TWI572385B - Auto-injector - Google Patents

Description

Autoinjector

The invention relates to an autoinjector for providing a dose of a medicament.

Providing an injection is a process that brings many risks and challenges to both the user and the medical care professional.

Injection devices (i.e., devices that can deliver medicament from a medicament container) can typically be of two types - a manual device and an automated device.

In manual devices - the user must provide mechanical kinetic energy to drive the liquid through the needle. This is typically in the form of a button/plunger that must be continuously pressed by the user during injection. This method will bring a lot of disadvantages to the user. If the user stops pressing the button/piston, the injection will also stop. This means that if the device is not properly used (ie, the plunger is not fully pressed to its end position), the user can only give an insufficient amount of medication. Especially if the patient is elderly or the hands and feet are not flexible, the injection force for the user may be too high.

The amount of extension of the button/plunger may be too large. Such a user may inconveniently touch a fully extended button. The combination of the injection force and the amount of button extension can cause a trembling/shock of the hand, with the result that the discomfort is increased as the inserted needle moves.

The purpose of the automatic injection device is to make the self-providing of the injection therapy easier for the patient. Treatments currently administered using self-administered injections include diabetes (insulin and newer GLP-1 drugs), migraine, hormonal therapy, anticoagulants, and the like.

Autoinjection is a device that completely or partially replaces the work involved in non-oral medications provided by standard syringes. These tasks may include removal of the protective syringe cap, insertion of the needle into the patient's skin, injection of the drug, removal of the needle, protection of the needle And avoid the use of the device. This overcomes the shortcomings of many manual devices. The possibility of injection force/button extension, hand shake, and delivery of incomplete doses is reduced. Triggering can be performed by a variety of means, such as a trigger button and a needle touch and its depth of injection action. The energy to deliver liquid in some devices is provided by a spring.

U.S. Patent Publication No. US 2002/0095120 A1 discloses an automatic injection device which automatically injects a previously measured amount of liquid drug when a force spring is released. The tension spring moves an ampoule and moves from a storage position to a deployed position when the injection needle is released. The contents of the ampoule are then expelled by applying a spring force to the piston in the interior of the ampoule. After the liquid drug is injected, the tension stored in the tension spring is released and the injection needle is automatically retracted to its original storage position.

High viscosity agents require high force to drain them through relatively thin injection needles. In order to get these forces you need a powerful drive spring. This can cause a large shock felt by the user when the needle is inserted into the skin, and causes a strong force felt by the user when the injection is triggered.

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

This object was achieved by an autoinjector according to item 1 of the scope of the patent application.

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

In the context of this specification, the term proximal refers to the direction that is directed to the patient during the injection, and the term distal refers to the opposite direction from the patient. The term "inwards" refers to the radial direction of the longitudinal axis of the autoinjector, but the term outward refers to the opposite direction of the radial direction from the longitudinal axis.

In an exemplary embodiment, an injection device that provides a dose of a medicament includes a housing having a proximal end and a distal end, a carrier for receiving a syringe, and a trigger button. In a first state, the trigger button is coupled to the housing and/or the carrier and abuts the distal end of the housing. In an intermediate state, the housing moves proximally relative to the carrier and the trigger button, and the trigger button engages Pieces. In a second state, the trigger button and the carrier move proximally relative to the housing and the trigger button disengages from the carrier and engages the housing.

In an exemplary embodiment, the trigger button includes a connector for engaging the housing and carrying The deflectable beam of the piece. The outer casing includes a housing stop for engaging the beam. The beam includes a first ramp for engaging the housing stop. The carrier includes a carrier stop for engaging the beam. The beam includes a second ramp for engaging the carrier stop. In the first state, the beam engages the housing stop and/or the carrier stop. In the second state, the beam engages the outer casing stop and the beam abuts the carrier. In the intermediate state, the beam engages the carrier stop and the beam abuts the outer casing.

Further areas of applicability of the present invention will become apparent from the Detailed Description. It is to be understood, however, that the invention may be in the There is no difficulty for those skilled in the art.

The present invention will be fully understood from the following detailed description and the accompanying drawings.

1‧‧‧Autoinjector

2‧‧‧Base

2.1‧‧‧Elastic beams

2.2‧‧‧First beam head

2.3‧‧‧near third slope

2.4‧‧‧ far seventh slope

2.5‧‧‧ hole

2.6‧‧‧ third clip

2.7‧‧‧Slit

2.8‧‧‧four beam head

2.9‧‧‧ Third rib

2.10‧‧‧ fifth folder

2.11‧‧‧ sixth clip

3‧‧‧Syringe

4‧‧‧ hollow injection needle

5‧‧‧Needle protection sheath

6‧‧‧stop

7‧‧‧Ship

7.1‧‧‧Slant

7.2‧‧‧ Near fourth slope

7.3‧‧‧ far fifth slope

7.4‧‧‧Load stop device

7.5‧‧‧Second recess

7.6‧‧‧ far tenth slope

7.7‧‧‧ Third recess

7.8‧‧‧ twelfth bevel

7.9‧‧‧ longitudinal holes

7.10‧‧‧second rib

7.11‧‧‧ first window

7.12‧‧‧First clip

7.13‧‧‧second clip

7.14‧‧‧ first paragraph

7.15‧‧‧ second paragraph

7.16‧‧‧ Third beam head

7.17‧‧‧ fifth recess

7.18‧‧‧4th rib

7.19‧‧‧fourteenth bevel

7.20‧‧‧ fifteenth bevel

7.21‧‧‧ seventh clip

7.22‧‧‧ hole

7.23‧‧‧Thickening the wall

8‧‧‧Drive spring

9‧‧‧Plunger

9.1‧‧‧Slant

9.2‧‧‧ Near-slope ribs

10‧‧‧ Carrier end face

11‧‧‧ thrust surface

12‧‧‧ Shell

12.2‧‧‧First outer casing stop

12.3‧‧‧Second outer casing stop

12.4‧‧‧First rib

12.5‧‧‧First backstop

12.6‧‧‧4th recess

12.7‧‧‧Slant parts

12.8‧‧‧ sixth recess

12.9‧‧‧Second window

12.10‧‧‧ third window

12.11‧‧‧ far end face

12.12‧‧‧ fifth rib

13‧‧‧ trigger button

13.4‧‧‧ 近梁

13.5‧‧‧ outward first slope

13.6‧‧‧Inward second bevel

13.7‧‧‧ obliquely facing outer boss

13.8‧‧‧Inwardly protruding

13.9‧‧‧second rear gear

13.7‧‧‧ hole

14‧‧‧ Studs

14.1‧‧‧Lost extensions

15‧‧‧Flexible arm

16‧‧‧First recess

17‧‧‧Right plunger sleeve

17.1‧‧‧Flexible bevel bolt

18‧‧‧stop mechanism

19‧‧‧Control spring

20‧‧‧First ring

20.1‧‧‧ arrow

20.2‧‧‧ outward sixth slope

20.3‧‧‧Inward ninth bevel

20.4‧‧‧ Label

20.5‧‧‧ fourth clip

20.6‧‧‧Inward near thirteenth bevel

20.7‧‧‧

20.8‧‧‧ fifth folder

21‧‧‧Second ring

21.1‧‧‧near beam

21.2‧‧‧Second beam head

21.3‧‧‧Inwardly protruding

21.4‧‧‧ far from the eighth slope

21.5‧‧‧ longitudinal ribs

22‧‧‧ cover

22.1‧‧‧Inner sleeve

23‧‧‧ Barb

24‧‧‧Needle extension control mechanism

25‧‧‧Symbolic return control mechanism

26‧‧‧ button release mechanism

27‧‧‧Plunger release mechanism

28‧‧‧Return component

28.1‧‧‧Elongation

28.2‧‧‧ far end

28.3‧‧‧ outward eleventh bevel

28.4‧‧‧ distal tip

28.5‧‧‧Bevel

29‧‧‧Feedback spring

30‧‧‧Second elastic beam

30.1‧‧‧ obliquely facing inner seat

31‧‧‧Feedback release mechanism

32‧‧‧ indicating window

33‧‧‧ gap

D‧‧‧ far end, far direction

I‧‧‧Inward direction

M‧‧‧ Pharmacy

O‧‧‧ outward direction

P‧‧‧ proximal and proximal directions

Figure 1 is a two longitudinal section of the autoinjector after removal of a cover and needle protection sheath; Figure 2 is a two longitudinal section of the autoinjector with the housing moving in a proximal direction relative to the base; Figure 3 shows a Two longitudinal sections of the autoinjector with the depressed trigger button; Figure 4 shows two longitudinal sections of the autoinjector during advancement of the needle; Figure 5 shows two longitudinal sections of the autoinjector with the needle in the extended proximal position; Figure 6 shows two longitudinal sections of the autoinjector during drug delivery; Figure 7 shows two longitudinal sections of the autoinjector with the stopper located near a proximal end of the syringe; Figure 8 shows two longitudinal sections of the autoinjector with the outer casing facing The base is moved in the distal end direction; FIG. 9 is a two longitudinal section showing the autoinjector with the needle retracting into the safe position of the needle; Figure 10 is a schematic view showing a stop mechanism for controlling movement of the housing relative to the base in four different states; Figure 11 is a schematic view showing a needle extension control mechanism for controlling six different Controlling the movement of a first collar in a state; Figure 12 is a schematic diagram showing a syringe retraction control mechanism in three different states; Figure 13 is a schematic diagram showing a feedback release mechanism in three different states Indicates the end of the injection; Figure 14 is a schematic view showing a plunger release mechanism in three different states; Figure 15 is a schematic view showing a button release mechanism in three different states; Figure 16 is a plunger release An isometric view of another embodiment of the mechanism; Figure 17 is a longitudinal section of another embodiment of the button release mechanism; Figure 18 is a longitudinal section showing another embodiment of the stop mechanism; Figure 19 is a stop A longitudinal section of a third embodiment of the mechanism; FIG. 20 is a longitudinal section of another embodiment of the feedback release mechanism; and FIG. 21 is a longitudinal section showing another embodiment of the needle extension control mechanism, which is also disposed to The function of the stop mechanism is performed when the head is retracted and the needle is extended; FIG. 22 is an isometric view of the needle extension control mechanism of FIG. 21; and FIG. 23 is a longitudinal section of a third embodiment of the needle extension control mechanism, which is also provided To perform the function of the stop mechanism; Fig. 24 is an isometric view of the needle extension control mechanism of Fig. 23; Fig. 25 is a longitudinal section of a third embodiment showing the feedback release mechanism; Fig. 26 is a sleeve having pleats Another embodiment of an autoinjector with a trigger instead of a trigger button; Figure 27 is a longitudinal section of the distal end of the autoinjector prior to triggering, with an alternative feedback release mechanism; and Figure 28 is an automatic after release a longitudinal section of the distal end of the syringe, It has the alternative feedback release mechanism of FIG.

The beveled joint in the terminology of the present specification is a joint between two elements, at least one of which has a bevel for engaging another element, and from this point of view, if one of the elements is not prevented from flexing sideways, when the elements are mutually Pushing axially, this component will flex sideways.

Figures 1a and 1b show two longitudinal sections of an autoinjector 1 in different cross-sectional planes, the different cross-sectional planes being at an angle of almost 90 degrees to each other, wherein the autoinjector 1 is in an initial state prior to initiation of injection. The autoinjector 1 includes a base 2, hereinafter, the base 2 is generally considered to be fixed in position, so movement of other components is described relative to the base 2. A syringe 3, for example, a Hypak syringe, has a hollow injection needle 4 disposed in the proximal portion of the autoinjector 1. When the autoinjector 1 or the syringe 3 is assembled, a needle guard sheath (not shown) is attached to the needle 4. The stopper 6 is designed to seal the distal end of the syringe 3 and move the medicament M through the hollow needle 4. The syringe 3 is held in a tubular carrier 7 and supported at its proximal end to the tubular carrier 7. The carrier 7 is slidably disposed in the base 2.

A drive spring 8 in the shape of a compression spring is disposed at a distal portion of the carrier 7. A plunger 9 is used to deliver the force of the drive spring to the stop 6.

The drive spring 8 is loaded between the distal end face 10 of the carrier 7 and a thrust face 11 provided at a distal position of the plunger 9.

The carrier 7 houses the key elements of the syringe 3, the drive spring 8 and the plunger 9, and the syringe 3, the drive spring 8 and the plunger 9 are necessary components for ejecting the medicament M from the syringe 3. These components can therefore be referred to as a drive subassembly.

The base 2 and the carrier 7 are disposed within a tubular housing 12. A trigger button 13 is provided at the distal end of the outer casing 12. In a plunger release mechanism 27, a peg 14 protrudes from a distal end face of the trigger button 13 in the proximal direction P from the two elastic forces originating from and extending distally from the thrust face 11 of the plunger 9 in the drive spring 8. The arms 15 are bent between each other to prevent them from being bent toward each other in the initial state A, which is shown in Fig. 14A. Only one of the resilient arms 15 is shown in Figure 14A to illustrate this principle. The resilient arms 15 are externally captured in a single first recess 16 of a distal carrier sleeve 17, which is attached to the distal end of the distal end face 10 of the distal carrier And disposed inside the drive spring 8. Engagement of the resilient arm 15 in the first recess 16 prevents axial displacement of the plunger 9 relative to the carrier 7. The resilient arm 15 is inclined in such a way that the elastic arm 15 is flexed inwardly during the relative movement between the plunger 9 and the carrier 7 under the load of the drive spring 8, which in the initial state A is by the stud 14 prevent.

The carrier 7 is locked to the base 2 by a stop mechanism 18 to prevent relative displacement, and the details of the stop mechanism 18 are illustrated in Figures 10A through 10D.

The trigger button 13 is initially engaged by the button release mechanism 26 to the outer casing 12 and cannot be depressed. The details of the button release mechanism 26 are illustrated in Figures 15A through 15C. Referring now to Figure 15A, the button release mechanism 26 includes an elastic proximal beam 13.1 on the trigger button 13, the proximal beam 13.1 having an outward first slope 13.2 and an inwardly Two slopes 13.3. In the initial state A illustrated in Fig. 15A, the inward second ramp 13.3 is engaged in a ramp carrier stop 7.4 of the carrier 7 to prevent the trigger button 13 from moving out of the distal end D. The trigger button 13 is in close proximity to both the outer casing 12 and the carrier 7, and is thus prevented from being depressed in the proximal direction P.

Referring again to FIGS. 1A and 1B, a control spring 19 in the shape of another compression spring is disposed about the carrier 7 and operates between a proximal first collar 20 and a distal second collar 21. The control spring 19 is used to move the carrier 7 and thus move the secondary combination in the proximal direction P to perform needle extension or to move the secondary combination in the distal direction D for needle retraction.

Prior to the state shown in Figures 1A and 1B, a cover 22 is attached to the proximal end of the outer casing 12 and the needle protection sheath 5 is still positioned over the needle 4 and the injection needle hub. An inner sleeve 22.1 of the cover 22 is disposed inside the base 2 and covers the needle protection sheath 5. A barb 23 is attached to the inner sleeve 22.1. The barbs 23 engage the needle guard sheath 5 for joint axial displacement.

The sequence of operation of the autoinjector 1 is as follows: A user pulls the cover 22 from the proximal end of the outer casing 12. The barb 23 couples the needle protection sheath 5 to the cover 22. Thus, the needle protection sheath 5 is also removed when the cover 22 is removed. Figures 1A and 1B show the autoinjector 1 with the cover 22 and the needle guard sheath removed. The carrier 7 and the syringe 3 are prevented from moving in the proximal direction P by the stopper mechanism 18 of a state A as shown in Fig. 10A. Referring now to Figure 10A, the stop mechanism 18 includes a resilient beam 2.1 on the base 2 having an inwardly projecting first beam head 2.2. First beam head 2.2 It has a proximal third slope 2.3. The stop mechanism 18 further includes a rhomboid ramp member 7.1 on the carrier member 7, the rhomboid ramp member 7.1 having a proximal fourth slope 7.2 and a distal fifth slope 7.3. In the state A, a rounded distal side of the first beam head 2.2 abuts the ramp member 7.1 in the distal direction D against the movement of the carrier 7 relative to the base 2 in the proximal direction P. A rib on the outer casing 12 is provided to prevent outward deflection of the resilient beam 2.1, thereby also preventing movement of the carrier 7 relative to the base 2.

Referring again to FIGS. 1A and 1B, the user grasps the outer casing 12 and holds the base 2 projecting from the outer casing 12 at the proximal end P against an injection site, such as the patient's skin. When the autoinjector 1 is pressed against the injection site, the outer casing 12 is moved in the proximal direction P relative to the base 2 into a forward position as shown in Figs. 2A and 2B. The second collar 21 is locked to the outer casing 12 and moves with the outer casing 12 relative to the base 2 and almost all other components relative to the autoinjector 1, thus slightly compressing the control spring 19 against the first collar 20, as explained in detail A needle extending control mechanism 24 in a state A in FIG. 11A is prevented from moving in the proximal direction P by the base 2. Referring now to Figure 11A, an elastic member in the shape of an arrow 20.1 is attached to the proximal end of the first collar 20. Under the load of the compressed control spring 19, the first collar 20 with arrow 20.1 is being applied in the proximal direction P. An outwardly facing sixth bevel 20.2 on arrow 20.1 acts against a second, distal seventh bevel 2.4 on base 2, tilting arrow 20.1 in an inward direction I, but being blocked inwardly against carrier 51 by arrow 20.1. Thus, the first collar 20 cannot be moved in the proximal direction P.

The arrow 20.1 can have a different geometry than in Figures 11A to 11F, such as the rounded arrow 20.1 in Figures 1-9. The function of arrow 20.1 is not affected by this change.

2A and 2B, the second collar 21 is locked to the outer casing 12 because of a syringe retraction control mechanism 25 in a state A detailed in FIG. 12A. Referring now to Figure 12A, the syringe retraction control mechanism 25 includes an elastic proximal beam 21.1 on the second collar 21, the proximal beam 21.1 has a second beam head 21.2, and the second beam head 21.2 has an inwardly facing projection 21.3 and A far position outwards from the eighth slope 21.4. The distally outwardly directed eighth bevel 21.4 is joined to a beveled second outer casing stop 12.2 in such a manner that the second beam head 21.1 and the second collar 21 are inclined inwardly under the load of the control spring 19 in the distal direction D The direction I is blocked by the inwardly facing 21.3 inwardly against the carrier 7.

2A and 2B, if the user wants to move the outer casing 12 away from the injection site, the control spring 19 expands after the cover 22 is removed, and the autoinjector 1 returns to the initial condition, as shown in FIGS. 1A and 1B.

In the state of Figures 2A and 2B, the carrier 7 continues to be prevented from moving in the proximal direction P by the stop mechanism 18, however, as the outer casing 12 is in front of it, when the ribs on the outer casing 12 have also moved and not The stop mechanism 18 is then unlocked when the outward deflection of the spring beam 2.1 is prevented. The carrier member 7 is locked to the base 2 by the stop mechanism 18, and movement of the outer casing 12 relative to the carrier member 7 causes the button release mechanism 28 to shift to an intermediate state B as shown in Fig. 15B. When the outer casing 12 is moved, the outer first bevel 13.2 on the proximal beam 13.1 is engaged in a bevel carrier stop 7.4 provided in the carrier 7 to hold the trigger button 13 against the carrier 7. When the outer casing 12 is further moved in the proximal direction P, it externally supports the proximal beam 13.1, thus locking the trigger button 13 to the carrier 7. The trigger button 13 now protrudes from the distal end D of the outer casing 12 and is ready to be pressed.

In the state of FIGS. 2A and 2B, the user presses the trigger button 13 in the proximal direction P. When the trigger button 13 abuts against the carrier 7, the carrier 7 is pushed against the base 2 in the proximal direction P. The carrier 7 and the base 2 interact in a stop mechanism 18. The force applied by the user pressing the trigger button 13 is brought to the injection site via the base 2 rather than between the trigger button 13 and the outer casing 12. When the user presses the trigger button 13, the stop mechanism 18 provides a resistance. Once the user applies a force that exceeds a predetermined value, the stop mechanism 18 is released, initiating the injection cycle. Referring now to Figure 10B, which shows the stop mechanism 18 in state B, under the load of the rhomboid ramp member 7.1 from the carrier 7, the spring beam 2.1 on the base 2 begins to flex, storing elastic energy. Regardless of the proximal fourth slope 7.2 on the ramp member 7.1, the friction between the contact surfaces of the first beam head 2.2 and the proximal fourth slope 7.2 prevents the first beam head 2.2 from moving in the outward direction O until the elastically deformed beam 2.1 The straightening force is large enough to overcome it. At this point, the spring beam 2.1 is deflected in the outward direction O to remove the path of the carrier 7, thus moving the carrier 7 in the proximal direction P. When the carrier 7 travels far enough in the proximal direction P, the rhomboid ramp member 7.1 on the carrier 7 passes under the first beam head 2.2, so that it relaxes and moves back in the inward direction I as shown in Fig. 10C. After the distal end of the rhomboid ramp member 7.1 in the illustrated state C, the displacement of the carrier 7 relative to the base 2 in the distal direction D is simultaneously limited.

Once the carrier 7 slides in the proximal direction P relative to the first collar 20 Far, the needle extension control mechanism 24 is switched to the state B as shown in Fig. 11B, in which the carrier 7 has been moved in the proximal direction P, to the extent that the arrow 20.1 on the first collar 20 No longer supported internally. This can be achieved by the second recess 7.5 in the carrier 7. Under the load of the control spring 19, the arrow 20.1 is now deflected in the inward direction I into the second recess 7.5 to a state C as shown in Figure 11C. The first set of rings 20 is now decoupled from the base 2. Instead, arrow 20.1 couples the first collar 20 to the carrier 7 by an inward ninth bevel 20.3 to engage a distal tenth ramp 7.6 on the carrier 7 at the proximal end of the second recess 7.5. Therefore, from this point on, the control spring 19 continues to move the carrier 7 in the proximal direction P. When the user advances a proportion of the stroke of the needle 4, the control spring 19 takes over the injection before the needle 4 protrudes from the proximal end P. Therefore, what the user is experiencing is pressing the button instead of manually inserting the needle.

The stop mechanism 18 relies on the user applying a force rather than a displacement. Once the applied force exceeds the force required to switch the stop, the user will fully press the trigger button 13 to ensure that the first collar 20 will switch frequently. If the user cannot overcome the stop means, as shown in Figures 2A and 2B, the trigger button 13 returns to its unused state and is ready for use. This feature prevents the autoinjector 1 from reaching an undefined state.

3A and 3B show the autoinjector 1 with its trigger button 13 depressed sufficiently to couple the control spring 19 to the carrier 7 and continue to move the carrier 7 forward, but still not against the outer casing 12.

The carrier 7 coupled to the first collar 20 is driven to move in the proximal direction P by the control spring 19. When the syringe 3 is arranged to be axially displaced in conjunction with the carrier 7, the syringe 3 and the needle 4 are also displaced, causing the needle 4 to protrude from the proximal end P and be inserted into the injection site. The trigger button 13 is returned to its starting position relative to the housing 12, whereby the proximal beam 13.1 is deflected in the outward direction O by the inwardly facing second ramp 13.3, engaging a bevel in the carrier stop 7.4, thus, near The bit beam 13.1 is deflected into the first outer casing stop 12.1 and latched from the carrier 7 to the outer casing 12. The carrier 7 is further moved in the proximal direction P, preventing the inward deflection of the proximal beam 13.1 such that the outward first bevel 13.2 cannot be disengaged from the first outer casing stop 12.1.

As shown in Figures 4A and 4B, immediately before the needle 4 reaches the entire depth of injection, the pegs 14 on the trigger button 13 are pulled out from between the resilient arms 15 on the carrier 7 enough to deflect the resilient arms 15 inwardly. Thus, the plunger release mechanism 27 reaches the state B as shown in FIG. 14B while the elastic arm 15 is no longer supported internally by the peg 14. Due to the oblique connection of the elastic arm 15 The first recess 16 is engaged and deflected under the load of the drive spring 8 to reach the state C as shown in Fig. 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 discharge the medicine M. The force that pulls the stud 14 between the resilient arms 15 is provided by the control spring 19 and the force required to deflect the resilient arm 15 out of engagement with the carrier 7 is provided by the drive spring 8.

When the plunger 9 moves and closes to the gap of the stopper 6, the movement of the carrier 7 in the proximal direction P is completed by the control spring 19 pushing the first collar 20. Since the carrier 7 moves with respect to the base 2 during the extension of the needle, the needle extension control mechanism 24 reaches the state D shown in Fig. 11D. The arrow 20.1 has moved with the carrier 7 and is still kept inwardly deflected by the base 2, thus preventing the first collar 20 from disengaging from the carrier 7. The arrow 20.1 must be able to deflect in the outward direction O and allow for retraction, which will be discussed below. To allow for outward deflection, the arrow 20.1 travels proximally beyond the partial base 2 as shown in Figures 11A through 11F, which is adjacent to a hole 2.5 in the base 2. However, during the second half of its needle extension action, as long as the outer casing 12 is being held against the injection site and does not retract in the distal direction D beyond the predefined distance under the load of the control spring 19, then The arrow 20.1 will be prevented from being deflected in the outward direction O by a first rib 12.3 on the outer casing 12 (not shown in Figures 11A to 11F, see Figures 4A to 7A).

As shown in Figures 5A and 5B, the needle 4 is now entirely inserted into the injection site. The time between when the trigger button 13 is pressed and when the needle 4 is fully inserted is short, however several mechanical operations occur during this time. The depth of extension of the needle is defined by the carrier 7 relative to the base 2 rather than to the outer casing 12, so if the user is afraid or unable to hold the autoinjector 1 against the skin, only the outer casing will move in the distal direction D and the depth of injection Keep it fixed.

Under the urging force of the drive spring 8, the plunger 9 is closed to the gap of the stopper 6, and the stopper 6 is pushed in the syringe 3 in the proximal direction P, and the medicament M is delivered through the needle 4.

As shown in Figs. 6A and 6B, a feedback member 28 is released immediately before the drug discharge end point and the stopper 6 has almost reached the bottom of the syringe 3. In particular, most of the accumulation due to the tolerance of the syringe 3 needs to be returned before the drug is completely discharged and must be often released. Otherwise, feedback should not be released often in some combination of parts. The feedback member 28 includes An elongated portion 28.1 disposed between the resilient arms 15 on the plunger 9 and a distal end portion 28.2 of a proximal extension portion 14.1 disposed on the peg 14 of the trigger button 13. The second second resilient arm 30 originates from the plunger 9 and extends in the distal direction D. A feedback spring 29 is provided to bias the feedback member 28 in the distal direction D relative to the plunger 9 by proximally pressing a rib on the plunger 9 and pressing the distal end 28.2 of the feedback member 28 distally. .

Note that the feedback member 28 is not clearly illustrated in Figures 15A, 15B and 15C because it does not affect the function of the button release mechanism 26. The feedback release mechanism 31 that releases the feedback member 28 is schematically illustrated in Figures 13A, 13B, and 13C. Referring now to Figure 13A, the feedback release mechanism 31 includes a second resilient arm 30. An obliquely facing inner protrusion 30.1 is disposed on each of the second resilient arms 30, and each of the second resilient arms 30 respectively engages an outward eleventh inclined surface 28.3 on the elongated portion 28.1 of the feedback member 28, in such a manner as to feed back Under the load of the spring 29, the second resilient arm 30 is deflected in the outward direction O. In an initial state A of the feedback release mechanism 31, the second resilient arm is prevented from deflecting outward by the external support of the carrier 7, thus preventing displacement of the feedback member 28 relative to the plunger 9. As shown in Figures 6A and 6B, the feedback member 28 moves with the plunger 9 and remains in the state A until immediately after the medicament is completely discharged plus the stopper 6 has almost reached the end of the syringe 3. At this point, the plunger 9 has been moved relative to the carrier 7 in the proximal direction P to such an extent that the second resilient arm 30 reaches a hole 7.22 in the carrier 7 so as to no longer be externally supported by the carrier 7. The feedback release mechanism 31 has thus reached the state B of Fig. 13B. Due to the bevel engagement between the obliquely facing inner boss 30.1 and the outward eleventh bevel 28.3, the second resilient arm 30 deflects outwardly under the load of the feedback spring 29, thus disengaging the feedback member 28 from the plunger 9 and is shown in Figure 13C. The feedback spring 29 in the illustrated state C is driven to move the feedback member 28 in the distal direction D. Thus, the feedback member 28 is accelerated in the distal direction D and the distal end portion 28.2 impinges on the proximal extension portion 14.1 of the peg 14 on the trigger button 13, producing an audible and tactile feedback to the user that the drug delivery is about to end. (Comparative Figures 7A and 7B).

7A and 7B show the autoinjector 1 whose stop 6 has reached the bottom of the syringe 3 completely.

As indicated above, as long as the movement of the outer casing 12 is less than a predetermined distance, the user can move the outer casing 12 a few millimeters in the distal direction without affecting the position of the needle 4 under the force of the control spring 16. If the user wishes to end the injection at any time, He must move the outer casing 12 in the distal direction D beyond this distance. 8A and 8B show the autoinjector 1 whose base is extended, for example, the autoinjector 1 is lifted from the injection site and the outer casing 12 is moved all the way to the distal direction D such that the base 2 protrudes from the proximal end of the outer casing 12. When the outer casing 12 is moved, the first collar 20 releases the carrier 7, and then the second collar 21 is released from the outer casing 12 and pulls the carrier 7 in the distal direction D. The order of this conversion is important because if the collars 20, 21 are attached to the carrier 7, the fallback will fail. By the significant displacement of the outer casing 12, the separation of the split collars 20, 21 can be overcome.

The transition of the first set of rings 20 is shown in Figures 11E and 11F. In FIG. 11E, for example, during the movement of the autoinjector 1 away from the injection site, the housing 12 has been allowed to move in the distal direction D under the load of the control spring 19. The first rib 12.3 (not shown, see Figure 8A) is removed outwardly from arrow 20.1. The first set of rings 20 is still being pushed in the proximal direction by the control spring 19. Since the inward ninth bevel 20.3 on arrow 20.1 engages the distal end tenth slant 7.6 on the carrier 7, the arrow 20.1 is deflected in the outward direction O into the aperture 2.5 of the base 2 (shown in Figures 11A to 11F). The needle extension mechanism 24 reaches the state E shown in FIG. 11E, decoupling the first collar 20 from the carrier 7 and latching it to the base 2.

For example, when disengaging from the injection portion, when the outer casing 12 is moving further in the distal direction D relative to the base, the syringe retraction control mechanism 25 transitions from its state A (see FIG. 12A) to the state B shown in FIG. 12B. . When the carrier 7 is properly secured by the stop mechanism 18 in its state C as described above (see FIG. 10C), the outer casing 12 and the second collar 21 locked to the outer casing 12 move in the distal direction D. Due to this movement, the inward projection 21.3 on the second beam head 21.2 of the proximal beam 21.1 on the second collar 21 no longer abuts against the carrier 7 inwards. Instead, since the second beam head 21.1 is beveled to the beveled second outer casing stop 12.2 under the load of the control spring 19, the inwardly protruding seat 21.3 is deflected in the inward direction I into the carrier 7 Three recesses 7.7. As the second collar 21 is decoupled from the outer casing 12 and coupled to the carrier 7, the syringe retracts control mechanism 25 and thus reaches state C as shown in Figure 12C. Because of the small sliding force, the stop mechanism 18 applies a small blocking force to the movement of the carrier 7 before the syringe retraction control mechanism 25 transitions to the state C, which is imparted by the second collar 21, When the needle extension control mechanism 24 has been shifted into the state E, the carrier 7 is pulled in the distal direction D as the outer casing 12 is displaced in the distal direction D. If the carrier 7 moves too far in the distal direction D before the second collar 21 is switched, the outer projection 21.3 can be deflected into the first Before the three recesses 7.7, the outer casing 12 travels to avoid the return.

Starting from the position C of the stop mechanism 18 (see Fig. 11C), the carrier 7 and thus the rhomboid ramp member 7.1 are moved in the distal direction D under the load of the control spring 19. Thus, the distal fifth bevel 7.3 of the rhomboid ramp member 7.1 engages the proximal third bevel 2.3 on the first beam head 2.2 of the spring beam 2.1, to some extent, the deflecting elastic beam 2.1 is in the inward direction I. This applies a small blocking force to the movement of the carrier 7 which needs to ensure that the second collar 21 is switched to the carrier 7. When the first beam head 2.2 is completely inward from the bevel member 7.1 in the state D shown in Fig. 10D, the elastic beam 2.1 and the rhomboid bevel member 7.1 are biased to the side so that the elastic beam 2.1 passes without touching the rhomboid bevel Item 7.1.

With the first collar 20 abutting the base 2, the control spring 19 is grounded in the housing 12 at its proximal end. As shown in Fig. 10D, the distal end of the control spring 19 moves the second collar 21 in the distal direction D, and the carrier 7 and thus the syringe 3 having the needle 4 move therewith and overcome the stop mechanism 18. Note: With respect to the autoinjector with the needle cover, the needle 4 is withdrawn from the skin by the autoinjector 1 as soon as the user has displaced the outer casing 12 far enough, the autoinjector with the needle cover needs to be automatically removed from the injection site by the user. The syringe, by which he pulls the needle from the skin to advance the needle shield.

Note that the space between the rib on the plunger 9 and the distal end 28.2 of the feedback member 28, i.e., the feedback spring 29 is grounded, is greater than the free length of the feedback spring 29 prior to retraction. This means that when the carrier 7 is retracted (i.e., the distance between the plunger 9 and the feedback member 28 is reduced), the feedback spring 29 does not need to be re-squeezed and thus does not provide any blocking force.

To prevent the feedback member 28 from making an audible sound at the end of the dose and before retracting, it is contemplated that the free length of the feedback spring 29 is equal to the space between the rib on the plunger 9 and the distal end 28.2 of the feedback member 29. In this case, during the retraction, the feedback spring 29 should have to be compressed again, reducing the force that drives the last portion of the retraction. However, the feedback spring 29 is very low speed and has been calculated to be within acceptable tolerance limits for reliable retraction.

As shown in Figures 9A and 9B, when the distal collar 21 hits the first rear gear 12.4 on the outer casing 12, the retraction ends. The arrow 20.1 on the first set of rings 20 is internally supported by the carrier 7 in the state F shown in Fig. 11F and is thus prevented from being deflected in the inward direction I. The outward sixth bevel 20.2 of the arrow 20.1 is joined to the first rib 12.3 on the outer casing 12 to prevent external The shell is then pushed in the proximal direction P. A clearance can be provided between the arrow 20.1 and the first rib 12.3 to allow for tolerance.

The stop mechanism 18 returns to the state A as in Fig. 10A, as it initially locks the carrier 7 relative to the base 2, however, the outer casing 12 cannot move relative to the base 2, i.e. it cannot now be unlocked.

The label 20.4 on the first set of rings 20 can be seen through the indicator window 32 in the outer casing 12 indicating that the autoinjector 1 has been used.

Figure 16 is an isometric view of another embodiment of a plunger release mechanism 27. The plunger release mechanism 27 prevents the plunger 9 from moving relative to the carrier 7 in the proximal direction P until the carrier 7 moves in the proximal direction P for needle extension, relative to the plunger release mechanism 27 of FIG. The relative movement of the trigger button 13 and the trigger button 13 is used to trigger the release of the plunger 9, and another embodiment of Fig. 16 releases the plunger 9 by the movement of the carrier 7 relative to the second collar 21. Figure 16 shows the plunger release mechanism 27 before the plunger is released. The second collar 21 is shown as transparent to enhance clarity. The plunger 9 is being pushed in the proximal direction P by the drive spring 8. In order for the plunger 9 to advance, it must rotate about a twelfth bevel 7.8 on the carrier 7. A bevel member 9.1 on the plunger 9 is provided to engage the twelfth bevel 7.8. The rotation of the ramp member 9.1 is blocked by the inward longitudinal ribs 21.5 on the second collar 21 which are formed by providing a key strip in the longitudinal bore 7.9 in the carrier member 7. The outer casing 12 and the second collar 21 are maintained in the same position, i.e., coupled to each other for joint axial displacement. As described above, when the trigger button 13 is depressed, a portion of the carrier 7 and the plunger 9 that drive the secondary assembly are moved in the proximal direction P, first being depressed by the user by the trigger button 13, and then via the first collar. 20 is taken over by the control spring 19. Once the carrier 7 has moved far enough relative to the second collar 21 in the proximal direction P, the bevel 12 of the collar 9 engages the twelfth bevel 7.8 on the collar 9 due to the bevel on the collar 9 under the load of the drive spring 8 The ramp member 9.1 releases the restraint of the longitudinal rib 21.5 on the second collar 2.1 and is rotatable through the proximal end of the longitudinal rib 21.5. Therefore, the drive spring 8 advances the plunger 9 in the proximal direction P to discharge the medicament M.

17 is a longitudinal section of another embodiment of the button release mechanism 26. Unlike the button release mechanism 26 of FIG. 15, the grounding of the trigger button 13 is applied to the trigger button 13 when the skin is contacted between the carrier 7 and the outer casing 12, and the button release mechanism 26 of FIG. 17 is used as the trigger button 13. It is locked but protrudes from the distal end of the outer casing 12. Once the carrier 7 has moved in the distal direction D when the base is in contact with the skin, it is possible to press the trigger button 13 and activate the autoinjector 1. This ensures a sequential operation.

In the embodiment of Figure 17, the trigger button 13 has two proximal beams 13.1, each of which has a beveled outer projection 13.4. In the initial state shown in Fig. 17, the obliquely facing outer bosses 13.4 are respectively engaged in the fourth recesses 12.5 in the outer casing 12. The support member 7 internally supports the proximal beam 13.1 to prevent the obliquely facing outer projection 13.4 from being disengaged from the fourth recess 12.5, in such a manner as to prevent the proximal beam 13.1 from deflecting inwardly. The inward projection 13.5 on the proximal beam 13.1 abuts a second rib 7.10 on the carrier 7, in such a way as to prevent the carrier 7 from moving further in the proximal direction P in the initial state. Once the carrier 7 has moved in the distal direction D when the base 2 contacts the skin, a first window 7.11 in the carrier 7 is moved behind the inward projection 13.5 so that the proximal beam 13.1 is due to the pressing of the trigger button 13. Engaging the bevel into the fourth recess 12.5 deflects the proximal beam 13.1 inwardly. The proximal beam 13.1 is now supported externally by the outer casing 12 and remains engaged with the carrier 7 even when the needle 4 is retracted. Therefore, the trigger button 13 does not return to its starting position, indicating that the autoinjector 1 has been used.

18A and 18B show two longitudinal sections of another embodiment of the stop mechanism 18. The stop mechanism 18 of Figures 10A through 10D has multiple functions of controlling the movement of the carrier 7 relative to the base 2, as the first beam head 2.2 travels around the rhomboid ramp member 7.1 so it can be considered a "runway" mechanism. The other stop mechanism 18 of Figures 18A and 18B uses three clips 7.12, 7.13, 2.6 to produce the same effect.

The first clamp 7.12 is arranged as an outwardly biased elastic beam on the carrier 7, which extends from the carrier 7 in the proximal direction P. The first clip 7.12 is arranged to prevent the carrier 7 from being moved in the proximal direction P before the base 2 is depressed or more precisely the outer casing 12 is displaced. The first clip 7.12 consists of two sections side by side. A first segment 7.14 prevents movement of the carrier 7 in the proximal direction P by abutting the base 2 in the recess. A second segment 7.15 is configured as an outwardly projecting collet that is configured to be angled inwardly by the bevel member 12.6 on the base 12 for releasing the first clip 7.12 whereby the outer casing 12 is contacted when in contact with the skin When the shift is in the proximal direction P, the carrier 7 is unlocked from the base 2. The longitudinal slit 2.7 in the base 2 is arranged to slide the second section 7.15 in the proximal direction P once this locked state has been released. The slight friction between the first clamp 7.12 and the base 2 provides a retarding force to ensure retraction.

The second clip 7.13 is set as an elastic beam on the carrier 7, extending far away The bit direction D has a third beam head 7.16 that protrudes outward and has a proximal slope. The third beam head 7.16 acts as a rear stop against the third rib 2.9 on the base 2 for preventing the carrier 7 from moving from its starting position in the distal direction D. The carrier 7 and the base 2 and the second clamp 7.13 are combined at this position before the insertion of the syringe 3 into the carrier 7, and the insertion of the syringe 3 into the carrier 7 is facilitated by the proximal bevel on the third beam head 7.16. . The syringe 3 locks the clip in position by preventing inward deflection, thus creating a fixed stop.

The third clip 2.6 is an elastic beam on the base 2 extending in the distal direction D. A beveled fourth beam head 2.8 on the third clamp 2.6 is configured to be inwardly coupled to one of the fifth recesses 7.17 of the carrier 7. Once the first clip 7.12 is unlocked, the user can load the third clip 2.6 by pressing the carrier 7 in the proximal direction P when the trigger button 13 is depressed. The third clamp 2.6 is loaded during compression, i.e., because it ramps the carrier 7, it will bend outward and suddenly release, providing a stop function similar to that shown in Figure 10B.

Figure 19 is a longitudinal section of a third embodiment of the stop mechanism 18, which is a variation of the embodiment of Figures 18A and 18B. In this embodiment the stop function of the third clamp 2.6 has been added to the first clamp 7.12. The locking between the outer casing 12 and the carrier 7 is released in the same manner, but the stopping device is provided by a second step inward by deflecting the first clamp 7.12, which is achieved by the base 2 The second section of the 7.15 slit 2.7. Instead, the second section 7.15, once tilted inwardly by the ramp member 12.6 on the outer casing 12, must be further inclined inwardly into the interior of the base 2 during axial loading between the base 2 and the carrier 7, abruptly releasing their engagement.

Figure 20 is a longitudinal section of another embodiment of the feedback release mechanism 31. With respect to the feedback release mechanism 31 of FIG. 13, wherein the feedback spring 29 acts between the plunger 9 and the feedback member 28, in the embodiment illustrated in FIG. 20, the feedback spring 29 acts between the outer casing 12 and the feedback member 28. During the extension of the needle, when the feedback member 28 moves with the carrier 7 relative to the housing 12, the feedback spring 29 is compressed. When the feedback member 28 is released by the plunger 9 a little before the end of the dose, the feedback member 28 moves in the distal direction D and strikes the trigger button 13. Unlike FIG. 13, since the feedback spring 29 is grounded in the housing 12 instead of the plunger 9, the feedback spring 29 is not recompressed during the retraction of the needle.

21A and 21B show a longitudinal section of another embodiment of the needle extension control mechanism 24 that is also configured to perform the stop mechanism 18 when the needle is retracted and the needle is extended. Dynamic function. Figure 22 shows a related isometric view. A fourth clamp 20.5 on the first collar 20 is configured as an elastic beam having a beam head having an inwardly proximal thirteenth bevel 20.6 for engaging a fourth rib on the carrier 7. 7.18 and supported externally by the outer casing 12 to retain the first collar 20 in engagement with the carrier 7 prior to use during needle extension and medicament ejection. When the outer casing 12 is moved in the distal direction relative to the carrier, for example, when the user lifts the outer casing 12 away from the injection site at the end of the injection, a sixth recess 12.7 in the outer casing 12 is moved outward to the fourth clamp 20.5. Later, when the carrier 7 is pulled by the second collar 21 in the distal direction D, the fourth clamp 20.5 is released. Because the fourth clamp 20.5 must be tilted outward, a small force is required to release the fourth clamp 20.5, providing a retraction stop.

Before use, a fifth clip 2.10 on the base 2 abuts the square 20.7 on the first collar 20 to prevent the first collar 20 and thus the carrier 7 engaged with the first collar 20 from moving in the proximal direction P. . For release, the fifth clamp 2.10 must be deflected outward and past block 20.7. The outward deflection of the fifth clamp 2.10 is initially prevented by the outer casing 12. Once the outer casing 12 has moved upon skin contact, a second window 12.8 in the outer casing 12 emerges outwardly from the fifth clamp 2.10, allowing the fifth clamp 2.10 to deflect outwardly. Since the fourth clamp 20.5 does allow the displacement of the carrier 7 in the proximal direction P relative to the first collar 20 but not the opposite, when the carrier 7 is pushed in the proximal direction P when the button is depressed, the fifth clamp 2.10 is deflected by a fourteenth bevel 7.19 on the carrier 7. The fifth clamp 2.10 must be deflected when the fifth clamp 2.10 is loaded by the control spring 19 to provide a stop for the needle extension.

23A and 23B show a longitudinal section of a third embodiment of the needle extension control mechanism 24, which is also configured to perform the function of the stop mechanism 18. Figure 24 is an isometric view of the needle extension control mechanism 24 of Figure 23. This embodiment is similar to that illustrated in Figures 21A, 21B and 22, with the difference that the fifth clip 2.10 is attached to the first collar 20 and the block 20.7 is attached to the base 2, i.e., their positions have been converted. So there are two clips 2.10 and 20.5 on the first set of rings 20.

The fourth clip 20.5 is identical to FIG. 21B. Until the needle retraction is triggered, it maintains the first collar 20 attached to the carrier 7, ensuring that the entire extension or depth is reached and maintained until the retraction cycle is moved backwards in the distal direction relative to the base (eg, when from the skin) Start when the autoinjector 1 is removed.

The fifth clamp 2.10 provides a needle extension stop and is released from the base 2 The first set of rings 20 initiates the needle extension. The first collar 20 and thus the carrier 7 engaged with the first collar 20 are prevented from moving in the proximal direction P by abutting the fifth clamp 2.10 on the base 2 against the second clamp 2.10. For release, the fifth clamp 2.10 must be deflected outward and past the block 20.7. The outward deflection of the fifth clamp 2.10 is initially blocked by the outer casing 12. Once the outer casing 12 has moved upon skin contact, the second window 12.8 in the outer casing 12 emerges outwardly from the fifth clamp 2, allowing for outward deflection. Since the fourth clamp 20.5 does allow the displacement of the carrier 7 in the proximal direction P relative to the first collar 20 but not the opposite, when the carrier 7 is pushed in the proximal direction P when the button is depressed, the fifth clamp 2.10 is deflected by a fourteenth bevel 7.19 on the carrier 7. The fifth clamp 2.10 must be deflected when the fifth clamp 2.10 is loaded by the control spring 19 to provide a stop for the needle extension.

25A and 25B show a longitudinal section of a third embodiment of the feedback release mechanism 31. This embodiment can work without a dedicated feedback spring. The plunger 9 includes a proximal bevel rib 9.2 that is configured to open the second seventh clip 7.21 on the carrier 7 immediately before the end of the dose. When the proximal bevel ribs 9.2 have traveled past the seventh clamp 7.21, they bounce back and strike the plunger 9 to produce an acoustic. The tube shape of the carrier 7 helps to transmit a sound. Fig. 25A shows the feedback release mechanism 31 before release. Fig. 25B shows the feedback release mechanism 31 after release. By lifting the seventh clip 7.21 beyond the distal side of the proximal bevel rib 9.2 one by one, the proximal face of the seventh clip 7.21 on the carrier 7 is axially offset for ease of assembly.

Figures 26A and 26B show longitudinal sections of another embodiment of the autoinjector 1 in different cross-sectional planes, the different cross-sectional planes being at an angle of about 90 degrees, wherein the autoinjector 1 is in the initial state prior to initiating the injection. The autoinjector 1 is substantially identical to the autoinjector described in Figures 1 to 15. However, unlike the autoinjector of Figures 1 to 15, the autoinjector 1 of the present embodiment has a pleated sleeve trigger instead of a trigger button.

The pleated sleeve trigger 12 is a member identical to the outer casing 12 having a closed distal end face 12.10 instead of the ones of Figures 1-15. An internal trigger button 13 is disposed at the distal end within the sleeve trigger 12. Unlike the trigger buttons 13 of Figures 1 through 15, the buttons 13 are not visible and do not protrude from the housing 12 in any state. In the initial state a gap 33 is provided between the distal end face 12.10 of the sleeve trigger 12 and the trigger button 13, allowing some stroke of the sleeve trigger 12 without disturbing the trigger button 13.

Since in other respects the autoinjector 1 is different from the autoinjector of Figures 1 to 15, it operates substantially in the same manner, with the following exception: in the first stage of the sleeve travel, when the base 2 is against the injection site The sleeve trigger 12 is moved relative to the base 2 in the proximal direction P to remove the gap 33 between the distal end face 12.10 of the sleeve trigger 12 and the internal trigger button 13. As in the embodiment of Figures 1 to 15, this movement unlocks the stop mechanism 18 and the trigger button 13. In the second stage of the sleeve travel, when the user continues to press the sleeve trigger 12, thereby further advancing it in the proximal direction P, the distal end face 12.10 strikes the internal trigger button 13, thereby pressing it down to the first set The ring 20 is released from the base 2 and the control spring force is coupled to the carrier 7. The carrier 7 is advanced until the inner trigger button 13 stops on the other rib in the outer casing 12 and the plunger release mechanism 27 is released (note that the peg 14 is shorter in this embodiment).

From a user perspective, the stop mechanism 18 is configured to provide a resistance when the user reaches the second stage of travel of the sleeve. Internally, this is no different from the embodiment of Figures 1 to 15.

The needle extension is triggered by the user fully propelling the sleeve trigger 12 during the second phase of sleeve travel, whereby the internal trigger button 13 is fully depressed and the stop mechanism is overcome in the embodiment of Figures 1-15.

When the button is pressed, the control spring 19 takes over and fully advances the carrier 7 to extend the needle. In the third state shown in FIG. 15C, the internal trigger button 13 reaches the bottom of an inner fifth rib 12.11 of the sleeve trigger 12. And the internal trigger button 13 is switched back to lock to the sleeve trigger 12.

The embodiment of Figures 26A and 26B can also combine the additional features shown in Figures 16 through 25.

Figure 27 is a longitudinal cross-sectional view of the distal end of the autoinjector with an alternate feedback release mechanism 31 prior to triggering in a first position. A plunger actuated on a syringe or stopper (not shown) is retained within a syringe carrier 7. A trigger button 13 is provided on the distal end of the syringe carrier 7. A drive spring 8 is disposed in the carrier member 7 and is distally grounded in the carrier member 7 and abuts against a thrust surface 11 on the plunger 9. A distal plunger sleeve 17 is attached to the thrust surface 11 at a distal position and is disposed inside the drive spring 8. A feedback member 28 includes an elongated portion 28.1 disposed in the distal plunger sleeve 17 and a whole seated in the first position The distal tip 28.4 in the centered carrier 7 and thus cannot be seen or felt by the user.

A feedback spring 29 is configured to bias the feedback member 28 in a distal direction D relative to the plunger 9 by a proximal abutment against the thrust surface 11 and distally abutting the feedback member 28.

Both the drive spring 8 and the feedback spring 29 are pre-stressed. The plunger 9 is coupled to the carrier 7 by a plunger release mechanism (not shown). As in one of the above embodiments, a plunger release mechanism can be provided.

The distal plunger sleeve 17 includes two resilient ramp latches 17.1 that hold the feedback member 28 by engaging one of the ramps 28.5 of the feedback member 28. The latches 17.1 are externally supported by the thickened wall portion 7.23 of a carrier member 7 in such a manner as to prevent them from being deflected outwardly by the bevels under the force from the feedback spring 29. Therefore, the feedback member 28 cannot be released in this configuration.

Figure 28 is a longitudinal cross-sectional view of the distal end of the autoinjector 1 having the alternative feedback release mechanism 31 of Figure 27 after release in a second position.

The plunger 9 has been released by the plunger release mechanism and is thus moved in the proximal direction P to remove the stopper. During the proximal movement of the plunger 9, the ramp latch 17.1 on the distal plunger sleeve 17 has left the thickened wall portion 7.23 and enters a widened portion, and under the force from the feedback spring 29, they are moved by the bevel External deflection. The feedback member is driven by the feedback spring 29 through the distal end of the carrier 7 to advance in the distal direction D, whereby when the feedback member 28 reaches the second position, the distal tip 28.4 is ultimately passed through a hole 13.7 of the trigger button 13 The distal end of the trigger button 13 protrudes. The distal tip 28.4 is thus visible to the user. If the user still keeps the thumb pressed against the trigger button 13, they can also feel the distal end slightly 28.4 with their thumb. The slanted surface 28.5 from the internal collision trigger button 13 can produce an audible feedback and a tactile impact.

The distal plunger sleeve 17 can have one or more resilient ramp latches 17.1. At least one resilient ramp latch 17.1 can likewise be directly coupled to the thrust face 11 on the plunger 9, such that the distal plunger sleeve 17 is not required.

The trigger button 13 can be coupled to the carrier 7 or a housing (not shown) that surrounds the carrier 7. The trigger button 13 does not necessarily have to remain in the same longitudinal position of the carrier 7. Instead, at the end of the medicament, the trigger button 13 can still be located at the end of the housing (not shown) and the carrier 7 with all its internal components has been advanced into the housing. To this end, the feedback spring 29 and the feedback member 28 must be designed to be strong and long enough to ensure the end of the medicament The feedback member 28 still reaches the trigger button 13 such that the distal tip 28.4 can protrude from the trigger button 13.

The feedback member 28 can be designed to be released at the end of the plunger 9 and the stopper reaching their medicament position, preferably immediately before this condition.

The feedback member 28 according to Figures 27 and 28 can be combined with the embodiment shown in Figures 1 to 26, wherein the individual trigger button 13 or the pleated sleeve trigger 12 should be provided with a hole 13.7 and the feedback member 28 should have a distance Bit tip 28.4. The release of the feedback member 28 can be achieved by one of the feedback release mechanism 31 of Figures 27 and 28 or the feedback release member illustrated in other embodiments.

The feedback release member 31 according to Figures 27 and 28 can be equally applied to other forms of autoinjectors. For example, the syringe carrier 7 can be used as part of the outer casing or outer casing rather than being disposed within an additional outer casing. Likewise, the aperture 13.7 can be provided in a portion of the housing or pleated sleeve trigger instead of the trigger button 13.

The distal tip 28.4 can be a different color than the trigger button 13, for example, red, to improve the visual indication so that the user perceives that the end of the medicament has arrived and the device has been used.

It goes without saying that in all of the bevel joints between the two members described above, there may be only one bevel on one or the other member or there may be a bevel on the two members without significantly affecting the bevel engagement.

The term "drug" or "agent" as used herein, means a pharmaceutical formulation containing at least one pharmaceutically active compound, wherein in one embodiment, the pharmaceutically active compound has a molecular weight of up to 1500 Da and/or a peptide or protein. , a polysaccharide, a vaccine, DNA, RNA, an antibody or fragment thereof, an enzyme, a hormone or an oligonucleotide, or a mixture of the above pharmaceutically active compounds.

In another embodiment, the pharmaceutically active compound is useful for treating and/or preventing diabetes or diabetic retinopathy, such as deep vein thrombosis or pulmonary embolism, acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer disease, Such as diabetic complications, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis, wherein in other embodiments the pharmaceutically active compound comprises at least one Diabetic peptides for the treatment and/or prevention of diabetes-related complications, such as diabetic retinopathy, wherein in other embodiments pharmaceutically active compounds, including at least one human insulin or human insulin analog or derivative, pancreatic hyperglycemia A peptide-like peptide (GLP-1) or an analogue or derivative thereof or an analog or derivative of exedin-3 or exedin-4 or exedin-3 or exedin-4.

Insulin analogues such as glycine (A21), arginine (B31), arginine (B32) human insulin, lysine (B3), glutamic acid (B29) human insulin, lysine (B28), Pro ( B29) human insulin, ASP (B28) human insulin, human insulin, wherein the proline at position B28 can be replaced by aspartic acid, lysine, leucine, valine, alanine and position B29 Lysine can be substituted by Pro; alanine (B26) human insulin; DES (B28-B30) human insulin; DES (B27) human insulin and Des (B30) human insulin.

Insulin derivatives are, 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-( Omega-carboxyheptadecanoyl) human insulin.

Exendin-4, for example, means Exendin-4 (1-39), a peptide in the order of H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln- 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.

The Exendin-4 derivative is, for example, selected from the compounds listed below: 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 Exendin-4 (1-39), des Pro36[Asp28]Exendin-4(1-39), des Pro36[IsoAsp28]Exendin-4(1-39),des Pro36[Met(O)14,Asp28] Exendin-4 (1-39), des Pro36[Met(O)14, IsoAsp28]Exendin-4(1-39), des Pro36[Trp(O2)25, Asp28]Exendin-4(1-39), des Pro36[Trp(O2)25, IsoAsp28]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, IsoAsp28]Exendin-4(1-39); or des Pro36[Asp28]Exendin-4(1-39), des Pro36[IsoAsp28]Exendin-4(1-39),des Pro36 [Met(O)14, Asp28] Exendin-4 (1-39), des Pro36[Met(O)14, IsoAsp28]Exendin-4(1-39), des Pro36[Trp(O2)25, Asp28]Exendin -4(1-39), des Pro36[Trp(O2)25, IsoAsp28]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, IsoAsp28]Exendin-4(1-39), wherein the group-Lys6-NH2 can be bound to the C-terminus of the Exendin-4 derivative; or a Exendin-4 derivative in the order: des Pro36 Exendin-4(1-39)-Lys6-NH2(AVE0010), H-(Lys)6-des Pro36[Asp28]Exendin-4(1-39)-Lys6 -NH2, des Asp28 Pro36, Pro37, Pro38Exendin-4(1-39)-NH2, H-(Lys)6-des Pro36, Pro38[Asp 28]Exendin-4(1-39)-NH2,H-Asn-(Glu)5des 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,H-des Asp28 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)-(Lys)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-desPro36, 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 of any of the above-exemplified Exendin-4 derivatives Or solvate.

Hormonal hormones such as pituitary or hypothalamic hormones or regulatory active peptides and their antagonists are listed in Rote Liste, 2008 edition, Chapter 50, such as Gonadotropine (follicle stimulating hormone, Lutropin, Choriongonadotropin, Menotropin), Somatropine (growth hormone) ), desmopressin, terlipressin, gonarlin, triptorelin, leuprolide, buserelin, Naparelin, goserelin.

The polysaccharide is, for example, a glucosaminoglycane, hyaluronic acid, heparin, low molecular weight heparin or ultra low molecular weight heparin or a derivative or sulfate thereof, for example, a polysulfate form of the above polysaccharide and/or a pharmaceutically acceptable salt thereof and a poly The form of sulfuric acid. An example is a polysulfate low molecular weight heparin enoxaparin sodium which is a pharmaceutically acceptable salt.

Antibodies are globular plasma proteins (~150 kDa), also known as immunoglobulins that share a basic structure. Because they have additional amino acid residues in the sugar chain, they are glycoproteins. The basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only one Ig unit), and the secreted antibody may also be a dimer having two Ig units, such as a dimer having IgA, 4 Ig units of tetramers, like teleost fish IgM, or pentamerics of five Ig units, such as mammalian IgM.

The Ig monomer is a "Y" shaped molecule comprising: four polypeptide chains; two identical heavy chains and two identical light chains to which a disulfide bond is attached between cysteine residues. Each heavy chain is about 440 amino acids in length; each light chain is about 220 amino acids in length. Each of the heavy and light chains contains an intrachain disulfide bond to stabilize its folding. Each chain is called an Ig domain The composition of the domain. These domains contain about 70-110 amino acids and are classified into different classes (eg, variable or V, and constant or C) depending on their size and function. They have a unique immunoglobulin fold in which two beta sheets produce a "sandwich" shape that is held together by the interaction between retained cysteine and other charged amino acids.

There are five types of mammalian immunoglobulin heavy chains, represented by α, δ, ε, γ, and μ. The types of heavy chains that are present define the type of antibody; these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively.

Different sizes and different heavy chains of the composition, alpha and gamma contain about 450 amino acids and δ about 500 amino acids, while μ and ε have about 550 amino acids. Each heavy chain has two regions, the constant region (C _H) and a variable region (V _H). In one species, the constant regions are essentially identical across all antibodies of the same class, but are different in different classes of antibodies. The heavy chains γ, α and δ have a constant region composed of three immunoglobulin domains in tandem, and a hinge region for increased flexibility, the heavy chain μ and ε have a constant region composed of four immunoglobulin regions. The variable regions of the heavy chain are different in antibodies produced by different B cells, but all antibodies produced by a single B cell or B cell clone are identical. The variable region of each heavy chain is about 110 amino acids long and consists of a single immunoglobulin region.

In mammals, there are two types of immunoglobulin light chains, λ and κ. A light chain has two consecutive domains: a constant region (CL) and a variable region (VL). A light chain is approximately 211 to 217 amino acids in length. Each antibody contains two light chains that are always identical, and only one type of light chain, kappa or lambda, is presented to each antibody in a mammal.

Although the general structure of all antibodies is very similar, the unique properties of a given antibody are determined by the variable (V) region, as described above. More specifically, the variable loops, three on the light chain (VL) and three on the heavy chain (VH), are responsible for binding to the antigen, ie, responsible for its antigen specificity. These loops are referred to as complementarity determining regions (CDRs). Since the CDRs from both the VH and VL regions contribute to the antigen binding site, it is a combination of heavy and light chains, rather than being used alone, which determines the ultimate antigen specificity.

"Antibody fragment" comprises at least one antigen-binding fragment as defined above and which substantially exhibits the same function and specificity as the intact antibody from which the fragment is derived Sex. The immunoglobulin prototype was cleaved into three fragments by limited protease hydrolysis of papain. Two identical amino terminal fragments, each containing one intact L chain and about half of the H chain, antigen binding fragment (Fab). The third fragment, a similar size, but containing half of the carboxy terminus of the two heavy chains with their disulfide linkages between the chains, is a crystallizable fragment (Fc). FC contains carbohydrates, complement binding, and FcR receptor binding sites. Limited pepsin digestion yields a single F(ab')2 fragment containing both the Fab sheet and the hinge region, and the hinge region includes a disulfide bond between the H-H. F(ab')2 is the divalent of antigen binding. The disulfide bond of F(ab')2 can be cleaved to obtain Fab'. Furthermore, the variable regions of the heavy and light chains can be fused together to form single stranded variable fragments (scFv).

Pharmaceutically acceptable salts are, for example, acid addition salts and base salts. The acid addition salt is, for example, hydrochloric acid or a hydrobromide salt. The basic salt is a salt such as a salt having a cation selected from a base or an alkali, such as Na+, or ķ+, or an internal Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), in which the other R1 to R4 means: hydrogen, an optionally substituted C3 5233-alkyl group, a selectively substituted C2-5233-alkenyl group, an optionally substituted C6-C10 aryl group or an optionally substituted C6- group. C10-heterocyclic group. A further example of a pharmaceutically acceptable salt is in "Remington Pharmaceutical Sciences" 17. Version. Alfonso. Jinnaro (editor), Mark Publishing Company, Easton, Pennsylvania, USA, 1985 Encyclopedia of Chinese Medicine Technology.

Pharmaceutically acceptable solvates are, for example, hydrates.

7‧‧‧Ship

7.4‧‧‧Load stop device

12‧‧‧ Shell

12.1‧‧‧First outer casing stop

13‧‧‧ trigger button

13.1‧‧‧ 近梁

13.2‧‧‧ outward first slope

13.3‧‧‧Inward second bevel

D‧‧‧ far end, far direction

I‧‧‧Inward direction

O‧‧‧ outward direction

P‧‧‧ proximal and proximal directions

Claims (9)

An injection device for supplying a dose of a medicament (M) comprising: a casing (12) having a proximal end and a distal end; a carrier (7) for accommodating a syringe (3); a trigger button (13), wherein in a first state, the trigger button (13) is coupled to the outer casing (12) and/or the carrier (7) and abuts the distal end of the outer casing (12) , wherein, in an intermediate state, the outer casing (12) moves proximally relative to the carrier (7) and the trigger button (13), and the trigger button (13) engages the carrier (7), and wherein In a second state, the trigger button (13) and the carrier (7) move proximally relative to the housing (12) and the trigger button (13) disengages from the carrier (7) and engages the housing (12) . The injection device of claim 1, wherein the trigger button (13) comprises a deflecting beam (13.1) for engaging the outer casing (12) and the carrier (7). The injection device of claim 2, wherein the outer casing (12) comprises a casing stop (12.1) for engaging the beam (13.1). The injection device of claim 3, wherein the beam (13.1) comprises a first bevel (13.2) for engaging the outer casing stop (12.1). The injection device of claim 2, wherein the carrier (7) comprises a carrier stop (7.4) for engaging the beam (13.1). The injection device of claim 5, wherein the beam (13.1) comprises a second bevel (13.3) for engaging the carrier stop (7.4). An injection device according to claim 2, wherein in the first state, The beam (13.1) engages the outer casing stop (12.1) and/or the carrier stop (7.4). The injection device of claim 3, wherein in the second state, the beam (13.1) engages the outer casing stop (12.1) and the beam (13.1) abuts the carrier (7) . The injection device of claim 5, wherein in the intermediate state, the beam (13.1) engages the carrier stop (7.4) and the beam (13.1) abuts the outer casing (12).