EA029122B1 - Re-useable injector device for syringe - Google Patents

Abstract

An injector device includes an injector body that receives a syringe; and an injection assembly being configured to dispense medicament from the syringe in a dispensation step. Certain types of injector devices include a sudden completion indicator that indicates when the injection is completed. Certain types of injector devices are configured to dispense two different medicament formulations having different viscosities from syringes without making any changes to the injector devices other than to switch out the syringes. Certain types of injector devices include safety arrangements that inhibit firing of the injector device until front and rear housing assemblies are disposed in predetermined rotational and axial positions relative to each other.

Description

DESCRIPTION OF THE INVENTION TO THE EURASIAN PATENT (45) Date of publication and grant of the patent 2018.02.28 (21) Application number 201591666 (22) Date of filing of the application 2014.03.07 (51) Ιηί. C1. A61M5 / 20 (2006.01) (54) INJECTOR DEVICE OF REPEATED USE FOR THE SYRINGE (31) 13158407.0; 13 / 790,487; 2808875 (32) 2013.03.08 (33) EP; ϋδ; CA (43) 2016.01.29 (86) PCT / 1B2014 / 000860 (87) AO 2014/140820 2014.09.18 (71) (73) Applicant and patent holder:

TEVA PHARMACEUTICAL INDUSTRIES LIMITED (1) (72) Inventor:

Kou Toby (CB) (56) υδ-Ά1-20110202011 υδ-Ά1-20120107783 ΟΒ-Ά-2474308 ΑΟ-Ά1-2012145685 ΑΟ-Ά1-2012072552 (74) Representative:

Medvedev V.N. (Κϋ)

029122 B1

029122 Β1 (57) The injector device includes an injector body in which a syringe is housed; and also an injection unit configured to dispense the drug from the syringe at the dispensing stage. Some types of injection devices include an instant completion indicator that indicates that the injection is complete. Some types of injector devices are capable of dispensing from the syringe two different medicinal compositions having different viscosities without introducing any changes to the injector devices other than disconnecting the syringes. Some types of injection devices include protection circuits that prevent the injection device from tripping until the front and rear housing units are placed in predetermined rotational and axial positions relative to each other.

State of the art

The drug substance can be dispensed from the syringe using an injector device. Some injector devices are spring loaded, so the user only needs to activate the trigger to trigger the delivery of the drug. Some types of injection devices also automatically insert the needle into the injection site before dispensing the drug. For example, some types of injector devices trigger activation when the front of the injector device is pressed against the injection site. Some types of injection devices are disposable devices. Other types of injector devices are reusable by providing the ability to disconnect the expended syringe to replace the syringe. Some types of injector devices include indicators indicating how many times the injector device has injected a drug or how many drugs have been dispensed.

SUMMARY OF THE INVENTION

According to some aspects of the disclosure, the injector device includes: a first housing unit configured to hold a syringe; a second housing unit; locking link; as well as a deadlock assembly configured to pivotally attach the first housing assembly to the second housing assembly in a certain pivoting position. The second housing unit includes an outer case and an inner case. The inner housing is axially fixed relative to the first housing assembly. The outer casing is axially movable relative to the first casing assembly between the extended position and the retracted position. The second housing unit includes an injection unit configured to control the syringe to administer the drug from the syringe. The second housing unit includes a trigger link configured to start the injection unit only when the outer housing is in the retracted position. The second housing unit includes a deflector link biasing the outer housing to an extended position. The locking link rigidly holds the outer housing in the extended position.

The interlocking unit is configured to unlock the locking link, so that the outer housing is able to move relative to the first housing unit in a retracted position, counteracting the bias created by the deflecting link.

According to other aspects of the disclosure, the injector device includes: an injector body comprising a front assembly and a rear assembly that together form an interior space; syringe; as well as an injection unit located in the interior of the injector body. The front assembly includes a front housing, a syringe carrier capable of moving relative to the front housing between the rear position and the front position, a first damper located at the rear of the front housing, and a second damper located at the rear of the syringe carrier. The syringe carrier engages with the first damper while in the forward position, while the syringe carrier is spaced apart from the first damper while in the rear position. The syringe is made with the possibility of connection with the carrier of the syringe to move with it. The syringe includes an ampoule, needle and plunger. The needle continues from the first end of the ampoule, and the plunger continues from the second end of the ampoule. At least a portion of the ampoule is engaged with the second damper. The ampoule is configured to hold the universal volume of any of at least two different medicinal compositions without resorting to modification of the injector device. The first of these two different drug compositions has a first viscosity, and the second of these two different drug compositions has a second viscosity different from the first viscosity. The injection unit is configured to dispense a drug composition held by a syringe. The injection unit includes a pusher driven by a spring with constant stiffness. The release of the spring with constant stiffness causes the syringe carrier to move from the rear position to the forward position until the syringe carrier engages with the first damper. A spring with constant stiffness moves the plunger within the syringe ampoule after the syringe carrier has taken its forward position. The first and second dampers interact to prevent destruction of the ampoule during the movement of the syringe carrier and the movement of the plunger.

According to some aspects of the disclosure, the injector device includes an instant completion indication unit located in the interior of the injector body. The link indicating the instantaneous completion is arranged to move relative to the body of the injector between the first position and the second position. The link for indicating instant completion is visually inaccessible in the body of the injector, being in the first position, while it can be seen through the window when in the second position. The movement of the instant completion indicator link from the first position to the second position is initiated when the dispensing step is completed.

Various additional aspects of the invention will be set forth in the following description. Aspects of the invention may relate to individual elements or combinations of elements. It should be understood that both the foregoing general description and the following detailed description are given only as an example and are explanatory in nature, without limiting the general ideas of the invention,

- 1,029,122 of which the embodiments disclosed herein are based.

Brief Description of the Drawings

The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate certain aspects of the present disclosure. The following is a brief description of the drawings, which show:

in FIG. 1 is a front perspective view of one example of an injector device made in accordance with the principles of the present disclosure;

in FIG. 2 is a front perspective view of the injector device of FIG. 1, where the casing puller is removed from the injector device;

in FIG. 3 is an exploded view of the injector device of FIG. one;

in FIG. 4 is a side view of the injector device of FIG. 1, where the front node is axially separated from the rear node;

in FIG. 5 is an axial sectional view of the injector device of FIG. 4, where the front assembly is rotated so as to face the rear assembly;

in FIG. 6 is a side view of the injector device of FIG. 4, where the front end of the front node is inserted into the front end of the rear node to prepare the injection system of the injector device for operation;

in FIG. 7 is an axial sectional view of the injector device of FIG. 6;

in FIG. 8 is an axial section of the front assembly of the injector device of FIG. 1, where the syringe is loaded into the front assembly;

in FIG. 9 is an enlarged sectional view of the front end of the injector device shown in FIG. 1, where the syringe is loaded so that the front housing casing puller engages with the needle casing;

in FIG. 10 - the casing puller and the needle casing are removed from the injection device shown in FIG. 9;

in FIG. 11 is a side view of the front assembly of FIG. 10, where the syringe is loaded into it, and the casing puller is removed;

in FIG. 12 is a perspective view of the rear assembly of FIG. 4, which is shown in axial section and separated from the front assembly;

in FIG. 13 is a side view of the injector device of FIG. 1, while the rear housing is located in the extended position;

in FIG. 14 is a side view of the injector device of FIG. 13, where the rear housing is in a retracted position;

in FIG. 15 is an axial sectional view of the injector device of FIG. 13; in FIG. 16 is an axial sectional view of the injector device of FIG. fourteen; in FIG. 17 is a perspective view of an inner housing of a rear assembly located relative to a front assembly shown separated from an outer housing of a rear assembly such that a deadlock lever and a rearwardly extending foot are visible;

in FIG. 18 is an enlarged perspective view of the portion of FIG. 17;

in FIG. 19 is a rear perspective view of the front assembly of FIG. 16, where the lateral section of the deadlock lever is visible;

in FIG. 20 is a perspective view of a trigger button located around a protruding structure of an inner case;

in FIG. 21 is an axial sectional view of the injector device shown in FIG. 16, where the start button is pressed, the plunger of the injection unit is released from the cocked position, with the syringe carrier reaching a low point;

in FIG. 22 is an axial sectional view of the injector device of FIG. 21, where the plunger has reached a low point in the syringe, with the instant completion indicator in the forward position;

in FIG. 23 is a perspective view of the injector device of FIG. 2, where the syringe needle protrudes from the front of the injector device, and the completion indicator is located in the front position.

- 2 029122

Detailed description

Detailed references will now be made to examples of aspects of the present disclosure illustrated in the accompanying drawings. Where possible, the same reference numbers are used throughout the drawings to refer to the same or like parts.

In general, the disclosure is directed to a description of an injector device configured to hold a syringe and an injection unit. The injection unit is configured to dispense the drug substance from the syringe (i.e., the release of fluid from the syringe) at the dispensing stage. In some embodiments, the injection unit is also configured to move the syringe from the retracted position to the extended position to insert the syringe (i.e., insert the needle at the injection site) during the injection step. In some embodiments, an injection device may be used repeatedly. For example, the syringe may be removed after use and replaced with a new syringe.

In some embodiments, the injector device has a completion indicator indicating that a drug has been dispensed and that the user can remove the needle from the injection site. In some embodiments, the completion indicator is an instant completion indicator. For example, the completion indicator is only activated when the issue phase is completed. In the present description, the term at completion refers to a time frame containing the time of completion, the time immediately after the time of completion, as well as time intervals within a few milliseconds before and after completion (for example, due to tolerances in the operation of the injector device). Until completion, the display facility provided by the instant completion indicator does not change. In some embodiments, the instant completion indicator includes a window through which you can see the color change when output is complete. In some embodiments, the instant completion indicator makes an audible sound when output is complete. In some embodiments, the instant completion indicator includes both a color change and an audible sound.

In some embodiments, the injector device is configured to be used with syringes, which may have one of at least two different compositions. The composition used in syringes can be selected from these two compositions without resorting to adjusting the injector device. For example, an injector device may be used with a first syringe having 20 mg of a particular drug substance in a fixed volume. After the injection, the first syringe can be replaced by a second syringe containing 40 mg of the drug substance in the same volume. The injection device can inject and dispense the contents of the second syringe without any adjustment to the injection device.

In the same injection device, you can place either the first or second syringe. For example, the dimensions of the first syringe and the second syringe can be substantially identical. No need to resize, move or otherwise modify any part of the injector device to switch to another downloadable composition. For example, the same spring with constant stiffness, the same pusher location, and the same plunger depth can be used for both syringes. Thus, before each injection, the user can choose whether to load the first composition into the injection device or to load the second composition. The damping areas on the syringe carrier and the carrier holder prevent the destruction of the syringe during injection and dispensing. For example, damping areas can reduce the number of cases or the frequency of breakdown of the syringe (e.g., cracking, breaking and / or breaking of the ampoule, deformation or displacement of the needle cannula relative to the ampoule or other injuries of the syringe) during injection compared to syringes that do not contain damping areas.

In some embodiments, the injector device includes protection circuits that prevent the injector device from tripping until the injector device is correctly assembled, pressed against the injection site with a predetermined force, and the trigger mechanism is actuated. For example, pressing the start button of an injector device when a predetermined force is not applied to the injector device will not operate the injection unit to inject a syringe or dispense a drug. In some embodiments, the injector device includes a front assembly and a rear assembly that rotationally align and axially move toward each other before actuating the trigger mechanism launches the injection assembly.

In FIG. 1 and 2, an example of an injector device 100 extending between the front 101 and the rear 101 is shown. The injector 100 has opposed side surfaces 103 extending between the front 101 and the rear 101. In general, the injector 100 is configured to dispense a drug from the front portion 101 at startup on the rear portion 101. The injection device 100 also has opposed end surfaces 104 extending between the side surfaces 103 and between the front portion 101 and the rear part 101. In some embodiments, the side surfaces 103 have a larger

- 3 029122 lateral dimension than end surfaces 104.

The injector device 100 includes a front assembly 110 and a rear assembly 130 that are interconnected. The front assembly 110 is configured to hold the syringe 180 (FIG. 8). The rear assembly 130 is configured to hold the injection assembly 140 (FIG. 12). In some embodiments, the front and rear nodes 110, 130 may be detachably interconnected to provide access to the interior of the injector device 100. For example, the front node 110 may thread, lock, snap into, engage in a sliding fit on the rear node 130 or somehow otherwise detachably connect to it. Front Node Release

110 from the rear assembly 130 allows the user to replace the syringe in the front assembly 110.

As shown in FIG. 3, the front assembly 110 includes a syringe carrier 111 configured to slide in the carrier support 114 between the front and rear positions. The syringe carrier 111 is configured to hold the syringe 180 (FIG. 8) so that the front of the syringe 180 extends forward from the carrier 111 (see, for example, FIG. 10). When the syringe carrier 111 is in the rear position, the syringe 180 does not protrude from the front portion 101 of the injector device 100 (see, for example, FIG. 15). When the syringe carrier 111 is in the forward position, the syringe (i.e., at least a portion of the needle 185) protrudes from the front portion 101 of the injection device 100 (see, for example, FIG. 21). The carrier spring 116 biases the syringe carrier 111 toward the rear position. In particular, the first end of the carrier spring 116 abuts against the sleeve 113 of the syringe carrier 111, and the second end of the spring 116 abuts against the inner shoulder in the carrier support 114. The intermediate portion of the carrier spring 116 extends along the support section 112 of the syringe carrier 111.

In some embodiments, a damping structure 190 is provided on the syringe carrier 111 and the carrier support 114 to prevent destruction of the syringe 180 (FIG. 8) during injection and delivery (see, for example, FIG. 7). For example, damping structure 190 can reduce the risk of rupture of syringe 180 when syringe 180 is advanced in front assembly 110 and / or when plunger 182 (FIG. 8) is advanced in syringe 180. In some embodiments, damping structure 190 includes one or more dampers located on the front housing unit 110 and / or the carrier 111 of the syringe. In various embodiments, the dampers are made of an elastic material such as rubber, foam or gel.

In some embodiments, the first damper 192 is located at least on the rear facing surface of the carrier support 114 (FIG. 7). The first damper 192 is configured to engage with the syringe carrier 111 when the syringe carrier 111 is in the forward position. The first damper 192 absorbs the energy of the syringe carrier 111 when the syringe carrier 111 reaches a forward position. Thus, the first damper 192 prevents the transfer of energy to the syringe 180. In some embodiments, the second damper 196 is located on the carrier

111 syringes for engaging with syringe 180 (FIG. 7). The second damper 196 interacts with the first damper 192 to prevent the destruction of the syringe 180 when the syringe carrier 111 engages with the support of the carrier in the forward position and / or when the syringe plunger is fully pressed into the syringe 180.

In some embodiments, the first damper 192 includes one or more gasket sections located on the support of the carrier 114 and facing the carrier 111 of the syringe. In other embodiments, the first damper 192 is part of a grip 194 (FIG. 5), which also extends along the outer surface of the front assembly 110. In some embodiments, the grip 194 is a soft / resilient / compressible material (eg, rubber), obtained by multicomponent molding or otherwise formed on top of the outer part of the support 114 of the carrier. In some embodiments, the second damper 196 includes a spacer ring located in the through passage of the syringe carrier 111. In some embodiments, at least a portion of the second damper 196 is seated on the rear surface of the syringe carrier 111. The posterior end of the syringe 180 is seated on the second damper 196 (Fig. 9).

The front assembly 110 also includes a depth adjustment assembly that controls the distance the needle 185 (FIG. 10) of the syringe 180 protrudes from the front 101 of the injector device 100 during the injection. As shown in FIG. 3, the depth adjusting unit includes a depth regulator 117 located in a depth regulator body 122 connected to a support of the carrier 114. For example, the depth regulator 117 may form an external thread 118 that engages with the internal thread 123 of the housing 122 (FIG. 3). In some embodiments, the locking levers 119 of the depth adjuster 117 may interact with a grooved inner surface (FIG. 3) of the carrier support 114 to define discrete rotary positions of the depth regulator 117 relative to the housing 122. Each discrete rotary position corresponds to a different needle insertion depth. In other embodiments, a grooved inner surface may be provided on the controller body 122.

- 4 029122

Signs 121 (FIGS. 1 and 2) are provided on the outer surface of the depth controller 117 to indicate how far the needle protrusion is set. For example, a series of numbers indicating a length or distance may be arranged in a spiral around the outside of the depth controller 117. The controller body 122 forms a window 124 through which the depth controller 117 is visually accessible (FIG. 1). As the depth gauge 117 passes along the thread along the regulator body 122, the characters 121 are cyclically repeated in the window 124. In some embodiments, the characters 121 are spaced apart to correspond to discrete rotational positions defined by the grooved inner surface 115 of the support 114 of the carrier. For example, in some embodiments, a new mark 121 can be seen through window 124 at each pivoting position of the depth adjuster 117. In other embodiments, the new sign 121 becomes visible at predetermined pivot positions. In some embodiments, the characters 121 are large enough to make it easier for the user to read the character 121. For example, at least some characters 121 may have a height of 4 mm.

The depth regulator 117 forms a gripping surface 120 (FIG. 2) in the direction of the front 101 of the injector device 100. To adjust the depth of penetration of the syringe needle, the user grips the gripping surface 120 of the depth regulator 117 to rotate the depth regulator 117 clockwise or counterclockwise. Moving in one direction increases the depth of penetration of the needle by moving the depth regulator 117 backward relative to the regulator body 122. Moving in the other direction reduces the penetration depth of the needle by moving the depth adjuster 117 forward relative to the adjuster body 122.

The puller 125 of the casing is made with the possibility of installation on the front part 101 of the injection device 100 (Fig. 1). The housing puller 125 covers the grip surface 120 of the depth adjuster 117 when it is mounted on the front assembly 110 (see, for example, FIG. 8). The puller 125 of the casing is made with the possibility of fastening to the body 122 of the regulator, without being rotationally fixed on the regulator 117 depth. Rotational movement of the housing puller 125 does not cause rotational movement of the depth adjuster 117. Axial movement of the casing puller 125 also does not cause axial movement of the depth adjuster 117. Instead, axial movement of the housing puller 125 forward from the depth adjuster 117 removes the housing puller 125 from the regulator housing 122 (see, for example, FIG. 10). The casing puller 125 is configured to remove the casing covering the needle 185 of the syringe 180 (see FIG. 10). Thus, the syringe 180 can be installed in the front node 110 when the casing 186 covers the needle 185 (see Fig. 8). The housing puller 125 helps remove the housing 186 without exposing the user to contact with the needle 185.

As shown in FIG. 9, the housing puller 125 includes an outer wall 126 configured to snugly cover the outer portion of the depth adjuster 117. The external locking levers 127 extend in the rear direction from the outer wall 126 and are attached to the regulator body 122 (FIG. 9). The housing puller 125 also includes an inner wall 128 configured to fit snugly into the depth adjuster 117 and cover the needle shield 186 (see FIG. 9). The inner locking levers 129 extend in the rearward direction from the inner wall 128 to engage the edges of the needle shield 186. The housing puller 125 is removed from the front assembly 110 by applying traction to the housing puller 125 forward from the front assembly 110 with sufficient force to disengage the outer locking levers 127 (see FIG. 10). Internal locking levers 129 carry and carry the needle shield 186 when the shield puller 125 is retracted from the front assembly 110 (see FIG. 10).

As shown in FIG. 3, the rear assembly 130 includes an outer housing structure 131, an injection assembly 140, an inner housing 150, and a trigger mechanism 170. In some embodiments, the rear assembly 130 includes a deadlock structure 160 connecting the rear assembly 130 to the front assembly 110 (see, for example, FIG. 15). The interlocking structure 160 allows the injection device 100 to remain in a locked state (see FIGS. 13 and 15) in which the injection unit 140 cannot be activated, and an unlocked state (see FIGS. 14 and 16) in which the injection unit 140 can be activated, as will be shown in more detail below. In some embodiments, the rear assembly 130 includes an indicator assembly 175 (FIG. 3) that generates a completion indicator, as will be described in more detail below.

The inner housing 150 of the rear assembly 130 includes a hollow body 151 having an open end and a closed end (see FIGS. 12 and 17). The open end forms part of the interlock structure 160 (FIG. 12). The closed end is formed by the overlap structure 154, from which the structural protrusion 152 extends in the rear direction (FIG. 17). The structural protrusion 152 forms one or more rearward-facing shoulders located at a location spaced apart in the rear direction from the ceiling structure 154 (FIGS. 17 and 21). In one embodiment, the structural protrusion 152 includes two backward shoulders. The guide structure 153 extends in the rear direction from the structural protrusion 152 (FIGS. 12 and 17).

As further shown in FIG. 3, the injection assembly 140 includes a pusher 141, as well as a spring 149 with constant stiffness, biasing the pusher 141 towards the front of the injector device 100. At least a portion of the pusher 141 is placed in the inner housing 150 between the open end and the closed end. The pusher 141 is configured to move (eg, slide) in the inner housing 150 at least between the cocked position (FIG. 7) and the position to reach the bottom point (FIG. 5). Being in the cocked position, the pusher 141 is located at the closed end of the inner case 150. Being in the lowered position, the pusher 141 is located closer to the open end of the inner case 150. In some embodiments, the pusher 141 may be located in front of the inner case 150 while in the reaching position bottom point.

The pusher 141 forms a supporting surface 142 facing toward the front of 101 of the injector device 100 (FIG. 3). The abutment surface 142 is configured to engage and push the plunger 182 of the syringe 180 while moving in the direction of reaching the bottom point (see FIGS. 21 and 22). In one embodiment, the abutment surface 142 is flat (see FIG. 5). In some embodiments, the abutment surface 142 is spaced apart from the plunger 182 when the plunger 141 is in the cocked position (see FIGS. 15 and 16).

The pusher 141 also includes a locking lever 144 extending through an opening in the overlap structure 154 to the structural protrusion 152 (see FIG. 12). The locking lever 144 forms locking tabs 145 adapted to fit on the rearward facing shoulders of the structural protrusion 152 so as to detachably fasten the pusher 141 to the structural protrusion 152 in the cocked position (see, for example, FIG. 20). The tabs 145 of the locking lever 144 are configured to hold the pusher 141, counteracting the bias created by the spring 149 with constant stiffness, to keep the pusher 141 in the cocked position.

The pusher 141 also forms a spring support section 143 (FIG. 3) in an intermediate position between the support surface 142 and the locking lever 144. In some embodiments, a coil 148 (FIG. 3) is mounted in the spring support section 143, with the spring 149 having constant stiffness wound or otherwise fixed around coil 148 (see, for example, FIG. 12). The opposite end of the spring 149 is clamped, secured, or otherwise fixed between the inner housing 150 and the deadlock structure 160 (see FIG. 12).

The outer casing structure 131 includes a rear outer casing 132, in which the inner casing 150 is housed (see FIG. 3). Trigger structure 170 is mounted at the rear end of the rear outer housing 132 (see FIG. 3). In some embodiments, the trigger mechanism 170 includes a button 171 having forward-locking levers 172 (FIGS. 3 and 20) that snap or otherwise attach to the inner shoulders formed by the rear outer case 132 (see, for example, Fig. 7). Button 171 protrudes in the rearward direction from the rear outer housing 132 (see, for example, FIG. 7).

Button 171 is capable of moving relative to the rear outer housing 132 between the standby position (see, for example, FIG. 5) and the pressed position (see, for example, FIG. 12). Button 171 is located further in the rear outer case 132 when it is in the depressed position than when in the standby position. The trigger spring 174 biases the button 171 to its original position (see Fig. 5). The inclined structure 173 continues forward along the hollow interior of the button 171 (FIGS. 12 and 20). Moving the button 171 from the ready position to the pressed position, counteracting the offset created by the trigger spring 174, causes the inclined structure 173 to move forward relative to the rear outer housing 132.

In some embodiments, the indicator assembly 175 may be located between the inner housing 150 and the rear outer housing 132 (see FIGS. 3, 12, and 22). Indicator assembly 175 includes an indicator body 176 (FIG. 3). In some embodiments, the indicator body 176 includes a painted surface. In other embodiments, the indicator body 176 includes a surface on which signs are printed. In some embodiments, the indicator body 176 also includes a track-driven element 178 that extends radially inward from the body 176 to interact with the inner case body 151 (see FIGS. 21 and 22).

The indicator body 176 is slidable along the outer part of the inner body body 151 between the rear (i.e., locked) position (Fig. 21) and the front (i.e., displaced) position (Fig. 22). The diverting link (i.e., indicator spring) 179 biases the indicator body 176 in the forward position direction. In some embodiments, one or more of the tracks 156 or slots extend longitudinally along the circumferential wall of the hollow body 151 of the inner case 150 (FIG. 17). In some embodiments, the track-driven element 178 of the indicator body 176 extends into one of the tracks 156 and is slidable along it to prevent the rotational movement of the indicator body 176 (FIG. 12). In some embodiments, the track-driven element 178 may be used to reset the indicator link 176 in preparation for the injection unit 140, as will be shown in more detail below.

The indicator body 176 is held against the bias caused by the indicator spring 179 by means of latches 158 (FIGS. 17 and 20) provided on the inner case 150. The latches 158 are located on one or more flexible levers 157, extending in one or more slots in the floor body 151 (see FIG. 17). In some embodiments, leverage 157

- 6 029122 are configured to bend radially inward towards the interior of the hollow body 151. The locking links 158 extend outward from the flexible arms 157. The indicator spring 179 is powerful enough to push the indicator body 176 over the locking links 158, thereby pressing the locking links 158 into the slot in the direction of the inner space of the inner housing 150 (see Fig. 22). However, when the pusher 141 is placed in the cocked position in the inner case 150 (see, for example, FIG. 21), the pusher 141 prevents the locking links 158 from moving inward, as will be described in more detail below. Thus, the locking links 158 hold the indicator body 176, counteracting the bias created by the indicator spring 179 until the pusher 141 moves to an offset position.

The rear outer casing 132 forms at least one window opening 133 (FIG. 3) through which the indicator body 176 can be seen when the indicator body 176 is in the forward position (see, for example, FIG. 23). The indicator body 176 is visually inaccessible through the window opening 133 when the indicator body 176 is in the rear position (see, for example, FIG. 1). In one embodiment, the rear housing 132 forms a window opening 133 on only one of the side surfaces 103 of the housing 132. In another embodiment, the rear housing 132 forms a window opening 133 on both side surfaces 103 of the housing 132, with the indicator body 176 forming two indicator bodies 176 . In some embodiments, the window structure 134 (FIG. 3) may be stationary in the rear outer casing 132 in the window opening 133. The window structure 134 is made of a transparent or translucent material filling the opening 133 to protect the interior of the injector device 100.

The outer casing structure 131 also includes an intermediate outer casing 137 compatible with the rear outer casing 132 (see FIG. 3). The intermediate outer casing 137 forms a support structure 138 extending inward from the inner surface of the intermediate outer casing 137 (see FIG. 12). The support structure 138 forms a forward facing shoulder 139 (FIG. 12).

In some embodiments, one or both of the housings 132, 137 may include a gripping surface 135, 137, respectively, to aid in gripping the injector device 100 (see FIG. 1). In some embodiments, the gripping surfaces 135, 137 extend over at least a portion of the outer surfaces of the bodies 132, 137. In some embodiments, the gripping surfaces 135, 137 are made of compressible materials. In one embodiment, the gripping surfaces 135, 137 are made of rubber.

A deadlock structure 160 connects the front assembly 110 to the rear assembly 130 (see FIG. 15). The deadlock structure 160 includes a deadlock body 161 forming an internal thread 162 at the front end (FIGS. 3 and 12). The rear end of the interlocking body 161 is adapted to be attached to the inner case 150 (FIG. 12). The internal thread is adapted to engage with the external thread 163 located on the support 114 of the carrier (see FIG. 11) to releasably connect the rear assembly 130 to the front assembly 110.

In some embodiments, the internal thread and the external thread 163 are configured to facilitate quick threaded connection of the front and rear nodes 110, 130. For example, in some embodiments, both the internal thread 162 and the external thread 163 extend along the inner circumference of the corresponding node 110, 130 no more than two turns (see Fig. 11 and 12). In some embodiments, both the internal thread 162 and the external thread 163 extend along the inner circumference by more than one turn, but less than two turns. In some embodiments, both the internal thread 162 and the external thread 163 extend no more than one turn around the inner circumference of the corresponding assembly 110, 130. In some embodiments, both the internal and external threads 162, 163 extend by about half the inner circle corresponding node 110, 130.

As shown in FIG. 12, the inner housing 150 is detachably secured to the intermediate outer housing 137. The inner housing 150 forms a deadlock lever 155 extending forward from the stationary shoulder 164. The deadlock lever 155 includes a flexible arm configured to deflect inward relative to the rest of the inner housing 150 (see FIG. 15). The interlocking lever 155 includes a locking hook extending radially outward from the lever 155 to form a rearward-facing shoulder 159 (FIG. 12). The free end of the interlock lever 155 forms an inclined or contoured surface 169 that tapers or bends laterally across the lever 155 (see FIGS. 18 and 19).

When the rear outer casing 132 and the intermediate outer casing 137 are mounted on the inner casing 150, the support link 138 of the intermediate casing 137 is positioned between the fixed arm 164 of the inner casing 150 and the backward hook arm 159 of the locking hook (FIG. 12). Thus, the outer housing assembly 131 is held stationary relative to the inner housing 150 and the interlocking body 161. A portion of the interlocking body 161 (e.g., a strip) extends between the front assembly 110 and the rear assembly 130 (see FIG. 13).

- 7 029122

In FIG. 4-7 show how the injector device 100 is prepared for operation (i.e., how the plunger 141 (FIG. 3) moves from the low point to the cocked position). As shown in FIG. 4, the front assembly 110 is removed from the rear assembly 130 (for example, by unscrewing the carrier support 114 from the deadlock body 161). As shown in FIG. 5, the front assembly 110 is rotated 180 ° so that the casing puller 125 faces the rear assembly 130. As shown in FIG. 6 and 7, the front end of the front assembly 110 is inserted into the rear assembly 130 and slides in the rear direction in the inner housing 150.

The front end of the front assembly 110 engages with the pusher 141 and pushes the pusher 141 back into the inner housing 150 in the direction of the ceiling structure 154 (see FIG. 6). For example, in some embodiments, the casing puller 125 is pressed against the supporting surface 142 of the pusher 141. In other embodiments, the depth adjuster 117 is pressed against the supporting surface 142. The pusher 141 moves in the rear direction, counteracting the bias created by the spring 149 with constant stiffness. The overlap structure 154 prevents the plunger 141 from moving too far back. When the pusher 141 moves in the rear direction, the locking lever 144 extends beyond the overlap structure 154 in the direction of the structural protrusion 152 until the locking tabs 145 sit on the rear shoulders of the structural protrusion 152 in the cocked position (see FIG. 20).

In FIG. 8-11, the installation of the syringe 180 in the front assembly 110 is shown. The syringe 180 includes an ampoule 181 configured to hold a drug substance. The plunger 182 extends through the rear end of the ampoule 181 to a piston or plug 183 that hermetically seals the drug in the ampoule 181. The needle 185 (FIG. 10) is connected to the needle cannula 184 at the front end of the ampoule 181. A casing 186 surrounds the needle 185 (see, for example , Fig. 9). The casing 186 prevents the person manipulating the syringe from accidentally pricking with a needle 185.

As shown in FIG. 8, a syringe 180 is inserted into the rear end of the front assembly 110. The jacketed end of the syringe 180 is inserted through the syringe carrier 111 so that the support section 112 of the carrier 111 surrounds the ampoule section 181 (see, for example, FIGS. 9 and 10). A syringe 180 is inserted far enough into the front assembly 110, so that the needle shield 186 extends into the inner walls 128 of the shield puller 125. The locking levers 129 of the inner walls 128 engage or otherwise attach to the ends of the casing 186 (see Fig. 9).

As shown in FIG. 10, the housing puller 125 captures the housing 186 when the housing puller 125 is pulled forward of the front assembly 110, thereby removing the housing 186 from the needle 185. As shown in FIG. 11, the grip surface 120 of the depth adjuster 117 becomes accessible when the housing puller 125 is removed. The plunger 182 continues in the rearward direction of the ampoule 181 and the front assembly 110 when the syringe is mounted on the syringe carrier 111.

In FIG. 12 is a cross-sectional view of the rear assembly 130 after the injection assembly 140 is ready to operate, while the injection apparatus 100 is in a locked state. When in the locked state, the actuation of the trigger 170 will not start the injection unit 140. The pusher 141 is placed in the cocked position, while the locking tabs 145 of the pusher 141 are mounted on the structural protrusion 152 of the body 151 of the inner case. Spring 149 with constant rigidity is in tension.

The body 176 of the indicator is held in a fixed position, counteracting the bias created by the spring 179 of the indicator. In particular, the pusher 141 prevents bending inwardly of the flexible levers 157 of the inner housing 150, which allows the latches 158 (FIG. 18) to hold the indicator body 176. In addition, the shoulder 147 of the pusher 141 may engage with the track-driven member 178 to prevent the indicator body 176 from moving forward (FIG. 12). Shoulder 147 can also press on track-driven element 178 while alerting injection device 140 to reset indicator body 176 to the rear position (see, for example, FIGS. 5 and 7).

When the injector device 100 is in a locked state, the body 151 of the inner case is axially fixed relative to the outer case unit 131 (see FIG. 12). The fixed shoulder 164 of the body 151 of the inner case abuts against one end of the support link 138 of the intermediate outer case 137, thereby preventing the axial forward movement of the inner case 150 relative to the rear outer case 132. The locking hook (i.e., the backward facing arm 159) of the interlock lever 155 engages with a shoulder 139 at the opposite end of the support link 138, thereby preventing axial forward movement of the rear outer housing 132 relative to the inner housing 150 (FIG. 12). In addition, the trigger spring 174 biases the rear outer housing 132 to an extended position relative to the inner housing 150 (FIG. 12). For example, one end of the spring 179 is fitted to the overlap structure 154 of the inner housing 150, and the opposite end of the spring 179 puts pressure on the inside of the button 171 (see FIG. 12).

As shown in FIG. 12, pressing the start button 171 when the rear outer casing 132 is placed in the extended position does not actuate the injection unit 140. Pressing the start button 171 into the rear outer casing 132 causes the tilted structure 173 on the inner part of the button 171 moves forward toward the protruding structure 152 of the inner housing 150. However, even when the button 171 is fully depressed, the tilted structure 173 does not reach the locking tabs 145 of the pusher locking lever 144. Thus, the inclined button structure 173 cannot release the locking lever 144 from the protruding structure 152 to actuate the injection unit 140.

In FIG. 13-19 show how an injector device 100 transitions from a locked state to an unlocked state.

As shown in FIG. 13, the front assembly 110 is attached to the rear assembly 130 so that the strip of the interlocking body 161 is visible between the carrier support 114 and the intermediate outer casing 137. The first alignment indicator 165 of the front assembly 110 is aligned with the second alignment indicator 166 of the rear assembly 130. For example, the front assembly 110 can be screwed into the rear assembly 130 until the first and second alignment indicators 165, 166 are facing each other, indicating a rotational alignment of the front and rear assemblies 110, 130. As shown in FIG. 14, when the front and rear nodes 110, 130 are rotationally aligned, the rear node 130 can be axially moved forward in the direction of the front node 110, so that the intermediate outer casing 137 covers a deadlock body 161 that is within sight (compare Figs. 13 and 14 )

In FIG. 15 and 16 are axial sectional views of an injector device 100 illustrating a transition from a locked state to an unlocked state. In the locked state, the axial clearance between the protruding structure 152 of the inner case 150 and the rear end 102 of the rear outer case 132 is sufficient to keep the inclined structure 173 of the start button 171 disconnected from the locking tabs 145 of the pusher 141 even when the start button 171 is pressed (see, for example, FIG. . fifteen). Thus, pressing the start button 171 when the injection device 100 is in a locked state does not actuate the injection unit 140.

Since the locking lever 155 is unlocked (i.e., bent inward), the rear outer housing 132 can move relative to the inner housing 150 and the front assembly 110 to the forward, retracted position, counteracting the bias created by the trigger spring 174. The rear outer housing 132 is moved to covering the interlocking body 161, so that the interlocking body 161 is no longer in the visibility of the user. As shown in FIG. 16, sliding the rear outer housing 132 into the retracted position brings the start button 171 closer to the protruding structure 152 and the push tabs 145. Pressing the start button 171 of the injector device 100, now unlocked, moves the inclined structure 173 into engagement with the locking tabs 145 of the pusher locking lever 144.

In FIG. 17-19 show how the interlock structure 160 enables the injector device 100 to transition from a locked state to an unlocked state. As shown in FIG. 17, the front assembly 110 includes one or more rearward extending legs 167 (e.g., located at the rear of the carrier support 114). As shown in FIG. 19, the backward extending foot 167 forms an inclined or otherwise contoured surface 168 configured to interact with an inclined or otherwise contoured surface 169 at the free end of the interlock lever 155 of the inner case 150. For example, the foot 167 may extend onto the locking surface 169a of the contoured surface 169. In some embodiments, the foot 167 makes an audible sound (for example, a click) when the foot 167 enters the locking surface 169a.

When the front assembly 110 is threaded to the rear assembly 130, the rearwardly extending tab 167 of the front assembly 110 engages with the free end of the interlock lever 155 to deflect the interlock lever 155 radially inward, as shown in FIG. 15. The bending of the interlocking lever 155 inward moves the locking hook (and hence the backward facing arm 159) of the interlocking lever 155 from the support member 138 of the inner case 150 (see FIG. 15). The rear outer housing assembly 132 can move forward relative to the interlocking body 161 while the interlocking lever 155 is held inwardly curved (see FIG. 16).

In some embodiments, the interlocking assembly 160 includes a locking spring 189 (FIG. 3) biasing the interlocking arm 155 radially outward in the locked position. In some embodiments, the implementation of the locking spring 189 provides support for the interlock lever 155 to prevent the destruction of the lever 155 after repeated use. In such embodiments, the interlocking lever 155 is mainly biased towards the locking position due to the elasticity and resilience of the material of the interlocking lever 155. In other embodiments, the locking spring 189 operates to maintain the interlocking lever 155 in the locked position.

In FIG. 16 and 20-22, the actuation of the injection unit 140 of the injection device 100 is shown. As shown in FIG. 16, the injector device 100 is in an unlocked state to initiate an injection. The carrier spring 116 biases the syringe carrier 111 in the rear direction so that the needle 185 is located in the depth adjuster 117. The syringe plunger 182 continues 9,029,122 in the rear direction to the plunger 141, which is in the cocked position. In some embodiments, the support surface 142 of the plunger 141 is axially spaced from the syringe plunger 182. In other embodiments, the pusher 141 abuts against the syringe plunger 182. The start button 171 is within reach of the locking tabs 145 of the pusher locking lever 144.

As shown in FIG. 20, pressing the start button 171 in the depressing direction приводит causes the inclined structure 173 to push the locking tabs 145 of the pusher locking lever 144 in the bend direction P from the protruding structure 152 of the inner case 150. In some embodiments, the protruding structure 152 is contoured so that the movement the locking tabs 145 in the lateral bending direction P causes the pusher 141 to move in the rear direction, counteracting the bias created by the spring 149 with constant stiffness, while the locking tabs 145 will not release the protruding structure 152 (see FIG. 20). When the locking tabs 145 release the protruding structure 152, the plunger 141 is no longer held, counteracting the bias created by the spring 149 with constant stiffness.

As shown in FIG. 21, a spring 149 with constant stiffness pulls the pusher 141 forward in the displaced position direction when the pusher 141 is no longer held in the cocked position. When the plunger 141 moves forward, the abutment surface 142 of the plunger 141 engages with the syringe plunger 182. However, the plunger 141 does not immediately move the plunger 182 in the ampoule 181. Instead, since the compression resistance of the carrier spring 116 is sufficiently small, the carrier spring 116 begins to compress before the plunger 182 begins to move in the ampoule 181. As the carrier spring 116 is compressed, the carrier 111 the syringe moves forward relative to the support 114 of the carrier until the sleeve 113 of the carrier 111 of the syringe engages with the front wall of the support 114 of the carrier (for example, will engage with the first damper 192). The syringe carrier 111 carries the syringe 180 forward, thereby introducing the needle 185 into the injection site.

As shown in FIG. 22, the pusher 141 presses the plunger 182 in the ampoule 181 to dispense the drug substance. When the syringe carrier 111 reaches a low point (i.e., engages with the front wall), the feed force of the plunger 141 is sufficient to overcome the resistance of the plunger 182. Since the plunger spring 149 is a spring with constant stiffness, drug is dispensed from the syringe 180 at a more constant speed than with a coil spring. After the drug is dispensed, the pusher spring 149 continues to exert forward pressure on the syringe plunger 182. Thus, the needle of the syringe 185 continues to protrude from the front end 101 of the injection device 100, even after the injection device 100 is removed from the injection site.

As shown in FIG. 16, 21, and 22, the instant completion indicator 175 is automatically activated by the injection unit 140. As shown in FIG. 16, the indicator body 176 is in a rear position, counteracting the bias created by the indicator spring 179 before the start button 171 is actuated. While in the cocked position, the pusher 141 prevents bending inside the levers 157 of the inner housing 150. Thus, the locking links 158 (Fig. 20) hold the indicator body 176, counteracting the bias created by the spring 179. In addition, the shoulder 147 of the pusher 141 is engaged track-driven element 178 of indicator body 176 (FIG. 16). As shown in FIG. 21, the indicator body 176 is still held in the rear position as the pusher 141 continues along the portion of the flexible arms 157.

As shown in FIG. 22, the indicator body 176 moves over the locking links 158 when the pusher 141 moves far enough forward in the inner housing 150 to release the flexible arms 157 to allow movement of the locking links 158 inward. In the illustrated example, the pusher 141 releases the flexible arms 157 when the piston 183 reaches the lowest point in the ampoule of the 181 syringe. In other embodiments, the plunger 141 releases the flexible arms 157 when the plunger 182 has moved far enough forward to dispense a dose of drug from the syringe 180 (for example, even if the piston 183 has not fully reached the bottom point).

The indicator spring 179 pushes the indicator body 176 forward along the inner case 150. As the case 176 slides forward, the track-driven element 178 slides in the longitudinal track 156 formed in the side wall of the body 151 of the inner case. The tracked member 178 prevents the indicator link 176 from rotating when the indicator link 176 moves forward. Thus, the track-driven element 178 does not allow the indicator body 176 to leave the position of the circumferential alignment with the window 134 (Fig. 1).

As shown in FIG. 22, indicator body 176 is radially aligned with window 134 when dispensing a drug. As shown in FIG. 1, the inner body body 151 can be seen through the window 134 before the indicator body 176 is aligned with the window 134. As shown in FIG. 22, indicator body 176 can be seen through window 124 when delivery is complete. In some embodiments, the indicator body 176 has a different color (e.g., red) than the body 151 of the inner case (e.g., white). Thus, an instant color change in window 134 indicates the completion of the injection process.

- 10 029122

As noted above, the expression at completion may refer to a time frame including the time of completion, the time immediately after the time of completion, or the time within a few milliseconds before and after completion (for example, due to permissible deviations in the operation of the injector device). If many events occur at completion, events can occur simultaneously, immediately one after another or within a few milliseconds relative to each other. In some embodiments, the track-driven element 178 makes an audible sound (eg, a click) when the track-driven element 178 is engaged with the shoulder 177 of the inner case 150 when the body 176 reaches the forward position indicator (see FIG. 22). Thus, in some embodiments, the instant completion indicator 175 emits an audible sound to signal the completion of the dispensing step.

In some embodiments, the indicator spring 179 is powerful enough so that the indicator body 176 instantly fills the window 134. For example, the indicator spring 179 can move the indicator body 176 forward so quickly that the user cannot track the front end of the indicator body 176 along the window 134. In some embodiments, the movement of the indicator body 176 relative to the window 134 is not tied to the movement (i.e., isolated from movement) of the plunger 182 in the syringe ampoule 181. For example, being released from the flexible levers 157, the indicator body 176 is moved forward by the indicator spring 179 regardless of the position of the pusher 141 in the body 151 of the inner case.

The above-described injector device 100 is intended for use with a syringe containing an injectable fluid. An example of a fluid suitable for filling a syringe is Glatiramer acetate. Glatiramer acetate (SL), also known as copolymer-1, has been shown to be effective in the treatment of multiple sclerosis (M8) (Lattreg1, 1978). Daily injections of glatiramer acetate (20 mg per injection) reduces the frequency of relapses, the development of dysfunctions, the appearance of new foci detected by magnetic resonance imaging (MK1) (October 8, 1995), as well as the appearance of black holes (ίρρί, 2001).

ΟΟΡΑΧΟΝΕ® is a trademark of a composition containing glatiramer acetate as an active ingredient. Glatiramer acetate is approved to reduce the recurrence rate in relapsing-remitting remitting multiple sclerosis (CMC8). Glatiramer acetate consists of acetate salts of synthetic polypeptides containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine and L-lysine, the average molar fractions of which in the L® preparation are 0.141, 0.427, 0.095 and 0.338, respectively. In ΟΟΡΑΧΟΝΕ®, the average molecular weight of glatiramer acetate is 4700–11000 Da. Chemically, glatiramer acetate is defined as the acetate (salt) of the L-glutamic acid polymer with L-alanine, L-lysine and L-tyrosine. Its structural formula is:

(C1i, A1a, L5, T \ r). LS117ΌΟΙI (Ο ₅ Η ₉ ΝΟ ₄ ΑΟ3Η ₇ ΝΟ ₂ ΑΟ ₆ Η ₁₄ Ν ₂ Ο ₂ ΑΟ ₉ Η ₁₁ ΝΟ ₃ ) _ρ ΑΡΟ ₂ Η ₄ Ο ₂

CA8 - 147245-92-9.

The recommended dosage regimen for СΟΡXΟNΕ® in case of recurrent remitting multiple sclerosis is 20 mg per day, it is administered subcutaneously (Doctor's Handbook (Рёу81С1аи'8 Эе ^ к КеГетеисе)). Further information on dosage regimens can also be found in US Pat. Nos. 3,849,550; 5,800,808; 5858964, 5981589; 6,048,898; 6054430; 6,214,791; 6342476; and 6,362,161, the disclosures of which are incorporated herein by reference.

Although the mechanism of action has not been fully identified, it is assumed that CΑ binds and is displayed as an antigen in the groove of the molecule of the main histocompatibility complex (MHC). As an alternative, it is assumed that CΑ is absorbed by antigen-presenting cells (APC), after which fragments are presented. In any case, the presence of CΑ leads to the formation of CΑ-specific T cells. Although the mechanisms are still not clear, the CΑ-specific T cells are mainly biased T-helper 2 (TB2). Tb2 cells produce Tb2 cytokines that inhibit the production of cytokines by Tb1 cells or macrophages and exhibit anti-inflammatory properties. Unlike interferon-β, which obviously acts on the blood-brain barrier (BBB) and disrupts the migration of inflammatory cells in the central nervous system, the effect of CΑ on BBB is negligible, which allows CΑ-specific TB2 lymphocytes to penetrate the central nervous system to reduce inflammation by suppressing immune response by an unrelated antigen (Wold. 2002).

Some aspects of the injector device include:

(a) a first housing unit configured to hold a syringe;

(b) a second housing unit including an outer case and an inner case;

(c) a locking member rigidly holding the outer housing in an extended position; and also (s) a deadlock assembly configured to rotatably attach the first housing assembly to the second housing assembly in a certain rotational position.

The inner housing is axially fixed relative to the first housing assembly. The outer housing is axially movable relative to the first housing assembly between the extended position and the retracted position. The second housing unit includes an injection unit configured to control the syringe to administer the drug from the syringe. The second housing unit includes a trigger link configured to start the injection unit only when the outer housing is in the retracted position. The second housing unit includes a deflector link biasing the outer housing to an extended position. The interlocking unit is also configured to unlock the locking link when the first and second housing units are in a certain pivoting position. The outer housing is able to move relative to the first housing assembly in a retracted position, counteracting the bias created by the deflecting link when the locking link is unlocked.

In some embodiments, the first housing unit includes a first alignment indicator, wherein the outer housing of the second housing unit includes a second alignment indicator, wherein the first and second alignment indicators are aligned when the first and second housing units are oriented in a certain pivoting position.

In some embodiments, the interlocking assembly includes a interlocking strip that is visually accessible between the first housing assembly and the second housing assembly when the outer housing is in an extended position, while the interlocking strip is not visible when the outer housing is in the retracted position.

In some embodiments, the locking member includes a flexible locking hook located on the inner housing, wherein the locking hook is adapted to engage with a shoulder located on the inside of the outer housing, wherein the interlocking assembly includes a tab bending the locking hook from the shoulder when the first and second housing units are oriented in a certain pivoting position.

In some embodiments, the trigger link includes a button mounted on the outer housing and configured to move between the ready position and the pressed position. The button is spaced far enough away from the injection unit when the outer case is placed in the extended position to prevent the button from starting the injection unit even when pressed. Moving the outer casing to a retracted position moves the button close enough to the injection unit to allow the injection unit to start when the button moves to the pressed position.

In some embodiments, the injection unit includes a pusher as well as a spring biasing the pusher in the direction of the syringe. The pusher includes a flexible locking lever, which engages with a shoulder formed by the inner housing for holding the pusher, counteracting the bias created by the spring. Moving the button close enough to the injection unit includes moving the button within range of the flexible closure, so moving the button to the pressed position releases the flexible closure from the shoulder to release the push rod.

In some embodiments, the deflection link biases the outer case toward the extended position by pushing the button away from the inner case toward the ready position.

In some embodiments, the outer casing is moved relative to the first casing assembly when the first casing assembly is pressed against the injection site, with the user gripping the outer casing and pushing the outer casing toward the injection section.

In some embodiments, the syringe comprises a composition comprising glatiramer acetate. In one embodiment, the composition comprises 20 mg of glatiramer acetate per ml of composition. In one embodiment, the composition includes 40 mg of glatiramer acetate per ml of composition.

In some embodiments, the syringe includes a needle configured to extend from the first case assembly during the dispensing step, wherein the first case assembly includes a depth adjuster that changes the length of the needle segment extending from the first case assembly.

In some embodiments, the depth regulator is capable of moving between discrete stop positions, with each discrete stop position corresponding to a different depth of needle insertion, so moving the depth regulator to one of the discrete stop positions sets the corresponding penetration depth of the needle.

In some embodiments, the needle shield puller is mounted on a depth adjuster. The needle shield puller is configured to be connected to a depth adjuster so that the depth adjuster remains axially and rotationally stationary during any movement of the needle shield puller.

In some embodiments, numbers are displayed on the depth adjuster to indicate the depth of penetration of the needle, with the displayed numbers having a size of at least 4 mm.

- 12 029122

In some embodiments, the second housing unit includes a compressible gripping surface extending over a portion of the outer portion of the second housing assembly.

In some embodiments, both the first and second housing units include a threaded portion that is attached to another threaded portion to connect the first and second housing units.

In some embodiments, each of the threaded portions includes a thread that extends no more than the inner circumference of the corresponding housing unit.

In some embodiments, the thread of each threaded portion extends about half the inner circumference of the corresponding body assembly.

In some embodiments, the first housing unit includes a first foot and the second housing unit forms a locking surface, wherein the first foot comes on the locking surface when the first and second housing units are interconnected by thread, while the first foot makes an audible sound, when the first foot comes on the locking surface.

In some embodiments, a link for indicating instant completion is located in the interior of the outer case. The link indicating the instantaneous completion is arranged to move relative to the outer casing between the first position and the second position. The link for indicating instant completion is visually inaccessible through the window formed in the outer casing, being in the first position, while it can be seen through the window when in the second position, while the movement of the link for indicating instant completion from the first position to the second position is initiated when the issuing stage is completed .

In some embodiments, a color change can be seen through a window as the instant completion link moves from a first position to a second position.

In some embodiments, the injector device makes an audible sound when the delivery step is completed.

In some embodiments, the instant completion link is biased toward the second position by the deflecting link; wherein the injection unit includes at least one stop link that holds the instant completion link, counteracting the bias created by the deflecting link, while the stop link automatically unlocks the display link at the end of the dispensing step.

The above description, examples and informational data give a complete picture of the production aspects and use of the invention. Since many embodiments of the invention can be implemented without going beyond the essence and scope of the invention, the invention is defined by the appended claims.

References

1. LattregE, AeEo1ttype apD νίπΐΞ-ίηάυοθά 0ueePaE1pd sNeasez. Α ΓβνίθΜ, At. L. RaE., 1978, 91: 176-208.

. 2. Lopzop eE a1 Soro1uteg 1 gedisez ge1arze gaEe ADF ίπιρΓονθ5 sIzaYShu ίη ge1arz1pd-get1EE1pd ti1E1r1e zs1egoz1z: gezi1Ez of £ and raze III tiShsep er, 1oiYe-Pp1 r1aseosop go11e1 Eg1a1!. Thier Sorocilum 1 Mucilpensis sulcensis Zeitsu bgoir, Leigo1., 1995, 45: 1268.

3. Είΐίρρί Е 1 а. Ат. 61 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1,,,,,. Иг иг иг иг иг иг иг иг иг иг иг иг иг иг.

2001, 57: 731-733.

4. ΟΟΡΑΧΟΝΕ® ίη уз 1 1 1 с с О О О ез Не Е Е,,,,, от р р р Не Не Е Е Е Е 1 1 1 1 1 п п п п, 2008,

3110-3113.

5. Wopd (2002) O1 £ еп еп Е Е а а те ск ск ас ас ас Е Е Е Е Е о о о £ £

1 Е £ оп оп----ап Д д М М ат ат ат ег ег ег М М М М М иг иг иг иг. 59: 1-7.

- 13 029122

Claims (24)

CLAIM 1. Injection device containing: (a) a first housing unit configured to hold a syringe; (b) a second housing unit including an outer housing and an inner housing, wherein the inner housing is axially fixed relative to the first housing assembly, and the outer housing is movable axially relative to the first housing assembly between the extended position and the retracted position, an injection unit configured to control a syringe for administering a drug substance from a syringe; a trigger unit configured to start an injection unit then ko when the outer housing in a retracted position and the deflecting member, biasing the outer housing to an extended position; (c) a locking member rigidly holding the outer housing in an extended position; and (ά) a deadlock assembly made with the possibility of pivoting the first housing assembly to the second housing assembly in a certain rotational position and unlocking the locking link when the first and second housing assemblies are in a certain rotational position, while the outer housing is able to move relative to the first housing assembly to the retracted position, counteracting the bias created by the deflecting link when the locking link is unlocked. 2. The injection device according to claim 1, wherein the first housing unit includes a first alignment indicator, and the outer housing of the second housing unit includes a second alignment indicator, while the first and second alignment indicators can be combined when the first and second housing units oriented in a certain rotary position. 3. The injector device according to claim 1, wherein the interlocking unit includes a interlocking strip that is visually accessible between the first case unit and the second case unit when the outer case is placed in the extended position, while the interlocking strip is not visible when the outer case is in laid back position. 4. The injector device according to claim 1, wherein the locking link includes a flexible locking hook located on the inner housing, the locking hook is configured to engage with a shoulder located on the inner part of the outer housing, while the interlocking unit includes in the foot, bending the locking hook from the shoulder, when the first and second housing units are oriented in a certain rotary position. 5. The injection device according to claim 4, wherein the trigger link includes a button mounted on the outer case and configured to move between the ready position and the pressed position, the button being spaced far enough from the injection unit when the outer case is placed in the extended position to prevent the button from starting the injection unit even when pressed, while moving the outer case to the backward position can move the button close enough to the injection at the site to provide the ability to run the injection site when you move the button in the depressed position. 6. The injector device according to claim 5, wherein the injection unit includes a pusher, as well as a spring biasing the pusher in the direction of the syringe, the pusher includes a flexible locking lever that engages with a shoulder formed by the inner housing for holding the pusher, counteracting the displacement caused by the spring, while moving the button close enough to the injection unit includes moving the button within reach of the flexible lock, so moving the button to the pressed position can can release flexible constipation from the shoulder to release the push rod. 7. The injection device according to claim 6, wherein the deflector can bias the outer casing in the direction of the extended position by shifting the button from the inner casing in the direction of the ready position. 8. The injector device according to claim 4, wherein the outer case can move relative to the first case unit when the first case unit is pressed against the injection site, while the user can grab the outer case and push the outer case toward the injection site. 9. The injector device according to claim 1, wherein the syringe contains a composition comprising glatiramer acetate. 10. The injector device according to claim 9, wherein the composition is 1 ml of a composition containing 20 mg of glatiramer acetate. 11. The injector device according to claim 9, wherein the composition is 1 ml of a composition containing 40 mg of glatiramer acetate. 12. The injector device according to claim 1, wherein the syringe includes a needle made with the possibility of continuation from the first body unit during the dispensing step, wherein the first body unit includes a depth regulator that changes the length of the needle segment, continuing from the first housing unit. 13. The injector device according to claim 12, wherein the depth regulator is capable of moving between discrete stop positions, wherein each discrete stop position corresponds to a different depth of needle insertion, so that moving the depth regulator to one of the discrete stop positions can set the corresponding penetration depth of the needle. 14. The injection device according to item 12, further comprising a needle shield puller that is mounted on the depth adjuster, wherein the needle shield puller is configured to connect to the first housing unit so that the depth adjuster can remain axially and rotationally stationary during any movement of the puller needle shield. 15. The injection device according to item 12, while the numbers on the depth adjuster are displayed to indicate the depth of penetration of the needle, while the displayed numbers have a size of at least 4 mm. 16. The injector device according to claim 1, wherein the second housing unit includes a compressible gripping surface extending over a portion of the outer part of the second housing unit. 17. The injection device according to claim 1, wherein both the first and second housing units include a threaded portion for connecting the first and second housing units. 18. The injector device according to claim 17, wherein each of the threaded portions includes a thread that extends no more than the inner circumference of the corresponding housing unit. 19. The injector device according to claim 18, wherein the thread of each threaded portion is continued along approximately half the inner circumference of the corresponding housing unit. 20. The injector device according to claim 18, wherein the first housing unit includes a first foot and the second housing unit forms a locking surface, while the first foot comes onto the locking surface when the first and second housing units are connected by thread, This first foot can make an audible sound when it comes to the locking surface. 21. The injection device according to claim 1, further comprising an instant completion indication link located in the inner space of the outer case, wherein the instant completion indication link is movable relative to the outer case between the first position and the second position and is visually inaccessible through the window formed in the outer case, being in the first position, while it can be seen through the window when in the second position, while moving the display link instant End a of the first position to the second position can be initiated on completion of the dispensing. 22. The injection device according to item 21, while through the window you can see the color change when you move the link indicating the instantaneous completion from the first position to the second position. 23. The injection device according to item 21, while the injection device can make an audible sound at the end of the stage issuance. 24. The injection device according to item 21, while the link indicating the instantaneous completion can be displaced in the direction of the second position by the deflecting link; wherein the injection unit includes at least one stop link that can hold the instant completion link, counteracting the bias created by the deflecting link, while the stop link can automatically unlock the display link at the end of the dispensing step. 101 470