Metered-Dose Inhaler Security System
Security features for an electronic metered-dose smart inhaler, mobile app, and cloud-based software system for use with medical prescriptions and clinical trial regimens. The smart inhaler requires several types of user validation and feedback, and enters a locked-out state when required user feedback is not received or when received user feedback raises a suspicion of fraudulent or improper use. While the smart inhaler system is well suited for aerosol medical marijuana products, it may be used to deliver and conduct clinical trials on any type of product suitable for aerosol administration including other types of medication and non-medical products, such as nicotine, herbal products, pain killers, sleep aids, dietary stimulants, dietary suppressants, etc. The security features are not limited to aerosol inhalers, and may be applied more widely to other types of in-home, patient-administered products.
This application claims priority to commonly owned U.S. patent application Ser. No. 16/270,375 (now U.S. Pat. No. ______), which claims priority to U.S. Provisional Application Ser. No. 62/628,102 filed on Feb. 8, 2018 and 62/644,837 filed on Mar. 19, 2018, all of which are incorporated by reference.
TECHNICAL FIELDThe present invention is directed to security features for an electronic metered-dose inhaler and related systems suitable for monitored and controlled human inhalation of aerosol products without burning or vaporizing the products.
BACKGROUNDPhysicians, clinical trial administrators, and product formulators lack effective security mechanisms for ensuring that patients and clinical trial participants taking self-administered medications and other products adhere to medical prescriptions and clinical trial protocols. They also have very limited product delivery choices for ensuring the delivery of precise amounts of medicine and other products that are self-administered by patients and clinical trial participants. Conventional delivery systems for products under prescription and clinical study, such as medication, nicotine, herbal products, pain killers, sleep aids, dietary stimulants, dietary suppressants, etc., also lack effective security mechanisms to prevent unauthorized product use and confirm that only the authorized user has taken an authorized product in accordance with an authorized protocol. This hampers the ability of physicians, clinical trial administrators, and product formulators to assess patient absorption rates, product efficacy, side effects, and optimize product formulations and dispensing techniques. They also lack effective, secure and authenticated electronic techniques for gathering per-dose data and user feedback related to the benefits and side effects from in-home, self-administrated products. This need applies generally to many types of products under prescription, clinical trial, or experimental testing.
As medical marijuana (“MMJ”) continues to become legalized across the United States and worldwide, physicians prescribing MMJ treatment options for select patients will benefit from understanding the MMJ product options and medicines available by licensed MMJ cultivators and formulators. Conventional technology does not provide an automatically updated database of available MMJ medicines and patient efficacy information that physicians can reference to assist in making informed decisions when selecting MMJ formulations and treatment regimes. Traditionally, doctors refer to the Physician's Desk Reference (“PDR”) for guidance on selecting and prescribing medications. But the current PDR does not even contain a category for MMJ. A need therefore exists for new techniques to provide physician guidance to assist in identifying patient conditions suitable for MMJ treatment and prescribing MMJ products well suited to the specific needs of patients with various conditions.
At the same time, a wide range of MMJ products are continually being developed containing precise strains of cannabis and carefully crafted combinations of cannabinoid extracts formulated and tested to be effective for specific ailments. For example, specific MMJ formulations are in various stages of development, clinical testing, approval and deployment for epilepsy, insomnia, intractable pain, migraine headaches, PTSD, Parkinson's, essential tremor, and other ailments. Typically, each ailment is most responsive to a specific MMJ formulation, and the search for specific MMJ formulations to treat a range of ailments is an ongoing industry focus. While many of these conditions are very serious and in desperate need of effective treatments, the MMJ products under consideration are generally considered relatively benign as compared to many other types of medications under development, such as chemotherapies. Less stringent clinical trial and experimental product testing procedures, such as in-home, patient-administered options, may therefore be considered appropriate for MMJ formulations. But cannabis is a well-known recreational drug and there are no in-home, patient-administered MMJ administration systems currently available that provide adequate safeguards to ensure that only authorized patents take the cannabis medications according to authorized protocols.
Another major challenge within the MMJ industry is that there are no consistent and very precise dispensing and delivery methods for MMJ products that can be recommended with confidence by physicians to their patients. Simply instructing patients to smoke a quantity of cannabis flower produces widely varying results among patients. Smoking cannabis is the most unsafe method for consuming the drug due to the carbonization of plant material during the combustion phase. The majority of states that allow MMJ use therefore do not permit the sale or medicinal use of plant material (leaves/flowers/buds) for smoking. Most states instead require the MMJ processors to use extraction processes that remove the beneficial oils from the plant material to form a liquid concentrate of cannabinoids and terpenes. This oil can then be used to produce alternate forms of MMJ consumption. One common method of prescribing the oil is in the form of a vape pen, similar to an electronic cigarette. The oil is combined with a carrier agent and then package in a cylindrical cartridge that contains an internal heating coil. The cartridge is then attached to a battery powered device which heats the coil to a high temperature to vaporize the mixture, allowing the patient to inhale the oil. Again, the heat required to vaporize the oil destroys many of the beneficial cannabinoids in the oil. Other factors that negatively affect the ability to control dispensing through inhalation include inconsistent inhalation depth and duration by the patient (long or short inhale), how long the inhaled product is held in the lungs by the patient (2 seconds or 20 seconds). The primary advantage to smoking or vaping MMJ is that “time to onset” is relatively quick and the effects of the MMJ is generally felt by the patient in only a few minutes. Ingesting edible MMJ products typically has a much longer time to onset, up to an hour, as well as a longer duration of the effect.
Other types of MMJ products include packaging the extracted oils in gel tablets, tinctures in glass bottles with eye droppers or in the form of edible products. The quantity of MMJ product ingested by the patient is virtually impossible to verify, as is the amount of the prescribed product that makes it through the patient's digestive system and into the bloodstream. Stomach acids destroy and the liver filters out many of the beneficial cannabinoids in the medicine. For example, when a patient ingests a 10 mg gel tab, after traveling through the digestive tract, only 15% to 30% of the medicine is typically absorbed into the bloodstream. MMJ ingestion again poses challenges for physicians in controlling accuracy and consistency in the delivery of the medicine. Bioavailability is also heavily impacted when smoking or vaping MMJ because the amount of cannabinoids that are destroyed or damaged by combustion or extreme heating is significant. A need therefore exists for new MMJ product delivery techniques that do not rely on burning or vaporizing the MMJ product at the time of consumption.
SUMMARYThe present invention meets the needs described above through security features for an electronically controlled metered-dose inhaler (“smart inhaler”) and related systems and methods for delivering, controlling and monitoring aerosol products, such as MMJ medications. The smart inhaler requires several types of user validation and feedback, and enters a locked-out state when required user feedback is not received or when received user feedback raises a suspicion of fraudulent or improper use. While the smart inhaler system is well suited for delivering MMJ products, it may be used to deliver any type of product suitable for aerosol administration including other types of medication and non-medical products, such as nicotine, herbal products, pain killers, sleep aids, dietary stimulants, dietary suppressants, and so forth. The smart inhaler system provides a robust, network-based system for in-home, patient-administered medications and other products for monitoring disease (or other condition) progression, conducting clinical trials, developing new drugs, evaluating experimental drugs, and so forth. Many of system innovations described in this disclosure are not limited to aerosol inhalers and may be applicable to other types of electronically-controlled, network-connected “smart delivery” devices, such smart nebulizers (e.g., vape pens), potable liquid dispensers, intravenous units, and other in-home, patient-administered delivery devices.
It will be understood that specific embodiments may include a variety of features in different combinations, as desired by different users. The specific techniques and structures for implementing particular embodiments of the invention and accomplishing the associated advantages will become apparent from the following detailed description of the embodiments and the appended drawings and claims.
The numerous advantages of the smart inhaler may be better understood with reference to the accompanying figures in which:
Embodiments of the smart inhaler system include an electronically controlled metered-dose inhaler device (referred to as the “inhaler,” “smart inhaler,” “MDI” or “SMDI”) and related systems and methods that securely controls, monitors, and gathers user feedback and auxiliary device data, such as blood pressure, heart rate, and blood glucose data, related to inhaler usage. The system provides the gathered data for review and analysis by monitors, such as formulators of medications (and other inhalant products), prescribing physicians, clinical trial administrators, artificial intelligence, researchers, developers, facility operators, parents, guardians, authorities, and other authorized parties. The smart inhaler is specifically designed to administer aerosol products without the need to burn, vaporize, combine or otherwise prepare the products, other than by shaking the inhaler, at the time of inhaler use. The smart inhaler also ensures proper shaking prior to unlocking the inhaler for a dosing event.
The smart inhaler is suitable for administering MMJ protocols but is not limited to MMJ or other prescribed medications. The smart inhaler can be used to administer any type of inhaler protocol, such as medical prescriptions, clinical trials, and other protocols related to rehabilitation, addiction withdrawal, exercise, diet, safety testing, efficacy testing, judicial supervision, and so forth. The specific examples described in this disclosure are well suited to administering a wide variety of aerosol products in a range of protocols specifying dosing event quantities and time schedules. For example, the smart inhaler system could be used to administer nicotine, herbal products, anesthesia, and other non-medication type products. The smart inhaler system also allows medical prescriptions and other protocols to be changed remotely, typically in response to user feedback received in the course for the protocols. While the innovations have wider applicability, the illustrative embodiments are specifically designed for administering aerosol cannabis medications without the need to heat or vaporize the medication as part of inhalant administration.
The smart inhaler system presents tremendous opportunities for secure, per-dose monitoring of in-home, patient-administered medications and other products for monitoring disease (or other condition) progression, conducting clinical trials, developing new drugs, evaluating experimental drugs, and so forth. Many of the system-based and cloud-based innovations described in this disclosure are not limited to an inhaler and the product administering device and, as such, may be applicable to electronically controlled nebulizers (vape devices), potable liquid dispensers, intravenous units, and other types of product delivery devices.
The representative embodiment includes multiple security features, including features implemented by an electronically-controlled smart inhaler that reads electronically-readable canister information carried on the cartridge (i.e., on the canister or on the mouthpiece carrying the canister), features implemented by an a mobile app running on a user's mobile communication device (e.g., smartphone), and features implemented by a number of network resources referred to collectively as the “cloud.” The cloud may include a wide range of databases and systems. The examples illustrated by the specific embodiments include systems operated by the formulator (e.g., manufacturer of the canister contents), the provider (e.g., prescribing physician or clinical trial administrator), dispensaries (including mail order dispensaries) that issue pump units and cartridges to users, and artificial intelligence platforms that analyze smart inhaler and related data from multiple users to identify medically significant factors and trends for use in efficacy analysis and the development of new protocols and formulations.
The smart inhaler system also integrates a range of auxiliary monitoring devices used to collect diagnostic data from a user in the course of a protocol. Representative auxiliary devices include a blood oxygen monitor, heart rate activity monitor, respiration monitor, blood pressure monitor, body temperature thermometer, blood glucose monitor, and so forth. The mobile app gathers and correlates the smart inhaler data with the measurement data from the auxiliary devices, for example by synchronizing, scaling and organizing the data for combined display on a common chart or time scale. The smart inhaler data set may be augmented with other diagnostic data obtained separately, such as MRI, CAT, X-ray, EKG, EEG, genome sequencing, medical history, family medical history, etc. Additional analysis conducted by the mobile app or cloud systems help to reveal the effect of the products delivered through inhaler operation on the user, which is typically reflected by the measurement data obtained by the auxiliary monitoring devices.
The smart inhaler system includes a number of safeguards to ensure that the inhaler is only used by the authorized user in an authorized manner. This makes the smart inhaler system suitable for use in many applications where security is an important factor. For example, a smart inhaler may be used to ensure that a controlled substance or prescription medication is only administered to the proper patient in accordance with a proper prescription. This address the several problems with conventional medication delivery systems, such as another person surreptitiously taking the patient's medication, the patient selling or giving the medication to someone else, the patient not taking the medication in accordance with the prescription, use of expired prescriptions, effectively administering product recalls, and effectively administering clinical trials. The inhaler pump unit may be issued separately (e.g., when a prescription, clinical trial or other protocol is initiated), while the cartridges will typically be issued separately and more frequently (e.g., each time a protocol cartridge is refilled). The inhaler pump unit is therefore designed to be used for many canisters, while each mouthpiece units is designed to be used with a single canister as a one-time use disposable cartridge. If desired, the same inhaler can be configured, for example through the use of passwords, MMJ Registration Card numbers, and bio-identifiers together with reading of cartridge (canister) information and prescription verification, to handle multiple prescriptions for individual or multiple persons. Bluetooth® pairing, along with cartridge and prescription verification, allows the same inhaler pump unit to be configured to communicate with multiple apps running on different mobile devices registered to different users. For example, a single pump unit could be used to administer products to multiple patients or clinical trial subjects who travel to the same location for inhaler use.
The smart inhaler system includes several different types of safeguards. Particular embodiments may include one or more of these safeguard features, and each inhaler need not include all or any particular combination of these features. A specific smart inhaler is typically registered to work only with a specific mobile device, as controlled by a mobile app running on the mobile device. A user's smart inhaler pairs with the user's mobile communication device, typically through a Bluetooth link, to verify that the inhaler is registered to the user, and that the canister corresponds to a valid prescription written for the user. Although the user's smart inhaler may operate according to a verified prescription without connecting to the user's mobile device at the time of product administration, it must be connected at some point prior to initial product administration to confirm that the canister in the user's inhaler corresponds to the user's prescription. The mobile app keeps track of the number of doses taken and the number remaining in the canister. The inhaler and the mobile app provide a variety of notifications indicating that a dosing window is open, the canister is nearing empty, the canister is empty, and when the canister is placed into a locked-out state for a number of different reasons. For example, the inhaler may be locked-out for use with a particular cartridge because it is not loaded with a verified cartridge, the cartridge has been recalled or expired, there are no more doses remaining in the canister, or when unauthorized use has been detected or been attempted. In a particular embodiment intended for a child or elderly person's inhaler, voice notifications may be played in a voice familiar to the user. Notifications or alarms may also be sent by voice message, text message, email or other techniques to a communication device associated with an authorized third party, such as a parent, guardian, physician or care taker. In another embodiment intended for clinical testing, notifications or alarms may be automatically sent to the administrator of the clinical trial.
In addition, there three types of physical locks available, a single-use clasp in the mouthpiece, a dispensing button lock, and an engagement lock. The single-use clasp allows a canister to be inserted into the mouthpiece unit one time, and then breaks away to disable the mouthpiece if the canister is removed from the mouthpiece. This effectively configures the mouthpiece as a disposable unit restricted to working with a single canister. The dispensing button lock includes a movable abutment controlled by the microprocessor in the pump unit that only allows the dispensing button to be depressed to dispense product from the canister in accordance with a valid and verified protocol. The engagement lock includes an abutment in the mouthpiece that prevents product from being dispensed from the canister when the mouthpiece is not installed in the pump unit. This prevents unauthorized persons from circumventing the dispensing button lock by manually depressing the canister into the mouthpiece when the mouthpiece is not installed in the pump unit.
The cartridge, consisting of a canister installed in a mouthpiece unit, carries an electronically readable label or chip with information about the product in the canister, such as a medication description. The pump unit will not work with a cartridge until the cartridge has been validated with a prescription (or other protocol) for use by the user. Cartridge verification requires the pump unit to read canister information stored by a cartridge memory carried by the cartridge. The pump unit must also become paired with and interact with the mobile app running on a mobile device that is registered for use with that specific pump unit (or canister in a multi-user embodiment). This requires matching the cartridge with a valid prescription (or other protocol) written for the authorized user of the inhaler. While the pump unit reads the cartridge information from the cartridge memory, the user's prescription (or other protocol) is typically obtained from another location, such as the cloud via the mobile app running on the user's mobile device.
An authorized user may also be required to enter pre-dose identification information, such as a password, MMJ Registration Card number, or bio-identifier (e.g., fingerprint, retina scan, etc.), to activate the inhaler. The user may also be required to enter post-dose feedback through the mobile app, which may include providing a written account, picture, photo, chat or other multi-media or interactive feedback. The post-dose feedback may be required immediately after taking a dose and at one or more other times following a dose. The post-dose feedback may be used to detect suspected fraudulent or improper use of the inhaler, which causes the inhaler to enter a locked-out state until the suspected fraud or improper use has been resolved. Feedback received from the mobile app can be used for a number of other purposes including dose confirmation, prescription modification, and analyses of medication efficacy, side effects, time to onset, and so forth. Feedback from multiple users may be used to create a multi-user, multi-product database for further analysis including analysis by artificial intelligence and other researchers.
Illustrative embodiments of the smart inhaler and related systems and methods are described below with reference to the appended figures.
A central feature of the system 10 is an electronically-controlled, hand-held, smart metered-dose inhaler 11, which includes a pump unit 11a and a removable cartridge 11b that includes a mouthpiece unit carrying a canister (see
The mobile app 12 communicates over a suitable network (e.g., mobile telephone, private data network, Internet, intranet, ethernet, etc.) with the provider system 15a, which issues a prescription 15b for the user, which the user typically picks up or receives in the mail from a dispensary 15c. For example, the prescription 15b may be issued in the form a cartridge 11b including an aerosol medication canister held within a mouthpiece unit that is inserted into the pump unit 11a of the smart inhaler 11. This allows the same pump unit 11b to be used with many different cartridges including refill cartridges. The provider system 15a may obtain additional clinical tests 14 related to the user, such as blood tests, lab tests, and so forth. The provider system 15a also interacts with other elements of the system 10. For example, the provider system 15a typically orders medication cartridges with specific formulations from the formulator 18, which delivers prescribed cartridges to the dispensary 15c for delivery to the patient.
Ultimately, many smart inhalers, physicians, clinical trial administrators, formulators, Al platforms, researchers, and developers will be interconnected by the cloud 17 allowing a large body of clinical data to the gathered regarding inhaler use, user feedback, auxiliary device data, clinical tests, and other relevant data for use in prescribing medications and conducting research and development. This will include analyses conducted by artificial intelligence as wells as human R&D teams at universities, foundations, corporations, and so forth. The system 10 thus represents an important advancement in the field of MMJ because this type of data is currently lacking, while a wide range of MMJ products are currently being developed to treat a wide range of conditions. The system 10 also represents an important and more general advancement in security, monitoring and administration of prescriptions, disease (and other condition) progression, clinical trials, and experimental drug testing through distributed used of in-home, patient-administrated delivery devices.
To further advance the research and development process, the cloud 17 connects the elements of the system 10 with an artificial intelligence (“AI”) system 19, which includes one or more platform and related software, which may include multiple Al platforms at various research universities, foundations and companies. Generally described, the Al system 19 receives patient medical data from the various systems interconnected by the cloud 17, applies predictive modeling, and provides enhanced data and predictive modeling results back to other cloud elements. This information can then be used to develop new MMJ formulations and protocols. The patient medical data supplied to the Al system 19 typically includes, but is not be limited to, device status, medication usage, dispensing habits, formulation efficacy, and patient feedback gathered on various devices and network servers. The Al system software automatically sorts, parses and analyzes all data and places it into unique categories. These categories may be created based on a variety of inputs, such as but not limited to, current medical diagnosis, physiological characteristics (age, weight, sex, race, health status, etc.), family medical history (mother, father, grandparents, etc.), DNA analysis (ancestry, genealogy, genetic predisposition to diseases/medical conditions), etc. The Al software analyzes all of these factors along with any other available data that could possibly impact the outcomes of treatment for each individual and then incorporate predictive modeling for improving efficacy of medications and treatment plans based on combinations of the patient inputs.
For example, when the Al software has processed and analyzed the available characteristics data from 200 individual patients suffering from multiple sclerosis (MS) in combination with their prescribed treatment plans, treatment adherence, prescribed medicine formulation(s), efficacy results and personal feedback and other input, the Al can then begin to model this data to predict how individuals will likely react to specific treatment plans for MS. Expanding on this example, when the Al has identified a treatment plan (e.g., specific formulation(s), dosing amounts, dosing frequency, duration of treatment, etc.) with a target success rate (e.g., 72%) for a specific group of patients suffering with MS and with very similar characteristics, the Al can generate an optimized medical cannabis treatment plan for physicians to administer and prescribe to new MS patients. This guidance in prescribing a treatment plan, with a high success rate, will eliminate relying on physicians to effectively guess at what may or may not be effective for an MS patient. With regards to the portion of MS patients that did not benefit from treatment plan under evaluation (i.e., the other the 28% in the example with a 72% success rate), the Al can make predictions and suggest to the formulator how a specific formulation can be adjusted and optimized for higher efficacy for these remaining patients. The Al may also provide suggestions to a physician on what aspects of a potential treatment plan may provide more benefits to these patients. As more efficacy data for MS patients is collected and analyzed, the Al predictive modeling for effective formulations and successful treatments plans for individual patients will become more accurate.
The cartridge 11b includes a canister 25 that is permanently attached to a mouthpiece unit 26 by a single-use clasp 27. The single-use clasp 27 engages the canister 25 when the canister is initially installed into the mouthpiece unit 26 to prevent the canister from being removed from the mouthpiece unit without breaking the clasp, which disables the mouthpiece from operably receiving another canister. The single-use clasp 27 is a safety measure that effectively turns the mouth-piece into a disposable single-canister device. The cartridge 11b also includes a cartridge memory 28, such as a barcode, QR code, RFID tag, or NFC chip, that contains canister information including a description of the product contained in the canister 25. The single-use clasp 27 restricts the mouthpiece unit 26 to working with a single canister 25, which allows the cartridge memory 28 to be carried by the canister 25 or the mouthpiece unit 26, as desired. Thus, the cartridge memory 28 is typically encoded when the canister 25 is installed into the mouthpiece unit 26. The pump unit 11a includes a cartridge reader 29 powered by the onboard battery 24 that reads the cartridge memory 28 when the cartridge 11b is installed in the pump unit. The medication description may be directly stored by the cartridge memory 28, or the cartridge memory may store a code that the microprocessor 11c uses to look up (index) an associated medication description stored in the memory 11d (i.e., the memory may store an onboard medication index updated from the cloud 17 from time to time). Alternatively or additionally, the mobile app 12 may use the code to look up (index) an associated medication description stored in the cloud 17, for example in an online medication database associated with the formulator 18 or the provider 15a.
In particular embodiments, for example, the cartridge memory 28 may be a barcode, RFID tag, or NFC chip and the cartridge reader 29 may be an optical barcode reader, RFID reader, or NFC reader. In the barcode and RFID embodiments, the cartridge reader 29 is typically turned on momentary upon a cartridge being installed to allow the pump unit to read the cartridge memory 28. In an NFC embodiment, the NFC antenna in the cartridge is typically turned on momentary upon a cartridge being installed to allow the NFC reader in the pump unit to read the NFC tag. Upon successfully reading the tag data, the NFC antenna automatically turns off to conserve battery power until a new cartridge installation event.
The user pairs the microprocessor inside the pump unit 11a with the mobile device running the mobile app 12 (e.g., via Bluetooth link) to activate and control the smart inhaler 11. As a security measure, the mobile app 12 checks the registration information of the mobile device against the registration information of the smart inhaler 11 (or the specific canister 25 in a multi-user embodiment) to ensure that the inhaler is going to be used by an authorized user. The medication within the canister 25 is identified by the canister information stored by the cartridge memory 28. When the cartridge 11b is inserted into the pump unit 11a, the cartridge memory reader 29 in the pump unit reads the canister information from the cartridge memory 28, which is uploaded to the mobile app 12. The mobile app 12 also downloads the user's prescription from the provider system 15a. As another safeguard, the pump unit 11a keeps the pump actuator 23 locked (e.g., an abutment blocks the dispensing button) unless the mobile app 12 verifies that the product in the canister 25 corresponds to a valid prescription issued to the user verified through the provider system 15a. Upon verification of the user registered to the inhaler 11, a valid prescription issued to the same user, and determination that a dosing window is open in accordance with the prescription, the pump unit 11a unlocks the pump actuator 23 for a dosing event, for example by moving an abutment to unblock the pump actuator.
The pump unit 11a also includes an LED indicator 34 powered by the onboard battery 24 that indicates the status of the pump unit. For example, the LED indicator 34 may be off when the smart inhaler 11 is locked between dosing events, may illuminate or flash green to indicate that the inhaler is unlocked and ready for a dosing event, and may illuminate or flash red when the smart inhaler is in a locked-out state. For example, the LED may illuminate or flash red to when the inhaler is locked-out due to a pairing failure caused by a mismatch between the inhaler (or canister) credentials and the user's credentials stored by the user's mobile unit. The inhaler may also lock-out due to a mismatch between the medication in the canister, as reflected by the canister memory, and the user's prescription or recall or expiration of the product in the canister. As additional examples, the inhaler may lock-out because the user has not entered required feedback for a prior dose, because fraudulent use or attempted misuse of the inhaler has been detected, due to a canister recall or expiration, or a change in prescription removing the user's authorization to take the medication in the canister. The LED may flash in different patterns to signify these different lock-out reasons. The LED indicator may also be augmented by audible alarms, a voice notification, or a vibration to indicate the inhaler status. The pump unit status may be accompanied by notifications displayed or played by the user's mobile device under the control of the mobile app 12. Voice notification by the pump unit or the mobile app may be particularly useful for children, elderly, and ill users who may be more likely to understand or comply with voice notifications in a familiar voice, such as notifications recorded in the voice of a parent, guardian, other family member, care taker, or physician.
As another example,
Step 54 is followed by step 55, in which the pump unit determines that a dosing window is open in accordance with the verified dosing protocol. This typically includes unblocking the pump actuator for a designated number of puffs (e.g., pushes of the dispensing button) and activating notifications on the pump unit and the user's mobile device. The user's pump unit stores its own copy of the dosing protocol so that the pump unit can administer the protocol even when connectivity is not available between the pump and the mobile app. Step 55 is followed by step 56, in which the mobile app receives and validates user identification information, such as a password, MMJ Registration Card number, fingerprint, retina scan, photo, face scan, voice command, or other user identification. Step 56 is followed by step 57, in which the smart unit mobile app causes the pump unit to unlock for the dosing event, for example by removing an abutment that prevents the dispensing button from being depressed. Step 57 is followed by step 58, in which the pump unit determines that the dose has been administered or the dosing window has expired.
If connectivity exists between the pump unit and the smart inhaler mobile app, the pump unit uploads this information to the smart mobile unit in real-time time. Otherwise the pump unit uploads the information when connectivity is reestablished. Similarly, if connectivity exists between the smart inhaler mobile app and the cloud, the mobile app uploads this information in real-time to the cloud (e.g., with the online system operated by the user's physician or clinical trial administrator). Otherwise the mobile app uploads the information when connectivity is reestablished. Step 58 is followed by step 59, in which the pump unit locks the inhaler, for example by moving the abutment to prevent the dispensing button from being depressed. Following step 59, the routine 50 returns to step 55, in which the pump unit and mobile app wait for another dosing event. When another cartridge engagement is detected, routine 50 goes back to step 51 (cartridge engagement detected) and continues from there.
Step 71 is followed by step 72, in which the smart inhaler is locked-out for the selected dosing protocol, for example by blocking or disabling the dispensing button on the pump unit. In multi-protocol and multi-user embodiments, the smart inhaler can be locked-out on a per-cartridge and on a per-user basis. Step 72 is followed by step 73, in which the mobile app notifies cloud components, as appropriate, of the lock-out status. For example, the prescribing physician or clinical trial administrator may be notified of lock-outs ordered by a product formulator, and the product formulator may be notified of the successful lock-out for each specific canister subject to a product recall or expiration. Step 73 is followed by step 74, in which the pump unit activates an internal alarm protocol, and step 74 is followed by step 75 in which the mobile app activates an external alarm protocol, to notify the user of the lock-out status.
Step 82 is followed by step 83, in which the smart inhaler determines whether the inhaler has been properly shaken. More specifically, the onboard accelerometer provides an acceleration signal to the microprocessor, which may awake from a sleep status and read a shake protocol from the on board memory. The shake protocol may be part of the cartridge information read from the memory, which is specific to the product in the canister. The shake protocol may also be downloaded from the cloud systems associates with the formulator the provider. As a result, the smart inhaler does not active for a dosing event until the inhaler has been properly shaken, which may be indicated by a change in the illumination or flashing state of the LED indicator or other suitable notification (e.g., beeping or voice notification “canister is adequately shaken”). Step 83 is followed by step 84, in which the smart inhaler is unlocked for the dosing event, which may be accompanied by its own internal and external notifications.
In general, pre-dose and post-dose verification and feedback requirements may be established on a per-cartridge basis. Although the verification procedures may be applied by the mobile app or the smart inhaler, or a combination, mobile app verification for an illustrative subject protocol is described below. Step 91 is followed by step 92, in which the mobile app determines whether the pre-dose authorization information is properly validated. If the pre-dose authorization information is not validated, the “no” branch is followed from step 92 to step 98, in which the smart inhaler is placed into a locked-out state for the subject protocol. If the pre-dose authorization information is validated, the “yes” branch is followed from step 92 to step 93, in which the inhaler is unlocked for the dosing event. After the dose has been administered, step 93 is followed by step 94, in which the mobile app should receive post-dose feedback. While required post-dose feedback is typically maintained by the mobile app 12 in accordance with settings information, the provider 15a or the formulator 18 may also establish post-dose feedback requirements or request specific post-dose feedback on a case-by-case basis. This typically involves a post-dose notification send from the provider 15a or the formulator 18 to the mobile app 12. User verification is typically required before the user can enter the post-dose feedback. In addition, multiple types of post-dose feedback may be required at one or more different times, such as dose confirmation immediately following the dosing event and feedback about how the user is feeling at a later time. For example, the user may be required to enter post-dose feedback in the morning to explain how well the user slept, how well the dose worked, how much pain the user experienced, other discomfort, and side effects the user may have experienced. The smart inhaler may remain locked until the correct type of post-dose feedback has been received. The post-dose feedback can therefore be used to monitor product efficacy, patient condition, and side effects on a per-dose basis, which can be very valuable for dose modification, monitoring disease (or other condition) progression, and clinical trial administration. Missing post-dose feedback may be used to detect fraudulent or other improper use of the inhaler. Post-dose feedback received, such as textual or photo feedback, can also be analyzed by the mobile app or cloud-based systems to detect fraudulent or other improper use of the inhaler. The smart inhaler system thus provides innovative opportunities for secure, per-dose monitoring of in-home, patient-administered medications (or other products) for monitoring disease (or other condition) progression, conducting clinical trials, developing new drugs, evaluating experimental drugs, and so forth.
Step 94 is followed by step 95, in which the mobile app determines whether the required post-dose feedback has been received. If the required post-dose feedback not has been received, the “no” branch is followed from step 95 to step 98, in which the smart inhaler is placed into a locked-out state for the subject protocol. If the required post-dose feedback has been received, the “yes” branch is followed from step 95 to step 96, in which the mobile app analyzes the post-dose feedback for fraud detection. This may include downloading information from one or more cloud platforms or uploading the post-dose feedback to one or more cloud platforms that conduct or participate in the analysis. Step 96 is followed by step 97, in which the mobile app determines whether fraudulent or other improper use of the smart inhaler has been detected. If fraudulent or other improper use of the smart inhaler has not been detected, the inhaler remains in a not-locked-out state for the selected protocol and the “no” branch is followed from step 97 back to step 91, in which the inhaler waits for another dosing event. If fraudulent or other improper use of the smart inhaler has been detected, the “yes” branch is followed from step 97 to step 98, in which the smart inhaler is placed into a locked-out state for the subject protocol. Step 97 is followed by step 98, in which the smart inhaler initiates an applicable internal alarm protocol and the mobile app initiates an applicable external alarm protocol for the locked-out condition.
Information 108 is downloaded from the cloud 102 by the app 104 via WIFI and/or mobile network connectivity. In this particular example, the information 108 includes a prescription 110, a dosage schedule 112, a questionnaires 114, firmware updates 116, dispensary details 118, recalls 120 and physician appointment and booking details 122. The information 108 may be updated on the cloud 102 and downloaded in real-time to the app 104 so long as WIFI and/or mobile network connectivity between the app 104 and the cloud 102 is maintained.
In addition, information 124 is typically downloaded from the app 104 to the inhaler 106 via a Bluetooth link. The information 124 includes a prescription 110 and a dosage schedule 112, which may be updated on the app 104 and downloaded in real-time to the inhaler 106 so long as Bluetooth connectivity is maintained between the app 104 and the inhaler 106. If Bluetooth connectivity is lost between the inhaler 106 and the app 104, the information 124 is stored on the inhaler until it is updated via download from the app 104 when Bluetooth connectivity is reestablished. This allows the inhaler 106 to continue to operate according to the dosage schedule 112 while connectivity is lost, and then push notifications to the app 104 when connectivity is reestablished between the inhaler 106 and app 104.
Step 202 is followed by step 206, in which the app 104 causes the user's mobile device to scan for Bluetooth devices in the vicinity of the mobile device. If the inhaler is within range of the mobile device, step 206 is followed by step 208, in which the mobile device compares the user's credentials stored by the app 104 against the credentials stored on the inhaler 106 to ensure that the mobile device is paired to the correct inhaler. This is a security measure requiring the particular inhaler to be registered to a particular mobile app installed on a particular mobile device, with this step ensuring that only the specific inhaler registered to operate with the specific mobile device can be paired the particular inhaler. For example, the user's inhaler 106 is registered to pair only the user's mobile device, as controlled by the mobile app 104 installed on the user's mobile device, when the inhaler is initially issued (and possibly prescribed by a physician) for use by that particular user. This may include receiving a passcode or bio-identifier (e.g., fingerprint, retina scan, face photo, face scan, voice command) associated with the user. Step 208 is followed by step 210, in which mobile device app 104 determines whether the user's inhaler 106 is successfully paired with the user's mobile device running the mobile device app 104. If the inhaler is not successfully paired with the mobile device, the “no” branch is followed back from step 210 to step 206, in which the mobile device continues to scan for Bluetooth devices in the vicinity of the mobile device. If the inhaler is successfully paired with the mobile device, the “yes” branch is followed from step 210 to step 212, in which information (such as information 124 in
Step 214 is followed by step 216, in which the app 104 routinely checks whether the user's inhaler 106 is still paired to the user's mobile device. If the inhaler is no longer paired with the mobile device, the “no” branch is followed back from step 216 to step 206, in which the mobile device scans for Bluetooth devices in the vicinity of the mobile device. If the inhaler remains paired with the mobile device, step 216 is followed by step 218, in which the app 104 checks the cloud 102 for updates to be downloaded (for example, updates to the information 108 shown in
Referring again to
In this particular embodiment, the inhaler 106 compares the prescription 110 (downloaded from the cloud, for example from the prescribing physician's website) to the medication description 128 carried on the canister or mouthpiece, which may be issued separately from the inhaler pump unit (for example by a dispensary) to determine if there is a match. If the prescription 110 matches the medication 128 in the canister, the lock 138 is disengaged allowing the inhaler to dispense according to the dosage schedule 112. If the prescription 110 does not match the medication 128, the lock 138 is engaged to prevent the inhaler 106 from dispensing.
Following the delivery of a dose, the inhaler updates the canister information 126 including the doses delivered 132 and doses remaining 134. The updated canister information 126 is uploaded from the inhaler 106 to the app 104 via Bluetooth connectivity. The upload from the inhaler 106 to the app 104 occurs in real-time if Bluetooth connectivity is available between the user's inhaler and the user's mobile device. Alternatively, if Bluetooth connectivity is not available at the time of dose administration, the canister information 126 is uploaded at a later time when Bluetooth connectivity reestablished. This allows the inhaler 106 to push notifications to the app 104, such as doses remaining 134, when connectivity between is reestablished between the inhaler 106 and app 104. The app 104 then uploads information 140 (including the updated canister information 126 received from the inhaler 106) to the cloud 102 via WIFI and/or mobile network connectivity. This information 140 may also include answers to questionnaires 142 (such as post-dosage feedback), purchases 144, and ancillary device information 146. Again, the app 104 uploads the updates to the cloud 102 in real-time if communication connectivity is available between the user's mobile device and the cloud. Alternatively, if connectivity is not available when the app receives an update from the inhaler, the canister information 126 is uploaded at a later time when communication connectivity reestablished. It should be noted that additional post-dose feedback may be received from the user and uploaded to the cloud at one or more specified times after dose administration, such one hour later, at the time of expected medication onset, at bed time or in the morning. This additional reporting provides a safety mechanism for fraud detection as well as a richer information set for assessing the effectiveness and side effects of the product administered by the inhaler on a per-dose basis. This higher level of user feedback may be particularly advantageous when the inhaler is used for controlled substances, clinical trials, addiction treatment, judicial supervision, cases of prior inhaler misuse, acute care, higher-risk settings (e.g., foster care, hospice) and other situations that justify heightened reporting requirements.
If the prescription matches the medication contents, the “yes” branch is followed from step 304 to step 306, in which the app checks for a product recall, prescription change, authorization change or other factor indicating that inhaler should not be used to administer the product in the canister. This may include checking or downloading information from multiple cloud locations, such as websites associated with the formulator, provider, clinical trial monitor, guardian, facility (e.g., hospice) manager, caseworker, parole officer, judicial supervisor, offender database, and so forth. If there is a product recall or other information indicating that the contents of the canister should not be administered, the “yes” branch is followed from step 306 to step 310, in which the app places the inhaler in a locked-out state for the applicable cartridge, typically by blocking the dispensing button. If there is no product recall or other information indicating that the contents of the canister should not be administered, the “no” branch is followed from step 306 to step 308, in which the mobile app determines whether the authorized doses (or dosage) have been reached or exceeded, typically by checking the prescription against the updated canister information reflecting prior dose administration from the canister. If the authorized doses (or dosage) have been reached, the “yes” branch is followed from step 306 to step 310, in which the app places the inhaler in a locked-out condition for the applicable cartridge, typically by blocking the dispensing button. If the authorized doses (or dosage) have not been reached, the “no” branch is followed from step 308 to step 314, in which the inhaler and the mobile app activate notifications to alert the user that a dosing window is open (dose scheduled). The inhaler then allows the dispensing button on the inhaler to be depressed only enough times (and may also restrict the depth of depression of the button) to allow the user to take the scheduled quantity.
Following administration of the scheduled dose, step 314 is followed by step 316, in which the inhaler updates the canister information to reflect this dose, which is uploaded to the app. The upload occurs in real-time if there is connectivity between the inhaler and the app. Alternatively, if there is no connectivity at the time of dose administration, the upload occurs when connectivity is reestablished. Similarly, the app may upload information reflecting dose administration to the cloud, where it is received and reviewed by authorized personnel or systems. In this particular embodiment, step 316 may be followed by step 318, in which the inhaler scans for Bluetooth devices. If a mobile device is located within pairing range, step 318 is followed by step 320, in which the inhaler pairs with the mobile device and checks the credentials of the inhaler against the credentials to ensure that the user's inhaler only pairs with user's mobile device, which it is registered to work with. This may include receiving a passcode or bio-identifier (e.g., fingerprint, retina scan) associated with the user and other security checks. If the credentials and other security checks are confirmed, step 320 is followed by step 322, in which the inhaler determines whether it is paired with the user's mobile device. If the inhaler is not paired with the user's mobile device, the “no” branch is followed back to step 318, in which the inhaler scans for Bluetooth devices, which may include attempting to pair with another mobile device within pairing range. If the inhaler is not paired with the user's mobile device, the “yes” branch is followed to step 324, in which the inhaler canister information update is uploaded from the inhaler to the mobile app. The inhaler canister information update may also be uploaded from the mobile app to the cloud. Step 324 is followed by step 326, in which the user's mobile device (as controlled by the mobile app) and the inhaler activate notifications indicating that the scheduled dose has been taken and recorded.
To activate the smart inhaler 11, step 405 is followed by step 406, in which the patient pairs the microprocessor 11c in the pump unit 11a with the smart inhaler mobile app 12 running on the user's mobile device, typically a smartphone. (See
After the user takes the authorized dose, the inhaler 11 automatically locks and step 410 is followed by step 411, in which the inhaler 11 uploads a dose confirmation to the patient's mobile app 12, which uploads the dose confirmation to the provider's mobile app 16, which may further upload the dose confirmation to the formulator 18. Step 411 is followed by step 412, in which the formulator 18 or the provider 15a, typically through the mobile app 16, may send a post-dose notification to the patient's mobile app 12. Step 412 is followed by step 413, in which the user enters identification information, which is validated by the mobile app 12 (see
The smart inhaler system 10 can also be used to order and fill new prescriptions and refill prescription. This is represented by step 416, in which the provider mobile app 16 sends a new prescription or refill notification to the patient's mobile app 12. Step 416 is followed by step 417, in which the patient accepts the prescription, which is communicated through a refill acceptance notice sent from the patient's mobile app 12 to the provider's mobile app 16. This may be accompanied by a “stop-use order” for the previous cartridge 11b if there are doses remaining that should not be taken by the patient (see
It will therefore be appreciated that the illustrative embodiments shown in the figures include an electronic metered-dose smart inhaler, mobile app, and cloud-based software system that validates users and inhaler use protocols (e.g., medical prescriptions, clinical trial regimens, experimental drug regimens), controls and monitors per-dose usage, captures efficacy results and feedback from medical cannabis (marijuana) patients for review and input by prescribing physicians, medicine formulators and artificial intelligence. Conventional cannabis delivery methods fail to provide the ability for patient, physician and formulator interaction using per-dose administration and feedback data. This communication loop is critical to ensure that physician recommendations and specific prescribed formulations are beneficial to the treatment of the patients ailment. Medicine effectiveness data and patient symptom feedback is severely delayed to the physician and to the formulator. Patient feedback needs to occur in real-time so that a treatment regime can be adjusted to meet patient needs as quickly as possible between doctor's office visits which typically take place every 90 days.
Protocol administrators, such as physicians and clinical trial operators, using conventional cannabis medicine administration and monitoring systems are unable to make critical early adjustments to patient's regimen due to the time lag in understanding the initial and early effects on the patient. Conventional cannabis systems also fail to provide physicians with a reference database to assist decisions they make on recommending the most effective medicine produced by the best formulator to their patients. Formulators can also benefit from understanding how their medicines are affecting patient ailments and whether formulation adjustments need to be made to specific medicines to increase the efficacy for targeted ailments. Currently there are no existing device systems that allow formulators to gather useful data from patients that help guide in adjusting their medicines to increase the benefits of their medicine product offering.
The smart inhaler system provides systems and methods for collecting and organizing per-dose, typically real-time user feedback that is accessible to physicians, formulators, artificial intelligence, and other research and analysis systems and practitioners The smart inhaler and associated mobile app gather patient (and other user) inhaler use data and allows for user input regarding effectiveness of a protocol administered by the smart inhaler, such as a treatment regime for clinical trial or prescribed medication. This information is gathered and stored on a centralized network server where physicians, formulators, researchers and other practitioners can analyze the data to better understand if and when adjustments in protocol or formulation are necessary. The smart inhaler system thus creates a critical loop of communication to improve treatment efficacy by eliminating any delay of information provided by the patient.
The smart inhaler system incorporates multiple sources and methods in the gathering of relevant data and perform analytics regarding the patient's inhaler use, physical status and medical condition. The system incorporates vitals gathered from ancillary and add-on components that capture data, such as but not limited to, patient heart rate, blood pressure, body temperature, respiration rate, glucose monitoring, blood oxygen level, sleep patterns, exercise/activity patterns and weight monitoring. The device system will incorporate all forms of data, feedback and information into the patient's account folder on the system network for review by the physician and formulator. The device system software will also incorporate artificial intelligence (Al) that will analyze and process the patient data in order to provide predictive modeling and make recommendations in regards to potential patient treatment regimes, adjustments in dosing and formulations to increase efficacy and increase assurance in Physicians and Formulators that the proper treatment is being provided to the patient. Physicians may also upload patient clinical test data to the device system to increase the accuracy of the Al analytics. This clinical test data may include but is not limited to, blood test data, cardiovascular test data, MRI/CAT scan test data, and genome test data.
Physicians may use the Al results and per-dose, typically real-time data collected by the smart inhaler system to make instant modifications to the patient's dispensing amount and the frequency of the dispensing to improve treatment outcomes. The access to real-time data also allows the physician to monitor the dispensing device use and confirm if the patient is adhering to the prescribed regimen. The centralized information database created by the smart inhaler system will allow physicians to access patient and Al input and determine which formulators are producing the medicines with the highest efficacy rates and allow physicians to make a recommendation based on accurate data instead of making a random decision in selecting a medicine. Providing real-time patient feedback that is accessible to the formulators and incorporating Al results is invaluable in ensuring their medicines are compounded to target specific ailments. This user feedback and Al data allows the formulator to determine adjustments that are required to eliminate unwanted side effects of a medicine. There are no current methods or database resources for formulators to understand how their medicines are benefiting or negatively affecting users. The smart inhaler system will allow formulators to analyze user data, incorporate Al recommendations and make necessary changes to optimize and improve their medicines. The device in combination with the network software will allow formulators and physicians a very quick and efficient product recall capability in the event that a medicine needs to be recalled. The formulator can issue an electronic recall notice that will lock-out further use of the device utilizing the medicine to be recalled. Detailed electronic messaging can be sent to patients and doctors notifying them of the recall event.
The smart inhaler is a battery powered hand-held device that is slightly larger than a traditional inhaler product. It is familiar in appearance to a traditional inhaler with regards to the mouthpiece where the medicine is dispensed. The smart inhaler has a reusable main upper housing that provides an enclosure for the electronic components. The larger size is directly related to the space required for housing the device electronics and power supply. The device has as an internal PCB with a microprocessor, Bluetooth chip set, NFC antenna and/or RFID reader, battery charging circuitry, rechargeable battery, LED status indicators and other surface mounted components for completing the electronic system design. The device will connect to a smartphone and/or tablet to communicate with the software application. The device will incorporate electronic features and functions such as but not limited to; detection of dispensing events, preprogrammed dispensing event times, data log of dispensing events, alerts and notifications of dispensing events, visual/tactile/audible device status indicators, low power consumption/sleep mode and an accelerometer. The device may or may not have a power “On/Off” switch and may or may not always remain in a state of “On, Standby or Sleep mode”. The software also has the capability to gather and aggregate information from third party smart devices such as Fitbit®, Apple Watch®, Garmin® watches and other smart information gathering devices. The information gives additional channels of information to the physician such as heart rate, sleep patterns, activity levels that can be combined with the patient's real-time feedback to develop a holistic understanding of how the treatment plan is working for the patient.
The smart inhaler has a removable and disposable lower housing that incorporates the valve stem, valve and jet features for properly dispensing the MDI canister medicine, a mouthpiece where the medicine exits the housing and a mating feature to secure the MDI canister into the lower housing. In traditional inhalers, the MDI canister is inserted from the top of the actuator. The smart inhaler differs in this and the MDI canister is attached to the lower housing and the assembly is inserted into the bottom of the device. The lower housing is removable and replaceable to the upper housing by means of a snap-fit feature. This feature engages with the pump unit (also called the “upper housing”) by aligning and pressing the lower housing (also referred to as the or “mouthpiece unit” or “cartridge” when the mouthpiece unit is carrying a canister) into position. The lower housing may be disengaged and removed by pressing side tabs to release the snap-fit allowing the two parts to separate and pull apart the housings. The lower housing of the smart inhaler also has a feature that secures the MDI canister into the housing by means of a permanent snap fit. This feature allows the canister to be pressed into the lower housing for dispensing until the canister contents are depleted. The empty canister and lower housing are both discarded and a new canister/lower housing assembly can be installed into the upper housing. When the canister has been permanently secured into the lower housing and subsequently and forcefully removed from the lower housing, the permanent snap feature that secures the canister will be deformed and/or destroyed to the extent that the canister cannot be installed into the lower housing to be reused. This feature is to ensure that the lower housing is discarded after the canister contents are depleted for sanitary purposes and also to prevent other manufacturer's canisters from being inserted into the lower housing and reused ion the smart inhaler. The lower housing assembly is equipped with on-board memory storage that is capable of storing and containing information such as, but not limited to, canister contents, contents manufacturer, manufactured date, lot number, batch number, expiration date, etc. The memory component may be incorporated into the lower housing, lower housing assembly or the MDI canister. When the lower housing assembly is inserted into the upper housing, the upper housing PCB is equipped with a component to wirelessly read the data stored on the lower housing. The upper housing detects the installation of the lower housing, collects the information from the lower assembly and ports this data wirelessly to the smartphone app. The information can be viewed by the user on the smartphone app and viewed by the physician and formulator on the central network. Each time the lower housing is removed or inserted, the device will log this event. If a lower assembly with medicine “A” is inserted and dispensing events occur, the device will record and store these events to track consumption for that specific medicine. When medicine “A” is reinserted the device will resume counting dispensing events for Medicine “A” and continue counting until the canister is depleted. As the lower housing assembly with Medicine “A” approaches depletion, approximately 100 dispensing events, the device will send a notification to the smartphone app and alert the patient and/or physician that the MDI canister is almost empty. This advance notification allows the patient to ensure they have an immediate refill on-hand to replace the depleted canister or allows them the time to contact the physician for a prescription refill if required. The device app and software can automatically notify the prescribing physician that the patient's prescription is almost empty. The patient can then directly request a prescription refill by using the smartphone app. This system feature avoids patients from having to spend the extra money for an office visit with their doctor and also avoids the time required for this visit. In turn, the physician can review the patients adherence and feedback using the online system network to ensure the patient is progressing satisfactorily prior to authorizing the prescription refill. Once approved by the physician, the prescription is automatically send to the patient's dispensary and a message is sent to the patient when the prescription is ready for pick up. The physician can also reject the refill request and instruct the patient to schedule an in office visit for an evaluation.
The reusable upper housing of the device has a integrated dispensing button that interfaces with the canister when the lower assembly is installed. With traditional inhalers, the patient presses down on the actual canister to dispense, whereas in the smart inhaler, the user will press down on the dispensing button that forces the canister down in order to dispense. The upper housing has an internal function that can be controlled to allow the button to be pressed down or prevent the button from being pressed down to avoid accidental or unauthorized dispensing. A mechanical feature will engage with the dispensing button to create an interference of the up and down movement of the button and essentially positioning the button in a state of non-function. This function is controlled electronically via commands sent from the system application installed on a smartphone. The device and/or app can be programmed for individual dispensing events. When the dispensing event approaches, the button engagement feature will disengage allowing the user to dispense a pre-set amount. When the dispensing is completed the button engagement feature will re-engage the button to prevent dispensing. There may be a preprogrammed window of time allowing the patient to dispense the medicine at their convenience. For example, the time to dispense is set for 3:00 PM, the device would disengage the dispensing button at 2:30 PM and remain disengaged until 3:30 PM, allowing the patient to take their medicine anytime within the 1 hour window. At 3:31 the dispensing button would be re-engaged to prevent the dispensing event until the next programmed event. The device app may or may not allow the user to override the dispensing button engagement by entering a passcode to disengage the button during times other that the preprogrammed dispensing events. For example, the patient realizes at 3:45 PM that the pre-programmed dispensing event was overlooked, a password code can be entered to immediately disengage the dispensing button for a short period, approximately 1-3 minutes, allowing the patient to take the previously overlook dispensing event. When a pre-programmed dispensing event is approaching, a notification will be activated. This notification may be in the form of an audible, visual and/or tactile (vibration) alert. The notification may also be in the form of an email, text or in-app alert on the users smartphone. This notification may be a combination of any of the above mentioned methods. When the dispensing event time window has been initiated, the dispensing button is disengaged and a countdown clock begins and is displayed on the smartphone app. This allows the patient to see how much time is remaining prior to the re-engagement of the dispensing button. This feature has been created to assist parents and caregivers to both monitor and ensure children do not exceed dosing quantities and helps reinforce the treatment regimen. There may be an app feature allowing the patient to extend the dispensing time window or reschedule the dispensing event to a time that is more convenient. The same mechanical feature that engages the dispensing button, can also engage the lower housing assembly to prevent removal. The lower housing may have a feature that extends up into the main housing when installed. This extended detail, or tab, allows the mechanical feature to engage the tab and prevent the lower assembly from being removed from the main housing. When the canister contents are depleted, the smart inhaler will disengage the tab and allow the user to remove the lower assembly.
During the examination of a patient, a physician determines that MMJ is a suitable alternative to addressing the patients ailments caused by Crohn's disease. The physician recommends the smart inhaler as the method of delivery for the MMJ. The physician logs into the online system network to access his assigned dashboard. The physician can browse various categories of information. One category may be “Patient Ailments”, where numerous ailments are listed, such as but not limited to: ADHD, Alzheimer's, Arthritis, Cancer, Crohn's Disease, etc. The physician selects “Crohn's Disease” and a page of medicines specifically formulated for Crohn's is displayed. With each individual formulation listed, detailed information may be displayed such as but not limited to: Manufacturer/Formulator of Record, formulation contents, percentages and types of cannabinoids and THC, last date of formulation revision, ect. . . . Also displayed with each individual formulation is patient group feedback for that specific formulator's medicine. This data may be used by the physician is guiding his decision on which formulation to recommend. The group sourced feedback may provide information on formulation effectiveness, side effects, dispensing levels and dispensing frequency, likes/dislikes, etc. Patients may also have the ability to rate formulations on a scale of 1 to 5 to assist in establishing a method for “scoring” how successful formulators are at addressing ailments with their medicines. This scoring will allow physicians to quickly see which formulator is focused on providing the best results with their specific medicines. For example, the physician has 6 formulator's to select from with regards to medication for Crohn's disease. 4 of the six formulator's have a rating of less than 3 stars, 1 has a 3.4 stars and the remaining 2 have scores above 4 stars. The doctor can select the 2 highest ranked formulators and do a side by side product comparison, read patient feedback, and now make an educated decision on which formulator's medicine is best for his patient's specific ailment. The physician selects “Formulator #6” and a list of local dispensaries carrying that specific medicine is displayed allowing the physician to select a dispensary that is convenient for the patient. Next, a window may be displayed for the physician to enter the recommended dispensing regime for his patient. Information such as but not limited to, medicine dispensing amounts, dispensing frequency, treatment duration, approved refills, etc. will be entered and stored into the on-line system. When the prescription is entered, a unique ID code is generated and attached to an electronic prescription that is emailed to the patient or authorized guardian. The patient visits the dispensary and presents the e-prescription to be filled. The patient purchases the dispensing device and the prescription.
In order to use the dispensing device, the patient is first required to download and install the free smartphone application from Google Play® or the Apple Store® and the device's batteries must be fully charged. Once this is completed, the smartphone's Bluetooth wireless communication interface must be turned on. Bluetooth will search and detect the device and connect. The patient will open the device application and will be asked to complete some basic information, such as but not limited to: name, address, age, weight, etc. The patient will also be required to read and agree a “private information disclosure” that will allow for specific personal information to be gathered and synthesized from a HIPPA compliant database on the system network. Additional syncing of third party device collection methods such as Fitbit, Apple Watch etc. can be completed at this time. After this is completed, a “Device Manual and Patient Instruction” section will walk the patient through the device features and functions, how to use the device, how to install the MDI cartridge, how to dispense the medicine, FAQ's, troubleshooting, etc. Next, the patient will install the MDI canister. The app will instruct the user to place the MDI cartridge into the bottom of the main housing and slide up until the canister assembly locks into place. When the canister is being installed the device will detect this action and via the smartphone, prompt the user to enter the unique ID code that was included with their electronic prescription. When the code is entered, the system software will download the treatment regime recommended by the physician to the smartphone and then wirelessly transfer and flash this information to the device's memory. For example, the physician's recommendation is for the patient to dispense 6 mg or medicine every 4 hours. The device is now programmed to monitor, track and notify the patient for content dispensing according to the physician's recommendation. Also, when the canister is installed the device will wirelessly read the data stored on the canister assembly regarding the formulator of record, contents, date manufactured, etc. This information is uploaded in real-time to the on-line system network and is accessible by the physician and formulators. The device is ready for use and may remain disengaged until the first dispensing event is recorded. When the patient administers their first dispensing from a new canister, the device's internal clock starts and will notify the patient when the next dispensing event is required in 4 hours. For patient reference, a daily dispensing schedule may be displayed on the smartphone outlining the times throughout the day that a dispensing event should occur. After the initial dispensing of the new canister is complete, the device will engage the dispensing button preventing additional or accidental dispensing until the next scheduled dispensing event. The device will go into a sleep mode until the next dispensing event is approaching and at this time, the device will wake-up and vibrate and/or flash the LED indicator to notify the patient. The smartphone app can also simultaneously notify the patient through an audible alarm, vibration and/or screen message. The app will allow the patient to determine a window of time that the dispensing event can occur. This time can be adjusted and set for 15 to 30 minutes before and after the designated time. When a dispensing event is authorized and the time to dispense is within the set window of time, the device will continually send periodic reminders to the patient that the dispensing event needs to occur. A countdown timer may be displayed on the smartphone with the remaining time before the dispensing event window has expired. If the patient is in an inconvenience location, for example a client meeting at work, the patient may postpone the dispensing event for a future time prior to the next scheduled dispensing event. During an active dispensing event time window, the device's dispensing button will stay engaged and the device's LED indicator will flash green until the patient shakes the device and canister 5 or more times to mix the canister contents. The device's internal accelerometer detects this action and the LED indicator will change to a solid green and the dispensing button will disengage allowing the patient to press down the button and dispense the medicine. After the dispensing event has occurred the button is engaged and the device returns to a sleep mode. At any time between dispensing events, the patient can shake the device to force an exit from the sleep mode. After each dispensing event, the app will prompt the patient to answer a set of questions relating to the effects of the medicine. The patient will input their feedback and this information will be uploaded to the on-line system network in real-time for review by the physician and/or the formulator. This direct patient feedback is beneficial to the physician to ensure the prescribed regime is providing benefit to the patient and also allows the physician to monitor any negative side effects experienced by the patient. The formulator can also analyze the patient feedback to better understand the efficacy of the medicine they produce. This patient feedback can be used by the formulator to make adjustments to specific medicine chemistry. For example, a high number of Crohn's disease patients may be using a formulation to address their symptoms but 2 hours after a dispensing event, the pain has returned, they are experiencing sleepiness by midday and their anxiety levels are increasing. The formulator can then make necessary adjustments to address and/or eliminate these side effects and improve the effectiveness of this specific formulation for Crohn's patients. The device will track the total number of dispensing events for each individual canister. For example, a canister with a Crohn's disease formulation has incurred 60 dispensing events and is removed from the device and a new, nighttime formulation to help a patient sleep is inserted and incurs 2 dispensing events. The next morning, the patient removes the nighttime formulation and reinserts the Crohn's formulation, the device will count the next dispensing as event #61. The onboard memory located in the lower assembly (mouthpiece and canister) allows the device to recognize and track each individual formulation that is inserted/removed from the device. When a canister's contents have been depleted, the app will notify the user to remove the lower assembly and install a new canister.
An additional example of the device system in use could be for patient suffering from PTSD. Shortly prior to the time of dispensing the medicine at a scheduled time, the device system will instruct the patient to ensure their ancillary monitoring device, such as a FitBit, is on the patient's wrist. The system device may instruct and notify the user to initiate a blood pressure check at a specific time, for example, 5 minutes prior to the scheduled dosing time. The blood pressure device may be bluetooth enabled and the device system will automatically import the test results or the user may manually enter the results into the smartphone app of the smart inhaler system. The device system may also instruct the user to connect an ancillary blood oxygen monitor to their smartphone and clip the monitor to their finger tip 2-3 minutes before the dosing event. All of the data is captured prior to the dosing event and stored on the device system. The patient is then instructed to dispense the medicine. At specific time intervals following the dosing event, patient vitals and data will be monitored, automatically or manually entered and recorded by the device system. For example, the patient has a schedule doing event for 2:00 p.m., the device system sends a notification alert at 1:50 p.m. for the user to ensure their FitBit is charged and is on their wrist. The device system will instruct the user to sit, rest and refrain from any activity so that a resting heart rate can be obtained. Upon user confirmation, the device system begins to record the user's heart rate via input from the FitBit. At 1:55 p.m. the device system will instruct the user to take a blood pressure reading. The blood pressure test is performed and the system device will import the results from a Bluetooth enable blood pressure monitor or the user can manually input the results into the device system app, for example, 135/90 is typed and entered by the user into the device system's smartphone app. The device system may then send a notification to the user at 1:59 p.m. to connect an ancillary blood oxygen monitor an place the monitor's clip on the user's index finger. Now the device system has gathered and is continuously recording patient vitals prior to dosing. At 2:00 p.m. the device system notifies the patient it is time to dose their medication as prescribed by the physician. The patient dispenses the medication and the event is recorded by the device system and the post-dosing monitoring software program is initiated. The system device will continue to record vitals at specific time intervals. For example, the heart rate data is captured and recorded every 30 seconds for minutes 1-5 after dosing and then the device system captures and records the heart rate every 60 seconds for minutes 6-15. The system device may then instruct the user to take and enter a second blood pressure reading at the 5 minute mark after dosing and again at the 15 minute post-dosing mark. The blood oxygen monitoring may occur in a similar fashion as the heart rate monitoring and at specific time intervals, the readings will be captured and recorded in the device system. The post-dosing monitoring may only occur for the first 15 minutes after the dosing event or, depending on the patient's needs as determined by the physician, the post-dosing monitoring could may need to continue for the first 30 minutes after patient dosing and then for 15 minutes every hour until the next scheduled dosing event. The device system now has multiple patient data points to compare, analyze and categorize. The post-dosing patient monitoring period and the time in-between monitoring cycles is customizable according to the patient's medical needs. The patient monitoring system intervals may be provided in a device system default configuration, or be determined and adjusted by the physician, or automatically adjusted by Al analyzing patient vitals history and making recommendations based on patient treatment progress. Through the combination of using the smart inhaler, ancillary vital monitoring devices, capturing and recording patient vitals (pre and post-dosing) and using Al for predictive modeling, physicians and medicine formulators can make huge strides in improving individual treatment plans for patients and patient groups suffering from similar ailments.
The present disclosure may be implemented using a smart metered-dose inhaler that operated in concert with apps running on one or more mobile communication devices (e.g., smartphones) one or more network-based or cloud-based platforms. Each of these devices includes a controller utilizing a general purpose computing device, such as a microprocessor controlled by specialized computer software. As such, embodiments of the disclosure may comprise adapting or reconfiguring presently existing equipment. Alternatively, original equipment may be provided embodying the disclosure.
All of the methods described in this disclosure may include storing non-transient computer-executable instructions and associated results in a non-transient storage medium. These computer-executable instructions and results may include any of the computer-implemented procedures or results described in this disclosure and may be stored in any manner known in the art. The storage medium may include any storage medium described in this disclosure or any other suitable storage medium known in the art. After the computer-executable instructions or results have been stored, they can be accessed in the storage medium and used by any of the method or system embodiments described in this disclosure, formatted for display to a user, used by another software module, method, or system, etc. Furthermore, the results may be stored “permanently,” “semi-permanently,” temporarily, or for some period of time. For example, the storage medium may be random access memory (RAM), and the results may not necessarily persist indefinitely in the storage medium.
Those having skill in the art will appreciate that there are various vehicles by which processes and/or systems and/or other technologies described in this disclosure can be effected (e.g., hardware, software, and/or firmware), and that the preferred vehicle will vary with the context in which the processes and/or systems and/or other technologies are deployed. For example, if an implementer determines that speed and accuracy are paramount, the implementer may opt for a mainly hardware and/or firmware vehicle; alternatively, if flexibility is paramount, the implementer may opt for a mainly software implementation; or, yet again alternatively, the implementer may opt for some combination of hardware, software, and/or firmware. Hence, there are several possible vehicles by which the processes and/or devices and/or other technologies described in this disclosure may be effected, none of which is inherently superior to the other in that any vehicle to be utilized is a choice dependent upon the context in which the vehicle will be deployed and the specific concerns (e.g., speed, flexibility, or predictability) of the implementer, any of which may vary. Those skilled in the art will recognize that optical aspects of implementations will typically employ optically-oriented hardware, software, and or firmware.
Those skilled in the art will recognize that it is common within the art to describe devices and/or processes in the fashion set forth in this disclosure, and then use engineering practices to integrate such described devices and/or processes into data processing systems. That is, at least a portion of the devices and/or processes described can be integrated into a data processing system via a reasonable amount of experimentation. Those having skill in the art will recognize that a typical data processing system generally comprises one or more of a system unit housing, a video display device, a memory such as volatile and non-volatile memory, processors such as microprocessors and digital signal processors, computational entities such as operating systems, drivers, graphical user interfaces, and applications programs, one or more interaction devices, such as a touch pad or screen, and/or control systems including feedback loops and control motors (e.g., feedback for sensing position and/or velocity; control motors for moving and/or adjusting components and/or quantities). A typical data processing system may be implemented utilizing any suitable commercially available components, such as those typically found in data computing/communication and/or network computing/communication systems. All of the technology described in this disclosure is suitable for implementation using commercially available computing devices, such as microprocessors executing computer-executable software. These computing devices may be interconnected via the Internet, mobile telephone voice and data system, or other data suitable network.
This disclosure sometimes illustrates different components contained within, or connected with, different other components. It is to be understood that such depicted architectures are merely exemplary, and that in fact many other architectures can be implemented which achieve the same functionality. In a conceptual sense, any arrangement of components to achieve the same functionality is effectively “associated” such that the desired functionality is achieved. Hence, any two components may be combined to achieve a particular functionality can be seen as “associated with” each other such that the desired functionality is achieved, irrespective of architectures or intermediate components. Likewise, any two components so associated can also be viewed as being “connected”, or “coupled”, to each other to achieve the desired functionality, and any two components capable of being so associated can also be viewed as being “functionally connected” to each other to achieve the desired functionality. Specific examples of functional connection include but are not limited to physical connections and/or physically interacting components and/or wirelessly communicating and/or wirelessly interacting components and/or logically interacting and/or logically interacting components.
While particular aspects of the present subject matter have been shown and described in detail, it will be apparent to those skilled in the art that, based upon the teachings of this disclosure, changes and modifications may be made without departing from the subject matter described in this disclosure and its broader aspects and, therefore, the appended claims are to encompass within their scope all such changes and modifications as are within the true spirit and scope of the subject matter described in this disclosure. Although particular embodiments of this disclosure have been illustrated, it is apparent that various modifications and embodiments of the disclosure may be made by those skilled in the art without departing from the scope and spirit of the disclosure.
It is believed that the present disclosure and many of its attendant advantages will be understood by the foregoing description, and it will be apparent that various changes may be made in the form, construction and arrangement of the components without departing from the disclosed subject matter or without sacrificing all of its material advantages. The form described is merely explanatory, and it is the intention of the following claims to encompass and include such changes. The disclosure is defined by the following claims, which should be construed to encompass one or more structures or function of one or more of the illustrative embodiments described above, equivalents and obvious variations. it will therefore be appreciated that present invention provides significant improvements in electric power circuit reclosers. The foregoing relates only to the exemplary embodiments of the present invention, and that numerous changes may be made therein without departing from the spirit and scope of the invention as defined by the following claims.
Claims
1. An electronic metered-dose inhaler system including security features comprising a cartridge, a pump unit, and a mobile app, wherein:
- the cartridge comprises: a canister containing pressurized contents for aerosol dispensing without burning or vaporizing the contents of the canister, a mouthpiece unit holding the canister against a spring biasing the canister in a retraction direction allowing the canister to be reciprocated between the retraction direction and an opposing insertion direction to dispense a portion of the contents of the canister through the mouthpiece unit each time the canister is reciprocated,
- the pump unit comprises: a pump actuator positioned to reciprocate the canister to dispense the contents of the canister through the mouthpiece unit when the cartridge is attached to the pump unit in the operational configuration; a battery powering a microprocessor, a memory, and a wireless radio; wherein the memory is operative for storing the security information and associated security procedures; wherein the microprocessor is operative for unlocking the pump actuator to allow operation of the pump actuator in accordance with the security procedures and security information, and for locking the pump actuator to prevent operation of the pump actuator that is not in accordance with the security procedures and security information;
- wherein the mobile app is configured to run on a mobile device associated with a user configured to pair and communicate with the microprocessor of the pump unit, and
- wherein the mobile app is configured to communicate with other systems over a network and execute computer instructions comprising: receiving pre-dose authorization information from the pump unit, validate pre-dose authorization, unlocking inhaler for an a dose, entering the inhaler into a locked-out state in response to determining that required post-dose feedback was not received or that received post-dose feedback raises a suspicion of fraudulent or improper use.
3. The electronic metered-dose inhaler system of claim 1, further comprising activating an alarm displayed or played by the mobile device in association with entering the inhaler into the locked-out state.
4. The electronic metered-dose inhaler system of claim 1, further comprising activating an alarm displayed or played by the pump unit in association with entering the inhaler into the locked-out state.
5. The electronic metered-dose inhaler system of claim 1, further comprising transmitting a notification from the mobile device to an cooperating system over the network in association with entering the inhaler into the locked-out state.
6. The electronic metered-dose inhaler system of claim 5, wherein the cooperating system is associated with a prescriber of a medication in the canister.
7. The electronic metered-dose inhaler system of claim 5, wherein the cooperating system is associated with a clinical trial administrator associated with a substance in the canister.
8. The electronic metered-dose inhaler system of claim 5, wherein the cooperating system is associated with a law enforcement agency.
9. The electronic metered-dose inhaler system of claim 5, wherein the cooperating system is associated with a parent, guardian or care taker of an authorized used of a substance in the canister.
10. The electronic metered-dose inhaler system of claim 1, wherein the step of entering the inhaler into a locked-out state comprises determining that required post-dose feedback was not received.
11. The electronic metered-dose inhaler system of claim 1, wherein the step of entering the inhaler into a locked-out state comprises:
- analyzing received post-dose feedback; and
- determining that the post-dose feedback raises a suspicion of fraudulent or improper use of the inhaler.
12. The electronic metered-dose inhaler system of claim 1, wherein the required post-dose feedback comprises feedback required during a predefined time interval.
13. The electronic metered-dose inhaler system of claim 1, wherein the required post-dose feedback comprises feedback required during a plurality of predefined time intervals.
14. The electronic metered-dose inhaler system of claim 1, wherein the required post-dose feedback comprises a bio-identifier entered into the mobile device.
15. The electronic metered-dose inhaler system of claim 1, wherein the required post-dose feedback comprises a password entered into the mobile device.
16. The electronic metered-dose inhaler system of claim 1, wherein the required post-dose feedback comprises a registration number entered into the mobile device.
17. The electronic metered-dose inhaler system of claim 1, wherein the required post-dose feedback comprises interactive feedback conducted with a cooperating system over the network.
18. The electronic metered-dose inhaler system of claim 1, wherein the required post-dose feedback comprises a photograph taken with the mobile device.
19. The electronic metered-dose inhaler system of claim 1, wherein the required post-dose feedback comprises a user's assessment of efficacy of a substance in the canister.
20. The electronic metered-dose inhaler system of claim 1, wherein the required post-dose feedback comprises a user's assessment of side effects caused by a substance in the canister.
Type: Application
Filed: Sep 12, 2019
Publication Date: Jan 2, 2020
Inventors: David N. Jackson (Flowery Branch, GA), Russell M. Smith (Flowery Branch, GA)
Application Number: 16/569,463
