Security assembly for a syringe device

The present invention relates to a safety assembly intended to equip a syringe and a syringe assembly.

Certain medical products are packaged directly in a body standard syringe (prefilled syringe), usually glass, sealed by a piston which is connected a piston actuating pusher.

The body of a syringe is generally provided with an end of connection to an injection needle, said injection end, and one end the introduction of piston. so you can access the product contained in the syringe by each of these ends for example by withdrawing the piston of the syringe body either by pumping or aspirating the product through the needle. One can also access product contained in the syringe by means of an injection needle which are inserted in through the piston, generally in elastomer, after removing the pusher.

already known in the prior art, particularly from FR 2799375 A1 (FR 99 12500), a safety assembly for fitting to a syringe comprising a body having a connecting end with an injection needle, said end injection, and an insertion end of a piston, the security assembly being of the type comprising:<ul><li>a member to be attached to the body of the syringe so axially secured to this body, and</li><li>a safety cap for covering the injection end of the body, having a proximal portion for attachment to the fitted member and a distal portion clearance of the injection end connected to the hooking portion by frangible means.</li></ul>

After attachment to the body of the syringe to the proximal part of Safety cap, the injection end of the syringe body can not be released after breaking frangible means. Thus, fraudulent access to the product contained in the syringe through the injection end of the body of the syringe is revealed by the rupture of the frangible means.

Are also known in the prior art, in particular from DE 29 45 869 A1, a piston retainer member within the body of the syringe allowing including preventing inadvertent or fraudulent withdrawal of the piston.

The invention aims in particular to detect and / or prevent access fraudulent the product contained in the syringe, particularly when the syringe is offered for sale, using this simple and effective ways.

To this end, the invention relates to a safety assembly intended to equip a syringe pre-mentioned type, characterized in that the fitted member forms a body for retaining the piston within the body.

Thus, the safety assembly according to the invention, at a time, to authorize access to the injection end of the syringe body (whether or not fitted with a needle) after breaking frangible means (so that a fraudulent access to the product contained in the syringe through the injection end of the body of the syringe is revealed by breaking this frangible means) and preventing inadvertent withdrawal or fraudulent the piston and / or the plunger of the syringe.

According to other optional features of this safety system:<ul><li>the connection portion of the security cap forms means radial retention of the attachment member on the body of the syringe;</li><li>the fitted member comprises at least one annular skirt sector, said centering sector for co-operating with a complementary surface delimiting the body of the syringe to radially position the body reported relative to the body of the syringe;</li><li>the safety cap is hooked on the insert member by means of complementary locking means carried by the hooking part of the security cap and the fitted member, these latching means Additional being nestable one within the other irreversibly;</li><li>the complementary snap-fastening means comprise complementary locking shoulders formed of, respectively, on a substantially annular end of the connection portion of the safety cap and at least one annular skirt sector secured to the fitted member, said locking sector;</li><li>centering sector is radially inward relative to the sector latching, the substantially annular end of the portion of the safety cap hanging sandwiched radially between these centering and latching sectors;</li><li>the locking shoulder formed on the ratchet sector is adjacent to circumferential slots formed in the sector latching;</li><li>the safety assembly being intended to equip a syringe having a body having an insertion end of a piston defined by a flange, the fitted member comprises proximal and distal flanges for pinching axial flange for securing axially the organ based on the body of the syringe, the proximal plate forming a collar for retaining the piston within the body;</li><li>the distal plate carries the centering sector;</li><li>the distal plate carries the snap-fastening means intended to cooperate with the complementary snap-fastening means carried by the part attachment of the safety cap;</li><li>the distal plate includes an opening for the socket around the body of the syringe, said opening fitting opening into a direction substantially parallel to the plates, the contour of the flange delimiting the distal opening nesting preferably having a form "U";</li><li>the safety assembly being intended to equip a syringe having a body with a piston, the security assembly comprises a rod forming a pusher adapted to be connected to the piston and the proximal flange comprises an opening for the axial displacement of the pusher, this opening Deflection preferably opening in a direction substantially parallel to the flanges, the contour of the proximal plate defining the opening movement of the piston forming retaining collar and preferably having a shape of a "U";</li><li>the plunger has an inner distal end of the body provided with a disc forming a drill protection of the piston and / or a stop intended to cooperate with the proximal plate forming a flange for retaining the piston and the distal end of the plunger within the body;</li><li>the fitted member comprises rotation immobilization means intended to cooperate with complementary means of the collar of the the syringe body, these immobilisation means in rotation being provided preferably flats formed in the fitted member so as to extend axially between the two flanges;</li><li>the fitted member is provided with support means for a user's fingers preferably comprising two gripping wings substantially diametrically opposed;</li><li>the safety cap has a general shape of revolution, the means comprising a frangible annular gap between the two parts of the security cap, said slot being interrupted by bridges frangible connecting the two parts of the safety cap; </li><li>parts disengagement and the security cap is hanging provided with complementary hooking means capable of cooperate with each other after breaking frangible means;</li><li>the complementary hooking-in means includes means Additional interlocking snap fitted shoulders Additional locking and additional end stops Nesting race provided on the parties, respectively release and attachment of the safety cap;</li><li>additional stops limit are delimited, respectively, an external projection, for example annular, arranged on one of the parts of the safety cap and an edge of the other of parts of the security cap delimiting the annular slot;</li><li>the security cap is made of a transparent material to particular, to allow visual access to a label carried by the syringe;</li><li>the release portion of the security cap is designed to form a protective cap of the injection needle;</li><li>the release portion of the security cap is designed to be connected a protective cap from the injection needle.</li></ul>

The invention also relates to a set of type of syringe comprising a syringe comprising a body provided with a connecting end to an injection needle, said injection end, and an insertion end of a piston, characterized in that it further comprises a set of security as defined previously.

The invention will be better understood on reading the description which follows, given by way of example only and with reference to the accompanying drawings in which :<ul><li>Figure 1 is a perspective view of a syringe assembly according to a first embodiment of the invention;</li><li>Figure 2 is an axial sectional view of the syringe assembly shown in Figure 1;</li><li>Figures 3 to 5 are perspective views, partially broken away, of at least a portion of the syringe assembly shown in Figure 1 in different mounting configurations or use; </li><li>Figures 6 and 7 are perspective views, in two views different, a member to be attached to the body of the syringe of the syringe assembly shown in Figure 1;</li><li>Figure 8 is a view similar to FIG 1 of a syringe assembly according to a second embodiment of the invention;</li><li>Figures 9 and 10 are partial views in axial section of the assembly syringe shown in Figure 8 showing the safety cap before and after a first use of the syringe.</li></ul>

There is shown in Figures 1 and 2 a syringe assembly according to a first embodiment of the invention, designated by the general reference 10.

The syringe assembly 10 includes a syringe 12 for injection a liquid, in particular medical type equipped with a safety assembly 13 according the invention.

In what follows, we will call a proximal element of the set of Safety syringe or close axially from the hand of a user and a distal element of this syringe assembly or remote security of the hand of the user.

Conventionally, the syringe 12, shown particularly in Figures 2 and 3, comprises a tubular body 14, for example glass. This body 14 is provided with a 14D distal end for connection to an injection needle 16. The end 14D will be referred to subsequently injection end. The body 14 is also provided with a 14P open proximal end allowing the introduction of a piston 18 in the body 14. This piston 18, of conventional type, for example elastomer.

Note that the 14P insertion end is delimited by a collar 20. In the example described, the flange 20 is delimited by a circular contour interrupted by two substantially straight portions 20R, diametrically opposed, visible in particular in Figure 3. Alternatively, the flange may be bounded by a uninterrupted circular contour.

The safety assembly 13 comprises a security pusher 22 provided with a 22D distal end, inside the body 14, connected, for example by screwing, to the piston 18, 22P and a proximal end outside the body 14, forming maneuvering end the pusher 22.

The injection end 14D of the body and the needle 16 are covered by a Classic cap 24 provided protection in the example described, a casing 24E outer and an inner casing 241, for example elastomer.

The safety assembly 13 also includes an insert member 26 on the body 14 and a safety cap 28 covering it, by surrounding them, the cap protection 24, the needle 16 and the injection end 14D of the body of the syringe.

Safety cap 28 is provided with a proximal portion 28P for be attached on the body 14 of the syringe, through the fitted member 26, and a distal portion 28D of clearance of the injection end of the body 14D of the syringe. The attachment portion 28P is connected to the release portion 28D using frangible means 30.

It will be appreciated that the syringe 12 and the safety cap 28 have shapes Terms of revolution.

The frangible means 30 of the safety cap 28 include, for example, an annular gap 32 separating the two parts 28D, 28P of the cap of security. The slot 32 is interrupted by frangible bridges 34 connecting the two parts 28D and 28P of the security cap.

Preferably, the safety cap 28 is made of a material transparent, for example plastic, in particular to allow visual access to a label carried by the syringe 12, for example by the protective cap 24.

The axial positioning of the frangible means 30 of the safety cap 28 may vary as appropriate. Preferably, when the syringe 12 has a label intended to be detached or peeled, the frangible means 30 are positioned on the safety cap 28 so as to allow, after rupture of the frangible means, to access the label to peel off or peel.

According to a first variant, the protective cap 24 may be removed, the release portion 28D of the safety cap 28 then forming a protective cap of the injection needle 16.

According to a second variant, the disengaging portion 28D of the cap Security can be connected to the protective cap 24 so that the separation of relief portion of 28D with the connection portion 28P of the safety cap causes separation of the protective cap 24 with the injection end of the 14D body of the syringe.

With particular reference firstly to Figures 1 and 2, and secondly, to Figures 6 and 7 in which the insert member 26 is shown in more detail, one sees reported that this member 26 includes proximal and distal flanges 36P 36D for axially pinch collar 20 to secure axially reported 26 to organ body 14 of the syringe.

The insert member 26 forms a member for retaining the piston 18 and 22D the distal end of the plunger within the body 14 of the syringe. Indeed, the proximal plate 36P forms a collar for retaining the piston 18 within the body 14.

more particularly it will be noted that the proximal plate 36P includes a opening 38 for the axial displacement of the pusher 22. The contour of the flange 36P proximal delimiting this opening movement 38 form the retaining collar piston 18. Preferably, the deflection opening 18 opens in a direction substantially parallel to the flanges 36P, 36D, that is to say in a direction substantially perpendicular to the axis of the syringe 12. The outline of the proximal plate 36P delimiting this opening 38 preferably has a shape of a "U" so as to have substantially straight and parallel edges separated them from a distance adapted to allow a transverse movement of the proximal plate 36P relatively to the plunger 22.

It will be noted that the inner end 22D of the pusher is provided with a disc 40 forming a piston retainer stop 18 intended to cooperate with the proximal plate 36P forming collar. In the illustrated example, the disc 40 is axially adjacent the piston 18. Furthermore, the disc 40 forms an anti-drill protection of piston 18.

The distal plate 36D has an opening 42 for the insertion of this distal plate 36D around the body 14 of the syringe. This opening nesting 42 opens in a direction substantially parallel to the plates 36D, 36P, that is to say, in a direction substantially perpendicular to the axis of the syringe 12. The contour the distal plate 36D defining the opening fitting 42 preferably has a form "U" so as to have substantially straight and parallel edges spaced between them by a distance adapted to allow a transverse engagement of the flange 36D on the distal body 14 of the syringe.

Preferably, the insert member 26 includes a pair of flats 44, diametrically opposite, provided in the insert member 26 so as to extend axially between the two flanges 36P, 36D. These flats 44 may form means for preventing rotation of the insert member 26 relative to the body 14 of the syringe intended to cooperate with the straight edges of the flange 20R forming means for preventing further rotation.

Referring in particular to Figures 4, 6 and 7, it is seen that the distal plate 36D includes at least a sector of annular skirt 46, said centering sector, for to cooperate with a complementary surface delimiting the body 14 of the syringe radially positioning the insert member 26 relative to the body 14. In the example illustrated, the centering area 46, formed integrally with the distal flange 36D extends substantially 180 ° and cooperates with the outer surface of the body 14 of the syringe.

Safety cap 28 is intended to be hung on the insert member 26. After this attachment member 26 reported, the safety cap 28 extends around the body 14 of the syringe substantially coaxially with the body 14. Thus, the Safety cap 28, specifically the fastening portion 28P of the latter, form of radial retaining means of the insert member 26 on the body 14 of the syringe.

Preferably, the safety cap 28 is hooked on the insert member 26 with complementary latching means 48 carried by the portion 28P attachment of the safety cap and insert member 26. These means Additional ratchet 48 are nestable one in the other so irreversible, ie a possible disengagement of the latching means 48 leaves a visible trace.

In the example shown in the figures, the latching means Additional 48 comprise complementary shoulders 50 of locking, 52, formed respectively on a substantially annular end of the portion 28P of catching the safety cap (see in particular Figures 2 and 4) and the least one sector 54 to come annular skirt integral with the distal plate 36D of the insert member (see in particular Figures 2 and 7). Thereafter, the sector will be called 54 ratchet sector.

In the illustrated example, the centering sector 46 extends over more than 180 °.

It will be noted, with particular reference to Figures 1 and 7, the shoulder Lock 52, formed on the ratchet sector 54, is axially adjacent to circumferential slots 56 formed in the locking sector 54. These slots 56 promote complementary snap means 48.

It is also noted, by referring in particular Figures 4 and 7, the centering sector 46 is radially internal relative to the ratchet sector 54. After snapping complementary means 48, the substantially annular end of the attachment portion 28P of the security cap is radially interposed between centering sectors 46 and 54 snap.

Preferably, the insert member 26 is provided with fingers of support means a user including, for example, two radial gripping wings 58 substantially diametrically opposed.

Note that the safety assembly 13 can be sold independently of the syringe 12 in the form of a set composed of the pusher Security 22, the insert member 26 and the safety cap 28, the various elements of lot may be mounted on the syringe 12, if any pre-filled comprising body 14 and the piston 18.

The set of security 13 of the invention is very simple indeed to climb 12 on the syringe.

Initially, connects the pusher 22 to the piston 18 to obtain the set shown in Figure 3 wherein the protective cap 24 is fitted over the injection end 14D of the body of the syringe.

Mounting the safety assembly 13 of the syringe 12 is continued the fitting member 26 reported on the flange 20 of the body 14 of the syringe. This Nesting is effected by relative movement of the member 26 and the body 14 of the syringe substantially perpendicular to the axis of the syringe 12 as permitted openings in "U" 38, 42 formed in the proximal and distal flanges 36P 36D of the fitted member.

In the configuration of Figure 4, the insert member 26 is immobilized axially relative to the body 14 of the syringe but is not retained radially on this body 14. Note that the insert member 26 may be mounted on the collar 20 in presence of the plunger 22 of the syringe 12.

The insert member 26 being hooked on the body 14 of the syringe as shown in Figure 4, then snaps the safety cap 28 of reported the member 26 so that the cap 28 covers the body 14 of the syringe and the cap 24 protecting the needle 16, as shown in Figure 1.

After locking of the safety cap 28 of the insert member 26, this latter is locked radially relative to the body 14 of the syringe.

To access the needle 16 of the syringe, a user acts on the end of 28D release of the security cap so as to break the frangible bridges 34 and separate this release portion 28D of the connection portion with 28P remains attached to the fitted member 26, as shown in Figure 5.

After removal of the release portion 28D of the safety cap, the user can access the protective cap 24 and normally remove the syringe to use this syringe under the usual conditions.

Access to the needle 16 of the syringe can not be done after rupture frangible bridges 34 and separation of the release portion 28D of the cap security with the connection portion 28P of the cap, a malicious access the needle 16 is easy to detect.

Furthermore, the fitted member 26, said collar, prevents withdrawal unwanted or malicious the piston 18 of the body 14 of the syringe.

Where appropriate, to enable the detection of a fraudulent replacement of an element of the safety assembly 13, at least one member of the set of Security 13, for example the safety cap 28 or the insert member 26 can comprise a chemical element or an invisible marking to the naked eye but capable to be detected using suitable means such as a spectrometer radiation ultraviolet or infrared or lighting such as an adapted radiation in particular ultraviolet radiation.

Optionally, a breakable zone may be provided on the pusher 22 and / or reported the member 26 to cause rupture of one or the other of such bodies when an attempted withdrawal by the force of the piston 18 of the body 14 of the syringe.

There is shown in the Figures 8 to 10 a syringe assembly according to a second embodiment of the invention. In these figures, elements similar to those Figures 1 to 7 are designated by identical references.

For reasons of clarity, the protective cap 24 is not shown Figures 9 and 10.

In this case, the 28D release parts and attachment of 28P Safety cap 28 are provided with complementary fastening means likely to cooperate with each other after breaking the frangible means 30 so as to power, after the first use of the syringe under the usual conditions, isolate outside the injection end 14D and the needle 16 of the syringe.

Preferably, as can be seen in particular in Figures 9 and 10, the complementary attachment means comprise snap means Additional interlocking 60 provided with complementary locking shoulders 62, 64 and additional end stops nesting race 66, 68 provided on parties, respectively 28D 28P clearance and hooking the cap 28 security.

Supplemental limit stops 66, 68 are delimited, respectively, by an external projection 70, for example annular, arranged on one of the parts of the safety cap 28, namely the release portion 28D in Example illustrated, and an edge of the other portions of the cap 28, namely the part attachment of 28P in the example shown, delimiting the annular gap 32 before break frangible bridges 34 (see Figure 9).

Note that before their break, the frangible bridges 34 extend substantially between engagement ramps 72, 74 of the latching means Additional 60.

As in the first embodiment of the invention, to reach the needle 16 of the syringe, a user acts on the end of the clearance 28D safety cap so as to break the frangible bridges 34 and separate this part of 28D with release of the connection portion 28P which remains attached to the body reported 26.

After removal of the release portion 28D of the safety cap, the user can use the syringe under the usual conditions.

After this use, the user is isolated from the outside the injection end 14D and the needle 16 by snapping the release portion 28D on the connection portion 28P of the security cap, as shown in Figure 10. Preferably, the complementary snap-fastening means 60 are nestable one within the other irreversibly.

The invention is not limited to the embodiments described above.

In particular, the insert member 26, in particular for retaining the piston 18 in the body of the syringe may have a different structure from that described above.

Moreover, the radial positioning of the organ reported relative to the body of the syringe may be achieved by means carried by the safety cap rather that the centering sector carried by the fitted member.