Health monitoring systems and methods

• US 9,782,132 B2
• Filed: 12/09/2014
• Issued: 10/10/2017
• Est. Priority Date: 10/07/2012
• Status: Active Grant

• Current Assignee: RDS
• Original Assignee: Rhythm Diagnostic Systems, Inc.
• Inventors: Golda, George Stefan, Moyer, Daniel Van Zandt, Marriott, Mark P., Eletr, Sam, O'Neil, Bruce
• Primary Examiner(s): Eiseman, Adam J
• Assistant Examiner(s): JIAN, SHIRLEY XUEYING
• Application Number:
  US14/565,412
• Publication Number:
  US 20150148637A1
• Time in Patent Office: 1,036 Days
• CPC Class Codes: A61B 2560/0295 adapted for recording user messages or annotations
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/02125 of pulse wave propagation time
• CPC Class Codes: A61B 5/02141 Details of apparatus construction, e.g. pump units or housings therefor, cuff pressurising systems, arrangements of fluid conduits or circuits A61B5/02233, A61B5/0235 take precedence
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/11 Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb for measuring pulse A61B5/02 ;A61B5/1038 takes precedence; motion detection to correct for motion artifacts in physiological signals A61B5/721
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/259 using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/335 using integrated circuit memory devices
• CPC Class Codes: A61B 5/352 : Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/6828 : Leg
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/72 : Signal processing specially adapted for physiological signals or for diagnostic purposes character recognition, recognising digital ink, document-oriented image-based pattern recognition G06V30/00; recognition or understanding of postal images G06V30/424
• CPC Class Codes: A61B 5/7207 : of noise induced by motion artifacts
• CPC Class Codes: A61B 5/721 : using a separate sensor to detect motion or using motion information derived from signals other than the physiological signal to be measured
• CPC Class Codes: A61B 5/7214 : using signal cancellation, e.g. based on input of two identical physiological sensors spaced apart, or based on two signals derived from the same sensor, for different optical wavelengths
• CPC Class Codes: A61B 5/7275 : Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor

Abstract

Systems, methods and devices for reducing noise in health monitoring including monitoring systems, methods and/or devices receiving a health signal and/or having at least one electrode or sensor for health monitoring.

Claims

1. A device for monitoring a physiological parameter, the device being configured to be adhered to the skin of a subject for the physiological parameter monitoring;

the device comprising;

a substrate;

a conductive sensor connected to the substrate, and

a double-sided composite adhesive structure having;

at least first and second layers;

the first layer having;

at least one conductive adhesive portion, and

at least one non-conductive adhesive portion, the at least one conductive portion being disposed as at least one island within the at least one non-conductive portion and being surrounded thereby;

the second layer being non-conductive and being disposed on the first layer and covering a part of the at least one non-conductive adhesive portion adjacent the at least one conductive adhesive portion and covering some but not all of the at least one conductive adhesive portion;

the double-sided composite adhesive structure being attached to the substrate and the conductive sensor; and

,

the at least one conductive adhesive portion

being disposed in conductive communicative contact and connected with the conductive sensor to substantially remove movement of the sensor relative to the conductive adhesive portion, and

being configured to be securely conductively connected to the skin by being adhered to the skin of the subject to substantially remove movement of the conductive sensor relative to the skin to one or both reduce noise or provide a clean signal and to maintain the sensor substantially fixed relative to the skin and thereby one or both reduces or eliminates possible sensor movement relative to the skin for conductive signal communication from the subject to the conductive sensor.

2. A device according to claim 1 wherein the physiological parameter is acquired by the conductive sensor and includes one or more signals for one or more or all of electrocardiography, photoplethysmography, pulse oximetry, temperature, or subject acceleration.

3. A device according to claim 2 wherein the conductive sensor is an electrode for electrocardiography.

4. A device according to claim 3 wherein the electrode is a proxy driven-right-leg electrode.

5. A device according to claim 1 comprising

a plurality of conductive sensors connected to the substrate,

the composite adhesive structure having a plurality of conductive adhesive portions,

the plurality of conductive adhesive portions being disposed in conductive communicative contact with respective ones of the plurality of conductive sensors, and being adapted to be conductively adhered to the skin of the subject for conductive signal communication from the subject to the conductive sensor.

6. A device according to claim 5 wherein the plurality of conductive sensors include at least one, two or three electrodes for electrocardiography;

whereby when one of which is for electrocardiography, the other one or more of the plurality are for one or more other functionalities.

7. A device according to claim 6 wherein one of the electrodes is a proxy driven-right-leg electrode.

8. A device for monitoring a physiological parameter, the device being configured to be adhered to the skin of a subject for the physiological parameter monitoring;

the device comprising;

a substrate;

a conductive sensor connected to the substrate, and

a hydrogel composite adhesive structure having;

at least one conductive hydrogel adhesive portion, and

at least one continuous sheet of insulative adhesive; and

at least one additional layer of insulative adhesive;

the at least one conductive hydrogel adhesive portion being embedded within and through the continuous sheet of insulative adhesive as at least one island within and providing a conductive communicative path through the continuous sheet of insulative adhesive and being surrounded thereby and being attached to the substrate and the conductive sensor;

the composite adhesive structure being configured so that the at least one conductive hydrogel adhesive portion

is disposed in conductive communicative contact and connected with the conductive sensor to substantially remove movement of the sensor relative to the conductive adhesive portion, and

is configured to be securely conductively connected to the skin by being adhered to the skin of the subject to substantially remove movement of the conductive sensor relative to the skin to one or both reduce noise or provide a clean signal and to maintain the sensor substantially fixed relative to the skin and thereby one or both reduces or eliminates possible sensor movement relative to the skin for conductive signal communication therethrough from the subject to the conductive sensor;

the at least one additional layer of insulative adhesive being disposed on the continuous sheet of insulative adhesive and covering a part of the sheet of insulative adhesive adjacent the at least one conductive hydrogel portion and covering some but not all of the at least one conductive hydrogel adhesive portion.

9. A device according to claim 8 wherein the conductive hydrogel adhesive portion of the composite adhesive structure is embedded within multiple layers.

10. A device according to claim 9 wherein the connection of the conductive hydrogel adhesive portion is a central layer, and a hydrocolloid is one of the other layers.

11. A device according to claim 10 wherein the hydrogel portion is an inner Layer 4 and wherein the continuous sheet of insulative adhesive is a Layer 2 and the hydrocolloid is a Layer 1, and the Layer 2 is disposed between Layer 1 on one side, and Layer 4 on the other side.

12. A device according to claim 11 wherein one or both:

an additional Layer 3 is an electrically-isolating and double-sided adhesive and is interdisposed between Layers 2 and 4; and

,

one or both of additional Layers 5 and 6 are disposed on the opposite side of Layer 4 opposite the Layers 1, 2 and 3;

the Layer 5 being an electrically-isolating and double-sided adhesive;

Layer 6 being insulative.

13. A device according to claim 8 wherein the device is structurally configured to be vertically placed on the sternum and which provides reduced motion artifacts for one or more of ECG signals, photoplethysmography waveforms, and oxygen saturation signals.