HK40057614B - Computerized oral prescription administration for securely dispensing a medication and associated systems and methods - Google Patents

Description

Computerized oral prescription drug delivery and related systems and methods for safe medication dispensing

Cross-references to related applications

This application claims priority and benefit to U.S. Patent Application No. 16/420,002, filed May 22, 2019, the entire contents of which are incorporated herein by reference.

Technical Field

This disclosure generally relates to oral drug dosing devices and computerized oral prescription drug delivery (COPA) devices. For example, a locking cap can be implemented on the vial to prevent unauthorized access to the drug and to facilitate the safe dispensing of the drug only to the intended user.

Background Technology

The history of pharmacology is the history of the continuous development of routes of administration, drug formulations, dosage forms, and dosing devices in an ongoing pursuit of maximizing the efficacy benefits of prescription drugs while reducing relative costs. Administration of prescription substances can take place in a controlled healthcare setting, such as in a healthcare facility or by a physician in a patient's home. Early formulations may include liquid forms for parenteral (e.g., into the bloodstream) and enteral (e.g., into the gastrointestinal tract) administration, including elixirs, tonics, solutions, suspensions, syrups, and final injections, intravenous (IV) injections, and epidural anesthetics. For example, through mechanization and formulation studies, early formulations can be developed to produce advanced forms. Early formulations, advanced forms, and further research and clinical studies (e.g., patient acceptance of early formulations and/or advanced forms) may contribute to the development of routes of administration, drug formulations, dosage forms, and dosing devices.

As healthcare treatment shifts from limited emergency interventions to long-term chronic disease care, a higher percentage of prescription drug administration is moving from controlled healthcare settings to patient-managed settings. In a patient-managed setting, outside the control of trained healthcare personnel, the administration of liquid formulations can be challenging due to non-specific dosing instructions. Dosing based on teaspoon and/or spoon measurements can be ambiguous and variable. Dosing cups may have different measurement formats, potentially causing confusion in a patient-managed setting. Furthermore, dosing cups are often separate from the original prescription bottle, which can lead to incorrect dosing.

Advances in mechanical manufacturing systems and pharmacological research have enabled the transformation of prescription substances for patient-managed dosing from liquid formulations to pellet-like (e.g., tablets or capsules). This can extend shelf life, allow for easier and more accurate dosing for patients, and reduce production costs. Consequently, most oral medications in the patient-managed setting are now pellets. Furthermore, there is growing interest in microparticle formulations, including pellets, granules, microparticles, and microtablets. However, for patients who cannot or do not wish to swallow tablets or capsules, such as infants, the elderly, or patients with disabilities, enteral oral liquid prescriptions can be administered via dosing syringes in the patient-managed setting. Additionally, parenteral liquid formulations remain prevalent in controlled healthcare settings because they typically offer the fastest absorption and most favorable success rates, and can improve local administration, inventory control, fraud prevention, and route of administration auditing capabilities.

Depending on the entity administering the drug, various forms of medicine can be developed to meet the expectations, needs, and challenges of different entities. While there are exceptions based on efficacy and toxicity, most pharmaceutical manufacturers are likely to produce multiple drug formulations to support different routes of administration and dosages.

As consumers become increasingly involved in preventative or outcome-based treatment programs (which involve medication administration in a patient-controlled setting), the demand for medication administration in a patient-controlled or managed setting is growing. For example, the increasing prevalence of major medical procedures, outpatient surgeries, and/or one-day inpatient surgeries may involve subsequent medication administration at the patient's home. Furthermore, the need for prescription management is increasing with an aging population. Consumers may take multiple over-the-counter and/or prescription medications daily, often in pill form. Unfortunately, the ease of use of pills and the growing involvement of consumers in chronic disease management programs have led to misuse and improper administration across many medication categories.

For example, pills are lightweight, portable, have unspecified recipients, are difficult to manage in terms of inventory, do not carry personal identification numbers, have long shelf lives, and are inexpensive to produce. Therefore, pill intake or usage has been difficult to control outside of healthcare administration settings. Furthermore, to achieve economies of scale in manufacturing processes, pill production is arranged to maximize the output of machines, materials, and/or available raw materials, rather than based on future demand. With a few exceptions, a minimal amount of pills produced is wasted because they remain active for extended periods. Pills have proliferated in our society and have become a conduit for addiction and abuse.

Opioid pain management is a patient management approach highly susceptible to prescription abuse and misuse. For example, according to the Food and Drug Administration (FDA), approximately 100 million people in the United States suffer from pain each year. About 900 to 12 million people with pain experience chronic or persistent pain, while the remainder experience short-term pain due to injury, illness, or medical procedures. In 2014, the Centers for Disease Control and Prevention reported that the number of opioid prescriptions in the United States each year was roughly equal to the number of adults in the U.S. population. While people with pain should benefit from skilled and appropriate pain medication, control of opioid abuse or addiction is necessary. FDA leaders and physicians are attempting to address the opioid epidemic by balancing two complementary principles: actively addressing opioid abuse and addiction while protecting the well-being of people experiencing acute or chronic pain. However, in areas where reforms, policies, and restrictions against opioid abuse have been implemented, people with pain may not experience this balance. Some states have implemented additional databases of known addicts or abusers that providers must check before prescribing medication. However, due to the burden of using the system and/or their potential reluctance to restrict medication access for genuinely chronic pain patients, physicians may not check the database before prescribing. Other states have implemented reporting and audit trails to track physicians who prescribe opioid families. However, to avoid additional steps and potential audit reviews, some physicians may refuse to prescribe pain management or short-term pain medication and may refer all cases to a pain clinic.

Attempts to improve patient education, strengthen labeling, and restrict prescriptions have led to increased costs for providers, patients, pharmacies, and insurance companies, while reducing overall effectiveness for patients. Finally, genuine pain sufferers face significant difficulties accessing opioids, and opioid abusers continue to manipulate available access regardless of apparent negligence. Policies and programs at all levels have been unsuccessful and insufficient to control or reduce prescription drug abuse. Therefore, there is a need for improved devices, systems, and methods for drug administration.

Summary of the Invention

The following summarizes some aspects of this disclosure to provide a basic understanding of the techniques discussed. This summary is not a comprehensive overview of all contemplated features of this disclosure, nor is it intended to identify key or critical elements of all aspects of this disclosure, nor to depict the scope of any or all aspects of this disclosure. Its unique purpose is to present some concepts of one or more aspects of this disclosure in summary form as a prelude to the more detailed description that follows.

This disclosure generally relates to oral drug delivery devices and computerized oral prescription drug delivery (COPA) devices. These COPA devices, systems, and methods facilitate the secure dispensing of drugs to intended users. In this regard, the COPA device may be coupled to a housing that may include a drug casing (e.g., a bottle, tube, outer packaging, etc.). The drug casing may include a threaded opening to which a locking cap of this disclosure is secured. To prevent unauthorized access to substances within the drug casing (e.g., drugs, prescription substances, etc.), the drug casing may be coupled to the locking cap. The locking cap may include a component registered to the intended user via a unique identifier. The locking cap can determine whether the intended user is attempting to obtain the drug within the drug casing. In some cases, the drug may only be dispensed if the unique identifier associated with the intended user is verified. Additional verification devices, systems, and methods may also be used to authenticate the intended user. For example, one or more bioassay sensors may be used to detect the bioassay attributes of the intended user to authenticate the intended user.

In one embodiment, a component is provided for securely dispensing a substance to an intended user. The component includes: a first component configured to threadedly engage with a housing containing the substance; a second component coupled to the first component, the second component configured to securely fasten the first component to the housing; a third component including a cavity sized and shaped to selectively receive the second component; and a valve coupled to the first component such that: when the second component is received within the cavity of the third component, the valve is in an open state, the open state allowing dispensing of the substance from the housing to the intended user in response to a processor determining that a unique biometric attribute of the intended user has been detected; and when the second component is not received within the cavity of the third component, the valve is in a closed state, the closed state preventing dispensing of the substance from the housing.

In some embodiments, the component further includes a biasing member configured to bias the valve to a closed state when the second component is not received within the cavity of the third component. In some embodiments, the biasing member is compressed when the second component is received within the cavity of the third component. In some embodiments, the first component includes a plurality of latching members configured to surround a lip of the housing and to prevent the first component from being removed from the housing in an axial direction. In some embodiments, the second component includes a distal portion configured to surround the plurality of latching members to prevent the plurality of latching members from being removed from the lip of the housing in a radial direction. In some embodiments, the plurality of latching members are arranged circumferentially around the periphery of the first component. In some embodiments, the first component includes at least one proximal latching member. In some embodiments, the second component includes at least one latch configured to engage with at least one proximal latching member of the first component to prevent the second component from being removed from the first component in an axial direction. In some embodiments, the valve includes a longitudinal axis, and the second component is configured to rotate about the longitudinal axis of the valve when the second component is coupled to the first component.

In some embodiments, unique biometric attributes include the unique dentition of the intended user. In some embodiments, the component further includes a mouthpiece having a sensor array, through which substance is dispensed from the housing to the intended user's mouth. In some embodiments, the processor is configured to determine that the unique biometric attribute of the intended user is detected by the sensor array. In some embodiments, the second component includes one or more sensors located on an upper surface of the second component, the one or more sensors being configured to provide a unique identifier associated with the intended user. In some embodiments, the third component includes one or more detectors located on a lower surface of the third component, the one or more detectors being configured to contact the one or more sensors of the second component when the second component is received within a cavity of the third component. In some embodiments, the one or more detectors of the third component are configured to communicate with the one or more sensors of the second component to receive a unique identifier associated with the intended user. In some embodiments, the processor is also configured to dispense substance from the housing to the intended user's mouth in response to determining that the one or more detectors have received a unique identifier associated with the intended user.

In one embodiment, a method is provided for securely dispensing a substance to an intended user. The method includes: moving a valve of a locking cap securely attached to a housing containing the substance to an open state allowing the substance to be dispensed from the housing to the intended user; determining a unique biometric attribute of the intended user; and dispensing the substance from the housing to the intended user in response to determining the unique biometric attribute of the intended user.

In some embodiments, the method further includes securely fastening a locking cap to a housing. In some embodiments, securely fastening the locking cap to the housing includes surrounding a lip portion of the housing with a plurality of latching members of a first member of the locking cap, wherein the first member is threadedly engaged with the housing. In some embodiments, securely fastening the locking cap to the housing further includes engaging a second member of the locking cap to the first member of the locking cap. In some embodiments, engaging the second member of the locking cap to the first member of the locking cap includes surrounding a first member with a plurality of latching members of the second member at a distal portion. In some embodiments, moving the valve of the locking cap to an open state includes inserting the second member of the locking cap into a cavity of a third member of the locking cap. In some embodiments, determining that a unique biometric attribute of the intended user is detected includes determining that a unique set of teeth of the intended user is located within a recess of the mouthpiece. In some embodiments, determining that a unique set of teeth of the intended user is located within a recess of the mouthpiece includes using a processor to determine that a unique set of teeth of the intended user is located within a recess of the mouthpiece.

In some embodiments, the method further includes receiving a unique identifier associated with an intended user from one or more sensors of the locking cap using one or more detectors of the locking cap. In some embodiments, dispensing the substance from the casing to the intended user further includes dispensing the substance in response to determining that one or more detectors have received a unique identifier associated with the intended user.

In one embodiment, a system is provided for securely dispensing a substance to an intended user. The system includes a device housing and a locking cap coupled to the device housing. The locking cap includes: a first member configured to threadedly engage with the housing containing the substance; a second member coupled to the first member and configured to securely fasten the first member to the housing; a third member including a cavity sized and shaped to selectively receive the second member; and a valve coupled to the first member such that: when the second member is received within the cavity of the third member, the valve is in an open state allowing dispensing of substance from the housing, and when the second member is not received within the cavity of the third member, the valve is in a closed state preventing dispensing of substance from the housing. The system also includes: a mouthpiece coupled to the device housing, the mouthpiece including a recess; and a processor configured to: determine that a unique set of teeth of an intended user is located within the recess of the mouthpiece; and, in response to determining that a unique set of teeth of an intended user is located within the recess of the mouthpiece, dispensing substance from the housing to the mouth of the intended user.

In some embodiments, the mouthpiece includes a capacitive sensor array configured to acquire data about teeth located within a mouthpiece recess. In some embodiments, the data acquired by the capacitive sensor array includes a capacitance map associated with a intended user. In some embodiments, the processor is further configured to compare a capacitance map associated with a user of the mouthpiece with a predetermined capacitance map associated with a intended user.

Additional aspects, features, and advantages of this disclosure will become apparent from the following detailed description.

Attached Figure Description

Illustrative embodiments of this disclosure will be described with reference to the accompanying drawings, in which:

Figure 1 is a perspective view of a drug casing attached to a device housing according to an embodiment of the present disclosure;

Figure 2 is a cross-sectional view of a locking cap attached to a housing according to an embodiment of the present disclosure;

Figure 3A is a cross-sectional view of a first and second member of a locking cap spaced apart from the housing according to an embodiment of the present disclosure;

Figure 3B is a perspective view of the first and second components of the locking cap according to an embodiment of the present disclosure;

Figure 4A is a cross-sectional view of a first member of a locking cap connected to a housing and a second member of a locking cap connected to the first member, according to an embodiment of the present disclosure.

Figure 4B is a cross-sectional view of a first component of a locking cap connected to a housing and a second component of a locking cap connected to the first component, according to an embodiment of the present disclosure.

Figure 4C is a cross-sectional view of a first component of a locking cap connected to a housing and a second component of a locking cap connected to the first component, according to an embodiment of the present disclosure;

Figure 5A is a cross-sectional view of a third member of a locking cap spaced apart from a second member of the locking cap according to an embodiment of the present disclosure;

Figure 5B is a cross-sectional view of a third member of a locking cap connected to a second member of a locking cap according to an embodiment of the present disclosure;

Figure 5C is a cross-sectional view of a third member of a locking cap connected to a second member of a locking cap according to an embodiment of the present disclosure;

Figure 5D is a top perspective view of a second component of a locking cap connected to a first component of a locking cap according to an embodiment of the present disclosure;

Figure 5E is a top perspective view of a third component of a locking cap connected to a second component of the locking cap according to an embodiment of the present disclosure;

Figure 6A is a front sectional view of the release button of the third component of the locking cap when the third component is connected to the second component of the locking cap according to an embodiment of the present disclosure;

Figure 6B is a side sectional view of the release button of the third component of the locking cap when the third component is connected to the second component of the locking cap according to an embodiment of the present disclosure;

Figure 6C is a side view of the release button of the third component of the locking cap according to an embodiment of the present disclosure;

Figure 6D is a top cross-sectional view of the release button of the third component of the locking cap when the third component is connected to the second component of the locking cap according to an embodiment of the present disclosure;

Figure 7A is a side sectional view of the stop of the third member of the locking cap when the stop is in the unlocked position, according to an embodiment of the present disclosure.

Figure 7B is a side sectional view of the stop of the third member of the locking cap when the stop is in the locked position, according to an embodiment of the present disclosure.

Figure 8 is a flowchart of a method for safely distributing a substance to an intended user according to an embodiment of the present disclosure;

Figure 9 is a cross-sectional view of a first component of a locking cap and a second component of a locking cap connected to a housing according to an embodiment of the present disclosure;

Figure 10A is a cross-sectional view of the first component of the locking cap in an uncompressed state according to an embodiment of the present disclosure;

Figure 10B is a cross-sectional view of the first component of the locking cap in a compressed state according to an embodiment of the present disclosure;

Figure 11A is a side sectional view of a first member connected to a locking cap including a housing of a pump assembly and a second member connected to the locking cap of the first member, according to an embodiment of the present disclosure.

Figure 11B is a front sectional view of a first member connected to a locking cap comprising a housing including a pump assembly and a second member connected to a locking cap of the first member, according to an embodiment of the present disclosure.

Figure 12A is a side sectional view of a locking cap attached to a housing including a pump assembly in an uncompressed state, according to an embodiment of the present disclosure.

Figure 12B is a side sectional view of a locking cap attached to a housing including a pump assembly in a compressed state, according to an embodiment of the present disclosure.

Detailed Implementation

To facilitate understanding of the principles of the invention, reference will now be made to the embodiments shown in the accompanying drawings, which will be described using specific language. However, it should be understood that this disclosure is not intended to limit its scope. Any changes and further modifications to the described apparatus, systems, and methods, as well as any further applications of the principles of this disclosure, are fully conceived and included in this disclosure as would normally occur to those skilled in the art to which this disclosure pertains.

Embodiments of this disclosure provide a mechanism for securely dispensing a substance to an intended user. In one embodiment, a locking cap includes a first member threadedly engageable with a housing (e.g., a medicine bottle) containing the substance. The substance may be a prescription or over-the-counter drug. The locking cap may include a second member coupled to the first member. The second member securely holds the first member to the housing. The locking cap may include a third member including a cavity sized to receive the second member. The second member can be selectively received within the cavity, allowing it to be removed from the cavity after insertion. The locking cap may include a valve connected to the first member. The valve is movable between an open and a closed state. When the second member is received within the cavity of the third member, the valve may be in an open state. The open state allows the substance to be dispensed from the housing to the intended user. The substance may be dispensed to the intended user in response to a processor determining that a unique biometric attribute of the intended user has been detected. When the second member is not received within the cavity of the third member, the valve is in a closed state. The closed state prevents the substance from being dispensed from the housing. The processor may be configured to determine when the second member is received within the cavity of the third member. In one embodiment, the second member may be registered with the intended user.

The disclosed embodiments can provide several benefits. For example, the use of a locking cap ensures that the prescription medication within the casing is delivered only to the intended recipient and is not tampered with. Therefore, the disclosed embodiments can prevent prescription medication misuse (intentional and accidental) and improper administration. The disclosed embodiments can deliver precise doses of prescription medication to patients. This can be particularly beneficial for older adults, people with disabilities, or patients with behavioral problems that may limit their ability to self-administer prescription medication. Furthermore, the use of a locking cap can facilitate providing a single device casing (which may include a locking cap and an attached medication casing) to multiple users (only one intended user is registered to the locking cap at a time). Therefore, the disclosed embodiments can avoid significant manufacturing costs.

Figure 1 is a perspective view of a medication casing 132 attached to a device housing 100 according to an embodiment of the present disclosure. In several embodiments, the device housing 100 is attached to a COPA device 110. The device housing 100 includes a release button 120. The medication casing 132 may be attached to the device housing 100 via a locking cap 130. The size and shape of the device housing 100 may be suitable for handheld use. For example, the device housing 100 may be structurally arranged to be gripped by a user with one hand by placing the user's fingers and palm around the device housing 100. The device housing 100 may have any suitable shape, such as a cylinder, a right-angled prism, a cube, portions thereof, and/or any combination thereof. In some embodiments, the device housing 100 includes a removable back cover covering the medication casing 132. In such embodiments, the back cover may also cover the release button 120, such that the release button 120 is only accessible when the back cover is removed from the device housing 100. In some examples, the back cover may be transparent so that the drug label on the drug casing 132 is visible when the back cover is attached to the device housing 100.

The back cover can be removed to allow an authorized person, such as a pharmacist, access to the drug casing 132 and to refill and/or replace it as needed. In some embodiments, to remove the back cover, the authorized person can unlock it from the device housing 100. The authorized person can then remove the empty drug casing 132 from the device housing 100 by pressing the release button 120. In some embodiments, the authorized person can refill the drug casing 132 with prescription material and place it back into the device housing 100. After placing the drug casing 132 inside the device housing 100, the authorized person can lock the back cover onto the device housing 100.

In some embodiments, the COPA device 110, which may include a mouthpiece, may have one or more sensors or sensor arrays for detecting the unique dentition of a intended user. In some examples, the mouthpiece sensors may include a capacitive sensor array. The capacitive sensor array may be configured to detect a capacitance map associated with detected input from the current user of the COPA device 110. The capacitance map may be associated with the dentition of the current user of the COPA device 110. In some examples, the capacitance map is associated with the unique dentition of the intended user. The processor may determine whether the unique dentition of the intended user is located within a recess of the COPA device 110. For example, the processor may compare the capacitance map associated with detected input from the current user of the COPA device 110 with a predetermined capacitance map associated with the unique dentition of the intended user. Based on this comparison, the processor determines whether there is a match between the current user of the COPA device 110 and the intended user of the COPA device 110. If a match is found, the processor may dispense a substance from the drug casing 132 to the intended user. In some embodiments, the processor is included in the device casing 100. In alternative embodiments, the processor is included in the COPA device 110. In another alternative embodiment, the processor is included in a system separate from the device housing 100 and the COPA device 110.

Further details regarding the device housing 100 and the COPA device 110 can be found in U.S. Patent Application No. 15/406,043 (now U.S. Patent No. 9,731,103), filed January 13, 2017; U.S. Patent Application No. 15/674,046 (now U.S. Patent No. 10,188,840), filed August 10, 2017; U.S. Patent Application No. 15/708,045 (now U.S. Patent No. 9,981,116), filed September 18, 2017; U.S. Patent Application No. 15/958,809, filed April 29, 2018; U.S. Patent Application No. 16/001,498, filed June 6, 2018; and U.S. Patent Application No. 16/246,122, filed January 11, 2019, all of which are incorporated herein by reference in their entirety.

Figure 2 is a cross-sectional view of a locking cap 130 coupled to a drug casing 132 according to an embodiment of the present disclosure. The drug casing 132 includes threads 136 and a lip 138. The locking cap 130 includes a first member 140, a second member 160, and a third member 170. The first member 140 includes a groove 142 corresponding to the threads 136 of the casing 132. The groove 142 receives the threads 136. In this way, the first member 140 and the casing 132 can be threadedly coupled. The first member 140 also includes an upper edge 144, a lower edge 146, at least one latching member 148, a lower protrusion 150 corresponding to each latching member 148, a recess 152 defined by the upper edge 144 and the lower edge 146, a flange 154, and at least one upper protrusion 156, which may also be referred to as a proximal latching member. In some embodiments, the second member 160 includes at least one upper protrusion 162 corresponding to the upper protrusion 156 of the first member 140. The second component 160 also includes a distal portion 164 and a circuit board 210. In some embodiments, the circuit board 210 may be coupled to one or more sensors or a sensor array. In alternative embodiments, the sensors may be integrated within the circuit board 210.

In some embodiments, the third component 170 includes a release button 120. In alternative embodiments, the third component 170 may be included as part of the device housing 100. The third component 170 also includes a circuit board 200 located on its top surface (which may be the upper surface). In some embodiments, the circuit board 200 may be coupled to one or more detectors or a detector array. In alternative embodiments, the detector may be integrated within the circuit board 200. In some examples, the detector communicates with a sensor of the second component 160. The processor may use data acquired by the sensor to determine whether the second component 160 is coupled to the third component 170. In some embodiments, the second component 160 is coupled to the third component 170 when it is received within the cavity of the third component 170, as will be discussed in further detail below.

In some embodiments, the locking cap 130 includes a valve assembly 180. The valve assembly 180 includes a valve 182, a biasing member 184, and a fluid connector 190. In some embodiments, the valve assembly 180 includes a check valve. It should be understood that the valve assembly 180 may include any other suitable type of valve, such as a ball valve, diaphragm valve, ball valve, needle valve, gravity valve, duckbill valve, etc. In some embodiments, the biasing member 184 is a spring. In other embodiments, the biasing member 184 may be any other suitable type of component configured to bias the valve 182 in a particular direction. In some examples, the biasing member 184 biases the valve 182 to a closed state when the second component 160 is not received within the cavity 172 of the third component 170. The valve assembly 180 may be integrally formed as part of the first component 140. In other embodiments, the valve assembly 180 may be a separate component received within and coupled to the first component 140. As shown in the embodiment of Figure 2, the valve assembly 180 is received within the first member 140 and connected to the draw tube 134. The draw tube 134 is located within the housing 132 and is used to deliver a substance, which may be a prescription substance, from the housing 132 to the intended user.

In some embodiments, the third component 170 includes a coupling component 220 to couple the valve assembly 180 to the device housing 100. As shown in the embodiment of FIG2, a fluid connector 190 of the valve assembly 180 is coupled to the coupling component 220. Also shown in the embodiment of FIG2, the coupling component 220 is coupled to the pump 230. In some embodiments, the pump 230 is included as part of the device housing 100. Thus, in some embodiments, the coupling component 220 facilitates a connection between the locking cap 130 and the device housing 100 via the pump 230. This connection allows the prescription substance to be dispensed from the housing 132, through the valve assembly 180, and through the pump 230 to the intended user. In some examples, the prescription substance is also dispensed via the COPA device 110 before reaching the intended user. In such examples, the prescription substance is dispensed into the intended user's mouth.

Figure 3A is a cross-sectional view of a first member 140 and a second member 160 spaced apart from the housing 132 according to an embodiment of the present disclosure. Figure 3B is a perspective view of the first member 140 and the second member 160 according to an embodiment of the present disclosure. As shown in the embodiment of Figure 3B, latching members 148 are arranged circumferentially around the periphery of the first member 140. Each latching member 148 may be spaced apart by a gap to provide greater mobility and convenience for each latching member 148. For example, when the first member 140 is engaged with the housing 132, each latching member 148 may move and bend independently of the other latching members 148. In some embodiments, the first member 140 includes eight latching members 148, as shown in Figure 3B. However, it should be understood that the first member 140 may include any other desired number of latching members, which may be fewer than or more than eight. In an alternative example, the first member 140 may include a single continuous latching member 148 without any gaps, extending around the periphery of the first member 140.

In some embodiments, the flange 154 of the first member 140 is positioned very close to the latching member 148. For example, the flange 154 may be positioned at the junction where the latching member 148 connects to the body 155 of the first member 140. As shown in the embodiment of FIG3B, the upper edge 144 and the lower edge 146 are spaced apart from the flange 154. In an alternative embodiment, the flange 154 may be spaced apart from the latching member 148, and the flange 154 may be very close to the lower edge 146. In some embodiments, the first member 140 further includes an upper lip 157 and a lower lip 159. The upper lip 157 and the lower lip 159 are spaced apart from each other such that a locking groove 158 is defined between the upper lip 157 and the lower lip 159. In some embodiments, the upper lip 157 is aligned with the upper edge 144, and the lower lip 159 is aligned with the lower edge 146. The upper edge 144 and the lower edge 146 may together form a locking ring. The locking ring may include one or more locking recesses 158. In some examples, as shown in the embodiment of FIG3A, the first member 140 includes two locking recesses 158. In several examples, the second member 160 includes locking protrusions 166, which are sized and shaped to fit within the locking recesses 158. The second member 160 may include as many locking protrusions 166 as the locking recesses 158, such that each locking recess 158 receives a corresponding locking protrusion 166. In some examples, the locking ring may include the required and/or desired number (e.g., one, two, three, four, etc.) of locking recesses 158.

In some embodiments, the second member 160 is coupled to the first member 140 by first pushing the second member 160 onto the first member 140 such that each locking protrusion 166 of the second member 160 travels over a corresponding upper lip 157 and is received by a corresponding locking groove 158 of the first member 140. When the locking protrusions 166 are within the locking grooves 158, the second member 160 is in a first position relative to the first member 140. In some embodiments, when the second member 160 is in the first position relative to the first member 140, the second member 160 and the first member 140 are rotationally locked relative to each other. Therefore, when the second member 160 rotates, the first member 140 rotates with the second member 160. Thus, to attach the first member 140 to the housing 132, the first member 140 is placed on top of the housing 132. The second member 160 can then be rotated (e.g., clockwise or counterclockwise) to screw the first member 140 onto the housing 132. In an alternative embodiment, the first component 140 may be screwed onto the housing 132 without being connected to the second component 160. In such an embodiment, the second component 160 may be connected to the first component 140 after the first component 140 is connected to the housing 132.

Figure 4A is a cross-sectional view of a first member 140 coupled to a housing 132 and a second member 160 coupled to the first member 140 according to an embodiment of the present disclosure. In some embodiments, the second member 160 is rotated until the lower protrusion 150 of each latching member 148 of the first member 140 passes over and engages with the lip 138 of the housing 132. In such embodiments, the lower protrusion 150 engages with the lip 138 by resting below and/or contacting the bottom of the lip 138. In this position, the first member 140 is securely fixed to the housing 132 in a longitudinal direction (e.g., a direction generally parallel to the longitudinal axis L of the biasing member 184 of the valve assembly 180). The longitudinal direction may also be referred to as the axial direction. After the first member 140 is securely fixed to the housing 132, the second member 160 can be moved to a second position in which the second member 160 is securely fixed to the first member 140.

Figure 4B is a cross-sectional view of a first member 140 and a second member 160 connected to a housing 132 according to an embodiment of the present disclosure. In the embodiment shown in Figure 4B, the second member 160 is in a second position relative to the first member 140. As shown, the upper protrusion 162 has passed over and engaged with the upper protrusion 156 of the first member. Therefore, the second member 160 is securely fixed to the first member 140 in the longitudinal direction, which may also be referred to as the axial direction and is generally parallel to the longitudinal axis L. Further as shown in the embodiment of Figure 4B, the distal portion 164 of the second member 160 surrounds the latching member 148 of the first member 140. Therefore, the first member 140 is securely fixed to the housing 132 in the radial direction, which may be a direction generally perpendicular to the longitudinal axis L. Thus, in some examples, when the second member 160 is in the second position relative to the first member 140, the first member 140 is securely fixed to the housing 132 in both the longitudinal and radial directions. In such an example, the first component 140 and the second component 160 can be irreversibly and firmly engaged with the housing 132. Therefore, the only way to remove the first component 140 or the second component 160 from the housing 132 is to destroy one or more segments of the locking cap 130. The first component 140 and the second component 160 can be irreversibly and firmly engaged with the housing 132 in one or both of the longitudinal and radial directions.

Figure 4C is a cross-sectional view of a first member 140 connected to a housing 132 and a second member 160 according to an embodiment of the present disclosure. In some embodiments, when the second member 160 is in a second position relative to the first member 140, a locking protrusion 166 of the second member 160 is positioned between the lower lip 159 and the flange 154. Therefore, in order to move from the first position to the second position, the second member 160 is pushed along a direction L1 that is generally parallel to the longitudinal axis L. As the second member 160 moves from the first position to the second position, the locking protrusion 166 moves from a state within the locking recess 158 to a state between the lower lip 159 and the flange 154. During this transition from the first position to the second position, the locking protrusion 166 travels across and past the lower lip 159.

In several examples, the distal portion 164 of the second member 160 is made of a material that is harder and/or more rigid than the latching member 148 of the first member 140. Therefore, the distal portion 164 restricts and/or accommodates any attempted radial movement of the latching member 148. Radial movement may occur if a user attempts to remove the first member 140 from the housing 132. In some embodiments, when the second member 160 is in a second position relative to the first member 140, the second member 160 and the first member 140 are no longer rotationally locked relative to each other. Therefore, in such embodiments, the second member 160 can rotate freely about the first member 140. When the housing 132 is attached to the device housing 100, the authorized person can, for example, rotate the housing 132 to a position where the information label of the housing 132 faces the rear cover of the device housing 100. In this position, the user can read the information label while the housing 132 is locked within the device housing 100. The information label may include information about a prescription substance, such as the type of substance, the amount of substance, dosage instructions, etc.

Figure 5A is a cross-sectional view of a third member 170 of a locking cap 130 spaced apart from the second member 160 according to an embodiment of the present disclosure. The third member 170 includes a cavity 172 in which the second member 160 is received. In some embodiments, the cavity 172 is shaped such that the diameter of the cavity 172 is slightly larger than the outer diameter of the second member 160. In such embodiments, the second member 160 can be fitted into the cavity 172 of the third member 170 such that a fluid-impermeable seal is formed between the second member 160 and the third member 170. In other embodiments, the cavity 172 is sized such that a gap exists between the second member 160 and the third member 170 when the second member 160 is received within the cavity 172.

In several examples, valve 182 can switch between an open state and a closed state. When valve 182 is in the open state, it allows dispensing of a prescription substance from housing 132 to the intended user. In some embodiments, the prescription substance may be dispensed in response to a processor determining that a unique bioassay attribute of the intended user has been detected, which will be discussed in further detail below. When valve 182 is in the closed state, it prevents dispensing of the prescription substance from housing 132. In some examples, valve 182 is in the closed state when the second member 160 is not received within the cavity 172 of the third member 170. In such an example, valve 182 is in the open state when the second member 160 is received within the cavity 172. In some embodiments, biasing member 184 biases valve 182 to the closed state. However, when the second member 160 is received within the cavity 172 of the third member 170, coupling member 220 contacts valve 182. In some embodiments, this connection overcomes the biasing force exerted on valve 182 by biasing member 184. The biasing member 184 can be compressed as the valve 182 moves from the closed state to the open state. As shown in the embodiment of FIG5A, the second member 160 is not received within the cavity 172, so the connecting member 220 does not contact the valve 182. Therefore, in the embodiment shown in FIG5A, the valve 182 is in the closed state.

Figure 5B is a cross-sectional view of a third member 170 connected to the second member 160 according to an embodiment of the present disclosure. In the embodiment shown in Figure 5B, the second member 160 is housed within a cavity 172 of the third member 170, and the valve 182 is in the open state. It can be seen that the connecting member 220 is in contact with the valve 182, and the biasing member 184 is compressed. Therefore, the valve 182 has moved in direction L1 and is capable of dispensing the prescription substance from the housing 132. For example, a pump 230 can dispense the prescription substance from the housing 132.

Figure 5C is a cross-sectional view of a third component 170 coupled to a second component 160 according to an embodiment of the present disclosure. The cross-sectional view of Figure 5C is rotated approximately 15 degrees relative to the cross-sectional view of Figure 5B. The third component 170 includes a contact member 174 for contacting circuit boards 200 and 210. In several examples, the contact member 174 remains in contact with circuit board 200 regardless of whether the second component 160 is coupled to the third component 170. The contact member 174 facilitates communication between components of circuit boards 200 and 210. In some embodiments, a unique identifier associated with an intended user can be transmitted from a transceiver of the second component 160 to a transceiver of the third component 170. The transceiver of the second component 160 may be connected to circuit board 210. The transceiver of the third component 170 may be connected to circuit board 200. In some embodiments, the unique identifier may be stored in memory. As shown in the embodiment of Figure 5C, when the second component 160 is received within the cavity 172 of the third component 170, the contact member 174 contacts circuit board 210.

Figure 5D is a top perspective view of a second component 160 coupled to a first component 140 according to an embodiment of the present disclosure. The second component 160 includes a sensor array 240 positioned on its top surface 244, which may include one or more sensors. In some embodiments, the sensor array 240 is coupled to a circuit board 210. In other embodiments, the sensor array 240 is integrated within the circuit board 210. As shown in the embodiment of Figure 5D, the sensor array 240 includes four individual sensors 242. The sensors 242 are programmed to provide a unique identifier associated with an intended user. Therefore, the second component 160 can be registered to an intended user. Thus, in some embodiments, when the second component 160, registered to an intended user, is coupled to the first component 140, the intended user will only be able to access the prescription substance within the housing 132. In several examples, each sensor 242 is used to provide a unique identifier. In other examples, only one sensor 242 is used to provide a unique identifier. However, in some embodiments, one or more sensors 242 may be provided to indicate whether a third component 170 is coupled to the second component 160. In such embodiments, one or more sensors 242 may not be included in the unique identifier associated with the intended user. It should be understood that the sensor array 240 may include any number of sensors 242 to provide a unique identifier associated with the intended user. For example, the sensor array 240 may include fewer than or more than four sensors 242.

As shown in the embodiment of Figure 5D, the second member 160 also includes an opening 246 in its top surface 244. In several examples, a valve 182 is fitted within the opening 246. Thus, when the second member 160 is received within the cavity 172 of the third member 170, the valve 182 can be contacted by the coupling member 220. In such an embodiment, the valve 182 can be moved from a closed state to an open state. The placement of the valve 182 within the opening 246 also prevents access to the prescription substance within the drug casing 132. For example, a user might not place a needle or other object through the opening 246 and access the prescription substance. Therefore, access to the prescription substance is prevented even when the casing 132 is not coupled to the device casing 100.

The second component 160 also includes guide ribs 168a and 168b. When the second component 160 is received within the cavity 172 of the third component 170, the guide ribs 168a and 168b are sized to fit within corresponding guide channels of the third component 170. The guide ribs 168a and 168b ensure that when the second component 160 and the third component 170 are joined together, they will be engaged in the same rotational position. This ensures that the sensor array 240 will be aligned with the corresponding detector array 250 of the third component 170.

Figure 5E is a top perspective view of a third member 170 coupled to a second member 160 according to an embodiment of the present disclosure. The third member 170 includes a detector array 250, which may include one or more detectors positioned on a bottom surface of the third member 170, which may be a lower surface. In some embodiments, the detector array 250 is coupled to a circuit board 200. In other embodiments, the detector array 250 is integrated within the circuit board 200. As shown in the embodiment of Figure 5E, the detector array 250 includes four individual detectors 252. The detectors 252 are positioned such that when the second member 160 is received by the third member 170, the detectors 252 are aligned with sensors 242 of a sensor array 240. In some embodiments, the detectors 252 are programmed to receive a unique identifier associated with an intended user from the sensors 242 of the sensor array 240. In several examples, each detector 252 is used to receive a unique identifier. In other examples, only one detector 252 is used to receive a unique identifier. However, in some embodiments, one or more detectors 252 may be provided to detect whether the third component 170 is connected to the second component 160. In such embodiments, one or more detectors 252 may not be included in the unique identifier associated with the intended user. It should be understood that the detector array 250 may include any number of detectors 252 to receive the unique identifier of the intended user. For example, the detector array 250 may include fewer than or more than four detectors 252. In some embodiments, the number of detectors 252 in the detector array 250 is equal to the number of sensors 242 in the sensor array 240.

Figure 6A is a front sectional view of the release button 120 of the locking cap 130 when the third member 170 is engaged with the second member 160 according to an embodiment of the present disclosure. The release button 120 includes a locking protrusion 122. The locking protrusion 122 extends toward the second member 160 in direction D1. Furthermore, in some embodiments, the locking protrusion 122 is located below at least one of the guide ribs 168a, 168b of the second member 160. For example, the locking protrusion 122 may be positioned below guide rib 168a instead of guide rib 168b. Thus, when the second member 160 is received within the cavity 172 of the third member 170, the locking protrusion 122 prevents the second member 160 from being removed from the cavity 172 before the release button 120 is pressed, as will be described in further detail below. In an alternative embodiment, the locking protrusion 122 may be positioned below guide rib 168b instead of guide rib 168a. In another example, the locking protrusion 122 may be positioned below both guide ribs 168a, 168b.

Figure 6B is a side sectional view of the release button 120 when the third member 170 is engaged with the second member 160 according to an embodiment of the present disclosure. As described above, when the second member 160 is received within the cavity 172 of the third member 170, the release button 120, particularly the locking protrusion 122, is positioned below at least one of the guide ribs 168a, 168b of the second member 160. In the embodiment shown in Figure 6B, the locking protrusion 122 is located below the guide rib 168a.

As shown in the embodiment of Figure 6B, the release button 120 also includes a proximal protrusion 129 and a biasing member 124. In some embodiments, the biasing member 124 is a spring. In other embodiments, the biasing member 124 can be any other suitable type of component configured to bias the release button 120 in a particular direction. In some embodiments, the third member 170 includes a sealing member 126, a cavity 176, and at least one protrusion 178. The sealing member 126 provides a liquid-proof seal to prevent liquid from entering the cavity 176. The liquid-proof cavity 176 allows the release button 120 to function properly and reduces the chance of failure. As will be discussed in further detail below, when the release button 120 is pressed, the biasing member 124 is compressed. This allows the second member 160 to be removed from the cavity 172 of the third member 170. When the release button 120 is pressed, the release button 120 moves in a direction A1, which is generally parallel to the longitudinal axis A of the biasing member 124. In some embodiments, the biasing member 124 may bias the release button 120 along direction A2 such that the proximal protrusion 129 of the release button 120 contacts the protrusion 178 of the third member 170.

Figure 6C is a side view of a release button 120 according to an embodiment of the present disclosure. The release button 120 also includes a tapered surface 128. In some embodiments, as the second member 160 is inserted into the cavity 172 of the third member 170, a guide rib 168a contacts the tapered surface 128. As the second member 160 is further inserted into the cavity 172, the guide rib 168a travels along the tapered surface 128, causing the release button 120 to move in direction A1. In some examples, the guide rib 168a passes over the tapered surface 128 of the release button 120 when the second member 160 is fully inserted into the cavity 172. In such examples, the guide rib 168a is positioned above the release button 120. As the guide rib 168a passes over the tapered surface 128 and moves above the release button 120, the biasing member 124 moves the release button 120 back to the locked position shown in the embodiment of Figure 6B. In the locked position, the proximal protrusion 129 of the release button 120 contacts the protrusion 178 of the third member 170. The presence of the tapered surface 128 allows the second member 160 to be inserted into the cavity 172 of the third member 170 without actively pressing the release button 120.

Figure 6D is a top cross-sectional view of the release button 120 in the unlocked position according to an embodiment of the present disclosure. When the release button 120 is pressed, it is in the unlocked position. When the release button 120 is pressed, the bias member 124 is compressed. Therefore, the release button 120 moves along direction A1. As the release button 120 moves along direction A1, the locking protrusion 122 moves along direction A1. In some embodiments, when the release button 120 reaches the final unlocked position, as shown in the embodiment of Figure 6D, the locking protrusion 122 is located within the cavity 176. In such an embodiment, the locking protrusion 122 is no longer located below the guide rib 168a. Therefore, the locking protrusion 122 no longer prevents the second member 160 from being removed from the cavity 172. Therefore, the second member 160 can be removed from the cavity 172.

Figure 7A is a side sectional view of the stop 300 of the third member 170 when the stop 300 is in the unlocked position, according to an embodiment of the present disclosure. The stop 300 includes a proximal portion 302, a proximal protrusion 304, a distal portion 306, and a biasing member 308. In some embodiments, the biasing member 308 is a spring. In other embodiments, the biasing member 308 may be any other suitable type of component configured to bias the stop 300 in a particular direction. In some embodiments, when the stop 300 is pressed and moved in direction L1, the proximal protrusion 304 engages the biasing member 308. This can cause the biasing member 308 to compress. In some embodiments, the stop 300 can be pressed down by pushing down on the proximal portion 302. In some examples, a motor, solenoid, mechanical linkage, or any other suitable component may be used to push the proximal portion 302 of the stop 300 in direction L1 to press the stop 300.

Figure 7B is a side sectional view of the stop 300 of the third member 170 when the stop 300 is in the locked position according to an embodiment of the present disclosure. The stop 300 is in the locked position when the distal portion 306 of the stop 300 enters the cavity 176. In some embodiments, the stop 300 can be moved to the locked position after the second member 160 is received and locked within the cavity 172 of the third member 170. In the locked position, the distal portion 306 prevents the proximal protrusion 129 from moving in direction A1, as the proximal protrusion 129 would contact the distal portion 306 of the stop 300. Therefore, the locking protrusion 122 of the release button 120 will remain below the guide rib 168a. Thus, removal of the second member 160 from the cavity 172 of the third member 170 can be prevented. The stop 300 can be moved to the locked position to prevent the release button 120 from being pressed when dispensing prescription substances from the housing 132. This helps ensure that the prescription substances are dispensed correctly (e.g., at the correct dosage). This can also help prevent unauthorized access to prescription substances, adding further security to the locking cap 130. In some embodiments, the stop 300 can be actively held in the locked position by means of a component for pressing the stop 300. In other embodiments, the stop 300 can be held in the locked position by a locking mechanism (e.g., a mechanical lock, an electromagnetic lock, etc.).

Figure 8 is a flowchart of a method 400 for safely dispensing a substance to an intended user according to an embodiment of the present disclosure. Method 400 can be better understood with reference to Figures 1 and 5A-E. As shown, method 400 includes a plurality of enumerated steps, but embodiments of method 400 may include additional steps before, after, and between the enumerated steps. In some embodiments, one or more of the enumerated steps may be omitted or performed in a different order.

In step 402, method 400 includes moving a valve of a locking cap securely attached to a housing containing substance to an open state that allows substance to be dispensed from the housing to an intended user. In some embodiments, the locking cap is locking cap 130, and the housing is housing 132. In such embodiments, the valve is valve 182. In some examples, method 400 may additionally include the step of securely attaching locking cap 130 to housing 132. In some embodiments, securely attaching locking cap 130 to housing 132 may include surrounding a lip 138 of housing 132 with a plurality of latching members 148 of a first member 140 of locking cap 130. In other embodiments, securely attaching locking cap 130 to housing 132 may include engaging a second member 160 of locking cap 130 to first member 140. In some examples, engaging second member 160 to first member 140 includes surrounding a plurality of latching members 148 with a distal portion 164 of second member 160. In several examples, moving valve 182 to the open state includes inserting second member 160 into cavity 172 of third member 170.

In step 404, method 400 includes determining that a unique biometric attribute of the intended user is detected. In some embodiments, the processor may determine whether the unique biometric attribute of the intended user is located on a biometric sensor. The biometric sensor may be located on a surface of the device housing 100. For example, the processor may compare a fingerprint model associated with an input to the biometric sensor with a predetermined fingerprint model associated with the intended user to determine whether there is a match between the current user of the device housing 100 and the intended user of the device housing 100. In some cases, the biometric sensor detects the user's unique biometric attribute when it is located on the biometric sensor. In other examples, the biometric sensor detects the user's unique biometric attribute when it is spaced from the biometric sensor. In other embodiments, the determination includes determining that the intended user's unique dentition is located within a recess of the mouthpiece (e.g., COPA device 110). In such embodiments, this may include the processor determining that the intended user's unique dentition is located within a recess of the mouthpiece. In some embodiments, a capacitive sensor array may be positioned within a recess of the mouthpiece. In several embodiments, the capacitive sensor array can detect a capacitive map associated with the teeth of the current user of the mouthpiece. In some examples, the processor can compare the capacitive map associated with the current user of the mouthpiece with a predetermined capacitive map associated with a prospective user. Further details regarding the COPA device 110 can be found in U.S. Patent Application No. 15/958,809, filed April 29, 2018, which is incorporated herein by reference in its entirety.

In step 406, method 400 includes dispensing a substance from the casing to the intended user in response to determining that a unique biometric attribute of the intended user has been detected. In some embodiments, dispensing includes dispensing the substance in response to the processor determining that a unique set of teeth of the intended user is located within a recess of the mouthpiece. In other embodiments, dispensing includes dispensing the substance, either alone or additionally, in response to the processor determining that a unique identifier of the second component 160 associated with the intended user is detected by the detector array 250 of the third component 170. In several examples, this determination may include receiving the unique identifier associated with the intended user by the detector array 250. The detector array 250 may receive the unique identifier associated with the intended user from the sensor array 240 of the second component 160.

Figure 9 is a cross-sectional view of a first member 510 and a second member 520 of a locking cap 500 connected to a housing 132 according to an embodiment of the present disclosure. The discussion above with respect to Figures 1-8 applies similarly to the embodiment of Figure 9. Any differences between the components discussed above and those shown in the embodiment of Figure 9 will now be discussed.

In an alternative embodiment, the locking cap 500 may be received within the device housing 100 to securely dispense prescription substances from the housing 132. The locking cap 500 includes a first member 510 and a second member 520. The first member 510 includes a groove 512 corresponding to a thread 136 of the housing 132. The groove 512 receives the thread 136. In this way, the first member 510 and the housing 132 can be threadedly connected. The second member 520 includes a lower protrusion 522. In some embodiments, as discussed above with respect to the locking cap 130, the first member 510 rotates together with the second member 520 when the second member 520 is rotated. Therefore, to attach the first member 510 to the housing 132, the first member 510 is positioned on top of the housing 132. The second member 520 may be rotated (e.g., clockwise or counterclockwise) to screw the first member 510 onto the housing 132. In some embodiments, the second member 520 is rotated until the lower protrusion 522 of the second member 520 passes over and engages with the lip 138 of the housing 132. Thus, the second member 520 can be securely fixed to the housing 132 (e.g., in the axial direction). The second member 520 can then be received within the cavity 172 of the third member 170 as described above.

Figure 10A is a cross-sectional view of the locking cap 600 in an uncompressed state according to an embodiment of the present disclosure. The discussion above with respect to Figures 1-8 is similarly applicable to the embodiments of Figures 10A and 10B. Any differences between the components discussed above and those shown in the embodiments of Figures 10A and 10B will now be discussed.

In an alternative embodiment, the locking cap 600 may be received within the device housing 100 to securely dispense prescription substances from the housing 132. The locking cap 600 includes a stop 610, an elongated threaded member 620, a compression member 630, and a threaded nut 640. The elongated threaded member 620 includes a thread 622 and a longitudinal axis LA. The threaded nut 640 includes a groove 642 corresponding to and receiving the thread 622. Thus, the elongated threaded member 620 and the threaded nut 640 can be threadedly engaged. In some embodiments, the compression member 630 can be switched between a non-compressed state and a compressed state. When the compression member 630 is in the non-compressed state as shown in the embodiment of FIG. 10A, the locking cap 600 can be inserted into and removed from the housing 132. In some embodiments, to switch the compression member 630 from a non-compressed state to a compressed state, the threaded nut 640 is rotated about the longitudinal axis LA.

Figure 10B is a cross-sectional view of a locking cap 600 in a compressed state according to an embodiment of the present disclosure. As the threaded nut 640 rotates, the threaded nut 640 moves an elongated threaded member 620 upward in a direction LA1 generally parallel to the longitudinal axis LA. As the threaded nut 640 moves in the direction LA1, the compression member 630 compresses until it rests on the inner surface 650 of the housing 132. In several examples, the interaction between the compression member 630 and the inner surface 650 of the housing 132 forms a seal that prevents the locking cap 600 from being removed from the housing 132. Then, in some embodiments, the locking cap 600 may be received within a third member 170. In other embodiments, a second member 160 may be placed on top of the locking cap 600. In such an embodiment, the second member 160 may surround the housing 132. Then, in such an embodiment, the second member 160 may be received by the third member 170.

Figure 11A is a side sectional view of a first member 740 coupled to a housing 132 including a pump assembly 730 and a second member 760 coupled to the first member 740, according to an embodiment of the present disclosure. The discussion above with respect to Figures 1-8 is similarly applicable to the embodiments of Figures 11A and 11B. Any differences between the components discussed above and those shown in the embodiments of Figures 11A and 11B will now be discussed.

In an alternative embodiment, the locking cap 700 includes a first member 740, a second member 760, a valve 710, and a pump assembly 730. The valve 710 includes a longitudinal axis V, a valve stem 712, a shaft 714, a biasing member 716, and a cam 718. The pump assembly 730 includes a cam follower 732, an upper member 734, a lower member 736, and a biasing member 738. Thus, as shown in the embodiment of FIG11A, the housing 132 includes a valve (e.g., valve 710) and a pump (e.g., pump assembly 730). In some embodiments, it may be advantageous to include both the valve and the pump within the housing 132 because any residual amount of the prescription substance remaining in the fluid passage after a dose of the prescription substance has been dispensed during a pump cycle will be contained within the housing 132. For example, if the pump assembly 730 is included outside the housing 132, residual amount of the prescription substance may remain outside the housing 132 (e.g., within the pump assembly 730) after a dose of the prescription substance has been dispensed during a pump cycle.

In some embodiments, the first component 740 functions the same as the first component 140. Additionally, the structure of the first component 740 may be the same as that of the first component 140. In other embodiments, the structure of the first component 740 may differ from that of the first component 140. In some embodiments, the second component 760 functions the same as the second component 160. Additionally, the structure of the second component 760 may be the same as that of the second component 160. In other embodiments, the structure of the second component 760 may differ from that of the second component 160.

In some examples, the biasing member 716 biases the valve 710 in a closed position, which may be a position that prevents the dispensing of prescription substance from the housing 132. In some embodiments, the biasing member 716 is a spring. In other embodiments, the biasing member 716 may be any other suitable type of component configured to bias the valve 710 in a particular direction. The valve stem 712 is sized and shaped to engage with the third member 770, which will be discussed in more detail below. The shaft 714 is configured to freely move into and out of the cam 718. In the embodiment shown in FIG11A, the biasing member 716 is compressed when the valve stem 712 is pushed in a direction V1 that may be generally parallel to the longitudinal axis V. Thus, the valve 710 moves from the closed position to the open position. However, simply pushing the valve stem 712 in the direction V1 does not cause the dispensing of prescription substance from the housing 132. Although pushing the valve stem 712 in the direction V1 opens the valve 710, the prescription substance is not dispensed unless and until the valve 710 is also rotated, which will be discussed in further detail below.

Figure 11B is a front sectional view of a first member 740 of a locking cap 700 coupled to a housing 132 and a second member 760 of the locking cap 700 coupled to the first member 740, according to an embodiment of the present disclosure. The valve 710 also includes a stop member 720 and a plurality of protrusions 722. In some embodiments, the protrusions 722 mark a lower limit of the vertical travel of the shaft 714. For example, as the shaft 714 travels in direction V1, the stop member 720 of the valve 710 contacts the protrusions 722 and stops the vertical movement of the shaft 714. In several embodiments, the protrusions 722 stop the vertical movement of the shaft 714 before the shaft 714 would cause the pump assembly 730 to open and begin dispensing prescription substances from the housing 132.

Figure 12A is a side sectional view of a locking cap 700 including a pump assembly 730 in a non-compressed state according to an embodiment of the present disclosure. Figure 12B is a side sectional view of a locking cap 700 coupled to a housing 132 including a pump assembly 730 in a compressed state according to an embodiment of the present disclosure. In the embodiment of Figure 12A, a second member 760 is received within a cavity 172 of a third member 770. In this embodiment, the third member 770 engages a valve stem 712. For example, a coupling member 220 may engage the valve stem 712. In several embodiments, when the third member 770 engages the valve stem 712, the third member 770 moves the valve 710 from a closed position to an open position. In some embodiments, the third member 770 performs the same function as the third member 170. Additionally, the structure of the third member 770 may be the same as that of the third member 170. In other embodiments, the structure of the third member 770 may differ from that of the third member 170.

As described above, in order to dispense prescription substances from housing 132, valve 710 can be moved to the open position and also rotated. In some embodiments, valve 710 can be rotated by rotating a third member 770. This rotation can cause coupling member 220 to rotate. Valve 710 can then rotate accordingly with coupling member 220. In some embodiments, when valve 710 rotates, shaft 714 causes cam 718 to rotate. When cam 718 rotates, cam follower 732 of pump assembly 730 also rotates. Cam follower 732 can rest against cam 718 and be pushed in direction V1. As cam follower 732 moves in direction V1, cam follower 732 causes upper member 734 to move toward lower member 736. This can compress bias member 738. In several examples, when bias member 738 is compressed, pump assembly 730 changes from the closed position to the open position. In the open position, pump assembly 730 can dispense prescription substances from housing 132. The biasing member 738 can bias the upper member 734 along direction V2 such that the pump assembly 730 remains in the closed position until the biasing member 738 is compressed. In some embodiments, the biasing member 738 is a spring. In other embodiments, the biasing member 738 can be any other suitable type of component configured to bias the upper member 734 along a particular direction. In several embodiments, when the valve 710 is in the open position and the pump assembly 730 is also in the open position, the prescription substance can be dispensed from the housing 132. In such embodiments, the prescription substance can be dispensed from the housing 132 to the intended user.

The following table lists the reference numerals and their corresponding object names:

Table 1 - Figure labels and corresponding label object names.

Those skilled in the art will recognize that the above-described apparatus, systems, and methods can be modified in various ways. Therefore, those skilled in the art will understand that the embodiments covered by this disclosure are not limited to the specific exemplary embodiments described above. In this regard, while illustrative embodiments have been shown and described, a wide range of modifications, alterations, and substitutions are contemplated in the foregoing disclosure. It should be understood that such changes can be made to the foregoing without departing from the scope of this disclosure. Therefore, it is appropriate that the appended claims be interpreted broadly and in a manner consistent with this disclosure.

Claims (30)

1. A component for safely dispensing a substance to a intended user, the component comprising: The first component is configured to engage with the outer shell containing the substance in a threaded manner; A second component is connected to the first component, and the second component is configured to securely fasten the first component to the housing; A third component, comprising a cavity whose size and shape are designed to selectively receive the second component; and A valve, which is connected to the first component, such that: When the second component is received within the cavity of the third component, the valve is in an open state, which allows for the dispensing of substance from the housing to the intended user in response to the processor determining that unique biometric properties of the intended user have been detected. When the second component is not received within the cavity of the third component, the valve is in a closed state, which prevents the substance from being dispensed from the housing. 2. The component for safely dispensing a substance to an intended user according to claim 1, further comprising: A biasing member is configured to bias the valve to a closed state when the second member is not received within the cavity of the third member. 3. The component for safely dispensing a substance to an intended user according to claim 2, wherein the biasing component is compressed when the second component is received within the cavity of the third component. 4. The component for safely dispensing a substance to an intended user according to claim 1, wherein the first component includes a plurality of latching components configured to surround a lip portion of the housing, the plurality of latching components being configured to prevent the first component from being removed from the housing in an axial direction. 5. The component for safely dispensing a substance to an intended user according to claim 4, wherein the second component includes a distal portion configured to surround the plurality of latching components to prevent the plurality of latching components from being removed radially from the lip of the housing. 6. The component for safely dispensing a substance to an intended user according to claim 5, wherein the plurality of latching components are arranged circumferentially around the periphery of the first component. 7. The component for safely dispensing a substance to an intended user according to claim 1, wherein the first component comprises at least one proximal latching component. 8. The component for safely dispensing a substance to an intended user according to claim 7, wherein the second component includes at least one latch configured to engage with at least one proximal latching member of the first component to prevent the second component from being removed from the first component in an axial direction. 9. The component for safely dispensing a substance to an intended user according to claim 1, wherein the valve includes a longitudinal axis, and wherein the second component is configured to rotate about the longitudinal axis of the valve when the second component is coupled to the first component. 10. The component for safely dispensing a substance to an intended user according to claim 1, wherein the unique bioassay property includes the intended user's unique dentition. 11. The component for safely dispensing a substance to an intended user according to claim 10, further comprising: A mouthpiece having a sensor array, wherein a substance is dispensed from the housing to the mouth of the intended user via the mouthpiece. 12. The component for safely dispensing a substance to a intended user according to claim 11, wherein the processor is configured to determine that a unique biometric attribute of the intended user is detected by the sensor array. 13. The component for safely dispensing a substance to an intended user according to claim 11, wherein the sensor array is a capacitive sensor array. 14. The component for safely dispensing a substance to an intended user as claimed in claim 13, wherein the data obtained by the capacitive sensor array includes a capacitance map associated with the intended user. 15. The component for safely dispensing a substance to a intended user according to claim 14, wherein determining that the sensor array detects the unique biometric attribute of the intended user comprises comparing the capacitance map associated with the intended user with a predetermined capacitance map associated with the intended user. 16. The component for securely dispensing a substance to an intended user according to claim 1, wherein the second component includes one or more sensors located on an upper surface of the second component, the one or more sensors being configured to provide a unique identifier associated with the intended user. 17. The component for safely dispensing a substance to an intended user according to claim 16, wherein the third component includes one or more detectors located on a lower surface of the third component, the one or more detectors being configured to contact the one or more sensors of the second component when the second component is received within the cavity of the third component. 18. The component for safely dispensing a substance to an intended user according to claim 17, wherein the one or more detectors of the third component are configured to communicate with the one or more sensors of the second component to receive a unique identifier associated with the intended user. 19. The component for securely dispensing a substance to a intended user according to claim 18, wherein the processor is further configured to dispense the substance from the housing to the mouth of the intended user in response to determining that the one or more detectors have received a unique identifier associated with the intended user. 20. A system for safely dispensing a substance to an intended user, the system comprising: Device casing; A locking cap, which is attached to the housing of the device, the locking cap comprising: The first component is configured to engage with the outer shell containing the substance in a threaded manner; A second component is connected to the first component, and the second component is configured to securely fasten the first component to the housing; A third component, comprising a cavity whose size and shape are designed to selectively receive the second component; and A valve, which is connected to the first component, such that: When the second component is received within the cavity of the third component, the valve is in an open state, allowing the dispensing of substance from the housing; and When the second component is not received within the cavity of the third component, the valve is in a closed state that prevents the dispensing of substances from the housing; A bite bit, which is connected to the device housing, the bite bit including a recess; and The processor is configured as follows: Determine that the intended user's unique dentition is located within the recess of the mouthpiece; and In response to the determination that the unique row of teeth of the intended user is located within the recess of the mouthpiece, a substance is dispensed from the outer shell to the intended user's mouth. 21. The system of claim 20, wherein the mouthpiece includes a capacitive sensor array configured to obtain data about the rows of teeth located within a recess of the mouthpiece. 22. The system of claim 21, wherein the data obtained by the capacitive sensor array includes a capacitance map associated with the intended user. 23. The system of claim 20, wherein the processor is further configured to: Compare the capacitance graph associated with the user of the mouthpiece with the predetermined capacitance graph associated with the intended user. 24. The system of claim 20, wherein the locking cap further comprises a biasing member configured to bias the valve to the closed state when the second member is not received within the cavity of the third member. 25. The system of claim 20, wherein the first member of the locking cap includes a plurality of latching members configured to surround a lip portion of the device housing, the plurality of latching members being configured to prevent the first member from being removed from the device housing in an axial direction. 26. The system of claim 25, wherein the second member of the locking cap includes a distal portion configured to surround the plurality of latching members to prevent the plurality of latching members from being removed radially from the lip of the device housing. 27. The system of claim 20, wherein the second component of the locking cap includes one or more sensors located on the upper surface of the second component, the one or more sensors being configured to provide a unique identifier associated with the intended user. 28. The system of claim 27, wherein the third component of the locking cap includes one or more detectors positioned on the lower surface of the third component, the one or more detectors being configured to contact the one or more sensors of the second component when the second component is received within the cavity of the third component. 29. The system of claim 28, wherein the one or more detectors of the third component are configured to communicate with the one or more sensors of the second component to receive a unique identifier associated with an intended user. 30. The system of claim 29, wherein the processor is further configured to dispense the substance from the shell to the mouth of the intended user in response to determining that the one or more detectors have received a unique identifier associated with the intended user.