Self contained monitor and system for use

Inventors

VORSTER, Werner

Assignees

Vitls Inc

Publication Number

US-11622718-B2

Publication Date

2023-04-11

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 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, and 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.

The wearable device 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 the detection envelope is a portion of an axilla of the user. At least a portion of the second end of the enclosure can be adapted and configured or shaped so as to correspond to one or more than one anatomical landmark or feature of the axilla so as to aid in the correct placement of the wearable device for monitoring one or more physiological parameters of the user detectable from the site in the axilla of the user. The device can include an optical array, secondary instruments such as an accelerometer, communications modules, and various PCBs, and may have a dogbone shape with adhesive on bottom surfaces of the ends to couple to the skin.

Claims Coverage

Independent claims identified: claim 1 (wearable device) and claim 28 (method of monitoring a user). The following inventive features are extracted from those independent claims.

Enclosure with first end, second end, and flexible portion

An enclosure having a first end comprising a first plurality of instruments including a communications module configured to transmit sensed data to a remote device, a second end comprising a second plurality of instruments including an optical sensor adapted to monitor at least one physiological parameter of the user, and a flexible portion extending between the first end and the second end.

Positioning of first end in axilla

The wearable device is removably attachable to a user to position the first end in at least a portion of the axilla.

Adhesive on bottom surfaces of ends only

A bottom surface of only the first end and the second end comprises an adhesive.

Optical sensor adapted for axilla monitoring

An optical sensor located on the second end and adapted to be positioned on or near an axilla of the user and configured to monitor at least one physiological parameter of the user, including SpO2 and respiration rate when positioned in the axilla.

Dogbone arrangement with flexible connection

A device configuration in which a first end and a second end are connected by a flexible portion and arranged in a dogbone shape.

Method of attaching device to skin at axilla

Removably attaching a first end of a device to the skin of a user and a second end of the device to the skin of the user at a position in at least a portion of the axilla, wherein the device comprises a first end with instruments including a communications module and a second end with an optical sensor connected by a flexible portion and arranged in a dogbone shape, with adhesive only on the bottom surfaces of the ends.

Monitoring multiple physiological parameters

Monitoring two or more physiological parameters of the user, including at least one of 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, wherein at least one parameter is monitored by the optical sensor.

Transmission of user data to remote database

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

The independent claims cover a wearable enclosure with distinct first and second ends and a flexible connector for axilla placement, an optical sensor on the second end, adhesive limited to end bottom surfaces, a dogbone form factor, methods of attaching the device in the axilla, monitoring multiple listed physiological parameters, and transmission of collected user data to a remote database.

Stated Advantages

Provides constant monitoring of hospital patients, reducing workload and human error caused by overworked clinicians.

Allows accurate monitoring while allowing user comfort and ability to move more than traditional sensor devices.

Enables continuous monitoring to determine a baseline and detect deviations that could indicate impending adverse events for early detection and intervention.

Improves workflow by eliminating the need for technicians or nurses to perform frequent spot checks and manual data entry, potentially reducing errors and cross-contamination.

Permits unobtrusive and waterproof wear, enabling use during activities and post-discharge monitoring, thereby supporting rehabilitation and remote care.

Offers a non-invasive approach to monitoring cardiac output through pulse contour analysis from an optical sensor on the chest.

Documented Applications

Monitoring patients in the Hospital Emergency Department to provide continuous triage and reduce patients crashing in the waiting room.

Monitoring patients on general hospital floors to provide continuous vital signs monitoring and reduce intermittent spot-checking.

Monitoring postoperative patients at risk of developing respiratory complications to enable continuous post-surgery monitoring and possible home use post-discharge.

Monitoring postsurgery patients at risk for sepsis to detect indicators of possible sepsis infection during recovery and post-discharge.

Monitoring chronically ill patients to allow greater freedom of movement and participation in rehabilitation while continuously collecting vitals.

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

Monitoring cardiac output through pulse contour analysis as a novel, non-invasive way to monitor cardiac output on the chest.

Monitoring telehealth patients to provide relevant real-time data to clinicians during remote consultations.

Monitoring pilots to detect hypoxia during flight and alert the pilot or monitoring personnel to drop in oxygen.

Monitoring wounded soldiers to provide medics with real-time vitals while awaiting medevac in the field.

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