Systems and methods for vital signs monitoring with ear piece

• US 10,251,603 B2
• Filed: 01/26/2016
• Issued: 04/09/2019
• Est. Priority Date: 01/26/2015
• Status: Active Grant

• Current Assignee: G Medical Innovations Holdings Ltd.
• Original Assignee: G Medical Innovations Holdings Ltd.
• Inventors: Geva, Nir, Geva, Yacov
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Morales, Jon Eric C
• Application Number:
  US15/026,258
• Publication Number:
  US 20170079586A1
• Time in Patent Office: 1,169 Days
• Field of Search: 600300, 600301
• CPC Class Codes: A61B 2562/222 Electrical cables or leads therefor, e.g. coaxial cables or ribbon cables
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0008 Temperature signals
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• CPC Class Codes: A61B 5/0086 using infrared radiation
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/02416 using photoplethysmograph signals, e.g. generated by infrared radiation A61B5/14552 takes precedence
• CPC Class Codes: A61B 5/02438 with portable devices, e.g. worn by the patient
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• 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 5/20 for measuring urological functions restricted to the evaluation of the urinary system A61B5/4375 takes precedence
• 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 5/332 Portable devices specially adapted therefor
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4848 : Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/6815 : Ear
• CPC Class Codes: A61B 5/6816 : Ear lobe
• CPC Class Codes: A61B 5/6843 : Monitoring or controlling sensor contact pressure
• CPC Class Codes: A61B 5/6898 : Portable consumer electronic devices, e.g. music players, telephones, tablet computers
• CPC Class Codes: A61B 5/7221 : Determining signal validity, reliability or quality A61B5/7207 and A61B5/7217 take precedence
• CPC Class Codes: A61N 1/0456 : Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0484 : Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/36021 : for treatment of pain
• CPC Class Codes: A61N 1/36025 : for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/37252 : Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data

Abstract

A vital signs monitoring system, the system including: (a) an ear device including: a curved body adapted to a shape of an ear, an upper end, a lower end, two opposite facing sides, a first side adapted to be proximal a skull and a second side adapted to be proximal an earlobe, the ear device including: (i) a temperature sensor adapted to sense a body temperature from a depression between a lower jawbone and skull; and (b) a control system, including a processor and a memory, configured and operable to control operation of the ear device, to collect signals received from at least one sensor including the temperature sensor, to process the signals to provide medically significant results.

Claims

1. A vital signs monitoring system, the system comprising:

(a) an ear device including;

a curved body adapted to a shape of an ear, an upper end, a lower end, two opposite facing sides, a first side adapted to be proximal a skull and a second side adapted to be proximal an earlobe, said ear device comprising;

(i) a temperature sensor adapted to sense a body temperature from a depression between a lower jawbone and skull;

(b) a control system, comprising a processor and a memory, configured and operable to control operation of said ear device, to collect signals received from at least one sensor including said temperature sensor, to process said signals to provide medically significant results; and

(c) at least one electrode operationally coupled to said ear device, said at least one electrode configured to deliver electrical pulses from a power source in said ear device to a skin patch operationally coupled to said at least one electrode.

2. The system of claim 1, wherein said temperature sensor is an infra red (IR) sensor configured to measure IR radiation at said depression, said IR radiation emitted from a carotid artery.

3. The system of claim 1, wherein said temperature sensor includes a thermistor.

4. The system of claim 3, wherein said thermistor is encased in a casing, insulated, and held in place by a thermally conductive adhesive, said casing having a thermally conductive surface adapted to abut said depression.

5. The system of claim 1, wherein said ear device further comprises:

(ii) a first electrode built into an inner curve of said curved body, said first electrode configured to sense signal from behind said ear; and

(iii) a second electrode distanced from, and in electric communication with, said ear device, wherein said first and said second electrodes are adapted to be positioned so as to create a vector required for acquiring electrocardiographic measurements;

wherein the first electrode and the second electrode differ from the at least one electrode operationally coupled to said ear device.

6. The system of claim 5, wherein said second electrode is operationally coupled to said ear device via one of:

a cable and a wireless communications component.

7. The system of claim 1, wherein said ear device further comprises:

(ii) a blood oxygen sensor configured to receive signals that are processed to receive said medically significant results selected from the group including;

a photoplethysmogram (PPG), a peripheral oxygen saturation (SpO2) measurement, a heart rate, a combination of at least two said results.

8. The system of claim 7, wherein said blood oxygen sensor is selected from the group including:

a transmissive sensor and a reflective sensor.

9. The system of claim 8, wherein said blood oxygen sensor is embedded in said ear device.

10. The system of claim 8, wherein said blood oxygen sensor is operationally coupled to said ear device via a connection selected from the group including:

a wired connection and a wireless connection.

11. The system of claim 8, wherein said ear device further includes an earlobe attachment that is adapted to abut an outer surface of an earlobe of said ear, said earlobe attachment including a photodector to receive light energy from a light source of said blood oxygen sensor during a transmissive pulse oximetry event.

12. The system of claim 1, further comprising:

(c) at least one additional sensor adapted to be in electrical communication with a body part so as to receive electrical signals from said body part, wherein said at least one additional sensor is in electrical communication with said ear device, said electrical communication effected by at least one of a wireless connection and a wired connection.

13. The system of claim 12, wherein said at least one additional sensor is an auxiliary ear device, wherein said auxiliary ear device has a curved body adapted to a shape of an ear and adapted to be worn a second ear on a facing side of a head, distanced from said ear device.

14. The system of claim 12, wherein said at least one additional sensor is selected from the group including:

blood oxygen sensor, a heart rate sensor, a blood pressure sensor, a urine sensor, a urine level sensor, a medication level sensor, a medication inducing sensor and a combination sensor including at least two of said sensors.

15. The system of claim 1, further comprising:

(c) a gateway device including;

a short-distance communication module for communicating with said ear device, a processor, memory, and a long-distance communication module for communicating with an external backend computer.

16. The system of claim 15, wherein said gateway device is embodied in a device selected from the group including:

a handheld device, a portable computing device and a body worn device.

17. The system of claim 15, further comprising:

(d) at least one additional sensor adapted to be in electrical communication with a body part so as to receive electrical signals from said body part, wherein said at least one additional sensor in electrical communication with at least one of said ear device and said gateway device, said electrical communication effected by at least one of a wireless connection and a wired connection.

18. The system of claim 1, wherein said ear device further includes:

an anchor member operationally coupled to said upper end of said ear device and adapted to support said ear device on said ear, said anchor member having a speaker embedded therein and a microphone embedded in said lower end of said ear device.

19. The system of claim 18, wherein said microphone is a wire microphone that extends out of said lower end of said ear device by manually manipulating a slider along a channel, said slider and channel integrated in said ear device.

20. A vital signs monitoring system, the system comprising:

(a) an primary ear device including;

a curved body adapted to a shape of an ear, an upper end, a lower end, two opposite facing sides, a first side adapted to be proximal a skull and a second side adapted to be proximal an earlobe, said ear device comprising at least one sensor;

(b) a secondary ear device adapted to be worn a second ear on a facing side of a head, distanced from said primary ear device, said secondary ear device in electrical communication with said primary ear device, said electrical communication effected by at least one of a wireless connection and a wired connection;

(c) a control system embedded in said primary device comprising a processor and a memory, configured and operable to control operation of said primary and secondary ear devices, to collect signals received from at least one sensor, to process said signals to provide medically significant results; and

(d) at least one electrode operationally coupled to said primary ear device, said at least one electrode configured to deliver electrical pulses from a power source in said primary ear device to a skin patch operationally coupled to said at least one electrode.

21. A vital signs monitoring system, the system comprising:

(a) an ear device including;

a curved body adapted to a shape of an ear, an upper end, a lower end, two opposite facing sides, a first side adapted to be proximal a skull and a second side adapted to be proximal an earlobe, said ear device including at least one vital signs sensor; and

(b) at least one electrode operationally coupled to said ear device, said at least one electrode configured to deliver electrical pulses from a power source in said ear device to a skin patch operationally coupled to said at least one electrode; and

(c) a control system, comprising a processor and a memory, configured and operable to control operation of said ear device, to collect signals received from said at least one vital signs sensor, to process said signals to provide medically significant results and to control delivery of said electrical pulses.

22. A vital signs monitoring system, the system comprising:

(a) an ear device including;

a curved body adapted to a shape of an ear, an upper end, a lower end, two opposite facing sides, a first side adapted to be proximal a skull and a second side adapted to be proximal an earlobe, said ear device including at least one vital signs sensor; and

(b) a control system, comprising a processor and a memory, configured and operable to control operation of said ear device, to collect signals received from said at least one vital signs sensor, to process said signals to provide medically significant results;

and at least one electrode operationally coupled to said ear device, said at least one electrode configured to deliver electrical pulses from a power source in said ear device to a skin patch operationally coupled to said at least one electrode.

23. The system of claim 22, further comprising:

(c) a chest device operationally coupled to a biocompatible adhesive patch adapted to be adhered to skin, said chest device including at least some of;

amplifiers, filters, analog-to-digital converters, a local memory and a local processor with a short range wireless communications component, wherein said chest device is configured to acquire electrical signals via said biocompatible adhesive patch, filter and digitize said signals and send said digitized signals to said ear device to process said signals to provide said medically significant results.