TRAINING DEVICE

Abstract

A training device (10) for training a user in the operation of an auto-injector that dispenses a medicament is described. The training device (10) comprises a housing (13), an actuation assembly (22) located within the housing (13), the actuation assembly (22) comprising a plunger (24) and a guide member (26), the plunger and the guide member defining, and connected by, a complementary first male profile and a first female profile. The plunger (24) is movable with respect to the guide member (26) along a first path defined by at least a portion of the first male or the first female profiles, the plunger (24) moving linearly between a start position and a finish position. The first path extends in a direction non-parallel to the linear movement of the plunger (24).

Claims

1. A training device for training a user in the operation of an auto-injector that dispenses a medicament, the training device comprising: a housing; and an actuation assembly located within the housing, the actuation assembly comprising a plunger and a guide member, the plunger and the guide member defining, and connected by, a complementary first male profile and a first female profile, the plunger being movable with respect to the guide member along a first path defined by at least a portion of the first male or the first female profiles, the plunger moving linearly between a start position and a finish position, wherein the first path extends in a direction non-parallel to the linear movement of the plunger; wherein the actuation assembly further comprises a rotary damper, and wherein the training device comprises a locking mechanism configured to prevent further operation of the device until the device is unlocked.

2. (canceled)

3. (canceled)

4. The training device of claim 1, wherein the guide member defines a throughbore, the plunger passing through the throughbore.

5. The training device of claim 1 wherein the plunger defines a bore, the guide member being connected to an internal surface of the plunger.

6. The training device of claim 1, wherein the first path encircles a plunger longitudinal axis and is helical.

7. (canceled)

8. (canceled)

9. The training device of claim 1, wherein the first path is serpentine.

10. (canceled)

11. (canceled)

12. The training device of claim 1, wherein there are two paths, the first path and a second path, that define a double helix.

13. The training device of claim 1, wherein the actuation assembly further comprises a biasing mechanism.

14. The training device of claim 13, wherein the biasing mechanism is an energy accumulating member.

15. (canceled)

16. The training device of claim 1, wherein the actuation assembly further comprises a support member configured to support the plunger as it moves between the start position and the finish position.

17. The training device of claim 16, wherein the support member is different from the guide member.

18. (canceled)

19. (canceled)

20. (canceled)

21. The training device of claim 16, wherein the support member is axially fixed with respect to the plunger.

22. The training device of claim 16, wherein the support member is rotationally connected to the plunger.

23. The training device of claim 2, wherein the support member is rotationally connected to the plunger by a key and key way relationship.

24. (canceled)

25. (canceled)

26. The training device of claim 16, wherein the support member is connected to the rotary damper such that rotation of the support member is damped by the rotary damper.

27. The training device of claim 1, wherein the training device comprises a removable cap, the cap cooperating with the housing to provide a sealed unit; wherein removal of the cap reveals an open end defined by a cover sleeve, the cover sleeve configured to be the point of engagement with an injection site; and wherein the cover sleeve is movable with respect to the housing.

28. (canceled)

29. (canceled)

30. The training device of claim 1, wherein the training device comprises a trigger mechanism to trigger the actuation mechanism to start the movement of the plunger from the start position.

31. The training device of claim 30, wherein the trigger mechanism triggers the actuation mechanism upon a user pressing the training device against a surface.

32. (canceled)

33. (canceled)

34. The training device of claim 1, wherein the training device comprises a release mechanism configured to unlock the locking device and reset the training device.

35. (canceled)

36. The training device of claim 34, wherein the release mechanism is configured to engage the guide member with the locking mechanism, engagement of the guide member with the locking mechanism releasing the locking mechanism.

37. The training device of claim 1, wherein the training device comprises a removable cap, the cap cooperating with the housing to provide a sealed unit; wherein the training device comprises a release mechanism configured to unlock the locking mechanism and reset the timing device; and wherein the release mechanism is part of the removable cap.

38. The training device of claim 1, wherein the training device comprises a removable cap, the cap cooperating with the housing to provide a sealed unit; wherein the training device comprises a release mechanism configured to unlock the locking mechanism and reset the training device; and wherein replacement of the removable cap releases the locking mechanism.

39. The training device of claim 1, wherein the training device includes at least one sensor adapted to provide feedback to user on the successful operation of the device.

40. (canceled)

41. An actuation assembly comprising a plunger and a guide member, the plunger and the guide member defining, and connected by, a complementary first male profile and a first female profile, the plunger being movable with respect to the guide member along a first path defined by at least a portion of the first male or the first female profiles, the plunger moving linearly between a start position and a finish position, wherein the first path extends in a direction non-parallel to the linear movement of the plunger; wherein the actuation assembly comprises a rotary damper, and wherein the actuation assembly comprises a locking mechanism configured to prevent further operation of the assembly until the device is unlocked.

42. (canceled)

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0086] An embodiment of the present invention will now be described with reference to the accompanying drawings in which:

[0087] FIG. 1 is a perspective view of a training device, for training a user in the operation of an autoinjector that dispenses a medicament;

[0088] FIG. 2 is a partially exploded view of the training device of FIG. 1;

[0089] FIG. 3 is an exploded view of the housing assembly of the training device of FIG. 1;

[0090] FIG. 4 is an assembled view of the actuation assembly of the training device of FIG. 1;

[0091] FIG. 5 is an exploded view of the actuation assembly of the training device of FIG. 1;

[0092] FIG. 6 is a perspective view of part of the actuation assembly of the training device of FIG. 1 in a start position;

[0093] FIG. 7 shows a perspective view of part of the actuation assembly of the training device of FIG. 1 in a finish position;

[0094] FIG. 8 is a perspective view of the bracket and the guide member of the training device of FIG. 1;

[0095] FIG. 9 is a partially exploded perspective view of part of the training device of FIG. 1 showing part of the locking mechanism;

[0096] FIG. 10 is a section view through part of the training device of FIG. 1 showing the locking mechanism;

[0097] FIG. 11 is a perspective view of the locking mechanism body of the training device of FIG. 1 in a first orientation;

[0098] FIG. 12 is a perspective view of the locking mechanism body of the training device of FIG. 1 rotated 35 from the first orientation;

[0099] FIG. 13 is a perspective view of part of the training device of FIG. 1 showing the reset procedure;

[0100] FIG. 14 is a an exploded view of the housing assembly of another training device;

[0101] FIG. 15 is an exploded view of the actuation assembly of the training device of FIG. 14;

[0102] FIG. 16 is a perspective view of the actuation assembly of the training device of FIG. 14;

[0103] FIG. 17 is an exploded view of the locking mechanism of the training device of FIG. 14;

[0104] FIG. 18 is a perspective view of the locking mechanism of the training device of FIG. 14;

[0105] FIG. 19 is a perspective view of the locking mechanism of the training device of FIG. 14;

[0106] FIG. 20 is a perspective view of the locking mechanism of the training device of FIG. 14;

[0107] FIG. 21 is a perspective view of the locking mechanism of the training device of FIG. 14;

[0108] FIG. 22 is a perspective view of the locking mechanism of the training device of FIG. 14; and

[0109] FIG. 22A is a magnified perspective cross section view of part of the locking mechanism of the training device of FIG. 14;

DETAILED DESCRIPTION OF THE DRAWINGS

[0110] Reference is first made to FIG. 1, a perspective view of a training device, generally indicated by reference numeral 10, for training a user in the operation of an autoinjector that dispenses a medicament, and FIG. 2 a partially exploded view of the training device 10 of FIG. 1.

[0111] The training device 10 comprises a housing assembly 12 and an end cap 14. As can be seen from FIG. 2, the end cap 14 can be removed. The end cap 14 includes a setting tool 16, the purpose of which will be discussed in due course. In a storage configuration shown in FIG. 1, the setting tool 16 is inserted inside a housing body 13 as indicated by the arrow.

[0112] Referring now to FIG. 3, an exploded view of the housing assembly 12 of the training device 10, the housing assembly 12 comprises an initiator 18, a bracket 20, an actuation assembly 22 and a locking mechanism 74.

[0113] The actuation assembly 22 comprises a plunger mechanism 24 and a guide member 26, which will now be discussed in more detail with reference to FIG. 4, an assembled view of the actuation assembly 22 and FIG. 5, an exploded view of the actuation assembly 22 of the training device 10.

[0114] The plunger mechanism 24 comprises a plunger 30 defining a helical profile 32, a support member 34, a biasing member 36 in the form of a compression spring 38, a rotary damper 40, a retaining clip 42 and an end cap 44.

[0115] The helical profile 32 is a double helix, that is, the profile 32 comprises a first helical path 46 and a second helical path 48, the two helical paths 46, 48 being entwined.

[0116] Both helical paths 46, 48 have a start 50 (only the start 50a of the first helical path 46 is visible on FIG. 4) and a finish 52 (only the finish 52b of the second helical path 48 is visible on FIG. 4).

[0117] The guide member 26 has an internal helical profile 54 which is complimentary to the first helical path 46 and the second helical path 48 defined by the plunger 30.

[0118] The support member 34 is attached to the rotary damper 40 such that rotation of the support member 34 is damped by the rotary damper 40. The support member 34 is, in turn, telescopically connected to the plunger 30. Furthermore the support member 34 and the plunger 30 are connected by a key and keyway (not shown) relationship, the keyway extending axially along the support member 34. This arrangement permits respective telescopic movement between the support member 34 and the plunger 30, but insurers rotation of one of the plunger 30 and the support member 34 is transmitted to the other of the plunger 30 and support member 34.

[0119] The plunger 30 is movable between a start position and a finish position as will be discussed shortly in connection with FIGS. 6 and 7. However, the start position is shown in FIG. 4, and in this position the plunger 30 is retained from moving telescopically with respect to the support member 34 by the retaining clip 42. The retaining clip 42 is engaged with a flange 58 defined by the plunger 30 (FIG. 5). When the retaining clip 42 is opened (as will be discussed in due course) the flange 58 is released from the clip 42, and the plunger 30 can move under the action of the compression spring 38 which is compressed in the start position.

[0120] Referring back to FIG. 1, the housing body 13 defines a number of windows 60. These windows 60 allow a view of the interior of the training device 10 and during operation, the plunger 30 moves axially down the housing body 13 past the windows 60 providing a visual indication to the user that the training device 10 is operating correctly and reinforcing the learning of the auto injection method of treatment.

[0121] As was described in the background to the invention, one of the challenges of simulating an actual autoinjector is replicating the stroke of the plunger which, in an actual autoinjector is resisted by the liquid medicament being dispensed. This problem is solved in this embodiment of the invention by the combination of the guide member 26 and the rotary damper 40 as will now be described with reference to FIGS. 6 and 7.

[0122] FIG. 6 shows a perspective view of part of the actuation assembly 22 of the training device 10 in a start position and FIG. 7 shows a perspective view of part of the actuation assembly 22 of the training device 10 in a finish position.

[0123] In use, the guide member 26 and the rotary damper 40 are substantially fixed both axially and rotationally with respect to the housing body 13 (not shown). Once the plunger 30 is released by the retaining clip 42 (not shown), the plunger 30 will be urged to move towards the finish position due to the force applied by the compression spring 38 (not shown). As the guide member 26 is substantially fixed rotationally, for the plunger 30 to pass through the guide member 26, the plunger 30 will have to rotate due to the engagement between the helical profile 32 of the plunger 30 and the helical profile 56 (not shown) of the guide member 26. As the plunger 30 moves linearly along a plunger mechanism longitudinal axis 62 between the start position of FIG. 6 and the finish position of FIG. 7, it also takes a rotational path defined by the plunger helical profile 32. As this helical path is non-linear, it increases the length of time the plunger 30 takes to move between the start and finish position (compared to the length of time the plunger 30 would have taken if it had just taken a linear path). Therefore the selection of a particular helical profile 32, or indeed any profile which adds component of movement at an angle to the linear direction of travel, can be used to control and contribute to the speed at which the plunger 30 travels between the start and finish positions.

[0124] It will be noted that the start 50 and finish 52 of the helical paths 46, 48 are linear. In use, as the plunger 30 moves from linear to helical travel at the end of the helical path start 50, the engagement between the guide member 26 and the plunger 30 creates an audible click. This replicates the clicking sound of an actual autoinjector when the injection process starts. Similarly as the plunger 30 moves from helical to linear travel at the beginning of the helical path finish 52, a further click is heard, replicating the clicking sound of an actual autoinjector when the injection process finishes.

[0125] As the plunger 30 moves from the start position to the finish position, the rotation of the plunger 30 is transmitted to the support member 36 by the key on the plunger 30 engaging with the keyway on the support member 36. This causes rotation of the support member 36. However this rotation is resisted by the rotary damper 40 which rotate in a plane perpendicular to the longitudinal axis 62. This arrangement further dampens the movement of the plunger providing additional force which the helical spring 38 has to overcome to move the plunger 30 along the axis 62 between the start and finish positions.

[0126] Referring to FIG. 8, a perspective view of the bracket 20 and the guide member 26, the bracket 20 defines a cage 64 in which the guide member 26 sits, the guide member 26 being retained in the cage by a cage lip 72. The cage 64 is sized to allow a small amount of axial movement of the guide member 26, as will be described in due course. The guide member 26 defines a lower serrated edge 66 and an upper serrated edge 68. The serrated edges prevent rotation of the guide member by engagement with a complementary serrated edge on another component.

[0127] The bracket cage 64 defines one of the complementary serrated edge 70 which engages the lower serrated edge 66, the action of the plunger 30 pushing the guide member 26 against the complimentary serrated edge 70. The engagement of the serrated edges 66, 70 preventing rotational movement of the guide member 26.

[0128] The training device further comprises a locking mechanism 74 which is shown in FIG. 9, a partially exploded perspective view of part of the training device 10 of FIG. 1 showing part of the locking mechanism 74, and FIG. 10 a section view through part of the training device 10 of FIG. 1 showing the locking mechanism 74. The purpose of the locking mechanism is to lock the initiator 18 in the finish position, at least until training device 10 is reset. This is to simulate the real autoinjector which may be for single use. Similarly, in an autoinjector intended for repeated use an interim step is required (e.g. removing the empty medicament container and placing a new one). By locking the training device 10 an interim step of resetting the training device 10 is required making the user experience much more realistic.

[0129] The locking mechanism 74 comprises a locking mechanism body 76, a spring 78 and a locking mechanism housing in the form of a collar 80. The spring 78 is located in a recess between a locking mechanism body lip 82 and a collar lip 84, biasing the body 76 and the collar 84 apart.

[0130] Also visible on FIG. 9 is the initiator 18. This is the part of the training device 10 which engages the user at the site which medicament is to be injected into. The initiator 18 defines a user engaging surface 86 for this purpose. When a user presses the training device 10 against the skin, the rest of the training device 10 moves towards the use of skin with respect to the initiator 18 which remains stationary. The initiator 18 includes fingers 87 which press against a locking mechanism body surface 88. As the user continues to press the training device 10, further axial movement of the locking mechanism body 76 is prevented and the spring 78 is compressed. Continued application of pressure by the user moves the plunger retaining clip 42 towards a locking mechanism body end 90. Once the retaining clip 42 engages with the locking mechanism body end 90, the retaining clip 42 is forced open releasing the plunger flange 58, thereby allowing the plunger to move from the start position to the finish position.

[0131] FIG. 11 is a perspective view of the locking mechanism body 76 in a first orientation and FIG. 12 is a perspective view of the locking mechanism body 76 rotated 90 from the first orientation. It can be seen from FIG. 11 that the locking mechanism body defines a rotation track 92. There is another identical rotation track on the opposite side of the locking mechanism body 76.

[0132] The locking mechanism body 76 further defines a locking track 94. Again there is an identical locking track on the opposite side of the locking mechanism body 76.

[0133] The locking mechanism collar 80 (not shown) defines four blocks 96 which extend from an internal surface of the collar 80 into each of the tracks 92, 94. Two of the blocks 96 are shown, a rotation track block 96R and a locking track block 96L.

[0134] When the initiator fingers 87 engage the locking mechanism body surface 88, and the locking mechanism is moved axially towards the retaining clip 42, the blocks 96 travel from point A to point B in their respective tracks 92, 94.

[0135] At point B, the rotation blocks 96R engage an angled track surface 98 which causes the locking mechanism body 76 to rotate as the collar 80 is additionally fixed to the training device housing body 13. At point C, the locking mechanism body has reached the extent of its travel and the locking mechanism body end 90 has released the plunger flange 58 from the retaining clips 42. It will be noted that the locking track 94 includes a step 100 which the locking track block 96L goes down in moving from point B to point C.

[0136] Upon release of the pressure by the user, the spring 78 will push the locking mechanism body 76 away from the locking mechanism collar 80 and the blocks 96 move from point C to point D in their respective tracks 92, 94.

[0137] As shown in FIG. 12, the locking track 94 includes a locking arm 102 which deflects open as the locking track block 96L moves from point C to point D. This locking arm 102 prevents movement back from point D to point C due to a locking arm protrusion 104. Furthermore, the step 100 prevents the locking track block 96L from moving from point D to point A.

[0138] In this position the device 10 is locked and will remain unusable until the locking mechanism 28 is released.

[0139] Reference is now made to FIG. 13, a perspective view of part of the device 10 of FIG. 1 showing the reset procedure. To reset the device 10, the setting tool 16 (FIG. 2) is pushed into the end 106 of the plunger 30. This creates sufficient axial movement of the plunger 30 and the guide member 26 to release the guide member lower serrated edge 66 from the bracket serrated edge 70 and towards the locking mechanism surface 88. The guide member 26 does not leave the bracket cage 64, it just moves slightly axially within the cage 64.

[0140] The guide member upper serrated surface 68 then engages a serrated surface 108 defined by the locking mechanism surface 88. The guide member 26 is then rotationally locked and the application of pressure to the plunger creates a rotational force on the guide member sufficient to allow the locking track block 96L to overcome the step 100 and move to the start position point A.

[0141] Further application of pressure to the plunger 30 resets the plunger 30 with the plunger flange being pressed into the retaining clip 42. In this position the end cap 14 is back in the position shown in FIG. 1 and the training device 10 is ready for another use.

[0142] FIGS. 14 to 22 and 22A show a training device 10 of similar form to that of FIGS. 1 to 13 but with an alternative locking mechanism arrangement.

[0143] In FIG. 14 an exploded view similar to that of FIG. 3 is shown with like parts numbered the same. The plunger mechanism 24 has generally the same structure as that shown in FIGS. 4 to 7. The guide member 26 of the actuation assembly 22, and the locking mechanism 28, each take a different form as discussed below. When assembled the training device has the same appearance as the embodiment depicted in FIGS. 1 and 2.

[0144] As shown in more detail in FIGS. 15 and 16 the guide member 26 has an internal helical profile 54 that allows it to fit about and engage with the first and second helical paths 46 and 48 on the plunger 30 in the same way as the apparatus of FIGS. 1 to 13.

[0145] FIG. 17 shows guide member 26 in relation to an exploded view of locking mechanism 74 (FIG. 15). The locking mechanism 74 comprises a locking mechanism body 76, a spring 78 and a locking mechanism housing in the form of a collar 80. The spring 78 is located in a recess between a locking mechanism body lip 82 and a collar lip 84, biasing the body 76 and the collar 80 apart. When assembled the locking mechanism body 76 and housing (collar 80) are in a telescopic relationship. The locking mechanism body (typically of a plastics material) includes a body end 90 and two resilient projections (clips) 110 which, unless pressed radially inwards, will not pass the end 112 of collar 80 that receives body 76 as it is pushed into it. In this example a metal reinforcing member 114 fits inside projections 110 to provide additional consistency to their action. Guide member 26 includes a distal end 116, and a proximal end 118 including slots 120 in the body of the guide member, in bulges 122 in this example. The slots 120 are for engaging with the locking mechanism body 76. The guide member 26 can slide through the locking mechanism body lip 82 so that slots 120 in bulges 122 can accept projections 110 and drive them radially inwards, sufficient to allow the projections to pass into collar 80.

[0146] FIG. 18 shows a partial view of the assembled device including locking mechanism 74 and other internals. Spring 78 (FIG. 17) is not shown for clarity. In FIG. 18 guide member 26 is nested inside locking mechanism body 76 so that projections 110 are accepted into the slots 120 in bulges 122 (neither slots 120 or projections 110 are visible in this view). Guide member 26 is supported by bracket 20 at distal end 116. The guide member is captive but able to have limited linear motion as suggested by arrows L. Guide member 26 is not free to rotate, prevented by ribs 124 which slide in grooves in the bracket. In the position shown the fingers 87 of initiator 18 are contacting lip 82 of the locking mechanism body 76. As a user simulates making an injection by pressing the end of the initiator against their body, the locking mechanism body 76 will move in the direction of arrow A against the resistance of spring 78 (FIG. 17).

[0147] FIG. 19 shows a similar view to that of FIG. 18 but with the locking mechanism body 76 further advanced in direction A by the action of initiator fingers 87. The locking mechanism collar 80 is transparent in this view to allow viewing inside. In this position projections 110 are sliding inside collar 80 and locking mechanism body end 90 is approaching trigger retaining clip 42 where it will cause release of the plunger 30 to travel in direction B.

[0148] FIG. 20 shows the situation following release of plunger 30. Movement of plunger 30 in direction B has caused guide member 26 to move in the same direction by the amount allowed by bracket 20 (suggested by arrow L1), This creates a gap 124 between the proximal end 118 of the guide member and the proximal end 112 of the collar 80.

[0149] In FIG. 21 the locking mechanism body 76 has returned to the position with respect to collar 80 it had in FIG. 18, but guide member 26 remains at a spacing of gap 124. This allows the projections 110 to escape radially outwards into gap 124, locking the locking mechanism to the position shown in FIG. 22.

[0150] As shown in FIG. 22 the projections 110 on locking mechanism body 76 prevent travel in direction A, when the body 76 is pushed by initiator fingers 87. The projections 110 but against the proximal end 112 of collar 80. To release the lock, plunger 30 is moved by insertion of setting tool 16 into the device (FIG. 2). This pushes plunger 30 in direction A, in turn moving guide member 26 by the distance L2 (see FIG. 22A, discussed below). Movement L2 allows the slots 120 in bulges 122 of guide member 26 to accept the projections 110 on locking mechanism body 76, deflecting them radially inwards. Thus, the device is returned to the unlocked start position of FIG. 18, where projections 110 can pass into the collar 80.

[0151] FIG. 22A shows in magnified detail the interaction between the plunger 30 and the guide member 26 in the bracket 20 after the unlocking procedure described above with respect to FIG. 22 has been made. As plunger 30 was moved in the direction A, close to its start position, a projection 126 on the plunger engaged a corresponding projection 128 on the guide member 26, near to its distal end 116. This caused the linear motion L2 indicated by arrow on FIG. 22. The resulting position shown in FIG. 22A has the distal end 116 of guide member 26 abutting the end 130 of bracket 20 i.e. the captive guide member 26 has been moved to the start position shown in FIG. 18.