EXHIBIT 2114
`EXHIBIT 2114
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`EXHIBIT 2114 — PAGE 1
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`ECG Audio Headset and Data Processing Methods
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`FIELD OF THE INVENTION
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`This:invention. relates generally to novel devices and methods for noninvasively
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`qualifying and/or quantifying physiological
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`information from an organism with sensor
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`modules embedded in an audio headset. The invention relates more specifically to novel
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`devices and methods for extracting electrical signals related to physiological information
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`using a headset, novel methods of integrating multiple sensors into a headset, and novel
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`devices and methods for transmitting physiological information from a headset to a wearable
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`electronic device.
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`BACKGROUND OF THE INVENTION
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`Measuring physiological information on moving persons is important for ambulatory
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`monitoring of patients, consumer health and wellness, and similar cases. But there are no
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`technologies for measuring an electrocardiogram (ECG) from a person with an earpiece.
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`This would be a useful technology because persons wear headsets to listen to music while
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`exercising, and they could be monitoring heart rate and other heart rate features at the same
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`time. Additionally, electroencephalogram (EEG), electrooculography (EOG), and other
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`forms of physiological electrical activity would be useful to measure during physical activity.
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`Measuring an ECG via the ears leverages the bilateral symmetry of the human body.
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`Namely, a potential can be measured across the left and right side of the body during the
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`electrical generation of a systolic heart event.
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`For this reason, a net potential may be
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`measured from ear-to-ear during the generation of a heartbeat.
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`Transmitting information from embedded sensors in a headset
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`to a wearable
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`electronic device, such as a mobile phone or digital media player, would introduce
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`difficulties. Namely, there are ofien no ports available for accessing the embedded computer
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`in these wearable devices. Thus, a new method of communicating physiological information
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`from an external device (such as a headset) to a wearable electronic device is needed.
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`SUMMARY OF THE INVENTION
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`The present inVention addresses the aforementioned problems by providing a device
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`that can measure the ECG and other physiological properties of an organism in the form-
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`factor of a headset. More specifically, this invention relates to integrating ECG electrodes,
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`other physiological sensors, and associated electronics into various locations of a headset and
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`the earbud of a headset, as well as integrating this circuitry with a standard audio headset for
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`use with a portable, wearable electronic device.
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`BRIEF DESCRIPTION OF THE DRAWINGS
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`Figure 1 illustrates the invention worn on a human.
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`Figure 2 illustrates the invention connected to a wearable electronic device worn on the arm.
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`Figure 3 illustrates a circuit for extracting an ECG signal from the ear.
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`Figure 4 illustrates the anatOmy of the human ear for extracting an ECG signal.
`Figure 5 illustrates an exemplary ECG earbud near the human ear.
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`Figure 6 illustrates an exemplary ECG stereo headset with embedded electrodes.
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`Figure 7 illustrates an exemplary ECG headset with a pinna cover.
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`Figure 8 illustrates an exemplary flexible ECG sensor module.
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`Figure 9 illustrates an exemplary modular design for an ECG audio headset.
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`Figure 10 illustrates a more specific modular design for an ECG audio headset.
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`DETAILED DESCRIPTION OF THE INVENTION
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`In the following description, reference is made to the accompanying drawings, which
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`form ‘aipart hereof, and which show, by way of illustration, specific embodiments or
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`processes in which the invention may be practiced. Where possible, the same reference
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`numbers are. used throughout the drawings to refer to the same or like components.
`In some
`instances,_xnumerous
`specific details are set
`forth in order
`to provide a thorough
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`understanding of the present invention. The present invention, however, may be practiced
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`Without the specific details or with certain alternative equivalent devices and methods to
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`those-described herein: ":ih'.bther,in§t5n'ces-, weIIanown methods andjidevicesihave not been
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`described in detail so as not to unnecessarily obscure aspects ‘of the present invention.
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`Figure 1
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`illustrates a novel non-limiting invention for monitoring the physiological
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`properties of an organism. More specifically, the invention is a headset which integrates
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`electrodes and/or sensors for monitoring electrocardiograms (EEGs), electroencephalograrns
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`(EEGs), and other physiological properties of an organism. The headset can be designed to
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`function as both an audio headset and a physiological monitor while maintaining essentially
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`the same form-factor of an audio headset.
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`As shown in Figure l, the headset may connect via a wire to a wearable electronic
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`device, though wireless designs are also possible. The wearable electronic device can come
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`from a list of several wearable devices, with nonlimiting examples including: a cellular
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`phone, a smartphone, a digital media player, walkman, a personal digital assistant (PDA), a
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`watch, electronic armband, or the like. An important function of the wearable electronic
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`device is that it can display, audibly, visually, or both, raw or processed information received
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`by the headset. This means that the wearable electronic device may be an embedded system
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`or embedded computer. Figure 2 shows an example of the wearable electronic device worn
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`on the arm, affixed to an arm support, such as an armband.
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`Figure 3 shows an exemplary, nonlimiting electronic circuit for extracting ECG
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`signals from the ear region and generating an output.
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`In this case, multiple gain stages are
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`used to generate a bandpass filter centered in the prime region of an ECG response.
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`Typically, this region will range from 40Hz to 200 Hz.
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`Figure 4 shows a summary of the anatomy of the human ear, where there are several
`locations suitable for contact with ECG electrodes. Optimal places include regions where
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`there is a reasonably conductive skin area, such as a region with sweat pores. Nonlimiting
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`skin contact locations for ECG electrodes include: the ear canal, the meatus, the pinna, the
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`scapha, the helix, the tragus, the earlobe, and the periphery surrounding the region where the
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`ear meets the head.
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`The ECG electrodes may be composed of any conductive material or materials that
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`are solid or gel-like, including, but not limited to: metals, conductive polymers, conductive
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`gels or sol-gels, alloys, conductive plastics/rubbers, semimetals or semiconductors, and the
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`like. Silver/silver chloride electrodes, carbon rubber, copper, and gold electrodes are just a
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`few good examples of electrode materials. The electrodes need not be passive electrodes.
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`In
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`fact, active electrodes can be employed for impedance matching, impedance reduction, and
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`noise reduction. Active electrodes may employ operational amplifiers, voltage followers,
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`impedance-cancelling circuits, or the like.
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`The ECG electrodes can be located along any part of the headset touching the skin.
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`Preferably, the electrodes are located in a headset region that is always in contact with the
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`skin during use. Compression fixtures can be used to press the electrodes more closely
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`against the skin, and gels, conductive gels, liquids, lubricants, or the like can be applied to
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`the electrodes to improve the signal-to-noise ratio of electrocardiograms measured. Multiple
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`electrodes can be embedded in each earbud fixture of a headset, for both mono- and stereo
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`headsets. Additionally, electrodes can be embedded in bracing fixtures, such as ear clips,
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`head supports, and the like.
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`In such case, the bracing fixtures may also help compress the
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`electrodes against the skin to maintain electrode contact.
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`In some embodiments, additional electrodes may be integrated with the headset
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`electrodes for a more complete heart monitoring platform.
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`For example, at
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`least one
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`electrode near the leg or ankle may serve as a good ground reference.
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`In another
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`embodiment, at least one electrode may be integrated within the wearable electronic device,
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`as this device may be worn in such as way that it is always in contact with human skin (see
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`Figure 2).
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`In other embodiments, chest electrodes may be integrated within the circuit for
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`assessed multiple chambers and functions of the heart.
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`In each case, the “hub” for collecting,
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`powering, and/or processing this data may be within the headset itself or the wearable
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`electronic device. For example, all electrodes may complete a circuit within the wearable
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`electronic device or headset.
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`Figure 5 shows an example of how ECG electrodes might be embedded into the
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`earbud of an audio headset.
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`In this case, the electrode material is located on the outer
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`periphery of an earbud, such that the ECG electrodes are in direct contact with the skin of the
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`mid-to-inner ear region, and such that an open region exists for the transmission of sound.
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`Though only one electrode is shown in Figure 5,
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`it should be understood that multiple
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`electrodes of various shapes and orientations can be located on a single earbud.,
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`Figure 6 shows an example of how ECG electrodes may be embedded into a stereo
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`headset.
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`In this case, electrodes are shown embedded in the earbud, the ear fixture, and a
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`back-of-head fixture. Having more than 2 electrodes provides a method of extracting cleaner
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`ECG signals from noise.
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`Figure 7 shows an example of how ECG electrodes may be embedded into a pinna
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`cover of a headset or the back (skin-facing) side of an ear fixture (ear clip). Though this
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`particular figure shows the invention in the form of a wireless (Bluetooth) headset,
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`the
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`invention is equally relevant for wired headsets.
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`In many cases, the electrodes may be integrated into flexible modules for a snugger,
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`more comfortable, and/or more reliable electrode. Figure 8 shows an example of a flexible
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`circuit board according to embodiments of the present invention that can be made out of
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`virtually any stable flexible material, such as kapton, polymers, flexible ceramics, flexible
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`glasses, rubber, and the like. A key requirement of the flexible material of the flexible circuit
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`board is that it must be sufficiently electrically insulating and/or electrochemically inert in
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`comparison to the ECG electrode. As with a standard rigid circuit board, a variety of sensors
`can be mounted on the flexible circuit board, and this board can be integrated into any part of
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`the headset. Flexible circuitry can be especially useful for odd—shaped components of the
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`earpiece. In some cases, flexible piezoelectric polymers, such as polyvinylidene fluoride may
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`be useful for measuring body motion, arterial motion, and auscultatory sounds from the body.
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`One embodiment of the invention takes the form of a module, preferably an earbud .
`module, as shown in Figure 9. In this configuration electronic components are grouped into a
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`common physical
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`location to form a module. One specific, nonlimiting configuration
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`includes the headset speaker(s), headset microphone(s), sensor(s), preamp(s), and the
`microcontroller/modulator integrated into a common module.
`The sensors can be any
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`physiological are environmental sensors capable of fitting into the form-factor of an earbud
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`or headset. This configuration has 2 key advantages. First, it allows-the ECG electrodes and
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`additional sensors to be sampled through the 4-wire audio input/output port of a wearable
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`electronic device. Second, it allows multiple sensors to be integrated into the same earbud
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`module with minimal hardware reconfiguration.
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`In some wearable devices, additional
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`input/output ports are not accessible for external hardware not developed by the original
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`manufacturer. In such case, it is desirable to exploit the analog audio input/output port of the
`wearable electronic device without disturbing the audio performance of the headset for both
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`audio input (to a headset speaker) and audio output (from a headset microphone). The
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`schematic of Figure 9 shows how the invention would pass audio information from the
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`wearable electronic device to the headset speaker, transmit audio information from a headset
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`microphone to the wearable electronic device, and at the same time sample, modulate, and
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`transmit sensor data, such as ECG electrode data. In such case, the sensor data may be
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`modulated by the microcontroller/modulator in such a way that it does not interfere with the
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`audio signal and/or in such a way that
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`it can be easily demodulated by the wearable
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`electronic device. Modulation of the ECG signal can be achieved through an analog
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`modulation technique and/or a digital modulation technique, including, but not limited to
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`amplitude modulation,
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`frequency modulation, phase modulation, phase-shift keying,
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`frequency-shift keying, amplitude-shift keying, quadrature amplitude modulation, continuous
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`phase modulation, wavelet modulation,
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`trellis coded modulation, orthogonal
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`frequency
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`division multiplexing, or the like.
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`In the embodiment presented in Figure 9, the microcontroller may digitize both the
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`audio and sensor signals for digital modulation.
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`In another embodiment,
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`this digitally
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`modulated signal may then be converted to an analog modulated signal, preferably an audio
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`In this case, an analog signal, as
`modulated signal, via the microcontroller using a DAC.
`opposed to a digital signal, Would pass through the audio input of the wearable electronic
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`device. In other embodiments, the microcontroller may digitize sensor information into a
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`buffer in memory, convert the buffered digital information to an analog signal (via a DAC),
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`and send the analog signal .to a modulator for combining the analog microphone audio signal
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`with the analog sensor signal. Converting digital signals back to analog signals may be
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`beneficial because the audio input of the wearable electronic device~ may not be suited for
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`digital information. Other embodiments are also possible.
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`The modulator itself may be part of the microcontroller, a separate chip, or a separate
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`circuit. Other configurations are also possible. A variety of modulator chips, circuits, and the
`like are available in the marketplace today.
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`In some cases, the module of Figure 9 may require power conditioning, because the
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`audio input port of the mobile device may not supply the right level of voltage and/or current.
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`In such case, a power conditioning chip and/or circuit can be implemented to raise or lower
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`the voltage. As a particular example, a voltage multiplier chip may be used to increase the
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`voltage from the audio input.
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`In some cases, the microcontroller itself may have onboard
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`power conditioning such that additional circuitry is not required.
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`Though Figure 9 shows the invention wired to a wearable electronic device, it should
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`be understood that wireless versions can also be implemented in the spirit of this invention.
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`Namely,
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`the audio input and output
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`lines to and from the module (the module being
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`represented by the dotted box in Figure 9) can be connected to a wireless chip, for generating
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`a wireless signal to be received by a wireless receiver in the wearable electronic device.
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`Examples of wireless chips include, but are not limited to, Bluetooth chips, ZigBee chips,
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`WiFi chips, and the like. In some cases,
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`the microcontroller itself can be the internal
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`microcontroller of the wireless chip, for a heavily integrated solution. A specific example of
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`this is the Bluecore processor of the Bluecore chip. For even further integration, the entire
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`processing, wireless interface, and modulating electronics can be integrated into an ASIC
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`(application-specific integrated circuit).
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`In some cases, the analog sensor signals (such as the ECG signals) of Figure 9 may
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`pass through the audio port directly, to be processed further via the embedded computer in
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`the wearable electronic device. In such case, the sensor signal may be processed mostly or
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`entirely by the wearable electronic device.
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`The output of sensor can be passed to wearable electronic device through a wired or
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`wireless configuration. For example, in the wireless configuration, the amplified output from
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`an ECG electrode (Figure 3) can be passed to a wireless processing module, where the
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`wireless processing module can be embedded in the headset, as with a Bluetooth headset. To
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`communicate with the wireless headset,
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`the wearable electronic device, or associated
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`modules attached to the wearable electronic device, must be capable of receiving and
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`processing the wireless signal from the wireless headset. Suitable wireless protocols include,
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`but are not limited to, Bluetooth, ZigBee, WiFi, radio, and several others.
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`In the wired
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`version,
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`the amplified output from the ECG electrode can be processed in a module
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`embedded in the headset, where the resulting signal is passed through one or more wires to
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`the wearable electronic device.
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`It should be understood that some embodiments of the invention may not operate in
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`wireless configuration. For example,
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`information from a single ECG electrode may be
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`pointless without a ground reference. Stated another way, at least 2 electrodes are required to
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`obtain useful information from an ECG, and this may require a complete circuit. For this
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`reason, wireless information from a single electrode may not have useful informational value.
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`In some cases,
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`the wearable electronic device may contain one or more port(s),
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`capable of wired or wireless contact with the headset. These ports must be suitable for
`reCeiving analog or digitized data from the ECG headset and/or transmitting analog or
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`digitized signals from the wearable electronic device to the headset. Examples of such ports
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`include, but or not limited to, Bluetooth dongles, ZigBee dongles, USB, UART, RS232,
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`firewire, optical, or other port. In some embodiments, the ports may be connected directly to
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`separate modules that connect in a wired or wireless fashion with the headset. These
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`modules may be necessary for conditioning the signals or power levels received by or
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`transmitted to the headset. A Bluetooth, ZigBee,
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`level translator, mating connector, or
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`DTMF dongle is one example of such a module. These modules may contain signal
`processing circuitry or components to condition the signals.
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`As shown in Figure 9, the signals entering the wearable electronic device, sent from
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`the headset, may be composed of modulated audio + sensor information. The wearable
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`eleCtronic device, serving as an embedded computer, can digitize, demodulate, process, and
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`manipulate this signal internally. The end result is a pure (or mostly pure) audio signal and a
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`separate sensor signal. Through the GUI of the wearable device, processed sensor
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`information can be displayed visually and/or audibly to the user in a colorful and engaging
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`display. The end result is real-time active health and fitness feedback for the headset wearer,
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`while they enjoy audio at the same time.
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`In some cases, the feedback may be related through
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`the audio headset itself. ECG, core body temperature, physical activity, pulse rate, breathing
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`rate, and other physiological information can be processed by the embedded computer into
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`meaningful assessments such as calories burned, VOzmax, cardiovascular health, and the
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`like.
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`In one embodiment of the invention, additional sensors are embedded into the headset
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`for monitoring additional physiological information and/or environmental exposures of the
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`headset wearer. In such case, an onboard microcontroller (Figure 9) can be used to coordinate
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`the collection, modulation, and transmission of various sensor
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`information.
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`directional arrow in Figure 9 between the microcontroller and the sensors is meant to imply
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`bidirectional communication may be employed.) In a specific embodiment, the sensors are
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`connected in a serial bus, such as an 12C bus,'for poling each sensor and synchronizing the
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`output signal to the wearable electronic device. This 12C approach is employed in Valencell’s
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`Healthset® product.
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`The ECG electrodes, as well as additional sensors, can be embedded into a stande
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`audio headset through a variety of processes, including, but not limited to: molding, screen
`printing, prefabrication, embedded design, encapsulation, or the like.
`In the specific case of
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`molding, a plastic mold may be generated to fit the desired electrode geometry. As the
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`electrode may be integrated into an electronic module, the mold may be designed to fit the
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`entire module. As shown in Figure 9, the module may include all electronic components,
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`including the audio speaker or audio microphone. Screen printing conductive electrodes can
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`be useful
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`for printing over existing, prefabricated headsets.
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`In some cases,
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`the metal
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`enclosures from the headsets or headset speakers themselves can serve as the ECG electrode.
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`In the case of wired headsets, additional wires may be added to connect with ports in the
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`wearable electronic device.
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`The ECG electrodes described herein can also be used to measure the EEG and/or
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`EOG of a person wearing the headset. Extracting EEG and EOG signals in the midst of ECG
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`signals can be achieved using several methods. One method is to place the electrodes in
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`locations closest to a region of interest. For example, integrating EOG sensors in a headset
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`fixture close to the eyes would improve the response to the EOG. Another method is to
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`integrate multiple electrodes at various regions on a single earpiece. As a specific example,
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`having 2 separate electrodes in each earpiece of a stereo headset would provide a way of
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`differentiating EOG, EEG, and ECG signals. This is because the localized potential between
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`the two closely space electrodes in a single earbud can be more indicative of localized ECG
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`and EEG events, whereas the more distal potential between electrodes in separate earbuds
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`can be more indicative the ECG response.
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`Earjewelry, such as piercing or clip-on jewelry, can also be used to help measure the
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`ECG from a wearer. In such case, the electrode wires can be attached to at least one piercing
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`(such as an earring) on each ear of a user, such that the piercing serves as an ECG electrode.
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`Earrings and similar structures may be particularly effective at measuring the ECG because
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`they may be highly fixed, localized, and in intimate contact with the skin.
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`In addition to ECG electrodes,
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`there are several spots available in an earbud for
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`additional physiological and/or environmental sensors. Several of Valencell’s filed US.
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`patents list a variety of sensors that can be integrated into an earbud, as well as how these
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`sensors can be fabricated and integrated into audio headsets. Two of these filed US. patents
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`include:
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`“Telemetric Apparatus
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`for Health
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`and Environmental Monitoring”
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`and
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`“Physiological and Environmental Monitoring Systems and Methods.”
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`w 1
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`. A headset containing electrodes for monitoring at least one electrocardiogram and/or
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`at least one neurological process of an organism, wherein the electrodes are at least
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`partial physical contact with the organism.
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`2. Claim 1 wherein the headset electrodes are part of a circuit.
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`3. Claim 2 wherein the circuit includes at least one other electrode located at another
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`region of the body, wherein the electrodes are at least in partial contact with the
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`organism.
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`4. Claim 3 wherein at least one electrode is location includes the arm, torso, head, hand,
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`leg, foot, and/or other part of the body.
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`5. Claim 2 wherein the circuit contains at
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`least one amplifier for amplifying the
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`electrical signal between at least two electrodes.
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`6. Claim 1 wherein the headset contains at least one additional physiological sensor
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`and/or environmental sensor.
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`7. Claim 1 wherein at least one physiological sensor measures cardiovascular properties
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`other than ECG.
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`8. Claim 7 wherein at least one physiological sensor comes from a list including sensors
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`for: photoplethysmography, core body temperature, pulse oximetry, auscultatory
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`analysis, mechanical arterial pressure, or the like.
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`9. Claim 3 wherein at least one electrode serves as a ground electrode.
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`10. Claim 3 wherein the circuit is configured to make contact with at least one wearable
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`device, wherein the wearable device comes from a list including: portable digital
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`assistants, digital media players, cellular phones, smartphones, mobile computers,
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`20
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`25
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`30
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`digital storage devices, watches, or the like.
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`10
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`11. Claim 10 wherein the wearable device is configured to relate user feedback regarding
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`at least one physiological property.
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`12. Claim 11 wherein the feedback is audio, visual, mechanical, or a combination of
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`these.
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`5
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`13. Claim 1 wherein at least one neurological process includes an EEG.
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`14. Claim 1 wherein the headset includes at least one sensor for measuring core body
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`temperature.
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`15. Claim 1 wherein the headset includes at least one sensor for measuring hydration.
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`16. Claim 1 wherein the headset includes at least one sensor for monitoring footsteps.
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`10
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`17. A method of introducing physiological and/or environmental
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`information from
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`external sensors into a wearable electronic device, wherein the information is
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`processed externally to pass through the audio input of the wearable electronic
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`device, and wherein the capability of transmitting audio information is maintained.
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`18. An earring that serves as an ECG, ECG, or EEG electrode.
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`15 Conclusion
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`While feertain’ . preferred». embodiments, have? been deseribedu 'and shown in: the
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`accompanying d'rawings,‘§it is to be understoOd‘that' such embodiments are merely illustrative
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`of, and not‘prestrictfiive on,fthe broad invention. Furtherrnore,“while certain: innovative-claims
`have-beenhighlighted' in this provisional patent'document, it isi‘to be understoodithat other
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`20 mnovanons notiémphésizedgin theglist orhi‘ghlightediclaims-are.describedinathe text..of,.thié
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`document and 'thusserve as innovative claims.
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`Drawings —- ECG Audio Headset and Data Processing
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`Methods
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`
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`physiological sensors
`+
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`audio headset
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`Fig. 1
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`wearable electronic device
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`
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`mounting fixl ure
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`Fig. 2(.
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`R4
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` Electrode+
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`_ LTC6244
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`— LT06244
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`C1
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`Electrode
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`}
`> Output
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`
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`Preamp stage
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`High Pass filter
`I Gain stage
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`Low Pass filter
`I Gain stage
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`Fig, 3
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`Anatomy of the Ear
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`Pinna
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`
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`Eaflob
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`
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`Tlimpa’nic
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`Membrane / :
`Carotid Artery
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`Hg. 4
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`headset earbud
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`
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`
`.
`output to mred or
`wireless module
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`embedded
`electrode
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` embedded
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`electrodes
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`Pig. 6
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`pinna cover
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`
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`.1 / ear fixture (fear clip)
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` ~
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`F1g. 7
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`sensors and/or electrodes
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` W
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`flexible module or circuit
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`Fig.8
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`I, Headset
`5
`speaker
`E
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`Headset
`microphone
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`& preamps
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`
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`Power/poling/
`control/sampling
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`Microcontroller/
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`Modulator
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`E
`?
`Module
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`
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`Wearable electronsc devrce
`(preferrabl
`equi oed with visual disola )
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`
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`A/ D
`Converter
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`
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`Signal Processor/
`Memory
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`
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`Output Device(s)
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`Fig. 10
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