Designing and manufacturing method of oral cavity device for obstructive sleep apnea treatment

Abstract

To easily design and manufacture an optimum oval cavity device for obstructive sleep apnea treatment suitable for the skeleton of each patient.SOLUTION: A method for designing an oral cavity device for obstructive sleep apnea treatment on a computer from three-dimensional shape data on a patient oral cavity defined in a three-dimensional coordinate space includes: a step for acquiring the upper jaw shape data UJ and the lower jaw shape data LJ of a patient; a step for acquiring occlusion data BTS on the lower jaw initial position in the state that the lower jaw is opened from the central occlusion point; a step for acquiring occlusion data BTE on the lower jaw maximum protraction position in the state that the lower jaw is moved forward to the maximum while it is kept opened; and a step for designing a plurality of oral cavity devices in which the positions of the lower jaw with respect to the upper jaw are all different from the upper jaw shape data UJ, the lower jaw shape data LJ, the occlusion data BTS, and the occlusion data BTE.SELECTED DRAWING: Figure 10a1

Description

[Technical Field]

[0001] The present disclosure relates to a method for manufacturing an oral appliance, and more particularly to a method for designing and manufacturing an oral appliance suitable for improving the symptoms of obstructive sleep apnea. [Background technology]

[0002] Obstructive sleep apnea (OSA) is a sleep disorder characterized by the obstruction of the upper airway due to tongue retraction during sleep, resulting in apnea. OSA, which causes daytime headaches and drowsiness and can lead to chronic conditions such as high blood pressure, has become widely recognized as a social disorder. The primary treatment for OSA is continuous positive airway pressure (CPAP) administered by both internal medicine and respiratory medicine. However, for mild to moderate cases, oral appliances that move the lower jaw forward to suppress tongue retraction and prevent upper airway obstruction are also effective.

[0003] The forward movement of the mandible in oral appliances for the treatment of obstructive sleep apnea must be set for each patient, as the state of the upper airway, skeletal characteristics, and restrictions vary from patient to patient. The greater the forward movement of the mandible, the greater the treatment effect, but in exchange, excessive strain is placed on the patient's jaw, which can lead to the risk of developing temporomandibular joint disorder. Therefore, it is necessary to prevent upper airway obstruction with minimal forward movement of the mandible.

[0004] To set the optimal forward movement of the mandible, separate mouthpieces for the upper and lower jaws must be made, and the dentist must then move the lower mouthpiece forward relative to the upper mouthpiece, glue the upper and lower mouthpieces together, and place them on the patient.If the patient complains of discomfort or pain in the temporomandibular joint, the upper and lower mouthpieces must be separated, readjusted, and glued together.This process must be repeated, and the current situation is that these procedures increase chair time and place a burden on both dentists and patients.

[0005] Patent Document 1 describes a method of determining the opening value of a patient's upper airway when wearing a protruding splint that fixes the lower jaw in a state (first position) where it is moved forward relative to the upper jaw compared to the patient's normal position, comparing the determined opening value with a target value, and if it is below the target value, determining the advancement value of the lower jaw again, moving the lower jaw further forward from the first position to determine a second position, and manufacturing a protruding splint in the second position. It also states that in order to prevent temporomandibular joint disorders, the condition of the temporomandibular joint is examined in the first and second positions, and if temporomandibular joint damage is likely to occur even if the opening value in the second position exceeds the target value, the position of the mandible is adjusted by redefining the second position. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] Patent No. 6253679 Summary of the Invention [Problem to be solved by the invention]

[0007] Determining the position of the lower jaw in a protrusion-type splint taking into account the opening value of the upper airway and the load on the temporomandibular joint is a suitable means for treating obstructive sleep apnea as an oral device; however, the opening value and temporomandibular joint when wearing a protrusion-type splint that fixes the first position must be measured and observed using an X-ray device or the like, which not only increases chair time and the burden on the patient, but also makes it cumbersome as it is necessary to prepare in advance a protrusion-type splint that fixes the first position for measurement and observation. In addition, the direction in which the lower jaw should be advanced relative to the upper jaw is not specified, so whether the direction of advancement is appropriate for the patient's skeleton can only be determined by observing the patient's temporomandibular joint, which requires advanced knowledge. The present invention has been made with the object of solving the above problems. [Means for solving the problem]

[0008] The present invention provides a method for designing an oral appliance for treating obstructive sleep apnea on a computer from three-dimensional shape data of a patient's oral cavity defined in a three-dimensional coordinate space, the method comprising: obtaining upper jaw shape data UJ and lower jaw shape data LJ of a patient; A step of obtaining occlusion data BTS of the initial position of the lower jaw in a state where the lower jaw is opened from the centric occlusion position; a step of obtaining occlusion data BTE at the maximum mandibular protrusion position when the mandibular jaw is moved forward to the maximum extent while maintaining the mouth opening; a step of designing a plurality of intraoral appliances, each having a different position of the mandible relative to the maxilla, based on the maxilla shape data UJ, the mandible shape data LJ, the occlusion data BTS, and the occlusion data BTE; A method for designing an oral appliance for treating obstructive sleep apnea, comprising:

[0009] More preferably, the present invention relates to A method for designing an oral appliance for treating obstructive sleep apnea from three-dimensional shape data of a patient's oral cavity defined in a three-dimensional coordinate space, comprising: obtaining upper jaw shape data UJ and lower jaw shape data LJ of a patient; A step of obtaining occlusion data BTS of the initial position of the lower jaw in a state where the lower jaw is opened from the centric occlusion position; a step of obtaining occlusion data BTE at the maximum mandibular protrusion position when the mandibular jaw is moved forward to the maximum extent while maintaining the mouth opening; a process of shape-matching the maxillary shape data UJ and the mandibular shape data LJ with the occlusion data BTS to obtain intraoral data OS consisting of the maxillary shape data UJS and the mandibular shape data LJS at the initial position of the mandible; a process of shape-matching the maxillary shape data UJ and the mandibular shape data LJ with the occlusion data BTE to calculate intraoral data OE consisting of the maxillary shape data UJE and the mandibular shape data LJE at the mandibular maximum protrusion position; a process of shape-matching the maxillary shape data LJE of the intraoral data OE with the maxillary shape data UJS of the intraoral data OS, reading the intraoral data OE into the three-dimensional coordinate space of the intraoral data OS, and calculating the mandibular displacement data FJ; a step of calculating a maximum mandibular protrusion displacement LMD from the positional relationship between the mandibular shape data LJS of the initial position of the mandibular jaw in the mandibular displacement data FJ and the mandibular shape data LJE of the maximum mandibular protrusion position; A step of calculating a mandibular path LR for designing an intraoral appliance from the mandibular maximum protrusion displacement LMD; A step of calculating a start point SP corresponding to the initial position of the mandible on the mandibular path LR and an end point EP corresponding to the maximum mandibular protrusion position; A step of setting an arbitrary design end position DEP different from the start point SP and the end point EP on the mandibular path LR; A step of calculating a device design path ADR from a start point SP to a design end position DEP on the mandibular path LR; setting a plurality of design intermediate positions DMP different from the start point SP and the design end position DEP on the equipment design path ADR; A step of calculating a design intermediate displacement DMD from the start point SP to each of a plurality of design intermediate positions DMP; calculating a design end displacement DED from the start point SP to the design end position DEP; a step of calculating a plurality of intermediate device design data AM by moving the mandibular shape data LJS in the intraoral data OS based on the design intermediate displacement DMD; A step of moving the mandibular shape data LJS in the intraoral data OS based on the design end displacement DED and calculating end device design data AE; a step of designing a plurality of intraoral devices, each having a different position of the mandible relative to the maxilla, based on the intraoral data OS, each intermediate device design data AM, and each terminal device design data AE; A method for designing an oral appliance for treating obstructive sleep apnea, comprising:

[0010] The present invention also provides This is a method for designing an oral appliance for treating obstructive sleep apnea, characterized in that a start point SP is set to the center point of a bounding box BBS of mandibular shape data LJS in mandibular displacement data FJ, and an end point EP is set to the center point of a bounding box BBE of mandibular shape data LJE in mandibular displacement data FJ. [Effects of the Invention]

[0011] According to the present invention, the direction in which the lower jaw should be advanced can be determined from the patient's upper jaw shape data UJ, lower jaw shape data LJ, occlusion data BTS for the initial position of the lower jaw, and occlusion data BTE for the maximum protrusion position of the lower jaw.In addition, it is possible to easily design and manufacture an optimal oral device for treating obstructive sleep apnea that suits the individual skeletal structure of each patient. [Brief explanation of the drawings]

[0012] [Figure 1] Side and oblique views of upper jaw shape data UJ [Figure 2] Side and oblique views of lower jaw shape data LJ [Figure 3] Side and oblique views of the occlusion data BTS for the initial position of the lower jaw [Figure 4] Side view and perspective view when the upper jaw shape data UJ and the lower jaw shape data LJ are shape-matched to the occlusion data BTS of the lower jaw initial position [Figure 5] Side and oblique views of the occlusion data BTE at the maximum mandibular protrusion position [Figure 6] Side view and perspective view when the maxillary shape data UJ and mandibular shape data LJ are shape-matched to the occlusion data BTE at the mandibular maximum protrusion position [Figure 7] Side and oblique views of the intraoral data OE of the maximum mandibular protrusion position loaded into the three-dimensional coordinate space of the intraoral data OS of the initial mandibular position. [Figure 8a] A perspective view of the maxillary shape data UJE at the maximum mandibular protrusion position when shape-matching the maxillary shape data UJS at the initial mandibular position intraoral data OS. [Figure 8b]Sagittal cross section of Fig. 8a [Figure 8c] Sagittal cross section of mandibular displacement data FJ obtained by deleting maxillary shape data UJE at the maximum mandibular protrusion position from Fig. 8a [Figure 9a1] A perspective view showing the bounding box BBS and starting point SP of the mandibular shape data LJS for the initial position of the mandibular position in the mandibular displacement data FJ. [Figure 9a2] Sagittal cross section showing the bounding box BBS and starting point SP of the mandibular shape data LJS for the initial position of the mandible in the mandibular displacement data FJ [Figure 9b1] A perspective view showing the bounding box BBE and end point EP of the mandibular shape data LJE at the maximum mandibular protrusion position in the mandibular displacement data FJ. [Figure 9b2] Sagittal cross section showing the bounding box BBE and end point EP of mandibular shape data LJE at the maximum mandibular protrusion position in mandibular displacement data FJ [Figure 10a1] A perspective view showing the mandibular path LR connecting the starting point SP and the ending point EP [Figure 10a2] Sagittal cross section showing the mandibular path LR connecting the starting point SP and the ending point EP [Figure 10b1] A perspective view showing the design end position DEP defined on the mandibular path LR and the device design path ADR connecting the start point SP and the design end position DEP. [Figure 10b2] A sagittal cross-sectional view showing the design end position DEP defined on the mandibular path LR and the device design path ADR connecting the starting point SP and the design end position DEP. [Figure 10c1] A perspective view showing a plurality of design intermediate positions DMP set on the equipment design route ADR. [Figure 10c2] A sagittal cross-sectional view showing multiple design intermediate positions (DMP) set on the device design path (ADR). [Figure 10d] Enlarged view of the sagittal cross section of Figure 10c (mandibular shape data not shown) [Figure 11a] Design example of oral appliance OAS in intraoral data OS of mandibular initial position (transparent for convenience) [Figure 11b]Design example of intraoral device OAE in end device design data AE at design end position DEP (shown transparently for convenience) [Figure 11c] Design example of oral device OAM in intermediate device design data AM at any position of multiple design intermediate positions DMD (transparent display for convenience) [Figure 11d] A design example of an intraoral appliance AMz in intermediate appliance design data AMz in which the opening amount has been adjusted by adjusting the position of the start point SP and end point EP in the opening direction in three-dimensional coordinate space (shown transparently for convenience) [Explanation of symbols]

[0013] UJ Upper jaw shape data LJ Lower jaw shape data BTS Mandibular initial position occlusion data BTE occlusion data for maximum mandibular protrusion position OS Intraoral data of mandibular initial position OE Intraoral data of maximum mandibular protrusion position UJS Maxillary shape data in intraoral data of mandibular initial position LJS Mandibular shape data in the intraoral data of the mandibular initial position UJE Maxillary shape data in the intraoral data of the maximum mandibular protrusion position LJE Mandibular shape data in the intraoral data of the maximum mandibular protrusion position FJ Mandibular displacement data LMD Maximum mandibular protrusion displacement LR Mandibular Path SP starting point EP End Point BBS Bounding box of mandibular shape data for initial position of mandibular position in mandibular displacement data Bounding box of mandibular shape data at maximum mandibular protrusion position in BBE mandibular displacement data DEP design end position ADR Device Design Path DMP design intermediate position DMD design mid-displacement DED Design End Displacement AM intermediate equipment design data AE terminal device design data OAS Oral appliance for mandibular initial position OAE Design End Position Oral Appliance OAM Design Intermediate Position Oral Appliance DETAILED DESCRIPTION OF THE INVENTION

[0014] Hereinafter, an embodiment of the present invention will be described with reference to the drawings. FIG. 1 is a side view and a perspective view of the patient's upper jaw shape data UJ defined in a three-dimensional coordinate space, and FIG. 2 is a side view and a perspective view of the patient's lower jaw shape data LJ defined in a three-dimensional coordinate space. In order to properly design an oral device for treating obstructive sleep apnea, it is preferable that the upper jaw shape data UJ and the lower jaw shape data LJ include all of the teeth present in the patient's oral cavity as three-dimensional shapes. The upper jaw shape data UJ and the lower jaw shape data LJ do not necessarily need to represent the actual positional relationship between the upper and lower jaws in the patient's oral cavity in a three-dimensional coordinate space. That is, when the lower jaw shape data LJ is read into the three-dimensional coordinate space of the upper jaw shape data UJ, the upper and lower jaws do not need to be in the same positional relationship in the oral cavity of the patient.

[0015] FIG. 3 shows a side view and a perspective view of the occlusion data BTS of the initial position of the lower jaw in a state where the lower jaw is opened from the centric occlusion position defined in the three-dimensional coordinate space. The occlusion data BTS defines the positional relationship between the upper and lower jaws in the initial position of the lower jaw in the patient's oral cavity in the same three-dimensional coordinate space. The occlusion data BTS is preferably shape data consisting of approximately 2 to 3 teeth on each side of the upper jaw and approximately 2 to 3 teeth on each side of the lower jaw from the patient's premolars to molars, and the front teeth do not need to be included in the occlusion data. The occlusion data BTS preferably indicates a positional relationship in which there is no forward movement of the lower jaw relative to the upper jaw, and the lower jaw only opens. The opening amount of the occlusion data BTS must be such that the maxillary and mandibular dentition do not come into contact when the mandible is advanced, and it is preferable that it be 5 mm or less, taking into consideration the patient's fit and comfort, the strength of the oral appliance, and the treatment effect.

[0016] FIG. 4 shows a side view and a perspective view when the upper jaw shape data UJ and the lower jaw shape data LJ are shape-matched with the occlusion data BTS of the lower jaw initial position defined in three-dimensional coordinate space. By shape-matching the upper jaw shape data UJ and the lower jaw shape data LJ to the occlusion data BTS, the state of the patient's oral cavity at the initial position of the lower jaw is accurately reproduced. Shape matching is achieved by known techniques such as the local best fit function included in GOM Inspect Suite (GOM), which is evaluation software for 3D measurement data. This function allows you to select a common shape between the target's 3D shape and the 3D shape you want to align with the target when two 3D shape data have roughly the same shape but different positions and orientations, and then move the 3D shape you want to align with the target to the position where the common shapes overlap most. In the present invention, the occlusion data BTS of the initial position of the lower jaw is set to the three-dimensional shape of the target, the upper jaw shape data UJ and the lower jaw shape data LJ are set to the three-dimensional shapes to be matched to the target, and the common shape is selected for each tooth.By aligning the upper jaw shape data UJ and the lower jaw shape data LJ with the occlusion data BTS of the initial position of the lower jaw, intraoral data OS is calculated in which the initial position of the lower jaw in the patient's oral cavity is reproduced in three-dimensional coordinate space.

[0017] For convenience, the upper jaw and lower jaw in the intraoral data OS are referred to as upper jaw shape data UJS and lower jaw shape data LJS, respectively.

[0018] FIG. 5 shows a side view and a perspective view of the occlusion data BTE of the mandibular maximum protrusion position in which the mandibular jaw defined in the three-dimensional coordinate space has been moved forward to the maximum extent. The occlusion data BTE defines the positional relationship between the upper and lower jaws at the maximum mandibular protrusion position in the patient's oral cavity in the same three-dimensional coordinate space. The occlusion data BTE is preferably shape data consisting of approximately two to three teeth on each side of the upper jaw and two to three teeth on each side of the lower jaw from the patient's premolars to molars, and the front teeth do not need to be included in the occlusion data. It is preferable that the occlusion data BTE be within the range of motion of the patient's temporomandibular joint and within the range that does not damage the temporomandibular joint, and that the amount of opening is the maximum amount of advancement in a direction that is structurally natural for the patient's skeleton, and that the positional relationship be such that the opening amount is equivalent to the opening amount of the initial position of the mandible.

[0019] FIG. 6 shows a side view and a perspective view when the upper jaw shape data UJ and the lower jaw shape data LJ are shape-matched with the occlusion data BTE of the mandibular maximum protrusion position defined in three-dimensional coordinate space. By shape-matching the maxillary shape data UJ and mandibular shape data LJ with the occlusion data BTE, intraoral data OE that accurately reproduces the state of the patient's oral cavity at the maximum mandibular protrusion position is calculated. Shape matching is achieved using the functions described in Figure 4. For convenience, the upper jaw and lower jaw in the intraoral data OE are referred to as upper jaw shape data UJE and lower jaw shape data LJE, respectively.

[0020] It is preferable that the upper jaw shape data UJ, lower jaw shape data LJ, occlusion data BTS for the initial position of the lower jaw, and occlusion data BTE for the maximum protrusive position of the lower jaw are either three-dimensional scan data obtained by directly scanning the patient's oral cavity with an intraoral scanner, or three-dimensional scan data obtained by scanning a plaster model that reproduces the patient's oral cavity with a model scanner. When acquiring occlusion data BTS of the initial position of the lower jaw using an intraoral scanner, the occlusion data BTS can be data obtained by scanning the molar areas on both sides while a bite index made of dental silicone material or the like is attached to the anterior teeth in the patient's oral cavity and the opening amount is fixed, in order to fix the patient's upper and lower jaws in a position that maintains the opening amount of the lower jaw relative to the upper jaw as described in the explanation of Figure 3. When obtaining occlusion data BTE at the maximum mandibular protrusion position using an intraoral scanner, the occlusion data BTE can be data obtained by scanning the molar areas on both sides while the amount of opening is fixed by attaching a bite index made of dental silicone material or the like to the anterior teeth in the patient's oral cavity, in which the patient's upper and lower jaws are fixed in a position that maintains the direction, amount of advancement, and opening amount of the lower jaw relative to the upper jaw as described in the explanation of Figure 5. When acquiring the occlusion data BTS of the initial position of the lower jaw using a model scanner, the occlusion data BTS can be data obtained by scanning the state in which the upper jaw model and the lower jaw model are attached and fixed on an articulator in a position that maintains the opening amount of the lower jaw relative to the upper jaw as described in the explanation of Figure 3.

[0021] When acquiring occlusion data BTE for the maximum mandibular protrusion position using a model scanner, the occlusion data BTE can be data obtained by scanning the state in which the upper jaw model and the lower jaw model are mounted and fixed on an articulator in a position that maintains the direction, amount of advancement, and opening amount of the lower jaw relative to the upper jaw as described in the explanation of Figure 5.

[0022] In the present invention, the method of acquiring the upper jaw shape data UJ, the lower jaw shape data LJ, the occlusion data BTS, and the occlusion data BTE is not limited, and any known method may be used.

[0023] FIG. 7 is a perspective view showing a state in which intraoral data OE of the mandibular maximum protrusion position is read into the three-dimensional coordinate space of intraoral data OS of the mandibular initial position. The intraoral scanner and the model scanner each have their own unique three-dimensional coordinate system, and the acquired scan data is ultimately acquired at a random position relative to the origin coordinates of each unique three-dimensional coordinate system due to differences in the orientation of the scanner or the orientation of the patient in the case of an intraoral scanner, or differences in the orientation or height of the model in the case of a model scanner.As a result, the occlusion data BTS for the initial position of the mandible shown in Figure 4 and the occlusion data BTE for the maximum protruding position of the mandible shown in Figure 6 are also acquired at random positions. Therefore, the shape data of both the intraoral data OS and the intraoral data OE have a random positional relationship in the three-dimensional coordinate space. In the state shown in Figure 7, it is difficult to measure the relative positional relationship between the position of the mandibular shape data LJS at the initial position of the mandibular jaw and the position of the mandibular shape data LJE at the maximum mandibular protrusion position, so it is necessary to align the intraoral data OE at the maximum mandibular protrusion position with the three-dimensional coordinate space of the intraoral data OS at the initial position of the mandibular jaw.

[0024] FIG. 8a is a perspective view showing a state in which the upper jaw shape data UJE of the intraoral data OE at the maximum mandibular protrusion position is shape-matched with the upper jaw shape data UJS of the intraoral data OS at the initial mandibular position. Shape matching is achieved using the functions described in Figure 4. By shape matching, the position of the mandibular shape data LJS at the initial position of the mandibular jaw and the position of the mandibular shape data LJE at the maximum mandibular protrusion position can be calculated as relative displacements with respect to the maxillary shape data UJS or UJE in the same three-dimensional coordinate space.

[0025] FIG. 8b is a sagittal cross-sectional view of the state of FIG. 8a. By shape matching, the maxillary shape data UJS at the initial position of the mandible and the maxillary shape data UJE at the maximum protruding position of the mandible overlap, and the cross-sectional curves also match. Compared to the cross-sectional curve of the mandibular shape data LJS in the initial position of the mandible, the cross-sectional curve of the mandibular shape data LJE in the maximum mandibular protrusion position is forward, and this movement indicates the displacement of the mandibular advancement relative to the maxilla.

[0026] FIG. 8c is a sagittal cross-sectional view showing the state in which the upper jaw shape data UJE at the maximum mandibular protrusion position is deleted from the state of FIG. 8b, and this data is defined as mandibular displacement data FJ. In FIG. 7, the shading of the mandibular shape data in the intraoral data OE at the maximum mandibular protrusion position, which is displayed in a darker shade for the sake of convenience, is made to match the shading of the intraoral data OS at the initial mandibular position.

[0027] Figure 9a is an oblique view and a sagittal cross-section showing the bounding box BBS and starting point SP of the mandibular shape data LJS at the initial position of the mandibular jaw in the mandibular displacement data FJ of Figure 8c, and Figure 9b is an oblique view and a sagittal cross-section showing the bounding box BBE and ending point EP of the mandibular shape data LJE at the maximum mandibular protrusion position in the mandibular displacement data FJ. The bounding box is the smallest rectangular parallelepiped that can contain the three-dimensional shape data, and the intersection of its diagonals is the center point. Since the bounding boxes BBS and BBE are both created from the lower jaw shape data LJ, which is the same three-dimensional shape data, the shapes of the bounding boxes BBS and BBE are completely identical. Therefore, in the mandibular displacement data FJ, the displacement when the mandibular shape data UJS of the mandibular initial position relative to the maxillary shape data UJS moves to the mandibular maximum protrusion position can be calculated as the displacement of the end point EP relative to the start point SP. In other words, the mandible in the mandibular displacement data FJ at the initial mandibular position is at the position of the starting point SP, and the mandibular position at the maximum mandibular protrusion position is at the position of the ending point EP.

[0028] 10a shows a perspective view and a sagittal cross-sectional view of the mandibular path LR connecting the starting point SP and the ending point EP. The mandibular path LR is the path of the patient's mandible when it moves from the initial position to the maximum mandibular protrusion position, and since this trajectory is approximately straight, it is preferable that the mandibular path LR is also straight. The oral appliance according to the present invention is designed so that the mandible is within the range of the mandibular path LR, and therefore can be designed in harmony with the amount of movement and natural direction of movement of the patient's mandible.

[0029] FIG. 10b is a perspective view and a sagittal cross-sectional view showing the design end position DEP and the device design path defined on the mandibular path LR. Oral appliances designed for the position of the end point EP of the mandibular path LR, i.e., the position of maximum mandibular protrusion, are not recommended because they place excessive strain on the patient's temporomandibular joint. Therefore, it is preferable to set a design end position DEP that is different from the starting point SP and the ending point EP within the mandibular path LR, and to design the oral device by making the path from the starting point SP to the design end position DEP the device design path ADR, and to move the mandible within the range of the device design path ADR.In other words, it is preferable to set the displacement amount from the starting point SP to the design end position DEP to a position that is within the range of 50% to 80% of the displacement amount of the mandibular path LR. Moreover, it is preferable that the device design path ADR is a straight line, similar to the mandibular path LR. This makes it possible to design oral appliances for treating obstructive sleep apnea that take into account the strain on the temporomandibular joint for patients who are candidates for oral appliances.

[0030] Figure 10c is an oblique view and a sagittal cross-sectional view showing multiple design intermediate positions DMP set on the device design path ADR, and Figure 10d is an enlarged view of the sagittal cross-sectional view of Figure 10c, omitting the illustration of the mandibular shape data LJS and LJE. When determining the optimal oral appliance for each patient, it is preferable that the adjustment of the amount of mandibular advancement be a uniform increase or decrease, and that the increase or decrease is preferably 1 mm or less. Therefore, it is preferable that the design intermediate positions DMP set on the equipment design path ADR be set at positions that equally divide the equipment design path ADR, and it is preferable to set the design intermediate positions so that d / (s+1)≦1, where s is the number of design intermediate positions DMP and d (mm) is the displacement of the equipment design path ADR. Furthermore, since it is preferable that the adjustment amount be a number that is easy to understand for both the adjuster and the patient, the design end position DEP may be set so that d / (s+1) = 1, d / (s+1) = 0.75, or d / (s+1) = 0.5.

[0031] 10c and 10d show an embodiment in which four design intermediate positions DMP different from the start point SP and the design end position DEP are set, and for convenience, these are designated DMP1, DMP2, DMP3, and DMP4 in order from the point closest to the start point SP. From the positional relationship of each design intermediate position relative to the start point SP, displacements DMD1, DMD2, DMD3, DMD4 from the start point SP to each design intermediate position, and a design end displacement DED from the start point SP to the design end position DEP can be calculated. Based on the calculated design intermediate displacements DMD1 to DMD4, the mandibular shape data LJS in the intraoral data OS of the mandibular initial position can be moved, and the data after the movement can be calculated as intermediate device design data AM1 to AM4, respectively. Furthermore, based on the calculated end design displacement DED, the mandibular shape data LJS in the intraoral data OS of the mandibular initial position can be moved, and the data after the movement can be calculated as end device design data AE.

[0032] FIG. 11a shows an intraoral device OAS designed in the intraoral data OS of the initial position of the lower jaw, with the lower jaw shape data OS at the position of the starting point SP, that is, in a state where the lower jaw is not moving forward and only the mouth is open. In treating OSA, oral appliances force the position of the lower jaw forward during sleep, and patients often complain of difficulty returning the lower jaw to its original position after waking up, i.e., a state in which the lower jaw has not moved forward. For such patients, wearing an oral appliance OAS designed with the mandible at the starting point SP can be useful as it can be used as a repositioner splint to return the mandible to its original position.

[0033] FIG. 11b shows an oral appliance OAE designed for end appliance design data AE, and FIG. 11c shows an oral appliance for treating obstructive sleep apnea designed for appliance design data AM3. According to the present invention, by designing oral devices OAS, OAM1-4, and OAE for each of the oral data OS, intermediate device design data AM1-AM4, and terminal device design data AE, as shown in the examples, it is possible to design multiple oral devices for treating obstructive sleep apnea, all with different positions of the mandible relative to the maxilla.

[0034] FIG. 11d shows an intraoral appliance in which the opening amount has been adjusted by adjusting the positions of the start point SP and the end point EP in the opening direction in the three-dimensional coordinate space. After acquiring the occlusion data BTS and BTE, situations often arise where, in consideration of the treatment effect, it is desired to adjust only the opening amount without changing the amount and direction of the mandibular advancement. In the present invention, since it is possible to adjust the positions of the starting point SP and the ending point EP in the direction of mouth opening in three-dimensional coordinate space, it is possible to design oral devices for treating obstructive sleep apnea in which the amount of advancement and direction of movement of the mandible are the same, but the amount of mouth opening is different.

[0035] Furthermore, according to the present invention, in addition to the oral devices OAS, OAM1-4, and OAE designed for each of the intraoral data OS, intermediate device design data AM1-AM4, and terminal device design data AE as shown in the examples, new start points SPz and end points EPz whose positions are adjusted in the mouth opening direction can be set, and oral devices OASz, OAM1z-4z, and OAEz can be designed for each of the new intraoral data OSz, intermediate device design data AM1z-AM4z, and terminal device design data AEz calculated based on the start points SPz and EPz, respectively, thereby designing oral devices for treating obstructive sleep apnea in which the positions of the mandible relative to the maxilla are all different.

[0036] In the present invention, it is preferable that the oral device be an integrated type that is combined with the upper and lower jaws in order to stabilize the amount of advancement and direction of movement of the lower jaw relative to the patient's upper jaw during sleep, but the specific shape of the integrated oral device is not limited, and it may be any known shape. For example, the one-piece oral appliance shown in Figures 11a to 11d is completely sealed, but may have air vents near the front teeth and a larger space near the lingual side of the front teeth to accommodate the tongue. The upper jaw shape data and lower jaw shape data in each data for designing an oral appliance may be changed as appropriate. Specific changes include offsetting the shape data, blocking out undercut portions such as an embrasure wall, etc.

[0037] According to the present invention, it is possible to output three-dimensional data for a plurality of oral devices, each with a different position of the lower jaw relative to the upper jaw, and to manufacture them using a 3D printer. The 3D printer material can be any known material that can be used for oral appliances. A plurality of the manufactured oral appliances for treating obstructive sleep apnea can be fitted to a patient to determine an appropriate mandibular protrusion position. When using oral appliances to treat OSA, the amount of advancement of the lower jaw of the oral appliance must be finely adjusted for each patient, a process known as titration. However, by fitting multiple oral appliances manufactured according to the present invention to a patient, it becomes possible to easily and precisely adjust the amount of advancement of the lower jaw to an optimum level, making titration easier. [Industrial Applicability]

[0038] The method for designing an oral appliance for treating obstructive sleep apnea according to the present invention can be used as a design algorithm that can be used with any three-dimensional CAD software. Furthermore, the method for manufacturing an oral appliance for treating obstructive sleep apnea according to the present invention can contribute to reducing chair time and reducing the burden on patients in treating OSA.

Claims

1. A method for designing an oral appliance for treating obstructive sleep apnea on a computer from three-dimensional shape data of a patient's oral cavity defined in a three-dimensional coordinate space, comprising: obtaining maxillary shape data UJ and mandibular shape data LJ of a patient; A step of obtaining occlusion data BTS of an initial position of the lower jaw in a state where the lower jaw is opened from the centric occlusion position; obtaining occlusion data BTE for the maximum mandibular protrusion position when the mandibular jaw is moved forward to the maximum extent while maintaining the mouth opening; a step of designing a plurality of intraoral appliances each having a different position of the mandible relative to the upper jaw from the upper jaw shape data UJ, the lower jaw shape data LJ, the occlusion data BTS, and the occlusion data BTE; A method for designing an oral appliance for treating obstructive sleep apnea, comprising:

2. A method for designing an oral appliance for treating obstructive sleep apnea from three-dimensional shape data of a patient's oral cavity defined in a three-dimensional coordinate space, comprising: obtaining maxillary shape data UJ and mandibular shape data LJ of a patient; A step of obtaining occlusion data BTS of an initial position of the lower jaw in a state where the lower jaw is opened from the centric occlusion position; obtaining occlusion data BTE for the maximum mandibular protrusion position when the mandibular jaw is moved forward to the maximum extent while maintaining the mouth opening; A process of shape-matching the upper jaw shape data UJ and the lower jaw shape data LJ to the occlusion data BTS to calculate intraoral data OS consisting of the upper jaw shape data UJS and the lower jaw shape data LJS at the lower jaw initial position; A process of shape-matching the upper jaw shape data UJ and the lower jaw shape data LJ to the occlusion data BTE to calculate intraoral data OE consisting of the upper jaw shape data UJE and the lower jaw shape data LJE at the maximum mandibular protrusion position; A process of shape-matching the upper jaw shape data LJE of the intraoral data OE with the upper jaw shape data UJS of the intraoral data OS, reading the intraoral data OE into the three-dimensional coordinate space of the intraoral data OS, and calculating the mandibular displacement data FJ; A step of calculating a maximum mandibular protrusion displacement LMD from a positional relationship between the mandibular shape data LJS of the initial position of the mandibular jaw in the mandibular displacement data FJ and the mandibular shape data LJE of the maximum mandibular protrusion position; A process of calculating a mandibular path LR for designing an intraoral appliance from the mandibular maximum protrusion displacement LMD; A step of calculating a start point SP corresponding to the initial position of the mandible on the mandibular path LR and an end point EP corresponding to the maximum mandibular protrusion position; A step of setting an arbitrary design end position DEP different from the start point SP and the end point EP on the mandibular path LR; A step of calculating an apparatus design path ADR from a start point SP to a design end position DEP on the mandibular path LR; A step of setting a plurality of design intermediate positions DMP different from a start point SP and a design end position DEP on an equipment design path ADR; A step of calculating a design intermediate displacement DMD from the start point SP to each of a plurality of design intermediate positions DMP; A step of calculating a design end displacement DED from the start point SP to a design end position DEP; A step of calculating a plurality of intermediate device design data AM by moving the mandibular shape data LJS in the intraoral data OS based on the design intermediate displacement DMD; A step of moving the mandibular shape data LJS in the intraoral data OS based on the design end displacement DED to calculate end device design data AE; A step of designing a plurality of intraoral devices, each of which has a different position of the mandible relative to the upper jaw, based on the intraoral data OS, each intermediate device design data AM, and each end device design data AE; A method for designing an oral appliance for treating obstructive sleep apnea, comprising:

3. 3. The method for designing an oral appliance for treating obstructive sleep apnea according to claim 2, characterized in that the start point SP is set to the center point of a bounding box BBS of the mandibular shape data LJS in the mandibular displacement data FJ, and the end point EP is set to the center point of a bounding box BBE of the mandibular shape data LJE in the mandibular displacement data FJ.

4. 3. The method for designing an oral appliance for treating obstructive sleep apnea according to claim 2, wherein the mandibular maximum protrusion displacement LMD is determined by calculating the displacement of the end point EP relative to the start point SP.

5. The method for designing an oral device for treating obstructive sleep apnea as described in claim 2, characterized in that the start point SP and the end point EP allow position adjustment only in the opening direction in three-dimensional coordinate space and can be redefined and / or added.

6. 3. The method for designing an oral appliance for treating obstructive sleep apnea according to claim 2, characterized in that the mandibular path LR is a straight line connecting two points, the starting point SP and the end point EP, in three-dimensional coordinate space, and the device design path ADR set on the mandibular path LR is also a straight line.

7. 3. The method for designing an oral appliance for treating obstructive sleep apnea according to claim 2, characterized in that the design end position DEP is set at a position where the displacement from the start point SP to the design end position DEP is within a range of 50% to 80% of the displacement of the mandibular path LR.

8. The method for designing an oral appliance for treating obstructive sleep apnea as described in claim 2, characterized in that the multiple design intermediate positions DMP set on the appliance design path ADR are set at positions that equally divide the appliance design path ADR.

9. The method for designing an oral device for treating obstructive sleep apnea as described in claim 2, characterized in that a plurality of oral devices in which the positions of the mandible relative to the upper jaw are all different and designed based on the oral data OS, each intermediate device design data AM, and the terminal device design data AE are integrated to be combined with the upper and lower jaws.

10. The method for designing an oral device for treating obstructive sleep apnea as described in claim 1, characterized in that the upper jaw shape data UJ, the lower jaw shape data LJ, the occlusion data BTS of the lower jaw initial position, and the occlusion data BTE of the lower jaw maximum protrusion position are either three-dimensional scan data obtained by directly scanning the patient's oral cavity with an intraoral scanner, or three-dimensional scan data obtained by scanning a plaster model that reproduces the patient's oral cavity with a model scanner.

11. A method for manufacturing oral devices for treating obstructive sleep apnea, comprising: outputting three-dimensional data for a plurality of oral devices, each having a different position of the mandible relative to the upper jaw, obtained by the design method described in claims 1 to 10, and manufacturing the devices using a 3D printer.

12. A method for manufacturing an oral appliance for treating obstructive sleep apnea, comprising fitting a plurality of oral appliances for treating obstructive sleep apnea as set forth in claim 11 to a patient and determining an appropriate mandibular protrusion position.

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