MOBILE PULSE OXIMETRY AND ECG ELECTRODE TELEMETRY DEVICE, SYSTEM AND METHOD OF USE
20220054026 · 2022-02-24
Inventors
Cpc classification
A61B5/7264
HUMAN NECESSITIES
A61B5/318
HUMAN NECESSITIES
A61B5/0816
HUMAN NECESSITIES
A61B5/02055
HUMAN NECESSITIES
A61B5/002
HUMAN NECESSITIES
A61B5/7214
HUMAN NECESSITIES
A61B2562/0219
HUMAN NECESSITIES
International classification
A61B5/0205
HUMAN NECESSITIES
A61B5/00
HUMAN NECESSITIES
A61B5/08
HUMAN NECESSITIES
A61B5/145
HUMAN NECESSITIES
Abstract
A multiparameter monitor (MPM) for a patient includes a disposable electrode patch (DEP) comprising a plurality of male snap post electrodes, an optics interface and a thermal/respiratory interface to a skin surface of the patient. The MPM also includes an electronics module and wireless transmitter (EMT) in connection with a plurality of female snap receptors and configured to transmit a signal data based on a connection and a disconnection of the plurality of the female snap receptors to the male snap post electrodes. The MPM additionally includes a reflective pulse oximeter (RPO) separated from a skin surface of the patient based on a thickness of the DEP, the RPO in communication with the wireless transmitter. The MPM further includes a mobile photoplethysmogram processor (PPG) in communication with the wireless transmitter and the optics interface and configured to filter a motion artifact in the PPG.
Claims
1. A multiparameter monitor (MPM) for a patient, comprising: a) an electrode patch (DEP) comprising a plurality of snap electrodes, an optics interface and a thermal/respiratory interface to a skin surface of the patient; b) an electronics module and wireless transmitter (EMT) in connection with the plurality of snap electrodes and configured to transmit a signal data based on a connection and a disconnection of the plurality of snap electrodes; c) a reflective pulse oximeter (RPO) separated from a skin surface of the patient based on a thickness of the DEP, the RPO in communication with the wireless transmitter of the EMT; d) a mobile photoplethysmogram processor (PPG) in communication with the wireless transmitter and the optics interface and configured to detect a blood pressure and volume changes in a microvascular bed of tissue adjacent the skin surface; e) a visual display of a correlated timeline data from the EMT, RPO and PPG in relation to a body position indicating multiple irregularities outside normal events that coincide to determine a patient's health; and f) a triaxial accelerometer configured to determine the body position of the patient during various ambulatory events relative to resting events including a prostrate and a supine position and a standing up position in regards to patient pulse blood circulation and respiration.
2. The MPM of claim 1, wherein the PPG is further configured to filter a motion artifact in the PPG based on a distinction between a pulsating arterial blood flow and a moving venous blood flow in the patient.
3. The MPM of claim 1, wherein the wireless transmitter further comprises a Bluetooth Low Energy BLE transceiver and controller with built-in antenna preprogrammed to handle all MPM electromagnetic interactions.
4. The MPM of claim 1, wherein the EMT further comprises a user experience (UX) module including LED/switches/audio/haptic/etc.
5. The MPM of claim 1, wherein the EMT further comprises a machine learning and artificial intelligence module configured for adaptive application of the MPM to various body locations including a head, a chest, an abdomen, a thorax and a plurality of locations on limbs.
6. The MPM of claim 1, further comprising a correlated timeline data of an ECG, SPO2, body temperature, respiration and blood pressure in relation to the body position.
7. The MPM of claim 1, wherein the optics interface further defines an optical window in the DEP for the RPO to measure an oxygen content in the patient's blood perfusion.
8. The MPM of claim 1, wherein the thermal/respiratory interface further defines an area over which to measure a skin temperature and a respiration of the patient via a sensor(s).
9. The MPM of claim 1, wherein the EMT further includes an ECG driver configured to generate, receive and process signals between a male snap post electrode and a female snap receptor.
10. The MPM of claim 1, wherein the RPO further comprises an angled lens configured to vary an angle of incidence of an infrared light thereof onto the patient's skin.
11. (canceled)
12. The MPM of claim 1, wherein the EMT further comprises common statistical waveform collection while resting and while ambulatory.
13. The MPM of claim 1, wherein the EMT further comprises a respiration sensor.
14. The MPM of claim 1, further comprising a multipin connector between the DEP and the EMT and configured to provide a mechanical connection and an electrical connection there between.
15. A method for a multiparameter monitoring (MPM) of a patient, the method comprising: a) disposing an electrode patch (DEP) comprising a plurality of snap electrodes, an optics interface and a thermal interface to a skin surface of the patient; b) connecting an electronics module and wireless transmitter (EMT) with a plurality of snap electrodes and configured to transmit a signal data based on a connection and a disconnection of the plurality of snap electrodes; c) separating a reflective pulse oximeter (RPO) from a skin surface of the patient based on a thickness of the DEP, the RPO in communication with the wireless transmitter of the EMT; d) detecting blood pressure and volume changes in a microvascular bed of tissue adjacent the skin surface via a photoplethysmogram in a processor (PPG) in communication with the wireless transmitter and the optics interface, e) visually displaying a correlated timeline data from the DEP, EMT, RPO and PPG in relation to a body position indicating multiple data irregularities outside normal events that coincide to determine a patient's health; and determining the body position of the patient during various ambulatory events relative to various resting events via a triaxial accelerometer.
16. The method of claim 15, further comprising varying an angle of incidence of an infrared light of the RPO onto the patient's skin surface.
17. The method of claim 15, further comprising varying the separation of the RPO from the skin surface of the patient plus or minus a predetermined offset.
18. (canceled)
19. The MPM of claim 15, further comprising storing common statistical PPG waveforms while ambulatory and while resting into the EMT.
20. The MPM of claim 15, further comprising correlating a timeline data of an ECG, SPO2, body temperature, respiration and blood pressure in relation to the body position.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0015]
[0016]
[0017]
[0018]
[0019]
[0020]
[0021]
[0022]
[0023]
[0024]
[0025]
[0026]
[0027]
[0028]
[0029]
[0030]
[0031]
[0032]
[0033] Throughout the description, similar reference numbers may be used to identify similar elements depicted in multiple embodiments. Although specific embodiments of the invention have been described and illustrated, the invention is not to be limited to the specific forms or arrangements of parts so described and illustrated. The scope of the invention is to be defined by the claims appended hereto and their equivalents.
DETAILED DESCRIPTION
[0034] Reference will now be made to exemplary embodiments illustrated in the drawings and specific language will be used herein to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is thereby intended. Alterations and further modifications of the inventive features illustrated herein and additional applications of the principles of the inventions as illustrated herein, which would occur to one skilled in the relevant art and having possession of this disclosure, are to be considered within the scope of the invention.
[0035] Reflectance pulse oximetry is a less common alternative to transmissive pulse oximetry. This method does not require a thin section of the person's body and is therefore well suited to a universal application such as the feet, forehead, and chest, but it also has some limitations. Vasodilation and pooling of venous blood in the head due to compromised venous return to the heart can cause a combination of arterial and venous pulsations in the forehead region and lead to spurious SpO2 results. Such conditions occur while undergoing anesthesia with endotracheal intubation and mechanical ventilation or in patients in the Trendelenburg position.
[0036] Motion artifact can be a significant limitation to pulse oximetry monitoring resulting in frequent false alarms and loss of data. This is because during motion and low peripheral perfusion, many pulse oximeters cannot distinguish between pulsating arterial blood and moving venous blood, leading to underestimation of oxygen saturation. Early studies of pulse oximetry performance during subject motion made clear the vulnerabilities of conventional pulse oximetry technologies to motion artifact.
[0037] Throughout the present disclosure, the term ‘piecewise’ refers to a transmission of multiplexed and superimposed signal data (also called a piecewise function or a hybrid function) and a transmission which is defined by multiple sub-data, each sub-data applying to a certain time interval of the complete transmission domain (a sub-domain) in analog or digital formats. The term ‘merged,’ ‘composite,’ ‘combined,’ and ‘superimposed’ refer to a number of signals that have been made into a single signal. The component signals thereof may be analog or digital and the piecewise transmission may therefore include a respective time period for the analog and the digital pieces thereof. The term ‘sensor’ refers to disclosed components that may include an electrode patch, an amplifier, a transmitter and any other components associated with the disclosed telemetry device in transmitting, detecting, converting and relaying signals from the human body to electric and electronic systems and devices. Also, as used in the present disclosure, the term ‘single’ refers to a solitary electrode patch and telemetry unit as opposed to prior art including multiple patches and or multiple electrodes or multiple telemetry devices. Additionally, the term ‘multiplexer’ refers to a device that selects one of several analog or digital input signals and forwards the selected input into a single line. A multiplexer of 2 inputs has n select lines, which are used to select which input line to send to the output. The term ‘spooled memory,’ refers to a first in last out memory capable of real time compression and magnitude scaling for efficient transmission. The term ‘electrode patch’ as used in the present disclosure includes an electrical conductor used to make contact with a nonmetallic part of a circuit where a patient is the start of a circuit in accordance with an embodiment of the present disclosure. The patch component is a standard disposable patch with sticky adhesive applied to an underside as is standard in the art of electrode patches. The telemetry device disclosed therefore is not an electrode nor an electrode patch but a novel and unobvious device for the quick and convenient gathering of telemetry information from an ambulatory patient via wireless transmissions over radio waves or ultrasonic waves and any other types of communicable waveforms. The term ‘electrical ground’ refers to a voltage reference over which a signal level is taken or measured and that provides a return for current.
[0038]
[0039]
[0040]
[0041]
[0042]
[0043]
[0044]
[0045]
[0046]
[0047]
[0048]
[0049]
[0050] Embodiments of the Spo2 sensor are engineered to detect the oxygen saturation and blood pressure from the chest area, specifically above the sternum area. PPG is utilized for both sensors.
[0051] Visual correlation of the collected data is utilized on a timeline graph in such a way to determine multiple possible irregularities or outside the normal events. These out of the normal parameters are visualized in the software to show possible indications that coincide with each other to determine a patient's health.
[0052] Embodiments of the disclosure include the Spo2 and blood pressure sensors and sensing from the chest area as well as the correlation data that could indicate a health concern and a pattern or series of abnormal bio-readings that correlate with each other or even rule out a correlation. With the correlation data overall patient health can be more identified quickly and accurately.
ECG-Button System Overview
[0053] The ECG-Button System utilizes six sensors adjacent a sternum area of a chest via a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This can include heart rate, electrocardiography (ECG), respiratory rate, skin temperature, activity and posture (body), SpO2 and Blood pressure. Data are transmitted wirelessly from the ECG-Button Sensor for storage and analysis. The ECG-Button System can include the ability to notify healthcare professionals when physiological data fall outside selected parameters.
[0054] The ECG-Button System is an ECG acquisition, storage, and transmission devices that utilizes disposable adhesive to maintain contact with the patient's skin and a hydrogel to promote electrical connectivity. The Platform has a re-usable sensor/recorder module allowing collection, storage and transfer of physiological data such as electrocardiogram (ECG), temperature, respiratory, SpO2 and blood pressure. The system application allows healthcare professionals to use Software Library algorithm located on the server for aided analysis and review; Users can only view the data on the intended device (such as a mobile phone or computer).
[0055] A user may view the physiological data in real time from the smart phone (or similar devices) while it records the data. The ECG-Button System is comprised of the following sub-systems:
ECG-Button Sensor
[0056] The Sensor includes an Adhesive Patch and a reusable Sensor Module attached to the patch. The Patch is designed as a disposable self-adhesive interface to the body. The Sensor Module performs processing functions related to capture of physiologic data and also performs bidirectional communication with the relay device.
Adhesive Patch
[0057] The ECG-Button Adhesive Patch is a single-use, disposable adhesive patch, which includes two ECG electrodes, temperature measuring device, zinc air battery, and a flexible circuit and data collectors. The proposed and predicate Adhesive Patch were designed and constructed with similar multilayers of material and adhesives. Both patches include a skin adhesive side on its base. Both patches have the two ECG electrodes on the adhesive (skin-contact) side of the patch. The electrodes on both patches are covered with a disc of hydrogel. Both patches are powered by a zinc air battery. The proposed Adhesive Patch is different than the predicate in patch outer perimeter.
[0058] The patch is the only component in the device that comes in contact with skin. The skin-contact materials of the proposed device are identical to those of the predicate.
Sensor Module
[0059] The Sensor Module performs processing functions related to capture of physiologic data and also performs bi-directional communication. The Sensor Module includes the embedded processor, tri-axial accelerometer, and Bluetooth low energy transceiver. The Sensor Module is designed to function only when inserted into the disposable patch cavity. After the insertion, the Sensor Module is sealed within the cavity by the patch liner and does not have direct contact with the user.
[0060] The hardware of the Sensor Module of the disclosed device is identical to that of the primary predicate. The disclosed firmware is included in the Sensor Module.
[0061] The ECG-Button System was developed with an Application Programming Interface intended to allow development of user interface applications enabling healthcare professionals to access collected vital information. A comparison of the indications for use statements for the predicate and the proposed device are provided herein. Under the current indication, the product is configured with deployment of both the Relay Software and the ECG-Button System Server Library. The data flow from Sensor to Relay and continue to be transmitted to the ECG-Button System Server for storage and analysis.
[0062]
[0063]
[0064]
[0065]
[0066] Body position is measured by an accelerometer including the effects of gravity and dynamic acceleration and thus allowing a determination of a patient's body orientation and movements on collected and telemetered data. Blood pressure BP is the pressure of circulating blood against the walls of blood vessels. BP outside a normal range can indicate a health concern. Body temperature is a personal datum regarding the health status of an individual and is characterized by volatility and temporality. The personal nature of this information results from how and where it originates in the body. Body temperature outside a normal range can indicate a health concern.
[0067] The ECG-Button device and software utilizes six sensors to capture, display and correlate ECG, Spo2 (blood oxygen level), body temperature, Respiratory rate, Blood pressure and body position from the sternum area of the chest. These six sensors display the collected data and mark abnormal or out of normal range results in near real time along a timeline, the time line can be minutes, hours, days, months or even years. The disclosed graph displays the sensor data along the time line. The time alignment of abnormal or out of range results can be an indicator of a health concern. Each abnormal or out of normal range indicator or a combination thereof is an indicator of a health concern.
[0068]
[0069]
[0070] Although the operations of the method(s) herein are shown and described in a particular order, the order of the operations of each method may be altered so that certain operations may be performed in an inverse order or so that certain operations may be performed, at least in part, concurrently with other operations. In another embodiment, instructions or sub-operations of distinct operations may be implemented in an intermittent and/or alternating manner.
[0071] While the forgoing examples are illustrative of the principles of the present disclosure in one or more particular applications, it will be apparent to those of ordinary skill in the art that numerous modifications in form, usage and details of implementation can be made without the exercise of inventive faculty, and without departing from the principles and concepts of the invention. Accordingly, it is not intended that the disclosure be limited, except as by the specification and claims set forth herein.