WO2006111859A1 - Injection set and injection assistance device - Google Patents

Injection set and injection assistance device Download PDF

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Publication number
WO2006111859A1
WO2006111859A1 PCT/IB2006/001333 IB2006001333W WO2006111859A1 WO 2006111859 A1 WO2006111859 A1 WO 2006111859A1 IB 2006001333 W IB2006001333 W IB 2006001333W WO 2006111859 A1 WO2006111859 A1 WO 2006111859A1
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WO
Grant status
Application
Patent type
Prior art keywords
injection
sleeve
body
sleeve tube
characterized
Prior art date
Application number
PCT/IB2006/001333
Other languages
French (fr)
Inventor
Eric Olive
Frédéric PEROT
Original Assignee
Becton Dickinson France
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

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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
    • A61M5/46Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion
    • 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
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033Spring-loaded one-shot injectors with or without automatic needle insertion
    • 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
    • A61M5/3257Semi-automatic sleeve extension, i.e. in which the triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means
    • A61M5/326Fully automatic, i.e. in which the triggering 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
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006Having specific accessories
    • A61M2005/2013Having specific accessories triggering of discharging means by contact of injector with patient body
    • 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
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/206With automatic needle insertion
    • 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
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M2005/31518Piston or piston-rod constructions, e.g. connection of piston with piston-rod designed to reduce the overall size of an injection device, e.g. using flexible or pivotally connected chain-like rod members
    • 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
    • A61M5/3257Semi-automatic sleeve extension, i.e. in which the triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means
    • A61M5/326Fully automatic, i.e. in which the triggering does not require a deliberate action by the user
    • A61M2005/3267Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
    • 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
    • A61M5/3287Accessories for bringing the needle into the body; Automatic needle insertion
    • 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
    • A61M5/50Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5066Means for preventing re-use by disconnection of piston and piston-rod

Abstract

The present invention relates to an injection assistance device (1) comprising a body (2), an injection needle (7) and one piston plunger (26), a hollow sleeve (4) receiving the body (2) said body being movable between an initial position and an insertion position in which the needle (7) is exposed by a length L, a sleeve tube (6) able to move with respect to the sleeve (4), the sleeve tube (6) comprising coupling means (46) for connecting a region for holding (8) to the piston plunger (26) or to the body (2), from the initial position to the insertion position so as to allow the insertion with one hand in one uni-directional axial movement, said sleeve tube (6) being formed of several coupling elements (32, 36; 43) provided with shapes that collaborate with those of the piston plunger (26), and able to connect the said sleeve tube (6) to the said piston (26) and to disengage by deformation, to release the said piston (26), and partly forming the said coupling means.

Description

INJECTION SET AND INJECTION ASSISTANCE DEVICE

The present invention relates to an injection assistance device for an injection device and to an injection set provided with the said injection assistance device, these devices making it easier and safer to inject a product into an injection site.

In this application, the distal end of a component or of a device is to be understood as meaning the end furthest from the user's hand and the proximal end is to be understood as meaning the end closest to the user's hand. Likewise, in this application, the "distal direction" is to be understood as meaning the direction of injection, and the "proximal direction" is to be understood as meaning the opposite direction to the direction of injection.

In order to administer a medicinal product by injection into a body, particularly the human body, there are various possible routes depending on the place in the body at which the said product is to be injected: thus, the product may be injected intravenously, intramuscularly, subcutaneously, into a joint, or else intradermally. In many of these cases, and, particularly when injecting subcutaneously, the depth to which the needle is inserted and therefore at which the product is injected is particularly significant.

Thus, it is possible to observe an adverse immunological reaction if, for example, a product that should have been injected into the subcutaneous tissues is finally injected into the intradermal tissues.

The operation of injecting a product using a syringe is particularly delicate.

As far as subcutaneous injection is concerned, there are various injection techniques currently used. Some users prefer to pinch the skin before inserting the needle, others prefer not to, and still others angle the syringe before inserting it into the skin, it is therefore possible for this angle to vary from one user to another. The result of all this is that the depth to which the needle is inserted and therefore at which the product is injected may itself also vary, with the unpleasant consequences mentioned above.

Furthermore, in this kind of operation, it is also important to avoid any needlestick injury due to the exposed needle, whether this be before or after injection. It is also important after use to be able to ensure that the syringe cannot be used again.

In addition, to limit the apprehension felt by the patient, particularly in the case of injections administered by the patient himself, it is desirable for the injection device not to look like a conventional syringe and/or for the needle not to be visible or to be visible only a little prior to insertion.

Finally, injecting a product using traditional injection devices generally entails at least two manual steps. For example, in the case of syringes, one manual step is to hold the body of the syringe in order to insert the needle into the injection site, another step consists in pressing on the piston rod in order to administer the injection, the progression from one step to the other generally entailing moving the fingers with respect to the syringe.

There therefore remains a need for an injection assistance device and for an injection set which are made safe, that is to say which limit the risk of needlestick injury both to the patient and to the person administering the injection, preventing the reuse of the syringe after the injection completion, limiting the apprehension felt by the patient and making the injection easier. There also remains a need for such an injection assistance device and an injection set that allow the user to be certain of causing the needle to penetrate the injection site to a predetermined insertion depth in order to avoid unintentionally injecting the said product at an inadequate depth.

The present invention remedies these needs by proposing an injection assistance device for an injection device for injecting a product into an injection site, this injection device comprising at least one hollow body intended to receive a product that is to be injected, at least one hollow injection needle intended to penetrate the injection site, and at least one piston plunger housed in the said body, the said body and the said piston plunger being able to be moved in axial translation one with respect to the other, characterized in that the said assistance device comprises at least: a hollow sleeve provided with at least one bearing surface intended to come into contact with the surface of the said injection site, the said sleeve being intended to receive, at least in part, the said body and being arranged in such a way as to allow its axial mobility between at least a first position known as the initial position in which the said needle is not exposed over its insertion length, and a second position known as the insertion position in which the said needle is exposed by a predetermined insertion length L, a sleeve tube able to move with respect to the said sleeve and comprising at least one region for holding intended to be grasped in the user' s hand in order to urge the said sleeve tube axially towards the said injection site, the said sleeve tube also comprising coupling means intended to connect the said region for holding to the said piston plunger or to the said body at least in terms of axial translation, at least from the said initial position to the said insertion position so as to allow at least the said insertion with just one hand and in just one unidirectional axial movement, - said sleeve tube being formed of several coupling elements provided with shapes that collaborate with those of the said piston plunger, and able to connect the said sleeve tube to the said piston and to disengage by deformation, to release the said piston plunger, and at least partly forming the said coupling means .

As a preference, the said sleeve is arranged in such a way as to allow axial mobility of the said body at least between an injection position and a position known as the final protection position in which the said needle is covered by the said sleeve.

As a preference, the said sleeve tube is arranged in such a way as to allow axial mobility of the said sleeve at least between the said insertion position and a position known as the final protection position in which the said sleeve covers the said needle.

Advantageously, the said injection assistance device comprises at least one first elastically deformable element intended to bear between the said sleeve and the said body or the said sleeve tube so as to urge the said body or the said sleeve with respect to the said sleeve tube from the said injection position to the said protection position once the said axial force on the said sleeve tube has been released and without additional manual intervention on the part of the user.

As a preference, the device according to the invention comprises locking means arranged in such a way as to at least limit the translational movement of the said sleeve or of the said body with respect to the said sleeve tube once the said protection position has been reached .

Advantageously, the said sleeve tube is designed to prolong the movement of the said piston from the said insertion position to an end-of-injection position, the said coupling means being arranged in such a way as to remain coupled to the said piston at least in the distal direction during this axial movement.

As a preference, the injection assistance device according to the invention comprises retaining means arranged in such a way as to at least attempt to keep the said sleeve tube in the said initial position, and to release the said sleeve tube when the said axial force exerted on it reaches a predetermined value. Advantageously, the said retaining means comprise at least collaborating geometric shapes provided in the said sleeve tube and the said sleeve, the said collaborating geometric shapes being arranged in such a way as to be engaged in one another in the said initial position and to disengage and release the said sleeve tube when the said predetermined value of the force is reached.

In another embodiment of the invention, the said retaining means comprise at least frangible bridges connecting the said sleeve and the said sleeve tube and arranged in such a way as to yield and release the said sleeve tube when the said predetermined value of the force is reached.

In yet another embodiment of the invention, the said retaining means comprise at least one stop arranged between the said sleeve and the said sleeve tube or between the said sleeve tube and the said body and at least a second elastically deformable element intended respectively to urge the said sleeve, sleeve tube and body so as to keep them in abutment one with respect to the other. In one embodiment of the invention, the said sleeve tube defines a longitudinal skirt of which the distal part covers the proximal part of the said sleeve, at least in the insertion position.

Alternatively, the said sleeve defines a discontinuous longitudinal skirt in the proximal part of which the distal part of the said sleeve tube becomes inserted, at least in the insertion position, the solid parts of the said skirt then partially covering the said sleeve tube and the open parts allowing the said sleeve tube, and therefore the said injection set to be held.

In a preferred embodiment of the invention, the injection assistance device comprises control means arranged in such a way as to delimit the said insertion position of the said body.

As a preference, the said control means comprise at least one axial stop provided in the said sleeve and intended to have bearing against it at least one of the elements chosen from the group comprising the said body, the said sleeve tube, one of the said first, second, third, fourth elastically deformable elements.

As a preference, the said sleeve tube is arranged in such a way as to move distally until it comes into contact with the injection site in such a way as to delimit the said control means.

Advantageously, at least one of the said first and second elastically deformable elements is chosen from the group comprising a helical spring, a leaf spring, an element made of an elastically deformable material, a more or less sealed gas chamber.

As a preference, the injection assistance device according to the invention comprises guide means for guiding the said coupling elements and arranged in such a way as to allow them to disengage only after the said sleeve tube has covered a predetermined travel with respect to the said sleeve.

These coupling means may, for example, be in the form of a link by bonding or by friction, or an elastic link.

In another embodiment of the invention, the internal section of the said sleeve is greater in the distal part than in its proximal part so as to define the said guide means, at least in part, and allow the said coupling elements to be moved away once they have been disengaged from the said proximal part.

In yet another embodiment of the invention, the said sleeve tube comprises at least two portions collaborating with one another in order to define the said means of coupling with the said piston plunger, the said portions being equipped on their internal face with at least one tooth able to collaborate with the said sleeve so as to cause the said portions to separate when the said sleeve tube is in the said insertion position and allow relative mobility between the said piston plunger and the said body.

The present invention also solves the aforementioned needs by proposing an injection set for injecting a product into an injection site, this injection set comprising at least: an injection device as hereinabove comprising at least : a hollow body intended to receive a product that is to be injected, the said body being equipped with at least one region for holding and with a hollow injection needle intended, during a first phase known as the insertion phase, to penetrate an injection site and, during a second phase known as the injection phase, to channel the said product from the said body towards the said injection site, at least one piston plunger housed in a more or less sealed fashion in the said body and intended to be moved in the distal direction by movement means in the said injection phase during which it drives the said product through the said needle, characterized in that it comprises at least one injection assistance device as described hereinabove in the sleeve of which the said body is placed and the sleeve tube of which is linked at least in terms of axial translation to the said piston plunger or to the said body at least from the said initial position to the said insertion position.

As a preference, the said region for holding comprises a flange.

Advantageously, the injection set is in the form of a kit that can be assembled prior to use.

As a preference, the force to overcome the stiction of the said piston plunger in the said body is designed to be greater than the resultant of the force of compression of the said elastically deformable elements and the force to cause the said needle to penetrate the said injection site.

In one embodiment of the invention, the said piston is coupled to a piston rod arranged in such a way as to form the said sleeve tube.

Other advantages and alternative forms of the present invention will now be specified with the aid of the description which will follow and of the attached drawings in which:

Figures 1 to 4 are sectioned views of an injection set according to the invention in the following positions : initial, needle insertion, end of injection of the product and final protection,

- Figures 5 and 6 are sectioned views of a second alternative form of embodiment of an injection set according to the invention depicted in the following positions : initial and end-of- injection.

To make the invention easier to understand, the injection assistance device is described assembled with an injection device with which it forms an injection set .

Reference is made to Figures 1 to 4 which depict an injection set 100 according to the invention comprising an injection assistance device 1 for an injection device 3 comprising a hollow body 2 provided with a flange 10 and intended to receive a product 25 that is to be injected, a hollow injection needle 7 and at least one piston plunger 26 able to move in axial translation in a more or less sealed fashion inside the said body 2. The flange 10 can be part of the body 2 or fastened to it by any suitable means.

The injection assistance device 1 comprises a hollow sleeve 4 provided with a bearing surface 5 intended to be pressed against the injection site 27, a sleeve tube 6 able to move with respect to the said sleeve 4 and comprising a region for holding 8 intended to be grasped in the user' s hand, and a spring 9 arranged between the body 2 and the sleeve 4.

As is apparent from Figures 1 to 4, the sleeve 4 houses the body 2 in such a way that the body 2 is able to move in translation, on the one hand, between an initial position (Figure 1) in which the needle 7 is not exposed and an insertion position (Figures 2 and 3) in which the needle 7 is exposed and inserted into the injection site 27 and, on the other hand, between the insertion position and a final protection position in which the sleeve 4 entirely covers the needle 7 (see Figure 4) . As will be obvious from Figure 4, the sleeve 4 is urged into the final protection position by return means, in the form of the spring 9 in the example depicted.

As is clear from Figures 2 to 4, the sleeve 4 comprises a radial stop 12 situated on the internal wall of its distal part and a radial step 14 situated on the internal wall of its proximal part. The radial stop 12 may be in the form of a continuous or discontinuous annular bulge or alternatively in the form of at least one radial projection. Likewise, the radial step 14 may be in the form of a continuous or discontinuous annular bulge or alternatively in the form of at least one radial rim.

The proximal part 30 of the sleeve 4 has an internal section smaller than that of its distal part 31. The sleeve tube 6 defines a longitudinal skirt 47 in which it comprises a series of claws 32 linked with the region for holding 8 by joint 36. The region for holding 8 of the sleeve tube 6 is coupled to the distal end 37 of a piston rod 46 by the series of claws 32, each claw 32 or joint 36 being able to deform and bend between the claws 32 and the region for holding 8.

The distal part of the longitudinal skirt 47 of the sleeve tube 6 covers at least in the insertion position (see Figure 2) the proximal part of the said sleeve tube 4.

As will appear clearly from the following discussion, the sleeve tube 6 formed of several coupling elements, that is to say here the claws 32 provided with shapes that collaborate with those of the said piston rod 46, and able to connect the said sleeve tube 6 to the said piston plunger 26 and to disengage by deformation, to release the said piston rod 46 and therefore the piston plunger 26, and at least partly forming coupling means.

The way in which the injection set 100 works when administering a product 25 that is to be injected will now be explained with reference to Figures 1 to 4.

The injection assistance device 1 comes in an initial position depicted in Figure 1.

In this initial position, the body 2 comprises the product 25 that is to be injected and is closed off, at the opposite end to the needle 7, by the piston plunger 26 connected to the distal end 37 of the piston rod 46 coupled to the sleeve tube 6 by means of the claws 32 and joint 36. In this initial position, before the injection assistance device 1 is used, the sleeve 4 entirely covers the needle 7. It is possible to keep a gap between the sleeve 4 and the piston plunger 26 so as to prevent the product 25 from being pressurized in the body 2 while the injection set 100 is being stored and/or transported.

The sleeve 4 is retained in terms of translation with respect to the body 2 by means, on the one hand, of the spring 9 of which the distal end bears against the radial stop 12 and of which the proximal end bears against the distal face of the flange 10 which is blocked in translation towards the proximal direction by the radial step 14.

In this pre-use initial protection state of the injection device 3, the risks of needlestick injury are minimized, the needle 7 being entirely covered by the sleeve 4. The injection device 3 is thus completely safe. In this initial position, the claws 32 converge towards the distal end 37 of the piston rod 46 which they grip and hold fixed because of the thrust of the internal wall of the proximal part 30 of the sleeve 4 on the said claws 32.

The user then grasps hold of the injection assistance device 1 and places the bearing surface 5 of the sleeve 4 on the injection site 27 at right angles to the surface of the said injection site 27.

Whilst the injection assistance device 1 is positioned in the desired location for the injection, the user exerts an axial force in the distal direction on the region for holding 8 of the sleeve tube 6 in order to perform the phase of inserting the needle 7 into the injection site 27.

As the force required to overcome the stiction of the piston plunger 26 is greater than the compression force of the said spring 9 combined with the force to overcome the friction of the penetration of the needle

7 into the injection site 27, the body 2 and sleeve tube 6 assembly moves in the proximal direction under the action of the axial thrust, without the piston plunger 26 being moved within the body 2. This movement causes the spring 9 to be compressed.

Still under the action of the axial force exerted on the region for holding 8 of the sleeve tube 6, the needle 7 penetrates the injection site 27 until the distal end of body 2 contacts the injection site 27 and spring 9 is fully compressed, as shown on figure 2.

In this insertion position depicted in figure 2, the claws 32 still converge towards the distal end 37 of the piston rod 46 and they grip and hold the piston rod 46 fixed because of the thrust of the internal wall of the proximal part 30 of the sleeve 4 on the said claws 32.

Thus, the body 2 is in the insertion position, the needle 7 has penetrated the injection site 27 to a perfectly defined insertion depth L as can be seen in

Figure 2. By virtue of the contact between the distal end of body 2 and compression of spring 9, it is then no longer possible to cause the needle 7 to penetrate the injection site 27 any further. The insertion depth is thus perfectly controlled.

Alternatively, the depth L to which the needle 7 is inserted into the injection site 27 could be determined by a stop (not depicted) provided between the body 2 and the sleeve 4.

In order to progress to the injection phase, the user continues to exert axial force on the region for holding 8 of the sleeve tube 6 and therefore overcomes the stiction of the piston plunger 26 which, under the pressure of the sleeve tube 6, drives the product 25 that is to be injected through the needle 7 and then into the injection site 27.

In the end-of-injection position, as shown in Figure 3, the depth of insertion of the needle 7 has not varied, the piston plunger 26 is at the end of its travel in the body 2 and the spring 9 is still in the compressed state .

At the end of injection, as shown on figure 3, under the effect of the axial force exerted on the region for holding 8 of the sleeve tube 6, the claws 32 penetrate the distal part 31 of the sleeve 4 and, as they are no longer subjected to the thrust of the internal wall of the proximal part 30 of the sleeve 4, the joint 36 deform themselves and with the region for holding 8 and disengage by deformation from the proximal end 37 of the piston rod 46, thus releasing the axial force on the said piston rod 46 and causing the body 2 and therefore the needle 7, via the spring 9, to rise back up inside the sleeve 4, as depicted in Figure 4.

As clearly appears from these figures, the disengagement of the coupling means 46 is independent from the effort applied on the sleeve 6 but dependent on the location of an area allowing the deformation. Therefore, there is no need to apply a specific high force on the plunger rod 46 which could have cause a risk of inadvertent injection simultaneously or before to the insertion of the needle in the injection site 27.

In the final protection state depicted in Figure 4, the needle is not accessible and the injection assistance device 1 is perfectly safe. In addition, as coupling means have been disengaged, the injection assistance device cannot be used anymore.

The injection set 100 can then be discarded by the user.

Figures 5 and 6 depict an injection assistance device 1 according to the invention by which the means for controlling the insertion depth of the needle 7 are formed by a collar 38 internal to the sleeve tube 6 and surrounding the said body 2, the distal end 40 of the said collar 38 coming into abutment against the surface of the injection site 27 and the flange 10 coming into abutment against the proximal end 41 of the said collar

38.

In the assistance device 1 of Figures 5 and 6, the sleeve tube 6 comprises at least two arms 43 trapping the piston rod 46, each arm 43 being equipped on its internal face with a tooth 44 able to collaborate with a slope 45 formed at the proximal end of the sleeve 4 to cause the said arms 43 to separate and release the piston rod 46 under the action of an axial force exerted on the region for holding 8 once the needle 7 has reached the predetermined insertion depth L as depicted in Figure 6. The injection is then administered by exerting axial force on the piston rod 46, as depicted in Figure 6.

Such an embodiment makes it possible to block any translational movement of the piston rod 46 as long as the needle 7 has not reached the predetermined insertion depth L. Such an injection assistance device 1 therefore provides total control over the depth at which the product 25 is injected. It thus makes it possible to avoid the risks of intradermal injections when the injection is supposed to be subcutaneous, and vice versa.

In other forms of embodiment, not depicted, the helical springs may be replaced by leaf springs, pieces of elastomer, sealed gas chambers inside which the gas can be pressurized and expanded in succession, or any other equivalent means .

The injection set and the injection assistance device according to the invention are particularly simple to use and are perfectly safe. The entire injection operation can easily be performed by a single unidirectional axial movement, with just one hand.

Claims

1. Injection assistance device (1) for an injection device (3) for injecting a product (25) into an injection site (27), this injection device (3) comprising at least one hollow body (2) intended to receive a product (25) that is to be injected, at least one hollow injection needle (7) intended to penetrate the injection site (27), and at least one piston plunger (26) housed in the said body (2) , the said body
(2) and the said piston plunger (26) being able to be moved in axial translation one with respect to the other, characterized in that the said injection assistance device (1; 101) comprises at least: - a hollow sleeve (4) provided with at least one bearing surface (5) intended to come into contact with the surface of the said injection site (27), the said sleeve (4) being intended to receive, at least in part, the said body (2) and being arranged in such a way as to allow its axial mobility between at least a first position known as the initial position in which the said needle (7) is not exposed over its insertion length, and a second position known as the insertion position in which the said needle (7) is exposed by a predetermined insertion length L, a sleeve tube (6) able to move with respect to the said sleeve (4) and comprising at least one region for holding (8) intended to be grasped by the user's hand in order to urge the said sleeve tube (6) axially towards the said injection site (27), the said sleeve tube (6) also comprising coupling means (46) intended to connect the said region for holding (8) to the said piston plunger (26) or to the said body (2) at least in terms of axial translation, at least from the said initial position to the said insertion position so as to allow at least the said insertion with just one hand and in just one uni-directional axial movement, - said sleeve tube (6) being formed of several coupling elements (32, 36; 43) provided with shapes that collaborate with those of the said piston plunger (26) , and able to connect the said sleeve tube (6) to the said piston plunger (26) and to disengage by deformation, to release the said piston plunger (26) , and at least partly forming the said coupling means.
2. Injection assistance device (1) according to Claim 1, characterized in that the said sleeve (4) is arranged in such a way as to allow axial mobility of the said body (2) at least between an injection position and a position known as the final protection position in which the said needle (7) is covered by the said sleeve (4 ) .
3. Injection assistance device (1) according to Claim 1, characterized in that the said sleeve tube (6) is arranged in such a way as to allow the axial mobility of the said sleeve (4) at least between the said insertion position and a position known as the final protection position in which the said sleeve (4) covers the said needle (7).
4. Injection assistance device (1) according to Claim 2 or 3, characterized in that it comprises at least one first elastically deformable element (9) intended to bear between the said sleeve (4) and the said body (2) or the said sleeve tube (6) so as to urge the said body (2) or the said sleeve (4) with respect to the said sleeve tube (6) from the said injection position to the said protection position once the said axial force on the said sleeve tube (6) has been released and without additional manual intervention on the part of the user.
5. Injection assistance device (1) according to Claim 2 or 3, characterized in that it comprises locking means arranged in such a way as to at least limit the translational movement of the said sleeve (4) or of the said body (2) with respect to the said sleeve tube (6) once the said protection position has been reached.
6. Injection assistance device (1) according to Claim 1, characterized in that the said sleeve tube (6) is designed to prolong the movement of the said piston (26) from the said insertion position to an end-of- injection position, the said coupling means (46) being arranged in such a way as to remain coupled to the said piston plunger (26) at least in the distal direction during this axial movement.
7. Injection assistance device (1) according to Claim 1, characterized in that it comprises retaining means (4, 43) arranged in such a way as to at least attempt to keep the said sleeve tube (6) in the said initial position, and to release the said sleeve tube (6) when the said axial force exerted on it reaches a predetermined value.
8. Injection assistance device (1) according to Claim 7, characterized in that the said retaining means comprise at least collaborating geometric shapes (44, 45) provided in the said sleeve tube (6) and the said sleeve (4), the said collaborating geometric shapes (44, 45) being arranged in such a way as to be engaged in one another in the said initial position and to disengage and release the said sleeve tube (6) when the said predetermined value of the force is reached.
9. Injection assistance device (1) according to Claim 7, characterized in that the said retaining means comprise at least frangible bridges connecting the said sleeve (4) and the said sleeve tube (6) and arranged in such a way as to yield and release the said sleeve tube (6) when the said predetermined value of the force is reached.
10. Injection assistance device (1) according to Claim 7, characterized in that the said retaining means comprise at least one stop arranged between the said sleeve (4) and the said sleeve tube (6) or between the said sleeve tube (6) and the said body (2) and at least a second elastically deformable element (9) intended respectively to urge the said sleeve (4) , sleeve tube (6) and body (2) so as to keep them in abutment one with respect to the other.
11. Injection assistance device (1) according to Claim 1, characterized in that the said sleeve tube (6) defines a longitudinal skirt (47) of which the distal part covers the proximal part of the said sleeve (4), at least in the insertion position.
12. Injection assistance device (1) according to Claim 1, characterized in that the said sleeve (4) defines a discontinuous longitudinal skirt in the proximal part of which the distal part of the said sleeve tube (6) becomes inserted, at least in the insertion position, the solid parts of the said skirt then partially covering the said sleeve tube (6) and the open parts allowing the said sleeve tube (6) to be held.
13. Injection assistance device (1) according to Claim 1, characterized in that it comprises control means arranged in such a way as to delimit the said insertion position of the said body (2) .
14. Injection assistance device (1) according to Claim 13, characterized in that the said control means comprise at least one axial stop provided in the said sleeve (4) and intended to have bearing against it at least one of the elements chosen from the group comprising the said body (2), the said sleeve tube (6), one of the said first and second elastically deformable elements (9) .
15. Injection assistance device (1) according to Claim 13, characterized in that the said sleeve tube (6) is arranged in such a way as to move distally until it comes into contact with the injection site (27) in such a way as to delimit the said control means.
16. Injection assistance device (1) according to one of the preceding claims, characterized in that at least one of the said first and second elastically deformable elements (9) is chosen from the group comprising a helical spring, a leaf spring, an element made of an elastically deformable material, a more or less sealed gas chamber.
17. Injection assistance device (1) according to Claim 1, characterized in that it comprises guide means (30, 31) for guiding the said coupling elements (32) and arranged in such a way as to allow them to disengage only after the said sleeve tube (6) has covered a predetermined travel with respect to the said sleeve (4 ) .
18. Injection assistance device (1) according to Claim 17, characterized in that the internal section of the said sleeve (4) is greater in the distal part (31) than in its proximal part (30) so as to define the said guide means, at least in part, and allow the said coupling elements (32) to be moved away once they have been disengaged from the said proximal part.
19. Injection assistance device (1) according to Claim 12, characterized in that the said sleeve tube (6) comprises at least two portions (43) collaborating with one another in order to define the said means of coupling with the said piston plunger (26) , the said portions (43) being equipped on their internal face with at least one tooth (44) able to collaborate with the said sleeve (4) so as to cause the said portions
(43) to separate when the said sleeve tube (6) is in the said insertion position and allow relative mobility between the said piston plunger (26) and the said body (2).
20. Injection set (100) for injecting a product (25) into an injection site (27), the said injection set (100) comprising at least: an injection device (3) comprising at least: a hollow body (2) intended to receive a product (25) that is to be injected, the said body (2) being equipped with at least one region for holding (10) and with a hollow injection needle (7) intended, during a first phase known as the insertion phase, to penetrate an injection site (27) and, during a second phase known as the injection phase, to channel the said product (25) from the said body (2) towards the said injection site (27), at least one piston plunger (26) housed in a more or less sealed fashion in the said body (2) and intended to be moved in the distal direction by movement means in the said injection phase during which it drives the said product (25). through the said needle (7), characterized in that it comprises at least one injection assistance device (1) according at least to Claim 1, in the sleeve (4) of which the said body (2) is placed and the sleeve tube (6) of which is linked at least in terms of axial translation to the said piston plunger (26) or to the said body (2) at least from the said initial position to the said insertion position.
21. Injection set (100) according to Claim 20, characterized in that the said region for holding comprises a flange (10) .
22. Injection set (100) according to Claim 20, characterized in that it is in the form of a kit that can be assembled prior to use.
23. Injection set (100) according to Claims 10 and 20, characterized in that the force to overcome the stiction of the said piston plunger (26) in the said body (2) is designed to be greater than the resultant of the force of compression of the said elastically deformable elements (9) and the force to cause the said needle (7) to penetrate the said injection site (27).
24. Injection set (100) according to Claim 20, characterized in that the said piston (26) is coupled to a piston rod (46) arranged in such a way as to form the said sleeve tube (6) .
PCT/IB2006/001333 2005-04-20 2006-04-14 Injection set and injection assistance device WO2006111859A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
FR05.03964 2005-04-20
FR0503964A FR2884722A1 (en) 2005-04-20 2005-04-20 Injection assembly and support device
PCT/IB2006/001333 WO2006111859A1 (en) 2005-04-20 2006-04-14 Injection set and injection assistance device

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IB2006/001333 WO2006111859A1 (en) 2005-04-20 2006-04-14 Injection set and injection assistance device

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WO2006111859A1 true true WO2006111859A1 (en) 2006-10-26

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PCT/IB2006/001333 WO2006111859A1 (en) 2005-04-20 2006-04-14 Injection set and injection assistance device
PCT/IB2006/001351 WO2006111860A1 (en) 2005-04-20 2006-04-18 Injection set and injection assistance device

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FR (1) FR2884722A1 (en)
WO (3) WO2006111861A3 (en)

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WO2008107381A1 (en) * 2007-03-02 2008-09-12 Novo Nordisk A/S Medication delivery device with pre-set bolus pump
FR2934165A1 (en) * 2008-07-28 2010-01-29 Marc Brunel Injection device Secure single use
JP2011524779A (en) * 2008-06-19 2011-09-08 ベティ,ラヴィンダー Apparatus for detecting the epidural space while preventing dural puncture by technique by resistance difference
CN103025374A (en) * 2010-07-02 2013-04-03 赛诺菲-安万特德国有限公司 Safety device for a pre-filled syringe, injection device and injection kit
US9216256B2 (en) 2009-10-16 2015-12-22 Janssen Biotech, Inc. Palm activated drug delivery device
US9233213B2 (en) 2009-10-16 2016-01-12 Janssen Biotech, Inc. Palm activated drug delivery device
CN105764547A (en) * 2013-11-25 2016-07-13 阿普塔尔法国简易股份公司 Auto-injector

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JP5905002B2 (en) * 2010-07-02 2016-04-20 サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング Safety device for pre-filled syringes and injection devices
EP2588167B1 (en) 2010-07-02 2018-02-21 Sanofi-Aventis Deutschland GmbH Safety device for a pre-filled syringe and injection device
CN103415314B (en) * 2011-01-04 2015-11-25 赛诺菲-安万特德国有限公司 Safety device for an injection device and pre-filled syringes
EP2572741A1 (en) * 2011-09-23 2013-03-27 Sanofi-Aventis Deutschland GmbH Medicament delivery device and actuation mechanism for a drug delivery device
WO2013146050A1 (en) * 2012-03-30 2013-10-03 テルモ株式会社 Liquid administration device
US9707343B2 (en) 2012-05-25 2017-07-18 Aptar France Sas Autoinjector comprising a time delay device having a planetary gear set for delaying the retraction of the needle
FR2990862B1 (en) * 2012-05-25 2015-05-15 Valois Sas autoinjector
CN104394910B (en) * 2012-05-25 2016-12-21 阿普塔尔法国简易股份公司 Automatic injector
US9707357B2 (en) 2012-05-25 2017-07-18 Aptar France Sas Autoinjector
US9717851B2 (en) 2012-05-25 2017-08-01 Aptar France Sas Autoinjector
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WO2008034743A1 (en) * 2006-09-19 2008-03-27 Cambridge Biostability Limited An injector
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CN103025374A (en) * 2010-07-02 2013-04-03 赛诺菲-安万特德国有限公司 Safety device for a pre-filled syringe, injection device and injection kit
CN105764547A (en) * 2013-11-25 2016-07-13 阿普塔尔法国简易股份公司 Auto-injector

Also Published As

Publication number Publication date Type
FR2884722A1 (en) 2006-10-27 application
WO2006111860A1 (en) 2006-10-26 application
WO2006111861A2 (en) 2006-10-26 application
WO2006111861A3 (en) 2007-02-22 application

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