JP6436756B2 - Dry mouth treatment device - Google Patents

Description

  The present invention relates to an apparatus for treating dry mice by promoting salivation of dry mouse patients by percutaneous interference wave electrical stimulation.

  Dry mice are also called xerostomia, a disease in which the amount of saliva secreted decreases and the oral cavity becomes dry. It is estimated that 8-30 million people are affected by dry mice in Japan, and 25% of the population in Europe and America.

  Causes of dry mice include administration of anticholinergic and sympathomimetic drugs, head and neck radiation therapy, chemotherapy with paclitaxel, cGVHD administration, salivary gland diseases, sarcoidosis, HIV diseases, viral diseases such as EB virus, Examples include primary biliary cirrhosis, bladder fibrosis, diabetes mellitus and the like. Symptoms include increased cavities, acute gingivitis and periodontal disease, articulation disorders, dysphagia, taste disorders, candidiasis, cracks and tingling in the tongue, pain in the oral mucosa, dryness / pain / cracking in the lips, Examples include salivary gland hypertrophy.

  Treatment of such dry mice includes plaque control as oral hygiene, oral hygiene guidance, dietary guidance, chlorhexidine mouthwash and fluoride mouthwash to reduce caries risk, strong denture use and denture care Thyroid, antifungal medication, nystatin troche, amphotericin troche, miconazole gel, etc., topical saliva substitute, sugar-free gum, candy, oral moisturizer, medications such as pilocarpine and cevimeline Administration has been made.

Known documents similar to the present invention include the following.
According to Japanese Unexamined Patent Application Publication No. 2008-295472 “Oral Function Measuring Device, Oral Function Measuring Method, Oral Function Measuring Device Control Device” of Cited Document 1, the salivary gland stimulation part that is crimped to the lower jaw vibrates at a low frequency, and the salivary gland is secreted. However, it is indispensable to press the lower jaw, and the burden on the patient is great for continued use. According to Special Reference 2008-507315 “Manufacturing method, test method and tester for electronically embedded device in oral cavity” of Cited Reference 2, it is a salivary gland electrical stimulator in the oral cavity and its impact on the human body is heavy. Met. Japanese Laid-Open Patent Publication No. 2011-188958, “Sjogren's Syndrome Treatment Device, Dry Mouth Treatment Device, and Dry Eye Treatment Device”, cited in Patent Document 3, is particularly useful for parotid gland and sublingual gland by means of a bag-like pad equipped with a sheet-like heater unit. And a treatment device for heating the periphery of the submandibular gland from above the skin, and there was a negative element of the operation of heating. U.S. Pat. No. 6230052 of cited document 4 “Apparatus and method for stimulating salivation” is an electrical stimulator supported on an implant material, which is an implantable micro-sized implant placed on the implant material. A device with a processor, a stimulating electronic module and a power supply, which was large. PCT applications WO02 / 06522A2 and WO02 / 06522A3 of Cited Reference 5 “MARKER AT THE ESTROGEN RECEPTOR GENE FOR DETERMINATION OF LOW BONEDENSITY PREDISPOSITION” were removable electrical stimulators to activate salivary gland secretion. US Pat. Nos. 4,519,400 and 6,463,405 “Saliva secretion stimulating device” of Cited References 6 and 7 are devices manufactured by Biosonics (19034, Pennsylvania, USA), and are used in nerve sensitive areas in the oral cavity. A device used to induce salivation by stimulation, the electrical signal generator including a power supply and sending electrical signals to the electrodes to stimulate the sensitive area.

Prior literature

JP2008-295472 Special table 2008-507315 JP 2011-188958 US Pat. No. 6230052 PCT application WO02 / 06522A2 U.S. Pat.No. 4,519,400 No.4637405

  The present invention is intended to provide a novel dry mouse treatment means, and is intended to provide a means by which many dry mouse patients can easily, safely, comfortably and easily receive treatment.

  In order to solve the above problems, the present inventors examined a method using electrotherapy, and in electrotherapy, focused on an interference wave that is not very irritating and soft and that reaches the deep subcutaneous region. We looked for ways to treat patients. In the interference wave, two pairs of electrodes are provided, and the control unit sets the frequency of the two pairs of electrodes to 500 to 8000 Hz, sets the frequency difference to 10 to 100 Hz, and further sets means for outputting these electrodes for 1 to 20 minutes. Using this, we set the electrode attachment position for stimulation of the submandibular gland and sublingual gland as the site to stimulate percutaneously, and confirmed the therapeutic effect of dry mice by setting the number of treatments to complete the present invention did.

  The apparatus for dry mouse treatment according to the present invention stimulates the submandibular gland and the sublingual gland by using a known interference wave electrical stimulation means and passing a current having a frequency interfering from a pair of electrodes percutaneously. Therefore, the patient was able to achieve a therapeutic effect with several treatments in a very short time without any pain to the patient.

  That is, currents having different frequencies for each pair of electrodes interfere around the lower jaw where the submandibular gland and sublingual gland are located, and percutaneously stimulate the submandibular gland and sublingual gland. By stimulating, saliva secretion is promoted, and the effect of treating dry mice is enhanced by several saliva secretion promoting effects.

  Since the dry mouse treatment apparatus according to the present invention causes currents having different frequencies for each electrode to flow and interfere with each other around the lower jaw, there is no feeling in the skin and muscles, and there is no sense of incongruity. It provides a means of treatment that can withstand long-term use.

  In addition, the dry mouse treatment apparatus according to the present invention is a means that has no skin sensation or physical sensation due to muscle movement, has almost no effect of electrical stimulation on the skin or muscle, and can stimulate only the part that is originally desired to be stimulated. Therefore, appropriate and natural stimulation of the submandibular and sublingual glands can be expected. In addition, since there is no unnatural skin and muscle reaction anywhere other than the stimulation site, it creates a virtuous cycle that can withstand prolonged use.

  The dry mouse treatment apparatus according to the present invention achieves the target effect by applying interference wave stimulation percutaneously. For example, when two pairs of electrodes, one pair and the other pair, are used, the interference wave performs electrical stimulation in the middle frequency range with slightly different frequencies between these electrodes, and generates a low frequency equal to the frequency difference due to interference in the deep part. It is a method to make.

  By using the interference wave, there is little pain and discomfort in the skin, and low frequencies can reach the deep part. For example, when percutaneous electrical stimulation is performed at 2000 Hz and 2050 Hz, a low frequency of 50 Hz is generated in the subcutaneous part. At this time, the medium frequency used for stimulation is called a carrier frequency, and the low frequency generated is called a beat frequency (treatment frequency). Hereinafter, the frequency of the current flowing from one pair of electrodes and the other pair of electrodes is referred to as “carrier frequency”, and the frequency generated by interfering with the carrier frequency is referred to as “treatment frequency”.

In the dry mouse treatment apparatus according to the present invention, the carrier frequency is preferably 500 to 8000 Hz, preferably 1000 to 4000 Hz, and more preferably 1500 to 3000 Hz. The reason is that at currents below 500 Hz, the subcutaneous nociceptors react more strongly and transmit pain to the center, and at frequencies above 8000 Hz, muscle contraction can no longer follow each stimulation pulse. This is because it will be in a state of contracting for a long time.

  In the dry mouse treatment apparatus according to the present invention, the dry mouse treatment frequency is 10 to 100 Hz, preferably 20 to 80 Hz, and more preferably 30 to 60 Hz. The reason why the frequency band is set to 10 to 100 Hz is that this frequency band can most strongly react the receptor related to salivary secretion, and is judged to be the most effective stimulation region of the submandibular gland and sublingual gland.

  In the dry mouth treatment apparatus according to the present invention, the current output from the paired electrodes may be 1 to 10 mA (effective value when a 500Ω load resistor is connected). Preferably, it is 2-9 mA, more preferably 4-8 mA. This is because when the voltage is lower than 1 mA, the current does not reach the submandibular gland and sublingual gland, while when the voltage is higher than 10 mA, the submandibular gland and sublingual gland are excessively stimulated. become. The stimulus may be a stimulus at a level that is one step lower than the intensity at which the person to be treated was able to perceive a sense of stimulation by the stimulus.

  In the dry mouse treatment apparatus according to the present invention, the output from the paired electrodes is output for 3 to 20 minutes. The number of times is 1 to several times a day, the period is 1 to 2 days or more, and it may be a treatment every other day, a daily treatment, and / or a continuous treatment.

  Four electrodes are used on the lower jaw to sandwich the submandibular gland and sublingual gland, plus and minus poles can be affixed in an X shape, and they are not larger or smaller than necessary, and are affixed. Any thin material that does not cause a sense of incongruity in the state, has high adhesion to the skin, and is flexible may be used.

  If the electrode is uncomfortable in sticking, it will affect long-term use, and if the degree of adhesion is low and the adhesion is uneven among the total of four electrodes, the electrical resistance through the skin will be poor. Since the current becomes uniform, there is a possibility that a desired current cannot be passed.

  In addition, the control unit only needs to be able to control the electrical output within each setting range in the present invention described above, but it is desirable that the control unit be small and light so that the patient can always wear it. That is, the electrode and the control unit may be connected by a cord, and the control unit may be used by being inserted into a patient's pocket or the like.

  Furthermore, an adjustment knob that enables output adjustment and a display unit that can monitor the current setting may be provided in the control unit as appropriate. Furthermore, it is good also as a structure which monitors and displays the amount of saliva secretion per unit time so that a pulse may be measured and monitored.

Hereinafter, experiments conducted for confirming the effects of the present invention will be described.
The experiment was conducted under the following conditions.

  The effectiveness of the salivary gland stimulation effect and the dry mouse treatment effect by interference waves in three types of subjects was confirmed. Three types of subjects are young subjects (20 people) who are 20-30 years old who are not taking drugs (shown as young people in the figure), and those who are 50-90 years old who are not taking drugs that reduce salivation Elderly subjects (shown as elderly in the figure) (18 persons), Saxon test (measurement of saliva secretion by chewing gauze: reference value 2 g / 2 min) of a patient who visited our hospital complaining of dry mouth Those who have saliva of 2 g / 2 min or less, except those with Sjögren patients, head and neck cancer patients, and those undergoing chemotherapy for cancer, are dry mouse patients (21 persons) (described as dry mice in the figure). did. We excluded those who had obvious cognitive impairment from the subjects, those with ataxia and dyskinesia, and those with a history of at least two aspiration pneumonia or suffocation in the past six months. In this test, the above-mentioned requirements were set as treatment subjects in order to confirm the effects. However, the dry mouse treatment apparatus according to the present invention can be widely applied to patients with dry mouse diseases.

  The electrodes were affixed to the test subject with two pairs of electrodes having positive and negative poles so as to form a cross in the lower jaw so as to sandwich the submandibular gland and the sublingual gland (FIG. 1A). The subject wore an eye mask in the eye and a noise-canceling headphone in the ear to exclude other stimulation conditions. The posture at the time of measurement was a sitting position, the head was fixed with a headrest, the hand was placed on the armrest, and the sole was seated so that the sole touched down.

  The interference wave was output with carrier frequencies of 2000 Hz and 2050 Hz, and a treatment frequency (beat frequency) at this time of 50 Hz. For the interference wave stimulation, a device that can be set in 12 levels from 0 V to 10 V was used, and each subject was stimulated with a value that was one level lower than the intensity at which each subject was able to perceive a sense of stimulation. In order to evaluate the stimulation intensity for each experimental day, the stimulation current value was recorded.

  There are two treatment conditions: a condition in which the submandibular gland and sublingual gland are stimulated with an interference wave for 15 minutes, and a condition in which the stimulation is not actually stimulated with an interference wave only by applying electrodes. Was random. Salivary cotton (Sarstedt K.K., Tokyo, Japan) was used to collect saliva. Salivet cotton was placed under the tongue and explained in advance to subjects so as not to chew or lick. In addition, the subject performed the detention / removal of the sarivet cotton. The sarivet cotton placed under the tongue was changed every 7.5 minutes. After collecting saliva, I asked the Visual Analog Scale to fill out "Pain" and "Pleasure / Uncomfortable". Saliva cotton from which saliva was collected was placed in a container and weighed, and the amount of saliva secreted by the subject was determined in advance from the difference in the container weight including the salivette cotton. The collected saliva was centrifuged (4000 rpm, 5 minutes), 100 μL of the supernatant was dispensed into an Eppendorf tube, the weight was measured, and the sample was stored frozen. The concentration of chromogranin A (CgA) in saliva, a stress marker, was quantified by ELISA (YK070 Human Chromogranin A EIA, Yanaihara research institute, Fuji, Japan). Salivary chromogranin A has attracted attention as a new indicator that reflects the sympathetic nervous system, and reports have recently been published as a marker that reflects relatively weak stress. The salivary CgA concentration was corrected by the total protein concentration (Bio-Rad Protein Assay Dye Reagent Concentrate, Bio-Rad, CA, USA) and expressed as the molar concentration (mol / mg) per total protein.

  Treatment was performed according to the protocol of FIG. 1B. Measurements were taken at the same time for two consecutive days, avoiding fullness. Treatment subjects performed a Saxon test on a different day from the experiment. Collect saliva at rest as an initial value, complete preparation by placing electrodes, determining stimulation current, wearing eye mask and headphones, inserting salivat cotton for saliva collection into oral cavity, and stimulating interference wave for 15 minutes Was treated. Salivette cotton was replaced at the midpoint. This treatment was performed for 2 days and analyzed with the data on the second day.

Table 1 shows the outline of the subjects, the results of the saxon test, and the difference in saliva volume depending on the experiment date.
Dry mice had a wide age range and many female patients. Moreover, the dry-mouse patient used as the object of this treatment had a salivary secretion amount of 1/2 to 1/3 in the Saxon test as compared with the elderly group and the youth group. The perceived current was about 1.0 mA, which was a low value in all three groups. The current during the interference wave stimulation was 1 mA, which was lower than that of a general neuromuscular electrical stimulation device (4.5 to 25 mA).

  The change in saliva volume due to the interference wave stimulation is shown in FIG. In the dry mouse patients, salivary volume was significantly increased by interference wave stimulation (P = 0.03), but there was no significant difference between youth and the elderly. The amount of saliva secreted by stimulation for 15 minutes was as low as about 1 gram in dry mice with and without interference wave stimulation. In the elderly group and the youth group, no stimulation resulted in more saliva than stimulation.

  FIG. 3 shows changes in the VAS value and CgA upon interference wave stimulation. The VAS value was less than 10% of those with pain and discomfort exceeding 10 for both with and without interference wave stimulation, and there was no significant difference compared with the presence or absence of interference wave stimulation. It was shown that the sense of discomfort was low. In addition, CgA in saliva was not significantly different from the presence or absence of interference wave stimulation, indicating that the stress due to interference wave stimulation was extremely low.

  From the above results, a significant difference was observed between the subject and the case where the present invention was not implemented. In addition, none of the subjects could recognize that they switched between a pattern in which the present invention was implemented and a pattern that did not. In addition, the specific reaction with respect to the irritation | stimulation for every test subject did not appear, and the difference in the time series with respect to irritation | stimulation was not seen. There was no pain or discomfort due to interference wave stimulation. In the dry mouse patient group, salivary secretion increased due to interfering wave stimulation on the submandibular gland, but there was no similar phenomenon in healthy subjects. It was confirmed that multiple interference wave stimulations are necessary for saliva secretion by interference wave stimulation.

The electrode sticking part to a test subject is shown. Test protocol Changes in saliva volume by interference wave stimulation Changes in VAS and CgA during interference wave stimulation

Claims (3)

  An apparatus for treating dry mouth, characterized by stimulating the submandibular gland and the sublingual gland with an interference wave percutaneously.   For stimulation of the submandibular gland and sublingual gland, two pairs of electrodes having a positive and a negative pole are placed in the lower jaw and the frequency of these two pairs of electrodes is set to 500 to 8000 Hz. The device for dry mouth treatment according to claim 1, further comprising means capable of setting a frequency difference between 10 to 100 Hz and further outputting these electrodes for 1 to 20 minutes.   3. The dry-mouse treatment device according to claim 1, wherein the pair of electrodes can be attached in an X shape to the lower jaw and is a thin and flexible electrode.