![]() medicine injection pen
专利摘要:
PEN FOR DRUG INJECTION. It is a pen for injecting medication (11) that includes a housing (1) and a dose adjustment knob (2), which rotates in relation to the housing (1). An interruption assembly (68) is disposed within the housing (1) and has a ratchet member (43). An actuator (21) includes at least one outer tooth (57), which engages the ratchet member (43). The engagement between the ratchet member (43) and the at least one outer tooth (57) substantially prevents the actuator (21) from rotating with respect to the dose adjustment knob (2) during dose adjustment and dose correction . The engagement between the ratchet member (43) and the at least one outer tooth (57) allows the actuator (21) to rotate together with the dose adjustment knob (2) during an injection. 公开号:BR112014022666B1 申请号:R112014022666-0 申请日:2012-03-15 公开日:2021-05-04 发明作者:Michael Quinn;Richard Cronenberg 申请人:Becton, Dickinson And Company; IPC主号:
专利说明:
Field of Invention [001] In general terms, the present invention refers to a pen-type multipurpose injection device. More specifically, the present invention relates to a multi-purpose pen-type injection device with means for preventing rotation of a trigger when setting and correcting a dose. Fundamentals of the Invention [002] Various pen-shaped medication injection devices are known in the art. These prior art devices sometimes include features that allow the user to correct a dose that has been over-adjusted, which may be called a “reset”. Another feature offered by some of the prior art devices is the ability to control the last dose of a medicine cartridge so as to prevent the user from setting a dose greater than the amount of medicine remaining in the cartridge. This feature is sometimes called last dose control or last dose management. Both of these features are desired by users of these pen-shaped devices; however, prior art devices do not satisfy these needs satisfactorily. Many prior art devices offer one of these features, but not both. Furthermore, many of the prior art devices require additional steps to reset, which are inconvenient and not user-friendly. Therefore, there is a need in the art to provide, at the same time, better readjustment functionality and last dose control mechanisms in a pen for drug injection. [003] Prior art pen-shaped injection devices typically utilize drive components that are interference fit together to secure them in place, thus requiring tight manufacturing tolerances. In addition, many of the prior art pen-shaped injection devices utilize one-way ratchet systems that are difficult for the user to access for personalization. These ratchet systems typically require a substantial and complex manufacturing process to function. Therefore, there is a need for a pen-shaped injection device that eliminates interference fit components in order to provide a simple and easy-to-customize unit. Summary of Embodiments of the Invention [004] Exemplary embodiments of the present invention address at least the above problems and/or disadvantages and offer at least the advantages described below. [005] According to an exemplary embodiment of the present invention, a pen for injecting medication includes a housing and a dose adjustment knob, which rotates relative to the housing. An interruption assembly is disposed within the housing and has a ratchet member. An actuator includes at least one outer tooth, which engages the ratchet member. Engagement between the ratchet member and the at least one outer tooth substantially prevents the actuator from rotating with respect to the dose adjustment knob during dose adjustment and dose correction. On the other hand, the engagement between the ratchet member and the at least one outer tooth allows the trigger to rotate together with the dose adjustment knob during an injection. [006] According to another exemplary embodiment of the present invention, a pen for injecting medication includes a housing and a dose adjustment knob, which rotates relative to the housing. An interruption assembly is disposed within the housing and has a ratchet member. An interruption tower includes at least one outer tooth, which engages the ratchet member. A lead screw rotates with the rotation of the cut-off turret. A piston rod moves axially with the rotation of the lead screw to expel medication during an injection. Engagement between the ratchet member and the at least one outer tooth substantially prevents the lead screw from turning relative to the dose adjustment knob during dose adjustment and dose correction. On the other hand, the engagement between the ratchet member and the at least one outer tooth allows the lead screw to rotate together with the dose adjustment knob during an injection. [007] According to another exemplary embodiment of the present invention, a pen for injecting medication includes a housing and a dose adjustment knob, which rotates relative to the housing. An interruption assembly is disposed within the housing and has a ratchet member. An interruption tower includes at least one outer tooth, which engages the ratchet member. A lead screw rotates with the rotation of the cut-off turret. A piston rod moves axially with the rotation of the lead screw to expel medication during an injection. Engagement between the ratchet member and the at least one outer tooth substantially prevents the lead screw from turning relative to the dose adjustment knob during dose adjustment and dose correction. On the other hand, the engagement between the ratchet member and the at least one outer tooth allows the lead screw to rotate together with the dose adjustment knob during an injection. [008] Other objectives, advantages and notable characteristics of exemplary embodiments of the invention will become apparent to those skilled in the art by reading the following detailed description, which, together with the attached drawings, reveals exemplary embodiments of the invention. Brief Description of Drawings [009] The above characteristics and advantages as well as other characteristics and advantages of certain exemplary embodiments of the present invention will be apparent by reading the description of certain exemplary embodiments of the present invention when considered together with the accompanying drawings, among which: Fig. 1 illustrates a perspective view of an injection pen according to a first exemplary embodiment of the present invention; Fig. 2 illustrates an exploded perspective view of the injection pen of Fig. 1; Fig. 3 illustrates a cross-sectional plan view of the injection pen of Fig. 1 without a dose adjustment knob for clarity; Fig. 4 illustrates an enlarged, cross-sectional plan view of the injection pen of Fig. 3 with a dose adjustment knob; Fig. 5A illustrates a perspective view of a recoil member of the injection pen of Fig. 2; Fig. 5B illustrates a plan view of the distal end of the recoil member of Fig. 5A; Fig. 5C illustrates a cross-sectional plan view of the setback member of Fig. 5A; Fig. 6A illustrates a perspective view of an actuator of the injection pen of Fig. 2; Fig. 6B illustrates a plan view of the distal end of the actuator of Fig. 6A; Fig. 6C illustrates a plan and cross-sectional view of the actuator of Fig. 6A; Fig. 7A illustrates a perspective view of the dose adjustment knob of Fig. 2; Fig. 7B illustrates a cross-sectional plan view of the dose adjustment knob of Fig. 7A; Fig. 7C illustrates a plan view of the proximal end of the dose adjustment knob of Fig. 7A; Fig. 7D illustrates a plan view of the distal end of the dose adjustment knob of Fig. 7A; Fig. 8A illustrates a perspective view of an upper pen body of the injection pen of Fig. 2; Fig. 8B illustrates a cross-sectional plan view of the upper pen body of Fig. 8A; Fig. 8C illustrates a plan view of the distal end of the upper pen body of Fig. 8A; Fig. 9A illustrates a perspective view of a lead screw of the injection pen of Fig. 2; Fig. 9B illustrates a plan view of the distal end of the lead screw of Fig. 9A; Fig. 10 illustrates an exploded view of the assembly of an interruption assembly for the injection pen of Fig. 2; Fig. 11A illustrates a perspective view of the interrupt assembly of Fig. 10; Fig. 11B illustrates a plan view of the distal end of the interruption assembly of Fig. 11A; Fig. 11C illustrates a plan view of the proximal end of the interruption assembly of Fig. 11A; Fig. 12 illustrates a plan and cross-sectional view of the interrupt assembly of Fig. 10; Fig. 13 illustrates an exploded perspective view of an injection pen according to a second exemplary embodiment of the present invention; Fig. 14 illustrates a cross-sectional plan view of the injection pen of Fig. 13 without a dose adjustment knob for clarity; Fig. 15 illustrates a plan and cross-sectional view of the injection pen Fig. 13; Fig. 16A illustrates a perspective view of a lead screw of the injection pen of Fig. 12; Fig. 16B illustrates a cross-sectional plan view of the lead screw of Fig. 16A; Fig. 16C illustrates a plan view of the distal end of the lead screw of Fig. 16A; Fig. 17A illustrates a perspective view of an interruption tower of the injection pen of Fig. 12; Fig. 17B illustrates a plan view of the distal end of the switchgear of Fig. 17A; Fig. 17C illustrates a plan and cross-sectional view of the interruption tower of Fig. 17A; Fig. 18A illustrates a perspective view of a piston rod of the injection pen of Fig. 12; Fig. 18B illustrates a cross-sectional plan view of the piston rod of Fig. 18A; Fig. 18C illustrates a plan view of the proximal end of the piston rod of Fig. 18A; Fig. 19A illustrates a perspective view of the distal end of an interruption member of the injection pen of Fig. 12; Fig. 19B illustrates a perspective view of the proximal end of the interruption member of Fig. 19A; 1. Fig. 19C illustrates a plan view of the proximal end of the interruption member of Fig. 19A; Fig. 19D illustrates a plan view of the distal end of the interruption member of Fig. 19A; and Fig. 19E illustrates a side plan view of the interruption member of Fig. 19A. [010] Throughout the drawings, like reference numbers refer to like elements, dashes, and structures. Detailed Description of Exemplary Achievements [011] The topics exemplified in this description are given in order to help comprehensively understand exemplary embodiments of the invention with reference to the figures in the accompanying drawings. Therefore, those skilled in the art will appreciate that it is possible to make various changes and modifications to the exemplary embodiments described herein without thereby departing from the scope or essence of the claimed invention. Furthermore, descriptions of well-known functions and structures may be omitted for clarity and brevity. [012] Fig. 1 illustrates a perspective view of an injection pen 11 according to an exemplary embodiment of the present invention. As illustrated, the injection pen 11 includes an upper pen housing or body 1 which houses various injection and dose adjustment components. The upper pen body 1 connects to a cartridge housing 17, which houses a medication cartridge 18, as shown in Figs. 1 and 3. Injection pen 11 may also include a lower pen cap (not shown) to protect cartridge 18 and cartridge housing 17 when injection pen 11 is not in use. As illustrated, the injection pen 11 includes a dose adjustment knob 2, which includes a knob-like portion 4 that the user rotates to set a desired dose. The dose adjustment knob 2 also includes a number of numerals, as shown in Fig. 2, which correspond to the number of dosage units visible through a window 13 formed in the upper body 1, as shown in Fig. 8A. The user rotates the dose adjustment knob 2 until the desired dose is displayed in Window 13. The upper pen body 1 may include an arrow or other indicator 14 to accurately point out the adjusted dose. After setting the desired dose, the user presses a pressure button 3 until the set dose amount is fully injected. [013] The pushbutton 3 is at the proximal end, closest to the user and farthest from the needle (not shown), of the upper pen body 1, as shown in Fig. 4. Preferably, the pushbutton 3 comprises an annular rim or edge 5 which engages with a corresponding annular groove 6 formed on the inner surface of the button-like portion 4 of the dose adjustment knob 2. Preferably, the annular rim/groove connection is a friction fit that holds the knob. of push-button 3 in a polarized position over dose adjustment knob 2 by the action of a button spring 10, but allows push-button 3 to be pressed towards dose adjustment knob 2 to inject an adjusted dose. As shown in Fig. 4, the groove 6 in the button-like portion 4 of the dose adjustment knob 2 extends axially to allow the push button 3 to be pressed towards the dose adjustment knob 2 during an injection. The interior of push-button 3 accommodates a setback bearing insert 8 which rests on the inner surface at the proximal end of setback member 9. As shown in Fig. 4, bearing insert 8 has an annular collar 12 received in a groove ring 13 (Fig. 5C) adjacent to the proximal end 16 of the recoil member 9. The push button 3 is designed to rotate freely on the recoil bearing insert 8. [014] The recoil member 9 is a cylindrical member, as illustrated in Figs. 2 and 5A to 5C, coaxial with and surrounded by dose adjustment knob 2. The recoil member 9 is coaxially disposed around a driver 21 as shown in Figs. 3 and 4, which is rotatably secured to the recoil member 9 and moves axially relative to the recoil member 9. The driver 21 coaxially surrounds a lead screw 23, as shown in Figs. 3 and 4. The recoil member 9 includes a set of protrusions 24, which extend inwardly from the inner surface 25 at the distal end 26 and engage with axially extending slots 27 at the outer surface 28 of the actuator 21 in order to rotatably lock the actuator 21 to the recoil member 9. The actuator 21 has threads 29 on part of its inner surface 30 at the distal end of the actuator 21, as shown in Fig. 6C. The driver 21 coaxially surrounds a lead screw 23, which includes a plurality of thread segments 31 disposed substantially along the entire axial extent of the lead screw 23, as shown in Figs. 2, 9A and 9B. The various thread segments 31 are formed in opposition to flattened portions 32 formed between them. A flange 33 is disposed at the distal end of lead screw 23 to engage a stop 34 on cartridge 18. Internal threads of driver 29 threadedly engage external threads 31 formed on lead screw 23. As described in more detail below, thanks to its threaded engagement with driver 21, lead screw 23 penetrates cartridge 18 during injection so as to press a stop 34 into cartridge 18 in order to expel a dose of medication. A corrugated clip 35, as shown in Figs. 2 and 3, is disposed between the distal end of an interruption member 36 and the proximal end of the cartridge 18 to force the cartridge 18 distally in order to substantially prevent its displacement during injection and thus ensure injection of an accurate dose. [015] The interrupt member 36 is disposed within the upper pen body 1, as illustrated in FIGs. 3 and 4. Interrupt member 36 is a substantially cylindrical member with a substantially flat base 37, of which a wall 38 extends axially outwardly. An opening 39 in base 37 receives lead screw 23. An elastic member 41 is disposed on the inner surface 42 of the base of stop member 36. A ratchet disc 43 is disposed on elastic member 41. Preferably, the disc ratchet 43 is circular, with an opening 44 formed therein to receive lead screw 23. A pair of protrusions 45 extend outwardly from ratchet disc 43 to engage slots 40 in stop member 36. 40 substantially prevent the rotation of the ratchet disc 43 and at the same time allow its axial movement. A plurality of teeth 46 extend upwardly from the upper surface 47 of the ratchet disk 43. Each tooth 46 has an inclined surface 48, which forms an obtuse angle along the upper surface 47, and an abutment surface 49, disposed substantially perpendicular to the upper surface 47. [016] To adjust a dose using the pen-shaped injection device of the first exemplary embodiment, the user rotates the knob-like part 4 of the dose adjustment knob 2 with respect to the upper pen body 1. The outer surface of the knob dose setting 2 includes a thread 50, as best illustrated in Figs. 2 and 7A, which threadly engages a plurality of threads 51 formed on the inner surface 52 of the upper pen body 1 as illustrated in Figs. 2 and 8C. Therefore, as dose adjustment knob 2 rotates relative to upper pen body 1, dose adjustment knob 2 screws or advances some distance away from upper pen body 1. Dose adjustment knob 2 includes a shoulder or annular rim 52 on its inner surface near the proximal end, as illustrated in Figs. 7A and 7B. The annular shoulder 52 engages an enlarged portion or tip 53 of the recoil member 9, as shown in Figs. 2, 5A and 5C. Preferably, the annular shoulder 52 of the dose adjustment knob 2 comprises a plurality of teeth or recesses 54 which engage with a plurality of teeth or recesses of the same shape 55 formed in the flared tip 53 of the recoil member 9. During dose adjustment, the dose adjustment knob 2 is free to rotate relative to recoil member 9 either clockwise or counterclockwise. When this happens, the various teeth or recesses 54 of the dose adjustment knob 2 slip over the teeth 55 formed on the flared tip 53 of the recoil member, thus causing a tactile indication or clicking sound that indicates the adjustment of a dosage unit. . As described in more detail below, the dose adjustment knob 2 is able to rotate relative to the setback member 9 during adjustment thanks to a unidirectional ratchet which prevents the setback member 9 from rotating together with the dose setting knob 2 in the adjustment direction. [017] The rotation of the dose adjustment knob 2 in the dose adjustment direction is not transferred to the recoil member 9 thanks to the unidirectional ratchet between the driver 21 and the ratchet disc 43, as shown in Fig. 3. Close to at its distal end, the recoil member 9 includes a pair of protrusions 24, as illustrated in Figs. 2 and 5C. The pair of protrusions 24 engages a pair of slots 27 in the driver 21 as shown in Figs. 2 and 6A. The protrusions 24 and slots 27 rotatably lock the recoil member 9 and the driver 21 together and at the same time allow axial movement of the recoil member 9. A flange 56 disposed at the distal end of the driver 21 has a number of teeth 57 formed on its lower surface. Actuator teeth 57 have sloped surfaces 58 and stop surfaces 59 as shown in Fig. 6A. Stop surfaces 59 of drive teeth 57 engage with stop surfaces 49 of ratchet disk teeth 46, thus preventing rotation of driver 21. Elastic member 41 forces ratchet disk 43 to engage with the flange of the ratchet actuator to help prevent the rotation of the actuator 21. Therefore, by preventing the actuator 21 from rotating, the recoil member 9 is also prevented from rotating. As dose adjustment knob 2 is rotated away from upper pen body 1 during dose adjustment, engagement between flared tip 53 of recoil member 9 and shoulder 52 of dose adjustment knob 2 makes causing the recoil member 9 to move axially as the protrusions 24 run into the slots of the actuator 27. As mentioned above, the teeth of the dose adjustment knob 54 slip over the teeth of the recoil member 55 during adjustment. to emit a clicking sound to indicate to the user that a dose has been adjusted. [018] In order to correct a dose set too high, the user turns the dose setting knob 2 back in the opposite direction. Rotation of the dose adjustment knob 2 in this direction is not transferred to the recoil member 9 thanks to the unidirectional ratchet between the actuator 21 (to which the recoil member 9 is rotatably fixed) and the ratchet disc 43, as shown in Fig. 3. Friction between teeth 54 and 55 of dose adjustment knob 2 and recoil member 9 is not great enough to overcome friction between actuator flange 56 and spring-loaded ratchet disc 43. Accordingly, it is possible to turn the dose adjustment knob 2 back to correct an adjusted dose without causing the recoil member 9 to rotate in that direction, although the recoil member 9 moves axially thanks to the engagement of the recoil member protrusions 24 with the slots of the actuator 27. Hence, the teeth of the dose adjustment knob 54 slip over the teeth of the recoil member 55, which is prevented from rotating, so as to emit a clicking sound during dose resetting, thus as with normal dose adjustment. [019] As the dose adjustment knob 2 screws or advances axially away from the upper body 1 during the adjustment of a dose, the recoil member 9 is also forced to move axially away from the body by a corresponding distance . This axial movement is caused thanks to the engagement with the annular shoulder 52 on the dose adjustment knob 2, which urges the widened tip 53 of the recoil member 9 during its movement away from the upper pen body 1. After setting a desired dose , the user presses the push button 3 coupled to the recoil bearing insert 8, which connects axially to the recoil member 9. With the force exerted by the user depressing the push button 3, the recoil member 9 assumes an engagement of locking or meshing with the dose adjustment knob 2 on account of the gearing between the respective teeth or recesses 55 and 54 formed in the recoil member 9 and the dose adjustment knob 2, respectively. As the user continues to depress push-button 3, dose adjustment knob 2 rotates and screws back down the upper pen body 1 thanks to the threaded engagement between thread 50 on dose adjustment knob 2 and the thread 51 on the upper pen body 1. The rotation of the dose adjustment knob 2 is then transferred to the recoil member 9 thanks to its locking engagement or gear. The force of the user depressing the button 3 is sufficient to overcome friction between the disc ratchet 43 and the actuator flange 56, and therefore the recoil member 9 rotates in that direction. [020] Rotation of recoil member 9, as allowed during injection, is then transferred to driver 21, which is rotatably secured to recoil member 9 by a groove-protrusion connection between driver 21 and recoil member 9. As illustrated in Figs. 5B and 5C, the inner surface 25 of the recoil member 9 has inwardly extending protuberances 24 which engage with axially extending slots 27 in the driver 21, as illustrated in Fig. 3. Preferably, the back member setback 9 includes two opposing protrusions 24 for engaging two opposing slots 27 in driver 21. Retract member 9 moves axially relative to driver 21 during dose adjustment and dose correction, thanks to the interconnection between the protrusions 24 and slits 27 as illustrated in Fig. 3. The length of slit 27 in trigger 21 can be configured to match a maximum allowable dose to be injected in a single injection. The driver 21 is axially fixed with respect to the upper pen body 1 thanks to a transverse wall 60. The upper surface 61 of the flange 56 abuts the transverse wall 60 of the upper pen body 1. The elastic member 41 forces the flange of the actuator 56 making contact with the transverse wall 60 through the ratchet disc 43. [021] When the recoil member 9 rotates together with the dose adjustment knob 2 during injection, the driver 21 rotates together with the recoil member 9. The slanted surfaces 58 and 46 of the actuator teeth 57 and the teeth of the ratchet disc 46 engage such that driver 21 rotates relative to ratchet disc 43. Elastic member 41 forces ratchet disc 43 into contact with driver flange 56, thus causing a tactile signal and/ or a clicking sound as drive teeth 57 slip over ratchet disk teeth 46. Outwardly extending protrusions 45 on ratchet disk 43 are received in the slots of stop member 40, thus preventing rotation of the disk turnstile 43. [022] As described above, lead screw 23 includes several thread segments 31 that threadedly engage threads 29 in partially threaded driver 21, as shown in Fig. 3. Preferably, only a few thread segments are formed at the end. of the actuator 21, as shown in Fig. 6C. The lead screw 4 is held non-rotatably with respect to the upper pen body 1 by the opening 39 in the stop member 36. The opening 39 has a shape corresponding to the shape of the lead screw 4, which has flattened sides such as so that the lead screw 4 is prevented from rotating with respect to the interruption member 36. The interruption member 36 is prevented from rotating with respect to the upper pen body 1 thanks to the engagement between the slots 40 in the interruption member 36 and protrusions 62 extending axially and distally from the transverse wall 43 as illustrated in Figs. 3, 8B and 8C. Rotation of the axially fixed driver 21 rotates lead screw 23 thanks to the threaded engagement between them, thus driving lead screw 23 distally towards cartridge 18. Axial movement of lead screw 23 pushes stop 34 distally towards the cartridge 18 in order to expel the medicine stored in it. [023] During assembly, the driver 21 is inserted into the upper pen body 1 from the distal end. Stop assembly 68 includes stop member 36, elastic member 41, and ratchet disc 43, as illustrated in FIGs. 10-12. Interrupt assembly 68 is inserted into upper pen body 1 from the distal end. Lead screw 23 is inserted through opening 39 in stop member 36 and through opening 69 in driver 21. Thereafter, driver 21 is rotated to pull lead screw 23 proximally. Slots 40 in interrupt member 36 rotatably secure interrupt member 36 to upper pen body 1. Flattened sides 62 at the opening of interrupt member 39 receive flattened portions 32 of lead screw threads 31 to prevent rotation. lead screw 23 and restrict the lead screw to axial movement. [024] As lead screw 23 does not rotate relative to body 1, as drive 21 rotates during injection, as described above, thanks to its rotary coupling with recoil member 9, lead screw 23, thanks to its threaded engagement with the actuator 21, it is forced to move in the distal direction so as to press the stop 34 disposed on the medicine cartridge 18, thus expelling a liquid medicine therefrom. Lead screw 23 is prevented from moving in the proximal direction because driver 21 only rotates in one direction (which results in distal movement of lead screw 23) due to the unidirectional ratchet between driver 21 and the ratchet disc 43 of the interruption member 36. Thus, an accurate dosing is ensured because the lead screw 23 maintains its engagement with the stop 34 between one injection and another. Preferably, there is a mechanical advantage such that the dose adjustment knob 2 moves further in the axial direction than the lead screw 23 during injection, thus decreasing the injection force that the user must exert. This is preferably accomplished by providing different steps for the threaded connection between the dose adjustment knob 2 and the upper pen body 1 and the threaded connection between the actuator 21 and the lead screw 23. The ratio of the thread pitch may vary depending on the liquid drug and expected dose volumes. For example, the step ratio can be 4.35:1 or 3.25:1, but it is not limited thereto. [025] A dose interruption member 71 (Figs. 2 and 4) can be included for the management of the last dose, in order to prevent adjustment of a dose greater than the remaining amount of medication in cartridge 18. dose stop 71 is axially sliding yet rotatably fixed relative to recoil member 9 by being positioned between a pair of prominences 63 formed on outer surface 64 of recoil member 9, as illustrated in FIGs. 2, 5A and 5B. Preferably, the dose interrupt member 71 is a half-nut-like element that is threaded onto its outer surface with a plurality of threads 72. The threads of the dose interrupt member 72 are configured to engage with corresponding threads 65 formed on the surface. internal 66 of the dose adjustment knob 2, as shown in Figs. from 7A to 7C. At first, the dose stopping member 71 threadsly engages one or two of the most proximal threads among the threads 65 formed on the dose adjustment knob 2. During dose adjustment, as the dose adjustment knob 2 rotates with respect to the recoil member 9 and therefore also with respect to the dose stopping member 71, the dose stopping member 71 is forced to move distally by a distance corresponding to the set dose, thanks to its engagement with threads 65 on dose adjustment knob 2. [026] During injection, as the recoil member 9 and the dose adjustment knob 2 are rotatably coupled as discussed above, the dose interrupt member 71 maintains its position with respect to the threads 65 of the dose adjustment knob 2 The dose stopping member 71 moves distally during dose adjustment until the distal edge 72 (Fig. 4) of the dose stopping member 71 abuts an inwardly facing protrusion 67 formed on the inner surface 66 of the dose adjustment knob 2, as shown in Figs. 7B and 7D. In this position, the dose stopping member 72 is prevented from moving further distally, which also prevents further rotation of the dose adjustment knob 2 to set a larger dose. In its final position, the dose stop member 71 threadedly engages about two of the most distal threads among the threads 65 formed on the dose adjustment knob 2. As illustrated in Fig. 7B, the total distance traveled by the dose interrupt member 71 from the start position to the end position, when it abuts the protrusion 67 formed in the dose adjustment knob 2, is greater than the length of any of the threaded portions formed in the dose interrupt member 71 and on dose adjustment knob 2, respectively. [027] Figs. 13-19D illustrate a second exemplary embodiment of an injection pen with functionality similar to the first exemplary embodiment. Like reference numbers were used when the illustrated components were substantially the same, and their descriptions will not be repeated for the sake of brevity. [028] The recoil member 9 is a cylindrical member, as shown in Fig. 13, coaxial to the dose adjustment knob 2 and surrounded by it. The recoil member 9 is coaxially arranged around an interruption turret 121 as shown in Figs. 13 and 14, which is rotatably secured to the recoil member 9. The recoil member 9 moves axially relative to the cutoff tower 121. The cutoff tower 121 coaxially surrounds a lead screw 123, as shown in Figs. 13 and 14. The recoil member 9 includes a set of protrusions 24, which extend inwardly from the inner surface 25 at the distal end 26 and engage with axially extending slots 127 at the outer surface 128 of the interruption tower 21 in order to rotatably lock the cut-off tower 121 to the recoil member 9. The cut-off tower 121 coaxially surrounds a piston rod 161, which is disposed between the cut-off tower 121 and the lead screw 123. The lead screw 123 it is partially threaded and has a number of thread segments 161 disposed along part of its axial extension at the distal end 134 of lead screw 123, as illustrated in Figs. 16A and 16B. The various thread segments 131 are formed in opposition to flattened portions 132 formed between them. A flange 133 is disposed at the distal end of the actuator 133 to engage the shutoff tower 121 as shown in Figs. 14 and from 16A to 16C. The piston rod has internal threads 162, which preferably extend axially along its entire internal surface, as illustrated in Figs. from 18A to 18C. The internal threads 162 of the piston rod 161 threadedly engage with the external threads 131 formed in the lead screw 123. As described in more detail below, thanks to its threaded engagement with the cutout tower 121, the lead screw 123 penetrates into the cartridge 18 (Fig. 2) during injection so as to depress a stop 34 (Fig. 2) disposed within cartridge 18 in order to expel a dose of medication. A corrugated clip 35, as shown in Figs. 13 to 15, is disposed between the distal end of an interruption member 136 and the proximal end of the cartridge 18 to force the cartridge 18 in the distal direction in order to substantially prevent its displacement during injection and thus ensure injection. of an accurate dose. [029] The interrupt member 136 is disposed within the upper pen body 1, as illustrated in FIGs. 14 and 15. Interrupt member 136 is a substantially cylindrical member with a substantially flat base 137, of which a wall 138 extends axially outwardly, as illustrated in Figs. 19A to 19E. An opening 139 in base 37 receives piston rod 161. A pair of substantially circumferentially extending flexible arms 141 connect to wall 138 of interruption member 136. Hooks 143 extend radially inward from ends free of the flexible arms 141. Each hook 143 has an inclined surface 148, which forms an obtuse angle with the flexible arm 141, and a stop surface 149, disposed substantially perpendicular to the flexible arm 141. Slits 144 are formed in the opening for receiving protrusions 163 extending radially along the outer surface 164 of the piston rod 161 (Fig. 18A). Slots 140 are formed in wall 138 of interruption member 136 to receive axial protrusions 62 (Fig. 8B) of upper pen body 1 to substantially prevent rotation of interruption member 136 relative to upper pen body 1. Hooks 143 of flexible arms 141 engage teeth extending radially from interruption tower 121 to form a unidirectional ratchet system therebetween. [030] To adjust a dose using the pen-shaped injection device of the second exemplary embodiment, the user rotates the knob-like part 4 of the dose adjustment knob 2 with respect to the upper pen body 1. The outer surface of the knob dose setting 2 includes a thread 50, as best illustrated in Figs. 13 and 7A, which threadly engages a plurality of threads 51 formed on the inner surface 52 of the upper pen body 1 as shown in Figs. 2, 8C and 13. Therefore, as dose adjustment knob 2 rotates relative to upper pen body 1, dose adjustment knob 2 screws or advances some distance away from upper pen body 1. The annular shoulder 52 of the dose adjustment knob 2 engages the flared tip 53 of the recoil member 9, as shown in Fig. 15. Preferably, the annular shoulder 52 of the dose adjustment knob 2 comprises a plurality of teeth or recesses 54 which engage a plurality of teeth or similarly shaped recesses 55 formed in the flared tip 53 of the recoil member 9. During dose adjustment, the dose adjustment knob 2 is free to rotate relative to the recoil member 9 in either direction. clockwise or counterclockwise. When this happens, the various teeth or recesses 54 of the dose adjustment knob 2 slip over the teeth 55 formed on the flared tip 53 of the recoil member, thus causing a tactile indication or clicking sound that indicates the adjustment of a dosage unit. . As described in more detail below, the dose adjustment knob 2 is able to rotate relative to the setback member 9 during adjustment thanks to a unidirectional ratchet which prevents the setback member 9 from rotating together with the dose setting knob 2 in the adjustment direction. [031] The rotation of the dose adjustment knob 2 in the dose adjustment direction is not transferred to the recoil member 9 thanks to the unidirectional ratchet between the interruption tower 121 and the interruption member 136, as illustrated in Figs. 14 and 15. Protrusions of recoil member 24 engage slots 127 in cut-off tower 121. Protrusions 24 and slots 127 rotatably lock recoil member 9 and cut-off tower 121 together. A flange 156 disposed at the distal end of the interruption tower 121 has a number of teeth 157 extending radially outwardly therefrom. The teeth of the interruption tower 157 have an inclined surface 158 and a stop surface 159, as shown in Fig. 17B. The stop surfaces 159 of the cutout tower teeth 157 engage the stop surfaces 149 of the cutout member hooks 143, thus preventing the cutout tower 121 from rotating. Therefore, by preventing the cutout tower 121 from rotating, recoil member 9 is prevented from rotating. As dose adjustment knob 2 is rotated away from upper pen body 1 during dose adjustment, engagement between flared tip 53 of recoil member 9 and shoulder 52 of dose adjustment knob 2 makes causing the recoil member 9 to move axially as the protrusions 24 run into the slots of the shutoff tower 127. The teeth of the dose adjustment knob 54 slip over the teeth of the recoil member 55 during dose adjustment so as to emit a clicking sound to indicate to the user that a dose has been adjusted. [032] In order to correct a dose set too high, the user turns the dose setting knob 2 back in the opposite direction. Rotation of the dose adjustment knob 2 in this direction is not transferred to the recoil member 9 thanks to the unidirectional ratchet between the stop tower 121 (to which the recoil member 9 is rotatably fixed) and the stop member 136, as illustrated to Figs. 14 and 15. The friction between teeth 54 and 55 of dose adjustment knob 2 and recoil member 9 is not great enough to overcome the friction between teeth of stop tower 157 and hooks of stop member 141 In this way, it is possible to turn the dose adjustment knob 2 back to correct an adjusted dose without causing the recoil member 9 to rotate in that direction, although the recoil member 9 moves axially thanks to the engagement of the limb protrusions of recoil 24 with the cutout tower slots 127. Thus, the teeth of the dose adjustment knob 54 slip over the teeth of the recoil member 55, which is prevented from rotating, so as to emit a clicking sound during resetting. dose as well as with normal dose adjustment. [033] As the dose adjustment knob 2 screws or advances axially away from the upper body 1 during the adjustment of a dose, the recoil member 9 is also forced to move axially away from the body by a corresponding distance . This axial movement is caused thanks to the engagement with the annular shoulder 52 on the dose adjustment knob 2, which urges the widened tip 53 of the recoil member 9 during its movement away from the upper pen body 1. After setting a desired dose , the user presses pushbutton 3 coupled to recoil bearing insert 8, which axially connects to recoil member 9. An elastic member 10 can be disposed between pushbutton 3 and bearing insert 8, as illustrated. Fig. 2. With the force exerted by the user pressing the push button 3, the recoil member 9 takes on a locking or gear engagement with the dose adjustment knob 2 on account of the gear between the respective teeth or recesses 55 and 54 formed in the recoil member 9 and the dose adjustment knob 2, respectively. As the user continues to depress push-button 3, dose adjustment knob 2 rotates and retreats distally towards upper pen body 1 thanks to the threaded engagement between thread 50 on dose adjustment knob 2 and the thread 51 on the upper pen body 1. The rotation of the dose adjustment knob 2 is then transferred to the recoil member 9 thanks to its locking engagement or gear. The force of the user depressing the button 3 is sufficient to overcome friction between the hooks of the interruption member 143 and the teeth of the interruption tower 157, and therefore the recoil member 9 rotates in that direction. [034] The rotation of the recoil member 9, as allowed during injection, is then transferred to the cut-off tower 121, which is rotatably fixed on the recoil member 9 by a groove-protrusion connection between the cut-off tower 121 and the member setback 9. As illustrated in Figs. 5B and 5C, the inner surface 25 of the recoil member 9 has inwardly extending protrusions 24 which engage with axially extending slots 127 in the interruption tower 121, as shown in Fig. 15. recoil member 9 includes two opposing protrusions 24 for engaging two opposing slots 127 in cut-off tower 121. recoil member 9 moves axially with respect to cut-off tower 121 during dose adjustment and dose correction, thanks to the interconnection between protrusions 24 and slits 127, as illustrated in Fig. 15. The length of slit 27 in interruption tower 121 can be configured to correspond to a maximum dose to be injected in a single injection. The interruption tower 121 is axially fixed with respect to the upper pen body 1 thanks to a transverse wall 60. The upper surface 118 of the flange 156 of the interruption tower 121 abuts the transverse wall 60 of the upper pen body 1, as shown in Figs. 14 and 15, to prevent axial movement of the interruption tower 121 in the proximal direction. Cartridge 18 and cartridge housing 17 threadedly connected to upper pen body 1 prevent axial movement of stop tower 121 in the distal direction. [035] When the recoil member 9 rotates together with the dose adjustment knob 2 during injection, the cut-off tower 121 rotates with the recoil member 9. The angled surfaces 158 and 148 of the cut-off tower teeth 157 and the hooks of the stop member 143 engage and cause the stop tower 121 to rotate relative to the stop member 136. A tactile signal and/or clicking sound indicating dose delivery occurs as the teeth of the interruption tower 157 slides over the interruption member hooks 143. The slots 140 of the interruption member 136 receive the protrusions 62 of the upper pen body 1, thus preventing the rotation of the interruption member 136. [036] As described above, lead screw 123 includes a number of thread segments 131 that threadedly engage threads 162 on piston rod 161, as illustrated in Figs. 14 and 15. Preferably, only a few thread segments are formed at the distal end of lead screw 123, as illustrated in Figs. 16A and 16B. Piston rod 161 is non-rotatably retained with respect to upper pen body 1 because axially extending protrusions 163 are received in slots 144 in opening 139 of interruption member 136. Protrusions 163 are received in slots 144 for preventing the rotation of the piston rod 161 within the stop member 136, which is prevented from rotating within the upper pen body 1 because the slots of the stop member 140 receive the protrusions 72 of the upper pen body 1. The rotation of the turret stop screw 121 axially fixed turns lead screw 123 axially fixed thanks to the keyed connection between them. An axially extending protrusion 171 extends from the upper surface 172 of flange 133 on lead screw 123, as shown in Fig. 16A. An opening 174 is formed in an inwardly extending flange 175 at the proximal end of the interruption tower 121, as illustrated in Figs. 17B and 17C. The shape of the opening of the stop tower 174 corresponds to the protrusion of the lead screw 171, as shown in Figs. 16A and 17C. The upper surface 172 of the lead screw 133 flange prevents proximal movement of the lead screw 123. Rotation of the cut-off tower 121 rotates the lead screw 123 thanks to the keyed connection between the lead screw bulge 171 and the opening of the lead screw. shutoff turret 174. Threaded engagement between lead screw threads 131 and internal threads 162 of piston rod 161 drives piston rod 161 distally into cartridge 18. Axial movement of piston rod 161 pushes stopper 34 distally towards the cartridge 18 in order to expel the drug stored in it. [037] As the piston rod 161 does not rotate relative to the upper pen body 1, as the lead screw 123 rotates during injection, as described above, thanks to its rotational coupling with the interruption tower 121, which is rotatably coupled to the recoil member 9, the piston rod 161, thanks to its threaded engagement with the lead screw 123, is forced to move distally so as to press the stop 34 disposed on the medicine cartridge 18, expelling thus a liquid medicine from this. Piston rod 161 is prevented from moving in the proximal direction because lead screw 123 only rotates in one direction (resulting in distal movement of piston rod 161) by virtue of the unidirectional ratchet between stop member 136 and the stop tower 121. This ensures an accurate dosing because the piston rod 161 maintains its engagement with the stop 34 between one injection and another. [038] Although the present invention has been illustrated and described with reference to specific illustrative embodiments, it is not limited to these exemplary embodiments, but only the appended claims and their equivalents. It will be appreciated that those skilled in the art can change or modify the exemplary embodiments without thereby departing from the scope or essence of the present invention.
权利要求:
Claims (12) [0001] 1. A pen for injecting medicine comprising: a housing (1); a dose adjustment knob (2) which rotates with respect to said housing (1); an interruption assembly (36) which is disposed within said housing (1) and has a ratchet member (43); and an actuator (21) CHARACTERIZED in that said actuator (21) includes at least one outer tooth (57) that engages with said ratchet member (43) wherein said at least one outer tooth (57) extends axially and said ratchet member (43) extends axially; wherein during dose adjustment and dose correction, stop surfaces (59) of said at least one outer tooth (57) of said driver (21) engage stop surfaces (49) of member tooth (46) of ratchet (43) to prevent said actuator (21) from rotating with respect to said dose adjustment knob (2), and during an injection, said actuator (21) moves in locking engagement with said dose knob (2). dose adjustment (2), thus overcoming friction between said ratchet member (43) and said actuator (21) to allow said actuator (21) to rotate with said dose adjustment knob (2). [0002] 2. Medicine injection pen according to claim 1, CHARACTERIZED by the fact that an elastic member (41) forces said ratchet member (43) into said engagement with said at least one outer tooth (57 ). [0003] 3. Medicine injection pen, according to claim 1, CHARACTERIZED by the fact that said actuator (21) is axially fixed during said dose adjustment and said dose injection. [0004] The medicine injection pen according to claim 1, CHARACTERIZED by further comprising: a lead screw (23) axially movable with the rotation of said actuator (21) in order to expel medicine during an injection. [0005] 5. Medicine injection pen according to claim 4, CHARACTERIZED by the fact that said interruption assembly includes: an interruption member (36); said ratchet member (43) disposed within said stop member (36, 136); and an elastic member (41) urging said ratchet member (43) toward said driver (21, 121). [0006] 6. The medicine injection pen according to claim 5, CHARACTERIZED by the fact that said ratchet member (43) comprises a disc having a plurality of axially extending teeth (46) and keys (45) that extending outwardly from said disc are received by said stop member (36) to prevent rotation of said disc. [0007] 7. Medicine injection pen according to claim 5, CHARACTERIZED by the fact that said interruption member (36) receives protrusions (62) that extend axially on the inner surface (52) of said housing (1) to in order to prevent rotation of said interruption member (36). [0008] 8. Pen for medicine injection, according to claim 5, CHARACTERIZED by the fact that an opening (39) in said interruption member (36) receives said lead screw (23), said opening (39) preventing the rotation of said lead screw (23). [0009] 9. Medicine injection pen, according to claim 4, CHARACTERIZED by the fact that said actuator (21) is partially threaded to turn said lead screw (23). [0010] 10. Medicine injection pen, according to claim 1, CHARACTERIZED by the fact that during dose adjustment, the dose adjustment knob is prevented from being turned to adjust a dose that is greater than the remaining amount of medicine . [0011] The drug injection pen according to claim 1, characterized in that it further comprises a dose stopping member that prevents adjustment of a dose that is greater than the remaining amount of drug. [0012] 12. Pen for drug injection, according to claim 1, CHARACTERIZED by additionally comprising last dose management.
类似技术:
公开号 | 公开日 | 专利标题 BR112014022666B1|2021-05-04|medicine injection pen JP2019193857A|2019-11-07|Multiple use disposable injection pen CN108578834B|2021-01-08|Injection device JP5917769B2|2016-05-18|Drug delivery device BR112012013340B1|2021-05-04|Injection pen with measuring reflux and last dose control JP2019093188A|2019-06-20|Injection pen KR20160138461A|2016-12-05|Fluid delivery pen with final dose stop and improved dose setting features US10413674B2|2019-09-17|Injection device JP6412963B2|2018-10-24|Multi-use disposable injection pen TWI629080B|2018-07-11|Medicament delivery device ES2786575T3|2020-10-13|Drug delivery device for liquid pharmaceuticals
同族专利:
公开号 | 公开日 EP2825227B1|2019-05-01| WO2013137893A1|2013-09-19| JP2015513925A|2015-05-18| JP6368703B2|2018-08-01| DK2825227T3|2019-07-29| RU2608908C2|2017-01-26| US20150112274A1|2015-04-23| US9295782B2|2016-03-29| PL2825227T3|2019-10-31| IN2014DN07773A|2015-05-15| EP2825227A4|2015-08-19| RU2014141299A|2016-05-10| CN204337431U|2015-05-20| EP3527245A1|2019-08-21| EP2825227A1|2015-01-21| ES2736965T3|2020-01-09|
引用文献:
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法律状态:
2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]| 2019-11-05| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]| 2020-10-13| B07A| Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]| 2021-03-16| B09A| Decision: intention to grant [chapter 9.1 patent gazette]| 2021-05-04| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 15/03/2012, OBSERVADAS AS CONDICOES LEGAIS. |
优先权:
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申请号 | 申请日 | 专利标题 PCT/US2012/029306|WO2013137893A1|2012-03-15|2012-03-15|Multiple use disposable injection pen| 相关专利
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