Wearable three-dimensional auricular multi-point bio-signal acquisition, health status monitoring, and bio-stimulation device

Patent metadata

Field	Value
Publication number	US-11883135-B2
Application number	US-202117512672-A
Country	US
Kind code	B2
Filing date	Oct 28, 2021
Priority date	Oct 28, 2021
Publication date	Jan 30, 2024
Grant date	Jan 30, 2024

Abstract

The present invention provides a personalized, three-dimensional printed, human auricle-specific multiple auricular points' bio-signal acquisition, health status monitoring, and bio-stimulation device, including an artificial ear model made of at least one bio-compatible, flexible polymer, a plurality of sensing and stimulating electrodes with at least one sensing end and a signal acquisition/processing end penetrating through a body of the ear mold conformably with a human auricle so that a surface of the ear mold where sensing end of the electrodes is disposed creates an electrode-human skin interface for bio-signal detection and bio-stimulation responsive thereto. Methods of fabricating the device based on 3-D printing, 3D scanning and modelling techniques and using thereof for bio-signal acquisition, analysis, health status monitoring and bio-stimulation are also provided.

First claim

The invention claimed is:

1. A three-dimensional printed, personalized auricular multi- point bio-signal acquisition, heath status monitoring, and bio-stimulation device comprising:
an artificial ear model configured to be complementary morphologically to a wearer's outer ear comprising a plurality of 3D printable materials forming a body prepared according to multiple geometrically pre-marked and pre-sampled point locations by 3D scanning, and one or more sensing and simulating electrodes by 3D printing with a plurality of bio-signal sensing ends that are exposed on a surface of the artificial ear model that is proximal to a surface of the wearer's outer ear where the majority of auricular points of human body is located;
at least a data acquisition unit for independently and simultaneously collecting real-time bio-signals detected by the plurality of sensing and stimulating electrodes from the multiple auricular points of the wearer's outer ear and processed by an automatic 3D contour mapping user interface.

2. The device of claim 1 , further comprising a bio-signal processor so that the real-time bio-signals detected by the one or more sensing and stimulating electrodes are responded to by a corresponding stimulating response signal being sent from the bio-signal processor to the respective electrode or electrodes in order to stimulate respective auricular point(s) on the wearer's outer ear.

3. The device of claim 2 , wherein the bio-signal processor is integral into or external to the body of the artificial ear model.

4. The device of claim 2 , wherein the bio-signal processor communicates with the one or more sensing and stimulating electrodes physically or wirelessly.

5. The device of claim 1 , wherein the bio-signals comprise information of physical and physiological signals of the wearer including electrocardiography, electroencephalography, heart rate, blood pressure, blood oxygen saturation, stimulation, skin impedance, temperature, hydration, and pressure with respect to the auricular geometry and spatial distribution of multiple auricular points corresponding to the sensing ends of the one or more sensing and stimulating electrodes, such that temporospatial signal distribution on the wearer's outer ear is visualized by the automatic 3D contour mapping user interface.

6. The device of claim 1 , further comprising a power supply either internal, external, or both to the body of the artificial ear model.

7. The device of claim 1 , wherein the plurality of 3D printable materials comprises a bio-compatible and flexible polymer, and electrically conductive material for forming a plurality of inner electrode pathways, the one or more sensing and stimulating electrodes, and/or integrating with an electrical control unit disposed at a distal surface of the body of the artificial ear model with respect to the wearer's ear.

8. The device of claim 7 , wherein the bio-compatible and flexible polymer comprises flexible elastomer.

9. The device of claim 7 , wherein the electrically conductive material comprises graphene-enhanced polylactic acid.

10. The device of claim 1 , wherein the one or more sensing and stimulating electrodes is/are configured to communicate with a plurality of interconnections through a plurality of inner electrode pathways.

11. A method for making the device of claim 1 , the method comprising:
providing a reverse auricular mold comprising preparing a three-dimensional artificial ear body by 3D molding to have an ear impression shaping conformably with human auricle, mixing at least one bio-compatible polymer with at least one catalyzer uniformly to obtain a mixture, and filling up the three-dimensional artificial ear body with the mixture until the mixture is solidified in order to form a body of the reverse auricular mold;
scanning a three-dimensional geometry of the human auricle comprising using a structural-light-based three-dimensional scanning to generate a point cloud for subsequent three-dimensional geometrical configuration of the reverse auricular mold;
subjecting the reverse auricular mold simultaneously to a 3D printing device incorporating at least a flexible elastomer and a conductive material so as to generate one or more sensing and stimulating electrodes with a sensing end of each of the one or more electrodes that is exposed at the surface which is proximal to the surface of the wearer's outer ear where the majority of the auricular points is located such that a mechanically stable whilst flexible electrode-human skin interface is formed.

12. The method of claim 11 , further comprising incorporating a bio-signal processor, a signal transceiver and a power supply into the body of the reverse auricular mold to receive and process the bio-signals detected by the one or more sensing and stimulating electrodes and the plurality of interconnections, and transmit the processed bio-signals to an automatic 3D contour mapping user interface either physically or remotely communicated with said device.

13. The method of claim 12 , wherein the bio-signals comprise information of physical and physiological signals of the wearer including electrocardiography, electroencephalography, heart rate, blood pressure, blood oxygen saturation, heat stimulation, skin impedance, temperature, hydration, and pressure with respect to auricular geometry and spatial distribution of auricular points of the wearer's outer ear corresponding to the sensing ends of the plurality of sensing and stimulating electrodes, such that temporospatial signal distribution on the wearer's outer ear is visualized by the automatic 3D contour mapping user interface.

14. The method of claim 11 , further providing a plurality of inner electrode pathways in the three-dimensional artificial ear body which communicates with a plurality of interconnections being disposed on an opposite side of the reverse auricular mold which is distal to a surface of the wearer's outer ear where the majority of auricular points is located.

15. A method for diagnosing and/or monitoring health status of a subject comprising providing the device of claim 1 to the subject by physically or non-physically contacting a surface of a body of said device with a surface of an outer ear of the subject, the surface of the body of said device which is in physical or non-physical contact with the surface of the outer ear of the subject comprising a plurality of sensing ends of multiple sensing and stimulating electrodes and interconnecting with a plurality of interconnections disposed at an opposite side to said surface of the body of the device, said surface of the body of the device forming a mechanically stable whilst flexible electrode-skin interface with the surface of the outer ear of the subject where the majority of auricular points is located in order to receive real-time bio-signals from the surface of the outer ear of the subject and respond to the received bio-signals after being processed and subsequently analyzed by an automatic 3D contour mapping user interface.

16. The method of claim 15 , wherein the bio-signals comprise information of physical and physiological signals of the wearer including electrocardiography, electroencephalography, heart rate, blood pressure, blood oxygen saturation, heat stimulation, skin impedance, temperature, hydration, and pressure with respect to auricular geometry and spatial distribution of auricular points of the subject's outer ear corresponding to the sensing ends of the plurality of sensing and stimulating electrodes, such that temporospatial signal distribution on the subject's outer ear is visualized by the

Assignees

• Univ City Hong Kong

Inventors

• Chan Ho-Yin
• Huang Qing Yun
• Li Wen Jung

Classifications

• A61B5/318

  Heart-related electrical modalities, e.g. electrocardiography [ECG] · CPC title

• A61B5/25

  Bioelectric electrodes therefor · CPC title

• A61B5/369

  Electroencephalography [EEG] · CPC title

• A61B5/02055 Primary

  Simultaneously evaluating both cardiovascular condition and temperature · CPC title

• A61B5/0002

  Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network (endoradiosondes A61B5/07) · CPC title