WO2014055382A1 - Control system and apparatus utilizing signals originating in the periauricular neuromuscular system - Google Patents

Control system and apparatus utilizing signals originating in the periauricular neuromuscular system Download PDF

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Publication number
WO2014055382A1
WO2014055382A1 PCT/US2013/062523 US2013062523W WO2014055382A1 WO 2014055382 A1 WO2014055382 A1 WO 2014055382A1 US 2013062523 W US2013062523 W US 2013062523W WO 2014055382 A1 WO2014055382 A1 WO 2014055382A1
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WO
WIPO (PCT)
Prior art keywords
periauricular
person
muscle
sensor
head
Prior art date
Application number
PCT/US2013/062523
Other languages
French (fr)
Inventor
Sandy L. HECK
Original Assignee
Heck Sandy L
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US13/632,594 external-priority patent/US20130123656A1/en
Application filed by Heck Sandy L filed Critical Heck Sandy L
Publication of WO2014055382A1 publication Critical patent/WO2014055382A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/07Endoradiosondes
    • A61B5/076Permanent implantations
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/24Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25Bioelectric electrodes therefor
    • A61B5/279Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/296Bioelectric electrodes therefor specially adapted for particular uses for electromyography [EMG]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802Sensor mounted on worn items
    • A61B5/6803Head-worn items, e.g. helmets, masks, headphones or goggles
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F3/00Input arrangements for transferring data to be processed into a form capable of being handled by the computer; Output arrangements for transferring data from processing unit to output unit, e.g. interface arrangements
    • G06F3/01Input arrangements or combined input and output arrangements for interaction between user and computer
    • G06F3/011Arrangements for interaction with the human body, e.g. for user immersion in virtual reality
    • G06F3/015Input arrangements based on nervous system activity detection, e.g. brain waves [EEG] detection, electromyograms [EMG] detection, electrodermal response detection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0031Implanted circuitry

Definitions

  • This invention generally relates to a control system for enabling a person to actuate an output device and to a method for sensing, receiving or recording actuating signals especially signals from the vestigial nerves and muscles of the periauricular system,
  • Another more specific object of the invention is to use signals from existing vestigial nerves for controlling an output device without causing harm to the patient due to a loss of the functionality in the nerve that is utilized.
  • Another object of the invention is to provide a control system of the type described that is minimally invasive and yet fully capable of wide ranging control capability without a deleterious effect to the operation of other sensory or motor systems thai may still be uninjured and remain in use by a patient.
  • Another object of the invention is to provide a system of the type described that can be used by able-bodied persons for a variety of purposes in relation to disability, strength enhancement, sensor enhancement, computer or cursor manipulation, gaming devices, including video games, the operation of other kinds of mechanical devices, such as appliances, vehicles, robotic devices and other equipment in a hands-free manner.
  • FIG 1 is a diagrammatic side elevational view of a human patient with the posterior auricular nerve exposed to show the point of attachment of the implanted electrode interface.
  • FIG 1 A is a diagrammatic side view of a human head showing the anatomic locations of the periauricular muscles and the locations for EMG electrode placement,
  • FIG 2 is a block flow diagram showing one preferred form of signal processing circuitry for an implantable or wearable system
  • FSG 2A is a perspective schematic to show how positioning in three dimensions is accomplished by an input device.
  • FIGS. 3 and 4 are front and side views, respectively, showing the entire subcutaneous implant secured to the mastoid bone or nearby tissue and coupled by a wire to an electrode that interfaces the nerve.
  • FIG, 5 is a diagrammatic flow diagram of the circuitry used in FIGS. 3 and 4 to show the implanted electrode-nerve interface
  • FIG. 5 A shows an alternative wearable device thai does not require surgical implantation, wherein surface electrodes are held against the head over the auricularis muscles,
  • FIG 5B depicts the relative locations for electrodes on the headset.
  • FIG 5C is a perspective view of another form of headset.
  • FIGS. 6 and 7 are front and side views respectively to show subcutaneous implants as in FIGS. 3-5 but with the implant itself connected via a longer subcutaneous wire to a second pari of the implant located on the upper part of the chest,
  • FIG 8 is a more detailed diagram showing the arrangement of components as depicted in FfGS. 6 and 7 wherein smaller implants on each side are wired to a single secondary subcutaneous implant on the upper chest wall.
  • FIG SA is a more detailed diagram of the wearable headset with two sensor electrodes arranged bilaterally on each side of the head showing ths arrangement? of the components within the headset.
  • FIG 9 is a diagrammatic perspective view to show how a person can actuate or move a virtual output element in more than one dimension.
  • FIG 10 is similar to FIG 9 but shows how a person can move a cursor toward a particular target
  • FIG 1 1 and 1 1 A show a pair of eyeglasses having skin contacting sensors thereon so that the sensors are adjacent a vestigial auricular nerve or muscle when being worn.
  • FIG 12 shows an elastic headband to which skin contacting sensors are affixed so that they will be adjacent a vestigial auricular nerve or muscle when being worn.
  • the present invention relates to a bilateral biosignal recording and signal transmission system that could be wholly or partially implanted in a human or in the alternative, sensed by a wearable device that is worn on the head of the individual, the output of which can be activated, deactivated or moved toward or to a target or pointed toward a target in from one to three dimensions.
  • the system is comprised of an implanted element in contact with the posterior auricular nerve and/or periauricular muscles to record the action potentials originating in the nerve.
  • such an implant includes sensing electrodes that are in direct contact with the periauricular muscles,, thereby supplementing the electrons urogram (ENG) signals recorded by the electrodes on the nerves with EMG signals from the muscles.
  • ENG electrons urogram
  • the recorded signals are transmitted to a signal processing component that amplify them and convert them into digital signals. Tills digital signal Is then transmitted to any suitable electronic receiver, preferably wireless as radio frequency command signals intended to activate, deactivate e.g. turn on or off, or modulate the activity or function of an intended target.
  • the sensed signals represent a distinct output channel for each distinct periauricular musc!e.
  • the system may be implanted or alternatively has sensors comprising surface electrodes worn bilaterally to take advantage of the natural vestigial ability of the periauricular neuromuscular system to "point" the ears at a target.
  • the term "output device" herein S means a real or virtual on or off switch or actuator adapted to point or move in from one to three dimensions.
  • Another aspect of the present invention is the utilization of a multi-muscle vestigial system that evolved bilaterally during vertebrate evolution to "point" hearing in three dimensions for making it possible to identify the direction from which a0 sound arose.
  • the invention enables a person to control the real or virtual action or movement of an output device in from one to three dimensions through the use of at least one electrical sensor which can either be implanted beneath the skin or placed on the surface of the skin as a part of a headset on either one side or if more than one sensor is used, on both sides of a person's head in electrical communication 5 with a vestigial periauricular nerve or muscle.
  • Each sensor then communicates through a selected channel to transmit information preferably in digital form to an output device designating an action to be taken or the position of a target location for enabling the output device to perform the action or to move toward or to a target location through real or virtual space.
  • At least one and preferably up to four sensors0 are located on each side of the head.
  • the invention also provides a new method for enabling an individual to actuate or control an output device by first placing an electrical sensor on at least one side of the head in electrical communication with a vestigial periauricular nerve or muscle, then using a signal provided by the sensor for transmitting informationS designating an action to be performed or to move the device toward or to the target in real or virtual space.
  • FIG I deplete the location and anatomy of the posterior auricular nerve 10. Also shown is the location 12 where the posterior auricular nerve branches off from the facia! nerve, where the facial nerve exits the cranium, and where the Posterior Auricular Nerve lies relative to the Ear Canal.
  • the external auditory meatus is designated 14.
  • the preferred location for the signal detecting element is circled at 16, Sensing electrodes 16 are surgically implanted bilaterally in electrically conductive relationship to the posterior auricular nerve as shown in FIGS. 1 A, 3, 4, 5, 6 and 7.
  • FIG I A is an anatomical depiction of the periauricular muscles.
  • the preferred locations for surface electrodes placed in electrical contact with the skin are circled.
  • FIGS. 2, 5, 8 and SA show preferred signal flow diagrams
  • FIGS, i, 3, 4, 6 and 7 show different ways of implanting the invention
  • FIGS. 5A nd 5B show ways to wear the invention.
  • Each electrode 11 has a transmission channel so that with one electrode on each side of the head there are two channels, with two electrodes on each side, four channels, and three electrodes on each side, six channel .
  • the location of the nerve may be varied somewhat to suit the circumstances and it may be preferable to implant the electrode on a different nerve or nerve branch, either in place of or in addition to the posterior auricular nerve that also innervates the muscles around the ear and scalp.
  • the exact locations of the periauricular muscles may be different from one individual to the next, and the precise placement of each surface electrode may vary slightly.
  • the posterior auricular nerves which are efferent motor nerves arising in the central nervous system (CNS), are part of the vestigial periauricular neuromuscular system that evolved phy!ogenetically to control the orientation of the ear, in particular the ear pinnae, or ear lobes. These nerves send signals to muscles around the e3 ⁇ 4r and scalp enabling humans and animals to orient their ears towards a sound to better identify and localize noises.
  • posterior auricular nerves and periauricular muscles over other neural signal sources is their superficial anatomic position. While other implantable systems that have been developed can be extremely invasive, such as the brain machine interfaces (B I) that use signals from intracrania!ly implanted recording electrodes, the posterior auricular nerves 10 lie jus a few millimeters beneath the skin behind the ear. These nerves and associated periauricular muscles can be accessed with significantly less morbidity, incisions could be well hidden, and there would be no need to drill through the skull or significantly disrupt the natural anatomy of the body.
  • B I brain machine interfaces
  • the wearable sensors of FIGS. 5A, 5B are held against the side of the head to pick up eiectromyogram (EMG) signals from the superficially located periauricular muscles (including the right and left superior auriculans muscles, posterior auriculans muscles, anterior auricular muscles and occipitalis muscle) as will be described in detail below.
  • EMG eiectromyogram
  • the implanted nerve recording device, processing system and transmitter eliminates the need to maintain externa! equipment on the body and allows more freedom of movement for the individual.
  • the F transmitter 2d (FIG 2) sends the signal using a standard wireless format such as Bluetooth, which is widely compatible with many electronic devices, and could potentially require no extra hardware to make targeted technologies compatible with the implant.
  • the wearable surface EMG sensor is a lightweight system that similarly allows freedom of movement and wireless communication with the target device.
  • the bilateral control system described by this invention serves as a way to toggle and adjust, e.g. movement of an output target device 22 such as a wheelchair, a cursor or an automatic lamb (FIG. 2A) toward a target 32 typically in two dimensional or three dimensional space by applying forces in this case in three dianensions as shown by arrows at 34, 36 and 38 using any suitable power sources such as three electric servomotors 50 s 51 and 53 to cause the right-end 55 of the output device of FIG 2A to mover to or toward the target 32.
  • an output target device 22 such as a wheelchair, a cursor or an automatic lamb (FIG. 2A) toward a target 32 typically in two dimensional or three dimensional space
  • any suitable power sources such as three electric servomotors 50 s 51 and 53 to cause the right-end 55 of the output device of FIG 2A to mover to or toward the target 32.
  • the invention works especially well when performing spatially oriented tasks, because the original purpose of these nerves and muscles was to control the directional orientation of the ears towards a target sound or source in a three dimensional environment.
  • Both the implanted and wearable systems are able to control many types of actions including, but not Habited to, a cursor on a computer screen (I.e. a virtual "mouse"), a ear or motorized wheelchair, video games, computers, stereos, televisions, home appliances and utilities, doors and windows, and other prostheses, by way of example.
  • the potential uses of this invention are not limited to the disabled, but also include many uses that would be valuable to able-bodied individuals who wish to enhance their abilities.
  • Such uses could include, among other things; the ability to control a variety of prosthesis, implants, mobility aids, strength enhancements or sensory enhancements in a hands-free manner; the ability to manipulate a cursor, computer, or video game system in a hands-free manner or in a manner that allows the user to simultaneously supplement the use of their hands i.e. moving the cursor without needing to stop typing; the ability to manipulate equipment, technologies or appliances in a wireless and hands-free manner; the ability to facilitate work in industrial, military, medical, space or other environments where wireless or hands-free control is beneficial; and any other situation where a "third arm" would be valuable.
  • the implanted sensor element 1 1 that is placed in contact with the posterior auricular nerve to record signals Is preferably in the form of a nerve cuff electrode known in the art, such as one of a tripo!ar electrode configuration, but the element can be any type of ENG recording electrode interface including sieve electrodes, multielectrode needle arrays, or other conductive material on or in the nerve/nerve fascicules. Insulation around the nerve at the site of the eleetrode(s) may be included to improve the signal and eliminate interference.
  • Implanted electrodes 11 in addition to or in place of the electrodes contacting the nerves, can be Included to directly contact the muscles and capture the signal after it is amplified by the muscle tissue, Such additional EMG electrodes are preferably in the form of wire or flat disk electrodes.
  • Each implanted or surface electrode has its own channel.
  • the signal processing circu try of each channel for each electrode 11 or wearable surface electrode 43-46 described below preferably includes a pre- amplification process, band-pass filtering process, further amplification, and an analog-to-digital conversion process on each side of the head (FIGS. 3, 5B, 5C, 6, 7 and 8A),
  • Other known signal processing mechanisms can be included to capture, optimize and transmit the signal in a way that maximizes the information contained in the desired signal while minimizing interference from unwanted nerve signals or other nearby structures.
  • the signal processing steps are also preferably designed to minimize the electrical power required to process and transmit the signals.
  • the signal transmitting element of FIGS. 2, 5 or 8 use a transm ssion modality that is generally compatible with current electronics and that has low power requirements.
  • This modality is most preferably compatible with Bluetooth, but can include Wi-Fi or any RF transmission that would reliably carry sufficient information with minimal power requirements.
  • the power source or battery element can be a battery similar to that used in an implantable pacemaker, or most preferably be a smaller rechargeable lithium ion battery that would not require replacement.
  • a rechargeable battery could be recharged with an induction coil or by any other method used to recharge implantable batteries.
  • the signal processing, transmission and power elements can be located in a number of different places, Preferably all elements are implanted when an implanted electrode Is used, but in some versions of this invention the processing and/or transmission and/or power element 15 is worn externally and communicate with the implanted elements) 1 1 via the wires 13 or wireless RF transmission.
  • the signal processing, transmission and/or power elements are contained in the same housing as the signal recording element can be mounted nearby on the mastoid bone or cranium, or could be implanted under the clavicle or in the chest wall in a fashion similar to an implantable pacemaker.
  • Some embodiments also have elements 1 1 , 13 and 15 in all of these places; for example, with the signal recording element placed on the nerve, the signal processing element mounted on the mastoid bone, and with the power and transmitter elements implanted subcutaneously in the chest wall.
  • the implanted elements 1 1 should be sealed in a biocompatible way, preferably with materials such as silicone or titanium, or any other materia! clinically proven to be safe for housing implants.
  • FIGS. 5A and 5B illustrate one preferred form of wearable electrode indicated at headset 23.
  • headset 23 there is a connecting resilient headband 25 that fits over the top of the head and on each side a relatively thin, flat bifurcated housing in a shape of an inverted U having anterior and posterior legs that fit anteriorly and posteriorly of the ear, respectively, and a rearwardly extending posterior projection 27.
  • each of the housings 40 and 42 support four EMG sensors comprising a sensor 44 posiiioned just anteriorly of the earlobe, a sensor 43 positioned just posteriorly to the externa! meatus and behind the earlobe, a sensor
  • the headset 23 can be formed from various materials, it is preferably formed from a non-conductive plastic resin such as Lexan or nylon, as well as other plastic resins that will be apparent to those skilled in the art. It will also be seen that the vertical arms of each bifurcated earpiece 40 and 42 provide a failsafe way of correctly positioning the headset to locate the
  • each of the electrodes 43-46 is connected by electrical conductors first through a preamplifier and bandpass filter as shown in Figure 8A and then to a signal processor in which the signal is passed in succession to an amplifier analog-to-digital converter, signal processor, RF transmitter and battery as shown in Figure 8A to illustrate how each of the four separate signals from the sensors 43-46 on each side of the head is processed,
  • the headset 23 contains the electrodes and ail of the electronics necessary to process, transmit and power the device without requiring that any element be implanted under the skin.
  • the invention as shown in FIG. 5A is then worn in a manner similar to the way ordinary headphones are worn, with a strap 25 over the top of the head that connects to compone ts around both ears and holds them in place.
  • each ear piece 40 and 42 is worn over each ear separately and is connected by a strap (not shown) around the back of the head for being incorporated into a hat or helmet, or alternatively around the ears in any of the other known ways that are commonly used to support headphones.
  • the wearable headset 23 receives bilateral signals, with each side of the device incorporating at least 1 EMG recording or sensing site, but it may incorporate up to 4 EMG recording sites 43, 44, 45 and 46 on each side (8 total inputs).
  • the EMG recording sites in such an embodiment are placed over each of the 4 following muscles of the head as shown in FIG ! A; the anterior auricularis muscle, superior auricularis muscle, posterior auricularis muscle, and occipitalis muscle, Other embodiments of the device could include recording sites over any combination of the 4 above mentioned muscles, from 1-4 sites on each side of the headset 25.
  • the headset places surfaces of EMG electrodes 43 and 45 over two muscles on each side of the head so as to provide a total of four distinct inputs consisting of the right and left superior auricularis muscles and the right and left posterior auricularis muscles.
  • the electrodes 11 sense signals directly from the efferent nerves that control the periauricular muscles or from the periauricular muscles themselves.
  • the headset 23 picks up surface EMG signals on the skin that arise over the periauricular muscles since the surface EMG signals can be detected non-invasively on the surface of the skin.
  • Nerve signals themselves are too small to be picked up from the skin but after being, in effect, amplified in the muscles they can be sensed through the skin by the wearable electrodes 43-46,
  • the implanted sensors have much superior susceptibility to interference than skin surface electrodes and are less obtrusive since they provide a stronger signal and since they are hidden,
  • the wearable sensors are less expensive, more accessible to many users and do not require the trauma or expense associated with surgical implantation.
  • the electronics for signal processing and signal transmission can be incorporated into both earpieces 40 and 42, allowing each to act independently, or, in the preferred method where both sides communicate wirelessly or via wires, a single set of processing, power source and transmission components can be shared by both sides if desired.
  • the shared electronics could be all concentrated on one earpiece, be distributed between the two pieces, or built Into the part of the device that connects the two ear pieces 40 and 42.
  • Possible surface electrodes 43-46 include disposable surface electrodes, cup electrodes, bar electrodes, needle electrodes, pointed electrodes, or any of the types used for EMG measuring,
  • the EMG electrodes are differential surface electrodes built permanently into the device and are of the "dry" type that does not require gel, but other embodiments could require the use of conductive gels or disposable electrode elements.
  • Some embodiments of the wearable headset may include buttons, switches, dials and other mechanisms on the device that will allow the user or the user's caregiver to activate/deactivate the device, adjust the device, or otherwise control it. Some embodiments of the invention allow the user to control the device by way of signals generated by the device itself. Such device control signals can be used directly adjust the device, or could do so by way of a "control panel" the user can access via computer interface.
  • inventions of the invention can include a mechanism for the user to receive direct feedback from the implant or wearable device.
  • This feedback mechanism Is useful In situations when the user needs to know that the battery is running low, the device has just been turned on/off or any other situation where getting immediate feedback from the device will enhance the user's ability to use it.
  • This feedback can be an auditory signal produced near the ear, it can be a vibratory signal produced by an element of the device that ts in contact with bone or some other type of signal perceptible to user.
  • the signal processing circuitry may also incorporate a microprocessor programmed to implement a learning function whereby the responsiveness of the system improves over time.
  • the signals from the headset 23 or implant ! 1 may direct the real or virtual motion of an output device in either a manner that is rule based or in a manner that adapts to the individual user.
  • a cursor 60 is moved across a 2-D space represented by ordi ates "x" and "y” with inputs from the bilateral superior auricularis muscles and bilateral posterior auricularis muscles, with EMG voltages from each muscle representing a force vector, e.g. "d" in the 2-D space.
  • the right-sided muscles are used to form a right sided vector com onent, and the superior muscles are used to form an upwards vector component, with the left and inferior muscles containing vector components in the opposite directions.
  • Such rules would be modified for embodiments of the device that have only one electrode on each side or have greater than two electrodes on each side.
  • FIG 9 shows how in accordance with the invention an individual is able to direct cursor 60 across a 2-D computer screen with a rule based system where the vectors a, b, c and d correlate respectively with the left superior auricu!aris muscle (a), the right superior auricularis muscle (b), the left posterior auricniaris muscle (c), and the right posterior auricu!aris muscle (d).
  • the individual is told to move the cursor 60 in an intuitive manner while the system records the pattern of signals that represent each direction of motion. Sn this way, the system calibrates and adapts to each individual user, allowing for natural differences between individuals and provides a specialized control algorithm that is unique for every user,
  • FIG, 10 illustrates another example of the invention in which the pattern of signals produced in the implanted sensor electrodes i 1 moves a computer cursor 60 in a virtual 2 ⁇ D environment towards an intended target 32 by extracting signal power and signal frequency information from each sensing electrode, information regarding the power of the EMG or ENG signal can be calculated by using a root mean squared (RMS) voltage calculation, a rectified voltage calculation, or by any other means to extract power information from the biosignai.
  • RMS root mean squared
  • Frequency information can be extracted from the biosignai by applying a fast Fourier transform (FFT) to the signal, or by other suitable known means applied to biosignais to characterize their frequencies.
  • FFT fast Fourier transform
  • FIG. 1 1 and 1 ! A there is shown a convenient way of positioning skin contacting sensors in close proximity to the vestigia! auricular nerves/muscles by a user.
  • a device similar to what is used to mount lenses in eyeglasses, is indicated generally by numeral 62 and has a plastic frame 64 with pads 66 for supporting the frame on the bridge of the wearer's nose.
  • the pads 66 are preferably conductive and function as a ground or reference electrode.
  • bows 68, 70 adapted to be supported by the ears of the wearer in the well-known manner. Disposed within the bows is the electronic signal processing circuitry that has been previously described. Mounted on the bows proximate their downward curve that wraps around the ears are one or more EMG electrodes 72,74,76 and 78 of the type previously described so positioned that they will closely overlay the vestigial auricular nerves and muscles, allowing pickup of EMG potentials when the frame 62 is being worn. As mentioned, the frame's bow members 68 and 70 also supports the electronics for performing the signal processing and signal transmission function earlier described in connection with the headset of Figure 5. Printed wiring is preferably employed to connect the ground electrode 66 and the EMG electrodes 72, 74, 76 and 78 to the electronic circuitry residing in the bows 68, 70.
  • pads, as at 80 are positioned to rest on the skin where the external ears join the head.
  • a suitably shaped pad 81 may also be provided at the point where the front portion of the frame engages the forehead.
  • an elastic band or strap 82 may encircle the back of the wearer's head to more firmly compress the electrodes 72, 74, 76, 78 against the skin at the site of the vestigial nerves and muscles for more intimate contact and to more firmly secure the device 62 in place.
  • Figure 12 illustrates a still further approach for positioning surface electrodes in relation to the vestigial auricular nerves and muscles shown in Figure 1 A.
  • an elastic headband 72 is shown being worn by a person so as to encircle the forehead and remainder of the skull at a location above the person's auricles.
  • electronic modules as at 73, 74 having exposed surface electrodes that are held in close contact with the person's skin at locations earlier identified In the discussion herein of Figures I and ⁇ A.
  • the elastic headband of Figure 12 may have integrally formed appendages as at 75 that project down from the head encircling band and which carry electrodes corresponding to 43 and 44 of Figure S A,
  • the appendages may include a plastic leaf spring member for urging the electrodes carried thereby against the skin.
  • one or more straps 76 running over the top of the sknM and affixed at opposed ends to the elastic band may be used for added stability.

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Abstract

This enables user to control real or virtual action or movement of output device in from one to three dimensions through use of at least one electrical sensor which can either be implanted beneath the skin or placed on the surface of the skin as a part of a headset on either one side or if more than one sensor is used on both sides of a person's head in electrical communication with a vestigial periauricular nerve or muscle. Each sensor then communicates through a selected channel to transmit information preferably in digital form to an output device designating an action to be taken or the position of a target location for enabling the output device to perform the action or to move toward or to a target location through real or virtual space. Typically, up to four sensors are located on each side of the head.

Description

!
Coffifrol System d Apparatus
Ijti!mssg Signals Originating is? the Perlaiiricislar Nesiramesralar System
CROSS REFERENCE TO RELATED APPLICATION
This application claims the benefit of U.S. application Serial No, 13/632,594, filed October 1 , 2012, entitled "Control System and Apparatus Utilizing Signals Originating in the Periauricular Neuromuscular System ", which is a continuation-in- part of application Serial No. S 3/295446, filed November 4, 201 1, the contents of which are hereby incorporated by reference, and which application claims priority to provisional application serial no, 61/413,661, filed November 15, 2010, and entitled "Method and Apparatus for an Implantable Microbionlc Control System Using Signals from the Posterior Auricular Nerves and Nerves Innervating the Peri-auricular Muscles".
FIELD OF THE INVENTION
This invention generally relates to a control system for enabling a person to actuate an output device and to a method for sensing, receiving or recording actuating signals especially signals from the vestigial nerves and muscles of the periauricular system,
BACKGROUND AND POTENTIAL APPLICATIONS
There is a critical need for assistive devices to aid individuals who have lost their ability, either through injury or disease, to interact with their environment. Hundreds of thousands of individuals in the US and around the world are living with a debilitating spinal cord injury (SCI), and tens of thousands of new cases are occurring each year. These injuries occur in the prime of life for most individuals, and losing of the ability to interact with one's environment can be devastating. There is also a need for these assistive devices among individuals with traumatic brain injury (TBI), stroke or other trauma that results in quadrip!egia or locked-in syndrome. Additionally, Individuals with diseases such as amyotrophic lateral sclerosis (ALS), multiple sclerosis, Lesch Nyhan Syndrome, Parkinson's Disease, cerebral palsy, and even arthritis, have a need for these types of devices.
Many technologies have been developed and implemented to assist these individuals, including "sip and puff' instruments, eye movement tracking, electroencephalogram (EEG) sensors, tongue pressure sensors, and others. These solutions have inherent l mitations, particularly that they usurp other body systems, cannot be controlled with precision, and require cumbersome external equipment.
While it has been previously proposed e.g. by Joshi ei al U.S. pending application S.N, 12/163919 to sense EMG signals from a muscle on the head, Joshi constructs his device to reduce signal interference in order to utilize Impulses from a single muscle, The present invention, however, has nothing to do with capturing multiple channels of output from a single muscle. Moreover, the way the electrodes are placed for sensing in the present invention is far different from the teachings of Joshi and includes the placement of electrodes bilaterally as well as in multiple positions on each side of the head to capture bilateral signals for utilizing the vestigial ability of the periauricular nervous system to point Irs space.
It is one general object of the present invention to provide individuals with a control system that lets them interact with their environment without the limitations inherent m the currently available technologies.
Another more specific object of the invention is to use signals from existing vestigial nerves for controlling an output device without causing harm to the patient due to a loss of the functionality in the nerve that is utilized.
Another object of the invention is to provide a control system of the type described that is minimally invasive and yet fully capable of wide ranging control capability without a deleterious effect to the operation of other sensory or motor systems thai may still be uninjured and remain in use by a patient.
Another object of the invention is to provide a system of the type described that can be used by able-bodied persons for a variety of purposes in relation to disability, strength enhancement, sensor enhancement, computer or cursor manipulation, gaming devices, including video games, the operation of other kinds of mechanical devices, such as appliances, vehicles, robotic devices and other equipment in a hands-free manner.
It is still another object of the invention to make possible the sensing of signals derived from the vestigial periauricular nerves or muscles without requiring surgery.
These and other more detailed arid specific objects and advantages of the present inventio will be better understood by reference to the following figures and detailed description which illustrate by way of example but a few of the various forms of the invention within the scope of the appended claims.
THE DRAWINGS
FIG 1 is a diagrammatic side elevational view of a human patient with the posterior auricular nerve exposed to show the point of attachment of the implanted electrode interface.
FIG 1 A is a diagrammatic side view of a human head showing the anatomic locations of the periauricular muscles and the locations for EMG electrode placement,
FIG 2 is a block flow diagram showing one preferred form of signal processing circuitry for an implantable or wearable system,
FSG 2A is a perspective schematic to show how positioning in three dimensions is accomplished by an input device.
FIGS. 3 and 4 are front and side views, respectively, showing the entire subcutaneous implant secured to the mastoid bone or nearby tissue and coupled by a wire to an electrode that interfaces the nerve.
FIG, 5 is a diagrammatic flow diagram of the circuitry used in FIGS. 3 and 4 to show the implanted electrode-nerve interface,
FIG. 5 A shows an alternative wearable device thai does not require surgical implantation, wherein surface electrodes are held against the head over the auricularis muscles,
FIG 5B depicts the relative locations for electrodes on the headset.
FIG 5C is a perspective view of another form of headset.
FIGS. 6 and 7 are front and side views respectively to show subcutaneous implants as in FIGS. 3-5 but with the implant itself connected via a longer subcutaneous wire to a second pari of the implant located on the upper part of the chest,
FIG 8 is a more detailed diagram showing the arrangement of components as depicted in FfGS. 6 and 7 wherein smaller implants on each side are wired to a single secondary subcutaneous implant on the upper chest wall.
FIG SA is a more detailed diagram of the wearable headset with two sensor electrodes arranged bilaterally on each side of the head showing ths arrangement? of the components within the headset.
FIG 9 is a diagrammatic perspective view to show how a person can actuate or move a virtual output element in more than one dimension.
FIG 10 is similar to FIG 9 but shows how a person can move a cursor toward a particular target,
FIG 1 1 and 1 1 A show a pair of eyeglasses having skin contacting sensors thereon so that the sensors are adjacent a vestigial auricular nerve or muscle when being worn.
FIG 12 shows an elastic headband to which skin contacting sensors are affixed so that they will be adjacent a vestigial auricular nerve or muscle when being worn.
SUMMARY OF THE INVENTION
The present invention relates to a bilateral biosignal recording and signal transmission system that could be wholly or partially implanted in a human or in the alternative, sensed by a wearable device that is worn on the head of the individual, the output of which can be activated, deactivated or moved toward or to a target or pointed toward a target in from one to three dimensions. In one embodiment, the system is comprised of an implanted element in contact with the posterior auricular nerve and/or periauricular muscles to record the action potentials originating in the nerve. Preferably, such an implant includes sensing electrodes that are in direct contact with the periauricular muscles,, thereby supplementing the electrons urogram (ENG) signals recorded by the electrodes on the nerves with EMG signals from the muscles. The recorded signals are transmitted to a signal processing component that amplify them and convert them into digital signals. Tills digital signal Is then transmitted to any suitable electronic receiver, preferably wireless as radio frequency command signals intended to activate, deactivate e.g. turn on or off, or modulate the activity or function of an intended target. In one preferred embodiment, the sensed signals represent a distinct output channel for each distinct periauricular musc!e. The system may be implanted or alternatively has sensors comprising surface electrodes worn bilaterally to take advantage of the natural vestigial ability of the periauricular neuromuscular system to "point" the ears at a target. The term "output device" herein S means a real or virtual on or off switch or actuator adapted to point or move in from one to three dimensions.
Another aspect of the present invention is the utilization of a multi-muscle vestigial system that evolved bilaterally during vertebrate evolution to "point" hearing in three dimensions for making it possible to identify the direction from which a0 sound arose. In this way, the invention enables a person to control the real or virtual action or movement of an output device in from one to three dimensions through the use of at least one electrical sensor which can either be implanted beneath the skin or placed on the surface of the skin as a part of a headset on either one side or if more than one sensor is used, on both sides of a person's head in electrical communication 5 with a vestigial periauricular nerve or muscle. Each sensor then communicates through a selected channel to transmit information preferably in digital form to an output device designating an action to be taken or the position of a target location for enabling the output device to perform the action or to move toward or to a target location through real or virtual space. At least one and preferably up to four sensors0 are located on each side of the head.
The invention also provides a new method for enabling an individual to actuate or control an output device by first placing an electrical sensor on at least one side of the head in electrical communication with a vestigial periauricular nerve or muscle, then using a signal provided by the sensor for transmitting informationS designating an action to be performed or to move the device toward or to the target in real or virtual space.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The invention will be more clearly understood by referring to the figures given by way of example which show how bilateral signals from the nerves and muscles of0 the periauricular system are captured by electrodes according to my invention. Refer now ίο FIG I which deplete the location and anatomy of the posterior auricular nerve 10. Also shown is the location 12 where the posterior auricular nerve branches off from the facia! nerve, where the facial nerve exits the cranium, and where the Posterior Auricular Nerve lies relative to the Ear Canal. The external auditory meatus is designated 14. The preferred location for the signal detecting element is circled at 16, Sensing electrodes 16 are surgically implanted bilaterally in electrically conductive relationship to the posterior auricular nerve as shown in FIGS. 1 A, 3, 4, 5, 6 and 7.
FIG I A is an anatomical depiction of the periauricular muscles. The preferred locations for surface electrodes placed in electrical contact with the skin are circled. The following discussion will describe the invention with the aid of FIGS. 2, 5, 8 and SA which show preferred signal flow diagrams, FIGS, i, 3, 4, 6 and 7 show different ways of implanting the invention, while FIGS. 5A nd 5B show ways to wear the invention. Each electrode 11 has a transmission channel so that with one electrode on each side of the head there are two channels, with two electrodes on each side, four channels, and three electrodes on each side, six channel . Depending on the individual's anatomy, the location of the nerve may be varied somewhat to suit the circumstances and it may be preferable to implant the electrode on a different nerve or nerve branch, either in place of or in addition to the posterior auricular nerve that also innervates the muscles around the ear and scalp. Similarly, the exact locations of the periauricular muscles may be different from one individual to the next, and the precise placement of each surface electrode may vary slightly.
The posterior auricular nerves, which are efferent motor nerves arising in the central nervous system (CNS), are part of the vestigial periauricular neuromuscular system that evolved phy!ogenetically to control the orientation of the ear, in particular the ear pinnae, or ear lobes. These nerves send signals to muscles around the e¾r and scalp enabling humans and animals to orient their ears towards a sound to better identify and localize noises. This ability remains in many other mammalian s eel sj but it is no longer functionally significant in humans and is therefore considered vestigial Although these muscles are small and serve no functional purpose today, the muscles and the nerves that innervate them, including the posterior auricular nerves, remam and are present in nearly everyone yet are nevertheless vestigial
The bilateral use of these nerves and the rnuseles they innervate according to the present invention as part of a control system presents an opportunity for the disabled. Since these nerves are cranial nerves that ex t directly from the brainstem (rather than from the spinal cord), they can and most often do remain undamaged even In the highest cervical spinal injuries. These periauricular nerves and muscles are also not needed for any other purpose, so the individual is able to use them without impairing or complicating the use of other muscle systems, such as the mouth, tongue, eyes, or any other organs normally usurped for this purpose by current commercially available control systems. Since the periauricular muscles are normally not used it was found in developing the present invention that some training is often required to teach the individual how to selectively use them. Training individuals to use these nerves/ scles is similar to training a person to wiggle their ears or scalp.
Another advantage of the posterior auricular nerves and periauricular muscles over other neural signal sources is their superficial anatomic position. While other implantable systems that have been developed can be extremely invasive, such as the brain machine interfaces (B I) that use signals from intracrania!ly implanted recording electrodes, the posterior auricular nerves 10 lie jus a few millimeters beneath the skin behind the ear. These nerves and associated periauricular muscles can be accessed with significantly less morbidity, incisions could be well hidden, and there would be no need to drill through the skull or significantly disrupt the natural anatomy of the body.
As an alternative to the implantable system, the wearable sensors of FIGS. 5A, 5B( 5C and 8A are held against the side of the head to pick up eiectromyogram (EMG) signals from the superficially located periauricular muscles (including the right and left superior auriculans muscles, posterior auriculans muscles, anterior auricular muscles and occipitalis muscle) as will be described in detail below.
Much of the cumbersome equipment that Is currently required for many other control systems is eliminated by the present invention. Other systems that, for example, use tongue, neck, eye or finger movements require cumbersome externa! equi ment to record and track these movements, Such equipment must usually be mounted on or near the individual. In the invention described here, the implanted nerve recording device, processing system and transmitter eliminates the need to maintain externa! equipment on the body and allows more freedom of movement for the individual The F transmitter 2d (FIG 2) sends the signal using a standard wireless format such as Bluetooth, which is widely compatible with many electronic devices, and could potentially require no extra hardware to make targeted technologies compatible with the implant. The wearable surface EMG sensor is a lightweight system that similarly allows freedom of movement and wireless communication with the target device.
The bilateral control system described by this invention serves as a way to toggle and adjust, e.g. movement of an output target device 22 such as a wheelchair, a cursor or an automatic lamb (FIG. 2A) toward a target 32 typically in two dimensional or three dimensional space by applying forces in this case in three dianensions as shown by arrows at 34, 36 and 38 using any suitable power sources such as three electric servomotors 50s 51 and 53 to cause the right-end 55 of the output device of FIG 2A to mover to or toward the target 32.
The invention works especially well when performing spatially oriented tasks, because the original purpose of these nerves and muscles was to control the directional orientation of the ears towards a target sound or source in a three dimensional environment. Both the implanted and wearable systems are able to control many types of actions including, but not Habited to, a cursor on a computer screen (I.e. a virtual "mouse"), a ear or motorized wheelchair, video games, computers, stereos, televisions, home appliances and utilities, doors and windows, and other prostheses, by way of example.
The potential uses of this invention are not limited to the disabled, but also include many uses that would be valuable to able-bodied individuals who wish to enhance their abilities. Such uses could Include, among other things; the ability to control a variety of prosthesis, implants, mobility aids, strength enhancements or sensory enhancements in a hands-free manner; the ability to manipulate a cursor, computer, or video game system in a hands-free manner or in a manner that allows the user to simultaneously supplement the use of their hands i.e. moving the cursor without needing to stop typing; the ability to manipulate equipment, technologies or appliances in a wireless and hands-free manner; the ability to facilitate work in industrial, military, medical, space or other environments where wireless or hands-free control is beneficial; and any other situation where a "third arm" would be valuable. The implanted sensor element 1 1 that is placed in contact with the posterior auricular nerve to record signals Is preferably in the form of a nerve cuff electrode known in the art, such as one of a tripo!ar electrode configuration, but the element can be any type of ENG recording electrode interface including sieve electrodes, multielectrode needle arrays, or other conductive material on or in the nerve/nerve fascicules. Insulation around the nerve at the site of the eleetrode(s) may be included to improve the signal and eliminate interference. Other implanted electrodes 11 , in addition to or in place of the electrodes contacting the nerves, can be Included to directly contact the muscles and capture the signal after it is amplified by the muscle tissue, Such additional EMG electrodes are preferably in the form of wire or flat disk electrodes.
Each implanted or surface electrode has its own channel. As shown in FSGS. 2, 5 and S, the signal processing circu try of each channel for each electrode 11 or wearable surface electrode 43-46 described below preferably includes a pre- amplification process, band-pass filtering process, further amplification, and an analog-to-digital conversion process on each side of the head (FIGS. 3, 5B, 5C, 6, 7 and 8A), Other known signal processing mechanisms can be included to capture, optimize and transmit the signal in a way that maximizes the information contained in the desired signal while minimizing interference from unwanted nerve signals or other nearby structures. The signal processing steps are also preferably designed to minimize the electrical power required to process and transmit the signals.
The signal transmitting element of FIGS. 2, 5 or 8 use a transm ssion modality that is generally compatible with current electronics and that has low power requirements. This modality is most preferably compatible with Bluetooth, but can include Wi-Fi or any RF transmission that would reliably carry sufficient information with minimal power requirements.
In the implanted embodiment, the power source or battery element can be a battery similar to that used in an implantable pacemaker, or most preferably be a smaller rechargeable lithium ion battery that would not require replacement. A rechargeable battery could be recharged with an induction coil or by any other method used to recharge implantable batteries.
While the implanted signal recording element 1 1 of FIG S is in direct contact with the posterior auricular nerve and/or periauricular muscles, the signal processing, transmission and power elements can be located in a number of different places, Preferably all elements are implanted when an implanted electrode Is used, but in some versions of this invention the processing and/or transmission and/or power element 15 is worn externally and communicate with the implanted elements) 1 1 via the wires 13 or wireless RF transmission. In the first embodiment, in which ail elements 11, 13 and 15 are implanted, the signal processing, transmission and/or power elements are contained in the same housing as the signal recording element can be mounted nearby on the mastoid bone or cranium, or could be implanted under the clavicle or in the chest wall in a fashion similar to an implantable pacemaker. Some embodiments also have elements 1 1 , 13 and 15 in all of these places; for example, with the signal recording element placed on the nerve, the signal processing element mounted on the mastoid bone, and with the power and transmitter elements implanted subcutaneously in the chest wall.
The implanted elements 1 1 should be sealed in a biocompatible way, preferably with materials such as silicone or titanium, or any other materia! clinically proven to be safe for housing implants.
Refer now to Figures 5A and 5B which illustrate one preferred form of wearable electrode indicated at headset 23. It will be seen that there is a connecting resilient headband 25 that fits over the top of the head and on each side a relatively thin, flat bifurcated housing in a shape of an inverted U having anterior and posterior legs that fit anteriorly and posteriorly of the ear, respectively, and a rearwardly extending posterior projection 27. Thus each of the housings 40 and 42 support four EMG sensors comprising a sensor 44 posiiioned just anteriorly of the earlobe, a sensor 43 positioned just posteriorly to the externa! meatus and behind the earlobe, a sensor
45 positioned superior to the first two electrodes and intermediate them on a dorso- ventral line just beneath the top of the ear pinnae or pinnea as well as a fourth sensor
46 at the rear end of the dorsal projection 27. While the headset 23 can be formed from various materials, it is preferably formed from a non-conductive plastic resin such as Lexan or nylon, as well as other plastic resins that will be apparent to those skilled in the art. It will also be seen that the vertical arms of each bifurcated earpiece 40 and 42 provide a failsafe way of correctly positioning the headset to locate the
EMG sensors in place over the respective muscles. The invention thus provides four sensing or recording sites on each side of the head. As Indicated in Figures 1 A, 5 A, 5B and 5C, each of the electrodes 43-46 is connected by electrical conductors first through a preamplifier and bandpass filter as shown in Figure 8A and then to a signal processor in which the signal is passed in succession to an amplifier analog-to-digital converter, signal processor, RF transmitter and battery as shown in Figure 8A to illustrate how each of the four separate signals from the sensors 43-46 on each side of the head is processed,
In the wearable embodiment, the headset 23 contains the electrodes and ail of the electronics necessary to process, transmit and power the device without requiring that any element be implanted under the skin. The invention as shown in FIG. 5A is then worn in a manner similar to the way ordinary headphones are worn, with a strap 25 over the top of the head that connects to compone ts around both ears and holds them in place. In other embodiments, each ear piece 40 and 42 is worn over each ear separately and is connected by a strap (not shown) around the back of the head for being incorporated into a hat or helmet, or alternatively around the ears in any of the other known ways that are commonly used to support headphones.
The wearable headset 23 receives bilateral signals, with each side of the device incorporating at least 1 EMG recording or sensing site, but it may incorporate up to 4 EMG recording sites 43, 44, 45 and 46 on each side (8 total inputs). The EMG recording sites in such an embodiment are placed over each of the 4 following muscles of the head as shown in FIG ! A; the anterior auricularis muscle, superior auricularis muscle, posterior auricularis muscle, and occipitalis muscle, Other embodiments of the device could include recording sites over any combination of the 4 above mentioned muscles, from 1-4 sites on each side of the headset 25.
Referring to Figures 5C and I A it can be seen that the headset places surfaces of EMG electrodes 43 and 45 over two muscles on each side of the head so as to provide a total of four distinct inputs consisting of the right and left superior auricularis muscles and the right and left posterior auricularis muscles.
It will be understood that in the case of the implantable sensors, the electrodes 11 sense signals directly from the efferent nerves that control the periauricular muscles or from the periauricular muscles themselves. In the wearable electrodes 43-46, on the other hand, no surgery is used, Instead, the headset 23 picks up surface EMG signals on the skin that arise over the periauricular muscles since the surface EMG signals can be detected non-invasively on the surface of the skin. Nerve signals themselves, however, are too small to be picked up from the skin but after being, in effect, amplified in the muscles they can be sensed through the skin by the wearable electrodes 43-46, The implanted sensors have much superior susceptibility to interference than skin surface electrodes and are less obtrusive since they provide a stronger signal and since they are hidden, The wearable sensors, however, are less expensive, more accessible to many users and do not require the trauma or expense associated with surgical implantation.
The electronics for signal processing and signal transmission can be incorporated into both earpieces 40 and 42, allowing each to act independently, or, in the preferred method where both sides communicate wirelessly or via wires, a single set of processing, power source and transmission components can be shared by both sides if desired. The shared electronics could be all concentrated on one earpiece, be distributed between the two pieces, or built Into the part of the device that connects the two ear pieces 40 and 42.
Possible surface electrodes 43-46 include disposable surface electrodes, cup electrodes, bar electrodes, needle electrodes, pointed electrodes, or any of the types used for EMG measuring, In the preferred embodiment, the EMG electrodes are differential surface electrodes built permanently into the device and are of the "dry" type that does not require gel, but other embodiments could require the use of conductive gels or disposable electrode elements.
Some embodiments of the wearable headset may include buttons, switches, dials and other mechanisms on the device that will allow the user or the user's caregiver to activate/deactivate the device, adjust the device, or otherwise control it. Some embodiments of the invention allow the user to control the device by way of signals generated by the device itself. Such device control signals can be used directly adjust the device, or could do so by way of a "control panel" the user can access via computer interface.
Other embodiments of the invention can include a mechanism for the user to receive direct feedback from the implant or wearable device. This feedback mechanism Is useful In situations when the user needs to know that the battery is running low, the device has just been turned on/off or any other situation where getting immediate feedback from the device will enhance the user's ability to use it. This feedback can be an auditory signal produced near the ear, it can be a vibratory signal produced by an element of the device that ts in contact with bone or some other type of signal perceptible to user. The signal processing circuitry may also incorporate a microprocessor programmed to implement a learning function whereby the responsiveness of the system improves over time.
The control of the motion and direction of motion of a real or virtual output device will now be described. The signals from the headset 23 or implant ! 1 may direct the real or virtual motion of an output device in either a manner that is rule based or in a manner that adapts to the individual user. In a rule based system, for example in FIG 9, a cursor 60 is moved across a 2-D space represented by ordi ates "x" and "y" with inputs from the bilateral superior auricularis muscles and bilateral posterior auricularis muscles, with EMG voltages from each muscle representing a force vector, e.g. "d" in the 2-D space. The right-sided muscles are used to form a right sided vector com onent, and the superior muscles are used to form an upwards vector component, with the left and inferior muscles containing vector components in the opposite directions. Such rules would be modified for embodiments of the device that have only one electrode on each side or have greater than two electrodes on each side. Such rales would also be modified when controlling a l -D output device and when controlling a 3-D output device, FIG 9 shows how in accordance with the invention an individual is able to direct cursor 60 across a 2-D computer screen with a rule based system where the vectors a, b, c and d correlate respectively with the left superior auricu!aris muscle (a), the right superior auricularis muscle (b), the left posterior auricniaris muscle (c), and the right posterior auricu!aris muscle (d).
In another embodiment, the individual is told to move the cursor 60 in an intuitive manner while the system records the pattern of signals that represent each direction of motion. Sn this way, the system calibrates and adapts to each individual user, allowing for natural differences between individuals and provides a specialized control algorithm that is unique for every user,
FIG, 10 illustrates another example of the invention in which the pattern of signals produced in the implanted sensor electrodes i 1 moves a computer cursor 60 in a virtual 2~D environment towards an intended target 32 by extracting signal power and signal frequency information from each sensing electrode, information regarding the power of the EMG or ENG signal can be calculated by using a root mean squared (RMS) voltage calculation, a rectified voltage calculation, or by any other means to extract power information from the biosignai. Frequency information can be extracted from the biosignai by applying a fast Fourier transform (FFT) to the signal, or by other suitable known means applied to biosignais to characterize their frequencies. Information regarding the power and frequency characteristics of the signals from each electrode is then calculated and compared to these power and frequency characteristics from the other channels to determine which channel is being preferentially activated. The movement of the cursor 60 is thereby regulated or influenced by the relative contributions from each biosignai to reach the selected target. Referring to Figures 1 1 and 1 ! A, there is shown a convenient way of positioning skin contacting sensors in close proximity to the vestigia! auricular nerves/muscles by a user. A device, similar to what is used to mount lenses in eyeglasses, is indicated generally by numeral 62 and has a plastic frame 64 with pads 66 for supporting the frame on the bridge of the wearer's nose. The pads 66 are preferably conductive and function as a ground or reference electrode. It also has bows 68, 70 adapted to be supported by the ears of the wearer in the well-known manner. Disposed within the bows is the electronic signal processing circuitry that has been previously described. Mounted on the bows proximate their downward curve that wraps around the ears are one or more EMG electrodes 72,74,76 and 78 of the type previously described so positioned that they will closely overlay the vestigial auricular nerves and muscles, allowing pickup of EMG potentials when the frame 62 is being worn. As mentioned, the frame's bow members 68 and 70 also supports the electronics for performing the signal processing and signal transmission function earlier described in connection with the headset of Figure 5. Printed wiring is preferably employed to connect the ground electrode 66 and the EMG electrodes 72, 74, 76 and 78 to the electronic circuitry residing in the bows 68, 70.
To enhance comfort to the user, pads, as at 80, are positioned to rest on the skin where the external ears join the head. A suitably shaped pad 81 may also be provided at the point where the front portion of the frame engages the forehead. As shown in Fig. 11 A, an elastic band or strap 82 may encircle the back of the wearer's head to more firmly compress the electrodes 72, 74, 76, 78 against the skin at the site of the vestigial nerves and muscles for more intimate contact and to more firmly secure the device 62 in place.
Figure 12 illustrates a still further approach for positioning surface electrodes in relation to the vestigial auricular nerves and muscles shown in Figure 1 A. Here, an elastic headband 72 is shown being worn by a person so as to encircle the forehead and remainder of the skull at a location above the person's auricles. Built into the headband are electronic modules as at 73, 74 having exposed surface electrodes that are held in close contact with the person's skin at locations earlier identified In the discussion herein of Figures I and ί A. Like the headset of Figures 5A and 5B, the elastic headband of Figure 12 may have integrally formed appendages as at 75 that project down from the head encircling band and which carry electrodes corresponding to 43 and 44 of Figure S A, The appendages may include a plastic leaf spring member for urging the electrodes carried thereby against the skin. If needed, one or more straps 76 running over the top of the sknM and affixed at opposed ends to the elastic band may be used for added stability.
Many variations of the present invention within the scope of the appended claims will be apparent to those in the art once the principles described herein are read

Claims

What is claimed is:
S . An apparatus for enabling a person to control the real or virtual action or movement of an output device in at least one dimension comprising:
an electrical sensor located on a side of the person's head in electrical communication with a vestigial periauricular nerve or muscle;
said sensor being coupled through a communication channel to allow transmittal of information to an output device designating the action or position of a target location,
such that the output device performs the action or is moved toward or to the target location through real or virtual space.
2. The apparatus of claim 1 including bilateral sensing wherein said sensor comprises at least one electrical sensor supported on each side of the person's head in electrical communication with one of the vestigial periauricular nerve or muscle.
3. The apparatus of claim 2 and further including a pair of eyeglasses having a frame including a pair of bows, the at feast one electrical sensor is supported on each side of a person's head is affixed to the bows of the eyeglasses,
4. The apparatus of claim 2 and further including an elastic headband, the at least one electrical sensor supported on each side of a person's head is affixed to the elastic headband so as to overlay the one of the vestigial periauricular nerve or rnusc!e when the headband is being worn by the person,
5. The apparatus of claim 1 wherein the sensor comprises a plurality of sensors on at least one side of the head that are each in electrical communication with a periauricular nerve or muscle.
6. The apparatus of claim 5 and further including a frame including a nose engaging support and a pair of ear engaging bows and where the plurality of sensors on at least one side of the head is affixed to a bow of the frame.
7. The apparatus of claim 1 wherein the sensor is a surgically implanted electrode that is located under the skin of the person in electrical contact with a vestigial periauricular nerve or muscle. i
8. The apparatus of claim 1 wherein the sensor is a skin surface electrode that is placed on the skin of the person for receiving EMG signals from a vestigia! periauricular muscle.
9. The apparatus of claim ί and further including an elastic headband, the electrical sensor being affixed to the elastic headband so as to overlay the vestigia! periauricular nerve or muscle when the headband is being worn by the person.
10. The apparatus of claim 1 wherein the output device is at least one actuator for assisting handicapped or able bodied persons with respect to at least one member selected from disability, strength enhancement, sensor enhancement, computer or cursor manipulation, gaming devices including video games, the operation of appliances, vehicles and robotic devices in a hands-free manner.
11 . An apparatus for enabling a person to activate or control an output device in real or virtual space comprising:
at least a pair of electrical sensors said sensors being located on the left and right side of a person's head in electrical communication with a vestigial periauricular nerve or muscle and
said sensor being coupled through a communication channel to transmit information to an output device designating an action to be performed or the position of a target location in at least two dimensions,
such that the output device performs the action or is moved toward or to the target location.
12. The apparatus of claim ! I wherein the sensor comprises a plurality of sensors on each side of the head.
S3. The apparatus of claim 12 and further including an elastic headband, the plurality of sensors being affixed to the elastic headband so as to overlay the vestigial periauricular nerve or muscle when the headband is being worn by the person,
14. The apparatus of claim 1 ! wherein each sensor is a surgically implanted eiectrode that is located on each side of the head under the skin in electrical contact with a vestigia! periauricular nerve or muscle.
] 5. The apparatus of claim 1 1 wherein each of the sensors is a skin surface electrode that is placed on the skin of the person for receiving EMG signals from a vestigia! periauricular muscle.
16. The apparatus of claim 1 1 wherein the output device is at least one actuator for assisting handicapped or able bodied persons with respect to at least one member selected from disability, strength enhancement, sensor enhancement, computer or cursor manipulation, gaming devices including video games, the operation of appliances, vehicles and robotic devices in a hands-free manner.
17. The apparatus of claim 12 and further including a frame including a pair of bows joined together by a front piece supported by nose engaging pads and the plurality of electrodes are affixed to the bows which when worn position the plurality of electrodes on each side of the wearer's head in overlaying relation to the vestigial periauricular nerves and muscles.
18. A method for enabling a person to control an output device comprising: placing at least one electrical sensor on at least one side of a person's head in electrical communication with a vestigia! periauricular nerve or muscle and connecting said sensor to communicate through a channel to the output device for transmitting information about an action to be performed or designating the position of a target location, such that the output device performs said action or is moved toward or to the target location in real or virtual space.
1 . The method of claim 16 and further including the step of providing bilateral sensing wherein at least one electrical sensor is placed on each side of a person's head in electrical communication with the vestigial periauricular nerve or muscle.
20. The method of claim 18 including the step of placing a plurality of sensors on at least one side of the head in electrical communication with a periauricular nerve or muscle.
21. The method of claim 18 including the step of surgically implanting each electrical sensor under the skin of the person in electrical contact with a vestigial periauricular nerve or muscle.
22. The method of claim S 8 including the step of placing a skin surface electrode on the skin of the person for receiving EMG signals from a vestigia! periauricular muscle.
23. The method of claim 22 and further including the step of providing a frame comprising a front piece adapted to be supported by nose engaging pads when being worn and a pair of bows connected to the front piece and adapted to extend about the external ears of a wearer, affixing the skin surface electrodes to at least one bow of the frame and positioning said frame on the head of a person whereby the at least one skin surface electrode is in contact with the person's skin proximate the vestigia] periauricular muscle.
24. The method of claim 23 and further including the steps of providing an elastic band, affixing the elastic band to the bows and placing the frame on the head of the person such that the at least one skin surface sensor is in contact with the person's skin proximate the vestigial periauricular muscle and the elastic band is disposed along the rear of the person's head,
25. The method of claim 18 including the step of providing as said output device an actuator to assist handicapped or able bodied persons for a member selected from disability, strength enhancement, sensor enhancement, computer or cursor manipulation, gaming devices including video games, the operation of appliances, vehicles and robotic devices in a hands-free manner,
26. A method for enabling a person to control an output device comprising: placing at least one electrical sensors on the left side and at least one electrical sensor on the right side of a person's head in electrical contact with a vestigial periauricular nerve or muscle and
connecting each of the sensors to a communication channel for transmitting information to a moveable output device designating an action to be performed or the position of a target location,
such that the output device performs the action or is moved to or toward the target device.
27. The method of claim 26 including the step of placing a plurality of sensors on each side of the head in electrical communication with a periauricular nerve or muscle.
28. The method of claim 26 including the step of surgically implanting each electrode under the skin of the person in electrical contact with a vestigial periauricular nerve or muscle,
29. The method of claim 26 wherein each of the sensors is a skin surface electrode and including the step of placing each skin surface electrode on the skin of the person for receiving EMG signals from a vestigial periauricular muscle.
30. The method of claim 29 wherein the at least one sensor is affixed to a bow of a pair of eyeglasses and further comprising a step of positioning said pair of eyeglasses on the head of a person whereby the al least one skin surface sensor is in contact with the person's skin proximate the vestigial periauricular muscle.
31. The method of claim 26 wherein the electrical sensor is supported on a headband which when being warn positions the electrical sensors in contact with the vestigial periauricular nerve and muscle.
32. The method of claim 26 including the step of operating the output device is an actuator to assist handicapped or able bodied persons for a member selected from disability, strength enhancement, sensor enhancement, computer or cursor manipulation, gaming devices Including video games, the operation of appliances, vehicles and robotic devices in a hands-free manner.
33. The apparatus of claim 3 wherein the channel carries at least one wireless digital signal.
34. The apparatus of claim 1 1 wherein the channel carries at least one wireless digital signal.
35. The apparatus of claim 18 wherein the channel carries at least one wireless digital signal.
36. The apparatus of claim 26 wherein the channel carries at least one wireless digital signal.
PCT/US2013/062523 2012-10-01 2013-09-30 Control system and apparatus utilizing signals originating in the periauricular neuromuscular system WO2014055382A1 (en)

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