INJECTION DEVICE WITH SAFE TRIGGER FUNCTION
20210338937 · 2021-11-04
Inventors
- Callum Davies (Woodstock, GB)
- Abiodun Falodi (Woodstock, GB)
- Matthew Farmer (Woodstock, GB)
- Oliver Gould (Woodstock, GB)
- Oliver Hyde (Woodstock, GB)
- Parshia Moghadas (Woodstock, GB)
- Timothy Muller (Woodstock, GB)
- Tahir Shabudin (Woodstock, GB)
Cpc classification
A61M5/326
HUMAN NECESSITIES
A61M5/2033
HUMAN NECESSITIES
A61M5/3202
HUMAN NECESSITIES
A61M5/31513
HUMAN NECESSITIES
A61M2005/31521
HUMAN NECESSITIES
A61M5/24
HUMAN NECESSITIES
A61M2207/00
HUMAN NECESSITIES
A61M2005/2073
HUMAN NECESSITIES
International classification
A61M5/315
HUMAN NECESSITIES
A61M5/20
HUMAN NECESSITIES
Abstract
An injection device is disclosed comprising a plunger for expressing medicament from a syringe and a delivery mechanism arranged in use to provide a forward biasing force to urge the plunger from a first rearward position to a second forward position to express a dose from the syringe. A latch arrangement is provided that releasably holds the plunger against the force of the de livery mechanism. The latch arrangement comprising at least two resilient segments which define opposing sections of an aperture within which a rearward end of the plunger is retained in the rearward position. A trigger is provided for releasing the plunger in use, the trigger being arranged to outwardly deflect at least one of the resilient segments such that the aperture is expanded to release the rearward end of the plunger. A method of manufacturing the injection device is also enclosed.
Claims
1-28. (canceled)
29. A method of modular manufacture of an injector device comprising: providing a common forward body assembly; providing a common delivery mechanism assembly; and providing two alternate rear body assembly types, wherein a first rearward assembly type is provided with a trigger moveable relative to a rear housing, and a second rearward assembly type is provided with a trigger fixed relative to a rear body housing.
30. A method as claimed in claim 29, wherein both types of rearward assemblies are arranged to be slidably connected to the common forward body assembly.
31. A method as claimed in claim 30, wherein the second rearward assembly type is formed by providing a trigger member which is fixed relative to the rear housing.
32. A method as claimed in claim 29, wherein the trigger is engaged with the first rearward assembly or the second rearward assembly by a snap fit arrangement.
33. A method as claimed in claim 31, wherein the first rearward assembly type is formed by movably attaching a trigger member to the rearward housing.
34. A method as claimed in claim 29, wherein the common delivery mechanism includes a latch, which is fixed relative to the common forward body assembly.
35. A modular manufacturing system for injection devices having different modes of actuation, the injection devices comprising: a forward assembly; a delivery mechanism; and a rearward assembly, the rearward assembly being provided with two alternate arrangements: a first rearward assembly providing a button activated injection device, the first rearward assembly including a trigger button moveably mounted on a rear housing for activating the delivery mechanism in use; and a second rearward assembly providing a pressure activated injection device, the second rearward assembly including a trigger for activating the delivery mechanism, the trigger being fixed relative to the rear housing and the rear housing being slidably attached to the forward assembly.
36. The manufacturing system of claim 35, wherein in the first rearward assembly, the rear housing is slidably attached to the forward assembly.
37. The manufacturing system of claim 36, wherein the second rearward assembly is provided with a fixed closure element in place of the trigger button.
38. The manufacturing system of claim 37, wherein the fixed closure element includes a trigger feature.
39. The manufacturing system of claim 38, wherein the delivery mechanism is fixed relative to the forward assembly.
40. The manufacturing system of claim 39, wherein in an initial pre-use assembled arrangement the rearward assembly engages a latch mechanism of the delivery mechanism.
41. The manufacturing system of claim 40, wherein the forward assembly includes a syringe carrier for receiving a syringe of medicament.
42-43. (canceled)
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0042] The invention may be performed in various ways and an embodiment thereof, with various modifications, will now be described by way of example only, reference being made to the accompanying drawings in which:
[0043]
[0044]
[0045]
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[0050]
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[0053]
DETAILED DESCRIPTION OF EMBODIMENTS
[0054] Front as used herein will be understood to refer to the end of the injector assembly (or components thereof) which, in use, are closest to the delivery needle delivery end of the injector (i.e. the end which is pointed at the skin). Rear as used herein will be understood to refer to the end of the pen injector assembly (or components thereof) which, in use, are furthest from the needle delivery end of the injector (i.e. the end which is pointed away from the skin). Forward and rearward will, likewise, be understood to refer to the directions orientated towards the front and rear of the injector assembly.
[0055] Axial, radial and circumferential are used herein to conveniently refer to the general directions relative to the longitudinal direction of the injection device (or components thereof). The skilled person will, however, appreciated that these terms are intended to be broadly interpreted (and for example, the injection device may have a non-circular and/or irregular form). Typically, regardless of the chosen injector device external profile the cartridge or syringe will have a conventional generally cylindrical form and, as such, the longitudinal axis of the injection device will substantially coincide with (or be parallel to) the axial direction of the syringe.
[0056] As seen in
[0057] The syringe 5 is a conventional syringe having a bung or stopper 7 within its body and a needle at its forward end which may initially be protected (so as to remain sterile) by a removable needle shield 6. The illustrated autoinjector 1 is generally intended to be a single use device (although the skilled person will appreciate that the invention is not limited to such devices) and, therefore, the exploded view of
[0058] An exploded view of each of the forward assembly is shown in
[0059] The forward assembly 2 comprises the forward body 20 which is adapted to receive a cap 10 which closes the forward end of the autoinjector 1. Within the assembly 2 there is a syringe carrier 55 for movably mounting the syringe within the forward body 20 to enable automatic needle penetration.
[0060] A needle shroud 50 is also provided and arranged to shroud the needle after use (when the syringe 5 and syringe carrier 55 are in a forward position) to prevent needle stick injuries. The shroud 50 is activated by a pair of side-by-side shroud springs 51a, 51b carried on a spring guide 52. The syringe carrier 55 and/or needle shroud 50 are not essential to the present invention and, as such, the operation of the shroud 50 and carrier 55 is not described in detail. However, it may be noted that the arrangement is generally of the type described in the applicants' earlier International Patent Application
[0061] The rear assembly 3 includes a trigger button 70 which is inserted into the rearward housing 30 from the rearward end so as to substantially close the rearward end of the injector housing. The trigger button 70 has a cup-like profile with side walls which are arranged to fit within (and be substantially concentric with) the rearward housing 30 and an end wall which closes the rear end of the housing. The trigger button 70 may conveniently comprise a single moulded part. However, for ease of manufacture and or assembly, in the embodiment of
[0062] The drive mechanism 40 is positioned between the front assembly 2 and rear assembly 3. The drive mechanism 40 includes a plunger 42 which is arranged to engage the bung of the syringe in use. The plunger 42 is driven forwards in use by a pair of concentric drive springs 44a and 44b (although it will be appreciated that in other embodiments a single spring may be used) with an intermediate drive member 43 provided therebetween. A latch 60 is arranged concentrically around the drive springs 44, intermediate member 43 and plunger 42. The latch 60 is arranged to hold the plunger 42 against the bias of the springs 44 until the latch is released via the trigger button 70 (when both drive springs and the intermediate drive member are all released together). The latch 60 comprises a rear body portion 60b having a split cylinder profile formed of four quadrants extending rearwardly from a forward connecting body portion 60a. As described in further detail below, each quadrant is resiliently deflectable in use from the initial position (shown in
[0063] The rearward assembly also includes an indicator arrangement 90 provided by an elongate sprung member which is attached to the plunger 42.
[0064] A housing biasing spring 61 is provided within the rearward assembly 3 and in the assembled arrangement is captive between the latch 60 and rearward housing 30. Thus, the biasing spring 61 urges the forward and rearward sub-assemblies 2, 3 towards an initial expanded state.
[0065] The connection between the sub-assemblies 2, 3 is provided via the latch 60 which it acts as an intermediate connecting member. The interconnection is a resilient snap fit connection which provides for ease of manufacture particularly for a single-use device (which the user will not be required to disassemble). Thus, it may be noted that the forward portion 60a of the latch 60 has been inserted into the rearward end of the forward housing 20. The forward housing 20 and latch 60 are provided with cooperating engagement features 25, 65 to provide an automatic connection when brought together. In the illustrated embodiment, the engagement features comprise a cut-out 25 in the forward housing 20 and an outward projection 65 in the forward portion 60a of the latch 60. It may be noted that in the illustrated embodiment the rearward housing 30 extends over the cut out 25, thereby covering the opening in the housing and preventing the user from disengaging the projection 65 to force separation of the housing body portions 20 and 30.
[0066] When assembled, the latch 60 is axially slidably connected to the rearward housing 30 via the trigger button 70. The rearward housing 30 includes a radial flange 32 which extends from the interior bore of the rearward housing 30. It will be noted that the radial flange 32 is spaced radially apart from the inner surface of the rearward housing wall along part of its circumference as shown in
[0067] Thus, it will be noted that an axially extending (and at least partially annular) space is defined between interior of the forwardly extending arms 73 of the trigger button 70 and the exterior of the rearward portion 60b of the latch member 60. The radially spaced portion of the flange 32 is captive within the space S. Also captive within the space is the housing biasing spring 61. The housing biasing spring 61 may, thus, act between a forward face of the flange 32 and a rearward face of the latch 60.
[0068] The operation of the latch and trigger arrangement will now be described with reference to
[0069] In
[0070] In accordance with an embodiment of the invention the inner wall of the trigger button 70 is provided with two diametrically opposed pairs of axially aligned inwardly projecting ribs 76, 76′. Each pair of ribs 76, 76′ consists of a pair of transversely spaced apart projections 76a and 76b. The ribs 76, 76′ may have a tapered profile as they extend rearwardly (which it will be understood from the below description may provide a progressive engagement/action). In the initial, pre-use position of
[0071] The latch 60 is provided with corresponding features for engaging the ribs 76, 76′. In the illustrated embodiment, the corresponding features comprise outwardly extending projections 67 which are formed on an outer surface of each resilient quadrant of the rearward portion of the latch 60b. As such, one outward projection 67 is provided on each quadrant and corresponds to one of the corresponding two pairs of ribs on the trigger button 70. The projections 67 extend forwardly along the outer wall of the resilient quadrant of the latch 60b and inwardly inclined as they extend forwardly. Thus, the projections 67 provide a cam surface along which the forward end of the respective rib 76 will run during forward movement of the trigger button 70 relative to the latch 60.
[0072] The camming action of the ribs 76 and projections 67 is illustrated schematically in
[0073] It will of course be appreciated that whilst in the above embodiment ribs 76 are provided on the trigger 70 and angled projections 67 are provided on the latch, these features could be altered whilst still providing corresponding camming arrangements. For example, the features on the latch 60 could be straight and the features on the trigger could be angled. Further, one of the latch 60 and trigger 70 could be provided with a groove or recess into which a projection of the other is received (and in such an arrangement, a wall of the recess may provide a camming surface).
[0074] Whilst the embodiment of
[0075] The forward assembly 2 and delivery mechanism of this embodiment is identical to the previous button activated embodiment and, therefore, provides a convenient method and system of manufacture in which either device may be produced using common manufacturing lines. The closure element 170 is similar in shape and construction to the trigger button 70 of the previous embodiment (which advantageously allows the rear housing 30 to be substantially the same, or even identical, to the rear housing of the button activated embodiment).
[0076] The closure 170 is arranged to be received in the end of the rearward housing 30 in a similar manned to the button 70. However, the rearward end of the element 170 is provided with a flange 177 which abuts the rearward end face 32 of the rearward housing 30 to fix the closure in a forward direction relative to the housing. Forward of the flange, cooperating features 33 and 173 are provided on an outer surface of the closure 170 and the inner surface of the rearward housing 30. At least one of the cooperating features 173 and 33 are provided with a barbed profile, to provide a snap fit arrangement, such that the closure 170 can be inserted forwardly into the housing 30 but is then fixed against rearward relative. Thus, once assembled the closure 170 is fixed in both a forward and rearward axial direction relative to the rearward housing 30.
[0077] As seen best in the cross section of
[0078] It will be noted that the rearward portion of closure 170 provides the trigger arrangement in the form of axially extending ribs 176a and 176b (and a diametrically opposing pair of ribs). It will be appreciated that these ribs 176 are arranged to activate the device in exactly the same manner as those of the button 70.
[0079] For completeness, it may be noted that the distinction between the operation of the two embodiments is as follows. In the first embodiment, the rearward housing 30 initially slides forwardly (in response to the user holding the rear housing and pressing the front of the device against an injection site) with the trigger button 70 remaining fixed relative to the latch 60. The relative movement of the housing 30 moves an interlock arrangement out of alignment. This movement acts to reveal the button 70 at the rear of the rearward housing 30, then allows the button 70 to be urged forwardly to release the latch 60. In the second embodiment, the rearward housing 30 and closure 170 are urged forwardly together until the trigger features 176 come into engagement with the latch 60.
[0080] The skilled person will appreciate that when designing a device according to an embodiment of the invention the point of release of the latch 60 may be readily adjusted to provide the desired sequencing by adjusting the shape, profile and relative position of the camming surfaces 76/176 and 67 provided on the latch 60 and trigger 70. Further, the arrangement of embodiments of the invention may provide more precise control of the latch release than devices which rely upon either the forward biasing of the delivery mechanism on the plunger or contact with the plunger to release the latch. For example, the arrangement of the invention may be useful in ensuring that issues such as plastic creep do not prevent successful release of the plunger 42 from the latch 60 if the injector device has been stored for an extended period before use.
[0081] A further advantage of the arrangement of the invention is that by providing the engagement between the latch 60 and the trigger 76/176 at an outer surface of the latch 60 further clearance may be provided within the rear portion of the button 70 or closure 170 to improve operation of the indication arrangement 90.
[0082] A further button activated embodiment of the invention is shown in sequential operation in
[0083] The overall operation principle of the embodiment of
[0084] In the embodiment of
[0085] During use, a user offers the device up to an injection site and urges the device into firm contact whilst gripping an outer surface of the rearward body housing 230. This causes the rearward housing to slide forward relative to the latch 260 (and associated forward housing) in the direction of arrow C. This, movement compresses the spring 261 and moves the device into the configuration of
[0086] The user is subsequently able to urge the trigger button 270 forward in the direction of arrow D as shown in
[0087] If the trigger and interlock are not activated in the correct sequence, for example due to a user attempting to press the trigger button 270 without having first pressed the device firmly against an injection site or if the device is dropped, the ribs 276 of the trigger 270 will force the projections against the ribs 234 of the blocking arrangement of the rearward housing 230. Thus, the system will effectively “bind” together and lock the latch 260 against accidental or premature release.
[0088] The plunger arrangement of the device of
[0089] The plunger arrangement of this embodiment also includes additional features to further reduce the risk of unintended or premature release of the head 42a from the aperture 266 of the latch 260 (and resulting accidental firing of the autoinjection device).
[0090] Firstly, the forward facing surface of the head 42a is provided with an asymmetric profile. More specifically, the forward facing surface is formed by a first segment 86 having a forward face which is angled forwardly at a first angle and a second segment 84 which is inclined at a shallower angle. The first 84 and second 86 segments may be on opposing radial sides of the plunger 42 and may engage different segments of the latch 260. The second segment 84 may be substantially radially aligned and extend substantially perpendicularly to the longitudinal axis of the plunger 42. The asymmetric profile of the forward face ensures that the surfaces cannot act together to urge the segments of the latch 260 radially apart (particularly once the rear body housing 130 has been moved forward to unlock the interlock so is no longer preventing movement of the latch 60). Thus, the arrangement of the head ensures that the plunger head 42a can only be released from the aperture 266 of the latch 260 by the trigger button 270 forcing the flexure of the segments of the latch 260 (even after the interlock has been disengaged).
[0091] The applicants have for example found that the facing surfaces of the interface could be angled between 0 and 45% facing angle. For example a 30 degree angle may be used (with the asymmetric face shape having at least one section with a different angle).
[0092] Advantageously, the shallow angle interface between the latch 260 and second segment 84 provides an increased friction engagement between the plunger head 42a and the latch 260. In contrast to an arrangement, such as that of the preceding embodiment, having a uniform tapered transition surface extending from the reduced diameter neck 80 to the head 42a, the interaction between the surface 84 of the head 42a and latch 260 urge the latch towards its closed position rather than act to splay the latch open. The asymmetric profile also provides a more reliable latching between the plunger 42 and latch 260 since the head 42a is retained on a known side of the latch.
[0093] In order to assist with reliably firing of the device the button 270 may be provided with an alignment member in the form of a central projection 277 on a forward facing surface which is arranged to ensure that the plunger 42 retains the correct alignment (i.e. centred) during firing. In particular, the projection 277 is positioned such that it is on the same side of the rearward most part of the plunger head 42a as the shallow angled segment 84. Thus, the projection 277 ensures that there is no risk of the plunger 42 remaining hung on the higher friction engagement segment.
[0094] Further, the aperture 66 and neck 80 of the plunger 42 are provided with complimentary non-rotational features which act to prevent relative rotation between the latch 260 and the plunger 42. The neck of the plunger 80 may be provided with a keyed profile which matches a corresponding profile of the aperture 266. For example, as shown in
[0095] Although the invention has been described above with reference to preferred embodiments, it will be appreciated that various changes or modifications may be made without departing from the scope of the invention as defined in the appended claims.
[0096] For example, in either embodiment of the invention, the button 70, rear housing 30 or closure 170 may also be provided with features which block outward movement of the resilient portion 60b of the latch in an initial position. Thus, premature or accidental release of the delivery mechanism may be prevented and correct sequencing further ensured.