Drug delivery device, system including drug delivery device, and related methods

Abstract

A drug delivery device (100) is provided, comprising: a thermal coupling surface (130) arranged and configured to transfer thermal energy; and a thermal control component (150) thermally conductively connected to the thermal coupling surface, wherein the thermal control component is configured to operate in response to thermal energy transferred through the thermal coupling surface, and wherein the drug delivery device is configured to perform a drug delivery operation.

Description

Background Art

[0001] The present disclosure relates to a drug delivery device, a system having a drug delivery device, and a method involving a drug delivery device, for example, a method for evaluating a drug delivery device, particularly the operation of a drug delivery device.

[0002] Drug delivery devices are typically used by a user, such as a patient and / or a caregiver or other medically trained or non-medically trained personnel, to administer a drug from a drug container into a body, such as a human body.

[0003] It is an object of the present disclosure to provide improvements relating to drug delivery devices and / or their operation.

[0004] This object is achieved by the subject matter according to the independent claims. Advantageous embodiments and improvements may be subject to the dependent claims or be included elsewhere in the present disclosure. Furthermore, the present disclosure may contain subject matter relating to improvements in drug delivery devices, but which are not claimed dependently or independently. Summary of the invention

[0005] According to one aspect, the present disclosure relates to a drug delivery device. The drug delivery device can be configured to perform a drug delivery operation, particularly when actuated or started by a user. According to another aspect, the present disclosure relates to a system comprising a drug delivery device. According to yet another aspect, the present disclosure relates to a method. The method can be a method for evaluating or influencing the operation of a drug delivery device, particularly a drug delivery device, such as a delivery operation. The device evaluated in the method is preferably a disclosed drug delivery device.

[0006] It should be understood that features disclosed with respect to different aspects or embodiments are also applicable to other aspects or embodiments. For example, features disclosed for drug delivery devices are also applicable to the systems and methods, and vice versa. Moreover, features disclosed in conjunction with different embodiments can be combined with each other.

[0007] In an embodiment, the drug delivery device includes a thermal coupling surface. The thermal coupling surface can be arranged and / or configured to transfer (e.g., receive and / or emit) thermal energy, e.g., heat. The thermal coupling surface can be configured to be thermally coupled to another element. The thermal coupling surface can be formed by a thermally conductive material (e.g., metal or metal alloy). The area surrounding or adjacent to the thermal coupling surface laterally can be formed by a material with a lower thermal conductivity. Typically, plastics have a lower thermal conductivity than metals. For energy transfer, the thermal coupling surface can be introduced into a thermally conductive connection (e.g., mechanical contact) with the surface of another element to which energy transfer should be performed, the surface being, for example, the skin of a subject that should receive the drug to be delivered by the device to be used. The drug delivery device can be configured so that after thermal energy (e.g., heat) has been received by the thermal coupling surface, it is guided away from the thermal coupling surface.

[0008] In an embodiment, the drug delivery device includes a thermally controlled or thermally operated component. The thermal control component can change its state in response to the thermal energy provided to it. The thermal control component can be thermally connected to a thermal coupling surface. The thermal control component can be configured to operate in response to the thermal energy transferred through the thermal coupling surface. Therefore, thermal energy can be used in the drug delivery device to monitor the operation of the device, evaluate the operation of the device, control the operation of the device, and / or affect the operation of the device. The operation can be a drug delivery operation.

[0009] In an embodiment, the thermal control member is a thermal energy conversion member. The thermal energy conversion member can be arranged and / or configured to convert thermal energy (particularly thermal energy transferred to the thermal energy conversion member, for example, via a thermal coupling surface) into non-thermal energy. In the device, the converted non-thermal energy can be used to evaluate, monitor and / or affect the operation of the drug delivery device.

[0010] In an embodiment, thermal energy is supplied to the thermal control member through the thermal coupling surface.Thus, the thermal coupling surface can act as an energy input surface.

[0011] In embodiments, the non-thermal energy is electrical energy or mechanical energy (eg, kinetic energy).

[0012] In an embodiment, the non-thermal energy is kinetic energy or potential energy convertible into kinetic energy, which is used to move one portion of the drug delivery device (e.g., the thermal energy conversion member or a region thereof) relative to another portion of the drug delivery device, particularly in response to thermal energy supplied to the thermal energy conversion member.

[0013] In an embodiment, the thermal control member is a movable member that can move in response to thermal energy provided to the thermal control member and / or leaving the member.Thus, thermal energy can be used to affect the operation of the drug delivery device.

[0014] In an embodiment, the thermal control component is an electrical component or an electronic component. The thermal control component can be operatively connected to a power source of the device and / or other electrical or electronic components or elements of the device. The thermal energy provided to the component can cause a change in the electrical characteristics of the component and / or the generation of an electrical signal in response to the thermal energy.

[0015] In an embodiment, the thermal control member is an electrical temperature sensor, preferably an electronic temperature sensor, or an electrical temperature triggerable switch, preferably an electronic temperature triggerable switch. Therefore, the thermal control member can operate in response to the temperature at the thermal coupling surface. Therefore, the operation of the drug delivery device can be controlled by the temperature at the thermal coupling surface. When there is a predetermined temperature at the thermal coupling surface, the switch can activate an electric drive mechanism or an electronic control unit when triggered, for example. The temperature sensor can allow information about the current temperature at the thermal coupling surface to be retrieved (for example, electronically). For example, the temperature sensor can be an active sensor or a passive sensor, the active sensor generates an electrical signal indicating the temperature at the thermal coupling surface, the passive sensor depends on the temperature at the thermal coupling surface to change the electrical characteristics, for example, a sensor that changes its resistance depending on the temperature at the coupling surface, such as a thermistor, for example, a PTC component or an NTC component.

[0016] In an embodiment, the thermal control member (eg, thermal energy conversion member) is configured to generate an electrical signal in response to thermal energy and / or changes in thermal energy. The thermal energy may be thermal energy supplied to the thermal control member via a thermal coupling surface.

[0017] In an embodiment, the electrical signal indicates the temperature of an element that is or is to be thermally conductively connected to (e.g., mechanically contacted with) the thermal coupling surface. Thus, the device can be configured to operate depending on the temperature at the coupling surface, and / or the temperature at the thermal coupling surface can be recorded, monitored, and / or stored in the drug delivery device or in an external component or system, such as a computer system.

[0018] In an embodiment, a thermal control member (e.g., a region thereof or an entire member) is arranged and / or configured to move in response to the thermal energy transmitted by the thermal coupling surface. The thermal control member can convert thermal energy into kinetic energy. The movement can be used for the operation of the drug delivery device, for example, to trigger an electric switch and / or release a mechanical lock. The corresponding event (i.e., the release of the mechanical lock and / or the triggering of the switch) can cause the device to operate, for example, the delivery operation can be started only after the event. For example, releasing the mechanical lock can cause two parts or elements of the device to move relative to each other in a direction that is impossible to move when the mechanical lock is established.

[0019] In an embodiment, the thermal control component is a bimetallic component. In a bimetallic component, two metal elements of different metals can be used, which are thermally conductively connected to each other and have different thermal expansion coefficients. Once thermal energy is supplied to the bimetallic component (e.g., to increase the temperature of the component), the two metal elements will expand differently, which may cause movement of at least a portion of the bimetallic component.

[0020] In an embodiment, the thermal control component is designed to operate at a temperature greater than or equal to one of the following values: 22°C, 23°C, 24°C, 25°C, 26°C, 27°C, 28°C, 29°C, 30°C, 31°C, 32°C, 33°C, 34°C.

[0021] In embodiments, the operating temperature is suitably greater than or equal to ambient temperature.

[0022] In an embodiment, the thermal control component is designed to operate at a temperature less than or equal to one of the following values: 44°C, 43°C, 42°C, 41°C, 40°C, 39°C, 38°C, 37°C, 36°C, 35°C, 34°C, 33°C, 32°C, 31°C, 30°C, 29°C.

[0023] A temperature range (eg, an operating temperature range) can be formed by combining the upper and lower boundaries of a range of any values ​​selected from the above list (eg, 28 to 36° C.) These values ​​can be selected from different lists or from the same list.

[0024] It may be advantageous to make the operating temperature range as narrow as possible, for example the difference between the lower limit and the upper limit of the temperature range is at most 10°C, 8°C or 5°C, in which case, by appropriately selecting the temperature range, if an element having a temperature within said range contacts the thermal coupling surface, it is highly likely that the skin of a user contacts the thermal coupling surface. Furthermore, narrowly selecting the operating temperature range reduces the risk that the device operates in an erroneous manner by contacting an erroneous component that accidentally has a temperature in the desired operating temperature range.

[0025] In an embodiment, the thermal control member is designed to operate at a normal skin temperature or normal body temperature of a mammal (preferably a human). The operating temperature range suitably covers a normal skin temperature of a human and / or a normal body temperature of a human. At normal ambient temperatures, a normal skin temperature of a human may be between 32°C and 34°C. For example, at an ambient temperature of 15°C, the skin temperature may be as low as 24°C. At higher ambient temperatures, the skin temperature may reach 36°C. In contrast to skin temperature, body temperature is typically higher, such as between 35°C and 43°C, for example, about 37°C.

[0026] It may be advantageous that the drug in the medication container has a temperature close to body temperature. This is more comfortable for the user than delivering a drug that is too hot or too cold. In an embodiment, skin temperature may be used as an indication of whether drug delivery will be performed into the correct structure.

[0027] In an embodiment, the drug delivery device comprises a housing. The housing may house additional (eg, internal) components of the drug delivery device, such as one or more members of a drive mechanism operable to dispense drug from the delivery device in a drug delivery operation.

[0028] In an embodiment, the drug delivery device includes a receiving portion. The receiving portion can be disposed in the housing or, for example, permanently or releasably connected to the housing. The receiving portion can be designed to receive a medication container, such as a cartridge or a syringe. In the drug delivery device, the medication container can be received in the receiving portion, or the receiving portion can be container-free and configured to be equipped with a container.

[0029] In an embodiment, the drug delivery device includes a drive mechanism. The drive mechanism can be operated to drive a drug delivery operation. The drive mechanism can include at least one movable drive member. The movable drive member can be movable relative to the housing so as to deliver the medicament from the container through the dispensing opening of the drug delivery device during the drug delivery operation. The movable drive member can be movable relative to the housing and / or relative to the medicament container. The movable drive member can be, for example, a plunger. The movable drive member can be biased, such as by a spring, to drive the dispensing operation when the bias is released.

[0030] In an embodiment, the thermal coupling surface is an outer surface of a drug delivery device or an inner surface of a drug delivery device. During and / or before the drug delivery operation occurs, the outer surface of the device is accessible from the outside. The outer surface can be touched by a user. However, the inner surface can be hidden during the drug delivery operation and is not configured to be touched by a user. On the contrary, mechanical contact connection with the inner surface can be prevented, for example, by a housing.

[0031] In an embodiment, the thermal coupling surface is associated with a receiving portion of a drug delivery device. When a drug container is arranged in a receiving portion, the thermal coupling surface can be thermally connected to the drug container. Therefore, via the thermal coupling surface, information about the temperature of the drug container can be collected, and therefore information about the temperature of the drug contained in the container can be collected. For example, if the temperature of the drug medicament and the container is too low or too high, the operation of the drug delivery device can be prevented such as electronically (for example, because an electronic control unit does not issue necessary commands) or mechanically (for example, by a mechanical lock that is not released due to insufficient thermal energy).

[0032] In an embodiment, the drug delivery device is configured so that, in response to the thermal energy supplied to the thermal coupling surface, a mechanical lock, for example, inside the drug delivery device is released. Here, "in response to the thermal energy supplied to the thermal coupling surface" can cover the conversion of thermal energy to kinetic energy or electrical energy and the change of the electrical characteristics of the electric thermal control component. The mechanical lock can prevent the movement of the elements of the device, preferably the elements that need to be moved in order to start the drug delivery operation when established. The mechanical lock can allow the element to move in the direction previously blocked when released. Therefore, when the mechanical lock is released, the delivery operation can be triggered. The element can be a movable member, which can preferably be moved relative to the housing of the drug delivery device to start the drug delivery operation and / or before starting the drug delivery operation. The element can be a trigger member arranged to start the delivery operation. The trigger member can be a trigger button, such as a button at the proximal end of the drug delivery device or a needle shield at the distal end of the drug delivery device, for example. For example, the thermal coupling surface can be arranged on the movable member or on the housing.

[0033] In an embodiment, the drug delivery device includes an activation surface. The activation surface can be arranged to be contacted by a user to start the drug delivery operation of the drug delivery device. The activation surface can be the surface of a trigger member, for example, a distal surface (i.e., a surface facing the distal direction) or a proximal surface (i.e., a surface facing the proximal direction). The thermal coupling surface can be accessible on the activation surface, for example, arranged on the activation surface. Therefore, the thermal energy supplied via the thermal coupling surface can be supplied by an element (preferably skin) mechanically contacted by the activated surface. If thermal energy is supplied to the thermal coupling surface on the activation surface, this energy can be used, for example, to determine whether the element contacting the thermal coupling surface has or has had a desired temperature.

[0034] In an embodiment, the drug delivery device includes a support surface. The support surface can be arranged to contact the skin of a user or patient, preferably during and / or before the drug delivery operation, for example, when the delivery operation is started or only after the delivery operation has been started. The thermal coupling surface can be accessible on the support surface, for example, it is arranged on the support surface. Therefore, the heat energy supplied via the thermal coupling surface can be supplied by the element (preferably skin) mechanically contacted by the support surface. If heat energy is supplied to the thermal coupling surface on the support surface, this energy can be used to determine whether the element contacting the thermal coupling surface has or has had a desired temperature. The support surface can be adjacent to the target area for the drug delivery operation on the skin, for example, the medicament from the medicament container should be delivered (for example, injected) to the area therein. Therefore, heat energy can be supplied to the thermal coupling surface near the target area. If the thermal control member is adjusted to the temperature of the target area (which can generally be the temperature of the target area), the heat energy is supplied near the target area. In this way, the particularly reliable operation of the thermal control member can be achieved. The support surface can be different from the activation surface. The support surface can be the same surface as the activation surface. The bearing surface may be provided at the distal end of the drug delivery device and / or it may be a distal surface.

[0035] In an embodiment, the thermal coupling surface may be disposed on the activation surface and the thermal coupling surface may be disposed on the support surface.

[0036] In an embodiment, the activation surface is movable relative to the support surface. The thermal coupling surface on the support surface can be arranged and configured to contact the skin only after the activation surface has moved from a first or initial position to a second or end position. In the end position, the drug delivery operation is preferably already initiated. Therefore, when the thermal coupling surface on the support surface is contacted by the skin, it can be ensured that the drug delivery operation has been initiated. Before the support surface is contacted by the skin, the same area of ​​the skin or an adjacent area of ​​the skin can contact the activation surface and move the activation surface toward the support surface.

[0037] In an embodiment, the drug delivery device includes an electronic control unit, such as a microcontroller or microprocessor. The thermal control member can be operatively coupled or coupleable to the electronic control unit. Thus, the thermal control member can communicate with the electronic control unit. Thus, the electronic control unit can operate based on information, signals or data supplied to it from the thermal control member. For example, a data signal indicating the temperature at the thermal coupling surface can be transmitted from the thermal control member to the electronic control unit.

[0038] In an embodiment, the operation of the drive mechanism is controlled by an electronic control unit. For example, the electronic control unit can issue commands to a drive control member, which in response to the command moves a movable member (eg, motor-driven) to drive a drug delivery operation.

[0039] In an embodiment, the drug delivery device is configured such that the electronic control unit permits initiation of a drug delivery operation only if the temperature at the thermal coupling surface is within a predetermined temperature range. For example, the control unit may activate the drive mechanism only if the temperature is within a predetermined temperature range and / or release the mechanical lock only if the temperature is within a predetermined temperature range. The predetermined temperature range may be selected to characterize a human skin temperature or body temperature.

[0040] In an embodiment, the drug delivery device is configured to store and / or transmit data about the temperature at the thermal coupling surface, particularly when the delivery operation has been started and / or when the delivery operation is being performed. Storage and / or data transmission can be controlled by an electronic control unit. Data transmission can occur from the drug delivery device to an evaluation unit, which can be configured to evaluate temperature data. In this way, it is possible to evaluate whether the temperature at the thermal coupling surface is within a predetermined temperature range, for example, externally at startup and / or during the execution of the drug delivery operation. Therefore, if the temperature is within the characteristic range of human skin temperature (e.g., 24°C to 36°C), and the thermal coupling surface is arranged to contact the skin, it can be assumed that the drug delivery device has been used to inject the drug into the human body. If the thermal coupling surface is thermally connected to the medicament container, it can be judged whether the temperature of the drug is or was within a suitable temperature range.

[0041] In an embodiment, the system includes a drug delivery device and an evaluation unit. The evaluation unit can be integrated into the drug delivery device, or separated from the drug delivery device but operatively coupled or can be coupled to the drug delivery device (e.g., using a wired or wireless connection). The drug delivery device can be configured to pass the temperature data indicating the temperature at the thermal coupling surface during the delivery operation and / or when the delivery operation is started to the evaluation unit. The evaluation unit can be configured to evaluate the temperature data, for example, by comparing it with a predetermined temperature or a predetermined temperature range. Depending on the result of the evaluation, the evaluation unit can generate different outputs, for example, meet or do not meet the predetermined temperature range. Therefore, users, patients or caregivers can take appropriate measures depending on the result (e.g., output) of the evaluation.

[0042] In an embodiment, the method includes a step of comparing the temperature at the thermal coupling surface to a predetermined temperature or a predetermined temperature range, for example, before, during and / or after the delivery operation. The temperature can be derived from a thermal control member. The temperature can be the current temperature at the thermal coupling surface. If the temperature is within a predetermined temperature range, the delivery operation can be allowed to be started. If not, startup can be prevented. Alternatively or additionally, if the temperature is within the range, a corresponding output indicating that the temperature is correct can be transmitted to another device, such as a computer system. Alternatively or additionally, if the temperature is not within the range, a corresponding output indicating that the temperature is incorrect can be transmitted to another device. Depending on the result of the evaluation, appropriate measures can be taken.

[0043] In a particularly advantageous embodiment, there is provided a drug delivery device comprising:

[0044] - a thermal coupling surface arranged and configured to transfer thermal energy,

[0045] - a thermal control member thermally conductively connected to the thermal coupling surface, wherein the thermal control member is configured to operate in response to thermal energy transferred through the thermal coupling surface, and wherein the drug delivery device is configured to perform a drug delivery operation.

[0046] Further features, advantages, and conveniences of the present disclosure will become apparent from the following description of exemplary embodiments taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] 1A and 1B show different schematic diagrams of embodiments of a drug delivery device.

[0048] 2A and 2B illustrate an embodiment of a drug delivery device in two different situations.

[0049] FIG. 3 illustrates another embodiment of a drug delivery device based on a schematic cross-sectional view.

[0050] FIG. 4 shows schematic electronic components of an embodiment of a drug delivery device. DETAILED DESCRIPTION

[0051] In the accompanying drawings, the same elements, elements with the same function and elements of the same kind may be designated using the same reference numerals. It should be noted that the features disclosed further above and / or further below may be combined with each other and / or be considered to be disclosed independently of each other, i.e., without an indispensable connection with other features disclosed in the same context.

[0052] Figures 1A and 1B show different schematic views of an embodiment of a drug delivery device 100. Figure 1A shows a schematic side view of the drug delivery device 100, and Figure 1B shows a top view on the distal end of the drug delivery device.

[0053] The drug delivery device 100 includes a housing 110. Within the housing 110, a drive mechanism may be held. The drug delivery device may be operable to drive a dispensing or delivery operation to dispense a drug (such as a liquid drug) from a drug container received or receivable in the drug delivery device and particularly in the housing 110. The housing 110 may be designed to receive a drug container internally. A container receiving portion may be provided within the housing 110, which may receive and / or hold a container (not explicitly shown). The container receiving portion may secure the drug container to prevent movement relative to the housing, or may move relative to the housing together with the container. The container may be a cartridge or a syringe. The amount of drug that the container may hold is sufficient for the device to deliver multiple doses in separate delivery operations or to deliver only a single drug dose in one delivery operation. The drug delivery device may include a dose setting mechanism, i.e., a mechanism that permits, for example, selection of a dose size to be dispensed from a variety of possible sizes. The dose setting mechanism may include at least one dose setting member movably connected to the housing and operable to move relative to the housing to set a dose of a drug (not explicitly shown, see drug 170 in FIG. 3 ). The drive mechanism may include a plunger (not explicitly shown, see plunger 190 in FIG. 3 ). For a delivery operation, the plunger may be driven in a distal direction relative to the housing 110.

[0054] In the context of the present disclosure, "distal" or "distal direction" may mean a preferred axial direction towards the dispensing end of the device and / or away from an end of the device that is away from the dispensing end (e.g. opposite to the dispensing end). "Distal end" may mean an end of an element of the device that is arranged or to be arranged to face towards or closest to the dispensing end of the device, or away from or away from an end of the device that is away from the dispensing end (e.g. opposite to the dispensing end).

[0055] In the context of the present disclosure, "proximal" or "proximal direction" may mean a preferred axial direction away from the dispensing end of the device and / or towards an end of the device that is away from the dispensing end (e.g., opposite to the dispensing end). "Proximal end" may mean an end of an element of a device that is arranged or to be arranged away from or farthest from the dispensing end of the device, or toward an end of the device that is away from the dispensing end (e.g., opposite to the dispensing end). In FIG. 1A , the proximal end of the device is designated by "P" and the distal end is designated by "D", wherein the dispensing end of the device is to the left of the distal end.

[0056] The distal movement of the plunger can cause the drug to be delivered from the container via the outlet of the device, for example, one end of the needle facing the distal direction or another opening. During the delivery operation, the plunger can be driven by the energy provided to the plunger by means of an energy storage member, wherein the energy is released during the delivery operation. The energy storage member can be, for example, a drive spring (not explicitly shown). However, pressurized gas can also be used to provide energy for the delivery operation. The energy stored in the energy storage member can be pre-stored in the device. That is, the user does not need to provide the energy for the delivery operation, but the energy stored in the energy storage member during the manufacturing process. In other words, the drug delivery device 100 depicted can be an automatic injector.

[0057] The movable member 120 is movably coupled to the housing 110. The movable member 120 can be retained in the housing 110 so that it cannot be removed. As depicted in FIG. 1A, a portion of the movable member 120 can protrude from the distal end of the housing 110 at least in the initial or first position. For example, the movable member 120 can be moved from the first position to the second position relative to the housing in the proximal direction, for example, in order to trigger the delivery operation of the drive mechanism retained in the housing 110 and / or for the needle insertion step, which inserts the needle into the user's skin. For example, the movable member 120 can be further moved into the housing in order to trigger the delivery operation, that is, it can act as a trigger member. Alternatively or additionally, the movable member 120 can be a needle cover or needle shield movably coupled to the housing to prevent accidental contact between the user and the needle in the interior of the device and / or shield the needle from contact by the user, so that before, during and / or after the completion of the drug delivery operation, the needle is invisible to the user. The movable member 120 can cover the needle in the initial position depicted in FIG. 1A. If the movable member 120 is not used to trigger the delivery operation, a separate trigger member (such as a trigger button), for example, at the proximal end of the housing can be used for this purpose (not shown). The needle can be retained in the housing. For example, the needle can preferably be permanently attached to the medication container, in which case the medication container can be, for example, a syringe with a stake needle. Alternatively, the needle can be a needle separate from the medication container. In this case, the medication container can be, for example, a cartridge. It should be noted that the disclosed concepts are not only applied to automatic injectors. Instead, the disclosed concepts are also applied to other drug delivery devices, such as drug delivery devices for delivering user-settable doses or fixed doses with or without force assistance during dose delivery. These concepts can be applied to pen-type devices, such as pen-type injectors. The device can be needle-based or needle-free. The device can be a personal item, for example, sized and shaped to be stored in a bag. The device can be suitable for use by medically untrained personnel and / or for self-administration of drugs. The device can be designed for subcutaneous injection procedures. It should also be noted that the present disclosure is not limited to drug delivery devices having a movable member 120 at the distal end. Rather, other types of devices, for example having a rigid distal end, may also be used in the present context.

[0058] The distal end of the drug delivery device 100 may be provided with a removable cap that can be removed before the delivery operation is performed. In the case depicted in Figures 1A and 1B, the cap (if present) has been removed, if applicable, together with a soft or rigid needle shield that covers the needle distally. In Figure 1B, it can be seen that the distal end of the needle 140 has a delivery opening through which the drug can leave the drug delivery device. The member 120 and / or the housing 110 can surround the needle 140 when viewed in a top view and / or also axially. Therefore, laterally, the needle can be shielded by means of a movable member 120 that acts as a needle shield or needle cover.

[0059] FIG. 1B shows that one or more thermal coupling surfaces or surface areas 130 can be accessible on the distal side of the drug delivery device. The corresponding surface can be a distal surface. That is, the corresponding thermal coupling surface can be arranged to thermally contact and / or mechanically contact the body skin to which the drug delivery device should deliver the drug during the delivery operation. In the depicted arrangement, a plurality of coupling surfaces 130 are provided on each of the distal ends of the housing 110 and the movable member 120. However, it should be noted that both the housing and the movable member do not need to include thermal coupling surfaces. For example, it is sufficient to touch at least one thermal coupling surface at the distal end that can be located on any of these members. Moreover, if a movable member is not provided at the distal end of the device or even if a movable member is provided at the distal end, a thermal coupling surface can only be provided on the distal surface of the housing 110. The corresponding thermal coupling surface 130 can be provided by a thermally conductive material (e.g., a metal or a metal alloy). The area arranged around the thermal coupling surface 130 or laterally adjacent to the thermal coupling surface, for example when viewed in a top view, can have a material with a lower thermal conductivity than the thermal coupling surface, for example, plastic. The corresponding thermal coupling surface 130 can be a recessed area, a protruding area, or an area flush with an adjacent area. In the depicted configuration, the thermal coupling surface 130 is circumferentially arranged on the element (here the housing 110 or the movable member 120) on which the thermal coupling surface is arranged. The thermal coupling surfaces 130 on different elements can be angularly offset from each other.

[0060] The corresponding thermal coupling surface 130 can be arranged and configured to receive thermal energy from the element on which the corresponding coupling surface is supported (e.g., the skin of the user) when the device is in operation. Therefore, the corresponding surface can be accessible on the supporting surface of the device (e.g., the distal surface of the movable member 120 and / or the housing 110). If one or more thermal coupling surfaces are provided on the distal surface of the device, the corresponding surface can be used to receive thermal energy from the user near the area where the delivery operation into the user is achieved (such as near the dispensing opening or needle, for example, laterally adjacent to the needle).

[0061] If at least one thermal coupling surface 130 is provided on each of two members (in the depicted embodiment, the housing 110 and the movable member 120) that are movable relative to each other, the thermally conductive connection between the thermal coupling surfaces on the two members and the target surface (e.g., skin) can occur during different stages of device operation, for example, during the start-up or triggering of the drug delivery operation and after the delivery operation has been initiated. For example, initially, the movable member 120 and the thermal coupling surface 130 on this member can be thermally contacted and / or mechanically contacted by the skin, and after the movable member has moved relative to the housing, the thermal coupling surface 130 on the housing 110 can be thermally contacted and / or mechanically contacted by the skin. This arrangement helps to distinguish between different operating stages via thermal energy provided to the corresponding thermal coupling surface 130 from the outside. However, it is also possible to have a thermal coupling surface 130 only on the movable member 120 or only on the housing 110. If the thermal coupling surface 130 is provided on the movable member, the initial skin contact can be used to transfer thermal energy to the thermal control member, for example to release a mechanical lock, as will be discussed further below. If a thermal coupling surface is provided on the housing 110, thermal energy may be transferred from the skin to the coupling surface when the housing has assumed its final position relative to the skin, for example, after a delivery operation has been initiated by the movable member, such as when the second position has been reached. Thus, in this case, the thermal energy may be used to provide an indication that a delivery operation has been triggered and / or information about the temperature of the surface to which the medicament or drug has been delivered, as will be discussed further below. The distal surface 116 of the housing 110 may be a support surface that contacts the skin before, during and / or after completion of a drug delivery operation. The distal surface 124 of the movable member may then be an activation surface (if the movable member is used to initiate a dose delivery operation) and / or a support surface.

[0062] The thermal energy supplied to the respective thermal coupling surfaces may be transferred to the thermal control member. The thermal control member may be a thermal energy conversion member. The thermal energy transferred to the thermal energy conversion member may be converted by the thermal energy conversion member into non-thermal energy, such as into mechanical potential energy and / or kinetic energy in order to move the elements of the device relative to each other, and / or into electrical energy to generate an electrical signal, which may be used to control the operation of the device by an electronic control unit, which is described in more detail later. As an alternative or in addition to energy conversion, the thermal energy supplied to the thermal control member may change a characteristic of the thermal control member, for example, an electrical characteristic. The change in characteristic may be used to influence and / or evaluate the operation of the device.

[0063] The respective thermal coupling surface 130 may be thermally conductively connected to the thermal control member. When a plurality of thermal coupling surfaces are provided, the thermal control member may be coupled to two different thermal coupling surfaces, or two different thermal coupling surfaces may be thermally separated from each other and thermally conductively connected to two different thermal control members. If the thermal coupling surfaces are provided in two different members that are movable relative to each other, it is appropriate that these coupling surfaces are thermally conductively connected to different thermal control members. In other words, the device may include one or more thermal control members.

[0064] Examples of thermal control components include bimetallic components (e.g., bimetallic strips) configured to convert thermal energy into mechanical energy (e.g., kinetic energy). The thermal control component may be a temperature sensor (e.g., an active or passive sensor) or a temperature-controlled switch. An active temperature sensor as a thermal control component may be configured to convert thermal energy into electrical energy (such as an electrical sensor signal), which may be transmitted to an electronic control unit that may be provided to control the operation of a drive mechanism, such as an electrical and / or motor drive, of a drug delivery device. An active temperature sensor may generate an electrical signal indicating a temperature. Such an active sensor may be a semiconductor-based sensor, for example, including a circuit system. A passive electrical temperature sensor may change an electrical characteristic, such as resistance or resistivity, depending on temperature. Examples of passive temperature sensors having temperature-dependent resistance include PTC thermistors or NTC thermistors (PTC: positive temperature coefficient; NTC: negative temperature coefficient). The temperature sensed by the corresponding sensor may be determined by or equal to the temperature at the thermal coupling surface. Instead of a sensor providing information about a specific temperature, a temperature-triggered switch may be used, which is triggered when the temperature is above or below a predetermined threshold.

[0065] Figures 2A and 2B illustrate an embodiment of a drug delivery device. For example, the device may be as further discussed above in conjunction with Figures 1A and 1B. Only the upper half as indicated by the dashed line is shown.

[0066] FIG2A illustrates a cross-sectional view of a portion of the distal region of the drug delivery device of FIG1A and FIG1B . Specifically, a movable member 120 and a housing 110 are depicted. Moreover, a thermal control member 150 is depicted, which is thermally connected to a thermal coupling surface 130 disposed at the distal end of the device 100. In the depicted embodiment, the thermal coupling surface 130 is a surface of the thermal control member 150 accessible on the distal end. However, it should be readily understood that, in particular when a sensor is used as a thermal control member but not limited to the described configuration, the thermal coupling surface 130 can also be a surface that is separate from the thermal control member but is only thermally connected to the member. The thermal control member 150 extends from the distal surface of the movable member 120 along the inner surface of the movable member 120, preferably in the axial direction, into the interior of the movable member, for example, a sleeve-shaped movable member.

[0067] In the depicted embodiment, the thermal control member 150 is a bimetallic member or a bimetallic strip. The thermal control member 150 includes a first metal or metal alloy layer 152 connected to a second metal or metal alloy layer 154. The materials of the layers 152 and 154 have different thermal expansion coefficients and / or the layers 152 and 154 are thermally conductively connected, for example, via welding, a press fit connection, or a form fit connection. Therefore, when thermal energy is supplied to one layer, this energy is also transferred to the second layer, especially when considering the high thermal conductivity of metals.

[0068] When thermal energy is supplied to the thermal coupling surface and the temperature of the member 150 increases, the different expansion coefficients result in different expansion behaviors of the layers 152 and 154, which causes movement of at least a portion of the thermal control member. The thermal control member 150 may include a fixed portion 158, which is preferably axially and rotationally fixed to, for example, another element (e.g., the movable member 120); and a movable portion 159, which is movable relative to the fixed portion, for example, pivotable relative to the fixed portion. The fixed portion may secure the thermal control member to the movable member. For example, the heat-induced movement of the thermal control member may be used to unlock a mechanical lock that prevents movement of the movable member 120, for example, in the proximal direction, such as movement required to trigger a drive mechanism and / or to penetrate a needle into the skin. In the depicted embodiment, the mechanical lock is provided by a locking portion 156 of the thermal control member 150, which is arranged to engage a mechanical stop 112 provided on the housing 110 in the situation depicted in FIG. 1A. The locking portion 156 can be offset proximally from the thermal coupling surface 130 and / or from the fixed portion 158. The locking portion can be located at the end region of the movable portion 159. It should be noted that the mechanical locking can also be achieved in different ways, such as by a movable element that moves under the control of an electronic control unit, wherein the movement depends on the temperature at the thermal coupling surface. Moreover, the movement of the thermal control element (e.g., a bimetallic strip) can be used to trigger an electrical switch that causes the electronic control unit to remove the mechanical locking. However, if the thermal control member 150 is used to establish the lock, the mechanism is particularly easy to implement and cost-effective. In the depicted embodiment, the mechanical stop 112 in the housing is provided by a recess. However, protrusions can also be used. In addition, the mechanical stop does not need to be implemented in the housing, but only needs to prevent, for example, proximal movement relative to the housing, so as to prevent the movable member 120 from moving from a first position to a second position required for the operation of the device 100. The thermal control member 150 (particularly its locking portion) can protrude from the inside of the movable member 120 toward the outside of the movable member through an opening 122 (e.g., a radial opening) in the movable member. On the outside of the movable member 120 (eg, on the inner surface of the housing 110 ), a mechanical stop 112 may be disposed and engaged by a portion 156 of the thermal control member 150 when mechanical locking is established.

[0069] By appropriately selecting the metal or metal alloy used for the bimetallic member, it can be ensured that when skin having a specific temperature (such as human skin temperature) (e.g., skin having a temperature of about 32 to 34° C. or other temperatures that human skin may have) mechanically contacts the thermal coupling surface 130, release of the mechanical lock occurs and the metal or metal alloy is heated from ambient temperature to skin temperature. One of the layers 152 and 154 (e.g., layer 152) can be made of or can contain MnNiCu, and the other of these layers (e.g., layer 154) can be made of or can contain FeNi. However, other pairs of materials with different thermal expansion coefficients may also be suitable. One of the layers 152 and 154 having a higher thermal expansion coefficient is also generally designated as an active layer because its expansion / contraction primarily drives the movement of the movable part, while the layer having a lower thermal expansion coefficient is also generally designated as a passive layer because it follows the movement of the other layer. In the arrangement depicted in FIG. 2A, layer 154 (a portion of which is radially outwardly disposed relative to an adjacent portion of layer 152) can be an active layer, and layer 152 can be a passive layer. For example, such an arrangement facilitates or causes movement of the locking portion 156 and / or the movable portion 159 in a radially inward direction when the thermal control member is heated from ambient temperature to skin temperature.

[0070] When, for example, the mechanical lock is released, the locking portion 156 may be moved, in particular radially, by 1 mm or more, 2 mm or more, or 3 mm or more, for example, by 5 mm, relative to the housing.

[0071] When thermal energy is supplied to the thermal coupling surface 130 and the temperature in the member 150 increases, this causes the locking portion 156 of the movable member to move in the direction of the arrow in FIG. 2A (i.e., radially inward). The movable portion 159 also moves. Due to this movement, the mechanical lock is released, as depicted in FIG. 2B (here, for simplicity, the separate layer of the thermal control member 150 is no longer shown). Since the lock has been released by the thermal energy provided to the coupling surface, the movement of the movable member 120 in the proximal direction is now allowed.

[0072] Providing a thermally controlled release of an activation or locking mechanism for authorizing initiation of (delivery) operation of a drug delivery device has the advantage that inadvertent activation (i.e. activation when the device has not been placed in the desired area, in particular on the patient's skin) can be avoided or the risk can at least be significantly reduced.

[0073] It should be noted that the embodiments discussed above (i.e., the release of the mechanical lock depending on the heat input to the thermal coupling surface 130) can also be implemented with an electronic temperature sensor as the thermal control member 150. The mechanical lock can then be released, for example, based on an output signal of the sensor indicating the temperature at the thermal coupling surface, for example by issuing a corresponding command by an electronic control unit.

[0074] The advantage of having a thermal coupling surface at an activation and / or support surface (through which the device contacts the user's skin during use) is that it can be determined whether the device has contacted a surface with a temperature within a predetermined temperature range during operation. The temperature range can be selected so that it includes or consists of typical skin temperatures. For example, the temperature range can be a range between 29°C and 35°C or other common temperatures covering the skin. If the temperature determined before, during and / or after the delivery operation at the activation and / or support surface (e.g., the distal surface of the movable member 120 and / or housing 110 shown in Figures 1A and 1B) is within the predetermined range, it is assumed that a delivery operation of delivering the drug to the user's body has occurred. If the temperature is outside the range, it can be assumed that the application of the drug to the body has not yet occurred. In the latter case, appropriate measures can be taken, such as performing another dose delivery operation (if applicable, under the control of a different person than the first time), issuing an alarm, notifying other people, etc. Of course, this function is preferably implemented in a drug delivery device, which includes an electronic control unit, such as discussed in conjunction with the embodiment of Figure 4.

[0075] FIG. 3 shows another embodiment of a drug delivery device based on a schematic cross-sectional view. The device may be one of the devices discussed previously. FIG. 3 shows the interior of a housing 110 of a drug delivery device or the interior of a container receiving portion 114 within the interior of the housing. Moreover, FIG. 3 shows a portion of a medicament container 160 containing a liquid drug 170 corresponding to a single dose or multiple doses to be delivered by the drug delivery device 100. The container (e.g., a syringe or a cartridge) may include a removable stopper 162 that seals the interior of the container in a proximal direction. When the stopper 162 moves distally within the container, the drug will be discharged through the distal dispensing end of the device. FIG. 3 also shows a plunger 190 of a drive mechanism of the drug delivery device. The plunger is arranged to move the stopper 162 distally during the drug delivery operation, thereby preferably discharging the drug 170 from the container 160 under the bias of a drive spring (not shown).

[0076] The terms "drug" or "medicament" are used synonymously herein and describe a pharmaceutical preparation comprising one or more active pharmaceutical ingredients or a pharmaceutically acceptable salt or solvate thereof and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient ("API") is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used to treat, cure, prevent, or diagnose disease or to otherwise enhance physical or mental health. A drug or medicament may be used for a limited period of time, or periodically for a chronic disease.

[0077] As described below, a drug or medicament may include at least one API or a combination thereof in various types of formulations for treating one or more diseases. Examples of APIs may include small molecules (having a molecular weight of 500 Da or less); polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked DNA and cDNA), RNA, antisense nucleic acids (such as antisense DNA and RNA), small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems (such as vectors, plasmids, or liposomes). Mixtures of one or more drugs are also contemplated.

[0078] In a primary package or "drug container" suitable for use with a drug delivery device, a drug or medicament can be contained. The drug container can be, for example, a cartridge, a syringe, a reservoir or other solid or flexible vessel, which is configured to provide a suitable chamber for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chamber can be designed to store the drug for about 1 month to about 2 years. It can be stored at room temperature (e.g., about 20 ° C) or refrigerated temperature (e.g., from about -4 ° C to about 4 ° C). In some cases, the drug container can be or can include a dual-chamber cartridge, which is configured to store two or more components (e.g., API and diluent, or two different drugs) of a pharmaceutical preparation to be administered separately, one of which is stored in each chamber. In this case, the two chambers of the dual-chamber cartridge can be configured to allow mixing between two or more components before and / or during distribution to the human or animal body. For example, the two chambers may be configured so that they are in fluid communication with each other (e.g., by means of a conduit between the two chambers), and allow the user to mix the two components before dispensing if desired. Alternatively or additionally, the two chambers may be configured to allow mixing when dispensing the components into a human or animal body.

[0079] The medicine or medicament contained in the drug delivery device described herein can be used to treat and / or prevent many different types of medical diseases. The example of disease includes, for example, diabetes or complications associated with diabetes (such as diabetic retinopathy), thromboembolic diseases (such as deep vein or pulmonary thromboembolism). Another example of disease is acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. The example of API and medicine is those described in the following manual: such as the German Doctor's Drug Manual (Rote Liste) in 2014, for example, but not limited to the main group 12 (antidiabetic drugs) or 86 (tumor drugs); and the 15th edition of the Merck Index (Merck Index).

[0080] Examples of APIs for treating and / or preventing type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture thereof. As used herein, the terms "analogs" and "derivatives" refer to polypeptides having a molecular structure that can be formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deleting and / or exchanging at least one amino acid residue present in a naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residues can be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands." In particular, the term "derivative" refers to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Alternatively, one or more amino acids present in the naturally occurring peptide may have been deleted and / or replaced by other amino acids (including non-encodable amino acids), or amino acids (including non-encodable amino acids) have been added to the naturally occurring peptide.

[0081] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and in which the Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0082] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, ); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (insulindegludec, ); B29-N-(N-lithocholyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0083] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are e.g. lixisenatide Exendin-4 Liraglutide (a 39-amino acid peptide produced by the salivary glands of the Gila monster) Semaglutide, Taspoglutide, Albiglutide Dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C, CM-3, GLP-1 Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-401, BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Exenatide-XTEN, and Glucagon-Xten.

[0084] Examples of oligonucleotides are: Mipomersen sodium It is a cholesterol-reducing antisense therapeutic used to treat familial hypercholesterolemia.

[0085] Examples of DPP4 inhibitors are Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0086] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory activity peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, chorionic gonadotropin, tocopherol), somatropine (growth hormone), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin.

[0087] Examples of polysaccharides include glucosaminoglycanes, hyaluronic acid, heparin, low molecular weight heparin or ultra low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20 It is a sodium hyaluronate.

[0088] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen binding portion thereof. Examples of antigen binding portions of immunoglobulin molecules include F (ab) and F (ab') 2 fragments, which retain the ability to bind antigens. The antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., mouse) antibody, or a single-chain antibody. In some embodiments, the antibody has effector functions and can fix complement. In some embodiments, the antibody has reduced or no ability to bind to Fc receptors. For example, the antibody can be an isotype or subtype, an antibody fragment or a mutant, which does not support binding to Fc receptors, for example, it has a mutagenic or missing Fc receptor binding region. The term antibody also includes antigen binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins with cross-binding region orientation (CODV).

[0089] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule, which does not include a full-length antibody polypeptide, but still includes at least a portion of a full-length antibody polypeptide capable of binding an antigen. Antibody fragments can include cleavage portions of full-length antibody polypeptides, although the term is not limited to such cleavage fragments. Antibody fragments that can be used in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies)), monovalent or multivalent antibody fragments (such as bivalent, trivalent, tetravalent and multivalent antibodies), mini antibodies, chelated recombinant antibodies, triabodies or diabodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies and antibodies comprising VHH. Other examples of antigen-binding antibody fragments are known in the art.

[0090] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the correct positioning of the CDR sequences to allow antigen binding. Although the framework region itself is generally not directly involved in antigen binding, as known in the art, certain residues within the framework region of certain antibodies may be directly involved in antigen binding or may affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0091] Examples of antibodies are anti-PCSK-9 mAb (eg, Alirocumab), anti-IL-6 mAb (eg, Sarilumab), and anti-IL-4 mAb (eg, Dupilumab).

[0092] Pharmaceutically acceptable salts of any API described herein are also contemplated for use as drugs or medicaments in drug delivery devices. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0093] Those skilled in the art will appreciate that modifications (additions and / or removals) may be made to the various components of the API, formulations, apparatus, methods, systems and embodiments described herein without departing from the full scope and spirit of the invention, and that the invention encompasses such modifications and any and all equivalents thereof.

[0094] In the depicted embodiment, the thermal coupling surface 130 is thermally and / or mechanically connected to the outer surface of the medication container 160 (e.g., formed by the wall 164 of the container) so that the temperature at the coupling surface indicates the temperature of the drug 170 within the container 160. The wall of the container is suitably thermally conductive. The surface 130 can contact the outer surface of the wall of the container 160. The coupling surface 130 can be formed by a thermal control member 150 (e.g., also a bimetallic member or temperature sensor) or by a thermal conductor 180 (e.g., a metal strip) that is thermally connected to an electronic temperature sensor or a temperature-controlled switch. The sensor can be configured to provide information about the temperature at the thermal coupling surface 130 and therefore about the temperature of the drug within the container.

[0095] If the temperature of the drug is not within the desired range, for example, too hot or too cold so that the user may feel uncomfortable when the drug is to be delivered into the body, the delivery operation can be prevented in a similar manner as discussed above in conjunction with Figures 2A and 2B, for example, mechanically or electronically. The temperature range that is optimally accepted by the user can be close to the normal body temperature of a person, for example, between 35°C and 40°C. Alternatively or additionally, during storage of the device, the temperature of the drug can be recorded by the electronic control unit into an electronic memory, which can be provided in the drug delivery device, so that before the device is operated, it can be determined whether the temperature of the drug remains within a predetermined window or area during storage. In this way, it can be ensured that the temperature has no negative impact on the drug 170 before the device is used.

[0096] Figure 4 shows schematic electronic components of an embodiment of a drug delivery device. The depicted components, or portions thereof, may be present in the context of the device implementing electronics described further above, which may or may not be the case.

[0097] The drug delivery device 100 includes a temperature sensor 200 and a heat conductor circuit (if applicable). The temperature sensor generates an electrical sensor signal in response to thermal energy supplied to the sensor via the thermal coupling surface 130, or changes its characteristics based on the temperature at the coupling surface. The temperature sensor 200 is operatively and preferably conductively connected to the electronic control unit 300. The electronic control unit 300 may be or may include a microcontroller, an integrated circuit (such as an ASIC (application-specific integrated circuit)) or other digital circuit system or control element. The unit may include a memory or storage device to store software for managing the operation of the drug delivery device and / or store data (e.g., temperature data) related to the operation of the drug delivery device. As an alternative or supplement to the sensor 200, the device may include a temperature-triggered switch, for example, a bimetallic member is implemented to selectively close the circuit. The electronic control unit further suitably includes a power supply, such as a battery not explicitly shown. The electronic control unit 300 may be configured to preferably control the operation of the device based on the input received from the temperature sensor 200.

[0098] The drug delivery device 100 may further include an electric drive control member 400, such as a motor. The drive control member 400 can operate a drive mechanism under the control of an electronic control unit, for example, to advance a plunger via a motor. If the input indicating the temperature fed to the electronic control unit by means of the sensor 200 is not within a predetermined range (e.g., a characteristic range of acceptable medicament temperatures for human skin or for delivery), the electronic control unit can, for example, prevent the operation of the drive control member by not issuing a control command to the drive control member that will cause the start of the delivery operation. However, if the temperature is within a predetermined range, the control unit 300 can start the delivery operation. Considerations apply, for example, to releasing a mechanical lock by a drive control member.

[0099] Fig. 4 further shows an evaluation unit, preferably an electronic evaluation unit 500. The evaluation unit 500 can be a unit that is separated from or integrated into the drug delivery device. In the former case, it is preferred that the evaluation unit is connected or connectable to the drug delivery device via a wired or wireless interface (e.g., NFC, Bluetooth or Wi-Fi). This is indicated by the double arrows in Fig. 4. If the unit is integrated into the device, the unit can be integrated into the electronic control unit 300 or operatively coupled to the control unit. The evaluation unit can receive temperature data indicating the temperature at the thermal coupling surface during device operation and / or its startup process. Based on this temperature data, it can be determined whether a drug with an appropriate temperature has been used for delivery operation and / or has entered a structure with a surface (such as the user's skin) with an appropriate temperature. Information on whether the drug and / or the surface to which the drug has been delivered has a temperature within the desired range and / or information about the temperature at the thermal coupling surface can be transmitted to a receiving device, such as a mobile or non-mobile computing device of a user, a caregiver, a parent of a user, or other medically trained or untrained people interested in this information. The communication may be performed via a wired or wireless interface (eg NFC, Bluetooth or Wi-Fi).The information may be used to assess whether the device has been used and / or used correctly.

[0100] In summary, the present disclosure addresses various concepts for using thermal energy in the context of drug delivery devices, which is advantageous for the various reasons already discussed above.

[0101] It is noted that features disclosed only in the introductory part shall be considered to be disclosed also in the part relating to the exemplary embodiments and vice versa.

[0102] The scope of protection is not limited to the examples given above. Any invention disclosed herein is embodied in each novel feature and each combination of features, especially including each combination of any features described in the claims, even if this feature or this feature combination is not explicitly described in the claims or embodiments.

[0103] Reference numerals

[0104] 100 Drug Delivery Devices

[0105] 110 Housing

[0106] 112 Mechanical stop

[0107] 114 Receiving Department

[0108] 116 Surface

[0109] 120 Movable components

[0110] 122 Opening

[0111] 124 Surface

[0112] 130 Thermally coupled surface

[0113] 140 needles

[0114] 150 Thermal Control Components

[0115] 152 Metal Layer

[0116] 154 Metal Layer

[0117] 156 Locking section

[0118] 158 Fixed part

[0119] 159 Removable parts

[0120] 160 Containers

[0121] 162 plug

[0122] 164 wall

[0123] 170 Drugs

[0124] 180 Thermal Conductor

[0125] 190 Plunger

[0126] 200 Temperature Sensor

[0127] 300 Electronic Control Unit

[0128] 400 Electric drive control components

[0129] 500 evaluation units

Claims

1. A drug delivery device (100), comprising: - a first thermal coupling surface, said first thermal coupling surface being arranged and configured to transfer thermal energy, and - a second thermal coupling surface arranged and configured to transfer thermal energy; - a housing (110) and a movable member (120) movably coupled to the housing (110); - a thermal control member (150) thermally conductively connected to the first thermal coupling surface and the second thermal coupling surface, wherein the thermal control member is configured to operate in response to thermal energy transferred through the first thermal coupling surface and the second thermal coupling surface, wherein the first thermal coupling surface is disposed on the housing (110) and the second thermal coupling surface is disposed on the movable member (120) and wherein the drug delivery device is configured to perform a drug delivery operation.

2. The drug delivery device according to claim 1, wherein the thermal control member (150) is an electrical temperature sensor, or an electrical temperature-triggerable switch.

3. The drug delivery device according to claim 1, wherein the thermal control member (150) is an electronic temperature sensor or an electronic temperature triggerable switch.

4. The drug delivery device according to any one of claims 1 to 3, The thermal control component (150) is a bimetallic component.

5. The drug delivery device according to any one of claims 1-3, wherein the thermal control component (150) is designed to operate at a temperature greater than or equal to one of the following values: 22ºC, 23ºC, 24ºC, 25ºC, 26ºC, 27ºC, 28ºC, 29ºC, 30ºC, 31ºC, 32ºC, 33ºC, 34ºC.

6. The drug delivery device according to any one of claims 1-3, wherein the thermal control component (150) is designed to operate at a temperature less than or equal to one of the following values: 44ºC, 43ºC, 42ºC, 41ºC, 40ºC, 39ºC, 38ºC, 37ºC, 36ºC, 35ºC, 34ºC, 33ºC, 32ºC, 31ºC, 30ºC, 29ºC.

7. A drug delivery device according to any one of claims 1-3, wherein the drug delivery device (100) includes a receiving portion (114), which is arranged in the housing or is permanently or releasably connected to the housing, wherein the receiving portion is designed to receive a medication container (160) or wherein the medication container is received in the receiving portion, and wherein the drug delivery device includes a drive mechanism, which is operable to drive the drug delivery operation, wherein the drive mechanism includes at least one movable drive member (190), which is configured to move relative to the housing so as to deliver the medication from the medication container through the dispensing opening of the drug delivery device during the drug delivery operation.

8. The drug delivery device according to claim 7, wherein the first thermal coupling surface is associated with the receiving portion of the drug delivery device (100) such that the thermal coupling surface is thermally conductively connected to the medicament container when the medicament container is arranged in the receiving portion.

9. The drug delivery device according to any one of claims 1-3, wherein the drug delivery device (100) is configured such that a mechanical lock is released in response to thermal energy supplied to the thermal coupling surface (130), wherein the mechanical lock prevents movement of an element of the device when established, and allows movement of the element when the mechanical lock is released, wherein the element is a trigger member for initiating the drug delivery operation, and wherein the trigger member is a trigger button or a needle shield.

10. The drug delivery device of claim 9, wherein the movement is for operation of the drug delivery device.

11. The drug delivery device according to any one of claims 1-3, wherein the drug delivery device (100) comprises an activation surface (124), wherein the activation surface is arranged to be contacted by a user to initiate the drug delivery operation of the drug delivery device, and wherein the thermal coupling surface (130) is accessible on the activation surface.

12. The drug delivery device according to any one of claims 1-3, wherein the drug delivery device comprises a support surface (116), which is arranged to contact the skin of a user or patient during and / or before the drug delivery operation, wherein the first thermal coupling surface and / or the second thermal coupling surface is accessible on the support surface.

13. The drug delivery device according to any one of claims 1 to 3, wherein the drug delivery device (100) comprises an electronic control unit (200), wherein the thermal control member (150) is operatively coupled or coupleable to the electronic control unit, and wherein the drug delivery device is configured such that the electronic control unit permits initiation of the drug delivery operation only if the temperature at the thermal coupling surface (130) is within a predetermined temperature range.

14. The drug delivery device according to any one of claims 1-3, wherein the drug delivery device (100) is configured to store and / or transmit data regarding the temperature at the thermal coupling surface.

15. The drug delivery device according to any one of claims 1-3, wherein the drug delivery device (100) is configured to store and / or transmit data about the temperature at the thermal coupling surface when the drug delivery operation has been initiated and / or when the drug delivery operation is being performed.

16. The drug delivery device of any one of claims 1-3, wherein a region laterally surrounding or adjacent to the thermal coupling surface is formed of a material having a lower thermal conductivity than the thermal coupling surface.

17. A system comprising an evaluation unit (500) and a drug delivery device (100) according to any one of claims 1 to 16, the evaluation unit being integrated into the drug delivery device or being operatively coupled to the drug delivery device, wherein the drug delivery device is configured to transmit temperature data indicative of the temperature at the first thermal coupling surface and / or the second thermal coupling surface to the evaluation unit.

18. The system according to claim 17, wherein the drug delivery device is configured to transmit temperature data indicative of the temperature at the first thermal coupling surface and / or the second thermal coupling surface during a delivery operation to the evaluation unit.

19. A method for evaluating a drug delivery device (100) according to any one of claims 1 to 16, the method comprising the step of comparing the temperature at the first thermo-coupling surface and / or the second thermo-coupling surface to a predetermined temperature or a predetermined temperature range.

20. The method of claim 19, wherein the temperature is derived from the thermal control component.

21. The method of claim 19, wherein the temperature is derived from the thermal control component before, during, or after a delivery operation.

22. A drug delivery device (100), comprising: - a first thermal coupling surface, said first thermal coupling surface being arranged and configured to transfer thermal energy, and - a second thermal coupling surface arranged and configured to transfer thermal energy; - a housing (110) and a movable member (120) movably coupled to the housing (110); - a thermal control member (150) thermally conductively connected to the first thermal coupling surface and the second thermal coupling surface, wherein the thermal control member is configured to operate in response to thermal energy transferred through the first thermal coupling surface and the second thermal coupling surface, and wherein the drug delivery device is configured to perform a drug delivery operation, wherein the first thermal coupling surface is arranged on the housing (110) and the second thermal coupling surface is arranged on the movable member (120), The drug delivery device (100) is configured such that a mechanical lock is released in response to thermal energy supplied to the second thermal coupling surface, wherein the mechanical lock prevents movement of an element of the device when established and allows movement of the element when the mechanical lock is released.

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