Injection Device with a Preselector
20200353175 ยท 2020-11-12
Inventors
Cpc classification
A61M5/20
HUMAN NECESSITIES
A61M2205/585
HUMAN NECESSITIES
A61M5/31536
HUMAN NECESSITIES
A61M2005/3125
HUMAN NECESSITIES
International classification
Abstract
An injection device for setting and injecting a dose of a medicament is provided. The injection device includes: an elongated housing extending along a longitudinal axis (z) and comprising a sidewall, a dose tracker having a portion arranged inside the housing, the dose tracker comprising at least one tracking stop feature, wherein a positional state of the dose tracker relative to the housing is indicative of a size of the dose, and a preselector comprising a preselector stop feature. Wherein the tracking stop feature and the preselector stop feature are configured to mutually engage and to block a displacement of the dose tracker beyond a predefined maximum dose positional or rotational state. The preselector is at least one of translationally or rotationally displaceable relative to the housing along a displacement path between at least two preselection positional states.
Claims
1-15. (canceled)
16. An injection device for setting and injecting a dose of a medicament, the injection device comprising: an elongated housing extending along a longitudinal axis and comprising a sidewall; a dose tracker having a portion arranged inside the housing, the dose tracker comprising at least one tracking stop feature, wherein the dose tracker is at least one of translationally or rotationally displaceable relative to the housing during setting of a dose, wherein a positional state of the dose tracker relative to the housing is indicative of a size of the dose; and a preselector comprising a preselector stop feature, wherein the tracking stop feature and the preselector stop feature are configured to mutually engage and to block a displacement of the dose tracker beyond a predefined maximum dose positional or rotational state, wherein the preselector is at least one of translationally or rotationally displaceable relative to the housing along a displacement path between at least two preselection positional states, and wherein the preselector is lockable to the housing in any of the at least two preselection positional states.
17. The injection device according to claim 16, wherein the preselector is slidably displaceable along the displacement path extending along the sidewall of the elongated housing.
18. The injection device according to claim 16, wherein the preselector is rotationally locked to the elongated housing.
19. The injection device according to claim 16, wherein the preselector comprises a sleeve portion enclosing a longitudinal portion of the dose tracker.
20. The injection device according to claim 16, wherein the preselector comprises a slider slidably arranged in a recess in an outside facing portion of the sidewall.
21. The injection device according to claim 20, wherein the slider comprises a detent structure configured to engage with a correspondingly shaped counter detent structure of the sidewall.
22. The injection device according to claim 20, wherein one of the detent structure and the counter detent structure comprises a protrusion and wherein the other one of the detent structure and the counter detent structure comprises at least two recesses separated along the displacement path, and wherein any one of the at least two recesses is configured to receive the protrusion to lock the preselector against movement along the displacement path.
23. The injection device according to claim 22, wherein the protrusion is radial.
24. The injection device according to claim 16, wherein the preselector comprises a radially outwardly facing gripping structure comprising at least two radially outwardly protruding ribs separated from each other along the displacement path.
25. The injection device according to claim 24, wherein the gripping structure is radially recessed to an outside surface of the sidewall, wherein the gripping structure is substantially flush with the outside surface of the sidewall or protrudes radially outwardly from the outside surface of the sidewall.
26. The injection device according to claim 16, wherein the preselector comprises at least one preselection indicator on an outside facing surface portion of the preselector, and wherein the elongated housing comprises a preselection window to reveal the preselection indicator.
27. The injection device according to claim 16, wherein the preselector comprises at least one preselection indicator on an outside surface portion of the preselector, and wherein the elongated housing comprises a position sensor configured to determine a position of the preselection indicator along the displacement path.
28. The injection device according to claim 16, wherein the elongated housing comprises at least two preselection indicators arranged along the displacement path, and wherein the preselector comprises a pointer coinciding with a position of at least one of the at least two preselection indicators.
29. The injection device according claim 16, wherein an outside surface of the dose tracker comprises a first surface section and a second surface section, wherein at least one of a haptic appearance, a visual appearance, a magnetic property or an electric property of the second surface section differs from a respective haptic appearance, a visual appearance, a magnetic property or an electric property of the first surface section.
30. The injection device according to claim 29, wherein the preselector comprises an aperture radially extending through the preselector to reveal a portion of the outside surface of the dose tracker.
31. The injection device according to claim 30, further comprising a slider, wherein the slider comprises a magnifying lens arranged in the aperture.
32. The injection device according to claim 16, further comprising a piston rod and a cartridge, wherein the cartridge comprises a barrel filled with the medicament and sealed in an axial proximal direction by a bung that is axially displaceable relative to the barrel by the piston rod.
33. The injection device according to claim 16, wherein the dose tracker is formed by a number sleeve that comprises a helical groove.
34. The injection device according to claim 33, wherein the helical groove is threadedly engaged with a correspondingly shaped protrusion or with a male thread on an insert piece that is attached to the sidewall of the elongated housing.
35. The injection device according to claim 34, wherein the protrusion or the male thread is on an inside facing sidewall of the insert piece, and wherein the insert piece is stationary fixed to a proximal end of the sidewall of the elongated housing.
Description
BRIEF DESCRIPTION OF THE FIGURES
[0134] In the following, example embodiments of the drive mechanism and the injection device are described in detail by making reference to the drawings, in which:
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DETAILED DESCRIPTION
[0168] The injection device 1 as shown in
[0169] When the injection device 1 is configured to administer e.g. human insulin, the dosage set by a dose dial 12 at a proximal end of the injection device 1 may be displayed in so-called international units (IU, wherein 1 IU is the biological equivalent of about 45.5 g of pure crystalline insulin (1/22 mg). The dose dial 12 may comprise or may form a dose dial.
[0170] As shown further in
[0171] The injection device 1 may be configured so that turning the dosage knob 12 causes a mechanical click sound to provide acoustical feedback to a user. The number sleeve 80 mechanically interacts with a piston in the insulin cartridge 6. When the needle 15 is stuck into a skin portion of a patient, and when the trigger 11 or injection button is pushed, the insulin dose displayed in display window 13 will be ejected from injection device 1. When the needle 15 of the injection device 1 remains for a certain time in the skin portion after the trigger 11 is pushed, a high percentage of the dose is actually injected into the patient's body. Ejection of an insulin dose may also cause a mechanical click sound, which is however different from the sounds produced when using the dose dial 12.
[0172] In this embodiment, during delivery of the insulin dose, the dose dial 12 is turned to its initial position in an axial movement, that is to say without rotation, while the number sleeve 80 is rotated to return to its initial position, e.g. to display a dose of zero units.
[0173] The injection device 1 may be used for several injection processes until either the cartridge 6 is empty or the expiration date of the medicament in the injection device 1 (e.g. 28 days after the first use) is reached.
[0174] 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 the cartridge 6 and the needle 15, for instance by selecting two units of the medicament and pressing trigger 11 while holding the injection device 1 with the needle 15 upwards. For simplicity of presentation, in the following, it will be assumed that the ejected amounts substantially correspond to the injected doses, so that, for instance the amount of medicament ejected from the injection device 1 is equal to the dose received by the user.
[0175] The expelling or drive mechanism 8 as illustrated in more detail in
[0176] The piston rod 20 is further provided with a second thread 24 at its proximal end. The distal thread 22 and the proximal thread 24 are oppositely handed.
[0177] There is further provided a drive sleeve 30 having a hollow interior to receive the piston rod 20. The drive sleeve 30 comprises an inner thread threadedly engaged with the proximal thread 24 of the piston rod 20. Moreover, the drive sleeve 30 comprises an outer threaded section 31 at its distal end. The threaded section 31 is axially confined between a distal flange portion 32 and another flange portion 33 located at a predefined axial distance from the distal flange portion 32. Between the two flange portions 32, 33 there is provided a last dose limiter 35 in form of a semi-circular nut having an internal thread mating the threaded section 31 of the drive sleeve 30.
[0178] The last dose limiter 35 further comprises a radial recess or protrusion at its outer circumference to engage with a complementary-shaped recess or protrusion at an inside of the sidewall of the housing 10. In this way the last dose limiter 35 is splined to the housing 10. A rotation of the drive sleeve 30 in a dose incrementing direction 4 or clockwise direction during consecutive dose setting procedures leads to an accumulative axial displacement of the last dose limiter 35 relative to the drive sleeve 30. There is further provided an annular spring 40 that is in axial abutment with a proximally facing surface of the flange portion 33. Moreover, there is provided a tubular-shaped clutch 60. At a first end the clutch 60 is provided with a series of circumferentially directed saw teeth. Towards a second opposite end of the clutch 60 there is located a radially inwardly directed flange.
[0179] Furthermore, there is provided a dose dial sleeve also denoted as number sleeve 80. The number sleeve 80 is provided outside of the spring 40 and the clutch 60 and is located radially inward of the housing 10. A helical groove 81 is provided about an outer surface of the number sleeve 80. The housing 10 is provided with the dosage window 13 through which a part of the outer surface of the number 80 can be seen. The housing 10 is further provided with a helical rib at an inside sidewall portion of an insert piece 62, which helical rib is to be seated in the helical groove 81 of the number sleeve 80. The tubular shaped insert piece 62 is inserted into the proximal end of the housing 10. It is rotationally and axially fixed to the housing 10. There are provided first and second stops on the housing 10 to limit a dose setting procedure during which the number sleeve 80 is rotated in a helical motion relative to the housing 10. As will be explained below in greater detail, at least one of the stops is provided by a preselector stop feature 71 provided on a preselector 70.
[0180] The dose dial 12 in form of a dose dial grip is disposed about an outer surface of the proximal end of the number sleeve 80. An outer diameter of the dose dial 12 typically corresponds to and matches with the outer diameter of the housing 10. The dose dial 12 is secured to the number 80 to prevent relative movement therebetween. The dose dial 12 is provided with a central opening.
[0181] The trigger 11, also denoted as dose button is substantially T-shaped. It is provided at a proximal end of the injection device 10. A stem 64 of the trigger 11 extends through the opening in the dose dial 12, through an inner diameter of extensions of the drive sleeve 30 and into a receiving recess at the proximal end of the piston rod 20. The stem 64 is retained for limited axial movement in the drive sleeve 30 and against rotation with respect thereto. A head of the trigger 11 is generally circular. The trigger side wall or skirt extends from a periphery of the head and is further adapted to be seated in a proximally accessible annular recess of the dose dial 12.
[0182] To dial a dose a user rotates the dose dial 12. With the spring 40 also acting as a clicker and the clutch 60 engaged, the drive sleeve 30, the spring or clicker 40, the clutch 60 and the number sleeve 80 rotate with the dose dial 12. Audible and tactile feedback of the dose being dialed is provided by the spring 40 and by the clutch 60. Torque is transmitted through saw teeth between the spring 40 and the clutch 60. The helical groove 81 on the number sleeve 80 and a helical groove in the drive sleeve 30 have the same lead. This allows the number sleeve 80 to extend from the housing 10 and the drive sleeve 30 to climb the piston rod 20 at the same rate. At a limit of travel a radial stop on the number sleeve 80 engages either with a first stop or a second stop provided on the housing 10 or provided on the preselector 70 to prevent further movement in a dose incrementing direction 4. Rotation of the piston rod 20 is prevented due to the opposing directions of the overall and driven threads on the piston rod 20.
[0183] The last dose limiter 35 keyed to the housing 10 is advanced along the threaded section 31 by the rotation of the drive sleeve 30. When a final dose dispensed position is reached, a radial stop formed on a surface of the last dose limiter 35 abuts a radial stop on the flange portion 33 of the drive sleeve 30, preventing both, the last dose limiter 35 and the drive sleeve 30 from rotating further.
[0184] Should a user inadvertently dial beyond the desired dosage, the injection device 1, configured as a pen-injector allows the dosage to be dialed down without dispense of the medicament from the cartridge 6. For this the dose dial 12 is simply counter-rotated. This causes the system to act in reverse. A flexible arm of the spring or clicker 40 then acts as a ratchet preventing the spring 40 from rotating. The torque transmitted through the clutch 60 causes the saw teeth to ride over one another to create the clicks corresponding to dialed dose reduction. Typically, the saw teeth are so disposed that a circumferential extent of each saw tooth corresponds to a unit dose.
[0185] When the desired dose has been dialed the user may simply dispense the set dose by depressing the trigger 11. This displaces the clutch 60 axially with respect to the number sleeve 80 causing dog teeth thereof to disengage. However, the clutch 60 remains keyed in rotation to the drive sleeve 30. The number sleeve 80 and the dose dial 12 are now free to rotate in accordance with the helical groove 81.
[0186] The axial movement deforms the flexible arm of the spring 40 to ensure the saw teeth cannot be overhauled during dispense. This prevents the drive sleeve 30 from rotating with respect to the housing 10 though it is still free to move axially with respect thereto. The deformation is subsequently used to urge the spring 40 and the clutch 60 back along the drive sleeve 30 to restore the connection between the clutch 60 and the number sleeve 80 when the distally directed dispensing pressure is removed from the trigger 11.
[0187] The longitudinal axial movement of the drive sleeve 30 causes the piston rod 20 to rotate through the through opening of the support of the housing 10, thereby to advance the bung 7 in the cartridge 6. Once the dialed dose has been dispensed, the number sleeve 80 is prevented from further rotation by contact of at least one stop extending from the dose dial 12 with at least one corresponding stop of the housing 10. A zero dose position may be determined by the abutment of one of axially extending edges or stops of the number sleeve 80 with at least one or several corresponding stops of the housing 10.
[0188] The expelling mechanism or drive mechanism 8 as described above is only exemplary for one of a plurality of differently configured drive mechanisms that are generally implementable in a disposable pen-injector. The drive mechanism as described above is explained in more detail e.g. in WO2004/078239A1, WO 2004/078240A1 or WO 2004/078241A1 the entirety of which being incorporated herein by reference.
[0189] The dose setting mechanism 9 as illustrated in
[0190] During dose setting and when the drive mechanism 8 or the dose setting mechanism 9 is in the dose setting mode the drive sleeve 30 rotates in unison with the dose dial 12 and with the number sleeve 80. The drive sleeve 30 is threadedly engaged with the piston rod 20, which during dose setting is stationary with regard to the housing 10. Accordingly, the drive sleeve 30 is subject to a screwing or helical motion during dose setting. The drive sleeve 30 starts to travel in proximal direction as the dose dial is rotated in a dose incrementing direction 4, e.g. in a clockwise direction. For adjusting of or correcting a size of a dose the dose dial 12 is rotatable in an opposite direction, hence in a dose decrementing direction 5, e.g. counterclockwise.
[0191] At least one of the drive sleeve 30 and the number sleeve 80 serves as a dose tracker 50 comprising a tracking stop feature 51. There is further provided a preselector 70 as a separate piece.
[0192] As illustrated with in
[0193] The preselector 70 comprises a slider 72 that is slidably displaceable inside the recess 41 of the sidewall 48 of the housing 10. The slider 72 is longitudinally displaceable between a distal stop position and a proximal stop position. The slider 72 is a component of the preselector 70. The preselector 70 further comprises a sleeve portion 71. As illustrated in
[0194] The preselector 70 is slidably displaceable along a displacement path 49 that extends along the sidewall 48 of the housing. In the presently illustrated examples the displacement path 49 extends parallel to the longitudinal axis (z) of the housing 10 of the injection device 1.
[0195] The preselector 70 is rotationally locked to the sidewall 48 of the housing. This is accomplished by at least one or several spline features 74 provided at an outside facing section of the sleeve portion 71 of the slider 70. The spline features 74 engage with correspondingly shaped grooves provided in the inside facing surface of the sidewall 48 of the housing 10. In this way, a sliding but non-rotational motion of the preselector 70 relative to the housing is provided.
[0196] As the dose dial 12 is rotated in a dose incrementing direction 4 the dose tracker 50 is rotated in the same direction and undergoes a proximally directed longitudinal displacement. The proximally directed displacement as well as the rotational displacement of the dose tracker 50 is abruptly stopped when the tracking stop feature 51 abuts with the preselector stop feature 73 of the preselector 70. The preselector 70 is fixable or lockable to the housing 10 and hence to the sidewall 48 at three different discrete longitudinal positions.
[0197] For this the preselector 70 is provided with a detent structure 76. As illustrated in
[0198] The slider 72 and the sleeve portion 71 may be integrally formed. Hence, the preselector 70 may comprise only a single component. Compared to the injection device such as described in WO 2004/078239 A1, the present injection device only requires minor modifications. Here, only a single preselector 70 must be provided and the contour and shape of the sidewall 48 of the housing 10 requires a respective modification in order to slidably receive the preselector 70.
[0199] Apart from that no further modifications are required to a commercially distributed injection device that is configured for individual, variable and user selectable setting of doses of different size.
[0200] By displacing the preselector in longitudinal direction the axial or longitudinal position of the preselector stop feature 73 is varied accordingly. By moving or displacing the preselector 70 towards the proximal direction 3 compared to the illustration of
[0201] The sleeve portion 71 of the preselector comprises a preselection indication 75. In the illustrated embodiment the preselection indication 75 comprises three consecutive numbers 1, 2, 3. Depending on the axial position of the preselector 70 relative to the housing 10 one of the preselection indications 75 will show up in the preselection window 43. As illustrated in FIG. the preselector 70 is in an intermediate position. Accordingly, number 2 is revealed in the preselection window 43. In the present example the preselection indication 75 is indicative of a maximum dose settable with the dose setting mechanism 9.
[0202] Here, the preselection indication 75 and the number as illustrated in the preselection window 43 has to be multiplied by 10 units. Accordingly, the preselection indication 75 as illustrated in FIG. indicates to a user of the device that a maximum size of 20 standard units of the medicament can be set. In
[0203] As illustrated further in
[0204] As indicated in
[0205] In
[0206] Inside the recessed portion formed by the bottom section 143 and the edge 44 the slider 172 is longitudinally displaceable between three distinct and discrete positions. For this the slider 172 comprises a detent structure 176 protruding radially from a main and substantially rectangular body of the slider 172. The detent structure 176 comprises a radial protrusion to mechanically engage with one of the correspondingly shaped recesses 147 of the counter detent structure 146 provided at the edge 144 of the recess 141. In the example as shown in
[0207] Along the displacement path 149 there are provided three preselection indications 145 that are located at regular axial or longitudinal distances from each other. Each one of the preselection indications 145 denoted as 1, 2, 3 respectively, coincide with a recess 147 of the counter detent structure 146. The protrusion 176 acts as a pointer 179 pointing to one of the preselection indications 145 that aligns with the detent structure 176.
[0208] Apart from that the example as shown in
[0209] Contrary to the example as described in connection with
[0210] The connector 172a of the slider 172 may comprise a radially inwardly extending protrusion or a recess to engage with the connector 171a. At least one of the two connectors 171a, 172a extends through a through opening 142 provided in the bottom section 143 of the sidewall 148 in the region of the recess 141. In this way, a mechanical engagement is provided between the sleeve portion 171 and the slider 172 that reaches radially through the sidewall 148 of the housing 10.
[0211] In
[0212] The injection device 1 as illustrated in
[0213] The general working principle of a further preselector 270 as shown with the example of
[0214] The recess 241 in the outside surface of the sidewall 248 comprises and forms a displacement path 249 along which the preselector 270 and hence the slider 272 thereof is longitudinally displaceable between three different discrete positions denoted as 1, 2, 3 in accordance to respective preselection indications 245 provided on the outside surface of the sidewall 248 as shown in
[0215] As shown in
[0216] Contrary to the examples as described above, the housing 10 and hence the sidewall 248 can be void of a dosage window 13. Instead, the slider 270 comprises an aperture 275 radially extending through the preselector 270 to reveal a portion of the outside surface 85 of the dose tracker 50 located underneath. In the present embodiment the aperture 275 is located in an overlapping portion of the slider 270 and the sleeve portion 271. Alternatively the aperture 275 may be exclusively provided in the slider 272.
[0217] Inside the aperture 275 there may be provided a magnifying lens 278. In this way the appearance of a dose indicating number located on the outside surface 85 of the dose tracker 50 or of the number sleeve 80 can be enlarged. This provides a better readability and discernability of numbers or dose indicating symbols on the outside surface 85 of the dose tracker 50. Alternatively or additionally the size of the aperture 275 as well as numbers or symbols provided on the outside surface 85 of the number sleeve 80 can be decreased thus enabling a further miniaturization of the injection device and of its dose setting mechanism 9.
[0218] The aperture 275 and hence the lens 278 may be provided in a longitudinal mid-section of the slider 272. The lens 278 may act and behave as a pointer 279. In the illustration of
[0219] The outside surface 85 of the number sleeve 80 and hence of the dose tracker 50 comprises a first surface section 82 and a second surface section 84 as illustrated in
[0220] The second surface portion 84 is located near the distal end of the dose tracker 50 or number sleeve 80. It is located closer to the tracking stop feature 51 than the first surface section 82. In use and when selecting of a maximum allowable dose the second surface section 84 aligns with the aperture 275 when the tracking stop feature 51 of the dose tracker 50 engages with the preselector stop feature 273 of the sleeve portion 271. It is only upon reaching the predefined maximum dose size that the visual appearance of the aperture 275 changes. This is then a clear indication to the user, that the maximum allowable dose has been set. The change from the first surface section 82 overlapping with the aperture 275 towards the second surface section 84 overlapping with the aperture 275 is an indication and confirmation to the end user that a dose pre-selected by the preselection positional state of the slider 272 and hence of the preselector 270 has been reached. The device is then ready for dose dispensing.
[0221] Here it may of particular benefit, that the housing 10 can be void of a dosage window 13. General handling and operation of the device can be thus simplified. A user has only to select one of a number of available preselection positional states of the preselector. The user then has to rotate the dose dial 12 in the dose incrementing direction 4 until the visual appearance of the aperture 275 changes or until a predefined symbol appears in the aperture 275.
[0222] The assembly of the slider 272 and the sleeve portion 271 is slidably displaced inside or on the housing 10 and is prevented against rotation due to the splined engagement of the spline feature 274 on the outside surface of the sleeve portion 271 with a correspondingly shaped spline feature on the inside surface of the sidewall 248.
[0223] The further example of an injection device 1 as shown in
[0224] In a way similar as described above in connection with the example according to
[0225] The slider 372 may be provided as a separate part to be connected to the sleeve portion 371 in the process of assembly of the injection device 1. The recess 341 also comprises a bottom section 343 that is intersected by a through opening 342 through which a mechanical connection between the slider 372 and the sleeve portion 371 extends.
[0226] The injection device 1 as illustrated in
[0227] The processor 420 may be configured to compare the positional state of the dose tracker 50. If the processor 420 determines that the positional state of the dose tracker 50 corresponds to the maximum dose positional state as governed and defined by the momentary preselection positional state of the preselector 370 the processor 420 is configured go provide a respective indicator on an electronic display 410. The second position sensor 390 is illustrated in
[0228] The preselector 370 is equipped with a preselection indicator 375 located on an outside surface of the preselector 370. As illustrated in
[0229] The preselection indication 375 may comprise an electric conductor. It may comprise a metal dome or a mental contact configured to connect or to bypass at least two electrical conductors connected to the processor 420. The preselection indication 375 is configured to interact with the position sensor 390 of the injection device 1. A position of the preselection indication 375 and hence of the slider 372 or of the preselector 370 is detectable by the second position sensor 390. For this the second position sensor 390 comprises three different sensor sections 391, 392, 393 as illustrated in
[0230] If the slider 372 and hence the preselector 370 is in a distal stop position as for instance illustrated in
[0231] The injection device 1 is provided with a display 410, configured as an electronic display. The display 410 comprises at least two display sections. In a first display section 412 a preselection indication in accordance with the actual position of the slider 372 is reproduced. As illustrated in
[0232] In the configuration according to
[0233]
[0234] The display 410 is typically provided with a processor 420 as shown in
[0235] As illustrated in
[0236] The first and the second detector elements 422, 424 are stationary with the sidewall 348. Since the first and second surface sections 382, 384 extend at the same lead as the helical groove 81 and hence the threaded engagement between the dose tracker 50 and the sidewall 348 the first detector element 422 slides along the first surface section 382. The longitudinal or axial offset between the first and the second surface sections 382, 384 is identical to a longitudinal offset or separation between the first detector element 422 and the second detector element 424. As the number sleeve 80 or the dose tracker 50 rotates relative to the sidewall 348 the first and the second surface sections 382, 384 slide along the first and the second detector elements 422, 424, respectively.
[0237] In an initial configuration, hence in a zero dose configuration as for instance shown in
[0238] Rotating the number sleeve 80 or the dose tracker 50 further until it reaches a second maximum dose configuration in which the pointer 379 of the slider 372 aligns with the preselection indication 345 provided with number 2, the situation as illustrated in
[0239] The detector elements 422, 424 may be implemented as mechanical switches configured to generate an electrical signal as long as in contact with a respective surface section 382, 384.
[0240] When getting in mechanical contact with an interrupt 383, 385 the signal generated by the detector elements 422, 424 changes. Such a signal change is detectable and processable by the first position sensor 430 and hence by the processor 420 connected with the first position sensor 430. Since the processor 420 is further connected with the second position sensor 390 the three different situations as illustrated in
[0241] The detector elements 421, 422, 424 can be implemented as mechanical switches when the surface sections 382, 384 and the interrupts 383, 385 comprise different radial height or depth on the outside surface 85 of the number sleeve 80 or of the dose tracker 50. For instance, the surface sections 382, 384 each comprise a longitudinal groove on the outside surface 85 of the number sleeve 80. The interrupts 383, 385 may flush with the outside surface of the number sleeve 80 or the dose tracker 50. When implemented as mechanical switches, the detector elements 422, 424 may each comprise a radially displaceable and spring biased pin sliding along the respective surface section 382, 384 as the number sleeve 80 is subject to a rotation relative to the housing 10. When a pin of one of the detector elements 422, 424 aligns with an interrupt 383, 385 the respective pin is depressed against the action of the spring. Such a depression is accompanied by a closing or opening of an electrical switch or contact inside the detector element 422, 424.
[0242] There is further illustrated an optional detector element 421 that serves as an on-off switch for the add-on device 400. The further detector element 421 is configured to engage with a further surface section 381 on the outside surface of the number sleeve 80. The surface sections 381 as illustrated in
[0243] As soon as the number sleeve 80 is subject to a rotation the detector element 421 and the recess 381 get out of engagement. Consequently, the detector element 421 will be subject to a radially outwardly directed depression as it starts to slide as it starts to slide outside the recess 381 and hence along the outside surface of the number sleeve 80. In this way the add-on device 400 and hence the electronic components thereof, in particular its processor 420, is switched on and the status of the further detector elements 422, 424 can be monitored and processed. By means of a detector element 421 implemented as on/off switch, electric energy consumption of the add-on device 400 can be reduced and battery lifetime can be prolonged.
[0244] When after completion of a dose dispensing procedure the detector element 421 re-engages the recess 381 the add-on device 400 is switched off and electric energy can be saved.
[0245] Alternatively, the first and/or second surface sections 382, 384 can be electrically or magnetically encoded. For instance, the surface sections 382, 384 may be electrically conductive while the interrupts 383, 385 are electrically insulating or non-conductive. It is also conceivable that the surface sections 382, 384 and the interrupts 383, 385 mutually distinguish in terms of their visual appearance or light absorption characteristic as well and/or with regards to their magnetic properties. In this way also other encoding schemes based on an optic encoding or magnetic encoding can be generally implemented. With an optically or magnetically implemented encoding of the outside surface 85 of the dose tracker 50 or the number sleeve 80 also respective first and second detector elements 422, 424 should be implemented. Here, first and second detector elements 422, 424 may be implemented as light detectors or as magnetic sensors.
[0246] In a situation wherein the slider 372 is located near the proximal end of the displacement path 349 and wherein a maximum dose has been pre-selected, i.e. with the pointer 379 of the slider 372 aligns with the preselection indication 345 provided with number 3 the configurations as shown in
[0247] The display 410, the first position sensor 430, the second position sensor 390, the detector elements 422, 424 as well as the processor 420 can be permanently assembled inside the housing 10 of the injection device 1. These electronic components may belong to the injection device 1 and hence to the dose setting mechanism 9 thereof. The injection device 1 may be further equipped with one or several electric power sources 402, such as button batteries. The electric power sources 402 can be integrated into the housing 10 or can be detachably mounted inside the housing 10 and/or its sidewall 348. In a further embodiment and as indicated in
[0248] Before discarding of a used injection device the add-on device 400 can be detached and can be attached to a new injection device 1. The add-on device 400 is further equipped with the above mentioned first and second position sensors 430, 390 in order to detect and to determine a position of the dose tracker 50 relative to the preselector 370.
TABLE-US-00001 List of reference numbers 1 injection device 2 distal direction 3 proximal direction 4 dose incrementing direction 5 dose decrementing direction 6 cartridge 7 bung 8 drive mechanism 9 dose setting mechanism 10 housing 11 trigger 12 dose dial 13 dosage window 14 cartridge holder 15 injection needle 16 inner needle cap 17 outer needle cap 18 protective cap 19 protrusion 20 piston rod 21 bearing 22 first thread 23 pressure foot 24 second thread 25 barrel 26 seal 28 threaded socket 30 drive sleeve 31 threaded section 32 flange 33 flange 35 last dose limiter 36 shoulder 40 spring 41 recess 42 through opening 43 preselection window 44 edge 46 counter detent structure 47 protrusion 48 sidewall 49 displacement path 50 dose tracker 51 tracking stop feature 60 clutch 62 insert piece 63 protrusion 64 stem 70 preselector 71 sleeve portion 72 slider 73 preselector stop feature 74 spline feature 75 preselection indication 76 detent structure 76a, b, c recess 77 gripping structure 77a, b protrusion 80 number sleeve 81 groove 82 surface section 84 surface section 85 outside surface 141 recess 142 through opening 143 bottom section 144 edge 145 preselection indication 146 counter detent structure 147 recess 148 sidewall 149 displacement path 170 preselector 171 sleeve portion 171a connector 172 slider 172a connector 173 preselector stop feature 174 spline feature 176 detent structure 177 gripping structure 179 pointer 241 recess 242 through opening 243 bottom section 244 edge 245 preselection indication 246 counter detent structure 249 displacement path 270 preselector 271 sleeve portion 272 slider 273 preselector stop feature 274 spline feature 275 aperture 276 preselection indication 277 gripping structure 278 lens 279 pointer 341 recess 342 through opening 343 bottom section 345 preselection indication 349 displacement path 370 preselector 371 sleeve portion 372 slider 373 preselector stop feature 374 spline feature 375 preselection indication 376 extension 377 gripping structure 379 pointer 381 surface section 382 surface section 383 interrupt 384 surface section 385 interrupt 390 position sensor 391 sensor section 392 sensor section 393 sensor section 400 add-on device 402 electric power source 410 display 412 display section 414 display section 415 indicator 420 processor 421 detector element 422 detector element 424 detector element 430 position sensor