Health monitoring systems and methods

• US 10,080,527 B2
• Filed: 12/09/2014
• Issued: 09/25/2018
• Est. Priority Date: 10/07/2012
• Status: Active Grant

• Current Assignee: RDS SAS
• 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): Thomson, William
• Assistant Examiner(s): JIAN, SHIRLEY XUEYING
• Application Number:
  US14/565,414
• Publication Number:
  US 20150094552A1
• Time in Patent Office: 1,386 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 one or more physiological parameters, the one or more physiological parameters including blood oxygenation, the device being adapted 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;

a plurality of pulse oximetry sensors connected to the substrate, and,

a plurality of light sources for one or more wavelengths; and

,

an encapsulant that is configured to encapsulate the sensor, the plurality of pulse oximetry sensors and the plurality of light sources and is in operative contact with the sensor, the plurality of pulse oximetry sensors and the plurality of light sources and is configured for light transmission therethrough and to not allow an interference airgap between the sensor, the plurality of pulse oximetry sensors and the plurality of light sources and the encapsulant, providing no internal reflective surface;

the encapsulant also being configured to be disposed in operative contact with the skin of a subject without any other cover between the skin and the encapsulant; and

,

the encapsulant also being configured to provide at least one radius of curvature of at or between 20 mm and 40 mm.

2. A device according to claim 1 the plurality of pulse oximetry sensors and light sources being configured to provide for interrogation of a wider area of capillary bed in order to reduce local motion artifact effects;

wider area defined by being wider than achievable by a single sensor or a single light source per wavelength.

3. A device for reducing noise in health monitoring including a wearable health monitoring device having at least one sensor for health monitoring;

the wearable health monitoring device having;

a composite adhesive having at least one conductive portion applied adjacent the sensor; and

, including

one or more structural adaptations for the at least one sensor for receiving signals with reduced noise;

the one or more structural adaptations including a convex lens for light transmission therethrough;

the convex lens being an encapsulant that encapsulates the sensor and is in operative contact with the sensor and is configured for light transmission therethrough and to not allow an interference airgap between the sensor and the encapsulant, providing no internal reflective surface;

the encapsulant also being configured to be disposed in operative contact with the skin of a subject without any other cover to be disposed between the skin and the encapsulant; and

,

the encapsulant also being configured to provide at least one radius of curvature of at or between 20 mm and 40 mm.

4. A device according to claim 3 the convex lens being configured to be disposed in operative contact with a wearer'"'"'s skin.

5. A device according to claim 3 the convex lens being configured to be disposed in operative contact with a wearer'"'"'s skin at or adjacent the wearer'"'"'s/user'"'"'s forehead or chest.

6. A device according to claim 3 further comprising one or more LEDs, the convex lens encapsulant being configured to encapsulate the one or more LEDs.

7. A device according to claim 3 the convex lens encapsulant being configured to encapsulate the one or more LEDs and being in operative contact with at least one of the one or more LEDs not allowing an interference airgap between the at least one of the one or more LEDs and the encapsulant.

8. A device according to claim 3 the convex lens being one or more of clear, colorless, silicone and medical grade silicone.

9. A device according to claim 8 the convex lens being made from medical grade silicone that is one or more of clear, colorless, soft, low durometer, tacky gel, or has high-tack adhesives embedded on both sides.

10. A device according to claim 9 the silicone comprising one or both:

conformance of the lens to one or both the electronic sensors and skin, or

exhibition of motion artifact reduction by limiting movement between the skin-lens-sensor interface.

11. A device according to claim 9 the convex lens being configured to be trapped between layers of the composite adhesive strip of a wearable health monitoring device, with a raised portion the size of a rectangular opening in the adhesive strip that allows the convex lens to protrude slightly on the patient side of the adhesive strip.

12. A device according to claim 3 the one or more structural adaptations being used for pulse oximetry.

13. A device according to claim 3 the one or more structural adaptations being disposed for and configured for maintained indented operative contact with the wearer'"'"'s/user'"'"'s skin.

14. A device according to claim 3 being configured for providing for transmission of LED waves therethrough to the wearer'"'"'s skin without interfering transmission thereinto.

15. A device according to claim 14 being configured for providing for reception of reflected transmissions of LED waves therethrough from the wearer'"'"'s skin to the sensor without interfering transmission therethrough.