Rotary sensor for injection device

Abstract

This application relates to a rotational sensor for an injection device, and more particularly to a rotational sensor for an injection device, the rotational sensor comprising: - a rotatable element configured for mechanical engagement with a ratchet mechanism, the rotatable element including an outer rim and a hub and configured to transmit torque between the outer rim and the hub; - at least one sensor attached to the rotatable element and configured to measure at least one of mechanical force, mechanical pressure, or mechanical strain at a portion of the rotatable element during rotation of the rotatable element; - a processor connected to the at least one sensor and configured to calculate a rotation angle of the rotatable element based on the sensor output of the at least one sensor.

Description

[0001] This invention application is a divisional application of the invention patent application filed on December 17, 2018, with application number 201880081331.9 (international application number PCT / EP2018 / 085112) and titled "Rotation Sensor for Injection Device". Technical Field

[0002] This disclosure relates to the field of rotation sensors, and particularly to rotation sensors configured for detecting and / or quantitatively measuring the rotation of components of an injection device. In one aspect, this disclosure relates to a rotation sensor implemented in an attachment configured for attaching to an injection device. In another aspect, this disclosure relates to a rotation sensor implemented in an injection device. In yet another aspect, this disclosure relates to an injection device equipped with a rotation sensor configured to detect and / or quantitatively measure the rotation of components of the injection device. In yet another aspect, this disclosure relates to a method for determining and / or quantitatively measuring the rotation of components of an injection device. Background Technology

[0003] Drug delivery devices for setting and dispensing single or multiple doses of liquid medication are well known in the art. Typically, such devices serve a purpose substantially similar to that of a conventional syringe.

[0004] Drug delivery devices (such as pen injectors) must meet many user-specific requirements. For example, patients with chronic conditions such as diabetes may be frail and visually impaired. Therefore, suitable drug delivery devices, especially those designed for home use, need to be robust in construction and easy to use. Furthermore, the manipulation and general handling of the device and its components should be clear and easy to understand. Such injection devices should provide the setting and subsequent dispensing of a variable-sized dose of medication. In addition, the dosage setting and dispensing procedure must be easy to operate and clearly defined.

[0005] Typically, such devices include a housing or a specific cartridge holder adapted to receive a cartridge at least partially filled with the medication to be dispensed. The device also includes a drive mechanism, typically having a displaceable piston rod operably engaged with a stopper or piston of the cartridge. By means of the drive mechanism and its piston rod, the stopper or piston of the cartridge can be displaced distally or in the dispensing direction, and thus a predefined amount of medication can be dispensed through a puncture assembly (e.g., in the form of an injection needle), releasably coupled to a distal section of the housing of the drug delivery device.

[0006] The medication to be dispensed by the drug delivery device can be provided and contained in multi-dose cartridges. Such cartridges typically comprise glass containers sealed distally by a puncture-resistant seal and proximally by a stopper. For reusable drug delivery devices, empty cartridges can be replaced with new ones. Conversely, disposable drug delivery devices are discarded entirely once the medication in the cartridge has been dispensed or used up.

[0007] For some drug delivery devices (such as pen-type injection devices), the user must set an equal or variable dose by rotating the dose selector dial clockwise or in a dose-increasing direction relative to the body or housing of the injection device. To inject and dispense a dose of liquid medication, the user must press a trigger or dose button distally and therefore toward the body or housing of the injection device. Typically, the user applies distally oriented pressure to the dose button (located proximal to the dose selector dial and dose selector sleeve) with their thumb while gripping the housing of the injection device with the remaining fingers of the same hand.

[0008] For mechanically operated injection devices, the desired outcome is accurate, reliable, and semi-automated monitoring and / or collection of injection-related data during use. Mechanically operated injection devices can be equipped with electronically implemented add-ons or data collection devices configured to monitor user-initiated actions. Data collection devices attached to the injection device should be relatively compact in terms of their geometry. For data collection devices configured for attachment to mechanically operated injection devices, the challenge is to detect and / or quantitatively measure manual actions performed by the user, such as when the user rotates the selector mechanism of the injection device during dose setting, or when rotatable parts of the injection device are rotated during dose dispensing.

[0009] However, for electronically implemented injection devices (e.g., injection devices equipped with electric actuators), it is desirable to provide accurate, reliable, and fail-safe quantitative measurements of the rotatable components of the injection device.

[0010] Purpose of the invention

[0011] Therefore, the objective is to provide an improved rotation sensor configured to detect and / or quantitatively measure the rotation of a rotatable component of an injection device. The rotation sensor and its principles should be generally applicable to injection devices and additional devices configured for attachment to such devices.

[0012] Rotation sensors should generally be applicable to a variety of different rotatable parts of injection devices or attachments. The manufacture of rotation sensors should be cost-effective and should feature a fairly compact design and geometry. Summary of the Invention

[0013] In one aspect, this disclosure relates to a rotational sensor for an injection device. The rotational sensor includes a rotatable element configured for mechanical engagement with a ratchet mechanism. The rotatable element includes an outer rim and a hub. It is configured to transmit torque between the outer rim and the hub. The rotational sensor also includes at least one sensor attached to the rotatable element and configured to measure at least one of a mechanical force, mechanical pressure, or mechanical strain at a portion of the rotatable element during rotation. The rotational sensor also includes a processor connected to the at least one sensor and configured to calculate a rotation angle of the rotatable element based on the sensor output of the at least one sensor.

[0014] Rotary sensors are commonly used in injection devices or are configured to be attached to and / or implemented with such injection devices. Rotary sensors can be implemented in attachments, such as monitoring devices configured to monitor the operation of the injection device. Alternatively, the rotary sensor can be implemented within the injection device itself. A ratchet mechanism can be located in the attachment or the injection device, for example, in the drive mechanism or dosage setting mechanism of the injection device.

[0015] A ratchet mechanism typically includes first and second parts in ratchet engagement. The first and second parts are rotatable relative to each other. One of the first and second parts includes a helical tooth, and the other includes at least one pawl or stop engaging the helical tooth, so that rotational movement of the first part relative to the second part can be applied, controlled, or prevented. Mechanical engagement, i.e., torsional or rotational coupling between the rotatable element and the ratchet mechanism, results in a change in torque between the outer rim and hub of the rotatable element, wherein the torque varies with the rotational angle of the rotatable element. Rotational-related changes in torque transmission across the rotatable element can be detected or quantitatively measured by means of at least one sensor.

[0016] During the rotation of the rotatable element, the ratchet mechanism also undergoes rotation. The pawl or stop of the second component of the ratchet mechanism regularly engages with the continuous teeth of the first component of the ratchet mechanism. Whenever a tooth of the first component passes the pawl or stop of the second component of the ratchet mechanism, the torque across the rotatable element increases or decreases significantly. Such increases or decreases in torque across the rotatable element can be detected by at least one sensor and can be further processed by a processor. Each detected positive or negative peak in torque across the rotatable element indicates that a component of the ratchet mechanism has rotated discontinuously, as determined by the periodicity of the toothed structure of the first component and / or the number and position of the pawl or stop of the second component of the ratchet mechanism.

[0017] The proposed rotation sensor is advantageous because it can be attached to an injection device or implemented within the device in various ways. The rotation sensor can be implemented with existing rotatable elements of the injection device or add-on. A rotation sensor may require modification of only one component of the existing injection device or add-on. The rotatable element may only need to be equipped with at least one sensor and processor.

[0018] In some embodiments, the rotatable element belongs to a ratchet mechanism. Here, the rotatable element may represent a first or second component of the ratchet mechanism. The rotatable element may include a toothed structure to engage at least with a pawl or stop of a second component of the ratchet mechanism. In another embodiment, the rotatable element may include at least a pawl or stop and may form a second component of the ratchet mechanism, which engages with a toothed ratchet of a first component of the ratchet mechanism.

[0019] According to another embodiment, at least one sensor is arranged on the outer rim. In this embodiment, the rotatable element is part of or forms part of a ratchet mechanism. When arranged on the outer rim, the sensor is configured to mechanically engage with another component of the ratchet mechanism. For example, the rotatable element may constitute a first component of the ratchet mechanism, the first component having a toothed structure on its outer circumference to engage at least with a pawl or stop of a second component of the ratchet mechanism. By positioning the sensor on the outer rim, it can directly engage mechanically with the pawl or stop of the second component of the ratchet mechanism.

[0020] At least one sensor may be located on the toothed structure of the first component of the ratchet mechanism. This will be detected by the at least one sensor whenever it engages with the pawl or stop of the second component. The at least one sensor may include a mechanical force sensor, a mechanical pressure sensor, or a mechanical contact sensor. Multiple sensors may be arranged along the circumference of the outer rim. It is conceivable that each tooth of the toothed structure of the rotatable element includes a separate sensor. For this purpose, the processor can be individually connected to any one of the sensors. The rotation sensor is then configured not only to determine the rotation angle but also to determine the angular position of the rotatable element, for example, relative to the housing of the injection device or an attachment.

[0021] According to another embodiment, the rotatable element includes at least two spokes. The outer rim and the hub are connected by at least two spokes. When there are only two spokes, the spokes are typically diametrically opposed to each other with respect to the centrally located hub of the rotatable element. For three spokes, the individual spokes may be separated by about 120° in the tangential or circumferential direction of the rotatable element. For four spokes, the angular spacing between the individual spokes may be about 90°, and so on. Typically, the spokes are equidistantly separated in the tangential or circumferential direction of the outer rim.

[0022] Compared to a configuration where the rotatable element is arranged as a solid disc with an outer rim and a hub, the overall weight of the rotatable element can be reduced by means of at least two or more spokes. With at least two spokes, torque transmission between the outer rim and the central hub can be easily detected and determined by means of at least one sensor.

[0023] Typically, at least two spokes, an outer rim, and a hub are integrally formed. The rotatable element may include a rotatable wheel. The outer rim may include a circular structure, and each spoke may each include a fairly straight, flat plate-like structure extending radially inward from the outer rim toward the hub. The rotatable element or rotatable wheel may include a rubber wheel, a plastic wheel, or a metal wheel. The specific material constituting the rotatable element may depend on the type of sensor attached to the rotatable element.

[0024] According to another embodiment, at least one sensor is attached to at least one of the at least two spokes. In another embodiment, it is conceivable that any one of the at least two spokes is provided with a separate sensor. Here, the sensors attached to the various spokes may be substantially identical, or they may belong to the same type of sensor. Furthermore, it is conceivable that several sensors are arranged on one of the at least two spokes, or that multiple sensors are provided on any one of the at least two spokes.

[0025] By arranging at least one sensor on at least one of the at least two spokes, torque transmission between the outer rim and the hub can be accurately detected using at least one of a mechanical force sensor, a mechanical pressure sensor, or a mechanical strain sensor. When torque is transmitted between the outer rim and the hub, the spokes may undergo elastic deformation. When attached to at least one of the at least two spokes, at least one sensor can detect or quantitatively determine this elastic deformation. When torque is applied to a rotatable element, spokes of relatively fine or slender dimensions may exhibit well-defined elastic deformation behavior. By arranging at least one sensor on at least one of the at least two spokes, such elastic deformation, indicating changes in torque transmitted between the outer rim and the hub, can be accurately detected and / or quantitatively determined.

[0026] According to another embodiment, at least one of the at least two spokes includes an outer portion connected to the outer rim, an inner portion connected to the hub, and an intermediate portion connecting the outer and inner portions. The cross-section of one of the inner, intermediate, and outer portions is smaller than the cross-section of the other. Therefore, at least one of the at least two spokes extends radially and includes a heterogeneous or variable cross-section. Variation in the cross-section of at least one spoke is advantageous because when torque is applied to the rotatable element, the corresponding spoke exhibits well-defined elastic deformation behavior. Typically, spokes exhibiting a heterogeneous or variable cross-section extending radially are equipped with or provided with at least one sensor.

[0027] According to another embodiment, the cross-section of the middle portion of at least one spoke is smaller than the cross-section of at least one of the outer and inner portions. In some embodiments, the cross-section of the middle portion is smaller than the cross-section of the outer portion and also smaller than the cross-section of the inner portion. Here, the outer and inner portions of the spoke may include substantially the same cross-section. In this way, the middle portion of the corresponding spoke includes or constitutes a structure with reduced structural strength of the corresponding spoke. The portion of the corresponding spoke with a reduced cross-section compared to other portions of the spoke may be provided with at least one sensor.

[0028] According to another embodiment, at least one sensor is arranged in one of the inner, middle, and outer portions, with a cross-section smaller than that of the other three portions. In this manner, at least one segment or portion of the spoke, having a reduced cross-section and exhibiting well-defined mechanical or elastic deformation behavior, is equipped with and connected to at least one sensor. In this respect, the mechanical or elastic deformation of a portion of the spoke can be accurately detected and / or quantitatively measured.

[0029] In another embodiment, at least one spoke includes or presents a reduced cross section in the inner portion (i.e., adjacent to the hub) and / or in the outer portion (i.e., adjacent to the rim).

[0030] It is conceivable that the cross-section of the middle section is larger than the cross-sections of both the inner and outer sections. For such a configuration, two sensors can be arranged on the respective spokes. One sensor can be attached to the inner part of the spoke, while the other sensor can be attached to the outer part of the corresponding spoke. When the rotatable element undergoes rotation (i.e., when the rotatable element transmits torque between the outer rim and the hub), both the inner and outer sections may experience well-defined elastic and detectable deformations, which can be simultaneously detected and / or quantitatively measured by the first sensor attached to the inner part and the second sensor attached to the outer part.

[0031] According to another embodiment, at least one of the at least two spokes is configured to elastically deform when transmitting torque between the hub and the rim. This is particularly advantageous when the elastically deformable spoke includes a portion with a reduced cross-section compared to the rest of the respective spoke. When torque is transmitted between the outer rim and the hub, the spoke may exhibit well-defined elastic deformation behavior in the region with the reduced cross-section.

[0032] According to another embodiment, at least one sensor comprises at least one of a quantum tunneling composite (QTC) integrated into or adhesively attached to a portion of a rotatable element, a force-sensing sensor, and a strain gauge. At least one sensor may be embedded in the rotatable element, for example, in at least one of at least two spokes of the rotatable element. In other embodiments, the sensor is adhesively attached to the outer surface of the rotatable element, for example, on the outer surface of at least one of at least two spokes.

[0033] When implemented as a QTC sensor, the corresponding sensor comprises a composite material of a metal and a non-conductive elastomeric adhesive. QTC sensors can be used as pressure sensors. The working principle of QTC utilizes so-called quantum tunneling. Without pressure applied to the QTC sensor, the conductive elements are too far apart to conduct electricity. When pressure is applied, the conductive elements move closer, and electrons can tunnel through the non-conductive elastomeric adhesive or insulator. This effect is far more pronounced than expected from classical effects (i.e., non-quantum effects). Classical resistance is linear, proportional to the distance between conductive elements, while quantum tunneling increases exponentially as the distance between conductive elements decreases, allowing resistance variations of up to 10⁻¹⁰ between the pressurized and unpressurized states. 12 times.

[0034] When implemented as a force-sensing resistor, the sensor may include a material whose resistance changes when a force or pressure is applied. Force-sensing resistors may include conductive polymers that change resistance in a predictable manner after a force is applied to their surface. They are typically supplied as polymer sheets or inks that can be applied via screen printing. The pressure-sensing film consists of conductive and non-conductive particles suspended in a matrix. The particles typically comprise an average size in the submicron range. Applying a force to the surface of the sensing film causes the particles to contact conductive electrodes, thereby changing the film's resistance.

[0035] For all resistance-based sensors, force-sensing resistors require a relatively simple interface and can operate satisfactorily in moderately harsh environments. Compared to other force sensors, force-sensing resistors have the advantage of limited size; typically, they are less than 0.5 mm thick. Force-sensing resistors can also be produced and manufactured at medium to low cost. They also exhibit good shock resistance. The electrical signal obtainable from a force-sensing resistor may be subject to considerable tolerances, and the measurement accuracy of such force-sensing resistors may be somewhat limited. For detecting changes in torque transmission across a rotatable element caused by a ratchet mechanism rotaryly coupled or rotaryly connected to the rotatable element, the accuracy and reliability of such force-sensing resistors will be sufficient.

[0036] When implemented as a strain gauge, the sensor of a rotating strain gauge is configured to measure strain on or across a rotating element. The most common type of strain gauge consists of an insulating, flexible backing supporting a pattern of metal foil. The strain gauge is attached to the rotating element using a suitable adhesive such as cyanoacrylate. When the rotating element or a portion thereof undergoes mechanical deformation, the foil of the strain gauge deforms, causing a change in its resistance. This change in resistance can be measured using a circuit such as a Wheatstone bridge. When an electrical conductor is stretched within its elastic range, its resistance typically increases. Conversely, when a conductor is compressed, its resistance may decrease. From the measured resistance of the strain gauge, the amount of stress or strain induced can be inferred.

[0037] When implemented as a sensor configured to measure or detect mechanical strain across a rotatable element, at least one or more strain gauges can be attached to a portion of a reduced cross-section of at least two spokes. Here, a first strain gauge can be adhesively attached to one side edge of the spoke. A second strain gauge can be attached to a second side edge of the same spoke. Thus, the first strain gauge can be attached to one side of the spoke, and the second strain gauge can be attached to a relatively positioned side of the same spoke. As the spoke will undergo mechanical deformation, one strain gauge will be stretched, while the other will be compressed. In this way, the mechanical deformation of the spoke can be measured redundantly. This increases the reliability, fault tolerance, and accuracy of the rotating sensor.

[0038] According to another embodiment, the rotatable element includes at least one ratchet feature configured to periodically engage with a reverse ratchet feature when the rotatable element is rotated relative to the at least one reverse ratchet feature. In this embodiment, the rotatable element constitutes or is part of a ratchet mechanism. The ratchet feature may include a toothed structure, and the reverse ratchet feature may include at least one pawl or stop to engage with the toothed structure of the ratchet feature. In this way, a varying braking effect applies to the rotatable element when it is subjected to the reverse ratchet feature. Implementing the rotatable element itself as a component of a ratchet mechanism makes it possible to measure, fairly directly, the change in torque across the rotatable element applied by the ratchet engagement of the at least one ratchet feature and the at least one reverse ratchet feature. In further...

[0039] In another embodiment, the rotatable element includes at least one reverse ratchet feature configured to periodically engage with the at least one ratchet feature when the rotatable element is rotated relative to the reverse ratchet feature. In this embodiment, the rotatable element constitutes or belongs to a ratchet mechanism and forms the reverse ratchet feature. The reverse ratchet feature may include at least one pawl or stop to engage with the toothed structure of the ratchet feature.

[0040] According to another embodiment, the processor is configured to detect the time variation of the amplitude of the sensor output. The sensor output is provided in the form of an electrical signal. By detecting the time variation and thus by continuously monitoring the sensor output, the variation of torque transmitted between the outer rim and the hub can be accurately detected. Whenever the sensor output exhibits a positive or negative peak, this indicates that the ratchet feature of the ratchet mechanism has exceeded the reverse ratchet feature of the ratchet mechanism. Since the number of ratchet features and reverse ratchet features of the ratchet mechanism is known to the processor, and since a fixed number of teeth on the ratchet features is assigned to the complete rotation of the rotatable element, the processor is configured to count the many consecutive peaks or variations of the transmitted torque. Since the number of counted torque variations is equal to the total number of teeth on the ratchet features, this clearly indicates that the rotatable element has undergone a complete rotation relative to the reverse ratchet feature.

[0041] In another aspect, this disclosure relates to an additional device for attachment to an injection device. The injection device includes at least a housing, a trigger, a selector, and a dispensing mechanism. The additional device includes a body configured for attachment to the selector and a rotary sensor as described above. Here, a rotatable element of the rotary sensor is rotatably locked to one of the selector or one of the housing and the trigger. The rotatable element can be rotated relative to the other of the selector or relative to one of the housing and the trigger via a ratchet mechanism. The ratchet mechanism may be part of the additional device. In another embodiment, the ratchet mechanism is implemented in the dispensing or dose setting mechanism of the injection device. However, changes in angular momentum can also be measured at the selector, which is rotatably coupled to or rotatably connected to the ratchet mechanism of the injection device.

[0042] In this regard, both the rotation sensor and the ratchet mechanism can be located within the attachment. In another embodiment, the rotation sensor is located inside and provided by the attachment, while the ratchet mechanism is disposed within or on the injection device.

[0043] In another aspect, this disclosure also relates to an injection device for setting and dispensing a dose of a pharmaceutical agent. The injection device includes a housing, a trigger for initiating and / or controlling dose dispensing, a selector rotatable relative to the housing for setting the dose, and a ratchet mechanism. The ratchet mechanism is typically rotatably connected to or rotatably coupled to the selector. The injection device also includes a rotation sensor as described above. Here, a rotatable element of the rotation sensor is rotatably locked to one of the selector and the housing. The rotatable element can be rotated relative to the other of the selector and the housing via the ratchet mechanism.

[0044] In another aspect, this disclosure relates to a method for detecting and / or quantitatively measuring the rotation of a rotatable element of an injection device or an attachment configured for attachment to such an injection device. The method includes the step of inducing torque on the rotatable element, wherein the rotatable element is mechanically engaged with a ratchet mechanism. In a subsequent step, at least one of a mechanical force, mechanical pressure, or mechanical strain is measured at a portion of the rotatable element by means of at least one sensor attached to the rotatable element. In a subsequent step, the output of the sensor is processed by a processor configured to calculate a rotation angle of the rotatable element based on the output of the at least one sensor.

[0045] Typically, the method can be implemented by a rotation sensor as described above, which can be implemented in an attachment for attaching to the injection device, or the rotation sensor can be implemented directly in the injection device.

[0046] In this document, the term 'distal' or 'far end' refers to the end of the injection device facing the injection site in a human or animal. The term 'proximal' or 'proximal end' refers to the opposite end of the injection device, which is furthest from the injection site in a human or animal.

[0047] As used in this article, the terms "drug" or "pharmaceutical preparation" refer to a pharmaceutical formulation containing at least one pharmaceutically active compound.

[0048] 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 antibody fragment, hormone or oligonucleotide, or a mixture of the above pharmaceutically active compounds.

[0049] In another embodiment, the pharmaceutically active compound may be used to treat and / or prevent diabetes or diabetes-related complications (such as diabetic retinopathy), thromboembolic diseases (such as deep vein or pulmonary thromboembolism), acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis.

[0050] In another embodiment, the pharmaceutically active compound includes at least one peptide for treating and / or preventing diabetes or diabetes-related complications such as diabetic retinopathy.

[0051] In another embodiment, the pharmaceutically active compound includes at least one human insulin or human insulin analog or derivative, glucagon-like peptide-1 (GLP-1) or its analog or derivative, or exendin-3 or exendin-4, or an analog or derivative of exendin-3 or exendin-4.

[0052] Insulin analogs include, 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 the 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.

[0053] Insulin derivatives include, 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; and B30-N-myristoyl-ThrB2 9LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin; B29-N-(N-lithochyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0054] Venomous exopeptide-4, for example, refers to venomous exopeptide-4 (1-39), a peptide having the following 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.

[0055] Venomous lizard exopeptide-4 derivatives, for example, are selected from the following list of compounds:

[0056] H-(Lys)4-desPro36,desPro37 Venomous Lizard Exopeptide-4(1-39)-NH2、

[0057] H-(Lys)5-desPro36,desPro37 Venomous Lizard Exopeptide-4(1-39)-NH2、

[0058] des Pro36 Venomous Lizard Exopeptide-4(1-39)

[0059] des Pro36[Asp28] Venomous Lizard Exopeptide-4(1-39),

[0060] des Pro36[IsoAsp28] Venomous Lizard Exopeptide-4(1-39),

[0061] des Pro36[Met(O)14,Asp28]exotropic peptide-4(1-39),

[0062] des Pro36[Met(O)14,IsoAsp28]exotropic peptide-4(1-39),

[0063] des Pro36[Trp(O2)25,Asp28]exotropic peptide-4(1-39),

[0064] des Pro36[Trp(O2)25,IsoAsp28]exotropic peptide-4(1-39),

[0065] des Pro36[Met(O)14Trp(O2)25,Asp28]exotropic peptide-4(1-39),

[0066] des Pro36[Met(O)14Trp(O2)25,IsoAsp28] lizard exopeptide-4(1-39); or

[0067] des Pro36[Asp28] Venomous Lizard Exopeptide-4(1-39),

[0068] des Pro36[IsoAsp28] Venomous Lizard Exopeptide-4(1-39),

[0069] des Pro36[Met(O)14,Asp28]exotropic peptide-4(1-39),

[0070] des Pro36[Met(O)14,IsoAsp28]exotropic peptide-4(1-39),

[0071] des Pro36[Trp(O2)25,Asp28]exotropic peptide-4(1-39),

[0072] des Pro36[Trp(O2)25,IsoAsp28]exotropic peptide-4(1-39),

[0073] des Pro36[Met(O)14Trp(O2)25,Asp28]exotropic peptide-4(1-39),

[0074] des Pro36[Met(O)14Trp(O2)25,IsoAsp28] venomous lizard exopeptide-4 (1-39), wherein the group -Lys6-NH2 can bind to the C-terminus of the venomous lizard exopeptide-4 derivative;

[0075] Or a lizard exopeptide-4 derivative having the following sequence:

[0076] des Pro36 Venomous Lizard Exopeptide-4(1-39)-Lys6-NH2(AVE0010),

[0077] H-(Lys)6-des Pro36[Asp28]exotropic peptide-4(1-39)-Lys6-NH2,

[0078] des Asp28 Pro36,Pro37,Pro38 Venomous Lizard Exopeptide-4(1-39)-NH2、

[0079] H-(Lys)6-des Pro36,Pro38[Asp28]exotropic peptide-4(1-39)-NH2、

[0080] H-Asn-(Glu)5des Pro36,Pro37,Pro38[Asp28]exotropic peptide-4(1-39)-NH2、desPro36,Pro37,Pro38[Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2、

[0081] H-(Lys)6-des Pro36,Pro37,Pro38[Asp28] Venomous Lizard Exopeptide-4(1-39)-(Lys)6-NH2、

[0082] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2、

[0083] H-(Lys)6-des Pro36[Trp(O2)25,Asp28] venomous lizard exopeptide-4(1-39)-Lys6-NH2, H-desAsp28 Pro36,Pro37,Pro38[Trp(O2)25] venomous lizard exopeptide-4(1-39)-NH2, H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28] venomous lizard exopeptide-4(1-39)-NH2,

[0084] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]exotropic peptide-4(1-39)-NH2、

[0085] des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2、

[0086] H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2、

[0087] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2、

[0088] H-(Lys)6-desPro36[Met(O)14,Asp28]exotropic peptide-4(1-39)-Lys6-NH2、

[0089] des Met(O)14Asp28 Pro36,Pro37,Pro38 Venomous Lizard Exopeptide-4(1-39)-NH2、

[0090] H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14,Asp28]exotropic peptide-4(1-39)-NH2、

[0091] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Asp28]exotropic peptide-4(1-39)-NH2、

[0092] des Pro36,Pro37,Pro38[Met(O)14,Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2、

[0093] H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2、

[0094] H-Asn-(Glu)5des Pro36,Pro37,Pro38[Met(O)14,Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2、

[0095] H-Lys6-des Pro36[Met(O)14,Trp(O2)25,Asp28]exotropic peptide-4(1-39)-Lys6-NH2,

[0096] H-des Asp28 Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25]exotropic peptide-4(1-39)-NH2、

[0097] H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Asp28]exotropic peptide-4(1-39)-NH2、

[0098] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]exotropic peptide-4(1-39)-NH2、

[0099] des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2、

[0100] H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]exotropic peptide-4(S1-39)-(Lys)6-NH2,

[0101] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]exotropic peptide-4(1-39)-(Lys)6-NH2;

[0102] Or a pharmaceutically acceptable salt or solvate of any of the above-mentioned lizard exopeptide-4 derivatives.

[0103] Hormones are, for example, pituitary or hypothalamic hormones or regulatory peptides and their antagonists listed in Chapter 50 of the Rote Liste, 2008 edition, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, gamete maturation hormone), somatropine (growth hormone), desmopressin, terlipressin, gonarelin, triptorelin, leuprorelin, buserrelin, nafarelin, and goserelin.

[0104] Polysaccharides are, for example, glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof, or sulfated forms of the above polysaccharides (e.g., polysulfated forms), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium.

[0105] Antibodies are globular plasma proteins (approximately 150 kDa), also known as immunoglobulins sharing a basic structure. They are glycoproteins because they have sugar chains added to amino acid residues. The basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only one Ig unit); secreted antibodies can also be dimers with two Ig units (such as IgA), tetramers with four Ig units (such as bony fish IgM), or pentamers with five Ig units (such as mammalian IgM).

[0106] Ig monomers are Y-shaped molecules composed of four polypeptide chains; two identical heavy chains and two identical light chains are 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. Both heavy and light chains contain intrachain disulfide bonds that stabilize their folding. Each chain consists of domains called Ig domains. These domains contain approximately 70–110 amino acids and are categorized according to their size and function (e.g., variable regions or V regions and constant regions or C regions). These domains exhibit a characteristic immunoglobulin fold, where the two β-folds form a "sandwich" shape, held together by interactions between conserved cysteine ​​residues and other charged amino acids.

[0107] There are five types of mammalian Ig heavy chains, denoted by α, δ, ε, γ, and μ. The type of heavy chain present defines the isotype of the antibody; these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively.

[0108] The different heavy chains vary in size and composition; α and γ contain approximately 450 amino acids, δ contains approximately 500 amino acids, and μ and ε contain approximately 550 amino acids. Each heavy chain has a constant region (C0). H ) and variable region (V H The heavy chains consist of two regions. Within a species, the constant region is substantially the same across all antibodies of the same isotype, but differs across 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 increased flexibility; heavy chains μ and ε have a constant region consisting of four immunoglobulin domains. The variable region of the heavy chains differs across antibodies produced by different B cells, but is identical for all antibodies produced by a single B cell or a B cell clone. Each variable region of the heavy chain is approximately 110 amino acids long and consists of a single Ig domain.

[0109] In mammals, there are two types of immunoglobulin light chains, denoted by λ and κ. A light chain has two continuous domains: a constant domain (CL) and a variable domain (VL). The approximate length of a light chain is 211 to 217 amino acids. Each antibody contains two identical light chains; in mammals, each antibody possesses only one type of light chain, either κ or λ.

[0110] Although all antibodies share a very similar general structure, the unique properties of a given antibody are determined by variable (V) regions, as detailed above. More specifically, variable loops (three on each light chain (VL) and three on each heavy chain (VH)) are responsible for binding the antigen, i.e., for its antigen specificity. These loops are called complementarity-determining regions (CDRs). Because multiple CDRs from the VH and VL domains constitute the antigen-binding site, it is the combination of the heavy and light chains (rather than each individually) that determines the final antigen-specific combination.

[0111] An "antibody fragment" comprises at least one antigen-binding fragment as defined above and exhibits essentially the same function and specificity as the intact antibody derived from it. Restrictive proteolysis with papain cleaves the Ig prototype into three fragments. Two identical N-terminal fragments are antigen-binding fragments (Fab), each containing a complete L-chain and approximately half an H-chain. The third fragment is a crystallizable fragment (Fc), similar in size but containing half of the carboxyl terminus of both heavy chains and their interchain disulfide bonds. Fc contains a carbohydrate, a complement binding site, and an FcR binding site. Restricted pepsin digestion yields a single F(ab')2 fragment containing both a Fab segment and a hinge region, including the HH interchain disulfide bond. F(ab')2 is divalent for antigen binding. The disulfide bonds of F(ab')2 can be cleaved to obtain Fab'. Furthermore, the variable regions of the heavy and light chains can be fused together to form a single-chain variable fragment (scFv).

[0112] 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 having cations selected from: alkali or alkaline earth metals, such as Na+, or K+, or Ca2+, or ammonium ions N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently represent: hydrogen, optionally substituted C1-C6-alkyl groups, optionally substituted C2-C6-alkenyl groups, optionally substituted C6-C10-aryl groups, or optionally substituted C6-C10-heteroaryl groups. Other examples of pharmaceutically acceptable salts are described in: Remington's Pharmaceutical Sciences, 17th edition, Alfonso R. Gennaro (ed.), Mark Publishing Company, Easton, Pa., USA, 1985, and Encyclopedia of Pharmaceutical Technology.

[0113] Pharmaceutically acceptable solvates are, for example, hydrates.

[0114] Specifically, the present invention relates to the following:

[0115] 1. A rotation sensor for an injection device (1), the rotation sensor comprising:

[0116] - A rotatable element (201) configured for mechanical engagement with a ratchet mechanism (90; 190), the rotatable element (201) including an outer rim (208) and a hub (210) and configured for transmitting torque between the outer rim (208) and the hub (210).

[0117] - At least one sensor (220, 222, 224) is attached to the rotatable element (201) and configured to measure at least one of mechanical force, mechanical pressure, or mechanical strain at a portion of the rotatable element (201) during rotation of the rotatable element (201).

[0118] - A processor (112) connected to the at least one sensor (220, 222, 224) and configured to calculate the rotation angle of the rotatable element based on the sensor output of the at least one sensor (220, 222, 224).

[0119] 2. The rotation sensor according to claim 1, wherein the at least one sensor (224) is arranged on the outer rim (208).

[0120] 3. The rotation sensor according to any one of the preceding claims, wherein the rotatable element (201) includes at least two spokes (204, 206), and wherein the outer rim (208) and the hub (210) are connected by the at least two spokes (204, 206).

[0121] 4. The rotation sensor according to claim 3, wherein the at least one sensor (220, 222, 224) is attached to at least one of the at least two spokes (204, 206).

[0122] 5. The rotation sensor according to item 3 or 4, wherein at least one of the at least two spokes (204, 206) includes an outer portion (207) connected to the outer rim (208), an inner portion (209) connected to the hub (210), and an intermediate portion (211) connecting the outer portion (207) and the inner portion (209), and wherein the cross-section of one of the inner portion (209), the intermediate portion (211), and the outer portion (207) is smaller than the cross-section of the other of the inner portion (209), the intermediate portion (211), and the outer portion (207).

[0123] 6. The rotation sensor according to claim 5, wherein the cross-section of the intermediate portion (211) is smaller than the cross-section of at least one of the outer portion (207) and the inner portion (209).

[0124] 7. The rotation sensor according to item 5 or 6, wherein the at least one sensor (220, 222, 224) is arranged such that the cross section of one of the inner portion (209), the intermediate portion (211), and the outer portion (207) is smaller than the cross section of the other of the inner portion (209), the intermediate portion (211), and the outer portion (207).

[0125] 8. The rotation sensor according to any one of items 3 to 7 above, wherein at least one of the at least two spokes (204, 206) is configured to elastically deform when transmitting torque between the hub (210) and the rim (208).

[0126] 9. The rotation sensor according to any one of the preceding claims, wherein the at least one sensor (220, 222, 224) comprises at least one of a quantum tunneling composite material (QTC), a force-sensing resistor, and a strain gauge integrated into or adhered to a portion of the rotatable element (201).

[0127] 10. The rotation sensor according to any one of the preceding claims, wherein the rotatable element (201) includes at least one ratchet feature (212) configured to periodically engage with the reverse ratchet feature (240; 340) when the rotatable element (201) is rotated relative to at least one reverse ratchet feature (240; 340).

[0128] 11. The rotation sensor according to any one of the preceding claims, wherein at least one of the ratchet feature (212) and the reverse ratchet feature (240; 340) includes a flexible or pivotable arm (242; 342) configured to flex or pivot relative to the other of the ratchet feature (212) and the reverse ratchet feature (240; 340) such that rotation of the ratchet feature (212) can exceed that of the at least one reverse ratchet feature (240; 340).

[0129] 12. The rotation sensor according to any one of the preceding items, wherein the processor (112) is configured to detect the time change of the amplitude of the sensor output.

[0130] 13. An attachment for attaching to an injection device, wherein the injection device includes at least a housing (10), a trigger (11), a selector (12), and a dispensing mechanism (8), wherein the attachment includes:

[0131] - A main body (101) configured to be attached to the selector member (12),

[0132] - The rotary sensor (200) according to any one of the preceding items, wherein the rotatable element (201) is rotatably locked to one of the selector members (12) or one of the housing (10) and the trigger (11), and wherein the rotatable element (201) is rotatable relative to the other of the selector members (12) or one of the housing (10) and the trigger (11) by a ratchet mechanism (190).

[0133] 14. An injection device for setting and dispensing a specific dose of a drug, the injection device comprising:

[0134] -Shell (10),

[0135] -A trigger (11) to initiate and / or control the expulsion of the dose,

[0136] - A selector (12) that can rotate relative to the housing (10) for setting the dosage.

[0137] - Ratchet mechanism (90), and

[0138] - A rotary sensor (200) according to any one of items 1 to 12 above, wherein the rotatable element (201) is rotatably locked to one of the selector (12) and the housing (10), and wherein the rotatable element (201) is rotatable relative to the other of the selector (12) and the housing (10) via the ratchet mechanism (90).

[0139] 15. A method for detecting and / or quantitatively measuring the rotation of a rotatable element of an injection device or a rotatable element of an additional device configured for attachment to such an injection device, the method comprising the steps of:

[0140] - A torque is generated on the rotatable element (201), wherein the rotatable element (201) is mechanically engaged with the ratchet mechanism (90; 190).

[0141] -Measuring at least one of mechanical force, mechanical pressure, or mechanical strain at a portion of the rotatable element (201) by at least one sensor (220, 222, 224) attached to the rotatable element (201), and

[0142] - The processor processes the output of the sensors (220, 222, 224) and is configured to calculate the rotation angle of the rotatable element (201) based on the output of the at least one sensor (220, 222, 224).

[0143] It will be apparent to those skilled in the art that various changes and modifications can be made to this disclosure without departing from its spirit and scope. Furthermore, it should be noted that any reference numerals used in the appended claims should not be construed as limiting the scope of this disclosure. Attached Figure Description

[0144] In the following, numerous embodiments of the container and injection device will be described in more detail with reference to the accompanying drawings, wherein:

[0145] Figure 1 An embodiment of the injection device is shown.

[0146] Figure 2 Shown in exploded perspective view Figure 1 The injection device

[0147] Figure 3 A block diagram of the additional device is shown.

[0148] Figure 4 This is a longitudinal cross-sectional view of the attachment when it is attached to the proximal end of the injection device.

[0149] Figure 5 This is a perspective schematic diagram of a rotary sensor including rotatable elements and a reverse ratchet feature.

[0150] Figure 6 This is a separate partial illustration of another embodiment of the rotatable element.

[0151] Figure 7 This is a partial view of a rotary sensor including rotatable elements and a ratchet mechanism.

[0152] Figure 8 This is a schematic diagram of the sensor signal when a rotatable element undergoes rotation.

[0153] Figure 9 This is a schematic diagram of the elastic deformation of a rotatable element when it undergoes rotation along a first rotation direction.

[0154] Figure 10 This is a schematic diagram of a rotatable element when there is no torque.

[0155] Figure 11 This is a schematic diagram of the elastic deformation of a rotatable element when it undergoes rotation along a second rotation direction.

[0156] Figure 12 A flowchart of a method for determining or detecting rotation, and

[0157] Figure 13 This is a schematic diagram of the measurement circuit of the sensor connected to the rotation sensor. Detailed Implementation

[0158] like Figure 1 and Figure 2 The injection device 1 shown is a pre-filled, disposable injection device, comprising a housing 10 to which an injection needle 15 can be fixed. The injection needle 15 is protected by an inner needle cap 16 and an outer needle cap 17 or a protective cap 18, the protective cap being configured to surround and protect the distal section of the housing 10 of the injection device 1. The housing 10 may include and form a main housing portion configured to accommodate, for example... Figure 2The drive mechanism 8 is shown. The injection device 1 may further include a distal housing component, indicated as a cartridge holder 14. The cartridge holder 14 may be permanently or releasably connected to the main housing 10. The cartridge holder 14 is typically configured to receive a cartridge 6 filled with a liquid medication. The cartridge 6 includes a cylindrical or tubular body 25 that is sealed in the proximal direction 3 by a stopper 7 located within the body 25. The stopper 7 can be displaced in the distal direction 2 relative to the body 25 of the cartridge 6 by a piston rod 20. The distal end of the cartridge 6 is sealed by a punctureable seal 26 configured as a diaphragm and punctureable by a proximal-oriented tip of an injection needle 15. The cartridge holder 14 includes a threaded port 28 at its distal end for threaded engagement with a corresponding threaded portion of the injection needle 15. By attaching the injection needle 15 to the distal end of the cartridge holder 14, the seal 26 of the cartridge 6 is penetrated, thereby establishing a fluid delivery pathway into the interior of the cartridge 6.

[0159] When the injection device 1 is configured to administer, for example, human insulin, the dose set by the dose selector 12 at the proximal end of the injection device 1 can be displayed in so-called International Units (IU, where 1 IU is the bioequivalent of approximately 45.5 μg of pure crystalline insulin (1 / 22 mg)). The dose selector 12 may include or may be formed as a dose selector.

[0160] like Figure 1 and Figure 2 As further shown, housing 10 includes a dose window 13, which may be in the form of an aperture in housing 10. The dose window 13 allows a user to view a limited portion of a digital sleeve 80, which is configured to move when the dose selector dial 12 is rotated to provide a visual indication of the currently set dose. When rotated during dose setting and / or dispensing or discharging, the dose selector dial 12 rotates in a helical path relative to housing 10.

[0161] The injection device 1 can be configured such that turning the dosage knob 12 produces a mechanical click to provide acoustic feedback to the user. The digital sleeve 80 interacts mechanically with the piston in the insulin cartridge 6. When the needle 15 is inserted into the patient's skin and the trigger 11 or injection button is actuated, the insulin dose displayed in the display window 13 is dispensed from the injection device 1. A higher percentage of the dose is actually injected into the patient while the needle 15 of the injection device 1 remains in the skin for a certain period after the trigger 11 is actuated. The dispensing of the insulin dose can also cause a mechanical click, but it is different from the sound produced when using the dosage selector dial 12.

[0162] In this embodiment, during insulin dose delivery, the dose selector 12 rotates to its initial position in axial movement, that is, it does not rotate, while the digital sleeve 80 rotates back to its initial position, for example, displaying a dose of zero units.

[0163] The injection device 1 can be used for several injection processes until the cartridge 6 is emptied or the drug in the injection device 1 reaches its expiration date (e.g., 28 days after the first use).

[0164] Additionally, before the first use of the injection device 1, a so-called "prime shot" may be necessary to remove air from the cartridge 6 and needle 15, for example, by selecting 2 units of medication and pressing the trigger 11 while keeping the needle 15 of the injection device 1 facing upwards. For ease of presentation, it will be assumed below that the injection volume substantially corresponds to the injection dose, such that, for example, the dose of medication injected from the injection device 1 is equal to the dose received by the user.

[0165] Figure 2 An embodiment of the drive mechanism 8 is illustrated in more detail. It comprises a number of mechanically interacting components. The flange-like support of the housing 10 includes a threaded axially through opening that threadedly engages with the first thread or distal thread 22 of the piston rod 20. The distal end of the piston rod 20 includes a bearing 21 on which a pressure foot 23 is freely rotatable about the longitudinal axis of the piston rod 20. The pressure foot 23 is configured to axially abut against the proximal thrust receiving surface of the stopper 7 of the cartridge 6. During the dispensing action, the piston rod 20 rotates relative to the housing 10, thereby undergoing a distally oriented propulsive movement relative to the housing 10 and therefore relative to the barrel 25 of the cartridge 6. As a result, due to the threaded engagement of the piston rod 20 with the housing 10, the stopper 7 of the cartridge 6 is displaced by a defined distance in the distal direction 2.

[0166] The piston rod 20 also has a second thread 24 at its proximal end. The distal thread 22 and the proximal thread 24 have opposite directions of rotation.

[0167] A drive sleeve 30 is also provided, having a hollow interior to receive the piston rod 20. The drive sleeve 30 includes an internal thread that engages with the proximal thread 24 of the piston rod 20. Furthermore, the drive sleeve 30 includes an externally threaded section 31 at its distal end. The threaded section 31 is axially constrained between a distal flange portion 32 and another flange portion 33 located at a predetermined axial distance from the distal flange portion 32. Between the two flange portions 32, 33, a final dose limiter 35 in the form of a semi-circular nut is provided, having an internal thread that mates with the threaded section 31 of the drive sleeve 30.

[0168] The final dose limiter 35 further includes radial recesses or protrusions on its outer periphery to engage with complementary-shaped recesses or protrusions on the inner sidewall of the housing 10. In this way, the final dose limiter 35 is splined to the housing 10. During continuous dose setting, rotation of the drive sleeve 30 in the dose increment direction 4 or clockwise results in cumulative axial displacement of the final dose limiter 35 relative to the drive sleeve 30. An annular spring 40 is also provided, axially abutting the proximal surface of the flange portion 33. Furthermore, a tubular connector 60 is provided. At a first end, the connector 60 has a series of circumferentially oriented serrations. A radially inwardly oriented flange is positioned toward the second opposite end of the connector 60.

[0169] Furthermore, a dose selection sleeve, also referred to as a digital sleeve 80, is provided. The digital sleeve 80 is located outside the spring 40 and the connector 60, and radially inside the housing 10. A helical groove 81 is provided around the outer surface of the digital sleeve 80. The housing 10 is provided with a dose window 13 through which a portion of the outer surface of the digital sleeve 80 can be seen. The housing 10 also has helical ribs on the inner wall portion of the insert 62, which will seat in the helical groove 81 of the digital sleeve 80. The tubular insert 62 is inserted into the proximal end of the housing 10. It is rotatably and axially fixed to the housing 10. A first stop and a second stop are provided on the housing 10 to limit the dose setting procedure during which the digital sleeve 80 rotates helically relative to the housing 10. As will be explained in more detail below, at least one stop is provided by a preselector stop feature 71 provided on the preselector 70.

[0170] A dose selector disc 12, in the form of a dose selector handle, is disposed around the outer surface of the proximal end of the digital sleeve 80. The outer diameter of the dose selector disc 12 typically corresponds to and matches the outer diameter of the housing 10. The dose selector disc 12 is fixed to the digital sleeve 80 to prevent relative movement between them. The dose selector disc 12 has a central opening.

[0171] Trigger 11, also referred to as a dose button, is essentially T-shaped. It is located at the proximal end of the injection device 10. The handle 64 of trigger 11 extends through an opening in the dose selector disc 12, through the inner diameter of the extension of the drive sleeve 30, and into a receiving recess at the proximal end of the piston rod 20. The handle 64 is held to allow restricted axial movement within the drive sleeve 30 and to prevent rotation relative to the drive sleeve. The head of trigger 11 is generally rounded. A trigger sidewall or skirt extends from the periphery of the head and is further adapted to be positioned in a proximal accessible annular recess of the dose selector disc 12.

[0172] To select a dose, the user rotates the dose selection disc 12. With the spring 40 also acting as a pawl and the engagement device 60 engaged, the drive sleeve 30, spring or pawl 40, engagement device 60, and digital sleeve 80 rotate with the dose selection disc 12. Auditory and tactile feedback for dose selection is provided by the spring 40 and engagement device 60. Torque is transmitted via serrations between the spring 40 and engagement device 60. The helical groove 81 on the digital sleeve 80 and the helical groove on the drive sleeve 30 have the same lead. This allows the digital sleeve 80 to extend from the housing 10 and the drive sleeve 30, climbing the piston rod 20 at the same speed. At the limit of travel, a radial stop on the digital sleeve 80 engages with a first or second stop provided on the housing 10 to prevent further movement in the first rotational direction (e.g., in the dose increment direction 4). Rotation of the piston rod 20 is prevented due to the opposite directions of the integral thread and the driven thread on the piston rod 20.

[0173] As the drive sleeve 30 rotates, the final dose limiter 35, bonded to the housing 10, advances along the threaded section 31. Upon reaching the final dose dispensing position, a radial stop formed on the surface of the final dose limiter 35 abuts against a radial stop on the flange portion 33 of the drive sleeve 30, preventing further rotation of the final dose limiter 35 and the drive sleeve 30.

[0174] If the user accidentally selects an excessive dose, the injection device 1, configured as a pen injector, allows for the dispensing of a smaller dose without dispensing medication from the cartridge 6. For this purpose, the dose selection disc 12 simply rotates in the reverse direction. This causes the system to run in reverse. A flexible arm of the spring or pawl 40 acts as a ratchet, preventing the spring 40 from rotating. The torque transmitted through the coupling 60 causes the serrations to overlap, producing a clicking sound corresponding to the reduction in the selected dose. Typically, the serrations are arranged such that the circumferential extension of each serration corresponds to a unit dose. Here, the coupling can function as a ratchet mechanism.

[0175] As an alternative or supplement, the ratchet mechanism 90 may include at least one ratchet feature 91, such as a flexible arm on the sidewall of the tubular connector 60. The at least one ratchet feature 91 may include, for example, a radially outwardly extending protrusion on the free end of the flexible arm. The protrusion is configured to engage with a correspondingly formed reverse ratchet structure inside the digital sleeve 80. The interior of the digital sleeve 80 may include longitudinally formed grooves or protrusions with a serrated profile.

[0176] During dose selection or setting, the ratchet mechanism 90 allows and supports the rotation of the digital sleeve 80 relative to the connector 60 along a second rotational direction 5, accompanied by a regular clicking sound from the flexible arm of the connector 60. The angular momentum applied to the digital sleeve 80 along the first rotational direction is invariably transmitted to the connector 60. Here, the corresponding ratchet features of the ratchet mechanism 90 provide torque transmission from the digital sleeve 80 to the connector 60.

[0177] Once the desired dose has been selected, the user can simply dispense the set dose by pressing trigger 11. This causes the connector 60 to axially displace relative to the digital sleeve 80, disengaging its teeth. However, the connector 60 remains engaged with the drive sleeve 30 during rotation. The digital sleeve 80 and the dose selection disc 12 are now free to rotate according to the helical groove 81.

[0178] Axial movement deforms the flexible arm of spring 40 to ensure that the serrations are not overturned during dispensing. This prevents drive sleeve 30 from rotating relative to housing 10, although it remains free to move axially relative to housing. This deformation is then used to push spring 40 and coupling 60 back along drive sleeve 30 to restore the connection between coupling 60 and digital sleeve 80 when the distally oriented dispensing pressure is removed from trigger 11.

[0179] The longitudinal axial movement of the drive sleeve 30 causes the piston rod 20 to rotate through a through opening in the support of the housing 10, thereby advancing the stopper 7 within the cartridge 6. Once the selected dose has been dispensed, further rotation of the digital sleeve 80 is prevented by contact between at least one stop extending from the dose selection disc 12 and at least one corresponding stop in the housing 10. The zero-dose position can be determined by the abutment of the axially extending edge of the digital sleeve 80 or one of the stops with at least one or more corresponding stops in the housing 10.

[0180] The discharge mechanism or drive mechanism 8 described above is merely an example of one of many different configurations of drive mechanisms that are typically implemented in disposable pen syringes. The drive mechanism described above is explained in more detail in, for example, WO2004 / 078239A1, WO 2004 / 078240 A1 or WO 2004 / 078241 A1, the entire contents of which are incorporated herein by reference.

[0181] like Figure 2 The illustrated dose setting mechanism 9 includes at least a dose selector 12 and a digital sleeve 80. During dose setting and when the dose selector 12 is rotated for dose setting, the digital sleeve 80 begins to rotate relative to the housing along a helical path, which is defined by the threaded engagement of the external thread or helical groove 81 of the digital sleeve with a corresponding threaded section formed on the inner surface of the housing.

[0182] During dose setting and when the drive mechanism 8 or dose setting mechanism 9 is in dose setting mode, the drive sleeve 30 rotates in conjunction with the dose selector dial 12 and the digital sleeve 80. The drive sleeve 30 is threadedly engaged with the piston rod 20, which is stationary relative to the housing 10 during dose setting. Therefore, the drive sleeve 30 undergoes a helical or spiral motion during dose setting. When the dose selector dial rotates in the first rotational direction or in the dose increment direction 4 (e.g., clockwise), the drive sleeve 30 begins to travel in the proximal direction. To adjust or correct the dose, the dose selector dial 12 can rotate in the opposite second rotational direction, and thus in the dose decrement direction 5 (e.g., counterclockwise).

[0183] Figures 5 to 11 The diagram illustrates the working principle of the rotation sensor 200. The rotation sensor 200 includes a rotatable element 201. The rotatable element 201 may include a wheel 202. The rotation sensor 200 also includes at least one sensor 220, 222, or 224, such as... Figure 5 As shown. Multiple sensors of the same or different types can be connected to or embedded in the rotatable element 201. Sensors 220, 222, and 224 include at least one of a QTC, a force-sensing resistor, and a strain gauge. By applying several sensors 220, 222, and 224 to different parts of the rotatable element 201, fail-safe and redundant measurements of the torque transmitted between the outer rim 208 and the hub 210 of the rotatable element 201 can be simultaneously detected by several sensors 220, 222, and 224. In principle, typically only one sensor 220, 222, or 224 is sufficient to detect changes in torque transmission between the outer rim 208 and the hub 210.

[0184] The rotatable element 201 is mechanically engaged with ratchet mechanisms 90 and 190. The ratchet mechanism 90 can be implemented in the injection device 1. It can be combined... Figure 3 and Figure 4 The ratchet mechanism 190 is implemented in the described additional device 100.

[0185] exist Figure 5 and Figure 6 In the illustration, the rotatable element 201 of the rotary sensor 200 coincides with a component of the ratchet mechanism 190. For this purpose, the rotatable element 201 includes at least one ratchet feature 212. Multiple ratchet features 212 may be provided on the outer rim 208 of the rotatable element 201. The ratchet features 212 may be arranged equidistantly on the outer circumference of the rotatable element 201. They may be located on the radially outward side edges of the wheel 202. The various ratchet features 212 may have the same or equal geometry. Each ratchet feature 212 may include or may constitute ratchet teeth.

[0186] Therefore, each ratchet feature 212 includes a beveled edge 214 facing the first rotation direction 4. The ratchet feature 212 also includes a side surface 216 facing the second rotation direction 5. The first and second rotation directions are opposite to each other. Figure 5 As illustrated, the beveled edge 214 faces clockwise, while the flange 216 faces counterclockwise. The ratchet feature 212 can exhibit a symmetrical geometry. Therefore, as seen in the circumferential or tangential direction of the wheel 202, the beveled edge 214 and the side surface 216 can be symmetrical to each other. In other embodiments, the shape and / or slope of the beveled edge 214 can differ from the shape and / or slope of the side surface 216.

[0187] The ratchet mechanism 190 can support rotation of the rotatable element 201 along a first rotation direction 4 and along a second rotation direction 5. The ratchet mechanism 190 can be implemented such that the rotatable element 209 can be rotated relative to the reverse ratchet feature 240 only along one of the first rotation direction 4 and the second rotation direction 5, wherein rotation along the other of the first rotation direction 4 and the second rotation direction 5 is prevented or prohibited.

[0188] Furthermore, when supporting and allowing rotation along the first rotation direction 4 and rotation along the second rotation direction 5, the ratchet mechanism 190 can be configured to provide a variable mechanical resistance or a braking effect of varying magnitude. The magnitude of the braking effect caused by the reverse ratchet feature 240 on the rotatable element 201 can depend on the rotation direction. The torque required to rotate the rotatable element 201 along the first rotation direction 4 can be different from the torque required to rotate the rotatable element 201 relative to the reverse ratchet feature 240 along the second rotation direction 5. In this figure, the rotatable element 201 can rotate relative to the reverse ratchet feature 240. The reverse ratchet feature 240 can be fixed or connected to the housing 10 of the injection device 1. The reverse ratchet feature 240 can also be connected to the housing 101 of the auxiliary device 100. Similarly, it is conceivable that the rotatable element 201 is rotatably locked to the respective housings 10, 101, while the reverse ratchet feature 240 is subjected to rotation, for example, during dose setting or dose dispensing performed by the injection device 1.

[0189] The reverse ratchet feature 240 includes a flexible arm 241, which includes at least one protrusion 242 configured to mechanically engage with at least one ratchet feature 212 of the rotatable element 201. The protrusion 242 includes a beveled edge 244 and a side surface 246. The beveled edge 244 may face a second rotational direction 5, while the side surface 246 is located at an opposite edge of the protrusion 242. The side surface 246 may face a first rotational direction 4.

[0190] The beveled edges 240, 244 of the rotatable element 201 and the reverse ratchet feature 240 are complementary in shape. The same applies to the corresponding sides 216, 246. In this way, the rotatable element 201 can rotate relative to the reverse ratchet feature 240, while at least one ratchet feature 212 periodically engages with a correspondingly shaped protrusion 242 of the reverse ratchet feature 240. In a typical implementation, the reverse ratchet feature 240 includes only one or a limited number of radially inwardly extending protrusions 242, and the rotatable element 201 includes a toothed structure having a plurality of continuous and equidistantly arranged teeth or ratchet features 212 on the radially outward edge of the outer rim 208.

[0191] The mechanical engagement of one or more ratchet features 212 with the reverse ratchet feature 240 causes a varying torque across the rotatable element 201. The hub 210 of the rotatable element 201 is rotatably fixed to a component of the injection device 1 or the auxiliary device 100. As the rotatable element 201 undergoes rotation, for example during a dose setting operation or a dose dispensing operation, torque is transmitted between the outer rim 208 and the centrally positioned hub 210. Because the ratchet mechanism 190 causes a variation in torque across the rotatable element, various sensors 220, 222, 224 are configured to measure such variations in torque transmission.

[0192] The processor 112, connected to sensors 220, 222, and 224, is configured to measure the temporal variation of the transmitted torque. Any temporal variation of the transmitted torque detected by at least one sensor 220, 222, or 224 directly indicates that the ratchet feature 212 of the rotatable element 201 has overtaken the correspondingly formed reverse ratchet feature 240. Since the number and arrangement of the ratchet features 212 and the reverse ratchet features 240 are known, the processor 112 is able to determine the rotation angle by counting the number of detectable variations in the torque transmitted between the outer rim 208 and the hub 210.

[0193] like Figure 5 , Figure 6 and Figures 9 to 11 The illustrated rotatable element 201 includes a plurality of spokes 204, 206. The spokes 204, 206 form a mechanical connection between the outer rim 208 and the hub 210. Torque can be transmitted between the outer rim 208 and the hub 210 via the spokes 204, 206. A plurality of spokes can be provided, such as two spokes, three spokes, four or even more spokes 204, 206. With a relatively limited number of spokes, the various spokes may be easily affected by mechanical deformation when transmitting torque between the outer rim 208 and the hub 210.

[0194] Typically, spokes 204, 206 are arranged equidistantly along the inner circumference of the outer rim 208 or along the outer circumference of the hub 210. Spokes 204, 206 are configured to elastically deform when torque is transmitted between the outer rim 208 and the hub 210. By arranging at least one sensor 220, 222, 224 on at least one of the spokes 204, 206, the degree of elastic deformation of the respective spoke 204, 206 can be detected and / or quantitatively determined. To have a well-defined deformation behavior at least in a portion of the spokes, each spoke 204, 206 may include a portion with a reduced cross-section.

[0195] like Figure 9 As illustrated in more detail, the spokes 204 include an outer portion 207 connected to the outer rim 208. The spokes 204 also include an inner portion 209 connected to the hub 210. The spokes 204 further include an intermediate portion 211 located between the outer portion 207 and the inner portion 209. The intermediate portion 211 has a smaller or reduced cross-section compared to the cross-sections of the outer portion 207 and the inner portion 209. In this manner and as... Figure 9 and Figure 11 As shown, the middle portion 211 is particularly susceptible to mechanical deformation. As shown, when a torque is applied to the hub 210 along the first rotation direction 4, the middle portion 211 undergoes geometric deformation.

[0196] As shown in the figure, and because the outer rim 208 engages with the fixed reverse ratchet feature 240, the outer rim 208 experiences corresponding mechanical resistance to resist rotation along the first rotation direction 4. Here, the reverse ratchet feature 240 can be arranged at or within the housing 101 of the auxiliary device 100. Alternatively, the reverse ratchet feature 240 can be disposed or positioned on or within the housing 10 of the injection device 1.

[0197] Accordingly, and depending on the magnitude of the change in braking effect caused by the corresponding ratchet feature 212 and the reverse ratchet feature 240, the middle portion 211 of the spokes 204 undergoes regular mechanical deformation when the rotatable element 201 rotates along the first rotation direction 4. At least one sensor 220 is connected to or attached to the middle portion 211. Figure 9 , Figure 10 and Figure 11 In the illustrated embodiment, sensor 220 includes two strain gauges 226 and 228. The first strain gauge 226 is attached to the side of the spoke 204 facing the second rotation direction 5. The second strain gauge 228 is disposed on the side of the spoke 204 facing the first rotation direction 4. In other words, the two strain gauges 226 and 228 are located on opposite sides of the spoke 204.

[0198] like Figures 9 to 11As further shown, strain gauges 226 and 228 are located on opposite sides of the middle portion 211 of the spokes 204. When a torque is applied to the hub 210 along the first direction 4, the outer portion 207 undergoes displacement relative to the inner portion 209 along the second rotational direction 5. Accordingly, strain gauge 226 is compressed, while strain gauge 228 is stretched. In another case, where the hub 210 is subjected to torque along the second rotational direction 5, the rim 208 undergoes circumferential or tangential displacement relative to the hub 210 along the first rotational direction 4. Accordingly and as Figure 11 As shown, strain gauge 226 is under tension and strain gauge 228 is under compression.

[0199] In such Figure 10 In the neutral configuration illustrated, where no substantial torque is applied to the rotatable element 201, there is no substantial compression or tension effect for either of the strain gauges 226 or 228.

[0200] When the rotatable element 201 rotates, for example, during dosage setting and / or during dosage dispensing, along a first rotation direction 4 or a second rotation direction 5, the intermediate portion 211 undergoes repetitive mechanical deformation detectable and measurable by the sensor 220. Typically, the degree of mechanical deformation is proportional to the magnitude of the torque transmitted between the rim 208 and the hub 210.

[0201] In other configurations, it is conceivable that an external torque is applied to the outer rim 208 and thus transmitted radially inward from the outer rim 208 to the centrally positioned hub 210. The middle portion 211 will then undergo corresponding deformation.

[0202] The magnitude or degree of deformation directly corresponds to the magnitude of the torque transmitted between the outer rim 208 and the hub 210. Because the rotatable element 201 is mechanically or rotatably engaged with the ratchet mechanism 190, the torque transmitted between the outer rim 208 and the hub 210 undergoes... Figure 8 The change is shown. Whenever the ratchet feature 212 of the rotatable element 201 passes the reverse ratchet feature 240, the transmitted torque exhibits the following characteristics: Figure 8 The detectable drop 262 is shown in graph 260. At least one sensor 220, 222, 224 of the rotation sensor 200 can detect each detectable peak or drop 262 in graph 260.

[0203] Taking strain gauges 226 and 228 as examples, Figure 13 The diagram illustrates one of a plurality of measurement circuits 280, configured to measure the changing resistance of at least one of strain gauges 226, 228. The strain gauges 226, 228 are arranged in a Wheatstone bridge circuit, as shown... Figure 13As illustrated, the measurement circuit 280 includes a first reference resistor 281 and a second reference resistor 282, both having known and constant resistances. Resistors 281 and 282 are arranged in parallel. Resistor 282 is connected in series with strain gauge 226. Resistor 281 is connected in series with strain gauge 228. Strain gauges 226 and 228 are also connected in parallel. Two opposite vertices of the measurement circuit 280 are connected to a current source 284. A node 283 is provided between reference resistor 282 and strain gauge 226. Another node 285 is provided between reference resistor 281 and strain gauge 228. A voltage across the two nodes 283 and 285 can be detected that directly indicates the variable resistance of strain gauge 226 and / or strain gauge 228. In this way, the variable resistance of strain gauges 226 and 228 can be detected and quantitatively measured, thereby supporting the detection of peaks or drops 262 in graph 260 when the rotatable element 201 is rotated relative to the reverse ratchet feature 240.

[0204] exist Figure 12 The diagram illustrates a method for measuring the rotation of a rotatable element 201. In a first step 300, torque is induced or applied to the rotatable element when it is mechanically engaged with ratchet mechanisms 90, 190 of the injection device 1 or the auxiliary device 100, respectively. Subsequently, in a further step 302, the sensor outputs of at least one sensor 220, 222, 224 are measured. In a further step 304, the measured sensor outputs are processed by a processor 112. The processor 112 and its electrical connection to at least one sensor 220, 222, 224 are configured to monitor the time variation of the amplitude of the sensor outputs. The time variation or specific peak value in the output or output signal of at least one sensor 220, 222, 224 indicates that the rotatable element has rotated discontinuously, wherein the step size is controlled and determined by the geometry and interaction of the ratchet mechanisms 90, 190.

[0205] When the rotation sensor 200 is implemented as follows Figure 1 and Figure 2In the illustrated injection device, it can be positioned on a rotatable element 201, such as a rotatable connector 60, which includes a connector sleeve having a flexible ratchet feature 91 that engages with a digital sleeve 80 via a ratchet. For dosage setting, the digital sleeve 80 is rotated relative to the connector 60. Here, the ratchet feature, including a flexible arm with radially outwardly extending protrusions, regularly engages with a correspondingly formed reverse ratchet feature located on an inner wall section of the digital sleeve 80. During dosage setting, the selector 12 engages with the digital sleeve 80 in a torsional engagement. The ratchet engagement between the digital sleeve 80 and the connector 60 is periodically and comprehensively checked as the selector 12 rotates in at least one of a first rotation direction 4 and a second rotation direction 5. The torque required to rotate the dose selector or dose member 12 in a first rotation direction 4 or a second rotation direction 5, for example, to reduce the dose or to correct the dose setting, is subject to regular variation due to the ratchet engagement between the digital sleeve 80 and the coupling 60.

[0206] In principle, any rotatable component arranged in the torque transmission between the connector 60 and the dose selector 12 can be used as the rotatable element 201 as described above. For example, the dose selector 12 itself can be configured as the rotatable element 201.

[0207] exist Figure 3 and Figure 4 The diagram schematically illustrates the implementation of the rotary sensor 200 in the auxiliary device 100. Here, the auxiliary device 100 includes a housing 101 configured for assembly to the proximal end of the pen-type injection device 1. The auxiliary device 100 also includes an insert 140 rotatably connected to and thus rotatably locked to the housing 101. The insert 140 includes a skirt 141 configured for frictional or active locking engagement with a rotatable dose selector disc 12. A pressure member 150 is also provided rotatably supported within the housing 101. The pressure member 150 is freely rotatable relative to the housing 101. The pressure member 150 includes a disc segment 151 and a longitudinal rod 152 extending longitudinally from the radial center of the disc segment 151. The free end of the rod 152 opposite to the disc segment 151 is rotatably locked or rotatably locked to a trigger 11.

[0208] At least during either dose setting or dose dispensing, the trigger 11 is rotatably locked to the housing 10 of the injection device 1. The trigger 11 can be pressed down in the distal direction 2 by means of a rod 152 axially abutting the trigger 11, via a pressure member 150. The pressure member 150 is axially abutting or axially engaged with the housing 101 of the auxiliary device 100. The housing 101 is axially slidably displaced relative to the insert 140. When the insert 140 is axially fixed to the selector member 12, the housing 101 can be axially displaced in the distal direction 2 relative to the insert 140 to initiate the dose dispensing procedure. In this way, by pushing the housing 101 of the auxiliary device 100 in the distal direction 2 relative to the housing 100 of the injection device 1, the trigger 11 can be displaced in the distal direction 2 relative to the housing 10.

[0209] The rod 152 is in a form-fit engagement or a friction engagement with the trigger 11. Rotation relative to the housing 10 of the injection device 1 is impeded. The rod 152 intersects with the rotatable element 201 of the rotation sensor 200. The rod 152 is rotatably locked to the rod 210 of the rotatable element 201. It can engage with the rod 210 via a spline. For this purpose, at least one of the holes in the rod 152 and the hub 210 includes a radial protrusion that engages with a corresponding radially shaped recess in the other of the rod 152 and the hub 210.

[0210] like Figure 4 The illustrated housing 101 also includes a compartment for receiving electronic components of the auxiliary device 100. A receiving space 160 is provided between the pressure member 150 and the proximal end face of the housing 101. This receiving space 160 is configured to receive a printed circuit board 102 on which a processor 112 is disposed. The processor 112 is electrically connected to sensors 220, 222, and 224. The receiving space 160 is also configured to receive a power source 120, such as a button battery.

[0211] like Figure 4 As illustrated, the rotatable element 201 is radially located inside the reverse ratchet feature 240 of the insert 140. When the housing 101 of the auxiliary device 100 rotates relative to the housing 10 of the injection device, thereby inducing torque on the dose selector 12, the insert 140 and therefore the reverse ratchet feature 240 rotate relative to the rotatable element 201 according to the ratchet mechanism 190, which is composed of the ratchet feature 212 of the rotatable element 201 and the reverse ratchet feature 240 of the insert 140.

[0212] In this regard, such as Figure 4 The implementation of the rotation sensor 200 in the auxiliary device 100 is as follows: Figure 5 , Figure 6 and Figures 9 to 11 The illustrations of the rotation sensor 200 shown in either of the above are directly compatible.

[0213] exist Figure 7 Another embodiment of the rotation sensor 200 is illustrated in the figure. Here, the rotatable element 201 includes only... Figure 7 The rotatable wheel 202 is shown in the section. Wheel 202 includes a plurality of ratchet features 212 arranged regularly or irregularly. Each ratchet feature represents a tooth of the ratchet mechanism 90. A reverse ratchet feature 340 is also provided, including a flexible arm 341 with a radially inwardly extending protrusion 342. The protrusion 342 includes a beveled edge 344 and a side surface 346 on relatively positioned circumferential or tangential side edges. When the rotatable element 201 rotates relative to the reverse ratchet feature 340, the reverse ratchet feature 340 undergoes repeated and regular elastic bending. Figure 7 As shown, a sensor 224 is provided at the radially outwardly positioned tip of the ratchet feature 212. Here, the sensor 224 can be implemented as a pressure sensor or a contact sensor, configured to detect mechanical contact between any ratchet feature 212 and the reverse ratchet feature 340. The processor 112 processes the electrical signals generated by at least one sensor or multiple sensors 224 to indicate that the rotatable element 201 has rotated discontinuously relative to the reverse ratchet feature 340. The step size is controlled and determined by the geometry and position of the ratchet feature 212.

[0214] The rotatable element 201 forms a first component of the ratchet mechanism 90, and the reverse ratchet feature 240 forms a second component of the ratchet mechanism 90. The ratchet feature 212 of the rotatable element 201 forms or constitutes the teeth of the ratchet mechanism of the first ratchet component. The reverse ratchet feature 242 of the reverse ratchet feature 240 includes, forms, or constitutes a pawl or stop configured to engage with the ratchet feature 212.

[0215] Figure 3 This is a block diagram of the auxiliary device 100. The auxiliary device 100 may include a data collection device. The auxiliary device 100 includes a processor 112 together with a memory 114, the processor including one or more processors such as a microprocessor, digital signal processor (DSP), application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), etc. The memory 114 may include program memory and main memory, which may store software executed by the processor 112 and data generated during the use of the auxiliary device 100, such as counted pulses, derived dose magnitudes, timestamps, etc. A switch 122 connects a power supply 120 to the electronic components of the device 100, including a sensor assembly 110. A display 118 may or may not be present. The sensor assembly 110 includes at least a rotation sensor 200 configured to detect and / or quantitatively measure rotational movement between the housing 10 of the injection device 1 and the dose selector disk 12.

[0216] The resolution of sensor assembly 110 is determined by the design of injection device 1. The appropriate angular resolution of sensor assembly 110 can be determined by equation (1):

[0217]

[0218] For example, if a complete rotation of the selector 12 corresponds to a dose of 24 IU, then the appropriate resolution of the sensor assembly 110 will not exceed 15°.

[0219] Typically, the rotation angle of the dose selector disc 12 or selector member, measured by the rotation sensor 200, is proportional to the dose of medication dispensed. It is not necessary to determine the zero level or absolute amount of medication contained in the injection device 1. When the dose selector disc 12 is rotated relative to the housing 10 during the dispensing of a given dose of medication, the actual dose dispensed can be accurately determined and monitored by the auxiliary device 100. Here, the rotation sensor 200 provides direct and therefore more reliable information about the injected dose of medication compared to data collection devices that determine the set and therefore intended-to-dispense dose of medication.

[0220] The auxiliary device 100 includes an interface 124 connected to the processor 112. The interface 124 may be for communication via a wireless network (e.g., Wi-Fi or...). The interface 124 is a wireless communication interface for communicating with another external device 65 (e.g., in the form of a portable electronic device), or an interface for a wired communication link, such as a socket for receiving a Universal Serial Bus (USB), Micro USB, or Micro USB connector. For this purpose, interface 124 includes a transceiver 126 configured to send and receive data. Figure 3 An embodiment of an injection system is depicted, in which an additional device 100 is connected via a data connection 66 to an external electronic device 65 (such as a personal computer 65) for data transfer. The data connection 66 can be of wired or wireless type.

[0221] For example, processor 112 may store the exact dosage and timestamp of the administered medication given by the user at the time of injection, and subsequently transfer the stored data to external electronic device 65. Device 65 maintains a treatment log and / or sends treatment history information to a remote location, for example, for review by medical personnel.

[0222] The add-on device 100 or data collection device can be configured to store data such as delivery doses and timestamps for up to multiple injection events (e.g., 35 or more injection events). For a once-daily injection therapy, this would be sufficient to store approximately one month's treatment history. Data storage is organized in a first-in, first-out (FIFO) manner, ensuring that the most recent injection event is always present in the memory of the data collection device 100. Once transferred to an external electronic device 65, the injection event history in the add-on device 100 is deleted. Alternatively, data may remain in the add-on device 100 and the oldest data may be automatically deleted immediately after new data is stored. In this way, a log is built up over time during use and will always include the most recent injection events. Alternatively, other configurations may include storage capacity for 70 injection events (twice daily), 100 injection events (3 months), or any other suitable number, depending on the user's therapy needs and / or preferences.

[0223] In another embodiment, interface 124 may be configured to send information using a wireless communication link and / or processor 112 may be configured to periodically send such information to external electronic device 65.

[0224] The processor 112 can control an optional display 118 to show determined drug dosage information and / or show the time elapsed since the last dose was delivered. For example, the processor component 112 can cause the display 118 to periodically switch between displaying the most recently determined drug dosage information and the elapsed time.

[0225] Power source 120 can be a battery. Power source 120 can be a coin cell battery or multiple coin cells arranged in series or parallel. Timer 115 can also be set. In addition to or instead of turning the auxiliary device 100 on and off, switch 122 can be arranged to trigger timer 115 upon engagement and / or disengagement. For example, if timer 115 is triggered on both engagement and disengagement of the first and second electrical contacts of the switch, or on both operation and deactivation of switch 122, processor 112 can use the output from timer 115 to determine the length of time during which trigger 11 is depressed, for example, to determine the duration of injection.

[0226] Alternatively or additionally, processor 112 may use timer 115 to monitor the length of time elapsed since the injection was completed, as indicated by the disengagement time of the corresponding switching element or the cessation of operation of switch 122. Optionally, the elapsed time may be displayed on display 118. Also optionally, upon the next operation of switch 122, processor 112 may compare the elapsed time with a predetermined threshold to determine whether the user may be attempting to administer another injection too quickly after the previous injection, and if so, generate an alarm (such as an audible signal) and / or warning message on display 118 or via output 116. Output 160 may be configured to generate an audible sound or induce vibration, thereby producing a tactile signal, for example, to alert the user.

[0227] On the other hand, if the elapsed time is extremely short, it may indicate that the user is receiving a dose of medication as a "split dose," and the processor 112 may store information indicating that the dose is delivered in this manner. In such a scenario, the elapsed time is compared to a predetermined threshold ranging from a few seconds (e.g., 10 seconds) to several minutes (e.g., 5 minutes). For example, the predetermined threshold is set to 2 minutes. If the elapsed time since the last injection is 2 minutes or less, the processor 112 stores information indicating that the dose is delivered as a "split dose."

[0228] Another optional purpose of monitoring elapsed time via processor 112 is to determine when elapsed time exceeds a predetermined threshold, indicating that the user may have forgotten to give another injection, and if so, to generate an alarm.

[0229] List of reference numerals

[0230] 1. Injection device

[0231] 2. Distal direction

[0232] 3. Proximal direction

[0233] 4. Direction of dose escalation

[0234] 5. Direction of dose reduction

[0235] 6 medicine cartridges

[0236] 7. Stopper

[0237] 8. Drive mechanism

[0238] 9. Dosage setting mechanism

[0239] 10. Shell

[0240] 11 Triggers

[0241] 12 Dosage Selection Panel

[0242] 13 Dosage window

[0243] 14. Cartridge Holder

[0244] 15 injection needles

[0245] 16 Inner needle cap

[0246] 17 Outer pin cap

[0247] 18 Protective Helmet

[0248] 19. Protrusion

[0249] 20 Piston Rod

[0250] 21 bearings

[0251] 22 First Thread

[0252] 23 Pressure feet

[0253] 24 Second Thread

[0254] 25 cylinder

[0255] 26. Seals

[0256] 28 Threaded socket

[0257] 30 drive sleeve

[0258] 31 Threaded Section

[0259] 32 flange

[0260] 33 Flange

[0261] 35. Last dose limiter

[0262] 36 Shoulder platform

[0263] 40 springs

[0264] 41. Depression

[0265] 50 dose trackers

[0266] 51 Tracking stop feature

[0267] 60 connector

[0268] 62 Inserts

[0269] 64 strokes

[0270] 80 digital sleeve

[0271] 81 Groove

[0272] 90 Ratchet Mechanism

[0273] 91 Ratchet Feature

[0274] 100 Additional Devices

[0275] 101 Casing

[0276] 102 Printed Circuit Board

[0277] 110 Sensor Assembly

[0278] 112 processor

[0279] 114 Memory

[0280] 115 Timer

[0281] 116 Output

[0282] 118 monitor

[0283] 120 power supply

[0284] 122 Switch

[0285] 124 interface

[0286] 126 transceiver

[0287] 140 Inserts

[0288] 141 Skirt

[0289] 150 Pressure Components

[0290] 151 Disc Section

[0291] 152 strokes

[0292] 160 cubic meters of space

[0293] 190 Ratchet Mechanism

[0294] 200 Rotary Sensor

[0295] 201 Rotatable Component

[0296] 202 rounds

[0297] 204 spokes

[0298] 206 spokes

[0299] 207 External Parts

[0300] 208 rims

[0301] 209 Internal Section

[0302] 210 wheels

[0303] 211 Middle section

[0304] 212 Ratchet Feature

[0305] 214 Beveled edge

[0306] 216 Side View

[0307] 220 sensor

[0308] 222 Sensors

[0309] 224 sensors

[0310] 226 Strain Gauge

[0311] 228 Strain Gauge

[0312] 240 Reverse ratchet feature

[0313] 241 Flexible Arm

[0314] 242 protrusions

[0315] 244 Beveled edge

[0316] 246 Side View

[0317] 260 charts

[0318] 262 decreased

[0319] 280 Measurement Circuit

[0320] 281 Reference Resistor

[0321] 282 Reference Resistor

[0322] 283 nodes

[0323] 284 Current Source

[0324] 285 nodes

[0325] 340 Reverse ratchet feature

[0326] 341 Flexible Arm

[0327] 342 protrusion

[0328] 344 Beveled edge

[0329] 346 Side View

Claims

1. A rotation sensor for an injection device (1), the rotation sensor comprising: - a rotatable element (201) configured for mechanical engagement with a ratchet mechanism (90; 190), the rotatable element (201) comprising an outer rim (208) and a hub (210) and being configured for transmitting torque between the outer rim (208) and the hub (210), wherein the rotatable element (201) further comprises at least one ratchet feature (212) configured to periodically engage with at least one counter-ratchet feature (240; 340) when the rotatable element (201) is subjected to rotation relative to the counter-ratchet feature (240; 340), or wherein the rotatable element (201) further comprises at least one counter-ratchet feature (240; 340) configured to periodically engage with at least one ratchet feature (212) when the rotatable element (201) is subjected to rotation relative to the ratchet feature (212), - at least one sensor (220, 222, 224) attached and arranged to a portion of the rotatable element (201) and configured to: (1) measure a stepwise rotation of the rotatable element (201) relative to the counter-ratchet feature (240; 340) when the at least one ratchet feature (212) is in mechanical engagement with the at least one counter-ratchet feature (240; 340), or (2) measure a stepwise rotation of the rotatable element (201) relative to the ratchet feature (212) when the at least one counter-ratchet feature (240; 340) is in mechanical engagement with the at least one ratchet feature (212), - a processor (112) connected to the at least one sensor (220, 222, 224) and configured to calculate a rotation angle of the rotatable element based on a sensor output of the at least one sensor (220, 222, 224).

2. The rotation sensor according to claim 1, wherein at least one of the ratchet feature (212) and the counter-ratchet feature (240; 340) comprises a flexible or pivotable arm (242; 342) configured to flex or pivot relative to the other of the ratchet feature (212) and the counter-ratchet feature (240; 340) to enable rotation of the ratchet feature (212) to exceed the at least one counter-ratchet feature (240; 340).

3. The rotation sensor according to claim 1 or 2, wherein the ratchet feature (212) comprises a toothed structure, and wherein the counter-ratchet feature (240; 340) comprises at least one pawl or stop to engage with the toothed structure of the ratchet feature. ​ 4. The rotation sensor according to claim 1, wherein the counter-ratchet feature comprises at least one pawl or detent to engage with the toothed structure of the ratchet feature.

5. The rotation sensor according to claim 1 or 2, wherein the processor (112) is configured to detect a temporal change in the amplitude of the sensor output.

6. The rotation sensor according to claim 5, wherein the temporal change in the amplitude of the sensor output or a specific peak indicates that the rotatable element (201) has rotated a discrete step, wherein the step size is controlled and determined by the geometry and interaction of the ratchet mechanism 90, 190.

7. The rotation sensor according to claim 1 or 2, wherein the at least one sensor (220, 222, 224) is configured to measure at least one of a mechanical force or a mechanical strain at a portion of the rotatable element (201) during rotation of the rotatable element (201).

8. The rotation sensor according to claim 1 or 2, wherein the at least one sensor (220, 222, 224) is configured to measure a mechanical pressure at a portion of the rotatable element (201) during rotation of the rotatable element (201).

9. The rotation sensor according to claim 1 or 2, wherein the ratchet mechanism (90; 190) is configured to enable rotation of the rotatable element (209) in only one of a first rotational direction (4) and a second rotational direction (5), and wherein the ratchet mechanism (90; 190) is further configured to prevent rotation of the rotatable element (209) in the other of the first rotational direction (4) and the second rotational direction (5).

10. An add-on device for attachment to an injection device, wherein the injection device comprises at least a housing (10), a trigger (11), a dialing member (12), and an expelling mechanism (8), wherein the add-on device comprises: - a main body (101) configured for attachment to the dialing member (12), - a rotation sensor (200) according to any one of claims 1-9, wherein the rotatable element (201) is rotatably locked to one of the dialing member (12) or one of the housing (10) and the trigger (11), and wherein the rotatable element (201) is rotatable relative to the other of the dialing member (12) or one of the housing (10) and the trigger (11) by a ratchet mechanism (190).

11. An injection device for setting and expelling a dose of a medicament, the injection device comprising: - a housing (10), - a trigger (11) to initiate and / or control the expelling of the dose, - a dialing member (12) rotatable relative to the housing (10) for setting the dose, - a ratchet mechanism (90), and - a rotation sensor (200) according to any one of claims 1-9. - The rotary sensor (200) according to any of the preceding claims 1 to 9, wherein the rotatable element (201) is rotationally locked to one of the dialing member (12) and the housing (10), and wherein the rotatable element (201) is rotatable relative to the other one of the dialing member (12) and the housing (10) by the ratchet mechanism (90).

12. A method for detecting and / or quantitatively measuring a rotation of a rotatable element of an injection device or of a rotatable element of an add-on device configured for attachment to such an injection device, the method comprising the steps of: - inducing a torque to a rotatable element (201), wherein the rotatable element (201) is in mechanical engagement with a ratchet mechanism (90; 190), and wherein the rotatable element (201) comprises at least one ratchet feature (212) configured to periodically engage with at least one counter ratchet feature (240; 340) when the rotatable element (201) is subjected to a rotation relative to the at least one counter ratchet feature (240; 340), - measuring a stepwise rotation of the rotatable element (201) by at least one sensor (220, 222, 224) attached and disposed onto a portion of the rotatable element (201) when the at least one ratchet feature (212) is in mechanical engagement with the at least one counter ratchet feature (240; 340), and - processing an output of the sensor (220, 222, 224) by a processor configured to calculate a rotation angle of the rotatable element (201) based on the output of the at least one sensor (220, 222, 224).

Images