A titanium plate for mandibular bridging reconstruction

Abstract

This application relates to a titanium plate for mandibular bridging reconstruction, belonging to the field of medical device technology. It includes a titanium plate body comprising an upper edge portion, a lower edge portion, and a connecting portion between the two. The upper edge portion forms an upper reinforcing rib extending along the length of the titanium plate, and the lower edge portion forms a lower reinforcing rib extending along the length of the titanium plate. The connecting portion forms a stress-dispersing zone connecting the upper and lower reinforcing ribs, and the thickness of the stress-dispersing zone is less than the thickness of the upper and lower reinforcing ribs. In the bridging section, the stress-dispersing zone is concave inward relative to the outer surfaces of the upper and lower reinforcing ribs, forming a soft tissue tension-reducing zone. In the bone-covering section, the upper and / or lower reinforcing ribs have a gradient structure with decreasing thickness along the direction away from the bridging section. The bone-covering section is provided with several retention holes for accommodating retention screws. This application's solution can improve the load-bearing stability of bridging reconstruction and reduce stress concentration, soft tissue tension, and the risk of titanium plate exposure.

Description

Technical Field

[0001] This application relates to a titanium plate for mandibular bridging reconstruction, belonging to the field of medical device technology. Background Technology

[0002] In the treatment of diseases such as tumor resection, severe osteomyelitis, or radiation-induced osteonecrosis, segmental resection of the mandible is often required, resulting in a large area of ​​bone continuity defect. In cases where free bone flap repair is not performed simultaneously or is temporarily unsuitable, bridging reconstruction with titanium plates is usually used clinically to maintain the shape, function, and occlusion of the mandible.

[0003] However, existing reconstructive titanium plates mostly employ a uniform thickness straight or pre-bent design. This traditional design has revealed significant biomechanical defects in long-term clinical application: 1) Stress shielding: The stiffness of a uniformly thick titanium plate is much greater than that of bone tissue, leading to abnormal stress transmission at the bone-plate interface. The bone ends lack physiological stress stimulation, resulting in disuse atrophy and ultimately screw loosening. 2) Stress concentration and fatigue fracture: In bridging areas without bone support, a single-thickness titanium plate subjected to repeated chewing alternating loads is highly susceptible to metal fatigue fracture at stress concentration points. 3) Soft tissue complications: To ensure strength, traditional titanium plates are often large and convex, generating continuous high tension on the covered thin soft tissues (especially post-radiotherapy skin), easily leading to plate exposure, infection, or even implantation failure.

[0004] Even with pre-bending or local thickness adjustment, existing bridging reconstruction titanium plates typically rely on overall homogeneous load-bearing, lacking zonal structural designs that address the tension path at the upper edge of the mandible, the pressure path at the lower edge, and the shear transmission characteristics of the intermediate connecting area. Furthermore, for clinical scenarios such as thin soft tissue coverage in the bridging area, post-radiotherapy scarring, and poor blood supply, existing titanium plates also lack synergistic structural solutions that balance load-bearing, tension reduction, and tissue communication.

[0005] Furthermore, the contour design of existing bridging reconstruction titanium plates often focuses on bony support and strength requirements, with insufficient consideration for the matching of soft tissue thickness in the bridging area, alveolar ridge buffer space, and submandibular soft tissue tension. This often results in excessively high upper edges or overly full central areas of the plate, increasing the risk of postoperative soft tissue compression, increased incision tension, and plate exposure. Especially in clinical settings employing digital personalized design and 3D printing, if the upper and lower edge curves of the titanium plate, the inward contour of the bridging area, the size of the through-hole, and the smooth transition of the edges are not comprehensively optimized during the design phase, it will be difficult to fully leverage the biomechanical and soft tissue adaptation advantages of integrated personalized titanium plates.

[0006] Therefore, developing a gradient structure titanium plate that can both conform to the stress transmission trajectory of the mandible and effectively reduce soft tissue tension is a technical problem that urgently needs to be solved in this field. Summary of the Invention

[0007] To address the aforementioned issues, a titanium plate for mandibular bridging reconstruction is provided. By incorporating upper and lower reinforcing ribs and a thin stress-dispersing zone into the titanium plate body, a dual-main-load-bearing structure is formed, which improves the overall load-bearing stability of the bridging area and reduces local stress concentration. Simultaneously, by incorporating an inwardly concave soft tissue tension-reducing zone in the bridging segment and a gradient structure with decreasing thickness in the bone-covering segment, the load transfer to the residual mandible is improved, reducing soft tissue tension and the risk of titanium plate exposure, thereby enhancing the long-term stability of mandibular bridging reconstruction.

[0008] This application provides a mandibular bridging reconstruction titanium plate, including a titanium plate body extending along the anatomical shape of the mandible. The titanium plate body includes an upper edge portion, a lower edge portion, and a connecting portion located between the two. The upper edge portion forms an upper reinforcing rib extending along the length direction of the titanium plate, and the lower edge portion forms a lower reinforcing rib extending along the length direction of the titanium plate. The connecting portion forms a stress dispersion zone connecting the upper and lower reinforcing ribs, and the thickness of the stress dispersion zone is less than the thickness of the upper and lower reinforcing ribs. The titanium plate body includes a bridging segment corresponding to a segmental defect of the mandible and spanning the defect gap, and bone covering segments located on both sides of the bridging segment for contact and fixation with the remaining mandible; in the bridging segment, the stress dispersion zone is recessed inward relative to the outer surfaces of the upper and lower reinforcing ribs to form a soft tissue tension-reducing zone; in the bone covering segments, the upper and / or lower reinforcing ribs have a gradient structure with decreasing thickness along the direction away from the bridging segment; the bone covering segments are provided with a plurality of retention holes for accommodating retention screws.

[0009] Optionally, the gradient structure includes a first thickness region, a second thickness region, and a third thickness region arranged sequentially along the direction away from the bridging segment; The thickness of the first thickness region is greater than the thickness of the second thickness region, and the thickness of the second thickness region is greater than the thickness of the third thickness region.

[0010] Optionally, the thickness of the first thickness region is 2.1 mm to 2.5 mm, the thickness of the second thickness region is 1.8 mm to 2.1 mm, and the thickness of the third thickness region is 1.5 mm to 1.8 mm.

[0011] Optionally, the concave depth of the soft tissue tension-reducing zone is 2.0 mm to 4.0 mm.

[0012] Optionally, the stress dispersion zone is contracted inward by more than 1 mm relative to the upper and lower reinforcing ribs.

[0013] Optionally, the stress dispersion zone is provided with several through holes penetrating the inner and outer surfaces of the titanium plate body.

[0014] Optionally, the through hole can be circular, oblong, or irregular in shape.

[0015] Optionally, the maximum diameter of the through hole at its location is 1 / 3 to 2 / 3 of the total width of the titanium plate at that location.

[0016] Optionally, the upper edge of the bridging segment is recessed downward by more than 5 mm relative to the top of the adjacent residual mandibular alveolar ridge.

[0017] Optionally, the center-to-center distance between adjacent retention holes is 7 mm to 9 mm.

[0018] Optionally, the overall outer contour of the titanium plate body, the extension trajectory of the upper reinforcing rib and the lower reinforcing rib are continuous smooth curves, and the curvature between the bone covering segment and the bridging segment is continuously transitioned.

[0019] Optionally, the edges of the through hole and the outer contour edges of the titanium plate body are rounded or chamfered.

[0020] Optionally, the titanium plate body is made of medical-grade titanium alloy.

[0021] Optionally, the titanium plate body is individually designed based on the patient's mandibular imaging data to match the anatomical shape of the patient's mandible.

[0022] Optionally, the titanium plate body is integrally formed using an additive manufacturing process.

[0023] Optionally, the retaining hole is used to accommodate a locking screw or a non-locking screw.

[0024] The beneficial effects of this application include, but are not limited to: 1. The mandibular bridging reconstruction titanium plate of this application forms a dual main load-bearing structure by setting upper and lower reinforcing ribs and a stress dispersion zone with a small thickness on the titanium plate body, which can improve the overall load-bearing stability of the bridging area and reduce the risk of local stress concentration.

[0025] 2. The mandibular bridging reconstruction titanium plate according to this application can improve the load transfer to the residual mandible by setting a gradient structure with decreasing thickness in the bone coverage segment, thereby reducing stress abrupt changes at the bone-plate interface and the risk of screw loosening.

[0026] 3. The mandibular bridging reconstruction titanium plate according to this application, by setting an inwardly concave soft tissue tension-reducing zone in the bridging segment, can provide space for the covering soft tissue while ensuring the load-bearing capacity of the bridging zone, thereby reducing soft tissue tension and the risk of postoperative titanium plate exposure.

[0027] 4. The mandibular bridging reconstruction titanium plate of this application, by setting through large holes in the stress dispersion area, can reduce the weight of the bridging segment, improve the tissue communication between the inner and outer sides of the bridging segment, and reduce the pressure of local material accumulation on soft tissue.

[0028] 5. The mandibular bridging reconstruction titanium plate according to this application, by designing the upper edge of the bridging segment to avoid downward movement, can retain more soft tissue buffer space for the alveolar ridge area, thereby reducing the stimulation of the bridging segment to the local soft tissue.

[0029] 6. The mandibular bridging reconstruction titanium plate of this application, by designing a continuous curve transition for the overall outer contour of the titanium plate, the extension trajectory of the reinforcing ribs and the regional connection, can reduce stress concentration caused by local structural abrupt changes and improve soft tissue compatibility after implantation. Attached Figure Description

[0030] The accompanying drawings, which are included to provide a further understanding of this application and form part of this application, illustrate exemplary embodiments and are used to explain this application, but do not constitute an undue limitation of this application. In the drawings: Figure 1 This is a schematic diagram illustrating the overall application state of the titanium plate implanted into the mandible according to an embodiment of this application. Figure 2 The titanium plate involved in the embodiments of this application; Figure 3 This is a schematic cross-sectional view of the titanium plate involved in the embodiments of this application in the bone coverage section (showing the gradient thickness); Figure 4 This is a schematic cross-sectional view of the titanium plate in the bridging section according to an embodiment of this application (showing the concave structure). Figure 5 This is a side view of the titanium plate structure involved in the embodiments of this application (showing the thickness variation trend).

[0031] List of components and reference numerals: 1-Titanium plate body; 11-Upper reinforcing rib; 12-Lower reinforcing rib; 14-Stress dispersion zone; 15-Soft tissue tension reduction zone; 16-Through-hole; 17-Fixing hole; 111 - First thickness zone; 112 - Second thickness zone; 113 - Third thickness zone. Detailed Implementation

[0032] To more clearly illustrate the overall concept of this application, a detailed explanation is provided below with reference to the accompanying drawings.

[0033] To better understand the above-mentioned objectives, features, and advantages of this application, the application will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that, unless otherwise specified, the embodiments and features described in these embodiments can be combined with each other.

[0034] Many specific details are set forth in the following description in order to provide a full understanding of this application. However, this application may also be implemented in other ways different from those described herein. Therefore, the scope of protection of this application is not limited to the specific embodiments disclosed below.

[0035] Furthermore, it should be understood in the description of this application that the terms "center," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this application 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 application.

[0036] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "a plurality of" means two or more, unless otherwise explicitly specified.

[0037] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection, an electrical connection, or a communication connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0038] In this application, unless otherwise expressly specified and limited, the "above" or "below" of the second feature can mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. In the description of this specification, references to terms such as "an embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of this application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described can be combined in any suitable manner in one or more embodiments or examples.

[0039] refer to Figures 1-5 The embodiments of this application disclose a mandibular bridging reconstruction titanium plate, including a titanium plate body 1 extending along the anatomical shape of the mandible. The titanium plate body 1 includes an upper edge portion, a lower edge portion, and a connecting portion located between the two. The upper edge portion forms an upper reinforcing rib 11 extending along the length direction of the titanium plate, and the lower edge portion forms a lower reinforcing rib 12 extending along the length direction of the titanium plate. The connecting portion forms a stress dispersion zone 14 connecting the upper reinforcing rib 11 and the lower reinforcing rib 12, and the thickness of the stress dispersion zone 14 is less than the thickness of the upper reinforcing rib 11 and the lower reinforcing rib 12. During mandibular bridging reconstruction, the bridging segment needs to withstand bending stress and alternating loads generated by mastication loads over a long period. In this embodiment, the upper reinforcing rib 11 is set to correspond to the tensile stress transmission path of the upper edge of the mandible, and the lower reinforcing rib 12 is set to correspond to the compressive stress transmission path of the lower edge of the mandible, thereby forming a double main load-bearing structure extending along the main stress transmission direction of the mandible; the stress dispersion zone 14 is used to connect the upper reinforcing rib 11 and the lower reinforcing rib 12, and to disperse the local stress and shear load between the upper and lower load-bearing structures of the bridging segment, so as to improve the overall load-bearing stability of the bridging segment and reduce the risk of local stress concentration.

[0040] The titanium plate body 1 includes a bridging segment corresponding to a segmental defect of the mandible and spanning the defect gap, and bone covering segments located on both sides of the bridging segment for contact and fixation with the remaining mandible; in the bridging segment, the stress dispersion zone 14 is recessed inward relative to the outer surface of the upper reinforcing rib 11 and the lower reinforcing rib 12 to form a soft tissue tension reduction zone 15; in the bone covering segment, the upper reinforcing rib 11 and / or the lower reinforcing rib 12 have a gradient structure with decreasing thickness in the direction away from the bridging segment; the bone covering segment is provided with a plurality of retention holes 17 for accommodating retention screws.

[0041] The bridging section is the area corresponding to the mandibular bone defect and spanning the defect gap. It is mainly used to maintain the bridging load between the remaining mandibular bones on both sides of the defect area. The bone covering section is the area located on both sides of the bridging section and in contact with and fixed to the remaining mandibular bones. It is mainly used to realize the load transfer and fixed connection between the titanium plate and the remaining mandibular bones.

[0042] In one implementation, the gradient structure includes a first thickness region 111, a second thickness region 112, and a third thickness region 113 arranged sequentially along the direction away from the bridging segment; The thickness of the first thickness region 111 is greater than the thickness of the second thickness region 112, and the thickness of the second thickness region 112 is greater than the thickness of the third thickness region 113.

[0043] The area near the bridging section bears a greater bridging load transfer function, so the thickness of the reinforcing ribs at the corresponding positions is relatively large. Along the direction away from the bridging section, as the load is gradually transferred to the residual mandible, the thickness of the reinforcing ribs gradually decreases, thereby gradually transitioning the stiffness of the titanium plate towards the residual mandible to reduce the risk of sudden stress changes in the bone-covered section and stress concentration around the screws.

[0044] In one implementation, the thickness of the first thickness region 111 is 2.1 mm to 2.5 mm, the thickness of the second thickness region 112 is 1.8 mm to 2.1 mm, and the thickness of the third thickness region 113 is 1.5 mm to 1.8 mm.

[0045] In some embodiments, the gradient structure may be a stepped thickness variation structure; in other embodiments, the gradient structure may be a continuous slope thickness variation structure to achieve a continuous transition in the thickness of the reinforcing ribs.

[0046] As one implementation method, the indentation depth of the soft tissue tension-reducing zone 15 is 2.0 mm to 4.0 mm. By setting the inwardly recessed soft tissue tension-reducing zone 15 in the bridging segment, additional clearance space can be provided for the soft tissue covered by the bridging segment while preserving the main load-bearing paths of the upper reinforcing rib 11 and the lower reinforcing rib 12, thereby reducing the local soft tissue tension in the bridging segment and the risk of postoperative titanium plate exposure.

[0047] In one implementation, the stress dispersion zone 14 is recessed inward by more than 1 mm relative to the upper reinforcing rib 11 and the lower reinforcing rib 12. This inward recess of the stress dispersion zone 14 reduces the outward bulge in the middle of the bridging section while ensuring the overall structural continuity of the bridging section, thereby reducing the pressure exerted by the bridging section on the surrounding soft tissue.

[0048] In one implementation, the stress dispersion zone 14 is provided with several through holes 16 penetrating the inner and outer surfaces of the titanium plate body 1. The through holes 16 are mainly provided in the stress dispersion zone 14 of the bridging section. By reducing the material accumulation in the middle area while retaining the main load-bearing structure of the upper reinforcing rib 11 and the lower reinforcing rib 12, the weight of the bridging section can be reduced, which is conducive to the exchange of tissues between the inner and outer sides of the bridging section.

[0049] In one embodiment, the through hole 16 is circular, oblong, or irregular in shape.

[0050] In one implementation, the maximum diameter of the through hole 16 at its location accounts for 1 / 3 to 2 / 3 of the total width of the titanium plate at that location. When the diameter of the through hole 16 is too small, the effect of weight reduction and traffic organization in the bridging section is limited; when the diameter of the through hole 16 is too large, it may weaken the overall structural continuity of the bridging section and increase the risk of local stress concentration.

[0051] As one implementation method, the upper edge of the bridging segment is recessed downwards by more than 5 mm relative to the top of the adjacent residual mandibular alveolar ridge. This recessed upper edge of the bridging segment preserves more soft tissue buffer space in the alveolar ridge area, thereby reducing the stimulation of the local soft tissue by the upper edge of the bridging segment.

[0052] In one implementation, the center-to-center distance between adjacent retention holes 17 is 7 mm to 9 mm. This ensures that the remaining mandible has a sufficient number of retention holes 17 while avoiding an overly dense arrangement of retention holes 17 that could lead to a decrease in the local structural strength of the bone covering segment.

[0053] In one implementation, the overall outer contour of the titanium plate body 1, the extension trajectory of the upper reinforcing rib 11 and the lower reinforcing rib 12 are continuous and smooth curves, and the curvature transitions continuously between the bone covering segment and the bridging segment. By designing a continuous curvature transition for the overall outer contour of the titanium plate body 1, the extension trajectory of the reinforcing ribs, and the regional connection points, stress concentration caused by abrupt changes in local structure can be reduced, and the soft tissue compatibility after titanium plate implantation can be improved.

[0054] As one implementation, the edge of the through hole 16 and the outer contour edge of the titanium plate body 1 are rounded or rounded.

[0055] As one implementation method, the titanium plate body 1 is made of medical-grade titanium alloy.

[0056] As one implementation method, the titanium plate body 1 is individually designed based on the patient's mandibular imaging data to match the anatomical shape of the patient's mandible.

[0057] In some implementations, a three-dimensional model of the mandible can be established based on the patient's CT image data, and the titanium plate body 1 can be individually designed in combination with the defect range to improve the matching degree between the titanium plate and the patient's mandibular anatomical structure.

[0058] In one implementation, the titanium plate body 1 is integrally formed using additive manufacturing. Additive manufacturing improves the forming accuracy of the complex curved surface structure and local gradient structure of the titanium plate body 1, thereby enhancing the fit between the titanium plate and the patient's mandibular shape.

[0059] In one implementation, the retaining hole 17 is used to accommodate a locking screw or a non-locking screw. This application is not a single thickness variation structure or a single opening structure, but rather a combination of a dual main load-bearing structure, a gradient thickness structure, a soft tissue tension reduction structure, and a through-hole 16 structure to reduce the risk of soft tissue tension and local stress concentration while ensuring the overall load-bearing stability of the bridging section.

[0060] The various embodiments in this specification are described in a progressive manner. Similar or identical parts between embodiments can be referred to interchangeably. Each embodiment focuses on describing the differences from other embodiments. In particular, the system embodiments are basically similar to the method embodiments, so the description is relatively simple; relevant parts can be referred to the descriptions in the method embodiments.

[0061] The above description is merely an embodiment of this application and is not intended to limit the scope of this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the scope of the claims of this application.

Claims

1. A titanium plate for mandibular bridging reconstruction, characterized in that, The invention includes a titanium plate body extending along the anatomical shape of the mandible, the titanium plate body comprising an upper edge portion, a lower edge portion, and a connecting portion located between the two; the upper edge portion forms an upper reinforcing rib extending along the length direction of the titanium plate, and the lower edge portion forms a lower reinforcing rib extending along the length direction of the titanium plate; the connecting portion forms a stress-dispersing zone connecting the upper reinforcing rib and the lower reinforcing rib, and the thickness of the stress-dispersing zone is less than the thickness of the upper reinforcing rib and the lower reinforcing rib. The titanium plate body includes a bridging segment corresponding to a segmental defect of the mandible and spanning the defect gap, and bone covering segments located on both sides of the bridging segment for contact and fixation with the remaining mandible; in the bridging segment, the stress dispersion area is recessed inward relative to the outer surfaces of the upper and lower reinforcing ribs to form a soft tissue tension reduction area. In the bone covering section, the upper and / or lower reinforcing ribs have a gradient structure with decreasing thickness along the direction away from the bridging section; the bone covering section is provided with a plurality of retention holes for accommodating retention screws.

2. The mandibular bridging reconstruction titanium plate according to claim 1, characterized in that, The gradient structure includes a first thickness region, a second thickness region, and a third thickness region arranged sequentially along the direction away from the bridging segment; The thickness of the first thickness region is greater than the thickness of the second thickness region, and the thickness of the second thickness region is greater than the thickness of the third thickness region.

3. The mandibular bridging reconstruction titanium plate according to claim 2, characterized in that, The thickness of the first thickness region is 2.1 mm to 2.5 mm, the thickness of the second thickness region is 1.8 mm to 2.1 mm, and the thickness of the third thickness region is 1.5 mm to 1.8 mm.

4. The mandibular bridging reconstruction titanium plate according to claim 1, characterized in that, The concave depth of the soft tissue tension-reducing zone is 2.0 mm to 4.0 mm.

5. The mandibular bridging reconstruction titanium plate according to claim 1, characterized in that, The stress dispersion zone is contracted inward by more than 1 mm relative to the upper and lower reinforcing ribs.

6. The mandibular bridging reconstruction titanium plate according to claim 1, characterized in that, The stress dispersion zone is provided with several through holes that penetrate the inner and outer sides of the titanium plate.

7. The mandibular bridging reconstruction titanium plate according to claim 6, characterized in that, The maximum diameter of the through hole at its location accounts for 1 / 3 to 2 / 3 of the total width of the titanium plate at that location.

8. The mandibular bridging reconstruction titanium plate according to claim 1, characterized in that, The upper edge of the bridging segment is offset downwards by more than 5 mm relative to the top of the adjacent residual mandibular alveolar ridge.

9. The mandibular bridging reconstruction titanium plate according to claim 1, characterized in that, The center-to-center distance between adjacent retention holes is 7 mm to 9 mm.

10. The mandibular bridging reconstruction titanium plate according to claim 1, characterized in that, The overall outer contour of the titanium plate body, the extension trajectory of the upper and lower reinforcing ribs are continuous and smooth curves, and the curvature between the bone covering segment and the bridging segment is continuously transitioned.

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