Source: https://patents.google.com/patent/EP2900299A1/en
Timestamp: 2020-08-08 10:45:28
Document Index: 415653476

Matched Legal Cases: ['art 1501', 'art 1501', 'art 1501', 'arts 1502', 'art 1501', 'arts 1502', 'art 1501', 'arts 1502']

EP2900299A1 - Autoinjector - Google Patents
EP2900299A1
EP2900299A1 EP13731360.7A EP13731360A EP2900299A1 EP 2900299 A1 EP2900299 A1 EP 2900299A1 EP 13731360 A EP13731360 A EP 13731360A EP 2900299 A1 EP2900299 A1 EP 2900299A1
EP13731360.7A
EP2900299B1 (en
2012-09-27 Priority to FR1259123A priority Critical patent/FR2995790B1/en
2013-05-24 Priority to PCT/FR2013/051144 priority patent/WO2014049214A1/en
2015-08-05 Publication of EP2900299A1 publication Critical patent/EP2900299A1/en
2020-07-08 Application granted granted Critical
2020-07-08 Publication of EP2900299B1 publication Critical patent/EP2900299B1/en
229940090047 Auto-Injector Drugs 0.000 title claims abstract description 108
238000002347 injection Methods 0.000 claims abstract description 181
239000007924 injection Substances 0.000 claims abstract description 181
229940071643 Prefilled Syringe Drugs 0.000 claims abstract description 7
238000006073 displacement Methods 0.000 claims description 34
Autoinjector having a pre-filled syringe, a piston rod (1005), an injection spring (1008), a movable element (1004; 1006), an acoustic and/or tactile indicating device (1500) having a key (1121), said key having a shaft part (1120), which extends inside the piston rod (1005), and a head part (1122), said movable element having at least one deformable tab (1510; 1520), said piston rod (1005) exerting traction on said head part (1122) via said shaft part (1121) of said key (1120) at the end of injection, thereby permitting a radial deformation of said at least one deformable tab and an axial movement of said movable element under the effect of said injection spring (1008), said movement generating an acoustic and/or tactile indication for the user.
The present invention therefore relates to an autoinjector comprising an outer shell, a reservoir containing fluid and comprising a piston and a needle, such as a pre-filled syringe, said autoinjector comprising a piston rod adapted to cooperate with the piston of said reservoir, said piston rod being movable between a loaded position and an injection position in which said piston rod has moved the piston of the reservoir to inject the fluid through the needle, an injection spring being provided for urging said piston rod towards its injection position, the autoinjector comprising a movable element, at least partially containing said piston rod and said injection spring, said piston rod being movable with respect to said movable element during the phase injection, said autoinjector comprising an audible indication device and / or tactile comprising a key, said key having a rod portion which extends inside the piston rod, and a head portion, said movable element comprising at least one deformable tab, said head portion of said key cooperating before injection with said at least one deformable tab to prevent any radial deformation thereof, blocking said movable member relative to said outer shell, said piston rod, at the end of injection, exerting via said shaft portion said key being pulled on said head portion of said key, causing said key to move relative to said at least one deformable tab, thus allowing radial deformation of said at least one deformable tab and axial displacement of said movable member under the effect of said injection spring, said displacement generating an audible and / or tactile indication for the user.
Advantageously, said movable element is a control sleeve comprising one or more deformable tabs.
Advantageously, said movable element is a support pad having one or more deformable tabs.
Advantageously, the sound and / or tactile indication is generated by the contact between said movable element and said outer shell.
Advantageously, said outer shell comprises at least one window providing a visual indication simultaneously with the sound and / or tactile indication.
Advantageously, said at least one window is disposed on the end edge of said outer shell, said at least one deformable tab being visible in said at least one window after the end of the injection.
The present invention also relates to an autoinjector comprising an outer shell, a reservoir containing fluid and comprising a piston and a needle, such as a pre-filled syringe, said autoinjector comprising a piston rod adapted to cooperate with the piston said tank, said piston rod being movable between a loaded position and an injection position in which said piston rod has moved the piston of the reservoir to inject the fluid product through the needle, an injection spring being provided for urging said piston rod towards its injection position, the autoinjector comprising a control sleeve, containing said rod of piston and said injection spring, said piston rod being displaceable with respect to said control sleeve during the injection phase, characterized in that said autoinjector comprises an audible and / or tactile indication device comprising a central piece connected to said piston rod by a wire, said central piece being connected to at least one lateral piece by a foldable and / or breakable connection, said piston rod being, at the end of the injection, adapted to exert via said wire a traction on said central piece, causing the deformation and / or breakage of said at least one foldable and / or breakable connection and thus the deformation and / or displacement of said at least one pi laterally, thus permitting axial displacement of said control sleeve under the effect of said injection spring, said displacement generating a sound and / or tactile indication for the user.
Advantageously, said central piece comprises two lateral pieces each connected to said central piece by a breakable connection.
Advantageously, said central piece, before injection, is disposed around said piston rod, outside said control sleeve.
Advantageously, the sound and / or tactile indication is generated by the contact between said control sleeve and said at least one lateral piece and / or by the contact between said at least one lateral piece and said outer shell.
Advantageously, said central piece is made in the form of a cylindrical sleeve.
These and other features and advantages of the present invention will appear more clearly in the following detailed description, with reference to the accompanying drawings, given by way of non-limiting examples, and in which: FIG. 1 is a schematic perspective exploded view of the components of an autoinjector, according to a first advantageous embodiment,
FIG. 4 is a detailed view showing the actuator sleeve in the position of FIG. 3a,
FIGS. 5 and 6 are diagrammatic cross-sectional views along two different section planes showing the actuator sleeve in the position of FIG. 4,
FIG. 17 is a view similar to that of FIG. 13, at the end of actuation, when the user removes the autoinjector from the injection site, FIG. 18 is a view similar to that of FIG. 17, when the actuator sleeve is locked,
FIG. 23 is a diagrammatic perspective view partially cut away of the injection lock of FIG. 19, in the locked position,
FIG. 24 is a diagrammatic cross-sectional view of the injection lock of FIG. 19, in the locked position,
FIG. 32 is an exploded schematic perspective view of an advantageous syringe displacement mechanism, FIGS. 33 to 35 are schematic partially cut-away perspective views of the displacement mechanism of FIG. 32, before actuation, in three different orientations,
FIG. 44 is a schematic view of the movement mechanism of FIG. 32 at the beginning of retraction initiated by the actuator sleeve,
FIGS. 45 and 46 are views similar to FIGS. 43 and 44, at the end of the injection,
FIG. 51 is a view similar to that of FIG. 50a, illustrating an alternative embodiment, FIG. 52 is an enlarged detail view in cut-away perspective, showing a variant of an actuator sleeve with breakable bridges,
FIGS. 53a and 53b illustrate schematic views of the autoinjector before injection,
Figures 57a, 57b and 57c show the autoinjector before injection,
FIGS. 58a, 58b and 58c show the autoinjector after injection but before actuation of the audible and / or tactile indication device,
FIGS. 59a, 59b and 59c show the autoinjector after injection and after actuation of the audible and / or tactile indication device,
FIG. 60 is a schematic exploded perspective view illustrating an alternative embodiment of the audible and / or tactile indication device,
FIGS. 67a and 67b are schematic views of the key of the audible and / or tactile indication device of FIG. 65, FIGS. 68a, 68b and 68c are views similar to FIGS. 64a, 64b and 64c, illustrating the audible and / or tactile indication device of FIG. 65,
The autoinjector will be described hereinafter with reference to various variants of two advantageous embodiments thereof. A first embodiment is shown in Figures 1 to 46 and a second embodiment is shown in Figures 47 to 74c. It should be noted, however, that these autoinjectors, which are complex devices, include several modules to perform several functions. These various modules can be used separately and independently of each other, without necessarily being combined with other modules, and could in particular be used in autoinjectors of different shape from that shown in the drawings.
Referring to Figure 1, the various components of the autoinjector, according to a first advantageous embodiment, are shown in an exploded manner. In this first embodiment, and in the order of numerical references, the autoinjector comprises a central body 1, a control ring 2, a stitching spring 3, a control sleeve 4, a piston rod 5, a support pad 6, three locking elements 7, here in the form of balls, an injection spring 8, a control slider 9, a lower body 10, an actuator sleeve 1 1, a spring 12 of the actuator sleeve, a housing of reservoir 13, a cover 14, an upper body 15, a plurality of planetary gear 16, a plurality of satellites 17, a delay spring 18, a trigger 19, a locking finger 20, a wire 21, an outer shell 22 and a locking ring 23. All these elements are part of the embodiment described, but not all are essential to the operation of the autoinjector, as will be more specifically described below.
A tank A can be inserted into said autoinjector. This reservoir contains fluid, and comprises a piston and a needle. The piston is adapted to move in said reservoir to inject the fluid through said needle. The present description will be made with reference to a syringe A, which can be of any type. More generally, it is understood that the term "syringe" in this specification encompasses any type of tank associated with a needle.
When the user wants to use the autoinjector, he takes the device, for example at the outer shell 22 and he presses the actuator sleeve 1 1, which in a first projected position protrudes out of the lower body 10, against the part of the body where he wants to perform the injection. In FIG. 2b, it can be seen that the pressure exerted by the user on the actuator sleeve 11 causes the latter to slide towards the inside of the body. 10, with the effect of compressing the spring of the actuator sleeve 12.
Said actuator sleeve 1 1 comprises a flexible tab 1 10 which has a double flexibility. It is on the one hand radially flexible, that is to say that it deforms towards the inside of the actuator sleeve 1 January. She is then also laterally flexible that is to say that it deforms in the peripheral direction of the actuator sleeve 1 January. An actuator sleeve January 1 provided with such a flexible tab is simple to mold, which is favorable from the point of view of manufacturing costs. The flexible tab 1 10 advantageously comprises a portion of rod 1 1 1 which is flexible and which ends with a head portion 1 12. Said flexible tab 1 10 is adapted to deform on the one hand radially and on the other hand laterally relative to said central body 1 when said actuator sleeve 1 1 is moved from its first projected position to its actuated position and then from its actuated position back to its second projected position. Preferably, said flexible lug 1 is deformed radially when said actuator sleeve 1 1 moves from its first projected position, before actuation, to its actuated position, and said flexible lug is laterally deformed when said actuator sleeve 1 1 moves. from its actuating position to its second projected position, at the end of use. It is this variant which is represented in the figures.
The central body 1 comprises a first groove 101, substantially axial, and an opening 103, separated from said first groove 101 but disposed in the axial extension of said first groove 101. Said central body 1 also comprising a radial cam 102 disposed between said first groove 101 and said opening 103. As visible in particular in FIGS. 6 and 7, said radial cam 102 may be formed by an inclined radial thickening of the wall of the central body 1, said thickening being formed at the axial end of the first groove 101. Said radial cam 102 cooperating with said head 1 12 of said flexible tab 1 10 to radially deform said flexible tab 1 10 and thus allow said head 1 12 to pass from said first groove 10 to said opening 103 during the displacement of the actuator sleeve 1 1 to its actuating position.
Said central body 1 comprises a final receiving zone 105 offset axially and laterally with respect to said opening 103. As can be seen in the figures, this final receiving zone 105 is disposed axially approximately at the level of said first groove 101. The opening 103 is connected to said final receiving zone 105 by a laterally inclined groove 104. An axial shoulder 106 is provided between said final receiving zone 105 and said inclined groove 104. Thus, when said actuator sleeve 11 returns from its actuating position towards its second projected position, said head 1 12 of the flexible tab 1 10 slides in said laterally inclined groove 104, thereby laterally deforming said flexible tab 1 10. When said actuator sleeve 1 1 reaches its second projected position, after use, said head 1 12 snap under said axial shoulder 106, thereby locking said actuator sleeve 1 1 relative to said central body 1 and relative to the lower body 10. From this locked position, said actuator sleeve can no longer be moved towards its actuating position, from the stop formed between the head 1 12 of the flexible tab 1 10 and the axial shoulder 106.
Figures 4 to 8 show the starting position, that is to say when the user will start using the autoinjector. It can be seen in these figures that the head 1 12 is disposed in said axial groove 101 of the central body 1. When the actuator sleeve 1 1 slides inwardly of the lower body 10, said head 1 12 of the flexible tab 1 10 will slide inside said groove 101 of the central body. When the head 1 12 reaches the axial end of the first groove 101, said radial cam 102 will cooperate with said head 1 12. This radial cam 102 will deform the flexible lug 1 10, and in particular its stem portion 1 1 1, radially inwardly towards its longitudinal central axis.
In this actuating position, the flexible tab 1 10 resiliently returns to its radially undeformed position. The head January 12 of the flexible tab 1 10 then enters the interior of said opening 103 as visible in Figure 14.
The radial deformation of the flexible tab 1 10, necessary to move the actuator sleeve from its first projected position to its actuated position, generates a certain resistance. Combined with the compression force of the spring 12, this resistance forces the user to exert at least one predetermined force to effect the displacement of the actuator sleeve 1 1 inside the lower body 10. This avoids any risk of accidental actuation or undesired after removal of the cover 14. The actuation takes place only if the user exerts said predetermined force on the actuator sleeve 1 January. This force threshold also creates a certain precompression in the hand of the user, with the effect that when this threshold is reached, the movement of the actuator sleeve 1 1 to its actuating position is guaranteed.
When the actuator sleeve 1 1 reaches its actuating position, that is to say in the position of Figures 13 to 16, the spring 12 of the actuator sleeve has been compressed and the stitching lock is triggered by said actuator sleeve 1 1, as will be more fully described later, which causes the movement of the syringe A inside the lower body 10 and thus the stitching of the needle into the body of the user. During all this stitching phase as well as during the injection phase following said stitching phase, the actuator sleeve 1 1 does not move relative to the lower body 10, since the user maintains its pressure on the part of the body in which he performs the injection.
At the end of use, when the user withdraws the autoinjector from his body, the spring 12 of the actuator sleeve 1 1 will urge said actuator sleeve 1 1 back from its actuating position to its second projected position, as is shown in Figure 3c. During this axial displacement back of the actuator sleeve 1 1 in the lower body 10, the head 1 12 of the flexible lug 1 10 will cooperate with the inclined groove 104 as visible in Figures 17 and 18. This will cause an elastic deformation of the flexible lug 1 10, and in particular its rod portion January 1, as the actuator sleeve 1 1 will slide axially, the head 1 12 sliding in said inclined groove 104 laterally deforming said flexible lug 1 10 as visible This inclined groove 104 terminates in a final receiving zone 105 provided with an axial shoulder 106. At the end of the return stroke of the actuator sleeve 1 1, the head 1 12 of the flexible lug 1 10 to enter this final receiving zone 105 and the upper edge 1 14 of the head 1 12 will come to cooperate with the axial shoulder 106, which will block the actuator sleeve 1 1 relative to the lower body 10. The man the actuator 1 1 can not then slide axially inwardly of the lower body 10, and the safety device is then in the locked final position. Thus, the needle is completely protected after use and the user can no longer use the autoinjector or injure himself with the needle.
FIGS. 32 to 46 more particularly describe the device for moving the syringe in the lower body 10. This device for displacement ensures on the one hand stitching, that is to say the insertion of the needle into the body of the user, and on the other hand the retraction of the needle after injection.
As we have seen previously, at the beginning of actuation, the syringe A is moved axially in said lower body 10 to carry out the insertion of the needle into the body of the user. After injection of the fluid product into the body of the user, and possibly after a certain delay provided by the retarding device described above, the syringe A is again moved in the other direction inside the lower body 10, to be retracted and thus automatically remove the needle from the body of the user. In this way, when the user removes the autoinjector from his body, the needle is no longer projecting but instead retracted inside said autoinjector.
To perform these movements back and forth of the syringe A in the lower body 10, there is provided a control ring 2 which cooperates with the control sleeve 4, with the control slider 9 and with the actuator sleeve 1 1. Furthermore, the trigger 19 intervenes to achieve the retraction of the syringe inside the body as will be explained below.
When the actuator sleeve 1 1 arrives in its end position inside the lower body 10, as shown in FIG. 3b, a shoulder 11 of said actuator sleeve 1 1 will cooperate with a shoulder 92 of the control slide 9 for axially moving said control slide 9 upwards in FIG. 36. This displacement axial direction of the control slider 9 will release the rotation of the control ring 2 which will be rotatable under the effect of its charged stitching spring 3.
The control ring 2 comprises a first inclined inner profile 24, such as a ramp, which will cooperate with a projection 44 of the control sleeve 4. Thus, the rotation of the ring 2 will progressively move axially said control sleeve 4. This control sleeve 4 cooperates with the syringe housing 13 which receives the syringe, and thus a displacement of the control sleeve moves the syringe A into the lower body 10 to perform the stitching of the needle.
During the displacement of the control sleeve 4 and thus the insertion of the needle into the body of the user, the projection 91 of the control slider is also in contact with an external inclined profile 25 of the ring 2, such as an external ramp, which will cause additional axial movement of said control slider 9 relative to the actuator sleeve 1 January. This will move the control slider 9 in the same direction as the actuator sleeve 11 during stitching. As a result, the projection 92 of the control slider 9 comes close to an upper projection 1 19 of the actuator sleeve 1 1, and the projection 95 of the control slider 9 comes close to a projection
191 of the trigger 19, as visible in Figure 44.
The first internal inclined ramp 24 which cooperates with the projection 44 of the control sleeve 4 advantageously comprises a plate 241, that is to say a non-inclined portion, visible in FIG. 41. This dish 241 has a very important function since it ensures that the beginning of the injection will occur only after the complete end of the needle insertion into the body of the user. While for many autoinjectors it is necessary to begin the injection a little before the needle reaches its final insertion point, for reasons of manufacturing tolerance, the plate 241 on the ramp 24 avoids this phenomenon. Indeed, while the ring 2 has already completely moved the control sleeve 4 axially and thus has achieved the total insertion of the needle of the syringe into the body of the user, it is necessary that the ring 2 turns again. on the arc formed by said flat, for example about 30 °, to trigger the injection lock. Thus, the locking ring 23 of the injection lock is moved out of its locking position only after the additional rotation of the ring 2 on the circular arc formed by said plate 241. During this additional rotation, there is no axial displacement of the control sleeve 4, and therefore of the syringe A, since the plate 241 is not inclined. Even with manufacturing tolerances, it is thus ensured that the insertion is completed before the injection begins. Meanwhile, during this additional rotation of the control ring 2, a second internal inclined profile 26, such as a ramp, of the control ring 2 will cooperate with a projection 235 of the locking ring 23 of the injection lock. and move the latter out of its locking position to release the injection, when the control ring 2 reaches the end of its additional rotation. This is also visible in Figure 41. Advantageously, the control ring 2 comprises three second internal inclined profiles 26 arranged at 120 ° from each other, and the locking ring 23 comprises three projections 235 also arranged at 120 ° from each other, a respective projection 235 cooperating with a second respective internal inclined profile 26.
With the control slider 9 in the position of FIG. 44, if the user removes the autoinjector from his body while the injection is in progress or after injection but before the end of the retarder, the spring 12 of the actuator sleeve 1 1 will urge said actuator sleeve 1 1 back out of the lower body 10. This movement of the actuator sleeve 1 1 will pull the control slider 9 axially downwards in FIG. 44 by the cooperation between the upper shoulder 1 19 and the projection 92 of the slider. Thus, the control ring 2 will again be released in rotation by the control slider 9, and the spring 3 will urge this control ring further in rotation which will cause the retraction of the syringe and the needle to the inside the body. The actuator sleeve 1 1, at the end of movement, will be locked as described above. Thus, even if the user removes the autoinjector before the end of dispensing the product, the needle safety device is operative.
In normal operation, the injection ends and as will be described below, the piston rod 5 will release the rotation of a trigger 19, possibly with a certain delay if a delay device is used. From the moment when the trigger 19 has made a predefined rotation, a projection 191 of the trigger 19 will cooperate with the upper shoulder 95 of the control slider 9, and the control slider 9 will be moved axially downwards in FIG. 44, which will release the rotation of the control ring 2 as previously described.
Figures 19 to 26 schematically illustrate an advantageous injection lock. The autoinjector comprises injection means, comprising in particular the piston rod 5, the injection spring 8 and the locking ring 23, these injection means being locked in a position loaded by said injection lock. The unlocking of said injection lock then causes the actuation of said injection means and thus the injection of the fluid product through the needle. As shown in FIG. 19, said injection lock comprises a control sleeve 4 disposed in said central body 1, said control sleeve 4 containing said piston rod 5 and said injection spring 8, said piston rod 5 comprising a radial recess 50 receiving at least one locking element 7 movable between a locking position and an unlocking position. Said at least one blocking element 7 is preferably of substantially spherical shape. In the variant shown, there are three blocking elements 7 in the form of balls, but a different number of locking elements and somewhat different shapes of these locking elements are possible. The following description will nevertheless be made with reference to three balls, without this being limiting. Said balls 7 are biased radially outwardly by said piston rod 5 and are retained in the locking position by a locking member, which in this embodiment is formed by a locking ring 23. This locking ring 23 is axially displaceable relative to said piston rod 5 between a locking position, in which it holds the locking elements 1007 in the locking position, and an unlocking position, wherein said locking elements 1007 are released to thereby unlock said lock injection, allowing said injection spring to move said piston rod 5 to its injection position.
Figure 20 shows the injection lock in the locking position. The injection spring 8 cooperates on the one hand with the piston rod 5 and on the other hand with a support pad 6. This support pad 6 is formed by a ring disposed around said piston rod 5. The piston rod 5 comprises a peripheral recess 50, advantageously provided with an inclined surface 51, formed by a narrowing of the diameter of said piston rod 5. This piston rod 5 is disposed inside the control body 4 and is capable of move axially to the left in FIG. 20 to push the plunger of syringe A inside the syringe and deliver the fluid contained in said syringe through the needle. As can be seen in FIG. 20, the balls 7 are disposed in said recess 50 formed in the piston rod 5 and thus cooperate with the inclined wall 51 of the piston rod 5 and with the upper surface on the one hand. 61 of said support pad 6.
The locking ring 23 is provided radially outside the balls 7 to radially block said balls in the locking position. Referring more particularly to FIG. 22, it can be seen that the balls may be arranged in housings of the control sleeve 4, the locking ring 23 comprising projections 231, one for each ball
7, which are positioned in contact with the balls 7 to prevent them from being moved radially outwardly.
It should be noted that the balls 7 could be replaced by non-spherical elements but with a rounded shape that is more complex, for example example in the form of cylinder or bean, to further improve the stability of the lock. In this case, these non-spherical movable elements could be made of metal, for example by cutting steel wire.
When the needle of the syringe has completely penetrated the body of the user, and only after this total insertion, as will be described later, the locking ring 23 is moved according to the arrow E1 in FIG. This has the effect of releasing the balls 7 from their locking position, these being then displaced radially outwardly along the arrow E2. Alternatively, the locking ring 23 could also be rotated to a position where it releases the balls. The support pad 6 then abuts against an inner edge of the control sleeve 4 as represented by the arrow E3 in FIG. In this position, the piston rod 5 is no longer retained by the balls 7 and is thus moved axially, that is to say to the left in Figure 21, to perform the injection of the product. The balls 7 can no longer return to the blocking position, prevented by the patch 6, as visible in FIG. 21.
When the injection is complete, that is to say when the piston rod 5 has reached its end position in which the piston of the syringe A has been moved to inject the fluid, a trigger 19 is actuated to retract the syringe and thus the needle. During the injection phase, a locking finger 20 extends through the trigger 19 and into the central channel 151 of the upper body 15. A delay spring 18, here a spiral spring, biases said trigger 19 in rotation. This rotation is blocked by the locking finger 20, advantageously of oblong shape, which is adapted to rotate together with said trigger 19, but which is blocked in rotation by said central channel 151 of the upper body 15. During the injection phase, the piston rod 5 moves axially, that is to say to the left in FIG. 28. As it moves, it will pull on the wire 21 which will therefore extend out of the channel 151. As long as the locking finger 20 is disposed inside the central channel 151, the rotation of the trigger 19 is blocked. When the piston rod 5 approaches the end of injection stroke, the wire 21 is completely pulled and stretched between the piston rod 5 and the locking pin 20, and any further displacement of the piston rod 5 will therefore move axially the locking finger 20 out of said central channel 151. When the piston rod 5 reaches end of injection end position, the locking finger no longer cooperates with the central channel 151, and the trigger 19 and the locking finger can then rotate under the effect of the retarding spring 18 As can be seen in FIG. 31, the trigger 19 comprises an inclined external ramp 190 which may comprise on one side a projection 191. When the trigger 19 has made a predefined rotation, typically about a turn, this projection 191 will cooperate with the control slider 9, which will move it axially and thus trigger the retraction of the needle, as has been previously described.
This delaying device, which is optional in an autoinjector, is mainly intended to shift in time the retraction of the syringe A and therefore the needle out of the body of the user after the end of the injection of the fluid product. inside said body. This allows in particular a diffusion for a few seconds of the product after its injection. Such a retarder also provides a benefit to the user, who no longer has to count, for example up to 10, after its injection, the time taken for this count can be very variable from one user to another. With a self-timer, the sequence of use of an autoinjector is facilitated.
Figure 27 illustrates an exploded schematic view of this delay device. This comprises the upper body 15, several planetaries 16 with several satellites 17, the delay spring 18, the trigger 19, the locking pin 20, the wire 21 and the piston rod 5. It is this piston rod 5 which will perform the actuation of the delay device when it reaches the end of the injection stroke with all the product that has been injected.
Figure 28 shows the delay device before it is actuated. It can be seen that the actuating rod 5 is connected to the locking finger 20 via the wire 21. In this position, the wire 21 and the locking finger 20 extend inside a central channel 151 of the upper body 15 and in the trigger 19. The upper body 15 has a gear 155 on its lateral internal surface, as shown clearly in FIG. 30. This internal gear 155 of the upper body 15 cooperates with a plurality of satellites 17 which are assembled on planetary gears 16. In the example shown in FIG. 28, there are several planetary axles stacked axially. on the other. The planet gears 16 comprise a disk-shaped plate on which satellite support rods 161 are formed on one side, each of which receives a satellite 17 in rotation. In the example shown, there are three satellites 17 on each stage. so that there are three rods 161. Each sun gear 16 associated with its satellites 17 forms a stage of the delaying device. On the other side of the disk-shaped plate, the sun gear 16 has a gear 162 adapted to cooperate with the satellites 17 of the adjacent stage. Thus, as shown in FIG. 30, the delaying device uses the principle of epicyclic gear trains. Each stage of this device makes it possible to increase and / or slow down the rotations of the previous stage. When a delay device is used, the trigger 19 cooperates with a first sun gear 16, whose rods 161 extend inside said trigger 19. The gear 162 of the first sun gear 16 then cooperates with the satellites of a second planetary adjacent, which cooperate with the lateral gear 155 of the upper body 15, thereby multiplying the rotation of the first sun gear and therefore the trigger, and thus curbing this rotation. Each additional stage of the epicyclic gear train forming the retarder will further reduce these rotations, and thus further reduce the rotation of the trigger 19. Thus, with four stages as shown in the figures, it is possible to reduce the rotation of the trigger 19 to a single revolution while the last sun gear 16 disposed at the bottom of the upper body 15 will simultaneously perform about fifty turns.
Depending on the number of stages and / or on the number of satellites and / or on the shape of the sun wheels and / or on the dimensions of the gears in play, the delay between the moment when the delay device is triggered and the moment when the trigger 19 has achieved its predefined rotation to trigger the retraction of the syringe, as will be explained later. Friction braking can also be provided, for example between the satellites 17 and the internal gear 155 of the upper body 15.
It should be noted that the principle of the deployable wire connected on the one hand to the piston rod 5 and on the other hand to the locking pin 20 can be used without the epicyclic gear system as shown in FIGS. 27 to 31 , as will be described in particular below with reference to the second embodiment. This thread, very compact, ensures that the retraction of the needle does not begin until the injection phase is completely completed, allowing in particular to compensate for any manufacturing tolerances. More generally, the use of a wire reduces the size of the device. As a result, it can be used advantageously for different functions in an autoinjector, since it is necessary to draw a piece relative to another.
Thus, as can be seen in FIGS. 2a to 2f, the outer shell 22 may comprise several viewing windows, in this case three windows 221, 222, 223, which make it possible to visualize moving elements during the various phases of actuation, these elements with indicators, typically colors.
Thus, the control slider 9, which at rest is in a first position relative to the central body 1, moves axially towards a second position during the displacement of the actuator sleeve 1 January. It then remains in this second position during the whole injection phase, and returns towards its first position during the retraction of the needle. Only when the actuator sleeve returns to its second projected position, the control slider reaches this first position. This control slider 9 may comprise one or more color indicators, for example a red horn zone visible in FIG. 1. This slider can therefore be used to indicate on the one hand the projected position of the actuator sleeve 1 1 (first position) and secondly the stitching and injection phase (second position).
Thus, the first viewing window 221 may be the end of injection window, that is to say that when a predefined color, for example red, appears in the window 221, the injection is completed and the syringe has been retracted. The user therefore knows that when this first window of visualization is red, it can remove the autoinjector safely from his body. This indication may for example be provided by the trigger 19.
In this configuration, the combination of the red in the first and third viewing windows 221 and 223 guarantees the end of the process of using the autoinjector, with the needle retracted and the actuator sleeve 1 1 locked, which guarantees safety optimal. Of course, other display or indication means are also possible, and said outer shell 22 may comprise any number of viewing windows, of any shape and size, and which could be positioned differently from the represented variant. in the figures. A single window can display several different functions.
Optionally, in the first viewing window 221 or in another viewing window, for example an additional viewing window, it is possible to display the state of the delaying device, for example with a countdown. This could be achieved for example with numerical values written on the external lateral edge of the trigger which passes gradually into an appropriate viewing window and which displays in seconds the timer count. Other variants are of course also possible.
Figures 47 to 74c illustrate several variants of a second embodiment of the invention. This second embodiment relates to a simplified autoinjector, consisting of fewer parts, and therefore simpler and less expensive to manufacture and assemble. In the variant of FIG. 47 of this second embodiment, the autoinjector comprises a lower body 1010, an actuator sleeve 101 1, a spring 1012 of the actuator sleeve, a cover 1014, a control sleeve 1004, a piston rod 1005, a support pad 1006, three locking elements 1007, here in the form of balls, an injection spring
1008, a click member 1500, a wire 1021, and an outer shell 1022.
The main difference of this second embodiment is that the reservoir, in this case the syringe A, is fixed with respect to the lower body 1010, with respect to the control sleeve 1004 and with respect to the outer shell 1022. to perform the stitching of the needle, only the actuator sleeve slides relative to the rest of the autoinjector. There is therefore not in this second embodiment of syringe displacement device. Figures 48a to 48e illustrate the sequences of the use of the autoinjector of Figure 47.
When the user wants to use the autoinjector, he takes the device, for example at the outer shell 1022 and presses the actuator sleeve 101 1, which in a first projected position protrudes out of the lower body 1010, against the part of the body where he wants to perform the injection. In FIG. 48b, it can be seen that the pressure exerted by the user on the actuator sleeve 101 1 causes the latter to slide towards the inside of the lower body 1010, which discovers the needle and therefore its stitching due to the pressure exerted by the user on the autoinjector.
When the actuator sleeve 101 reaches its actuating position, which is its end position inside the lower body 1010, it causes the injection phase to be triggered, which is shown in FIGS. 48c and 48d. . It is found that the piston rod 1005 slides inside the syringe A pushing the piston thereof under the effect of the injection spring 1008. The product is distributed.
In this second embodiment, as can be seen in particular in FIGS. 49a to 52, said actuator sleeve 101 1 also comprises a flexible tab 11 which is flexible only laterally, that is to say that it does not deforms only in the peripheral direction of the actuator sleeve 101 1. An actuator sleeve 101 1 provided with such a flexible tab is still simpler to mold than the flexible double flexibility tab of the first embodiment, which is favorable from the point of view of manufacturing costs. With a flexible leg only laterally, it also gains in radial space, which allows in particular to improve the aesthetics of the autoinjector. The flexible tab 1 1 10 advantageously comprises a portion of rod 1 1 1 1 which is flexible and which ends with a head portion 1 1 12.
In a first variant, illustrated in FIG. 51, said flexible tab 1 1 10 is adapted to deform laterally with respect to said lower body 1010 on the one hand when said actuator sleeve 101 1 is moved from its first projected position towards its position d actuation and secondly when said actuator sleeve 101 1 is moved from its actuating position back to its second projected position. In this case, the head 1 1 12 of the flexible tab must overcome a resistance to deform laterally at the beginning of the actuation, to create a kind of precompression which ensures that when the actuator sleeve will slide inward of the lower body 1010, the needle goes constantly to the injection site to its desired injection position. In the example of Figure 51, this resistance is formed by a shoulder 1019 of the lower body 1010.
Preferably, however, in a second variant shown in Figures 50a, b, c and 52, said flexible lug 1 1 10 is not deformed when said actuator sleeve 101 1 moves from its first projected position, before actuation, to its actuating position, and said flexible tab is laterally deformed only when said actuator sleeve 101 1 moves from its actuating position to its second projected position, at the end of use. In this variant, before actuation, the actuator sleeve 101 1 is connected to said lower body 1010 by at least one breakable bridge 1500. This embodiment allows in particular easy molding, and therefore reduced manufacturing costs, adaptation and management of the breaking force of the breakable bridges facilitated by the dimensioning of these bridges, and a control function of use. Figure 52 illustrates two breakable bridges 1500, adapted to break and thus to allow a sliding of the actuator sleeve 101 1 relative to the lower body 1010 when the user presses the autoinjector at the injection site with a predetermined pressure.
When the actuator sleeve 101 1 returns from its second actuating position to its projected position, under the effect of the spring 1012, when the user removes the autoinjector from the injection site, the operation of the flexible tab 1 1 10 may be identical to that described in the context of the first embodiment, with an inclined groove, a final receiving zone and an axial shoulder cooperating with the head of the flexible tab to block it in the second projected position.
Alternatively, the lower body 1010 may include a shoulder 1019 which extends axially inwardly by a ramp 1018, for example formed by a rib, which is at least partially inclined. Thus, when the actuator sleeve 101 1 returns from its actuating position to its second projected position, the head 1 1 12 of the flexible tab 1 1 10 will be laterally deformed by said ramp 1018, to finally return to snap under the projection 1019 in the second projected position to lock the actuator sleeve.
It should be noted that the flexible lug 1 1 10 can be attached to said actuator sleeve 101 1 only at its rod portion 1 1 1 1, with in this case the head 1 1 12 forming a free end of said flexible tab. Alternatively, the flexible tab could also be attached to said actuator sleeve on both sides, thus with the head 1 1 12 disposed between the two attachment points. This implementation reinforces in particular the robustness of the leg flexible. This variant could also be adapted to the flexible tab of the first embodiment.
Figures 72 to 74c illustrate another alternative embodiment of the actuator sleeve. In this variant, the numerical references will be similar to those above, but increased by 1000. For example, the actuator sleeve will be referenced 201 1. In this particular variant, the functions of the actuator sleeve 201 1 and the body 2010 are reversed, the body 2010 comprising the flexible lug 21 10, and the actuator sleeve 201 1 having the profile which will cooperate with said flexible lug 21 10. The operation however remains similar to that described above, with the flexible tab 21 10 which will gradually slide in said profile, and in particular in an inclined groove 2104 which connects an opening 2103 to a final receiving area 2105. To lock the device at the end of actuated in the final receiving area 2105, the flexible tab 21 will snap onto the shoulder 2106, as shown in Figure 74c. As previously described, the flexible tab must advantageously overcome a resistance to deform at the beginning of the actuation, to create a kind of precompression which ensures that when the actuator sleeve 201 1 will slide inward of the lower body 2010, the The needle will constantly penetrate the injection site to its desired injection position. In the example of FIGS. 72 to 74C, this resistance is formed by a shoulder 2019 of the actuator sleeve 201 1. It should be noted that the flexible tab 21 can be integrally formed on the body 2010, or alternatively be formed on a separate part assembled on said body 2010, for example for reasons of simplification and / or molding. FIGS. 53a, b, 54a, b, 57a, b, c and 58a, b, c illustrate the adaptation to the second embodiment of the injection lock described in the first embodiment.
As shown in the various FIGS. 53, 54, 57 and 58, said injection lock comprises a control sleeve 1004 disposed in said outer shell 1022, said control sleeve 1004 containing said piston rod 1005, said injection spring 1008 and a support pad 1006. In the locking position shown in the various figures 53 and 57, the injection spring 1008 cooperates on the one hand with the piston rod
1006 is formed by a ring disposed around said piston rod 1005. Said piston rod 1005 comprising at least one radial recess 1050 receiving at least one locking element 1007 movable between a locking position and an unlocking position. Advantageously, there are three locking elements 1007, preferably of substantially spherical shape, in particular in the form of balls, but a different number of locking elements and different rounded shapes of these locking elements are possible. Said locking elements 1007 are biased radially outwardly by said piston rod 1005 and are retained in the locking position by a locking member, which in this second embodiment is formed by said control sleeve 1004. This sleeve control 1004 is axially movable relative to said piston rod 1005 between a locking position, in which it holds the locking elements 1007 in the locking position, and an unlocking position, in which said locking elements 1007 are released. thereby to unlock said injection lock, allowing said injection spring to move said piston rod 1005 to its injection position.
The central part 1501 is connected to said piston rod 1005 by said wire 1021, which is fixed on the one hand to said central part 1501 and on the other hand on said piston rod 1005. In the lock position of the injection lock, before the start of the injection, the wire 1021 is wound around the piston rod and the central part 1501 is disposed outside the sleeve 1004. When the control sleeve 1004 is moved to its unlocking position, shown in particular in FIG. 58a, an upper edge of said control sleeve 1004 comes into contact with said lateral parts 1502. During the injection, when the piston rod 1005 moves relative to the control sleeve 1004, the wire 1021 will gradually unfold until it is stretched at the end of injection as shown in Figure 58b. From this moment, the wire 1021 will exert traction on the central part 1501, causing under the effect of the reaction of the upper edge of the control sleeve 1004, the displacement and / or the deformation of the side pieces. In the example shown with breakable connections 1503, these break, allowing the lateral parts 1502 to move above the central part 1501, and thus the control sleeve 1004 to move axially relative to the outer shell 1022, as visible in particular in Figure 59a. This displacement is done under the pressure exerted by the injection spring 1008 on the control sleeve 1004, it is relatively abrupt and creates a shock between the control sleeve 1004, the side parts 1502 and / or the outer shell 1022. This shock is audible and / or tactile for the user, which therefore receives information on the end of injection. After actuation of this audible and / or tactile indication device, the wire 1021 is no longer quite taut, as illustrated schematically in FIGS. 59a and 59b.
Figures 60 to 64c illustrate a second variant of the sound and / or tactile indication device. In this second variant, the central piece is removed. The audible and / or tactile indication device 1500 comprises a movable element which is here formed by the control sleeve 1004, which comprises at its end distal to the needle, one or more deformable tabs 1510 which at the end of FIG. injection will abut against the outer shell 1022. This control sleeve 1004 is in a first position relative to the outer shell 1022 before actuating the autoinjector, as shown in Figure 64a. Upon actuation, the opening of the injection lock, and therefore the beginning of the injection phase, causes the displacement of the control sleeve 1004 to a second position, visible in Figure 64B. A central part called key 1 120 here advantageously replaces the wire of the first previous variant. This key 1120, in particular visible in Figures 63a and 63b, comprises a rod portion 121 which extends inside the piston rod 1005, this rod portion being similar to the wire of the first variant. Key 1 120 also has a head portion 122, disposed at the upper (or distal to the needle) end of said key. This head portion cooperates with said deformable tabs 1510 of the control sleeve 1004, to prevent them from deforming radially inwardly. As a result, these deformable tabs 1510 block said control sleeve in its second position with respect to said outer shell
1022. The lower end (or proximal relative to the needle) of the rod portion 1 121 cooperates with the piston rod 1005 at the end of injection, causing a sliding of said key 1 120 relative to the sleeve of 1004 control and the outer shell 1022. Thus, after this sliding, the head portion 122 122 no longer cooperates with the lugs 1510 of the control sleeve, which can then deform radially inwardly. This has the effect of unblocking the control sleeve 1004, which is then moved to a third position against said outer shell 1022 under the effect of the force exerted by the injection spring 1008. This creates an audible or otherwise detectable shock by the user, who knows then that the injection is complete.
Advantageously, the outer shell 1022 comprises one or more, in particular three viewing windows 1023 in which said deformable tabs 1510 become visible at the same time as they come to tap against the outer shell. This allows a visual indication simultaneously with the sound and / or tactile indication. Advantageously, said at least one viewing window 1023 is formed on or in the distal end edge of said outer shell 1022, being visible both in the axial direction and in the radial direction of said shell. This implementation avoids masking the viewing window (s) 1023 when the autoinjector is taken over by the user, which guarantees a good visualization of the information displayed in said at least one viewing window 1023 during the entire phase of the display. use, from beginning to end. With several viewing windows 1023, including three, distributed around the distal end edge of the body 1022, perfect viewing is guaranteed regardless of the orientation of the autoinjector at the time of use.
The alternative embodiments of the second embodiment of the autoinjector described above thus define a control sleeve 1004 having three distinct positions: before injection when it is in the locking position, during injection when it is in the unlocking position, and after injection when he has actuated the audible and / or tactile indication device. This makes it easy to visualize these three distinct positions in an appropriate viewing window 1221. Of course, the outer shell 1022 of this second embodiment could furthermore include several viewing windows as described in the first embodiment.
Figures 69 to 71 illustrate in more detail the operation of the audible and / or tactile indication device. In Fig. 69, the deformable tab 1520 is prevented from deforming radially inwardly by the presence of the head portion 122 of the wrench 1120. In Fig. 70, the wrench has been moved by the piston rod. and, therefore, the deformable tab 1520 has deformed radially inwardly. This caused the displacement of the support pad 1006 in the outer shell, with a shoulder 1521 of the deformable tab which abuts on a portion of said outer shell, generating the sound and / or tactile indication, for example an audible sound or a sensible vibration. Simultaneously, the end of the deformable tab 1520 is positioned in the window 1023 of the outer shell 1022, as can be seen in FIG. 70. FIG. 71 illustrates the end of the injection, with the piston rod 1005 which will pulling on the shank portion 1 121 of the key 1 120 to move it.
Although the present invention has been described with reference to several advantageous embodiments and variants, which combine several functional modules, it is understood that the various modules described can be used independently of each other. In particular, the actuator sleeve and / or the syringe displacement device for the stitching and / or the retraction and / or the injection lock and / or the delay device and / or the sound and / or tactile indication device may be used independently of each other. Stitching of the needle and / or retraction of the needle after injection could be controlled by one or more button (s). The audible and / or tactile indication device of the second embodiment could be used with an autoinjector of the type described in the first embodiment. Other modifications are also possible for those skilled in the art without departing from the scope of the present invention as defined by the appended claims.
1 .- autoinjector comprising an outer shell (1022), a reservoir containing fluid and comprising a piston and a needle, such as a pre-filled syringe (A), said autoinjector comprising a piston rod (1005) adapted to cooperating with the piston of said reservoir, said piston rod (1005) being movable between a loaded position and an injection position in which said piston rod (1005) has moved the piston of the reservoir to inject the fluid through the needle, an injection spring (1008) being provided for biasing said piston rod (1005) towards its injection position, the autoinjector comprising a movable member (1004; 1006), at least partially containing said piston rod ( 1005) and said injection spring (1008), said piston rod (1005) being displaceable with respect to said movable element (1004; 1006) during the injection phase, characterized in that said autoinjector comprises a device an acoustic and / or tactile indication device (1500) having a key (1120), said key having a rod portion (121) which extends within the piston rod (1005), and a head portion (1122), said movable member having at least one deformable tab (1510; 1520), said head portion (1122) of said key (1120) cooperating prior to injection with said at least one deformable tab (1510; 1520) to prevent any radial deformation thereof, blocking said movable member (1004; 1006) relative to said outer shell (1022), said piston rod (1005), at the end of injection, exerting via said shaft portion (1 121) of said key (1 120) traction on said head portion (1 122) of said key (1120), causing said key (1120) to move relative to said at least one deformable tab (1510; 1520), thereby allowing radial deformation of said at least one deformable tab ( 1510; 1520) and an axial displacement of said movable member (1004; 1006) under the effect of said injection spring (1008), said displacement generating a sound and / or tactile indication for the user.
An autoinjector according to claim 1, wherein said movable member is a control sleeve (1004) having one or more deformable tabs (1510).
An autoinjector according to claim 1, wherein said movable member is a support pad (1006) having one or more deformable tabs (1520).
4. An autoinjector according to any one of the preceding claims, wherein the sound and / or tactile indication is generated by the contact between said movable member (1004; 1006) and said outer shell (1022).
5. - autoinjector according to any one of the preceding claims, wherein said outer shell comprises at least one window (1023) providing a visual indication simultaneously to the sound and / or tactile indication.
An autoinjector according to claim 5, wherein said at least one window (1023) is disposed on the end edge of said outer shell (1022), said at least one deformable tab (1510; 1520) being visible in said at least one window (1023) after the end of the injection.
7. - Autoinjector comprising an outer shell (1022), a reservoir containing fluid and comprising a piston and a needle, such as a pre-filled syringe (A), said autoinjector comprising a piston rod (1005) adapted to cooperating with the piston of said reservoir, said piston rod (1005) being movable between a loaded position and an injection position in which said piston rod (1005) has moved the piston of the reservoir to inject the product fluid through the needle, an injection spring (1008) being provided to urge said piston rod (1005) towards its injection position, the autoinjector comprising a control sleeve (1004) containing said piston rod (1005) and said injection spring (1008), said piston rod (1005) being displaceable relative to said control sleeve (1004) during the injection phase, characterized in that said autoinjector comprises a device of audible and / or tactile indication (1500) comprising a central piece (1501) connected to said piston rod (1005) by a wire (1021), said central piece (1501) being connected to at least one side piece (1502) by a foldable and / or breakable connection
(1503), said piston rod (1005) being, at the end of injection, adapted to exert via said wire (1021) traction on said central piece (1501), causing deformation and / or breakage of said at least a foldable and / or breakable connection (1503) and thus the deformation and / or displacement of said at least one lateral piece (1502), thus permitting axial displacement of said control sleeve (1004) under the effect of said spring of injection (1008), said displacement generating a sound and / or tactile indication for the user.
8. An autoinjector according to claim 7, wherein said central piece (1501) comprises two side pieces (1502) each connected to said central piece (1501) by a breakable connection (1503).
An autoinjector according to claim 7 or 8, wherein said central part (1501), prior to injection, is disposed around said piston rod (1005), outside said control sleeve (1004).
An autoinjector according to any one of claims 7 to 9, wherein the audible and / or tactile indication is generated by the contact between said control sleeve (1004) and said at least one side piece (1502) and / or by the contact between said at least one side member (1502) and said outer shell (1022).
1 1 .- autoinjector according to any one of claims 7 to 10, wherein said central piece (1501) is formed as a cylindrical sleeve.
EP13731360.7A 2012-09-27 2013-05-24 Autoinjector Active EP2900299B1 (en)
PCT/FR2013/051144 WO2014049214A1 (en) 2012-09-27 2013-05-24 Autoinjector
EP17202883.9A EP3308814A1 (en) 2012-09-27 2013-05-24 Autoinjector
EP17202883.9A Division-Into EP3308814A1 (en) 2012-09-27 2013-05-24 Autoinjector
EP17202883.9A Division EP3308814A1 (en) 2012-09-27 2013-05-24 Autoinjector
EP2900299A1 true EP2900299A1 (en) 2015-08-05
EP2900299B1 EP2900299B1 (en) 2020-07-08
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Inventor name: FABIEN, DAVID
Inventor name: WALTER, MATTHIEU
Inventor name: MANSENCAL, ANTOINE
2017-05-24 B565 Issuance of search results under rule 164(2) epc
Ipc: A61M 5/00 20060101ALI20170418BHEP
Ipc: A61M 5/315 20060101ALI20170418BHEP
Ipc: A61M 5/31 20060101ALI20170418BHEP
Ipc: A61M 5/20 20060101AFI20170418BHEP
Ipc: A61M 5/32 20060101ALI20170418BHEP