KR20240005793A - Systems and methods for detecting use of controlled medical treatment devices - Google Patents

Abstract

The nasal spray device may include a housing with a sensor and a nozzle with a housing interface with a graphical image. The sensor may be configured to detect movement of the graphical image as the nozzle moves relative to the housing, for example during administration of medication from a nasal spray device. The sensor may include an infrared proximity sensor that detects infrared reflectance in the graphic image. The infrared proximity sensor can also be used to detect insertion of the vial into the housing by measuring the distance to the surface of the vial within the housing.

Description

Systems and methods for detecting use of controlled medical treatment devices

The present invention relates to a system and method for controlling the distribution of drugs, and more specifically, to a system and method for dispensing drugs through a time-controlled device linked to a web platform.

Conventional personal drug dispensing devices, such as intranasal spray devices, are often used effectively to deliver atomized drugs. Traditional intranasal spray devices consist of a pump with an elongated nozzle that dispenses atomized liquid as the liquid is sprayed through the nozzle and out of a delivery orifice. The generated mist is inhaled and efficiently absorbed through the tissues to provide effective treatment.

Intranasal spray devices have been utilized to deliver medications for ailments ranging from allergies, pain relief and depression. For conditions such as pain relief and depression, there is a high risk of abuse associated with medications delivered within the device due to the addictive nature of the drugs used to treat those conditions. For example, Ketamine has been shown to be very effective in treating serious conditions such as bipolar depression. However, due to the addictive nature of drugs such as ketamine, health care providers are hesitant to administer or prescribe it for home use. Health care providers are often concerned about patients abusing or misusing medications, abuse by people other than the patient, and the theft and/or sale of medications.

Abuse and misuse are due not only to the addictive nature of the drug, but also to the drug's effectiveness in alleviating the patient's condition. Patients may be induced to use more than the prescribed dose due to the relief the drug provides. Therefore, patients who need such drugs may receive only small doses or supplies each time they visit their health care provider. As a result, some patients need to visit their health care provider frequently, such as several times a week. Requiring multiple visits to a health care provider is not only inconvenient, but can also be a barrier to accessing medications for people who cannot afford burdensome transportation costs or have to spend long periods of time away from work.

Systems and methods are provided for dispensing medication with a locking dispensing device. The dispensing device can be shaped to form an exoskeleton around the vial. The dispensing device may include one or more locking mechanisms to prevent removal of the vial and/or administration of a dose. The system may configure the dispensing device to configure parameters of the dispensing device (e.g., timeout, tamper detection, improper use, biometric input, user authentication) for engaging and/or disengaging the dispensing device and the locking mechanism. It may include a computing device that can be connected to.

The dispensing device may include a nozzle and a housing, which may be integrated or separate components that may be slidably engaged with each other to form an exoskeleton around the vial. The nozzle may include a housing interface configured to slidely couple the nozzle to the housing.

The dispensing device may include a vial lock that can be locked to prevent removal of the vial from the dispensing device and that can be unlocked to allow removal of the dispensing device. In some examples, the vial lock further includes stops to limit movement of the nozzle relative to the housing (e.g., establish a fully extended position of the nozzle and/or a fully depressed position of the nozzle). It can be included. In an example where the nozzle is removable 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.

The dispensing device may include a dose lock that can be locked to prevent movement of the nozzle relative to the housing, thereby preventing drug administration. The dose lock is unlocked to allow the nozzle to be pressed into or extended out of the housing to administer medication. In instances where the nozzle is removable from the housing, the dose lock may further inhibit separation of the nozzle from the housing and/or removal of the vial from the device when locked.

The dispensing device may include a sensor configured to detect partial depression of the nozzle and an electrical circuit configured to lock the dose lock in response to a signal from the sensor. The sensor may include an optical sensor positioned to view movement of the nozzle relative to the housing.

In instances where the nozzle is removable from the housing, the nozzle may function to deliver drug with the vial without the housing. The housing may include the dose lock and the vial lock. The nozzle may include a feature that allows the dose lock and/or the vial lock to engage and lock. The housing may include sensors to detect movement of the nozzle. Sensors and features of the nozzle may be arranged or configured to enable the device to detect partial depression of the nozzle.

The invention will be more fully understood and appreciated by reading the following detailed description in conjunction with the accompanying drawings.
Figure 1 is a perspective view of one embodiment of a system according to the invention.
Figure 2 is a schematic cross-sectional view of one embodiment of the system in an unlocked position taken along line A;
Figure 3A is a schematic cross-sectional view of one embodiment of the system in a locked position taken along line A;
Figure 3B is a schematic cross-sectional view of one embodiment of the system in a locked position taken along line B.
Figure 4 is a diagram showing an embodiment of the method according to the present invention.
Figure 5 is a diagram showing an embodiment of the method according to the present invention.
Figure 6 is a diagram showing an embodiment of the method according to the present invention.
Figure 7A is a top perspective view of an embodiment of the motor assembly in a locked position.
Figure 7B is a side perspective view of an embodiment of the motor assembly in an unlocked position.
Figure 7C is a top view of an embodiment of the motor assembly in the unlocked position.
Figure 8A is a side perspective view of an embodiment of a first portion and a second portion of a housing with a motor assembly;
Figure 8B is another side perspective view of an embodiment of the first and second portions of the housing in an unlocked position;
Figure 8C is a top perspective view of an embodiment of the first and second portions of the housing in a locked position.
Figure 9 is a profile view of another embodiment of the dispensing device according to the invention.
Figure 10 is a cross-sectional view of a nozzle and a vial according to the present invention.
Figures 11A and 11B are orthogonal profile views of the nozzle and vial shown in Figure 10 in accordance with the present invention.
Figure 12 is a profile view of the vial, retaining ring and spring according to the invention.
Figure 13 is a cross-sectional view of the dispensing device shown in Figure 9 and oriented with components removed to visualize the dose lock and vial lock according to the present invention.
Figure 14A is a top view of a housing according to the present invention.
Figure 14B is a cross-sectional view of the housing oriented in Figure 14A in accordance with the present invention.
Figure 15 is an exploded view of the dispensing device shown in Figure 9 according to the invention.
Figures 16A-16C illustrate alternative handle portions of the nozzle of the dispensing device shown in Figure 9 in accordance with the present invention.
Figure 17 is an exploded view of another embodiment of the dispensing device according to the invention.
Figure 18A is a cross-sectional view of the dispensing device according to the invention shown in Figure 17 taken along plane A;
Figure 18B is a cross-sectional view of the dispensing device according to the invention shown in Figure 17 taken along plane B;
Figure 19 is a block diagram of a system according to the present invention.
Figure 20A is a side view of an alternative handle portion and vial according to the present invention.
FIG. 20B is an orthogonal side view of the vial and the handle portion of FIG. 20A with an alternative circuit board in accordance with the present invention.
21 is a diagram illustrating an image configured to provide reflectivity to a rotation sensor according to the present invention.

Referring to the drawings, the present invention may be a system, method and/or computer program product. A computer program product may include a non-transitory computer-readable storage medium (or media) having computer-readable program instructions for causing a processor to perform aspects of the invention.

A computer-readable storage medium may be a tangible device capable of maintaining and storing instructions used by an instruction execution device. A computer-readable storage medium may 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 thereof. A non-exhaustive list of more specific examples of computer-readable storage media include portable computer diskettes, hard disks, random access memory (RAM), read-only memory (ROM), erasable programmable ROM (EPROM), or flash memory, static random access memory (SRAM). Mechanically encoded devices and tactics, such as RAM, portable CD-ROM, DVD (Digital Versatile Disk), memory stick, floppy disk, punch-card, or raised structures with grooves where commands are written. Includes any suitable combination of the same. As used herein, computer-readable storage media refers to information that is transient in itself, such as radio waves or other freely propagating electromagnetic waves, electromagnetic waves propagating through waveguides, or other transmission media (e.g., fiber optic cables) or electrical signals transmitted through wires. It should not be interpreted as a signal.

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

Computer-readable program instructions for performing the operations of the present invention include assembler instructions, instruction set architecture (ISA) instructions, machine instructions, machine-dependent instructions, microcode, firmware instructions, state setup data, or smalltalk, C++, etc. It may be source code or object code written in a combination of one or more programming languages, including an object-oriented programming language and a traditional procedural programming language, such as the “C” programming language or a similar programming language. The computer-readable program instructions may be executed entirely on the user's computer, partially on the user's computer, as a standalone software package, partially on the user's computer, partially on a remote computer, or entirely on a remote computer or server. In the latter case, the remote computer is connected to your computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or to an external computer (for example, over the Internet using an Internet service provider). can be connected In one embodiment, electronic circuitry, including, for example, programmable logic circuitry, field-programmable gate arrays (FPGAs), or programmable logic arrays (PLAs), is used to personalize the electronic circuitry to perform aspects of the invention. The computer-readable program instructions can be executed by utilizing the state information of the computer-readable program instructions.

Aspects of the present invention will be described with reference to flowcharts and/or block diagrams of methods, devices (systems), and computer program products according to embodiments of the present invention. It will be understood that each block of the flowchart and/or block diagram, and combinations of blocks in the flowchart example and/or block diagram, may be implemented by computer readable program instructions.

These computer readable program instructions are such that instructions executed through a processor of a computer or other programmable device create a means for implementing the functions/acts specified in the block or blocks of the flow diagram and/or block diagram, such as a general purpose computer, special purpose computer. Or it may be provided to a processor of another programmable data processing device. Such computer-readable program instructions may also be stored in a computer-readable storage medium that can instruct a computer, programmable data processing device, and/or other device to function in a particular manner, such that a computer-readable storage medium having the instructions stored therein may be stored therein. Storage media includes blocks of flowcharts and/or block diagrams or articles of manufacture containing instructions that implement functions/actions specified in the blocks.

The computer-readable program instructions may also be loaded onto a computer, other programmable data processing device, or other device to cause a series of operational steps to be performed on the computer, other programmable device, or other device to produce a computer-implemented process, the computer, Causes other programmable devices or instructions executing on other devices to implement the functions/behaviors specified in the flowchart and/or block diagram block or blocks.

The flow diagrams and block diagrams in the drawings illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products in accordance with various embodiments of the invention. In this regard, each block of a flowchart or block diagram may represent a module, segment, or portion of instructions containing one or more executable instructions to implement specified logic function(s). In some alternative implementations, the functions mentioned in the blocks may occur outside of the order mentioned in the figures. For example, two blocks shown in succession may in fact be executed substantially simultaneously, or the blocks may sometimes be executed in reverse order depending on the functions involved. Each block in a block diagram and/or flowchart example, and a combination of blocks in a block diagram and/or flowchart example, is implemented by special-purpose hardware-based systems that perform a specific function or operation or combinations of special-purpose hardware and computer instructions. It can be.

Referring back to the drawings (like reference numbers refer to like parts throughout), Figure 1 shows a perspective view of an embodiment of a system according to the invention. 1 shows an embodiment of a system including a dispensing device 100 and a computing device 200. Computing device 200 may be a smartphone, portable tablet, laptop computer, and other similar devices. Figure 1 also shows external components of an embodiment of dispensing device 100. Dispensing device 100 includes a cylindrical housing 102 having a first closed end 104 and a second closed end 106. Nozzle 108 extends vertically from surface 104a of first closed end 104. The second closed end 106 may further include a base plate 106a fixed to the housing 102 with fasteners such as star screws, which facilitates manipulating the housing 102. It can be prevented. Other fasteners such as magnetic fasteners, custom “keyed” screws, or similar fasteners are also considered. Housing 102 further includes a recess 110 having a display screen 112 therein. The display screen may be a panel display, for example a monochrome OLED, a graphic display or other LED display.

2, a schematic cross-sectional view taken along line A of an embodiment of the system in an unlocked position is shown. Figure 2 shows the internal components of the dispensing device 100 in an unlocked position with the nozzle 108 depressed. Housing 102 of 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.

In the depicted embodiment, the second portion 116 of the housing 102 is connected to the second closed end 106 or base plate 106a and provides a base for the dispensing device 100. The second portion 116 accommodates a liquid container 118 configured to store a liquid drug composition. In the depicted embodiment, liquid container 118 is cylindrical to provide an efficient fit within similarly cylindrical housing 102. An example of a cylindrical liquid container 118 is a threaded stock vial.

To provide access to the drug contents of liquid container 118, liquid container 118 includes a pump assembly 120. In the embodiment shown in FIG. 2 , pump 120 is centrally located within liquid container 118 . Pump assembly 120 is constructed and operates substantially like a standard pump assembly used in conventional intranasal spray devices. As pressure is applied to the nozzle 108 toward the surface 104a of the first closed end 104, the pump assembly 120 forces the liquid medical composition stored within the liquid container 118 into the channel of the nozzle 108. 122) expels the liquid medical composition from the dispensing device 100. Accordingly, in the unlocked position, the liquid medical composition can be freely discharged from the dispensing device 100.

3A and 3B, schematic cross-sectional views of a system embodiment of the locked position are shown taken along lines A and B, respectively. In the depicted embodiment, first portion 114 of housing 102 further includes a solenoid 124 locking mechanism therein. Solenoid 124 operates perpendicular to the movement of pump assembly 120. In one embodiment, when solenoid 124 is activated, it moves into the path of nozzle 108 and blocks total movement of nozzle 108 toward surface 104a of first closed end 104 and pump assembly 120 prevents the liquid medical composition from dispensing device 100 . Solenoid 124 is shown in the unlocked position in Figure 2 and in the locked position in Figures 3A and 3B. In alternative embodiments, solenoid 124 may include an attachment, such as a U-clip, that blocks the path of nozzle 108 and impedes movement of pump assembly 120.

3A and 3B, in the embodiment shown, solenoid 124 is activated in response to an electrical signal transmitted from a processor, such as printed circuit board 126. 3A and 3B, printed circuit board 126 is positioned within second portion 116 of housing 102 toward second closed end 106. The printed circuit board 126 is operably connected at the second closed end 106 to a battery 128, also located within the second portion 116, thereby supplying power. Battery 128 may be a rechargeable lithium ion battery or similar type of power source.

In an alternative embodiment, the locking mechanism is a motor assembly 300. 7A-8C show various views of an embodiment of a motor assembly 300 locking mechanism. Referring first to Figure 7A, a top perspective view of the motor assembly 300 is shown in the locked position. Motor assembly 300 includes a motor 302 coupled to a first gear 304 located within an opening 306 of an internal gear wheel 308. The internal gear wheel 308 includes a central lock 310 with a keyway 312 extending therethrough. Similar to the embodiment where the locking mechanism is a solenoid 125 (FIGS. 3A and 3B), the motor assembly 300 impedes or blocks the movement of the pump assembly 120. 7A, shaft 314 of pump assembly 120 extends through central lock 310 of internal gear wheel 308. To facilitate locking, there are one or more keys 316 protruding from the shaft 314 of the pump assembly 120. The key 316 is configured to slide or fit into the key way 312 of the central lock 310. In the embodiment shown in Figure 7A, the key 316 is placed in the central lock 310 and prevented from sliding into the key way 312. Accordingly, the nozzle 108 attached to the pump assembly 120 cannot be compressed if the key 316 is not aligned with the key way 312.

Referring now to FIGS. 7B and 7C, side perspective and top views of the motor assembly 300 in an unlocked position are shown. From the locked position shown in Figure 7B, motor 302 is activated by an electrical signal from printed circuit board 126, which rotates gear 304, thereby rotating internal gear wheel 308. The opening 306 of the inner gear wheel 308 limits the rotation of the inner gear wheel 308 since it can only rotate in one direction until the inner gear wheel 308 engages the gear 304. As the internal gear wheel 308 rotates, the central lock 310 and keyway 312 also rotate. Internal gear wheel 308 rotates until it is in the unlocked position as shown in Figure 7B. In the unlocked position, key 316 of shaft 314 of pump assembly 120 is aligned with key way 312 extending through lock 310. When the motor assembly 300 is in the unlocked position, the nozzle 108 can be compressed. Compression of the nozzle 108 causes the key 316 on the shaft 314 of the pump assembly 120 to slide into the key way 312 of the lock 310, as shown in FIG. 7C. Once the nozzle 108 is released, the key 316 on the shaft 314 can be slid out of the key way 312 and the internal gear wheel 308 can be rotated back to the locked position shown in Figure 7A.

Referring now to Figures 8A-8C, various perspective views of a first portion 114 and a second portion 116 of an embodiment of a housing 102 having a motor assembly 300 are shown. In the depicted embodiment, first portion 114 of housing 102 includes pump assembly 120, printed circuit board 126, and battery 128 (not shown), and second portion 114 of housing 102 Portion 115 includes a liquid container 118 (not shown). Referring first to Figure 8B, there is a side view of the first portion 114 of housing 102 and the second portion 116 of housing 102 in an unlocked position. The first portion 114 of the housing 102 has an aperture 318 along the perimeter of the bottom surface 320 . A disk 324 stacked on top of the bottom surface 320 of the first portion 114 of the housing 102 has a cutout 326 along the outer circumference of the disk 324. Cutout 326 is configured to align with hole 318 in bottom surface 320 of first portion 114 . 8B, the motor 302 of the motor assembly 300 includes a second gear 322 on the side of the motor 302 opposite the first gear 304. The second gear 322 is used to rotate the disk 324 on the bottom surface 320 of the first portion 114.

Referring now to FIG. 8A, second portion 116 of housing 102 includes a plurality of L-shaped flanges 328 extending from an upper surface 330 of second portion 116. The L-shaped flange 328 is configured to fit through a hole 318 in the bottom surface 320 of the first portion 114 and a cutout 326 in the disk 324. In the unlocked position shown in Figure 8B, the L-shaped flange 328 is aligned with the hole 318 in the bottom surface 320 of the first portion 114 and the cutout 326 in the disk 324. . Accordingly, the second portion 116 may be pulled and removed from the first portion 114 of the housing 102.

To reach the locked position shown in Figure 8C, motor 302 rotates second gear 322 to rotate disk 324 upon receiving an electrical signal from printed circuit board 126. Disk 324 rotates so that cutout 326 is no longer aligned with L-shaped flange 328. Therefore, the L-shaped flange 328 and consequently the second portion 116 of the housing 102 cannot be removed from the first portion 114. In some embodiments, disk 324 is spring loaded such that the locked position is the default position of disk 324.

The circuitry described above to activate the locking mechanism may also be connected to one or more signal LEDs 130 on housing 102 as shown in FIG. 1 . In one embodiment, signal LED 130 illuminates when solenoid 124 is activated and dispensing device 100 is in the locked position. In an alternative embodiment, signal LED 130 illuminates a color such as red when solenoid 124 is activated and dispensing device 100 is in the locked position, and solenoid 124 is deactivated or otherwise deactivated and dispensing device 100 is in the locked position. Device 100 may illuminate green when it is in the unlocked position.

The circuit is also connected to the screen 112 in the recess 110 of the housing 102 to provide power to the screen 112. In the embodiment shown in FIGS. 2 and 3A, recess 110 is surrounded by lens 132. Lens 132 protects screen 112 from liquids, debris, and other contaminants while allowing the user to view screen 112 clearly. In the depicted embodiment, lens 132 is flush with housing 102 to allow a user to easily manipulate dispensing device 100. In one embodiment, lens 132 may include a biometric sensor therein. In an alternative embodiment, such as that shown in FIG. 1 , biometric sensors 134 are located at separate locations along housing 102 . The biometric sensor 134 may include a fingerprint scanner, iris scanner, heart rate sensor, etc. Lens 132 may also include touch screen functionality to allow a user to enter a password on a keypad displayed on screen 112. The biometric sensor 134 and password element provide an additional layer of security for access to the medication using the device to identify the individual and signal the printed circuit board 126 to move the solenoid 124 to the unlocked position. to provide.

In some embodiments, dispensing device 100 further includes a photocell 136 located within the housing and connected to circuitry. Photocell 136 detects lighting conditions inside the device. Accordingly, photocell 136 can detect when dispensing device 100 is damaged or broken. In another embodiment, dispensing device 100 may further include a drug sensor 138 connected to circuitry that monitors drug levels in liquid container 118. Accordingly, drug sensor 138 may signal printed circuit board 126 when liquid container 118 is empty or has a low amount of drug remaining.

Pump assembly 120 may further include a tactile switch 140. Tactile switch 140 operates as a momentary switch that is activated when pump assembly 120 is fully activated. The tactile switch 140 is operably connected to a printed circuit board 126 on which the overall operation of the pump assembly 120 is recorded. Circuitry from printed circuit board 126 is further extended to a real-time clock chip 142. Real-time clock chip 142 may be used to provide the date and time for display on screen 112. As discussed later, real-time clock chip 142 may be used in conjunction with solenoid 124 and tactile switch 140 to lock dispensing device 100.

Referring now to Figures 4-6, drawings of an embodiment of a method according to the present invention are shown. In use, components of dispensing device 100 may communicate with a web platform accessible on computing device 200 to control drug dispensing. Printed circuit board 126 may utilize Bluetooth Low Energy (BLE) as a wireless protocol to communicate with computing device 200. Accordingly, printed circuit board 126 may be programmed from computing device 200. For example, a health care provider may adjust settings of the web platform through a terminal of computing device 200. The healthcare provider may indicate the number of administrations of medication stored in liquid container 118 and the minimum period between tours. This information is transmitted to printed circuit board 126. Printed circuit board 126 calculates the number of doses based on feedback from tactile switch 140 and determines the period between doses based on data from real-time clock chip 142.

In addition to programming the dispensing device 100, the web platform can be utilized by a healthcare provider to view status information from the dispensing device 100. For example, medication time, lock status, tampering warnings, and remaining doses are information that can be pushed from the dispensing device 100 to the web platform via a wireless network and/or cellular data, which ultimately can be used by the computing device 200. It is accessible by health care providers at the terminal. The web platform may also include a calendar interface or other scheduling format for tracking patient dosages and prescribed regimens. Accordingly, the dispensing device 100, the healthcare provider's computing device 200, and the patient's smart phone (described below) may exchange status information via GSM or some other similar digital cellular network.

Biometric sensor 134 may be programmed by the patient in the presence of a healthcare provider. For example, a healthcare provider can adjust the settings of the web platform to allow programming of the biometric sensor 134. Biometric sensor 134 may then assign the patient's identity to a specific dispensing device 100, for example by scanning the patient's fingerprint. Once programmed, biometric sensor 134 will require identification before dispensing device 100 can be used.

Once the dispensing device 100 is programmed via a web platform on the healthcare provider's computing device 200, the patient can use the dispensing device 100. To access the medication, the patient will first prove their identity by activating biometric sensor 134, such as placing a finger on biometric sensor 134 for fingerprint scanning verification. Once the patient's identity is confirmed, the patient can self-administer the first dose.

In alternative embodiments, the patient's smartphone or other computing device may serve as a second layer of authentication to utilize the dispensing device 100. For example, patients can access the web platform's patient interface from their smartphone. At medication time, patients may need to authenticate themselves via their smartphone. For example, patients can complete authentication by unlocking their phone with a password or fingerprint sensor. In another embodiment, a healthcare provider may transmit a temporary or one-time PIN code from the healthcare provider interface of the web platform to the patient interface of the web platform. Accordingly, the patient can access the web platform on his or her smart phone, search for the PIN code, and enter the PIN code into the dispensing device 100 to unlock it.

To administer the first dose, the patient holds the dispensing device 100 so that the nozzle 108 is proximal to or partially within the nostril and points the nozzle 108 toward the surface 104a of the first closed end 104. ) apply pressure. The pump assembly 120 discharges medication from the nozzle 108 so that the patient can inhale the medication. When pump assembly 120 is activated, tactile switch 140 is also triggered. Tactile switch 140 transmits a signal to printed circuit board 126 that pump assembly 120 has been activated, indicating that a dose has been administered. At the same time, printed circuit board 126 correlates the signal from tactile switch 140 with the time provided by real-time clock chip 142.

If the healthcare provider has set a minimum period between doses, receipt of a signal from tactile switch 140 will also cause printed circuit board 126 to actuate solenoid 124. Solenoid 124 moves into the path of nozzle 108 to prevent the patient from administering subsequent drug doses. Dispensing device 100 will remain in the locked position with solenoid 124 blocking operation of nozzle 108 until a minimum period of time has elapsed. The printed circuit board 126 can monitor time using data received from the real-time clock chip 142. Once a minimum time has elapsed after actuating the tactile switch 140, the printed circuit board 126 retracts the solenoid 124, allowing the patient to fully depress the nozzle 108 to administer a subsequent dose. Afterwards, the locking process is repeated.

In embodiments where one or more signal LEDs (130) are located in the housing (102), the signal LEDs illuminate red when the solenoid (124) is in the path of the nozzle (108) to indicate that a dose may not be administered; When solenoid 124 is retracted, it turns green and signals to the patient that a subsequent dose is available. Printed circuit board 126 may communicate wirelessly with computing device 200, such that a signal from printed circuit board 126 may be transmitted to computing device 200 to alert the patient that the next dose is available. . In an alternative embodiment, drug sensor 138 may transmit a signal to printed circuit board 126 and ultimately to computing device 200 indicating that liquid container 118 is empty or has a low amount of drug remaining. . This notifies the patient to begin the prescription refill process.

In embodiments where housing 102 includes photocell 136, photocell 136 may transmit a signal to printed circuit board 126 when photocell 136 detects light above a programmed threshold. It can be configured. Printed circuit board 126 may be programmed to transmit signals to computing device 200 that can be accessed by a healthcare provider. The signal may appear as an alert on the web platform notifying the healthcare provider that the dispensing device 100 has been tampered with. In a further embodiment, printed circuit board 126 is programmed to transmit data from any component or combination of components of dispensing device 100 to computing device 200 operated by a healthcare provider and/or patient. It can be. Healthcare providers and patients can then access this data to improve adherence to treatment plans.

9-15, 17, 18A and 18B illustrate two additional embodiments of dispensing devices 400 and 600, respectively. The components and/or design strategies of the various dispensing device embodiments 100, 400, and 600 are combinable or interchangeable as understood by those skilled in the art in accordance with the teachings of the present invention. For example, although not explicitly illustrated, additional embodiments 400, 600 include signal LED 130, lens 132, screen 112, photocell 136, drug sensor 138, tactile It may include a switch 140, a real-time clock 142, any combination thereof, or variations thereof. Likewise, additional embodiments 400, 600 may include suitable electrical circuits and mechanical structures to support these components.

One of the illustrated embodiments 400 includes sensors 442, 444, 446 (FIG. 14B) and visual features 490, 492, 494 (FIG. 10) for detecting the degree of play of the nozzle 460. . These sensors and visual features may be incorporated into other dispensing device embodiments 100, 600 shown herein or variations thereof, as understood by those skilled in the art following the teachings of this disclosure. . The dispensing device 100, 400, 600 locks the nozzle 108, 460, 660 when the nozzle is partially depressed for an extended period of time and/or when the user performs the partial depression and returns the nozzle to its original fully extended position. It can be configured as follows. This prevents a user from administering multiple partial doses in an attempt to circumvent the security of the dispensing device 100, 400, 600.

The dispensing devices 100, 400, and 600 may further include a ratcheting dose lock, such as the dose lock 420 shown in FIG. 13 and the dose lock 620 shown in FIG. 18A. The illustrated dose locks 420, 620 allow the nozzles 460, 660 to return to their fully extended position and allow the nozzles to be further extended when the dose locks 420, 620 are in the locked position and the nozzles are partially depressed. It operates in a ratchet manner to prevent pressing. Alternatively, the ratchet can be shaped to depress the nozzle and prevent expansion of the nozzle. Each design has specific advantages. For example, a locking ratchet (preventing depressing the nozzle) immediately prevents further administration of drug when the lock is engaged, which may be a desired feature if preventing too much drug administration is a primary concern. A dose forcing ratchet (which prevents expansion of the nozzle) prevents partial compression from occurring when the lock is engaged, but may not prevent the completion of the dose, which may be a desired feature if prevention of small doses is a primary concern. You can.

Additional embodiments 400, 600 may include one or more computing devices, such as computing device 200 shown in FIG. 1, other computing devices disclosed herein, and/or those of ordinary skill in the art according to the teachings of this disclosure. Can operate with one or more computing devices understood by. Dispensing devices 400, 600 may be used to implement the methods shown in FIGS. 4-6. Distribution devices 400, 600 may connect directly and/or remotely to a computing device (e.g., the illustrated computing device 200) via Wi-Fi/Bluetooth, cellular, etc. Control (lock/unlock, load biometrics/load new nasal spray device/change dosing schedule). Dispensing devices 400, 600 may communicate with computing device 200 to notify the physician via push notifications if a patient misses a dose or tampers with the device. Dispensing devices 400, 600 may be configured to generate output to remind the patient (e.g., by a physician) when to administer. The output may be any of a variety of outputs known in the art, including but not limited to lights, displays, sounds, or other notifications or communications to other devices, such as the patient's cell phone. Dispensing devices 400, 600 further monitor patient use of dispensing devices 400, 600 and provide information/data related to patient use directly to computing device 200 through displays on devices 400, 600. or provide another means of informing the physician about the patient's compliance with the prescription. The dispensing devices 400, 600 may have time-limited locks (pre-set by the physician) and/or scheduled locks. Time-limited lockouts may be preset by an authorized user (eg, a physician). Reserved locks may be set and/or edited remotely through a web platform (or other network platform) accessible through the physician's computing device.

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

Generally, dispensing devices 400, 600 provide safe drug delivery and include disposable components containing the drug and reusable exoskeleton or housing components. The exoskeleton holds disposable components containing the drug/drug and controls when and how the substance is dispensed. In some embodiments, the exoskeleton may secure (e.g., encapsulate) a standardized nasal spray device 500. The exoskeleton can lock and unlock the nozzle movement of a standardized nasal spray 500. Locking and unlocking (dosing) of devices 400, 600 can be controlled and/or configured remotely (Wi-Fi/BT) via mobile phone app and web platform according to doctor/physician prescription. The nozzle may include locking details that connect with the exoskeleton locking mechanism.

The standardized nasal spray device/vial 500 has a top (see dispensing device 400 shown in FIGS. 9-15) and a bottom (see dispensing device 600 shown in FIGS. 17, 18A and 18B). Can be inserted into the exoskeleton from locations including, but not limited to. Top loading dispensing device 400 may include a nozzle 460 that is removable from housing 402 . Nozzle 460 may be disposable and may be attached to a standardized nasal spray. Alternatively, a custom disposable vial containing a nozzle portion may be constructed depending on the design strategy of disposable nozzle 460. Because the nozzle 460 of the top loading dispensing device 400 is disposable, the nozzle 460 can be placed and/or cleaned separately from the reusable housing 402 of the device 400 and thus the bottom loading dispensing device. It can potentially provide better hygiene compared to (600). Bottom loading device 600 can be configured to accept standard vials 500 without requiring a special nozzle 460, thus potentially providing convenience and/or cost savings compared to top loading device 400. You can.

Dispensing devices 400, 600 may include sensors (e.g., optical/imaging) to detect nozzle movement and device tampering, and micro-movement sensors to detect user-specific movement patterns to detect when another user is handling the devices 400, 600. A drug neutralizing agent (eg, powder or sponge) may be included to chemically neutralize drug released from the sensor and/or internal vial 500. As discussed above, and as would be appreciated by those skilled in the art, one or more of these features may also be combined and/or interchanged with features of device 100.

The details of each additional embodiment 400, 600 will now be discussed in conjunction with the drawings.

Figure 9 is a side view of the top loading dispensing device 400 according to the present invention. Dispensing device 400 includes a housing 402 and a nozzle 460 that together form an exoskeleton that surrounds and (at least partially) secures a vial 500 (FIG. 10).

Nozzle 460 and vial 500 shown in FIG. 10 are snapped together. A housing interface ( 480). The combined nozzle 460 and vial 500, whether combined during or after production, may function to deliver medication with or without a housing 402, which allows a healthcare provider to administer a specific medication to a specific patient. When administering, it is possible to select whether or not to provide the drug from the housing 402. Because the nozzle 460 is not integral to the housing 402, the nozzle 460 can be disposed of or cleaned separately from the housing 402, thereby potentially providing a more sanitary alternative to a reusable dispensing device with an integral nozzle. Products can be provided. Additionally, the opening 412 through which the nozzle 460 slides during operation is the same opening through which the vial is removed, so there is no need for a second opening for vial removal. Without a second opening for vial removal, the cover 418 of the housing 402 can be smoother and therefore potentially have a more tamper-evident outer surface.

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

As used herein, the terms “fully extended position” and “fully depressed position” refer to the extremes to which the nozzle will travel for the intended purpose of delivering a dose.

Housing 402 may further include a biometric sensor 408, which may function similarly to biometric sensor 134 described elsewhere herein. For example, a fingerprint scan of sensor 408 may be used by the electrical circuitry of device 400 to determine whether to unlock a capacity lock. Additionally or alternatively, a fingerprint scan of the sensor (e.g., by a physician) may be used by the electrical circuitry of device 400 to determine whether to unlock the vial. Housing 402 may include finger covers 410 . Finger cover 410 may include a display and/or the display may be located elsewhere in housing 402.

The display may function similarly to display 112 described elsewhere herein.

Device 400 may further include a removable nozzle cap 461.

Figure 10 is a profile view of the nozzle 460 coupled to the vial 500 in the same direction as Figure 9. Referring comprehensively to FIGS. 9 and 10, the nozzle 460 and vial 500 assembled in FIG. 10 can be assembled without damaging the housing 402, and preferably without damaging the nozzle 460. It can be removed from (402). During use, nozzle 460 and vial 500 are replaceable and preferably disposable. Housing 402 can be reloaded with a new nozzle 460 and vial 500 assembly. Vial 500 may be loaded through opening 412 in upper surface 404a of housing 402. Accordingly, housing 402 includes a chamber 414 (FIG. 13) sized to accommodate a vial 500, with chamber 414 having an opening 412 in the upper surface 404a of housing 402. It can be accessed through .

When assembled to nozzle 460, the exterior surface of housing 402 may be completely devoid of fasteners or other externally accessible means for opening device 400. In some applications, it may be desirable to provide a drain hole 419 to allow liquid released from the vial 500 of the device 400 to drain from the device 400. In other applications, it may be desirable to capture liquid released from a vial 500 within device 400 (e.g., a sponge in chamber 414 shown in FIGS. 14A and 14B).

FIGS. 11A and 11B are orthogonal profile views of nozzle 460 and vial 500, where FIG. 11A is looking to the left of the assembly shown in FIG. 10 and FIG. 11B is looking to the right of the assembly shown in FIG. 10. looking at Figure 12 shows the assembly shown in Figures 10, 11A, and 11B with the nozzle 460 removed. 10, 11A, 11B, and 12, the nozzle 460 includes a conical portion 462, an engaging ring 466, a housing interface 480, a spring 478, and a retaining ring 476. Includes. Preferably, the conical portion 462, engagement ring 466 and housing interface 480 are molded into a single piece handle portion 463. Alternatively, at least one of the conical portion 462, engagement ring 466, and housing interface 480 may be individually molded and attached together to form handle portion 463.

The conical portion 462 has a dispensing end 472, a base end 474 and a fluid passageway 464 extending along the longitudinal axis L-L through the base end 474 and the dispensing end 472. Engagement ring 466 extends radially from base end 474 of the conical portion to provide an upper surface 468 against which a user can provide force against nozzle 460. Bottom surface 470 of coupling ring 466 faces away from dispensing end 472. Bottom surface 470 may be shaped or otherwise configured to contact top surface 404a of housing 402 when device 400 is assembled to prevent housing interface 480 from being pressed further into housing 402. You can. Housing interface 480 has an outer surface 482 surrounding the longitudinal axis L-L, a top portion 484 attached to a coupling ring 466, an open bottom portion 486, and an outer surface 482 extending between the top portion 484 and the bottom portion 486. It has a passage 488. The vial 500 and nozzle 460, which are assembled during the production process, are pre-assembled, so there is no need for additional assembly by the medical service provider, making it more convenient.

The nozzle 460 can be fitted into 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 extends to move over the vial 500 and may include a flexible hook 481 that snaps under a ridge of the vial to couple and secure the nozzle 460 to the vial 500. You can. The interior of the conical portion 462 and engaging ring 466 may be shaped to fit over the vial nozzle. The vial and nozzle assembly may further include an adapter or vial nozzle cover to help couple the nozzle 460 to the vial 500. In this way, nozzle 460 can be fitted over existing standard size vials. Alternatively, vial 500 and nozzle 460 may be specifically designed and/or integrated together.

Nozzle 460 includes features that function with housing 402 to control the distribution of drug within vial 500, as described in more detail below. As shown in Figures 10, 11A and 11B, drug can be dispensed when the nozzle 460 and vial assembly are outside the housing. This allows medicines to be packaged identically regardless of whether they are regulated during use, improving convenience and potentially reducing costs.

10, the housing interface includes openings 490, 492, and 494 in the outer surface 482 to help detect partial depression of the nozzle 460. As the nozzle 460 is pressed onto the vial 500, movement of the housing interface 480 relative to a portion of the nozzle 460, such as the retaining ring 476, is visible through the openings 490, 492, and 494. there is. Housing 402 may include one or more sensors to sense movement of a portion of nozzle 460 (e.g., retaining ring 476) over openings 490, 492, 494. Figure 10 shows three openings 490, 492, 494 positioned so that the three depressed positions of the nozzle 460 can be detected. Housing interface 480 may include one or more openings 490, 492, 494 to serve the same purpose, where the maximum number of openings is as understood by a person skilled in the art in accordance with the teachings of the present invention. Limited by physical design constraints. Preferably, the outer surface 482 of the housing interface 480 has a high visual contrast with the retaining ring 476 so that the retaining ring 476 can be easily visualized relative to the housing interface 480 by an optical sensor. . When the nozzle 460 and vial 500 assembly is installed in the housing 402, the retaining ring 476 is substantially fixed relative to the optical sensor, while the openings 490, 492, 494 are positioned in the retaining ring 476. The optical sensor moves to cover and reveal the field of view. The optical sensor detects movement of the top and bottom openings 490 and 494 of the housing interface 480 to determine movement at the start and end of administration. If the dose has been initiated but not fully pushed to the bottom, the dose lock 420 will engage (described in more detail with respect to FIGS. 13 and 14B).

10 and 11A, the housing interface 480 has an indentation 496 to secure the pressing of the nozzle 460 into the housing 402, i.e., to prevent the user from receiving the dose. Includes. Two indentations 496 are shown. The lower indentation is positioned to maintain the nozzle in the fully extended position when housing interface 480 is slidably coupled to housing 402.

13 and 14B illustrate the housing dose lock 420 engaging the indentation 496 of the nozzle 460.

Referring collectively to FIGS. 10, 11A, 13, and 14B, during the intended use of device 400, the user allows the nozzle to return to the fully extended position after each application of medication, and retracts the nozzle after application is complete. 460 is secured in the fully extended position by engaging the lower indentation with dose lock 420. However, a user may inadvertently or intentionally partially depress the nozzle at the same time that the dose lock 420 of the housing 402 (see FIGS. 13 and 14B) is engaged. In this case, the upper indentation engages the dose lock 420 and is positioned to prevent further compression of the nozzle if it is partially depressed. At least the upper indentation may have an angled shape so that the dose lock can slide down from the indentation 496 to further extend the nozzle 460 from the housing 402, even if the nozzle 460 is prevented from being pressed further. . In use, when the nozzle 460 is locked and the upper groove is engaged with the vial lock, when the force pressing the nozzle 460 is removed, the spring 478 moves the nozzle 460 to a fully extended position outside the housing 402. push towards As a result, the dose lock 420 can slide from the upper indentation to the lower indentation. Although one upper indentation is shown, the housing 402 may further include additional angled indentations positioned to engage the vial lock when the nozzle 460 is depressed in multiple partially depressed positions. The angled notch can thereby act as a ratchet to allow one-way movement of the nozzle 460 when the vial lock is engaged. The number and location of angled notches may be determined by physical design constraints as understood by those skilled in the art.

Thereby, the ratcheting action of the dose lock 420 can block a user attempting to flip the dose lock 420 when the user applies a dose (by pressing the nozzle 460), and then the nozzle 460 ) slowly toward the extended position, stopping just before reaching the fully extended position and engaging the lower indentation 496 (see also Figure 13) and then attempting to press the nozzle 460 again.

Referring to Figure 11B, housing interface 480 may further include a vial lock opening 498. Vial lock opening 498 may be shaped, sized, and otherwise configured to engage vial lock 430 of housing 402 (see FIGS. 13 and 14B). If the vial lock extends into the opening 498, engagement of the vial lock with the lower ledge 499 of the opening 498 may prevent the nozzle from being pulled out of the housing 402. The opening 498 can be sized so that when the nozzle 460 is depressed to deliver drug, the vial lock moves freely through the opening 498. The opening can be further sized such that the vial lock engages the upper ridge 497 of the opening 498 to establish a fully extended position of the nozzle 460. Alternatively, the fully extended position of nozzle 460 may be achieved through the combination of additional features on housing 402 and housing interface 480, as understood by those skilled in the art according to the teachings of this disclosure. Get setup and/or help.

Figure 13 is a cross-sectional view of device 400 cut along plane B and oriented as shown in Figure 9. Several components of housing 402 have been removed to highlight the dose lock 420 and vial lock 430. Additional components of housing 402 (including chassis 416) are shown in FIGS. 14B and 15.

Each lock 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 dose lock is coupled to the lower indentation 496 of the housing interface 480, and the sliding extension of the vial lock ( 432) is coupled to the lower ridge 499 of the vial lock opening 498 of the housing interface 480.

When both the dose lock 420 and the vial lock 430 are locked and the nozzle is in the fully extended position, the dose lock 420 prevents the nozzle 460 from being depressed and the vial lock prevents the nozzle 460 from being extended. prevent it from happening. When the dose lock 420 is opened, the vial lock 430 provides a stop for establishing the fully depressed position of the nozzle 460.

The lower ridge 499 of the vial lock opening 498 and the bottom and mating surface of the sliding extension 432 of the vial lock 430 are inclined downward and inward, respectively. When in this position, vial lock 430 is prevented from disengaging from housing interface 480, while dose lock 420 remains coupled to lower indentation 496. When the user attempts to pull the nozzle 460 out of the housing 402, the sliding extension 432 slides against the lower ridge 499 and extends further into the housing interface 480 to engage the housing interface 480 and further. It can fit together.

To remove nozzle 460 and vial 500, an authorized user (e.g., a physician or pharmacist) will send a command to dispensing device 400 to remove vial 500. Dose lock 420 is released and an authorized user pushes down on nozzle 460 to release the undercut in housing interface 480 and opens a sensor (e.g., one or more openings 490, 492, 494). An optical sensor) detects that nozzle 460 has been depressed, vial lock 430 is unlocked and vial 500 can be removed.

Opening each lock 420, 430 may include rotation of a respective motor 426, 436, which causes each cam 242, 434 to rotate and each sliding extension 422, 432. separates the housing interface 480 by sliding outward from the housing interface 480. Closing each lock 420, 430 may include reverse rotation of each motor 426, 436, which causes each cam 242, 434 to rotate in the opposite direction of opening each sliding extension. By releasing 422, 432, springs 428, 438 (FIG. 14B) push each sliding extension 422, 432 toward housing interface 480 to engage housing interface 480.

Dose lock 420 may include an angled sliding extension 422 shaped to engage an indentation 496 in the housing interface 480 of the nozzle 460. Extension 422 of dose lock 420 may be ratcheted across multiple indentations 496 (see FIG. 11A).

14A and 14B are plan views of the housing 402 orthogonal to planes A and B, respectively. Figure 14B is a cross-sectional view of housing 402 cut in plane C as shown in Figure 13.

14A illustrates the upper surface 404a, opening 412, chamber cavity 414, sliding extension 422 of dose lock 420, and sliding extension 432 of vial lock 430. Vial lock 430 includes upper and lower pins. The lower pin is shaped to engage the lower ridge 499 of the vial lock opening 490 of the housing interface 480 of the nozzle 460, as shown in FIG. 13.

Figure 14B shows additional component parts of housing 402 and locks 420 and 430. Each lock 420, 430 has a respective spring attached to each sliding extension 422, 432 to move the lock 420, 430 to a closed position when each cam is positioned as shown. 428, 438). Cams 424, 434 are positioned as mirror images of each other, and may alternatively be positioned differently as would be understood by those skilled in the art in accordance with the teachings of this disclosure. To open the locks 420, 430, the cam 424 of the dose lock 420 abducts clockwise and the cam 434 of the vial lock 430 rotates counterclockwise (i.e., cam 424 , 434) in the opposite direction due to mirror symmetry). As each cam (424, 434) rotates, it engages with each of the bumps (423, 433) on each of the sliding extensions (422, 432), pushing the springs (428, 438) and sliding the extensions (422, 432). ) moves outward to the open position. The bumps 423 and 433 are located at the center of each sliding extension 422 and 432 to minimize lateral movement of the extensions 422 and 432, and thus risk interfering with the lock compared to non-centered engagement. decreases. The bumps 423, 433 and cams 424, 434 are preferably configured such that the cams 424, 434 have a small contact area and therefore lower friction compared to a larger contact area.

Another option is to have one or both cams 424, 434 rotate more than 90 degrees over the bumps 423, 433. This option allows more options for motor selection as it does not rely on the friction of the motor gearbox to hold the locks 420, 430 open.

Each lock 420, 430 includes a stop 415, 417 against which the vertical extensions 425, 435 of each cam 424, 434 press when the cam reaches the end of its rotational movement. Each stop 415, 417 is preferably integral to the chassis 416 of housing 402 (see also FIG. 15) rather than each sliding extension 422, 432. The stops 415 and 417 integrated into the chassis 416 have a greater force than the stops integrated into the sliding extension 422 when each cam 424 and 434 engages with the respective stops 415 and 417. The possibility of rotation (and therefore jamming) of each sliding extension 422, 432 can be reduced. Chassis 416 may also provide structural support for or be coupled to springs 428, 438 and motors 426, 436.

Referring to FIG. 14B, housing 402 includes a printed circuit board 440 to which electrical components are connected that together form electrical circuits for performing the various functions of device 400. Circuit board 440 includes a processor and a non-transitory computer-readable medium with instructions that, when executed by the processor, cause the electrical circuitry to perform the functions described herein, including the functions described with respect to the system shown in FIG. 1. may include. The circuit board 440 does not need to have a specific shape as shown. The electrical circuitry of housing 402 may include, for example, rigid boards, flexible circuits, individual components, free wiring, and/or combinations thereof. As will be understood by those skilled in the art following the teachings of this disclosure, various types of electrical circuits may be utilized to perform the functions described herein. The electrical circuitry of device 400 may further include a drug sensor 138, a tactile switch 140, and/or a real-time clock as described elsewhere in this disclosure.

The electrical circuit includes three optical sensors 442, 444, and 446 mounted on a circuit board 440. Each of the sensors 442, 444, and 446 is positioned to view a respective opening 494, 492, and 490 in the housing interface 480 of the nozzle 460. Each sensor 442, 444, and 446 is configured to provide a sensor signal indicative of a depressed position of the housing interface. At least intermediate 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 partial depression of nozzle 460 may be useful to determine appropriate administration of medication and/or to prevent tampering. In some embodiments, the electrical circuit may be configured to close the dose lock 420 in response to receiving a sensor signal from a central sensor indicating a partially depressed position and/or repeated partial depression of the nozzle 460. . In some embodiments, the processor is configured to receive sensor signals and execute instructions in memory to cause electrical circuitry to activate motor 426 to rotate cam 424 and close lock 420.

Device 400 may include additional or alternative sensors and/or indicators to detect partial depression of nozzle 460. As an example, housing interface 480 may include a high contrast image instead of apertures, such as a series of horizontal lines across the outer surface 482 of housing interface 480. As nozzle 460 is depressed, electrical circuitry can determine the number of lines that have passed in front of one or more optical sensors 442, 444, 446 based on signals from the sensor(s). Additionally, or alternatively, the horizontal lines may vary in thickness, thereby producing distinct sensor signals depending on which line is viewed by the optical sensor. As another example, the housing interface 480 may include a conductive strip and the circuit board 440 may include two or more contacts arranged such that the conductive strip and simultaneous electrical contact are made when the nozzle 460 is partially depressed. You can. Electrical circuitry in housing 402 may detect partial depression of nozzle 460 at one or more partial depression positions by detecting when a contact is shorted.

The top and bottom openings 490, 494 can be used to determine when the nozzle 460 is in the fully extended and fully depressed positions. Alternatively, housing 402 may include limit switches to detect when nozzle 460 is in a fully extended position and/or a fully depressed position.

Engagement of cams 424, 434 with respect to stops 415, 417 can be detected by monitoring the current to the corresponding motors 426, 436. If the electrical circuit detects an increase in current that exceeds a predetermined threshold (e.g., provided by an instruction in memory), the electrical circuit may reduce or eliminate power to the motors 426, 436.

The electrical circuit may further include a sensor (e.g., an optical sensor) for detection of the vial 500.

The electrical circuit may be powered by a battery 448 integrated into the housing 402. The electrical circuit may include battery charge regulation and battery protection circuitry (eg, overvoltage, undervoltage, overcurrent, etc.).

The electrical circuit may be configured to maintain the dose lock 420 for a set amount of dosage (e.g., entered by a physician or pharmacist) and then return the dose lock 420 to the closed/locked position. there is. When returned to the closed/locked position, spring 428 pushes dose lock extension 422 into engagement with housing interface 480.

Figure 15 shows an exploded view of the component parts of device 400 and vial 500. The nozzle 460 includes a handle portion 463, a spring 478, and a retaining ring 476. Vial 500 includes a liquid container 502, atomizer 504, and vial nozzle 508. Housing 402 includes a top cover 451, a light guide 453, and an upper ring 454 that together form an upper surface 404a of housing 402. Housing 402 further includes a light emitting diode (LED) board 452 containing LEDs positioned to illuminate light guide 453 . The same or additional LEDs may provide illumination to the optical sensor in housing 402. The component parts of the dose lock 420 and vial lock 430 are secured to the chassis 416 by respective locking covers 427 and 437. The circuit board 440 is equipped with a scan nest 456 on which a biometric sensor 408 can be mounted. Locking covers 427, 437 and circuit board 440 are attached to the chassis by screws 455. Of course, alternative fasteners, adhesives, snaps, or other strategies may be used to secure component parts within chassis 416 and/or housing 402, as will be understood by those skilled in the art following the teachings of this disclosure. You can.

Housing 402 may be charged via inductive charging. Housing 402 includes an induction coil 450 located within cover 418, near bottom end 406 of device 400. Cover 418 may include a co-mold ring 457 near bottom end 406 for additional stability to prevent device 400 from tipping over during charging. The electronic circuitry of housing 402 may include circuitry for inductive charging of battery 448 with coil 450 including circuitry designed according to currently available inductive chargers and other wireless charging schemes not yet developed. Integrating wireless charging into the housing eliminates the need for a charging port, eliminating any user entry points, providing a more robust device against tampering compared to devices with wired charging ports. Additionally, because the user does not have direct access to the charging mechanism, wireless charging devices may be more resistant to damage (at least to the charging circuitry) compared to devices with wired charging ports.

The entire assembly has no exposed screws in the cover 418 that is secured over the chassis 416. The functionality of the mechanical and electrical components can be assembled and tested on the chassis 416 prior to fitting the cover 418.

Figures 16A-16C illustrate alternative handle portions 463 of the nozzle of the dispensing device 400 shown in Figures 11A and 11B. The handle portion 463 is made of two separate parts: an upper portion 463a and a lower portion 463b. The upper portions 463a, 463b include clips 465 that can engage with each other to secure the upper portion 463a to the lower portion 463b in a tamper-proof manner, which allows the upper portion 465a and the lower portion ( 465b) means that it cannot be easily separated by the drug recipient. The handle portion 463 may include a cradle 467 sized to receive the push tab 510 of the vial nozzle 508 (see FIG. 15 ). Cradle 467 may be sized to accommodate larger push tabs 510 that can be found on many vials 500 currently used in the industry.

Nozzle 460 of dispensing device 400 with handle portion 463 shown in FIGS. 16A-16C removes vial nozzle 508 from vial 500 and retains retaining ring 476 and spring 478. is placed over the vial 500, sliding the housing interface 480 over the spring and retaining ring 476 and pressing tab 510 positioned within the cradle 467 of the lower portion 463b of the handle portion 463. Preferably position the vial nozzle 508 on the vial 500, snap the upper portion 463a of the handle portion 463 onto the vial nozzle 508 and secure the lower portion 463b of the handle portion 463. By doing so, it can be mounted on the vial 500. The order of attaching the nozzle 460 to the vial 500 may be performed in a variety of ways, and steps may be performed in a different order than the listed order, as will be understood by those skilled in the art; For example, vial nozzle 408, spring, and/or retaining ring 476 may be secured within handle portion 463 before vial 500 is inserted into handle portion 463. Housing interface 480 may extend to move over vial 500 and include a flexible hook 481 that snaps under the curvature of the vial to couple and secure nozzle 460 to vial 500. Once 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. You can.

16A-16C illustrate one example geometry of the handle portion 463 with separate portions that can secure the vial nozzle 508 in a tamper-evident manner. Other alternatives, including the handle portion 4763 comprising two vertically divided portions and/or more than two separate portions, may be constructed as would be understood by those skilled in the art.

Figure 17 is a diagram showing an exploded view of another embodiment of the dispensing device 600 according to the present invention. Figure 18A shows a cross-sectional view of the dispensing device in plane A as indicated in Figure 17. Figure 18B shows a cross-sectional view of the dispensing device in plane B as indicated in Figure 17.

The difference between the dispensing device 600 shown in FIG. 17 and the device 400 shown in FIGS. 9-15 is that the vials 500 are loadable from the bottom of the device 600 and are integral with the housing (i.e., damaged or damaged). Includes nozzle (non-separable without special disassembly). The dispensing device 600 illustrated in FIG. 17 may provide partial dose detection, biometric scanning, wireless and/or wired communication to other computing devices, programmability for defined doses, micro-motion detection, drug identification, drug administration. Electrical circuits and components (e.g., mechanical and/or electrical components) to perform dose sensing and other functions described in connection with other dispensing device embodiments 100, 400 described elsewhere herein. ) can have.

17, 18A, and 18B, the dispensing device 600 includes a handle portion 663, a top cover 651, an LED board 652, a light guide 653, an upper rim 654, Housing interface (680), spring (678), chassis (616), battery (648), biometric sensor (608), sliding dose lock extension (622), dose lock cam (624), dose lock motor (626) , C-shaped vial lock extension 632, vial lock cam 634, vial lock motor 636, circuit board 640, cover 618, finger cover 610, cover co-mold (co- mold) (657) and a base (658).

Top cover 651, LED board 652, light guide 653 and top rim 654 are corresponding components 451, 452, 453, 454 of dispensing device 400 shown in FIGS. 9 to 15. It is assembled similarly.

The nozzle of device 600 includes a handle portion 663, spring 678, and housing interface 680. The handle portion 663 has a conical portion and engaging ring similar to the conical portion 462 and engaging ring 466 of the handle portion 463 of the nozzle 460 of the dispensing device 400 shown in FIGS. 9 to 15. Includes. The handle portion 663 and the housing interface 680 are clipped to each other.

The housing interface 680 includes features thereon for detecting partial collapse of the nozzle similar to the features on the outer surface 482 of the housing interface 480 of the dispensing device 400 illustrated in FIGS. 9-15. It has an outer surface 682. Likewise, the electrical circuitry of device 600 (i.e., circuit board 680 and other electrical components) includes sensors to sense the position and/or movement of features of housing interface 680.

Device 600 includes a limit switch to sense when the nozzle of device 600 is in a fully extended position and/or a fully depressed position. Additionally or alternatively, device 600 may be configured to detect when a nozzle of device 600 is in a fully extended position and/or a fully depressed position, such that the device 600 is configured to detect when the nozzle of device 600 is in a fully extended position and/or a fully depressed position. , may include an opening in the housing interface 480 similar to 494).

It further includes an indentation 696 positioned to engage the dose lock extension 622 of the housing interface 680. Indentation 696 may be angled to prevent compression and allow extension of the nozzle when handle 663 is partially depressed. Dose lock 620 (including dose lock extension 622, cam 624, and motor 626) has the functions of dose lock 420 and the indentation of device 400 shown in FIGS. 9-15 ( It can be ratcheted across indentation 696 similarly to 496). Dose lock extension 622 includes an angled ridge 695 that fits within an angled indentation 696. The dose lock extension 622 has a ring shape. The dose lock is pressed into the locked position by a spring 628. The cam 624 and motor 626 of the dose lock are located on the opposite side of the ring of the dose lock extension 622 (relative to the angled ridge 695). To open the dose lock, a motor 626 rotates a cam 624 that presses the dose lock extension 622 against the force of a spring 628 to move the angled ridge 695 out of the indentation 696. It is activated to do so.

Vial lock 630 includes a C-shaped vial lock extension 632, vial lock cam 634, and vial lock motor 636. The general orientation of vial lock 630 is similar to vial lock 430 of device 600 shown in FIGS. 9-15 to facilitate removal of vial 500 through bottom 606 of device 600. It is upside down compared to . Base 658 fits into chassis 616 and is held in place by engaging vial lock extension 632 into indentation 698 in base 658. To open vial lock 630, motor 636 is activated to rotate cam 634, thereby disengaging vial lock extension 632 from indentation 698 in base 658. Vial lock extension 632 is held in the locked position by a spring and is opened by activating vial lock motor 646 to rotate cam 634 to push vial lock extension 632 against the spring. Base 658 may include indentations at various angles to ratchet base 658 into device 600 . The ratchet may prevent base 658 from moving out of device 600 and allow base 658 to move into device 600 .

Alternatively, vial lock 630 may include a ring gear lock surrounding vial 500. Alternative designs may increase system reliability or reduce production costs. The motor rotates the ring gear lock to release the vial lock while the vial holder/base 658 is in place. If vial 500 is not present, the ring gear lock returns to the locked position. Base 658 can then be pushed back into place. The locking clip moves under the action of a plastic spring and locks the base.

The positions of dose lock 620 and vial lock 630 are such that cams 624, 634, respectively, are driven by respective motors 626, 636 as described with respect to device 400 shown in FIGS. 9-15. This is detected by measuring the increase in current when rotated to a similar stationary state.

Device 600 further includes a sensor (e.g., a limit switch or optical sensor) to detect the presence of vial 500.

The entire assembly may not have exposed screws with cover 618 secured over chassis 616. Before fitting the cover 618, the functionality of the mechanical and electrical components can be assembled and tested on the chassis 616.

Device 600 includes a mini USB port for charging. Alternatively, device 600 may include coil or inductive charging and/or alternative charging ports such as USB C, proprietary charging ports, or other charging ports as understood by those skilled in the art according to the teachings of this disclosure. can do.

19 shows a system diagram of an example system including digital platform 700, user device 800, and distribution device 900. Digital platform 700 and user device 800 each represent the computing device 200 exemplified herein, an alternative thereto, and/or the same, as can be recognized and understood by those skilled in the art in accordance with the teachings of this disclosure. May include variations. Dispensing device 900 may be any of the dispensing devices 100, 400, 600 shown herein, an alternative thereto, and/or any of the dispensing devices 100, 400, 600 shown herein, and/or any of the dispensing devices 100, 400, 600 shown herein, and/or any of the dispensing devices 100, 400, 600 shown herein, and/or any of the dispensing devices 100, 400, 600 shown herein. May include variations thereof.

An authorized user 702 (e.g., a physician) may receive information related to prescription compliance, nozzle location, vial type, patient information, device information, prescription information, dosage information, and dispensing device tampering via the digital platform 700. there is. The information may be provided as an output 904 of the dispensing device 900. Authorized users 702 may enter commands related to nozzle locking/unlocking, vial locking/unlocking, and/or biometric loading/clearing via digital platform 700. The digital platform may communicate with the distribution device 900 through an application on the user device 800 .

A user (e.g., a patient) may be authenticated by the dispensing device 900 via a user device 800 and/or a biometric scanner 908. User device 800 may additionally receive information related to medication schedule, reminders, and prescription compliance from dispensing device 900 .

Dispensing device 900 may include a motor 926 and a cam 924 positioned to engage a nozzle locking mechanism 922. Motor 926, cam 924, and nozzle locking mechanism 922 position the nozzle to prevent dispensing, modification thereof, or alternatives thereto, as understood by one of ordinary skill in the art according to the teachings of this disclosure. may have a structure and/or function similar to the structure of the dispensing device 100, 400, 600 described herein to lock.

Dispensing device 900 may include a motor 936 and a cam 934 positioned to engage a vial locking mechanism 932. The motor 936, cam 934, and vial locking mechanism 932 are used to secure the vial within the dispensing device as understood by a person skilled in the art according to the teachings of this disclosure. Devices 100, 400, and 600 may have a similar structure and/or function as those of devices 100, 400, and 600, variations thereof, or alternatives thereto.

Dispensing device 900 may receive a vial, such as vial 500, as a variation or alternative thereto, as understood by those skilled in the art according to the teachings of this disclosure.

Dispensing device 900 may include a nozzle 960 that can be depressed to dispense medication and may include features, variations thereof, and features for locking and/or dose detection as described elsewhere herein. The teachings of the disclosure may provide alternatives thereto as understood by those skilled in the art.

Dispensing device 900 may detect partial depression of nozzle 960, detect the presence of vial 500, entry into dispensing device 900, and/or an optical sensor as described elsewhere herein. optical sensors 944 for detecting other functions, variations thereof, and alternatives thereto as understood by those skilled in the art according to the teachings of this disclosure.

Dispensing device 900 may include a gesture sensor 901 (e.g., a micro-motion sensor) that detects user-specific movement patterns to detect when another user is handling device 900.

20A and 20B illustrate an alternative handle portion 763 and circuit board 740 that can be used in place of the handle portion 463 and circuit board 440 of the dispensing device 400 illustrated in FIGS. 9-16C. Illustrate. The handle portion 763 illustrated in FIGS. 20A and 20B has an indentation 796 configured similarly to corresponding features 460, 466, 480, 496 of the handle portion 463 illustrated in FIGS. 9-16C. It may include a nozzle 760, a coupling ring 766, and a housing interface 780. Handle portion 763 and circuit board 740 may be configured to function with other dispensing devices disclosed herein, variations thereof, and alternatives thereto, as understood by those skilled in the art.

The handle portion 763 illustrated in FIGS. 20A and 20B includes a high contrast graphical image 791 in place of the openings 490, 492, and 494 shown in FIGS. 10, 15, 16A, and 16C. Circuit board 740, shown in FIG. 20B, includes sensor 741 positioned for viewing high contrast graphical image 791 and associated hardware and software for operating sensor 741. When the handle portion 763 is pressed or released, the image 791 moves with the handle portion 763.

The high-contrast image 791 may be, for example, printed on a sticker and then attached to the housing interface 780, or the image 791 may be printed directly on the housing interface 780, and/or the image ( The housing interface 780 can be overmolded/co-molded with the housing interface 780 by a variety of means, such as where 791) can be overmolded/co-molded with the housing interface 780 with a material whose visible light reflection and/or IR light reflection contrasts with the primary material of the housing interface 780. can be applied to The size of image 791 may be approximately 14mm*14mm. The image size may be adjusted to occupy a convenient portion of the housing interface 780 and/or the image size may be adjusted to achieve sensor resolution in accordance with the teachings of this disclosure as would be understood by those skilled in the art. For example, an image may have a maximum size limit determined by the area of the housing interface 780 and other geometric factors of the dispensing device 400 and a minimum size limit determined by a minimum sensor resolution design parameter. Image 791 may include a dark triangle 793 on a bright background or another image with a change in the amount of dark to light space in the longitudinal axis (L-L) direction. The base of the dark triangle may be aligned to a first end of image 791 and the base of the light triangle may be aligned to a second end of image 791 such that the dark and light triangles interleave. As illustrated, the base of the dark triangle is at the top of image 791 and the base of the light triangle is at the bottom of image 791. However, this orientation is reversed with the base of the light triangle at the top of image 791 and the base of the dark triangle at the bottom of image 791 through modification in software, as will be understood by those skilled in the art. It can be.

Sensor 741 may be configured to measure handle position on a single sample without requiring comparison with previous samples. Sensor 741 may be configured to determine the depressed length of nozzle 760 at high resolution. Resolution can be determined by several means, as understood by those skilled in the art. For the purpose of providing a numerical value of the resolution here, the output of the sensor is recorded as the handle portion 763 is moved over a range of approximately 5 mm by a numerically controlled positioner. The recorded output is statistically compared to the controlled position to calculate the repeatability and linearity of the sensor output. Linearity is expressed as the standard deviation of the difference in output from each position to the next when the handle portion 763 is moved in 0.5 mm increments over a 5 mm range. Repeatability is expressed as the maximum value of the standard deviation of the output sample for each position in the 3mm range after moving the handle portion 763 up and down 5 times in the 2mm range. Resolution is expressed in counts per mm, the number of sensor output counts between two positions at 4 mm intervals divided by 4, and has low repeatability and linearity.

In a preferred example, the sensor may have a resolution of at least about 4 counts per mm, up to at least 500 counts per mm. A pressure detected at about 815 counts per mm can be accurate to a measurement error of about 64 counts, or about 83 micrometers. Sensor 741 can operate continuously at a sampling rate of 10 samples per second at an average power consumption of approximately 47 microwatts with a resolution of approximately 815 counts per mm. In another example, the sensor may have a resolution of greater than about 4 counts per mm, up to about 2350 counts per mm. Pressures detected at 2350 counts per mm are repeatable with a measurement error of about 20 counts, or about 8 micrometers. Sensor 471 can operate continuously at a current of 0.015 mA with a resolution of 2350 counts per mm. Sensor 471 can operate continuously at a current of approximately 0.0004 mA with a resolution of approximately 500 counts per mm.

Sensor 741 and image 791 may be low profile, and preferably the main board of circuit board 740 may be a distance D1 of approximately 2.5 mm from housing interface 780. The sensor 741 can be separated from the housing interface 780 so that the graphic image 791 does not contact the sensor 741, so pressing the housing interface 780 may cause damage to the graphic image 791 or the sensor 741. does not occur Sensor 741 may be immune to external magnetic fields and influences such as sunlight, magnets, etc. Sensor 741 can be robust to production tolerances and drift. Sensor 741 may be configured to have a high sampling rate so that rapid fractional doses can be detected. Sensor 741 may be configured to detect the presence of a vial. Sensor 741 and circuit board 740 may be configured to perform an automated calibration procedure when handle portion 763 and vial 500 are inserted into housing 402. Sensor 741 may include only a single sensor or may include a second sensor for calibration and/or redundancy. Sensor 741 may operate without lenses or other optical features.

Sensor 741 may be configured to sense the reflectance of image 791. Sensor 741 includes an infrared (IR) proximity sensor, and preferably also includes a wide-angle IR light emitting diode (LED). IR LEDs may be positioned to illuminate image 791. Sensor 741 may be configured to detect changes in IR reflectance provided to sensor 741 as image 791 moves. Sensor 741 may be configured to detect the presence of vial 500 using IR distance sensing.

Generally, IR proximity sensors are currently used to detect motion or measure distance in several applications such as autofocus, motion recognition, etc. When measuring distance, IR light is emitted, and an IR proximity sensor measures the intensity of the IR light reflected from the object to the detector, where the intensity is inversely proportional to the distance from the object to the detector. To achieve excellent performance, these sensors utilize several technologies to provide a wide dynamic measurement range in the presence of strong interference (e.g. sunlight) and at very low power. IR proximity sensors may include circuitry, materials and techniques, including those known in the art, to provide immunity to external fields and influences such as sunlight, magnets, etc.

IR proximity sensors are generally designed to detect targets located at a distance much greater than the distance D1 between sensor 741 and image 791, as shown in FIG. 20B. Therefore, a typical IR proximity sensor contains a narrow beam IR emitter positioned far away from the detector. Narrow beams are desirable to achieve accurate measurements at longer distances. Sensor 741 of dispensing device 400 preferably includes a wide-angle IR light source (e.g., LED) used instead of or in addition to a narrow beam IR emitter. A narrow beam IR emitter can be used to determine the presence of vial 500, while a wide angle IR light source can be used to determine movement in image 791, for example.

Image 791 preferably has high contrast with respect to IR reflectance. Image 791 may include, as a non-suggestive example, a black polyvinyl chloride (PVC) on white plastic and/or black laser printed image on white paper. A black image thermally printed on white paper may have much lower contrast with respect to IR reflectance than a black polyvinyl chloride (PVC) on white plastic and/or black laser printed image on white paper.

Additionally or alternatively, sensor 741 may include a visible light sensor and a visible light source to detect depression of handle portion 763. The visible light sensor may replace the IR proximity sensor for detecting depressing of the handle portion 763 and/or may be used in addition to the IR proximity sensor as a redundant and/or compensating sensor for depressing of the handle portion 763. .

Sensor 741 may be configured to perform a line scan of image 791, with the line scan changing as handle portion 763 moves. Sensor 741 may have a short dimension in the longitudinal axis (L-L) direction and a long dimension orthogonal to the longitudinal axis (L-L), with the long dimension being substantially larger than the short dimension.

Figure 21 shows image 791a configured to provide reflectivity to a rotation sensor. The principles described with respect to sensor 741 and image 791 described with respect to FIGS. 20A and 20B provide a non-contact, high-resolution sensor for determining the position and/or angular rotation of a component within a mechanical device or system. It can be used in other applications (i.e., not limited to the dispensing device 400). Example image 791a may include tapered arcuate bands with a wide base at a first angle of rotation and an end tapered at a second angle of rotation. Measuring the angle counterclockwise, Figure 21 shows a tapered arcuate dark band with a wide base at 0 degrees and a tapered tip at 180 degrees, and an interleaved taper with a wide base at 180 degrees and a tapered tip at 0 degrees. It shows a true arcuate bright band. Image 791a may have a shape geometrically related to a circle, such as a pie wedge, annulus, annular sector, etc. Image 791 may have a center point defined by the trajectory of a tapering arcuate band. The image 791a and the sensor 741 may be secured in relation to each other at the center point of the image 791a. At least one of the sensor 741 and the image 791a is rotated about a central point so that the sensor 741 moves along the arc of the arcuate band and/or the image 791a moves the arc of the arcuate band across the sensor. It can be configured to do so. The resolution of the sensor 741 may be determined by the number per unit angle (eg, degrees or radians).

Additional alternative means for detecting pressure on the handle portion are also considered. Sensing means may be combined for redundancy and/or calibration of the dispensing device. The linear magnetic field sensor may be arranged to sense movement of magnetic dipoles on the handle portion such that the magnetic field strength and direction at the sensor changes when the handle portion is moved. A capacitive sensor may include a metal plate on a circuit board and a metal plate on a handle portion such that an electric field is coupled between the sensor plates with a magnitude proportional to the overlap of the plates, with the handle portion moving relative to the circuit board. As this happens, the overlap of the plates changes. The resistive sensor may include a potentiometer positioned on a circuit board having a knob that rotates relative to ribs of the handle portion when the handle portion moves relative to the circuit board, thereby adjusting the resistance of the potentiometer. It can change. One or more microswitches are attached to a circuit board using a rocker that engages a mechanical rib on the handle that causes the microswitch to toggle between open and closed when the handle portion is moved relative to the circuit board when the handle portion is depressed. can be located The light blocking sensor includes a light sensor arranged to detect light through an opening in the handle portion and a light source arranged to provide light through the opening in the handle portion; The aperture may include horizontal ribs or modulated scales. The magnetic field sensor can be positioned to sense the magnetic scale of the handle portion such that the magnetic field at the sensor alternates as the scale moves with the handle portion. The motion tracking integrated circuit can be positioned to view the image on the handle such that when the handle is moved relative to the motion tracking integrated circuit, the motion tracking integrated circuit detects movement of the image. The color sensor may be positioned to view the image as a color gradient of the handle portion illuminated by a white light source such that the color of the light reflected by the color sensor changes as the image moves with the handle portion. The image of the handle portion may have a black-and-white border, and sensors on the circuit board may include one or more of an IR light reflection sensor, an IR proximity sensor, and an ambient light sensor to cause the total amount of reflected light to change depending on the position of the handle portion. You can.

Although the invention has been shown and described with reference to specific exemplary embodiments, those skilled in the art can make various detailed changes without departing from the spirit and scope of the invention or limiting the invention as claimed herein. You will understand that you can. Additionally, where example embodiments are described with reference to a specific number of elements, it will be understood that the example embodiments may be practiced utilizing fewer or more than the specific number of elements.

Claims (20)

a nozzle comprising a conical nozzle portion, a housing interface configured to be attached to a vial, and a graphical image located on an exterior surface of the housing interface; and
It includes a housing including a chamber sized to accommodate the vial, an opening connected to the chamber, and a sensor,
the housing interface is positioned within the opening and configured to slide through the opening upon movement of the nozzle relative to the housing,
wherein the sensor is configured to detect movement of the graphical image upon movement of the nozzle relative to the housing. The nasal spray device of claim 1, wherein the graphical image comprises a printed image on a label affixed to the exterior surface of the housing interface. 3. The nasal spray device of claim 1 or 2, wherein the graphical image comprises a print applied directly to the exterior surface of the housing interface. 4. The nasal spray device of any preceding claim, wherein the graphical image comprises a material configuration that is separate from a majority of the housing interface and is overmolded and/or co-molded with the housing interface. 5. The nasal spray device of any one of claims 1 to 4, wherein the graphic image comprises infrared reflection and high contrast. 6. The method of any one of claims 1 to 5, wherein the graphical image comprises interleaved dark and light triangles, wherein the base of the dark triangle is aligned with a first end of the graphical image, and A nasal spray device, wherein a base is aligned with 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. 7. The nasal spray device of any preceding claim, wherein the sensor is configured to measure the position of the nozzle relative to the housing in a single sample without the need for comparison with a previous sample. 8. The nasal spray device of any preceding claim, wherein the sensor is configured to measure the position of the nozzle relative to the housing with a measurement error of about 83 micrometers. 9. The nasal spray device of any preceding claim, wherein the sensor has a measurement resolution of about 4 counts per millimeter (mm) to 815 counts per millimeter. 10. The nasal spray device of claim 9, wherein the sensor is configured with a measurement resolution of about 500 counts per millimeter. 11. The nasal spray device of claim 10, wherein the sensor is configured to operate continuously at 10 samples per second at an average power of about 47 microwatts at a measurement resolution of about 500 counts per millimeter. The method according to any one of claims 1 to 11,
The housing further includes 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 mm from the housing interface. The method according to any one of claims 1 to 12,
the sensor is further configured to detect the presence of the vial in the chamber,
wherein the sensor is further configured for automatic calibration in response to insertion of the vial into the chamber. The method according to any one of claims 1 to 13,
the sensor comprising an infrared (IR) proximity sensor configured to detect a change in IR reflectance from the graphical image upon movement of the nozzle relative to the housing;
A nasal spray device, wherein the sensor includes a wide-angle IR light-emitting diode (LED). 15. The nasal spray device of claim 14, wherein the graphic image comprises laser printed ink on paper and/or polyvinyl chloride (PVC) on plastic. 16. The nasal spray device of claim 14 or 15, wherein the IR proximity sensor is configured to detect the presence of the vial in the chamber by distance sensing. 17. The nasal spray device of any one of claims 1 to 16, wherein the sensor comprises a visible light sensor and a visible light source. 18. The nasal spray device of any preceding claim, wherein the sensor is configured to perform a line scan of the graphical image. a nozzle comprising a conical nozzle portion and a housing interface configured to attach to a vial; and
It includes a housing including a chamber sized to accommodate the vial, an opening connected to the chamber, and a sensor,
the housing interface is positioned within the opening and configured to slide through the opening upon movement of the nozzle relative to the housing,
The sensor is configured to detect movement of the housing interface in accordance with movement of the nozzle relative to the housing,
The nasal spray device, wherein the sensor includes at least one of the group consisting of a magnetic field sensor, a capacitive sensor, a resistive sensor, a micro switch, a motion tracking integrated circuit, and a color sensor. An image comprising tapered dark bands interleaved with tapered arcuate bright bands, each of the tapered arcuate dark bands having a low IR reflectance and each of the tapered arcuate bright bands having a high IR reflectance; and
When the IR detector is rotated about the center point of the image, the IR detector remains aligned with the tapered arcuate dark bands and the tapered arcuate bright bands about the image. An infrared (IR) rotation sensor assembly comprising: the IR detector configured to rotate.