. This provides the user with a warning when the last tip has been dispersed.
[0066] The arrangement of FIG. 11 may be modified to allow removal and disposal of used needle tips. Thus, in FIGS. 12(a) and (b), a separate needle removal compartment 134 is provided on a side of the housing opposite the elongate slot 130. The removal compartment includes an aperture at its upper end with latch arms 136 designed to snap around the arms 28 of the needle tip 22 when presented in the aperture, with the needle tip separating from the injection device as it is pulled away from the dispenser, the needle tip 22 then falling down into the base of the removal compartment 134 as shown. Instead of providing a separate removal compartment 134, use may be made of the expanding void 135 that is defined between the upper end of the magazine 110 and the housing 100 as the magazine 110 is indexed downwardly to present each new needle tip. Thus, in FIGS. 13(a) and (b), the upper end of the housing is provided with a removal slot 138 with latch arms 136 similar to those of FIG. 11. A user may offer up the injection device so that the needle tip 22 is captured and removed and then subsequently drops into the void 135 between the magazine and the housing after separation.
[0067] Referring now to FIG. 14, the arrangement of FIG. 8 may be configured to be angularly indexed as opposed to linearly indexed. Thus, in this arrangement there is a central disk shaped magazine 210 with regularly extending needle tip slots 212 covered initially by a suitable foil 226 or other seal. The magazine is contained for rotation within an outer housing 200 which is provided with an annular passage 230 for receiving the seal as it is peeled off the surface of the magazine. The housing includes scoop surface 228 to achieve this. The magazine rotates around a central shaft and a ratchet 214 arrangement is provided to constrain rotation in one direction only, and upstanding tabs 237 are provided to allow manual rotation. As seen in FIG. 14(c), the housing may be provided with a central void 235 communicating with a central removal aperture 238 having removal latches 236 designed to capture a needle tip 22 when it is offered up to the aperture.
[0068] It will be appreciated that the interfaces between the needle support cap and the needle dispensing and optional removal arrangements may take any of the forms shown in FIG. 1 or 5 to 7.
[0069] Referring now to FIG. 15, the needle tip 22 of the type described above may be presented in the form of individual, heat-sealed packets 300 to maintain sterility and which must be opened to allow access to the needle, prior to fitting the needle tip to the injection device. In the arrangement of FIG. 15, a needle tip 22 in a heat-sealed sleeve 300 is located in the well 302 of the base 304 of an applicator device 306. The applicator device comprises the base 304 and an apertured plunger 308 that is biased by a spring 310 to a rest position at a distance from the base. The base also includes two upstanding ramps 312 positioned to either side of the well (see FIG. 15(b)). In use, an injection device 10 is applied to the upper end of the plunger 308 with the cap 16 in the aperture of plunger 308, and then the injection device and the plunger 308 together pushed downwardly. This has the effect of trapping parts of the wrapper sleeve 300 between the ramp and the aperture of the plunger 38 so that the wrapper is first drawn tightly against the non-patient end of the needle 24 to puncture the wrapper, and then drawn away from the needle as the plunger draws spaced portions of the wrapper down the ramp. At the bottom of the stroke of the plunger, the needle support cap 16 snaps into engagement with the needle tip 22 so that when the injection device is pulled clear of the applicator, it carries the needle tip, leaving the wrapper 300 behind.
[0070] Instead of providing an external mechanism or adapter to spread the wrapper away from the needle once it has been punctured thereby, an internal mechanism may be provided within the wrapper that achieves this function and also provides initial protection for the exposed needle portions. In FIG. 16, the needle tip 22 is initially provided with its forward needle portion located in a bore 350 in a lower protector component 352. The lower protector component 352 has a tapered skirt 354 and opposed legs 356 extend rearwardly to carry a protection ring 358 at their upper ends. An upper protector component 360 also with a tapered skirt 362 is arranged opposite the lower component 352 to provide a waisted portion, and receives the arms 28 of the needle tip 22 and is slideably mounted on the legs 356 of the lower component. This combination, including the needle tip, is located inside the outer sleeve 300. When a user wishes to prepare the package to allow the needle tip to be connected to an injection device, they pinch the protection component about its waist. This action causes the two components to separate, and the needle tip 22 and the non-patient end of the needle tip move upwardly with the upper component 360 to pierce the wrapper 300. At the same time, the effective elongation of the protection component causes the wrapper 362 to be drawn tightly across the ring 358 as it is pierced by the needle so that it is drawn clear to allow the needle tip to be picked up cleanly by the injection device.
[0071] In another arrangement illustrated in FIG. 17, the needle tip is provided in a heat-sealed wrapper 300 with just a rigid shroud 364 to prevent damage to the needle before use. The packet may have a simple tear notch 366 to allow access to the needle tip 22. Here the user may simply rip the package at the tear notch to open the packet, and then introduce the injection device to access and clip on to the needle tip.
[0072] In order to allow several of the packets as shown in FIG. 17 to be connected together without compromising the sterility of the package, they may employ the two part clip ring that is illustrated in FIG. 18(a). The ring comprises two complementary parts 366, 368 and which can be located to either side of the opposed walls of a wrapper sleeve 300 and then pushed together to clip non-releasably to each other. The two part component, once assembled, provides a male plug 370 that can clip into a female socket 372 of an adjacent component, as seen in FIG. 18(b), so that a stack of wrapped needle tips may be assembled.
[0073] In another embodiment, illustrated in FIGS. 19(a) and (b), a magazine 510 of needle tips is of flat rectangular form and slideably received in a drawer slot 512 of a housing 500. The forward ends of the needle tips are received in bores 514 in the magazine, and the rearward ends may carry shields 516. A removal compartment and socket 522 with latches 524 to capture a used tip is provided alongside the drawer slot and is sized to receive the needle tips as they are removed by the latches 524. The recess may include guide grooves in opposite walls to align used needle tips.
