BUTTON AND BUTTON ASSEMBLY FOR A DRUG DELIVERY DEVICE
20200330697 ยท 2020-10-22
Inventors
- Ralph Donald Quentin Collings (Bristol, GB)
- James Robert Coop (Bristol, GB)
- James Anthony West (Bristol, GB)
- Stephen Francis Gilmore (Bristol, GB)
- Daniel David Higgins (Bristol, GB)
- Mark Digby Teucher (Bristol, GB)
- Matthew Meredith Jones (Warwick, GB)
- Anthony Paul Morris (Warwick, GB)
- Sophie Louise Sladen (Warwick, GB)
- William Geoffrey Arthur Marsh (Warwick, GB)
- Denny Lustosa Horn (Frankfurt am Main, DE)
- Stefan Blancke (Frankfurt am Main, DE)
- Michael Jugl (Frankfurt am Main, DE)
Cpc classification
A61M5/31585
HUMAN NECESSITIES
A61M5/24
HUMAN NECESSITIES
A61B2017/00367
HUMAN NECESSITIES
International classification
Abstract
A button (70, 270, 370, 470) for a drug delivery device with a reduced operating loudness comprises a plate-like button body forming a touch surface (70b, 270b, 370b, 470b), wherein the plate-like button body is coupled by an axial supporting member (75, 275, 375, 475) to a noise-generating interface of the drug delivery device and movable into a longitudinal direction of the drug delivery device, wherein the plate-like button body comprises a material composite with at least one first component (271, 272, 371, 372, 373, 374, 471) consisting of a first material and at least one second component (278, 378, 478) consisting of a second material different from the first material, wherein the at least one first component (271, 272, 371, 372, 373, 374, 47) and the at least one second component (278, 378, 478) are coupled via at least one coupling plane (270d, 270e, 370d, 470d) that is at least sectionwise slanted or perpendicular to the longitudinal direction. Further, the invention describes a button assembly for a drug delivery device which is shock resistant.
Claims
1. A button assembly for a drug delivery device comprising a) a plate-like button body (570, 670) forming a touch surface (570b, 670b) and an axially elongated member (575, 675) connected to the plate-like button body (570, 670) for energy transmission to a driven element (695) of the drug delivery device or b) a sleeve-like button body (770) forming a touch surface (770b) and an end section that facilitates energy transmission to the driven element of the drug delivery device, and, for both alternatives a) and b), a support element (580, 680, 780), wherein the plate-like button body (570, 670) or the sleeve-like button body (770) is movable into a longitudinal direction relative to the support element (580, 680) against the tension of a first resilient member (582, 682, 712) retained by the support element (580, 680, 780) and the plate-like button body (570, 670) or the sleeve-like button body (770), wherein the plate-like button body (570, 670) and/or the axially elongated member (575, 675) or the sleeve-like button body (770) comprises a shock deactivation mechanism preventing movement of the plate-like button body (570, 670) or the sleeve-like button body (770) relative to the support element (580, 680, 780) or preventing transmission of a shock force to the driven element (695) of the drug delivery device caused by the shock force acting at the plate-like button body (570, 670) or at the sleeve-like button body (770), wherein the shock force comprises at least one of a force component running transversal to the longitudinal direction of the button assembly and a force component running opposite to gravity.
2. The button assembly of claim 1, wherein the deactivation mechanism is realized by a plate-like button body (570) or a sleeve-like button body (770) comprising a material composite with at least one first material component (571) consisting of a first material and at least one second material component (578, 778, 770a) consisting of a second material different from the first material and a higher elasticity and/or plasticity than the first material, wherein the second material forms at least partially a side surface (574, 774) of the plate-like button body (570) or the sleeve-like button body (770) in a region opposite to a proximal end of the support element (580, 780).
3. The button assembly of claim 1, wherein the deactivation mechanism comprises an acceleration sensor.
4. The button assembly of claim 3, wherein the acceleration sensor comprises a seismic mass element (697) within a recess (676a) of the plate-like button body (670) or the axially elongated member (675), wherein a shock force with a force component running opposite to gravity causes a movement of the seismic mass element (697) against the tension of a second resilient member (698) away from its resting position (699) and parallel to the longitudinal direction of the button assembly.
5. A button (70, 270, 370, 470) for a drug delivery device comprising a plate-like button body forming a touch surface (70b, 270b, 370b, 470b), wherein the plate-like button body is coupled by an axial supporting member (75, 275, 375, 475) to a noise-generating interface of the drug delivery device and movable into a longitudinal direction of the drug delivery device, wherein the plate-like button body comprises a material composite with at least one third material component (271, 272, 371, 372, 373, 374, 471) consisting of a third material and at least one fourth material component (278, 378, 478) consisting of a fourth material different from the third material, wherein the at least one third material component (271, 272, 371, 372, 373, 374, 471) and the at least one fourth material component (278, 378, 478) are coupled via at least one coupling plane (270d, 270e, 370d, 470d) that is at least sectionwise slanted or perpendicular to the longitudinal direction.
6. The button of claim 5, wherein the third material has a higher compressive strength than the fourth material and/or a higher inner sound damping than the fourth material and/or a lower viscosity than the fourth material.
7. The button of any of the claims 5 to 6, wherein the at least one coupling plane (270d, 270e, 370d, 470d) runs between the touch surface (270b, 370b, 470b) and the supporting member (75, 275, 375, 475).
8. The button of any of the claims 5 to 7, wherein the supporting member (75, 275, 375, 475) is formed by one third material component.
9. The button of any of the claims 5 to 8 comprising at least two third material components, wherein one third material component is formed by a ring-like cladding element (271) shaped to form the main part of the touch surface (270b) of the button (270), another third material component is formed by a central conical element (272) and one fourth material component is formed by a conical ring-like element (278) accommodated between the ring-like cladding element (271) and the conical element (272).
10. The button of any of claims 5 to 8 comprising a plurality of third material components and a plurality of fourth material components, wherein one third material component is formed by a ring-like cladding element (371), another third material component is formed by a central cylindrical element (372), further third material components are formed by a plurality of cross members (373, 374) running perpendicular to the longitudinal direction and connecting the ring-like cladding element (371) and the central cylindrical element (372) and a plurality of fourth material components is formed by a plurality of polyhedral elements (378) accommodated above and/or below a respective cross member (373, 374) between the cladding element (371) and the central cylindrical element (372).
11. The button of claim 9 wherein a first group of a plurality of cross members (373) forming the proportion of the touch surface (370b) of the button (370) and a second group of the plurality of cross members (374) running offset from the first group of cross members (373) and/or forming at least partly a surface opposite to the touch surface (370b) of the button (370).
12. The button of any of claims 5 to 8 comprising one third material component formed by a plate-like element (471) and one fourth material component formed by a cap (478) covering at least partly the plate-like element (471) and forming at least partly the touch surface (470b) of the button (470).
13. The button of any of the claims 5 to 12, wherein the supporting member is formed by a projection (75, 275, 375, 475) projecting from a central third material component (278, 378, 478) into longitudinal direction.
14. Drive mechanism for a drug delivery device comprising the button (70, 270, 370, 470) of any of the claims 5 to 13 or the button assembly of any of the claims 1 to 4.
15. Drug delivery device comprising the button (70, 270, 370, 470) of any of the claims 5 to 13 or the button assembly of any of the claims 1 to 4 and/or the drive mechanism according to claim 14.
Description
[0098] Non-limiting, exemplary embodiments of the aforementioned working principles will now be described with reference to the accompanying drawings, in which:
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[0118] As indicated above the numbering of the elements and components used in the following description is only used in order to distinguish the elements and components from each other. The numbering does not contain any content regarding the value or significance of the respective element or component.
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[0120] As will be explained in more detail below, the clutch plate 120 is a spring driven rotatable drive member driving the drive sleeve 40 during dose dispensing to rotate relative to the housing 10 to thereby advance piston rod 30. The clutch plate 120 is in turn driven by the number sleeve 60 to which it is rotationally constrained which is attached to one end of the torsion spring 90. On the other hand, although driving the piston rod 30 during dose dispensing, the drive sleeve 40 may be regarded as a driven member because it is driven by the clutch plate 120 (and the number sleeve 60 and the torsion spring 90) during dose dispensing.
[0121] The housing 10 or body is a generally tubular element having a proximal end with an enlarged diameter. The housing 10 provides location for the liquid medication cartridge 100 and cartridge holder 20, windows for viewing the dose number on the number sleeve 60 and the gauge element 110, and a feature on its external surface, e.g. a circumferential groove, to axially retain the dose selector 80. An insert 12 comprises an inner thread engaging the piston rod 30. The housing 10 further has at least one internal, axially orientated slot or the like for axially guiding the gauge element 110. In the embodiment shown in the Fig., the distal end is provided with an axially extending strip partly overlapping cartridge holder 20.
[0122] The cartridge holder 20 is located at the distal side of housing 10 and permanently attached thereto. The cartridge holder may be a transparent or translucent component which is tubular to receive cartridge 100. The distal end of cartridge holder 20 may be provided with means for attaching a needle arrangement. A removable cap (not shown) may be provided to fit over the cartridge holder 20 and may be retained via clip features on the housing 10.
[0123] The piston rod 30 is rotationally constrained to the drive sleeve 40 via a splined interface. When rotated, the piston rod 30 is forced to move axially relative to the drive sleeve 40, through its threaded interface with the insert 12 of housing 10. The lead screw 30 is an elongate member with an outer thread engaging the corresponding thread of the insert 12 of housing 10. The interface comprises at least one longitudinal groove or track at the piston rod 30 and a corresponding protrusion or spline of the driver 40. At its distal end, the lead screw 30 is provided with an interface for clip attachment of the bearing 140.
[0124] The drive sleeve 40 is a hollow member surrounding the lead screw 30 and arranged within number sleeve 60. It extends from an interface with the clutch plate 120 to the contact with the clutch spring 130. The drive sleeve 40 is axially movable relative to the housing 10, the piston rod 30 and the number sleeve 60 in the distal direction against the bias of clutch spring 130 and in the opposite proximal direction under the bias of clutch spring 130. At least one longitudinal spline of the driver 40 engages a corresponding track of the lead screw 30.
[0125] The clutch interface between the drive sleeve 40 and the clutch plate 120 comprises a ring of ratchet (crown) teeth 41 located on the proximal end face of the drive sleeve 40 and a ring of corresponding ratchet (crown) teeth 121 located on the distal end face of the clutch plate 120.
[0126] A splined tooth interface 11, 42 with the housing 10 prevents rotation of the drive sleeve 40 during dose setting. This interface comprises a ring of radially extending outer teeth 42 at the distal end of drive sleeve 40 and corresponding radially extending inner teeth 11 of the housing component 10. When the button 70 is pressed, these drive sleeve 40 to housing 10 spline teeth are disengaged allowing the drive sleeve 40 to rotate relative to housing 10. A further splined tooth interface with the number sleeve 60 is not engaged during dialing, but engages when the button 70 is pressed, preventing relative rotation between the drive sleeve 40 and number sleeve 60 during dispense. In a preferred embodiment this interface comprises inwardly directed splines on a flange on the inner surface of the number sleeve 60 and a ring of radially extending outer splines of drive sleeve 40. These corresponding splines are located on the number sleeve 60 and the drive sleeve 40, respectively, such that axial movement of the drive sleeve 40 relative to the (axially fixed) number sleeve 60 engages or disengages the splines to rotationally couple or decouple the drive sleeve 40 and the number sleeve 60.
[0127] The driver 40 has a threaded section providing a helical track for the nut 50, i.e. a thread. In addition, a last dose abutment or stop is provided which may be the end of the thread track or preferably a rotational hard stop for interaction with a corresponding last dose stop of nut 50, thus limiting movement of the nut 50 on the driver thread.
[0128] A further interface of the drive sleeve 40 comprises the ring of ratchet teeth 41 located at the proximal end face of drive sleeve 40 and the ring of corresponding ratchet teeth 121 on the clutch plate 120.
[0129] The last dose nut 50 is located between the number sleeve 60 and the drive sleeve 40. It is rotationally constrained to the number sleeve 60, via a splined interface. It moves along a helical path relative to the drive sleeve 40, via a threaded interface, when relative rotation occurs between the number sleeve 60 and drive sleeve 40 which is during dialing only. As an alternative, the nut 50 may be splined to the driver 40 and threaded to the number sleeve 60. A last dose stop is provided on nut 50 engaging a stop of drive sleeve 40 when a dose is set corresponding to the remaining dispensable amount of medicament in the cartridge 100.
[0130] The dose indicator or number sleeve 60 is a tubular element. The number sleeve 60 is rotated during dose setting (via dose selector 80) and dose correction and during dose dispensing by torsion spring 90. The number sleeve 60 is axially constrained to the housing 10, e.g. by snap engagement of a bead on an inner housing surface with a groove on an outer number sleeve surface, while being free to rotate relative to the housing 10. The drive spring 90 is attached with one end to the number sleeve 60. Further, the number sleeve 60 is in threaded engagement with the gauge element 110 such that rotation of the number sleeve causes axial displacement of the gauge element 110. Together with gauge element 110 the number sleeve 60 defines a zero position (at rest) and a maximum dose position. Thus, the number sleeve 60 may be seen as a dose setting member. The number sleeve 60 may comprise a number sleeve lower 60a which is rigidly fixed to a number sleeve upper 60b during assembly, e.g. by snap engagement, to form the number sleeve 60.
[0131] Clutch features which have the form of a ring of splines are provided inwardly directed on number sleeve upper 60b for engagement with splines of the button 70 during dose setting and dose correction. A clicker arm is provided on the outer surface of number sleeve 60 which interacts with the drive sleeve 40 and the gauge member 110 for generating a feedback signal. In addition, the number sleeve lower 60a is rotationally constrained to the nut 50 and to the clutch plate 120 via a splined interface comprising at least one longitudinal spline. Further, number sleeve lower 60a comprises an interface for attachment of the torsion spring 90.
[0132] The button 70 forms the proximal end of the device. It may be beneficial if the button 70 is permanently splined to the dose selector 80 by a respective sleeve section 70a fixed at the rim of a plate-like button body projecting into distal direction forming the touch surface 70b. A central stem 72 may extend distally from the proximal face of the plate-like button body as it is shown in
[0133] The dose selector 80 is axially constrained to the housing 10. It is rotationally constrained, via the splined interface, to the button 70. This splined interface which includes grooves interacting with spline features formed by the annular skirt of button 70 remains engaged irrespective of the dose button 70 axial positions. The dose selector 80 or dose dial grip is a sleeve-like component with a serrated outer skirt.
[0134] The torsion spring 90 is attached at its distal end to the housing 10 and at the other end to the number sleeve 60. The torsion spring 90 is located inside the number sleeve 60 and surrounds a distal portion of the drive sleeve 40. The action of rotating the dose selector 80, to set a dose, rotates the number sleeve 60 relative to the housing 10, and charges the torsion spring 90 further.
[0135] The cartridge 100 is received in cartridge holder 20. The cartridge 100 may be a glass ampoule having a moveable rubber bung at its proximal end. The distal end of cartridge 100 is provided with a pierceable rubber seal which is held in place by a crimped annular metal band. In the embodiment depicted in the Fig., the cartridge 100 is a standard 1.5 ml cartridge. The device is designed to be disposable in that the cartridge 100 cannot be replaced by the user or health care professional. However, a reusable variant of the device could be provided by making the cartridge holder 20 removable and allowing backwinding of the lead screw 30 and the resetting of nut 50.
[0136] The gauge element 110 of
[0137] The gauge element 110 has a generally plate or band like component having a central aperture or window and two flanges extending on either side of the aperture. The flanges are preferably not transparent and thus shield or cover the number sleeve 60, whereas the aperture or window allows viewing a portion of the number sleeve lower 60a. Further, gauge element 110 has a cam and a recess interacting with the clicker arm of the number sleeve 60 at the end of dose dispensing.
[0138] The clutch plate 120 is a ring-like component. The clutch plate 120 is splined to the number sleeve 60 via splines. It is also coupled to the drive sleeve 40 via the ratchet clutch interface 41, 121. The ratchet clutch 41, 121 provides a detented position between the number sleeve 60 and drive sleeve 40 corresponding to each dose unit, and engages different ramped tooth angles during clockwise and anti-clockwise relative rotation. A clicker arm may be provided on the clutch plate 120 for interaction with ratchet features of the button 70.
[0139] The clutch spring 130 is a compression spring. The axial position of the drive sleeve 40, clutch plate 120 and button 70 is defined by the action of the clutch spring 130, which applies a force on the drive sleeve 40 in the proximal direction. This spring force is reacted via the drive sleeve 40, clutch plate 120, and button 70, and when at rest it is further reacted through the dose selector 80 to the housing 10. The spring force ensures that the ratchet interface between drive sleeve 40 and clutch plate 120 is always engaged. In the at rest position, it also ensures that the button splines are engaged with the number sleeve splines, and the drive sleeve teeth 42 are engaged with teeth 11 of the housing 10.
[0140] The bearing 140 is axially constrained to the piston rod 30 and acts on the bung within the liquid medicament cartridge. It is axially clipped to the lead screw 30, but free to rotate.
[0141] With the device in the at rest condition as shown in
[0142] The torsion spring 90, which has a number of pre-wound turns applied to it during assembly of the device, applies a torque to the number sleeve 60 and is prevented from rotating by the zero dose abutment.
[0143] The user selects a variable dose of liquid medicament by rotating the dose selector 80 clockwise, which generates an identical rotation in the number sleeve 60. Rotation of the number sleeve 60 causes charging of the torsion spring 90, increasing the energy stored within it. As the number sleeve 60 rotates, the gauge element 110 translates axially due to its threaded engagement thereby showing the value of the dialed dose. The gauge element 110 has flanges either side of the window area which cover the numbers printed on the number sleeve 60 adjacent to the dialed dose to ensure only the set dose number is made visible to the user.
[0144] The drug delivery device further may provide a visual feedback feature in addition to the discrete dose number display typical on devices of this type. The distal end of the gauge element 110 creates a sliding scale through the window in the housing 10. As an alternative, the sliding scale could be formed using a separate component engaged with the number sleeve 60 on a different helical track.
[0145] As a dose is set by the user, the gauge element 110 translates axially, the distance moved proportional to the magnitude of the dose set. This feature gives clear feedback to the user regarding the approximate size of the dose set. The dispense speed of an auto-injector mechanism may be higher than for a manual injector device, so it may not be possible to read the numerical dose display during dispense. The gauge feature provides feedback to the user during dispense regarding dispense progress without the need to read the dose number itself. For example, the gauge display may be formed by an opaque element on the gauge element 110 revealing a contrasting coloured component underneath. Alternatively, the revealable element may be printed with coarse dose numbers or other indices to provide more precise resolution. In addition, the gauge display simulates a syringe action during dose set and dispense.
[0146] The drive sleeve 40 is prevented from rotating as the dose is set and the number sleeve 60 rotated, due to the engagement of its splined teeth 42 with teeth 11 of the housing 10. Relative rotation must therefore occur between the clutch plate 120 and drive sleeve 40 via the ratchet clutch interface 41, 121.
[0147] The user torque required to rotate the dose selector 80 is a sum of the torque required to wind up the torsion spring 90, and the torque required to overhaul the ratchet clutch interface 41, 121. The clutch spring 130 is designed to provide an axial force to the ratchet clutch interface 41, 121 and to bias the clutch plate 120 onto the drive sleeve 40. This axial load acts to maintain the teeth engagement of the clutch plate 120 and drive sleeve 40. The torque required to overhaul the ratchet clutch 41, 121 in the dose set direction is a function of the axial load applied by the clutch spring 130, the clockwise ramp angle of the ratchet teeth 41, 121, the friction coefficient between the mating surfaces and the mean radius of the ratchet clutch interface 41, 121. When overrunning the ratchet teeth 41 of the drive sleeve 40 the clutch plate 120 vibrates back and forth into axial direction thereby hitting the central projection 75 of the button 70 and producing a noise which couples to the surrounding air by the touch surface 70b operating similarly to an air drum. Inventive measures to reduce this noise are described in detail below referring to
[0148] As the user rotates the dose selector 80 sufficiently to increment the mechanism by one increment, the number sleeve 60 rotates relative to the drive sleeve 40 by one ratchet tooth. At this point the ratchet teeth re-engage into the next detented position. An audible click is generated by the ratchet re-engagement, and tactile feedback is given by the change in torque input required.
[0149] Relative rotation of the number sleeve 60 and the drive sleeve 40 is allowed. This relative rotation also causes the last dose nut 50 to travel along its threaded path, towards its last dose abutment on the drive sleeve 40.
[0150] With no user torque applied to the dose selector 80, the number sleeve 60 is now prevented from rotating back under the torque applied by the torsion spring 90, solely by the ratchet clutch interface 41, 121 between the clutch plate 120 and the drive sleeve 40. The torque necessary to overhaul the ratchet clutch 41, 121 in the anti-clockwise direction is a function of the axial load applied by the clutch spring 130, the anti-clockwise ramp angle of the ratchet 41, 121, the friction coefficient between the mating surfaces and the mean radius of the ratchet clutch features 41, 121. The torque necessary to overhaul the ratchet clutch 41, 121 must be greater than the torque applied to the number sleeve 60 (and hence clutch plate 120) by the torsion spring 90. The ratchet ramp angle is therefore increased in the anti-clockwise direction to ensure this is the case whilst ensuring the dial-up torque is as low as possible.
[0151] The user may now choose to increase the selected dose by continuing to rotate the dose selector 80 in the clockwise direction. The process of overhauling the ratchet clutch interface 41, 121 between the number sleeve 60 and drive sleeve 40 is repeated for each dose increment. Additional energy is stored within the torsion spring 90 for each dose increment and audible and tactile feedback is provided for each increment dialed by the re-engagement of the ratchet teeth. The torque required to rotate the dose selector 80 increases as the torque required to wind up the torsion spring 90 increases. The torque required to overhaul the ratchet clutch 41, 121 in the anti-clockwise direction must therefore be greater than the torque applied to the number sleeve 60 by the torsion spring 90 when the maximum dose has been reached.
[0152] If the user continues to increase the selected dose until the maximum dose limit is reached, the number sleeve 60 engages with its maximum dose abutment on the maximum dose abutment of gauge element 110. This prevents further rotation of the number sleeve 60, clutch plate 120 and dose selector 80.
[0153] Depending on how many increments have already been delivered by the mechanism, during selection of a dose, the last dose nut 50 may contact its last dose abutment with stop face of the drive sleeve 40. The abutment prevents further relative rotation between the number sleeve 60 and the drive sleeve 40, and therefore limits the dose that can be selected. The position of the last dose nut 50 is determined by the total number of relative rotations between the number sleeve 60 and drive sleeve 40, which have occurred each time the user sets a dose.
[0154] With the mechanism in a state in which a dose has been selected, the user is able to deselect (correct) any number of increments from this dose. Deselecting a dose is achieved by the user rotating the dose selector 80 anti-clockwise. The torque applied to the dose selector 80 by the user is sufficient, when combined with the torque applied by the torsion spring 90, to overhaul the ratchet interface 41, 121 between the clutch plate 120 and drive sleeve 40 in the anti-clockwise direction. When the ratchet clutch 41, 121 is overhauled, anti-clockwise rotation occurs in the number sleeve 60 (via the clutch plate 120), which returns the number sleeve 60 towards the zero dose position, and unwinds the torsion spring 90. The relative rotation between the number sleeve 60 and drive sleeve 40 causes the last dose nut 50 to return along its helical path, away from the last dose abutment.
[0155] With the mechanism in a state in which a dose has been selected, the user is able to activate the mechanism to commence delivery of a dose. Delivery of a dose is initiated by the user depressing the button 70 axially in the distal direction.
[0156] When the button 70 is depressed using the touch surface 70b, splines between the button 70 and number sleeve 60 are disengaged, rotationally disconnecting the button 70 and dose selector 80 from the delivery mechanism, i.e. from number sleeve 60, gauge element 110 and torsion spring 90. Splines on the button 70 engage with splines on the housing 10, preventing rotation of the button 70 (and hence the dose selector 80) during dispense. As the button 70 is stationary during dispense, it can be used in the dispense clicker mechanism. A stop feature in the housing 10 limits axial travel of the button 70 and reacts any axial abuse loads applied by the user, reducing the risk of damaging internal components.
[0157] The clutch plate 120 and drive sleeve 40 travel axially with the button 70. This engages the splined tooth interface 41, 121 between the drive sleeve 40 and number sleeve 60, preventing relative rotation between the drive sleeve 40 and number sleeve 60 during dispense. The splined tooth interface 11, 42 between the drive sleeve 40 and the housing 10 disengages, so the drive sleeve 40 can now rotate and is driven by the torsion spring 90 via the number sleeve 60, and clutch plate 120.
[0158] Rotation of the drive sleeve 40 causes the piston rod 30 to rotate due to their splined engagement, and the piston rod 30 then advances due to its threaded engagement to the housing 10. The number sleeve 60 rotation also causes the gauge element 110 to traverse axially back to its zero position whereby the zero dose abutment stops the mechanism.
[0159] Tactile feedback during dose dispense may be provided via the compliant cantilever clicker arm integrated into the clutch plate 120. This arm interfaces radially with ratchet features on the inner surface of the button 70, whereby the ratchet tooth spacing corresponds to the number sleeve 60 rotation required for a single increment dispense. During dispense, as the number sleeve 60 rotates and the button 70 is rotationally coupled to the housing 10, the ratchet features engage with the clicker arm to produce an audible click with each dose increment delivered.
[0160] Delivery of a dose continues via the mechanical interactions described above while the user continues to depress the button 70. If the user releases the button 70, the clutch spring 130 returns the drive sleeve 40 to its at rest position (together with the clutch plate 120 and button 70), engaging the splines between the drive sleeve 40 and housing 10, preventing further rotation and stopping dose delivery.
[0161] During delivery of a dose, the drive sleeve 40 and number sleeve 60 rotate together, so that no relative motion in the last dose nut 50 occurs. The last dose nut 50 therefore travels axially relative to the drive sleeve 40 during dialing only.
[0162] Once the delivery of a dose is stopped, by the number sleeve 60 returning to the zero dose abutment, the user may release the button 70, which will re-engage the spline teeth 11, 42 between the drive sleeve 40 and housing 10. The mechanism is now returned to the at rest condition.
[0163] At the end of dose dispensing, additional audible feedback is provided in the form of a click, distinct from the clicks provided during dispense, to inform the user that the device has returned to its zero position via the interaction of the clicker arm on the number sleeve 60 with the ramp on the drive sleeve 40 and the cam and the recess on the gauge element 110. This embodiment allows feedback to only be created at the end of dose delivery and not created if the device is dialed back to, or away from, the zero position.
[0164]
[0165] The button 270 shown in
[0166] The ring-like cladding element 271 and the central conical element 272 form a third material component (see above comment regarding the numbering) of the button 270 whereas the conical ring-like element 278 forms a fourth material component of the body of the button 270. The third material component consists of a third material and the fourth material component consists of a fourth material different from the third material, wherein the third material has a higher compressive strength than the fourth material and/or a higher inner sound damping than the fourth material and/or a lower viscosity than the fourth material. The third material consist of, for example PC, PBT or POM, and the fourth material consists of, for example, one of the above mentioned thermoplastic elastomers.
[0167] The ring-like cladding element 271 and the conical ring-like element 278 are coupled via a first coupling plane 270d that is sectionwise slanted with regard to the axial (longitudinal) direction of the noise. As indicated above the propagation direction of the noise is mainly axially and into proximal direction. Accordingly, the conical ring-like element 278 is coupled with central conical element 272 with a second coupling plane 270e that is sectionwise slanted with regard to the propagation direction of the noise as well. The first and the second coupling plane 270d, e sectionwise form a conical face with regard to the longitudinal direction and comprise some curved sections.
[0168] As one can derive from
[0169] The noise produced by hits of the surface of the clutch plate 220 to the distal end of the projection are damped by passing the fourth material of the fourth material component (ring-like element 278) thereby reducing the noise considerably.
[0170] The embodiments of a button 370, 470 shown in
[0171] The other elements correspond to the respective elements of the embodiment shown in
[0172] The third material component of the embodiment of
[0173] The embodiment of a button 470 shown in
[0174] The coupling planes 370d, 370e, and 470d of the embodiments shown in
[0175] The third material components 371, 372, 373 and 374 consist of the third material and the fourth material components 378, 478 consist of the fourth material. As indicated above, the third material component may consist of PC, PBT or POM, for example, and the fourth material component may consist of one of the above mentioned thermoplastic elastomers. The fourth material component provides the noise damping as explained in detail above with regard to the embodiment of
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[0177] Additionally, the button assembly comprises a dose selector 580 (or, alternatively, a proximal end of the housing) forming a support element. The central stem of the button is accommodated within a respective through hole 581 of the dose selector 580. Further a resilient member in form of a spring 582 (e.g. a compression spring, for example a coil spring) is provided, wherein the plate-like button body is biased by the spring 582 against an axial movement into distal direction. The spring 582 is supported by the distal end face of the plate-like button body 570 and a proximal inner wall surface 584 of the dose selector 580.
[0178] The plate-like button body 570 forming the touch surface 570b of the button comprises further an outer rim 573 at its distal end face projecting from this distal end face in distal direction. Further, the plate-like button body 570 comprises a first material component forming a central section 571 of the plate-like button body 570 and a second material component forming a ring-like outer section 578 of the plate-like button body 570. The ring-like outer section 578 comprises an approximately triangular cross section as shown in
[0179] The plate-like button body 570 shown in
[0180] The central section 571 consists of a first material and the ring-like outer section 578 consists of a second material different from the first material, wherein the second material has a higher elasticity and/or plasticity than the first material. The first material consist of, for example PC, PBT or POM, and the second material consists of, for example, one of the above mentioned thermoplastic elastomers.
[0181] The ring-like outer section 578 and the central section 571 are coupled via a coupling plane 570d that is sectionwise slanted with regard to the axial (longitudinal) direction (see dot and dash line) of the button assembly or drug delivery device.
[0182] As one can derive from
[0183] The material of the ring-like outer section 578 has a higher elasticity and/or plasticity than the central section 571 and provides a shock deactivation mechanism. The shock deactivation mechanism adapted such that in case of a shock event as shown in
[0184] In another embodiment shown in
[0185] The reference number with the same last two numbers have the same function as in the embodiment of
[0186] The embodiment of
[0187] A second state is shown in
[0188] The first state and the second state of the legs 676 of the stem are caused by a deactivation mechanism comprising an acceleration sensor provided within the recess 676a of the stem 675. The acceleration sensor comprises a seismic mass formed by a heavy (e.g. metal) sphere 697 and a compression spring 698 as a resilient member formed by a coil spring. The compression spring 698 is provided with in the recess 676a of the stem 675 such that it presses the metal sphere 697 against a seat 699 (i.e. its resting position) within the recess 676a formed by the two legs 676 at the distal and of the recess 676a. The compression spring 698 is supported at its distal end at the metal sphere 697 and at its proximal end at the proximal end face of the recess 676a.
[0189] The first (normal) state of the legs 676 explained above is realized if the metal sphere 697 is pressed against its seat 699 (resting position) by the compression spring 698 (see
[0190] The second state of the legs 676 is activated when the drug delivery device (and with it the button assembly) falls down and hits a floor (or wall) 690 by the plate-like button body 670 thereby producing a shock force. In this case, as shown in
[0191] Accordingly, in a first state shown in
[0192] In case the drug delivery device falls down and hits the floor 690 (or wall) the acceleration sensor (metal sphere 697, compression spring 698) is activated and prevents a force transmission of an axial shock force acting at the touch surface 670a and caused by the floor 690 (or wall) to the driven element 695 of the drug delivery device (see
[0193] The embodiments of
[0194]
[0195] The sleeve-like button body 770 comprises a material composite with at least one first material component consisting of the first material as indicated above and at least one second material component consisting of a second material as indicated above and different from the first material and having a higher elasticity and/or plasticity than the first material. The second material component forms a ring-like circumferential section 778 of a side surface 774 of the sleeve-like button body 770. The ring-like section 778 has a larger outer diameter than the remaining side surface 774 of the sleeve-like button body 770 forming the first material component. The second material component forms a compressible or collapsible segment. The ring-like section 778 is arranged in a region close to (i.e. in a short distance to) a distal end 780 of the housing 710 which forms the support element, referring to an extended position of the sleeve-like button body 770 shown in
[0196] This embodiment works such that if the button assembly observes a shock force, for example with a force component transversal to the longitudinal direction of the button assembly (see arrow 790 in
[0197] An other embodiment which corresponds with the embodiment shown in
REFERENCE NUMERALS
[0198] 10 housing (casing) [0199] 11 spline tooth [0200] 12 insert [0201] 20 cartridge holder [0202] 30 piston rod (lead screw) [0203] 40 drive sleeve [0204] 41 crown tooth [0205] 42 spline tooth [0206] 50 nut [0207] 60 dose setting element [0208] 60a number sleeve lower [0209] 60b number sleeve upper [0210] 70 button [0211] 70a sleeve section [0212] 70b touch surface [0213] 72 central stem [0214] 75 central projection [0215] 80 dose selector [0216] 90 torsion spring [0217] 100 cartridge [0218] 110 gauge element [0219] 120 clutch plate [0220] 121 crown tooth [0221] 130 clutch spring [0222] 140 bearing [0223] 220, 320, 420 clutch plate [0224] 270, 370, 470 button [0225] 270a, 370a, 470a sleeve section [0226] 270b, 370b, 470b touch surface [0227] 270d, 270e coupling plane [0228] 370d, 370e coupling plane [0229] 271, 371 ring-like cladding element [0230] 272 central conical element [0231] 275, 375, 475 projection [0232] 278 conical ring-like element [0233] 372 central cylindrical element [0234] 373, 374 cross member [0235] 378 polyhedral element [0236] 470d coupling plane [0237] 471 plate-like element [0238] 478 cap [0239] 280, 380, 480 dose selector [0240] 570, 670 plate-like button body (button) [0241] 570b, 670b touch surface [0242] 570d coupling plane [0243] 571 central section [0244] 574 side surface [0245] 578 ring-like outer section [0246] 573, 673 rim [0247] 575, 675 central stem [0248] 579, 679 arrow [0249] 580, 680 dose selector [0250] 581, 681 through hole [0251] 582, 682 coil spring [0252] 584, 684 distal wall surface [0253] 585, 685 proximal end section of the dose selector 580 [0254] 590, 690 floor [0255] 586, 686 stop surface [0256] 676 leg [0257] 676a recess [0258] 676b outer projection (step surface) [0259] 695 driven element [0260] 696 recess of driven element [0261] 697 metal sphere [0262] 698 compression spring [0263] 699 seat (resting position) [0264] 710 housing [0265] 711 needle [0266] 712 activation spring [0267] 770 sleeve-like button body (needle shield) [0268] 770a bendable segment of the sleeve-like button body 770 [0269] 770b touch surface [0270] 770c recess [0271] 774 side surface of the sleeve-like button body [0272] 778 ring-like section [0273] 778a actuation sleeve [0274] 778b rim [0275] 778c spring [0276] 780 distal end of the housing 710 (support member) [0277] 790, 791 arrow