WO2008023799A1

WO2008023799A1 - Mandibular anterior connector to be placed in the oral cavity for relieving sleep apnea syndrome or snoring

Info

Publication number: WO2008023799A1
Application number: PCT/JP2007/066468
Authority: WO
Inventors: Kiyoshi Nagano; Naomi Tanoue; Soichi Yanamoto
Original assignee: Nagasaki University
Priority date: 2006-08-25
Filing date: 2007-08-24
Publication date: 2008-02-28
Also published as: JPWO2008023799A1; JP4998958B2

Abstract

It is intended to provide a mandibular anterior connector to be placed in the oral cavity for relieving sleep apnea syndrome or snoring which has a simple structure, is less expensive, can be easily attached to splint within a short period of time and easily allows the alteration of the mandibular position or repair after the attachment. Namely, a mandibular anterior connector having a flexible band (1), in which one of the both ends (1A, 1B) thereof in the axial direction serves as a bonding part to a maxillary splint (50A) while the other end serves as a bonding part to a mandibular splint (50B) and multiple convex teeth (convex tooth arches) (12) are formed in the faces of the ends (1A, 1B) to be bonded to the maxillary or mandibular splint, and caps (20) to be put respectively on the both ends (1A, 1B) of the flexible band (1), wherein one end (1A) of the flexible band (1) is bonded together with the cap (20) putting thereon to the maxillary splint (50A) at the position close to the canine tooth with the use of an adhesive (30) and the other end (1B) thereof is bonded together with the cap (20) putting thereon to the mandibular splint (50B) at the position close to the molar tooth with the use of an adhesive.

Description

Specification

Connector for mandibular frontal oral appliance that improves sleep apnea syndrome or snoring

Technical field

TECHNICAL FIELD [0001] The present invention relates to a connector for a mandibular frontal oral appliance that improves sleep apnea syndrome or snoring, and in particular, has a simple configuration and does not require a joint to be embedded in a splint and the like. The present invention relates to a connector for a mandibular frontal oral cavity device with improved sleep apnea syndrome or snoring that can be attached to a splint.

Background art

[0002] Sleep apnea syndrome is an illness in which breathing stops during sleep (apnea) intermittently, and was proposed in the United States in 1976. Respiratory power ¾ 0 or more or sleep apnea / hypopnea (apnea / hypopnea index: AHI) of 5 or more, some of which are the norm for healthy people The definition of “when we can observe regular breathing during sleep called non-REM sleep” is often used. When a person develops strength or illness, he / she can not sleep enough, and he / she loses daytime, concentration, lack of vitality, and tends to fall asleep. In the United States, patients with this disease are involved in the context of the nuclear accident on Three Mile Island, a tanker landing off Alaska, an explosion just after the launch of the Space Shuttle Challenger, or a large trailer accident on the highway. Has been reported. It has also been reported in Japan that it was related to an illness that caused the sleepy driving of Sanyo Shinkansen drivers. Therefore, since there is a concern that accidents that could endanger human life if left untreated without sleeping apnea syndrome, appropriate measures such as symptom analysis and diagnosis, treatment, and prevention are required. .

[0003] Sleep apnea syndrome includes “central type (CSAS)” in which orders from the respiratory center stop, “obstructed type (OSAS)” due to upper airway stenosis or obstruction, and a mixture of central type and obstructive type “ Although it is classified as “mixed type”, the occlusion type in which the airway is physically blocked by the tongue and apnea is the target of treatment by the dentist. [0004] 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 airway, the pressure in the airway becomes lower during inspiration, resulting in a narrower airway. Breathing occurs. Snoring is caused by the flow of air through a narrow airway, and not always snoring due to large snoring, but the airway is strong and narrow, and is obstructive (OSAS ) Is likely to occur.

[0005] Sleep splint is a common name for mandibular frontal oral appliance (PMA) and is used to prevent snoring and to treat mild obstructive sleep apnea syndrome (OSAS). The majority of sleep disordered breathing associated with V, snoring, or upper airway obstruction is caused by the relaxation of the tongue muscle, especially the genioglossus muscle, and the tongue dropping backwards during sleep. It is thought to be caused by constriction or obstruction of the airway. Sleep printing improves upper airway obstruction and snoring by positioning the lower jaw and tongue forward while sleeping and dilating the upper airway. As for this detailed mechanism, it has been clarified! /, NA! /, Many parts, but by positioning the mandible forward relative to the maxilla, the genioglossus muscle attached to the inner surface of the mandible develops As a result, the tongue is also pulled forward, and the upper airway is thought to expand.

[0006] The sleep splint consists of parts to be attached to the upper jaw (maxillary splint) and a part to be attached to the lower jaw (mandibular splint), and the upper and lower parts are connected at a position where the airway during sleep is secured (ie, the frontal orientation of the lower jaw) And use it. There are two types of connection methods: one that attaches the upper and lower parts and the other that is movable and allows some movement such as opening and closing while keeping the lower jaw in the forward orientation. The fixed type requires no parts for connection and is easy to connect.However, the lower jaw is fixed during sleep, so the feeling of wearing is inferior and the burden on the temporomandibular joint is concerned. The For this reason, 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 United States, there is already an FDA (Food & Drug Administration) that is effective for snoring and obstructive sleep apnea syndrome (OSAS).

[0007] Many of these mobile sleep sprints have (1) push forward, (2) pull forward, or (3) pull with a hook with the upper jaw as a fulcrum to hold the lower jaw in the forward orientation. Hanging I have a way to (1) In the method of pushing forward, the maxillary molar portion and the mandibular anterior 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 resin materials are also used in addition to metals. (3) For hooks that are hooked, the hook and the receiving part are made of metal. Specifically, for example, in a device manufactured by Scheu-Dental (sales Co., Ltd., Morita), hooks fixed on the upper part (maxillary sprint) are hooked on the wire of the front teeth of the lower part (maxillary sprint). The “silencer” (trade name) manufactured by Elcodent (sales: Nippon Dental Supply Co., Ltd.) is used to prevent the lower jaw from retracting. Jonito is embedded in the molar part of the part (mandibular splint) in advance, and the connecting members are fastened to the joints of these upper and lower parts. Furthermore, in Patent Document 1 below, hooks are attached to the vicinity of the molar teeth of the canine part of the maxillary splint and the splint of the mandible, and elastic bands such as rubber bands are removably hooked on these hooks and fixed. Something to do is also proposed. The range of motion of the lower jaw of these movable sleep splints is generated by the hinge movement of the joint between the splint and the connecting member, the elasticity of the sheath-like device, or the play of the hook and the receiver.

However, all of the conventionally known movable sleep splints (that is, the mandibular front-orientation type intraoral device) as described above are joints for connecting a connecting member to upper and lower parts (maxillary splint and mandibular splint) in advance. Hooks must be embedded and fixed (that is, the joints must be created), and the production of the joints is complicated and complicated. There is a problem that it takes effort S. In addition, the number of parts required for the whole connecting means including the joint portion is small, and the price of each part is not low, and there is a problem that the cost is increased. There is also a problem that changing or repairing the lower jaw position is not easy. Furthermore, since the sprint is designed to include the connecting means, the connecting means cannot be applied to the already-used fixed sprint (ie, the connecting means is attached later to the existing sprint). Cannot be done).

Patent Document 1: JP 2004-73473 A Disclosure of the invention

Problems to be solved by the invention

[0009] In view of the above circumstances, the problem of the present invention is that the configuration is simple and inexpensive, and can be easily and quickly mounted on a splint, and the mandibular position can be easily changed and repaired after mounting. It is an object of the present invention to provide a connector for a mandibular frontal oral appliance that improves sleep apnea syndrome or snoring, which can realize a movable mandibular frontal oral appliance.

Means for solving the problem

In order to solve the above problems, the present invention has the following features.

(1) A connector for connecting the upper and lower jaw splints made of resin or elastomer mold to a state where the upper and lower jaws can be opened and closed while keeping the lower jaw in the forward orientation.

Either one of the axial ends is bonded to the maxillary splint, and the other is bonded to the maxillary sprint, and the force is bonded to the maxilla or mandible sprint at both ends. A flexible band forming a (convex tooth row);

A cap that covers each end of the flexible band;

Adhesive adhesive in the vicinity of the canine part of the maxillary splint together with a cap that covers one end of the flexible band, and the lower teeth of the mandibular splint together with the cap that covers the other end A connector for intraoral device with mandibular frontal orientation for sleep apnea syndrome or! /, With improved snoring.

(2) The connector for a mandibular frontal 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 that fits into an end of a flexible band. .

(3) The connector for a mandibular frontal oral cavity device for improving sleep apnea syndrome or! /, Snoring disease described in 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. The connector for a mandibular frontal oral cavity device with improved sleep apnea syndrome or snoring as described in (1) or (2) above, which is a resin. (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 to be attached to the maxilla or the mandibular splint at both ends. Forming a first convex tooth row on the surface, and forming a second convex tooth row intersecting the first convex tooth row on the second surface opposite to the first surface; A flexible band is formed by connecting the bottom of the concave groove between adjacent convex teeth of the convex tooth row and the bottom of the concave groove between adjacent convex teeth of the second convex tooth row,

Adhering one end of the flexible band near the canine of the maxillary splint with an adhesive and adhering the other end near the molar tooth of the mandibular splint using an adhesive The adhesive is embedded in the concave groove between the adjacent convex teeth of the first convex tooth row and the concave groove between the adjacent convex teeth of the second convex tooth row at the end of the flexible band. Connector for anterior device of the mandibular orientation that improves sleep apnea syndrome or snoring

(6) The connector for a sleep apnea symptom group or snoring-improved mandibular oral cavity device according to (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, Connector for oral appliance of the mandibular orientation that improves sleep apnea syndrome or snoring.

(8) A connector for connecting a maxillary and mandibular splint made of a resin or elastomer mold so that the maxillary and mandibular can be opened and closed while keeping the mandibular in a forward orientation,

A thin piece member having a plurality of through holes is fixed to 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. ,

A thin piece member fixed to one end of the flexible band is attached to the canine portion of the maxillary splint Adhering the thin piece member near the molar teeth of the lower jaw splint with an adhesive, and then applying the force and adhesive with the adhesive, the adhesive is removed from the thin piece member. A connector for an oral appliance of the mandibular orientation type that improves sleep apnea or!

(9) The connector for a sleep apnea symptom group or snoring-improved mandibular oral cavity device according to (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 thermopolymer resin, and the flake member is titanium. The connector for sleep apnea symptoms group or snoring improvement mandibular frontal oral cavity device according to the above (8), which is manufactured.

(11) Improvement of sleep apnea syndrome or snoring according to any one of (1) to (; 10) above, wherein the adherend areas of the maxillary splint and mandibular splint are pre-primed! Mandibular orientation connector for intraoral device.

The invention's effect

According to the connector for the lower jaw front-orientation type intraoral device of the present invention, the movable mandibular front-orientation type by connecting the upper jaw and the lower jaw splint by simply bonding the end of the flexible band that is the connector body to the side surface of the splint. Since the intraoral device can be completed, a movable mandibular frontal device that is easy to operate and requires less time can be attached to the patient on the spot.

Also, by using a polyethylene band for the flexible band that is the connector body, the flexible band is 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 mobility according to the case.

In addition, the structure is simple, the cost of fewer parts is low, and the cost of installation is low.

In addition, the connector for a mandibular front-facing intraoral device according to the present invention is not intended to be installed in a sprint when the sprint (maxillary sprint, mandibular sprint) is manufactured. And then bond with adhesive Therefore, it is possible to easily change and repair the mandibular position in the movable mandibular frontal-type intraoral device.

Brief Description of Drawings

[0012] FIG. 1 is an exploded view of a connector for a mandibular frontal oral appliance according to a first embodiment of the present invention.

2 is a cross-sectional view of the main part of the flexible band shown in FIG.

FIG. 3 is a side view of the cap shown in FIG. 1.

4 is a plan view showing a state where a cap is put on the end of the flexible band shown in FIG. 1. FIG.

FIG. 5 is a perspective view showing a state where a cap is put on the end of the flexible band shown in FIG. 1.

FIG. 6 is a schematic perspective view of a movable mandibular front-oral-type intraoral device in which the maxillary splint and the mandibular splint are connected using the connector shown in FIG.

FIG. 7 is a schematic plan view of the state where the movable mandibular front-orientation-type intraoral device of FIG. 6 is mounted in the oral cavity, with the upper and lower jaws closed.

FIG. 8 is a schematic plan view of the state in which the movable mandibular front-orientation type intraoral device of FIG.

FIG. 9 is a plan view of a flexible band according to another embodiment.

FIG. 10 is a diagram in which an adhesive is applied to the end of the flexible band.

FIG. 11 is a diagram showing an end of a flexible band in a connector for a mandibular front-oral-type intraoral device according to a second embodiment of the present invention. FIG. (A) is a schematic diagram of the first plane, and FIG. ) Is a schematic diagram of the second plane, and FIG.

12 is an explanatory diagram of holes formed in the concave groove in the flexible band shown in FIG. 11.

FIG. 13 is a schematic perspective view of the vicinity of the end of a flexible band in a connector for a mandibular frontal-type intraoral device according to a third embodiment of the present invention.

FIG. 14 is a schematic cross-sectional view of the main part of Examples 1 and 2 (Samples 1 and 2).

FIG. 15 is a schematic cross-sectional view of the main part of Comparative Example 1 (Sample 3).

Explanation of symbols

[0013] 1 Flexible band

1A, IB end of flexible band 12 Convex teeth

20 cap

30 Adhesive

50A maxillary splint

50B Mandibular splint

100 connectors

BEST MODE FOR CARRYING OUT THE INVENTION

[0014] Hereinafter, the present invention will be described in detail.

FIG. 1 is an exploded view of a connector for a sleep splint (i.e., a mandibular forward type intraluminal device) according to a first embodiment of the present invention, and 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 FIGS. 4 and 5 are a plan view and a perspective view of a state where a 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 appliance that connects the maxillary splint and the mandibular splint using the connector shown in Fig. 1. Figs. 7 and 8 show such a mobile mandibular frontal oral cavity. FIG. 7 is a schematic plan view of the state in which the internal 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.

[0016] 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. The mandibular frontal oral device connected to allow some movement such as opening and closing while keeping the mandibular frontal direction, and the connector (connector 100) of the present invention is shown in FIGS. As shown in the figure, on the left and right sides of the maxillary splint 50A and the mandibular splint 50B, the end of the flexible band 1 that is the main body is connected to the outer surface of the maxillary and mandibular splints 50A and 50B. With the use of the connector of the present invention, the upper jaw and the lower jaw splint are connected in a state where the upper jaw and the lower jaw can be opened and closed while keeping the lower jaw in the forward orientation, so that the movable lower anterior oral cavity device Is realized.

[0017] The upper jaw splint and the lower jaw splint connected by the connector of the present invention are particularly limited. Rather, a splint made of a general resin or elastomer mold (molded body) manufactured according to a conventional general material and manufacturing method is applied. 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.

[0018] In the connector 100 of the first embodiment, the flexible band 1 and the two caps 20 (Fig. 1) that cover both ends of the flexible band 1 are 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 by connecting either one of its axial ends 1A, IB to the maxillary splint 50A and the other to the mandibular splint 50B. Is done. The end 1A, IB is bonded to the splint by bonding the end 1A, IB to the splint with an adhesive 30. In a conventional movable mandibular frontal oral appliance, joints and hooks for connecting connecting members are embedded in the sprint (maxillary sprint, mandibular sprint) itself (that is, a joint portion is formed in the sprint). The connecting member is attached to the joint or the hook, and the upper jaw splint and the lower jaw splint are connected! /, And the force that has caused the work time to be extended, etc. In the connector of the present invention, the connector of the first embodiment 1 00 As shown in Fig. 4, the end 1A and IB of the flexible band 1 that is the connector body are simply adhered to the surface of the splint (maxillary splint 50A, mandibular splint 50B), so operation is simple and requires less time. . As shown in Figs. 7 and 8, normally, one end 1A of the flexible band 1 is connected to the canine of the maxillary splint 50A on the right and left sides of the splint (maxillary splint 50A, mandibular splint 50B). Adhere to the vicinity of the part and the other end 1B to the vicinity of the molar part of the mandibular splint 50B.

[0019] As shown in FIG. 1, the axis (L2) of the flexible band 1 has an axis L2 on the surface (first surface) 11 to be bonded to the sprint of the flexible band 1 (upper jaw sprint, lower jaw sprint). A convex tooth row 12 (FIG. 2) in which a plurality of convex teeth 12a orthogonal to the axis L1 are arranged in parallel is 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. Convex teeth only on end 1A and IB to be bonded 12 may be formed. Adhesion of the flexible band 1 to the end 1A and IB of the sprint is performed as shown in FIGS. 4 and 5. Cover the surface (second surface) 13 opposite to the surface 11) with the cap 20, and in this state, apply the adhesive 30 to the surface (first surface) 11 with the convex row 12 (Fig. 10), The band is pressed from the cap 20 side, and 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 the periphery thereof (FIG. 6). Note that the adhesive 30 may be applied with, for example, a brush 31 as shown in FIG.

[0020] As described above, in the connector 100 of the first embodiment, the adhesive strength is increased by the convex tooth row 12 formed on the end surface 1A of the flexible band 1 and the adhesive surface of the IB to prevent the adhesive portion from being displaced. However, the cap 20 further increases the adhesive strength and protects the bonded portion. 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 (maxillary splint 50B) and the lower jaw (mandibular splint 50B) in FIG. 8 are opened, the upper jaw (maxillary splint 50B) and the lower jaw (mandibular splint 50B) are closed (closed state). The ends 1A and IB of the flexible band 1 are maintained in a stable connection state without being detached from the splints (upper jaw splint 50A, lower jaw splint 50B). Note that the shape of the cap 20 is not particularly limited as long as the cap 20 can appropriately cover the ends 1A and IB of the flexible band 1. However, the shape of the cap 20 is not limited, and the end of the flexible band is increased. From the viewpoint of protection of the part, handling property, etc., as shown in FIGS. 3 and 5, it is preferable that the claw-like member has a recess 21 that fits into the end 1A and IB of the flexible band 1.

[0021] The material of the flexible band 1 can be used without limitation as long as it is a material that allows the band to have flexibility when it is a band that does not substantially cause harm in the oral cavity. From the viewpoint of smooth movement of the upper and lower jaws and a decrease in the strength of the bonded part due to movement of the upper and lower jaws, it is made of a relatively flexible resin such as polyethylene, polypropylene, polyester, nylon, etc. Even though bands are preferred, polyethylene bands are more preferred. Polyethylene is low density polyethylene, medium density polyethylene, and high density polyethylene. Any of these may be used, but high-density polyethylene is particularly preferred, with a preference for stiffer polyethylene from the viewpoint of the strength of the adhesive part (joint with upper jaw splint 50A and lower jaw splint 50B). The term “low density polyethylene” as used herein refers to polyethylene having a density (kg / m ³ ) measured by the test method described in JIS K 6922-1 of 918 to 940, and “high density polyethylene” Refers to polyethylene having a density (g / cm ³ ) force of 0.947-0.968 as measured by the test method described in ASTM D1505. Specific examples of low-density polyethylene include Tosoh Corporation's Petrocene (trade name) series. Specific examples of high-density polyethylene include Prime Polymer Co., Ltd.'s Hi-Zex (trade name). Series. High density polyethylene having a density (g / cm ³ ) in the range of 0.947-0.964 is particularly preferable.

[0022] 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 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. It is. From the viewpoint of versatility, for example, bands of a plurality of types of specific sizes such as S size (25 mm), M size (30 mm), and L size (35 mm) may be prepared. The thickness of the flexible band 1 (C in FIG. 2) is such that the band deforms moderately while having a waist, force, etc. About 0.5 to 3.0 mm force << preferably, 1 · 0 to 2 · More preferably about 0 mm, more preferably about 1 · 0 to 1.5 mm, particularly preferably about 1.3 to 1.5 mm.

[0023] 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 ( D) in Fig. 2 is not particularly limited, but it is recommended that the adhesive is sufficiently embedded in the groove 12b and that the band under the groove 12b is not too thin. ; · 5mm is preferred. The pitch of convex teeth 12a (E in Fig. 2) is preferably about 1.2 to 2.0 mm, and the opening width of grooves 12b between adjacent convex teeth 12a (F in Fig. 2) is About 0.5 to 0.8 mm is preferable. As shown in FIG. 2, the convex teeth 12a are preferable to have a tapered shape with inclined side surfaces from the viewpoint of embedding the adhesive into the grooves 12b, but the side surfaces are vertically cut. Also good. In addition, as shown in FIG. 9, when the convex tooth row 12 is formed only on the end portions 1A and IB to be the adhesive portions of the flexible band 1, the length of the end portions 1A and IB on which the convex tooth row 12 is formed. The length (G in FIG. 9) is preferably 4 to 10 mm. Snow In other words, in the present invention, the lengths (length in the axial direction) of the end portions 1A and IB that are the bonding portions of the flexible band 1 are preferably about 4 to 10 mm.

[0024] The adhesive 30 is not particularly limited as long as it is substantially harmless and does not easily reduce the adhesive force even in the oral cavity. However, the adhesive 30 is widely used for dentistry because it is easy to handle. Acrylic or epoxy type room temperature polymerization resin is preferred, and acrylic type room temperature polymerization resin is particularly preferred. Preferable specific examples of the acrylic room temperature polymerization resin include, for example, UniFirst II Clear (trade name) manufactured by GS Co., Ltd.

[0025] The material of the cap 20 is not particularly limited, and a molded product of a general-purpose resin can be used, but a preferable specific example in which an acrylic resin is preferable from the viewpoint of adhesiveness with the adhesive 30 is an example. , Kuraray Co., Ltd., and Como Glass.

[0026] Prior to adhering the end portions 1A and IB of the flexible band 1 to the splint (maxillary splint, mandibular splint), the areas to be adhered on the surfaces of the maxillary and mandibular splints are roughened with a file or the like. It is also preferable to apply a primer application treatment (primer treatment). By performing such surface roughening and primer treatment, the band 1A and IB force of the flexible band 1 are firmly bonded and bonded to the maxillary and mandibular splints 50A and 50B, making the structure more stable and movable. A 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, when the upper jaw splint 50A is a polycarbonate mold, dichloromethane is preferred, and when the lower jaw splint is an acrylic resin mold, ethyl acetate is preferred.

As is apparent from the connector 100 of the first embodiment, according to the connector for a mandibular frontal-type intraoral device of the present invention, the end portions 1A and 1B of the flexible band 1 that is the connector body The upper and lower jaw sprints can be movably connected simply by adhering to the side of the sprint (upper jaw sprint, lower jaw sprint), so it is easy to operate and requires less time to wear. be able to. In other words, in the case of a conventional movable mandibular anterior intraoral device, 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. If it is the connector of the present invention, the flexibility that is the connector body Since the end 1A and IB of band 1 are simply adhered to the side of the sprint, it is easy to operate and requires less time to complete the installation. In particular, by using a polyethylene band for the flexible band that is the connector body, the sprint can be moved smoothly because the flexible band is easily deformed. 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, modified examples of the present invention will be described.

FIG. 11 shows the end portion of the flexible band in the connector for a mandibular front-oral-type intraoral device according to the second embodiment of the present invention. FIG. 11 (a) is a schematic diagram of the first plane, and FIG. FIG. 2C is a schematic diagram of a side surface. FIG. That is, the mandibular front-facing connector for oral cavity placement according to the second embodiment has both axial end portions 1A and IB sprints (upper jaws) that are adhesive portions of the flexible raw band 1 to the sprint (upper jaw sprint, lower jaw sprint). The first surface 11 which is the surface to be bonded to the sprint (mandible sprint) is a first surface 11 in which a plurality of convex teeth 12 a whose axis L2 is orthogonal to the axis L1 of the flexible band 1 are arranged side by side. While forming the convex tooth row 12, a plurality of convex teeth 14a whose axis L3 is parallel to the axis L1 of the flexible band 1 are arranged in parallel on the second surface 13 opposite to the first surface. The second convex tooth ridge IJ 14 (that is, the second convex tooth ridge IJ 14 intersecting the first convex tooth row 12) is formed, and the groove between adjacent convex teeth of the first convex tooth row 12 is formed. The bottom part of 12b and the bottom part of the concave groove 14b between adjacent convex teeth of the second convex tooth row 14 are communicated. Note that FIG. 12 is a schematic plan view of the second surface 13 of the flexible band 1, and the hatched region denoted by reference numeral 15 is visible in the concave groove 14b, and the bottoms of the concave groove 12b and the concave groove 14b are shown in FIG. A hole formed by communication is shown.

[0029] In the case of the connector for the mandibular frontal oral appliance in the second embodiment, the end of the flexible band 1 used in the connector for the mandibular frontal intraoral device in the first embodiment is used. It is possible to eliminate the need for the cap 20 on the top. That is, the end portions 1A and 1B of the flexible band 1 are applied to the surface (first surface 11) on the bonding side to the splint (maxillary splint, mandibular splint) and the splint (maxillary splint, When pressed against the lower jaw sprint, the adhesive leaks into the concave groove 14b on the second surface 13 side of the flexible band 1 through the hole 15, and the leaked adhesive is solidified to be firmly bonded. Since the force can be obtained, the structure can be stable without using a cap as in the first embodiment of the connector for an oral device of the lower jaw. A dynamic mandibular forward orientation intraoral device can be achieved. Therefore, in the movable mandibular frontal oral device obtained by using the connector for the mandibular frontal oral appliance in 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 at the joint (joint part), force S can be used to reduce discomfort during wearing.

[0030] It should be noted that in the connector for the mandibular front-oral-type intraoral device of 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 the adhesive, The pretreatment (sprint roughening treatment, primer treatment) and the like are followed as they are for the connector for the lower jaw front-oral-type intraoral device in the first embodiment. Further, 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 0.25-0.64 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 third embodiment of the connector for a mandibular frontal-type intraoral device has a plurality of through-holes at both ends 1A and IB in the axial direction to the sprint of the flexible band 1 (maxillary sprint, mandible sprint). A thin piece member 16 having 17 is fixed, and the thin piece member 16 is adhered to a splint (upper jaw splint, lower jaw splint) with an adhesive.

[0032] In the case of the connector for the mandibular frontal-type intraoral device of the third embodiment, a flexible band

1 end portion 1A, thin plate member 16 having a plurality of through-holes 17 fixed to IB. Adhesive is applied to one surface 16A of adhesive flat plate portion 16a to sprint thin piece member 16 (upper jaw splint, lower jaw splint). ) Through the through hole 17, the adhesive overflows to the other surface 16B of the bonding flat plate portion 16a, solidifies in a state where the other surface 16B is covered with the adhesive, and the thin piece member 16 ( Adhesive plate 16a) adheres firmly to the splint (maxillary splint, mandibular splint). Therefore, it is possible to achieve a movable mandibular frontal-type intraoral device that is stable as a structure without using a cap as in the connector for the lower-frontal type oral appliance in the first embodiment. Therefore, the movable mandibular frontal-type intraoral device obtained using the connector for mandibular frontal-type intraoral device of the third embodiment is also the mandible of the second embodiment. As with the connector for the forward-facing type intraoral device, the adhesive part (joint part) of the flexible band 1 to the splint (maxillary splint, mandibular splint) is not covered with a cap. Discomfort can be further reduced.

[0033] The material of the flake member 16 can be a biocompatible resin, metal, ceramic material, and the like. Specifically, a molded body such as polysulfone resin, fluororesin, silicone resin, titanium, stainless steel, platinum, etc. 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 16b, and the gripping portion 16b is caulked and crimped to the end portions 1A and IB 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. Further, the length in the same direction as the axial direction of the flexible band 1 of the bonding flat plate portion 16a (H in FIG. 13) is preferably about 4.0 to 10. Omm. Further, the through hole 17 may have a square shape 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 diameter (diameter) is preferably 1.0 to 1.5 mm).

[0035] In the connector for the mandibular front-orientation type intraoral device of the third embodiment, the material and dimensions of the flexible band 1, the type of the adhesive, the pre-treatment before bonding (sprint roughening treatment, The primer processing) is followed as it is in the connector for an oral device of the lower jaw in 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.

[0036] As can be seen from the above description, in the connector for a mandibular frontal-type intraoral device of the present invention, the upper and lower jaw splints can be obtained simply by bonding the end of the flexible band, which is the connector body, to the side surface of the splint. Since the movable mandibular orientation type intraoral device can be completed by connecting the devices, the movable mandibular orientation type intraoral device that is easy to operate and requires less time can be attached to the patient on the spot.

In addition, the connection means of the maxillary splint and the mandibular print in the conventional movable mandibular frontal-type intraoral device is attached to the sprint when it is manufactured. On the other hand, the connector for a mandibular frontal oral appliance of the present invention is bonded to the prepared maxillary splint and the mandibular splint with an adhesive later, so It is easy to change and repair, and the connector for mandibular frontal oral appliance of the present invention can be attached later to the fixed mandibular frontal intraoral device in use. It is also possible to change to a device.

Example

Hereinafter, the present invention will be described more specifically with reference to examples and comparative examples.

A tensile test was conducted with the connector of the present invention in clinical condition, and the fracture site was confirmed and the fracture load was measured. As a comparison object, a conventionally known movable mandibular frontal oral cavity device ("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 conducted using.

Details! /, Test contents are as follows.

[0038] [Test 1]

1.Material used

(A) To-be-connected body: Polycarbonate (PC) flat plate (manufactured by Joydental, “Imperon S”). Thickness: 2. Omm, Width: 15mm, R: 50mm

(B) Flexible band

Band 1: Thickness: 1.3 mm, Width: 4. Omm, 35 mm long soft belt (Tosohichi Co., Ltd., “Petrocene”, low density polyethylene)

Node 2: Thickness: 1.3 mm, width: 4. Omm, 35 mm long rigid belt (Prime Polymer, “Hitustus 5100E”, high density polyethylene),

(C) Adhesive

Acrylic room temperature polymerization resin (Guni Co., Ltd. “UNI FIRST II CLEAR”)

PC Adhesive (Sankin Co., Adhesive Treatment for Polycarbonate (Primer))

(D) Cap

Acrylic resin cap (Kuraray Co. Glass)

(E) Conventionally known movable mandibular frontal oral appliance (silencer) Sprint part: Ercodeur (trade name) (manufactured by Elcodent, material: cellulose acetate butyrate)

Part of the connector: Silencer (trade name) (manufactured by Elcodent, material: polyoxymethylene copolymer) i) The silencer consists of three parts: a connector, a stopper, and a shell.

[0039] 2. Test method

The object to be connected was regarded as a sprint, and two of them were connected with the connector of the present invention to prepare a sample for a tensile test.

Samples were prepared under two conditions using band 1 (soft belt) and band 2 (hard belt).

[0040] That is,

Example 1 (Sample 1): Adhering both ends (length: 35 mm) of band 1 to an object to be connected (Imperon S) using an adhesive and a cap.

Example 2 (Sample 2): Adhering both ends (length: 35 mm) of belt 2 to an object to be connected (Imperon S) using an adhesive and a cap.

Two types of samples were prepared.

[0041] Similarly, as Comparative Example 1 (Sample 3), an Elcodeur 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. It connected by the predetermined connection method employ | adopted.

FIG. 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 connecting part of Samples 1 and 2 has a structure in which the end of the band 62 is fixed to the connected body 61 with an adhesive 63 and a cap 64 (FIG. 14).

On the other hand, the connecting part of sample 3 is the structure adopted by Elcodeur (manufactured by Elcodent), and through-hole 72 is formed at a predetermined part of the coupled body (Elcodeur) 71 made of CA (cellulose acetate butyrate). Then, a through hole 74 is formed at the end of the connector 73, aligned so that the axes of the through hole 72 and the through hole 74 are aligned, and the shell 75 and the stopper 76 are inserted into the through hole from both sides of the through hole. By inserting and fitting, the connected body 71 and the connector 73 are connected (FIG. 15). [0043] 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, arrow A indicates the axial direction of pulling, and arrow B indicates the direction perpendicular to the axis.

[0044] Seven samples each of!; To 3 were prepared and tested seven times. The tensile test was performed using a universal testing machine AGSIOKNG (SHIMAZU), measuring the breaking load at a crosshead speed of 25 mm / min and observing the fracture site.

[0045] Table 1 shows the breaking load and the breaking site of each sample.

[0046] [Table 1]

[0047] The greatest tensile strength in the axial direction was 126. 7 ± 1 2.2 N of the silencer (Sample 3). Next, the connecting 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 connecting body of the connector of the present invention using a soft belt ( It was 55.4 ± 0 · 7N of sample 1).

[0048] The largest tensile strength in the direction perpendicular to the shaft was 81.0 ± 3 · 9N of the connection body (sample 2) by the connector of the present invention using a hard belt. Next, 55.8 ± 1 · 5 N, the smallest value of the connection body (sample 1) with the connector of the present invention using a soft belt. It was 35 · 9 ± 2 · 5N of the silencer (Sample 3).

[0049] With tensile in the axial direction, the belt part was broken in both sample 2 using a hard belt, sample 1 using a soft belt, and silencer (sample 3).

[0050] When pulling in the direction perpendicular to the shaft, in sample 2 using a hard belt, the connection cap was damaged in all seven samples, and in sample 1 using a soft belt, all seven samples were The belt broke. In the connection using the silencer, the stoppers of the connection parts were damaged in all seven samples.

[0051] With the connector of the present invention, the connector is pulled in the axial direction in a conventional mandibular frontal oral cavity device such as a mandibular frontal oral device and a “silencer” in which the maxillary splint and the mandibular splint are connected by the connector of the present invention. This corresponds to the load during the backward movement of the lower jaw, and the pull in the axis and vertical direction is considered to correspond to the load during the lateral movement of the lower jaw.

[0052] In the tensile test of the connector in the axial direction, sample 1 using a soft belt, sample 2 using a hard belt, and silencer (sample 3) were broken at the connecting shaft part of the device. As a result of comparison, the breaking strength (load) was in the order of silencer, sample 2 using a hard belt, and sample 1 using a soft belt.

[0053] 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 between the connector and the splint of the connector. Depending on the strength, the low strength portion was destroyed. In sample 2 using a hard belt, the cap of the connecting part was broken, and in sample 1 using a soft belt, the belt was broken. In the silencer (Sample 3), the destruction concentrated on the stopper of the connecting part.

[0054] 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, the belt of Sample 2 using a soft belt is used. The strength (55.8 N) when pulled in the direction perpendicular to the axis is the strength of the device. From the same point of view, the strength of the silencer (Sample 3) is 35.9N. Based on this result, the mandibular prosthetic type oral appliance that connects the maxillary splint and the mandibular splint with the connector of the present invention is about 1.5 times stronger than the conventional mobile mandibular prosthetic type oral appliance (silencer). It is thought that it has strength and can be used safely in clinical practice. [0055] [Trial 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 body to be connected, and ethyl acetate was used as the adhesive treatment agent. Sample 5 (Example 4) was prepared, the same tensile test was performed, the breaking load was measured, and the fracture site was observed. The results are shown in Table 2 below.

[0056] [Table 2]

[0057] As can be seen from Table 2, in Test 2, the same results as in Test 1 were obtained, and the mandibular front orientation type obtained by connecting the maxillary splint and the mandibular splint with the connector of the present invention regardless of the material of the splint. Intraoral devices can be used safely in clinical practice.

[0058] [Clinical evaluation]

Out of 76 patients diagnosed with sleep apnea syndrome (56 males, 20 females), mandibular anterior orientation by examination and X-ray examination (panoramic X-ray 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. Among the 55 persons, the connector of the first embodiment of the present invention (flexible band: hard belt (manufactured by Prime Polymer, “Hitustus 5100E”, high-density polyethylene belt), adhesive: acrylic-based room temperature Mandibular frontal oral cavity device made by connecting upper and lower jaw sprints with a polymerized resin (manufactured by Gichi Co., Ltd., “First First Clear”), cap: acrylic resin cap (Kuraray Co., Ltd., Comoglass)) There were 22 cases using Of these, nine cases were changed from the conventional upper / lower jaw fixed type device to the mandibular frontal type oral device using the connector of the present invention.

In all 22 cases, improvements in subjective symptoms were observed, including reduced snoring and reduced daytime sleepiness. In addition, there are currently 10 cases that can be evaluated by overnight polysomnography after wearing, and the improvement rate of Apnea hypoapnea index (AHI) is 50 in all cases. It was effective at over%.

In addition, in a case where the mandibular frontal oral appliance using the conventional maxillary and maxillary splint fixation method (resin fixation) was changed to the mandibular frontal oral device using the connector of the present invention, the masseter muscle tension during waking up The feeling was improved and 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

The scope of the claims

[1] Put the upper and lower jaw sprints, made of resin or elastomer mold, with a connector that allows the upper and lower jaws to be opened and closed while keeping the lower jaw in the forward orientation.

A cap that covers each end of the flexible band;

[2] The connector for a mandibular frontal 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 the flexible band. .

[3] 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.

[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 with improved sleep apnea syndrome or snoring according to claim 1 or 2.

[5] Put the upper and lower jaw sprints made of resin or elastomer mold together with a connector to connect the upper and lower jaws so that they 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 to be attached to the maxilla or the mandibular splint at both ends. Forming a first convex tooth row on the surface, and forming a second convex tooth row intersecting the first convex tooth row on the second surface opposite to the first surface; Adjacent convex row A flexible band that connects the bottom of the groove between the convex teeth and the bottom of the groove between adjacent convex teeth of the second convex tooth row,

[6] The connector for an oral appliance of the mandibular frontal jaw type for sleep apnea syndrome according to claim 5, wherein the flexible band is a polyethylene band or!

[7] The sleep 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. Apnea Syndrome or! /, Snoring improvement mandibular frontal connector for intraoral device.

[8] A connector for connecting an upper jaw and a lower jaw splint made of a resin or elastomer mold so that the upper jaw and the lower jaw can be opened and closed while keeping the lower jaw in the forward orientation.

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 adhered to the vicinity of the molar portion of the mandibular splint. Adhesive with adhesive, force, adhesive with adhesive, and embedded in multiple through-holes in the thin piece member. Connector for internal device.

[9] The connector for an oral appliance of the mandibular anteroposterior direction in which sleep apnea syndrome or! /, Snoring disease is improved, according to claim 8, wherein the flexible band is a polyethylene band.

[10] The upper jaw splint is a polycarbonate mold and the lower jaw splint is made of acrylic resin. The sleep apnea symptom group or snoring amelioration mandible according to claim 8, wherein the flexible band is a polyethylene band, the adhesive is a dental room temperature polymerization resin, and the flake member is made of titanium. Front-facing intraoral device connector.

The connector for a mandibular frontal-orientation type oral cavity device for improving sleep apnea syndrome or snoring according to any one of claims 10 to 10, wherein the adherend regions of the maxillary splint and the mandibular splint are preliminarily treated with a primer.