WO2005004957A1 - Improved syringe safety device - Google Patents

Improved syringe safety device Download PDF

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Publication number
WO2005004957A1
WO2005004957A1 PCT/AU2004/000952 AU2004000952W WO2005004957A1 WO 2005004957 A1 WO2005004957 A1 WO 2005004957A1 AU 2004000952 W AU2004000952 W AU 2004000952W WO 2005004957 A1 WO2005004957 A1 WO 2005004957A1
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WO
WIPO (PCT)
Prior art keywords
syringe
needle
barrel
encapsulating
resilient member
Prior art date
Application number
PCT/AU2004/000952
Other languages
French (fr)
Inventor
Mario Guiseppe Sticca
Original Assignee
Caretech Group Pty Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Caretech Group Pty Ltd filed Critical Caretech Group Pty Ltd
Publication of WO2005004957A1 publication Critical patent/WO2005004957A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles

Definitions

  • the present invention relates to a syringe safety device and, in particular, to a device suitable for safe retention of a single syringe.
  • a health problem arises through the hazards of used needles, for example, a number of diseases may be transmitted by intentional reuse of syringes. 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.
  • 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 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.
  • That syringe disposal device is described in Australian Patent Application No.78896/00. 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 needle- encapsulating 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.
  • a further problem has been identified with the syringe disposal device in that there is a risk that a needle could penetrate the needle encapsulating portion at the (closed) end of the device. For example, if the needle extends too far to be safely accommodated within the device, or if the wrong type of syringe is used with the device thereby risking penetration by even a short needle.
  • SUMMARY OF THE INVENTION With this in mind, it is an object of the present invention to provide a syringe safety device for safely retaining syringes of various types. It is a secondary object of the present invention to provide a syringe safety device having a reduced risk of needle penetration.
  • the present invention provides in a first aspect a syringe safety device for a syringe including a barrel and plunger, wherein the barrel includes a projecting portion for engagement with the safety device, the safety device including a needle encapsulating portion, a syringe barrel encapsulating portion, and a syringe retention portion, said syringe retention portion including; (a) an open end for insertion therein of a syringe; (b) an opposed end communicating said retention portion with said syringe barrel encapsulating portion; (c) a body extending between the open and opposed ends including a resilient member and an engagement means for retaining the syringe; wherein the resilient member is flexed by the projecting portion to permit passage of the syringe into the device and subsequent engagement with the engaging means to retain the syringe within the device.
  • the resilient member and engaging means of the retention portion act together to permit the safety device to receive and retain a syringe of more than one size.
  • the resilient portions may further help to reduce breakage of the device when an oversize syringe is otherwise inserted therein.
  • the safety device includes two or more resilient members.
  • each resilient member and engaging means may be together in one retaining means or separate as individual engaging means and resilient members.
  • the syringe retention portion may advantageously have engaging means in the form of projections, for example, one or more lugs or ridges. These may include inclined (ramp) portions allowing the syringe projecting portion to gradually increase pressure against the resilient member during insertion of the syringe thereby gradually flexing away the resilient member to permit passage of the syringe into the device.
  • the body of the retention portion may have one or more side walls tapered with respect to the syringe such that the apparent width of the opening decreases as the syringe is inserted and the resilient member is a portion of at least one wall of the body which flexes to allow passage of the syringe projecting portion.
  • each resilient member is formed in the body of the retention portion by providing slots in at least one of the walls thereof, the slots defining therebetween at least one resilient member.
  • the slots may extend from the opposed end of the retention portion part way along the at least one wall towards the open end of the retention portion. Alternatively or in addition, the slots may extend from the open end towards the opposed end.
  • the syringe retention portion may have greater external dimension along substantially its whole length than an outer diameter of the syringe barrel encapsulating portion and the needle encapsulating portion. Engagement means additional to those provided in the syringe retention portion may be provided as described, for example, below.
  • the syringe safety device is constructed to receive and retain a syringe wherein the projecting portion of the barrel is a transverse extending portion or flange.
  • the device is provided with retaining means to retain a syringe having more than one such transverse extending portion or flange.
  • the transversely extending portion or flange may be constituted by a syringe barrel outer surface or a surface of a transversely extending portion of a flange of the plunger or syringe barrel or both. It will ordinarily be constituted by the broadest portion of the disposed syringe thus bearing on the engaging means to prevent syringe retraction by exertion of reasonable force after use.
  • the transverse extending portions or flanges may be the finger grip extensions of a syringe barrel which help support and steady a syringe during use as the plunger is forced into the barrel.
  • a number of lug engagement means may be provided for engaging the transversely extending bearing portion.
  • the engaging means may include one or more channels or apertures in the body of the retention portion.
  • each resilient member flexes to effectively increase the width of the body and permit passage of the syringe and thereafter each projecting portion of the syringe engages with the channels or apertures in the body to retain the syringe.
  • each resilient member at least partially returns to an unflexed (pre syringe insertion) position.
  • the flanges etc may extend beyond the exterior dimensions of the retention portion through the aperture(s) once retained by the engaging means, thereby giving a visual indication that the syringe is "locked” into a retained position.
  • a suitable polymer is preferably to be used forming the device, noting that such polymer should have nature requisite to, and fabricated for preventing needle puncture but resiliently flexible enough to form the retaining means.
  • the safety device may incorporate a tapered element, particularly at the transition between the syringe barrel encapsulating portion and the needle encapsulating portion or a protective cap portion. This tapered element accommodates the needle carrier, hub, needle and/or upper end of the syringe barrel in a neat engaging fit similar to that employed for fitting of sockets and the like in tool kits.
  • the tapered element may be formed integral of the device or as a separate element and subsequently added e.g. by press or clip fit.
  • the tapered element may form part of the barrel encapsulating or needle encapsulating portions.
  • the safety device may be constructed such that at least one of the needle encapsulating portion and the syringe barrel encapsulating portion have a multi- stepped configuration for increasing the probability of the needle impacting the inner surface during retaining of a syringe.
  • the syringe safety device is suitable for holding a syringe following an injection event, especially in a therapeutic environment.
  • a method of retaining a syringe in a syringe safety device including the steps of; (a) inserting a syringe having a barrel with a portion extending thereof and a plunger into the syringe safety device (b) flexing the resilient portion by contact of the extending portion to permit passage of the syringe (c) engaging and retaining the extending portion to retain the syringe within the device.
  • a syringe safety device for a syringe having a barrel and a needle
  • the device including; (a) a syringe barrel encapsulating portion; and (b) a protective cap; wherein, the protective cap is of sufficiently hard material to prevent the tip of a syringe needle inserted into the device from penetrating through from the interior to the exterior of the device.
  • the protective cap is of sufficiently hard material to prevent the tip of a syringe needle inserted into the device from penetrating through from the interior to the exterior of the device.
  • the device may include a needle encapsulating portion connected at one end of the barrel encapsulating portion and in communication therewith for receiving the syringe needle.
  • the needle encapsulating portion may fully or partially close off the end of the barrel encapsulating portion.
  • the protective cap may cover the needle encapsulating portion to reduce or prevent needle penetration through to the exterior of the device and thus alleviating the risk of occurrence of 'needle stick' injuries.
  • the protective cap may also form the needle encapsulating portion.
  • the device may include an insert portion which can be inserted into and engage with the interior of the barrel encapsulating portion to form the needle encapsulating portion and/or seating means for an end of a syringe barrel placed in the device.
  • the protective cap can be formed separately of the remainder of the device and subsequently fitted to cover the end of the barrel encapsulating portion and/or needle encapsulating portion as appropriate.
  • at least a two part structure (or three part structure with the separate insert portion) to the device is envisaged.
  • the protective cap may be connected to the barrel encapsulating portion and/or the needle encapsulating portion by adhesive or mechanical connection means such as an inter-cooperating ridge and groove, or clip or snap fit means. Connection may be temporary i.e. the cap may be removed when desired or permanent e.g. only removed by destruction of the device.
  • the protective cap may be advantageously formed of any chosen material suitable for the purpose i.e.
  • the protective cap may be conveniently formed integral of the device during construction thereof, for example, by co-extrusion. It can be envisaged that the protective cap and barrel/needle encapsulating portions are of differing materials, for example, the protective cap may be of a rigid thermosetting plastic and the barrel or needle encapsulating portions of a less rigid thermoplastic.
  • Mechanical connection means preferably includes at least one engagement means e.g. a ridge or groove on one or both of the needle encapsulating portion or barrel encapsulating portion with at least one corresponding engagement means e.g.
  • Engagement means may be provided on an external surface of the needle or barrel encapsulating portions or the protective cap, with a corresponding at least one ridge or groove interconnecting therewith on the other of the external surface of the needle or barrel encapsulating portions or protective cap.
  • the ridge and groove connection means may be a once only i.e. non removable, fit.
  • Each groove may be annular groove formed on an interior surface of a dome shaped protective cap for interconnection with a corresponding ridge on the exterior surface of the needle encapsulating portion, or vice versa.
  • Each groove may include a bevel of preferably 45°.
  • the protective cap is a taper fit to the needle encapsulating portion for retention thereof. It is envisaged that the protective cap may cover substantially all of the needle encapsulating portion, thus alleviating the risk of penetration by a bent or curved needle. Preferably the protective cap additionally covers shoulder portions of the syringe barrel encapsulating portion formed proximate the juncture of the barrel encapsulating portion and needle encapsulating portion.
  • Figure 3 shows an external side view of the syringe safety device according to Figure 1.
  • Figure 4 shows a partial sectional view of the syringe safety device during insertion of the syringe therein.
  • Figure 5 shows a similar partial sectional view as shown in Figure 4 with the syringe retained by the engaging means.
  • Figures 6a-6d show sectional views of a syringe safety device according to alternative embodiments of the present invention.
  • Figures 6b-d show various embodiments of the protective cap on the needle encapsulating portion.
  • Figure 7 shows an end section of the syringe safety device according to the present invention with a protective cap.
  • Figure 8 shows a partial sectional view of an alternative embodiment of the syringe safety device of the present invention including a protective cap connected to an end of a syringe barrel encapsulating portion of the device.
  • Figure 9 shows a partial sectional view of the an alternative arrangement of the embodiment according to Figure 8.
  • FIG. 1 there is shown a syringe safety device 10 according to a preferred embodiment of the present invention.
  • the syringe safety device 10 of the present invention fabricated from a rigid polymeric material.
  • the syringe safety device 10 includes a needle encapsulating portion 12, a syringe barrel encapsulating portion 14 and a syringe retention portion 16. It will be observed that the retention portion 16 has a greater width along substantially its whole length than an outer diameter of the syringe barrel encapsulating portion 14 or needle encapsulating portion 12.
  • the retention portion is sufficiently wide to accommodate the transversely extending portions (flanges) of a syringe barrel.
  • the syringe safety device 10 is suitable for safely containing and/or transporting or disposing of typical syringes used for injecting, for example, intravenously or subcutaneously.
  • the syringe retention portion 16 has an open end 18 to allow a syringe to be placed by insertion into the device 10. Particularly, the opening is of sufficient lateral dimension to amply accommodate the barrel and flanges, thus assisting with location.
  • retention portion 16 communicates with the syringe barrel encapsulating portion 14.
  • the body 15 of the retention portion 16 extends between the open end 18 and opposed end 19.
  • the body 15 is provided with engagement means 20 (not shown) internal thereof for retaining a syringe within the disposal device 10 after passage of flange portions past engaging means 20.
  • the retention portion 16 further includes slots 21 a, 21 b and 22a, 22b. Slot 21a corresponds with slot 21 b on the reverse side of the body 15, and similarly, slot 22a corresponds with slot 22b. Slots 21a and 22b permit a member 23 of the body 15 of the retention portion 16 to resiliently flex and thus allow the flange to pass the engaging means during insertion of a syringe into the device 10. The engaging means thereafter returns or partially returns to its original position to retain the flange. Thus the syringe is prevented from being readily removed from the device.
  • slots 22a and 22b permit a further member 24 of the body 15 to resiliently flex during insertion of a syringe into the device.
  • the retention device 10 may include one or more such resilient members 23, 24.
  • the syringe may include a cap over the plunger to prevent insertion of the syringe into the disposal device until the cap is removed. Thus the flanges are prevented from engagement with the engaging means until the cap is removed from the plunger and, following use, the syringe is ready to be retained in the device. Other arrangements to prevent this result are however possible.
  • Figure 2 shows a longitudinal sectional view of the device 10 of Figure 1. Slots 21 b and 22b are shown in the section.
  • Engaging means 20a, 20b are shown on corresponding body portions 23, 24. According to the embodiment shown, the engaging means 20a, 20b are integral with the body 15 as wedge shaped projections. As shown, the device may include one or more webs 25. These webs may act to guide the flanges of a syringe during insertion and to restrict lateral movement of the syringe within the device by contact with the flanges once retained in position. However, it will be appreciated that the device need not include these webs and a close or interference fit of the body with the syringe may alternatively restrict movement of the syringe.
  • the slots 21b, 22b (and 21 a, 22a) are shown having rounded inboard ends.
  • Such rounded ends help prevent the slots enlarging due to weakening of the material of the device and in addition aid flexure of the body portions 23, 24 during insertion of a syringe.
  • the slots need not be limited to this particular shape and that other arrangements are envisaged.
  • generally triangular ends or simple regular elongate slots may be provided.
  • the slots include rounded ends so as to reduce the risk of fracture of the material of the retention portion 16 at the stress point caused by flexure of the material. It is not necessary that it be the transversely extending flange portion of the syringe that passes the engaging means.
  • Another portion of the syringe may alternatively or additionally be engaged and this may be necessary for syringes of other design.
  • other forms of engaging means may be contemplated by the present invention.
  • one or more channels or apertures in the body may be provided.
  • a visual indication that the syringe is retained or "locked” in position for disposal may be given by one or more portions of the barrel extending through or be visible through said apertures.
  • the device 10 is conveniently manufactured from a polymeric material.
  • the device 10 may be used for all conventional designs of syringe as, in this way, efficacy of retention device 10 will be best promoted.
  • the slots 21a, 22a are shown as corresponding, that is, directly overlying in plan view, the associated slots 21 b, 22b on the reverse of the device 10.
  • the paired slots 21a, 21 b and 22a, 22b define the retaining means including the engagement means 20a,20b of the device.
  • a syringe 30 is shown in a position during insertion in the direction of arrow 'A'.
  • the syringe includes a barrel 31 , a plunger 32 and transverse extending portions or flanges 33a,33b.
  • the retention portion 16 includes retaining means in the form of a resilient member 23, 24 having at least one projection or lug 20a, 20b extending towards the syringe from two sides of the device.
  • the engaging means include, in the embodiment, inclined portions or ramps 26a, 27a.
  • each flange 33a,33b contacts a corresponding ramp 26a, 27a which causes the respective resilient member 23, 24 to flex away from the syringe due to the narrower width of the syringe at that portion than the retention portion 16.
  • Slots 22a, 22b (and corresponding slots 21a, 22a) permit flexure of the resilient members formed integral of side walls of the body 15 of the retention portion 16.
  • Strengthening ribs 25 reduce excess flexure of the retention portion 16 and help to prevent excess sideways movement of the syringe once retained in position.
  • Figure 5 shows a similar partial sectional view as shown in Figure 4, however, the syringe 30 is shown in a retained or locked position subsequent to insertion into the device 10.
  • the projections 20a, 20b are resiliently returned to an un-flexed position following passage of the flanges 33a, 33b therepast.
  • the slots 21 b, 22b (and correspondingly 21a, 22a) are seen in an un-widened attitude due to the substantial removal of flexural stresses at the rounded inboard ends 28a, 28b.
  • the resilient members 23, 24 may remain at least partly flexed so long as the syringe is safely retained in position by the engaging means 20a, 20b.
  • the needle encapsulating portion 12 is formed of material sufficiently rigid and/or dense to avoid the possibility of needle puncturing it. Polymeric materials may be selected to achieve this purpose as described above.
  • the device 10 includes a syringe retention portion for retaining a syringe inserted into the device, with the syringe barrel including a projecting portion for engagement with the retention portion of the device.
  • Figures 6b-6d show sectional views of further embodiments according to the present invention.
  • Figure 6b shows the syringe safety device 10 with a protective cap 40.
  • the cap 40 entirely covers the needle encapsulating portion 12 and includes a shoulder cover portion 41 covering a shoulder formed on the device at the juncture between the needle encapsulating portion 12 and the barrel encapsulating portion 14.
  • An alternative embodiment shown in Figure 6c extends to meet the shoulder 42 but does not include the shoulder cover portion 41.
  • Figure 6d shows a further embodiment of the protective cover 40 with thickened side wall 43 which extends to cover the shoulder 42 without a shoulder cover portion 41.
  • the protective cap may be formed integrally with the device or separately and connected or joined as required. Connection may be by mechanical means, for example, interconnecting ridge and groove means or adhesive. Alternatively a taper or interference fit is envisaged.
  • Figure 7 there is shown an end portion of the device 10 with the protective cap 40.
  • the cap 40 includes in this embodiment an annular groove 50, which may, as shown, have a 45° bevel 51 , for interconnection with a corresponding ridge 52 on the needle encapsulating portion 12.
  • the device 10 includes a protective cap 60 connected to an end of a barrel encapsulating portion 61.
  • the protective cap 60 shown also forms the needle encapsulating portion. However, it will be appreciated that the protective cap 60 may be provided in addition to a separate needle encapsulating portion.
  • An end 62 of the barrel encapsulating portion 61 includes a stepped or cutaway portion 63.
  • the protective cap includes a corresponding stepped or cutaway portion 64 for engagement with the corresponding stepped portion of the barrel encapsulating portion.
  • the connection may be by interference fit, adhesive means, and/or other suitable connection means, for example, inter-engaging ridge and groove means 65, 66 such as depicted in Figure 9.
  • the stepping may be reversed such that the protective cap inserts fits into and engages with an inner surface 67 of the barrel encapsulating portion.
  • the protective cap is preferably of a harder material than that of the remainder of the device, though may be of the same hardness provided that the material prevents puncture of the cap by a syringe needle.

Abstract

A syringe disposal device (10) including a needle encapsulating portion (12), a syringe barrel encapsulating portion (14), and a syringe retention portion (16), the syringe retention portion having an open end (18) for insertion therein of a syringe, an opposed end (19) communicating said retention portion with said syringe barrel encapsulating portion, a body (15) extending between the open and opposed ends including at least one resilient member (23) and an engagement means (20), preferably projections eg lugs or ridges, for retaining the syringe. The resilient member is flexed by the syringe to permit passage thereof into the device and subsequent engagement with the engaging means to retain the syringe within the device.

Description

IMPROVED SYRINGE SAFETY DEVICE FIELD OF THE INVENTION The present invention relates to a syringe safety device and, in particular, to a device suitable for safe retention of a single syringe. BACKGROUND OF THE INVENTION It is well recognised that many substances are commonly administered intravenously. Accordingly, a health problem arises through the hazards of used needles, for example, a number of diseases may be transmitted by intentional reuse of syringes. 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 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 intravenous drug users (IDU). 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 indicated that a major problem with needle syringe exchange programs is availability of disposal units on both a locality and time frame basis. A syringe disposal device that addressed the problems described above at reasonable cost and accessibility to the IDU has been developed. That syringe disposal device is described in Australian Patent Application No.78896/00. 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 needle- encapsulating 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. Although the syringe disposal device has been found efficacious in the disposal of used syringes a problem however remains in that each disposal device is constructed so as to receive and retain a syringe of one particular type. Thus, each disposal device needs to be preformed to particular dimensions to receive and retain the corresponding size of syringe. Furthermore, it is known that breakage of the disposal device can occur when an oversize eg over-wide or miss-sized syringe is attempted to be inserted into the disposal device. A further problem has been identified with the syringe disposal device in that there is a risk that a needle could penetrate the needle encapsulating portion at the (closed) end of the device. For example, if the needle extends too far to be safely accommodated within the device, or if the wrong type of syringe is used with the device thereby risking penetration by even a short needle. SUMMARY OF THE INVENTION With this in mind, it is an object of the present invention to provide a syringe safety device for safely retaining syringes of various types. It is a secondary object of the present invention to provide a syringe safety device having a reduced risk of needle penetration. With the aforementioned in view, the present invention provides in a first aspect a syringe safety device for a syringe including a barrel and plunger, wherein the barrel includes a projecting portion for engagement with the safety device, the safety device including a needle encapsulating portion, a syringe barrel encapsulating portion, and a syringe retention portion, said syringe retention portion including; (a) an open end for insertion therein of a syringe; (b) an opposed end communicating said retention portion with said syringe barrel encapsulating portion; (c) a body extending between the open and opposed ends including a resilient member and an engagement means for retaining the syringe; wherein the resilient member is flexed by the projecting portion to permit passage of the syringe into the device and subsequent engagement with the engaging means to retain the syringe within the device. Thus, the resilient member and engaging means of the retention portion act together to permit the safety device to receive and retain a syringe of more than one size. The resilient portions may further help to reduce breakage of the device when an oversize syringe is otherwise inserted therein. Preferably the safety device includes two or more resilient members.
However, it will be appreciated that the device need not require more than one resilient member and that each resilient member and engaging means may be together in one retaining means or separate as individual engaging means and resilient members. The syringe retention portion may advantageously have engaging means in the form of projections, for example, one or more lugs or ridges. These may include inclined (ramp) portions allowing the syringe projecting portion to gradually increase pressure against the resilient member during insertion of the syringe thereby gradually flexing away the resilient member to permit passage of the syringe into the device. Alternatively or in combination it is envisaged that the body of the retention portion may have one or more side walls tapered with respect to the syringe such that the apparent width of the opening decreases as the syringe is inserted and the resilient member is a portion of at least one wall of the body which flexes to allow passage of the syringe projecting portion. Preferably each resilient member is formed in the body of the retention portion by providing slots in at least one of the walls thereof, the slots defining therebetween at least one resilient member. The slots may extend from the opposed end of the retention portion part way along the at least one wall towards the open end of the retention portion. Alternatively or in addition, the slots may extend from the open end towards the opposed end. The syringe retention portion may have greater external dimension along substantially its whole length than an outer diameter of the syringe barrel encapsulating portion and the needle encapsulating portion. Engagement means additional to those provided in the syringe retention portion may be provided as described, for example, below. Preferably the syringe safety device is constructed to receive and retain a syringe wherein the projecting portion of the barrel is a transverse extending portion or flange. Preferably the device is provided with retaining means to retain a syringe having more than one such transverse extending portion or flange. The transversely extending portion or flange may be constituted by a syringe barrel outer surface or a surface of a transversely extending portion of a flange of the plunger or syringe barrel or both. It will ordinarily be constituted by the broadest portion of the disposed syringe thus bearing on the engaging means to prevent syringe retraction by exertion of reasonable force after use. Thus the transverse extending portions or flanges may be the finger grip extensions of a syringe barrel which help support and steady a syringe during use as the plunger is forced into the barrel. A number of lug engagement means may be provided for engaging the transversely extending bearing portion. Alternatively or in addition the engaging means may include one or more channels or apertures in the body of the retention portion. Thus, as the syringe passes into the device each resilient member flexes to effectively increase the width of the body and permit passage of the syringe and thereafter each projecting portion of the syringe engages with the channels or apertures in the body to retain the syringe. On engagement, each resilient member at least partially returns to an unflexed (pre syringe insertion) position. Thus the flanges etc may extend beyond the exterior dimensions of the retention portion through the aperture(s) once retained by the engaging means, thereby giving a visual indication that the syringe is "locked" into a retained position. Preferably a suitable polymer is preferably to be used forming the device, noting that such polymer should have nature requisite to, and fabricated for preventing needle puncture but resiliently flexible enough to form the retaining means. The safety device may incorporate a tapered element, particularly at the transition between the syringe barrel encapsulating portion and the needle encapsulating portion or a protective cap portion. This tapered element accommodates the needle carrier, hub, needle and/or upper end of the syringe barrel in a neat engaging fit similar to that employed for fitting of sockets and the like in tool kits. The tapered element may be formed integral of the device or as a separate element and subsequently added e.g. by press or clip fit. The tapered element may form part of the barrel encapsulating or needle encapsulating portions. The safety device may be constructed such that at least one of the needle encapsulating portion and the syringe barrel encapsulating portion have a multi- stepped configuration for increasing the probability of the needle impacting the inner surface during retaining of a syringe. The syringe safety device is suitable for holding a syringe following an injection event, especially in a therapeutic environment. In a second aspect of the present invention there is provided a method of retaining a syringe in a syringe safety device according to the first aspect of the present invention including the steps of; (a) inserting a syringe having a barrel with a portion extending thereof and a plunger into the syringe safety device (b) flexing the resilient portion by contact of the extending portion to permit passage of the syringe (c) engaging and retaining the extending portion to retain the syringe within the device. According to a further aspect of the present invention there is provided a syringe safety device for a syringe having a barrel and a needle, the device including; (a) a syringe barrel encapsulating portion; and (b) a protective cap; wherein, the protective cap is of sufficiently hard material to prevent the tip of a syringe needle inserted into the device from penetrating through from the interior to the exterior of the device. Thus accidental needle penetration is alleviated by providing a needle proof protective cap. The device may include a needle encapsulating portion connected at one end of the barrel encapsulating portion and in communication therewith for receiving the syringe needle. The needle encapsulating portion may fully or partially close off the end of the barrel encapsulating portion. The protective cap may cover the needle encapsulating portion to reduce or prevent needle penetration through to the exterior of the device and thus alleviating the risk of occurrence of 'needle stick' injuries. Alternatively the protective cap may also form the needle encapsulating portion. In a further embodiment the device may include an insert portion which can be inserted into and engage with the interior of the barrel encapsulating portion to form the needle encapsulating portion and/or seating means for an end of a syringe barrel placed in the device. According to a preferred embodiment the protective cap can be formed separately of the remainder of the device and subsequently fitted to cover the end of the barrel encapsulating portion and/or needle encapsulating portion as appropriate. Thus, according to a further embodiment at least a two part structure (or three part structure with the separate insert portion) to the device is envisaged. The protective cap may be connected to the barrel encapsulating portion and/or the needle encapsulating portion by adhesive or mechanical connection means such as an inter-cooperating ridge and groove, or clip or snap fit means. Connection may be temporary i.e. the cap may be removed when desired or permanent e.g. only removed by destruction of the device. The protective cap may be advantageously formed of any chosen material suitable for the purpose i.e. a metal or dense plastic which can be of a different material from that chosen for the remainder of the device. The material can be harder, for example. According to an alternative embodiment the protective cap may be conveniently formed integral of the device during construction thereof, for example, by co-extrusion. It can be envisaged that the protective cap and barrel/needle encapsulating portions are of differing materials, for example, the protective cap may be of a rigid thermosetting plastic and the barrel or needle encapsulating portions of a less rigid thermoplastic. Mechanical connection means preferably includes at least one engagement means e.g. a ridge or groove on one or both of the needle encapsulating portion or barrel encapsulating portion with at least one corresponding engagement means e.g. groove or ridge provided on the cap such that the protective cap can be connected to the remainder of the device to cover and protect the end thereof from needle puncture. Engagement means may be provided on an external surface of the needle or barrel encapsulating portions or the protective cap, with a corresponding at least one ridge or groove interconnecting therewith on the other of the external surface of the needle or barrel encapsulating portions or protective cap. The ridge and groove connection means may be a once only i.e. non removable, fit. Each groove may be annular groove formed on an interior surface of a dome shaped protective cap for interconnection with a corresponding ridge on the exterior surface of the needle encapsulating portion, or vice versa. Each groove may include a bevel of preferably 45°. Preferably the protective cap is a taper fit to the needle encapsulating portion for retention thereof. It is envisaged that the protective cap may cover substantially all of the needle encapsulating portion, thus alleviating the risk of penetration by a bent or curved needle. Preferably the protective cap additionally covers shoulder portions of the syringe barrel encapsulating portion formed proximate the juncture of the barrel encapsulating portion and needle encapsulating portion. BRIEF DESCRIPTION OF THE DRAWINGS The invention will be more fully understood from the following description made with reference to the following drawings in which: Figure 1 shows a perspective view of the syringe safety device according to an embodiment of the present invention. Figure 2 shows a longitudinal cross section through the syringe safety device shown in Figure 1. Figure 3 shows an external side view of the syringe safety device according to Figure 1. Figure 4 shows a partial sectional view of the syringe safety device during insertion of the syringe therein. Figure 5 shows a similar partial sectional view as shown in Figure 4 with the syringe retained by the engaging means. Figures 6a-6d show sectional views of a syringe safety device according to alternative embodiments of the present invention. In particular Figures 6b-d show various embodiments of the protective cap on the needle encapsulating portion. Figure 7 shows an end section of the syringe safety device according to the present invention with a protective cap. Figure 8 shows a partial sectional view of an alternative embodiment of the syringe safety device of the present invention including a protective cap connected to an end of a syringe barrel encapsulating portion of the device. Figure 9 shows a partial sectional view of the an alternative arrangement of the embodiment according to Figure 8.
DESCRIPTION OF PREFERRED EMBODIMENT Referring firstly to Figure 1 , there is shown a syringe safety device 10 according to a preferred embodiment of the present invention. Referring to Figure 1 of the drawings, there is shown the syringe safety device 10 of the present invention fabricated from a rigid polymeric material. The syringe safety device 10 includes a needle encapsulating portion 12, a syringe barrel encapsulating portion 14 and a syringe retention portion 16. It will be observed that the retention portion 16 has a greater width along substantially its whole length than an outer diameter of the syringe barrel encapsulating portion 14 or needle encapsulating portion 12. Thus the retention portion is sufficiently wide to accommodate the transversely extending portions (flanges) of a syringe barrel. The syringe safety device 10 according to the present invention is suitable for safely containing and/or transporting or disposing of typical syringes used for injecting, for example, intravenously or subcutaneously. The syringe retention portion 16 has an open end 18 to allow a syringe to be placed by insertion into the device 10. Particularly, the opening is of sufficient lateral dimension to amply accommodate the barrel and flanges, thus assisting with location. At another opposed end 19, retention portion 16 communicates with the syringe barrel encapsulating portion 14. The body 15 of the retention portion 16 extends between the open end 18 and opposed end 19. The body 15 is provided with engagement means 20 (not shown) internal thereof for retaining a syringe within the disposal device 10 after passage of flange portions past engaging means 20. The retention portion 16 further includes slots 21 a, 21 b and 22a, 22b. Slot 21a corresponds with slot 21 b on the reverse side of the body 15, and similarly, slot 22a corresponds with slot 22b. Slots 21a and 22b permit a member 23 of the body 15 of the retention portion 16 to resiliently flex and thus allow the flange to pass the engaging means during insertion of a syringe into the device 10. The engaging means thereafter returns or partially returns to its original position to retain the flange. Thus the syringe is prevented from being readily removed from the device. Similarly, slots 22a and 22b permit a further member 24 of the body 15 to resiliently flex during insertion of a syringe into the device. It will be appreciated that the retention device 10 may include one or more such resilient members 23, 24. It will be appreciated that the syringe may include a cap over the plunger to prevent insertion of the syringe into the disposal device until the cap is removed. Thus the flanges are prevented from engagement with the engaging means until the cap is removed from the plunger and, following use, the syringe is ready to be retained in the device. Other arrangements to prevent this result are however possible. Figure 2 shows a longitudinal sectional view of the device 10 of Figure 1. Slots 21 b and 22b are shown in the section. Engaging means 20a, 20b are shown on corresponding body portions 23, 24. According to the embodiment shown, the engaging means 20a, 20b are integral with the body 15 as wedge shaped projections. As shown, the device may include one or more webs 25. These webs may act to guide the flanges of a syringe during insertion and to restrict lateral movement of the syringe within the device by contact with the flanges once retained in position. However, it will be appreciated that the device need not include these webs and a close or interference fit of the body with the syringe may alternatively restrict movement of the syringe. The slots 21b, 22b (and 21 a, 22a) are shown having rounded inboard ends. Such rounded ends help prevent the slots enlarging due to weakening of the material of the device and in addition aid flexure of the body portions 23, 24 during insertion of a syringe. The skilled addressee will appreciate that the slots need not be limited to this particular shape and that other arrangements are envisaged. For example generally triangular ends or simple regular elongate slots may be provided. Preferably however the slots include rounded ends so as to reduce the risk of fracture of the material of the retention portion 16 at the stress point caused by flexure of the material. It is not necessary that it be the transversely extending flange portion of the syringe that passes the engaging means. Another portion of the syringe may alternatively or additionally be engaged and this may be necessary for syringes of other design. Further, other forms of engaging means may be contemplated by the present invention. For example, one or more channels or apertures in the body may be provided. In the case of apertures, a visual indication that the syringe is retained or "locked" in position for disposal may be given by one or more portions of the barrel extending through or be visible through said apertures. The device 10 is conveniently manufactured from a polymeric material.
This is not to preclude fabrication from other materials. The polymeric material must have sufficient stiffness to prevent puncture by a needle. Polyamide polymers, such as nylons, may be most suitable for this application. Otherwise, the transversely extending portion may be formed by a syringe barrel outer surface or indeed any other appropriate surface of the syringe. It is contemplated that the device 10 may be used for all conventional designs of syringe as, in this way, efficacy of retention device 10 will be best promoted. With regard to the side exterior view of one embodiment of the device 10 as shown in Figure 3, the slots 21a, 22a are shown as corresponding, that is, directly overlying in plan view, the associated slots 21 b, 22b on the reverse of the device 10. Thus the paired slots 21a, 21 b and 22a, 22b define the retaining means including the engagement means 20a,20b of the device. In Figure 4, which shows a partial cross section of the device 10, a syringe 30 is shown in a position during insertion in the direction of arrow 'A'. The syringe includes a barrel 31 , a plunger 32 and transverse extending portions or flanges 33a,33b. The retention portion 16 includes retaining means in the form of a resilient member 23, 24 having at least one projection or lug 20a, 20b extending towards the syringe from two sides of the device. The engaging means include, in the embodiment, inclined portions or ramps 26a, 27a. Thus as the syringe enters the device each flange 33a,33b contacts a corresponding ramp 26a, 27a which causes the respective resilient member 23, 24 to flex away from the syringe due to the narrower width of the syringe at that portion than the retention portion 16. Slots 22a, 22b (and corresponding slots 21a, 22a) permit flexure of the resilient members formed integral of side walls of the body 15 of the retention portion 16. Strengthening ribs 25 reduce excess flexure of the retention portion 16 and help to prevent excess sideways movement of the syringe once retained in position. Figure 5 shows a similar partial sectional view as shown in Figure 4, however, the syringe 30 is shown in a retained or locked position subsequent to insertion into the device 10. It can be clearly seen that the projections 20a, 20b are resiliently returned to an un-flexed position following passage of the flanges 33a, 33b therepast. The slots 21 b, 22b (and correspondingly 21a, 22a) are seen in an un-widened attitude due to the substantial removal of flexural stresses at the rounded inboard ends 28a, 28b. However, it will be appreciated that the resilient members 23, 24 may remain at least partly flexed so long as the syringe is safely retained in position by the engaging means 20a, 20b. It is to be noted that the needle encapsulating portion 12 is formed of material sufficiently rigid and/or dense to avoid the possibility of needle puncturing it. Polymeric materials may be selected to achieve this purpose as described above. Preferably the device 10 includes a syringe retention portion for retaining a syringe inserted into the device, with the syringe barrel including a projecting portion for engagement with the retention portion of the device. Figures 6b-6d show sectional views of further embodiments according to the present invention. For example, Figure 6b shows the syringe safety device 10 with a protective cap 40. The cap 40 entirely covers the needle encapsulating portion 12 and includes a shoulder cover portion 41 covering a shoulder formed on the device at the juncture between the needle encapsulating portion 12 and the barrel encapsulating portion 14. An alternative embodiment shown in Figure 6c extends to meet the shoulder 42 but does not include the shoulder cover portion 41. Figure 6d shows a further embodiment of the protective cover 40 with thickened side wall 43 which extends to cover the shoulder 42 without a shoulder cover portion 41. The protective cap may be formed integrally with the device or separately and connected or joined as required. Connection may be by mechanical means, for example, interconnecting ridge and groove means or adhesive. Alternatively a taper or interference fit is envisaged. With respect to Figure 7, there is shown an end portion of the device 10 with the protective cap 40. The cap 40 includes in this embodiment an annular groove 50, which may, as shown, have a 45° bevel 51 , for interconnection with a corresponding ridge 52 on the needle encapsulating portion 12. With respect to Figure 8, the device 10 includes a protective cap 60 connected to an end of a barrel encapsulating portion 61. The protective cap 60 shown also forms the needle encapsulating portion. However, it will be appreciated that the protective cap 60 may be provided in addition to a separate needle encapsulating portion. An end 62 of the barrel encapsulating portion 61 includes a stepped or cutaway portion 63. The protective cap includes a corresponding stepped or cutaway portion 64 for engagement with the corresponding stepped portion of the barrel encapsulating portion. The connection may be by interference fit, adhesive means, and/or other suitable connection means, for example, inter-engaging ridge and groove means 65, 66 such as depicted in Figure 9. According to an alternative embodiment the stepping may be reversed such that the protective cap inserts fits into and engages with an inner surface 67 of the barrel encapsulating portion. The protective cap is preferably of a harder material than that of the remainder of the device, though may be of the same hardness provided that the material prevents puncture of the cap by a syringe needle.

Claims

THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:
1. A syringe safety device for a syringe including a barrel and plunger, wherein the barrel includes a projecting portion for engagement with the safety device, the safety device including a needle encapsulating portion, a syringe barrel encapsulating portion, and a syringe retention portion, said syringe retention portion including; (a) an open end for insertion therein of a syringe; (b) an opposed end communicating said retention portion with said syringe barrel encapsulating portion; (c) a body extending between the open and opposed ends including a resilient member and an engagement means for retaining the syringe; wherein the resilient member is flexed by the projecting portion to permit passage of the syringe into the device and subsequent engagement with the engaging means to retain the syringe within the device.
2. A device as claimed in claim 1 , wherein the syringe retention portion includes two or more of said resilient members.
3. A device as claimed in claim 1 or 2, wherein the syringe retention portion includes two or more of said engaging means.
4. A device as claimed in any one of the preceding claims wherein each retaining means is integral with a corresponding resilient member.
5. A device as claimed in any one of the preceding claims, wherein the engaging means are in the form of projections.
6. A device as claimed in claim 5, wherein the engaging means are one or more lugs or ridges, or inclined (ramp) portions allowing the syringe projecting portion to gradually increase pressure against the resilient member during insertion of the syringe thereby gradually flexing away the resilient member to permit passage of the syringe into the device.
7. A device according to any one of the preceding claims, wherein the body of the retention portion includes one or more side walls tapered with respect to the syringe such that the apparent width of the opening decreases as the syringe is inserted and the resilient member is a portion of at least one wall of the body which flexes to allow passage of the syringe projecting portion.
8. A device according to any one of the preceding claims, wherein each resilient member is formed in the body of the retention portion by providing slots in at least one of the walls thereof, the slots defining therebetween at least one resilient member.
9. A device as claimed in claim 8, wherein the slots extend from the opposed end of the retention portion part way along the at least one wall towards the open end of the retention portion.
10. A device as claimed in claim 8 or 9, wherein alternatively or in addition, the slots extend from the open end towards the opposed end of the retaining portion.
11. A device as claimed in any one of the preceding claims, wherein the syringe safety device is arranged to receive and retain a syringe wherein the projecting portion of the syringe barrel is a transverse extending portion or flange, and the retaining means retains the transverse extending portion or flange.
12. A device as claimed in any one of the preceding claims, wherein the engaging means includes one or more channels or apertures in the body of the retention portion, such that, as the syringe passes into the device, each resilient member flexes to effectively increase the width of the body and permit passage of the syringe and thereafter each projecting portion of the syringe engages with the channels or apertures in the body to retain the syringe.
13. A device as claimed in claim 12, wherein on engagement, each resilient member at least partially returns to an unflexed (pre syringe insertion) position.
14. A device as claimed in any one of the preceding claims, wherein the syringe flanges extend beyond the exterior dimensions of the retention portion through at least one aperture once retained by the engaging means, thereby giving a visual indication that the syringe is "locked" into a retained position.
15. A device as claimed in any one of the preceding claims, wherein the device is fabricated from a polymer material having sufficient strength to prevent needle puncture but resiliently flexible enough to form the retaining means.
16. A method of retaining a syringe in a syringe safety device including the steps of; (a) inserting a syringe having a barrel with a portion extending thereof and a plunger into the syringe safety device (b) flexing the resilient portion by contact of the extending portion to permit passage of the syringe (c) engaging and retaining the extending portion to retain the syringe within the device.
17. A syringe safety device for a syringe having a barrel and a needle, the device including; (a) a syringe barrel encapsulating portion; and (b) a protective cap; wherein, the protective cap is of sufficiently hard material to prevent the tip of a syringe needle inserted into the device from penetrating through from the interior to the exterior of the device.
18. A device according to any one of the preceding claims, wherein the device includes a needle encapsulating portion connected at one end of the barrel encapsulating portion and in communication therewith for receiving the syringe needle.
19. A device according to claim 18, wherein the needle encapsulating portion may fully or partially closes off the end of the barrel encapsulating portion.
20. A device according to claim 18 or 19, wherein the protective cap also forms the needle encapsulating portion.
21. A device according to any one of claims 18 to 20, wherein the device includes an insert portion for insertion into and engage with the interior of the barrel encapsulating portion to form the needle encapsulating portion and/or seating means for an end of a syringe barrel placed in the device.
22. A device according to any one of claims 18 to 21 , wherein the protective cap is formed separately of the remainder of the device and subsequently arranged to fit over and cover the end of the barrel encapsulating portion and/or needle encapsulating portion as appropriate.
23. A device according to any one of claims 18 to 22, wherein the protective cap is connected to the barrel encapsulating portion and/or the needle encapsulating portion by adhesive or mechanical connection means, such as an inter-cooperating ridge and groove, or clip or snap fit means.
24. A device according to claim 23, wherein the mechanical connection means includes at least one engagement means, such as a ridge or groove on one or both of the needle encapsulating portion or barrel encapsulating portion with at least one corresponding engagement means, such as a groove or ridge provided on the cap such that the protective cap can be connected to the remainder of the device to cover and protect the end thereof from needle puncture.
PCT/AU2004/000952 2003-07-15 2004-07-15 Improved syringe safety device WO2005004957A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AU2003903633A AU2003903633A0 (en) 2003-07-15 2003-07-15 Improved syringe safety device
AU2003903633 2003-07-15

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5366447A (en) * 1993-12-13 1994-11-22 Gurley Carol A Protective sleeve for a hypodermic syringe
EP0506204B1 (en) * 1988-06-28 1996-04-17 Sherwood Medical Company Combined syringe and needle shield and method of manufacture
US5997513A (en) * 1995-11-22 1999-12-07 Smith; Jerry A. Syringe cover cooperating with needle cover
WO2003041766A2 (en) * 2001-11-14 2003-05-22 Sherwood Services Ag Safety needle apparatus
US20030144632A1 (en) * 2002-01-30 2003-07-31 Edgar Hommann Injection device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0506204B1 (en) * 1988-06-28 1996-04-17 Sherwood Medical Company Combined syringe and needle shield and method of manufacture
US5366447A (en) * 1993-12-13 1994-11-22 Gurley Carol A Protective sleeve for a hypodermic syringe
US5997513A (en) * 1995-11-22 1999-12-07 Smith; Jerry A. Syringe cover cooperating with needle cover
WO2003041766A2 (en) * 2001-11-14 2003-05-22 Sherwood Services Ag Safety needle apparatus
US20030144632A1 (en) * 2002-01-30 2003-07-31 Edgar Hommann Injection device

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