Injection and transfer device trainers

Abstract

Reusable training versions of injection devices and transfer devices for transferring medication from vials to on-body injection devices include features that permit simulated operation of the injection and transfer devices while permitting them to be reset for future use after a training or demonstration session.

Description

INJECTION AND TRANSFER DEVICE TRAINERSINVENTORS: Rowan Converse, Kory GunnersonCLAIM OF PRIORITY

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 637,713, filed April 23, 2024, the contents of which are hereby incorporated by reference in their entirety.FIELD OF THE INVENTION

[0002] The present subject matter relates generally to on-body injection devices and transfer devices for transferring medication from vials to on-body injection devices and, in particular, to reusable training devices or trainers for instructing users on the proper use of such injection and transfer devices.BACKGROUND

[0003] Injection devices that are worn by a patient temporarily or for extended periods (on-body injection devices) are well known in the medical field. Transfer devices are often used to transfer liquid medication from vials to such on-body injection devices prior to placement on a patient.

[0004] Potential users of on-body injection devices and transfer devices must be trained on how to properly use them. Additional situations may occur where demonstration of use of the injection and transfer devices is needed. Reusable training versions of the above injection and transfer devices are desirable for such purposes. Such training versions would include features that permit simulated operation of the injection and transfer devices while permitting them to be reset for future use after a training or demonstration session.SUMMARY

[0005] There are several aspects of the present subject matter which may be embodied separately or together in the devices and systems described and claimed below. These aspects may be employed alone or in combination with other aspects of the subject matter described herein, and the description of these aspects together is not intended to preclude the use of these aspects separately or the claiming of such aspects separately or in different combinations as set forth in the claims appended hereto.

[0006] In one aspect, a reusable injection device trainer includes an injection device housing. A push button is mounted within the injection device housing and movable between a raised position and a lowered position. A push button spring urges the push button towards the raised position. A button claw includes a pair of flex arms configured to move with the push button between the raised and lowered positions. The pair of flex arms each includes ratchet teeth positioned at a distal end thereof. A rotor is rotatably mounted within the injection device housing. The rotor includes a winding tab, a rotor gear having rotor gear teeth and a rotor insert having rotor insert teeth. The rotor gear and the rotor insert are concentrically mounted. The rotor insert teeth are configured to be engaged by the ratchet teeth of the flex arms when the push button is in the raised position and the rotor is turned in a first direction and the rotor insert teeth and the ratchet teeth are configured to be disengaged when the push button is in the lowered position or the rotor is turned in a second direction. The injection device housing includes an injection device winding slot through which the winding tab may be accessed. A rotor spring urges the rotor towards a prefill or a post-injection position. An injection device damper is configured to engage the rotor gear teeth.

[0007] In another aspect, a reusable transfer device trainer includes a transfer device housing including an injection device mounting surface featuring a winding pin slot. The transfer device housing includes a base. A vial elevator is positioned within the transfer device housing and receives a vial. The vial elevator including a camming hook. A vial elevator moves between an extended position and a retracted position within a vial elevator shaft. A cam ring is rotatably positioned around the vial elevator and includes a camming surface configured to be traversed by the camming hook as the vial elevator moves from the extended position to the retracted position whereby the cam ring rotates in a cam ring actuation direction. The cam ring includes a cam ring finger. A drum assembly includes a drum rotatably mounted within the transfer device housing and a driver pivotally attached to the drum. The driver includes a latch interface surface, a top side to which a winding pin is attached and a bottom side to which a cam follower is attached. A winder is mounted to the housing in a ratcheting manner so as to be rotatable with respect to the housing when turned in a first direction, but to engage the housing when urged in a second direction. A rotor spring is connected between the winder and the drum and urges the drum assembly to rotate in a drum actuation direction. A latch is pivotably mounted to the base and includes a latch stop. The latch is configured to rotate between a first latch position, where the latch stop engages the latch interface surface thereby preventing rotation of the drum assembly in the drum actuation direction, and a second latch position, where the latch stop disengages from the latch interface surface of the driver, when the cam ring rotates in a cam ring actuation direction so that the drum assembly may rotate in the drum actuation direction. A cam wall is mounted on the base and has a top surface. The cam wall ispositioned so that the cam follower of the driver traverses the cam wall top surface as the drum assembly rotates in the drum actuation direction so that the winding pin is raised away from the base and passes through and traverses the winding slot of the injection device mounting surface.BRIEF DESCRIPTION OF DRAWINGS

[0008] Fig. 1 is a perspective view of an embodiment of the injection device trainer of the disclosure with a top portion of the housing removed and the push button shown as transparent.

[0009] Fig. 2 is a perspective view of the injection device trainer of Fig. 1 with the top portion of the housing installed.

[0010] Fig. 3 is top plan view of the injection device trainer of Fig. 1 in a simulated prefill and post injection configuration.

[0011] Fig. 4A is a top plan view of the injection device trainer of Figs. 1 -3 in a simulated partially filled configuration.

[0012] Fig. 4B is a top plan view of the injection device trainer of Fig. 4A in a configuration simulating completion of an injection.

[0013] Fig. 4C is a top plan view of the injection trainer of Figs. 4A and 4B in a simulated post injection configuration.

[0014] Fig. 5 is an exploded perspective view of the transfer device trainer.

[0015] Fig. 6 is an enlarged exploded perspective view of the housing, winder, damper and drum gear of Fig. 5.

[0016] Fig. 7 is an enlarged perspective view of the drum of Fig. 5.

[0017] Fig. 8A is an enlarged side plan view of a driver of Fig. 5.

[0018] Fig. 8B is a perspective view of a driver of Fig. 8A.

[0019] Fig. 9A is an enlarged perspective view of the drum assembly of Fig. 5.

[0020] Fig. 9B is a perspective view of the drum assembly of Fig. 9A.

[0021] Fig. 10 is an enlarged perspective view of the base of Fig. 5.

[0022] Fig. 11 is an enlarged perspective view of the assembled transfer device trainer with the housing omitted.

[0023] Fig. 12 is enlarged plan view of the latch of the transfer device trainer of Fig. 11.

[0024] Fig. 13 is a partial plan view of a first alternative embodiment of the transfer device trainer.

[0025] Fig. 14 is a partial plan view of a second alternative embodiment of the transfer device trainer.DESCRIPTION

[0026] The embodiments of the disclosure include training versions of on-body injection devices such as the single-use injection device described in commonly assigned U.S. Patent No. 9,925,333 to Hooven et al., issued March 27, 2018, and which is hereby incorporated herein by reference in its entirety. That injection device includes a internal resilient bladder that may be filled with any suitable injectable medicament, whether drug, antibiotic, biologic or other injectable, for subcutaneous injection, typically a bolus injection, into a patient while the device is being worn by the patient. This injection device must be filled (wholly or partially) with the desired injectable before injection into the patient. The medicament is expelled from the injection device via an injection cannula that passes through a dispense port formed in the bottom of the injection device housing.

[0027] Commonly assigned U.S. Patent No. 11 ,571 ,361 to Bourelle et al., issued February ?, 2023, and U.S. Patent Application Publication No. US 2023 / 0285243, published September 14, 2023, the contents of each of which are hereby incorporated herein by reference in its entirety, disclose transfer devices for transferring an injectable into the injection device from a source such as a vial. These transfer devices drive the injectable from a vial into the injection device using pressurized gas canisters. In each transfer device, a pressurized gas canister positioned within a pressure chamber is punctured when the vial is pressed down into the device via a vial elevator, with the resulting pressurized air directed to the inverted vial to displace the injectable. As a result, the transfer devices are also single-use devices.

[0028] The vial may be a standard drug vial with a rigid container portion usually glass, open at one end and sealed by a piercable diaphragm or septum of latex, silicone or other material. The transfer devices described above receive the vial in an inverted vertical position so that the gas flows to the closed end of the vial, forcing essentially all the medicament from the vial under the force of the pressurized gas.

[0029] It should be noted that “injectable fluid,” “injectable,” “drug,” “medicament”, “medication” and like terms are used interchangeably herein.

[0030] While the embodiments disclosed below use a single vial, alternative embodiments include transfer stations that may accommodate two or more vials.

[0031] On-Body Injection Device Trainer

[0032] A reusable injection device trainer of the disclosure is indicated in general at 100 in Fig. 1 with the top portion of the housing removed. The injection device trainer 100 with the top portion of the housing 102 installed is illustrated inFig. 2. As illustrated in Figs. 1 and 2, the injection device trainer is provided with a push button 104 that is pushed to initiate a simulated injection. The push button is shown in the raised position in Figs. 1 and 2.

[0033] The internal components of the device are in a configuration associated with the injection device trainer 100 being in a pre-filled or postinjection configuration in Figs. 1-3.

[0034] As illustrated in Fig. 1 , the injection device trainer 100 includes a button claw, indicated in general at 106. The button claw features a pair of flex arms 108a and 108b joined by a bridge portion 114. The button claw 106 may optionally be integrally molded, or otherwise formed, with the push button 104 so that the push button and button claw are a single piece.

[0035] The push button 104 is mounted within the top (102 of Fig. 2) and the bottom 112 of the housing (Figs. 1 and 2) so that the button may move between the raised position illustrated in Figs. 1 and 2 and a depressed or lowered position with respect to the housing without rotating. A compression coil spring (not shown) is positioned between the underside of a bridge portion 114 of the button claw 106 and the bottom 112 of the housing and urges both the push button 104 and the button claw 106 into the raised positions shown in Figs. 1 and 2. The button claw 106 moves down with respect to the housing bottom 112 when the push button 104 is pressed.

[0036] A rotor, indicated in general at 116 in Fig. 1 is rotatably mounted to the bottom 112 of the housing. The rotor includes a rotor gear 118, a rotor cylinder 122 and a rotor insert 124 including teeth 126. As a result, all of these rotor components are free to rotate with respect to the push button 104, the button claw 106 and the bottom 112 of the housing. A gas gage flag 128 is slidably mountedto the housing bottom 112 via a flag shuttle 132 that traverses a track formed in the housing bottom and running along winding slot 134. The rotor 116 is also provided with a winding tab 136 that may be positioned adjacent to the rotor gear 118.

[0037] As illustrated in Fig. 3, an elastomeric tension dispense spring 142 is secured by a proximal end 144 to the bottom 112 of the housing. The dispense spring 142 also includes a distal end 146 which is attached to a spring hook 149 (also shown in Fig. 1 ) formed on the rotor cylinder 122. As a result, the rotor 116 is urged into the prefill or end of injection position shown in Figs. 2 and 3, with the winding tab 136 engaging rotor stop 148. As examples only, the dispense spring 142 may be constructed from rubber or silicone.

[0038] With further reference to Fig. 3, a gas gage spring 152, which may be a leaf spring, has a proximal end portion 154 secured to the rotor cylinder 122 and distal end portion 156 which urges the gas gage flag 128 towards the winding tab 136. Travel of the flag shuttle 132 towards the winding tab 136 is interrupted by a shuttle stop 162 (also shown in Fig. 1 ) when the rotor 116 is in the position illustrated in Figs. 2 and 3.

[0039] Alternative spring types including, but not limited to, coil springs, may be used in place of the elastomeric and leaf springs illustrated for the dispense spring 142 and the gas gage spring 152.

[0040] Winding and operation of the injection device trainer 100 will now be explained. Beginning with the injection device trainer 100 in the configuration illustrated in Figs. 2 and 3, the winding tab 136 is engaged by a winding pin (described with respect to the transfer device trainer below) that moves, after engagement with the winding tab 136, through the winding slot 134 in thedirection of arrow 164 in Fig. 3 and against the urging of dispense spring 142. It should be noted that rotor stop 148 is hollow and thus open at the bottom to form a continuation of winding slot 134 through which the winding pin may pass to engage the winding tab 136.

[0041] With reference to Figs. 2 and 3, after the winding tab 136 is moved off of the rotor stop 148 and travels clockwise past the shuttle stop 162, the winding tab 136 engages the gas gage flag 128 and pushes it in the direction of arrow 164 in Fig. 3 against the urging of gas gage spring 152.

[0042] The winding pin continues to traverse slot 134 while pushing winding tab 136 and gas gage flag 128 until reaching a position that simulates the injection device 100 being partially filled with liquid medication. Alternatively, the winding pin may push the winding tab 136 and gas gage flag 128 to the distal end 166 of slot 134 to simulate the injection device 100 being fully filled with liquid medication.

[0043] As illustrated in Figs. 1 and 4A, the distal ends of each of the pair of flex arms 108a and 108b are provided with inward facing ratchet teeth 168a and 168b, respectively. When the push button 104 is in the raised position illustrated in Fig. 1 , the flex arms 108a and 108b flex so that the ratchet teeth 168a and 168b travel over the teeth 126 of the rotor insert 124 in a ratcheting fashion as the winding tab 136 and gas gage flag 128 move into the position illustrated in Fig.4A. The ratchet teeth 168a and 168b then engage the teeth 126 of the rotor insert 124 to hold the rotor 116 in the illustrated position against the urging of the dispense spring (142 in Fig. 3) and the gas gage spring (152 in Fig. 3). The injection device trainer 100 may then be lifted off of the transfer device trainer (as described below).

[0044] To activate the injection device trainer 100, and to simulate initiation of an injection, and thus the injection of liquid medication, the push button 104, and thus the button claw 106, is pushed down from the raised position illustrated in Fig. 1 to a depressed position so that the ratchet teeth 168a and 168b move down and off of the teeth 126 of the rotor insert 124. After this occurs, the ratchet teeth 168a and 168b move below the rotor insert 124, due to the inward urging of the flex arms 108a and 108b so that the push button is held in the lowered or depressed position. As a result, the rotor 116, and thus the winding tab 136 and the gas gage flag 128, move in the counterclockwise direction of arrow 172 in Fig. 4B under the urging of the dispense spring and the gas gage spring. This movement occurs until the flag shuttle 132 engages the shuttle stop 162, as illustrated in Fig. 4B, to simulate the end of the injection and thus the end of delivery of the liquid medication. At this point, the ratchet teeth 168a and 168b align with notches 176a and 176b of the rotor insert 124 so that the compressed coil spring under the push button (104 of Fig. 1 ) is free to return the push button 104 to the raised position illustrated in Fig. 1.

[0045] As this occurs the teeth 174 of the rotor gear 118 engage a damper 176 which slows the rotation of the rotor 116 in the counterclockwise direction as it travels from the position illustrated in Fig. 4A to the position illustrated in Fig. 4B.

[0046] After reaching the position of Fig. 4B, the dispense spring continues to rotate the rotor 116 counterclockwise until the winding tab 136 engages the rotor stop 148, as illustrated in Fig. 4C. At this point, lockout tabs 178a and 178b (shown in both Figs. 1 and 4C) of the rotor 116 are positioned behind the lower portions of the of the pair of flex arms 108a and 108b to block their outward movement over the rotor insert and thus prevent the push button 104 of Fig. 1from being pushed down so as to simulate a lock out (post injection) configuration of the injection device trainer.

[0047] Transfer Device Trainer

[0048] An exploded view of a reusable transfer device trainer, indicated in general at 200, suitable for use with the injection device trainer described above is provided in Fig. 5. As described in previously mentioned U.S. Patent Application Publication No. US 2023 / 0285243, the transfer device trainer includes a housing, indicated in general at 202, having a base, indicated in general at 204. The housing 202 includes a vial holding portion 206 and a simulated gas expansion portion 208.

[0049] As described in U.S. Patent Application Publication No. US 2023 / 0285243, the vial holder portion 206 houses a vial elevator shaft, indicated at 212 within which is received a vial elevator 214. The vial elevator 214 vertically slides within the vial elevator shaft 212 in a telescoping fashion between a raised or extended position and a lowered or retracted position. As further described in U.S. Patent Application Publication No. US 2023 / 0285243, a cam ring 216 rotatably surrounds the vial elevator shaft 212 and features camming surfaces 217 that are engaged by camming hooks 219 positioned on splines 221 of the vial elevator 214 when it is moved downwards within the vial elevator shaft 212. In use, an inverted vial passes through a vial opening 215 of the housing cover 202 and is inserted into the vial elevator 214. The vial is then pushed downwards so that the vial elevator 214 moves downwards in the elevator shaft 212 thereby rotating the cam ring 216 due to engagement of the camming surfaces 217 with the camming hooks 219. An access cap 218 removably covers an access port222 to provide access to the elevator vial elevator and cam ring mechanism if necessary.

[0050] The housing 202 further includes an injection device support surface 224 that, as explained in greater detail below, removably receives and supports the injection device trainer for simulated refilling of the injection device trainer with liquid medication from a vial inserted into the vial elevator 214. The injection device support surface is provided with winding pin slots 225a and 225b (Fig. 5).

[0051] The transfer device trainer is provided with a winder 226 that may be accessed and turned through a winder window 228 formed in the injection device support surface 224. As explained in greater detail below, a rotor spring, which may be a hairspring 232, is wound by turning the winder 226. Alternative types of springs may be used for the rotor spring in place of a hairspring including, but not limited to, elastomeric springs, flat springs, leaf springs, torsion springs, flat springs, other types of coil springs and gas springs.

[0052] The hairspring 232 is housed within a drum assembly, indicated in general at 234. The drum assembly includes a drum 233 and a pair of drivers 235a and 235b. Winding pins 236a and 236b are positioned upon the drivers 235a and 235b and engage and wind the injection device trainer discussed with reference to Figs. 1-4C when the drum assembly 234 is rotated by the hairspring 232 upon activation of the transfer device trainer by insertion of an inverted vial.

[0053] As further illustrated in Fig. 5, the transfer device trainer also includes a drum gear 238, a damper 242, a bearing 244, a latch 246, an adjustable cam wall 248 and a strap release 252, the functionality of each of which will be explained below.

[0054] The transfer device trainer is powered by the hairspring 232 of Fig. 5 to simulate filling of the injection device trainer. The hairspring is wound by the winder 226 of Figs. 5 and 6 to prepare the transfer device trainer for use. As illustrated in Fig. 6, where the winder is indicated in general at 226, the winder includes a winding stem 256 that attaches to the inner end (254 of Fig. 5) of the hairspring. As an example only, the bottom portion of the winding stem 256 may be provided with a notch 257 within which the inner end of the hairspring may be placed. The stem extends downwards from a winder wheel 258 that is provided with winding recesses 262 that are configured to receive a user’s fingertips during winding. The winder also includes a pair of ratchet arms 264a and 264b.

[0055] As described previously, a winder window 228 is formed in the formed in the injection device support surface 224 of housing 202. As illustrated in Fig. 6, where the injection device support surface 224 is shown as transparent, winding teeth 266 are formed on or in the underside of the support surface 224 and point circumferentially inward towards the winding window 228.

[0056] When assembled, the top portion of the winder wheel 258 is received in a rotatable fashion within the winding window 228 so that the winding recesses may be accessed by a user’s fingers from above the transfer device trainer. The winder ratchet arms 264a and 264b are configured to engage and lock with the winding teeth 266 when the winder wheel 258 is rotated counterclockwise (when viewed from above the transfer device trainer). The ratchet arms 264a and 264b, however, flex slightly to pass over the winding teeth 266 in a ratcheting fashion when the winder wheel 258 is turned in a clockwise direction (i.e. the direction of arrow 268 of Fig. 6).

[0057] With reference to Fig. 7, the drum 233 of the drum assembly includes a circumferential drum sidewall 272 that defines a rotor spring well within which the hairspring (232 of Fig. 5) is positioned. An outer end (274 in Fig. 5) of the hairspring 232 is secured within a slot 276 (Fig. 7) formed within the drum sidewall 272, such as by a fastener (not shown) that passes through fastener opening 278. As examples only, the fastener may be a screw or rivet.

[0058] The bottom of the rotor spring well of Fig. 7 includes a drum bushing opening defined by a bushing surface 282. A bushing, illustrated at 284 in Fig. 5, passes through the drum bushing opening and rotatably secures the drum 233 to the base 204 (Fig. 5) via a base bushing opening 286 (Fig. 286) that receives the bushing 244.

[0059] The drum 233 of Fig. 7 is provided with a pair of keys 287a and 287b that receive corresponding mounting tabs 289a and 289b (Fig. 6) of drum gear 238 so that the drum gear 238 (Fig. 6) is mounted upon the drum 233 (Fig. 7). The damper 242 of Fig. 6 features mounting holes 243 that receive mounting posts 245 that extend downward from the underside of the injection device support surface 224. As a result, the damper 242 is mounted to the underside of the support surface 224 in a position where it engages teeth 290 of the drum gear. The damper thereby limits the speed at which the drum gear 238, and thus the drum 233, may turn. Suitable damping devices are well known in the art.

[0060] The drum 233 of Fig. 7 is provided with a pair of driver mounting posts 288a and 288b. These posts are used to mount the drivers 235a and 235b of Figs. 5, 8A, 8B, 9A and 9B to the drum 233. More specifically, each driver includes a clevis 292a and 292b to which a driver platform 296a and 296b is mounted. Clevis 292a includes drum attachment openings 294a while clevis 292bincludes drum attachment openings 294b. The drum attachment openings 294a and 294b pivotally receive driver mounting posts 288a and 288b, respectively, as illustrated in Figs. 9A and 9B. As a result, with reference to Fig. 9B, the drivers 235a and 235b are free to pivot in the directions indicated by arrows 298a and 298b with respect to the drum 233.

[0061] As illustrated in Figs. 8A-9B, the top of driver platform 296a has winding pin 236a mounted thereto while the top of driver platform 296b has winding pin 236b mounted thereto. As illustrated in Figs. 8A and 8B, a latch interface surface 302a extends downward from the driver platform 296a while, as illustrated in Figs. 9A and 9B, a latch interface surface 302b similarly extends downward from the driver platform 296b. As illustrated in Figs. 8A and 8B, a strap release actuator 304a extends radially outwards from the driver platform 296a while, as illustrated in Figs. 9A and 9B, a strap release actuator 304b similarly extends radially outwards from the driver platform 296b. As illustrated in Figs. 8A and 8B, a fixed cam follower 306a and an adjustable cam follower 308a are rotatably mounted to the underside of driver platform 296a while, as illustrated in Figs. 9A and 9B, a fixed cam follower 306b and an adjustable cam follower 308b are rotatably mounted to the underside of the driver platform 296b.

[0062] As illustrated in Fig. 10, the base 204 of the housing of the transfer device trainer is provided with a fixed cam wall 312 and an adjustable cam wall 248. The adjustable cam wall 248 is provided with cam wall fastener openings 316 while the base is provided with a series of corresponding base fastener openings 318. The position of the adjustable cam wall 314 may be adjusted along the base in the directions of arrows 322 and then secured in the selected position by fasteners (not shown) passing through the cam wall fastener openings 316 andthe base fastener openings corresponding to the selected adjustable cam wall position. As an example only, the fasteners may be screws.

[0063] A perspective view of the assembled transfer device trainer 200 with the housing 202 (Figs. 5 and 6) omitted is presented in Fig. 11 . The rotor spring (a hairspring in the illustrated embodiment) 232 of Fig. 5 is coiled / preloaded and positioned within the drum 233 with the winding stem 256 of Fig. 6 of the winder extending down into the rotor spring well of the drum. As explained previously, with reference to Fig. 6, to hold a preload on the rotor spring, the winder 226 has ratchet arms 264a and 264b that interface with the winding teeth 266 on underside of the injection device support surface 224 of the housing 202. The winder 226 must be rotated a number of times to ensure the appropriate preload is applied.

[0064] The drum gear 238 is mounted to the drum 233 in the manner described previously. Once the system is preloaded, and actuated, the drum gear interfaces with the damper (242 of Fig. 6) to ensure that the actuation does not happen too fast.

[0065] Returning to Fig. 11 , the drum 233 holds the energy in the rotor spring and translates that into rotary motion for the drivers 235a and 235b.

[0066] As will now be explained, the drivers 235a and 235b translate the rotor spring energy into the injection device trainer described with respect to Figs. 1-4C through the driver pins 236a and 236b.

[0067] As illustrated in Figs. 9B and 11 , the fixed cam followers 306a and 306b of drivers 235a and 235b, respectively, are positioned to traverse the top of the fixed cam wall 312 as the drum 233 rotates within the transfer device trainer. Movable cam followers 308a and 308b similarly traverse the top of the adjustablecam wall 248 as the drum 233 rotates. A pair of driver leaf springs, one of which is illustrated at 324 in Fig. 9B, ensures that both drivers 235a and 235b are biased onto the top surfaces of the fixed cam wall 312 and the adjustable cam wall 248.

[0068] The profiles of the fixed cam wall 312 and adjustable cam wall 248 therefore cause the driver pins 236a and 236b to raise and lower as the drum 233 rotates within the transfer device trainer. The fixed cam wall 312 sets the minimum injection device trainer preload. The adjustable cam wall 248 can be positioned (such as at the time of assembly) to configure the system to simulate partial fill or full fill of the injection device trainer.

[0069] With reference to Figs. 11 and 12, drivers 235a and 235b interface with the latch, indicated in general at 246, to initiate and stop rotation of the drivers. More specifically, as described previously with reference to Figs. 8A-9B, the drivers 235a and 235b include latch interface surfaces 302a and 302b. With reference to Fig. 12, the latch 246 includes a latch hook 332, latch stop 334 and a latch return spring 336. The latch 246 also includes a proximal end 338 that is pivotally mounted to the base 204 (also shown in Fig. 5).

[0070] With reference to Figs. 11 and 12 the cam ring 216 is provided with a cam ring finger 342. The cam ring finger 342 is engaged by the latch hook 332 so that the latch 246 is held in the position shown in Figs. 11 and 12 under the urging of latch return spring 336, which engages the inside surface of the housing (202 of Fig. 5). With reference to Fig. 12, when the latch 246 is in this position, the latch stop 334 of the latch 246 engages the latch interface surface 302a of the driver 235a so that rotation of the driver (by the wound hairspring 232 of Fig. 5) is prevented.

[0071] As explained previously, when an inverted vial is placed in the vial elevator 214 and pushed down, and the vial elevator moves down in response, a torsion is induced on the cam ring 216 so that it rotates in the counterclockwise direction. This causes the latch 246 to be pulled in the direction of arrow 344. As a result, the latch stop 334 of the latch 246 is pulled off of the latch interface surface 302a of the driver 235a so that rotation of the driver (by the wound hairspring 232 of Fig. 5) is initiated in the clockwise direction.

[0072] When the injection device trainer 100 is in the configuration illustrated in Fig. 4C, it is positioned upon the injection device support surface 224 (Fig. 5) of the housing 202 for simulated refilling. With reference to Fig. 11 , the adjustable cam wall 248 and fixed cam wall 312 are positioned on the base 204 such that the winding pin 236b of driver 235b is raised to pass through the winding pin slots 225a and 225b (Fig. 5) and engage the winding tab 136 (Fig. 4C) on the side abutting rotor stop 148 (this being possible by the rotor stop being hollow and open at the bottom). The driver 235b is raised away from the surface of base 204 due to travel of cam followers 308b and 306b up and along the cam walls 248 and 312, respectively, as the driver 235b moves in the clockwise direction.

[0073] As described previously with reference to Figs. 2 and 3, after the winding tab 136 is moved off of the rotor stop 148 by winding pin 236b of driver 235b, and travels clockwise past the shuttle stop 162, the winding tab 136 pushes the gas gage flag 128 in the direction of arrow 164 in Fig. 3 against the urging of gas gage spring 152.

[0074] The winding pin 236b continues to traverse slot 134 (Fig. 3) while pushing winding tab 136 and gas gage flag 128. The adjustable cam wall 248(Figs. 10 and 11 ) may be positioned to increase the combined length of the camwalls 248 and 312 so that the winding pin 236b of the driver pushes the winding tab 136 and gas gage flag 128 to the distal end 166 of slot 134 to simulate the injection device 100 being fully filled with liquid medication. Alternatively, the adjustable cam wall 248 may be positioned so that the combined length of the cam walls 248 and 312 is shortened so that the winding pin 236b pushes the winding tab 136 and gas gage flag 128 to a position that simulates the injection device 100 being partially filled with liquid medication (an example of which is presented in Fig. 4A).

[0075] Returning to Fig. 11 , after the cam followers 308b and 306b travel off of the cam walls 248 and 312 of the transfer device trainer 200, the driver 235b is lowered so that the strap release actuator 304b engages a toggle surface 348 of strap release 252 causing it to rotate inwards (towards the center of base 204). This causes a strap that secures the injection device to the injection device support surface of the transfer device trainer to be released. This strap is explained in greater detail in U.S. Patent Application Publication No. US 2023 / 0285243, referenced previously.

[0076] The drivers continue to rotate in the clockwise position until driver 235b is stopped by the latch 246 in the position of driver 235a in Fig. 11 . More specifically, after cam finger 342 has disengaged from the latch hook 332, and under the urging of latch return spring 336, the latch 246 is returned to the position illustrated in Figs. 11 and 12 so that the latch stop 334 of the latch 246 engages the latch interface surface 302b of the driver 235b. Driver 235a is then in the position of driver 235b in Fig. 11. As a result, a half rotation of the drivers equals one simulated refill, or partial refill, of the injection device trainer by the transfer device trainer.

[0077] A torsion spring (not shown) is configured to urge the cam ring 116 in the clockwise direction. Furthermore, the vial elevator 214 and cam ring 216 are configured so that the vial elevator releases the cam ring when the inverted vial is fully lowered or seated with transfer device trainer. This occurs by the camming hooks 219 of the vial elevator traveling off the lower ends of the cam surfaces 217 of the cam ring 216. When this occurs, the cam finger 342 rotates back into the position illustrated in Figs. 11 and 12 and in engagement with the latch hook 332, thus resetting the transfer device trainer.

[0078] In a first alternative embodiment illustrated in Fig. 13, rotation of the drivers is initiated using the first latch 246 as described above with reference to Figs. 11 and 12. In the embodiment of Fig. 13, however, a second latch, indicated in general at 252, features a driver stop end 254 and a cam finger end 256 and is pivotally mounted at 258. The second latch is urged by a spring (not shown) into the position illustrated in Fig. 13. As a result, the driver stop end 254 engages the latch interface surface 302b of driver 235b (or latch interface surface 302a of driver 235a) near the end of rotation as illustrated in Fig. 13. When the cam finger 342 rotates clockwise from the position shown in Fig. 13, it contacts the cam finger end 256 of the second latch so that the second latch pivots at 258 and driver stop end 254 releases the driver so that it continues rotation in the clockwise direction until engaging the latch 246 in the manner illustrated in Fig.12. As a result, when the inverted vial is removed from the vial elevator, the first latch 246 returns to the starting position and second latch 252 is released, and the drivers rotate an additional ~60 degrees to return to start position.

[0079] In a second alternative embodiment illustrated in Fig. 14, a pin 362 is positioned on cam finger 342 and traverses a slot 364 formed in a single latch366. The latch 366 has a first stop surface 368 and a second stop surface 372. The first stop surface engages the latch interface surface 302b of driver 235b (or latch interface surface 302a of driver 235a) prior to vial insertion into the elevator. After the vial is inserted and the cam finger 342 rotates counterclockwise, as illustrated in Fig. 14, the latch 366 rotates so that the driver is released. Stop surface 372 engages the latch interface surface 302b of driver 235b (or latch interface surface 302a of driver 235a) near the end of rotation as illustrated in Fig.14. When the cam finger 342 rotates clockwise from the position shown in Fig.14, it traverses slot 364 so that the latch pivots clockwise at 374. As a result, stop surface 372 releases the driver so that it continues rotation in the clockwise direction until engaging the stop surface 368.

[0080] Although the present subject matter is described herein with reference to specific structures, methods and examples, this is for purposes of illustration only, and it is understood that the present subject matter is applicable to a large range of devices and systems that may differ in particular configuration and appearance while still employing this subject matter.

Claims

CLAIMSWhat is claimed is:1 . A reusable injection device trainer comprising: a. an injection device housing. b. a push button mounted within the injection device housing and movable between a raised position and a lowered position; c. a push button spring urging the push button towards the raised position; d. a button claw including a pair of flex arms configured to move with the push button between the raised and lowered positions, said pair of flex arms including ratchet teeth positioned at distal ends of the flex arms; e. a rotor rotatably mounted within the injection device housing, said rotor including a winding tab, a rotor gear having rotor gear teeth and a rotor insert having rotor insert teeth, said rotor gear and said rotor insert concentrically mounted; f. said rotor insert teeth configured to be engaged by the ratchet teeth of the flex arms when the push button is in the raised position and the rotor is turned in a first direction and said rotor insert teeth and said ratchet teeth configured to be disengaged when the push button is in the lowered position or the rotor is turned in a second direction; g. said injection device housing including a winding slot through which the winding tab may be accessed;h. a rotor spring urging the rotor towards a prefill or a post-injection position; i. an injection device damper configured to engage the rotor gear teeth.

2. The injection device trainer of claim 1 wherein the pair of flex arms are mounted within an interior of the push button.

3. The injection device trainer of claim 1 wherein the rotor further includes a rotor cylinder having an exterior surface upon which the rotor gear and the winding tab are mounted.

4. The injection device trainer of claim 3 wherein the rotor spring iselastomeric and has a first end attached to the rotor cylinder and a second end attached to the injection device housing.

5. The injection device trainer of claim 1 further comprising a gas gage flag sidably mounted within the injection device housing and configured to be moved by the winding tab when the winding tab moves away from the prefill or the postinjection position.

6. The injection device trainer of claim 1 further comprising a gas gage spring having a first end connected to the rotor and a second end engaging the gas gage flag and urging the gas gage flag towards the winding tab.

7. The injection device trainer of claim 1 wherein the injection device housing is disk-shaped and the winding slot is arcuate.

8. The injection device trainer of claim 1 wherein the push button spring is a compression coil spring.

9. The injection device trainer of claim 1 wherein the rotor gear teeth face radially outwards and the rotor insert is mounted concentrically within the rotor gear.

10. The injection device trainer of claim 9 wherein said rotor insert teeth face radially outwards and the rotor gear is positioned between the flex arms with the ratchet teeth opposing the rotor insert teeth.11 .The injection device trainer of claim 1 wherein said rotor insert teeth face radially outwards and the rotor gear is positioned between the flex arms with the ratchet teeth opposing the rotor insert teeth.

12. A reusable transfer device trainer comprising: a. a transfer device housing including a base and an injection device mounting surface featuring a winding pin slot; b. a vial elevator positioned within the transfer device housing configured to receive a vial, said vial elevator including a camming hook;c. a vial elevator shaft within which the vial elevator moves between an extended position and a retracted position; d. a cam ring rotatably positioned around the vial elevator, said cam ring including a camming surface configured to be traversed by the camming hook as the vial elevator moves from the extended position to the retracted position whereby the cam ring rotates in a cam ring actuation direction, said cam ring including a cam ring finger; e. a drum assembly including: i. a drum rotatably mounted within the transfer device housing; ii. a driver pivotally attached to the drum, said driver including a latch interface surface, a top side to which a winding pin is attached and a bottom side to which a cam follower is attached; f. a winder mounted to the housing in a ratcheting manner so as to be rotatable with respect to the housing when turned in a first direction, but to engage the housing when urged in a second direction; g. a rotor spring connected between the winder and the drum, said rotor spring urging the drum assembly to rotate in a drum actuation direction; h. a latch pivotably mounted to the base and including a latch stop, said latch configured to rotate between a first latch position, where the latch stop engages the latch interface surface thereby preventing rotation of the drum assembly in the drum actuation direction, and a second latch position, where the latch stop disengages from the latch interface surface of the driver, when the cam ring rotates in acam ring actuation direction so that the drum assembly may rotate in the drum actuation direction; i. a cam wall mounted on the base, said cam wall having a top surface and positioned so that the cam follower of the driver traverses the cam wall top surface as the drum assembly rotates in the drum actuation direction so that the winding pin is raised away from the base and passes through and traverses the winding slot of the injection device mounting surface.

13. The transfer device trainer of claim 12 wherein the driver is a first driver and further comprising a second driver pivotally mounted to the drum, said second driver including a second latch interface surface, a second driver top side to which a second winding pin is attached and a second driver bottom side to which a second cam follower is attached.

14. The transfer device of claim 13 wherein the first and second drivers are respectively pivotally secured to the drum by a first clevis and a second clevis.

15. The transfer device trainer of claim 12 wherein the winder includes a pair of ratchet arms and the housing is provided with corresponding winding teeth over which the ratchet arms past when the winder is turned in the first direction and that the ratchet arms engage when the winder is urged in the second direction.

16. The transfer device trainer of claim 14 wherein the transfer device housingincludes a winder window and wherein the winder includes a winder wheel to which the pair of ratchet arms are attached and a stem to which the spring rotor is attached, said winder wheel positioned within the transfer device housing and accessible through the winder window.

17. The transfer device trainer of claim 15 wherein the winder window is positioned within the injection device support surface.

18. The transfer device of claim 12 further comprising a drum damper and wherein the drum assembly further includes a drum gear configured to engage the drum damper when the drum rotates in the drum actuation direction.

19. The transfer device of claim 12 wherein the cam wall is a fixed cam wall that is attached to the base in a fixed manner and further comprising and adjustable cam wall having an adjustable cam wall top surface, where the adjustable cam wall may be attached to the base in multiple alternative positions, and wherein the cam wall follower is a fixed cam follower and further comprising an adjustable cam follower mounted to the underside of the driver, where the fixed cam follower of the driver traverses the fixed cam wall top surface and the adjustable cam follower of the driver traverses the adjustable cam wall top surface as the drum assembly rotates in the drum actuation direction.

20. The transfer device trainer of claim 12 wherein the drum assembly is rotatably supported on the base by a bearing.21 . The transfer device trainer of claim 12 wherein the rotor spring is a hairspring.

22. The transfer device training of claim 20 wherein the winder includes a stem to which the hairspring is attached and the drum includes a drum sidewall that defines a rotor spring well within which the hairspring is positioned.

23. The transfer device trainer of claim 12 wherein the winder includes a stem to which the rotor spring is attached and the drum includes a drum sidewall that defines a rotor spring well within which the rotor spring is positioned.

24. The transfer device trainer of claim 12 wherein the latch includes a latch hook and a latch return spring wherein said latch hook is configured to engage the cam finger and rotate the latch to a position where the latch stop disengages from the latch interface surface of the driver when the cam ring rotates in a cam ring actuation direction so that the drum assembly may rotate in the drum actuation direction.

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