Training device and method for simulating intranasal drug delivery

Abstract

Various training devices and methods for simulating intranasal drug delivery are described. In one exemplary embodiment, the training device can include an outer sleeve, a locking sleeve coupled to the outer sleeve, a core sleeve coupled to the locking sleeve, and a plunger operably coupled to the core sleeve. The plunger can be configured to selectively translate the core sleeve from an initial position to a first actuated position indicating the release of a first simulated dose of drug, and from the first actuated position to a second actuated position indicating the release of a second simulated dose of drug, wherein the device does not contain drug. The plunger can also be configured to rotate relative to the outer sleeve to reset the core sleeve to its initial position so that the core sleeve can be translated back to the first and second actuated positions.

Description

[Technical Field]

[0001] A training device and method for simulating intranasal drug delivery is disclosed. [Background technology]

[0002] There are many different ways in which drugs can be administered to a user. Depending on the drug, intranasal drug delivery can be one of the most effective ways to achieve the desired clinical benefit in a timely, convenient, and comfortable manner for the patient.

[0003] Intranasal drug administration is a non-invasive route for drug delivery. The nasal mucosa offers many advantages as a target tissue for drug delivery, allowing a wide variety of drugs to be administered via intranasal systemic action. Furthermore, intranasal drug delivery can avoid the risks and discomfort associated with other routes of drug delivery (e.g., intravenous drug delivery) and can facilitate easy self-administration.

[0004] Generally, to maximize the effectiveness of intranasal drug administration, the majority of the volume of the aerosolized dose of drug must reach the correct region of the nasal cavity. Therefore, additional measures may be required for effective intranasal drug delivery. For example, the user may need to hold their nostrils open, tilt their head back approximately 45 degrees, close the opposite nostril, and then gently inhale through their nose while the drug dose is being administered. To adjust these measures, and given the individual nature of nasal administration, self-administration by the user may be desirable. Furthermore, due to nasal cycling (alternating physiological partial blockage of the nasal turbinates to facilitate nasal function) or pathological blockage, one nostril is likely to provide a more effective drug delivery route than the other at any given time. Therefore, to prevent underdosing, it is desirable to deliver an equivalent dose of drug to each nostril of the user.

[0005] Dual-dose intranasal drug delivery devices are available that are designed for self-administration of two separate aerosolized sprays, one for each nostril, that together constitute a single dose of drug. These devices require a series of operational steps that the user must properly perform to provide optimal drug delivery via self-administration. While users are typically provided with user manuals, commonly referred to as instructions for use (IFUs), these manuals are limited to illustrating and textually explaining the operational steps for using the device. As a result, before use, users lack tactile experience in using the device, which can lead to user misuse of the device and ultimately prevent effective drug delivery. Summary of the Invention [Problem to be solved by the invention]

[0006] Therefore, there remains a need for a training device that simulates the use of an intranasal drug delivery device without the need to deliver any drug to the user. [Means for solving the problem]

[0007] Various training devices and methods for simulating intranasal drug delivery are disclosed.

[0008] In one exemplary embodiment, a training device is provided including an outer sleeve having an upper portion and a lower portion, a locking sleeve coupled to the outer sleeve and extending partially through the outer sleeve, a core sleeve coupled to the locking sleeve and configured to slide axially within the outer sleeve and the locking sleeve, the core sleeve having first and second sets of locking features, and a plunger operably coupled to the core sleeve, the plunger configured to selectively translate the core sleeve from an initial position to a first actuation position in response to application of a first actuation force exceeding a first force threshold, the plunger configured to translate the core sleeve from the first actuation position to a second actuation position in response to application of a second actuation force exceeding a second force threshold, the first force threshold corresponding to a first nebulization threshold for releasing a first simulated dose of a drug, the second force threshold corresponding to a second nebulization threshold for releasing a second simulated dose of the drug, and the device does not contain a drug.

[0009] In some embodiments, the training device can include a protective sanitary cap that can be selectively matable with and removable from the device.

[0010] The first and second sets of locking features can have various configurations. For example, in some embodiments, the first set of locking features can each include first and second flanges extending from the outer surface of the core sleeve and a first locking groove defined therebetween, where the first locking groove can be configured to retain the core sleeve in the first actuation position. The second set of locking features can each include third and fourth flanges extending from the outer surface of the core sleeve and a second locking groove defined therebetween, where the second locking groove can be configured to retain the core sleeve in the second actuation position. In certain embodiments, the locking sleeve can include at least two snap arms, each having a protrusion extending from its inner surface toward the core sleeve, where each protrusion can be configured to engage with the first locking groove when the core sleeve is in the first actuation position and can be configured to engage with the second locking groove when the core sleeve is in the second actuation position.

[0011] In some embodiments, the plunger can return to the starting position after application of the first actuation force and after application of the second actuation force.

[0012] In some embodiments, the training device can include an indicator rod mounted within the upper portion of the outer sleeve. The indicator rod can be visible through first and second indicator windows in the upper portion when the core sleeve is in the initial position. In such embodiments, the core sleeve can be configured to slide between the indicator rod and the upper portion of the outer sleeve such that the core sleeve blocks the first indicator window when the core sleeve is in the first actuated position. In certain embodiments, the core sleeve can also block the first and second indicator windows when the core sleeve is in the second actuated position.

[0013] In another exemplary embodiment, a training device is provided that includes an outer sleeve having an upper portion and a lower portion, a locking sleeve coupled to the outer sleeve and extending partially through the outer sleeve, a core sleeve coupled to the locking sleeve and configured to slide axially within the outer sleeve and the locking sleeve, the core sleeve having first and second sets of locking features, and a plunger operably coupled to the core sleeve, the plunger configured to selectively translate from an initial position to a first actuated position indicating the release of a first simulated dose of the drug, the plunger configured to translate the core sleeve from the first actuated position to a second actuated position indicating the release of a second simulated dose of the drug, wherein the device does not contain the drug.

[0014] In some embodiments, the training device can include an indicator rod disposed within the upper portion of the outer sleeve. The indicator rod can be visible through first and second indicator windows in the upper portion when the core sleeve is in the initial position. In such embodiments, the core sleeve can be configured to slide between the indicator rod and the upper portion of the outer sleeve such that when the core sleeve is in the first actuated position, the core sleeve blocks the first indicator window, thereby indicating the release of a first simulated dose of the drug. In certain embodiments, the core sleeve can block the first and second indicator windows when the core sleeve is in the second actuated position, thereby indicating the release of a second simulated dose of the drug.

[0015] In some embodiments, the training device can include a protective sanitary cap that can be selectively matable with and removable from the outer sleeve.

[0016] The first and second sets of locking features can have various configurations. For example, in some embodiments, the first set of locking features can each include first and second flanges extending from the outer surface of the core sleeve and a first locking groove defined therebetween, where the first locking groove can be configured to retain the core sleeve in the first actuation position. The second set of locking features can each include third and fourth flanges extending from the outer surface of the core sleeve and a second locking groove defined therebetween, where the second locking groove can be configured to retain the core sleeve in the second actuation position. In certain embodiments, the locking sleeve can include at least two snap arms, each having a protrusion extending from its inner surface toward the core sleeve, where each protrusion can be configured to engage with the first locking groove when the core sleeve is in the first actuation position and can be configured to engage with the second locking groove when the core sleeve is in the second actuation position.

[0017] In some embodiments, the plunger can return to the starting position after application of the first actuation force and after application of the second actuation force.

[0018] In another exemplary embodiment, a training device is provided including an outer sleeve having an upper portion and a lower portion, a locking sleeve coupled to the outer sleeve and extending partially through the outer sleeve, a core sleeve coupled to the locking sleeve and configured to slide axially within the outer sleeve and the locking sleeve, and a plunger operably coupled to the core sleeve, the plunger configured to translate axially relative to the outer sleeve to selectively slide the core sleeve in a first axial direction from a start position to a first axial position and from the first axial position to a second axial position, the plunger further configured to rotate relative to the outer sleeve between an initial position and an actuated radial position, wherein when the core sleeve is in the second axial position, rotation of the plunger from the initial position to the actuated radial position resets the core sleeve to the start position such that the core sleeve can translate axially back to the first and second axial positions.

[0019] In some embodiments, the training device includes a protective sanitary cap that is selectively mateable with and removable from the device.

[0020] In other embodiments, the core sleeve can be configured to be repeatedly reset.

[0021] In some embodiments, the training device can include a first biasing element capable of biasing the plunger to an initial position until a rotational force is applied to the plunger that overcomes the rotational biasing force of the first biasing element, thereby rotating the plunger in a first rotational direction. Release of the rotational force can allow the first biasing element to rotate the plunger in a second, opposite rotational direction, allowing the plunger to return to the initial position. In certain embodiments, the training device can include a second biasing element capable of biasing the core sleeve to the start position until an axial force is applied to the core sleeve that overcomes the axial biasing force of the second biasing element, thereby translating the core sleeve in a first axial direction. In yet other embodiments, when the core sleeve is in the second axial position, rotation of the plunger in a first rotational direction can rotate the core sleeve and disengage it from the locking sleeve. Furthermore, when the core sleeve is disengaged from the locking sleeve, the second biasing element can urge the core sleeve in a second, opposite axial direction from the second axial position toward the start position. Further, the release of the rotational force can enable the first biasing element to rotate the plunger in a second, opposite rotational direction until the plunger reaches the initial position, and rotation of the plunger in the second rotational direction can rotate the core sleeve back to the starting position.

[0022] A method for simulating intranasal drug delivery is also provided. In one exemplary embodiment, the method includes depressing a plunger operably coupled to a core sleeve of a training device, axially translating the core sleeve in a first axial direction from a start position to a first actuation position, the first actuation position being associated with completion of release of a first simulated dose of the drug; depressing the plunger to axially translate the core sleeve in the first axial direction from the first actuation position to a second actuation position, the second actuation position being associated with completion of release of a second simulated dose of the drug; and rotating the plunger, resetting the core sleeve to the start position, thereby allowing the core sleeve to axially translate back to the first and second actuation positions, wherein the device does not contain the drug.

[0023] In some embodiments, the method can include inserting a portion of the device into a first nostril when the core sleeve is in a start position and before depressing the plunger. In such embodiments, the method can include removing the device from the first nostril and inserting a portion of the device into a second nostril when the core sleeve is in a first actuated position and before depressing the plunger.

[0024] In some embodiments, rotating the plunger can include applying a rotational force to the plunger, rotating the plunger in a first rotational direction, thereby moving the plunger from the initial radial position to the actuated radial position, and releasing the rotational force, rotating the plunger in a second, opposite radial direction, allowing it to return to the initial radial position.

[0025] In some embodiments, an indicator rod located within the outer sleeve of the training device may be visible through first and second indicator windows in the outer sleeve prior to depression of the plunger. In such embodiments, depressing the plunger to axially translate the core sleeve to a first actuated position may translate the core sleeve distally between the indicator rod and the outer sleeve, thereby blocking the indicator rod from being visible through the first indicator window to indicate completion of release of a first simulated dose of drug. In such embodiments, depressing the plunger to axially translate the core sleeve to a second actuated position may further translate the core sleeve distally between the indicator rod and the outer sleeve, thereby blocking the indicator rod from being visible through the first and second indicator windows to indicate completion of release of a second simulated dose of drug. In such embodiments, rotating the plunger may translate the core sleeve proximally between the indicator rod and the outer sleeve, thereby unblocking the first and second indicator windows so that the indicator rod is visible therethrough to indicate that the core sleeve is reset. [Brief explanation of the drawings]

[0026] The present invention will be more fully understood from the following detailed description when read in conjunction with the accompanying drawings, in which: [Figure 1A] FIG. 1 is an isometric view of one embodiment of a training device. [Figure 1B] FIG. 1B is a top orthographic view of the training device of FIG. 1A. [Figure 1C] FIG. 1B is a bottom orthographic view of the training device of FIG. 1A. [Figure 1D] FIG. 1B is a partially exploded view of the training device of FIG. 1A. [Figure 2A] 2 is a cross-sectional view of the training device of FIG. 1A taken at 2-2. [Figure 2B]FIG. 2B is an enlarged cross-sectional view of a portion of the training device of FIG. 2A. [Figure 3A] FIG. 1B is a side orthographic view of the core sleeve of the device of FIG. 1A. [Figure 3B] FIG. 1B is another side orthographic view of the core sleeve of the device of FIG. 1A. [Figure 4] FIG. 1B is a side orthographic view of the plunger of the device of FIG. 1A. [Figure 5] FIG. 5 is a bottom view of the plunger of FIG. 4. [Figure 6A] 1B is the device of FIG. 1A in a starting position, showing the core sleeve and plunger, each in their initial positions. [Figure 6B] 6B is the device of FIG. 6A during a first stage of operation, showing the core sleeve in a first actuated position corresponding to the release of a first simulated drug. [Figure 6C] 6C is the device of FIG. 6B at the end of the first operating stage, showing the return of the plunger to its initial position when the core sleeve is in the first actuated position. [Figure 6D] 6B is the device of FIG. 6A during a second operating stage subsequent to the first operating stage, showing the core sleeve in a second actuated position corresponding to the release of a second simulated drug. [Figure 6E] 6D at the end of a second operating stage, showing the core sleeve in the actuated position and the plunger returning to its initial position. [Figure 7A] 6B is the device of FIG. 6A in a third stage of operation following the second stage of operation, showing the plunger rotating toward the actuated radial position and the core sleeve disengaging from the locking sleeve and axially translating toward its initial position. [Figure 7B] 6B is the device of FIG. 6A in a third stage of operation, further rotated and showing the plunger in its actuated radial position. [Figure 7C] 6B is the device of FIG. 6A at the end of a third operating phase, showing the return of the plunger and core sleeve to their initial positions and the device reset to its starting position. [Figure 8]FIG. 10 is an isometric view of another embodiment of a training device. [Figure 9A] FIG. 9 is an isometric view of the device of FIG. 8 showing a protective sanitary cap coupled thereto. [Figure 9B] FIG. 9B is a partially exploded view of the device of FIG. 9A. DETAILED DESCRIPTION OF THE INVENTION

[0027] Certain exemplary embodiments are described below to provide a general understanding of the principles of the structure, function, manufacture, and use of the training devices disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the training devices specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments, and that the scope of the invention is defined only by the claims. Features illustrated or described in connection with one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be within the scope of the present invention.

[0028] Various training devices and methods are provided for simulating intranasal drug administration without delivering a drug to a user. As discussed in more detail below, unlike intranasal drug delivery devices, the training devices do not contain any drug. These devices are structurally configured to mimic multiple aspects of using an intranasal drug delivery device. The training devices are also designed for repeated use by either a single user or multiple users. As a result, before using an intranasal drug delivery device, a user can use these training devices to learn and become familiar with the operational steps and proper techniques required to effectively use the intranasal drug delivery device.

[0029] The training device generally includes an outer sleeve, a locking sleeve, a core sleeve, and a plunger. As discussed in more detail below, the plunger selectively translates the core sleeve to a first actuation position associated with the release of a first simulated dose of drug and to a second actuation position associated with the release of a second simulated dose of drug. The release of the first and second simulated doses corresponds to the release of a first and second dose of drug, respectively, from an intranasal drug delivery device. As a result, positioning and actuating the training device provides the user with a tactile experience similar to positioning and actuating an intranasal drug delivery device. Furthermore, repeated use of the training device allows the user to develop a degree of muscle memory, which can be useful in developing proper usage techniques for an intranasal drug delivery device. Thus, these training devices provide users with the ability to practice, thereby familiarizing them with the operational steps required to properly use an intranasal drug delivery device to optimize drug delivery and drug effectiveness, while also reducing waste and user anxiety.

[0030] Generally, the training devices described herein are designed to perform a three-stage operation without expelling any drug to the user. The first and second operation stages involve two separate actuations of the device, one corresponding to a first simulated dose of drug and the other corresponding to a second simulated dose of drug. These two separate actuations are similar in configuration, device positioning, and device actuation used to release drug from a dual-dose intranasal drug delivery device. Furthermore, unlike dual-dose intranasal drug delivery devices, the training devices are designed for multiple uses rather than a single use, and therefore include a third operation stage for resetting the device for a subsequent simulated dose, either by the same user or a different user. Specifically, the training device includes a reset mechanism that can be activated after completion of the second operation stage to reset the device. As a result, a user can repeatedly use the training device to simulate intranasal drug delivery without expelling any drug. Non-limiting exemplary embodiments of other suitable dual dose intranasal drug delivery devices are described in more detail in U.S. Pat. Nos. 9,555,950, 7,299,949, and 6,321,942, each of which is incorporated herein by reference in its entirety.

[0031] An exemplary training device may include various features to facilitate simulation of intranasal drug delivery of a drug from a dual-dose intranasal drug delivery device, as described herein and illustrated in the drawings. However, one skilled in the art will recognize that a training device may have only some of these features and / or may have various other features known in the art. The training devices described herein are intended only to represent certain exemplary embodiments.

[0032] 1A-2B illustrate an exemplary embodiment of a training device 100 configured to simulate intranasal drug delivery. Device 100 includes an outer sleeve 102, a depth guide 104, a finger rest 106, a locking sleeve 108, a core sleeve 110, and a plunger 112.

[0033] While the outer sleeve 102 can have a variety of configurations, as shown in FIG. 1D , the outer sleeve 102 includes upper and lower segments 114a, 114b. The upper and lower segments 114a, 114b each have a cylindrical configuration. As shown, the upper segment 114a culminates in a tip 115. The tip 115 is configured to be inserted into a first nostril during a first operational phase of the device 100 and into a second nostril during a second operational phase of the device 100. In other embodiments, the upper and lower segments 114a, 114b can have other suitable structural configurations.

[0034] As shown in FIGS. 1A, 1D, and 2A-2B, the upper segment 114a of the outer sleeve 102 includes an indicator frame 116 surrounding two indicator windows 118a, 118b. In this illustrated embodiment, the indicator frame 116 has an oval configuration, and the two indicator windows 118a, 118b each have a circular configuration. In other embodiments, the indicator frame 116 and the two indicator windows 118a, 118b can have other suitable geometric configurations. As further shown in FIGS. 1D and 2A-2B, an indicator rod 120 is disposed within the outer sleeve 102 and extends partially through the upper segment 114a so as to overlap the two indicator windows 118a, 118b. As described in more detail below, the indicator rod 120 is visible through the two indicator windows 118a, 118b prior to activation of the device 100. That is, visibility of indicator rod 120 through both of these indicator windows 118a, 118b indicates to the user that device 100 is in the starting position. Furthermore, in some embodiments, indicator rod 120 can have a first color that is different from the color of upper segment 114a of outer sleeve 102 to enhance visibility of indicator rod 120 through indicator windows 118a, 118b. For example, before any activation and when device 100 is ready for use, indicator windows 118a, 118b can exhibit a color such as green. After a first activation, indicator window 118a can exhibit a different color, such as white, and after a second activation, indicator window 118b can exhibit a white color as well.

[0035] 1A, 1D, and 2A-2B, the depth guide 104 is joined to the finger rest 106 via the elongated tubular body 122. The depth guide 104 includes a first set of opposing flanges 124a, 124b extending from a first end 122a of the elongated tubular body 122. The first set of opposing flanges 124a, 124b are configured to limit the insertion depth of the upper segment 114a of the outer sleeve 102 into the user's nostrils. The finger rest 106 includes a second set of two opposing flanges 126a, 126b extending from a second opposing end 122b of the elongated tubular body 122. The finger rest 106 serves as a positioning guide for the user's fingers, e.g., the user's index and middle fingers, so that the user can grasp and hold the device 100 while using their thumb to depress the plunger 112 toward the upper segment 114a of the outer sleeve 102. The elongated tubular body 122 includes an oval hole 128 that corresponds to the indicator frame 116 of the upper segment 114a of the outer sleeve 102. Thus, when the elongated tubular body 122, and therefore the depth guide 104 and finger rest 106, are positioned around a portion of the upper segment 114a of the outer sleeve 102, as shown in FIG. 1A , the indicator frame 116 extends through the oval hole 128 of the elongated tubular body 122 to maintain its position.

[0036] The locking sleeve 108 has an annular collar 130 coupled between the upper and lower segments 114a, 114b of the outer sleeve 102, thereby forming a shoulder 132. This coupled engagement holds the locking sleeve 108 in a fixed position within the outer sleeve 102. The locking sleeve 108 also includes snap arms 134 that extend proximally from the annular collar 130 and partially through the lower segment 114b of the outer sleeve 102. In this illustrated embodiment, the number of snap arms 134 can vary, but the locking sleeve 108 is aligned with the longitudinal axis (L) of the device 100. A) and equally distributed therearound. Each snap arm 134 includes an inward protrusion 136, only one of which is shown, configured to engage a locking feature on the core sleeve 110. Thus, the snap arms 134 can simultaneously flex outward as the conical profile presses upward toward the upper segment 114a of the outer sleeve 102 and over the inward protrusion 136.

[0037] 1D and 2A-2B, each protrusion 136 includes at least an angled surface 136a and a flat surface 136b. The surface of the flat surface 136b extends perpendicular to the longitudinal axis of the device 100. As discussed in more detail below, the angled surface 136a of each protrusion 136 is configured to slide over flanges (such as second, third, and fourth flanges 144, 150, and 152) on the core sleeve 110 during first and second stages of operation that allow axial translation of the core sleeve 110 relative to the locking sleeve 108, and the flat surface 136b is configured to engage locking grooves (such as first, second, and third locking grooves 146, 154, and 160) on the core sleeve to further lock the core sleeve in various positions.

[0038] As shown in FIGS. 1D and 2A-2B and in more detail in FIGS. 3A and 3B, the core sleeve 110 extends from an open end 110a to a closed end 110b. A first biasing element 138 is held between and compressed at the closed end 110b of the core sleeve 110 and the end 120a of the indicator rod 120. While the first biasing element 138 can have a variety of configurations, in this illustrated embodiment, the first biasing element 138 is a helical spring. The core sleeve 110 includes a first set of locking features 140. The first set of locking features 140, combined with partial compression of the first biasing element 138, couples the core sleeve to the locking sleeve 108. Thus, the first biasing element 138 is configured to bias the core sleeve 110 to its initial position. As used herein, the term "initial position" is used synonymously with the term "start position."

[0039] The first set of locking features 140 is positioned proximal to the open end 110a of the core sleeve 110. In this illustrated embodiment, the core sleeve 110 is substantially similar in structural configuration and includes three first set of locking features 140 configured to engage with corresponding protrusions 136 on one of the snap arms 134 of the locking sleeve 108. Therefore, for brevity, the following discussion will relate to one of the first set of locking features 140. However, those skilled in the art will understand that the following discussion is also applicable to the remaining first set of locking features 140. Furthermore, in other embodiments, the core sleeve 110 can include fewer or more than three first set of locking features 140.

[0040] While first set of locking features 140 can have a variety of structural configurations, as shown in Figures 2A-3B, first set of locking features 140 includes first and second flanges 142, 144 extending from outer surface 111a of core sleeve 110 and a first locking groove 146 defined therebetween. As shown, first and second flanges 142, 144 each include at least angled surfaces 142a, 144a and flat surfaces 144a, 144b. Flat surfaces 144a, 144b extend in a direction perpendicular to the longitudinal axis of device 100. Thus, core sleeve 110 is held in its starting position by first set of locking features 140 interacting with protrusion 136 of locking sleeve 108. That is, after the device 100 is assembled, the protrusion 136 of the locking sleeve 108 engages with the first locking groove 146 defined between the first flange 142 and the second flange 144 and is maintained in that position until the user activates the device 100 during the first operating stage.

[0041] Additionally, the sloped surface 142a of the second flange 144 has a sloped profile that is structurally designed such that, during use, the sloped profile presses the snap arms 134 outward, at which point a certain amount of force must be applied to the core sleeve 110 before the core sleeve 110 can move freely toward the distal end 115 of the device 100 and into the first actuation position. That is, the axial force applied to the core sleeve 110 (first actuation force) must exceed a first force threshold to allow the core sleeve 110 to translate axially via the plunger 112 to the first actuation position. This first force threshold corresponds to a first atomization threshold for releasing a first simulated dose of drug from the intranasal drug delivery device. In one embodiment, the sloped profile can be manipulated to match ±20% of the first atomization threshold of the intranasal drug delivery device.

[0042] The core sleeve 110 can include additional sets of locking features. For example, as shown in FIGS. 1D and 2A-2B, the core sleeve 110 includes a second set of locking features 148 that maintain the core sleeve 110 in the first actuated position, as will be discussed in more detail. In this illustrated embodiment, the core sleeve 110 is substantially similar in structural configuration and includes three second sets of locking features 148 configured to engage with corresponding protrusions 136 on one snap arm 134 of the locking sleeve 108. Therefore, for brevity, the following discussion will be directed to one of the second sets of locking features 148. However, one skilled in the art will understand that the following discussion is also applicable to the remaining second sets of locking features 148. Furthermore, in other embodiments, the core sleeve 110 can include fewer or more than three second sets of locking features 148.

[0043] While the second set of locking features 148 can have a variety of structural configurations, as shown in FIGS. 2A-3B , the second set of locking features 148 includes third and fourth flanges 150 and 152 extending from the outer surface 111 a of the core sleeve 110 and a second locking groove 154 defined therebetween. As shown, the third flange 150 and the fourth flange 152 each include at least an inclined surface 150 a, 152 a and a flat surface 150 b, 152 b. The flat surfaces 150 b, 152 b are aligned with the longitudinal axis (L ) of the device 100. A ) and extend perpendicular to the first flange 150. Thus, core sleeve 110 is held in the first actuation position by the second set of locking features 148 that interact with protrusions 136 of locking sleeve 108. That is, protrusions 136 of locking sleeve 108 engage second locking grooves 154 defined between third flange 150 and fourth flange 152, and are maintained in that position until a user actuates device 100 during a second operating stage.

[0044] The sloped surface 150a of the third flange 150 has a smaller slope profile than the sloped profile of the sloped surface 144a of the second flange 144. The smaller diameter of this sloped profile ensures that the user does not need to apply increased force to the core sleeve 110 to slide over the sloped surface 150a of the third flange 150. That is, a first actuation force is sufficient to slide the core sleeve 110 from its initial position to its first actuation position.

[0045] Additionally, the sloped surface 152a of the fourth flange 152 has a sloped profile that is structurally designed such that, during use, the sloped profile presses the snap arms 134 outward, at which point a certain amount of force must be applied to the core sleeve 110 before the core sleeve 110 can move freely and further toward the distal end 115 of the device 100 to the second actuation position. That is, the axial force applied to the core sleeve 110 (the second actuation force) must exceed a second force threshold to allow the core sleeve 110 to be axially translated to the second actuation position via the plunger 112. This second force threshold corresponds to a second atomization threshold for releasing a first simulated dose of drug from the intranasal drug delivery device. In some embodiments, the second force threshold can be the same as the first force threshold, while in other embodiments, the second force threshold can be either greater than or less than the first force threshold. For example, in one embodiment, the second force threshold is greater than the first force threshold. In one embodiment, the ramp profile can be manipulated to match the second nebulization threshold of the intranasal drug delivery device ±20%.

[0046] The core sleeve 110 can also include a third set of locking features 156 that maintain the core sleeve 110 in the second actuated position, as will be discussed in more detail. In this illustrated embodiment, the core sleeve 110 is substantially similar in structural configuration and includes three third set of locking features 156 configured to engage corresponding protrusions on one of the snap arms 134 of the locking sleeve 108. Therefore, for brevity, the following discussion will be directed to one of the third set of locking features 156. However, those skilled in the art will understand that the following discussion is also applicable to the remaining third set of locking features 156. Furthermore, in other embodiments, the core sleeve 110 can include fewer or more than three third set of locking features 156.

[0047] While the third set of locking features 156 can have a variety of structural configurations, as shown in FIGS. 2A-3B , the third set of locking features 156 includes a fourth flange 152, a fifth flange 158 extending from the outer surface 111 a of the core sleeve 110, and a third locking groove 160 defined therebetween. As shown, the fifth flange 158 also includes at least an angled surface 158 a and a flat surface 158 b. The flat surface 158 b is aligned with the longitudinal axis (L ) of the device 100. A ) and extends perpendicular to the third set of locking features 156. Thus, core sleeve 110 is held in the second actuation position by third set of locking features 156 that interact with protrusions 136 of locking sleeve 108. That is, protrusions 136 of locking sleeve 108 engage third locking grooves 160 defined between fourth flange 152 and fifth flange 158, and are maintained in that position until a user resets device 100 during a third operating stage.

[0048] 2A-2B, the plunger 112 is operably coupled to the core sleeve 110 and is configured to translate axially relative to the outer sleeve 102 to selectively slide the core sleeve 110 from its starting position to its first actuated position and from its first actuated position to its second actuated position during the first and second stages of operation of the device 100, respectively. The plunger 112 is also configured to rotate relative to the outer sleeve 102 between the initial radial position and the actuated radial position to reset the device 100 after completion of the second stage of operation. While the plunger 112 can have a variety of configurations, in this illustrated embodiment, the plunger 112 has an elongated tubular configuration extending from a first end 162a to a second end 162b. The plunger 112 also includes three equally spaced cantilever arms 164, as shown in FIG. 5. Cantilever arms 164, two of which are closed in Figures 2A-2B, are disposed radially from a first end 162a of the plunger 112 and extend toward the core sleeve 110. The plunger 112 can also include gripping features 163 to assist in rotation of the plunger 112, as shown in Figures 1A, 2A-2B, and 4.

[0049] A second biasing element 166 is partially seated within the lower segment 114b of the outer sleeve 102, which surrounds the lock and core sleeves 108, 110. While the second biasing element 166 can have a variety of configurations, in this illustrated embodiment, the second biasing element 166 is a helical spring. Ends 166a, 166b of this second biasing element 166 are each oriented along the longitudinal axis (L) of the device 100. A ) As shown, first end 166a interacts with shoulder 132 formed by annular collar 130 of locking sleeve 108 and upper and lower segments 114a, 114b of outer sleeve 102 such that second biasing element 166 cannot freely rotate about the longitudinal axis of device 100.

[0050] As shown in FIGS. 2A-2B, the plunger 112 is engaged with and partially compressed by the second biasing element 166. Although not shown, during assembly, the second end 166b of the second biasing element 166 engages a rib on the inner surface 113a of the plunger 112. As a result, when the plunger 112 is engaged with the second biasing element 166, it is forced to rotate relative to the longitudinal axis (L) of the device 100. A ), thereby applying a twist to second biasing element 166. Second biasing element 166 therefore biases plunger 112 to the initial radial position, as shown in FIGS. 2A-2B.

[0051] Additionally, the plunger 112 is partially seated within the lower segment 114b of the outer sleeve 102 and coupled thereto by a locking ring 168. As shown in more detail in FIG. 4, the plunger 112 includes three equally spaced lugs 169 on the outer surface 113b of the plunger 112 and positioned at the second end 112b of the plunger 112. Each of the three lugs 169 has an L-shaped configuration (see FIG. 4). As further shown in FIG. 5, the plunger 112 also includes three equally spaced, axially aligned rib features 165 on the inner surface 113a of the plunger 112. These rib features 165 are configured to engage corresponding rib features 171 on the core sleeve 110 such that the plunger 112 and core sleeve 110 rotate together during a portion of the third stage of operation. As discussed below, this engagement allows the core sleeve 110 to disengage from and rotate relative to the locking sleeve 108 during a portion of the third stage of operation.

[0052] The plunger 112 is partially seated within the lower segment 114b of the outer sleeve 102, such that three lugs 169 are positioned within corresponding axially aligned channels 117, two of which are shown in FIG. 2A on the inner surface of the lower segment 114b of the outer sleeve 102. As a result, during use, the plunger 112 can be depressed axially when the second biasing element 166 is compressed, such that the three lugs 169 extend along the channels 117. Furthermore, when the plunger 112 is in its initial radial position, it can be rotated to a limited extent in a first rotational direction, thereby applying additional torque to the second biasing element 166. Thus, the second biasing element 166 serves the dual purpose of returning the plunger 112 axially after each depression during the first and second stages of device operation, and also returning it radially after rotation during the third stage of device operation.

[0053] As described above, the training device 100 has three stages of operation, the first stage of operation illustrated in Figures 6A-6C, the second stage of operation illustrated in Figures 6D and 6E, and the third stage of operation illustrated in Figures 7A-7C. Generally, the first stage of operation involves axial translation of the core sleeve 110 to mimic a first spray of drug from the intranasal drug delivery device, the second stage of operation involves further axial translation of the core sleeve 110 to mimic a second spray of drug from the intranasal drug delivery device, and the third stage of operation involves rotation of the plunger 112 to axially reset the device 100, and thus the core sleeve 110, to its starting position for reuse. Each stage of operation is described in more detail below.

[0054] Although not shown, before the first operation stage, the user may adjust the longitudinal axis (L A Insert the tip 115 of the outer sleeve 102 into your first nostril until the depth guide 104 contacts your skin between your first and second nostrils, such that the depth guide 104 is aligned with the axis of your first nostril. Additionally, prior to insertion, in some embodiments, the user can tilt their head approximately 45 degrees relative to their neck.

[0055] During the first stage of operation, the user applies a first actuation force to the first end 112a of the plunger 112 in the axial direction (A1) toward the upper segment 114a of the outer sleeve 102. The user may apply this force to their thumb, opposite their finger on the finger rest 106. This applied force initially presses the cantilever arm 164 of the plunger 112 against the flat surface 158b of the fifth flange 158 on the core sleeve 110. When the applied force exceeds a first threshold force, the plunger 112 axially translates the core sleeve 110 from its starting position (FIG. 6A), and the protrusion 136 of the locking sleeve 108 engages with the first locking groove 146 of the core sleeve 110 to a first actuation position (FIGS. 6B and 6C), where the protrusion 136 of the locking sleeve 108 engages with the second locking groove 154 of the core sleeve 110. This applied force therefore causes the protrusion 136 of the locking sleeve 108 to slide along the second and third flanges 144, 150 and snap into engagement with the second locking groove 154 of the core sleeve 110. As a result, the first biasing element 138 is further compressed from the initial compressed position (FIG. 6A) to the first compressed position (FIGS. 6B and 6C).

[0056] Furthermore, during this translation, the core sleeve 110 slides between the indicator rod 120 and the upper segment 114a of the outer sleeve 102. As a result, when the core sleeve 110 is in the first actuated position (FIGS. 6B and 6C), the core sleeve 110 blocks the first indicator window 118a, thereby indicating the release of the first simulated dose of drug. Once the core sleeve 110 reaches its first actuated position, the user can release the plunger 112 and allow the second biasing element 166 to push the plunger 112 in the reverse axial direction (A2) back to its starting position (FIG. 6C). As the plunger 112 returns to its starting position, the three cantilever arms 164 overcome a set of three angled protrusions 170 on the lower section 172 of the core sleeve 110.

[0057] Although not shown, before the second operation stage, the user removes the tip 115 from their first nostril and rotates the longitudinal axis (L A Insert the tip 115 of the outer sleeve 102 into your second nostril until the depth guide 104 contacts the skin between your first and second nostrils, such that the depth guide 104 is aligned with the axis of the second nostril. Additionally, prior to insertion, in some embodiments, the user can tilt their head approximately 45 degrees relative to their neck (e.g., 45 degrees back from the user's vertical).

[0058] During the second actuation phase, the user applies a second actuation force to the first end 112a of the plunger 112 in the axial direction (A1) toward the upper segment 114a of the outer sleeve 102. The user may apply this force to their thumb, opposite their finger on the finger rest 106. This applied force initially presses the cantilever arm 164 of the plunger 112 against the three angled protrusions 170 on the core sleeve 110. When the second applied force exceeds a second threshold force, the plunger 112 axially translates the core sleeve 110 from its first actuation position (FIGS. 6B and 6C), and the protrusion 136 of the locking sleeve 108 engages with the second locking groove 154 of the core sleeve 110 to a second actuation position (FIG. 6D), and the protrusion 136 of the locking sleeve 108 engages with the third locking groove 160 of the core sleeve 110. This applied force therefore causes protrusion 136 of locking sleeve 108 to slide along fourth flange 152 and snap into engagement with third locking groove 160. As a result, the first biasing element is further compressed from its first compressed position (FIGS. 6B and 6C) to a second compressed position (FIGS. 6D and 6E).

[0059] Furthermore, during this translation, the core sleeve 110 further slides between the indicator rod 120 and the upper segment 114a of the outer sleeve 102. As a result, when the core sleeve 110 is in the second actuated position, the core sleeve 110 blocks both the first and second indicator windows 118a, 118b such that the indicator rod 120 is not visible. This indicates the completion of the second simulated dose of medication and, therefore, both simulated doses. Once the core sleeve 110 reaches its second actuated position, the user can release the plunger 112 and allow the second biasing element 166 to push the plunger 112 in the reverse axial direction back to its starting position (FIG. 6E).

[0060] Once the outer sleeve 102 is removed from the second nostril, the user can perform a third actuation phase, which resets the device 100. With the core sleeve 110 in the second actuation position, the plunger 112 rotates relative to the outer sleeve 102, and thus relative to the torque of the second biasing element 166, along the longitudinal axis (L) of the device 100. A ) (e.g., in a clockwise direction when viewed from the first end 162a of the plunger 112).

[0061] During the third operating phase, in which the core sleeve 110 begins in the second operating position, the longitudinal axis (L A) can reset the core sleeve 110 to a starting position such that the core sleeve 110 can be axially translated back to the first and second actuated positions. In this illustrated embodiment, the actuated radial position of the plunger 112 can be achieved by rotating the plunger 112 a certain amount, such as approximately 120 degrees, from its initial radial position. In other embodiments, the actuated radial position of the plunger 112 can be achieved by rotating the plunger 112 approximately 90 degrees, or an amount between 90 and 120 degrees, from its initial radial position. Those skilled in the art will understand that any amount of rotation for rotating the plunger 112 from its initial radial position to its actuated radial position may be possible and may depend at least on the structural configurations of the locking sleeve 108, the core sleeve 110, and the plunger 112.

[0062] During the third stage of operation, a rotational force exceeding the rotational biasing force (torque) of the second biasing element 166 is applied to the plunger 112, thereby rotating the plunger 112 from its initial radial position to its actuated radial position in a first rotational direction (e.g., clockwise) relative to the outer sleeve 102 as viewed from the first end of the plunger 112. After the first degree of rotation (e.g., approximately 40 degrees) of the plunger 112 toward its actuated radial position ( FIG. 7A ), the cantilever arm 164 rotates into axial alignment with the fifth flange 158 and three angled protrusions 170 on the core sleeve 110. Also at this rotation point, the three rib features 165 (see FIG. 5 ) of the plunger 112 contact three rib features 171 (see FIGS. 3A-3B ) on the core sleeve 110. As a result, plunger 112 and core sleeve 110 simultaneously rotate through a second degree of rotation (e.g., approximately 50 degrees) until plunger 112 reaches its actuated radial position (FIG. 7B). During this second degree of rotation, core sleeve 110 rotates relative to locking sleeve 108 such that protrusion 136 of locking sleeve 108 moves into axially aligned channel 173 (see FIGS. 3A-3B) on core sleeve 110. This allows first biasing element 138 to urge core sleeve 110 back in the second axial direction toward its starting position. At this point, indicator rod 120 is now visible through both indicator windows 118a, 118b in upper segment 114a of outer sleeve 102. When the plunger 112 is released, the second biasing element 166 rotates the plunger 112 in a second, opposite rotational direction such that the plunger 112 returns to its initial radial position and, during this rotation, the plunger rotates the core sleeve 110 back to its starting position (FIG. 7C).

[0063] In some embodiments, the indicator rod 120 may be a different color than the core sleeve 110 to assist the user in visually verifying the position of the core sleeve 110. That is, the difference in color between the indicator rod and the core sleeve may help to visually indicate to the user that the core sleeve is in the start position, the first actuated position, and the second actuated position.

[0064] Once the user becomes familiar with using the training device 100, the training device 100 can be disposed of. Thus, the training device 100 is configured to be used multiple times by a single user. In other embodiments, the training device 100 can be configured to be used multiple times by multiple users.

[0065] FIG. 8 illustrates another exemplary embodiment of a training device 800 that can be used multiple times by multiple users. The training device 800 is structurally and operationally similar to the training device 100 of FIGS. 1A-7C , except that the upper segment 814 a of the outer sleeve 802 extends to a shortened tip 815. As shown in FIG. 8 , this shortened tip 815 does not extend beyond the depth guide 804, and thus, during use, the shortened tip 815 is not inserted into any of the user's nostrils. Instead, prior to a first operational phase, the user can position the device 800 on a first side of their head with their hands and wrists in a similar position as if the shortened tip 815 were positioned in their first nostril. That is, the user can place device 800 on a first side of their head with shortened tip 815 laterally aligned with the location of their first nostril and depth guide 804 laterally aligned with the location of their skin between their first and second nostrils. Similarly, prior to the second operational step, the user can position device 800 on a second side of their head with their hand and wrist in a similar position as if shortened tip 815 were positioned at their second nostril. That is, the user can place device 800 on the second side of their head with shortened tip 815 laterally aligned with the location of their second nostril and depth guide 804 laterally aligned with the location of their skin between their first and second nostrils. Once the user is familiar with the operational steps of device 800, device 800 can be returned to a healthcare provider who can clean it (e.g., using a sterile alcohol wipe or the like) and store it for the next user.

[0066] 9A and 9B illustrate another exemplary embodiment of a training device 900 that can be used multiple times by multiple users. Training device 900 is structurally and operationally similar to training device 800, except that device 900 includes a protective sanitary cap 990 that is selectively engageable with and removable from device 900. Prior to use of device 900, protective sanitary cap 990 can be placed over and engaged with tip 915 of training device 900 such that tip 915, depth guide 904, and finger rest 906 are protected by cap 990. Cap 990 includes two snap arms 992, 994 configured to snap into position over ends 995 a, 995 b of opposing flanges 926 a, 926 b of finger rest 906, thereby securing the cap to device 900.

[0067] As further shown, cap 990 includes a tip 996 that shares the same profile as tip 115 of training device 100 shown in FIGS. 1A-7C , such that when cap 990 is coupled to finger rest 906, tip 996 can be similarly inserted into a user's nostrils, as discussed above. Thus, when the cap is coupled to device 900, a user can perform all operational steps of device 900, including insertion into the nostrils. However, in this illustrated embodiment, training device 900 itself remains free of contact with the user's nose and fingertips, and thus device 900 remains hygienically clean. Once the user is sufficiently comfortable with the positioning and actuation process of training device 900, the medical care provider can remove and dispose of cap 990 before storing training device 900 for subsequent use by a different user.

[0068] Additionally, the training device may be provided with two or more protective sanitary caps 990. In such an embodiment, once all caps are used up, the device can be disposed of and replaced with a corresponding protective sanitary cap. As a result, deterioration of the device's actuation mechanism can be managed by the number of caps supplied with the device. This can prevent the use of overused devices that do not provide adequate tactical experience during use. Furthermore, the use of protective sanitary caps allows fewer devices to be used and disposed of compared to those without protective sanitary caps.

[0069] Although the sanitary cap 990 is described primarily with respect to the embodiment of Figures 8-9B, one skilled in the art will understand that the sanitary cap 990 can likewise be used with the embodiment of Figures 1-7C, with any modifications that ensure proper fit of the sanitary cap 990.

[0070] The devices disclosed herein can be formed from one or more polymers known to those skilled in the art, such as polycarbonate. In some embodiments, the first and second biasing elements can be formed from one or more metals, such as spring steel.

[0071] The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular parts, and subsequent reassembly. Specifically, the device can be disassembled, and any number of particular parts or portions of the device can be selectively replaced or removed in any combination. Upon cleaning and / or replacement of particular parts, the device can be reassembled for subsequent use at a reconditioning facility, or by a medical care provider immediately prior to use. Those skilled in the art will appreciate that a variety of techniques for disassembly, cleaning / replacement, and reassembly are available for the reconditioning of a device. The use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.

[0072] Furthermore, in this disclosure, like-named components of embodiments generally have similar characteristics, and therefore, in particular embodiments, every feature of each like-named component will not necessarily be described in full detail. Additionally, to the extent that linear or circular dimensions are used in describing the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. Those skilled in the art will recognize that equivalent dimensions to such linear and circular dimensions can be readily determined for any geometric shape. The size and shape of the systems and devices and their components may depend, at least, on the anatomical structure of the subject within which the systems and devices are to be used, the size and shape of the components with which the systems and devices are to be used, and the method and procedure for which the systems and devices are to be used.

[0073] It will be understood that the terms "proximal" and "distal" are used herein with reference to the portion of the device where a user grips the plunger. Other spatial terms, such as "forward" and "rearward," similarly correspond to distal and proximal, respectively. It will further be understood that for convenience and clarity of explanation, spatial terms such as "vertical" and "horizontal" are used herein with respect to the drawings. However, the device is used in many orientations and positions, and these spatial terms are not intended to be limiting or absolute.

[0074] Values ​​or ranges can be expressed herein as "about" and / or "approximately" from one particular value to another particular value. When values ​​or ranges are so expressed, other disclosed embodiments include the recited particular value and / or from the one particular value to the other particular value. Similarly, when values ​​are expressed in an approximation format by use of the antecedent "about," it will be understood that a number of disclosed values ​​are recited, and that the particular value forms another embodiment. It will be further understood that there are a number of disclosed values, and that each value is herein disclosed as "about" in addition to the particular value itself. In some embodiments, "about" can be used to mean, for example, within 10% of the recited value, within 5% of the recited value, or within 2% of the recited value.

[0075] For purposes of describing and defining the present teachings, unless otherwise indicated, it should be noted that the term "substantially" is utilized herein to represent the inherent degree of uncertainty that may result from any quantitative comparison, value, measurement, or other representation. The term "substantially" is also utilized herein to represent the degree to which a quantitative representation may vary from the stated standard without resulting in a change in the basic functionality of the object in question.

[0076] Those skilled in the art will recognize further features and advantages of the present invention based on the embodiments described above. Accordingly, the present invention is not limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety. Any patent, publication, or information incorporated herein by reference in whole or in part is incorporated herein only to the extent that it does not contradict existing definitions, descriptions, or other disclosure material set forth in this document. Therefore, the disclosure explicitly set forth herein shall take precedence over any conflicting document incorporated herein.

[0077] The following is a non-exhaustive list of embodiments that may be or have been claimed. Embodiment 1. A training device for simulating intranasal drug delivery, comprising: an outer sleeve having an upper portion and a lower portion; a locking sleeve coupled to the outer sleeve and extending partially through the outer sleeve; a core sleeve coupled to the locking sleeve and configured to slide axially within the outer sleeve and the locking sleeve, the core sleeve having first and second sets of locking features; a plunger operably coupled to the core sleeve, the plunger configured to selectively translate the core sleeve from an initial position to a first actuation position in response to application of a first actuation force that exceeds a first force threshold, and the plunger configured to translate the core sleeve from the first actuation position to a second actuation position in response to application of a second actuation force that exceeds a second force threshold; the first force threshold corresponds to a first nebulization threshold for releasing a first simulated dose of the drug, and the second force threshold corresponds to a second nebulization threshold for releasing a second simulated dose of the drug; The device does not contain a drug. Embodiment 2. The device of embodiment 1, further comprising a protective sanitary cap selectively mateable with and removable from the device. Embodiment 3. The device of embodiment 1, wherein the first set of locking features each include first and second flanges extending from the outer surface of the core sleeve and a first locking groove defined therebetween, the first locking groove configured to retain the core sleeve in the first actuated position. Embodiment 4. A device as described in embodiment 3, wherein the second set of locking features each include third and fourth flanges extending from the outer surface of the core sleeve and a second locking groove defined therebetween, the second locking groove being configured to retain the core sleeve in the second actuated position. Embodiment 5. A device as described in embodiment 4, wherein the locking sleeve has at least two snap arms, each having a protrusion extending from its inner surface toward the core sleeve, each protrusion configured to engage with a first locking groove when the core sleeve is in a first operating position, and configured to engage with a second locking groove when the core sleeve is in a second operating position. Embodiment 6. The device of embodiment 1, wherein the plunger returns to a starting position after application of the first actuation force and after application of the second actuation force. Embodiment 7. The device of embodiment 1, further comprising an indicator rod installed within the upper portion of the outer sleeve, wherein the indicator rod is visible through the first and second indicator windows in the upper portion when the core sleeve is in the initial position. Embodiment 8. The device of embodiment 7, wherein the core sleeve is configured to slide between the indicator rod and the upper portion of the outer sleeve so as to block the first indicator window when the core sleeve is in the first operating position. Embodiment 9. The device of embodiment 8, wherein the core sleeve blocks the first and second indicator windows when the core sleeve is in the second actuated position. Embodiment 10. A training device for simulating intranasal drug delivery, comprising: an outer sleeve having an upper portion and a lower portion; a locking sleeve coupled to the outer sleeve and extending partially through the outer sleeve; a core sleeve coupled to the locking sleeve and configured to slide axially within the outer sleeve and the locking sleeve, the core sleeve having first and second sets of locking features; a plunger operably coupled to the core sleeve, the plunger configured to selectively translate the core sleeve from an initial position to a first actuated position indicating the release of a first simulated dose of the drug, and the plunger configured to translate the core sleeve from the first actuated position to a second actuated position indicating the release of a second simulated dose of the drug; A method wherein the device does not contain a drug. Embodiment 11. The device described in embodiment 10, further comprising an indicator rod installed within the upper portion of the outer sleeve, wherein the indicator rod is visible through the first and second indicator windows in the upper portion when the core sleeve is in the initial position. Embodiment 12. The device of embodiment 11, wherein the core sleeve is configured to slide between the indicator rod and the upper portion of the outer sleeve to block the first indicator window when the core sleeve is in the first actuated position, thereby indicating the release of a first simulated dose of the drug. Embodiment 13. The device of embodiment 12, wherein the core sleeve blocks the first and second indicator windows when the core sleeve is in the second actuated position, thereby indicating the release of a second simulated dose of the drug. Embodiment 14. The device of embodiment 10, further comprising a protective sanitary cap selectively mateable with the outer sleeve and removable from the device. Embodiment 15. The device described in embodiment 10, wherein the first set of locking features each include first and second flanges extending from the outer surface of the core sleeve and a first locking groove defined therebetween, the first locking groove being configured to retain the core sleeve in the first actuated position. Embodiment 16. The device of embodiment 15, wherein the second set of locking features each include third and fourth flanges extending from the outer surface of the core sleeve and a second locking groove defined therebetween, the second locking groove configured to retain the core sleeve in the second actuated position. Embodiment 17. A device as described in embodiment 16, wherein the locking sleeve has at least two snap arms, each having a protrusion extending from its inner surface toward the core sleeve, each protrusion configured to engage with a first locking groove when the core sleeve is in a first operating position, and configured to engage with a second locking groove when the core sleeve is in a second operating position. Embodiment 18. A device as described in embodiment 10, wherein the plunger returns to a starting position after application of the first actuation force and after application of the second actuation force. Embodiment 19. A training device for simulating intranasal drug delivery, comprising: an outer sleeve having an upper portion and a lower portion; a locking sleeve coupled to the outer sleeve and extending partially through the outer sleeve; a core sleeve coupled to the locking sleeve and configured to slide axially within the outer sleeve and the locking sleeve; a plunger operably coupled to the core sleeve, the plunger operably coupled to the core sleeve and configured to translate axially relative to the outer sleeve to selectively slide the core sleeve in the first axial direction from a start position to a first axial position and from the first axial position to a second axial position, the plunger further configured to rotate relative to the outer sleeve between the initial position and an actuated radial position; When the core sleeve is in the second axial position, rotation of the plunger from the initial position to the actuated radial position resets the core sleeve to the starting position such that the core sleeve can be translated axially back to the first and second axial positions, the device. Embodiment 20. The device of embodiment 19, further comprising a protective sanitary cap selectively mateable with and removable from the device. Embodiment 21. A device as described in embodiment 19, wherein the core sleeve is configured to be repeatedly reset. Embodiment 22. The device of embodiment 19, further comprising a first biasing element, biasing the plunger to an initial position until a rotational force is applied to the plunger that overcomes the rotational biasing force of the first biasing element, thereby rotating the plunger in a first rotational direction. Embodiment 23. A device as described in embodiment 22, wherein the release of the rotational force enables the first biasing element to rotate the plunger in a second, opposite rotational direction, allowing the plunger to return to its initial position. Embodiment 24. The device of embodiment 22, further comprising a second biasing element, which biases the core sleeve toward the starting position until an axial force is applied to the core sleeve that overcomes the axial biasing force of the second biasing element, thereby translating the core sleeve in the first axial direction. Embodiment 25. A device as described in embodiment 22, wherein when the core sleeve is in the second axial position, rotation of the plunger in a first rotational direction rotates the core sleeve and disengages it from the locking sleeve. Embodiment 26. A device as described in embodiment 25, wherein a second biasing element urges the core sleeve in a second, opposite axial direction from the second axial position toward the start position when the core sleeve is disengaged from the locking sleeve. Embodiment 27. The device of embodiment 26, wherein release of the rotational force enables the first biasing element to rotate the plunger in a second, opposite rotational direction until the plunger reaches the initial position, and rotation of the plunger in the second rotational direction rotates the core sleeve back to the starting position. Embodiment 28. A method for simulating intranasal drug delivery, comprising: depressing a plunger operably coupled to a core sleeve of the training device, axially translating the core sleeve in a first axial direction from a start position to a first actuation position, the first actuation position being associated with completion of release of a first simulated dose of the drug; depressing the plunger to axially translate the core sleeve in a first axial direction from a first actuation position to a second actuation position, the second actuation position being associated with completion of release of a second simulated dose of the drug; rotating the plunger to reset the core sleeve to a starting position, thereby allowing the core sleeve to translate axially back to the first and second operating positions; A method wherein the device does not contain a drug. Embodiment 29. The method of embodiment 28, further comprising inserting a portion of the device into the first nostril when the core sleeve is in the starting position and prior to depressing the plunger. Embodiment 30. The method of embodiment 29, further comprising removing the device from the first nostril and inserting a portion of the device into the second nostril when the core sleeve is in the first actuated position and before depressing the plunger. Embodiment 31. The rotation of the plunger applying a rotational force to the plunger, the rotational force rotating the plunger in a first rotational direction, thereby moving the plunger from an initial radial position to an actuation radial position; 29. The method of embodiment 28, comprising releasing a rotational force, the rotational force allowing the plunger to rotate in a second, opposite radial direction and return to the initial radial position. Embodiment 32. The method of embodiment 29, wherein, prior to depression of the plunger, an indicator rod installed within the outer sleeve of the training device is visible through the first and second indicator windows of the outer sleeve. Embodiment 33. The method of embodiment 32, wherein depressing the plunger to axially translate the core sleeve to a first actuated position translates the core sleeve distally between the indicator rod and the outer sleeve, thereby blocking the indicator rod from being visible through the first indicator window to indicate completion of release of the first simulated dose of drug. Embodiment 34. The method of embodiment 33, wherein depressing the plunger to axially translate the core sleeve to the second actuated position further translates the core sleeve distally between the indicator rod and the outer sleeve, thereby blocking the indicator rod from being visible through the first and second indicator windows to indicate completion of release of the second simulated dose of drug. Embodiment 35. The method of embodiment 34, wherein rotating the plunger translates the core sleeve back proximally between the indicator rod and the outer sleeve, thereby unblocking the first and second indicator windows so that the indicator rod is visible therethrough to indicate that the core sleeve is reset. It is further noted that the present invention may include the following aspects. [Aspect 1] 1. A training device for simulating intranasal drug delivery, comprising: an outer sleeve having an upper portion and a lower portion; a locking sleeve coupled to the outer sleeve and extending partially through the outer sleeve; a core sleeve coupled to the locking sleeve and configured to slide axially within the outer sleeve and the locking sleeve, the core sleeve having first and second sets of locking features; a plunger operably coupled to the core sleeve, the plunger configured to selectively translate the core sleeve from an initial position to a first actuation position in response to application of a first actuation force exceeding a first force threshold, and the plunger configured to translate the core sleeve from the first actuation position to a second actuation position in response to application of a second actuation force exceeding a second force threshold; the first force threshold corresponds to a first nebulization threshold for releasing a first simulated dose of a drug, and the second force threshold corresponds to a second nebulization threshold for releasing a second simulated dose of the drug; The device does not contain the drug. [Aspect 2] 1. A training device for simulating intranasal drug delivery, comprising: an outer sleeve having an upper portion and a lower portion; a locking sleeve coupled to the outer sleeve and extending partially through the outer sleeve; a core sleeve coupled to the locking sleeve and configured to slide axially within the outer sleeve and the locking sleeve, the core sleeve having first and second sets of locking features; a plunger operably coupled to the core sleeve, the plunger configured to selectively translate the core sleeve from an initial position to a first actuated position indicating the emission of a first simulated dose of a drug, and the plunger configured to translate the core sleeve from the first actuated position to a second actuated position indicating the emission of a second simulated dose of the drug; The device is drug-free. [Aspect 3] A device as described in aspect 1 or 2, further comprising an indicator rod installed within the upper portion of the outer sleeve, the indicator rod being visible through first and second indicator windows in the upper portion when the core sleeve is in the initial position. [Aspect 4] A device as described in aspect 3, wherein the core sleeve is an indicator rod and the upper portion of the outer sleeve blocks the first indicator window when the core sleeve is in the first actuated position, thereby indicating the release of the first simulated dose of the drug. [Aspect 5] A device as described in aspect 4, wherein the core sleeve blocks the first and second indicator windows when the core sleeve is in the second actuated position, thereby indicating the release of the second simulated dose of the drug. [Aspect 6] Aspect 6. The device of any one of aspects 1-5, wherein the first set of locking features each include first and second flanges extending from an outer surface of the core sleeve and a first locking groove defined therebetween, the first locking groove configured to retain the core sleeve in the first actuated position. [Aspect 7] Aspect 7. The device of any one of aspects 1-6, wherein the second set of locking features each include third and fourth flanges extending from an outer surface of the core sleeve and a second locking groove defined therebetween, the second locking groove configured to retain the core sleeve in the second actuated position. [Aspect 8] Aspects 1-7. The device of any one of aspects 1-7, wherein the locking sleeve includes at least two snap arms, each having a protrusion extending from its inner surface toward the core sleeve, each protrusion configured to engage with the first locking groove when the core sleeve is in the first operating position and configured to engage with the second locking groove when the core sleeve is in the second operating position. [Aspect 9] Aspect 9. The device of any one of aspects 1-8, wherein the plunger returns to a starting position after the application of the first actuation force and after the application of the second actuation force. [Aspect 10] 1. A training device for simulating intranasal drug delivery, comprising: an outer sleeve having an upper portion and a lower portion; a locking sleeve coupled to the outer sleeve and extending partially through the outer sleeve; a core sleeve coupled to the locking sleeve and configured to slide axially within the outer sleeve and the locking sleeve; a plunger operably coupled to the core sleeve, the plunger configured to translate axially relative to the outer sleeve to selectively slide the core sleeve from a start position to a first axial position and from the first axial position in a first axial direction, the plunger further configured to rotate relative to the outer sleeve between an initial position and an actuated radial position; A training device, wherein when the core sleeve is in the second axial position, rotation of the plunger from the initial position to the actuated radial position resets the core sleeve to the start position such that the core sleeve can be translated axially back to the first and second axial positions. [Aspect 11] A device as described in embodiment 10, further comprising a protective sanitary cap selectively mateable with and removable from the device, preferably removable from the outer sleeve. [Aspect 12] 12. The device of aspect 10 or 11, wherein the core sleeve is configured to be repeatedly reset. [Aspect 13] A device as described in Aspect 10, or Aspect 11 or 12 dependent on Aspect 10, further comprising a first biasing element that biases the plunger to the initial position until a rotational force is applied to the plunger that overcomes the rotational biasing force of the first biasing element, thereby rotating the plunger in a first rotational direction. [Aspect 14] A device as described in aspect 13, wherein the release of the rotational force enables the first biasing element to rotate the plunger in a second, opposite rotational direction, allowing the plunger to return to the initial position. [Aspect 15] A device as described in aspect 13 or aspect 14, further comprising a second biasing element that biases the core sleeve toward the starting position until an axial force is applied to the core sleeve that overcomes the axial biasing force of the second biasing element, thereby translating the core sleeve in the first axial direction. [Aspect 16] A device as described in any one of aspects 13 to 15, wherein when the core sleeve is in the second axial position, rotation of the plunger in the first rotational direction rotates the core sleeve and disengages it from the locking sleeve. [Aspect 17] A device as described in aspect 15 or aspect 16, wherein when the core sleeve is disengaged from the locking sleeve, the second biasing element urges the core sleeve in a second, opposite axial direction from the second axial position toward the start position. [Aspect 18] A device described in any one of aspects 13 to 17, wherein release of the rotational force enables the first biasing element to rotate the plunger in a second, opposite rotational direction until the plunger reaches the initial position, and rotation of the plunger in the second rotational direction rotates the core sleeve back to the starting position. [Aspect 19] 1. A method for simulating intranasal drug delivery, comprising: depressing a plunger operably coupled to a core sleeve of an exercise device, axially translating the core sleeve in a first axial direction from a start position to a first actuation position, the first actuation position being associated with completion of release of a first simulated dose of a drug; depressing the plunger to axially translate the core sleeve in the first axial direction from the first actuation position to a second actuation position, the second actuation position being associated with completion of release of a second simulated dose of the drug; rotating the plunger to reset the core sleeve to the starting position, thereby allowing the core sleeve to translate axially back to the first and second operating positions; The method wherein the device does not contain a drug. [Aspect 20] Aspect 20. The method of aspect 19, further comprising inserting a portion of the device into a first nostril when the core sleeve is in the start position and prior to depressing the plunger. [Aspect 21] A method as described in aspect 20, further comprising removing the device from the first nostril and inserting the portion of the device into the second nostril when the core sleeve is in the first operating position before depressing the plunger. [Aspect 22] The rotation of the plunger applying a rotational force to the plunger, the rotational force rotating the plunger in a first rotational direction, thereby moving the plunger from an initial radial position to an actuation radial position; 20. The method of claim 19, comprising: releasing the rotational force, the releasing the rotational force allowing the plunger to rotate in a second, opposite radial direction and return to the initial radial position. [Aspect 23] Aspect 20. The method of aspect 19, wherein, prior to depression of the plunger, an indicator rod installed within the outer sleeve of the training device is visible through first and second indicator windows in the outer sleeve. [Aspect 24] 24. The method of claim 23, wherein depressing the plunger to axially translate the core sleeve to the first actuated position translates the core sleeve distally between the indicator rod and the outer sleeve, thereby blocking the indicator rod from being visible through the first indicator window to indicate completion of release of the first simulated dose of the drug. [Aspect 25] The method of claim 24, wherein depressing the plunger to axially translate the core sleeve to the second actuated position further translates the core sleeve in the distal direction between the indicator rod and the outer sleeve, thereby blocking the indicator rod from being visible through the first and second indicator windows to indicate completion of release of the second simulated dose of the drug. [Aspect 26] Aspect 26. The method of aspect 25, wherein rotating the plunger translates the core sleeve back proximally between the indicator rod and the outer sleeve, thereby unblocking the first and second indicator windows so that the indicator rod is visible therethrough to indicate that the core sleeve is reset.

Claims

1. 1. A training device for simulating intranasal drug delivery, comprising: an outer sleeve having an upper portion and a lower portion; a locking sleeve coupled to the outer sleeve and extending partially through the outer sleeve; a core sleeve coupled to the locking sleeve and configured to slide axially within the outer sleeve and the locking sleeve, the core sleeve having first and second sets of locking features; a plunger operably coupled to the core sleeve, the plunger configured to selectively translate the core sleeve from an initial position to a first actuation position in response to application of a first actuation force exceeding a first force threshold, and the plunger configured to translate the core sleeve from the first actuation position to a second actuation position in response to application of a second actuation force exceeding a second force threshold; the first force threshold corresponds to a first nebulization threshold for releasing a first simulated dose of a drug, and the second force threshold corresponds to a second nebulization threshold for releasing a second simulated dose of the drug; the device does not contain the drug; the first set of locking features engage the locking sleeve to retain the core sleeve in the initial position; the second set of locking features engages the locking sleeve to retain the core sleeve in the first actuated position; device.

2. 1. A training device for simulating intranasal drug delivery, comprising: an outer sleeve having an upper portion and a lower portion; a locking sleeve coupled to the outer sleeve and extending partially through the outer sleeve; a core sleeve coupled to the locking sleeve and configured to slide axially within the outer sleeve and the locking sleeve, the core sleeve having first and second sets of locking features; a plunger operably coupled to the core sleeve, the plunger configured to selectively translate the core sleeve from an initial position to a first actuated position indicating the emission of a first simulated dose of a drug, and the plunger configured to translate the core sleeve from the first actuated position to a second actuated position indicating the emission of a second simulated dose of the drug; the device is drug-free; the first set of locking features engage the locking sleeve to retain the core sleeve in the initial position; the second set of locking features engages the locking sleeve to retain the core sleeve in the first actuated position; device.

3. 3. The device of claim 1, further comprising an indicator rod installed within the upper portion of the outer sleeve, the indicator rod being visible through first and second indicator windows in the upper portion when the core sleeve is in the initial position.

4. 4. The device of claim 3, wherein the core sleeve is configured to slide between the indicator rod and the upper portion of the outer sleeve such that the upper portion of the outer sleeve blocks the first indicator window when the core sleeve is in the first actuated position, thereby indicating the release of the first simulated dose of the drug.

5. 5. The device of claim 4, wherein the core sleeve blocks the first and second indicator windows when the core sleeve is in the second actuated position, thereby indicating release of the second simulated dose of the drug.

6. 3. The device of claim 1, wherein the first set of locking features each include first and second flanges extending from an outer surface of the core sleeve and a first locking groove defined therebetween, the first locking groove configured to retain the core sleeve in the first actuated position.

7. 3. The device of claim 1, wherein the second set of locking features each include third and fourth flanges extending from an outer surface of the core sleeve and a second locking groove defined therebetween, the second locking groove configured to retain the core sleeve in the second actuated position.

8. The second set of locking features each include third and fourth flanges extending from an outer surface of the core sleeve and a second locking groove defined therebetween, the second locking grooves configured to hold the core sleeve in the second operating position; 7. The device of claim 6, wherein the locking sleeve comprises at least two snap arms, each having a protrusion extending from its inner surface toward the core sleeve, each protrusion configured to engage with the first locking groove when the core sleeve is in the first operating position and configured to engage with the second locking groove when the core sleeve is in the second operating position.

9. The device of claim 1 , wherein the plunger returns to a starting position after the application of the first actuation force and after the application of the second actuation force.

10. 1. A training device for simulating intranasal drug delivery, comprising: an outer sleeve having an upper portion and a lower portion; a locking sleeve coupled to the outer sleeve and extending partially through the outer sleeve; a core sleeve coupled to the locking sleeve and configured to slide axially within the outer sleeve and the locking sleeve; a plunger operably coupled to the core sleeve, the plunger configured to translate in a first axial direction relative to the outer sleeve to selectively slide the core sleeve from a start position to a first axial position and from the first axial position to a second axial position, the plunger further configured to rotate relative to the outer sleeve between an initial position and an actuated radial position; rotation of the plunger from the initial position to the actuation radial position when the core sleeve is in the second axial position resets the core sleeve to the start position such that the core sleeve can be axially translated back to the first and second axial positions; the locking sleeve and the core sleeve engage with each other to hold the core sleeve in the start position, the first axial position, or the second axial position; Training device.

11. 11. The device of claim 10, further comprising a protective sanitary cap selectively mateable with and removable from the device.

12. The device of claim 10 , wherein the core sleeve is configured to be repeatedly reset.

13. 11. The device of claim 10, further comprising a first biasing element that biases the plunger toward the initial position until a rotational force is applied to the plunger that overcomes the rotational biasing force of the first biasing element, thereby rotating the plunger in a first rotational direction.

14. 14. The device of claim 13, wherein release of the rotational force enables the first biasing element to rotate the plunger in a second, opposite rotational direction, allowing the plunger to return to the initial position.

15. 14. The device of claim 13, further comprising a second biasing element that biases the core sleeve toward the starting position until an axial force is applied to the core sleeve that overcomes the axial biasing force of the second biasing element, thereby translating the core sleeve in the first axial direction.

16. 14. The device of claim 13, wherein when the core sleeve is in the second axial position, rotation of the plunger in the first rotational direction rotates the core sleeve and disengages it from the locking sleeve.

17. 16. The device of claim 15, wherein the second biasing element urges the core sleeve in a second, opposite axial direction from the second axial position toward the start position when the core sleeve is disengaged from the locking sleeve.

18. 14. The device of claim 13, wherein release of the rotational force enables the first biasing element to rotate the plunger in a second, opposite rotational direction until the plunger reaches the initial position, and rotation of the plunger in the second, opposite rotational direction rotates the core sleeve back to the starting position.

19. 1. A method for simulating intranasal drug delivery, comprising: depressing a plunger operably coupled to a core sleeve of an exercise device, axially translating the core sleeve in a first axial direction from a start position to a first actuation position, the first actuation position being associated with completion of release of a first simulated dose of a drug; depressing the plunger to axially translate the core sleeve in the first axial direction from the first actuation position to a second actuation position, the second actuation position being associated with completion of release of a second simulated dose of the drug; rotating the plunger to reset the core sleeve to the start position, wherein rotating the plunger resets the core sleeve to the start position such that the core sleeve, having returned to the start position, can be translated in the first axial direction to the first and second operating positions; The method wherein the device does not contain a drug.

20. 20. The method of claim 19, further comprising inserting a portion of the device into a first nostril when the core sleeve is in the start position and prior to depressing the plunger.

21. 21. The method of claim 20, further comprising removing the device from the first nostril and inserting the portion of the device into a second nostril when the core sleeve is in the first actuated position and prior to depressing the plunger.

22. The rotation of the plunger applying a rotational force to the plunger, the rotational force rotating the plunger in a first rotational direction, thereby moving the plunger from an initial radial position to an actuation radial position; 20. The method of claim 19, comprising: releasing the rotational force, the releasing the rotational force allowing the plunger to rotate in a second, opposite radial direction and return to the initial radial position.

23. 20. The method of claim 19, wherein an indicator rod located within an outer sleeve of the training device is visible through first and second indicator windows in the outer sleeve prior to depression of the plunger.

24. 24. The method of claim 23, wherein depressing the plunger to axially translate the core sleeve to the first actuated position translates the core sleeve distally between the indicator rod and the outer sleeve, thereby blocking the indicator rod from being visible through the first indicator window to indicate completion of release of the first simulated dose of the drug.

25. 25. The method of claim 24, wherein depressing the plunger to axially translate the core sleeve to the first actuated position further translates the core sleeve in the distal direction between the indicator rod and the outer sleeve, thereby blocking the indicator rod from being visible through the first and second indicator windows to indicate completion of release of the second simulated dose of the drug.

26. 26. The method of claim 25, wherein rotating the plunger translates the core sleeve back proximally between the indicator rod and the outer sleeve, thereby unblocking the first and second indicator windows so that the indicator rod is visible therethrough to indicate that the core sleeve is reset.

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