Self contained monitor and system for use

Inventors

VORSTER, Werner

Assignees

Vitls Inc

Publication Number

US-12343165-B2

Publication Date

2025-07-01

Expiration Date

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Abstract

A wearable device and methods for providing a wearable device are disclosed. In a first aspect, the wearable device comprises at least one power source, one computer controller and a plurality of instruments that when worn on a user access physiological data from at least the user axilla. The wearable device monitors one or more or a combination of body temperature, pulse, R-R interval, respiration rate, pulse ox (SpO2), sleep, movement included fall detection. The device stores, processes and communicates collected or processed data to an external computer system. A software system provides summary information, reporting and alarms based on data collected by the one or more instruments.

Core Innovation

A wearable device is provided that is removably attachable to a user and comprises an enclosure having a first end, a second end and a flexible portion extending between the first end and the second end, wherein a plurality of different instruments positioned within the ends access physiological data from at least the user axilla. The wearable device monitors one or more or a combination of body temperature, pulse, R-R interval, respiration rate, pulse ox (SpO2), sleep, movement including fall detection, stores, processes and communicates collected or processed data to an external computer system, and a software system provides summary information, reporting and alarms based on data collected by the one or more instruments.

The invention addresses a need for improvements in wearable device technology to provide better remote user monitoring by enabling constant or continuous monitoring while allowing user comfort and mobility compared to traditional sensor devices. The device is configured so at least a portion is positioned in the axilla to mitigate optical interference and motion artifact, and includes on-board processing and communications to transmit data to remote systems for monitoring, alerts and clinician interaction.

Claims Coverage

This claim set is led by one independent method claim and the main inventive features are summarized in four items.

Device structure and attachment

A device having a first end (main board) and a second end (sensor board) connected by an intermediate flexible portion, with a bottom surface of the first end, second end, and intermediate flexible portion comprising an adhesive, the intermediate flexible portion curving around a curve of the chest and transferring data between the sensor board and the main board.

Axilla positioning indicator

Use of an indicator on the second end to position a portion of the second end on an axilla of the user and removably attaching the device so the first end extends into a chest of the user.

Physiological parameter monitoring

Monitoring one or more physiological parameters including body temperature, heart rate, heart rate variability, RR interval, respiration rate, blood oxygen levels (SpO2), blood pressure, cardiac output, body fluid analysis, sleep cycles, movement and proximity of the device to the skin of the user.

Data processing and remote transmission

Executing machine executable instructions configured to cause the device to send user data to a remote database.

The independent claim covers a removably attachable, two-ended wearable device with a flexible intermediate connector and adhesive bottom surfaces, an axilla positioning indicator, on-board sensing of multiple physiological parameters, and on-device execution of instructions to transmit collected user data to a remote database.

Stated Advantages

Continuous monitoring that can reduce workload and human error by providing constant data rather than intermittent spot checks.

Improved accuracy and reduced motion artifact by placing sensors in the axilla and combining primary and secondary signals.

User comfort and unobtrusive wearability enabling movement and reduced irritation through flexible form factor, adhesive placement, and biocompatible enclosure materials.

Ability to process, store and communicate data to external systems with summaries, reporting and alarms to support clinical workflows and alerts.

Non-invasive monitoring capability including a described approach for noninvasive cardiac output monitoring via optical sensing and pulse contour analysis.

Improved clinical workflow and early detection potential across care settings by enabling continuous remote monitoring and alerting.

Documented Applications

Continuous monitoring of patients in a hospital emergency department to enable triage and early detection of deterioration.

Continuous monitoring of patients on general hospital floors to reduce intermittent spot checks and associated workflow burdens.

Monitoring postoperative patients at risk of developing respiratory complications during the post-surgery period.

Monitoring postsurgery patients at risk for sepsis to detect indicators of possible infection.

Monitoring chronically ill patients to allow increased mobility and participation in rehabilitation while continuously tracking vitals.

Monitoring blood volume in women giving birth and general surgery patients to detect significant changes in blood volume and blood loss.

Noninvasive cardiac output monitoring through pulse contour analysis using increased optical sensor sampling to monitor blood flow characteristics.

Telehealth monitoring where patients wear the device prior to a telehealth visit to provide real-time data to clinicians.

Monitoring pilots for hypoxia during flight to provide alerts for low oxygen levels.

Monitoring wounded soldiers in the field to provide medics with real-time vital signs prior to evacuation.

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