Injection Device with Mounting Aid for a Supplementary Device

Abstract

A mounting aid for attaching a supplementary device to an injection device, wherein the injection device has an elongated housing extending in an axial direction, the mounting aid comprising a body extending in the axial direction, configured to receive at least a portion of the housing and having at least one radially extending engaging member to engage with a correspondingly shaped engaging member of the housing when in a specific position relative to the housing, and wherein the body comprises a side wall with an abutment face facing in a proximal direction, wherein the abutment face is defined on a plane that is inclined to the axial direction.

Claims

1. An injection device comprising: a housing extending in a longitudinal direction and comprising at least one housing engaging member to releasably mount a mounting aid in a specific position on an outside surface of the housing, and with at least one engaging structure to releasably mount a supplementary device in a device specific position on the outside surface of the housing, the mounting aid being attached to the housing, the mounting aid being configured to support attaching of the supplementary device to the injection device, the mounting aid comprising: a body configured to receive at least a portion of the housing and having at least one radially extending body engaging member to engage with the at least one housing engaging member of the housing when in the specific position on the outside surface of the housing, wherein the body of the mounting aid comprises a side wall with an abutment face facing in a proximal longitudinal direction, wherein the abutment face is defined on a plane that is inclined to the longitudinal direction.

2. The injection device according to claim 1, wherein the housing comprises a distal section and a proximal section and wherein the at least one housing engaging member is located on an outside of a side wall of the distal section and comprises a longitudinal recess to positively engage with the at least one radially extending body engaging member of the mounting aid.

3. The injection device according to claim 1, further comprising a visual label at a specific circumferential section on the outside surface of the housing.

4. The injection device according to claim 1, wherein the abutment face is planar and wherein an imaginary surface normal of the abutment face extends non-parallel to the longitudinal direction.

5. The injection device according to claim 1, wherein the body of the mounting aid comprises a tubular shaped receptacle to enclose at least a distal section of the housing.

6. The injection device according to claim 1, wherein the body of the mounting aid is cup shaped and comprises a closed end section towards a longitudinal distal end.

7. The injection device according to claim 1, wherein the at least one body engaging member protrudes inwardly from the side wall of the body.

8. The injection device according to claim 1, wherein the at least one body engaging member comprises a longitudinal stop to longitudinally abut with a correspondingly shaped longitudinal counter stop of the housing engaging member.

9. The injection device according to claim 8, wherein the body engaging member comprises at least two oppositely directed longitudinal stops to simultaneously engage with correspondingly shaped longitudinal counter stops of the housing engaging member.

10. The injection device according to claim 1, wherein the at least one body engaging member comprises at least one tangential stop to abut in a tangential direction with a correspondingly shaped tangential counter stop of the housing engaging member.

11. The injection device according to claim 10, wherein the at least one tangential stop is formed by at least one tangential side edge of the at least one body engaging member.

12. The injection device according to claim 5, wherein an inner cross section of a proximal end of the receptacle is larger than or equal to a cross section of a proximal section of the housing.

13. The injection device according to claim 1, wherein the body comprises a visual label on an outside surface or wherein the body comprises a distally extending recess at a proximal end of the side wall.

14. The injection device according to claim 13, wherein by at least one of the visual label and the distally extending recess the mounting aid is unambiguously aligned with at least one indicator provided on the outside surface of the housing when the mounting aid is in the specific position on the an outside surface of the housing.

15. A kit comprising: an injection device, the injection device comprising: a housing extending in a longitudinal direction and comprising at least one housing engaging member to releasably mount a mounting aid in a specific position on an outside surface of the housing, and further comprising at least one engaging structure to releasably mount a supplementary device in a device specific position on the outside surface of the housing, a mounting aid attachable to the housing, the mounting aid being configured to support attaching of the supplementary device to the injection device, the mounting aid comprising: a body configured to receive at least a portion of the housing and having at least one radially extending body engaging member to engage with the at least one housing engaging member of the housing when in the specific position on the outside surface of the housing, the body comprising a side wall with an abutment face facing in a proximal longitudinal direction, wherein the abutment face is defined on a plane that is inclined to the longitudinal direction, a supplementary device comprising a device body and at least one device engaging member to releasably mount the device body in the device specific position on the outside surface of the injection device, wherein the device body comprises a device abutment face to align and to abut with the abutment face of the mounting aid when the mounting aid is attached to the injection device in the specific position.

16. The kit according to claim 15, wherein the device abutment face is defined on a plane that is inclined to the longitudinal direction.

17. The kit according to claim 15, wherein the device abutment face is in abutment with the abutment face of the mounting aid when the device engaging member is engaged with the at least one engaging structure of the housing.

18. The kit according to claim 15, wherein the device abutment face is in abutment with the abutment face of the mounting aid when the supplementary device is in the device specific position on the outside surface of the housing.

19. A method of attaching a supplementary device to an injection device, the injection device comprising a housing extending in a longitudinal direction, the housing comprising at least one housing engaging member for releasably mounting a mounting aid in a specific position on an outside surface of the housing and comprising at least one engaging structure to releasably mount the supplementary device in a device specific position on the outside surface of the housing, the method comprising the steps of: providing the mounting aid, the mounting aid comprising a body configured to receive at least a portion of the housing and having at least one radially extending body engaging member, the body further comprising a sidewall with an abutment face facing in a proximal longitudinal direction, wherein the abutment face is defined on a plane that is inclined to the longitudinal direction, mounting the mounting aid in the specific position on the outside surface of the housing, and providing of the supplementary device comprising a device body and at least one device engaging member, wherein the device body comprises a device abutment face, mounting the supplementary device in the device specific position on the outside surface of the housing and bringing the device abutment face in alignment and in abutment with the abutment face of the mounting aid.

20. The method according to claim 19, further comprising the step of engaging the device engaging member with the engaging structure of the housing by bringing the device abutment face in alignment and in abutment with the abutment face of the mounting aid.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0115] In the following, embodiments of the injection device and the supplemental device are described in detail by making reference to the drawings, in which:

[0116] FIG. 1 schematically shows a manually operable injection device,

[0117] FIG. 2 shows a schematic illustration of a supplementary device to be releasably attached to the injection device of FIG. 1,

[0118] FIG. 3 shows a perspective view of the supplementary device of FIG. 2 releasably attached to the injection device of FIG. 1,

[0119] FIG. 4 shows a schematic view of the supplementary device in a state where it is mounted to the injection device,

[0120] FIG. 5 shows a perspective side view of the supplementary device oriented to be mounted to the injection device,

[0121] FIG. 6 shows a side view of the supplementary device with the injection device received through a collar of the supplementary device,

[0122] FIG. 7 shows a side view of the supplementary device releasably attached to the injection device,

[0123] FIG. 8 shows a cross-sectional rear view of the supplementary device releasably attached to the injection device with resilient arms of a fixing unit in an engaged position with the injection device,

[0124] FIG. 9 shows a cross-sectional rear view of the supplementary device releasably attached to the injection device with resilient arms of a fixing unit in a disengaged position with the injection device,

[0125] FIG. 10 schematically shows the mounting aid and the injection device prior to a mutual assembly,

[0126] FIG. 11 shows the mounting aid attached to the injection device in a specific position,

[0127] FIG. 12 shows a kit comprised of the injection device, the mounting aid and the supplementary device attached to the injection device,

[0128] FIG. 13 shows the kit during or prior to the assembly of the supplementary device to the injection device to which the mounting aid is preassembled,

[0129] FIG. 14 is a cross-section through the mounting aid,

[0130] FIG. 15 is a cross-section through a distal section of the injection device,

[0131] FIG. 16 is a longitudinal cross-section through the distal section of the injection device with the mounting aid attached thereto according to a first embodiment,

[0132] FIG. 17 shows an alternative embodiment of a configuration according to FIG. 16,

[0133] FIG. 18 shows a third embodiment of the mutual fixing of the mounting aid and the injection device in accordance to the illustration of FIG. 16,

[0134] FIG. 19 is a top view onto the injection device with the mounting aid attached thereto, wherein a portion of the mounting aid covers a portion of a label on the outer circumference of the injection device and wherein the covered portion of said label is provided on the outer circumference of the mounting aid,

[0135] FIG. 20 is an alternative embodiment of the mounting aid with a different kind of label on its outside surface,

[0136] FIG. 21 is another alternative embodiment of the outside label of the mounting aid and

[0137] FIG. 22 shows another embodiment of the mounting aid with a recessed portion at a proximal end to visualize a label on the outside surface of the injection device located underneath.

DETAILED DESCRIPTION

[0138] FIG. 1 is an exploded view of an injection device 1, which may for instance represent Sanofi's Solostar (R) insulin injection pen.

[0139] The injection device 1 of FIG. 1 is a pre-filled, disposable injection pen that comprises a housing 10 and contains an insulin container 14, to which a needle 15 can be affixed. The needle is protected by an inner needle cap 16 and an outer needle cap 17, which in turn can be covered by a cap 18. An insulin dose to be ejected from injection device 1 can be selected by turning a dosage knob 12, and the selected dose is then displayed via a dosage window or display 13, for instance in multiples of so-called International Units (IU), wherein one IU is the biological equivalent of about 45.5 micrograms of pure crystalline insulin (1/22 mg). An example of a selected dose displayed in dosage window or display 13 may for instance be 30 lUs, as shown in FIG. 1. It should be noted that the selected dose may equally well be displayed differently, for instance by an electronic display. It will be understood that dosage window relates to the section of the injection device through or on which the selected dosage is visible.

[0140] Turning the dosage knob 12 causes a mechanical click sound to provide acoustical feedback to a user. The numbers displayed in dosage window or display 13 are printed on a sleeve 19 that is contained in housing 10 and mechanically interacts with a piston in the insulin container 14. When needle 15 is stuck into a skin portion of a patient, and then injection button 11 is pushed, the insulin dose displayed in display 13 will be ejected from injection device 1. When the needle 15 of injection device 1 remains for a certain time in the skin portion after the injection button 11 is pushed, a high percentage of the dose is actually injected into the patient's body. Ejection of the insulin dose also causes a mechanical click sound, which is however different from the sounds produced when using dosage knob 12.

[0141] Injection device 1 may be used for several injection processes until either insulin container 14 is empty or the expiration date of injection device 1 (e.g. 28 days after the first use) is reached. Furthermore, before using injection device 1 for the first time, it may be necessary to perform a so-called “prime shot” to remove air from insulin container 14 and needle 15, for instance by selecting two units of insulin and pressing injection button 11 while holding injection device 1 with the needle 15 upwards. For simplicity of presentation, in the following, it will be exemplarily assumed that the ejected doses substantially correspond to the injected doses, so that, for instance when making a proposal for a dose to be injected next, this dose equals the dose that has to ejected by the injection device. Nevertheless, differences (e.g. losses) between the ejected doses and the injected doses may of course be taken into account.

[0142] The housing 10 of the injection device 1 comprises a front section 101 and a rear section 102. The needle 15 is affixed to the front end of the front section 101 and the dosage knob 12 extends from the rear end of the rear section 102. The front section 101 has a smaller diameter than the rear section 102 of the injection device housing 10.

[0143] 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 over the front section 101. The cap 18 covers the front section 101 and a lip 18a of the cap 18 locates against the shoulder 103.

[0144] A cap retaining ridge 104 is formed on the outer surface of the front section 101 of the housing 10 of the injection device 1. The cap retaining ridge 104 is disposed proximate to, but spaced from, the shoulder 103. The ridge 104 extends diametrically about the front section 101. The ridge 104 locates over one or more retaining elements (not shown) formed on the inner surface of the cap 18 to retain the cap 18 in position over the front section 101. Alternatively, the cap retaining ridge 104 locates in a corresponding diametrically extending recess (not shown) formed on the inner surface of the cap 18.

[0145] The injection device 1 further comprises additional elements. A rib 105 protrudes from an outer surface 106 of the injection device 1. The rib 105 acts as an alignment element for locating the body in a specific position relative to the outer surface 106 of the injection device 1. The rib 105 upstands from the outer surface 106 of the injection device 1 between the dosage display 13 and the dosage knob 12. The dosage knob 12 is disposed on the rear section 102 of the injection device housing 10. The rib 105 is elongate and extends parallel to the longitudinal axis of the injection device 1.

[0146] Left and right engaging structure 107 actually formed as indents 107 (refer to FIG. 6) are formed in the outer surface 106 of the injection device 1. The two indents 107 are formed in the rear section 102. Each indent 107 is formed proximate to the rear end of the injection device housing 10. The indents 107 are formed generally diametrically opposite to each other on left and right sides of the injection device 1. The indents 107 have chamfered sides.

[0147] FIG. 2 is a schematic illustration of an embodiment of a supplementary device 2 to be releasably attached to injection device 1 of FIG. 1. Supplementary device 2 comprises a housing 20 with a mating unit configured to embrace the housing 10 of injection device 1 of FIG. 1, so that supplementary device 2 sits tightly on housing 10 of injection device 1, but is nevertheless removable from injection device 1, for instance when the injection device 1 is empty and has to be replaced. FIG. 2 is highly schematic, and details of one embodiment of the physical arrangement are described below with reference to FIG. 3. The wings or clip features 20-1 and 20-2 as shown in FIG. 2 generally represent engaging members 140 by way of which the supplementary device 2 is releasably attachable to the outer surface of the injection device 2. The engaging members 140 as shown in FIG. 8 may be generally realized in many different ways, e.g. by mutually engaging positive interlock means, such like resilient clip members.

[0148] Supplementary device 2 contains optical and acoustical sensors for gathering information from injection device 1. At least a part of this information, for instance a selected dose (and optionally a unit of this dose), is displayed via display unit 21 of supplementary device 2. The dosage display 13 of injection device 1 is obstructed by supplementary device 2 when attached to injection device 1.

[0149] Supplementary device 2 further comprises three user input transducers, illustrated schematically as a button 22. These input transducers 22 allow a user to turn on/off supplementary device 2, to trigger actions (for instance to cause establishment of a connection to or a pairing with another device, and/or to trigger transmission of information from supplementary device 2 to another device), or to confirm something.

[0150] FIG. 3 shows a view of the supplementary device 2 with the arrangement of the mating unit and housing shown in greater detail. The supplementary device 2 is shown mounted to the injection device 1 in FIG. 3. The housing 20 of the supplementary device 2 has a body 300 and a collar 301. The body 300 is elongate and the display unit 21 is disposed on an upper side 302 of the body 300. The collar 301 extends from a lower side 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. The collar 301 extends from the body 300 at an acute angle to the longitudinal axis of the elongate body 300.

[0151] The collar 301 has an aperture 306 formed therethrough. The collar 301 is configured to receive the injection device 1 through the aperture 306. A channel 307 (refer to FIG. 6) is formed in the lower side 303 of the body 300. The channel 307 is elongate and extends between the front end 304 and the rear end 305 of the body 300.

[0152] Two wings 308, acting as protective walls, extend downwardly from the lower side 303 of the body 300. The wings 308 are spaced from each other and distend from either side of the channel 307. Therefore, the injection device 1 is receivable between the wings 308. The wings 308 are disposed at the rear end 305 of the body 300, at an opposite end of the body 300 to the collar 301.

[0153] The collar 301 and channel 307 form part of an alignment arrangement or alignment unit. The alignment unit is configured to locate the body in a specific position relative to the outside surface 106 of the injection device 1. The alignment unit forms part of the mating unit configured to embrace the housing 10 of injection device 1 to maintain the supplementary device in a specific position on the injection device 1.

[0154] The supplementary device 2 further comprises an engaging unit or arrangement configured to releasably mount the body to the injection device 1. The collar 301 also forms part of the engaging unit. The engagement unit forms part of the mating unit.

[0155] The features that contribute to correct alignment of the supplementary device 2 on the injection device 1 can be termed an alignment arrangement or alignment unit. The features that contribute to engagement of the supplementary device 2 to the injection device 1 can be termed an engaging unit or engaging arrangement.

[0156] FIG. 4 shows a schematic view of the supplementary device 2 of FIG. 2a in a state where it is attached to injection device 1 of FIG. 1. With the housing 20 of supplementary device 2, a plurality of components are comprised. These are controlled by a processor 24, which may for instance be a microprocessor, a Digital Signal Processor (DSP), Application Specific Integrated Circuit (ASIC), Field Programmable Gate Array (FPGA) or the like. Processor 24 executes program code (e.g. software or firmware) stored in a program memory 240, and uses a main memory 241, for instance to store intermediate results. Main memory 241 may also be used to store a logbook on performed ejections/injections. Program memory 240 may for instance be a Read-Only Memory (ROM), and main memory may for instance be a Random Access Memory (RAM).

[0157] A supplementary memory 243 may also be used to store a logbook on performed ejections/injections. Program memory 240 may for instance be a Read-Only Memory (ROM), main memory 241 may for instance be a Random Access Memory (RAM), and supplementary memory 243 may for instance be a flash memory. The supplementary memory 243 may comprise part of the supplemental device 2 or may alternatively be removably couplable thereto by a USB-type interface for instance or other connection.

[0158] In an example embodiment, processor 24 interacts with a first button 22, via which supplementary device 2 may for instance be turned on and off. A second button 33 is a communications button. The second button may be used to trigger establishment of a connection to another device, or to trigger a transmission of information to another device. A third button 34 is a confirm or OK button. The third button 34 can be used to acknowledge information presented to a user of supplementary device 2. The buttons 22, 33, 34 may be any suitable form of user input transducers, for instance mechanical switches, capacitive sensors or other touch sensors.

[0159] Processor 24 controls a display unit 21, which is presently embodied as a Liquid Crystal Display (LCD). Display unit 21 is used to display information to a user of supplementary device 2, for instance on present settings of injection device 1, or on a next injection to be given. Display unit 21 may also be embodied as a touch-screen display, for instance to receive user input.

[0160] Processor 24 also controls an optical sensor 25, embodied as an Optical Character Recognition (OCR) reader, that is capable of capturing images of the dosage display 13, in which a currently selected dose is displayed (by way of numbers printed on the sleeve 19 contained in injection device 1, which numbers are visible through the dosage display 13). OCR reader 25 is further capable of recognizing characters (e.g. numbers) from the captured image and to provide this information to processor 24. Alternatively, unit 25 in supplementary device 2 may only be an optical sensor, e.g. a camera, for capturing images and providing information on the captured images to processor 24. Then processor 24 is responsible for performing OCR on the captured images.

[0161] Processor 24 also controls light-sources such as light emitting diodes (LEDs) 29 to illuminate the dosage display 13, in which a currently selected dose is displayed. A diffuser may be used in front of the light-sources, for instance a diffuser made from a piece of acrylic glass. Furthermore, the optical sensor may comprise a lens (e.g. an aspheric lens) leading to a magnification (e.g. a magnification of more than 3:1)

[0162] Processor 24 further controls a photometer 26, that is configured to determine an optical property of the housing 10 of injection device 1, for example a color or a shading. The optical property may only be present in a specific portion of housing 10, for example a color or color coding of sleeve 19 or of an insulin container comprised within injection device 1, which color or color coding may for instance be visible through an opening or window in housing 10 (and/or in sleeve 19). Information on this color is then provided to processor 24, which may then determine the type of injection device 1 or the type of insulin contained in injection device 1 (e.g. SoloStar Lantus with purple color and SoloStar Apidra with blue color). Alternatively, a camera unit may be used instead of photometer 26, and an image of the housing, sleeve or insulin container may then be provided to processor 24 to determine the color of the housing, sleeve or insulin container by way of image processing. Further, one or more light sources may be provided to improve reading of photometer 26. The light source may provide light of a certain wavelength or spectrum to improve color detection by photometer 26. The light source may be arranged in such a way that unwanted reflections, for example by dosage display 13, are avoided or reduced. In an example embodiment, instead of or in addition to photometer 26, a camera unit may be deployed to detect a code (for instance a bar code, which may for instance be a one- or two-dimensional bar code) related to the injection device and/or the medicament contained therein. This code may for instance be located on the housing 10 or on a medicament container contained in injection device 1, to name but a few examples. This code may for instance indicate a type of the injection device and/or the medicament, and/or further properties (for instance an expiration date).

[0163] Processor 24 further controls (and/or receives signals from) an acoustic sensor 27, which is configured to sense sounds produced by injection device 1. Such sounds may for instance occur when a dose is dialled by turning dosage knob 12 and/or when a dose is ejected/injected by pressing injection button 11, and/or when a prime shot is performed. These actions are mechanically similar but nevertheless sound differently (this may also be the case for electronic sounds that indicate these actions). Either the acoustic sensor 27 and/or processor 24 may be configured to differentiate these different sounds, for instance to be able to safely recognize that an injection has taken place (rather than a prime shot only).

[0164] Processor 24 further controls an acoustical signal generator 23, which is configured to produce acoustical signals that may for instance be related to the operating status of injection device 1, for instance as feedback to the user. For example, an acoustical signal may be launched by acoustical signal generator 23 as a reminder for the next dose to be injected or as a warning signal, for instance in case of misuse. Acoustical signal generator may for instance be embodied as a buzzer or loudspeaker. In addition to or as an alternative to acoustical signal generator 23, also a haptic signal generator (not shown) may be used to provide haptic feedback, for instance by way of vibration.

[0165] Processor 24 controls a wireless unit 28, which is configured to transmit and/or receive information to/from another device in a wireless fashion. Such transmission may for instance be based on radio transmission or optical transmission. In some embodiments, the wireless unit 28 is a Bluetooth transceiver. Alternatively, wireless unit 28 may be substituted or complemented by a wired unit configured to transmit and/or receive information to/from another device in a wire-bound fashion, for instance via a cable or fibre connection. When data is transmitted, the units of the data (values) transferred may be explicitly or implicitly defined. For instance, in case of an insulin dose, always International Units (IU) may be used, or otherwise, the used unit may be transferred explicitly, for instance in coded form.

[0166] Processor 24 receives an input from a pen detection switch 30, which is operable to detect whether the pen 1 is present, i.e. to detect whether the supplementary device 2 is coupled to the injection device 1. A battery 32 powers the processor 24 and other components by way of a power supply 31.

[0167] The supplementary device 2 of FIG. 4 is thus capable of determining information related to a condition and/or use of injection device 1. This information is displayed on the display 21 for use by the user of the device. The information may be either processed by supplementary device 2 itself, or may at least partially be provided to another device (e.g. a blood glucose monitoring system).

[0168] The mating unit and mutually interacting engaging members of the injection device 1 and the supplementary device 2, such like for releasably mounting the supplementary device to the injection device in a specific position relative to an outside surface of the injection device will now be described in detail.

[0169] The correct alignment of the supplementary device 2 on the injection device 1 ensures that the OCR reader 25 is correctly aligned with the dosage window 13. Correct alignment allows correct operation and reliable readings. Ensuring that there can be correct alignment between the supplementary device 2 and the injection device 1 in use allows a simpler design for the OCR reader 25, in particular because it does not need to be designed to be able to accommodate different alignments between the devices 1, 2.

[0170] Referring to FIG. 5, the supplementary device 2 is shown prior to mounting the supplementary device 2 on the injection device 1. In FIG. 5, the supplementary device 2 is shown orientated relative to the rear section 102 of the housing 10 of the injection device 1 so that the rear section 102 is receivable through the aperture 306 formed in the collar 301.

[0171] The housing 20 of the supplementary device 2 comprises the body 300 and the collar 301. The elongate body 300 has a longitudinal axis, with the collar 301 distending downwardly from the front end 304 of the body 300. The channel 307 (refer to FIGS. 7 and 8) formed in the lower side 303 of the body 300 extends from the aperture 306 formed in the collar 301. Therefore, an upper portion of the aperture 306 forms part of the elongate channel extending between the front end and the rear end of the housing 20.

[0172] The aperture 306 has a front opening 309. The front opening 309 is formed in a front face 310 of the housing 20. The front face 310 may be planar. The edge of the front opening 309 is defined on a plane extending at an angle to the longitudinal axis of the elongate body 300. The front opening 309 has an elliptical shape. The width of the front opening 309 at its minor axis or conjugate diameter corresponds to or is slightly greater than the diameter of the rear section 102 of the injection device 1. The width of the front opening 309 at its major axis or transverse diameter is greater than the diameter of the rear section 102 of the injection device 1. It will be understood that the rear section 102 of the injection device 1 is receivable through the opening 309 so that it extends through the aperture 306.

[0173] The channel 307 is shown in FIGS. 7 to 9. 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. Therefore, the rear section 102 of the injection device is receivable therein and the outer surface of the injection device 1 locates against the channel base 312. The optical sensor 25 is embedded in the channel base 312 to face into the channel 312.

[0174] The collar 301 defines an upper part 314 and a lower part 315. The upper part 314 is integrally formed with the body 300 and thus extends from the base 312 of the channel 307. The lower part 315 opposes, but is at least partially offset from, the upper part 314. In the present embodiment, the upper part 314 is defined by the upper half of the inner surface of the collar 301 and the lower part 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, with the base 312 of the channel 307 extending from the cylindrical surface. Therefore, the arcuate base of the channel 307 and the inner cylindrical surface of the collar are formed to arc about the same longitudinal axis.

[0175] A lower locating surface 317 is defined on the lower part 315 of the collar 301. An upper locating surface 316 is defined on the upper part 314 of the collar 301. The upper and lower locating surfaces oppose each other. When the injection device is received through the aperture, the upper and lower locating surfaces 316, 317 are configured to locate against the outer surface of the injection device 1. the locating surfaces 316, 317 are brought into contact with the injection device 1 by rotating the supplementary device 2 about an axis extending perpendicular to the major axis of the opening 309 so that the upper and lower locating surfaces are moved towards the outer surface of the injection device 1. The central axis of the cylindrical aperture extending through the collar is brought into co-axial alignment with the longitudinal axis of the injection device 1.

[0176] In the present embodiment, the base 312 of the channel extends co-planar with the upper part of the collar 301. Therefore, the base 312 of the channel also locates against the outer surface of the injection device 1 when the supplementary device 2 is rotated about an axis extending perpendicular to the major axis of the opening 309 so that the upper and lower locating surfaces are moved to lie against the outer surface of the injection device 1. Therefore, it will be understood that the upper locating surface may be formed by the upper part 314 of the collar, or by the base 312 of the channel 307. Alternatively, the lower locating surface is formed on one or more locating elements protruding into the aperture from the lower part of the collar. Similarly, the upper locating surface is formed on one or more locating elements protruding into the aperture or the injection device receiving channel.

[0177] A rib receiving recess 318 (refer to FIGS. 8 and 9) is formed in the base 312 of the channel 307. The rib receiving recess 318 is dimensioned to receive the rib 105 protruding from the outer surface 106 of the injection device 1. The rib receiving recess 318 is dimensioned so as to correspond closely to the shape and size of the locating rib 105 that is present on the injection pen 1. The rib receiving recess 318 is slightly larger than the locating rib 105 so as to ensure that the locating rib 105 can be easily located within the recess. Therefore, the rib 105 acts as an alignment element for locating the body in a specific position P relative to the outer surface 106 of the injection device 1 when the rib 105 is received in the rib receiving recess 318. The rib receiving recess 318 therefore aids the correct alignment and orientation of the body 300 on the injection device 1.

[0178] The rib receiving recess 318 is formed at the end of the supplementary device 2 that is closest to the dosage knob 12 when the supplementary device 2 is fitted to the injection device 1. Left and right arms 320, acting as support members, extend below the injection device receiving channel 307 on left and right sides of the body 300. As shown in FIGS. 8 and 9, a lower part 324 of each arm 320 depends substantially vertically from the lower side of the body 300 of the supplementary device 2. Therefore, the arms 320 extend either side of the injection device receiving channel 307 and are spaced from each other.

[0179] The left arm 320 has a left protuberance 322 disposed at a free end 321 of the lower part 324. The right arm 320 also has a right protuberance 322 disposed at a free end 321 of the lower part 324. Each protuberance 322 acts as an engaging element to engage in the indents 107 formed in the outer surface of the rear section 102 of the injection device 1. The protuberance 322 on the left arm 320 is configured to be received in the left indent 107. The protuberance 322 on the right arm 320 is configured to be received in the left indent 107. The protuberances 322 are shaped to correspond to the shapes of the indents 107 respectively. In this way, the protuberances 322 fit within the corresponding indents 107 respectively when the supplementary device 2 is correctly positioned on the injection device 1. The external dimensions of the protuberances 322 are slightly smaller than the internal dimensions of the indents 107 so as to ensure that the protuberances 322 fit within their respective indent.

[0180] In the present embodiments, the right protuberance 322 is shaped to correspond closely to the shape of the right indent 107. In this way, the right protuberance 322 fits snugly within the right indent 107 when the supplementary device 2 is correctly positioned on the injection pen 1. The left protuberance 322 is shaped similarly to the right protuberance 322, although it is less tall. Put another way, it is like the right protuberance 322 but with the top part is missing or cut off. This is the reason for the end face of the left protuberance 322 having a larger area than the right protuberance 322. The different sizes for the protuberances 322 helps the protuberances find engagement within the indents 107. The right protuberance 322 can be considered to be a master to the left protuberance 322, which is a slave.

[0181] Each arm 320 has an upper part 323 and a lower part 324. A step 325 is formed at a mid section of each arm 320, with the upper part 323 depending from one side of the step 325 and the lower part 324 depending from the other side. The protuberance 322 is formed at the free end of the lower part 324. The lower part 324 extends from the step 325 at an angle to the upper part 323.

[0182] A support element 326 is disposed in the left side of the body 300. Another support element 326 is disposed in the right side of the body 300. Each support element 326 is disposed in the body 300 and spaced from an outer shell 327 of the body 300 to define a gap. The left arm 320 is received in a left side of the body 300. The right arm 320 is received in a right side of the body 300. The arms 320 are disposed behind the wings 308 that depend from the body 300. The wings 308 may be formed from a transparent material. This allows a user to be able to view the locations of the arms 320 relative to the indents 107, which may help the user to locate the supplementary device 2 correctly on the injection device 1.

[0183] As can be seen from FIG. 8, the wings, or protective walls 308, extend slightly further in a downwards direction than the arms. The left arm 320 extends through the gap formed in the left side of the body 300 and the right arm 320 extends through the gap on the right side of the body 300. The step 325 formed at the mid-section of each arm 320 locates against the corresponding support element 326. The step 325 locates each arm 320 so that the lower part 324 extends below the support element 326. The end of the upper part 323 of each arm 320 locates against a tab 328 extending from an inner surface of the body outer shell 327. The upper part 323 of each arm 320 is therefore retained in position in the body 300 and extends between the support element 326 and the tab 328.

[0184] The distance between each support element 326 and tab 328 is slightly less than the length of the upper part 323 of each arm 320. Therefore, when the upper part 323 of each arm 320 is disposed between the corresponding element 326 and the tab 328, the upper part 323 of each arm 320 is deformed to have an arcuate shape. Each arm 320 is resilient. The upper part 323 bows into a convex shape towards the outer shell of the body 300. Therefore, the step 325 is biased against the support element 326 and the free end of the upper part 323 is biased against the tab 328. The upper part 323 of each arm 320 between the free end and the step is urged towards the outer shell 327.

[0185] The lower part 324 of each arm 320 extends from the upper part 323 and through the gap defined between the support element 326 and the outer shell 327. The lower parts 324 of the arms 320 are splayed towards each other, extending from the support element 326. The effect of the resilience of the upper part 323 of each arm 320 is to bias the lower part 324 of each arm 320 into a certain position. The position into which the lower part 324 of each arm 320 is initially located is such that the distance between the innermost surfaces of the protuberances 322 is slightly less than the distance between the bottoms of the indents 107. The effect of the bias of each arm 320 is to resist movement of the protuberances 322 and the lower parts 324 of the arms 320 away from one another.

[0186] The arms 320, acting as support members, are restrained from moving in a direction along the longitudinal axis of the elongate body 300. This assists in maintaining the supplementary device 2 in the correct location after engagement of the supplementary device on the injection pen 1 even in the presence of forces acting to move the supplementary device 2 along the longitudinal axis of the injection pen 1. The arms 320 can be termed support members because they support the protuberances.

[0187] Left and right buttons 330 are mounted on the left and right sides of the body 300. An aperture 331 is formed through the outer shell 327 on each side of the body 300. A protrusion, acting as an actuating element 332, is formed on the rear side of each button 330 and extends through the corresponding aperture 331 to act on the upper part 323 of the corresponding arm 320 and apply a biasing force thereon.

[0188] When one of the buttons 330 is pressed inwardly by a user the actuating element 332 of each button 330 is biased inwardly. The actuating element 332 urges against the convex surface of the upper part 323 of the corresponding arm 320. The upper part 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 urged to pivot about the support element. The distal end of the upper part 323 is prevented from moving by the tab 328 against which the upper part 323 is located. However, the free end 321 of the lower part 324 is free to move outwardly and so the lower part 324 pivots about the support element 324.

[0189] When both buttons 330 are pressed, the lower parts 324 of the two arms 320 are urged to rotate about their respective support elements 324. Therefore, the free ends 321 of the arm lower parts 324 are urged away from each other. The release of the pressing force on each button releases the biasing force acting on the upper part 323 of each arm and so the lower part of each arm is urged to return to its neutral position due to the resilience of the arms 320.

[0190] As is shown in FIG. 5, the supplementary device 2 is initially located with respect to the injection pen 1 such that the opening 309 to the aperture 306 in the collar 301 is aligned with the rear end of the injection device 1. The body 300 is orientated so that the longitudinal axis B of the injection device receiving channel 307 is inclined with respect to the longitudinal axis D of the injection device 1.

[0191] The collar 301 is then slid over the rear section 102 of the injection device 1, as shown in FIG. 6. The width of the front opening 309 at its minor axis or conjugate diameter corresponds to or is slightly greater than the diameter of the rear section 102 of the injection device 1. The width of the front opening 309 at its major axis or transverse diameter is greater 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 aperture 306 of the collar 301.

[0192] In order to locate the supplementary device 2 on the injection device 1, the supplementary device 2 is rotated relative to the injection device 1 about the transverse axis T extending perpendicular to the major axis of the opening 309, hence the longitudinal axis B of the supplementary device 2. The longitudinal axes D of the injection device 1 and the injection device receiving channel 307 are rotated towards each other. Furthermore, the upper and lower locating surfaces 316, 317 are moved towards the outer surface of the injection device 1.

[0193] As the supplementary device 2 and injection device 1 are rotated relative to each other the free ends 321 of the right and left arms 320, in particular the protuberances 322, brought into contact with the outer surface of the injection device housing 10. The protuberances 322 here contact the housing to the left and right sides of the display window 13.

[0194] In order to engage the supplementary device 2 with the injection device 1, the user first arranges the supplementary device 2 with respect to the injection device 1 as shown in FIG. 6, and then applies a further force downwards on the supplementary device 2 while at the same time applying a force upwards on the injection device 1. Therefore, the supplementary device 2 and injection device are urged to rotate relative to each other about the collar 301. A biasing force is therefore applied to the protuberances 322 by the outer surface of the rear section 102. As the injection device 1 and the supplementary device 2 are urged to move closer together, the biasing force results in the arms being urged away from each other.

[0195] The lower part 324 of each arm 322 is urged to deflect outwardly, and to pivot about the corresponding support element 326. However, the upper part 323 of each arm is prevented from pivoting by the corresponding tab. This causes a reaction force to be applied by the lower part 324 of each arm due to the resilience of each arm 320, which resists entry of the injection device 1 into the injection device receiving channel 307. However, as the supplementary device 2 is further rotated over the injection device 1, the protuberances 322 become aligned with the left and right indent 107 and, due to the resilience of the arms 320, engage with the indents 107.

[0196] Referring to FIG. 7, as the supplementary device 2 is further rotated with regard to the transverse axis T to engage the protuberances 322 in the indents 107, the rear section of the injection device 1 is received in the injection device receiving channel 207. The lower locating surface 317 of the collar 301 is urged into contact with a lower side of the outer surface of the injection device 1 and the upper locating surface 316 is urged into contact with an opposing side of the outer surface of the injection device 1. Once the protuberances 322 engage in the indents 107, there is significant resistance to further movement of the supplementary device 2 relative to the injection device 1, due in part to the lower and upper locating surfaces 316, 317 abutting the outer surface of the injection device. The upper and lower locating surfaces 316, 317 are partially offset from each other, with the upper locating surface 317 being disposed between the lower locating surface and the protuberances 322. Movement of the supplementary device 2 relative to the injection device 1 in the opposite direction is restricted by the protuberances 322 being engaged in the indents 107. The injection device 1 also locates against the base 312 of the channel 307.

[0197] It will be understood that the body 300 is mated to the injection device 1 by the collar 301 extending circumferentially around the injection device 1 at a front end of the body 300, and the protuberances 322 engaging in the indents 107 at the rear end of the body 300.

[0198] In FIGS. 10-15 one embodiment of a mounting aid 400 for attaching the supplementary device 2 to the injection device 1 is illustrated. The mounting aid 400 is configured as a protective cap 18. It is provided with special technical features by way of which it effectively serves to support and to facilitate attachment of the supplementary device 2 to the injection device 1. The mounting aid 400 comprises a body 401, which when attached to the injection device 1 also extends in axial direction, hence along the long axis D of the injection device 1. Throughout the Figures an axial distal direction is denoted with reference number 3 whereas an opposite and proximal axial direction is denoted with reference number 4. The body 401 of the mounting aid comprises a somewhat tubular-shaped sidewall 402 that forms a cup-shaped receptacle 403 to receive a distal or section 101 or front section of the housing 10 of the injection device 1. The mounting aid 400 is also equipped with a clip 405 in order to fasten the entire injection device 1 e.g. to a pocket.

[0199] The distal end 412 of the body 401 is typically closed so as to confine the interior volume of the receptacle 403 in distal direction 3. Near its proximal end 413 the mounting aid 400 comprises an opening to receive the distal section 101 of the injection device 1. Near or at the proximal end 413 the body 401 further comprises an abutment face 410 that faces substantially in proximal direction 4. The abutment face 410 is defined on a plane that is inclined to the axial direction and hence to the axial elongation of the tubular-shaped body 401. The inclination is expressed by the imaginary surface normal N as shown in FIG. 11. There it is apparent that the surface normal and hence the plane of the abutment face 410 is inclined or slanted with regard to the long axis D of the injection device 1 and of the body 401.

[0200] This inclination of the somewhat planar abutment face 410 represents a symmetry-breaking feature that corresponds to a complementary-shaped symmetry-breaking feature of the supplementary device 2. As shown in FIGS. 5 and 12 the distally facing front face 310 of the supplementary device 2 is also somewhat inclined with regard to the longitudinal axis B of the supplementary device 2. The inclination of the supplementary device's abutment face 310 and the inclination of the abutment face 410 of the mounting aid 400 mutually correspond so as to completely align when the supplementary device is correctly mounted and attached to the injection device. The inclined abutment face 410 serves as a tactile and visually detectable mounting support for correctly assembling the supplementary device 2 onto the outside surface 106 of the injection device 1.

[0201] The proximal end 413 of the mounting aid 400 may be located proximally from the shoulder 103 of the housing 10 of the injection device 1. It is hence conceivable that the housing of the device 10 is shoulder-free and the proximal end face 310 of the mounting aid 400 forms a rim like shoulder providing a proximally facing but distally located abutment face for the correct and specific assembly and attachment of the supplementary device 2 to the injection device 1. Consequently the axial elongation of the mounting aid 400 may exceed the axial elongation of the housing's front section 101 or of the cartridge holder 450 forming such the front section 101.

[0202] A kit 500 comprised of the injection device 1, the supplementary device 2 and the mounting aid 400 assembled to the injection device is illustrated in FIG. 12. The mounting aid 400 is assembled and fixed to the injection device 1 in a specific position M relative to the injection device 1 thereby defining a specific position P for assembling the supplementary device 2 to the injection device 1. The mutually corresponding abutment faces 310 and 410 mutually abut or engage along the entire circumference of the side wall 452 and the collar 301.

[0203] As it is shown in more detail in FIGS. 14, 16-18 the mounting aid 400 comprises two radially inwardly extending engaging members 406, 416 by way of which the mounting aid 400 is fixable and attachable to the housing 10 of the injection device 1. In the illustrated embodiment the engaging members 406, 416 extend radially inwardly from the sidewall 402 of the body 401. By means of the engaging member 406 the mounting aid 400 is axially as well as tangentially fixable to the distal section 101 of the injection device 1. As it is shown in more detail in FIG. 15 the distal section 101, typically configured as a cartridge holder 450, comprises a tubular-shaped body 451 with a sidewall 452. At least in the axial section that is shown in FIG. 15 the sidewall 452 comprises two geometrically oppositely located engaging members 456 that are configured as longitudinal slits 466. Each one of the engaging members 456 comprises two tangential side edges 457, 458 as well as a distal edge 472 forming a distal axial stop 471 and a proximal edge 462 forming a proximal axial stop 461.

[0204] The lateral side edges 457, 458 form a tangential stop 459 for the engaging members 406, 416 of the mounting aid 400. When engaged and fastened to the injection device 1 a side edge 408 of the engaging member 406 gets in tangential or circumferential abutment with the side edge 458 thereby forming a tangential stop 409. Correspondingly, also the oppositely located side edge 407 engages in tangential direction (w) with an oppositely located side edge 457 of the body 451. In this way a tangential or circumferential stop 459 is provided on the body 451 by way of which the mounting aid 400 is rotationally lockable or locked to the housing 10 of the injection device 1.

[0205] With regard to the longitudinal axis the sketch of FIG. 16 shows that the radially inwardly extending engaging members 406 of the mounting aid 400 comprise a radially inwardly extending proximal edge 414 that is configured to axially abut with the distally facing edge 462 of the engaging member 456 of the cartridge holder 450 thereby forming an axial stop 411. The mutual abutment between the engaging members 406 with the recessed engaging member 456 therefore blocks a proximally directed displacement of the mounting aid 400 relative to the injection device 1. The axial positions of the engaging members 406, 456 therefore define the axial component of the specific position of the supplementary device 2 with regard to the injection device 1. A distally directed displacement of the mounting aid 400 with regard to the injection device 1 could be also implemented by a frictional engagement between the bodies 451, 401, which is not necessarily illustrated here.

[0206] In another embodiment partially illustrated in FIG. 17 the mounting aid 400 could be fastened to the injection device 1 with regard to the proximal direction 4 by means of a frictional engagement, which is not further illustrated. However, in distal direction 3, hence for blocking a distally directed displacement of the mounting aid 400 with regard to the injection device 1 there are provided engaging members 416 on the inside of the sidewall 402 of the mounting aid 400. Likewise the engaging members 406 as described above in connection with FIG. 16 the engaging members 416 according to FIG. 17 comprise a rather steep and radially extending distal edge 424 that acts as an axial stop 421. Lateral side edges of the engaging members 416 also form a tangential stop 419 to engage with the side edges 457, 458 in the side wall 452 of the body 451.

[0207] As illustrated in FIG. 17 the distal edges 424 of the engaging members 416 get in axial abutment with the proximally facing edge 472 of the slit 466 in the sidewall 452 of the cartridge holder 450. Due to the mutual abutment of the distal edges 424 with the proximal edges 472 the mounting aid 400 cannot be displaced any further in distal direction 3 relative to the injection device 1.

[0208] In the further embodiment as shown in FIG. 18 the mounting aid 400 comprises two different types of radially extending engaging members 406, 416. Here and as described above in connection with FIGS. 16 and 17 the engaging members 406 provide a proximally facing stop 411 preventing any further displacement of the mounting aid in proximal direction relative to the injection device whereas the engaging members 416 provide a distally facing stop 421 preventing a further distally directed displacement of the mounting aid 400 relative to the injection device 1. Alternatively it is conceivable, that the bidirectional axial as well as tangential mutual fixing between the mounting aid 400 and the injection device 1 is provided by only one pair of engaging members 406, 456 on the inside of the body 401 and on the outside of the cartridge holder 450. It is generally sufficient when the body 401 comprises only one radially inwardly extending protrusion 406 that matches in shape and geometry with a correspondingly-shaped recess on the outside surface 106 of the injection device 1.

[0209] The embodiment according to FIG. 16, wherein the radially inwardly extending engaging member 406 comprises a beveled portion 415, a disconnection of the mounting aid 400 from the injection device is rather simple and straight forward. For disassembling the mounting aid 400 from the injection device 1 the mounting aid 400 will have to be pushed or drawn in distal direction 3 relative to the injection device 1. The beveled portion 415 engaging with the proximal edge 472 of the slit 466 may lead to a temporary radial widening of the body 401 until the mounting aid 400 has been completely disassembled from the injection device 1. For inserting the injection device 1 into the receptacle 403 of the mounting aid 400 a corresponding radial widening of the body 401 may be induced by means of a radially widening shoulder portion near a distal end of the distal housing section 101 or near a distal end of the cartridge holder 450 (not illustrated).

[0210] In the embodiments as shown in FIGS. 14-18 the mutually corresponding engaging members 406, 416, 456 of the mounting aid 400 and of the injection device 1 enable two geometrically opposite mounting configurations for the mounting aid 400 to the injection device 1. The two different configurations differ by a rotation of the mounting aid 400 with regard to the longitudinal axis by 180°. However, for the supplementary device 2 to operate correctly it is required that the supplementary device 2 actually covers the display 13 of the proximal section 102 of the injection device 1. So in order to mount the mounting aid 400 correctly to the injection device 1 there is provided at least one label 430, 433, 444 on the outer surface of the body 401 of the mounting aid 400.

[0211] The outside surface 106 is provided with a label 425 or indicator.

[0212] As shown in FIG. 19 the mounting aid 400 is actually covering a distal section of the label 425. In order to indicate or to visualize an unambiguous and correct attachment of the mounting aid 400 to the injection device the proximal end 413 of the mounting aid is provided with a label 430 that is equivalent or identical to that portion of the label 425 actually being covered by the mounting aid 400. So the partially covered label 425 on the outside surface 106 of the injection device 1 is completed by the label 430 on the outside surface of the mounting aid 400.

[0213] In FIG. 20 a different configuration of a label 435 on the outside surface of a mounting aid 400 is shown. This label 435 as well as the further label 440 as shown in FIG. 21, indicate that sidewall section of the injection device 1 that is equipped and provided with the display 13. In a further embodiment as shown in FIG. 22 the proximal end 413 of the body 401 of the mounting aid 400 is provided with a cutout or recess 445 extending from the proximal end 413 and hence from the proximally facing abutment face 410 in distal direction 3.

[0214] The size and shape of the recess 445 matches with that portion of the label 425 that would be otherwise covered by the mounting aid 400 in the embodiments as shown in FIG. 19-21. In the embodiment of FIG. 22 the recess 445 provides a complete and unobstructed view of the label 425 provided on the outside surface 106 of the injection device 1. Instead of the recess 445 it is also conceivable that the body 401 of the mounting aid 400 is just provided with a transparent portion filing the recess 445 so as to allow a complete visualization of the label 425 located underneath and which is at least partially covered by the sidewall 402 of the mounting aid 400.