JP2021072898A - Pen type injection device, and electronic clip type module for the same - Google Patents

Abstract

To provide an auxiliary device for attachment to an injection device.SOLUTION: An electronic clip type module (2) for attachment to a pen type injection device (1) comprises positioning arrangement for ensuring a predetermined positional relationship between a module and the injection device, and fixing arrangement for fixing the module to the injection device.SELECTED DRAWING: Figure 2b

Description

The present invention relates to an auxiliary device for attachment to an injection device.

There are various diseases that require regular treatment by injection of drugs. Such injections can be made using injection devices used by healthcare professionals or the patients themselves. As an example, type 1 and type 2 diabetes can be treated by the patient himself, for example, by injecting insulin doses once or multiple times daily. For example, a pre-filled disposable insulin pen can be used as an injection device. Alternatively, a reusable pen may be used. A reusable pen allows you to replace an empty drug cartridge with a new one. Each pen can include a set of disposable needles that are replaced before each use. The insulin dose to be injected can then be manually selected with the insulin pen, for example by turning the dose knob and viewing the actual dose from the insulin pen dose window or display. The dose is then injected by inserting the needle into the appropriate skin area and pressing the injection button on the insulin pen. Information about the type and dose of insulin injected, for example, to monitor insulin injections, for example, to prevent mishandling of insulin pens, or to be able to record the doses already administered. It is desirable to measure information about the condition and / or use of the injectable device, such as. In this regard, Patent Document 1 discloses a medical device including a value sensor. The radio frequency identification (RFID) unit includes a value sensor, such as a pressure sensor, and is integrated with the liquid drug container to allow wireless monitoring of pressure or other drug-related parameter values. The liquid drug container is connected to a first housing member of the medical device, which can constitute, for example, a pre-filled disposable injection device. The RFID unit wirelessly communicates with a control circuit contained within the second housing member of the medical device, which is releasably attached to the first housing member. The control circuit processes the value measured by the RFID unit, compares the value with a predetermined value, warns the user if the measured value deviates from the normal operating state, and for further data processing. , Adapted to communicate data related to measurements to external devices.

Therefore, the control circuit of the medical device described in Patent Document 1 can be used together with a series of filled disposable injection devices, but an RFID unit provided with a value sensor needs to be included in the drug container of the filled disposable injection device. The presence significantly increases the cost of pre-filled disposable injection devices.

For example, Patent Document 2 describes providing an auxiliary device provided with a fitting unit for releasably attaching the device to an injection device. The device is equipped with a camera and is configured to determine the dose of drug dialed to the injection device by performing Optical Character Recognition (OCR) on a captured image that can be seen through the dose window of the injection pen. Will be done.

WO2009 / 024562 WO2011 / 117212

According to the first aspect of the present invention, it is an auxiliary device for attachment to an injection device:
With alignment to ensure a given positional relationship between the auxiliary device and the injection device;
Auxiliary devices are provided that include a fixed arrangement for fixing the auxiliary device to the injection device.

The aligned arrangement and the fixed arrangement may be separate arrangements.

The alignment arrangement may include a positioning channel within the body of the auxiliary device and the positioning channel may be configured to fit into a positioning rib on the injection device. Here, the positioning channel may be located at one end of the main body of the auxiliary device.

The alignment arrangement can include first and second protrusions located on each of the first and second support members, the auxiliary device having the protrusions in the recess of the injection device when there is a predetermined positional relationship. It can be configured to engage. Here, the auxiliary device has a body that defines the injection device receiving channel, and one protrusion may be located on each side of the injection device receiving channel, or the support members may be urged toward each other. Good. Here, the protrusions can have sloping sides, and the slope of the side of each protrusion closest to the bottom of the injection device receiving channel is greater than the slope of the side of the protrusion farthest from the bottom of the injection device receiving channel. You may.

When the auxiliary device can be provided with an optical reading arrangement and there is a predetermined positional relationship between the auxiliary device and the injection device, the optical reading arrangement is directed to the display of the injection device and at least partially covers the display. Can be done.

The auxiliary device can have a body that defines the injection device receiving channel, and the fixed arrangement can include a closure that is removable and attachable across the injection device receiving channel.

The fixed arrangement may be movably attached to the body on the first side of the injection device receiving channel. Here, the fixed arrangement may be hinged to the body on the first side of the injection device receiving channel.

The fixed arrangement may be detachably connected to the body of the auxiliary device by a latch and catch arrangement on the second side of the injection device receiving channel.

The alignment and fixation arrangements can include members that contribute to aligning and fixing the auxiliary device onto the injection device.

The alignment arrangement can include at least one protrusion, and the auxiliary device can be configured such that at least one protrusion engages the recess of the injection device when there is a predetermined positional relationship. At least one protrusion may be located on the support member.

In one embodiment, the alignment arrangement can include first and second protrusions, the first and second protrusions in the respective recesses of the injection device when the auxiliary device has a predetermined positional relationship. It can be configured to engage. The first and second protrusions may be located on the first and second support members, respectively.

The first and second support members can be urged towards each other. In addition, the first and second support members can be releasably pushed towards each other, for example by a closure. When there is such a fixing force, the auxiliary device is fixed to the injection device. The auxiliary device can then remain attached to the injection device due to the urging force of the support member.

The fixed arrangement can include at least one protrusion, and the auxiliary device can be configured such that at least one protrusion engages the recess of the injection device when there is a predetermined positional relationship. At least one protrusion may be located on the closure or hinged fixation arrangement.

The fixed arrangement can include at least one flexible support member and / or at least one hinged fixed arrangement. For example, the auxiliary device can include two flexible support members and a hinged closure.

A second aspect of the present invention provides a system comprising the auxiliary device and an injection device.

The auxiliary device may be positioned so as not to prevent the user from approaching the dose knob or injection button of the injection device when there is a predetermined positional relationship between the auxiliary device and the injection device.

The auxiliary device may be positioned so as not to completely cover the drug information label provided on the injection device when there is a predetermined positional relationship between the auxiliary device and the injection device.

The auxiliary device may be positioned so as to at least partially cover the dose window or display of the injection device when there is a predetermined positional relationship between the auxiliary device and the injection device.

The injection device can include at least one protrusion that interacts with the alignment of the auxiliary device. At least one protrusion may include a positioning rib.

The injection device can include at least one recess that interacts with the alignment of the auxiliary device.

The injection device can include positioning ribs and two recesses that engage with each of the positioning channels and protrusions of the auxiliary device.

A third aspect of the invention is at least the injection device for aligning and / or immobilizing the auxiliary device on the injection device by interacting with the alignment and / or fixation arrangement of the auxiliary device. The use of one protrusion and / or at least one recess is provided. At least one protrusion and / or at least one recess of the injection device to align or secure the auxiliary device onto the injection device by interacting with the alignment and / or fixation of the auxiliary device. Can be used. At least one protrusion and / or at least one recess of the injection device to align and secure the auxiliary device onto the injection device by interacting with the alignment and / or fixation arrangement of the auxiliary device. Can be used.

The protrusion of the injection device may be a positioning rib that interacts with the positioning channel of the auxiliary device. However, the protrusion of the injection device can be of any shape suitable for interacting with the positioning channel of the auxiliary device. The protrusions can include, for example, structures such as points (pips), protrusions, ridges and the like.

The injection device can include two recesses that interact with the two protrusions of the auxiliary device. The recess can be, for example, a hole, a recess, an elongated hole, a groove, or a step.

Hereinafter, embodiments of the present invention will be described only as an example with reference to the accompanying drawings.

Exploded view of the injection device; FIG. 3 is a detailed perspective view of a part of the injection device of FIG. 1a. FIG. 5 is a schematic view of an auxiliary device releasably attached to the injection device of FIG. 1a according to an embodiment of the present invention. FIG. 3 is a perspective view of an auxiliary device releasably attached to the injection device of FIG. 1a according to various embodiments of the present invention. FIG. 5 is a perspective view of an auxiliary device releasably attached to the injection device of FIG. 1a according to another embodiment of the present invention. It is a figure which shows the possible functional distribution among devices when a and b auxiliary devices (such as auxiliary devices of FIGS. 2a and 2b) are used together with an injection device. It is the schematic of the auxiliary device of FIG. 2a attached to the injection device of FIG. 1a. It is a flowchart of the method used in various embodiments. It is a flowchart of a further method used in various embodiments. It is a flowchart of a further method used in various embodiments. It is a schematic diagram of the tangible storage medium 60 according to the embodiment of the present invention. It is an information sequence chart which shows the flow of information between various devices by embodiment of this invention. It is a side view of the auxiliary device of FIG. 2b attached to the injection pen of FIG. 1a (shown by two sheets of FIGS. 8a and 8b). FIG. 2 is a side view of the auxiliary device in a view similar to FIG. 8 with the injection pen omitted and the closure open (shown in two sheets, FIGS. 9a and 9b). FIG. 8 is a cross-sectional view of the arrangement of the auxiliary device and the injection pen of FIG. 8 before the auxiliary device engages the injection device. a is a partially cutaway perspective view of the details of FIG. b is a partially cutaway perspective view of another detail of FIG. FIG. 10 is a cross-sectional view similar to FIG. 10 in which the auxiliary device is fitted to the injection device. It is a cross-sectional view of the auxiliary device of FIG. 2b at a position further along the device of the cross section shown in FIG. FIG. 13 is a cross-sectional view similar to FIG. 13 in which the auxiliary device is placed on the injection pen and fastened in place.

Hereinafter, embodiments of the present invention will be described with respect to the insulin injection device. However, the invention is not limited to such applications and can be equally well placed with injection devices that release other agents, or other types of medical devices.

FIG. 1a is an exploded view of the injection device 1 and may represent, for example, Sanofi's Solostar® insulin injection pen.

The injection device 1 of FIG. 1a is a pre-filled disposable injection pen comprising a housing 10 and an insulin container 14 to which a needle 15 can be attached. The needle is protected by the inner needle cap 16 and the outer needle cap 17, and the outer needle cap 17 may be covered by the cap 18. The insulin dose released from the injection device 1 can be selected by turning the dose knob 12, after which the selected dose is displayed through the dose window 13, for example in multiples of the so-called international unit (IU). Here, 1 IU is bioequivalent to about 45.5 micrograms of pure crystalline insulin (1/22 mg). An example of the selected dose displayed in the dose window 13 can be, for example, 30 IU as shown in FIG. 1a. Note that the selected doses can be displayed equally well and differently, for example by an electronic display. A label (not shown) is provided on the housing 10. The label has information about the drug contained within the injection device, including information identifying the drug. The information that identifies the drug may be in the form of letters. The information that identifies the drug may be in the form of a color. The information that identifies the drug may be encoded in a barcode, QR code, or the like. The information that identifies the drug may be in the form of a black-and-white pattern, a color pattern, or a shade.

Turning the dose knob 12 produces a mechanical click to give acoustic feedback to the user. The number displayed on the dose window 13 is printed on a sleeve contained in the housing 10 and mechanically interacting with the piston in the insulin container 14. When the injection button 11 is pressed after the needle 15 has been punctured into the skin portion of the patient, the insulin dose displayed on the display window 13 is released from the injection device 1. After the injection button 11 is pressed, if the needle 15 of the injection device 1 remains in the skin portion for a period of time, a high percentage of the dose is actually injected into the patient's body. The release of the insulin dose also produces a mechanical click, which is different from the sound produced when using the dose knob 12.

The injection device 1 can be used for multiple injection processes until the insulin container 14 is empty or the expiration date of the injection device 1 (eg, 28 days from the first use) is reached.

Further, before using the injection device 1 for the first time, for example, by selecting two insulin units and by pressing the injection button 11 while holding the injection device 1 with the needle 15 pointing upwards, the insulin container 14 And it may be necessary to perform a so-called "prime shot" to remove air from the needle 15.

For simplicity, the release dose roughly corresponds to the injection dose, so for example, the next time you propose a dose to be injected, this dose should be equal to the dose that must be released by the injection device. It is assumed below as an example. Nevertheless, the difference between the release dose and the injection dose (eg loss) can of course be taken into account.

FIG. 1b is an enlarged view of an end portion of the injection device 1. This figure shows a positioning rib 70 located between the observation window 13 and the dose knob 12.

FIG. 2a is a schematic view of an embodiment of an auxiliary device 2 to be releasably attached to the injection device 1 of FIG. 1a. The auxiliary device 2 comprises a housing 20 having a fitting unit configured to surround the housing 10 of the injection device 1 of FIG. 1a, wherein the auxiliary device 2 sits snugly against the housing 10 of the injection device 1. Instead, for example, when the injection device 1 is empty and must be replaced, it can be removed from the injection device 1. FIG. 2a is very schematic and the details of the physical arrangement will be described below with reference to FIG. 2b.

The auxiliary device 2 includes an optical sensor and an acoustic sensor for collecting information from the injection device 1. At least a portion of this information, eg, a selected dose (and optionally a unit of this dose), is displayed through the display unit 21 of the auxiliary device 2. The dose window 13 of the injection device 1 is closed by the auxiliary device 2 when attached to the injection device 1.

Auxiliary device 2 further comprises three user input transducers, schematically represented as buttons 22. These input transducers 22 allow the user to turn auxiliary device 2 on and off to trigger an action (eg, establish a connection or pairing with another device, and / or from auxiliary device 2 to another device. (Trigger information transmission to), or something can be confirmed.

FIG. 2b is a schematic diagram of a second embodiment of an auxiliary device 2 that is to be releasably attached to the injection device 1 of FIG. 1a. The auxiliary device 2 comprises a housing 20 having a fitting unit configured to surround the housing 10 of the injection device 1 of FIG. 1a, wherein the auxiliary device 2 sits snugly against the housing 10 of the injection device 1. It is designed to be removable from the injection device 1.

Information is displayed through the display unit 21 of the auxiliary device 2. The dose window 13 of the injection device 1 is closed by the auxiliary device 2 when attached to the injection device 1.

Auxiliary device 2 further comprises three user input buttons or switches. The first button 22 is a power on / off button that allows the auxiliary device 2 to be turned on and off, for example. The second button 33 is a communication button. The third button 34 is a confirmation or OK button. Buttons 22, 33, 34 may be mechanical switches of any suitable shape. These input buttons 22, 33, 34 allow the user to turn the auxiliary device 2 on and off to trigger an action (eg, establish a connection or pairing with another device, and / or the auxiliary device 2). Trigger the transmission of information from to another device), or something can be confirmed.

FIG. 2c is a schematic view of a third embodiment of the auxiliary device 2 to be releasably attached to the injection device 1 of FIG. 1a. The auxiliary device 2 comprises a housing 20 having a fitting unit configured to surround the housing 10 of the injection device 1 of FIG. 1a, wherein the auxiliary device 2 sits snugly against the housing 10 of the injection device 1. It is designed to be removable from the injection device 1.

Information is displayed through the display unit 21 of the auxiliary device 2. The dose window 13 of the injection device 1 is closed by the auxiliary device 2 when attached to the injection device 1.

The auxiliary device 2 further includes a touch sensor type input transducer 35. The auxiliary device 2 also includes a single user input button or switch 22. Button 22 is a power on / off button that allows the auxiliary device 2 to be turned on and off, for example. A touch-sensitive input transducer 35 is used to trigger an action (eg, to establish a connection or pairing with another device and / or to trigger the transmission of information from auxiliary device 2 to another device). Or you can check something.

3a and 3b show the possible functional distribution between devices when an auxiliary device (such as the auxiliary device of FIGS. 2a and 2b) is used with an injection device.

In arrangement 4 of FIG. 3a, an auxiliary device 41 (such as the auxiliary device of FIGS. 2a and 2b) determines information from the injection device 40 and glycemics this information (eg, the type and / or dose of the drug to be injected). Provided to the monitoring system 42 (eg, by wired or wireless connection).

The blood glucose monitoring system 42 (which can be embodied as, for example, a desktop computer, mobile information terminal, mobile phone, tablet computer, laptop, netbook, or ultrabook) records the injections the patient has received so far. (For example, by assuming that the release dose and injection dose are the same, or by determining the injection dose based on the release dose, for example, assuming that the patient has not completely received a given percentage of the release dose. By doing so (based on the release dose). The blood glucose monitoring system 42 proposes, for example, the type and / or dose of insulin for the next injection of this patient. This proposal is for one or more past injections received by the patient and the current blood glucose level measured by the glucose meter 43 and provided to the blood glucose monitoring system 42 (eg, by wired or wireless connection). It may be based on the information of. Here, the glucose meter 43 is embodied as a separate device configured to receive a patient's small blood probe (eg, on a carrier material) and determine the patient's blood glucose level based on this blood probe. can do. However, the glucose meter 43 may be a device that is temporarily implanted in the patient, eg, the patient's eye or subcutaneously.

FIG. 3b is a modified arrangement 4'that results in the modified blood glucose monitoring system 42'of FIG. 3b by including the blood glucose meter 43 of FIG. 3a in the blood glucose monitoring system 42 of FIG. 3a. The functions of the injection device 40 and the auxiliary device 41 in FIG. 3a are not affected by this modification. In addition, the functions of the blood glucose monitoring system 42 and the blood glucose meter 43 combined with the blood glucose monitoring system 42'are included in the same device, so that external wired or wireless communication between these devices is performed. Basically does not change, except that is no longer needed. However, communication between the blood glucose monitoring system 42 and the blood glucose meter 43 takes place within the system 42'.

FIG. 4 shows a schematic view of the auxiliary device 2 of FIG. 2a, which is attached to the injection device 1 of FIG. 1a.

The housing 20 of the auxiliary device 2 includes a plurality of members. These are controlled by a processor 24, which may be, for example, a microprocessor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), or the like. The processor 24 executes program code (eg, software or firmware) stored in program memory 240 and uses main memory 241 to store, for example, intermediate results. The main memory 241 can also be used to store a logbook of releases / injections made. The program memory 240 may be, for example, a read-only memory (ROM), and the main memory may be, for example, a random access memory (RAM).

In an embodiment as shown in FIG. 2b, the processor 24 interacts with the first button 22 which allows the auxiliary device 2 to be turned on and off, for example. The second button 33 is a communication button. The second button can be used to trigger the establishment of a connection with another device or the transmission of information to another device. Third button 34
Is a confirmation or OK button. The third button 34 can be used to approve the information presented to the user of the auxiliary device 2. In the embodiment as shown in FIG. 2c, the two buttons 33 and 34 may be omitted. Instead, one or more capacitive sensors or other touch sensors are provided.

The processor 24 controls a display unit 21, which is currently embodied as a liquid crystal display (LCD). The display unit 21 is used to display to the user of the auxiliary device 2 information about, for example, the current configuration of the injection device 1 or the next injection to be made. Further, the display unit 21 may be embodied as, for example, a touch screen display for receiving user input.

The processor 24 also controls an optical sensor 25, which is embodied as an optical character recognition (OCR) reader. The OCR reader is capable of capturing an image of the dose window 13 displaying the current selected dose (by a number printed on the sleeve 19 included in the injection device 1 that can be seen through the dose window 13). The OCR reading device 25 can further recognize characters (for example, numbers) from the captured image and provide this information to the processor 24. Alternatively, the unit 25 of the auxiliary device 2 may be only an optical sensor, such as a camera, for capturing an image and providing information about the captured image to the processor 24. The processor 24 is then involved in executing the OCR of the captured image.

The numbers shown in the display window 13 of the injection device 1 can include odd and / or even numbers.

The processor can convert the information from the captured image into the scheduled information shown in the display unit 21 of the auxiliary device 2. The information shown on the display unit 21 can be an image or display or reproduction of image information. The information shown on the display unit 21 may be an image or an interpretation of the image information.

For example, the display window 13 of the injection device 1 can indicate the numbers "12" and "14", the center of which corresponds to the dose of "13 units". The processor can control the display to indicate the display or reproduction of the image, i.e. the display can indicate the numbers "12" and "14".

The processor 24 can interpret the image information and convert it into the scheduled information shown in the display unit 21. Taking the above example, the image processor 24 can interpret the image information to correspond to a dose of "13 units" and transform the information accordingly. The processor 24 controls the display unit 21 to indicate the interpretation of the image. The display unit 21 can indicate, for example, "13" or "13 units".

The processor 24 also controls a light source such as a light emitting diode (LED) 29 to illuminate the dose window 13 on which the current selected dose is displayed. For example, a diffuser made of a single piece of acrylic glass may be used in front of the light source. In addition, the optical sensor can include a lens (eg, an aspherical lens) that provides magnification (eg, magnification greater than 3: 1).

The processor 24 further controls a photometer 26 configured to determine the optical properties of the housing 10 of the injection device 1, such as color or shading. The optical property may be only in a specific portion of the housing 10, for example the color or color coding of the insulin container contained within the sleeve 19 or injection device 1, which color or color coding may be, for example, the housing 10 (and). / Or it may be visible through an additional window in the sleeve 19). Information about this color is then provided to the processor 24, which can determine the type of injection device 1 or the type of insulin contained in the injection device 1 (eg, purple SoloStar Lantus and blue). SoloStar Apidra). Alternatively, the camera unit can be used in place of the photometer 26, after which an image of the housing, sleeve, or insulin container is provided to the processor 24 and image processing is performed to color the housing, sleeve, or insulin container. Can be determined. In addition, one or more light sources may be provided to improve the reading of the photometer 26. The light source can provide light of a certain wavelength or spectrum to improve color detection by the photometer 26. The light source can be arranged, for example, to avoid or reduce unwanted reflections by the dose window 13. In an exemplary embodiment, a camera unit is placed in place of or in addition to the photometer 26 to the injection device and / or the drug-related code contained within the injection device (eg, eg, eg). A barcode that can be a one-dimensional or two-dimensional barcode) can be detected. The code may be located, for example, in the housing 10 or the drug container contained in the injection device 1, to name a few. The code can indicate, for example, the type of injection device and / or drug, and / or additional properties (eg, expiration date).

The processor 24 further controls (and / or receives a signal from the acoustic sensor 27) an acoustic sensor 27 configured to sense the sound generated by the injection device 1. Such sounds are heard, for example, when dialing the dose by turning the dose knob 12 and / or when the dose is released / injected by pressing the injection button 11 and / or when a prime shot is made. Can occur in. These actions are mechanically similar, but nevertheless emit different sounds (this can also be true for electronic sounds that indicate such actions). The acoustic sensor 27 and / or the processor 24 can be configured to distinguish between these different sounds and safely recognize, for example, that an injection has been made (not just a prime shot).

The processor 24 further controls the acoustic signal generator 23, which is configured to generate, for example, an acoustic signal that may be related to the operating state of the injection device 1, eg, as feedback to the user. .. For example, the acoustic signal can be generated by the acoustic signal generator 23 as a signal for the next dose to be injected, or, for example, as a warning signal in case of misuse. The acoustic signal generator may be embodied as, for example, a buzzer or a speaker. A tactile signal generator (not shown) may be used in addition to or in place of the acoustic signal generator 23 to provide tactile feedback, for example by vibration.

The processor 24 controls a wireless unit 28 configured to wirelessly transmit and receive information to another device. Such transmissions may be based on, for example, wireless or optical transmissions. In some embodiments, the radio unit 28 is a Bluetooth transceiver. Alternatively, the wireless unit 28 can be replaced or supplemented by a wired unit configured to send and receive information to and from another device, for example, by wire over a cable or fiber connection. When data is transmitted, the unit of transmitted data (value) can be clearly or implicitly defined. For example, in the case of insulin doses, international units (IUs) can always be used, or the units used can be clearly communicated, for example in the form of codes.

The processor 24 receives input from a pen detection switch 30, which can operate to detect the presence or absence of the pen 1, i.e., whether or not the auxiliary device 2 is coupled to the injection device 1.

The battery 32 supplies power to the processor 24 and other components by means of a power source 31.

Therefore, the auxiliary device 2 of FIG. 4 can determine information related to the condition and / or use of the injection device 1. This information is displayed on the display 21 for use by the user of the device. The information may be processed by the auxiliary device 2 itself or at least partially provided to another device (eg, a blood glucose monitoring system).

5a-5c are flowcharts of embodiments of the method according to the invention. These methods can be performed, for example, by the processor 24 of the auxiliary device 2 (see FIGS. 2b and 4) and by the processor of the auxiliary device 2 of FIG. 2b and, for example, in the form of the tangible storage medium 60 of FIG. It can be stored in, for example, the program memory 240 of the auxiliary device 2.

FIG. 5a shows the information read from the injection device 40 by the auxiliary device 41 provided to the blood glucose monitoring system 42 or 42'and does not receive the information returned from the blood glucose monitoring system 42 or 42', FIG. 3a and FIG. A method step performed in the situation shown in FIG. 3b is shown.

Flowchart 500 begins, for example, when the auxiliary device is turned on or otherwise activated. In step 501, certain types of agents, such as insulin, supplied by the injection device are determined, for example, based on color recognition, as described above, or recognition of the code printed on the injection device or its components. Will be done. If the patient regularly uses the same type of drug and only uses the injection device with that one type of drug, drug type detection may not be necessary. In addition, drug type determination can be made in other ways (eg, the keys and recesses shown in FIG. 4 where the auxiliary device can only be used with one particular injection device capable of supplying only this one type of drug. It may be done reliably (by pair).

In step 502, the current selected dose is determined, for example, by the OCR of the information shown in the dose window of the injection device described above. This information is then displayed to the user of the injection device in step 503.

In step 504, it is confirmed by sound recognition, for example, as described above, whether or not the emission has been performed. Here, the prime shot can be distinguished from the actual injection (to a person) based on the different sounds produced by the injection device and / or the release dose (eg, a predetermined amount of units). Small doses, eg less than 4 or 3 units, are considered to belong to prime shots, while larger doses are considered to belong to the actual injection).

When the release occurs, the determined data, i.e. the selected dose and, if necessary, the type of drug (eg insulin) is stored in main memory 241 from which later another device, eg blood glucose monitoring. -Can be sent to the system. If a distinction is made regarding the nature of the release, for example if the release was made as a prime shot or an actual injection, this information may also be stored in main memory 241 and optionally transmitted later. If the injection was made, the dose is shown on the display 21 in step 505. The time since the last injection, which is 0 or 1 minute immediately after the injection, is also displayed. The time from the last dose can be displayed intermittently. For example, the time may alternate with the name of the injected drug or other identification, such as Apidra or Lantus.

If the release was not performed in step 504, steps 502 and 503 are repeated.

After displaying the delivered dose and time data, Flowchart 500 ends.

FIG. 5b shows a more detailed exemplary method step performed when the selected dose is determined based on the use of optical sensors only. For example, these steps can be performed in step 502 of FIG. 5a.

In step 901, the sub-image is captured by an optical sensor such as the optical sensor 25 of the auxiliary device 2. The captured sub-image is, for example, the injection device 1 in which the current selected dose is displayed (eg, by a number and / or scale visible through the dose window 13 printed on the sleeve 19 of the injection device 1). It is an image of at least a part of the dose window 13. For example, the captured sub-image can show only a portion of the sleeve 19 that has low resolution and / or is visible through the dose window 13. For example, the captured sub-image shows a number or scale printed on the portion of the sleeve 19 of the injection device 1 that can be seen through the dose window 13. After the image is captured, it is further processed, for example:
Split by previously captured background image;
Bin the image and reduce the number of pixels for further evaluation;
Normalize the image to reduce lighting intensity fluctuations;
Image orientation; and / or image binarization by comparing constant thresholds.

For example, if a sufficiently large optical sensor (eg, a sensor having sufficiently large pixels) is used, some or all of these steps may be omitted, if applicable.

In step 902, it is determined whether or not there is a change in the captured sub-image. To determine if there is a change, for example, the current captured sub-image can be compared to the previously captured sub-image. Here, the comparison with the previously captured sub-image is that the sub-image of the previously captured sub-image captured immediately before the current sub-image is captured, and / or before the current sub-image is captured. Can be limited to sub-images of previously captured sub-images captured within a particular time period (eg 0.1 seconds). The comparison may be based on image analysis techniques such as pattern recognition performed on the current captured sub-image and the previously captured sub-image. For example, it is possible to see through the dose window 13 and analyze whether the scale and / or number patterns shown in the current capture sub-image and the previously captured sub-image have changed. For example, you can search for patterns in an image that have a certain size and / or aspect ratio and compare these patterns with pre-stored patterns. Steps 901 and 902 can correspond to the detection of changes in the captured image.

If it is determined in step 902 that there is a change in the sub-image, step 901 is repeated. Otherwise, in step 903, the image is captured by an optical sensor such as the optical sensor 25 of the auxiliary device 2. For example, the captured image shows the current selected dose (eg, by the number and / or scale printed on the sleeve 19 of the injection device 1, which can be viewed through the dose window 13), the dose of the injection device 1. It is an image of a window 13. For example, the captured image can have a higher resolution than the resolution of the captured sub-image. The captured image shows at least the numbers printed on the sleeve 19 of the injection device 1 which can be seen through the dose window 13.

In step 904, optical character recognition (OCR) is performed on the image captured in step 903 to recognize the numbers printed on the sleeve 19 of the injection device 1 that can be seen through the dose window 13. .. This is because these numbers correspond to the (current) selective dose. The selected dose is determined according to the recognized number, for example, by setting a value representing the selected dose to the recognized number.

In step 905, it is determined whether or not there is a change in the determined selective dose, and in some cases, whether or not the determined selective dose is non-zero. For example, the currently determined selective dose can be compared to the previously determined selective dose to determine if there is a change. Here, the comparison with the previously determined selective dose is limited to the previously determined selective dose determined within a specific period (eg, 3 seconds) prior to the current selective dose being determined. be able to. If there is no change in the determined selective dose and, in some cases, the determined selective dose is non-zero, the currently determined selective dose is returned / directed (eg, to processor 24) for further processing.

Therefore, more than 3 seconds after the last rotation of the dose knob 12, the selected dose is determined. If the dose knob 12 is rotated within or after this 3 seconds and the new position remains unchanged for more than 3 seconds, this value is taken as the determined selective dose.

FIG. 5c shows a more detailed method step performed when the selected dose is determined based on the use of acoustic and optical sensors. For example, these steps can be performed in step 502 of FIG. 5a.

In step 1001, sound is captured by an acoustic sensor such as the acoustic sensor 27 of the auxiliary device 2.

In step 1002, it is determined whether or not the capture sound is a click sound. The uptake sound is, for example, when the dose is dial-measured by rotating the dose knob 12 of the injection device 1 and / or when the dose is released / injected by pressing the injection button 11 and / or prime. -It can be a click sound that occurs when a shot is made. If the captured sound is not a click sound, step 1001 is repeated. Otherwise, in step 1003, the image is captured by an optical sensor such as the optical sensor 25 of the auxiliary device 2. Step 1003 corresponds to step 903 in Flowchart 900.

In step 1004, OCR is executed on the image captured in step 1003. Step 1004 corresponds to step 904 in Flowchart 900.

In step 1005, it is determined whether or not there is a change in the determined selective dose, and in some cases, whether or not the determined selective dose is not zero. Step 1005 corresponds to step 905 in Flowchart 900.

There may be a slight advantage of the acoustic approach shown in FIG. 5c with respect to the power consumption of the auxiliary device. This is because permanently capturing an image or sub-image as shown in FIG. 5b generally consumes more power than listening to an acoustic sensor such as a microphone.

FIG. 6 is a schematic diagram of a tangible storage medium 600 (computer program product) including a computer program 601 having a program code 602. This program code can be executed, for example, by a processor included in the auxiliary device, for example, the processor 24 of the auxiliary device 2 of FIGS. 2 and 4. For example, the storage medium 600 can represent the program memory 240 of the auxiliary device 2 of FIG. The storage medium 600 may be a fixed memory or a removable memory such as a memory stick or a memory card.

As described in detail above, embodiments of the present invention allow standard injection devices, especially insulin devices, to be connected to a blood glucose monitoring system in a useful and productive manner.

Embodiments of the present invention introduce auxiliary devices to enable this connection, assuming that the blood glucose monitoring system has wireless or other communication capabilities.

The advantage of connecting glycemic monitoring with an insulin injection device is, among other things, to reduce user error and handling steps of the injectable device, based on glycemic monitoring, especially the last injected dose and last glycemic level. It eliminates the need to manually transfer the injected insulin unit to a glycemic monitoring system that has the ability to guide the next dose.

As described for the exemplary embodiments above, when the user / patient obtains a new insulin pen, the user attaches an auxiliary device to the pen. The auxiliary device reads the injection dose. The auxiliary device can also transfer the injection dose to the glycemic monitoring system by means of the insulin titration function. For patients taking large amounts of insulin, the auxiliary device can also recognize the device structure for the insulin type and send this information to the glycemic monitoring system.

In an exemplary embodiment, the information shown on the display, eg, the LCD displays 21 of FIGS. 2a and 4, is presented to the user by a text-to-speech function performed by the processor 24, eg, using an acoustic signal generator 23. Can be converted into an audio signal that is reproduced through the speaker. Therefore, visually impaired users can easily use the information of the auxiliary device 2 such as the dial-measured dose, the recommended dose, and the recommended administration time.

When using embodiments of the present invention, the user has, among other things, the following advantages:

The user can use the most convenient disposable insulin syringe.

Auxiliary devices are removable and removable (reusable).

The user can use the injection device in the same way as previously used. This is possible even though the display window 13 is covered by an auxiliary device.

The user can identify that the injection device is the correct one to use, and in particular can ensure that the injection device contains the correct drug. This is possible even though the drug information label on the injection device is partially covered by the auxiliary device.

Information on the injected dose can be automatically transmitted to the glycemic monitoring system (eliminating transmission errors). This provides improved dose guidance as the glycemic monitoring system calculates the dose to be taken.

It may be unnecessary to manually attach a data logbook.

In addition, when placing the auxiliary device proposed by the present invention, for example by receiving a warning signal after an appropriate time after the first dose of the drug (eg insulin or heparin) has been injected, The patient can also be reminded to inject the dose of.

The injection dose information is transmitted to any computerized system, eg, for any dose calculation or any other applicable treatment guidance calculation, or as an input for the generation of a warning signal, eg: Can remind the user to take the dose of.

As used herein, the term "drug" or "drug" means a pharmaceutical formulation comprising at least one pharmaceutically active compound.
Here, in one embodiment, the pharmaceutically active compound has a molecular weight of up to 1500 Da and / or peptides, proteins, polysaccharides, vaccines, DNA, RNA, enzymes, antibodies or fragments thereof, hormones. Alternatively, it is an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compounds.
Here, in a further embodiment, the pharmaceutically active compound is diabetes, or diabetes-related complications such as diabetic retinopathy, thromboembolism such as deep venous thromboembolism or pulmonary thromboembolism, acute coronary syndrome. (ACS), angina, myocardial infarction, cancer, luteal degeneration, inflammation, hay fever, atherosclerosis and / or useful for the treatment and / or prevention of rheumatoid arthritis.
Here, in a further embodiment, the pharmaceutically active compound comprises at least one peptide for the treatment and / or prevention of diabetic or diabetic retinopathy-related complications.
Here, in a further embodiment, the pharmaceutically active compound is at least one human insulin or a human insulin analog or derivative, a glucagon-like peptide (GLP-1) or an analog or derivative thereof, or exendin-3 or exendin. -4 or exendin-3 or an analog or derivative of exendin-4.

Insulin analogs include, for example, Gly (A21), Arg (B31), Arg (B32) human insulin; Lys (B3), Glu (B29) human insulin; Lys (B28), Pro (B29) human insulin; Asp ( B28) Human insulin; Proline at position B28 is replaced with Asp, Lys, Leu, Val, or Ala, and Lys may be replaced with Pro at position B29; Ala (B26) human insulin; Des (B28-B30) human insulin; Des (B27) human insulin, and Des (B30) human insulin.

Insulin derivatives include, for example, B29-N-myristoyl-des (B30) human insulin; B29-N-palmitoyl-des (B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28- N-Millistoyl LysB28ProB29 Human Insulin; B28-N-Palmitoyle-LysB28ProB29 Human Insulin; B30-N-Millistoyl-ThrB29LysB30 Human Insulin; B30-N-Palmitoyle-ThrB29LysB30 Human Insulin; -Des (B30) human insulin; B29-N- (N-lithocholyl-γ-glutamyl) -des (B30) human insulin; B29-N- (ω-carboxyheptadecanoyl) -des (B30) human insulin, and B29-N- (ω-carboxyheptadecanoyl) human insulin.

Exendin-4 is, for example, H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Gl.
u-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2 sequence Means exendin-4 (1-39), which is a peptide of.

Exendin-4 derivatives are, for example, compounds listed below:
H- (Lys) 4-desPro36, desPro37 Exendin-4 (1-39) -NH2,
H- (Lys) 5-desPro36, desPro37 Exendin-4 (1-39) -NH2,
desPro36 Exendin-4 (1-39),
desPro36 [Asp28] Exendin-4 (1-39),
desPro36 [IsoAsp28] Exendin-4 (1-39),
desPro36 [Met (O) 14, Asp28] Exendin-4 (1-39),
desPro36 [Met (O) 14, IsoAsp28] Exendin- (1-39),
desPro36 [Trp (O2) 25, Asp28] Exendin-4 (1-39),
desPro36 [Trp (O2) 25, IsoAsp28] Exendin-4 (1-39),
desPro36 [Met (O) 14, Trp (O2) 25, Asp28] Exendin-4 (1-39),
desPro36 [Met (O) 14Trp (O2) 25, IsoAsp28] Exendin-4 (1-39); or desPro36 [Asp28] Exendin-4 (1-39),
desPro36 [IsoAsp28] Exendin-4 (1-39),
desPro36 [Met (O) 14, Asp28] Exendin-4 (1-39),
desPro36 [Met (O) 14, IsoAsp28] Exendin- (1-39),
desPro36 [Trp (O2) 25, Asp28] Exendin-4 (1-39),
desPro36 [Trp (O2) 25, IsoAsp28] Exendin-4 (1-39),
desPro36 [Met (O) 14, Trp (O2) 25, Asp28] Exendin-4 (1-39),
desPro36 [Met (O) 14, Trp (O2) 25, IsoAsp28] Exendin-4 (1-39),
(Here, the group-Lys6-NH2 may be attached to the C-terminus of the exendin-4 derivative);

Alternatively, an exendin-4 derivative having the following sequence:
desPro36 Exendin-4 (1-39) -Lys6-NH2 (AVE0010),
H- (Lys) 6-desPro36 [Asp28] Exendin-4 (1-39) -Lys6-NH2,
desAsp28Pro36, Pro37, Pro38 Exendin-4 (1-39) -NH2,
H- (Lys) 6-desPro36, Pro38 [Asp28] Exendin-4 (1-39) -NH2,
H-Asn- (Glu) 5desPro36, Pro37, Pro38 [Asp28]
Exendin-4 (1-39) -NH2,
desPro36, Pro37, Pro38 [Asp28] Exendin-4 (1-39)-(Lys) 6-NH2,
H- (Lys) 6-desPro36, Pro37, Pro38 [Asp28] Exendin-4 (1-39)-(Lys) 6-NH2,
H-Asn- (Glu) 5-desPro36, Pro37, Pro38 [Asp28] Exendin-4 (1-39)-(Lys) 6-NH2,
H- (Lys) 6-desPro36 [Trp (O2) 25, Asp28] Exendin-4 (1-39) -Lys6-NH2,
H-desAsp28Pro36, Pro37, Pro38 [Trp (O2) 25] Exendin-4 (1-39) -NH2,
H- (Lys) 6-desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin-4 (1-39) -NH2,
H-Asn- (Glu) 5-desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin-4 (1-39) -NH2,
desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin-4 (1-39)-(Lys) 6-NH2,
H- (Lys) 6-desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin-4 (1-39)-(Lys) 6-NH2,
H-Asn- (Glu) 5-desPro36, Pro37, Pro38 [Trp (O2) 25, Asp28] Exendin-4 (1-39)-(Lys) 6-NH2,
H- (Lys) 6-desPro36 [Met (O) 14, Asp28] Exendin-4 (1-39) -Lys6-NH2,
desMet (O) 14, Asp28Pro36, Pro37, Pro38 Exendin-4 (1-39) -NH2,
H- (Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin-4 (1-39) -NH2,
H-Asn- (Glu) 5-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin-4 (1-39) -NH2;
desPro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin-4 (1-39)-(Lys) 6-NH2,
H- (Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin-4 (1-39)-(Lys) 6-NH2,
H-Asn- (Glu) 5desPro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin-4 (1-39)-(Lys) 6-NH2,
H-Lys6-desPro36 [Met (O) 14, Trp (O2) 25, Asp28] Exendin-4 (1-39) -Lys6-NH2,
H-desAsp28, Pro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25] Exendin-4 (1-39) -NH2,
H- (Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Asp28] Exendin-4 (1-39) -NH2,
H-Asn- (Glu) 5-desPro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] Exendin-4 (1-39) -NH2,
desPro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] Exendin-4 (1-39)-(Lys) 6-NH2,
H- (Lys) 6-desPro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] Exendin-4 (S1-39)-(Lys) 6-NH2,
H-Asn- (Glu) 5-desPro36, Pro37, Pro38 [Met (O) 14, Trp (O2) 25, Asp28] Exendin-4 (1-39)-(Lys)
6-NH2;
Alternatively, it is selected from pharmaceutically acceptable salts or solvates of any one of the above exendin-4 derivatives.

Hormones include, for example, gonadotropins (follitropin, lutropin, corion gonadotropin, menotropin), somatropin (somatropin), desmopressin, telluripresin, gonadorelin, triptorelin, leuprorelin, busererin, nafarelin, gosereline, etc. Pituitary hormones or hypothalamic hormones or regulatory active peptides listed in and their antagonists.

Examples of the polysaccharide include glucosaminoglycan, hyaluronic acid, heparin, low molecular weight heparin, or ultra low molecular weight heparin, or derivatives thereof, or sulfated forms of the above-mentioned polysaccharides, for example, polysulfated forms, and / Or there are pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium.

The antibody is a globular plasma protein (about 150 kDa), also known as an immunoglobulin that shares a basic structure. These are glycoproteins because they have sugar chains added to amino acid residues. The basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only one Ig unit), and secretory antibodies are also dimers, bone fish, having two Ig units such as IgA. It can also be a tetramer with four Ig units, such as IgM, or a pentamer with five Ig units, such as mammalian IgM.

The Ig monomer is a "Y" -shaped molecule composed of four polypeptide chains, that is, two identical heavy chains and two identical light chains linked by disulfide bonds between cysteine residues. Is. Each heavy chain is about 440 amino acids long and each light chain is about 220 amino acids long. The heavy and light chains each contain an intrachain disulfide bond that stabilizes these folded structures. Each strand is composed of a structural domain called the Ig domain. These domains contain about 70-110 amino acids and are classified into different categories (eg, variable or V, and stationary or C) based on their size and function. They have a characteristic immunoglobulin folding structure that creates a "sandwich" shape in which the two β-sheets are held together by the interaction between the conserved cysteine and other charged amino acids.

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

Different heavy chains differ in size and composition, α and γ contain about 450 amino acids, δ contains about 500 amino acids, and μ and ε have about 550 amino acids. Each heavy chain has two regions, a constant region ( _CH ) and a variable region ( _VH ). In one species, the constant region is essentially the same for all antibodies of the same isotype, but different for antibodies of different isotypes. The heavy chains γ, α, and δ have a stationary region composed of three tandem Ig domains and a hinge region for adding flexibility, and the heavy chains μ and ε have four immunoglobulins. -Has a stationary region composed of domains. The variable region of the heavy chain is different for antibodies produced by different B cells, but is the same for all antibodies produced by a single B cell or B cell clone. The variable region of each heavy chain is approximately 110 amino acids long and is composed of a single Ig domain.

In mammals, there are two types of immunoglobulin light chains represented by λ and κ. The light chain has two contiguous domains, one constant domain (CL) and one variable domain (VL). The approximate length of the light chain is 211-217 amino acids. Each antibody always has two light chains that are identical, and for each mammalian antibody there is only one type of light chain κ or λ.

Although the general structure of all antibodies is very similar, the unique properties of a given antibody are determined by the variable (V) region, as detailed above. More specifically, three variable loops on each light chain (VL) and three on the heavy chain (HV) are involved in binding to the antigen, i.e. its antigen specificity. These loops are called complementarity determining regions (CDRs). Since CDRs from both the VH and VL domains contribute to the antigen binding site, it is the combination of heavy and light chains that determines the final antigen specificity, not either alone.

An "antibody fragment" comprises at least one antigen binding fragment as defined above and exhibits essentially the same function and specificity as the complete antibody from which the fragment is derived. Limited protein digestion with papain cleaves the Ig prototype into three fragments. Two identical amino-terminal fragments, each containing one complete L chain and about half the H chain, are antigen-binding fragments (Fabs). The third fragment, which is comparable in size but contains a carboxyl terminus at half of both heavy chains with interchain disulfide bonds, is a crystallizable fragment (Fc). Fc includes carbohydrates, complementary binding sites, and FcR binding sites. Limited pepsin digestion results in a single F (ab') 2 fragment containing both the Fab fragment and the hinge region containing the H-H interchain disulfide bond. F (ab') 2 is divalent for antigen binding. The disulfide bond of F (ab') 2 can be cleaved to obtain Fab'. In addition, the variable regions of the heavy and light chains can be condensed to form single chain variable fragments (scFv).

Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts. Acid addition salts include, for example, HCl or HBr salts. The basic salt is, for example, an alkali or alkaline earth, for example, a cation selected from Na +, K +, or Ca2 +, or ammonium ion N + (R1) (R2) (R3) (R4) (in the formula, R1). ~ R4 are independent of each other: hydrogen, optionally substituted C1-C6 alkyl groups, optionally substituted C2-C6 alkenyl groups, optionally substituted C6-C10 aryl groups, or optionally substituted C6 to A salt having a C10 heteroaryl group). Further examples of pharmaceutically acceptable salts are described in "Remington's Pharmaceutical Sciences" 17th Edition, Alphanso R. et al. Gennaro (eds.), Mark Publishing Company, Easton, Pa. , U.S. S. A. , 1985 and Encyclopedia of Pharmaceutical Technology.

A pharmaceutically acceptable solvate is, for example, a hydrate.

Next, with reference to FIGS. 8 to 14, the mechanical arrangement of one embodiment of the auxiliary device 2 and the method of attaching to the injection device 1 will be described.

As most often seen in FIG. 8, the auxiliary device 2 is the injection pen 1 near the dose knob 12 with the display 21 at the top in the illustrated orientation (similar for all of FIGS. 8-14). Attached to. The plane of the display 21 is located substantially laterally with respect to the vertical axis of the injection device 1 and is perpendicular to the paper surfaces of FIGS. 8, 9, 10, 12, 13, and 14.

The closure 68 extends from the hinge shaft 59 and extends below the injection pen. The closure 68 is connected to the auxiliary device 2 on the right side (looking at the injection device 1 with the injection button closest to the viewer), extends below the injection pen 1 and connects to the auxiliary device on the left side. To do.

The auxiliary device 2 of these illustrated embodiments has two functions that contribute to the correct alignment of the auxiliary device 2 on the injection device 1 and one function of fixing the auxiliary device 2 to the injection device 1. The function that contributes to the correct alignment of the auxiliary device 2 on the injection device 1 can be called the alignment arrangement. The function that contributes to the fixation of the auxiliary device 2 to the injection device 1 can be called a fixed arrangement.

Correct alignment of the auxiliary device 2 on the injection device 1 ensures that the OCR reader 25 is correctly aligned with the dose window 13. Correct alignment ensures correct operation and reliable reading. A simpler design for the OCR reader 25 because the auxiliary device 2 and the injection device 1 can be reliably and correctly aligned during use, and in particular, it does not need to be designed to accommodate different alignments between the devices 1 and 2. Becomes possible.

The first alignment function is the positioning channel 71. The positioning channel 71 is located at the top of the injection device receiving channel 58 defined between the body of the auxiliary member and the closure 68 when in the closed position.

The positioning channel 71 is most commonly found in FIGS. 11a and 11b. From this, it will be seen that when the auxiliary device 2 is attached to the injection device 1, a positioning channel is formed at the end of the auxiliary device closest to the dose knob 12.

As most often seen in FIG. 1b, the positioning rib 70 is located between the display window 13 and the dose knob 12. In this example, the positioning rib 70 extends over the entire distance between the display window 13 and the dose knob 12. In another example, the positioning ribs are shorter. The positioning rib 70 is higher at the end adjacent to the dose knob 12 and is tapered so that the height is zero at the junction with the display window 13. As can be seen from FIG. 1b, the taper at the uppermost edge of the positioning rib 70 is slightly curved. The slope of the taper is smaller at the portion of the positioning rib 70 closest to the dose knob 12 and larger along the positioning rib to the position of the display window 13. The shape of the positioning rib 70 is such that the gradient continuously increases as it moves from the position of the positioning rib 70 adjacent to the dose knob 12 to the position of the positioning rib 70 adjacent to the display window 13.

The thickness of the positioning rib 70, which is the dimension around the main body of the injection device 1, varies along the length of the positioning rib 70. The thickness of the positioning rib 70 is the largest at the end adjacent to the dose knob 12 and the smallest at the end adjacent to the display window 13. The thickness of the positioning rib 70 gradually decreases as it moves from the end of the positioning rib adjacent to the dose knob 12 to the end of the positioning rib adjacent to the display window 13.

The cross section of the positioning rib, which is a cross section taken perpendicular to the vertical axis of the injection pen 1, is a triangle with rounded corners. The cross section of the positioning rib 70 is substantially the same in terms of overall length, but of course the sizes are different.

The positioning channel 71 is sized to closely correspond to the shape and size of the positioning rib 70 on the injection pen 1.

The positioning channel 71 has a size and shape that closely corresponds to the size and shape of the positioning rib 70. The positioning channel 71 is slightly larger than the positioning rib so that the positioning rib can be reliably positioned within the positioning channel 71. When the positioning rib 70 is in the positioning channel 71, the corresponding size ensures that the two functions fit together. This helps ensure correct positioning of the auxiliary device 2 on the injection device 1.

Next, other functions of the auxiliary device 2 and the injection pen 1 that help ensure correct alignment between the two devices will be described. As most often seen in FIG. 1b, the injection pen 1 is provided with recesses on both sides of the body near the dose knob 12. In FIG. 1b, the recess 52 on the left side is shown. The right recess 51 shown in FIGS. 10 and 12 is at the corresponding position on the right side of the injection pen 1.

The left and right recesses 51 and 52 are relatively shallow recesses. The recesses 51, 52 have inclined sides, i.e., the sides of the recesses 51, 52 are not parallel. Further, the dents 51 and 52 are not in the radial direction with respect to the vertical axis of the injection pen 1. In these embodiments, the lateral inclinations of the left and right recesses 51, 52 are different for the different portions of the recess. In particular, the slope of the inclination of the side portion of the recess is smaller at the recess portion farthest from the display window 13, and is largest at the recesses 51 and 52 closest to the display window 13. In these examples, the slope of the recess changes, for example, linearly between these two ends.

The inclination of the side portion of the recess can be, for example, 30 to 70 degrees at the portion farthest from the display window 13. The tilt can be, for example, 60-80 degrees for the portion closest to the display window 13. The larger the tilt angle in the portion closer to the display window 13, the more resistance to the removal of the auxiliary device 2 in the radial direction with respect to the vertical axis of the injection device 1 so as to provide some resistance to the removal of the auxiliary device 2 in the recesses 51, 52. Helps engage.

As most often seen in FIGS. 10 and 11, the left and right protrusions 53, 54 are formed to correspond to the respective shapes of the right and left recesses 51, 52. Thus, when the auxiliary device 2 is correctly positioned on the injection pen 1, the right and left protrusions 53, 54 fit into the respective interiors of the right and left recesses 51, 52. The outer dimensions of the right and left protrusions 53, 54 are slightly smaller than the inner dimensions of the right and left protrusions 51, 52 to ensure that the protrusions fit inside the respective recesses.

In these embodiments, the left and right protrusions 52 are formed so as to closely correspond to the shape of the right recess 51. Thus, when the auxiliary device 2 is correctly positioned on the injection pen 1, the right protrusion 53 fits snugly into the right recess 51. The left protrusion 54 is formed in the same manner as the right protrusion 53, but is lower than the right protrusion 53. In other words, the left protrusion 54 is similar to the right protrusion 53, but has no upper part or is cut off. This is the reason why the end face of the left protrusion 54 has a larger area than the right protrusion 53. The different sizes of the protrusions 53, 54 help the protrusions engage in the recesses 51, 52. It may be considered that the right protrusion 53 is the main and the left protrusion is the slave.

As best shown in FIG. 11b, the right protrusion 53 is located at the end of the right arm 55.

As seen in FIG. 11a, the left protrusion 54 is located at the end of the left arm 56.

As most often seen in FIG. 10, the right arm and the left arms 55, 56 hang substantially perpendicular to the body 20 of the auxiliary device 2. Therefore, the right arm and the left arms 55, 56 are formed on both sides of the injection device receiving channel 58.

A U-shaped spring-shaped urging function 67 is connected to the right and left arms 55, 56, respectively. The effect of the spring 67 is to urge the right and left arms to a certain position. The positions where the right and left arms 55 and 56 are urged are such that the distance between the innermost surfaces of the right and left protrusions 53 and 54 is slightly smaller than the distance between the bottoms of the right and left recesses 51 and 52. Is. The effect of the spring 67 is to resist the distant movement of the protrusions 53, 54 and the arms 55, 56.

Since the inclination of the side portions of the protrusions 53 and 54 coincides with the side portions of the recesses 51 and 52, the inclined side portions of the protrusions 53 and 54 at the distal ends of the arms 55 and 56 are relatively shallow. This helps slide the protrusions 53, 54 on the outer surface of the body 10 of the injection pen 1 when the auxiliary device is attached. This is best shown with reference to FIGS. 10 and 12.

As shown in FIG. 10, the auxiliary device 2 is positioned relative to the injection pen 1 so that the ends of the right and left arms 55, 56, in particular the protrusions 53, 54, are in direct contact with the housing 10 of the injection pen 1. To do. The protrusions 53, 54 now contact the housing on the left and right sides of the display window 13.

The left and right arms 55, 56 are behind flaps 60 hanging from auxiliary device 2 on the left and right sides. As can be seen in FIG. 10, the flap or protective wall 60 extends slightly below the arm. The flap 60 is formed from a transparent material. This allows the user to see the positions of the arms 55, 56 with respect to the recesses 51, 52, which can help to properly position the auxiliary device 2 on the injection device 1. In FIG. 9, the position of the left recess 52 is indicated by a dotted line to emphasize the positions of the arms 55 and 56 and the recesses 51 and 52. The arm is not shown in this figure.

In order to fit the auxiliary device 2 into the injection device 1, the user first places the auxiliary device 2 with respect to the injection device 1, as shown in FIG. 10, and then exerts a downward force on the auxiliary device 2. At the same time as the addition, an upward force is applied to the injection device 1. This exerts a force on the protrusions 53, 54, and thus the right and left arms 55, 56. When the injection device 1 and the auxiliary device 2 come close to each other, the force causes the arm to separate against the elasticity of the spring 67. As a result, the spring 67 applies a reaction force to resist the injection device 1 from entering the injection device receiving channel 58. However, when the protrusions 53 and 54 reach the position of the injection pen 1 that directly coincides with the vertical axis of the injection device 1, the reaction force applied by the spring 67 is applied when both the injection device 1 and the auxiliary device 2 move further. It will not increase. After this, the movement of the injection pen 1 into the injection device receiving channel 58 is assisted by the elasticity of the spring 67.

After further movement, the protrusions 53, 54 align with the left and right recesses 51, 52 and engage the recesses by the elasticity of the spring 67. Engagement provides tactile and audio feedback when the protrusions 53, 54 click into the recesses 51, 52. The feedback is enhanced by the force given by the elasticity of the spring 67. When the protrusions 53, 54 are fitted into the recesses 51, 52, the arms 55, 56 are both urged, in part by the corresponding shapes of the protrusions 53, 54 and the recesses 51, 52, and in part by the spring 67. This creates a great deal of resistance to further movement of the auxiliary device 2 with respect to the injection device 1.

If one of the recesses 51, 52 is higher than the other when the auxiliary device 2 and the injection device 1 move together, one of the protrusions 53, 54 will be twisted before the other of the protrusions reaches the other recess. Engage on the higher side. In this case, the first contacting protrusions and dents engage, creating great resistance to further movement of the protrusions with respect to the dents. In this case, the injection device 1 naturally tends to rotate relative to the auxiliary device so that the other recess contacts the other protrusion. When the other recess contacts the other protrusion, they fit together, creating considerable resistance to further movement of the injection pen 1 with respect to the auxiliary device 2. In a situation where one of the protrusions touches the recesses before the other protrusion touches each recess, it seems to the user that the injection pen 1 and the auxiliary device 2 initially move together with little or no rotation. Is done. Tactile and audio feedback is then given when the first protrusion contacts the corresponding recess, after which the injection device 1 is placed in the injection device receiving channel 58 until the other protrusion is received by the other recess. Once in place, additional tactile and audio feedback will be given to the user at this point.

When the protrusions 53, 54 fit into the recesses 51, 52, the injection device 1 is completely positioned within the injection device receiving channel 58, as shown in FIG. Here, it can be seen that the outermost surface of the display window 13 is substantially aligned with the lowermost surface of the upper part of the auxiliary device 2. The auxiliary device 2 is fitted to the outer surface of the housing 10 of the injection device 1 and the auxiliary device 2 when the injection device 1 is snugly fitted within the injection device receiving channel 58 and the auxiliary device and the injection pen 1 are in this relative position. It is formed so that there are a plurality of points or regions in contact with the lowermost surface of the. At this point, the user will find that the injection pen 1 tends to sit in this position within the auxiliary device 2 even if the protrusions 53, 54 are not fitted into the recesses 51, 52. ..

The positioning rib 70 engages within the positioning channel 71 when the auxiliary device 2 is positioned relative to the injection pen 1 such that the right and left protrusions 53, 54 are located within the right and left recesses 51, 52, respectively. Thereby, the correct alignment of the auxiliary device 2 with respect to the injection device 1 can be achieved in two ways: first, by the position of the positioning rib 70 in the positioning channel 71, and secondly, the protrusions 53, 54 are recessed 51, 52. It is brought about by positioning it inside.

If the user places the auxiliary device 2 on the injection pen 1 in such a position that the auxiliary device 2 is slightly to the right of the position shown in FIG. 8, the positioning rib 70 does not fit into the positioning channel 71. In this case, the positioning rib 70 is placed on the surface of the auxiliary device 2 somehow distal to the correct position in the positioning channel 71 so that the auxiliary device 2 is completely positioned on the injection pen 1. I can't. However, at this position, the ends of the protrusions 53, 54 pass through the midpoint around the housing 10 of the injection device 1, so that the spring 67 positions the injection device 1 within the injection device receiving channel 58. Is urged to the auxiliary device 2 side. Since the user has not received the tactile feedback from the fitting of the protrusions 53 and 54 and the recesses 51 and 52, it can be seen that the auxiliary device 2 did not fit the injection pen 1 correctly. Also, the user can see that the distance of the end of the auxiliary device closest to the dose knob 12 away from the injection pen 1 is greater than the distance of the auxiliary device 2 away from the injection pen 1 at the end of the auxiliary device 2 distal to the dose knob 12. Notice that it is also big. In this situation, the user engages the auxiliary device 2 and the injection pen 1 by simply exerting a force on the auxiliary device 2 and the injection pen 1 to move the auxiliary device 2 to the left in the direction shown in FIG. Can be combined. This can be done with one or both hands. When the auxiliary device 2 and the injection device 1 move with respect to each other, the positioning rib and the positioning channel are further engaged. The spring force provided by the spring 67 can assist such relative movement between the auxiliary device 2 and the injection device 1. When the positioning rib 70 and the positioning channel 71 are further engaged, the end of the auxiliary device 2 closest to the dose knob 12 is lowered toward the injection device 1. This movement continues until the positioning rib 70 is completely inside the positioning channel 71, at which point the right and left protrusions 53, 54 also engage the right and left recesses 51, 52, respectively. At this point, tactile feedback is provided by the fitting of the protrusions 53, 54 and the recesses 51, 52, and the user determines that the auxiliary device 2 and the injection device 1 are properly positioned relative to each other. Can be done.

When the user positions the auxiliary device on the injection pen 1 so that the auxiliary device is to the left of the position shown in FIG. 8, the auxiliary device 2 and the injection pen 1 do not fit. In this case, the positioning rib 70 does not prevent the auxiliary device 2 from being positioned flat with respect to the injection pen 1. The user notices this and finds that the auxiliary device 2 is too far from the dose knob 12. The user can engage the auxiliary device 2 with the injection pen 1 by simply moving the auxiliary device 2 with respect to the injection device 1 and moving the auxiliary device 2 to the right in the direction shown in FIG.

If the positioning rib 70 is aligned with the positioning channel 71 when the end of the positioning rib 70 is closest to the display window 13, the smallest end of the positioning rib 70 enters the mouth, which is the large open end of the positioning channel 71. At this stage, the auxiliary device is still located on the surface of the injection device 1, and the injection device 1 is completely located within the injection device receiving channel 58. By the action of the spring 67, the injection device 1 is urged into the injection device receiving channel 58 against the auxiliary device 2 at this stage.

If the positioning rib 70 and the positioning channel 71 are not accurately aligned, the narrowest end of the positioning rib 70 engages the side of the positioning channel. Further longitudinal relative movement of the auxiliary device 2 and the injection device 1 exerts a reaction force between the positioning rib and the wall of the positioning channel 71 so that the auxiliary device 2 and the injection device 1 are perfectly aligned. To urge. This is done until the positioning rib 70 is fully engaged in the positioning channel 71, at which point the right and left protrusions 53, 54 also engage the right and left recesses 51, 52. At this point, the auxiliary device 2 and the injection device 1 are fully engaged with each other.

The auxiliary device 2 includes a closure 68, which has the main function of fastening the auxiliary device 2 to the injection pen 1 when the two devices fit together.

As most often seen in FIGS. 13 and 14, the closure 68 has an innermost surface that coincides with the curved surface of the virtual cylinder. The diameter of the cylinder is the same as the outer dimension of the housing 10 of the injection device 1. Thus, the closure 68 fits snugly into the bottom of the housing 10 of the injection device 1 when the auxiliary device 2 is in place on the injection device 1.

The closed portion 68 is movable between the open position shown in FIG. 13 and the closed position shown in FIG.

As seen in FIG. 8, the closure 68 is located adjacent to the arm protection wall 60 in the direction opposite to the dose knob 12 of the arm protection wall 60. The closure portion 68 has a dimension on the vertical axis of the injection pen 1 that is about 60% of the length dimension of the auxiliary device 2. In another example, the length of the closure 68 in the longitudinal direction of the injection pen 1 is any value of 30-80% of the length of the auxiliary device 2, preferably 40-70% of the length of the auxiliary device 2. Can be taken.

The material of the closure 68 has a substantially uniform thickness. As described above, the outer surface of the closing portion 68, which is the surface farthest from the vertical axis of the injection pen 1 when the auxiliary device 2 is fitted to the injection pen 1, is substantially cylindrical, or at least a part of the cylinder. I take the.

The closure 68 includes two notches 72, 73. The cutouts 72, 73 extend from the edge of the closure 68 farthest from the axis 59 of the hinge formed on the other side of the auxiliary device 2. The notches 72 and 73 extend from this edge in a direction substantially circumferential with respect to the injection pen 1. The length of the notch is equal to about 1/6 or 1/5 of the circumference of the circle where the closure 68 is approximately located. The notches 72 and 73 define the tab 61. The tab 61 is connected to the main portion of the closing portion 68 at a position between the lowermost portions of the notches 72 and 73. The free end 63 of the tab 61 is located between the uppermost ends of the notches 72, 73. As most often seen in FIG. 9, the free end 63 of the tab 61 is curved to extend farther away from the vertical axis of the injection pen 1 at the central point between the notches 72, 73. This allows the user to better place his finger on the free end 63 of the tab 61 and pull the free end 63 in the lower left direction of FIG.

As is most often seen in FIGS. 9, 13, and 14, the inner surface of the tab 61 is provided with a hooking edge 64. The hooking edge portion 64 is provided at a joint portion between the hooking surface and another surface. The hook edge portion 64 extends by the width of the tab 61. As shown in FIG. 14, the hooking surface is a plane extending in a substantially radial direction with respect to the vertical axis of the injection device 1 when the closing portion 68 is in the closed position. At this position, the hook edge 64 is provided on the hook engagement surface 66 provided as part of the top of the auxiliary device 2, i.e., as part of the auxiliary device 2 that is not part of the closure 68. Engage. The hook engagement surface 66 is provided on a plane that is substantially in the same direction as the plane of the hook surface when the closing portion 68 is in the closed position.

When the user fits the auxiliary device 2 onto the injection pen 1, in particular the positioning rib 70 fits into the positioning channel 71 and the protrusions 53, 54 are located within the recesses 51, 52, the user fits the auxiliary device 2 Can be fixed to the injection pen 1. This is because the user moves the closure 68 from the position shown in FIG. 9, where the injection device receiving channel 58 is open and contains the injection pen 1, and the closure 68 is rotated around the hinge shaft 59 to tab 61. It is achieved by moving the free end 63 of the above toward the hooking engagement surface side. The movement is continued until the innermost part of the hooking edge portion 64 comes into contact with the guide surface 65 (as shown) located directly below the hooking engaging surface 66. The guide surface 65 is inclined in a substantially tangential direction with respect to the outer surface of the housing 10 of the injection pen 1.

At this point, the tendency of the closure 68 to adopt the shape shown in FIG. 13 provides a spring force between the end of the tab 61 and the guide surface 65. When the user exerts additional force on the closing portion 68, the closing portion 68 elastically deforms, increasing the separation between the free end 63 of the tab 61 and the hinge 59. As a result, the edge portion of the hooking edge portion 64 can slide on the guide surface 65. This continues until the hooking edge portion 64 is aligned with the edge portion between the guide surface 65 and the hooking engaging surface 66, and at the time of alignment, the hooking edge portion 64 and the hooking surface are aligned with each other. It engages in a channel formed on the hook engagement surface 66. At this point, the elasticity of the closure 68 causes the hook edge 64 and the hook engagement surface 66 to engage with each other, at which point the member is in the position shown in FIG. At this position, you will find that the innermost surface of the closure 68 is in close contact with the outermost surface of the housing 10 of the injection pen 1. At this point, the closure 68 ensures that the injection pen 1 is securely contained within the injection device receiving channel 58 and is held in place by the closure 68.

It will be appreciated that this arrangement prevents the injection device 1 from moving relative to the auxiliary device 2 in the plane of FIG.

The movement of the auxiliary device 2 along the vertical axis of the injection pen 1 is blocked by the fitting of the protrusions 53 and 54 with the recesses 51 and 52. In addition, the rightward movement of the auxiliary device 2 as shown in FIG. 8 is further prevented by the positioning rib 70 acting on the main body 20 of the auxiliary device 2.

Thus, in some embodiments, the auxiliary device 2 comprises one or more surfaces specifically configured to counteract the sliding of the auxiliary device 2 on the outer surface of the housing 10 of the injection device 1. In particular, as shown in FIG. 8, a high friction coating may be provided on the surface of the auxiliary device 2 that comes into contact with the injection device 1 when the auxiliary device 2 engages with the injection device 1, or the surface may have high friction. It may be formed from a material.

Such materials include rubberized materials, silicones, materials with rough surfaces, materials with some adhesiveness and the like. Such a surface may include one or more of the innermost surface of the closure 68 and / or the lowermost surface of the top of the auxiliary device. These surfaces can extend over the entire surface of the auxiliary device 2 that contacts the housing 10 of the injection device 1 during use, or can extend over only a portion of the associated surface.

To remove the auxiliary pen 2 from the injection pen 1, the user first places a finger, such as a thumb or other finger, on the top surface of the free end 63 of the tab 61. The user can then apply a force to the lower left side as shown in FIG. When the applied force is sufficient, the closing portion 68 is deformed to the point where the hooking edge portion 64 does not engage with the hooking engaging surface 66. At this point, the closure 68 can move downwards and swivel around the hinge shaft 59. In fact, when the injection device 1 is held in the orientation shown in FIG. 14, gravity aids the movement of the closure 68 in this direction. When the closure 68 swivels away from the injection device 1, the auxiliary device 2 is no longer fastened to the injection device 1. At this position, the auxiliary device 2 is held onto the injection device 1 only by fitting the protrusions 53, 54 and the recesses 51, 52.

In order to completely remove the auxiliary device 2, the user can grasp the auxiliary device 2 with one hand and apply an upward force to the auxiliary device 2 as shown in FIG. When the applied force is sufficient to overcome the spring and frictional forces, the sloping surfaces of the top recesses 51, 52 in FIG. 10 slide on the corresponding sloping surfaces of the protrusions 53, 54. .. When this occurs, the left and right arms 55, 56 separate against the urging of the spring 67. When the protrusions 53, 54 are released from the recesses 51, 52, the user receives a relatively small resistance when the auxiliary device 2 is removed from the injection device 1. Naturally, the cooperation between the positioning rib 70 and the positioning channel 71 does not prevent such separation between the auxiliary device 2 and the injection pen 1.

Alternatively, the user can grab the auxiliary device and move it to the right in FIG. In this case, the positioning ribs and the positioning channel 71 work together to help remove the protrusions from the recesses 51, 52. In particular, when the auxiliary device 2 begins to move slightly to the right with respect to the injection device 1, the positioning rib 70 slides deeper into the positioning channel, resulting in upward movement of the auxiliary device 2 with respect to the injection pen 1. The power of is applied. This upward force then helps overcome the spring and frictional forces required to remove the protrusions 53, 54 from the recesses 51, 52.

As seen in FIGS. 11a and 11b, the left and right arms 55, 56 are constrained on both sides by the body of the auxiliary device 2. This makes it possible to prevent or prevent the left and right arms 55 and 56 from moving in the direction perpendicular to the paper surface of FIG. This helps maintain the auxiliary device 2 in the correct position after attachment of the injection pen 1 even if there is a (weak) force acting to move the auxiliary device 2 along the vertical axis of the injection pen 1. .. The arms 55 and 56 can be called support members because they support the protrusions.

In some embodiments, the left and right arms 55, 56 move slightly freely in the direction perpendicular to the paper surface of FIG. In these embodiments, the body 20 of the auxiliary device 2 can move relative to the housing 10 of the injection pen 1, but the protrusions 53, 54 remain fully engaged in the recesses 51, 52. As a result, the engagement between the protrusions 53 and 54 and the recesses 51 and 52 is shown in FIG. 8 until at least the interaction between the positioning rib 70 and the positioning channel 71 causes the auxiliary device 2 to move upward with respect to the injection pen 1. It prevents the movement of the auxiliary device 2 to the right from being significantly restricted.

In some other embodiments, the left and right arms 55, 56 are configured to significantly resist movement in the direction perpendicular to the paper surface of FIG. In these embodiments, the arms 55, 56 can be provided with a triangular structure having protrusions at one corner and fixings of the auxiliary device 2 to the body at the other two corners. .. These two other corners can be separated by the axial length of the auxiliary device 2. The triangular structure may include three legs (limbs) or may be sheet-like. The triangular structure may be flat or curved.

In some embodiments, the positioning rib 70 and the positioning channel 71 are absent. In these embodiments, the correct alignment of the auxiliary device 2 with the injection pen 1 is provided by the fitting of the protrusions 53, 54 with the recesses 51, 52.

In some other embodiments, the right and left arms 55, 56 and protrusions 53, 54 are absent. In these embodiments, the correct alignment of the auxiliary device 2 and the injection pen 1 is provided by the positioning rib 70 and the positioning channel 71.

Of course, other alternative arrangements to ensure the correct relative position of the auxiliary device 2 and the injection pen 1 will be envisioned by those skilled in the art. All such alternative forms are within the scope of the invention, except as expressly excluded by the wording of the claims.

Those skilled in the art will also find that the auxiliary device 2 is fastened to the injection pen 1 once an alternative fixation arrangement, eg, the correct relative position, has been achieved. All such alternative forms are included within the scope of the invention, except as excluded by the wording of the claims. Such alternatives include various other hooking mechanisms, including elastic members such as tabs or arms, and do not include complex moving members. Other such embodiments involve more complex moving members such as clamps by twist lock mechanisms, tension clips, and other such mechanisms. Hinge is a relatively simple method of connecting the body of an auxiliary device having a closing member, but alternative coupling arrangements will be envisioned by those skilled in the art. Suitable connection arrangements can include sliding mechanisms, clips and the like.

Claims (24)

Auxiliary device for attachment to injection devices:
With an alignment arrangement to ensure a predetermined positional relationship between the auxiliary device and the injection device;
The auxiliary device comprising a fixed arrangement for fixing the auxiliary device to an injection device. The auxiliary device according to claim 1, wherein the aligned arrangement and the fixed arrangement are separate arrangements. The auxiliary device of claim 1 or 2, wherein the alignment arrangement comprises a positioning channel within the body of the auxiliary device, the positioning channel being configured to fit into a positioning rib on the injection device. The auxiliary device according to claim 3, wherein the positioning channel is located at one end of the main body of the auxiliary device. The alignment arrangement comprises first and second protrusions located on each of the first and second support members, the protrusions engaging the recesses of the injection device when the auxiliary device has a predetermined positional relationship. The auxiliary device according to any one of claims 1 to 4, which is configured as described above. The auxiliary device according to claim 5, wherein the auxiliary device has a body defining an injection device receiving channel, one protrusion is located on each side of the injection device receiving channel, and support members are urged toward each other. device. 6. The slope of the side of each protrusion closest to the bottom of the injection device receiving channel is greater than the slope of the side of the protrusion farthest from the bottom of the injection device receiving channel. Auxiliary device described. When the auxiliary device comprises an optical reading arrangement and there is a predetermined positional relationship between the auxiliary device and the injection device, the optical reading arrangement is directed to the display of the injection device and at least partially covers the display. The auxiliary device according to any one of claims 1 to 7. The one according to any one of claims 1 to 8, wherein the auxiliary device has a body defining an injection device receiving channel, and a fixed arrangement comprises a closure that is detachably attached across the injection device receiving channel. Auxiliary device. The auxiliary device of claim 9, wherein the fixed arrangement is movably attached to the body on the first side of the injection device receiving channel. The auxiliary device of claim 9, wherein the fixed arrangement is hinged to the body on the first side of the injection device receiving channel. The auxiliary device according to any one of claims 9 to 11, wherein the fixed arrangement is detachably connected to the main body of the auxiliary device by a hooking and fastening arrangement on the second side of the injection device receiving channel. A system comprising the auxiliary device according to any one of claims 1 to 12 and an injection device. 13. The thirteenth aspect, wherein the auxiliary device is located so as not to prevent the user from approaching the dose knob or injection button of the injection device when there is a predetermined positional relationship between the auxiliary device and the injection device. System. 13 or 14, claim 13 or 14, wherein the auxiliary device is located so as not to completely cover the drug information label provided on the injection device when there is a predetermined positional relationship between the auxiliary device and the injection device. System. The system of any one of claims 13-15, wherein the injection device comprises at least one protrusion that interacts with the alignment of the auxiliary device. 16. The system of claim 16, wherein at least one protrusion comprises a positioning rib. The system of any one of claims 13-17, wherein the injection device (1) comprises at least one recess that interacts with the alignment of the auxiliary device (2). Claim that the injection device (1) comprises a positioning rib (70) and two recesses (51, 52) that engage with each of the positioning channel (71) and protrusion (53, 54) of the auxiliary device (2). The system according to any one of 13 to 18. Use of at least one protrusion or at least one recess in the injection device to align or secure the auxiliary device onto the injection device by interacting with the alignment or fixation of the auxiliary device. Use of at least one protrusion or at least one recess in the injection device to align and secure the auxiliary device onto the injection device by interacting with the alignment or fixation of the auxiliary device. Use of at least one protrusion or at least one recess in the injection device to align and secure the auxiliary device onto the injection device by interacting with the alignment and fixation of the auxiliary device. The use according to any one of claims 20 to 22, wherein the protrusion is a positioning rib (70) that interacts with the positioning channel (71) of the auxiliary device (2). The use according to any one of claims 20-23, wherein the injection device comprises two recesses that interact with the two protrusions (53, 54) of the auxiliary device (2).

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