Iontophoretic anesthesia apparatus

Abstract

To provide an ion permeation type surface anesthesia apparatus capable of surely performing surface anesthesia in a shorter time.SOLUTION: The iontophoresis device 100 is provided with a sealed type ion electrode 10 equipped with an electrode part 11 filled with a surface anesthetic and a sealing ring 15 provided on the outer periphery of the electrode part 11 for preventing the surface anesthetic filled in the electrode part 11 from flowing out, a counter electrode installed in the mouth, and an ion introduction device 30 for generating ions in the electrode part 11.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to an iontophoretic topical anesthesia device. [Background technology]

[0002] The most frequently used type of anesthesia in dental treatment is a type of local anesthesia called wet anesthesia, in which an anesthetic is injected into the gums near the area to be numbed. With wet anesthesia, the injected anesthetic penetrates into the alveolar bone that supports the teeth, reaching the nerves of the teeth and exerting its effect. For this reason, this anesthesia method is used as an essential anesthesia method in common dental treatments such as tooth extractions and cavity treatments.

[0003] However, despite the usefulness of this anesthesia method, when the anesthetic is injected, patients experience a sharp pain and discomfort, which can be very stressful for them. In addition, in dental treatment for elderly people and those with medical conditions, which has increased significantly in recent years, it is important to reduce pain and fatigue caused by the anesthesia procedure itself in order to reduce the burden on patients.

[0004] Therefore, as a means of reducing pain and discomfort during dental anesthesia, one method is to apply a local anesthetic via transdermal absorption before administering a local anesthetic injection, thereby reducing the pain and discomfort of the injection. This method involves applying a topical anesthetic to the gums to numb the surface of the gums and alleviate the pain of the anesthetic injection. There are various types of topical anesthetics, including those soaked in gauze or cotton that are applied to the gums, those in a jelly form that is applied, and those in the form of a sticker that is stuck to the gums. Each type has slight differences in the range of anesthetic effect and the time it takes for the anesthetic to take effect, but generally, they are applied to the patient's gums, waited a few minutes, and then the anesthetic is injected, reducing the pain of the needle insertion.

[0005] However, in actual treatment, it is necessary to constantly pay attention to the condition of the oral cavity so that the anesthetic is not diluted by the intrusion of saliva or the seepage of mucus. Furthermore, because the penetration depth of the topical anesthetic is extremely shallow, careful attention must be paid to the angle at which the anesthetic needle is inserted and the speed of injection. This is time-consuming, and since administering topical anesthesia does not completely eliminate pain, many dentists do not use topical anesthesia for reasons of efficiency. Summary of the Invention [Problem to be solved by the invention]

[0006] Therefore, the present invention has been made to solve the above problems, and has as its object to provide an iontophoretic surface anesthesia device that can reliably perform surface anesthesia in a shorter time. [Means for solving the problem]

[0007] In order to achieve the above object, the present invention employs the following means.

[0008] The iontophoretic surface anesthesia device of the present invention comprises: a sealing-type ion electrode including an electrode portion filled with a surface anesthetic and a sealing ring provided on the outer periphery of the electrode portion to prevent the surface anesthetic filled in the electrode portion from flowing out; A counter electrode placed in the mouth; an iontophoresis device that generates ions at the electrode portion; Equipped with The positive electrode of the iontophoresis device is connected to the electrode portion, and the negative electrode is connected to the counter electrode.

[0009] The iontophoretic surface anesthesia device of the present invention can achieve an anesthetized state extremely quickly, within one to one and a half minutes. This is because, instead of applying a surface anesthetic to the gums, a sealing ring filled with a gel-like anesthetic can be used to block the penetration of saliva and mucus from the oral cavity. Furthermore, rather than contacting the surface anesthetic with the mucosal surface, the gel-like surface anesthetic is pressed against the mucosal surface, rubbing it in, thereby accelerating penetration. Furthermore, by using an iontophoresis device to pass a weak current through the mucosal surface, a one-way electrical flow can be created, temporarily loosening the barrier function, allowing the active ingredients of the drug to penetrate through the barrier zone and into the mucosa.

[0010] In the iontophoretic surface anesthesia device according to the present invention, the sealing ring may preferably be a silicone tube.

[0011] Furthermore, in the iontophoretic surface anesthesia device according to the present invention, the blocked ion electrode may be formed into a circle having a diameter of 6 mm to 8 mm. By administering surface anesthesia to this area, pre-anesthesia can be administered to an area that is effective when administering moist anesthesia by injection.

[0012] Furthermore, in the iontophoretic surface anesthesia device according to the present invention, the blocked ion electrode may be provided with a magnet. By attaching a magnet, a magnetic field is passed through the output current, adding an Ampere force and further improving the penetration force. [Effects of the Invention]

[0013] The iontophoretic surface anesthesia device of the present invention can induce an anesthesia state extremely quickly, within 1 minute to 1 minute and 30 seconds. [Brief explanation of the drawings]

[0014] [Figure 1] FIG. 1 is a conceptual diagram of an iontophoretic surface anesthesia device 100 according to an embodiment. [Figure 2]Fig. 2A is an enlarged view of the blockage ion electrode 10 of the iontophoretic surface anesthesia device 100 according to the embodiment. Fig. 2B is an enlarged view showing the blockage ion electrode 10 with the blockage ring 15 removed. [Figure 3] FIG. 3 is an enlarged view showing a state in which a magnet is provided on the blockage type ion electrode 10 of the iontophoretic surface anesthesia device 100 according to the embodiment. [Figure 4] FIG. 4 is a conceptual diagram showing the iontophoretic surface anesthesia device 100 according to the embodiment in use. DETAILED DESCRIPTION OF THE INVENTION

[0015] Next, an embodiment of an iontophoretic surface anesthesia device 100 according to the present invention will be described in detail with reference to the drawings. Fig. 1 is a schematic diagram of an iontophoretic surface anesthesia device 100 according to an embodiment. Note that the embodiments and drawings described below exemplify some of the embodiments of the present invention, and the present invention is not limited to these configurations, and can be modified as appropriate without departing from the gist of the present invention.

[0016] First, the concept of the anesthesia method using the iontophoretic surface anesthesia device 100 according to the present invention will be explained.

[0017] The anesthesia method using the iontophoretic surface anesthesia device 100 of the present invention relates to surface anesthesia that is administered before administering an injection anesthesia, particularly in dental treatment. This corresponds to pre-anesthesia that is administered before administering an injection anesthesia.

[0018] Human skin and mucous membranes have a barrier function that protects the body from the intrusion and irritation of foreign substances from the outside world. They protect the body from dryness, external stimuli, foreign substances, and ultraviolet rays, and also prevent moisture from evaporating from the body. Skin and mucous membranes have a three-layer structure. This barrier function is particularly mediated by the epidermis in skin and the mucosal epithelium in mucous membranes. Penetrating this barrier and allowing drugs to penetrate is not easy. Transdermal drugs utilize the selective absorption of substances through the skin surface and mucosal epithelium. Surface anesthetics contain several transdermal drug bases, but they are not very permeable. Despite the distribution of peripheral nerve branches close to the mucosal surface, the onset of surface anesthetic effects takes 3–5 minutes or more, and even simple anesthetic procedures require 10 minutes or more before transitioning to the next treatment. Furthermore, reliable anesthetic effects are not guaranteed. Despite pain relief, discomfort and mild pain often remain upon needle insertion. These factors have been sufficient to discourage practical use.

[0019] Therefore, in order to ensure a more reliable surface anesthetic effect, the present invention proposes an iontophoretic surface anesthetic device 100 that can perform an anesthesia method using iontophoresis, which has a penetration rate of approximately 30 to 70 times, rather than the conventional anesthesia method that relies on transdermal absorption.

[0020] Iontophoresis is a typical drug delivery system that can deliver drugs quantitatively into the skin without damaging the skin or mucous membranes. Iontophoresis involves passing a weak electric current through the skin and mucous membranes, allowing water-soluble anesthetics to penetrate the body painlessly. It maintains sufficient local drug concentrations while achieving 30 to 70 times greater penetration than conventional topical injection. When electric current is passed through the human body, an electric field is generated between electrodes in every part of the body, passing through the tissue. In this electric field, positive ion molecules are attracted to the cathode, and negative ion molecules are attracted to the anode, causing the movement of charged particles within the tissue affected by the electric field (electrophoresis). If the amount of current (current multiplied by the duration of current flow) is sufficient, the charged particles will move within the tissue, and if the charged particles are anesthetics, the direct current acts as a carrier for their introduction. Topical anesthesia medicine(Since water with a pH of 3.0 to 4.5 carries a positive charge, when a weak positive current is passed through it, the charges repel each other and penetrate into the skin or mucous membranes.

[0021] Iontophoresis is an evidence-based physical drug transdermal absorption enhancement method that uses a weak electrical current to promote the penetration of small molecule drugs. It is also known as electromigration across the skin and mucous membranes. The surface of the skin and mucous membranes is slightly acidic, while the deeper layers are slightly alkaline. This boundary forms an electrical barrier zone, preventing the penetration of foreign substances while creating an environment that makes it difficult for active ingredients such as pharmaceuticals to penetrate. Conventional pharmaceuticals and cosmetics penetrate only up to this point. When an iontophoresis device is used, it blocks the flow of current through the stratum corneum and granular layer, allowing the active ingredients of pharmaceuticals to pass through the barrier zone and reach the deeper layers of the skin. Then, by passing an electric charge identical to that of an anesthetic, the ingredients are pushed by electrical repulsion, penetrating the skin's barrier zone and penetrating deeper. This is how iontophoresis works.

[0022] Next, we will explain the iontophoretic surface anesthesia device 100 according to the present invention. As shown in Figure 1, the iontophoretic surface anesthesia device 100 mainly comprises an electrode portion 11 (see Figure 2B) filled with a surface anesthetic and a blockage-type ion electrode 10 equipped with a blockage ring 15 for preventing the surface anesthetic applied to the electrode portion 11 from flowing out, a counter electrode 20 placed in the mouth, an iontophoresis device 30 that generates ions in the electrode portion 11, and an electric wire 60 that electrically connects these.

[0023] The sequestering ion electrode 10 is filled with a surface anesthetic and is used to infiltrate the surface anesthetic into the mouth before administering an injection anesthesia such as moist anesthesia. The sequestering ion electrode 10 is made of a conductive plate, preferably a circular plate made of 18K platinum-gold, to efficiently transmit current to the mucosa. The sequestering ion electrode 10 is preferably made into a circular shape with a diameter of approximately 6 mm to 8 mm, which is large enough to administer an injection anesthesia while allowing efficient ion penetration. The sequestering ion electrode 10 also includes a sealing ring 15 to prevent the surface anesthetic encapsulated around it from leaking out, to block the intrusion of saliva and mucus in the oral cavity, and to prevent dilution of the surface anesthetic. The sealing ring 15 has a cylindrical wall surface surrounding the sequestering ion electrode 10. A ring made of silicone is preferably used. Silicon has a moderate softness, is less painful when pressed into the oral cavity, and effectively prevents the intrusion of saliva and mucus. As shown in Figure 3, a magnet 50 can be attached to the blocked ion electrode 10, which allows the output current to pass through a magnetic field, adding an Ampere force and further improving the penetration force. The blocked ion electrode 10 has a long, rod-shaped handle 12 that makes it easy to apply a topical anesthetic to the inside of the mouth.

[0024] The counter electrode 20 is attached to the mouth during treatment. Preferably, it is attached to a hook as shown in Figure 1 to make it easier to place inside the mouth. By creating it in this way, the counter electrode 20 can be attached to the mouth simply by hooking the clip onto the corners of the lips.

[0025] The iontophoresis device 30 is a device that applies a weak positive current to a topical anesthetic, and the positive electrode is connected to the blocked ion electrode 10 via an electric wire 60, and the negative electrode is connected to the counter electrode 20. The positive electrode of the iontophoresis device 30 is connected to the electrode unit 11, and the negative electrode is connected to the counter electrode 20.

[0026] The iontophoretic surface anesthesia device 100 configured as described above is used as follows. First, a jelly-like surface anesthetic is filled into the blockage ion electrode 10 equipped with the blockage ring 15 shown in FIG. 2A. After filling with the jelly-like surface anesthetic, when the blockage ion electrode 10 is pressed against the gums, a cotton nonwoven fabric impregnated with Bosmin is sandwiched between the blockage ion electrode 10 and the surface anesthetic to prevent the blockage ion electrode 10 from directly contacting the gum mucosa. While lidocaine is preferably used as the surface anesthetic, this is not a limitation. A surface anesthetic with a concentration of 20% or higher is preferably used. Furthermore, a surface anesthetic used for iontophoresis preferably contains adrenaline. As shown in FIG. 4, the blockage ion electrode 10 filled with the surface anesthetic is pressed against the inner surface of the oral cavity so that the blockage ring 15 contacts the surface anesthetic at the location where injection anesthesia is to be administered.

[0027] Meanwhile, the counter electrode 20 is attached to the corners of the lips using a metal fitting, and the negative electrode is attached so that it is sandwiched between the cheek and the buccal surface of the dentition. The iontophoretic surface anesthesia device 100 of the present invention facilitates electrophoresis of charged particles by reducing the current-carrying loop, eliminating the need for the patient to hold a handheld electrode during treatment. In this state, the iontophoresis device 30 is turned on. The output current is adjusted to a pain-free range. Because the amount of drug transport is proportional to the current, the output current is preferably adjusted to 500 μA to 1000 μA. Because surface anesthetics carry a positive charge, applying a weak current repels the blocked ion electrode 10, resulting in iontophoresis of the surface anesthetic into the negatively charged skin and mucosa that serve as the counter electrode. The surface anesthetic introduction time is generally approximately 1 to 1 minute 30 seconds, but this can be adjusted slightly depending on the area and the presence or absence of inflammation. After a predetermined time has passed, the effectiveness of the anesthesia is confirmed by a cold pain test using air or by using an electric needle, and then anesthesia treatment is administered by needle injection.

[0028] The reason why the iontophoretic surface anesthesia device 100 can achieve an anesthetized state extremely quickly, in one to one and a half minutes, is due to the method of applying a surface anesthetic to the oral mucosa.

[0029] The usual method involves soaking a gauze or cotton pad with a topical anesthetic ointment (jelly) or spray and placing it on the patient's gums. After the topical anesthetic has taken effect, the patient is given an injection, which reduces the pain of needle insertion. However, the anesthetic only reaches the surface of the mucosa, not the deeper layers. In anesthesia using the iontophoretic topical anesthesia device 100 of the present invention, the topical anesthetic is not applied to the gums; instead, a jelly-like topical anesthetic is loaded into the electrode and the surrounding silicone ring (blocking ring 15) (blocking ion electrode 10). This silicone ring (tube) prevents the electrode from being pressed against the gums, preventing the penetration of saliva and mucus from the oral cavity and preventing the topical anesthetic from diluting. Furthermore, pressing the loaded topical anesthetic against the mucosal surface allows the jelly-like topical anesthetic to be rubbed into the mucosa, allowing the topical anesthetic to penetrate quickly.

[0030] Mucosal surfaces also possess several barrier mechanisms that prevent foreign substances from entering the body. The surface of the skin or mucous membrane is weakly acidic, while anything below that is weakly alkaline. This boundary forms the electrical barrier zone. Therefore, by using iontophoresis to pass a weak current across the mucosal surface, a one-way electrical flow is created, causing the stratum corneum and granular layer to become neutral, temporarily relaxing the barrier function. The active ingredients of the drug pass through the barrier zone and penetrate into the mucous membrane. The surface anesthetic used in this study has a high concentration of anesthetic, exceeding 20%, and relaxing the barrier function also creates a concentration gradient for transdermal drug delivery, allowing for deep penetration and diffusion into the mucous membrane.

[0031] Surface anesthesia sites are divided into non-keratinized bicarbonate squamous epithelium, which is said to cause relatively little pain when an injection needle is inserted into subcutaneous tissue and submucosal tissue such as the oral basal vestibule, buccal mucosa, and alveolar mucosa, and keratinized bicarbonate squamous epithelium, which is said to cause pain when an injection needle is inserted into the attached gingiva and hard palate mucosa, which are keratinized, immobile, lack subcutaneous tissue, and are directly connected to bone.

[0032] The oral vestibule and cheek mucosa area, known as the gingival-buccal junction, is said to be relatively painless, but it is a surprisingly narrow and mobile area, so the electrodes that are in contact with it are prone to slipping off and will not remain in a stable position unless they are firmly grasped.

[0033] In addition, the buccal area exudes more saliva and mucus than the lingual and palatal sides, and even if the surface anesthesia procedure is performed in a silicone-shielded environment, once the anesthesia machine is removed, the area is immediately covered with exudate, and the 7mm diameter electrode site is easily lost. Therefore, it is necessary to perform infiltration anesthesia immediately while the surface anesthesia site can still be clearly identified.

[0034] On the other hand, the surface anesthesia effect of the iontophoretic surface anesthesia device 100, which is used as a pretreatment for local anesthetic injection, is not limited to injection sites such as the oral vestibule and cheek mucosa, which are said to be relatively painless, but also to the keratinized, immobile attached gingiva and hard palate mucosa, which are said to cause pain when a needle is inserted.It was found that the sensation of insertion of the needle after iontophoresis is the same, and there is no discomfort during the subsequent injection of the anesthetic.

[0035] The sensation of the needle being inserted after one minute of iontophoretic topical anesthesia using the iontophoretic topical anesthesia device 100 varies somewhat from person to person, depending on one's image of and experience with anesthetic injections. Of course, some patients report feeling nothing at all, but in many cases, when the needle is inserted, it feels like a fingertip is pressing lightly against the palm of one's hand. However, there is no discomfort during the subsequent injection of the anesthetic, and no one has reported feeling any pain.

[0036] The fact that the injection site for anesthetic injection using the iontophoretic surface anesthetic device 100 of the present invention is all mucous membranes, including the hard palate, breaks away from the conventional concept that moist anesthesia is administered in areas with well-developed subcutaneous tissue and submucosal tissue, such as the oral vestibule, cheek mucosa, and alveolar mucosa.

[0037] Therefore, due to their morphological characteristics, it is difficult to maintain a stable surface anesthetic in place on the lingual or palatal side, and these areas have not been used frequently. This indicates that the anesthesia range provided by ionic surface anesthetic devices can be applied to all oral mucosa, including the hard palate. The ability to select the anesthetic injection site for dental treatment from the lingual or palatal side, rather than only from buccal sites such as the oral vestibule and buccal mucosa, provides greater flexibility and improves the quality of treatment. This allows for flexible response, such as switching to the lingual side when inflammation is present on the buccal side. For example, when anesthetizing a molar in a female patient, if the buccal mucosa seems too close and the space seems cramped, we do not hesitate to switch to the lingual or palatal side. Furthermore, anesthesia from these sites appears to be more effective than anesthesia from the buccal side because it is closer to the bone surface.

[0038] The fact that the injection site for anesthetic injection using the iontophoretic surface anesthetic device 100 can now be all mucous membranes, including the hard palate, breaks away from the conventional concept that moist anesthesia is administered in areas with well-developed subcutaneous tissue and submucosal tissue, such as the oral vestibule, cheek mucosa, and alveolar mucosa.

[0039] As described above, iontophoretic anesthesia using the iontophoretic surface anesthesia device 100 of the present invention allows for selective anesthesia, enabling the concentrated delivery of a surface anesthetic to a specific area or nerve. This allows for anesthesia at a specific location. Furthermore, compared to conventional surface anesthesia methods that rely on transdermal absorption, iontophoretic anesthesia provides an anesthetic effect extremely quickly, occurring in approximately 1 to 1.5 minutes.

[0040] In addition, with conventional topical anesthesia methods, gauze or cotton rolls must be placed in the mouth to block saliva and prevent the surface anesthetic applied to the gums from flowing away, while maintaining the anesthetic for 3 to 5 minutes until it takes effect. However, while this task may seem simple, it is actually quite difficult. Because of the exudation of not only saliva but also mucus, constant attention must be paid to the condition of the oral cavity to prevent the surface anesthetic from being diluted, as well as to the dryness of the oral cavity, making it difficult to maintain the desired level of anesthetic. However, with the iontophoretic surface anesthesia device 100 of the present invention, the surface anesthetic is not applied to the gums, but is instead loaded into a blocked iontophoretic electrode. This reduces the amount of anesthetic used to approximately 10% to 20% of that required when the anesthetic is applied directly to the gums. [Industrial Applicability]

[0041] As shown in the above-described embodiment, the present invention can be industrially utilized as a dental treatment tool. [Explanation of symbols]

[0042] 10...blocked ion electrode, 11...electrode portion, 15...blocking ring, 20...counter electrode, 30...iontophoresis device, 60...electric wire, 80...S-shaped hook portion, 100...iontophoresis type surface anesthesia device

Claims

1. a sealing-type ion electrode including an electrode portion filled with a surface anesthetic and a sealing ring provided on the outer periphery of the electrode portion to prevent the surface anesthetic filled in the electrode portion from flowing out; A counter electrode placed in the mouth; an iontophoresis device that generates ions at the electrode portion; Equipped with An iontophoretic surface anesthesia device, characterized in that the positive electrode of the iontophoresis device is connected to the electrode portion, and the negative electrode is connected to the counter electrode.

2. 2. The iontophoretic surface anesthesia device according to claim 1, wherein the sealing ring is a silicone tube.

3. 2. The iontophoretic surface anesthesia device according to claim 1, wherein the blocked ion electrode is formed in a circular shape with a diameter of 6 mm to 8 mm.

4. 4. The iontophoretic surface anesthesia device according to claim 1, wherein the blockade type ion electrode is provided with a magnet.

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