HK1245611B - Dysphagia test device, dysphagia test method, dysphagia treatment device, and stimulating current setting method - Google Patents

Description

Swallowing disorder examination device, swallowing disorder examination method, swallowing disorder treatment device, and stimulation current setting method

Technical Field

The present invention relates to a dysphagia inspection device and a dysphagia inspection method suitable for dysphagia inspection, and a dysphagia treatment device and a stimulation current setting method suitable for dysphagia treatment.

Background Art

Swallowing is the process of swallowing food and moving it to the stomach. It occurs through a complex series of movements in the mouth, larynx, and esophagus. Dysphagia refers to a condition where some part of this process is impaired. Dysphagia includes the accidental swallowing of food into the trachea rather than the esophagus.

Dysphagia can be caused by various diseases. Examples of diseases that can cause dysphagia include stroke, brain trauma, cerebral palsy, dementia, Parkinson's disease, Huntington's disease, Wilson's disease, amyotrophic lateral sclerosis (ALS), multiple sclerosis, brain tumors, and myasthenia gravis.

As a treatment for dysphagia, the inventors of this case and others have previously provided a method of percutaneously stimulating the superior laryngeal nerve with interference waves (Patent Document 1). In this method, two or more pairs of electrodes are prepared, each pairing a positive pole and a negative pole. By means of a control unit, an electric current of a predetermined frequency (carrier frequency) from the electrodes flows percutaneously to the pharynx. At this time, the frequency difference (therapeutic frequency) between the electrodes is adjusted to 10 to 100 Hz. Furthermore, the output is performed from the paired electrodes for 1 to 1000 ms, and the output is stopped for 1 to 1000 ms. This action is performed continuously and interactively.

In addition to treatment methods, the inventors of this case also provide various techniques for monitoring swallowing activity (Patent Documents 2 and 3). For example, in the swallowing activity monitoring device described in Patent Document 2, suprasternal fossa pressure information based on the subject's suprasternal fossa movement is read from a storage medium. Furthermore, respiratory flow information based on the subject's respiratory activity is read from the storage medium. The subject's swallowing activity is then detected based on the read suprasternal fossa pressure and respiratory flow information.

The swallowing estimation device described in Patent Document 3 includes a sound sensor for detecting laryngeal sounds, a pressure sensor for detecting respiration, and a control unit for estimating swallowing based on biosound data based on a sound signal output from the sound sensor and airflow pressure data based on a pressure signal output from the pressure sensor. The control unit acquires a parameter value for estimating swallowing for a biosound generation interval corresponding to an apneic interval of 400 msec or longer, and estimates whether swallowing has occurred during the biosound generation interval based on whether the acquired parameter value satisfies a swallowing determination condition.

[Prior art literature]

[Patent Document]

[Patent Document 1] Japanese Patent Application Laid-Open No. 2007-151736

[Patent Document 2] Japanese Patent Publication No. 2009-151324

[Patent Document 3] International Publication No. WO15/029501.

Summary of the Invention

(Problems to be solved by the invention)

In the diagnosis and treatment of swallowing, it is desirable to be able to simply and appropriately determine the presence and degree of dysphagia, and the degree of improvement of dysphagia through swallowing treatment, and it is desirable to be able to more effectively advance the treatment of dysphagia.

The purpose of the present invention is to provide a swallowing disorder examination device and a swallowing disorder examination method that can simply and appropriately determine the presence, degree of the disorder and the degree of improvement of swallowing disorders, as well as a swallowing disorder treatment device and a stimulation current setting method that can perform appropriate treatment according to the degree of the disorder.

(Methods for solving the problem)

One aspect of the present invention uses the sensory threshold obtained through transcutaneous stimulation with interfering waves or simulated interfering waves as an evaluation indicator to assess dysphagia in a patient. Here, the sensory threshold refers to the current threshold at which the patient can perceive the stimulation of a weak current flowing through the tissue of the neck containing the superior laryngeal nerve in order to provide transcutaneous stimulation with the interfering waves or simulated interfering waves.

In this aspect, the dysphagia assessment may provide at least one of the presence or absence of dysphagia, the degree of dysphagia, and the degree of improvement in dysphagia treatment.

In addition, in order to obtain the sensory threshold, a pair or more pairs of positive and negative electrodes can be set on the neck, the frequency of the current imparted by the electrodes can be set to 500 to 800 Hz, and the frequency difference between the electrodes can be set to 10 to 100 Hz, so as to impart stimulation caused by interference waves or simulated interference waves to the person being treated.

In this case, the paired electrodes are preferably attached to the neck in parallel or in an X-shape, and are preferably thin and flexible.

In addition, the output of stimulation can be specified as a sensory threshold, which is a value at which the subject can consciously feel the stimulation, in the range of 0 to 10 mA (effective value of a load resistor of 500Ω).

At this time, the sensory threshold values specified are recorded and saved in real time, and the saved data can be retrieved at a required time point, and the retrieved data can be compared with initial data, historical data, cumulative average data or known dysphagia data.

The swallowing disorder examination device described in this aspect comprises: a current imparting unit, which is attached to the target part of the treated person in order to percutaneously impart current to the biological tissue of the neck containing the superior laryngeal nerve; a control unit, which controls the current imparting unit so that percutaneous stimulation caused by an interference wave or a simulated interference wave is imparted to the biological tissue; an operating unit, which is used to adjust the current imparted by the current imparting unit to a sensory threshold at which the treated person is aware of the percutaneous stimulation; and a display unit, which displays pointer information obtained based on the sensory threshold.

In addition, the swallowing disorder examination method described above includes: a step of applying current percutaneously from an electrode attached to the neck of the treated person to apply percutaneous stimulation caused by an interference wave or a simulated interference wave to the biological tissue of the neck containing the superior laryngeal nerve; a step of obtaining the current threshold at which the treated person perceives the stimulation; and a step of displaying information obtained based on the obtained current threshold as an evaluation indicator of swallowing disorder.

With the dysphagia testing device and method thus constructed, pointer information based on the sensory threshold of the patient's perceived transcutaneous stimulation is displayed as an evaluation indicator of dysphagia. Therefore, the operator can assess the patient's dysphagia status based on the output pointer information.

Another aspect of the present invention is that, in the treatment of dysphagia, the sensory threshold value obtained by the above method may be used to set transcutaneous stimulation caused by interference waves or simulated interference waves. In this aspect, when transcutaneous stimulation caused by interference waves or simulated interference waves is continuously or intermittently applied to cervical tissue containing the superior laryngeal nerve during treatment, the sensory threshold value obtained by the above method can be used as an indicator for setting individual optimal stimulation conditions for each patient.

In this aspect, transcutaneous stimulation caused by interference waves or simulated interference waves for treating swallowing disorders can be achieved, for example, by providing a pair or more pairs of electrodes with positive and negative electrodes on the neck, setting the frequency of the current imparted by the electrodes to 500 to 8000 Hz, and setting the frequency difference between the electrodes to 10 to 100 Hz, and further by continuously or intermittently outputting current from the electrodes for 10 minutes to 8 hours.

At this time, the interfering can be interrupted by, for example, repeating a process of applying an interfering wave for 0.05 to 5 seconds and a process of applying a non-interfering wave for 0.05 to 5 seconds for 10 minutes to 8 hours.

Furthermore, the conditions for intermittently outputting current from the electrode can be set to alternately continuously output current for 0.05 to 5 seconds and stop outputting current for 0.05 to 5 seconds.

The dysphagia treatment device described in this aspect includes: a current applying unit attached to a target area of a patient for transcutaneously applying current to body tissue in the neck, including the superior laryngeal nerve; a control unit for controlling the current applying unit so as to apply transcutaneous stimulation to the body tissue using an interference wave or a simulated interference wave; and an operating unit for adjusting the current applied by the current applying unit to a sensory threshold at which the patient perceives the transcutaneous stimulation. The control unit sets the current value used to treat the patient to the current applying unit based on the sensory threshold adjusted via the operating unit.

In addition, the stimulation current setting method described above includes: a step of imparting current percutaneously from an electrode attached to the neck of the treated person, thereby imparting percutaneous stimulation caused by an interference wave or a simulated interference wave to the biological tissue of the neck containing the superior laryngeal nerve; a step of obtaining the current threshold at which the treated person perceives the stimulation; and a step of outputting current from the electrode according to the set current value.

With the dysphagia treatment device and stimulation current setting method thus constructed, the current value used for treatment is adjusted according to the degree of dysphagia experienced by the patient. Therefore, stimulation appropriate to the degree of dysphagia experienced by the patient can be transcutaneously delivered to the cervical tissue containing the patient's superior laryngeal nerve, effectively promoting dysphagia treatment.

Moreover, the so-called "transcutaneous application of electric current to the cervical biological tissue containing the superior laryngeal nerve" in various aspects of the present invention not only includes applying electric current to the superior laryngeal nerve of the neck, but also broadly includes applying electric current to the superior laryngeal nerve of the neck and the nerves surrounding it, such as the glossopharyngeal nerve, trigeminal nerve, and muscles.

[Effects of the Invention]

As described, the present invention can provide a swallowing disorder examination device and a swallowing disorder examination method that can simply and appropriately determine the presence, degree of the disorder, and degree of improvement of swallowing disorders. In addition, it can provide a swallowing disorder treatment device and a stimulation current setting method that can perform appropriate treatment based on the degree of the disorder.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a graph showing the measurement results of the distribution of sensory thresholds of healthy subjects in the embodiment.

FIG. 2 is a graph showing measurement results when stimulation by interference waves is applied to the subject 1 and the sensory threshold of the subject 1 is measured every day in the embodiment.

FIG. 3 is a graph showing measurement results when stimulation by interference waves is applied to the subject 2 and the sensory threshold of the subject 2 is measured every day in the embodiment.

FIG. 4 is a graph showing measurement results when stimulation by interference waves was applied to the subject 3 and the sensory threshold of the subject 3 was measured at intervals of three days in the embodiment.

FIG. 5 is a graph showing measurement results when stimulation by interference waves was applied to the subject 4 and the sensory threshold of the subject 4 was measured at intervals of three days in the embodiment.

Figure 6(a) is a diagram showing the external structure of the dysphagia treatment device installed on a patient in accordance with the embodiment. Figure 6(b) is a perspective view showing the treatment device body with a charger installed in accordance with the embodiment.

FIG7 is a block diagram showing the structure of the therapeutic device body in the embodiment.

Fig. 8(a) schematically shows the waveform of the voltage applied from the electrodes in the embodiment. Fig. 8(b) schematically shows the effect of the dysphagia treatment device in the embodiment.

Fig. 9(a) is a flow chart of the setting process of the treatment current value in the display embodiment. Fig. 9(b) is a diagram showing the screen structure of the display unit and the operation unit structure of the treatment device body in the display embodiment.

Figures 10(a) and (b) schematically show the changes in electrode output level when the UP key and DOWN key are operated, respectively, in accordance with the embodiment. Figure 10(c) schematically shows the time chart of the changes in the treatment current value until the treatment current value is set, in accordance with the embodiment.

Fig. 11(a) is a flowchart of a display process of history information in the display embodiment. Fig. 11(b) is a diagram showing an example of display of history information in the display embodiment.

FIG12(a) is a flowchart of the mode (MOLD) setting process in display modification example 1. FIG12(b) is a flowchart of the treatment current value setting process in display modification example 1. FIG12(c) is a flowchart of the treatment current value setting process in display modification example 2.

13(a) and (b) show the screen configuration of the display unit and the configuration of the operation unit displayed on the treatment device body in other modified examples.

Fig. 14(a) is a diagram showing the screen structure of the display unit and the structure of the operation unit of the treatment device in another modification. Fig. 14(b) and (c) are flow charts showing the control in this modification.

Fig. 15(a) is a diagram showing the screen structure of the display unit and the structure of the operation unit of the treatment device in another modification. Fig. 15(b) is a flow chart showing the control in this modification.

However, the drawings are intended to be illustrative only and not limiting of the scope of the invention.

DETAILED DESCRIPTION

1. Examination methods for dysphagia

One embodiment of the present invention utilizes the sensory threshold obtained by applying stimulation of a transcutaneous interferential wave or a simulated interferential wave as a marker for evaluating dysphagia, which can be used as a method for examining dysphagia.

Here, the sensory threshold used as a marker for dysphagia assessment refers to the minimum current value that a patient can perceive as stimulation by a weak electric current flowing transcutaneously through the neck for several seconds. In other words, it is the current threshold at which somatosensory nerves perceive the current. For example, the sensory threshold is measured as follows.

First, a doctor or other operator attaches an electrode to the patient's neck, and then drives a stimulation device (which may be the dysphagia treatment device itself) that imparts stimulation caused by interference waves or simulated interference waves through the electrode, so that a weak current is output from the electrode. Next, the operator gradually increases the output of the weak current, and asks the patient to report the point at which the patient is aware of the stimulation from the weak current, and the current value at this point is measured as the sensory threshold. The current value is measured, for example, by setting an ammeter on the electrode line of the stimulation device. In addition, based on the input indicating that the patient is aware of the stimulation, a system that displays the current value at this time can be used.

When the stimulation device is equipped with a current value measurement function, the operator, as described above, attaches electrodes to the patient's neck, drives the stimulation device (device for treating dysphagia), and gradually increases the output. The operator asks the patient to report the time when the patient is aware of the stimulation from the weak current, and inputs the stimulation device to fix and/or record the current output level at this time. In this way, the stimulation device measures the current value at this time by means of the current detection/display function pre-installed inside, and sets the measured current value as the sensory threshold. That is, when the patient is aware of the weak current, the operator automatically records and saves the current value as data in the stimulation device by inputting the current output level fixation. The measured value can be confirmed by calling the current value saved as data. This measured value is the sensory threshold. Here, the input for fixing the current value is not limited to the operator, but can also be made by the patient.

For example, when imparting stimulation caused by an interference wave in order to obtain a sensory threshold, two pairs of electrodes with a positive pole and a negative pole are set on the neck. In addition, in order to obtain a sensory threshold and impart a stimulation value caused by a simulated interference wave, a pair of electrodes with a positive pole and a negative pole are set on the neck. The frequency of the current imparted by the electrodes is set to 500 to 8000 Hz and the frequency difference between the electrodes is set to 10 to 100 Hz as treatment for the person being treated. The stimulation targets the biological tissue of the meridian part containing the superior laryngeal nerve, that is, the superior laryngeal nerve and its peripheral nerves and muscles (hereinafter referred to as "superior laryngeal nerve, etc."). Moreover, the electrodes are preferably attached to the neck in pairs in parallel or in an X-shape. In addition, it is preferred to use thin and flexible electrodes.

Transcutaneous stimulation using interference waves or simulated interference waves is performed with an output of 0 to 10 mA (effective value when connected to a 500Ω load resistor). The threshold at which the patient can perceive the stimulation is specified. The output rise can be automatic or non-automatic, with a ramp or step-by-step pattern. The patient's threshold is stored as data using a unit that specifies and determines the threshold. The threshold is expressed, for example, in mA (milliamperes).

The inventors of this case have actually measured that the average sensory threshold of 81 healthy adults is 1.05 mA (for example, also called cumulative average data). On the other hand, after measuring the laryngeal elevation delay time (LEDT) evaluated by the known degree of dysphagia (for example, also called known dysphagia data) for patients specifically designated as dysphagic patients, the patients showed a sensory threshold of more than 2.5 mA. In the embodiments described later, during the interferential wave stimulation treatment of dysphagic patients, both the sensory threshold and the LEDT were measured, and their correlation was confirmed. As a result, it was confirmed that the value of the sensory threshold is related to the degree of dysphagia. Therefore, a dysphagia examination method using the sensory threshold as a marker for dysphagia examination was successfully provided.

The presence or absence of swallowing disorders can be determined based on the average sensory threshold of healthy adults (for example, about 1.05 mA), taking into account individual differences up to a value of 2.5 mA. In this case, the higher the sensory threshold, the higher the possibility of swallowing disorders. In the degree of determination of the degree of difficulty in swallowing disorders, the higher the sensory threshold, the higher the degree of difficulty in swallowing disorders may be. In the degree of determination of the degree of improvement in the treatment of swallowing disorders, the lower the sensory threshold measured during treatment is relative to the initial sensory threshold, the higher the degree of improvement in the treatment of swallowing disorders may be.

The method for measuring the sensory threshold by using a stimulation device (which may also be a dysphagia treatment device, the same applies hereinafter) caused by interference waves or simulated interference waves is as follows.

The stimulation device may be equipped with a circuit for measuring the current during treatment, with a built-in ammeter measuring the current value of the sensory threshold and displaying the output level on the device's display. Furthermore, the device may be equipped with a component or medium for recording and storing data, recording and storing the measured sensory threshold current value as sensory threshold data in the device's main body, and calling up the stored sensory threshold current value as data by operating the device for display on the main body's display.

Furthermore, in the device, a plurality of measured current values can be recorded and stored as data. The device can record, store, and output the measured current value of the sensory threshold as historical data. Operators such as doctors can also sequentially call out the historical data of the recorded current value of the sensory threshold by operating the device. In this way, the operator can call out and confirm the current value of the past sensory threshold, and by comparing it with the baseline value of the sensory threshold of dysphagia (for example, the data of the embodiment described later is about 2.5 mA as the baseline), it can be determined whether the patient has dysphagia. Furthermore, the operator can confirm the degree of treatment of dysphagia by confirming the current values of the multiple past sensory thresholds recorded in the device.

2. Method for Setting Stimulation Conditions for Dysphagia Treatment

Another embodiment of the present invention uses the obtained sensory threshold as a reference, and in a dysphagia treatment device, it is possible to master the setting of the optimal stimulation conditions (individual optimal interference wave stimulation conditions) for each patient as a setting method. In addition, based on the set optimal conditions, it is possible to master the operation of the dysphagia treatment device as a treatment method. Here, in order to treat dysphagia, the superior laryngeal nerve is transcutaneously stimulated by interference waves or simulated interference waves. The power output is performed continuously or intermittently, so that the interference is continuous or intermittent. The operation of the dysphagia treatment device can be linked to the setting of the optimal conditions, or can be carried out independently of this.

The optimal interference wave stimulation condition for an individual is set using the sensory threshold as a marker. The sensory threshold of the individual (patient) is continuously recorded and stored as historical data from the start of dysphagia treatment as the treatment progresses.

When the initial sensory threshold data is specifically specified, the pre-set initial optimal interference wave stimulation conditions (carrier frequency, treatment frequency, processing output, output mode, output time, etc.) are selected based on the initial sensory threshold and the patient's age, gender, etc., forming the initial individual optimal interference wave stimulation condition settings. This setting allows the operating conditions of the dysphagia treatment device corresponding to each of the set condition values to be specifically specified as either linked or non-linked, and the dysphagia treatment device is operated using these specifically specified operating conditions.

When the sensory threshold fluctuates according to treatment, the pre-set optimal interference wave stimulation conditions (carrier frequency, treatment frequency, processing output, output embodiment, output time, etc.) are selected based on basic information (initial sensory threshold, age, gender, etc.) and the fluctuating sensory threshold, forming the individual optimal interference wave stimulation condition settings. This setting allows the operating conditions of the dysphagia treatment device corresponding to each value of the set condition to be specifically designated as linked or non-linked, thereby changing the operating conditions of the dysphagia treatment device to those based on the fluctuation in the sensory threshold. The dysphagia treatment device operates under these modified operating conditions.

To select the optimal interferential wave stimulation conditions for an individual, a unit for controlling the degree of stimulation caused by interferential waves used in dysphagia treatment can be selected. Specifically, the stimulation conditions caused by interferential waves or simulated interferential waves are specified using one or more pairs of positive and negative electrodes placed on the neck, with the frequency of the current applied by these electrodes set to 500 to 8000 Hz, and the frequency difference between these electrodes set to 10 to 100 Hz. Furthermore, the output from these electrodes is continuous or intermittent for 10 minutes to 8 hours.

The stimulation caused by interfering waves is less painful and uncomfortable on the skin, and low-frequency waves can reach deep into the skin. For example, when using medium-frequency waves of 2000Hz and 2050Hz for transcutaneous electrical stimulation, a low-frequency wave of 50Hz is generated deep beneath the skin. The medium-frequency used for stimulation is called the carrier frequency, and the low-frequency generated is called the difference frequency (therapeutic frequency).

The carrier frequency is desirably 500 to 8000 Hz, preferably 1000 to 4000 Hz, and more preferably 1500 to 3000 Hz. This is because, with currents at frequencies lower than 500 Hz, subcutaneous pain receptors react more strongly, transmitting pain sensation to the central nervous system. With currents at frequencies higher than 8000 Hz, muscle contraction cannot follow individual stimulation pulses, and the muscles remain in a state of continuous contraction while the current is applied.

The difference frequency, or the frequency used to treat dysphagia, is selected from a range of 10 to 100 Hz, preferably 20 to 80 Hz, and more preferably 30 to 60 Hz. The treatment frequency range of 10 to 100 Hz is chosen because this frequency band stimulates the receptors most relevant to dysphagia treatment, making it the most effective band for stimulating the superior laryngeal nerve.

Regarding the stimulation caused by interference waves for the treatment of dysphagia, there is a method of intermittently outputting interference as one of the methods of treating the interference waves. This method is a method of repeatedly outputting interference waves for 0.05 to 5 seconds and non-interference waves for 0.05 to 5 seconds, and continuously outputting them for 10 minutes to 8 hours. Another preferred treatment method is a method of only outputting interference waves or simulated interference waves intermittently. This method is a method of alternately and continuously performing the treatment of outputting interference waves for 0.05 to 5 seconds and the treatment of stopping the output of interference waves for 0.05 to 5 seconds. In addition, another preferred treatment method is a method of continuously outputting interference waves for 10 minutes to 8 hours. The number of treatment times for a patient by any method is 1 to several times a day, and the treatment period is 1 to 2 days or more. Treatment embodiments may be alternate-day treatment, daily treatment, and/or continuous treatment, which may be appropriately selected from the above.

For stimulation caused by interference waves used in dysphagia treatment, the current output from the paired electrodes is set between 1 and 10 mA (effective value when connected to a 500Ω load resistor). This value can be set in conjunction with or without specifying the sensory threshold.

One or two pairs of positive and negative electrodes can be attached centered on the thyroid cartilage. The electrodes can be no larger or smaller than necessary, and should not cause discomfort to the patient when attached. They are thin and flexible, providing excellent adhesion to the skin. If the patient experiences discomfort with the electrodes, prolonged use may be affected. Furthermore, if the adhesion of the electrodes is poor, or if the adhesion of the two or four electrodes combined is uneven, the resistance through the skin becomes uneven, potentially preventing the intended current from flowing through the skin.

Within the various conditions described above, specific conditions for dysphagia treatment, such as carrier frequency, treatment frequency, processing output, output example, and output time, are recorded and stored as data in the dysphagia treatment device. The dysphagia treatment device can link sensory threshold data before treatment with sensory threshold data after treatment (next measurement) to set optimal conditions for treatment.

3. Device

One embodiment of the device of the present invention is a device for swallowing disorder examination, which is equipped with at least a unit for imparting transcutaneous stimulation by means of interference waves or simulated interference waves. The device described in this embodiment has the function of obtaining the sensory threshold of an individual (patient) by using a stimulation device of this unit, recording and saving the obtained sensory threshold as data, and the saved data can be called out when needed. The details of the functions are applicable to the specifically specified contents in the swallowing disorder examination method. Preferably, the device described in one embodiment has the function of making the output of the stimulation rise automatically or non-automatically, inclined or in stages.

Another embodiment of the present invention has the function of serving as a device for performing dysphagia examination, and also has a unit for obtaining setting values of individual optimal stimulation conditions for each patient based on the sensory threshold obtained through the examination, and making dysphagia treatment possible based on the obtained setting values.

The device used for dysphagia testing can be a standalone device. Furthermore, this device can have a function for setting stimulation conditions using interference waves or simulated interference waves that are optimal for each individual (patient) for dysphagia treatment. Furthermore, this device can also be a dysphagia treatment device that also has a dysphagia treatment function using stimulation using interference waves or simulated interference waves.

A dysphagia treatment device with such complex functions is a unit that specifically specifies a sensory threshold for each patient, records and stores the specifically specified sensory threshold as data, and reads the sensory threshold data stored as data and specifically specifies the output conditions of the optimal stimulation for the patient (individual optimal stimulation output conditions). As necessary, the dysphagia treatment device can be operated in a linked or non-linked manner based on the specifically specified individual optimal stimulation output conditions.

Other embodiments of the present invention are units related to the swallowing disorder examination method, which, if necessary, can be further attached to a swallowing disorder treatment device together with a unit for specifying the optimal stimulation output conditions for an individual. The swallowing disorder treatment device itself can have a unit for confirming the sensory threshold. In this case, the following units can be selected as: a unit for confirming the stimulation output current value, such as an ammeter; a unit for confirming the stimulation by the subject, such as a unit that records and stores the current value as data on the subject's sensory threshold at that point in time when the subject feels a weak interference wave current; a unit that reads and displays the recorded and stored data over time and individually; a unit that specifies the optimal interference wave stimulation conditions for the individual in the future based on the correlation between the data obtained in the current examination and historical data, if necessary, statistical data, and data from known swallowing disorder examination units; and a unit that selects a treatment method for the current level of swallowing disorder based on multiple interference wave treatment methods, etc., and can be attached to the swallowing disorder treatment device. The swallowing disorder treatment device can be adjusted to operate in a linked or non-linked manner based on the specifically specified individual optimal interference wave stimulation conditions. Linked means that a series of actions are linked to data analysis and then incorporated into device operation. Non-linked means that device operation and data analysis are not integrated.

The system or device for the inspection and treatment of dysphagia is at least equipped with a unit that records and stores the sensory threshold at which the patient can consciously feel the stimulation due to stimulation when in use. Here, the stored data can be called up and displayed over time and compared with the historical stored data and numerical values. The numerical value used for this comparison is displayed and used as a mark of the progress and/or improvement of the degree of dysphagia. Furthermore, based on this numerical value, the individual optimal interference wave stimulation condition is set for each patient. With such a structure, a system or device for the inspection and treatment of dysphagia caused by interference waves or simulated interference waves is provided.

[Example]

<Verification>

The following describes an experiment conducted to confirm the effectiveness of the above method. The experiment was conducted under the following conditions.

The sensory threshold of interference waves was confirmed for each subject. The subjects were healthy subjects without dysphagia and patients with dysphagia.

Two pairs of electrodes, each with a positive and negative electrode, were placed on the neck of the subject in a cross pattern. Similarly, there is also a method of placing a pair of electrodes, and the experiment was conducted.

Interference waves of 2000Hz and 2050Hz were applied to the subjects, and the treatment frequency (difference frequency) was adjusted to 50Hz. A device capable of adjusting the voltage from 0V to 10V in 10 to 100 steps was used for interferential wave stimulation. The lowest current intensity at which each subject could perceive the stimulation from the device was recorded as the sensory threshold.

To confirm the correlation between sensory threshold and the degree of dysphagia, a known method for assessing (determining) dysphagia improvement was used. In this study, the dysphagia status of dysphagia patients whose sensory thresholds were monitored was assessed based on the results of the delayed laryngeal elevation time (LEDT), an analytical parameter of radiographic animations obtained from swallowing imaging studies.

A swallowing imaging test uses X-ray fluoroscopy to assess swallowing (swallowing) function. The patient sits in a wheelchair in the X-ray fluoroscopy room and actually swallows liquids containing barium, viscous liquids, pastes, or jellies. The delayed laryngeal elevation time (LEDT), an indicator used in swallowing imaging, is measured by measuring the time from the tip of the contrast agent reaching the bottom of the piriform depression in the lateral image until the laryngeal elevation reaches its maximum position. A shorter (smaller) LEDT indicates recovery of swallowing symptoms, and the determined LEDT value is displayed as displayed data.

Under the above conditions, sensory thresholds were measured in 81 healthy individuals of both sexes (aged 16 to 68). The results are shown in Figure 1. The average sensory threshold was confirmed to be 1.05 mA, with a maximum of 2.18 mA and a minimum of 1.08 mA. Furthermore, when stimulation was applied using a pair of electrodes using simulated interference waves, results similar to those in Figure 1 were obtained.

Next, for three patients (subjects) who were diagnosed with dysphagia based on the results of delayed time to lift from the larynx (LEDT), continuous interference wave stimulation was performed every day or at intervals of 3 days for 10 to 30 minutes each time (1 to 3 times/day). The patients were 82 to 87 years old, and their initial sensory thresholds (initial data) were 2.61, 2.8, and 2.89 mA, respectively. The values of the sensory thresholds were approximately twice the average value of 1.05 for the healthy subjects. The initial LEDT (sec) values of the three patients were 1.567, 0.233, and 0.533, respectively. The treatment was performed continuously for up to 60 times on the three patients. During the treatment, the sensory threshold was measured each time, and the measurement result data was input, recorded, and saved. The sensory threshold obtained from each treatment was used as a benchmark or reference to set the treatment conditions for the next time.

Figures 2 to 4 show the results of sensory threshold measurements for patient subjects 1 to 3, respectively, after stimulation with interfering waves was applied. The vertical axis represents sensory threshold current (mA), and the horizontal axis represents the number of tests. Patient subjects 1 and 2 were tested daily, while patient subject 3 was tested every three days.

Patient 1 (initial values: sensory threshold 2.61 mA, LEDT 1.567 seconds) did not see its sensory threshold drop below 2.0 mA until the 38th treatment. However, it showed a gradual downward trend, with the sensory threshold dropping to 2.18 mA and LEDT to 0.133 seconds at the 39th treatment. By the 53rd treatment, the sensory threshold had dropped to 1.88 mA. The degree of dysphagia was assessed using LEDT values, and significant improvement was observed by the 14th treatment.

Patient subject 2 (initial values: sensory threshold 2.8 mA, LEDT 0.233 (sec)) had its sensory threshold reduced to 2.16 mA after 7 treatments, and its LEDT reduced to 0.066 at the 8th treatment. The degree of dysphagia was sufficiently improved after about 7 treatments.

Patient 3 (initial values: sensory threshold 2.89 mA, LEDT 0.533 sec) did not experience a drop to 2.0 mA until the third treatment. However, after the fourth treatment, the sensory threshold showed a tendency to drop gradually, reaching 1.43 mA by the fifth treatment. Meanwhile, LEDT decreased to 0.333 sec after the fifth treatment, indicating improvement in the degree of dysphagia.

Furthermore, for a patient (subject) who was diagnosed with dysphagia based on the results of the delayed time for laryngeal elevation (LEDT), continuous interference wave stimulation was performed at daily intervals for 10 to 30 minutes each time (1 to 3 times/day). The patient was 91 years old and his initial sensory threshold (initial data) was 1.90 mA. The initial LEDT (sec) value of this patient was 0.467. Treatment was continued for this patient 22 times. During the treatment, the sensory threshold was measured each time, and the measurement result data was input, recorded and saved. The sensory threshold obtained in each treatment was used as a benchmark or reference to set the treatment conditions for the next time.

Figure 5 shows the results of measuring the sensory threshold of this patient subject, who was stimulated by interferential waves. The patient was a 90-year-old woman, and continuous interferential wave stimulation was applied for 20 minutes each time (twice a day). Even for this patient subject, the sensory threshold showed a trend of decrease with treatment. In addition, by the 21st treatment, the LEDT had dropped to 0.167 (sec), and the degree of dysphagia had also improved significantly.

The above results confirm the correlation between the degree of dysphagia and the sensory threshold. Furthermore, the effectiveness of output values used to set the next treatment condition based on the sensory threshold, which is continuously measured and recorded, has been confirmed. This method enables the dysphagia treatment device to automatically set the next treatment condition corresponding to the degree of dysphagia treatment improvement based on the sensory threshold obtained in each measurement.

The above results can be treated with two pairs of output systems, or one pair of output systems can be used with the same continuous interference wave output, or two pairs of systems, one pair of which is a system with only intermittent (1 second interval) interference waves, and the other pair of which is a system with intermittent (1 second interval) interference waves and non-interference waves. Several preliminary experiments are conducted to infer that the correlation between the decrease in sensory threshold and the improvement in the degree of swallowing disorders is the same.

<Specific Configuration Example of Device>

6(a) to 10(c), a specific configuration example of a dysphagia treatment device will be described. The dysphagia treatment device described in this configuration example has a function for detecting dysphagia and a function for performing dysphagia treatment based on the detection results.

In this configuration example, step s15 of Figure 9(a) is equivalent to the "assignment step" in claims 18 and 19, steps s12 to s15, s17, and s18 of Figure 9(a) are equivalent to the "acquisition step" in claims 18 and 19, step s16 of Figure 9(a) is equivalent to the "display step" in claim 18, and step s19 of Figure 9(a) is equivalent to the "output step" in claim 19.

Fig. 6(a) is an external structural diagram showing the dysphagia treatment device 1 in a state where the device is mounted on a patient M1. Fig. 6(b) is a perspective view showing a state where the device body 2 is mounted with a charger 4.

As shown in FIG6(a), the dysphagia device 1 includes a treatment device body 2 and a current applying unit 3. The treatment device body 2 includes a display unit 21 and an operating unit 22. The display unit 21 displays information such as the current value applied transcutaneously to the patient M1 by the current applying unit 3 and the treatment time set by the operator. The operating unit 22 includes keys for increasing or decreasing the current value applied transcutaneously to the patient M1 and a key for setting the treatment time. The treatment device body 2 is of a portable size that can be held by hand.

As shown in Figure 6(b), the treatment device body 2 is installed with a charger 4 and is charged. For convenience, the power cord connected to the charger 4 is omitted in Figure 6(b). The power cord is connected to the connector 4 of the charger 4. The charger 4 further includes a light 42 that indicates the charging status. As shown in Figure 6(b), the charger 4 is installed on the treatment device body 2, and the power receiving connector (not shown) of the treatment device body 2 is connected to the power supply connector (not shown) of the charger 4. The treatment device body 2 has a connector 23 on the side for connecting to the connector 31 of the current applying unit 3.

As shown in Figure 6(a), the current applying unit 3 includes a connector 31, a wire 32, an electrode 33, and pads 34 and 35. The connector 31 is connected to the connector 23 of the treatment device body 2. The wire 32 is connected to the connector 31 and the electrode 33. The electrode 33 consists of two positive electrodes 33a and 33c, and two negative electrodes 33b and 33d. Here, the positive electrode 33a and the negative electrode 33b form a pair of electrodes 33, and the positive electrode 33c and the negative electrode 33d form a pair of electrodes. The positive electrode 33a and the negative electrode 33b are attached to the pad 34 on one side, and the positive electrode 33c and the negative electrode 33d are attached to the pad 35 on the other side.

As shown in Fig. 6(a), two pairs of electrodes 33 are attached to the neck, with positive electrodes 33a, 33c and negative electrodes 33b, 33d arranged in an X-shape on the neck of the patient M1. The pads 34, 35 are made of a thin and flexible material.

FIG7 shows a block diagram of the therapeutic device body 2.

In addition to the display unit 21, operating unit 22, and connector 23 shown in Figures 6(a) and (b), the treatment device body 2 includes an electrode driver 24, a power supply 25, a current detector 26, a control unit 27, and a memory unit 28. Block 2a primarily addresses dysphagia treatment, while block 2b primarily addresses dysphagia testing. The configuration of a dysphagia testing device that does not perform dysphagia treatment is identical to that of block 2b. In this dysphagia testing device, only steps S11 through S18 are performed in the processing described later with reference to Figure 9(a).

The electrode driving unit 24, under the control of the control unit 27, applies a voltage of a predetermined frequency to the paired positive electrodes 33a and 33b, and the paired positive electrodes 33c and negative electrodes 33d, via the connector 23. The power supply unit 25 includes a rechargeable battery that is charged with power supplied by the charger 4 shown in FIG6(b), and the charged power is supplied to various components.

The current detecting unit 26 measures the current flowing from the electrode driving unit 24 into the positive electrodes 33a, 33c and the negative electrodes 33b, 33d, that is, the current applied percutaneously to the subject M1, under the control of the control unit 27, and stores the measured current value in the storage unit 28.

The control unit 27 is composed of a calculation processing circuit such as a CPU (Central Processing Unit) and controls each component according to the control program stored in the memory unit 27. The memory unit 28 includes storage media such as ROD (Read Only Memory) and RAM (Random Access Memory). In addition to storing the control program, the memory unit 28 also stores various information such as the current value detected by the current detection unit 26. The memory unit 28 also serves as a work area for the control unit 27.

Fig. 8(a) schematically shows a waveform of a voltage applied by a pair of electrodes 33 (eg, a positive electrode 33a and a negative electrode 33b), and Fig. 8(b) schematically shows the operation of the dysphagia treatment device 1 when a voltage is applied.

As shown in FIG8(a), the electrode driving unit 24 applies a rectangular wave voltage of a predetermined frequency from a pair of electrodes 33 (e.g., a positive electrode 33a and a negative electrode 33b) to the neck of the patient M1. Here, the rectangular wave oscillates between +Vp and -VP. The rectangular wave is set to a predetermined duty ratio. Furthermore, the frequency (carrier frequency) of the rectangular wave is set to between 500 and 8000 Hz. Preferably, the frequency (carrier frequency) of the rectangular wave is set to between 1000 and 4000 Hz, and more preferably, it is set to between 1500 and 3000 Hz. The applied voltage does not necessarily need to be a rectangular wave; for example, it may be a sine wave.

Accordingly, when voltage is applied to the neck of the patient M1, a current flows transcutaneously into the superior laryngeal nerve of the patient M1. Here, by creating a difference between the frequency of the voltage applied to one side of the paired electrodes 33 (e.g., the positive electrode 33a and the negative electrode 33b) and the frequency of the voltage applied to the other side of the paired electrodes 33 (e.g., the positive electrode 33c and the negative electrode 33d), an interfering current wave is generated. This interfering wave is then applied to the superior laryngeal nerve of the patient M1. This stimulates the superior laryngeal nerve, thereby treating the patient M1's dysphagia.

The frequency of the interference wave (difference frequency, that is, the frequency for treating dysphagia) is set to the frequency difference between the two pairs of electrodes 33. The frequency of the interference wave is set to 10 to 100 Hz, preferably 20 to 80 Hz, and more preferably 30 to 60 Hz.

In the example of Figure 8(b), a 2050 Hz voltage is applied to the neck of the treated patient M1 from one side of the paired electrodes (positive electrode 33a and negative electrode 33b), while a 2000 Hz voltage is applied to the neck of the treated patient M1 from the other side of the paired electrodes (positive electrode 33c and negative electrode 33d). As a result, the 2050 Hz and 2000 Hz current waves propagate toward the superior laryngeal nerve, and a 50 Hz perturbation wave acts on the superior laryngeal nerve.

By varying the amplitude (intensity) of the voltage applied to each pair of electrodes, the amplitude of the current wave changes, and accordingly, the intensity of the interference wave acting on the superior laryngeal nerve also changes. Therefore, by adjusting the amplitude of the voltage applied to each pair of electrodes, the stimulation imparted to the superior laryngeal nerve of the treated subject M1 can be adjusted to an intensity appropriate for treatment. The voltage applied to each pair of electrodes is set to the same amplitude.

Fig. 9(a) is a flowchart showing a process of setting a current value for treatment (treatment current value). Fig. 9(b) is a diagram showing a screen configuration displayed on the display unit 21 of the treatment device body 2 and a configuration of the operation unit 22.

9( b ), the display unit 21 includes a voltage scale area 211, an indicator area 212, a current value area 23, a timer area 214, and a battery area 215. The display unit includes, for example, a liquid crystal display.

The voltage scale area 211 displays four scales for numerically displaying the voltage level applied to the neck by the electrode 33. Specifically, the four scales of 0, 5, 10, and 15 are displayed at equal intervals in a vertical arrangement within the voltage scale area 211. The indicator area displays an indicator that changes in height from the 0 mark to the 15 mark. The height of the indicator represents the voltage level applied to the neck by the electrode 33, and thus changes according to the amplitude of the rectangular wave shown in FIG8(a).

Current value area 213 displays the current value measured by current detection unit 26 in FIG7 , that is, the effective value of the current applied transcutaneously from electrode 33 . Current value area 213 also displays the current value in mA (milliamperes). Timer 214 displays the treatment time set by an operator such as a physician. Battery unit 215 displays the remaining power of power supply unit 25 in FIG7 .

The operating unit 22 includes a power button 221, a timer button 222, an UP button 223, and a DOWN button 224. The power button 221 is used to start and stop the treatment device 2. The timer button is used to set the treatment value. The UP and DOWN buttons are used to set the treatment time and adjust the voltage value. Each button is, for example, a mechanical push button that produces a click feeling when pressed.

To set the treatment time, the operator presses timer key 222. This causes the default time to be displayed in timer area 214. The operator can increase the treatment time by pressing UP key 223 and decrease it by pressing DOWN key 224. After adjusting the treatment time to the desired value, the operator presses timer key 222 again. The time displayed in timer area 214 is set as the treatment time.

Next, referring to FIG9 (a), the process of setting the current value used for treatment (treatment current value) will be described. Note that this process is performed after the treatment time is set. The process of FIG9 (a) is performed by the control unit 27.

Furthermore, in the process of setting the treatment current value, the UP key 223 is used to increase the voltage applied to the neck from the electrode 33, and the UP key 224 is used to decrease the voltage applied to the neck from the electrode 33. If the UP key 223 is operated when the applied voltage level is at the highest value, the control unit 27 ignores this operation. Furthermore, if the DOWN key 224 is operated when the applied voltage level is at the lowest value (0), the control unit 27 ignores this operation.

After the two pairs of electrodes 33 shown in FIG6 are attached to the neck of the patient M1, power is input and the treatment time is set as described above (S11), the control unit 27 determines whether the UP key 223 or DOWN key 224 of the operation unit 22 is operated (S12).

Immediately after the treatment device body 2 is turned on, the control unit 27 only determines whether the UP key 223 has been operated to prevent voltage from being applied to the electrodes 33 (S12). If the UP key 223 has been operated (S12: YES), the control unit 27 determines whether this is the first operation since power was applied (S13). If this is the first operation (S13: YES), the control unit 27 starts a built-in timer (S14). Then, in response to the operation of the UP key 223, the control unit 27 increases the output voltage of the electrodes 33 to a certain degree. This causes current to flow from the neck of the patient M1 to the upper laryngeal nerve. The control unit 27 obtains the measured value of this current (current value Im) from the current detection unit 26 in Figure 7 and displays the obtained measured value on the display unit 21 (S16). The measured current value is displayed in the current value area 213 in Figure 9(b).

Next, the control unit 27 determines whether the time T started in step S14 has reached the predetermined time Ts (S17). Time Ts is set to, for example, approximately one minute. If time T has not reached time Ts (S17: NO), the control unit returns to step S12 and determines whether the UP key 223 or DOWN key 224 has been operated. If the UP key 223 or DOWN key 224 has been operated (S12: YES), since this operation is not the first operation (S13: NO), the control unit increases or decreases the output voltage of the electrode 33 according to the operation of the UP key 223 or DOWN key 224 (S15). This increases or decreases the current flowing in, causing the current value Im displayed in the current value display area 213 of Figure 9(b) to change (S16).

Thereafter, the control unit 27 increases or decreases the output voltage of the electrode 33 (S12 to S15) in response to the operation of the UP key 223 or the DOWN key 224 until the time T reaches the time Ts (S17). Consequently, the current value Im displayed in the current value display area 213 of FIG9(b) changes (S16).

The operator, such as a physician, operates the UP key 223 or DOWN key 224 to adjust the output voltage of the electrode 33 to the minimum voltage level at which the patient M1 perceives stimulation from the interfering wave. More specifically, the output level is varied by operating the UP key 223 or DOWN key 224. When the patient M1 perceives stimulation from the interfering wave, the operator simultaneously prompts the patient to report the change. This operation allows the operator to explore the minimum voltage level at which the patient M1 perceives stimulation from the interfering wave. Once the exploration is complete, the operator completes the UP key 223 or DOWN key 224 operation and waits until time T reaches time Ts. Time Ts is the period used to explore and determine the sensory threshold Is for the patient M1.

When time T reaches time Ts (S17: YES), the control unit 27 completes time T and acquires the current value Im displayed on the display unit 21 at that point as the sensory threshold Is at which the patient M1 perceives transcutaneous stimulation (S18). The acquired sensory threshold Is is displayed in the current value area 23 of the display unit 21 in step S16. Based on this sensory threshold Is, the control unit 27 then sets the therapeutic current value It for the patient M1's dysphagia (S19).

Here, the therapeutic current value It is set, for example, to a current value that reduces the output level of the two pairs of electrodes 33 by only one degree when the sensory threshold Is is achieved. In this case, in step S19, the output level of the two pairs of electrodes 33 is reduced by only one degree. By slightly reducing the therapeutic current value It from the sensory threshold Is in this manner, effective transcutaneous stimulation for dysphagia treatment is provided to the patient M1 while suppressing the discomfort caused by the stimulation.

Alternatively, the treatment current value It may be set to, for example, the sensory threshold Is. In this case, in step S19, the output levels of the two pairs of electrodes 33 are maintained as they are. This provides effective transcutaneous stimulation for dysphagia treatment to the patient M1.

Alternatively, the therapeutic current value It can be set to a current value that increases the output level of the two pairs of electrodes 33 by only one degree when the sensory threshold Is is obtained. In this case, in step S19, the output level of the two pairs of electrodes 33 is increased by only one degree. By slightly increasing the therapeutic current value It from the sensory threshold Is in this manner, more effective transcutaneous stimulation for dysphagia treatment can be provided.

Afterwards, the control unit 27 stores the therapeutic current value It as pointer information based on the sensory threshold in the memory unit 28 of FIG7 (S20). This completes the setting process of the therapeutic current value It. Afterwards, the dysphagia treatment device 1 will continue the treatment action using the therapeutic current value It. As described above, during the treatment action, the interference wave is repeatedly applied and not applied to the superior laryngeal nerve, or the interference wave is continuously applied to the superior laryngeal nerve.

In addition, in step S20, the treatment current is stored in the memory unit 28 as pointer information based on the sensory threshold. However, the sensory threshold Is obtained when the judgment in step S17 is YES can also be stored in the memory unit 28 as pointer information based on the sensory threshold.

Furthermore, when the therapeutic current value increases or decreases relative to the sensory threshold Is, in step S20, the current detection unit 26 of FIG. 7 again measures the current value (the therapeutic current value), and the measured current value is stored in the memory unit 28 as indicator information based on the sensory threshold. Alternatively, the control unit 27 may calculate the current value required to reduce the output level of the electrode 33 by a certain degree based on the sensory threshold Is, and store the calculated current value in the memory unit 28 as indicator information based on the sensory threshold.

In addition, the sensory threshold value Is obtained in step S18 is displayed in the current value area 213 of Figure 9(b) from the time when the display is updated in the previous step S16. Thereafter, when the therapeutic current value It is set in step S19, the display of the current value area 213 is updated to the therapeutic current value It. At this time, the operator grasps either the sensory threshold value Is displayed before the change or the therapeutic current value It displayed after the change as pointer information based on the sensory threshold. However, the difference between the sensory threshold value Is and the therapeutic current value It is at most a slight difference in the current value when the output level of the electrode 33 differs by one degree, so grasping either the sensory threshold value Is or the therapeutic current value It as evaluation information of dysphagia is not much different. Both the sensory threshold value Is and the therapeutic current value It can be used as pointer information based on the sensory threshold.

10( a ) and ( b ) show changes in the output level of the electrode 33 when the UP key 223 and the DOWN key 224 are operated, respectively.

As shown in FIG10( a ), the output level of electrode 33 increases gradually by one level each time UP key 223 is pressed. Furthermore, even if UP key 223 is pressed for a long time, the output level of electrode 33 increases by only one level. One level is a predetermined voltage value.

As shown in Figure 10(b), the output level of electrode 33 decreases gradually, one level at a time, each time DOWN key 224 is pressed. Furthermore, when DOWN key 224 is held down, the output level of electrode 33 continues to decrease, one level at a time. This is the same level as when UP key 223 is pressed. Thus, while DOWN key 224 is held down, the output level of electrode 33 is controlled to continuously decrease. This allows for rapid elimination of discomfort caused by excessively high output levels.

Fig. 10(c) schematically shows a time chart of the current value change until the treatment current value It is set. This time chart shows the case where the treatment current value It is lowered to a certain degree below the sensation threshold Is.

In this example, the operator presses UP key 223 four times between times t1 and t2. As a result, the output level of electrode 33 increases by four degrees, and the value of the flowing current increases by four degrees in a stepwise manner. Since the operation of UP key 223 at time t1 is the first operation, the timing of time T begins at time t1.

Subsequently, between times t3 and t4, the operator further presses UP key 223 three times, causing the current value to increase by three steps. This increase in current causes the subject M1 to perceive transcutaneous stimulation of the superior laryngeal nerve, etc., at time t5, and reports this. Receiving this, the operator presses DOWN key 224 once, causing the current value to decrease by one step.

Afterward, between times t6 and t7, since patient M1 did not consciously report any stimulation, at time t7, the operator pressed UP key 223 once, causing the current flowing into the superior laryngeal nerve to gradually increase. Consequently, at time t8, patient M1 consciously reported any stimulation, and the operator, regarding the current value at that point as the sensory threshold, terminated the UP/DOWN operation.

Then, at time t9, when time T reaches time Ts, the current value at that time is obtained as the sensation threshold Is. Simultaneously, the control unit 27 reduces the electrode output by a certain amount, setting it to the treatment current value It. Thereafter, treatment control using the treatment current value It continues until the treatment time set by the operator has elapsed. After the treatment time has elapsed, the output of the electrode 33 is stopped, completing the treatment of the patient M1.

In addition, in FIG10(c), by operating the UP key 223 and the DOWN key 224, the current value rises and falls in stages with a predetermined change range. However, this change range is not the same for all patients, but is different for each patient. In other words, the resistance value when the voltage is applied to the neck varies depending on the thickness of the neck and the bones. Therefore, the change range of the current value when the output of the electrode 33 changes by one degree becomes different for each patient according to the neck resistance value of each patient. Therefore, even if the degree of dysphagia is the same for each patient, it is not limited to the same time chart as shown in FIG10(c). Depending on the neck resistance value, the number of UP/DOWN operations and the accompanying change in current value may be different.

FIG11(a) is a flowchart showing the display process of history information.

During treatment using the dysphagia treatment device 1, at each treatment session, the treatment current value It is stored in the memory unit 28 as dysphagia indicator information in step S20 of FIG. At this time, the treatment current value It and the output value (voltage level) of the electrode 33 at the time the treatment current value It was obtained are stored in the memory unit 28. This information is stored in the memory unit 28 in sequence, associated with the chronological order of the storage process. The operator can display the historical information (indicator information, voltage level) stored in the memory unit 28 on the display unit 21 as appropriate.

Referring to Figure 11(a), when power is supplied to the therapeutic device body 2 (S21), the control unit 27 determines, through the operator, whether an operation to display past pointer information has been performed (S22). This operation can be performed, for example, by simultaneously pressing the DOWN key 224 and the timer key 222. If this operation has been performed (S22: YES), the control unit 27 sets the parameter N to 1 (S23), reads historical information (pointer information, voltage level) from the memory unit 28 N times ago (here, 1 time ago), and displays it on the display unit 21 (S24).

FIG11( b ) shows an example of the display of historical information at this time. Here, pointer information (current value) based on the sensory threshold value obtained during the previous treatment is displayed in the current value area 213 of the display unit 21. Furthermore, the voltage level applied from the electrode 33 when this pointer information was obtained is displayed in the indicator area 212 of the display unit 21. Furthermore, instead of the timer area 214, a sequence area 216 is allocated to display the chronological order of historical information. The historical information displayed in this sequence area 216 is historical information obtained during several previous treatments. In the example of FIG11( b ), the historical information obtained during the previous treatment is displayed as "1."

Returning to Figure 11(a), the control unit 27 then determines whether the UP key 223 or the DOWN key 224 has been operated (S25, S26). If the UP key 223 has been operated (S25: YES), the control unit 27 increments the variable N by 1 (S27). If the DOWN key 224 has been operated (S26: YES), the control unit 27 decrements the variable N by 1 (S28). The control unit 27 then determines whether the operator has performed an operation to end the display of historical information (S29). This operation, for example, involves pressing the DOWN key 224 and the timer key 222 simultaneously again. If the determination in step S29 is NO, the control unit 27 returns the process to step S24.

In step S24, the control unit 27 reads the historical information from N treatments ago and displays it on the display unit 21. Since the variable N is updated in steps S27 or S28, the process of step S24 is performed based on the updated variable N. For example, if variable N is incremented by 1 in step S27, variable N becomes 2. In this case, in step S24, the historical information stored during the two previous treatments is read from the memory 28 and displayed on the display unit 21. As a result, "2" is displayed in the sequence area 216 in FIG11(b), and the pointer information (current value) and voltage level obtained during the two previous treatments are displayed in the current value 213 and indicator area 212, respectively.

Thus, the operator can refer to the pointer information and voltage levels obtained during a predetermined number of previous treatments by operating the UP key 223 and the DOWN key 224. Based on the referenced pointer information, the operator can understand the degree of improvement and progress of the swallowing disorder, thereby enabling appropriate treatment to be provided to the patient M1.

<Effect>

The dysphagia treatment device 1 can produce the following effects.

The pointer information based on the sensory threshold of the transcutaneous stimulation perceived by the patient M1 is displayed as a dysphagia evaluation pointer on the display unit 21. Therefore, the operator can evaluate the dysphagia condition of the patient M1 based on the output pointer information.

Furthermore, the therapeutic current value It is adjusted according to the degree of dysphagia of the patient M1. Therefore, stimulation appropriate to the degree of dysphagia of the patient M1 can be transcutaneously applied to the laryngeal nerve of the neck of the patient M1, thereby effectively promoting the treatment of dysphagia.

Furthermore, a method is used in which different current frequencies are applied from two pairs of electrodes 33 to percutaneously apply interference waves caused by the current to the superior laryngeal nerve in the deep neck of the patient M1. This reduces the burden on the patient M1 and effectively facilitates the examination and treatment of dysphagia.

Furthermore, during the examination and treatment of dysphagia, the degree of stimulation of the superior laryngeal nerve of the patient M1 can be adjusted by operating the UP key 223 and the DOWN key 224 shown in FIG11(b). Therefore, the operator can easily and smoothly perform the examination and treatment of dysphagia.

Furthermore, as shown in FIG10(c), the applied current level changes in stages when UP key 223 and DOWN key 224 are pressed. Since the current value changes in stages, the operator can monitor the reaction of the treated patient M1 based on the current value after pressing UP key 223 and DOWN key 224, and wait for a report from the treated patient M1. This allows the operator to smoothly advance the search for the sensory threshold Is.

Furthermore, as shown in Figure 10(c), in a dysphagia examination, when the time T elapsed from the start of the manipulation to stimulate the superior laryngeal nerve with an interference wave reaches a predetermined threshold time Ts, the current value at that time is obtained as the sensory threshold Is, and the treatment is transitioned to therapy. This allows the operator to explore the sensory threshold while varying the current value during the threshold time Ts. Once the sensory threshold is explored, the system can simply be left as is, transitioning to therapy based on the sensory threshold Is.

Furthermore, as shown in FIG11( b ), when the historical display operation is performed, the dysphagia indicator information (current value) and voltage level obtained during past treatments are displayed on the display unit 21. Therefore, by referring to the past indicator information, the operator can understand the degree of improvement of the patient's dysphagia and the progress of the improvement. This allows the operator to implement appropriate treatment for the patient.

11(b), when the UP key 223 or the DOWN key 224 is operated, the past pointer information displayed on the display unit 21 is displayed in chronological order. Therefore, the operator can smoothly refer to the desired past information pointer through simple operations.

Furthermore, as shown in steps S18 and S19 of FIG9(a), the sensory threshold Is is linked to the acquired information by operating the operating unit 22, automatically setting the therapeutic current value It used for treatment. This eliminates the need to refer to the sensory threshold Is to set the therapeutic current value It, thereby improving the operability and convenience of the dysphagia treatment device 1.

<Change Example 1>

Fig. 12(a) is a flowchart of the mode setting process according to the modification example 1. Fig. 12(b) is a flowchart of the treatment current value setting process according to the modification example 1.

In Modification 1, the operator can select any of three modes for setting the treatment current value It in step S19 of FIG9(a). Mode A sets the treatment current value It while maintaining the sensation threshold Is. Mode B and Mode C set the treatment current value It to a current value that lowers or raises the sensation threshold Is by a certain amount, respectively.

Referring to Figure 12(a), when power is input (S31), the operation unit determines whether a predetermined mode setting operation has been performed on the operation unit 22 (S32). If this operation has been performed (S32: YES), the control unit 27 displays the mode setting screen on the display unit 21 (S33). The operator operates the UP key 223 and DOWN key 224 to select the desired mode, and then performs an operation to confirm the mode setting. When the mode setting is completed (S34: YES), the control unit 27 stores the set mode as the mode for processing in step S19 (S35). This completes the mode setting.

In Modification 1, the process of FIG12(b) is performed in step S19 of FIG9(a). The control unit 27 determines whether the mode set by the operator is mode A to C. If the operator does not set a mode, the default mode, for example, mode B, is set.

If the set mode is Mode A (S41: YES), the control unit 27 sets the voltage level Vt of the electrode 33 to the voltage level Vs at the time the sensory threshold Is was obtained (S42). This sets the sensory threshold Is to the therapeutic current value It. If the set mode is Mode B (S41: NO, S43: YES), the control unit 27 sets the voltage level Vt of the electrode 33 to a current value that is one degree lower than the voltage level Vs at the time the sensory threshold Is was obtained (S44). This sets the current value that is one degree lower than the sensory threshold Is as the therapeutic current value It. If the set mode is Mode C (S41: NO, S43: NO), the control unit 27 sets the voltage level Vt of the electrode 33 to a current value that is one degree higher than the voltage level Vs at the time the sensory threshold Is was obtained (S45). This sets the current value that is one degree higher than the sensory threshold Is as the therapeutic current value It.

According to Modification 1, the operator can appropriately select a mode for setting the treatment current value It. Therefore, the degree of freedom in setting the treatment current value It can be increased, and the operator can perform treatment on the patient by considering a mode that is appropriate for the treatment.

In Modification 1, three modes, Modes A to C, are selectable as the modes for setting the therapeutic current value It. However, the selectable modes are not limited to these. For example, two modes from Modes A to C may be selected, or other modes may be selected. Furthermore, ΔV in steps S44 and S45 of FIG. 12( b ) does not necessarily correspond to the voltage level variation during the sensory threshold Is search process; in other words, it may differ from the variation corresponding to one stage in FIG. 10( a ) and ( b ).

<Change Example 2>

FIG12(c) shows a flowchart of the treatment current value setting process according to Modification 2. In Modification 2, step S20 in FIG9(a) is changed to S20'. Specifically, in step S20', control unit 27 stores the sensory threshold value Is obtained in step S18 in memory unit 28 as is. Therefore, the operator can refer to sensory threshold value Is as index information from past treatments by referring to FIG11(b) and performing the operations described above.

<Other Changes>

In the process shown in FIG9(a), the current value Im at the time when the time T reaches the threshold time Ts is obtained as the sensation threshold value Is. However, as shown in FIG13(a), a confirmation key 225 for determining the sensation threshold value Is may be provided on the operating unit 22, and the current value Im at the time when the confirmation key 225 is operated is obtained as the sensation threshold value Is.

In the process shown in FIG9(a), the sensory threshold Is is obtained (S18) and the therapeutic current value It is set and stored (S19, S20) based on the time elapsed from the time when the electrode voltage increase/decrease operation is first performed to the predetermined time Ts. However, the sensory threshold Is can be obtained (S18) and the therapeutic current value It is set and stored (S19, S20) based on the time elapsed from the time when the electrode voltage increase/decrease operation is last performed to the time Ts. In this case, step S13 is removed from the flowchart of FIG9(a).

In addition, in the display form of FIG9(b), the intensity of the current (including the sensory threshold Is) flowing transcutaneously into the neck of the treated patient M1 is displayed as a digital representation of the effective value of the current. However, the display form of the intensity of the current flowing transcutaneously into the neck is not limited to this. For example, as shown in FIG13(b), the intensity of the current (including the sensory threshold Is) flowing transcutaneously into the neck of the treated patient M1 can be displayed in the level area 217, or the current intensity level can be displayed by an indicator similar to the voltage value.

Furthermore, when an excessive current exceeding a predetermined threshold is applied to the neck of the patient M1 during the acquisition of the sensory threshold Is and during treatment, a warning display 218 indicating the occurrence of an overcurrent may be displayed, as shown in FIG14(a). Furthermore, when an overcurrent occurs, the voltage level may be automatically reduced or the application of voltage may be interrupted.

At this time, the control unit 27 in Figure 7 performs the control shown in Figure 14(b) or Figure 14(c). Specifically, in the control shown in Figure 14(b), the control unit 27 monitors the current value Im detected by the current detection unit 26 (S51). When the current value Im exceeds the threshold value Iw (S51: YES), the control unit 27 displays the warning display 218 shown in Figure 14(a) on the display unit 21 (S52). Alternatively, in the control shown in Figure 14(c), when the current value Im exceeds the threshold value Iw (S51: YES), the control unit 27 further reduces the output voltage of only the electrode 33 to a predetermined level (S53). In step S53, the voltage output from the electrode 33 can be reduced. This control can suppress significant discomfort inflicted on the patient M1, allowing for smoother examination and treatment of the patient M1. Furthermore, the overcurrent notification method can include, in addition to displaying the information on the display unit 21, emitting a sound, illuminating a light source, or other methods.

Furthermore, when displaying pointer information obtained during past treatments, as shown in Figure 15(a), the pointer information can further display the date 219 on which the information was obtained. In this case, the memory unit 28 stores the pointer information along with information indicating the date the treatment was performed. In this case, step S20 in Figure 9(a) is changed to step S20' in Figure 15(b), and the treatment current value It is stored in the memory unit 28 along with the current date and time. This allows the operator to know when the past pointer information was obtained, allowing them to more accurately assess the progress of dysphagia improvement.

10(a) to (c), the voltage and current applied to the treated object M1 change in stages in response to the operation. However, the voltage and current do not necessarily need to change in stages, and may also change linearly in response to the operation voltage and current.

In addition, in the above-described configuration example, the current value applied percutaneously to the treated person M1 is adjusted by controlling the voltage, but as the current value measured by the current detection unit 26 can display a predetermined change according to the operation of the UP key 223 and the DOWN key 224, the current value applied percutaneously to the treated person M1 can be adjusted by current control.

In addition, in the processing of Figure 9(a), the treatment current value It is automatically set based on the obtained sensory threshold Is, but the swallowing disorder treatment device 1 can also be constructed by having the operator manually set the treatment current value It with reference to the displayed sensory threshold Is.

In addition, in the configuration of FIG6( a ), the patient M1 is provided with two pairs of electrodes 33. However, the number of pairs of electrodes 33 provided to the patient M1 is not limited to this number. As long as the interfering wave can be delivered transcutaneously to the superior laryngeal nerve, the number of pairs of electrodes 33 provided to the patient M1 can be one or three or more. When using a pair of electrodes 33, for example, by delivering an amplitude-modulated current to the electrodes 33, the interfering wave can be delivered transcutaneously to the superior laryngeal nerve. In this case, the amplitude-modulated frequency has the same effect as the difference frequency (therapeutic frequency).

In addition, in the above configuration, the index information for evaluating the presence and degree of dysphagia is obtained as the current value applied transcutaneously to the neck of the treated person M1. However, the index information does not necessarily need to be the current value, and other information may also be used as long as it is related to the sensory threshold.

Main component symbols

1. Dysphagia treatment device

2 Treatment device body

3 Current applying unit

21 Display unit

22 Operation section

26 Current detection unit

27 Control Department

28 Memory Department

33 electrodes

213 Current value area

217 degree area

223 UP key

224 DOWN key.

Claims (16)

1. A device for examining swallowing disorders, comprising: The current-applying unit is attached to the target area of the patient in order to percutaneously apply current to the living tissue of the neck containing the superior laryngeal nerve. A control unit that controls the current application unit to apply transdermal stimulation caused by interference waves or simulated interference waves to the biological tissue; An operating unit is used to adjust the current supplied by the current supply unit to a sensory threshold value of the minimum current value that the subject can perceive through the transcutaneous stimulation. A display unit shows pointer information for assessing swallowing difficulties, based on the sensory threshold; and The memory section stores the pointer information. The operation unit includes a key for displaying the pointer information stored in the memory unit. When the key used to display the pointer information is operated, the control unit causes the pointer information already stored in the memory unit to be displayed on the display unit. 2. The swallowing disorder examination device according to claim 1, wherein the current supply unit has electrodes attached to the neck of the subject, with positive and negative electrodes paired. 3. The swallowing disorder examination device according to claim 2, wherein the current imparting part has two pairs of electrodes paired with positive and negative electrodes. 4. The swallowing disorder examination device according to claim 3, wherein the control unit sets the frequency of the current supplied by the two pairs of electrodes to a predetermined value in the range of 500 to 8000 Hz, and sets the frequency difference of the current supplied by the two pairs of electrodes to a predetermined value in the range of 10 to 100 Hz. 5. The swallowing disorder examination device according to any one of claims 2 to 4, wherein, in the process of obtaining the sensory threshold, the control unit changes the current transdermally applied to the biological tissue by changing the voltage applied by the electrodes according to the operation of the operation unit. 6. The swallowing disorder examination device according to any one of claims 1 to 4, wherein, The operating unit includes a key for increasing or decreasing the current supplied by the current supply unit. The control unit increases or decreases the current supplied by the current supply unit based on the operation of the key. 7. The swallowing disorder examination device according to claim 6, wherein the control unit increases or decreases the current supplied by the current supply unit in stages according to the operation of the key. 8. The swallowing disorder examination device according to claim 6, wherein the control unit starts timing in response to the key being operated, and at a time point when the time elapsed reaches a predetermined threshold, obtains the value of the current imparted by the current imparting unit as the sensory threshold of the subject, and displays the pointer information on the display unit based on the obtained current value. 9. The dysphagia testing device according to any one of claims 1 to 4, wherein the pointer information is the sensory threshold, or a current value for dysphagia treatment set according to the sensory threshold. 10. The swallowing disorder examination device according to claim 1, wherein the operation unit includes a key for transmitting the pointer information displayed on the display unit in the order stored in the memory unit. When the key that transmits the pointer information along the time axis is operated, the control unit transmits the pointer information displayed on the display unit in the order it is stored in the memory unit. 11. The swallowing disorder examination device according to any one of claims 1 to 4, wherein the control unit performs processing to report its intention when the current value supplied by the current supply unit exceeds a predetermined threshold. 12. A swallowing disorder treatment device, comprising: a swallowing disorder examination device as described in any one of claims 1 to 11, and A unit for setting the current value for treating the subject based on the sensory threshold adjusted by the operating unit. 13. The dysphagia treatment device according to claim 12, wherein the control unit automatically sets the current value for the treatment in the current supply unit when the sensory threshold is obtained via the operation unit. 14. The dysphagia treatment device according to claim 13, wherein the control unit sets the sensory threshold, a current value that raises the sensory threshold to a predetermined level, or a current value that lowers the sensory threshold to a predetermined level as a current value for the treatment. 15. The dysphagia treatment device according to claim 13 or 14, wherein the control unit performs a process for receiving a selection of either the sensory threshold or a current value that causes the sensory threshold to change to a predetermined degree as the current value for the treatment. 16. A device for treating dysphagia, comprising: The current-applying unit is attached to the target area of the patient in order to percutaneously apply current to the living tissue of the neck containing the superior laryngeal nerve. A control unit that controls the current application unit to apply transdermal stimulation caused by interference waves or simulated interference waves to the biological tissue; An operating unit is used to adjust the current supplied by the current supply unit to a sensory threshold value that allows the recipient to perceive the transcutaneous stimulation consciously. A display unit shows pointer information for assessing swallowing difficulties, based on the sensory threshold; and The memory section stores the pointer information. The operation unit includes a key for displaying the pointer information stored in the memory unit. The control unit displays the pointer information stored in the memory unit on the display unit when the key used to display the pointer information is operated. The control unit sets the current value for treating the subject to the current supply unit based on the sensory threshold adjusted by the operation unit.