Medication delivery device for delivering a medication to a user

Abstract

A medication delivery device (110) for delivering a medication to a user and a method for determining a dysfunctional operation of a medication delivery device (110) are disclosed. The medication delivery device (110) comprising: — at least one actuator (118) configured for rotating at least one actuator shaft (120); — at least one transmission mechanism (124), wherein the transmission mechanism (124) comprises at least one transmission output shaft (126) that is configured to be coupled to a dispensing element, wherein the transmission mechanism (124) is configured for transmitting rotational movements of the actuator shaft (120) to the transmission output shaft (126) for advancing the dispensing element for dispensing liquid out of a reservoir (114) of the medication delivery device (110); — at least one first angle sensor (128) configured for determining at least one first rotational movement of the actuator shaft (120); — at least one second angle sensor (130) configured for determining at least one second rotational movement of the transmission output shaft (126); and — at least one controller (132) configured for determining a dysfunctional deviation between the first rotational movement of the actuator shaft (120) and the second rotational movement of the transmission output shaft (126).

Description

[0001] P39273 -EP

[0002] - 1 -

[0003] Roche Diabetes Care GmbH March 26, 2025

[0004] RD39273EP ST / KV

[0005] Medication delivery device for delivering a medication to a user

[0006] Technical Field

[0007] The present invention relates to a medication delivery device for delivering a medication, specifically a liquid medication, to a user and a method for determining a dysfunctional operation of the medication delivery device, for example an occlusion of a medication delivery device. The invention further relates to a computer program and a computer-readable storage medium for performing the method. The medication delivery device and the method may, as an example, be used in the field of home care for delivering a medication, specifically a liquid medication, to a user, such as for delivering insulin to a user. Other applications are generally feasible.

[0008] Background art

[0009] Delivering medication to a user, specifically insulin delivery, is important in the prevention and treatment of diseases, in particular in the treatment of diabetes mellitus. Besides by using injection pens or syringes, insulin delivery may specifically be performed by using insulin pumps.

[0010] Electronically driven medication delivery devices are generally prone to malfunction or failure due to failure of electronic or electromechanical components and / or due to failure in the medication delivery components, e.g. due to occlusion. In the field of delivering medicine, such as insulin, exact administration and control of the amount of medication may be of particular importance. Thus, monitoring and / or controlling of a proper functioning of the medication delivery device may be crucial.P39273 -EP

[0011] - 2 -

[0012] EP 3 124066 Al discloses a liquid-drug administration device including an actuator, gears driven by the actuator, an output shaft provided on the rotation axis of the gear to slide a plunger in a syringe for containing liquid-drug, and an occlusion detector provided between the actuator and the output shaft to detect occlusion in a flow passage for liquid-drug supplied from a syringe. The occlusion detector includes a fixed slit disk that has a slit in its disk face and rotates in synchronization with the rotation of the actuator, a slit disk that has a slit in its disk face and rotates in synchronization with the rotation of the output shaft, the slit disk being coaxially and overlappingly assembled to the fixed slit disk, and an elastic member that connects the fixed slit disk to the slit disk to cause a delay in rotation of the slit disk with respect to the rotation of the fixed slit disk in response to the rise in the back pressure on the slit disk.

[0013] Despite the advantages achieved by known methods and devices, several technical challenges remain. Specifically, precise and reliable detection of malfunction, such as occlusion detection, of medication delivery devices may still be technically challenging. Usually, various sensors, such as force sensors, pressure sensors or the like, may be used for detecting an occlusion of a fluid path in medication delivery devices. Alternatively, some devices and methods may determine an occlusion depending on a rotation of a driving shaft. For example, known medication delivery devices may use a stepper motor for driving the delivery of the medication to the user. The steps performed by the stepper motor may be determined by a sensor and may be used to estimate the state of the medication delivery device. In general, the sensor may be inherently inaccurate causing an inaccurate and not reliable detection of the malfunction of the medication delivery device. Thus, there is still a need for improving detection of malfunction at medication delivery devices.

[0014] Problem to be solved

[0015] It is therefore desirable to provide methods and devices which at least partially address above-mentioned technical challenges. Specifically, a medication delivery device for delivering a medication to a user and a method for determining a dysfunctional operation of a medication delivery device shall be provided which allow for a precise, reliable and fast detection of a dysfunctional operation state of the medical delivery device.

[0016] SummaryP39273 -EP

[0017] - 3 -

[0018] This problem is addressed by a medication delivery device for delivering a medication to a user and a method for determining a dysfunction operation of a medication delivery device with the features of the independent claims. Advantageous embodiments which might be realized in an isolated fashion or in any arbitrary combinations are listed in the dependent claims as well as throughout the specification.

[0019] As used in the following, the terms “have”, “comprise” or “include” or any arbitrary grammatical variations thereof are used in a non-exclusive way. Thus, these terms may both refer to a situation in which, besides the feature introduced by these terms, no further features are present in the entity described in this context and to a situation in which one or more further features are present. As an example, the expressions “A has B”, “A comprises B” and “A includes B” may both refer to a situation in which, besides B, no other element is present in A (i.e. a situation in which A solely and exclusively consists of B) and to a situation in which, besides B, one or more further elements are present in entity A, such as element C, elements C and D or even further elements.

[0020] Further, it shall be noted that the terms “at least one”, “one or more” or similar expressions indicating that a feature or element may be present once or more than once typically will be used only once when introducing the respective feature or element. In the following, in most cases, when referring to the respective feature or element, the expressions “at least one” or “one or more” will not be repeated, non-withstanding the fact that the respective feature or element may be present once or more than once.

[0021] Further, as used in the following, the terms "preferably", "more preferably", "particularly", "more particularly", "specifically", "more specifically" or similar terms are used in conjunction with optional features, without restricting alternative possibilities. Thus, features introduced by these terms are optional features and are not intended to restrict the scope of the claims in any way. The invention may, as the skilled person will recognize, be performed by using alternative features. Similarly, features introduced by "in an embodiment of the invention" or similar expressions are intended to be optional features, without any restriction regarding alternative embodiments of the invention, without any restrictions regarding the scope of the invention and without any restriction regarding the possibility of combining the features introduced in such way with other optional or non-optional features of the invention.

[0022] In a first aspect of the present invention, a medication delivery device for delivering a medication, specifically a liquid medication, to a user is disclosed.P39273 -EP

[0023] - 4 -

[0024] The term “medication” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a substance, specifically a chemical compound, used for treating, curing and / or preventing disease or for relieving pain, specifically in human beings. The medication may also be referred to as “medicine”. The medication may comprise at least one substance which is used in and / or administered to the user, specifically to a human being, with a view to restoring, correcting and / or modifying physiological functions by exerting a pharmacological, immunological and / or metabolic action and / or to making a diagnosis. The medication may specifically be or may comprise a liquid medication. As used herein, the term “liquid”, is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a fluid state of a substance, specifically of the medication. The liquid medication may specifically comprise a substance which itself is liquid under the delivery conditions or, alternatively, at least one substance which is dissolved, mixed and / or present in at least one liquid, such as water. For example, the liquid medication may comprise insulin. The liquid medication may specifically comprise the insulin mixed in water and, optionally, further comprising other substances, such as additives, preservatives or the like. The medication may comprise, additionally or alternatively, other antidiabetic drugs.

[0025] The term “delivery” or “delivering” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a process of administering or providing medication to a user. Specifically, the delivering of the medication to the user may comprise administering the medication to the user such that the delivered medication can be at least partially adsorbed by the user and can at least partially form part of the metabolism of the user. For example, the delivering of the medication to the user may comprise subcutaneously delivering the medication to the user, specifically such that the medication is delivered under the skin and to a body tissue of the user.

[0026] The term “medication delivery device” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers to a device config-P39273 -EP

[0027] - 5 -

[0028] ured for delivering, specifically subcutaneously delivering, the medication to the user. Additionally or alternatively, the medication delivery device may comprise one or more disposable components to ensure the continuous delivery of the medication. For example, the medication delivery device may comprise at least one disposable reservoir and / or at least one disposable infusion mechanism. The medication delivery device may further comprise at least one adhesive component for mounting the medication delivery device onto a surface of the user, such as onto a skin of the user. For example, the adhesive component may be or may comprise at least one transdermal patch. Thus, the medication delivery device may also be referred as “patch pump”.

[0029] The medication delivery device may specifically be an insulin pump. The term “insulin pump” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to device for administering insulin from at least one insulin reservoir to a user.

[0030] The term “user” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a human being or an animal, independent from the fact that the human being or animal, respectively, may be in a healthy condition or may suffer from one or more diseases. As an example, the user or the patient may be a human being or an animal suffering from diabetes. However, additionally or alternatively, the invention may be applied to other types of users, patients or diseases. In particular, the user may also be a medically trained person examining a patient suffering from diabetes and / or other diseases. Specifically, the user may be or may comprise a medical healthcare person, specifically in point-of-care applications. The user, however, may also be the patient himself or herself, specifically in homecare applications. The user specifically may be a person handling one or more of the medication delivery device.

[0031] The medication delivery device comprises:

[0032] - at least one actuator configured for rotating at least one actuator shaft;

[0033] - at least one transmission mechanism, wherein the transmission mechanism comprises at least one transmission output shaft that is configured to be coupled to a dispensing element, wherein the transmission mechanism is configured for transmitting rotational movements of the actuator shaft to the transmission output shaft for advancing theP39273 -EP

[0034] - 6 -

[0035] dispensing element for dispensing liquid out of a reservoir of the medication delivery device;

[0036] - at least one first angle sensor configured for determining at least one first rotational movement of the actuator shaft;

[0037] - at least one second angle sensor configured for determining at least one second rotational movement of the transmission output shaft; and

[0038] - at least one controller configured for determining a dysfunctional deviation between the first rotational movement of the actuator shaft and the second rotational movement of the transmission output shaft.

[0039] The medication delivery device can further comprise at least one reservoir configured for storing the medication, specifically the liquid medication, wherein the dispensing element comprises at least one plunger movably arranged within the reservoir, wherein the plunger is configured for dispensing the medication out of the reservoir, and wherein the plunger is coupled to the at least one transmission output shaft of the at least one transmission mechanism. The at least one reservoir and the at least one plunger movably arranged within the reservoir can be part of a disposable cartridge unit that can be operationally coupled and decoupled to a durable medical delivery device unit comprising the other elements as listed above. When operationally coupled to the transmission output shaft, the plunger can be moved within the reservoir by means of the at least one actuator and the at least one transmission mechanism.

[0040] The term “reservoir” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a hollow element or container which may fully or partially be fillable with a medication, specifically with a liquid medication. As an example, the reservoir may be fillable with insulin. The reservoir may be removably disposed in the medication delivery device. The reservoir may be configured for releasing the medication, specifically the liquid medication, to the user, such as via at least one infusion cannula. The reservoir may comprise at least one cartridge or vial. The vial may have a cylindrical shape. The reservoir may be a vial, specifically a rigid vial. The cartridge or vial may be configured for being removably disposed in the medication delivery device.

[0041] The term “dispensing element” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to aP39273 -EP

[0042] - 7 -

[0043] special or customized meaning. The term specifically may refer, without limitation, to an arbitrary movable element which, upon movement, causes a movement of a liquid, specifically of the liquid medication, wherein the liquid may be in direct or in indirect contact with the dispensing element. The dispensing element, as an example, can be a plunger and may comprise a piston. The dispensing element, as an example, may be or may comprise a moveable wall or surface, such as a front surface or front wall of a piston, specifically a moveable wall of a containment, such as, for example, a cartridge or case. The dispensing element may in particular be configured for performing a stepwise or continuous linear motion, wherein the linear motion of the dispensing element may determine rate of delivery of the medication.

[0044] The term “dispensing” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a process of removing or releasing. Specifically, the dispensing of the medication, specifically of the liquid medication, out of the reservoir may comprise partially or completely removing or releasing the medication, specifically of the liquid medication, from the reservoir. For example, the medication, specifically the liquid medication, may be partially dispensed out of the reservoir, such as to provide multiple doses of the medication from the reservoir to the user. Alternatively or additionally, the medication, specifically the liquid medication, may be completely dispensed out the reservoir, such as to provide a single dose of the medication to the user or in a last step of dispensing multiple doses.

[0045] The term “actuator” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary engine, machine or device configured for transforming energy into kinetic energy, such as for transforming mechanical energy, electrical energy or chemical energy into kinetic energy. Specifically, the actuator may be configured for transforming mechanical energy, electrical energy or chemical energy into a motion of a device. The actuator may transform the energy into a rotation or rotational movement of at least part of the actuator itself, specifically the actuator shaft. Specifically, the actuator may be configured for transforming energy from an energy source, such as from an energy source of the medication delivery device, e.g. a battery, into the rotational movement. The actuator, as an example, may be an electrically or physically powered motor, such as for example an electric motor, a pneumatic motor, a hydraulic motor, a clockwork motor or the like. However, other examples, such as a spring-driven clockwork, may also be feasible. The rotation, specifically the revolution speed of theP39273 -EP

[0046] - 8 -

[0047] rotation of the actuator, may be predetermined by the motor, e.g. by the build or construction of the motor itself, or by the amount or level of energy supplied to the motor. As an example, the actuator may comprise, specifically may be, an electric motor, specifically a stepping motor, a brushless DC electric motor, a reluctance motor or the like.

[0048] The term “rotating” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a rotational action or state. The rotating may specifically comprise driving, maintaining and / or changing a rotational state. Specifically, the actuator may be configured for driving, maintaining and / or changing a rotational state of the actuator shaft.

[0049] The term “actuator shaft” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers to an element or device configured for transmitting mechanical power, torque and / or rotation. The actuator shaft may specifically be configured for transmitting mechanical power, torque and / or rotation to other elements of the medication delivery device, specifically to the transmission output shaft via the transmission mechanism. The actuator shaft may be coupled directly and / or indirectly to the actuator such that a rotation of the actuator causes a rotational movement of the actuator shaft.

[0050] The term “transmission mechanism” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers to a mechanical element configured for transmitting movement, specifically rotational movements, from a first device or element to a second device or element, and / or vice versa. For example, the transmission mechanism may comprise at least one gearing mechanism. The term “gearing mechanism” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a mechanical system or device configured for modifying or converting a speed, a direction and / or a force of a motion, such as the speed, torque, direction and / or force of a linear or rotational movement. The gearing mechanism may convert a speed, torque, direction and / or force of the actuator's movement by using a variety of transmission elements, such as for example gears, wheels, levers, belts, toothed racks. Specifically, the gearing mechanism may comprise a combina-P39273 -EP

[0051] - 9 -

[0052] tion of transmission elements in order to convert the movement according to the requirements. For example, the gearing mechanism may be configured for converting a rotation of the actuator into a continuous linear motion of the plunger. For example, the gearing mechanism may be configured for transmitting a torsional moment provided by the actuator shaft to the plunger via the transmission output shaft for moving the plunger in the reservoir. Alternatively or additionally, the transmission mechanism may comprise at least one torsional flexible shaft for transmitting rotational movement of the actuator shaft to the transmission shaft. The flexible shaft may be a shaft with defined stiffness but no transmission or gear ratio.

[0053] Further, the transmission mechanism may be at least partially made from at least one plastic material and / or from at least one metal material. As an example, the transmission mechanism may be made from at least one thermoplastic material, such as from at least one polycarbonate, or polyoxymethylene, or the like. The transmission mechanism may have a rotational stiffness in the range of 1 to 1000 mNm / rad, specifically in the range of 10 to 500 mNm / rad, more specifically in the range of 50 to 300 mNm / rad, even more specifically is 200 mNm / rad, with respect to the transmission output shaft. Such a rotational stiffness of the transmission mechanism may advantageously enhance a difference or deviation in the rotational movements between the actuator shaft and the transmission output shaft which can be used to determine a potential dysfunctional deviation or occlusion of the medication delivery device. Specifically, these stiffness values may be advantageous for the present invention but may have other technical drawbacks, such as an increased signal -to-noise ratio. The stiffness may be chosen in accordance with a defined torque resolution and the available angle resolution of the used angle sensors.

[0054] The term “transmitting” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers to a process of passing a speed, a direction and / or a force of a motion from one element to another. Specifically, the transmitting may comprise passing a speed, a direction and / or a force of a rotational motion from the actuator shaft to the transmission output shaft. The transmitting may comprise modifying or converting a speed, a direction and / or a force of the rotational movement of the actuator shaft such that a rotational movement of the transmission output shaft is different from the rotational movement of the actuator shaft.P39273 -EP

[0055] - 10 -

[0056] The term “transmission output shaft” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers to an element or device configured for transmitting mechanical power, torque and / or rotation. The transmission output shaft may specifically be configured for transmitting mechanical power, torque and / or rotation to other elements of the medication delivery device, specifically to the plunger in the reservoir of the medication delivery device. The transmission output shaft may be coupled directly and / or indirectly to the plunger such that a rotation of the transmission output causes the plunger to move in the reservoir.

[0057] The transmission output shaft is configured to be coupled to the dispensing element. For example, the medication delivery device may comprise a removable reservoir for storing the medication, wherein the dispensing element, such as a plunger movably arranged in the reservoir, can be coupled to the transmission output shaft, e.g. upon connecting or inserting the removable reservoir to medication delivery device. The transmission output shaft may further be configured to be decoupled from the dispensing element, e.g. when removing the removable reservoir from the medication delivery device. Thus, as used herein, the term “coupled” may refer, without limitation, to a removable connection between two or more elements.

[0058] The term “rotational movement” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers to a circular movement of an object around an axis of rotation. Specifically, the rotational movement of the actuator shaft may comprise a circular movement around an axis of rotation defined by the actuator shaft, such as around an internal axis of rotation passing through a center of mass of the actuator shaft. Similarly, the rotational movement of the transmission output shaft may comprise a circular movement around an axis of rotation defined by the transmission output shaft, such as around an internal axis of rotation passing through a center of mass of the transmission output shaft. The rotational movement of the transmission output shaft may be equal or different to the rotational movement of the actuator shaft in terms of direction and / or speed, in particular depending on the transmission mechanism transmitting the rotational movement of the actuator shaft to the transmission output shaft. The rotational movement may also be referred to as “rotational motion”, “angular motion” or simply “rotation”.P39273 -EP

[0059] - 11 -

[0060] The terms “first” and “second”, as generally used herein for denoting components or elements, may be considered as nomenclature only, without numbering or ranking the named elements, without specifying an order and without excluding a possibility that several kinds of the first element and the second element may be present. Further, additional elements, such as one or more third parts or elements, may be present.

[0061] The term “angle sensor” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers to an arbitrary element or device configured for measuring at least one measurement variable indicative of an angular position or motion. Specifically, the angle sensor may be configured for converting an angular position or motion of the actuator shaft or the transmission output shaft to at least one sensor signal. The angle sensor may be or may comprise at least one rotary encoder. The angle sensor may comprise at least one of an absolute angle sensor and an incremental angle sensor. The absolute angle sensor may be configured for measuring at least one measurement variable indicative of an absolute angular position of the actuator shaft or the transmission output shaft, respectively. The relative angle sensor may be configured for measuring at least one measurement variable indicative of an angular motion, which may be typically processed in the controller into the desired angle information.

[0062] The first angle sensor may be arranged at an input of the transmission mechanism or, alternatively, directly at the actuator. The second angle sensor may be arranged at an output of the transmission mechanism.

[0063] The term “determining rotational movement” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers to a process of generating at least one representative result, in particular, by evaluating the at least one measurement signal as acquired by the angle sensor. The determining of the rotational movement may specifically comprise evaluating the detector signal as acquired by the first or second angle sensor in order to derive the rotational movement of the actuator shaft or the transmission output shaft, respectively. The first rotational movement may comprise at least one an absolute rotational movement of the actuator shaft and a relative rotational movement of actuator shaft. The second rotational movement may comprise at least one an absolute rotational movement of the transmission output shaft and a relative rotational movement of transmission output shaft.P39273 -EP

[0064] - 12 -

[0065] The first angle sensor may comprise at least one angle sensor selected from the group consisting of a photointerrupter and an impeller wheel; a rotary encoder using interruptive, reflective or light intensity measuring optical principles; a magnetic rotary encoder; an inductive rotary encoder; a capacitive rotary encoder; a potentiometric rotary encoder; an optical rotary encoder, specifically an absolute optical rotary encoder and / or an incremental optical rotary encoder; a rotary encoder based on a control signal of the motor; a rotary encoder based on the back EMF of the motor; an internal motor sensor. The first angle sensor can comprise a rotary encoder using interruptive, reflective or light intensity measuring optical principles, such as an encoder disc with a reflectivity and / or incremental pattern and / or an absolute gray coder and / or surface tracking. Thereby the first angle sensor provides a sensor value for determining at least one first rotational movement indicative of a distinct rotary position of the actuator shaft.

[0066] The second angle sensor may comprise at least one angle sensor selected from the group consisting of a photointerrupter and an impeller wheel; a rotary encoder using interruptive, reflective or light intensity measuring optical principles; a magnetic rotary encoder; an inductive rotary encoder; a capacitive rotary encoder; a potentiometric rotary encoder; an optical rotary encoder, specifically an absolute optical rotary encoder and / or an incremental optical rotary encoder. The second angle sensor can comprise a rotary encoder using interruptive, reflective or light intensity measuring optical principles, such as an encoder disc with a reflectivity and / or incremental pattern and / or an absolute gray coder and / or surface tracking. Thereby the second angle sensor provides a sensor value for determining at least one second rotational movement indicative of a distinct rotary position of the transmission output shaft.

[0067] For example, the transmission mechanism may comprise at least one actuator gear coupled to the actuator shaft and at least output gear coupled to the transmission output shaft. The term “gear” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary object configured for transmitting motion by rotating about an axis. As an example, the gear may be a toothed wheel, a worm, a friction wheel or the like. The gear may be configured for transmitting motion using various transfer mechanisms, such as traction or positive locking, for example by interlocking or meshing teeth. The rotational movements of the actuator shaft may be transmitted to the transmission output shaft via interaction of the actuator gear withP39273 -EP

[0068] - 13 -

[0069] the output gear. Optionally, the transmission mechanism may comprise at least one further intermediate gear arranged in between the actuator gear and the output gear, specifically such that a direction of rotation of the transmission output shaft is equal to a direction of rotation of the actuator gear. For example, the actuator gear provides a gear ratio converting the rotation of the actuator having a first rotational speed into a rotation of the transmission output shaft having a second rotational speed. The rotation of the transmission output shaft having a second rotational speed different than the first rotational speed of the actuator can further be converted into a linear movement. In this example, the second angle sensor may comprise at least one optical rotary encoder configured for optically detecting the at least one second rotational movement of the transmission output shaft by tracking a surface movement of the output gear. The optical rotary encoder may specifically be configured for precisely detecting the second rotational movement of the transmission output shaft by tracking the surface movement of the structured surface of the output gear.

[0070] Thus, as an example, the second angle sensor may comprise at least one optical rotary encoder configured for optically detecting the at least one second rotational movement of the transmission output shaft and the first angle sensor may comprise at least one magnetic rotary encoder configured for generating absolute angle and direction information.

[0071] The term “dysfunctional operation” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically refers to a state of a device of being defective or malfunctioning. Specifically, the dysfunctional operation may be a state of the medication delivery device of being defective or malfunctioning. The dysfunctional operation may be a state of the medication delivery device in which the delivery of the medication, specifically of the liquid medication, to the user is hindered or completely blocked. For example, the dysfunctional operation may be a state of the medication delivery device in which a given or predetermined rotational movement of the actuator shaft driven by the actuator and associated with an intended target amount of medication delivered from the reservoir to the user causes a reduced actual amount medication delivered from the reservoir to the user. Alternatively or additionally, the dysfunctional operation may be a state of the medication delivery device in which a rotational movement of the actuator shaft driven by the actuator causes no medication delivered from the reservoir to the user, and, thus, may be in a state of an occlusion. In both cases, the dysfunctional deviation between the first rotational movement and the second rotational movement may be determined at the medication delivery device and, thus, the medication delivery device has a dysfunctional operation. TheP39273 -EP

[0072] - 14 -

[0073] determining of the dysfunctional operation of the medication delivery device may specifically comprise determining a presence or an absence of the dysfunctional operation of the medication delivery device.

[0074] The dysfunctional deviation between the first rotational movement of the actuator shaft and the second rotational movement of the transmission output shaft may be indicative of at least one of an occlusion of the medication delivery device; a dysfunctional resistance of the medication delivery device; a dysfunctional forward resistance of the medication delivery device; a dysfunctional rotational resistance of the medication delivery device. For example, the controller may specifically be configured for determining a difference between the first rotational movement detected by the first angle sensor and the second rotational movement detected by the second angle sensor. The controller may further be configured to determine an occlusion of the medication delivery device based on the difference between the first and second rotational movements. However, other characteristics or indication numbers for determining an occlusion or a malfunctioning or dysfunctioning of the medication delivery device may also be feasible. For example, it may also be possible to determine a ratio between the first rotational movement detected by the first angle sensor and the second rotational movement detected by the second angle sensor and to determine the occlusion of the medication delivery device based on the ratio.

[0075] The controller may be configured for determining at least one first rotation angle cpmotof the actuator shaft using the first rotational movement. The controller may further be configured for determining at least one second rotation angle cpoutof the transmission output shaft using the second rotational movement. The controller may further be configured for determining an effective torsional moment T at the transmission output shaft according to:

[0076] T — b I (P111011I

[0077] * ^out I T*out b

[0078]

[0079] \Lg /

[0080] wherein koutdenotes a rotational stiffness of the transmission mechanism and igdenotes a total transmission ratio of the transmission mechanism with respect to the transmission output shaft.

[0081] The controller may be configured for determining the dysfunctional deviation between the first rotational movement of the actuator shaft and the second rotational movement of the transmission output shaft in case the effective torsional moment exceeds at least one dysfunction threshold, specifically for a predetermined number of times and / or for a predeter-P39273 -EP

[0082] mined time interval. The controller may specifically be configured for determining the dysfunctional deviation if T > TDYS, wherein TDYSdenotes the dysfunctional deviation threshold. For example, the controller may be configured for determining the dysfunctional deviation in case the effective torsional moment exceeds at least one dysfunctional deviation threshold for at least 10 of the previous dosing movements. Alternatively or additionally, the controller may be configured for determining the dysfunctional deviation in case the effective torsional moment exceeds at least one dysfunctional deviation threshold for a predetermined time interval. The predetermined time interval may depend on a maximum output per unit of time, or more generally on a maximum delivery speed of the medication delivery device. The predetermined time interval may be based on the maximum error tolerance time, which is derived from the maximum medically non-critical incorrect amount of insulin.

[0083] Alternatively or additionally, the controller may be configured for monitoring functioning of the medication delivery device by comparing the first rotation angle cpmotof the actuator shaft and the second rotation angle cpoutof the transmission output shaft, e.g. via

[0084] (Pmot

[0085] T*out < threshold,

[0086]

[0087] Thus, by using the first rotational movement for determining the first rotation angle cpmotof the actuator shaft and the second rotational movement for determining the second rotation angle cpoutof the transmission output shaft, the controller may achieve a diverse redundancy for monitoring and / or controlling proper functioning of the medication delivery device.

[0088] Further, the controller may be configured for performing at least one priming test comprising determining at least one initial rotational movement of the actuator shaft and at least one initial rotational movement of the transmission output shaft with an open medication delivery device. The priming test may specifically be part of a manufacturing process of the medication delivery device, e.g. as an end-of-line test or the like, or may be performed at a user site, e.g. upon initial operation of the medication delivery device or at a change of the reservoir. The priming test may specifically be performed with the reservoir being at least partially filled with the medication, specifically with the liquid medication. The priming test may comprise determining at least one of a calibration of the first rotational movement of the actuator shaft and the second rotational movement of the transmission output shaft; a friction of the transmission mechanism; an error of the transmission mechanism; a determination of system parameter and a comparison to old values or against a predefined threshold or against values determined in the production line and saved in the medication deliveryP39273 -EP

[0089] - 16 -

[0090] device, specifically in a storage device of the medication delivery device, e.g. in a ROM; a plausibility check for at least one of the first angle sensor and the second angle sensor comprising checking if signals are readable and make sense, etc.; a plausibility check for the actuator, e.g. comprising a check if the actuator is turning in the right direction, etc.

[0091] In a further aspect of the present invention, a method is disclosed, for determining a dysfunctional operation of a medication delivery device according to the present invention, such as according to any one of the embodiments disclosed above and / or according to any one of the embodiments disclosed in further detail below. Specifically, the method may be performed on a medication delivery device according to the present invention, such as according to any one of the embodiments disclosed above and / or according to any one of the embodiments disclosed in further detail below.

[0092] The method comprises the following steps, which, as an example, may be performed in the given order. It shall be noted, however, that a different order is also possible. Further, it is possible to perform one or more or even all of the method steps once or repeatedly. Further, it is possible to perform two or more of the method steps simultaneously or in a timely overlapping fashion. The method may comprise additional method steps, which are not listed.

[0093] The method comprises the following steps:

[0094] a) driving the actuator to move the dispensing element via the transmission output shaft of the transmission mechanism to dispense medication, specifically liquid medication, out of a reservoir of the medication delivery device;

[0095] b) determining a first rotational movement of the actuator shaft by using the first angle sensor;

[0096] c) determining a second rotational movement of the transmission output shaft by using the second angle sensor; and

[0097] d) determining, by using the controller, a dysfunctional deviation between the first rotational movement of the actuator shaft and the second rotational movement of the transmission output shaft .

[0098] The method may specifically comprise using the at least one medication delivery device, specifically without having the medication delivery device applied to the user. Thus, in this example, the dispensing of the medication out of the reservoir may not comprise a delivery of the medication to the user. Alternatively, the method may also be performed after application of the medication delivery device to the user.P39273 -EP

[0099] - 17 -

[0100] The determining of the dysfunctional deviation may comprise determining at least one first rotation angle cpmotof the actuator shaft using the first rotational movement, and at least one second rotation angle cpoutof the transmission output shaft. Further, the method may comprise determining an effective torsional moment T at the transmission output shaft according to:

[0101] T — b I (P111011I

[0102] * ^out I j (Pout b

[0103]

[0104] wherein koutdenotes a rotational stiffness of the transmission mechanism and igdenotes a total transmission ratio of the transmission mechanism with respect to the transmission output shaft.

[0105] The dysfunctional deviation between the first rotational movement of the actuator shaft and the second rotational movement of the transmission output shaft may be determined in case the effective torsional moment exceeds at least one dysfunctional deviation threshold, specifically for a predetermined number of times and / or for a predetermined time interval.

[0106] Alternatively or additionally, the method may further comprise, specifically prior to step a), performing at least one priming test comprising determining at least one initial rotational movement of the actuator shaft and at least one initial rotational movement of the transmission output shaft with an open medication delivery device. The priming test may comprise determining at least one of: a calibration of the first rotational movement of the actuator shaft and the second rotational movement of the transmission output shaft; a friction of the transmission mechanism; an error of the transmission mechanism; a determination of system parameter and a comparison to old values or against a predefined threshold or against values determined in the production line and saved in the medication delivery device, specifically in a storage device of the medication delivery device, e.g. in a ROM; a plausibility check for at least one of the first angle sensor and the second angle sensor comprising checking if signals are readable and make sense, etc.; a plausibility check for the actuator, e.g. comprising a check if the actuator is turning in the right direction, etc.

[0107] Alternatively or additionally, the determining of the dysfunctional deviation between the first rotational movement of the actuator shaft and the second rotational movement of the transmission output shaft of the medication delivery device may comprise determining a presence or an absence of an occlusion of the medication delivery device.P39273 -EP

[0108] - 18 -

[0109] Alternatively or additionally, the method may be computer-controlled. The term “computer-controlled” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a method involving at least one computing unit. The computing unit may be part of a computer and / or computer network or, alternatively, of the medication delivery device itself, and may comprise at least one processor which is configured for performing and / or controlling performing at least one of the method steps of the method according to the present invention. Specifically, each of the method steps is performed and / or controlled by the computing unit. The method may be performed completely automatically, specifically without user interaction.

[0110] In a further aspect of the present invention, a computer program is disclosed, comprising instructions which, when the program is executed by the medication delivery device according to the present invention, such as according to any one of the embodiments disclosed above and / or according to any one of the embodiments disclosed in further detail below, cause the medication delivery device to perform the method according to the present invention, such as according to any one of the embodiments disclosed above and / or according to any one of the embodiments disclosed in further detail below.

[0111] In a further aspect of the present invention, a computer-readable storage medium, specifically a non-transient computer-readable medium, is disclosed, comprising instructions which, when the instructions are executed by the medication delivery device according to the present invention, such as according to any one of the embodiments disclosed above and / or according to any one of the embodiments disclosed in further detail below, cause the medication delivery device to perform the method according to the present invention, such as according to any one of the embodiments disclosed above and / or according to any one of the embodiments disclosed in further detail below.

[0112] As used herein, the term “computer-readable storage medium” specifically may refer to non-transitory data storage means, such as a hardware storage medium having stored thereon computer-executable instructions. The computer-readable storage medium specifically may be or may comprise a storage medium such as a random-access memory (RAM) and / or a read-only memory (ROM). The computer-readable storage medium may also be referred to as “computer-readable data carrier”.P39273 -EP

[0113] - 19 -

[0114] Referring to the computer-implemented aspects of the invention, one or more of the method steps or even all of the method steps of the method according to one or more of the embodiments disclosed herein may be performed and / or controlled by using a computing unit. Thus, generally, any of the method steps including provision and / or manipulation of data may be performed by using the computing unit. Generally, these method steps may include any of the method steps, typically except for method steps requiring manual work, such as providing the samples and / or certain aspects of performing the actual measurements.

[0115] The medication delivery device and the method according present invention may provide a large number of advantages over known methods and devices. The present invention may comprise determining a rotation of the actuator shaft by the first angle sensor, determining a rotation of the transmission output shaft by the second angle sensor and comparing the rotation of the actuator shaft with the rotation of the transmission output shaft in order to detect an occlusion at the medication delivery device. Thus, specifically, the medication delivery device and the method according present invention may provide a precise, fast and reliable occlusion detection via the two angle sensors.

[0116] The medication delivery device may specifically comprise a drive system comprising dual angle sensors. The first angle sensor may be arranged at an input of the transmission mechanism or directly at the actuator. The second angle sensor may be arranged at an output of the transmission mechanism. The actuator may be an arbitrary actuator, such as an electrical motor or the like. By using the first and second angle sensors, the present invention may provide an occlusion detection, e.g. via a determination of a drive torque using the angle signals in front of the transmission mechanism and after the transmission mechanism. The transmission mechanism may have a known total transmission ratio ig. The rotational stiffness k of the transmission mechanism may be predetermined, such as via measurement or numerical simulation using a finite element method. The occlusion may be detected by determining the first angle cpmotat the actuator and the second angle cpoutat the output of the transmission mechanism and comparing the two angles with each other.

[0117] The angle sensors may provide either absolute or relative angle information. Thus, in particular, incremental methods or sensors may be suitable for the present invention. In case of relative angle information, a referencing may be performed relating the angle information from the first angle sensor to the angle information from the second angle sensor, e.g. during manufacturing of the medication delivery device and / or during a priming operation of the medication delivery device that is carried out after replacement of the reservoir.P39273 -EP

[0118] - 20 -

[0119] In principle, a rotatory system having two degrees of freedom may be described by:

[0120] „ > „ I <Pmot .. i i i, | <Pmot . | I 7 | (Pmot \ ' '-'out I <Pout I "b D0Uf I T <Pout I ”b K-out I T*out )•

[0121]

[0122] In the quasi-static case, i.e. if the inertia of the actuator and the damping is neglectable, the torsional moment may be determined according to the following equation:

[0123] T — b I (P111011I

[0124] ' ^out I (Pout ]•

[0125]

[0126] This equation may allow determining an effective torsional moment using the first and second rotational movements determined by the first and second angle sensors, respectively. The effective torsional moment may be used for comparing with the occlusion threshold Toccto detect an occlusion at the medication delivery device. For example, an occlusion of the medication delivery device may be likely determined in case T > Tocc. Additionally or alternatively, the occlusion may be determined in case the occlusion threshold is exceeded for a number of predetermined times or a predetermined time interval. Thus, the occlusion may not be indicated to the user if the occlusion threshold is exceed for the first time but only if the occlusion threshold is exceeded repeatedly or permanently. For example, the occlusion may be detected in case the occlusion threshold is exceeded at least 10 times of the previous dosing movements. Thus, the occlusion detection may be reliable and fail-safe.

[0127] The medication delivery device comprises the at least one first angle sensor, wherein, specifically, the first angle sensor may be configured for determining a rotation of the actuator cpmot- Further, the medication delivery device comprises the at least one second angle sensor, wherein, specifically, the second angle sensor may comprise an optical rotary encoder configured for determining a rotation of the transmission output shaft cpoutvia a detection of a surface structure at the transmission output shaft, e.g. at an output gear. The transmission mechanism may specifically be made of a plastic material and may have a rotational stiffness of preferably 200 mNm / rad at the output of the transmission mechanism. Thus, such a low rotational stiffness may advantageously enhance a potential difference in rotational movement of the actuator shaft compared with the transmission output shaft and, thus, may enhance precision of the occlusion detection.

[0128] After filling of the reservoir, a priming test may be performed with the medication delivery device. The priming test may comprise resetting the sensor signals of the first and secondP39273 -EP

[0129] - 21 -

[0130] angle sensor. During priming, a small and constant load may be applied to the system. The priming test may also comprise removing possible bearing gaps in the system. The priming test may further comprise determining a friction of the transmission mechanism and / or an error of the transmission mechanism via a range of variation, optionally combined with a factor analysis of the components of the transmission mechanism. The priming test may enhance precision of the occlusion detection since any effects of frication and / or errors in the transmission mechanism are known or determined.

[0131] The medication delivery device may also have advantages in the manufacturing process. Specifically, the second angle sensor may be used for monitoring and correcting production of the transmission mechanism, e.g. via detection and correction of errors in the transmission mechanism or different friction in the delivery state. Further, the second angle sensor may render any angle references redundant. Thus, no additional measurements or information regarding the angle at the transmission output shaft may be necessary. The second angle sensor, in combination with the first angle, may be sufficient to detect the angle and evaluate the torsional moment

[0132] In order to evaluate and enhance precision of torsional moment detection, a defined load may be applied to the medication delivery device. The torsional moment as determined by the controller may be compared with the externally applied load and may be adapted if required. For example, a switchable dynamometer may be used to calibrate the torsional moment. This approach may facilitate the manufacturing process since external references or additional measurement become redundant.

[0133] Summarizing and without excluding further possible embodiments, the following embodiments may be envisaged:

[0134] Embodiment 1 : A medication delivery device for delivering a medication, specifically a liquid medication, to a user, the medication delivery device comprising:

[0135] - at least one actuator configured for rotating at least one actuator shaft;

[0136] - at least one transmission mechanism, wherein the transmission mechanism comprises at least one transmission output shaft that is configured to be coupled to a dispensing element, wherein the transmission mechanism is configured for transmitting rotational movements of the actuator shaft to the transmission output shaft for advancing the dispensing element for dispensing liquid out of a reservoir of the medication delivery device;P39273 -EP

[0137] - 22 -

[0138] - at least one first angle sensor configured for determining at least one first rotational movement of the actuator shaft;

[0139] - at least one second angle sensor configured for determining at least one second rotational movement of the transmission output shaft; and

[0140] - at least one controller configured for determining a dysfunctional deviation between the first rotational movement of the actuator shaft and the second rotational movement of the transmission output shaft.

[0141] Embodiment 2: The medication delivery device according to the preceding embodiment, wherein the dysfunctional deviation between the first rotational movement of the actuator shaft and the second rotational movement of the transmission output shaft is indicative of at least one of: an occlusion of the medication delivery device; a dysfunctional resistance of the medication delivery device; a dysfunctional forward resistance of the medication delivery device; a dysfunctional rotational resistance of the medication delivery device.

[0142] Embodiment 3 : The medication delivery device according to any one of the preceding embodiments, wherein the first rotational movement comprises at least one an absolute rotational movement of the actuator shaft and a relative rotational movement of actuator shaft.

[0143] Embodiment 4: The medication delivery device according to any one of the preceding embodiments, wherein the second rotational movement comprises at least one an absolute rotational movement of the transmission output shaft and a relative rotational movement of transmission output shaft.

[0144] Embodiment 5: The medication delivery device according to any one of the preceding embodiments, wherein the first angle sensor comprises at least one angle sensor selected from the group consisting of a photointerrupter and an impeller wheel; a rotary encoder using interruptive, reflective or light intensity measuring optical principles; a magnetic rotary encoder; an inductive rotary encoder; a capacitive rotary encoder; a potentiometric rotary encoder; an optical rotary encoder, specifically an absolute optical rotary encoder and / or an incremental optical rotary encoder; a rotary encoder based on a control signal of the motor; a rotary encoder based on the back EMF of the motor; an internal motor sensor.P39273 -EP

[0145] - 23 -

[0146] Embodiment 6: The medication delivery device according to any one of the preceding embodiments, wherein the second angle sensor comprises at least one angle sensor selected from the group consisting of: a photointerrupter and an impeller wheel; a rotary encoder using interruptive, reflective or light intensity measuring optical principles; a magnetic rotary encoder; an inductive rotary encoder; a capacitive rotary encoder; a potentiometric rotary encoder; an optical rotary encoder, specifically an absolute optical rotary encoder and / or an incremental optical rotary encoder.

[0147] Embodiment 7: The medication delivery device according to any one of the preceding embodiments, wherein the transmission mechanism comprises at least one actuator gear coupled to the actuator shaft and at least output gear coupled to the transmission output shaft, wherein the rotational movements of the actuator shaft is transmitted to the transmission output shaft via interaction of the actuator gear with the output gear.

[0148] Embodiment 8: The medication delivery device according to the preceding embodiment, wherein the second angle sensor comprises at least one optical rotary encoder configured for optically detecting the at least one second rotational movement of the transmission output shaft by tracking a surface movement of the output gear.

[0149] Embodiment 9: The medication delivery device according to any one of the preceding embodiments, wherein the controller is configured for determining at least one first rotation angle <pmotof the actuator shaft using the first rotational movement, wherein the controller is further configured for determining at least one second rotation angle <poutof the transmission output shaft using the second rotational movement.

[0150] Embodiment 10: The medication delivery device according to the preceding embodiment, wherein the controller is further configured for determining an effective torsional moment T at the transmission output shaft according to:

[0151] T — b I (P111011I

[0152] * ^out I T*out b

[0153]

[0154] \Lg /

[0155] wherein koutdenotes a rotational stiffness of the transmission mechanism and igdenotes a total transmission ratio of the transmission mechanism with respect to the transmission output shaft.P39273 -EP

[0156] - 24 -

[0157] Embodiment 11 : The medication delivery device according to the preceding embodiment, wherein the controller is configured for determining the dysfunctional deviation between the first rotational movement of the actuator shaft and the second rotational movement of the transmission output shaft in case the effective torsional moment exceeds at least one dysfunctional deviation threshold, specifically for a predetermined number of times and / or for a predetermined time interval.

[0158] Embodiment 12: The medication delivery device according to any one of the preceding embodiments, wherein the controller is configured for performing at least one priming test comprising determining at least one initial rotational movement of the actuator shaft and at least one initial rotational movement of the transmission output shaft with an open medication delivery device.

[0159] Embodiment 13: The medication delivery device according to the preceding embodiment, wherein the priming test comprises determining at least one of: a calibration of the first rotational movement of the actuator shaft and the second rotational movement of the transmission output shaft; a friction of the transmission mechanism; an error of the transmission mechanism; a determination of system parameter and a comparison to old values or against a predefined threshold or against values determined in the production line and saved in the medication delivery device, specifically in a storage device of the medication delivery device, e.g. in a ROM; a plausibility check for at least one of the first angle sensor and the second angle sensor comprising checking if signals are readable and make sense, etc.; a plausibility check for the actuator, e.g. comprising a check if the actuator is turning in the right direction, etc.

[0160] Embodiment 14: The medication delivery device according to any one of the preceding embodiments, wherein the transmission mechanism is at least partially made from at least one plastic material and / or from at least one metal material.

[0161] Embodiment 15: The medication delivery device according to any one of the preceding embodiments, wherein the transmission mechanism has a rotational stiffness in the range of 1 to 1000 mNm / rad, specifically in the range of 10 to 500 mNm / rad, more specifically in the range of 50 to 300 mNm / rad, even more specifically is 200 mNm / rad, with respect to the transmission output shaft.P39273 -EP

[0162] - 25 -

[0163] Embodiment 16: The medication delivery device according to any one of the preceding embodiments, wherein the transmission mechanism is configured for transmitting a torsional moment provided by the actuator shaft to the plunger via the transmission output shaft for moving the plunger in the reservoir.

[0164] Embodiment 17: The medication delivery device according to any one of the preceding embodiments, wherein the actuator comprises, specifically is, an electric motor, specifically a stepping motor, a brushless DC electric motor and / or a reluctance motor.

[0165] Embodiment 18: The medication delivery device according to any one of the preceding embodiments, wherein the movement of the plunger in the reservoir causes the dispensing of the medication out of the reservoir.

[0166] Embodiment 19: The medication delivery device according to any one of the preceding embodiments, wherein the medication delivery device is an insulin pump.

[0167] Embodiment 20: The medication delivery device according to any one of the preceding embodiments, wherein the determining of the occlusion of the medication delivery device comprises determining a presence or an absence of the occlusion of the medication delivery device.

[0168] Embodiment 21 : The medication delivery device according to any one of the preceding embodiments, wherein the medication delivery device further comprises at least one reservoir configured for storing the medication, wherein the dispensing element comprises at least one plunger that is movably arranged within the reservoir, wherein the plunger is configured for dispensing the medication out of the reservoir, and wherein the plunger is coupled to the at least one transmission output shaft of the transmission mechanism.

[0169] Embodiment 22: A method for determining a dysfunctional operation of a medication delivery device according to any one of the preceding embodiments, wherein the method comprises the following steps:

[0170] a) driving the actuator to move the dispensing element via the transmission output shaft of the transmission mechanism to dispense medication, specifically liquid medication, out of a reservoir of the medication delivery device;P39273 -EP

[0171] - 26 -

[0172] b) determining a first rotational movement of the actuator shaft by using the first angle sensor;

[0173] c) determining a second rotational movement of the transmission output shaft by using the second angle sensor; and

[0174] d) determining, by using the controller, a dysfunctional deviation between the first rotational movement of the actuator shaft and the second rotational movement of the transmission output shaft.

[0175] Embodiment 23 : The method according to the preceding embodiment, wherein the determining of the dysfunctional deviation comprises determining at least one first rotation angle cpmotof the actuator shaft using the first rotational movement, and at least one second rotation angle cpoutof the transmission output shaft.

[0176] Embodiment 24: The method according to the preceding embodiment, further comprising determining an effective torsional moment T at the transmission output shaft according to:

[0177] T — b I (P111011I

[0178] * ^out I T*out b

[0179]

[0180] \Lg /

[0181] wherein koutdenotes a rotational stiffness of the transmission mechanism and igdenotes a total gear transmission of the transmission mechanism with respect to the transmission output shaft.

[0182] Embodiment 25: The method according to the preceding embodiment, wherein the dysfunctional deviation between the first rotational movement of the actuator shaft and the second rotational movement of the transmission output shaft is determined in case the effective torsional moment exceeds at least one dysfunctional deviation threshold, specifically for a predetermined number of times and / or for a predetermined time interval.

[0183] Embodiment 26: The method according to any one of the preceding method embodiments, wherein the method further comprises, specifically prior to step a), performing at least one priming test comprising determining at least one initial rotational movement of the actuator shaft and at least one initial rotational movement of the transmission output shaft with an open medication delivery device.P39273 -EP

[0184] - 27 -

[0185] Embodiment 27: The method according to the preceding embodiment, wherein the priming test comprises determining at least one of: a calibration of the first rotational movement of the actuator shaft and the second rotational movement of the transmission output shaft; a friction of the transmission mechanism; an error of the transmission mechanism; a determination of system parameter and a comparison to old values or against a predefined threshold or against values determined in the production line and saved in the medication delivery device, specifically in a storage device of the medication delivery device, e.g. in a ROM; a plausibility check for at least one of the first angle sensor and the second angle sensor comprising checking if signals are readable and make sense, etc.; a plausibility check for the actuator, e.g. comprising a check if the actuator is turning in the right direction, etc.

[0186] Embodiment 28: The method according to any one of the preceding method embodiments, wherein the determining of the dysfunctional deviation between the first rotational movement of the actuator shaft and the second rotational movement of the transmission output shaft comprises determining a presence or an absence of an occlusion of the medication delivery device.

[0187] Embodiment 29: The method according to anyone of the preceding method embodiments, wherein the method is computer-controlled.

[0188] Embodiment 30: The method according to any one of the preceding method embodiments, wherein the method comprising using the at least one medication delivery device, specifically without having the medication delivery device applied to the user.

[0189] Embodiment 31 : A computer program comprising instructions which, when the program is executed by the medication delivery device according to any one of the preceding embodiments referring to a medication delivery device, cause the medication delivery device to perform the method according to any one of the preceding embodiments referring to a method.

[0190] Embodiment 32: A computer-readable storage medium, specifically a non-transient computer-readable medium, comprising instructions which, when the instructions are executed by the medication delivery device according to any one of the preceding embodiments referring to a medication delivery device, cause the medication deliveryP39273 -EP

[0191] - 28 -

[0192] device to perform the method according to any one of the preceding embodiments referring to a method.

[0193] Short description of the Figures

[0194] Further optional features and embodiments will be disclosed in more detail in the subsequent description of embodiments, preferably in conjunction with the dependent claims. Therein, the respective optional features may be realized in an isolated fashion as well as in any arbitrary feasible combination, as the skilled person will realize. The scope of the invention is not restricted by the preferred embodiments. The embodiments are schematically depicted in the Figures. Therein, identical reference numbers in these Figures refer to identical or functionally comparable elements.

[0195] In the Figures:

[0196] Figure 1 A shows an embodiment of a medication delivery device in a schematic view;

[0197] Figure IB shows the actuator and the transmission mechanism of the medication delivery device of Figure 1A in a perspective view;

[0198] Figure 2 shows a flow chart of a method for determining occlusion dysfunctional operation of a medication delivery device; and

[0199] Figure 3 shows a diagram of a simulation of the effective torsional moment T at the transmission output shaft.

[0200] Detailed description of the embodiments

[0201] Figure 1 A shows an exemplary embodiment of a medication delivery device 110 delivering a medication, specifically a liquid medication, to a user in a schematic view. The medication delivery device 110 may, as an example, be an insulin pump 112.

[0202] The medication delivery device 110 may, in this example, comprise at least one reservoir 114 configured for storing the medication, specifically the liquid medication, and at leastP39273 -EP

[0203] - 29 -

[0204] one plunger 116 movably arranged within the reservoir 114, wherein the plunger 116 is configured for dispensing the medication out of the reservoir 114.

[0205] The medication delivery device 110 comprises at least one actuator 118 configured for rotating at least one actuator shaft 120. For example, the actuator 118 may be an electric motor 122, specifically a stepping motor, a brushless DC electric motor and / or a reluctance motor. However, other examples, such as a pneumatic motor, a hydraulic motor, a clockwork motor, a spring-driven clockwork or the like, may also be feasible.

[0206] The medication delivery device 110 further comprises at least one transmission mechanism 124. The transmission mechanism 124 comprises at least one transmission output shaft 126 that is configured to be coupled to a dispensing element, in this example to the plunger 116. The transmission mechanism 124 is configured for transmitting rotational movements of the actuator shaft 120 to the transmission output shaft 126 for advancing the dispensing element for dispensing liquid out of the reservoir 114 of the medication delivery device 110. An exemplary embodiment of the transmission mechanism 124 is shown in more detail in the perspective view of Figure IB. Thus, for a detailed description of the transmission mechanism 124, reference is made to the description of Figure IB.

[0207] Further, as shown in Figure 1A, the medication delivery device 110 comprises at least one first angle sensor 128 configured for determining at least one first rotational movement of the actuator shaft 120 and at least one second angle sensor 130 configured for determining at least one second rotational movement of the transmission output shaft 126.

[0208] The first angle sensor 128 may comprise at least one angle sensor selected from the group consisting of a photointerrupter and an impeller wheel; a rotary encoder using interruptive, reflective or light intensity measuring optical principles; a magnetic rotary encoder; an inductive rotary encoder; a capacitive rotary encoder; a potentiometric rotary encoder; an optical rotary encoder, specifically an absolute optical rotary encoder and / or an incremental optical rotary encoder; a rotary encoder based on a control signal of the motor; a rotary encoder based on the back EMF of the motor; an internal motor sensor.

[0209] The second angle sensor 130 may comprise at least one angle sensor selected from the group consisting of a photointerrupter and an impeller wheel; a rotary encoder using interruptive, reflective or light intensity measuring optical principles; a magnetic rotary encoder; an in-P39273 -EP

[0210] - 30 -

[0211] ductive rotary encoder; a capacitive rotary encoder; a potentiometric rotary encoder; an optical rotary encoder, specifically an absolute optical rotary encoder and / or an incremental optical rotary encoder.

[0212] Further, the medication delivery device 110 comprises at least one controller 132 configured for determining a dysfunctional deviation between the first rotational movement of the actuator shaft 120 and the second rotational movement of the transmission output shaft 126. As can be seen in Figure 1A, the controller 132 may be communicatively coupled to the first angle sensor 128 and the second angle sensor 130, such as via a wired communication path and / or via a wireless connection communication path. Thus, the first angle sensor 128 and the second angle sensor 130 may be configured for communicating the first rotational movement of the actuator shaft 120 and the second rotational movement of the transmission output shaft 126 to the controller 132. Further, as indicated by the arrow in Figure 1 A, the controller 132 may also be configured for controlling operation of the actuator 118.

[0213] The controller 132 may be configured for determining at least one first rotation angle cpmotof the actuator shaft 120 using the first rotational movement. The controller 132 may further be configured for determining at least one second rotation angle cpoutof the transmission output shaft 126 using the second rotational movement. The controller 132 may further be configured for determining an effective torsional moment T at the transmission output shaft 126 according to:

[0214] T — b I (P111011I

[0215] * ^out I T*out b

[0216]

[0217] \Lg /

[0218] wherein koutdenotes a rotational stiffness of the transmission mechanism 124 and igdenotes a total transmission ratio of the transmission mechanism 124 with respect to the transmission output shaft 126.

[0219] The controller 132 may be configured for determining the dysfunctional deviation between the first rotational movement of the actuator shaft 120 and the second rotational movement of the transmission output shaft 126 in case the effective torsional moment exceeds at least one dysfunctional deviation threshold, specifically for a predetermined number of times and / or for a predetermined time interval. The controller 132 may specifically be configured for determining the dysfunctional deviation if T > TDYS, wherein TDYSdenotes the dysfunctional deviation threshold. For example, the controller 132 may be configured for determining the dysfunctional deviation in case the effective torsional moment exceeds at least oneP39273 -EP

[0220] - 31 -

[0221] dysfunctional deviation threshold for at least 10 of the previous dosing movements. Alternatively or additionally, the controller 132 may be configured for determining the dysfunctional deviation in case the effective torsional moment exceeds at least one dysfunctional deviation threshold for a predetermined time interval. The predetermined time interval may depend on a maximum output per unit of time, or more generally on a maximum delivery speed of the medication delivery device. The predetermined time interval may be based on the maximum error tolerance time, which is derived from the maximum medically non-crit-ical incorrect amount of insulin.

[0222] Figure IB shows a more detailed view on the actuator 118 and the transmission mechanism 124 of the medication delivery device 110 of Figure 1 A in a perspective view. As shown in Figure IB, the transmission mechanism 124 may comprise at least one actuator gear 134 coupled to the actuator shaft 120 and at least output gear 136 coupled to the transmission output shaft 126. The rotational movements of the actuator shaft 120 may be transmitted to the transmission output shaft 126 via interaction of the actuator gear 134 with the output gear 136. Further, in this example, the transmission mechanism 124 may comprise at least one further intermediate gear 138 arranged in between the actuator gear 134 and the output gear 136, specifically such that a direction of rotation of the transmission output shaft 126 is equal to a direction of rotation of the actuator gear 134. In this example, the second angle sensor 130 may comprise at least one optical rotary encoder configured for optically detecting the at least one second rotational movement of the transmission output 126 shaft by tracking a surface movement of the output gear 136. The optical rotary encoder may specifically be configured for precisely detecting the second rotational movement of the transmission output shaft 126 by tracking the surface movement of the structured surface of the output gear 136.

[0223] Thus, in the exemplary embodiment of Figure IB, the second angle sensor 130 may comprise at least one optical rotary encoder configured for optically detecting the at least one second rotational movement of the transmission output shaft 126. The first angle sensor 128 may comprise at least one magnetic rotary encoder configured for generating absolute angle and direction information.

[0224] As can be seen in Figure IB, the first angle sensor 128 may be arranged at an input of the transmission mechanism 124 or, alternatively, directly at the actuator 118. The second angle sensor 130 may be arranged at an output of the transmission mechanism 124.P39273 -EP

[0225] - 32 -

[0226] Further, the transmission mechanism 124 may be at least partially made from at least one plastic material and / or from at least one metal material. As an example, the transmission mechanism 124 may be made from at least one thermoplastic material, such as from at least one polycarbonate, or polyoxymethylene or the like. The transmission mechanism 124 may have a rotational stiffness in the range of 1 to 1000 mNm / rad, specifically in the range of 10 to 500 mNm / rad, more specifically in the range of 50 to 300 mNm / rad, even more specifically is 200 mNm / rad, with respect to the transmission output shaft 126. Such a rotational stiffness of the transmission mechanism 124 may advantageously enhance a difference or deviation in the rotational movements between the actuator shaft 120 and the transmission output shaft 126 which can be used to determine a potential occlusion of the medication delivery device 110.

[0227] Figure 2 shows a flow chart of a method for determining occlusion dysfunctional operation of a medication delivery device 110. The medication delivery device 110 is a medication delivery device 110 according to the present invention, such as according to the exemplary embodiment shown in Figure 1A and / or according to any other embodiment disclosed herein. Thus, for a detailed description of the medication delivery device 110, reference is made to the description of Figure 1A. Specifically, the method may be performed on the medication delivery device 110.

[0228] The method comprises the following steps, which, as an example, may be performed in the given order. It shall be noted, however, that a different order is also possible. Further, it is possible to perform one or more or even all of the method steps once or repeatedly. Further, it is possible to perform two or more of the method steps simultaneously or in a timely overlapping fashion. The method may comprise additional method steps, which are not listed.

[0229] The method comprises the following steps:

[0230] a) (denoted by reference number 140) driving the actuator 118 to move the dispensing element via the transmission output shaft 126 of the transmission mechanism 124 to dispense medication, specifically liquid medication, out of a reservoir 114 of the medication delivery device 110;

[0231] b) (denoted by reference number 142) determining a first rotational movement of the actuator shaft 120 by using the first angle sensor 128;

[0232] c) (denoted by reference number 144) determining a second rotational movement of the transmission output shaft 126 by using the second angle sensor 130; andP39273 -EP

[0233] - 33 -

[0234] d) (denoted by reference number 146) determining, by using the controller 132, a dysfunctional deviation between the first rotational movement of the actuator shaft and the second rotational movement of the transmission output shaft.

[0235] The method may specifically comprise using the at least one medication delivery device 110, specifically without having the medication delivery device 110 applied to the user. Thus, in this example, the dispensing of the medication out of the reservoir 114 may not comprise a delivery of the medication to the user. Alternatively, the method may also be performed after application of the medication delivery device 110 to the user.

[0236] The determining of the dysfunctional deviation may comprise determining at least one first rotation angle cpmotof the actuator shaft 120 using the first rotational movement, and at least one second rotation angle cpoutof the transmission output shaft 126. Further, the method may comprise determining an effective torsional moment T at the transmission output shaft 126 according to:

[0237] T — b I (P111011I

[0238] * ^out I T*out b

[0239]

[0240] \Lg /

[0241] wherein koutdenotes a rotational stiffness of the transmission mechanism 124 and igdenotes a total transmission ratio of the transmission mechanism 124 with respect to the transmission output shaft 126. As outlined above, the dysfunctional deviation between the first rotational movement of the actuator shaft 120 and the second rotational movement of the transmission output shaft 126 may be determined in case the effective torsional moment exceeds at least one dysfunctional deviation threshold, specifically for a predetermined number of times and / or for a predetermined time interval.

[0242] Figure 3 shows a diagram of a simulation of the effective torsional moment T (denoted by reference number 148) at the transmission output shaft 126. Specifically, the diagram of Figure 3 shows the simulated effect torsional moment 148 in mNm as a function of time 150 in seconds s. The simulation was performed using above-identified formula with a rotational stiffness of 200 mNm / rad (given with respect to the output shaft) and a total transmission ratio of i=l 13.

[0243] As can be seen in the diagram, the effective torsional moment 148 may be overlapped by errors from the transmission mechanism 124, such as pulsing effects of due to stick-slip behavior of the sealing O-rings of the reservoir. Starting from a time of 105 seconds, the strong dips in the signal may indicate stepping errors of the actuator 118, for example due toP39273 -EP

[0244] - 34 -

[0245] loss of pretension in the transmission mechanism 124. The dysfunctional deviation between the first rotational movement of the actuator shaft 120 and the second rotational movement of the transmission output shaft 126, e.g. an occlusion at the medication delivery device 110, may be detected in case the effective torsional moment exceeds the occlusion threshold, e.g. at 4 mNm. The dysfunctional deviation may also be determined only in case the dysfunctional deviation threshold is exceeded for a predetermined number of times and / or for a predetermined time interval.P39273 -EP

[0246] - 35 -

[0247] List of reference numbers

[0248] 110 medication delivery device

[0249] 112 insulin pump

[0250] 114 reservoir

[0251] 116 plunger

[0252] 118 actuator

[0253] 120 actuator shaft

[0254] 122 electric motor

[0255] 124 transmission mechanism

[0256] 126 transmission output shaft

[0257] 128 first angle sensor

[0258] 130 second angle sensor

[0259] 132 controller

[0260] 134 actuator gear

[0261] 136 output gear

[0262] 138 intermediate gear

[0263] 140 driving the actuator

[0264] 142 determining a first rotational movement 144 determining a second rotational movement 146 determining an occlusion

[0265] 148 effective torsional moment

[0266] 150 time

Claims

P39273 -EP- 36 -Roche Diabetes Care GmbH March 26, 2025RD39273EP ST / KVClaims1. A medication delivery device (110) for delivering a medication to a user, the medication delivery device (110) comprising:- at least one actuator (118) configured for rotating at least one actuator shaft (120);- at least one transmission mechanism (124), wherein the transmission mechanism (124) comprises at least one transmission output shaft (126) that is configured to be coupled to a dispensing element, wherein the transmission mechanism (124) is configured for transmitting rotational movements of the actuator shaft (120) to the transmission output shaft (126) for advancing the dispensing element for dispensing liquid out of a reservoir (114) of the medication delivery device (no);- at least one first angle sensor (128) configured for determining at least one first rotational movement of the actuator shaft (120);- at least one second angle sensor (130) configured for determining at least one second rotational movement of the transmission output shaft (126); and - at least one controller (132) configured for determining a dysfunctional deviation between the first rotational movement of the actuator shaft (120) and the second rotational movement of the transmission output shaft (126).

2. The medication delivery device (110) according to the preceding claim, wherein the dysfunctional deviation between the first rotational movement of the actuator shaft (120) and the second rotational movement of the transmission output shaft (126) is indicative of at least one of an occlusion of the medication delivery device (110); a dysfunctional resistance of the medication delivery device (110); a dysfunctional forward resistance of the medication delivery device (110); a dysfunctional rotational resistance of the medication delivery device (110).

3. The medication delivery device (110) according to any one of the preceding claims, wherein the first angle sensor (128) comprises at least one angle sensor selected from the group consisting of a photointerrupter and an impeller wheel; a rotary encoderP39273 -EP- 37 -using interruptive, reflective or light intensity measuring optical principles; a magnetic rotary encoder; an inductive rotary encoder; a capacitive rotary encoder; a potentiometric rotary encoder; an optical rotary encoder, specifically an absolute optical rotary encoder and / or an incremental optical rotary encoder; a rotary encoder based on a control signal of the motor; a rotary encoder based on the back EMF of the motor; an internal motor sensor.

4. The medication delivery device (110) according to any one of the preceding claims, wherein the second angle sensor (130) comprises at least one angle sensor selected from the group consisting of a photointerrupter and an impeller wheel; a rotary encoder using interruptive, reflective or light intensity measuring optical principles; a magnetic rotary encoder; an inductive rotary encoder; a capacitive rotary encoder; a potentiometric rotary encoder; an optical rotary encoder, specifically an absolute optical rotary encoder and / or an incremental optical rotary encoder.

5. The medication delivery device (110) according to any one of the preceding claims, wherein the transmission mechanism (124) comprises at least one actuator gear (134) coupled to the actuator shaft (120) and at least output gear (136) coupled to the transmission output shaft (126), wherein the rotational movements of the actuator shaft (120) is transmitted to the transmission output shaft (126) via interaction of the actuator gear (134) with the output gear (136), wherein the second angle sensor (130) comprises at least one optical rotary encoder configured for optically detecting the at least one second rotational movement of the transmission output shaft (126) by tracking a surface movement of the output gear (136).

6. The medication delivery device (110) according to any one of the preceding claims, wherein the controller (132) is configured for determining at least one first rotation angle cpmotof the actuator shaft (120) using the first rotational movement, wherein the controller (132) is further configured for determining at least one second rotation angle cpoutof the transmission output shaft (126) using the second rotational movement, wherein the controller (132) is further configured for determining an effective torsional moment T at the transmission output shaft (126) according to:T — b I (P111011I* ^out I T*out b\Lg / P39273 -EP- 38 -wherein koutdenotes a rotational stiffness of the transmission mechanism (124) and igdenotes a total transmission ratio of the transmission mechanism (124) with respect to the transmission output shaft (126).

7. The medication delivery device (110) according to the preceding claim, wherein the controller (132) is configured for determining the dysfunctional deviation between the first rotational movement of the actuator shaft (120) and the second rotational movement of the transmission output shaft (126) in case the effective torsional moment exceeds at least one dysfunction deviation threshold.

8. The medication delivery device (110) according to any one of the preceding claims, wherein the controller (132) is configured for performing at least one priming test comprising determining at least one initial rotational movement of the actuator shaft (120) and at least one initial rotational movement of the transmission output shaft (126) with an open medication delivery device (110).

9. The medication delivery device (110) according to the preceding claim, wherein the priming test comprises determining at least one of a calibration of the first rotational movement of the actuator shaft (120) and the second rotational movement of the transmission output shaft (126); a friction of the transmission mechanism (124); an error of the transmission mechanism (124); a determination of system parameter and a comparison to old values or against a predefined threshold or against values determined in the production line and saved in the medication delivery device (110); a plausibility check for at least one of the first angle sensor (128) and the second angle sensor (130) comprising checking if signals are readable and make sense, etc.; a plausibility check for the actuator (118).

10. The medication delivery device (110) according to any one of the preceding claims, wherein the transmission mechanism (124) has a rotational stiffness in the range of 1 to 1000 mNm / rad, specifically in the range of 10 to 500 mNm / rad, more specifically in the range of 50 to 300 mNm / rad, even more specifically is 200 mNm / rad, with respect to the transmission output shaft (126).

11. The medication delivery device (110) according to any one of the preceding claims, wherein the medication delivery device (110) further comprises at least one reservoir (114) configured for storing the medication, wherein the dispensing element comprisesP39273 -EP- 39 -at least one plunger (116) that is movably arranged within the reservoir (114), wherein the plunger (116) is configured for dispensing the medication out of the reservoir (114), and wherein the plunger is coupled to the at least one transmission output shaft of the transmission mechanism.

12. The medication delivery device (110) according to any one of the preceding claims, wherein the medication delivery device (110) is an insulin pump (112).

13. A method for determining a dysfunctional operation of a medication delivery device (110) according to any one of the preceding claims, wherein the method comprises the following steps:a) driving the actuator (118) to move the dispensing element via the transmission output shaft (126) of the transmission mechanism (124) to dispense medication out of a reservoir (114) of the medication delivery device (110);b) determining a first rotational movement of the actuator shaft (120) by using the first angle sensor (128);c) determining a second rotational movement of the transmission output shaft (126) by using the second angle sensor (130); andd) determining, by using the controller (132), a dysfunctional deviation between the first rotational movement of the actuator shaft (120) and the second rotational movement of the transmission output shaft (126).

14. A computer program comprising instructions which, when the program is executed by the medication delivery device (110) according to any one of the preceding claims referring to a medication delivery device (110), cause the medication delivery device (110) to perform the method according to any one of the preceding claims referring to a method.

15. A computer-readable storage medium comprising instructions which, when the instructions are executed by the medication delivery device (110) according to any one of the preceding claims referring to a medication delivery device (110), cause the medication delivery device (110) to perform the method according to any one of the preceding claims referring to a method.

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