AU2001250170B2 - Syringe retaining device and spoon for injectables - Google Patents

Description

WO 01/78806 PCT/AU01/00443 Syringe retaining device and spoon for injectables Field of the Invention This invention relates to devices and kits for performance of an intravenous injection, particularly of controlled substances by intravenous drug users which may be referred to as "fitkits" or "fitpacks". More particularly, the present invention relates to a syringe retaining device which may be incorporated in such kits both for holding syringes prior to use in an injection and retaining them for disposal after use.

Prior Art It is well recognised that controlled substances, particularly heroin, are commonly used being administered intravenously. Accordingly, a public health problem arises. The problem has two related aspects.

Firstly, the hazards of used needles are well recognised. It is well known that a number of diseases may be transmitted by re-use of syringes. For example, the transmission of AIDS and Hepatitis viruses such as Hepatitis C through re-use of needles is now well documented.

Transmission of disease is not only possible through re-use of needles but indeed may be caused by so-called needle stick injury in which a needle inadvertently punctures the skin of a person allowing transmission of a virus to that person. A number of proposals for dealing with such hazards have been documented in the patent literature. Most such proposals are predicated on use in a therapeutic environment in which many needles are used on a daily basis and a centralised disposal unit may readily be used for the purpose of needle disposal. In such environments, the risk of re-use is relatively small and the prime concern is to ensure that disease transmission through needle stick injury does not occur.

Real hazards remain, however, in the non-therapeutic environment where availability of a centralised needle disposal system is problematic for IDU's. Even if such disposal facility is available there remains the problem that accidents may occur while conveying a used needle to the disposal facility. It is understood that, while there has been a dramatic increase in the number of syringes distributed and collected for disposal units with different sharps containers, surveys have WO 01/78806 PCT/AU01/00443 2 indicated that a major problem with needle syringe exchange programs is availability of disposal units on both a locality and time frame basis.

To address that problem, the present Applicant developed a syringe disposal device that addressed the problems described above at reasonable cost and accessibility to the IDU. That syringe disposal device is described in the Applicant's co-pending PCT Patent Application No. PCT/AU00/01204, "Syringe Disposal Device", priority date 30 September 1999, and the contents of which are hereby incorporated herein by reference.

More specifically, that syringe disposal device is suitable for disposal of a single syringe having a needle, a barrel, a plunger and, on the barrel or plunger, a transversely extending portion or flange. The disposal device includes a needleencapsulating portion, a syringe barrel encapsulating portion; and a syringe retention portion. The syringe retention portion has an open end for insertion of a syringe and an opposed end communicating the retention portion with the syringe barrel encapsulating portion. Engagement means, such as lugs, are provided at or proximate the opposed end for retaining a syringe within the disposal device after passage of the syringe flange past the engagement means by an interference fit.

Such disposal devices may be provided in so-called "fitkits" or "fitpacks" which include a syringe, a disposal device and possibly distilled water and filters to enable an injection to occur. Such fit kits are publicly beneficial because by making a clean injection and disposal convenient to perform, use of such devices is promoted and public safety is achieved. That, however, represents the second aspect of the problem. Infection risks will continue to be taken regardless of fit kits if such are not reasonable in cost and convenient to use.

Here a problem may nevertheless arise. The fitkit may contain a receptacle such as a "spoon" or other suitable container for mixing the components of an injection. Generally, the spoon is a concave shaped or partly spherical receptacle connected to a handle, It could be seen as a cup-holder device. Currently, it is difficult to draw all the injectable solution from such a concave shaped receptacle into the syringe. Accordingly, valuable material to the IDU may be lost to that person's resentment. Further, there is a tendency to PCT/AU0 1/00443 Received 21 March 2002 3 damage the extremely fine sharp edged tip of the needle when that tip contacts the spoon surface. This may make the injection more difficult.

Still further, conventional spoons may put the IDU at risk of burns when the receptacle is heated. This is obviously undesirable.

An important consideration in minimising hazard through contaminated syringes involves the identification of a contaminated needle by a user prior to use. Whilst the disposal of contaminated syringes provides a problem after use, if syringes are not disposed of in a disciplined and routine manner it is possible that a subsequent user will be unaware of the prior use. It is therefore an holistic problem that following use of a syringe leading to its contamination a first user must have means in which to dispose of the syringe and also there must be some safeguard for any potential subsequent user to inform himself that a syringe has in fact been used.

Summary of the Invention It is therefore an object of the present invention to develop a syringe disposal device that is convenient to use, which minimises the possibility of a needle being able to be reused following retention, and generally increasing efficacy of the syringe disposal device, and associated peripherals.

Therefore, in one aspect of the invention there is provided a syringe retaining device for encapsulating a syringe and a needle attached thereto including an elongate tube openable at one end for insertion of the syringe, and closed at an opposing closed end wherein at least one step is provided on an inside surface of the device intermediate said closed and openable ends to contact and cause damage to the needle, as force is applied to the syringe during insertion.

In the case where the device has a needle encapsulating portion, a syringe barrel encapsulating portion and syringe retention portion, the inner surface may advantageously be a surface of the needle encapsulating portion and/or syringe barrel encapsulating portion.

A number of steps may be provided on the inside surface of the device, the number being advantageously selected in accordance with probability data that are empirically or mathematically derived. The present Applicant has found that increasing the number of steps on the inner surface increases the possibility of AMENDED SHEET

IPENAU

WO 01/78806 PCT/AU01/00443 4 the needle contacting the inner surface with sufficient probability of the impact force reducing the needle to an unusable condition.

It is most advantageous that multiple steps of equal or variable length (both in width and in distance apart from the minor diameter of the end of the morse taper as disclosed in Australian Provisional Patent Application No. PQ3204 be formed in the inner surface of the needle encapsulating portion of the syringe retaining device which may be a disposal device or syringe retains prior to use and disposal. These terms may be used interchangeably. Such formation may be distinguished from that taper concept in which the stepped configuration is designed to neatly accommodate portions of the syringe to be disposed of.

Without wishing to be bound by any theory, it has been empirically calculated that the probability of the needle impacting the inner surface of the syringe retaining device of PCT Patent Application No. PCT/AU00/01204 with sufficient force to render the needle unusable is approximately 55%. Specifically, in such instances, the needle impacts the inner surface with sufficient force that the needle collapses or concertinas. In some cases, if the syringe retaining device is made of a soft material, the needle may penetrate the outside wall of the syringe retaining device, particularly in the region of the needle encapsulating portion or the syringe barrel encapsulating portion. A harder, preferably polymeric material or laminate, may be used to avoid this problem and a shield of such material may be placed, for example at the transition between the syringe barrel encapsulating portion and needle encapsulating portion or at other vulnerable positions.

If steps, or corrugations, are formed in the needle encapsulating portion or transition or interface between the needle encapsulating portion and syringe barrel encapsulating portion, the probability of the needle undergoing a destructive impact with the inner surface increases. It has been estimated that formation of about five to six steps in this region of the syringe disposal device increases the probability of destructive impact to greater than 90%, this being an advantageous outcome in terms of needle destruction.

The length of the needle encapsulating portion or length of the steps may also increase the probability of the needle undergoing a destructive impact with WO 01/78806 PCT/AU01/00443 the inner surface as constituted by an inner surface of the wall defining the needle encapsulating portion of the syringe retaining device.

In a further aspect of the invention, the axial distance between a syringe outer surface and an inner surface of the syringe retaining device may be selected to maximise the bending moment or angular compressive force on the needle, thereby reducing the force required to destroy/concertina the needle or the IDU's perception of the force required to insert the used syringe into. the syringe retaining device.

The stepped configuration may be such as to increase the probability of the needle being destroyed before the syringe itself, as opposed to the needle, contacts interference points, as may be created by a morse taper as described in the Applicant's PCT Patent Application No. PCT/AU00/01204, previously incorporated herein by reference. In accordance with the invention, if resistance is encountered by the needle early and the stepped configuration is employed, a longer duration of resistance may be achieved. At the same time, the maximum resistance is reduced.

Nevertheless, it is important that the force/resistance required is the minimum possible that the IDU perceives that the syringe has been placed into a safe position.

In a further aspect of the invention there is provided a syringe retaining device for encapsulating a syringe, having a needle, a barrel, a plunger and, on the barrel or plunger a transversely extending flange, said device including a syringe retention portion including flange engaging means, which engages said flange to retain said syringe in said device a needle encapsulating portion with a barrel encapsulating portion intermediate the syringe retention portion and needle encapsulating portion, wherein at least one step is provided on an inside surface of the device to contact and cause damage to the needle, as force is applied to the syringe during insertion.

The disposal device may advantageously have a body of tapered form. In particular, the syringe retention portion may advantageously be tapered. The syringe retention portion may have greater external dimension along substantially its whole length than an outer diameter of the syringe barrel encapsulating portion WO 01/78806 PCT/AU01/00443 6 and the needle encapsulating portion. Other characteristics of the syringe retaining device may be as described in PCT Application No. PCT/AU00/01204; the contents of which are hereby incorporated herein by reference.

Such a device may include a sub-portion as described below.

In a still further aspect of the invention, there is provided a syringe retaining device for encapsulating a syringe and a needle attached thereto including an elongate tube openable at one end for insertion of the syringe, and closed at an opposing end wherein a sub-portion is located adjacent the openable end, to indicate use wherein such previous use has occurred.

The sub-portion may form part of a syringe retention portion of a syringe retention portion of a syringe retaining device as described in the Applicant's PCT Patent Application No. PCT/AUO0/01204, the contents of which are hereby incorporated by reference.

In a preferred embodiment, the sub portion may be an element which is irreversibly deformed or damaged in a manner that may indicate to a potential subsequent user that the syringe retaining device has been used previously or interfered with. The syringe retaining device of this aspect of the present invention may therefore prevent reuse by a potential subsequent user.

Detachment or partial detachment of the sub portion from the device, for example, by snap off action may provide indication of previous use.

Alternatively, indication of prior use may involve a visually distinctive marking on the device, for example crazing of the plastic. The first user may only use a new syringe located within the syringe barrel encapsulating portion by detaching or partially detaching a sub portion from the device. Following use, if that user then replaces the used syringe within the barrel encapsulating portion but without permanently engaging said syringe within the syringe retention portion then any potential subsequent user may infer that the syringe is contaminated on inspection of the detached or semi detached sub portion.

In a preferred embodiment the sub portion may be a closure means for closing the open end of the syringe retaining device.

In one aspect of the invention the syringe disposal device may be used as a means for transporting and storing unused syringes and then the closure WO 01/78806 PCT/AU01/00443 7 means may be used to close the open end of the disposal device. If a first user is then required to remove the closure means in order to extract the new syringe for use, the closure means may be irreversibly detached such that a potential subsequent user may infer that a syringe within the retaining device, but having the closure means removed, has already been used.

The closure means may be integrally connected to the device through detachment means. Conveniently, the detachment means may be a weakened portion of the closure means or the device wherein a first user may detach the enclosure means by applying a flexural or torsional force to the enclosure means thus breaking the weakened portion.

The weakened portion may be a continuous thin section. Alternatively the weakened section may comprise a finite number of discrete members for attaching the sub-portion to the device wherein on application of a force by a first user the discrete members may have a lower failure resistance than either the closure means or the remainder of device. The user is then required to apply a force in order to detach the closure means, such detachment being preferably irreversible. In a preferred embodiment, the enclosure means may be a cap.

By incorporating a sub-portion which indicates previous use, preferably by irreversibly damage thereof, a potential user is warned that the syringe or retaining device may have been tampered with or used previously and should not be reused.

In a still further aspect of the invention, there is provided a syringe retaining device for encapsulating a syringe, having a needle, a barrel, a plunger and, on the barrel or plunger, a transversely extending flange, said device including a syringe retention portion including flange engaging means which engages said flange to retain said syringe in said device and a needle encapsulating portion with a barrel encapsulating portion intermediate the syringe retention portion and needle engaging portion wherein a sub-portion is located adjacent the open end, such that on use of the device the sub-portion is irreversibly damaged.

Such syringe retaining device may incorporate a stepped configuration as above described.

WO 01/78806 PCT/AU01/00443 8 The syringe retaining/disposal device of the above aspects of the invention or the Applicant's PCT Patent Application No. PCT/AU00/01204, may be retained in a holder which includes a syringe, and may include accessories for use in an injection. Such accessories may include distilled water or other solvent for an injectable to be used in the injection and other equipment, such as spoons, for injection preparation. The receptacle, as described below, may also be advantageously included in the holder.

Such a holder should likewise be fabricated from a low cost polymeric or metallic material. If the syringe is provided with the holder, the syringe may be located within the disposal device but in a non-engaged position such that withdrawal of the syringe from the device is readily possible.

Such kits may be produced to have different combinations of contents and may be colour coded to indicate the nature of their contents such that users may readily be informed of suitable packaged holders for their use.

Such kits would be readily available from pharmacies in a package that facilitates anonymity of the transaction. This will greatly reduce discomfort to both the pharmacist and the intravenous drug user in a transaction carried out in a busy pharmacy. Reduction in barriers such as this at the pharmacy-intravenous drug user level is important to adoption of safe disposal devices of the kind offered by this invention. In so doing, ready availability of such disposal devices and kits may be assured. User of the disposal device and the kit generally will also reduce the risk of cross-infection between used and clean syringes.

In a still further aspect of the invention, there is provided a receptacle having a wall defining a vessel for preparation of an injectable solution there being provided in the wall a depression forming a sump to which injectable solution drains during drawing up of the injectable solution into an injection device.

The defining wall of the receptacle may be generally concave to form, desirably, a spoonlike receptacle or spoon. It will be understood, however, that other shapes and profiles could equally well be used. That defining wall may be discontinuous with a wall of the depression in that the transition between them is not smooth. The shapes of the vessel and depression may be the same or WO 01/78806 PCT/AU01/00443 9 different. The shape of the depression is not particularly important though it could be hemi- or part-spherical. The dimension of the depression may be selected to easily, perhaps neatly, accommodate a needle tip.

The depression may be located at or proximate the maximum depth of the vessel. This may apply in either the position the vessel is held or located.

The receptacle may be provided with a handle portion to allow an IDU to hold the receptacle more easily. The handle portion may incorporate a guard portion or flame guard to protect the user from a flame is applied to the base of the receptacle.

Conveniently, the sump may be fitted with an appropriately sized filter during preparation of an injection. Such a filter promotes two things. Firstly, the filter allows harmful solids to be filtered out of the drawn-up solution. It also provides a "cushion" for the needle tip reducing the chance of the fine sharp edge on the tip getting damaged during the draw up process. The filter may be prefitted into the sump and would generally be of liquid absorbent material, such as cotton. The receptacle or spoon may be used in association with the syringe retention device as above described or described in the Applicant's PCT Patent Application No. PCTfAU00/01204, previously incorporated herein by reference.

However, the receptacle or spoon may be manufactured and supplied separately.

In an advantageous embodiment, the receptacle would be incorporated within a holder which also includes a syringe and a syringe disposal device.

Optionally, the holder could also include distilled water and filter(s) for use in preparation of an injection.

The receptacle may be formed into the holder or may be detachable therefrom. In the latter case, the receptacle or holder may be provided with connection means for connecting holder to the receptacle. In one embodiment, a holder can be provided with connection means, such as grooves, on its base o allow location and connection of receptacle holder to provide a more stable platform for preparing an injection.

If the holder is in the form of a box, the receptacle may be connectable to a wall or walls of that box by suitable connection means. For example, the spoon may have a rim defined at its periphery, which rim may clip to the box wall. The WO 01/78806 PCT/AU01/00443 box or holder wall may be formed with complementary connection means such as a rib that may cooperate with a groove or slot formed in the rim. The positions of the rib and groove or slot could of course be inverted. A number of such connection means could be provided about the periphery of the spoon. The whole may be wrapped in plastic film or other suitable packaging material.

The receptacle or spoon may be moulded into the holder either externally or internally thus integrating the receptacle and holder.

In this manner, equipment may be provided allowing for safe and convenient and inexpensive preparation of an injection followed by safe disposal.

Public health is thereby promoted.

Brief Description of the Drawings The invention may be more completely understood from the following description of preferred embodiments of the syringe retaining device and receptacle of the present invention. In the drawings: Figure 1 shows a side section of a syringe retaining device in accordance with the disclosure of PCT Patent Application No. PCT/AU00/01204 showing a syringe in a non-engaged position; Figure 2 shows a side section of a syringe retaining device in accordance with the disclosure of PCT Patent Application No. PCT/AU00/01204 showing a syringe in an engaged position; Figure 3 shows a part section view showing a portion of the syringe barrel encapsulating portion and the needle encapsulating portion of a syringe retaining device in accordance with the disclosure of PCT Patent Application No.

PCT/AU00/01204; Figure 4a to 4d show a schematic side section of the syringe and syringe retaining device in accordance with the disclosure of PCT Patent Application No.

PCT/AU00/01204 showing needle impact with varying portions of the syringe retaining device; Figure 5 shows a part side section of the needle encapsulating portion of the syringe retaining device in accordance with the disclosure of PCT Patent Application No. PCT/AU00/01204; WO 01/78806 PCT/AU01/00443 11 Figure 6 shows a part side section of the needle encapsulating portion of the syringe retaining device of a first embodiment of the present invention; Figure 7a to 7d show a schematic side section of a syringe and syringe retaining device in accordance with the first embodiment of the present invention showing needle impact with varying portions of the syringe retaining device; Figure 8 shows a side section of a syringe in retained position within a syringe retaining device of the first embodiment of present invention; and Figure 9 shows a detail side section view of the needle encapsulating portion and needle in retained position of Figure 8.

Figure 10 shows a side section of a syringe disposal device having a detachable cap; Figure 11 shows a side section of a syringe disposal device incorporating a sub-portion in accordance with a second embodiment of the invention; Figure 12a shows a detail section of a first embodiment of the syringe disposal device in accordance with the invention as shown in Figure 11; Figure 12b shows a detail section of a second embodiment of the syringe disposal device in accordance with the invention shown in Figure 11; Figure 12c shows a detail section of a third embodiment of the syringe disposal device in accordance with the invention shown in Figure 11; Figure 13a shows a detail section of a fourth embodiment of the syringe disposal device in accordance with the invention as shown in Figure 11; Figure 13b shows a further detail section of the fourth embodiment of the syringe disposal device in accordance with the invention as shown in Figure 11; Figure 14 is a syringe holder as described in PCT Patent Application No.

PCT/AU00/01204; Figure 15 is a plan view of a receptacle in accordance with a third embodiment of the present invention; Figure 16 is, an elevational cross-section of the receptacle shown in plan view in Figure Figure 17 is a detail plan view of an assembly of a syringe holder and receptacle as shown in Figures 15 and 16; WO 01/78806 PCT/AU01/00443 12 Figure 18 is a detail elevational cross-section view of the assembly shown in plan in Figure 17; Figure 19 is a front perspective view of a receptacle in accordance with a second embodiment of the present invention; Figure 20 is a rear perspective view of the receptacle of Figure 19; Figure 21 is a bottom perspective view of the receptacle of Figures 19 and Figure 22 is a plan view of a syringe holder showing location of a receptacle of Figures 19 to 21 of the present invention in stored and operative positions.

Figure 23 is a side elevation view of a syringe holder showing location of the receptacle of Figures 19 to 21 in stored and operative positions; Figure 24 is an elevational cross-section view of the receptacle of Figures 19 to 22 showing a needle immersed in a sump of the receptacle; Figure 25 is an elevational cross-section view of the receptacle of Figures 19 to 22 showing the receptacle of Figure 6 having a filter fitted in the sump for filtering; Figure 26 is an elevational cross-section view of a syringe holder showing location of the receptacle of Figures 15 and 16 in an operative position; Figure 27a is a bottom view of a further construction of syringe holder having receptacle moulded into an external surface thereof; Figure 27b is a cross-section view along axis AA-AA of Figure 27a; Figure 27c is a cross-section view along axis BB-BB of Figure 27b; Figure 27d is an end view of the syringe holder of Figures 27a to 27c; Figure 27e is a top view of the syringe holder of Figures 27a to 27d; Figure 28a is a side section view of a still further construction of syringe holder having a receptacle moulded into an internal surface of the syringe holder; Figure 28b is a cross-section view of the syringe holder of Figure 28a along axis CC-CC of Figure 28a; and Figure 28c is a bottom view of the syringe holder of Figures 28a and 28b.

WO 01/78806 PCT/AU01/00443 13 Detailed Description of Preferred Embodiments of the Invention Referring firstly to Figures 1 to 3 and 5, there is shown a syringe retaining device 10 as described in PCT Patent Application No. PCT/AU00/01204, "Syringe Disposal Device", priority date 30 September 1999, the contents of which are hereby incorporated herein by reference. Accordingly, it will not be necessary to provide a further detailed description of the device 10 here except to say that the device may be used both for retaining a syringe prior to use in an injection and retaining it in device 10 after use for disposal. In the following description, the term syringe disposal device will be used for purposes of illustration and for practical conveniences.

In summary, the syringe disposal device 10 includes a needle encapsulating portion 12, a syringe barrel encapsulating portion 14 and a syringe retention portion 16. The syringe disposal device 10 is suitable for disposal of any kind of syringe prior to use in an injection. The syringe 30, as shown in the drawings, is of a conventional type having a needle 33, a hub 34, a needle carrier a barrel 38 and a plunger portion 38a which, on engagement with the engaging means 20, retain the syringe 30 within the disposal device It may be noted that needle encapsulating portion 12 tapers sharply, being in the form of an inverted cone. The inner surface of wall 12a defining this cone has a generally flush surface. At the transition 42 between the syringe barrel encapsulating portion 14 and the needle encapsulating portion 12 there is formed a Morse taper 60 as conveniently shown in Figure 3. When the lower end 38c of the syringe barrel 38 comes into contact with Morse taper 60, the IDU is informed that syringe 30 is safely stored within the disposal device Another feature of Morse taper 60 may be observed. Because the lower end 38c of the syringe barrel 38 and needle 33 is safely sealed within Morse taper 60, injectable fluids will not leak back where they may cause harm.

Referring now to Figure 4, there are shown a number of views, each corresponding with a potential possibility for an impact of needle 33 with an inner surface 12a of the syringe disposal device needle encapsulating portion 12 (see Figures 4(c) and an inner surface 14a of the syringe barrel encapsulation portion 14 (Figure or with the apex point 12b of needle encapsulating WO 01/78806 PCT/AU01/00443 14 portion 12 (Figure By experiment, the Applicant has determined that the probability of needle 33 undergoing a destructive impact by impacts of the kind shown in Figures and is about Destruction of needle 33 may occur through a number of possible mechanisms.

The needle 33 may be rendered non-usable by: concertina or collapse such that the land from the tip to the first bend will be too short to enable a vein to be reached; the cross-section of the inner diameter of the needle 33 will be reduced to a point such that the solution will not pass through the needle 33; the tip 33a of needle 33 will be substantially damaged/burred.

Now, the syringe disposal device 12 as above described is a workable embodiment and may be safely used in practice. However, it would be advantageous for the probability of a destructive impact of needle 33 with inner surface 12a of needle encapsulating portion 12 and/or inner surface 14a of syringe barrel encapsulating portion 14 to be substantially increased as this communicates a level of safety and efficacy desirable in the art.

Accordingly, the needle encapsulating portion 12 is redesigned in the syringe disposal device 110 of the present invention. A description of the syringe disposal device 110 of the present invention now follows with reference to Figures 6 to 9.

In general, syringe disposal device 110 accords in design with the syringe disposal device 10 of PCT Patent Application No. PCT/AU00/01204. Therefore, description of the common elements of syringe disposal device 10 and 110 will not be provided here.

Referring to Figure 6, it may be seen that a Morse taper 160 is formed at the interface 142 between syringe barrel encapsulating portion 114 and needle encapsulating portion 112 shown here to be frusto-conical design though that is not essential. This Morse taper 160 corresponds in intention and design with Morse tape 60 of syringe disposal device 10, as above disclosed. Specifically, the taper 160 neatly accommodates the bottom end 38a of syringe barrel 38.

WO 01/78806 PCT/AU01/00443 Distinct from Morse taper 60 is the stepped configuration of the inner surface 112a of needle encapsulating portion 112. This stepped configuration may be distinguished from the smooth inner surface 12a of needle encapsulating portion 12 as shown in Figure 4. A number of steps 112b are shown by way of illustration. The probability of needle 33 undergoing a destructive impact increases generally with the number of steps. It may be seen from Figure 6 that four or five steps may be provided. A greater number could be provided, if desired, subject to manufacturing cost and efficiency considerations. The length of each step may be equal but it may be seen from the drawing that there is some variation in step length between the steps 112b and it is possible that the selected length may also impact on the probability of needle destruction.

A further feature of needle encapsulating portion 112 may be noted. The needle encapsulating portion 112 has a truncated cone portion 112b and a contiguous cylindrical portion 112c, the needle tip 33a potentially being located in recess 112ca of cylindrical portion 112c.

Referring now to Figure 7, there are shown a number of possibilities for destructive impact of needle 33 with both Morse taper 160 and steps 112b formed in the inner surface 112a of needle encapsulating portion 112 of syringe disposal device 110. It has been determined by experiment that the probability of needle 33 undergoing a destructive impact with syringe disposal device 110, as described above, exceeds 90%, approximately 92%.

It may be noted that the earlier the impact of needle 33 occurs with a step 112b, that is, as shown in Figures 7(c) and relative to Figures 7(a) and the greater the probability that needle 33 has passed its maximum destruction force before syringe flange 138a abuts its final position in syringe disposal device 110 and the bottom 138c of syringe barrel 138 locates its final position in Morse taper 160 as shown in Figure 8. In that position, as shown also more clearly in the detail of Figure 9, the needle 33 has buckled, is destroyed and retained without practical possibility of re-use.

When resistance is met earlier in the retention process, a longer duration of resistance occurs thus reducing the maximum resistance required to cause needle destruction.

WO 01/78806 PCT/AU01/00443 16 Referring once again to Figure it may be noted that the greater the axial distance or spacing between syringe 30 and disposal device 10, the greater the bending moment or angular compressive force placed on needle 33. This reduces the force required to destroy/concertina the needle 33 (once again Figures 8 and 9 may be referred to) or the perceived force to insert the used syringe 30 into the disposal device Through application of the various aspects of the invention, a greater probability of needle 33 destruction may be assured, thus increasing the safety and efficacy of syringe disposal device 110. The disposal device 110 may furthermore be readily used in the convenient holder or fitkit of PCT Patent Application No. PCT/AU0/01204.

Referring to Figure 10, there is shown the syringe disposal device 310 of the present invention fabricated from a rigid polymeric material. The syringe disposal device 310 includes a needle encapsulating portion 312, a syringe barrel encapsulating portion 314 and a syringe retention portion 316. The plunger retention portion 316 has a tapered internal wall 317 and it will be observed that said syringe retention portion 316 has greater diameter along substantially its whole length than an outer diameter of the syringe barrel encapsulating portion 314 and needle encapsulating portion 312.

The disposal device 310 is suitable for disposing of any kind of syringe.

The syringe 330 shown in Figure 10 and the drawings generally is of a conventional type having a needle 333, a hub 334, a needle carrier 335, a barrel 338 and a plunger 339. The barrel 338 has transversely extending flange portions 338a which, on engagement with the flange engaging means 320, retain the syringe 330 within disposal device 310.

The syringe retention portion 316 has an open end 311 to allow syringe 330 to be placed by pressing into the device 310. Particularly, it is of sufficient lateral dimension to amply accommodate barrel 338 flanges 338a at open end 311, thus assisting with location. At another opposed end 319, retention portion 316 communicates with the syringe barrel encapsulating portion 314. The opposed end 319, of circular or oval shape, is provided with flange engagement WO 01/78806 PCT/AU01/00443 17 means 320 retaining a syringe 330 within the disposal device 310 after passage of a flange portions 338a past engaging means 320 by interference fitting.

In fulfilling the additional function as a means of transport of an unused syringe there is also provided a cap 321 which covers the plunger 339 of the syringe 330 and is affixed to the device 310. In this instance the cap 321 provides a means to keep dust and other material away from the syringe 330 and also prevent the syringe 330 from unintentionally falling away from the disposal device 310 during transport. In this aspect of the invention the cap 321 is merely press fitted to the device 310 or any other means whereby the cap 321 may be replaced by a user. Once the cap 321 is removed from the device 310 it is expected that the cap 321 will be discarded by the user particularly if it no longer fulfills any useful purpose following use of syringe 330. Therefore, the cap 321 is expected to be disposed of once the used syringe is irretrievably engaged with the disposal device 310. It should be appreciated however, that in this aspect of the invention because the cap 321 is press fitted to the device 310, it may be possible but not preferable that the cap 321 is re-fitted to the device 310 and thus a potential subsequent user may not realise that a syringe 330 within the device 310, but not irretrievably engaged therein, has been used.

Figure 11 shows a preferred embodiment of the invention wherein the cap 321 of Figure 10 is replaced by an integrally connected cap 322. The major difference between the caps 321 and 322 is that cap 322 is attached to the device 310 through detachment means 323 forming a sub-portion of disposal device 310 proximate the openable end. Thus, in this preferred embodiment, the cap 322 must be removed in order for a user to extract the unused syringe 330 but because of the detachment means 323 being irreversibly deformed or damaged it becomes impossible for the cap 322 to be replaced. Therefore, if a user who having used the syringe 330, replaces the used syringe 330 within the device 310 but does not irretrievably engage the syringe 330 within the device 310 any potential subsequent user can infer that the syringe 330 is unsafe to be used because of the removal of the cap 322.

Figures 12a, 12b and 12c show different embodiments of the detachment means 323. Figure 12a indicates a thinned section 324 integrally connecting the WO 01/78806 PCT/AU01/00443 18 cap 322 and syringe retention portion 316. Thus the thinned section 324 defines a line of weakness between the cap 322 and the portion 316. On application of a force by a user to cap 322 that exceeds the breakage force for the thinned section 324, the cap 322 is irreversibly detached from the syringe retention portion 316.

An alternative embodiment of the detachment means 323 is indicated in Figure 12b which shows a direct connection between the cap 322 and the syringe retention portion 316. Connection is made on the vertical faces of the aforementioned elements 322 and 316.

In a further alternative arrangement of the detachment means 323 direct connection 326 is made between the cap 322 and the syringe retention portion 316 such that the connection 326 is made between horizontal faces of the aforementioned members 322 and 316.

It will be appreciated by a person skilled in the art that the embodiments shown in Figures 12a, 12b and 12c merely represent illustration of connection means that may be used in accordance with this aspect of the invention. It should also be appreciated that the embodiments of Figures 12a, 12b and 12c define a continuous line of weakness for the detachment means 323.

Figures 13a and 13b provide for an alternative means of the detachment means 323 in that the line of weakness is interspersed with projections 327 of the syringe retention portion 316 so as to overlap the line of weakness. Providing Projections 327 of the syringe retention portion 316 provide further means for protecting of the device 310.

In the case where a force 329 is applied to the cap 322 in a line orthogonal to the longitudinal axis 328 of the device 310, the device 310 in an unreinforced arrangement, as is the case with Figs 12a, 12b and 12c will fail along a line of weakness 323. If, however, there are provided projections 327 extending parallel to the longitudinal axis 328, these will act to reinforce the device, about its line of weakness 323, through the projections 327 contacting the wall of the device 310.

On application of a torsional load 330, however, the projections 327 do not contact the wall of the device 310, and so cannot assist in preventing failure.

Hence, the addition of the projections 327 tend to hinder opening of the device WO 01/78806 PCT/AU01/00443 19 310 through flexing the cap 310, but do not hinder the twisting off of the cap 310 through application of a torsional load. As accidental opening is more likely to occur through flexing of the cap 310, the use of the projections 327 will minimise the chance of accidental opening of the device 310.

Referring to Figure 14, there is shown a holder 500 containing a syringe disposal device 410 and syringe 430 as described in PCT Patent Application No PCT/AU00/01204, "Syringe Disposal Device", priority date 30 September 1999, the contents of which were previously incorporated herein by reference.

Accordingly, no further description of the device 410 will be made herein.

Disposal devices of other kinds may be used in though use of the Applicant's disposal device gives particular advantages in terms of safe needle disposal.

Holder 500 contains suitable items for an injection event in its thermoformed or injection moulded base 510 which neatly accommodates syringe disposal device 410.

Ordinarily, and for legal reasons in most jurisdictions, the holder 500 will not contain the injectable but this may be provided if desired and permitted by law. The holder 500 could also include a receptacle, especially a spoon, for mixing the injectable with distilled water prior to injection. However, the spoonwhich could be formed into holder 500-is excluded from the drawing. Holder 500 could also contain distilled water and filters. The holder 500 may be packaged to be sterile prior to opening by the IDU and, in this way, the injection event may be made as safe as possible. It is most advantageous that the holder 500 accommodate a single syringe 430 as it is most likely that this will be the preferred capacity of needle exchanges for legal reasons. In any event, holders 500 may be disposed of as desired by the IDU but could be collected in a central disposal area. A condition of needle exchange may be return of the holders 500.

If the device is properly used, the public health risk posed by use of syringes is much reduced.

Holder 500 may be wrapped with a removable wrapper which may be transparent. Such a wrapper could be a suitable plastic film. A reclosable lid could be provided which may also be transparent.

WO 01/78806 PCT/AU01/00443 Referring now to Figures 15 and 16, there is shown a receptacle 420, of the kind that could be provided as above described, and having a wall 421 defining a vessel 422 in which an injectable solution may be prepared. The wall 421 has a generally concave profile. Proximate maximum depth of vessel 422, and symmetrically disposed about central axis 422a of vessel 422, is provided a depression 424 which forms a sump for solutions contained within vessel 422.

The shape of the depression 424 is not particularly important, though it could be hemi- or part-spherical, and its maximum width and depth would be a few millimetres. If the depression 424 is circular in plan it is the diameter of that depression 424 that would be a few millimetres, say 2mm, or a dimension that easily accommodates the needle with which it is used. The wall of depression 424 may be discontinuous with defining wall 421 in that the transition between them is not smooth. The shape of depression 424 and vessel 422 may be the same or different.

The depression 424 could be located elsewhere than centrally of the vessel 422 but location at maximum depth facilitates the drawing up process without injectable loss.

Vessel 422 may be provided with a handle portion 426 formed by a continuation of wall 421. The handle portion may have a bend or radiussed portion and handle designs of the kind applied to cups may generally be used.

At the opposite side of vessel 422, wall 421 is contoured to form a rim portion 427 which may be of a tubular or other section extending down from the rim or from wall 421. Rim portion 427 is provided with a groove 427a proximate the distal end 427b. The rim portion 427 need not extend about the periphery of the vessel 422. Rather a number of rim portions or tongues 427 may be spaced about the periphery of vessel 422.

The receptacle 420, as can be seen from the above description is spoonlike. Receptacle 420 may therefore be referred to as a spoon. Spoon 420 may be made of any suitable material, plastics or metal (non-toxic) being particularly suitable. The material selected shall take account of possible heating of vessel 422 to prepare injectable solution.

WO 01/78806 PCT/AU01/00443 21 A spoon 420, as described above, may be connected to holder 1100 which takes the form of a box having walls 1120 defining a receptacle in which syringe disposal device 410 may be located. Holder 1100 and spoon 420 may be connected together by cooperating engagement means. A portion of syringe disposal device 410 together with portion of holder 1100 and walls 1120 is shown in Figures 17 and 18. An end wall 1121 is formed with a rib 1122 at such location as to easily cooperate with groove 427a of spoon 420. Figures 17 and 18 show the assembly of spoon 420 and holder 1100. Basically, the user can readily snap fit rim portion 427 over end wall 1121 by cooperation between rib 1122 and groove 427a thus securing holder 1100 and spoon 420 together. The plurality of rim portions 427 may allow connection of spoon 420 and holder 500 in a number of orientations but generally facilitating securement. Such rim portions 427 may also form flame guards.

The rib 1122 may also be formed in such a manner as to facilitate such securement. Similar ribs 1122 could be located on other walls of holder 1100. It will be understood that ribs and grooves may be juxtaposed, or inverted in position, if desired. It will further be understood that a spoon, not having a sump as above described, may equally be secured to the holder 1100 by this means.

That constitutes a further aspect of the present invention. The spoon/holder assembly 1200 may be wrapped in a suitable packaging material, perhaps of the kind above described. Other assemblies or configurations are not excluded.

A further embodiment of the spoon or receptacle of the present invention is shown in Figures 19 to 21 of the drawings. Spoon 520 is generally of the same construction as above described. However, handle 526 incorporates a pinch grip 528. Such a pinch grip 528 may provide greater stability. The spoon 520 incorporates a flame guard 529 comprising a barrier wall that protects the fingers of the IDU from the naked flame commonly used to mix non-water soluble products and, to that extent, has an advantage over the handle 426 described above in reference to Figures 15 to 18.

Referring to bottom perspective view, Figure 21, the sump 524 may be seen to be formed by a semi-spherical protrusion or dimple from the wall 522 forming the receptacle or vessel of spoon 520.

WO 01/78806 PCT/AU01/00443 22 The spoon 520 of Figures 19 to 21 may readily be stored in a holder 1100 as shown in Figures 22 and 23 which show both operative and stored positions of spoon 520. In a stored position, it may be seen that spoon 520 is inverted and stored within compartment 1140. The dimensions of spoon 520 and compartment 540 are such that the spoon 520 fits neatly therein and will not readily be shaken loose during transport. In use, spoon 520 may be clipped to end wall 521 in an operative position in similar manner to that described with reference to Figures 17 and 18.

Referring now to Figures 24 and 25, description will be made of spoon 520 of Figures 19 to 21 when in use. During an injection event, an IDU may mix injectable with distilled water or other solvent to form an injectable solution.

Where a naked flame is used, flame guard 529 protects the IDU from finger burns due to exposure to naked flame commonly used to heat the solution to ease injectable dissolution. Such injectable solution is then drawn up into the syringe 430. By location of the needle 438 within sump 524, the needle 438 is securely positioned and erratic movements that could cause needle damage may be minimised. As injectable solution drains to sump 524 during the drawing up operation, solution loss is also minimised. Both features encourage use of the device and kit by an IDU.

Needle damage and injection safety may still further be enhanced by locating a filter 440 within sump 524. The filter 440 particularly prevents solid matter entering the syringe. Filter 440 may be a medically acceptable, sterile liquid absorbent material, for example a cotton ball or cotton pellet. The ball or pellet may be pre-fitted in sump 524 or may be fitted therein by the IDU. The former may be more advantageous because appropriate fitting of filter 440 into a sump 524 of small diameter may be a difficult job.

Referring firstly to Figures 27a to 27e, in this case the receptacle or spoon 620 having sump 624, is moulded into the external base 2160 of syringe holder 2100 proximate the end wall 2121. On the opposite side of receptacle or spoon 620 is located a partition wall 2110 having a socket 2112 into which a syringe retaining/disposal device (not shown) may be located. In such an embodiment, WO 01/78806 PCT/AU01/00443 23 the IDU simply turns the syringe holder 2100 over to prepare the injectable solution.

In a still further embodiment shown in Figures 28a to 28c the receptacle or spoon 720 having sump 724, is shown moulded into the internal base 3160 or syringe holder 3100 proximate the end wall 3121. On the opposite side of receptacle 720 is located a partition wall 3110 having a socket 3112 into which a syringe retaining/disposal device (not shown) may be located.

In a further embodiment, as shown in Figure 26, holder 1100 is provided on its base 1160 with two locating grooves 1165a and 1165b. The dimensions of grooves 1165a and 1165b are selected to allow rim portion 627 and handle 626 to respectively snap into them. Other means of connection may be used allowing the holder 1100 to act as a more stable platform for preparation of an injection.

Such forms of connection may conveniently be located on the base 1160 of holder 1100.

In still further modifications, as will be explained with reference to Figures 27a to 27e and Figures 28a to 28c, the spoon or receptacle may be moulded into either of the internal or external base of syringe holder 2100.

Modifications and variations may be made to the syringe retaining device or receptacle and kit or holder of the present invention after reading of the disclosure by the skilled reader. Such modifications and variations are intended to form part of the present invention.

Claims (13)

1. A syringe retaining device for encapsulating a syringe and a needle attached thereto including an elongate tube openable at one end for insertion of the syringe, and closed at an opposing closed end wherein at least one step is provided on an inside surface of the device intermediate said closed and openable ends to contact and cause damage to the needle such that the spacing of the step to the closed end is determined by maximising the probability of damage to the needle through applying the insertion force.

2. The device according to claim 1 wherein the step is spaced proximate the closed end.

3. The device according to any one of claims 1 or 2, wherein a plurality of steps are provided on the inside surface.

4. The device according to claim 3, wherein said syringe retaining device has a syringe barrel encapsulating portion and a needle encapsulating portion and said inside surface forms part of at least one of said syringe barrel encapsulating portion and said needle encapsulating portion.

The device according to claim 3 or 4, wherein there are at least four steps.

6. The device according to claim 4 or 5, wherein at least one step is located adjacent an interface between said syringe barrel encapsulating portion and said needle encapsulating portion.

7. A syringe retaining device for encapsulating a syringe, having a needle, a barrel, a plunger and, on the barrel or plunger, a transversely extending flange, said device including a syringe retention portion having a flange engaging means which engages said flange to retain said syringe in said device, a needle AMENDED SHEEf IPEA/AU \O c encapsulating portion with a barrel encapsulating portion intermediate said syringe retention portion and needle encapsulating portions, wherein at least one oO step is provided on an inside surface of the device wherein said step is provided on an inner surface of the device to contact and cause damage to the needle, as force is applied to the syringe during insertion.

8. The device according to claim 7, wherein said at least step is arranged on c an inner surface of at least one of said syringe barrel encapsulating portion and C)said needle encapsulating portion.

9. The device according to claim 8 wherein the spacing of the step to closed end of said needle encapsulating portion is determined by maximising the probability of damage to the needle through applying the insertion force.

The device according to any one of claims 7 to 9 wherein a plurality of steps are provided on the inside surface.

11. The device according to claim 10, wherein there are at least four steps.

12. The device according to any one of claims 8 to 11, wherein said at least one step is located adjacent an interface between said syringe barrel encapsulating portions and said needle encapsulating portion.

13. A syringe retaining device substantially as hereinbefore described with reference to the drawings. DATED this 27th day of June 2006 BASKE PTY LTD WATERMARK PATENT TRADE MARK ATTORNEYS GPO BOX 2512 PERTH WA 6001 AUSTRALIA P16950AUPC