A pre-shaped mesh fixation scaffold for oral soft tissue augmentation

Abstract

The application discloses a preformed mesh fixing support for oral soft tissue widening, relates to the technical field of oral implantation and repair, and comprises a mesh main body, an edge elastic memory support ring and a suture guiding ring. The mesh main body is made of degradable flexible material. The central part of the mesh main body is a central high-density compression area, and the periphery is a peripheral low-density decompression area. The mesh hole density of the central high-density compression area is higher than that of the peripheral low-density decompression area. The edge elastic memory support ring is arranged at the peripheral edge of the mesh main body, and the suture guiding ring is arranged at a specific position of the edge of the mesh main body and is used for guiding the suture to pass through to realize the fixation of the mesh main body. The application can solve the problems of instability of fixation, complexity of operation, poor area adhesion, easy curling and displacement of material, easy compression of edge blood supply, easy falling of the protection material of the upper palate supply area and the like when the existing soft tissue graft and replacement material mainly rely on traditional suture fixation.

Description

Technical Field

[0001] This invention relates to the field of oral implant restoration technology, specifically to a pre-formed mesh fixation frame for oral soft tissue widening surgery. Background Technology

[0002] With the development of dental implant restoration technology, the condition of the soft tissue around the implant has a significant impact on the long-term stability of the implant, patient comfort, and the outcome of the restoration. In clinical treatment, when the width of the keratinized gingiva around the implant is insufficient, the thickness of the soft tissue is insufficient, or the local soft tissue stability is poor, it is often necessary to widen the soft tissue and repair the wound through methods such as free gingival grafting (FGG), connective tissue grafting, decellularized dermal matrix, collagen matrix, or collagen sponge.

[0003] In current clinical practice, soft tissue grafts or substitutes are typically fixed with sutures. Traditional suturing methods connect the graft to the recipient tissue through several fixation points. However, the oral environment is complex, and the surgical area is easily affected by factors such as traction of the buccal and labial muscles, tongue movement, chewing stimulation, and saliva infiltration, leading to micromovement, curling, displacement, or edge lifting of the graft or substitute. For soft tissue substitutes such as acellular dermal matrix (ADM) and xenogeneic collagen matrix (XCM), their high softness and limited mechanical support make them more prone to problems such as poor adhesion, edge curling, central collapse, or dead space formation during and after surgery, thus affecting blood clot stability, vascular ingrowth, and soft tissue healing.

[0004] Traditional suturing methods require a high level of skill from the surgeon, especially when performing multi-point suturing in the confined space of the oral cavity. The procedure is time-consuming, and it's difficult to control suture tension evenly. If the suture is too loose, the graft material is prone to movement; if it's too tight, it may compress the blood supply to the graft margins, increasing the risk of marginal ischemia, necrosis, or delayed healing. For maxillary FGG donor sites, collagen sponge or similar hemostatic and protective materials are often placed after flap harvesting. However, current methods mostly rely on compression, simple suturing, or periodontal dressings for fixation, which presents problems such as easy dislodgement of hemostatic materials, insufficient wound protection, significant postoperative pain, and poor patient comfort. Summary of the Invention

[0005] To address the problems existing in the prior art, this invention provides a pre-formed mesh fixation frame for oral soft tissue widening surgery, which solves the problems of unstable fixation, complicated operation, poor recipient area fit, easy material curling and displacement, easy pressure on marginal blood supply, and easy dislodgement of palatal donor site protective material when existing soft tissue grafts and substitute materials are mainly fixed by traditional sutures.

[0006] The technical solution of the present invention is as follows: In a first aspect of the invention, a pre-formed mesh fixation frame for oral soft tissue widening surgery is provided, comprising a mesh body, an edge elastic memory support ring, and a suture guide ring; The mesh body is made of biodegradable flexible material and has a pre-formed curved surface shape that adapts to the oral anatomy. The center of the mesh body is a central high-density compression zone and the periphery is a peripheral low-density decompression zone. The mesh density of the central high-density compression zone is higher than that of the peripheral low-density decompression zone. The edge elastic memory support ring is disposed at the peripheral edge of the mesh body to maintain the unfolded shape and curvature of the mesh body; The suture guide ring is located at a specific position on the edge of the mesh body to guide the suture through so as to fix the mesh body.

[0007] In some embodiments of the present invention, the mesh body is a honeycomb, rhomboid, polygonal or woven mesh structure, and is made of a composite material of polydioxanone and medical collagen.

[0008] In some embodiments of the present invention, a micro-barb structure is provided at the position where the mesh body and the suture guide ring are connected.

[0009] In some embodiments of the present invention, the edge elastic memory support ring is a continuous ring structure or a segmented ring structure, and is made of poly-L-lactic acid material.

[0010] In some embodiments of the present invention, the suture guide ring is disposed at the four corners, two ends or the surrounding fixed area of ​​the mesh body, and is a blunt ear-shaped structure or an elliptical threading ring structure, and is made of a composite material of polydioxanone and medical collagen.

[0011] In some embodiments of the present invention, the suture guide ring is integrally formed with the mesh structure.

[0012] In some embodiments of the present invention, a pre-placed suture is provided inside the suture guide ring, and the pre-placed suture is an absorbable suture.

[0013] In some embodiments of the present invention, a drug sustained-release layer is also included, which is loaded on the surface or inside of the mesh body and contains chlorhexidine, minocycline, hyaluronic acid, growth factors or platelet-rich fibrin coating.

[0014] In some embodiments of the present invention, the mesh aperture of the mesh body is 0.5-2 mm.

[0015] In some embodiments of the present invention, the preformed curved surface shape includes alveolar ridge, palatal, anterior arc, posterior arc, crescent, or U-shape.

[0016] One or more technical solutions of the present invention have the following beneficial effects: (1) The present invention adopts a three-dimensional flexible mesh main body structure. The mesh main body adopts a partition structure that combines a central high-density compression area and a peripheral low-density decompression area. The central area can enhance the adhesion stability between the material and the recipient tissue, while the peripheral area can reduce excessive compression on the blood supply at the edge of the graft, thereby taking into account both fixation stability and tissue healing requirements, and solving the problem that uneven suture tension may lead to compression of the blood supply at the edge.

[0017] (2) The present invention can cover the surface of soft tissue grafts or substitute materials to form planar compression and uniform fixation. Compared with the traditional simple point suture method, it can reduce the risk of material micro-movement, curling and displacement after surgery. It can solve the problems of micro-movement, curling, lifting or displacement of materials such as ADM, XCM, FGG and collagen sponge in the oral activity environment, as well as the problem that the traditional point suture method is difficult to form uniform planar fixation.

[0018] (3) The present invention sets an elastic memory support ring at the edge of the mesh body, so that the mesh frame can automatically unfold and maintain a certain three-dimensional shape after placement, reducing the collapse, folding and curling of flexible materials, and can solve the problem of lack of support of flexible substitute materials, easy collapse or formation of dead space after surgery. It is especially suitable for the fixation of soft tissue substitute materials such as ADM and XCM.

[0019] (4) The blunt suture guide ring and pre-placed suture structure set in this invention allow doctors to quickly complete the fixation through the suture guide ring, avoiding the suture from directly passing through the mesh body and causing tearing. At the same time, it reduces the time spent finding the fixation point and repeatedly inserting needles during the operation, improves the operation efficiency, and can solve the problem of unstable fixation of hemostatic protective materials such as collagen sponge in the FGG donor area of ​​the palate.

[0020] (5) This invention can be pre-formed into arc-shaped structures according to different anatomical regions of the oral cavity, including alveolar ridge type, palatal type, anterior tooth arc type, and posterior tooth arc type, so that the fixation system fits the curved surface of the surgical area better, reduces intraoperative trimming and adjustment, and can solve the problem that existing fixation materials are difficult to adapt to the arc-shaped anatomical structures of the alveolar ridge, palate, and anterior and posterior tooth regions. The mesh body can be made of PDO, PLLA, PGA, PCL, collagen or their composite materials, and can be set as a biodegradable or partially biodegradable structure according to clinical needs, reducing patient discomfort caused by secondary removal after surgery.

[0021] (6) The present invention can be further provided with a drug sustained-release layer for loading chlorhexidine, minocycline, hyaluronic acid, growth factor, PRF coating or other healing-promoting active substances, which improves the antibacterial and healing environment of the surgical area while fixing the material. Attached Figure Description

[0022] Figure 1This is a front view of the preformed mesh fixing bracket of the present invention; Figure 2 This is a top view of the preformed mesh fixing bracket of the present invention; Figure 3 This is a side sectional view of the preformed mesh fixing bracket of the present invention; Figure 4 for Figure 1 A magnified view of a section at point A in the middle; Figure 5 This is a front view of the preformed mesh fixing bracket with pre-placed stitches of the present invention. Figure 6 This is a top view of the pre-formed mesh fixing bracket with pre-placed stitches of the present invention. Figure 7 This is a side sectional view of the preformed mesh fixing bracket with pre-placed stitches of the present invention. Figure 8 for Figure 5 A magnified view of a section at point B.

[0023] In the diagram: 1. Mesh main body; 101. Central high-density compression zone; 102. Peripheral low-density decompression zone; 2. Edge elastic memory support ring; 3. Suture guide ring; 4. Micro-barb structure; 5. Drug sustained-release layer; 6. Pre-placed suture. Detailed Implementation

[0024] It should be noted that the following detailed description is illustrative and intended to provide further explanation of the invention. Unless otherwise specified, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0025] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of exemplary embodiments according to the invention. As used herein, unless otherwise expressly indicated by the invention, the singular form is intended to include the plural form as well. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, devices, components, and / or combinations thereof.

[0026] Example 1 In a typical embodiment of the present invention, a pre-formed mesh fixation frame for oral soft tissue widening surgery is provided, such as... Figure 1 and Figure 5As shown, the device includes a mesh body 1, a central high-density compression zone 101, a peripheral low-density decompression zone 102, an edge elastic memory support ring 2, a suture guide ring 3, pre-placed sutures 6, and pre-shaped arc-shaped sutures. The mesh body 1 is used to cover ADM, XCM, FGG, collagen sponge, or other soft tissue repair materials; the edge elastic memory support ring 2 is used to maintain the unfolded state and predetermined three-dimensional shape of the mesh body 1; the suture guide ring 3 is set at the four corners, two ends, or peripheral fixed areas of the mesh body 1 to guide the sutures through; the pre-placed sutures 6 and pre-shaped arc-shaped sutures are used for rapid traction and fixation during the operation.

[0027] Specifically, such as Figure 2 and Figure 6 As shown, the central part of the mesh body 1 is a high-density compression zone 101, and the periphery is a low-density decompression zone 102. The mesh density of the central high-density compression zone 101 is higher than that of the periphery low-density decompression zone 102. The central high-density compression zone 101 is mainly used to form stable compression on the central part of materials such as ADM, XCM, FGG, or collagen sponge, so that the graft or replacement material is closely attached to the recipient tissue, reducing postoperative micromovement, curling, and displacement. The central high-density compression zone 101 is not a closed structure, but retains certain pores to facilitate the exchange of blood and tissue fluid and the ingrowth of new tissue. This ensures the fixation effect while avoiding complete blockage of the wound healing environment. The peripheral low-density decompression zone 102 is used to reduce excessive pressure on the soft tissue and graft edges by the mesh frame edge, avoiding the impact on edge blood supply due to overly tight fixation. At the same time, it provides space for soft tissue creep, blood vessel ingrowth, and tissue fluid exchange. The central high-density compression zone 101 and the peripheral low-density decompression zone 102 can form a continuous transition through gradual changes in pore size, or they can form clear zones through different mesh densities. This structure enables the pre-formed mesh fixation frame to simultaneously provide central stable fixation and edge decompression protection.

[0028] Furthermore, the mesh body 1 is made of biodegradable flexible material and has a pre-formed curved surface shape that adapts to the oral anatomy. Its shape can be set as alveolar ridge type, palatal type, anterior tooth arc type, posterior tooth arc type, crescent shape, or U-shape to adapt to different oral anatomical areas, thereby improving the fit between the mesh fixation frame and the surgical area surface and reducing problems such as edge lifting, folding, or uneven local tension when using flat mesh in curved areas. The mesh body 1 can be set to different sizes according to different clinical application scenarios. Its specifications can be set to small, medium, or large sizes according to the size of the surgical area, or to 5mm×5mm, 10mm×10mm, 15mm×20mm, 20mm×30mm, or other suitable sizes.

[0029] Preferably, the mesh body 1 is made of a composite material of polydioxanone (PDO) and medical collagen, used to cover ADM, XCM, FGG, collagen sponge, or other soft tissue repair materials. PDO provides flexibility, tensile strength, and absorbable support, while medical collagen improves the material's tissue compatibility and soft tissue adhesion. The mesh body 1 can be made into a honeycomb, rhomboid, polygonal, or woven mesh structure to adapt to the irregular shape of the oral soft tissue surface. The mesh body 1 is flexible, conforming to the alveolar ridge, hard palate, and peri-implant soft tissue surface; it also provides support, covering, limiting, and stabilizing the underlying FGG, ADM, XCM, or collagen sponge materials. The mesh size of the mesh body 1 is 0.5-2mm. Depending on the surgical area and fixation requirements, the mesh size can be set to 0.5mm×0.5mm, 1mm×1mm, 2mm×2mm or other suitable sizes. Smaller mesh sizes are used to enhance fixation, while larger mesh sizes are used to reduce pressure and facilitate tissue fluid exchange.

[0030] In this embodiment, the edge elastic memory support ring 2 is disposed at the peripheral edge of the mesh body 1 to maintain the unfolded shape and curvature of the mesh body 1, such as... Figure 3 and Figure 7 As shown. Preferably, the edge elastic memory support ring 2 is made of poly-L-lactic acid (PLLA). PLLA has good support performance, molding performance, and biodegradability, making it suitable as an edge support structure for a pre-formed mesh fixation frame. The edge elastic memory support ring 2 can automatically unfold after placement during surgery, allowing the mesh body 1 to maintain a predetermined arc or three-dimensional shape and better conform to the alveolar ridge, hard palate, or other arc-shaped soft tissue areas. The edge elastic memory support ring 2 can be a continuous ring structure or a segmented elastic support structure. For embodiments requiring stronger space maintenance capabilities, the edge elastic memory support ring 2 can also be made of nickel-titanium shape memory alloy; for fully absorbable embodiments, PLLA or PDO materials are preferred.

[0031] like Figure 4 and Figure 8As shown, in this embodiment, a suture guide ring 3 is also provided at a specific position on the edge of the mesh body 1 to guide the suture through for fixing the mesh body 1. Specifically, the suture guide ring 3 is provided at the four corners, both ends, or the surrounding fixing area of ​​the mesh body 1. A micro-barb structure 4 is provided at the connection position between the mesh body 1 and the suture guide ring 3. The micro-barb structure is used to increase the fixing effect at the edge. Preferably, the suture guide ring 3 is a blunt ear-shaped structure or an elliptical suture loop structure, and is integrally formed with the mesh body 1 or locally thickened and connected. The suture guide ring 3 is used to guide the suture through, enabling the doctor to fix the mesh fixation system to the periosteum, keratinized gingiva, adjacent soft tissue, or other stable tissue areas. The number of suture guide rings 3 can be set to 2, 4, 6, or more depending on the model. They are preferably set at the four corners and both sides of the long axis of the mesh body 1 for multi-point stable fixation.

[0032] Furthermore, during the manufacturing or preoperative preparation stage, polydioxanone absorbable sutures are pre-inserted or connected within the suture guide ring 3. This type of suture can be PDS II type polydioxanone absorbable sutures. Publicly available product information shows that PDS II sutures are composed of polydioxanone and are absorbable sutures with an absorption time range of 182–238 days; therefore, they are more suitable for use in oral soft tissue fixation scenarios requiring a certain period of time to maintain fixed strength.

[0033] In other embodiments, the pre-placed suture 6 may also be a polyethylene glycol-based or polyglactin 910 absorbable suture, such as VICRYL type suture, which, according to public information, is a polyglactin 910 absorbable suture with an absorption time range of 56-70 days. However, in the preferred embodiment of the present invention, the pre-placed suture 6 is preferably made of polydioxanone absorbable suture to obtain a longer period of fixation support.

[0034] In this embodiment, the pre-formed mesh fixation structure further includes a drug-releasing layer 5 to improve the healing microenvironment of the surgical area. The drug-releasing layer 5 is loaded on the surface or inside the mesh body 1 and contains chlorhexidine, minocycline, hyaluronic acid, growth factors, or a platelet-rich fibrin coating. The drug-releasing layer 5 may also employ other active substances with antibacterial, anti-inflammatory, hemostatic, or healing-promoting effects. The drug-releasing layer 5 is not a necessary structure of the present invention, but rather an enhancement of the implementation.

[0035] In use, the dentist selects a three-dimensional flexible mesh fixation frame of appropriate specifications and shape based on the location and area of ​​the surgical site and the type of fixation material required. For peri-implant soft tissue widening or periodontal soft tissue restoration recipient areas, FGG, ADM, XCM or other soft tissue grafts can be placed on the surface of the recipient area first, and then the present invention can be covered on the surface of the graft or replacement material, so that the central high-density compression area 101 corresponds to the central area of ​​the material, and the peripheral low-density decompression area 102 corresponds to the edge area of ​​the material.

[0036] After the three-dimensional flexible mesh fixation framework is placed, the PLLA marginal elastic memory support ring 2 causes the mesh body 1 to automatically unfold and conform to the alveolar ridge, hard palate, or other curved soft tissue surfaces. Subsequently, the dentist uses a rounded suture guide ring 3 and pre-placed polydioxanone absorbable sutures to fix the mesh fixation system to the periosteum, keratinized gingiva, adjacent soft tissue, or other stable tissue areas. Because the sutures are fixed through the suture guide ring 3, rather than directly through ordinary mesh openings, the risk of tearing of the mesh body 1 and loosening of fixation points is reduced.

[0037] After fixation, the central high-density compression zone 101 provides relatively stable planar compression to the graft or replacement material, reducing postoperative micromovement, curling, and displacement; the peripheral low-density decompression zone 102 reduces excessive marginal compression, preserving blood supply, tissue fluid exchange, and soft tissue creep space; the marginal elastic memory support ring 2 maintains the overall shape, preventing the mesh structure from collapsing or the material from folding. As the tissue heals, the PDO-collagen composite mesh body 1, the PLLA support structure, and the polydioxanone absorbable sutures can gradually degrade or be absorbed according to their respective material properties, thereby reducing the need for secondary removal.

[0038] For the FGG palatal donor site, this invention can cover the surface of collagen sponge or other hemostatic protective materials and fix it to the surrounding soft tissue through suture guide ring 3 and pre-placed sutures 6. At this time, the mesh body 1 can limit the displacement or dislodgement of collagen sponge, the edge elastic memory support ring 2 can maintain coverage stability, the central compression zone can provide moderate compression, and the peripheral decompression zone can reduce wound edge compression, thereby playing a role in assisting hemostasis, protecting the wound surface, reducing mechanical stimulation, and improving postoperative patient comfort.

[0039] The pre-formed mesh fixation frame provided in this embodiment is not simply a covering membrane or ordinary mesh, but a three-dimensional flexible fixation system for the stable fixation of oral soft tissue grafts and the maintenance of the healing microenvironment. It achieves stable fixation of soft tissue grafts, soft tissue substitutes, and wound protection materials through a combination of "flexible planar coverage, zoned pressure regulation, edge elastic support, suture-guided fixation, and pre-formed curved surface fitting."

[0040] Specifically, the pre-formed mesh fixation frame uses a three-dimensional flexible mesh body 1 to form a planar coverage and limit the material, reducing local tension concentration caused by traditional point suturing. The central high-density compression zone 101 enhances the adhesion stability between the central part of the material and the recipient tissue; the peripheral low-density decompression zone 102 reduces excessive compression in the marginal areas, promoting peripheral blood supply preservation and tissue healing; and the marginal elastic memory support ring 2 allows the mesh body 1 to automatically unfold and maintain a predetermined arc or three-dimensional shape after placement, thereby improving its adaptability to curved surgical areas such as the alveolar ridge, palate, and anterior and posterior teeth. With the suture guide ring 3 and pre-placed sutures 6, the surgeon can quickly complete positioning, traction, and fixation during the procedure, reducing repeated needle insertions and complex suturing steps, and improving operational efficiency. This invention can also be used for collagen sponge fixation and wound protection in the FGG palatal donor site, reducing displacement or detachment of hemostatic materials.

[0041] While the specific embodiments of the present invention have been described above in conjunction with the accompanying drawings, this is not intended to limit the scope of protection of the present invention. Those skilled in the art should understand that various modifications or variations that can be made by those skilled in the art without creative effort based on the technical solutions of the present invention are still within the scope of protection of the present invention.

Claims

1. A pre-formed mesh fixation frame for oral soft tissue widening surgery, characterized in that, Includes a mesh body, an edge elastic memory support ring, and a suture guide ring; The mesh body is made of biodegradable flexible material and has a pre-formed curved surface shape that adapts to the oral anatomy. The center of the mesh body is a central high-density compression zone and the periphery is a peripheral low-density decompression zone. The mesh density of the central high-density compression zone is higher than that of the peripheral low-density decompression zone. The edge elastic memory support ring is disposed at the peripheral edge of the mesh body to maintain the unfolded shape and curvature of the mesh body; The suture guide ring is located at a specific position on the edge of the mesh body to guide the suture through so as to fix the mesh body.

2. The pre-formed mesh fixation frame for oral soft tissue widening surgery as described in claim 1, characterized in that, The mesh body is a honeycomb, rhomboid, polygonal, or woven mesh structure, made of a composite material of polydioxanone and medical collagen.

3. The pre-formed mesh fixation frame for oral soft tissue widening surgery as described in claim 1, characterized in that, The mesh body and the seam guide ring are connected by a micro-barb structure.

4. The pre-formed mesh fixation frame for oral soft tissue widening surgery as described in claim 1, characterized in that, The edge elastic memory support ring is a continuous ring structure or a segmented ring structure, and is made of poly-L-lactic acid material.

5. The pre-formed mesh fixation frame for oral soft tissue widening surgery as described in claim 1, characterized in that, The suture guide rings are located at the four corners, both ends, or the surrounding fixed areas of the mesh body. They are rounded ear-shaped structures or elliptical threading ring structures, and are made of a composite material of polydioxanone and medical collagen.

6. The pre-formed mesh fixation frame for oral soft tissue widening surgery as described in claim 5, characterized in that, The suture guide ring is integrally formed with the mesh structure.

7. The pre-formed mesh fixation frame for oral soft tissue widening surgery as described in claim 1, characterized in that, A pre-placed suture is provided inside the suture guide ring, and the pre-placed suture is an absorbable suture.

8. The preformed mesh fixation frame for oral soft tissue widening surgery as described in claim 1, characterized in that, It also includes a drug sustained-release layer, which is loaded on the surface or inside of the mesh body and contains chlorhexidine, minocycline, hyaluronic acid, growth factors or platelet-rich fibrin coating.

9. The preformed mesh fixation frame for oral soft tissue widening surgery as described in claim 1, characterized in that, The mesh size of the main mesh body is 0.5-2mm.

10. The preformed mesh fixation frame for oral soft tissue widening surgery as described in claim 1, characterized in that, The preformed surface morphology includes alveolar ridge, palatal, anterior arc, posterior arc, crescent, or U-shape.

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