DOSE COUNTING MECHANISM
20220347408 · 2022-11-03
Inventors
- Matthew Richard COTTON (Cambridge, GB)
- Robin Craig COCKER (Cambridge, GB)
- Arlo Christopher BLAIR (Cambridge, GB)
- Ewen Humphrey CHRISTIE (Cambridge, GB)
Cpc classification
A61M15/009
HUMAN NECESSITIES
International classification
Abstract
The present invention relates to dose counting mechanisms for medicament inhaler devices, for example metered-dose inhaler (MDI) devices. In particular, the invention relates to a counter comprising a counting component (20,620), a locking element (46,646) for resisting movement of the counting component (20,620), and a distinct driving element (70,670) for driving movement of the counting component (20,620). The locking and driving elements are actuated by movement of a common element to move the locking element (46,646) out of engagement with the counting component (20,620) and to move the driving element (70,670). The driving element (70,670) applies a motive force to the counting component (20,620) before the locking element (46,646) fully disengages from the counting component (20,620).
Claims
1. An indexing mechanism for a counter, comprising a counting component, a locking element for resisting movement of the counting component and a distinct driving element for driving movement of the counting component, the locking and driving elements having an initial position in which the locking element is engaged with the counting component, and the locking and driving elements being actuated by movement of a common element to move the locking element out of engagement with the counting component and to move the driving element, wherein the driving element applies a motive force to the counting component before the locking element fully disengages from the counting component.
2. The indexing mechanism according to claim 1, wherein engagement of the first element with the counting component prevents movement of the counting component.
3. The indexing mechanism according to claim 1, wherein the driving element is provided on a resilient arm.
4. The indexing mechanism according to claim 3, wherein the resilient arm is deformed on engagement of the driving element with the counting component to store potential energy in the resilient arm.
5. The indexing mechanism according to claim 3, wherein the resilient arm comprises a hinged or bent section.
6. The indexing mechanism according to claim 5, wherein the resilient arm comprises an abutment feature to resist deformation of the hinged or bent section in a first direction.
7. The indexing mechanism according to claim 1, wherein the driving component is out of engagement with the counting component in the initial position, and wherein actuation of the driving element by the common element moves the driving element into engagement with the counting component.
8. The indexing mechanism according to claim 1, wherein the driving element engages with a slot in the counting component.
9. The indexing mechanism according to claim 8, wherein the slot in the counting component comprises a cam surface for engagement with the driving element.
10. The indexing mechanism according to claim 9, wherein the slot in the counting component comprises first and second cam surfaces for engagement with the driving element.
11. The indexing mechanism according to claim 1, further comprising a restoring element providing a biasing force to urge the locking and/or driving element back to the initial position.
12. The indexing mechanism according to claim 11, wherein the restoring element comprises a spring.
13. The indexing mechanism according to claim 12, wherein the spring is a leaf spring.
14. The indexing mechanism according to claim 13, wherein the spring is part of an integrally formed component which also comprises the locking and/or driving element.
15. The indexing mechanism according to claim 1, wherein the locking element engages with a recess in the counting component.
16. The indexing mechanism according to claim 1, wherein the locking and driving elements are provided on separate components.
17. The indexing mechanism according to claim 1, wherein the locking and driving elements are provided on a common component.
18. The indexing mechanism according to claim 1, wherein the counting component is a rotatable component and wherein said movement of the counting element comprises rotation.
19. The indexing mechanism according to claim 18, wherein the rotatable component is a count wheel of a dose counter.
20. The indexing mechanism according to claim 1, wherein movement of the common element comprises depression of the common element.
21. The indexing mechanism according to claim 20, wherein the common element is an MDI canister.
22. A method of indexing a counter comprising, in sequence, the steps of: A. engaging a locking element with a counting component to prevent movement of the counting component; and subsequently B. moving a driving element to apply a motive force the counting component; and C. moving the locking element out of engagement with the counting component; wherein the locking and driving elements are moved in steps B and C by movement of a common element; wherein the driving element applies said motive force to the counting component before the locking element fully moves out of engagement with the counting component; and wherein the driving element drives movement of the counting component once the locking element is fully out of engagement with the counting component.
23. The method of indexing a counter according to claim 22, wherein the locking and driving elements are moved simultaneously in steps B and C.
24. The method of indexing a counter according to claim 22, wherein step B comprises storing energy to drive movement of the counting component.
25. The method of indexing a counter according to claim 22, wherein the counting component is rotatable and wherein the driving element drives rotation of the counting component.
26. The method of indexing a counter according to claim 25, wherein the driving element holds the counting component in a rotated position after driving rotation.
27. The method of indexing a dose counter according to claim 22, comprising the further step of: D. moving the locking element back into engagement with the counting component.
28. The method of indexing a counter according to claim 27, wherein the locking element is moved in step D by a spring biasing force.
29. The method of indexing a counter according to claim 22, wherein movement of the locking and/or driving element comprises rotation around a pivot.
30. The method of indexing a counter according to claim 22, wherein movement of the common element comprises depression of the common element.
31. The method of indexing a counter according to claim 22, using an indexing mechanism for a dose counter, comprising a counting component, a locking element for resisting movement of the counting component and a distinct driving element for driving movement of the counting component, the locking and driving elements having an initial position in which the locking element is engaged with the counting component, and the locking and driving elements being actuated by movement of a common element to move the locking element out of engagement with the counting component and to move the driving element, wherein the driving element applies a motive force to the counting component before the locking element fully disengages from the counting component.
Description
[0039] Practicable embodiments of the invention are described in further detail below with reference to the accompanying drawings, of which:
[0040]
[0041]
[0042]
[0043]
[0044]
[0045]
[0046]
[0047]
[0048]
[0049]
[0050]
[0051]
[0052]
[0053] An exploded view of a press-and-breathe pressurised metered-dose inhaler (pMDI) device 2 is shown in
[0054] The front housing 8 further comprises a window 12 through which a portion of the counter wheel 20 can be viewed, and a mouthpiece 14 providing fluid connection to the medicament canister 6 when the pMDI is assembled. The precise internal geometry of the rear housing 4 to provide the fluid communication and facilitate release of a dose from the canister 6 is unimportant to the present invention, and various suitable configurations will be familiar to a skilled reader. A mouthpiece cover 18 for closing and protecting the mouthpiece 14 is also provided, as is conventional.
[0055] A rear perspective view of the counter wheel 20 is shown in
[0056] The charging feature 24 comprises ten evenly spaced curved fingers 28 defining ten slots 30 therebetween. Each curved finger 28 provides a first camming surface 32 and a second camming surface 34, with each slot 30 provided between the first camming surface 32 of one curved finger 28, and the second camming surface 34 of an adjacent curved finger 28. The curved fingers 28 are shaped so that each slot 30 is wider at an end that is nearest the outer circumference of the counter wheel 20.
[0057] The outer circumference of the disc portion 22 of the counter wheel 20 is provided with ten evenly spaced locking recesses 36, each of which comprises one chamfered edge 38, angled to the radius of the counter wheel 20.
[0058] The various features on the rear of the counter wheel 20, specifically the first and second camming surfaces 32,34 and locking recesses, cooperate with parts of the locking actuator 40 and indexing actuator 60 to provide an indexing system in accordance with the present invention.
[0059] As shown in
[0060] The indexing actuator 60 is shown in
[0061] The indexing arm 68 comprises a hairpin bend 74, hereafter referred to as a hairpin 74, part way along its length, and is thicker at a lower end, adjacent the mounting pin 62, than at the upper end, adjacent the indexing peg 70. A diagonal brace 76 is also provided between the substantially rigid arm 66 and the indexing arm 68, at a position between the mounting pin 62 and the hairpin 74. A first part of the indexing arm 68 therefore has a relatively high rigidity, and a second part is more easily deformable.
[0062]
[0063] Each of the locking actuator 40 and indexing actuator 60 is pivotally mounted to the rear housing 4 at its respective mounting pin 42,62, and the free ends of the spring arms 57,72 are bearing against an inner surface of the rear housing 4. The counter wheel 20 is mounted via its central mounting hole 26 so at to be rotatable relative to the rear housing 4.
[0064] The lower end 16 of a canister 6 can be seen just above the bearing surfaces 50,66 of the locking actuator 40 and indexing actuator 60. In this position, the indexing peg 70 of the indexing actuator 60 is adjacent but spaced from the end on one of the curved fingers 28, and the locking peg 46 of the locking actuator 40 is engaged with one of the locking recesses 36 provided around the edge of the counter wheel 20. The chamfered edge 38 at one side of each of the locking recesses 36 can also be seen clearly in
[0065] Operation of the dose counter will now be described with reference to
[0066] In
[0067] Further downward movement of the lower end 16 of the canister 6 further rotates the indexing actuator 60, causing the indexing peg 70 to move along the first camming surface 32 towards the centre of the counter wheel 20. The locking actuator 40 also continues to rotate, but the locking peg 46 remains in engagement with a locking recess 36. Accordingly, the counter wheel 20 is prevented from rotation, and the indexing arm 68 resiliently deforms as the indexing peg 70 moves along the first camming surface 32. As shown in
[0068] The length of the indexing arm 68 locates the drive peg 70 relatively far from the mounting pin 62 of the of the indexing actuator 60, which serves to amplify movement of the drive peg 70 during operation.
[0069]
[0070] The point at which the locking peg 46 clears the locking recess 36 to unlock the counter wheel 20 represents a commitment point before which depression of the canister 6 will not result in a dose being counted. The location of the locking peg 46 relatively close to the mounting pin 42 of the locking actuator 40 helps to minimise variation of this commitment point due to manufacturing tolerances.
[0071] The rotation of the counter wheel 20 continues until, as shown in
[0072] When pressure on the canister 6 is released, its lower end 16 begins to move vertically upwards clear of the bearing surfaces 50,66 of the locking actuator 40 and indexing actuator 60, as shown in
[0073]
[0074] It will be appreciated that the operation described in
[0075] It will be understood that the indexing arm 68 can be resiliently deformed and stressed during operation by the camming surface 32,34 via compression or extension of the hairpin 74 or simply by bending in the arm 68. Although primarily designed to rely on deformation at the hairpin 74, it is likely that some bending of the arm 68 will also occur. Indeed, it is possible to design an alternative indexing arm that will store elastic potential energy by deforming more equally in both of these modes simultaneously.
[0076] The applicant has also investigated the possibility of using different deformation modes and/or directions to achieve differential spring forces in an indexing arm during its two stages of being stressed. This would allow, for example, a higher spring force to be provided when an indexing arm is deformed during engagement with the first camming surface 32, and a lower spring force to be provided by the same arm during engagement with the second camming surface 34. The energy input for the indexing of the counter wheel 20 needs to be relatively high, to ensure that the indexing operation is reliably completed. In contrast, the spring force during reset of the arm should ideally be as low as possible, since it directly impacts the size and strength of the spring arm required to return the indexing arm under all environmental and/or tolerance conditions, and thus the force that the user must put into depressing the canister 6 and stressing the spring arm during use.
[0077] Some possible alternative indexing actuators for the present invention are illustrated in
[0078]
[0079]
[0080] This indexing actuators 160,260 of
[0081]
[0082] A perspective view of the same indexing actuator 360 in its primed condition is shown in the perspective view of
[0083]
[0084] In the primed condition the stop peg 482 is engaged with the loop 478 by bending the hairpin 474. The engagement of the stop peg 482 with the loop 478 essentially performs a similar function to the end-stop 378 in the third alternative indexing actuator 360, providing a cam track to limit the movement of the indexing peg 70. During depression of the canister 6 the indexing peg 70 cannot move away from the mounting pin 62 through expanding the hairpin 474, because this movement is prevented by the stop peg 482 and loop 478. Movement during the indexing can therefore only be achieved through bending of the indexing arm 468 as the indexing actuator 460 rotates. In contrast, the stop peg 482 can move within the loop 478, towards the mounting pin 62, during reset. The hairpin 474 is therefore free to compress in this mode of operation, which provides a relatively lower spring force. As above, this provides a desirable balance of a larger spring force during indexing, and a lower spring force for reset.
[0085] A final example showing a fifth alternative indexing actuator 560 in moulded and primed configurations is provided with reference to
[0086] In use, radial movement of the indexing peg 70 away from the mounting pin 62, while storing up energy for indexing, quickly causes the end-stops 592 in the second hinge 588 to engage and ‘lock out’ the hinge 588 preventing further opening/expansion. Further movement of the pin is possible only by bending the two limbs of the first branch 568a to open out the ‘V’. This results in a relatively high spring force, sufficient for the indexing operation.
[0087] Radial movement of the indexing pin 70 towards the mounting pin 62, during reset, can be achieved with a relatively lower force, because the end-stops 592 move apart allowing the two hinges 586,588 to collapse the V with minimal bending of either limb of the first branch 568a so that the indexing pin 70 can move down the cam slot 578 under minimal resistance. The necessary restoring force to be provided by the spring arm 72 is therefore minimised.
[0088] It will be understood that the movement of the indexing pin 70 in the fifth alternative indexing actuator 560 regulated by the first branch 568a of the indexing arm 568 and the cam slot 578. The remainder of the indexing arm 568, including the second branch 568b, can be made relatively stiff to minimise bending in the arm 568, so that the behaviour of the indexing actuator 560 under load, and in particular the precise position of the indexing pin 70, is as predictable as possible.
[0089] All of the indexing actuators 60,160,260,360,460,560 described above are intended to be used with a locking actuator 40 substantially as shown and described in
[0090] An alternative embodiment 602 of the invention is shown in an exploded perspective view in
[0091] In a similar manner to the counter wheel 20 of
[0092] As shown in the assembled view of
[0093] In use, a downward pressure is applied to the lever 666 to cause anticlockwise rotation of the indexer 650. The anticlockwise rotation causes a locating peg 682 on the indexing arm 668 to move over a small camming surface 694 on the front plate 608, flexing the end of the indexing arm 668 towards the pivot 626 in the direction indicated by arrow 696. Continued rotation of the indexer 650 brings the indexing tooth 570 into contact with an angled surface of one of the slots 630 which acts as a first camming surface 632 on the counter wheel 620. The locking hook 646 remains engaged with a locking recess 636 at this stage, so that continued anticlockwise rotation of the indexer 650 results in the indexing arm 668 flexing further in the direction of arrow 696.
[0094] When the lever 666 has been depressed sufficiently to rotate the locking hook 646 clear of the locking recess 636 in the counter wheel, the spring force stored in the indexing arm 668 will then be transferred to the counter wheel 620 via the indexing tooth 670, rotating the counter wheel 620 anticlockwise. The disengagement of the locking hook 646 defines a commitment point that would, in practice, be coordinated with the release of a dose from a pMDI canister 6.
[0095] Anticlockwise rotation of the counter wheel 620 is limited by engagement of the indexing tooth 670 with a second camming surface 634 on the opposite side of the slot 630 from the first camming surface 632. Continued downward pressure on the lever 666, indicative of further downward movement of a pMDI canister 6, results in continued rotation of the indexer 650 and moves the indexing tooth within the slot 630. This maintains a rotational position of the counter wheel 620 and provides some dwell time at the end of an indexing operation.
[0096] During subsequent rotation of the indexer 650 in a clockwise direction, the engagement of the indexing tooth 670 in the slot 630 initially maintains the rotational position of the counter wheel 620 until the locking hook 646 engages with the next locking recess 636′. A chamfered edge 638 is provided so that the engagement can to help account for any slight misalignment of the counter wheel 620 if necessary.
[0097] With the counter wheel 620 again locked against rotation, continued movement of the indexing tooth 670 along the second camming surface 634 as the indexer rotates clockwise serves to flex the indexing arm 668 in the opposite direction to arrow 696. This stores energy in the indexing arm 668 so that is springs past the end of the slot 630 once disengaged, ready for a subsequent indexing operation. A coil spring may be provided at the pivot 626 to store energy during the anticlockwise rotation and drive the clockwise rotation of the indexer 650. In a fully realised system, other resilient/spring biasing means, such as a torsion spring or integrated leaf spring(s), may be provided to provide a restorative force to the indexer 650.
[0098] It should be understood that the embodiments described above comprise a single counter wheel for simplicity. The principles described would be scalable for a larger number of doses by using larger wheels with a greater number of slots 30,630 and locking recesses 46,646, or by employing multiple linked count wheels with the described counter wheel 20,620 providing the unit count.
[0099] As noted above, the distance of translation of the canister during depression is relatively small compared to the required movement of the dose-counter wheel. Therefore, it may be beneficial for the distance of movement of the feature that interacts with the counter-wheel, and enables the component to store the required energy for rotation of the counter wheel, to be ‘geared up’ or otherwise amplified. This will help to provide enough movement to effect the necessary index, but may also increase the tolerances on the position of that feature at any given moment. To counteract the poor positional tolerances on this indexing feature, the locking feature of the mechanism—which sets the trigger-point for the indexing of the counter wheel relative to the position of the canister—can be kept as a separate feature, and situated close to its axis of rotation (or other point joining it to the chassis) to ensure good tolerances and good positional control of the trigger-point.
[0100] Once the trigger-point has been reached, and the indexing feature has indexed the counter wheel, there are a variety of possible ways in which the counter wheel can be stopped in the desired angular position: [0101] The indexing feature can be allowed to stop in its natural, unstressed position; [0102] To improve the angular positioning of the previous option, the path of the indexing feature can be planned in such a way that its final movements are substantially radial relative to the counter wheel, and/or interact with a cam profile such that said final movements do not induce rotation in the counter wheel, meaning that loose tolerances on the final position of the indexing feature can be translated to tight tolerances on the angular position of the counter wheel; [0103] The indexing feature, or another feature of the component on which it is borne, may be designed to hit an end-stop that positions it—and thus the counter wheel—more closely than relying on the final position of the loosely-toleranced indexing feature; [0104] The locking feature may function as a form of escapement, both releasing and catching the counter wheel to provide a tightly-toleranced end-stop to its rotation; this would probably involve two instances of indexing movement per complete index of the counter wheel.
[0105] Various other modifications would also be apparent to a skilled reader. As such, it is emphasised that the forgoing description is provided by way of example only, and is not intended to limit the scope of protection as defined with reference to the appended claims.
[0106] Examples of alternative configurations include reversing the direction of rotation of the counter wheel, reversing the direction of radial movement of the indexing peg/tooth (i.e. from towards the centre of the counter wheel toward its outer edge) and/or providing a similar dual charge/release system in a non cam-driven system, for example using a more direct, tangential driving of the counter wheel.