SI9012289A - Injection device for self-administering purpose - Google Patents

Abstract

The application describes the input device, especially the self-injection device a device comprising a body for holding the container (16) ready-to-use medicinal substance, triggering the mechanism (47) and the means (46) for issuing said a medicinal substance regulated by a triggering mechanism. The body is made up of two parts (40.41), of which it is one moveable relative to the other, with has one (40) trigger (66) ("cock") and mentioned the actuation mechanism (47) is partially actuated by displacement triggered (66) said first part and partly s by moving the second part (41) relative to said first part (40), in that the actuation is complete only in the case of simultaneous actuation of the trigger and shift part two. After all this, the emptying agent does not can trigger an accident.

Description

GLAXO GROUP LIMITED London, United Kingdom

Input device

The present invention relates to an introductory device for administering a predetermined dose of a pharmaceutical substance, in particular to an apparatus for self-injection thereof.

Self-administered devices for administering pharmaceutical compounds are known, especially for the needs of diabetics for injection of insulin. It is noted that the charging of such known devices is complicated, the use of them is inconvenient and noisy and that the devices require very accurate handling. However, as diabetics need injections on a well-prescribed basis, they learn how to use the device at a rhythm and get used to it.

For one such known device, a pre-filled conventional syringe (injection) is inserted into the cylindrical intake chamber and the spring piston is pulled and locked after reaching the extracted position. When injecting insulin, the device is placed on the skin, the spring is released at the push of a button, and the syringe is pushed into the skin, after which this piston squeezes the hollow syringe plunger to inject the insulin. After use, the syringe is discarded and a new syringe is inserted, which needs further injection.

Apparatuses such as those described above are presented, for example, in EP 0338806 (Owen Mumford Ltd.), WO 88/08725 (Haselmeier), DE 39 60 926 (Dietronic) and DD 262585 (Tech Hoch, Merseburg).

For the second version of the self-propelled device, a product of Owen Mumford Ltd (as far as the applicant is aware, the device in question is not described in any patent file), the actuator button is located on the side of the device and is locked in position by a stop to prevent accidental triggering. The pin can be separated from the button by sliding along the length of the device.

Patents US 4329988, 4226235,3882863 and 3712301 (all in the name of Survival Technology Inc.) concern antidote entry devices for military personnel in the event of chemical warfare. These automatic injectors are triggered when pressed against the thigh. Early release is prevented by a safety cover that has a center pin that prevents the piston from loosening.

In the prior art there remains a need for an improved self-initiating device, the use of which is easy for you and easy to see. The device is intended to be usable by a single user even if it is completely inexperienced and should allow a small, accurate dose to be administered either subcutaneously (subcutaneously) or into a muscle (intramuscular). The aim of the present invention is therefore to create a device for the convenience of simple users, the unmanageable use of self-injection techniques, of course, the device will of course also come in handy for regular customers.

The aforementioned need arises because pharmaceutical compounds exist, such as sumatriptan, which is useful in the treatment of migraine and related problems, such as. migraine neuralgia (cluster headache), given only in small doses and relatively infrequently so that the user does not gain experience using the injection device. Furthermore, since migraine attacks can occur suddenly, there is a need for a compact and portable device that can be used quickly and discreetly.

According to the present invention, an intake device is provided comprising the body for receiving the container with the substance to be introduced, the actuating mechanism and the means controlled by the actuating mechanism for draining said substance, in which (namely, the device) the body is assembled of two parts, one of which is relative to the other movable, in that one part has a trigger (cock) and said actuator is partially actuated by the actuation of said one of the parts and partially actuated by the motion of the other part against said one of the parts, but fully activated only on the basis of both, both the actuation of the actuator and the movement of the other part, so that the emptying agent cannot be accidentally activated.

Preferably, one part of the body is slidably mounted within the other and extends out of the latter. In a preferred embodiment, the actuator is mounted on one end of one of the two parts - one that is mounted on the other, the actuator of the other part being a push button against which the actuator moves as one part moves inside the other.

Preferably, the syringe container is held in one of the aforementioned parts. By activating the emptying agent, the syringe is first moved forward within this one of the portions to display a needle, i.e. for the needle to penetrate the skin, and secondly the hollow plunger of the syringe is pushed down to allow the substance to pass into the wearer. The syringe can be held against the force of a spring inside this one part.

In a preferred embodiment, the intake device is elongated, slender and generally cylindrical and therefore similar to a fountain pen. The emptying agent inside the device may be an elongated push rod, which is suppressed by an elastic force.

The actuating mechanism may comprise two arms over which the end of the thrust rod is held, the rod being released on the basis of the relative movement of the arm separation button.

The part of the device moving in the second is preferably again composed of two parts: the first extending out of the device and designed as a sleeve for holding the syringe, and the second inside the device surrounding the pusher rod, the first and second parts the part of the device in question is mutually compatible.

The syringe sleeve as such can be made of two parts - an inner sleeve and an outer sleeve, which are relatively mutually moving against the force of the spring.

In all embodiments of the invention, we are faced with the great advantage that the inlet device cannot be accidentally triggered. The actuator can only be actuated by two completely different movements - actuating the actuator and moving one part of the device relative to the other. The actuator is in preferred embodiments at the far end of the device so that the said operations cannot occur together, except in a very deliberate action.

According to one aspect of the invention, the intake device is designed together with a housing for at least one container with the substance to be discharged, the housing comprising a removable container sleeve, a means for holding the sleeve in the housing and the container in the sleeve, wherein said sleeve has a means of releasably connecting itself to the inlet device, so that the sleeve and container can be removed from the housing based on cooperation with the inlet device and returned to the housing after use.

The housing preferably has a lid that is closed when the used container is returned to it. The container is preferably a syringe, and the syringe may have a rubber cap that protects the needle, leaving that cap in the housing when the intake device removes the sleeve.

The syringe is preferably held against the force of the spring in the sleeve. In one embodiment, the releasable sleeve connection may be a screw connection, alternatively it may be a bayonet groove and tongue or snap connection.

In a preferred embodiment, the housing and intake device are arranged within a single enclosure. The housing may have a recess for the intake device, the recess containing the actuating means of the actuating mechanism when the device is inserted into the recess.

The advantage of this arrangement is that individual containers of the substance ready for administration can be safely stored before use without any risk of injury to the user with the exposed needle. In the first case, each syringe is packed in a sleeve, and in the second case, the needle of each syringe is covered with a rubber cap. Syringes are easily loaded into the intake device without the user touching the syringe directly, and the used syringes are returned to the housing and retained therein without the user touching the syringe directly.

The housing is preferably designed as a disposable unit which is safely discarded after use of the syringe or the respective syringe.

In another embodiment of the invention, the container is movable within the body toward the emptying agent, and the device further comprises means for preventing emptying of the substance until the emptying agent is activated by the actuating mechanism, so that loading of the container into the body can simultaneously activate the emptying agent by the actuating mechanism.

Which syringe container can be provided with a rubber cap over the syringe needle so that the syringe is secured, so the syringe as such can be used to move the emptying agent, usually against the force of a spring.

In all embodiments, the syringe may advantageously contain a pharmaceutical substance, such as sumatriptan, for use in the treatment of migraine and related problems such as migraine neuralgia.

Preferred embodiments of the invention are described below in detail only by way of example, with reference to the accompanying drawings in which Figs. 1 is a housing that holds an inlet device and a housing according to one aspect of the invention, in a spatial representation, FIG. 2, an inlet device and a housing of FIG. 1 in a disassembled state, FIG. 3 illustrates a sketch housing of FIG. 1 and 2 in a state-of-art disassembled state in FIG. 4 is a cross-sectional view of the housing of FIG. 3, FIG. 5 is an introductory device of FIG. Fig. 3 is an exploded state in a spatial representation, without a sleeve, which is still in the drawings in the housing, FIG. 6 is a cross-sectional view showing the connection of the intake device inside the housing for the connection of the sleeve and the intake device; FIG. 7 to 10, the entire intake device, including the sleeve, in cross section, showing the operation of the syringe intake device, with cross sections in a plane perpendicular to the cross section of FIG. 6, FIG. 11 is a complete intake device according to the second embodiment of the invention, in a spatial projection, FIG. 12 is a planar spaced spatial representation of the apparatus of FIG. 11, FIG. 13 is a space-spaced drawing of a portion of the apparatus of FIGS. 11 and 12; 14 to 16 are sections of the apparatus of FIGS. 11 and 12, FIG. 17 is a spatial representation of a syringe cartridge for use in the third aspect of the invention; 18 is a cartridge of FIG. 17 in a disassembled state, FIG. 19 to 21, an intake device according to a third aspect of the invention, in cross-sections, showing syringe stuffing, and FIG. 22 to 24 cross sections similar to FIGS. 19 to 21, which outlines the steps for preparing a device for use.

Sketch of FIG. 1 shows in a spatial representation of the housing 1 of the syringe, which consists of the base part 2 and the cover 3, which is hinged to the base part 2. When the cover 3 is closed, the box 1 is pleasing to the eye and fits neatly into the user's pocket or purse. As can be seen more clearly from the drawing-disassembled state of FIG. 2, the base part 2 of the housing comprises a molded part 4 into which the latch 5 is fitted by means of a snap-lock, which has an integral shimmer 6, which contains two snap-adjusting tongues 7 for insertion into the corresponding hole 7a in the lid. The sleeve insert 5 comprises a cylindrical recess 8 and generally an elongated recess 9 adjacent to the cylindrical recess.

The recess 8 is for the syringe intake device 10 and the elongate recess 9 is for the syringe housing 11. In this drawing embodiment, the housing of the syringe cartridge 11 comprises two disposable syringe cartridges, and in other embodiments it may have only one syringe cartridge or more than two cartridges.

The insert 5 of the housing is locked to the molded part 4, and the housing 11 for the cartridge is snapped to the insert 5 of the housing and the molded part 4, so that the repeatably lockable covers 12 are just above. Each of the two flexible arms 13 on the housing 11 of the cartridge has a circular pad 14 at its end, with this pad fitting to an adapted circular hole 14a, one on each side of the molded portion

4. During use, press the pad 14 to remove the housing 11 when replacement is required.

The housing 11 for the syringe cartridge is presented in more detail in FIG. 3. In this drawing, only one cartridge 15 of the syringe is shown in the disassembled state. The housing 11 has a base member latch that snaps into place with the housing having a flexible arm 13, discussed above.

Each syringe 16 housed in a twin housing 11 for the syringe cartridge is pre-filled with a predetermined amount of drug and comprises a glass arrow 17 containing the drug and sealed with a rubber stopper 18. The needle 19 of the syringe (not shown in this drawing) is protected by a rubber cap 20. The arrow has a flange 21 and a cap 22. The syringe is arranged inside the sleeve assembly 23, which consists of an inner sleeve 24 and an outer sleeve 25, and a light spring 26 between them. The fit of the syringe will be described in more detail later. Push the sleeve assembly 23 into the housing 11 of the syringe cartridge by pushing as described later.

As can also be seen from FIG. 4, the inner sleeve 24 fits inside the upper section 27 of the outer sleeve 25 of the syringe, this fitting being possible on the basis of the slots 28 in the inner sleeve 24 of the syringe, allowing the sides of the sleeve to be displaced inwardly. The slots 28 match the longitudinal ribs 29 on the inside of the outer sleeve 25. This match prevents the rotation of the inner sleeve 24 relative to the outer sleeve 25. The ribs 29 also restrict the movement of the inner sleeve 24 to the outer sleeve 25, i.e. when the ribs 29 are at the end of the slots 28, no further movement is possible. When the inner sleeve 24 is housed in the outer sleeve 25, the outer projections 30 on the inner sleeve are located below the inner annular sill 31 at the top of the outer sleeve 25. Thus, the inner sleeve cannot move out of the outer sleeve. The movement of the inner sleeve 24 into the outer sleeve 25 is counteracted by the force of the light spring 26 located between the upper flange 32 of the inner sleeve and the upper end 33 of the outer sleeve 25.

The outer sleeve 25 of the syringe comprises between the two ends an annular groove 34 and, at its upper end, a threaded thread 35 for connection with the adapted threaded portion of the syringe actuator. This link will be described later.

The sequence in which the components described above are assembled is as follows. The spring 26 can be positioned around the inner sleeve 24 of the syringe. Insert the inner syringe 24 into the outer syringe 25. The hub assembly is then inserted into the cartridge housing 11 for the syringe to place the bead 34 below the annular ridge 36 on the inside of the cartridge housing. Subsequently, a syringe 16 is inserted into the sleeve assembly so that the flange 21 at the upper end of the syringe sleeve hits the end of the inner sleeve 24.

Sketch of FIG. 4 shows a sleeve assembly inserted into the housing 11 for cartridges and one of the syringes 16 inserted into a housing assembly 23. In this position, the lower end of the outer sleeve 25 is surrounded by a hollow cylindrical projection 37 at the base 38 of the housing. This protrusion is more clearly visible in the recess on the right side of the cartridge housing 11. On the inside of the upper edge of the cylindrical projection 37 there is a ring tooth 39. When the syringe 16 is pushed into the sleeve assembly in the housing 11, the gum 22 of the rubber cap 20 comes under this tooth 39.

Sketch of FIG. 5 shows a syringe-triggering device 10 in the spaced state. The actuator 10 comprises an outer housing 40 and an inner stem 41 that slides inwardly over the outer housing 40. The slots 42 on the inner stem 41 slide over longitudinal inner ribs 43 (not visible) of the outer housing 40 and prevent rotation of the inner stem 41 relative to the housing 40. The lower part of the inner stem 41 has a larger diameter and a step 44 is formed between this wider portion and the rest of the stem.

The inner stem 41 includes a hollow piston assembly 45 comprising a thrust rod 46 and a retaining end nozzle 47 which are pushed apart by a spring 48. At the top of the thrust rod is a head 50 which is separated from the thrust rod rest by a thin neck section 51. the head 50 snaps beyond the top of the two arms 52 of the retaining front attachment 47.

Also, the retaining end nozzle 47 comprises a main, hollow body shaped section 55 and a thin cylindrical projection 56 extending out of the body section 55 and for insertion into the end of the inner stem 41. The inner step 57 (see FIG. 6) between the body part 55 and a thin section 56 forms a bearing for the spring 48. The bearing for the other end of the spring 48 determines the annular ring 58 on the thrust rod 46. There is a step 59 between the arms 52 and the body 55.

The latch 60 at the upper end of the inner stem 41 engages in a circumferential slot 61 in the body section 55 of the retaining front attachment 47.

The actuating device also comprises a flexible actuator assembly 64 comprising a cap 65 which defines the actuator button 66 seat, together with a button spring 67. The trigger button 66 comprises a pair of arms 68, the position of which is in the slots 69 between the arms 52 of the retaining front attachment 47. The spring 67 is held between the annular edge 70 of the trigger button 66 and the step 59 of the main body of the retaining front attachment. An inclined section 71 is located at the end of the two arms 68 closest to the annular edge 70 of the actuator knob; in other words, each arm 68 expands in a frantic way as the button section approaches.

This fluffy extending portion of each arm, when pushed into the slot 69, tends to separate the arms 52 of the retaining front attachment 47.

The cap 65 for the button 66 closes in the housing 40, with the annular projection 73 on the outside of the cap 65 projecting into the annular groove 74 on the inside of the outer housing 40. The cap 65 also has two flexible arms 75 which form the projection 73 and which are when the cap is inserted into the outer housing 40, forced in there to limit the travel of the button 66. It should also be noted that there is a screw thread 76 (see Fig. 6) on the inner surface of the button of the inner stem 41 for connection with the screw thread 35 of the outer sleeve 25 for the cartridge. The coupling of the actuator components will be described in further detail with the help of the sketch of FIG. 6.

The assembled actuation device 10 can be seen, specifically in cross section, in FIG. 6, which also shows the actuator 10 arranged in the housing 11 for the cartridges. Of course, while using the cartridge housing in the housing 1 of the drawings of FIG. 1 and 2.

As we can see in this sketch, the inner stem 41 is inserted into the outer stem 40 from below, the thrust rod 46 and the spring 48 are inserted into the inner stem from above, the retaining end nozzle 47 is inserted into the end of the inner stem 41, and the cap 65 snaps into the end outer housing 40.

It should be mentioned that the inner step 77, which is hit by the main body 55 of the retaining face 47, prevents the inner casing 41 from exiting the outer casing 40, and that the inner step 78 prevents the thrust rod 46 from coming out of the inner stem. 41.

To push the push rod 46 in place so that its head 50 is above the arms 52 of the retaining front attachment 47, it must be calculated that the push rod 46 moves towards the action of the spring 48. This can be done either by using a suitable push rod device 46 into the outer casing 40, but preference is given to inserting the actuator 10 into the cylindrical recess 8 of the main casing 1. The main casing 1 has an elongated protrusion 79 at its bottom (see FIG. 2) which is aligned with the cavity 8, which when actuated the device 10 is pushed into the recess, pushes the push rod 46 up to allow the push rod head to come over the arms 52 of the retaining front attachment 47. In fact, the housing 1 cannot be closed if the push rod is not clamped in this manner. It follows that the spring 48 of the actuator 10 can be tensioned in a simple and unobtrusive manner and the device is always ready for use.

The actuator 10 is inserted into the cartridge housing 11 simply by inserting it so that the inner stem 41 encloses the inner cartridge sleeve 24. When the actuator is fully inserted, rotate it so that the screw thread 76 of the inner stem 41 is gripped by the screw thread 35 of the outer sleeve 25 for the cartridge.

To remove the syringe cartridge from the housing 11 for the cartridge, the actuator 10 is simply pulled out of the housing. The initial actuation of the actuator releases the sleeve assembly 23 from the housing

11, separating ridge 36 and bead 34 from one another. After this displacement, the syringe 16 remains in the same position relative to the housing 11, since the force required to remove the rubber cap 20 from the syringe 16 is greater than the force of the syringe spring 26.

Further upward movement of the actuation device 10 compresses the syringe spring 26 so that the ribs 29 of the outer sleeve 25 reach the end of the slots 28 of the inner sleeve 24. Therefore, further upward movement releases the syringe 16 from the cartridge housing 11, although the rubber cap 20 remains in the housing 11, holds the tooth 39 of the cylindrical projection 37 at the bottom of the housing 11. The upward movement of the actuator 10 before the syringe is released shows the stroke X in FIG. 6. When all of the syringe actuator 10 is removed from the housing 11, the syringe spring 26 expands and moves the syringe up in the sleeve assembly 23 back to its original position.

The syringe self-injection device is then ready for the user to initiate. The activation steps are drawn in the drawings of FIG. 7 to 10. As shown in FIG. 7 and 8, the first step comprises the displacement of the inner stem 41 and the coil assembly 23 (which contains a syringe) in the outer casing 40. This displacement occurs when the user presses the device 10 toward the injection site. The description below will talk about the user's thigh, but this is only an example. The relative displacement is limited by the step 44 of the inner stem 41, to which the base of the outer housing 40 is hit. This displacement compresses the spring 67 of the knob and moves the retaining front nozzle 47 upward toward the actuating button 66. During movement, the arms 68 of the actuating button 66 move in the slots 69 of the restraint. 47. At the end of this movement, the fan parts 71 of the arms 68 of the buttons are located at the ends of the slots 69 of the retaining front.

Pressing the actuator button pushes the fan section 71 arms 68 of the button in the slot 69 of the retaining front attachment so that the arms 52 of the retaining front attachment are separated. It should be noted that pressing the button 66 without moving the inner stem 41 is not sufficient to move the fan parts 71 in the slot 69, the downward movement of the button 66 being limited by the arms 75 of the cap 65.

As FIG. 9, the separation of the arms 52 releases the head 50 of the thrust rod 46 and so the thrust rod moves forward with the force of the main spring 48. The thrust rod 46, which cooperates with the hollow piston 18 of the syringe 16, initially pushes the entire syringe 16 against the force of the syringe spring 26. This displacement of the needle 19 does not push the plunger 18 of the syringe 16, since the force required to eject the fluid from the syringe is greater than the force of the spring 26. Therefore, the displacement of the thrust rod 46 does not yet push the fluid out of the syringe. It should be noted that the downward movement of the syringe is 16, i.e. the depth of needle penetration determined by the slots 28 and ribs 29 of the sleeve assembly 23.

The last stage shown in FIG. 10, pushing down the hollow plunger 18 of the syringe with the pushing arm 46. Thus, when the needle 19 was opened and the needle penetrated the user's skin, the syringe 16 was emptied, i.e. the drug is transferred to the user.

It should be noted that the initial pressure of the device on the patient's thigh, thereby tying the first movement, tenses the skin, which means that when the needle pierces the skin, there is not much possibility of lateral movement of the needle relative to the skin and therefore the injection is relatively painless.

Furthermore, since, as noted above, neither the push of the button 66 nor the displacement of the inner stem 41 relative to the outer casing 40 alone can release the thrust rod 46, the device is internally safe and cannot be accidentally triggered.

It is advantageous to touch the device first with the thigh and then press the button, of course, the device strains if the button is pressed and held and then the device is pressed to the arm.

Once the drug has been injected, device 10 is removed from the thigh and the spent syringe cartridge is returned to the syringe housing 11 from which it came. The device 10 is then again pushed into the housing 11 so that the sleeve assembly 23 is locked therein. The actuator 10 is then rotated in the opposite direction to loosen the screw threads 35 and 76 and remove the device without the sleeve assembly 23 and syringe 16. The pushing of the syringe sleeve assembly in this way naturally moves the syringe 16 up the sleeve 21 and the needle is covered with a rubber sleeve. cap 20. Cover the housing 12 of the housing 11 to close the cartridge to airtight the spent syringe inside the housing. The spent cartridge cannot be accessed without the use of the actuator. The syringe used is therefore eliminated in a sophisticated and completely hygienic manner.

The actuator 10 can be repositioned in the cylindrical recess 8 for future use, and the enclosure 1 can be closed. Installing the actuator in the recess 8 moves the thrust arm 46 upwards and strains the main spring 48 for further use as described above.

Another embodiment of the invention is illustrated in FIGS. 11 to 16. The basic difference between the intake device shown in these drawings and the one described above concerns the fact that the device should be handed to the user in a state of immediate use. In other words, the user does not have to strain the trigger actuator itself or load the syringe assembly. In addition, the goal is to have the ready-to-use device in full disposable, so that when the drug substance is injected and the syringe is discharged, we get rid of the whole set of triggering device and the syringe cartridge. The user will have some complete input devices for future use.

This induction device, however, is very similar to the one described above and therefore, where applicable, the same reference numbers are used. In the present case, the syringe actuator 10 is substantially identical and comprises an outer casing 40 with an inner stem 41 movable therein. In the inner stem 41, the spring 48 is movable by a push rod 46, the head 50 of the thrust rod being held by the retaining front attachment 47. Further, the arrangement of the syringe 16 in the sleeve assembly 23 is the same as in the first embodiment except in connection with the actuator 10, as will be described later.

As in the first case, the intake device can only be triggered by pushing a button 66 while simultaneously moving the inner stem 41 and the outer housing 40. In other words, the operation of the syringe delivery device as described in the case of the first embodiment is the same in the present case. the present devices.

The complete intake device is presented in FIG. 11. In this sketch, we see the outer housing 40 and the detachable cover 101 together with the clamp 102, which fits into the periphery of the body of the intake device 10. As is clear from this sketch, the device is entirely - as in the first embodiment - similar in size and shape as a fountain pen, and the clip 102 allows the device to be carried in the user's pocket as if it were a fountain pen.

FIG. 12 shows the intake device in a ready-to-use state. In this presentation, the device is rotated so that the trigger button 66 is seen. The clip 102 is removed from the device, which is feasible on the basis of the flexible pin 103 of the clip. Removal of the clip 102 allows the inner stem 41 to move relative to the outer housing 40. Prior to removal of the clip 102, such movement is prevented.

This sketch also shows the removal of the detachable cover 101. The removal of this cover and the complete preparation of the device for use are described in detail later.

In FIG. 13 shows the syringe assembly 23 in the drawing state and the detachable cover 101. The syringe 16 of this device is the same as that of the first embodiment and contains a glass arrow 17 and a rubber cap 20. The syringe is arranged in the assembly i3 of two syringe sleeves - inner sleeve 24 and outer sleeve 25 as in the first case, with a weak spring 26 between them.

The difference between the sleeve assembly of FIG. 13 and the one of FIG. 3 is that the outer sleeve 25 has no threaded upper section provided. Instead, nozzles 117. are provided on the outside of the upper section of the outer sleeve 25. The corresponding nozzles 125 (Fig. 14) are provided on the inner side of the inner stem 41.

In FIG. 13, it can be seen that the detachable cover 101 includes a gripper section 118 for ease of use and an end cover 119 that is permanently inserted into the cover 101.

The interior of the detachable cover 101 can be seen from the cross sections in FIG. 14 to 16. Similar to the housing 11 of the cartridge in the first embodiment, the removable cover 101 comprises an inner hollow cylindrical projection 120 with a ring tooth 121 for retaining the cap 20. In fact, the adjustment of the thrust assembly to the cover 101 is the same as the adaptation of the thrust assembly to the housing of the cartridge in the first embodiment.

The sequence in which the components described above are assembled is as follows. The weak spring 26 is mounted over the inner sleeve 24 of the syringe. Insert the inner syringe 24 into the outer syringe 25. Then, a removable cover 101 is inserted on the outer sleeve 25 of the syringe so that the annular bead 34 jumps into the adapted annular recess 122 on the inside of the lid 101. The syringe 16 is then pushed into the assembly of the sleeve 16 to place the rubber cap 20 in the cylindrical projection 120 of the lid 101. The complete syringe, sleeve and lid assembly is then inserted into the actuator 10 to fit the nozzles 117 behind the adapted nozzles 125 on the inner surface of the inner stem 41; in this position, the rim section of the lid 101 is positioned opposite the leading edge of the inner stem 41.

As noted, the device is delivered to the user in a ready-to-use state. As noted in connection with FIG. 12, the first step in using the input device is to remove the clip 102. The next is to remove the cover 101. The removal of the cover is described in detail in the following. When pulling the travel cover X to the position of FIG. 15, the lid tends to pull the syringe 16 and thereby the inner sleeve 24 of the syringe. This is because the rubber cap 20 surrounding the syringe needle is at this stage held in the cylindrical protrusion 120 of the detachable cover 101. But which stroke X, as described above with respect to the first embodiment, the syringe 16 can no longer be move and only further pull on the lid 101 will allow the lid to be removed from the intake device, this drag also separating the rubber cap 20 from the syringe sleeve 17. The separation of the lid and the cap is shown in FIG. 16. Although on the basis of FIG. 15, it appears that when the rubber cap 20 is separated from the syringe sleeve 17 and the syringe needle 19 extends out of the syringe sleeve 107, the force of the spring 26 between the inner and outer sleeve 24, 25, pushes the syringe 16 back into the device. Thus, the needle 19 is still securely closed against the wearer.

Now that the syringe 16 has returned to its position as shown in FIG. 14, the intake device 10 is substantially in the same state as shown in FIG. 7. The operation of the intake device is as described with reference to FIGS. 7 to 10. Briefly, the user presses the device into the selected injection field so that the outer sleeve 25 and the inner stem 41 move inward relative to the outer housing 40. The trigger button 66 is then pressed. These two movements allow the pushing arm 46 to be released, which then moves the main spring 48 to move the syringe 16 forward and then press the hollow piston 18 to inject the pharmaceutical substance into the user.

Immediately after use, the detachable cover 101 can be pushed back to the device 10 by covering the exposed needle 19, and the assembly as a whole can then be safely disposed of.

A third embodiment illustrated in FIGS. 17 to 24, is similar to the first embodiment by moving the thrust arm 46 and tensioning the main spring 48 of the actuator and the full syringe assembly. The basic difference in this embodiment is that the filling of the syringe assembly is what moves the thrust rod 46 in the actuator and therefore the syringe is filled into the intake device and the main spring 48 is tensioned in one step. After filling the syringe 16 and the tension of the spring 48, the device is actuated essentially in the same manner as in the previous embodiments. In other words, the syringe 16 is released only as a result of the displacement of the inner stem 41 relative to the outer casing 40 and as a result of pressing the trigger button 66.

There are significant similarities between this embodiment and the first embodiment and therefore, wherever this occurs, the same reference numbers are used and the description is not repeated.

In this embodiment, the user is provided with a trigger device 10 and several syringes 16. The syringe assemblies are disposable and the trigger device is retained by the user for future use. The complete syringe cartridge 130 is illustrated in FIGS. 17 and 18. The cartridge comprises a first cover 131 and a second cover 132, both of which are mounted on the syringe assembly 23. A seal 134 is provided for records of tampering covering part of the first cover 131 and part of the sealing assembly 23, so that the user can be sure that the syringe 16 is intact and has never been touched before. The first cover 131 is removed when the syringe 16 is to be mounted on the actuating device 10. Whichever syringe 16 is installed, the second cover 132 becomes the main cover of the entire intake device, as in the second embodiment.

As shown in the drawing exhibited FIG. 18, the syringe cartridge comprises a syringe 16 containing a arrow 17 and a rubber cap 20, a weak spring 26, together with the syringe sleeves 24 and 25 of the first and second caps 131, 132, as previously described. The second cover 132 comprises an end cover 132a firmly integrated therein. The second cover 132 has an inner hollow cylindrical projection 137 having an outer screw thread 138, so that the second cover 132 can be screwed onto the outer sleeve 25 of the syringe, for which the outer sleeve has a corresponding thread on its inner surface. The cylindrical protrusion 137 is equivalent to protrusion 37 in the first embodiment and protrusion 120 in the second embodiment.

It is appreciated that, with the exception of the inner thread on the outer sleeve 25, the syringe assembly 23 is identical to the syringe assembly 23 of the first embodiment shown in FIG. 3.

With the second cover 132 screwed onto the outer sleeve 25, the syringe is inserted into the sleeve assembly as described above with respect to the previous embodiments.

It should be noted that when the syringe 16 is mounted in the sleeve assembly 23, the lower end of the syringe sleeve 17 rests on the flange of the cylindrical projection 137. The movement of the syringe sleeve 17 further into the sleeve assembly 23 is thereby prevented.

The syringe, sleeve and lid assembly is clearly visible from the bottom of FIG. 19. In this presentation, the first cover 131 has already been removed. As shown by the arrow, the syringe, sleeve and cover assembly are then pushed into the actuator 10, thereby loading the syringe 16 and simultaneously tensioning the main spring 48 of the actuator.

The syringe inner sleeve 24 slides in the inner stem 41 of the actuator 10. The thrust arm 46 enters the syringe sleeve 17 to the syringe rubber stopper 18. Further movement of the syringe and sleeve assembly into the actuator 10 pushes the pusher arm 46 upwards, as seen in FIG. 20. The syringe 16 is prevented from moving down because the lower end of the syringe sleeve 17 and the flange of the cylindrical projection 137 of the lid 132 are in contact. The stopper 18 cannot be moved down because the needle tip 19 of the syringe is hidden in the rubber cap 20 and therefore the contents of the syringe cannot be squeezed out.

In this way, the syringe and sleeve assembly is pushed into the actuation device 10 so that the head 50 of the pushing arm 46 is brought closer to the arms 52 of the retaining end nozzle 47. The syringe and sleeve assembly is then rotated so that the screw thread 35 of the outer sleeve 25 of the syringe is gripped by a modified screw thread 76 on the inner surface of the inner stem 41. Twisting the outer sleeve 25 into the inner stem 41 means pushing the head 50 of the thrust arm 46 over the arm 52 to tension the main spring 48.

The movement of the syringe and sleeve assembly into the actuator is shown in FIG. 20 and 21. As shown in FIG. 21, where the screw thread 35 of the syringe sleeve 25 and the inner thread 76 of the inner stem are joined, the thrust arm 46 is held in position when the head 50 is low for a small stroke Y above the arms 52 of the retaining front attachment 47. This stroke Y is provided to compensate for manufacturing variations in the various parts that make up the whole assembly. The existence of this additional stroke Y on the device does not impair its operation, as will be seen in the following description.

It should be noted that in this embodiment, there is no need for the clip 102 of the second embodiment, since the cap 132 screwed onto the syringe sleeve 25 prevents the pushing arm 46 from moving into the device and thereby moving the stopper 18 towards the pusher rod. 46.

In the palm of your hand, the existence of the cover 132 on the syringe sleeve 25 is essential for the displacement of the thrust arm 46 in the actuator 10 and thus for the tension of the main spring 48. If it had not been for when the sleeve assembly 23 had been pushed into the inner stem 41, syringe 16 and / or syringe stopper 18 easily moved down. The existence of the cover 132 also acts as an additional guarantee to the user that there is no danger of the needle peering through. This extra guarantee is extremely convenient as the user holds the syringe and sleeve assembly in the hand when straining the spring.

As noted above, the sketch of FIG. 21 shows an intake device 10 with a tensioned main spring 48. In order to use the device and release the syringe, the following steps are described, which are described with reference to the drawings of FIG. 22 to 24. These steps are similar to those described with reference to FIGS. 14 to 16 showing a second embodiment.

First, as shown by the circular arrow in FIG. 22, unscrew the lid 132. The initial movement down the stroke cover Y allows the syringe 16 to move within the syringe assembly 23 and the sleeves, thereby pushing the arms 46 forward to a position where the head 50 pushes the arms 46 to touch the retaining front attachment 47.

Further unwinding of cover 132 tends to pull the syringe 16 down into the syringe assembly 23 and the sleeves, since the rubber cap 20 is held in the tubular projection 137 of the cover. Thus, the syringe 16 tends to move downward for further stroke Z.

However, when cover 132 reaches the position shown in FIG. 23, the further movement of the syringe 16 is prevented by the cooperation of the ribs 29 and the slots 28, as previously described. In this position, the threads of the cover 132 and the syringe sleeve 25 are already apart and the cover 132 can be removed. By removing the cover 132, the rubber cap 20 and the syringe are also separated so that the needle 19 is then exposed.

When the lid is removed, the spring 26 of the syringe assembly 23 and the sleeves immediately moves the syringe back to the position shown in FIG. 22 so that the needle 19 is not exposed.

This position is presented in FIG. 24 and the intake device is now ready for use. The device is triggered as described in connection with the previous embodiments, so we do not describe it again here.

After use, the needle 19 is in the open state, but it can be safely protected by replacing the cover 132 on the syringe sleeve. The syringe and sleeve assembly 23, complete with the cover 132, can then be separated from the actuator 10 by separating the screw threads 35 and 76. The first cover 131 is then reattached to the syringe and sleeve assembly. This syringe, sleeve and cover assembly can therefore be discarded and the actuator is then ready to place a further syringe on it.

By authorization:

Patent Office Ljubljana, d.o.o. For her: Vinko Skubic, B.Sc. Patent Agent

Claims (17)

Patent claims An intake device comprising a body for holding a container with a drug substance ready for administration, a triggering mechanism and means controlled by a triggering mechanism for draining said substance, characterized in that the body consists of two parts, one being the part movable relative to the other; that one part has a trigger (cock) and that said actuating mechanism is partially actuated by actuating the actuator of said one part, and partially triggered by moving the other part towards said one part, while fully actuating it only if the actuator is actuated simultaneously and move the other part so that the emptying agent cannot be accidentally triggered. Injection device according to claim 1, characterized in that one part of the body is slidably mounted in the other and extends out of the other. Injection device according to claim 2, characterized in that the actuating mechanism is mounted on one end of one of the two parts, which is mounted in the other part, triggering the other part in the form of a push button against which the actuating mechanism moves, if the first part moves inside the second. Injection device according to claim 3, characterized in that the syringe container is held in said first part and that activating the emptying agent first moves the syringe towards that first part in order to open the needle, which means pushing it through skin, and secondly presses the hollow plunger of the syringe to allow the drug substance to flow into the wearer. 5. An intake device according to claim 3 or 4, characterized in that the emptying means is an elongated push rod, which is loaded with flexible force, and that the actuating mechanism comprises two arms over which the end of the thrust rod is held, releasing the rod by using the relative movement of the button to separate the arms. Injection device according to claim 5, characterized in that the first part of the device moving in the second is itself composed of two parts, the first part extending out of the device and in the form of a syringe receiving the syringe, the second part it accepts a thrust rod in the device, the first and second parts of this first part being interconnected with each other. Injection device according to claim 6, characterized in that said sleeve comprises an inner and an outer sleeve part, the sleeve parts being relatively movable against the force of the spring relative to each other. 8. An intake device according to any preceding claim, characterized in that the intake device is elongated and generally cylindrical and therefore similar in appearance to the flush. An intake device according to any preceding claim, characterized in that said drug substance is a pharmaceutical drug substance, as used in the treatment of migraine and associated problems such as migraine neuralgia (cluster headache). An injection device according to claim 9, characterized in that the pharmaceutical drug substance is sumatriptan. Combination of an introducing device according to claim 1 and a housing for at least one container of a ready-to-dispense drug substance, characterized in that the housing comprises a removable container sleeve and means for holding the sleeve in the housing freely, said sleeve having detachable means connecting itself to said second part of the intake device, so that if they co-operate with the intake device, the sleeve and container can be removed from the housing and returned to the housing after use. Combination according to claim 11, characterized in that the housing has a lid that is closed when the used container is returned to it. Combination according to claim 10 or 11, characterized in that it is a syringe container having a rubber cover that protects the needle, leaving that cover in the housing when the sleeve is removed with an intake device. Combination according to claim 13, characterized in that the syringe is held in a force bar of the spring. Combination according to claim 11 together with a combination housing, characterized in that the housing has a recess for the intake device, wherein the recess contains means for energizing the actuating mechanism when the device is inserted into the recess. 16. An intake device according to claim 1, characterized in that the container is movable in the body against the emptying agent and the device further comprises means for preventing the discharge of the drug substance until the actuator is coupled to the emptying agent by inserting the container into the body it can simultaneously combine the emptying agent with the actuator. Injection device according to claim 16, characterized in that the syringe container and the rubber cap are provided above the syringe needle to seal the syringe, so that the syringe alone can be used to move the emptying agent.