Medication adherence apparatus and methods of use
Inventors
Sirdeshmukh, Deepak • Wiegandt, Nestorius • Krishnamurthy, Ashok Kumar • Kokal, James Vincent • Benkowski, Robert • Oliver, Javier • Benkowski, Laurent Gregoire
Assignees
Designplex Biomedical LLC • Sensal Health LLC • Sensal Health LLC
Publication Number
US-11826314-B2
Publication Date
2023-11-28
Expiration Date
2039-10-10
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Abstract
Provided herein are systems, methods and apparatuses for a medication adherence apparatus and methods of use. A method of adhering to medical prescription requirements combines sensors and hardware to record a cap state including an orientation, temperature, time stamp, and location of a cap device to enhance a patient's adherence to medical prescription when operably coupled with a computing device.
Core Innovation
The invention provides systems, methods, and apparatuses for a medication adherence apparatus and methods of use. It integrates a cap device operably coupled with a container element that houses medication, combining sensors and hardware to record a cap state including orientation, temperature, time stamp, weight, and location of the cap device. This cap device detects the presence or absence of the container, measures its weight, and monitors orientation and movement to determine if the medication container is properly used, thereby enhancing a patient's adherence to medical prescriptions.
The medication adherence apparatus solves the problem of low patient adherence to outpatient prescriptions, where only about 20% of outpatients follow medical instructions properly, despite the known benefits of therapy adherence in reducing lifetime healthcare costs and improving therapeutic outcomes. The apparatus overcomes the challenge that patients desire to adhere but are unwilling to undertake additional burdens or modify behavior, by providing a hardware system that unobtrusively collects adherence data and communicates it in real time to patients and doctors for monitoring and feedback.
The apparatus comprises a container element of various forms including ointment tubes, plastic jars, or other medicament storage platforms, combined with a cap device featuring multiple sensors such as force sensors, orientation sensors, temperature sensors, and proximity sensors. The cap device records cap state data including the weight of the container, temperature inside the container's mouth, whether the container is attached, its orientation, and movement along multiple axes. This data is stored or transmitted via a wireless module to a mobile or computing device, where an application processes adherence schedules and sends notifications or alarms to improve compliance.
The system architecture includes the cap device hardware, a mobile application communicating via Bluetooth Low Energy protocol, and web/cloud servers for data storage and management. The mobile application monitors medication consumption, produces alerts, and facilitates patient surveys. The web system supports personalized communications and predictive analytics for adherence trends, allowing clinical research organizations and doctors to manage and monitor patient adherence effectively and securely with data encryption and HIPAA compliance.
Claims Coverage
The patent includes two independent claims that describe medication adherence apparatuses comprising a container element and a cap device with multiple sensors and notification functionality.
Medication adherence apparatus with sensor-integrated cap device
An apparatus comprising a container element operably and detachably coupled to a cap device that includes a force sensor to measure container weight, an orientation sensor to detect cap orientation, a temperature sensor to detect temperature inside the container, and a proximity sensor to detect cap on and off states. The cap device receives medication schedules and notification parameters to alert patients if doses are missed, with alarms including audio, visual, electronic, or cellphone notifications. Upon detecting a change from cap off to cap on, the orientation sensor checks if the cap is upright and not moving before the force sensor measures weight. If the cap is not upright, the device notifies the patient to correct orientation, checks repeatedly, and creates datasets without weight if upright orientation is not achieved.
Cap device with mechanical and sensor components for ointment container
An apparatus comprising a container holding ointment and a detachable cap device including a force sensor to measure container weight, an orientation sensor, and a proximity sensor to detect cap state. The cap device detects changes from cap off to cap on state, verifies upright orientation and lack of movement before measuring weight, and notifies the patient to correct orientation if not upright. If upright is not detected after multiple checks, a dataset is created excluding weight measurement. The cap device includes a connector portion with a central lumen and threaded inner surface to couple with a container such that no container part extends beyond an internal floor. A cavity houses the sensors and battery disposed between the container and battery.
The independent claims cover a medication adherence apparatus featuring a sensor-equipped cap device that monitors container weight, orientation, temperature, and cap state; provides patient notifications based on medication schedules; and employs a mechanical design to securely couple with varying container types. Together, these inventive features enable enhanced monitoring of medication adherence through hardware and software integration.
Stated Advantages
The medication adherence apparatus increases patient adherence to medical prescriptions, thereby improving therapeutic outcomes and reducing lifetime healthcare costs.
The system provides real-time feedback to both patients and doctors, enabling objective monitoring of patient compliance and timely adjustment of prescription behavior.
The apparatus requires no additional action or behavioral change from patients, thereby addressing patient reluctance to undertake extra burdens.
The cap device’s integrated sensors accurately record multiple parameters including weight, orientation, temperature, and cap state to robustly monitor medication usage.
Communication with mobile and web applications enables personalized alerts, adherence reporting, and predictive analytics to support clinical management.
The system employs security measures including encryption and password protection to comply with data privacy regulations such as HIPAA.
Documented Applications
Monitoring outpatient prescription medication adherence to improve patient therapeutic outcomes and reduce healthcare costs.
Use with various container types for medications including ointment tubes, plastic jars, pills, powders, liquids, or gases.
Integration with mobile devices for patient alerts and notifications when medications are missed or not properly administered.
Use by clinical research organizations for managing patient adherence in clinical trials, including setting medication schedules, surveys, and data reporting.
Real-time monitoring and feedback accessible by treating doctors via web servers to objectively assess and manage patient compliance.
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