RU2621118C2 - Autoinjector - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: device comprises: a housing with a proximal end and a distal end; a carrier adapted to receive a syringe; and a start button. In the first state, the start button is connected to the body and/or carrier and abuts the distal end of the housing. In the intermediate state, the housing is moved proximally relative to the carrier and the start button, at that, the start button is engaged with the carrier. In the second state, the start button and the carrier are moved proximally relative to the housing, at that, the start button is disengaged from the carrier and engaged with the housing.

EFFECT: increased convenience.

9 cl, 28 dwg

Description

FIELD OF TECHNOLOGY

The invention relates to an auto-injector for administering a dose of a drug substance.

BACKGROUND OF THE INVENTION

The injection is an operation associated with many risks and problems for users and medical workers, both mental and physical.

Injection devices (i.e., devices capable of delivering drugs from a drug container) are usually divided into two categories - hand-operated devices and auto-injectors.

In a manual device, the user must communicate mechanical energy to move the fluid through the needle. Usually this is done with some kind of button / plunger that the user must continuously press during the injection. With this approach, the user experiences many inconveniences. If the user stops applying pressure to the button / plunger, the injection also stops. This means that the user can enter an insufficient dose if the device is not used properly (i.e., the plunger is not fully squeezed into its final position). The injection effort may be too much for the user, especially if the patient is old or limited in movement.

The button / plunger may protrude too far. Thus, it may be inconvenient for the user to reach the fully protruding button. The combination of the injection force and the button protruding can lead to trembling / shaking of the hand, which in turn increases discomfort as the inserted needle makes movements.

Autoinjection devices are designed to make it easier for patients to inject themselves. Modern self-injection treatments include the use of drugs for diabetes (both insulin and newer drugs of the GLP-1 class), migraines, hormone therapy, anticoagulants, etc. Autoinjectors are devices that completely or partially replace the actions necessary for parenteral administration of a drug from standard syringes. Such actions may include removing the protective cap of the syringe, inserting the needle into the patient’s skin, injecting the drug, removing the needle, inserting the needle into the protective casing, and preventing reuse of the device. This eliminates many of the disadvantages of manual devices. Injection efforts / button protrusions, hand tremors, and the likelihood of an incomplete dose delivery are reduced. The trigger action can be performed using a variety of means, for example, a trigger button or the action of a needle that has reached its injection depth. In some devices, energy for fluid delivery is provided by a spring.

US 2002/0095120 A1 discloses an automatic injection device that automatically introduces a predetermined amount of a drug in the form of a fluid when the tension spring is released. A tension spring moves the ampoule and injection needle from its original position to its working position when it is unlocked. Then the contents of the ampoule are displayed by a tension spring, causing the piston to move forward into the ampoule. After the drug is injected in the form of a fluid, the torsion energy stored in the tension spring is released, after which the injection needle automatically returns to its original position.

High viscosity drugs require a lot of effort to displace them through a relatively thin injection needle. To develop such efforts, powerful drive springs are required. This can lead to the fact that the user will experience a powerful impact when the needle is inserted into the skin, as well as the user will experience high power loads when initiating the injection.

SUMMARY OF THE INVENTION

An object of the present invention is to provide an improved autoinjector.

This problem is solved using the autoinjector according to paragraph 1 of the claims.

Preferred embodiments of the invention are presented in the dependent claims.

In the context of the present application, the term “proximal” refers to the direction toward the patient during the injection, while the term “distal” refers to the opposite direction from the patient. The term “inward” refers to the radial direction toward the longitudinal axis of the autoinjector, and the term “outward” refers to the opposite direction radially facing from the longitudinal axis.

In one example embodiment, the injection device for administering a dose of a drug substance comprises a body having a proximal end and a distal end, a carrier configured to place a syringe, and a trigger. In the first state, the start button is connected to the housing and / or the carrier and abuts against the distal end of the housing. In the intermediate state, the housing moves proximally relative to the carrier and the start button, while the start button engages with the carrier. In the second state, the start button and the carrier move proximally relative to the body, while the start button disengages from the carrier and engages with the body.

In one example embodiment, the start button includes a bendable beam configured to mesh with the housing and carrier. The housing includes a housing retainer configured to engage the beam. The beam includes a first inclined member adapted to engage with a housing lock. The carrier includes a carrier retainer configured to engage the beam. The beam includes a second inclined element configured to engage with a carrier lock. In the first state, the beam engages with the housing retainer and / or the carrier retainer. In the second state, the beam engages with the housing retainer, while the beam abuts against the carrier. In the intermediate state, the beam engages with the carrier lock, while the beam abuts against the housing.

An additional scope of the present invention will become apparent from the detailed description below. However, it should be understood that the detailed description and specific examples indicating preferred embodiments of the invention are given only as an illustration, since various possible changes and modifications within the scope of the invention will become apparent to those skilled in the art.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will become clearer from the following detailed description and the accompanying drawings, presented only as an illustration, and therefore not limiting the present invention, where:

the figure 1 shows two longitudinal sections of the autoinjector after removing the cap and the protective cover of the needle,

figure 2 shows two longitudinal sections of an autoinjector when the body is moved in the proximal direction relative to the frame,

figure 3 shows two longitudinal sections of the autoinjector when the start button is pressed,

the figure 4 shows two longitudinal sections of the autoinjector during the extension of the needle,

figure 5 shows two longitudinal sections of the autoinjector when the needle is in the extended proximal position,

figure 6 shows two longitudinal sections of an autoinjector during drug delivery,

figure 7 shows two longitudinal sections of an autoinjector when the plug is located near the proximal end of the syringe,

figure 8 shows two longitudinal sections of an auto-injector when the body has moved in the distal direction relative to the frame after drug delivery,

figure 9 shows two longitudinal sections of the autoinjector when the needle is retracted to the safe position of the needle,

figure 10 shows schematic views of a locking mechanism for controlling the movement of media relative to the frame of the autoinjector in four different states,

figure 11 shows schematic views of a mechanism for controlling the extension of the needle to control the movement of the first sleeve in six different states,

12 shows schematic views of a syringe retraction control mechanism in three different states

13 shows schematic views of a feedback release mechanism to indicate the end of an injection in three different states,

Figure 14 shows schematic views of a plunger unlocking mechanism in three different states,

Figure 15 shows schematic views of a button unlocking mechanism in three different states,

figure 16 shows a perspective view of an alternative embodiment of a plunger unlocking mechanism,

17 shows a longitudinal section through an alternative embodiment of a button unlocking mechanism,

figure 18 shows longitudinal sections of an alternative embodiment of the fixation mechanism,

figure 19 shows a longitudinal section of a third embodiment of a locking mechanism,

figure 20 shows a longitudinal section of an alternative embodiment of a feedback unlocking mechanism,

21 is a longitudinal sectional view of an alternative embodiment of a needle extension control mechanism, also adapted to serve as a locking mechanism when retracting the needle and extending the needle,

figure 22 shows a perspective view of a mechanism for controlling the extension of the needle shown in figure 21,

23 shows longitudinal sections of a third embodiment of a needle extension control mechanism, also adapted to perform the functions of a locking mechanism,

figure 24 shows an isometric view of the mechanism for controlling the extension of the needle shown in figure 23,

25 shows longitudinal sections of a third embodiment of a feedback unlocking mechanism,

26 shows another embodiment of an auto-injector having a female trigger clutch instead of a trigger button,

figure 27 shows a longitudinal section of the distal end of the autoinjector with an alternative feedback unlocking mechanism before activation,

figure 28 shows a longitudinal section of the distal end of the auto-injector with the alternative feedback unlocking mechanism shown in Figure 27, after release.

Similar parts in all Figures are marked with the same reference numerals.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Inclined engagement in the present description should be understood as engagement between two components, in which at least one of them has an inclined element for engaging the other component so that one of the components bends to the side when the components axially exert pressure on each other, provided that this component is not devoid of the ability to bend to the side.

Figures 1A and 1B show two longitudinal sections of the autoinjector 1 in different section planes, while the section planes are rotated approximately 90 ° relative to each other, while the autoinjector 1 itself remains in its original state until the injection begins. The autoinjector 1 comprises a frame 2. In the following, the frame 2 is generally considered to be fixed in place, so that the movement of the other components is described relative to the frame 2. A syringe 3, for example a Hypak syringe having a hollow injection needle 4, is located in the proximal part of the autoinjector 1. When the autoinjector 1 or syringe 3 is assembled, a needle shield (not shown) is attached to the needle 4. The plug 6 is configured to seal the syringe 3 in the distal direction and move the drug M through the cannula 4. The syringe 3 is held in the tubular carrier 7 and is supported therein at its proximal end. The carrier 7 is located in the frame 2 with the possibility of sliding.

The drive spring 8 in the form of a compression spring is located in the distal part of the carrier 7. The plunger 9 serves to transfer the force of the drive spring 8 to the plug 6.

The drive spring 8 is loaded between the distal end surface 10 of the carrier 7 and the thrust surface 11 located distally on the plunger 9.

The carrier 7 is the main element in which the syringe 3, the drive spring 8 and the plunger 9 are placed, which are the components necessary for displacing the drug substance M from the syringe 3. These components can thus be called the drive subassembly.

The frame 2 and the carrier 7 are located in the tubular body 12. The start button 13 is located on the distal end of the housing 12. In the mechanism 27 for unlocking the plunger from the distal end surface of the start button 13, a pin 14 protrudes in the proximal direction P between two elastic consoles 15 formed and extending distally from the abutment surface 11 of the plunger 9 within the drive spring 8, thus preventing them from bending towards each other in the initial state A shown in Figure 14A. Figure 14A shows only one of the elastic arms 15 for explaining the principle. Outwardly, the elastic consoles 15 are gripped in the respective first recesses 16 in the distal sleeve 17 of the carrier, mounted distally to the distal end surface 10 of the carrier and located inside the drive spring 8. The engagement of the elastic consoles 15 in the first recesses 16 does not allow axial translational movement of the plunger 9 relative to the carrier 7. The elastic consoles 15 are equipped with an inclined element so as to bend inward with the relative movement of the plunger 9 and the carrier 7 under load from the side of the drive bar ins 8, which is not allowed pin 14 in the initial state A.

The carrier 7 is locked on the frame 2 to prevent relative translational movement using the locking mechanism 18, shown in more detail in figures 10A-10D.

The start button 13 initially engages with the housing 12 using the button release mechanism 26 and cannot be pressed. The button unlocking mechanism 26 is shown in detail in Figures 15A-15C. As shown in FIG. 15A, the button release mechanism 26 comprises an elastic proximal beam 13.1 on the start button 13, wherein the proximal beam 13.1 has an outer first inclined member 13.2 and an inner second inclined member 13.3. In the first state A, shown in Figure 15A, the inner second inclined element 13.3 engages with the inclined lock 7.4 of the carrier 7, preventing the start button 13 from moving beyond the distal end D. The start button 13 proximal rests on the housing 12 and / or the carrier 7 , which means it cannot be pressed in the proximal direction P.

As again shown in Figures 1A and 1B, an adjustment spring 19 in the form of another compression spring is located around the carrier 7 and operates between the proximal first sleeve 20 and the distal second sleeve 21. The adjustment spring 19 is used to move the carrier 7, and hence the drive subunit, in the proximal direction P to extend the needle or in the distal direction D to retract the needle. Prior to the onset of the state shown in Figures 1A and 1B, the cap 22 is secured to the proximal end of the housing 12, and the needle guard is still in place over the needle 4 and the needle hub. The inner shell 22.1 of the cap 22 is located inside the frame 2 on top of the protective cover of the needle. A hook 23 is fixed in the inner shell 22.1. The hook 23 is engaged with the needle shield for joint axial translational movement.

The sequence of operations of autoinjector 1 is as follows.

The user pulls the cap 22 from the proximal end of the housing 12. The hook 23 connects the needle shield to the cap 22. Therefore, the needle shield also is removed when cap 22 is removed. Figures 1A and 1B show auto-injector 1 when cap 22 and needle cover are removed. The carrier 7 and the syringe 3 are unable to move in the proximal direction P by the locking mechanism 18, which is in state A, shown in Figure 10A. As shown in FIG. 10A, the locking mechanism 18 comprises an elastic beam 2.1 on the frame 2 having a first beam head 2.2 protruding inwardly. The first beam head 2.2 has a proximal third inclined member 2.3. The fixing mechanism 18 further comprises a diamond-shaped inclined link 7.1 on the carrier 7 having a proximal fourth inclined element 7.2 and a distal fifth inclined element 7.3. In state A, the rounded distal side of the first head 2.2 of the beam abuts against the inclined link 7.1 in the distal direction D, resisting the movement of the carrier 7 in the proximal direction P relative to the frame 2. There is a rib on the housing 12 to prevent the external bending of the elastic beam 2.1, and therefore to prevent movement carrier 7 relative to the frame 2.

As again shown in figures 1A and 1B, the user grasps the housing 12 and has a frame 2 protruding from the housing 12 at the proximal end P, close to the injection site, for example, to human skin. When the auto-injector 1 is pressed close to the injection site, the housing 12 is translationally moving in the proximal direction P relative to the frame 2 to the extended position shown in figures 2A and 2B. The second sleeve 21 is fixed on the housing 12 and moves with the housing 12 relative to the frame 2, as well as relative to almost all other components of the autoinjector 1, thereby slightly pressing the adjustment spring 19 to the first sleeve 20, the movement of which in the proximal direction P is not allowed by the frame 2 due to that the needle extension adjustment mechanism 24 is in the state A shown in detail in FIG. 11A. As shown in FIG. 11A, an elastic link in the form of an arrowhead 20.1 is proximal to the first sleeve 20. The first sleeve 20, having the boom tip 20.1, is pushed in the proximal direction P under load from the side of the compressed adjusting spring 19. The outer sixth inclined element 20.2 on the boom tip 20.1 interacts with the second distal seventh inclined element 2.4 on the frame 2, tilting the boom tip 20.1 in the inner direction I, which is not allowed due to the fact that the boom tip 20.1 abuts inwardly against the carrier 7. Therefore, the first sleeve 20 cannot progressively move into the ideal direction P.

The arrowhead 20.1 of the arrow may have a different geometry than in figures 11A-11F, for example, a rounded arrowhead 20.1 of the arrow, as in figures 1-9. This option does not affect the operation of the boom tip 20.1.

As again shown in FIGS. 2A and 2B, the second sleeve 21 is fixed to the housing due to the fact that the syringe retraction control mechanism 25 is in state A, shown in detail in FIG. 12A. As shown in FIG. 12A, the syringe retraction control mechanism 25 comprises an elastic proximal beam 21.1 on the second sleeve 21, while the proximal beam 21.1 has a second head 21.2 having an inner protrusion 21.3 and a distal outer eighth inclined member 21.4. The distal outer eighth inclined member 21.4 is engaged with the inclined second housing retainer 12.2 so as to tilt the second beam head 21.1 in the inner direction I when the second sleeve 21 is under load from the control spring 19 in the distal direction D, which is not allowed that the inner protrusion 21.3 abuts inwardly against the carrier 7.

As again shown in FIGS. 2A and 2B, if the user moves the housing 12 away from the injection site, the adjustment spring 19 expands, returning the auto-injector 1 to its original state after removing the cap 22 shown in FIGS. 1A and 1B.

In the state shown in figures 2A and 2B, the carrier 7 is still unable to move in the proximal direction P by the locking mechanism 18, however, when the housing 12 is in its extended position, the locking mechanism 18 is unlocked, since the rib on the housing 12 has also moved more does not interfere with the external bending of the elastic beam 2.1. Moving the housing 12 relative to the carrier 7, which is locked on the frame 2 by the locking mechanism 18, causes the button unlocking mechanism 26 to switch to the intermediate state B shown in FIG. 15B. When the housing 12 is moved, the start button 13 continues to abut against the carrier 7, while the inner second inclined element 13.3 on the proximal beam 13.1 is engaged with the inclined retainer 7.4 of the carrier located on the carrier 7. When the housing 12 is progressively moved further in the proximal direction P, it serves as a support for the proximal beam 13.1 in the outward direction, thereby blocking the start button 13 on the carrier 7. The start button 13 now protrudes from the distal end D of the housing 12 and is ready to be pressed.

In the state shown in figures 2A and 2B, the user presses the start button 13 in the proximal direction P. Since the start button 13 abuts the carrier 7, the carrier 7 is pushed in the proximal direction P relative to the frame 2, while the carrier 7 and the frame 2 interact in the mechanism 18 fixation. The force exerted by the user pressing the start button 13 is distributed through the frame 2 to the injection site, and not between the start button 13 and the housing 12. The locking mechanism 18 creates a resistance force when the user pushes the start button 13. As soon as the user applies a force exceeding a predetermined value, the fixing mechanism 18 is released, starting the injection cycle. As shown in FIG. 10B, where the locking mechanism 18 in state B is shown, the elastic beam 2.1 on the frame 2 begins to bend under load from the diamond-shaped inclined link 7.1 on the carrier 7, storing the energy of elastic deformation. Despite the presence of the proximal fourth inclined element 7.2 on the inclined link 7.1, the friction between the contacting surfaces of the first head 2.2 of the beam and the proximal fourth inclined element 7.2 does not allow the first head 2.2 of the beam to move outward O until the rectifying force in the elastically deformed beam 2.1 becomes large enough to overcome it. At this point, the elastic beam 2.1 bends outwardly O, leaving the path of the carrier 7, thereby allowing the carrier 7 to move progressively in the proximal direction P. When the carrier 7 moves far enough in the proximal direction P, the diamond-shaped inclined link 7.1 on the carrier 7 passes under the first head 2.2 of the beam, thereby allowing it to relax and move backward in the inner direction I distally behind the diamond-shaped inclined link 7.1 in state C shown in Figure 10C, while at the same time holding the post additional movement of the carrier 7 in the distal direction D relative to the frame 2.

When the carrier 7 slides far enough in the proximal direction P relative to the first sleeve 20, the needle extension adjustment mechanism 24 switches to state B shown in FIG. 11B. In FIG. 11B, the carrier 7 is progressively moved in the proximal direction P so that the boom tip 20.1 on the first sleeve 20 is no longer supported in the inner direction. This can be achieved using the second recess 7.5 on the carrier 7. The boom tip 20.1 is now biased inwardly I to the second recess 7.5 under load from the side of the adjusting spring 19, turning into state C, shown in figure 11 C. The first sleeve 20 is now disconnected from frames 2. Instead, the boom tip 20.1 connects the first sleeve 20 to the carrier 7 using the ninth inner inclined member 20.3, engaged with the distal tenth inclined member 7.6 on the carrier 7 at the proximal end of the second recess 7.5. Therefore, the adjustment spring 19 continues to move the carrier 7 in the proximal direction P from now on. Meanwhile, as the user advances the needle 4 to part of its path, the adjustment spring 19 takes over the introduction before the needle 4 protrudes from the proximal end P. Thus, the user experiences the sensation of pressing a button rather than manually inserting the needle.

The locking mechanism 18 is designed for the user to apply force, not displacement. When the force exceeds the force required for switching the latch, the user will press the start button 13 fully, ensuring that the first sleeve 20 will always be in the switching state. If the user cannot pass the lock, the start button 13 returns to its “unused" state, ready for use, as shown in Figures 2A and 2B. This feature allows you to avoid being autoinjector 1 in an undefined state.

Figures 3A and 3B show the auto-injector 1 when the start button 13 is pressed sufficiently to connect the adjustment spring 19 to the carrier 7 and continue to move the carrier 7 forward, but still against the stop in the housing 12.

The carrier 7 connected to the first sleeve 20 translates in the proximal direction P, driven by the adjusting spring 19. Since the syringe 3 is made with the possibility of joint axial translational movement with the carrier 7, the syringe 3 and the needle 4 are also translationally moved, resulting in a needle 4 protrudes from the proximal end of P and is introduced into the injection site. The start button 13 returns to its initial position relative to the housing 12, as a result of which the proximal beam 13.1 bends in the outer direction O due to the fact that the inner second inclined element 13.3 engages with the inclined element in the carrier latch 7.4, which means that the proximal beam 13.1 deviates into the first latch 12.1 of the casing and is fixed to the casing 12, passing from the carrier 7. The carrier 7 is progressively moving further in the proximal direction P, avoiding the internal deviation of the proximal beam 13.1, t So that the outer first inclined element 13.2 cannot disengage from the first housing latch 12.1.

Just before the needle 4 reaches the full insertion depth, as shown in FIGS. 4A and 4B, the pin 14 on the start button 13 is removed from the space between the elastic consoles 15 on the carrier 7 sufficiently to provide internal bending of the elastic consoles 15. Therefore, the plunger unlocking mechanism 27 transitions to state B shown in FIG. 14B, in which the elastic arms 15 are no longer internally supported by the pin 14. Due to the inclined engagement of the elastic arms 15 in the first recess 16, they deflect are inwardly I under load by the driving spring 8, going into a state C, as shown in Figure 14C. Therefore, the plunger 9 is released from the carrier 7 and is driven in the proximal direction P by the drive spring 8, ready to displace the drug substance M. The force for removing the pin 14 from the space between the elastic consoles 15 is created by the adjustment spring 19, while the force required to deflect the elastic consoles 15 for disengagement with the carrier 7, is provided by a drive spring 8.

While the plunger 9 moves and eliminates the gap with the plug 6, the movement of the carrier 7 in the proximal direction P is completed by the adjustment spring 19 pushing the first sleeve 20. When the carrier 7 moves relative to the frame 2 in the process of extending the needle, the needle extension mechanism 24 enters the state D shown in figure 11D. Boom tip 20.1 has moved with carrier 7 and is still held inwardly deflected by frame 2, thereby preventing the first sleeve 20 from being disengaged from carrier 7. Boom tip 20.1 must be able to deflect in the outer direction O to allow retraction as it will shown below. In order to ensure external deflection, the boom tip 20.1 moves proximally beyond the portion of the frame 2 shown in Figures 11A to 11F next to the hole 2.5 in the frame 2. However, as long as the casing 12 remains pressed against the injection site and is unable to return in the distal direction D beyond the specified distance under load from the side of the adjustment spring 19, the boom tip 20.1 will be kept from deflecting outwardly O by the first rib 12.3 on the housing 12 (not shown in Figures 11A-11F, see Figures 4A-7A) during approximately Ora half its movement for the extension of the needle.

Needle 4 is now fully inserted into the injection site, as shown in figures 5A and 5B. The length of time between pressing the start button 13 and the complete introduction of the needle 4 is very short, however, at this time several mechanical operations are carried out. The depth of the needle extension is determined by the carrier 7 relative to the frame 2, but not relative to the body 12, so if the user pulls his hand away or cannot hold the auto-injector 1 firmly pressed against the skin, only the body 12 will move in the distal direction D, while the injection depth will remain constant . As soon as the plunger 9 eliminates the gap with the plug 6 under the force of the drive spring 8, the plug 6 is pushed in the proximal direction P within the syringe 3, moving the drug substance M through the needle 4.

Immediately before the completion of drug displacement, when the plug 6 has almost reached the bottom in the syringe 3, as shown in figures 6A and 6B, the feedback component 28 is released. The imposition of tolerances, mainly associated with the syringe 3, requires that the feedback is always released before the complete withdrawal of the drug substance. Otherwise, with certain combinations of parts, the feedback will not always be released. The feedback component 28 comprises an elongated portion 28.1 located between the elastic consoles 15 on the plunger 9, as well as a distal end section 28.2, which is capable of abutting against the proximal protrusion 14.1 on the pin 14 of the start button 13. The second elastic consoles 30 start from the plunger 9 and continue in the distal direction D. The feedback spring 29 is configured to bias the feedback component 28 in the distal direction D relative to the plunger 9 by abutting proximal to the rib on the plunger 9, a in the dist In the opposite direction, toward the distal end portion 28.2 of the feedback component 28.

It should be noted that the feedback component 28 for simplicity is not shown in figures 15A, 15B and 15C, since it does not affect the operation of the button unlocking mechanism 26. A feedback unlocking mechanism 31 for releasing a feedback component 28 is shown schematically in Figures 13A, 13B and 13C. As shown in FIG. 13A, the feedback unlocking mechanism 31 includes second elastic consoles 30. On each of the second elastic consoles 30 there is an inclined inner protrusion 30.1, which engages with the corresponding outer eleventh inclined element 28.3 on the elongated portion 28.1 of the feedback component 28 so that the second elastic cantilever 30 deviates outwardly O under load from the side of the feedback spring 29. In the initial state A of the feedback unlocking mechanism 31, the second elastic consoles 30 are not able to deviate outward due to the abutment in the carrier 7, thereby preventing the translational component 28 of the feedback relative to the plunger 9. Therefore, the feedback component 28 is moved together with the plunger 9 and remains in state A immediately until the drug is completely displaced by the plug 6, which has almost reached the bottom in the syringe 3, as shown in figures 6A and 6B. At this point, the plunger 9 has progressively moved in the proximal direction P relative to the carrier 7 to such an extent that the second elastic consoles 30 reach the hole 7.22 on the carrier 7, so that they no longer have an outward support from the side of the carrier 7. Feedback release mechanism 31 thus reached state B, which is shown in FIG. 13B. Due to the inclined engagement between the inclined inner protrusion 30.1 and the outer eleventh inclined element 28.3, the second elastic arm 30 bends outwardly under load from the side of the feedback spring 29, thereby disengaging the feedback component 28 from the plunger 9 and allowing the feedback component 28 to move distally direction D under the influence of the feedback spring 29 in the state C shown in figure 13C. Consequently, the feedback component 28 accelerates in the distal direction D, while the distal end portion 28.2 hits the proximal protrusion 14.1 of the pin 14 on the start button 13, generating acoustic and tactile feedback for the user, indicating that the delivery of the drug is almost over ( compare with figures 7A and 7B).

Figures 7A and 7B show the auto-injector 1 when the plug 6 has fully reached the bottom of the syringe 3.

As mentioned above, the user can allow the housing 12 to move a few millimeters in the distal direction D under the force of the adjusting spring 19, without affecting the position of the needle 4, as long as this movement is less than a predetermined distance. If the user wishes to end the injection at any time, he must allow the housing 12 to move in the distal direction D over this distance. Figures 8A and 8B show a car injector 1 with a protruding frame, for example, after lifting from the injection site, when the housing 12 has completely moved in the distal direction D, so that the frame 2 protrudes from the proximal end of the housing 12. As the housing 12 moves, the first sleeve 20 unlocks the carrier 7, and then the second sleeve 21 is released from the housing 12 and pulls the carrier 7 in the distal direction D. The sequence of this switching is fundamentally important, since the tap will not happen if both bushes 20, 21 are attached to the carrier 7 at the same time. This problem is solved by separating the switching of the bushings 20, 21 by substantially displacing the housing 12.

The switching of the first sleeve 20 is shown in Figures 11E and 11F. In figure 11E, the housing 12 was able to move in the distal direction D under load from the side of the adjustment spring 19, for example, in the process of removing the autoinjector 1 from the injection site. The first rib 12.3 (not shown, see figure 8A) is removed behind the arrowhead 20.1. The first sleeve 20 is still pushed in the proximal direction P by the adjusting spring 19. Due to the engagement of the ninth inner inclined element 20.3 on the boom tip 20.1 with the distal tenth inclined element 7.6 on the carrier 7, the boom tip 20.1 deviates outwardly O into the hole 2.5 of the frame 2 (shown in figures 11A-11F), while the mechanism 24 for adjusting the extension of the needle enters the state E shown in figure 11E, disconnecting the first sleeve 20 from the carrier 7 and fixing it on the frame 2.

As the housing 12 moves further in the distal direction D relative to the frame, for example when removed from the injection site, the syringe retraction control mechanism 25 changes from its state A (compare with Figure 12A) to state B shown in figure 12B. The housing 12 and the second sleeve 21, fixed on the housing 12, together move in the distal direction D, while the carrier 7 is held in place by the locking mechanism 18 in its state C, as described above (compare with figure 10C). Due to this movement, the inner protrusion 21.3 on the second head 21.2 of the proximal beam 21.1 on the second sleeve 21 no longer abuts inwardly against the carrier 7. Instead, the inner protrusion 21.3 deviates inwardly I to the third recess 7.7 on the carrier 7 due to the inclined engagement of the second head 21.1 beams with an inclined second housing lock 12.2 under load from the side of the adjusting spring 19. The mechanism 25 for regulating the discharge of the syringe, thus, goes into state C, shown in figure 12C, in which the second sleeve 21 is disconnected from the housing 12 and connected to the carrier 7. The locking mechanism 18 exerts a small braking force when moving the carrier 7 before the syringe retraction control mechanism 25 switches to state C because there is a small sliding friction force exerted by the second sleeve 21, pulling up the carrier 7 in the distal direction D with the translational movement of the housing 12 in the distal direction D, when the mechanism 24 for adjusting the extension of the needle is already transferred to the state E. If the carrier 7 moves too far in the distal direction D before the second sleeve 21 makes a switch, the housing 12 ends the movement before the inner protrusion 21.3 can deviate into the third recess 7.7, not allowing retraction.

Starting from position C of the locking mechanism 18 (compare with FIG. 10C), the carrier 7, and hence the diamond-shaped inclined link 7.1, translationally moves in the distal direction D under load from the side of the adjustment spring 19. Therefore, the distal fifth inclined element 7.3 of the diamond-shaped inclined link 7.1 engages with the proximal third inclined member 2.3 on the first head 2.2 of the elastic beam 2.1 to deflect the elastic beam 2.1 in the inner direction I. This creates a small braking force when moving the carrier 7, it is necessary mate to ensure that the second sleeve 21 is switched to the carrier 7. The elastic beam 2.1 and the diamond-shaped inclined link 7.1 are laterally shifted to allow the elastic beam 2.1 to pass without touching the diamond-shaped inclined link 7.1 as soon as the first head 2.2 of the beam is completely on the inside from the inclined link 7.1 in the state D shown in figure 10D.

The adjustment spring 19 is installed at its proximal end in the housing by the fact that the first sleeve 20 abuts the frame 2. The distal end of the adjustment spring 19 moves the second sleeve 21 in the distal direction D, capturing with it the carrier 7, and hence the syringe 3 with a needle 4, overcoming the action of the locking mechanism 18, as shown in FIG. 10D. It should be noted that the needle 4 is retracted by the auto-injector 1 as soon as the user allows the housing 12 to translate progressively far enough, as opposed to auto-injectors with a protective needle cover, requiring the user to remove the auto-injector from the injection site, thereby independently removing the needle from the skin to allow the protective cover the needles move forward.

It should be noted that before retraction, the length of the space between the rib on the plunger 9 and the distal end portion 28.2 of the feedback component 28, where the feedback spring 29 is installed, exceeds the free length of the feedback spring 29. This means that when the carrier 7 is retracted (i.e., the distance between the plunger 9 and the feedback component 28 is reduced), the feedback spring 29 does not require re-compression, and therefore does not create any braking force.

In order to prevent the rattling of the feedback component 28 at the end of the dose and before withdrawal, you can try to make the free length of the feedback spring 29 equal to the length of the space between the rib on the plunger 9 and the distal end portion 28.2 of the feedback component 28. In this case, in the process of retraction, the feedback spring 29 will require re-compression, which reduces the force that controls the final part of the retraction. However, the feedback spring 29 has a very low speed and is calculated to meet acceptable limits for reliable retraction.

The retraction is completed when the distal sleeve 21 meets the first rear stop 12.4 on the housing 12, as shown in figures 9A and 9B. The arrow tip 20.1 on the first sleeve 20 from the inside abuts against the carrier 7 in the state F shown in Figure 11F, which means that it cannot deviate in the inner direction I. The outer sixth inclined element 20.2 of the arrow tip 20.1 is engaged behind the first rib 12.3 on the housing 12, avoiding the repeated pushing of the housing 12 in the proximal direction P. Between the arrow tip 20.1 and the first rib 12.3, a gap can be created taking into account the tolerances.

The locking mechanism 18 returns to state A shown in FIG. 10A, blocking the carrier 7 in the same position with respect to the frame 2 as originally, but now it cannot be unlocked, since the housing 12 cannot move relative to the frame 2.

The mark 20.4 on the first sleeve 20 is now visible through the indicator window 32 in the housing 12, indicating that autoinjector 1 is used.

16 is a perspective view of an alternative embodiment of a plunger unlocking mechanism 27. The plunger unlocking mechanism 27 prevents the plunger 9 from moving in the proximal direction P relative to the carrier 7 until the carrier 7 moves in the proximal direction P to extend the needle. In contrast to the plunger unlocking mechanism 27 shown in FIG. 14, where the relative movement of the carrier 7 and the start button 13 is used to unlock the plunger 9, in the alternative embodiment shown in FIG. 16, the plunger 9 is unlocked by moving the carrier 7 relative to the second sleeve 21. In FIG. 16 shows the plunger unlock mechanism 27 before the plunger is unlocked. The second sleeve 21 is shown as transparent to facilitate understanding. The plunger 9 is pushed in the proximal direction P by the drive spring 8. For the plunger 9 to move forward, it must rotate around the twelfth inclined element 7.8 on the carrier 7. The inclined link 9.1 on the plunger 9 is adapted to engage with this twelfth inclined element 7.8. The rotation of the inclined link 9.1 is blocked by the inner longitudinal rib 21.5 on the second sleeve 21, made in the form of a slot in the longitudinal hole 7.9 on the carrier 7. The housing 12 and the second sleeve 21 remain in the same position, i.e. connected to each other for joint axial translational movement. When the start button 13 is pressed, the carrier 13 and the plunger 9, being part of the drive subassembly, move in the proximal direction P, first by pressing the start button 13, and then by the adjustment spring 19, which assumes this function through the first sleeve 20, as described above. After the carrier 7 moves far enough in the proximal direction P relative to the second sleeve 21, the inclined link 9.1 on the sleeve 9 is freed from the longitudinal rib 21.5 on the second sleeve 21 and can rotate behind the proximal end of the longitudinal rib 21.5 due to inclined engagement with the twelfth inclined element 7.8 under load from the side of the drive spring 8. Therefore, the drive spring 8 moves the plunger 9 in the proximal direction P to displace the drug substance M.

17 is a longitudinal sectional view of an alternative embodiment of a button unlocking mechanism 26. In contrast to the button unlocking mechanism 26 of FIG. 15, which makes the appearance of the start button 13 appear when there is skin contact by switching the base of the start button 13 between the carrier 7 and the housing 12, the button unlocking mechanism 26 shown in FIG. 17 starts with that the start button 13 is locked, but protrudes from the distal end of the housing 12. When the carrier 7 has moved in the distal direction D when the frame 2 is in contact with the skin, it is possible to press the start button 13 and activate Injector 1. This ensures consistent execution of actions.

In the embodiment shown in FIG. 17, the start button 13 has two proximal beams 13.1, each of which has an inclined outer protrusion 13.4. In the initial state shown in figure 17, the inclined outer protrusions 13.4 are engaged with the corresponding fourth recesses 12.5 in the housing 12. The disengagement of the inclined external protrusions 13.4 from the fourth recesses 12.5 is not allowed due to the support 7 supporting the proximal beams 13.1 in the inner direction , not allowing the proximal beams 13.1 to deviate inward. The inner protrusions 13.5 on the proximal beams 13.1 abut against the second rib 7.10 on the carrier 7, preventing further movement of the carrier 7 in the proximal direction P in the initial state. After the carrier 7 has moved in the distal direction D when the frame 2 is in contact with the skin, the first window 7.11 on the carrier 7 moves beyond the inner protrusion 13.5, allowing the proximal beams 13.1 to tilt inward when the button 13 is pressed due to their inclined engagement in the fourth recesses 12.5. Now, the proximal beams 13.1 in the outer direction abut against the housing 12 and remain engaged with the carrier 7 even when the needle 4 is retracted. The start button 13, therefore, does not return to its initial position, indicating that autoinjector 1 has been used.

Figures 18A and 18B show two longitudinal sections of an alternative embodiment of the locking mechanism 18. The locking mechanism 18 shown in FIGS. 10A-10D, which may be called a treadmill mechanism, since the first beam head 2.2 moves along the diamond-shaped inclined link 7.1, has many functions that control the movement of the carrier 7 relative to the frame 2. In an alternative fixing mechanism 18, shown in Figures 18A and 18B, use three clips 7.12, 7.13, 2.6 to create the same effect.

The first clamp 7.12 is located in the form of an outwardly biased elastic beam on the carrier 7, extending from the carrier 7 in the proximal direction P. The first clamp 7.12 is configured to prevent the movement of the carrier 7 before pressure is applied to the frame 2 or, more precisely, the housing 12 progressively moves in contact with skin. The first clamp 7.12 consists of two sections arranged in a row. The first section 7.14 does not allow the movement of the carrier 7 in the proximal direction P by abutting against the frame 2 in the recess. The second section 7.15 is located in the form of an outwardly projecting head of the clamp, capable of tilting inwardly with an inclined element 12.6 on the frame 12 to unlock the first clamp 7.12, and thus releasing the carrier 7 from the frame 2 when the housing 12 is translationally moving in the proximal direction P in contact with skin. A longitudinal groove 2.7 is located in frame 2 to allow the second section 7.15 to slide in the proximal direction P after the lock is released. A slight frictional force between the first clamp 7.12 and the frame 2 creates the braking force necessary to ensure retraction.

The second clamp 7.13 is located in the form of an elastic beam on the carrier 7, continuing in the distal direction D, which has a protruding outward third head 7.16 of the beam with a proximal inclined element. The third beam head 7.16 serves as a back stop in the third rib 2.9 on the frame 2, in order to prevent the carrier 7 from moving in the distal direction D from its initial position. The carrier 7 and the frame 2 are assembled with the second clamp 7.13 in this position until the syringe 3 is inserted into the carrier 7, which is facilitated by the proximal inclined element on the third beam head 7.16. The syringe 3 fixes the clamp in place by preventing inward deflection, thereby forming a fixed stop.

The third clamp 2.6 is an elastic beam on the frame 2. continuing in the distal direction D. The inclined fourth head 2.8 of the beam on the third clamp 2.6 is made with the possibility of internal engagement in the fifth recess 7.17 on the carrier 7. When the first clamp 7.12 is unlocked, the user can apply a load to the third terminal 2.6 by applying pressure to the carrier 7 in the proximal direction P by pressing the start button 13. The third terminal 2.6 is subjected to compression load, i.e. it bends outward and is sharply released due to its inclined engagement with the carrier 7, providing the function of the latch by analogy with that shown in figure 10B.

Figure 19 shows a longitudinal section of a third embodiment of a locking mechanism 18, which is a variation of the embodiment shown in Figures 18A and 18B. In this embodiment, the locking function of the third terminal 2.6 is added to the first terminal 7.12. The lock between the housing 12 and the carrier 7 is removed in the same way, however, the latch is created due to the fact that the first clamp 7.12 is deflected inwardly to the second level due to the fact that the frame 2 does not have a groove 2.7 for the second section 7.15. Instead, the second section 7.15, after being tilted inwardly by the tilting element 12.6 on the housing 12, should be further tilted inwardly inside the frame 2 when an axial load is applied between the frame 2 and the carrier 7, sharply disengaging them.

20 is a longitudinal sectional view of an alternative embodiment of feedback unlocking mechanism 31. In contrast to the feedback unlocking mechanism 31 shown in FIG. 13, where the feedback spring 29 operates between the plunger 9 and the feedback component 28, in the embodiment shown in FIG. 20, the feedback spring 29 acts between the housing 12 and the feedback component 28 . During needle extension, the feedback spring 29 is compressed as the feedback component 28 moves with the carrier 7 relative to the housing 12. When the feedback component 28 is released by the plunger 9 shortly before the dose is dispensed, the feedback component 28 moves in the distal direction D and collides with the start button 13. In contrast to Figure 13, the feedback spring 29 is not re-compressed in the process of retracting the needle, since it is installed in the housing 12, and not in the plunger 9.

Figures 21A and 21B show longitudinal sections of an alternative embodiment of the needle extension adjustment mechanism 24, which is also configured to engage the locking function of the locking mechanism 18 when the needle is retracted and the needle is extended. Figure 22 shows a corresponding isometric view. The fourth clamp 20.5 on the first sleeve 20 is in the form of an elastic beam having a beam head with an inner proximal thirteenth inclined element 20.6 for engagement with the fourth rib 7.18 on the carrier 7 and the outer housing supported 12 to hold the first sleeve 20 in mesh with the carrier 7 before use, in the process of extending the needle and in the process of displacing the drug substance. When the housing 12 moves distally with respect to the carrier, for example, when the user lifts the housing 12 from the injection site at the end of the injection, the sixth recess 12.7 in the housing 12 moves outwardly behind the fourth clamp 20.5, allowing the fourth clamp 20.5 to release when the carrier 7 is pulled in the distal direction D by the second sleeve 21. Since the fourth clamp 20.5 must be tilted outward, a small force is required to release the fourth clamp 20.5, which creates a latch during retraction.

Before use, the fifth clamp 2.10 on the frame 2 rests against the block 20.7 on the first sleeve 20, preventing the movement of the first sleeve 20, and hence the carrier 7, which is meshed with the first sleeve 20, in the proximal direction P. To unlock, the fifth clip 2.10 must deviate outward over the block 20.7. The outer bend of the fifth clamp 2.10 is initially not allowed by the housing 12. After the housing 12 has moved in contact with the skin, the second window 12.8 in the housing 12 appears in the outer direction from the fifth clamp 2.10, allowing an external bend. The fifth clip 2.10 is further deflected by the fourteenth inclined element 7.19 on the carrier 7 when the carrier 7 is pushed in the proximal direction P when the button is pressed, when the fourth clip 20.5 allows the progressive movement of the carrier 7 in the proximal direction P relative to the first sleeve 20, but nothing else. The latch for extending the needle is created by the need to displace the fifth clamp 2.10 when a load is applied to it from the side of the adjustment spring 19.

Figures 23A and 23B show longitudinal sections of a third embodiment of a needle extension adjustment mechanism 24, also adapted to perform the functions of the locking mechanism 18. Figure 24 shows an isometric view of the needle extension adjustment mechanism 24 shown in Figure 23. This embodiment is similar to the embodiment shown in Figures 21A, 21B and 22. The difference is that the fifth clip 2.10 is located on the first sleeve 20, and the unit 20.7 is located on frame 2, i.e. their places have changed, so that on the first sleeve 20 there are two clamps 2.10 and 20.5.

The fourth clip 20.5 is identical to the clip in Figure 21B. It stores the first sleeve 20 in connection with the carrier 7 until the needle retraction is started, ensuring the needle is reached and extended to the full length or depth until the retraction cycle is initiated by moving the case back in the distal direction relative to the frame, for example when removing the autoinjector 1 from the skin .

The fifth clamp 2.10 creates a latch for extending the needle and releases the first sleeve 20 from the frame 2, initiating the extension of the needle. The fifth clamp 2.10 does not allow the movement of the first sleeve 20, and therefore the carrier 7, which engages with the first sleeve 20, in the proximal direction P before using the device due to the stop in the block 20.7 on the frame 2. To unlock, the fifth clamp 2.10 must deviate outward over the block 20.7. The outer bend of the fifth clamp 2.10 is initially not allowed by the housing 12. After the housing 12 has moved in contact with the skin, the second window 12.8 in the housing 12 appears in the outer direction from the fifth clamp 2.10, allowing an external bend. The fifth clip 2.10 is further deflected by the fourteenth inclined element 7.19 on the carrier 7 when the carrier 7 is pushed in the proximal direction P when the button is pressed, when the fourth clip 20.5 allows the progressive movement of the carrier 7 in the proximal direction P relative to the first sleeve 20, but nothing else. The latch for extending the needle is created by the need to displace the fifth clamp 2.10 when a load is applied to it from the side of the adjustment spring 19.

Figures 25A and 25B show a longitudinal section through a third embodiment of a feedback unlocking mechanism 31. In this embodiment, a special feedback spring is not required. The plunger 9 contains a proximal inclined rib 9.2, configured to expand two seventh clips 7.21 on the carrier 7 immediately before completion of the dose. When the proximal inclined rib 9.2 moves beyond the seventh clips 7.21, they collapse back and collide with the plunger 9, causing a sound. The tubular shape of the carrier 7 promotes sound transmission. 25A shows a feedback unlocking mechanism 31 before release. 25B shows a feedback unlocking mechanism 31 after release. The proximal surfaces of the seventh clamps 7.21 on the carrier 7 are axially offset to facilitate assembly by alternately lifting the seventh clamps 7.21 above the distal side of the proximal inclined rib 9.2.

Figures 26A and 26B show longitudinal sections in another embodiment of the autoinjector 1 in different section planes, while the section planes are rotated approximately 90 ° relative to each other, while the autoinjector 1 itself remains in its original state until it is used. Autoinjector 1 is essentially identical to autoinjector in figures 1-15. However, unlike the auto-injector shown in figures 1-15, the auto-injector 1 according to this embodiment instead of a start button has a female starting clutch.

The female starter clutch 12 is the same component as the housing 12, which has a closed distal end surface 12.10 other than that shown in figures 1-15. The internal start button 13 is located at the distal end inside the start sleeve 12. In contrast to figures 1-15, the start button 13 is not visible and does not protrude from the housing 12 in any of the states. In the initial state, a gap 33 is provided between the distal end surface 12.10 of the start-up clutch 12 and the internal start-up button 13, allowing the start-up clutch 12 to make some movement without colliding with the start-up button 13.

Since autoinjector 1 is no different from the autoinjector shown in figures 1-15, in other aspects, it works essentially the same way, except for the following points.

When the frame 2 is placed close to the injection site, the starting sleeve 12 is translationally moving in the proximal direction P relative to the frame 2 to the extended position in the first stage of the movement of the sleeve, eliminating the gap 33 between the distal end surface 12.10 of the starting sleeve 12 and the internal starting button 13. As in the embodiment in figures 1-15, this movement unlocks the locking mechanism 18 and the start button 13. As the user continues to exert pressure on the start sleeve 12 in the second stage of movement of the sleeve, thereby further advancing it in the proximal direction P, the distal end surface 12.10 collides with the internal trigger button 13, thereby pressing it until the first sleeve 20 is released from the frame 2 and the force of the adjustment spring is applied to the carrier 7. The carrier 7 next advances until the internal start button 13 stops on another rib in the housing 12 and the plunger unlock mechanism 27 is unlocked (it should be noted that the pin 14 in this embodiment is shorter).

From the user's point of view, the locking mechanism 18 is configured to create a resistance force when the user reaches the second stage of movement of the coupling. From the point of view of the merits, at this point there is no difference from the implementation option presented in figures 1-15.

The extension of the needle is started due to the fact that the user fully advances the start-up clutch 12 in the second stage of movement of the clutch, thereby completely pushing the internal start-up button 13 and overcoming the locking mechanism, as in the embodiment shown in figures 1-15.

When the adjustment spring 19, upon pressing the button, assumes the function of fully moving the carrier 7 to extend the needle, the internal start button 13 reaches the inner fifth rib 12.11 in the start sleeve 12, while the internal start button 13 switches back to the locked position on the start sleeve 12, as in the third state shown in figure 15C.

The embodiment shown in figures 26A and 26B may also be combined with alternative elements illustrated in figures 16-25.

Figure 27 shows a longitudinal section of the distal end of the autoinjector 1 with an alternative feedback unlocking mechanism 31 before being activated in the first position. The plunger 9, designed to act on the syringe or plug (not shown), is held in the carrier 7 of the syringe. The start button 13 is located on top of the distal end of the syringe carrier 7. The drive spring 8 is located in the carrier 7, while distally mounted on the carrier 7, and proximally adjacent to the abutment surface 11 on the plunger 9. The distal clutch 17 of the plunger is mounted distally to the abutment surface 11 and is located inside the actuator spring 8. The feedback component 28 contains an elongated section 28.1 located in the distal sleeve 17 of the plunger, as well as the distal end pin 28.4, which is completely located in the carrier 7 in the first position, and therefore the user does not see and does not feel it.

The feedback spring 29 is configured to bias the feedback component 28 in the distal direction D relative to the plunger 9 due to the stop in the proximal direction against the abutment surface 11, and distally into the feedback component 28.

Both the drive spring 8 and the feedback spring 29 are in a stressed state. The plunger 9 engages with the carrier 7 using a plunger unlocking mechanism (not shown). The plunger unlock mechanism may be located in the same manner as in one of the above embodiments.

The distal clutch 17 of the plunger contains two elastic inclined grippers 17.1, holding the feedback component 28 by engagement with its inclined surface 28.5. Grips 17.1 from the outside are supported by a thickened section 7.23 of the wall of the carrier 7, so as to prevent them from deflecting in the outward direction by the action of the inclined element under conditions of applying a power load from the side of the feedback spring 29. Therefore, the feedback component 28 cannot be unlocked in this configuration.

Figure 28 shows a longitudinal section of the distal end of the auto-injector 1 with an alternative feedback unlocking mechanism 31 shown in Figure 27, after unlocking in the second position.

The plunger 9 is released by the plunger unlocking mechanism, which means that it has progressively moved in the proximal direction P to move the plug. During the proximal movement of the plunger 9, the inclined grips 17.1 on the distal sleeve 17 of the plunger left the thickened section 7.23 of the wall and entered the expanded section, allowing them to deviate outwardly under the action of the inclined element under load from the feedback spring 29. The feedback component moves in the distal direction D under the influence of the feedback spring 29 through the distal end of the carrier 7, as a result of which the distal end pin 28.4 protrudes from the distal end of the start button 13 through the through hole 13.7 located therein, when the feedback component 28 reaches second position. The distal end pin 28.4 is thus visible to the user. If the user still presses the trigger button 13 with his thumb, he can also feel with his thumb the distal end pin 28.4. In addition, the inclined surface 28.5, colliding with the start button 13 from the inside, can generate both a feedback sound signal and a tactile sensation of impact.

The distal clutch 17 of the plunger may have one or more elastic inclined grips 17.1. At least one elastic inclined grip 17.1 can also be connected directly to the abutment surface 11 on the plunger 9, so that the distal sleeve 17 of the plunger is not required.

The start button 13 can be connected to the carrier 7 or to a housing (not shown) surrounding the carrier 7. The start button 13 does not need to remain in the same longitudinal position relative to the carrier 7. Instead, at the end of the dose, the start button 13 can still located at the end of the housing (not shown), while the carrier 7 with all its internal components advanced in the housing. For this purpose, the feedback spring 29 and the feedback component 28 should be structurally powerful and long, respectively, to ensure that the feedback component 28 still reaches the trigger button 13 at the end of the dose delivery, so that the distal end pin 28.4 can protrude from the trigger buttons 13.

The feedback component 28 can be unlocked before the plunger 9 and the plug reach their end position for dispensing the dose, preferably shortly before this event.

The "noise" component 28 according to figures 27 and 28 can be combined with the embodiments shown in figures 1-26, while the corresponding trigger button 13 or female trigger coupling 12 should be equipped with a through hole 13.7, and the feedback component 28 should have a distal end pin 28.4. The unlocking of the feedback component 28 can be achieved either by the feedback unlocking mechanism 31 shown in Figures 27 and 28, or by one of the feedback unlocking mechanisms 31 illustrated in other embodiments.

The "noise" unlocking mechanism 31 according to Figures 27 and 28 can also be used in other types of autoinjectors. For example, the syringe carrier 7 may be used as part of a housing or housing instead of being housed in an additional housing. In the same way, the bore 13.7 can be located in the housing part or the female trigger sleeve instead of the trigger button 13.

The distal end pin 28.4 may have a color different from the color of the start button 13, for example red, to improve the visual indication notifying the user that the end of the dose has been reached and that the device has been used.

Of course, in all inclined engagement between the two components described in the above embodiments, there may be only one inclined element on one or another component, or inclined elements may be present on both components without significantly affecting the effect of inclined engagement.

The term “drug substance” as used herein means a pharmaceutical composition comprising at least one pharmaceutically active compound,

however, in one embodiment, the pharmaceutically active compound has a molecular weight of up to 1,500 Da and / or is a peptide, protein, polysaccharide, vaccine, DNA, RNA, enzyme, antibody or fragment thereof, a hormone or oligonucleotide, or a mixture of the aforementioned pharmaceutically active compounds,

in a further embodiment, the pharmaceutically active compound is useful for treating and / or preventing diabetes mellitus or complications associated with diabetes mellitus, such as diabetic retinopathy, thromboembolism complications such as deep vein thrombosis or pulmonary thromboembolism, acute coronary syndrome (ACS) , tonsillitis, myocardial infarction, malignant neoplasms, macular degeneration, inflammatory diseases, hay fever, atherosclerosis and / or rheumatoid arthritis,

however, in the following embodiment, the pharmaceutically active compound contains at least one peptide for treating and / or preventing diabetes mellitus or complications associated with diabetes mellitus, such as diabetic retinopathy,

in a further embodiment, the pharmaceutically active compound comprises at least one human insulin or a human insulin analog or derivative, glucagon-like peptide (GLP-1) or an analog or derivative thereof, or exedin-3, or exedin-4, or an analogue or a derivative of exedin-3 or exedin-4.

Insulin analogs can be, for example, Gly (A21), Arg (B31), Arg (B32) human insulin; Lys (B3); Glu (B29) human insulin; Lys (B28), Pro (B29) human insulin; Asp (B28) human insulin; human insulin, while the proline at position B28 is replaced by Asp, Lys, Leu, VaL or Ala, and at position B29 Lys can be replaced by Pro; Ala (B26) human insulin; Des (B28-B30) human insulin; Des (B27) human insulin and Des (B30) human insulin.

Derivatives of insulin can be, for example, B29-N-myristoyl des (B30) human insulin; B29-N-palmitoyl des (B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N- (N-palmitoyl-Y-glutamyl) des (B30) human insulin; B29-N- (N-lithocholyl-Y-glutamyl) des (B30) human insulin; B29-N- (ω-carboxyheptadecanoyl) des (B30) human insulin; and B29-N- (ω-carboxyheptadecanoyl) human insulin.

Exendin-4, for example, means Exedin-4 (1-39), the sequence of the peptides H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-GIn-Met-Glu- Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

Derivatives of Exedin-4, for example, are selected from the following list of compounds:

H- (Lys) 4-des Pro36, des Pro37 Exendin-4 (1-39) -NH2,

H- (Lys) 5-des Pro36, des Pro37 Exendin-4 (1-39) -NH2, des Pro36 [Asp28] Exendin-4 (1-39), des Pro36 [lsoAsp28] Exendin-4 (1-39) des Pro36 [Met (O) 14, Asp28] Exendin-4 (1-39), des Pro36 [Met (O) 14, lsoAsp28] Exendin-4 (1-39), des Pro36 [Trp (O2) 25, Asp28] Exendin-4 (1-39), des Pro36 [Trp (O2) 25, lsoAsp28] Exendin-4 (1-39), des Pro36 [Met (O) 14 Trp (O2) 25, Asp28] Exendin-4 (1-39), des Pro36 [Met (O) 14 Trp (O2) 25, lsoAsp28] Exendin-4 (1-39); or

des Pro36 [Asp28] Exendin-4 (1-39), des Pro36 [lsoAsp28] exendin-4 (1-39), des Pro36 [Met (O) 14, Asp28] Exendin-4 (1-39), des Pro36 [Met (O) 14, lsoAsp28] Exendin-4 (1-39), des Pro36 [Trp (O2) 25, Asp28] Exendin-4 (1-39), des Pro36 [Trp (O2) 25, lsoAsp28] Exendin -4 (1-39), des Pro36 [Met (O) 14 Trp (O2) 25, Asp28] Exendin-4 (1-39), des Pro36 [Met (O) 14 Trp (O2) 25, lsoAsp28] Exendin -4 (1-39), where the - Lys6-NH2 group may be bonded to the C-terminus of the Exendin-4 derivative;

or a derivative of Exendin-4 of the sequence H- (Lys) 6-des Pro36 [Asp28] Exendin-4 (1-39) -Lys6-NH2, des Asp28 Pro36, Pro37, Pro38 Exendin-4 (1-39) -NH2, H - (Lys) 6-des Pro36, Pro38 [Asp28] Exendin-4 (1-39) -NH2, H-Asn- (Glu) 5dez Pro36, Pro37, Pro38 [Asp28] Exendin-4 (1-39) -NH2 , des Pro36, Pro37, Pro38 [Asp28] Exendin-4 (1-39) - (Lys) 6-NH2, H- (Lys) 6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4 (1-39) - (Lys) 6-NH2, H-Asn- (Glu) 5-des Pro36, Pro37, Pro38 [Asp28] Exendin-4 (1-39) - (Lys) 6-NH2, H- (Lys) 6-des Pro36 [Trp (O2) 25, Asp28] Exendin-4 (1-39) -Lys6-NH2, Des Des28 Pro36, Pro37, Pro38 [Trp (O2) 25] Exendin-4 (1-39) -NH2, H- (Lys) 6-des Pro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin-4 (1-39) -NH2, H-Asn- (Glu) 5-des Pro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin-4 (1-39) -NH2, des Pro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin-4 (1-39) - (L ys) 6-NH2, H- (Lys) 6-des Pro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin-4 (1-39) - (Lys) 6-NH2, H-Asn- (Glu ) 5-des Pro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin-4 (1-39) - (Lys) 6-NH2, H- (Lys) 6-des Pro36 [Met (O) 14, Asp28] Exendin-4 (1-39) -Lys6-NH2, des Met (O) 14 Asp28 Pro36, Pro37, Pro38 Exendin-4 (1-39) -NH2, H- (Lys) 6-des Pro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin-4 (1-39) -NH2, H-Asn- (Glu) 5-des Pro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin-4 (1 -39) -NH2, des Pro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin-4 (1-39) - (Lys) 6-NH2, H- (Lys) 6-des Pro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin-4 (1-39) - (Lys) 6-NH2, H-Asn- (Glu) 5 des Pro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin- 4 (1-39) - (Lys) 6-NH2,

H-Lys6-des Pro36 [Met (O) 14, Trp (O2) 25, Asp28] Exendin-4 (1-39) -Lys6-NH2, H-des Asp28 Pro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25] Exendin-4 (1-39) -NH2, H- (Lys) 6-des Pro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin-4 (1-39) -NH2, H-Asn- (Glu) 5-des Pro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] Exendin-4 (1-39) -NH2,

des Pro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] Exendin-4 (1-39) - (Lys) 6-NH2,

H- (Lys) 6-des Pro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] Exendin-4 (S1-39) - (Lys) 6-NH2,

H-Asn- (Glu) 5-des Pro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] Exendin-4 (1-39) - (Lys) 6-NH2;

or a pharmaceutically acceptable salt or solvate of any of the aforementioned Exendin-4 derivatives.

Hormones are, for example, pituitary hormones or hypothalamic hormones, or regulatory active peptides and their antagonists according to the list in Rote Liste, ed. 2008, Chapter 50, such as gonadotropin (follitropin, lutropin, choriongonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserilin, nafarelin, goserelin.

The polysaccharide can be, for example, glucosaminoglycan, hyaluronic acid, heparin, low molecular weight heparin or ultra low molecular weight heparin, or derivatives thereof, or a sulfated, for example, polysulfated form of the above polysaccharides, and / or pharmaceutically acceptable salts thereof. Enoxaparin sodium is an example of a pharmaceutically acceptable salt of a polysulfated low molecular weight heparin.

Antibodies are globular plasma proteins (~ 150 kDa), which are also known as immunoglobulins with identical base structure. Having saccharide chains attached to amino acid residues, they are glycoproteins. The main functional unit of each antibody is an immunoglobulin monomer (lg) (containing only one lg unit); secreted antibodies can also be dimeric, having two lg units, such as lgA, tetrameric with four lg units, for example lgM of bony fishes, or pentamer with five lg units, for example mammalian lgM.

The monomer lg is a "Y" -shaped molecule consisting of four polypeptide chains; two identical heavy chains and two identical light chains connected by disulfide bonds between cysteine residues. The length of each heavy chain is about 440 amino acids; the length of each light chain is about 220 amino acids. Each of the heavy and light chains contains intrachain disulfide bonds stabilizing their folding. Each chain is formed by structural domains called lg domains. These domains contain about 70-110 amino acid residues and are divided into different categories (for example, variable, or V, and constant, or C) according to their size and functional purpose. They have a characteristic folding of the immunoglobulin chain, in which two β-sheets form a sandwich, held together by the interaction between cysteine and other charged amino acids.

Mammals have five lg heavy chains, designated α, δ, ε, γ, and μ. The type of heavy chain present determines the antibody isotype; these chains are found in LgA, LgD, LgE, LgG and LgM antibodies, respectively.

Distinguishable heavy chains differ in size and composition; α and γ contain approximately 450 amino acids, δ approximately 500 amino acids, while μ and ε have approximately 550 amino acids. Each heavy chain has two regions: a constant region (CH) and a variable region (VH). In one species, the constant region is essentially identical in all antibodies of the same isotype, but will be different in antibodies of other isotypes. The heavy chains γ, a, and δ have a constant region formed by three tandem Lg domains, as well as a hinge region that provides additional flexibility; the heavy chains μ and ε have a constant region formed by four immunoglobulin domains. The variable region of the heavy chain is different in antibodies produced by B cells, but the same in all antibodies produced by a single B cell or a B cell clone. The variable region of each heavy chain has a length of approximately 110 amino acid residues, and consists of one Lg domain.

In mammals, there are two types of immunoglobulin light chains, designated λ and κ. The light chain has two series-connected domains: one constant domain (CL) and one variable domain (VL). The approximate length of the light chain is from 211 to 217 amino acids. Each antibody contains two light chains that are always identical; mammals have only one type of light chain, κ or λ.

Although the overall structure of all antibodies is very similar, the individual properties of this antibody are determined by variable (V) regions, as explained in detail above. More specifically, the variable loops, three light (VL) chains and three on the heavy (VH) chains, are responsible for binding to the antigen, i.e. for antigenic specificity. These loops are called hypervariable regions (CDRs). Since the CDRs of both the VH and VL domains contribute to the antigen binding site, it is the combination of the heavy and light chains, and not one of them, that determines the final specificity of the antigen.

An “antibody fragment” contains at least one antigen-binding fragment according to the above definition, performing substantially the same function and exhibiting the same specificity as the entire antibody of which it is a fragment. Limited proteolytic cleavage by papain leads to the breakdown of the lg prototype into three fragments. Two identical amino terminal fragments, each of which contains one complete L chain and about half of the H chain, are antigen binding fragments (Fab). The third fragment, similar in size but containing carboxyl terminal halves of both heavy chains with their interchain disulfide bonds, is a crystallizable fragment (Fc). The Fc fragment contains carbohydrates, complement binding and FcB binding sites. Limited pepsin cleavage leads to the formation of a single F (ab ') 2 fragment containing Fab fragments and a hinge region, including an H-H interchain disulfide bond. Fragment F (ab ') 2 is a divalent antigen binding fragment. The disulfide bond F (ab ') 2 can be cleaved to obtain Fab'. In addition, the variable regions of the heavy and light chains can be combined to form a single chain variable fragment (scFv).

Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts. Acid addition salts are, for example, HCl or HBr salts. The main salts are, for example, salts having a cation selected from alkali cations, for example, Na + or K +, or Ca2 +, ammonium ion N + (R1) (R2) (R3) (R4), where R1-R4 independently from each other means hydrogen a substituted C1-C6 alkyl group, a substituted C2-C6 alkenyl group, a substituted C6-C10 aryl group, or a substituted C6-C10 heteroaryl group. Further examples of pharmaceutically acceptable salts are described in "Remington's Pharmaceutical Sciences" 17. ed. Alfonso R. Gennaro (Ed.), Mark Publishing Company, Easton, Pa., U.S.A., 1985 and the Encyclopedia of Pharmaceutical Technology.

Hydrates are an example of pharmaceutically acceptable solvates.

LIST OF REFERENCE POSITIONS

1 - autoinjector

2 - frame

2.1 - elastic beam

2.2 - the first beam head

2.3 - proximal third inclined element

2.4 - distal seventh inclined element

2.5 - hole

2.6 - third clamp

2.7 - groove

2.8 - the fourth head of the beam

2.9 - third rib

2.10 - fifth clamp

2.11 - sixth clamp

3 - syringe

4 - hollow injection needle

5 - needle guard

6 - cork

7 - carrier

7.1 - inclined link

7.2 - proximal fourth inclined element

7.3 - distal fifth inclined element

7.4 - media lock

7.5 - second recess

7.6 - distal tenth inclined element

7.7 - third recess

7.8 - twelfth inclined element

7.9 - longitudinal hole

7.10 - second rib

7.11 - first window

7.12 - first clamp

7.13 - second clamp

7.14 - first section

7.15 - second section

7.16 - third beam head

7.17 - fifth recess

7.18 - fourth rib

7.19 - fourteenth inclined element

7.20 - the fifteenth inclined element

7.21 - seventh clamps

7.22 - hole

7.23 - thickened wall section

8 - a driving spring

9 - plunger

9.1 - inclined link

9.2 - proximal inclined rib

10 - end surface of the carrier

11 - persistent surface

12 - case

12.1 - first housing lock

12.2 - second housing lock

12.3 - first rib

12.4 - the first back emphasis

12.5 - fourth recess

12.6 - inclined element

12.7 - sixth recess

12.8 - second window

12.9 - third window

12.10 - distal end surface

12.11 - fifth rib

13 - start button

13.1 - proximal beam

13.2 - the outer first inclined element

13.3 - inner second inclined element

13.4 - inclined outer ledge

13.5 - inner ledge

13.6 - the second back emphasis

13.7 - passage hole

14 - pin

14.1 - proximal protrusion

15 - elastic console

16 - first notch

17 - distal sleeve of the carrier

17.1 - elastic inclined capture

18 - locking mechanism

19 - an adjusting spring

20 - the first sleeve

20.1 - arrowhead

20.2 - outer sixth inclined element

20.3 - inner ninth inclined element

20.4 - tag

20.5 - fourth clamp

20.6 - inner proximal thirteenth inclined element

20.7 - block

20.8 - fifth clamp

21 - second sleeve

21.1 - proximal beam

21.2 - second beam head

21.3 - inner ledge

21.4 - distal outer eighth inclined element

21.5 - longitudinal rib

22 - cap

22.1 - the inner shell

23 - hook

24 - needle extension control mechanism

25 is a mechanism for regulating the discharge of the syringe

26 - button unlock mechanism

27 - plunger unlock mechanism

28 is a feedback component.

28.1 - elongated section

28.2 - distal end section

28.3 - outer eleventh inclined element

28.4 - distal end pin

28.5 - inclined surface

29 - feedback spring

30 - second elastic console

30.1 - inclined inner protrusion

31 - feedback unlocking mechanism

32 - indicator window

33 - clearance

D - distal end, distal direction

I - inner direction

M - drug substance

O - outer direction

P - proximal end, proximal direction.

Claims (14)

1. An injection device for administering a dose of a drug substance (M), comprising: a housing (12) having a proximal end and a distal end; a carrier (7) configured to accommodate a syringe (3); and start button (13), while in the first state, the start button (13) is connected to the housing (12) and / or the carrier (7) and abuts against the distal end of the housing (12), while in the intermediate state, the housing (12) moves proximally relative to the carrier (7) and the start button (13), and the start button (13) is engaged with the carrier (7), in this case, in the second state, the start button (13) and the carrier (7) move proximally relative to the housing (12), and the start button (13) disengages from the carrier (7) and engages with the housing (12). 2. An injection device according to claim 1, in which the start button (13) includes a deflectable beam (13.1) made with the possibility of engagement with the housing (12) and the carrier (7). 3. An injection device according to claim 2, wherein the housing (12) includes a housing lock (12.1) configured to engage the beam (13.1). 4. The injection device according to claim 3, in which the beam (13.1) includes a first inclined element (13.2) made with the possibility of engagement with the latch (12.1) of the housing. 5. An injection device according to claim 3, wherein the carrier (7) includes a carrier latch (7.4) configured to engage the beam (13.1). 6. The injection device according to claim 5, in which the beam (13.1) includes a second inclined element (13.3), made with the possibility of engagement with the holder of the carrier (7.4). 7. The injection device according to claim 5, in which in the first state the beam (13.1) engages with the retainer (12.1) of the housing and / or the retainer (7.4) of the carrier. 8. The injection device according to claim 3, in which in the second state the beam (13.1) engages with the latch (12.1) of the housing, and the beam (13.1) abuts against the carrier (7). 9. The injection device according to claim 5, in which in the intermediate state the beam (13.1) engages with the retainer (7.4) of the carrier, and the beam (13.1) abuts against the housing (12).

Images