Plug treatment device with multiple layers of porous channels and preparation method of plug treatment device

Abstract

The invention relates to the technical field of medical instruments, and discloses a plugging treatment device with multiple layers of porous channels and a preparation method of the plugging treatment device. When the opening degree of the mouth is in a preset size, an impression material is placed at the cyst stoma, and the impression material is pressed at the opening of the cyst stoma and a connecting channel of the cyst stoma and a cyst cavity with preset pressure to obtain a first impression of the cyst stoma; and preparing a second impression of the cyst stoma and the affected side dentition by using an alginate material at the cyst stoma. Close combination of the plugging treatment device and the cyst stoma is achieved, and the situation that food residues enter a cyst cavity to cause infection after the plugging treatment device is too small or the situation that a patient pains, feels uncomfortable and is difficult to be in place due to the too large plugging treatment device is avoided. The prepared plugging treatment device is provided with multiple layers of porous channels, cyst fluid can be automatically discharged from the channels through the capillary action, and the cyst cavity can be flushed according to needs to jointly promote recovery of the cyst cavity.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a plug with multi-layer porous channels and a preparation method thereof. Background Art

[0002] When treating large jaw cysts, such as childhood odontogenic keratocysts and dentigerous cysts, cyst fenestration is often performed as a first-line option before cystectomy. After cyst fenestration, a decompression device that allows long-term drainage is used. In addition, the device should be stable and easy for the patient to perform daily irrigation and oral care on their own, and easy to remove during long-term follow-up. Typically, drainage tubes, strips, or gauze are sutured to the surrounding soft tissue; however, these drainage devices are foreign body sensations that can cause discomfort, are prone to food accumulation, and do not maintain space for future dentures in the absence of teeth.

[0003] Based on the above problems, currently, after cystic fenestration and decompression surgery, a plug is used to help temporarily close the wound, prevent the cyst stoma from healing prematurely, and ensure that the fluid in the cystic cavity can be continuously discharged. Wearing a plug can effectively promote the recovery of oral cysts, avoid the occurrence of postoperative complications, and provide strong protection for the patient's oral health. The current plug is prepared by using an oral scanner to collect the size and shape of the cyst stoma in the oral cavity. However, due to the optical impression principle of the oral scanner, it is impossible to directly collect mucosal data, resulting in poor compatibility between the prepared plug and the edge of the cyst stoma, affecting the self-healing of the cyst.

[0004] Therefore, there is an urgent need for a plug with multi-layer porous channels and a preparation method thereof, so that the plug can be well sealed with the cyst stoma and has high wearing comfort. Summary of the invention

[0005] In order to solve the above technical problems, the present invention provides a method for preparing a plug having multiple layers of porous channels, the preparation method comprising the following steps: The morphology of the cyst cavity is obtained by scanning the patient's jaw hard tissue data in the open state through CT; Use a digital scanner to perform intraoral scanning to obtain the patient's first dentition information and occlusal relationship; Control the patient's mouth opening degree to a preset size; when the mouth is opened to the preset size, the shape of the cyst stoma is consistent with the shape of the patient's closed mouth; At a preset size, placing an impression material in the cyst stoma, and pressing the impression material at the opening of the cyst stoma and the connecting channel with the cystic cavity with a preset pressure to obtain a first impression of the cyst stoma; At the cyst stoma, alginate material is used to make a second impression of the cyst stoma and the affected side dentition through a mortise and tenon structure based on the first impression of the cyst stoma; Based on the second impression, obtaining a third impression of the cyst stoma and the affected dentition by digital scanning; Acquire the second dentition information of the affected-side dentition in the oral cavity by digitally scanning the third impression; According to the first dentition information, the occlusal relationship, the second dentition information and the morphology of the cyst cavity, a 3D model of the cyst cavity-stoma-dentition-occlusal relationship is obtained by a fitting algorithm; A plug with multiple layers of porous channels is prepared based on the 3D model of the cyst cavity-stoma-dentition-occlusion relationship.

[0006] Furthermore, the A-type silicone rubber impression material.

[0007] Furthermore, the 3D model of the cavity-stoma-dentition-occlusion relationship is obtained by a fitting algorithm based on the first dentition information, the occlusal relationship, the second dentition information and the morphology of the cavity, specifically including: The morphological outline of the cyst stoma is used to design an anatomical crown, and the edge line of the anatomical crown is drawn; The adjacent teeth of the cystostomy are used as inlays, and the edge line of the inlay is drawn; According to the first dentition information, the occlusal relationship, the second dentition information and the morphology of the cavity, the overlapping areas of the dentition are matched, and then a fitting algorithm is performed to obtain an initial 3D model of the cavity-stoma-dentition-occlusal relationship; Determine the length of the plug extending into the cystic cavity according to the morphology of the cystic cavity; The 3D model of the cavity-stoma-dentition-occlusal relationship is determined based on the height of the plug, the angle of penetration into the cavity, the edge line of the anatomical crown, the edge line of the inlay and the initial 3D model.

[0008] Furthermore, after determining the length of the plug extending into the cystic cavity according to the shape of the cystic cavity, the method further includes: The number and diameter of the flushing and drainage holes in the plug are determined according to the diameter and outline of the cyst stoma, the depth of the cyst cavity, and the severity of the cyst. Each of the flushing and drainage holes extends toward the cystic cavity, and the number of channels, number of layers and aperture of the backflow holes in the plug are determined according to the number of flushing and drainage holes, the depth of the cystic cavity and the severity of the cyst.

[0009] Furthermore, the number of the flushing and drainage holes is 3.

[0010] Furthermore, the number of layers of the backflow holes is 3, which are located at the bottom of the capsule cavity, 1 / 3 and 2 / 3 of the depth of the capsule cavity respectively; A backflow hole is provided on the contact surface between each channel and the cyst cavity.

[0011] Furthermore, according to the shape of the cystic cavity, the length of the plug extending into the cystic cavity is determined by taking the depth of the cystic cavity as the length of the plug extending into the cystic cavity.

[0012] Furthermore, the 3D model of the cyst cavity-stoma-dentition-occlusion relationship is used to prepare a plug with multiple layers of porous channels. Specifically, a 3D printer is used to print the 3D model of the cyst cavity-stoma-dentition-occlusion relationship to complete the preparation of the plug with multiple layers of porous channels.

[0013] Furthermore, the printing material is a soft jaw pad resin material.

[0014] Another aspect of the present invention provides a plug having multiple layers of porous channels, which is obtained by using any of the above-mentioned preparation methods, and the plug comprises a plug body, a fixing part, and a bite part; The occlusal part connects the plug body and the fixing part and is made of elastic material; the contact surface with the oral cavity is provided with multiple flushing and drainage holes; The plug body is used to support the cyst stoma and penetrate into the cyst cavity, and is made of elastic material; each of the flushing and drainage holes extends toward the cyst cavity, and a multi-layer channel is provided in the part of the plug body that penetrates into the cyst cavity; The fixing part is inserted into the undercut area of ​​the affected-side dentition to connect the occlusal part and the affected-side dentition.

[0015] The embodiments of the present invention have the following technical effects: 1. The present invention provides a method for preparing a plug with multi-layer porous channels. When the patient's mouth is opened to a preset degree, the shape of the cyst stoma is molded. In this state, the cyst stoma does not deform, thereby ensuring the preparation accuracy of the plug.

[0016] 2. The present invention places an impression material at the cyst stoma when the size is preset, and presses the impression material at the opening of the cyst stoma and the connection channel with the cystic cavity with a preset pressure to obtain a first impression of the cyst stoma; at the cyst stoma, an alginate material is used to make a second impression of the cyst stoma and the affected dentition. In this way, the morphology of the cyst stoma and the connection channel between the stoma and the cystic cavity can be accurately obtained, avoiding the use of an oral scanner to collect the size, shape, etc. of the cystic cavity stoma in the oral cavity. The plug is tightly combined with the cyst stoma, and the edge fit is better, so that food residues cannot enter the cystic cavity to cause infection if the plug is too small, or the plug is too large to cause discomfort to the patient.

[0017] 3. The plug prepared in the present application has multiple layers of porous channels, and the cystic fluid can be discharged from the channels by capillary action. The cystic cavity can also be flushed as needed, thereby promoting the recovery of the cystic cavity. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0019] Figure 1 A flowchart of the steps of a method for preparing a plug having multiple layers of porous channels provided in an embodiment of the present invention; Figure 2 Provided for the embodiment of the present invention is a schematic diagram of second dentition information preparation; Figure 3 A schematic diagram of a plug structure having multiple layers of porous channels prepared in an embodiment of the present invention; Figure 4 A schematic diagram of creating a new project using CAD software and marking anatomical crowns, inlays, and opposing teeth in an embodiment of the present invention; Figure 5 A schematic diagram of an initial 3D model of the cyst-stoma-dentition-occlusion relationship in an embodiment of the present invention; Figure 6 A schematic diagram of flushing drainage holes in an embodiment of the present invention; Figure 7 Schematic diagram of the channel of the backflow hole in an embodiment of the present invention; Figure 8 This is a schematic diagram of the process of preparing a plug in an embodiment of the present invention; Fig. 9 Schematic cross-sectional view of the plug prepared in an embodiment of the present invention. DETAILED DESCRIPTION

[0020] In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work belong to the scope of protection of the present invention.

[0021] When CT rays penetrate different tissues of the human body, they will be absorbed by the tissues and attenuated. Different tissues have different degrees of absorption of X-rays due to their differences in density, thickness and atomic number. The surface of the bone tissue in the window area is covered with gingival soft tissue, which has low density and is difficult to develop in CT. Therefore, it is impossible to obtain stoma data through CBCT data. Stoma data can only be obtained through impression data. However, there is a large error in the data acquisition of movable soft tissues by oral scanning impressions. Due to the size limitation of the oral scanning instrument, the shape of the window opening is not accurately acquired. Even if the mouth is opened to obtain the shape of the opening, the deformation of the mouth will cause inaccurate results. Figure 8 FIG. 1 is a schematic diagram of an oral vestibule cyst in an embodiment of the present invention, which is more difficult to obtain. Therefore, obtaining stoma data is a key point in the production of this type of restoration.

[0022] In order to solve the above technical problems, the present invention provides a method for preparing a plug having multiple layers of porous channels. Figure 8 Schematic diagram of the process of preparing a plug in an embodiment of the present invention.

[0023] The specific steps of the preparation method are as follows Figure 1 As shown: S1: Obtain the morphology of the cystic cavity by scanning the patient's jaw hard tissue data in the open state through CT scanning; About 1 week after the window was opened for decompression, the iodoform gauze in the decompression window was removed and the size of the soft tissue defect was checked. Cone beam computed tomography (CBCT; NewTom VGi evo; Cefla) was used to obtain a 3D image of the open jaw cyst and the CBCT image was exported as a digital imaging and communications in medicine (DICOM) file to obtain the morphology of the cyst cavity, including the depth and size of the cyst cavity.

[0024] S2: Use a digital scanner to perform intraoral scanning to obtain the patient's first dentition information and occlusal relationship; illustratively, a scanner (TRIOS 3; 3Shape A / S) can be used for intraoral scanning to obtain the patient's first dentition information in a polygonal file format (STL / PLY), including the entire dentition and occlusal record.

[0025] S3: Control the patient's mouth opening degree to a preset size; when the mouth is opened to the preset size, the shape of the cyst stoma is consistent with the shape of the patient's closed mouth; In some embodiments, the minimum preset size is 2 cm.

[0026] The normal opening degree of a patient is usually placed between the upper and lower incisors, three and a half horizontal fingers, about 4 centimeters. After surgical operations inside the oral cavity, patients are often unable to restore normal opening degree in a short period of time due to pain, suture traction, local swelling and other reasons. For patients after cyst surgery in the posterior teeth area, the mouth opening degree is likely to be limited, including mild opening limitation: only two horizontal fingers can be put in; moderate opening limitation: only one horizontal finger can be put in; severe mouth opening limitation: not one horizontal finger can be put in; trismus: the mouth cannot be opened at all. Therefore, how to make accurate impressions when the patient cannot achieve normal opening degree is a problem that must be solved clinically. When the patient's opening degree is within 20mm, the bilateral condyles only rotate in the joint. The preset size of the mouth opening of the present invention is 20mm, that is, when the patient has moderate mouth opening limitation, an impression of the stoma in the mouth can be achieved.

[0027] S4: placing an impression material in the cyst stoma at a preset size, and pressing the impression material at the opening of the cyst stoma and the connecting channel with the cystic cavity with a preset pressure to obtain a first impression of the cyst stoma; Furthermore, the A-type silicone rubber impression material. This material has a high consistency, called a heavy body type or a tray type, and has a strength of 1.5-4.4 N / mm after hardening (working time 1.5-3 min, coagulation time 3-6 min). Using this material to obtain the first impression of the cyst stoma can accurately obtain the morphology of the stoma and the connection part with the cyst cavity.

[0028] For example, a layer of polyethylene film (0.015–0.020 mm thick) can be used to cover the mucosal window of the cyst stoma and its surrounding tissue to prevent the impression material from falling into the cyst cavity when taking the first impression. Place a ball of type A silicone rubber impression material on the polyethylene film and press the silicone rubber into the center of the wound to a depth of about 5 mm, such as Figure 2 As shown in A. After curing, remove the silicone rubber impression and film, as shown in Figure 2 As shown in B. After removal, the edges of the silicone rubber impression can be trimmed and the groove structure in the center can be maintained to make a silicone rubber plug, such as Figure 2 Insert the silicone rubber plug into the window as shown in Figure C. Figure 2 As shown in D.

[0029] Since pressure may cause significant deformation of the oral mucosa and skin, the preset pressure is greater than the force that causes the silicone rubber to deform concavely, but will not cause significant deformation of the oral mucosa and skin related to the stoma.

[0030] The present invention provides a method for preparing a plug with multi-layer porous channels. When the patient's mouth is opened to a preset degree, a mold is taken of the shape of the cyst stoma. In this state, the cyst stoma does not deform, thereby ensuring the preparation accuracy of the plug.

[0031] S5: At the cyst stoma, alginate impression material was used to make a second impression of the cyst stoma and the affected dentition based on the first impression of the cyst stoma through the mortise and tenon structure; A second impression of the cystostomy and the affected dentition was made using alginate material (Heraplast; Kulzer Dental Ltd). The setting time of the fast-setting alginate material is 1.5 to 2.5 minutes, and the working time is not less than 75 seconds; the setting time of the conventional alginate material is 2 to 4.5 minutes, and the working time is not less than 80 seconds. After curing, the second impression of the cystostomy and the affected dentition with a mortise and tenon structure with the first impression of the cystostomy is taken out, such as Figure 2 As shown in E.

[0032] S6: obtaining a third impression of the cyst stoma and the affected dentition through digital scanning based on the second impression; In some embodiments, the second impression model is scanned using a scanner (TRIOS 3; 3Shape A / S) to generate a third impression of the cystostomy and the affected dentition in PLY / STL / OBJ format, such as Figure 2 As shown in F. This application does not limit the scanner brand, as long as it can achieve impression scanning.

[0033] The present invention places an impression material in the cyst stoma when the size is preset, and presses the impression material at the opening of the cyst stoma and the connection channel with the cystic cavity with a preset pressure to obtain a first impression of the cyst stoma; at the cyst stoma, an alginate material is used to make a second impression of the cyst stoma and the affected side dentition. In this way, the morphology of the cyst stoma and the connection channel between the stoma and the cystic cavity can be accurately obtained, avoiding the use of an oral scanner to collect the size, shape, etc. of the cystic cavity stoma in the oral cavity. The plug is tightly combined with the cyst stoma, and the edge fit is better, so that food residues cannot enter the cystic cavity to cause infection when the plug is too small, or the plug is too large to cause discomfort to the patient.

[0034] S7: obtaining second dentition information of the affected-side dentition in the oral cavity by digitally scanning the third impression; S8: According to the first dentition information, the occlusal relationship, the second dentition information and the morphology of the cyst cavity, a 3D model of the cyst cavity-stoma-dentition-occlusal relationship is obtained through a fitting algorithm, specifically including: S81: designing an anatomical crown based on the morphological contour of the cyst stoma, and drawing a marginal line of the anatomical crown; S82: using the adjacent teeth of the cystostomy as an inlay, and drawing the edge line of the inlay as the range of the clasp arm; Create a new project in the CAD software (DentalCAD ​​3.2 Elefsina; exocad GmbH). The adjacent teeth of the cystostomy are indicated as anatomical crowns for designing the plug body; the adjacent teeth are indicated as inlays with connection conditions for designing the clasp arms of the plug fixture to fix the plug body; and the opposing teeth are indicated as Figure 4 As shown. The orange one is the "opposing tooth", the purple one is the "anatomical crown", and the blue one is the "inlay base". The "connector" is designed in the Exocad design software. In the "connecting rod view" of the software, there are many shapes to choose from, and the minimum cross-sectional area is 9mm 2 .

[0035] S83: matching the overlapping area of ​​the dentition according to the first dentition information, the occlusal relationship, the second dentition information and the morphology of the cavity, and then performing a fitting algorithm to obtain an initial 3D model of the 3D model of the cavity-stoma-dentition-occlusal relationship; The first dentition information, occlusal relationship, second dentition information, and the morphology of the capsule cavity are imported into the project to generate a digital dental model. The data are then superimposed using the best fit algorithm by matching the three anatomical reference points in the overlapping area of ​​the dentition to display the initial 3D model of the plug. Figure 5 As shown in B and C. Since the image is three-dimensional data, if only 1-2 points are matched, the system cannot automatically match accurately. If too many matching points are selected, on the one hand, the computer matching efficiency is increased, and on the other hand, the computer matching accuracy may be reduced due to errors in point selection. In this application, three anatomical reference points are used, which has high matching accuracy and efficiency.

[0036] S84: Determine the length of the plug extending into the cystic cavity according to the shape of the cystic cavity; the depth of the cystic cavity is used as the length of the plug extending into the cystic cavity.

[0037] In some embodiments, the plug body portion of the plug, that is, the portion that penetrates into the cystic cavity, is set to have a diameter and contour that are the same as the diameter and contour of the cyst stoma. The diameter of the portion of the plug that extends into the cystic cavity is mainly based on the diameter and contour of the cyst stoma. If it is much larger than the stoma, it may be difficult for the patient to put it in place when taking it off and wearing it by themselves. Pain will also affect the patient's use. If it is too small, the stoma cannot be completely closed, which not only affects the closure of the window, but also causes the plug to be embedded and dislocated into the cystic cavity, resulting in poor retention stability, and food is easily retained, affecting the cleanliness of the cystic cavity.

[0038] In existing research, in order to better drain the cystic fluid in the cystic cavity, the size and shape of the plug body are usually designed to fit the cystic cavity. However, as the cystic fluid is drained, the cystic cavity gradually heals and the cavity shrinks. An oversized plug body will also lead to a second visit to the doctor and replacement of the plug. In this application, the two are set to be the same, ensuring that the plug is tightly combined with the stoma, meeting the comfort requirement and achieving "one visit" at the same time.

[0039] Furthermore, after determining the length of the plug extending into the cystic cavity according to the shape of the cystic cavity, the method further includes: The number and diameter of the flushing and drainage holes in the plug are determined according to the diameter and outline of the cyst stoma, the depth of the cyst cavity, and the severity of the cyst. Each of the flushing and drainage holes extends toward the cystic cavity, and the number of channels, number of layers and aperture of the backflow holes in the plug are determined according to the number of flushing and drainage holes, the depth of the cystic cavity and the severity of the cyst.

[0040] Furthermore, the number of the flushing and drainage holes is 3, such as Figure 6 As shown in the figure, three irrigation and drainage holes are set, located on the occlusal surface of the cyst stoma, in a position that does not affect the occlusal contact; their functions are: 1. Drain the cyst fluid in a natural state and release the pressure in the cyst; 2. It is convenient for patients to use the oral irrigation needle by themselves, insert the needle into the hole, pressurize and push the syringe to complete the irrigation. At the same time, other irrigation and drainage holes can drain the liquid in the cyst cavity. Therefore, the diameter of the irrigation and drainage hole is larger than the diameter of the irrigation needle.

[0041] Furthermore, the number of layers of the backflow holes is 3, which are located at the bottom of the capsule cavity, 1 / 3 and 2 / 3 of the depth of the capsule cavity respectively; a backflow hole is opened on the contact surface between each hole and the capsule cavity, such as Figure 7 shown.

[0042] The channel is designed into three layers. Generally, the plug is inserted into the cyst cavity and divided into three equal parts according to the height. The channels are located at the bottom, lower 1 / 3 and middle 1 / 3 of the cyst cavity, respectively. They penetrate in the buccal and lingual directions and in the proximal and distal directions to ensure that the flushing fluid can be discharged smoothly to the surrounding areas. At the same time, it can also ensure that the cystic fluid around can be drained into the channel, and even through capillary action, the cystic fluid can be drained out and discharged from the flushing and drainage holes. The angle of the plug inserted into the cyst cavity is generally inclined to the horizontal low position, or as vertical as possible to the ground plane, because the cystic fluid will flow to the low position, so the drainage channel will also be set at the lowest point.

[0043] The channels and openings are designed in a one-step process using software, and the diameter of the channels is set to be the same as the diameter of the irrigation and drainage holes.

[0044] The plug prepared in the present application has multiple layers of porous channels, and the cystic fluid can be discharged from the channels by capillary action. The cystic cavity can also be flushed as needed, thereby promoting the recovery of the cystic cavity.

[0045] S85: Determine a 3D model of the cavity-stoma-dentition-occlusal relationship based on the height of the plug, the angle of penetration into the cavity, the edge line of the anatomical crown, the edge line of the inlay and the initial 3D model.

[0046] S9: A plug with multiple layers of porous channels is prepared based on a 3D model of the cyst-stoma-dentition-occlusion relationship.

[0047] Furthermore, the preparation of the plug with multiple layers of porous channels is specifically carried out by using a 3D printer to print according to the 3D model of the plug, thereby completing the preparation of the plug with multiple layers of porous channels.

[0048] The plug made by this method has an occlusal function and can meet the occlusal contact with the opposing teeth.

[0049] In some embodiments, a soft jaw pad resin material is selected as the 3D printing material. The material is relatively hard, but it is not completely indeformable. After the temperature rises, it will soften a little. The plug body and the bite part of the prepared plug are elastic. On the one hand, in the chewing state, the elastic bite part can play a weak buffering role, relieving the excessive pressure of the plug on the soft and hard tissues or cystic cavity of the stoma under the chewing function state; on the other hand, it can also play a spatial support role, preventing the adjacent teeth of the stoma from tilting toward the stoma direction and the elongation of the teeth of the stoma; moreover, the elastic plug body allows the plug to be better and more tightly combined with the cyst stoma.

[0050] The present invention places an impression material in the cyst stoma when the size is preset, and presses the impression material at the opening of the cyst stoma and the connection channel with the cystic cavity with a preset pressure to obtain a first impression of the cyst stoma; at the cyst stoma, an alginate material is used to make a second impression of the cyst stoma and the affected side dentition. In this way, the morphology of the cyst stoma and the connection channel between the stoma and the cystic cavity can be accurately obtained, avoiding the use of an oral scanner to collect the size, shape, etc. of the cystic cavity stoma in the oral cavity. The plug is tightly combined with the cyst stoma, and the edge fit is better, so that food residues cannot enter the cystic cavity to cause infection when the plug is too small, or the plug is too large to cause discomfort to the patient.

[0051] When the cyst stoma is in the oral vestibule area, there are no adjacent teeth around the stoma, and the plug cannot be fixed by a clasp or other fixing parts. The drainage tube / drainage strip can only be fixed to the mucosal surface adjacent to the stoma by suture suturing. The preparation method of the present application can achieve a tight combination of the plug and the cyst stoma. Even if there is no fixing part for fixation, it can meet the fixation of the plug when the cyst stoma is in the oral vestibule area, avoid the additional invasive operation of suturing, and simplify and shorten the treatment process.

[0052] Another aspect of the present invention provides a plug having multiple layers of porous channels, which is obtained by using any of the preparation methods described above. Figure 3 A schematic diagram of a plug structure with multi-layer porous channels prepared in accordance with an embodiment of the present invention, wherein Figures A to F show the plug's clamping ring fixation, flushing and drainage hole structure, and multi-layer channel structure from multiple angles. Fig. 9 Schematic cross-sectional view of a plug prepared in an embodiment of the present invention, wherein the plug comprises a plug body 2, a fixing portion 1, and an engaging portion 3; The occlusal part 3 connects the plug body 2 and the fixing part 1 and is made of elastic material; a plurality of flushing and drainage holes are provided on the occlusal surface with the oral cavity; The plug body 2 is used to support the cyst stoma and penetrate into the cyst cavity 4, and is made of elastic material; each of the flushing and drainage holes extends toward the cyst cavity, and a multi-layer channel is provided in the part of the plug body that penetrates into the cyst cavity; The fixing part 1 is inserted into the undercut area of ​​the affected dentition to connect the occlusal part 3 and the affected dentition. The tip of the clasp enters the undercut area of ​​the adjacent tooth to form a restraining lock, and the clasp arm body and the clasp arm shoulder do not enter the undercut area of ​​the abutment tooth. The clasp as a whole can strengthen the retention and stability of the plug body, prevent the occlusal part from dislocating, and play a supporting and stabilizing role.

[0053] In some embodiments, if the stoma is located in the molar area, the plug is fixed to the adjacent abutment of the affected side dentition by a clasp, i.e., the fixing part 1. The structure of the clasp can be seen. Fig. 9 If the stoma is located in the vestibule area of ​​the oral cavity, the clasp of the fixing part 1 is not required for fixation. Based on the first impression of the cyst stoma 5, a 3D scan is performed to prepare a plug without a clasp. The contact portion between the plug without a clasp and the stoma can be slightly thickened to ensure that the plug is tightly combined with the stoma without causing discomfort to the patient.

[0054] The plug in the present application uses CAD / CAM (computer-aided design and manufacturing) which is time-saving, low-cost, and requires little labor, and can be completed in one visit, thereby improving patient satisfaction. Secondly, the length of the plug inserted into the cyst is sufficient, and the multi-layer porous channel is conducive to flushing and maintaining the patency of the cyst. In addition, the diameter of the porous channel can be customized so that a vacuum-like device can be connected for active decompression. At the same time, the design of the fixing part improves the edge sealing and retention of the soft tissue, avoiding accidental swallowing. Moreover, the plug is made of elastic resin, which is easy to insert and wear, and is highly comfortable. Finally, compared with the decompression device sutured to the surrounding soft tissue, the smooth surface and detachable nature of the plug are more conducive to the maintenance of daily oral hygiene.

[0055] It should be noted that the terms used in the present invention are only for describing specific embodiments, rather than limiting the scope of the present application. As shown in the present specification, unless the context clearly indicates an exception, the words "one", "a", "a kind of" and / or "the" do not specifically refer to the singular, but may also include the plural. The terms "include", "comprise" or any other variant thereof are intended to cover non-exclusive inclusion, so that the process, method or device including a series of elements includes not only those elements, but also includes other elements not explicitly listed, or also includes elements inherent to such process, method or device. In the absence of more restrictions, the elements defined by the sentence "include one..." do not exclude the presence of other identical elements in the process, method or device including the elements.

[0056] It should also be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention. Unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", etc. should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be an indirect connection through an intermediate medium, or it can be a connection between the two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0057] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein by equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the technical solutions of the embodiments of the present invention.

Claims

1. A method for preparing a plug having multiple layers of porous channels, characterized in that: The preparation method comprises the following steps: The morphology of the cyst cavity is obtained by scanning the patient's jaw hard tissue data in the open state through CT; Use a digital scanner to perform intraoral scanning to obtain the patient's first dentition information and occlusal relationship; Control the patient's mouth opening degree to a preset size; when the mouth is opened to the preset size, the shape of the cyst stoma is consistent with the shape of the patient's closed mouth; At a preset size, placing an impression material in the cyst stoma, and pressing the impression material at the opening of the cyst stoma and the connecting channel with the cystic cavity with a preset pressure to obtain a first impression of the cyst stoma; At the cyst stoma, alginate material is used to make a second impression of the cyst stoma and the affected side dentition through a mortise and tenon structure based on the first impression of the cyst stoma; Based on the second impression, obtaining a third impression of the cyst stoma and the affected dentition by digital scanning; Acquire the second dentition information of the affected-side dentition in the oral cavity by digitally scanning the third impression; According to the first dentition information, the occlusal relationship, the second dentition information and the morphology of the cyst cavity, a 3D model of the cyst cavity-stoma-dentition-occlusal relationship is obtained through a fitting algorithm; A plug with multiple layers of porous channels is prepared based on the 3D model of the cyst cavity-stoma-dentition-occlusion relationship.

2. The method for preparing a plug having multi-layer porous channels according to claim 1, characterized in that: The impression material is type A silicone rubber impression material.

3. The method for preparing a plug having multi-layer porous channels according to claim 1, characterized in that: The method of obtaining the 3D model of the cavity-stoma-dentition-occlusion relationship by a fitting algorithm based on the first dentition information, the occlusal relationship, the second dentition information and the morphology of the cavity specifically includes: The morphological outline of the cyst stoma is used to design an anatomical crown, and the edge line of the anatomical crown is drawn; The adjacent teeth of the cystostomy are used as inlays, and the edge line of the inlay is drawn; According to the first dentition information, the occlusal relationship, the second dentition information and the morphology of the cavity, the overlapping areas of the dentition are matched, and then a fitting algorithm is performed to obtain an initial 3D model of the cavity-stoma-dentition-occlusal relationship; Determine the length of the plug extending into the cystic cavity according to the morphology of the cystic cavity; The 3D model of the cavity-stoma-dentition-occlusal relationship is determined based on the height of the plug, the angle of penetration into the cavity, the edge line of the anatomical crown, the edge line of the inlay and the initial 3D model.

4. The method for preparing a plug having multi-layer porous channels according to claim 3, characterized in that: After determining the length of the plug inserted into the cystic cavity according to the morphology of the cystic cavity, the following steps are also included: The number and diameter of the flushing and drainage holes in the plug are determined according to the diameter and outline of the cyst stoma, the depth of the cyst cavity, and the severity of the cyst. Each of the flushing and drainage holes extends toward the cystic cavity, and the number of channels, number of layers and aperture of the backflow holes in the plug are determined according to the number of flushing and drainage holes, the depth of the cystic cavity and the severity of the cyst.

5. The method for preparing a plug having multi-layer porous channels according to claim 4, characterized in that: The number of the flushing and drainage holes is 3.

6. The method for preparing a plug having multi-layer porous channels according to claim 4, characterized in that: The number of layers of the backflow holes is 3, which are located at the bottom of the capsule cavity, 1 / 3 and 2 / 3 of the depth of the capsule cavity respectively; A backflow hole is provided on the contact surface between each channel and the cyst cavity.

7. The method for preparing a plug having multi-layer porous channels according to claim 3, characterized in that: The length of the plug extending into the cystic cavity is determined according to the shape of the cystic cavity, specifically, the depth of the cystic cavity is used as the length of the plug extending into the cystic cavity.

8. The method for preparing a plug having multi-layer porous channels according to claim 3, characterized in that: The preparation of the plug with multi-layer porous channels is carried out by using a 3D printer to print the 3D model of the cyst cavity-stomach-dentition-occlusion relationship, thereby completing the preparation of the plug with multi-layer porous channels.

9. The method for preparing a plug having multi-layer porous channels according to claim 3, characterized in that: The printing material is soft jaw pad resin material.

10. A plug having multiple layers of porous channels, obtained by the preparation method according to any one of claims 1 to 9, characterized in that: The plug includes a plug body, a fixing portion, and a bite portion; The occlusal part connects the plug body and the fixing part and is made of elastic material; the contact surface with the oral cavity is provided with multiple flushing and drainage holes; The plug body is used to support the cyst stoma and penetrate into the cyst cavity, and is made of elastic material; each of the flushing and drainage holes extends toward the cyst cavity, and a multi-layer channel is provided in the part of the plug body that penetrates into the cyst cavity; The fixing part is inserted into the undercut area of ​​the affected-side dentition to connect the occlusal part and the affected-side dentition.

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