• 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:
    The invention relates to an adjusting device for adjusting an injection device for delivering a metered dose of a drug from a container containing an axially displaceable piston. The adjusting device is arranged for automated pre-adjustment of a piston rod which cooperates with the piston, thereby monitoring the torque applied by the adjusting device on the piston rod.
    公开号:DK201600150U1
    申请号:DK201600150U
    申请日:2016-12-20
    公开日:2017-01-13
    发明作者:Claus Urup Gjødesen；Kim Rønnow Sejtzer
    申请人:Novo Nordisk As；
    IPC主号:
    专利说明:

    ADJUSTING DEVICE FOR ADJUSTING AN INJECTION DEVICE FOR DELIVERING A MEASURED DOSAGE OF A MEDICINE FROM A CONTAINER
    The present invention relates to an adjusting device for use during the assembly process of an injection apparatus, wherein the injection apparatus is of the type adapted to deliver one or more metered doses of a drug from a drug container. The present invention relates particularly to pen-type injectors.
    Pen-type injection devices are described, for example, in WO 2014/161952, particularly in connection with the example shown in connection with FIG. 1-5 of said reference. The apparatus comprises a drug-containing cartridge containing a displaceable rubber piston. The apparatus further comprises a dose setting mechanism and a dose delivery mechanism. In a functional apparatus, the rubber piston interacts with a piston rod to deliver a preset dose of the drug. The apparatus further comprises a so-called end-of-content limiter which ensures that the user of the apparatus is prevented from setting a dose in excess of the residual amount of the drug currently contained in the cartridge. The end-of-content limiter thus determines the total amount of dispensable injection for each injection device. When a pre-filled cartridge is first inserted the device typically has a distance between piston rod and rubber piston. Due to tolerance variation for the individual components contained in the apparatus, including the cartridge, the distance between piston rod and rubber piston (clearance) will typically vary from one production copy of the apparatus to the other. Typically, the tolerance variation can be primarily attributed to the variation of the rubber piston axial position in the cartridge during the filling process itself. Before the apparatus can be used to accurately deliver a set dose of the drug, it is necessary for the piston rod to abut against the rubber piston. To ensure this, an adjustment process is typically performed to minimize and ultimately eliminate the clearance between the piston rod and the inserted cartridge. This adjustment process represents a so-called priming of the injection apparatus. The adjustment process may consist of a sequence of operations which may include a dose setting operation followed by a dose delivery operation (injection) for the set dose.
    The adjustment process can be done manually by a user by mounting an injection needle for a new injection device and then repetitively adjusting a smaller dose followed by a dose delivery until fluid is ejected via the needle.
    Alternatively, an adjustment process can already be done via an automated process when producing the injection apparatus. In an automated process where two or more sub-assemblies for the injection apparatus are in a state which is not yet completed, such an adjustment process is performed, for example, to include an initial position measurement for piston and piston rod. The initial position measurement provides an estimate of the distance the piston rod would have to be displaced to eliminate the axial clearance which would occur between the piston and piston rod if the injection device were assembled. Based on the estimate of the distance between piston and piston rod, the adjustment sequence will typically comprise moving a dose setting element for the dose setting mechanism to an extent corresponding to the estimate of the distance between piston rod and piston. Subsequently, the piston rod can be moved axially by the dose delivery mechanism, typically by activating an injection button on the apparatus. However, traditional automated adjustment methods leave the potential for improvement.
    With the manufacture, it is desired to provide an adjustment device for an injection apparatus which, already in production of the injection apparatus, enables an adjustment of the injection apparatus so that the plunger rod abuts in a predefined manner against the plunger in the drug container. Therefore, the injector will either be fully primed so that the user of the injector is not required to perform additional operation steps prior to dose setting and injection, or need only perform a predetermined priming that does not vary among individual specimens for the injector.
    Further, it is desired to provide an adjusting device for an injection device which, in the production of a large number of injection devices, produces a more uniform amount of total dispensable injection volume for the individual injection devices.
    One or more of the foregoing objects is achieved with the production as set forth in claim 1.
    Further advantageous embodiments of the invention are obtained with an adjusting device as defined in the dependent claims. In particular embodiments of the manufacture, an industrially applicable adjustment is obtained for an injector in which the user experiences a fully primed device, ie. where there is contact between piston rod and piston in the container, even when the injector is first used.
    The invention will now be described in more detail with reference to the drawing, in which: FIG. 1 shows a prior art injector of a type shown in WO 2014/161952 suitable for use with the adjustment device according to the invention; 2 is an exploded view of components of the prior art injector 200 shown in FIG. 1, FIG. 3A and 3B show cross-sectional drawings of the prior art injector 200 shown in FIG. 1 in two states; FIG. 4A - 4C and FIGS. 5 shows selected components of the prior art injector 200 shown in FIG. 1, FIG. 6 is a schematic representation of an adjusting device according to the provision for adjusting a subassembly 200a for the prior art injector 200 shown in FIG. 1, FIG. 7 is a graph showing the torque applied as a function of reversed rotation of piston rod 220 for a given cartridge; FIG. 8 is a graph containing (I) a curve representing the distribution of the total dispensable quantity for a number of unadjusted injectors and (II) a graph representing the distribution of the total dispensable quantity for a number of adjusted injectors; and FIG. . 9 shows results for an example of an algorithm for use in connection with an adjustment device according to the invention.
    Fig. 1 shows a prior art injector 200 of the type described in connection with Figs. 2-5 in WO 2014/161952 Al. The injector 200 contains a drug-containing cartridge, the cartridge comprising an axially displaceable rubber piston. The injector 200 is designed as an injection pen and configured as an auto-injector of the type where a torsion spring stores energy during the setting of a dose and where the stored energy in the torsion spring, upon activation of the pen, releases and propels a piston rod. A dose setting element 280 is used to set a dose and a trigger button 290 is used to activate the delivery of the set dose. The described auto-injector is intended to deliver a number of separate dose administrations. These administrations can be continued until an end-of-content mechanism prevents the user from setting additional doses for delivery, ie. when the residual amount of the cartridge is below a given level which is not suitable for further drug delivery.
    FIG. 2 to FIG. 5 corresponds to the corresponding figures in WO 2014/161952 A1, and shows the components and design details of the injection pen 200. The reference numbers used in this specification generally correspond to the reference numbers used in WO 2014/161952 A1. For a complete description of components and functions of the injection pen 200, see the description in WO 2014/161952 A1.
    The injection pen 200 comprises a housing 201,210 defining an internal thread 226. A housing 213 containing a medicament is embedded in the housing. The container is of the cartridge type defining a longitudinal axis and containing a movable piston 214 which is axially movable in the distal direction against a septum mounted at the distal end of the container. The septum is arranged to be penetrated by an injection needle when attached to the injection pen 200.
    A plunger rod 220 comprising a plunger foot 227 is adapted to propel the plunger of the cartridge 213, the plunger rod defining along its longitudinal axis a thread engaging with the threads of the housing such that rotation of the plunger rod 220 relative to the housing 201,210 causes piston rod 220 is displaced relative to housing 201,210 in a longitudinal direction. Furthermore, the piston rod 220 defines an axially extending guide along its longitudinal axis. A pivot member 230 pivotally mounted relative to the housing engaging the axially extending guide of the piston rod such that piston rod 220 is rotatably locked but axially displaceable relative to the drive member 230.
    A one-way ratchet mechanism 205,235 is configured to interconnect the drive member 230 and housing 201,210 with each other for rotation of the piston rod 220 in a first direction of rotation (in the example in a counterclockwise direction from the button end of the pen).
    FIG. 6 is a schematic representation of an adjusting device for adjusting an injector 200 as described above. The adjustment device is intended to automatically adjust the injector as part of an automated assembly process.
    The injector 200 is shown in a state of production which, by assembly, is prepared in a sub-assembly 200a, but the release button 290 is not yet mounted relative to the remaining portion of the injector 200. In the condition shown, the sub-assembly 200a contains all components of the dose setting mechanism and the dose delivery mechanism in a operable state which enables dose setting and dose delivery. Sub-assembly 200a further includes a cartridge comprising a piston 214 disposed at a position where the piston occupies a position at a given axial distance from piston rod 220/227.
    This generation takes advantage of the condition of sub-assembly 200a where the release button 290 is not yet mounted that the piston rod 220 at its proximal end is accessible for manipulation. Similarly, the proximal end of reset tube 260 is available for manipulation. By using a tool adapted to rotorically engage the piston rod 220, and arranged to axially engage the reset tube 260, it is possible to rotate the piston rod 220 relative to the threads of the housing.
    For sub-assembly 200a, a prerequisite for the piston rod to be released for rotation is that the coupling member 240 is in its distal position corresponding to the condition shown in FIG. 3B. In the injector 200, reset tube 260, ratchet tube 250, and coupling element 240 constitute a subassembly of components moving together in the axial direction. By moving the reset tube 260 in the distal direction so that the coupling member 240 is in its distal position, it is possible for the drive member 230 to rotate relative to the housing 201,210. When turning the piston rod in a counterclockwise direction (viewed from the button end of the pen), the drive element 230 and the coupling element 240 rotate. Twisting of the coupling member 240 in a counterclockwise direction takes place by operating ratchet mechanism 252, 242 in incremental motion corresponding to 1 IU of rotor motion per second. step (15 degree rotation per step). By forcing the piston rod for counterclockwise rotation, the drive member 230 and the coupling member 240 are moved in 15 degree increments by simultaneous rotation under the cooperation of ratchet mechanism 252/242 and ratchet mechanism 205/235. End-of-content limiter 228 is rotorically locked to reset tube 260 and threaded with plunger pliers. When the piston rod is rotated in a counterclockwise direction, the threaded engagement of the piston rod with the housing 201 causes the piston rod to move in the distal direction, while End-of-content limiter 228 is not moved. Turning the piston rod 220 therefore causes the piston rod to move toward and closer to the stops formed on the end-of-content limiter 228, which are intended to cooperate with stop geometries formed on the piston rod. This reduces the remaining possible rotation of the piston rod 220.
    The adjusting device 1100 comprises a fixture 1110, an adjusting element 1120, a first actuator 1130, a monitoring unit 1140 and a control system 1150. The adjusting device 1100 further comprises a fixture 1170 and a second actuator 160, which handles the selection, transport and retention of the individual specimens under assemblies 200a. When a sub-assembly 200a is transported to an adjusting device 1100, the sub-assembly 200a is held relative to the adjusting device 1100 by the fixture 1170 which grips a housing portion of the sub-assembly 200a.
    The adjusting member 1120 contains a component which cooperates with the reset tube 260, so that when the adjusting member 1120 is moved in the distal direction, the reset tube 260 is pushed from a proximal position to a distal position. This releases the piston rod 220 for rotary movement in a counterclockwise direction.
    The adjusting member 1120 comprises a geometry which connects to the proximal end of the piston rod 220 and which is adapted to transfer rotation from the adjusting member to the piston rod so that the piston rod is rotorically driven by the adjusting member 1120.
    The adjustment element 1120 is driven by the actuator 1130 which is controlled by the control system 1150. A monitoring unit 1140 monitors the axial and rotor position of the piston rod 220. In addition, the monitoring unit 1140 is adapted to measure the torque applied by the actuator 1130 on the adjustment element 1120. The control system 1150 is coupled to the monitoring unit 1140, and is configured to control the actuator 1130 on the basis of position-related data and torque data.
    With a current sub-assembly 200a held in the adjusting device 1100, the piston rod 220 for sub-assembly 200a is positioned at an initial axial distance from the piston 214 of the cartridge 213.
    The adjusting device 1100 is arranged, via the actuator 1130, to rotate the piston rod 220 while simultaneously monitoring the piston rod position as well as the applied torque on the piston rod. When, after a given rotation of the piston rod, the applied torque starts to rise to an extraordinary degree and reaches a predetermined set level, it is an indication that the piston rod 220 (and its piston foot 227) abuts the piston 214, and rotation of the actuator 1130 may stopped. Thereafter, the adjustment element 1120 can be disconnected from the piston rod and reset tube 260 can be returned to the proximal position. This completes the adjustment process. As a result, the current sub-assembly 200a is brought into a primed state.
    After the adjustment process, the release button 290 is mounted relative to the sub-assembly 200a and the injector 200 is then prepared for the final process steps, including packing and redistribution.
    In the adjustment process, an adjusted injector is obtained, where the user experiences a fully primed injector, ie. where there is contact between piston rod 220/227 and piston 214, already when the injector is first used. Examples of applications for the above-described adjusting device for adjusting an injection device, i.e. for a given type of cartridge and for a given type of injection device. It should be noted that the measurements given in these examples are given as application examples only, and that the parameters and measured values given can be varied to suit the given choice of system components and for the given application. EXAMPLE 1
    FIG. 7 shows measurements made on a specimen of a sub-assembly 200a disposed in an adjustment unit 1100.
    Sub-assembly 200a contains a 3 mL PenFill® cartridge containing a U100 insulin drug. Under-assembly 200a is intended for an auto-injector 200, in which the user has the option to dispense a minimum of 300 units of insulin. Piston rod 220 and end-of-content limiter 228 are dimensioned for rotation of each other corresponding to max. 326 units, ie. corresponding to 326 increments of 15 degree angular rotation. Prior to the start of the adjustment process, assembly 200a has undergone a 10 unit functional check corresponding to 150 degree rotation. After this, 316 units remain before the end-of-content stop occurs. In FIG. 7, there is shown a graph showing the applied torque as a function of reversed rotation of the piston rod 220 in a given sub-assembly 200a. In the given example, the initial position after function check for piston rod 220 is indicated as 0 degree rotation.
    The torque curve exhibits a generally saw-toothed course in which the torque fluctuates for each 15 degree rotation as the piston rod rotates counterclockwise. This periodic fluctuation of 15 degree angular rotation corresponds to a piston rod movement of a size equal to 1 unit (IU) of drug delivered. The periodic fluctuation for each 15 degree rotation of the piston rod is a result of the ratchet element arm 252 cooperating with the teeth 242 of the coupling member 240, and the ratchet 235 interacting with the teeth 205 in the housing 201. In the example shown, the piston rod is rotated 180 degrees. corresponding to 12 units before the applied torque begins to rise extraordinarily. Next, the piston rod 220 bumps the piston 214 in the cartridge and upon further rotation the piston rod begins to compress the system, including the piston 214 in the cartridge. Depending on the degree of compression considered acceptable for the given application, a desired predefined upper limit of torque can be determined. When the measured torque exceeds the predefined upper limit value for the torque, the actuator 1130 is stopped. As an example of a predefined limit value, the maximum torque can be selected as 12 Nmm. In the case shown, the maximum torque will occur at approx. 184 degree rotation, equivalent to 12 full unit rotation. Then 304 units of dosing remain before the end-of-content stop occurs.
    The predetermined upper limit value for the torque of 12 Nmm selected in the experiment is to be seen as a non-limiting example only. Alternatively, for the conditions of the selected injector, a predefined upper limit value of the order of 20-30 Nmm may be selected, which typically corresponds to a compression of a size corresponding to a drug delivery of 2-3 units (IU). Studies have shown that for said type of autoinjector, a compression of the system in the order of 1-3 IU will be acceptable and will not give rise to any significant drug delivery when an injection needle is later applied, provided that a certain rest period is over since the compression. The experiments have shown that under resting conditions, ie. at low temperature and after the adjustment process is completed so that the piston rod is not driven further in the axial direction, after a period of approximately We hour duration, a stable state of the system where the liquid pressure in the cartridge is equalized occurs. The offsetting of the temporarily increased fluid pressure is due to the system's components, including the rubber piston 214, relaxing and achieving a steady state during the rest period. In practice, the control system 1150 can, via monitoring of the torque curve, ensure that the rotation of the piston rod is stopped within a certain angular interval between the individual peaks on the torque curve. This is to ensure proper engagement of the teeth 241 of the coupling element with the teeth 204 of the housing 201 when reset tube 260 is returned to the proximal position, similar to the condition shown in FIG. 3A. EXAMPLE 2 In this example, a number of sub-assemblies 200a which are of the same type as in Example 1. are used. Due to tolerance variation, primarily for the load quantity in the individual cartridges, due to the end-of-content limiter 228, a variation in the amount of the total dispensable number of drug from the individual auto-injectors 200. For a typical type of cartridge, this results in a distribution of the total dispensable amount of drug shown in FIG. 8, curve I. While most auto-injectors 200 are capable of delivering on the order of 305 to 309 units of drug, the total dispensable number of units for all auto-injectors varies between 302 to 312 units of drug. As uniformity of individual copies of an industrial product is often linked to perceived quality, it will typically be preferable to minimize said variation for total dispensable amount of drug from an injector. By using an adjusting device, as described above, this can be achieved. In Example 1, only a predefined upper limit value for the applied torque was used as a stop criterion. In Example 2, an adjusting device 1100 is used, where in the control system 1150 an algorithm is implemented which involves the magnitude of the angular rotation of the piston rod 220 as an additional stopping criterion. In the example shown, the angular rotation may not exceed 12 units of rotation. In addition, the stop criterion for the upper limit value of the applied torque is changed dynamically by decreasing the limit value as a function of obtained angular rotation. Hereby, the distribution for the total amount of dispensable drug from the auto-injectors 200 can be changed to exhibit a distribution as shown in FIG. 8, curve II.
    The algorithm of the control system 1150 can be configured to display those in the table in FIG. 9 characteristics. Here, it is sought to adapt the individual auto-injectors 200 to deliver a total dispensable amount of drug as close to 302 units (IU) as possible, without introducing undesirable effects.
    For example, if an auto-injector 200 with a cartridge containing 309 units of drug is inserted into the adjustment device 1100, the algorithm will ensure that the torque does not exceed 25 Nmm when the actuator 1130 drives the piston pliers rotor. This already occurs at an angular rotation of the piston rod corresponding to 10 units of rotation and causes a pre-compression of the system of 3 units (IU). For the system, this will be an acceptable pre-compression and will not produce undesirable effects. Although the cartridge contains 309 units, only 306 units can be set and dispensed until the end-of-content limiter 228 stops for further dose settings. In the event that an auto-injector 200 with a cartridge containing 307 units of drug is inserted into the adjusting device 1100, the algorithm will ensure that the angular rotation is stopped after 12 units of rotation. The angular rotation is not stopped earlier as the torque applied at 11 units of rotation did not exceed 25 Nmm. In this case, a 2-unit (IU) system is pre-compressed which will be acceptable as this does not exhibit unwanted effects. Although the cartridge contains 306 units, only 304 units can be set and dosed until the end-of-content limiter 228 stops for further dose settings. In the event that an auto-injector 200 with a cartridge containing 305 units of drug is inserted into the adjusting device 1100, the algorithm will ensure that the angular rotation is stopped after 12 units of rotation. The angular rotation is not stopped earlier because the torque applied at 11 units of rotation did not exceed 18 Nmm and because the torque applied at 10 units of rotation did not exceed 25 Nmm. This corresponds to a compression of the system of 1 unit (IU) which will be an acceptable pre-compression of the system which does not exhibit undesirable effects. Although the cartridge contains 306 units, only 304 units can be set and dosed until the end-of-content limiter 228 stops for further dose settings. In the event that an auto-injector 200 with a cartridge containing 304 units of drug is inserted in the adjusting device 1100, the stop criterion for maximum torque will not occur and the algorithm will ensure that the angular rotation does not exceed 12 units of rotation. Here, the piston foot 227 will engage the piston 214 without pre-compressing the system. 304 units will be adjustable and dosed until the end-of-content limiter 228 stops for additional dose settings. In the event that an auto-injector 200 with a cartridge containing 302 units of drug is inserted in the adjusting device 1100, the stop criterion for maximum torque will not occur and the algorithm will ensure that the angular rotation does not exceed 12 units of rotation. Here, the plunger foot 227 will not touch the plunger 214 but will stop for 2 units from the plunger. The end-of-content limiter 228 stops when the user has set a total of 304 units, of which the first two will be in the form of a liquid-free priming, while the remaining 302 units will be in liquid delivery.
    By implementing the outlined algorithm involving the angular rotation of the piston rod 220 as an additional stopping criterion, the distribution of dispensable amount of drug from the injectors 200 can be changed from curve I to curve II. Thereby, the uniformity of the total dispensable male drug for the injectors 200 will be markedly improved.
    权利要求:
    Claims (4)
    [1]
    An adjusting device for adjusting an injection device for delivering a metered dose of a drug from a container, the injection device (200) comprising: - a housing (201,210) defining an internal thread (226), - a container (213) defining a longitudinal axis and containing a medicament wherein the container comprises an axially displaceable piston (214), - a piston rod (220,227) arranged to propel the piston (214) into the container (213), wherein the piston rod defines a thread along its longitudinal axis. threaded with the housing thread so that piston rod (220,227) rotation relative to housing (201,210) causes the piston rod (220) to be displaced relative to the housing (201,210) in a longitudinal direction; and wherein the piston rod (220,227) defines along its longitudinal axis an axially extending guide, a drive member (230) pivotally mounted relative to the housing and engaging the axially extending guide of the piston rod such that the piston rod (220,227) is rotatable. locked but axially displaceable relative to the drive means (230); and - a one-way ratchet mechanism (205,235) interconnecting the drive element (230) and housing (201,210) to rotate the piston rod in a first direction of rotation; wherein the adjusting device (1100) is new in that it comprises: an adjusting element (1120) arranged for releasably coupling relative to the piston rod (220,227) for rotating the piston rod, - an actuator (1130) coupled to the adjusting element and arranged for rotatably driving the adjusting element (1120) for propelling the piston rod (220) in the first direction of rotation, - a monitoring device (1140) arranged to generate data indicative of one or more parameters selected from the group comprising: a) the position of the piston rod (220,227), b the torque applied by the actuator (1130) to the adjusting element (1120), and c) the axial pressure applied by the actuator (1130) to the piston rod (220,227), and - a control system (1150) coupled to the actuator (1130) and to the monitoring device ( 1140) for controlled rotation of the adjustment element (1120) based on data generated by the monitoring device (1140).
    [2]
    Adjusting device according to claim 1, which is new in that the adjusting device (1100) is arranged to drive via the actuator (1130) the adjusting element (1120) based on data generated by the monitoring device (1140), thereby propelling the piston rod (220.227) from a state where there is axial distance between the piston rod and the piston to a state where the piston rod engages the piston.
    [3]
    Adjusting device according to claim 1, which is new in that the adjusting device (1100) is arranged to drive through the actuator (1130) the adjustment element (1120) based on data generated by the monitoring device (1140), thereby propelling the piston rod (220.227) from a state where there is an axial distance between the piston rod (220,227) and the piston (214) to a state where the piston rod engages the piston and affects the piston with a force of a predefined size.
    [4]
    Adjusting device according to claims 1-3, which is new in that the adjusting device is arranged to drive via the actuator the adjustment element based on data generated by the piston rod propulsion monitor (1140) and wherein the propulsion is stopped when it is actuated by the actuator (1130). ) applied to the adjusting element (1120) exceeds a limit value corresponding to a predefined torque.
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    同族专利:
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    引用文献:
    公开号 | 申请日 | 公开日 | 申请人 | 专利标题
    法律状态:
    优先权:
    申请号 | 申请日 | 专利标题
    DKBA201600150U|DK201600150Y3|2016-12-20|2016-12-20|ADJUSTMENT DEVICE FOR ADJUSTING an injection apparatus for delivering a metered dose of a medicament from a container|DKBA201600150U| DK201600150Y3|2016-12-20|2016-12-20|ADJUSTMENT DEVICE FOR ADJUSTING an injection apparatus for delivering a metered dose of a medicament from a container|
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