Injection device

Abstract

This disclosure relates to an infusion device (1) for infusing a drug dose, wherein the infusion device is - A housing (10) surrounding a container receiving space (20) sized to accommodate a drug container (40) containing a drug, which has an outer surface (18), - A heat conductor (30) attached to or integrated with the housing (10), wherein the heat conductor (30) has an inner contact surface (32) adjacent to or extending into the container receiving space (20) so as to make direct mechanical contact with the drug container (40) when the drug container (40) is placed in the container receiving space (20).

Description

Technical Field

[0001] The present disclosure relates to the field of injection devices, particularly to the field of pen-type injectors for injecting single or multiple doses of a drug. In another aspect, the present disclosure relates to a method for measuring the temperature of each drug disposed inside a drug container or an injection device.

Background Art

[0002] Drug delivery devices for setting and administering single or multiple doses of a liquid drug are well known in the art per se. Generally, such devices have purposes similar to those of a conventional syringe.

[0003] Drug delivery devices such as pen-type injectors must meet a plurality of user-specific requirements. For example, in the case of a patient suffering from a chronic disease such as diabetes, the patient may be physically debilitated and may also have reduced vision. Therefore, particularly drug delivery devices for home drug treatment must be structurally robust and easy to use. Furthermore, the operation and general handling of the device and its components must be clear and easy to understand. Such an injection device should provide for the setting and subsequent administration of doses of drugs of the same or different sizes. Moreover, the dose setting and dose administration procedures must be easy to operate and unambiguous.

[0004] A patient suffering from a particular disease may need to inject a specific amount of a drug via a pen-type injection syringe or by an autoinjector.

[0005] Some drug delivery devices or injection devices provide for the selection of variable-sized drug doses and the injection of pre-set doses. Other injection devices provide for the setting and administration of a fixed dose. In this case, the amount of drug to be injected according to a given prescription schedule is always the same and does not change or cannot be changed over time.

[0006] Some infusion devices are implemented as reusable infusion devices in which the user replaces the drug container, such as a cartridge. Other infusion devices are implemented as disposable infusion devices. In disposable infusion devices, the entire infusion device is intended to be discarded once the contents, i.e., the drug, have been used up.

[0007] Certain injectable medications or drugs need to be stored at a relatively low temperature until use, but should not be infused at this storage temperature. This is because the drug's effectiveness may be reduced and / or injecting a drug at a very low temperature may be more painful. To avoid this, patients are usually advised to remove the infusion device containing the drug from the refrigerated storage and allow it to warm at room temperature for a certain period of time. Since the true temperature of the drug when it is completely enclosed is unknown, the waiting time must be chosen with a wide safety margin. However, as a matter of course, it is not possible to guarantee that the drug will have reached the correct temperature at the time of infusion.

[0008] Therefore, it would be beneficial to actively measure the temperature of the drug or drug reservoir inside the infusion device. This would allow the patient to reduce the required waiting time and confirm that the desired temperature has actually been reached. In general, it would be desirable to provide a reliable, simple, and cost-effective way to measure the temperature of the drug reservoir. This would allow the user to reduce the required waiting time and confirm that the drug has reached the desired temperature before infusion.

[0009] With some injectors, such as auto-injectors, or other handheld injectors, such as pen-type injectors that allow the user to individually set and administer drug doses, the container is easily assembled inside the housing of the injector. Typically, drug containers, for example, in the form of barrels or syringes filled with liquid drugs, have only fairly limited mechanical contact with the housing of the injector. Therefore, it is not possible to directly access the drug container from outside the injector to perform temperature measurements. [Overview of the project] [Problems that the invention aims to solve]

[0010] Therefore, it is even more desirable to enable temperature measurement of the drug and / or drug container from outside the infusion device while the drug or drug container is located inside the housing of the infusion device. [Means for solving the problem]

[0011] In one embodiment, an infusion device for injecting a drug dose is proposed. The infusion device comprises a housing having an outer surface. The housing comprises a container receiving space and / or encloses a container receiving space. The container receiving space is sized to accommodate a drug container, which contains an injectable drug. The infusion device further comprises a thermal conductor attached to or integrated with the housing. The thermal conductor comprises an inner contact surface that is adjacent to or extends into the container receiving space and makes direct mechanical contact with the drug container when the drug container is located inside the housing and / or occupies the container receiving space.

[0012] Typically, a thermal conductor is a dedicated thermal element or thermal member configured to provide a thermal bridge between a drug container and the housing of an infusion device. In this way, at least a portion of the housing, typically a portion that is mechanically in contact with the thermal conductor, can be thermally coupled to the drug container located or stored inside the housing. By providing a thermal bridge, the thermal conductivity between the outer surface of the housing and the drug container, and therefore between the drug located inside the drug container and the outer surface of the housing, can be increased. In this way, the thermal conductivity between the outer surface of the housing and the drug located inside the drug container when the drug container is located or positioned inside the housing can be improved.

[0013] This allows for the direct measurement of the temperature of a dedicated portion on the outer surface of the housing, which is thermally in contact with the drug container and therefore the drug via a heat conductor and thus a corresponding thermal bridge. As a result, the dedicated portion of the housing, i.e., the portion of the outer surface of the housing that is thermally in contact with the heat conductor, enables and supports fairly accurate and direct temperature measurement of the drug container from outside the housing of the infusion device. This temperature measurement indicates the temperature of the drug located within the drug container.

[0014] In contrast, a heat conductor between the housing and the container receiving space is particularly beneficial in improving the transfer of thermal energy from the external environment of the infusion device to the drug container. Therefore, when the ambient temperature of the infusion device is subjected to a rapid change, the time interval required for the drug in the drug container to reach a predetermined temperature can be significantly reduced by the heat conductor. Due to the increased thermal conductivity between the drug container or the drug and the outer surface of the housing, an infusion device stored in a refrigerated area for a relatively long period of time may heat up substantially faster when moved to a room temperature environment compared to an infusion device without such a heat conductor.

[0015] In further examples where the thermal conductor is attached to or integrated within the housing and further configured to make direct mechanical contact with the drug container, increased and improved support can be provided with respect to the mechanical fastening or securing of the drug container inside the housing of the infusion device. Here again, the thermal conductor provides two functions: it increases the thermal conductivity between the drug and the outer surface of the housing; and at the same time, it provides a mechanically stable mounting or support for the drug container inside the infusion device.

[0016] In some examples, the heat conductor is provided as a separate component or member that can be attached to or fastened to the housing of the injection device. In other examples, the heat conductor is easily integrated into the housing. In some examples, the heat conductor can be injection molded into the housing of the injection device. Typically, the housing of the injection device contains or is made of plastic material. The heat conductor may be implemented as a separate component made of a material exhibiting a thermal conductivity greater than that of the base material of the housing.

[0017] Further examples include thermal conductors having thermal conductivity of more than 0.5 W / (mK), more than 0.5 W / (mK), more than 1 W / (mK), more than 5 W / (mK), more than 10 W / (mK), more than 100 W / (mK), more than 200 W / (mK), more than 300 W / (mK), more than 350 W / (mK), or more than 400 W / (mK).

[0018] In some cases, the thermal conductivity is greater than 5 W / (mK) and less than 420 W / (mK). In some cases, the thermal conductivity of the thermal conductor material is greater than 100 W / (mK) and less than 420 W / (mK). Typically, the thermal conductor material of the thermal conductor contains or exhibits a thermal conductivity greater than that of any of the following plastic materials: polyethylene, polypropylene, and polyoxymethylene.

[0019] Further examples include, a thermal conductor, at least one of the following: a metal, a plastic material having a thermally conductive dopant, a polymer having a thermally conductive dopant, an elastomer material having a thermally conductive dopant, a glass having a thermally conductive dopant, a coiled metal wire, a metal ribbon which may be wound into a coil, and a material having a thermally conductive coating.

[0020] In some cases, when the heat conductor is made of a metallic material, the heat conductor may be integrally formed. The heat conductor may be constructed from within the metal and may be mounted as an integrally molded or integrated component, either manually attached to the housing of the injection device or integrated into the housing of the injection device by, for example, insert molding.

[0021] In other examples, for instance, if the heat conductor includes a plastic, polymer, or elastomer material having a thermally conductive dopant, the heat conductor may be implemented as an injection-molded component. The heat conductor may be provided as a separate injection-molded component assembled or attached to the housing by a mechanical assembly process. In other examples, each heat conductor may be integrated into or fastened to the housing by an injection molding process of two or more components.

[0022] In other examples, when integrated into a housing, the housing of the injection device may be made of a thermal conductive material having a thermal conductivity of over 0.5 W / (mK), over 0.5 W / (mK), over 1 W / (mK), over 5 W / (mK), over 10 W / (mK), over 100 W / (mK), over 200 W / (mK), over 300 W / (mK), over 350 W / (mK), or over 400 W / (mK). In that case, the housing itself may provide the respective thermal conductor.

[0023] In some examples, when using a thermal conductivity dopant or a thermal conductivity coating, the dopant material typically exhibits a relatively high thermal conductivity, for example, greater than 5 W / (mK), greater than 10 W / (mK), greater than 100 W / (mK), greater than 200 W / (mK), greater than 300 W / (mK), greater than 350 W / (mK), or greater than 400 W / (mK). Here, carbon, graphene, or metal particles can function as or be used as respective thermal conductivity dopants within the bulk of a plastic material, a polymer material, or an elastomer material, or within respective coatings.

[0024] In this way, by utilizing respective thermal conductivity dopants, the thermal conductivity of respective dopant-embedded materials such as various plastic materials, polymer materials, or elastomer materials can be substantially increased to function as a heat conductor of the injection device of the present invention.

[0025] According to a further example, the housing of the injection device defines a longitudinal direction. The heat conductor is compressible or deformable with respect to a radial direction that extends substantially perpendicular to the longitudinal direction. In some examples, the housing is rather slender in shape. The housing can extend along an axial direction. In this way, the heat conductor can then be compressible or deformable with respect to a radial direction that extends substantially perpendicular to the axial direction.

[0026] The compressibility or deformability of the heat conductor can be particularly beneficial in providing a configuration that compensates for geometric tolerances of the drug container and the heat conductor within the housing of the injection device. In some examples, the geometric size of the drug container may be subject to certain tolerances. By providing a compressible or deformable heat conductor within at least a specific range, for example, within the range of expected tolerances of the housing and / or the drug container, such geometric tolerances can be effectively compensated, thereby still providing comprehensive, and thus sufficient, mechanical contact and mechanical contact with thermal conductivity between the drug container and the heat conductor.

[0027] The same may apply to housings, which may also be subject to specific geometric tolerances. Similarly, compressible or deformable thermal conductors can be used to effectively compensate for each tolerance of the housing. By providing such compressible or deformable thermal conductors, the mechanical forces applied to the drug container when it is placed inside the housing may not exceed a predetermined maximum allowable value. Therefore, when using compressible or deformable thermal conductors, for example, during the final assembly of the drug container into the infusion device, any optional external force applied to the drug container can be reduced to a clearly defined minimum value that is beneficial for the integrity of the container. Furthermore, compressible or deformable thermal conductors can play a role in providing clearly defined mechanical fixation of the drug container inside the housing of the infusion device.

[0028] In a further example, the housing of the injection device has side walls, and the heat conductor is positioned between the side walls and the drug container, or between the side walls and the container receiving space, and is surrounded or enclosed by the side walls. Typically, the heat conductor can be sized to fit into the gap between the drug container and the inside of the side wall of the housing. In this way, the heat conductor provides an effective thermal bridge between the drug container and the housing. The heat conductor can at least partially bridge the gap between the outer container surface and the inside of the side wall of the housing.

[0029] The longitudinal range of the thermal bridge may be the same as the corresponding longitudinal range of the drug container or container receiving space. In some examples, for instance, almost the entire longitudinal extension of the barrel of the drug container may be in direct mechanical contact with the surrounding heat conductor, at least partially. In this way, the thermal conductivity between the outer surface of the drug container and the inside of the side wall of the housing can be maximized. This is useful not only for measuring the actual temperature of the drug container and therefore the drug contained therein, but also for increasing the transfer of thermal energy from the outside of the housing of the injection device toward the drug container.

[0030] In this way, for example, when taken out from the refrigerated area, the time interval until the drug reaches a predetermined temperature can be shortened. The waiting time for the patient to perform the injection can be shortened respectively.

[0031] In a further example, the heat conductor has a longitudinal range shorter than the longitudinal range of the drug container. In some examples, the longitudinal range of the heat conductor is at least 50% of the longitudinal range of the drug container or the container receiving space. In other examples, the longitudinal range of the heat conductor is at least 30% of the longitudinal range of the drug container or the container receiving space. In a further example, the longitudinal range of the heat conductor is at least 20% of the longitudinal range of the container receiving space or the drug container.

[0032] It is further contemplated that the injection device comprises a number, and thus at least two, three, or even more than that, of heat conductors, all of which are in thermal contact with the drug container and the housing of the injection device. When using a plurality of heat conductors, each heat conductor can be arranged offset from each other in the longitudinal and / or circumferential directions, for example, with respect to the tubular or cylindrical geometric arrangement of the drug container.

[0033] For example, using the first and second heat conductors can be beneficial for improving the mechanical fastening of the drug container inside the housing of the injection device. Here, the first heat conductor can be arranged, for example, close to or adjacent to the distal end or the first longitudinal end of the tubular portion of the drug container, and the second heat conductor can be arranged near or at the proximal, and thus the second longitudinal end, of the molded portion of the drug container.

[0034] In some examples, the heat conductor can completely or at least partially surround the outer periphery of the drug container. In the case of a tubular drug container, the heat conductor can comprise an annular body or an annular structure having an inner diameter that matches the outer diameter of the tubular barrel of the drug container.

[0035] In a further example, the side wall of the housing has an inward recess. The heat conductor is placed within the recess on the inside of the side wall of the housing. Such an arrangement is beneficial in at least two situations. Firstly, the recess on the inside of the side wall of the housing leads to a reduction in the thickness of the housing in the region of the recess. Thus, assuming that the thermal conductivity of the material of the side wall of the housing is less than that of the heat conductor, the thermal coupling between the heat conductor and the outer surface of the housing can be improved. Secondly, the recess on the inside of the side wall of the housing allows the heat conductor to be fixed precisely and easily inside the housing. In some examples, the geometric arrangement of the recess is complementary to the geometric arrangement of the heat conductor. This allows the heat conductor to be fitted and fixed inside the recess on the inside of the side wall of the housing of the injection device.

[0036] Therefore, recesses on the inside of the side walls are particularly useful for the mechanical fastening or fixing of heat conductors within the housing. Furthermore, if each recess is provided, heat conductors can be easily retrofitted to the housing of the infusion device to improve the thermal conductivity between the drug container and the outer surface of the housing. In this way, the exact same housing type can be used for the manufacture and assembly of infusion devices with or without such heat conductors. Housings of infusion devices intended for use with specific drugs can then be configured individually, and each may be provided with its own heat conductor.

[0037] In a further example, at least a portion of the heat conductor protrudes inward from the inside of the side wall of the infusion device housing. In this way, when the drug container is assembled inside the housing, a clear mechanical contact can be established between the inner contact surface of the heat conductor and the outer surface of the drug container. Furthermore, the inwardly protruding heat conductor can also mechanically stabilize and secure the drug container inside the housing of the infusion device. In this way, the inwardly protruding heat conductor provides two functions: it improves the thermal conductivity between the outer surface and the drug container, and it also helps to secure the drug container inside the housing of the infusion device.

[0038] In a further example, a recess provided on the inside of the side wall of the housing of an injection device comprises a through-opening that extends through the entire side wall of the housing. Here, the heat conductor can effectively fill the opening or extend through the through-opening. In this way, the heat conductor can be involved with or contribute to the outer surface of the housing. The heat conductor may be directly accessible from the outside of the housing of the injection device by reaching through the through-opening or by filling the through-opening, and thus by extending through the side wall of the housing. Such a configuration is particularly useful for measuring the temperature of the heat conductor, and by extension, the temperature of the drug container that is thermally in contact with the heat conductor.

[0039] Furthermore, the thermal conductors contributing to the outer surface of the injection device housing help improve and facilitate the transfer of thermal energy from the environment of the injection device to the drug container or drug, and into the drug.

[0040] In a further example, the heat conductor comprises an outer contact surface that is coplanar with the outer surface of the housing. Here, the heat conductor, which may extend through a through-opening in the housing and optionally completely fill the through-opening, contributes to the outer surface of the housing in a fairly concise manner. By not protruding from the outer surface of the housing and being coplanar with the outer surface of the housing, the heat conductor does not affect the handling of the injection device, which the user may be accustomed to. Moreover, a configuration in which the heat conductor is coplanar on or within the outer surface of the housing allows and supports the attachment of temperature measuring devices, such as temperature measuring tags or electronic labels, to the outer surface of the housing.

[0041] Furthermore, because the heat conductor extends through the side wall of the housing, the user can even manually detect the temperature of the drug container thermally in contact with the heat conductor by, for example, mechanically bringing a temperature-sensitive body part such as a finger or cheek directly into contact with the outer contact surface of the heat conductor.

[0042] If the outer contact surface of the heat conductor can be manually perceived as considerably cold, the patient or user of the infusion device receives direct indication that the drug container, and therefore the drug contained within it, is still at a temperature level that would be undesirable at the time of infusion.

[0043] A heat conductor coplanar with the outer surface of the housing can also enhance or improve the visual design of the injection device. The heat conductor can be distinguished from the rest of the outer surface of the housing by color and / or with respect to its tactile structure or texture. In this way, the presence of a heat conductor in the injection device will be immediately apparent to those skilled in the art. Furthermore, the appearance of the heat conductor on or within the outer surface of the housing of the injection device provides a fairly direct method for performing temperature measurement, for example, by utilizing an auxiliary temperature measuring device.

[0044] In further examples, the inner contact surface of the heat conductor has a shape complementary to the outer surface of the drug container. In some examples, the drug container comprises a tubular barrel. In this case, the inner contact surface of the heat conductor may also be tubular in shape, or may comprise a tubular portion configured to establish a relatively large surface contact with the outer surface of the drug container.

[0045] In tubular or cylindrical drug containers, the inner contact surface may have a tubular or semi-tubular structure that maximizes the mutual contact surface between the heat conductor and the outer surface of the drug container.

[0046] In a further example, the infusion device comprises a drug container fixed or assembled inside the housing. The drug container is in direct mechanical and thermal contact with a heat conductor. The drug container may be a pre-filled drug container. Thus, the drug container is readily filled with liquid drug before being assembled inside the housing of the infusion device.

[0047] The infusion device is implemented as a disposable infusion device, and the drug container can be easily assembled inside. Disposable infusion devices are intended to be discarded as a whole after use. Use of the infusion device may include a single dose or multiple doses of the drug. In some examples, the infusion device is implemented as a fixed-dose infusion device. The infusion device may be implemented to infuse a single dose or multiple doses of equal size. In other examples, the infusion device is configured to individually set a single dose or multiple doses of different dose sizes and subsequently infuse each dose.

[0048] In some examples, the infusion device is implemented as a reusable infusion device, where the housing may be configured to provide an opening that allows for disassembly or replacement of the drug container.

[0049] In some examples, the drug container is permanently fixed within the housing of the infusion device. In other examples, the drug container may be movably positioned within the infusion device. In some examples, the infusion device is implemented as a so-called auto-injector, which provides movement of the injection needle relative to the housing of the infusion device to automatically puncture the patient's skin and subsequently administer a dose of the drug. In some examples, the drug container may have a needle permanently and non-removably fixed at the outlet of the drug container. In other examples, the infusion device may have a needle assembly that is removablely connectable to the infusion device and / or the drug container.

[0050] In any case, the proximal end of the injection needle can be located inside or inserted into the outlet end of the drug container in order to administer or inject a drug dose by moving the drug container stopper distally, i.e., toward the outlet end of the drug container. The displacement of the drug container stopper is typically caused by a drive mechanism of the injection device, which may include a piston rod that contacts the drug container stopper by the action of mechanical thrust. The drug container stopper typically seals the inside of the tubular barrel of the container on the side of the proximal end opposite to the drug container's dispensing outlet.

[0051] In a further example of an injection device, the housing and / or injection device is provided with markings on the outer surface of the housing. The location of the markings coincides with the location of a heat conductor inside the housing. Therefore, the portion of the housing marked visually or tactilely indicates a dedicated portion of the housing that is particularly suitable for performing temperature measurements indicating the temperature of a drug container located inside the housing.

[0052] The portion of the housing designated by the markings is in mechanical and / or thermal contact with the heat conductor and thus contributes to a mechanical bridge between the outer surface of the housing and the drug container.

[0053] In a further example, the injection device includes a temperature sensor fastened to the outside of the housing and in thermal contact with a heat conductor. Typically, the temperature sensors may be arranged in an overlapping configuration, with markings optionally provided on the outer surface of the housing. In some examples, the markings on the outer surface of the housing may be provided by a heat conductor extending through a through-opening in the side wall of the housing, as described above. Here, the heat conductor itself provides a visible marking to provide fairly accurate temperature measurement of the heat conductor and, consequently, the drug container.

[0054] In some examples, the temperature sensor is part of a machine-readable label configured to be attached to the outer surface of the injection device. The machine-readable label may comprise a substrate, such as a flexible substrate, which may be elongated and tubular in shape, and is configured to be wrapped around and / or fastened to the outer surface of the housing. The temperature sensor may be part of an auxiliary device that can be attached to or fastened to the housing of the injection device. The auxiliary device may comprise the respective temperature sensor. The auxiliary device may be implemented as either a machine-readable label or an injection monitoring device capable of recording and / or electronically storing single or repeated use of the injection device. In some examples, the auxiliary device may be capable of quantitatively measuring, detecting, and / or recording or storing the size of the dose, as well as the time or date each dose was injected by the injection device.

[0055] In some examples, machine-readable labels include electronic circuits. These electronic circuits may be implemented as integrated circuits. They may be printed on the substrate of the machine-readable label. The electronic circuits may include a processor or controller and a temperature sensor connected to the processor or controller. Furthermore, the machine-readable label may include an antenna or communication module connected to the processor and capable of communicating with an external electronic device. In some examples, the electronic circuit is a passive electronic circuit capable of, for example, extracting or collecting electrical energy or power from a radiation source of an external electronic device. The communication interface may include, for example, a wireless antenna capable of transmitting RF signals. In some examples, the machine-readable label may be implemented as an RFID tag, an NFC tag, or a Bluetooth low-energy device tag, which can be used to measure temperature.

[0056] In some cases, machine-readable labels are passive NFC or RFID labels that do not have their own energy source. Machine-readable labels may be driven by an external electromagnetic field provided by a reading device, such as an external electronic device. Typical external electronic devices that cooperate with or communicate with machine-readable labels may be implemented as smartwatches, smartphones, tablet computers, or any other computing or smart devices.

[0057] The energy required to operate the temperature measurement can be obtained from an electromagnetic RF field provided by the reading device. Such energy is typically obtained by the antenna of the machine-readable label. Once the machine-readable label has received sufficient electrical energy from the reading device, it becomes operational to perform temperature measurements via a temperature sensor connected to the machine-readable label's processor. The temperature signal provided by the temperature sensor can be appropriately processed by the machine-readable label's processor and transmitted wirelessly to an external electronic device or reader, which can then be operational to display or communicate the measured temperature to the user of its respective device.

[0058] Machine-readable labels that provide temperature measurement may be commercially available. They can be implemented as temperature-measuring NFC tags with an integrated temperature sensor. Temperature measurement can be performed at relatively short time intervals when the NFC tag is activated, i.e., when activated by an external reading device.

[0059] An adhesive layer may be provided on the machine-readable label, which allows the label to be fixed to a dedicated portion on the outer surface of the housing that is in thermal contact with the heat conductor. In some examples, the machine-readable label is a flexible label. The machine-readable label may be wrapped around the injection device, or it may be fixed to the injection device by adhesive, for example.

[0060] Machine-readable and temperature-sensing labels or any other auxiliary devices can be readily attached to the infusion device at the time of delivery to the patient or end consumer. In other examples, the infusion device and the auxiliary temperature measuring device may be provided separately to the patient or to the user of each device. In this case, the infusion device typically has markings on its outer surface indicating the area where temperature measurement is to be performed. The reading device, whether in the form of an auxiliary dose measuring device or a machine-readable label, may have an indicator of complementary shape, so that when the auxiliary device or machine-readable label is mounted on the housing of the infusion device, the indicator aligns with the marking, and the temperature sensor aligns properly with the heat conductor.

[0061] In another aspect, the disclosure also relates to a method for measuring the temperature of a drug located inside a drug container, the drug container being located inside the housing of an infusion device as described above. The method includes the step of indirectly measuring the temperature of the drug by measuring the temperature of a heat conductor using a temperature sensor, where the heat conductor provides a thermal bridge between the drug located inside the drug container, and thus inside the housing of the infusion device, and a temperature sensor that is accessible only from the outer surface of the housing of the infusion device. The method for measuring the temperature of the drug is typically performed using an infusion device as described above. Therefore, all the features, effects, and advantages described above with respect to the infusion device also apply equally to the method for measuring the temperature of the drug.

[0062] In another aspect, the disclosure also relates to a method for heating or cooling a drug located inside a drug container, wherein the drug container is located inside the housing of an infusion device as described above. The method includes the step of moving the infusion device out of a first area and into a second area, where the temperature of the first area is different from the temperature of the second area. Thereafter, thermal energy is exchanged or transferred between the second area and the drug container via a heat conductor of the infusion device.

[0063] This method is suitable for relatively rapid heating or cooling of a drug container when the drug container is located inside an infusion device, and when the housing and / or the assembly of the drug container inside the housing has relatively low thermal conductivity. In some examples, the housing of the infusion device is made of a plastic material having relatively low thermal conductivity, e.g., less than 0.5 W / (mK). In addition, an air gap may be provided between the side wall of the drug container and the inside of the side wall of the housing, and this air gap also exhibits relatively low thermal conductivity. A thermal conductor can be used to provide a thermal bridge between the outer container surface and the outer surface of the housing of the infusion device.

[0064] In some cases, the temperature of the first area is lower than the temperature of the second area. This is the case, for example, when the infusion device is removed from the refrigerated area and stored at room temperature before the infusion procedure is performed. It is at this time that the heat conductor facilitates the transfer of heat or thermal energy from the second area to the drug container. Conversely, when the infusion device is returned to the refrigerated area after use, the temperature of the first area is higher than the temperature of the second area. Therefore, the respective cooling thermal energy is transferred from the second area to the drug container. Thus, the cooling effect of the drug container after the infusion device is returned to the refrigerated area can be accelerated.

[0065] In another aspect, the disclosure also relates to a thermal conductor for an infusion device. The infusion device comprises a housing that defines a container receiving space sized to accommodate a drug container filled with a drug. The thermal conductor comprises an inner contact surface that is adjacent to or extends into the container receiving space and makes direct mechanical contact with the drug container when the drug container is placed within the container receiving space.

[0066] Here, the heat conductor may be provided as a separate component rather than being assembled within or integrated with the injection device as described above. Otherwise, the heat conductor may be substantially identical to the heat conductor of the injection device as described above. To that extent, any features, effects, and advantages described above in relation to an injection device with a heat conductor also apply equally to the heat conductor in such an applicable manner.

[0067] Further examples include thermal conductors having thermal conductivity of more than 0.5 W / (mK), more than 0.5 W / (mK), more than 1 W / (mK), more than 5 W / (mK), more than 10 W / (mK), more than 100 W / (mK), more than 200 W / (mK), more than 300 W / (mK), more than 350 W / (mK), or more than 400 W / (mK).

[0068] In a further example, the thermal conductor includes at least one of medical materials and plastic materials (corresponding to claim 3). Moreover, as described above in relation to the thermal conductor of the injection device, the insulated thermal conductor may also be compressible or deformable with respect to radial movement in the longitudinal direction of the housing.

[0069] Further examples include, a thermal conductor, at least one of the following: a metal, a plastic material having a thermally conductive dopant, a polymer having a thermally conductive dopant, an elastomer material having a thermally conductive dopant, a glass having a thermally conductive dopant, a coiled metal wire, a metal ribbon which may be wound into a coil, and a material having a thermally conductive coating.

[0070] In a further example, the heat conductor may comprise a cylindrical body that can be configured to at least partially surround or remain around the drug container.

[0071] In another example, the heat conductor may include a geometric shape and geometric arrangement for fitting into a recess on the inside of the side wall of the injection device and / or for filling a through-opening provided in the side wall of the injection device.

[0072] In a further example, the heat conductor includes an outer contact surface configured to establish thermal contact with a temperature sensor configured to be positioned on the outer surface of the housing of the injection device.

[0073] In further examples, the heat conductor can be attached to or fastened to the outer surface of the side wall of the barrel of the drug container. The drug container may be provided as a drug cartridge, a drug coupler, a syringe, or a vial.

[0074] In a further example, the heat conductor can be attached to the housing of the injection device, or the heat conductor can be integrated into the housing of the injection device.

[0075] In another embodiment, the disclosure further relates to a drug container comprising a barrel at least partially filled with an injectable drug. The barrel comprises, for example, a tubular side wall. The barrel may have a distal outlet for discharging the drug from the barrel's internal volume, and may further have a proximal end provided with a movable plunger or stopper for discharging a liquid drug through the outlet. The outlet may be provided with an injection needle for injecting the drug into biological tissue. The drug container further comprises a heat conductor as described above, attached to or fastened to the outer surface of the barrel's side wall. To that extent, all the effects, features and advantages described above relating to the heat conductor apply equally to a drug container comprising such a heat conductor. Typically, the drug container and the heat conductor are configured to be assembled inside the housing of an injection device, as described above. To that extent, all the effects, features and advantages described above relating to an injection device apply equally to a drug container, and vice versa.

[0076] In this specification, the terms “distal” or “distal end” refer to the end of the injection device facing the injection site in a human or animal. The terms “proximal” or “proximal end” refer to the end of the injection device opposite to the injection site in a human or animal.

[0077] The terms “drug” or “pharmaceutical” are used herein as synonyms and refer to a formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally pharmaceutically acceptable carriers. A pharmacoactive ingredient ("API") is, in its broadest sense, a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or pharmaceuticals are used to treat, cure, prevent or diagnose diseases, or otherwise to improve physical or mental health. Drugs or pharmaceuticals may be used over a limited period or, in the case of chronic diseases, regularly.

[0078] As described below, drugs or pharmaceuticals may contain at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs include small molecules with molecular weights of 500 Da or less, polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids or liposomes. Mixtures of one or more drugs are also possible.

[0079] Drugs or pharmaceuticals may be contained within a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide a chamber suitable for storing one or more drugs (e.g., short-term or long-term storage). For example, in some cases, the chamber may be designed to store drugs for at least one day (e.g., one day to at least 30 days). In some cases, the chamber may be designed to store drugs for about one month to about two years. Storage may be carried out at room temperature (e.g., about 20°C) or refrigerated temperature (e.g., about -4°C to about 4°C). In some cases, the drug container may be, or include, a dual-chamber cartridge configured to store two or more components of a pharmaceutical preparation to be administered (e.g., an API and a diluent, or two different drugs) separately in each chamber. In such cases, the two chambers of the dual-chamber cartridge may be configured to allow mixing of two or more components before and / or during administration to the body of a human or animal. For example, the two chambers may be configured to be in fluid communication with each other (e.g., by a conduit between the two chambers), allowing the two components to be mixed if desired by the user before administration. Alternatively or additionally, the two chambers may be configured to allow mixing when the components are administered into the body of a human or animal.

[0080] Drugs or agents contained within drug delivery devices as described herein may be used to treat and / or prevent many different types of medical disorders. Examples of disorders include, for example, diabetes mellitus or complications associated with diabetes mellitus, such as diabetic retinopathy, and thromboembolic disorders such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders include acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are listed in the Rote Liste 2014, for example, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and handbooks such as the Merck Index, 15th edition.

[0081] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes mellitus or complications thereof include insulin, e.g., human insulin, or insulin analogs or derivatives; glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or their analogs or derivatives; dipeptidyl peptidase-4 (DPP4) inhibitors; or pharmaceutically acceptable salts or solvated compounds thereof; or any mixture thereof. As used herein, the terms “analog” and “derivative” refer to polypeptides having a molecular structure that can be formally derived from the structure of a spontaneously occurring peptide, e.g., the structure of human insulin, by deleting and / or replacing at least one amino acid residue occurring in the spontaneously occurring peptide, and / or by adding at least one amino acid residue. The amino acid residue added and / or replaced may be a coding amino acid residue, another spontaneously occurring residue, or a purely synthetic amino acid residue. Insulin analogs are also referred to as “insulin receptor ligands.” In particular, the term "derivative" refers to a polypeptide having a molecular structure that can be formally derived from the structure of a naturally occurring peptide, such as the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are bonded to one or more amino acids. Optionally, one or more amino acids present in the naturally occurring peptide may be substituted with other amino acids, including deletions and / or non-coding amino acids, or amino acids, including non-coding amino acids, may be added to the naturally occurring peptide.

[0082] Examples of insulin analogs include Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glardine); 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 proline at position B28 may be replaced with Asp, Lys, Leu, Val or Ala, and Lys at position B29 may be replaced with Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0083] Examples of insulin derivatives include, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin These are B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-litocoryl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0084] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (Exendin-4, Byetta®, Bydureon®), and Hiramonster (Gila Monster's salivary glands produce a 39-amino acid peptide, liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), r-exendin-4, CJC-1134-PC, PB-1023, TTP-054, langlenatide / HM-11260C (efpeglenatide), HM-15211, CM-3, GLP-1 eligene, ORMD-0901, NN-9423, NN-9709, NN-9924, NN These include -9926, NN-9927, Nodexene, Biador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodotide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Chilzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-XTEN.

[0085] Examples of oligonucleotides include mipomersen sodium (Kynamro®), a cholesterol-lowering antisense drug for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport syndrome. Examples of DPP4 inhibitors include linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0086] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides such as gonadotropins (follitropin, lutropin, choriongonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadrelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin, and their antagonists.

[0087] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin, or very low molecular weight heparin, or their derivatives, or polysulfated forms, such as sulfated 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. Examples of hyaluronic acid derivatives are Hylan GF 20 (Synvisc®) and sodium hyaluronate.

[0088] As used herein, the term “antibody” refers to an immunoglobulin molecule or its antigen-binding region. Examples of antigen-binding regions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind to antigens. Antibodies may be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., mouse) antibodies, or single-chain antibodies. In some embodiments, antibodies may have effector function and be capable of immobilizing complement. In some embodiments, antibodies may have reduced or no ability to bind to Fc receptors. For example, an antibody may be an isotype or subtype, antibody fragment, or mutant having mutations or deletions in the Fc receptor-binding region that do not support binding to the Fc receptor, for example. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulin (TBTI) and / or bivariable region antibody-like binding proteins having crossover binding region orientation (CODV).

[0089] The terms “fragment” or “antibody fragment” refer to polypeptides derived from antibody polypeptide molecules (e.g., antibody heavy and / or light chain polypeptides) that do not contain the full-length antibody polypeptide but still contain at least a portion of a full-length antibody polypeptide capable of binding to an antigen. Antibody fragments may include cleavage portions of full-length antibody polypeptides, but the term is not limited to such cleavage fragments. Examples of antibody fragments useful in the present invention include Fab fragments, F(ab')2 fragments, scFv (single-stranded Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments, e.g., bispecific, trispecific, quadrispecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments, e.g., bivalent, trivalent, quadrivalent and multivalent antibodies, minibodies, chelated recombinant antibodies, tribodies or vibodies, intrabodies, nanobodies, small module immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0090] The term "complementarity-determining region," or "CDR," refers to a short polypeptide sequence within the variable region of both heavy and light polypeptides, primarily responsible for mediating specific antigen recognition. The term "framework region," rather than the CDR sequence itself, refers to an amino acid sequence within the variable region of both heavy and light polypeptides, primarily responsible for maintaining the proper arrangement of the CDR sequence to enable antigen binding. While the framework region itself typically does not directly participate in antigen binding, as is well known in the art, specific residues within the framework region of a particular antibody can directly participate in antigen binding or influence the interaction ability of one or more amino acids in the CDR with the antigen.

[0091] Examples of antibodies include anti-PCSK-9 mAbs (e.g., alirocumab), anti-IL-6 mAbs (e.g., sarilumab), and anti-IL-4 mAbs (e.g., dupilumab).

[0092] Any pharmaceutically acceptable salt of any API described herein is intended for use with drugs or pharmaceuticals in drug delivery devices. Examples of pharmaceutically acceptable salts include acid addition salts and basic salts.

[0093] Those skilled in the art will understand that modifications (additions and / or deletions) of various components of the APIs, formulations, apparatus, methods, systems, and embodiments described herein may be made without departing from the full scope and spirit of the invention, including any or all of such modifications and their equivalents.

[0094] Exemplary drug delivery devices may include needle-based infusion systems, such as those described in Table 1 of Section 5.2 of ISO 11608-1:2014(E). As described in ISO 11608-1:2014(E), needle-based infusion systems can be broadly classified into multi-dose container systems and single-dose (with partial or full discharge) container systems. Containers may be replaceable or integrated non-replaceable containers.

[0095] As further described in ISO 11608-1:2014(E), a multi-dose container system may include a needle-based infusion device with replaceable containers. In such a system, each container holds multiple doses, and its size may be fixed or variable (pre-configured by the user). Another multi-dose container system may involve a needle-based infusion device with an integrated non-replaceable container. In such a system, each container holds multiple doses, and its size may be fixed or variable (pre-configured by the user).

[0096] As further described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based infusion device with replaceable containers. In one example of such a system, each container holds a single dose, and the entire deliverable volume is dispensed (total discharge). In a further example, each container holds a single dose, and a portion of the deliverable volume is dispensed (partial discharge). As also described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based infusion device with an integrated, non-replaceable container. In one example of such a system, each container holds a single dose, and the entire deliverable volume is dispensed (total discharge). In a further example, each container holds a single dose, and a portion of the deliverable volume is dispensed (partial discharge).

[0097] Examples of injection devices having a heat conductor for temperature measurement, and methods of using them, are described in more detail below with reference to the drawings. [Brief explanation of the drawing]

[0098] [Figure 1] A schematic example of an injection device comprising a drug container and a heat conductor is shown. [Figure 2] This is a three-dimensional diagram of another injection device combined with a machine-readable electronic label and an external electronic device for temperature measurement. [Figure 3] A schematic diagram of a thermal bridge, electronic label, and external electronic device for temperature measurement performed on a heat conductor is shown. [Figure 4] A schematic example of a heat conductor is shown below. [Figure 5] Here is another example of a heat conductor. [Figure 6] A schematic example of an injection device in which the heat conductor is located inside the housing of the injection device is shown. [Figure 7] Figure 6 shows an example of the drug container being placed inside the housing. [Figure 8]Another schematic example shows a thermal conductor mounted or integrated within the housing of the injection device. [Figure 9] Further examples of housing and thermal conductor arrangements are shown. [Figure 10] This diagram schematically shows the change in the temperature of a drug container over time after it has been removed from the refrigerated area. [Figure 11] A flowchart showing how to measure the temperature of a drug is provided. [Figure 12] This is a cross-sectional view of an example of a heat conductor. [Figure 13] This is a cross-section of another example of a heat conductor. [Figure 14] Here is another example of a heat conductor. [Modes for carrying out the invention]

[0099] Figures 1 and 2 show an example of an injection device 1, which is implemented, for example, as a handheld pen-type injector. The injection device 1 comprises a housing 10. Inside the housing 10 is a container receiving space 20, which is shown in Figure 6. The container receiving space 20 is typically defined by the external dimensions or geometric arrangement of a drug container 40 configured to be received and housed inside the housing 10 of the injection device 1. When assembled inside the housing 10, the drug container 40 completely occupies the container receiving space 20.

[0100] The drug container 40 may comprise a tubular barrel 42 characterized by tubular side walls 41. The drug container 40 may have an outlet 43 at or near its distal end 45, and may further comprise a movable stopper 49 in or near its proximal longitudinal end 48 on the opposite side. In some examples, the outlet 43 at the distal end 45 of the drug container 40 comprises a septum 47 that can be punctured by an injection needle 46. Here, the injection needle 46 may be operable to penetrate the septum 47 and access the liquid drug 50 stored inside the drug container 40.

[0101] In some examples, the injection needle 46 may be movable or removable to the outlet 43. Here, the injection needle 46 may belong to or be part of a needle assembly (not shown) configured to be removable to the housing 10, for example, the distal end of the cartridge holder portion of the housing 10 of the injection device 1.

[0102] In other examples, the injection needle 46 is permanently fixed to the outlet 43. The injection needle may be accessible through the outlet and permanently fastened to the barrel 42. The injection needle may be embedded in the material of the barrel 42. The barrel 42 typically contains a pharmaceutically inert material, such as a glassy material like glass.

[0103] A drug container 40 as shown herein is tubular and elongated in shape. Its distal end 43 may coincide with an outlet 43. Opposite the distal end 45 is a proximal end 48 sealed by a movable stopper 49. To dispense a dose of drug through the outlet 43 and therefore through an infusion needle 46 provided at or extending through the outlet 43, the infusion device 1 typically comprises a drive mechanism 4 including a piston rod 5, the piston rod being displaceable distally and therefore toward the outlet 43 of the drug container 40. The piston rod 5 is configured to engage with or bias the stopper 49 distally to increase the fluid pressure inside the barrel 42, thereby dispensing a clearly defined amount or dose of drug, the magnitude of which correlates with the displacement of the stopper 49 relative to the side wall 41 of the drug container 40.

[0104] The housing 10 comprises at least one container support 21, 22 configured to mechanically engage with the drug container 40. The container support 21, 22 can be used to mechanically secure the drug container 40 inside the housing 10. In the example of Figure 1, the container support 21 is located at or near the distal end 45 of the drug container 40. An optional container support 22 is located at or near the shoulder of the drug container 40. Both container supports 21, 22 are configured to provide axial or longitudinal support for the drug container 40 inside the housing 10 to counteract the distally directed dosing force applied to the stopper 49 of the drug container 40 by the piston rod 5. For example, further support structures may be provided to hold the drug container 40 in a dedicated position inside the housing 10 not only with respect to the longitudinal direction (z) but also to the radial direction (r).

[0105] The injection device 1 may include a dose dial 7 that allows the user to set a dose and / or activate the drive mechanism 4. Furthermore, a trigger 6 may be provided, which can trigger a dose injection procedure. In the injection device 1 implemented as an auto-injector, the trigger may be provided at the distal end 2 of the injection device, for example, in the form of a needle sleeve or needle shroud. In this case, the trigger 6' may be integrated with the distal end of the housing 10. In other examples, the trigger 6 is provided as a button at or near the proximal end 3 of the injection device 1, which is illustrated in Figure 2.

[0106] The distal end 2 of the infusion device 1 may be provided with a removable or detachable protective cap 8. The cap 8 may be configured to cover and / or protect at least one of the outlet 43 and the infusion needle 46.

[0107] Optionally, the infusion device 1 is provided with a window 9. In particular, in a variable dose setting device, the window 9 can be operated to visually display the size of the currently set and to be administered drug dose.

[0108] Except for the heat conductor 30, the details of which are described in more detail below, the infusion device 1 as shown herein represents a wide variety of different types of infusion devices, comprising a housing having a container receiving space for accommodating a drug container, and further operable to inject a dose of drug provided inside the drug container into biological tissue.

[0109] An infusion device 1 as described herein is provided with a heat conductor 30 attached to or integrated with the housing 10. The heat conductor 30 includes an inner contact surface 32 that is adjacent to or extends into the container receiving space 20 and directly mechanically contacts the drug container 40 when the drug container 40 is placed in the container receiving space 20 of the housing 10 of the infusion device 1.

[0110] As shown in Figure 1, the heat conductor 30 plays the role of providing a thermal bridge between the outer surface 44 of the drug container 40 and the outer surface 18 of the housing 10 of the injection device 1. Without the heat conductor 30, the thermal contact or bonding between the outer surface 18 of the housing 10 and the drug container 40 would be considerably poor. Therefore, it may be quite difficult to measure the temperature of the drug 50 or the drug container 40 from outside the housing 10. Moreover, the considerably low thermal conductivity between the outer surface 18 of the housing 10 and the drug container 40 is detrimental to the rapid and desired heating or cooling of the drug 50.

[0111] Generally, the temperature of the injection device 1 and / or drug container 40 can be measured using an auxiliary electronic device such as an electronic label 100 schematically shown in Figure 2. The electronic label 100 comprises a substrate 101 which may be flexible. The substrate 101 may be implemented as a flexible foil 102 which will be wrapped around the outer surface 18 of the housing 10. The electronic label 100 may be provided with an adhesive, for example, having a self-adhesive layer, so that it can be permanently attached to the outer surface 118 of the housing 10. The electronic label 100 may be implemented as a passive NFC tag or RFID tag. The electronic label may include an antenna 108, a temperature sensor 110, and a processor 106. For example, an electronic circuit 104 comprising a temperature sensor 110, a processor 106, and an antenna 108 may be printed on the substrate 101.

[0112] When the electronic label 100 is attached to the housing 10, it may be positioned, fastened, or fixed to the housing 10 such that the temperature sensor 110 overlaps with a marking 19 provided on the outer surface 18, thereby tactilely marking or indicating the position of the heat conductor 30 of the injection device 1. In some examples, the marking 19 may even be provided by the heat conductor 30 itself.

[0113] The marking 19 visible on the outer surface 18 of the housing 10 may coincide with the outer contact surface 34 of the heat conductor 30. In this way, when the electronic label 100 is properly attached to the outer surface 18 of the housing 10, the temperature sensor 110 may overlap with the marking 19 and / or the heat conductor 30, thereby providing a fairly direct thermal coupling between the temperature sensor 110 and the drug container 40 via a thermal bridge, which is provided by direct mechanical, and therefore thermal, contact between the drug container 40, the heat conductor 30, and the temperature sensor 110.

[0114] The electronic label 100 may be operable to communicate with an external electronic device 150. The external electronic device 150 may be implemented as a wireless reader operable to exchange electromagnetic signals with the electronic label 100. The external electronic device 150 includes a communication interface 158 configured to exchange signals with the antenna 108 of the electronic label 100.

[0115] Typically, the communication interface 158 includes an NFC reader or RFID reader for supplying electromagnetic energy to the passive electronic label 100 in order to wake up and activate the electronic label 100. Furthermore, the communication interface 158 is operable to receive electromagnetic signals from the antenna 108, which indicate sensor signals from the temperature sensor 110.

[0116] The external electronic device 150 is typically operable to process sensor signals received from the electronic label 100, and further operable to visually display or audibly provide information regarding the temperature measured by the temperature sensor 110. Each temperature display 154 may be provided on the display 152 of the external electronic device 150.

[0117] An example of a thermal bridge provided by the heat conductor 30 is shown in more detail in Figure 3. The heat conductor 30 is located inside the housing 10 of the injection device 1. The heat conductor may be integrated with the side wall 11 of the housing 10 or may contribute to the side wall 11 of the housing 10. The heat conductor 30 has an inner contact surface 32 that is complementary in shape to the outer container surface 44. In this way, the mutual contact area between the heat conductor 30 and the side wall 41 of the drug container 40 can be maximized so that the thermal conductivity between the side wall 41 or barrel 42 of the drug container 40 and the heat conductor 30 is improved.

[0118] The thermal conductor 30 exhibits a specific thermal conductivity, typically greater than that of the housing 10. The thermal conductivity of the material of the thermal conductor 30 may be greater than that of undoped plastic or glass. This thermal conductivity may also be greater than that of undoped, and therefore conventional, plastic materials such as polyethylene, polypropylene, or polyoxymethylene.

[0119] The thermal conductor 30 further includes an outer contact surface 34 opposite the inner contact surface 32. The outer contact surface 34 of the thermal conductor 30 may be in direct or indirect thermal contact with the temperature sensor 110 of the electronic label 100. Optionally, a portion of the side wall 11 of the substrate 101 and / or housing 10 may be provided between the outer contact surface 34 and the temperature sensor 110. The temperature sensor 110 is connected to the processor 106. The measurement signal generated or modified by the temperature sensor 110 can be transmitted wirelessly to the external electronic device 150 via the interaction between the antenna 108 and the communication interface 158 of the external electronic device 150.

[0120] Typically, the external electronic device 150 is implemented as a smartwatch, a smartphone, or a tablet computer. A software application, such as an app, is typically provided, configured to convert or calculate the measurement signal received from the electronic label 100 into a visual indicator of temperature on the display 152 of the external electronic device 150.

[0121] As further shown in Figures 3 and 4, the heat conductor 30 has a distal end 35, which, in the assembled state, faces toward the distal end 45 of the drug container 40 inside the housing 10. The heat conductor 30 further has a proximal end 38 that faces toward the proximal end 48 of the drug container 40. The longitudinal range of the heat conductor 30 may be the same as the longitudinal range of the corresponding drug container. In some examples, the longitudinal range, and therefore the distance between the distal end 35 and the proximal end 38 of the heat conductor 30, may be greater than 10%, greater than 20%, greater than 30%, or greater than 50% of the longitudinal range of the drug container 40. In this way, a substantial portion of the outer container surface 44 of the barrel 42 can be in direct mechanical, and therefore thermal, contact with the heat conductor 30.

[0122] Furthermore, with respect to the circumferential direction of the drug container 40, the heat conductor 30 may be confined to or extend around the entire circumference of the drug container 40. Here, the heat conductor 30 may comprise an annular closed ring, or an annular or tubular closed structure. In further examples, the heat conductor may have a circumferential size greater than 180° of the tubular circumference of the barrel 42. In some examples, the circumferential range of the heat conductor 30 is between 90° and 270° of the circumference of the outer container surface 44 of the barrel 42.

[0123] In any case, by using the heat conductor 30, for example, when the injection device is removed from a refrigerated area and held or stored at room temperature before injection, the time interval from when the injection device is subjected to a rapid change in the ambient temperature until the drug container 40 reaches thermal equilibrium with the environment can be minimized.

[0124] As particularly shown in Figure 4, in some examples the heat conductor 30 may comprise a tubular sleeve characterized by a hollow cylindrical inner contact surface 32 and a corresponding cylindrical outer contact surface 34. The tubular body 31 of the heat conductor 30 may be made of a metal exhibiting relatively high thermal conductivity, such as aluminum, copper, or brass. The heat conductor 30 as shown in Figure 4 may be made of a solid, and therefore rigid, material. It may be relatively hard or rigid.

[0125] The heat conductor 30 may be mounted as a separate component inside the housing 10 of the injection device. Here, the outer contact surface 34 may engage with the inner side 12 of the side wall 11 of the housing 10. In some examples, the heat conductor 30 may be injection molded into or within the injection-molded housing 10. The heat conductor may also be insert-molded to provide a heat-conductive insert inside the side wall structure 11 of the housing 10.

[0126] In the example shown in Figure 5, the body 31 of the heat conductor 30 is also cylindrical, but it is provided with a longitudinal slit 36 ​​that extends through the entire body 31 of the heat conductor 30. The longitudinal slit 36 ​​provides the heat conductor 30 with a certain degree of elasticity, compressibility, or deformability. Here, if the heat conductor 30 is made of a relatively rigid metal, the heat conductor 30 may be deformable to at least some extent, and thus it becomes possible to adapt the heat conductor to the unavoidable manufacturing tolerances or geometric tolerances of both the housing 10 and the drug container 40.

[0127] In the example shown in Figure 12, the thermal conductor 30 includes a body 31 made of a plastic material 52, the body 31 being provided with an embedded thermally conductive dopant material 53. The dopant may include relatively small particles in the sub-millimeter range, and even nanoparticles having relatively high thermal conductivity. In some examples, the dopant material may be one of metal, carbon, or graphene.

[0128] In a further example in Figure 13, the heat conductor 30 comprises a body 31 provided with a heat conductive coating 54, where the coating 54 may be provided on the inner contact surface 32 and on the outer contact surface 34. In a further example in Figure 14, the heat conductor 30 may comprise a body 31 in the form of a coiled ribbon 56 forming one or more windings 58, where the body 31 may comprise a relatively thin material sheet, such as a relatively thin metal sheet layer, which can be wrapped around a drug container 40.

[0129] As shown in the figure, the ribbon 56 comprises an inner winding 58' and an outer winding 58. The windings 58, 58' may be provided in a densely packed arrangement such that the opposing and mutually adjacent surfaces of the ribbon 56, and therefore of the individual windings 58, 58', have relatively large surface contact. The ribbon 56 and the number of windings allow the radial thickness of the heat conductor 30 to be easily adapted to various requirements. The body 31 of the heat conductor 30 may comprise one or more wires wound around or capable of being wound around the drug container 40 instead of the ribbon 56.

[0130] If the heat conductor ribbon or wire structure is pre-installed inside the housing 10, it can be attached, fixed, or fastened to the inside 12 of the side wall 11. Alternatively, the heat conductor ribbon or wire 56 of the heat conductor 30 may be integrated into or embedded within the side wall 11 of the housing 10, for example, by insert molding.

[0131] Examples in Figures 6 to 9 show various arrangements of the heat conductor 30 inside the housing 10. In the figures, the size of the heat conductor 30 is enlarged relative to the drug container 42 in order to show the thermal bridge in more detail.

[0132] In Figures 6 and 7, the inner surface 12 of the side wall 11 of the housing 10 is provided with a recess 14. The heat conductor 30 is positioned within the recess 14. The heat conductor 30 can completely fill the recess 14 such that its inner contact surface 32 protrudes from the inner surface 12 of the side wall 11. In this way, the inner contact surface 32 may be directly adjacent to the container receiving space 20 of the housing 10, or it may even enter into or extend into it. In the example of Figure 7, the container receiving space 20 is completely occupied by each pharmaceutical container 40. As a result, the inner contact surface 32 of the heat conductor 30 is in direct contact with the outer container surface 44 of the barrel 42 of the pharmaceutical container 40, and is therefore in mechanical and thermal contact. The geometric arrangement of the inner contact surface 32 is complementary to the shape of the outer container surface 44.

[0133] The inwardly protruding surface portion of the heat conductor 30 also provides mechanical stability for mounting the drug container 40 within the housing 10. Here, the heat conductor 30 may further provide a substantial portion of a mounting structure or mounting structure for holding and securing the drug container 40 inside the housing 10.

[0134] Providing a recess 14 on the inner side 12 of the side wall 11 is further beneficial in that the thickness of the side wall 11 in the region of the recess 14 is thinner compared to the region of the side wall 11 offset from the recess 14. Therefore, the bottom 15 of the recess 14 is relatively thin. In examples where the side wall 11 has a relatively low thermal conductivity, the thinness of the side wall 11 in the region of the recess 14 is beneficial in providing an improvement in thermal conductivity across the side wall 11 compared to a configuration without such a recess.

[0135] In a further example shown in Figure 8, the recess 14 includes a through-opening 16 that extends through the entire side wall 11. Here, the heat conductor 30 extends through the through-opening 16. The outer contact surface 34 of the heat conductor 30 may be coplanar with the outer surface 18 of the housing 10 shown in Figure 8. In this way, direct mechanical and thermal contact can be provided between the heat conductor 30 and the temperature sensor 110 or electronic label 100. Thus, the thermal conductivity of the thermal bridge provided between the drug container 40 and the outer surface 18 of the housing 10 can be further increased.

[0136] In the example of Figure 8, a number of heat conductors 30 may be provided, each having only a partially cylindrical shape when viewed circumferentially. Here, the side wall 11 of the housing 10 may have a number of through-openings 16, each of which is filled with or provided with an individual heat conductor 30. Otherwise, for example, in the case of a cylindrical heat conductor 30 as shown in Figure 4, and in the configuration of Figure 8, the heat conductor 30 may be provided between two individual housing components of the injection device 1, for example, between a proximal housing component 10' configured to house or receive the drive mechanism 4 and a protective cap 8 configured to cover the distal end of the injection device 1.

[0137] In contrast, in the examples of Figures 6 and 7, the recess 14 having a closed bottom 15 may have a circumferential groove that matches the size and shape of the heat conductor 30 placed therein.

[0138] In a further example shown in Figure 9, the heat conductor 30 is positioned on the inner surface 12 of the side wall 11, and the side wall 11 may not have a recess 14. Here, the outer contact surface 34 of the heat conductor 30 is in direct contact with the fairly straight inner surface 12 of the side wall 11 of the housing 10.

[0139] Figure 9 shows another configuration or example of the relative arrangement of the drug container 40' and the housing 10 of the injection device 1. Here, the side wall 41' of the drug container 40', particularly the barrel 42', is in direct mechanical contact with the inside 12 of the side wall 11 of the housing 10. To increase the thermal conductivity of the side wall 11 of the housing 10, a thermal conductor 30' is embedded within the structure of the side wall 11. Here, the thermal conductor 30' may include a metal piece or an equivalent thermal conductive material piece. It is completely embedded within the material of the surrounding side wall 11. It may be insert-molded within the side wall 11. Here, the inner contact surface 32' and / or outer contact surface 34' of the thermal conductor 30 may be covered by the material of the side wall 11.

[0140] Figure 10 shows graphs 170 and 172, which illustrate the time variation of the temperature of the drug container 40 measured with and without the heat conductor 30, as described above. Graph 170 reflects the situation with the heat conductor 30, and graph 172 represents the situation without the heat conductor 30.

[0141] Graphs 170 and 172 show the time-dependent rise in the temperature of the drug container 40 immediately after the injection device 1, which contains the drug container 40, is removed from the refrigeration area at time T=0. As is immediately apparent from a comparison of the two graphs 170 and 172, the transfer of thermal energy into the drug container 40 is more rapid in the injection device 1 equipped with the thermal conductor 30. Here, after approximately 10 minutes, the drug container reached a temperature level 171 close to room temperature. In the situation reflected in graph 172, after the same time interval, the temperature level 173 of the drug container is significantly lower compared to graph 170.

[0142] On the other hand, by using the heat conductor 30, when the injection device 1 containing the agent is subjected to a rapid change in ambient temperature, the agent 50 is heated and cooled more quickly. Furthermore, the heat conductor 30 can significantly improve the accuracy of temperature measurements.

[0143] The flowchart in Figure 11 schematically illustrates a method for measuring the temperature of the drug 50 located inside the drug container 40. Here, in the first step 200, an infusion device 1 as described herein is provided to the user. In step 202, the infusion device 1 is removed, for example, from a refrigerated area and stored or provided at room temperature. In step 204, the drug container inside the housing 10 of the infusion device 1 is subjected to heating due to exposure to a new or high-temperature environment. A thermal conductor provides a thermal bridge between the drug container 40 and the outer surface 18 of the housing 10, thereby accelerating the exchange of thermal energy between the drug container 40 and the environment.

[0144] In step 206, for example, as shown in Figure 2, the heat conductor 30 is used to perform the temperature measurement described above. Optionally, the measurement step 206 can be repeated multiple times to accurately monitor temperature changes, such as the heating process of the drug container.

[0145] Since the thermal conductivity of the heat conductor, and therefore the thermal conductivity of the thermal bridge between the outer surface 18 of the housing 10 and the drug container 40, is not infinite, even when using the heat conductor 30, there may be a certain delay or offset between the actual temperature of the drug container and the temperature that can be measured on the outer surface 18 of the housing 10.

[0146] To compensate for such time delays or temperature offsets, the measurement software of the external electronic device 150 may be calibrated as appropriate. Calibration can be performed using experimental data obtained from reference measurements of the temperature and temperature progression of the drug 50 inside the drug container 40, and current measurements, such as those described herein, performed simultaneously. Reference measurements, for example, the actual temperature of the drug inside the drug container, may be performed by any suitable non-contact temperature measurement, for example, based on a temperature measurement using infrared radiation. [Explanation of symbols]

[0147] 1. Injection device 2. Distal end 3. Proximal end 4. Drive mechanism 5 Piston rod 6 Triggers 7. Dosage Dial 8. Protective cap 9 windows 10 Housing 11 Side wall 12. Inner self 14 recess 15 Bottom 16 Through-opening 18 Outer surface 19 Marking 20 Container receiving space 21 Container support 22 Container support 30 Thermal Conductors 31 Main unit 32 Inner contact surface 34 Outer contact surface 35 Distal end 36 slits 38 Proximal end 40. Drug containers 41 Side wall 42 barrels 43 Exit 44 Outer container surface 45 Distal end 46 Injection needle 47 Septum 48 Proximal end 49 Stopper 50 medications 52 Plastic Materials 53 Dopant 54 Coating 56 Wire / Ribbon 58 coiled body 100 electronic labels 101 Base material 102 Foil 104 Electrical Circuits 106 Processors 108 Antenna 110 Temperature Sensor 150 External Electronic Devices 152 displays 154 Temperature display 158 Communication Interfaces 170 Graphs 171 Temperature Levels 172 Graphs 173 Temperature Levels

Claims

1. An infusion device (1) for injecting a drug dose, wherein the infusion device is - A housing (10) that surrounds a container receiving space (20) having an outer surface (18) and sized to accommodate a drug container (40) containing the drug, - An injection device (1) comprising: a heat conductor (30) attached to or integrated with the housing (10), wherein the heat conductor (30) has an inner contact surface (32) adjacent to or extending into the container receiving space (20) so as to make direct mechanical contact with the drug container (40) when the drug container (40) is placed in the container receiving space (20).

2. The injection device (1) according to claim 1, wherein the heat conductor (30) includes a heat conductive material having a thermal conductivity of more than 0.5 W / (mK), more than 0.5 W / (mK), more than 1 W / (mK), more than 5 W / (mK), more than 10 W / (mK), more than 200 W / (mK), more than 300 W / (mK), more than 350 W / (mK), or more than 400 W / (mK).

3. The injection device (1) according to claim 1 or 2, wherein the thermal conductor (30) includes at least one of a metal, a plastic material having a thermally conductive dopant, a polymer having a thermally conductive dopant, an elastomer material having a thermally conductive dopant, a glass having a thermally conductive dopant, a coiled metal wire, a metal ribbon, and a material having a thermally conductive coating.

4. The injection device (1) according to any one of claims 1 to 3, wherein the housing (10) defines a longitudinal direction (z), and the heat conductor (30) is compressible or deformable in a radial direction (r) perpendicular to the longitudinal direction (z).

5. The injection device (1) according to any one of claims 1 to 4, wherein the housing (10) includes a side wall (11), and the heat conductor (30) is disposed between the side wall (11) and the drug container (40) or between the side wall (11) and the container receiving space (20).

6. The injection device (1) according to claim 5, wherein the side wall (11) has a recess (14) on its inner surface (12), and the heat conductor (30) is disposed within the recess (14).

7. The injection device (1) according to any one of claims 1 to 6, wherein at least a portion of the heat conductor (30) protrudes inward from the inner surface (12) of the side wall (11).

8. The injection device (1) according to claim 7, wherein the inner contact surface (32) of the heat conductor (30) protrudes inward from the inner side (12) of the side wall (11).

9. The injection device (1) according to any one of claims 6 to 8, wherein the recess (14) has a through opening (16) extending through the side wall (11), and the heat conductor (30) extends through the through opening (16).

10. The injection device (1) according to any one of claims 1 to 9, wherein the heat conductor (30) comprises an outer contact surface (34) that is coplanar with the outer surface (18) of the housing (10).

11. The injection device (1) according to any one of claims 1 to 10, wherein the inner contact surface (32) of the heat conductor (30) has a shape complementary to the outer surface (44) of the drug container (40).

12. The injection device (1) according to any one of claims 1 to 11, wherein the inner contact surface (32) of the heat conductor (30) is hollow cylindrical in shape.

13. The infusion device (1) according to any one of claims 1 to 12, wherein the heat conductor (30) comprises a cylindrical body (31) configured to at least partially surround the drug container (40) or to be secured around the drug container (40).

14. The injection device (1) according to any one of claims 1 to 13, wherein the heat conductor (30) comprises an annular body (31) or an annular structure having an inner diameter that matches the outer diameter of the tubular barrel (42) of the drug container (40).

15. The injection device (1) according to any one of claims 1 to 14, further comprising the drug container (40) fixed within the housing (10) and in direct mechanical and thermal contact with the heat conductor (30).

16. The injection device (1) according to any one of claims 1 to 15, further comprising a marking (19) on the outer surface (18), wherein the position of the marking (19) coincides with the position of the heat conductor (30) inside the housing (10).

17. The injection device (1) according to any one of claims 1 to 16, further comprising a temperature sensor (110) fastened to the outside of the housing (10) and in thermal contact with the heat conductor (30).

18. A method for measuring the temperature of a drug located inside a drug container (40) disposed inside the housing (10) of an injection device (1) according to claim 15, the method comprising the step of indirectly measuring the temperature of the drug by measuring the temperature of the heat conductor (30) via a temperature sensor (110).

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