JP2020062481A - Pen-type injection device and electronic clip-on module therefor - Google Patents

Abstract

To provide an electronic clip-on module that measures information related to a state and/or a use status of an injection device, provides warning to a user if a measured value is out of a range of a normal operation state, and communicates data related to the measured value to an external device for further data processing.SOLUTION: A module includes a body and a fitting unit configured so as to releasably attach the body to an injection device at a specific position with respect to an external surface of the injection device.SELECTED DRAWING: Figure 2

Description

  The present invention relates to an apparatus for assisting a medical device configured to release a drug. In particular, the invention relates to an auxiliary device for a manually actuatable injection device.

  There are various diseases that require regular treatment by injection of drugs. Such injections can be performed by using an injection device, which injection device is applied by the healthcare professional or the patient himself. As an example, type 1 and type 2 diabetes can be treated by the patient himself, for example by injection of an insulin dose once or several times a day. For example, a prefilled, disposable insulin pen can be used as an injection device. Alternatively, a reusable pen can be used. Reusable pens allow the empty drug cartridge to be replaced with a new one. Both pens can be obtained with a set of disposable needles, which are replaced each time before use. The insulin dose to be injected can then be selected, for example manually, with the insulin pen by turning the dose knob and observing the actual dose from the insulin pen dose window or display. This dose is then injected by inserting the needle into the appropriate skin area and pressing the injection button on the insulin pen.

  To be able to monitor insulin injections, eg to prevent mishandling of insulin pens or to track doses already applied, eg information on the type and dose of insulin injected, etc. It is desirable to measure information relating to the condition and / or usage of the injection device. In this respect, US Pat. No. 6,037,058 discloses a medical device having a value sensor. A radio frequency identification (RFID) unit includes a value sensor, such as a pressure sensor, and is integrated with the liquid drug container to enable wireless monitoring of pressure or other drug-related parameter values. The liquid drug container is coupled to a first housing portion of the medical device, which first housing portion can, for example, comprise a prefilled, disposable injection device. The RFID unit is in wireless communication with a control circuit contained within a second housing portion of the medical device releasably attached to the first housing portion. The control circuit processes the value measured by the RFID unit, compares it with a pre-defined value, and alerts the user if the measured value is outside the normal operating range. And is adapted to communicate data associated with the measured value to an external device for further data processing.

  Therefore, although the control circuit of the medical device described in Patent Document 1 can be used with a series of prefilled disposable injection devices, an RFID unit having a value sensor is housed in the prefilled disposable injection device drug container. The requirement to be added greatly increases the cost of prefilled, disposable injection devices.

  For example, US Pat. No. 6,037,058 describes providing an auxiliary device with a mating unit for releasably attaching the device to an injection device. The device includes a camera to perform optical character recognition (OCR) on the captured image visible through the dose window of the injection pen, thereby determining the dose of drug dial-selected to the injection device. Is composed of.

WO2009 / 024562 WO2011 / 117212

  Therefore, it is an object of the present invention to provide, among other things, an auxiliary device for a manually actuatable injection device.

  According to a first aspect of embodiments of the present invention, there is provided an auxiliary device for a manually actuatable injection device, the auxiliary device comprising the body and the body in a specific position relative to the outer surface of the injection device. And a mating unit configured to releasably attach to the injection device. The mating unit can include a collar extending from the body configured to receive the injection device, such that the injection device extends through the collar.

  The mating unit may further comprise an engagement unit configured to engage the auxiliary device with the injection device.

  The engagement unit may further comprise a support member having an engagement element. The engagement element may be configured to engage within the recess on the injection device when the body is positioned in a unique position relative to the outer surface of the injection device.

  The support member may be a first support member, the engagement unit may further comprise a second support member, and an engagement element may be arranged at a free end of each support member. , The free ends of the support members can be biased towards each other.

  Each support member may be pivotally mounted within the body about an intermediate section and thus may urge the free ends of the support members away from each other to disengage the ridge from the recess. .

  The collar can include a closure movable toward the body to secure the body to the injection device.

  The closure may be rotatable towards the body to a fixed position, which acts on the support member to engage the engagement element when the closure is in the fixed position and thus the body is secured to the injection device. It can be configured to fit within the recess.

  The mating unit may further comprise a catch arrangement configured to releasably retain the closure in a fixed position.

  The body can have an injection device receiving channel, and the axis of rotation of the closure relative to the body can extend perpendicular to the longitudinal axis of the injection device receiving channel.

  The mating unit may further comprise a first locating surface and a second locating surface spaced from each other to receive the injection device therebetween. The collar is between a first position capable of slidably receiving the injection device therethrough and a fixed position in which the first locating surface and the second locating surface lie against an outer surface of the injection device. It can be configured to be swiveled by.

  The engagement unit may be configured to engage the injection device when the collar is pivoted into the fixed position.

  The second locating surface may be located between the first locating surface and the engagement unit.

  The mating unit may further include a locating recess in the body, the locating recess configured to mate with a locating rib on the injection device.

  The auxiliary device may further comprise an optical reading arrangement. The optical reading arrangement is directed to the display of the injection device when the body is attached to the injection device at a unique position relative to the outer surface of the injection device.

  According to another aspect of embodiments of the present invention, a kit is provided that includes an injection device and an auxiliary device.

  Embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings.

FIG. 6 is an exploded view of the injection device; FIG. 3a is a schematic view of an auxiliary device that is to be releasably attached to the injection device of FIG. 2b is a perspective view of the auxiliary device of FIG. 2a releasably attached to the injection device of FIG. Figures a and b are diagrams of possible functional distributions between devices when using an auxiliary device (such as the auxiliary device of Figures 2a and 2b) with an injection device. Figure 3 is a schematic view of the auxiliary device of Figure 2 attached to the injection device of Figure 1. 6 is a flow chart of a method used in various embodiments. 6 is a flowchart of a further method used in various embodiments. 6 is a flow chart of another method used in various embodiments. 1 is a schematic diagram of a tangible storage medium 60 according to one embodiment of the invention. FIG. 6 is an information sequence diagram showing a flow of information between various devices according to an embodiment of the present invention. 2b is a perspective view of the auxiliary device shown in FIG. 2b oriented for attachment to the injection device of FIG. 2b is a perspective view of the auxiliary device shown in FIG. 2b with the injection device of FIG. 1 received through the collar of the auxiliary device. 2b is a side view of the auxiliary device shown in FIG. 2b releasably attached to the injection device of FIG. 2B is a transverse rear view of the auxiliary device shown in FIG. 2b releasably attached to the injection device of FIG. 1 with the elastic arm of the locking unit in the engaged position relative to the injection device. 2B is a transverse rear view of the auxiliary device shown in FIG. 2b releasably attached to the injection device of FIG. 1 with the elastic arm of the locking unit in the disengaged position relative to the injection device. FIG. 9 is a perspective view of another embodiment of an auxiliary device releasably attached to the injection device of FIG. 1. 14 is a side view of the auxiliary device shown in FIG. 13 oriented to be attached to the injection device of FIG. FIG. 14 is a side view of the auxiliary device shown in FIG. 13 with the injection device of FIG. 1 received through the collar of the auxiliary device before the engagement unit engages the recess on the injection device. 14 is a side view of the auxiliary device shown in FIG. 13 with the injection device of FIG. 1 received through the collar of the auxiliary device and the engagement unit engaged in a recess on the injection device. FIG. 14 is a side view of the auxiliary device shown in FIG. 13 with the injection device of FIG. 1 received through the collar of the auxiliary device and the closure tightening the injection device. 14 is a schematic cross-sectional rear view of the auxiliary device shown in FIG. 13 releasably attached to the injection device of FIG. 1 with the closure in an unlocked position. 14 is a schematic transverse rear view of the auxiliary device shown in FIG. 13 releasably attached to the injection device of FIG. 1 with the closure in a partially locked position. 14 is a schematic transverse rear view of the auxiliary device shown in FIG. 13 releasably attached to the injection device of FIG. 1 with the closure in a fixed position.

  Hereinafter, an embodiment of the present invention will be described with reference to an insulin injection device. However, the invention is not limited to such fields of application and may be equally well deployed in other drug-releasing injection devices or other types of medical devices.

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

  The injection device 1 of FIG. 1 is a prefilled, disposable injection pen, which comprises a housing 10, contains an insulin container 14, in which the needle 15 can be attached. The needle is protected by an inner needle cap 16 and an outer needle cap 17, and then the inner needle cap 16 and the outer needle cap 17 can be covered by a cap 18. The insulin dose to be released from the injection device 1 can be selected by turning the dose knob 12, which is then selected via the dose window or display 13, for example the so-called International Unit (IU). Expressed as a multiple of 1 IU, is bioequivalent to approximately 45.5 micrograms of pure crystalline insulin (1/22 mg). An example of a selected dose displayed in the dose window or display 13 may be, for example, 30 IU, as shown in FIG. It should be noted that the selected dose may likewise be displayed in different ways, for example by an electronic display. It will be appreciated that the dose window relates to the section of the injection device through which the selected dose can be viewed.

  Turning the dose knob 12 produces a mechanical clicking sound, providing audible feedback to the user. The numbers displayed in the dose window or display 13 are printed on a sleeve housed within the housing 10, which sleeve mechanically interacts with a piston within the insulin container 14. When the needle 15 is pierced into the skin part of the patient and then the injection button 11 is pressed, the insulin dose displayed in the display 13 is released from the injection device 1. When the needle 15 of the injection device 1 remains in the skin area for a certain time after the injection button 11 is pressed, the majority of the dose is actually injected into the patient's body. The release of the insulin dose also produces a mechanical clicking sound, which is different from the sound that occurs when using the dose knob 12.

The injection device 1 can be used for multiple injection treatments until the insulin container 14 is empty or the expiration date of the injection device 1 is reached (e.g. 28 days after first use).

  Furthermore, before using the injection device 1 for the first time, in order to remove air from the insulin container 14 and the needle 15, for example, 2 units of insulin are selected, and the injection is performed while holding the injection device 1 with the needle 15 facing upward. By pressing the button 11, it may be necessary to perform a so-called "prime shot".

  For the sake of simplicity, in the following, the dose to be released corresponds substantially to the dose to be injected, so that, for example, when proposing a dose to be injected next, this dose must be released by the injection device. It is illustratively assumed to be equal to the dose that does not occur. Nevertheless, it is of course also possible to take into account the difference (eg loss) between the dose released and the dose injected.

  The housing 10 of the injection device 1 comprises a front section 101 and a rear section 102. The needle 15 is attached to the front end of the front section 101 and the dose knob 12 extends from the rear end of the rear section 102. In the front section 101, the diameter of the rear section 102 of the housing 10 of the injection device is smaller. A shoulder 103 is defined between the front section 101 and the rear section 102. The shoulder 103 extends circumferentially around the housing 10.

  The cap 18 extends above the front section 101. The cap 18 covers the front section 101, and the edge 18 a of the cap 18 is positioned in contact with the shoulder 103.

  A cap holding ridge 104 is formed on the outer surface of the front section 101 of the housing 10 of the injection device 1. The cap holding ridge 104 is arranged in the vicinity of the shoulder 103, but is separated from the shoulder 103. The ridges 104 extend diametrically around the front section 101. The ridges 104 overlie one or more retaining elements (not shown) formed on the inner surface of the cap 18 to retain the cap 18 in place on the front section 101. . Alternatively, the cap retaining ridges 104 are located in corresponding diametrically extending recesses (not shown) formed on the inner surface of the cap 18.

  The injection device 1 further comprises additional elements. A rib 105 projects from the outer surface 106 of the injection device 1. The rib 105 acts as an alignment element that positions the body in a unique position relative to the outer surface 106 of the injection device 1. The rib 105 stands upright from the outer surface 106 of the injection device 1 between the dose window 13 and the dose knob 12. The dose knob 12 is located on the rear section 102 of the housing 10 of the injection device. The rib 105 is elongated and extends parallel to the longitudinal axis of the injection device 1.

  Left and right depressions 107 (see FIG. 8) are formed in the outer surface 106 of the injection device 1. Two depressions 107 are formed in the rear section 102. Each recess 107 is formed near the rear end of the housing 10 of the injection device. These recesses 107 are formed on the left and right sides of the injection device 1, generally diametrically opposite one another. These depressions 107 have chamfered side surfaces.

2a is a schematic view of an embodiment of an auxiliary device 2 intended to be releasably attached to the injection device 1 of FIG. The auxiliary device 2 comprises a housing 20 and has a mating unit configured to surround the housing 10 of the injection device 1 of FIG. 1, so that the auxiliary device 2 is tightly located on the housing 10 of the injection device 1. However, it is nevertheless removable from the injection device 1, for example when the injection device 1 is empty and has to be replaced. FIG. 2a is very schematic and details of the physical arrangement will be described later with reference to FIG. 2b.

  The auxiliary device 2 houses light and acoustic sensors for collecting information from the injection device 1. At least some of this information, for example the selected dose (and optionally the unit of this dose), is displayed via the display unit 21 of the auxiliary device 2. The dose window 13 of the injection device 1 is blocked by the auxiliary device 2 when attached to the injection device 1.

  The auxiliary device 2 further comprises three user input converters. These transducers are shown schematically as buttons 22. These input converters 22 allow the user to power on / off the auxiliary device 2, trigger actions (eg, establish a connection or pairing with another device and / or separate from the auxiliary device 2). To trigger the transmission of information to the device) or something.

  FIG. 2b shows a view of the auxiliary device 2 in which the arrangement of the mating unit and the housing is shown in more detail. In FIG. 2 b, the auxiliary device 2 is shown attached to the injection device 1.

  The housing 20 of the auxiliary device 2 has a body 300 and a collar 301. The main body 300 is elongated and the display unit 21 is arranged on the upper surface 302 of the main body 300. The collar 301 extends from the lower surface 303 of the body 300. The body 300 has a front end 304 and a rear end 305. The collar 301 extends from the front end 304. Collar 301 extends from body 300 at an acute angle to the longitudinal axis of elongated body 300.

  An opening 306 is formed through the collar 301. The collar 301 is configured to receive the injection device 1 through the opening 306. A channel 307 (see FIG. 11) is formed in the lower surface 303 of the main body 300. The channel 307 is elongated and extends between the front end 304 and the rear end 305 of the body 300.

  Two wings 308, which act as protective walls, extend downwardly from the lower surface 303 of the body 300. Wings 308 are spaced from each other and extend from opposite sides of channel 307. Therefore, the injection device 1 can be received between the wings 308. The wing 308 is disposed at the rear end 305 of the main body 300 at the end of the main body 300 opposite to the collar 301.

  The collar 301 and the channel 307 form part of an alignment arrangement or alignment unit. The alignment unit is configured to position the body in a unique position with respect to the outer surface 106 of the injection device 1. The alignment unit forms part of a mating unit configured to surround the housing 10 of the injection device 1 to maintain the auxiliary device in a unique position on the injection device 1.

  The auxiliary device 2 further comprises an engagement unit or arrangement configured to releasably attach the body to the injection device 1. The collar 301 also forms part of the engagement unit. The engagement unit forms part of the fitting unit.

  The features that contribute to the correct alignment of the auxiliary device 2 on the injection device 1 can be referred to as the alignment arrangement or alignment unit. The feature that contributes to the engagement of the auxiliary device 2 with the injection device 1 can be referred to as an engagement unit or engagement arrangement.

  Figures 3a and 3b show possible functional distributions between devices when using an auxiliary device (such as the auxiliary device of Figures 2a and 2b) with an injection device.

  In set 4 of Figure 3a, an auxiliary device 41 (such as those of Figures 2a and 2b) determines information from the injection device 40 and provides this information (eg, the type and / or dose of the drug to be injected). To the blood glucose monitoring system 42 (eg, via a wired or wireless connection).

  The blood glucose monitoring system 42 (which can be implemented, for example, as a desktop computer, personal digital assistant, cell phone, tablet computer, notebook, netbook, or ultrabook) is designed to By recording (for example, by assuming the emitted dose and the injected dose are the same, or by determining the injected dose based on the released dose, eg , Based on the dose released by assuming that the pre-defined percentage is not completely received by the patient). Blood glucose monitoring system 42 may, for example, suggest the type and / or dose of insulin for the next injection for this patient. This offer is information regarding one or more past injections received by the patient, and is currently provided by blood glucose meter 43 to blood glucose monitoring system 42 (eg, via a wired or wireless connection). Can be done based on information about blood glucose levels of. Thus, the blood glucose meter 43 may be implemented as a separate device configured to receive a small blood probe of the patient (eg, on a carrier material) and determine the blood glucose level of the patient based on the blood probe. it can. However, the blood glucose meter 43 can also be a device that is implanted at least temporarily into the patient, for example in the patient's eyes or under the skin.

  Figure 3b is a modified set 4 ', the blood glucose meter 43 of Figure 3a being included within the blood glucose monitoring system 42 of Figure 3a, thus resulting in the modified blood glucose monitoring system 42' of Figure 3b. . The functionality of the injection device 40 and the auxiliary device 41 of Figure 3a is not affected by this modification. Also, the functionality of blood glucose monitoring system 42 and blood glucose meter 43, combined as blood glucose monitoring system 42 ', is essentially unchanged except that they are configured in the same device, and thus It eliminates the need for wired or wireless external communication between devices. However, within system 42 ', there is communication between blood glucose monitoring system 42 and blood glucose meter 43.

  FIG. 4 shows a schematic view of the auxiliary device 2 of FIG. 2a in the mounted state on the injection device 1 of FIG.

  The housing 20 of the auxiliary device 2 comprises several components. These components are controlled by the processor 24. The processor 24 can be, for example, a microprocessor, digital signal processor (DSP), application specific integrated circuit (ASIC), field programmable gate array (FPGA), or the like. 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. Also, the main memory 241 can be used to store a logbook regarding the delivered / injected injections. Program memory 240 can be, for example, read only memory (ROM) and main memory can be, for example, random access memory (RAM).

In the exemplary embodiment, the processor 24 can interact with the first button 22 via which the auxiliary device 2, for example, can be powered on and off. The second button 33 is a communication button. The second button can be used to trigger the establishment of a connection to another device or the transmission of information to another device. The 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. The buttons 22, 33, 34 can be any suitable form of user input transducer, such as a mechanical switch, capacitive sensor, or other touch sensor.

  The processor 24 controls the display unit 21, which is embodied here as a liquid crystal display (LCD). The display unit 21 is used, for example, to display to the user of the auxiliary device 2 information about the current setting of the injection device 1 or the next injection to be given. The display unit 21 can also be implemented as a touch screen display, for example to receive user input.

  The processor 24 also controls a light sensor 25, which may be implemented as an optical character recognition (OCR) reader and capture an image of the dose display 13 displaying the currently selected dose. It is possible (using numbers printed on the sleeve 19 housed in the injection device 1, these numbers being visible through the dose display 13). It is further possible that the OCR reader 25 recognizes characters (eg numbers) from the captured image and provides this information to the processor 24. Alternatively, the unit 25 in the auxiliary device 2 can be a simple optical sensor, such as a camera, for capturing an image and providing information about the captured image to the processor 24. Processor 24 is then responsible for performing OCR on the captured image.

  The processor 24 also controls a light source, such as a light emitting diode (LED) 29, to illuminate the dose display 13 which displays the currently selected dose. In front of the light source, a diffuser plate can be used, for example a diffuser plate made from a piece of acrylic glass. Further, the optical sensor can include a lens (eg, an aspherical lens) that provides a magnification (eg, a 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. This optical property may only be present in a unique part of the housing 10, for example the color or color coding of the insulin container contained in the sleeve 19 or the injection device 1, which color or color coding is for example , Through an opening or window in housing 10 (and / or sleeve 19). Information about this color is then provided to the processor 24, which can then determine the type of injection device 1 or the type of insulin contained within the injection device 1 (eg, Solostar Lantus is purple. , And Solostar Apidra has a blue color). Alternatively, a camera unit can be used in place of the photometer 26, which then provides an image of the housing, sleeve, or insulin container to the processor 24 and image processing is used to provide the housing, sleeve, or insulin container. The color of can be determined. Further, one or more light sources may be provided to improve the reading of the photometer 26. The light source can provide light of a particular wavelength or spectrum to improve color detection by the photometer 26. The light sources can be arranged, for example, such that unwanted reflections by the dose display 13 are avoided or reduced. In an exemplary embodiment, instead of, or in addition to, the photometer 26, a camera unit may be located to code associated with the injection device and / or the medication contained within the injection device (eg, Bar codes, which can be, for example, one-dimensional or two-dimensional bar codes) can be detected. This code can be positioned, for example, on the housing 10 or on a drug container contained within the injection device 1, to name a few. This code can indicate, for example, the type of injection device and / or medication, and / or additional characteristics (eg, expiration date).

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

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

  The processor 24 controls a wireless unit 28 that is configured to wirelessly transmit and / or receive information with another device. Such transmission may be based on, for example, wireless or optical transmission. In some embodiments, the wireless unit 28 is a Bluetooth transceiver. Alternatively, the wireless unit 28 may be replaced or supplemented by a wired unit configured to hardwire and / or receive information to / from another device, eg, via a cable or fiber connection. it can. When data is transmitted, the unit of data (value) to be transmitted can be explicitly or implicitly defined. For example, for insulin doses, International Units (IU) may always be used, or otherwise the units used may be explicitly conveyed, eg, in a coded manner.

  The processor 24 receives input from a pen detection switch 30 operable to detect whether the pen 1 is present, i.e. whether the auxiliary device 2 is coupled to the injection device 1.

  A battery 32 uses a power supply 31 to power the processor 24 and other components.

  Therefore, the auxiliary device 2 of FIG. 4 is able to determine information related to the condition and / or usage of the injection device 1. This information is displayed on the display 21 for use by the device user. This information can 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 flow charts of an embodiment 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), but can also be performed by the processor of the auxiliary device 2 of FIG. It can be stored in the program memory 240. Program memory 240 may take the form of tangible storage medium 60 of FIG. 6, for example.

  FIG. 5a shows the steps of the method carried out in the scenario shown in FIGS. 3a and 3b, wherein the information read by the auxiliary device 41 from the injection device 40 is provided to the blood glucose monitoring system 42 or 42 '. It will not receive any more information from the monitoring system 42 or 42 '.

  Flowchart 500 begins, for example, when an auxiliary device is powered on or otherwise activated. At step 501, the type of medication, eg insulin, provided by the injection device is determined, eg based on color recognition, or based on the recognition of a code printed on the injection device or a component thereof already described above. . If the patient always takes the same type of drug and uses only the injection device with this single type of drug, detection of the drug type may not be necessary. Further, determination of drug type may be assured in other ways (eg, the key-recess pair shown in FIG. 4 allows the auxiliary device to be used with only one unique injection device, then Only this single type of drug can be provided).

  At step 502, the currently selected dose is determined, for example, by OCR of the information shown above the dose window of the injection device. This information is then displayed to the user of the injection device at step 503.

  In step 504, it is confirmed whether the emission has taken place, for example by the above-mentioned sound recognition. Thereupon, on the basis of the different sounds produced by the injection device and / or on the dose emitted (eg a smaller dose, eg a unit smaller than a pre-defined amount, eg 4 or 3 units, Prime shots can be regarded as belonging to a larger shot, whereas larger doses are considered to belong to an actual injection), prime shots and actual injections (in vivo) can be distinguished.

  If a release has taken place, the determined data, i.e. the selected dose and the type of drug (e.g. insulin) (if applicable), is stored in main memory 241, which is later stored in main memory 241. From another device, such as a blood glucose monitoring system. If a distinction is made regarding the nature of the release, for example whether the release was performed as a prime shot or an actual injection, this information can also be stored in the main memory 241, and in some cases also. It can be transmitted later. If an injection has been performed, then in step 505 the dose is displayed on the display 21. Also, the time since the last injection is displayed, which is 0 minutes or 1 minute immediately after the injection. The time since the last dose can be displayed intermittently. For example, this time can be displayed alternately with the name of the injected drug or other identifying information, eg, Epidra or Lantus.

  If no release was performed in step 504, steps 502 and 503 are repeated.

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

  FIG. 5c shows in more detail the steps of an exemplary method performed when a selected dose is determined based on the use of light sensors alone. For example, these steps can be performed at step 502 of Figure 5a.

At step 901, a sub-image is captured by a photosensor, such as photosensor 25 of auxiliary device 2. The captured sub-image is, for example, an image of at least a portion of the dose window 13 of the injection device 1, in which the currently selected dose is displayed (eg through the dose window 13). With the numbers and / or scale printed on the sleeve 19 of the injection device 1 which is visible). For example, the captured sub-image may have a low resolution and / or may only show the portion of the sleeve 19 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 visible through the dose window 13. After capturing the image, the image is further processed, for example, as follows:
Segmentation by pre-captured background image;
Image binning to reduce the number of pixels for further evaluation;
Image normalization to reduce variations in illumination intensity;
Image shearing; and / or image binarization by comparison with a fixed threshold.

  Some or all of these steps can be omitted if applicable, eg, if a sufficiently large photosensor (eg, a sensor having sufficiently large pixels) is used.

  At step 902, it is determined whether there is a change in the captured sub-image. For example, the currently captured sub-image can be compared to the previously captured sub-image to determine if there is any change. Then, the comparison with the pre-captured sub-image is made by comparing the pre-captured sub-image just before the current sub-image is captured and / or the pre-captured sub-image. Of the sub-images captured within a specified time period (eg, 0.1 seconds) before the current sub-image was captured. This comparison can be based on image analysis techniques such as pattern recognition performed on the currently captured sub-image and the previously captured sub-image. For example, it may be possible to analyze whether the scale and / or pattern of numbers visible through the dose window 13 and shown in the currently captured sub-image and the previously captured sub-image has changed. it can. For example, it is possible to search the image for patterns having particular dimensions and / or aspect ratios and to compare these patterns with previously stored patterns. Steps 901 and 902 can correspond to detecting changes in the captured image.

  If step 902 determines that the sub-image has changed, step 901 is repeated. Otherwise, at step 903, an image is captured by a light sensor, such as light sensor 25 of auxiliary device 2. The captured image is, for example, an image of the dose window 13 of the injection device 1 in which the currently selected dose is displayed (eg the injections visible through the dose window 13). (Using numbers and / or scale printed on sleeve 19 of device 1). 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 visible through the dose window 13.

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

At step 905, it is determined if there is a change in the determined selected dose, and if the optionally determined selected dose is not equal to zero. For example, comparing the currently determined selected dose with the previously determined selected dose,
It can be determined whether there is a change. So, the comparison with the pre-determined selected dose is the pre-determined selection that was determined within the specified time period (eg 3 seconds) before the currently selected dose was determined. It can be limited to the dose (s) being given. If there is no change in the determined selected dose, and in some cases the determined selected dose is not equal to zero, the currently determined selected dose is for further processing (eg, Returned / Sent to processor 24).

  Therefore, if the last rotation of the dose knob 12 was made before 3 seconds, the selected dose is determined. If the dose knob 12 is turned within 3 seconds and the new position has not changed for more than 3 seconds, this value is considered the determined selected dose.

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

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

  At step 1002, it is determined whether the captured sound is a click sound. The sounds that are captured are, for example, when the dose is dial-selected by turning 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 It can be a click sound that occurs when a prime shot is performed. If the captured sound is not a click, step 1001 is repeated. Otherwise, at step 1003, an image is captured by a light sensor, such as light sensor 25 of auxiliary device 2. Step 1003 corresponds to step 903 of flowchart 900.

  At step 1004, OCR is performed on the image captured at step 1003. Step 1004 corresponds to step 904 of flowchart 900.

  At step 1005, it is determined if there is a change in the determined selected dose, and if the optionally determined selected dose is not equal to zero. Step 1005 corresponds to step 905 of flowchart 900.

  Regarding the power consumption of the auxiliary device, the acoustic approach shown in Figure 5c may have a slight advantage. This is because typically permanently capturing an image or sub-image as shown in Figure 5b consumes more power than listening to an acoustic sensor such as a microphone.

  FIG. 6 is a schematic diagram of a tangible storage medium 60 (computer program product) comprising a computer program 61 with program code 62 according to aspects of the present invention. This program code can be executed, for example, by a processor housed in the auxiliary device, for example the processor 24 of the auxiliary device 2 of Figures 2a and 4. For example, storage medium 60 may represent program memory 240 of auxiliary device 2 of FIG. The storage medium 60 can be a fixed memory or a removable memory such as a memory stick or a card.

Finally, FIG. 7 is an information sequence chart illustrating the flow of information between various devices (eg, injection device 1 and auxiliary device 2 of FIG. 4 in the scenario shown in FIG. 3a or 3b) according to one embodiment of the present invention. 7 The condition and / or usage of the injection device 70 affects the appearance of its dose window, the sound produced by the injection device 70, and the color of the housing. This information is converted by the sensor 710 of the auxiliary device 71 into an OCR signal, an acoustic sensor signal, and a photometer signal, respectively, which signals are then respectively dialed by the processor 711 of the auxiliary device 71 for the dial-selected dose, It is converted into information regarding the injection / dial selection operation and the type of insulin. This information is then provided by auxiliary device 71 to blood glucose monitoring system 73. Some or all of this information is displayed to user 72 via display 21.

  As described in detail above, embodiments of the present invention enable useful and productive connection of standard injection devices, specifically insulin devices, with blood glucose monitoring systems.

  In embodiments of the present invention, assuming that the blood glucose monitoring system has wireless or other communication characteristics, an auxiliary device is installed to allow this connection.

  The benefits gained from the connection between the blood glucose monitoring system and the insulin injection device are, inter alia, a reduction in mistakes by the user of the injection device and a reduction in the handling process, which can be used for blood glucose monitoring, specifically for the last time injected. Eliminates the need to manually transfer the injected insulin unit to a blood glucose monitoring system that has the functionality to provide guidance for the next dose based on the dose and recent blood glucose levels.

  As described with reference to the exemplary embodiments above, when the user / patient obtains a new insulin pen, the user can use the mating unit to create a new pen, as described in detail below. Attach the auxiliary device to. The auxiliary device reads the injected dose. The auxiliary device can also deliver the injected dose to a blood glucose monitoring system with insulin titration capabilities. For patients who take multiple insulins, the auxiliary device can recognize the device structure for the type of insulin and also transmit this information to the blood glucose monitoring system.

  The mating unit for releasably attaching the auxiliary device to the injection device at a specific position relative to the outer surface of the injection device will now be described in detail.

  The 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. Accurate alignment allows accurate movement and reliable reading. Ensuring accurate alignment between the auxiliary device 2 and the injection device 1 in use allows for a simpler design for the OCR reader 25. This is because the OCR reader 25 does not have to be specifically designed to accommodate different alignment between the devices 1 and 2.

  Referring to FIG. 8, the auxiliary device 2 is shown before mounting the auxiliary device 2 on the injection device 1. In FIG. 8 the auxiliary device 2 is shown directed towards the rear section 102 of the housing 10 of the injection device 1 so that the rear section 102 can be received through the opening 306 formed in the collar 301. ing.

  The housing 20 of the auxiliary device 2 comprises a body 300 and a collar 301. The elongated body 300 has a longitudinal axis and the collar 301 extends downwardly from the front end 304 of the body 300.

A channel 307 (see FIGS. 10 and 11) formed in the lower surface 303 of the body 300 extends from an opening 306 formed in the collar 301. Thus, the upper portion of opening 306 forms part of an elongated channel extending between the front and rear ends of housing 20.

  The opening 306 has a front opening 309. The front opening 309 is formed in the front surface 310 of the housing 20. The front surface 310 can be flat. The edges of the front opening 309 are defined on a plane that extends at an angle to the longitudinal axis of the elongated body 300. The front opening 309 has an oval shape. The width of the front opening 309 in the minor axis or conjugate diameter corresponds to or is slightly larger than the diameter of the rear section 102 of the injection device 1. The width of the front opening 309 in the major axis or lateral diameter is larger than the diameter of the rear section 102 of the injection device 1. It will be appreciated that the rear section 102 of the injection device 1 can be received through the opening 309 and thus the rear section 102 extends through the opening 306.

  Channel 307 is shown in FIGS. The channel 307 has a base 312. The base 312 of the channel 307 is arcuate in cross section. The base 312 extends parallel to the longitudinal axis of the body 300. The shape of the base 312 corresponds to the outer surface of the rear section 102 of the injection device 1. Thus, the rear section 102 of the injection device can be received in the base 312, the outer surface of the injection device 1 being located in contact with the channel base 312. An optical sensor 25 is embedded in the channel base 312 and faces the channel 307.

  The collar 301 defines an upper portion 314 and a lower portion 315. The upper portion 314 is integrally formed with the body 300 and thus extends from the base 312 of the channel 307. The lower portion 315 faces the upper portion 314, but is at least partially offset from the upper portion 314. In this embodiment, the upper portion 314 is defined by the upper half of the inner surface of the collar 301 and the lower portion 315 is defined by the lower half of the inner surface of the collar 301. The inner surface of the collar 301 defines a cylinder and the base 312 of the channel 307 extends from the cylindrical surface. Thus, the arcuate base of channel 307 and the cylindrical inner surface of the collar are shaped to arc about the same longitudinal axis.

  A lower positioning surface 317 is defined on the lower portion 315 of the collar 301. An upper positioning surface 316 is defined on the upper portion 314 of the collar 301. The upper locating surface and the lower locating surface face each other. The upper locating surface 316 and the lower locating surface 317 are configured to lie against the outer surface of the injection device 1 when the injection device is received through the opening. By rotating the auxiliary device 2 about an axis extending orthogonal to the long axis of the opening 309, the positioning surfaces 316, 317 contact the injection device 1 and thus the upper and lower positioning surfaces are Moved towards the outer surface of. The central axis of the cylindrical opening extending through the collar is aligned with the longitudinal axis of the injection device 1.

  In this embodiment, the channel base 312 extends flush with the upper portion of the collar 301. Thus, when the auxiliary device 2 is rotated about an axis extending orthogonal to the long axis of the opening 309, so that the upper and lower locating surfaces are moved into contact with the outer surface of the injection device 1. , The base 312 of the channel is also located on the outer surface of the injection device 1. Thus, it will be appreciated that the upper locating surface may be formed by the upper portion of the collar or the base 312 of the channel 307. Alternatively, the lower locating surface is formed on one or more locating elements that project into the opening from the lower portion of the collar. Similarly, the upper locating surface is formed on one or more locating elements that project into the opening or injection device receiving channel.

In the base 312 of the channel 307, a rib receiving recess.
process) 318 (see FIGS. 11 and 12) is formed. The rib receiving recess 318 is sized to receive the rib 105 protruding from the outer surface 106 of the injection device 1. The rib receiving recess 318 is sized to closely correspond to the shape and size of the positioning rib 105 present on the injection pen 1. The rib receiving recess 318 is slightly larger than the positioning rib 105, so that the positioning rib 105 can be reliably and easily positioned in the recess. Thus, the rib 105 acts as an alignment element that positions the body in a unique position relative to the outer surface 106 of the injection device 1 when the rib 105 is received within the rib receiving recess 318. Thus, the rib receiving recess 318 aids in accurate alignment and orientation of the body 300 on the injection device 1.

  The rib receiving recess 318 is formed at the end of the auxiliary device 2 that is closest to the dose knob 12 when the auxiliary device 2 is housed in the injection device 1.

  Under the injection device receiving channel 307, left and right sides of the body 300 extend to the left and right arms 320, which act as support members. As shown in FIGS. 11 and 12, the lower portion 324 of each arm 320 hangs substantially vertically from the lower surface of the body 300 of the auxiliary device 2. Thus, the arms 320 extend on opposite sides of the injection device receiving channel 307 and are spaced apart from each other.

  The left arm 320 has a left ridge 322 located at the free end 321 of the lower portion 324. The right arm 320 also has a right ridge 322 located at the free end 321 of the lower portion 324. Each ridge 322 acts as an engagement element and engages in a recess 107 formed in the outer surface of the rear section 102 of the injection device 1. The ridge 322 on the left arm 320 is configured to be received within the left depression 107. The ridge 322 on the right arm 320 is configured to be received within the right depression 107. The ridges 322 each have a shape corresponding to the shape of the depression 107. In this way, the ridges 322 fit within their respective depressions 107 when the auxiliary device 2 is correctly positioned on the injection device 1. The outer dimensions of the ridges 322 are slightly smaller than the inner dimensions of the depressions 107, thus ensuring that the ridges 322 fit within their respective depressions.

  In this embodiment, the right ridge 322 is shaped to closely correspond to the shape of the right depression 107. In this way, when the auxiliary device 2 is correctly positioned on the injection pen 1, the right ridge 322 fits snugly within the right depression 107. The left ridge 322 is similar in shape to the right ridge 322, but not very high. In other words, the left ridge 322 is like the right ridge 322, but the top portion is missing or cut. This is why the end surface of the left ridge 322 has a larger area than the right ridge 322. Using different dimensions for the ridges 322 helps the ridges to find engagement within the depression 107. The right ridge 322 can be considered the master for the left ridge 322, and the left ridge 322 is a slave.

  Each arm 320 has an upper portion 323 and a lower portion 324. A step 325 is formed in the middle section of each arm 320, the upper portion 323 hangs from one side of the step 325, and the lower portion 324 hangs from the other side. The ridge 322 is formed at the free end of the lower portion 324. The lower portion 324 extends from the step 325 at an angle to the upper portion 323.

A support element 326 is arranged on the left side of the body 300. Another support element 326 is arranged on the right side of the body 300. Each support element 326 is disposed within the body 300 and is spaced from the outer shell 327 of the body 300 to define a gap. The left arm 320 is received on the left side of the body 300. The right arm 320 is received on the right side of the body 300. Arm 320 is located behind wing 308 that hangs from body 300. The wings 308 can be formed from a transparent material. This allows the user to see the location of the arm 320 relative to the depression 107, which can help the user to accurately position the auxiliary device 2 on the injection device 1. As can be seen in FIG. 11, the wing or protective wall 308 extends slightly further downward than the arm. The left arm 320 extends through a gap formed in the left side of the body 300 and the right arm 320 extends through a right gap of the body 300. The step 325 formed in the middle section of each arm 320 lies against the corresponding support element 326. Step 325 positions each arm 320 such that the lower portion 324 extends below the support element 326. The end of the upper portion 323 of each arm 320 lies against a tab 328 extending from the inner surface of the body outer shell 327. Thus, the upper portion 323 of each arm 320 is held in place within the body 300 and extends between the support element 326 and the tab 328.

  The distance between each support element 326 and tab 328 is slightly less than the length of the upper portion 323 of each arm 320. Thus, when the upper portion 323 of each arm 320 is positioned between the corresponding element 326 and the tab 328, the upper portion 323 of each arm 320 is deformed to have an arcuate shape. Each arm 320 has elasticity. The upper portion 323 curves towards the outer shell of the body 300 to form a convex shape. Therefore, step 325 is biased against support element 326 and the free end of upper portion 323 is biased against tab 328. The upper portion 323 of each arm 320 between the free end and the step is moved towards the outer shell 327.

  The lower portion 324 of each arm 320 extends from the upper portion 323 through a gap defined between the support element 326 and the outer shell 327. The lower portions 324 of the arms 320 are flared towards each other and extend from the support element 326. The elastic effect of the upper portion 323 of each arm 320 is to bias the lower portion 324 of each arm 320 to a particular position. The initial position of the lower portion 324 of each arm 320 is such that the distance between the innermost surfaces of the ridges 322 is slightly less than the distance between the bottoms of the depressions 107. The biasing effect of each arm 320 is to resist movement of the ridge 322 and the lower portion 324 of the arm 320 away from each other.

  Arm 320, which acts as a support member, is stationary in a direction along the longitudinal axis of elongated body 300. This keeps the auxiliary device 2 in the correct location after engagement of the auxiliary device on the injection pen 1 even in the presence of forces acting to move the auxiliary device 2 along the longitudinal axis of the injection pen 1. To help. The arm 320 supports the ridge and thus can be referred to as a support member.

  Left and right buttons 330 are attached to the left and right sides of the main body 300. Openings 331 are formed through the outer shell 327 on both sides of the body 300. A protrusion is formed on the rear surface of each button 330, which acts as an actuating element 332, extends through a corresponding opening 331 and acts on the upper portion 323 of the corresponding arm 320 to exert a biasing force on the upper portion 323.

When one of the buttons 330 is pushed inward by the user, the actuating element 332 of each button 330 is biased inward. The actuating element 332 presses the convex surface of the upper part 323 of the corresponding arm 320. The upper portion 323 then deforms under the force applied by the actuating element 332. The support element 324 acts as a fulcrum and the arm 320 is pivoted about the support element. The distal end of the upper portion 323 is immobilized by the upper portion 323 located against the tab 328. However, the free end 321 of the lower portion 324 is free to move outwards, so that the lower portion 324 is supported by the support element 32.
Turn around 4.

  When both buttons are pressed, the lower portions 324 of the two arms 320 are rotated around their respective support elements 324. Therefore, the free ends 321 of the arm lower portions 324 are moved away from each other. When the push on each button is released, the biasing force acting on the upper portion 323 of each arm is also released, thus the lower portion of each arm is returned to the neutral position due to the elasticity of arm 320.

  As shown in FIG. 8, the auxiliary device 2 is initially positioned with respect to the injection pen 1 such that the opening 309 for the opening 306 in the collar 301 is aligned with the rear end of the injection device 1. The body 300 is oriented such that the longitudinal axis of the injection device receiving channel 307 is inclined with respect to the longitudinal axis of the injection device 1.

  The collar 301 is then slid over the posterior section 102 of the injection device 1, as shown in FIG. The width of the front opening 309 in the minor axis or conjugate diameter corresponds to or is slightly larger than the diameter of the rear section 102 of the injection device 1. The width of the front opening 309 in the major axis or lateral diameter is larger than the diameter of the rear section 102 of the injection device 1. Therefore, the rear section 102 of the injection device 1 is received through the opening 306 of the collar 301.

  To position the auxiliary device 2 on the injection device 1, the auxiliary device 2 is rotated with respect to the injection device 1 about an axis extending orthogonal to the long axis of the opening 309. The longitudinal axes of the injection device 1 and the injection device receiving channel 307 are rotated towards each other. Moreover, the upper and lower locating surfaces 316 and 317 are moved towards the outer surface of the injection device 1.

  When the auxiliary device 2 and the injection device 1 are rotated with respect to each other, the free ends 321 of the left and right arms 320, in particular the ridges 322, come into contact with the outer surface of the injection device housing 10. The ridges 322 now bring the housing into contact with the left and right sides of the display window 13.

  To engage the auxiliary device 2 with the injection device 1, the user first positions the auxiliary device 2 relative to the injection device 1 as shown in FIG. 9, and then applies a further downward force on the auxiliary device 2, At the same time, an upward force is applied to the injection device 1. Therefore, the auxiliary device 2 and the injection device are rotated around the collar 301 with respect to each other. Therefore, the outer surface of the rear section 102 exerts a biasing force on the ridge 322. As the injection device 1 and the auxiliary device 2 approach each other, the biasing force moves the arms away from each other. The lower portion 324 of each arm 320 is deflected outwardly and pivoted about the corresponding support element 326. However, the upper portion 323 of each arm is prevented from pivoting by the corresponding tab. This causes a reaction force to be exerted by the lower portion 324 of each arm 320 due to the elasticity of each arm 320, resisting the injection device 1 from attempting to enter the injection device receiving channel 307. However, when the auxiliary device 2 is further rotated onto the injection device 1, the ridges 322 are aligned with the left and right recesses 107 and due to the elasticity of the arms 320 engage the recesses 107.

Referring to FIG. 10, when the auxiliary device 2 is further rotated to engage the ridge 322 within the recess 107, the rear section 102 of the injection device 1 is received within the injection device receiving channel 307. The lower positioning surface 317 of the collar 301 contacts the underside of the outer surface of the injection device 1 and the upper positioning surface 316 contacts the opposite side of the outer surface of the injection device 1. Auxiliary device 2 for injection device 1 after ridge 322 engages in recess 107
There is significant resistance to further movement of the. Because, in part, the lower locating surface 317 and the upper locating surface 316 abut the outer surface of the injection device. The upper locating surface 316 and the lower locating surface 317 are partially offset from each other, and the upper locating surface 316 is disposed between the lower locating surface and the ridge 322. The opposite movement of the auxiliary device 2 with respect to the injection device 1 is limited by the engagement of the ridge 322 in the depression 107. The injection device 1 is also located against the base 312 of the channel 307.

  The body 300 is fitted to the injection device 1 by the collar 301 extending circumferentially around the injection device 1 at the front end of the body 300 and the ridge 322 engaging in the recess 107 at the rear end of the body 300. It will be understood that

  When the user places the auxiliary device 2 on the injection pen 1 and in that place the auxiliary device 2 is rotated slightly around the longitudinal axis to the desired position, the ribs 105 are inside the body 300. Not received in the rib receiving recess 318. In this case, the rib 105, which abuts the base 312 of the channel 307, is spaced from the exact location within the rib receiving recess 318 so that the auxiliary device 2 is not completely positioned on the injection pen 1. There is. Furthermore, the ridge 322 abuts the outer surface of the rear section 102 of the injection device 1 but is not located in the corresponding depression 107. The user should be aware that the auxiliary device 2 was not correctly fitted to the injection pen 1 as it does not receive any tactile feedback from the fitting of the ridge 322 and the depression 107. The user should also notice that the rear end of the auxiliary device is separated from the injection device 1. To accurately position the auxiliary device 2 in place with respect to the injection device 1, the user need only rotate the auxiliary device 2 relative to the injection device 1 about the longitudinal axis of the injection device 1. . As the auxiliary device 2 and the injection device 1 move relative to each other, the locating ribs and the rib receiving recess 318 align with each other. At this point, the ridge 322 is aligned with the recess 107 and engages the recess 107. Therefore, tactile feedback is provided by the engagement of the ridge 322 and the depression 107, and the user can determine that the auxiliary device 2 and the injection device 1 are correctly positioned with respect to each other.

  Similarly, if the auxiliary device 2 was not correctly aligned longitudinally with the injection device 1, the rib 105 and the rib receiving recess 318 would not be aligned and the rib would not be located in the recess. Furthermore, the ridge 322 is offset from the depression 107. Due to the relative movement of the auxiliary device 2 and the injection device 1 in the direction along the longitudinal axis of the injection device 1, the ribs are located in the recesses and the ridges are located in the depressions 107. At this point, the auxiliary device 2 and the injection device 1 are fully engaged with each other.

  After the ridge 322 is engaged in the depression 107, the injection device 1 is fully positioned within the injection device receiving channel 307, as shown in FIGS. 11 and 12. Here, the outermost surface of the display window 13 is aligned with the lowermost surface of the upper part of the auxiliary device 2. The auxiliary device 2 fits within the injection device receiving channel 307 when the auxiliary device and the injection pen 1 are in this relative position, and the outer surface of the housing 10 of the injection device 1 and the most of the auxiliary device 2 are close together. The shape is such that a plurality of contact points or contact areas are formed between the lower surface and the surface. The rib 105 is engaged in the rib receiving recess 318 when the auxiliary device 2 is positioned with respect to the injection pen 1 such that the ridges 322 are each located in the depression 107. Therefore, the precise alignment of the auxiliary device 2 with respect to the injection device 1 is provided in two ways: firstly by the positioning of the rib 105 in the rib receiving recess 318 and secondly by the ridge 322 in the recess 107. Provided by the positioning of.

  It will be appreciated that the arrangement described above prevents movement of the injection device 1 relative to the auxiliary device 2. Radial movement of the auxiliary device 2 from the injection device 1 is prevented by the collar 301 extending around the injection device 1. Radial movement of the auxiliary device 2 from the injection device 1 is also prevented by the engagement of the ridge 322 in the depression 107. Engagement of the ridge 322 within the recess 107 also prevents movement of the auxiliary device 2 about the longitudinal axis of the injection device 1 along the longitudinal axis of the injection device 1. Furthermore, movement of the auxiliary device 2 around the longitudinal axis of the injection device 1 along the longitudinal axis of the injection device 1 is further prevented by the rib 105 being received in the rib receiving recess 318.

  To remove the auxiliary device 2 from the injection device 1, the user exerts a pushing force on a button 330 arranged on the outside of the body 300. The pushing force can be exerted by the fingers and thumb. When the two buttons are depressed by the pushing force exerted by the user, the actuating element 332 on the rear surface of each button 330 acts against the concave surface of the upper portion 323 of each arm 320. Therefore, the upper portion 323 of each arm 320 is biased and deformed by the corresponding actuating element 332.

  The support element 324 acts as a fulcrum and the arm 320 is pivoted about the support element. The distal end of the upper portion 323 is immobilized by the upper portion 323 located against the tab 328. However, the free end 321 of the lower part 324 is free to move outwards, so that the lower part 324 pivots around the support element 324. Therefore, each arm 320-like ridge 322 is moved away. This causes the ridge 322 to disengage from the depression 107.

  After the ridge 322 has been moved out of the recess 107, the user can then rotate the rear end of the auxiliary device 2 away from the injection device 1 about an axis extending orthogonal to the long axis of the opening 309. . When the ridge 322 is free of the depression 107, the user receives relatively little resistance when the rear end of the body 300 is moved away from the injection device. It will be appreciated that the cooperation between the rib 105 and the rib receiving recess 318 thus does not pose any obstacle to separating the auxiliary device 2 and the injection pen 1. The injection device 1 can then be slid through the opening 306 formed in the collar 301.

  In the above embodiments, the lower locating surface is defined by the lower portion of the inner surface of the collar, but it will be appreciated that the lower locating surface may be formed by another element on the lower portion of the collar. In addition, it is possible to form cuts in the collar.

  In the embodiments described above, the upper locating surface is defined by the upper portion of the inner surface of the collar, but it will be appreciated that the upper locating portion may also be defined by the base of the channel. In such an arrangement, the inner surface of the collar and the base of the channel can be stepped from each other. The upper locating portion can be formed by another element on the upper portion of the collar. Alternatively, the upper locating portion can be formed by another element on the base of the channel.

The arm, which acts as a support member, is configured to withstand movement of the elongate body 300 in a direction along the longitudinal axis very well. Thus, the elongate body 300 is immovable in a direction along the longitudinal axis of the injection device 1 when the auxiliary device is engaged with the injection device 1. However, the support member on which the ridges are arranged can have an alternative arrangement. In such an arrangement, the support member may have a flap arrangement or may have a triangular structure, the ridges being located at one corner and the fixation to the elongate body of the auxiliary device 2. The tool is located in the other two corners. These two other corners can be separated by the axial length of the auxiliary device 2.
The triangular structure can have three perimeters or can be sheet-like. The triangular structure can be planar or curved.

  In the embodiments described above, the support member was elastic, but it will be appreciated that the support member can be rigid and the ridges can be elastic. Alternatively, both the support member and the ridge can be elastic.

  An alternative form of the auxiliary device 2 will now be described with reference to FIGS. The reference numbers from the previous embodiments are retained. The arrangement and configuration of many of these components and features are generally the same as those described above, and thus detailed description is omitted.

  The auxiliary device 2 has a main body 400 and a collar 401. The body 400 is elongated and has a longitudinal axis. The upper portion 408 of the collar 401 is integrally formed with the body 400. The lower portion 409 of the collar extends from the upper portion 408 of the collar 401. An injection device receiving channel 407 is formed in the lower surface 403 of the body 400. Channel 407 is shown in dashed lines in FIG. Channel 407 extends parallel to the longitudinal axis of body 400. The channel 407 is arcuate in cross section and is arranged to receive a portion of the posterior section 102 of the injection device 1.

  The collar 401 comprises an upper portion 408 defined at the front end 404 of the body 400 and a lower portion 409, forming part of the closure 410. Both the upper part 408 and the lower part 409 form an opening 406 through which the injection device 1 can be received. The rear section 102 of the injection device 1 is received between the body 400 and the closure 410 when the injection device 1 is received through the opening 406. The closure 410 is hingedly attached to the upper portion 408 and thus the body 400 by a hinge (not shown). The closure 410 is pivotally attached to the body 400 about the axis of rotation. Thus, the lower portion 409 of the collar 401 is pivotally attached to the upper portion 408. The closure 410 is pivoted towards the injection device 1 when it is received through the opening 406 to secure the auxiliary device 2 in a unique position relative to the outer surface of the injection device 1. Is composed of. The axis of rotation of closure 410 extends perpendicular to the longitudinal axis of channel 407.

  A closed channel 411 is formed in the closure 410 (see FIG. 18). The closed channel 411 extends perpendicular to the axis of rotation of the closure 410. The closed channel 411 has an arcuate shape in cross section and is arranged to receive a portion of the posterior section 102 of the injection device 1. The upper edge 412 of the closure 410 is chamfered. The upper edge 412 acts as a guiding surface, as will become apparent below.

  Left and right arms 413 that act as support members extend from the lower surface 403 of the body 400. The left arm 413 extends from the left side of the body 400 and the right arm extends from the right side of the body 400. As shown in FIGS. 18 to 20, the arm 413 hangs substantially vertically from the lower surface 403 of the main body 400 of the auxiliary device 2. Thus, the arms 413 are formed on opposite sides of the injection device receiving channel 407 and are spaced from each other.

A ridge 414 is located at the free end 415 of each arm. The ridge 414 acts as an engagement element and engages in a recess 107 formed in the outer surface of the rear section 102 of the injection device 1. Each ridge 414 is configured to be received within a corresponding depression 107. The ridges 414 are shaped so as to closely correspond to the shape of the depression 107. In this way, the ridges 414 fit snugly within their respective depressions 107 when the auxiliary device 2 is correctly positioned on the injection device 1. The outer dimensions of the ridges 414 are slightly smaller than the inner dimensions of the depressions 107, thus ensuring that the ridges 414 fit within their respective depressions. The free ends 415 of each arm 413 have a slight inward deflection so that the free ends 415 flare towards each other.

  The arms 413 extend slightly from the body 400, with the arms slightly extended apart from each other. Therefore, the ease of inserting the injection device therebetween is increased. Alternatively, the arms 413 extend parallel to each other. The arm 413 has elasticity. Alternatively, a biasing element (not shown), such as a U-shaped spring, can be coupled to each arm 413. The effect of the elasticity of arm 413 is to urge it to a particular position. The position where the arm 413 is initially located is such that the distance between the innermost surfaces of the ridges 414 is slightly larger than the diameter of the rear section 102 of the injection device 1. Thus, the ridge 414 is initially not biased into the recess 107 when aligned.

  The closed channel 411 formed in the closure 410 has an arcuate base 416 and two sides 417 that stand upright from the base 416. The arcuate base 416 of the closed channel 411 is configured to receive the posterior section 102 of the injection device 1 such that the outer surface of the injection device 1 lies tangentially. The two side surfaces 417 extend parallel to each other, but are spaced apart from each other. The width of the closed channel 411 between the opposite sides 417 is slightly larger than the diameter of the rear section 102 of the injection device 1 so that the injection device 1 can be received therebetween. The distance between the outer surfaces of each arm 413 opposite the ridged side is slightly greater than the width of the closed channel 411 between opposing sides 417. As will become apparent below, the side surfaces 417 act as guide elements, spreading the arms 413 inward and holding them in the engaged position.

  As shown in FIG. 14, the auxiliary device 2 is initially positioned with respect to the injection pen 1 such that the opening 406 of the collar 401 is aligned with the rear end of the injection device 1. The body 400 is oriented such that the longitudinal axis of the injection device receiving channel 407 is tilted with respect to the longitudinal axis of the injection device 1. Closure 410 is initially in the open position, in which position closure 409 is rotated away from body 400. Therefore, the lower portion 409 of the collar is rotated relative to the upper portion 408.

  The collar 401 is then slid over the posterior section 102 of the injection device 1 as shown in FIG. Therefore, the rear section 102 of the injection device 1 is received through the opening 406 of the collar 401. The auxiliary device 2 is relative to the injection device 1 such that the ends of the left and right arms 413, in particular the ridges 414, are just in contact with or slightly spaced from the housing 10 of the injection device 1. Positioned.

  To position the auxiliary device 2 on the injection device 1, the body 400 of the auxiliary device 2 is retracted towards the injection device 1, so that the rear section 102 of the injection device 1 is received in the injection device receiving channel 407. The injection device receiving channel 407 is shaped such that the injection device 1 is easily received within the injection device receiving channel 407 and lies against the injection device receiving channel 407. The arms 413 are arranged and extend on both sides of the injection device 1. However, the arms 413 are initially positioned such that the distance between the innermost surfaces of the ridges 414 is slightly larger than the diameter of the rear section 102 of the injection device 1. Thus, the ridge 414 is not initially biased into the recess 107 when aligned with the recess 107.

When the injection device 1 is positioned in the channel 407, the fins 105 projecting from the rear end of the injection device 1 are in the fin receiving recess 418 (see FIGS. 18-20) formed in the channel 407. Accepted by. The user aligns the fins 105 with the recesses 418 to ensure that the fins 105 are received within the recesses 418 and that the injection device and the auxiliary device 2 are in precise alignment with respect to each other. . When the user places the auxiliary device 2 on the injection device 1 and in that place the auxiliary device 2 is rotated slightly around the longitudinal axis to the desired position, the ribs 105 are inside the body 400. Not received in the rib receiving recess 418. In this case, the rib 105 abutting the channel 407 is spaced from the precise location within the rib receiving recess 418 so that the auxiliary device 2 is not completely positioned on the injection pen 1. Moreover, the ridges 414 are not aligned with the corresponding depressions 107. The user should be aware that the back end of the auxiliary device standing upright from the injection device 1 did not align the auxiliary device 2 correctly. To accurately position the auxiliary device 2 in place with respect to the injection device 1, the user need only rotate the auxiliary device 2 relative to the injection device 1 about the longitudinal axis of the injection device 1. . As the auxiliary device 2 and the injection device 1 move relative to each other, the rib 105 and the rib receiving recess 418 are aligned with each other and the rib is received in the rib receiving recess 418. At this point, the ridge 414 is also aligned with and engages the depression 107.

  Similarly, if the auxiliary device 2 was not correctly aligned longitudinally with the injection device 1, the rib 105 and the rib receiving recess 418 would not be aligned and the rib would not be located in the recess. Due to the relative movement of the auxiliary device 2 and the injection device 1 in the direction along the longitudinal axis of the injection device 1, the ribs are located in the recesses and the ridges are located in the depressions 107.

  When the user positions the auxiliary device 2 on the injection device 1, in particular by fitting the positioning rib 105 in the positioning channel 418, the user fixes the auxiliary device 2 to the injection device 1. You can This is accomplished by the user moving closure 410 from an open position where closure 410 is rotated away from body 400 and rotating closure 410 toward body 400 into a fixed position. Movement continues until contact occurs between the top edge of the closure and the bottom edge of the body.

  To engage the ridge 414 in the recess 107 and thus the auxiliary device 2 with the injection device 1, the user exerts a force on the closure 410 from the open position shown in FIGS. And move the closure to the fixed position shown in FIG.

  As closure 410 is rotated relative to body 400 to move from the open position to the fixed position, upper edge 412 of each sidewall 417 of closed channel 411 contacts free end 415 of arm 413. With continued movement of closure 410 towards body 400, upper edge 412 of sidewall and sidewall 417 itself act on arm 413 to bias free end 415 of arm 413 into injection device receiving chamber 407. Spread inward towards the injected injection device 1. When the injection device 1 is aligned in the injection device receiving chamber 407 in the exact position described above, the ridge 414 is aligned with the depression 107. Thus, when the arms are biased inwardly towards each other, the ridges 414 engage within the recesses 107 formed in the outer surface of the injection device 1.

  As best seen in FIG. 20, when the closure 410 is in the locked position and engaged with the body 400, the injection device 1 is received in the closed channel 411 formed in the closure 410 and by the arm 413. It is tightened, as is the body 400 and closure 410. The outer surface of the injection device 1 lies against the base 416 of the closed channel 411. The arm 413 is immovable outwardly by the arm 413 being in contact with the side wall 417 of the closed channel 411. Also, the closure 410 ensures that the injection device 1 is tightly housed within the injection device receiving channel 407 and is held in place by the closure 410.

  Movement of the auxiliary device 2 along the longitudinal axis of the injection pen 1 is constrained by the fit between the ridge 414 and the depression 107. Furthermore, rotation of the auxiliary device 2 around the longitudinal axis of the injection device 1 is also suppressed by the fit between the ridge 414 and the depression 107. Movement and rotation of the auxiliary device 2 with respect to the injection device 1 is further prevented by the locating ribs 105 contacting the body 400 of the auxiliary device 2.

  After the closure 410 has been moved into its fixed position, the injection device 1 is fully positioned within the injection device receiving channel 407. Here, the outermost surface of the display window 13 is aligned with the OCR. Therefore, the exact alignment of the auxiliary device 2 with respect to the injection device 1 is provided in two ways: firstly by the positioning of the rib 105 in the rib receiving recess 418 and secondly by the ridge 414 in the recess 107. Provided by the positioning of.

  The closure 410 is held in a fixed position by a latch arrangement 419 formed on the closure 410 that engages a capture arrangement formed on the body 400. One of the latching or catching arrangement is biased towards the other arrangement so that when the latch and catcher overlap, the catch engages the catcher and locks closure 410 into the locked position. Hold in. The catching and / or latching arrangement is elastic so that when force is exerted on the closure 410 to pull the closure 410 away from the body 400, the engagement between the two arrangements is overcome and the closure 410 then relative to the body 400. Can be freely rotated. In this embodiment, the capture arrangement (not shown) is formed by two arms that act as support members extending from the body 400. In this arrangement, the catcher is formed by the outer surface of each arm 413, but the catcher can be an opening or recess formed in each arm 413, or separate from the arms. can do. The latching arrangement 419 is a protrusion formed on the side wall 417 of the closed channel 411. When the closure 410 is guided into a fixed position and the arm 413 is received in the closed channel 411 and lies against the side wall 417 of the closed channel 411, the arm 413 is urged towards the side wall 417 due to its elasticity. It Therefore, the protrusion on the side wall is located in contact with the outer surface of each arm 413 and is pressed against the outer surface. Alternatively, the protrusions are aligned with openings or recesses formed in each arm, the arms are biased outward, and the protrusions are engaged in the openings or recesses. The closure 410 is then maintained in a fixed position relative to the body 400 by the arm engaging a protrusion on the closure 410.

  When force is applied to the closure 410 to pull the closure 410 away from the body 400, it overcomes the engagement between the protrusions engaged in the opening or recess and the closure 410 is then free to rotate with respect to the body 400. be able to. The holding unit that holds the closure 410 in the fixed position can be formed on only one side of the closure 410.

  When the closure 410 is pulled away from the body 400, the arms 413 slide along the sidewalls 417 of the closed channels 411 until the free end 415 of each arm 413 is pulled away from the closed channels 411. Each arm is splayed outward to the initial position due to the elasticity of the arm. Therefore, each arm 413 moves away from the injection device 1. The ridges 414 are disengaged from the recesses 107 in the injection device 1 when the arms 413 move away from each other.

  After the ridge 414 has been biased from the depression 107, the user can then slide the injection device 1 through the opening 406 formed in the collar 401 to separate the auxiliary device 2 from the injection device 1. .

  In the embodiments described above, the ribs 105 and rib receiving recesses aid in the orientation and alignment of the auxiliary device 2 on the injection device 1, but in an alternative arrangement the ribs 105 and rib receiving recesses 318 are omitted. It will be appreciated that the precise alignment between the auxiliary device 2 and the injection device 1 is provided by the engagement of the ridges and depressions 107.

  Other alternative arrangements ensuring the exact relative position between the auxiliary device 2 and the injection device 1 are conceivable to the person skilled in the art, all such alternatives being claimed. Within the scope of the present invention, unless explicitly excluded by a language in the range of.

  When using embodiments of the invention, the user has the following advantages, among others:

  The user can use the most convenient disposable insulin syringe.

  The auxiliary device is attachable and removable (reusable).

  The alignment unit ensures that the light sensor is aligned with the dose display. Therefore, the user does not have to manually adjust the orientation of the auxiliary device.

  The engagement unit ensures that the auxiliary device is fixedly attached to the injection device 1. Therefore, the auxiliary device cannot be inadvertently removed from the injection device.

  The release arrangement allows the engagement unit to be easily disengaged from the injection device. This allows the auxiliary device to be separated from the injection device without undue effort by the user. Furthermore, during engagement and disengagement of the auxiliary device to the injection device, damage to the auxiliary device and the injection device is prevented.

The term "drug" or "drug" as used herein 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 is a peptide, protein, polysaccharide, vaccine, DNA, RNA, enzyme, antibody or fragment thereof, hormone Or an oligonucleotide, or a mixture of the above pharmaceutically active compounds,
Here, in a further embodiment, the pharmaceutically active compound is diabetic, or a diabetic-related complication such as diabetic retinopathy, thromboembolism such as deep vein thromboembolism or pulmonary thromboembolism, acute coronary syndrome. (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis, and / or prophylaxis,
Here, in a further embodiment, the pharmaceutically active compound comprises at least one peptide for the treatment and / or prevention of diabetes or complications associated with diabetes, such as diabetic retinopathy,
Here, in a further embodiment, the pharmaceutically active compound is at least one human insulin or human insulin analogue or derivative, glucagon-like peptide (GLP-1) or an analogue or derivative thereof, or exendin-3 or exendin. -4 or exendin-3 or analogs or derivatives of exendin-4.

Insulin analogues are, 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 at position B29, Lys may be replaced with Pro; 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-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N- (N-glumityl)- -Des (B30) human insulin; B29-N- (N-lithocolyl-γ-glutamyl) -des (B30) human insulin; B29-N- (ω- Carboxymethyl hepta decanoyl) -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-Glu-Glu-Ala-Val-Arg-Leu. -Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2 The peptide exendin-4 (1-39). ) Means.

Exendin-4 derivatives are, for example, compounds of the following list:
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 bonded to the C-terminal 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-mentioned exendin-4 derivatives.

  Hormones include, for example, gonadotropins (follitropin, lutropine, corion gonadotropin, menotropin), somatropine (somatropin), desmopressin, telluripressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, goserelin, etc., Rote List, 50, 2008. Are pituitary hormones or hypothalamic hormones or regulatory active peptides and antagonists thereof.

  As the polysaccharide, for example, glucosaminoglycan, hyaluronic acid, heparin, low molecular weight heparin, or very low molecular weight heparin, or a derivative thereof, or a sulfated form of the above-mentioned polysaccharide, for example, a polysulfated form, and / Or there are pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium.

  Antibodies are globular plasma proteins (about 150 kDa) also known as immunoglobulins that share a basic structure. These are glycoproteins because they have sugar chains attached to amino acid residues. The basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only one Ig unit), and the secretory antibody also includes a dimer having two Ig units such as IgA, a teleost. It can also be a tetramer with 4 Ig units, such as IgM, or a pentamer with 5 Ig units, such as mammalian IgM.

Ig monomer is a "Y" shaped molecule composed of four polypeptide chains, two identical heavy chains and two identical light chains linked by a disulfide bond 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 intrachain disulfide bonds that stabilize their folded structure. Each chain is composed of structural domains called Ig domains. These domains contain approximately 70-110 amino acids and are classified into different categories (eg, variable or V, and constant or C) based on their size and function. They have a characteristic immunoglobulin fold that creates a "sandwich" shape in which the two β-sheets are held together by the interaction between a 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 antibody's isotype, 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 containing about 450 amino acids, δ containing about 500 amino acids, and μ and ε having about 550 amino acids. Each heavy chain has two regions, the constant region (C _H ) and the variable region (V _H ). In one species, the constant regions are essentially the same for all antibodies of the same isotype, but different for antibodies of different isotypes. Heavy chains γ, α, and δ have a constant region composed of three tandem Ig domains and a hinge region for adding flexibility, and heavy chains μ and ε have four immunoglobulins. -Has a constant region composed of domains. The variable region of the heavy chain differs 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, designated 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 has two light chains that are always identical, and for each mammalian antibody there is only one type of light chain, kappa or lambda.

  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 for each light chain (VL) and three for the heavy chain (HV) are involved in binding the antigen, ie its antigen specificity. These loops are called complementarity determining regions (CDRs). Since the CDRs from both the VH and VL domains contribute to the antigen binding site, it is the heavy and light chain combination 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 whole antibody from which it was derived. Limited protein digestion with papain cleaves the Ig prototype into three fragments. Two identical amino terminal fragments, each containing one complete light chain and about half the heavy chain, are antigen binding fragments (Fabs). A third fragment of similar size but containing the carboxyl terminus at half the position of both heavy chains with interchain disulfide bonds is the crystallizable fragment (Fc). Fc contains carbohydrates, complementary binding sites, and FcR binding sites. Limited pepsin digestion yields a single F (ab ') 2 fragment that contains both the Fab fragment and the hinge region containing the H-H interchain disulfide bond. F (ab ') 2 is bivalent for antigen binding. The disulfide bond of F (ab ') 2 can be cleaved to obtain Fab'. Furthermore, the variable regions of the heavy and light chains can be fused to form a single chain variable fragment (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, a cation selected from alkali or alkaline earth, for example, Na +, K +, or Ca2 +, or an ammonium ion N + (R1) (R2) (R3) (R4) (wherein R1 ~ R4
Independently of one another: hydrogen, an optionally substituted C1 to C6 alkyl group, an optionally substituted C2 to C6 alkenyl group, an optionally substituted C6 to C10 aryl group, or an optionally substituted C6 to C10 hetero. (Meaning an aryl group). Further examples of pharmaceutically acceptable salts can be found in "Remington's Pharmaceutical Sciences," 17th Edition, Alfonso R .; Gennaro (eds.), Mark Publishing Company, Easton, Pa. , U. S. A. , 1985 and Encyclopedia of Pharmaceutical Technology.

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

  When one of the buttons 330 is pushed inward by the user, the actuating element 332 of each button 330 is biased inward. The actuating element 332 presses the convex surface of the upper part 323 of the corresponding arm 320. The upper portion 323 then deforms under the force applied by the actuating element 332. The support element 326 acts as a fulcrum and the arm 320 is pivoted about the support element. The distal end of the upper portion 323 is immobilized by the upper portion 323 located against the tab 328. However, the free end 321 of the lower part 324 is free to move outwards, so that the lower part 324 pivots around the support element 326.

  When both buttons are pressed, the lower portions 324 of the two arms 320 are rotated around their respective support elements 326. Therefore, the free ends 321 of the arm lower portions 324 are moved away from each other. When the push on each button is released, the biasing force acting on the upper portion 323 of each arm is also released, thus the lower portion of each arm is returned to the neutral position due to the elasticity of arm 320.

The support element 326 acts as a fulcrum and the arm 320 is pivoted about the support element. The distal end of the upper portion 323 is immobilized by the upper portion 323 located against the tab 328. However, the free end 321 of the lower part 324 is free to move outwards, so that the lower part 324 pivots around the support element 326.
Therefore, each arm 320-like ridge 322 is moved away. This causes the ridge 322 to disengage from the depression 107.

Claims (16)

An auxiliary device for a manually operable injection device,
With the main body;
A mating unit configured to releasably attach the body to the injection device at a particular position relative to an outer surface of the injection device.   The auxiliary device of claim 1, wherein the mating unit comprises a collar extending from the body configured to receive the injection device, such that the injection device extends through the collar.   The auxiliary device according to claim 1 or claim 2, wherein the mating unit further comprises an engagement unit configured to engage the auxiliary device with the injection device.   The engagement unit further comprises a support member having an engagement element, the engagement element engaging within a recess on the injection device when the body is positioned in a unique position relative to the outer surface of the injection device. The auxiliary device of claim 3, configured to:   The support member is a first support member and the engagement unit further comprises a second support member, wherein an engagement element is arranged at a free end of each support member, the free end of the support member being The auxiliary devices of claim 4, wherein the auxiliary devices are biased towards each other.   Each support member is pivotally mounted within the body about an intermediate section, and thus can urge the free ends of the support members away from each other to disengage the ridge from the recess. An auxiliary device according to claim 5.   The auxiliary device of claim 4, wherein the collar comprises a closure movable toward the body to secure the body to the injection device.   The closure is rotatable towards the body to a fixed position, which acts on the support member to recess the engagement element when the closure is in the fixed position and thus the body is fixed to the injection device. The auxiliary device of claim 7, wherein the auxiliary device is configured for entry.   9. The auxiliary device of claim 8, wherein the mating unit further comprises a capture arrangement configured to releasably retain the closure in a fixed position.   10. An auxiliary device according to any one of claims 7-9, wherein the body has an injection device receiving channel and the axis of rotation of the closure relative to the body extends perpendicular to the longitudinal axis of the injection device receiving channel.   The mating unit further comprises a first locating surface and a second locating surface spaced from each other to receive the injection device therebetween, the collar slidably receiving the injection device therethrough. A third position, which is configured to be pivoted between a first position that is capable of and a fixed position where the first and second locating surfaces lie against the outer surface of the injection device. The auxiliary device according to any one of 6 above.   The auxiliary device according to claim 11, wherein the engagement unit is configured to engage the injection device when the collar is pivoted into a fixed position. The auxiliary device according to claim 12, wherein the second locating surface is arranged between the first locating surface and the engagement unit.   The auxiliary device according to any one of claims 1 to 13, wherein the fitting unit further comprises a positioning recess in the body, the positioning recess being configured to fit a positioning rib on the injection device. .   15. The optical reading arrangement further comprising: an optical reading arrangement directed to the display of the injection device when the body is attached to the injection device at a position specific to the outer surface of the injection device. The auxiliary device according to claim 1.   A kit comprising the injection device according to any one of claims 1 to 15 and an auxiliary device.

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