WO2021194102A1 - Système de stimulation à rétroaction basé sur un journal de mictions et son procédé de commande - Google Patents

Système de stimulation à rétroaction basé sur un journal de mictions et son procédé de commande Download PDF

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WO2021194102A1
WO2021194102A1 PCT/KR2021/002229 KR2021002229W WO2021194102A1 WO 2021194102 A1 WO2021194102 A1 WO 2021194102A1 KR 2021002229 W KR2021002229 W KR 2021002229W WO 2021194102 A1 WO2021194102 A1 WO 2021194102A1
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stimulation
urination
parameter
application
information
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PCT/KR2021/002229
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English (en)
Korean (ko)
Inventor
박은경
김태경
이규성
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사회복지법인 삼성생명공익재단
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Publication of WO2021194102A1 publication Critical patent/WO2021194102A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36132—Control systems using patient feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36146—Control systems specified by the stimulation parameters
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06N—COMPUTING ARRANGEMENTS BASED ON SPECIFIC COMPUTATIONAL MODELS
    • G06N20/00—Machine learning
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/30—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising

Definitions

  • the present invention relates to a voiding diary-based feedback stimulation system and method, and more particularly, to a neurostimulation system and a method for controlling the same for a patient-customized control based on a voiding diary record.
  • the electrode is a stimulation electrode that generates electrical stimulation by transmitting an electrical signal to the inside of the body, a measurement electrode that is mainly used to measure neural signal activity, and receives an electrical signal generated in the brain and transmits it to the outside.
  • a treatment method using such an electrode has been actively developed in recent years.
  • a treatment method using an electrode is being applied to a treatment method for nerve-related diseases.
  • implantable medical devices are frequently used to provide accurate nerve stimulation, and patients periodically There is a need to visit the hospital.
  • An object of the present invention is to provide a neurostimulation system capable of controlling patient-specific stimulation parameters, including software for recording, so as to change the stimulation at any time by analyzing the urination diary recorded daily or for a predetermined period in order to solve the above problems. .
  • the present invention provides, in the form of implantation or non-implantation, a stimulator which is located at a nerve site desired by a user and stimulates the nerve area according to a set stimulation parameter; and an application for calculating the stimulation parameter based on the urination information input by the user for a predetermined period and transmitting the stimulation parameter to the stimulation apparatus to control the operation of the stimulation apparatus. do.
  • the application may calculate the stimulation parameter by analyzing the urination information according to a preset classification criterion of a rule-base method.
  • the method may further include a server that receives and stores the urination information received from the application, calculates the stimulation parameter by analyzing the urination information using a machine learning technique, and transmits the stimulation parameter to the application.
  • the urination information may include at least one of urgency to urinate, feeling of residual urination, urination amount, urination frequency, water intake amount, and water intake frequency.
  • the stimulation parameter may include at least one of a stimulation intensity (mA), a stimulation frequency (Hz), a stimulation waveform (pulse), a stimulation period (ms), or a stimulation width (ms) for stimulating the nerve region may include
  • the present invention also provides a method for controlling a urination diary-based feedback stimulation system for stimulating a nerve part desired by a user with a stimulator according to a set stimulation parameter, wherein the urination information input by the user for a predetermined period is received from an application to do; calculating the stimulation parameters by analyzing the urination information in the application according to a preset classification criterion of a rule-base method or by analyzing the urination information by a machine learning technique in a server interworking with the application; and transmitting the stimulation parameters from the application to the stimulation apparatus to control the operation of the stimulation apparatus.
  • the method may further include setting an initial stimulation parameter according to urination information according to the user's condition or a stimulation site.
  • the calculating of the stimulation parameter may include at least one of urgency, residual urination, urination amount, urination frequency, water intake amount, or water intake number included in the urination information.
  • the machine learning technique may include: extracting urination information from pre-input clinical data and setting a criterion for a stimulation parameter corresponding to the urination information; and comparing the user's urination information with the reference and resetting the stimulation parameter.
  • the controlling of the driving of the stimulator may include a stimulation intensity (mA), a stimulation frequency (Hz), a stimulation waveform (pulse), and a stimulation period (ms) for stimulating the nerve region included in the stimulation parameter. Or it may include at least one of the stimulus width (ms).
  • the present invention having the configuration as described above, it is possible to optimize the effect of stimulation by changing the stimulation parameters so that a more optimized treatment can be provided to the patient in response to sudden pain or a change in the patient's condition through the feedback method. There is an advantage.
  • the present invention has the advantage of reducing the number of hospital visits and enabling home care by allowing the stimulation parameters to be changed without a hospital visit after surgery.
  • FIG. 1 is a block diagram of a urination diary-based feedback stimulation system of the present invention.
  • FIG. 2 is a detailed configuration and output screen of urination information and stimulation parameters according to an embodiment of the present invention.
  • FIG. 3 is a flowchart of a method for controlling a feedback stimulation system based on a urination diary of the present invention.
  • FIG. 4 is a detailed flowchart of FIG. 2 according to an embodiment of the present invention.
  • FIG. 5 is a flowchart of a machine learning technique of a server and an internal operation process according to an embodiment of the present invention.
  • FIG 6 shows another embodiment of the embodiment S31 of the present invention (S311).
  • FIG. 7 is a flowchart for calculating stimulation parameters according to an embodiment of the present invention.
  • FIG. 8 is a control method of a urination diary-based feedback stimulation system according to another embodiment of the present invention.
  • the present invention provides, in the form of implantation or non-implantation, a stimulator which is located at a nerve site desired by a user and stimulates the nerve area according to a set stimulation parameter; and an application for calculating the stimulation parameter based on the urination information input by the user for a predetermined period and transmitting the stimulation parameter to the stimulation apparatus to control the operation of the stimulation apparatus. do.
  • the application may calculate the stimulation parameter by analyzing the urination information according to a preset classification criterion of a rule-base method.
  • the method may further include a server that receives and stores the urination information received from the application, calculates the stimulation parameter by analyzing the urination information using a machine learning technique, and transmits the stimulation parameter to the application.
  • the urination information may include at least one of urgency to urinate, feeling of residual urination, urination amount, urination frequency, water intake amount, and water intake frequency.
  • the stimulation parameter may include at least one of a stimulation intensity (mA), a stimulation frequency (Hz), a stimulation waveform (pulse), a stimulation period (ms), or a stimulation width (ms) for stimulating the nerve region may include
  • the present invention also provides a method for controlling a urination diary-based feedback stimulation system for stimulating a nerve part desired by a user with a stimulator according to a set stimulation parameter, wherein the urination information input by the user for a predetermined period is received from an application to do; calculating the stimulation parameters by analyzing the urination information in the application according to a preset classification criterion of a rule-base method or by analyzing the urination information by a machine learning technique in a server interworking with the application; and transmitting the stimulation parameters from the application to the stimulation apparatus to control the operation of the stimulation apparatus.
  • the method may further include setting an initial stimulation parameter according to urination information according to the user's condition or a stimulation site.
  • the calculating of the stimulation parameter may include at least one of urgency, residual urination, urination amount, urination frequency, water intake amount, or water intake number included in the urination information.
  • the machine learning technique may include: extracting urination information from pre-input clinical data and setting a criterion for a stimulation parameter corresponding to the urination information; and comparing the user's urination information with the reference and resetting the stimulation parameter.
  • the controlling of the driving of the stimulator may include a stimulation intensity (mA), a stimulation frequency (Hz), a stimulation waveform (pulse), and a stimulation period (ms) for stimulating the nerve region included in the stimulation parameter. Or it may include at least one of the stimulus width (ms).
  • the present invention is a neurostimulation system including a program capable of controlling patient-specific stimulation parameters based on a urination diary record.
  • a patient may be used as the same meaning as a user.
  • FIG. 1 shows a configuration diagram of a urination diary-based feedback stimulation system 1 of the present invention.
  • the present invention may include a stimulation apparatus 10 , an application 20 , and a server 30 .
  • the server 30 may interwork with the application 20 , and may calculate the stimulation parameters by the application 20 itself, but may optionally calculate the stimulation parameters by interworking with the server 30 .
  • the stimulator 10 in the form of implantation or non-implantation, may be positioned at a nerve site desired by the user and may stimulate the nerve area according to set stimulation parameters.
  • the application 20 may calculate the stimulation parameter based on urination information input by the user for a predetermined period and transmit the stimulation parameter to the stimulation apparatus 10 to control the operation of the stimulation apparatus 10 .
  • FIG. 2 shows a detailed configuration and output screen of urination information and stimulation parameters according to an embodiment of the present invention.
  • stimulation parameters calculated according to urination information are shown.
  • the urination information may include at least one of urgency, residual urination, urination amount, urination frequency, water intake, or water intake, and according to an embodiment, urination information is calculated based on information input by the patient for a predetermined period of time. can do.
  • the stimulation parameter may include at least one of a stimulation intensity (mA), a stimulation frequency (Hz), a stimulation waveform (pulse), a stimulation period (ms), and a stimulation width (ms) for stimulating the nerve site.
  • a stimulation intensity mA
  • Hz stimulation frequency
  • pulse stimulation waveform
  • ms stimulation period
  • ms stimulation width
  • a stimulator 10 that actually stimulates nerves is used, and in order to control it, the feedback stimulation system 1 may be driven by an application 20 that receives and controls a patient's condition.
  • the stimulator 10 proceeds with nerve stimulation with basic stimulation parameters while being inserted into the human body.
  • the application 20 receives a signal to change the stimulation parameter or receives the changed stimulation parameter, the nerve is stimulated with the changed stimulation parameter. stimulation can proceed.
  • the user inserts the stimulator 10 into the body and receives the initial stimulation, and through the application 20 that records the urination diary every day, wake up time, bedtime, urination time, urination amount, residual urination, urgency, water intake time, or Urination information including water intake may be input, and current stimulation parameter values may be checked and changed through the application 20 .
  • the intensity of stimulation may be adjusted through the urination log application 20 .
  • the application 20 may store data and calculate stimulation parameters with a device such as a mobile phone or a pad, and may be configured to interwork with the external server 30 if necessary.
  • the application 20 may calculate the stimulation parameter by analyzing the urination information according to a preset classification criterion of a rule-base method.
  • the server 30 may be selectively used, and according to an embodiment, when the server 30 is linked, the server 30 receives and stores the urination information received from the application 20, and stores the urination information. can be analyzed by a machine learning technique to calculate the stimulation parameter and transmit the stimulation parameter to the application 20 .
  • the server 30 may convert the urination information received from the urination diary application 20 into big data and calculate the optimal stimulation parameter for the patient using a machine learning technique.
  • the stimulation parameter can be calculated as a standard in the application 20 itself as a basic rule base method, or the stimulation parameter can be calculated by using a machine learning technique in conjunction with the server 30. .
  • the appropriate stimulation parameter is extracted and stimulation is performed, and the stimulation parameter can be continuously modified based on the urination information received from the application 20 .
  • the application 20 transmits the stimulation parameters received from the server 30 to the stimulator 10 , and the stimulator 10 may stimulate nerves through the changed stimulation parameters.
  • FIG. 3 is a flowchart of a method for controlling a feedback stimulation system based on a urination diary of the present invention.
  • the method of controlling the feedback stimulation system includes the steps of setting initial stimulation parameters (S10), receiving urination information from an application (S20), calculating the stimulation parameters (S30), and driving the stimulator. It may include a step (S30) of controlling the.
  • the step of setting the initial stimulation parameter is a process of setting an initial value according to the urination information according to the user's condition or the stimulation site. After inserting the stimulator according to the stimulator insertion sequence, power is applied to the stimulator to perform pairing with the application and initialization process. In this case, initial stimulation parameter setting, patient registration, and communication connection can be performed.
  • the stimulator may perform stimulation with the set initial stimulation parameters, and may go through a process of resetting stimulation parameters by uploading a urination diary to the application for a predetermined period of time.
  • the step of receiving the urination information from the application (S20) is a process of loading the urination information input by the user for a predetermined period.
  • the predetermined period may be 24 hours, and when there is a sudden change in the body, the time may be adjusted.
  • the step of calculating the stimulation parameter (S30) is to analyze the urination information in the application according to a preset classification criterion of a rule-base method or to analyze and calculate the urination information in a server interworking with the application using a machine learning technique. It is a process.
  • the rule-base method does not analyze the input urination information, but compares it with the standard set in the application, and applies the stimulation parameters directly to the stimulator according to the standard. It is a process of calculating stimulation parameters based on analyzed clinical data. This will be described later.
  • the step of controlling the driving of the stimulation apparatus is a process of driving the stimulation apparatus by transmitting the stimulation parameters to the stimulation apparatus in an application.
  • the changed stimulation parameter may be transmitted, and a method of applying a change signal to the stimulation parameter to be changed to the stimulation apparatus may also be used.
  • FIG. 4 is a detailed flowchart of FIG. 3 according to an embodiment of the present invention.
  • steps S10 and S20 are the same as those of FIG. 3, a process in which an operation method is changed according to the presence or absence of an external server is added to step S30, and a process in which a user directly inputs stimulation parameters is further added to step S40 Included.
  • step S30 when an external server is linked, the server may go through a process of analyzing using machine learning techniques (S31), and without an external server, the stimulation parameter may be directly changed in the application according to the rule base (S32) .
  • step S30 is divided into step S31 and step S32, and will be described with reference to FIGS. 5 ( S31 ) and 6 ( S32 ), respectively, and step S40 will be described.
  • FIG. 5 shows a flowchart of a machine learning technique of a server and an internal operation process according to an embodiment of the present invention (S31).
  • the server may receive existing clinical data and extract only urination information.
  • the server matches the user's urination information with the stimulation parameter that the user feels optimally and converts it into big data. Thereafter, the urination information input from the application is analyzed based on the urination diary, and the stimulation parameters can be calculated by comparing the urination information with the existing big data according to the input urination information.
  • the machine learning technique includes a process of extracting urination information from previously input clinical data and setting a criterion for a stimulation parameter corresponding to the urination information; and comparing the user's urination information with the reference and resetting the stimulation parameter.
  • the machine learning method based on the input data such as the amount of urination according to the amount of water ingested, the confirmation of nocturia and frequency according to the urination time, the amount of urination and the interval between urination, and the feeling of residual urination and the urgency of the patient, the kinematic, temporal, and machine learning-based It may further include a process of identifying a characteristic and the like.
  • the process of making big data includes calculating the correlation with the stimulation parameters based on age, weight, urination disorder, and the above-mentioned urination information.
  • the big data is not limited to the above, and may include all information related to urination.
  • FIG 6 shows another embodiment of the embodiment S31 of the present invention (S311).
  • the change of the stimulation parameter may be changed on a clinical basis as in S31, but may be changed by the compensation value (R) and the change rule (W) by adding the changed parameter according to the state.
  • Patient status (S) ⁇ average voiding volume, frequency of urination, residual urination, urinary urgency, diuresis, total intake, intake interval, stimulation pain ⁇
  • Stimulation parameters (A) ⁇ stimulus intensity, stimulus frequency, stimulus waveform, stimulus cycle, stimulus width ⁇
  • parameter change is performed according to the confirmed patient's condition (S).
  • Value (y) evaluation is performed on the parameter change rule (W) using the compensation value (R).
  • the parameter change rule is updated according to the learning rate (l).
  • P, Q, and W may each be a simple function or a machine learning model, and each may be configured as shown in Table 1 below in three different configurations of normal, mild, and severe according to S, and each can be classified according to the amount of urination, frequency of urination, feeling of residual urination, and urgency.
  • Urination volume ⁇ 150 100-150 ⁇ 100 Number of urination (times) ⁇ 8 8-12 >12 Residual urination (dots) ⁇ 2 2-3 >3 Urgency (point) ⁇ 2 2-3 >3
  • FIG. 7 is a flowchart of calculating a stimulation parameter (S32) according to an embodiment of the present invention.
  • the stimulation parameter is calculated based on the application itself. According to an embodiment, it is analyzed whether the current stimulus is painful. After that, each parameter is compared and the stimulation parameter is changed.
  • 'Is the urgency score 3 points or more?', 'Is the residual urination score 3 points or more?', 'Is the amount of urination less than 150ml?', 'The number of urinations per day is It can be changed by judging the occurrence of disease-specific abnormal patterns based on clinically used indicators such as 'is it more than 8 times?'
  • the present invention is not limited thereto, and may include criteria that may be implemented in the application itself.
  • step S40 at least one of a stimulation intensity (mA), a stimulation frequency (Hz), a stimulation waveform (pulse), a stimulation period (ms), or a stimulation width (ms) that stimulates a nerve region included in the stimulation parameter It is the process of controlling the stimulator, including
  • FIG. 8 is a diagram illustrating a method for controlling a feedback stimulation system based on a urination diary according to another embodiment of the present invention.
  • a hardware configuration diagram and a software configuration diagram may be identified according to the interworking of the server according to the other embodiments of FIGS. 5 and 6 described above.
  • the hardware configuration diagram shows the difference in interworking with external servers centered on the application, and the software configuration diagram shows the process of deriving big data and optimal stimulation parameters from the server as the server is included.
  • the present invention includes a feedback stimulation system capable of controlling patient-specific stimulation parameters including software for recording a urination diary recorded every day.

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Abstract

La présente invention concerne un système de stimulation à rétroaction basé sur un journal de mictions et un procédé associé, ainsi que : un système de stimulation neurale qui permet de réaliser une commande de paramètres de stimulation personnalisée pour le patient et qui comprend l'enregistrement d'un logiciel susceptible d'analyser un journal de mictions, qui est rempli quotidiennement ou pendant une période de temps prédéfinie, et la variation de manière fréquente de la stimulation ; et son procédé de commande, les paramètres de stimulation étant calculés par l'analyse d'informations de mictions, saisies par un utilisateur, dans un mode à base de règles ou au moyen d'une technique d'apprentissage automatique.
PCT/KR2021/002229 2020-03-26 2021-02-23 Système de stimulation à rétroaction basé sur un journal de mictions et son procédé de commande WO2021194102A1 (fr)

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KR1020200036857A KR102368615B1 (ko) 2020-03-26 2020-03-26 배뇨일지 기반의 피드백 자극 시스템 및 그 제어 방법
KR10-2020-0036857 2020-03-26

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KR101620139B1 (ko) * 2013-07-22 2016-05-12 한국전자통신연구원 전기 자극 시스템 및 전기 자극 시스템의 제어 방법

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US20060190049A1 (en) * 2005-02-23 2006-08-24 Medtronic, Inc. Implantable medical device providing adaptive neurostimulation therapy for incontinence
KR20140098780A (ko) * 2011-11-11 2014-08-08 뉴로이네이블링 테크놀로지스, 인크. 운동, 감각, 자율적, 성적, 혈관운동 및 인식 기능의 복원을 가능하게 하기 위한 비침습성 신경조절 디바이스
JP2019531149A (ja) * 2016-10-14 2019-10-31 ボストン サイエンティフィック ニューロモデュレイション コーポレイション 電気刺激システムに対する刺激パラメータ設定の閉ループ決定のためのシステム及び方法
KR20190108350A (ko) * 2018-03-14 2019-09-24 이화여자대학교 산학협력단 비침습적 방광 배뇨 관리 시스템

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