Non-axial working end-of content mechanism and an injection device comprising the same
10328210 ยท 2019-06-25
Assignee
Inventors
- Simon Munch Pedersen (Copenhagen N, DK)
- Carsten Soerensen (Frederiksberg, DK)
- Simon Roervig (Copenhagen OE, DK)
Cpc classification
A61M5/20
HUMAN NECESSITIES
Y10T74/20654
GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
A61M5/31541
HUMAN NECESSITIES
International classification
A61M5/315
HUMAN NECESSITIES
Abstract
The invention relates to a non-axial working End-of-Content mechanism which is geared by a hypocycloid gearing. The EoC mechanism comprises a first element (30, 109) having a first internal surface (36, 136) with a first internal diameter (D), and an EoC element (50, 150) having a second external surface (56, 156) with a second external diameter (d) being smaller that the first internal diameter (D). The EoC element (50, 150) is located inside the first internal diameter (D) of the first element (30, 109) and the first element (30, 109) and the EoC element rotates relatively to each other in a gearing ratio. The EoC element (150, 150) thus operating as the inner rolling circle of a hypocycloid counting the numbers of relative rotations. The EoC mechanism further has stopping means (45, 55; 113, 155)) provided for stopping the relative rotation in a predetermined position which position correlates to the initial injectable content of drug in the injection device such that a user cannot at any time set a dose larger than the quantum left in the injection device at any time.
Claims
1. A pen-shaped injection device for delivering set doses of a liquid drug comprising: a torsion spring which is strained when setting a dose and released to drive a piston rod forward during dose expelling and the injection device further comprises a non-axial working End-of-Content (EoC) mechanism comprising: a first element having a first internal surface with a first internal diameter (D), an EoC element having a second external surface with a second external diameter (d) being smaller that the first internal diameter (D) and the EoC element is located inside the first internal diameter (D) of the first element, wherein the first element has a first centre axis (X), and the EoC element has a second centre axis (Y) not coaxial in relation to the first centre axis (X) and wherein the second external surface of the EoC element engages with the first internal surface of the first element, wherein the first element and the EoC element rotates relatively to each other in a gearing ratio, wherein stopping structure is provided for stopping the relative rotation of the first element and the EoC element in a predetermined position, whereby a dose size exceeding the remaining injectable content of liquid drug cannot be set, wherein the EoC element rotates on a cam provided on a third element during dose setting, wherein the third element carrying the cam is rotated to set a dose and the first element is kept inrotatable during dose setting, and wherein the EoC mechanism has no components operating in the axial direction when counting.
2. An injection device for delivering set doses of a liquid drug comprising a torsion spring which is strained when setting a dose and released to drive a piston rod forward during dose expelling and the injection device further comprises a non-axial working End-of-Content (EoC) mechanism comprising: a first element having a first internal surface with a first internal diameter (D), an EoC element having a second external surface with a second external diameter (d) being smaller that the first internal diameter (D) and the EoC element is located inside the first internal diameter (D) of the first element, wherein the first element has a first centre axis (X), and the EoC element has a second centre axis (Y) not coaxial in relation to the first centre axis (X) and wherein the second external surface of the EoC element engages with the first internal surface of the first element, wherein the first element and the EoC element rotates relatively to each other in a gearing ratio, wherein stopping structure is provided for stopping the relative rotation of the first element and the EoC element in a predetermined position, whereby a dose size exceeding the remaining injectable content of liquid drug cannot be set, wherein the EoC element rotates on a cam provided on a third element during dose setting, wherein the third element carrying the cam is rotated to set a dose and the first element is kept inrotatable during dose setting, and wherein the EoC mechanism has no components operating in the axial direction when counting.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) The invention will be explained more fully below in connection with a preferred embodiment and with reference to the drawings in which:
(2)
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(13)
(14) The figures are schematic and simplified for clarity, and they just show details, which are essential to the understanding of the invention, while other details are left out. Throughout, the same reference numerals are used for identical or corresponding parts.
DETAILED DESCRIPTION OF EMBODIMENT
(15) When in the following terms as upper and lower, right and left, horizontal and vertical, clockwise and counter clockwise or similar relative expressions are used, these only refer to the appended figures and not to an actual situation of use. The shown figures are schematic representations for which reason the configuration of the different structures as well as there relative dimensions are intended to serve illustrative purposes only.
(16) In that context it may be convenient to define that the term distal end in the appended figures is meant to refer to the end of the injection device which usually carries the injection needle whereas the term proximal end is meant to refer to the opposite end pointing away from the injection needle and usually carrying the dose dial button.
(17)
(18)
(19) The basic elements of this injection device are: A housing 1 encompassing the various components, A scale drum 2, which visually informs the user of the dose size through a window 3 in the housing 1. The scale drum 2 is preferably threaded to the housing 1 via an external thread 4 and splined to the drive tube 30 via a longitudinal recess 31 in the drive tube 30 such that the scale drum 2 rotates with the drive tube 30 and performs a helical movement in relation to the housing 1. A dose setting button 10 which is rotatable mounted to the housing 1 at a proximal end and by which button 10 the user can set and adjust the size of the dose to be injected. A piston rod 20 for moving a plunger forward inside a cartridge containing the liquid drug to be injected. The piston rod 20 has a thread 21 on its outer surface and is further provided with a longitudinal extending track or similar not circular outer cross section 22.
(20) The drive tube 30 is connected to a torsion spring 5 which proximally is secured to a spring base 9. The spring base 9 is inrotatable retained in the housing 1 such that the torsion spring 5 is strained when the drive tube 30 is rotated via the dose setting button 10.
(21) Distally, the housing 1 is provided with a nut element 6. This nut element 6 is in the disclosed example moulded as an integral part of the housing 1, but could alternatively be provided as a separate part inrotatable retained in the housing 1. The nut element 6 has an internal thread 7 engaging the outer thread 21 of the piston rod 20. Further the nut element 6 rotatable supports a piston rod guide 25.
(22) The piston rod guide 25 engages the longitudinal track 22 of the piston rod 20 such that rotation of the piston rod guide 25 is transferred to a rotation of the piston rod 20. Once the piston rod 20 is rotated it is screwed forward in the thread 7 of the nut element 6.
(23) A clutch 40 slides on an outside surface of the nut element 6 as disclosed in
(24) During injection the clutch 40 is axially moved in the proximal direction; out of engagement with the nut element 6 and into engagement with the drive tube 30 such that the torque in the torsion spring 5 rotates the drive tube 30, the clutch 40 and the piston rod guide 25 together which results in rotation of the piston rod 20 thus moving the piston rod 20 in the distal direction.
(25) As the clutch 40 moves axially when shifting from the dose setting mode (
(26) The non-axial working End-of-Content mechanism itself is further disclosed in
(27) As in
(28) During injection, the clutch 40 is moved proximally (as indicated by the arrow I in
(29) In the second embodiment depictured in the
(30)
(31)
(32) The various engagement of the drive tube 30 is as follows;
(33) The distally provided teeth 35 engage the teeth 51 on the EoC ring 50 in both the dose setting mode and in the dose injection mode.
(34) The next ring of teeth 32 engages the teeth 42 on the clutch 40 when in the dose injection mode. In the dose setting mode no engagement is present but the internal teeth 44 on the clutch 40 engage with the nut element 6.
(35) In the dose setting mode the proximal ring of teeth 32 engages similar teeth provided on the second clutch element 15. In the dose injection mode this engagement is released by proximal movement of the second clutch 15.
(36) The further ring of teeth 33 is in contact with arms provided on the second clutch element 15 to produce a click-sound when the drive tube 30 rotate relative to the second clutch element 15, which it does during dose expelling.
(37) The clutch 40 disclosed in
(38) Distally to the cam 43 the clutch 40 is externally provided with a cut-out 45 which is to be engaged by the hook 55 of the EoC ring 50 as will be explained later.
(39) Further, the EoC ring 50 has an external surface 56 having an external diameter (d) which is smaller than the internal diameter (D) of the internal surface 36 of the drive tube 30 thus making the connection between the EoC ring 50 and the drive tube 30 operate as a hypocycloid gearing as schematically shown in
(40) The EoC ring 50 disclosed in
(41) Internally the EoC ring 50 has a circular rim 54 which engages the eccentric cam 43 of the clutch 40 such that the EoC ring 50 is able to rotate around the extending tube 41 with a centre line Y which is dislocated from the centre line X of the injection device.
(42) The principle of the hypocycloid geared EoC mechanism is shown in
(43) In the example in
(44) The example disclosed in
(45) In the example of
(46) The angular distance between each valley 34 is (360/26): 13.85 degrees as there are 25 steps (usable valleys 34) plus the missing valley of the double tooth 37, all together 26 steps (valleys).
(47) The single tooth 53 carried by the flexible arm 52 therefore has to move (360+360/26) 373.85 degree for each full revolution (360 degree) of the drive tube 30. This is done by having a gearing modulus of (373.85/360)=1.0385.
(48) The effect of this gearing is that for each full revolution (360 degrees) of the drive tube 30 the EoC ring 50 rotates 373.85 degrees in the same rotational direction and the single tooth 53 is delivered into the next consecutive valley 34b. This can be done 25 times before the single tooth 53 reaches the 26th blocked out valley of the double tooth 37.
(49) In
(50) The EoC ring 50 is provided with a suitable number of externally pointing teeth 51 in order for the EoC ring 50 to be properly rotated by the drive tube 30. In the example in
(51) As can be best seen from
(52) As disclosed in
(53) As the drive tube 30 has 26 valleys (and teeth) and the EoC ring has 25 teeth, the ratio of the teeth is (26/25)=1.04. Since the number of teeth, so to speak, predominates the diameter, meaning that the rotation of the EoE ring 50 is given more by the teeth ratio than the diameter (angular) ratio, this discrepancy in the tooth ratio (1.04) and the angular ratio (1.0385) actually make the EoC ring 50 rotate a little more than the mathematically required 373.85 degree. The actual rotation is (3601.04)=374, 4 degrees, which is 0.55 degrees to many per revolution. As there is 25 revolutions, the EoC ring moves (250.55)=13.75 degrees to much which again equals one extra valley. The result being that the EoC ring 50 is stopped to early. However, this can be resolved by providing an extra valley, such that the drive tube 30 has 27 valleys (=26 steps).
(54) The hypocycloid EoC mechanism of the first embodiment works as follows;
(55) When setting a dose (
(56) When the set dose is expelled, the clutch 40, the drive tube 30 and the EoC ring 50 rotates together such that the relative position between the three parts (40, 30, 50) are maintained. The angular position of the single tooth 53 inside the drive tube 30 at any given time is thus an expression of the accumulated number of set doses. The doses set in previous dose settings has of course been expelled, the counting is thus the already set and expelled doses+the latest setting.
(57) When the drive tube 30 has been rotated 25 full rotations, the single tooth 53 encounters the double tooth 37 of the drive tube 30 and the single tooth 53, the flexible arm 52 and the hook 55 are lifted radially inwards. In this inwardly bended position, the hook 55 will engage with the cut-out 45 in the clutch 40 during the rotation. Since the clutch 40 is kept inrotatable during dose setting, the engagement between the hook 55 and the cut-out 45 of the clutch 40 will prevent further rotation of the EoC ring 50 and thereby also prevent further rotation of the drive tube 30, thus preventing further dose setting.
(58) Leading up to the cut-out 45 a ramp 46 is provided such that when the hook 55 on the last part of the last rotation encounters the double tooth 37 sufficient space is provided to begin the radially inwards movement of the hook 55. Since both the drive tube 30 and the EoC element 50 rotate together, however with the EoC ring 50 moving a little faster, the abutment between the single tooth 53 and the double tooth 37 will happen graduately on the last part of the rotational movement.
(59) The above example is for illustration only. The hypocycloid geared EoC mechanism can be made with any size of internal diameter (D) and internal diameter (d) and with any suitable number of teeth and with any suitable angular position of the teeth.
(60) Further, as the EoC mechanism in the example is designed for a maximum of 25 full rotations it can easily be assembled with the single tooth 53 in a different initial starting position. If e.g. the single tooth 53 is pre-mounted to start in a different valley 34 (e.g. in the valley named 34d) such that the single tooth 53 only has to climb 11 valleys 34 before reaching the double tooth 37, the drive tube 30 can thus be rotated 12 full rotations. At the same time the cut-out 45 of the clutch 40 can be arranged opposite thereby further adding a half rotation to the 12 full rotations. Such design is particular suitable for an injection device containing 300 I.U. of insulin and 24 increments per full rotation (2412.5=300). Such an injection device could e.g. contain 3 ml of a U100 insulin.
(61) In this manner it is possible to use only a part of the valleys 34 or to use a different modulus for the hypocycloid gearing thus designing the EoC mechanism for the relevant drug and the relevant number of strength and doses.
(62)
(63) In the second embodiment, the EoC mechanism has been moved to the proximal end of the injection device 1 and configured slightly different as will be explained. In the first embodiment the cam 43 is carried by the clutch 40 whereas, since the EoC mechanism has been moved proximally in the second embodiment, the cam 143 is in the second embodiment carried by the second clutch 115.
(64) The second clutch element 115 (third element in this embodiment) is proximally provided with a ratchet arm 116 which engages a first toothing 111 in the spring base 109. The spring base 109 is retained in the housing 1 as in the first embodiment, however in this second embodiment the spring base 109 operates as the first element. The clutch 115 and the spring base 109 have a centre axis X.
(65) The spring base 109 is further provided with a second toothing 135 which engages with the toothing 151 of the EoC ring 150. As in the first embodiment, the toothing 135 defines valleys 134 and is carried on the internal surface 136 of the spring base 109 having a diameter (D), and the toothing 151 of the EoC ring 150 defines an external surface 156 having a diameter (d).
(66) The spring base 109 is further provided with an internal tower 112 having a longitudinal opening 113. The longitudinal opening 113 is utilized to stop the rotation of the EoC ring 150 as will be explained.
(67) The clutch 115 is further provided with an eccentric cam 143 having a centre axis Y which is dislocated in relation to the centre axis X. As in the first embodiment, the injection button 10 engages the second clutch 115 which is rotated during dose setting.
(68) The EoC ring 150 of the second embodiment is further disclosed in
(69) As can be seen in
(70) During injection the second clutch 115 is moved axially in the proximal direction against the force of the spring arm 118. This is the same functionality as in the first embodiment where the clutch 15 is pushed proximally by a non-shown needle shield. This proximal movement is conveyed to the second clutch 15 (115 in the second embodiment). In the dose setting mode, the spring arm 118 urges the second clutch in the distal direction.
(71) The hypocycloid EoC mechanism of the second embodiment works as follows;
(72) Each time the EoC ring 150 is rotated a specific tooth 153 is moved from one prior valley 134a to the next consecutive valley 134b. However in the first embodiment the single tooth 53 was moved 373.85 degrees for each rotation of the first element (drive tube 30) as the ratio was calculated to 1.0385.
(73) In the second embodiment however the rotating part is the second clutch 115 carrying the eccentric cam 143. The spring base 109 (first element) is inrotatable secured in the housing 1. Rotation of the second clutch 115 and the cam 143 in the clockwise direction as indicated by the arrow C makes the EoC ring 150 rotate in the opposite direction (counter-clockwise, indicated by the arrow D). Since the rotational direction is opposite 360 degrees must be deducted from the 373.85 degrees required if the rotational direction is the same as in the first embodiment. The result is that the EoC ring 150 rotates (373.85360) 13.85 degrees (in the opposite direction) for each 360 degrees rotation of the second clutch 115.
(74) If, in a thought and non-shown example, the spring base 109 could be the rotational part, which in
(75) In
(76) In the second embodiment, the start position of the specific tooth 153 together with the start position of the cut-out 117 in the second clutch 115 (both positions seen in relation to the longitudinal opening 113 in the tower 112 of the spring base 109) defines the number of steps the EoC ring 150 is allowed to make before it is stopped and further relative rotation between the EoC ring 150 and the spring base 109 is prevented. As the EoC ring 150 rotate one step for each full rotation of the second clutch 115, the stop function applied between the EoC ring 150 and the spring base 109 is also conveyed to the rotational movement of the second clutch 115 which is therefore also prevented from further rotation
(77) Some preferred embodiments have been shown in the foregoing, but it should be stressed that the invention is not limited to these, but may be embodied in other ways within the subject matter defined in the following claims. It is especially stressed that the described hypocycloid geared EoC mechanism can by following the above be adjusted to accommodate any size of dosing from any initial content of liquid drug. It is further stressed that the disclosed positions of the EoC mechanism in the described embodiments could be different. The EoC mechanism could e.g. be provided in a different injection device and e.g. in a different position in the injection device.