• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
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    • 专利摘要:
    device for an automatic injection of two doses of a drug. The present invention relates to an autoinjector of two doses of a drug in which the locking and release of the steering spring (27) of the autoinjector are controlled through stepped guide means (16, 24) with ramps for two successive slides along it the spring-operated slide means (28, 29) connected with the syringe (21) and relevant plunger (26). the guide means and the slide means are pivotable with respect to each other and the direction of slide, while the syringe can only slide axially, and the trigger control for each slide is obtained by pressing an axially slideable trigger (30) with respect to a stationary member (1), against the patient's skin to drive the slide means first on one ramp and then on the other ramp of the guide means. to allow or prevent sliding of the sliding means within the guide means an angularly movable cocking member (11) is provided formed with a guide rail (14) substantially equal to that of the stationary member on which the guide means is formed. after subsequent angular frame displacements of the movable member with respect to the stationary member the ramps and guide rail are radially aligned to allow the means to slide under spring action and thus delivering the first dose and then the second dose.
    公开号:BR112012022471B1
    申请号:R112012022471-9
    申请日:2011-03-09
    公开日:2021-06-29
    发明作者:Mark Jeffrey Edhouse；Patrick J. Ryan；Max William Middleton；Christopher Edward Butcher
    申请人:Menarini International Operations Luxembourg S.A.；
    IPC主号:
    专利说明:

    Description Field of Invention
    [0001] The present invention relates in general to devices for the injection of drugs and more precisely refers to a device for an automatic injection of drugs especially a drug for allergic emergencies, such as epinephrine or adrenaline, according to a sequence of time required. In particular, the present invention relates to a device for an automatic injection of two doses of a medicine in two successive times. Background of the Invention
    [0002] Many devices of the aforementioned type allowing a patient to self-administer one or more (usually two) doses of a drug are known. US 6 575 939 describes an autoinjector device comprising a syringe housed in a housing formed by an inner part and an outer part capable of sliding relative to one another. When pressing the end of the inner part (the exit end of the needle) against the patient's skin in the injection field, the outer part slides forward along the inner part, thus unlocking a push-button. Upon pressing the button, the syringe and relevant plunger are triggered to first push into the needle and then deliver the medication. Retraction of the needle into the sheath is achieved by stopping pressing the outer edge against the skin. Said autoinjector allows a single dose of medicine to be administered.
    [0003] An autoinjector device for automatically administering a single dose of a medicine is also known from US 4,031,893. The autoinjector is equipped with an unlocking device with a deformable member for the targeting device. The syringe plunger is axially connected to a rod comprising four flexible axial arms having a serrated end engaged with the edge of an opening formed in the cap disposed at the end of a syringe housing. Sliding the cap causes the ends of the arm to deform and its teeth to release from the edge of the opening. In this way the steering device is triggered. The autoinjector according to this document also comprises a safety device to prevent accidental deformation of the arm ends and triggering of the targeting device, consisting of an insertion device centrally extending from the cap and capable of being between the rod arms to prevent them from bending.
    [0004] EP700307 describes a two-dose autoinjector allowing the automatic delivery of a first dose of a drug and the manual administration of a second dose. The autoinjector device according to said patent provides for the use of a syringe slidably housed in a tubular housing in two parts that can be separated to allow the positioning of the syringe containing two doses of the medicine to be sent and its removal after the use. Sliding the syringe into the housing to penetrate the needle and inject the drug is operated by a movable actuator between an cocked position and an extended position. A releasable locking device is provided to limit the syringe plunger from sliding to an extent corresponding to the volume of the first dose. The syringe is mounted in the tubular housing in a movable mode to allow the locking device to be removed after the first dose is shipped and the plunger directing means to be cocked again if the second dose is to be automatically administered, or the syringe to be removed if the second dose has to be administered manually. Additionally the directing means is provided with a safety latch formed by a member engaging with a deformable pin of the directing means to keep it in a deformed condition, thereby preventing it from latching. An autoinjector of this type is commercially offered under the trademark Twinject® and allows the first dose to be administered automatically, but the second dose must be administered manually.
    [0005] The autoinjector according to EP651662 is designed to carry out a sequence of injections from a single syringe that is capable of performing a limited sliding movement in a tubular housing. The syringe has a plunger to send doses of a drug through a needle and spring-loaded means engages with a plunger rod and, once they are cocked, they retain the rod in a first position, while when they are triggered, cause the rod to move forward and this causes first syringe slide and needle projection and then a controlled slide of the plunger to deliver a dose of medication. Manual cocking means are provided and means for re-engaging the spring biasing means.
    [0006] The piston rod has a toothed profile in which a detent of the directing means engages and the syringe is housed in a bushing capable of moving in a limited manner in the tubular housing and provided with an additional detent that is also engaged with the toothed profile of the rod. When the device is armed by the manual arming means, not only the directing means but also the bush in which the syringe is disposed is moved towards the rear end of the tubular housing, the two detents engaging with the toothed profile of the rod. An axial groove connection between the bushing and the guide means allows additional sliding between the integral detent for the guide means and the toothed profile to an extent equal to the profile pitch. When the device is cocked, the directing means first causes the syringe bushing to slide to a front stop and then the rod starts to slide relative to the bushing holder to an extension corresponding to the profile pitch, with which the displacement one volume of medication is allowed along with its delivery through the needle.
    [0007] There is a strong need for an injector device for an automatic injection of a drug in two successive doses that is user friendly and is easier to manufacture compared to conventional devices. The aim of the present invention is therefore to meet said needs by providing a self-injecting drug device capable of allowing the patient to self-administer two successive doses of a drug as easily as possible, thus saving the patient from potentially performing operations dangerous, complex disassembly and reassembly. Summary of the present invention
    [0008] The basic idea of the present invention is to control the locking and release of the autoinjector steering spring by providing stepped guide means with ramps for two successive slides along them of slide means operated by the spring and connected with the syringe and relevant plunger. The guide means and the slide means are pivotable with respect to each other and the direction of slide, while the syringe can only slide axially, and the trigger control for each slide is obtained by pressing a trigger, axially slideable with respect to a stationary member, against the patient's skin to drive the slide means first on one ramp and then the other ramp of the guide means.
    [0009] To enable or disable the sliding of the sliding means within the guide means an angularly movable cocking member is provided formed with a guide rail substantially equal to that of the stationary member on which the guide means are formed. Thereafter, two subsequent angular frame displacements of the movable member relative to the stationary member the ramps and guide rail are radially aligned to allow the gliding means to slide under spring action and therefore to deliver the first dose and then the second dose.
    [00010] According to one aspect of the present invention, the injector device comprises a syringe assembly containing the drug to be delivered and arranged coaxially and slidably within an outer housing extending along a longitudinal axis and means for arming the device from a rest position to a first dose injection cocked position and a second dose injection cocked position, the device cocking means being disposed at one end of the outer housing. First elastic means which are in a compressed state when the device is in the rest position are provided between a syringe assembly and the device cocking means. Device directing means are further provided to control the sliding of a syringe assembly from the cocked position to inject the syringe needle into an injection field and send the first dose and, if necessary, send the second dose at a time. successive prefixed.
    [00011] A syringe assembly comprises sliding means engaged in stepped guide means inclined, but not incident, with respect to the direction of the longitudinal axis X and axially integral to the outer housing. The sliding means and the guide means are pivotable with respect to each other about the longitudinal axis and the directing means is axially slidable following separate and subsequent pressures against the injection field, thus causing a first relative displacement of the injection means. slide from the first armed dose injection position to a position of alignment of the guide means, whereby the slide means are free to travel therealong to a first stop position, and a second relative displacement of the means of sliding from the second armed dose injection position to a position of alignment of the guide means, whereby the sliding means are free to travel along it to a second stop position.
    [00012] In a preferred embodiment, the sliding means are axially and pivotally mounted to a syringe assembly, the guide means are rotationally integral with the outer housing and the stepped guide means comprise an inner housing in which a guide rail inclined with an intermediate region is formed, said region separating a first and a second inclined guide region, and two end regions, in which the sliding means rest in a first armed position of dose injection and, respectively, after sending the second dose.
    [00013] According to another aspect of the present invention, the directing means comprises portions of axial legs configured to act on the gliding means to move them from the first armed dose injection position and subsequently from the second dose injection armed position following the corresponding axial movements of the targeting means. In particular the directing means comprises a triggering slide movably arranged between the outer housing and the inner housing and projecting from the other end of the outer housing, and second elastic means are provided between a syringe assembly and the cocking to keep the latter protruding out of the outer housing.
    [00014] Preferably, the triggering slide comprises two pairs of diametrically opposed axial leg portions to cause a first displacement and respectively a second displacement of the sliding means. In one embodiment of the present invention the arms have an inclined profile and a length substantially equal to that of the first inclined region and, respectively, the second inclined region of the guide means.
    [00015] Additional features of the autoinjector device according to the present invention are determined in the appended claims. Brief description of the drawings
    [00016] Additional features and advantages of the autoinjector device according to the present invention will be apparent from the following description of a non-limiting and exemplary modality thereof with reference to the accompanying drawings, in which:
    [00017] Figure 1 is a general side view of the autoinjector device according to the present invention, shown separated from its protective sheath;
    [00018] Figure 2 is the simplified exploded view of the autoinjector device according to the present invention;
    [00019] figure 3 is a longitudinal sectional view of the autoinjector device according to the present invention taken along lines III-III of figure 1;
    [00020] Figure 4 is a longitudinal sectional view of the device for arming the autoinjector according to the present invention;
    [00021] figure 5 is an axial view in the direction of arrow A of figure 4 (cover removed) of the autoinjector device according to the present invention;
    [00022] Figure 6 is the perspective view of a syringe assembly mounted on the autoinjector device according to the present invention;
    [00023] Figure 7 is a partial side view of the autoinjector device according to the present invention with the parts removed for clarity;
    [00024] figures 8a and 8b show, in two perspective views axially rotated by 90°, a tubular member of the autoinjector device according to the present invention;
    [00025] Figure 9 is the perspective view of a syringe holder of the autoinjector device according to the present invention;
    [00026] figures 10a, 10b and 10c show, in two longitudinal views axially rotated by 90° and a perspective view, the internal housing of the autoinjector device according to the present invention;
    [00027] figures 11 to 22 show the operational steps of the autoinjector device according to the present invention. Detailed description of the present invention
    [00028] With reference to figures 1 and 2, the autoinjector device according to the present invention comprises an external housing 1, having a tubular shape and equipped with a cap-shaped button 3 at one end, while the tapered end of a trigger slider 30, internally of outer housing 1, protrudes from the other end. The tapered end is closed by a needle cover 41 and an inner needle guard 42 which sits directly over the needle is housed in the needle cover 41. The needle cover 41 and needle guard 42 are easily removable when using the device. must be used so as to expose the needle ready for injection of the first dose. The autoinjector is additionally provided with a protective sheath 40 which rests on the outer housing 1 when the device is in a storage state.
    [00029] Referring also to figures 3 and 4, the outer housing 1 extends over a longitudinal axis X between an open (or distal) end and a closed (or proximal) end, having a closing wall 1a, in which two diametrically opposed arch grooves 2 (only one shown in figure 5) are formed each having an angular extent of, for example, about 90°. The outer housing 1 additionally has an end portion 1b at its closed end having a smaller diameter and defining a surface that acts as a base for the cap-shaped knob 3. Two pins 4 engaging with grooves 2 extend from the side bottom of button 3. Button 3 is mounted coaxially to outer housing 1 and is pivotable to end portion 1b of outer housing 1 and the extent of its angular displacement clockwise or counterclockwise depends on the angular extent of slots 2 .
    [00030] The rod 3a extends from the button 3 parallel to the longitudinal axis X along the outer housing 1. The rod 3a serves as a pointer to indicate the current operating condition of the autoinjector device (stored state, first cockable state, i.e. , ready for first injection, second cockable state, ie ready for second injection) in combination with as many corresponding reference marks 5 (eg consisting of reference numerals 0, 1, 2) arranged in a circumferential line on the surface of the outer housing 1.
    [00031] A portion 1c of the outer housing 1, extending from its open end, is formed with an inner diameter larger than the remainder of the outer housing 1, whereby a circular step 6 is formed between the two parts . Two diametrically opposite slits 7 are formed in the same portion 1c near the step 6, while two additional diametrically opposite slits 8 are formed near the open end of the outer housing 1.
    [00032] A side wall of the end portion 1b of the outer housing 1 is formed with two diametrically opposite side grooves 9 and two tabs 10 protruding from the side surface of a tubular member 11 engage therewith. The tubular member 11 is open at its distal end and closed by a wall 11a at its proximal end. Referring also to Figures 5, 8a and 8b, the tubular member 11 is coaxially engaged within the outer tubular housing 1 and the wall 11a is formed with two holes 12 for a fixed connection with the ends of the two button pins 4 passing through the arcuate grooves 2, with which the tubular member 11 is integral with the button 3 and can be displaced angularly therewith, but cannot slide axially by virtue of the folded tabs 10 engaging with the lateral grooves 9 of the outer housing 1.
    [00033] Two diametrically opposed circumferential slits 13 are formed on the side surface of the tubular member 11 in an intermediate position and respective direct guides 14 extend diagonally along the side surface of the tubular member 11 towards the distal end thereof, each with an angular extension of about 90°. The two direct guides 14 have equal inclination but are symmetrically opposite with respect to the longitudinal axis X.
    [00034] The two direct guides 14 are each formed by a first and a second inclined region 14a and 14b separated by an intermediate step 14c that lies in a plane orthogonal to the longitudinal axis X and an end region 14d extending longitudinally to from the end of the second region 14b to the open end of the tubular member 11.
    [00035] The first inclined region 14a of the direct guides 14 starts from an intermediate position of the respective circumferential slots 13 and thus defines two slot parts 13a and 13b arranged on the right side and on the left side of the first region 14a. A flap 15, the function of which will be explained later, extends outwardly from the underside of the slit portion 13b near the first region 14a.
    [00036] A tubular-shaped inner housing 16 with open ends, shown in detail in Figures 10a, 10b and 10c, is coaxially housed in the tubular member 11. Two diametrically opposed longitudinal grooves 17 are formed in the inner housing 16 and at least one cut. longitudinal 18, serving as a viewing window for the drug extends from the distal end of the drug. Two radial teeth 19 extend outwardly from the inner housing 16 to engage within the slots 7 of the outer housing 1, preventing the inner housing 16 from moving linearly and rotationally with respect to the outer housing 1. A pair of radial projections 20 se extend from inner housing 16 to rest against step 6 (see figure 4) of outer housing 1 to further prevent any axial movement.
    [00037] Referring to figure 6, a syringe assembly S is shown therein. The set comprises a syringe 21 with a needle 22 at its distal end. The syringe is housed in a tubular holder 23, also shown in Figure 9, open at its ends and having an intermediate flare 23c engaging against the distal end of the inner housing 16, in which the tubular holder 23 is partially housed. A window 23d is formed in the tubular support 23 and is aligned with longitudinal section 18 of inner housing 16 to produce syringe contents visible from the outside.
    [00038] The tubular support 23 is formed with bent edges 23a at its distal end against which the distal end of the syringe rests, while two opposing radial projections 23b are formed at another end on which a flange 21a of the syringe 21 rests.
    [00039] The two radial projections 23b of the tubular support 23 are further configured to be slidably engaged within the longitudinal slots 17 of the inner housing 16 to allow the tubular support 23 to axially move to an adjusted extension, with which the syringe is housed. with it is correspondingly moved.
    [00040] Two slanted guides 24 are formed on the wall of the inner housing 16 in diametrically opposite parts, said guides being slanted with respect to the longitudinal axis X, but not incident to it, as they are formed on the lateral surface of the inner housing 16. In particular, as shown in Figures 10a and 10b, each inclined guide 24 comprises a first and a second ramp 24a and 24b separated by an intermediate region 24c and ending with two end regions 24d and 24e formed at the beginning of the first ramp 24a and, respectively, at the end of the second ramp 24b. The first ramp 24a has a greater length than the second ramp 24b. The inclined guides 24 have equal inclination and a substantially equal extent to the direct guides 14 of the tubular member 11.
    [00041] Within the syringe 21 a plunger stop 25 is slidably and sealably housed and is connected to the end of a plunger 26 axially sliding within the inner housing 16. In particular the plunger 26 has an enlarged intermediate portion 26a of a shape substantially cylindrical and diameter substantially equal to the inner diameter of the inner housing 16 so as to maintain the plunger in axial alignment with the inner housing 16 as it slides thereon.
    [00042] As shown in figure 6, at the end opposite that bearing the stop 25 the piston 26 has an axial rod 26b with an injection spring 27 arranged around it and disposed between the wall 11a of the tubular member 11 and the plate cam 28 coaxially and slidably mounted on rod 26b and disposed close to flare 26a of plunger 26. Injection spring 27 is mounted in a compressed state between wall 11a and cam plate 28 and is therefore pre-filled when the device is in a storage sleep condition.
    [00043] Two slide pins 29 extend radially from the cam plate 28 on diametrically opposite sides thereof and are configured to be on the tabs 15 of the tubular member 11 when the device is in the resting or storage condition and to be able to slide on the respective slanted guide 24 of the inner housing 16.
    [00044] The inner housing 16, which houses a syringe holder 23 and the syringe 21 therein, both slidable in the axial direction, is arranged on the trigger slider 30 which is formed with the tapered end from which the syringe needle 22 extends when the device is used. The syringe holder 23 projects from the inner housing 16 starting from its intermediate flare 23c, which is provided with an essentially cylindrical shape and a diameter substantially equal to the inner diameter of the trigger slider 30 to allow relative sliding while holding the axial alignment.
    [00045] The recoil spring 31 is disposed between the intermediate flare 23c of the syringe holder 23 and the tapered end of the trigger slider 30 so as to keep the syringe holder 23 oriented against the end of the inner housing 16. trigger slider 30, near its tapered end, extend two diametric teeth 32 (only one visible in figure 1) which slidingly engage in slots 8 of outer housing 1, whereby trigger slider 30 is allowed to slide axially over a distance equal to the length of the slots 8 with respect to the outer housing 1.
    [00046] The other end (the proximal end) of the trigger slider 30, which has a substantially tubular shape, is arranged between the outer housing 1 and the tubular member 11 and is configured in the shape of leg portions, which in the present embodiment of the present invention, are formed with inclined profile having substantially the same inclination as that of the inclined guides 24 formed in the inner housing 16. In particular, as shown in figure 7, starting from said end the trigger slider 30 is formed with two diametrically opposed longitudinal cuts 30a defining two tubular surface portions each delimited by a first side coinciding with the generator of the tubular trigger slider and a second side inclined with respect to said generatrix. The sloped side of each tubular surface portion is formed by a long leg portion 36, starting from the proximal end of the trigger slider 30, and the short leg portion 37 separated by a recess 38.
    [00047] When the autoinjector is operated, the slide pins 29 of cam plate 28 coaxial to the piston rod 26b slidably engage, as stated above, in the respective inclined guides 24 of the inner housing 16 passing through the direct guides 14 of the tubular member 11 and bearing against the slanted profiles of the respective long and short leg portions 36 and 37 of the trigger slider 30.
    [00048] In short, the button 3 and the tubular member 11 are integral with each other and pivotable with respect to the outer housing 1 and the tubular member 11 is incapable of sliding axially with respect to it. The inner housing 16 is fixed with respect to the outer housing 1 and therefore is incapable of moving linearly and rotationally with respect thereto. Trigger slider 30 is axially slidable with respect to outer housing 1, but cannot rotate with respect thereto, and syringe holder 23 is axially slideable on inner housing 16 and trigger slider 30 against recoil spring 31. The plunger 26 is axially slidable in the inner housing 16 under the action of the injection spring 27 once it is cocked. Once the inner housing 16 is secured to the outer housing 1, sliding of the slide pins 29 on the slanted profiles of the leg portions 36 and 37 and into the slanted guides 24 of the inner housing 16 causes the syringe holder 23 and the plunger 26 moves axially.
    [00049] The operation of the autoinjector device according to the present invention is now described with reference to figures 11 to 22.
    [00050] In the stored condition, the injection spring 27 is in a fully compressed state between the wall 11a of the tubular member 11 and the cam plate 28, as shown in figure 3. The slide pins 29 of the cam plate 28 are found on the bent flaps 15 of the tubular member 11, thereby securing the injection spring 27 in place (figure 11). This avoids the deformation of the mechanism in a medium to long term storage period. The rod 26a of the plunger 26 also helps to prevent the compressed injection spring 27 from skewing. The tubular member 11 is connected to the outer housing 1 via protruding tabs 10 secured in the grooves 9 to allow rotation and prevent translation of the tubular member 11 with respect to the outer housing 1 when the knob 3 is turned.
    [00051] The inner housing 16 rests on the tubular member 11 and is fixed to the outer housing 1 by teeth 19 and projections 20 preventing them from rotating or translating with respect to each other.
    [00052] The holder 23 of the syringe 21 is seated on the trigger slider 30 and slidably engages its radial projections 23b in the longitudinal slots 17 of the inner housing 16. The length of said slots defines how far the syringe holder 23 can fit. move what actually determines the distance of the needle extension.
    [00053] Once the protective sheath 40 is removed, to perform the first automatic injection the user must remove the needle cap 41 from the tapered end of the trigger slider 30. In this step, the needle is uncovered but remains relatively flush inside the tapered end of the trigger slide.
    [00054] To arm the device for the first dose, the user must turn the cap-shaped knob 3 by an adjustment angle. Twisting knob 3 from position 0 (stored state) to position 1 (first dose cocked state) causes tubular member 11 to rotate at a corresponding adjustment angle as it is integrally connected to the button 3 (figure 12), and the alignment of the first slanted region 14a of the direct guides 14 to the first ramp 24a of the slanted guides 24. Said action causes the slide pins 29 of the cam plate 28 to fall from the tabs 15 of the tubular member 11 over the first respective regions 24d of the slanted guides 24 of the inner housing 16, thereby allowing the injection spring 27 to decompress a small adjusted distance. In this step, no other components change position or orientation. The device is now armed and ready to be triggered by the user.
    [00055] The device is triggered by the user to press the tapered end of the trigger slider 30 against the injection field (figure 13). Depressing trigger slider 30 forces the component to move within outer housing 1 toward the opposite end. This causes the ends of the long leg portions 36 of the trigger slider 30 to exert a lateral force against the slide pins 29 of the cam plate 28, which rotate around the rod 26b to arrange the pins 29 in alignment with the first. ramp 24a of the inclined guides 24 of the inner housing 16 (figure 14), whereby said pins 29 are free to slide on the first ramp 24a under the action of the injection spring 27.
    [00056] Once cocked, the injection spring 27 is free to decompress and thus forces the cam plate 28, the plunger 26 and the syringe 21 forward, i.e., towards the distal end of the outer housing 1 (figure 15). Said movement also causes the syringe needle 22 to penetrate the injection field at a depth governed by the length of the longitudinal grooves 17 guiding the syringe holder 23 into the inner housing 16. So that said movement can occur, the hydrostatic force required to expel the drug from the syringe needle must be greater than the sum of the frictional forces to propel an S syringe assembly forward to the specified depth of the injection needle.
    [00057] Once the syringe needle 22 reaches the full injection depth (figure 16), the injection spring 27 continues to decompress pushing the cam plate 28 and plunger 26 forward with respect to the syringe barrel and making with the first dose of medicine being expelled from the syringe.
    [00058] It is worth noting that the cam plate 28, while moving axially, rotates around the rod 26a of the piston 26, as the slide pins 29 are prevented from sliding on the inclined guides 24 It is also worth noting that the length of the ramp 24a of the slanted guides 24 is such as to allow not only the sliding of the syringe holder 23 to make the needle penetrate the skin, but also the sliding of the plunger 26 to send the first dose of drug.
    [00059] The shipment of the first dose is complete once the slide pins 29 reach the intermediate region 24c of the slanted guides 24 in the inner housing 16 and the recess 38 of the trigger slider 30 (figure 17). As region 24c prevents injection spring 27 from decompressing further and engagement with recess 38 prevents slide pins 29 from turning further, no more medicine will be expelled.
    [00060] After sending the first dose, the user removes the device from the injection field. Once pressure on the tapered end of trigger slide 30 ceases, recoil spring 31 moves forward of the tapered end reducing the length of the exposed needle. By virtue of said sliding of the trigger slider 30, the slide pins 29 protrude from their respective recesses 38, while being barred in regions 24c of the guide 24, as shown in Figure 18. Then the user repositions the device in the protective sheath 40 to avoid any damage and accidents with the needle and wait the prescribed time to decide if a second dose is needed.
    [00061] If a second dose is required, the user must first remove the protective sheath 40 from the device in order to access the needle and then arm the device to prepare the same for sending the second dose. For this purpose the user must turn the cap-shaped knob 3 at a preset angle. Turning knob 3 from position 1 to position 2 (second dose injection armed state) causes tubular member 11 to rotate at an adjustment angle. In this way the second inclined region 14b of the direct guides 14 is aligned with the ramp 24b of the inclined guides 24 and the slide pins 29 move along the intermediate region 24c until reaching the position ready to be cocked (figure 19).
    [00062] The device is triggered by the user pressing the tapered end of the trigger slider 30 against the injection field and causing the trigger slider to move towards the opposite end of the outer housing 1. The end of the short leg portions 37 of the trigger slider 30 contacts the respective slide pin 29 and displaces it laterally in the intermediate region 24c until bringing it into alignment with the second ramp 24b of the angled guide 24 in the inner housing 16, thus allowing the pins slides 29 move freely on the respective second ramps 24b (figure 20) under the action of the injection spring 27 which presses additionally. In this way an additional sliding of the cam plate 28 and the plunger 26 with respect to the syringe barrel is brought about in order to expel the medication from the syringe, i.e. the delivery of the second dose. It is worth noting that since the needle remains exposed from the first dose onwards, there is no need to push a syringe assembly forward and therefore a shorter length of the second ramp 24b relative to the first ramp 24a is required.
    [00063] The shipment of the second dose is complete once the slide pins 29 reach the end region 24 and the slanted guides 24 in the inner housing 16 (figure 21). Because the end region 24e prevents the injection spring 27 from decompressing further, no further medicine will be expelled.
    [00064] After sending the second dose, the user removes the device from the injection field. As pressure on the tapered end of trigger slide 30 ceases, recoil spring 31 moves forward of the tapered end (Fig. 22). Finally, the user re-sheaths the device for safe disposal.
    [00065] The tubular member 11 is preferably made of metallic material to provide adequate protection for the syringe and to ensure long-term storage of the device, as it is not prone to deformation to the same extent as the other components. of the molded device.
    [00066] The autoinjector device according to the present invention is capable of sending drugs in solution, especially epinephrine (also known as adrenaline).
    [00067] In particular, the doses of epinephrine that can be administered with the device of the present invention are preferably in the range of 0.05 mg to 0.5 mg for each sent dose (from 0.1 mg to 1 mg if two doses are considered).
    [00068] Preferred doses for each shipment are 0.05mg, 0.10mg, 0.15mg, 0.30mg and 0.50mg.
    [00069] The above doses are based on the concentration of the epinephrine solution. Preferably ranging from 0.05 mg/ml to 0.5 mg/ml, the concentrations 0.05 mg/ml, 0.1 mg/ml, 0.16 mg/ml, 0.3 mg/ml and 0 .5 mg/ml being particularly preferred.
    权利要求:
    Claims (18)
    [0001]
    1. Medicine injector device comprising a syringe assembly (S) containing the medicine to be injected, said assembly being coaxially and slidably arranged in an outer housing (1) extending along a longitudinal axis (X), and means for arming the device (3, 11) from a rest position to a first dose injection armed position and to a second dose injection armed position, said arming means being arranged at one end of said outer housing (1), first elastic means (27) being provided between said syringe assembly (S) and said cocking means (3, 11), said first elastic means being in a compressed state when the device is in the rest position, device directing means (30) being further provided to control the sliding of said syringe assembly (S) from said armed position to inject an needle. ha of syringe (22) in an injection field and send the first dose and, if necessary, send the second dose in a subsequent preset time, characterized by the fact that the syringe assembly (S) comprises sliding means (28, 29) engaged in stepped guide means (24), said guide means (16, 24) being inclined, but not incident, with respect to the direction of the longitudinal axis (X) and axially integral to said outer housing (1), said sliding means (28, 29) and said guide means (16, 24) being pivotable with respect to each other about the longitudinal axis (X), said directing means (30) being able to slide axially as a result of separate and successive pressures against said injection field to promote a first relative displacement of said sliding means (28, 29) from said first dose injection armed position to a position in alignment with said means. guide (16, 24), with which I referred them of the slide means (28, 29) can freely move along the guide means to a first stop position (24c), and a second relative displacement of said slide means (28, 29) from said second position dose injection armature to a position in alignment with said guide means (16, 24), whereby said slide means (28, 29) can freely move along the guide means to a second position of stop (24e).
    [0002]
    2. Injector device according to claim 1, characterized in that said sliding means (28, 29) are axially pivotally mounted on said syringe assembly (S) and said guide means (16, 24) are rotationally integral with said outer housing (1).
    [0003]
    3. Injector device according to claim 1 or 2, characterized in that said guide means comprise an internal housing (16), in which a guide rail (24) is formed, said guide rail comprising an intermediate region (24c) separating a first and a second ramp (24a, 24b) from said guide rail and two end regions (24d, 24e) in which said sliding means (28, 29) bear on said first dose injection armed position and after sending the second dose.
    [0004]
    4. Injector device according to claim 3, characterized in that the first ramp (24a) of said guide rail has a length greater than the second ramp (24b) of said guide rail (24).
    [0005]
    5. Injector device according to any one of the preceding claims, characterized in that said directing means (30) comprises portions of axial legs (36, 37) configured to act on said sliding means (28, 29) to move it from said first dose injection armed position and subsequently from said second dose injection armed position as a result of respective axial movements of said directing means (30).
    [0006]
    6. Injector device according to any one of the preceding claims, characterized in that said syringe assembly (S) comprises a syringe (21) resting on a syringe holder (23) axially sliding with respect to said housing external (1), said syringe (21) comprising a needle (22) and a plunger (26) slidably and sealably engaged thereto and extending from the syringe with an axial rod (26a) in which said means sliders (28, 29) are fitted.
    [0007]
    7. Injector device according to claim 6, characterized in that said sliding means (28, 29) are pivotally mounted on said rod (26a) of said piston (26).
    [0008]
    8. Injector device according to any one of the preceding claims, characterized in that said sliding means comprise a cam plate (28) with two sliding pins (29) radially projecting on diametrically opposite sides to engage with said guide means (16, 24), said first elastic means comprising a compression spring (27) coaxial with said rod (26a) between said plate (28) and said means for arming device (3, 11 ).
    [0009]
    9. Injector device according to any one of the preceding claims, characterized in that said directing means comprises a trigger slider (30) slidable between said outer housing (1) and said inner housing (16) and projecting from the other end of the outer housing (1), second elastic means (31) being provided between said syringe assembly (S) and said trigger slider (30) to maintain the latter in a projected condition from of said external housing (1).
    [0010]
    10. Injector device according to claim 9, characterized in that said trigger slide (30) comprises a first pair of diametrically opposed axial leg portions (36) and a second pair of diametrically opposite axial leg portions (37) to promote the first and, respectively, the second displacement of said sliding means (28, 29).
    [0011]
    11. Injector device according to claim 10, characterized in that the axial leg portions (36) of said first pair of leg portions are longer than the axial leg portions (37) of said second pair of leg portions and are configured with an inclined profile in a manner equal to that of said first ramp (24a) and, respectively, of said second ramp (24b) of said guide rail (24).
    [0012]
    12. Injector device according to claim 11, characterized in that an inclined profile of the long leg portion (36) and an inclined profile of the short leg portion (37) extend one after the other and a recess ( 38) is formed therebetween to engage the respective slide pin (29) at the end of its path along the first ramp (24a) of said guide rail (24).
    [0013]
    13. Injector device, according to any one of the preceding claims, characterized in that said arming means device comprises a button (3) pivotally mounted on said outer housing (1) and a tubular member (11) integral to the said button (3) and extending between said outer housing (1) and said inner housing (16) coaxially thereto, a pair of diametrically opposed direct guides (14) being formed in said tubular member (11) having equal inclinations those of said guide rails (24) and extending from circumferential slots (13) which lie in a plane orthogonal to the longitudinal axis, each of said direct guides comprising two inclined regions (14a, 14b) having the same length whereas that of said first and second ramp (24a, 24b) of said guide rails (24), a step (14c) being formed between them corresponding to the intermediate region (24c) of said rail guide hos (24).
    [0014]
    14. Injector device according to claim 13, characterized in that said circumferential slots (13) are formed with respective protruding tabs (15) in which the slide pins (29) meet when the device is in position rest.
    [0015]
    15. Injector device according to claim 13 or 14, characterized in that angularly spaced reference markings (5) are provided on said outer housing (1) corresponding to said rest position and said first injection armed position and second dose injection armed position and a pointer (3a) extends from said button (3), said pointer (3a) being alignable with each of said reference markings (5) as a result of a predefined angular displacement of said button (3).
    [0016]
    16. Injector device according to claim 13 or 14, characterized in that said tubular member (11) is made of metal.
    [0017]
    17. Injector device according to any one of the preceding claims, characterized in that at the end of said trigger slider (30) extending from said outer housing (1) a removable cap (41) is provided for the needle guard (22).
    [0018]
    18. Injector device according to any one of the preceding claims, characterized in that the removable protective sheath (40) is provided in said outer housing (1) at the end where said trigger slider (30) protrudes from the same.
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    同族专利:
    公开号 | 公开日
    JP2013521850A|2013-06-13|
    IT1398501B1|2013-03-01|
    CN102917742A|2013-02-06|
    JP5715165B2|2015-05-07|
    ES2553569T3|2015-12-10|
    ITFI20100033A1|2011-09-11|
    RU2012143153A|2014-04-20|
    MX2012010339A|2012-11-12|
    MX339182B|2016-05-16|
    CA2791163A1|2011-09-15|
    CN102917742B|2014-12-10|
    EP2544740A2|2013-01-16|
    US20130046238A1|2013-02-21|
    PL2544740T3|2016-02-29|
    US8961463B2|2015-02-24|
    CA2791163C|2017-11-21|
    EP2544740B1|2015-09-02|
    WO2011111006A3|2011-11-24|
    RU2555114C2|2015-07-10|
    AR080391A1|2012-04-04|
    BR112012022471A2|2020-09-01|
    WO2011111006A2|2011-09-15|
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    法律状态:
    2020-09-15| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-02-09| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|
    2021-05-18| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-06-29| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 09/03/2011, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, , QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO. |
    优先权:
    申请号 | 申请日 | 专利标题
    ITFI2010A000033A|IT1398501B1|2010-03-10|2010-03-10|AUTOINECTOR DEVICE FOR TWO DRUG DOSES|
    ITFI2010A000033|2010-03-10|
    PCT/IB2011/050985|WO2011111006A2|2010-03-10|2011-03-09|Device for the automatic injection of two doses of a medicament|
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