Drive Mechanism for use in a Drug Delivery Device
20170319784 · 2017-11-09
Inventors
- William Geoffrey Arthur Marsh (Buckinghamshire, GB)
- Matthew Meredith JONES (Warwick, Warwickshire, GB)
- Joseph Butler (Rugby Warwickshire, GB)
- Anthony Paul Morris (West Midlands, GB)
Cpc classification
A61M2005/31518
HUMAN NECESSITIES
A61M5/31541
HUMAN NECESSITIES
A61M5/31593
HUMAN NECESSITIES
A61M5/31511
HUMAN NECESSITIES
A61M2005/2026
HUMAN NECESSITIES
A61M5/3157
HUMAN NECESSITIES
A61M5/2033
HUMAN NECESSITIES
A61M2205/585
HUMAN NECESSITIES
A61M5/31585
HUMAN NECESSITIES
A61M5/2422
HUMAN NECESSITIES
A61M5/31536
HUMAN NECESSITIES
International classification
A61M5/20
HUMAN NECESSITIES
A61M5/24
HUMAN NECESSITIES
Abstract
The disclosure is directed to a drive mechanism for use in a drug delivery device having a cartridge, the mechanism comprising a base element, a toothed piston rod movable from a first retracted position corresponding to a full cartridge to a second extended position corresponding to an empty cartridge, wherein the piston rod is guided within and movable relative to the base portion, and a drive gear having a pinion, which is rotatably held in the base element and in meshed engagement with the toothed piston rod, wherein the toothed piston rod comprises multiple rigid rod pieces which are connected by hinges, and a drive spring, which is fixed to the base element with one end and fixed to the drive gear with another end and which exerts a force or torque to the drive gear for rotating the drive gear relative to the base element, which rotation results in a movement of the toothed piston rod. The drive spring is charged during manufacture or assembly, wherein the energy stored in the drive spring is sufficient to move the piston rod (from the first to the second position. The disclosure is also directed to a drug delivery device.
Claims
1-15. (canceled)
16. A drive mechanism for use in a drug delivery device having a cartridge, the mechanism comprising: a base element, a toothed piston rod movable from a first retracted position corresponding to a full cartridge to a second extended position corresponding to an empty cartridge, wherein the piston rod is guided within and movable relative to the base portion, and a drive gear having a pinion, which is rotatably held in the base element and in meshed engagement with the toothed piston rod, wherein the toothed piston rod comprises multiple rigid rod pieces which are connected by hinges, and a drive spring, which is fixed to the base element with one end and fixed to the drive gear with another end and which exerts a force or torque to the drive gear for rotating the drive gear relative to the base element, which rotation results in a movement of the toothed piston rod, wherein the drive spring is charged during manufacture or assembly, wherein the energy stored in the drive spring is sufficient to move the piston rod from the first to the second position.
17. The drive mechanism according to claim 16, wherein the drive gear comprises at least two separate components that are rotationally fixed and axially movable relative to each other.
18. The drive mechanism according to claim 16, wherein the drive gear is axially displaceable and rotationally fixed with respect to the pinion.
19. The drive mechanism according to claim 16, wherein a compression spring is arranged between the pinion and the drive gear.
20. The drive mechanism according to claim 16, wherein the drive spring is a power spring or a torsion spring.
21. The drive mechanism according to claim 16, comprising a clutch provided by a splined portion of the drive gear and a corresponding splined portion of the base element, wherein the drive gear is axially movable along its rotational axis between a first position in which the drive gear is rotationally constrained to the base element by engagement of the clutch and a second position in which the clutch is disengaged and relative rotation between the base element and the drive gear is allowed.
22. The drive mechanism according to claim 21, comprising a compression spring arranged to bias the drive gear into its first position relative to the base element.
23. The drive mechanism according to claim 22, further comprising a trigger being axially movable in the direction of the axis of rotation of the drive gear, wherein actuation of the trigger results in an axial movement of the drive gear into its second axial position.
24. The drive mechanism according to claim 16 further comprising a setting element rotatable relative to the base element, wherein rotation of the setting element relative to the base element is limited by rotational stops defining a zero dose position and also a maximum dose position; and wherein the drive gear is configured to engage the setting element when moved from the first into the second position such that the setting element is rotationally constrained to the drive gear.
25. The drive mechanism according to claim 24, wherein the setting element is configured as a number wheel provided with a series of markings on an outer circumference.
26. A drug delivery device comprising a drive mechanism comprising: a base element, a toothed piston rod movable from a first retracted position corresponding to a full cartridge to a second extended position corresponding to an empty cartridge, wherein the piston rod is guided within and movable relative to the base portion, and a drive gear having a pinion, which is rotatably held in the base element and in meshed engagement with the toothed piston rod, wherein the toothed piston rod comprises multiple rigid rod pieces which are connected by hinges, and a drive spring, which is fixed to the base element with one end and fixed to the drive gear with another end and which exerts a force or torque to the drive gear for rotating the drive gear relative to the base element, which rotation results in a movement of the toothed piston rod, wherein the drive spring is charged during manufacture or assembly, wherein the energy stored in the drive spring is sufficient to move the piston rod from the first to the second position and; further comprising a dose setting member for setting user variable doses of a medicament and rotatable relative to the base element wherein the dose setting member and the setting element respectively comprise spline features configured to engage corresponding spline features on a trigger in a first axial position of the trigger such that the trigger rotationally constrains the setting element to the dose setting member.
27. The drug delivery device according to claim 26, wherein movement of the trigger from the first into a second axial position rotationally decouples the trigger from the dose setting member and the setting element.
28. The drug delivery device according to claim 27, further comprising a feedback mechanism generating an audible and/or tactile feedback at the end of dose dispensing, the feedback mechanism comprising a flexible clicker arm on the base element configured to override a protrusion on the setting element to produce the audible and/or tactile feedback, wherein when the drive gear is in a second position, in which relative rotation between the drive gear and the base element is allowed, the drive gear engages the clicker arm in such way that the effective length of the clicker arm is reduced.
29. The drug delivery device according to claim 26, wherein the cartridge contains a medicament.
30. The drug delivery device according to claim 26, wherein the device is a disposable injection device.
Description
BRIEF DESCRIPTION OF THE FIGURES
[0064] Certain embodiments will now be described in further detail with reference to the accompanying schematic drawings, wherein
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DETAILED DESCRIPTION
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[0080] As shown in
[0081] As the detailed views in
[0082] The drive spring 130 is provided in the form of a helical torsion spring and is attached at one end to the chassis 30 and at the other end to the drive gear 110. The drive spring 130 is charged for life, which means that the drive spring is fully charged during assembly and does not require charging by the user until the entire content of the cartridge 140 is dispensed.
[0083] The drive gear 110 is axially constrained between the chassis 30 and number wheel 100 and biased away from the chassis 30 by the trigger spring 80 that is provided in the form of a compression spring. It travels axially with the button 40 when the button 40 is pressed to commence dose delivery. During dose selection, the drive gear 110 is in splined engagement with the chassis 30 and hence locked against rotation, but when it travels axially as the button 40 is depressed downwardly for dose delivery this spline engagement is disconnected. Similarly, the separate spline features between the number wheel 100 and the drive gear 110 are engaged when the button 40 is depressed. The trigger spring 80 applies a force between the chassis 30 and drive gear 110 to separate them. In an “at rest” condition, prior to pressing the button 40, this ensures that the drive gear 110 is rotationally coupled to the chassis 30 and that the button splines 42 are engaged with the dial 50.
[0084] The flexible piston rod 120 is located within the chassis 30 and is engaged with the drive gear 110 via a rack and pinion interface so that counter-clockwise (CCW) rotation of the drive gear 110 advances the flexible piston rod 120 towards a bung in the cartridge 140. The pinion 114 is rotatably held in the chassis 30 and is in meshed engagement with the piston rod 120. The piston rod 120 is a single component with discrete rigid rod pieces or segments 121 connected together by thin sections of material which form flexible hinges 122. The end faces of the segments 121 are planar and, when the piston rod 120 is straightened the adjacent segment faces abut each other, allowing the component to withstand a compressive load. Segments 121 are shaped as a flat plate provided with rack teeth 123 on one side and a flange on the opposite side. The segment facing towards the cartridge comprises a pressure foot for contacting the cartridge bung. As the piston rod 120 is advanced, via the rack 123 and pinion 114 engagement with the drive gear 110, the trailing segments 121 of piston rod 120 are drawn into engagement with the drive gear pinion 114. The subsequent segments 121 drive the preceding segments, loading them in compression, and apply a force to the bung. As the piston rod 120 advances, the first segment moves out of a support provided by the chassis 30. Without additional support it is likely that the piston rod 120 would buckle under this compressive loading. The additional support to prevent buckling is created by the inner side wall of the cartridge 140 providing constraint to the outer surfaces of the piston rod 120.
[0085] The distal end of the flexible piston rod 120 acts on a bung within the liquid medicament cartridge. The liquid medicament cartridge 140 is housed within the cartridge holder 20. The cartridge holder 20, chassis 30 and outer/upper casework 13 and lower casework 14 and the prism 90 are fixed rigidly relative to one another.
[0086] The drug delivery device can be operated to deliver a number of user variable doses of medicament from the cartridge 140, via a needle (not shown). The device is disposable and is delivered to the user in a fully assembled condition ready for use. The mechanism provides separate user interfaces for setting and delivery of a dose. In short terms, a dose is set by rotating dial 50 located on the face of the device. Delivery of a dose is initiated by pressing dose button 40, positioned in the centre of the dial 50, and dose delivery will continue while the dose button 40 remains depressed, until the complete set dose has been delivered. The mechanism provides audible, visual and tactile feedback, all three on the setting and delivery of each dose. Any dose size can be selected between zero and a pre-defined maximum, in increments to suit the medicament and user profile. The mechanism permits cancelling of a dose without any medicament being dispensed by rotation of the dial 50 in the opposing direction to when selecting a dose.
[0087] The force required to actuate the dose button 40 and the distance which it has to move are small, providing a significant ergonomic advantage, particularly for those users with impaired dexterity. The mechanism requires consistent user input forces to set a dose and initiate the delivery of a dose, which are insensitive to variations in the force required to displace the bung within the cartridge 140. The dial 50 is disengaged during dose delivery so that it does not rotate, which improves handling of the device during use. The device has relatively low part count, very compact size and is particularly attractive for cost sensitive device applications.
[0088] In the following use and function of the device will be described in more detail.
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[0090] To dial a variable dose of liquid medicament, the user rotates the dial 50 in clockwise (CW) direction. The spline features provided on the underside of the dial, and on the button and the number wheel are engaged (see
[0091] In
[0092] In
[0093] In
[0094] In
[0095] The drive gear 110 moves axially with the button 40 against the force of the trigger spring 80, and when the button 40 is partially depressed (
[0096] After the button 40 is fully depressed, the drive gear 110 and the number wheel 100 are rotationally locked and free to rotate under the action of the drive spring 130. The button 40 is disengaged from all spline teeth and therefore the mechanism can rotate relative to the button 40 and the dial 50.
[0097] The pinion 114 of the drive gear 110 acts on the teeth of the piston rod 120 causing the medicament to be dispensed. At the end of dose, the number wheel 100 zero stop abutment stops against the stop feature in the outer casework 13 causing the mechanism to stop. During delivery of a dose, the drive gear 110 and the number wheel 100 rotate together, so that no relative motion in the last dose nut 60 occurs.
[0098] The dose delivery clicker arm is a compliant cantilever beam integrated into the chassis 30, which interfaces axially with ratchet features on the drive gear 110 (not shown). The ratchet teeth spacing corresponds to the drive gear 110 rotation required to deliver a single dose unit. During dispense, as the drive gear 110 rotates, the ratchet features engage with the clicker arm to produce an audible click with each dose unit delivered.
[0099] When the button 40 is released, the trigger spring 80 causes the drive gear 110 and hence the button 40 to travel axially to their at-rest position. This travel causes the drive gear 110 spline teeth 113 to mesh with the chassis 30 again, locking the drive gear 110 against further rotation. The drive gear 110 also disengages its spline teeth 111 from the number wheel 100. The button 40 then re-engages its spline teeth features 42 and 43 with the dial 50 and the number wheel 100. The user is then free to dial their next dose when required.
[0100] In
[0101] In
[0102] Instead of a torsion spring, a power spring may be assembled.
[0103] The embodiment shown in
[0104] The lower component 119b does not move axially and secures the inner leg of the power spring 130. It also contains the pinion 114 that drives the flexible piston rod 120. The upper drive gear component 119a moves axially with the button travel relative to the second drive gear component 119b and interfaces with the number wheel 100 and the last dose nut 60. Alternatively, the pinion 114 may be part of an arbor that constitutes the second component. The two parts 119a and 119b are biased apart by the trigger spring 80, which also gives the advantage that during dose delivery, since both components are rotating together, the spring does not add any frictional losses that the drive spring 130 must overcome. When the button is actuated, which means that the button 40 is moved in downward direction so that the clutch between the drive gear 110 and the number wheel 100 is released, the trigger spring is compressed.
REFERENCE NUMERALS
[0105] 1 drug delivery device [0106] 10 body (casework) [0107] 13 upper casework [0108] 14 lower casework [0109] 20 cartridge holder [0110] 30 chassis (base element) [0111] 31 spline teeth [0112] 36 clicker arm [0113] 40 dose button [0114] 42 spline teeth [0115] 43 spline teeth [0116] 50 dial (dose setting member) [0117] 51 dial cover [0118] 52 spline teeth [0119] 54 dial clicker [0120] 55 dial clicker [0121] 60 last dose nut [0122] 62 outer thread [0123] 64 splined interface [0124] 80 trigger spring [0125] 90 prism [0126] 100 number wheel (setting element) [0127] 101 maximum stop [0128] 102 zero stop [0129] 103 spline teeth [0130] 104 spline teeth [0131] 105 end stop [0132] 106 protrusion [0133] 110 drive gear [0134] 111 spline teeth [0135] 112 helical teeth [0136] 113 spline teeth [0137] 114 pinion [0138] 117 Axis of rotation of drive gear [0139] 119a first drive gear component [0140] 119b second drive gear component [0141] 120 flexible piston rod [0142] 121 segment (rigid rod piece) [0143] 122 hinge [0144] 123 rack teeth [0145] 130 drive spring [0146] 140 cartridge