A ROTARY DOSAGE SENSING MODULE FOR A DISPOSABLE DRUG DELIVERY PEN AND A METHOD OF ASSEMBLING THE SAME

Abstract

A dosage sensing module for or in a pen drug delivery device and a method of assembling the same. The module comprises a housing consisting of a first and second housing part, a power source unit, a processor unit and a dosage sensor unit with a first sensor part adapted to be fixed to a part not rotating during dose expelling and comprising a printed circuit board on which a pattern of individual electrical conductive sensor areas are arranged. The sensor unit further comprises a second sensor part adapted to be fixed to the piston rod to follow the rotation thereof during dose expelling. The second sensor part comprises individual structures that together with the conductive sensor areas are adapted to, upon relative rotational movement between the first and second sensor part, provide electrical signals to a processor unit indicative of the relative rotational position between the first and second sensor part.

Claims

1. A method of assembling a prefilled drug delivery device with an electronic rotary dosage sensing module for sensing the amount of drug being expelled from the delivery device, the device comprising a preassembled dosage engine part with a dose setting and expelling mechanism and a preassembled drug holding part with a drug-filled cartridge having a displaceable piston and an outlet, the dose expelling mechanism having a piston rod with a distal tip part to be rotationally and axially advanced in a direction towards said piston to displace the piston and thereby expel a dosage of drug from the cartridge through the outlet, when the delivery device is assembled, said electronic sensing module comprising; a first housing part, a second housing part, each housing part having attachment structure for attaching them to each other to form a single common sensing module house for at least partly housing; power source unit retaining structure for receiving and retaining a power source unit, a power source unit, a processor unit, a sensor unit comprising; a first sensor part comprising a printed circuit board having a first surface on which is disposed a plurality of individual electrical conductive sensor areas arranged in a pattern, a second sensor part arranged opposite to the first sensor part and adapted to be directly or indirectly attached to said distal tip part of the piston rod to thereby follow the rotation of the piston rod during dose expelling, the second sensor part comprising a plurality of electrically connected contact structures, and wherein the contact structures are adapted to, upon relative rotational movement between the first and second sensor part, electrically connect different individual electrically conductive sensor, each electrical connection generating an electrical signal to the processor unit being indicative of the rotational position between the first and second sensor part, and wherein the processor unit is adapted to process said signals to determine the amount of relative rotations between the first and second sensor part and thereby calculate the expelled dosage size based on the determined amount of relative rotations, and where the second housing part is adapted to engage said drug-filled cartridge and/or displaceable piston, when the delivery device is assembled, such that no rotation between the second housing part and drug-filled cartridge and/or piston is possible, wherein the method comprises the steps of; a) assembling the preassembled engine part and the first housing part by attaching the second sensor part to the distal tip part of the piston rod, b) positioning the power source unit in said power source unit retaining structure, c) attaching the second housing part to the first housing part via said attachment structure, and d) attaching said preassembled drug holding part to the preassembled engine part, such that the second housing part engages the drug-filled cartridge and/or piston.

2. The method according to claim 1, wherein the distal tip part of the piston comprises a central bore and a circumferential portion having one or more deflectable gripping arms, and wherein the second sensor part comprises a cylindrical part extending through an opening in the first housing part and having one or more protrusions located on an outer surface, and wherein step a) comprises moving said cylindrical part into said bore, whereby the deflectable gripping arms deflect over said protrusions and subsequently grip around said protrusions and provide a locked interconnection between the second sensor part and piston rod not allowing any relative rotation between the sensor part and the piston rod.

3. The method according to claim 1, wherein the first housing part, power source unit retaining structure, the processor unit, and the sensor unit is preassembled before performing step a).

4. The method according to claim 1, wherein the step of positioning the power source unit comprises moving the power source unit into the retaining structure in a direction perpendicular to the axis of rotation of the piston rod.

5. The method according to claim 1, wherein the step of positioning the power source unit comprises moving the power source unit into the retaining structure in a direction parallel to the axis of rotation of the piston rod.

6. The method according to claim 1, wherein the power source unit is a coin cell battery.

7. An electronic rotary dosage sensing module assembly for a prefilled drug delivery device comprising a dosage engine part with a dose setting and expelling mechanism and a drug holding part with a drug-filled cartridge having a displaceable piston and an outlet, the dose expelling mechanism having a piston rod with a distal tip part to be rotationally and axially advanced in a direction towards said piston to displace the piston and thereby expel a dosage of drug from the cartridge through the outlet, said module comprising; a first housing part, a second housing part, each housing part having attachment structure for attaching them to each other to form a single common sensing module house for at least partly housing; power source unit retaining structure for receiving and retaining a power source unit, a power source unit, a processor unit, a sensor unit comprising; a first sensor part adapted to be directly or indirectly fixed to a part of the delivery device not rotating during dose expelling and comprising a printed circuit board having a first surface on which is disposed a plurality of individual electrical conductive sensor areas arranged in a pattern, a second sensor part arranged opposite to the first sensor part and adapted to be indirectly or directly attached to said distal tip part of the piston rod to thereby follow the rotation of the piston rod during dose expelling, the second sensor part comprising a plurality of electrically connected contact structures, and wherein the contact structures are adapted to, upon relative rotational movement between the first and second sensor part, electrically connect different individual electrically conductive sensor areas, each electrical connection generating an electrical signal to the processor unit being indicative of the rotational position between the first and second sensor part, and wherein the processor unit is adapted to process said signals to determine the amount of relative rotations between the first and second sensor part and thereby calculate the expelled dosage size based on the determined amount of relative rotations, and where the second housing part is adapted to engage said drug-filled cartridge and/or displaceable piston, when the sensor module is inserted in drug delivery device, such that no rotation between the second housing part and drug-filled cartridge and/or piston is possible.

8. An electronic rotary dosage sensing module assembly for a prefilled drug delivery device comprising a dosage engine part with a dose setting and expelling mechanism and a drug holding part with a drug-filled cartridge having a displaceable piston and an outlet, the dose expelling mechanism having a piston rod with a distal tip part to be rotationally and axially advanced in a direction towards said piston to displace the piston and thereby expel a dosage of drug from the cartridge through the outlet, said module comprising; a first housing part, a second housing part, each housing part having attachment structure for attaching them to each other to form a single common sensing module house for at least partly housing; power source unit retaining structure for receiving and retaining a power source unit with a (−) and a (+) terminal for powering the sensing module, a power source unit, a processor unit, a sensor unit comprising; a first sensor part adapted to be directly or indirectly attached to a part of the delivery device not rotating during dose expelling and comprising a printed circuit board having a first surface on which is disposed a plurality of individual electrical conductive sensor areas arranged in a pattern, some of which being electrically connected to the (−) terminal of the power source unit, when the power source unit is retained in said retaining structure and some of which being connected to the processor unit, a second sensor part arranged opposite to the first sensor part and adapted to be directly or indirectly attached to said distal tip part of the piston rod to thereby follow the rotation of the piston rod during dose expelling, the second sensor part comprising a plurality of electrically connected contact structures, and wherein the contact structures are adapted to be connected to the (−) terminal of the power source unit via those electrically conductive sensor areas that are connected to (−) terminal of the power source unit, when the power source unit is retained in said retaining structure, the contact structures being adapted to, upon relative rotational movement between the first and second sensor part, electrically connect different individual electrically conductive sensor areas to the processor unit to thereby close an electrical circuit between the (−) terminal and the processor unit for the different conductive sensor area, each electrical connection generating an electrical signal to the processor unit being indicative of the rotational position between the first and second sensor part, and wherein the processor unit is adapted to process said signals to determine the amount of relative rotations between the first and second sensor part and thereby calculate the expelled dosage size based on the determined amount of relative rotations, and where the second housing part is adapted to engage said drug-filled cartridge and/or displaceable piston, when the delivery device is assembled, such that no rotation between the second housing part and drug-filled cartridge and/or piston is possible.

9. An assembly according to claim 7, wherein the distal tip part of the piston comprises a central bore and a circumferential portion having one or more deflectable gripping arms, and wherein the second sensor part comprises a cylindrical part extending through an opening in the first housing part and having one or more protrusions located on an outer surface, and where said cylindrical part is adapted to be moved into said bore, so that the deflectable gripping arms deflect over said protrusions and subsequently grip around said protrusions to provide a locked connection between the second sensor part and piston rod not allowing any relative rotation between the sensor part and piston rod.

10. An assembly according to claim 7 and assembled together with a drug delivery device by a method according to a method comprising the steps of: assembling the preassembled engine part and the first housing part by attaching the second sensor part to the distal tip part of the piston rod, positioning the power source unit in said power source unit retaining structure, attaching the second housing part to the first housing part via said attachment structure, and attaching said preassembled drug holding part to the preassembled engine part, such that the second housing part engages the drug-filled cartridge and/or piston.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0101] In the following the invention will be further described with reference to the drawings, wherein

[0102] FIG. 1 shows a disposable pen drug delivery device with a drug cartridge,

[0103] FIG. 2 shows a cross sectional view of the pen shown in FIG. 1 with an embodiment of a sensor module according to the invention,

[0104] FIGS. 3a-c show views of the module as arranged in the pen in FIG. 2,

[0105] FIG. 4 shows another embodiment of the module according to the invention,

[0106] FIG. 5 shows a third embodiment of the module according to the invention,

[0107] FIGS. 6a-c show fourth embodiment of module according to the invention,

[0108] FIG. 7 shows a cross sectional view of the module as shown in FIGS. 6a-c arranged inside a pen drug delivery device,

[0109] FIG. 8 shows the second sensor part of the module shown in FIG. 7 arranged inside a pen drug delivery device,

[0110] FIGS. 9a-h show the connection sequence of the module shown in FIGS. 6a-c and 7,

[0111] FIGS. 10a-h show an example of a connection sequence of a module according to the invention,

[0112] FIG. 11 shows an exploded view of a further rotary sensor module according to the invention,

[0113] FIGS. 12a-b show cross sectional views of exemplary embodiments of a rotary sensor module according to the invention,

[0114] FIGS. 13a-b show examples of the electrical circuit for the rotary sensor module according to the invention,

[0115] FIG. 14a-d show different embodiments of the centering element with different cross-sections,

[0116] FIG. 15 shows an exploded view of another embodiment of a rotary sensor module according to the invention,

[0117] FIG. 16 shows a cross-sectional view of the sensor module shown in FIG. 15, and

[0118] FIGS. 17-22 show embodiments of a sensing module having two separate housing parts.

DETAILED DESCRIPTION OF THE DRAWINGS

[0119] Referring to FIG. 1 a disposable pen drug delivery device 100 is shown with which the module according to the invention may be used. The device may represent a generic drug delivery device, however the one shown in FIG. 1 is a FlexTouch® prefilled pen drug delivery device sold by Novo Nordisk A/S. This pen is a spring driven pen and is described in detail e.g. in patent application WO 2014/161952, the disclosure of which is hereby incorporated by reference.

[0120] More specifically, the pen device comprises a main part having a proximal body or drive assembly portion with a housing 110 in which a drug expelling mechanism is arranged or integrated, and a distal cartridge holder portion 120 holding a drug-filled transparent cartridge 130 having a displaceable piston (not shown) and distal needle-penetrable septum 140. The cartridge holder has openings 150 allowing a portion of the cartridge to be inspected. The cartridge may for example contain an insulin, GLP-1 or growth hormone formulation. A proximal-most rotatable dose ring member 160 serves to manually set a desired dose of drug shown in display window 170 and which can then be expelled when the release button 180 is actuated.

[0121] Depending on the type of expelling mechanism embodied in the drug delivery device, the expelling mechanism may comprise a spring, as in the pen shown in FIG. 1, which is strained during dose setting and then released to drive a piston rod towards the distal end of the pen to advance a piston in the cartridge and thereby expel a dose when the release button is actuated. Alternatively the expelling mechanism may be fully manual.

[0122] FIG. 2 shows a cross sectional view of the pen shown in FIG. 1 (though the pen here also includes a cap part 190) and wherein a module according to the invention is arranged. The module (shown in detail in FIGS. 3a-c) is arranged between the piston rod 201 and the piston 202 of the cartridge 203, and where the first sensor part 210 of a sensor unit of the module is rotationally locked to the piston 202 in the cartridge via the housing 204.

[0123] The second sensor part 220 (the “wiper”) is rotationally locked to a tip part of the piston rod 201. As the first 210 and second sensor part 220 can rotate relative to the each other and as the piston 202 doesn't rotate during dose expelling, a rotational movement of the piston rod 201 during dose expelling will cause the second sensor part 220 to rotate relative to the first sensor part 210.

[0124] In FIGS. 3a-c is shown the module also shown in FIG. 2 with a flexible printed circuit board sheet 200 folded around the battery 206 in the form of a cell coin battery, i.e. the battery is meant to be positioned in between the two layers of the folded sheet 200, as shown in FIG. 3c. The sheet 200 may be adhered to both sides of the battery 206. One advantage of this build of the module is that the battery is used as the main load bearing part of the module, when the piston rod exert a force on the module to axially advance the piston in the cartridge to expel a dose of drug.

[0125] The second sensor part 220 has individual contact structures 308 in the form of three flexible arms adapted to deflect the different conductive sensor areas 305 of the first sensor part 210 into contact with a surface 306 of the battery (e.g. the (−) terminal) and thereby close the electrical circuit between the (−) terminal and processor unit 207 to provide an electrical signal, when the first 210 and second sensor part 220 rotate relative to each other.

[0126] The first sensor part 210, when placed in the pen, will via the housing part 204 be in a non-rotational engagement with the piston 202 of the cartridge 203.

[0127] Conductor(s) on the flexible PCB sheet may provide connection allowing the battery 206 to deliver a continuous low “sleep current” to the processor unit 207 in order for the processor unit to keep track of time however it may first be activated when the module is used for the first time.

[0128] The flexible printed circuit board sheet may also comprise means for wireless communication (see e.g. FIG. 6b) of data to an external device, e.g. an antenna may be disposed on the sheet.

[0129] FIG. 3c shows a side-view of the assembled module. When the first sensor part 210 and second sensor part 220 rotate relative to each other during dose expelling, when the module is arranged in the pen, the individual structures 308 of the second sensor part will deflect the conductive sensor areas 305 of the first sensor part into connection with the surface 306 of the battery, the surface being either the (−) or (+) terminal of the cell coin battery. In the figure, the sensor area 305 shown has not been deflected into connection yet, as there is a small space between the sensor area 305 and the surface 306, however it will be deflected into connection when a structure 308 overlaps the sensor area 305 upon relative rotation between the first and second sensor part.

[0130] The sensor areas 305 and the structures 308 are configured to create a pattern of contact positions indicative of a rotational position between the first and second sensor part, and the processor unit 207 can then process the electrical signals received indicative of the relative rotational position between the first and second sensor part to determine the amount of relative rotation and based thereon calculate a corresponding expelled dose and store this data.

[0131] In another embodiment shown in FIG. 4, electrically connected contact structures 408 of the second sensor part 407 are adapted to connect conductively directly to the plurality of individual electrically conductive sensor areas 405 of the first sensor part 401 upon relative rotation between the first and second sensor part. An advantage of this embodiment is that the torque applied on the structures of second sensor part is low as the structures don't have to deflect the sensor areas 405.

[0132] The battery 410 is intended to be positioned in the space 413 in the folded flexible printed circuit board sheet 400. A housing 415 is provided to house the flexible printed circuit board sheet 400, the battery 410 and the processor unit 411, the housing being arranged such that the surface 416 is positioned in the space 414 and thus supports the first surface of the first sensor part 401 underneath. The small conductive sensor areas of the first sensor part will be connected to the processor unit and the large sensor areas will be connected to (−) terminal of the power battery 410. In this embodiment the second sensor part may be connected to the (−) terminal but not necessarily.

[0133] The second sensor part 407 is adapted to engage the piston rod 409 such that no rotation between the second sensor part and piston rod is not possible, and the housing 415, including the flexible printed circuit board sheet 400, battery 410 and processor unit 411, is adapted to engage the piston of the drug cartridge (not shown), such that no rotation between the housing and thus first sensor part 401 is possible.

[0134] When the first 410 and second sensor part 407 rotate relative to each other the contact structures 408 electrically connect the different conductive sensor areas 405 of the first sensor part and thereby close the electrical circuit between the (−) terminal and processor unit 411 to provide an electrical signal to the processor unit being indicative of the rotational position between the first and second sensor part, and the processor unit is adapted to process the signals to determine the amount of relative rotations and thereby calculate the amount of expelled dosage size.

[0135] FIG. 5 shows another embodiment of the module according to the invention. As can be seen in the detailed cross-sectional view of the flexible printed circuit board sheet 200, the first sensor part 210 of the dosage sensor unit has a first surface 501 on which the individually electrically conductive sensor areas 505 are disposed on. A second surface area 506 is arranged axially offset to the areas 505 and perpendicularly relative to the axis of rotation of the second sensor part 220, and where electric conductive material forms the second surface area 506. As the structures 508 upon rotation of the second sensor part 220 overlaps the individually electrically conductive sensor areas 505, the structures will deflect the sensor areas 505 into conductive electrical connection with the second surface area 506 to close the electrical circuit and provide the signals to the processor unit.

[0136] In FIGS. 6a-c is shown another embodiment of a module. FIG. 6a shows a flexible printed circuit board sheet 600 comprising individual conductive sensor areas 605 separated by areas 625, electrical conductors 606 and processor unit 611. Each of the sensor areas 605 is connected to the processor unit 611, whereas the areas 625 are not connected to a conductor and are thus not part of the electrical circuit. A communication unit 617 is disposed on the flexible printed circuit board sheet and adapted to wirelessly communicate data to an external device.

[0137] Spacers 618, 619 are arranged to provide axial spacing between the conductive sensor areas 605 and a second surface area, in this embodiment a surface 609 of the battery 610, see FIG. 6c. The spacers 618, 619 provide axial spacing to avoid unwanted connections to occur while still enabling the individual sensor areas 605 to be brought into galvanic conductive contact with the surface area 609 of the battery 610 when acted upon by the second sensor part 607. The second sensor part 607 has three flexible arms (“wipers”) each with a structure 608 adapted to deflect different sensor areas 605 into contact with the surface 609 of the battery (the (−) terminal) when the structure 608 overlaps a sensor area 605.

[0138] When the sensor unit is an inactive state, only the support surfaces 622 of the arms will engage the flexible printed circuit board sheet on the side opposite to side facing surface areas 609 of the battery, as shown in the leftmost drawing of FIG. 6c. When an axial force is applied to the second sensor part in a direction towards the first sensor part, or vice versa, i.e. the module is being compressed, the arms will deflect outwards and thereby forcing the structures 608 into engagement with the areas 605 and 625, respectively.

[0139] The second sensor part 607 has attachment means 624 allowing the second sensor part to be attached, either directly or indirectly, to the piston rod such that no relative rotation between the second sensor part and the piston rod is possible.

[0140] (+) and (−) terminals 620, 621 are provided on the flexible printed circuit board sheet for connection to the terminals of the battery 610.

[0141] FIG. 7 shows a cross sectional view of a module as shown in FIGS. 6a-c arranged inside a pen drug delivery device 700. Compared to the embodiment shown in FIGS. 2 and 3a-c, the module in FIG. 7 is positioned in a proximal end of the pen opposite to the end in which the drug-filled cartridge 710. The pen has a dose ring member 730 serving to manually set a desired dose of drug. The pen has a spring 740 which is strained during dose setting and then released to drive the piston rod 750 rotationally and axially towards the distal end of the pen to advance the piston 720 and thereby expel a dose, when the release button 760 is actuated in an axial direction 770.

[0142] The module is positioned such that the second sensor part 607 of the sensor unit is engaged and rotationally locked to a drive tube 705 via the element 706, the drive tube being in engagement with the piston rod 750 to rotationally drive the piston rod during dose expelling, meaning that the second sensor part 607 is indirectly fixed to the piston rod and will follow the rotation thereof during dose expelling. The first sensor part 601 of the sensor unit is arranged axially offset to the second sensor part 607 and perpendicularly relative to the axis of rotation and is fixed in the pen such that it doesn't rotate during dose expelling.

[0143] The flexible printed circuit board sheet 600 is folded around the battery 610. The pen with the module as shown in FIG. 7 functions as follows; the desired dose of drug to be expelled is set by rotating the dose ring member 730 until the desired dose is shown in a window on the pen. During dose setting the spring 740 is strained to build up a driving force needed to drive the piston rod 750 forward during dose expelling. During the dose setting there is no electrical connection to the conductive sensor areas and the sensor unit is inactive (“dose setting mode”).

[0144] To expel the set dose, the injection button 760 is pushed axially in the direction 770, whereby the first sensor part 601 together with battery etc. is moved axially towards the second sensor part 607. When the injection button is moved the distance 761, the spring hasn't been released yet, but the structure 608 have deflected a respective conductive sensor area 605 into connection with the surface 606 to connect it to the electrical circuit and the sensor unit is then activated (“dose expelling mode”) and the processor unit will get signals indicative of the start position of the sensor unit. When the injection button is pushed further axially, both the injection button 760 and the part 763 will move together the distance 762 and the spring 740 will be released. Now the drive tube 706 and accordingly the piston rod 750 will start rotating and advance axially toward the piston 720 to expel the dose. As the second sensor part 607 is rotationally locked to the piston rod via the drive tube, it will start rotating together with piston rod and the structures 608 will then in turn deflect respective conductive sensor areas 605 into connection with the surface 609 of the battery. The established connections generate an electrical signal, as explained above, to the processor unit, said signal being indicative of the relative rotational position between the first and second sensor part.

[0145] FIG. 8 shows the second sensor part 607 of the module arranged inside the pen drug delivery device 700. The second sensor part 607 with the structure 608 and support surfaces 622 is fixedly attached to the piston rod via the drive tube 705, so that it follows the rotation of the drive tube 705 and thereby the piston rod during dose expelling.

[0146] FIGS. 9a-h show the connection sequences of the sensor unit of FIG. 6c, when the first and second sensor parts rotate relative to each other during dose expelling.

[0147] In FIG. 9a the sensor unit is in its initial start position, where no drug has been expelled yet but the one structure 608 of second sensor part has closed the electrical circuit between the (−) terminal and the processor unit for conductive sensor area 605 by deflecting it into conductive electrical connection with the conductive surface area 609 ((−) terminal) of the battery. The sensor unit is now turned “on” and ready to sense relative rotations. None of the other conductive sensor areas of the first sensor part are in conductive connection with the surface of the battery at this stage.

[0148] In FIG. 9b the second sensor part has been rotated 15 degrees clockwise compared to the positon in FIG. 9a, so that another structure 608 has provided conductive connection between another conductive sensor area 605 and the surface area 609. In FIG. 9c the second sensor part has been rotated 15 degrees clockwise compared to the position in FIG. 9b and so forth.

[0149] FIGS. 10a-h show an example of connection sequences of a module according to the invention. The first sensor part has four conductive sensor areas 1001 (shaded) in the form of arc-segments evenly distributed around a circle, i.e. 90 degrees between, each connected to a processor unit. The four other conductive sensor areas 1002 (non shaded) are connected to the (−) terminal of a power source unit. The second sensor part has three arms 1003 positioned with 120 degrees between each. In FIG. 10a the sensor unit is in its initial start position, where no drug has been expelled. In FIG. 10b the second sensor part has been rotated 15 degrees counter clockwise compared to the positon in FIG. 10a, so that another structure of second sensor part has closed the electrical circuit between (−) terminal and the processor unit (not shown) for a further conductive sensor area. In FIG. 10c the second sensor part has been rotated 15 degrees counter clockwise compared to the position in FIG. 10b and so forth.

[0150] The code pattern for the embodiments of the module shown in the figures is based on a “resolution” of 15 degrees of rotations between each connection, which for a given drug formulation and delivery device combination may correspond to 1 unit (IU) of insulin, i.e. one full 360 degrees revolution of the piston rod corresponds to 24 units (IU). As can be seen in the FIGS. 9a-h and 10a-h, the sensor configuration with three arms (wipers) and four or eight conductive sensor areas creates a pattern that repeats after eight rotations of 15 degrees, equal to eight units of insulin. In a spring driven pen device, where the spring force typically will force the piston rod to rotate very fast during injection of the first 2-6 units, the sensor unit may jump some connections. However, by using the sensor configurations shown there are only eight units of absolute placement of the sensor, why the determination of the relative position between the first and second sensor part of the sensor still is reliable, even if the sensor may jump some connections.

[0151] Further, the use of only three arms has the advantage that the friction force between the first and second sensor part is kept low (the fewer arms the lower friction) and that the torque is the same on all three arms, as long as the arms are made of flexible material.

[0152] For a drug formulation having the double concentration a 7.5 degree rotary “resolution” would be necessary to register dose steps corresponding to 1 IU of insulin, unless each dose step equals 2 IU and instead of 1 IU.

[0153] As a given dose of drug, especially if large, may be divided and injected with a given pause, the module may be programmed to log two dose amounts expelled within a given time window, e.g. 15 minutes, as one dose.

[0154] An exploded view of a rotary sensor module according to the invention is shown in FIG. 11. A rotary sensor module comprises a first sensor part 1110 in the form of a flexible printed circuit board sheet having a surface 1122 with twentyfour individual electrically conductive sensor areas 1105 distributed circumferentially around a centre axis B, 1121, of the first sensor part and some of which are connected to (−) terminal and some of which being connected to processor unit. The first sensor part is adapted to engage directly or indirectly the piston 202 of the drug-filled cartridge and thereby provides an engagement between the first sensor part 1105 and the piston 202, such that no relative rotation there between is possible.

[0155] The rotary sensor module further comprises a second sensor part 1120 oppositely arranged to said surface 1122 of the first sensor part 1110 and mounted to the piston rod 201 at its distal tip part 1125 to follow the rotation of the piston rod during dose expelling. The piston rod has a centre axis A, 1128, around which is rotates during dose expelling.

[0156] The second sensor part has contact structures 1108 in the form of two electrically connected flexible arms that are connected to the (−) terminal of the battery and adapted to engage and electrically connect different individual electrically conductive sensor areas 1105 of the first sensor part, upon relative rotational movement between the first and second sensor part, to the processor unit to thereby close an electrical circuit between the (−) and the processor unit. Each of these electrical connections generates an electrical signal to a processor unit being indicative of the rotational position between the first and second sensor part. See more detailed description of this in connection with FIGS. 13a-b.

[0157] A centering element 1126 is provided between the first and second sensor part for centering the piston rod and thereby the second sensor part 1120 in relation to the first sensor part 1110, which is essential for the rotary sensor to measure the correct amount of relative rotations between the piston rod and piston. The centering element 1126 comprises a bearing cup part 1127 with a centre axis C, 1129, for maintaining the distal part of piston rod, in this situation a part of the second sensor part 1120, in a position where the axis' 1121, 1128 are coinciding.

[0158] To provide a proper centering, the bearing cup part 1127 can have different forms as depicted in FIGS. 14a-d.

[0159] In FIG. 12a is shown a cross sectional view of an exemplary embodiment of a rotary sensor module, where the second sensor part 1220 is attached to the distal part 1225 of the piston rod to follow the rotation of the piston rod. The centering element 1226 is attached to the first sensor part 1210, such that the center axis of the bearing cup part is coinciding with the center axis of the first sensor part. The distal tip part is centered via the bearing cup part, whereby a complete alignment between the first sensor part and the piston rod and thereby second sensor part is achieved. The alignment ensures that the contact structures 1208 always maintain contact with the surface 1222 and thereby generate a proper signal for each and every single mutual relative rotary movement between the sensor parts. Without the centering element, the two sensor parts may wobble in relation to each other as the piston rod rotates, whereby the structures of the second sensor part may jump over some of the conductive sensor areas of the first sensor part and generate a fault or no signal.

[0160] During dose expelling the piston rod is rotated and advanced axially in the direction of the piston in order to advance the piston forward in the cartridge. Thus, the piston rod will exert an axial force on the piston via the rotary sensor module and due to the centering element the torque required to rotate the piston rod in relation to the piston is minimised, as the centering element ensures that the mechanical contact between the parts rotating relative to each other is kept at the axis of rotation. The torque required can be even more minimised depending on the design of the centering element, see FIGS. 14a-d.

[0161] The centering element may be fixedly attached to the first sensor part by different appropriate means, such as by riveting, soldering or gluing. If soldered, the centering element can function as an electrical contact between e.g. the (−) terminal and the second sensor part, as shown and described in FIG. 12b.

[0162] In FIG. 12b is shown cross sectional view of another exemplary embodiment of a rotary sensor module, where the second sensor part 1220 is attached to the distal part 1225 of the piston rod to follow the rotation of the piston rod. In this embodiment, the centering element 1226 and the bearing cup part 1227 is made of electrically conductive material and is electrically connected to the (−) terminal of the battery (not shown in the figure). The second sensor part is electrically connected to the bearing cup part as shown, which allows for an electrical ground signal to be passed via the centering element to the second sensor part.

[0163] In FIGS. 13a-b, the conductive sensor areas (ENC1, ENC2, ENC3, ENC4) of the first sensor part are connected to the power source 1330 (“VCC”, (+) terminal) via the processor unit and the conductive sensor areas (1305a, 1305b, 1305c, 1305d) are connected to the (−) terminal 1331 (ground). The contact structure 1308 of the second sensor part will, as the first and second sensor parts rotate relative to each other, connect the different conductive sensor areas (ENC1, ENC2, ENC3, ENC4) and close the electrical circuit between the (−) terminal and the processor unit. As a sensor area (ENC1, ENC2, ENC3, ENC4) is connected to ground the electrical circuit is closed and the specific sensor area is turned “on” and a signal will be generated to the processor unit. The readout for the specific sensor area that is turned on will be a “1” and the readout for a sensor area that is turned off will be “0”. In the example shown in FIG. 13a, the “ENC2” is connected, as the contact structure 1308 close the electrical circuit to (−) terminal and processor unit, why the readout in the processor unit for this specific relative position between the first and second sensor part will be “0”, “1”, “0”, “0” for the sensor areas ENC1, ENC2, ENC3 and ENC4, respectively. Based on the readouts the processor unit can determine the amount of relative rotations between the sensor parts and thereby between the piston rod and piston of the injection device. Knowing the amount of relative rotations between the piston rod and piston, the size of the dose expelled from the injection device can be determined and stored in the processor unit.

[0164] In order to save power, the processor unit may, immediately after registering the readout of a sensor area (ENC1, ENC2, ENC3, ENC4), switch the electrical circuit “off” for that specific sensor area. This is shown in the diagram in FIG. 13a, where the electrical switch mechanism 1340 is “open” for ENC2. The electrical switch mechanism may be in the form of a pull-up resistor to open the electrical circuit to a sensor area after the electrical circuit has been closed and an electrical signal has been received by the processor unit for the sensor area, the pull-up resistor being controlled by the processor unit. This will effectively save power as the sensor areas don't need to be powered up all the time to monitor sensor transitions. However, a detection of the next transition for this specific sensor area will not be detected as the electrical circuit is open by the pull-up resistor. A way of reducing this problem is to implement an intelligent control of the pull-up resistors. Initially, only pull-up resistors for all open electrical circuits are activated. When a sensor transition is detected all pull-up resistors are activated, allowing software in the processor unit to detect all sensor transitions and a timer is started. Every time a sensor transition is detected, the timer is reset to its original value, and when the timer times out, the system reverts to only having the pull-up resistors for open electrical circuits activated. The sensor will consume power during and shortly after a detected transition but will zero-power when static.

[0165] FIG. 13b shows the electronic circuit of the embodiment of the sensor module shown in FIG. 3b. In this more simple embodiment, the ground (−) terminal 1331 is connected to the second sensor part only, i.e. none of the conductive sensor areas of the first sensor part is connected to ground. The ground (−) connection to the second sensor part may e.g. be via the centering element, as shown and described under FIG. 13b above.

[0166] FIG. 14a-d shows various cross-sectional views of the bearing cup part of the centering element according to the invention. The choice of cross-sectional view is a compromise between level of mechanical play between the centered parts in the bearing cup part and the friction force and thereby torque added by the centering element to rotate the piston rod relative to the piston. It is preferred to have best possible centering while adding minimum of friction and torque, the latter to obtain as low injection force needed to expel a dose of drug.

[0167] FIG. 14a shows a V-shaped cross-section 1427a, which ensures proper centering with little to no mechanical play in the bearing.

[0168] FIG. 14b shows a U-shaped cross-section 1427b, which ensures proper centering with very little mechanical play and only a single point of contact reducing friction between the piston rod and centering element.

[0169] FIG. 14c shows a trapezoid shape 1427c, which improves centering but do allow for some mechanical play.

[0170] FIG. 14d shows a square shape 1427d, which improves centering but do allow for some mechanical play.

[0171] FIG. 15 shows an exploded view of an alternative embodiment of a rotary sensor module according to the invention. A first cylindrical formed rotary sensor part 1520 to be connected to the piston rod comprises a plurality of individual electrically conductive sensor areas 1505 (in this example nine sensor areas) arranged in a pattern spaced apart around a cylindrical surface on the part 1529 and extending parallel to the axis of rotation of the piston rod. The rotary sensor part 1520 consists of two components, a metal part 1529 with the conductive sensor areas 1505 and non-conductive plastic part 1530. In an assembled version, the metal part 1529 may be over moulded with the non-conductive plastic part.

[0172] The module further comprises a second stationary sensor part 1510 comprising a flexible printed circuit board sheet 1500 on which are located contact structures 1508 extending parallel to the axis of rotation of the piston rod. The flexible sheet 1500 is folded around a cell coin battery 1506 (see FIG. 16) and the contact structures are connected to the (+) terminal 1528 via the processor unit 1507. The second sensor part is adapted to be fixed to the piston in the cartridge 203 in a manner that allow no rotation between the piston and the sensor part.

[0173] A centering element 1526 is located between the two sensor parts and is made of conductive material. When assembled (see FIG. 16) the centering element engages the (−) terminal 1531 of the battery either directly or through the flexible sheet 1500 having conductive material located between the centering element and the (−) terminal 1531. Thereby, the sensor areas 1505 are connected to the (−) terminal 1531. The centering element further centers the piston rod 201 and thereby the sensor part 1520 in relation to the sensor part 1510 to ensure a proper alignment between the sensor parts and thereby an accurate readout from the sensor module.

[0174] The module preferably also comprise a communication unit to wirelessly communicate data (dose size, timestamp) from the module to an external device.

[0175] FIG. 16 shows a cross-sectional view of the sensor module of FIG. 15 positioned in the pen drug delivery device, where the first rotary sensor part is co-axially and partly located inside the second stationary sensor part.

[0176] As the piston rod rotates during dose expelling, the contact structures 1508 (four in total) will electrically connect to different individual electrically conductive sensor areas 1505. In FIG. 16 it can be seen that contact structure (or switch) 1508a (a round metallic ball) is electrically in contact with a sensor area 1505a, whereby electricity is conducted from (−) terminal 1531 via the conductive centering element 1526 all the way to the contact structure 1508a and to the processor unit 1507, i.e. the electrical circuit is closed and the processor receives an electrical signal indicating e.g. an “on” or “1” for this specific sensor area 1505a. Whereas to the right side, the contact structure 1508b is in contact with a non-conductive area, i.e. it is open and the processor unit will recognise it as “off” or “0”. Each time a contact structure connects to a sensor area an electrical circuit will be closed and the processor unit receive an electrical signal, each electrical being indicative of the rotational position between the first and second sensor part. It means that during an injection of drug, electrical circuits will be closed or open depending on the mutual position between the first and second sensor part and generate electrical signals to the processor unit. Each of these positions will be translated into the amount of relative rotations between the first and second sensor part and thereby no. of rotations of the piston rod. Based on the no. of rotations of the piston rod, the expelled dose of drug can be determined by the processor unit. This information together with a timestamp for when the injection was taken can be transferred wirelessly to a receiving unit. e.g. a mobile phone.

[0177] FIGS. 17-22 show embodiments of a sensing module having two separate housing parts to allow for a flexible assembly of the module and drug delivery device, where the battery (power source unit) can be inserted late in the assembly process to thereby save the battery and extend its lifetime. The dose detection principle for these embodiments is similar to that described above.

[0178] FIGS. 17 and 18 show a side view of a piston rod 201 of a dose expelling mechanism of a drug delivery device attached to a sensing module having a first housing part 1701 and a second housing part 1702 being attachable to each other via attachment means 1704 to form a single common sensing module house. In FIG. 18, the two housing parts 1701 and 1702 are not assembled yet, whereby the battery 1703 can be slit into the power source unit retaining means 1705.

[0179] FIG. 19 shows the sensing module from a different view. The second housing part 1702 has surfaces 1706 adapted to engage a displaceable piston 202 in the drug-filled cartridge of the drug delivery, when the module is inserted in the drug delivery device, such that no rotation between the second housing part and the piston is possible. The surfaces 1706 has a surface roughness being sufficient to avoid any relative rotation between the housing part and the piston. Alternatively, as the piston normally is made of an elastomer, the engagement may be provided by establishing a vacuum between the surface of the housing part and the surface of the piston, which is sufficient to avoid relative rotation.

[0180] FIG. 20 shows an exploded view of the sensing module including the first housing part 1701, a second sensor part 1707, the power source unit (battery) retaining means 1705, supporting structure 1715 for the first sensor part, the battery 1703 and the second housing part 1702.

[0181] A first sensor part 1714 is fixed in the first housing part via the supporting structure 1715 such that no relative rotation between the first sensor part and the housing is possible. The first sensor part has a flexible printed circuit board sheet having a first surface supported by the structure 1715 on which is disposed a plurality of individual electrically conductive sensor areas arranged in a pattern (not shown in FIGS. 17-22). Alternatively to being a support for a flexible printed circuit board sheet the supporting structure 1715 may be a rigid printed circuit board having disposed on a first surface thereof a plurality of individual electrically conductive sensor areas, arranged in a pattern.

[0182] FIG. 21 shows a cross sectional view of the sensing module attached to the distal tip part of the piston rod 201. The distal tip part of the piston rod 201 comprises a central bore 1708 and a circumferential portion having deflectable gripping arms 1709. The second sensor part comprises a cylindrical part 1710 extending through an opening 1711 in the first housing part 1701 and having protrusions 1712 located on its outer surface. When assembling, the cylindrical part 1710 is moved into the bore 1708, whereby the deflectable gripping arms 1709 deflect over said protrusions and grip around said protrusions and provide a locked interconnection between the second sensor part and the piston rod not allowing any relative rotation between the sensor part and the piston rod. The surface 1706 of second housing part 1702 is preferably made of an elastomer that provides sufficient friction against the elastomeric surface of the piston in the cartridge in order to avoid relative rotation therebetween.

[0183] FIG. 22 shows a cross-sectional view of another embodiment of the sensing module, where the second housing part 1702 has engaging means 1713 in the form of a elastomeric flange engaging the internal sidewall of the drug-filled cartridge 203. This flange provide sufficient friction to avoid any relative rotation between the second housing part and the cartridge. Further, by this flange a vacuum can be provided between the second housing part and the piston, which avoids that the piston can advance axially by itself. The latter is often seen in situations, where a user leaves an injection needle on, whereby the piston can move axially forward by gravity only, as the drug can drain from the cartridge through the needle.

[0184] Designing the sensing module as shown in FIGS. 17-22 with two separate attachable housing parts for quick installation of the battery and final assembly gives a flexible assembly process that can be designed without wasting battery power.

[0185] For any of the described embodiments above the conductive sensor areas and the contact structures together are configured to create a code pattern of contact positions (encoder) indicative of the rotational positions between the first and second sensor part. The indexing code pattern may be based on a Gray code system or quadrature code system or any other relevant system. The Gray code could e.g. be a 4 bit 72 increment encoder system, where the pattern repeats 9 times for each 360 degrees revolution.

[0186] In the above description of exemplary embodiments, the different structures and means providing the described functionality for the different components have been described to a degree to which the concept of the present invention will be apparent to the skilled reader. The detailed construction and specification for the different components are considered the object of a normal design procedure performed by the skilled person along the lines set out in the present specification.