This application is a National Stage of International Application No. PCT/FR2015/051827 filed Jul. 2, 2015, claiming priority based on French Patent Application No. 1456432, filed Jul. 4, 2014, the contents of all of which are incorporated herein by reference in their entirety.
The present invention relates to an autoinjector.
Autoinjectors are well known in the prior art. The purpose of such devices is mainly to inject the contents of a syringe automatically into a patient's body. Various systems exist for making the penetration of the needle into the body of the patient and the injection of the fluid contained in the syringe automatic. Autoinjectors are relatively complex devices that must satisfy a certain number of constraint requirements in order to be reliable. The robustness of the device, its handling, and its ease of use for the user are also important elements. In addition, since most autoinjectors are for single use, the cost of manufacture and of assembly is also a factor that needs to be taken into account.
Numerous autoinjectors exist on the market, but they all present a certain number of drawbacks.
Thus, for autoinjectors that use the same spring both for initial pricking then for injection proper, the spring must be sufficiently strong to guarantee the injection stage in full. This is particularly true given that a relatively large force is generally required at the beginning of the injection stage, in order to start the movement of the piston of the syringe. As a result, the spring delivers its maximum power during pricking, which may make the pricking stage painful. Furthermore, with such a spring that is very powerful during pricking, there exists a significant risk of breaking the collar of the syringe, in particular when it is a glass syringe.
In addition, it may be desirable to have a visual and/or audible indication to inform the user that injection has terminated.
An object of the present invention is to provide an autoinjector that does not have the above-mentioned drawbacks, and that makes it possible to satisfy the various major requirements and constraints for safe and reliable use of the autoinjector.
Another object of the present invention is to provide an autoinjector that is reliable and safe in use, that makes it possible to guarantee that all of the fluid is dispensed to the desired location, that informs the user in reliable manner that injection has ended, and that is simple and inexpensive to manufacture and to assemble.
The present invention thus provides an autoinjector comprising a body, and a reservoir containing fluid and including a piston and a needle, such as a pre-filled syringe, said autoinjector further comprising a piston rod that is adapted to co-operate with the piston of said reservoir, said piston rod being movable between a rest position and an injection position in which said piston rod has moved the piston of the reservoir so as to inject the fluid through the needle, an actuator spring being provided so as to urge said piston rod towards its injection position, the autoinjector further comprising a force-adjustment system that is adapted to exert at least one force F2 on said piston rod, said force F2 adding to the force exerted by said actuator spring on said piston rod at the beginning of injection, so as to amplify the force exerted on said piston by said piston rod at the beginning of injection, said force-adjustment system comprising two pivot members that co-operate with said piston rod, said pivot members being connected together by two resilient elements, said body including a sleeve, said pivot members being pivotally mounted on said sleeve to pivot about stationary pins, said autoinjector including a visual and/or audible indicator that is adapted to inform the user that injection has ended, said indicator being formed by and/or fastened to said sleeve and including an indication portion that is movable and/or deformable relative to said body so as to co-operate with at least one viewing window of said autoinjector after the end of injection.
Advantageously, said resilient elements are fastened to said pivot members via parallel movable pins, such as rods having two side edges, that are formed on said pivot members.
Advantageously, when the piston rod moves towards its injection position, said movable pins are arranged behind said stationary pins in the travel direction of said piston rod, said loaded resilient elements, at the beginning of travel of the piston rod towards its injection position, causing said pivot members to pivot in such a manner as to relax said resilient elements, thereby creating an amplification force F2 at the beginning of injection.
Advantageously, each pivot member includes a plurality of projections that are adapted to co-operate with a plurality of radial projections of the piston rod.
Advantageously, during pricking, the piston rod co-operates with the piston of the reservoir so as to move said reservoir relative to the body.
Advantageously, prior to injection, said piston rod is initially moved by said actuator spring between said rest position and a pricking position in which said piston rod has moved said reservoir relative to said body so as to perform pricking.
Advantageously, during pricking, the piston rod co-operates with the piston of the reservoir so as to move said reservoir relative to the body.
Advantageously, when the piston rod moves from its rest position towards its pricking position, said movable pins are arranged in front of said stationary pins in the travel direction of said piston rod, said piston rod, at the end of travel towards its pricking position, causing said pivot members to pivot so as to load said resilient elements, thereby creating a braking force F1 at the end of pricking, said force F1 being opposed, at the end of pricking, to the force exerted by said actuator spring on said piston rod, so as to decrease the force exerted on said reservoir by said piston rod at the end of pricking.
Advantageously, said autoinjector is actuated by an axial button.
Advantageously, said at least one viewing window is formed in said axial button.
Advantageously, said axial button includes a single viewing window that is arranged in a sloping axial end wall of said axial button.
In a variant, said axial button includes a plurality of viewing windows, distributed around the outer axial end edge of said axial button.
In another advantageous embodiment, said at least one viewing window is formed in said body.
Advantageously, said indicator is formed by said sleeve, including a single-piece axial projection that forms said indication portion of the indicator.
In a variant, said indicator is formed by a pivotable indicator element that is pivotally mounted on said sleeve, an end portion of said pivotable indicator element forming said indication portion of the indicator.
Advantageously, said pivotable indicator element is pivoted by said pivot members at the end of injection.
Advantageously, said sleeve includes at least one axial tab that is radially deformable and that co-operates with said body, said axial tab being prevented from deforming by said piston rod prior to and during movement of said piston rod, thus blocking any axial movement of said sleeve relative to said body, said piston rod releasing said blocking at the end of injection, such that said axial tab deforms radially inwards, enabling said sleeve to move axially relative to said body so as to provide a visual and/or audible indication.
These characteristics and advantages and others of the present invention appear more clearly from the following detailed description, given by way of non-limiting examples, and with reference to the accompanying drawings, and in which:
The autoinjector is described below with reference to several advantageous embodiments. It should nevertheless be observed that autoinjectors, which are complex appliances, comprise a plurality of modules for performing a plurality of functions. The various modules may be used separately and independently of one another, without necessarily being combined with the other modules, and in particular they could be used in autoinjectors of shape that is different from the shape shown in the drawings. Furthermore, it should be observed that the drawings are diagrammatic views, which do not necessarily represent the exact shape of the components of an autoinjector, and they are not necessarily to scale, in particular for purposes of clarity. In addition, the drawings do not necessarily represent all of the component elements of an autoinjector, but only the elements necessary for operation of the present invention. Thus, various additional and/or complementary elements and modules could be associated with the autoinjector shown in the figures.
With reference to
In the order of the numerical references, the autoinjector comprises a lower body 1, an upper body 2 containing a sleeve 3, an axial actuator button 4, a piston rod 5, an actuator spring 6, and two pivot members 7 that are interconnected by means of two resilient elements 8, which are preferably in the form of springs.
It should be observed that the lower and upper bodies could be replaced by a single body. Alternatively, a body constituted by more than two body portions may also be envisaged.
The sleeve 3 may be clipped in the upper body 2 by means of a clip 33, which can be seen in particular in
A reservoir S is inserted into said autoinjector, in particular into its lower body 1. The reservoir S contains fluid and includes a piston and a needle (not shown in this embodiment). The piston is adapted to move in said reservoir S so as to inject the fluid through said needle.
The present description is made with reference to a syringe S that may be of any type. More generally, it is understood that the term “syringe” in the present description encompasses any type of reservoir associated with a needle. Preferably, the reservoir S is a pre-filled syringe.
The lower body 1, at its leading end (in the travel direction of the syringe S), includes an opening through which the needle passes during the pricking stage.
The lower body 1 contains an actuator sleeve 100 having an axial end surface 105 that is in contact with the part of the user's body where injection should take place. After actuation, the actuator sleeve 100 covers the needle of the syringe S so as to avoid any risk of pricking with said needle. The actuator sleeve 100 is adapted to slide relative to said lower body 1 between an initial rest position in which it projects axially out from said lower body 1 prior to actuation, an actuated position in which it moves axially towards the inside of said lower body 1, and a final safety position in which it once again projects out from said lower body 1, so as to cover the needle of the syringe S after injection. It should be observed that the final safety position may be identical to the initial rest position, or, in a variant, the two positions may be different, e.g. with the actuator sleeve 100 axially extending out from said lower body 1 in said final safety position further than in said initial rest position. The actuator sleeve 100 is advantageously urged axially towards the outside of said lower body 1 by a spring 110.
The lower body 1 may also contain an inner body 120 that is able to receive a reservoir support element 130 into which said syringe S is inserted.
The upper body 2 is fastened to the lower body 1 and it may receive a central sleeve 3 that is adapted to house the piston rod 5 and the spring 6.
The axial actuator button 4 may be mounted to slide axially relative to the upper body 2, and in contact with the piston rod 5. Thus, by pressing on the axial button 4 so as to drive it axially into the upper body 2, the piston rod 5 is moved axially, thereby making it possible to actuate the device as described below. In a variant, the axial button could be replaced by a lateral button.
The piston rod 5 includes a trailing portion 54 and a leading end 55 in the travel direction of the piston rod 5 in the upper body 2.
In this embodiment, the trailing portion 54 defines a tubular portion that receives the spring 6 and a portion of the axial button 4.
The purpose of the leading end 55 is to contact the piston of the syringe S, so as to move said piston and thus inject the fluid contained in the syringe S through the needle.
The piston rod 5 may also include a plurality of radial projections 52, 53: a first radial projection 52, that is close to the leading end 55, and that defines a shoulder-forming leading surface 51; and a second radial projection 53, that is axially offset from said first radial projection 52 towards the trailing end 54, and that defines both a leading surface and a trailing surface. Naturally, this is only an embodiment example, and a person skilled in the art is capable of making the radial projections and shoulders in a way that is different from the way shown in the drawings. In particular, said radial projections 52, 53 are not necessarily in the leading portion of the piston rod 5, as shown in the drawings, but they could be made on another portion of the piston rod 5. Indentations could alternatively replace the projections.
The actuator spring 6 may bear firstly against the sleeve 3, and secondly against the piston rod, e.g. against a fourth shoulder 58 that is axially offset from said third shoulder 53 towards the trailing portion 54. In the embodiment shown, the fourth shoulder 58 forms a base of the above-mentioned tubular portion.
The pivot members 7 are advantageously assembled in pivotable manner on the sleeve 3, and they are advantageously identical. Preferably, they are arranged on either side of the piston rod 5. They are not movable axially relative to said lower body 1, but only in pivoting about their pivot pins 79, which are parallel. In a variant, they could be assembled in some other way, in particular on the lower body 1 or on the upper body 2.
Each pivot member 7 may include a plurality of projections 71, 72, 73: a first projection 71 that is adapted to co-operate with the leading surface (in the axial travel direction of the piston rod during actuation) of the first radial projection 52 of the piston rod 5; a second projection 72 that is adapted to co-operate with the leading surface of the second radial projection 53; and a third projection 73 that is adapted to co-operate with the trailing surface of the second radial projection 53. Naturally, other embodiments can also be envisaged, e.g. with a different number of projections. Indentations could alternatively replace the projections.
The resilient elements 8 connect the two pivot members 7 together. The principle consists in combining two stationary pivot pins, in particular the pivot pins 79 of the two pivot members 7, with two movable pins, in particular the fastener points 78 of the pivot members 7 on which the resilient elements 8 are fastened.
Thus, as can be seen in
Thus, when the movable pins 78 are axially offset relative to the stationary pivot pins 79, they exert a force by means of the resilient elements 8.
When said movable pins 78 are arranged in front of said stationary pins 79 in the travel direction of the piston rod 5, the force opposes the pivoting imparted to said pivot members 7 by said piston rod 5. The pivoting of the pivot members 7 is thus braked by said resilient elements 8.
In contrast, when said movable pins 78 are arranged behind said stationary pins 79 in the travel direction of the piston rod 5, the force acts in the same direction as the pivoting imparted to said pivot members 7 by said piston rod 5. The pivoting of the pivot members 7 is thus amplified by said resilient elements 8.
When the stationary and movable pins 79, 78 are in alignment, there is a neutral point in which said resilient elements 8 do not influence the pivoting of the pivot members 7. It is in this position that the system toggles from a “braking” or “damping” state into an “amplification” state.
Such a force-adjustment system that is adapted to exert a force F1 and/or a force F2 on said piston rod 5. At the end of pricking the force F1 opposes the force exerted by the actuator spring 6 on the piston rod 5, so as to decrease the force exerted on said reservoir S by said piston rod 5 at the end of pricking. In contrast, at the beginning of injection, the force F2 is added to the force exerted by the actuator spring 6 on the piston rod 5, so as to amplify the force that is exerted on said piston P by said piston rod 5 at the beginning of injection. The force-adjustment system may exert only the force F1, only the force F2, or both of the forces F1 and F2.
In
The locking system 200 may include at least one locking element that is movable and/or deformable between a locked position in which it prevents at least one pivot member 7 from pivoting, and an unlocked position in which said at least one pivot member 7 can pivot. Said locking element 201 is urged resiliently towards its locked position by a drive member 210, such as a resilient blade. Advantageously, said locking element 201 is mounted to pivot on said sleeve 3 of said body, about a pivot pin 205. In the embodiment shown, said locking element 201 comprises both a blocking portion 202 that co-operates directly with a pivot member 7, and also a control portion 203 that co-operates with an unlocking element 101 that is secured to the actuator sleeve 100. Preferably, said unlocking element 101 is formed by an axial projection of said actuator sleeve 100. The unlocking element could be made in some other way.
When the user wishes to use the autoinjector, the user takes hold of the device, e.g. at the upper body 2, and presses the actuator sleeve 100 against the part of the body where the injection is to be performed. The actuator sleeve 100 thus moves axially towards the inside of the lower body 1. When the stroke of said actuator sleeve 100 towards the inside of the lower body 1 is sufficient to enable co-operation between the locking element 201 and the unlocking element 101, the unlocking element 101 causes the locking element 201 of the locking system to pivot about its pin 205, which releases the pivot members 7. When the user relaxes the pressure on the actuator sleeve 100 without actuating the autoinjector via the actuator button 4, the resilient blade 210 returns the locking element 201 into its locked position. In particular, this enables the user to select the injection site by testing a plurality of locations without actuating the actuator button 4. When, after unlocking the pivot members 7 by pressing on the actuator sleeve 100, the user presses on the axial actuator button 4, thereby moving the piston rod 5 axially a little and causing the pivot members 7 to pivot and the autoinjector to be actuated.
Advantageously, said unlocking element 101 co-operates with said locking system 200 at the end of stroke of said actuator sleeve 100, between its initial rest position and its actuated position, in particular when said actuator sleeve 100 has performed at least 90% of said stroke. This makes it possible to stop actuating the autoinjector only when the user is certain that the fluid will be expelled at the desired injection depth, and thus avoids the risk of premature actuation at a depth that is too shallow.
The pivoting of the pivot members 7 generated by the actuation force causes the first projection 71 and the first shoulder 51 to disengage from each other. This thus releases the piston rod 5 that is then moved axially under the effect of the actuator spring 6. This causes the syringe S to move in the lower body 1 and thus causing pricking.
When the second projection 72 of the pivot members reaches the leading surface of the second radial projection 53 of the piston rod 5, the pricking stage is not completely terminated. This can be seen in
As the pivot members 7 pivot during the pricking stage, the resilient elements 8 become increasingly tensioned. Simultaneously, the movable pins 78 of the pivot members 7 move progressively towards the stationary pins 79. The device is advantageously adjusted so as to generate maximum torque at (or just prior to) the end of the pricking stage. The neutral point in which the movable and stationary pins are in alignment may thus be reached at (or just prior to) the end of the pricking stage.
When the pivot members 7 and the resilient elements 8 are in the neutral position, shown in
When the needle reaches its pricking position with the needle fully inserted, the injection stage is triggered, and this is shown in
At the beginning of the injection stage, the third projection 73 of each pivot member 7 thus comes into contact with the trailing surface of the second radial projection 53. As at the end of the pricking stage, the torque exerted by the system is at a maximum immediately after the neutral position, and the tensioned resilient elements 8 thus urge the pivot members 7 strongly in pivoting. This causes the force of the actuator spring 6 to be amplified at the beginning of the injection stage. This amplification increases the force exerted by the piston rod 5 on the piston, and thus makes it possible to guarantee that the piston starts to move from its rest position, without having to increase the force of the actuator spring 6. Specifically, the maximum resistance during the injection stage is created when starting movement of the piston. Once injection has begun, the friction of the piston in the syringe S, the viscosity of the fluid to be injected, and the resistance of the narrow passage of the needle are smaller and thus no longer require the same force from the actuator spring 6.
As can be seen in
In the rest position shown in
In this embodiment, the force-adjustment system thus exerts only the amplification force F2 at the beginning of injection, and does not intervene during pricking.
In the invention, the autoinjector includes a visual and/or audible indicator 300 for informing the user that injection has ended. The indicator includes an indication portion that comes to co-operate with at least one viewing window at the end of injection, so as to provide a visual indication. Advantageously, the indicator also provides an audible indication in addition to the above-mentioned visual indication. The invention that is described in greater detail below is equally applicable to the auto-pricking embodiment described with reference to
The sleeve 3 includes at least one, and preferably two, axial tabs 31, each of which is radially deformable and provided with a head 32. The head 32 co-operates with a portion of the upper body 2, specifically an inner sleeve 25 of said upper body 2. Each axial tab 31 is deformable radially inwards, and prior to and during actuation is prevented from deforming by the piston rod 5, in particular a hollow sleeve 550 of said piston rod 5 that receives the actuator spring 6. During injection, the piston rod 5 moves axially relative to said sleeve 3, and, at the end of injection, the piston rod no longer blocks the axial tabs 31. The axial tabs may then deform radially inwards, as can be seen in
During the axial movement of the sleeve 3 relative to the upper body 2, an audible indication is advantageously provided by a shoulder 34 that is formed on the sleeve 3, as can be seen in
In the embodiments in
In the embodiment in
Naturally, other variant embodiments are also possible.
Typically, it is possible to obtain damping and/or amplification forces F1, F2 of about 30 newtons (N). Naturally, other damping and braking values could be obtained by selecting in appropriate manner the resilient elements 8, and by dimensioning in appropriate manner the pivot members 7.
The present invention applies to devices used in particular for treatment of auto-immune diseases, e.g. of the rheumatoid arthritis, multiple scleroses, Crohn's disease type, for treatment of cancer, for antiviral treatments, e.g. of the hepatitis type, for treatment of diabetes, for treatment of anemia, or for treatment of allergy attacks, e.g. in the event of anaphylactic shock.
Although the present invention is described above with reference to several advantageous embodiments, naturally various modifications are possible for the person skilled in the art, without going beyond the ambit of the present invention, as defined by the accompanying claims.
Number | Date | Country | Kind |
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14 56432 | Jul 2014 | FR | national |
Filing Document | Filing Date | Country | Kind |
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PCT/FR2015/051827 | 7/2/2015 | WO | 00 |
Publishing Document | Publishing Date | Country | Kind |
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WO2016/001592 | 1/7/2016 | WO | A |
Number | Name | Date | Kind |
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20050277886 | Hommann et al. | Dec 2005 | A1 |
20080195056 | Bishop | Aug 2008 | A1 |
Number | Date | Country |
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2 705 862 | Mar 2014 | EP |
2009010591 | Jan 2009 | WO |
2011043714 | Apr 2011 | WO |
2011101382 | Aug 2011 | WO |
WO-2012045838 | Apr 2012 | WO |
2015001280 | Jan 2015 | WO |
Entry |
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International Preliminary Report on Patentability dated Jan. 19, 2017, issued by the International Bureau and corresponding application No. PCT/FR2015/051827. |
International Search Report of PCT/FR2015/051827, dated Oct. 26, 2015. [PCT/ISA/210]. |
Number | Date | Country | |
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20180185581 A1 | Jul 2018 | US |