DRUG DELIVERY DEVICE AND METHOD FOR DETERMINING A DOSE

Abstract

The present disclosure refers to a drug delivery device including, a dose setting and/or drive mechanism including a stationary housing having at least one internal groove on an inner surface; a driver positioned within the housing which is moveable relative to the housing during dose dialing and which is moveable relative to the housing during dose dispensing; and at least one flexible tab that is biased to engage the at least one internal groove such that the at least one flexible tab repeatedly engages and disengages the at least one internal groove during dose dialing or during dose dispensing, thereby performing an oscillating movement between two positions including a first position in which the at least one flexible tab engages the at least one internal groove and a second position in which the at least one flexible tab is disengaged from the at least one internal groove.

Claims

1-15. (canceled)

16. A drug delivery device comprising, a dose setting and/or drive mechanism comprising a stationary housing having at least one internal groove on an inner surface; a driver positioned within the housing which is moveable relative to the housing during dose dialing and which is moveable relative to the housing during dose dispensing; at least one flexible tab that is biased to engage the at least one internal groove such that the at least one flexible tab repeatedly engages and disengages the at least one internal groove during dose dialing or during dose dispensing, thereby performing an oscillating movement between two positions comprising a first position in which the at least one flexible tab engages the at least one internal groove and a second position in which the at least one flexible tab is disengaged from the at least one internal groove; and at least one micro-electro-mechanical system comprising at least one sensor configured and arranged to detect the oscillating movement of the at least one flexible tab during dose dialing or during dose dispensing.

17. The drug delivery device according to claim 16, wherein the driver is rotatable relative to the housing during dose dialing and is axially displaceable relative to the housing during dose dispensing.

18. The drug delivery device according to claim 16, wherein the at least one sensor is an acceleration sensor located in or on the at least one flexible tab.

19. The drug delivery device according to claim 16, further comprising a light source, wherein the at least one sensor is an optical sensor located in or on the at least one flexible tab and aligned with the light source such that light emitted by the light source can be detected by the sensor only in one of the first or second position, whereas the light emitted by the light source cannot be detected by the sensor in the other of the two positions.

20. The drug delivery device according to claim 16, further comprising a light source located in or on the at least one flexible tab, wherein the at least one sensor is an optical sensor aligned with the light source such that light emitted by the light source can be detected by the sensor only in one of the first or second position, whereas the light emitted by the light source cannot be detected by the sensor in the other of the two positions.

21. The drug delivery device according to claim 16, further comprising a light source, wherein the at least one flexible tab is made of a light transmitting material and the light source is located to introduce light into the at least one flexible tab, wherein the at least one sensor is an optical sensor located aligned with the at least one flexible tab such that light emitted by the at least one flexible tab can be detected by the sensor only in one of the first or second position, whereas the light emitted by the at least one flexible tab cannot be detected by the sensor in the other of the two positions.

22. The drug delivery device according to claim 16, wherein the at least one micro-electro-mechanical system further comprises a microprocessor which is operatively connected to the at least one sensor, to a power source, and to a memory, wherein the microprocessor is configured to determine a dose amount selected by rotation of the driver during dose dialing or during dose dispensing.

23. The drug delivery device according to claim 22, further comprising a communication unit connected to the at least one micro-electro-mechanical system and configured to transmit data corresponding to the dose amount determined by the microprocessor to a remote data management unit.

24. The drug delivery device according to claim 16, further comprising a blocking member slidably positioned inside the driver that locks the at least one flexible tab into the at least one internal groove during dose dispensing such that the driver follows the path of the at least one internal groove.

25. The drug delivery device according to claim 24, wherein the at least one flexible tab is an integral part of the driver.

26. The drug delivery device according to claim 25, wherein the blocking member has an aperture or pocket that is aligned with the flexible tab when the blocking member is in a non-locked position and is misaligned with the flexible tab when in the locked position.

27. The drug delivery device according to claim 26, wherein the aperture or pocket is aligned with the flexible tab during dose dialing and is misaligned with the flexible tab during dose delivery.

28. The drug delivery device according to claim 24, wherein the blocking member is provided with the at least one flexible tab.

29. The drug delivery device according to claim 28, wherein the driver has an aperture or pocket that is aligned with the flexible tab when the blocking member is in a non-locked position and is misaligned with the flexible tab when in the locked position.

30. The drug delivery device according to claim 29, wherein the aperture or pocket is aligned with the flexible tab during dose dialing and is misaligned with the flexible tab during dose delivery.

31. The drug delivery device according to claim 16, further comprising a cartridge containing a medicament.

32. A method for determining a dialed or dispensed dose in a drug delivery device, the drug delivery device comprising a stationary housing having at least one internal groove on an inner surface; a driver positioned within the housing which is moveable relative to the housing during dose dialing and which is moveable relative to the housing during dose dispensing; at least one flexible tab that is biased to engage the at least one internal groove such that the at least one flexible tab repeatedly engages and disengages the at least one internal groove during dose dialing or during dose dispensing, thereby performing an oscillating movement between two positions comprising a first position in which the at least one flexible tab engages the at least one internal groove and a second position in which the at least one flexible tab is disengaged from the at least one internal groove; and at least one micro-electro-mechanical system comprising at least one sensor configured and arranged to detect the oscillating movement of the at least one flexible tab during dose dialing, a microprocessor which is operatively connected to the at least one sensor, to a power source, and to a memory, wherein the microprocessor is configured to determine a dose amount selected by rotation of the driver during dose dialing or during dose dispensing; the method comprising: dialing or dispensing a dose by moving the driver; inducing the at least one sensor of the at least one micro-electro-mechanical system to detect the oscillating movement of the at least one flexible tab and processing a signal generated by the at least one sensor in response to the oscillating movement of the at least one flexible tab in the microprocessor to determine a dose amount selected by movement of the driver during dose dialing or during dose dispensing.

33. The method according to claim 32, wherein moving the drive comprises rotating the driver.

34. The method according to claim 32, further comprising transmitting data corresponding to the dose amount determined by the microprocessor to a remote data management unit.

35. The method according to claim 32, wherein the at least one sensor comprises an acceleration sensor.

36. The method according to claim 32, wherein the drug delivery device further comprises a light source and the at least one sensor comprises an optical sensor.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0048] Non-limiting, exemplary embodiments of the invention will now be described with reference to the accompanying drawings, in which:

[0049] FIG. 1 is a view of a resettable drug delivery device;

[0050] FIG. 2 is a cross sectional view of a portion of the device of FIG. 1 according to a first embodiment;

[0051] FIG. 3 is a cross sectional view of a portion of the device of FIG. 1 according to a second embodiment;

[0052] FIG. 4 is a close-up of the cross sectional view of a third embodiment showing a locking member in an un-locked position;

[0053] FIG. 5 is a close-up of the cross sectional view of the third embodiment showing the locking member in a locked position;

[0054] FIG. 6 is a cross sectional view of a fourth embodiment;

[0055] FIG. 7 is a perspective view of the driver of a fifth embodiment; and

[0056] FIG. 8 is a view of the driver of FIG. 7.

DETAILED DESCRIPTION

[0057] In the Figures, identical elements, identically acting elements or elements of the same kind may be provided with the same reference numerals.

[0058] The terms “axial”, “radial”, or “circumferential” as used herein may be used with respect to a main longitudinal axis 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.

[0059] “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 FIG. 1, 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 side in FIG. 1. 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.

[0060] In general, the drug delivery device may have substantially the configuration and functions as disclosed in WO 2010/139636 A1 or in EP 2 890 434 B1 to which reference is made regarding the description of the component parts and their functions.

[0061] Referring to FIG. 1, there is shown a drug delivery device 1 in accordance with an exemplary arrangement. The drug delivery device 1 includes a first cartridge retaining part 2, and a dose setting and/or drive mechanism 3 including. A number (or dose dialing) sleeve 4 of the dose setting and/or drive mechanism 3 is rotatable by actuation of a dose dial grip 5. The device further includes a dose display 6 which may include a lens or window permitting view on a portion of the number (or dose dialing) sleeve 4, which is partially received in an outer housing 7.

[0062] The drug delivery device may be a resettable drug delivery device (i.e., a reusable device) or alternatively a non-resettable drug delivery device (i.e., a non-reusable device). The cartridge retaining part 2 and the dose setting and/or drive mechanism 3 are secured together by connecting features. For non-resettable devices, these connecting features would be permanent and non-reversible. For resettable devices, these connecting features would be releasable. In this illustrated arrangement, the cartridge housing 2 is secured within the housing 5 of the dose setting and/or drive mechanism 3. A removable cap (not shown) may be releasably retained over a distal end of a cartridge retaining part 2 or cartridge housing. Preferably, the distal end of the cartridge retaining part 2 or cartridge housing includes a hub 8 for attaching a removable needle assembly (not shown).

[0063] The dose setting and/or drive mechanism 3 further includes an inner housing 9 which is secured to the outer housing 7 to be stationary. The inner housing 9 is provided with at least one groove 10 on its inner surface. In the embodiment depicted in FIG. 2, several grooves 10 are shown extending axially, i.e., in the direction from the distal end of the drug delivery device 1 to its proximal end. In the alternative embodiment depicted in FIG. 3 several grooves 10 are shown extending helically. Further, the inner housing 9 may be provided with an external thread as shown in FIGS. 2 and 3, e.g. for engaging the number (or dose dialing) sleeve 4.

[0064] FIGS. 4 and 5 depict a further embodiment wherein the inner housing 9 has axially extending grooves 10 as in FIG. 2. In this embodiment, a driver 11, a clutch sleeve 12 and a piston rod 13 of the dose setting and/or drive mechanism 3 are provided in a similar manner as disclosed in disclosed in WO 2010/139636 A1. In other words, the piston rod 13 is received in the driver 11, the driver 11 is a received in the clutch sleeve 12 and the clutch sleeve 12 is received in the inner housing 9.

[0065] As can be seen in FIGS. 4 and 5, the driver includes several flexible tabs 14 engaging with their free ends the respective grooves 10 of the inner housing 9. The clutch sleeve 12 is provided with apertures 15 permitting the flexible tabs 14 to pass through the clutch sleeve 12 for interaction with the grooves 10 of the inner housing 9. The flexible tabs 14 made disengage from the grooves 10 and may be flexed radially inwards against the spring force exerted by the flexible tabs 14.

[0066] Comparing FIGS. 4 and 5 it is evident that the clutch sleeve 12 and the driver 11 may be displaced relative to each other in the axial direction. The relative position depicted in FIG. 4 is a dose dialing position in which the driver 11 and the clutch sleeve 12 may be rotated together with the number (or dose dialing) sleeve 4 and the dose dial grip 5 relative to the outer housing 7 and the inner housing 9 to select a dose. Due to this rotation, the flexible tabs 14 are repeatedly forced out of engagement with the respective grooves 10 and the flexible back into engagement with the next groove 10. In other words, the flexible tabs 14 may override of the grooves 10 during dose dialing. This may generate an audible and/or tactile feedback. This oscillating movement of the flexible tabs 14 is indicative of dose dialing.

[0067] The relative position depicted in FIG. 5 is a dose dispensing position in which the driver 11 and to the clutch sleeve 12 are displaced relative to each other compared with the dose dialing position of FIG. 4. This made disengage a rotational clutch between the clutch sleeve 12 and the number (or dose dialing) sleeve 4. In the dose dispensing position, the driver 11 and the clutch sleeve 12 may be displaced axially, preferably without rotation, relative to the outer housing 7 and the inner housing 9. This axial displacement may be caused by a user pressing on dose dial grip 5 which causes the number (or dose dialing) sleeve 4 to rotate back into the outer housing 7 as disclosed in disclosed in WO 2010/139636 A1. Due to the axial displacement between the driver 11 and the clutch sleeve 12, the respective free ends of the flexible tabs 14 are displaced relative to the apertures 15, too, thereby preventing that the flexible tabs 14 are allowed to disengage from the respective grooves 10. Thus, the clutch sleeve 12 acts as a blocking member preventing disengagement of the flexible tabs 14 from the grooves 10 in the dose dispensing position of the drug delivery device.

[0068] In the embodiment depicted in FIGS. 4 and 5, the free end of one of the flexible tabs 14 is provided with an optical sensor 16, e.g. a MEMS sensor. Further, a light source 17, e.g., an LED, is provided in one of the apertures 15. The optical sensor 16 and the light source 17 are aligned to each other such that light emitted by the light source 17 may be detected if the respective flexible tab 14 is flexed radially inwards upon disengagement of the grooves 10. On the other hand, in the positions depicted in FIGS. 4 and 5, i.e., with the flexible tabs 14 engaging the respective grooves 10, the optical sensor 16 and to the light source 17 are located such that the light emitted by the light source 17 can not be detected by the optical sensor 16.

[0069] The oscillating movement of the flexible tabs 14 during dose dialing may be detected by the optical sensor 16 as the light emitted from the light source 17 is repeatedly detected and prevented from being detected by the optical sensor 16 as the driver 11 rotates relative to the inner housing 9. The signal generated by the optical sensor 16 may be processed and/or stored in a microprocessor (not shown) connected to the optical sensor 16. The amount of dose selected by rotation of the driver 11 may be determined by the microprocessor on the basis of the signal generated by the optical sensor 16 in response to the oscillating radial movement of the flexible tabs 14 during dose dialing.

[0070] In a not shown alternative, the MEMS optical sensor 16 may be provided in or on the clutch sleeve 12 while the light source 17 is provided in or on the flexible tab 14.

[0071] A further embodiment is depicted in FIG. 6 showing a sectional view of a drug delivery device including an inner housing 9 with a series of axially extending grooves 10 on its inner surface and a driver 11 with at least one flexible tab 14 engaging the grooves 10. Again, relative rotation between the driver 11 and the inner housing 9 occurs during dose dialing which results in an oscillating radial movement of the flexible tab 14 as it overrides the grooves 10.

[0072] In the embodiment of FIG. 6, a MEMS acceleration sensor 18 is located in the flexible tab 14 which again may be connected to a microprocessor. The acceleration sensor 18 detects the oscillating movement of the flexible tab 14 during dose dialing. Thus, the amount of dose selected by rotation of the driver 11 may be determined by the microprocessor on the basis of the signal generated by the acceleration sensor 18 in response to the oscillating radial movement of the flexible tabs 14 during dose dialing.

[0073] A similar embodiment is depicted in FIGS. 7 and 8 showing a driver 11 with a flexible tab 14 on which a MEMS acceleration sensor 18 is located which again may be connected to a microprocessor. The acceleration sensor 18 detects the oscillating movement of the flexible tab 14 during dose dialing.

[0074] In further embodiments (not shown), the flexible tab 14 may be made of a light transmitting material. Thus, a light source or an optical sensor may be located remote from the free end of the flexible tab 14. In a similar manner, the clutch sleeve 12 may be made of a light transmitting material, thereby allowing arrangement of a light source or an optical sensor or remote from the aperture 15. Still further, a light source or an optical sensor may be provided on or in the inner housing 9 instead of on or in the clutch sleeve 12.

[0075] In other words, according to one aspect of the disclosure, an acceleration MEMS sensor is located on a clicker arm. The clicker arm deflects (clicks) during dialing or dispensing of the device. The sensor measures the acceleration of the arm. The sensor could be either glued on, moulded in or clipped in. As an alternative, an optical sensor is located on the clicker arm or the clicker arm is made of a light transmitting material. The clicker arm deflects sequently during dialing or dispensing of the device. The sensor detects the light coming through or is reflected by the clicker arm in a defined position, at the time the clicker arm is deflect in a second position the sensor is not able to detect the light. Therefore the electronic is able to count units during dialing or dispensing.

REFERENCE NUMERALS

[0076] 1 drug delivery device [0077] 2 cartridge retaining part [0078] 3 dose setting and/or drive mechanism [0079] 4 number (or dose dialing) sleeve [0080] 5 dose dial grip [0081] 6 dose display [0082] 7 outer housing [0083] 8 hub [0084] 9 inner housing [0085] 10 groove [0086] 11 driver [0087] 12 clutch sleeve [0088] 13 piston rod [0089] 14 piston [0090] 15 aperture [0091] 16 optical sensor (MEMS) [0092] 17 light source [0093] 18 acceleration sensor (MEMS)