Injection Simulation Device

Abstract

The present disclosure provides an injection simulation device (100) operable to simulate the injection of a dose of a medication, the device comprising: a housing (110) defining a longitudinal direction (2, 3); a rotatable element (120) disposed within the housing (110), the rotatable element (120) being rotatable relative to the housing (110) and constrained to the housing (110) with respect to the longitudinal direction (2, 3); a trigger (111) manually operable by a user to initiate or control the simulated injection of the dose; and mechanical attachments to the trigger (111) and the rotatable element (120). the mechanical coupling (160) engaged with the trigger (111), the mechanical coupling (160) operable to induce or convert operation of the trigger (111) into rotation of the rotatable element (120) along a first rotational orientation relative to the housing (110); and a brake unit (140; 240; 340) fixed to the housing (110) and in torque-resistant engagement with the rotatable element (120), the brake unit (140; 240; 340) operable to apply a braking force or braking momentum to the rotatable element (120).

Description

[Technical Field]

[0001] The present disclosure relates to an injection simulation device, also indicated as an injection training device, and further to a method for simulating the injection of a dose of a medication. [Background technology]

[0002] Drug delivery devices for setting and expelling single or multiple doses of liquid medication are known in the art. Generally, such devices have much the same purpose as a conventional syringe.

[0003] Drug delivery devices, such as pen injectors, must meet several user-specific requirements. For example, in the case of patients suffering from chronic diseases such as diabetes, the patient may be physically weak and may also have impaired eyesight. Therefore, drug delivery devices, particularly those suitable for home medical use, must be robust in construction and easy to use. Furthermore, the operation and general handling of the device and its components should be clear and easy to understand. Such injection devices should provide for the setting and subsequent delivery of variable-sized doses of medication. Furthermore, the dose setting and dose delivery procedures must be easy to perform and clear.

[0004] For patients or users unfamiliar with using such injection devices, it would be beneficial to provide a training or simulation device that allows users or patients to train or simulate the process of dose setting and dose ejection or injection without having to inject a medication. In semi-automated or fully automated injection devices, as well as fully mechanically implemented devices such as injection pens, users may need to apply a significant ejection force to initiate and / or control the dose injection process. Here, the user may need to exert an ejection force greater than the inherent friction or reaction force of the injection device. Such reaction force or friction is primarily governed by the sliding and frictional engagement between the sidewall of the barrel of the medication container and a stopper or bung movably disposed within the barrel. Additionally, some medications may exhibit a relatively high viscosity. Therefore, a significant fluid or ejection pressure must be applied to propel the medication through an injection needle with a limited diameter.

[0005] It is therefore desirable to provide an injection training or simulation device that allows a user to train or simulate setting and / or expelling a dose. The simulation or training device should provide realistic mechanical feedback to the user. Thus, the simulation or training device should accurately mimic the operability of existing injection devices. The simulation or training device should be simple and intuitive to use. The simulation or training device should be fairly robust and long-lasting. The simulation or training device should also provide a kind of infinite feedback that does not require the user to reset after only a few uses. Summary of the Invention [Means for solving the problem]

[0006] In one aspect, the present disclosure relates to an injection simulation device operable to simulate the injection of a dose of a pharmaceutical agent. The injection simulation device includes a housing. The housing defines a longitudinal direction. The housing may be elongated in shape. The housing may be cylindrical or tubular in shape. The injection simulation device further includes a rotatable element disposed within the housing and rotatable relative to the housing. The rotatable element is longitudinally constrained to the housing. In some examples, the rotatable element is longitudinally locked to the housing. The rotatable element may be prevented from longitudinal movement relative to the housing.

[0007] The rotatable element may be movable, e.g., rotatable, relative to the housing only in the circumferential direction, but may be locked relative to the housing in the longitudinal direction. In other words, the rotatable element may be free to rotate relative to the housing about a rotation axis that typically extends longitudinally or parallel to the longitudinal direction. The rotatable element may be fixed longitudinally relative to the housing and prevented from translating longitudinally relative to the housing.

[0008] The injection simulation device further includes a trigger manually operable by a user to initiate and / or control the simulated injection of the dose, hi some examples, the trigger may be manually operable by a user to initiate and control the simulated injection of the dose.

[0009] The injection simulation device further includes a mechanical coupling mechanically engaged with the trigger and the rotatable element. The mechanical coupling is operable to induce or translate actuation of the trigger into rotation of the rotatable element along a first rotational orientation relative to the housing. In this manner, the mechanical coupling enables actuation of the trigger to cause or result in rotation of the rotatable element along the first rotational orientation. In some examples, actuation of the trigger may involve user-initiated movement of the trigger relative to the housing, e.g., in a distal direction, which movement of the trigger may be translated, via the mechanical coupling, into rotation of the rotatable element along the first rotational orientation relative to the housing.

[0010] The injection simulation device further comprises a brake unit fixed to the housing and in torque-resistant engagement with the rotatable element. The brake unit is operable to apply a braking force or braking momentum to the rotatable element. In particular, the brake unit simulates and / or provides a counter force acting on the rotatable element, which counter force or momentum mimics the mechanical resistance of an injection device, such as mechanical resistance that may be due to the viscosity of the medicament being propelled or expelled through the outlet of the medicament container and / or the infusion needle, as well as the mechanical resistance provided by a stopper or bung that sealingly engages the barrel of the medicament container and that must be displaced distally relative to the barrel to expel the dose of medicament.

[0011] The brake unit may be longitudinally fixed to the housing. The brake unit may be provided as a separate part and / or as an enclosed unit suitable for placement and fixing within the housing of the injection device, the injection device being able to adapt the function of the injection simulation device by the installation of the brake unit.

[0012] The brake unit is configured to provide a well-defined braking force or braking momentum when the rotatable element is subjected to a rotation caused by a trigger of the injection simulation device. The brake unit may be operable to provide a braking force or braking momentum regardless of the angular position of the rotatable element. In this manner, the injection simulation device does not need to be manually reset by a user, for example, after performing or running an injection simulation. Additionally, the brake unit may be wear-free. Thus, the injection simulation device and brake unit may be quite long-lasting and may provide consistent functionality throughout the life of the injection simulation device.

[0013] In another example, the braking unit of the injection simulation device is operable to apply a variable magnitude braking force or braking momentum to the rotatable element, where the magnitude of the braking force or braking momentum varies depending on the angular velocity of the rotatable element relative to the housing. In this manner, a velocity-dependent braking force or braking momentum can be provided to the rotatable element, thereby providing a highly realistic simulation of the injection procedure and associated reaction forces. The reaction forces are primarily due to friction between the stopper or bung and the sidewall of the cartridge or barrel of the drug container, as well as the viscosity of the injectable fluid being expelled through the outlet and / or an injection needle connected to the outlet of the drug container.

[0014] Generally, the brake unit can be implemented in a number of different ways. The brake unit is specifically adapted and configured to apply a braking force or momentum to a rotatable element that is longitudinally immobile and rotatably supported only relative to the housing of the injection simulation device. This longitudinal constraint of the rotatable element allows a variety of different braking mechanisms to be implemented to implement the brake unit.

[0015] In another example, the magnitude of the braking force or braking momentum that can be applied to the rotatable element by the brake unit increases with increasing angular velocity of the rotatable element. Such behavior or response of the brake unit is particularly beneficial because it mimics real or actual forces or reaction forces occurring in the injection device to which the injection simulation device is adapted.

[0016] In the same or another example, the magnitude of the braking force or braking momentum that can be applied to the rotatable element by the brake unit decreases with decreasing angular velocity of the rotatable element. At relatively slow movements of the rotatable element, and therefore at relatively low angular velocities, typically associated with relatively slow injection procedures, reaction forces caused, for example, by the viscosity of the medicament being expelled through the injection needle, are relatively small. Such reaction forces may increase substantially with increasing injection speed and therefore the angular velocity of the rotatable element. Thus, a braking unit providing a velocity-dependent braking momentum and / or a velocity-dependent braking force provides a fairly realistic simulation of the reaction forces occurring in an injection device during a dose injection procedure.

[0017] The braking unit of the infusion simulation device allows the injection simulation procedure to be performed and executed without the need to drain fluid from a drug container, such as a cartridge. Thus, the injection simulation device does not need to be equipped with a dummy cartridge filled with, for example, water for injection or a placebo. Furthermore, because the injection simulation device may be free of a drug container or cartridge, it may not be necessary to replace such a container or cartridge. This replacement process would typically involve disassembly and reassembly of the housing of the injection device.

[0018] Furthermore, because the rotatable element engaged with the brake unit is longitudinally constrained relative to the housing, there is no need to reset the injection simulation mechanism of the injection simulation device, and rather the injection simulation device can be used indefinitely, i.e. repeatedly, without resetting the injection simulation mechanism.

[0019] According to another example, the rotatable element comprises a longitudinal rod. The rotatable element may be implemented as or consist of a longitudinal rod. The rotatable element may represent or replace the piston rod of the drive mechanism of the injection device, except that the rotatable element is longitudinally constrained within and / or relative to the housing of the injection device. The longitudinal rod may be identical in shape to the drive mechanism and / or dose setting mechanism of the injection device, except for the rotatable element or longitudinal rod, and may be mechanically engaged with the dose setting and dose delivery mechanisms of the injection simulation mechanism, which may be configured as such.

[0020] In some examples, the injection simulation device can be derived directly from an actual injection device, such as a pen injector, where only the stopper or piston of the medication container and the piston rod configured to directly abut longitudinally to bias or drive it in the distal ejection direction need to be replaced with a rotatable element, which may lack a specific thread or helical structure that threadably engages with a housing portion, such as a flange or web, of the injection device or injection simulation device housing.

[0021] According to a further example, the rotatable element includes a distal end rotatably supported by a pivot bearing, which may include a rotatable bearing, such as a ball bearing, that can constrain and / or fix the distal end of the rotatable element, and thus the distal end of the longitudinal rod of the rotatable element, with respect to a transverse plane extending perpendicular to the longitudinal direction of the housing.

[0022] A pivot bearing mechanically engaged with the distal end of the rotatable element can hold and / or secure the distal end of the rotatable element in a fairly stable manner within the housing of the injection simulation device. Providing a pivot bearing, and thereby implementing a fairly stable support for the distal end of the rotatable element, is particularly useful for applying a well-defined damping force or damping momentum to the rotatable element.

[0023] For example, a fairly stable rotational support in the form of a pivot bearing at the distal end of the rotatable element allows the brake unit to be located at or near the distal end of the rotatable element. Precise rotatable support at the distal end of the rotatable element may be a prerequisite for precise and reliable braking or slowing of the rotating rotatable element by the brake unit.

[0024] In some examples, the pivot bearing may be integrated into the brake unit. Thus, the distal end of the rotatable element may be rotatably supported by a tapered bearing of the brake unit. In other examples, the pivot bearing may be external to the brake unit, and the brake unit may be disposed in a well-defined position or configuration relative to the pivot bearing. In either case, the brake unit is configured to provide a fairly precise and well-defined braking force or momentum to the rotating rotatable element.

[0025] In another example, the brake unit includes a mount for the distal end of the rotatable element. The mount may be coincident with or incorporated into the pivot bearing. In another example, the mount for the distal end of the rotatable element may be rotatably supported by the pivot bearing. Thus, the pivot bearing may be mounted to or incorporated into the brake unit. The brake unit mount is configured to establish or form a torque-resistant, and therefore torque-transmitting, mechanical connection or coupling with the rotatable element. When the rotatable element is properly attached or connected to the brake unit mount, the rotatable element may be rotatably locked to the mount such that the brake unit mount rotates unitarily with the rotatable element.

[0026] The mount allows rotational motion or movement, and therefore angular momentum, to be transferred from the rotatable element to the mount and therefore to the brake unit, which can then provide a respective braking force or momentum, thereby counteracting and therefore slowing down the rotation of the rotatable element.

[0027] In another example, the mount includes a mechanical coupling structure having a shape complementary to the counter-coupling structure of the rotatable element. The coupling structure may include keying, and the counter-coupling structure may include respective counter-keying that matches the keying. The mechanical coupling structure, and therefore the mechanical coupling of the mount, includes symmetrical damping features having a shape complementary to the symmetrical damping features of the counter-coupling structure of the rotatable element or each of the counter-couplings.

[0028] The opposing coupling structure and the mutually corresponding symmetrical braking features of the coupling structure enable the rotatable element to transfer angular momentum to the mount of the brake unit when subjected to, for example, an induced or controlled rotation by the trigger of the injection simulation device.

[0029] In another example, the brake unit includes a brake element having a radially facing friction surface for frictionally engaging a complementary circumferentially opposing friction surface of the rotatable element. The brake element may include, for example, a type of cantilever or rim braking element that faces radially inward relative to the outer friction surface of the rotatable element. In another example, the radially facing friction surface of the brake element may face radially outward for frictionally engaging a complementary circumferentially, but inwardly facing, opposing friction surface of the hollow rotatable element.

[0030] In any case, the brake unit may be implemented as a friction brake, the brake element may be implemented as a brake shoe, and the brake element may be movably or adjustably arranged within or on the brake unit to compensate for possible mechanical wear of either the friction surfaces or counter-friction surfaces that frictionally engage each other to apply a braking force or momentum to the rotatable element.

[0031] In some examples, the braking element may be biased radially inward or radially outward to apply a well-defined, radially directed contact pressure between the braking element and the rotatable element.

[0032] In another example, the brake unit includes a cylindrical cavity that contains a damping fluid. Here, the brake unit may be implemented as a type of viscous brake unit. The damping fluid may mechanically engage the rotatable element and damp or at least slow down the rotational motion of the rotatable element. The damping fluid may include a relatively high viscosity. At room temperature, the damping fluid may include a viscosity greater than 1 mPA. In some examples, the damping fluid includes a viscosity greater than 2 mPA, greater than 2.5 mPA, greater than 10 mPA, greater than 50 mPA, or greater than 100 mPA.

[0033] The damping fluid may include or contain at least one of the following materials: a paste-like or highly viscous medium, such as water, silicone, silicone oil, glycerin, mineral oil, vegetable oil, etc. In some examples, the damping fluid exhibits temperature-dependent viscosity. The damping fluid may be subjected to significant heating when agitated within the cavity and / or subjected to shear forces. With increasing temperature, the damping fluid may exhibit an increase or decrease in viscosity.

[0034] In a further example, the brake unit includes a brake element immersed in the damping fluid and movable within the cylindrical cavity, thereby agitating the damping fluid or moving relative to the damping fluid, wherein the viscosity of the damping fluid may cause or produce a braking or slowing effect on the movement of the brake element located within the cylindrical cavity and / or immersed in the damping fluid.

[0035] The braking element within the cylindrical cavity may be mechanically connected to and rotatably locked to the rotatable element, for example, via a mount of the brake unit. Thus, the rotatable mount of the brake unit, which mechanically engages or is mechanically engageable with the rotatable element, may be mechanically or rigidly connected to the braking element, which is located within the cylindrical cavity and may be surrounded by damping fluid or may be flushed or cleaned.

[0036] The damping fluid has a slowing, and therefore braking, effect on the movement or rotation of the damping element within the cylindrical cavity. In this way, when the damping element immersed in the damping fluid is rotationally locked to the rotatable element and therefore in torque-transmitting engagement, the damping fluid provides a respective braking force or momentum to the rotatable element via the damping element within the damping fluid.

[0037] In another example, the brake unit includes a shaft rotatable within a unit housing of the brake unit. The unit housing may include or substantially coincide with a cylindrical cavity. One of the shaft and the unit housing is rotatably locked to the rotatable element. The other of the shaft and the unit housing is rotatably locked to a housing of the injection simulation device. The rotatable shaft may be located entirely within the unit housing, and thus within the cylindrical cavity of the brake unit. In some examples, the cylindrical cavity may coincide with or include the unit housing. In other examples, the cylindrical cavity may be part of the unit housing of the brake unit.

[0038] In some examples, a rotatable shaft within the unit housing is in torque-resistant or torque-transmitting engagement with the rotatable element. The rotatable shaft within the unit housing may be mechanically engaged with the rotatable element via a mount of the brake unit. The mount may be rotatably locked to the rotatable shaft at one end and lockable or rotatably locked to the rotatable element at an opposite longitudinal end.

[0039] The shaft may be rotatably supported within the unit housing and / or within the cylindrical cavity by a pivot bearing. In some examples, the distal end of the rotatable shaft of the brake unit is rotatably supported by a pivot bearing, for example, at the bottom of the unit housing. The opposite proximal end of the rotatable shaft may comprise or be fixed to a mount, which is further connected to the rotatable element in a torque-resistant and therefore rotatably locked manner. Here, the pivot bearing, in which the distal end of the rotatable element is rotatably supported within or on the pivot bearing within the housing, is part of or forms part of the brake unit.

[0040] In some examples, the rotatable shaft of the brake unit is or forms a longitudinal extension of the distal end of the rotatable element. With one of the shaft and the unit housing rotatably locked to the rotatable element and the other of the shaft and the unit housing rotatably locked to the housing, a well-defined braking force or braking momentum can be applied or provided between the shaft and the unit housing or cavity of the brake unit to provide a braking force or braking momentum to the rotatable element. Such braking force or braking momentum can be easily and therefore essentially provided by a damping fluid.

[0041] In another example, the brake unit includes at least one of a plate and a blade secured to one of the shaft and the unit housing. The at least one of the blade and the plate is immersed in the damping fluid and extends radially from one of the shaft and the unit housing. When the unit housing is secured to the housing of the injection simulation device, the shaft is rotatably locked or connected to the rotatable element. Thus, the at least one plate or blade is rotatably secured to the shaft and is subjected to rotational movement relative to the unit housing when the rotatable element is subjected to rotation along a first rotational orientation relative to the housing of the injection simulation device.

[0042] The damping fluid is inside the unit housing or cavity and therefore essentially provides a damping, and therefore braking, effect to the shaft and the respective plates or blades in torque-resistant, and therefore torque-transmittable, connection or engagement.

[0043] In another example, it is also conceivable that the unit housing is rotatably locked to the rotatable element. Thus, the shaft of the brake unit is rotatably locked to the housing of the injection simulation device. Typically, one of the shaft and the unit housing that is rotatably locked to the rotatable element typically comprises at least one of a plate and a blade. Thus, during the rotation of the rotatable element relative to the housing, each plate or blade moves within the damping fluid, and this movement is then counteracted and / or slowed by the viscosity and therefore the inherent mechanical friction provided by the damping fluid.

[0044] In another example, the brake unit includes at least a first plate piece and a second plate piece. The first plate piece and the second plate piece are fixed to one of the shaft and the unit housing at a longitudinal distance from each other. The brake unit further includes at least a first opposing plate piece fixed to the other of the shaft and the unit housing. The opposing plate piece is provided or arranged longitudinally between the first plate piece and the second plate piece. Multiple opposing plate pieces may also be provided. The total number of opposing plate pieces may be equal to the total number of plate pieces.

[0045] The brake unit may include a number of alternating plates and counter plates, for example in the shape of disks, which are at least partially or completely immersed in a damping fluid.

[0046] By modifying the longitudinal distance between the first plate piece and the second plate piece and / or modifying the longitudinal gap size between the opposing plate pieces and / or modifying the longitudinal gap size between the plate piece and the opposing plate piece, the braking or deceleration effect can be modified accordingly to suit the requirements of the brake unit.

[0047] In another example, the damping effect, deceleration force, braking force or braking momentum can be varied by selecting an appropriate damping fluid.

[0048] In some examples, the brake unit may include or resemble a viscous coupling or viscous brake. Because the braking force of the braking effect is derived from the viscosity and therefore shear effect of the damping fluid between the moving parts or brake elements of the brake unit, the brake unit may be implemented with significantly less wear, thereby increasing the lifespan of the brake unit and therefore the injection simulation device. The intervals between maintenance of the inspection simulation device and / or the brake unit may also be extended almost indefinitely.

[0049] In another example of an injection simulation device, the brake unit includes a first blade and at least a second blade fixed to one of the shaft and the unit housing. The first blade and the second blade protrude radially and longitudinally from the shaft or the unit housing. Again, because the first blade and the second blade are at least partially or even completely immersed in the damping fluid, movement of the first blade and the second blade caused by rotation of the shaft relative to the unit housing essentially involves stirring and / or shearing the damping fluid, which causes a respective deceleration effect and a respective braking force or braking momentum.

[0050] Again, the number and geometric configuration, eg size and / or shape, of the first blades and / or second blades has a significant impact or influence on the braking force or braking momentum.

[0051] Again, the use of a damping fluid having the appropriate viscosity can provide the desired braking effect or performance of the brake unit. The number of blades fixed to the rotatable shaft can also be varied to provide a desired amount or characteristics of braking effect.

[0052] In another example, at least one of the plates and blades includes at least one of through openings and a lattice structure. The plates may include a disk-shaped flat structure with a through opening extending longitudinally therethrough. The plates may be rotatably supported around a shaft inside the unit housing. The individual plates or plates may extend in a transverse plane, i.e., perpendicular to the extension of the shaft, the shaft forming or including the axis of rotation of the plates.

[0053] The one or more blades extend radially outward from the shaft or radially inward from the sidewall of the cavity or unit housing. The one or more blades may also extend longitudinally. The blades and plates may include one or multiple through-openings, which may further increase the damping or slowing effect when each blade or plate is subjected to motion or movement when immersed in a damping fluid. Again, by varying the geometry, size, density, and / or number of through-openings in the plates and / or blades, the braking force or braking momentum and braking characteristics of the brake unit may be designed or modified accordingly.

[0054] In some examples, the plates or blades may include a type of lattice structure that includes or provides a regular or irregular configuration of through-openings through at least one of the blades and plates. The lattice structure can further modify the damping or deceleration effect. In this way, by selecting an appropriate damping fluid in conjunction with a specific arrangement of the blades and plates relative to each other and / or precisely designing the brake unit by providing through-openings through the plates and / or blades with a specific geometric configuration, density, and size, it is possible to provide a well-defined braking behavior of the brake unit that can accurately mimic or simulate the mechanical reaction forces typically encountered in an injection device during the course of performing an injection procedure.

[0055] The injection simulation device described herein may be broadly adapted to almost any type of injection device, and in particular almost any type of injection pen, provided that each injection pen may include or be equipped with a rotatable element as described herein. The injection simulation device may mimic a fully mechanically implemented injection pen, including a dial extension that is movable proximally in a spiral motion relative to the injection device housing and that is movable distally relative to the housing to inject a dose, where the user may have to provide all of the ejection force required to expel and / or inject the liquid medication.

[0056] In a further example, the injection simulation device mimics the operation of a semi-automated or fully automated injection pen, where at least some or all of the ejection or injection force required to inject the medication is provided in part or in full by an energy store implemented, for example, as a mechanical or electrical energy store.

[0057] According to a further example, the trigger of the injection simulation device is movable from a first position, e.g., a proximal position, to a second position, e.g., a distal position, by manually applying a discharging force to the trigger, and the magnitude of the discharging force required to move the trigger towards and / or to the second position may be governed by or may depend on the braking effect provided by the braking unit.

[0058] Thus, by varying the braking force or momentum applied to the rotatable element, the ejection force required to move the trigger from the first position to the second position can be varied accordingly.

[0059] According to a further example, the distance between the first position and the second position correlates to the degree of rotational displacement of the rotatable element. To that extent, the movement of the trigger may be directly correlated to the rotational movement of the rotatable element. Here, the magnitude of the movement of the trigger, e.g., longitudinal trigger movement, may be directly correlated to the degree or magnitude of the rotational displacement of the rotatable element.

[0060] The greater the distance between the first and second positions of travel of the trigger, the greater the rotational displacement of the rotatable element.

[0061] In some examples, the trigger and rotatable element may be permanently mechanically engaged, for example, via gears or a gear mechanism. In this manner, for example, translational, longitudinal, or helical motion of the trigger relative to the housing may be translated into rotational motion of the rotatable element relative to the housing. The greater the longitudinal movement of the trigger, the greater the rotational motion of the rotatable element during the movement of the trigger.

[0062] If, during operation of the trigger, the force applied to the trigger by the user becomes lower than the ejection force required to move the trigger, the movement of the trigger will stop, with the interruption of the movement of the trigger immediately leading to a respective interruption of the rotational movement of the rotatable element and vice versa.

[0063] In some examples, the rotating element may be infinitely rotatable. The rotating element may not have a stop feature at which the rotational motion can be stopped or interrupted.

[0064] According to a further example, the magnitude of the ejection force required to move the trigger from the first position to the second position depends on the magnitude of the braking force or braking momentum applied to the rotatable element by the brake unit. In this manner, the brake unit provides tactile and / or mechanical feedback to the user to move or depress the trigger. In this manner, the brake unit can mimic the mechanical resistance typically provided by a medicament-filled cartridge when the cartridge stopper is moved distally to expel the medicament from the cartridge.

[0065] In another aspect, the present disclosure relates to a method of simulating an injection of a medication, the method including providing an injection simulation device as described above and performing an injection simulation by actuating a trigger of the injection simulation device.

[0066] Because the method utilizes an injection simulation device as described above, all of the features, effects and advantages described above in relation to the injection simulation device apply equally to the method of simulating an injection, and vice versa.

[0067] In another aspect, the present disclosure also relates to a method of designing, calibrating, or adjusting an injection simulation device, the method comprising the steps of providing an injection device, replacing a piston rod of the injection device with a rotatable element, and longitudinally constraining the rotatable element with respect to or relative to a housing of the injection device.

[0068] The method further comprises the steps of providing a brake unit and mechanically engaging the brake unit with the rotatable element, thus providing for obtaining an injection simulation device from the injection device.

[0069] In a further example, a method for designing, calibrating, or adjusting an injection simulation device includes adjusting or calibrating a brake unit, where the brake unit includes a cylindrical cavity containing a damping fluid, wherein adjusting or calibrating the brake unit includes selecting a damping fluid from a variety of available damping fluids and filling the cylindrical cavity of the brake unit with the selected damping fluid.

[0070] The method of designing, calibrating or adjusting an injection simulation device further includes providing a brake unit including a shaft rotatable within a unit housing, the unit housing including a cylindrical cavity at least partially or completely filled with a damping fluid.

[0071] The method further includes providing the brake unit with at least one of a plate and a blade secured to one of the shaft and the unit housing, and immersing the at least one of the plate and the blade in a damping fluid.

[0072] In another example, to adjust or calibrate the braking behavior of the brake unit, the method includes a step of modifying or selecting the geometric configuration or size of at least one of the plates and blades, and / or a step of modifying some of the plates or blades, and / or a step of modifying at least one of the distance and orientation of at least one of the plates relative to another plate, and / or a step of modifying the distance or orientation of at least one of the blades relative to another blade.

[0073] In a further example, a method for adjusting or calibrating a brake unit of an injection simulation device includes varying at least one of the size, density, or geometric configuration of through openings through at least one of the plates and blades of the brake unit. Modifying at least one of the plates and blades may invariably include selecting each plate or blade from a variety of available plates or blades, the various available plates or blades being distinguished from one another by at least one of the following parameters: size, geometric configuration, relative distance, relative orientation, and number of through openings through the blade or plate; density of through openings in each blade or plate; size and / or geometric configuration of the through openings through each plate or blade.

[0074] In some examples of injection simulation devices, the injection simulation device is obtained directly from an existing injection device. Here, only the piston rod, which may threadably engage with a web or flange of the injection device housing, may need to be replaced with the rotatable element of the injection simulation device. The overall size and shape of the rotatable element may be equivalent to the overall size and shape of the original piston rod of the injection device. Only the distal end of the rotatable element may be rotatably locked or coupled to a brake unit provided as a separate unit from the injection device. When replacing the piston rod of the injection device with the rotatable element, and thus the longitudinal rod, the rotatable element may be distinguished from the original piston rod by the absence of a threaded structure at or near its distal end.

[0075] While the original piston rod of the injection device may be threaded with an internal thread provided on or within the housing of the injection device, in the injection simulation device the rotatable element may simply be rotatably supported by a pivot bearing, which may prevent longitudinal displacement of the piston rod when subjected to rotation, e.g. when a user performs or executes a dose delivery procedure and thus a simulated dose injection.

[0076] In some examples, the injection simulation device includes a dial extension that is movable in the longitudinal proximal direction relative to the housing of the injection device during dose setting. Here, the injection simulation device can simulate not only the injection of a dose, but also the setting of doses of individual or user-selectable sizes. So-called dial extension-type injection simulation devices allow the user to apply a distal ejection force to the dial extension. The dial extension may include, for example, a trigger that must be manually depressed distally by the user's thumb. Depressing the trigger can rotatably lock the drive member or drive sleeve to the housing. The drive member or drive sleeve can be threadedly engaged with a rotatable element, for example, the proximal end of the rotatable element. During the process of ejecting or injecting a dose, the user applies distal pressure to the dial extension, which can cause a purely longitudinal sliding movement of the driver or drive sleeve, which, due to its threaded engagement with the rotatable element, rotates the rotatable element.

[0077] During the dose setting process, a user may rotate the dose dial of the dial extension, which may cause rotation of the drive member. During dose setting, the drive member may be rotatably locked to the housing. The drive member may be permanently locked against rotation along a second rotational direction opposite the first rotational direction. Thus, dialing or rotating motion of the dose dial and / or dial extension may be translated into respective rotational motion of the drive sleeve, which is subjected to a proximally directed helical motion due to its threaded engagement with the stationary rotatable element. In this manner, the dial extension begins to move proximally in a helical manner relative to the housing until the desired size dose is set.

[0078] In general, the scope of the present disclosure is defined by the content of the claims. The transport device is not limited to specific embodiments or examples, but includes any combination of elements from different embodiments or examples. To that extent, the present disclosure covers any combination of claims and any technically feasible combination of features disclosed in relation to different examples or embodiments.

[0079] The terms "drug" or "medicament" are used synonymously herein to refer to a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof and, optionally, a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or medications are used to treat, cure, prevent, or diagnose disease or otherwise improve physical or mental well-being. Drugs or medications may be used for a limited period of time or periodically for chronic conditions.

[0080] As described below, drugs or pharmaceutical agents can include at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs include small molecules having a molecular weight of 500 Da or less, polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0081] Drugs or agents may be contained in primary packaging or "drug containers." Drug containers may be, for example, cartridges, syringes, reservoirs, or other sturdy or flexible vessels configured to provide suitable chambers for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chambers may be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chambers may be designed to store the drug for about one month to about two years. Storage may occur at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, the drug container may be or include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent or two different drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge may be configured to allow mixing of the two or more components prior to and / or during administration to the human or animal body. For example, the two chambers may be configured so that they are in fluid communication with each other (e.g., by a conduit between the two chambers), allowing the user to mix the two components if desired prior to administration. Alternatively, or additionally, the two chambers may be configured to allow mixing upon administration of the components into the human or animal body.

[0082] Drugs or agents contained in drug delivery devices as described herein can be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes mellitus or complications associated with diabetes mellitus, such as diabetic retinopathy, and thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders include acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those listed in handbooks such as the Rote Liste 2014, e.g., but not limited to, Main Group 12 (antidiabetic drugs) or 86 (oncology drugs), and the Merck Index, 15th edition.

[0083] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include insulin, e.g., human insulin or a human insulin analog or derivative; glucagon-like peptide (GLP-1); GLP-1 analog or GLP-1 receptor agonist or analog or derivative thereof; dipeptidyl peptidase-4 (DPP4) inhibitor or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that can be formally derived from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deleting and / or substituting at least one amino acid residue present in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or substituted amino acid residue can be either a codable amino acid residue or another naturally occurring residue, or a purely synthetic amino acid residue. Insulin analogs are also referred to as "insulin receptor ligands." In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from that of a naturally occurring peptide, e.g., the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide may be deleted and / or substituted by other amino acids, including non-codable amino acids, or amino acids, including non-codable amino acids, may be added to the naturally occurring peptide.

[0084] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline in position B28 can be replaced by Asp, Lys, Leu, Val or Ala and in position B29 Lys can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0085] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin. B29-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin, and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0086] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®), Hiramonster (Gila a 39-amino acid peptide produced by the salivary glands of the glandular membrane of the thyroid gland (monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), exendin-4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C (efpegrenatide), HM-15211, CM-3, GLP-1 Erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN -9926, NN-9927, nodexene, Viadol-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (pegapamodtide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, tirzepatide (LY3298176), bamadutide (SAR425899), exenatide-XTEN, and glucagon-Xten.

[0087] An example of an oligonucleotide is, for example, mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic agent for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport syndrome. Examples of DPP4 inhibitors are linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0088] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin, and their antagonists.

[0089] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or ultra-low molecular weight heparin, or derivatives thereof, or sulfated polysaccharides, such as polysulfated forms of the above polysaccharides and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20 (Synvisc®), sodium hyaluronate.

[0090] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain antigen-binding ability. An antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single-chain antibody. In some embodiments, an antibody has effector function and is capable of fixing complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, antibody fragment, or mutant that does not support Fc receptor binding, e.g., with a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable region antibody-like binding proteins with a crossover binding region orientation (CODV).

[0091] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but comprises at least a portion of the full-length antibody polypeptide that is still capable of binding to antigen. Antibody fragments can include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, such as bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, such as bivalent, trivalent, tetravalent, and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0092] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences but are primarily responsible for maintaining the proper orientation of the CDR sequences to enable antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids within the CDRs to interact with the antigen.

[0093] Examples of antibodies are anti-PCSK-9 mAb (e.g., alirocumab), anti-IL-6 mAb (e.g., sarilumab), and anti-IL-4 mAb (e.g., dupilumab).

[0094] Pharmaceutically acceptable salts of any of the APIs described herein are also contemplated for use in the drug or medicament within the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0095] It will be understood by those skilled in the art that modifications (addition and / or deletion) of various components of the APIs, formulations, devices, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the invention, and that the invention encompasses such modifications and any and all equivalents thereof.

[0096] In the following, a number of examples of injection simulation devices are described in more detail with reference to the drawings. [Brief explanation of the drawings]

[0097] [Figure 1] 1 illustrates a schematic diagram of an example of a handheld injection device. [Figure 2] FIG. 1 is a perspective view of a number of components of an injection device. [Figure 3] FIG. 1 is a longitudinal cross-sectional view of an injection device. [Figure 4] 1 shows a schematic longitudinal cross-sectional view of an example of an injection simulation device. [Figure 5] FIG. 10 is a longitudinal cross-sectional view of another example of an injection simulation device. [Figure 6] 1 shows a schematic representation of a braking unit of an injection simulation device and an insert movably positioned therein; [Figure 7] FIG. 7 is a longitudinal cross-sectional view of the braking unit of FIG. 6. [Figure 8] FIG. 8 is a transverse cross-sectional view of the brake unit of FIGS. 6 and 7; [Figure 9] FIG. 8 is another transverse cross-sectional view of the brake unit of FIGS. 6 and 7; [Figure 10] 10 shows another example of a damping unit of an injection simulation device. [Figure 11] FIG. 10 is a longitudinal cross-sectional view of the braking unit of FIG. 9. DETAILED DESCRIPTION OF THE INVENTION

[0098] 1, 2 and 3 show only one of many examples of a handheld injection device 1. The device as shown in FIGS. 1 and 2 is a pre-filled, disposable injection device comprising a housing 10 to which an injection needle 15 can be attached. The injection needle 15 is protected by an inner needle cap 16 and either an outer needle cap 17 or a protective cap 18 configured to surround and protect the distal section of the housing 10 of the injection device 1. The housing 10 may comprise or form a main housing portion configured to house a drive mechanism 8 and / or a dose setting mechanism 9 as shown in FIG. 2. The injection device 1 may further comprise a distal housing component shown as a cartridge holder 14. The cartridge holder 14 may be permanently or detachably connected to the main housing 10. The cartridge holder 14 is typically configured to house a cartridge 6 filled with a liquid medicament. The cartridge 6 comprises a cylindrically or tubularly shaped barrel 25 sealed in the proximal direction 3 by a bung 7 or stopper located within the barrel 25. The bung 7 is displaceable in the distal direction 2 relative to the barrel 25 of the cartridge 6 by means of a piston rod 20. The distal end of the cartridge 6 is sealed by a pierceable seal 26 configured as a septum and pierceable by the proximally directed tip of the injection needle 15. The cartridge holder 14 includes at its distal end a threaded socket 28 for threadably engaging a corresponding threaded portion of the injection needle 15. By attaching the injection needle 15 to the distal end of the cartridge holder 14, the seal 26 of the cartridge 6 is pierced, thereby establishing fluid transfer access to the interior of the cartridge 6.

[0099] When the infusion device 1 is configured to administer, for example, human insulin, the dose set by the dose dial 12 at the proximal end of the infusion device 1 may be displayed in so-called international units (IU, where 1 IU is bioequivalent to approximately 45.5 μg of pure crystalline insulin (1 / 22 mg)). The dose dial 12 may comprise or form a dose dial.

[0100] 1 and 2, the housing 10 includes a dose window 13, which may be in the form of an aperture in the housing 10. The dose window 13 allows the user to view a limited portion of the number sleeve 80, which is configured to move to provide a visual indication of the currently set dose as the dose dial 12 is turned. The dose dial 12 rotates in a helical path relative to the housing 10 when turned during setting and / or when expelling or dispensing a dose.

[0101] The injection device 1 may be configured to provide acoustic feedback to the user by generating a mechanical click sound when the dose knob 12 is turned. The click sound is typically generated by a click noise generator 45. Generally, the click noise generator 45 may be implemented in a variety of different ways. The number sleeve 80 mechanically interacts with a piston in the insulin cartridge 6. When the needle 15 is inserted into the patient's skin and the trigger 11 or injection button is pressed, the dose displayed in the display window 13 is ejected from the injection device 1. When the needle 15 of the injection device 1 remains in the skin for a certain period of time after the trigger 11 is pressed, the dose is actually injected into the patient's body. The ejection of a dose of liquid medication may also generate a mechanical click sound, but this is different from the click sound generated when using the dose dial 12. For this purpose, the injection device 1 may include a separate, therefore second, click noise generator (not shown).

[0102] During delivery of an insulin dose, the dose dial 12 is turned in an axial movement, i.e., without rotation, to its original position, while the number sleeve 80 rotates back to its original position, e.g., to display a dose of zero units.

[0103] The injection device 1 can be used for several injection processes until the cartridge 6 is empty or the expiry date of the drug in the injection device 1 is reached (eg 28 days after first use).

[0104] An example of the drive mechanism 8 is shown in more detail in Figures 2 and 3. The drive mechanism 8 includes a number of mechanically interacting components. The flange-like support of the housing 10 includes a threaded axial through-opening that threadably engages with a first or distal thread 22 of the piston rod 20. The distal end of the piston rod 20 includes a bearing 21 on which a retainer 23 freely rotates about the longitudinal axis of the piston rod 20. The retainer 23 is configured to axially abut against a proximally facing thrust surface of the bung 7 or stopper of the cartridge 6. During an ejection operation, the piston rod 20 rotates relative to the housing 10, thereby performing a distal forward movement relative to the housing 10 and, therefore, relative to the barrel 25 of the cartridge 6. As a result, the bung 7 of the cartridge 6 is displaced in the distal direction 2 by a well-defined distance due to the threaded engagement between the piston rod 20 and the housing 10.

[0105] The piston rod 20 further comprises at its proximal end a second thread 24. The distal thread 22 and the proximal thread 24 are reverse threads.

[0106] A drive sleeve 30 is further provided having a hollow interior for receiving the piston rod 20. The drive sleeve 30 includes internal threads that mate with the proximal threads 24 of the piston rod 20. The drive sleeve 30 further includes an externally threaded section 31 at its distal end. The threaded section 31 is axially confined between a distal flange portion 32 and another flange portion 33 located a predetermined axial distance from the distal flange portion 32. A final dose limiter 35 in the form of a semicircular nut having internal threads that mate with the threaded section 31 of the drive sleeve 30 is provided between the two flange portions 32, 33.

[0107] The final dose limiter 35 further includes a radial recess or protrusion on its outer periphery for engaging a complementary recess or protrusion on the inside of the side wall of the housing 10. In this way, the final dose limiter 35 is splined to the housing 10. Rotating the drive sleeve 30 in the dose increment direction 4, or clockwise, during successive dose setting procedures causes a cumulative axial displacement of the final dose limiter 35 relative to the drive sleeve 30. An annular spring 40 is further provided for axial abutment with a proximally facing surface of the flange portion 33. A tubular-shaped clutch 60 is also provided. At a first end, the clutch 60 comprises a series of circumferentially oriented sawtooth teeth. Towards a second, opposite end of the clutch 60 there is a radially inwardly oriented flange.

[0108] Further provided is a dose dial sleeve, also referred to as a number sleeve 80. The number sleeve 80 is provided outside the spring 40 and the clutch 60 and is located radially inside the housing 10. A spiral groove 81 is provided around the outer surface of the number sleeve 80. The housing 10 is provided with a dose window 13 through which a portion of the outer surface of the number 80 is visible. The housing 10 further comprises a spiral rib on the inner sidewall portion of the insert part 62, which is seated in the spiral groove 81 of the number sleeve 80. The tubular-shaped insert part 62 is inserted into the proximal end of the housing 10. The tubular-shaped insert part 62 is axially fixed so as to be rotatable relative to the housing 10. First and second stops are provided on the housing 10 to limit the dose setting procedure, during which the number sleeve 80 is rotated in a spiral motion relative to the housing 10.

[0109] A dose dial 12 in the form of a dose dial grip is disposed around the outer surface of the proximal end of the number sleeve 80. The outer diameter of the dose dial 12 typically corresponds to and matches the outer diameter of the housing 10. The dose dial 12 is fixed to the number 80 to prevent relative movement therebetween. The dose dial 12 includes a central opening.

[0110] The trigger 11, also referred to as the dose button, is substantially T-shaped. The trigger 11 is provided at the proximal end of the injection device 10. A stem portion 64 of the trigger 11 extends through an opening in the dose dial 12, through the inner diameter of an extension in the drive sleeve 30, and into a receiving recess in the proximal end of the piston rod 20. The stem portion 64 is held for limited axial movement within the drive sleeve 30 and against rotation relative to it. The head of the trigger 11 is generally circular. A trigger sidewall or skirt extends from the periphery of the head and is adapted to be seated in a proximally accessible annular recess in the dose dial 12.

[0111] To dial in a dose, the user rotates the dose dial 12. The drive sleeve 30, spring 40, clutch 60, and number sleeve 80 rotate together with the dose dial 12 due to engagement of the spring 40, which also functions as a click noise generator 45, and the clutch 60. Audible and tactile feedback of the dose being dialed in is provided by the spring 40 and clutch 60. Torque is transmitted via sawtooth between the spring 40 and the clutch 60. The spiral grooves 81 of the number sleeve 80 and the spiral grooves of the drive sleeve 30 have the same lead. This allows the number sleeve 80 to extend from the housing 10 and the drive sleeve 30 to move up the piston rod 20 at the same rate. At the limit of travel, a radial stop on the number sleeve 80 engages either a first stop or a second stop on the housing 10 to prevent further movement in a first rotational direction, e.g., the dose increase direction 4. Rotation of the piston rod 20 is prevented by the opposing directions of the overall and driven threads on the piston rod 20 .

[0112] A final dose limiter 35, which is keyed to the housing 10, advances along the threaded section 31 due to rotation of the drive sleeve 30. Upon reaching the final dose delivery position, a radial stop formed on the surface of the final dose limiter 35 abuts a radial stop on the flange portion 33 of the drive sleeve 30, preventing both the final dose limiter 35 and the drive sleeve 30 from further rotation.

[0113] If the user unintentionally dials in a dose greater than the desired dose, the injection device 1, configured as a pen injector, allows the dose to be dialed lower without expelling any medication from the cartridge 6. To do this, the dose dial 12 is simply rotated backward, causing the system to operate in reverse. The flexible arm of the spring or clicker 40 thus acts as a ratchet, preventing the spring 40 from rotating. Torque transmitted through the clutch 60 causes the sawtooth teeth to overlap each other, producing a clicking sound corresponding to the decrease in the dialed dose. Typically, the sawtooth teeth are arranged so that the circumferential extent of each tooth corresponds to a unit dose. Here, the clutch can function as a ratchet mechanism.

[0114] Alternatively or additionally, the ratchet mechanism 90 may include at least one ratchet feature 91, such as a flexible arm on the sidewall of the tubular-shaped clutch 60. The at least one ratchet feature 91 may include a protrusion extending radially outward, for example, at the free end of the flexible arm. The protrusion is configured to engage with a correspondingly shaped opposing ratchet structure on the inside of the number sleeve 80. The inside of the number sleeve 80 may include a longitudinally shaped groove or protrusion characterized by a sawtooth profile. During dose dialing or setting, the ratchet mechanism 90 enables and supports rotation of the number sleeve 80 relative to the clutch 60 along the second rotational direction 5, which rotation is accompanied by the usual click of the flexible arm of the clutch 60. Angular momentum applied to the number sleeve 80 along the first rotational direction is permanently transferred to the clutch 60. Here, the corresponding ratchet features of the ratchet mechanism 90 provide torque transmission from the number sleeve 80 to the clutch 60 .

[0115] Once the desired dose has been dialed, the user can simply expel the set dose by depressing the trigger 11. This causes the clutch 60 to be displaced axially relative to the number sleeve 80, disengaging its dog teeth. However, the clutch 60 remains rotationally keyed relative to the drive sleeve 30. The number sleeve 80 and dose dial 12 are now free to rotate in accordance with the spiral grooves 81.

[0116] The axial movement causes the flexible arms of spring 40 to deform, ensuring that they cannot overtake the sawtooth during discharge. This prevents drive sleeve 30 from rotating relative to housing 10, but drive sleeve 30 is still free to move axially relative to housing 10. This deformation is then used to urge spring 40 and clutch 60 back along drive sleeve 30, restoring the connection between clutch 60 and number sleeve 80 once distal discharge pressure is removed from trigger 11.

[0117] Longitudinal axial movement of the drive sleeve 30 rotates the piston rod 20 through a through opening in the support of the housing 10, thereby advancing the bung 7 in the cartridge 6. Once the dialed dose has been expelled, the number sleeve 80 is prevented from further rotation by contact between at least one stop extending from the dose dial 12 and at least one corresponding stop on the housing 10. The zero dose position may be determined by abutment of one of the axially extending edges or stops of the number sleeve 80 with at least one or several corresponding stops on the housing 10.

[0118] The ejection or drive mechanism 8 described above is merely illustrative of one of several differently configured drive mechanisms that can typically be implemented in disposable pen injectors. Such drive mechanisms are described in more detail in WO 2004 / 078239 A1, WO 2004 / 078240 A1, or WO 2004 / 078241 A1, which are incorporated herein by reference in their entirety. The injection device 1 includes a dial extension, formed by, for example, the drive sleeve 30, clutch 60, numerals 80, dose dial, and trigger 11, which is subject to reversible longitudinal movement relative to the housing 10 during and / or for setting and injecting a dose. The magnitude of longitudinal displacement of the dial extension may correspond or match the variable size of the dose to be set or injected.

[0119] 4 to 11 show a number of examples of injection simulation devices 100. In principle, the injection simulation device 100 can be derived directly from the injection device 1 as described above in relation to FIGS. 1 to 3. The injection simulation device 100 can include an injection simulation mechanism that is in some way identical in shape or implemented identically compared to the drive mechanism 8 or the dose setting mechanism 9 of the injection device 1 as described above. In fact, and in some examples, the injection simulation device 100 can be distinguished from the injection device 1 only or effectively by the replacement of the piston rod 22 with a rotatable element 120 implemented as a longitudinal rod 121.

[0120] The longitudinal rod 121 may include a threaded portion 124 that threadably mates with a correspondingly shaped threaded section 134 inside the driver 130. The driver 130 may be implemented to be identical or at least functionally similar to the drive sleeve 30 as described in relation to Figures 1 to 3. The driver 130 is typically subjected to a helical movement relative to the housing 110 and thus the rotatable element 120 during dose setting. Dose setting may be guided or controlled by the dose dial 112, which may be mechanically coupled to the driver 130 in a similar or even identical manner as the dose dial 112 is mechanically engaged with the drive sleeve 30 of the injection device 1.

[0121] To that extent, and during or for setting a dose, a user may use the dose dial 112 and rotate it, for example, in the dose increase direction 4, until a dose of the desired size appears in the aperture or window 13. The user may then actuate, for example, a trigger 111 provided at the distal end of the dose dial 112, thereby exerting a distal ejection force on the dial extension and thus the driver 130 in the distal direction 2. By depressing the trigger 111, the mechanical coupling 160 between the trigger 111 and the rotatable element 120 may be switched between a locked state and an unlocked state.

[0122] By depressing the trigger 111, a mechanical coupling 160, implemented, for example, as the clutch 60 of the injection device 1, may be operable to rotationally lock the driver 130 relative to the housing 110 such that the driver 130 is subjected to a non-rotational, longitudinal, distal displacement relative to the housing 110. When a user applies a distal force to the trigger 111, the driver 130 undergoes a non-rotational, distal sliding movement relative to the housing 110, as the threaded engagement between the threaded section 134 of the driver 130 and the threaded portion 124 of the rotatable element 120 results in rotation of each of the rotatable elements along a first rotational direction. Concurrent with the distal sliding movement of the driver 130, any number sleeve 80 of the injection training device 100 may rotate back to its original position or configuration.

[0123] The rotatable element 120 comprises a longitudinally extending rod 121 having a distal end 122. The distal end 122 is rotatably supported by a pivot bearing 126, which in the example of Figure 4 is fastened to the housing 110 via a transversely extending web portion 114 or flange. Via the pivot bearing 126, the rotatable element 120 is longitudinally fixed to the housing 110 and is free to rotate relative to the housing 110 about its longitudinal axis of symmetry.

[0124] The injection training or simulation device 100 further includes a brake unit 140. The brake unit 140 may include a unit housing 141 that encloses a brake element 142, as shown in FIG. 4 . The brake element 142 may include a brake shoe. The brake element includes a friction surface 143 that faces radially inward toward an outer counter friction surface 123 of the longitudinal rod 121. The friction surface 143 frictionally engages the counter friction surface 123, thereby providing a well-defined friction between the brake element 142 and the rotatable element 120.

[0125] A number of braking elements 142 may be provided around the circumference of the rotatable element 120. The braking unit 140 may be located at or near the distal end 122 of the rotatable element 120, where, via the pivot bearing 126, fairly precise guidance and support of the rotatable element 120 may be provided, which is beneficial for providing a well-defined frictional engagement between the non-rotating braking elements 142 and the rotating rotatable element 120.

[0126] 4, the rotatable element 120, and thus the longitudinal rod 121, may extend longitudinally through the brake unit 140, and thus through the unit housing 141. The distal end 122 of the rotatable element 120 may be received in or mechanically engaged with a mount 149 of the pivot bearing 126, thereby providing a fairly precise and well-defined rotational support for the distal end 122 of the rotatable element 120.

[0127] In a further example of FIG. 5, another brake unit 240 is provided. The brake unit 240, also shown in more detail in FIGS. 6-9, includes a unit housing 241, which may be a sealed housing providing a cylindrically shaped sealed cavity 242 filled with a damping fluid 270. The brake unit 240 includes a cylindrically shaped unit housing 241. The unit housing 241 includes a cylindrically shaped side wall 243 that is longitudinally bounded by a top 245 and an opposing flat bottom 244. A longitudinally extending shaft 248 extends within the cavity 242 and is rotatably supported within the cavity 242. Here, a distal end of the shaft 248 is rotatably supported by a pivot bearing 246, which may be fastened to the bottom 244 or located on or integrated into the bottom 244.

[0128] The opposite proximal end of shaft 248 may include a mount 249. Mount 249 may include a mechanical coupling 255 that is complementary in shape to a mechanical counter-coupling 125 provided at distal end 122 of rotatable element 120. Coupling 255 and counter-coupling 125 may be torque-resistant and may include keyed structures or cross-sections, thus breaking symmetry, that allow a rotational coupling to be established between shaft 248 and rotatable element 120 when they are longitudinally overlapped.

[0129] 5-9, distal end 122 of rotatable element 120 is provided with counter coupling 125, which is in torque-resistant engagement with mount 249 and thus with coupling 255 of brake unit 240. As is apparent from FIG. 5, longitudinal shaft 248 of brake unit 240 is implemented as a longitudinal extension of rotatable element 120. Furthermore, shaft 248 is rotatably coupled to and rotatably locked with respect to rotatable element 120.

[0130] The brake unit 240 includes an insert 250 as shown in Figure 6. The insert 250 includes a longitudinally extending shaft 248 and a number of plates 251, 252, 253. Each plate 251, 252, 253 includes a disk and is rotatably fixed to the shaft 248. In that respect, rotation of the shaft 248, caused by rotation of the rotatable element 120, for example in the course of simulating injection of a dose, also results in rotation of each of the plates 251, 252, 253.

[0131] As is further apparent from the cross-sectional views of FIGS. 7-9, the brake unit 240 includes a number of opposing plate pieces 261, 262, 263. As viewed in the longitudinal direction 2, 3, the plate pieces 251, 252, 253 and the opposing plate pieces 261, 262, 263 are arranged alternately, and thus staggered or overlapping with each other. As viewed in the proximal longitudinal direction and starting from the bottom 244 of the brake unit, the first plate piece 251 is followed by the first opposing plate piece 261. The first opposing plate piece 261 is followed by the second plate piece 252. The second plate piece 252 is followed by the second opposing plate piece 262. Proximally following the second opposing plate piece 262 is the third plate piece 253, which is followed by the third opposing plate piece 263.

[0132] The longitudinal gap size between the plate and the opposing plate can be important to the deceleration effect and therefore the magnitude or characteristics of the braking force of the braking momentum provided by the brake unit 240. Rotation of the insert 250 relative to the unit housing 241 is effectively damped by the damping fluid 270 because the cavity 242 surrounding the opposing plate pieces 261, 262, 263 and the plate pieces 251, 252, 253 is filled with damping fluid.

[0133] Plate pieces 251, 252, 253 are fixed to a rotatable shaft 248. Opposing plate pieces 261, 262, 263 are fixed to the inside of a side wall 243 of a unit housing 241. The unit housing 241 is fixed and fastened to the housing 110 of the injection simulation device 100.

[0134] As is particularly apparent from Figure 9, opposing plate piece 263 is connected radially outwardly to the inside of side wall 243 of unit housing 241. Opposing plate piece 263 includes a central through-opening 264 or respective aperture that is slightly larger than the circumference or cross-section of shaft 248. Opposing plate pieces 261, 262, 263 are longitudinally aligned such that each through-opening 264 is longitudinally aligned. In this manner, shaft 248 can pass longitudinally through each through-opening 264.

[0135] Optionally, the disk-shaped plate pieces 251, 252, 253 and the opposing plate pieces 261, 262, 263 each include one or multiple through openings 256, 266. The through openings 256, 266 can influence and modify the damping effect of the damping fluid 270.

[0136] 10 and 11, another brake unit 340 is implemented. In brake unit 340, at least one of the unit housings 341 is substantially identical to unit housing 241 of brake unit 240. Brake unit 340 also includes a cavity 342 enclosed by a cylindrically shaped side wall 343, a flat and circularly shaped bottom 344, and respective tops 345 opposite and separated from bottom 344 and connected to bottom 344 via side wall 343.

[0137] Again, there is provided a longitudinally extending shaft 348 that is rotatably supported by a pivot bearing 346 in the bottom 344 of the unit housing 341. The opposite end of the shaft 348, and therefore the proximal end of the shaft 348, comprises a mount 349 and a respective coupling 355 for providing a torque-resistant, and therefore torque-transmitting, mechanical coupling with the distal end 122 of the rotatable element 120. The brake unit 340, and therefore the unit housing 341, is mechanically fixed to the housing 110 of the injection simulation device 100.

[0138] Instead of several disk-shaped plates and opposing plates as described in connection with the example of Figures 5-9, the brake unit 340 includes multiple blades 351, 352, 353, and 354 fixed to a rotatable shaft 348. As is apparent from the combination of Figures 10 and 11, the blades 351, 352, 353, and 354 extend radially outward at equal angles from the shaft 348. The blades 351, 352, 353, and 354 also include respective extensions in the longitudinal direction, and thus in either the distal direction 2 or the proximal direction 3 as shown in Figure 11. The blades 351, 352, 353, and 354 may have a longitudinal extension slightly less than the longitudinal extent of the cavity 342. Similarly, the blades 351, 352, 353, and 354 may include a radial extent slightly less than half the diameter of the cavity 342. Naturally, the pivot bearing 346 , and therefore the longitudinal shaft 348 , is located radially centrally of the cavity 342 and therefore of the unit housing 341 .

[0139] The first blade 351 may be positioned geometrically opposite the third blade 353. The second blade 352 may be positioned diametrically opposite the fourth blade 354. Thus, the third blade 353 may be a longitudinal or, therefore, radial extension of the first blade 351. The fourth blade 354 may be a radial extension of the second blade 352. The angular arrangement of the multiple blades 351, 352, 353, 354 may provide a fairly uniform force distribution across the cross-section of the tubular-shaped cavity 342. In the example of four blades 351, 352, 353, 354, the angular distance between adjacent blades may be approximately 90°. With only three blades, the angular distance between circumferentially adjacent blades may be approximately 120°. With only two blades, the angular distance between the blades may be approximately 180°. As the number of blades increases, for example six blades, the angular distance between circumferentially adjacent blades can be about 60°.

[0140] The blades 351, 352, 353, 354 are fairly hard and / or rigid, and the blades are also in torque-resistant engagement with the rotatable shaft 348 so that the blades 351, 352, 353, 354 each provide resistance when the blades 351, 352, 353, 354 are subjected to movement or rotation by the rotatable shaft 348 while the blades 351, 352, 353, 354 are at least partially or fully immersed in the damping fluid 270.

[0141] Again, the retarding force, and therefore the braking force or braking momentum, provided by the brake unit 340 may be modified and therefore designed by selecting any suitable damping fluid 270 having a desired viscosity. The geometry, and therefore the size and / or number and relative orientation of the multiple blades 351, 352, 353, 354 may also be modified accordingly.

[0142] Additionally, the blades 351, 352, 353, 354 may be provided with one or multiple through-openings 356, 356'. Similarly, and by modifying at least one of the size, number and geometric configuration of the individual through-openings 356, 356', the retarding force or retarding effect emanating from the blades 351, 352, 353, 354 can be modified to match the predetermined demands of the brake unit 340 and / or to provide the brake unit 340 with required characteristics, e.g., linear or non-linear braking behavior, e.g., with respect to variations in the angular velocity of the rotating element. [Explanation of symbols]

[0143] 1. Injection Device 2 Distal direction 3 Proximal direction 4 Dose escalation 5 Dose decrement direction 6 cartridges 7 Stopper 8 Drive mechanism 9 Dose setting mechanism 10. Housing 11 Triggers 12 Dose Dial 13 Dosage window 14 Cartridge holder 15 Injection needle 16 Inner needle cap 17 Outer needle cap 18 Protective cap 20 Piston rod 21 Bearings 22 First screw 23 Clamp 24 Second screw 25 barrels 26 stickers 28 threaded socket 30 Drive sleeve 31 threaded sections 32 flange 33 flange 35 Final Dose Limiter 40 Spring 45 Click Noise Generator 60 clutch 62 Insert parts 64 Stem 80 Number Sleeve 81 Groove 90 Ratchet mechanism 91 Ratchet feature 100 Injection Simulation Device 110 Housing 111 Trigger 112 Dose Dial 114 Web 120 Rotatable Elements 121 Longitudinal Rod 122 distal end 123 Counter friction surface 124 Threaded part 125 Opposite Coupling 126 Pivot bearing 130 Driver 134 threaded section 140 Brake unit 141 Unit Housing 142 Braking Elements 143 Friction surface 149 Mount 240 Brake Unit 241 Unit Housing 242 Cavity 243 Side wall 244 Bottom 245 Upper 246 Pivot bearing 248 Shaft 249 Mount 250 inserts 251 Plate piece 252 Plate piece 253 Plate piece 255 Coupling 256 Through opening 261 Opposite plate pieces 262 Opposite plate pieces 263 Opposite Plates 264 Through opening 266 Through opening 270 Damping Fluid 340 Brake Unit 341 Unit Housing 342 Cavity 343 Side wall 344 Bottom 345 Upper 346 Pivot Bearing 348 Shaft 349 Mount 350 insert 351 Blade 352 Blade 353 Blade 354 Blade 355 Coupling 356 Through opening

Claims

1. An injection simulation device (100) operable to simulate the injection of a dose of a drug, comprising: a housing (110) defining a longitudinal direction (2, 3); a rotatable element (120) arranged inside said housing (110), said rotatable element (120) being rotatable relative to said housing (110) and being constrained by said housing (110) in said longitudinal direction (2, 3); a trigger (111) manually operable by a user to initiate or control said simulated injection of said dose; a mechanical coupling (160) mechanically engaged with said trigger (111) and said rotatable element (120), said mechanical coupling (160) operable to induce or translate actuation of said trigger (111) into a rotation of said rotatable element (120) along a first rotational orientation relative to said housing (110); a brake unit (140; 240; 340) fixed to said housing (110) and in torque-resistant engagement with said rotatable element (120), said brake unit (140; 240; 340) operable to apply a braking force or momentum to said rotatable element (120); An injection simulation device (100) comprising:

2. 2. The injection simulation device of claim 1, wherein the brake unit is operable to apply a variable magnitude of braking force or braking momentum to the rotatable element, the magnitude of the braking force or braking momentum varying with the angular velocity of the rotatable element relative to the housing.

3. 3. The injection simulation device (100) of claim 2, wherein the magnitude of the braking force or braking momentum that can be applied to the rotatable element (120) by the brake unit (140; 240; 340) increases with increasing angular velocity.

4. The injection simulation device (100) of any one of claims 1 to 3, wherein the rotatable element (120) comprises a longitudinal rod (121).

5. The injection simulation device (100) of any one of claims 1 to 4, wherein the rotatable element (120) comprises a distal end (122) rotatably supported by a pivot bearing (126).

6. The injection simulation device (100) according to any one of claims 1 to 5, wherein the brake unit (140; 240; 340) comprises a mount (149; 249; 349) for the distal end (122) of the rotatable element (120).

7. 7. The injection simulation device (100) of claim 6, wherein the mount (149; 249; 349) includes a mechanical coupling structure (255; 355) that is complementary in shape to an opposing coupling structure (125) of the rotatable element (120).

8. 8. The injection simulation device (100) of claim 1, wherein the brake unit (140) comprises a brake element (142) having a radially facing friction surface (143) for frictionally engaging a complementary shaped circumferentially opposing friction surface (123) of the rotatable element (120).

9. The injection simulation device (100) according to any one of the preceding claims, wherein the brake unit (140) comprises a cylindrical cavity (242; 342) containing a damping fluid (270).

10. 10. The injection simulation device (100) of claim 9, wherein the brake unit (240; 340) comprises a shaft (248; ​​348) rotatable inside a unit housing (341; 351), the unit housing (341; 351) enclosing the cylindrical cavity (242, 342), one of the shaft (248; ​​348) and the unit housing (341; 351) being rotatably locked to the rotatable element (120), and the other of the shaft (248; ​​348) and the unit housing (341; 351) being rotatably locked to the housing (110).

11. The injection simulation device (100) of claim 10, wherein the brake unit (240; 340) is fixed to one of the shaft (248; ​​348) and the unit housing (341; 351), is immersed in the damping fluid (270), and includes at least one of a plate (251, 252, 253) and a blade (351, 352, 353) extending radially from one of the shaft (248; ​​348) and the unit housing (241; 341).

12. 12. The injection simulation device (100) of claim 11, wherein the brake unit (240) includes at least a first plate piece (251) and a second plate piece (252), the first plate piece (251) and the second plate piece (253) being fixed to one of the shaft (248) and the unit housing (241) at a longitudinal distance from each other, and the brake unit (240) further includes at least a first opposing plate piece (261) being fixed to the other of the shaft (248) and the unit housing (241) in the longitudinal direction between the first plate piece (251) and the second plate piece (253).

13. 13. The injection simulation device (100) of claim 11 or 12, wherein the brake unit (240) includes a first blade (351) and at least a second blade (252) fixed to one of the shaft (348) and the unit housing (341) and protruding from the shaft (348) or the unit housing (341) at equal angles in the radial direction (r) and the longitudinal direction (2, 3).

14. The injection simulation device (100) according to any one of claims 11 to 13, wherein at least one of the plates (251, 252, 253) and the blades (351, 352, 353) comprises at least one of through openings (356) and a lattice structure.

15. The injection simulation device (100) of any one of claims 1 to 14, wherein the rotatable element (120) is longitudinally locked to the housing (110).

16. 16. The injection simulation device (100) of claim 1, wherein the trigger (111) is movable from a first position to a second position by manually applying an ejection force to the trigger (111), the distance between the first position and the second position correlating with the degree of rotational displacement of the rotatable element (120).

17. 17. The injection simulation device (100) of claim 16, wherein the magnitude of the ejection force required to move the trigger (111) from the first position to the second position depends on the magnitude of the braking force or braking momentum applied to the rotatable element (120) by the brake unit (140; 240; 340).

18. 1. A method of simulating the injection of a dose of a drug, comprising: - providing an injection simulation device (100) according to any one of claims 1 to 17; - performing an injection simulation by actuating the trigger (111) of the injection simulation device (100); A method comprising:

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