巴西专利BR112014005391B1 AUTOMATIC MEDICINE INJECTION DEVICE

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专利摘要:
device for automatic injection of two doses of a medicine. a device for automatic injection of doses of a drug is described, comprising a sliding element (30) and cam devices (23, 28, 36), a syringe unit (6) with a piston (8), and guide devices ( 26), the axial movement of the sliding element initiated by the user by pressing its front end against the injection site causes the angular displacement of the cam device which, in cooperation with the guide device, controls the movement of the syringe piston and therefore , the administration of a dose of drug.
公开号:BR112014005391B1
申请号:R112014005391-0
申请日:2012-09-06
公开日:2020-09-24
发明作者:Mark Jeffrey Edhouse；Philip Jerome Driver；Guy Conwyn Julian Moseley；Scott Alexander Lewis
申请人:Menarini International Operations Luxembourg S.A.；
IPC主号:

专利说明:

[0001] [0001] The present invention generally relates to devices for the injection of medications and more precisely it relates to a device for the automatic injection of medications especially a medication for allergic emergencies, such as epinephrine or adrenaline, according to a time sequence requested. In particular, the invention relates to a device for the automatic injection of two doses of a drug at two successive times. Fundamentals of the Invention
[0002] [0002] Many devices of the type mentioned above allowing a patient to self-administer one or more doses (usually two) of a drug are known. U.S. 6,575,939 describes an autoinjector device comprising a syringe housed in a wrapper formed by an inner and an outer part capable of sliding with respect to each other. By pressing the end of the inner part (the needle outlet end) against the patient's skin at the injection site, the outer part slides forward along the inner part, thus unlocking a push button. By pressing the button, the syringe and the relevant plunger are activated for the first push in the needle and then dispenses the medication. The retraction of the needle in the wrap is achieved by interrupting the pressure of the outer edge against the skin. This autoinjector allows a single dose of the drug to be administered.
[0003] [0003] An auto-injector device for automatic administration of a single dose of a drug is also known from U.S. 4,031,893. The autoinjector is equipped with an unlocking device with a deformable element for the drive device. The syringe plunger is axially connected to a rod comprising four flexible axial arms having a toothed end engaged on the edge of an opening formed in a cap located at the end of the syringe housing. Sliding the cover causes the ends of the arms to deform and their teeth to be released from the opening edge. In this way, the drive device is activated. The autoinjector according to this document also comprises a safety device to prevent accidental deformation of the extremities of the arm and the activation of the actuation device, consisting of an insert extending centrally from the cover and capable of entering between the arms of stem to prevent them from bending.
[0004] [0004] EP 700 307 describes a two-dose autoinjector allowing automatic delivery of a first dose of a drug and manual administration of a second dose. The autoinjector device according to this patent envisages the use of a syringe housed slidingly in a tubular housing in two parts that can be separated to allow the positioning of the syringe containing two doses of medicine to be distributed and the removal after use. The slide of the syringe into the housing to penetrate the needle and inject the medication is operated by a mobile actuator between an armed position and an extended position. A releasable locking device is provided to limit the syringe plunger by sliding to an extent corresponding to the volume of the first dose. The syringe is movably mounted in the tubular housing to allow the locking device to be removed after the first dose is dispensed and the plunger drive device to be cocked again, if the second dose is administered automatically, or the syringe is removed , if the second dose is administered manually. In addition, the drive device is provided with a safety lock formed by an element engaging the deformable pin of the drive device to keep it in a deformed condition, thus preventing it from activating. Such an autoinjector is commercially available under the trademark Twinject® and allows the first dose to be administered automatically, but the second dose must be administered manually.
[0005] [0005] The autoinjector according to EP 651 662 is designed to perform a sequence of injections from a single syringe that is capable of making limited sliding movement in a tubular housing. The syringe has a plunger to distribute doses of a medicine through the needle and the triggering device by mole engages with a piston rod and, once they are armed, retain the rod in a first position, while, when they are activated, they make the stem moves forward and this causes the syringe to slide first and the needle protrude and then a controlled slide of the plunger to deliver a dose of medicine. Manual arming devices are provided and it means restarting the spring-loaded device.
[0006] [0006] The plunger rod has a toothed profile in which a lock on the actuation device engages and the syringe is housed in a bushing capable of limited movement in the tubular housing and provided with an additional lock which is also engaged with the profile toothed stem. When the device is armed by the manually arming device, both the drive device and the sleeve on which the syringe is located are moved towards the rear end of the tubular housing, the two latches engaging with the toothed profile of the stem. An axial groove connection between the bushing and the drive device allows for additional sliding between the integral lock on the drive device and the toothed profile to an extent equal to the profile slope. When the device is actuated, first the actuation device causes the syringe bushing to slide to a front stop and then the stem begins to slide with respect to the bushing lock for an extension corresponding to the profile inclination, where the displacement of a drug volume is activated along with its distribution through the needle.
[0007] [0007] There is a strong need for an injection device for the automatic injection of a drug in two successive doses that are easy for the user and easier to manufacture compared to conventional devices. The subject of the present invention is, therefore, to meet these requirements by providing an auto-injector drug device capable of allowing the patient to self-administer at least two successive doses of a drug in the easiest possible way, saving the patient from performing new operations. complex and potentially dangerous configuration / disassembly. Summary of the Invention
[0008] [0008] The general subject of the present invention is whether to provide a device for the automatic injection of multiple discrete nominal volumes of a drug compound, in particular two doses of drug compound from the same syringe.
[0009] [0009] A particular subject of the present invention is whether to provide a device of the type mentioned above in which automatic injection of the discrete nominal volumes of the drug product is achieved by a combination of rotational and translational movements of the device components.
[0010] [0010] An additional subject of the present invention is to provide a device of the type mentioned above in which the automatic injection of a prescribed dose is triggered by the use of a linear slide of a component activated by the patient, in combination with the angular displacement of the device. plunger being guided by cam devices in an encapsulated chassis.
[0011] [0011] It is additionally a subject of the present invention to provide a device of the type mentioned above with an automatic protection lock accessory for needle protection and prevention of inadvertent activation of the device before a dose is selected by the user.
[0012] [0012] Another additional subject of the present invention is the provision of a device of the type mentioned above capable of automatically protecting the needle again and reconfiguring the locked condition after a dose is injected.
[0013] [0013] It is another additional matter of the present invention to provide a device of the type mentioned above in which the user needs to apply a determined force to expose the needle, but, after that, a quick insertion of the needle into the patient is aided.
[0014] [0014] An additional subject of the present invention is whether to provide a device of the type mentioned above in which the steps necessary for the user to initialize the device are minimized, in particular limited to the rotation of only one component to activate the delivery of a dose of drug .
[0015] [0015] The above subjects are achieved with the device for the automatic injection of doses of a medicine according to the present invention, the main characteristics of which are presented in claim 1 in annex. Additional important features are presented in the dependent claims.
[0016] [0016] According to an important aspect of the device for automatic injection of doses of a drug according to the present invention, the axial movement of a sliding element, caused by the user by pressing its front end against the injection site, causes an angular displacement of the cam device, which, in cooperation with the stepped guiding device, controls the movement of the plunger device of a group of syringes and thus the distribution of preset doses of the drug. The movement of the plunger device is produced by the axial operation of the first elastic device, while the axial movement of the sliding sheath is hindered by the second elastic device which reiterates the initial needle cover condition of the slider when the pressure action stops. To make the device ready for dispensing a dose, the arming device is provided and, when operated, unlocks the axial sliding movement. The locking condition, in addition to the needle retraction in the sliding element, are automatically reiterated when the pressure ceases under the action of the second elastic device.
[0017] [0017] According to another important aspect of the invention, the guide device for the plunger device is formed in an internal body integral to the external body of the device and the cam device for driving the device is formed in a transmission sleeve interacting with the sliding element on one side and with the inner body and the selection sleeve on the other side. Thus, a sliding movement results in a sliding and an angular displacement of the transmission sleeve driven by the internal body for the distribution of the first dose and by the selection sleeve for the distribution of the second dose. Brief Description of Drawings
[0018] [0018] Additional features and advantages of the autoinjector device according to the invention will be apparent from the following description of an illustrative non-limiting modality with reference to the attached drawings, in which:
[0019] [0019] Figure 1 is an overview of the autoinjector device according to the present invention;
[0020] [0020] Figure 2 is a perspective view, partially exploded of the device of Figure 1;
[0021] [0021] Figure 3 is a fully exploded view of the device in Figure 1;
[0022] [0022] Figure 4 is a longitudinal section of the device of Figure 1;
[0023] [0023] Figure 5 is a longitudinal section of the device of Figure 1 taken along the lines V-V of Figure 4;
[0024] [0024] Figure 6 is an enlarged exploded view of the device of Figure 1, some parts being removed for the sake of clarity;
[0025] [0025] Figure 7 is a perspective view of the dose selection button of the device of figure 1;
[0026] [0026] Figure 8 is an axial section of the dose selection button in Figure 7;
[0027] [0027] Figure 9 is an overview of the syringe unit inside the device of figure 1;
[0028] [0028] Figure 10 illustrates the selection button mounted on the piston rod;
[0029] [0029] Figure 11 illustrates the piston rod in an upward perspective view;
[0030] [0030] Figure 12 illustrates the front part of the device, parts being removed for clarity purposes;
[0031] [0031] Figure 13 is an axial section of the front of Figure 12;
[0032] [0032] Figure 14 is an upward perspective view of the front of Figure 12;
[0033] [0033] Figure 15 illustrates the device in its stored state;
[0034] [0034] Figure 16 illustrates the device armed for the first dose and ready to activate;
[0035] [0035] Figure 17 illustrates the device at the beginning of the distribution stage of the first dose;
[0036] [0036] Figure 18 illustrates the device at the end of the distribution stage of the first dose;
[0037] [0037] Figure 19 illustrates the device in the reconfiguration step between the distribution of the first and the second dose;
[0038] [0038] Figure 20 illustrates the device at the moment when it is armed for the second dose;
[0039] [0039] Figures 21 and 22 illustrate the armed device for distributing the second dose in two different views;
[0040] [0040] Figure 23 illustrates the device at the beginning of the second dose distribution stage;
[0041] [0041] Figure 24 illustrates the device at the end of the second dose distribution step. Detailed Description of the Invention
[0042] [0042] With reference to figures 1 to 5, the autoinjector device according to the present invention comprises an outer body 1 of tubular shape, in particular a cylindrical shape, extending along a geometric axis X and containing most of the device components within it. The outer body 1 is closed at its front end by a removable cover 2, while from its rear end, enlarged by a flange 1a, a collar 3 is projected, in which angularly spaced reference marks, in particular, the numbers 0 , 1, 3 are illustrated, indicating a resting state (0) and two operational states (1, 2) of the device, as explained later. In the present description the terms "front", "rear" and equivalents refer to the part of the device intended for the exit of the needle, and, respectively, lie the axially opposite part. It is also mentioned that in the present description reference is always made to a device for the automatic injection of two doses of a drug, but it is understood that the invention also comprises devices capable of delivering more than two doses of a drug in successive moments, through changes and alterations to the device that are obvious to those skilled in the art.
[0043] [0043] A dose selection button 4 in which a reference arrow 5 is illustrated extends from collar 3. Button 4 is axially rotatable with respect to collar 3 to allow arrow 5 to align with the reference illustrated in collar 3.
[0044] [0044] A syringe unit, usually indicated by 6, is housed in the outer body 1 and comprises a syringe pre-filled with drug 7 with the relevant needle 7a, needle guard 7b, plunger 7c and internal plunger stop 7d. A piston rod 8 is axially disposed on the cylinder 7c. The end of the plunger rod is configured to engage with the plunger stop 7d following an axial sliding element to push it forward when the drug is dispensed. The other end of the piston rod 8 extends axially as a tubular housing 9 to retain a piston spring 10 therein. With reference also to figures 4 and 5, the tubular housing 9 extends inside the dose selection button 4 and plunger spring 10 winds around a protrusion 4a extending from a lower face 4b of the button 4, against the which the plunger spring 10 rests. The arrangement of the plunger spring 10 between the inner wall of the tubular housing 9 and the protrusion 4a of the boot 4 helps to minimize the volume of the spring, which in the beginning in a compressed state between the lower face 4b of the button 4 and the bottom of the housing 9.
[0045] [0045] As also illustrated in greater detail in figures 7 and 9, the projection 4a is connected to the tubular housing through a bayonet-shaped connection formed by a substantially T-shaped end of the projection 4a and two diametrically opposite internal supports 9a from tubular housing 9. When the arrow 5 of the button 4 is aligned with the reference mark 0 of the collar 3, the two supports 9a engage with the T-shaped end 4c on opposite sides of the same, oriented against said end by the spring 10 As a result of an axial angular displacement of the button 4, the T-shaped end disengages from the supports 9a and tubular housing 9, and, consequently, the plunger rod 8 is released to slide axially under the action of the spring 10.
[0046] [0046] Two radial pins 11 are formed at the end of the tubular housing 9, from where the piston rod 8 extends, projecting outwards from diametrically opposite parts. The two preachers 11 are designed to slide in a guide channel to trigger the movement of the piston rod 8 controlling the drug distribution, as explained later.
[0047] [0047] Collar 3 constitutes the enlarged end of a plunger sleeve 12, illustrated in particular in figures 10 and 11, coaxial with the plunger rod 8 and integral with the external body 1 through an alignment tooth 13 engaging with a corresponding perimeter partition 14 formed on the internal wall of the external body 1. The dose selection button 4 is integral to a dose selection sleeve 15, coaxial with the external body 1, through a pair of diametrically opposed axial pins 16, which , by passing through the grooves 17 of the plunger sleeve 12, engage with the corresponding recesses 18 formed on the edge of the selection sleeve 15. The selection button 4 is connected to the plunger sleeve 12 in a unidirectional manner rotating through a pair of diametrically opposed axial toothed extensions 19 engaging with a gear ring 20 formed on the inner face of collar 3 and through a pair of retaining clips 21 slidingly engaging in a corresponding annular groove 2 2 also formed on the inner face of the collar 3. The sprocket ring 20 has a profile that allows the angular displacement of the button 4 occurring in only one direction, where the user cannot bring the button back to a previous state.
[0048] [0048] A transfer sleeve 23 is arranged coaxially between the piston sleeve 12 and the dose selection sleeve 15. The transfer sleeve 23 controls the movement of the piston rod 8 for triggering a dose distribution, as will be described later.
[0049] [0049] As shown in figure 4, the plunger sleeve 12 is connected to the syringe 7 through a plunger end flange 7c leaning on a flange 24 projecting internally on the free end of the plunger sleeve 12. To prevent reverse movement of the syringe, the plunger flange 7c is locked against the flange 24 by two syringe retaining clips 25 bent inwardly from the side wall of the plunger sleeve 12. The clips 25 flex outward to allow the syringe unit 6 be inserted into the plunger sleeve 12 and then flex elastically back to the syringe lock position.
[0050] [0050] On the lateral surface of the plunger sleeve 12, guide devices are formed for dose preachers 11 comprising two guide channels 26a, 26b extending longitudinally in diametrically opposite parts and symmetrical with respect to the axial rotation with respect to their shape. As illustrated in figures 10 and 11, each channel is formed with a profiled edge, each profile having a first, second and third linear lengths 27a, 27b, 27c, in particular parallel to the geometric axis X, separated by two projections 27d, 27e , the first linear length 27a starting at the inner base of the collar 3, the third linear length 27c ending with a full support part 27f.
[0051] [0051] As illustrated in figure 6, on the side surface of the transfer sleeve 23, a cam device is formed to drive the dose preachers 11 comprising two cam channels 28a, 28b, extending longitudinally in diametrically opposite parts and symmetrical to the rotation axial with respect to its shape. Each channel is formed with a stepped profiled edge having a profile reverse to the stepped profiled edge of the guide channels 26a and 26b; each profile having a first, second and third linear lengths 29a, 29b, 29c, in particular parallel to the geometric axis X, separated by two unevennesses 29d, 29e, the first linear length 29a starting from an edge 23a of the transfer sleeve 23 , the third linear length 29c ending with a full support portion 29f.
[0052] [0052] The plunger sleeve 12 and the transfer sleeve 23 are mounted in such a way that, when the device is operated for dose distribution, the two guide channels 26a, 26b and the two cam channels 28a, 28b are substantially aligned in a diametrical plane containing the geometric axis X.
[0053] [0053] As illustrated again in figure 6, the transfer sleeve 23 also has a pair of diametrically opposed first dose drive cams 23b and a pair of diametrically opposed second dose drive cams 23c, to interact, in successive moments, with the corresponding guide rail surfaces 12a on the plunger sleeve 12, and, respectively, corresponding to the guide rail surfaces 15c on the plunger sleeve 15, as explained later. In the selector sleeve 15, a pair of diametrically opposed openings 150 is formed with two circumferential sides in which the pair of second dose drive cams 23c slidably engages. The pair of openings 150 leads to a respective pair of openings 151 of substantially triangular shape, with one side extending on one side of the opening 150, while the other, opposite the opening 150, is the guide rail surface 15c.
[0054] [0054] As illustrated in figures 4, 6, 12 and 13, a sliding element 30 is mounted axially on the front end of the outer body 1. The sliding element 30 slides inside the outer body 1 through a linear joint formed by the longitudinal joints 31 formed on the outer surface of the sliding element 30 and corresponding rims 32 formed on the outer body 1, and engaging with each other. A tubular protrusion 33, in which the needle 7a is positioned with the relevant needle guard 7b of the syringe 7, extends axially on the slide element 30. The projection 33 extends from a lower wall 30a of the slide element 30, the face of which external, or front face, indicated in 30b is designed to contact the patient at the injection point.
[0055] [0055] On the opposite side of the lower wall 30a, the sliding element 30 is connected to a cam sprocket 34 which serves as a way to unlock the device ready for injection and then lock it again by retraction after injection, through a series of cam rails. The selector sleeve 15 interacts with the cam sprocket 34, as shown in figures 13 and 14, in particular, two toothed end extensions 15a extend from the selector sleeve 15 and engage with a sprocket ring 34a formed in the inner face of an end flange 34b of cam sprocket 34. The teeth are configured to allow angular displacement in one direction only. The transfer sleeve 23, in turn, has two arms 23c whose free ends rest on the tubular protrusion 33 of the sliding element 33 when the latter is pressed. A return spring 35 is arranged on the sliding element 30 around its projection 33 and rests on the lower wall 30a and against the end of the cam sprocket 34 engaged with the sliding element 30.
[0056] [0056] A cam rail 36 is engraved on the outer surface of cam sprocket 34. Cam rail 36 is repeated four times at an angle equidistant on said surface and is divided into two parts of the cam rail, for purposes of simplicity called upward part 36a, extending to one end of the cam sprocket 34 and inclined with respect to the X axis, and downward part 36b, extending from the same end of the cam sprocket 34 and incident with the part ascending 36a. A pair of diametrically opposed locking pins 37 projecting inwardly on the sliding element 30 is designed to slide on said cam tracks 36. In the resting state of the device, the locking pins 37 rest on a locking edge 36c (figures 4 and 14) extending circumferentially between the end of a descending portion of the cam rail 36b and the beginning of the ascending part of the angularly adjacent cam rail 36a. The descending cam rail 36b also defines a support 36d serving as a final step for locking pins 37.
[0057] [0057] Four flexible tines equidistant 38 project from the lateral external surface of the sliding element 30 and the end edge of the external body 1 and rest against it. The tines 38 have an inclined face in contact with said edge in such a way as to allow the edge to slide on said face, as a result of which the tine flexes inwards leaving the sliding element 30 to slide in relation to the outer body 1. To control the axial sliding of the sliding element 30, stop pins 39 running on the corresponding rails 40 of the outer body 1 are formed at the edge of the cursor 30 aligned with the flexible tines 38. Additionally, the stop pins 39 serve as the final step for the sliding element 30 to prevent the sliding element 30 from escaping from the front of the device, resting on a corresponding stop ring 41 formed along the front edge of the outer body 1.
[0058] [0058] A window body 42 is located between the edge of the end flange 34b of the cam sprocket 34 and the front end of the transfer sleeve 23 and has a central tubular housing 42a located between the extensions of the transfer sleeve 23 for support the barrel 7c of the syringe 7. The window body 42 is made of a transparent material and fits inside a window opening 43 of the external body 1, where the user can check the drug for any degradation before use or a change device status (no dispensed dose, first dispensed dose, second dispensed dose).
[0059] [0059] A spring 44 is provided around the barrel 7c of the syringe 7 to axially separate the plunger sleeve 12 and the transfer sleeve 23. Due to the different diameters of these components, the spring 44 is tapered.
[0060] [0060] A needle guard remover 45 of the needle guard 7b is removably attached to the outer body 1 by pressure retaining pins 45a and has an internal tubular protrusion 45b engaging with the needle guard 7b, where, pulling it if remover 45 before dispensing the first dose, the user can remove needle guard 7b to expose needle 7a ready for dose dispensing.
[0061] [0061] The following is a description of the way in which the autoinjector device according to the invention can be used.
[0062] [0062] In the initial state, the stored state (figure 15) in which the actuation spring 10 is completely compressed between the rear surface 4b of the dose selection button 4 and the inner bottom surface of its tubular housing 9. The type connection bayonet between button 4 and housing 9 holds the actuation spring 10 in compression until the first dose is selected. Needle guard 7b is attached to syringe 7 and needle guard remover 45 is attached to needle guard 7b. The cover 2 is attached to the outer body 1 and the sliding element 30 is prevented from moving axially since the locking pins 37 of the sliding element 30 rest against the locking edge 36c of the cam sprocket 34.
[0063] [0063] The plunger sleeve 12 is connected to the outer body 1 in a way that it cannot move in a rotational or axial manner with respect to the outer body 1 once assembled. The dose selection button 4 is connected to the plunger sleeve 12 in a way that it can rotate only in one direction with respect to it. The direction of rotation is indicated by the numbering on collar 3; that is, the arrow on the dose selection button starts at 0, rotates to 1 when dose 1 is selected, then rotates to 2 when dose 2 is selected.
[0064] [0064] First, the user must slide back and remove the cap 2 from the device in order to expose the needle protection remover 45. The user must locate the cap 2 once the first dose is delivered when the device is not in use. Cap 2 protects the drug from exposure to light and prevents particles from coming into contact with the front face of the device.
[0065] [0065] To perform the first injection, the user must remove the needle protection remover 45, taking the needle protection 7b with it and leaving the needle 7a uncovered, which, however, remains below the leveling of the front face of the sliding element 30. To unlock and arm the drive mechanism for dispensing the first dose, the user simply turns the dose selection button 4 from position 0 (resting position) to position 1 (armed state of first dose).
[0066] [0066] Rotation of the dose selection button 4 causes the plunger spring 10 to start by unlocking the bayonet connection 4c, 9a between the spring protrusion 4a of the button 4 and the tubular housing 9 of the plunger rod 8 unlocking the actuation spring 10. Unlocking the actuation spring 10 causes an initial slip of the piston rod 8 and the two radial pins 11, aligned on the respective channel guides 26a, 26b of the piston sleeve 12, sliding along the same to be driven on the first projection 27d between the first linear length 27a and the second linear length 27b (figure 16). At this stage, the radial pins 11 slide axially without any angular movements, but are prevented from turning since the piston sleeve 12 is integral with the external body 1 and rest on the unevenness 27d until the device is activated.
[0067] [0067] Rotation of the dose selection button 4 also causes rotation in the same direction as the selection sleeve 15 integral thereto and the cam sprocket 34 through the arms 15a with their toothed ends engaged within the sprocket ring 34a of the cam sprocket 34. Rotation of the cam sprocket 34 causes a relative sliding of the locking pins 37 of the sliding element 30 on the supporting edge 36c of the cam sprocket 34 until the pins 37 are actuated at the entrance of the part ascending 36a of the cam rail 36 formed on the side surface of the cam sprocket 34. It has been noted that the dose selection knob 4 cannot be turned beyond position 1 until the slide element 30 has been pressed for the first dose due to the wall 36d which limits the sliding of the locking pins 37 along the support edge 36c
[0068] [0068] In order to activate the device, the user presses the front surface of the sliding element 30 against the injection site, maintaining the device through its external body 1. The pressure of the sliding element 30 causes a resistance to force due to the contrast between the flexible tines 38 of the sliding element 30 and the end of the outer body 1. Thanks to their flexibility and the inclined contact surface the flexible tines 38 result in pressure and deform inwards to allow complete axial depression of the sliding element 30 in the outer body 1 by letting needle 7a protrude into the injection site. The movement subsequently generated by the release of the flexible tubes 38 quickly inserts the needle 7a into the injection site.
[0069] [0069] The axial sliding of the sliding element 30 as a result of the pressure exerted by the user at the injection site causes the cam sprocket 34 to rotate axially in the opposite direction to the inclination of the upward part 36a of the cam rail 36, since the locking pins 37 slide against it. The sliding element 30 is prevented from turning due to the connection with the external body through the linear joint 31, 32. During this movement, the sprocket ring 34a of the cam sprocket 34 rotates in the permitted direction in view of the fact that the sleeve dose selection button 15, engaged with its toothed ends of its arms 15a on the sprocket ring 34a, is prevented from turning since it is connected to the dose selection button 4 through the interface formed by the dose selection feet 16 of the button 4 engaged with recesses 18 of the dose selection sleeve 15. Unidirectional rotation of the dose selection button 4 is achieved via the interface between the gear teeth 20 on the plunger sleeve 12 and the corresponding gear teeth 19 of the button dose selection 4. The teeth on this interface are designed to oppose greater resistance to rotation than between cam sprocket 34 and selection sleeve 15. Therefore, dose selection sleeve 15 remains stationary and the cam sprocket 34 travels through the toothed feet of the dose selection sleeve until the sliding element 30 reaches the final step of its axial sliding.
[0070] [0070] Since the flexible tines 38 of the sliding element 30 deform enough to allow the sliding element 30 to move axially into the outer body 1, the tubular projection 33 on the sliding element 30 contacts the drive extensions 23a of the sleeve transfer 23. This in turn pushes the transfer sleeve 23 towards the rear of the device. During its axial movement (figure 16), the first dose drive cam 23b on the transfer sleeve 23 interacts with the first dose cam rail surface 12a on the plunger sleeve 12, thereby rotating the transfer sleeve 23 As the transfer sleeve 23 rotates, the dose pins 11 on the plunger rod 8 are moved on the first projection 27d of the guide channel 26a, 26b by the first linear length 29a of the cam channel 28a, 28b of the transfer sleeve 23 to the end of which they fall on the second ledge 27e. The diametrical alignment of the cam channel 28a, 28b and the guide channel 26a, 26b allows axial sliding of the dose clamps 11 under the action of the actuation spring 10, as shown in figure 17, resulting in the sliding of the piston rod 8 and in the distribution of the first dose.
[0071] [0071] The distribution of the first dose occurs since the plunger stop 7d in the syringe 7 is propelled forward by the plunger rod 8 which, in turn, is slid by the actuation spring 10 and ends when the dose clamps 11 reach the second projection 27e of the guide channel 26a, 26b on the plunger sleeve 12 (figure 18). The separation spring 44 remains compressed between the transfer sleeve 23 and the plunger sleeve 12 during the delivery of the first dose.
[0072] [0072] Once the first dose is delivered, the user removes the device from the injection site after the determined waiting period. In this way, the automatic needle protection and drive mechanism are reconfigured. The return spring 35 is no longer affected by the forced contact between the front surface of the device and the injection site, and therefore pushes the sliding element 30 axially forward (figure 19), while the separation spring 44 decompresses to push the transfer sleeve 23 in the same direction by moving it away from the plunger rod 8 to reconfigure the drive mechanism. The locking pins 37 in the sliding element 30 interact with the descending part 36b of the cam 36 by the rotation of the cam sprocket 34. The sliding element 30 is prevented from turning due to the longitudinal ribs 32 engaged with the joints 31 in the outer body 1.
[0073] [0073] As the cam sprocket 34 rotates, it also travels the toothed extensions 15a of the dose selection collar 15. The dose selection collar 15 and dose selection button 4 do not rotate due to the resistance provided by the sprocket teeth on the plunger sleeve 12 and the corresponding sprocket teeth on the dose selection button 4. Once the return spring 35 returns the sliding element 30 to its fully extended position (figure 20), the locking pins locking 37 on the sliding element 30 and the locking face of the cam sprocket 34 prevent the sliding element 30 from being pressed (as the cam sprocket 34 is prevented from moving axially towards the rear of the device through the window 42).
[0074] [0074] Needle 7a is now prevented from being accessed as it is covered by the sliding element 30. The sliding element 30 cannot be pressed again until position 2 is selected by the user by rotating the dose selection button 4 Then, the user covers the device again.
[0075] [0075] If the distribution of a second dose is necessary, the user removes the cap 2 and turns the knob 4 from position 1 (first dose armed position) to position 2 (second dose armed position) to unlock the device.
[0076] [0076] With reference to figures 21 and 22, the rotation of the dose selection button 4 causes the rotation in the same direction of the integral selection sleeve 15 to it, thus aligning the second dose drive cam 23c on the sleeve transfer 23 and the second dose cam rail surface 15c on the selector sleeve 15, and the rotation of the cam sprocket 34 through the arms 15a with their toothed ends engaged within the sprocket ring 34a of the cam sprocket 34 to unlock the sliding element 30. Rotation of the cam sprocket 34 causes the relative sliding pins 37 of the sliding element 30 to slide on the bearing edge 36c of the cam sprocket 34 until the pins 37 are actuated at the entrance of the part ascending 36a of the cam rail 36 formed on the side surface of the cam sprocket 34. It is also noted that the dose selection knob 4 cannot be turned beyond position 2 due to the locking pins 37 whose sliding along the support edge 36c is limited by wall 36d.
[0077] [0077] To activate the device, the user presses the front surface of the sliding element 30 against the injection site, maintaining the device for its eternal body 1. The pressure of the sliding element 30 causes a resistance to force due to the contrast between the tines flexible 38 of the sliding element 30 and the end of the outer body 1. Thanks to their flexibility and the inclined contact surface, the flexible tines 38 result in pressure and deform internally to allow total axial depression of the sliding element 30 in the outer body 1 letting needle 7a protrude into the injection site. The movement subsequently created by the release of the vials quickly inserts needle 7a at the injection site.
[0078] [0078] The axial sliding of the sliding element 30 as a result of the pressure exerted by the user at the injection site causes the cam sprocket 34 to rotate axially, since the locking pins 37 slide against the rising part 36a of the cam rail 36. The sliding element 30 is prevented from turning due to the connection with the external body through the linear joint 31, 32. During this movement, the sprocket ring 34a of the cam sprocket 34 rotates in the permitted direction in view of the fact that the dose selection sleeve 15, engaged with the toothed ends of its arms 15a on the sprocket ring 34a, is prevented from turning since it is connected to the dose selection button 4 through the interface formed by the dose selection feet 16 of the button 4 engaged in the recesses 18 of the dose selection sleeve 15. The unidirectional rotation of the dose selection button 4 is achieved through the interface between the gear teeth 20 in the piston sleeve 12 and the teeth of corresponding gear wheel 19 on the dose selection button 4. The teeth on this interface are also designed to react to greater resistance to rotation than between the cam gear 34 and the selection sleeve 15. Therefore, the selection sleeve dose 15 remains stationary and the cam sprocket 34 travels through the toothed feet of the dose selection sleeve until the sliding element 30 reaches the final step of the axial sliding element.
[0079] [0079] Since the flexible tines 38 of the sliding element 30 deform sufficiently to allow the sliding element 30 to move axially into the outer body 1, the tubular protrusion 33 on the sliding element 30 comes into contact with the driving extensions 23a of the transfer sleeve 23. This, in turn, pushes the transfer sleeve 23 towards the rear of the device. During its axial movement (figures 23 and 24) the second dose drive cam 23c on the transfer sleeve 23 interacts with the second dose cam rail surface 15c on the selection sleeve 15, thus rotating the transfer sleeve 23 As the transfer sleeve 23 rotates, the dose pins 11 on the plunger rod 8 are shifted out of the second protrusion 27e of the guide channel 26a, 26b by the second linear length 29e of the cam channel 28a, 28b of the transfer 23. The diametrical alignment of the cam channel 28a, 28b and the guide channel 26a, 26b allow the dose pins 11 to fall from the second projection 27e to the third projection 27f and their axial sliding under the action of the actuation spring 10, this resulting in the sliding of the plunger rod 8 and the distribution of the second dose.
[0080] [0080] The distribution of the second dose occurs since the plunger stop 7d in the syringe 7 is propelled forward by the plunger rod 8 which, in turn, slides through the actuation spring 10 and ends when the dose clamps 11 reach the third protrusion 27f of the guide channel 26a, 26b in the plunger sleeve 12. The spring 44 remains compressed between the transfer sleeve 23 and the plunger sleeve 12 during the delivery of the second dose.
[0081] [0081] It is worth noting that a small volume of drug always remains in barrel 7c of syringe 7. In fact, the position of the third protrusion 27f of the guide channel 26a, 26b is designed in a way that when the radial preachers 11 reach the third projection 27f, the plunger stop 7d does not touch the bottom of the drum 7c. In this way, not only can the prescribed volume distribution of the drug be controlled, but also any manufacturing variation with respect to the internal length of the syringe barrel 7c can be mitigated with certainty. Therefore, dose accuracy is improved.
[0082] [0082] Once the second dose is delivered, the user removes the device from the injection site after the prescribed waiting period. The return spring 35 is not affected by the forced contact between the front surface of the device and the injection site and therefore pushes the sliding element 30 axially forward, while the spring 4 decompresses to push the transfer sleeve 23 in the same direction. moving it away from the plunger rod 8. The locking pins 37 on the sliding element 30 interact with the descending part 36b of the cam 36 by the rotation of the cam sprocket 34. The sliding element 30 is prevented from turning due to the longitudinal ribs 32 engaged with junctions 31 on the outer body 1.
[0083] [0083] As the cam sprocket 34 rotates it also travels the toothed extensions 15a of the dose selection collar 15. The dose selection collar 15 and the dose selection button 4 do not rotate due to the resistance provided by the sprocket teeth on the plunger sleeve 12 and the corresponding sprocket teeth on the dose selection button 4. Once the return spring 35 has returned the slide element 30 to its fully extended position, the locking pins 37 on the sliding element 30 and the locking face of the cam sprocket 34 prevents the sliding element 30 from being pressed (since the cam sprocket 34 is prevented from moving axially towards the rear of the device through the window 42).
[0084] [0084] The needle 7a is again prevented from being accessed due to being covered by the sliding element 30, which cannot be pressed further and the device is worn out. Then, the user covers the device again before disposing / handing it over to the paramedic.
[0085] [0085] Even if the self-injection device according to the invention described above is equipped with two dose clamps 11 to guide the movements of the piston rod 8, this solution being the preferred one to have a symmetrical distribution of the forces acting on the various components , it is clear that the solution in which only one dose preacher 11 is provided is constituted within the scope of the invention as an obvious variation. In that case, the stepped guide device 44 and the cam device for driving the device will be modified accordingly.
[0086] [0086] The autoinjector device according to the invention is suitable for dispensing drugs in solution, especially epinephrine (also known as adrenaline).
[0087] [0087] In particular, the doses of epinephrine that can be administered with the device of the invention are preferably in the range of 0.05 mg to 0.5 mg for each dose delivered (from 0.1 mg to 1 mg if two doses are considered).
[0088] [0088] Preferred doses for each distribution are 0.05 mg, 0.10 mg, 0.15 mg, 0.30 mg and 0.50 mg.
[0089] [0090] Said doses above are based on a concentration of the epinephrine solution preferably ranging from 0.05 mg / ml to 0.5 mg / ml, concentrations of 0.05 mg / ml, 0.1 mg / ml, 0.16 mg / ml, 0.3 mg / ml and 0.5 mg / ml are particularly preferred.

权利要求:
Claims (17)
[0001]
Automatic medication injection device, FEATURED by understanding: an external body (1) extending along a longitudinal geometric axis (X), a syringe unit (6) arranged in said external body (1) and fixed with the same, comprising a syringe (7) containing a medicine to injected, a needle (7a) and piston devices (8, 9) axially sliding, device for arming the device from a resting position to a first armed position to deliver a first dose and to a second armed position to deliver a second dose, said arming device being disposed at one end of said external body (1 ) and comprising a dose selection sleeve (15) extending within said external body (1); the first elastic device (10) disposed between said arming devices and said piston devices (8, 9), said first elastic devices being in a compressed state when the device is in its resting position and decompressing to push to facing said track device (8, 9) and distributing said first and second doses one after the other; an inner body (12) attached to said outer body (1) and coaxial with it, said piston device (8, 9) being slidably arranged therein; guiding device between said inner body (12) and said piston device (8, 9) for controlling the axial sliding movement of said piston device (8, 9) with respect to said inner body (12), said device guide comprising the first guide elements (26a, 26b) formed in said inner body (12) and the second guide elements (11) extending from said piston device (8, 9) and slidingly engaging within said first guide elements (26a, 26b), a sliding element (30) disposed on the other end of said external body (1) and prevented from sliding axially with it as a result of pressure exerted on its free end against the second elastic device (35) disposed between said sliding element (30) and said external body (1) between a first position, where the sliding movement of the sliding element (30) is prevented and the sliding element (30) extends from said external body (1) through the needle of the syringe (7a), and a second position, in which the sliding element (30) is retracted in said outer body (1) exposing the syringe needle (7a); cam transmission device between said sliding element (30) and said inner body (12) to transform the axial sliding of the sliding element (30) into a drive command for the device, comprising a sliding transfer sleeve (23) as a result of sliding the sliding element (30) and being formed with the first cam device of said transfer sleeve (23) to interact with said second guide elements (11) of said piston device (8, 9), said transfer sleeve (23) being axially articulated as a result of interaction of the second cam device of said transfer sleeve (23) with said internal body (12) and said selection sleeve (15), where said transfer sleeve transfer (23) is subjected to a first and a second angular displacement which, through said first cam device, displaces said second guide elements (11) pushing from them to the first driving condition dose and thereafter for the second dose triggering condition; third cam device being provided disposed within said outer body (1) and pivoted in only one direction as a result of axial sliding of said sliding element (30), said third cam device defining a cam rail (36) configured to controlling the movement of the sliding element (30) from the first position to said second position and back to said first position controlled by said second elastic device (35) since said pressure exerted on the free end of said sliding element (30) for.
[0002]
Device according to claim 1, CHARACTERIZED by the fact that said first guide elements comprise two guide channels (26a, 26b) extending longitudinally in diametrically opposite and symmetrical parts with axial rotation with respect to their shape, each channel being formed with a profiled edge with projections (27d, 27e) separated by linear lengths (27a, 27b, 27c) ending with a full support part (27f), said second guide elements comprising a pair of radial pins (11) extending on diametrically opposite sides and engaging in said guide channels (26a, 26b), in said first and second armed positions said preachers (11) leaning on said projections (27d, 27e).
[0003]
Device according to claim 2, CHARACTERIZED by the fact that said transfer sleeve (23) of said cam transmission device is coaxial with said internal body (12) and is slidably and articulated disposed in it and the said first cam device comprises two cam channels (28a, 28b) extending longitudinally in diametrically opposite parts and symmetrical with respect to axial rotation with respect to their shape, each of said channels being formed with a profiled edge with unevenness (28d, 29e), separated by linear lengths (29a, 29b, 29c) and ending with a full support part (29f), said stepped profile having a profile inverse to the stepped profile edge of said guide channels (26a, 26b) , said linear lengths (29a, 29b, 29c) leaning against said preachers (11) in said first and second armed positions to push them into said guide channels (26a, 26b) from said unevenness s (27d, 27e), causing the device to actuate to deliver the first dose, and after that, the second dose.
[0004]
Device according to any one of claims 1 to 3, CHARACTERIZED in that said second cam device comprises a pair of diametrically opposed first dose cams (23b) and a pair of diametrically opposed second dose cams (23c) to interact, in successive moments, with corresponding guide rails (12a) on said internal body (12) and, respectively, with corresponding guide rails (15c) on said selection sleeve (15).
[0005]
Device according to claim 4, CHARACTERIZED by the fact that in said selection sleeve (15) a first pair of diametrically opposed openings (150) is formed having two sides extending circumferentially, said second dose actuating cams (23c) engaging said openings (150), the first pair of openings (150) widening into a second pair of respective openings (151) of a substantially triangular shape, one side of which is aligned with one side of the opening (150 ) of said first pair, while the side opposite said opening (150) forms said guide rail (15c).
[0006]
Device according to any one of claims 1 to 5, CHARACTERIZED by the fact that said selection sleeve (15) of said arming device is integral with a selection button (4) that can be angularly displaced in only one direction around the said longitudinal geometric axis (X) with respect to said external body (1) and comprising a pair of extensions (15a) extending longitudinally in said external body (1) and engaging with a cam sprocket (34), in which the said third cam device (36) is formed to cause said third cam device to move angularly in the opposite direction to the angular displacement caused by them.
[0007]
Device according to claim 6, CHARACTERIZED in that said third cam device has a profile formed by an ascending part (36a), a descending part (36b) and a part (36c) extending along an arc circumference of the beginning of said rising part (36a) and the end of said falling part (36b), said rising part (36a) and said falling part (36b) being inclined in opposite directions, said sliding element (30) comprising at least one cam follower button (37) in contact with said profile, the sliding of said button (37) along said circumferential part (36c) being controlled by the angular displacement of said selection sleeve (15), the sliding along said upward part (36a) and downward part (36b) being controlled by the axial movement of said sliding element (30).
[0008]
Device according to claim 7, CHARACTERIZED in that said cam sprocket (34) is a tubular element with a lateral surface on which said third cam device (36) is formed, a toothed ring (34a) being formed on said cam sprocket (34) with which a corresponding toothed end of said extensions (15a) engages, the teeth of said toothed ring (34a) being profiled so as to allow said toothed end to slide along the said toothed ring (34a) in one direction only.
[0009]
Device according to any one of claims 1 to 8, CHARACTERIZED by the fact that a pair of extensions (23a) extend axially from said transfer sleeve (23) of said cam transmission device, the ends of said extensions (23c) supporting said sliding element (30), where the retroactive movement of the sliding element causes a corresponding sliding of said transfer sleeve (23) in opposition to the third elastic device (44) located between said transfer sleeve (23) and said internal body (12).
[0010]
Device according to any one of claims 1 to 9, CHARACTERIZED in that said internal body comprises a piston sleeve (12) having an end connected to an end of a barrel (7c) of the syringe (7) and supplied in the another end with a collar (3), a toothed ring (20) being formed in said collar (3) with which the corresponding toothed end of a pair of arms (19) engages, said arms (19) extending from of the selection button (4), the teeth of said toothed ring (20) being profiled so as to allow said toothed end to slide along said toothed ring (20) in only one direction.
[0011]
Device according to claim 10, CHARACTERIZED by the fact that the reference marks are provided on the external surface of said collar (3) and on said selection button (4) designed to be selectively aligned as a result of successive rotations of the selecting (4) from said resting position for said first armed position and said first armed position for said second armed position.
[0012]
Device according to claim 1, CHARACTERIZED by the fact that said piston device comprises a piston rod (8) slidably engaged in the barrel (7c) of the syringe (7) and a tubular housing (9) extending axially from said piston rod (8) and housing said first elastic device (10), said tubular housing being arranged in said selection button (4) around a projection (4a) thereof, said first device elastic comprising a spring (10) around said protrusion (4a), a bayonet-like connection (4c, 9a) being provided between said protrusion (4a) and said tubular housing (9) releasable as a result of the angular displacement of the said selection button (4) for said first armed position.
[0013]
Device according to claim 12, CHARACTERIZED by the fact that said bayonet connection is formed by the substantially T-shaped end (4c) of said protrusions (4a) and by two diametrically opposite internal projections (9a) of said housing ( 9), which are mutually engaged when the device is in the first resting position and detachable following an angular displacement of the selection button (4) in the direction of said first armed position.
[0014]
Device according to claims 12 or 13, CHARACTERIZED in that said second guiding device (11) extends outwardly from said tubular housing (9).
[0015]
Device according to any one of claims 1 to 14, CHARACTERIZED in that the flexible tines (38) protrude from the outer surface of the sliding element (30) to support against the end edge of said external body (1) , the contact area of said tines with said edge being tilted to allow sliding of said edge, where a moderate force exerted by the user is necessary to deform the tines (38) enough to allow the sliding element (30) to move axially inside the outer body (1).
[0016]
Device according to any one of claims 1 to 15, CHARACTERIZED in that said needle (7a) is covered by a guard and needle (7b) and a needle guard remover (45) is removably attached to the external body ( 1) and be provided with an internal tubular grip (45b) fitted to engage with the needle guard (7b), where, by pulling the needle guard remover (45) before the first dose is administered, the user can remove the needle cover (7b) and release the needle (7a) for injection.
[0017]
Device according to any one of claims 1 to 16, CHARACTERIZED by the fact that at least one opening (43) is formed in the outer body (1) aligned to at least one transparent inspection window (42) for checking the situation of drug distribution.

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法律状态:
2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

2019-10-29| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

2020-08-18| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

2020-09-24| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 06/09/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

申请号 | 申请日 | 专利标题

ITFI2011A000193|2011-09-08|

IT000193A|ITFI20110193A1|2011-09-08|2011-09-08|DEVICE FOR AUTOMATIC INJECTION OF TWO DRUG DOSES|

PCT/EP2012/067431|WO2013034647A1|2011-09-08|2012-09-06|Device for the automatic injection of two doses of a medicament|

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