JP6073507B2 - Reusable injector device for syringe - Google Patents

Description

  The drug can be delivered from a syringe by using an injector device. Some injector devices have springs in a compressed state such that only a trigger actuation by the user is required for drug delivery. Certain types of injector devices also automatically insert a needle into the injection site prior to drug delivery. For example, certain types of injector devices trigger operation when the front of the injector device is pressed against the injection site. A particular type of injector device is a “one-shot” device. Other types of injector devices are configured to be reused by allowing replacement of a used syringe with a replacement syringe. Certain types of syringe devices include an indicator that provides notification of the number of times the syringe device has infused medication and the amount of medication delivered.

  According to some aspects of the present disclosure, an injector device includes a first housing assembly configured to hold a syringe, a second housing assembly, a locking member, and a first in a particular rotational position. An interlock assembly configured to rotatably mount the housing assembly to the second housing assembly. The second housing assembly includes an outer housing and an inner housing. The inner housing is configured to be fixed in the axial direction relative to the first housing assembly. The outer housing is configured to move axially in relation to the first housing assembly between the extended position and the retracted position. The second housing assembly includes an infusion assembly configured to operate the syringe to infuse medication from the syringe. The second housing assembly includes a trigger member configured to fire the injection assembly only when the outer housing is in the retracted position. The second housing assembly includes a biasing member that biases the outer housing to the extended position. The locking member holds the outer housing in a fixed state in the extended position. The interlock assembly is configured to release the locking member such that the outer housing can move to a retracted position relative to the first housing assembly in pressure contact with the biasing of the biasing member. Yes.

  In accordance with other aspects of the present disclosure, an injector device is disposed within an injector body including an injector body including a front assembly and a rear assembly that cooperate to define an interior, a syringe, and an injector body. An injection assembly. The front assembly includes a front housing, a syringe carrier that is portable in relation to the front housing between a rear position and a front position, a first damper disposed behind the front housing, and a syringe carrier A second damper disposed behind the body. The syringe carrier is engaged with the first damper when in the forward position, and the syringe carrier is spaced from the first damper when in the rear position. The syringe is configured to be coupled to a syringe carrier for movement together. The syringe includes an ampoule, a needle, and a plunger. The needle extends from the first end of the ampoule and the plunger extends 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 retain a common volume of any one of the at least two different drug formulations without any changes to the injector device. The first drug formulation of the two different drug formulations has a first viscosity, and the second drug formulation of the two different drug formulations has a second viscosity different from the first viscosity . The infusion assembly is configured to deliver a drug prescription held by a syringe. The injection assembly includes a ram that is driven by a constant force spring. By releasing the constant force spring, the syringe carrier drives the syringe carrier from the rear position to the front position until it is engaged with the first damper. The constant force spring drives the plunger within the ampule of the syringe after the syringe carrier is in the forward position. The first and second dampers prevent ampoule breakage during syringe carrier movement and plunger movement.

  In accordance with certain aspects of the present disclosure, the injector device includes a burst completion indicator member disposed within the injector body. The burst completion indicator member is configured to move in relation to the injector body between a first position and a second position. The burst completion indicator member is not visible through the window in the injector body when in the first position, and is visible through the window when in the second position. Movement of the sudden completion indicator member from the first position to the second position can be activated upon completion of the dispensing step.

  In the following description, various additional inventive aspects will be described. These inventive aspects may relate to individual features and combinations of features. Both the foregoing general description and the following detailed description are for purposes of illustration and description only and represent a broad inventive concept upon which the embodiments disclosed herein may be relied upon. It should be understood that this is not a limitation.

  The accompanying drawings, which are incorporated in and constitute a part of this description, illustrate several aspects of the present disclosure. A brief description of the drawings is as follows.

1 is a front perspective view of an exemplary injector device constructed in accordance with the principles of the present disclosure. FIG. 2 is a front perspective view of the injector device of FIG. 1 with the sheath remover removed from the injector device. FIG. FIG. 2 is an exploded view of the injector device of FIG. 1. 2 is a side view of the injector device of FIG. 1 with the front assembly axially separated from the rear assembly. FIG. FIG. 5 is an axial cross-sectional view of the injector device of FIG. 4 with the front assembly inverted so as to face the rear assembly. FIG. 5 is a side view of the injector device of FIG. 4 with the front end of the front assembly inserted into the front end of the rear assembly to enable the injection system of the injector device. FIG. 7 is an axial cross-sectional view of the injector device of FIG. 2 is an axial cross-section of the front assembly of the injector device of FIG. 1 with the syringe loaded in the front assembly. 2 is an enlarged cross-sectional view of the front end of the injector device of FIG. 1 with the syringe loaded so that the sheath remover of the front assembly engages the needle sheath. FIG. 10 shows the sheath remover and needle removed from the injector device of FIG. FIG. 11 is a side view of the front assembly of FIG. 10 with a syringe loaded therein and a sheath remover removed. FIG. 5 is a perspective view of the rear assembly shown in FIG. 4 in an axial cross-section and isolated from the front assembly. 2 is a side view of the injector device of FIG. 1 with the rear housing disposed in an extended position. FIG. FIG. 14 is a side view of the injector device of FIG. 13 with the rear housing disposed in the retracted position. FIG. 14 is an axial cross-sectional view of the injector device of FIG. 13. FIG. 15 is an axial cross-sectional view of the injector device of FIG. Of the inner housing of the rear assembly positioned in relation to the front assembly shown in isolation from the outer housing of the rear assembly so that the interlock arm and the rearward extending tab are visible. It is a perspective view. FIG. 18 is an enlarged perspective view of a part of FIG. 17. FIG. 17 is a rear perspective view of the front assembly of FIG. 16 with the cross-section of the interlock arm visible. FIG. 6 is a perspective view of a trigger button disposed around the inner housing edge structure. FIG. 17 is an axial cross-sectional view of the injector device of FIG. 16 with the trigger button depressed, the ram of the injection assembly released from the firing preparation position, and the syringe carrier bottomed out. FIG. 22 is an axial cross-sectional view of the injector device of FIG. 21 with the plunger bottomed out in the syringe and the burst completion indicator disposed in the forward position. FIG. 3 is a perspective view of the injector device of FIG. 2 with a syringe needle protruding from the front of the injector device and a completion indicator disposed in the forward position.

  Reference will now be made in detail to the exemplary aspects of the disclosure, which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

  In general, the present disclosure is directed to an injector device configured to hold a syringe and an injection assembly. The infusion assembly is configured to deliver the drug from the syringe (ie, release fluid from the syringe) in the dispensing step. In some implementations, the infusion assembly also moves the syringe from the retracted position to the extended position to inject the syringe during the infusion step (ie, insert a needle at the infusion site). Also) is configured. In certain implementations, the injector device is reusable. For example, the syringe may be removed after use and replaced with a new syringe.

  In some implementations, the injector has a completion indicator that informs that the medication delivery is complete and the user can retract the needle from the injection site. In certain implementations, the completion indicator is a sudden completion indicator. For example, the completion indicator is only activated upon completion of the delivery step. As used herein, the term “on completion” refers to the moment of completion, the time immediately following the moment of completion, and the time within a few milliseconds before and after completion (eg, due to tolerances within the injector device). Means a time frame that includes The indication provided by the sudden completion indicator does not change until the supply is complete. In some implementations, the abrupt completion indicator includes a window in which a color change becomes visible when delivery is complete. In certain implementations, the sudden completion indicator includes audible sound that is generated when delivery is complete. In certain implementations, the sudden completion indicator includes both a color change and an audible sound.

  According to some implementations, the injector device is configured for use with a syringe that may have any one of at least two different formulations. The prescription used in the syringe may be switched between the two prescriptions without any adjustment to the injector device. For example, the injector device may be used with a first syringe having 20 milligrams of a particular drug in a particular volume. The first syringe may be replaced with a second syringe containing 40 milligrams of drug in the same volume after infusion. The injector device may inject and deliver the second syringe without any adjustments made to the injector device.

  The same injector device can accept the first or second syringe. For example, the dimensions of the first syringe and the second syringe may be substantially the same. There is no need to resize, move, or otherwise change parts of the injector device to switch the prescription loaded. For both syringes, for example, the same constant force spring, the same ram arrangement, and the same plunger depth may be used. Thus, prior to each infusion, the user can select whether the infusion device is loaded with a first formulation or a second formulation. The syringe carrier and the damping area on the carrier holder prevent the syringe from being destroyed during injection and delivery. For example, the damping area may be a failure of the syringe during injection (e.g., cracking, crushing and / or crushing an ampoule, deformation or displacement of the needle hub in relation to the ampoule, or a syringe that does not include a damping area, or The rate or frequency of other damage to the syringe) may be reduced.

  According to some implementations, the injector device can be configured until the injector device is properly assembled, pressed against the injection site with a predetermined amount of force, and the trigger is activated. Includes safety features that prevent fire. For example, pressing a trigger button on the injector device when a predetermined amount of force is not being applied to the injector device will not inject the syringe or actuate the injection assembly to deliver the drug. Let's go. In some implementations, the injector device includes a front assembly and a rear assembly that are rotationally aligned and move axially toward each other before the injection assembly is fired upon actuation of a trigger. including.

  1 and 2 show an exemplary injector device 100 extending between the front portion 101 and the rear portion 102. The injector device 100 has an opposite side surface 103 that extends between a front portion 101 and a rear portion 102. In general, the injector device 100 is configured to deliver a drug from the front portion 101 when triggered at the rear portion 102. The injector device 100 also has an opposite end surface 104 that extends between the side surfaces 103 and between the front portion 101 and the rear portion 102. In some implementations, the side surface 103 has a larger cross-sectional dimension than the end surface 104.

  Injector device 100 includes a front assembly 110 and a rear assembly 130 that are coupled together. The front assembly 110 is configured to hold a syringe 180 (FIG. 8). The rear assembly 130 is configured to hold the infusion assembly 140 (FIG. 12). In some implementations, the front and rear assemblies 110, 130 can be removably coupled together to provide access to the interior of the injector device 100. For example, the front assembly 110 may be screwed onto the rear assembly 130, may be latched, may be snap fitted, may be friction fitted, or otherwise releasable. May be combined. By releasing the front assembly 110 from the rear assembly 130, the user can replace the syringe in the front assembly 110.

  As shown in FIG. 3, the front assembly 110 includes a syringe carrier 111 configured to be slidably mounted within the carrier support 114 between a front position and a rear position. . The syringe carrier 111 is configured to hold the syringe 180 (FIG. 8) such that the front portion of the syringe 180 extends in front of the carrier 111 (see, eg, FIG. 10). When the syringe carrier 111 is in the rear position, the syringe 180 does not protrude from the front 101 of the injector device 110 (see, eg, FIG. 15). When the syringe carrier 111 is in the forward position, the syringe (ie, at least a portion of the needle 185) protrudes from the front 101 of the injector device 100 (see, eg, FIG. 21). A carrier spring 116 biases the syringe carrier 111 toward the rear position. Specifically, the first end of the carrier spring 116 is in pressure contact with the hub 113 of the syringe carrier 111, and the second end of the spring 116 is within the carrier support 114. It is in pressure contact with the inner shoulder. An intermediate portion of the carrier spring 116 extends on the support section 112 of the syringe carrier 111.

  In some implementations, a damper configuration 190 is provided on the syringe carrier 111 and carrier support 114 (eg, to prevent destruction of the syringe 180 (FIG. 8) during infusion and delivery (eg, (See FIG. 7). For example, the damper configuration 190 may risk the syringe 180 being destroyed when the syringe 180 is advanced within the front assembly 110 and / or when the plunger 182 (FIG. 8) is advanced within the syringe 180. It can be reduced. In some implementations, the damper configuration 190 includes one or more dampers disposed on the front housing assembly 110 and / or the syringe carrier 111. In various implementations, the damper is formed from an elastic material such as rubber, foam, or gel.

  In some implementations, the first damper 192 is positioned 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 energy from the syringe carrier 111 when the syringe carrier 111 reaches the front position. Accordingly, the first damper 192 prevents energy from being transmitted to the syringe 180. In some implementations, a second damper 196 is disposed on the syringe carrier 111 to engage the syringe 180 (FIG. 7). The second damper 196 prevents destruction of the syringe 180 when the syringe carrier 111 is engaged with the carrier support in the forward position and / or when the syringe plunger is fully pushed into the syringe 180. As such, it cooperates with the first damper 192.

  In some implementations, the first damper 192 includes one or more gasket sections disposed on the carrier support 114 and facing the syringe carrier 111. In other implementations, the first damper 192 is a portion of the gripping member 194 that also extends on the outer surface of the front assembly 110 (FIG. 5). In certain implementations, the gripping member 194 is a soft / elastic / compressible material (eg, rubber) overmolded or otherwise formed on the exterior of the carrier support 114. is there. In some implementations, the second damper 196 includes a gasket ring disposed in the through path of the syringe carrier 111. In certain implementations, at least a portion of the second damper 196 is seated on the rear facing surface of the syringe carrier 111. The rear 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 that the needle 185 (FIG. 10) of the syringe 180 protrudes from the front 101 of the injector device 100 during injection. Referring back to FIG. 3, the depth adjustment assembly includes a depth adjuster 117 disposed within the depth adjuster housing 122 that couples to the carrier support 114. For example, the depth adjuster 117 may define an outer thread 118 that engages the inner thread 123 of the housing 122 (FIG. 3). In some implementations, the latch arm 119 of the depth adjuster 117 is notched in the carrier support 114 to define the individual rotational position of the depth adjuster 117 in relation to the housing 122. It may interact with the inner surface 115 (FIG. 3). Each individual rotational position corresponds to a different needle depth. In other implementations, a notched inner surface may be provided on the regulator housing 122.

  An indicator 121 (FIGS. 1 and 2) is provided on the outer surface of the depth adjuster 117 to indicate how far the needle is set to protrude. For example, a series of numbers indicating the length or distance may be formed in a spiral pattern on the outer periphery of the depth adjuster 117. The adjuster housing 122 defines a window 124 through which the depth adjuster 117 is visible (FIG. 1). As the depth adjuster 117 travels along the adjuster housing 122, the indicator 121 circulates below the window 124. In some implementations, the indicia 121 is spaced to correspond to the individual rotational positions defined by the cut out inner surface 115 of the carrier support 114. For example, in some implementations, a new indicator 121 is visible through the window 124 at each rotational position of the depth adjuster 117. In other implementations, the new sign 121 is visible at a predetermined rotational position. In some implementations, the sign 121 is large enough to facilitate reading of the sign 121 by the user. For example, at least some of the signs 121 may be 4 mm high.

  The depth adjuster 117 defines a gripping surface 120 (FIG. 2) toward the front 101 of the injector device 100. To adjust the depth of the syringe needle, the user grips the gripping surface 120 of the depth adjuster 117 and rotates the depth adjuster 117 clockwise or counterclockwise. Movement in one direction increases the depth of the needle by moving the depth adjuster 117 backward relative to the adjuster housing 122. Movement in the other direction reduces needle depth by moving the depth adjuster 117 forward relative to the adjuster housing 122.

  The sheath remover 125 is configured to be attached to the front portion 101 of the injector device 100 (FIG. 1). The sheath remover 125 covers the gripping surface 120 of the depth adjuster 117 when attached to the front assembly 110 (see, eg, FIG. 8). The sheath remover 125 is configured to be fixed to the adjuster housing 122 without being rotatably fixed to the depth adjuster 117. The rotational movement of the sheath remover 125 does not generate the rotational movement of the depth adjuster 117. Also, the axial movement of the sheath remover 125 does not generate the axial movement of the depth adjuster 117. Rather, axial movement of the sheath remover 125 in front of the depth adjuster 117 removes the sheath remover 125 from the adjuster housing 122 (see, eg, FIG. 10). The sheath remover 125 is configured to remove the sheath 186 that covers the needle 185 of the syringe 180 (see FIG. 10). Accordingly, the syringe 180 may be attached to the front assembly 110 while the sheath 186 covers the needle 185 (see FIG. 8). The sheath remover 125 facilitates removal of the sheath 186 without the possibility of a user coming into contact with the needle 185.

  As shown in FIG. 9, the sheath remover 125 includes an outer wall 126 sized to fit at the outer periphery of the depth adjuster 117. An outer latch arm 127 extends rearward from the outer wall 126 and is secured to the regulator housing 122 (FIG. 9). The sheath remover 125 also includes an inner wall 128 sized to fit within the depth adjuster 117 and around the needle sheath 186 (see FIG. 9). An inner latch arm 129 extends rearward from the inner wall 128 to capture the edge of the needle sheath 186. The sheath remover 125 is removed from the front assembly 110 by pulling the sheath remover 125 forward of the front assembly 110 with sufficient force to unlatch the outer latch arm 127 (see FIG. 10). I want to be) The inner latch arm 129 captures and carries the needle sheath 186 as the sheath remover 125 is moved away from the front assembly 110 (see FIG. 10).

  As shown in FIG. 3, the rear assembly 130 includes an outer housing configuration 131, an injection assembly 140, an inner housing 150, and a trigger configuration 170. In some implementations, the rear assembly 130 includes an interlock configuration 160 that connects the rear assembly 130 to the front assembly 110 (see, eg, FIG. 15). According to interlock configuration 160, as disclosed in further detail herein, injector device 100 is placed in an inoperable state (see FIGS. 13 and 15) that inject assembly 140 is not operable. It can be configured between a ready state in which the solid 140 can operate (see FIGS. 14 and 16). In some implementations, the rear assembly 130 includes an indicator assembly 175 (FIG. 3) that provides a completion indicator, as disclosed in more detail herein.

  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 configuration 160 (FIG. 12). The closed end is formed by a ceiling structure 154 with an edge configuration 152 extending rearward (FIG. 17). The edge configuration 152 defines one or more rear facing shoulders positioned at a location spaced rearward from the ceiling structure 154 (FIGS. 17 and 21). In one exemplary implementation, the edge configuration 152 includes two rear facing shoulders. A guide structure 153 extends behind the edge configuration 152 (FIGS. 12 and 17).

  Still referring to FIG. 3, the injection assembly 140 includes a ram 141 and a constant force spring 149 that biases the ram 141 toward the front 101 of the injector device 100. At least a portion of the ram 141 is disposed within the inner housing 150 between the open end and the closed end. The ram 141 is configured to move (eg, slide) within the inner housing 150 at least between a firing preparation position (FIG. 7) and a “bottomed out” position (FIG. 5). When in the fire ready position, the ram 141 is positioned at the closed end of the inner housing 150. When in the bottomed out position, the ram 141 is positioned closer to the open end of the inner housing 150. In certain implementations, the ram 141 may be positioned in front of the inner housing 150 when in the bottomed out position.

  The ram 141 defines an abutment surface 142 that faces toward the front 101 of the injector device 100 (FIG. 3). The abutment surface 142 is configured to contact and push the plunger 182 of the syringe 180 as it moves toward the bottomed position (see FIGS. 21 and 22). In one exemplary implementation, the abutment surface 142 is flat (see FIG. 5). In some implementations, the abutment surface 142 is spaced from the plunger 182 when the ram 141 is in the fire ready position (see FIGS. 15 and 16).

  The ram 141 also includes a latch arm 144 that extends through a hole in the ceiling structure 154 to the edge configuration 152 (see FIG. 12). The latch arm 144 defines a latch lug 145 configured to seat on the rear facing shoulder of the edge configuration 152 to releasably secure the ram 141 to the edge configuration 152 in a firing ready position ( (See FIG. 20). The lug 145 of the latch arm 144 is configured to hold the ram 141 in pressure contact with the bias of the constant force spring 149 to maintain the ram 141 in the firing preparation position.

  The ram 141 also defines a spring support section 143 (FIG. 3) at an intermediate position between the abutment surface 142 and the latch arm 144. In some implementations, a barrel 148 (FIG. 3) is attached to the spring support section 143 and a constant force spring 149 is wound around or otherwise attached around the barrel 148. (See, eg, FIG. 12). The opposite end of the spring 149 is clamped, fastened, or otherwise fixed between the inner housing 150 and the interlock configuration 160 (see FIG. 12).

  The outer housing configuration 131 includes a rear outer housing 132 that receives the inner housing 150 (see FIG. 3). A trigger arrangement 170 is attached to the rear end of the rear outer housing 132 (see FIG. 3). In some implementations, the trigger arrangement 170 is a forward-extending latch arm 172 (FIGS. 3 and FIG. 3) that snap-fits or otherwise is secured to the inner shoulder defined by the rear outer housing 132. 20) includes a button 171 (see, eg, FIG. 7). The button 171 protrudes rearward from the rear outer housing 132 (see, eg, FIG. 7).

  The button 171 is movable in relation to the rear outer housing 132 between a ready position (eg, see FIG. 5) and a depressed position (eg, see FIG. 12). The button 171 is further disposed within the rear outer housing 132 when in the depressed position than when in the ready position. A trigger spring 174 biases the button 171 to the start position (see FIG. 5). An inclined structure 173 extends forward along the hollow interior of the button 171 (FIGS. 12 and 20). By moving the button 171 in a pressed state against the bias of the trigger spring 174 from the ready position to the pressed position, the inclined structure 173 moves forward in relation to the rear outer housing 132.

  In some implementations, the indicator assembly 175 can be disposed 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 implementations, the indicator body 176 includes a colored surface. In other implementations, the indicator body 176 includes a surface on which a sign is printed. In some implementations, the indicator body 176 also includes a track follower 178 that extends radially inwardly from the body 176 to interact with the inner housing body 151 (see FIGS. 21 and 22). Wanna)

  The indicator 176 slides along the exterior of the inner housing body 151 between a rear (ie constrained) position (FIG. 21) and a front (ie biased) position (FIG. 22). It is configured. A biasing member (ie, indicator spring) 179 biases the indicator body 176 toward the front position. In some implementations, one or more tracks 156 or cutouts extend longitudinally along the peripheral wall of the hollow body 151 of the inner housing 150 (FIG. 17). In certain implementations, the track follower 178 of the indicator body 176 extends into and slides along one of the tracks 156 to prevent rotational movement of the indicator body 176. (FIG. 12). In some implementations, the track follower 178 can be utilized to reset the indicator member 176 upon loading of the infusion assembly 140, as disclosed in more detail herein.

  The indicator main body 176 is held in pressure contact with the biasing force of the indicator spring 179 by a stop portion 158 (FIGS. 17 and 20) provided on the inner housing 150. The stop 158 is disposed on one or more flexible arms 157 that extend within one or more of the cutouts in the hollow body 151 (see FIG. 17). In some implementations, the arm 157 is configured to bend radially inward toward the interior of the hollow body 151. The stop member 158 extends outward from the arm 157 that is easily bent. The indicator spring 179 is strong enough to push the stop member 158 into the cutout toward the inside of the inner housing 150 by pushing the indicator body 176 over the stop member 158 (see FIG. 22). . However, when the ram 141 is disposed in the firing ready position within the inner housing 150 (see, eg, FIG. 21), the ram 141 is a stop member, as will be described in greater detail herein. Prevent 158 inward movement. Thus, the stop member 158 holds the indicator body 176 in pressure contact with the bias of the indicator spring 179 until the ram 141 is moved to the biased position.

  The rear outer housing 132 defines at least one window aperture 133 (FIG. 3) in which the indicator body 176 is visible when the indicator body 176 is in the forward position (see, eg, FIG. 23). . The indicator body 176 is not visible through the window aperture 133 when the indicator body 176 is in the rear position (see, eg, FIG. 1). In one implementation, the rear housing 132 defines a window aperture 133 on only one of the side surfaces 103 of the housing 132. In another implementation, the rear housing 132 defines a window aperture 133 on both side surfaces 102 of the housing 132, and the indicator body 176 defines two indicator bodies 176. In certain implementations, the window configuration 134 (FIG. 3) may be fixedly disposed within the rear outer housing 132 at the window aperture 133. The window arrangement 134 is formed from a translucent or semi-translucent material that fills the aperture 133 to protect the interior of the injector device 100.

  The outer housing configuration 131 also includes an intermediate outer housing 137 that fits in one with the rear outer housing 132 (see FIG. 3). The intermediate outer housing 137 defines a support structure 138 that extends inwardly from the inner surface of the intermediate outer housing 137 (see FIG. 12). Support structure 138 defines a front facing shoulder 139 (FIG. 12).

  In some implementations, one or both of the housings 132, 137 may include gripping surfaces 135, 137, respectively, to facilitate gripping of the injector device 100 (see FIG. 1). . In some implementations, the gripping surfaces 135, 137 extend on at least a portion of the outer surface of the housings 132, 137. In certain implementations, the gripping surfaces 135, 137 are formed from a compressible material. In one exemplary implementation, the gripping surfaces 135, 137 are formed from rubber.

  An interlock configuration 160 couples the front assembly 110 to the rear assembly 130 (see FIG. 15). The interlock configuration 160 includes an interlock body 161 that defines an internal thread 162 at the front end (FIGS. 3 and 12). The rear end of the interlock main body 161 is configured to be attached to the inner housing 150 (FIG. 12). Internal thread 162 engages with external thread 163 disposed on carrier support 114 (see FIG. 11) to releasably couple rear assembly 130 to front assembly 110. Is sized to do.

  In some implementations, the internal thread 162 and the external thread 163 are configured to facilitate high-speed threading of the front and rear assemblies 110, 130. For example, in certain implementations, each of the internal threads 162 and the external threads 163 extend no more than twice along the inner circumference of the individual assembly 110, 130 (FIGS. 11 and 11). (See FIG. 12). In certain implementations, each of the inner thread 162 and the outer thread 163 extends along the inner circumference more than once and less than twice. In certain implementations, each of the internal thread 162 and the external thread 163 extends no more than once along the inner circumference of the individual assembly 110, 130. In certain implementations, each of the internal and external threads 162, 163 extend along about half of the inner circumference of the individual assembly 110, 130.

  As shown in FIG. 12, the inner housing 150 is configured to releasably lock with respect to the intermediate outer housing 137. Inner housing 150 defines an interlock arm 155 that extends in front of a fixed shoulder 164. The interlock arm 155 includes a bendable arm configured to deflect inward relative to the rest of the inner housing 150 (see FIG. 15). The interlock arm 155 includes a latch hook that extends radially outward from the arm 155 to define a rear facing shoulder 159 (FIG. 12). The free end of the interlock arm 155 defines an inclined or contoured surface 169 that is tapered or curved laterally across the arm 155 (see FIGS. 18 and 19).

  When the rear outer housing 132 and the intermediate outer housing 137 are mounted on the inner housing 150, the support member 138 of the intermediate housing 137 has a fixed shoulder 164 of the inner housing 150 and a rear facing shoulder 159 of the latch hook. (Fig. 12). Accordingly, the outer housing assembly 131 is held in a stationary state in relation to the inner housing 150 and the interlock main body 161. A portion (eg, a band) of the interlock body 161 extends between the front assembly 110 and the rear assembly 130 (see FIG. 13).

  4-7 illustrate the manner in which the injector device 100 is armed (ie, the manner in which the ram 141 (FIG. 3) is moved from the bottomed position to the firing preparation position). As shown in FIG. 4, the front assembly 110 is removed from the rear assembly 130 (eg, by unscrewing the carrier support 114 from the interlock body 161). As shown in FIG. 5, the front assembly 110 is inverted so that the sheath remover 125 faces the rear assembly 130. As shown in FIGS. 6 and 7, the front end of the front assembly 110 is inserted into the rear assembly 130 and slid rearwardly within the inner housing 150.

  The front end of the front assembly 110 engages the ram 141 and pushes the ram 141 backward in the inner housing 150 toward the ceiling structure 154 (see FIG. 6). For example, in some implementations, the sheath remover 125 is pressed against the abutment surface 142 of the ram 141. In other implementations, the depth adjuster 117 is pressed against the abutment surface 142 in a pressed state. The ram 141 is moved backward in a pressure contact state against the bias of the constant force spring 149. The ceiling structure 154 prevents the ram 141 from being moved excessively backwards. As the ram 141 moves rearward, the latch arm 144 moves past the ceiling structure 154 toward the edge configuration 152 until the latch lug 145 sits on the rear shoulder of the edge configuration 152 in the firing preparation position. Exercise (see FIG. 20).

  8-11 illustrate the mounting of the syringe 180 within the front assembly 110. FIG. Syringe 180 includes an ampoule 181 configured to hold a drug. A plunger 182 extends through the rear end of the ampule 181 to a piston or plug 183 that seals the drug in the ampule 181. A needle 185 (FIG. 10) is coupled to the needle hub 184 at the front end of the ampoule 181. A sheath 186 surrounds the needle 185 (see, eg, FIG. 9). The sheath 186 prevents a person handling the syringe from being accidentally punctured or punctured by the needle 185.

  As shown in FIG. 8, the syringe 180 is inserted into the rear end of the front assembly 110. The end of the syringe 180 having the sheath is inserted through the syringe carrier 111 such that the support section 112 of the carrier 111 surrounds a portion of the ampoule 181 (see, eg, FIGS. 9 and 10). The syringe 180 is inserted sufficiently deep into the front assembly 110 such that the needle sheath 186 extends within the inner wall 128 of the sheath remover 125. The latch arm 129 of the inner wall 128 engages or otherwise is secured on the end of the sheath 186 (see FIG. 9).

  As shown in FIG. 10, the sheath remover 125 captures the sheath 186 when the sheath remover 125 is pulled in front of the front assembly 110, thereby removing the sheath 186 from the needle 185. To do. As shown in FIG. 11, the gripping surface 120 of the depth adjuster 117 is accessible when the sheath remover 125 is removed. The plunger 182 extends behind the ampoule 181 and the front assembly 110 when the syringe is attached to the syringe carrier 111.

  FIG. 12 shows a cross section of the rear assembly 130 after the infusion assembly 130 is enabled and the injector device 100 is disabled. While in the unusable configuration, actuation of trigger 170 does not cause injection assembly 140 to fire. The ram 141 is disposed in the firing preparation position, and the latch lug 145 of the ram 141 is seated on the edge configuration 152 of the inner housing body 151. The constant force spring 149 is in a load application state.

  The indicator body 176 is held in a constrained position while being pressed against the bias of the indicator spring 179. Specifically, the ram 141 prevents inward bending of the flexible arm 157 of the inner housing 150 that allows the stop 158 (FIG. 18) to hold the indicator body 176. Further, the shoulder 147 of the ram 141 may engage the track follower 178 to prevent forward movement of the indicator body 176 (FIG. 12). The shoulder 147 can also push the track follower 178 in a press-contact condition when enabling the infusion device 140 to reset the indicator body 176 in the rear position (see, eg, FIGS. 5 and 7). I want to be)

  While the injector device 100 is disabled, the inner housing body 151 is axially fixed relative to the outer housing assembly 131 (see FIG. 12). The fixed shoulder 164 of the inner housing body 51 is seated in pressure contact with one end of the support member 138 of the intermediate outer housing 137, and thereby the front axial direction of the inner housing 150 in relation to the rear outer housing 132. Obstructing exercise. The latch hook (ie, the rear facing shoulder 159) of the interlock arm 155 engages the shoulder 139 at the opposite end of the support member 138, thereby allowing the rear outer housing 132 in relation to the inner housing 150. This hinders forward axial movement (FIG. 12). Furthermore, the trigger spring 174 biases the rear outer housing 132 in the extended position relative to the inner housing 150 (FIG. 12). For example, one end of the spring 179 is seated on the ceiling structure 154 of the inner housing 150, and the opposite end of the spring 179 presses the inside of the button 171 in a pressed state (see FIG. 12). I want to be)

  As shown in FIG. 12, if the trigger button 171 is depressed while the rear outer housing 132 is in the extended position, the infusion assembly 140 will not operate. By pressing the trigger button 171 into the rear outer housing 132, the inclined structure 172 inside the button 171 moves forward toward the edge structure 152 of the inner housing 150. However, the inclined structure 173 does not reach the latch lug 145 of the ram latch arm 144 even when the button 171 is fully pushed. Accordingly, the button ramp structure 173 cannot unlatch the latch arm 144 from the edge structure 152 to actuate the infusion assembly 140.

  FIGS. 13-19 show the manner in which the injector device 100 transitions from an unusable configuration to a usable configuration. As shown in FIG. 13, the front assembly 110 is attached to the rear assembly 130 such that the band of the interlock body 161 is visible between the carrier support 114 and the intermediate outer housing 137. It is installed. 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 may notify the rear assembly 130 until the first and second alignment indicators 165, 166 point to each other to indicate the rotational alignment status of the front and rear assemblies 110, 130. It may be screwed. As shown in FIG. 14, when the front and rear assemblies 110, 130 are rotationally aligned, the rear assembly 130 has an interlock body 161 in which the intermediate outer housing 137 was visible. May be moved axially forward toward the front assembly 110 (compare FIGS. 13 and 14).

  15 and 16 are axial cross-sectional views of the injector device 100 showing the transition from the unusable configuration to the usable configuration. When in an unusable configuration, the axial spacing between the edge structure 152 of the inner housing 150 and the rear end 102 of the rear outer housing 132 is such that the latch lug of the ram 141 is also depressed when the trigger button 171 is pushed It is sufficient to maintain the separation of the ramp structure 173 of the trigger button 171 from 145 (see, eg, FIG. 15). Thus, if the trigger button 171 is depressed while the injector device 100 is in a disabled configuration, the injector assembly 140 will not operate.

  After the latch arm 155 is unlocked (ie, bent inward), the rear outer housing 132 is pressed against the bias of the trigger spring 174 in relation to the inner housing 150 and the front assembly 110. In the state, it can be moved to the forward retreat position. The rear outer housing 132 moves to cover the interlock body 161 so that the interlock body 161 is no longer visible to the user. As shown in FIG. 16, by sliding the rear outer housing 132 to the retracted position, the trigger button 171 is in a relatively close state to the edge structure 152 and the ram latch lug 145. By depressing the trigger button 171 of the new available injector device 100, the ramp structure 173 moves into engagement with the latch lug 145 of the ram latch arm 144.

  17-19 illustrate a manner in which the interlock configuration 160 allows the injector device 100 to transition from an unusable configuration to a usable configuration. As shown in FIG. 17, the front assembly 110 includes one or more rearwardly extending tabs 167 (eg, disposed at the rear of the carrier support 114). As shown in FIG. 19, the rearward extending tab 167 interacts with a sloped or otherwise contoured surface 169 at the free end of the interlock arm 155 of the inner housing 150. A sloped or otherwise contoured surface 168 is defined. For example, the tab 167 may rest on the snapover surface 169a of the contoured surface 169. In certain implementations, the tab 167 generates an audible sound (eg, a click) when the tab 167 is placed on the snapover surface 169a.

  When the front assembly 110 is screwably coupled to the rear assembly 130, the tabs 167 extending rearward of the front assembly 110 are interlocked arms 155 as shown in FIG. Is engaged with the free end of the interlock arm 155 to deflect the radial direction inward. By bending the interlock arm 155 inward, the latch hook (and thus the rear facing shoulder 159) of the interlock arm 155 moves away from the support member 138 of the inner housing 150 (see FIG. 15). I want to be) The rear outer housing assembly 132 can be moved forward relative to the interlock body 161 while the interlock arm 155 is held in an inwardly bent position (see FIG. 16). .

  In some implementations, the interlock assembly 160 includes a latch spring 189 (FIG. 3) that biases the interlock arm 155 radially outward in the locked position. In some implementations, the latch spring 189 provides support to the interlock arm 155 to prevent destruction of the arm 155 after repeated use. In such a mounting form, the interlock arm 155 is biased toward the lock position mainly due to the elasticity and elasticity of the material of the interlock arm 155 itself. In other implementations, the latch spring 189 functions to maintain the interlock arm 155 in the locked position.

  16 and 20-22 illustrate the operation of the injection assembly 140 of the injector device 100. FIG. As shown in FIG. 16, the injector device 100 is configured in a usable configuration to initiate an infusion. The carrier spring 116 urges the syringe carrier 111 rearward so that the needle 185 is disposed in the depth adjuster 117. The syringe plunger 182 extends rearward toward the ram 141 disposed in the firing preparation position. In certain implementations, the abutment surface 142 of the ram 141 is axially spaced from the syringe plunger 182. In other implementations, the ram 141 abuts the syringe plunger 182. The trigger button 171 is present in the reach of the latch lug 145 of the ram latch arm 144.

  As shown in FIG. 20, when the trigger button 171 is pressed in the pressing direction D, the tilt structure 173 causes the latch lug 145 of the ram latch arm 144 to bend away from the edge structure 152 of the inner housing 150. Press at. In certain implementations, the edge structure 152 causes the latch lug 145 to move in the lateral bending direction F so that the ram 141 biases the constant force spring 149 until the latch lug 145 clears the edge structure 152. Is contoured so as to move backward in a pressure contact state (see FIG. 20). When the latch lug 145 clears the edge structure 152, the ram 141 is no longer held in pressure contact against the bias of the constant force spring 149.

  As shown in FIG. 21, the constant force spring 149 pulls the ram 141 forward toward the biased position when the ram 141 is no longer held in the firing ready position. As the ram 141 moves forward, the abutment surface 142 of the ram 141 engages the syringe plunger 182. However, the ram 141 does not immediately move the plunger 182 within the ampoule 181. Rather, the compression resistance of the carrier spring 116 is small enough so that the carrier spring 116 begins to compress before the plunger 182 begins to move within the ampoule 181. As the carrier spring 116 is compressed, the hub 113 of the syringe carrier 111 engages with the front wall of the carrier support 114 (for example, engages with the first damper 192). Up to a point, it moves forward in relation to the carrier support 114. The syringe carrier 111 carries the syringe 180 in the forward direction, thereby inserting the needle 185 into the injection site.

  As shown in FIG. 22, the ram 141 depresses the plunger 182 within the ampoule 181 to deliver the drug. When the syringe carrier 111 bottoms out (ie, engages the front wall), the forward force of the ram 141 is sufficient to overcome the resistance force of the plunger 182. Since the ram spring 149 is a constant force spring, the drug is delivered from the syringe 180 at a more consistent rate than by a coil spring. After the drug is delivered, the ram spring 149 maintains a forward pressure on the syringe plunger 182. Accordingly, the syringe needle 185 remains in a state of extending from the front end 101 of the injector device 100 even after the injector device 100 is removed from the injection site.

  With reference to FIGS. 16, 21, and 22, the burst completion indicator 175 is automatically activated by the infusion assembly 140. As shown in FIG. 16, the indicator main body 176 is disposed in the rear position in a pressure contact state against the bias of the indicator spring 179 before the trigger button 171 is actuated. While in the firing preparation position, the ram 141 prevents inward bending of the arm 157 of the inner housing 150. Therefore, the stop member 158 (FIG. 20) holds the indicator body 176 in a pressure contact state against the bias of the spring 179. Furthermore, the shoulder 147 of the ram 141 is engaged with the track follower 178 of the indicator body 176 (FIG. 16). As shown in FIG. 21, the indicator body 176 is still held in a rearward position because the ram 141 extends along a portion of the arm 157 that still remains flexible.

  As shown in FIG. 22, the indicator body 176 moves fully forward in the inner housing 150 to allow the ram 141 to clear the bendable arm 157 and allow inward movement of the stop member 158. When it is done, it is biased on the stop member 158. In the illustrated example, the ram 141 clears the arm 157 which is easy to bend when the piston 183 bottoms out in the syringe ampoule 181. In other implementations, the ram 141 moves forward enough to deliver a predetermined amount of medication from the syringe 180 (even when the piston 183 is not completely “bottomed”), for example. The arm 157 that is easy to bend is cleared.

  The indicator spring 179 pushes the indicator body 176 forward on the inner housing 150. As the housing 176 slides forward, the track follower 178 slides in a longitudinal track 156 defined in the sidewall of the inner housing body 151. The track follower 178 prevents the indicator member 176 from rotating as the indicator member 176 moves forward. Accordingly, the track follower 178 prevents the indicator body 176 from deviating from the ambient alignment with the window 134 (FIG. 1).

  As shown in FIG. 22, the indicator body 176 is radially aligned with the window 134 when a drug is dispensed. As shown in FIG. 1, the inner housing body 151 is visible through the window 134 before the indicator body 176 is aligned with the window 134. As shown in FIG. 22, the indicator body 176 is visible through the window 124 when delivery is complete. In some implementations, the indicator body 176 is a different color (eg, red) than the inner housing body 151 (eg, white). Thus, a sudden color change in the window 134 signals the completion of the injection process.

  As noted above, the phrase “on completion” refers to the moment of completion, the time immediately following the moment of completion, or the time within a few milliseconds before and after completion (eg, due to tolerances within the injector device). )). When multiple events occur "on completion", these events may occur simultaneously, directly in succession, or within a few milliseconds of each other. In some implementations, the track follower 178 may be audible noise (eg, “click”) when the indicator body 176 reaches a forward position and the track follower 178 engages the shoulder 177 of the inner housing 150. (See FIG. 22). Thus, in some implementations, the sudden completion indicator 175 is generating audible noise to signal the completion of the delivery step.

  In some implementations, the indicator spring 179 is strong enough that the indicator body 176 appears to be filling the window 134 momentarily. For example, the indicator spring 179 may cause the indicator body 176 to move quickly forward such that the user cannot follow the movement of the front end of the indicator body 176 along the window 134. In certain implementations, the movement of indicator body 176 relative to window 134 is not tied to (ie, isolated from) movement of plunger 182 within syringe ampoule 181. For example, once the bendable arm 157 is cleared, the indicator body 176 moves forward by the indicator spring 179 without being affected by the position of the ram 141 within the inner housing body 151.

  The injector device 100 described above is configured for use with a syringe containing an injectable fluid. One exemplary fluid suitable for accommodation in a syringe is glatiramer acetate. Glatilamer Acetate (GA), also called Copolymer-1, has been shown to be effective in treating multiple sclerosis (MS) (Lampert, 1978). Daily subcutaneous infusions of glatiramer acetate (20 mg / infusion) have included recurrence rates, progression of lesions, emergence of new lesions with magnetic resonance imaging (MRI) (Johnson, 1995), and “black hole” Reduce appearance (Filippi, 2001).

COPAXONE® is a brand name for a formulation that contains glatiramer acetate as an active ingredient. Glatiramer acetate has been approved for reducing the frequency of relapses in Relapsing-Remitting Multiple Sclerosis (RRMS). Glatimer acetate is referred to as L-glutamic acid, L-aramine, L-tyrosine, and L-lysine, with average molar fractions in COPAXINE® of 0.141, 0.427, 0.095, and 0.338, respectively. It is composed of acetate of synthetic polypeptide containing 4 naturally occurring amino acids. In COPAXION®, the average molecular weight of glatiramer acetate is 4700-11000 daltons. Chemically, glatiramer acetate is denoted as L-glutamic acid polymer with L-alanine, L-lysine, and L-tyrosine acetate (salt). Its structural prescription is as follows.
(Glu, Ala, Lys, Tyr) _x ACH ₃ COOH
(C ₅ H ₉ NO ₄ AC ₃ H ₇ NO ₂ AC ₆ H ₁₄ N ₂ O ₂ AC ₉ H ₁₁ NO ₃ ) _P APC ₂ H ₄ O ₂
CAS-147245-92-9

  The recommended dosing schedule for COPAXONE® for relapsing-remitting multiple sclerosis is 20 mg per day when injected subcutaneously (Physician's Desk Reference). Further information regarding dosing schedules can be found in US Pat. Nos. 3,849,550, 5,800,808, 5,858,964, 5,981,589, 6,048,898. No. 6,054,430, 6,214,791, 6,342,476, and 6,362,161, the disclosures of which are as follows: Incorporated herein by reference.

  Although its mechanism of action has not been fully elucidated, it is believed that GA binds to and is displayed as an antigen in the groove of the major histocompatibility complex (MHC) molecule. It has been. Alternatively, GA is considered to be enveloped by an antigen presenting cell (APC) and then a fragment is provided. In either case, the provision of GA results in the generation of GA-specific T cells. Through mechanisms that remain unclear, GA-specific T cells are predominantly T helper 2 (Th2) biased. Th2 cells produce Th2 cytokines that interfere with the production of cytokines by Th1 cells or microphages and tend to be anti-inflammatory. Unlike interferon beta, which has effective activity at the Blood-Brain Barrier (BBB) and reduces the transport of inflammatory cells into the CNS, GA has a negligible effect on the BBB. This allows GA-specific Th2 lymphocytes to enter the CNS and reduce inflammation through bystander suppression (Yong, 2002).

  Some aspects of the injector device include (a) a first housing assembly configured to hold a syringe, (b) a second housing assembly including an outer housing and an inner housing, (c) in an extended position. A locking member for holding the outer housing in a fixed state; and (d) an interlock assembly configured to rotatably mount the first housing assembly to the second housing assembly at a specific rotational position. The inner housing is configured to be fixed in the axial direction relative to the first housing assembly. The outer housing is configured to move axially in relation to the first housing assembly between an extended position and a retracted position. The second housing assembly includes an infusion assembly configured to operate the syringe to infuse medication from the syringe. The second housing assembly includes a trigger member configured to fire the injection assembly only when the outer housing is in the retracted position. The second housing assembly includes a biasing member that biases the outer housing to the extended position. The interlock assembly is also configured to release the locking member when the first and second housing assemblies are in a particular rotational position. The outer housing is movable to a retracted position in relation to the first housing assembly in a pressure contact state against the bias of the biasing member when the lock member is released.

  In a particular exemplary implementation, the first housing assembly includes a first alignment indicator and the outer housing of the second housing assembly includes a second alignment indicator, wherein the first and The second alignment indicator aligns when the first and second housing assemblies are oriented at a particular rotational position.

  In an exemplary implementation, the interlock assembly is visible between the first housing assembly and the second housing assembly when the outer housing is disposed in the extended position. Including the band, where the interlock band is not visible when the outer housing is in the retracted position.

  In a particular exemplary implementation, the locking member includes a bendable latch hook disposed on the inner housing such that the latch hook engages a shoulder disposed within the outer housing. In this case, the interlock assembly includes a tab that bends the latch hook away from the shoulder when the first and second housing assemblies are oriented in a particular rotational position.

  In an exemplary implementation, the trigger member includes a button attached to the outer housing and configured to move between a ready position and a depressed position. The button is spaced sufficiently far from the infusion assembly when the outer housing is in the extended position to prevent the button from firing the infusion assembly when in the depressed position. ing. By moving the outer housing to the retracted position, the button is sufficiently close to the injection assembly to allow the injection assembly to fire when the button is moved to the depressed position. Exercise.

  In certain exemplary implementations, the infusion assembly includes a ram and a spring that biases the ram toward the syringe. The ram includes a flexible latch arm that engages a shoulder defined by the inner housing to hold the ram in pressure contact with a spring bias. The step of moving the button sufficiently close to the infusion assembly is such that the movement of the button to the depressed position causes the flexible latch to be pushed away from the shoulder to release the ram. Moving within the range of the latch that is liable to bend.

  In certain exemplary implementations, the biasing member biases the outer housing toward the extended position by biasing the button away from the inner housing and toward the ready position.

  In an exemplary implementation, the outer housing is pressed against the injection side with the first housing assembly and the user grips the outer housing and pushes the outer housing toward the injection site. When moving in relation to the first housing assembly.

  In a specific exemplary implementation, the syringe contains a formulation that includes glatiramer acetate. In one exemplary implementation, the formulation contains 20 mg glatiramer acetate per 1 ML formulation. In one exemplary implementation, the formulation contains 40 mg glatiramer acetate per 1 ML formulation.

  In certain exemplary implementations, the syringe includes a needle configured to extend from the first housing assembly in the dispensing step, and in this case, the first housing assembly includes the first housing. It includes a depth adjuster that varies the length of the needle extending from the assembly.

  In an exemplary implementation, the depth adjuster is movable between individual stop positions, each individual stop position being a depth relative to one of the individual stop positions. Different needle depths are accommodated such that by moving the adjuster, the corresponding needle depth is selected.

  In a specific exemplary implementation, a needle sheath remover is fitted over the depth adjuster. The needle sheath remover is configured to couple to the depth adjuster such that the depth adjuster remains axially and rotationally fixed during any movement of the needle sheath remover. ing.

  In an exemplary implementation, numbers are displayed on the depth adjuster to indicate the needle depth, where the displayed numbers are at least 4 mm in size.

  In certain exemplary implementations, the second housing assembly includes a compressible gripping surface that extends on a portion of the exterior of the second housing assembly.

  In a specific exemplary implementation, each of the first and second housing assemblies has a threaded region that is secured to the other threaded region for coupling to the first and second housing assemblies. including.

  In an exemplary implementation, each of the threaded regions includes a thread that extends along the inner circumference or less of the individual housing assembly.

  In a specific exemplary implementation, the threads of the respective threaded region extend along about half of the inner circumference of the individual housing assembly.

  In a specific exemplary implementation, the first housing assembly includes a first tab and the second housing assembly defines a snapover surface, where the first tab is When the first and second housing assemblies are screwed together, they are placed on the snapover surface, and in this case, the first tab is placed on the snapover surface. When done, it generates audible sound.

  In certain exemplary implementations, a burst completion indicator member is disposed within the outer housing. The burst completion indicator member is configured to move in relation to the outer housing between the first position and the second position. The burst completion indicator member is not visible through the window defined in the outer housing when in the first position, and is visible through the window when in the second position. In some cases, the movement of the sudden completion indicator member from the first position to the second position is activated upon completion of the dispensing step.

  In an exemplary implementation, the color change is visible through the window when the sudden completion indicator member moves from the first position to the second position.

  In an exemplary implementation, the injector device generates audible sound upon completion of the delivery step.

  In an exemplary implementation, the burst completion indicator member is biased toward the second position by the biasing member, and in this case, the injection assembly is a burst completion indicator member. At least one stop member that holds the biasing member in pressure contact with the biasing member, the stop member automatically releasing the indicator member upon completion of the feeding step.

  The above specifications, examples and data provide a complete description of the manufacture and use of the invention. Since many embodiments of the invention can be made without departing from the spirit and scope of the invention, the invention is as defined in the appended claims.

References
1. Lampert, Autoimmune and virus-induced demyelinating diseases. A review, Am. J, Path, 1978, 91: 176-208.
2. Johnson et al., Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind placebo-controlled trial.The Copolymer 1 Multiple Sclerosis Study Group, Neurol., 1995, 45: 1268.
3.Filippi et al., Glatiramer acetate reduces the proportion of MS lesions evolving into black holes, Neurol, 2001, 57: 731-733.
4. "COPAXONE®" in Physician's Desk Reference, Thompson Reuters-Physician's Desk Reference Inc., Montvale, NJ, 2008, 31 10-3113.
5. Yong (2002) "Differential mechanisms of action of interferon-β and glatiramer acetate in MS" Neurology, 59: 1-7.

Claims (24)

An injector device,
(A) a first housing assembly configured to hold a syringe;
(B) a second housing assembly including an outer housing and an inner housing, wherein the inner housing is configured to be axially fixed in relation to the first housing assembly; Is configured to move axially in relation to the first housing assembly between an extended position and a retracted position, the second housing assembly being adapted to inject medication from the syringe. An injection assembly configured to operate the syringe, the second housing assembly including a trigger member configured to fire the injection assembly only when the outer housing is in the retracted position. And the second housing assembly includes a biasing member that biases the outer housing to the extended position;
(C) a locking member for holding the outer housing in a fixed state at the extended position;
(D) an interlock assembly configured to rotatably mount the first housing assembly to the second housing assembly at a specific rotational position, the interlock assembly comprising the first housing assembly; And the second housing assembly is also configured to release the locking member when in the particular rotational position, and the outer housing is configured to release the locking member when the locking member is released. An interlock assembly movable to the retracted position in relation to the first housing assembly in pressure contact with the bias;
An injector device comprising: The first housing assembly includes a first alignment indicator, and the outer housing of the second housing assembly includes a second alignment indicator, wherein the first and second alignment indicators are the first and second alignment indicators. The injector device of claim 1, wherein the second housing assembly is aligned when oriented at the particular rotational position.   The interlock assembly includes an interlock band that is visible between the first housing assembly and the second housing assembly when the outer housing is disposed in the extended position; The injector device of claim 1, wherein the interlock band is not visible when the outer housing is in the retracted position.   The locking member includes a bendable latch hook disposed on the inner housing, the latch hook configured to engage a shoulder disposed within the outer housing; The interlock assembly of claim 1, wherein the interlock assembly includes a tab that bends the latch hook away from the shoulder when the first and second housing assemblies are oriented in the particular rotational position. Injector device.   The trigger member includes a button attached to the outer housing and configured to move between a ready position and a depressed position, wherein the button is also in the depressed position, In order to prevent the button from firing the infusion assembly, the outer housing is spaced far enough from the infusion assembly when disposed in the extended position and the outer housing By moving the housing to the retracted position, the button moves sufficiently close to the infusion assembly to allow firing of the infusion assembly when moved to the depressed position. The injector device according to claim 4. The infusion assembly includes a ram and a spring that biases the ram toward the syringe, the ram being inwardly held to press the ram against the bias of the spring. Including a bendable latch arm that couples to a shoulder defined by the housing, and moving the button sufficiently close to the infusion assembly causes the button to move to the depressed position by moving the ram in order to release, so that said pliable latch is pushed into and out from the shoulder portion includes moving the said button within the scope of the pliable latch injector device of claim 5.   7. The biasing member of claim 6, wherein the biasing member biases the outer housing toward the extended position by biasing the button away from the inner housing and toward the ready position. Injector device.   The outer housing is pressed when the first housing assembly is pressed against the injection side and the user grips the outer housing and pushes the outer housing toward the injection site. The injector device of claim 4, wherein the injector device moves in relation to the first housing assembly.   The injector device of claim 1, wherein the syringe contains a formulation having glatiramer acetate.   The injector device of claim 9, wherein the formulation is a 1 milliliter formulation with 20 mg glatiramer acetate.   The injector device of claim 9, wherein the formulation is a 1 milliliter formulation with 40 mg glatiramer acetate.   The syringe includes a needle configured to extend from the first housing assembly in a dispensing step, and the first housing assembly extends the length of the needle extending from the first housing assembly. The injector device according to claim 1, comprising a depth adjuster that varies. The depth adjuster is moveable between individual stop positions, each individual stop position being accommodated by moving the depth adjuster to one of the individual stop positions. as the depth of the needles is selected to correspond to the depth of the different needle injector device of claim 12.   The needle sheath remover further includes a needle sheath remover that fits on the depth adjuster, the needle sheath remover being axially and rotationally during any movement of the needle sheath remover. The injector device of claim 12, wherein the injector device is configured to couple to the first housing assembly so as to remain fixed to the first housing assembly.   13. The injector device of claim 12, wherein a number is displayed on the depth adjuster to indicate needle depth, and the displayed number is at least 4 mm in size.   The injector device of claim 1, wherein the second housing assembly includes a compressible gripping surface extending on a portion of the exterior of the second housing assembly. Each of the first and second housing assemblies, in order to couple the first and second housing assembly includes a threaded region which is secured to the threaded region of the mating, implantation according to claim 1 Equipment. The injector device of claim 17, wherein each thread region includes a thread extending along an inner circumference or less of each housing assembly. The injector device of claim 18, wherein the thread of each thread region extends along approximately half of the inner circumference of each housing assembly.   The first housing assembly includes a first tab, and the second housing assembly defines a snapover surface, the first tab comprising one of the first and second housing assemblies. And the first tab generates an audible sound when the first tab is placed on the snapover surface when screwed into the snapover surface. Item 19. The injector device according to Item 18.   And a burst completion indicator member disposed within the outer housing, the burst completion indicator member moving between the first position and the second position in relation to the outer housing. The burst completion indicator member is not visible through the window defined in the outer housing when in the first position and is not visible when in the second position. The injector device of claim 1, wherein the movement of the sudden completion indicator member from the first position to the second position is activated upon completion of the dispensing step.   The injector device of claim 21, wherein a color change is visible through the window when the burst completion indicator member is moved from the first position to the second position.   The injector device of claim 21, wherein the injector device generates audible sound upon completion of the delivery step.   The burst completion indicator member is biased toward the second position by a biasing member, and the injection assembly is in pressure contact with the bias of the biasing member. 24. The injector device of claim 21, comprising at least one stop member holding a member, the stop member automatically releasing the indicator member upon completion of the dispensing step.

Images