A method for making a digital prosthetic to repair a complete cleft palate

Abstract

The present application relates to a kind of methods for repairing maxillary complete cleft palate with dentition defect patient by planting cover technology and digital stopper combination, the anatomical information of patient oral cavity and maxillary bone is obtained by medical image three-dimensional reconstruction technology, individualized stopper that is adapted to the nasal cavity form of patient and retains airway space is constructed using computer aided design technology, and the rear edge closed structure suitable for complete cleft palate is established;Silicone rubber stopper and connecting body structure are prepared by additive manufacturing technology, and the retention and stability of denture are enhanced using implant and locator attachment, reliable connection between stopper and denture is realized, so as to improve the fitness, stability and comfort of prosthesis, improve the mastication, swallowing and speech function of patient, realize the oral function reconstruction of complex maxillary complete cleft palate with dentition defect patient.

Description

Technical Field

[0001] This invention relates to the fields of oral medicine and digital medical device technology, specifically to the fields of oral and maxillofacial restoration, implant restoration and digital-aided design and manufacturing technology, and more specifically to a method for restoring patients with maxillary cleft palate and missing teeth by combining implant overlay technology with digital occluders. Background Technology

[0002] Currently, for patients with maxillary cleft palate, especially edentulous patients, clinical restoration mainly employs techniques such as traditional tissue-supported occluders, complete dentures, and implant-supported overdentures. Traditional occluders can achieve closure of the oral and nasal cavities, improving patients' swallowing and speech functions. However, their retention and stability mainly rely on the support of remaining soft and hard tissues. For edentulous patients with severe alveolar ridge resorption and insufficient supporting tissue, problems such as loosening, dislocation, and decreased comfort of the restoration are prone to occur.

[0003] Furthermore, traditional occluders are mostly made using conventional molding and manual sculpting methods, and their shape design mainly relies on clinical experience, making it difficult to accurately adapt to the complex nasal cavity and soft palate anatomy of patients. For patients with defects in the posterior edge of the soft palate and indistinct Passavant's ridge, the position of the posterior edge of traditional occluders is difficult to determine, which can easily lead to problems such as insufficient closure, reflux during swallowing, and limited improvement in speech; if the posterior edge extends too far, it may affect breathing and wearing comfort.

[0004] Meanwhile, patients with complete cleft palate often have alveolar bone hypoplasia and limited remaining bone volume, which limits conventional implantation options due to anatomical constraints, making restoration of complex cases more difficult.

[0005] Analysis of the existing technologies revealed that their fundamental flaws lie in the fact that existing restoration methods mainly rely on experience-based fabrication and a single restoration model, lacking digital individualized design based on the patient's three-dimensional anatomy, and lacking a synergistic restoration mechanism between the occluder and the implant overdenture. As a result, it is difficult to balance the relationship between oral and nasal cavity closure, airway preservation, speech restoration, and restoration stability.

[0006] Therefore, it is necessary to provide a new restorative method to improve the overall restorative effect for patients with complex total cleft palate dentition defects. Summary of the Invention

[0007] The purpose of this invention is to provide a method that utilizes implant overlays and occluders, based on the concept of digital individual design and combined restoration, to organically combine digital occluder restoration technology with implant overlay denture technology, and to construct a combined restoration system that takes into account oral and nasal cavity closure, airway preservation and denture stability.

[0008] The objective of this invention is achieved as follows: a method for fabricating a digital prosthesis to repair a complete cleft palate, comprising the following steps:

[0009] CT analysis steps: CT scans are used to obtain three-dimensional anatomical information of the patient's maxilla, nasal cavity, soft palate defect area and upper respiratory tract. Three-dimensional reconstruction software is used to build an individualized digital model of the patient, thereby accurately assessing the patient's remaining bone volume and defect range.

[0010] Design steps for the occluder: Based on the patient's three-dimensional airway morphology information and soft palate defect information, construct a digital model of the occluder in computer-aided design software; by establishing a posterior closure structure, the occluder can improve velopharyngeal closure function, while reserving an appropriate airway gap according to the nasal cavity space, and making individualized adjustments to the posterior position based on the patient's age and tolerance, so as to improve pronunciation and swallowing function while taking into account airway patency and wearing comfort.

[0011] Design of the connector structure: A three-dimensional mechanical connection structure is designed between the oral surface of the occluder and the tissue surface of the removable denture. Two mushroom-shaped protrusions (diameter ≥ 8 mm) are used to establish a connector with the occluder. On the other side of the connection structure, a 1.5 mm thick curved surface is designed to conform to the tissue surface morphology of the denture.

[0012] Manufacturing steps for the plug: Based on the digital model of the plug formed in the previous step, design the digital female mold structure and the connector structure, import the three-dimensional data of the digital female mold and connector into the three-dimensional printing equipment to print the resin entity, and inject the prosthesis silicone rubber material in vitro to form the silicone rubber plug.

[0013] Implant design steps: Based on the remaining alveolar bone condition in the maxilla of the cleft palate patient, 1-2 implants are designed in each of the bilateral maxillae to provide retention and support for the final prosthesis. Implant surgery and restoration steps: The appropriate number of implants are inserted into the predetermined positions in the maxillae. After a period of time (e.g., 3 months) to achieve complete osseointegration of the implants, the Locator abutment is installed. An impression is taken while the patient is wearing a silicone rubber plug, and the removable denture is fabricated according to the traditional manufacturing process.

[0014] Connection Steps (Completed): After the patient has tried on the removable denture and it is perfected, the silicone rubber occluder is connected to the tissue surface of the removable denture through the corresponding 3D printed connector structure. The occluder assumes the function of sealing the oral and nasal cavities, while the denture assumes the function of chewing. The two work together to restore chewing function, improve swallowing, enhance speech function, and provide good wearing comfort.

[0015] Furthermore, in the manufacturing step of the occluder, a prosthetic silicone rubber material is used to prepare an elastic occluder with a Shore hardness of 35A, in order to improve the adaptability of the occluder to the surrounding tissues and the patient's comfort.

[0016] Furthermore, in the design of the obstruction device, the position and shape of the posterior edge of the obstruction device are designed along the posterior edge of the soft palate cleft using computer-aided design software. The digital model of the obstruction device is adapted to the patient's nasal cavity morphology while preserving airway space and not contacting the posterior airway wall (the location of the Passavant ridge). The space occupied by the obstruction device does not exceed 1 / 2 of the airway cross-sectional area, maintaining a minimum width of 8-10 mm for the remaining airway. The position of the posterior edge of the obstruction device is individually adjusted based on the patient's age and tolerance; for elderly patients, the posterior edge of the obstruction device terminates at the corresponding position behind the posterior edge of the soft palate cleft, without approaching the posterior pharyngeal wall, maintaining airway patency.

[0017] Furthermore, individualized implant design is carried out based on the patient's remaining alveolar bone condition. Implants are placed in areas with limited bone volume, and Locator attachments are installed after implant-osseointegration is completed. Stable support and retention are obtained through implant-supported overdentures.

[0018] The beneficial effects of this invention are as follows:

[0019] 1. Improved retention and stability of prostheses: This invention utilizes implants and locator attachments to provide auxiliary retention, compensating for the insufficient retention caused by severe alveolar ridge resorption and inadequate tissue support in edentulous patients with total cleft palate. A resin connector, designed and printed in 3D, achieves a reliable connection between the silicone rubber occluder and the removable denture, forming a cohesive structure that improves the stability of the prosthesis during chewing and speech, reducing loosening and dislocation.

[0020] 2. Improve the fitting accuracy between the occluder and the defect area: Based on CT images, this invention reconstructs the three-dimensional anatomical structure of the patient's upper respiratory tract, soft palate and remaining alveolar bone, and constructs an individualized occluder shape through computer-aided design, so that it can highly match the patient's defect area, reduce the edge misfit and local pressure caused by traditional experience-based manufacturing, and improve wearing comfort and restoration effect.

[0021] 3. Balancing oral and nasal cavity closure and airway patency: The invention designs the top structure of the occluder according to the patient's nasal cavity shape, making full use of the available soft tissue depressions in the patient's nasal cavity and reserving appropriate airway space. At the same time, it constructs a closure structure on the posterior edge of the soft palate for patients with total cleft palate. While improving oral and nasal cavity permeability, reducing swallowing reflux and improving speech function, it avoids the occluder having a significant impact on the airway and improves the patient's wearing tolerance.

[0022] 4. Improve the individualized restoration capability for patients with complex total cleft palate: This invention can perform individualized implant design and occluder design according to the patient's remaining alveolar bone condition and defect range, make full use of limited bone volume to complete implant placement, and adjust the position of the posterior edge of the occluder according to different degrees of soft palate defects, thereby improving the restorative adaptability under complex anatomical conditions and expanding the scope of restorative application.

[0023] 5. Achieving functional complementarity between occluders and implant-supported overdentures: Traditional occluders primarily function to seal the oral and nasal cavities, while implant-supported overdentures mainly provide retention and chewing support. This invention organically combines the two through a connecting structure, enabling the occluder and denture to work synergistically, simultaneously achieving oral and nasal cavity closure, restoration of chewing function, and improvement of speech function, thereby enhancing the overall restorative effect.

[0024] 6. Improved Precision and Repeat Manufacturing Capability of Restorations: This invention utilizes digital design and 3D printing technology to prepare the negative mold of the occluder and the connector, reducing reliance on operator experience during manual fabrication and improving the precision and consistency of restoration fabrication. When restorations age, become damaged, or require adjustment, they can be repeatedly manufactured using digital models, improving restoration efficiency.

[0025] 7. Improve patients' quality of life: By restoring the separation function of the oral and nasal cavities and enhancing denture retention, this invention can improve patients' chewing, swallowing and speech functions, reduce reflux and speech disorders, improve patients' comfort and social interaction ability, thereby improving patients' quality of life. Attached Figure Description

[0026] Figure 1 This is the core flowchart of the present invention.

[0027] Figure 2 This is a schematic diagram of the boundary position of the posterior edge of the soft palate constructed in reverse engineering software in this invention.

[0028] Figure 3 This is a diagram showing the top and rear morphology of the blocker.

[0029] Figure 4 It is a structural diagram of the female mold for designing the connector and silicone rubber plug.

[0030] Figure 5 This is a schematic diagram of a resin material connector and a blocking female mold manufactured by 3D printing.

[0031] Figure 6 This is a schematic diagram of a silicone rubber blocker.

[0032] Figure 7 This is a schematic diagram of two Straumann implants inserted into the patient's maxilla and connected to the Locator abutment.

[0033] Figure 8 This is a schematic diagram of the final form of the restoration. Detailed Implementation

[0034] The following will refer to the appendices in the embodiments of the present invention. Figure 1-8 The technical solutions in the embodiments of the present invention are clearly and completely described herein. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0035] like Figure 1-8 As shown, this paper presents a method for repairing maxillary cleft palate patients using a combination of implant overlay technology and digital occluder. It is not simply about improving the occluder or simply improving denture retention, but rather about combining digital occluder repair technology with implant overlay denture technology based on the concept of digital individual design and combined repair. This method constructs a combined repair system that takes into account the closure of the oral and nasal cavities, airway preservation, and denture stability.

[0036] This method is based on digital three-dimensional reconstruction, uses individualized silicone rubber occluders to achieve closure of the oral and nasal cavities and airway preservation, uses implant-supported overdentures to provide stable support and retention, and achieves synergistic effects of the two through connecting structures, thereby establishing a digital combined restoration method suitable for edentulous patients with complex total cleft palate.

[0037] First, CT scans are used to obtain three-dimensional anatomical information of the patient's maxilla, nasal cavity, soft palate defect area, and upper respiratory tract. Then, three-dimensional reconstruction software is used to create an individualized digital model of the patient, thereby accurately assessing the remaining bone volume and the extent of the defect.

[0038] Secondly, based on the three-dimensional morphology of the patient's airway and the characteristics of the soft palate defect, a digital model of the occluder was constructed in computer-aided design software. By establishing a posterior closure structure, the occluder can improve velopharyngeal closure function. At the same time, an appropriate airway gap is reserved according to the nasal cavity space, and the position of the posterior edge is individually adjusted according to the patient's age and tolerance, so as to improve pronunciation and swallowing function while taking into account airway patency and wearing comfort.

[0039] Furthermore, based on the digital model of the occluder, a 3D printing device is used to manufacture the occluder's female mold and connector, and a silicone rubber material is used to prepare an elastic occluder to improve the adaptability and comfort of the occluder to the surrounding tissues.

[0040] At the same time, individualized implant design is carried out based on the patient's remaining alveolar bone condition. Implants are placed in areas with limited bone volume, and Locator attachments are installed after the implants have integrated with the osseointegration. Stable support and retention are obtained through implant-supported overdentures.

[0041] Finally, the silicone rubber occluder is connected to the implant overdenture through a specially designed connection structure, so that the occluder can perform the function of sealing the oral and nasal cavities, and the denture can perform the function of chewing. The two work together to restore chewing function, improve swallowing, enhance speech function, and provide good wearing comfort.

[0042] A preferred embodiment is provided below:

[0043] Subjects: 65-year-old women with congenital complete cleft palate (complete cleft from hard palate to soft palate), edentulous maxilla, and thin alveolar ridge.

[0044] Implementation steps:

[0045] 1. CT analysis revealed that the remaining alveolar bone only had sufficient bone volume in the bilateral canine regions.

[0046] 2. Implantation design steps: Design the number and predetermined location of the implants, and prepare to implant two Straumann 3.3×10mm implants at the predetermined locations.

[0047] 3. Digital Blocker Design:

[0048] In reverse engineering software, the posterior edge of the occluder is designed along the two sides of the cleft of the soft palate.

[0049] Construct the top of the occluder, leaving a gap of about 5mm from the lower end of the nasal septum as an airway.

[0050] Age-appropriate adjustments: The posterior margin terminates 3 mm behind the posterior margin of the soft palate cleft, without approaching the posterior pharyngeal wall, and the remaining airway width is not less than 8-10 mm.

[0051] 4. Manufacturing: 3D printing of female mold and connector, fabrication of silicone rubber blocker, Shore hardness 35A.

[0052] 5. Surgery and restoration: The predetermined number of implants are placed in the predetermined positions, and the Locator abutment is installed 3 months later; after the patient wears the occluder, an impression is taken, and the complete denture is made according to the standard procedure.

[0053] 6. Completion: The complete denture and silicone rubber plug are connected by a 3D-printed connector to form an elastic mechanical connection.

[0054] Results: The patient's chewing function was restored, breathing was unobstructed, and there was no reflux during swallowing. Speech function improved compared to the traditional approach (the recovery was limited because the posterior edge of the occluder was not completely closed, but the patient tolerated it well).

[0055] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "front," and "rear," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention. In this invention, it should also be noted that the terms "installation" and "connection" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, an integrally formed connection, a mechanical connection, or an indirect connection through intermediate connecting parts. The specific meaning of the terms in this utility model can be understood according to the specific circumstances.

[0056] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered illustrative and non-limiting in all respects, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the present invention, and no reference numerals in the claims should be construed as limiting the scope of the claims.

[0057] Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. A method for fabricating a digital prosthesis to repair a complete cleft palate, characterized in that, Includes the following steps: CT analysis steps: Obtain three-dimensional anatomical information of the patient's maxilla, nasal cavity, soft palate defect area and upper respiratory tract through CT scan, and establish an individualized digital model of the patient using three-dimensional reconstruction software; Steps for designing an occluder: Based on the patient's three-dimensional airway morphology information and soft palate defect information, construct a digital model of the occluder in computer-aided design software; Manufacturing the blocker: Based on the digital model formed in the previous step, use 3D printing equipment to manufacture the silicone rubber blocker and connector; Implant design steps: Based on the remaining alveolar bone condition in the maxilla of the cleft palate patient, design 1 to 2 implants on each side of the maxilla to provide retention and support for the final prosthesis; Implant surgery and restoration steps: The appropriate number of implants are inserted into the predetermined positions in the maxilla. After sufficient implant healing time and complete osseointegration, the Locator abutment is installed. An impression is taken while the patient is wearing a silicone rubber plug, and a removable denture is fabricated. Connection steps: The silicone rubber plug is connected to the implant overdenture through the corresponding connection structure, so that the plug can perform the function of sealing the oral and nasal cavities, and the denture can perform the function of chewing.

2. The method for fabricating a digital prosthesis for repairing a complete cleft palate according to claim 1, characterized in that, In the process of manufacturing the blocker, a flexible blocker structure is prepared using silicone rubber material.

3. The method for fabricating a digital prosthesis for repairing a complete cleft palate according to claim 1, characterized in that, In the occluder design process, the posterior edge of the occluder is positioned along the two sides of the soft palate cleft in computer-aided design software to determine the coverage area of ​​the occluder.

4. The method for fabricating a digital prosthesis for repairing a complete cleft palate according to claim 1, characterized in that, In the design of the connection structure, two mushroom-shaped protrusions are used to establish a mechanical connection with the blocker. On the other side of the connection structure, a 1.5mm thick curved surface is designed to conform to the tissue surface morphology of the denture.

5. The method for fabricating a digital prosthesis for repairing a complete cleft palate according to claim 3, characterized in that, In the design of the occluder, the digital model of the occluder is adapted to the shape of the patient's nasal cavity and preserves the airway space without contacting the posterior wall of the airway; the space occupied by the occluder does not exceed 1 / 2 of the cross-sectional area of ​​the airway, and the narrowest width of the remaining airway is greater than 8~10mm.

6. The method for fabricating a digital prosthesis for repairing a complete cleft palate according to claim 5, characterized in that, In the process of designing the occluder, the position of the posterior edge of the occluder is individually adjusted based on the patient's age and tolerance.

7. The method for fabricating a digital prosthesis for repairing a complete cleft palate according to claim 2, characterized in that, The silicone rubber material used in the blocker has a Shore hardness of 35A.

8. A method for fabricating a digital prosthesis for repairing a complete cleft palate according to any one of claims 1-7, characterized in that, In the CT analysis step, a personalized digital model of the patient is reconstructed using 3D software, including a bone tissue model and a soft tissue model, to assess the patient's remaining bone mass and the extent of the defect.

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