Monitoring unit

Abstract

Monitoring unit (200, 302) for a drug delivery device, wherein the monitoring unit comprises: - a case (202, 300), - a monitoring circuit (400) arranged in the housing (202, 300) and capable of detecting and monitoring functions of the drug delivery device when the drug delivery device is in use, - a fastening mechanism which is provided with releasable locking elements (208, 306) for releasable fastening to the drug delivery device, wherein the fastening mechanism has a number of flexible locking elements (208, 306) which are arranged to interact with matching locking elements on the drug delivery device, - a mechanical interface (231, 318) arranged to interact with a matching mechanical interface located on a drug delivery device, and - an activation switch (242, 320) which is arranged in the mechanical interface and is arranged to activate the monitoring circuit (400), wherein the drug delivery device is provided with an activator element (114) which is arranged in the mechanical interface and is operationally connected to a drive element (98, 104) of the drug delivery device, wherein, when the drug delivery device is used, the drive element (98, 104) pushes the activator element (114) in a distal direction during the dose delivery sequence, thereby acting on the activation switch (242, 320).

Description

TECHNICAL AREA

[0001] The present invention relates to a monitoring unit which is arranged and operated in conjunction with a drug delivery device, wherein the monitoring unit is detachably attached to the drug delivery device. BACKGROUND OF THE INVENTION

[0002] With the increasing use of self-medication devices, which are operated by patients themselves, the need for information for healthcare professionals, such as doctors and nurses, is growing. They need to know how patients are adhering to their treatment regimens. Therefore, there is an increasing need to monitor regimen progress, and in this regard, a number of medication delivery devices have been equipped with additional functions to monitor device usage, store monitoring data, and transmit the stored data to external devices for further processing.

[0003] An example is disclosed in document WO 2014 / 128156. It comprises a drug delivery device equipped with a logging module capable of detecting the movement of components within the drug delivery device. According to one embodiment, the logging module is equipped with a rotation sensor capable of counting the number of steps a dial ring is rotated relative to the fixed housing, both when a dose is set and when a dose is dispensed.

[0004] The number of steps determined by the rotary sensor can be used for various informational purposes. For example, the time of setting and dispensing a dose can be recorded, allowing the time elapsed since the last dose to be calculated. The dose size can also be detected by the rotary sensor. The acquired data can then be transmitted to an external device such as a smartphone or similar device. Communication between the module and the smartphone preferably takes place via NFC technology.

[0005] One disadvantage of the solution described above is that the module is an integrated part of the medication dispensing device. Since such a module consists of several components and is therefore quite expensive to manufacture, it is only suitable for a medication dispensing device that can be used a large number of times with replaceable medication containers—a so-called reusable medication dispensing device. It is not suitable for disposable medication dispensing devices that are discarded after use.

[0006] Another solution is disclosed in document WO 2014 / 020008. It comprises an add-on device designed to be connected to a drug delivery device, which has a housing with a matching unit configured to securely but releasably enclose the drug delivery device housing. The add-on device is equipped with optical and acoustic sensors for collecting information from the drug delivery device. The add-on device also has a user interface for entering and displaying information. The add-on device is designed to monitor the operation of the device, such as setting a dose and / or injecting a dose, using acoustic sensors. The add-on device can communicate with a blood glucose monitoring system via a communication technology such as Bluetooth.

[0007] Even though the housing is preferably designed to tightly enclose the housing of a specific drug delivery device, the connection is not uniquely assigned, and the accessory can be connected to a number of drug delivery devices with similar housing dimensions. Therefore, there is a risk that a user might use the accessory with a drug delivery device other than the one intended. Consequently, the information received from the accessory could be corrupted and unreliable.

[0008] It would be advantageous if the drug delivery device could be equipped with monitoring units that are more versatile, yet still provide accurate and correct data from a drug delivery device designed for use with the monitoring unit. BRIEF DESCRIPTION OF THE INVENTION

[0009] In the present application, the term “distal part / end” refers to the part / end of the device or the parts / ends of the device elements that are / are furthest from a dispensing or administration site of the patient when the device is in use. Accordingly, the term “proximal part / end” refers to the part / end of the device or the parts / ends of the device elements that are / are closest to the dispensing or administration site of the patient when the device is in use.

[0010] The following description uses the term "intelligent or smart devices." In this context, smart devices can be electronic devices equipped with processors capable of running computer programs and possessing storage space for programs and data retrieved from various external sources. It is further understood that smart devices are equipped with communication systems capable of communicating with data networks to access various databases. This access can occur via the internet, so-called cloud services, and / or databases directly connected to and accessed through local networks. Furthermore, it is assumed that smart devices in this context possess some form of human-machine interface for two-way communication.The human-machine interface can include screens, keyboards, microphones, speakers, and input / output ports for connecting peripherals. Furthermore, the smart devices can be equipped with antennas for wireless network communication. They can also include receiving and transmitting mechanisms capable of communicating with RFID / NFC tags, as well as software capable of establishing and managing communication with these tags. It is also understood that the smart devices can be equipped with short-range communication technologies such as RFID, NFC, Bluetooth, ANT, Zigbee, or similar.

[0011] The object of the present invention is to overcome the disadvantages of devices known from the prior art in this field. This object is achieved by a monitoring unit with the features of the independent claim. Preferred embodiments are the subject of the dependent claims.

[0012] According to the present invention, it comprises a unit for monitoring a drug delivery device. The monitoring unit preferably has a housing in which a monitoring circuit is arranged. The monitoring unit is capable of detecting and monitoring functions of the drug delivery device, which can be of a wide variety of types, such as the removal of protective caps, the insertion of an injection needle, the start and / or end of a dose delivery sequence, and the shielding of an injection needle after removal, to name just a few.

[0013] The monitoring unit is preferably equipped with a mounting mechanism featuring a mechanical interface, the mechanical interface being arranged to interact with a matching mechanical interface located on a drug delivery device, and with an activation switch positioned to activate the monitoring circuit. The arrangement with matching interfaces offers several advantages. One advantage is that a fixed connection can be established between the monitoring unit and the drug delivery device, while the monitoring unit can simultaneously be detached and used on other drug delivery devices. This allows the monitoring unit to be used with disposable drug delivery devices that are discarded after use.The monitoring unit is then detached and attached to a different drug delivery device. The matching mechanical interfaces can also be arranged and designed with specific and unique features that ensure only certain monitoring units are compatible with specific drug delivery devices. This can be important when a user has multiple treatment regimens with different drug delivery devices and medications, requiring specific monitoring units to be connected to specific drug delivery devices. If it were possible to connect a monitoring unit to any drug delivery device, there would be a high risk of obtaining unreliable data.

[0014] According to one possible solution, the drug delivery device can be equipped with an activator element that is operatively connected to a drive element of the drug delivery device. During the dose delivery sequence, the drive element pushes the activator element in a distal direction, acting on the activation switch. In this solution, the remaining force of the drive element is used to activate the monitoring unit. In this context, the activation switch can have at least one electrical switch that is operatively arranged to activate the monitoring circuit. Thus, closing the switch closes an electrical circuit to the monitoring circuit, thereby initiating the monitoring sequence.

[0015] There are several ways the activation switch can be designed to provide information about the status and operation of the drug delivery device. For example, the activation switch can be a vibration sensor positioned to detect vibrations generated during the operation of the drug delivery device. Vibrations can be generated by a number of components that move when the drug delivery device is used, such as when a piston rod has moved a stopper to the end of the injection or when the activator element is triggered.

[0016] Alternatively, the activation switch can also be a reed switch or a Hall effect switch. In this case, the activator element can be equipped with a magnet positioned so that it is detected by the reed switch or Hall effect switch when the drug delivery device is activated. The activator element and the switches are then arranged and oriented so that the magnet is positioned close to them when, for example, an injection sequence is completed. It is understood, however, that the magnet may come close to the switches during other sequences when the drug delivery device is activated.

[0017] Alternatively, the activation switch can be an opto-switch positioned so that a light beam is interrupted when the drug delivery device is activated. Again, the activator element and the switch are arranged so that the activator element is positioned near the switch during a specific sequence of drug delivery device use.

[0018] Other types of sensors can include capacitive proximity sensors or ultrasonic sensors. These types of sensors are capable of detecting the actual movement of an activator element during the operation of the drug delivery device. The sensors then do not need to be positioned as close to the activator element, which offers greater flexibility in the design of a monitoring unit.

[0019] The monitoring unit can be designed such that the activator unit can contain additional information derived from the activation switch. Such additional information could include, for example, the size of the medication container, the type of medication, or the strength of the medication. This information carrier could be a color, with the activation switch potentially incorporating an RGB color sensor and the activator element being marked with specific colors, each color corresponding to specific information regarding the medication to be dispensed.

[0020] Instead of a detectable color, other types of patterns can be used, such as barcodes or QR codes, where the activation switch can be a barcode reader or a QR reader and where the activator element is marked with a barcode or a QR code containing information about the drug to be dispensed.

[0021] Another alternative in this regard is the use of an RFID tag or an NFC tag, where the activation switch can be an RFID / NFC reader and the activator element is equipped with an RFID / NFC tag containing information about the medication to be dispensed.

[0022] To facilitate the connection between the monitoring unit and the drug delivery device, the mechanical interface can incorporate a number of flexible locking elements arranged to interact with corresponding locking elements on the drug delivery device. This solution ensures both a secure connection and a reliable release mechanism.

[0023] In this context, the flexible locking elements can have tongues equipped with ridges, the ridges being arranged to engage with ridges of the corresponding locking elements. To enhance the safety aspect regarding the connection of the correct monitoring unit with the correct drug delivery device, the mechanical interface can further include mechanical input elements featuring a special mechanical input design.

[0024] According to one solution in this regard, the mechanical input elements can have projections and recesses arranged in predefined patterns. The mechanical input elements can also have teeth. These projections and recesses can further be used by positioning the activation switch in the interface so that it is mechanically activated by the projections. The projections can then act directly on the activation switch to activate the monitoring unit, thus initiating the monitoring sequence.

[0025] Preferably, the activation switch is arranged so that it is activated during the operation of the drug delivery device, and even more preferably, the activation switch is arranged so that it is activated during a dose delivery sequence.

[0026] According to one possible solution, the drug delivery device can be equipped with an activator element that is operatively connected to a drive element of the drug delivery device, wherein the drive element pushes the activator element in a distal direction during the dose delivery sequence and acts on the activation switch. In this solution, the remaining force of the drive element is used to activate the monitoring unit.

[0027] According to a further embodiment of the invention, it can include a communication circuit that is operationally configured to transmit data to external data processing sources. Furthermore, the communication circuit is operationally configured to receive data from external data provisioning sources. In this solution, the monitoring unit is able to transmit monitoring data for further processing, for example, to monitor adherence to the treatment regimen. The physician can then receive information directly from the monitoring unit or via smart devices. The physician can then provide feedback or instructions to the user via the smart device or the monitoring unit.

[0028] In connection with the latter aspect, the monitoring unit may also include a user communication circuit that is operationally configured to transmit data to a user. The data transmitted to the user can thus be derived both directly from the monitoring function of the monitoring unit and from data transmitted to the monitoring unit from external sources.

[0029] These and other aspects and advantages of the present invention will become apparent from the following detailed description of the invention and from the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The following detailed description of the invention refers to the accompanying drawings. Fig. Figure 1 is an exploded view of a drug delivery device that can use a monitoring unit according to the present invention, Fig. Figures 2 to 8 are detailed views of components used in the drug delivery device according to Fig. 1 are included, Fig. Figure 9 shows a first embodiment of a monitoring unit according to the present invention, Fig. Figures 10 to 11 show detailed views of the monitoring unit of Fig. 9, Fig. Figure 12 shows a second embodiment of a monitoring unit according to the present invention, Fig. Figures 13 to 14 show detailed views of the monitoring unit of Fig. 12, Fig. Figures 15 to 18 show different functional views of the interaction between the monitoring units of Fig. 9 and Fig. 12 and the drug delivery device of Fig. 1, and Fig. Figures 19 to 26 show different types of monitoring and activation sensors that can be used in the monitoring unit. DETAILED DESCRIPTION OF THE INVENTION

[0031] The drawings show an example of a drug delivery device that can be used within the scope of the present invention. It has a generally tubular, elongated housing 10 with a distal end 12 and a proximal end 14. Fig. 1. The housing 10 is further provided with openings or windows 16 through which a generally tubular medication container 18 can be viewed. The medication container 18 is inserted into a medication container holder 20. Each window 16 is further provided with an inwardly directed, annular circumferential strip 22. As shown in Fig. As can be seen in Figure 3, a support wall 24 is attached to the circumferential strip 22, the support wall 24 being provided with a central passage 26. The edge of the central passage 26 and the inner edges of the circumferential strips 22 of the windows 16 form support surfaces for the medication container holder 20. The medication container 18 is provided with a movable stopper 28. The medication container 18 has a proximal end at which a medication dispensing element 30 is arranged. Fig. 2, which is either formed integrally with the drug container 18 or connectable to it. The drug delivery element 30 is preferably protected before use by a drug delivery element shield 32, which in the illustrated embodiment is a so-called rigid needle shield or RNS. However, it is understood that other types of drug delivery element shields can also be used to achieve the desired protection of the drug delivery element 30.

[0032] The proximal end of the housing is provided with a central passage 34, Fig. 1, through which a generally tubular drug delivery element guard 36 extends, Fig. 1. The drug delivery element guard 36 has a proximal tubular part 38 and two distally directed arms 40 extending from the tubular part 38. A drug delivery element guard spring 42, Fig. 2a is arranged between a distally directed circumferential wall portion of the drug delivery element guard 36 and a proximally directed surface of the support wall 24. The arms 40 are slidably arranged along the drug container holder 20. Inwardly directed projections 44 are arranged at the distal end of the arms 40. Fig. 1. The projections 44 are arranged so that they are operational with a tubular rotator 46, Fig. 4 and Fig. 5, a drive unit 48 interact.

[0033] The rotator 46 has a generally tubular shape and is provided with guide ribs 50 which are intended to interact with the projections 44 of the drug delivery element guard 36, as will be described below, with some sections 50 iThe guide webs are inclined with respect to the longitudinal axis L of the device. A proximal part of the rotator 46 is further provided with proximally directed tongues 52 adjacent to the guide webs, the free ends of the tongues 52 being provided with wedge-shaped, outwardly directed projections 54, the function of which is described below. The rotator 46 is further provided with ridges 55 on its inner surface at a distal end. Fig. 5, which provide a space 57 between the strips in a circumferential direction.

[0034] An actuating element 56, Fig. 4, is furthermore functionally arranged on the rotator 46. It has a first proximal tubular section 58 with a diameter slightly smaller than the inner diameter of the rotator 46. It also has a generally tubular second section 60, which is arranged to fit into and be attached to a distal part of the housing. The second section 60 is provided with two generally circular, radially extending wall sections 62a, 62b. Four longitudinally extending wall sections 64 are arranged around the circumference of the second section 60 and extend between the radially extending wall sections 62a, 62b. The most distal of the wall sections 62b is provided with radially outwardly directed projections 61 that fit into recesses 63 on a distal edge of the housing of the drug delivery device.Longitudinally extending strips 66 are arranged on two opposing longitudinal wall sections 64, which extend between the radial wall sections 62. The strips extend proximally with locking elements 67, which, in the illustrated embodiment, comprise tongue-shaped flexible sections 68 with a slightly outwardly inclined direction. The ends of the tongue-shaped sections 68 are each provided with an inwardly directed section 70. A proximally directed strip 72 is arranged on each inwardly directed section 70, the function of which is explained below. In a starting position of the locking elements 67 with respect to the rotator 46, the strips 72 fit into the spaces 57 between the strips 55 of the rotator 46, thereby providing a rotation lock for the rotator 46.

[0035] Furthermore, a release element 74 is located on the second section 60 of the actuating element 56. Fig. 4, arranged. The release element 74 has two elongated plate-like elements 76 connected to each other by a bridge 78. The bridge 78 has a central, longitudinally extending groove 80 that fits onto one of the longitudinally extending wall sections 64, with the plate-like elements 76 positioned radially outside the ribs 66. The release element 74 is then longitudinally displaceable so that the proximal ends of the plate-like elements 76 can act on the proximally directed tongue-shaped sections 68 of the locking element 67, as will be described below. The plate-like elements 76 are further provided with radially outwardly directed projections 82, the projections 82 being arranged to fit into slots 84 in the housing 10 at its distal end. Fig. 1.

[0036] The first section 58 is further provided with proximally extending arms 86, which are flexibly arranged in a generally radial direction. The free ends of the arms 86 have outwardly extending projections 88, which are intended to interact with inner surfaces of the rotator 46, as will be described below. Furthermore, the free ends of the arms 86 are provided with inwardly extending projections 90, wherein the projections 90 are intended to interact with recesses 92 on a generally elongated piston rod 94. Fig. 6. The projections 90 extend into a central passage 96 of the actuating element 56, with the piston rod 94 fitting into the passage 96.

[0037] The drive unit 48 also has a drive spring 98, Fig. 6, which in the illustrated embodiment is placed within a cavity of the hollow piston rod 94, wherein the drive spring 98 is positioned with its proximal end in contact with an end wall 100 of the piston rod 94, Fig. 2. A guide rod 102 is arranged inside the drive spring 98. The distal end of the drive spring 98 is in contact with a generally U-shaped element, hereinafter referred to as the activator 104, which has a base 106 and two arms 108. Fig. 6. The arms 108 of the activator 104 are aligned in a proximal direction along the outer surface of the piston rod 94 and in contact with it, the free ends of the arms 108 being provided with generally radially outwardly directed ribs 110. These ribs 110 are arranged such that they are in contact with a proximally directed surface 112. Fig. 4, which surrounds the central passage 96 of the actuating element 56.

[0038] The activator 104 also includes an activator element 114, Fig. 6 and Fig. 7, which is arranged in a distal end wall 116 of the housing 10 of the drug delivery device. In the embodiment shown, the activator element 114 has a generally disc-shaped body 118, which is arranged to fit into a cylindrical, central passage 120 in the end wall 116. The central passage 120 is provided with a wall section 122, which has a generally rectangular opening 124. The proximally directed surface of the disc-shaped body 118 is provided with two proximally directed tongues 126, which are somewhat flexible in the radial direction. The tongues 126 are arranged to extend through the rectangular opening 124. The free ends of the tongues 126 are provided with outwardly directed ridges 128. Furthermore, the outer surfaces of the tongues 126 are provided with transverse ribs 130.In a starting position, the webs 130 are adjacent to the inner edge of the central passage 120, and the proximal ends of the tongues are in contact with the base 106 of the activator 104, as in . Fig. Figure 8a shows that the distally directed surface of the disc-shaped body 118 is provided with a central projection 132. Furthermore, the distally directed surface of the end wall 116 is provided with a number of concentric rings 134 and grooves 136, as shown in Figure 8a. Fig. 7 can be seen.

[0039] The drug delivery device is further equipped with a drug delivery element shield remover 138, Fig. 1. It has a generally tubular handle 140 with an end wall 142. The distally directed surface of the end wall 142 is provided with a seat in which a generally tubular handle element 144 is placed. The handle element 144 is coaxial with the drug delivery shield 32 and surrounds it when the drug delivery shield remover 138 is attached to the proximal end of the drug delivery device. The handle element 144 has a number of generally proximally directed, slightly inwardly inclined tongues 146 that engage with the outer surface of the drug delivery shield 32.

[0040] According to the present invention, a monitoring unit 200, Fig. 9 and Fig. 11, arranged so that it is operationally connected to a drug delivery device as described above. The monitoring unit 200 has a housing 202 which may, although not required, have a shape and appearance corresponding to the drug delivery device to which it is to be connected. The housing 202 has a proximally directed fastening mechanism 204 which is designed to interact with a distal end of the drug delivery device. In the embodiment shown, the fastening mechanism 204 has a central passage 206 which is shaped and dimensioned to fit onto the distal end of the drug delivery device.

[0041] To enable the connection to be detachable, the fastening end of the monitoring unit 200 is provided with a fastening mechanism which has locking elements in the form of a number of fastening tongues 208, Fig. 10, which are generally flexible in the radial direction. The free ends of the fastening tongues 208 are provided with inwardly directed strips 210, which are connected to corresponding locking elements in the form of an annular strip 212, Fig. 7, at the distal end of the housing of the drug delivery device, the retaining tongues 208 are to interact. The retaining tongues 208 are attached to an annular element 214, the annular element 214 being provided with two opposing, distally oriented tongues 216. The free ends of the tongues 216 are provided with outwardly directed ridges 218, the ridges being arranged to fit into recesses 220 in a tubular retaining element 222. The retaining element 222 is provided at its proximal end with a plate-shaped contact element 224, where the retaining element 222 and the contact element 224 are connected to each other by a number of bridges 226. The bridges 226 are arranged slightly radially inward with respect to the retaining element 222, so that an annular recess 228 is formed. Furthermore, the free ends of the fastening tongues 208 are arranged in the spaces between the bridges 226.The fastening tongues 208 and the bridges 226 are designed and positioned such that the outer surfaces of the tongues 208 are positioned slightly radially outside the bridges 226. Furthermore, a wire spring 230 is arranged in the annular recess 228, which is in contact with the outer surface of the fastening tongues 208 and generates an elastic force in a radial outward direction.

[0042] A mechanical interface 231 is arranged on the monitoring unit 200. The mechanical interface can have a number of rings 232 and grooves 234 on the proximally oriented surface of the contact element 224, which are designed to mate with the rings 134 and grooves 136 of the end surface of the drug delivery device and form a contact interface. Furthermore, the contact element is preferably provided with a number of passages 236, with switches 238 arranged in the passages 236. The switches are functionally connected to electrical switching elements 240. Fig. 11, which enable activation of the monitoring unit, as will be described below. Preferably, the switches 238 are arranged and designed to interact with contact surfaces on the drug delivery device, such that the switches are activated when the monitoring unit is attached to the drug delivery device. Preferably, the positions of the switches 238 of the electrical switching elements are arranged in a specific pattern, which may be specific to a particular monitoring unit, and wherein a particular drug delivery device is provided with contact surfaces that have the same design, such that all switches are activated when the monitoring unit is attached to the drug delivery device. In this way, there is an additional input requirement that must be met to activate the monitoring unit.The contact surfaces are, for example, the rings and grooves in which the switches are arranged at different intervals in a radial direction, as in . Fig. Figure 9 shows the advantage of the rings: the angular position between the monitoring unit and the drug delivery device is irrelevant when the two are connected. As shown in Fig. As can be seen in Figure 9, the switches 238 are placed in the grooves 234, making it difficult to manipulate the switches 238 with the fingers, which provides increased security against improper use of the monitoring unit 200.

[0043] To activate the monitoring unit at a specific point in the operation of the drug delivery device, such as at the end of a dose delivery sequence, the monitoring unit can also be equipped with an activation switch 242. In the Fig. In the embodiment shown in Figure 9, this activation switch 242 can be arranged in a central position of the interface of the monitoring unit. The activator of the drug delivery device is then used to activate the monitoring unit, as will be described below.

[0044] The interface between the drug delivery device and the monitoring unit can further feature mechanical patterns designed to interact with each other. For example, the proximal surface of the contact element 224 can have a number of teeth 244, for instance, around a circumference. These teeth 244 are arranged to interact with corresponding teeth 246 at the distal end of the drug delivery device, with the number, shape, and position of the teeth being chosen to achieve an input function. Thus, only monitoring units 200 and drug delivery devices exhibiting the same pattern can be connected. This allows the monitoring unit 200 and the drug delivery device to be adapted so that only specific connections are possible.

[0045] Fig. Figure 12 shows another connection and interface solution. Here, a proximal end of a housing 300 for a monitoring unit 302 is provided with a fastening mechanism having locking elements in the form of a number of longitudinal slots 304, forming a number of tongues 306 between the slots 304, the tongues 306 being flexible in the generally radial direction. Furthermore, an annular groove 308 is arranged on the outer surface of the tongues 306. A wire spring 310 is arranged in the groove 308, limiting the bending movement of the tongues 306. The tongues 306 are also provided with inwardly directed ribs 312. The inner surface of the free ends of the tongues 306 and the inwardly directed ribs 312 have a cross-sectional view showing a first proximally directed inclined surface 3141. Fig. 13, a second generally flat surface 3142 running parallel to the tongue 306, and a third distally directed inclined surface 3143.

[0046] The interface of the drug delivery device is provided with corresponding locking elements in the form of an annular strip 316. The strip 316 is provided with a fourth distally inclined surface 3144, which preferably has a slight inclination in the range of 5–15 degrees in the longitudinal direction, in order to interact with the surface 3141. A fifth, generally flat surface 3145, which runs parallel to the longitudinal direction, is connected to the fourth distally inclined surface 3144. The fifth flat surface 3145 is arranged such that it interacts with and is in contact with the second flat surface 3142 of the monitoring unit, as shown in Fig. Figure 14 shows that the flat fifth surface 3145 transitions into a sixth, proximally directed, inclined surface 3146. The sixth surface 3146 has a steeper inclination, which can be in the range of 30–60 degrees. The sixth surface 3146 is arranged so that it is in contact with and interacts with the third surface 3143 of the monitoring unit, see Figure 14. Fig. 14.

[0047] The inclination of the fourth surface 3144 is chosen such that the force required to attach the monitoring unit 302 to the drug delivery device is relatively low; that is, the tongues can bend relatively easily when they come into contact with the rim of the drug delivery device. Furthermore, the inclinations of the third surface 3143 and the sixth surface 3146 are chosen such that a relatively strong holding force is generated when the monitoring unit is attached to the drug delivery device. Additionally, the engagement length of the contact surfaces of the monitoring unit and the drug delivery device is chosen to be rather short. This choice is made to facilitate the attachment of the monitoring unit and to increase the bending force required to release the connection.A mechanical interface 318 of the second embodiment is provided with a centrally located activation switch 320 and three switches 322, which can be activated in various combinations to provide different information when the monitoring unit is activated. Different combinations can, for example, indicate different strengths of the active ingredient in the medication container used. The mechanical interface 318 also has ring-shaped teeth 324, which are arranged to interact with ring-shaped teeth of the same mechanical design at a distal end of a medication delivery device as described above.

[0048] Although the mechanical interface has been described with ring-shaped teeth, ring-shaped projections, and ring-shaped grooves, the person skilled in the art can easily design other mechanical configurations that offer a unique input function.

[0049] The device is intended to function as follows. When the medication dispensing device is issued to a user, a medication container 18 with an attached medication dispensing element shield 32 is placed in the medication container holder 20, and a medication dispensing element shield remover 138 is attached to the proximal end of the medication dispensing device. The actuating spring 98 is tensioned by pushing the piston rod 94 distally relative to the actuating element 56, so that the inwardly directed projections 90 of the arms 86 of the actuating element 56 engage in the recesses 92 of the piston rod 94 and thereby hold the spring-tensioned piston rod 94.

[0050] If a drug delivery device is to be used, a monitoring unit 200, 302 must be attached. The monitoring unit is slid onto the distal end of the drug delivery device, with a proximal surface of the monitoring unit coming into contact with a distal surface of the projections 82 of the triggering element 74. By further sliding the monitoring unit 200, 302 relative to the drug delivery device, the triggering element 74 with its plate-like elements 76 is moved in the proximal direction. The proximal ends of the plate-like elements 76 then act on the tongue-shaped sections 68, causing the tongue-shaped sections 68 to move radially inward, thereby disengaging the ridges 72 from the space 55 of the rotator 46. Fig. 15, which allows the rotator 46 to rotate freely, as will be described below. When the monitoring unit is attached to the drug delivery device, the interfaces of the two are matched, provided the correct monitoring unit is used for the intended drug delivery device. Some of the switches are then activated by the interface, making the monitoring unit ready for activation and the execution of functions, as will be described below.

[0051] When a dose of medication is to be dispensed, the medication delivery element shield remover 138 is removed from the proximal end of the medication delivery device by being pulled proximally. Due to the engagement of the tongues 146 with the medication delivery element shield 32, the medication delivery element shield 32 is also pulled proximally and removed from the medication delivery element 30. The proximal end of the medication delivery device is then pressed against a dose delivery site. This causes the medication delivery element shield 36 to move within the housing 10 and relative to it. This, in turn, causes the projections 44 of the medication delivery element shield 36 to move along the guide ribs 50 of the rotator 38, so that the projections align with the inclined guide rib 50. icome into contact, which causes the rotator 46 to rotate around the longitudinal axis L of the device.

[0052] Therefore, if, as described above, the monitoring unit 200, 302 has not been installed beforehand, the rotator will be prevented from rotating, and consequently it is impossible to use the device.

[0053] The rotation of the rotator 46 moves the outwardly directed projections 88 of the actuating element 56 out of contact with the inner surfaces of the rotator 46. The arms 86 of the actuating element 56 can now bend freely outwards, thereby moving the inwardly directed projections 90 of the arms 86 out of contact with the recesses 92 of the piston rod 94.

[0054] The piston rod 94 can now move freely in a proximal direction due to the force of the drive spring 98, with the proximal end of the piston rod 94 acting on the plug 28 inside the drug container 18 and moving it in a proximal direction, so that a dose of the drug is ejected through the drug delivery element 30. Fig. 16.

[0055] When the plug 28 has been moved by the piston rod 94 almost to its proximal end inside the drug container 18, the piston rod 94 is moved out of contact with the arms 108 of the activator 104. The arms 108 of the activator 104 are thus free to bend inwards, so that the ribs 110 are moved out of contact with the surfaces 112 of the actuating element 56, and due to the force of the drive spring 98, which is in contact with and acts on the base 106 of the activator 104, the activator 104 is moved distally. Due to the contact with the activator element 114, the activator element 114 is also moved distally in the central passage 120, so that the central projection 132 protrudes from the central passage 120 and acts on the activation switch 242 of the monitoring unit. Fig. 17, which activates the monitoring unit 200, as described below. The movement of the activator element 114 is stopped when the outwardly directed ridges 128 encounter a proximally directed surface of the end wall 116 of the drug delivery device. This sudden stop also provides an audible and tactile signal that the dose delivery sequence is complete and that the drug delivery device can be safely removed.

[0056] Once the dose has been delivered, the drug delivery device is removed from the position. This, in turn, causes the drug delivery element guard 36 to move proximally by the drug delivery element shielding spring 42 to extend through the proximal end of the drug delivery device and cover the drug delivery element 30. As the rotator 46 has rotated, the projections 44 of the drug delivery element guard 36 slide over the wedge-shaped projections 54 of the tongues 52 of the rotator 46 and are positioned proximal to them, thereby locking the drug delivery element guard 36 in the extended, covering position. Fig. 18. The device can now be disposed of safely.

[0057] The monitoring unit 200, 302 is equipped with a number of functions and features that can be activated when the activation switch 242 is actuated as described above. A key feature is a monitoring circuit comprising an electronic circuit 400 with a processor 402. Fig. 10, which is capable of processing data program code to perform various tasks. The data program code is preferably stored in suitable memory elements 404, in which queried data can also be stored, as will be described below. The electronic circuit 400 is further equipped with a power supply 406, such as button cells, photovoltaic panels, etc. Furthermore, the switching elements 240, 242 mentioned above are electronically connected to the electronic circuit 400. In this context, it may be necessary to actuate all switches simultaneously to activate the monitoring unit. The electronic circuit can also be equipped with a user communication circuit 408, which is designed and programmed for communication with a user. The user communication circuit 408 can have display elements that can communicate visually, e.g.by text stored in the electronic module, which is displayed on a suitable display 410 on the monitoring unit. The display may be protected by a suitable transparent cover or glass 411. Additionally or instead, the user communication circuit may include audio elements 412 that can communicate acoustically, e.g., by means of a recorded message stored in the electronic module and played back via a suitable loudspeaker of the electronic module or of the device itself.

[0058] A further development of the activation function involves equipping the monitoring unit 200, 302 with at least one communication circuit 414. The communication technologies that the communication circuit 414 can utilize can include short-range communication technologies such as RFID, NFC, or similar technologies, as well as Bluetooth, ANT, and ZigBee, to name just a few. This type of wireless communication technology can also be used to activate the monitoring unit. The communication circuit can be used to monitor the use of the medication delivery device, allowing information to be transmitted from the medication delivery device to the monitoring unit.

[0059] According to one possible feature, if the monitoring unit 200, 302 is equipped with communication circuits, the monitoring data acquired by the monitoring unit can be transferred to external storage sources and / or external devices. For example, if NFC technology is used, a mobile NFC-enabled device can retrieve the monitoring data from the usage management module. The same functionality can also be provided when using Bluetooth communication technologies.

[0060] The mobile device can then either be able to process the data, such as calculating the time and date of an event of the drug delivery device, or can in turn transmit the monitoring data to external databases via the communication technologies of the mobile device, such as cellular radio communication networks, e.g. GSM, 3G, 4G, etc., and / or wireless local area networks, whereby the networks can provide access to the Internet and thus to a large number of external data storage sources, data processing centers, etc.

[0061] Regarding communication technologies, it is of course possible to integrate the aforementioned communication technologies into the monitoring unit 200, 302 as such. The monitoring unit can then communicate directly with external data storage sources, data processing centers, etc., via communication networks. The monitoring data can preferably be made available to a physician or similar professional responsible for the treatment of the user of the medication delivery device, who may have established a treatment plan. This retrieved monitoring data can then be analyzed to derive information such as adherence, the lack of which may lead to intervention by the physician.

[0062] The 400 electronic circuit can also be equipped with a tracking function that determines the user's geographic location and can be used for various purposes. This tracking can be achieved through different mechanisms. The electronic circuit can be equipped with a GPS module, which records the user's current position at the time of dose delivery using GPS coordinates. Alternatively, the GSM function can be used for location determination. The GPS and GSM functions can also be combined with a Wi-Fi tracking function to improve indoor location accuracy.

[0063] Regarding the activation of the monitoring unit, the electronic circuit can preferably be equipped with a suitable shutdown function, such as a timer function that cuts off the power supply to the circuits after a specific period, for example, after the medication delivery has been completed. This extends the lifespan of the power source, as it is inactive when no action is taking place. Furthermore, the electronic circuit can be equipped with a delay function that, for example, delays the transmission of certain information. This can be used if the monitoring unit is activated during a dose delivery sequence, but not at the end. The signal indicating that the dose has been delivered can then be delayed to ensure that the entire dose has been administered. This signal could, for example, be an audible signal from the monitoring unit that can be heard by the user.With this delay function, the timing of the activation of the monitoring unit is not so crucial.

[0064] Since the monitoring unit is detachable from the drug delivery device, it can be used with both disposable and reusable drug delivery devices, and since it can be used many times with many devices and / or in many dose administration procedures, it does not substantially increase the overall cost of a drug treatment regimen.

[0065] Although the activation of the monitoring unit has been described in relation to the end of dose delivery, the monitoring unit can be activated by a number of different features, functions, and processes, such as the removal of protective caps, the insertion of an injection needle, the beginning and / or end of a dose delivery sequence, and the shielding of an injection needle after withdrawal. A person skilled in the art involved in the design of drug delivery devices will have no difficulty in identifying suitable events during the operation of such a device if an activation function can be added.

[0066] Within the scope of the present invention, the monitoring unit can be activated in various ways that are not purely mechanical. Fig. Figures 19-26 show a number of different conceivable solutions in which the end of dose delivery is signaled and the monitoring unit is activated. Fig. Figure 19 shows a shock or vibration sensor 500 positioned near the activator element 114. For example, when the monitoring unit 200 is connected to the drug delivery device, the switches 238 of the monitoring unit 200 are triggered as described above, waking up the electronic circuit with the processor, which in turn powers and monitors the vibration sensor 500. The shock or vibration sensor 500 can detect the vibration generated when an injection is initiated, which is recorded by the sensor 500 via the housing of the drug delivery device and the connection to the monitoring unit 200. At the end of the injection, the final click, generated by the drive spring as described above, is then registered by the shock sensor 500.The vibration can be caused by the activator element hitting the shock sensor directly, or by the activator element hitting the housing of the monitoring unit, or by the activator hitting the end wall.

[0067] Fig. 20 and Fig. Figure 21 shows an alternative solution in which a reed switch 502 can be used. A reed switch 502 is connected to the circuit board 400 near the activator element 500. The activator element 114 is then equipped with a magnet 504. Fig. 21. Before the end of the injection, the activator element 114 with its magnet 504 is positioned so that there is a distance to the reed switch 502, thus putting the reed switch in its off state. At the end of the injection, the activator element 114 is moved distally as described above, bringing its magnet 504 closer to the reed switch, thereby switching the reed switch to its on state.

[0068] Another practical solution is in Fig. 22 and Fig. Figure 23 illustrates the use of an opto- or photointerrupt sensor 506. It generally has a U-shape with a light source on one arm and a light detector on the other, facing each other. The light source can be an LED and the light detector a photodiode. When the monitoring unit is activated upon connection to the drug delivery device, the light source emits a light beam 508, which is detected by the light detector. The photointerrupt sensor 506 can be positioned near the activator element 114 such that, at the end of the injection, a distal end of the activator element 114 moves into the U-shape of the photointerrupt sensor 506, thereby refracting or interrupting the light beam 508 between the light source and the light detector. This interruption is detected by the electronics and indicates the end of the injection.

[0069] Regarding the use of light, a light source 510, such as an LED, can be positioned adjacent to the distal end of the activator element. Fig. 24. Furthermore, an optical sensor 512 is arranged such that light emitted by the light source 510 and reflected from a distally directed surface of the activator element 114 is detected by the optical sensor 512. When the activator element 114 is moved distally by the activator at the end of an injection sequence, the reduced distance between the activator element 114 and the optical sensor 512 is detected, thereby activating the monitoring unit 200.

[0070] A number of other types of sensors 514 can be used to detect the movement of the activator element, as in Fig. Figure 25 shows that one type of sensor 514 can be a capacitive proximity sensor. This sensor 514 is also placed adjacent to the distal end of the activator element so that the proximity sensor can detect the movement of the activator element 114 as it moves at the end of the injection.

[0071] Another type of sensor 514 is an ultrasonic sensor that can be positioned near the activator element 114. The ultrasonic sensor is able to detect the displacement of the activator element 114 during the end of the injection sequence.

[0072] Another sensor type is a Hall effect sensor, which is positioned adjacent to the activator element 114, wherein the activator element is provided with a magnet 504, so that when the activator element moves in the distal direction, it enters the area of ​​the Hall effect sensor, the Hall effect sensor detecting the magnet of the activator element and thereby activating the monitoring unit 200.

[0073] The activator element can also be used to transmit data from the drug delivery device to the monitoring unit. Data that can be transmitted includes the type of drug and / or the amount of drug administered. For this purpose, the activator element is provided with information that can be derived by the monitoring unit. In this context, the activator element can be colored, with each color representing specific information. The monitoring unit is then equipped with a sensor 514 capable of detecting specific colors, such as an RGB sensor, and positioned to detect the color on the activator element 114. For example, the color red can be associated with information stored in the monitoring unit about a specific dose size.When the monitoring unit is connected to the medication delivery device, the RGB sensor can detect the red color and activate the monitoring unit 200 to indicate that it is connected to a medication delivery device that has a medication container with a specific dose size.

[0074] Instead of color, other types of information carriers can also be used, e.g., a barcode with specific information. In this solution, sensor 514 is a barcode reader positioned adjacent to activator element 114. The activator element is thus equipped with a barcode 516. Fig. 26a, provided on its distally directed surface so that it is readable by the barcode reader. Alternatively to the barcode, a QR code 518 can be provided at the distal end of the activator element 114, Fig. 26b, where the sensor 514 is a QR code reader 530. Both the barcode 516 and the QR code 518 can contain further information that can be obtained by the monitoring unit 200. Another solution can include an RFID chip 520, Fig. 26c, which is attached to or embedded in the activator element. The sensor 514 of the monitoring unit can then be an RFID reader placed near the activator element, the RFID reader being able to retrieve data stored in the RFID chip 520. The RFID chip 520 can contain various pieces of information that can be retrieved by the monitoring unit.

[0075] It is understood that the embodiments described above and shown in the drawings are to be regarded only as non-limiting examples of the invention and that they can be modified in many respects within the scope of the claims. QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] WO 2014 / 128156

[0003] WO 2014 / 020008

[0006]

Claims

[1] Monitoring unit (200, 302) for a drug delivery device, the monitoring unit comprising: - a housing (202, 300), - a monitoring circuit (400) arranged in the housing (202, 300) and capable of detecting and monitoring functions of the medication delivery device when the medication delivery device is in use, - a fastening mechanism provided with releasable locking elements (208, 306) for releasable attachment to the medication delivery device, the fastening mechanism comprising a number of flexible locking elements (208, 306) arranged to cooperate with matching locking elements on the medication delivery device, - a mechanical interface (231, 318) arranged to cooperate with a matching mechanical interface arranged on a drug delivery device, and - an activation switch (242, 320) arranged in the mechanical interface and arranged to activate the monitoring circuit (400), wherein the medication delivery device is provided with an activator element (114) arranged in the mechanical interface and operatively connected to a drive element (98, 104) of the medication delivery device, wherein, when the medication delivery device is in use, the drive element (98, 104) urges the activator element (114) in a distal direction during the dose delivery sequence, thereby acting on the activation switch (242, 320). [2] The monitoring unit of claim 1, wherein the activation switch comprises at least one electrical switch operatively arranged to activate the monitoring circuit. [3] The monitoring unit of claim 1, wherein the activation switch is a vibration sensor (500) arranged to detect vibrations generated when the medication delivery device is operated. [4] A monitoring unit according to claim 1, wherein the activation switch is a reed switch (502) or a Hall switch (514) and wherein the activator element (114) is provided with a magnet (504) arranged to be detected by the reed switch or the Hall switch when the medication delivery device is operated. [5] A monitoring unit according to claim 1, wherein the activation switch is an opto-switch arranged to interrupt a light beam when the medication delivery device is operated. [6] The monitoring unit of claim 1, wherein the activation switch is a capacitive proximity sensor or an ultrasonic sensor positioned with respect to the activator element to detect movement of the activator element during operation of the medication delivery device. [7] Monitoring unit according to claim 1, wherein the activator unit comprises further information that can be derived from the activation switch. [8] Monitoring unit according to claim 7, wherein the activation switch comprises an RGB color sensor and wherein the activator element is provided with certain specific colors, wherein a specific color is associated with certain information regarding the drug to be dispensed. [9] Monitoring unit according to claim 1, wherein the activation switch is a barcode reader or a QR reader and wherein the activator element is provided with a barcode or a QR code containing information regarding the drug to be dispensed. [10] Monitoring unit according to claim 1, wherein the activation switch is an RFID / NFC reader and wherein the activator element is provided with an RFID / NFC tag containing information regarding the drug to be dispensed. [11] A monitoring unit according to any one of the preceding claims, further comprising a communication circuit (414) operatively arranged to transmit data to external data processing sources. [12] A monitoring unit according to claim 11, wherein the communication circuit (414) is operatively arranged to receive data from external data providing sources. [13] A monitoring unit according to any preceding claim, further comprising a user communication circuit (408) operatively arranged to communicate data with a user.

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