A light 3D preformed dense woven iodoform membrane, preparation method and application

Abstract

The application discloses a shallow 3D preformed dense woven iodoform film, a preparation method and application, and belongs to the technical field of medical oral cavity materials. The application solves the problems of iodoform yarn strip edge hair loss, loose fibers, easy to pull apart during suturing, poor planar fitting, insufficient intraoperative adaptability and the like. The application comprises a film main body, the film main body is preformed to form a shallow 3D preformed contour adapted to the surface of the alveolar ridge, the edge of the film main body is provided with an annular integrated self-locking edge structure, and the film main body is formed by weaving medical yarn filaments loaded with iodoform or is formed by weaving medical yarn filaments and then is treated by iodoform loading. While keeping the adsorption, bacteriostasis and local dressing functions of the traditional iodoform yarn strip, the application improves the problems of easy loose fibers, easy to pull apart and covering collapse of the traditional iodoform yarn strip through dense weaving, self-locking edge, suture reinforcement area and shallow 3D preformed contour.

Description

Technical Field

[0001] This invention belongs to the field of medical dental materials technology, specifically relating to a shallow 3D preformed densely woven iodoform membrane, its preparation method, and its application. Background Technology

[0002] Iodoform gauze has long been used for the treatment of oral and surgical wounds due to its local coverage, exudate absorption, and antibacterial properties. It is particularly useful in the local management of extraction wounds, alveolar sockets, and superficial contaminated wounds, where its ease of use and high clinical acceptance make it a popular choice.

[0003] The effective function of existing iodoform yarns comes not only from the yarn's own liquid absorption and covering properties, but also from the loading state of iodoform on the yarn surface, inside the fiber bundle, and between the yarn fibers. Therefore, for products that use "iodoform film" as their name and core function, the loading location, loading method, and fixation state of iodoform must be clearly defined in the structure and preparation process.

[0004] However, existing iodoform gauze strips are usually loosely striped or gauze-like structures, which have the following shortcomings when used as a surface covering material for oral wounds:

[0005] 1. The edges are prone to shedding, fraying, and loosening. Existing iodoform yarns tend to have loosened edge fibers after cutting, especially in humid environments or after being clamped or pulled by instruments, resulting in a significant decrease in edge integrity.

[0006] 2. During sewing, it is easy to cause tearing and enlarged holes. The overall structural stability of traditional loose yarn is insufficient. After the needle is punctured, local fibers are prone to displacement or breakage, resulting in enlarged needle holes, material tearing, or unstable fixation.

[0007] 3. Insufficient fit and shape retention of planar sheets. Ordinary iodoform gauze is more suitable for filling, but if used to cover alveolar sockets or gingival surfaces, it is prone to collapse, curling, stacking, or mismatch with the local alveolar ridge morphology.

[0008] 4. Limited clinical adaptability. Traditional iodoform gauze lacks a pre-made specification system for different wound sizes, such as single anterior teeth, single posterior teeth, multiple anterior teeth, and multiple posterior teeth. It often requires a lot of trimming during the operation, which not only increases the complexity of the operation, but also further leads to the problem of edge fiber breakage.

[0009] To address the aforementioned issues, while subsequent edge wrapping can improve the problem of edge detachment to some extent, it increases the preparation process and may lead to local thickening of the edges, which is not conducive to local adhesion in the oral cavity. Due to the aforementioned problems with current iodoform gauze, its application in oral wound coverage is not effective. For example, most tooth extraction sockets currently undergo open healing without any covering, which makes the wound recovery effect need to be improved. Summary of the Invention

[0010] To address the problems of edge hair loss, fiber loosening, easy tearing during suturing, poor planar adhesion, and insufficient intraoperative adaptability of iodoform gauze in existing technologies, this invention provides a shallow 3D preformed densely woven iodoform film, its preparation method, and its application.

[0011] The technical solution adopted in this invention is as follows:

[0012] A shallow 3D preformed densely woven iodoform membrane includes a membrane body, which is preformed to form a shallow 3D preformed contour that is adapted to the surface of the alveolar ridge. The edge of the membrane body is provided with an annular integral self-locking edge structure. The membrane body is woven from medical gauze loaded with iodoform, or is formed by weaving medical gauze and then loading it with iodoform.

[0013] After adopting this technical solution, the present invention uses an integrated self-locking edge structure formed during the weaving process, which can significantly reduce edge shedding, fiber shaving and thread breakage without additional edge binding. Compared with the subsequent edge binding solution, the present invention forms an anti-fragmentation edge through the weaving process itself, which is beneficial to reduce post-processing steps. At the same time, the membrane body has a shallow 3D pre-formed contour, which is easier to adapt to the slight undulation of the alveolar ridge or tooth extraction wound surface compared with flat sheet materials.

[0014] Preferably, the membrane body is a four-corner extending waist-cinching structure, which includes four corner extending areas and a main body area.

[0015] After adopting this technical solution, the four-corner extended waist-tight structure allows the membrane body to maintain a full coverage margin around the perimeter while preventing excessive accumulation in the middle, thus improving the convenience of local overlap and stitching.

[0016] Preferably, the sum of the areas of the four corner extension areas accounts for 5-10% of the total area.

[0017] Preferably, each of the corner extension areas, the junction of the corner extension area and the main body area, or the junction between the membrane body and the integrated self-locking edge structure is provided with a stitching reinforcement area.

[0018] Preferably, when the suture reinforcement area is located at each of the corner extension areas or at the junction of the corner extension area and the main body area, the area of ​​each suture reinforcement area accounts for 2%-5% of the total area.

[0019] With this technical solution, the suture reinforcement area is located at the corner extension area or at the junction of the corner extension area and the main body area, which is used to improve the tear resistance of the needle puncture area.

[0020] Preferably, the stitching reinforcement area is prepared by one or more of the following methods: denser weaving, double-layer weaving, thickening, or yarn back folding.

[0021] Preferably, when the seam reinforcement area is located at the junction between the membrane body and the integrated self-locking edge structure, the seam reinforcement area is arranged circumferentially around the membrane body.

[0022] Preferably, the shallow 3D preformed contour is one of shallow arc shape, shallow dome shape, or shallow saddle shape.

[0023] Preferably, the depth at the maximum depth of the shallow 3D preformed contour is 1-3 mm.

[0024] Preferably, the iodoform loading is 1% to 40% of the bulk mass of the membrane, more preferably 5% to 30%; or 0.5 to 50 mg / cm² per unit area, more preferably 2 to 20 mg / cm².

[0025] Preferably, the iodoform loading treatment includes impregnation, spraying, coating, adsorption, composite fixation, coating spinning, microparticle embedding, or a combination thereof. After iodoform loading, the dispersion medium can be removed by room temperature drying, low temperature drying, reduced pressure drying, light-protected drying, or a combination thereof, so that the iodoform is fixed in the membrane matrix.

[0026] Preferably, the iodoform yarn can be prepared using a pre-loading and post-weaving process, that is, the medical yarn is first placed in an iodoform dispersion system for loading treatment, and after drying, the iodoform yarn is obtained, and then the iodoform yarn is densely woven to form the membrane body; alternatively, it can be prepared using a pre-weaving and post-loading process, that is, the medical yarn is first woven to form the membrane body and an integrated self-locking edge structure, and then the woven membrane body is subjected to an overall iodoform loading treatment.

[0027] Preferably, the membrane body is formed by densely weaving iodoform yarn into a membrane structure, wherein the iodoform yarn is medical yarn loaded with iodoform, and the iodoform is disposed on the surface of the yarn, inside the yarn, between the yarn fibers and / or in the pores of the membrane body.

[0028] Preferably, the membrane body is a dense woven structure formed by plain weave, twill weave, satin weave, warp knitting, weft knitting, heddle weave, double-layer weave, or a combination thereof; the integrated self-locking edge structure is one or more of the following formed during the weaving process: self-forming edge, anti-fraying edge, edge densification zone, back-folding locking edge, heddle locking edge, and edge stable weaving zone.

[0029] Preferably, the membrane body includes various models.

[0030] As a preferred option, different types of shallow 3D preformed densely woven iodoform membranes include at least single anterior tooth type, single posterior tooth type, multiple anterior tooth type, multiple posterior tooth type, and flat universal type.

[0031] By adopting this technical solution, the problem of edge fiber breakage caused by extensive cutting during surgery can be reduced through the prefabrication of multi-specification product systems, and the efficiency of clinical operation can be improved.

[0032] Preferably, the thickness of the membrane body is 1-2 mm.

[0033] Preferably, the membrane body has a continuous porous structure to accommodate both wound surface coverage and the passage of local exudates.

[0034] Furthermore, the pore size of the continuous pore structure is in the hundreds of micrometers range, specifically 100-200 μm.

[0035] A method for preparing a shallow 3D preformed densely woven iodoform film includes the following steps:

[0036] S1: Medical yarn is woven into a membrane body using a dense weaving method, and an integrated self-locking edge structure is simultaneously formed around the periphery of the membrane body during the weaving process. The medical yarn is loaded with iodoform, or the membrane body is loaded with iodoform after weaving is completed.

[0037] S3: The membrane body is formed by mold pressing, heat setting, wet setting, tension difference setting, double-layer structure pre-forming or a combination thereof to form a 3D pre-formed contour that is adapted to the alveolar ridge surface, resulting in a shallow 3D pre-formed dense woven iodoform membrane.

[0038] Preferably, when using an immersion loading method, the membrane substrate is immersed in a dispersion, suspension, or coating solution containing iodoform, allowing iodoform to enter the yarn surface, fiber bundle gaps, and membrane substrate pores; after removal, it is dried at room temperature, under reduced pressure, or at low temperature, so that iodoform is fixed in the membrane substrate in the form of particles, crystals, or a coating.

[0039] Preferably, iodoform is loaded onto the surface of medical yarn, inside the yarn, between fibers and / or in the pores of the membrane body by one or more methods such as impregnation, spraying, coating, adsorption, composite fixation, coating spinning or microparticle embedding to obtain an iodoform loaded membrane.

[0040] Application of a shallow 3D preformed densely woven iodoform membrane in the preparation of medical materials for surface covering and suture fixation of oral wounds.

[0041] Preferably, medical materials for covering and suturing oral wounds are used for surface covering of extraction wounds, alveolar socket openings, gingival wounds, superficial oral mucosal wounds, or other superficial oral tissue defects.

[0042] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are:

[0043] 1. The present invention adopts an integrated self-locking edge structure formed during the weaving process, which can significantly reduce edge shedding, fiber scattering and thread breakage without additional edge binding. Compared with the subsequent edge binding solution, the present invention forms an anti-fragmentation edge through the weaving process itself, which is beneficial to reduce post-processing steps. At the same time, the membrane body has a shallow 3D pre-formed contour, which is easier to adapt to the slight undulation of the alveolar ridge or tooth extraction wound surface compared with flat sheet materials.

[0044] 2. The four-corner extended waist-cinching structure in this invention allows the membrane body to maintain a full coverage margin around the perimeter while preventing excessive stacking in the center, thus improving the convenience of local overlap and sewing.

[0045] 3. The suture reinforcement area described in this invention is located at the corner extension area or at the junction of the corner extension area and the main body area, and is used to improve the tear resistance of the needle puncture area.

[0046] 4. This invention can reduce the need for intraoperative trimming. By using a prefabricated multi-specification product system, the problem of edge fiber detachment caused by extensive intraoperative cutting can be reduced, and clinical operation efficiency can be improved.

[0047] 5. This invention clearly sets up an iodoform loading structure and an iodoform loading process, so that iodoform can be distributed and fixed on the surface of the yarn, the gaps between fibers and the pores of the membrane body, thereby improving the mechanical stability and adhesion of traditional yarn strips while retaining and strengthening the local dressing function of iodoform yarn strips. Attached Figure Description

[0048] Figure 1 This is a schematic diagram of the shallow 3D preformed densely woven iodoform membrane in this invention;

[0049] Figure 2 This is a partial enlarged view of the membrane body and the integrated self-locking edge structure at the connection of adjacent sides of the shallow 3D preformed densely woven iodoform membrane in this invention;

[0050] Figure 3 This is a partial enlarged view of the membrane body and the integrated self-locking edge structure on one side of the shallow 3D preformed densely woven iodoform membrane in this invention;

[0051] Figure 4 This is a partial cross-sectional view of the shallow 3D preformed densely woven iodoform film in this invention;

[0052] Figure 5 is a partially enlarged schematic diagram of iodoform loaded in medical gauze and membrane body in this invention;

[0053] Figure 6 This is a comparison diagram of various types of shallow 3D preformed densely woven iodoform films in this invention;

[0054] Figure 7This is a schematic diagram of the structure of the shallow 3D preformed densely woven iodoform film used in this invention.

[0055] Figure 8 This is a graph showing the statistical results of adjacent tooth sensitivity rates compared to traditional methods;

[0056] Figure 9 This is a graph showing the statistical results of the overall complication rate of the present invention compared with the traditional method;

[0057] Figure 10 This is a graph showing the statistical results of postoperative bleeding rate compared to traditional methods;

[0058] Figure 11 This is a graph showing the statistical results of postoperative infection rates compared to traditional methods;

[0059] Figure 12 This is a graph showing the statistical results of the incidence of Sjögren's syndrome compared with the traditional method.

[0060] Among them, 1-membrane body, 101-main body area, 102-corner extension area, 2-integral self-locking edge structure, 3-suture reinforcement area, 4-needle puncture point, 5-suture, 6-mesial adjacent tooth, 7-tooth extraction wound, 8-gingival soft tissue, 9-distal adjacent tooth, 10-iodoform, 11-medical gauze, 12-fiber gap, 13-membrane body pore. Detailed Implementation

[0061] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. The components of the embodiments of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of this application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely represents selected embodiments of this application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0062] In the description of the embodiments of this application, it should be noted that the terms "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product of the invention is in use. They are 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. In addition, the terms "first," "second," and "third," etc., are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0063] Example 1

[0064] A shallow 3D preformed densely woven iodoform membrane includes a membrane body 1 with a thickness of 1 mm. The membrane body 1 is made of medical yarn 11 as the substrate and is formed using a dense weaving process. During the weaving process, an integrated self-locking edge structure 2 is simultaneously formed around the periphery of the membrane body. Figure 5 As shown, iodoform 10 can be loaded onto the surface of medical yarn 11, the interior of medical yarn 11, the fiber gaps 12 and / or the pores 13 of the membrane body by means of impregnation, adsorption, coating, composite fixation, coating spinning or microparticle embedding. The iodoform 10 yarn can be prepared before weaving or the membrane body 1 can be loaded as a whole after weaving.

[0065] Specifically, the iodoform 10 loading described in this embodiment is not merely reflected in the product name, but exists as a component of the membrane body 1. Iodoform can be located on the outer surface of a single medical gauze filament 11, or it can enter the fiber gaps 12 inside the gauze filament 11, and further remain in the membrane body pores 13 formed after dense weaving, thereby forming a composite structure between iodoform particles or iodoform loading 10 and the membrane body 1.

[0066] In this embodiment, after the membrane body 1 and the integrated self-locking edge structure 2 are woven, iodoform 10 is loaded by impregnation. The membrane body 1 is pre-formed to form a shallow 3D pre-shaped contour that matches the surface of the alveolar ridge. The edge of the membrane body 1 is provided with an annular integrated self-locking edge structure 2. The specific process of loading iodoform 10 is as follows: the woven membrane body 1 is taken and placed in an iodoform dispersion system for overall impregnation loading, so that iodoform fully contacts and enters the surface of the medical yarn 11, the fiber gaps 12, and the pores 13 of the membrane body. After impregnation, the membrane body 1 is taken out and dried in the dark, so that iodoform particles or crystals are deposited and fixed in the membrane body 1. After this process, the resulting membrane body 1 retains the original integrated self-locking edge structure 2 and shallow 3D pre-shaped contour, and at the same time has a clear iodoform 10 loading structure. In this embodiment, the iodoform 10 loading amount is 30% of the mass of the membrane body 1.

[0067] In one embodiment, a secondary loading treatment can be performed after the membrane body 1 has been pre-formed in shallow 3D, so that iodoform 10 can be further deposited on the surface and local pores of the shallow 3D pre-formed contour to compensate for the local drug shedding that may occur during the pre-forming process.

[0068] In one embodiment, the medical yarn 11 can first be subjected to iodoform loading treatment to obtain iodoform yarn loaded with iodoform 10. Then, the iodoform yarn is used for dense weaving, forming a membrane body 1 and an integrated self-locking edge structure 2 during the weaving process. This method allows iodoform 10 to enter the interior of the yarn fiber bundle before weaving, which is beneficial to improving the uniformity of iodoform 10 loading.

[0069] In one embodiment, the membrane body 1, which has been woven and formed into an integral self-locking edge structure 2, is immersed in a dispersion or suspension containing iodoform for 1 to 30 minutes, so that iodoform 10 enters the surface of the medical yarn 11, the fiber gaps 12 and the pores 13 of the membrane body; then the membrane body 1 is taken out and dried at room temperature in the dark, at low temperature or under reduced pressure, so that iodoform 10 is fixed in the membrane body 1 in the form of fine particles, crystals or coating, to obtain the iodoform 10 loaded membrane body 1.

[0070] It should be noted that the membrane body 1 is a dense woven structure formed by plain weave, twill weave, satin weave, warp knitting, weft knitting, heddle weave, double-layer weave, or a combination thereof. Preferably, it is a high-density plain weave structure, a heddle-stabilized edge combined with a dense woven area of ​​the main body, or a dense woven structure with an edge densification zone. The integrated self-locking edge structure 2 is one or more of the following formed during the weaving process: self-forming edge, anti-fraying edge, edge densification zone, back-folding locking edge, heddle-locking edge, and edge stabilizing woven area. The specific structures of the membrane body 1 and the integrated self-locking edge structure 2 in this embodiment are as follows: Figure 2-4 As shown; Figure 5 As shown, iodoform particles or iodoform loading material 10 are distributed on the surface of medical gauze 11, in the fiber gaps 12, and in the membrane body pores 13; therefore, the membrane body 1 is both a densely woven support structure and an iodoform loading carrier. In this embodiment, the membrane body 1 is a four-corner extended waist-cinching structure, which includes four corner extension areas 102 and a main body area 101; that is, as shown... Figure 7 As shown, the upper and lower parts of the membrane body 1 are relatively widened, while the left, right and middle parts are narrowed inward, and the four corners form an extended coverage area.

[0071] In this embodiment, by placing the membrane body 1 on a preset mold for shallow 3D preforming, the membrane body 1 forms a shallow arc-shaped contour that conforms to the surface of the alveolar ridge of a single posterior tooth. In other embodiments, the membrane body 1 can also form a 3D preformed contour that conforms to the surface of the alveolar ridge through heat setting, wet setting, tension difference setting, double-layer structure preforming, or a combination thereof. After drying and setting, a single posterior tooth product is obtained. In this embodiment, the deepest point of the shallow arc-shaped contour is 3mm. Figure 7 As shown, the product obtained in this embodiment has stable edges and a slight three-dimensional curvature, making it suitable for covering the surface of a single posterior tooth extraction wound and for suturing and fixing.

[0072] Specific usage instructions are as follows: Figure 7 As shown, Figure 7 This is a schematic diagram showing the state of the wound after the removal of the lower right 6 tubes, with the application of a shallow 3D pre-formed densely woven iodoform membrane. Figure 7 It can be seen that the membrane body 1 covers the tooth extraction wound 7, and the distal adjacent tooth needle puncture point 4 is located in the four corner extension areas 102 respectively. The membrane body 1 is connected to the surrounding gingival soft tissue 8 by sutures 5.

[0073] Example 2

[0074] This embodiment is basically the same as Embodiment 1, except that: Figure 1 As shown, a reinforced stitching zone 3 is provided at the junction between the membrane body 1 and the integrated self-locking edge structure 2; the reinforced stitching zone 3 is prepared by one or more of the following methods: localized dense weaving, localized double-layer weaving, localized thickening, or localized yarn back folding, as shown in the figure. Figure 1 As shown, reinforcement is achieved through localized densification in this embodiment. During needle puncture, the needle puncture point 4 is located within or adjacent to the suture reinforcement area 3, thereby improving tear resistance and fixation stability.

[0075] Example 3

[0076] In one embodiment, such as Figure 6As shown, the membrane body 1 includes various models, and the dimensions of each model in this embodiment are shown in Table 1 below. The models can be distinguished by their overall size, corner extension length, waist reduction, membrane curvature, and pre-forming height difference to adapt to different oral wound surface coverage areas. Specifically, the membrane body 1 models include at least: single anterior tooth type, single posterior tooth type, multiple anterior tooth type, multiple posterior tooth type, and flat universal type. The models can be distinguished by their overall size, corner extension length, waist reduction, membrane curvature, and pre-forming height difference to adapt to different oral wound surface coverage areas. The product of Example 1 is a single posterior tooth type shallow 3D pre-formed densely woven iodoform membrane; the single anterior tooth type shallow 3D pre-formed densely woven iodoform membrane is formed using the same method as in Example 1 to create the membrane body 1 and the integrated self-locking edge structure 2, but the overall size is smaller than the single posterior tooth type, and the corner extension amplitude is reduced. After preforming, the resulting membrane is more suitable for covering the surface of a small wound in a single anterior tooth area. For multiple anterior teeth, the shallow 3D preformed densely woven iodoform membrane uses iodoform yarn to densely weave a membrane body 1 with a longer long axis, simultaneously forming an integrated self-locking edge structure 2. The membrane's planar contour remains a waist-shaped contour, but it is further extended along its long axis to accommodate continuous coverage of multiple adjacent anterior tooth wound areas. After preforming, it forms a shallow saddle-shaped or shallow arc-shaped contour. For multiple posterior teeth, the shallow 3D preformed densely woven iodoform membrane uses iodoform yarn to densely weave a membrane body 1 with a larger coverage area. The four corner extension areas are further lengthened, and multiple suture reinforcement areas 3 can be pre-set in the corner extension areas or around the periphery. Through mold pressing, a more obvious but still shallow 3D preformed contour is formed to meet the coverage needs of larger wounds or longer alveolar ridge surfaces in multiple posterior tooth areas. The flat, general-purpose, densely woven iodoform membrane uses iodoform yarn to form a membrane body 1 and an integrated self-locking edge structure 2. The membrane body 1 can be flat, without obvious 3D shaping, or only slightly curved. This type is used for covering irregular shallow wounds or for trimming special areas.

[0077] Table 1

[0078]

[0079] To demonstrate the effectiveness of this invention, the following statistics were also compiled on the sensitivity rate of adjacent teeth, the overall complication rate, the postoperative bleeding rate, the postoperative infection rate, and the dry socket rate when using the traditional method (open healing of the alveolar socket without any covering) and the method of this invention for oral wound surface covering and suturing fixation. The evaluation criteria for each evaluation indicator are shown in Table 2:

[0080] Table 2

[0081]

[0082] The study subjects are as follows:

[0083] (a) Inclusion criteria

[0084] (1) Age 18–60 years old, gender not limited.

[0085] (2) A single permanent molar is to be extracted, including the first molar, the second molar or the third molar.

[0086] (3) The subject’s overall condition was basically stable and he could tolerate routine outpatient tooth extraction procedures.

[0087] (4) Can understand the content of this study and sign the informed consent form.

[0088] (5) Able to complete postoperative follow-up, pain scoring and medication records.

[0089] (ii) Exclusion criteria

[0090] (1) The anterior teeth or premolars are to be extracted, or multiple teeth need to be extracted at the same time.

[0091] (2) The area to be extracted is accompanied by other destructive lesions such as jaw cysts, periapical cysts, tumors, etc.

[0092] (3) Simultaneously, bone grafting, site preservation, membrane covering, bone augmentation, or other procedures that alter wound healing may be required.

[0093] (4) Patients with pericoronitis, acute purulent inflammation, acute space infection, need for incision and drainage, or need systemic antibiotics before the operation in the area to be extracted.

[0094] (5) Uncontrolled diabetes (HbA1c ≥8.0% or fasting blood glucose ≥8.8 mmol / L).

[0095] (6) Myocardial infarction or stroke within the past 6 months, or blood pressure >160 / 110 mmHg at the time of medical visit.

[0096] (7) Severe liver and kidney dysfunction, long-term immunosuppression, severe coagulation dysfunction or hemorrhagic disease.

[0097] (8) Previous or current use of anti-bone resorption drugs or anti-angiogenic drugs; previous history of head and neck / jawbone radiotherapy.

[0098] (9) Systemic use of antibiotics or glucocorticoids within the past month.

[0099] (10) Allergic to iodoform, iodine preparations, chlorhexidine or gauze dressings.

[0100] (11) Heavy smokers (≥20 cigarettes per day) or those who cannot comply with the 72-hour smoking ban after surgery; dangerous alcohol consumption.

[0101] (12) Pregnancy or lactation; menstruation is recommended to postpone surgery and randomize.

[0102] (13) The researcher judges that the follow-up cannot be completed or there are other circumstances that make the study unsuitable.

[0103] (III) Exit and Elimination Criteria

[0104] (1) The participants voluntarily withdrew from the study.

[0105] (2) If a serious adverse event occurs during the follow-up, it is not advisable to continue participating in the study.

[0106] (3) Seriously violated the research protocol, such as failing to accept intervention as required or being unable to complete key follow-ups.

[0107] (4) Additional interventions are required during the study, which may affect the evaluators of the primary endpoint.

[0108] The specific statistical results are as follows: Figure 8-12 As shown, from Figure 8 and Figure 12 It can be seen that when using the shallow 3D preformed densely woven iodoform membrane of the present invention for oral wound surface coverage and suture fixation, the rates of adjacent tooth sensitivity, total complication rate, postoperative bleeding rate, postoperative infection rate, and Sjögren's syndrome are significantly reduced compared with the traditional method.

[0109] The embodiments described above merely illustrate specific implementation methods of this application, and while the descriptions are detailed and specific, they should not be construed as limiting the scope of protection of this application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the technical solution of this application, and these modifications and improvements all fall within the scope of protection of this application.

Claims

1. A shallow 3D preformed densely woven iodoform film, characterized in that: The membrane body (1) is formed by preforming a shallow 3D preformed contour that is adapted to the alveolar ridge surface. The edge of the membrane body (1) is provided with an annular integral self-locking edge structure (2). The membrane body (1) is woven from medical gauze (11) loaded with iodoform (10), or woven from medical gauze and then loaded with iodoform (10).

2. The shallow 3D preformed densely woven iodoform film according to claim 1, characterized in that: The membrane body (1) is a four-corner extended waist-cinching structure, which includes four corner extension areas (102) and a main body area (101).

3. The shallow 3D preformed densely woven iodoform film according to claim 2, characterized in that: Each of the aforementioned corner extension areas (102), the junction of the corner extension area (102) and the main body area (101), or the junction between the membrane body (1) and the integrated self-locking edge structure (2) is provided with a stitching reinforcement area (3).

4. The shallow 3D preformed densely woven iodoform film according to claim 3, characterized in that: The stitching reinforcement area (3) is prepared by one or more of the following methods: dense weaving, double-layer weaving, thickening, or yarn back folding.

5. The shallow 3D preformed densely woven iodoform film according to claim 3, characterized in that: When the suture reinforcement area (3) is located at the junction between the membrane body (1) and the integrated self-locking edge structure (2), the suture reinforcement area (3) is arranged in a ring around the membrane body (1).

6. The shallow 3D preformed densely woven iodoform film according to claim 2, characterized in that: The shallow 3D preformed contour is one of the following: shallow arc shape, shallow dome shape, or shallow saddle shape.

7. A shallow 3D preformed densely woven iodoform film according to any one of claims 1-6, characterized in that: The membrane body (1) is formed by densely weaving medical yarn (11) loaded with iodoform (10), with iodoform (10) disposed on the surface of the medical yarn (11), inside the medical yarn (11), in the fiber gaps (12) and / or in the pores (13) of the membrane body; the membrane body (1) is a densely woven structure formed by plain weave, twill weave, satin weave, warp knitting, weft knitting, heddle weave, double layer weave or a combination thereof; the integrated self-locking edge structure (2) is one or more of the following formed during the weaving process: self-forming edge, anti-fraying edge, edge densification zone, back fold locking edge, heddle locking edge, edge stabilizing weave zone; The iodoform (10) is combined with medical gauze (11) in the form of crystals, particles, microparticles, suspended solids or coatings, and is maintained in the membrane body (1) by adsorption of medical gauze (11), retention in fiber gaps, surface deposition, pore embedding and / or composite fixation. The loading of iodoform (10) is 1% to 40% of the mass of the membrane body (1), or 0.5 to 50 mg / cm² per unit area.

8. A shallow 3D preformed densely woven iodoform film according to any one of claims 1-6, characterized in that: The membrane body (1) includes various models.

9. A method for preparing a shallow 3D preformed densely woven iodoform film as described in any one of claims 1-8, characterized in that: Includes the following steps: S1: The medical yarn (11) is woven into a membrane body (1) by a dense weaving method, and an integrated self-locking edge structure (2) is formed simultaneously on the periphery of the membrane body (1) during the weaving process. The medical yarn (11) is loaded with iodoform, or the membrane body (1) is loaded with iodoform (10) after weaving. S3: The membrane body (1) is formed by mold pressing, heat setting, wet setting, tension difference setting, double-layer structure pre-formation or a combination thereof to form a 3D pre-formed contour that is compatible with the alveolar ridge surface, and a shallow 3D pre-formed dense woven iodoform membrane is obtained.

10. The use of the shallow 3D preformed densely woven iodoform membrane according to any one of claims 1-8 in the preparation of a medical material for surface covering and suture fixation of oral wounds.

Images