TRAINING DEVICES AND METHODS FOR SIMULATING INTRANASAL DRUG DELIVERY

Various training devices and methods for simulating intranasal drug delivery are described. In one exemplary embodiment, a 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 operatively 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 that indicates the release of a first simulated dose of a drug, and 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 the drug. The plunger can also be configured to rotate relative to the outer sleeve to reset the core sleeve to the initial position such that the core sleeve can be translated back to the first and second actuated positions.

FIELD

Training devices and methods are disclosed for simulating intranasal drug delivery.

BACKGROUND

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 45°; 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.

SUMMARY

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

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.

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 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.

DETAILED DESCRIPTION

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 U.S. Pat. Nos. 9,555,950, 7,299,949, and 6,321,942, each of which is hereby incorporated by reference in its entirety.

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.

FIGS.1A-2Billustrate an exemplary embodiment of a training device100that is configured to simulate intranasal drug delivery. The device100includes an outer sleeve102, a depth guide104, a finger rest106, a locking sleeve108, a core sleeve110, and a plunger112.

While the outer sleeve102can have a variety of configurations, the outer sleeve102, as shown inFIG.1D, includes upper and lower segments114a,114b. The upper and lower segments114a,114beach have a cylindrical structure. As shown, the upper segment114aculminates in a tip115. The tip115is configured to be inserted into a first nostril during the first stage of operation of the device100and a second nostril during the second stage of operation of the device100. In other embodiments, the upper and lower segments114a,114bcan have other suitable structural configurations.

As shown inFIGS.1A,1D and2A-2B, the upper segment114aof the outer sleeve102includes an indicator frame116that surrounds two indicator windows118a,118b. In this illustrated embodiment, the indicator frame116has an oblong-shaped configuration and the two indicator windows118a,118beach have a circular-shaped configuration. In other embodiments, the indicator frame116and the two indicator windows118a,118bcan have other suitable shaped configurations. As further shown inFIGS.1D and2A-2B, an indicator rod120is disposed within the outer sleeve102and partially extends through the upper segment114asuch that it overlaps with the two indicator windows118a,118b. As explained in more detail below, the indicator rod120is visible through the two indicator windows118a,118bprior to actuation of the device100. That is, the visibility of the indicator rod120through both of these indicator windows118a,118bindicates to the user that the device100is in the start position. Further, in some embodiments, the indicator rod120can have a first color that is different than the color of the upper segment114aof the outer sleeve102so as to enhance the visibility of the indicator rod120through the indicator windows118a,118b. For example, prior to any actuation and when the device100is ready for use, the indicator windows118a,118bcan show a color such as green. After the first actuation the indicator window118acan show a different color such as white and after the second actuation the indicator window118bcan likewise show the color white.

As shown inFIGS.1A,1D and2A-2B, the depth guide104is conjoined to the finger rest106via an elongated tubular body122. The depth guide104includes a first set of opposing flanges124a,124bextending from a first end122aof the elongated tubular body122. The first set of opposing flanges124a,124bare configured to limit the insertion depth of the upper segment114aof the outer sleeve102into a user's nostril. The finger rest106includes a second set of two opposing flanges126a,126bextending from a second, opposing end122bof the elongated tubular body122. The finger rest106acts 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 device100while depressing the plunger112toward the upper segment114aof the outer sleeve102using their thumb. The elongated tubular body122includes an oblong shaped hole128that corresponds to the indicator frame116of the upper segment114aof the outer sleeve102. As such, when the elongated tubular body122, and consequently the depth guide104and finger rest106, are positioned about a portion of the upper segment114aof the outer sleeve102, as shown inFIG.1A, the indicator frame116extends through the oblong-shaped hole128of the elongated tubular body122to retain its position.

The locking sleeve108has an annular collar130that is coupled between the upper and lower segments114a,114bof the outer sleeve102, thereby forming a shoulder132. This coupling engagement retains the locking sleeve108in an immobile position within the outer sleeve102. The locking sleeve108also includes snap arms134extending proximally from the annular collar130and partially through the lower segment114bof the outer sleeve102. While the number of snap arms134can vary, in this illustrated embodiment, the locking sleeve108includes three snap arms134oriented parallel to and arranged equally about the longitudinal axis (LA) of the device100. Each snap arm134includes an inward-facing protrusion136, only one of which is shown, that is configured to engage locking features on the core sleeve110. As such, the snap arms134can simultaneously flex outwardly when a conical profile is forced upwardly towards the upper segment114aof the outer sleeve102and over inward-facing protrusions136.

While the protrusions136can have a variety of configurations, as shown inFIGS.1D and2A-2B, the protrusions136each include at least a ramped surface136aand a planar surface136b. The planar surface136bsurface extends in a direction that is orthogonal to the longitudinal axis of the device100. As will be discussed in more detail below, the ramped surface136aof each protrusion136is configured to slide over flanges (such as second, third, and fourth flanges144,150, and152) on the core sleeve110during the first and second stages of operation to allow for axial translation of the core sleeve110relative to the locking sleeve108and the planar surface136bis configured to engage locking grooves (such as first, second, and third locking grooves146,154, and160) on the core sleeve to lock the core sleeve in various positions.

As shown inFIGS.1D and2A-2B, and in more detail inFIGS.3A and3B, the core sleeve110extends from an open end110ato a closed end110b. A first biasing element138is retained within and compressed between the closed end110bof the core sleeve110and an end120aof the indicator rod120. While the first biasing element138can have a variety of configurations, in this illustrated embodiment, the first biasing element138is a helical spring. The core sleeve110includes first sets of locking features140. The first sets of locking features140in combination with the partial compression of the first biasing element138couples the core sleeve to the locking sleeve108. Thus, the first biasing element138is configured to bias the core sleeve110to its initial position. As used herein, the term “initial position” is used synonymously with the term “start position.”

The first sets of locking features140are positioned proximal to the open end110aof the core sleeve110. In this illustrated embodiment, the core sleeve110includes three first sets of locking features140that are substantially similar in structural configuration and configured to engage one corresponding protrusion136of one snap arm134of the locking sleeve108. As such, for sake of simplicity, the following discussion is with respect to one of the first sets of locking features140. A person skilled in the art will understand, however, that the following discussion is also applicable to the remaining first sets of locking features140. Further, in other embodiments, the core sleeve110can include less than or greater than three first sets of locking features140.

While the first set of locking features140can have a variety of structural configurations, the first set of locking features140as shown inFIGS.2A-3B, includes first and second flanges142,144extending from the outer surface111aof the core sleeve110and a first locking grove146defined therebetween. As shown, the first and second flanges142,144each include at least a ramped surface142a,144aand a planar surface144a,144b. The planar surface144a,144bextends in a direction orthogonal to the longitudinal axis of the device100. The core sleeve110is therefore held in its start position by the first set of locking features140that interact with the protrusion136of the locking sleeve108. That is, after assembling the device100, the protrusion136of the locking sleeve108engages with the first locking groove146defined between the first and second flanges142,144and is maintained in that position until a user actuates the device100during the first stage of operation.

Further, the ramped surface142aof the second flange144has a ramp profile that is structurally designed such that during use, a certain amount of force needs to be applied to the core sleeve110before the ramp profile forces the snap arms134outwards at which point the core sleeve110can move freely towards the tip115of the device100and into a first actuated position. That is, the axial force (first actuation force) that is applied to the core sleeve110must exceed a first force threshold to allow the core sleeve110to be axially translated via the plunger112to 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 ±20%.

The core sleeve110can include additional sets of locking features. For example, as shown inFIGS.1D and2A-2B, the core sleeve110includes second sets of locking features148, which, as will be discussed in more detail, maintain the core sleeve110in a first actuated position. In this illustrated embodiment, the core sleeve110includes three second sets of locking features148that are substantially similar in structural configuration and configured to engage one corresponding protrusion136of one snap arm134of the locking sleeve108. As such, for sake of simplicity, the following discussion is with respect to one of the second sets of locking features148. A person skilled in the art will understand, however, that the following discussion is also applicable to the remaining second sets of locking features148. Further, in other embodiments, the core sleeve110can include less than or greater than three second sets of locking features148.

While the second set of locking features148can have a variety of structural configurations, the second set of locking features148, as shown inFIGS.2A-3B, includes third150and fourth flanges152extending from the outer surface111aof the core sleeve110and a second locking groove154defined therebetween. As shown, the third150and fourth flanges152each include at least a ramped surface150a,152aand a planar surface150b,152b. The planar surface150b,152bextends in a direction that is orthogonal to the longitudinal axis (LA) of the device100. The core sleeve110is therefore held in a first actuated position by the second set of locking features148that interact with the protrusion136of the locking sleeve108. That is, the protrusion136of the locking sleeve108engages with the second locking groove154defined between the third150and fourth flanges152, and is maintained in that position until a user actuates the device100during the second stage of operation.

The ramped surface150aof the third flange150has a ramp profile that is smaller than the ramp profile of the ramped surface144aof the second flange144. The smaller diameter of this ramp profile ensures that the user does not need to apply an increased force to the core sleeve110to slide over the ramped surface150aof the third flange150. That is, the first actuation force is sufficient to slide the core sleeve110from its initial position to its first actuated position.

Further, the ramped surface152aof the fourth flange152has a ramp profile that is structurally designed such that during use, a certain amount of force needs to be applied to the core sleeve110before the ramp profile forces the snap arms134outwardly at which point the core sleeve110can move freely and further towards the tip115of the device100and into a second actuated position. That is, the axial force (second actuation force) applied to the core sleeve110must exceed a second force threshold to allow the core sleeve110to be axially translated via the plunger112to 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 ±20%.

The core sleeve110can also include third sets of locking features156, which, as will be discussed in more detail, maintain the core sleeve110in a second actuated position. In this illustrated embodiment, the core sleeve110includes three third sets of locking features156that are substantially similar in structural configuration and configured to engage one corresponding protrusion of one snap arm134of the locking sleeve108. As such, for sake of simplicity, the following discussion is with respect to one of the third sets of locking features156. A person skilled in the art will understand, however, that the following discussion is also applicable to the remaining third sets of locking features156. Further, in other embodiments, the core sleeve110can include less than or greater than three third sets of locking features156.

While the third set of locking features156can have a variety of structural configurations, as shown inFIGS.2A-3B, the third set of locking features156includes the fourth flange152and a fifth flange158extending from the outer surface111aof the core sleeve110and a third locking grove160defined therebetween. As shown, the fifth flange158also includes at least a ramped surface158aand a planar surface158b. The planar surface158bextends in a direction that is orthogonal to the longitudinal axis (LA) of the device100. The core sleeve110is therefore held in a second actuated position by the third set of locking features156that interact with the protrusion136of the locking sleeve108. That is, the protrusion136of the locking sleeve108engages with the third locking groove160defined between the fourth and fifth flanges152,158, and is maintained in that position until a user resets the device100during the third stage of operation.

Further, as shown inFIGS.2A-2B, the plunger112is operatively coupled to the core sleeve110and configured to axially translate relative to the outer sleeve102to selectively slide the core sleeve110from 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 device100, respectively. The plunger112is also configured to rotate relative to the outer sleeve102between an initial radial position and an actuated radial position to reset the device100after completion of the second stage of operation. While the plunger112can have a variety of configurations, the plunger112, in this illustrated embodiment has an elongated tubular configuration extending from a first end162ato a second end162b. The plunger112also includes three equally spaced cantilever arms164, as shown inFIG.5. The cantilever arms164, two of which are obstructed inFIGS.2A-2B, are arranged radially from the first end162aof the plunger112and extending towards the core sleeve110. The plunger112can also include gripping features163to aid in rotation of the plunger112, as shown inFIGS.1A,2A-2B, and4.

A second biasing element166sits partially within the lower segment114bof the outer sleeve102, surrounding the locking and core sleeves108,110. While the second biasing element166can have a variety of configurations, in this illustrated embodiment, the second biasing element166is a helical spring. The ends166a,166bof this second biasing element166are each configured as a short tail that is parallel to the longitudinal axis (LA) of the device100. As shown, the first end166ainteracts with the shoulder132formed by the annular collar130of the locking sleeve108and the upper and lower segments114a,114bof the outer sleeve102such that the second biasing element166cannot freely rotate about the longitudinal axis of the device100.

As shown inFIGS.2A-2B, the plunger112is fitted over and partially compresses the second biasing element166. While not shown, during assembly, the second end166bof the second biasing element166engages with a rib on the inner surface113aof the plunger112. As a result, when the plunger112is fitted over the second biasing element166, it is rotated clockwise about the longitudinal axis (LA) of the device100, thereby applying torsion to the second biasing element166. As such, the second biasing element166biases the plunger112to an initial radial position, as shown inFIGS.2A-2B.

Further, the plunger112is partially disposed within the lower segment114bof the outer sleeve102and coupled thereto by a locking ring168. The plunger112, as shown in more detail inFIG.4, includes three equally-spaced lugs169on outer surface113bof the plunger112and positioned at the second end112bof the plunger112. The three lugs169each have a L-shaped configuration (seeFIG.4). As further shown inFIG.5, the plunger112also includes three equally spaced axially-aligned rib features165on the inner surface113aof the plunger112. These rib features165are configured to engage corresponding rib features171on the core sleeve110such that the plunger112and the core sleeve110rotate together during a portion of the third stage of operation. As discussed below, this engagement allows the core sleeve110to disengage from, and rotate relative to, the locking sleeve108during a portion of the third stage of operation.

The plunger112is partially disposed within the lower segment114bof the outer sleeve102so that the three lugs169are positioned within corresponding, axially-aligned channels117, two of which are shown inFIG.2A, on the inner surface of the lower segment114bof the outer sleeve102. As a result, during use, the plunger112can be depressed axially so that the three lugs169run along the channels117as the second biasing element166is compressed. Further, when the plunger112is 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 element166. The second biasing element166therefore serves a dual purpose of returning the plunger112axially 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 device100has three stages of operation, in which the first stage of operation is illustrated inFIGS.6A-6C, the second stage of operation is illustrated inFIGS.6D and6E, and the third stage of operation is illustrated inFIGS.7A-7C. In general, the first stage of operation involves axial translation of the core sleeve110to 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 sleeve110to mimic a second spray of the drug from the intranasal drug delivery device, and the third stage of operation involves rotation of the plunger112to axially reset the device100, and thus the core sleeve110, 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 tip115of the outer sleeve102into their first nostril until the depth guide104contacts the skin between their first and second nostrils, such that the longitudinal axis (LA) of the device100is aligned with the axis of the first nostril. Further, prior to insertion, in some embodiments, the user can tilt their head about 45 degrees relative to their neck.

During the first stage of operation, the user applies a first actuation force to the first end112aof the plunger112in an axial direction (A1) toward the upper segment114aof the outer sleeve102. The user can apply this force with their thumb in opposition to their fingers on the finger rest106. This applied force first causes the cantilever arms164of the plunger112to push against the planar surface158bof the fifth flange158on the core sleeve110. Once the applied force exceeds a first threshold force, the plunger112axially translates the core sleeve110from its start position (FIG.6A), in which the protrusions136of the locking sleeve108are engaged with the first locking groove146of the core sleeve110, to a first actuated position (FIGS.6B and6C), in which the protrusions136of the locking sleeve108are engaged with the second locking groove154of the core sleeve110. This applied force therefore causes the protrusions136of the locking sleeve108to slide along the second and third flanges144,150and snap into engagement with the second locking groove154of the core sleeve110. As a result, the first biasing element138is further compressed from an initial compressed position (FIG.6A) to a first compressed position (FIGS.6B and6C).

Further, during this translation, the core sleeve110slides between the indicator rod120and the upper segment114aof the outer sleeve102. As a result, when the core sleeve110is in the first actuated position (FIGS.6B and6C), the core sleeve110blocks the first indicator window118athereby indicating the release of the first simulated dose of the drug. Once the core sleeve110has reached its first actuated position, the user can release the plunger112and allow the second biasing element166to push the plunger112back in a reverse axial direction (A2) to its start position (FIG.6C). As the plunger112returns to its start position, the three cantilever arms164ride over a set of three ramped protrusions170on a lower section172of the core sleeve110.

While not shown, prior to the second stage of operation, a user removes the tip115from their first nostril and inserts the tip115of the outer sleeve102into their second nostril until the depth guide104contacts the skin between their first and second nostrils, such that the longitudinal axis (LA) of the device100is aligned with the axis of the second nostril. Further, prior to insertion, in some embodiments, the user can tilt their head about 45 degrees relative to their neck (e.g., 45 degrees backwards from a user's vertical).

During the second stage of operation, the user applies a second actuation force to the first end112aof the plunger112in the axial direction (A1) toward the upper segment114aof the outer sleeve102. The user can apply this force with their thumb in opposition to their fingers on the finger rest106. This applied force first causes the cantilever arms164of the plunger112to push against the three ramped protrusions170on the core sleeve110. Once the second applied force exceeds the second threshold force, the plunger112axially translates the core sleeve110from its first actuated position (FIGS.6B and6C), in which the protrusions136of the locking sleeve108are engaged with the second locking groove154of the core sleeve110, to its second actuated position (FIG.6D), in which the protrusions136of the locking sleeve108are engaged with the third locking groove160of the core sleeve110. This applied force therefore causes the protrusions136of the locking sleeve108to slide along the fourth flange152and snap into engagement with the third locking groove160. As a result, the first biasing element is further compressed from its first compressed position (FIGS.6B and6C) to a second compressed position (FIGS.6D and6E).

Further, during this translation, the core sleeve110further slides between the indicator rod120and the upper segment114aof the outer sleeve102. As a result, when the core sleeve110is in the second actuated position, the core sleeve110blocks both the first and second indicator windows118a,118bsuch that the indicator rod120is 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 sleeve110has reached its second actuated position, the user can release the plunger112and allow the second biasing element166to push the plunger112back in a reverse axial direction to its start position (FIG.6E).

Once the outer sleeve102is removed from the second nostril, the user can carry out the third stage of operation. The third stage of operation resets the device100. Once the core sleeve110is in the second actuated position, the plunger112can be rotated about the longitudinal axis (LA) of the device100relative to the outer sleeve102(e.g., in a clockwise direction when viewed from the first end162aof the plunger112), and thus against the torque of the second biasing element166.

During the third stage of operation, in which the core sleeve110begins in the second actuated position, rotation of the plunger112about the longitudinal axis (LA) of the device100resets the core sleeve110to the start position such that the core sleeve110can axially translate back to the first and second actuated positions. In this illustrated embodiment, the actuated radial position of the plunger112can be achieved by rotating the plunger112by a certain amount, such as about 120 degrees from its initial radial position. In other embodiments, the actuated radial position of the plunger112can be achieved by rotating the plunger112about 90 degrees from its initial radial position, or by an amount between 90-120 degrees. A person skilled in the art will appreciate that any amount of rotation to rotate the plunger112from its initial radial position to its actuated radial position may be possible and depends at least upon the structural configurations of the locking sleeve108, the core sleeve110, and the plunger112.

During the third stage of operation, a rotational force is applied to the plunger112that exceeds a rotational biasing force (torque) of the second biasing element166to thereby rotate the plunger112in a first rotational direction relative to the outer sleeve102(e.g., a clockwise direction) when viewed from the first end of the plunger112from its initial radial position to its actuated radial position. After a first degree of rotation of the plunger112(e.g., about 40 degrees) towards its actuated radial position (FIG.7A), the cantilever arms164are rotated such that they are out of axial alignment with the fifth flange158and the three ramped protrusions170on the core sleeve110. Also at this point of rotation, the three rib features165of the plunger112(seeFIG.5) make contact with the three rib features171on the core sleeve110(seeFIGS.3A-3B). As a result, the plunger112and the core sleeve110concurrently rotate through the second degree of rotation (e.g., about 50 degrees) until the plunger112reaches its actuated radial position (FIG.7B). During this second degree of rotation, the core sleeve110rotates relative to the locking sleeve108such that the protrusions136of the locking sleeve108move into axially-aligned channels173(seeFIGS.3A-3B) on the core sleeve110. This allows the first biasing element138to push the core sleeve110back in a second, axial direction towards its start position. At this point, the indicator rod120is now visible through both indicator windows118a,118bof the upper segment114aof the outer sleeve102. When the plunger112is released, the second biasing element166rotates the plunger112in a second, opposing rotational direction so that the plunger returns to its initial radial position, and during this rotation the plunger112rotates the core sleeve110back to its start position (FIG.7C).

In some embodiments, the indicator rod120can be a different color than the core sleeve110so as to aid the user in visually verifying the position of the core sleeve110. 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 device100, the training device100can be disposed. As such, the training device100is configured to be used multiple times by a single user. In other embodiments, the training device100can be configured to be used multiple times by multiple users.

FIG.8illustrates another exemplary embodiment of a training device800that can be used multiple times by multiple users. The training device800is structurally and operationally similar to training device100inFIGS.1A-7Cexcept that the upper segment814aof the outer sleeve802culminates at a truncated tip815. As shown inFIG.8, this truncated tip815does not extend past the depth guide804, and therefore during use, the truncated tip815is not inserted into any nostril of the user. Instead, prior to the first stage of operation, a user can position the device800to a first side of their head such that their hand and wrist are in similar positions as if the truncated tip815was placed in their first nostril. That is, a user can place the device800to the first side of their head at a position in which the truncated tip815is laterally aligned with the position of their first nostril and the depth guide804is 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 device800to a second side of their head such that their hand and wrist are in similar positions as if the truncated tip815was placed in their second nostril. That is, a user can place the device800to the second side of their head at a position in which the truncated tip815is laterally aligned with the position of their second nostril and the depth guide804is 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 device800, the device800can 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.

FIGS.9A and9Billustrate another exemplary embodiment of a training device900that can be used multiple times by multiple users. The training device900is structurally and operational similar to training device800except that the device900includes a protective hygiene cap990that is selectively mateable with and removeable from the device900. Prior to use of the device900, the protective hygiene cap990can be placed over and mated to the tip915of the training device900such that the tip915, depth guide904, and the finger rest906are protected by the cap990. The cap990includes two snapping arms992,994that are configured to snap into position over the ends995a,995bof the opposing flanges926a,926bof the finger rest906to thereby secure the cap to the device900.

As further shown, the cap990includes a tip996that shares the same profile as the tip115of training device100shown inFIGS.1A-7C, such that when the cap990is coupled to the finger rest906, the tip996can be similarly inserted into the nostrils of a user as discussed above. Therefore, when the cap is coupled to the device900, the user can practice all the operational steps of the device900, including insertion into the nostrils. However, in this illustrated embodiment, the training device900itself remains free from contact with the nose and fingertips of the user and therefore, the device900remains hygienically clean. When the user has practiced sufficiently and feels comfortable with the positioning and actuation process of the training device900, a health care provider can remove and dispose of the cap990before storing the training device900for subsequent use by a different user.

Further, this training device can be provided with more than one protective hygiene cap990. 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 cap990is primarily described with respect to the embodiments ofFIGS.8-9B, a person skilled in the art will understand that the hygiene cap990can likewise be used with the embodiments ofFIGS.1-7C, making any modifications that will ensure the appropriate fit of the hygiene cap990.

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.

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 10% of the recited value, within 5% of the recited value or within 2% 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.

One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be 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, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this document. As such, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference.

The following is a non-exhaustive list of embodiments that may or may not be claimed.

1. A training device for simulating intranasal drug delivery, the device comprising:

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 being 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 the plunger being 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;

wherein 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

wherein the device does not contain the drug.

2. The device of embodiment 1, further comprising a protective hygiene cap that is selectively mateable with and removable from the device.
3. The device of embodiment 1, wherein the first sets 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, and wherein the first locking groove is configured to retain the core sleeve in the first actuated position.
4. The device of embodiment 3, wherein the second sets 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, and wherein the second locking groove is configured to retain the core sleeve in the second actuated position.
5. The device of embodiment 4, wherein the locking sleeve comprises at least two snap arms, each snap arm having a protrusion extending from an inner surface thereof and toward the core sleeve, wherein each protrusion is 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.
6. The device of embodiment 1, wherein the plunger returns to a start position after the application of the first actuation force and after the application of the second actuation force.
7. The device of embodiment 1, further comprising an indicator rod disposed within the upper portion of the outer sleeve, and wherein the indicator rod is viewable through first and second indicator windows of the upper portion when the core sleeve is in the initial position.
8. The device of embodiment 7, wherein the core sleeve is 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.
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.
10. A training device for simulating intranasal drug delivery, the device comprising:

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 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.

11. The device of embodiment 10, further comprising an indicator rod disposed within the upper portion of the outer sleeve, and wherein the indicator rod is viewable through first and second indicator windows of the upper portion when the core sleeve is in the initial position.
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 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.
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 to thereby indicate the release of the second simulated dose of the drug.
14. The device of embodiment 10, further comprising a protective hygiene cap that is selectively mateable with and removable from the outer sleeve.
15. The device of embodiment 10, wherein the first sets 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, and wherein the first locking groove is configured to retain the core sleeve in the first actuated position.
16. The device of embodiment 15, wherein the second sets 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, and wherein the second locking groove is configured to retain the core sleeve in the second actuated position.
17. The device of embodiment 16, wherein the locking sleeve comprises at least two snap arms, each snap arm having a protrusion extending from an inner surface thereof and toward the core sleeve, wherein each protrusion is 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.
18. The device of embodiment 10, wherein the plunger returns to a start position after the application of the first actuation force and after the application of the second actuation force.
19. A training device for simulating intranasal drug delivery, the device comprising:

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 and 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, the plunger being 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 axially translate back to the first and second axial positions.

20. The device of embodiment 19, further comprising a protective hygiene cap that is selectively mateable with and removable from the device.
21. The device of embodiment 19, wherein the core sleeve is configured to be repeatedly reset.
22. The device of embodiment 19, 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 a rotational biasing force of the first biasing element and thereby rotates the plunger in a first rotational direction.
23. The device of embodiment 22, wherein release of the rotational force allows the first biasing element to rotate the plunger in a second, opposite rotational direction to allow the plunger to return to the initial position.
24. The device of embodiment 22, further comprising a second biasing element that biases 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.
25. The device of embodiment 22, wherein, when the core sleeve is in the second axial position, rotation of the plunger in the first rotational direction causes the core sleeve to rotate and disengage from the locking sleeve.
26. The device of embodiment 25, wherein, when the core sleeve is disengaged from the locking sleeve, the second biasing element forces the core sleeve in a second, opposite axial direction from the second axial position toward the start position.
27. The device of embodiment 26, wherein release of the rotational force allows the first biasing element to rotate the plunger in a second, opposite rotational direction until the plunger reaches the initial position, and wherein rotation of the plunger in the second rotational direction rotates the core sleeve back to the start position.
28. A method for simulating intranasal drug delivery, the method comprising:

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;

wherein the device does not contain a drug.

29. The method of embodiment 28, further comprising, 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.
30. The method of embodiment 29, further comprising, 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.
31. The method of embodiment 28, wherein rotation of the plunger comprises:

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.

32. The method of embodiment 29, wherein, prior to depression of the plunger, an indicator rod disposed within an outer sleeve of the training device is viewable through first and second indicator windows of the outer sleeve.
33. The method of embodiment 32, wherein depressing the plunger to axially translate the core sleeve to the first actuated position causes 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.
34. The method of embodiment 33, wherein depressing the plunger to axially translate the core sleeve to the second actuated position causes 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.
35. The method of embodiment 34, wherein rotating the plunger causes 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.