WO2006008086A1 - Safety kit for protecting the needle of a standard syringe, a glass syringe or a carpule - Google Patents

Safety kit for protecting the needle of a standard syringe, a glass syringe or a carpule Download PDF

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Publication number
WO2006008086A1
WO2006008086A1 PCT/EP2005/007729 EP2005007729W WO2006008086A1 WO 2006008086 A1 WO2006008086 A1 WO 2006008086A1 EP 2005007729 W EP2005007729 W EP 2005007729W WO 2006008086 A1 WO2006008086 A1 WO 2006008086A1
Authority
WO
WIPO (PCT)
Prior art keywords
sleeve
tongues
safety
sheath
rear
Prior art date
Application number
PCT/EP2005/007729
Other languages
French (fr)
Inventor
Sergio Restelli
Original Assignee
Sergio Restelli
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
Priority to ITMI20041471 priority Critical patent/ITMI20041471A1/en
Priority to ITMI2004A001471 priority
Application filed by Sergio Restelli filed Critical Sergio Restelli
Publication of WO2006008086A1 publication Critical patent/WO2006008086A1/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
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • 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
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • 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
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3261Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user triggered by radial deflection of the anchoring parts between sleeve and syringe barrel, e.g. spreading of sleeve retaining hooks having slanted surfaces by engagement with conically shaped collet of the piston rod during the last portion of the injection stroke of the plunger
    • 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
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3261Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user triggered by radial deflection of the anchoring parts between sleeve and syringe barrel, e.g. spreading of sleeve retaining hooks having slanted surfaces by engagement with conically shaped collet of the piston rod during the last portion of the injection stroke of the plunger
    • A61M2005/3264Trigger provided at the proximal end, i.e. syringe end opposite to needle mounting end
    • 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
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3271Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position

Abstract

A standard syringe (100) comprises a syringe body (101), a plunger (102) slidable inside the syringe body (101) and provided at the rear with a manually operable stem (120), an injection needle (111) mounted at the front end (110) of the syringe body (101). A safety kit (1) is applied to the standard syringe (100) and comprises a sheath (3) mounted fixedly on the syringe body (101), a sleeve (5) mounted slidably on the sheath (3) to pass from a retracted position of use to an advanced safety position, in which the needle (111) is protected by the sleeve (5), an operating element (2) mounted in the rear part (121) of the plunger stem, and a locking element (7) mounted on the sleeve (5). The kit can equally be applied to a Carpule (201).

Description

SAFETY KIT FOR PROTECTING THE NEEDLE OF A STANDARD SYRINGE, A GLASS SYRINGE OR A CARPULE

DESCRIPTION

The present invention refers to a safety kit that can be applied to a standard glass or plastic syringe, prefilled or otherwise, or to a Carpule, to turn the syringe and Carpule into a disposable safety type. For this purpose the safety kit has an automatic safety device to protect the needle of the standard syringe or Carpule once the injection has been performed.

A syringe generally comprises a cylindrical body open at the rear to receive a plunger. An internally hollow needle is mounted at the head of the syringe body.

A large number of medicinal substances are packaged in Carpules or capsules. A Carpule is made up of a substantially cylindrical body, one end of which has a narrower neck which is closed by a pierceable membrane. The liquid to be injected is held in the body of the Carpule by a slidable plunger.

In order to perform the injection, the Carpule is fitted into a syringe or device suitable to receive it, and a needle which pierces the membrane of the Carpule is mounted so that operation of a stem causes the liquid to be expelled.

Because of health regulations and to avoid transmission of infectious diseases, syringes and Carpules must generally be used once and then discarded. For this reason, there is a growing market demand for disposable syringes adapted to prevent further use.

Moreover, both syringes and Carpules generally present drawbacks from the point of view of safety. In fact, once the syringe has been used, the needle remains exposed at the head of the syringe body, with the risk of injuries or accidental needle sticks.

To overcome these drawbacks, plastic disposable syringes having safety devices to cover the needle are available on the market. These safety devices, in the form of a sleeve slidably mounted on the syringe body, generally adapt to specially dedicated syringes and not to standard syringes. That is to say, they require special syringes to be designed or existing syringes to be structurally modified, with obvious drawbacks, also and above all from an economic point of view.

EP 1 334 740 describes a safety device for syringes, particularly pre-filled glass syringes. In the practical realization of such a device it has proved extremely problematical to achieve locking thereof in the safety position, that is with the needle covered, once the injection has been performed.

The main object of the present invention is to overcome the drawbacks encountered in the solution according to EP 1 334 740, by providing a safety kit for syringes and Carpules that ensures sure and reliable operation and secure locking of the needle covering device, once the injection has been performed.

Another object of the present invention is to provide a safety kit that is versatile and suitable to be applied to any type of standard syringe in glass or plastic, pre-filled or otherwise, Carpules and the like.

Another object of the invention is to provide such a safety kit that is able to make a standard syringe and Carpule safe and disposable and prevent accidental injury or tampering after use thereof.

Yet another object of the invention is to provide such a safety kit for a standard syringe that is inexpensive and simple to produce and assemble.

These objects are achieved according to the invention with the characteristics listed in appended independent claim 1.

Advantageous embodiments of the invention are apparent from the dependent claims.

A standard syringe comprises a syringe body hollow on the inside and open at the front and rear, a plunger slidable inside the syringe body and provided at the rear with a manually operable stem and an injection needle mounted at the fore end of the syringe body.

To make this syringe into a safety syringe, according to the invention, a kit is provided comprising:

- a sheath mounted fixedly on the syringe body, - a sleeve mounted slidably on the sheath to pass from a retracted position of use in which the needle protrudes from the sleeve to perform the injection to an advanced safety position in which the needle is protected by the sleeve,

- an operating element mounted in the rear part of the stem of the plunger, and - a locking device mounted on the sleeve.

The sleeve comprises:

- first locking means cooperating with complementary locking means provided at the rear in the sheath to lock the sleeve in the retracted position of use, and - second locking means cooperating with complementary locking means provided in the front part of the sheath to lock the sleeve in the advanced safety position.

When the plunger reaches the end of the injection stroke, the operating element cooperates with the first locking means of the sleeve, to allow them to disengage and the sleeve to move from the retracted position of use to the advanced safety position.

The locking device maintains the second locking means in a position suitable to engage with the front part of the sheath, when the sleeve is in the advanced safety position, thus ensuring secure covering of the needle.

The advantages of the kit for a safety syringe according to the invention are obvious in that it allows a standard syringe to be made into a safety syringe, providing the possibility of covering the needle with the sleeve, once the injection has been performed.

The same occurs for protection of the needle of a Carpule.

Further characteristics of the invention will be apparent from the detailed description that follows, referring to purely exemplary and therefore non-limiting embodiments thereof, illustrated in the appended drawings, in which: Figure 1 is a perspective view of a standard syringe in which the elements of the safety kit according to the invention are illustrated in an exploded view;

Figure 2 is an axial sectional view illustrating two elements of the safety kit assembled and a third element exploded;

Figure 3 is an axial sectional view illustrating the three elements of the safety kit of Figure 2 assembled;

Figure 4 is a perspective view illustrating the safety kit according to the invention assembled on the standard syringe of Figure 1, so as to form a safety syringe;

Figure 5 is an axial sectional view of the safety syringe of Figure 4 in which the standard syringe has not been sectioned;

Figure 6 is an axial sectional view of the safety syringe of Figure 4, but in the position at the end of the injection stroke; and

Figure 7 is an axial sectional view of the safety syringe of Figure 4, but in the safety position;

Figure 8 is a perspective view illustrating the safety kit according to the invention applied to a Carpule.

A safety kit according to the invention, denoted as a whole with reference numeral 1, suitable to be applied to a standard syringe 100 so as to obtain a disposable safety syringe, is described with the aid of Figures 1-7.

In this description specific reference will be made to an orientation of the syringe such that the front part corresponds to the one where the needle is disposed and the rear part to the opposite one.

With reference to Figure 1, the standard syringe 100 comprises a syringe body 101 made of plastic or glass. The syringe body 101 is substantially cylindrical in shape, is hollow on the inside and has a cylindrical chamber open at the front and rear. The syringe body 101 has at its front end a head 110 in which a needle carrier 114 which supports an injection needle 111 is mounted.

A front needle-covering cap 113 which covers the injection needle 111 is mounted in the head 110 of the syringe body. The syringe body 101 has, in its rear end, a flange 112 which protrudes radially therefrom to facilitate gripping by the user.

A plunger 102 made of rubber can slide axially with a tight seal in the cylindrical chamber of the syringe body 101. The plunger 102 is supported at the front end by a stem 120 made of plastic. The stem 120 has, at its rear end, a disc-shaped flange 121 disposed outside the syringe body 101 to able to be operated manually by the user.

The safety kit 1 comprises a rear cap or operating element or opening cone 2, a sheath 3, a spring 4, a needle-covering sleeve 5 and a locking device 7. The rear cap or opening cone 2 is applied on the rear flange 121 of the stem 120. The sheath 3 is mounted on the syringe body 101. The sleeve 5 is mounted on the sheath 3 with the spring 4 interposed therebetween. The locking device 7 is applied on the sleeve 5.

The rear cap 2 has a cylindrical body 20 hollow on the inside and open at the front to receive the disc-shaped flange 121 of the plunger stem. Four flexible tongues 21 arranged in diametrically opposite positions and protruding inward are formed in the body 20 of the rear cap. In this manner, as shown in Figure 5, when the rear cap 2 is applied to the disc-shaped flange 121, the tongues 21 bend outwards through the action of the flange 121 and return elastically to the initial position so as to lock the cap 2 to the flange 121.

The rear cap 2 has a frustoconical or tapered crown 22 at the front which defines a flat, annular front abutment surface 23.

The sheath 3 has a substantially cylindrical body open at the front and rear and having an inside diameter substantially equal to or slightly greater than the outside diameter of the syringe body 101 so as to be able to be force fitted thereon. The sheath 3, at its rear end, comprises a collar 30 which protrudes radially outward so as to define an annular abutment surface 35 (Figure 2).

Two teeth 31 which protrude radially outward in diametrically opposite positions are provided on the collar 30. Two longitudinal slots 32 disposed in diametrically opposite positions are provided on the side surface of the sheath 3, aligned with the teeth 31. As shown also in Figure 2, each longitudinal slot 32 defines a rear abutment surface 33 and a front abutment surface 34 situated at the end of a tapering or bevel 134.

The sheath 3 has at the front, in its inside surface, longitudinal ribs 135 protruding inwards to elastically grip the syringe body 101, when the sheath 3 is forced thereon, so as to firmly lock the sheath 3 on the syringe body 101. As shown in Figure 5, the sheath 3 is forced onto the syringe body 101 until the rear edge of the collar 30 abuts against the flange 112 of the syringe body.

The spring 4 is a helicoidal compression spring which is fitted over the sheath 3 so that its front end abuts against the abutment surface 35 of the collar 30 of the sheath.

The sleeve 5 is substantially cylindrical in shape, hollow on the inside and open at the front and rear. The sleeve 5 has an inside diameter slightly greater than the outside diameter of the sheath 3 so that it can be fitted slidably thereon.

The sleeve 5 has a cylindrical rear part 50 with a larger diameter and a cylindrical front part 51 with a smaller diameter. As shown in Figure 2, the rear cylindrical part 50 with a larger diameter defines on the inside an annular abutment surface 52 able to abut against the front end of the spring 4. On the other hand, the front part 51 with a smaller diameter defines on the inside an annular abutment surface 62 able to abut against the front edge of the sheath 3.

In this manner, as shown in Figure 2, the helicoidal compression spring 4 wound around the sheath 3 is interposed between the annular abutment surface 35 of the collar 30 of the sheath 3 and the annular abutment surface 52 of the sleeve 5.

As shown better in Figure 1, two rear tongues 53 are formed in the side wall of the part 50 of the sleeve with the larger diameter. The rear tongues 53 are disposed longitudinally in diametrically opposite positions and are flexible. Each rear tongue 53 has a rectangular slot 54 within which the respective tooth 31 of the collar 30 of the sheath snap engages, so as to firmly retain the sleeve 5 on the sheath 3 against the pushing action of the spring 4.

Each rear tongue 53 is defined by two parallel longitudinal notches 55, which reach the end of the part with the larger diameter 50. In this manner each rear tongue 53 can bend radially outward. Furthermore, each rear tongue 53 has a rear part which protrudes beyond the rear end of the part 50 with the larger diameter. The rear end of each tongue 53 has a tapered surface 56 able to cooperate with the tapered surface 22 of the rear cap 2.

At the rear end of the part with the greater diameter 50, a flange 65 protrudes radially to facilitate gripping by the user. The rear flange 65 of the sleeve is not present in the area where the rear tongues 53 are situated so as not to interfere with them. The flange 65 of the sleeve has in its rear wall an annular abutment surface against which the rear abutment flange 112 of the syringe body 101 abuts.

In the side wall of the body of the sleeve 5 two central tongues 57 are formed. The central tongues 57 are disposed longitudinally in diametrically opposite positions and are flexible. Each central tongue 57 is defined by a substantially U-shaped notch 58, so as to be able to bend elastically. The U-shaped notch 58 has at the front a rectangular seat 69. Each central tongue 57 has an outward protruding tooth 59.

Again in the side wall of the body of the sleeve 3 two front tongues 60 are formed. The front tongues 60 are disposed longitudinally in diametrically opposite positions. Each front tongue 60 is defined by a substantially U-shaped notch 61, so as to be able to bend elastically. On the outside surface of the front tongues there are respective protrusions or teeth 65 which protrude outward.

The central tongues 57 are opposed to the front tongues 60. Each central tongue 57 has an end surface 66 opposed to the end surface 67 of the respective front tongue 60.

The locking device 7 is in the form of a cylindrical sleeve hollow on the inside, open at the front and rear and having an inside diameter slightly greater than the outside diameter of the body of the sleeve 5. The locking device 7 has two flexible circumferential tongues 70 formed by means of two U-shaped notches 71 on the side wall of the locking cylinder 7, and two longitudinal tongues 170 formed by means of respective pairs of longitudinal notches 171.

On the inside surface of the tongues 70 respective teeth 72 having a tapered surface 73 which defines a radial abutment surface 74 are provided (Figure 2).

When the locking device 7 is fitted on the sleeve 5, the inner surface of the locking device cooperates with the protrusions 68 and 59 respectively of the front tongues 60 and central tongues 57. hi particular the longitudinal flexible tongues 170 of the locking device 7 act on the protrusions 68 of the front tongues 60. hi this manner the front tongues 60 and the central tongues 57 bend elastically inward so that their ends 67 and 66 enter the longitudinal slots 32 of the sheath 3 (Figure 5).

When the rear end edge of the safety device 7 goes into abutment against the part with the larger diameter 50 of the sleeve 5, each tooth 71 of the circumferential tongues 70 of the safety device goes beyond the portion of wall which divides the front tongues 60 from the central tongues 57 of the sleeve 5 and settles into the seat 69 of U-shaped notch 58 of the central tongue 57. In this situation, as shown in Figure 3, the locking device 7 cannot be removed from the sleeve 5, because the abutment surface 74 of the teeth 72 of the circumferential tongues of the safety device is in abutment against the wall of the seat 69 of the sleeve 5. Thus the locking device 7 remains locked in position on the sleeve 5 maintaining the front tongues 60 and the central tongues 57 bent inward.

At this point, as shown in Figures 4 and 5, the safety kit is assembled on the standard syringe 100 so as to form a safety syringe ready for use.

Operation of the safety syringe according to the invention will now be described.

With reference to Figures 4 e 5, in an initial condition the spring 4 is compressed between the annular abutment surface 35 of the collar 30 of the sheath 3 and the annular abutment surface 52 of the sleeve 5. The teeth 31 of the collar of the sheath 3 are engaged in the slots 54 of the rear tongues 53 of the sleeve, avoiding any axial movement of the sheath 3 and the syringe body 101 assembly with respect to the sleeve 5. Furthermore, the locking device 7 maintains the front and central tongues 60 and 57 bent inward in the longitudinal slots 32 of the sheath 3.

The chamber of the syringe body 101 is filled or is pre-filled with a solution for injection. Thus, when the injection is performed and the plunger 102 reaches the end of its stroke in the chamber of the syringe body 101, as shown in Figure 6, the tapered surface 22 of the rear cap 2 cooperates with the tapered surface 56 of the rear end of the rear tongues 53 of the sleeve 5 causing inward radial bending thereof.

Consequently the teeth 31 of the collar of the sheath 3 disengage from the slots 54 of the tongues 53 and the sleeve 5 is no longer firmly constrained to the sheath 3 and syringe body 101 assembly. As a result, as shown in Figure 7, the spring 6, which was compressed, is released, lengthening, pushing the sleeve 5 and causing forward axial sliding thereof with respect to the sheath integral with the syringe body, until the front tongues 60 of the sleeve 5 pass the front end of the sheath 3, and the abutment surface 66 of the central tongues 57 abuts against the front abutment surface 34 of the longitudinal slots 32 of the sheath.

Passing of the front end of the sheath 3 by the tongues 60 is made possible by bevels 134 provided in the sheath 3, which form an invitation for sliding of the tongues 60, and to the simultaneous, temporary yielding of the tongues 60 of the sleeve 5 and of the longitudinal flexible tongues 170 of the locking device 7. Said axial movement of the sleeve 5 with respect to the sheath assembly integral with the syringe body is guided, since the front tongues 60 and the central tongues 57 of the sleeve slide in the respective longitudinal slots 32 of the sheath.

hi this situation, the needle 111 is protected in the safety position inside the sleeve 5. It should be noted that when the sleeve 5 is in the safety position, any axial movement of the sleeve 5 with respect to the sheath 3 and syringe body assembly is prevented, hi fact the front end of the sheath 3 abuts against the rear end 67 of the front tongues 60, which are again bent inward, and the front abutment surfaces 34 of the longitudinal slots 32 of the sheath abut against the front abutment surfaces 66 of the tongues 57, also bent inward.

This has been achieved in a simple and inexpensive manner thanks to the use of the locking device 7, tubular in shape, which, when fitted over the sleeve, acts on the tongues 60, 57, keeping them constantly bent toward the inside of the longitudinal slots 32 of the sheath 3.

The present embodiment of the invention has been described with specific reference to a standard syringe 100. However, the safety kit 1 can also be applied to a Carpule 201, as illustrated in Figure 8.

The Carpule 201 comprises a vial or capsule made of plastic or glass. The body of the Carpule 201 is substantially cylindrical in shape, is hollow on the inside and has a cylindrical chamber designed to contain the medicinal solution for injection. The Carpule body 201 has at its front end a smaller-diameter neck and a head 210, provided with a stopper or tight, pierceable membrane. The Carpule 201 is provided with an injection needle 211 provided with two tips 213, 213' at its ends. The needle 211 is supported by a needle-holder 214.

The tip 213' pierces the membrane 210 of the head of the Carpule to come into contact with the medicinal solution inside the Carpule and the needle-holder 214 is locked tightly in the cap of the head 210 of the Carpule. Clearly the needle-holder 214 can be mounted integrally with the head 210 of the Carpule.

A plunger 202, generally made of rubber, is tightly mounted slidably inside the rear part of the carpule 201. A seat 203 able to receive a protrusion 204 formed in the front end of a stem 220 is provided in the rear part of the plunger 202.

The stem 220 has at its rear end an opening cone 2, like that previously described with reference to the syringe 100, which serves to operate the safety mechanism of the kit. The opening cone 2 can be made in a single body with the stem 220, as illustrated in Figure 8, or can be a separate element forming part of the safety kit 1 and be mounted on the rear flange of the stem 220.

The protrusion 204 of the stem couples in a screwing or snap fastening engagement inside the seat 203 of the plunger 202. Clearly the plunger 202 can already be made integral with the front end of the stem 220. In fact the Carpule 201 can be pre-filled or empty.

To make the Carpule 201 safe it is inserted inside the sheath 3, so that the longitudinal ribs 135 of the sheath grip on the head 210 of the Carpule to lock it firmly inside the sheath 3 and make it integral therewith. Then, as described previously, the spring 4 and the sheath 3 are inserted inside the sleeve 5 and the locking device 7 is applied to the sleeve 5. In this manner the Carpule 201 is made like an automatic safety syringe.

The needle 211 can be mounted in the head of the Carpule before or after insertion of the Carpule 201 inside the sheath 3. Alternatively, the needle-carrier 214 can be mounted integrally in the head of the sheath 3, so that when the Carpule 201 is inserted into the sleeve 3, the membrane of its head is pierced by the second tip 213' of the needle.

Numerous variations and modifications of detail within the reach of a person skilled in the art can be made to the present embodiment of the invention and in any case come within the scope of the invention as set forth in the appended claims.

Claims

1. A safety kit (1) that can be applied to protect the needle of a standard glass or plastic syringe or Carpule, comprising: a body (101; 201) hollow on the inside to contain the medicinal liquid for injection, a plunger (102; 202) slidable with a tight seal inside said hollow body (101; 201), - a stem (120; 220) able to be made integral with the rear part of the plunger which can be manually operated outside the body (101; 201) by means of the rear end (121; 221) thereof, and an injection needle (111; 211) able to be mounted at the front end (110; 210) of the body (101; 201), said safety kit comprising: a sheath (3) integrally mountable on said syringe body (101), a sleeve (5) mounted slidably on said sheath (3) to pass from a retracted position of use in which the needle (111; 211) protrudes forward therefrom to be able to perform the injection to an advanced safety position in which the needle (111 ; 211) is protected by the sleeve (5), said sleeve (5) comprising:
- first locking means (53, 54) cooperating with complementary locking means (31) provided at the rear in said sheath to lock said sleeve (5) in the retracted position of use, second locking means (60, 57) cooperating with complementary locking means (34) provided in the front part of said sheath (3) to lock said sleeve (5) in the advanced safety position, spring means (4) interposed between said sleeve (5) and said sheath (3), an operating element (2) mounted in the rear part (121; 221) of the stem (120; 220) of the plunger to cooperate with said first rear locking means (53) of the sleeve, when the plunger (102; 202) reaches the end of the injection stroke to allow disengagement of the first rear locking means (53) and movement of said sleeve (5) from the retracted position of use to the advanced safety position, and a locking device (7) mounted on said sleeve (5) to maintain said locking means (60, 57) in a position able to engage with the front part of said sheath (3), when the sleeve is in the advanced safety position.
2. A safety kit (1) according to claim 1, characterized in that one end of said spring means (4) is in abutment against an annular abutment surface (52) defined between a part with a larger diameter (50) and the body of said sleeve and the other end of said spring means (4) is in abutment against an annular abutment surface (35) defined by a collar (30) protruding outward from the rear end of said sheath (3).
3. A safety kit (1) according to any one of the preceding claims, characterized in that said first locking means (53) of the sleeve comprise two rear elastic tongues (53) formed longitudinally in the rear part of the side wall of said sleeve (5) and provided with respective slots (54) able to receive two teeth (31) protruding radially outward, in diametrically opposite directions, from the rear part of said sheath.
4. A safety kit (1) according to claim 3, characterized in that each of said rear tongues (53) of the sleeve is defined by two longitudinal parallel notches (55) formed in said side wall of the sleeve, up to rear end of the sleeve, and the rear end of said tongues (53) protrudes rearward beyond the rear end of the sleeve (5).
5. A safety kit (1) according to claim 3 or 4, characterized in that said operating element comprises a cap or opening cone (2) that can be applied to the rear end (121; 221) of the stem of the plunger and provided with a frustoconical crown (22) cooperating with said rear tongues (53) of the sleeve, when the plunger (102; 202) reaches the end of the injection stroke, so as to make them diverge outwardly to disengage said teeth (31) of the sheath from said slots (54) of the rear tongues.
6. A safety kit (1) according to any one of the preceding claims, characterized in that said second locking means comprise a first pair of flexible central tongues (57), provided longitudinally in diametrically opposite positions in the central part of the side wall of said sleeve (4), and a second pair of front flexible longitudinal tongues (60) opposed to said central tongues (57), each central tongue (57) and front tongue (60) having a protrusion (59, 68) protruding outward and cooperating with said locking device (7) so as to maintain the central tongues (57) and the front tongues (60) bent inwards with the ends (66, 67) opposed.
7. A safety kit (1) according to claim 6, characterized in that said sheath (3) comprises a pair of longitudinal grooves (32) disposed in diametrically opposite positions inside which said inwardly bent central tongues (57) and front tongues (60) of the sleeve, bent inward, act so as to guide the sleeve (5) when it passes from its retracted position of use to its advanced safety position.
8. A safety kit (1) according to claim 6 or 7, characterized in that said locking device (7) comprises a pair of longitudinal flexible tongues (170) able to act on said protrusions (68) of said front tongues (60) provided in the sleeve (5), to bend them inwards.
9. A safety kit (1) according to any one of the preceding claims, characterized in that said locking device (7) also comprises a pair of circumferential tongues (70) which have respective teeth (71) protruding inward and able to engage within respective seats (69) formed in said sleeve (5) to lock the locking device (7) on the sleeve (5).
10. A safety kit (1) according to claims 6, 8 and 9, characterised in that each central tongue (57) of the sleeve is formed by a respective substantially U- shaped notch (58) made in the front central part of the side wall of the sleeve, each front tongue (60) of the sleeve is formed by a respective substantially U-shaped notch (61) formed in the front part of the side wall of the sleeve and opposed to the U- shaped notch (58), each circumferential tongue (70) of the locking device (7) is formed by means of a U-shaped notch (71) in the side wall of the locking device (7) and each longitudinal flexible tongue (170) of the locking device (7) is formed by means of a respective pair of longitudinal notches (171).
11. A safety kit (1) according to any one of the preceding claims, characterised in that said operating element or opening cone (2) is formed in a single body with the stem (120; 220) of the plunger of said syringe or said Carpule.
12. A safety kit (1) according to any one of the preceding claims, characterised in that said Carpule (201) comprises a pierceable front membrane and said needle (211) of the Carpule comprises a double tip (213, 213') wherein the first tip (213) is able to make the injection and the second tip (213') is able to pierce the stopper of the Carpule (201) to come into contact with the medicinal liquid contained in the Carpule.
13. A disposable safety syringe (100), made of glass or plastic, pre-fϊlled or otherwise, characterised in that it comprises a safety kit (1) according to any one of the preceding claims.
14. A disposable safety Carpule (201), made of glass or plastic, prefilled or otherwise, characterised in that it comprises a safety kit (1) according to any one of claims 1 to 12, able to make said Carpule into an automatic safety syringe.
PCT/EP2005/007729 2004-07-21 2005-07-15 Safety kit for protecting the needle of a standard syringe, a glass syringe or a carpule WO2006008086A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
ITMI20041471 ITMI20041471A1 (en) 2004-07-21 2004-07-21 Safety kit for standard related to disposable safety syringe syringe
ITMI2004A001471 2004-07-21

Publications (1)

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WO2006008086A1 true WO2006008086A1 (en) 2006-01-26

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WO (1) WO2006008086A1 (en)

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GB2448160A (en) * 2007-04-04 2008-10-08 Northcroft Golf Ltd Item having attachment means
EP2022523A1 (en) 2007-08-02 2009-02-11 Arte Corporation Combined container-syringe with needle protection
EP1970086A3 (en) * 2007-03-15 2010-02-24 Bristol-Myers Squibb Company Injector for use with pre-filled syringes and method of assembly
US7713135B2 (en) 2005-10-07 2010-05-11 Northcroft Golf Limited Golf pitch mark repairer
WO2010096511A1 (en) 2009-02-17 2010-08-26 Safety Syringes, Inc. Improved plunger rod head for activating needle safety device
EP2213320A3 (en) * 2009-01-30 2011-11-02 Arte Corporation Combined container-syringe
FR2971424A1 (en) * 2011-02-14 2012-08-17 Marc Brunel Safety syringe
EP2497510A1 (en) * 2009-11-05 2012-09-12 Arte Corporation Syringe-cum-container
EP2623145A1 (en) * 2012-02-03 2013-08-07 Q Stat Pty Ltd Retractable needle apparatus
US8834419B2 (en) 2008-06-19 2014-09-16 Cilag Gmbh International Reusable auto-injector
US8845594B2 (en) 2008-06-19 2014-09-30 Cilag Gmbh International Auto-injector with filling means
US8939958B2 (en) 2008-06-19 2015-01-27 Cilag Gmbh International Fluid transfer assembly for a syringe
US9028453B2 (en) 2008-06-19 2015-05-12 Cilag Gmbh International Reusable auto-injector
US9028451B2 (en) 2006-06-01 2015-05-12 Cilag Gmbh International Injection device
US9072833B2 (en) 2006-06-01 2015-07-07 Cilag Gmbh International Injection device
US9358346B2 (en) 2005-08-30 2016-06-07 Cilag Gmbh International Needle assembly for a prefilled syringe system
US9649441B2 (en) 2005-04-06 2017-05-16 Cilag Gmbh International Injection device (bayonet cap removal)
US9675757B2 (en) 2004-05-28 2017-06-13 Cilag Gmbh International Injection device
US9675758B2 (en) 2004-05-28 2017-06-13 Cilag Gmbh International Injection device
US9682194B2 (en) 2008-06-19 2017-06-20 Cilag Gmbh International Re-useable auto-injector with filling means
US9731080B2 (en) 2005-04-06 2017-08-15 Cilag Gmbh International Injection device
US9757520B2 (en) 2006-06-01 2017-09-12 Cilag Gmbh International Injection device
US9770558B2 (en) 2005-09-27 2017-09-26 Cilag Gmbh International Auto-injection device with needle protecting cap having outer and inner sleeves
EP2108394B1 (en) * 2006-08-28 2017-12-06 Poly Medicure Ltd. Protector cover assembly
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US9895493B2 (en) 2004-05-28 2018-02-20 Cilag Gmbh International Injection device
US9675757B2 (en) 2004-05-28 2017-06-13 Cilag Gmbh International Injection device
US9675758B2 (en) 2004-05-28 2017-06-13 Cilag Gmbh International Injection device
US9649441B2 (en) 2005-04-06 2017-05-16 Cilag Gmbh International Injection device (bayonet cap removal)
US9731080B2 (en) 2005-04-06 2017-08-15 Cilag Gmbh International Injection device
US9358346B2 (en) 2005-08-30 2016-06-07 Cilag Gmbh International Needle assembly for a prefilled syringe system
US9770558B2 (en) 2005-09-27 2017-09-26 Cilag Gmbh International Auto-injection device with needle protecting cap having outer and inner sleeves
US7713135B2 (en) 2005-10-07 2010-05-11 Northcroft Golf Limited Golf pitch mark repairer
US9757520B2 (en) 2006-06-01 2017-09-12 Cilag Gmbh International Injection device
US9072833B2 (en) 2006-06-01 2015-07-07 Cilag Gmbh International Injection device
US9028451B2 (en) 2006-06-01 2015-05-12 Cilag Gmbh International Injection device
EP2108394B1 (en) * 2006-08-28 2017-12-06 Poly Medicure Ltd. Protector cover assembly
EP1970086A3 (en) * 2007-03-15 2010-02-24 Bristol-Myers Squibb Company Injector for use with pre-filled syringes and method of assembly
GB2448160A (en) * 2007-04-04 2008-10-08 Northcroft Golf Ltd Item having attachment means
EP2022523A1 (en) 2007-08-02 2009-02-11 Arte Corporation Combined container-syringe with needle protection
US9682194B2 (en) 2008-06-19 2017-06-20 Cilag Gmbh International Re-useable auto-injector with filling means
US8834419B2 (en) 2008-06-19 2014-09-16 Cilag Gmbh International Reusable auto-injector
US8939958B2 (en) 2008-06-19 2015-01-27 Cilag Gmbh International Fluid transfer assembly for a syringe
US9028453B2 (en) 2008-06-19 2015-05-12 Cilag Gmbh International Reusable auto-injector
US8845594B2 (en) 2008-06-19 2014-09-30 Cilag Gmbh International Auto-injector with filling means
US8684977B2 (en) 2009-01-30 2014-04-01 Arte Corporation Combined container-syringe
EP2213320A3 (en) * 2009-01-30 2011-11-02 Arte Corporation Combined container-syringe
WO2010096511A1 (en) 2009-02-17 2010-08-26 Safety Syringes, Inc. Improved plunger rod head for activating needle safety device
EP2398535A1 (en) * 2009-02-17 2011-12-28 Safety Syringes, Inc. Improved plunger rod head for activating needle safety device
EP2398535A4 (en) * 2009-02-17 2014-10-15 Safety Syringes Inc Improved plunger rod head for activating needle safety device
EP2497510A1 (en) * 2009-11-05 2012-09-12 Arte Corporation Syringe-cum-container
EP2497510A4 (en) * 2009-11-05 2013-12-25 Arte Corp Syringe-cum-container
FR2971424A1 (en) * 2011-02-14 2012-08-17 Marc Brunel Safety syringe
WO2012110715A1 (en) * 2011-02-14 2012-08-23 Marc Brunel Safety single-use injection device
EP2623145A1 (en) * 2012-02-03 2013-08-07 Q Stat Pty Ltd Retractable needle apparatus

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