DRUG DELIVERY DEVICE AND MODULE HEREWITH

Abstract

A drug delivery device comprises a dose setting and driving assembly for dialing and dispensing a dose of a medicament from a cartridge of the drug delivery device. The dose setting and driving assembly includes an outer housing, a number sleeve and a dose dial grip. The number sleeve and the dose dial grip are rotatable relative to the outer housing during dose dialing. The number sleeve is rotatable relative to the outer housing during dose dispensing. The dose dial grip is axially displaceable and rotationally constrained to the outer housing during dose dispensing. The dose dial grip comprises an outer skirt partially protruding out of the outer housing and comprising a profiled gripping surface at the proximal end of the dose dial grip.

Claims

1-15. (canceled)

16. A drug delivery device, comprising: a dose setting and driving assembly for dialing and dispensing a dose of a medicament from a cartridge of the drug delivery device, the dose setting and driving assembly comprising an outer housing having an aperture or window and at least two contacts arranged within the outer housing; a number sleeve (i) disposed such that a portion of the number sleeve is visible through the aperture or window in the outer housing to display a dialed dose and (ii) configured to rotate relative to the outer housing during dose dispensing; and a dose dial grip comprising an outer skirt partially protruding out of the outer housing, the dose dial grip configured to (i) rotate relative to the outer housing during dose dialing, (ii) be axially displaceable relative to the outer housing during dose dispensing, and (iii) be rotationally constrained to the outer housing during dose dispensing, at least one of the number sleeve or the outer skirt of the dose dial grip comprising at least two circumferentially spaced conductive strips distributed around an outer circumference of the number sleeve or the outer skirt, wherein the at least two contacts are biased to abut the at least two conductive strips, and at least one of the at least two conductive strips or the at least two contacts are accessible from outside the outer housing.

17. The drug delivery device according to claim 16, wherein the at least two contacts form at least one reference element and the at least two conductive strips form a pattern, the at least two contacts and the at least two conductive strips together forming a detector arrangement comprising at least one electric sensor being operable to detect a positional variation of the pattern relative to the at least one reference element.

18. The drug delivery device according to claim 17, wherein the at least one electric sensor is operable to generate at least one electric signal in response to the positional variation of the pattern during a movement of at least one of the number sleeve or the outer skirt relative to the outer housing during dose dialing and dose dispensing.

19. The drug delivery device according to claim 18, wherein the pattern comprises a first pattern portion that is electrically conductive and a second pattern portion that is electrically insulating.

20. The drug delivery device according to claim 19, wherein the at least two contacts of the detector arrangement are operable to alternately connect to the first pattern portion and the second pattern portion of the pattern during the movement of at least one of the number sleeve or the outer skirt relative to the outer housing during dose dialing and dose dispensing.

21. The drug delivery device according to claim 20, wherein the pattern comprises a third pattern portion that is electrically conductive, the first pattern portion and the third pattern portion being electrically separated from each other.

22. The drug delivery device according to claim 21, wherein the detector arrangement and the at least one electric sensor are arranged on the outer circumference of the number sleeve or the outer skirt.

23. The drug delivery device according to claim 22, wherein the at least one electric sensor is electrically connected to the first pattern portion, the at least one reference element is arranged on the outer housing, and the at least one reference element comprises an electrical bridging contact configured to alternately establish and interrupt an electric contact between the first pattern portion and the third pattern portion during the movement of at least one of the number sleeve or the outer skirt relative to the outer housing during dose dialing and dose dispensing.

24. The drug delivery device according to claim 23, wherein the electrical bridging contact comprises a first electrical contact tap of the at least two contacts and a second electrical contact tap of the at least two contacts, the first electrical contact tap and the second electrical contact tap being electrically connected to each other.

25. The drug delivery device according to claim 24, wherein the first electrical contact tap and the second electrical contact tap are spatially separated from each other along a first separation direction parallel to a distance between the first pattern portion and the third pattern portion.

26. The drug delivery device according to claim 25, wherein the electrical bridging contact comprises a third electrical contact tap of the at least two contacts spatially separated from at least one of the first electrical contact tap and the second electrical contact tap along a second separation direction non-parallel to the first separation direction.

27. The drug delivery device according to claim 24, wherein the electrical bridging contact comprises a body made of sheet-metal and at least one flexible arm, wherein at least one of the first electrical contact tap or the second electrical contact tap are arranged at a free end of the at least one flexible arm.

28. The drug delivery device according to claim 16, wherein the at least two conductive strips are printed on the outer skirt of the dose dial grip.

29. The drug delivery device according to claim 16, wherein the at least two conductive strips are provided on an encoder wheel fixed to the number sleeve.

30. The drug delivery device according to claim 16, wherein the dose dial grip comprises at least one of a clip or a rotational alignment feature for attaching a separate module on the dose dial grip.

31. A module for detecting movement of at least one component of a drug delivery device, the module comprising: a microprocessor for at least one of processing or storing data from a detector arrangement of the drug delivery device; electrical connectors to releasably establish contact with conductive strips or contacts of the drug delivery device; and at least one of a clip or a rotational alignment feature for attaching the module on the drug delivery device.

32. The module according to claim 31, wherein the clip or the rotational alignment feature is configured to attach the module to a dose dial grip of the drug delivery device.

33. The module according to claim 31, wherein the electrical connectors comprise metal clips having a free end biased radially inwards for abutting the conductive strips or contacts of the drug delivery device.

34. The module according to claim 31, further comprising a cap shaped and sized to fit over a dose dial grip of the drug delivery device, the cap comprising an outer profiled gripping surface and encloses the microprocessor and the electrical connectors.

35. The module according to claim 34, wherein the cap is releasably attached to the dose dial grip of the drug delivery device.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0065] Non-limiting, exemplary embodiments of the disclosure will now be described with reference to the accompanying drawings, in which:

[0066] FIG. 1 shows a view of a drug delivery device according to a first embodiment of the disclosure without a module;

[0067] FIG. 2 shows the drug delivery device of FIG. 1 with a module attached;

[0068] FIG. 3 shows a view of a dose dial grip of the drug delivery device of FIGS. 1 and 2;

[0069] FIG. 4 shows a view of the proximal end of the drug delivery device of FIGS. 1 and 2 with the dose dial grip and number sleeve removed;

[0070] FIG. 5 shows a sectional view of the module of FIG. 2;

[0071] FIG. 6 shows a sectional view of the drug delivery device of FIGS. 1 and 2 with the module attached;

[0072] FIG. 7 shows a sectional view of a proximal part of a drug delivery device according to a second embodiment of the disclosure; and;

[0073] FIG. 8 shows a perspective partially cut away view on the drug delivery device of FIG. 7.

[0074] In the Figures, identical elements, identically acting elements or elements of the same kind may be provided with the same reference numerals.

DETAILED DESCRIPTION

[0075] The terms “axial”, “radial”, or “circumferential” as used herein may be used with respect to a main longitudinal axis I of the device, the cartridge, the housing or the cartridge holder, e.g. the axis which extends through the proximal and distal ends of the cartridge, the cartridge holder or the drug delivery device.

[0076] “Distal” is used herein to specify directions, ends or surfaces which are arranged or are to be arranged to face or point towards a dispensing end of the drug delivery device, i.e. the left side in FIGS. 1 and 2, or components thereof and/or point away from, are to be arranged to face away from or face away from the proximal end, i.e. the right end in FIGS. 1 and 2. On the other hand, “proximal” is used to specify directions, ends or surfaces which are arranged or are to be arranged to face away from or point away from the dispensing end and/or from the distal end of the drug delivery device or components thereof. The distal end may be the end closest to the dispensing and/or furthest away from the proximal end and the proximal end may be the end furthest away from the dispensing end. A proximal surface may face away from the distal end and/or towards the proximal end. A distal surface may face towards the distal end and/or away from the proximal end. The dispensing end may be the needle end where a needle unit is or is to be mounted to the device, for example.

[0077] A first embodiment of a drug delivery device of the disclosure is depicted in FIGS. 1 to 6. The drug delivery device comprises an outer housing 1 and a cartridge holder 2 for retaining a cartridge comprising medicament. The cartridge holder 2 may be permanently or releasably attached to the outer housing 1.

[0078] The outer housing 1 is part of a dose setting and driving assembly further comprising at least a number sleeve 3 and a dose dial grip 4. A portion of the number sleeve 3 is visible through window 5 in the outer housing 1, thus providing a dose display. The dose dial grip 4 comprises an outer skirt 6 partially protruding out of the proximal end of the outer housing 1 and comprising a profiled gripping surface 7 at the proximal end of the dose dial grip 4. Preferably, the dose dial grip 4 is suitable for two different types of actuation, e.g. a rotation about the longitudinal axis I of the drug delivery device and a displacement parallel to the longitudinal axis I of the drug delivery device.

[0079] The dose setting and driving assembly may comprise further component parts, for example a driver 8 for driving a piston rod (not shown), a clutch 9 for coupling and decoupling the driver 8 and the number sleeve 3 and/or of the dose dial grip 4 to switch between a dose setting mode (dose dialing) of the drug delivery device and dose dispensing mode, and an inner housing (not shown). For example, the number sleeve 3 and the dose dial grip 4 may be rotatable relative to the outer housing 1 during dose dialing and the number sleeve 3 may be rotatable relative to the outer housing 1 during dose dispensing, while the dose dial grip 4 is axially displaceable and rotationally constrained to the outer housing 1 during dose dispensing. The number sleeve 3 may be in threaded engagement with a stationary component part, e.g. the inner housing, such that the rotation of the number sleeve 3 results in a helical displacement, i.e. a rotational movement combined with an axial movement. In the embodiment depicted in the Figures, the number sleeve 3 comprises a ring of radially outwards protruding clutch teeth 9 near its proximal end for engaging corresponding radially inwards protruding clutch teeth provided on the dose dial grip 4. This clutch 9 may be biased into engagement of the respective clutch teeth which may be disengaged by displacing the dose dial grip 4 relative to the number sleeve 3 by exerting a force on the proximal end face of the dose dial grip 4. In other words, with the clutch 9 engaged or coupled, the number sleeve 3 follows a rotation of the dose dial grip 4 upon actuation of a user. Further, with the clutch 9 disengaged or decoupled, the dose dial grip 4 may be displaced axially without rotation, while the number sleeve 3 follows this axial movement and is forced by the threaded engagement with the stationary component part to move on the helical path.

[0080] As shown in FIGS. 3 and 6 in more detail, the dose dial grip 4 may further comprise an inner stem 10 which is permanently constrained to the skirt 6 and the profiled gripping surface 7 in the depicted embodiment. As an alternative, the inner stem 10 may be integrally formed with the skirt 6 and the profiled gripping surface 7.

[0081] Further, the outer housing 1 may comprise a retention cap 11 which is permanently attached to the proximal end of the outer housing 1. The retention cap 11 may have the form of a ring or of the sleeve as shown in FIG. 4. Thus, the retention cap 11 and covers a portion of the dose dial grip 4. As an alternative to the retention cap 11 being a separate component part, the retention cap may be a unitary portion of the outer housing 1.

[0082] As shown in FIG. 3 in more detail, the skirt 6 of the dose dial grip 4 is provided with a series of electrically conductive strips 12, 13, 14 which may be printed, plated or etched on the outer cylindrical surface defined by the skirt 6. The electrically conductive strips are located space from the profiled gripping surface 7 of the dose dial grip 4 in the embodiment depicted in FIGS. 1 to 6. At least a portion of the strips 12 and 14 protrude from the proximal end of the outer housing 1 and/or of the retention cap 11 in the states depicted in FIGS. 1 and 2 in which the number sleeve 3 is in its most distal position, i.e. a position in which no dose is selected (dose size zero). As a higher dose is dialed by rotation of the dose dial grip 4 and the number sleeve 3, the strips 12 and 14 protrude further from the proximal end of the outer housing 1 and/or the retention cap 11. In addition, the strips 13 may protrude from the proximal end of the outer housing 1 and/or the retention cap 11 as a dose larger than zero is dialed. These conductive areas 12, 13, 14 comprise a ‘Live’ area, two ‘Sensor’ areas and a ‘0U switch’ area, forming a 2-bit rotational quadrature encoder with end-of-dose 0U switch.

[0083] Further, an electrically conductive element 15 comprising a series of contacts (contact tabs) 164, 166 and 168 is arranged within the outer housing 1 and/or the retention cap 11 to form bridging contacts as a reference. In the depicted embodiment the conductive element 15 is fully retained within the outer housing 1 and/or the retention cap 11. The series of contacts is arranged within the outer housing 1 biased to abut the conductive strips 12, 13, 14. The conductive strips and the conductive element 15 with its contact tabs form of an encoder assembly for recording doses that are dialled and delivered from the drug delivery device. The conductive bridging contacts or tabs of element 15 are mounted within the device housing 1 to alternately couple and de-couple ‘Live’ strips to ‘Sensor’ strips as the dose dial grip 4 rotates. These bridging contacts are not electrically connected to the module which will be explained below or its PCB, and act only to provide a conductive path between adjacent strips 12, 13, 14 on the skirt 6. The bridging contacts are rotationally and axially aligned within the outer housing 1 and can be retained with the retention cap 11. Preferably, the encoder assembly is based on the working principle as disclosed in WO 2020/127006 A to which reference is made regarding the disclosure of the encoder functions.

[0084] The module 20 for detecting movement of at least one component part of the drug delivery device, is depicted in FIGS. 5 and 6. In FIG. 6, the module 20 is attached to the drug delivery device, specifically to the proximal end of the dose dial grip 4 and may comprise an outer profiled gripping surface.

[0085] In the depicted example, the module 20 comprises a microprocessor 21 for processing and/or storing data from a detector arrangement of the drug delivery device. Further, the module 20 comprises electrical connectors 22 to releasably establish contact with at least some of conductive strips 12, 13, 14 of the drug delivery device and mechanical fixation means, e.g. clip features 23, for attaching the module 20 on the drug delivery device. The module 20 further comprises a power supply for the microprocessor 21, for example in the form of a coin cell 24. The microprocessor 21, the connectors 22 and the coin cell 24 are received in a cap-like housing 25 which may be provided with a separate end cap 26 as depicted in FIGS. 5 and 6. As an alternative, the end cap 26 may be a unitary part with the housing 25. In addition to the clip features 23, rotational alignment means 27 may be provided in or on the housing 25 for aligning the housing 25 mechanically with the dose dial grip 4, specifically the profiled gripping surface 7. The module 20 may be mechanically dedicated to fit to the drug delivery device in the correct orientation using poka-yoke features, which may be alignment features 27.

[0086] The module 20 is preferably a re-usable clip-on module configured to fit onto the dose dial grip 4. Electrical connections are made to at least some of the conductive strips 12, 13, 14 of the skirt 6 using metallic contacts of the connectors 22, which act as inputs to a micro-controller, allowing rotational de-coding. These metallic contacts of the connectors 22 are designed to deflect radially outwards when the module 20 is assembled to the drug delivery device, such that when the module is attached to the device, the metallic contacts are biased radially against the conductive areas formed by the conductive strips 12, 13, 14 of the skirt 6, ensuring good electrical connection.

[0087] The microprocessor 21 of the module 20 may be provided on a rigid PCB and can be configured to communicate via NFC or Bluetooth with a smart device for logging and recording insulin doses dialled with and/or dispensed from the drug delivery device.

[0088] In the following, the detection of movements in the drug delivery device by means of the module 20 is described in more detail.

[0089] On the outer surface of the tubular-shaped skirt 6, at least one pattern is provided by the electrically conductive strips 12, 13, 14. The pattern comprises a first pattern section 120, a separation 121 and a second pattern section 122. The first pattern section 120 extends almost over the entirety of the longitudinal elongation of the skirt 6 of the dose member 4. The second pattern section 122 is located at or near a proximal end of the skirt 6. The pattern comprises numerous pattern portions 110, 112, 114, 116. The pattern portions 110 are formed by the conductive strips 14 and are electrically conductive, while the pattern portions 112 are electrically insulating. The pattern portions 110, 112 comprise an elongated shape mainly extending parallel to the longitudinal axis of the drug delivery device. First and second pattern portions 110, 112 are arranged non-overlapping on the tubular-shaped surface of the skirt 6. These two pattern portions are suitable for detecting e.g. a rotation of the skirt 6 relative to the outer housing 1. Further pattern portions 114, 116 may be provided to detect additional movements, e.g. reaching an end position of the skirt 6 relative to the outer housing 1.

[0090] Optionally, the first and the second pattern portions 110, 112 may also distinguish from each other with regard to a radial position with regard to a central axis of the tubular-shaped skirt 6. For instance, the first pattern portion 110 may comprise one or several radial protrusions and the second pattern portion 112 may comprise one or several radial indentations. The radial protrusions and indentations may be provided on an outer tubular-shaped surface of the skirt 6.

[0091] At least one electric sensor is provided by the contact tabs 164, 166 and 168 in combination with the conductive strips 12, 13, 14. The at least one electric sensor is configured to distinguish between the first pattern portion 110 and the second pattern portion 112 if the respective pattern portions 110, 112 are in a defined region of coverage of the at least one electric sensor. As the first pattern portion 110 distinguishes by its electrical conductivity from the second pattern portion 112, the at least one electric sensor comprising the electric contact tabs 164, 166 and 168 allow to generate varying electric signals as first and second pattern portions 110, 112 pass by the electric contact tabs 164, 166 and 168.

[0092] As mentioned above, the pattern is not limited to only a first pattern portion 110 and a second pattern portion 112. There may be provided also a third pattern portion 114 and a fourth pattern portion 116 as shown in FIG. 3 and numerous further pattern portions that distinguish from each other, thus allowing to implement not only a 2-bit pattern but supporting a 3-bit, 4-bit, 5-bit, 6-bit or even n-bit pattern, with n being an integer number larger than 0. The type of pattern, hence the type of first and second pattern portions 110, 112 provided in the first pattern section 120 and provided in the second pattern section 122 may be substantially equal. However, the pattern and the pattern portions 110, 112 of the first pattern section 120, in particular their geometry, shape and orientation may distinguish from respective pattern portions 110, 112 provided in the second pattern section 122.

[0093] The working principle of this 2-bit encoding with a supplemental zero dose position detection is based on the bridging contact 15 being fixedly connected to the outer housing 1 and arranged at an inside tubular-shaped sidewall of the housing 1 or the retention cap 11. As illustrated in more detail in FIG. 4, the bridging contact 15 comprises three contact tabs 164, 166, 168 located at a longitudinal and hence at a free end of respective flexible arms. All arms as well as the respective contact tabs 164, 166, 168 are electrically interconnected. The bridging contact 15 may comprise a piece of sheet metal.

[0094] As schematically illustrated the first contact tap 164 and the second contact tap 166 are separated from each other along a first separation direction D1. The first separation direction D1 may coincide with the tangential or circumferential direction of the tubular-shaped pattern. The first and the second contact tabs 164, 166 may be arranged at the same longitudinal position. The third contact tap 168 is located at a longitudinal distance from at least one of the first and second contact tabs 164, 166. It is typically separated in longitudinal direction along the second separation direction D2 from both of the first and the second contact tabs 164, 166. The contact tabs 164, 166, 168 are integrally formed in the flexible arms and may each comprise radially inwardly protruding embossed portions. The contact tabs 164, 166, 168 may comprise a partially dome-shaped structure and may thus protrude radially inwardly from the rather planar-shaped surface of the flexible arms. In this way, and due to the non-negligible radial protrusion of the contact tabs 164, 166, 168 there may be provided a good and reliable mechanical and hence electrical contact between the contact tabs 164, 166, 168 and the electrically conductive structures, hence with numerous pattern portions 110, 114, 116 of the pattern of the skirt 6. Typically, the flexible arms and the radial protrusion of the respective contact tabs 164, 166, 168 provide a kind of a radial preload as the skirt 6 is arranged inside the hollow tubular-shaped outer housing 1 or the retention cap 11.

[0095] During dose setting and dose dispensing, the skirt 6 of the dose dial grip 4 is subject to a sliding motion relative to the outer housing 1 and hence relative to the bridging contact 15. In the configuration of FIGS. 1, 2 and 6, the skirt 6 is located close to a zero dose position but has not yet reached this zero dose position. Here, the first pattern portion 110 is in electrical contact with the third pattern portion 114 via the bridging contact 15. In this configuration the third contact tap 168 is located in the first pattern section 120. Hence, it is located distally from the separation 121.

[0096] Now, and as the skirt 6 approaches and reaches the zero dose configuration relative to the outer housing 1 and hence relative to the reference element the third contact tap 168 has traversed the separation 121 and comes into electrical contact with the fourth pattern portion 116 while the first contact tap 164 remains in electrical contact with the third pattern portion 114. In this way, the supply voltage present on the third pattern portion 114 is provided also to the fourth pattern portion 116. The input terminal of the detector arrangement is then tied to the supply voltage and switches from a logical 0 to a logical 1 as the zero dose configuration has been reached. In this way, the zero dose position of the skirt 6 relative to the outer housing 1 can be precisely detected at the end of a dose dispensing procedure.

[0097] The core encoding principle as depicted in the embodiment of FIGS. 1 to 6 is based on a series of conductive strips 12, 13, 14 formed on the outside diameter of the dose dial grip 4. The rotation of this component is encoded by electrically connecting the conductive strips 12, 13, 14 to the input of a microcontroller 21 by means of the connectors 22 of the module 20. Bridging contacts 164, 166, 168 mounted e.g. in the housing 1 selectively connect and disconnect conductive strips 12, 13, 14 on the dose dial grip 4, thereby alternating the signals received by the microcontroller.

[0098] The present disclosure relates to the combination of the electronic module 20 that can be embodied as a re-usable clip-on module with a suitably configured pen injector or drug delivery device for the purpose of recording doses that are dialed and delivered from the pen. This functionality may be of value to a wide variety of device users as a memory aid or to support detailed logging of dose history. It is possible that the module 20 is configured to be connectable to a mobile device, or similar, to enable the dose history to be downloaded from the module 20 on a periodic basis.

[0099] When the drug delivery device is operated without the addition of the clip-on module 20, the conductive strips 12, 13, 14 are passive. The clip-on module 20 connects electrically to these conductive strips 12, 13, 14 when fitted.

[0100] In summary, the additional elements required for a standard drug delivery device are three bridging contacts 164, 166, 168, conductive printing 12, 13, 14 on the dose dial grip 4 and, optionally, a retention cap 11. In certain markets where clip-on connectivity will not be required; it is possible to assemble devices without the bridging contacts or conductive printing.

[0101] A second embodiment is depicted in FIGS. 7 and 8. Again, the drug delivery device is provided with a dose setting and driving assembly comprising an outer housing 1, a number sleeve 3 and a dose dial grip 4. Instead of the conductive strips 12, 13, 14 on the dose dial grip 4, the number sleeve 3 is provided with an encoder wheel 29 having conductive and non conductive portions (contact/non-contact areas) distributed about the outer circumference of the encoder wheel 29. As shown in FIGS. 7 and 8, the encoder wheel 29 may be arranged at the proximal end of the number sleeve 3, for example proximally of the clutch teeth 9. Further, instead of the bridging contacts 15, at least two brushing contacts 30 are fixedly arranged as reference elements to enable quadrature encoding (direction detection) of the number sleeve 3.

[0102] The module 20 can be attached to and detached from the dose dial grip 4 in a similar manner as explained above with respect to the first embodiment. The module 20 comprises all electronic components, e.g. a battery 24, a processor 21, a transceiver, like NFC, BT, etc. (not shown) as well as the housing 25, an optional end cap 26 and a battery carrier 28. The interface between the drug delivery device and the module 20 comprises mechanical fixation means (e.g. snap in features) as described above. Electrical connection means may be provided between the module 20 and the brushing contacts 30, e.g. and the form of spring contacts.

[0103] Thus, in a similar manner as described with respect to the first embodiment, a drug delivery device may be equipped with low-cost “sensing” features, e.g. the encoder wheel 29 and the brushing contacts 30, such that the reusable clip-on electronic module 20 can be easily attached when desired, for example either at the production side or later by a HCP or a user.

TABLE-US-00001 Reference Numerals 1 (outer) housing 27 alignment feature 2 cartridge holder 28 battery carrier 3 number sleeve 29 encoder wheel 4 dose dial grip 30 brushing contact 5 aperture 6 skirt 110 first pattern portion 7 profiled gripping surface 112 second pattern portion 8 driver 114 third pattern portion 9 clutch (teeth) 116 fourth pattern portion 10 stem 11 retention cap 120 first pattern section 12 conductive strip 121 separation 13 conductive strip 122 second pattern section 14 conductive strip 15 bridging contact (reference element) 164 contact tab 20 module 166 contact tab 21 microprocessor 168 contact tab 22 connector 23 clip feature D1 first direction 24 coin cell (battery) D2 second direction 25 housing 26 end cap I longitudinal axis