TOUCH SENSITIVE LABEL FOR AN INJECTION DEVICE

Abstract

The present disclosure relates to a touch sensitive label for an injection device, the label comprising: —a flexible substrate (101) configured for attachment to a housing (10) of the injection device (1), —an electronic display (110) located on the substrate (101) and configured to visually display at least one indication (111), —a touch sensitive area (120) located on the substrate (101) and electrically connectable to the electronic display (110), —a processor (140) connected to the electronic display (110) and configured to modify the visual appearance of the at least one indication (111) in response to a user touching or depressing the touch sensitive area (120).

Claims

1. A touch sensitive label for an injection device, the label comprising: a flexible substrate (101) configured for attachment to a housing (10) of the injection device (1), an electronic display (110) located on the substrate (101) and configured to visually display at least one indication (111), a touch sensitive area (120) located on the substrate (101) and electrically connectable to the electronic display (110), a processor (140) connected to the electronic display (110) and configured to modify the visual appearance of the at least one indication (111) in response to a user touching or depressing the touch sensitive area (120).

2. The label according to claim 1, further comprising an electronic circuit (130) located on the substrate (101), electrically connected to the touch sensitive area (120) and electrically connected to the electronic display (110) and to the processor (140).

3. The label according to claim any one of the preceding claims, wherein the touch sensitive area (120) is integrated into the electronic display (110).

4. The label according to claim 1 or 2, wherein the touch sensitive area (120) is located outside the electronic display (110).

5. The label according to any one of the preceding claims, wherein a lower side of the flexible substrate (101) at least in sections is provided with an adhesive (102).

6. The label according to any one of the preceding claims 2 to 5, wherein we electronic circuit (130) comprises a battery (150).

7. The label according to any one of the preceding claims 2 to 6, wherein the electronic circuit (130) comprises a data storage (144) configured to store at least one of a number of user activities and a point of time of a user activity.

8. The label according to any one of the preceding claims 2 to 7, wherein the electronic circuit (130) comprises an antenna (160) for wireless transmission of electronic signals with an external electronic device (200).

9. The label according to any one of the preceding claims 2 to 8, wherein the electronic circuit (130) comprises a sensor (170) configured to determine at least one of a position and or rotational state of at least one of a dose tracker (176) and a preselector (95) of the injection device (1) when the label (100) is attached to the injection device (1).

10. The label according to claim 9, wherein the sensor (170) comprises at least a first sensor segment (171) and a second sensor segment (172) arranged at a predefined distance from each other, wherein each of the first and second sensor segments (171, 172) is configured to detect a presence or position of an indicator (175) of one of the dose tracker (176) and the preselector (95).

11. The label according to claim 9 or 10, wherein the processor (140) is configured to generate at least one of a visual indication (111) and a visual confirmation (112) on the electronic display (110) if the determined longitudinal or rotational position of the dose tracker (176) matches with the predefined position, or if the determined longitudinal or rotational position of the dose tracker (176) does not match with the predefined position.

12. The label according to any one of the preceding claims 2 to 11, wherein the electronic circuit (130) comprises at least one printed electronic component.

13. The label according to any one of the preceding claims, wherein the electronic display (110) is one of an electrophoretic display and a thin-film electroluminescent display.

14. An injection device for setting and injecting of a dose of a medicament, the injection device comprising: a housing (10) configured to accommodate a medicament container (6), a drive mechanism (8) configured to withdraw or to expel a dose of the medicament from the medicament container (6) and configured to inject the dose of the medicament into biological tissue, a label according to any one of the preceding claims attached to the housing (10).

15. The injection device according to claim 14 further comprising the medicament container (6) arranged inside the housing (10).

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0142] In the following, numerous examples of the container and of an injection device will be described in greater detail by making reference to the drawings, in which:

[0143] FIG. 1 shows an example of an injection device,

[0144] FIG. 2 shows the injection device of FIG. 1 in an exploded perspective view,

[0145] FIG. 3 shows the injection device of FIG. 1 with a touch sensitive label attached to the housing of the injection device,

[0146] FIG. 4 is an isolated illustration of an example of the touch sensitive label,

[0147] FIG. 5 shows another example of the touch sensitive label,

[0148] FIG. 6 shows a further example of the touch sensitive label,

[0149] FIG. 7 shows the multilayer structure of the touch sensitive label,

[0150] FIG. 8 is a cross-section through an example of the touch sensitive label,

[0151] FIG. 9 is a block diagram illustrating the electronic circuit of the touch sensitive label,

[0152] FIG. 10 shows another example of the touch sensitive label equipped with a sensor,

[0153] FIG. 11 shows a cross-section through the injection device with the touch sensitive label attached thereto,

[0154] FIG. 12 shows a lower side of one example of the touch sensitive label of FIG. 10 and

[0155] FIG. 13 shows a flowchart representing various steps of using the touch sensitive label.

DETAILED DESCRIPTION

[0156] The injection device 1 as shown in FIGS. 1 and 2 is a pre-filled disposable injection device that comprises a housing 10 to which an injection needle 15 can be affixed. The injection needle 15 is protected by an inner needle cap 16 and either an outer needle cap 17 or a protective cap 18 that is configured to enclose and to protect a distal section of the housing 10 of the injection device 1. The housing 10 may comprise and form a main housing part configured to accommodate a drive mechanism 8 as shown in FIG. 2. The injection device 1 may further comprise a distal housing component denoted as cartridge holder 14. The cartridge holder 14 may be permanently or releasably connected to the main housing 10. The cartridge holder 14 is typically configured to accommodate a cartridge 6 that is filled with a liquid medicament. The cartridge 6 comprises a cylindrically-shaped or tubular-shaped barrel 25 sealed in proximal direction 3 by means of a bung 7 located inside the barrel 25. The bung 7 is displaceable relative to the barrel 25 of the cartridge 6 in a distal direction 2 by means of a piston rod 20. A distal end of the cartridge 6 is sealed by a pierceable seal 26 configured as a septum and being pierceable by a proximally directed tipped end of the injection needle 15. The cartridge holder 14 comprises a threaded socket 28 at its distal end to threadedly engage with a correspondingly threaded portion of the injection needle 15. By attaching the injection needle 15 to the distal end of the cartridge holder 14 the seal 26 of the cartridge 6 is penetrated thereby establishing a fluid transferring access to the interior of the cartridge 6.

[0157] 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 μg of pure crystalline insulin (1/22 mg). The dose dial 12 may comprise or may form a dose dial.

[0158] As shown further in FIGS. 1 and 2, the housing 10 comprises a dosage window 13 that may be in the form of an aperture in the housing 10. The dosage window 13 permits a user to view a limited portion of a number sleeve 80 that is configured to move when the dose dial 12 is turned, to provide a visual indication of a currently set dose. The dose dial 12 is rotated on a helical path with respect to the housing 10 when turned during setting and/or dispensing or expelling of a dose.

[0159] 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.

[0160] 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.

[0161] 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.

[0162] 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.

[0163] An example of the drive mechanism 8 is illustrated in more detail in FIG. 2. It comprises numerous mechanically interacting components. A flange like support of the housing 10 comprises a threaded axial through opening threadedly engaged with a first thread or distal thread 22 of the piston rod 20. The distal end of the piston rod 20 comprises a bearing 21 on which a pressure foot 23 is free to rotate with the longitudinal axis of the piston rod 20 as an axis of rotation. The pressure foot 23 is configured to axially abut against a proximally facing thrust receiving face of the bung 7 of the cartridge 6. During a dispensing action the piston rod 20 rotates relative to the housing 10 thereby experiencing a distally directed advancing motion relative to the housing 10 and hence relative to the barrel 25 of the cartridge 6. As a consequence, the bung 7 of the cartridge 6 is displaced in distal direction 2 by a well-defined distance due to the threaded engagement of the piston rod 20 with the housing 10.

[0164] 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.

[0165] 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.

[0166] 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.

[0167] 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.

[0168] 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 there between. The dose dial 12 is provided with a central opening.

[0169] 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.

[0170] 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 to prevent further movement in a first sense of rotation, e.g. 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.

[0171] 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.

[0172] 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. Here, the clutch may serve as a ratchet mechanism.

[0173] As an alternative or in addition the ratchet mechanism 90 may comprise at least one ratchet feature 91, such as a flexible arm on the sidewall of the tubular-shaped clutch 60. The at least one ratchet feature 91 may comprise a radially outwardly extending protrusion e.g. on a free end of the flexible arm. The protrusion is configured to engage with a correspondingly shaped counter ratchet structure on an inside of the number sleeve 80. The inside of the number sleeve 80 may comprise longitudinally shaped grooves or protrusions featuring a saw-tooth profile. During dialing or setting of a dose the ratchet mechanism 90 allows and supports a rotation of the number sleeve 80 relative to the clutch 60 along a second sense of rotation 5, which rotation is accompanied by a regular clicking of the flexible arm of the clutch 60. An angular momentum applied to the number sleeve 80 along the first sense of rotation for is unalterably transferred to the clutch 60. Here, the mutually corresponding ratchet features of the ratchet mechanism 90 provide a torque transmission from the number sleeve 80 to the clutch 60.

[0174] 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.

[0175] 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.

[0176] 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.

[0177] 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.

[0178] The dose setting mechanism 9 as illustrated in FIG. 2 comprises at least the dose dial 12 and the number sleeve 80. As the dose dial 12 is rotated during and for setting of a dose the number sleeve 80 starts to rotate relative to the housing along a helical path as defined by the threaded engagement of its outer thread or helical groove 81 with a correspondingly shaped threaded section at the inside surface of the housing.

[0179] 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 first sense or rotation or 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 second sense of rotation, hence in a dose decrementing direction 5, e.g. counterclockwise.

[0180] In FIGS. 3-9 one example of a touch sensitive label 100 configured for attachment to the housing 10 of the injection device 1 is illustrated. As indicated in FIG. 3 the label 100 is attachable to a sidewall of the housing 10. The touch sensitive label comprises a flexible substrate 101 as shown in FIG. 7 carrying an electronic display 110. The electronic display 110 is located on an upper side of the substrate 101. The electronic display 110 may be formed by a multilayer structure as indicated in FIGS. 7 and 8. The electronic display 110 and/or the touch sensitive label 100 may thus comprise a multilayer structure, e.g. a thin film multilayer structure.

[0181] The flexible substrate 101 is foldable or bendable around the circumference of the housing 10, which might be tubular shaped. The flexible substrate 101 and hence the entire touch sensitive label 100 may be adhesively attached to the sidewall of the housing 10 and may thus wrap around at least a portion of an outside surface of the housing 10.

[0182] The flexible substrate 101 or base substrate may be any material known for producing printed electronic labels, such as PET film or office paper. Other plastic materials are also feasible, e.g. PVC. The base substrate has an adhesive on one side to fix the label to a pen body, e.g. either permanently or removeably, depending on the choice of adhesive.

[0183] The touch sensitive label 100 comprises an electronic display 110 and a touch sensitive area 120. In the examples of FIGS. 4-6 the touch sensitive area 120 is a dedicated area of the surface of the electronic display 110. Here, the touch sensitive area 120 is integrated into the electronic display 110. The electronic display 110 may be a touch sensitive display. The electronic display 110 is configured to visually display at least one indication 111. In the present examples the at least one indication 111 may be a number or any other symbol thus representing a size of a dose to be set and injected by the injection device 1.

[0184] The touch sensitive label 100 comprises a flexible structure. The touch sensitive label 100 is bendable or wrappable around an outer circumference of the housing 10 of the injection device 1. The electronic display 110 is a flexible display. It may comprise one of an electrophoretic display and a thin film electroluminescent display. Such displays are known to be flexible and/or bendable. They are therefore configured to become wrapped around the outer circumference of the housing 10 of the injection device 1. The display 110 is at least configured to visually illustrate the indication 111.

[0185] The touch sensitive label 100 further comprises a touch sensitive area 120. In the example of FIG. 4 the touch sensitive area 120 coincides and entirely overlaps with the electronic display 110. In another example as illustrated in FIG. 5 the touch sensitive area 120 is located inside the electronic display 110. The touch sensitive area 120 is a portion of the electronic display 110. Here, the touch sensitive area 120 is a touch sensitive part of the electronic display 110. Portions or sections of the electronic display 110 located outside the touch sensitive area 120 may be touch insensitive.

[0186] The touch sensitive area could comprise capacitive switches produced in printing electronics technology. For instance a sensor element can be designed as an electrode which is part of a capacitor. The capacitor can be “detuned” when an object, such as a finger approaches and comes in close vicinity to the capacitor. This approach has an influence on a measurable property of the capacitor, e.g. on the capacitance thereof.

[0187] In the example of FIG. 3 the touch sensitive area 120 is located outside the electronic display 110. It is located on the same side of the substrate 101. Both the touch sensitive area 120 and the electronic display 110 are located on the upper side of the substrate 101. In the example of FIG. 3 the touch sensitive area 120 may comprise a touch sensitive button or a mechanical switch. Upon touching or depressing the touch sensitive area 120, i.e. the switch, an electronic circuit 130 as for instance illustrated in FIG. 9, can be manipulated accordingly. There, the touch sensitive area 120 comprises a mechanical switch 154 configured to interrupt a connection between a battery 150 and a processor 140. In other examples the switch 154 may electrically connect or disconnect the electronic display 110 with of from the processor 140 and/or with or from the battery 150.

[0188] The touch sensitive area 120 as well as the mechanical switch 154 may be exclusively connected to the processor 140. They may be located and arranged remote from the electrical connection between the battery 150 and the processor 140.

[0189] The example of an electronic circuit 130 of FIG. 9 is by no way limiting for the examples of FIGS. 3-8. The electronic display 110 may superimpose the electronic circuit 130. Hence, the electronic display 110 may entirely overlap with the electronic circuit 130 located underneath. The electronic display 110 may comprise a multilayer structure as indicated in FIGS. 7 and 8. The electronic circuit 130 may be implemented in one or several of the various layers 103, 104, 105, 106 of the flexible label 100. Typically, the electronic circuit 130 is entirely provided by a conductive layer 103.

[0190] The touch sensitive area 120 may be visually indicated on the electronic display 110 or on a separate portion outside the electronic display 110. As illustrated in FIGS. 5 and 6 the touch sensitive area 120 may comprise a button shape, e.g. a circular symmetric structure. Alternatively the touch sensitive area 120 may be rectangular or of polygonal shape.

[0191] The touch sensitive area 120 is connected to the electronic display 110. The touch sensitive area 120 and the electronic display 110 are configured to interact in such a way, that upon touching or depressing of the touch sensitive area 120 the electronic display 110 changes its mode of operation. The electronic display 110 may be switchable between a default mode, e.g. illustrated in FIG. 4 and an activated mode, e.g. illustrated in FIG. 6. In the default mode the electronic display 110 may be configured to illustrate a default or predefined size of a dose by visually illustrating the at least one indication 111.

[0192] Upon touching or depressing the touch sensitive area 120 as illustrated in FIG. 5 the electronic display 110 may be configured to illustrate a confirmation 112 or other pictogram. Alternative or in addition to the illustration of the confirmation 112 the electronic display 110 may be configured to change its visual appearance. It may be configured to enhance contrast or brightness such as to indicate to a user, that the touching or depressing of the touch sensitive area 120 has been detected and recognized. When the electronic display 110 is a multicolor display it may change color in response to a touching or depressing operation of the touch sensitive area 120. Here, a background illumination of the electronic display 110 may change. Alternative, at least one of the indication 111 and/or confirmation 112 may change its color.

[0193] With other examples, the style of a visual appearance of at least one of the indication 111 and confirmation 112 may be subject to a change in response to a touching or depressing operation of the touch sensitive area 120. For instance, at least one of the indication 111 and confirmation 112 may be subject to a change with regard to brightness, font type, color, size and combinations thereof.

[0194] In additional or further alternatives, the position of the indication (e.g. dose value “10”) may change on the display. E.g. upon activating the touch sensitive area the indication “10” may move from one side of the display (e.g. the left side) to the other side of the display (e.g. the right side). This change of position may indicate and prompt to a user that touching of the touch sensitive area was detected and processed.

[0195] In a further example and upon touching depressing of the touch sensitive area the processor may be configured to record a user activity and/or a point of time of a user activity in the data storage or memory of the electronic circuit. The storage may comprise capacity to store data relating to a plurality of events including time stamps, e.g. 30, 100, 1000 events.

[0196] In a further example the electronic circuit comprises an antenna providing a data transmission element, e.g. enabling NFC data transmission. This way data stored in the memory can be read out by an external device using NFC communication. NFC communication could be implemented in passive or active way, wherein the latter requires an energy source, e.g. battery, powering the electronics. The battery may be implemented in printing technology.

[0197] With an alternative example the electronic display 110 may be configured to switch off temporally so as to show a blank screen in response to the touching of the touch sensitive area 120. Even though the electronic display 110 may be switched into the activated mode by touching or depressing the touch sensitive area 120 it may provide a blank or void screen in which even the indication 111 previously illustrated during the default mode disappeared. In this activated mode the electronic display 110 may be configured to switch back or to return into the default mode after lapse of a predefined time interval. This predefined time interval may coincide or may correspond to a time interval between successive injection procedures of injection therapy. In other words as soon as the electronic display 110 returns into the default mode and visually illustrates the at least one indication 111 this is a clear indication for the user, that injection of a next dose of the medicament is currently due.

[0198] With such an example the touch sensitive label 100 is optionally equipped with a clock, e.g. implemented in a processor 140 of the electronic circuit 130. The clock basically enables counting of a predefined time interval, thus the time interval between two consecutive touching instances of the touch sensitive area 120.

[0199] The processor 140 and the electronic display 110 may be further configured to automatically switch from a default mode into an alert mode, e.g. when setting and injecting of a next dose should be overdue. In the alert mode the electronic display 110 may provide enhanced contrast and/or enhanced brightness compared to the default mode. In addition and in the alert mode the processor 140 and the electronic display 110 may be configured to visualize an alert signal thus indicating to the user, that setting and injecting of the proceeding dose of the medicament is currently overdue. In the alert mode, the electronic display 110 may be subject to a regular change of its visual appearance. It may regularly or irregularly modify at least one of the following parameters: brightness, contrast, color. Moreover, the at least one indication 111 answers or confirmation 112 may be subject to a regular or irregular modification. In the aloes mode, the electronic display 110 may provide a blinking or flickering effect thus attracting the user's attention.

[0200] FIG. 9 shows one example of an electronic circuit 130 of the touch sensitive label 100. The electronic circuit 130 may be directly printed on the flexible substrate 101. The electronic structures and/or the conductive structures of the electronic circuit 130 might be bendable or flexible as well. The integrity or functionality of the electronic circuit 130 is substantially unaffected by a bending or flexing of the flexible substrate 101 and/or of the electronic circuit 130.

[0201] The electronic circuit 130 comprises a battery 150 typically equipped with numerous battery cells 152. The individual battery cells 152 are electrically connected. They may be connected in series or parallel depending on the voltage provided by the individual battery cells 152 and depending on the voltage required by the processor 140. The battery 150 and/or its battery cells 152 may comprise a printed electronic structure. Hence, the battery 150 and/or the battery cells 152 our printed batteries or battery cells and may be arranged on the substrate 101 by way of printing.

[0202] The processor 140 is connected to the battery 150 as well as to the electronic display 110. The interconnection between the battery 150 and the processor 140 may be interrupted by the switch 154 located in the touch sensitive area 120. Depressing of the switch 154 may either connect or disconnect the electrical connection between the battery 150 and the processor 140. The processor 140 is further connected to the electronic display 110. The graphical representation on the electronic display 110, e.g. various display segments or pixels of the electronic display 110 may be individually activated or deactivated by the processor 140.

[0203] The processor 140 comprises a central processing unit (CPU) 142 and a storage 144. In the storage numerous predefined indications 111 may be stored, which upon registration of a closing or opening of the switch 154 might be illustrated on the electronic display 110. When equipped with a data storage 144 the processor 140 may be further configured to count a number of touch operations of the touch sensitive area 120. Every time a user uses the injection device 1 and depresses or touches the touch sensitive area 120 this touching or depression may be registered and counted in the storage 144. If the processor 140 is further equipped with a clock every touch instant can be further assigned with a timestamp thus allowing to record a dosing history or to record the points in time at which the touch sensitive area 120 was appropriately touched by the user of the injection device 1.

[0204] Even though the touch sensitive area 120 is illustrated offset or remote from the electronic display 110 in FIG. 9 there might be examples wherein the electronic display 110 overlaps with the touch sensitive area 120 or wherein the entire electronic display 110 is touch sensitive. With such examples the touch sensitive area 120 and the electronic display 110 may entirely or at least partially overlap.

[0205] The electronic circuit 130 may further comprise an antenna 160 connected to the processor 140. The antenna 160 may be configured for wireless data transmission. The antenna 160 may be configured as a receiving antenna and/or as a broadcasting antenna. The antenna 160 may be configured to transmit electromagnetic signals in the RF frequency band. The antenna 160 may comprise an RFID antenna. The antenna 160 may be configured in accordance to conventional wireless communication standards, such as Bluetooth, NFC or IEEE 802.11 (WLAN). The antenna 160 is configured to exchange data with an external electronic device 200, such as a smart watch, a smartphone, a tablet computer or a personal computer.

[0206] The processor 140 may be reconfigurable by signals obtained from the external electronic device 200 via the antenna 160. In this way the external electronic device 200 can be used to modify or to reconfigure the processor 140 and hence to modify and to reconfigure the content of the electronic display 110. In addition or alternative the external electronic device 200 may be further configured to read out the data storage 144 of the electronic circuit 130. In this way the dosing history and the use of the touch sensitive label 100 can be precisely monitored and transmitted to the external electronic device 200 for further processing and/or evaluation.

[0207] The entirety of the electronic components of the electronic circuit 130, e.g. the wired connections between the battery 150 and the battery cells 152, the switch 154 or the touch sensitive area 120, the antenna 160 as well as the processor 140 may comprise or may be formed by a printing process on the substrate 101. In this way a separate assembly and arrangement of numerous electronic components on the substrate 101 becomes substantially superfluous. This enables a cost efficient mass manufacturing of the touch sensitive label 100.

[0208] A lower side of the substrate 101 may be provided with an adhesive. The adhesive may be provided on an adhesive layer 102 entirely or at least partially covering the lower side of the substrate 101 located opposite to the conductive layer 103 on which the electronic circuit 130 is located. In FIG. 8 a stack of numerous layers 103, 104, 105, 106 configured to form the electronic display 110 is exemplary illustrated. The stack structure of FIG. 8 represents a thin film electroluminescent display 110. The substrate 101 may be pliable and may comprise or consist of one of the following: foldable office paper, transparent or non-transparent PET film, leather, wood, ceramics, and a metal foil. The electroluminescent display is configured to actively emit light.

[0209] A segment of the display consists of two overlaid electrodes that act as a capacitor. The oppositely located electrodes are provided in the conductive layer 103 and in the transparent electrode layer 106. Between these layers 103, 106 there is provided a dielectric layer 104 and an electroluminescent layer 105, e.g. in form of a phosphor layer. If a suitable voltage and a suitable current AC signal is applied the electroluminescent layer 105 emits photons.

[0210] The stack of layers 103, 104, 105, 106 may add only 100-150 μm of thickness to the substrate 101. In this way the electronic display 110 can be extraordinarily thin.

[0211] With other examples the flexible electronic display 110 is implemented as an electrophoretic display that is based on rearranging charged pigment particles by means of an applied electric field. There, titanium dioxide particles of appropriately 1 μm in diameter may be dispersed in a hydrocarbon oil. A dark colored dye is added to the oil along with surfactants and charging agents that cause the particles to take on an electric charge. This mixture is placed between two parallel, conductive plates separated by a gap of 10-100 μm. When a voltage is applied across the two plates the particles migrate electrophoretically to the plate that bears the opposite charge from that on the particles.

[0212] When the particles are located at the front or a viewing side of the display, it appears white because light is scattered back to the viewer by the high index titania particles. When the particles are located at the rear side of the display it appears dark because the incident light is absorbed by the colored dye. If the rear electrode is divided into a number of small picture elements or pixels, an image can be formed by applying the appropriate voltage to each region of the display to create a pattern of reflecting and absorbing regions. Electrophoretic displays are considered prime examples of an electronic paper category because of their paperlike appearance and lower power consumption.

[0213] The touch sensitive label 100 may only be optionally equipped with an antenna 160. With one implementation the label 100 may be void of an antenna 160 and may be operable to illustrate a well-defined or predefined indication 111 and to provide a switching between the default mode, the activated mode and/or the alert mode, e.g. in response to the touching or depressing of the touch sensitive area 120.

[0214] In FIGS. 10-12 there is illustrated a further example of the touch sensitive label 100. This label 100 may be implemented with or without an antenna 160. It comprises a flexible substrate 101 with the electronic display 110 and the touch sensitive area 120. Typically, the label 100 of FIG. 10 also comprises a processor 140, a CPU 142, a data storage 144 and a battery 150 as described above in connection with FIG. 9. In addition to the examples as described above in connection with FIGS. 3-9 the label 100 of FIGS. 10-12 further comprises a sensor 170.

[0215] The sensor 170 is configured to allocate or to determine a position and/or a rotational state of at least one of a dose tracker 176 and a preselector 95 of the injection device 1 when the label 100 is attached to the housing 10 in a predefined manner. For this the housing 10 may comprise at least one or several position marks 180 illustrated in FIG. 11 as protrusions on the outside surface of the housing 10. The label 100 has to be properly attached to the housing 10 in the area as defined by the at least one or several position marks 180. The dose tracker 176 may coincide with the number sleeve 80 of the injection device 1 or may be formed by the number sleeve. The dose tracker 176 comprises an indicator 175 whose positional state, i.e. the longitudinal position and/or a rotational orientation relative to the housing 10 is detectable by the sensor 170.

[0216] The preselector 95 schematically illustrated in FIG. 2 may be one of slidably or rotationally movable relative to the housing 10. It may be slidably or rotationally connected to the sidewall of the housing 10. The preselector 95 is movable between at least two discrete positional states, each of which defining and limiting a path length along which the dose tracker 176 is displaceable during setting of a dose. The preselector 95 is at least one of longitudinally or rotationally displaceable between a first stop position and a second stop position. Each stop position it is at least releasably fixable to the housing. The preselector 95 typically comprises a preselector stop feature to engage with a correspondingly shaped tracking stop feature of the dose tracker 176. The dose tracker 176 is displaceable in a dose incrementing direction until tracking stop feature engages the preselector stop feature. A further rotation or movement of the dose tracker beyond this engagement position is hindered and blocked by the preselector 95.

[0217] In the presently illustrated examples only the dose tracker 176 comprises an indicator 175 whose position is detectable by the sensor 170. The preselector 95 may be equally equipped with the indicator 175 configured to interact with the sensor 170. With one example of the touch sensitive label 100 only the preselector 95 is equipped with the indicator 175 and the dose tracker 176 is void of the indicator 175.

[0218] With other examples both, the preselector 95 and the indicator dose tracker 176 are each equipped with an own indicator 175. The indicator of the dose tracker 176 may distinguish from the indicator of the preselector 95. The sensor 170 may be configured to distinguish between the indicator of the dose tracker 176 and the indicator of the preselector 95. The sensor 170 and/or the processor 140 may be thus configured to determine both, a positional state of the dose tracker 176 and the preselector 95.

[0219] The position mark 180 may protrude from the sidewall of the housing 10 or may comprise a recess in the housing 10. Alternative, the position mark 180 may be void of protrusions or recesses in the outside surface of the housing 10. The position mark 180 may simply comprise a visual indication, such as a border region inside which the label 100 should be adhesively attached.

[0220] In one example the sensor 170 comprises numerous discrete sensor segments 171, 172, 173 that are separated along a moving direction of the indicator 175 and/or of the dose tracker 176 relative to the housing 10. As the dose tracker 176 is subject to a rotational and/or sliding movement relative to the housing 10 the indicator 175, e.g. initially overlapping with a first sensor segment 171 moves towards a second sensor segment 172 and, e.g. further towards the third sensor segment 173. The movement of the indicator 175 relative to the numerous sensor segments 171, 172, 173 is detectable by the sensor 170 that is electrically connected to the processor 140. In this way, the processor 140 and the sensor 170 are configured to determine and to detect an actual position and/or rotational state of the indicator 175 and hence of the dose tracker 176 relative to the housing 10.

[0221] The position or rotational state of the dose tracker 176 unequivocally coincides with a size of a dose actually set by the injection device 1. In this way, the processor 140 may be configured to determine or to measure a size of a dose actually set with the injection device 1 when the label 100 is appropriately connected to the housing 10. The determined longitudinal or rotational position of the dose tracker may be thus compared with a predefined position, e.g. indicated by the indication 111 on the electronic display 110. The dose actually set with the injection device may be further illustrated through the dosage window 13.

[0222] The processor 140 and the electronic display 110 may be further configured to generate at least one of a visual indication 111 and a visual confirmation 112 on the electronic display 110 if the determined longitudinal or rotational position of the dose tracker 176 matches with a predefined position. Alternatively or additionally the processor may be configured to generate at least one of a visual indication 111 and a visual confirmation 112 on the electronic display 110 if the determined longitudinal or rotational position of the dose tracker 176 does not match with the predefined position.

[0223] Typically and as long as the determined longitudinal or rotational position of the dose tracker actually measured by the sensor 120 does not match with a predefined position or with a predefined size of a dose the processor is configured to generate a visual indication on the electronic display thus indicating to a user, that the size of the dose actually set is too large or too small. For this the electronic display 110 may be configured to generate a respective indication 111, e.g. in form of an arrow pointing into the respective direction along which the dose dial 12 has to be rotated until the size of the dose actually set and determined by the sensor 170 matches with a predefined size of a dose.

[0224] Alternative to the generation of dose size indicating symbols it is also conceivable that the electronic display 110 changes its visual appearance, e.g. in form of an abrupt enhancement of contrast and/or brightness. If the electronic display 110 is a multicolored display it may also change color when, e.g. a dose size actually measured matches with a predefined dose that should be set and injected by the injection device 1.

[0225] The specific implementation of the sensor 170 and the indicator 175 may vary. As illustrated in FIG. 11 the housing 10 may comprise a through opening 178 or a recess through which the position of the indicator 175 can be for instance mechanically or electrically detected, e.g. by means of numerous contact pins provided on each sensor segment 171, 172, 173. For this, there may be established a direct mechanical contact between the indicator 175 and at least one of the sensor segments 171, 172, 173. As schematically illustrated in FIG. 12 the lower side of the substrate 101 comprises a recess 108 through which the sensor segments 171, 172, 173 are accessible or through which the sensor segments 171, 172, 173 may reach.

[0226] Alternatively, the sensor segments 171, 172, 173 may slightly protrude from the lower side of the substrate 101 so as to reach through or into the through opening 178 or recess of the housing 10. If appropriately attached to the housing 10 the sensor segment 171 may be in electrical contact with the indicator 175 as shown in FIG. 12. The electrical contact between the sensor segment 171 and the indicator 175 may be detected by the sensor 170 and/or by the processor 140. As the indicator 175 and the dose tracker is subject to a movement, e.g. along the longitudinal direction of the recess 108 it may move away from the first sensor segment 171 and may slide or rotate past the second sensor segment 172. As further illustrated in FIG. 12 and when moved away from an initial position the indicator 175′ may be located between the second sensor segment 172 and a third sensor segment 173. There it may be in contact with both sensor segments 172, 173. This position may be detected by both of the segments 172, 173.

[0227] With other examples the indicator 175 may be magnetically encoded and the sensor segments 171, 172, 173 may be configured to detect a magnetic field of the indicator 175 as the indicator 175 is subject to a longitudinal and/or rotational movement. With a further example the indicator 175 and the sensor segments 171, 172, 173 may be implemented electrostatically. Here, the numerous sensor segments 171, 172, 173 may be configured to allocate or to detect a modification of an electric field induced by the indicator 175. Furthermore, the sensor segments 171, 172, 173 may comprise capacity measuring elements configured to measure a modification of an electric field or electric capacitance in the vicinity of the respective sensor segments 171, 172, 173. Magnetic, electrostatic and capacitive measurement procedures may be of particular benefit because they may not require a through opening 178 or recess in the sidewall of the housing 10. With such implementations the label 100 may be simply adhesively attached within the given position marks on the outside surface of the housing 10.

[0228] In FIG. 13 a flowchart is illustrative of a method of using the touch sensitive label. In a first step 300 the label 100 is attached to the injection device 1. The label 100 is typically attached to a sidewall 10 of the injection device 1. For this, a release sheet covering an adhesive layer 102 on the lower side of the substrate 101 is removed so to expose the adhesive layer 102. The substrate 101 and the entire label 100 may thus be folded around or wrapped around the sidewall of the housing 10, typically within a position mark 180.

[0229] After attaching the label to the injection device in step 300 a user may touch or depress the touch sensitive area 120 in step 302 to switch the label 100 form the default mode into the activated mode. In response to the touching or depression of the touch sensitive area 120 in step 302 in a following step 304 the label 100 actually switches from one of the default mode and the activated mode into the other one of the default mode at the activated mode. In effect, the electronic display 110 modifies its visual appearance. Optionally and in a further step 306 the electronic display 110 may return into the default mode when switched in the preceding step 304 from the default mode into the activated mode. Returning into the default mode in step 306 may be triggered autonomously by the processor 140 after lapse of a predefined time interval.

REFERENCE NUMBERS

[0230] 1 injection device [0231] 2 distal direction [0232] 3 proximal direction [0233] 4 dose incrementing direction [0234] 5 dose decrementing direction [0235] 6 cartridge [0236] 7 bung [0237] 8 drive mechanism [0238] 9 dose setting mechanism [0239] 10 housing [0240] 11 trigger [0241] 12 dose dial [0242] 13 dosage window [0243] 14 cartridge holder [0244] 15 injection needle [0245] 16 inner needle cap [0246] 17 outer needle cap [0247] 18 protective cap [0248] 19 protrusion [0249] 20 piston rod [0250] 21 bearing [0251] 22 first thread [0252] 23 pressure foot [0253] 24 second thread [0254] 25 barrel [0255] 26 seal [0256] 28 threaded socket [0257] 30 drive sleeve [0258] 31 threaded section [0259] 32 flange [0260] 33 flange [0261] 35 last dose limiter [0262] 36 shoulder [0263] 40 spring [0264] 41 recess [0265] 50 dose tracker [0266] 51 tracking stop feature [0267] 60 clutch [0268] 62 insert piece [0269] 64 stem [0270] 80 number sleeve [0271] 81 groove [0272] 90 ratchet mechanism [0273] 91 ratchet feature [0274] 95 preselector [0275] 100 label [0276] 101 substrate [0277] 102 adhesive layer [0278] 103 conductive layer [0279] 104 dielectric layer [0280] 105 electroluminescent layer [0281] 106 transparent electrode layer [0282] 108 recess [0283] 110 electronic display [0284] 111 indication [0285] 112 confirmation [0286] 120 touch sensitive area [0287] 130 electronic circuit [0288] 140 processor [0289] 142 CPU [0290] 144 data storage [0291] 150 battery [0292] 152 battery cell [0293] 154 switch [0294] 160 antenna [0295] 170 sensor [0296] 171 sensor segment [0297] 172 sensor segment [0298] 173 sensor segment [0299] 175 indicator [0300] 176 dose tracker [0301] 178 through opening [0302] 180 position mark [0303] 200 external electronic device