RU2793643C2 - Injection device and recorder - Google Patents

Abstract

FIELD: medical technology.

SUBSTANCE: injection device comprises: an elongated body (10) defining a longitudinal direction (z) and configured to receive a cartridge (20) containing a drug; a recording device (50) adapted to register the relative movement between the first element (100) and the second element (200), wherein the first element (100) undergoes a first movement relative to the second element (200) along the first longitudinal direction (3) to set the dose, and moreover, the first element (100) undergoes a second movement relative to the second element (200) along the second longitudinal direction (2) for dispensing a dose, and wherein one of the first movement and the second movement is a helical movement, and the other of the first movement and the second movement represents a sliding movement in the longitudinal direction (z); moreover, the second element (200) contains at least one orientation element (60; 160)attached to the second element (200); moreover, the first element (100) contains a surface (102) of a tubular shape, equipped with a relief (104) facing the reference element (60; 160); moreover, the recording device (50; 150) contains at least one electrical sensor (51; 151) located on one of the first element (100) and the second element (200) and adapted to register changes in the position of the relief (104) relative to at least one orientation element (60; 160) and for generating at least one electrical signal in response to a change in the position of the relief (104) during at least one of the first movement and the second movement of the first element (100) relative to the second element (200).

EFFECT: invention relates to an injection device for setting and administering pre-set or user-selectable doses of a drug.

15 cl, 43 dwg

Description

The technical field to which the invention belongs

The present invention relates in one aspect to an injection device, such as a pen, for delivering pre-set or user-selectable doses of a drug. In particular, the present invention relates to an injection device comprising a recording device adapted to record or quantify the amount of dose actually administered or delivered by the injection device.

Background of the invention

Injection devices for inserting and dispensing one or more doses of a liquid drug are well known in the art as such. In general, such devices serve essentially the same purpose as a conventional syringe.

Injection devices, in particular pens, must meet a number of requirements specific to the user. For example, in case the patient suffers from a chronic disease such as diabetes, the patient may be physically weak and may also have impaired vision. Appropriate injectable devices are specifically designed for home treatment, so they must be robust and easy to use. In addition, manipulation and general handling of the device and its components must be intelligible and understandable. Moreover, the setting of the dose as well as the procedure for issuing the dose should be simple to perform and unambiguous.

Typically, such devices comprise a housing containing a specific cartridge holder adapted to receive a cartridge at least partially filled with a drug to be dispensed. Such devices further comprise a transmission or release mechanism, typically having a displaceable piston rod that is adapted to operably engage with the cartridge piston. The transmission mechanism and the piston rod are adapted to bias the cartridge piston in the distal or dispensing direction and thus can release a predetermined amount of drug through the piercing assembly, which must be detachably connected to the distal end section of the injection device body.

The drug to be dispensed by the injection device is typically provided and contained in a multi-dose cartridge. Such cartridges typically comprise a glass capsule sealed distally by a pierceable seal and further sealed proximally by a plunger. In the case of reusable injection devices, the empty cartridge is replaced with a new one. In contrast, single-use injection devices should be discarded after the drug in the cartridge has been dispensed or used up.

Some injection devices are operated mechanically and/or manually. In this case, the user must set the dose by manually operating the dose dial element, for example, by rotating or sliding the dose dial element relative to the body of the injection device. To dispense or release a dose, the user must move the dial element and/or trigger element in the opposite direction. There are pen type injection devices, such as those disclosed in WO 2004/078239 A1, WO 2004/078240 A1 or WO 2004/078241 A1, comprising a dial cap which is subjected to a combined rotational and longitudinal displacement in the proximal direction for dose setting and further subjected to sliding displacement in the opposite longitudinal direction, i.e., the distal direction for dispensing or dispensing a dose of drug. In manually operated injection devices, the user must apply an actuating force to a trigger element, such as implemented as a dose button or a trigger button. The transmission mechanism is typically adapted to convert a user-applied transmission force into a distally directed transmission movement of a piston rod that is in operative engagement with the plunger or plug of the drug-filled cartridge.

A set nozzle, for example, an assembly of several components of an injection device that can be displaced relative to the housing at least for the purpose of setting a dose, typically contains a dose set element that is rotatable relative to the dose setting housing. The dial nozzle may further comprise a dose button or trigger button that can be pressed in the distal longitudinal direction of the body to initiate and/or control the delivery or release of a dose.

To monitor the use of an injection device, for example, to monitor patient compliance with a prescribed drug regimen, such injection devices may be equipped with a recording device adapted to record at least one of the time when an injection occurs and the amount of dose administered or released by the injection device. To determine or quantify the dose value, at least one of the rotational and longitudinal displacement of at least one component of the injection device relative to another component of the injection device must be recorded and/or measured.

The implementation and integration of an electronic recording device into a manually operated and/or mechanically implemented injection device is quite a challenge, especially when an existing injection device must be upgraded by installing an electronic recording device on it.

Thus, it is desirable to provide an injection device with an improved recording device that can be easily used with and incorporated into a wide variety of different injection devices. Implementation of the recording device should be fairly simple and should be limited to minor modifications to only one or a couple of components of the injection device. Moreover, the recording device must be realized in a sufficiently economical manner and must require only a minimum of additional installation space.

Brief description of the invention

In one aspect, the present invention relates to an injection device for setting and administering pre-set or user-selectable doses of a drug. The injection device contains an elongated body that defines the longitudinal direction. The elongated body is configured to receive the cartridge. The cartridge contains a drug. The injection device further comprises a recording device that is adapted to register relative movement between the first element and the second element of the injection device. The first element undergoes a first movement relative to the second element along the first longitudinal direction to set the dose. The first element is subjected to a second movement relative to the second element along the second longitudinal direction to deliver the dose. In this case, one of the first movement and the second movement is a helical movement, i.e. the first element is subject to a combined longitudinal and rotational movement relative to the second element. The other of the first movement and the second movement is a sliding movement in the longitudinal direction. The sliding movement is a longitudinal sliding movement, wherein the first element is rotatably attached to the second element. In this case, the sliding movement is not accompanied by rotation.

Typically, the first longitudinal direction is opposite to the second longitudinal direction. Moreover, the longitudinal component of the first movement is opposite to the longitudinal component of the second movement.

The second element contains at least one landmark element. The orienting element may be a special part of the second element. It can define a positional reference for the first element. The reference element is attached to the second element. Therefore, the reference element is fixed relative to the second element. It can be permanently attached to the second element.

The first element of the injection device contains a tubular surface, which is provided with a relief. The relief faces at least one orienting element. The relief may be provided on the surface of the tubular mold. It may be attached to the surface of the tubular mold or may be embedded in the surface of the tubular mold. The relief is a spatial relief. It may contain a spatial code and may be intended to encode the first element.

The injection device further comprises a recording device. The recording device contains at least one electrical sensor. The electrical sensor is adapted to register changes in the position of the relief relative to the reference element. The electrical sensor is further adapted to generate at least one electrical signal, typically a sequence of electrical signals, in response to a change in position of the relief relative to the at least one reference element. Therefore, at least one electrical sensor is adapted to generate electrical signals during and in response to at least one of the first movement and the second movement of the first element relative to the second element.

At least one electrical sensor is located on one of the first element and the second element. At least one electrical sensor is adapted or configured to interact directly with at least one of the relief and landmark element. In some examples, at least one electrical sensor is adapted to detect and/or determine the direct interaction between the terrain and the landmark. In particular, at least one electrical sensor is adapted to detect and/or to determine the degree of rotation of the first element relative to the second element when the first element is subjected to a helical movement relative to the second element. Moreover, at least one electrical sensor can be configured to detect only longitudinal sliding displacement without rotation of the first element relative to the second element.

In some examples, at least one electrical sensor and a corresponding recording device can be made or can be adapted to detect and/or measure the longitudinal displacement as well as the rotational displacement of the first element relative to the second element. In some examples, the recording device and at least one electrical sensor may be adapted to detect and/or quantify rotational displacement and/or longitudinal displacement between the first element and the second element when the first element is subjected to helical motion relative to the second element.

The recording device and at least one electrical sensor can be configured to measure the rotational displacement and the longitudinal displacement simultaneously. Thus, the registration and measurement accuracy can be increased and the registration and/or measurement error rate can be reduced.

In an additional example, at least one electrical sensor is located on the first element or on the second element. When the electrical sensor is located on the second element, it may coincide with the reference element, or it may be a landmark element. When an electrical sensor is located on the first element, at least one electrical sensor is generally electrically connected to the relief of the first element. Then, in order to register and/or measure the relative displacement of the first element relative to the second element, the relief directly interacts with the landmark element of the second element when the first and second elements undergo at least one of the first movement and the second movement.

By arranging at least one electrical sensor and potentially even the entire recording device on the first element, a fairly simple, straightforward and uniform incorporation or incorporation of the reference element into or onto the second element is provided and maintained. In this case, the reference element may be a passive electronic device or a passive electronic structure such as a bridge contact.

In another example, the first movement of the first element relative to the second element is a helical movement. The second movement is a longitudinal sliding movement of the first element relative to the second element, during which the first element cannot rotate relative to the second element.

In some examples of the injection device, the longitudinal displacement of the first element relative to the second element during the first movement is equal in magnitude to the longitudinal displacement of the first element relative to the second element during the second movement.

As a rule, the longitudinal component of the first movement is opposite to the longitudinal component of the second movement. If the first element is moved in the longitudinal proximal direction during the first movement, it will move in the opposite longitudinal direction, i.e. distally, during the second movement.

Typically, the longitudinal position of the first element relative to the second element before dose setting is the same as the longitudinal position of the first element relative to the second element after completion of the dose delivery or dose release procedure.

The rotational position and therefore the rotational state of the first element relative to the second element before the dose is set may be different from the rotational state or rotational orientation of the first element relative to the second element after completion of the dose delivery or dose release procedure. This is especially true in situations where the helical movement of the first element relative to the second element involves only a fraction of a turn, or a non-integer multiple of a full turn of the first element relative to the second element.

In some examples, the recording device and at least one electrical sensor are adapted to detect and/or quantify at least one of the first movement and the second movement, regardless of the initial rotational state or rotational orientation of the first element relative to the second element. The registration of movement can be started and can be ended in any possible and therefore arbitrary rotational position or rotational orientation of the first element relative to the second element.

In some examples, both the first element and the second element are tubular in shape. They can be either in direct or indirect mechanical engagement to make a relative helical movement in one longitudinal direction and to make a relative sliding displacement without rotation along the other longitudinal direction. The first element and the second element can be arranged such that one of them is nested within the other. One of the first and second elements may at least partially circumferentially or radially surround another of the first and second elements.

In some examples, the first element is subjected to a helical movement along the longitudinal proximal direction relative to the second element for setting the dose. Then the first element is subjected to sliding displacement without rotation relative to the second element along the distal longitudinal direction during the delivery of the dose. In other examples, to set the dose, the first element cannot be rotated, but can be displaced in the axial direction relative to the second element, usually along the longitudinal proximal direction. To deliver or release a dose, the second element may be subjected to a helical movement relative to the second element in a distal direction.

In another example, the relief comprises at least a first relief portion and a second relief portion. The first and second parts of the relief are spatially non-overlapping parts of the relief. Therefore, the second relief part does not overlap with the first relief part. On the surface of the tubular form of the first element, the first part of the relief and the second part of the relief are located next to each other or close to each other. Thus, the first and second parts of the relief form a spatial relief, which allows to evaluate and/or quantify at least one of the rotational and longitudinal movement of the relief relative to the landmark.

At least one electrical sensor can distinguish the first part of the relief from the second part of the relief. Each time one of the first and second portions of the terrain passes at least one electrical sensor, the at least one electrical sensor is adapted to generate a processable electrical signal that indicates that the terrain is currently undergoing movement relative to the reference element.

In another example, the first relief part and the second relief part differ in at least one of the following parameters: electrical conductivity, optical transparency, optical reflectivity, magnetic susceptibility, or electrical susceptibility. The first and second parts of the relief may further differ in their radial position relative to the central axis of the surface of the tubular shape. For example, the first and second reliefs may be formed by protrusions or depressions, such as ridges or grooves, on the surface of the tubular shape of the first element.

At least one electrical sensor is implemented in accordance with the distinctive parameters of the first relief part and the second relief part. If the first and second relief portions differ in their electrical conductivity, at least one electrical sensor can typically measure the electrical conductivity of the relief and its respective first and second relief portions. The at least one electrical sensor may comprise at least one electrical contact terminal which is configured and adapted to come into electrical contact with only one of the first relief part and the second relief part at a time. Similarly, when the first and second relief portions differ in optical transparency or optical reflectivity, the at least one electrical sensor typically includes at least one of a light source and a photosensor. Typically, the recording device and at least one electrical sensor comprise a combination of a light source and a photosensor, such as a light emitting diode (LED) and a photodiode.

Accordingly, when the first and second relief portions differ in their magnetic susceptibility or electrical susceptibility, at least one electrical sensor comprises a corresponding array of magnetic or dielectric sensors capable of distinguishing the first relief portion from the second relief portion representing the relief of the first element, wherein the first and second parts of the relief have different magnetizations.

When the first relief part and the second relief part have different radial positions relative to the central axis of the tubular surface, at least one electrical sensor can be implemented as a mechanical or electromechanical switch located at a predetermined radial distance from the central axis. In this case, the first and second parts of the relief may differ in their radial height. For example, the first embossing portion may comprise a recess or groove in the surface of the tubular shape, and the second embossing portion may include at least one of a protrusion, rib, or ridge extending radially from the tubular shape surface of the first element. When at least one of the protrusion or recess passes at least one electrical sensor, the corresponding electromechanically implemented switch can be activated or deactivated, thereby resulting in the generation of a corresponding electrical signal, which can be processed to detect movement and/or to quantify measuring the amount of at least one of the first movement and the second movement between the first and second elements.

According to another example, the longitudinal extent of the relief is equal to or greater than the maximum longitudinal displacement of the first element relative to the second element. In this way it is ensured that the first relief is and remains within the defined zone of the orienting element, even if the first element is subjected to a maximum longitudinal displacement relative to the second element. When the orienting element is equipped with at least one electrical sensor, the relief and the sensor cannot get out of contact or out of interaction, even if the first element is subjected to the maximum possible longitudinal movement relative to the second element. Thus, for each allowable longitudinal position of the first element with respect to the second element, at least one of the recording device, at least one electrical sensor and the reference element is and remains in direct interaction with the relief of the first element.

According to another example, the relief comprises a first relief section and a second relief section. The first relief section and the second relief section are arranged without overlap on the surface of the tubular mold. The second relief section is separated from the first relief section in the longitudinal direction. In other words, the first relief section may comprise or form a first longitudinal relief section, and the second relief section may comprise or form a second longitudinal relief section that does not overlap with the first longitudinal relief section.

At least one of the first and second relief sections comprises a first relief part and a second relief part, as described above. Even both the first and second relief sections may each comprise at least a first relief portion and at least a second relief portion.

For example, the first section of the relief may contain the first partial relief. The second relief section may comprise a second partial relief. The first and second partial reliefs may be substantially the same. The first and second sections of the relief can differ significantly. The first and second relief sections are generally separated from each other in the longitudinal direction on the surface of the tubular shape of the first element.

The first and second sections of the relief may be designed for different purposes of registration. The first relief section may have a longitudinal extension that is greater than the longitudinal extension of the second relief section. Moreover, the second relief section may be provided or located at the axial end of the first relief section. The second section of the relief may be covered or surrounded by the first section of the relief. In some examples, the first section of the relief is made and adapted to register and/or measure the rotational movement of the first element relative to the second element. The second relief section may be configured to register and/or measure the longitudinal movement and therefore movement without rotating the first element relative to the second element.

At least one electrical sensor may be provided for interacting with at least one of the first relief section and the second relief section. At least two electrical sensors may be provided, one of which is designed and adapted to interact exclusively with the first section of the relief, and the other of which is implemented and exclusively configured to interact only with the second section of the relief.

Typically, the transition from the first relief section to the second relief section along the longitudinal direction can be detected by at least one electrical sensor. Thus, the interaction between the at least one electrical sensor and the first and second relief sections can be designed to record the specific longitudinal position of the first element relative to the second element, for example, when the first element returns to its original or end-of-dose configuration relative to the second element at the end of the procedure. dispensing a dose or releasing a dose.

In another example, the first section of the relief contains a striped relief containing several parallel oriented longitudinal strips. The longitudinal strips run parallel to the longitudinal direction. Therefore, they can extend parallel to the central axis of the surface of the tubular shape of the first element. In another example, the longitudinal strips extend at a predetermined non-zero angle with respect to the longitudinal direction.

In a striped pattern comprising a number of parallel oriented longitudinal strips extending parallel to the longitudinal direction, the first section of the pattern is specifically defined and configured to determine and/or measure the rotational movement of the first element relative to the second element. If the longitudinal strips extend at a predetermined angle relative to the longitudinal direction, in other words, if the longitudinal strips of the first section of the relief are oblique or inclined with respect to the central axis, not only the rotational displacement of the relief can be detected and quantified by means of at least one electrical sensor and, therefore, of the first element relative to the second element, but the longitudinal sliding movement without rotation of the first element relative to the second element can also be registered and quantified, for example, using only the same electrical sensor.

A striped relief may contain several stripes of the same or different geometric shapes. The strips may be spaced at the same angle around the circumference of the surface of the tubular shape. According to the angular coding, the striped relief stripes can also be unevenly distributed in the tangential direction on the surface of the tubular shape. Striped relief stripes can also have different sizes.

The position, size, shape, and orientation of the striped relief stripes are highly dependent on the specifically implemented coding scheme. It depends on the number and position of the at least one electrical sensor. In some examples, the number, size, geometry, and orientation of the strips depend on the number, size, and position or orientation of the bridge contacts provided on the second element.

According to a further example, the recording device is adapted to register the longitudinal overlap of the orientation element with at least one of the first relief section and the second relief section, regardless of the rotational state of the first element relative to the second element. Longitudinal overlap means that the reference element and at least one of the first relief section and the second relief section are located in the same longitudinal position. In this case, the landmark element and at least one of the first relief section and the second relief section may overlap in the radial direction with respect to the tubular relief shape.

In particular, the recording device and/or at least one electrical sensor is adapted to detect the transition from the first relief section to the second relief section and vice versa. In other words, the recording device is configured to detect the moment when the first section of the relief, initially overlapping in the radial direction with the reference element, undergoes a longitudinal displacement, as a result of which the second section of the relief begins to overlap in the radial direction with the reference element. The separation or transition between the first and second relief sections may be recorded by a recording device. Thus, the longitudinal or axial end position of the first element relative to the second element can be accurately recorded, which indicates to the recording device that, for example, the dose release procedure has been completed and that the injection device is in the initial state, in which it is ready for the subsequent dose setting procedure. and dose administration.

As a rule, the recording device is adapted and configured to register a longitudinal sliding displacement of at least one of the first relief section and the second relief section relative to the reference element, regardless of the rotational state or rotational orientation of the first element relative to the second element. In fact, at any pivotal position of the first element relative to the second element, at least a longitudinal displacement or movement of the first element relative to the second element can be registered. To achieve such registration, the second relief section may comprise a relief or partial relief that differs in size and/or geometric shape from the relief or partial relief of the first relief section. For example, the second section of the relief may have an annular shape, allowing to register the longitudinal sliding movement or helical movement of the first element relative to the second element for any available rotational state or rotational orientation of the first element relative to the second element.

In an additional example, the relief contains at least a first part of the relief, which is electrically conductive. The relief contains at least the second part of the relief, which is electrically insulating. As a rule, the relief contains several first parts of the relief and several second parts of the relief. For example, a relief contains a series of electrically conductive parts and a series of electrically insulating parts. The electrically conductive relief parts can be electrically separated or galvanically isolated from each other by means of electrically insulating second relief parts.

The first relief part and the second relief part, being electrically conductive and electrically insulating, respectively, can correspond to and represent the aforementioned first and second relief parts, which are arranged without overlapping each other and which differ in their electrical conductivity.

The first and second parts of the relief may be arranged in alternation along at least one of the first movement and the second movement between the first and second elements. The first and second parts of the relief can be separated from each other along the circumference or along the direction along the tangent surface of the tubular shape of the first element. The first and second relief parts can also be separated along the longitudinal direction of the surface of the tubular shape. The first and second parts of the pattern may comprise a striped pattern with an alternating pattern of stripes having at least two different electrical conductivities. The relief is not limited to the first relief section and the second relief section. Several different relief sections may be provided, for example a first, second, third or even more relief sections, all of which differ from each other, for example, in their electrical conductivity. Thus, a higher information density or code density can be provided on the surface of the tubular shape.

In some examples, relief is provided on the outer surface of the first element. In other examples, relief is provided on the inner surface of the first element.

The relief may be a binary relief containing information content provided by at least two, namely the first and second parts of the relief, which represents the number 0 or the number 1, respectively.

The relief and at least one electrical encoder can be implemented as an incremental encoder or as an absolute encoder. They can be implemented as a 2-bit Gray code. Depending on the number of electrical sensors or electrical contact leads, and depending on the specific implementation of the relief, other codes may also be provided, providing for 3-bit coding or n-bit coding, where n is an integer.

When the pattern contains an electrically conductive structure, for example when the first part of the pattern is electrically conductive, it may comprise one of a conductive glossy coating, a conductive varnish, a conductive coating, or a conductive etch. The conductive gloss coating or conductive lacquer may contain electrically conductive particles, such as metal particles or carbon black particles. The electrically conductive pattern may also include a metal insert in or on the surface of the tubular shape of the first element. The first element may comprise a thermoplastic material that is substantially electrically insulating. Thus, only the electrically conductive parts of the relief need be provided on the electrically insulating material of the first element. The electrically conductive first relief portion may also comprise sheet metal attached to or included in and flush with the surface of the tubular shape of the first element. At least the first electrically conductive part of the pattern can be attached to or installed on the surface of the tubular mold by injection molding with an insert or by two-component injection molding of the first element.

In a further example, the recording device comprises at least one electrical contact lead disposed on the second element and adapted to alternately connect with the first pattern part and the second pattern part when the first element undergoes one of a first movement and a second movement relative to the second element. The electrical contact terminal may be radially displaced so as to engage in frictional engagement with the relief of the first element. When the relief is provided on the outer surface of the tubular shape of the first element, at least one electrical contact terminal is displaced radially inward. It is flexible and can be deformed radially outward by the relief against the action of an internal restoring force.

When the surface of the tubular shape is an inner surface, at least one electrical contact terminal is displaced radially outward and may be deformed or bent radially inward against an appropriate restoring force. An electrical contact terminal may represent a reference element. Therefore, the orienting element may comprise at least one terminal for electrical contact. The orienting member may comprise a plurality of electrical contact leads arranged and distributed along the outer or inner circumference of the tubular shape surface.

In another example, the pattern comprises at least a third pattern portion which is electrically conductive, the first pattern portion and the third pattern portion being electrically separated from each other. Therefore, the first part of the relief and the third part of the relief are galvanically isolated from each other. The first relief part and the third relief part can be electrically separated by the second relief part, which is electrically insulating. By providing at least two different types of electrically conductive relief portions, an implementation of an n-bit encoder of the rotation angle is provided and supported, where n is an integer equal to or greater than 2. When the first relief portion and the third relief portion are electrically distinguishable, they can be individually and/or separately electrically connected to the recording device when they are subjected to one of the first and second movement, thus providing, for example, a 3-bit rotary encoder.

In other examples, the third part of the pattern may be permanently electrically connected to the voltage source of the recording device. In this case, at least one electrical sensor may be electrically connected to the first part of the relief. The encoder of the angle of rotation can be realized by a bridge contact provided on the second element. The bridge contact may be configured and adapted to selectively establish an electrical connection between the third pattern part and the first pattern part when the first element is subjected to helical or rotary movement relative to the second element. In this example, the second element may not contain any active electronic components. It may contain only passive electrically conductive components, such as terminals for an electrical contact or at least one bridge contact.

In another example, a recording device and at least one electrical sensor are located on the first element. At least one electrical sensor is electrically connected to the first part of the relief. At least one reference element is located on the second element and contains an electrical bridge contact. The electrical bridge contact is configured to alternately establish and break electrical contact between the first relief part and the third relief part when the first element undergoes one of the first movement and the second movement relative to the second element.

Typically, the electrical bridge extends in a tangential direction relative to the tubular shape of the first element. A bridge contact can be implemented and adapted to establish electrical contact between the first relief part and the third relief part, for example, thereby connecting the second relief part located between the first relief part and the third relief part and/or separating them. This electrical connection between the first relief part and the third relief part is generally provided when the first element is in a first rotational position or rotational orientation with respect to the second element. When the second element undergoes further rotation and assumes a second rotational state or rotational orientation, at least one of the first relief part and the third relief part loses contact with the electrical bridge contact. Thus, the first part of the relief and the third part of the relief become electrically or galvanically isolated.

Since at least one electrical sensor is electrically connected to the first relief part, alternating electrical contact with the third relief part can be detected by at least one electrical sensor when the first element is rotated relative to the second element. In this case, the third part of the relief can also be electrically connected to at least one electrical sensor or to another electrical sensor of the recording device. Alternatively, the third part of the relief may be permanently connected to the voltage source of the recording device. In the rotational positions of the first and second elements, in which the first part of the relief is electrically connected to the third part of the relief by means of at least one electrical bridge contact, a supply voltage is applied to the first element. In other rotational states, in which the first part of the pattern is electrically separated from the third part of the pattern, an electrical sensor connected to the first part of the pattern will register zero voltage.

The use and implementation of at least one electrical bridge contact is advantageous, since the second element can be easily adapted to the implementation and implementation of the recording device. In this case, it is only necessary to change the geometry of the second element slightly in order to accommodate or accommodate at least one electrical bridge contact. In this case, the second element does not require any active electrical or electronic components, but only requires a passive electrically conductive structure.

In another example, the electrical bridge contact comprises a first electrical contact terminal and a second electrical contact terminal. The first electrical contact terminal and the second electrical contact terminal are electrically connected. The first electrical contact terminal and the second electrical contact terminal are spatially separated from each other along the first separation direction parallel to the distance between the first relief part and the third relief part. The amount of spatial separation between the first electrical contact terminal and the second electrical contact terminal is generally greater than the size or width of at least one of the first relief portion and the third relief portion as viewed along the first separation direction.

Typically, the spatial separation between the first electrical contact terminal and the second electrical contact terminal is at least equal to or greater than the size or extent of the second pattern portion located between the first pattern portion and the third pattern portion, as viewed along the first separation direction. In this way, it is ensured that in at least one rotational state or rotational orientation of the first element relative to the second element, the first relief part is electrically connected to the third relief part by means of an electrical bridge contact, namely when the first electrical contact terminal is in electrical connection with the first part. relief, and the second output for electrical contact is in electrical connection with the third part of the relief.

In another example, the first separation direction runs substantially parallel to the imaginary shortest connection between the first relief portion and the third relief portion. For example, if the first and second embossings are striped embossings, the first separation direction is substantially perpendicular to the longitudinal extent of the embossing stripes.

According to a further example, the electrical bridge contact comprises a third electrical contact terminal spatially separated from at least one of the first electrical contact terminal and the second electrical contact terminal along a second separation direction that is not parallel to the first separation direction. In some examples, the second separation direction runs substantially perpendicular to the first separation direction. If the pattern on the first element includes a longitudinal stripe pattern, the first and second electrical contact leads are particularly configured to alternately engage or alternately come into contact with the alternating stripes when the first element is subjected to rotation or helical movement relative to the second element.

As a rule, the first and second leads for electrical contact can be displaced relative to the first element only in the area of the first section of the relief. Moreover, the first section of the relief can be fully equipped with a striped relief containing at least one first, second and at least one third of the relief.

The third electrical contact terminal of the electrical bridge contact may be offset from at least one of the first electrical contact terminal and the second electrical contact terminal, or both of them, along the longitudinal direction. Thus, when the first element is subjected to longitudinal displacement relative to the second element, the third electrical contact lead can move into or onto the second section of the relief. The second relief section may be separated from the first relief section along the longitudinal direction. The second relief section may be out of reach for the first and second electrical contact terminals of the electrical bridge contact, but may only engage with the third electrical contact terminal of the electrical bridge contact. Thus, the interaction of the third electrical bridge with the second relief section may be an indication that a longitudinal end position has been reached, such as a zero dose configuration or an end dose configuration of an injection device.

Accordingly, in another example, the third bridge contact is configured to come into contact with the second section of the relief when the first element and the second element return to their original relative position after the completion of the dose delivery. Thus, the interengagement or contact between the third bridge contact and the second relief section provides a zero dose indicator, thus indicating to the recording device that the end of the dose delivery or release procedure has been reached.

In other examples, the injection device contains two or more electrical bridge contacts that are distributed along the tubular circumference of the first element. Two or more electrical bridge contacts may be located in the same longitudinal position on the second element. They can be located at the same angle or at the same distance from each other along the circumference or along the direction along the tangent surface of the tubular shape of the first element.

Typically, the second element also has a tubular shape. Accordingly, two or more electrical bridge contacts can be separated from each other along the circumference or tangential direction of the second tubular shaped element. Two or more electrical bridge contacts may be implemented identically. Therefore, the first electrical bridge contact has the same shape and geometry as the second electrical bridge contact. The two or more electrical bridge contacts may also be arranged asymmetrically along the circumference of the second element. Therefore, the distance or angular distance between the first and second electrical bridge contacts may be different from the distance or angular distance between the second and third electrical bridge contacts. The geometric arrangement of two or more electrical bridge contacts depends on the pattern coding on the first element.

In another example, two or more electrical bridge contacts and the first and third relief parts are arranged such that in any available rotational position of the first element relative to the second element, at least one of the first relief parts is electrically connected to at least one of the third relief part by means of at least one of the bridge contacts. Thus, at least one of the first parts of the relief is energized if at least one third of the relief is connected to a voltage source. Thus, an unambiguous electrical signal can be applied for each available rotational position of the first element relative to the second element.

In another example, the electrical bridge contact comprises a body made of sheet metal and further comprising at least one flexible tab. At least one of the first electrical contact terminal and the second electrical contact terminal is located at the free end of at least one flexible tab. The electrical bridge may comprise a plurality of flexible legs, such as a first flexible leg, a second flexible leg, and optionally also a third flexible leg. Typically, the first electrical contact terminal is located near or at the free end of the first flexible leg of the electrical bridge contact. The second output for electrical contact is placed or located at the free end of the second flexible foot of the electrical bridge contact. This may also apply to the optional third terminal for electrical contact. A third terminal for electrical contact may also be provided and located near or at the free end of the third flexible leg of the electrical bridge contact.

The electrical bridge contact may be attached to the second element or may be built into it. For example, the electrical bridge contact is molded with an insert in or on a second member, which may contain an injection molded plastic component. Typically, at least one flexible tab of the electrical bridge may be radially displaced or prestressed towards the surface of the tubular shape of the first element. This ensures continuous mechanical contact between the at least one tab and/or the corresponding terminal for electrical contact with the pattern on the surface of the tubular mold.

At least the first electrical contact lead may protrude from at least the first flexible leg of the electrical bridge contact. It may comprise an embossed domed or spherical structure integrally formed in the sheet metal and projecting from the flexible tab towards the surface of the tubular shape of the first element. An electrical bridge contact can be made by metal stamping. It may contain stainless steel. The electrical contact terminals may comprise a domed embossed protrusion in the flexible tab, characterized by only a relatively low degree of static or dynamic friction against the relief.

The at least one flexible tab may comprise or form a cantilever to provide adequate radial contact pressure between the pattern and the electrical bridge. The preload and/or radial deformation of at least one flexible tab must be at least within the range of manufacturing and/or assembly tolerances of the injection device. Thus, potential manufacturing or assembly tolerances can easily be compensated for.

In an additional example, the injection device comprises at least one cleaning pad located in or on the second element spaced from at least one electrical contact lead along at least one of the first movement and the second movement. The cleaning pad is generally in frictional engagement with the surface of the tubular shape of the first element. At least one cleaning pad is in mechanical and frictional engagement with those parts of the surface relief of the tubular shape that will come into electrical contact with at least one electrical contact terminal when the first element undergoes one of the first movement and the second movement relative to the second element.

Thus, those portions of the surface of the tubular shape that will come into electrical contact with the at least one electrical contact terminal will be cleaned. In this way, a fairly continuous and reliable electrical contact can be established and maintained between the electrically conductive relief and the at least one electrical contact terminal. Moreover, particles such as dust particles that may accumulate on the surface of the tubular mold can be wiped off. Thus, their potentially detrimental effect on electrical contact between the at least one electrical contact terminal and the electrically conductive pattern can be reduced. Moreover, by cleaning the surface of the tubular mold, abrasion or wear caused by the sliding movement of the at least one electrical contact lead along the pattern can be effectively reduced.

Typically, in another example, the cleaning patch comprises one of an elastomeric material and a textile material. The cleaning pad faces the relief. The cleaning pad is configured to frictionally engage with the first element when the first element undergoes one of a first movement and a second movement relative to the second element. The elastomeric or textile material of the cleaning pad is preferred for the long lasting gentle cleaning effect of the corresponding cleaning pad. In a further example, the cleaning pad may resiliently deform or rotate about the longitudinal direction as a deformation axis or a rotation axis.

Compared to a windshield wiper blade, the wiper pad may have a geometric shape tapering or converging towards the first element. It can additionally rotate or elastically deform due to the rotation of the first element relative to the second element. For example, when the first element is subjected to a helical motion along the first direction of rotation, the cleaning pad may automatically rotate to increase its contact surface with the surface of the tubular shape. When the helical movement is terminated, the at least one cleaning pad may return to its original configuration in which it has only a relatively small contact area or surface of contact with the surface of the tubular shape of the first element. Thus, abrasion or wear on the surface of the tubular shape and the pattern provided thereon can be reduced.

In another example, the length of longitudinal movement of the first element relative to the second element during the first movement is identical to the length of the longitudinal movement of the first element relative to the second element during the second movement. At least one of the contact leads is in a first rotational position with respect to the relief before the first element and the second element undergo the first movement. When the helical movement of the first element relative to the second element during one of the first movement and the second movement involves a non-integer multiple rotation of the first element relative to the second element, at least one of the contact leads is in the second rotational position after completion of the second movement. In this case, the second pivot position and the first pivot position are different from each other.

Accordingly, in the first pivotal position, the first part of the relief is in contact with at least one contact terminal. In the second pivot position, a different and therefore different part of the relief is in contact with at least one contact terminal. This configuration is quite advantageous for reducing the abrasion or wear pattern on the surface of the tubular shape of the first element. At least one or more leads for contacting the recording device and/or the reference element may be in constant mechanical contact with the surface of the tubular shape of the first element. Since the first element is only subjected to rotation during the first movement, and since a dose setting involving a whole or integer multiple rotation of the first element relative to the second element can only represent an exceptional and rather rare case, the surface of the tubular shape is loaded quite uniformly in terms of friction from at least at least one pin for contact.

In another example, the recording device is located on the second element. In this case, at least one electrical sensor contains at least the first output for electrical contact located on the second element. The first terminal for electrical contact is configured to alternately enter into mechanical and electrical contact with the first relief part and the second relief part when the first element undergoes one of the first movement and the second movement relative to the second element. In such a configuration, a binary encoder based on a 2-bit Gray code can be implemented. Typically, the electrical sensor comprises at least one first electrical contact terminal and a second electrical contact terminal distributed or positioned along the tubular circumference of the first element along the first separation direction.

The spacing between adjacent electrical contact terminals and the spacing between adjacent first and second relief portions may be substantially the same. Moreover, the periodicity of the location of the plurality of electrical contact terminals and the periodicity of the relief may be substantially the same. In such a configuration, at least two or all of the available sensor leads can simultaneously create or modify an electrical signal. In this case, the second sensor output may duplicate the first sensor output, and the recording device contains the appropriate means for providing redundancy and fault tolerance.

In other examples, the spatial or angular distance between adjacent contact leads and adjacent first and second relief portions differ from each other. Thus, separate leads for electrical sensor contact provide different and/or alternating electrical signals when the first element is subjected to at least one of the first movement and the second movement relative to the second element, in particular when the first element is subjected to rotation relative to the second element during screwing. movement.

In another example, the distance between adjacent contact leads along the first separation direction is less than the spatial extension of at least one of the first relief portion and the second relief portion along the first separation direction. Thus, the situation can be achieved that there will be at least some rotational states of the first element with respect to the second element, in which not one, but two contact leads will be electrically connected to the same part of the relief. This may be advantageous for generating a binary signal, for example for implementing a 2-bit Gray code or an incremental encoder.

In all of the examples described herein, the first and second elements may be implemented as arbitrary components of an injection device, typically a pen-type injection device, which undergo a first movement relative to each other during dose setting and which undergo a second movement relative to each other during the time of issuance or release of the dose. The first and second elements may be located inside the body of the injection device. They may not be visible from the outside of the injection device. The first and second elements may be implemented as components of the transmission mechanism of the injection device. The first and second elements may generally be indirectly engaged to provide helical movement in one longitudinal direction and to provide sliding displacement without rotation along the opposite longitudinal direction. The transmission mechanism, as a rule, contains a clutch that is in mechanical engagement with the first element and with the second element. The clutch contains at least two configurations. In one configuration of the coupling, the first element may be displaced relative to the second element along the helical direction. In the second clutch configuration, the first element can be displaced relative to the second element along a longitudinal sliding movement without rotation.

Typically, the first element undergoes helical and proximally directed movement relative to the second element during dose setting, and the first element undergoes non-rotational sliding displacement relative to the second element during dose delivery or release.

As a rule, the longitudinal or axial position of the first element relative to the second element before the dose is set is identical to the axial or longitudinal position of the first element relative to the second element after the issuance or release of the dose.

In other examples, the second element is a tubular-shaped injection device housing component. The second element may include a proximal housing component configured to receive a kit nozzle and/or injection device transmission mechanism. In this case, the first element may belong to a nozzle for an injection device set. The first element may comprise a tubular cylinder supporting and/or mechanically supporting the dose dial element. Alternatively, the first element may be integral with the dose set element. Typically, when it undergoes a first movement relative to the second element, the first element protrudes in a proximal direction from the second element.

By way of example only, an injection device and recording device as described herein are suitable for implementation in a drug delivery device as described in WO 2010/052275 A2. In this case, the cylindrical enclosing cylinder of the dispensing assembly may represent the second element according to the present invention, and the dose selection element may represent the first element according to the present invention. In this document, the dose selection element is subjected to a proximally directed helical movement to set the dose and is subjected to a distally directed movement without rotation relative to the female cylinder to deliver the dose.

The remaining parts of the injection device, which are required to install and dispense a dose of drug from the cartridge, are not illustrated in detail in this case. They may be implemented identically or in the same manner as described in WO 2010/052275 A2, the contents of which are incorporated herein by reference in their entirety.

In another aspect, the present invention relates to a recording device adapted to register the relative movement between the first element and the second element of the injection device. The recording device contains at least one electrical sensor and at least one reference element. One of the electrical sensor and reference element is located on the first element, and the other of the electrical sensor and reference element is located on the second element. The first element is movable relative to the second element for installation and for dispensing or dispensing a dose of the drug contained in the cartridge located inside the injection device.

During and to set the dose of the drug, the first element undergoes a first movement relative to the second element. The first element undergoes a second movement relative to the second element for issuing a dose. One of the first movement and the second movement is a helical movement, and the other of the first movement and the second movement is a sliding movement without rotation in the longitudinal direction. Typically, the first element and the second element are aligned. The first and/or second elements may comprise an elongated tubular body. Typically, both the first element and the second element have a tubular geometry. They can move telescopically. Typically, the first movement is a helical movement during which the first element is longitudinally and pivotally displaced relative to the second element in the longitudinal proximal direction. During the second movement, the first element can be displaced longitudinally and without rotation in the distal direction relative to the second element.

The recording device further comprises a relief provided or located on the surface of the tubular shape of the first element. The relief is subjected to longitudinal or helical movement relative to the reference element during at least one of the first movement and the second movement of the first element relative to the second element. The recording device contains at least one electrical sensor, which is adapted to generate electrical signals in response to a change in the position of the relief relative to the reference element.

The recording device is suitable for inclusion in or incorporation into various injection devices, typically pen-type hand-held injection devices. Such injection devices can be made in the form of reusable devices, and the cartridge containing the drug is replaceable. The recording device is also suitable for disposable injection devices, which must be completely disposed of when the drug provided in the cartridge is used or no longer needs to be used.

The recording device, in particular the electrical sensor and its relief, may contain any of the features mentioned above in relation to the injection device.

As used herein, the term "distal" or "distal end" refers to the end of an injection device that faces the injection site of a human or animal. The term "proximal" or "proximal end" refers to the opposite end of the injection device that is furthest away from the injection site of a human or animal.

The term "drug" or "drug" as used herein means a pharmaceutical composition containing at least one pharmaceutically active compound,

wherein in one embodiment the pharmaceutically active compound has a molecular weight of up to 1500 Da and/or is a peptide, protein, polysaccharide, vaccine, DNA, RNA, enzyme, antibody or fragment thereof, hormone, or oligonucleotide, or a mixture of the above pharmaceutically active connections,

wherein, in a further embodiment, the pharmaceutically active compound is useful for the treatment and/or prevention of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolic disorders such as deep vein thromboembolism or pulmonary thromboembolism, acute coronary syndrome ( ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis,

wherein in an additional embodiment, the pharmaceutically active compound contains at least one peptide for the treatment and/or prevention of diabetes mellitus or complications associated with diabetes mellitus, such as diabetic retinopathy,

wherein in a further embodiment, the pharmaceutically active compound comprises at least one human insulin or human insulin analogue or derivative, glucagon-like peptide (GLP-1) or analogue or derivative thereof, or exendin-3 or exendin-4 or exendin-4 analogue or derivative 3 or exendin-4.

Insulin analogues are, for example, Gly(A21), Arg(B31), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin, in which the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala, and in which Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin; and Des(B30) human insulin.

Derivatives of insulin are, for example, B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-Υ-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-Υ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin; and B29-N-(ω-carboxyheptadecanoyl) human insulin.

Exendin-4, for example, means exendin-4(1-39), a peptide of the sequence H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu- Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

Exendin-4 derivatives, for example, are selected from the following list of compounds:

H-(Lys)4-des Pro36, des Pro37 exendin-4(1-39)-NH2,

H-(Lys)5-des Pro36, des Pro37 exendin-4(1-39)-NH2,

des Pro36 exendin-4(1-39),

des Pro36 [Asp28] exendin-4(1-39),

des Pro36 [IsoAsp28] exendin-4(1-39),

des Pro36 [Met(O)14, Asp28] exendin-4(1-39),

des Pro36 [Met(O)14, IsoAsp28] exendin-4(1-39),

des Pro36 [Trp(O2)25, Asp28] exendin-4(1-39),

des Pro36 [Trp(O2)25, IsoAsp28] exendin-4(1-39),

des Pro36 [Met(O)14 Trp(O2)25, Asp28] exendin-4(1-39),

des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] exendin-4(1-39); or

des Pro36 [Asp28] exendin-4(1-39),

des Pro36 [IsoAsp28] exendin-4(1-39),

des Pro36 [Met(O)14, Asp28] exendin-4(1-39),

des Pro36 [Met(O)14, IsoAsp28] exendin-4(1-39),

des Pro36 [Trp(O2)25, Asp28] exendin-4(1-39),

des Pro36 [Trp(O2)25, IsoAsp28] exendin-4(1-39),

des Pro36 [Met(O)14 Trp(O2)25, Asp28] exendin-4(1-39),

des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] exendin-4(1-39),

while the -Lys6-NH2 group may be linked to the C-terminus of the exendin-4 derivative;

or a derivative of exendin-4 sequence

des Pro36 exendin-4(1-39)-Lys6-NH2 (AVE0010),

H-(Lys)6-des Pro36 [Asp28] exendin-4(1-39)-Lys6-NH2,

des Asp28 Pro36, Pro37, Pro38 exendin-4(1-39)-NH2,

H-(Lys)6-des Pro36, Pro38 [Asp28] exendin-4(1-39)-NH2,

H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28] exendin-4(1-39)-NH2,

des Pro36, Pro37, Pro38 [Asp28] exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28] exendin-4(1-39)-(Lys)6-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28] exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36 [Trp(O2)25, Asp28] exendin-4(1-39)-Lys6-NH2,

H-des Asp28 Pro36, Pro37, Pro38 [Trp(O2)25] exendin-4(1-39)-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] exendin-4(1-39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] exendin-4(1-39)-NH2,

des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] exendin-4(1-39)-(Lys)6-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36 [Met(O)14, Asp28] exendin-4(1-39)-Lys6-NH2,

des Met(O)14 Asp28 Pro36, Pro37, Pro38 exendin-4(1-39)-NH2,

H-(Lys)6-desPro36, Pro37, Pro38 [Met(O)14, Asp28] exendin-4(1-39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] exendin-4(1-39)-NH2,

des Pro36, Pro37, Pro38 [Met(O)14, Asp28] exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] exendin-4(1-39)-(Lys)6-NH2,

H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28] exendin-4(1-39)-(Lys)6-NH2,

H-Lys6-des Pro36 [Met(O)14, Trp(O2)25, Asp28] exendin-4(1-39)-Lys6-NH2,

H-des Asp28 Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25] exendin-4(1-39)-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] exendin-4(1-39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] exendin-4(1-39)-NH2,

des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] exendin-4(1-39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] exendin-4(S1-39)-(Lys)6-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] exendin-4(1-39)-(Lys)6-NH2;

or a pharmaceutically acceptable salt or solvate of any of the aforementioned exendin-4 derivatives.

Hormones are, for example, pituitary hormones, or hypothalamic hormones, or regulating active peptides and their antagonists, as described in Rote Liste, ed. 2008, chapter 50, such as gonadotropin (follitropin, lutropin, human chorionic gonadotropin, menotropin), somatropin (somatotropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, goserelin.

The polysaccharide is, for example, glycosaminoglycan, hyaluronic acid, heparin, low molecular weight heparin, or ultra-low molecular weight heparin, or a derivative or sulfated, for example polysulfated, form of the aforementioned polysaccharides, and/or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of polysulphated low molecular weight heparin is enoxaparin sodium.

Antibodies are globular plasma proteins (~150 kDa), which are also known as immunoglobulins, having a common basic structure. Because they have sugar chains added to amino acid residues, they are glycoproteins. The basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only one Ig unit); secreted antibodies can also be dimeric with two Ig units, as with IgA, tetrameric with four Ig units, as with teleost fish IgM, or pentameric with five Ig units, as with mammalian IgM.

The Ig monomer is a Y-shaped molecule that consists of four polypeptide chains; two identical heavy chains and two identical light chains linked by disulfide bonds between cysteine residues. Each heavy chain is approximately 440 amino acids long; each light chain is approximately 220 amino acids long. Each heavy and light chain contains intrachain disulfide bonds that stabilize their folding. Each chain is made up of structural domains called Ig domains. These domains contain approximately 70-110 amino acids and are classified into different categories (eg variable or V and constant or C) according to their size and function. They have a characteristic immunoglobulin chain folding feature in which two β-sheets create a "sandwich" shape, held together by an interaction between stable cysteines and other charged amino acids.

There are five types of mammalian Ig heavy chain, designated α, δ, ε, γ, and μ. The type of heavy chain present determines the isotype antibodies; these chains can be found in IgA, IgD, IgE, IgG and IgM antibodies, respectively.

Individual heavy chains differ in size and composition; α and γ are approximately 450 amino acids and δ are approximately 500 amino acids while μ and ε are approximately 550 amino acids. Each heavy chain has two regions, a constant region (C _H ) and a variable region (V _H ). In one view, the constant region is essentially identical in all antibodies of the same isotype, but differs in antibodies of different isotypes. Heavy chains γ, α and δ have a constant region consisting of three tandem Ig domains and a hinge region for added flexibility; μ and ε heavy chains have a constant region consisting of four immunoglobulin domains. The heavy chain variable region differs in antibodies produced by different B cells, but is the same for all antibodies produced by a single B cell or B cell clone. The variable region of each heavy chain is approximately 110 amino acids long and consists of a single Ig domain.

Mammals have two types of immunoglobulin light chain, designated λ and κ. The light chain has two consecutive domains: one constant domain (CL) and one variable domain (VL). The approximate length of the light chain is 211-217 amino acids. Each antibody contains two light chains that are always identical; however, only one type of light chain, κ or λ, is present in a mammalian antibody.

Although the general structure of all antibodies is very similar, the unique property of a given antibody is determined by the variable (V) regions, as detailed above. More specifically, variable loops, three on each light (VL) and three on the heavy (VH) chain, are responsible for antigen binding, i. for their antigenic specificity. These loops are called hypervariable regions (CDRs). Because the CDRs from both the VH and VL domains contribute to the antigen-binding site of an antibody, it is the combination of the heavy and light chains, not the two alone, that determines the ultimate antigen specificity.

The term "antibody fragment" encompasses at least one antigen-binding fragment as defined above and exhibits substantially the same function and specificity as the complete antibody from which the fragment is derived. Limited proteolytic cleavage with papain cleaves the prototype Ig into three fragments. Two identical amino-terminal fragments, each containing one full L-chain and approximately half of the H-chain, are antigen-binding fragments (Fab). A third fragment, similar in size but containing the carboxyl terminal half of both heavy chains with their interchain disulfide bond, is the crystallizable fragment (Fc). Fc contains carbohydrates, complement binding and FcR binding sites. Limited pepsin digestion yields one fragment F(ab')2 containing both parts of the Fab and a hinge region, including an interchain H-H disulfide bond. F(ab')2 is divalent for antigen binding. The F(ab')2 disulfide bond can be cleaved to give Fab'. In addition, the heavy and light chain variable regions can be fused together to form a single chain variable fragment. (scFv).

Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts. Acid addition salts are, for example, HCl or HBr salts. Basic salts are, for example, salts with a cation selected from alkalis or alkaline compounds, for example Na+ or K+ or Ca2+ or the ammonium ion N+(R1)(R2)(R3)(R4) where R1-R4 are independently from the other means: hydrogen, an optionally substituted C1-C6 alkyl group, an optionally substituted C2-C6 alkenyl group, an optionally substituted C6-C10 aryl group or an optionally substituted C6-C10 heteroaryl group. Additional examples of pharmaceutically acceptable salts are described in "Remington's Pharmaceutical Sciences" 17th ed. Alfonso R. Gennaro (ed.), Mark Publishing Company, Easton, PA, USA, 1985 and in Encyclopedia of Pharmaceutical Technology.

Pharmaceutically acceptable solvates are, for example, hydrates.

Moreover, those skilled in the art will appreciate that various modifications and variations may be made to the present invention without departing from the scope of the present invention. Furthermore, it is worth noting that any reference numerals used in the appended claims should not be construed as limiting the scope of the present invention.

Brief description of graphic materials

In the following, several examples of a drug delivery device, a drug delivery system, and a method for controlling at least one release or dispensing parameter of the drug delivery device are described in detail with reference to the drawings, in which:

in fig. 1 schematically shows a pen-type injection device,

in fig. 2 is a schematic illustration of the first and second elements of the injection device before the dose setting procedure,

in fig. 3 is a schematic illustration of the first and second elements during or after dose setting,

in fig. 4 shows the first and second elements during the delivery or release of a dose,

in fig. 5 shows another example of the first and second elements during or after dose setting, and

in fig. 6 is an illustration of the example of FIG. 5 during dose dispensing,

in fig. 7 is an illustration of the first element with respect to the reference element,

in fig. 8 shows another example of the first element,

in fig. 9 shows a further example of the first element of the tubular shape,

in fig. 10 is a cross-sectional view of the first and second elements in the first rotational state or configuration of the first element,

in fig. 11 shows the arrangement of FIG. 10 with the first element in a different rotational state than the configuration of FIG. 10,

in fig. 12 is an exploded view of one embodiment of an injection device,

in fig. 13 is a longitudinal sectional perspective view of the device of FIG. 12,

in fig. 14 is a side view of a further example of the first element,

in fig. 15 is a perspective illustration of the first element of FIG. 14,

in fig. 16 is an illustration of the first element of FIG. 14 and 15 together with the reference element,

in fig. 17 is a cross-sectional view of the assembly of FIG. 16 with three separate reference elements,

in fig. 18 is a schematic cross section of FIG. 17 illustrating an electrical diagram of the relief provided on the first element with respect to the reference elements,

in fig. 19 shows the geometric structure of the surface relief of the tubular shape of the first element according to FIG. 14-18,

in fig. 20 shows another example of a recording device containing only two reference elements, in connection with another example of relief on the surface of the tubular shape of the first element,

in fig. 21 shows the geometric structure of the relief according to FIG. 20,

in fig. 22 are schematic illustrations of the first, second and third terminals for the electrical contact of the orienting element in the first longitudinal position of the first element relative to the orienting element,

in fig. 23 shows the configuration of FIG. 22, with the first element in a second longitudinal position relative to the second element,

in fig. 24 shows the example of FIG. 16 with the first element close to the zero dose longitudinal position,

in fig. 25 shows the arrangement of FIG. 24, with the first element in the zero dose longitudinal position relative to the second element,

in fig. 26 shows a separate view of the landmark element in accordance with FIG. 16, 17, 24 and 25,

in fig. 27 is a perspective view of the proximal end of the injection device body with at least one orienting element of FIG. 26,

in fig. 28 is an illustration of another example of relief provided on the tubular surface of the first element,

in fig. 29 is an illustration of another example of a recording device, the reference element having three electrical contact leads located on the second element,

in fig. 30 is an illustration of the electrical circuit of the electrical sensor of FIG. 29,

in fig. 31 is an illustration of the first rotational state of the first element relative to the landmark,

in fig. 32 is an illustration of the second rotational state of the first element relative to the landmark,

in fig. 33 is an illustration of the third rotation state of the first element relative to the landmark, and

in fig. 34 is an illustration of the fourth rotational state of the first element relative to the landmark,

in fig. 35 shows a further example of a recording fixture in another example of an electrical sensor in idle state,

in fig. 36 is an illustration of the example of FIG. 35, with the electrical sensor in the activated state,

in fig. 37 is an illustration of another example of a recording device,

in fig. 38 is an illustration of an additional example of a recording device,

in fig. 39 shows another example of an orientation element containing five contact leads located along the inner circumference of the second element of the tubular shape,

in fig. 40 is a perspective illustration of another example of a first element adapted and capable of handling orienting elements as illustrated in FIG. 39,

in fig. 41 shows the first element of FIG. 40 and the second element of FIG. 39 in assembled configuration,

in fig. 42 schematically illustrates the relative position of at least one cleaning pad with respect to at least one electrical sensor contact terminal in a side view of the first and second elements,

in fig. 43 is a cross-sectional view of the arrangement of FIG. 42.

Detailed description

In FIG. 1 schematically illustrates an example of an injection device. The injection device 1 may include a pre-filled disposable injection device. The injection device 1 includes 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 which is configured to enclose and protect the distal section of the injection housing 10. device 1. The housing 10 may contain and form the main part of the housing, made with the possibility of receiving the transmission mechanism 8. The injection device 1 may further include a distal component of the housing, called the holder 14 of the cartridge. Cartridge holder 14 may be integrally or releasably connected to main body 10. Cartridge holder 14 is typically configured to receive a cartridge 6 that is filled with a liquid drug. The cartridge 6 contains a capsule 25 of a cylindrical or tubular shape, hermetically closed in the proximal direction 3 by a plug 7 located inside the capsule 25. The plug 7 is displaceable relative to the capsule 25 of the cartridge 6 in the distal direction 2 by means of the piston rod 20. The distal end of the cartridge 6 is hermetically sealed by a piercing seal 26, made in the form of a septum and pierced by the pointed end of the injection needle 15 directed in the proximal direction. 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 providing access to the interior of the cartridge 6 for fluid transfer.

In cases where the injection device 1 is configured to administer, for example, human insulin, the dosage set by the dial element 12 at the proximal end of the injection device 1 can be displayed in so-called international units (IU), with 1 IU representing is the biological equivalent of approximately 45.5 micrograms of pure crystalline insulin (1/22 mg).

As shown further in FIG. 1, the body 10 includes a dosage window 13, which may be in the form of an opening in the body 10. The dosage window 13 allows the user to view a limited portion of the number cylinder that is movable when the dose dialing element 12 is, for example, in the form of a set, rotates, providing a visual display of the dose set at that moment. The dose dial element can rotate in a helical path relative to the housing 10 when rotated during installation and/or dispensing or administering a dose. During and to set the dose, the dose dial element 12 is generally rotated clockwise in the dose increase direction 4 . If the dose actually set is too high, the dose dial element 12 can be turned in the opposite direction, ie in the dose reduction direction 5 .

In FIG. 2-4 show an illustration of one example of a recording device 50 adapted to register and quantify the relative movement between the first element 100 and the second element 200 of the injection device 1. In this case, the first element 100 undergoes a first movement relative to the second element 200, as illustrated in FIG. . 3. The first movement is a helical movement, that is, the combined rotational and longitudinal movement of the first element 100 relative to the second element 200. During the first movement, the first element 100 may be subjected to a clockwise rotational movement relative to the second element 200. At the same time, it may be subjected to longitudinal movement in the proximal direction 3. During dose setting, the first element 100 undergoes a first movement relative to the second element 200, as illustrated in FIG. 3.

The first element 100 is also subject to a second movement relative to the second element 200. In this case, the second movement is a longitudinal movement of the first element 100 relative to the second element 200 along the second longitudinal direction, i.e. in the distal direction 2. The second movement is a sliding movement of the first element 100 relative to the second element 200, wherein the first element 100 cannot rotate relative to the second element 200. That is, during the second movement, the first element 100 cannot rotate relative to the second element 200. The second element 200 is equipped with at least one orienting element 60. The orienting element 60 is attached to the second element 200. It may be located at the proximal end of the second element 200.

The recording device 50 includes at least one electrical sensor 51 and a tubular-shaped surface 102. A tubular-shaped surface 102 is provided on the first element 100. Typically, the first element 100 also has a tubular shape. The first element 100 may include a cylinder, such as a dose dial cylinder or a dosage cylinder, operatively connected to or integrally formed with the dose dial element 12, as illustrated in FIG. 1. Recording device 50 includes at least one electrical sensor 51 that is adapted to generate electrical signals in response to a change in position of relief 104 relative to reference element 60 during at least one of the first movement and second movement of the first element 100 relative to the second element 200 The orienting element 60 is located on or embedded in the second element 200. At least one electrical sensor 51 may coincide with the reference element 60. In other examples, at least one electrical sensor 51 may be embedded in or located on the first element 100. The orienting element 60 may then be a passive electrical or electronic element adapted to interact with at least one electrical sensor 51 located on the first element 100.

The pattern 104 is designed and configured to interact with at least one electrical sensor 51 such that the movement of the pattern 104 according to at least one of the first movement and the second movement can be detected and/or can be quantified by the at least one electrical sensor. . As the structure of the relief 104 changes due to the movement of the relief 104 relative to the reference element 60, at least one electrical sensor 51 generates an electrical signal or modifies an electrical signal, which electrical signal can be processed by the recording device 50 to register and/or quantify at least one of the type of movement, the amount of movement, the position and orientation of the first element relative to the second element.

The at least one electrical sensor 51 is particularly adapted to directly register and/or to directly quantify the change in position of the relief 104 with respect to at least one reference element 60. That is, the at least one electrical sensor 51 interacts with the interface between the first element 100 and the second element 200.

At least one electrical sensor 51 is adapted to register and/or quantify at least one of the helical movement and the sliding movement of the first element 100 relative to the second element 200. The electrical sensor 51 may further be configured to register and/or quantify measuring both the rotational movement and the longitudinal movement of the relief 100 relative to the landmark 60.

In FIG. 2-4, the tube-shaped surface 102 is the outer surface of the first tube-shaped member 100. The second element 200 may be implemented as another tubular element. Both the first element 100 and the second element 200 may be tubular in shape. They can be arranged in a nested, i.e. telescoping, configuration. During dose setting, the total longitudinal extension of the assembly of first element 100 and second element 200 is greater than at the end of the dose delivery procedure, as illustrated in FIG. 2. The second element 200 is typically a tubular-shaped hollow cylinder. At least one reference element 60 is generally located on the inner side wall of the cylinder of the second element 200. Thus, also at least one electrical sensor 51 is located on the radially inward portion of the second element 200. The free inner diameter of the second element 200 is larger, than the outer diameter of the first element 100. That is, the first element 100 can be displaced in the longitudinal direction inside the second element 200.

In the example of FIG. 5 and 6, the first element 100 is again provided with a tubular-shaped surface 102 containing a relief 104. But in this case, the tubular-shaped surface 102 is the inwardly facing surface of the first hollow-shaped element 100. The second element 200 can be displaced in the longitudinal direction without rotation relative to the first element 100 during dose setting, as illustrated in FIG. 5. In this case, the second element 200 is subjected to a proximally directed longitudinal sliding movement relative to the first element 100 during and/or to set the dose. Landmark 60 and at least one electrical sensor 51 are located and made on the outer circumference of the second element 200. The second element 200 may have a tubular shape. It contains an outside diameter that is smaller than the free inside diameter of the first element 100.

For the delivery of a dose, or during the delivery of a dose, the second element 200 undergoes a helical movement with a longitudinal displacement component in the longitudinal distal direction 2. In this case, the orientation element 60 and at least one electric sensor 51 undergo a combined rotational and longitudinal movement relative to the relief 104 and, therefore , with respect to the first element 100. As illustrated in FIG. 5 and 6, the first movement, as shown in FIG. 5 is a sliding movement of the first element 100 relative to the second element 200 along the longitudinal proximal direction 3, while the first element 100 and the second element 200 cannot rotate.

The second movement, as illustrated in FIG. 6 is a helical movement of the second member 200 relative to the first member 100 with longitudinal displacement in the distal direction 2. It should be noted that the tubular relief 104 may cover the entire inner circumference of the first hollow member 100. Thus, for any available rotational state of the second element 200 relative to the first element 100, there will be a certain relative and distinctive position or orientation of the relief 104 relative to at least one reference element 60 or electrical sensor 51.

In FIG. 7 illustrates another example of a recording device 50. In this case, the second element 200 is provided with two reference elements 60 which are located on or in the second element 200 at a predetermined longitudinal distance from each other. In FIG. 7, the second element is only shown in dotted lines when the first element 100 is in a zero dose configuration, such as at the end of a dose dispensing procedure. In this case, the first element 100 is in the most distal position relative to the second element 200.

As illustrated in FIG. 7, the relief 104 has a longitudinal extension that corresponds to a substantially longitudinal distance between the first and second landmarks 60, each of which overlaps or coincides with the first and second electrical sensors 51. In the initial configuration, as illustrated in FIG. 7, one of the landmarks 60 and electrical sensor 51 is located at the proximal end of the pattern 104, while the other of the landmark 60 and the electrical sensor 51 is located near or close to the distal end of the pattern 104.

As the first element 100 undergoes the first movement, and as the first element 100 is displaced in the proximal direction 3 relative to the second element 200, the relief 104 begins to separate from the distally located reference element 60 and from the distally located electrical sensor 51. Accordingly, the movement of the first element 100 relative to the second element 200 is registered and/or quantitatively measured only by means of a proximally located reference element 60 and a corresponding proximally located electrical sensor 51.

As the first element 100 approaches the zero dose configuration, as illustrated in FIG. 7, at the end of the dose delivery procedure, the relief 104, typically the distal portion of the relief 104, returns to the coverage area of the distal orientation element 60 and/or the distal electrical sensor 51. The first element 100 approaches and/or reaches the zero dose configuration, therefore, can be separately recorded by the distal electrical sensor 51. In this case, the distal electrical sensor 51 may be limited to providing a switch function configured to indicate to the recording device 50 that the zero dose configuration has been reached. Another and therefore proximally located electrical sensor 51 can thus be configured and adapted to register and/or to quantify the distance or angular distance over which the first element 100 has been moved during at least one of the first movement and the second movement relative to second element 200.

As further illustrated in FIG. 7, relief 104 may include a first relief section 120 and a second relief section 122. The first and second relief sections 120, 122 are located without overlapping on the surface 102 of the tubular shape of the first element 100. The second relief section 122 is separated from the first relief section 120 at least in the longitudinal direction.

Typically, the second relief section 122 may have an annular shape. It may be invariant with respect to the rotational state or orientation of the first element 100 relative to the second element 200. It may in particular be configured to register a predetermined longitudinal position of the first element 100 relative to the second element 200. In contrast, the first relief section 120 may be configured and designed to support and provide for the registration and/or quantitative measurement of the degree of rotation or longitudinal displacement of the relief 104 relative to the reference element 60. In some examples, the interaction of the first section 120 of the relief with the landmark element 60 and at least one electrical sensor 51 is adapted to exclusively register and/or to quantify the degree of rotation of the first element 100 relative to the second element 200.

To do this, the first relief section 120 may be invariant in the longitudinal direction (z), therefore, longitudinal displacement without rotation of the first element 100 relative to the second element 200 may not generate an electrical signal using at least one electrical sensor 51. This is especially true in the situation, when the relief 104, in particular the first relief section 120, comprises a striped relief 124 as illustrated in FIG. 8. The striped pattern 124 may comprise a plurality of longitudinal strips 126 extending parallel to the longitudinal direction or parallel to the extension of the first tubular shaped element 100. In another example, as illustrated in FIG. 9, the first pattern section 120 also includes a striped pattern 124. But in it, the longitudinal strips 126 extend at a predetermined angle relative to the longitudinal direction (z).

The angle of the longitudinal strips relative to the longitudinal direction may differ from the helical pitch between the first element 100 and the second element 200. In this case, and as the first element 100 undergoes helical movement relative to the second element 200, at least one electrical sensor will be adapted to generate varying electrical signals indicating the degree of rotational displacement of the first element 100 relative to the second element 200. Due to the angled stripe pattern as illustrated in FIG. 9, varying electrical signals will also be generated when the first element 100 is subjected to longitudinal sliding movement without rotation relative to the second element 200.

As illustrated in FIG. 8 and 9, relief 104 comprises a first relief section 120 which is particularly designed and intended to register and/or quantify the degree of rotation of the first element 100 relative to the second element 200. In FIG. 8, the second relief section 122 is located adjacent the proximal end of the first relief section 120. In FIG. 9, the second relief section 122 is adjacent to the distal end of the first relief section 120. In the configuration of FIG. 8 and when the second relief section 122 is close to or adjacent to the proximal end of the first relief section 120, the respective electrical sensors 51, in particular those capable of detecting and/or measuring rotational movement and longitudinal movement, can be located close to each other. . Moreover, separate electrical sensors 51 may be combined into as little as one electrical sensor 51 and may be embedded in as little as one landmark member 60 located near or on the proximal end of the second member 200.

Typically, there is no limitation in terms of physical or technical interaction between the relief 104 and the at least one electrical sensor 51.

Typically, relief 104 includes at least a first relief portion 110 and at least a second relief portion 112. The first and second relief portions 110, 112 are arranged without overlapping on the surface 102 of the tubular shape of the first element 100. The first relief portion 110 and the second relief portion 112 are characterized by at least one of the following parameters: electrical conductivity, optical transparency, optical reflectivity, magnetic susceptibility or electrical susceptibility. Moreover, the first and second relief parts 110, 112 may also differ from each other with respect to the radial position relative to the central axis of the tubular surface 102 or relative to the central axis of the first tubular shaped element 100. For example, the first relief portion 110 may comprise one or more radial projections, and the second relief portion 112 may comprise one or more radial depressions. Radial protrusions and recesses may be provided on the outer surface 102 of the tubular shape of the first element 100 or on the inner surface of the tubular shape of the first element, depending on the specific implementation of the injection device 1 and the registration device 50.

At least one electrical sensor 51 is configured to communicate or interact with the first and second parts 110, 112 of the relief. Therefore, the at least one electrical sensor 51 is configured to discriminate between the first relief portion 110 and the second relief portion 112 if the respective relief portions 110, 112 are within a certain coverage area of the at least one electrical sensor 51. When the first relief portion 110 differs in its electrical conductivity from the second pattern portion 112, the at least one electrical sensor 51 may include an electrical contact terminal 52, thereby allowing the generation of varying electrical signals as the first and second pattern portions 110, 112 pass along at least one electrical sensor 51. When the first and second relief portions 110, 112 have one of excellent optical transparency or optical reflectivity, or when the first and second relief portions 110, 112 have different colors or differ in brightness, at least one electrical sensor 51 may be implemented as an optical sensor, such as a photodiode, adapted to discriminate between relief portions 110, 112 having different optical transparency, different optical reflectivity, or different color, or different brightness.

When the first and second relief portions 110, 112 have different magnetic susceptibility, at least one electrical sensor may be implemented as a magnetic sensor. It may contain a Hall sensing element or a magnetically sensitive electronic structure. The same is true for the combination of at least one electrical sensor with a pattern, where the first and second portions 110, 112 of the pattern have different electrical susceptibility.

When the first and second relief portions 110, 112 have different radial positions or radial mechanical structures, the at least one electrical sensor 51 may be implemented as an electromechanical switch 56, 57, typically radially displaceable and mechanically engaged with at least one of the radial protrusions or radial recesses on the surface 102 of the tubular shape of the first element 100, as illustrated in FIG. 38.

The relief 104 is not limited to the first relief portion 110 and the second relief portion 112 only. A third, fourth, and several additional relief parts can also be provided that are different from each other, thereby allowing not only 2-bit relief to be realized, but also supporting 3-bit, 4-bit, 5-bit, 6-bit, or even n-bit relief, where n is an integer greater than 0.

The type of relief, that is, the type of the first and second relief portions 110, 112 provided in the first relief section 120 and provided in the second relief section 122, may be substantially the same. However, the relief and relief portions 110, 112 of the first relief section 120, in particular their geometry, shape and orientation, may differ from the corresponding relief portions 110, 112 provided in the second relief section 122.

In other examples, the type of the first and second relief portions 110, 112 in the first relief section and the second relief section may be different. For example, the first pattern section 120 may be provided with first and second pattern portions 110, 112 that differ in their electrical conductivity. The first and second relief portions 110, 112 provided in the second relief section 122 may, for example, differ in their radial position. In this case, the first and second relief portions 110, 112 in the second relief section 122 may comprise at least one of the radial recesses or projections.

In FIG. 10, a cross section of the first and second members 100, 200 is illustrated in the first configuration. In this case, the first element 100 includes relief 104 on its outer circumference. The pattern 104 comprises four first pattern portions 110, eg implemented as electrically conductive strips, and further comprises four second pattern portions 112 arranged tangentially between the first pattern portions 110. The second relief portions 112 may be electrically insulating. The electrical sensor 51 includes several leads 52, 53, 54 for electrical contact, which are located on the inner surface of the second element 200.

As illustrated in FIG. 10, the circumferential or tangential distance between adjacent contact leads 52, 53, 54 is substantially equal to the circumferential or tangential distance between adjacent first relief portions 110. In FIG. 10, at least two of the contact leads 52, 53 are in electrical contact with at least two of the first relief portions 110. Moreover, each and all of the conclusions 52, 53, 54 for contact can be in electrical contact with the corresponding first part 110 relief. In the example of FIG. 10 and 11, the first relief portions 110 and the arrangement of the electrical sensor 51 with multiple contact leads 52, 53, 54 have the same periodicity as seen in the circumferential direction or direction along the tangent surface 102 of the tubular shape. So in the configuration of FIG. 10, all or at least some of the contact leads 52, 53, 54 will be electrically connected to at least one of the electrically conductive first relief portions 110.

As the first element 100 undergoes rotation relative to the second element 200, such as during one of the first movement and the second movement, the first relief portions 110 undergo circumferential or tangential displacement with respect to the electrical contact terminals 52, 53, 54. In practice, the leads 52, 53, 54 for electrical contact, and hence at least one electrical sensor 51, will be out of contact with respect to the conductive first relief portions 110. This results in a change in the electrical signal received from at least one electrical sensor 51 or received from at least one of the terminals 52, 53, 54 for contact.

In the example of FIG. 10 and 11, the recording device 50 is implemented as an increasing rotation detection device adapted to generate at least one electrical signal as the first relief portions 110 come into contact with the electrical contact leads 52, 53, 54 or when the first relief portions 110 come out of contact with terminals 52, 53, 54 for contact. In this case, several first relief parts 110 are simultaneously engaged with or disengaged from several contacts 52, 53, 54, thereby providing redundancy of the recording device 50. To register and/or measure the rotation of the first element 100 relative to the second element 200, it is sufficient to that at least one of the first relief portions 110 engages or disengages from at least one of the electrical contact terminals 52, 53, 54.

Of course, the number and arrangement of the first and second relief portions 110, 112, as well as the number and arrangement of the several contact leads 52, 53, 54 may vary. To increase the recording range or measuring range of the recording fixture 50, it may be advantageous that the pattern 104 comprising the first and second pattern portions 110, 112 is irregular when viewed in the circumferential or tangential direction. In practice, the circumferential or tangential dimension of the first and second portions of the relief may vary.

Several first relief portions 110 may also be provided that have a tangential extent or size that is different from the direction or tangential dimension of the other first relief portions 110. The same may be true for the second parts 112 relief. In addition, the circumferential or tangential distance between adjacent first relief portions and/or adjacent second relief portions may differ and may not be identical along the circumference of the tubular surface 102. Thus, a higher resolution of angular registration can be realized with a minimum of mutually interacting components on the first element 100 and the second element 200.

In FIG. 12 and 13 show in more detail a possible implementation of the recording device 150 in a pen-type injection device 1. The injection device 1 comprises a tubular-shaped body 10 with a tubular main body 201. The main body 201 is open in the proximal direction 3. The body 10 represents the second element 200 according to the present invention. The first element 100 has a tubular shape. It contains a tubular-shaped cylinder that is telescopically positioned within the second element 200. The first element 100 may be a metering or dialing cylinder. It can be rigidly and fixedly connected to the element 180 for the set. The housing 10 and hence the second element 200 is closed in the proximal direction 3 by a retaining cap 202 attached to the proximal end of the side wall of the second element 200.

Several orienting elements 160 are provided that are fixedly located on the inner surface of the side wall of the second element 200. As an example, the orienting elements 160 are implemented as electrical bridge contacts 162. They can be held in position at or on the inner surface of the second element 200 by means of a retaining cap 202. the cap has a central through hole through which the first element 100 is penetrated in the longitudinal direction. The first element 100, in particular its tubular cylinder, is rotatably attached to the kit element 180. It also engages in the axial direction with the element 180 for the set. It may be rigidly connected to the set member 180 such that any rotational and/or longitudinal sliding movement of the set member 180 is equally transmitted to the first member 100.

The dial member 180 includes an annular and radially expanding head section 184 that provides a hollow receptacle 185 for the recording device 150. The dial member 180 further comprises a longitudinally extending dial cylinder 182 rigidly connected to or integrally formed with the head section 184. The head section 184 forms the proximal end of the kit element 180. The outer circumference of the annular head section 184 has a diameter that may substantially correspond to the outer diameter of the second element 200. The head section 184 is open in the proximal 3 direction. can be attached to cover container 185.

Within the container 185 are the electronic components of the recording fixture 150. The recording fixture 150 includes a printed circuit board 190 on which the integrated circuit 192 is located. Typically, and as schematically illustrated in FIG. 18, the integrated circuit 192 includes at least a processor 191 and a memory 193 for at least temporarily storing data received or requested by the recording device 150. Optionally, the integrated circuit 192 is further equipped with a communication unit 195, typically implemented as a wireless communication unit, for establishing wireless signal transmission with an optional electronic device such as a portable electronic device such as a smartphone, tablet computer, or the like.

The recording fixture 150 further includes a battery 188. The battery may be mounted on one side of the printed circuit board 190, while the integrated circuit 192 is mounted on the opposite side of the printed circuit board 190. The integrated circuit 192 may be further coated with a coating 194. As illustrated in FIG. 12, a number of electrical contacts 186 are provided, which may be implemented as terminals, for example, made from sheet metal such as stainless steel. One end of the electrical terminals 186 is connected to the corresponding input terminals of the integrated circuit 192. The integrated circuit 192 may include multiple input terminals, thereby providing input channels for multiple electrical sensors or multiple leads for electrical sensor contact 151. The opposite end of the electrical contact may pass through the side wall or through the base of the dial element 180 and may be in contact with several parts 110, 112, 114 of the relief 104 of the first element 100. Electrical contacts 186 can only be permanently connected to one of the relief parts 110, 112, 114. During dose setting and/or during dose delivery, electrical contacts 186 may remain stationary with respect to several relief portions 110, 112, 114, as will be explained below.

Since any of the electrical contacts 186 is permanently connected to the input terminal of the integrated circuit 192 and additionally permanently connected to one particular part of the pattern 110, 112, 114 of the first element 100, the present recording device 150 need not be capable of reading a code printed or provided on the tubular surface. Instead, the electrical state and/or electrical properties of at least one of the plurality of relief portions 110, 112 undergo or undergo a change as the first element 100 undergoes at least one of a first movement and a second movement relative to the second element 200. Thus Thus, the electrical contacts 186 form or constitute the input of the recording device 150 and hence the integrated circuit 192, for example, implemented as a microcontroller, adapted for recording and for quantitative measurement or for determining the degree of rotation and/or longitudinal movement of the relief 104 relative to the landmark 160.

In FIG. 18 and 19 illustrate one example of a 2-bit angle encoder. Three separate orienting elements 160 are provided on or around the inner surface of the tubular shape of the second element 200. Each of the orienting elements 160 includes a bridge contact 162, 162', 162''. For example, the bridge contact 162 comprises a first contact lead 164 and a second contact lead 166 facing and pretensioned in the radial direction to come into mechanical contact with the relief portions 110, 112, 114 provided on the relief 104 of the tubular-shaped surface 102 of the first element 100 .

The first and second contact leads 164, 166 are separated from each other along the first separation direction D1. As illustrated in FIG. 18 and 19, the first separation direction D1 extends along a circumferential or tangential direction with respect to the tubular shape of the first member 100. The first contact terminal 164 and the second contact terminal 166 may be spaced apart at a predetermined angle, such as approximately 60°. Each of the first and second parts 110, 112 relief contains a longitudinal strip. The first relief part 110 is a strip with a width of 30°. The first relief portion 110 is electrically conductive. The second relief part 112, which is electrically insulating, is located tangentially adjacent to the first relief part 110. The first relief portion 110 has an angular or tangent width of about 15° to about 30°. Additionally, a third pattern portion 114 is provided, also implemented as an electrically conductive pattern portion. The third relief portion 114 also includes a longitudinal strip and has a tangential or circumferential width of from about 105° to about 120°.

As seen along the first separation direction D1 or as seen along the tangential direction, the first relief portion 110 is followed by the second relief portion 112. The second relief part 112 is followed by the third relief part 114 . The third relief part 114 is followed by an additional second relief part 112 . The additional second relief part 112 is followed by the additional first relief part 110'. The additional first relief portion 110' is followed by another second relief portion 112, and the corresponding second relief portion 112 is finally followed by an additional third relief portion 114. This third relief portion 114 is again followed by a second relief portion 112 .

As illustrated in FIG. 19, the first relief portions 110, 110' and the third relief portions 114 are separated from each other by a second relief portion 112. The first parts 110, 110' of the relief are surrounded in both directions tangentially by the second part 112 of the relief. Also, the third relief portions 114 are surrounded in a tangential direction by respective second relief portions 112.

The first pattern parts 110, 110' are permanently electrically connected to the input terminals of the recording device 150. In this case, the pattern part 110' is connected to the first input 152 of the recording device 150. The additional first pattern part 110 is connected to the second input 154 of the recording device 150. The third parts 114 reliefs are electrically connected to the supply voltage 156. They can be mutually electrically interconnected. They may be provided with a predetermined DC voltage level as the first element 100 undergoes rotation relative to the second element 200.

As illustrated in FIG. 18, a plurality of bridge contacts 162, 162', 162'' are equally spaced around the circumference of the first element 100.

As the first element 100 undergoes rotation relative to the second element and as the relief 104 rotates relative to the landmark 160, a rotational 2-bit Gray code may be recorded at the first and second input terminals of the recorder.

In the pivot position, as illustrated in FIG. 18, only the first relief portion 110' is electrically connected to one of the third relief portions 114 via bridge contact 162. The other relief portion 110 is disconnected from the relief portions 114. Therefore, a logic 1 is provided at the first input terminal 152. As the first element 100 and the relief 104 now rotate clockwise relative to the landmark 160, the contact pin 164 loses electrical contact with the first relief portion 110'. This results in a logic 0 at the first input terminal 152. In both configurations, the second input terminal 154, and hence the other relief portion 110 illustrated at the bottom of FIG. 18 is not in electrical contact with the additional bridge contacts 162', 162''.

Accordingly, the second input terminal 154 will remain at logic 0 until the first element 100 rotates further in the clockwise direction. Then, the first contact pin 164 of the bridge contact 162'' will make electrical contact with the first relief portion 110, thereby generating a logic 1 at the second input terminal 154 while the first input terminal 152 remains at a logic 0. This is because the other and therefore the second terminal 166 for the contact of the bridge contact 162'' is and remains in contact with the third part 114 of the relief.

As the first member 100 rotates further in the clockwise direction, the first contact pin 164 of the bridge contact 162 comes into contact with the third relief portion 114 and the second contact pin 166 of the bridge contact 162 will come into contact with the first portion 110' relief. This will generate a logic 1 also at the first input terminal 152. Thereafter, and as the first element 100 rotates further in a clockwise direction relative to the second element 200 and therefore relative to the reference element 160, the bridge contact 162'' will lose contact with the relief portion 110 due to the generation of a logic 0 at the second input terminal. Thus, a 2-bit Gray code of 01, 00, 10, 11 can be generated as the first element 100 rotates clockwise relative to the second element 200 by 60°. Thus, 24 discrete angular positions of the first element 100 relative to the second element 200 can be electronically recorded. With the implementation of the 2-bit Gray code, not only the amount of relative rotation, but also the direction of rotation can be accurately determined. The implementation of the 2-bit Gray code requires the recording device 150 to count the signal change at the first and second input terminals 152, 154.

In the implementation described herein, the relative rotation step size between the first element 100 and the second element 200 is approximately 15°.

The angular width of the first and therefore electrically conductive relief parts 110, 110' is twice the pitch size. The angular width of the second and electrically insulating relief portions 112 is substantially equal to or substantially twice the pitch size. The angular position of the first relief part 110 and the additional first relief part 110' is six times the step size. Therefore, the angular shift between the first relief portion 110 and the additional first relief portion 110' in one direction is 165°. The angular distance between the first relief part 110 and the additional first relief part 110' is 135° in one direction and 165° in the other direction.

Another example of a 3-bit Gray code implementation is shown in FIG. 20 and 21. Here, the relief 104 comprises a striped relief 124 with several longitudinal strips 126 comprising six equidistant conductive relief portions 110, 114, 110', 114, 110'', 114 and corresponding six insulating relief portions 112, located between them. As illustrated in FIG. 21 and along the first separation direction D1, the first relief portion 110 is followed by the second relief portion 112. The second relief part 112 is followed by the third relief part 114 . The third relief part is again followed by an additional second relief part 112 . This additional relief portion is again followed by the first relief portion 110', and so on. Each relief portion 110, 112, 114 has a substantially identical extension along the first separation direction D1. In this case, each relief portion 110, 112, 114 has an extension of approximately 30°.

The orienting element 160 includes two bridge contacts 162, as described above in connection with FIG. 18. Each of the bridge contacts 162 includes a first contact lead 164 and a second contact lead 166. The first and second contact leads 164, 166 are separated by an angular distance of approximately 50°. There is an angular shift between the first bridge contact 162 and the second bridge contact 162' of approximately 135°. Therefore, the shortest angular distance between the second contact terminal 166 of the first bridge contact 162 and the first contact terminal 164 of the second bridge contact 162' is approximately 85°. Therefore, the two bridge contacts 162, 162' are spaced apart by 2.25 times the width of the strips 126.

Three relief portions 114 are provided that are permanently connected to a voltage source. The first three relief portions 110, 110', 110'' are permanently connected to the first input terminal, the second input terminal, and the third input terminal of the recording device 150, respectively. In particular, the first relief portion 110 is permanently electrically connected to the first input terminal. The additional first relief part 110' is permanently electrically connected to the second input terminal, and the additional first relief part 110'' is permanently electrically connected to the third input terminal.

In the configuration of striped relief 124 and orienting element 160, as illustrated in FIG. 20 and 21, the following 3-bit cyclic Gray code can be implemented, with individual doses having an angular shift of 15°.

Number of collected doses (U) 1 ^-I input terminal 2 ^-I input terminal 3 ^-I input terminal 0 0 0 0 1 0 1 0 2 1 1 0 3 1 0 0 4 0 0 0 5 0 1 0 6 1 1 0 7 1 0 0 8 0 0 0 9 0 0 1 10 0 1 1 eleven 0 1 0 12 0 0 0 13 0 0 1 14 0 1 1 15 0 1 0 16 0 0 0 17 1 0 0 18 1 0 1 19 0 0 1 20 0 0 0 21 1 0 0 22 1 0 1 23 0 0 1 24 0 0 0

The cyclic Gray code illustrated above allows determining the number of units dialed and determining the direction of rotation of the first element 100 relative to the second element 200. In addition, checking the degree of error is also possible if certain states cannot be reached.

The first element 100 rotates relative to the second element 200 only during one of the first movement and the second movement. For example, the first element 100 rotates relative to the second element 200 only during and to set the dose. During or for dispensing or releasing a dose of a drug, there may be no relative rotation between the first element 100 and the second element 200. During such longitudinal sliding movement without rotation, the longitudinal stripe pattern 124 may not generate an electrical signal.

To record the completion of the dose delivery procedure, the pattern 104 may be divided into a first pattern section 120 and a second pattern section 122, which are separated from each other along the longitudinal direction of the first element 100. In FIG. 22 and 23 schematically illustrate such a longitudinal separation, generally along the second separation direction D2. In this case, the first relief portion 120 may comprise a striped relief 124 as illustrated and described above in connection with FIG. 18-21. The striped pattern 125 comprises several pattern portions 110, 112, 114 as described above. Orienting element 160 may include a bridge contact 162 having at least a first terminal 164 for electrical contact and a second terminal 166 for contact.

As described above, the third part 114 relief can be permanently connected to the source 156 voltage. In the configuration as shown in FIG. 22, the first pattern portion 110, i.e., the conductive pattern portion, is electrically connected to the third pattern portion 114 via a bridge contact 162. In this case, the bridge contact 162 comprises a third contact terminal 168 that is separated from at least one of the first terminal 164. for contact and the second terminal 166 for contact along the second separation direction D2. The second separation direction D2 does not run parallel to the first separation direction D1. The second separation direction D2 extends at a predetermined angle relative to the first separation direction D1. Typically, and during a non-rotating longitudinal sliding movement between the first element 100 and the second element 200, the relief 104 undergoes a sliding movement relative to the reference element 160 along the second separation direction. In the configuration as illustrated in FIG. 22, the third contact terminal 168 is located on or in the first relief section 120.

The first section 120 relief is located in the longitudinal direction adjacent to the second section 122 relief. The first relief section 120 and the second relief section 122 are separated from each other by a separation 121, which may be implemented as a separation line. Separation 121 distinguishes with respect to electrical conductivity and/or with respect to electrical state from at least one of the first section 120 of the relief and the second section 122 of the relief.

The second section 122 of the relief contains the fourth part 116 of the relief. The fourth pattern portion 116 is also a conductive pattern and is permanently connected to the recording device 150 via at least one electrical contact 186 as described in connection with FIG. 12 and 13. In the configuration as illustrated in FIG. 22, the second relief portion 122 separated from the first relief portion 120 along the second separation direction D2 is not in contact with the third contact lead 168. As the first element 100, and hence the relief 104, undergoes further sliding along the second separation direction D2, for example, at the very end of the dosing procedure, the third contact lead 168 crosses the separation 121 and comes into electrical contact with the fourth relief portion 116 .

At the same time, the bridge contact 162 is and remains in electrical contact with the third relief portion 114. Thus, an electrically conductive connection is formed between the third pattern portion 114 and the fourth pattern portion 116 when the first feature 100 reaches a predetermined longitudinal position with respect to the second feature 200. For example, the fourth pattern portion 116 can be provided with an appropriate supply voltage when the configuration is reached, as illustrated in fig. 23, typically at the end of the dose delivery procedure, and also when the first element returns to its original state relative to the second element 200.

Crossing the separation 121 and making electrical contact between the fourth pattern portion 116 and the third pattern portion 114 may be recorded by the recording device 150. When electrical contact is established, the recording device 150 records that the zero dose configuration or the end of the dose delivery procedure has been reached. Thus, there will be no need for an additional recording device or switch to register, in particular, the longitudinal position of the first element 100 relative to the second element 200. Longitudinal displacement and registration of at least one particular longitudinal position of the first element 100 relative to the second element 200 can be easily implemented in the recording device 150 only by providing an additional electrically conductive part 116 of the relief on the relief 104 and by providing an additional terminal 168 for contact on the bridge contact 162, while the additional, and therefore the third contact terminal 168 is separated from at least one of the additional terminals 164, 166 to engage along a second separation direction D2, which may be somewhat parallel to the sliding direction between the first element 100 and the second element 200.

In FIG. 28 illustrates a more detailed implementation of relief 104 comprising a first longitudinal relief section 120 and a second longitudinal relief section 122. In principle, relief 104, as illustrated in FIG. 28 is very similar to relief 104 as illustrated in FIG. 19. Two thirds of the relief sections 114 are provided that are permanently connected to the voltage source V ₀ via an electrical contact 186. At the longitudinal end of the first section 120 of the relief, facing away from the second section 122 of the relief, two thirds of the relief sections 114 are mutually interconnected. At a longitudinal distance from this longitudinal end, two thirds of the relief portions 114 are separated from each other by an angular distance of approximately 75°. In this corner section, one first relief portion 110' is provided electrically insulated from the third relief portions 114 by insulating relief portions 112.

A small but distinct insulating longitudinal gap is provided between the longitudinal end of the first relief portion 110' and the interconnection between the two third relief portions 114. The electrically conductive first pattern portion 110' extends longitudinally along nearly the entire first pattern section 120 and intersects the second pattern section 122. It is electrically isolated from the additional relief portions 116 provided in the second relief section 122. The longitudinal end of the first relief portion 110', which is located in the second relief section 122, is electrically connected to the first input terminal 152 of the recording device 150. The other first relief portion 110 comprises an elongated strip 126 that has a shape substantially identical to the relief portion 110'. This relief portion 110 is connected via an electrical contact 186 to the second input terminal 154. Also, this additional first relief portion 110 extends almost the entire length of the first relief section 120 and the second relief section 122.

Only one of the third parts 114 of the relief runs in the longitudinal direction through the entire second section 122 of the relief. Here, the longitudinal end of the third relief portion 114 located in or on the second relief section 122 is connected to an electrical contact 186 and hence to a voltage source.

The shape, position, and angular separation of the several relief portions 110, 110', 112, and 114 of the first relief section 120 strongly resemble relief 104, as illustrated in FIG. 9 and provide 2-bit quadrature coding. In the second relief section 122, the angular width of the third relief portion 114 is reduced to 30°. Intermediate spaces in the second relief section 122 between the first relief portions 110, 110' and the third relief portion 114 are substantially filled with fourth relief portions 116. The fourth relief portions 116 may be electrically interconnected. Each of the fourth relief portions 116 is connected to an electrical contact 186. Each electrical contact may be connected to the zero dose input terminal Z of the recording device 150.

The principle of operation of this 2-bit coding with auxiliary registration of the zero dose position is illustrated in FIG. 14-17 and with respect to FIGS. 24-26. The bridge contact 162 is rigidly connected to the main body 201 of the tubular shape of the second member 200, as illustrated in FIG. 27. It is located on the inner side wall of the tubular shape of the body of the injection device 1. As illustrated in more detail in FIG. 26, bridge contact 162 has three terminals 164, 166, 168 for contact. The bridge contact 162 further comprises three flexible tabs 163, 165, 167. The contact leads 164, 166, 168 are located at the longitudinal and hence the free end of the respective flexible tabs 163, 165, 167. All tabs 163, 165, 167, and also the respective terminals 164, 166, 168 for the contact are electrically interconnected. Bridge contact 162 may include a piece of sheet metal.

As schematically illustrated and mentioned above, the first contact terminal 164 and the second contact terminal 166 are separated from each other along the first separation direction D1. The first separation direction D1 may coincide with the tangential direction or the circumferential direction of the tubular relief 104 . The first and second contact leads 164, 166 may be located in the same longitudinal position. The third terminal 168 for contact is located at a longitudinal distance from at least one of the first and second conclusions 164, 166 for contact. It is generally longitudinally separated along the second separation direction D2 from both the first and second contact leads 164, 166.

The contact leads 164, 166, 168 are integrally formed in the flexible tabs 163, 165, 167. Each of them may comprise embossed portions protruding radially inwards. The contact leads 164, 166, 168 may comprise a semi-dome shaped structure and may thus protrude radially inward from the rather flat surface of the flexible tabs 163, 165, 167. , good and reliable mechanical and hence electrical contact between the contact terminals 164, 166, 168 and electrically conductive structures can be ensured, hence with several parts 110, 114, 116 of the relief 104 of the first element 100. Typically, the flexible tabs 163, 165, 167 and the radial protrusion of the respective contact leads 164, 166, 168 provide a kind of radial preload when the first element 100 is located inside the hollow second element 200 tubular shape.

Comparison of FIG. 24 and 25 show the function of the third pin 168 for the contact. In FIG. 24, the first element 100 is subjected to a distally directed, non-rotating sliding motion relative to the second element 200 and therefore to the plurality of bridge contacts 162, 162'. In the configuration of FIG. 24, the first element 100 is located close to the zero dose position, but has not yet reached that zero dose position. In this case, the first relief portion 110 is in electrical contact with the third relief portion 114 via bridge contact 162. In this configuration, the third contact terminal 168 is located in the first relief section 120. Therefore, it is located distal to division 121.

Further, and as the first element 100 approaches and reaches the zero dose configuration with respect to the second element 200 and hence with respect to the reference element 160, as illustrated in FIG. 25, the third contact terminal 168 crosses the separation 121 and comes into electrical contact with the fourth pattern portion 116, while the first contact terminal 164 remains in electrical contact with the third pattern portion 114. Thus, the supply voltage present in the third relief portion 114 is also provided for the fourth relief portion 116 . As shown in FIG. 28, the Z input terminal of the recording device 150 is then connected to the supply voltage and switches from logic 0 to logic 1, since the zero dose configuration, as illustrated in FIG. 26, has been reached. Thus, the position of the zero dose of the first element 100 relative to the second element 200 can be accurately recorded at the end of the dose delivery procedure.

In FIG. 29-37 schematically illustrate another example of a recording device 50. Also in this case, the first element 100 includes a dial element 180 or a dial cap comprising a radially expanding head section 184 with an annular outer gripping surface. The set element 180 further comprises a longitudinally extending set cylinder 182 rigidly connected to or integrally formed with the head section 184.

The first element 100 has a high degree of similarity compared to the examples described above. The first tubular shaped element 100 comprises a tubular shaped surface 102 which is effectively an outer surface 106. A relief 104 is provided on the outer surface. The relief 104 comprises a first relief section 120 and a second relief section 122. The first relief section 120 extends along nearly the entire longitudinal extension of the recruitment cylinder 182. The second relief section 122 is located at or near the distal end of the first element 100 and therefore at the distal end of the dial cylinder 182. The relief 104 contains several relief parts 110, 112. The relief portions 110 are electrically conductive. The relief portions 112 are electrically insulating. Additionally, a fourth relief part 116 is provided, which is located exclusively in the second relief section 122. Parts 110, 112 relief have an oblong shape. They form a striped relief 124 containing several oblong or rectangular strips 126.

The recording device 50 includes at least one electrical sensor 51 which is located on the second element 200, which is not specifically illustrated in the sequence of FIG. 29-37. At least one electrical sensor 51 comprises or forms at least one orienting element 60. At least one electrical sensor 51 is attached and/or non-movably positioned on the inwardly facing surface of the second element 200.

As illustrated in FIG. 29, at least one electrical sensor 51 has three terminals 52, 53, 54 for electrical contact. Conclusions 52, 53, 54 for contact are located in the same longitudinal position. They are separated along the first separation direction D1, hence along the tangential direction of the tubular shape of the surface 102. rotation relative to the orientation element 60, therefore, as the first element 100 rotates relative to the second element 200. The distance and/or separation between adjacent terminals 52, 53, 54 for contact along the first separation direction D1 is generally less than the width of the electrically conductive parts 110 relief in the corresponding separation direction D1.

It is even possible that the total separation of the two outer contact leads 52, 53 along the first separation direction D1 is less than the corresponding width of the first relief portion 110.

In FIG. 30 schematically illustrates one example of an electrical circuit showing three terminals 52, 53, 54 for a contact. Each of the two outer pins 52, 54 for a contact can be permanently connected to a corresponding input terminal A, B of the sensor array 50. These two contact terminals 52, 54 can be connected to a voltage source V ₀ via respective resistors R _A and R _B . An additional pin 53 for the contact can be connected to ground. Resistors can be thought of as pull-up resistors. In the sequence of FIG. 31-34 illustrate several rotational states of the terrain 104 relative to the landmark 60.

In this case, the position of the pin 52 is represented as A, the position of the pin 53 is represented as G, and the position of the pin 54 is represented as B. In the configuration as illustrated in FIG. 31, all three contact terminals are electrically connected to each other via the electrically conductive pattern portion 110. As the pattern 104 undergoes rotation, only one of the contact leads, namely the contact lead 54, comes out of contact with respect to the electrically conductive portion 110 of the pattern. As illustrated in FIG. 32, contact terminal 54, and therefore contact B, is electrically connected to the insulating pattern portion 112. As a consequence, the contact pin 54 is no longer connected to the contact pin 53 and therefore no longer connected to ground. As a result, the corresponding input terminal B of the recording device 50 switches to logic 1, while the other input terminal A, connected to the contact terminal 52, remains at logic 0.

As the relief 104 rotates further in the same direction, both the contact terminal 54 and the contact terminal 53 are electrically isolated as they are both electrically connected to the insulating portion 112 of the relief. For this, it is only important that the contact terminal 53, and hence the contact terminal 53 connected to earth, be electrically isolated from the other two contact terminals. Accordingly, both input terminals A and B are at logic 1, as illustrated in FIG. 33. As further illustrated in FIG. 34, when the relief 104 rotates further, both contact leads 53 and 54 are electrically connected via the additional conductive portion 110' of the relief. Accordingly, the input terminal B switches to logic 0, while the input terminal A is electrically connected to the insulating relief portion 112. Accordingly, the corresponding input voltage can be measured at the input terminal of the recorder 50.

The angular width or tangential extension of the conductive relief portions 110, 110' may be equal to or may be in the range of 45°. The corresponding extension or size of the insulating relief portion 112 is substantially smaller than the extension or width of the first relief portion 110, 110'. The extension or size of the first relief part 110, 110' may be three times the corresponding width or size of the second relief part 110 along the first separation direction D1. The angular width of the second relief portion 110 may be approximately 15°. Thus, a binary incremental encoder can be realized. Since the striped pattern 124 extends in the longitudinal direction, it does not change with respect to the longitudinal displacement of the first element 100 relative to the second element 200.

In FIG. 35 and 36 schematically illustrate another recording device 50. In this case, at least one electrical sensor 51 includes a switch 55 that is adapted to mechanically engage with at least one of the radial recess, recess, or radial protrusion of the first element 100. In this case, and as illustrated in FIG. 35 and 36, the first element 100 includes a radially stepped portion 181 longitudinally adjacent to the dial cylinder 182. The stepped portion 181 forms a constriction of the radially expanding head section 184. The switch 55 protrudes axially from the main portion 201 of the second element 200. It extends in the proximal direction 3 and is configured to engage with the stepped portion 181 when the first element 100 and hence 180 for the set returns to the zero dose or end dose configuration as illustrated in FIG. 36.

The radial position of the switch 55 overlaps with the radial position of the stepped portion 181. When the set element 180 and when the first element 100 are reset, as illustrated in FIG. 36, the switch 55 is pressed in the distal direction 2. When the electromechanical switch 55 is pressed at the end of the dosing procedure, a corresponding electrical signal is generated that can be processed by the recording device 50, which is located on the second element 200 or built into it.

Alternatively, or in addition to the electromechanically implemented switch 55, a second relief section 122 may be provided at the longitudinal or distal end of the first element 100, as illustrated in FIG. 37. There, the fourth conductive pattern section 116 has an annular shape and is separated in the longitudinal direction from the striped pattern 124, which is located exclusively in the first pattern section 120.

The electrical sensor 51, and hence the orientation member 60, located and placed on the second member 200, comprises two contact leads 52, 53 which are located in the same longitudinal position at a predetermined distance in the tangential direction. When the first element 100 approaches and reaches the end-of-dose or zero-dose configuration, as illustrated in FIG. 36, the contact leads 52, 53 overlap with the fourth conductive pattern portion 116. In fact, the two terminals 52, 53 for contact become electrically connected through the fourth part 116 of the relief. Because of this, the electrical circuit including the two contact terminals 52, 53 is closed by the relief portion 116, and a corresponding electrical signal is generated.

In FIG. 38 illustrates another example of a pattern 104. In this case, the pattern 104 includes a pattern in a longitudinally extending strip, in which the first and second portions 110, 112 of the pattern are arranged in alternation along the circumference or tangential direction of the first element 100 tubular shape. In this case, the first relief portion 110 comprises a radially raised, and therefore radially outwardly projecting, longitudinally extending rib or ridge 130. The second relief portion 112 comprises a corresponding radial recess or groove 132.

To implement binary coding, at least two electromechanically implemented switches 56, 57 are provided, which can be preloaded in the radial direction. Switches 56, 57 are electrically connected to at least one electrical sensor 51. Switches 56, 57 are activated and/or deactivated when the raised ridges 130 and/or grooves 132 are rotated in the tangential or circumferential direction.

Also illustrated is an axial or longitudinally acting switch 55 that can be depressed by means of a stepped portion 181 at the distal end of the head section 184 of the dial member 180, as described above in connection with FIG. 35 and 36.

In FIG. 39-41 schematically illustrate another example of the arrangement of five contact leads forming the orientation element 60. In this case, a 5-bit absolute code can be provided, with each of the 24 rotational positions of the first element 100 relative to the second element 200 being uniquely determined.

The relief 104 illustrated in FIG. 40 and 41 is again a striped pattern 124 comprising several first pattern portions 110 that are electrically conductive and several pattern portions 112 that are electrically insulating. Unlike the examples described above, all of the electrically conductive pattern portions 110 are electrically connected via an annular-shaped pattern connecting portion 111 at the proximal or distal end of the pattern 104.

Several contact leads 52, 53, 54 and two additional contact leads illustrated in FIG. 39 are located at positions 0°, 60°, 135°, 225°, and 300° along the inner circumference of the second element 200. The pattern 104 can be characterized as a binary pattern, with zero representing a 12° extension of the electrically insulating second portion 112 of the pattern, and the logical 1 represents a 15° tangential extension of the electrically conductive first pattern portion 110. In this case, for a given arrangement and distribution of the five pins 52, 53, 54, as illustrated in FIG. 39, the code, and therefore the pattern 104, may have the following structure: 0000011100001110111000011. Therefore, the original non-conductive pattern portion 112 extends 75° in the tangential direction, followed by a 45° wide conductive pattern portion 110, followed by the insulating pattern portion 112 60° wide, followed by a 45° wide conductive pattern portion 110, followed by a 15° wide insulating pattern portion 112, followed by an additional 45° wide conductive pattern portion 110, followed by a 45° wide insulating pattern portion 112, and , finally followed by a conductive part of the relief 30° wide.

This code, combined with the location of the five pins 52, 53, 54 for the electrical sensor contact 51, provides an absolute code with 24 unique positions. Based on the fact that the first element can be rotated a little more than three times, 80 possible rotation positions are available during dialing, with the corresponding rotation positions being deduced from the sequence in which the codes appear to yield an almost absolute coding solution for all dialed doses. Moreover, because of the unique code for each achievable rotational position of the first element 100 relative to the second element, an error control algorithm can be applied when decoding the signal from the multiple pins 52, 53, 54 for a contact. For example, it is possible to go directly from the 2 1s position to the 23 1s position, whereby if a "23 1s" code is observed while dialing between 2 1s and 3 1s, it will be obvious that this is a transmission artifact and will not be taken into account.

At the zero dose position, therefore, at the end of the dose delivery procedure, and when the first element 100 assumes the most distal position relative to the second element 200 at the end of the dose delivery procedure, all five contact leads 52, 53, 54 will be in contact with the connecting portion 111 of the relief on the proximal end of the first element 100. This is recorded as a unique code representing 11111, which can be decoded by the electronics of the recording device 50 to indicate the end for zero dose position units. The example illustrated in FIG. 39-41 provides an increased level of reliability compared to incremental dose counting systems.

In all of the examples described above, the use of electrical contact leads or switches allows the recording device 50, 150 to have low power consumption and eliminates the need to separately register a mode change when issued by the device, since the device can remain on during its lifetime. This low power consumption, combined with the use of, for example, near-field communication technology for communication unit 195, allows the use of a small battery and simpler microcontroller implementations, making the example suitable for incorporation into a pen-type disposable injection device.

The recording device 50, 150, as described herein, can be implemented and built into the disposable injection device 1. The recording device 50, 150 can remain on during its lifetime. It can remain inactive by default. The integrated circuit, and hence the microcontroller of the recording device 50, 150, can wake up from the inactive state at the first change in the electrical sensor 51, 151, which is observed when the first element 100 is subjected to movement relative to the second element 200 for the first time.

The conductive pattern 104, and in particular the electrically conductive pattern portions 110, 114, 116, can be realized by using carbon-based conductive paints to create a pattern 104 on the surface 102 of the tubular shape. Such carbon-based inks are available at low cost and are suitable for rotary pad printing applications in combination with appropriate thinners. Rotary pad printing is a high-volume manufacturing process. Moreover, in order to reduce the electrical resistance of the conductive paint, carbon-based paints can be mixed with silver-based paints that are miscible with them. Additionally, curing agents designed specifically to improve the mechanical properties of the paint under sliding contact can be added to the paint to increase wear resistance.

An optimized combination of carbon-based paint, thinners to lower viscosity, conductive additives such as silver to reduce electrical resistance, and hardeners to reduce mechanical wear are possible in the above examples to achieve all of the desired properties.

Because the first element 100 only undergoes a rotational or helical movement relative to the second element 200 during one of the first movement and the second movement, such as only during dose setting, the angular position of the first element relative to the second element at the end of successive dose delivery procedures changes each time the dose dialing element 180 undergoes a non-integer rotation relative to the second element 200. As a result, the position of the electrical contact terminals 52, 53, 54, 164, 166, 168 relative to the relief 104 undergoes regular changes, which essentially reduces mechanical wear and tear, when the relief 106 is subject to movement relative to the contacts 52, 53, 54, 164, 166, 168.

To reduce abrasion and/or wear of the electrically conductive pattern 104, the second element 200 may be equipped with at least one cleaning pad 210 located at a distance from at least one of the conclusions 52, 53, 54, 164, 166, 168 for electrical contact along the at least one of the direction of the first movement and the second movement. In FIG. 42 illustrates such an example. Contact lead 164 located on second member 200 is assigned at least one cleaning pad 210, 211, 212, 213. Cleaning pads 210, 211 are longitudinally divided relative to contact lead 164. The cleaning pads 210, 211 are located in the same tangential position as the contact lead 164. When the first element 100, for example, is subjected to longitudinal sliding displacement without rotation relative to the second element 200 in the distal direction, the cleaning pad 211 is designed to clean the relief 104 before it comes into electrical contact with the contact lead 164. When the first element 100 is subjected to sliding movement without rotation in the proximal direction, the cleaning pad 210, located proximal to the lead 164 for electrical contact, provides an appropriate cleaning of the electrically conductive pattern 104.

The same is true for additional cleaning pads 212, 213, which are located along the helical guide, which corresponds to the helical movement of the first element 100 relative to the second element, for example, during dose setting. In this case, the contact lead 213 is offset tangentially and longitudinally from the contact lead 164 in the proximal direction. The other terminal 212 for contact is located with a longitudinal distal shift and with a given tangential shift in accordance with the pitch of helical movement between the first element 100 and the second element 200.

As further shown in the cross section illustrated in FIG. 43, the cleaning pads 212, 213 may be capable of at least one of elastic deformation or rotation about the longitudinal direction as a deformation axis or a rotation axis. The cleaning pads 212, 213 may be resiliently deformable like a windshield wiper. When the first element 100, for example, rotates clockwise relative to the second element 200, the contact surface between the cleaning pad 212, 213 may increase due to elastic deformation of the radially protruding pointed tip of the cleaning pad 212, 213, or due to a corresponding rocking or inclined movements of the corresponding output 212, 213 for contact.

Reference positions

1 injection device

2 distal direction

3 proximal direction

3 proximal direction

4 direction of dose increase

5 direction of dose reduction

6 cartridge

7 cork

8 gear

10 building

11 trigger element

12 item to set

13 dosing window

14 cartridge holder

15 injection needle

16 inner needle cap

17 outer needle cap

18 protective cap

20 piston rod

25 capsule

26 seal

28 nest

50 recording device

51 electrical sensors

52 contact pin

53 pin for contact

54 pin for contact

55 switch

56 switch

57 switch

60 reference element

100 first element

102 tubular surface

104 relief

106 outer surface

110 part of the relief

111 connecting part of the relief

112 part of the relief

114 part of the relief

116 part of the relief

120 relief section

121 division

122 relief section

124 embossed stripes

126 strip

130 comb

132 groove

150 recording device

151 electrical sensor

152 input terminal

154 input terminal

156 supply voltage

160 reference element

161 main parts

162 bridge contact

163 foot

164 pin for contact

165 foot

166 pin for contact

167 foot

168 pin for contact

180 item to set

181 step part

182 dial cylinder

184 head section

185 receptacle

186 electrical contact

187 side wall

188 battery

190 PCB

191 processors

192 integrated circuit

193 storage device

194 coverage

195 communication block

196 closing agent

200 second element

201 tubular body

202 holding cap

210 cleaning pad

211 cleaning pad

212 cleaning pad

213 cleaning pad

Claims (20)

1. An injection device for setting and administering pre-set or user-selectable doses of a drug, the injection device comprising: - an elongated body (10) defining the longitudinal direction (z) and configured to receive a cartridge (20) containing a drug, - a recording device (50) adapted to register the relative movement between the first element (100) and the second element (200), wherein the first element (100) undergoes a first movement relative to the second element (200) along the first longitudinal direction (3) to set the dose , and moreover, the first element (100) undergoes a second movement relative to the second element (200) along the second longitudinal direction (2) for dispensing a dose, and wherein one of the first movement and the second movement is a helical movement, and the other of the first movement and the second movement is a sliding movement in the longitudinal direction (z), - moreover, the second element (200) contains at least one orientation element (60; 160) attached to the second element (200), - moreover, the first element (100) contains a surface (102) of a tubular shape, equipped with a relief (104) facing the orientation element (60; 160), - moreover, the recording device (50; 150) contains at least one electrical sensor (51; 151) located on one of the first element (100) and the second element (200) and adapted to register changes in the position of the relief (104) relative to at least at least one orientation element (60; 160) and for generating at least one electrical signal in response to a change in the position of the relief (104) during at least one of the first movement and the second movement of the first element (100) relative to the second element (200) . 2. The injection device according to claim. 1, characterized in that the relief (104) contains at least the first part (110) of the relief and the second part (112) of the relief, not overlapping with the first part (110) of the relief, and the first part ( 110) of the relief and the second part (112) of the relief differ in at least one of the following parameters: electrical conductivity, optical transparency, optical reflectivity, magnetic susceptibility, electrical susceptibility and radial position relative to the central axis of the surface (102) of a tubular shape. 3. Injection device according to any one of the preceding claims, characterized in that the longitudinal extension of the relief (104) is equal to or greater than the maximum longitudinal displacement of the first element (100) relative to the second element (200). 4. An injection device according to any one of the preceding claims, characterized in that the relief (104) comprises a first relief section (120) and a second relief section (122), wherein the first relief section (120) and the second relief section (122) are located without overlapping on the surface (102) of a tubular shape, and moreover, the second section (122) of the relief is separated from the first section (120) of the relief in the longitudinal direction (z). 5. Injection device according to claim 4, characterized in that the first section (120) of the relief contains a relief (124) in a strip containing several parallel oriented longitudinal strips (126), with the longitudinal strips (126) running parallel to the longitudinal direction (z) , or wherein the longitudinal strips (126) extend at a predetermined angle relative to the longitudinal direction (z). 6. Injection device according to claim 4 or 5, characterized in that the recording device (50; 150) is adapted to register the longitudinal overlap of the reference element (60; 160) with at least one of the first relief section (120) and the second section ( 122) of the relief, regardless of the rotational state of the first element (100) relative to the second element (200). 7. Injection device according to any one of the preceding claims, characterized in that the pattern (104) comprises at least a first pattern part (110) which is electrically conductive and at least a second pattern part (112) which is electrically insulating. 8. Injection device according to claim 7, characterized in that the recording device (50; 150) contains at least one output (52, 53, 54; 164, 166, 168) for electrical contact located on the second element (200) and adapted to alternately connect with the first relief part (110) and the second relief part (112) representing the relief (104) when the first element (100) undergoes one of the first movement and the second movement relative to the second element (200). 9. Injection device according to claim. 7 or 8, characterized in that the relief (104) contains at least a third part (114) of the relief, which is electrically conductive, and the first part (110) of the relief and the third part (114) of the relief are electrically separated . 10. The injection device according to claim 9, characterized in that the recording device (150) and at least one electrical sensor (151) are located on the first element (100), and at least one electrical sensor (151) is electrically connected to the first part (110) of the relief, and moreover, at least one orienting element (160) is located on the second element (200) and contains an electrical bridge contact (162) configured to alternately establish and interrupt electrical contact between the first part (110) of the relief and the third part (114) of the relief, when the first element (104) is subjected to one of the first movement and the second movement relative to the second element (200). 11. The injection device according to claim 10, characterized in that the electrical bridge contact (162) comprises a first terminal (164) for electrical contact and a second terminal (166) for electrical contact, wherein the first terminal (164) for electrical contact and the second terminal (166) for electrical contact are electrically connected, and wherein the first terminal (164) for electrical contact and the second terminal (166) for electrical contact are spatially separated from each other along the first separation direction (D1) parallel to the distance between the first part (110) of the relief and the third part (114) of the relief. 12. The injection device according to claim. 11, characterized in that the electrical bridge contact (162) contains a third output (168) for electrical contact, spatially separated from at least one of the first output (164) for electrical contact and the second output (166 ) for electrical contact along the second separation direction (D2) which is not parallel to the first separation direction (D1). 13. Injection device according to any one of paragraphs. 10-12, characterized in that the electrical bridge contact (162) contains a main part (161) made of sheet metal and containing at least one flexible tab (163, 165, 167), with at least one of the first output ( 164) for electrical contact and a second output (166) for electrical contact is located at the free end of at least one flexible tab (163, 155, 167). 14. Injection device according to any one of paragraphs. 8-13, characterized in that it additionally contains at least one cleaning pad (210, 211, 212, 213) located on the second element (200) or in it at a distance from at least one output (52, 53, 54 ; 164, 166, 168) for electrical contact along at least one of the first movement and the second movement. 15. Injection device according to any one of paragraphs. 10-13, characterized in that the length of the longitudinal movement of the first element (100) relative to the second element (200) during the first movement is identical to the length of the longitudinal movement of the first element (100) relative to the second element (200) during the second movement, and moreover, at least at least one of the terminals (164, 166, 168) for contact is in the first rotational position relative to the relief (104), before the first element (100) and the second element (200) are subjected to the first movement, and when the helical movement of the first element ( 100) relative to the second element (200) during one of the first movement and the second movement provides for a non-integer multiple rotation of the first element (100) relative to the second element (200), at least one of the conclusions (164, 166, 168) for contact is in a second pivot position after completion of the second movement, the second pivot position being different from the first pivot position.

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