Patent Description:
There are many different ways in which a drug can be administered to a user. Depending on the drug, intranasal drug delivery can be one of the most effective ways to achieve desired clinical benefits in a timely manner and in a manner that is convenient and comfortable for a patient.

Intranasal drug administration is a non-invasive route for drug delivery. Since the nasal mucosa offers numerous benefits as a target tissue for drug delivery, a wide variety of drugs may be administered by intranasal systemic action. Moreover, intranasal drug delivery can avoid the risks and discomfort associated with other routes of drug delivery (e.g., intravenous drug delivery), and can allow for easy self-administration.

Generally, to maximize the efficacy of the drug through intranasal administration, the majority volume of the aerosolized dose of the drug needs to reach the correct region of the nasal cavity. As such, additional measures may need to be taken for effective intranasal drug delivery. For example, the user may need to have a clear nostril; tilt their head back at approximately <NUM>°; close the opposite nostril, and then sniff gently while the dose of drug is administered. In order to coordinate these measures, and given that nasal administration is intimate, self-administration by the user may be desired. Further, due to the nasal cycle (alternating physiological partial congestion of the nasal turbinate to facilitate nasal function) or pathological congestion, one nostril is likely to provide a more effective drug delivery route than the other nostril at any given time. As such, it is desired that an equal dose of the drug be delivered to each nostril of the user to inhibit under-dosing of the drug.

Dual-dose intranasal drug delivery devices are available that are designed for self-administration of two distinct aerosolized sprays, one for each nostril, that together constitute one dose of drug. These devices require a series of operational steps that the user needs to properly carry out to effect optimal drug delivery through self-administration. While users are typically provided with user manuals, commonly referred to as Instructions For Use (IFU), these manuals are limited in that they only graphically represent and textually describe the operational steps for using the device. As a result, prior to use, the user cannot have a tactile experience in using the device, which can lead to user misuse of the device, and thus ultimately inhibit effective drug delivery.

Accordingly, there remains a need for training devices that simulate the use of an intranasal drug delivery device without having to deliver any drug to the user.

Various training devices and methods are disclosed for simulating intranasal drug delivery. The present invention relates to a training device for simulating intranasal drug delivery as defined in independent claim <NUM> and a method for simulating intranasal drug delivery as defined in independent claim <NUM>.

In one exemplary embodiment, a training device is provided and includes an outer sleeve having upper and lower portions, a locking sleeve coupled to the outer sleeve and partially extending therethrough, a core sleeve coupled to the locking sleeve and configured to axially slide within the outer and locking sleeves, the core sleeve having first and second sets of locking features, and a plunger operatively coupled to the core sleeve. The plunger is configured to selectively translate the core sleeve from an initial position to a first actuated position in response to the application of a first actuation force that exceeds a first force threshold, and configured to translate the core sleeve from the first actuated position to a second actuated position in response to the application of a second actuation force that exceeds a second force threshold, in which the first force threshold corresponds to a first spray threshold for releasing a first simulated dose of a drug and the second force threshold corresponds to a second spray threshold for releasing a second simulated dose of the drug, and the device does not contain the drug.

In some embodiments, the training device can include a protective hygiene cap that can be selectively mateable with and removable from the device.

The first and second sets of locking features can have a variety of configurations. For example, in some embodiments, the first sets of locking features can each include first and second flanges extending from an outer surface of the core sleeve and a first locking groove defined therebetween, in which the first locking groove can be configured to retain the core sleeve in the first actuated position. The second sets of locking features can each include third and fourth flanges extending from an outer surface of the core sleeve and a second locking groove defined therebetween, in which the second locking groove can be configured to retain the core sleeve in the second actuated position. In certain embodiments, the locking sleeve can include at least two snap arms, in which each snap arm has a protrusion extending from an inner surface thereof and toward the core sleeve, and each protrusion can be configured to engage the first locking groove when the core sleeve is in the first actuated position and configured to engage the second locking groove when the core sleeve is the second actuated position.

In some embodiments, the plunger can return to a start position after the application of the first actuation force and after the application of the second actuation force.

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 viewable through first and second indicator windows of the upper portion when the core sleeve is in the initial position. In such embodiments, the core sleeve can be configured to slide between 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.

In another exemplary embodiment, a training device is provided and includes an outer sleeve having upper and lower portions, a locking sleeve coupled to the outer sleeve and partially extending therethrough, a core sleeve coupled to the locking sleeve and configured to axially slide within the outer and locking sleeves, the core sleeve having first and second sets of locking features, and a plunger operatively coupled to the core sleeve. The plunger is configured to selectively translate the core sleeve from an initial position to a first actuated position that indicates the release of a first simulated dose of a drug, and the plunger is configured to translate the core sleeve from the first actuated position to a second actuated position that indicates the release of a second simulated dose of the drug, in which the device does not contain a drug.

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 viewable through first and second indicator windows of 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 to thereby indicate the release of the 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 to thereby indicate the release of the second simulated dose of the drug.

In some embodiments, the training device can include a protective hygiene cap that can be selectively mateable with and removable from the outer sleeve.

In another exemplary embodiment, a training device is provided and includes an outer sleeve having upper and lower portions, a locking sleeve coupled to the outer sleeve and partially extending therethrough, a core sleeve coupled to the locking sleeve and configured to axially slide within the outer and locking sleeves, and a plunger operatively coupled to the core sleeve. The plunger is configured to axially translate 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, and the plunger is configured to rotate relative to the outer sleeve between an initial position and an actuated radial position, in which 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 axially translate back to the first and second axial positions.

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

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

In some embodiments, the training device can include a first biasing element that can bias the plunger to the initial position until a rotational force is applied to the plunger that overcomes a rotational biasing force of the first biasing element and thereby rotates the plunger in a first rotational direction. The release of the rotational force can allow the first biasing element to rotate the plunger in a second, opposite rotational direction to allow the plunger to return to the initial position. In certain embodiments, the training device can include a second biasing element that can bias the core sleeve to the start position until an axial force is applied to the core sleeve that overcomes an axial biasing force of the second biasing element and thereby translates the core sleeve in the first axial direction. In yet another embodiment, when the core sleeve is in the second axial position, rotation of the plunger in the first rotational direction can cause the core sleeve to rotate and disengage from the locking sleeve. Further, when the core sleeve is disengaged from the locking sleeve, the second biasing element can force the core sleeve in a second, opposite axial direction from the second axial position toward the start position. Further, a release of the rotational force can allow 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 start position.

Methods for simulating intranasal drug delivery are also provided. In one exemplary embodiment, the method can include depressing a plunger operatively coupled to a core sleeve of a training device to axially translate the core sleeve in a first axial direction from a start position to a first actuated position, the first actuated position being associated with the completion of the 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 actuated position to a second actuated position, the second actuated position being associated with the completion of the release of a second simulated dose of the drug, and rotating the plunger to reset the core sleeve to the start position to thereby allow the core sleeve to axially translate back to the first and second actuated positions, in which the device does not contain a drug.

In some embodiments, the method can include, prior to depression of the plunger when the core sleeve is in the start position, inserting a portion of the device into a first nostril. In such embodiments, the method can include, prior to depression of the plunger when the core sleeve is in the first actuated position, removing the device from the first nostril and inserting the portion of the device into a second nostril.

In some embodiments, rotation of the plunger can include applying a rotational force to the plunger to rotate the plunger in a first rotational direction to thereby move the plunger from an initial radial position to an actuated radial position, and releasing the rotational force to allow the plunger to rotate in a second, opposite radial direction and return to the initial radial position.

In some embodiments, prior to depression of the plunger, an indicator rod disposed within an outer sleeve of the training device can be viewable through first and second indicator windows of the outer sleeve. In such embodiments, depressing the plunger to axially translate the core sleeve to the first actuated position can cause the core sleeve to translate in a distal direction between the indicator rod and the outer sleeve to thereby block the indicator rod from being viewable through the first indicator window to indicate the completion of the release of the first simulated dose of the drug. In such embodiments, depressing the plunger to axially translate the core sleeve to the second actuated position can cause the core sleeve to further translate in the distal direction between the indicator rod and the outer sleeve to thereby block the indicator rod from being viewable through the first and second indicator windows to indicate the completion of the release of the second simulated dose of the drug. In such embodiments, rotating the plunger can cause the core sleeve to translate back in a proximal direction between the indicator rod and the outer sleeve to thereby unblock the first and second indicator windows such that the indicator rod is viewable therethrough to indicate that the core sleeve is reset.

This invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:.

Certain exemplary embodiments will now be described to provide an overall 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 present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

Various training devices and methods are provided for simulating intranasal drug administration without delivering drug to the 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 one user or multiple users. As a result, prior to using the intranasal drug delivery device, a user can use these training devices to learn and familiarize themselves with the operational steps and proper techniques needed to effectively use the intranasal drug delivery device.

The training devices generally include 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 actuated position that is associated with the release of a first simulated dose of a drug and further to a second actuated position that is associated with the release of a second simulated dose of the drug. The release of the first simulated dose and the second simulated dose correspond to the release of the first dose and the second dose of drug, respectively, from an intranasal drug delivery device. As a result, positioning and actuating the training devices provides the user with a similar tactile experience to that of positioning and actuating the intranasal drug delivery device. Further, repeated use of the training devices allows the user to develop a degree of muscle memory, which can be helpful in developing the proper use techniques of the intranasal drug delivery device. Thus, these training devices provide the user with the ability to practice, and consequently familiarize himself/herself with, the operational steps required for proper use of the intranasal drug delivery device to optimize drug delivery and drug efficacy, while also reducing waste and user anxiety.

In general, the training devices described herein are designed to carry out three stages of operation without expelling any drug to the user. The first and second stages of operation 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 form, device positioning, and device actuation that is used to release a drug from a dual-dose intranasal drug delivery device. Further, unlike the dual-dose intranasal drug delivery devices, the training devices are not designed for a one-time use, but rather multiple uses, and therefore includes a third stage of operation to reset the device for subsequent simulated doses, either by the same user or different users. In particular, the training devices include a reset mechanism that can be activated after the completion of the second stage of operation to reset the device. As a result, a user can repeatedly use the training devices to simulate intranasal drug delivery without releasing any drug. Non-limiting exemplary embodiments of other suitable dual-dose intranasal drug delivery devices are described in more detail in <CIT>, <CIT>, and <CIT>.

An exemplary training device can include a variety of features to facilitate simulation of intranasal drug delivery of a drug from a dual-dosed intranasal drug delivery device, as described herein and illustrated in the drawings. However, a person skilled in the art will appreciate that the training devices can include only some of these features and/or can include a variety of other features known in the art. The training devices described herein are merely intended to represent certain exemplary embodiments.

<FIG> illustrate an exemplary embodiment of a training device <NUM> that is configured to simulate intranasal drug delivery. The device <NUM> includes an outer sleeve <NUM>, a depth guide <NUM>, a finger rest <NUM>, a locking sleeve <NUM>, a core sleeve <NUM>, and a plunger <NUM>.

While the outer sleeve <NUM> can have a variety of configurations, the outer sleeve <NUM>, as shown in <FIG>, includes upper and lower segments 114a, 114b. The upper and lower segments 114a, 114b each have a cylindrical structure. As shown, the upper segment 114a culminates in a tip <NUM>. The tip <NUM> is configured to be inserted into a first nostril during the first stage of operation of the device <NUM> and a second nostril during the second stage of operation of the device <NUM>. In other embodiments, the upper and lower segments 114a, 114b can have other suitable structural configurations.

As shown in <FIG>, <FIG> and <FIG>, the upper segment 114a of the outer sleeve <NUM> includes an indicator frame <NUM> that surrounds two indicator windows 118a, 118b. In this illustrated embodiment, the indicator frame <NUM> has an oblong-shaped configuration and the two indicator windows 118a, 118b each have a circular-shaped configuration. In other embodiments, the indicator frame <NUM> and the two indiator windows 118a, 118b can have other suitable shaped configurations. As further shown in <FIG> and <FIG>, an indicator rod <NUM> is disposed within the outer sleeve <NUM> and partially extends through the upper segment 114a such that it overlaps with the two indicator windows 118a, 118b. As explained in more detail below, the indicator rod <NUM> is visible through the two indicator windows 118a, 118b prior to actuation of the device <NUM>. That is, the visibility of the indicator rod <NUM> through both of these indicator windows 118a, 118b indicates to the user that the device <NUM> is in the start position. Further, in some embodiments, the indicator rod <NUM> can have a first color that is different than the color of the upper segment 114a of the outer sleeve <NUM> so as to enhance the visibility of the indicator rod <NUM> through the indicator windows 118a, 118b. For example, prior to any actuation and when the device <NUM> is ready for use, the indicator windows 118a, 118b can show a color such as green. After the first actuation the indicator window 118a can show a different color such as white and after the second actuation the indicator window 118b can likewise show the color white.

As shown in <FIG>, <FIG> and <FIG>, the depth guide <NUM> is conjoined to the finger rest <NUM> via an elongated tubular body <NUM>. The depth guide <NUM> includes a first set of opposing flanges 124a, 124b extending from a first end 122a of the elongated tubular body <NUM>. The first set of opposing flanges 124a, 124b are configured to limit the insertion depth of the upper segment 114a of the outer sleeve <NUM> into a user's nostril. The finger rest <NUM> includes a second set of two opposing flanges 126a, 126b extending from a second, opposing end 122b of the elongated tubular body <NUM>. The finger rest <NUM> acts as a positioning guide for fingers of a user, e.g., the index and middle fingers of a user, such that a user can grasp and hold the device <NUM> while depressing the plunger <NUM> toward the upper segment 114a of the outer sleeve <NUM> using their thumb. The elongated tubular body <NUM> includes an oblong shaped hole <NUM> that corresponds to the indicator frame <NUM> of the upper segment 114a of the outer sleeve <NUM>. As such, when the elongated tubular body <NUM>, and consequently the depth guide <NUM> and finger rest <NUM>, are positioned about a portion of the upper segment 114a of the outer sleeve <NUM>, as shown in <FIG>, the indicator frame <NUM> extends through the oblong-shaped hole <NUM> of the elongated tubular body <NUM> to retain its position.

The locking sleeve <NUM> has an annular collar <NUM> that is coupled between the upper and lower segments 114a, 114b of the outer sleeve <NUM>, thereby forming a shoulder <NUM>. This coupling engagement retains the locking sleeve <NUM> in an immobile position within the outer sleeve <NUM>. The locking sleeve <NUM> also includes snap arms <NUM> extending proximally from the annular collar <NUM> and partially through the lower segment 114b of the outer sleeve <NUM>. While the number of snap arms <NUM> can vary, in this illustrated embodiment, the locking sleeve <NUM> includes three snap arms <NUM> oriented parallel to and arranged equally about the longitudinal axis (LA) of the device <NUM>. Each snap arm <NUM> includes an inward-facing protrusion <NUM>, only one of which is shown, that is configured to engage locking features on the core sleeve <NUM>. As such, the snap arms <NUM> can simultaneously flex outwardly when a conical profile is forced upwardly towards the upper segment 114a of the outer sleeve <NUM> and over inward-facing protrusions <NUM>.

While the protrusions <NUM> can have a variety of configurations, as shown in <FIG> and <FIG>, the protrusions <NUM> each include at least a ramped surface 136a and a planar surface 136b. The planar surface 136b surface extends in a direction that is orthogonal to the longitudinal axis of the device <NUM>. As will be discussed in more detail below, the ramped surface 136a of each protrusion <NUM> is configured to slide over flanges (such as second, third, and fourth flanges <NUM>, <NUM>, and <NUM>) on the core sleeve <NUM> during the first and second stages of operation to allow for axial translation of the core sleeve <NUM> relative to the locking sleeve <NUM> and the planar surface 136b is configured to engage locking grooves (such as first, second, and third locking grooves <NUM>, <NUM>, and <NUM>) on the core sleeve to lock the core sleeve in various positions.

As shown in <FIG> and <FIG>, and in more detail in <FIG>, the core sleeve <NUM> extends from an open end 110a to a closed end 110b. A first biasing element <NUM> is retained within and compressed between the closed end 110b of the core sleeve <NUM> and an end 120a of the indicator rod <NUM>. While the first biasing element <NUM> can have a variety of configurations, in this illustrated embodiment, the first biasing element <NUM> is a helical spring. The core sleeve <NUM> includes first sets of locking features <NUM>. The first sets of locking features <NUM> in combination with the partial compression of the first biasing element <NUM> couples the core sleeve to the locking sleeve <NUM>. Thus, the first biasing element <NUM> is configured to bias the core sleeve <NUM> to its initial position. As used herein, the term "initial position" is used synonymously with the term "start position.

The first sets of locking features <NUM> are positioned proximal to the open end 110a of the core sleeve <NUM>. In this illustrated embodiment, the core sleeve <NUM> includes three first sets of locking features <NUM> that are substantially similar in structural configuration and configured to engage one corresponding protrusion <NUM> of one snap arm <NUM> of the locking sleeve <NUM>. As such, for sake of simplicity, the following discussion is with respect to one of the first sets of locking features <NUM>. A person skilled in the art will understand, however, that the following discussion is also applicable to the remaining first sets of locking features <NUM>. Further, in other embodiments, the core sleeve <NUM> can include less than or greater than three first sets of locking features <NUM>.

While the first set of locking features <NUM> can have a variety of structural configurations, the first set of locking features <NUM> as shown in <FIG>, includes first and second flanges <NUM>, <NUM> extending from the outer surface 111a of the core sleeve <NUM> and a first locking grove <NUM> defined therebetween. As shown, the first and second flanges <NUM>, <NUM> each include at least a ramped surface 142a, 144a and a planar surface 144a, 144b. The planar surface 144a, 144b extends in a direction orthogonal to the longitudinal axis of the device <NUM>. The core sleeve <NUM> is therefore held in its start position by the first set of locking features <NUM> that interact with the protrusion <NUM> of the locking sleeve <NUM>. That is, after assembling the device <NUM>, the protrusion <NUM> of the locking sleeve <NUM> engages with the first locking groove <NUM> defined between the first and second flanges <NUM>, <NUM> and is maintained in that position until a user actuates the device <NUM> during the first stage of operation.

Further, the ramped surface 142a of the second flange <NUM> has a ramp profile that is structurally designed such that during use, a certain amount of force needs to be applied to the core sleeve <NUM> before the ramp profile forces the snap arms <NUM> outwards at which point the core sleeve <NUM> can move freely towards the tip <NUM> of the device <NUM> and into a first actuated position. That is, the axial force (first actuation force) that is applied to the core sleeve <NUM> must exceed a first force threshold to allow the core sleeve <NUM> to be axially translated via the plunger <NUM> to a first actuated position. This first force threshold corresponds to a first spray threshold for releasing a first simulated dose of a drug from an intranasal drug delivery device. In one embodiment, the ramp profile can be engineered to match the first spray threshold of the intranasal drug delivery device ±<NUM>%.

The core sleeve <NUM> can include additional sets of locking features. For example, as shown in <FIG> and <FIG>, the core sleeve <NUM> includes second sets of locking features <NUM>, which, as will be discussed in more detail, maintain the core sleeve <NUM> in a first actuated position. In this illustrated embodiment, the core sleeve <NUM> includes three second sets of locking features <NUM> that are substantially similar in structural configuration and configured to engage one corresponding protrusion <NUM> of one snap arm <NUM> of the locking sleeve <NUM>. As such, for sake of simplicity, the following discussion is with respect to one of the second sets of locking features <NUM>. A person skilled in the art will understand, however, that the following discussion is also applicable to the remaining second sets of locking features <NUM>. Further, in other embodiments, the core sleeve <NUM> can include less than or greater than three second sets of locking features <NUM>.

While the second set of locking features <NUM> can have a variety of structural configurations, the second set of locking features <NUM>, as shown in <FIG>, includes third <NUM> and fourth flanges <NUM> extending from the outer surface 111a of the core sleeve <NUM> and a second locking groove <NUM> defined therebetween. As shown, the third <NUM> and fourth flanges <NUM> each include at least a ramped surface 150a, 152a and a planar surface 150b, 152b. The planar surface 150b, 152b extends in a direction that is orthogonal to the longitudinal axis (LA) of the device <NUM>. The core sleeve <NUM> is therefore held in a first actuated position by the second set of locking features <NUM> that interact with the protrusion <NUM> of the locking sleeve <NUM>. That is, the protrusion <NUM> of the locking sleeve <NUM> engages with the second locking groove <NUM> defined between the third <NUM> and fourth flanges <NUM>, and is maintained in that position until a user actuates the device <NUM> during the second stage of operation.

The ramped surface 150a of the third flange <NUM> has a ramp profile that is smaller than the ramp profile of the ramped surface 144a of the second flange <NUM>. The smaller diameter of this ramp profile ensures that the user does not need to apply an increased force to the core sleeve <NUM> to slide over the ramped surface 150a of the third flange <NUM>. That is, the first actuation force is sufficient to slide the core sleeve <NUM> from its initial position to its first actuated position.

Further, the ramped surface 152a of the fourth flange <NUM> has a ramp profile that is structurally designed such that during use, a certain amount of force needs to be applied to the core sleeve <NUM> before the ramp profile forces the snap arms <NUM> outwardly at which point the core sleeve <NUM> can move freely and further towards the tip <NUM> of the device <NUM> and into a second actuated position. That is, the axial force (second actuation force) applied to the core sleeve <NUM> must exceed a second force threshold to allow the core sleeve <NUM> to be axially translated via the plunger <NUM> to a second actuated position. This second force threshold corresponds to a second spray threshold for releasing a first simulated dose of a drug from an intranasal drug delivery device. In some embodiments, the second force threshold can be the same as the first force threshold, whereas in other embodiments, the second force threshold can be either greater than or less than 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 engineered to match the second spray threshold of the intranasal drug delivery device ±<NUM>%.

The core sleeve <NUM> can also include third sets of locking features <NUM>, which, as will be discussed in more detail, maintain the core sleeve <NUM> in a second actuated position. In this illustrated embodiment, the core sleeve <NUM> includes three third sets of locking features <NUM> that are substantially similar in structural configuration and configured to engage one corresponding protrusion of one snap arm <NUM> of the locking sleeve <NUM>. As such, for sake of simplicity, the following discussion is with respect to one of the third sets of locking features <NUM>. A person skilled in the art will understand, however, that the following discussion is also applicable to the remaining third sets of locking features <NUM>. Further, in other embodiments, the core sleeve <NUM> can include less than or greater than three third sets of locking features <NUM>.

While the third set of locking features <NUM> can have a variety of structural configurations, as shown in <FIG>, the third set of locking features <NUM> includes the fourth flange <NUM> and a fifth flange <NUM> extending from the outer surface 111a of the core sleeve <NUM> and a third locking grove <NUM> defined therebetween. As shown, the fifth flange <NUM> also includes at least a ramped surface 158a and a planar surface 158b. The planar surface 158b extends in a direction that is orthogonal to the longitudinal axis (LA) of the device <NUM>. The core sleeve <NUM> is therefore held in a second actuated position by the third set of locking features <NUM> that interact with the protrusion <NUM> of the locking sleeve <NUM>. That is, the protrusion <NUM> of the locking sleeve <NUM> engages with the third locking groove <NUM> defined between the fourth and fifth flanges <NUM>, <NUM>, and is maintained in that position until a user resets the device <NUM> during the third stage of operation.

Further, as shown in <FIG>, the plunger <NUM> is operatively coupled to the core sleeve <NUM> and configured to axially translate relative to the outer sleeve <NUM> to selectively slide the core sleeve <NUM> from its start 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 <NUM>, respectively. The plunger <NUM> is also configured to rotate relative to the outer sleeve <NUM> between an initial radial position and an actuated radial position to reset the device <NUM> after completion of the second stage of operation. While the plunger <NUM> can have a variety of configurations, the plunger <NUM>, in this illustrated embodiment has an elongated tubular configuration extending from a first end 162a to a second end 162b. The plunger <NUM> also includes three equally spaced cantilever arms <NUM>, as shown in <FIG>. The cantilever arms <NUM>, two of which are obstructed in <FIG>, are arranged radially from the first end 162a of the plunger <NUM> and extending towards the core sleeve <NUM>. The plunger <NUM> can also include gripping features <NUM> to aid in rotation of the plunger <NUM>, as shown in <FIG>, <FIG>, and <FIG>.

A second biasing element <NUM> sits partially within the lower segment 114b of the outer sleeve <NUM>, surrounding the locking and core sleeves <NUM>, <NUM>. While the second biasing element <NUM> can have a variety of configurations, in this illustrated embodiment, the second biasing element <NUM> is a helical spring. The ends 166a, 166b of this second biasing element <NUM> are each configured as a short tail that is parallel to the longitudinal axis (LA) of the device <NUM>. As shown, the first end 166a interacts with the shoulder <NUM> formed by the annular collar <NUM> of the locking sleeve <NUM> and the upper and lower segments 114a, 114b of the outer sleeve <NUM> such that the second biasing element <NUM> cannot freely rotate about the longitudinal axis of the device <NUM>.

As shown in <FIG>, the plunger <NUM> is fitted over and partially compresses the second biasing element <NUM>. While not shown, during assembly, the second end 166b of the second biasing element <NUM> engages with a rib on the inner surface 113a of the plunger <NUM>. As a result, when the plunger <NUM> is fitted over the second biasing element <NUM>, it is rotated clockwise about the longitudinal axis (LA) of the device <NUM>, thereby applying torsion to the second biasing element <NUM>. As such, the second biasing element <NUM> biases the plunger <NUM> to an initial radial position, as shown in <FIG>.

Further, the plunger <NUM> is partially disposed within the lower segment 114b of the outer sleeve <NUM> and coupled thereto by a locking ring <NUM>. The plunger <NUM>, as shown in more detail in <FIG>, includes three equally-spaced lugs <NUM> on outer surface 113b of the plunger <NUM> and positioned at the second end 112b of the plunger <NUM>. The three lugs <NUM> each have a L-shaped configuration (see <FIG>). As further shown in <FIG>, the plunger <NUM> also includes three equally spaced axially-aligned rib features <NUM> on the inner surface 113a of the plunger <NUM>. These rib features <NUM> are configured to engage corresponding rib features <NUM> on the core sleeve <NUM> such that the plunger <NUM> and the core sleeve <NUM> rotate together during a portion of the third stage of operation. As discussed below, this engagement allows the core sleeve <NUM> to disengage from, and rotate relative to, the locking sleeve <NUM> during a portion of the third stage of operation.

The plunger <NUM> is partially disposed within the lower segment 114b of the outer sleeve <NUM> so that the three lugs <NUM> are positioned within corresponding, axially-aligned channels <NUM>, two of which are shown in <FIG>, on the inner surface of the lower segment 114b of the outer sleeve <NUM>. As a result, during use, the plunger <NUM> can be depressed axially so that the three lugs <NUM> run along the channels <NUM> as the second biasing element <NUM> is compressed. Further, when the plunger <NUM> is in its initial radial position, it can be rotated in a first rotational direction to a limited degree, thereby applying further torque to the second biasing element <NUM>. The second biasing element <NUM> therefore serves a dual purpose of returning the plunger <NUM> 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 the device operation.

As mentioned above, the training device <NUM> has three stages of operation, in which the first stage of operation is illustrated in <FIG>, the second stage of operation is illustrated in <FIG>, and the third stage of operation is illustrated in <FIG>. In general, the first stage of operation involves axial translation of the core sleeve <NUM> to mimic a first spray of a drug from an intranasal drug delivery device, the second stage of operation involves further axial translation of the core sleeve <NUM> to mimic a second spray of the drug from the intranasal drug delivery device, and the third stage of operation involves rotation of the plunger <NUM> to axially reset the device <NUM>, and thus the core sleeve <NUM>, to its starting position for reuse. Each stage of operation is described in more detail below.

While not shown, prior to the first stage of operation, a user inserts the tip <NUM> of the outer sleeve <NUM> into their first nostril until the depth guide <NUM> contacts the skin between their first and second nostrils, such that the longitudinal axis (LA) of the device <NUM> is aligned with the axis of the first nostril. Further, prior to insertion, in some embodiments, the user can tilt their head about <NUM> degrees relative to their neck.

During the first stage of operation, the user applies a first actuation force to the first end 112a of the plunger <NUM> in an axial direction (A<NUM>) toward the upper segment 114a of the outer sleeve <NUM>. The user can apply this force with their thumb in opposition to their fingers on the finger rest <NUM>. This applied force first causes the cantilever arms <NUM> of the plunger <NUM> to push against the planar surface 158b of the fifth flange <NUM> on the core sleeve <NUM>. Once the applied force exceeds a first threshold force, the plunger <NUM> axially translates the core sleeve <NUM> from its start position (<FIG>), in which the protrusions <NUM> of the locking sleeve <NUM> are engaged with the first locking groove <NUM> of the core sleeve <NUM>, to a first actuated position (<FIG>), in which the protrusions <NUM> of the locking sleeve <NUM> are engaged with the second locking groove <NUM> of the core sleeve <NUM>. This applied force therefore causes the protrusions <NUM> of the locking sleeve <NUM> to slide along the second and third flanges <NUM>, <NUM> and snap into engagement with the second locking groove <NUM> of the core sleeve <NUM>. As a result, the first biasing element <NUM> is further compressed from an initial compressed position (<FIG>) to a first compressed position (<FIG>).

Further, during this translation, the core sleeve <NUM> slides between the indicator rod <NUM> and the upper segment 114a of the outer sleeve <NUM>. As a result, when the core sleeve <NUM> is in the first actuated position (<FIG>), the core sleeve <NUM> blocks the first indicator window 118a thereby indicating the release of the first simulated dose of the drug. Once the core sleeve <NUM> has reached its first actuated position, the user can release the plunger <NUM> and allow the second biasing element <NUM> to push the plunger <NUM> back in a reverse axial direction (A<NUM>) to its start position (<FIG>). As the plunger <NUM> returns to its start position, the three cantilever arms <NUM> ride over a set of three ramped protrusions <NUM> on a lower section <NUM> of the core sleeve <NUM>.

While not shown, prior to the second stage of operation, a user removes the tip <NUM> from their first nostril and inserts the tip <NUM> of the outer sleeve <NUM> into their second nostril until the depth guide <NUM> contacts the skin between their first and second nostrils, such that the longitudinal axis (LA) of the device <NUM> is aligned with the axis of the second nostril. Further, prior to insertion, in some embodiments, the user can tilt their head about <NUM> degrees relative to their neck (e.g., <NUM> degrees backwards from a user's vertical).

During the second stage of operation, the user applies a second actuation force to the first end 112a of the plunger <NUM> in the axial direction (A<NUM>) toward the upper segment 114a of the outer sleeve <NUM>. The user can apply this force with their thumb in opposition to their fingers on the finger rest <NUM>. This applied force first causes the cantilever arms <NUM> of the plunger <NUM> to push against the three ramped protrusions <NUM> on the core sleeve <NUM>. Once the second applied force exceeds the second threshold force, the plunger <NUM> axially translates the core sleeve <NUM> from its first actuated position (<FIG>), in which the protrusions <NUM> of the locking sleeve <NUM> are engaged with the second locking groove <NUM> of the core sleeve <NUM>, to its second actuated position (<FIG>), in which the protrusions <NUM> of the locking sleeve <NUM> are engaged with the third locking groove <NUM> of the core sleeve <NUM>. This applied force therefore causes the protrusions <NUM> of the locking sleeve <NUM> to slide along the fourth flange <NUM> and snap into engagement with the third locking groove <NUM>. As a result, the first biasing element is further compressed from its first compressed position (<FIG>) to a second compressed position (<FIG>).

Further, during this translation, the core sleeve <NUM> further slides between the indicator rod <NUM> and the upper segment 114a of the outer sleeve <NUM>. As a result, when the core sleeve <NUM> is in the second actuated position, the core sleeve <NUM> blocks both the first and second indicator windows 118a, 118b such that the indicator rod <NUM> is not visible. This indicates the release of the second simulated dose of the drug, and thus the completion of both simulated doses. Once the core sleeve <NUM> has reached its second actuated position, the user can release the plunger <NUM> and allow the second biasing element <NUM> to push the plunger <NUM> back in a reverse axial direction to its start position (<FIG>).

Once the outer sleeve <NUM> is removed from the second nostril, the user can carry out the third stage of operation. The third stage of operation resets the device <NUM>. Once the core sleeve <NUM> is in the second actuated position, the plunger <NUM> can be rotated about the longitudinal axis (LA) of the device <NUM> relative to the outer sleeve <NUM> (e.g., in a clockwise direction when viewed from the first end 162a of the plunger <NUM>), and thus against the torque of the second biasing element <NUM>.

During the third stage of operation, in which the core sleeve <NUM> begins in the second actuated position, rotation of the plunger <NUM> about the longitudinal axis (LA) of the device <NUM> resets the core sleeve <NUM> to the start position such that the core sleeve <NUM> can axially translate back to the first and second actuated positions. In this illustrated embodiment, the actuated radial position of the plunger <NUM> can be achieved by rotating the plunger <NUM> by a certain amount, such as about <NUM> degrees from its initial radial position. In other embodiments, the actuated radial position of the plunger <NUM> can be achieved by rotating the plunger <NUM> about <NUM> degrees from its initial radial position, or by an amount between <NUM>-<NUM> degrees. A person skilled in the art will appreciate that any amount of rotation to rotate the plunger <NUM> from its initial radial position to its actuated radial position may be possible and depends at least upon the structural configurations of the locking sleeve <NUM>, the core sleeve <NUM>, and the plunger <NUM>.

During the third stage of operation, a rotational force is applied to the plunger <NUM> that exceeds a rotational biasing force (torque) of the second biasing element <NUM> to thereby rotate the plunger <NUM> in a first rotational direction relative to the outer sleeve <NUM> (e.g., a clockwise direction) when viewed from the first end of the plunger <NUM> from its initial radial position to its actuated radial position. After a first degree of rotation of the plunger <NUM> (e.g., about <NUM> degrees) towards its actuated radial position (<FIG>), the cantilever arms <NUM> are rotated such that they are out of axial alignment with the fifth flange <NUM> and the three ramped protrusions <NUM> on the core sleeve <NUM>. Also at this point of rotation, the three rib features <NUM> of the plunger <NUM> (see <FIG>) make contact with the three rib features <NUM> on the core sleeve <NUM> (see <FIG>). As a result, the plunger <NUM> and the core sleeve <NUM> concurrently rotate through the second degree of rotation (e.g., about <NUM> degrees) until the plunger <NUM> reaches its actuated radial position (<FIG>). During this second degree of rotation, the core sleeve <NUM> rotates relative to the locking sleeve <NUM> such that the protrusions <NUM> of the locking sleeve <NUM> move into axially-aligned channels <NUM> (see <FIG>) on the core sleeve <NUM>. This allows the first biasing element <NUM> to push the core sleeve <NUM> back in a second, axial direction towards its start position. At this point, the indicator rod <NUM> is now visible through both indicator windows 118a, 118b of the upper segment 114a of the outer sleeve <NUM>. When the plunger <NUM> is released, the second biasing element <NUM> rotates the plunger <NUM> in a second, opposing rotational direction so that the plunger returns to its initial radial position, and during this rotation the plunger <NUM> rotates the core sleeve <NUM> back to its start position (<FIG>).

In some embodiments, the indicator rod <NUM> can be a different color than the core sleeve <NUM> so as to aid the user in visually verifying the position of the core sleeve <NUM>. That is, the difference in color of the indicator rod and the core sleeve can help visually indicate to the user that the core sleeve is in the start position, the first actuated position, and the second actuated positions.

Once the user becomes familiar with using the training device <NUM>, the training device <NUM> can be disposed. As such, the training device <NUM> is configured to be used multiple times by a single user. In other embodiments, the training device <NUM> can be configured to be used multiple times by multiple users.

<FIG> illustrates another exemplary embodiment of a training device <NUM> that can be used multiple times by multiple users. The training device <NUM> is structurally and operationally similar to training device <NUM> in <FIG> except that the upper segment 814a of the outer sleeve <NUM> culminates at a truncated tip <NUM>. As shown in <FIG>, this truncated tip <NUM> does not extend past the depth guide <NUM>, and therefore during use, the truncated tip <NUM> is not inserted into any nostril of the user. Instead, prior to the first stage of operation, a user can position the device <NUM> to a first side of their head such that their hand and wrist are in similar positions as if the truncated tip <NUM> was placed in their first nostril. That is, a user can place the device <NUM> to the first side of their head at a position in which the truncated tip <NUM> is laterally aligned with the position of their first nostril and the depth guide <NUM> is laterally aligned with the position of their skin between their first and second nostrils. Likewise, prior to the second stage of operation, a user can position the device <NUM> to a second side of their head such that their hand and wrist are in similar positions as if the truncated tip <NUM> was placed in their second nostril. That is, a user can place the device <NUM> to the second side of their head at a position in which the truncated tip <NUM> is laterally aligned with the position of their second nostril and the depth guide <NUM> is laterally aligned with the position of their skin between their first and second nostrils. Once the user is familiar with the operational steps of the device <NUM>, the device <NUM> can be returned, e.g., to a health care provider who may clean it (using sterilizing alcohol wipes or similar) and store it for the next user.

<FIG> illustrate another exemplary embodiment of a training device <NUM> that can be used multiple times by multiple users. The training device <NUM> is structurally and operational similar to training device <NUM> except that the device <NUM> includes a protective hygiene cap <NUM> that is selectively mateable with and removeable from the device <NUM>. Prior to use of the device <NUM>, the protective hygiene cap <NUM> can be placed over and mated to the tip <NUM> of the training device <NUM> such that the tip <NUM>, depth guide <NUM>, and the finger rest <NUM> are protected by the cap <NUM>. The cap <NUM> includes two snapping arms <NUM>, <NUM> that are configured to snap into position over the ends 995a, 995b of the opposing flanges 926a, 926b of the finger rest <NUM> to thereby secure the cap to the device <NUM>.

As further shown, the cap <NUM> includes a tip <NUM> that shares the same profile as the tip <NUM> of training device <NUM> shown in <FIG>, such that when the cap <NUM> is coupled to the finger rest <NUM>, the tip <NUM> can be similarly inserted into the nostrils of a user as discussed above. Therefore, when the cap is coupled to the device <NUM>, the user can practice all the operational steps of the device <NUM>, including insertion into the nostrils. However, in this illustrated embodiment, the training device <NUM> itself remains free from contact with the nose and fingertips of the user and therefore, the device <NUM> remains hygienically clean. When the user has practiced sufficiently and feels comfortable with the positioning and actuation process of the training device <NUM>, a health care provider can remove and dispose of the cap <NUM> before storing the training device <NUM> for subsequent use by a different user.

Further, this training device can be provided with more than one protective hygiene cap <NUM>. In such embodiments, once all caps have been exhausted, the device can be disposed of and replaced with a complete new device and corresponding protective hygiene caps. As a result, degradation of the actuation mechanism of the device can be managed by the number of caps supplied with the device. This can prevent a user from using an overused device that does not provide the proper tactical experience during use. Moreover, using protective hygiene caps allows for fewer devices to be used and disposed of compared to those without protective hygiene caps.

While the hygiene cap <NUM> is primarily described with respect to the embodiments of <FIG>, a person skilled in the art will understand that the hygiene cap <NUM> can likewise be used with the embodiments of <FIG>, making any modifications that will ensure the appropriate fit of the hygiene cap <NUM>.

The devices disclosed herein can be formed of one or more polymers, e.g. polycarbonate, that are known to those skilled in the art. In some embodiments, the first and second biasing elements can be formed of one or more metals such as spring steel.

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 pieces and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts 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 either at a reconditioning facility, or by a health care provider immediately prior to use. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly.

It will be appreciated that the terms "proximal" and "distal" are used herein with reference to a user gripping a plunger of a device. Other spatial terms such as "front" and "rear" similarly correspond respectively to distal and proximal. It will be further appreciated that for convenience and clarity, spatial terms such as "vertical" and "horizontal" are used herein with respect to the drawings. However, devices are used in many orientations and positions, and these spatial terms are not intended to be limiting and absolute.

Values or ranges may be expressed herein as "about" and/or from/of "about" one particular value to another particular value. When such values or ranges are expressed, other embodiments disclosed include the specific value recited and/or from/of the one particular value to another particular value. Similarly, when values are expressed as approximations, by the use of antecedent "about," it will be understood that here are a number of values disclosed therein, and that the particular value forms another embodiment. It will be further understood that there are a number of values disclosed therein, and that each value is also herein disclosed as "about" that particular value in addition to the value itself. In embodiments, "about" can be used to mean, for example, within <NUM>% of the recited value, within <NUM>% of the recited value or within <NUM>% of the recited value.

For purposes of describing and defining the present teachings, it is noted that unless indicated otherwise, the term "substantially" is utilized herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. The term "substantially" is also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.

Claim 1:
A training device for simulating intranasal drug delivery, the device comprising:
an outer sleeve (<NUM>) having upper and lower portions;
a locking sleeve (<NUM>) coupled to the outer sleeve and partially extending therethrough;
a core sleeve (<NUM>) coupled to the locking sleeve and configured to axially slide within the outer and locking sleeves, the core sleeve having first (<NUM>) and second (<NUM>) sets of locking features; and
a plunger (<NUM>) operatively coupled to the core sleeve, the plunger being configured to selectively translate the core sleeve from an initial position to a first actuated position that indicates the release of a first simulated dose of a drug, and the plunger being configured to translate the core sleeve from the first actuated position to a second actuated position that indicates the release of a second simulated dose of the drug;
wherein the device does not contain a drug.