• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    AUTOMATIC APPLICATOR FOR LIQUID PHARMACEUTICAL PREPARATIONS, PARTICULARLY FOR INSULIN. The present invention relates to an automatic applicator for liquids and pharmaceutical preparations, particularly for insulin, and more particularly for multiple injection with adjusted doses of a medicinal product from a changeable container, which comprises a body housing (1 ) connected to a housing (2) of a changeable container that contains a medicine, particularly insulin, which has a plunger (12), suitable for expelling the medicine, said plunger (12) displaced only linearly by means of a drive unit integrated suitable for mobilizing, driving, linearly driving and blocking the rotation of said piston (12), activated via a double-acting clutch, by a tensioning spring (15) located in the body housing (1) said tensioned spring (15) by a rotary ring (3) for manual dose adjustment via the same double-acting clutch unit, where said drive unit is activated by a trigger unit (13) and a dose is indicated by r an indicating device according to the present invention, comprising at least one locking key (5,6) disposed in the upper part of the barrel (5) with rack, collaborating with at least one key (1,3) disposed in the part of the cylindrical housing body (1).
    公开号:BR112012005853B1
    申请号:R112012005853-3
    申请日:2010-03-29
    公开日:2020-10-20
    发明作者:Adam STEFANSKI
    申请人:Copernicus Sp. Z O.O.；
    IPC主号:
    专利说明:

    [001] The present invention relates to an automatic applicator for liquid pharmaceutical preparations, particularly for insulin, more particularly for multiple injection with adjusted doses of a medicinal product from a changeable container, for example, for self-application of insulin by diabetic patients.
    [002] European Patent EP 0 338 806 Bl (to Holman and Marchall) demonstrates a syringe comprising a body, a dose adjustment device in the form of a rotating cover or ring mounted on the body and capable of being moved to a selected adjustment position where a latch is arranged to retain the adjustment device in such an adjustment position, the movement of the adjustment device being accompanied by the tension of a spring, which, when the latch is released, provides the force to expel the adjusted dose, characterized by means arranged to release the latch, which causes the adjustment device to return to its original position to drive a plunger through a one-way clutch to expel the adjusted dose; and by a threaded arrangement with a quick-thread screw capable of transforming the rotation of the adjustment device into a linear movement of the piston.
    [003] Also the Polish Patent Application P 341 395 demonstrates a syringe for the distribution of adjusted doses of a medicinal product from a cartridge that contains the quantity of the medicinal product sufficient to prepare several treatment doses, which comprises a housing, a piston-like rod having a non-circular cross-section and an external threaded screw, a piston-like rod drive arrangement comprising two elements, i.e., piston-like rod conductors and a nut with an internal threaded screw corresponding to the external threaded piston rod screw, as well as a dose adjustment mechanism comprising a threaded connection with a non-self-locking screw along which an injection push button is unscrewed from the nearest housing end, causing the dose adjustment element to rotate. This syringe is characterized by the fact that, between the nut and the piston, there are conductors of uni-directional coupling rods that allow the rotation of both these parts in one direction, but not in the opposite direction, where the permitted rotation is the only rotation, by means of which the piston rod is moved in the direction of the circumference in the syringe. The coupling is designed in such a way that the initial resistance, sufficient to resist the torque exerted on the coupling by adjusting a dose, has to be overcome to allow rotation. The markings indicating the size of the selected dose could be placed under the housing.
    [004] The main disadvantage of known devices is the lack of provision for the application of a precisely controlled and adjusted dose of a drug.
    [005] The syringe discussed above for manual application of a drug requires a patient to manually adjust the pressure force on the push button of the injection, which defines the injection speed. This causes additional annoying wear and discomfort when applying. An additional disadvantage is the complex arrangement for transforming the linear displacement of the injection push button into the linear displacement of the piston rod by rotating the nut. Other disadvantages of a syringe for a drug application using a tension spring include the failure-prone construction of the trigger device, which does not guarantee reliable locking of the nut, and the lack of an external guide means for the tension spring. This has a negative effect on maintaining control and accuracy of applying the adjusted dose of a drug.
    [006] Furthermore, the known devices do not guarantee adequate protection against damage to the clutch or the drive arrangement due to excessive rotation of the dose adjustment element. Also, the frictional forces that oppose the plunger action are very large. The arrangements for indicating the dose, in known devices, are very complex and the scale usually placed on the external surface of the housing can be easily erased.
    [007] The main target of the present invention with respect to an automatic applicator particularly for insulin, more particularly for multiple application of injection of adjusted doses from an exchangeable container, is to guarantee a capacity for the precisely controlled application of the dose adjusted of a medicine, preserving an automatic application of the medicine without any uncomfortable wear, providing an external guide for the tensioned spring and providing adequate protection against damage of the clutch or of the drive arrangement due to the excessive rotation of the dose adjustment element.
    [008] The second aim of the invention is to guarantee the reduction of frictional forces that oppose the plunger action, and to provide the reliable locking of the nut through a reliable construction of a trigger device, preserving the application automatic medication.
    [009] The third target of the present invention regarding an automatic applicator is to guarantee an indicating device that has the scale markings not placed on the external surface of the housing, which prevents them from being erased during the operation of the applicator by its user .
    [010] The main objective of the present invention has been achieved by an automatic applicator for liquid pharmaceutical preparations, particularly for insulin, more particularly for multiple injection with adjusted doses of a medicinal product from an exchangeable container, comprising a housing body connected to a housing of a container exchangeable with a medicine, particularly insulin, which has a plunger, suitable for expelling the medicine, said plunger being moved only linearly by means of an integrated actuation unit, suitable for immobilizing, activating, drive linearly and block the rotation of said piston, activated via a double-acting clutch, by a tension spring located in the housing body, said spring tensioned by a rotating manual dose adjustment ring via the same double-acting clutch unit , where said trigger unit is activated by a trigger unit, and a dose being indicated by an indicator arrangement. According to the present invention, said automatic applicator is characterized in claim 1 in that it comprises a locking key arranged on the top of the rack-mounted barrel, collaborating with at least one key arranged on the inside of the cylindrical housing body.
    [011] The new construction of the automatic applicator allows precisely controlled application of the adjusted dose of a medicine, preserving an automatic application of the medicine without any effort, providing an externally guided action for the tensioned spring and providing adequate protection against damage clutch or drive arrangement due to excessive rotation of the dose adjustment element.
    [012] Advantageously, the automatic applicator comprises two locking keys arranged directly on the surface of the circumference of the barrel with a rack, collaborating with two keys on the inside of the cylindrical surface of the cylindrical housing body, arranged above an inspection window.
    [013] The second objective of the present invention has been achieved by a variant of automatic applicator where the integrated drive unit, suitable for immobilizing, driving, linearly driving and blocking the piston rotation, comprises a piston locking guide and a lock nut. drive, while the piston locking guide is locked in a toothed ring of the seat element, forced on it by means of the container housing of the exchangeable insulin container, and in said integrated drive unit a nut is mounted in a way support on a seat element, advantageously by means of a ball bearing.
    [014] Due to such construction, there is the provision of a reliable locking nut lock, minimally affecting the positioning of the nut and simultaneously preventing any rotation of it or influencing the position of the plunger during dose adjustment, as well as it is ensured the reduction of frictional forces that oppose the piston action.
    [015] In addition, the actuating tension spring is advantageously a twisted spring and the second spring is arranged directly under the trigger unit.
    [016] The third objective of the present invention was achieved by a variant of automatic applicator in which the indicator arrangement comprises a scale deposited in a linear manner on a cylindrical part of the barrel with rack under the locking keys and an inspection window located in the housing . Due to such construction, the scale is shifted appropriately during dose adjustment and is clearly visible through the inspection window.
    [017] The present invention was presented in detail in the drawings, in the advantageous example of its configuration, where: - Figure 1 shows the longitudinal section of the automatic applicator, without a changeable container and its housing; - Figure 2 shows the cross section (B - B) of the rack mechanism of the automatic applicator with the tongues engaged with the toothed ring of the nut; - Figure 3 shows the cross section (C - C) of the automatic applicator, from Fig. 1, in the place where the trigger mechanism engages with the toothed ring of the nut; - Figure 4 shows the cross section (D - D) of the automatic applicator, from Fig. 1, showing the system that blocks the rotation of the scale, which defines the working range of the automatic applicator; - Figure 5 shows in pictorial way the cross section (E - E) of the automatic applicator, from Fig. 1, showing the positioning of the elements of the piston locking arrangement against rotation; - Figure 6 shows the axonometric front view of the automatic applicator, from Fig. 1, with parts of the housings removed, showing the mutual advantageous positioning of the elements of the internal mechanisms of the automatic applicator; and - Figure 7 shows the exploded axonometric front view of the automatic applicator, from Fig. 1.
    [018] As shown in Figs. 1, 6 and 7, an automatic applicator for liquid pharmaceutical preparations, particularly for insulin, more particularly for multiple injection with adjusted doses of a medicinal product from an exchangeable container, comprises the housing body (1), connected to the housing (2) of the exchangeable container with a medicine (not shown in the drawings). Insulin is expelled by the plunger (12), moved in a linear way by means of the actuation unit, suitable to immobilize, actuate, conduct linearly and block the rotation of the plunger (12), activated via a double-acting clutch unit by the spring (15) tensioner, where the actuation tensioner spring (15) is a twisted spring located in the housing body (1), tensioned by the rotating manual dose adjustment ring (3) via a double action clutch unit, where the drive unit is activated by the trigger unit (13) and the indicating cylinder that can be moved is located on the tension spring support (15), and a scale (5.7) with the scale visible through the inspection window (1.1) deposited on the barrel (5) with rack.
    [019] The automatic applicator for liquid pharmaceutical preparations, particularly for insulin, more particularly for multiple injection with adjusted doses of a medicinal product from an exchangeable container operates as follows:
    [020] To replace the insulin container, the housing container (2) must be unscrewed, which is connected with the housing body (1) - Fig. 1 - by turning it counterclockwise. After being unscrewed, the housing container (2), the piston locking guide (11) and the seat-type element (9) are automatically removed due to the pulling action of the spring (10) by moving the guide (11) plunger lock coaxially in the direction of the plunger (12). This makes it possible to manually return the plunger (12) by using force in the axial direction to push it into the housing (1). The end (12.1) of the plunger is rotated independently on the plunger (12). The coupling between the plunger (12) and the nut (7) is made by a quick thread, thus, while it is pushed into the housing (1) the plunger (12) is screwed into the nut (7). The plunger must be pushed until it almost disappears completely in the housing (1), which allows a new insulin container to be inserted.
    [021] The nut (7) is coupled with the plunger (12) by a thread that has a pitch that makes it possible to apply the appropriate dose of insulin. In addition, the nut (7) is mounted as a support on the seat-type element (9), advantageously by means of a ball bearing (8).
    [022] Then you can remove the needle (not shown) mounted on the container housing (2) by turning it counterclockwise, remove the empty container by unscrewing it from the housing (2) and install a new container.
    [023] To install a new container, it can be inserted into the container housing (2), which can be arranged in the body housing (1) by turning it clockwise. Then a new needle can be attached and covered with the protective cap.
    [024] The dose adjustment is carried out by turning the rotating manual dose adjustment ring (3), Fig. 1, clockwise. The adjusted dose of the moment can be seen on the cylindrical part of the barrel (5) with rack through the inspection window (1.1) located in the housing (1), which together with the scale (5.7) deposited linearly on the The bottom part of the locking keys (5.6) comprises the indicator arrangement. The barrel cylinder (5) with rack is staggered in every four units and the rotation of the rotary ring (3) of manual dose adjustment is accompanied by a characteristic clicking noise every two units, which corresponds to 0.02 ml of insulin. The dose adjustment can be carried out up to two units, where the scale (5.7) visible through the inspection window (1.1) stops at any value or between the given dose values, which are easy to check since two consecutive doses are then seen in the inspection window (1.1), and a red indication line shows the position between them.
    [025] The rotating manual dose adjustment ring (3) is rigidly connected to the coupling sleeve (6). When a dose is to be increased, the coupling sleeve (6) (Fig.2) is rotated clockwise (when looking in the direction of the needle) where the elastic arm of the tab (5.3) is moved over the sliding edges (7.4 ) of the rack tooth ring (7.1) of the stationary drive nut (7), from a locking edge (7.5) of the rack tooth ring (7.1) to the neighboring edge (s) depending rotation angle. The rack-mounted barrel (5) is driven by the coupling sleeve (6) through the pilot recess (6.1) made on the inner wall of the coupling sleeve (6) set with the key (5.4) located on the inner wall of the barrel ( 5) with rack. Therefore, when the coupling sleeve (6) is rotated, the rack barrel (5) is rotated along with it. During the clockwise rotation, the elastic arm of the tab (5.3) is moved radially inward and outward, alternately.
    [026] The rack-mounted barrel (5) is rigidly connected with the spring (15), which, in turn, is connected with the spring block (4). The spring block (4) is rigidly connected to the housing (1) and secured against rotation.
    [027] During dose adjustment the nut (7) is immobilized by the trigger unit (13) through the rectangular slits (7.7), Fig. 3, located on the circumference of the nut (7), which collaborates with the wrench (13.1) of the trigger unit (13).
    [028] The operating range of the automatic applicator is defined by two locking keys (5.6) - Fig. 4 - arranged directly on the surface of the circumference of the barrel (5) with rack, collaborating with two keys (1.3) on the inside the cylindrical surface of the cylindrical housing (1) above the inspection window (1.1). The keys are located on opposite sides and simultaneously shifted slightly in axial mode. Such an arrangement makes it possible to perform an incomplete rotation of the dose adjustment elements.
    [029] After dose adjustment, insulin dosage can be activated by pressing the trigger unit (13) in the direction of the needle. The trigger unit (13) could be pressed through the entire insulin delivery time. The trigger displacement range is defined by the displacement of the key (13.1) in the corresponding slot (1.2) in the body housing (1). After pressing the trigger unit (13) the nut (7) is released by wearing the ring with the rectangular slots (7.7) and the key (13.1) of the trigger unit (13). The mechanism starts the rotation, activated by the tension spring (15). The nut (7) unscrews the piston (12) from the thread (12.1) of the piston (12). The rotation of the piston is blocked by the key (11.1) of the guide (11) of the piston lock and recess (12.3) made in the piston (12) - Fig.5. The plunger (12) acts directly on the piston of the insulin container arranged in the container housing (2). It causes the injection of insulin from the needle mounted on the container housing (2). This action is accompanied by the reverse movement of the entire mechanism to its initial position, that is, the tension spring (15) unfolds and the barrel (5) with rack with the scale (5.7) returns to the "0" position.
    [030] After completing the dose adjustment, the trigger unit (13) can be released. The trigger unit (13) will then automatically return to its initial forced position by the spring (14), which is placed directly under the trigger unit (13), and will lock the nut (7) again.
    [031] The double action clutch, best seen in Fig. 2, which shows the cross section (B - B) of the automatic applicator rack mechanism with the tongues engaged with the toothed ring of the nut, comprises the sleeve (6 ) coupling coupled in radial mode with the barrel body (5) with rack and coupled with the tabs (5.3) that have hooks separately coupled with the rack tooth ring (7.1) of the drive nut (7).
    [032] The coupling sleeve (6) is rigidly connected with the manual dose adjustment rotating ring (3) and the barrel body (5) with rack is rigidly connected to the tension spring support (15) , in the form of a protective glove, which makes it possible to transfer rotation of the rotating ring (3) for manual dose adjustment to the support of the tension spring (15).
    [033] The tension spring (15), Fig. 1 and Fig. 6, is mounted, on the side of the needle, on the support of the tension spring (15), in the form of a protective sleeve rigidly connected to the barrel body. (5) with rack.
    [034] The integrated drive unit, Fig. 5, suitable for immobilizing, driving, linearly driving and blocking the piston rotation (12) comprises a piston blocking guide (11) and a drive nut (7). The construction of the integrated drive unit allows the piston (12) to be turned manually by pushing it into the drive nut (7) in such a way that it protrudes minimally into the housing, and allows for a new container, for example. example, insulin, be inserted.
    [035] The nut (7) - as mentioned above - is coupled to the plunger (12) by a thread that has a pitch that makes it possible to apply the appropriate dose of insulin. In addition, the piston (12) comprises at least one longitudinal slot that allows the linear displacement of the piston (12) in the guide (11) of the piston lock by means of at least one key.
    [036] The trigger unit, Fig. 3, constitutes the trigger (13) with the key (13.1) slidably moved in the slot (1.2) located in the housing (1) to lock the ring with the rectangular slots (7.7) the drive nut (7).
    权利要求:
    Claims (8)
    [0001]
    1. Automatic applicator for liquid pharmaceutical preparations, particularly for insulin, more particularly for multiple injection with adjusted doses of a medicinal product from a changeable container, comprising a body housing (1) connected to a housing (2) of a container exchangeable with a medication, particularly insulin, which has a plunger (12), said plunger (12) being moved only linearly by means of an integrated drive unit, activated via a double-acting clutch, by a spring ( 15) tensioner located in the body housing (1), said spring (15) tensioned by a rotating manual dose adjustment ring (3) via the same double-acting clutch unit comprising a coupling sleeve (6) coupled to the radial mode with a barrel body (5) with rack, where said drive unit is activated by a trigger unit (13), and a dose is indicated by an indicating device, characterized by co attach at least one locking key (5.6) arranged on the top of the barrel (5) with a rack, collaborating with at least one key (1.3) disposed on the inside of the cylindrical housing body (1).
    [0002]
    2. Applicator according to claim 1, characterized in that it comprises two locking keys (5.6) arranged directly on the surface at the circumference of the barrel (5) with a rack, collaborating with two keys (1.3) on the inside of the cylindrical surface the cylindrical housing body (1), arranged above an inspection window (1.1).
    [0003]
    Applicator according to claim 1, characterized in that the integrated drive unit comprises a nut (7) mounted as a support on a seat type element (9).
    [0004]
    4. Applicator according to claim 1, characterized in that the indicating device comprises the scale (5.7) deposited in a linear manner on a cylindrical part of the barrel (5) with rack under the locking keys (5.6) and window (1.1 ) inspection located in the housing (1).
    [0005]
    5. Applicator according to claim 1, characterized in that the integrated drive unit comprises a piston locking guide (11) and the drive nut (7).
    [0006]
    6. Applicator according to claim 5, characterized in that the piston locking guide (11) is locked in a toothed ring of the element (9) of the type of a seat forced against it by means of the housing container (2) the exchangeable insulin container.
    [0007]
    7. Applicator according to claim 1, characterized in that the actuating tension spring (15) is a twisted spring.
    [0008]
    8. Applicator according to claim 1, characterized in that the spring (14) is disposed directly below the trigger unit (13).
    类似技术:
    公开号 | 公开日 | 专利标题
    BR112012005853B1|2020-10-20|automatic applicator for liquid pharmaceutical preparations, particularly for insulin
    ES2322095T5|2017-09-11|Management device with display drum
    BR112012001421B1|2020-12-08|indicating mechanism for an automatic applicator, particularly for insulin
    DE69923095T2|2006-03-02|Inexpensive pen-shaped medicament syringe
    ES2754749T3|2020-04-20|Dosing and actuation mechanism for drug delivery device
    PT1372767E|2007-04-30|Drive mechanism for an injection device
    JP2008541907A|2008-11-27|Injection device with visual content end indication
    BRPI0911760B1|2021-05-25|DEVICE FOR DRUG ADMINISTRATION
    PT2274029E|2012-01-10|Medication delivery device
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    HU228441B1|2013-03-28|Improvements in and relating to an injection device
    PT1372770E|2007-01-31|Improvements in and relating to an injection device
    RU81072U1|2009-03-10|DEVICE FOR DOSED INJECTION OF MEDICINAL PRODUCT
    同族专利:
    公开号 | 公开日
    EP2913075A1|2015-09-02|
    BR112012005853B8|2021-06-22|
    CA2773242A1|2010-08-12|
    JP2015120003A|2015-07-02|
    CN102573962A|2012-07-11|
    RU2012117569A|2013-12-10|
    AU2010210090B2|2014-06-19|
    JP5802211B2|2015-10-28|
    CA2773242C|2019-03-12|
    KR20180061415A|2018-06-07|
    HK1169814A1|2013-02-08|
    RU2527156C2|2014-08-27|
    EP2493533A2|2012-09-05|
    CN102573962B|2014-03-05|
    EP3235531A1|2017-10-25|
    WO2010089418A3|2010-10-28|
    DK2493533T3|2015-05-18|
    AU2010210090A1|2012-04-05|
    US20120209208A1|2012-08-16|
    KR20120100965A|2012-09-12|
    DK2913075T3|2017-08-28|
    EP2913075B1|2017-05-03|
    JP2013509213A|2013-03-14|
    PL215310B1|2013-11-29|
    ES2536838T3|2015-05-29|
    WO2010089418A2|2010-08-12|
    US10064999B2|2018-09-04|
    KR101863938B1|2018-07-05|
    ES2635368T3|2017-10-03|
    US20170100547A1|2017-04-13|
    EP2493533B1|2015-02-25|
    US20190099556A1|2019-04-04|
    KR101988582B1|2019-06-12|
    BR112012005853A2|2017-06-06|
    US20180133406A1|2018-05-17|
    US9895495B2|2018-02-20|
    JP2017136426A|2017-08-10|
    US9566386B2|2017-02-14|
    PL389427A1|2011-05-09|
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    法律状态:
    2019-01-15| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-07-09| B06T| Formal requirements before examination [chapter 6.20 patent gazette]|
    2020-02-27| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|
    2020-07-14| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2020-10-20| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 20/10/2020, OBSERVADAS AS CONDICOES LEGAIS. |
    2021-06-22| B16C| Correction of notification of the grant|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 29/03/2010, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO |
    优先权:
    申请号 | 申请日 | 专利标题
    PLP.389427|2009-10-30|
    PL389427A|PL215310B1|2009-10-30|2009-10-30|Automatic applicator, especially for insulin|
    PCT/EP2010/054128|WO2010089418A2|2009-10-30|2010-03-29|Automatic applicator for liquid pharmaceutical preparations, particularly for insulin|
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