JPWO2008023799A1 - Mandibular frontal oral cavity connector for sleep apnea syndrome or snoring improvement - Google Patents

Abstract

Simple, inexpensive, easy to install on the splint in a short time, and easy to change and repair the mandibular position after installation. A device connector is provided. Either one of the axial end portions 1A, 1B is an adhesive portion to the maxillary splint 50A, and the other is an adhesive portion to the mandibular splint 50B, and the both ends 1A, 1B are bonded to the maxillary or mandibular splint. A flexible band 1 having a plurality of convex teeth (convex teeth row) 12 formed on the surface, and caps 20 respectively covering both ends 1A and 1B of the flexible band 1; Adhesive 30 is attached to the vicinity of the canine portion of upper jaw splint 50A together with cap 20 with one end portion 1A covering the end portion, and large portion of lower jaw splint 0B together with cap 20 covering the other end portion 1B with the end portion. It is set as the structure adhere | attached with an adhesive agent around a molar part.

Description

  The present invention relates to a connector for a mandibular frontal oral cavity device that improves sleep apnea syndrome or snoring, and in particular, can be attached to a splint with a simple configuration without requiring a joint to be embedded in the splint. The present invention relates to a connector for a mandibular frontal oral appliance that improves sleep apnea syndrome or snoring.

  Sleep apnea syndrome is a disease in which breathing stops during sleep (apnea) is repeated intermittently, and was proposed in the United States in 1976. “30 hours of apnea during 7-hour night sleep” The number of apneas / hypopneas (apnea / hypopnea index: AHI) recognized every hour or more than 5 times, and some of them can observe the most regular breathing in healthy people The definition of “when observed during sleep, called non-REM sleep” is often used. When such illness develops, it is difficult to get enough sleep, and during the daytime, lack of concentration, vitality, and a tendency to fall asleep, disturbing daily life. In the United States, it was reported that patients with this disease were involved against the background of the nuclear accident on Three Mile Island, a tanker landing off Alaska, an explosion accident immediately after the launch of the Space Shuttle Challenger, or a large trailer accident on the highway. Has been. In Japan, it has been reported that the Sanyo Shinkansen driver was associated with an illness that caused a drowsy driving. Therefore, there are concerns about the occurrence of accidents that could endanger human life if left untreated for sleep apnea syndrome, so appropriate measures such as symptom analysis, diagnosis, treatment, and prevention are required. .

  Sleep apnea syndrome is classified into “central type (CSAS)” in which commands from the respiratory center stop, “obstructed type (OSAS)” due to upper airway stenosis or obstruction, and “mixed type” in which the central type and obstructive type are mixed. Although it is classified, the obstructive type in which the airway is physically blocked by the tongue and becomes apnea is the target of treatment by the dentist.

  In obstructive (OSAS) patients, when lying on their back, the tongue base sinks and the upper airway narrows. During sleep, in addition to a decrease in the activity of the muscles that make up the upper respiratory tract, the pressure in the respiratory tract is reduced during inspiration, resulting in a narrower airway. appear. Snoring is caused by the flow of air through a narrow airway, and not always having apnea just because of a large snoring, but the airway is quite narrow and obstructive (OSAS) occurs. It is considered easy.

  Sleep splint is a common name for the mandibular frontal oral appliance (PMA) and is used to prevent snoring and to treat moderate to mild obstructive sleep apnea syndrome (OSAS). Most sleep disordered breathing associated with snoring or upper airway obstruction is caused by the relaxation of the tongue muscle, especially the genioglossus muscle during sleep, and the tongue falls back, constricting the airway with the relaxed pharyngeal side wall, the soft palate posterior region, and the uvula Or it is thought to be caused by obstruction. A sleep splint is an improvement of upper airway obstruction and snoring by positioning the lower jaw and tongue forward and dilating the upper airway during sleep. Many details of this mechanism have not been clarified, but by positioning the mandible forward relative to the maxilla, the genioglossus muscle attached to the inner surface of the mandible develops, and the tongue is also pulled forward accordingly. , Upper airway is thought to expand.

  The sleep splint consists of parts to be attached to the upper jaw (maxillary splint) and parts to be attached to the lower jaw (mandibular splint), and the upper and lower parts are connected to each other at the position where the airway during sleep is secured (ie, the lower jaw front). . There are two types of connection methods: a method of fixing the upper and lower parts and a movable connection method that allows a certain degree of movement such as opening and closing while keeping the lower jaw in the forward orientation. The fixed type does not require parts for connection, and the connection operation is easy, but because the lower jaw is fixed during sleep, the feeling of wearing is inferior and the burden on the temporomandibular joint is also a concern . Therefore, a method of movably connecting the upper and lower parts (sprints) of the sleep sprint has been devised, and many devices have been reported. In the US, some FDA (Food & Drug Administration) has already approved it as effective for snoring and obstructive sleep apnea syndrome (OSAS).

  Many of these movable sleep splints take the method of (1) pushing forward, (2) pulling forward, or (3) hooking with a hook, with the upper jaw as a fulcrum, to hold the lower jaw in the forward orientation. ing. (1) In the method of pushing forward, the maxillary molar portion and the mandibular front tooth portion are connected, and a metal material having high rigidity against compression is used for the connecting means. (2) In the method of pulling forward, the maxillary anterior teeth and mandibular molars are connected, and the connecting means does not require much rigidity, so a resin material is also used in addition to metal. (3) In the case of using the method of hooking with a hook, both the hook and the receiving part are made of metal. Specifically, for example, in a device manufactured by Scheu-Dental (sales Co., Ltd., Morita), a hook fixed to the upper part (maxillary sprint) is hooked on the wire of the front teeth of the lower part (maxillary sprint). The "silencer" (product name) manufactured by Elcodent (sales: Nippon Dental Supply Co., Ltd.) has a canine and lower part (lower jaw) for the upper part (upper jaw sprint). Jonito is embedded in the molar part of the splint in advance, and the connecting member is fastened to the joints of these upper and lower parts. In Patent Document 1 below, hooks are attached to the vicinity of the molar teeth of the canine portion and the lower jaw splint of the maxillary splint, and elastic bands such as rubber bands are removably hooked and fixed to these hooks. Proposed. The movable range of the lower jaw of the movable sleep splint is generated by the hinge movement of the joint portion between the splint and the connecting member, the elasticity of the sheath-like instrument, or the play of the hook and the receiving portion.

However, the above-described conventionally known movable sleep splints (that is, the mandibular front-orientation type intraoral device) are both joints for previously connecting the connecting members to the upper and lower parts (maxillary splint and mandibular splint) Hooks have to be embedded and fixed (that is, joints have to be created), and the production of the joints is complicated and cumbersome. There is a problem that it takes. In addition, the number of parts required for the whole connecting means including the joint portion is not small, and the price of each part cannot be said to be low, and there is a problem that the cost increases. There is also a problem that the mandibular position cannot be easily changed or repaired. Furthermore, since the sprint is designed to include the connecting means, the connecting means cannot be applied to the already-used fixed-type sprint (that is, the connecting means is attached later to the existing sprint). Is not possible).
JP 2004-73473 A

  In view of the above circumstances, an object of the present invention is a movable mandibular front azimuth that is simple and inexpensive in configuration, can be easily and quickly mounted on a splint, and can be easily changed and repaired after the mounting. It is to provide a connector for a mandibular frontal oral cavity device that improves sleep apnea syndrome or snoring, which can realize a type oral device.

In order to solve the above problems, the present invention has the following features.
(1) A connector for connecting an upper jaw and a lower jaw splint made of a resin or elastomer mold to a state in which the upper jaw and the lower jaw can be opened and closed while keeping the lower jaw in the forward orientation,
Either one of the axial ends is the adhesive part to the maxillary splint, and the other is the adhesive part to the mandibular splint. A flexible band forming a dentition);
A cap that covers each end of the flexible band;
Adhering the upper end of the flexible band together with the cap covering the end portion of the flexible band with an adhesive, and the molar portion of the lower splint together with the cap covering the other end portion of the flexible band A connector for a mandibular frontal oral cavity device that improves sleep apnea syndrome or snoring, and is configured to adhere to the vicinity by an adhesive.
(2) The connector for a mandibular front-orientation type oral cavity device for improving sleep apnea syndrome or snoring according to the above (1), wherein the cap is formed of a nail-like member having a recess fitted to the end of the flexible band. .
(3) The connector for a mandibular frontal oral cavity device for improving sleep apnea syndrome or snoring according to the above (1) or (2), wherein the flexible band is a polyethylene band.
(4) The upper jaw splint is a polycarbonate mold, the lower jaw splint is an acrylic resin mold, the flexible band is a polyethylene band, the cap is an acrylic resin cap, and the adhesive is a dental room temperature polymerization resin The connector for a mandibular frontal oral cavity device for improving sleep apnea syndrome or snoring according to the above (1) or (2).
(5) A connector for connecting an upper jaw and a lower jaw splint made of a resin or elastomer mold to a state in which the upper jaw and the lower jaw can be opened and closed while keeping the lower jaw in the forward orientation,
Either one of the axial end portions is an adhesive portion to the maxillary splint, and the other is an adhesive portion to the mandibular splint, and the first surface that is the side that adheres to the maxilla or the mandibular splint at both ends A first convex tooth row is formed on the second surface opposite to the first surface, and a second convex tooth row intersecting the first convex tooth row is formed on the second surface. A flexible band formed by communicating the bottom of the concave groove between adjacent convex teeth of the dentition and the bottom of the concave groove between adjacent convex teeth of the second convex dentition;
By adhering one end of the flexible band near the canine part of the maxillary splint with an adhesive, and adhering the other end to the vicinity of the molar part of the mandibular splint using an adhesive, The adhesive is embedded in the concave groove between adjacent convex teeth of the first convex tooth row and the concave groove between adjacent convex teeth of the second convex tooth row at the end of the flexible band. A connector for a mandibular frontal oral appliance that improves sleep apnea syndrome or snoring.
(6) The connector for a mandibular front-orientation type intraoral device for improving sleep apnea syndrome or snoring according to the above (5), wherein the flexible band is a polyethylene band.
(7) The upper jaw splint is a polycarbonate mold, the lower jaw splint is an acrylic resin mold, the flexible band is a polyethylene band, and the adhesive is a dental room temperature polymerization resin. A connector for an oral appliance with a mandibular orientation that improves sleep apnea syndrome or snoring.
(8) A connector for connecting an upper jaw and a lower jaw splint made of a resin or elastomer mold to a state in which the upper jaw and the lower jaw can be opened and closed while keeping the lower jaw in the forward orientation,
A thin piece member having a plurality of through holes is fixed to each of the both ends of the flexible band in which either one of both ends in the axial direction is used for bonding to the upper jaw sprint and the other is used for bonding to the lower jaw sprint. ,
The thin piece member fixed to one end of the flexible band is adhered to the canine portion of the maxillary splint with an adhesive, and the thin piece member fixed to the other end is attached to the vicinity of the molar portion of the mandibular splint with an adhesive. A connector for a mandibular frontal cavity type oral cavity device with improved sleep apnea syndrome or snoring, wherein the adhesive is embedded in a plurality of through-holes of a thin piece member by bonding with the adhesive.
(9) The connector for a mandibular frontal oral cavity device for improving sleep apnea syndrome or snoring according to the above (8), wherein the flexible band is a polyethylene band.
(10) The upper jaw splint is a polycarbonate mold, the lower jaw splint is an acrylic resin mold, the flexible band is a polyethylene band, the adhesive is a dental room temperature polymerization resin, and the flake member is made of titanium. A connector for a mandibular frontal oral cavity device for improving sleep apnea syndrome or snoring according to (8) above.
(11) The mandibular frontal oral cavity for improving sleep apnea syndrome or snoring according to any one of the above (1) to (10), wherein the adherend regions of the maxillary splint and the mandibular splint are preliminarily treated with a primer Connector for internal device.

According to the connector for the lower jaw front-orientation type intraoral device of the present invention, the movable mandibular front-orientation type can be obtained by connecting the upper jaw and the lower jaw splint by simply bonding the end of the flexible band as the connector body to the side surface of the splint. Since the intraoral device can be completed, it is easy to operate and requires less time, and the movable mandibular frontal type intraoral device can be attached to the patient on the spot.
In addition, by using a polyethylene band for the flexible band that is the connector body, the flexible band is easily deformed, and the upper and lower sprints can be moved smoothly. Furthermore, since the flexibility varies depending on the type of polyethylene, it is possible to select the degree of movement according to the case.
In addition, the structure is simple, there are few parts, the cost is low, and the cost of the mounting operation is low.
In addition, the connector for the lower jaw front-orientation type intraoral device according to the present invention is not attached to the splint when the splint (maxillary splint, mandibular splint) is manufactured. Since it is bonded later with an adhesive, it is possible to easily change or repair the lower jaw position in the movable mandibular frontal-type intraoral device.

1 is an exploded view of a connector for a mandibular frontal-type intraoral device according to a first embodiment of the present invention. It is principal part sectional drawing of the flexible band shown in FIG. It is a side view of the cap shown in FIG. It is a top view of the state which covered the cap on the edge part of the flexible band shown in FIG. It is a perspective view of the state which covered the cap on the edge part of the flexible band shown in FIG. FIG. 2 is a schematic perspective view of a movable mandibular frontal-type intraoral device in which an upper jaw splint and a lower jaw splint are connected using the connector shown in FIG. 1. FIG. 7 is a schematic plan view of a state in which the movable mandibular front-orientation type intraoral device of FIG. 6 is mounted in the oral cavity, and is a diagram in which the upper jaw and the lower jaw are closed. FIG. 7 is a schematic plan view of a state where the movable mandibular front-orientation type intraoral device of FIG. 6 is installed in the oral cavity, and is a diagram in which the upper jaw and the lower jaw are in an open state. It is a top view of the flexible band of another aspect. It is the figure which has apply | coated the adhesive agent to the edge part of a flexible band. It is a figure which shows the edge part of the flexible band in the connector for lower jaw front directional type intraoral apparatus of 2nd Embodiment of this invention, A figure (a) is a schematic diagram of a 1st plane, A figure (b) is 2nd. A schematic view of the plane, FIG. (C) is a schematic view of the side. It is explanatory drawing of the hole formed in the ditch | groove in the flexible band shown in FIG. It is a schematic perspective view of the vicinity of the end of the flexible band in the connector for the lower jaw front-facing type intraoral device of the third embodiment of the present invention. It is a schematic cross section of the principal part of Examples 1 and 2 (Samples 1 and 2). It is a schematic cross section of the principal part of the comparative example 1 (sample 3).

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Flexible band 1A, 1B End part of flexible band 12 Convex teeth row 20 Cap 30 Adhesive 50A Maxillary splint 50B Mandibular splint 100 Connector

Hereinafter, the present invention will be described in detail.
FIG. 1 is an exploded view of a connector for a sleep splint (ie, a mandibular frontal-oral-type intraoral device) according to a first embodiment of the present invention, FIG. 2 is a cross-sectional view of an essential part of the flexible band shown in FIG. FIG. 4 is a side view of the cap shown in FIG. 1, and FIG. 4 and FIG. 5 are a plan view and a perspective view showing a state where the cap is put on the end of the flexible band shown in FIG. FIG. 6 is a schematic perspective view of a movable mandibular frontal oral cavity device in which the maxillary splint and the mandibular splint are connected using the connector shown in FIG. 1, and FIGS. FIG. 7 is a schematic plan view of a state in which the device is mounted in the oral cavity. FIG. 7 is a diagram in which the upper jaw and the lower jaw are closed, and FIG. 8 is a diagram in which the upper jaw and the lower jaw are in an open state.

  The connector 100 of the first embodiment includes a flexible band 1 and two caps 20 that cover both ends of the flexible band 1.

  As described in the above-mentioned background art section, the movable mandibular frontal-type intraoral device includes an upper sprint that covers the occlusal surface of the upper dentition and a lower sprint that covers the occlusal surface of the lower dentition. It is a mandibular front-orientation type intraoral device connected so as to allow a certain amount of movement such as opening and closing while maintaining the front direction, and the connector (connector 100) of the present invention is as shown in FIGS. The ends of the flexible band 1 that is the main body of the upper and lower jaw splints 50A and 50B are coupled to the outer surfaces of the upper and lower jaw splints 50A and 50B on the left and right sides of the upper jaw splint 50A and the lower jaw splint 50B. By using this connector, the maxillary and mandibular splints are connected so that the maxilla and mandible can be opened and closed while maintaining the mandible in the forward orientation, and a movable mandibular forward orientation intraoral device is realized. That.

  The maxillary splint and the mandibular splint connected by the connector of the present invention are not particularly limited, and a splint made of a general resin or elastomer mold (molded body) produced according to conventional general materials and manufacturing methods is applied. The Specific examples include molds such as acrylic resins, polycarbonate resins, silicone resins, polysulfone resins, and polyolefin-based thermoplastic elastomers that are less harmful to the living body. In particular, from the viewpoint of alleviating discomfort during wearing, a combination in which the upper jaw splint is made of a polycarbonate mold and the lower jaw splint is made of an acrylic resin mold is preferable.

  In the connector 100 of the first embodiment, the flexible band 1 and the two caps 20 (FIG. 1) covering both ends of the flexible band 1 are also provided on the left side of the sprint (upper jaw sprint, lower jaw sprint). Also used on the right side. That is, the left and right are shared. As shown in FIGS. 6-8, the flexible band 1 is used with one of its axial ends 1A, 1B coupled to the maxillary splint 50A and the other coupled to the mandibular splint 50B. The The ends 1A and 1B are bonded to the sprint by bonding the ends 1A and 1B to the sprint with an adhesive 30. In a conventional movable mandibular front-orientation type intraoral device, joints and hooks for connecting connecting members are embedded in the sprint (upper jaw sprint, lower jaw sprint) itself (that is, a joint portion is formed in the sprint), Since the connecting member is attached to the joint and the hook to connect the upper jaw splint and the lower jaw splint, the working time is lengthened. However, in the connector of the present invention, as shown in the connector 100 of the first embodiment. In addition, since the end portions 1A and 1B of the flexible band 1 which is the connector main body are simply adhered to the surface of the splint (upper jaw splint 50A and lower jaw splint 50B), the operation is simple and less time is required. As shown in FIGS. 7 and 8, normally, one end 1A of the flexible band 1 is connected to the canine part of the maxillary splint 50A on the right and left sides of the splint (maxillary splint 50A, mandibular splint 50B). The other end 1B is bonded to the vicinity of the molar portion of the mandibular splint 50B.

  As shown in FIG. 1, the axis L2 of the surface (first surface) 11 to be bonded to the splint (upper jaw splint, lower jaw splint) of the flexible band 1 is aligned with the axis L1 of the flexible band 1. Convex tooth rows 12 (FIG. 2) in which a plurality of convex teeth 12 a orthogonal to each other are arranged in parallel are formed. In FIG. 1, the convex tooth row 12 is formed over the entire length of the surface (first surface) 11 to which the flexible band 1 is bonded, but as shown in FIG. You may form the convex-tooth row | line | column 12 only in edge part 1A, 1B used as an adhesion part. As shown in FIGS. 4 and 5, the end of the flexible band 1 to the splint of the end portions 1 </ b> A and 1 </ b> B is bonded to the splint of the end portions 1 </ b> A and 1 </ b> B. The surface (second surface) 13 opposite to the surface 11) is covered with the cap 20, and in this state, the adhesive 30 is applied to the surface (first surface) 11 having the convex tooth row 12 (FIG. 10). The band is pressed from the 20 side so that the adhesive 30 is pressed against the surface of the splint (maxillary splint 50A, mandibular splint 50B), and the gap between the periphery of the cap 20 and the splint (maxillary splint 50A, mandibular splint 50B) is sealed. As shown in FIG. 6, the adhesive 30 is applied to the periphery of the cap 20 and its periphery (FIG. 6). In addition, what is necessary is just to perform application | coating of the adhesive agent 30 with the brush 31, etc., as FIG. 10 shows.

  Thus, in the connector 100 of the first embodiment, the convex teeth 12 formed on the bonding surfaces of the end portions 1A and 1B of the flexible band 1 increase the bonding strength to prevent the bonding portion from being displaced, and the like. The adhesive strength is further increased by 20 and the bonded portion is protected. Therefore, the movable mandibular frontal oral cavity device 50 (FIG. 6) obtained by connecting the maxillary splint 50A and the mandibular splint 50B with the connector 100 is attached to the maxillary and mandibular dentition in the oral cavity. Even if the upper jaw (upper jaw splint 50B) and the lower jaw (lower jaw splint 50B) of FIG. 8 are opened from the closed state of the upper jaw (upper jaw splint 50A) and the lower jaw (lower jaw splint 50B) of FIG. The end portions 1A and 1B of the flexible band 1 are maintained in a stable connection state without being detached from the splints (upper jaw splint 50A and lower jaw splint 50B). The shape of the cap 20 is not particularly limited as long as the cap 20 can appropriately cover the ends 1A and 1B of the flexible band 1. However, the shape of the cap 20 is increased, and the end of the flexible band is increased. From the viewpoint of protection, handleability, etc., as shown in FIGS. 3 and 5, a claw-like member having a recess 21 that fits into the end portions 1 </ b> A and 1 </ b> B of the flexible band 1 is preferable.

The material of the flexible band 1 can be used without limitation as long as the band is a material that does not substantially harm in the oral cavity and the band has flexibility. From the viewpoint of smooth movement of the lower jaw and difficulty in reducing the strength of the bonded portion due to movement of the upper and lower jaws, a relatively flexible resin band such as polyethylene, polypropylene, polyester, nylon, etc. is preferable. A polyethylene band is more preferable. The polyethylene may be any of low-density polyethylene, medium-density polyethylene, and high-density polyethylene, but from the viewpoint of the strength of the adhesive portion (the joint portion between the upper jaw splint 50A and the lower jaw splint 50B), a harder polyethylene is preferable and has a high density. Polyethylene is particularly preferred. In addition, "low density polyethylene" here refers to the polyethylene whose density (kg / m < ³ >) measured by the test method of JISK6922-1 is 918-940, and "high density polyethylene" The density (g / cm < ³ >) measured by the test method of ASTM D1505 points out the polyethylene of 0.947-0.968. Specific examples of low density polyethylene include Tosoh Corporation's Petrocene (trade name) series, and specific examples of high density polyethylene include Prime Polymer Co., Ltd.'s Hi-Zex (trade name) series. Can be mentioned. High density polyethylene having a density (g / cm ³ ) in the range of 0.947 to 0.964 is particularly preferable.

  The width of the flexible band 1 (A in FIG. 1) is preferably about 3 to 6 mm, and particularly preferably about 4 to 5 mm. The length of the flexible band 1 (B in FIG. 1) varies depending on the size of the patient's jaw (sprint), and is not particularly limited, but is generally selected from a range of 25 to 50 mm. is there. From the viewpoint of versatility, for example, a plurality of types of bands having specific sizes such as S size (25 mm), M size (30 mm), and L size (35 mm) may be used. The thickness of the flexible band 1 (C in FIG. 2) is preferably about 0.5 to 3.0 mm, more preferably about 1.0 to 2.0 mm from the viewpoint that the band deforms moderately while having a waist. Preferably, the thickness is about 1.0 to 1.5 mm, more preferably about 1.3 to 1.5 mm.

  The height of the convex teeth 12a of the convex tooth row 12 provided on the surface (first surface) 11 to which the flexible band 1 is bonded, that is, the depth of the groove 12b between the adjacent convex teeth 12a (in FIG. 2) D) is not particularly limited, but is about 1.0 to 1.5 mm so that the adhesive is sufficiently embedded in the groove 12b and the band below the groove 12b is not too thin. preferable. Further, the pitch of the convex teeth 12a (E in FIG. 2) is preferably about 1.2 to 2.0 mm, and the opening width (F in FIG. 2) of the grooves 12b between the adjacent convex teeth 12a is 0. About 5 to 0.8 mm is preferable. As shown in FIG. 2, the convex teeth 12a are preferably tapered with side surfaces inclined in view of embedding of the adhesive into the grooves 12b. However, even if the side surfaces are vertically cut. Good. In addition, as shown in FIG. 9, when forming the convex tooth row | line | column 12 only in edge part 1A, 1B used as the adhesion part of the flexible band 1, the length of edge part 1A, 1B which formed this convex tooth row | line | column 12 is shown. The length (G in FIG. 9) is preferably about 4 to 10 mm. That is, in the present invention, it is preferable that the lengths (length in the axial direction) of the end portions 1A and 1B serving as the bonding portions of the flexible band 1 be about 4 to 10 mm.

  The adhesive 30 is not particularly limited as long as the adhesive 30 is substantially harmless and does not easily reduce the adhesive force even in the oral cavity, but is an acrylic type that is widely used for dentistry because it is easy to handle and is easily available. And an epoxy room temperature polymerization resin are preferable, and an acrylic room temperature polymerization resin is particularly preferable. Preferable specific examples of the acrylic room temperature polymerization resin include UniFirst II Clear (trade name) manufactured by GC Corporation.

  The material of the cap 20 is not particularly limited, and a molded product of general-purpose resin can be used. From the viewpoint of adhesiveness with the adhesive 30 and the like, an acrylic resin is preferable, and preferable specific examples include, for example, Kuraray Co., Ltd. Manufactured by Comoglass, etc.

  Prior to adhering the end portions 1A and 1B of the flexible band 1 to the splint (maxillary splint, mandibular splint), it is preferable to roughen the adherend areas on the surfaces of the maxillary and mandibular splints with a file or the like. In addition, it is preferable to apply a primer application treatment (primer treatment). By performing such roughening treatment and primer treatment, the end portions 1A and 1B of the flexible band 1 are firmly bonded and bonded to the upper jaw and lower jaw splints 50A and 50B, thereby making the structure more stable. A movable mandibular frontal oral appliance can be achieved. The primer is not particularly limited, and an appropriate primer may be selected according to the material of the sprint. For example, dichloromethane is preferable when the upper jaw splint 50A is a polycarbonate mold, and ethyl acetate is preferable when the lower jaw splint is an acrylic resin mold.

  As is apparent from the connector 100 of the first embodiment, according to the connector for a mandibular front-oral-type intraoral device of the present invention, the end portions 1A and 1B of the flexible band 1 which is the connector body are splinted (upper jaw splint). The maxillary splint and the mandibular splint can be movably connected by simply adhering to the side surface of the mandibular splint. Therefore, the operation is simple and requires less time, and can be attached to the patient on the spot. In other words, in the case of the conventional movable mandibular frontal oral appliance, after determining the positional relationship between the maxillary splint and the mandibular splint in the clinic, the maxillary splint and mandibular splint are returned to the laboratory and the movable device is attached. However, with the connector of the present invention, the end portions 1A and 1B of the flexible band 1 that is the connector body are simply adhered to the side surface of the splint. Installation can be completed in a waiting state. In particular, by using a polyethylene band for the flexible band that is the connector body, the flexible band is easily deformed and the sprint can be moved smoothly. Furthermore, since the flexibility varies depending on the type of polyethylene, it is possible to select the degree of movement according to the case.

Hereinafter, modifications of the present invention will be described.
FIG. 11 shows an end portion of a flexible band in a connector for a mandibular frontal-type intraoral device according to a second embodiment of the present invention. FIG. 11 (a) is a schematic diagram of the first plane, and FIG. A schematic view of the plane, FIG. (C) is a schematic view of the side. In other words, the connector for the lower jaw front-orientation type intraoral device according to the second embodiment is a splint (upper jaw splint) of both axial end portions 1A and 1B, which is an adhesive portion to the splint (upper jaw splint, lower jaw splint) of the flexible band 1. The first convex tooth row in which a plurality of convex teeth 12a whose axis L2 is orthogonal to the axis L1 of the flexible band 1 are arranged in parallel on the first surface 11 which is the surface to be bonded to the lower jaw sprint). 12 is formed on the second surface 13 opposite to the first surface, and a plurality of convex teeth 14a whose axis L3 is parallel to the axis L1 of the flexible band 1 are arranged side by side. A convex tooth row 14 (that is, a second convex tooth row 14 intersecting with the first convex tooth row 12) is formed, and the bottom of the concave groove 12b between adjacent convex teeth of the first convex tooth row 12 and the first The bottom of the concave groove 14b between adjacent convex teeth of the second convex tooth row 14 is communicated. Than is. FIG. 12 is a schematic plan view of the second surface 13 of the flexible band 1. In the hatched region indicated by reference numeral 15, the groove 12b and the bottom of the groove 14b communicate with each other, which can be seen in the groove 14b. The hole formed by this is shown.

  In the case of the connector for the mandibular frontal type intraoral device of the second embodiment, a cap that covers the end of the flexible band 1 used in the connector for the mandibular frontal type intraoral device of the first embodiment. 20 can be made unnecessary. That is, the end portions 1A and 1B of the flexible band 1 are coated with an adhesive on the surface (first surface 11) on the bonding side to the splint (maxillary splint and mandibular splint) and splint (maxillary splint and mandibular splint). ) Through the hole 15, the adhesive leaks into the concave groove 14b on the second surface 13 side of the flexible band 1, and the leaked adhesive solidifies to obtain a strong adhesive force. Therefore, it is possible to achieve a movable mandibular frontal-oral-type intraoral device that is stable as a structure without using a cap as in the connector for the mandibular front-oral-oral device in the first embodiment. Therefore, in the movable mandibular frontal-type intraoral device obtained by using the connector for the mandibular frontal-type intraoral device according to the second embodiment, the flexible band 1 can be applied to the sprint (maxillary splint, mandibular splint). Since there is no part covered like a cap in the bonding part (bonding part), it is possible to further reduce discomfort during wearing.

In addition, in the connector for the mandibular front-orientation type intraoral device according to the second embodiment, the material of the flexible band 1, the dimensions of each part of the first convex tooth row 12, the type of adhesive, and the pretreatment before bonding ( The sprint surface roughening treatment, primer treatment, etc., are followed as they are in the connector for an oral device of the lower jaw in the first embodiment. In addition, the size of each part of the second convex tooth row 14 may be the same as that of the first convex tooth row 12. However, the thickness of the flexible band 1 is preferably about 1.5 to 3.5 mm, more preferably about 2 to 2.5 mm. The size (opening area) of the hole 15 is preferably about 0.25 to 0.64 mm ² .

  FIG. 13 is a schematic perspective view of the vicinity of the end of the flexible band in the connector for the lower jaw front-facing intraoral device of the third embodiment of the present invention. That is, the connector for the lower jaw front-orientation type intraoral device of the third embodiment has a plurality of through-holes 17 at both axial end portions 1A and 1B to the sprint of the flexible band 1 (upper jaw sprint, lower jaw sprint). The thin piece member 16 is fixed, and the thin piece member 16 is bonded to a splint (upper jaw splint, lower jaw splint) with an adhesive.

  In the case of the connector for the mandibular front-orientation type intraoral device according to the third embodiment, one of the flat plate portions 16a for bonding of the thin piece member 16 having a plurality of through holes 17 fixed to the end portions 1A and 1B of the flexible band 1 is provided. When the adhesive is applied to the surface 16A and the thin piece member 16 is pressed against the splint (upper jaw splint, lower jaw splint), the adhesive overflows through the through hole 17 to the other surface 16B of the flat plate portion 16a for bonding, The other surface 16B is solidified in a state where it is covered with an adhesive, and the thin piece member 16 (adhesion flat plate portion 16a) is firmly bonded to the splint (upper jaw splint, lower jaw splint). Therefore, the movable mandibular frontal cavity type intraoral device which is stable as a structure can be achieved without using a cap like the connector for the mandibular frontal cavity type intraoral device of the first embodiment. Accordingly, the movable mandibular frontal-oral-type intraoral device obtained by using the connector for mandibular front-oral-oral device in the third embodiment is the same as the connector for the mandibular front-oral-oral device in the second embodiment. Furthermore, since there is no portion covered like a cap in the adhesive portion (bonding portion) to the sprint (upper jaw sprint, lower jaw sprint) of the flexible band 1, discomfort at the time of wearing can be further reduced.

  As the material of the flake member 16, a biocompatible resin, metal, ceramic material or the like can be used. Specifically, a molded body such as polysulfone resin, fluororesin or silicone resin, metal such as titanium, stainless steel or platinum. A thin plate can be mentioned, and among these, a titanium thin plate is preferable. The thin piece member 16 in FIG. 13 is a titanium thin plate provided with a gripping portion 16 b, and the gripping portion 16 b is caulked and crimped to the end portions 1 A and 1 B of the flexible band 1.

The thickness of the bonding flat plate portion 16a of the thin piece member 16 is preferably about 0.5 to 1.5 mm, particularly preferably about 0.5 to 0.7 mm. The length in the same direction as the axial direction of the flexible band 1 of the flat plate portion 16a for bonding (H in FIG. 13) is preferably about 4.0 to 10.0 mm. Moreover, the hole shape of the through-hole 17 may be a square hole such as a square or a rectangle in addition to the circular hole shown in the figure. The size (opening area) of the through hole 17 is preferably about 0.79 to 1.78 mm ² (in the case of a circular hole, the hole diameter (diameter) is preferably 1.0 to 1.5 mm).

  In the connector for the lower jaw front-orientation type intraoral device according to the third embodiment, the material and dimensions of the flexible band 1, the type of adhesive, the pretreatment before bonding (sprint roughening treatment, primer treatment), etc. Is the same as that of the connector for the lower jaw front-orientation type intraoral device of the first embodiment. However, the length of the flexible band 1 (the length in the axial direction) is preferably shortened by the length of the thin piece member 16.

As can be seen from the above description, in the connector for a mandibular front-oral-type intraoral device of the present invention, the upper jaw and the lower jaw splint can be connected by simply bonding the end of the flexible band as the connector body to the side surface of the splint. Since the movable mandibular frontal type intraoral device can be completed, it is easy to operate and requires less time, and the movable mandibular frontal type intraoral device can be mounted on the patient on the spot.
In addition, the structure is simple, there are few parts, the cost is low, and the cost of the mounting operation is low.
Further, in the conventional movable mandibular frontal cavity type intraoral device, the connecting means for the maxillary splint and the mandibular splint is incorporated and attached to the splint at the time of the production of the splint, whereas the connector for the mandibular frontal cavity type intraoral device of the present invention Since it is bonded to the prepared maxillary splint and mandibular splint later with an adhesive, it is easy to change and repair the mandibular position in a mobile mandibular frontal type oral appliance, and it can be fixed in use. It is also possible to change to a movable mandibular frontal-type intraoral device by attaching the connector for mandibular frontal-type intraoral device of the present invention later to the mandibular frontal type intraoral device.

Hereinafter, the present invention will be described more specifically with reference to examples and comparative examples.
A tensile test was performed with the connector of the present invention in clinical condition, the fracture site was confirmed, and the fracture load was measured. As a comparison object, a conventionally known movable mandibular frontal oral appliance ("Silencer" manufactured by Elcodent Co., Ltd.) whose connection form to the maxillary and mandibular splints is similar to the connection form to the maxillary and mandibular splints by the connector of the present invention. A similar test was performed.
The details of the test are as follows.

[Test 1]
1. Material to be used (A) To-be-linked body: Flat plate made of polycarbonate (PC) (manufactured by Joydental, “Imperon S”). Thickness: 2.0mm, width: 15mm, length: 50mm
(B) Flexible band Band 1: Thickness: 1.3 mm, Width: 4.0 mm, Length 35 mm Soft belt (Tosoh Corp., “Petrocene”, low density polyethylene)
Band 2: Thickness: 1.3 mm, width: 4.0 mm, length 35 mm hard belt (manufactured by Prime Polymer, “Hicks 5100E”, high density polyethylene),
(C) Adhesive Acrylic-based room temperature polymerization resin ("C" Co., Ltd. "Unifirst II Clear")
PC Adhesive (Sankin Co., Ltd. Adhesive Treatment Agent (Primer) for Polycarbonate)
(D) Cap Acrylic resin cap (Kuraray, Como Glass)
(E) Conventionally known movable mandibular frontal-type intraoral device (silencer)
Sprint part: Ercodeur (trade name) (manufactured by Elcodent, material: cellulose acetobutyrate)
Connector part: Silencer (trade name) (manufactured by Elcodent, material: polyoxymethylene copolymer) i) The silencer consists of three parts: "connector", "stopper" and "shell".

2. Test Method The objects to be connected were regarded as sprints, and two of them were connected with the connector of the present invention to prepare a sample for a tensile test.
The sample was made into two conditions using band 1 (soft belt) and band 2 (hard belt).

That is,
Example 1 (Sample 1): Both ends (length: 35 mm) of the band 1 are bonded to a connected body (Imperon S) using an adhesive and a cap.
Example 2 (Sample 2): Both end portions (length: 35 mm) of the belt 2 are bonded to a connected body (Imperon S) using an adhesive and a cap.
Two types of samples were prepared.

  Similarly, as Comparative Example 1 (Sample 3), an ercodeule flat plate (a strip sample having a thickness of 1.5 mm, a width of 15 mm, and a length of 50 mm) is regarded as a sprint, and two of them are used by the ercodeur. It connected with the connection method.

14 is a schematic cross-sectional view of the main part (connecting part) of Samples 1 and 2, and FIG. 15 is a schematic cross-sectional view of the main part (connecting part) of Sample 3.
The connection part of the samples 1 and 2 has a structure in which the end of the band 62 is fixed to the connected body 61 with the adhesive 63 and the cap 64 (FIG. 14).
On the other hand, the connecting portion of the sample 3 is a structure adopted by Ercodeur (manufactured by Elcodent), and a through-hole 72 is formed at a predetermined portion of a connected body (Elcodeur) 71 made of CA (cellulose acetobutyrate). A through hole 74 is formed at the end of the connector 73, the two are aligned so that the axes of the through hole 72 and the through hole 74 coincide with each other, and the shell 75 and the stopper 76 are inserted into the through hole from both sides of the through hole. Thus, the coupled body 71 and the connector 73 are coupled (FIG. 15).

  The tensile test was performed under two conditions: a condition of pulling in the axial direction of the band or silencer (connector) (first condition) and a condition of pulling in the direction perpendicular to the axis (second condition). 14 and 15, an arrow A indicates an axial pulling direction, and an arrow B indicates a direction perpendicular to the axis.

  Seven samples 1 to 3 were prepared and tested seven times. The tensile test was performed using a universal testing machine AGS10KNG (SHIMAZU), measuring the breaking load and observing the breaking site at a crosshead speed of 25 mm / min.

  Table 1 shows the breaking load and the breaking site of each sample.

  The largest tensile strength in the axial direction was 126.7 ± 12.2 N of the silencer (sample 3). Next, the connection body of the connector of the present invention using a hard belt (sample 2) was 84.2 ± 0.6 N, and the smallest value was the connection body of the connector of the present invention using a soft belt (sample 1). Of 55.4 ± 0.7 N.

  The largest tensile strength in the direction perpendicular to the shaft was 81.0 ± 3.9 N of the connection body (sample 2) by the connector of the present invention using a hard belt. Next, 55.8 ± 1.5N of the connection body (sample 1) by the connector of the present invention using a soft belt, and the lowest value was 35.9 ± 2.5N of the silencer (sample 3). .

  In the pulling in the axial direction, the belt portion was broken in both the sample 2 using the hard belt, the sample 1 using the soft belt, and the silencer (sample 3).

  When pulling in the direction perpendicular to the axis, in sample 2 using the hard belt, the connection cap is broken in all seven samples, and in sample 1 using the soft belt, the belt is broken in all seven samples. did. In the connection using the silencer, the stopper of the connection part was damaged in all seven samples.

  With the connector of the present invention, the connector in the axial direction of the mandibular frontal oral appliance in which the maxillary splint and the mandibular splint are connected by the connector of the present invention and the conventional movable mandibular frontal oral appliance such as a “silencer”, It corresponds to the load during the backward movement, and the pull in the direction perpendicular to the axis is considered to correspond to the load during the lateral movement of the lower jaw.

  In the axial pull test of the connector, both the sample 1 using the soft belt, the sample 2 using the hard belt, and the silencer (sample 3) were broken at the connecting shaft part of the device. The breaking strength (load) was in the order of sample 2 using a silencer, a hard belt, and sample 1 using a soft belt.

  The tensile test in the direction perpendicular to the connector axis, which corresponds to the lateral movement of the lower jaw, is a more severe test for the connection part of the connector splint, and the strength depends on the relative strength of the connection part and the connector shaft part. The lower part of was destroyed. In sample 2 using a hard belt, the cap of the connecting portion was broken, and in sample 1 using a soft belt, the belt was broken. In addition, in the silencer (Sample 3), the destruction concentrated on the stopper of the connecting portion.

  In clinical practice, the strength of the lowest strength portion is regarded as the strength of the device. Therefore, in the mandibular frontal oral device using the connector of the present invention, it is perpendicular to the belt axis in the sample 2 using the soft belt. The strength (55.8 N) when pulled in the direction can be said to be the strength of the device. From the same viewpoint, it can be said that the strength of the silencer (sample 3) is 35.9N. From this result, the mandibular frontal type oral appliance in which the maxillary splint and the mandibular splint are connected by the connector of the present invention has about 1.5 times the strength of the conventional movable mandibular frontal type oral appliance (silencer). It is thought that it can be used safely in clinical practice because of its strength.

[Test 2]
Sample 4 (Example 3) using a soft belt and a hard belt were used in the same manner as in Test 1 except that AR (acrylic resin) was used as the connected body and ethyl acetate was used as the adhesive treatment agent. Sample 5 (Example 4) was prepared, the same tensile test was performed, and the breaking load was measured and the breaking portion was observed. The results are shown in Table 2 below.

  As can be seen from Table 2, in Test 2, the same result as in Test 1 was obtained, and regardless of the material of the splint, the front jaw type oral cavity obtained by connecting the maxillary splint and the mandibular splint by the connector of the present invention. The device can be used safely in clinical practice.

[Clinical evaluation]
Out of 76 patients (56 men, 20 women) diagnosed with sleep apnea syndrome, mandibular anterior orientation type by examination and X-ray examination (panoramic X-ray photograph and head side X-ray standard photograph) It was judged that the intraoral device was effective, and there were 55 patients who made and installed the device. Of the 55 persons, the connector of the first embodiment of the present invention (flexible band: hard belt (manufactured by Prime Polymer Co., “Hicks 5100E”, high-density polyethylene belt), adhesive: acrylic room temperature polymerization A mandibular frontal oral cavity device made by connecting the upper and lower jaw splints with a resin (GC Corporation, “UniFirst II Clear”), cap: acrylic resin cap (Kuraray Co., Ltd., Comoglas)) was used. There were 22 cases, and among the 22 cases, 9 cases were changed from the conventional upper / lower jaw fixed type device to the mandibular frontal type oral appliance using the connector of the present invention.
All 22 cases showed improvement in subjective symptoms such as reduced snoring and reduced daytime sleepiness. In addition, there were 10 cases that could be evaluated by overnight polysomnography after wearing, and the improvement rate of Apnea hypoapnea index (AHI) was 50% or more in all cases. It was effective.
In addition, in the case of changing from the mandibular frontal oral appliance using the conventional maxillary and maxillary splint fixation method (resin fixation) to the mandibular frontal oral appliance using the connector of the present invention, the sense of tension in the masseter muscle part when waking up The effects on the temporomandibular joint and masticatory muscles were reduced.
This application is based on Japanese Patent Application No. 2006-229930 filed in Japan, the contents of which are incorporated in full herein.

Claims (11)

A connector for connecting an upper jaw and a lower jaw splint made of a resin or elastomer mold to a state in which the upper jaw and the lower jaw can be opened and closed while keeping the lower jaw in a forward orientation,
Either one of the axial ends is the adhesive part to the maxillary splint, and the other is the adhesive part to the mandibular splint. A flexible band forming a dentition);
A cap that covers each end of the flexible band;
Adhering the upper end of the flexible band together with the cap covering the end portion of the flexible band with an adhesive, and the molar portion of the lower splint together with the cap covering the other end portion of the flexible band A connector for a mandibular frontal oral cavity device that improves sleep apnea syndrome or snoring, and is configured to adhere to the vicinity by an adhesive.   The connector for a mandibular frontal-orientation type oral cavity device for improving sleep apnea syndrome or snoring according to claim 1, wherein the cap is formed of a claw-like member having a recess fitted to an end of a flexible band.   The connector for a mandibular frontal oral cavity device for improving sleep apnea syndrome or snoring according to claim 1 or 2, wherein the flexible band is a polyethylene band.   The upper jaw splint is a polycarbonate mold, the lower jaw splint is an acrylic resin mold, the flexible band is a polyethylene band, the cap is an acrylic resin cap, and the adhesive is a dental room temperature polymerization resin. The connector for an oral device of the mandibular orientation type that improves sleep apnea syndrome or snoring according to claim 1 or 2. A connector for connecting an upper jaw and a lower jaw splint made of a resin or elastomer mold to a state in which the upper jaw and the lower jaw can be opened and closed while keeping the lower jaw in a forward orientation,
Either one of the axial end portions is an adhesive portion to the maxillary splint, and the other is an adhesive portion to the mandibular splint, and the first surface that is the side that adheres to the maxilla or the mandibular splint at both ends A first convex tooth row is formed on the second surface opposite to the first surface, and a second convex tooth row intersecting the first convex tooth row is formed on the second surface. A flexible band formed by communicating the bottom of the concave groove between adjacent convex teeth of the dentition and the bottom of the concave groove between adjacent convex teeth of the second convex dentition;
By adhering one end of the flexible band near the canine part of the maxillary splint with an adhesive, and adhering the other end to the vicinity of the molar part of the mandibular splint using an adhesive, The adhesive is embedded in the concave groove between adjacent convex teeth of the first convex tooth row and the concave groove between adjacent convex teeth of the second convex tooth row at the end of the flexible band. A connector for a mandibular frontal oral appliance that improves sleep apnea syndrome or snoring.   The connector for a mandibular frontal oral cavity device for improving sleep apnea syndrome or snoring according to claim 5, wherein the flexible band is a polyethylene band.   The sleep apnea according to claim 5, wherein the upper jaw splint is a polycarbonate mold, the lower jaw splint is an acrylic resin mold, the flexible band is a polyethylene band, and the adhesive is a dental room temperature polymerization resin. Mandibular frontal oral cavity connector for the improvement of syndrome or snoring. A connector for connecting an upper jaw and a lower jaw splint made of a resin or elastomer mold to a state in which the upper jaw and the lower jaw can be opened and closed while keeping the lower jaw in a forward orientation,
A thin piece member having a plurality of through holes is fixed to each of the both ends of the flexible band in which either one of both ends in the axial direction is used for bonding to the upper jaw sprint and the other is used for bonding to the lower jaw sprint. ,
The thin piece member fixed to one end portion of the flexible band is adhered to the vicinity of the canine portion of the maxillary splint by an adhesive, and the thin piece member fixed to the other end portion is adhered to the vicinity of the molar tooth portion of the mandibular splint. A connector for a mandibular frontal-orientation type oral cavity device for improving sleep apnea syndrome or snoring, wherein the adhesive is embedded in a plurality of through-holes of a thin piece member by bonding with the adhesive.   The connector for a mandibular frontal oral cavity device for improving sleep apnea syndrome or snoring according to claim 8, wherein the flexible band is a polyethylene band.   The upper jaw splint is a polycarbonate mold, the lower jaw splint is an acrylic resin mold, the flexible band is a polyethylene band, the adhesive is a dental room temperature polymerization resin, and the flake member is made of titanium. Item 9. A connector for a mandibular frontal oral cavity device for improving sleep apnea syndrome or snoring according to Item 8.   The connector for a mandibular frontal-orientation type oral cavity device for improving sleep apnea syndrome or snoring according to any one of claims 1 to 10, wherein the adherend areas of the maxillary splint and the mandibular splint are preliminarily treated with a primer.

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