Patent Description:
The present invention relates to a system for controlling the dispensing of medication, and, more specifically, to a system for dispensing medication through a time-controlled device linked to a web platform.

Conventional personal medication dispensing devices, such as intranasal spray devices, are often effectively used to deliver atomized medications. Traditional intranasal spray devices consist of a pump with an elongated nozzle which atomizes liquid as the liquid is propelled through the nozzle and out the delivery orifice. The resulting mist is inhaled and efficiently absorbed through the tissue, thereby providing an effective treatment.

Intranasal spray devices have been utilized to provide medication for conditions ranging from allergies, pain relief and depression. For conditions such as pain relief and depression, the risk of abuse associated with the medications provided within the device is high due to the addictive nature of medication treating those conditions. Ketamine, for example, has shown great effectiveness in treating serious conditions such as bipolar depression. However, given the addictive nature of medications such as ketamine, healthcare providers are hesitant to administer or otherwise prescribe them for home use. Healthcare providers are often concerned with patients abusing or misusing the medication, a person other than the patient abusing the medication, and theft and/or sale of the medication.

Abuse and misuse is not only attributed to the addictive nature of the medications but also the efficacy of the medication at delivering relief for the patient's condition. Patients may be driven to use more than their prescribed dosage due to the relief the medication provides. Consequently, patients in need of such medications may only receive a small dosage or supply per visit to a healthcare provider. As a result, some patients must visit their healthcare provider frequently, such as multiple times per week. Numerous required visits to a healthcare provider are not only inconvenient but can also act as a barrier to access to medication for those who cannot afford burdensome transportation or take extended time away from their place of employment.

<CIT> discloses a system for dispensing medication through a time controlled device linked to a web platform. The system includes a dispensing device in wireless communication with a computing device. A web platform on the computing device can be used to program the dispensing device with parameters such as the dosage number, minimum time period between dosages, and the like. Based on the programmed parameters, a solenoid in the dispensing device will lock or unlock based on dosages administered and the time between dosages.

<CIT> discloses a discharge device for media has a housing, an operating member manually movable relative to the housing and which, for performing a discharge can be transferred from an unoperated starting position in the direction of an operating direction into an operated end position and with a locking member, which is displaceable relative to the housing between a locked position where it prevents the displacement of the operating member into the end position and a release position in which it permits the displacement of the operating member into the end position.

The invention is defined in the independent claim <NUM>. Preferred embodiments are matter of the dependent claims.

Systems and methods are disclosed for dispensing medication with a locking dispensing device. The dispensing device can be shaped to form an exoskeleton around a medicinal vial. The dispensing device can include one or more locking mechanisms to prevent removal of the vial and/or administration of dosages. The system can include the dispensing device and a computing device that can be linked to the dispensing device to configure the dispensing devices' parameters (e.g. timeout, tampering detection, improper usage, biometric input, user authentication) for engaging and/disengaging the locking mechanisms.

The dispensing device can include a nozzle and a housing that can be integral or separable components that can be slidably engaged to each other to form an exoskeleton around the vial. The nozzle can include a housing interface configured to slidably engage the nozzle to the housing.

The dispensing device can include a vial lock that can be locked to prevent removal of the vial from the dispensing device and unlocked to allow removal of the dispensing device. In some examples, the vial lock can further include stops to limit movement of the nozzle in relation to the housing (e.g. set a completely extended position of the nozzle and/or completely depressed position of the nozzle). In examples where the nozzle is separable from the housing, the vial lock can further inhibit separation of the nozzle from the housing when locked and allow separation of the nozzle from the housing when unlocked.

The dispensing device can include a dose lock that can be locked to prevent movement of the nozzle in relation to the housing, thereby preventing administration of medication. The dose lock can be unlocked to allow the nozzle to be depressed into and/or extend out of the housing, thereby allowing administration of medication. In examples where the nozzle is separable from the housing, the dose lock, when locked, can further inhibit separation of the nozzle from the housing, and/or removal of the vial from the device.

The dispensing device can include sensors configured to detect partial depression of the nozzle and electrical circuitry configured to lock the dose lock in response to signals from the sensors. The sensors can include optical sensors positioned to view movement of the nozzle in relation to the housing.

In examples where the nozzle is separable from the housing, the nozzle can function together with a vial, absent the housing, to deliver medication. The housing can include the dose lock and the vial lock. The nozzle can include features to which the dose lock and/or vial lock can engage and lock. The housing can include sensors for detecting movement of the nozzle. The nozzle can include features thereon that are detectable by the sensors of the housing. The sensors and features on the nozzle can be positioned and otherwise configured to allow the device to detect partial depression of the nozzle.

The present invention will be more fully understood and appreciated by reading the following Detailed Description in conjunction with the accompanying drawings, in which:.

Referring to the Figures, the present technology may relate to a system, a method, and/or a computer program product. The computer program product may include a non-transitory computer readable storage medium (or media) having computer readable program instructions thereon for causing a processor to carry out aspects of the present invention.

Aspects of the present technology are described herein with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems), and computer program products according to exemplary embodiments.

The computer readable program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other device to cause a series of operational steps to be performed on the computer, other programmable apparatus or other device to produce a computer implemented process, such that the instructions which execute on the computer, other programmable apparatus, or other device implement the functions/acts specified in the flowchart and/or block diagram block orblocks.

The flowchart and block diagrams in the figures illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments.

Referring again to the drawings, wherein like reference numerals refer to like parts throughout, there is seen in <FIG> a perspective view of an embodiment of the system according to the present technology. <FIG> shows an embodiment of the system comprising a dispensing device <NUM> and a computing device <NUM>. The computing device <NUM> may be a smartphone, portable tablet, laptop computer, desktop computer, and any other like devices. <FIG> also shows the exterior components of an embodiment of the dispensing device <NUM>. The dispensing device <NUM> comprises a cylindrical housing <NUM> having a first closed end <NUM> and a second closed end <NUM>. A nozzle <NUM> extends perpendicular from a surface 104a of the first closed end <NUM>. The second closed end <NUM> may further comprise a baseplate 106a secured to the housing <NUM> with fasteners such as star screws, which will prevent easy tampering with the housing <NUM>. Other fasteners are contemplated such as magnetic fasteners, custom "keyed" screws, or similar locking devices. The housing <NUM> further comprises a recess <NUM> with a display screen <NUM> therein. The display screen may be a panel display, such as a monochrome OLED graphic display, or other LED displays, for example.

Referring to <FIG>, there is shown a schematic cross-sectional representation of an embodiment of the system in an unlocked position, taken along line A. <FIG> shows the interior components of the dispensing device <NUM> in an unlocked position wherein the nozzle <NUM> is depressed. The housing <NUM> of the dispensing device <NUM> further comprises a first portion <NUM> and a second portion <NUM>. The first portion <NUM> of the housing <NUM> is connected to both the first closed end <NUM> and the second portion <NUM>.

In the depicted embodiment, the second portion <NUM> of the housing <NUM> is connected to the second closed end <NUM> or the baseplate 106a and provides a base for the dispensing device <NUM>. The second portion <NUM> houses the liquid container <NUM>, which is configured to store liquid medicinal compositions. In the depicted embodiment, the liquid container <NUM> is cylindrical such to provide an efficient fit within the similarly cylindrical housing <NUM>. An example of a cylindrical liquid container <NUM> is a thread size stock vial.

In order to provide access to the medicinal contents of the liquid container <NUM>, the liquid container <NUM> comprises a pump assembly <NUM>. In the embodiment shown in <FIG>, the pump <NUM> is centrally located within the liquid container <NUM>. The pump assembly <NUM> is structured and operates substantially as standard pump assemblies used in conventional intranasal spray devices. As pressure is applied on the nozzle <NUM> towards the surface 104a of the first closed end <NUM>, the pump assembly <NUM> propels the liquid medical composition stored within the liquid container <NUM> through a channel <NUM> in the nozzle <NUM>, expelling the liquid medical composition from the dispensing device <NUM>. Thus, in an unlocked position, the liquid medical composition can be freely expelled from the dispensing device <NUM>.

Referring to <FIG>, there are shown schematic cross-sectional representations of an embodiment of the system in a locked position, taken along lines A and B, respectively. In the depicted embodiment, the first portion <NUM> of the housing <NUM> further comprises a solenoid <NUM> locking mechanism therein. The solenoid <NUM> operates perpendicular to the motion of the pump assembly <NUM>. In one embodiment, when the solenoid <NUM> is activated, it moves into the path of the nozzle <NUM> thereby blocking full movement of the nozzle <NUM> towards the surface 104a of the first closed end <NUM> and preventing the pump assembly <NUM> from expelling the liquid medicinal composition from the dispensing device <NUM>. The solenoid <NUM> is shown in an unlocked position in <FIG> and a locked position in <FIG>. In alternative embodiments, the solenoid <NUM> may comprise attachments such as a U-clip which blocks the path of the nozzle <NUM> and interrupts the motion of the pump assembly <NUM>.

Referring still to <FIG>, in the depicted embodiment, the solenoid <NUM> is activated in response to an electrical signal sent from a processor, such as a printed circuit board <NUM>. As shown in <FIG>, the printed circuit board <NUM> is located within the second portion <NUM> of the housing <NUM> towards the second closed end <NUM>. The printed circuit board <NUM> is operably connected to and powered by a battery <NUM> also located within the second portion <NUM> at the second closed end <NUM>. The battery <NUM> can be a rechargeable lithium ion battery or a similar type power source.

In an alternative embodiment, the locking mechanism is a motor assembly <NUM>. In <FIG>, there are shown various views of an embodiment of the motor assembly <NUM> locking mechanism. Referring first to <FIG>, a top perspective view of the motor assembly <NUM> is shown in the locked position. The motor assembly <NUM> comprises a motor <NUM> connected to a first gear <NUM>, which is positioned within an opening <NUM> of an internal gear wheel <NUM>. The internal gear wheel <NUM> comprises a central lock <NUM> with a keyway <NUM> extending therethrough. Similar to the embodiment wherein the locking mechanism is a solenoid <NUM> (<FIG>), the motor assembly <NUM> interrupts or otherwise blocks the motion of the pump assembly <NUM>. In the embodiment shown in <FIG>, the shaft <NUM> of a pump assembly <NUM> extends through the central lock <NUM> of the internal gear wheel <NUM>. To facilitate locking, there are one or more keys <NUM> protruding from the shaft <NUM> of the pump assembly <NUM>. The keys <NUM> are configured or otherwise fitted to slide into the keyway <NUM> of the central lock <NUM>. In the embodiment shown in <FIG>, the keys <NUM> rest on the central lock <NUM> and are blocked from sliding into the keyway <NUM>. Therefore, a nozzle <NUM> attached to the pump assembly <NUM> is not compressible when the keys <NUM> are not in alignment with the keyway <NUM>.

Referring now to <FIG>, there is shown a side perspective view and a top view of the motor assembly <NUM> in the unlocked position. From the locked position, shown in <FIG>, the motor <NUM> is activated by an electrical signal from the printed circuit board <NUM>, which rotates the gear <NUM> thereby rotating the internal gear wheel <NUM>. The opening <NUM> in the internal gear wheel <NUM> limits rotation of the internal gear wheel <NUM> as it may only rotate in either direction until it catches on the gear <NUM>. As the internal gear wheel <NUM> rotates, the lock <NUM> and keyway <NUM> rotate as well. The internal gear wheel <NUM> rotates until it is in the unlocked position, shown in <FIG>. In the unlocked position, the keys <NUM> of the shaft <NUM> of the pump assembly <NUM> are aligned with the keyway <NUM>, which extends through the lock <NUM>. Once the motor assembly <NUM> is in the unlocked position, the nozzle <NUM> can be compressed. Compression of the nozzle <NUM> causes the keys <NUM> on the shaft <NUM> of the pump assembly <NUM> to slide into the keyway <NUM> of the lock <NUM>, as shown in <FIG>. When the nozzle <NUM> is released, the keys <NUM> on the shaft <NUM> slide out from the keyway <NUM> and the internal gear wheel <NUM> may be rotated back to the locked position shown in <FIG>.

Turning now to <FIG>, there are shown various perspective views of the first portion <NUM> and second portion <NUM> of an embodiment of the housing <NUM> with a motor assembly <NUM>. In the depicted embodiment, the first portion <NUM> of the housing <NUM> contains the pump assembly <NUM>, the printed circuit board <NUM>, and the battery <NUM> (not shown), and the second portion <NUM> of the housing <NUM> contains the liquid container <NUM> (not shown). Referring first to <FIG>, there is a side view of the first portion <NUM> of the housing <NUM> and the second portion <NUM> of the housing <NUM> in an unlocked position. The first portion <NUM> of the housing <NUM> has apertures <NUM> along the outer circumference of its bottom surface <NUM>. A disc <NUM> stacked on top of the bottom surface <NUM> of the first portion <NUM> of the housing <NUM> has cutouts <NUM> along the outer circumference of the disc <NUM>. The cutouts <NUM> which are configured to align with the apertures <NUM> in the bottom surface <NUM> of the first portion <NUM>. Still referring to <FIG>, the motor <NUM> of the motor assembly <NUM> comprises a second gear <NUM> on a side of the motor <NUM> opposite the first gear <NUM>. The second gear <NUM> is used to rotate the disc <NUM> on the bottom surface <NUM> of the first portion <NUM>.

Referring now to <FIG>, the second portion <NUM> of the housing <NUM> comprises a plurality of L-shaped flanges <NUM> extending from the top surface <NUM> of the second portion <NUM>. The L-shaped flanges <NUM> are configured to fit through the apertures <NUM> in the bottom surface <NUM> of the first portion <NUM> and the cutouts <NUM> in the disc <NUM>. In the unlocked position, shown in <FIG>, the L-shaped flanges <NUM> are aligned with the apertures <NUM> in the bottom surface <NUM> of the first portion <NUM> and the cutouts <NUM> in the disc <NUM>. Therefore, the second portion <NUM> can be pulled and removed from the first portion <NUM> of the housing <NUM>.

To reach the locked position shown in <FIG>, the motor <NUM>, upon receiving an electrical signal from the printed circuit board <NUM>, rotates the second gear <NUM>, which rotates the disc <NUM>. The disc <NUM> rotates such that the cutouts <NUM> are no longer aligned with the L-shaped flanges <NUM>. Therefore, the L-shaped flanges <NUM> and consequently, the second portion <NUM> of the housing <NUM>, cannot be removed from the first portion <NUM>. In some embodiments, the disc <NUM> is spring loaded such that the locked position is the default position of the disc <NUM>.

The circuitry described to activate the locking mechanism may also be connected to one or more signal LEDs <NUM> on the housing <NUM>, as shown in <FIG>. In one embodiment, the signal LEDs <NUM> illuminate when the solenoid <NUM> is activated and the dispensing device <NUM> is in the locked position. In an alternative embodiment, the signal LEDs <NUM> may illuminate with color, such as red, when the solenoid <NUM> is activated and the dispensing device <NUM> is in the locked position, and green when the solenoid <NUM> is deactivated or otherwise inactive and the dispensing device <NUM> is in the unlocked position.

The circuitry also connects to and powers the screen <NUM> within the recess <NUM> on the housing <NUM>. In the embodiments shown in <FIG> and <FIG>, the recess <NUM> is enclosed by a lens <NUM>. The lens <NUM> protects the screen <NUM> from liquid, debris, and other contaminants while still allowing a user to view the screen <NUM> clearly. In the depicted embodiment, the lens <NUM> is flush with the housing <NUM> to allow the user to easily manipulate the dispensing device <NUM>. In one embodiment, the lens <NUM> may comprise a biometric sensor therein. In alternative embodiments, such as that shown in <FIG>, the biometric sensor <NUM> is at a separate location along the housing <NUM>. The biometric sensor <NUM> may include a fingerprint scanner, an iris scanner, a heart rate detector, and the like. The lens <NUM> may also comprise touchscreen capabilities such that the user may enter a passcode on a keypad displayed on the screen <NUM>. The biometric sensor <NUM> and passcode elements provide an additional layer of security for access to the medication verifying the individual using the device and sending a signal to the printed circuit board <NUM> to move the solenoid <NUM> into the unlocked position.

In some embodiments, the dispensing device <NUM> may further comprise a photocell <NUM> located within the housing and connected to the circuity. The photocell <NUM> detects light conditions inside the device. Thus, the photocell <NUM> can detect when the dispensing device <NUM> is tampered with or broken into. In other embodiments, the dispensing device <NUM> may further comprise a medication sensor <NUM> connected to the circuitry that monitors the level of medication in the liquid container <NUM>. Thus, the medication sensor <NUM> can send a signal to the printed circuit board <NUM> when the liquid container <NUM> is empty or has a low volume of medication remaining.

The pump assembly <NUM> may additionally comprise a tactile switch <NUM>. The tactile switch <NUM> operates as a momentary switch that it is activated when the pump assembly <NUM> is fully actuated. The tactile switch <NUM> is operably connected to the printed circuit board <NUM> where full actuations of the pump assembly <NUM> are recorded. Circuity from the printed circuit board <NUM> additionally extends to a real-time clock chip <NUM>. The real-time clock chip <NUM> can be used to provide the date and time for display on the screen <NUM>. As will be discussed later, the real-time clock chip <NUM> can also be used in conjunction with the solenoid <NUM> and tactile switch <NUM> to lock the dispensing device <NUM>.

Referring now to <FIG>, there are shown diagram representations of an embodiment of the method according to the present technology. In use, the components in the dispensing device <NUM> can communicate with a web platform accessible on the computing device <NUM> to control the dispensing of medication. The printed circuit board <NUM> may utilize Bluetooth low energy (BLE) as a wireless protocol to communicate with the computing device <NUM>. Thus, the printed circuit board <NUM> can be programmed from the computing device <NUM>. For example, a healthcare provider may adjust setting on the web platform via a terminal on a computing device <NUM>. The healthcare provider may indicate a dosage number for the medication stored in the liquid container <NUM> and a minimum time period between dosages. This information is then transmitted to the printed circuit board <NUM>. The printed circuit board <NUM> calculates the dosage number based on feedback from the tactile switch <NUM> and determines the time period between dosages based on data from the real-time clock chip <NUM>.

In addition to programming the dispensing device <NUM>, the web platform may be utilized by the healthcare provider to view status information from the dispensing device <NUM>. For example, the dosage time, lock status, tamper alerts, and dosages remaining are information that may be pushed via a wireless network and/or cellular data from the dispensing device <NUM> to the web platform, which is ultimately accessible by the healthcare provider at a terminal on the computing device <NUM>. In addition, the web platform may also include a calendar interface, or other scheduling format, for tracking patient dosages and prescription regimens. Thus, the dispensing device <NUM>, the healthcare provider's computing device <NUM>, and a patient's smartphone (as explained below) may exchange status information via GSM or some other similar digital cellular network.

The biometric sensor <NUM> may be programmed by the patient in the presence of the healthcare provider. For example, the healthcare provider can adjust settings on the web platform to allow for programming of the biometric sensor <NUM>. The biometric sensor <NUM> can then scan the fingerprint of the patient, for example, to assign the patient identity to the particular dispensing device <NUM>. Once programmed, the biometric sensor <NUM> will require identity verification before the dispensing device <NUM> can be used.

Once the dispensing device <NUM> is programmed via the web platform on the healthcare provider's computing device <NUM>, the patient may use the dispensing device <NUM>. To access the medication, the patient will first prove his or her identity by actuating the biometric sensor <NUM>, such as placing a finger on the biometric sensor <NUM> for fingerprint scanning verification. Once the patient's identity is verified, the patient can self-administer the first dose of medication.

In an alternative embodiment, the patient's smartphone or other computing device may serve as a second layer of authentication to utilize the dispensing device <NUM>. For example, the patient may have access to a patient interface of the web platform on his or her smartphone. At the dosing time, the patient may be required to authenticate himself or herself via the smartphone. For example, the patient may complete authentication by unlocking his or her phone via a passcode or fingerprint sensor. In another embodiment, the healthcare provider may send a temporary or one-use PIN code from the healthcare provider interface of the web platform to the patient interface of the web platform. Therefore, the patient can access the web platform on his or her smartphone, retrieve the PIN code, and enter the PIN code on the dispensing device <NUM> to unlock it.

To administer the first dose, the patient holds the dispensing device <NUM> such that the nozzle <NUM> is close to or partially within the nostril and applies pressure to the nozzle <NUM> towards the surface 104a of the first closed end <NUM>. The pump assembly <NUM> expels medication from the nozzle <NUM> such that the patient may inhale the medication. When the pump assembly <NUM> is actuated, the tactile switch <NUM> is also triggered. The tactile switch <NUM> sends a signal to the printed circuit board <NUM> that the pump assembly <NUM> has been actuated, indicating that a dosage has been administered. Simultaneously, the printed circuit board <NUM> associates the signal from the tactile switch <NUM> with the time provided by the real-time clock chip <NUM>.

If the healthcare provider has set a minimum time periodbetween dosages, receipt of the signal from the tactile switch <NUM> will also cause the printed circuit board <NUM> to actuate the solenoid <NUM>. The solenoid <NUM> will move into the path of the nozzle <NUM> thereby preventing the patient from administering a subsequent dose of medication. The dispensing device <NUM> will remain in the locked position with the solenoid <NUM> blocking the actuation of the nozzle <NUM> until the minimum time period has elapsed. The printed circuit board <NUM> can monitor the time using data received from the real-time clock chip <NUM>. Once the minimum time period has elapsed after actuation of the tactile switch <NUM>, the printed circuit board <NUM> will trigger the solenoid <NUM> to retract thereby allowing the patient to fully depress the nozzle <NUM> to administer a subsequent dosage. Thereafter, the locking process is repeated.

In embodiments wherein one or more signal LEDs <NUM> are located on the housing <NUM>, the signal LEDs may illuminate a red color when the solenoid <NUM> is in the path of the nozzle <NUM>, indicating that a dosage may not be administered, and a green color when the solenoid <NUM> is retracted, signaling to the patient that a subsequent dosage is available. As the printed circuit board <NUM> can wirelessly communicate with a computing device <NUM>, a signal from the printed circuit board <NUM> can be transmitted to the computing device <NUM> alerting the patient that the next dosage is available. In an alternative embodiment, the medication sensor <NUM> may transmit a signal to the printed circuit board <NUM> and ultimately to the computing device <NUM> indicating that the liquid container <NUM> is empty or has a low volume of medication remaining. This alerts the patient to initiate the process of refilling the prescription.

In embodiments wherein the housing <NUM> comprises a photocell <NUM>, the photocell <NUM> can be configured to send a signal to the printed circuit board <NUM> when the photocell <NUM> detects light above a programmed threshold. The printed circuit board <NUM> can be programmed to transmit a signal to a computing device <NUM> accessible by the healthcare provider. The signal can manifest as an alert on the web platform notifying the healthcare provider that thedispensing device <NUM> has been tampered with. In additional embodiments, the printed circuit board <NUM> may be programmed to send data from any component or combination of components of the dispensing device <NUM> to a computing device <NUM> operated by the healthcare provider and/or by the patient. The healthcare provider and the patient can then access this data to improve compliance with the treatment plan.

<FIG> and also <FIG>, <FIG> respectively illustrate two additional embodiments of the dispensing device <NUM>, <NUM> according to the invention. Components and/or design strategies of the various dispensing device embodiments <NUM>, <NUM>, <NUM> are combinable or exchangeable as understood by a person skilled in the pertinent art according to the teachings of the present disclosure. For instance, although not explicitly illustrated, the additional embodiments <NUM>, <NUM> can include the signal LEDs <NUM>, lens <NUM>, screen <NUM>, photocell <NUM>, medication sensor <NUM>, tactile switch <NUM>, real time clock <NUM>, any combination thereof, or variations thereof. Likewise, the additional embodiments <NUM>, <NUM> can include appropriate electrical circuitry and mechanical structures to support such components.

One of the embodiments <NUM> as illustrated includes sensors <NUM>, <NUM>, <NUM> (<FIG>) and visual features <NUM>, <NUM>, <NUM> (<FIG>) for detection of a level of depression of the nozzle <NUM>. Such sensors and visual features can be incorporated into other dispensing device embodiments <NUM>, <NUM> illustrated herein, or a variation thereof, as understood by a person skilled in the pertinent art according to the teachings of the present disclosure. The dispensing device <NUM>, <NUM>, <NUM> can be configured to lock the nozzle <NUM>, <NUM>, <NUM> when the nozzle is partially depressed for a prolonged period of time, and/or when a user performs a partial depression and returns the nozzle to a fully extended position. This prevents the user from administering multiple partial doses in an attempt to bypass the security of the dispensing device <NUM>, <NUM>, <NUM>.

The dispensing device <NUM>, <NUM>, <NUM> can further including a ratcheting dose lock such as dose lock <NUM> illustrated in <FIG> and dose lock <NUM> illustrated in <FIG>. The illustrated dose locks <NUM>, <NUM> are ratcheted to allow the nozzle <NUM>, <NUM> to return to the completely extended position and inhibit the nozzle from being further depressed when the dose lock <NUM>, <NUM> is in the locked position and the nozzle is partially depressed. Alternatively, the ratchet can be shaped to allow the nozzle to be depressed and inhibit extension of the nozzle. Each design has certain advantages. For instance, the lock-out ratchet (which inhibits depression of the nozzle) prevents further administration of the medication immediately when the lock is engaged, which may be a desired functionality if prevention of administering too much medication is of primary concern. The dose-forcing ratchet (which inhibits extension of the nozzle) prevents a partial depression from occurring when the lock is engaged, but may not prevent completion of a dose, which may be desired functionality if prevention of small doses is of primary concern.

The additional embodiments <NUM>, <NUM> can function together with one or more computing devices such as the computing device <NUM> illustrated in <FIG>, other computing devices disclosed herein, and/or one or more computing devices as understood by a person skilled in the pertinent art according to the teachings of the present disclosure. The dispensing devices <NUM>, <NUM> can be used to execute methods illustrated in <FIG>. The dispensing devices <NUM>, <NUM> can connect directly and/or remotely to a computing device (e.g. the illustrated computing device <NUM>) via Wi-Fi/, Bluetooth, cellular, and the like to control the dispensing device <NUM>, <NUM> (lock/unlock, load biometrics/load new nasal spray device/change dosing schedule). The dispensing devices <NUM>, <NUM> can communicate to the computing device <NUM> to alert a physician via push notifications if patient has missed a dose or tampering with device. The dispensing device <NUM>, <NUM> can be configured (e.g. by a physician) to generate an output to remind the patient when to dose. The output can be many different outputs known in the art, including, but not limited to a light, display, sound, or other alert or communication to another device such a patient's mobile phone. The dispensing devices <NUM>, <NUM> can further monitor patient usage of the dispensing device <NUM>, <NUM> and provide information/data related to the patient usage to a computing device <NUM>, directly via a display on the device <NUM>, <NUM>, or other means to inform the physician regarding patient adherence to prescription. The dispensing device <NUM>, <NUM> can have a timed lockout (preset by Dr), and/or scheduled lockout. The timed lockout can be preset by an authorized user (e.g. physician). The scheduled lockout can be set and/or edited remotely via a web platform (or other networked platform) accessible via a physician's computing device.

Both options still require patient credentials to unlock the device. This can be done using the biometric scanner on the device, or in future using the biometric(finger/facial/eye) scanning ability on the user's mobile phone.

Generally, the dispensing devices <NUM>, <NUM> provide secure drug delivery and include a disposable part containing the drug and a reusable exoskeleton or housing component. The exoskeleton secures the disposable part containing the drug/medicine and controls when and how the substance is dispensed. In some embodiments, the exoskeleton is able to secure (e.g. encapsulate) standardized nasal spray devices <NUM>. The exoskeleton can lock and unlock the nozzle movement of the standardized nasal spray <NUM>. The locking and unlocking of the device <NUM>, <NUM> (dosing) can be controlled and/or configured remotely (Wi-Fi/BT) via a mobile phone app and web platform, as prescribed by a Doctor/Physician. The nozzle can include lock details that interface with the exoskeleton lock mechanisms.

A standardized nasal spray device / vial <NUM> can be inserted into the exoskeleton from locations, including, but not limited to the top (see the dispensing device <NUM> illustrated in <FIG>) and bottom (see the dispensing device <NUM> illustrated in <FIG>, <FIG>). The top loading dispensing device <NUM> can include a nozzle <NUM> that is separable from the housing <NUM>. The nozzle <NUM> can be disposable and can be attached to the standardized nasal spray. Alternatively, a custom disposable vial can be constructed including a nozzle portion following the design strategies of the disposable nozzle <NUM>. Because the nozzle <NUM> of the top-loading dispensing device <NUM> is disposable, the nozzle <NUM> can be disposed and/or cleaned separately from the reusable housing <NUM> of the device <NUM>, thereby potentially provider better hygiene compared to the bottom-loading dispensing device <NUM>. The bottom-loading device <NUM> can be configured to receive a standard vial <NUM> without requiring a specialized nozzle <NUM>, and therefore can potentially provide convenience and/or cost savings over the top-loading device <NUM>.

The dispensing devices <NUM>, <NUM> can include sensors (e.g. optical/imaging) to detect nozzle movement and device tampering, micro movement sensors to detect user specific movement patterns to detect when a different user handles the device <NUM>, <NUM>, and/or a drug neutralizer (e.g. powder or sponge) to chemically neutralize drugs released from the internal vial <NUM>. As discussed above and as those skilled in the pertinent art would appreciate, one or more of these features can also be combined and/or interchanged with features of device <NUM>.

Specifics of each additional embodiment <NUM>, <NUM> will now be discussed in relation to the figures.

<FIG> is a profile view a top-loading dispensing device <NUM> according to the present invention. The dispensing device <NUM> includes a housing <NUM> and a nozzle <NUM> that together form an exoskeleton surrounding (at least partially) and securing a vial <NUM> (<FIG>).

The nozzle <NUM> and vial <NUM> illustrated in <FIG> are snapped together. The nozzle <NUM> includes a housing interface <NUM> that snaps onto the vial <NUM>, allowing the nozzle <NUM> to be depressed, and providing features thereon for locking the combined nozzle <NUM> and vial <NUM> into the housing <NUM>. The combined nozzle <NUM> and vial <NUM>, whether mated during or post-production, can function to deliver medication both with and without the housing <NUM>, which allows health care providers to choose whether a specific patient, when given a particular medication, is provided the medication in the housing <NUM> or not. Because the nozzle <NUM> is not integral to the housing <NUM>, the nozzle <NUM> can be disposed of, or cleaned separately from the housing <NUM>, thereby potentially providing a more hygienic product compared a reusable dispensing device with an integral nozzle. Further, the opening <NUM> through which the nozzle <NUM> slides during operation is the same opening from which the vial is removed, eliminating the need for a second opening for vial removal. Without a second opening for vial removal, the cover <NUM> of the housing <NUM> can have a smoother, and therefore potentially more tamper resistant outer surface.

The device <NUM> is oriented vertically about a longitudinal axis L-L intersected by orthogonal planes A, B. The housing <NUM> has a first, top end <NUM> with a first, top surface 404a orthogonal to the longitudinal axis L-L and planes A, B. The housing <NUM> has a second, bottom end <NUM> with a second, bottom surface 406b substantially parallel to the first surface 404a. The nozzle <NUM> extends perpendicular from the top surface 404a of the housing <NUM>. The housing <NUM> has an opening <NUM> on the top surface 404a, and the nozzle <NUM> has a housing interface <NUM> configured to be positioned within the opening <NUM> and slidably engage the housing <NUM>. When the nozzle <NUM> is slidably engaged to the housing <NUM> as illustrated, and the nozzle <NUM> is unlocked, the nozzle <NUM> is translatable from a completely extended position as illustrated in <FIG> to a completely depressed position where a bottom surface <NUM> of an engagement ring <NUM> of the nozzle <NUM> approaches the top surface 404a of the housing <NUM> similar to the depressed position of nozzle <NUM> in relation to housing surface 104a as illustrated in <FIG>.

As used herein, the terms "completely extended position" and "completely depressed position" refer to the extremes between which the nozzle moves for its intended purpose of providing a dosage.

The housing <NUM> can further include a biometric sensor <NUM> which can function similar to the biometric sensor <NUM> described elsewhere herein. For instance, a fingerprint scan on the sensor <NUM> can be used by electrical circuitry of the device <NUM> to determine whether to unlock the dose lock. Additionally, or alternatively, a fingerprint scan on the sensor (e.g. by a physician) can be used by electrical circuitry of the device <NUM> to determine whether to unlock the vial. The housing <NUM> can include a finger cover <NUM>. The finger cover <NUM> can include a display, and/or a display can be positioned elsewhere on the housing <NUM>.

The display can function similar to the display <NUM> described elsewhere herein.

The device <NUM> can further include a removable nozzle cap <NUM>.

<FIG> is a profile view, in the same orientation as <FIG>, of the nozzle <NUM> engaged to a medicinal vial <NUM>. Referring collectively to <FIG>, the nozzle <NUM> and vial <NUM> as assembled in <FIG> are removable from the housing <NUM> in <FIG> without damaging the housing <NUM>, and preferably without damaging the nozzle <NUM>. During usage, the nozzle <NUM> and vial <NUM> are replaceable and preferably disposable. The housing <NUM> can be reloaded with a new nozzle <NUM> and vial <NUM> assembly. The medicinal vial <NUM> can be loaded via the opening <NUM> in the top surface 404a of the housing <NUM>. The housing <NUM> therefore includes a chamber <NUM> (<FIG>) sized to receive the medicinal vial <NUM>, and the chamber <NUM> is accessible via the opening <NUM> in the top surface 404a of the housing <NUM>.

The outer surface of the housing <NUM>, when assembled to the nozzle <NUM> can be completely devoid of fasteners or other externally accessible avenues for opening the device <NUM>. In some applications it can be desirable to provide draining holes <NUM> to allow liquids which have been released from the vial <NUM> in the device <NUM> to exit the device <NUM>. In other applications, it can be desirable to capture liquids released from the vial <NUM> within the device <NUM> (e.g. a sponge in the chamber <NUM> illustrated in <FIG> and <FIG>).

<FIG> are orthogonal profile views of the nozzle <NUM> and vial <NUM> where <FIG> is looking onto the left side of the assembly illustrated in <FIG> and <FIG> is looking onto the right side of the assembly illustrated in <FIG>. <FIG> is an illustration of the assembly illustrated in <FIG>, <FIG> with the nozzle <NUM> removed. Referring collectively to <FIG>, <FIG> the nozzle <NUM> includes a conical portion <NUM>, an engagement ring <NUM>, and a housing interface <NUM>, a spring <NUM>, and a retention ring <NUM>. Preferably, the conical portion <NUM>, engagement ring <NUM>, and housing interface <NUM> are molded as a single piece, handle portion <NUM>. Alternatively, at least one of the conical portion <NUM>, engagement ring <NUM>, and housing interface <NUM> can be individually molded and affixed together to form the handle portion <NUM>.

The conical portion <NUM> has a dispensing end <NUM>, a base end <NUM>, and a fluidic passageway <NUM> extending along the longitudinal axis L-L through the base end <NUM> and dispensing end <NUM>. The engagement ring <NUM> extends radially from the base end <NUM> of the conical portion to provide a top surface <NUM> against which a user can provide a force to depress the nozzle <NUM>. A bottom surface <NUM> of the engagement ring <NUM> faces away from the dispensing end <NUM>. The bottom surface <NUM> can further be shaped or otherwise configured to contact the top surface 404a of the housing <NUM>, when the device <NUM> is assembled, to inhibit further depression of the housing interface <NUM> into the housing <NUM>. The housing interface <NUM> has an outer surface <NUM> that circumscribes the longitudinal axis L-L, an upper end <NUM> affixed to the engagement ring <NUM>, an open lower end <NUM>, a passageway <NUM> extending between the upper end <NUM> and lower end <NUM>. A vial <NUM> and nozzle <NUM> assembled during production, because it is pre-assembled, does not require any further assembly on the part of the health care provider, and therefore provides greater convenience.

The nozzle <NUM> can be fitted to the vial <NUM> by first placing the retention ring <NUM> and spring <NUM> over the vial <NUM> and then sliding the housing interface <NUM> over the spring and retention ring <NUM>. The housing interface <NUM> can include flexible hooks <NUM> that extend to move over the vial <NUM> and snap under a ridge on the vial to engage and secure the nozzle <NUM> to the vial <NUM>. The interior of the conical portion <NUM> and engagement ring <NUM> can be shaped to fit over the vial nozzle. The vial and nozzle assembly can further include an adapter or vial nozzle cover to aid in mating the nozzle <NUM> to the vial <NUM>. In this way, the nozzle <NUM> can be fit over existing standard sized vials. Alternatively, the vial <NUM> and nozzle <NUM> can be specially designed in concert and/or integrated.

The nozzle <NUM> includes features that function together with the housing <NUM> to control dispensing of a drug in the vial <NUM> as described in greater detail below. As illustrated in <FIG>, <FIG>, the drug can also be dispensed when the nozzle <NUM> and vial assembly are outside of the housing. This can allow drugs, whether they are intended to be regulated during usage or not, to be packaged identically, adding convenience, and potentially saving cost.

Referring to <FIG>, the housing interface includes openings <NUM>, <NUM>, <NUM> in the outer surface <NUM> to aid in detecting partial depression of the nozzle <NUM>. As the nozzle <NUM> is depressed over the vial <NUM>, movement of the housing interface <NUM> in relation to a portion of the nozzle <NUM>, such as the retention ring <NUM>, is visible through the openings <NUM>, <NUM>, <NUM>. The housing <NUM> can include one or more sensors to detect movement of the portion of the nozzle <NUM> (e.g. retention ring <NUM>) over the openings <NUM>, <NUM>, <NUM>. <FIG> illustrates three openings <NUM>, <NUM>, <NUM> positioned such that three positions of depression of the nozzle <NUM> are detectable. The housing interface <NUM> can include one or more such openings <NUM>, <NUM>, <NUM> to serve the same purpose, where the maximum number of openings is limited by physical design constraints as understood by a person skilled in the pertinent art according to teachings of the present disclosure. Preferably, the outer surface <NUM> of the housing interface <NUM> is visually in high contrast with the retention ring <NUM> so that the retention ring <NUM> can be easily visualized in relation to the housing interface <NUM> by optical sensors. When the nozzle <NUM> and vial <NUM> assembly is installed in the housing <NUM>, the retention ring <NUM> is substantially stationary in relation to the optical sensors while the openings <NUM>, <NUM>, <NUM> move to cover and uncover the optical sensors' view of the retention ring <NUM>. Optical sensors check for movement at the start of the dose and at the end of a dose by detecting movement of the top and bottom openings <NUM>, <NUM> on the housing interface <NUM>. If a dose is started but not pushed all the way to the bottom the dose lock <NUM> will engage (described in greater detail in relation to <FIG> and <FIG>).

As illustrated in <FIG> and <FIG>, the housing interface <NUM> includes indentations <NUM> for locking depression of the nozzle <NUM> into the housing <NUM>, i.e. inhibiting a user from receiving a dose. Two indentations <NUM> are illustrated. The lower indentation is positioned to maintain the nozzle at a completely extended position when the housing interface <NUM> is slidably engaged to the housing <NUM>.

<FIG> and <FIG> illustrate the housing dose lock <NUM> which engages the indentations <NUM> on the nozzle <NUM>.

Referring collectively to <FIG>, <FIG>, <FIG>, and <FIG>, during intended usage of the device <NUM>, a user allows the nozzle to return to the completely extended position following each application of the medicine, and after an application is completed, the nozzle <NUM> locks in the completely extended position by engaging the lower indentation with dose lock <NUM>. A user may, however, inadvertently, or intentionally partially depress the nozzle at the same time that a dose lock <NUM> (see <FIG> and <FIG>) of the housing <NUM> is engaged. In this case, the upper indentation is positioned to engage the dose lock <NUM> and inhibit the nozzle from further depression when the nozzle is partially depressed. At least the upper indentation can have an angled shape such that although the nozzle <NUM> is inhibited from further depression, the vial lock can slide downward out of the indentation <NUM> to allow the nozzle <NUM> to extend further from the housing <NUM>. In usage, if the upper indentation is engaged by the vial lock at the time that the nozzle <NUM> is locked, when depression force is removed from the nozzle <NUM>, the spring <NUM> pushes the nozzle <NUM> out of the housing <NUM> toward the completely extended position. The dose lock <NUM> can thereby slide from the upper indentation to the lower indentation. Although one upper indentation is shown, the housing <NUM> can further include additional angled indentations positioned to engage the vial lock when the nozzle <NUM> is depressed at multiple partial depression positions. The angled notches can thereby function as a ratchet, allowing one way movement of the nozzle <NUM> when the vial lock is engaged. Number and position of the angled notches can be determined by physical design constraints as understood by a person skilled in the pertinent art.

Ratcheting action of the dose lock <NUM> can thereby lock out a user who attempts to subvert the dose lock <NUM> when the user applies a dosage (by depressing the nozzle <NUM>), then slowly releases the nozzle <NUM> toward the extended position, stopping just short of reaching the completely extended position and engaging the lower indentation <NUM> (see also <FIG>), and then attempts to again depress the nozzle <NUM>.

Referring to <FIG>, the housing interface <NUM> can further include a vial lock opening <NUM>. The vial lock opening <NUM> can be shaped, sized, and otherwise configured to engage a vial lock <NUM> (see <FIG> and <FIG>) of the housing <NUM>. When the vial lock is extended into the opening <NUM>, the engagement of the vial lock to a lower ledge <NUM> of the opening <NUM> can inhibit the nozzle from being pulled out of the housing <NUM>. The opening <NUM> can be sized so that the vial lock travels freely through the opening <NUM> when the nozzle <NUM> is depressed to deliver medication. The opening can further be sized such that the vial lock engages an upper ledge <NUM> of the opening <NUM> to set the completely extended position of the nozzle <NUM>. Alternatively, the completely extended position of the nozzle <NUM> can be set and/or aided through engagement of additional features on the housing <NUM> and housing interface <NUM> as understood by a person skilled in the pertinent art according to the teachings of the present disclosure.

<FIG> is a cross sectional view of the device <NUM> oriented as illustrated in <FIG> and cut along plane B. Several of the components of the housing <NUM> are removed to highlight the dose lock <NUM> and vial lock <NUM>. Additional components of the housing <NUM> (including a chassis <NUM>) are illustrated in <FIG> and <FIG>.

Each of the locks <NUM>, <NUM> respectively includes a motor <NUM>, <NUM>, a cam <NUM>, <NUM>, and a sliding extension <NUM>, <NUM>. When the nozzle <NUM> is at the completely extended position as illustrated, the sliding extension <NUM> of the dose lock is engaged to the lower indentation <NUM> on the housing interface <NUM> and the sliding extension <NUM> of the vial lock is engaged to the lower ledge <NUM> of the vial lock opening <NUM> of the housing interface <NUM>.

When the dose lock <NUM> and vial lock <NUM> are both locked and the nozzle is in the completely extended position, the dose lock <NUM> prevents depression of the nozzle <NUM> and teh vial lock prevents extension of the nozzle <NUM>. When the dose lock <NUM> is open, the vial lock <NUM> provides a stop to set the completely depressed position of the nozzle <NUM>.

The lower ledge <NUM> of the vial lock opening <NUM> and a bottom, mating surface of the sliding extension <NUM> of the vial lock <NUM> are each angled downward and inward. When in this position, the vial lock <NUM> is inhibited from disengaging the housing interface <NUM> while the dose lock <NUM> remains engaged to the lower indentation <NUM>. If a user were to attempt to pull the nozzle <NUM> out of the housing <NUM>, the sliding extension <NUM> can slide against the lower ledge <NUM>, extending further into the housing interface <NUM>, thereby further engaging the housing interface <NUM>.

To remove the nozzle <NUM> and vial <NUM>, an authorized user (e.g. physician or pharmacist) will send a command to the dispensing device <NUM> to remove the vial <NUM>. The dose lock <NUM> will disengage, the authorized user will push the nozzle <NUM> down to disengage the undercut on the housing interface <NUM>, a sensor (e.g. optical sensor viewing one or more openings <NUM>, <NUM>, <NUM>) will sense the nozzle <NUM> is depressed, and the vial lock <NUM> will unlock and the vial <NUM> can then be removed.

Opening of each lock <NUM>, <NUM> can include rotation of the respective motor <NUM>, <NUM> which causes the respective cam <NUM>, <NUM> to turn and the respective sliding extension <NUM>, <NUM> to slide outwardly, away from the housing interface <NUM>, thereby disengaging the housing interface <NUM>. Closing of each lock <NUM>, <NUM> can include reverse rotation of the respective motor <NUM>, <NUM> which causes the respective cam <NUM>, <NUM> to turn opposite from opening to release the respective sliding extension <NUM>, <NUM>, allowing springs <NUM>, <NUM> (<FIG>) to push the respective sliding extension <NUM>, <NUM> toward the housing interface <NUM>, thereby engaging the housing interface <NUM>.

The dose lock <NUM> can include an angled sliding extension <NUM> shaped to engage indentations <NUM> on the housing interface <NUM> of the nozzle <NUM>. The extension <NUM> of the dose lock <NUM> can ratchet across multiple indentations <NUM> (see <FIG>).

<FIG> and <FIG> are each a top down view of the housing <NUM>, orthogonal to planes A and B. <FIG> is a cross-sectional view of the housing <NUM> cut at plane C as indicated in <FIG>.

<FIG> illustrates the top surface 404a, opening <NUM>, chamber cavity <NUM>, sliding extension <NUM> of the dose lock <NUM>, and sliding extension <NUM> of the vial lock <NUM>. The vial lock <NUM> includes an upper and lower fin. The lower fin is shaped to engage the lower ledge <NUM> of the vial lock opening <NUM> of the housing interface <NUM> of the nozzle <NUM> as illustrated in <FIG>. The upper fin is shaped to engage the upper ledge <NUM> of the vial lock opening <NUM> to set the completely extended position of the nozzle <NUM>. The opening <NUM> includes a key extension <NUM>. The housing interface <NUM> is indented on the side illustrated in <FIG> for proper orientation of the nozzle <NUM> when the housing interface <NUM> is inserted into the opening <NUM>.

<FIG> illustrates additional component parts of the housing <NUM> and locks <NUM>, <NUM>. Each lock <NUM>, <NUM> includes respective springs <NUM>, <NUM> attached to the respective sliding extensions <NUM>, <NUM> to move the locks <NUM>, <NUM> to the closed position when the respective cams are positioned as illustrated. The cams <NUM>, <NUM> are positioned as mirror images of each other, and can alternatively be otherwise positioned as understood by a person skilled in the pertinent art according to the teachings of the present disclosure. To open the locks <NUM>, <NUM> the cam <NUM> of the dose lock <NUM> rotates clockwise and the cam <NUM> of the vial lock <NUM> rotates counterclockwise (i.e., in opposite directions due to mirror symmetry of cams <NUM>, <NUM>). As the respective cams <NUM>, <NUM> rotate, they engage a respective bump <NUM>, <NUM> on the respective sliding extension <NUM>, <NUM>, thereby pushing against the springs <NUM>, <NUM> and moving the sliding extension <NUM>, <NUM> outwardly to the open position. The bumps <NUM>, <NUM> are centered on the respective sliding extension <NUM>, <NUM> to minimize sideways movement of the extension <NUM>, <NUM>, thus reducing the risk of jamming the lock compared to a non-centered engagement. The bumps <NUM>, <NUM> and cams <NUM>, <NUM> are preferably configured such that the cams <NUM>, <NUM> have a small contact area and therefore lower friction compared to a larger contact area.

Another option is to have one or both cams <NUM>, <NUM> rotate past <NUM> degrees over the bump <NUM>, <NUM>. This option does not rely on the friction of a motor gearbox to keep the lock open <NUM>, <NUM> and thus allows for more options on motor selection.

Each lock <NUM>, <NUM> includes stops <NUM>, <NUM> against which a vertical extension <NUM>, <NUM> of the respective cam <NUM>, <NUM> presses when the cam has reached the end of its rotational travel. Each stop <NUM>, <NUM> is preferably integral to a chassis <NUM> (see also <FIG>) of the housing <NUM>, rather than to the respective sliding extension <NUM>, <NUM>. Stops <NUM>, <NUM> integral to the chassis <NUM> can reduce likelihood of rotation (and therefore jamming) of the respective sliding extension <NUM>, <NUM> when the respective cam <NUM>, <NUM> engages the respective stop <NUM>, <NUM> compared to stops integral to the sliding extensions <NUM>, <NUM>. The chassis <NUM> can also provide structural support for, or otherwise be engaged to the springs <NUM>, <NUM> and motors <NUM>, <NUM>.

Referring still to <FIG>, the housing <NUM> includes a printed circuit board <NUM> with electrical components connected thereto that together form electrical circuitry for performing various functions of the device <NUM>. The circuit board <NUM> can include a processor and non-transitory computer readable medium with instructions thereon that when executed by the processor cause the electrical circuitry to perform functions described herein, including functionality described in relation to the system illustrated in <FIG>. The circuit board <NUM> need not have the specific form as illustrated. The electrical circuitry of the housing <NUM> can include a ridged board, a flexible circuit, discrete components, free wiring, and/or combinations thereof, for instance. Several forms of electrical circuitry can be utilized to carry out the functions described herein as understood by a person skilled in the pertinent art according to the teachings of the present disclosure. The electrical circuitry of the device <NUM> can further include a medication sensor <NUM>, tactile switch <NUM>, and/or real-time clock as described elsewhere herein.

The electrical circuitry includes three optical sensors <NUM>, <NUM>, <NUM> mounted to the circuit board <NUM>. Each sensor <NUM>, <NUM>, <NUM> is positioned to view a respective opening <NUM>, <NUM>, <NUM> in the housing interface <NUM> of the nozzle <NUM>. Each sensor <NUM>, <NUM>, <NUM> is configured to provide a sensor signal indicative of a depressed position of the housing interface. At least the middle sensor <NUM> is positioned to provide a sensor signal indicative of a partially depressed position of the nozzle between the completely extended position and the completely depressed position. Monitoring partial depression of the nozzle <NUM> can be useful to determining proper administration of the medication and/or for tamper prevention. In some embodiments, the electrical circuitry can be configured to close the dose lock <NUM> in response to receiving a sensor signal from the middle sensor indicative of a prolonged partially depressed position and/or a repeated partial depression of the nozzle <NUM>. In some embodiments, the processor is configured to receive the sensor signal and execute instructions in the memory to cause the electrical circuitry to activate the motor <NUM>, thereby turning the cam <NUM> and closing the lock <NUM>.

The device <NUM> can include additional or alternative sensors and/or indicators for detecting partial depression of the nozzle <NUM>. As one example, the housing interface <NUM> can include a high contrast image in place of the openings such as a series of horizonal lines across the outer surface <NUM> of the housing interface <NUM>. As the nozzle <NUM> is depressed, the electrical circuitry can determine the number of lines which have passed in front of one or more optical sensors <NUM>, <NUM>, <NUM> based on signals from the sensor(s). Additionally, or alternatively, the horizontal lines can vary in thickness, to thereby create a distinct sensor signal depending on which line is viewed by the optical sensor. As another example, the housing interface <NUM> can include a conductive strip, and circuit board <NUM> can include two or more contacts positioned to simultaneously come into electrical contact with the conductive strip when the nozzle <NUM> is partially depressed. Electrical circuitry of the housing <NUM> can detect when the contacts are shorted to thereby detect partial depression of the nozzle <NUM> at one or more partial depression positions.

The top and bottom openings <NUM>, <NUM> can be used to determine when the nozzle <NUM> is in the completely extended positioned or completely depressed position. Alternatively, the housing <NUM> can include limit switches to detect when the nozzle <NUM> is in the completely extended and/or completely depressed position.

Engagement of the cam <NUM>, <NUM> to the stops <NUM>, <NUM> can be detected by monitoring current to the respective motor <NUM>, <NUM>. When the electrical circuitry detects an increase in current over a predetermined threshold (e.g. as provided by the instructions in the memory), the electrical circuitry can reduce or remove power to the motor <NUM>, <NUM>.

The electrical circuitry can further include a sensor (e.g. optical sensor) for detection of a vial <NUM>.

The electrical circuitry can be powered by a battery <NUM> integrated into the housing <NUM>. The electrical circuitry can include battery charging regulation and battery protection circuitry (e.g. over-voltage, under-voltage, over-current, etc.).

The electrical circuitry can be configured to hold the dose lock <NUM> for the set amount of doses (e.g. as entered by a physician or pharmacist), then returns the dose lock <NUM> to closed/lock position. When returned to closed/lock position the springs <NUM> push the dose lock extension <NUM> to engage the housing interface <NUM>.

<FIG> is an illustration of an exploded view of component parts of the device <NUM> and vial <NUM>. The nozzle <NUM> includes the handle portion <NUM>, spring <NUM>, and retention ring <NUM>. The vial <NUM> includes a liquid container <NUM>, an atomizer <NUM>, and a vial nozzle <NUM>. The housing <NUM> includes a top cover <NUM>, a light guide <NUM>, and a top ring <NUM> which together form the top surface 404a of the housing <NUM>. The housing <NUM> further includes a light emitting diode (LED) board <NUM> including LEDs positioned to illuminate the light guide <NUM>. The same or additional LEDs can provide illumination for optical sensors in the housing <NUM>. Components parts of the dose lock <NUM> and vial lock <NUM> are secured to the chassis <NUM> by a respective lock cover <NUM>, <NUM>. The circuit board <NUM> includes a scan nest <NUM> mounted thereon to which the biometric sensor <NUM> can be mounted. The lock covers <NUM>, <NUM> and circuit board <NUM> are affixed to the chassis by screws <NUM>. Of course, alternative fasteners, glues, snaps, or other strategies can be used to secure component parts to the chassis <NUM> and/or within the housing <NUM> as understood by a person skilled in the pertinent art according to the teachings of the present disclosure.

The housing <NUM> can be charged via inductive charging. The housing <NUM> includes an inductive coil <NUM> positioned near the bottom end <NUM> of the device <NUM>, inside of the cover <NUM>. The cover <NUM> can include a co-mold ring <NUM> near the bottom end <NUM> for added stability to inhibit the device <NUM> from overturning during charging. Electronic circuitry of the housing <NUM> can include circuitry for inductively charging the battery <NUM> with the coil <NUM> including circuitry designed according to currently available inductive chargers and other such wireless charging schemes yet to be developed. Incorporating wireless charging into the housing eliminates the need for a charging port, which eliminates a point of ingress for the user and therefore can provide a device that is more robust against tampering compared to a device with a wired charging port. Further, because the user does not have direct access to the charging mechanism, a device with wireless charging can be more resistant to damage (at least to the charging circuit) compared to a device with a wired charging port.

The entire assembly has no screws exposed with the cover <NUM> clipping over the chassis <NUM>. The function of parts, mechanical and electrical, can be assembled and tested on the chassis <NUM> before the cover <NUM> is clipped over.

<FIG> are illustrations of an alternative handle portion <NUM> of a nozzle of the dispensing device <NUM> illustrated in <FIG>. The handle portion <NUM> includes an upper portion 463a and a lower portion 463b that are manufactured as two separate parts. The upper portion 463a and 463b include clips <NUM> that can engage each other to secure the upper portion 463a to the lower portion 463b in a tamper resistant way, meaning the upper portion 463a and lower portion 463b are not easily separable by a recipient of the medication. The handle portion <NUM> can include a cradle <NUM> sized to house depression tabs <NUM> of a vial nozzle <NUM> (see <FIG>). The cradle <NUM> can be sized to house larger depression tabs <NUM> that may be found on many medicinal vials <NUM> presently used in the industry.

The nozzle <NUM> of the dispensing device <NUM> having a handle portion <NUM> as illustrated in <FIG> can be fitted to the vial <NUM> by removing the vial nozzle <NUM> from the vial <NUM>, placing the retention ring <NUM> and spring <NUM> over the vial <NUM>, sliding the housing interface <NUM> over the spring and retention ring <NUM>, placing the vial nozzle <NUM> onto the vial <NUM> such that the depression tabs <NUM> are positioned within the cradle <NUM> of the lower portion 463b of the handle portion <NUM>, and snapping the upper portion 463a of the handle portion <NUM> over the vial nozzle <NUM> and secured the lower portion 463b of the handle portion <NUM>. The sequence of affixing the nozzle <NUM> to the vial <NUM> can be carried out in a variety of ways, with steps performed in different order than listed as understood by a person skilled in the pertinent art; for instance, the vial nozzle <NUM>, spring, and/or retention ring <NUM> can be secured within the handle portion <NUM> before the vial <NUM> is inserted into the handle portion <NUM>. The housing interface <NUM> can include flexible hooks <NUM> that extend to move over the vial <NUM> and snap under a ridge on the vial to engage and secure the nozzle <NUM> to the vial <NUM>. Once the nozzle <NUM> of the dispensing device is attached to the vial <NUM>, the nozzle <NUM> can be inserted into the housing <NUM> and the dispensing device <NUM> can function as described in relation to <FIG>.

<FIG> illustrate one example geometry of a handle portion <NUM> having separate portions that can secure a vial nozzle <NUM> in a tamper proof fashion. Other alternatives including a handle portion <NUM> including two vertically divided portions and/or more than two separate portions can be constructed as understood by a person skilled in the pertinent art.

<FIG> is an illustration of an exploded view of another embodiment of the dispensing device <NUM> according to the present invention. <FIG> is an illustration of a cross-sectional view of the dispensing device in plane A as indicated in <FIG>. <FIG> is an illustration of a cross-sectional view of the dispensing device in plane B as indicated in <FIG>.

Distinctions between the dispensing device <NUM> illustrated in <FIG> and the device <NUM> illustrated in <FIG> include the vial <NUM> being loadable from the bottom of the device <NUM> and the nozzle being integral with (i.e. non-separable from without damaging or specialized disassembly) the housing. The dispensing device <NUM> illustrated in <FIG> can have electrical circuitry and components (e.g. mechanical and/or electrical components) to perform partial dosage detection, biometric scanning, wireless and/or wired communication to other computing devices, programmability for timed dosage, micro-movement detection, drug identification, medication quantity sensing, and other such functionality as described in relation to other dispensing device embodiments <NUM>, <NUM> described elsewhere herein.

Referring collectively to <FIG>, <FIG>, the dispensing device <NUM> includes a handle portion <NUM>, top cover <NUM>, LED board <NUM>, light guide <NUM>, top rim <NUM>, housing interface <NUM>, spring <NUM>, chassis <NUM>, battery <NUM>, biometric sensor <NUM>, sliding dose lock extension <NUM>, dose lock cam <NUM>, dose lock motor <NUM>, c-shaped vial lock extension <NUM>, vial lock cam <NUM>, vial lock motor <NUM>, circuit board <NUM>, cover <NUM>, finger cover <NUM>, cover co-mold <NUM>, and base <NUM>.

The top cover <NUM>, LED board <NUM>, light guide <NUM>, and top rim <NUM> assemble similar to the corresponding components <NUM>, <NUM>, <NUM>, <NUM> of the dispensing device <NUM> illustrated in <FIG>.

The nozzle of the device <NUM> includes the handle portion <NUM>, spring <NUM>, and housing interface <NUM>. The handle portion <NUM> includes a conical portion and engagement ring similar to the conical portion <NUM> and engagement ring <NUM> of the handle portion <NUM> of the nozzle <NUM> of the dispensing device <NUM> illustrated in <FIG>. The handle portion <NUM> and housing interface <NUM> clip to each other.

The housing interface <NUM> has an outer surface <NUM> which includes features thereon for detection of partial depression of the nozzle similar to features on the outer surface <NUM> of the housing interface <NUM> of the dispensing device <NUM> illustrated in <FIG>. Likewise, the electrical circuitry (i.e. circuit board <NUM> and other electrical components) of the device <NUM> include sensors for detecting position and/or movement of the features on the housing interface <NUM>.

The device <NUM> includes limit switches to detect when the nozzle of the device <NUM> is in the completely extended and/or completely depressed position. Additionally, or alternatively, the device <NUM> can include openings in the housing interface <NUM> similar to openings <NUM>, <NUM> of the device <NUM> illustrated in <FIG> to detect when the nozzle of the device <NUM> is in the completely extended and/or completely depressed position.

The housing interface <NUM> further includes indentations <NUM> positioned to engage the dose lock extension <NUM>. The indentations <NUM> can be angled to inhibit depression and allow extension of the nozzle when the handle <NUM> is partially depressed. The dose lock <NUM> (including dose lock extension <NUM>, cam <NUM>, and motor <NUM>) can ratchet across the indentations <NUM> similar to the functionality of the dose lock <NUM> and indentations <NUM> of the device <NUM> illustrated in <FIG>. The dose lock extension <NUM> includes an angled ledge <NUM> that fits within the angled indentations <NUM>. The dose lock extension <NUM> has a ring shape. The dose lock is pressed into the locked position by a spring <NUM>. The cam <NUM> and motor <NUM> of the dose lock are positioned on an opposite side (compared to the angled ledge <NUM>) of the ring of the dose lock extension <NUM>. To open the dose lock, the motor <NUM> activates to turn the cam <NUM> which presses against the dose lock extension <NUM>, against the force of the spring <NUM> to move the angled ledge <NUM> out of the indentations <NUM>.

The vial lock <NUM> includes the c-shaped vial lock extension <NUM>, vial lock cam <NUM>, and vial lock motor <NUM>. The general orientation of the vial lock <NUM> is upside down in comparison to the vial lock <NUM> of the device <NUM> illustrated in <FIG> to facilitate removal of the vial <NUM> via the bottom <NUM> of the device <NUM>. The base <NUM> fits into the chassis <NUM> and is held in place by engagement of the vial lock extension <NUM> to an indentation <NUM> on the base <NUM>. To open the vial lock <NUM>, the motor <NUM> is activated to rotate the cam <NUM>, where thereby disengages the vial lock extension <NUM> from the indentation <NUM> on the base <NUM>. The vial lock extension <NUM> is held in the locked position by a spring and is opened by activating the vial lock motor <NUM> to rotate the cam <NUM> to push the vial lock extension <NUM> against the spring. The base <NUM> can include multiple angled indentations to ratchet the base <NUM> into the device <NUM>. The ratchet can inhibit movement of the base <NUM> out of the device <NUM> and allow movement of the base <NUM> into the device <NUM>.

The vial lock <NUM> can alternatively include a ring gear lock that goes around the vial <NUM>. The alternative design can increase system reliability and/or reduce production cost. A motor turns the ring gear lock thereby disengaging the vial lock while the vial holder/ base <NUM> is in place. Once the vial <NUM> is not present the ring gear lock returns to the locked position. The base <NUM> can then be pushed back in to lock in place. Lock clips rely on the spring action of the plastic to move for the base to lock.

Position of the dose lock <NUM> and vial lock <NUM> are detected by measuring an increase in current when the respective cam <NUM>, <NUM> is turned by the respective motor <NUM>, <NUM> into a stop similar to as described in relation to the device <NUM> illustrated in <FIG>.

The device <NUM> further includes a sensor (e.g. limit switch or optical sensor) to detect presence of a vial <NUM>.

The entire assembly can have no screws exposed with the cover <NUM> clipping over the chassis <NUM>. Functionality of mechanical and electrical parts can be assembled and tested on the chassis <NUM> before the cover <NUM> is clipped over.

The device <NUM> includes a Mini USB port for charging. Alternatively, the device <NUM> can include a coil or inductive charging and/or an alternative charging port such as USB C, proprietary charging port, or other charging port as understood by a person skilled in the pertinent art according to the teachings of the present disclosure.

<FIG> illustrates a system diagram of an example system including a digital platform <NUM>, a user device <NUM>, and a dispensing device <NUM>. The digital platform <NUM> and user device <NUM> can each include the computing device <NUM> illustrated herein, an alternative thereto, and/or a variation thereof as appreciated and understood by a person a person skilled in the pertinent art according to the teachings of the present disclosure. The dispensing device <NUM> can include any one of the dispensing devices <NUM>, <NUM>, <NUM> illustrated herein, an alternative thereto, and/or a variation thereof as appreciated and understood by a person skilled in the pertinent art according to the teachings of the present disclosure.

An authorized user <NUM> (e.g. doctor) can receive information related to prescription adherence, nozzle position, vial type, patient information, device information, prescription information, dosage information, and dispensing device tampering via the digital platform <NUM>. The information can be provided as an output <NUM> of the dispensing device <NUM>. The authorized user <NUM> can input commands related to nozzle locking/unlocking, vial locking/unlocking, and/or biometrics loading/clearing via the digital platform <NUM>. The digital platform can communicate via an application on the user device <NUM> to the dispensing device <NUM>.

A user (e.g. patient) can be authenticated by the dispensing device <NUM> via the user device <NUM> and/or biometric scanner <NUM>. The user device <NUM> can further receive information related to dosing schedule, reminders, and prescription adherence from the dispensing device <NUM>.

The dispensing device <NUM> can include a motor <NUM> and cam <NUM> positioned to engage a nozzle locking mechanism <NUM>. The motor <NUM>, cam, <NUM>, and nozzle locking mechanism <NUM> can have structure and/or functionality similar to structures of dispensing devices <NUM>, <NUM>, <NUM> described herein for locking nozzle position to prevent dosing, a variation thereof, or alternative thereto as understood by a person skilled in the pertinent art according to the teachings of the present disclosure.

The dispensing device <NUM> can include a motor <NUM> and cam <NUM> positioned to engage a vial locking mechanism <NUM>. The motor <NUM>, cam, <NUM>, and vial locking mechanism <NUM> can have structure and/or functionality similar to structures of dispensing devices <NUM>, <NUM>, <NUM> described herein for securing a vial within a dispensing device, a variation thereof, or alternative thereto as understood by a person skilled in the pertinent art according to the teachings of the present disclosure.

The dispensing device <NUM> can house a vial such as vial <NUM> a variation thereof, or alternative thereto as understood by a person skilled in the pertinent art according to the teachings of the present disclosure.

The dispensing device <NUM> can include a nozzle <NUM> that can be depressed to dispense medication and provide features thereon for locking and/or dose detection as described elsewhere herein, variations thereof, and alternatives thereto as understood by a person skilled in the pertinent art according to the teachings of the present disclosure.

The dispensing device <NUM> can include optical sensors <NUM> for detecting partial depression of the nozzle <NUM>, detecting presence of the vial <NUM>, detecting ingress into the dispensing device <NUM> and/or other functionality of optical sensors as described elsewhere herein, variations thereof, and alternatives thereto as understood by a person skilled in the pertinent art according to the teachings of the present disclosure.

The dispensing device <NUM> can include gestural sensors <NUM> (e.g. micro movement sensors) to detect user specific movement patterns to detect when a different user handles the device <NUM>.

Claim 1:
A device (<NUM>) comprising:
a housing (<NUM>) comprising a chamber (<NUM>) and an opening (<NUM>) in communication with the chamber;
a nozzle (<NUM>) comprising a passageway therethrough and a housing interface (<NUM>),
wherein the housing interface is sized to be positioned within the opening and configured to slidably engage the housing such that when the housing interface is slidably engaged to the housing, the nozzle is translatable from a completely extended position to a completely depressed position, and
wherein the passageway is positioned to be in communication with the chamber when the housing interface is positioned within the opening and slidably engaged to the housing; and
a first lock (<NUM>) movable from an open position to a closed position,
wherein, when the housing interface is slidably engaged to the housing and the first lock is in the closed position, the first lock inhibits depression of the housing interface of the nozzle further into the housing via the opening of the housing, and
wherein, when the housing interface is slidably engaged to the housing and the first lock is in the open position, the housing interface is uninhibited, by the first lock, from depression further into the housing via the opening of the housing;
characterized in that the device comprises:
a sensor (<NUM>) configured to provide a sensor signal indicative of a partially depressed position of the nozzle between the completely extended position and the completely depressed position; and
electrical circuitry configured to move the first lock (<NUM>) from the open position to the closed position in response to the sensor signal.