Injection device trainer

Abstract

An injection device trainer has a push button provided with a needle and is movable between a raised start position and a lowered dispense position. A button guide is rotatably attached to the push button and includes a channel having Dispense and Start stop locations corresponding to the dispense and start positions of the push button. A spline traverses the channel as the push button is raised and lowered so as to move between the stop locations of the channel. A needle traverses a central passion and sealing zone of a septum. Upper and lower side holes of the needle are configured to be (i) on opposite sides of the sealing zone of the septum when the spline is in the Dispense stop location and the push button is in the dispense position, and (ii) both above the sealing zone of the septum when the spline is in the Start stop location and the push button is in the stop position. As a result, an air supply line provides air to the septum central passage when the push button is in the dispense position.

Description

INJECTION DEVICE TRAINERINVENTORS: Rowan Converse, Kory GunnersonCLAIM OF PRIORITY

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 674,366, filed July 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 medical fluid injection devices and, in particular, to training devices or trainers for demonstrating and instructing users on the proper use of such injection 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.

[0004] Potential users of on-body injection devices must be trained on how to properly use them. Additional situations may occur where demonstration of use of the injection devices is needed. Reusable training versions of such injection devices are desirable for such purposes. Such training versions preferably include features that permit simulated operation of the injection devices while permitting them to be reset for future use after a training or demonstration session. In addition, training versions of injection devices which avoid the potential for accidental needle sticks are desirable.SUMMARY

[0005] There are several aspects of the present subject matter which may be embodied separately or together in the devices and systems described andclaimed 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, an injection device trainer includes an injection device trainer housing with a push button mounted therein that is movable between a raised start position and a lowered dispense position. A spring urges the push button towards the raised start position. A button guide is rotatably attached to the push button and includes a channel having Dispense and Start stop locations corresponding to the dispense and start positions of the push button, respectively, with camming surfaces therebetween. A spline is secured to and fixed within the housing. The spline is positioned in and traverses the channel as the push button is raised and lowered so as to move between the stop locations of the channel. A needle is positioned in the housing and connected to the push button so as to be raised and lowered with the push button. The needle includes an internal passage with upper and lower side holes in fluid communication with the internal passage. A septum is positioned within the housing and defines a central passage including a seal zone that forms a circumferential seal around the needle. The upper and lower side holes of the needle are configured to be (i) on opposite sides of the seal zone of the septum when the spline is in the Dispense stop location and the push button is in the dispense position, and (ii) both above the seal zone of the septum when the spline is in the Start stop location and the push button is in the stop position. An air supply line has an air passage thatprovides air to the central passage from a source of pressurized air when the push button is in the dispense position.BRIEF DESCRIPTION OF DRAWINGS

[0007] Figure 1 is a perspective view of an embodiment of the injection device trainer of the disclosure.

[0008] Figure 2 is a cross-sectional view of the injection device trainer taken along line 2-2 of Figure 1 .

[0009] Figure 3 is a top plan view of the injection device trainer of Figure 1 with a safety strip installed.

[0010] Figure 4 is cross-sectional view of the injection device trainer of Figure 3 taken along line 4-4 of Figure 3.

[0011] Figure 5A is an enlarged cross-sectional side elevational view of the injection simulation mechanism of injection device trainer of Figure 4 in the “Start” configuration.

[0012] Figure 5B is cross-sectional side elevational view of the injection simulation mechanism of Figure 5A in the “Dispense” configuration

[0013] Figure 5C is a cross-sectional side elevational view of the injection simulation mechanism of Figures 5A and 5B in the “Pause” configuration.

[0014] Figure 5D is a cross-sectional side elevational view of the injection simulation mechanism of Figures 5A-5C in the “Lockout” configuration.

[0015] Figure 6 is a cross-section side elevational view of an alternative embodiment of the injection simulation mechanism of the injection device trainer of the disclosure in the “Start” configuration.DESCRIPTION

[0016] 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, and the on-body injection devices described below. Each of these injection devices includes an 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.

[0017] Transfer devices known in the art may be used to fill the on-body injection devices described above with medical fluid. Such transfer devices may include syringes and syringe-powered transfer devices or gas-powered transfer devices. Examples of the latter are disclosed in in commonly assigned U.S. Patent No. 11 ,571 ,251 to Bourelle et al., issued February 7, 2023, and U.S.Patent Application Publication No. US 2023 / 0285243 to Drach et al., published September 14, 2023, the contents of each of which are hereby incorporated by reference in their entirety.

[0018] In addition to the pre-dispense or “Start” configuration and the “Dispense” configuration, the injection device disclosed in U.S. Patent No. 9,925,333 to Hooven et al. which, as noted previously, is incorporated herein byreference in its entirety, includes a post-injection lockout feature (a “Lockout” configuration) that prevents the push button of the injection device from being pressed after an injection is completed. As a result, deployment of the injection cannula is prevented after the injection is completed. In addition, the injection device trainer may be temporarily placed in the “Pain Pause” or “Pause” configuration, whereby the flow of liquid to the injection cannula is halted, by the user pressing the push button further downwards when the injection device is in the Dispense configuration. Dispensing may resume when the push button is released.

[0019] An embodiment of the injection device trainer of the disclosure is indicated in general at 10 in Figs. 1-4. The injection device trainer features a housing, indicated in general at 12, having a top portion 14a and a bottom portion 14b. A push button 16 for actuating the injection device trainer, as described in greater detail below, extends through a central opening 18 formed in the top portion 14a of the housing.

[0020] As illustrated in Fig. 4, a compression coil spring 22 urges the push button 16 into the raised position and ultimately, as explained in greater detail below, towards a lock-out position. The push button 16 may be pushed down against the urging of the coil spring into the central opening 18 of the housing 12. In alternative embodiments of the injection device trainer, an alternative type of spring may be used in place of the compression coil spring 22.

[0021] As illustrated in Fig. 2, the push button 16 has a cylindrical button guide24 rotatably attached thereto and positioned within the housing 12. As a result, the button guide 24 and the push button 16 move together vertically within the housing 12. The button guide 24 includes a recessed pathway or channel 26. Aspline 28 is secured and fixed with respect to the housing 12 and extends radially inwards so that a distal portion of the spline is received by the channel 26.

[0022] The button guide 24 is free to turn within central opening 18 with respect to housing 12 and push button 16, as indicated by arrow 32 of Fig. 2. As a result, the spline 28 traverses the channel 26 as the push button 16 is pushed by a user and raised after the user releases the push button under the urging of the compression spring (22 of Fig. 4). Due to the ramped camming surfaces of the channel 26, as described below, the button guide 24 rotates in the clockwise direction (i.e. in the direction of arrow 32 in Fig. 2) as the push button 16 is pushed and released by the user.

[0023] As illustrated in Fig. 2, the channel 26 has a number of stop locations for the spline 28 incorporated therein, where each stop location corresponds to a simulated configuration of the injection device trainer. These stop locations include a Lock-out stop 42, a Ready to Fire stop 44, a Dispense stop 46 and a Pause stop 48. Each of these will be described below with reference to the corresponding configuration of the injection device trainer.

[0024] Prior to a demonstration or a training session, or as part of each, the elastomeric bladder 52 (Figs. 2 and 4) is filled with air so that it expands both longitudinally and radially. This may be accomplished by inserting the tip of a syringe (not shown) containing air into the fill port 54 (Figs. 2 and 4) of the injection device trainer and advancing the plunger or using syringe-powered liquid medication transfer devices or gas-powered liquid medication transfer devices, referenced previously, with air substituted for the liquid medication.

[0025] With reference to Fig. 4, the injection device trainer 10 of the disclosure includes an injection simulation mechanism 56, positioned in the center of housing12. Enlarged views of the injection simulation mechanism 56 of the injection device trainer 10 of Fig. 4 are presented in Figs. 5A-5D and show configurations of the injection simulation mechanism corresponding to the stop locations of the push button channel described above with reference to Fig. 2.

[0026] In Fig. 5A, the injection simulation mechanism 56 is in the Ready to Fire (or “Start”) configuration. This corresponds to, with reference to Fig. 2, the button guide 24, and thus the push button 16, being positioned with the spline 28 located at the Ready to File stop location 44 of channel 26.

[0027] With reference to Fig. 5A, the injection simulation mechanism 56 includes a cannula or needle, indicated in general at 58 having an interior passageway. The needle 58 is attached to the push button 16 and extends downwards therefrom so that the needle is lowered as the push button is pressed and released, respectively. The needle 58 includes a sealed top end 62 and a sealed bottom end 64 so that the top and bottom ends of the needle interior passageway are sealed. In addition, the needle includes an upper side hole 66 and a lower side hole 68, each of which is in fluid communication with the needle interior passageway.

[0028] A septum cap 72 includes an opening 75 through which the needle 58 passes. A septum 76 is constructed of elastomeric material and includes a central passage 74. The septum 76 also includes a seal zone 79 formed at the top of the central passage 74 that circumferentially seals against the exterior of the needle sidewall. As a result, air can only flow out of the septum central passage 74 when the upper side hole 66 is above the seal zone 79 and the lower side hole 68 is below the seal zone. As shown in Fig. 5A, the septum 76 is positioned within theseptum cap 72. As an example only, the septum may be secured to the septum cap by heat staking in order to create an air-tight seal.

[0029] A manifold 78 is secured and sealed to the bottom portion of the septum cap 72. As an example only, the manifold 78 may be secured to the septum cap 72 via adhesive at joint 82. The manifold 78 may also be secured to the lower portion 14b of the housing by adhesive at joint 84. The manifold 78 includes a manifold cavity 86 that is in fluid communication with the central passage 74 within the septum 76.

[0030] With continued reference to Fig. 5A, an air supply line 88 includes an air passage 92 that receives air from the injection device trainer elastomeric bladder 52 (Figs. 2 and 4) in the manner described below. In alternative embodiments, an alternative source of pressurized air may be used in place of the elastomeric bladder 52. The air passage 92 is provided with an air flow restrictor 94 through which air from air supply line 88 flows into the manifold cavity 86 and septum central passage 74. While the illustrated air flow restrictor 94 takes the form of a reduced flow passage size or orifice, other types of air flow restrictors known in the art, including but not limited to valves, may be used instead.

[0031] When the injection simulation mechanism 56 is in the Ready to Fire (or “Start”) configuration of Fig. 5A, both the upper and lower side holes 66 and 68 are positioned above the seal zone 79 of the septum 76. As a result, air is trapped within the manifold cavity 86 and the central passage 74 so that air from the elastomeric bladder of the injection device trainer cannot flow through air passage 92 and air flow restrictor 94 into the manifold cavity and central passage.

[0032] To simulate initiation of an injection, with reference to Fig. 2, the push button 16 is pressed so that the spline 28 travels up through the portion ofchannel 26 extending between Ready to Fire stop location 44 and Dispense stop location 46. As a result, spline 28 engages and traverses camming surface 96 (and the opposing camming surface), and the button guide 24 rotates clockwise, as the push button 16 is pressed. When the push button 16 is released, the spline 28 engages and traverses camming surface 98 (and the opposing camming surface) due to the upward urging of the compression spring 22 (Fig. 5A). As a result, the button guide 24 is further rotated clockwise slightly and the spline 28 comes to rest in the Dispense stop location 46 of Fig. 2. As this occurs, due to the push button 16 being lowered, the needle 58 is lowered into the position illustrated in Fig. 5B which corresponds to the Dispense configuration of the injection simulation mechanism 56.

[0033] When the injection simulation mechanism 56 is in the Dispense configuration illustrated in Fig. 5B, the upper side hole 66 is positioned above the seal zone 79 of the septum 76 while the lower side hole 68 is positioned below the seal zone 79 and within the septum central passage 74. As a result, air from the central passage 74, and thus air from manifold cavity 86, enters the lower side hole 68 and exits the upper side hole 66 and is vented from under the button cap 16 (which is not sealed with respect to the housing of the injection device trainer) to atmosphere. Air from the injection device trainer elastomeric bladder is thereby permitted to flow into the manifold cavity 86 and the central passage 74 through air passage 92, and vent through the needle lower and upper side holes 68 and 66. This simulates the flow of liquid medication from the elastomeric bladder (52 of Figs. 2 and 4) into a patient during an injection.

[0034] The air flow restrictor 94 decreases the flow rate of the air from the elastomeric bladder into the manifold cavity 86 and central passage 74 toapproximate the flow rate of liquid medication through the injection needle or cannula during an injection. Alternatively, the air flow restrictor 94 could be selected to provide a flow rate corresponding to a faster injection time (to speed up a demonstration or training) or a slower flow rate, if desired.

[0035] With reference to Fig. 2, pausing of an injection may be simulated by pressing down on push button 16 so that spline 28 travels up through the portion of channel 26 between the Dispense stop location 46 and the Pause stop location 48. As a result, spline 28 engages and traverses camming surface 102 (and the opposing camming surface), and the button guide 24 rotates clockwise, as the push button 16 is pressed until the spline travels into the Pause stop location 48 of the channel 26. As in the case of the actual medical injection device, the push button must be held in a depressed condition by the user to keep the spline 28 in the Pause stop location 48, and thus the injection device trainer in the simulated Pause configuration.

[0036] In Fig. 5C, the injection simulation mechanism 56 is shown in the Pause configuration corresponding to the spline 28 of Fig. 2 being positioned at stop location 48. As illustrated in Fig 5C, both the needle lower and upper side holes 68 and 66 have passed below the seal zone 79. As a result, air cannot escape from the septum central passage 74 (and manifold cavity 86) through the interior passageway of the needle 58 and delivery of air there to through air passage 92 and air flow restrictor 94 is halted, thus simulating a pause in the delivery of liquid medication to a patient.

[0037] With reference to Fig. 2, when the user wishes to return to theDispense configuration, the push button 16 is released, the spline 28 engages and traverses camming surface 104 (and the opposing camming surface) due tothe upward urging of the compression spring 22 (Fig. 5A). As a result, the button guide 24 is rotated clockwise slightly and the spline 28 comes to rest in a second Dispense stop location 46a of Fig. 2. As a result, the injection simulation mechanism returns to the Dispense configuration illustrated in Fig. 5B.

[0038] As shown in Fig. 2, the channel 26 is provided with a number of additional Dispense stop locations 46b and 46c with a number of intervening Pause stop locations 48a and 48b. As a result, multiple Pause steps with returns to Dispense steps may be performed during a demonstration or training session.

[0039] As explained previously, after completion of an injection using the actual medical injection device, a Lock-out configuration is entered by the injection device whereby the injection needle is withdrawn into the injection device housing and cannot be extended by pressing the push button.

[0040] With reference to Fig. 2, when the final Dispense configuration is reached during a training session or demonstration, the spline 38 will be positioned in the Dispense stop location 46c of the channel 26. The Lock-out configuration described above may be simulated by pressing the push button 16 so that the spline 28 rises into stop location 106 and then released. When this occurs, the compression coil spring of the injection device urges the push button 16 upwards so that the spline travels through the portion of the channel 26 extending from stop location 106 to the Lock-out stop location 42 of the channel. As a result, due to camming surfaces 108 and 110 acting on the spline 28, the button guide 24 rotates slightly clockwise and the spline comes to rest at Lock-out stop location 42.

[0041] The Lock-out configuration of the injection simulation mechanism 56 corresponding to the spline 28 of Fig. 2 being positioned at the Lock-out stoplocation 42 of channel 26 is illustrated in Fig. 5D. When in this configuration, both the upper and lower side holes 66 and 68 are positioned above the seal zone 79 of the septum 76. As a result, air is again trapped within the manifold cavity 86 and the septum central passage 74 so that air from the elastomeric bladder of the injection device trainer cannot flow through air passage 92 and air flow restrictor 94 into the manifold cavity and central passage.

[0042] With reference to Fig. 2, when the injection device trainer is in the simulated Lock-out configuration, with the spline 28 positioned at Lock-out stop location 42, the nearly flat (very slight camming surfaces) profile of the portion 111 of channel 26 between Lock-out stop location 42 and stop location 122 simulates the injection device trainer being in the Lock-out configuration as the push button 116 will lower only very slightly when a user tries to press it.

[0043] The injection simulation mechanism 56 may be returned to the Ready to Fire (or “Start”) configuration of Fig. 5A, with the spline 28 located at the Ready to File stop location 44 of channel 26, by pressing the push button 16 multiple times so that it traverses channel portion 111 (due to the very slight camming surfaces) and the button guide 24 slowly rotates clockwise (arrow 32 in Fig. 2) so that the spline 28 travels to stop location 112 of the channel 26. The user then slightly pushes the push button 16 so that the spline traverses camming surfaces 114 and 116 (and the corresponding opposing camming surfaces), with the button guide 24 rotating further clockwise, and is reset back to the Ready to Fire (or “Start”) stop location 44. The injection simulation mechanism 56, and thus the injection device trainer, is in the corresponding Ready to Fire configuration of Fig. 5A, and may be used for another demonstration or training session.

[0044] It should be noted that the channel 26 of Fig. 2 may be configured so that that the injection device trainer may go through the configurations of Figs. 5A- 5D a number of times per one 360 degree rotation of the button guide 24 or, alternatively, the injection device trainer may go through the configurations of Figs. 5A-5D only one time per single 360 degree rotation of the button guide.

[0045] It should be further noted that, in alternative embodiments, the Lockout and / or Pause stop locations may be omitted from the channel with the corresponding configuration or configurations omitted from the injection simulation mechanism.

[0046] An alternative version of the injection simulation mechanism is indicated in general at 156 in Fig. 6 in the Ready to Fire (or “Start”) configuration. The compression coil spring 22 of Fig. 5A is present in this embodiment, but has been omitted from Fig. 6 for clarity. With the exception of the details described below, the injection simulation mechanism of Fig. 6 operates in the same manner as the injection simulation mechanism of Figs. 5A-5D.

[0047] With reference to Fig. 6, the injection simulation mechanism 156 includes a cannula or needle, indicated in general at 158 having the same construction and features as the needle 58 of Fig. 5A. As in the embodiment of Fig. 5A, the needle 158 is attached to a push button 116 and extends downwards therefrom so that the needle is lowered as the push button is pressed and released, respectively.

[0048] An air injector tip or septum cap 172 includes an opening 175 through which the needle 158 passes. A septum 176 constructed of elastomeric material features a central passage 174 having a seal zone 179 in the top portion of the passage that circumferentially seals against the exterior of the needle sidewall.As a result, air can only flow out of the septum central passage 174 when the upper side hole of the needle 158 is above the seal zone 179 and the lower side hole of the needle 158 is below the seal zone 179. A tube 181 is inserted into the bottom portion of the central passage 174 of the septum 176 and, due to an interference fit between the tube 181 and the central passage 174, the corresponding portion of the septum 176 is pushed outwards in the radial direct so as to form a compression seal 183 against the inner wall of the septum cap 172. As examples only, the tube 181 may be constructed from stainless steel and the septum cap 172 may be 3D printed.

[0049] As in the embodiment of Fig. 5A, a manifold 178 in the embodiment of Fig. 6 is secured and sealed to the bottom portion of the septum cap 172 and receives air from an air supply line (88 in Fig. 5A).

[0050] 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 . An injection device trainer comprising: a. an injection device trainer housing; b. a push button mounted within the injection device trainer housing and movable between a raised start position and a lowered dispense position; c. a spring urging the push button towards the raised start position; d. a button guide rotatably attached to the push button, said button guide including a channel having Dispense and Start stop locations corresponding to the dispense and start positions of the push button, respectively, with camming surfaces therebetween; e. a spline secured to and fixed within the housing, said spline positioned in and traversing the channel as the push button is raised and lowered so as to move between the stop locations of the channel; f. a needle positioned in the housing and connected to the push button so as to be raised and lowered with the push button, said needle including an internal passage and upper and lower side holes in fluid communication with the internal passage; g. a septum positioned within the housing and defining a central passage including a seal zone forming a circumferential seal around the needle; h. said upper and lower side holes of the needle configured to be:i) on opposite sides of the seal zone of the septum when the spline is in the Dispense stop location and the push button is in the dispense position; ii) both above the seal zone of the septum when the spline is in the Start stop location and the push button is in the start position; i. an air supply line having an air passage that is configured to provide air to the central passage of the septum from a source of pressurized air when the push button is in the dispense position.

2. The injection device trainer of claim 1 further comprising an air flow restrictor configured to receive air flow from the air passage.

3. The injection device trainer of claim 2 wherein the air flow restrictor is positioned within the air passage.

4. The injection device trainer of claim 3 wherein the air flow restrictor includes an orifice.

5. The injection device trainer of claim 1 wherein the button guide is cylindrical.

6. The injection device trainer of claim 1 wherein the spring is a compression coil spring.

7. The injection device trainer of claim 1 further comprising a manifold defining a manifold cavity, said manifold cavity in fluid communication with the air supply line and the central passage of the septum.

8. The injection device trainer of claim 1 wherein the source of pressurized air is an expanded elastomeric bladder containing air.

9. The injection device trainer of claim 1 wherein the push button is movable between a raised lock-out position and a lowered pause position through the start position and the dispense positions which are located between the lockout position and the pause position, and wherein the channel of the button guide further includes a Lock-out stop location where the push button is in the lock-out position when the spline is in the Lock-out stop location of the channel and the upper and lower side holes of the needle are both positioned above the seal zone of the septum when the push button is in the lock-out position and wherein the channel of the button guide further includes a Pause stop location where the push button is in the pause position when the spline is in the Pause stop location of the channel and the upper and lower side holes of the needle are both positioned below the seal zone of the septum when the push button is in the pause position.

10. The injection device trainer of claim 1 wherein the push button is movable between a raised lock-out position and the lowered dispense position through the start position which is located between the lock-out position and the dispense position, and wherein the channel of the button guide further includes a Lock-out stop location where the push button is in the lock-out position when the spline is inthe Lock-out stop location of the channel and the upper and lower side holes of the needle are both positioned above the seal zone of the septum when the push button is in the lock-out position.11 . The injection device trainer of claim 1 wherein the push button is movable between the raised start position and a lowered pause position through the dispense position which is located between the start position and the pause position, and wherein the channel of the button guide further includes a Pause stop location where the push button is in the pause position when the spline is in the Pause stop location of the channel and the upper and lower side holes of the needle are both positioned below the seal zone of the septum when the push button is in the pause position.

12. The injection trainer device of claim 11 wherein the channel includes multiple Dispense and Pause stop locations.

13. The injection trainer device of claim 1 further comprising a septum cap within which the septum is positioned and further comprising a manifold secured and sealed to a bottom portion of the septum cap, said manifold including a manifold cavity that is in fluid communication with the central passage of the septum and configured to receive air from the air supply line and direct it to the central passage of the septum.

14. The injection trainer device of claim 13 wherein the manifold is secured to the septum cap by adhesive.

15. The injection trainer device of claim 13 wherein the septum is secured to the septum cap by heat staking.

16. The injection trainer device of claim 13 wherein the septum is made of elastomeric material.

17. The injection trainer device of claim 16 wherein a tube is received in an interference fit fashion within the central passage of the septum, said tube sized so that an exterior surface of the septum seals against an interior wall of the septum cap.

18. The injection trainer device of claim 17 wherein the tube is received within a lower portion of the septum central passage.

19. The injection trainer device of claim 17 wherein the tube is made of stainless steel.

20. The injection trainer of claim 13 wherein the septum cap is 3D printed.

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