Injection and transfer device trainers

Abstract

Reusable training versions of injection and transfer 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 / 637,666, 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 reusable 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 transfer device trainer mechanism includes a vial elevator including a camming hook and a vial elevator shaft within which the vial elevator moves between an extended position and a retracted position. 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 also includes a belt gripping surface. A winding assembly includes a center timing shaft featuring a winding sheave, a clock spring having an inner end connected to the center timing shaft and an outer end, a winding hub connected to the outer end of the clock spring, where the winding hub includes a transfer device winding fitting, and a damper gear secured to the winding hub. A transfer device damper operatively engages the damper gear. A drive belt engages the belt gripping surface of the cam ring and the winding sheave of the center timing shaft so that when the cam ring rotates, the center timing shaft rotates.

[0007] In another aspect, a winding assembly includes a center timing shaft featuring a winding sheave, a clock spring having an inner end connected to thecenter timing shaft and an outer end, a winding hub connected to the outer end of the clock spring, where the winding hub includes a transfer device winding fitting, and a damper gear secured to the winding hub.

[0008] In another aspect, a reusable transfer device trainer includes a transfer device housing including an injection device mounting surface. A vial elevator is positioned within the transfer device housing and receives a vial. The vial elevator includes a camming hook. The 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 also includes a belt gripping surface. A winding assembly also includes a center timing shaft featuring a timing shaft recess having a timing shaft post positioned therein and a winding sheave. A clock spring assembly includes a clock spring positioned within a clock spring collar. The clock spring has an outer end attached to the clock spring collar and an inner end. A winding hub includes a transfer device winding fitting and a skirt portion defining a winding hub recess. The injection device mounting surface includes a mounting surface opening corresponding to the transfer device winding fitting. The clock spring collar is positioned within the winding hub recess and is secured to the winding hub skirt portion with the winding hub skirt portion positioned within the timing shaft recess with the inner end of the clock spring connected to the timing shaft post. A damper gear is secured to the winding hub. A transfer device damper is operatively connected to the damper gear. A drive belt engages thebelt gripping surface of the cam ring and the winding sheave of the center timing shaft so that when the cam ring rotates, the center timing shaft rotates.

[0009] In another aspect, a mechanism for simulating an injection includes a push button spring urging the push button towards the raised position. A button claw includes a first flex arm and a second flex arm that move with the push button between the raised and lowered positions. The first flex arm includes a first locking tab and the second flex arm includes a second locking tab. A rotor is rotatably mounted within the injection device housing and is movable between a first rotor position and a second rotor position. The rotor includes a first undercut, a second undercut and a rotor gear having rotor gear teeth. A rotor spring urges the rotor towards the second rotor position. A ratchet gear has a central opening and at least one ratchet tab extending into the central opening. The rotor gear is positioned within the central opening of the ratchet gear with the rotor gear teeth engaging the at least one ratchet tab so that the rotor gear may rotate only in a direction against the urging of the rotor spring with respect to the ratchet gear. A latch is configured to releasably engage the ratchet gear so as to prevent rotation of the ratchet gear. The first and second undercuts of the rotor are engaged by the first and second locking tabs of the flex arms against the urging of the push button spring when the push button is moved from the raised position to the lowered position and the rotor is in the first rotor position. The first and second undercuts release the first and second locking tabs of the flex arms when the rotor is rotated into the second rotor position so that the push button is moved into the raised position by the push button spring. An injection device damper operatively engages the rotor gear teeth. A winding shaft is connected to the rotor so that the rotor turns with the winding shaft. An injection device winding fitting is connectedto the winding shaft. The injection device housing includes an injection device winding fitting opening corresponding to the injection device winding fitting.

[0010] In another 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 first flex arm and a second flex arm configured to move with the push button between the raised and lowered positions. The first flex arm includes a first locking tab and said second flex arm includes a second locking tab. A rotor is rotatably mounted within the injection device housing and movable between a first rotor position and a second rotor position. The rotor includes a first undercut, a second undercut and a rotor gear having rotor gear teeth. A rotor spring urges the rotor towards the second rotor position. A ratchet gear has a central opening and at least one ratchet tab extending into the central opening. The rotor gear is positioned within the central opening of the ratchet gear with the rotor gear teeth engaging the at least one ratchet tab so that the rotor gear may rotate only in a direction against the urging of the rotor spring with respect to the ratchet gear. A latch is positioned within the housing and releasably engages the ratchet gear so as to prevent rotation of the ratchet gear. The first and second undercuts of the rotor are engaged by the first and second locking tabs of the flex arms against the urging of the push button spring when the push button is moved from the raised position to the lowered position and the rotor is in the first rotor position. The first and second undercuts release the first and second locking tabs of the flex arms when the rotor is moved into the second rotor position so that the push button is moved into the raised position by the push button spring. An injection devicedamper operatively engaging the rotor gear teeth. A winding shaft is connected to the rotor so that the rotor turns with the winding shaft. An injection device winding fitting is connected to the winding shaft and the injection device housing includes an injection device winding fitting opening corresponding to the injection device winding fitting.

[0011] In another aspect, a transfer device and injection device training system features a transfer device trainer including a transfer device housing including an injection device mounting surface. A vial elevator is positioned within the transfer device housing and receives a vial. The vial elevator includes a camming hook. The 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 also includes a belt gripping surface. A winding assembly also includes a center timing shaft featuring a timing shaft recess having a timing shaft post positioned therein and a winding sheave. A clock spring assembly includes a clock spring positioned within a clock spring collar. The clock spring has an outer end attached to the clock spring collar and an inner end. A winding hub includes a transfer device winding fitting and a skirt portion defining a winding hub recess. The injection device mounting surface includes a mounting surface opening corresponding to the transfer device winding fitting. The clock spring collar is positioned within the winding hub recess and is secured to the winding hub skirt portion with the winding hub skirt portion positioned within the timing shaft recess with the inner end of the clock spring connected to the timingshaft post. A damper gear is secured to the winding hub. A transfer device damper is operatively connected to the damper gear. A drive belt engages the belt gripping surface of the cam ring and the winding sheave of the center timing shaft so that when the cam ring rotates, the center timing shaft rotates. An injection device trainer is positioned on the injection device mounting surface of the transfer device trainer. The 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 first flex arm and a second flex arm configured to move with the push button between the raised and lowered positions. The first flex arm includes a first locking tab and said second flex arm includes a second locking tab. A rotor is rotatably mounted within the injection device housing and movable between a first rotor position and a second rotor position. The rotor includes a first undercut, a second undercut and a rotor gear having rotor gear teeth. A rotor spring urges the rotor towards the second rotor position. A ratchet gear has a central opening and at least one ratchet tab extending into the central opening. The rotor gear is positioned within the central opening of the ratchet gear with the rotor gear teeth engaging the at least one ratchet tab so that the rotor gear may rotate only in a direction against the urging of the rotor spring with respect to the ratchet gear. A latch is positioned within the housing and releasably engages the ratchet gear so as to prevent rotation of the ratchet gear. The first and second undercuts of the rotor are engaged by the first and second locking tabs of the flex arms against the urging of the push button spring when the push button is moved from the raised position to the lowered position and the rotor is in the first rotor position. The first and secondundercuts release the first and second locking tabs of the flex arms when the rotor is moved into the second rotor position so that the push button is moved into the raised position by the push button spring. An injection device damper operatively engaging the rotor gear teeth. A winding shaft is connected to the rotor so that the rotor turns with the winding shaft. An injection device winding fitting is connected to the winding shaft and the injection device housing includes an injection device winding fitting opening corresponding to the injection device winding fitting. The injection device winding fitting engages the transfer device winding fitting.BRIEF DESCRIPTION OF DRAWINGS

[0012] Fig. 1 is a perspective view of an embodiment of the injection device trainer of the disclosure.

[0013] Fig. 2 is a second perspective view of the injection device trainer of Fig. 1.

[0014] Fig. 3 is an exploded perspective view of the injection device trainer of Figs. 1 and 2.

[0015] Fig. 4 is an enlarged exploded view of the vial elevator, vial elevator shaft and cam ring of the injection trainer device of Fig. 3.

[0016] Fig. 5 is an enlarged second perspective view of the vial elevator shaft of Fig. 4.

[0017] Fig. 6 is an enlarged second perspective view of the vial elevator of Fig. 4.

[0018] Fig. 7 is an enlarged perspective view of the elevator locking mechanism of Fig. 3.

[0019] Fig. 8 is an enlarged perspective view of a first locking shuttle of the elevator locking mechanism of Fig. 7.

[0020] Fig. 9 is an enlarged perspective view of a second locking shuttle of the elevator locking mechanism of Fig. 7.

[0021] Fig. 10 is an enlarged perspective view of the shuttle guides and elevator shaft base of Fig. 3.

[0022] Fig. 11 A is a perspective view of a reset tool for unlocking the elevator locking mechanism of Fig. 7.

[0023] Fig. 11 B is a perspective view of a base for packaging that includes a reset tool for unlocking the elevator locking mechanism of Fig. 7.

[0024] Fig. 12 is a bottom perspective view of the transfer device of Figs. 1 and 2 with the housing base removed showing use of the reset tool of Fig. 11 A being used to unlock the elevator locking mechanism of Fig. 7.

[0025] Fig. 13 is a bottom perspective view of the transfer device of Figs. 1 and 2 with the housing base removed.

[0026] Fig. 14 is a top perspective view of the transfer device of Figs. 1 and 2 with the top portion of the housing removed.

[0027] Fig. 15 is an enlarged exploded top perspective view of the winding assembly of the transfer device of Fig. 14.

[0028] Fig. 16 is an enlarged exploded bottom perspective view of the center timing shaft, the clock spring assembly and the winding hub of the winding assembly of the transfer device of Figs. 14 and 15.

[0029] Fig. 17 is a bottom perspective view of the transfer device of Figs. 1 and 2 with the housing shown as transparent with an injection device trainer positioned thereon.

[0030] Fig. 18 is an enlarged perspective view of the latch release cam of Fig.17.

[0031] Fig. 19 is a perspective view of the injection device retainer strap ofFig. 17.

[0032] Fig. 20 is a top perspective view of an additional embodiment of the transfer device trainer of the disclosure with the top portion of the housing removed.

[0033] Fig. 21 is a top perspective view of the transfer device trainer of Fig. 20 with the single component winding hub and damper gear removed.

[0034] Fig. 22A is an enlarged perspective view of the spring pin assembly of the transfer device trainer of Figs. 20 and 21 .

[0035] Fig. 22B is a perspective view of the spring pin of Fig. 22A.

[0036] Fig. 23 is a bottom perspective view of the single component winding hub and damper gear of the transfer device trainer of Fig. 20.

[0037] Fig. 24 is a top perspective view of the transfer device of Figs. 1 and 2 with an injection device trainer positioned thereon.

[0038] Fig. 25 is a bottom perspective view of an embodiment of the injection device trainer of the disclosure.

[0039] Fig. 26 is an exploded perspective view of the injection device trainer of Figs. 25 and 26.

[0040] Fig. 27 is a bottom perspective view of the upper portion of the housing of the injection device trainer of Figs. 25 and 26.

[0041] Fig. 28 is a perspective view of the rotor, ratchet gear, push button claw, push button compression spring and winding shaft of the injection device trainer of Figs. 25 and 26.

[0042] Fig. 29 is a top perspective view of the injection device trainer of Figs. 25 and 26 with the top portion of the housing removed.

[0043] Fig. 30 is a second top perspective view of the injection device trainer of Fig. 29.

[0044] Fig. 31 is a bottom view of the rotor of Figs. 29 and 30.

[0045] Fig. 32 is a top perspective view of the ratchet gear, damper and bottom portion of the housing of the injection device trainer of Figs. 29 and 30.

[0046] Fig. 33 is a top perspective view of the rotor and push button claw of Figs. 28-30.

[0047] Fig. 34 is a top perspective view of an alternative embodiment of the injection device trainer of the disclosure.

[0048] Fig. 35 is an exploded view of the housing bottom portion, rotor, tissue tent bridge and tissue tent injection needle cover of the injection device trainer of Fig. 34.

[0049] Fig. 36 is a bottom perspective view of the components of Fig. 35 after assembly.

[0050] Fig. 37 is a bottom perspective view of the rotor of Figs. 35 and 36.

[0051] Fig. 38 is a top perspective view of the rotor of Fig. 37.

[0052] Fig. 39 is a top perspective view of the bottom portion of the housing with the assembled rotor and tissue tent bridge of Figs. 35 and 36 and a fill indicator ring installed.

[0053] Fig. 40 is a top perspective view of the assembled components of Fig. 39 with a ratchet gear also installed.

[0054] Fig. 41 is a top perspective view of a transfer device trainer that is compatible with the injection device trainer of Figs. 34-40.

[0055] Fig. 42 is an enlarged top perspective view of the winding hub and damper gear of the transfer device trainer of Fig. 41 including a transfer device winding fitting.DESCRIPTION

[0056] 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.

[0057] Commonly assigned U.S. Patent No. 11 ,571 ,361 to Bourelle et al., issued February 7, 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 airfrom the pressure chamber directed to the inverted vial to displace the injectable.As a result, the transfer devices are also single-use devices.

[0058] The vial may be a standard drug vial with a rigid container portion usually glass, open at one end and sealed by a pierceable 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.

[0059] It should be noted that “injectable fluid,” “injectable,” “drug,” “medicament”, medication and like terms are used interchangeably herein.

[0060] While the embodiments disclosed below use a single vial, alternative embodiments include transfer stations that may accommodate two or more vials.

[0061] Transfer Device Trainer

[0062] A transfer device trainer of the disclosure is indicated in general at 100 in Figs. 1 and 2. An exploded view of a transfer device trainer is provided in Fig.3. 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 102, and a base, indicated in general at 104 in Fig. 3, to which the housing is mounted. The housing 102 includes a vial holding portion 106 and a simulated gas expansion portion 108.

[0063] As described in U.S. Patent Application Publication No. US 2023 / 0285243, and illustrated in Figs. 1-3, the vial holder portion 106 houses a vial elevator shaft, indicated at 112, within which is received a vial elevator 114. The vial elevator 114 vertically slides within the vial elevator shaft 112 in atelescoping fashion between a raised or extended position (illustrated in Figs. 1 and 2) and a lowered or retracted position.

[0064] The vial elevator shaft 112 is mounted within the vial holder 106 of the housing in a fixed manner so that it doesn’t rotate therein. With reference to Fig.5, this is accomplished by inwardly extending hooks 113 formed on the bottom portion of the vial elevator shaft 112 that, with reference to Fig. 7, engage and lock into undercuts or recesses 109 formed within mounting posts 111 that extend upwardly from the vial elevator shaft base, indicated in general at 118 (in Fig. 7).

[0065] As further described in U.S. Patent Application Publication No. US 2023 / 0285243, and with reference to Figs. 3 and 4, a cam ring 116 rotatably surrounds the vial elevator shaft 112 and features camming surfaces 117 that are engaged by camming hooks 119 positioned on splines 121 of the vial elevator 114 when it is moved downwards within the vial elevator shaft 112.

[0066] In use, with reference to Figs. 1 and 2, an inverted vial 122 passes through a vial opening 115 of the vial holding portion 106 of the housing cover 102 and the vial neck portion is inserted into, and in engagement with, the vial elevator 114. The vial is then pushed downwards so that the vial elevator 114 moves downwards in the elevator shaft 112 (Figs. 3 and 4) thereby rotating the cam ring 116 due to engagement of the camming surfaces 117 with the vial elevator camming hooks 119. The cam ring 116 is only capable of rotating in one direction.

[0067] As illustrated in Fig. 4, each camming surface 117 is formed on an edge of a corresponding triangular camming member 101 . Each camming member 101 is provided with a recess 103 on the inward-facing or back side that defines an internal reset camming surface 105. The vial elevator camming hooks119 are horizontally spaced from one another so that as a camming hook 119 of the vial elevator 114 travels down a camming surface 117 of the cam ring 116, and the cam ring 116 rotates, at least one neighboring camming hook enters the recess 103 on the back side of the neighboring camming member 101 . As a result, the neighboring camming hook is positioned to engage an internal reset camming surface 105, and thus turn the cam ring, when the elevator 114 is pulled upwards to reset the device as described below.

[0068] The elevator 114 therefore acts on the cam ring cam surfaces 117 by camming it forward on the down stroke and flexing the cam ring 116 via the reset camming surfaces 105 on the up stroke. The Elevator cam hooks 119 alternate between acting on a cam surface, thus advancing the cam ring forward 30 degrees (as an example only), and passing behind a cam surface, thus allowing them to flex past the cam surface on the up-stroke and therefore ending up in a position which allows them to act on the cam surface in the subsequent use.

[0069] This properly positions at least one camming hook 119 at the top of a camming surface 117 so that the vial elevator 114 and cam ring 116 are properly aligned for the next training session or demonstration.

[0070] With reference to Figs. 1 and 2, the housing 102 further includes an injection device support surface 124 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 122 inserted into the vial elevator 114. The injection device support surface is provided with a transfer device winding fitting 125, the operation of which will be explained below. A pair of locator pins 126a and 126b extend upwards from the injection device support surface 124 and engage corresponding openings 127a and 127b (Fig. 21 )formed in the bottom of the injector to prevent the injector from spinning with respect to the transfer device when mounted to the injection device support surface 124.

[0071] With reference to Fig. 7, the elevator shaft base 118 is provided with an elevator locking mechanism to secure the vial elevator 114 in the fully retracted position after a vial has been inserted therein and pushed fully into the transfer device. The elevator locking mechanism includes a pair of locking shuttles 132a and 132b that are slidably positioned on the elevator shaft base 118 and forced radially outwards by a compression spring 134.

[0072] As illustrated in Figs. 8 and 9 locking shuttle 132a is provided with outward facing hook or undercut 136a, while locking shuttle 132b is provided with outward facing hook or undercut 136b. Locking shuttles 132a and 132b are further provided with horizontal posts 138a and 138b, respectively, which are received within the ends of the compression spring 134 as illustrated in Fig. 7. As illustrated in Fig. 10, the elevator shaft base 118 is provided with a pair of shuttle guides 142a and 142b that slidably receive the flanges 144a and 144b of locking shuttles 132a and 132b, respectively.

[0073] As illustrated in Fig. 6, the elevator is provided with inward extending locking hooks 148a and 148b. When the elevator (with a vial positioned therein) is pushed to the fully lowered or retracted position, locking hooks 148a and 148b engage the undercuts 136a and 136b (Figs. 7 and 9) of locking shuttles 132a and 132b (Figs. 7-9), locking the elevator and vial in place within the transfer device housing.

[0074] Once the elevator and vial (114 and 122 of Figs. 1 and 2, respectively) are locked in the fully retracted and inserted positions as described in the previousparagraph, an unlocking reset tool, such as the one indicated in general at 152 in Fig. 11 A, is required to unlock the two components for reset. As illustrated in Fig.11A, the reset tool includes a wedge-shaped tip 154. The tip 154 is sized to pass through an unlock opening 156 (illustrated in Figs. 7, 10 and 13) formed in the elevator shaft base 118. Insertion of the tip 154 (of Fig. 11 ) through the unlock opening (as illustrated in Fig. 12) results in the tip 154 engaging and traveling up inclined surfaces 158a and 158b of the locking shuttles 132a and 132b of Figs. 8 and 9 so that the locking shuttles slide radially inwards against the urging of compression spring 134 (of Fig. 7). This causes the undercuts 136a and 136b (Figs. 7 and 9) of locking shuttles 132a and 132b to disengage the locking hooks 148a and 148b (Fig. 6) of the elevator so that the elevator is unlocked.

[0075] It should be noted that the configuration of reset tool 152 of Figs. 11A and 12 is provided as an example only. As another example, with reference to Fig. 11 B, the tip 154 could be positioned on the bottom of the product packaging, such as a tray or a storage box bottom 155, so that the tip extends upwards to unlock the transfer device 100 automatically by placing it within or on the packaging, storage box or storage tray.

[0076] Once unlocked, the elevator 114 and vial 122 may be returned to the starting positions illustrated in Figs. 1 and 2. This may be accomplished by pulling upwards on the vial. As the vial rises from the fully inserted position, the vial elevator 114 is pulled upwards within the elevator shaft 112 of Figs. 3 and 4. As described previously, this causes the cam ring 116 to rotate back to a reset position that is properly aligned with regard to a camming hook 119 of the vial elevator 114.

[0077] As shown in Figs. 3, 4, 13 and 14, the cam ring 116 is provided with downward-extending arcuate belt gripping surfaces 162. As illustrated in Figs. 13 and 14, the belt gripping surfaces of the cam ring 116 are engaged by a drive belt 164. Drive belt 164 further engages a winding sheave 166 of a winding assembly, indicated in general at 170 in Figs. 13 and 14. An exploded view of winding assembly 170 is presented in Fig. 15.

[0078] As illustrated in Figs. 13-16, the winding assembly 170 includes a center timing shaft 172, the bottom of which is provided with the previously mentioned winding sheave 166. As illustrated in Fig. 15, the center timing shaft 172 defines a center timing shaft recess 174 within which is positioned a timing shaft post 176.

[0079] A clock spring assembly 177 includes a clock spring 178 and a clock spring collar 182. The clock spring 178 is positioned within the clock spring collar 182 with the outer end of the clock spring secured to the collar 182. The clock spring collar 182 is positioned within the center timing shaft recess 174 and an inner end of the clock spring 178 is connected to the timing shaft post 176 via a connector 184.

[0080] A winding hub, indicated in general at 186 in Figs. 15 and 16, includes the previously mentioned transfer device winding fitting 125 (Fig. 15) and a downward extending skirt portion 188. The skirt portion 188 defines a winding hub recess, indicated at 192 in Fig. 16 and is provided with screw openings 194.Screws (not shown) are received by and pass through the screw openings 194 so as to engage and secure the collar 182 of the clock spring assembly within the winding hub recess 192 (Fig. 16). The downward extending skirt portion 188 of the winding hub has a diameter that permits it to be received within the centertiming shaft recess 174. The heads of the screws that pass through the openings 194 of the winding hub may be accessed (such as by a screwdriver) through slots 196 formed through the sidewall of the center timing shaft 172.

[0081] A damper gear, indicated in general at 198 in Fig. 15, features a central opening 202 that is provided with notches 204 that face radially inwards. These notches are engaged by protrusions 206 formed on the winding hub so 186 the damper gear 198 turns with the winding hub 186.

[0082] As noted previously with reference to Figs. 13 and 14, a drive belt 164 engages the winding sheave 166 of the center timing shaft 172 of the winding assembly 170. As a result, as the downward-extending arcuate belt gripping surfaces 162 of the cam ring 116 are turned in the clockwise direction when viewed from the top of the device (arrow 207 in Figs. 13 and 14) due to insertion of a vial into the corresponding vial elevator, the center timing shaft 172 of the winding assembly 170 is also turned clockwise when viewed from the top of the device (arrow 209 in Figs. 13 and 14). As an example only, the rotation of the center timing shaft 172 may be approximately thirty degrees. With reference to Figs. 15 and 16, this causes the timing shaft post 176 of the center timing shaft 172 to turn relative to the collar 182 of the clock spring assembly 177 and the clock spring 178 to be partially and temporarily wound.

[0083] As the wound clock spring 178 (Figs. 15 and 16) unwinds, with reference to Fig. 14, the winding hub 186 and damper gear 198 turn in the direction of arrow 209. As a result, transfer device winding fitting 125 also rotates in the direction of arrow 209. As the damper gear 198 rotates, dampers 212a and 212b engage teeth 214 positioned on the outer perimeter of the damper gear 198. The dampers reduce the speed that the damper gear 198 turns in the direction ofarrow 209 as the clock spring 178 of Figs. 15 and 16 unwinds. The number of dampers may be varied from the two dampers shown.

[0084] With reference to Figs. 17 and 18, a latch release cam, indicated in general at 216, is rotationally mounted adjacent to the damper gear 198 and features a gear portion 218 that is engaged by the teeth 214 of the damper gear as it turns. As illustrated in Fig. 18, the latch release cam 216 also includes a ramp surface, indicated in general at 222, extending along a portion of the periphery of the latch release cam and having a first end portion 224 and a second end portion 226.

[0085] As illustrated in Figs. 1 , 17 and 20, the transfer device is provided with an injection device retaining strap 227. As illustrated in Figs. 1 and 19, the injection device retaining strap 227 includes a pair of hinge pins 228a and 228b by which a corresponding end of the strap is pivotally secured to the transfer device. As illustrated in Fig. 19, the opposite end of the strap 227 is provided with an inwardly extending latching member 230. The latching member 230 of Fig. 19 engages the first end portion 224 (Fig. 18) of the latch release cam 216 so that the strap 227 is secured in the positions illustrated in Figs. 1 , 17 and 20 whereby an injection device is secured to the transfer device as illustrated in Fig. 20.

[0086] With reference to Figs. 17 and 18, When the teeth 214 of the damper gear 198 rotate the latch release cam 216 via the gear portion 218 of the latch release cam, the latching member 230 (Fig. 19) of the strap 227 travels up the ramp portion 222 of the latch release cam from the first end 224 to the second end 226. When the latching member 230 travels off of the second end 226 of the latch release cam 216, the corresponding end of the strap 227 is released so that the strap may pivot or be pivoted via hinge pins 228a and 228b (Figs. 1 and 19)so that an injection device may be lifted off of, or otherwise removed from, the transfer device.

[0087] Upon completion of rotation of the damper gear 198, which corresponds to completion of a training session or demonstration for the transfer device, the latch release cam 216 is positioned so that the latching member 230 (Fig. 19) engages the first end 224 of the latch release cam when the injection device is repositioned on the transfer device and the strap 227 is pushed down into the position illustrated in Figs. 1 , 17 and 24.

[0088] In an alternative embodiment of the clock spring assembly, illustrated in Figs. 20 and 21 , the center timing shaft 172a is provided with a center post 176a that includes a slot 177 within which the inner end of the clock spring 178 is secured. Furthermore, as illustrated in Figs. 20 and 23, the winding hub 186 and damper gear 198 of Fig. 15 (corresponding to 186a and 198a in Figs. 20 and 23) have been combined into a single component winding hub and damper gear 199 having slots 201 a and 201 b. With reference to Fig. 23, the outer end of clock spring is secured via slot 197 to the inner surface of the winding hub 186a portion of the single component 199.

[0089] As illustrated in Fig. 20, slots 201a and 201 b received fasteners 203a and 203b by which the winding hub and damper gear 199 is mounted to the center timing shaft 172a. Fasteners 203a and 203b may be sized so as to slide within slots 201 a and 201 b to allow the center timing shaft 172a to turn a bit prior to engagement with, and turning of, the winding hub and damper gear 199. This simulates a delay in liquid medication flow from the transfer device to the injection device. Such a delay may occur, for example, due to pressurization and gas flow times required in the actual transfer device.

[0090] In the alternative embodiment of the transfer device trainer, with reference to Figs. 20 and 21 , a spring-loaded belt tensioner, indicated in general at 232, has also been added. The belt tensioner includes a pulley wheel 233 that is mounted to the distal end of arm 234. Arm 234 is pivotally mounted to the base 103 of the transfer device housing via fastener 235. With continued reference to Figs. 20 and 21 , a torsion spring 236 urges the arm 234 towards, and thus pulley wheel 233 into engagement with, the outer surface of belt 264 with sufficient force that slack in the belt is eliminated. Such a belt tensioner may also be provided to the embodiment of Figs. 3-17.

[0091] As further indicated in Figs. 20 and 21 , a spring pin assembly 237 has been mounted to base 103. As illustrated in Figs. 22A and 22B, the spring pin assembly 237 includes a pin 238 which is surrounded by and in engagement with a coil spring 239. As illustrated in Figs. 20, 21 and 22A, the pin 238 and coil spring 239 are mounted within a mounting member 241 which is secured to the base 103. The coil spring 239 engages the mounting member 241 so as to be urged towards the cam ring 116a.

[0092] As illustrated in Figs. 20 and 21 , cam ring 116a has been provided with a series of spaced beads 245 positioned around the perimeter of its bottom end. Beads 245 of the cam ring are engaged and traversed by the inward facing tip of the pin 238 (Figs. 22A and 22B) of the spring pin assembly 237 as a vial that is positioned within the vial elevator 114 is pushed down and the cam ring 116a turns in response. This provides a slight resistance as the vial and vial elevator 114 are pushed down into the fully lowered position, which simulates piercing of the vial stopper by vial spikes that are present in the non-training version of thetransfer device. Such spring pin arrangement and cam ring may also be provided to the embodiment of Figs. 3-17

[0093] On-Body Injection Device Trainer

[0094] An injection device trainer of the disclosure is indicated in general at 240 in Figs. 24 and 25. The injection device trainer 240 includes a housing having a top portion 242 and a bottom portion 244. As illustrated in Fig. 1 , the injection device trainer is provided with a push button 246 that is pushed to initiate a simulated injection. The push button is shown in the raised position in Fig. 1 .

[0095] The internal components of the injection device trainer 240 are illustrated in Fig. 26, where an exploded view is presented.

[0096] As illustrated in Fig. 26, the push button 246 is mounted within a socket 256 formed within the top portion 242 of the housing so that the button may move between the raised position illustrated in Fig. 24 and a depressed or lowered position, where such movement simulates activation of the injection device.

[0097] As illustrated in Fig. 27, where the underside of the top portion 242 of the housing is visible, socket 256 is provided with a pair of opposing button tracks 258a and 258b. As illustrated in Fig. 26, the button 246 is provided with a guide tab 262 which is received by, and slides within, button track 258a. The button 246 also features a second guide tab, positioned on the side of the button opposite guide tab 262 and thus not visible in Fig. 26, which is similarly received by, and slides within, button track 258b of Fig. 27. An alternative number of guide tabs and corresponding button tracks may be used.

[0098] With reference to Fig. 26, the injection device trainer 100 includes a button claw, indicated in general at 248. The button claw features a pair of flex arms 252a and 252b joined by a bridge portion 254. An alternative number of flexarms may be used. The button 246 features an elongated slot 264 that receives flex arm 252a so that the flex arm is free to flex therein. A second elongated slot is provided on the hidden opposite side of button 246, and thus is not visible, and receives flex arm 252b in a similar fashion. The button claw may optionally be integrally molded or otherwise formed with the button as a single piece.

[0099] A compression spring, indicated at 266 in Figs. 26 and 28, features a top end which engages the bridge portion 254 of the button claw 248. The bottom of the compression spring 266 engages a rotor, indicated in general at 268, so that the button 246 is urged into the raised position illustrated in Fig. 24.

[0100] The rotor 268 is rotatably mounted to the bottom portion 244 of the housing. The rotor includes a rotor gear 272, a rotor cylinder 274 and a fill indicator 276. The rotor cylinder 274 includes a central recess 278 that receives the bottom end of the compression spring 266, as illustrated in Fig. 28.

[0101] A ratchet gear, indicated in general at 282 in Fig. 26, includes a central opening 284 into which extend ratchet tabs 286a-286d. The ratchet tabs are sized and angled so that when the rotor gear 272 (Fig. 26) is positioned within the ratchet gear central opening 284 (Fig. 26), in the manner illustrated in Fig. 28, the ratchet tabs engage the teeth of the rotor gear so that the rotor 268 may only turn in the direction of arrow 288 of Fig. 40 when the ratchet gear 272 is free to turn in the direction of arrow 288.

[0102] With reference to Figs. 26, 29 and 30, a latch, indicated in general at 292 features a slanted engagement surface 294 and latch teeth 296. The latch 292 is pivotally mounted to the bottom portion 244 of the housing by a pin 298 that engages opening 302 (Fig. 26) formed in the housing bottom portion. A torsion spring 304 has a central loop portion that receives the pin 298 and features a pairof arms, one of which engages the latch 292 on a side opposite of the engagement surface 294 with the remaining arm engaging an interior surface of housing bottom portion 244. As a result, as illustrated in Figs. 29 and 30, the latch 292 is urged into a position where the latch teeth 296 engage the exterior teeth 306 of the ratchet gear 282.

[0103] A rotor spring, which is preferably a tension spring and is indicated at 308 in Figs. 26, has a first end attached to the housing bottom portion via post 312 and a second end attached to the rotor via post 314 (shown disconnected in Figs. 29 and 30). Due to the ratchet tabs 286a-286d, the rotor gear may rotate only in a direction against the urging of the rotor spring with respect to the ratchet gear during winding of the injection device trainer.

[0104] A winding shaft, indicated at 316 in Figs. 26 and 28 includes a D- shaped lower portion 318 (Fig. 26) that is received within a keyed opening 322 (Fig. 31 ) that passes through the bottom of the rotor 268. As illustrated in Fig. 26, the lower portion 318 also passes through an opening 324 formed within the housing bottom portion 244, with the D-shaped lower portion 318 of the winding shaft extending out of the housing bottom portion being received within and secured to an injection device winding fitting 325, as illustrated in Fig. 25.

[0105] With reference to Figs. 26 and 32, a damper 326 is rotatably mounted to the bottom portion 244 of the injection device housing and is engaged by the teeth 306 of the ratchet gear 282 so as to limit the speed at which the ratchet gear may turn.

[0106] In operation, as illustrated in Fig. 24, the injection device trainer 240 is secured to the transfer device 100 via retaining strap 227 with the injection devicewinding fitting 325 (Fig. 25) in engagement with the transfer device winding fitting125 (Fig. 1 ).

[0107] With reference to Fig. 1 , and as described above, insertion of a vial into the transfer device results in the transfer device winding fitting 125 turning in a clockwise direct, as illustrated by arrow 327. As will be explained below, the injection device trainer is configured to use the turning transfer device winding fitting to simulate filling of the injection device with liquid medication and to prepare the injection device trainer to perform a simulated injection.

[0108] With reference to Fig. 25, winding fitting 325 of the injection device is turned in the direction of arrow 328 (Figs. 25 and 26) by the winding fitting of the transfer device. This causes the winding shaft 316 of Figs. 26 and 28 to also turn in the direction of arrow 328 (i.e. clockwise when viewed from the top of the injection device).

[0109] It is to be understood that the winding and unwinding directions of the transfer device winding fitting and the injection device winding fitting may be reversed in alternative embodiments of the devices and are in no way limiting.

[0110] As the winding shaft 316 turns, the rotor 268 also turns in the same direction (i.e. the direction of arrow 328 of Fig. 26) against the urging of tension spring 308. As the rotor rotates, the fill indicator 276, which is visible through a window formed in the upper portion 242 of the housing, rotates from a position indicating that the injection device is empty (simulated) to a position that the injection device is full or partially filled (simulated) with liquid medication. The dampers 212a and 212b (Fig. 14) of the transfer device regulate the speed at which the transfer device winding fitting 125 turns, and thus the speed at whichthe rotor 268 of the injection device turns thus simulating the timing that an actual fill of the injection device with liquid medication takes.

[0111] The ratchet gear 282 is held in a fixed position by latch 292 as the rotor 268 turns within the central opening 284 of the ratchet gear while the ratchets 286a-286d of the ratchet gear pass over the teeth of the rotor gear 272 of the rotor.

[0112] When the rotor 268 reaches the end of rotation (with the fill indicator 276 in a position indicating “full”), the tension spring 308 is extended but prevented from rotating the rotor back to its starting position due to engagement of the ratchets 286a-286d by the teeth of the rotor gear 272 of the rotor. Furthermore, when the fill indicator 276 of the injection device reaches the “full” position, the latch release cam 216 (Figs. 17 and 18) of the transfer device has rotated to a position corresponding to release of the injection device retaining strap 227. As a result, the injection device may be removed from the transfer device so that a simulated injection may be performed.

[0113] Operation of the injection device trainer 240 described thus far when simulating an injection will now be described.

[0114] With reference to Figs. 28 and 33, flex arms 252a and 252b have inwardly extending locking tabs 332a and 332b that rest on radially tapered ledges 334a and 334b formed in rotor cylinder 274 prior to the button of the injection device being depressed or pushed down to dispense.

[0115] When the injection device push button (246 in Fig. 24) is depressed or pushed down, the button claw 248 is also moves down (in the direction of arrow 336 of Figs. 24 and 29). As this occurs, the locking tabs 332a and 332b slide down and off the tapered ledges 334a and 334b as the flex arms 252a and 252bresi liently flex apart. As they continue to travel downwards in the direction of arrows 336, the flat top surfaces of locking tabs 332a and 332b engage undercuts 338a and 338b as the flex arms 252a and 252b snap back to their original position where they are closer together. As a result, the injection device push button (246 in Fig. 24) remains in the depressed position simulating the configuration of the injection device during an injection.

[0116] As illustrated in Figs. 29 and 30, the push button 246 is provided with a radially extending finger 342. Finger 342 is positioned so as to engage and traverse down the engagement surface 294 of the latch 292 as the locking tabs 332a and 332b (Figs. 28 and 33) move downward from ledges 334a and 334b of the rotor 268 and into engagement with rotor undercuts 338a and 338b.Returning to Figs. 29 and 30, as the finger 342 traverses down the engagement surface 294 of latch 292, the latch pivots about pin 298 and against the urging of torsion spring 394 so that the teeth 296 of the latch disengage from the teeth 306 of the ratchet gear. As a result, the rotor 268 is released and turned in the direction of arrow 344 as the tension spring 308 contracts.

[0117] As rotor 268 turns in the direction of arrow 344 of Figs. 29 and 30, damper 326 (Fig. 29) slows the rotor rotation due to the engagement of teeth 306 of the ratchet gear with the teeth of the damper 326. This slows the rotation of the rotor 268 and permits the movement of the fill indicator 276 from the “full” position to the “empty” position to approximate the movement that would occur if the injection device was dispensing liquid medication.

[0118] With reference to Figs. 28 and 33, as the fill indicator moves in to the “empty” position, the top surfaces of the locking tabs 332a and 332b move out from under the rotor undercuts 338a and 338b and into channels 346a and 346b.As a result, compression spring 266 is free to expand and push the button claw 248, and thus the push button 246 (Figs. 29 and 30) back up to the initial starting position illustrated in Fig. 25.

[0119] As illustrated in Figs. 28 and 33, flex arms 252a and 252b are provided with lockout members 348a and 348b which feature tapered outer surfaces 352a and 352b, respectively, and bottom stops 354a and 354b, respectively. As further illustrated in Figs. 28 and 33, the rotor 268 is provided with lockout blocks 356a and 356b, which oppose rotor channels 346a and 346b. As the button claw 248 (along with the injector push button 246) rises back to the original starting position of Fig. 21 , the tapered outer surfaces 352a and 352b of lockout members 348a and 348b pass between the inner surfaces of lockout blocks 356a and 356b so that the flex arms 252a and 252b are compressed slightly towards one another. After the tapered outer surfaces 352a and 352b of lockout members 348a and 348b pass over the lockout blocks 356a and 356b, the flex arms 252a and 252b spring back to their original, undeflected positions (illustrated in Figs. 28 and 33) with the rotor lockout blocks 356a and 356b positioned below the bottom stops 354a and 354b of the flex arm lockout members. As a result, the injection device push button 246 (Figs. 25, 29 and 30) is “locked out” and cannot be pushed down from the position illustrated in Fig. 25. This simulates the injection device configuration after an injection is given whereby the injection cannula (on the actual injection device) cannot be extended or deployed from the bottom of the injection device.

[0120] An alternative embodiment of the injection device trainer of the disclosure is indicated in general at 400 in Fig. 34. As will be explained below, the injection device trainer 400 provides an alternative injection device winding fitting(in place of the winding fitting 325 of Fig. 25) and a fill indicator with improved operational simulation (as compared to the fill indicator 276 of Figs. 26 and 28). With the exception of the components described below, the injection device trainer 400 of Fig. 34 features the same components and functionality as described above for the injection device trainer 240 (Figs. 24-26) with reference to Figs. 24-33.

[0121] As illustrated in Fig. 34, the injection device trainer 400 includes a housing having a top portion 401 and a bottom portion 402. As illustrated in Fig. 35, the bottom portion 402 of the housing includes a central opening 404 that, as described in greater detail below and illustrated in Fig. 36, receives a simulated tissue tent injection needle cover 406 and a winding disk 408 of a rotor, indicated in general at 412 in Figs. 35, 37 and 38.

[0122] With reference to Figs. 35 and 36, the tissue tent injection needle cover 406 is secured to the bottom portion 402 of the housing in a fixed fashion while the rotor 412 is secured to the bottom portion of the housing in a limited rotation fashion. As will be explained in greater detail below, both of the above are accomplished via a tissue tent bridge indicated in general at 414 in Fig. 35.

[0123] As illustrated in Figs. 37, 38 and 39 the rotor 412 includes a rotor gear 416 and a rotor cylinder 418. The rotor cylinder 418 includes a central recess 422 (Fig. 38) with a bottom boundary formed by the winding disk 408 of the rotor (Fig. 37). As illustrated in Fig. 38, the top edge of the central recess 422 is provided with a lip portion 424 that defines an undercut 426 (with an opposing undercut hidden from view in Fig. 38). As illustrated in Fig. 38, opposing tissue tent bridge channels 428a and 428b are also formed within the walls defining the central recess 422.

[0124] As illustrated in Fig. 35, the tissue tent bridge 414 includes a pair of arms 432a and 432b, where each is provided with bottom mounting posts 434a and 434b. During assembly, as illustrated in Fig. 39, the rotor 412 is positioned within the bottom portion 402 of the housing with, as illustrated in Fig. 36, the winding disk 408 positioned through the central opening of the bottom portion of the housing.

[0125] Next, with reference to Fig. 39, the arms 432a and 432b of the tissue tent bridge 414 are inserted through the corresponding tissue tent channels 428a and 428b of the rotor so that the tissue tent bridge 414 is positioned within the central recess of the rotor and, with reference to Fig. 36, the bottom mounting posts 434a and 434b (also shown in Fig. 35) of the arms of the tissue tent bridge in engagement with corresponding openings 436a and 436b formed in the bottom portion 402 of the housing. The posts may be secured in this position with adhesive, interference or snap fit arrangements, connectors or other fastening arrangements known in the art.

[0126] With reference to Fig. 35, the tissue tent bridge 414 also includes shoulders 438a and 438b. After the tissue tent bridge is secured to the bottom portion of the housing, the rotor 412 is turned slightly in the direction of arrow 456 into the position illustrated in Fig. 39 so that the shoulders 438a and 438b of the tissue tent bridge engage the undercuts 426 (Fig. 38) of the rotor.

[0127] As illustrated in Fig. 39, the tissue tent bridge 414 includes a central cup portion 442 that receives the bottom end of the push button compression spring (such as compression spring 266 of Fig. 26).

[0128] The simulated tissue tent injection needle cover 406 is next positioned as shown in Fig. 36 and, with reference to Fig. 35, a screw 446 or other fastener isdirected through a central opening 448 formed in the bottom of the tissue tent bridge so as to engage a corresponding threaded bore formed in the top of the simulated tissue tent injection needle cover 406. As a result, the components of Fig. 35 are secured together as illustrated in Figs. 36 and 39.

[0129] In an alternative embodiment, the tissue tent bridge 414 and the tissue tent injection needle cover 406 of Fig. 35 are formed as a single piece. In this embodiment, the central opening formed in winding disk 408 of the rotor 412 is sized to permit the tissue tent injection needle cover 406 to pass down therethrough and into the position illustrated in Fig. 36 during assembly of the injection device trainer.

[0130] As in the embodiment of Figs. 24-33, a ratchet gear, indicated in general at 452 in Fig. 40, includes a central opening into which extend ratchet tabs 454. The ratchet tabs are sized and angled so that when the rotor gear 416 (also shown in Figs. 38 and 39) is positioned within the ratchet gear central opening, in the same manner as the previous embodiment illustrated in Fig. 28, the ratchet tabs 454 engage the teeth of the rotor gear 416 so that the rotor 412 may only turn in the direction of arrow 456 of Fig. 40 when the ratchet gear 452 is free to turn in the direction of arrow 456. As in the embodiment of Figs. 26, 29 and 30, the ratchet gear is only free to turn in the direction of arrow 456 when a latch (such as 292 in Figs. 26, 29 and 30) is actuated by pushing a button (458 of Fig. 34) of the injection device 400.

[0131] As in the embodiment of Figs. 24-33, a rotor spring, which is preferably a tension spring and is indicated at 462 in Fig. 39, has a first end attached to the housing bottom portion via a post (not shown) and a second end attached to the rotor via tab 464 (with the spring shown disconnected in Fig. 39), so that the rotor412 is urged to rotate in the direction of arrow 456. Due to the ratchet tabs 454, the rotor gear may rotate only in a direction against the urging of the rotor spring with respect to the ratchet gear during winding of the injection device trainer.

[0132] A fill indicator ring, indicated in general at 472 in Figs. 39 and 40 is rotatably positioned within the bottom portion 42 of the housing. The fill indicator ring is provided with a fill indicator 474 which, as in the embodiment of Figs. 24- 33, is visible through a window formed in the upper portion 401 (Fig. 34) of the housing and rotates between a position indicating that the injection device is empty (simulated) to and from a position indicating that the injection device is full or partially filled (simulated) with liquid medication. The fill indicator ring is also provided with a fill indicator hook 476.

[0133] As illustrated in Figs. 39 and 40, a rotor hook 466 extends radially from the rotor 412. An elastic member such as an elastic band 482 or other elastic connector joins the rotor hook 466 and the fill indicator hook 476. The fill indicated 474 is shown in the empty position (i.e. corresponding to the injection device being simulated as empty) in Figs. 39 and 40.

[0134] With continued reference to Figs. 39 and 40, when the injection device is wound by a transfer device trainer (indicated in general at 496 in Fig. 41) so as to simulate filling with medical fluid, the rotor 412, and thus the rotor hook 466, travels in the direction of arrow 484 in Figs. 39 and 40 against the urging of tension spring 462 (Fig. 39). As the rotor hook 466 travels the direction of arrow 484 in Figs. 39 and 40, elastic band 482 pulls fill indicator hook 476 also in the direction of arrow 484, so that the fill indicator 474 trails the movement of the rotor hook 466. With reference to Fig. 39 a fill indicator stop wall 484, featuring a stop surface 486, is positioned under the fill indicator and extends radially inwardstowards the rotor. The fill indicator hook 476 trails the rotor hook 466 until the stop surface 486 engages a stop tab 488 or other stop structure formed on, or otherwise connected to, the bottom portion 402 of the injection device housing. At this point, movement of the fill indicator hook 476, and thus the fill indicator 474, stops, while movement of the rotor 412 and thus rotor hook 466, continues in the direction of arrow 484. Elastic connector 482 stretches as the rotor hook moves away from the fill indicator hook until the injection device is fully wound (representing the filled condition). For example, movement of the rotor hook could stop short of the post 492 of Fig. 39 that supports the ratchet gear latch described previously.

[0135] When a simulated injection is initiated, and the ratchet gear 452 (fig. 40) is released so that the rotor is free to travel in the direction of arrow 456 in Figs. 39 and 40, the rotor hook 466 will rotate towards the fill indicator hook 476 (and stop tab 488 of Fig. 39). Fill indicator hook 476, and thus the fill indicator 474, will remain stationary due to the engagement of the stop surface 486 with the stop tab 488, however, as the tension in the elastic band 482 is reduced. Only when the rotor hook 466 engages the fill indicator hook 476 will the fill indicator 474 begin moving back towards the empty position illustrated in Figs. 39 and 40.

[0136] The delay in simulated filling (i.e. completion of winding) that occurs after the fill indicator reaches the simulated “filled” or “partially filled” positions, and the delay in fill indicator movement after simulated initiation of an injection is begun may more accurately model operation of the actual injection device.

[0137] The injection device of Figs. 34-40 is wound by turning the winding disk 408 of Fig. 36 in the direction of arrow 494. To accomplish this, an embodiment of the injection device, indicated in general at 496 in Fig. 41 , is provided with atransfer device winding fitting 498 that includes upward extending winding posts 502 (also shown in Fig. 42). As illustrated in Fig. 42, the transfer device winding fitting 496 is positioned on top of a winding hub and damper gear 504, which is turned in the same manner as winding hub and damper gear 199 of Figs. 20-23. As a result, the transfer device winding fitting 498 rotates with respect to the injection device support surface 506 of Fig. 41 .

[0138] With reference to Figs. 35-37, the bottom side of winding disk 408 forms an injection device winding fitting including sockets 508 that correspond to and receive the winding posts 502 of Figs. 41 and 42 when the injection device 400 (Fig. 33) is mounted on the injection device support surface 506 of the transfer device 496 of Fig. 41. As a result, the winding disk 408 of the injection device is turned by the rotating transfer device winding fitting 496 so that the injection device is wound during a simulated filling by the transfer device.

[0139] While four winding posts 502 and sockets 508 are shown, the number of posts may be increased or decreased and / or the posts and sockets may feature alternative engaging shapes or structures. Furthermore, the posts and the sockets may be swapped with regard to which component they are positioned on.

[0140] As illustrated in Figs. 41 and 42, the transfer device winding fitting 498 features a central recess 512 that receives the simulated tissue tent injection needle cover 406 (Figs. 35 and 36), which remains stationary while the injection device is being wound, when the injection device is mounted on the transfer device.

[0141] 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 largerange of devices and systems that may differ in particular configuration and appearance while still employing this subject matter.

Claims

CLAIMS1 . A reusable transfer device trainer mechanism comprising: a. a vial elevator including a camming hook; b. a vial elevator shaft within which the vial elevator moves between an extended position and a retracted position; c. a cam ring rotatably positioned around the vial elevator, said cam ring including: i. 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; ii. a belt gripping surface; d. a winding assembly including: i. a center timing shaft featuring a winding sheave; ii. a clock spring having an inner end connected to the center timing shaft and an outer end; iii. a winding hub connected to the outer end of the clock spring and including a transfer device winding fitting; iv. a damper gear secured to the winding hub; e. a transfer device damper operatively engaging the damper gear. f. a drive belt engaging the belt gripping surface of the cam ring and the winding sheave of the center timing shaft so that when the cam ring rotates, the center timing shaft rotates.

2. a winding assembly including: a. a center timing shaft featuring a winding sheave; b. a clock spring having an inner end connected to the center timing shaft and an outer end; c. a winding hub connected to the outer end of the clock spring and including a transfer device winding fitting; d. a damper gear secured to the winding hub.

3. The winding assembly of claim 2 further comprising a transfer device damper operatively engaging the damper gear.

4. A reusable transfer device trainer comprising: a. a transfer device housing including an injection device mounting surface; 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: i. 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;ii. a belt gripping surface; e. a winding assembly including: i. a center timing shaft featuring a timing shaft recess having a timing shaft post positioned therein and a winding sheave; ii. a clock spring assembly including a clock spring positioned within a clock spring collar, said clock spring having an outer end attached to the clock spring collar and an inner end; iii. a winding hub including a transfer device winding fitting and a skirt portion defining a winding hub recess, said injection device mounting surface including a mounting surface opening corresponding to the transfer device winding fitting; iv. said clock spring collar positioned within the winding hub recess and secured to the winding hub skirt portion and said winding hub skirt portion positioned within the timing shaft recess with the inner end of the clock spring connected to the timing shaft post; v. a damper gear secured to the winding hub; f. a transfer device damper operatively connected to the damper gear. g. a drive belt engaging the belt gripping surface of the cam ring and the winding sheave of the center timing shaft so that when the cam ring rotates, the center timing shaft rotates.

5. The transfer device trainer of claim 4 further comprising: h. an injection device retaining strap extending over the injection device mounting surface and including a first end pivotally attachedto the transfer device housing and second end including a latching member; i. a latch release cam rotatably mounted within the transfer device housing and configured to secure the latching member of the second end of the retaining strap to the transfer device housing when in a first position and to release the latching member of the second end of the retaining strap when in a second position, said latch release cam including a release cam gear portion operatively engaging the damper gear so that the latch release cam is rotated from the first position to the second position during a portion of rotation of the damper gear.

6. The transfer device trainer of claim 5 wherein the latch release cam includes a ramp surface extending along a portion of a periphery of the latch release cam, said ramp surface engaging the latching member of the second end of the retaining strap until the latch release cam is rotated into the second position.

7. The transfer device trainer of claim 4 wherein the cam ring includes a camming member having an edge upon which the camming surface is formed, said camming member having an inward facing surface and including a reset camming surface on the inward facing surface, said reset camming surface configured to be traversed by the camming hook as the vial elevator moves from the retracted position to the extended positionwhereby the cam ring flexes to allow the camming hook to return to a starting position.

8. The transfer device trainer of claim 4 wherein the cam ring includes a plurality of beads spaced around a perimeter of the cam ring and further comprising a spring pin assembly including a mounting member, a pin having a tip and a pin spring engaging the mounting member and the pin, said mounting member positioned within the housing and said spring pin spring configured so that the tip of the pin is urged towards individual engagement with the plurality of beads as the cam ring rotates to simulate a desired feel.

9. The transfer device trainer of claim 4 further comprising a spring-loaded belt tensioner comprising a tensioner arm pivotally mounted within the housing, a pulley wheel mounted to a distal end of the tensioner arm and a tensioner spring configured to urge the pulley wheel towards engagement with the drive belt to increase tension within the drive belt.

10. The transfer device trainer of claim 9 wherein the tensioner spring is a torsion spring.11 . The transfer device trainer of claim 4 wherein the vial elevator includes first and second locking hooks and further comprising: h. a vial elevator shaft base including a pair of shuttle guides; i. a first locking shuttle including a first shuttle undercut and a first shuttle inclined surface;j. a second locking shuttle including a second shuttle undercut and a second shuttle inclined surface; k. said first and second locking shuttles slidably positioned within the pair of shuttle guides; l. a shuttle spring urging said first and second locking shuttles apart from an unlocking position towards a locking position; m. said first and second shuttle undercuts configured to engage the vial elevator first and second locking hooks when the vial elevator is in the retracted position and the first and second locking shuttles are in the locking position and said first and second shuttle undercuts configured to disengage from the vial elevator first and second locking hooks when the first and second locking shuttles are in the unlocking position; n. said first shuttle inclined surface opposing said second shuttle inclined surface and said first and second shuttle inclined surfaces configured to force the first and second locking shuttles towards the unlocking position when said first and second shuttle inclined surfaces are engaged by a reset tool.

12. The transfer device trainer of claim 11 further comprising a reset opening formed in the vial elevator shaft base through which a reset tool is inserted to engage said first and second shuttle inclined surfaces.

13. The transfer device trainer of claim 11 wherein the shuttle spring is a compression spring.

14. The transfer device trainer of claim 11 further comprising the reset tool.

15. The transfer device trainer of claim 14 wherein the reset tool is incorporated into product packaging for the transfer device trainer.

16. The transfer device trainer of claim 11 wherein the first locking shuttle includes a first locking shuttle flange and the second locking shuttle includes a second locking shuttle flange where said first and second locking shuttle flanges are slidably received within the pair of shuttle guides.

17. A mechanism for simulating an injection comprising: a. a push button spring urging the push button towards the raised position; b. a button claw including a first flex arm and a second flex arm configured to move with the push button between the raised and lowered positions, said first flex arm including a first locking tab and said second flex arm including a second locking tab; c. a rotor rotatably mounted within the injection device housing and movable between a first rotor position and a second rotor position, said rotor including a first undercut, a second undercut and a rotor gear having rotor gear teeth; d. a rotor spring urging the rotor towards the second rotor position; e. a ratchet gear having a central opening and at least one ratchet tab extending into the central opening;f. said rotor gear positioned within the central opening of the ratchet gear with the rotor gear teeth engaging the at least one ratchet tab so that the rotor gear may rotate only in a direction against the urging of the rotor spring with respect to the ratchet gear; g. a latch configured to releasably engage the ratchet gear so as to prevent rotation of the ratchet gear; h. said first and second undercuts of the rotor configured to be engaged by the first and second locking tabs of the flex arms against the urging of the push button spring when the push button is moved from the raised position to the lowered position and the rotor is in the first rotor position, said first and second undercuts configured to release the first and second locking tabs of the flex arms when the rotor is rotated into the second rotor position so that the push button is moved into the raised position by the push button spring; i. an injection device damper configured operatively engaging the rotor gear teeth; j. a winding shaft connected to the rotor so that the rotor turns with the winding shaft; k. an injection device winding fitting connected to said winding shaft, said injection device housing including an injection device winding fitting opening corresponding to the injection device winding fitting.

18. 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 first flex arm and a second flex arm configured to move with the push button between the raised and lowered positions, said first flex arm including a first locking tab and said second flex arm including a second locking tab; e. a rotor rotatably mounted within the injection device housing and movable between a first rotor position and a second rotor position, said rotor including a first undercut, a second undercut and a rotor gear having rotor gear teeth; f. a rotor spring urging the rotor towards the second rotor position; g. a ratchet gear having a central opening and at least one ratchet tab extending into the central opening; h. said rotor gear positioned within the central opening of the ratchet gear with the rotor gear teeth engaging the at least one ratchet tab so that the rotor gear may rotate only in a direction against the urging of the rotor spring with respect to the ratchet gear; i. a latch positioned within the housing and configured to releasably engage the ratchet gear so as to prevent rotation of the ratchet gear; j. said first and second undercuts of the rotor configured to be engaged by the first and second locking tabs of the flex arms against the urging of the push button spring when the push button is moved from the raised position to the lowered position and the rotor is in thefirst rotor position, said first and second undercuts configured to release the first and second locking tabs of the flex arms when the rotor is moved into the second rotor position so that the push button is moved into the raised position by the push button spring; k. an injection device damper operatively engaging the rotor gear teeth; l. a winding shaft connected to the rotor so that the rotor turns with the winding shaft; m. an injection device winding fitting connected to said winding shaft, said injection device housing including an injection device winding fitting opening corresponding to the injection device winding fitting.

19. The injection device trainer of claim 18 wherein the first undercut and the second undercut are separate and spaced from each other.

20. The injection device trainer of claim 18 where the push button has a finger configured to engage the latch so that the latch disengages from the ratchet gear when the push button is moved to the lowered position.21 . The injection device trainer of claim 18 wherein the injection device housing includes a top portion including a push button opening and a bottom portion including the injection device winding fitting opening.

22. The injection device trainer of claim 21 wherein the top portion of the injection device housing includes a socket defining the push button opening, said socket including a first button track and a second buttontrack, and wherein the push button includes a first guide tab and a second guide tab with said first guide tab slidably received within the first button track and said second guide tab slidably received within the second button track.

23. The injection device trainer of claim 18 wherein the rotor includes a fill indicator.

24. The injection device trainer of claim 18 wherein the rotor includes a rotor hook and further comprising: a fill indicator; a fill indicator hook secured to the fill indicator; a fill indicator stop surface secured to the fill indicator; a stop structure secured to the housing and an elastic member connecting the fill indicator hook to the rotor hook so that the fill indicator rotates with the rotor to a first direction until the fill indicator stop surface engages the stop structure while the rotor hook travels beyond the stop structure in the first direction against the urging of the elastic member.

25. The injection device trainer of claim 24 further comprising a fill indicator ring upon which the fill indicator is mounted, said fill indicator ring rotatably mounted within the injection device housing.

26. The injection device trainer of claim 24 wherein the elastic member is an elastic band.

27. A reusable transfer device and injection device training system comprising: a. a transfer device trainer including: i. a transfer device housing including an injection device mounting surface;ii. a vial elevator positioned within the transfer device housing configured to receive a vial, said vial elevator including a camming hook; iii. a vial elevator shaft within which the vial elevator moves between an extended position and a retracted position; iv. a cam ring rotatably positioned around the vial elevator, said cam ring including: v. 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; vi. a belt gripping surface; vii. a winding assembly including:1 . a center timing shaft featuring a timing shaft recess having a timing shaft post positioned therein and a winding sheave;2. a clock spring assembly including a clock spring positioned within a clock spring collar, said clock spring having an outer end attached to the clock spring collar and an inner end;3. a winding hub including a transfer device winding fitting and a skirt portion defining a winding hub recess, said injection device mounting surface including a mounting surface opening corresponding to the transfer device winding fitting;4. said clock spring collar positioned within the winding hub recess and secured to the winding hub skirt portion and said winding hub skirt portion positioned within the timing shaft recess with the inner end of the clock spring connected to the timing shaft post;5. a damper gear secured to the winding hub; viii. a damper operatively connected to the damper gear. ix. a drive belt engaging the belt gripping surface of the cam ring and the winding sheave of the center timing shaft so that when the cam ring rotates, the center timing shaft rotates. b. an injection device trainer positioned on the injection device mounting surface of the transfer device trainer, said injection device trainer comprising: i. an injection device housing; ii. a push button mounted within the injection device housing and movable between a raised position and a lowered position; iii. a push button spring urging the push button towards the raised position; iv. a button claw including a first flex arm and a second flex arm configured to move with the push button between the raised and lowered positions, said first flex arm including a first locking tab and said second flex arm including a second locking tab;v. a rotor rotatably mounted within the injection device housing and movable between a first rotor position and a second rotor position, said rotor including a first undercut, a second undercut and a rotor gear having rotor gear teeth; vi. a rotor spring urging the rotor towards the second rotor position; vii. a ratchet gear having a central opening and at least one ratchet tab extending into the central opening; viii. said rotor gear positioned within the central opening of the ratchet gear with the rotor gear teeth engaging the at least one ratchet tab so that the rotor gear may rotate only in a direction against the urging of the rotor spring with respect to the ratchet gear; ix. a latch positioned within the housing and configured to releasably engage the ratchet gear so as to prevent rotation of the ratchet gear; x. said first and second undercuts of the rotor configured to be engaged by the first and second locking tabs of the flex arms against the urging of the push button spring when the push button is moved from the raised position to the lowered position and the rotor is in the first rotor position, said first and second undercuts configured to release the first and second locking tabs of the flex arms when the rotor is moved into the second rotor position so that the push button is moved into the raised position by the push button spring;xi. an injection device damper operatively engaging the rotor gear teeth; xii. a winding shaft connected to the rotor so that the rotor turns with the winding shaft; xiii. an injection device winding fitting connected to said winding shaft, said injection device housing including an injection device winding fitting opening corresponding to the injection device winding fitting; xiv. said injection device winding fitting engaging said transfer device winding fitting.

28. The transfer device and injection device training system of claim 27 further comprising a pair of locator pins positioned on the injection device support surface of the transfer device trainer and wherein said injection device trainer includes a pair of corresponding locator openings receiving the pair of locator pins.

29. The transfer device and injection device training system of claim 27 wherein the transfer device trainer further includes: x. an injection device retaining strap securing the injection device trainer to the injection device mounting surface of the transfer device trainer, said retaining strap including a first end pivotally attached to the transfer device housing and second end including a latching member; andxi. a latch release cam rotatably mounted within the transfer device housing and configured to secure the latching member of the second end of the retaining strap to the transfer device housing when in a first position and to release the latching member of the second end of the retaining strap when in a second position, said latch release cam including a release cam gear portion operatively engaging the damper gear so that the latch release cam is rotated from the first position to the second position during a portion of rotation of the damper gear.

30. The injection device trainer of claim 27 wherein the rotor includes a fill indicator.31 . The injection device trainer of claim 27 wherein the rotor includes a rotor hook and further comprising: a fill indicator; a fill indicator hook secured to the fill indicator; a fill indicator stop surface secured to the fill indicator; a stop structure secured to the housing and an elastic member connecting the fill indicator hook to the rotor hook so that the fill indicator rotates with the rotor to a first direction until the fill indicator stop surface engages the stop structure while the rotor hook travels beyond the stop structure in the first direction against the urging of the elastic member.

32. The injection device trainer of claim 31 further comprising a fill indicator ring upon which the fill indicator is mounted, said fill indicator ring rotatably mounted within the injection device housing.

33. The injection device trainer of claim 31 wherein the elastic member is an elastic band.

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