CN117839077A - Nystagmus electrical stimulation device and method of operation thereof - Google Patents

Nystagmus electrical stimulation device and method of operation thereof Download PDF

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Publication number
CN117839077A
CN117839077A CN202410257618.XA CN202410257618A CN117839077A CN 117839077 A CN117839077 A CN 117839077A CN 202410257618 A CN202410257618 A CN 202410257618A CN 117839077 A CN117839077 A CN 117839077A
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Prior art keywords
stimulation
electrode
feedback
nystagmus
switch
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Inventor
王文思
申鹏飞
王乐今
王天放
徐政
张旭斌
王舵
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Chaomu Technology Beijing Co ltd
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Chaomu Technology Beijing Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014External stimulators, e.g. with patch electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • A61B3/113Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions for determining or recording eye movement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/103Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1101Detecting tremor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014External stimulators, e.g. with patch electrodes
    • A61N1/3603Control systems
    • A61N1/36031Control systems using physiological parameters for adjustment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36046Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the eye

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biophysics (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Physiology (AREA)
  • Physics & Mathematics (AREA)
  • Ophthalmology & Optometry (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Surgery (AREA)
  • Human Computer Interaction (AREA)
  • Dentistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Pathology (AREA)
  • Electrotherapy Devices (AREA)

Abstract

The invention relates to the technical field of medical equipment, in particular to an nystagmus electric stimulation device and an operation method thereof, which can timely apply proper and accurate electric stimulation to the nystagmus, wherein the nystagmus electric stimulation device comprises: a stimulation electrode; a feedback electrode; an acquisition unit; an electrical stimulation source; the first switch connects the stimulating electrode and the feedback electrode to the acquisition unit; a second switch connects the stimulating electrode and the feedback electrode to an electrical stimulation source; the control unit recognizes the nystagmus state according to the signal of the acquisition unit so as to control the electric stimulation source to generate stimulation current; in the sampling period of stopping the electric stimulation, the first switch is communicated and the second switch is turned off, and the eye muscle biological voltage signals are collected by using the stimulating electrode and the feedback electrode and sent to the collecting unit to be provided for the control unit; in the stimulation period of applying the electric stimulation, the second switch is communicated and the first switch is turned off, and the stimulation electrode and the feedback electrode are communicated with the electric stimulation source to form a current loop, so that the stimulation current is applied to the eye muscle.

Description

Nystagmus electrical stimulation device and method of operation thereof
Technical Field
The invention relates to the technical field of medical equipment, in particular to an nystagmus electrical stimulation device and an operation method thereof.
Background
The electrical stimulation signals generated by the traditional extraocular muscle neuromuscular stimulator are only electrical stimulation signals which are correspondingly generated based on bioelectric signals generated by eye muscle contraction and have opposite directions, and the electrical stimulation signals cannot be distinguished from normal contraction (such as eyeball rotation control) or abnormal contraction (eyeball involuntary tremor), so that proper current stimulation cannot be timely applied, and the intensity and frequency of the electrical stimulation signals cannot be specifically adjusted to realize accurate electrical stimulation.
For this reason, a solution for precisely controlling the electrical stimulation is required.
Disclosure of Invention
The embodiment of the invention provides an nystagmus electric stimulation device and an operation method thereof, which can timely apply proper and accurate electric stimulation to nystagmus.
According to one aspect of the present invention, there is provided an nystagmus electrical stimulation device comprising:
a stimulation electrode that is in contact with a stimulation site of a treatment region of the eye muscle;
a feedback electrode in contact with a feedback portion for the processing region;
an acquisition unit;
an electrical stimulation source;
a switching unit comprising: a first switch selectively connecting the stimulation electrode and the feedback electrode to the acquisition unit, respectively; a second switch selectively connecting the stimulation electrode and the feedback electrode to the electrical stimulation source, respectively;
the control unit is connected with the switch unit, the acquisition unit and the electric stimulation source, and recognizes the tremor state of the eye muscles according to the signals provided by the acquisition unit so as to control the electric stimulation source to generate stimulation current applied to the eye muscles;
under the control of the control unit, in a sampling period of stopping electric stimulation, the first switch is communicated and the second switch is turned off, so that the stimulating electrode and the feedback electrode are opened to acquire a biological voltage signal of the treatment area of eye muscles, and the biological voltage signal is sent to the acquisition unit to be provided for the control unit; and in a stimulation period of applying electric stimulation, the second switch is communicated and the first switch is turned off, so that the stimulation electrode and the feedback electrode are communicated with the electric stimulation source to form a current loop, and the stimulation current is applied to the treatment area of the eye muscle.
Preferably, in any of the embodiments,
the first switch is connected to the signal acquisition unit through a signal amplifier.
Preferably, in any of the embodiments,
the stimulating electrode is connected to the positive electrode of the electric stimulation source through the second switch;
the feedback electrode is connected to the negative electrode of the electrical stimulation source through the second switch.
Preferably, in any of the embodiments,
corresponding electrode groups are respectively arranged for different treatment areas, and each electrode group comprises at least one stimulating electrode and at least one feedback electrode.
Preferably, in any of the embodiments,
a plurality of the feedback electrodes are disposed at different positions along the stimulation lead in the body, the plurality of feedback electrodes being selectively connected to the electrical stimulation source via a plurality of feedback switches, respectively.
Preferably, in any embodiment, further comprising:
an image acquisition module for acquiring an eyeball image is connected to the control unit.
Preferably, in any of the embodiments,
the control unit includes: and a neural network analysis module.
According to another aspect of the present invention there is provided a method of operation for operating an nystagmus electrical stimulation device as hereinbefore described, comprising:
opening the stimulating electrode and the feedback electrode during the sampling period to acquire a bio-voltage signal of the treatment region of the eye muscle, and transmitting the bio-voltage signal to the acquisition unit to be provided to the control unit;
and in the stimulation period, the stimulation electrode and the feedback electrode are communicated with the electric stimulation source to form a current loop, and the stimulation current determined by the control unit according to the tremor state of the eye muscles is applied to the treatment area of the eye muscles.
Preferably, in any of the embodiments,
when the stimulation electrode applying the stimulation current to the eye muscle is determined to be invalid, one feedback electrode of the feedback electrodes is connected with the negative electrode of the electric stimulation source to be connected with the positive electrode of the electric stimulation source, so that the feedback electrode is modified to be a new stimulation electrode.
Preferably, in any of the embodiments,
the manner of determining the failure of the stimulating electrode includes: the stimulation electrode is modified to a new feedback electrode by modifying the connection of at least one of the plurality of stimulation electrodes to the positive electrode of the electrical stimulation source to the negative electrode of the electrical stimulation source, and if none of one or more consecutive stimulation periods receives a current signal from the new feedback electrode, the stimulation electrode is determined to be failed.
According to the nystagmus electric stimulation device and the operation method thereof provided by the embodiments of the invention, proper and accurate electric stimulation can be timely applied to the nystagmus.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following discussion will discuss the embodiments or the drawings required in the description of the prior art, and it is obvious that the technical solutions described in connection with the drawings are only some embodiments of the present invention, and that other embodiments and drawings thereof can be obtained according to the embodiments shown in the drawings without inventive effort for a person skilled in the art.
Fig. 1 is a schematic diagram of the structure of an nystagmus electrostimulation device according to an embodiment of the present invention.
Fig. 2 is a schematic diagram of a structure employing a plurality of feedback electrodes according to an embodiment of the present invention.
Fig. 3 is a schematic diagram of a stimulation electrode and a plurality of feedback electrodes connected to an electrical stimulation source according to an embodiment of the invention.
Detailed Description
The following description of the embodiments of the present invention will be made in detail with reference to the accompanying drawings, wherein it is apparent that the embodiments described are only some, but not all embodiments of the present invention. All other embodiments, which can be made by a person of ordinary skill in the art without the need for inventive faculty, are within the scope of the invention, based on the embodiments described in the present invention.
The embodiment of the invention provides an nystagmus electric stimulation device and an operation method thereof, which can timely apply proper and accurate electric stimulation to nystagmus.
According to one aspect of the present invention, there is provided an nystagmus electrical stimulation device comprising:
a stimulation electrode that is in contact with a stimulation site of a treatment region of the eye muscle;
a feedback electrode in contact with a feedback portion for the processing region;
an acquisition unit;
an electrical stimulation source;
a switching unit comprising: a first switch selectively connecting the stimulation electrode and the feedback electrode to the acquisition unit, respectively; a second switch selectively connecting the stimulation electrode and the feedback electrode to the electrical stimulation source, respectively;
the control unit is connected with the switch unit, the acquisition unit and the electric stimulation source, and recognizes the tremor state of the eye muscles according to the signals provided by the acquisition unit so as to control the electric stimulation source to generate stimulation current applied to the eye muscles;
under the control of the control unit, in a sampling period of stopping electrical stimulation, the first switch is communicated and the second switch is turned off, and the biological voltage signals of the treatment area of the eye muscle are acquired by using the stimulation electrode and the feedback electrode and sent to the acquisition unit to be provided for the control unit; and in a stimulation period of applying electric stimulation, the second switch is communicated and the first switch is turned off, so that the stimulation electrode and the feedback electrode are communicated with the electric stimulation source to form a current loop, and the stimulation current is applied to the treatment area of the eye muscle.
In this way, the voltage signals (bio-voltage signals) at both ends of the eye muscle treatment area are measured by the stimulating electrode and the feedback electrode during the sampling period (when the stimulating electrode and the feedback electrode are disconnected from the electric stimulus source) and supplied to the control unit via the collecting unit, and the control unit can identify the state of nystagmus based on the received bio-voltage signals and control the electric stimulus source to generate a suitable stimulating current when the eye muscle is determined to be in the involuntary tremor state, and the stimulating current is applied to the eye muscle during the stimulating period or when the electric stimulus needs to be immediately applied (for example, when the involuntary tremor of the eyeball is determined to occur), so that the eye muscle is adjusted to the normal state, thereby realizing the timely adjustment of the involuntary tremor of the eyeball.
Therefore, the electro-stimulation device for nystagmus provided by the embodiment of the invention can timely apply proper and accurate electro-stimulation to the nystagmus.
Preferably, in any embodiment, the first switch is connected to the signal acquisition unit through a signal amplifier.
Preferably, in any embodiment, the stimulation electrode is connected to the positive pole of the electrical stimulation source through the second switch; the feedback electrode is connected to the negative electrode of the electrical stimulation source through the second switch.
Preferably, in any embodiment, corresponding electrode groups are respectively arranged for different treatment areas, and each electrode group comprises at least one stimulating electrode and at least one feedback electrode.
Alternatively, in any embodiment, the different electrode sets may share one and the same feedback electrode.
Alternatively, in either embodiment, the different electrode sets may share one and the same stimulating electrode.
Optionally, in any embodiment, the different treatment areas are distributed along the stimulation lead. In this way, the respective electrodes (stimulation electrode and feedback electrode) for processing the different processing areas (e.g. acquiring bio-voltage signals and/or applying stimulation currents) are arranged accordingly.
Alternatively, in either embodiment, multiple feedback electrodes, each for a different treatment zone, are arranged along the stimulation lead and are separate from each other (as may be shown in the embodiment of fig. 2, for example).
Optionally, in either embodiment, a plurality of stimulation electrodes, each for a different treatment area, are arranged at the inner end of the stimulation lead (as may be shown for example in the embodiment of fig. 2).
Optionally, in any embodiment, the stimulation electrodes and feedback electrodes in a set include a pair of stimulation electrodes and feedback electrodes (i.e., a pair of stimulation electrodes and feedback electrodes).
Optionally, in any embodiment, the stimulation electrodes and feedback electrodes in a set include a pair of stimulation electrodes and feedback electrodes (i.e., a pair of stimulation electrodes and feedback electrodes) and additional stimulation electrodes. In this way, the additional stimulation electrode may serve as a back-up stimulation electrode.
Optionally, in any embodiment, the stimulation electrodes and feedback electrodes in a set include a pair of stimulation electrodes and feedback electrodes (i.e., a pair of stimulation electrodes and feedback electrodes) and an additional feedback electrode. In this way, the additional stimulation electrode may serve as a back-up feedback electrode.
Thus, in one set of electrodes, in addition to the pair of stimulation electrodes and feedback electrodes, a third electrode (stimulation electrode or feedback electrode) is included for the need from time to time.
Alternatively, in any embodiment, two stimulation electrodes and one feedback electrode may be included in the electrode set, where the two stimulation electrodes are disposed at different stimulation sites in the same treatment area or at different stimulation sites in different treatment areas. Thus, the feedback electrode can be selectively coupled to the desired stimulation electrode to acquire a bio-voltage signal or to apply a stimulation current to the desired stimulation site, as desired.
Alternatively, in any embodiment, the electrode set may include one stimulation electrode and two feedback electrodes, where the two feedback electrodes are disposed at different feedback sites. Thus, the stimulating electrode can be selectively connected with the feedback electrode as required to collect the biological voltage signal or control the application range of the stimulating current.
In embodiments of the present invention, if involuntary tremor of the eye is detected as a result of involuntary movement of the eye muscle (e.g., toward an involuntary left turn), the application of a stimulating current to the eye muscle via a stimulating electrode of an electrode set disposed on the eye muscle may be controllably adjusted (e.g., by applying a stimulating current to the extraocular rectus muscle to interrupt or dampen the involuntary movement of the eye muscle) so that the eye is maintained substantially stationary (e.g., no involuntary left turn occurs), i.e., in a substantially normal state, thereby enabling timely adjustment of the involuntary tremor of the eye.
However, in other embodiments of the invention, the abnormal movement of the eye muscles may not be directly interfered with, but the abnormal tremor of the eyeball may be adjusted in time in an indirect manner.
Optionally, in any embodiment, a first electrode set including a first stimulation electrode and a first feedback electrode is provided for the treatment region of the first eye muscle, and a second electrode set including a second stimulation electrode and a second feedback electrode is provided for the treatment region of the second eye muscle with opposite motion to the first eye muscle. Thus, the first electrode group and the second electrode group are respectively arranged on the first eye muscle and the second eye muscle with opposite movement actions or effects (for example, the first eye muscle and the second eye muscle respectively can enable the eyeballs to move oppositely when contracting and exerting force, such as rotation), and if involuntary tremor (such as towards abnormal left rotation) of the eyeballs caused by abnormal movement (such as contraction) of the first eye muscle is detected, the second eye muscle can be subjected to equal-force but opposite-direction adjusting movement (such as contraction) through the second stimulating electrode of the electrode group arranged on the second eye muscle, so that the eyeballs can keep basically motionless (such as no abnormal left rotation), namely, keep basically normal state. And vice versa. That is, for abnormal movements of the first eye muscle, the second eye muscle is subjected to an adjusting movement (e.g., contraction) of equal force but opposite direction by applying a moderate stimulus current, so that the forces of the first eye muscle and the second eye muscle (e.g., the internal rectus muscle and the external rectus muscle) with opposite movement actions or effects cancel each other out to keep the eyeball substantially fixed without abnormal tremors occurring, thereby achieving timely adjustment of the abnormal tremors of the eyeball.
Preferably, in any embodiment, a plurality of said feedback electrodes (four feedback electrodes 1-4 are shown in the embodiment of fig. 2) are arranged at different positions along the stimulation lead (the stimulation lead 120 and its housing 130 are shown in the embodiment of fig. 2) in the body, said plurality of feedback electrodes being selectively connected to said electrical stimulation source via a plurality of feedback switches, respectively. Thus, the feedback electrodes for receiving the stimulation current can be controlled by turning on and off the different feedback switches, so that the feedback electrodes and the stimulation electrodes (for example, four stimulation electrodes arranged at the top in the embodiment shown in fig. 2) are adopted to operate in a pairing manner, and the range of the stimulation current flowing through the human tissue (for example, eye muscle) can be further controlled (for example, as seen in the embodiment shown in fig. 3, n feedback electrodes 1-n are respectively controlled to be turned on and off by respective feedback switches K1-Kn).
The stimulation leads described herein may extend through subcutaneous tunnels formed in subcutaneous tissue of the human body (e.g., by manual penetration), avoiding tissue such as muscles, nerves, blood vessels, etc. of the human body, for effecting the associated connection of the stimulation electrode and the feedback electrode.
Optionally, in either embodiment, the stimulation lead includes a lead channel internally provided with electrode connection wires to electrically connect the stimulation electrodes and corresponding feedback electrodes (e.g., stimulation electrodes and feedback electrodes in the same electrode set).
Optionally, in any embodiment, a plurality of electrode connection lines electrically connect the respective stimulation electrodes and corresponding feedback electrodes (e.g., stimulation electrodes and feedback electrodes in the same electrode set) through the lead channels, respectively.
Optionally, in any embodiment, at least two of the plurality of electrode connecting wires passing through the stimulation lead share a lead channel.
Optionally, in any embodiment, the stimulation lead includes a plurality of parallel extending lead channels within, each of which is provided with electrode connection wires for electrically connecting the stimulation electrodes and corresponding feedback electrodes (e.g., stimulation electrodes and feedback electrodes in the same electrode set).
Optionally, in any embodiment, the electrode connecting wire comprises an elastic portion. In this way, the electrode connection lines can be adapted to elongate as needed to avoid damage or breakage.
Optionally, in any embodiment, the stimulation site of the stimulation electrode is disposed at a junction between the eye muscle and a nerve innervating the eye muscle motor. Thus, the stimulating current can be applied through the stimulating electrode to regulate and control the movement (especially abnormal movement) of the eye muscles, so as to precisely regulate and control the abnormal tremor of the eyeball.
Alternatively, in either embodiment, the stimulation site of the stimulation electrode may be disposed at the junction between the inside of the external rectus muscle of the eye and the nerve innervating the movements of the external rectus muscle of the eye.
Optionally, in any embodiment, the eye muscles in contact with the stimulation site of the stimulation electrode include, but are not limited to, at least one of: upper rectus, lower rectus, inner rectus, outer rectus, upper oblique, lower oblique. It is well known that the eye muscles referred to herein are those having an effect on the tremor of the eye, in particular on abnormal movements of the eye, i.e. subjects in need of electrical stimulation regulation in the present invention.
Optionally, in any embodiment, the stimulation electrode is sutured to the stimulation site of the treatment area. In this way, a reliable contact of the stimulation electrode and the stimulation site is ensured.
Alternatively, in either embodiment, impedance measurements may be used to detect whether the connection of the stimulation electrode to the stimulation site is tight.
Alternatively, in either embodiment, the feedback electrode is positioned in a subcutaneous tunnel (e.g., formed by manual penetration) formed in the subcutaneous tissue of the human body, and the process of post-operative tissue restoration may naturally be in intimate contact with the tissue to create a fixation effect.
Optionally, in any embodiment, the feedback electrode is in contact with a feedback site located in the eye muscle.
Optionally, in any embodiment, the feedback electrode is in contact with a feedback site located in the treatment region of the eye muscle.
Optionally, in any embodiment, the feedback portion of the feedback electrode and the stimulation portion of the stimulation electrode used in conjunction with the feedback electrode are located at opposite ends of the treatment region, respectively.
Optionally, in any embodiment, the feedback portion of the feedback electrode and the stimulation portion of the stimulation electrode used in conjunction with the feedback electrode are located at opposite ends of the eye muscle, respectively.
Optionally, in any embodiment, the feedback electrode is in contact with a feedback site located outside the eye muscle.
Optionally, in any embodiment, the feedback electrode is in releasable contact with the feedback site. That is, the position of the feedback electrode can be finely adjusted as needed, for example, from one feedback position to another.
Optionally, in any embodiment, further comprising:
a first collection electrode in contact with a first portion of the treatment region of the eye muscle;
a second collection electrode in contact with a second portion of the treatment region of the eye muscle;
wherein the first and second acquisition electrodes acquire a bio-voltage signal of the treatment region of eye muscle and transmit the bio-voltage signal to the acquisition unit.
In this way, the first and second acquisition electrodes can be used exclusively for acquiring eye muscle bio-voltage signals without affecting the application of electrical stimulation to the eye muscle using the stimulation electrode and the feedback electrode, which can operate in parallel.
Preferably, in any embodiment, the method may further include: an image acquisition module for acquiring an eyeball image is connected to the control unit. In this way, the eyeball images acquired in real time or at fixed time can be related to the corresponding bioelectric signals through the time attribute, and whether the nystagmus and the specific form thereof (such as whether the nystagmus is non-autonomous requiring the intervention of electric stimulation) occur or not can be judged through comparing the captured plurality of eyeball images in the preset time period, so that the support can be provided for the control unit to identify the nystagmus state.
Optionally, in any embodiment, the image acquisition module is connected to a control unit located outside the body by wireless communication.
Optionally, in any embodiment, the acquisition unit is connected to the control unit by wireless communication.
Optionally, in any embodiment, the control unit further comprises: nystagmus recognition module, which contains a recognition algorithm (which may include, for example, a trained neural network model).
Preferably, in any embodiment, the control unit comprises: and a neural network analysis module. The neural network analysis module may provide an analysis of nystagmus status based on the signals/information from the acquisition unit.
According to another aspect of the present invention there is provided a method of operation for operating an nystagmus electrical stimulation device as hereinbefore described, comprising:
opening the stimulating electrode and the feedback electrode during the sampling period to acquire a bio-voltage signal of the treatment region of the eye muscle, and transmitting the bio-voltage signal to the acquisition unit to be provided to the control unit;
and in the stimulation period, the stimulation electrode and the feedback electrode are communicated with the electric stimulation source to form a current loop, and the stimulation current determined by the control unit according to the tremor state of the eye muscles is applied to the treatment area of the eye muscles.
By the operation method of the nystagmus electric stimulation device provided by the embodiment of the invention, proper and accurate electric stimulation can be timely applied to the nystagmus.
Preferably, in any embodiment, when it is determined that the stimulation electrode applying the stimulation current to the eye muscle fails, the connection of one of the feedback electrodes to the negative electrode of the electrical stimulation source is modified to be connected to the positive electrode of the electrical stimulation source, so that the feedback electrode is modified to be a new stimulation electrode.
Optionally, in any embodiment, when the feedback electrode is determined to be invalid, the connection between one of the plurality of magnetic pole electrodes and the positive electrode of the electric stimulation source is modified to be connected with the negative electrode of the electric stimulation source, so that the stimulation electrode is modified to be a new feedback electrode.
It will be appreciated that the stimulating and feedback electrodes perform their respective functions due to the different polarities of the connections to the electrical stimulation source, and in actual use, may themselves be of the same construction so as to be interchangeable with each other, and that alternative use may be achieved by modifying the polarity connection to the electrical stimulation source when required (e.g. in the event of failure of one of the two) so as to improve the adaptability of the nystagmus electrical stimulation device.
Alternatively, in either embodiment, the stimulation electrodes and feedback electrodes arranged in a group may be used interchangeably by reversing the polarity of the electrical connection so that the original feedback electrode becomes the new stimulation electrode that delivers current and so that the original stimulation electrode becomes the new feedback electrode that receives current, thereby causing their stimulation points to swap positions.
Optionally, in any embodiment, the stimulation electrode comprises a backup stimulation electrode, and when it is determined that the stimulation electrode that applies the stimulation current to the eye muscle fails, applying a stimulation current to the eye muscle with the backup stimulation electrode.
Optionally, in any embodiment, the stimulating electrode comprises a spare stimulating electrode, and when it is determined that both the stimulating electrode and the spare stimulating electrode applying the stimulating current to the eye muscle are failed, one feedback electrode of the plurality of feedback electrodes is modified to be connected to the negative electrode of the electrical stimulation source, so as to be modified to be a new stimulating electrode.
That is, when the stimulation electrode that applies the stimulation current to the eye muscle fails (e.g., malfunctions), the spare stimulation electrode is preferentially used to replace the failed stimulation electrode to continue operation; when the stimulating electrode and the standby stimulating electrode which apply stimulating current to the eye muscle are failed, the electrode connection of one feedback electrode can be modified to be converted into a new stimulating electrode to continue to work.
Preferably, in any embodiment, determining the manner in which the stimulation electrode fails may comprise: the stimulation electrode is modified to a new feedback electrode by modifying the connection of at least one of the plurality of stimulation electrodes to the positive electrode of the electrical stimulation source to the negative electrode of the electrical stimulation source, and if none of one or more consecutive stimulation periods receives a current signal from the new feedback electrode, the stimulation electrode is determined to be failed.
Optionally, in any embodiment, determining the manner in which the stimulation electrode fails may include: and modifying the stimulation electrode in the non-working state into a new feedback electrode by modifying the connection between the stimulation electrode in the non-working state in the plurality of stimulation electrodes and the positive electrode of the electric stimulation source into the connection between the stimulation electrode in the non-working state and the negative electrode of the electric stimulation source so as to judge whether the stimulation electrode is invalid, and if one or more continuous stimulation periods do not receive a current signal from the new feedback electrode, determining that the stimulation electrode is invalid. Thus, when it is necessary to determine/judge whether the stimulating electrode is out of order, the stimulating electrode in the active state (applying a stimulating current to the eye muscle) can be kept unchanged, while the electrode connection of the other stimulating electrode in the inactive state is modified to be converted into a new feedback electrode, thereby judging whether the stimulating electrode in the active state is out of order.
Optionally, in any embodiment, only a portion(s) of the plurality of stimulation electrodes apply the electrical stimulation during the stimulation period. In this way, only a portion of the stimulation electrodes are used to apply electrical stimulation to the eye muscles, while the remaining stimulation electrodes are used as spares, and once the used stimulation electrodes are found to fail (e.g., the stimulation electrodes are determined to fail when none of one or more consecutive stimulation cycles receives a stimulation current signal from the corresponding feedback electrode), the operation of switching to the sparing stimulation electrode to apply electrical stimulation may be performed, on the one hand, to ensure operational reliability of the nystagmus electrical stimulation device, and on the other hand, to also alternate the use of multiple stimulation electrodes to extend the operational life of the nystagmus electrical stimulation device.
Optionally, in any embodiment, a plurality of said electrical stimulation sources are provided. In this way, the redundant arrangement of a plurality of electrical stimulation sources not only can switch to other electrical stimulation sources to work when one electrical stimulation source fails, but also can respectively serve different electrodes (such as a stimulation electrode or a feedback electrode) or electrode groups (comprising the stimulation electrode and the feedback electrode which are matched with each other) according to requirements.
Optionally, in any embodiment, the electrical stimulation source comprises two electrical stimulation sources of opposite polarity arrangement. In this way, when the stimulation electrode modification polarity connection needs to be converted into a new feedback electrode, or the feedback electrode modification polarity connection needs to be converted into a new stimulation electrode, the conversion can be conveniently and quickly realized by switching to another electrical stimulation source with opposite polarity setting by using the corresponding switching device.
Optionally, in any embodiment, when all stimulation electrodes are determined to be malfunctioning, an alarm is sent to the control unit to prompt replacement of the stimulation leads that are in the body.
Optionally, in any embodiment, the acquired eye image is provided to the control center and the acquired bioelectric signal (e.g., the bioelectric voltage signal) is provided to the control center after adding the temporal attribute, the eye image being associated with the bioelectric signal according to the temporal attribute. In this way, by comparing a plurality of captured eye images over a preset period of time, it can be determined whether nystagmus and its specific form (e.g. whether it is non-autonomous nystagmus requiring electro-stimulatory intervention) occurs, thereby providing support for the control unit to identify the state of nystagmus.
Optionally, in any embodiment, the image acquisition module provides the eyeball image to the control center in real time or periodically.
Optionally, in any embodiment, the acquisition unit provides the bioelectric signals to the control center in real time or periodically.
Optionally, in any embodiment, the operation of the image acquisition module to provide the eyeball image to the control center and the operation of the acquisition unit to provide the bioelectric signal to the control center are synchronized, or are spaced by a predetermined time difference.
Optionally, in either embodiment, the form of the eye muscle tremor is identified by manual identification or by an identification algorithm to obtain the identification result.
Optionally, in any embodiment, the collected bioelectrical signals are marked based on the recognition result.
Optionally, in any embodiment, the labeled bioelectric signal data samples are sent to a neural network analysis module for iterative training, and the analysis result of the neural network analysis module is improved by a machine learning mode.
Optionally, in any embodiment, the analysis result of the neural network analysis module is output after the analysis result reaches a preset accuracy.
Optionally, in any embodiment, the predicted cycle of nystagmus is calculated according to an analysis result of the neural network analysis module.
Optionally, in any embodiment, training improvement is performed on the analysis and identification of the state of eye tremor by the neural network analysis module by comparing and analyzing a plurality of captured eyeball images within a preset period of time by utilizing the correlation between the acquired eyeball images and the bioelectric signals (such as the bioelectric voltage signals) after adding time attributes before the stimulation period.
Optionally, in any embodiment, the correlation between the acquired eye images and the bioelectrical signals (e.g., the bioelectrical voltage signals) after the addition of the temporal attribute is utilized during a predetermined improvement period (e.g., a period during which no electrical stimulation intervention for involuntary nystagmus is required, such as a daily rest period), and the analysis of the eye muscle tremor state analysis recognition by the neural network analysis module is improved by comparing the captured plurality of eye images during the predetermined period.
Optionally, in any embodiment, the control unit configures default electrical stimulation control parameters for different nystagmus forms.
Optionally, in any embodiment, the nystagmus form may comprise: up and down tremors, left and right tremors, rotational tremors, and the like.
Optionally, in any embodiment, the acquired bio-voltage signal is labeled. For example, nystagmus forms may be included, such as 0 for non-occurrence of nystagmus (or no labeling), 1 for side-to-side tremor, 2 for up-and-down tremor, and 3 for rotational tremor.
Optionally, in either embodiment, the marking of the acquired bio-voltage signal is performed by an identification model (which may be in an nystagmus identification module, for example), or by manual identification.
Optionally, in either embodiment, the control unit provides a manual mode in which the user is allowed to fine tune the parameters of the stimulation current according to his own electrical stimulation experience.
Optionally, in any embodiment, the control parameters of the electrical stimulation by the control unit may comprise at least one of:
stimulation cycles (stimulation cycles may include nystagmus prediction cycles);
an electrical stimulation pattern (e.g., continuous electrical stimulation over a stimulation period, or pulsed electrical stimulation) and its associated electrical parameters;
electrical stimulation intensity (e.g., magnitude of stimulation current and upper limit thereof, electrical stimulation discharge duration and upper limit thereof);
the electrical stimulation range (e.g., by feedback electrodes at different locations).
Optionally, in any embodiment, during the long-term use of the user, the trend of the predicted period of the nystagmus is analyzed and judged, if the predicted period is judged to be longer, one or more electrical stimulation control parameters (for example, the intensity of the stimulation current is reduced) are adaptively reduced so as to improve the use experience of the user (for example, when the interval time of the nystagmus is longer and longer, the condition is relieved, and at this time, the electrical stimulation needs to be reduced so as to improve the experience of the user); when the prediction period is judged to be shortened, the stimulation period and other electric stimulation control parameters are adaptively adjusted so that the nystagmus prediction period is lengthened.
In the operation method for operating the aforementioned nystagmus electric stimulation device provided according to the embodiments of the present invention, the control unit recognizes the nystagmus state according to the signal provided by the acquisition unit to control the electric stimulation source to generate the stimulation current applied to the eye muscle. The control unit may be preset or connected to a trained recognition model (for example, may be in the nystagmus recognition module), and may recognize the state and form of nystagmus (for example, normal tremor or abnormal tremor) according to the characteristics (for example, size, frequency, waveform rule, etc.) of the bioelectric signal actually measured or collected in actual use, and may predict the change trend (for example, tremor period) or form (for example, up-down tremor left-right tremor) of the nystagmus abnormal tremor.
Optionally, in either embodiment, the control unit identifies the state and form of nystagmus by comparing the acquired bio-voltage signal with identification model data (e.g. from a database).
Optionally, in any embodiment, the identification model data is used for machine learning of an identification model (e.g. may be in the nystagmus identification module described previously).
Optionally, in any embodiment, the identification model data comprises at least in part eyeball data from the same class of patients (e.g., may be from a database).
Optionally, in any embodiment, the identification model data includes, at least in part, historical movement data of the user itself (e.g., position, movement velocity, and acceleration of the eyeball, etc.).
Optionally, in any embodiment, the identification model data includes, at least in part, real-time movement data of the user itself (e.g., position, movement velocity, and acceleration of the eye, etc.).
Optionally, in any embodiment, the identification model data comprises, at least in part, visual assessment test results of the user.
Optionally, in any embodiment, the identification model data is updated complementarily by the acquired bio-voltage signals.
Optionally, in any embodiment, the control unit sends the acquired bio-voltage signals to an identification model (which may be in the nystagmus identification module described previously, for example) for machine learning.
Optionally, in either embodiment, the user's historical motion data is subjected to a fitting analysis using anatomical and physiological principles to derive nystagmus motion patterns to form a predictive eye movement recognition model.
Optionally, in any embodiment, the recognition model (e.g. may be in the nystagmus recognition module described previously) comprises, for example, a self-encoder.
Optionally, in either embodiment, the recognition model (which may be in the nystagmus recognition module described previously, for example) takes as input user historical motion data and takes as output based on nystagmus velocity and amplitude for training and learning. In this way, machine learning is achieved through multiple iterations and optimizations, thereby improving accuracy in predicting the speed, magnitude, and state of the tremor of the eye ball.
Optionally, in any embodiment, the historical motion data or the real-time motion data of the user is filtered according to an adaptive filtering algorithm.
Alternatively, in either embodiment, the recognition model may employ historical motion data of like patients to form a machine-learned training set.
Optionally, in either embodiment, the recognition model uses the user historical motion data to form a machine-learned training set and verification set.
Alternatively, in either embodiment, the recognition model forms a training set with 60-80% of the user's historical motion data and a validation set with 20-40% of the user's historical motion data.
Optionally, in any embodiment, the identification model uses at least a portion of the acquired bio-voltage signals for forming a machine-learned validation set.
Optionally, in any embodiment, the identification model uses at least a portion of the acquired bio-voltage signals for forming a machine-learned test set.
Optionally, in either embodiment, the recognition model forms a machine-learned training set and verification set with equal amounts of user historical motion data, respectively, and cross-verifies the results.
Optionally, in either embodiment, the recognition model forms a machine-learned training set and verification set, respectively, at 50% of the user's historical motion data, and cross-verifies the results.
Optionally, in any embodiment, after adjusting parameters of the nystagmus electrical stimulation device according to the user situation, the training set or the verification set of the recognition model machine learning is adjusted or updated or replaced by the acquired bio-voltage signal.
Fig. 1 is a schematic diagram of the structure of an nystagmus electrostimulation device according to an embodiment of the present invention.
An nystagmus electrostimulation device is visible in the embodiment shown in fig. 1, characterized in that it comprises:
a stimulation electrode that is in contact with a stimulation site of a treatment region of the eye muscle;
a feedback electrode in contact with a feedback portion of the processing region;
an acquisition unit;
an electrical stimulation source;
a switching unit comprising: a first switch (switch 1) selectively connecting the stimulating electrode and the feedback electrode, respectively, to the acquisition unit; a second switch (switch 2) selectively connecting the stimulation electrode and the feedback electrode, respectively, to the electrical stimulation source;
the control unit is connected with the switch unit, the acquisition unit and the electric stimulation source, and recognizes the tremor state of the eye muscles according to the signals provided by the acquisition unit so as to control the electric stimulation source to generate stimulation current applied to the eye muscles;
under the control of the control unit, in a sampling period of stopping electric stimulation, the first switch is communicated and the second switch is turned off, so that the stimulating electrode and the feedback electrode are opened to acquire a biological voltage signal of the treatment area of eye muscles, and the biological voltage signal is sent to the acquisition unit to be provided for the control unit; and in a stimulation period of applying electric stimulation, the second switch is communicated and the first switch is turned off, so that the stimulation electrode and the feedback electrode are communicated with the electric stimulation source to form a current loop, and the stimulation current is applied to the treatment area of the eye muscle.
According to the nystagmus electric stimulation device and the operation method thereof provided by the embodiments of the invention, proper and accurate electric stimulation can be timely applied to the nystagmus.
It is noted that relational terms such as first and second, and the like, are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the statement "comprises one" does not exclude that an additional identical element is present in a process, method, article or apparatus that comprises the element.
In the description of elements herein, a plurality of juxtaposed features connected by "and/or" is meant to encompass one or more (or one or more) of these juxtaposed features. For example, the meaning of "a first element and/or a second element" is: one or more of the first element and the second element, i.e., only the first element, or only the second element, or both the first element and the second element (both present).
The various embodiments provided in this invention may be combined with each other as desired, e.g., features of any two, three or more embodiments may be combined with each other to form new embodiments of the invention, which are also within the scope of the invention unless stated otherwise or contradicted by skill.
The foregoing description of the exemplary embodiments of the invention is not intended to limit the invention to the precise form disclosed, and any modifications, equivalents, and variations which fall within the spirit and scope of the invention are intended to be included in the scope of the invention.

Claims (10)

1. An nystagmus electrical stimulation device, comprising:
a stimulation electrode that is in contact with a stimulation site of a treatment region of the eye muscle;
a feedback electrode in contact with a feedback portion for the processing region;
an acquisition unit;
an electrical stimulation source;
a switching unit comprising: a first switch selectively connecting the stimulation electrode and the feedback electrode to the acquisition unit, respectively; a second switch selectively connecting the stimulation electrode and the feedback electrode to the electrical stimulation source, respectively;
the control unit is connected with the switch unit, the acquisition unit and the electric stimulation source, and recognizes the tremor state of the eye muscles according to the signals provided by the acquisition unit so as to control the electric stimulation source to generate stimulation current applied to the eye muscles;
under the control of the control unit, in a sampling period of stopping electrical stimulation, the first switch is communicated and the second switch is turned off, and the biological voltage signals of the treatment area of the eye muscle are acquired by using the stimulation electrode and the feedback electrode and sent to the acquisition unit to be provided for the control unit; and in a stimulation period of applying electric stimulation, the second switch is communicated and the first switch is turned off, so that the stimulation electrode and the feedback electrode are communicated with the electric stimulation source to form a current loop, and the stimulation current is applied to the treatment area of the eye muscle.
2. The nystagmus electrical stimulation device of claim 1,
the first switch is connected to the signal acquisition unit through a signal amplifier.
3. The nystagmus electrical stimulation device of claim 1,
the stimulating electrode is connected to the positive electrode of the electric stimulation source through the second switch;
the feedback electrode is connected to the negative electrode of the electrical stimulation source through the second switch.
4. The nystagmus electrical stimulation device of claim 1,
corresponding electrode groups are respectively arranged for different treatment areas, and each electrode group comprises at least one stimulating electrode and at least one feedback electrode.
5. The nystagmus electrical stimulation device of claim 1,
a plurality of the feedback electrodes are disposed at different positions along the stimulation lead in the body, the plurality of feedback electrodes being selectively connected to the electrical stimulation source via a plurality of feedback switches, respectively.
6. The nystagmus electrical stimulation device of claim 1, further comprising:
an image acquisition module for acquiring an eyeball image is connected to the control unit.
7. The nystagmus electrical stimulation device of claim 1,
the control unit includes: and a neural network analysis module.
8. A method of operation for operating an nystagmus electrostimulation device according to any of the claims 1 to 7, comprising:
acquiring a bio-voltage signal of the treatment region of the eye muscle using the stimulating electrode and the feedback electrode during the sampling period, and transmitting the bio-voltage signal to the acquisition unit to be provided to the control unit;
and in the stimulation period, the stimulation electrode and the feedback electrode are communicated with the electric stimulation source to form a current loop, and the stimulation current determined by the control unit according to the tremor state of the eye muscles is applied to the treatment area of the eye muscles.
9. The method of operation of claim 8, wherein,
when the stimulation electrode applying the stimulation current to the eye muscle is determined to be invalid, one feedback electrode of the feedback electrodes is connected with the negative electrode of the electric stimulation source to be connected with the positive electrode of the electric stimulation source, so that the feedback electrode is modified to be a new stimulation electrode.
10. The method of operation of claim 9, wherein,
the manner of determining the failure of the stimulating electrode includes: the stimulation electrode is modified to a new feedback electrode by modifying the connection of at least one of the plurality of stimulation electrodes to the positive electrode of the electrical stimulation source to the negative electrode of the electrical stimulation source, and if none of one or more consecutive stimulation periods receives a current signal from the new feedback electrode, the stimulation electrode is determined to be failed.
CN202410257618.XA 2024-03-07 2024-03-07 Nystagmus electrical stimulation device and method of operation thereof Pending CN117839077A (en)

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