Systems and methods for detecting the use of a controlled medical treatment device

Abstract

A nasal spray device can include a housing having a sensor and a nozzle having a housing interface with a graphic image. The sensor can be configured to detect movement of the graphic image as the nozzle moves relative to the housing, for example during dispensing of medication from the nasal spray device. The sensor can include an infrared proximity sensor that detects infrared reflectance from the graphic image. The infrared proximity sensor can also be used to measure the distance of a vial in the housing to a surface, thereby detecting insertion of a vial into the housing.

Description

Technical Field

[0001] The present invention relates to systems and methods for controlling the dispensing of drugs, and more particularly, to systems and methods for dispensing drugs via a time control device coupled to a web platform.

Background Art

[0002] Conventional personal drug dispensing devices, such as nasal spray devices, are often effectively used to deliver atomized drugs. Conventional nasal spray devices consist of a pump with an elongated nozzle that atomizes the liquid as it is propelled from a supply orifice through the nozzle. The resulting mist is inhaled and efficiently absorbed by the tissue, thereby providing an effective treatment.

[0003] Nasal spray devices have been used to provide drugs for symptoms related to allergies, pain relief, and depression. For conditions such as pain relief and depression, due to the addictive nature of the drugs used to treat these conditions, there is a high risk of abuse associated with the drugs provided in the device. For example, ketamine has shown great effectiveness in the treatment of severe conditions such as bipolar depression. However, considering the addictive nature of drugs such as ketamine, healthcare providers are reluctant to administer or otherwise prescribe them for home use. Healthcare providers are often concerned about patients who are abusing or misusing drugs, people other than patients who are abusing drugs, and theft and / or sale of drugs.

[0004] Abuse and misuse are not only due to the addictive nature of the drug, but also due to the efficacy of the drug in delivering relief of the patient's condition. Patients may be driven to use more than the prescribed dosage for the relief provided by the drug. As a result, patients who need such drugs may only receive a small dosage or supply each time they visit a healthcare provider. As a result, some patients may have to visit a healthcare provider frequently, such as multiple times a week. The need for many visits to a healthcare provider is not only inconvenient, but can also act as a barrier to access to the drug for those who have to bear the burden of expensive transportation costs or cannot leave their place of employment for long periods of time. SUMMARY OF THE INVENTION

[0005] A system and method for dispensing a drug using a locking dispensing device are provided. The dispensing device can be shaped to form an exoskeleton around a pharmaceutical vial. The dispensing device can comprise one or more locking mechanisms for preventing removal of the vial and / or administration of a dosage. The system can comprise the dispensing device and a computing device linkable to the dispensing device so as to configure parameters (e.g., timeout, detection of unauthorized change, inappropriate use, biometric input, user authentication) of the dispensing device for engaging and / or disengaging the locking mechanism.

[0006] The dispensing device can comprise a nozzle and a housing that can be integrally or separately configured components that can engage slidably with each other to form an exoskeleton around the vial. The nozzle can comprise a housing interface configured to slidably engage the nozzle with the housing.

[0007] The dispensing device can comprise a vial lock that can be locked to prevent removal of the vial from the dispensing device and can be unlocked to allow removal of the dispensing device. In some examples, the vial lock can further comprise a locking portion for restricting movement of the nozzle relative to the housing (e.g., setting a fully extended position and / or a fully depressed position of the nozzle). In an example where the nozzle is separate from the housing, the vial lock can further prevent separation of the nozzle from the housing when locked and allow separation of the nozzle from the housing when unlocked.

[0008] The dispensing device can comprise a dosing lock that can be locked to prevent movement of the nozzle relative to the housing and thereby prevent administration of the medicament. The dosing lock can be unlocked to allow the nozzle to be depressed into and / or extend out of the housing, thereby allowing administration of the medicament. In an example where the nozzle is separate from the housing, the dosing lock can further prevent separation of the nozzle from the housing and / or removal of the vial from the device when locked.

[0009] The dispensing device can comprise a sensor configured to detect partial depression of the nozzle and an electrical circuit configured to lock the dosing lock in response to a signal from the sensor. The sensor can comprise an optical sensor positioned to view movement of the nozzle relative to the housing.

[0010] In an example where the nozzle is detachable from the housing, the nozzle can function to deliver the drug together with the vial without the housing. The housing can include a dosing lock and a vial lock. The nozzle can be provided with a function to engage and lock the dosing lock and / or the vial lock. The housing can be provided with a sensor for detecting the movement of the nozzle. The nozzle can be provided with a feature on the nozzle that can be detected by the sensor of the housing. The sensor and the feature on the nozzle can be positioned and otherwise configured to enable the device to detect a partial depression of the nozzle.

[0011] The present invention will be more fully understood and recognized by reading the following detailed description in conjunction with the accompanying drawings.

Brief Description of the Drawings

[0012]

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DETAILED DESCRIPTION OF THE INVENTION

[0013] Referring to the drawings, the present invention may be a system, method, and / or computer program product. The computer program product can include a computer-readable storage medium having computer-readable program instructions for causing a processor to execute aspects of the present invention.

[0014] A computer-readable storage medium can be a tangible device that holds and stores instructions for use by an instruction execution device. The computer-readable storage medium can be, for example, but not limited to, an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a semiconductor storage device, or any suitable combination of the foregoing. A non-exhaustive list of more specific examples of computer-readable storage media includes portable computer disks, hard disks, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), static random access memory (SRAM), portable compact disc read-only memory (CD-ROM), digital versatile disc (DVD), memory stick, floppy disk, mechanically encoded devices such as punch cards or raised structures in grooves in which instructions are recorded, and any suitable combination of the foregoing. As used herein, a computer-readable storage medium should not be construed to be a transitory signal itself, such as a radio wave or other freely propagating electromagnetic wave, an electromagnetic wave propagating through a waveguide or other transmission medium (e.g., an optical pulse through an optical fiber cable), or an electrical signal transmitted through a wire.

[0015] The computer-readable program instructions described herein can be downloaded from a computer-readable storage medium to respective computing / processing devices, or to an external computer or external storage device via a network, such as the Internet, a local area network, a wide area network, and / or a wireless network. The network can include copper transmission cables, optical transmission fibers, wireless transmission, routers, firewalls, switches, gateway computers, and / or edge servers. A network adapter card or network interface in each computing / processing device receives the computer-readable program instructions from the network and transfers those computer-readable program instructions for storage on a computer-readable storage medium within each respective computing / processing device.

[0016] The computer-readable program instructions for carrying out the operations of the present invention may be source code or object code written in any combination of one or more programming languages, including assembly instructions, instruction set architecture (ISA) instructions, machine instructions, machine-dependent instructions, microcode, firmware instructions, state-setting data, or conventional procedural programming languages such as the object-oriented programming languages like Smalltalk, C++, and the "C" programming language or similar program languages. The computer-readable program instructions may be executed entirely on the user's computer as a stand-alone software package, partly on the user's computer, partly on the user's computer and partly on a remote computer, or entirely on a computer or server. In the latter case, the remote computer may be connected to the user's computer via any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (e.g., via the Internet using an Internet service provider). In some embodiments, to carry out aspects of the present invention, an electronic circuit, including, for example, a programmable logic circuit, a field programmable gate array (FPGA), or a programmable logic array (PLA), can execute the computer-readable program instructions by utilizing the state information of the computer-readable program instructions to personalize the electronic circuit.

[0017] Aspects of the present invention will be described herein with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer-readable program instructions.

[0018] These computer-readable program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer, or other programmable data processing apparatus to create a machine that causes the instructions executed via the processor of the computer or other programmable data processing apparatus to implement the functions / operations specified in one or more blocks of the flowchart and / or block diagram. These computer-readable program instructions may be stored in a computer-readable storage medium and can direct a computer, programmable data processing apparatus, and / or other devices to function in a particular manner, thereby causing a product including the computer-readable storage medium storing the instructions to include an article implementing the functions / operations as specified in one or more blocks of the flowchart and / or block diagram.

[0019] 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 generate a computer-implemented process, such that the instructions executed on the computer, other programmable apparatus, or other device implement the functions / operations specified in one or more blocks of the flowchart and / or block diagram.

[0020] The flowcharts 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 of the present invention. Each block in the flowchart or block diagram may represent a module, segment, or portion of one or more executable instructions for implementing the specified logical function. In some alternative implementations, the functions described in the blocks may be performed in an order different from that shown in the figures. For example, two blocks shown in succession may, depending on the functionality involved, actually be executed substantially simultaneously, or the blocks may sometimes be executed in the reverse order. It should also be noted that each block of the block diagrams and / or flowchart diagrams, as well as combinations of blocks in the block diagrams and / or flowchart diagrams, can be implemented by a dedicated hardware-based system that performs the specified function or operation, or by a combination of dedicated hardware and computer instructions.

[0021] Referring back to the drawings, FIG. 1 shows a perspective view of an embodiment of the system according to the present invention, and like reference numerals refer to like parts throughout. FIG. 1 shows an embodiment of a system including a dispensing device 100 and a computing device 200. The computing device 200 can be a smartphone, a portable tablet, a laptop computer, a desktop computer, and any other similar device. FIG. 1 also shows the external components of an embodiment of the dispensing device 100. The dispensing device 100 includes a cylindrical housing 102 having a first closed end 104 and a second closed end 106. A nozzle 108 extends vertically from the surface 104a of the first closed end 104. The second closed end 106 can further include a base plate 106a fixed to the housing 102 with a fastener such as a star screw, thereby preventing unauthorized modification of the housing 102. Other fasteners such as magnetic fasteners, custom "keyed" screws, or similar locking devices are contemplated. The housing 102 further includes a recess 110 having a display screen 112 therein. The display screen can be a panel display such as a monochrome OLED graphic display or other LED display, for example.

[0022] Referring to FIG. 2, a schematic cross-sectional view of an embodiment of the system in the unlocked position, taken along line A, is shown. FIG. 2 shows the internal components of the dispensing device 100 in the unlocked position with the nozzle 108 depressed. The housing 102 of the dispensing device 100 further includes a first portion 114 and a second portion 116. The first portion 114 of the housing 102 is connected to both the first closed end 104 and the second portion 116.

[0023] In the illustrated embodiment, the second portion 116 of the housing 102 is connected to the second closed end 106 or the base plate 106a, providing the base of the dispensing device 100. The second portion 116 houses a liquid container 118 configured to store a liquid medical composition. In the illustrated embodiment, the liquid container 118 is cylindrical and is adapted to fit efficiently within the similarly cylindrical housing 102. An example of the cylindrical liquid container 118 is a thread-sized stock vial.

[0024] To provide access to the pharmaceutical contents of the liquid container 118, the liquid container 118 includes a pump assembly 120. In the embodiment illustrated in FIG. 2, the pump 120 is centrally disposed within the liquid container 118. The pump assembly 120 is substantially configured and operates as a standard pump assembly used in conventional nasal spray devices. When pressure is applied to the nozzle 108 toward the surface 104a of the first closed end 104, the pump assembly 120 propels the liquid medical composition stored within the liquid container 118 through a channel 122 within the nozzle 108, discharging the liquid medical composition from the dispensing device 100. Thus, in the unlocked position, the liquid medical composition can be freely discharged from the dispensing device 100.

[0025] Referring to FIGS. 3A - 3B, schematic cross-sectional views of an embodiment of the system in the locked position along lines A and B, respectively, are shown. In the illustrated embodiment, the first portion 114 of the housing 102 further includes a solenoid 124 locking mechanism therein. The solenoid 124 operates perpendicular to the movement of the pump assembly 120. In one embodiment, when the solenoid 124 is actuated, the solenoid 124 moves into the path of the nozzle 108, thereby preventing the complete movement of the nozzle 108 toward the surface 104a of the first closed end 104 and preventing the pump assembly 120 from discharging the liquid medical composition from the dispensing device 100. The solenoid 124 is shown in the unlocked position in FIG. 2 and in the locked position in FIGS. 3A - 3B. In an alternative embodiment, the solenoid 124 can include a fixture such as a U-clip that blocks the path of the nozzle 108 and interrupts the movement of the pump assembly 120.

[0026] Continuing to refer to FIGS. 3A - 3B, in the illustrated embodiment, the solenoid 124 is actuated in response to an electrical signal sent from a processor such as the printed circuit board 126. As shown in FIGS. 3A - 3B, the printed circuit board 126 is disposed within the second portion 116 of the housing 102 and is oriented towards the second closed end 106. The printed circuit board 126 is operatively connected to and powered by a battery 128 also disposed within the second portion 116 at the second closed end 106. The battery 128 can be a rechargeable lithium - ion battery or a similar type of power source.

[0027] In an alternative embodiment, the locking mechanism is the motor assembly 300. FIGS. 7A - 8C show various views of one embodiment of the locking mechanism of the motor assembly 300. First referring to FIG. 7A, a top perspective view of the motor assembly 300 is shown in the locked position. The motor assembly 300 includes a motor 302 connected to a first gear 304 disposed within an opening 306 of an internal gear 308. The internal gear 308 includes a central lock 310 through which a keyway 312 extends. Similar to the embodiment where the locking mechanism is the solenoid 124 (FIGS. 3A - 3B), the motor assembly 300 interrupts or otherwise blocks the movement of the pump assembly 120. In the embodiment shown in FIG. 7A, the shaft 314 of the pump assembly 120 extends through the central lock 310 of the internal gear 308. To facilitate locking, there is one or more keys 316 projecting from the shaft 314 of the pump assembly 120. The keys 316 are configured or fitted to slide within the keyway 312 of the central lock 310. In the embodiment shown in FIG. 7A, the keys 316 rest on the central lock 310 and sliding into the keyway 312 is prevented. Thus, the nozzle 108 attached to the pump assembly 120 is not compressible when the keys 316 are not aligned with the keyway 312.

[0028] Next, referring to FIGS. 7B to 7C, a side perspective view and a top view of the motor assembly 300 in the unlocked position are shown. From the locked position shown in FIG. 7B, the motor 302 is actuated by an electrical signal from the printed circuit board 126, and the printed circuit board 126 rotates the gear 304, thereby rotating the internal gear 308. The opening 306 of the internal gear 308 can only rotate in either direction until the internal gear 308 catches on the gear 304, thus restricting the rotation of the internal gear 308. When the internal gear 308 rotates, the lock 310 and the key groove 312 also rotate. The internal gear 308 rotates until it reaches the unlocked position shown in FIG. 7B. In the unlocked position, the key 316 on the shaft 314 of the pump assembly 120 aligns with the key groove 312 that extends through the lock 310. When the motor assembly 300 reaches the unlocked position, the nozzle 108 can be compressed. When the nozzle 108 is compressed, as shown in FIG. 7C, the key 316 on the shaft 314 of the pump assembly 120 slides within the key groove 312 of the lock 310. When the nozzle 108 is released, the key 316 on the shaft 314 slides out of the key groove 312, and the internal gear 308 may be rotated back to the locked position shown in FIG. 7A.

[0029] Next, referring to FIGS. 8A-8C, various perspective views of the first portion 114 and the second portion 116 of an embodiment of the housing 102 with the motor assembly 300 are shown. In the illustrated embodiment, the first portion 114 of the housing 102 includes the pump assembly 120, the printed circuit board 126, and the battery 128 (not shown), and the second portion 116 of the housing 102 includes the liquid container 118 (not shown). First, referring to FIG. 8B, a side view of the first portion 114 of the housing 102 and the second portion 116 of the housing 102 in the unlocked position is shown. The first portion 114 of the housing 102 has an aperture 318 along the outer periphery of its bottom surface 320. The disk 324 stacked on the bottom surface 320 of the first portion 114 of the housing 102 has a notch 326 along the outer periphery of the disk 324. The notch 326 is configured to align with the aperture 318 of the bottom surface 320 of the first portion 114. Continuing to refer to FIG. 8B, the motor 302 of the motor assembly 300 includes a second gear 322 on the side opposite the first gear 304 of the motor 302. The second gear 322 is used to rotate the disk 324 on the bottom surface 320 of the first portion 114.

[0030] Next, referring to FIG. 8A, the second portion 116 of the housing 102 includes a plurality of L-shaped flanges 328 extending from the upper surface 330 of the second portion 116. The L-shaped flanges 328 are configured to fit through the aperture 318 of the bottom surface 320 of the first portion 114 and the notch 326 of the disk 324. In the unlocked position shown in FIG. 8B, the L-shaped flanges 328 are aligned with the aperture 318 of the bottom surface 320 of the first portion 114 and the notch 326 of the disk 324. Accordingly, the second portion 116 can be pulled off from the first portion 114 of the housing 102.

[0031] To reach the lock position shown in FIG. 8C, when the motor 302 receives an electrical signal from the printed circuit board 126, it rotates the second gear 322, which in turn rotates the disk 324. The disk 324 rotates such that the notch 326 is no longer aligned with the L-shaped flange 328. Thus, the L-shaped flange 328, and thus the second portion 116 of the housing 102, cannot be removed from the first portion 114. In some embodiments, the disk 324 is spring-loaded such that the lock position is the default position of the disk 324.

[0032] The circuit described to operate the locking mechanism can also be connected to one or more signal LEDs 130 on the housing 102, as shown in FIG. 1. In one embodiment, the signal LED 130 lights up when the solenoid 124 is actuated and the dispensing device 100 is in the locked position. In an alternative embodiment, the signal LED 130 can light up red when the solenoid 124 is actuated and the dispensing device 100 is in the locked position, and green when the solenoid 124 is stopped or otherwise deactivated and the dispensing device 100 is in the unlocked position.

[0033] The circuit also connects to a screen 112 within a recess 110 of the housing 102 and supplies power to the screen 112. In the embodiments shown in FIGS. 2 and 3A, the recess 110 is surrounded by a lens 132. The lens 132 protects the screen 112 from liquids, debris, and other contaminants while still allowing the user to clearly view the screen 112. In the illustrated embodiment, the lens 132 is in the same plane as the housing 102, enabling the user to easily operate the dispensing device 100. In one embodiment, the lens 132 can include a biosensor therein. In an alternative embodiment as shown in FIG. 1, the biosensor 134 is at a separate location along the housing 102. The biosensor 134 can include a fingerprint scanner, an iris scanner, a heart rate detector, etc. The lens 132 can also be provided with a touch screen function so that the user can enter a passcode on a keypad displayed on the screen 112. The biosensor 134 and the passcode element provide an additional security layer for accessing the drug by identifying an individual using the device and sending a signal to the printed circuit board 126 to move the solenoid 124 to the unlocked position.

[0034] In some embodiments, the dispensing device 100 can further include a photocell 136 disposed within the housing and connected to the circuit. The photocell 136 detects the light state inside the device. Thus, the photocell 136 can detect when the dispensing device 100 has been illegally modified or damaged. In other embodiments, the dispensing device 100 can further include a drug sensor 138 connected to a circuit that monitors the level of the drug within the liquid container 118. Thus, the drug sensor 138 can send a signal to the printed circuit board 126 when the liquid container 118 is empty or when the remaining amount of the drug is low.

[0035] The pump assembly 120 may further include a tactile switch 140. The tactile switch 140 operates as a momentary switch that is activated when the pump assembly 120 is fully activated. The tactile switch 140 is operatively coupled to a printed circuit board 126 on which the full activation of the pump assembly 120 is recorded. The circuit from the printed circuit board 126 extends further to a real-time clock chip 142. The real-time clock chip 142 can be used to provide the date and time for display on the screen 112. As will be described later, the real-time clock chip 142 can also be used in combination with the solenoid 124 and the tactile switch 140 to lock the dispensing device 100.

[0036] Referring now to FIGS. 4 - 6, a diagrammatic representation of an embodiment of the method according to the present invention is shown. In use, the components within the dispensing device 100 can communicate with a web platform accessible on a computing device 200 to control the dispensing of the medicament. The printed circuit board 126 can utilize Bluetooth (registered trademark) low energy (BLE) as a wireless protocol for communicating with the computing device 200. Thus, the printed circuit board 126 can be programmed from the computing device 200. For example, a healthcare provider can adjust the settings on the web platform via a terminal on the computing device 200. The healthcare provider can indicate the number of doses of the medicament stored in the liquid container 118 and the minimum period between doses. This information is then transmitted to the printed circuit board 126. The printed circuit board 126 calculates the number of doses based on feedback from the tactile switch 140 and determines the period between doses based on data from the real-time clock chip 142.

[0037] In addition to programming the dispensing device 100, the web platform may be utilized by a healthcare provider to view status information from the dispensing device 100. For example, dosing times, lock status, unauthorized change warnings, and remaining dose amounts are information that may be pushed from the dispensing device 100 to the web platform via a wireless network and / or cellular data, which is ultimately accessible by the healthcare provider at a terminal on the computing device 200. Further, the web platform may also include a calendar interface or other scheduling format for tracking a patient's dosing amounts and prescription plans. Thus, the dispensing device 100, the healthcare provider's computing device 200, and the patient's smartphone (described below) can exchange status information via GSM or some other similar digital cellular network.

[0038] The biosensor 134 may be programmed by the patient in the presence of a healthcare provider. For example, the healthcare provider can adjust settings on the web platform to enable programming of the biosensor 134. The biosensor 134 can then scan the patient's fingerprint to, for example, assign a patient ID to a particular dispensing device 100. Once programmed, the biosensor 134 requires an ID check before the dispensing device 100 can be used.

[0039] Once the dispensing device 100 is programmed via the web platform on the healthcare provider's computing device 200, the patient can use the dispensing device 100. To access the medication, the patient first proves their ID by activating the biosensor 134, such as by placing a finger on the biosensor 134 for fingerprint scan verification. Once the patient's ID is verified, the patient can self-administer the first dose of the medication.

[0040] In an alternative embodiment, a patient's smartphone or other computing device can act as a second layer of authentication for accessing the dispensing device 100. For example, a patient can access a patient interface of a web platform on their smartphone. At the time of dosing, the patient may be required to authenticate themselves via the smartphone. For example, the patient can complete authentication by unlocking their phone via a passcode or fingerprint sensor. In another embodiment, a healthcare provider can send a temporary or one-time PIN code from a healthcare provider interface of the web platform to the patient interface of the web platform. Thus, the patient can access the web platform on their smartphone, retrieve the PIN code, and enter the PIN code on the dispensing device 100 to unlock it.

[0041] To administer the first dose, the patient holds the dispensing device 100 such that the nozzle 108 is proximate to or partially within the nostril and pressure is applied to the nozzle 108 toward the surface 104a of the first closure end 104. The pump assembly 120 releases the drug from the nozzle 108 so that the patient can inhale the drug. When the pump assembly 120 is actuated, the tactile switch 140 is also triggered. The tactile switch 140 sends a signal indicating that the pump assembly 120 has been actuated to the printed circuit board 126, indicating that the dose has been administered. At the same time, the printed circuit board 126 associates the signal from the tactile switch 140 with the time provided by the real-time clock chip 142.

[0042] When a healthcare provider sets a minimum period between doses, reception of a signal from the tactile switch 140 also activates the solenoid 124 on the printed circuit board 126. The solenoid 124 moves into the path of the nozzle 108, thereby preventing the patient from administering the next dose of the drug. The dispensing device 100 remains in a locked position where the solenoid 124 blocks the actuation of the nozzle 108 until the minimum period has elapsed. The printed circuit board 126 can monitor time using data received from the real-time clock chip 142. When the minimum period has elapsed after actuation of the tactile switch 140, the printed circuit board 126 triggers the solenoid 124 to retract, thereby enabling the patient to fully depress the nozzle 108 and administer the next dose. Thereafter, the locking process is repeated.

[0043] In embodiments where one or more signal LEDs 130 are disposed on the housing 102, the signal LEDs can illuminate red when the solenoid 124 is within the path of the nozzle 108, indicating that a dose is not being administered, and illuminate green when the solenoid 124 is retracted, informing the patient that a subsequent dose is available. Since the printed circuit board 126 can communicate wirelessly with the computing device 200, a signal from the printed circuit board 126 can be transmitted to the computing device 200 to alert the patient that a next dose is available. In an alternative embodiment, a drug sensor 138 can send a signal to the printed circuit board 126 indicating that the liquid container 118 is empty or that the remaining amount of drug is low, and ultimately to the computing device 200. This alerts the patient to initiate the process of refilling the prescription.

[0044] In an embodiment where the housing 102 includes a photocell 136, the photocell 136 can be configured to send a signal to the printed circuit board 126 when it detects light exceeding a programmed threshold. The printed circuit board 126 can be programmed to send a signal to a computing device 200 accessible to a healthcare provider. The signal can appear as a warning on a web platform notifying the healthcare provider that the dispensing device 100 has been tampered with. In an additional embodiment, the printed circuit board 126 can be programmed to send data from any component or combination of components of the dispensing device 100 to a computing device 200 operated by a healthcare provider and / or a patient. The healthcare provider and the patient can then access this data to improve compliance with the treatment plan.

[0045] Figures 9 - 15, 17, 18A, and 18B each show two additional embodiments of dispensing devices 400, 600. The components and / or design strategies of the various dispensing device embodiments 100, 400, 600 are combinable or interchangeable as would be understood by one of ordinary skill in the relevant art in accordance with the teachings of the present disclosure. For example, although not explicitly shown, the additional embodiments 400, 600 can include signal LEDs 130, lenses 132, screens 112, photocells 136, drug sensors 138, tactile switches 140, real-time clocks 142, any combination thereof, or variations thereof. Similarly, the additional embodiments 400, 600 can include appropriate electrical circuitry and mechanical structures to support such components.

[0046] One of the illustrated embodiments 400 includes sensors 442, 444, 446 (FIG. 14B) and visual features 490, 492, 494 (FIG. 10) for detecting the depression level of nozzle 460. Such sensors and visual features can be incorporated into embodiments 100, 600 of other dispensing devices shown herein or variations thereof, as would be understood by those of ordinary skill in the relevant art in accordance with the teachings of the present disclosure. When the nozzle is partially depressed over a long period of time and / or when the user performs a partial depression and returns the nozzle to its fully extended position, dispensing devices 100, 400, 600 can be configured to lock nozzles 108, 460, 660. This prevents the user from attempting to avoid the security of dispensing devices 100, 400, 600 and administering multiple partial doses.

[0047] Dispensing devices 100, 400, 600 can further include ratchet-type dosing locks such as dosing lock 420 shown in FIG. 13 and dosing lock 620 shown in FIG. 18A. The illustrated dosing locks 420, 620 are in a locked position and, when the nozzle is partially depressed, allow nozzles 460, 660 to return to their fully extended position and prevent further depression of the nozzle by ratcheting. Alternatively, the ratchet may be shaped to allow the nozzle to be depressed and prevent extension of the nozzle. Each design has several advantages. For example, a lockout ratchet (which prevents depression of the nozzle) immediately prevents further dosing when the lock is engaged, which can be a desirable function when preventing overdosage of a drug is the main concern. A dosing enforcement ratchet (which prevents extension of the nozzle) can prevent partial depression from occurring when the lock is engaged, but does not prevent completion of dosing. This can be a desirable function when preventing small doses of a drug is the main concern.

[0048] Additional embodiments 400, 600 can function with one or more computing devices such as computing device 200 shown in FIG. 1, other computing devices disclosed herein, and / or one or more computing devices as would be understood by those of ordinary skill in the relevant art in accordance with the teachings of the present disclosure. Methods shown in FIGS. 4 - 6 can be performed using dispensing devices 400, 600. Dispensing devices 400, 600 can connect directly and / or remotely to a computing device (e.g., the illustrated computing device 200) via Wi-Fi / , Bluetooth®, cellular, etc. to control the dispensing devices 400, 600 (lock / unlock, load biometrics / load new nasal spray device / change dosing schedule). Dispensing devices 400, 600 can communicate with computing device 200 and can warn a physician via push notification if a patient has missed a dose or has tampered with the device. Dispensing devices 400, 600 can be configured to generate an output for reminding a patient of when to take a dose (e.g., by a physician). The output can be many different outputs known in the art including, but not limited to, light, display, sound, or other warnings or communications to another device such as the patient's mobile phone. Dispensing devices 400, 600 can further monitor the patient's use of the dispensing devices 400, 600 and provide information / data regarding the patient's use directly to computing device 200 via a display or other means on devices 400, 600 to notify a physician regarding the patient's medication compliance. Dispensing devices 400, 600 can have a timed lockout (preset by a physician) and / or a scheduled lockout. The timed lockout can be preset by an authorized user (e.g., a physician). The scheduled lockout can be set and / or edited remotely via a web platform (or other network-connected platform) accessible via a physician's computing device.

[0049] Both options still require the patient's authentication information to unlock the device. This can be done using a biometric scanner on the device or, in the future, using the biometric (fingerprint / face / iris) scanning function on the user's mobile phone.

[0050] Typically, the dispensing devices 400, 600 provide safe drug delivery and include disposable components that contain the drug and reusable exoskeleton or housing components. The exoskeleton secures the disposable portion that contains the drug / drug product and controls how and when the substance is dispensed. In some embodiments, the exoskeleton can secure (e.g., encapsulate) a standardized nasal spray device 500. The exoskeleton can lock and unlock the nozzle movement of the standardized nasal sprayer 500. The locking and unlocking of the devices 400, 600 (dispensing) can be remotely (Wi-Fi / BT) controlled and / or configured via a mobile phone application and a web platform as prescribed by a doctor / physician. The nozzle can include details of the lock that interacts with the exoskeleton locking mechanism.

[0051] The standardized nasal spray device / vial 500 can be inserted into the outer skeleton from locations including, but not limited to, the top (see dispensing device 400 shown in FIGS. 9 - 15) and the bottom (see dispensing device 600 shown in FIGS. 17, 18A, and 18B). The top-loading dispensing device 400 can include a nozzle 460 that can be detached from the housing 402. The nozzle 460 can be disposable and attachable to a standardized nasal sprayer. Alternatively, a custom disposable vial can be constructed that includes a nozzle portion following the design strategy of the disposable nozzle 460. Since the nozzle 460 of the top-loading dispensing device 400 is disposable, the nozzle 460 can be discarded and / or cleaned separately from the reusable housing 402 of the device 400, thereby potentially providing a better hygienic condition compared to the bottom-loading dispensing device 600. The bottom-loading device 600 can be configured to receive a standard vial 500 without the need for a dedicated nozzle 460, and thus can potentially be more convenient and / or cost-saving compared to the top-loading device 400.

[0052] The dispensing devices 400, 600 can include sensors (e.g., light / imaging) for detecting nozzle movement and unauthorized device modification, a micro-motion sensor for detecting a user-specific movement pattern to detect when different users are handling the devices 400, 600, and / or a drug neutralizer (e.g., powder or sponge) for chemically neutralizing the drug released from the internal vial 500. As discussed above and understood by those skilled in the art, one or more of these features can be combined and / or exchanged with the features of the device 100.

[0053] Here, the details of each additional embodiment 400, 600 will be discussed in relation to the drawings.

[0054] FIG. 9 is a side view of a top-loading dispensing device 400 according to the present invention. The dispensing device 400 includes a housing 402 and a nozzle 460, which together form an outer skeleton that (at least partially) surrounds and secures a vial 500 (FIG. 10).

[0055] The nozzle 460 and the vial 500 shown in FIG. 10 are snap-engaged together. The nozzle 460 includes a housing interface 480 that snap-engages onto the vial 500, which enables the nozzle 460 to be pushed down and provides features for locking the combined nozzle 460 and vial 500 within the housing 402. The combined nozzle 460 and vial 500 can function to deliver the drug both with and without the housing 402, whether they are fitted during manufacture or after manufacture, which allows a healthcare provider to select whether the drug within the housing 402 is provided when a particular patient is administered a particular drug. Since the nozzle 460 is not integrated with the housing 402, the nozzle 460 can be discarded or cleaned separately from the housing 402, which potentially results in a more hygienic product compared to a reusable dispensing device with an integrated nozzle. Further, the opening 412 through which the nozzle 460 slides during operation is the same opening through which the vial is removed, eliminating the need for a second opening for vial removal. Without a second opening for vial removal, the cover 418 of the housing 402 can have a smoother, and thus potentially more tamper-resistant, outer surface.

[0056] Device 400 is oriented vertically about a longitudinal axis L-L that intersects orthogonal planes A and B. Housing 402 has a first upper end 404 having a first upper surface 404a that is orthogonal to longitudinal axis L-L and planes A and B. Housing 402 has a second lower end 406 having a second bottom surface 406b that is substantially parallel to first surface 404a. Nozzle 460 extends vertically from upper surface 404a of housing 402. Housing 402 has an opening 412 in upper surface 404a, and nozzle 460 has a housing interface 480 that is positioned within opening 412 and configured to slidably engage housing 402. As shown, when nozzle 460 is slidably engaged with housing 402 and nozzle 460 is unlocked, nozzle 460 is translatable from a fully extended position as shown in FIG. 9 to a fully depressed position, and in the fully depressed position, bottom surface 470 of engagement ring 466 of nozzle 460 approaches upper surface 404a of housing 402 in a manner similar to the depressed position of nozzle 108 relative to housing surface 104a as shown in FIG. 2.

[0057] As used herein, the terms "fully extended position" and "fully depressed position" refer to the two extremes between which the nozzle moves for its intended purpose of providing a dosage.

[0058] Housing 402 can further include a biosensor 408 that can function similarly to biosensor 134 described elsewhere herein. For example, a fingerprint scan on sensor 408 can be used by the electrical circuitry of device 400 to determine whether to unlock a dosing lock. Additionally or alternatively, a fingerprint scan on the sensor (e.g., by a physician) can be used by the electrical circuitry of device 400 to determine whether to unlock a vial. Housing 402 can include a finger cover 410. Finger cover 410 can include a display, and / or the display can be positioned elsewhere on housing 402.

[0059] The display can function in the same manner as the display 112 described elsewhere in this specification.

[0060] The device 400 can further include a removable nozzle cap 461.

[0061] FIG. 10 is a side view of the nozzle 460 engaged with the pharmaceutical vial 500 in the same orientation as FIG. 9. Referring collectively to FIGS. 9 and 10, the assembled nozzle 460 and vial 500 in FIG. 10 are removable from the housing 402 in FIG. 9 without damaging the housing 402, preferably without damaging the nozzle 460. During use, the nozzle 460 and vial 500 are interchangeable and preferably disposable. The housing 402 can be reloaded with a new nozzle 460 and vial 500 assembly. The pharmaceutical vial 500 can be loaded through an opening 412 in the upper surface 404a of the housing 402. Accordingly, the housing 402 includes a chamber 414 (FIG. 13) sized to receive the pharmaceutical vial 500, and the chamber 414 is accessible through the opening 412 in the upper surface 404a of the housing 402.

[0062] The outer surface of the housing 402 can completely eliminate fasteners or other externally accessible means for opening the device 400 when assembled to the nozzle 460. In some applications, it may be desirable to provide an outlet 419 to allow the liquid discharged from the vial 500 within the device 400 to exit the device 400. In other applications, it may be desirable to capture the liquid discharged from the vial 500 within the device 400 (e.g., the sponge within the chamber 414 shown in FIGS. 14A and 14B).

[0063] Figures 11A and 11B are orthogonal side views of nozzle 460 and vial 500, where Figure 11A shows the left side of the assembly shown in Figure 10, and Figure 11B shows the right side of the assembly shown in Figure 10. Figure 12 is a view of the assembly shown in Figures 10, 11A, 11B with nozzle 460 removed. Referring collectively to Figures 10, 11A, 11B and 12, nozzle 460 includes a conical portion 462, an engagement ring 466, a housing interface 480, a spring 478, and a retaining ring 476. Preferably, the conical portion 462, the engagement ring 466, and the housing interface 480 are molded as a single-piece handle portion 463. Alternatively, at least one of the conical portion 462, the engagement ring 466, and the housing interface 480 can be molded individually and assembled together to form the handle portion 463.

[0064] The conical portion 462 has a dispensing end 472, a base end 474, and a fluid passage 464 that extends along the longitudinal axis L-L through the base end 474 and the dispensing end 474. The engagement ring 466 extends radially from the base end 474 of the conical portion and provides an upper surface 468 against which a user can provide a force to push down the nozzle 460. The bottom surface 470 of the engagement ring 466 faces away from the dispensing end 472. When the device 400 is assembled to prevent further pushing down of the housing interface 480 into the housing 402, the bottom surface 470 can be further shaped or otherwise configured to contact the upper surface 404a of the housing 402. The housing interface 480 has an outer surface 482 that surrounds the longitudinal axis L-L, an upper end 484 attached to the engagement ring 466, an open lower end 486, and a passage 488 that extends between the upper end 484 and the lower end 486. Since the vial 500 and the nozzle 460 are pre-assembled during manufacture, no further assembly is required on the part of the healthcare provider, thus providing further convenience.

[0065] The nozzle 460 can be fitted to the vial 500 by first placing the retaining ring 476 and spring 478 over the vial 500 and then sliding the housing interface 480 over the spring and retaining ring 476. The housing interface 480 can be provided with a flexible hook 481 that moves over the vial 500 and snaps under a ridge on the vial to engage and secure the nozzle 460 to the vial 500. The inner sides of the conical portion 462 and engagement ring 466 can be shaped to fit over the vial nozzle. The vial and nozzle assembly can further include an adapter or vial nozzle cover that assists in meshing the nozzle 460 with the vial 500. In this way, the nozzle 460 can be fitted onto an existing standard-sized vial. Alternatively, the vial 500 and nozzle 460 may be specially designed together and / or integrally.

[0066] The nozzle 460 includes features that function in conjunction with the housing 402 to control the dispensing of the drug within the vial 500, as will be described in more detail below. As shown in FIGS. 10, 11A, and 11B, the drug can also be dispensed when the nozzle 460 and vial assembly are outside the housing. This can allow the drug to be packaged in the same way whether it is intended to be adjusted during use or not, thereby increasing convenience and potentially reducing costs.

[0067] Referring to FIG. 10, the housing interface includes openings 490, 492, 494 in the outer surface 482 that assist in detecting partial depression of the nozzle 460. When the nozzle 460 is depressed over the vial 500, the movement of the housing interface 480 relative to a portion of the nozzle 460, such as the retaining ring 476, becomes visible through the openings 490, 492, 494. The housing 402 can include one or more sensors that detect the movement of a portion of the nozzle 460 (e.g., the retaining ring 476) over the openings 490, 492, 494. FIG. 10 shows three openings 490, 492, 494 positioned such that three positions of depression of the nozzle 460 can be detected. The housing interface 480 can include one or more such openings 490, 492, 494 to serve the same purpose, where the maximum number of openings is limited by physical design constraints as will be understood by those of ordinary skill in the art in accordance with the teachings of the present disclosure. Preferably, the outer surface 482 of the housing interface 480 provides a high visual contrast with the retaining ring 476, whereby the retaining ring 476 can be easily visualized relative to the housing interface 480 by an optical sensor. When the assembly of the nozzle 460 and the vial 500 is installed within the housing 402, the retaining ring 476 is substantially stationary relative to the optical sensor, while the openings 490, 492, 494 move to cover and uncover the view of the optical sensor of the retaining ring 476. The optical sensor checks for movement at the start and end of dosing by detecting the movement of the upper and lower openings 490, 494 on the housing interface 480. If dosing has started but the nozzle has not been depressed to the bottom, the dosing lock 420 engages (described in more detail in connection with FIGS. 13 and 14B).

[0068] As shown in FIGS. 10 and 11A, the housing interface 480 includes a notch 496 for locking the depression of the nozzle 460 into the housing 402, i.e., for preventing the user from receiving a dose. Two notches 496 are shown. The lower notch is positioned to maintain the nozzle in a fully extended position when the housing interface 480 is slidably engaged with the housing 402.

[0069] FIGS. 13 and 14B show a housing dosing lock 420 that engages a notch 496 on the nozzle 460.

[0070] Referring collectively to FIGS. 10, 11A, 13, and 14B, during the intended use of device 400, the user is able to return the nozzle to its fully extended position after each administration of the pharmaceutical, and upon completion of the administration, nozzle 460 is locked in its fully extended position by engaging the lower notch with dosing lock 420. However, the user may inadvertently or intentionally partially depress the nozzle simultaneously with the engagement of dosing lock 420 of housing 402 (see FIGS. 13 and 14B). In this case, the upper notch is positioned to engage dosing lock 420 and prevent further depression of the nozzle when the nozzle is partially depressed. At least, the upper notch has an angled shape such that, despite the nozzle 460 being prevented from further depression, the vial lock slides downwardly away from notch 496 and allows the nozzle 460 to extend further from housing 402. In use, if the upper notch is engaged by the vial when the nozzle 460 is locked at the time the downward force is removed from the nozzle 460, spring 478 pushes the nozzle 460 towards its fully extended position outside of housing 402. Thus, dosing lock 420 can slide from the upper notch to the lower notch. Although one upper notch is shown, housing 402 can further include additional angled notches positioned to engage the vial lock when the nozzle 460 is depressed to a plurality of partial depression positions. Thus, the angled notches can function as a ratchet, allowing movement of the nozzle 460 in one direction when the vial lock is engaged. The number and position of the angled notches can be determined by physical design constraints, as understood by those skilled in the art.

[0071] Accordingly, the ratchet operation of the dosing lock 420 can lock out a user who attempts to defeat the dosing lock 420 when the user dispenses a dose (by depressing the nozzle 460), then releases the nozzle 460 slowly towards the extended position, stops just short of reaching the fully extended position and engaging the lower notch 496 (see also FIG. 13), and then attempts to depress the nozzle 460 again.

[0072] Referring to FIG. 11B, the housing interface 480 can further include a vial lock opening 498. The vial lock opening 498 can be shaped, sized, and otherwise configured to engage a vial lock 430 (see FIGS. 13 and 14B) of the housing 402. When the vial lock extends into the opening 498, engagement of the vial lock with the lower ledge 499 of the opening 498 can prevent the nozzle from being pulled out of the housing 402. The opening 498 can be sized such that the vial lock can pass freely through the opening 498 when the nozzle 460 is depressed to deliver the medicament. The opening can further be sized such that the vial lock engages the upper ledge 497 of the opening 498 and sets the fully extended position of the nozzle 460. Alternatively, the fully extended position of the nozzle 460 can be set and / or assisted through engagement of additional features on the housing 402 with the housing interface 480 as would be understood by one of ordinary skill in the art in accordance with the teachings of the present disclosure.

[0073] FIG. 13 is a cross-sectional view of the device 400 taken along plane B in the orientation as shown in FIG. 9. Some of the components of the housing 402 have been removed to emphasize the dosing lock 420 and the vial lock 430. Further components of the housing 402, including the chassis 416, are shown in FIGS. 14B and 15.

[0074] Each of the locks 420, 430 includes a motor 426, 436, a cam 424, 434, and a sliding extension 422, 432, respectively. When the nozzle 460 is in the fully extended position as shown, the sliding extension 422 of the dosing lock engages the lower notch 496 on the housing interface 480, and the sliding extension 432 of the vial lock engages the lower ledge 499 of the vial lock opening 498 of the housing interface 480.

[0075] When the dosing lock 420 and the vial lock 430 are both locked and the nozzle is in the fully extended position, the dosing lock 420 prevents the nozzle 460 from being pushed down, and the vial lock prevents the nozzle 460 from extending. When the dosing lock 420 is open, the vial lock 430 provides a locking portion that sets the fully depressed position of the nozzle 460.

[0076] The lower ledge 499 and the bottom of the vial lock opening 498 that fit the surface of the sliding extension 432 of the vial lock 430 are each angled downward and inward. In this position, the vial lock 430 is prevented from disengaging the housing interface 480 while the dosing lock 420 is engaged with the lower notch 496. If a user attempts to pull the nozzle 460 out of the housing 402, the sliding extension 432 slides relative to the lower ledge 499 and further extends into the housing interface 480, thereby enabling further engagement with the housing interface 480.

[0077] To remove the nozzle 460 and the vial 500, an authorized user (e.g., a physician or pharmacist) sends a command to the dispensing device 400 to remove the vial 500. The dosing lock 420 disengages, and the authorized user pushes down the nozzle 460 to disengage the cut-off of the housing interface 480. A sensor (e.g., an optical sensor that views one or more openings 490, 492, 494) detects that the nozzle 460 is being pushed down, the vial lock 430 is unlocked, and then the vial 500 can be removed.

[0078] The release of each lock 420, 430 can include rotation of respective motors 426, 436 that rotate respective cams 242, 434 to slide respective sliding extensions 422, 432 outwardly away from the housing interface 480, thereby disengaging the housing interface 480. The closure of each lock 420, 430 can include reverse rotation of respective motors 426, 436 that rotate respective cams 242, 434 in a direction opposite to release to free respective sliding extensions 422, 432, and springs 428, 438 (see FIG. 14B) press respective sliding extensions 422, 432 toward the housing interface 480, thereby engaging the housing interface 480.

[0079] The dosing lock 420 can include an angled sliding extension 422 shaped to engage a notch 496 in the housing interface 480 of the nozzle 460. The extension 422 of the dosing lock 420 can ratchet over a plurality of notches 496 (see FIG. 11A).

[0080] FIGS. 14A and 14B are respectively top views of the housing 402 orthogonal to planes A and B. FIG. 14B is a cross-sectional view of the housing 402 taken along plane C shown in FIG. 13.

[0081] FIG. 14A shows the upper surface 404a, the opening 412, the chamber cavity 414, the sliding extension 422 of the dosing lock 420, and the sliding extension 432 of the vial lock 430. The vial lock 430 includes upper and lower fins. As shown in FIG. 13, the lower fin is shaped to engage the lower ledge 499 of the vial lock opening 490 of the housing interface 480 of the nozzle 460. The upper fin is shaped to engage the upper ledge 497 of the vial lock opening 498 to set the fully extended position of the nozzle 460. The opening 412 includes a key extension 413. The housing interface 480 is scored on the side shown in FIG. 10 to properly orient the nozzle 460 when the housing interface 480 is inserted into the opening 412.

[0082] FIG. 14B shows additional component parts of the housing 402 and the locks 420, 430. Each lock 420, 430 includes respective springs 428, 438 attached to respective sliding extensions 422, 432 to move the locks 420, 430 to their closed positions when their respective cams are positioned as shown. The cams 424, 434 are positioned as mirror images of each other, or alternatively may be positioned in other forms as would be understood by one of ordinary skill in the art in accordance with the teachings of the present disclosure. To release the locks 420, 430, the cam 424 of the dosing lock 420 rotates clockwise and the cam 434 of the vial lock 430 rotates counterclockwise (i.e., in the opposite direction due to the mirror symmetry of the cams 424, 434). As each of the cams 424, 434 rotates, they engage respective bumps 423, 433 on their respective sliding extensions 422, 432, thereby pushing the springs 428, 438 and moving the sliding extensions 422, 432 outward toward the open position. The bumps 423, 433 are centered on their respective sliding extensions 422, 432 to minimize lateral movement of the extensions 422, 432, thereby reducing the risk of jamming the locks compared to misaligned engagement. The bumps 423, 433 and the cams 424, 434 are preferably configured such that the cams 424, 434 have a small contact area and thus low friction compared to a larger contact area.

[0083] Another option is to rotate one or both of the cams 424, 434 more than 90 degrees over the bumps 423, 433. This option does not rely on the friction of the motor gearbox to keep the locks 420, 430 released, thus allowing more options for motor selection.

[0084] Each lock 420, 430 includes locking portions 415, 417 that are pushed by the vertical extensions 425, 435 of the respective cams 424, 434 when the cam reaches the end of its rotational movement. Each locking portion 415, 417 is preferably integrated with the chassis 416 of the housing 402 (see also FIG. 15) rather than with the respective sliding extensions 422, 432. The locking portions 415, 417 integrated with the chassis 416 can reduce the likelihood of rotation (and thus jamming) of the respective sliding extensions 422, 432 when the respective cams 424, 434 are engaged with the respective locking portions 415, 417 as compared to locking portions integrated with the sliding extensions 422, 432. The chassis 416 can also provide or engage with a structural support for the springs 428, 438 and the motors 426, 436.

[0085] Continuing to refer to FIG. 14B, the housing 402 includes a printed circuit board 440 to which electrical components are connected, and together they form an electrical circuit for performing various functions of the device 400. The circuit board 440 can include a processor and a non-transitory computer-readable medium having instructions that, when executed by the processor, cause the electrical circuit to perform the functions described herein, including the functions described in connection with the system shown in FIG. 1. The circuit board 440 need not take a particular form as shown. The electrical circuit of the housing 402 can include, for example, a rigid board, a flexible circuit, discrete components, free wiring, and / or combinations thereof. Using some form of the electrical circuit, the functions described herein can be performed as understood by those skilled in the art in accordance with the teachings of the present disclosure. The electrical circuit of the device 400 can further include a drug sensor 138, a tactile switch 140, and / or a real-time clock as described elsewhere in this specification.

[0086] The electrical circuit includes three optical sensors 442, 444, 446 mounted on a circuit board 440. Each sensor 442, 444, 446 is positioned to view respective openings 494, 492, 490 within a housing interface 480 of the nozzle 460. Each sensor 442, 444, 446 is configured to provide a sensor signal indicative of a depressed position of the housing interface. At least the central sensor 444 is positioned to provide a sensor signal indicative of a partially depressed position of the nozzle between a fully extended position and a fully depressed position. Monitoring the partial depression of the nozzle 460 can be useful for determining drug administration and / or for preventing unauthorized changes. In some embodiments, the electrical circuit can be configured to close the dosing lock 420 in response to receiving a sensor signal from the central sensor indicative of a partially depressed position and / or repeated partial depressions of the nozzle 460 over time. In some embodiments, the processor is configured to receive the sensor signal, execute instructions in memory to activate a motor 426 in the electrical circuit, thereby rotating a cam 424 and closing the lock 420.

[0087] Device 400 can include additional or alternative sensors and / or indicators for detecting partial depression of nozzle 460. As one example, housing interface 480 can include a high contrast image instead of a series of openings such as horizontal lines across outer surface 482 of housing interface 480. When nozzle 460 is depressed, the electrical circuit can determine the number of lines passing in front of one or more of optical sensors 442, 444, 446 based on signals from the sensors. Additionally or alternatively, the horizontal lines can vary in thickness, thereby creating distinct sensor signals depending on which lines are being viewed by the optical sensors. As another example, housing interface 480 can include a conductive strip, and circuit board 440 can include two or more contacts positioned to electrically contact the conductive strip simultaneously when nozzle 460 is partially depressed. The electrical circuit of housing 402 can detect when the contacts short circuit, thereby detecting partial depression of nozzle 460 at one or more partial depression positions.

[0088] Using upper and lower openings 490, 494, it can be determined when nozzle 460 is in a fully extended position or a fully depressed position. Alternatively, housing 402 can include limit switches for detecting when nozzle 460 is in a fully extended and / or fully depressed position.

[0089] Engagement of cams 424, 434 with latches 415, 417 can be detected by monitoring the current to respective motors 426, 436. When the electrical circuit detects an increase in current above a predetermined threshold (such as provided by instructions in memory), the electrical circuit can reduce or remove power to motors 426, 436.

[0090] The electrical circuit can further include sensors (such as optical sensors) for detection of vial 500.

[0091] The electrical circuit section can be powered by a battery 448 integrated into the housing 402. The electrical circuit can include a battery charge regulation and battery protection circuit (e.g., overvoltage, undervoltage, overcurrent, etc.).

[0092] The electrical circuit can be configured to hold a dosing lock 420 for a set dosage amount (e.g., input by a physician or pharmacist), and then return the dosing lock 420 to the closed position / locked position. When returning to the closed position / locked position, the spring 428 pushes the dosing lock extension 422 to engage with the housing interface 480.

[0093] FIG. 15 shows an exploded view of the components of the device 400 and the vial 500. The nozzle 460 includes a handle portion 463, a spring 478, and a retaining ring 476. The vial 500 includes a liquid container 502, an atomizer 504, and a vial nozzle 508. The housing 402 includes an upper cover 451, an optical guide 453, and an upper ring 454, which together form the upper surface 404a of the housing 402. The housing 402 further includes an LED substrate 452 including a light-emitting diode (LED) positioned to illuminate the optical guide 453. The same or additional LEDs can provide illumination for an optical sensor within the housing 402. The components of the dosing lock 420 and the vial lock 430 are fixed to the chassis 416 by respective lock covers 427, 437. The circuit board 440 includes a mounted scan nest 456 to which a biosensor 408 can be mounted. The lock covers 427, 437 and the circuit board 440 are attached to the chassis by screws 455. Of course, alternative fasteners, adhesives, snaps, or other strategies can be used to fix the components to the chassis 416 and / or within the housing 402 as understood by those skilled in the art in accordance with the teachings of the present disclosure.

[0094] The housing 402 can be charged by inductive charging. The housing 402 includes an induction coil 450 positioned near the lower end 406 of the device 400 inside the cover 418. The cover 418 can include a co-molded ring 457 near the lower end 406 for additional stability to prevent the device 400 from tipping over during charging. The electronic circuit portion of the housing 402 can include a circuit for inductively charging the battery 448 using the coil 450, including circuits designed according to currently available inductive chargers and other such wireless charging methods that have not yet been developed. By incorporating wireless charging into the housing, the need for a charging port is eliminated, thereby eliminating an entry point for the user and thus providing a more robust device against unauthorized modification compared to devices having a wired charging port. Further, since the user does not have direct access to the charging mechanism, a device having wireless charging can be made more resistant to damage (at least to the charging circuit) compared to a device having a wired charging port.

[0095] The entire assembly has no exposed screws by virtue of the cover 418 that clips onto the chassis 416. Before the cover 418 is clipped on, the functions of the mechanical and electrical components can be assembled and tested on the chassis 416.

[0096] Figures 16A - 16C are diagrams of an alternative handle portion 463 of the nozzle of the dispensing device 400 shown in FIGS. 11A and 11B. The handle portion 463 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 465 that can engage with each other to fix the upper portion 463a to the lower portion 463b in a tamper - resistant manner, which means that the upper portion 463a and the lower portion 463b cannot be easily separated by the recipient of the drug. The handle portion 463 can be provided with a cradle 467 sized to accommodate the push - down tab 510 of the vial nozzle 508 (see FIG. 15). The cradle 467 can be sized to accommodate a larger push - down tab 510 such as can be seen on many pharmaceutical vials 500 currently in use in the industry.

[0097] As shown in FIGS. 16A - 16C, the nozzle 460 of the dispensing device 400 having a handle portion 463 removes the vial nozzle 508 from the vial 500, places the retaining ring 476 and spring 478 over the vial 500, slides the housing interface 480 over the spring and retaining ring 476, places the vial nozzle 508 over the vial 500 such that the push - down tab 510 is positioned within the cradle 467 of the lower portion 463b of the handle portion 463, snap - engages the upper portion 463a of the handle portion 463 over the vial nozzle 508, and secures the lower portion 463b of the handle portion 463, thereby fitting it onto the vial 500. The sequence of attaching the nozzle 460 to the vial 500 may be performed in a variety of ways, and the steps may be performed in an order different from that listed, as would be understood by those skilled in the art. For example, the vial nozzle 408, spring, and / or retaining ring 476 may be secured within the handle portion 463 before the vial 500 is inserted into the handle portion 463. The housing interface 480 may be provided with a flexible hook 481 that moves over the vial 500 and snap - engages under a ridge on the vial to engage and secure the nozzle 460 to the vial 500. When the nozzle 460 of the dispensing device is attached to the vial 500, the nozzle 460 can be inserted into the housing 402, and the dispensing device 400 can function as described with respect to FIGS. 9 - 15.

[0098] FIGS. 16A - 16C show one exemplary geometry of a handle portion 463 having discrete parts that can secure the vial nozzle 508 in a form that prevents unauthorized alteration. As would be understood by those skilled in the art, other alternative forms may be constructed that include a handle portion 463 with two vertically - split parts and / or three or more discrete parts.

[0099] FIG. 17 shows a developed view of another embodiment of the dispensing device 600 according to the present invention. FIG. 18A shows a cross-sectional view of the dispensing device in plane A as shown in FIG. 17. FIG. 18B shows a cross-sectional view of the dispensing device in plane B as shown in FIG. 17.

[0100] The dispensing device 600 shown in FIG. 17 differs from the device 400 shown in FIGS. 9-15 in that the vial 500 is loadable from the bottom of the device 600 and the nozzle is integral with the housing (i.e., cannot be detached without damage or without special disassembly). The dispensing device 600 shown in FIG. 17 can have electrical circuits and components (e.g., mechanical and / or electrical parts) for partial dosage detection, biometric scanning, wireless and / or wired communication to other computing devices, programmability for timed dosages, tremor detection, drug identification, dosage detection, and other functions as described for other dispensing device embodiments 100, 400 elsewhere in this specification.

[0101] Referring collectively to FIGS. 17, 18A, and 18B, the dispensing device 600 includes a handle portion 663, an upper cover 651, an LED substrate 652, an optical guide 653, an upper rim 654, a housing interface 680, a spring 678, a chassis 616, a battery 648, a biometric sensor 608, a sliding dosing lock extension 622, a dosing lock cam 624, a dosing lock motor 626, a C-shaped vial lock extension 632, a vial lock cam 634, a vial lock motor 636, a circuit board 640, a cover 618, a finger cover 610, a cover co-molding 657, and a base 658.

[0102] The upper cover 651, LED substrate 652, optical guide 653, and upper rim 654 are assembled similarly to the corresponding components 451, 452, 453, 454 of the dispensing device 400 shown in FIGS. 9-15.

[0103] The nozzle of device 600 includes a handle portion 663, a spring 678, and a housing interface 680. The handle portion 663 includes a conical portion and an engagement ring similar to the conical portion 462 and the engagement ring 466 of the handle portion 463 of the nozzle 460 of the dispensing device 400 shown in FIGS. 9-15. The handle portion 663 and the housing interface 680 clip to each other.

[0104] The housing interface 680 has an outer surface 682 that includes features for detecting a partial depression of the nozzle similar to the features on the outer surface 482 of the housing interface 480 of the dispensing device 400 shown in FIGS. 9-15. Similarly, the electrical circuit of device 600 (i.e., circuit board 640 and other electrical components) includes sensors for detecting the position and / or movement of features on the housing interface 680.

[0105] Device 600 includes a limit switch that detects when the nozzle of device 600 is in a fully extended and / or fully depressed position. Additionally or alternatively, device 600 can include openings in the housing interface 480 similar to the openings 490, 494 of the device 400 shown in FIG. 10 for detecting when the nozzle of device 600 is in a fully extended and / or fully depressed position.

[0106] The housing interface 680 further includes a notch 696 positioned to engage the dosing lock extension 622. The notch 696 can be angled to prevent nozzle depression and allow extension when the handle 663 is partially depressed. The dosing lock 620 (including the dosing lock extension 622, cam 624, and motor 626) can ratchet over the notch 696, similar to the function of the dosing lock 420 and notch 496 of the device 400 shown in FIGS. 9-15. The dosing lock extension 622 includes an angled ledge 695 that fits within the angled notch 696. The dosing lock extension 622 has a ring shape. The dosing lock is pushed into the locked position by a spring 628. The cam 624 and motor 626 of the dosing lock are positioned on the opposite side of the ring of the dosing lock extension 622 (compared to the angled ledge 695). To release the dosing lock, the motor 626 actuates to turn the cam 624, thereby pushing the dosing lock extension 622 against the force of the spring 628 and moving the angled ledge 695 out of the notch 696.

[0107] The vial lock 630 includes a c-shaped vial lock extension 632, a vial lock cam 634, and a vial lock motor 636. The general orientation of the vial lock 630 is upside down compared to the vial lock 430 of the device 400 shown in FIGS. 9-15 so as to facilitate removal of the vial 500 through the bottom 606 of the device 600. The base 658 fits into the chassis 616 and is held in place by engagement of the vial lock extension 632 with the notch 698 on the base 658. To open the vial lock 630, the motor 636 operates to rotate the cam 634, thereby disengaging the vial lock extension 632 from the notch 698 on the base 658. The vial lock extension 632 is held in the locked position by a spring and is released by operating the vial lock motor 636 to rotate the cam 634 so that the vial lock extension 632 presses against the spring. The base 658 can include a plurality of angled notches for ratcheting the base 658 within the device 600. The ratchet can prevent movement of the base 658 out of the device 600 and allow movement of the base 658 into the device 600.

[0108] Alternatively, the vial lock 630 may include a ring gear lock that encircles the vial 500. The alternative design can increase the reliability of the system and / or reduce manufacturing costs. The motor turns the ring gear lock, thereby disengaging the vial lock while the vial holder / base 658 is in place. When the vial 500 is removed, the ring gear lock returns to the locked position. Next, the base 658 is pushed back to lock in place. The lock clip relies on plastic spring action for the base to move to lock.

[0109] The positions of the dosing lock 620 and the vial lock 630 are detected by measuring the increase in current when the respective cams 624, 634 are rotated to the locking portions by the respective motors 626, 636, in the same manner as described in relation to the device 400 described in FIGS. 9-15.

[0110] The device 600 further includes a sensor (e.g., a limit switch or an optical sensor) for detecting the presence of the vial 500.

[0111] The entire assembly can be made free of exposed screws by a cover 618 that clips onto the chassis 616. Before the cover 618 is clipped on, the functions of the mechanical and electrical components can be assembled and tested on the chassis 616.

[0112] The device 600 includes a mini USB port for charging. Alternatively, the device 600 can include a coil or inductive charging, and / or an alternative charging port such as a USB C, a dedicated charging port, or other charging ports as would be understood by those skilled in the art in accordance with the teachings of the present disclosure.

[0113] FIG. 19 shows a system diagram of an exemplary system including a digital platform 700, a user device 800, and a dispensing device 900. The digital platform 700 and the user device 800 can each include the computing device 200 described herein, its alternatives, and / or its variations as would be recognized and understood by those skilled in the art in accordance with the teachings of the present disclosure. The dispensing device 900 can include any one of the dispensing devices 100, 400, 600 described herein, its alternatives, and / or its variations as would be recognized and understood by those skilled in the art in accordance with the teachings of the present disclosure.

[0114] An authorized user 702 (e.g., a physician) can receive information regarding medication compliance, nozzle position, vial type, patient information, device information, prescription information, dosage information, and dispensing device unauthorized changes via the digital platform 700. The information can be provided as an output 904 of the dispensing device 900. The authorized user 702 can input commands regarding nozzle lock / unlock, vial lock / unlock, and / or biometric load / clear via the digital platform 700. The digital platform can communicate with the dispensing device 900 via an application on the user device 800.

[0115] A user (e.g., a patient) can be authenticated by the dispensing device 900 via the user device 800 and / or the biometric scanner 908. The user device 800 can further receive information regarding the dosing schedule, reminders, and medication compliance from the dispensing device 900.

[0116] The dispensing device 900 can include a motor 926 and a cam 924 positioned to engage a nozzle lock mechanism 922. The motor 926, cam 924, and nozzle lock mechanism 922 can have a structure and / or function similar to that of the dispensing devices 100, 400, 600 described herein for locking the nozzle position to prevent dosing, a variation thereof, or an alternative as would be understood by one of ordinary skill in the art in accordance with the teachings of the present disclosure.

[0117] The dispensing device 900 can include a motor 936 and a cam 934 positioned to engage a vial lock mechanism 932. The motor 936, cam 934, and vial lock mechanism 932 can have a structure and / or function similar to that of the dispensing devices 100, 400, 600 described herein for securing a vial within the dispensing device, a variation thereof, or an alternative as would be understood by one of ordinary skill in the art in accordance with the teachings of the present disclosure.

[0118] The dispensing device 900 can accommodate vials such as vial 500, variations thereof, or alternatives thereto as would be understood by one of ordinary skill in the art in accordance with the teachings of the present disclosure.

[0119] The dispensing device 900 can include a nozzle 960 that can be depressed to dispense a medicament, and features for locking and / or dosing detection as described elsewhere herein, variations thereof, and alternatives thereto as would be understood by one of ordinary skill in the art in accordance with the teachings of the present disclosure can be provided on the dispensing device.

[0120] The dispensing device 900 can include an optical sensor 944 for detecting a partial depression of the nozzle 960, detecting the presence of the vial 500, detecting entry into the dispensing device 900, and / or other functions of the optical sensor as described elsewhere herein, variations thereof, and alternatives thereto as would be understood by one of ordinary skill in the art in accordance with the teachings of the present disclosure.

[0121] The dispensing device 900 can include a gesture sensor 901 (e.g., a micro-motion sensor) for detecting a user-specific movement pattern to be detected when different users handle the device 900.

[0122] FIGS. 20A and 20B are diagrams of alternative handle portions 763 and circuit boards 740 that can be used in place of the handle portion 463 and circuit board 440 of the dispensing device 400 shown in FIGS. 9-16C. The handle portion 763 shown in FIGS. 20A and 20B can include a nozzle 760, an engagement ring 766, and a housing interface 780 having a score 796, which are configured similarly to the corresponding features 460, 466, 480, 496 of the handle portion 463 shown in FIGS. 9-16C. The handle portion 763 and the circuit board 740 can be adapted to function with other dispensing devices disclosed herein, variations thereof, and alternatives thereto as would be understood by one of ordinary skill in the art.

[0123] The handle portion 763 shown in FIGS. 20A and 20B includes a high-contrast graphic image 791 instead of the openings 490, 492, 494 shown in FIGS. 10, 15, 16A, and 16C. The circuit board 740 shown in FIG. 20B includes a sensor 741 positioned to view the high-contrast graphic image 791 and associated hardware and software for operating the sensor 741. When the handle portion 763 is depressed or released, the image 791 moves with the handle portion 763.

[0124] The high-contrast image 791 can be applied to the housing interface 780 by several means. For example, the image 791 can be printed on a sticker, and then the sticker can be affixed to the housing interface 780. The image 791 can be printed directly on the housing interface 780, and / or the image 791 can be overmolded / co-molded with the housing interface 780 in a material that contrasts with the main material of the housing interface 780 in visible light reflection and / or IR light reflection. The image 791 can be sized to approximately 14 millimeters (mm) by 14 mm. The image size can be adjusted to occupy a convenient portion of the housing interface 780, and / or the image size can be adjusted to achieve the sensor resolution according to the teachings herein, as understood by those skilled in the art. For example, the image can have a maximum size limit determined by the area of the housing interface 780 and other geometric coefficients of the dispensing device 400, as well as a minimum size limit determined by the minimum sensor resolution design parameters. The image 791 can include a dark triangle 793 on a light background, or other such images having a change in the amount of dark space relative to light space in the direction of the longitudinal axis L-L. The base of the dark triangle can be aligned on the first end of the image 791, and the base of the light triangle can be aligned on the second end of the image 791, such that the dark and light colors are interleaved. As shown, the base of the dark triangle is at the top of the image 791, and the base of the light triangle is at the bottom of the image 791. However, this orientation can be reversed, by changes in software, such that the base of the light triangle is at the top of the image 791 and the base of the dark triangle is at the bottom of the image 791, as understood by those skilled in the art.

[0125] The sensor 741 can be configured to measure the handle position in a single sample without requiring a comparison with a previous sample. The sensor 741 can be configured to identify the depression length of the nozzle 760 with a high degree of resolution. The resolution can be identified by several means as understood by those skilled in the art. For the purpose of providing the numerical values of the resolution in this specification, the output of the sensor is recorded when the handle portion 763 is moved by a positioner that is numerically controlled over a range of about 5 mm. The recorded output is statistically compared to the control position, and the repeatability and linearity of the sensor output are calculated. Linearity is expressed as the standard deviation of the difference in output from one position to the next when the handle portion 763 is moved in 0.5 mm increments over a range of 5 mm. Repeatability is expressed as the maximum value of the standard deviation of the output samples for each position when the handle portion 763 is moved up and down 5 times over a range of 2 mm and then over a range of 3 mm. The resolution in counts per mm is expressed as the number of sensor output counts between two positions 4 mm apart divided by 4, minus the repeatability, minus the linearity.

[0126] In a preferred example, the sensor can have a resolution of at least about 4 counts per mm and up to more than 500 counts per mm. At about 815 counts per mm, the detected depression can be accurate up to a measurement error of about 64 counts or about 83 micrometers. The sensor 741 can operate continuously at a sample rate of 10 samples per second with an average power consumption of about 47 microwatts at a resolution of about 815 counts per mm. In another example, the sensor can have a resolution of at least about 4 counts per mm and up to about 2350 counts per mm. At 2350 counts per mm, the detected depression can be repeatable with a measurement error of about 20 counts or about 8 micrometers. The sensor 741 can operate continuously at a current of 0.015 milliamperes (mA) at a resolution of 2350 counts per mm. The sensor 741 can operate continuously at a current of about 0.004 mA at a resolution of about 500 counts per mm.

[0127] The sensor 741 and the image 791 can be of low profile. Preferably, the main board of the circuit board 740 can be at a distance D1 of about 2.5 millimeters from the housing interface 780. The sensor 741 is separate from the housing interface 780, and by ensuring that the graphic image 791 does not come into contact with the sensor 741, damage to neither the graphic image 791 nor the sensor 741 can occur due to the depression of the housing interface 780. The sensor 741 can be non-responsive to external fields and influences such as sunlight and magnets. The sensor 741 can be robust against manufacturing tolerances and drift. The sensor 741 can be configured to have a high sample rate such that it can detect rapid partial dosing. The sensor 741 can be configured to detect the presence of a vial. The sensor 741 and the circuit board 740 can be configured to perform an automated calibration procedure when the handle portion 763 and the vial 500 are inserted into the housing 402. The sensor 741 may have only a single sensor or may have a second sensor for calibration and / or redundancy. The sensor 741 can operate without using a lens or other such optical features.

[0128] The sensor 741 can be configured to detect the reflectivity of the image 791. The sensor 741 includes an infrared (IR) proximity sensor and preferably also includes a wide-angle IR light-emitting diode (LED). The IR LED can be positioned to illuminate the image 791. The sensor 741 can be configured to detect changes in the IR reflectivity presented to the sensor 741 as the image 791 moves. The sensor 741 can be configured to detect the presence of the vial 500 using IR distance sensing.

[0129] Generally, IR proximity sensors are currently used in several applications such as autofocus, gesture recognition, etc. to detect movement or measure distance. When measuring distance, a beam of IR light is emitted, and the IR proximity sensor measures the intensity of the IR light reflected from an object to the detector. Here, the intensity is inversely proportional to the distance from the object to the detector. To achieve good performance, these sensors use several techniques to provide a very low power and large dynamic measurement range in the presence of strong interference (e.g., sunlight). IR proximity sensors can include circuits, materials, and techniques known in the art to result in non - responsiveness to external fields and influences such as sunlight, magnets, etc.

[0130] IR proximity sensors are typically designed to detect a target positioned at a distance much greater than the separation D1 between the sensor 741 and the image 791 as shown in Figure 20B. Thus, a typical IR proximity sensor includes a narrow - beam IR emitter spaced from the detector. The narrow beam is desirable to achieve accurate measurements at greater distances. The sensor 741 in the distribution device 400 preferably includes a wide - angle IR light source (e.g., an LED) used instead of or in addition to the narrow - beam IR emitter. For example, a narrow - beam IR emitter can be used to identify the presence of the vial 500, while a wide - angle IR light source can be used to identify the movement of the image 791.

[0131] The image 791 preferably has high contrast with respect to IR reflectivity. The image 791 can include, as non - limiting examples, black polyvinyl chloride (PVC) against white plastic and / or a black laser - printed image on white paper. A black thermal - printed image on white paper may have significantly lower contrast with respect to IR reflectivity compared to black polyvinyl chloride (PVC) against white plastic and / or a black laser - printed image on white paper.

[0132] Additionally or alternatively, sensor 741 can include a visible light sensor and a visible light source for detecting depression of the handle portion 763. The visible light sensor can replace the IR proximity sensor for detecting depression of the handle portion 763, and / or can be used in addition to the IR proximity sensor as a redundant and / or calibration sensor for depression of the handle portion 763.

[0133] Sensor 741 can be configured to perform a line scan of image 791, which changes as the handle portion 763 moves. Sensor 741 can have a short dimension in the direction of the longitudinal axis L-L and can have a long dimension perpendicular to the longitudinal axis L-L, where the long dimension is substantially greater than the short dimension.

[0134] FIG. 21 is a diagram of an image 791a configured to provide reflectivity to a rotational sensor. Using the principles described with respect to sensor 741 and image 791 described with respect to FIGS. 20A and 20B in other applications (i.e., not limited to dispensing device 400), a non-contact high-resolution sensor can be provided for identifying the position and / or angular rotation of component parts within a mechanical device or system. Exemplary image 791a can include a tapered arcuate band having a wide base as a first rotation angle and a tapered end at a second rotation angle. Measuring the angle counterclockwise, FIG. 21 shows a tapered arcuate dark band having a base at zero degrees and a tapered end at 180 degrees, and an interleaved tapered arcuate light band having a wide base at 180 degrees and a tapered end at zero degrees. Image 791a can have a shape geometrically related to a circle, such as a sector, an annulus, an annulus sector, etc. Image 791 can have a center point defined by the trajectory of the tapered arcuate band. Image 791a and sensor 741 can be fixed relative to each other at the center point of image 791a. At least one of sensor 741 and image 791a can be configured to rotate about the center point, whereby sensor 741 moves to trace the arc of the arcuate band and / or image 791a moves to move the arc of the arcuate band across sensor 741. The resolution of sensor 741 can be specified in counts per unit angle (e.g., degrees or radians).

[0135] Further alternative means for detecting depression of the handle portion are also considered. The detection means can be combined for redundancy and / or calibration in the dispensing device. A linear magnetic field sensor can be positioned to detect the movement of the magnetic dipole of the handle portion, and the magnetic field strength and direction in such a sensor change as the handle portion moves. A capacitive sensor can include a metal plate on the circuit board and a metal plate on the handle portion, whereby an electric field having a magnitude proportional to the overlap of the plates is coupled between the sensor plates, and the overlap of the plates changes as the handle portion moves relative to the circuit board. A resistive sensor can include a potentiometer positioned on the circuit board having a knob that rotates relative to ribs on the handle portion when the handle portion moves relative to the circuit board, thereby changing the resistance of the potentiometer. One or more microswitches having rockers that engage mechanical ribs on the handle can be positioned on the circuit board when the handle portion is moved relative to the circuit board and the microswitch is toggled between open and closed based on depression of the handle portion. An optical interruption sensor can include an optical sensor positioned to detect light passing through an opening on the handle portion and a light source positioned to provide light through the opening in the handle portion, and the opening can include a horizontal rib or a modulated scale. A magnetic field sensor can be positioned to detect the magnetic scale of the handle portion such that the magnetic field in the sensor alternates as the scale moves with the handle portion. A motion tracking integrated circuit can be positioned to view an image on the handle such that the motion tracking integrated circuit detects movement of the image as the handle moves relative to the motion tracking integrated circuit. A color sensor can be positioned to view an image having a color gradient on the handle portion illuminated by a white light source such that the color of the light reflected to the color sensor changes as the image moves with the handle portion.The image on the handle portion can have a black-and-white border such that the total amount of light reflected from the image to the sensor changes with the position of the handle portion, and the sensor on the circuit board can include one or more of an IR light reflection sensor, an IR proximity sensor, and an ambient light sensor.

[0136] The present invention has been shown and described with reference to specific exemplary embodiments, but it will be understood by those skilled in the art that various detailed changes can be made without departing from the spirit and scope of the present invention and without limiting the invention claimed herein. Further, if an exemplary embodiment is described with reference to a specific number of elements, it will be understood that the exemplary embodiment can be implemented using either fewer or more than the specific number of elements. It should be noted that the present invention includes the following aspects. [Aspect 1] A nasal spray device, comprising a conical nozzle portion, a housing interface configured to be attached to a vial, and a nozzle provided with a graphic image positioned on an outer surface of the housing interface; a housing comprising a chamber sized to receive the vial, an opening communicating with the chamber, and a sensor; wherein the housing interface is positioned within the opening and configured to slide through the opening when the nozzle moves relative to the housing, the sensor is configured to detect movement of the graphic image when the nozzle moves relative to the housing. The nasal spray device. [Aspect 2] The nasal spray device according to Aspect 1, wherein the graphic image includes a printed image on a label attached to the outer surface of the housing interface. [Aspect 3] The nasal spray device according to Aspect 1 or 2, wherein the graphic image includes a print directly applied to the outer surface of the housing interface. [Aspect 4] The nasal spray device according to any one of Aspects 1 to 3, wherein the graphic image comprises a material composition separate from most of the housing interface, is overmolded, and / or is co-molded with the housing interface. [Aspect 5] The nasal spray device according to any one of Aspects 1 to 4, wherein the graphic image has high contrast with respect to infrared light reflectance. [Aspect 6] The nasal spray device according to any one of Aspects 1 to 5, wherein the graphic image includes interleaved dark and light triangles, a base of the dark triangle is aligned on a first end of the graphic image, a base of the light triangle is aligned on a second end of the graphic image, and the first end and the second end of the graphic image are aligned in a longitudinal direction. [Aspect 7] The nasal spray device according to any one of Aspects 1 to 6, wherein the sensor is configured to measure the position of the nozzle with respect to the housing in a single sample without requiring comparison with a previous sample. [Aspect 8] The nasal spray device according to any one of Aspects 1 to 7, wherein the sensor is configured to measure the position of the nozzle with respect to the housing with a measurement error of about 83 micrometers. [Aspect 9] The nasal spray device according to any one of Aspects 1 to 8, wherein the sensor is configured with a measurement resolution of about 4 counts per millimeter (mm) to about 815 counts per mm. [Aspect 10] The nasal spray device according to Aspect 9, wherein the sensor is configured with a measurement resolution of about 500 counts per mm. [Aspect 11] The nasal spray device according to Aspect 10, wherein the sensor is configured to operate continuously at 10 samples per second at an average power of about 47 microwatts with a measurement resolution of about 500 counts per mm. [Aspect 12] The housing further includes a printed circuit board to which the sensor is attached, The nasal spray device according to any one of Aspects 1 to 11, wherein the main board of the printed circuit board is positioned at a distance of about 2.5 millimeters from the housing interface. [Aspect 13] The sensor is further configured to detect the presence of the vial in the chamber, The nasal spray device according to any one of Aspects 1 to 12, wherein the sensor is further configured for automatic calibration in response to insertion of the vial into the chamber. [Aspect 14] The sensor includes an IR proximity sensor configured to detect a change in infrared (IR) reflectance from the graphic image when the nozzle moves with respect to the housing, The nasal spray device according to any one of Aspects 1 to 13, wherein the sensor includes a wide-angle IR light-emitting diode (LED). [Aspect 15] The nasal spray device according to Aspect 14, wherein the graphic image includes ink laser-printed on paper and / or polyvinyl chloride on plastic. [Aspect 16] The nasal spray device according to Aspect 14 or 15, wherein the IR proximity sensor is configured to detect the presence of the vial in the chamber by distance detection. [Aspect 17] The nasal spray device according to any one of Aspects 1 to 16, wherein the sensor includes a visible light sensor and a visible light source. [Aspect 18] The nasal spray device according to any one of Aspects 1 to 17, wherein the sensor is configured to perform line scanning of the graphic image. [Aspect 19] A nasal spray device comprising: a nozzle including a conical nozzle portion and a housing interface configured to be attached to a vial; a housing including a chamber sized to receive the vial, an opening communicating with the chamber, and a sensor; wherein: the housing interface is positioned within the opening and configured to slide through the opening when the nozzle moves relative to the housing; the sensor is configured to detect movement of the housing interface when the nozzle moves relative to the housing; the sensor includes at least one of a magnetic field sensor, a capacitance sensor, a resistance sensor, a microswitch, a motion tracking integrated circuit, and a color sensor. [Aspect 20] An infrared (IR) rotational sensor assembly comprising: an image including tapered arcuate dark bands interleaved with tapered arcuate light bands, each of the tapered arcuate dark bands having a low IR reflectivity and each of the tapered arcuate light bands having a high IR reflectivity; an IR detector configured to rotate about a center point of the image, the IR detector being configured to remain aligned with the tapered arcuate dark bands and the tapered arcuate light bands as the IR detector rotates about the center point; wherein the IR rotational sensor assembly includes the image and the IR detector.

Explanation of Symbols

[0137] 100 Distribution Device 102 Housing 104 First closed end 104a Surface 106 Second closed end 106a Base plate 108 Nozzle 110 Recess 112 Display, display screen 114 First part 116 Second part 118 Liquid container 120 Pump, pump assembly 122 Channel 124 Solenoid 126 Printed circuit board 128 Battery 130 Signal LED 132 Lens 134 Biosensor 136 Photocell 138 Drug sensor 140 Tactile switch 142 Real-time clock, real-time clock chip 200 Computing device 242 Cam 300 Motor assembly 302 Motor 304 First gear 306 Opening 308 Internal gear 310 Central lock 312 Key groove 314 Shaft 316 Key 318 Aperture 320 Bottom surface 322 Second gear 324 Disk 326 Notch 328 L-shaped flange 330 Upper surface 400 Dispensing device 402 Housing 404 First upper end 404a First surface, first upper surface 406 Second lower end 406b Second bottom surface 408 Biosensor 410 Finger cover 412 Opening 413 Key extension 414 Chamber, chamber cavity 415 Locking part 416 Chassis 417 Locking part 418 Cover 419 Outlet 420 Medication lock 422 Sliding extension 423 Bump 424 Cam 425 Extension 426 Motor 427 Lock cover 428 Spring 430 Vial lock 432 Sliding extension 433 Bump 434 Cam 435 Extension 436 Motor 437 Lock cover 438 Spring 440 Circuit board 442 Optical sensor 444 Optical sensor, central sensor 446 Optical sensor 448 Battery 450 Induction coil 451 Upper cover 452 LED board 453 Light guide 454 Upper ring 455 Screw 456 Scan nest 457 Co-molded ring 460 Disposable nozzle, dedicated nozzle 461 Nozzle cap 462 Conical part 463 Handle part 463a Upper part Lower part of 463b 464 Fluid passage 465 Clip 466 Engagement ring 467 Cradle 468 Upper surface 470 Bottom surface 472 Dispensing end 474 Base end 476 Retaining ring 478 Spring 480 Housing interface 481 Flexible hook 482 Outer surface 484 Upper end 486 Lower end 488 Passage 490 Visual feature, vial lock opening 492 Visual feature, opening 494 Visual feature, opening 496 Score mark 497 Upper ledge 498 Vial lock opening 499 Lower ledge 500 Nasal sprayer, pharmaceutical vial, nasal spray device 502 Liquid container 504 Sprayer 508 Vial nozzle 510 Push-down tab 600 Dispensing device 606 Bottom 608 Biosensor 610 Finger cover 616 Chassis 618 Cover 620 Dosing lock 622 Sliding dosing lock extension 624 Dosing lock cam 626 Dosing lock motor 628 Spring 630 Vial lock 632 C-shaped vial lock extension 634 Vial lock cam 636 Vial lock motor 640 Circuit board 648 Battery 651 Upper cover 652 LED board 653 Light guide 654 Upper rim 657 Cover co - molding 658 Base 660 Nozzle 663 Handle part 678 Spring 680 Housing interface 682 Outer surface 695 Angled ledge 696 Notch 698 Notch 700 Digital platform 702 User 740 Circuit board 741 Sensor 760 Nozzle 763 Handle part 766 Engagement ring 780 Housing interface 791 High - contrast graphic image 793 Triangle 796 Notch 800 User device 900 Dispensing device 901 Gesture sensor 904 Output 908 Bioscanner 922 Nozzle lock mechanism 924 Cam 926 Motor 932 Vial lock mechanism 934 Cam 936 Motor 944 Optical sensor 960 Nozzle

Claims

Claim 1 A nasal spray device comprising a nozzle having a conical nozzle portion, a housing interface configured to be attached to a vial, and a graphic image positioned on an outer surface of the housing interface; a housing having a chamber sized to receive the vial, an opening in communication with the chamber, and a sensor; wherein the housing interface is positioned within the opening and configured to slide through the opening as the nozzle moves relative to the housing; the sensor is configured to detect movement of the graphic image as the nozzle moves relative to the housing. A nasal spray device. Claim 2 The nasal spray device according to claim 1, wherein the graphic image includes a printed image on a label attached to the outer surface of the housing interface. Claim 3 The nasal spray device according to claim 1 or 2, wherein the graphic image includes a print directly applied to the outer surface of the housing interface. Claim 4 The nasal spray device according to any one of claims 1 to 3, wherein the graphic image comprises a material composition separate from a majority of the housing interface, is overmolded, and / or is co-molded with the housing interface. Claim 5 The nasal spray device according to any one of claims 1 to 4, wherein the graphic image has high contrast with respect to infrared light reflectance. Claim 6 The nasal spray device according to any one of claims 1 to 5, wherein the graphic image includes interleaved dark and light triangles, a base of the dark triangle is aligned on a first end of the graphic image, a base of the light triangle is aligned on a second end of the graphic image, and the first and second ends of the graphic image are longitudinally aligned. Claim 7 The nasal spray device according to any one of claims 1 to 6, wherein the sensor is configured to measure the position of the nozzle relative to the housing in a single sample without requiring a comparison with a previous sample. Claim 8 The sensor is configured to measure the position of the nozzle relative to the housing with a measurement error of about 83 micrometers, the nasal spray device according to any one of claims 1 to 7.

9. The sensor is configured with a measurement resolution of about 4 counts per millimeter (mm) to about 815 counts per mm, the nasal spray device according to any one of claims 1 to 8.

10. The sensor is configured with a measurement resolution of about 500 counts per mm, the nasal spray device according to claim 9.

11. The sensor is configured to operate continuously at 10 samples per second at an average power of about 47 microwatts with a measurement resolution of about 500 counts per mm, the nasal spray device according to claim 10.

12. The housing further comprises a printed circuit board to which the sensor is attached, The main board of the printed circuit board is positioned at a distance of about 2.5 millimeters from the housing interface, the nasal spray device according to any one of claims 1 to 11.

13. The sensor is further configured to detect the presence of the vial within the chamber, The sensor is further configured for automatic calibration in response to the insertion of the vial into the chamber, the nasal spray device according to any one of claims 1 to 12.

14. The sensor includes an IR proximity sensor configured to detect a change in infrared (IR) reflectance from the graphic image when the nozzle moves relative to the housing, The sensor includes a wide-angle IR light-emitting diode (LED), the nasal spray device according to any one of claims 1 to 13.

15. The graphic image includes ink laser-printed on paper and / or polyvinyl chloride on plastic, the nasal spray device according to claim 14.

16. The IR proximity sensor is configured to detect the presence of the vial within the chamber by distance sensing, the nasal spray device according to claim 14 or 15.

17. The sensor includes a visible light sensor and a visible light source, the nasal spray device according to any one of claims 1 to 16.

18. The sensor is configured to perform a line scan of the graphic image, the nasal spray device according to any one of claims 1 to 17.

19. A nasal spray device, A nozzle comprising a conical nozzle portion and a housing interface configured to be attached to a vial, A housing comprising a chamber sized to receive the vial, an opening in communication with the chamber, and a sensor, Comprising, The housing interface is positioned within the opening and is configured to slide through the opening when the nozzle moves relative to the housing, The sensor is configured to detect movement of the housing interface when the nozzle moves relative to the housing, The sensor includes at least one of the group consisting of a magnetic field sensor, a capacitance sensor, a resistance sensor, a microswitch, a motion tracking integrated circuit, and a color sensor, a nasal spray device.

Images