EP2582420A1

EP2582420A1 - Syringe and safety device assembly

Info

Publication number: EP2582420A1
Application number: EP11735471.2A
Authority: EP
Inventors: Sylvain Lanzi; Pascal Dugand; Thierry Rimlinger
Original assignee: Rexam Healthcare La Verpilliere SAS
Current assignee: Nemera la Verpilliere SAS
Priority date: 2010-06-17
Filing date: 2011-06-09
Publication date: 2013-04-24
Also published as: FR2961403B1; FR2961403A1; US9186462B2; US20130184655A1; WO2011157930A1; CN103002935A

Abstract

The invention relates to a syringe assembly (10) including a syringe (12) and a safety device (33), the syringe including a tubular body (14), the safety device including a tubular member (36), referred to as a syringe holder, in which the body is arranged, such that the syringe holder and the body are axially secured to each other. The syringe body includes a collar (16) at the proximal end thereof, which is translatably immobilized between a peripheral bearing seat (38) and an abutment of the holder. The assembly also includes at least one pad (50) inserted between the seat and the collar and compressed therebetween, said pad being made of a material, the coefficient of friction of which relative to at least one of the materials of the collar or seat is higher than the coefficient of friction of the materials of the collar and seat relative to one another, in particular an elastomer.

Description

Set of syringe and safety device

The present invention relates to the field of safety devices for liquid injection syringe, in particular for pre-filled syringe.

Already known in the state of the art, particularly from EP 2,047,879, a liquid injection syringe of the type comprising a body of generally tubular form forming a reservoir for the liquid on which is attached a shaped tip general annular for attaching a needle holder to the syringe body.

The attachment end is sometimes referred to as "luer lock" and the needle holder is sometimes referred to as "luer hub".

The syringe also comprises a pusher mounted axially movable in the body between a standby position and an end position of liquid injection.

In what follows, an element will be described as proximal or distal depending on whether it is near or far away from the end of the pusher intended to be actuated by a user.

EP 2 047 879 also describes a safety device for such a syringe, this device comprising:

a first organ of generally tubular shape, designated protective sheath, and

a second organ of tubular general shape, designated syringe holder, housed in the sleeve substantially coaxially with the latter.

The protective sheath and syringe support are axially movable relative to each other between two positions which will be called hereafter position of disengagement of the syringe needle and the retraction position of this needle. The syringe body is however axially secured to the syringe holder. A collar located at the proximal end of the syringe body is immobilized axially with a slight clearance, due to the dispersion of the dimensions of the syringe body, in a housing located between a support seat and retractable stops of the support.

The safety device allows an automatic retraction of the needle in the sheath to prevent a person handling the syringe assembly after normal use, that is to say after injection of the liquid into the body of the syringe. a patient, does not accidentally prick with the needle.

The attachment end has a proximal end generally fitted on a distal end of the body of the generally cone shaped syringe.

Furthermore, the attachment end has a distal end intended for cooperate by screwing with a needle holder. This needle holder and the needle it carries are covered, before use of the syringe, by a cap. If necessary, before placing the needle holder on the body of the syringe, a closure cap of the body of the syringe is screwed onto the attachment end.

The torque necessary for unscrewing the cap or screwing the needle holder is capable of rotating the body of the syringe relative to the safety device. It is therefore appropriate to be able to oppose the rotation of the attachment end to achieve in particular to unscrew the cap or screw the needle holder.

However, after mounting the syringe in the safety device, the attachment tip is generally made virtually inaccessible by the protective sleeve which covers it. The user can not act directly on the attachment end to immobilize it in rotation, in particular when unscrewing the cap or screwing the needle holder.

For this purpose, the device described in EP 2,047,879 comprises a syringe holder provided with first means for securing in rotation about its axis comprising at least one pawl resiliently biased into a position in which this pawl is intended to cooperate with means additional securing rotation carried by the attachment end.

This makes it possible to secure the tip and the syringe holder in rotation and thus facilitate the operations of unscrewing the cap and screwing the needle holder.

However, the securing means of the syringe holder with the tip can be activated only when the tip placed on the syringe body has a particular shape, including ribbed. It is therefore not possible to immobilize in rotation with such a device a syringe not having this specific tip.

The object of the invention is to remedy this drawback by proposing a solution to the problem of immobilizing the syringe in rotation with a view to unscrewing the stopper and screwing the needle holder which is adapted to all types of syringes, whatever the mouthpiece that she wears.

For this purpose, the invention relates to a syringe assembly comprising a syringe for injecting liquid and a safety device, the syringe comprising a generally tubular body forming a reservoir for the liquid and the safety device comprising a organ, referred to as a syringe support, in which the syringe body is arranged, so that the syringe support and the syringe body are axially integral, the syringe body comprising at a proximal end a collar immobilized in translation between a part of a peripheral support seat and secondly at least one stop of the syringe support. The assembly also includes, interposed between the seat of the support and the collar of the body, the less a pad in compression between the seat and the flange, the pad being made of an elastic material.

The pad is a means for immobilizing the tip in rotation relative to the syringe support. This pad can be fixed on the body or the support, for example by gluing, or be mounted between the body and the support. When mounted between the body and the support, the pad may be preassembled between the seat and the abutment of the support or fitted on the syringe body before they are assembled.

When the syringe and the safety device are assembled, the pad, which is compressed between the collar of the syringe body and the seat of the syringe holder, exerts, due to contact with the flange and the seat, a resistant torque which prevents the rotation of the body relative to the support even when a sufficient torque to unscrew the cap or screw the needle holder is generated on the tip. This torque generated on the tip is transmitted between the tip and the body in particular because of the friction between these two elements. It is then easy for the user to unscrew the cap and screw the needle holder.

Such a skate eliminates the existing clearance in the state of the art between the seat and the flange and thereby prevents the syringe body from rotating relative to the syringe holder. The fact that it is made of an elastic material makes it easier to assemble the assembly, in particular to mount the flange more easily between the seat and the stop, despite the dispersion of its dimensions. Thus, the rotational locking of the body relative to the support is provided in a passive manner, that is to say that no specific gesture or action is required on the part of the user to lock the syringe in rotation.

The pad may have a coefficient of friction with at least one of the materials of the flange or seat greater than the coefficient of friction of the materials of the flange and seat between them. In this way, it is ensured that the resistive torque generated by the pad or pads is important and prevents rotation of the syringe body in the support, even when the user exerts a large force on the tip.

Note that the support can be immobilized in rotation relative to the sheath by any means, including the known means of EP 2 047 879, to further facilitate these operations.

In addition, the pad being independent of the tip, it is possible to immobilize in rotation any type of syringe during unscrewing of the plug, regardless of the tip that it carries.

The assembly according to the invention is also cheaper than a set according to the state of the art, which requires a complex conformation of the tip. Indeed, the only added element, the pad, does not necessarily have a complex conformation and does not have significant dimensions. As a result, its manufacture is inexpensive.

The invention may also include one or more of the features of the following list:

the shoe is formed by an annular ring. This embodiment is advantageous because it simplifies the manufacture and assembly of the assembly and therefore reduces manufacturing costs. The shape of the pad allows it to be fitted on the syringe body or placed on the device, between the seat and the abutment until the body is placed in the support, which ensures easy mounting of the device. together while avoiding the step of fixing the pad to the body or the support,

- At least one of the pad or the seat of the support has at least one projection. This also makes it easier to assemble the assembly and avoid damaging it. Indeed, as defined above, the collar of the syringe is locked axially in the support between the seat and at least one stop, usually a plurality of stops. The distance between the seat and the stops is determined. However, it is known that the manufacturing tolerances of the syringe body are quite large and that, as a result, the thickness of the collar can vary significantly. However, since it is desired to place the pad in compression between the support and the body for all the flange thicknesses, it is not advisable to increase the distance between the seat and the stop. For the thicker collars, the stop is therefore likely to undergo significant stress, once the flange inserted in the space between the stop and the seat, in response to the compression of the pad by the flange, and to be damaged even broken.

Thus, the embodiment in which the pad and / or seat have projections is very advantageous, because the thickness of the pad can be reduced while remaining in compression at the projections for all the collars. The compressive force exerted on the pad, as well as the force exerted in reaction on the stops, is then less important and the stop is not likely to be damaged, even for the thicker collars. All the collars, even the least thick, are nevertheless able to compress the pad so as to prevent rotation of the body.

A set in which the skate and the seat are both planes is however also possible,

in a particular embodiment, the pad has at least one protrusion, preferably projections distributed regularly, on a face in contact with the flange or with the seat. This embodiment is particularly simple to implement and is therefore advantageous,

the projection is formed on the seat, in a zone distinct from an area facing the abutment. The zone of the projection is for example interposed between two zones opposite two stops. Thus, the stresses on the abutment are minimized because of the presence of the pad, the pad being slightly compressed with respect to the abutment, while ensuring the immobilization in rotation of the syringe body, in particular by a greater compression of the skid in the areas facing the projection, regardless of the thickness of the collar of the syringe,

each of the projections of the seat and / or the pad is constituted by an element of the following list: a pin, a rib extending at least over a portion of the periphery of the pad or seat, or a radial rib,

the syringe body is made of glass or plastic and the syringe holder is made of plastic material. The plastics material of the body and / or the support is especially based on polyethylene (PE), polypropylene (PP), polycarbonate (PC), polystyrene (PS) polyester (ΡΕΤ, ΡΕΝ), styrenic polymers (SAN) acrylic polymers (PMMA ), copolymers (SMMA, MBS terpolymers), polyvinyl chloride (PVC), copolyester (PETG, PCTG, PCTA), acrylonitrile-butadiene-styrene (ABS), cyclic polyolefins, such as Cyclo Olefin Polymer (COP) and Cyclic Olefin Copolymers (COC), polyamide (PA), SB copolymer, styrene-ethylene-butylene-styrene (SEBS), polyether block amide (PEBA), poly (lactic-co-glycolic acid) (PLGA), polylactic acid (PLA), polyhydroxyalkanoates (PHA), polyhydroxybutyrate (PHB), cellulose propionate, cellulose acetate, as well as any mixture of these polymers and / or copolymers.

the pad is made of a thermoplastic or thermosetting elastomeric material, such as liquid silicone rubber (LSR), butyl rubber, halogenated or not, nitrile rubber, ethylene-propylene-diene thermoplastic monomer (EPDM), a mixture polypropylene and ethylene-propylene-diene monomer crosslinked (PP / EPDM), thermoplastic polyurethane (TPU) and cross-linked (PU), styrenic thermoplastics, and any mixture of these polymers and / or copolymers, the protective sheath and the syringe support comprise complementary means for securing in rotation between themselves about their axes, these means for securing in rotation being activated at least when the sheaths and support are in their relative position of disengagement from the needle. These means comprise at least one pair of complementary projection and groove formed on the syringe support and protection sleeve, in particular two diametrically opposite parts. The projection of the second means for securing in rotation is in particular formed on a proximal end of the syringe support and the groove of the second rotationally securing means is formed by a slot formed in a proximal end of the protective sheath. These means make it possible to further facilitate the operations of unscrewing the cap and screwing the needle holder.

The invention also relates to a safety device for a liquid injection syringe comprising a body of tubular general shape forming a reservoir for the liquid, the safety device comprising a member, called a syringe support, in which is arranged the syringe body, so that the syringe holder and the syringe body are axially secured, a collar of the syringe body located at a proximal end of the body being immobilized in translation between a peripheral support seat and a secondly at least one stop of the syringe support, the device being characterized in that it comprises a pad mounted between the seat and the stop and made of an elastic material, in particular elastomer material.

The friction coefficients of this material respectively with the material of the body (glass) and with the material of the support (plastic material, as defined above) is in particular greater than the coefficient of friction of the materials of the support and the body between them.

The invention will be better understood on reading the description which follows, with reference to the figures in which:

FIG. 1 is a sectional view of an assembly of a syringe and of a safety device for a syringe, before injection:

FIG. 2 is a sectional view of the assembly of FIG. 1, after the injection,

FIG. 3 is a perspective view of the proximal end of a half of all of FIGS. 1 and 2, from which the pusher has been removed,

FIG. 4 is a view of a pad of the assembly according to FIGS. 1 to 3,

FIG. 5A is a perspective view of the proximal end of the support of syringe of an assembly according to another embodiment of the invention,

FIG. 5B is a view of a pad that can be mounted on the syringe holder of FIG. 5A,

FIGS. 6 and 7 represent skids of an assembly constituting a variant of that of FIG. 1,

FIG. 8 is a perspective view of the proximal end of the syringe holder of an assembly of a third embodiment of the invention. FIGS. 1 to 3 show a syringe assembly, according to FIG. invention, designated by the general reference 10.

The assembly 10 comprises a conventional syringe 12 for injecting a liquid, in particular a medical liquid.

The syringe 12 comprises a tubular syringe body 14 forming a reservoir for the liquid, and made of glass. The body 14 includes an open proximal end 14P, provided with a flange 16, and a generally cone-shaped distal end 14D converging opposite the proximal end 14P.

The syringe 12 also comprises a pusher 18 mounted axially displaceable in the body 14 between a standby position, as shown in FIG. 1, and an end position of liquid injection, as represented in FIG.

The pusher 18, made for example of plastic material, has a proximal end 18P, external to the body 14, and a distal end 18D, internal to the body 14, carrying a conventional piston 20. The proximal end 18P of the pusher forms an end of maneuver this pusher.

The syringe 12 also comprises a fastener 22 provided with a plug 24 for closing the syringe, as shown in FIG. 1, or a needle holder 26 as represented in FIG. 2.

The attachment endpiece 22, of generally annular shape, has a proximal end fitted in a manner known per se on a surface complementary to the distal end 14D of the body 14. The attachment endpiece 22 also has a distal end intended to cooperate by screwing with the closure cap 24 or the needle holder 26.

The needle holder 26 carries a needle 28 capable of being protected by a removable cap fitted on the needle holder 26.

An axial channel 32, formed in the distal end 14D of the syringe body 14, allows the passage of liquid between this body 14 and the needle holder 26.

The assembly 10 also comprises a safety device 33.

The device 33 comprises a first member of generally tubular shape, called protective sheath 34, and a second organ of generally tubular shape, called syringe holder 36. This support 36 is housed in the sleeve 34 substantially coaxially with the latter.

The sheath 34 and support 36 are made for example of plastic. The sheath 34 and support 36 are axially displaceable with respect to each other between a first position, known as the clearance of the needle, as shown in FIG. 1, and a second position, referred to as retraction of the needle. needle, as shown in Figure 2.

The body 14 of the syringe is housed in a manner known per se in the support 36.

More particularly, the syringe body 14 is axially immobilized in the syringe holder 36 by snapping the flange 16 between a bearing seat 38 formed in the support 36 and a plurality of retractable locking stops 40 integral with the support 36.

The safety device 33 comprises means for retaining the support 36 in the needle release position relative to the sheath 34. These retaining means oppose the elastic force of return means comprising a thrust spring 42. 2, it can be seen that, in the position of disengagement of the needle, the spring 42 is housed in a groove 84 of generally annular shape, formed in this example in the proximal end of the sheath 34.

This groove 84 also provides axial and radial positioning of the spring 42.

As seen in FIG. 3, the retaining means comprise at least one pair of complementary retaining stops. A first retaining stop 44 is formed by the free end of an axial tongue 45 formed in a proximal end of the sheath 34. This tongue 45 is elastically deformable radially. The second retaining stop 46 is provided on a proximal end of the syringe holder 36. Preferably, the safety device 33 comprises two pairs of retaining stops 44, 46 diametrically opposed.

As seen in Figure 1, the assembly also comprises a pad 50 interposed between the flange 16 of the syringe body and the bearing seat 38 of the syringe holder. These elements will be described in more detail below.

Moreover, with the exception of aspects related to the invention which will be specified later, the operation of the safety device 33 is conventional, for example as described in FR-A-2 830 765.

For example, the safety device 33 also comprises means for locking the sleeve 34 in the retracted position of the needle 28. The sleeve 34 also carries external gripping means, not shown in the figures, intended to be grasped by the fingers of a user to inject the liquid through axial approach of the operating end 18P of the pusher and these gripping means.

The proximal end of the syringe assembly of FIG. 1 will now be described with reference to FIG.

The pad is made of an elastomeric material and is placed in compression between the seat 38 of the syringe holder and the flange 16 of the body. Because of the material of which it is constituted, its coefficients of friction respectively with the flange and with the support, are sufficient to generate a resistant couple blocking in rotation the syringe inside the safety device, notably superior to the coefficient of friction of the collar and support between them. Such a pad makes it possible to generate a resistant torque preventing rotation of the syringe body even if a user unscrews the cap 24 or screws a needle holder 26 into the endpiece 22.

The shoe 50 has a ring-shaped body. The shoe 50 also comprises a plurality of lugs 52 arranged on the body, as is also distinguished in FIG. 4. These lugs are disposed on a face of the body intended to be in contact with the flange 16 of the body 14 and also on a face of the body intended to be in contact with the seat 38. They are hemispherical and are evenly distributed on the ring 50. They make it possible to increase the friction of the pad with the collar without the thickness of the body being too great and then engenders too much stress on the stops 40.

The lugs 52 of the face intended to be in contact with the seat 38 are interposed between the lugs of the face intended to be in contact with the flange, as seen in FIG. 4.

The pad is generally pre-mounted on device 33 by wedging between the seat 38 and the abutments 40 of the syringe holder, before the syringe is mounted in a conventional manner on the device 33.

We will now comment on several variants of the set according to the figures

1 to 4.

In the following figures, the assembly is identical to that of Figures 1 to 4, with some details of constructions that will be described below. Identical references to those of the preceding figures (especially concerning FIG. 5) designate identical elements.

In FIG. 5A, the syringe holder 36 'comprises teeth 60 formed on the bearing seat 38. These teeth 60 are regularly distributed on the syringe holder, and are placed in a zone of the support that is distinct from an area located facing the abutment 40. They extend in a preferred direction corresponding to a transverse direction of the support. The assembly then comprises a shoe 62 forming a simple annular ring, as shown in Figure 5B, devoid of pins, and easier to manufacture. This pad may then be of the same thickness as the pad body of the previous embodiment. Despite the lack of pins on the pad, the proper operation of the device will still be assured. Indeed, the teeth can increase the compression of the ring and the resistive torque generated between the body 14 and the syringe holder 36 '.

In FIG. 6, the shoe 70 comprises an annular ring-shaped body and two peripheral ribs 72 extending around the periphery of the pad 70 at its two radial ends. The ribs 72 project from one side of the pad intended to be in contact with the flange 16 of the syringe body 14.

In FIG. 7, the pad 80 also comprises an annular ring-shaped body and bosses 82 projecting from the body relative to the two contact faces of the ring, respectively with the syringe body 14 and with the support 36 These bosses are parallelepipedic and extend over the entire radial dimension of the ring. They are regularly distributed all around the ring.

In FIG. 8, the syringe holder 36 "comprises a plurality of pads 84 arranged on the seat 38" of the syringe holder 36 ", these pads being of cylindrical shape and are attached to the support by one of their bases. is less than the width of the seat 38. They are located on a seat area that is not facing a stop 40 ". In this embodiment, the pads 84 are overmoulded on the seat 38 "and could also be assembled thereon.

Note that the assembly according to the invention is not limited to what has been described above. For example, the materials of the syringe bodies, safety devices or pad may be different from what has been described.

The shape of the security device may also vary with respect to what has been described. For example, the stops 40 and 44, 46 may be shaped differently or distributed differently from what has been described.

The assembly may also comprise a plurality of pads of smaller dimensions or of a shape different from that described.

The pad may also form an annular ring comprising other projections than those described or projections not evenly distributed. The projections may also be placed only on its face intended to be in contact with the syringe holder.

The pad can also be fixed, for example by gluing, welding, or overmolding, on the safety device or the syringe. It can also be fitted on the syringe before mounting it on the safety device.

The pads and / or projections, when integral with the safety device, can be placed opposite a stop for axial immobilization of the syringe body. The projections or pad may also not be evenly distributed on the body of the pad and / or the seat.

Claims

1. A syringe assembly (10) comprising a syringe (12) for injecting liquid and a safety device (33), characterized in that the syringe comprises a body (14) of generally tubular shape forming a reservoir for the liquid, the safety device comprising a member (36), called a syringe holder, in which the syringe body is arranged, so that the syringe holder and the syringe body are axially integral, the syringe body comprising at a proximal end a flange (16) immobilized in translation between on the one hand, a peripheral support seat (38) and, on the other hand, at least one stop of the syringe support, the assembly also comprising, interposed between the seat of the support and the flange of the body, at least one pad (50; 62; 70; 80; 84) in compression between the seat and the flange, the pad being made of an elastic material.

2. Assembly according to the preceding claim, wherein the pad (50; 62; 70; 80; 84) has a coefficient of friction with at least one of the materials of the flange or seat greater than the coefficient of friction of the materials of the collar and seat between them.

An assembly according to any one of the preceding claims, wherein the pad (50; 62; 70; 80) is formed by an annular ring.

4. An assembly according to any one of the preceding claims, wherein at least one of the pad (50) or the seat (38) of the support (36) has at least one projection (52; 60; 72; 82).

5. An assembly according to the preceding claim, wherein the pad has a plurality of projections (52, 72, 82), preferably distributed regularly on a face in contact with the flange and / or with the seat.

6. An assembly according to any one of the preceding claims, wherein the projection (60) is provided on the seat and is located in a separate area of a zone facing the abutment (40).

7. Assembly according to the preceding claim, wherein each of the projections of the seat and / or the pad is constituted by an element of the following list:

a lug (52), in particular hemispherical or parallelepipedal,

a rib (60; 72) extending at least over a portion of the periphery of the pad or seat,

- a radial rib (82).

8. An assembly according to any one of the preceding claims, in which the syringe body is made of glass or plastic and the syringe support is made of plastic, the plastic material of the support and / or the body being in particular based on polyethylene (PE), polypropylene (PP), polycarbonate (PC), polystyrene (PS) polyester (ΡΕΤ, ΡΕΝ), styrenic polymers (SAN) acrylic polymers (PMMA), copolymers (SMMA, MBS terpolymers), polyvinyl chloride (PVC), copolyester (PETG, PCTG, PCTA) , acrylonitrile-butadiene-styrene (ABS), cyclic polyolefins, such as Cyclo Olefin Polymer (COP) and Cyclic Olefin Copolymers (COC), Polyamide (PA), SB copolymer, Styrene-ethylene-butylene-styrene (SEBS), Polyether block amide (PEBA), poly (lactic-co-glycolic acid) (PLGA), polylactic acid (PLA), polyhydroxyalkanoates (PHA), polyhydroxybutyrate (PHB), cellulose propionate, cellulose acetate, as well as any mixture of these polymers and / or copolymers

An assembly according to any one of the preceding claims, wherein the pad (50; 62; 70; 80; 84) is made of a thermoplastic or thermosetting elastomeric material, such as liquid silicone rubber (LSR), rubber butyl, halogenated or otherwise, nitrile rubber, ethylene-propylene-diene thermoplastic monomer (EPDM), a blend of polypropylene and ethylene-propylene-diene cross-linked monomer (PP / EPDM), thermoplastic polyurethane (TPU) and crosslinked (PU), styrenic thermoplastics, as well as any mixture of these polymers and / or copolymers.

A safety device (33) for a syringe assembly as claimed in any one of the preceding claims, wherein the device comprises the shoe (50; 62; 70; 80; 84) mounted between the seat and the stop and made of an elastic material.