Medicament delivery devices
11305061 · 2022-04-19
Assignee
Inventors
- James Grimoldby (Oxfordshire, GB)
- Oliver Gareth Hyde (Oxfordshire, GB)
- Matthew Watts (Oxfordshire, GB)
- Lee Pearson (Oxfordshire, GB)
Cpc classification
A61M5/3146
HUMAN NECESSITIES
A61M2005/208
HUMAN NECESSITIES
A61M5/3287
HUMAN NECESSITIES
A61M5/3156
HUMAN NECESSITIES
A61M5/3257
HUMAN NECESSITIES
A61M5/3157
HUMAN NECESSITIES
A61M5/2033
HUMAN NECESSITIES
A61M5/31585
HUMAN NECESSITIES
A61M2005/2073
HUMAN NECESSITIES
International classification
A61M5/20
HUMAN NECESSITIES
A61M5/315
HUMAN NECESSITIES
Abstract
A device for delivery of a medicament from a container (10) having an outlet (16) at a distal end of the container (10) and a stopper (22) for containing the medicament in the container (10). The device comprises a housing (110, 140), a drive element (300) arranged to move in the distal direction to cooperate with the container (10), a drive mechanism comprising a trigger component (200), the drive mechanism being arranged to hold the drive element (300) in a starting position and to move the drive element (300) in the distal direction from the starting position upon displacement of the trigger component (200) from a working position to a firing position, an interlock component (250) received in the housing (110, 140) and arranged for movement with respect to the housing (110, 140) from a first position to a second position, and at least one flexible locking member (214) arranged to cooperate with a stop face (160) associated with the housing (110, 140) to prevent displacement of the trigger component (200) to the firing position when the interlock component (250) is in the first position. Movement of the interlock component (250) towards the second position causes bending of the flexible locking member (214) away from the stop face (160) to allow displacement of the trigger component (200) to the firing position.
Claims
1. A device for delivery of a medicament from a container having an outlet at a distal end of the container and a stopper for containing the medicament in the container, the device comprising: a housing; a plunger arranged to move in a distal direction to cooperate with the container; a drive mechanism comprising a trigger button, the drive mechanism being arranged to hold the plunger in a starting position and to move the plunger in the distal direction from the starting position upon displacement of the trigger button from a working position to a firing position; an interlock component received in the housing and arranged for movement with respect to the housing from a first position to a second position; and at least one flexible locking member arranged to cooperate with a stop face associated with the housing to prevent displacement of the trigger button to the firing position when the interlock component is in the first position, wherein the at least one flexible locking member is located on the trigger button, wherein the interlock component is not in contact with the at least one flexible locking member in the first position, wherein the interlock component is arranged to contact the at least one flexible locking member upon movement of the interlock component towards the second position, and wherein movement of the interlock component towards the second position causes bending of the flexible locking member away from the stop face to allow displacement of the trigger button to the firing position.
2. The device according to claim 1, wherein the flexible locking member is arranged to abut the stop face when the interlock component is in the first position, and wherein bending of the flexible locking member upon movement of the interlock component towards the second position causes the flexible locking member to move clear of the stop face.
3. The device according to claim 1, wherein the stop face prevents distal movement of the flexible locking member when the interlock component is in the first position.
4. The device according to claim 1, wherein a proximal part of the interlock component contacts the flexible locking member upon movement of the interlock component towards the second position.
5. The device according to claim 1, wherein the flexible locking member is associated with the interlock component, and comprises a blocking face arranged to block distal movement of the trigger button when the flexible locking member cooperates with the stop face.
6. The device according to claim 1, comprising a guide formation arranged to cooperate with the flexible locking member to cause further bending of the flexible locking member upon movement of the trigger button to the firing position.
7. The device according to claim 6, wherein the guide formation is associated with the housing.
8. The device according to claim 1, wherein a firing mechanism comprises a latching arrangement for latching the plunger in the starting position, and wherein the trigger button comprises a latch release member for releasing the latching arrangement upon movement of the trigger button to the fired position.
9. The device according to claim 8, wherein the interlock component cooperates with the latching arrangement to block the release of the latching arrangement when the interlock component is in the first position.
10. The device according to claim 8, wherein the latching arrangement comprises at least one latching arm associated with the plunger, wherein the latching arm is arranged to engage with the housing to latch the plunger in the starting position and the latch release member is arranged to disengage the latching arm from the housing upon movement of the trigger button to the firing position, and wherein the interlock component cooperates with the latching arm to prevent disengagement of the latching arm from the housing when the interlock component is in its first position, and the interlock component moves to release the latching arm upon movement of the interlock component towards its second position.
11. The device according to claim 1, comprising a securing mechanism for securing the interlock component in the first position, wherein the securing mechanism is releasable upon movement of an operating member of the device to allow movement of the interlock component to the second position.
12. The device according to claim 11, wherein movement of the operating member causes turning movement of the interlock component relative to the housing thereby to release the securing mechanism.
13. The device according to claim 11, wherein the operating member comprises a dose selector of the device, and wherein the securing mechanism releases the interlock component when a non-zero dose is selected.
14. The device according to claim 11, wherein the securing mechanism comprises a securing formation positioned for engagement with a stop formation to prevent movement of the interlock component out of the first position and movable out of engagement with the stop formation to release the securing mechanism upon movement of the operating member.
15. The device according to claim 1, wherein movement of the interlock component towards the second position causes axial movement of the flexible locking member relative to the housing.
16. The device according to claim 15, comprising a ramp formation arranged to cooperate with a control formation to bend the flexible locking member upon axial movement of the flexible locking member relative to the housing.
17. The device according to claim 16, wherein the ramp formation is disposed on the flexible locking member and wherein the control formation is associated with the housing.
18. The device according to claim 16, wherein the flexible locking member comprises a guide surface disposed on a distal side of the ramp formation, the guide surface being arranged to cooperate with the control formation upon further axial movement of the flexible locking member relative to the housing.
19. The device according to claim 1, wherein movement of the interlock component towards the second position causes movement of the trigger button relative to the housing from a stowed position to the working position.
20. The device according to claim 19, wherein the working position is proximal to the stowed position and a trigger position.
21. The device according to claim 1, wherein the interlock component is arranged for axial movement with respect to the housing.
22. The device according to claim 21, wherein a distal part of the interlock component protrudes from a distal end of the housing when the interlock component is in the first position, and wherein the second position is disposed proximally with respect to the first position.
23. An injection device for delivery of a medicament from a container having an outlet at a distal end of the container and a stopper for containing the medicament in the container, the device comprising: a housing for receiving the container; a drive mechanism arranged to move a drive element in a distal direction to cooperate with the container upon operation of the drive mechanism; an interlock component received in the housing and arranged for movement with respect to the housing from a first position to a second position to switch the drive mechanism from a locked state to an operating state; and a securing mechanism for securing the interlock component in the first position, wherein the securing mechanism is releasable upon movement of an operating member of the device to allow movement of the interlock component to the second position, wherein movement of the operating member causes turning movement of the interlock component relative to the housing thereby to release the securing mechanism.
24. The injection device according to claim 23, wherein the operating member comprises a dose selector of the device, and wherein the securing mechanism releases the interlock component when a non-zero dose is selected.
25. The injection device according to claim 23, wherein the securing mechanism comprises a securing formation positioned for engagement with a stop formation to prevent movement of the interlock component out of the first position and movable out of engagement with the stop formation to release the securing mechanism upon movement of the operating member.
26. A device for delivery of a medicament from a container having an outlet at a distal end of the container and a stopper for containing the medicament in the container, the device comprising: a housing; a plunger arranged to move in a distal direction to cooperate with the container; a drive mechanism comprising a trigger button, the drive mechanism being arranged to hold the plunger in a starting position and to move the plunger in the distal direction from the starting position upon displacement of the trigger button from a working position to a firing position; an interlock component received in the housing and arranged for movement with respect to the housing from a first position to a second position; and at least one flexible locking member arranged to cooperate with a stop face associated with the housing to prevent displacement of the trigger button to the firing position when the interlock component is in the first position, wherein the at least one flexible locking member is located on the interlock component and comprises a blocking face arranged to block distal movement of the trigger button when the flexible locking member cooperates with the stop face, wherein movement of the interlock component towards the second position causes bending of the flexible locking member away from the stop face to allow displacement of the trigger button to the firing position, and wherein the at least one flexible locking member further comprises a proximal end face abutting the trigger button to block distal movement of the trigger button when the flexible locking member cooperates with the proximal end face.
Description
(1) Embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings in which like reference numerals are used for like features, and in which:
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(51) Referring first to
(52) Referring additionally to
(53) A shield 30 is removably attached to the distal end portion 14 of the syringe body 12. In this example, the shield 30 is of a type known in the art as a rigid needle shield and comprises an elastomeric insert or inner shield 32 having a funnel-shaped cavity into which the needle 16 is inserted, and a rigid outer cap or cover 34. The shield 30 serves to seal the needle 16 to preserve sterility of the needle 16 and to prevent leakage of medicament 20 during transport and storage of the device 100.
(54) The syringe body 12 is received in a carrier assembly 220. The carrier assembly is guided for axial movement within the front housing body 110 by an interlock component 250, which is arranged concentrically around the carrier assembly 220. An interlock spring 221 acts to bias the carrier assembly 220 and the interlock component 250 apart. The carrier assembly 220 and the interlock component 250 are shown in isolation in
(55) The interlock component 250 also guides a shuttle member 280 for axial movement with respect to the front housing body 110. The shuttle member 280 cooperates with the cap 180 to form part of a priming mechanism of the device 100, as will be explained below. In the initial state of the device, the shuttle member 280 is disposed concentrically around the shoulder 18 of the syringe body 12. The shuttle member 280 and the cap 180 are shown in isolation in
(56) The device 100 also includes a piston or plunger 300 having a priming pin 302. The plunger 300 is rotatable with the rear housing body 140 and, in use, is guided for axial movement by the front housing body 110. The plunger 300 and the front housing body 110 are shown in isolation in
(57) The device 100 is further provided with a drive mechanism arranged to hold the plunger 300 in a starting position relative to the front housing body 110 and to move the plunger 300 in the distal direction from the starting position to engage with the stopper 22 of the syringe 10. As will be explained in more detail below, the drive mechanism includes a drive spring 330 that acts between the plunger 300 and the rear housing body 140 to bias the plunger 300 in the distal direction, and a latching arrangement for latching the plunger 300 in the starting position and for releasing the plunger 300 when the trigger button 200 is depressed.
(58) Referring now to
(59) A proximal end of the sleeve 224 extends beyond the proximal end of the carrier support 222 to define an annular damping element 226. Distal movement of the sleeve 224 with respect to the carrier support 222 is prevented by a shoulder 228 provided at the proximal end of the damping element 226. Rotation of the sleeve 224 with respect to the carrier support 222 is prevented by locating tabs 229 that extend radially from the damping element 226. The shoulder 228 and the locating tabs 229 abut the proximal end of the sleeve 224. The sleeve 224 may be further secured to the carrier support 222 by any suitable means, for example by chemical and/or mechanical bonding.
(60) Adjacent to its distal end, the internal surface of the bore 225 of the sleeve 224 is provided with a deformable projection in the form of an annular rib 230. When the syringe body 12 is in place in the sleeve 224, the rib 230 deforms against the syringe body 12 to increase further the frictional force that acts between the sleeve 224 and the syringe body 12.
(61) The carrier support 222 is provided with distally-extending guide legs 232. In this example, three guide legs 232 are present, but any suitable number of guide legs could be provided. Each guide leg 232 is arcuate in cross-section so that the three legs 232 together define a tubular form that is coaxial with the longitudinal axis of the device 100. The proximal end of each guide leg 232 is attached to the carrier support 222, with a proximal part of the inner face of each guide leg 232 in contact with a corresponding locating tab 229, while the distal end of each guide leg 232 is free. In this way, the distal ends of the guide legs 232 are able to flex radially with respect to the carrier support 222 so that each guide leg 232 defines a beam element of the carrier support 222.
(62) The guide legs 232 are spaced angularly around the carrier support 222, so as to define longitudinally-extending channels 234 between the adjacent guide legs 232. Each guide leg 232 is provided with an elongate latch member 236 disposed in a cut-out 237 of the leg 236.
(63) The distal end of each latch member 236 is attached to the leg 232. The proximal end of each latch member 236 is wedge-shaped to define a ramped face 238 that projects radially beyond the outer surface of the respective leg 232. The proximal end face of each latch member 232 defines a blocking face 239 disposed perpendicular to the axis of the device 100.
(64) The outside surface of each guide leg 232 is provided with three axially-spaced, circumferentially-extending projections. A blocking projection 240 having a proximally-directed face 241 is disposed adjacent to the distal end of each guide leg 232. A stop projection 242 having a distally-directed face 243 is spaced proximally from each blocking projection 240 and approximately adjacent to the distal end of the sleeve 224. A lock projection 244, having ramped proximal and distal faces 245, 246, is disposed between the blocking projection 240 and the stop projection 242 on each guide leg 232.
(65) A pair of elongate ribs or rails 247 are provided on the inner surface of each guide leg 232. One rail 247 is provided on each side of the guide leg 232, so that each rail 247 runs adjacent to one of the channels 234 between the guide legs 232. Each rail 247 starts adjacent to the lock projection 244 and extends proximally towards the fixed proximal end of the respective guide leg 232. The rails 247 are interrupted by notches 248 formed in the sides of each guide leg 232. Each notch 248 is positioned intermediate the lock projection 240 and the stop projection 242 on the respective guide leg 232.
(66) Referring back to
(67) Referring additionally to
(68) The distal ends of the guide arms 252 are attached to a tubular sleeve part 258 of the interlock component 250. A distal end part of the sleeve part 258 forms a tubular needle shroud 260 having a distal end face 262. Three longitudinally-extending guide slots 264 are formed in the sleeve part 258 adjacent to the needle shroud 260.
(69) The sleeve part 258 is also provided with a clip formation 266 in the form of an annular projection having a ramped distal face 267 and a proximal face 268 that lies perpendicular to the axis of the device 100. The clip formation 266 is spaced from the needle shroud 260 and is split into three arcuate parts by the guide slots 264.
(70) A pair of interlock fingers 270 project proximally from the ring part 254 of the interlock component 250. Each interlock finger 270 has an aperture or cut-out 272 adjacent to its proximal end. A support pad 274 is disposed on the inside surface of each interlock finger 270 on a proximal side of the respective aperture 272. As will be explained in more detail below, the interlock fingers 270 form part of a locking mechanism for the trigger button 200.
(71) Referring back to
(72) The shuttle member 280 is guided for axial movement in the device 100 by the interlock component 250. Referring additionally to
(73) The inner surface of the shuttle member 280 is provided with a pair of circumferentially-extending collar projections or ribs 284. A central portion of each rib 284 is extended radially to form a carrier tab 286 for engagement with the shoulder 18 of the syringe body 12, as will be explained later.
(74) Referring to
(75) The cap 180 is dimensioned to fit over the front housing body 110 of the device 100. A guide key 194 is provided on the internal surface of the outer wall 182 of the cap 180 for engagement with the front housing body 110, and cut-outs 196 are provided in the outer wall 182 to allow the window 114 of the front housing body 110 to be seen when the cap 180 is in place.
(76) Referring to
(77) Referring back to
(78) The proximal part 118 of the front housing body 110 serves as a guide for the plunger 300. To this end, the internal surface of the proximal part 118 (shown most clearly in
(79) The channels 126 are equally spaced around the circumference, except that the spacing between the shortest channel 126a and the longest channel 126b is increased to define a proximally-directed surface or land 130 on each side of the front housing body 110. A stop rib 132 extends proximally from one side the land 130, adjacent to the longest channel 126b.
(80) A detent ring 134 is disposed adjacent to the proximal ends of the channels 126, at the proximal end of the front housing body 110. A plurality of V-shaped indents 136 are arranged around one half of the detent ring 134, with one indent 136 being provided for each opposite pair of channels 126. The spacing of the indents 136 corresponds to the spacing of the channels 126. A cut-out is provided in the proximal end of the front housing body 110 to form an indicator window 138 adjacent to the detent ring 134.
(81) Referring back to
(82) The plunger body 306 extends distally from the end plate 308 to act as a guide for the drive spring 330. The plunger body 306 has an external flange that provides a spring seat 310 for the distal end of the drive spring 330. The spring seat 310 is provided with a proximally-extending outside rim 312 having four extended parts 314 that help to retain the drive spring 330 on the spring seat 310.
(83) As shown most clearly in
(84) A distal end part of the plunger body 306 projects beyond the spring seat 310. A feedback projection or tab 318 is disposed on the outer surface of the distal end part for engagement with the feedback component 380 upon operation of the device 100, as will be described below.
(85) Two proximally-projecting latching arms 320 are attached to the end plate 308 of the plunger 300. An inwardly-facing clip formation 322 is provided at the proximal end of each latching arm 320. Each clip formation 322 has a ramped proximal face 323 and a distal face 324 that is substantially perpendicular to the axis of the device 100. Two arcuate slots 326 are formed at the peripheral edge of the end plate 308 adjacent to the latching arms 320. The slots 326 are shaped to allow the interlock fingers 270 of the interlock component 250 to pass through the slots 326 to extend towards the trigger button 200.
(86) Referring to
(87) A pair of retaining arms 208 extend distally from the chassis 202. Each retaining arm 208 is provided with an outwardly-facing clip formation 210 at its distal end, and the retaining arms 208 are arranged diametrically opposite one another on the chassis 202. A pair of latch release pins 212 also extend distally from the chassis 202. The latch release pins 212 are arcuate in cross-section and are arranged diametrically opposite one another and at right angles to the retaining arms 208.
(88) As shown most clearly in
(89) Referring to
(90) Proximal to the flange 144, a bridge part 148 extends across the bore of the rear housing body 140. The bridge part 148 is attached to the flange 144 by way of a pair of upstanding arcuate guide walls 150, shown most clearly in
(91) Arcuate slots 154 are formed in the bridge part 148 adjacent to the inside surface of each guide wall 150 to accept the interlock fingers 170 of the interlock component 170 and the latching arms 320 of the plunger 300. At each end of each slot 154, a guide ramp 156 is provided. The guide ramps 156 extend proximally from the bridge part 148, and each guide ramp 156 has a ramped inside face 158 and a proximal end face 160 that lies perpendicular to the axis of the device 100. The proximal side of the bridge part 148 is provided with two raised contact pads 162 disposed adjacent to the inside edge of each slot 154. As shown in
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(93) The feedback component 380 is provided with a pair of clip arms 384 disposed on opposite sides of the feedback component 380. Each clip arm 384 is attached to the feedback component 380 at its distal end and has an outwardly-facing clip formation 386 at its proximal end. Each clip formation 386 has a ramped distal face 387 and a proximal face 388 that lies perpendicular to the axis of the device 100. Distal to each clip arm 384, the outer surface of the feedback component 380 is provided with a pair of retaining ribs 390, 391 that are spaced apart in the axial direction.
(94) Referring back to
(95) The shield retainer arms 188 embrace the needle shield 30 and the clip formations 190 of the retainer arms 188 are clipped to the proximal end of the needle shield 30. The shuttle member 280 is supported by the proximal ends of the retainer arms 188, with the carrier tabs 286 projecting between the shoulder 18 of the syringe body 12 and the proximal end of the needle shield 30.
(96) The clip formation 266 of the sleeve part 258 of the interlock component 250 is engaged with the support tabs 125 of the front housing body 110, so that the interlock component 250 is held in a first position with respect to the front housing body 110, in which the distal end face 262 of the needle shroud 260 projects beyond the distal end face 112 of the front housing body 110.
(97) The plunger 300 is retained in a starting position by engagement of the clip formations 322 of the latching arms 320 with the bridge portion 148 of the rear housing body 140. The drive spring 330 is compressed between the spring seat 310 of the plunger 300 and the flange 144 of the rear housing body. When the plunger 300 is in its starting position, the priming pin 302 is received in the socket 164 of the bridge part 148 of the rear housing body. The length of the priming pin 302 is such that the contact disc 307 of the priming pin 302 is disposed distally with respect to the distal end of the plunger rod 304.
(98) The feedback component 380 is retained in a stowed position in the device 100 by engagement of the retaining ribs 390, 391 with the front housing body 110. The distal retaining rib 391 engages with a proximal end of the window 114, and the proximal retaining rib 390 engages with an internal step in the front housing body 110, adjacent to the external step 120.
(99) The carrier assembly 220 is locked in an initial axial position by a carrier lock arrangement. Referring to
(100) To ensure that the guide legs 232 cannot deflect inwardly to allow the lock projection 244 to move past the collar 124, the interlock component 250 braces the guide legs 232, as follows. With the interlock component 250 in its first position, as in the initial state of the device, the tabs 256 provided on the sides of the guide arms 252 of the interlock component 250 are positioned to bear against the rails 247 of the guide legs 232. The interaction between the tabs 256 and the rails 247 serves to brace the guide legs 232 against deflection and to wedge each leg 232 against the respective collar 124, so that the tabs 256 act as bracing formations.
(101) In the initial state of the device, the cap 180 is locked to the front housing body 110 by virtue of the engagement between the key 194 of the cap 180 and the keyway 117 of the front housing body 110. To prepare the device 100 for use, the cap 180 must be removed. As shown in
(102) Unlocking of the cap 180 operates the priming mechanism of the device 100, in which the shuttle member 280 moves the syringe body 12 in the proximal direction with respect to the front housing body 110.
(103) Referring to
(104) Movement of the syringe in the proximal direction has several effects, as will now be explained with reference to
(105) As shown in
(106) Referring to
(107) Turning to
(108) Proximal movement of the syringe body 12 also causes the stopper 22 to move against the contact disc 307 of the priming pin 302, as shown in
(109) Advantageously, movement of the stopper 22 from its initial position to the known, primed position ensures that the quantity of medicament injected upon subsequent activation of the drive mechanism of the device 100 is not dependent on the initial position of the stopper 22 after manufacture of the syringe 20, thereby increasing the accuracy of the dose delivered.
(110) Proximal movement of the syringe body 12 to its starting position also causes the flange 24 of the syringe 10 to become spaced from the damping element 226 of the sleeve 224 of the carrier assembly 220. This ensures that, upon subsequent activation of the drive mechanism, the syringe body 12 will move in the distal direction with respect to the carrier assembly 220 during a final part of an insertion stroke of the syringe 10, as will be discussed further below.
(111) Referring back to
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(113) The next stage in operation of the device 100 is to set the dosage to be delivered. Referring to
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(115) To select a dose, the rear housing body 140 is rotated with respect to the front housing body 110, as shown in
(116) It will be appreciated that the dose could instead be selected before removal of the cap 180. In this case, the rear housing body 140 acts as the operating member for the priming mechanism. Referring back to
(117) In any event, once the cap 180 has been removed and the dose has been selected, the distal end of the device 100 can be placed against an injection site ready for injection. To prevent accidental operation of the device 100 before the device has been placed against the injection site, a locking mechanism for the trigger button is provided, as will now be explained with reference to
(118)
(119) As seen most clearly in
(120) Referring back to
(121) As the interlock component 250 moves towards its second position, the proximal end faces 271 of the interlock fingers 270 contact the distal ends of the locking fingers 214. Further proximal movement of the interlock component 250 pushes the locking fingers 214, and therefore the trigger button 200, in the proximal direction. As shown most clearly in
(122) As a result, the distal ends of the locking fingers 214 move radially inwards with respect to the proximal end faces 160 of the guide ramps 156. At the same time, the trigger button 200 moves proximally to a working position. This proximal movement of the trigger button 200 from the stowed position to the working position provides a visual indication to the user that the trigger button 200 has been unlocked and that the device 100 is ready for injection. In some variants of the invention, however, the trigger button 200 is initially in the working position and does not move proximally upon movement of the interlock component 250. For example, the control rib 152 may be omitted and the distal ends of the locking fingers 214 may be shaped to wedge behind the locking fingers 214 to bend the locking fingers 214 inwardly to clear the proximal faces 160 of the guide ramps 156.
(123) As shown in
(124) Because the locking fingers 214 have been bent inwardly by the control rib 152, the distal ends of the locking fingers 214 now clear the proximal end faces 160 of the guide ramps 156, so that distal movement of the firing button 200 with respect to the rear housing body is no longer blocked.
(125) It is now possible for the user to depress the trigger button 200 to displace the button 200 in the distal direction from the working position to a firing position, as shown in
(126) Although not shown in
(127) Movement of the interlock component 250 into its second position also serves to unlock the carrier lock arrangement. Referring back to
(128) Referring back to
(129) The distal end of the plunger rod 304 transfers the force of the drive spring 330 to the stopper 22 of the syringe 10. Initially, as a result of the friction between the stopper 22 and the syringe body 12 and the fluid flow resistance through the needle 16, the syringe body 12 moves together with the stopper 22 to displace the syringe body 12 distally from its starting position to begin an insertion stroke of the syringe 10.
(130) A distal force is also applied to the carrier assembly 220 by the syringe body 12, as a result of the frictional gripping force applied to the syringe body 12 by the carrier sleeve 224. This distal force is sufficient to allow the lock projections 244 to pass the collar 124 as described above. The carrier assembly 220 therefore moves distally, together with the syringe 10, until the carrier assembly 220 reaches a stop position.
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(132) After the carrier assembly 220 has reached the stop position, further distal movement of the plunger 300 causes movement of the syringe body 12 in the distal direction with respect to the carrier assembly 220. Distal movement of the syringe body 12 relative to the carrier assembly 220 and the front housing body 110 continues until the flange 24 of the syringe 10 abuts the damping element 226 of the sleeve 224 of the carrier assembly 220, as shown in
(133)
(134) As the insertion stroke continues, the syringe body 12 moves distally with respect to the carrier assembly 220 by a distance D, to bring the flange 24 of the syringe 10 into contact with the damping element 226, as shown in
(135) Advantageously, when the syringe body 12 moves relative to the carrier assembly 220, the sleeve 224 of the carrier assembly 220 acts to reduce the velocity of the syringe 10 before the flange 24 contacts the damping element 226. This is because the sleeve 224, and in particular the annular rib 230 of the bore 225 of the sleeve 224, applies a frictional retardation force to the syringe body 12 that retards the movement the syringe 10 against the influence of the insertion force. As a result, the momentum of the syringe 10 is reduced before the flange 24 contacts the damping element 226, to reduce the impact forces experienced by the syringe 10 and the device 100 at the end of the insertion stroke. Once the flange 24 contacts the damping element 226, the damping element 226 deforms to help absorb some of the impact energy, further reducing the risk of damage to the syringe 10 and the device 100.
(136) Once the syringe 10 has reached the insertion position, the stopper 22 is moved distally by the plunger rod 304 in a medicament delivery stroke to eject medicament through the needle 16 for injection.
(137) Once the plunger guide formations 316 reach the distal ends 128 of the selected channels 126, axial movement of the plunger 300 stops and the delivery stroke ends.
(138) To avoid proximal movement of the syringe 10, which could push the stopper 22 against the plunger rod 304 and cause an overdose of medicament, the carrier assembly 220 is arranged to lock in its stop position. As shown in
(139)
(140) As seen most clearly in
(141) After the end-of-dose indications have occurred, the user can remove the device 100 from the injection site by moving the device 100 in the proximal direction to withdraw the needle 16. As the distal end 112 of the front housing body 110 moves away from the injection site, the interlock component 250 moves in the distal direction, under the influence of the interlock spring 221, to keep the distal end face 262 of the needle shroud 260 in contact with the injection site.
(142) Distal movement of the interlock component 250 relative to the front housing body 110 continues until the ring part 254 of the interlock component 250 fouls the support arms 122 of the front housing body 110, as shown in
(143) To avoid proximal movement of the interlock component 250, which could otherwise expose the needle 16, the interlock component 250 locks into the fully-deployed position under the influence of the interlock spring 221. As shown most clearly in
(144) With the device 100 in the locked-out state, shown in
(145) The exemplary device 100 described with reference to
(146) By way of example, a device 500 according to a second embodiment of the invention will now be described with reference to
(147) Referring first to
(148) The front housing body 510 houses a pre-filled syringe 10 having a needle shield 30. The body 12 of the syringe 10 is received in a carrier assembly 620. As in the first embodiment, in this second embodiment the carrier assembly 620 is guided for axial movement within the front housing body 510 by an interlock component 650, which is arranged concentrically around the carrier assembly 620. An interlock spring 621 acts to bias the carrier assembly 620 and the interlock component 650 apart. In the initial state of the device 500, illustrated in
(149) As in the first embodiment, the interlock component 250 can be moved proximally to a second position to prepare the device for operation. The carrier assembly 620 and the interlock component 650 of the device 500 of the second embodiment are shown in isolation in
(150) The rear housing body 540 houses the latch arrangement for the plunger 700 and the interlock mechanism for the trigger button 600. A drive spring 730 acts between the rear housing body 540 and the plunger 700 to bias the plunger 700 in the distal direction, and a feedback component 780 is cooperable with the plunger 700 to provide an end-of-dose indication. The plunger 700, the interlock button 600 and the rear housing body 540 are shown in isolation in
(151) The components of the device 500 are generally similar to the corresponding components of the device 100 of the first embodiment and cooperate in similar ways during operation. As noted above, however, the device 500 of the second embodiment of the invention does not include a priming mechanism. Accordingly, as best seen in
(152) It is however still desirable to ensure that the syringe 10 is positioned in a starting position with the flange 24 of the syringe 10 spaced from the proximal end of the carrier assembly 620 before operation of the device 500. As in the first embodiment, with the syringe 10 positioned in this way before operation of the device 500, relative movement of the syringe 10 with respect to the carrier assembly 620 during the final part of the insertion stroke of the syringe 10 causes retardation of the movement of the syringe 10 due to the frictional retardation force applied to the syringe body 12 by the sleeve 624 of the carrier assembly 620.
(153) Accordingly, in the device 500 of the second embodiment of the invention, the syringe 10 is positioned in its starting position during assembly of the device 500. To guard against movement of the syringe 10 out of the staring position before operation of the device 500, particularly during removal of the needle shield 30 by the cap 580, the carrier assembly 620 is modified to include clamping means arranged to apply a releasable clamping force to the syringe body 12, by way of the sleeve 624, to restrict axial movement of the syringe 10 with respect to the carrier assembly 620.
(154) To this end, referring to
(155) The proximal end 802 of each clamping leg 800 is attached to the carrier support 622. A distal part 804 of each clamping leg 800 is free to move with respect to the fixed proximal end 802, so that the clamping legs 800 can flex or bend. The outer surface of the distal part 804 of each clamping leg 800 defines a control surface 806 of the clamping leg 800.
(156) As seen most clearly in
(157) Referring again to
(158) Each of the control surfaces 806 of the clamping legs 800 cooperate with a corresponding control element provided on the interlock component 650. Referring to
(159)
(160) As in the first embodiment of the invention, in this second embodiment the interlock component 650 also cooperates with the guide legs 624 of the carrier assembly 620 to lock the carrier assembly 620 in its initial position with respect to the front housing body 510 when the interlock component 650 is in its first position. In this way, when the interlock component 650 is in the first position, movement of the syringe 10 with respect to the front housing body 510 is prevented by a combination of two features, namely the carrier lock arrangement which locks the carrier assembly 620 relative to the front housing body 510, and the clamping mechanism described above with reference to
(161) Upon removal of the cap 580, the syringe 10 therefore remains fixed in its starting position, with the flange 24 of the syringe body 12 spaced from the damping element 626 at the proximal end of the carrier assembly 620.
(162) To allow the device 500 to be fired, the carrier assembly 620 must be released from its locked state to allow the syringe 10 and the carrier assembly 620 to move distally during the insertion stroke. Also, the clamping force applied by the clamping legs 800 must be removed, to allow the syringe 10 to move distally with respect to the carrier assembly 620 at the end of the insertion stroke, after the carrier assembly 620 has reached its stop position. Release of the carrier lock mechanism and removal of the clamping force are both achieved by movement of the interlock component 650 towards its second position when the device 500 is pressed against the injection site, moving the distal end face 662 of the needle shroud 660 proximally with respect to the front housing body 510.
(163) Referring back to
(164) It will be appreciated that, although a clamping force is no longer applied to the sleeve 624 by the clamping leg 800 under the influence of the rib 810, the syringe body 12 is still retained in position with respect to the carrier assembly 620 by the residual elastomeric clamping force that results from compression of the sleeve 624 between the syringe body 12 and the carrier support 622.
(165) As in the first embodiment of the invention, movement of the interlock component 650 from the first state to the second state also unlocks the trigger button 600 to allow the trigger button to be moved to a firing position to release the plunger. As noted above, the device 500 of the second embodiment of the invention includes a modified locking mechanism for the trigger button 600, as will now be described.
(166) Referring back to
(167) Turning to
(168) An outwardly-facing clip formation 722 is provided at the proximal end of each latching arm 720. Each clip formation 722 has a ramped proximal face 723 and a distal face 724 that is substantially perpendicular to the axis of the device 500. A slot 726 is formed in the end plate 308 between each of the latching arms 720 in each pair of latching arms 720. The slots 726 allow the interlock fingers 670 of the interlock component 650 to pass through the slots 726 to extend towards the trigger button 600.
(169) The plunger 700 is otherwise similar to the plunger 300 of the first embodiment of the invention, except that, in the second embodiment, the plunger rod 704 is solid and no priming pin is provided.
(170) Referring to
(171) The rear housing body 540 is also of a simplified design in this second embodiment of the invention. As shown in
(172) Referring now to
(173) The interlock fingers 670 extend between the adjacent latching arms 720 of each pair of latching arms 720, through the slots 726 in the plunger end plate 308, so that the head part 674 of each interlock finger 670 is located between the opposing side faces of the adjacent latching arms 720. With the head parts 674 in this position, inward flexing of the latching arms 720 cannot occur, so that the interlock fingers 670 help to prevent premature disengagement of the latching arms 720 from the control collar 552.
(174) The interlock fingers 670 also engage with the control collar 552. The blocking face 675 of each interlock finger 670 abuts the stop face 560 of the control collar 552, which blocks distal movement of the interlock fingers 670 relative to the rear housing body 540. In turn, distal movement of the trigger button 600 is prevented, because the distal end of the release sleeve 612 of the trigger button 600 contacts the proximal end face 671 of each interlock finger 670.
(175) Accordingly, distal movement of the trigger button 600 to its firing position is blocked when the interlock component 650 is in its first position.
(176) When the device 500 is placed against the injection site, the interlock component 650 moves proximally with respect to the rear housing body 540, towards the second position. This causes the distally-facing ramp formations 677 of the interlock fingers 670 to ride over the distal edge of the control collar 552, which bends the distal parts of the interlock fingers 670 inwardly, moving the proximal end faces 671 away from the release sleeve 612 of the trigger button 200, with the chamfered outer sides 673 allowing the interlock fingers 670 to clear the release sleeve 612.
(177) Initially, cooperation between the ramp formations 677 and the control collar 552 causes a relatively large amount of inward radial displacement of the end faces 671 of the interlock fingers 670. On continued proximal movement of the interlock fingers 670, the ramp formations 677 clear the control collar 552, and the distal edge of the control collar 552 instead cooperates with the guide surface 679 of each interlock finger 670. This results in further bending of the interlock fingers 670 as they move proximally with respect to the control collar 552.
(178)
(179) With the interlock fingers 670 bent inwardly, the blocking faces 675 of the interlock fingers 670 are now clear of the stop face 560 of the control collar 552, and are moved to a position in which the head parts 674 of the interlock fingers 670 no longer prevent inward flexing of the latching arms 720.
(180) Accordingly, with the interlock component 650 in its second position, the trigger button 600 is unlocked for movement in the distal direction to its firing position. Distal movement of the trigger button 600 with respect to the rear housing body 540 causes the latch release sleeve 612 to bear against the ramped proximal face 723 of the clip formation 722 of each latching arm 720, bending the latching arms 720 radially inwardly. In this way, the distal face 724 of the clip formation 722 of each latching arm 720 moves to clear the stop face 560 of the control collar 552, allowing the plunger 700 to move distally under the influence of the drive spring 730.
(181) As in the first embodiment of the invention, movement of the plunger 700 first causes an insertion stroke of the syringe 10, in which the syringe 10 and the carrier assembly 620 move together in the distal direction. The carrier assembly 620 then locks in its stop position, and in a final part of the insertion stroke the syringe 10 moves distally relative to the carrier assembly 620, causing a reduction in the acceleration of the syringe 10 until the flange 24 comes to a stop against the damping element 626 of the carrier assembly 620. The plunger 700 then moves the stopper 22 of the syringe 10 in the distal direction, to expel the desired quantity of medicament through the needle 16. At the same time, the plunger 700 deploys the feedback component 780. Once the plunger 700 reaches its stop position, the device 500 can be withdrawn from the injection site, causing distal movement of the interlock component 250 and deployment of the needle shroud 760 into its locked-out position.
(182) It will again be appreciated that the various features of the device of the second embodiment of the invention could be used alone or in suitable combinations in other injection devices. For example, the trigger button locking mechanisms of the device of the second embodiment of the invention could be used with the device of the first embodiment of the invention, or vice versa.
(183) In both of the above-described embodiments of the invention, it may be desirable to provide additional security against unintentional operation of the device. For example, in the above-described examples, movement of the trigger button 200, 600 is blocked when the interlock component 250 is in the first position, and the trigger button 200, 600 cannot be operated until the interlock component 250 has moved towards the second position. In normal use, the interlock spring 221 biases the interlock component into the first position, and when the cap 180, 580 is in place it is not possible for a user to apply the necessary force to the interlock component 250 to displace it to the second position. However, even when the cap 180, 580 is in place, movement of the interlock component 250 against the bias of the interlock spring 221 could still occur, for example if the device were to be dropped or otherwise subjected to a shock load. In particular, dropping of the device onto its proximal end may cause displacement of the interlock component 250 and allow the trigger button 200, 600 to move to the firing position, resulting in an unintentional firing of the device.
(184) In some cases, sufficient protection against unintentional firing in such conditions can be provided by selection of a suitably stiff interlock spring 221. However, it can be preferable to use a relatively weak interlock spring 221, to minimise the force that must be applied to press the device against the injection site in use.
(185)
(186) In this variant, the interlock component 250a is a two-part assembly, in which the distal ends of the guide arms 252a join with an annular upper sleeve part 258a that terminates at its distal end with a clip formation 258b. A lower sleeve part 258c of the interlock component 250a engages with the clip formation 258b. The upper and lower sleeve parts 258a, 258c together provide generally the same functionality as the single-piece interlock component 250 of the device of
(187) As in the device of
(188) The interlock component 250a is provided with a pair of diametrically opposed securing projections 253 that are disposed on the outside surface of the upper sleeve part 258a. A corresponding pair of inwardly-projecting stop formations 124a are formed on the support arms 122 of the front housing body 110. The stop formations 124a are disposed distally with respect to the respective collars 124 of each support arm 122.
(189) Referring to
(190) During the normal operating sequence of the device, the rear housing body 140 is turned to select a non-zero dose. The resulting turning movement of the upper sleeve part 258a of the interlock component 250a moves the securing projections 253 out of angular alignment with the stop formations 124a, as shown in
(191) In this way, cooperation between the securing projections 253 of the interlock component 250a with the stop formations 124a of the front housing body 110 serves to secure the interlock component 250a in the first position to reduce the risk of accidental firing of the device, for example if the device were to be dropped. Another benefit of this arrangement is that the interlock component 250a cannot be moved out of its first position and the device cannot be fired until a non-zero dose has been selected by the user.
(192) In another variant of the device (not illustrated), cooperation between the interlock component and the cap acts to secure the interlock component in the first position whilst the cap is in place. For example, the cap may be shaped to wedge the interlock component against the front housing body to prevent proximal movement of the interlock component until the cap is removed.
(193)
(194) The sleeve 224a defines a bore 225a for receiving the syringe body 12. A plurality of deformable wedge-shaped projections 230a are arranged around the internal surface of the bore 225a. In this case, two arcuate wedge-shaped projections 230a are provided, although fewer or more such projections could be present. The proximal end of the sleeve 224a extends beyond the proximal end of the carrier support 222a to provide an annular damping element 226a.
(195) The sleeve 224a, the projections 230a and the damping element 226a provide the same functionality as the equivalent parts of the carrier assembly 220 described above with reference to
(196) In the
(197)
(198) As the interlock component 250a is moved from the first position to the second position, each tab 256a moves into the clearance provided by a notch 248a in the adjacent guide leg 232a of the carrier support 222a. When in this position, the guide legs 232a are no longer braced against deflection by the interlock component 250a, so that the legs 232a can deflect inwardly to disengage from the collars 124 and release the carrier assembly 220a from its initial position during the insertion stroke of the device. It will be noted that, in this example, each guide arm 252a of the interlock component 250a is provided with a tab 256a on only one side and, correspondingly, each guide leg 232a of the carrier support 222a is provided with a notch 248a on only one side. It will however be appreciated that tabs and notches could be provided on both sides of the guide arms and guide legs respectively, if desired. In a further variant, the tabs are provided on the carrier support, and corresponding notches are provided in the interlock component.
(199) In another variant of the device (not illustrated), a modified priming mechanism is provided. In this case, the shuttle member described above with reference to the first embodiment of the invention is omitted, and instead carrier tabs or other suitable carrier formations are provided on the cap itself for moving the syringe body in the proximal direction. In this case, the cap is guided for proximal movement during removal of the cap to displace the syringe body in the proximal direction, for example by an inclined formation that causes the cap to move proximally as it is turned to unlock the cap from the front housing body. In such cases, suitable formations may be provided in the front housing body to prevent proximal movement of needle shield and release the needle shield from the needle during the priming operation.
(200) As will be apparent to the skilled person, many further variations and modifications of the devices and features described above are possible without departing from the scope of the invention as defined in the appended claims.