Method for manufacturing an orthopedic appliance comprising at least one functional joint guidance aligner, and aligner obtained

Abstract

The invention relates to a method for manufacturing an orthopedic appliance comprising at least one functional joint guidance aligner (1), which method consists in • Acquiring and recording first data relating to the dental molds (2) of the patient, • Acquiring and recording second data relating to a three-dimensional view of the skull (3) of the patient, • Combining the first and second recorded data, • Performing mandibular segmentation on the "combined" image, • Acquiring and recording a natural opening movement involving pure rotation, • Determining and recording a target position of the jaw of the patient, • Determining and recording occlusal guidance planes for temporomandibular joint repositioning, • Using the data relating to occlusal guidance planes for temporomandibular joint repositioning in order to design at least one maxillary and / or mandibular model (9) allowing the manufacture of at least one functional joint guidance aligner (1).

Description

Description Title: Method for manufacturing an orthopedic device comprising at least one functional joint guide splint, and splint obtained

[0001] [The present invention relates to a method for manufacturing an orthopedic device comprising at least one functional joint guide splint intended for use in the context of orthodontic treatment comprising a phase of anatomical joint placement that is as optimal as possible.

[0002] In summary, the present invention relates to the field of orthopedic devices intended for the treatment of disorders resulting from a dysfunction of the temporomandibular joint, which currently affects nearly 70% of the population, and which are frequently accompanied by pain and difficulty chewing.

[0003] More specifically, the aim of the present invention is to overcome the approximation problems of the solutions implemented at present, which are mainly based on steps of virtual simulation of arbitrary orthopedic sliding, or provide for the use of approximate empirical data which impair the effectiveness of the treatments carried out using the devices obtained.

[0004] To this end, the present invention relates to a method for manufacturing an orthopedic device comprising at least one functional joint guide splint, said method consisting of: - Acquire and record initial digital data relating to the patient's three-dimensional dental casts using an intraoral 3D camera, with the jaws in a natural position of maximum intercuspation (MIP), - Acquire and record second digital data relating to a three-dimensional view of the patient's skull using a 3D cone beam X-ray (cone beam computed tomography), with the jaws in a natural position of maximum intercuspation (MIP), - Combine the first and second recorded digital data to obtain a so-called "combined" image of the skull with the jaw in a natural position of maximum intercuspation (MIP), - Perform mandibular segmentation on the "combined" image of the patient's skull, - Simulate and record digital data relating to a natural opening movement (ORP) in pure rotation of the patient's jaw around its condylar axis, - Simulate and record digital data relating to a target position of joint repositioning of the patient's jaw, known as the "target orthopedic position (TOP)", - From the numerical data relating to a natural opening movement (ORP) in pure rotation of the patient's jaw around its condylar axis and the numerical data relating to the target orthopedic position (POC), determine and record, by means of a previously generated "digital rim", the numerical data relating to occlusal guidance planes for articulo-mandibular repositioning allowing the patient's jaw to be moved from its natural position of maximum intercuspation (MIP) with mandibular opening in rotation towards its target orthopedic position (POC), - To exploit the digital data relating to occlusal guidance planes for articulo-mandibular repositioning to design a maxillary and / or mandibular model allowing the manufacture of at least one functional joint guide splint integrating said occlusal guidance planes for articulo-mandibular repositioning.

[0005] Furthermore, the process according to the invention is also characterized in that it can comprise the following steps:

[0006] - To determine and record data relating to occlusal guidance plans for articulo-mandibular repositioning, enabling the patient's jaw to be moved from its natural position of maximum intercuspation (MIP) to its target orthopedic position (TOP), a preliminary step is performed in which digital data is acquired and recorded. relating to a simple mandibular rotation position (ORP), of the order of 1° to 3° of rotation around a condylar axis, preferably of the order of 1.5°,

[0007] - We determine and record the numerical data relating to the patient's Farrar diagram, and we determine and record the numerical data relating to the patient's modified Farrar diagram.

[0008] - At least one thermoformed or 3D-printed splint is designed, either total or partial, adapted to be worn removablely by the patient.

[0009] - At least one thermoformed or 3D-printed gutter is designed, adapted to allow the creation of shims or guide planes intended to be glued onto the patient's teeth,

[0010] - We determine and record the numerical data relating to occlusal guidance planes for articulo-mandibular repositioning in a segmented and / or fractional manner,

[0011] - We determine and record the numerical data relating to occlusal guidance plans for articulo-mandibular repositioning for the anterior sector only, or,

[0012] - We determine and record the numerical data relating to occlusal guidance plans for articulo-mandibular repositioning for the posterior sectors only, or

[0013] - We determine and record the numerical data relating to occlusal guidance plans for articulo-mandibular repositioning in a mixed manner, both for the anterior sector and for the posterior sectors.

[0014] The invention further relates to an orthopedic device comprising at least one functional joint guide splint obtained through the implementation of the process as previously described. The attached drawings illustrate the invention:

[0015] [Fig. 1] is a view of a digital dental cast of a patient obtained as part of the implementation of the method according to the invention, the jaw being in a natural position of maximum intercuspation (MIP),

[0016] [Fig. 2] corresponds to a three-dimensional digital view of a patient's skull obtained during the implementation of the method according to the invention,

[0017] [Fig. 3] illustrates a so-called "combined" digital image obtained after the step of combining the first and second recorded digital data, and in which the digital dental cast of figure 1 is superimposed on the skull, seen from the front, of figure 2,

[0018] [Fig. 4] illustrates the digital image obtained following the mandibular segmentation step in which the skull is viewed from the side, and the jaw placed in a natural position of maximum intercuspation (MIP),

[0019] [Fig. 5] represents the digital image obtained after a simulation of a simple rotation of approximately 1.5° of the mandible around the condylar axis (ORP), with the skull viewed from the side,

[0020] [Fig. 6] represents the digital image obtained after a simulation of a displacement of the mandible into its so-called "target orthopedic position" (TOP), with the skull viewed from the side,

[0021] [Fig. 7] represents a digital image obtained from a patient's skull in which the mandible is removed and a maxillary "digital rim", generated to determine the occlusal guidance planes for articulo-mandibular repositioning, is visible,

[0022] [Fig. 8] to [Fig. 17] are diagrams illustrating the steps involved in determining the occlusal guidance planes for articulo-mandibular repositioning,

[0023] [Fig. 18] represents a maxillary model resulting from the implementation of the process according to the invention, and

[0024] [Fig. 19] represents the model of figure 18 and the resulting guide gutter.

[0025] As indicated above, the present invention relates to a method of manufacturing an orthopedic device comprising at least one functional joint guide splint 1 (see fig. 19), intended to be used in the context of orthodontic treatment comprising an anatomical joint placement phase.

[0026] According to the invention, the first steps of the present method consist of acquiring and recording first digital data relating to the three-dimensional dental casts 2 of the patient (see Fig. 1) by means of an intraoral 3D camera, the jaws being in a natural position of maximum intercuspation (MIP), then acquiring and recording second digital data relating to a three-dimensional view of the patient's skull 3 (see Fig. 2) by means of a 3D cone beam X-ray (or cone beam tomography according to the French term), the jaws also being in a natural position of maximum intercuspation (MIP).

[0027] If appropriate, within the framework of this process, a step of determining and recording data relating to the patient's Farrar scheme, as well as data relating to the patient's modified Farrar scheme, can then be carried out.

[0028] A subsequent step involves combining the first and second recorded digital data in order to obtain a so-called "combined" image 4 of the skull with the jaw in a natural position of maximum intercuspation (MIP) (see Fig. 3), then performing a mandibular segmentation on the "combined" image of the patient's skull, in order to be able to simulate a displacement of the mandible 5 relative to the skull (see Fig. 4).

[0029] In accordance with an additional feature of the present method, it is then planned to simulate and record the numerical data relating to a natural opening movement (ORP) in pure rotation of the patient's jaw (see Fig. 5) as well as to simulate and record the numerical data relating to a position of the patient's jaw, called the "target orthopedic position" (POC) (see Fig. 6).

[0030] In this regard, it should be noted that in the illustrated example, this step of the process according to the invention consisted of simulating and recording the numerical data relating to a simple mandibular rotation position of approximately 1.5° (see Fig. 5), which allows the teeth to contact the splint and its guide planes before reaching maximum intercuspal occlusion. However, a rotation angle between 1° and 3° can also be considered for the same purpose.

[0031] Once the data mentioned above have been determined and recorded, the present procedure provides for a further step in which it is necessary to determine and record the numerical data relating to occlusal guidance planes for articulo-mandibular repositioning (see Fig. 8 to Fig. 17) allowing the patient's jaw to be moved from its natural position of maximum intercuspation (MIO) (see Fig. 8) to its target orthopedic position (COP).

[0032] According to the invention, a "digital rim" 6 (see Fig. 7) is used for this purpose, generated, for example, on the maxillary model as in the illustrated example, or, where applicable, on the mandibular model. Furthermore, such data relating to occlusal guidance planes for articulo-mandibular repositioning can advantageously be collected in a segmented and / or fractional manner.

[0033] In summary, depending on the case, the method according to the invention provides for the possibility of determining and recording digital data relating to occlusal guidance planes, articulo-mandibular repositioning from a pure rotational opening (ORP) to the target orthopedic position (POC) for the anterior sector only, or for the posterior sectors only, or even in a mixed manner for both the anterior and posterior sectors. In other words, the "digital rim" can also be partial, for example retro-incisal for the purpose of propulsion and centering, or lateral for the purpose of centering and slight propulsion.

[0034] Figures 8 to 17 schematically illustrate the steps in determining the guidance planes.

[0035] In figure 8, according to the method according to the invention, the mandible 5IM is placed in the position of maximum intercuspation occlusion (IMO).

[0036] Figure 9 illustrates the simulation, then, of a natural opening movement (ORP), in pure rotation of the order of 1.5°, of the mandible 5 around the condylar axis 7. We distinguish the mandible 5MIO placed in the position of maximum intercuspation (MIO), and the mandible 5ORP in its position after rotation.

[0037] Figures 10 and 11 illustrate the simulation of the movement of mandible 5 from the maximum intercuspal position (MIP) to the pure rotation opening position (PRO) and then to a target orthopedic position (TOP). The mandibular glide occurs between the pure rotation opening position (PRO) (1 er contact in closure) towards the target orthopedic position (POC) relative to the condylar axis 7 and the chosen guidance.

[0038] Figures 12 to 17 illustrate the implementation of a "digital rim" 6 generated on the maxilla 12 to determine and record digital data relating to occlusal guidance planes for articulo-mandibular repositioning to move the patient's jaw from its natural position of maximum intercuspation (MIP) to its target orthopedic position (COP).

[0039] In figure 12, according to the method according to the invention, the mandible 5 is moved to its natural opening position (ORP) and makes it possible to obtain on the "digital rim" 6 an indentation 8ORP of natural opening (see fig. 13) whose corresponding numerical data can be determined and recorded.

[0040] In figure 14, the mandible 5 is placed in its target orthopedic position (POC) and allows to obtain on the "digital rim" 6 a target orthopedic POC indentation (POC) whose corresponding numerical data can also be determined and recorded and adding to the natural opening indentation (ORP) 8 (cf. fig. 15).

[0041] Figures 16 and 17 illustrate the obtaining of the numerical data relating to occlusal guidance planes 11 for articulo-mandibular repositioning following a combination of the target orthopedic 8(POC) and natural opening 8(ORP) indentations, simulated on the digital rim 6. More specifically, Figure 16 illustrates the planes 11 to be obtained between the natural opening (ORP) and target orthopedic (POC) positions, while Figure 17 illustrates the occlusal guidance planes 11 for articulo-mandibular repositioning obtained.

[0042] In accordance with the method according to the invention, the numerical data relating to the occlusal guidance planes 11 for articulo- repositioning The mandibular data are then used to design a model 9, which is maxillary in the illustrated example (see Fig. 18) but can also be mandibular in other cases. Model 9 can, for example, be manufactured using 3D printing and will allow for the creation of at least one functional joint guide splint 1 incorporating occlusal guidance planes 11 for articulo-mandibular repositioning.

[0043] Such a splint 1 can be thermoformed, either full or partial, and manufactured using a sheet of plastic material adapted for thermoforming according to model 9. It can also be manufactured using a 3D printing process from a biocompatible material. It is intended to be worn, for example, removablely by the patient. The resulting splint 1 can, depending on the case, be used as is by the patient, but can also serve as a mold for manufacturing spacers or guide planes intended to be indirectly bonded to the patient's teeth, allowing simultaneous orthodontic treatment of the other teeth in the arch.

[0044] The advantages of the invention presented above are as follows:

[0045] - Such a method offers the possibility of recording a joint by cone beam computed tomography (CBCT) with an accuracy of 200-400 pm,

[0046] - This process allows orthodontics and prosthetics to place the bony bases (foundations) before any work is carried out on the dental arches, thus also enabling functional improvement.

[0047] - Unlike conventional orthodontics, this method allows for precise orthopedic joint management.

[0048] - Such a process provides a "test" system in case of diagnostic uncertainty for centering in orthodontics, but also in prosthetics and occlusodontics. - Insofar as the orthopedic device can be manufactured from biodegradable or recycled materials, the process according to the invention contributes to a reduction in plastic materials and consequently to the preservation of the environment.

Claims

Demands

1. [Method for manufacturing an orthopedic device comprising at least one functional joint guide splint (1) consisting of: - Acquire and record initial digital data relating to three-dimensional dental casts (2) of the patient using an intraoral 3D camera, with the jaws in a natural position of maximum intercuspation (MIP), - Acquire and record second digital data relating to a three-dimensional view of the patient's skull (3) using a 3D cone beam X-ray (cone beam computed tomography), with the jaws in a natural position of maximum intercuspation (MIP), - Combine the first and second recorded digital data in order to obtain a so-called "combined" image (4) of the skull with the jaw in a natural position of maximum intercuspation (MIP), - Perform a mandibular segmentation on the combined image (4) of the patient's skull (3), - Simulate and record digital data relating to a natural opening movement (ORP) in pure rotation of the patient's jaw around its condylar axis (7), - Determine and record the numerical data relating to a target occlusion position for joint replacement of the patient's jaw, known as the "target orthopedic position" (TOP), - From the numerical data relating to a natural opening movement (ORP) in pure rotation of the patient's jaw around its condylar axis (7) and the numerical data relating to the target orthopedic position (POC), determine and record, by means of a previously generated "digital rim" (6), the numerical data relating to occlusal guidance planes (11) for articulo-mandibular repositioning allowing the patient's jaw to be moved from its natural position of maximum intercuspation (MIP) and then with mandibular opening in rotation (ORP) to its target orthopedic position (POC), - Exploit the data relating to occlusal guidance planes for articulo-mandibular repositioning to design a maxillary (9) and / or mandibular model allowing the manufacture of at least one functional joint guide splint (1) integrating said occlusal guidance planes for articulo-mandibular repositioning.

2. A method according to claim 1, characterized in that in order to determine and record the numerical data relating to occlusal guidance planes for articulo-mandibular repositioning allowing the patient's jaw to be moved from its natural position of maximum intercuspation (MIO) to its target orthopedic position (TOP), a step is carried out beforehand in which the numerical data relating to a simple mandibular rotation position (MRO) are acquired and recorded, of the order of 1° to 3° of rotation around a condylar axis (7), preferably of the order of 1.5°.

3. A method according to any one of the preceding claims, characterized in that it comprises a step in which the numerical data relating to the patient's Farrar diagram are determined and recorded, and the numerical data relating to the patient's modified Farrar diagram are determined and recorded,

4. A method according to any one of the preceding claims, characterized in that at least one gutter (1) of thermoformed or 3D-printed type, total or partial, is designed to be worn removablely by the patient.

5. A method according to any one of claims 1 to 3, characterized in that at least one thermoformed or 3D-printed type tray is designed, adapted to allow the obtaining of shims or guide planes intended to be indirectly glued onto the patient's teeth.

6. A method according to any one of the preceding claims, characterized in that digital data relating to occlusal guidance planes (11) for articulo-mandibular repositioning are determined and recorded in a segmented and / or fractional manner.

7. Method according to the preceding claim, characterized in that it determines and records the numerical data relating to occlusal guidance planes for articulo-mandibular repositioning for the anterior sector only.

8. Method according to claim 6, characterized in that it determines and records the digital data relating to occlusal guidance planes for articulo-mandibular repositioning for the posterior sectors only.

9. Method according to claim 6, characterized in that the digital data relating to occlusal guidance planes for articulo-mandibular repositioning are determined and recorded in a mixed manner for both the anterior and posterior sectors.

10. Orthopedic device comprising at least one functional joint guide splint (1) obtained through implementation of the method according to any one of the preceding claims.

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