Gingival crevicular fluid collecting device and method and manufacturing method of sampling probe

Abstract

The invention relates to a gingival crevicular fluid collection device and method and a manufacturing method of a sampling probe, and belongs to the field of gingival crevicular fluid collection. The gingival crevicular fluid collection device comprises the sampling probe, and the sampling probe comprises a needle body matched with the extension form of a gingival crevicular bottom; the sampling test paper covers the needle body; when the sampling probe enters the gingival sulcus bottom, the sampling test paper absorbs liquid in the gingival sulcus bottom. According to the invention, the sampling probe fitting the trend of the gingival sulcus is adopted, and the range of the probe extends from the proximal middle to the distal middle of the cheek (tongue) side, so that an operator can simultaneously collect a plurality of sites, the gingival sulcus epithelium is not easy to puncture, non-specific exudation is reduced, and the accuracy and efficiency of gingival sulcus fluid collection are improved.

Description

Technical Field

[0001] This invention belongs to the technical field of gingival crevicular fluid collection devices, and particularly relates to a gingival crevicular fluid collection device and collection method, and a method for manufacturing a sampling probe. Background Technology

[0002] Periodontitis is a chronic infectious disease caused by plaque biofilm and ranks as the sixth most prevalent disease worldwide. World Health Organization (WHO) data shows that approximately 50% of adults globally have periodontal tissue damage, with severe periodontitis prevalent in 11.2%. Periodontitis not only leads to gingival bleeding, alveolar bone resorption, and tooth loosening and loss, but also has a bidirectional association with systemic diseases such as diabetes, cardiovascular disease, and Alzheimer's disease. Recent studies have confirmed that periodontal pathogens such as *Porphyromonas gingivalis* and *Actinomyces actinomycetes* can spread through the bloodstream, exacerbating atherosclerotic plaque formation; therefore, early diagnosis of periodontitis is urgent.

[0003] Gingival crevicular fluid (GCF), serving as a "liquid biopsy" sample of the periodontal tissue microenvironment, directly reflects the local inflammatory state through dynamic changes in its composition. Healthy GCF secretion is approximately 0.5-2.4 μL per day, primarily composed of electrolytes, immunoglobulins, and a small number of neutrophils. In active periodontitis, however, GCF secretion surges to 20-50 μL per tooth, becoming rich in pro-inflammatory factors such as IL-1β, TNF-α, and MMP-8, as well as bone resorption markers like RANKL. Furthermore, since GCF is partly derived from blood, its detection is of great significance in guiding the analysis of various systemic diseases. Compared to saliva and serum, GCF exhibits site specificity and time sensitivity, accurately capturing real-time pathological changes in individual teeth and providing a molecular basis for personalized treatment.

[0004] Existing techniques for collecting gingival crevicular fluid mainly include the sampling test strip (hygroscopic paper tip) adsorption method, the micropipette (capillary) sampling method, and the gingival crevicular irrigation technique. However, these methods still have significant shortcomings in terms of sampling efficiency and accuracy, which restricts their clinical application. For example, the capillary method usually requires more than 30 minutes to complete a single-point sampling; although the hygroscopic paper tip / sampling test strip method shortens the sampling time to a single site to 30 seconds, its insertion can easily irritate the gingival crevicular epithelium, causing non-specific exudation and interfering with the quantitative detection of biomarkers; the gingival crevicular irrigation technique is complicated to operate and has the problem of diluting the gingival crevicular fluid. Summary of the Invention

[0005] In view of the shortcomings of the prior art, the purpose of the invention is to provide a gingival crevicular fluid collection device and collection method, and a method for manufacturing a sampling probe, so as to improve sampling efficiency and accuracy.

[0006] A first aspect of the present invention provides a gingival crevicular fluid collection device, comprising:

[0007] Sampling probe, including a needle body that matches the morphology of the gingival sulcus floor extension;

[0008] Sampling test strip, covering the needle body;

[0009] When a probe is inserted into the bottom of the gingival sulcus, the sampling strip absorbs the fluid in the bottom of the gingival sulcus.

[0010] A second aspect of the present invention provides a gingival crevicular fluid collection device, comprising:

[0011] The sampling probe includes a needle body that matches the extension shape of the gingival sulcus; the needle body is a hollow tube with a central hole, and the sidewall of the needle body has a through hole communicating with the central hole.

[0012] Furthermore, the gingival crevicular fluid collection device also includes a wire harness, which is threaded through the hollow tube; the wire harness is hydrophilic.

[0013] Furthermore, the gingival crevicular fluid collection device also includes a grip handle, and one end of the sampling probe is movably connected to the grip handle.

[0014] Furthermore, the grip handle includes a hand handle, a clamp, and a head cap. The head cap is threaded to one end of the hand handle to form a receiving cavity for accommodating the clamp. One end of the sampling probe passes through the head cap and is inserted into the receiving cavity, and the clamp holds the sampling probe in place.

[0015] A third aspect of the present invention provides a method for collecting gingival crevicular fluid using the gingival crevicular fluid collection device described above, comprising:

[0016] Select a sampling probe that corresponds to the shape of the tooth to be sampled;

[0017] Take a sampling test strip that matches the tooth position to be sampled; fold the sampling test strip in half, with the folded end facing the root of the tooth position to be sampled;

[0018] Insert the sampling probe into the sampling test paper along the open end of the sampling test paper, and together the two enter the gingival sulcus along the gingival margin of the tooth to be sampled, so that the sampling test paper can fully contact the fluid in the gingival sulcus. Hold for 10s-30s, and then remove the gingival sulcus fluid collection device.

[0019] A fourth aspect of the present invention provides a method for collecting gingival crevicular fluid using the gingival crevicular fluid collection device described above, comprising:

[0020] Select a sampling probe that corresponds to the shape of the tooth to be sampled;

[0021] The sampling probe is inserted into the gingival sulcus along the gingival margin of the tooth to be sampled, so that the fluid in the gingival sulcus enters the central hole through the through hole. The probe is held for 10-30 seconds, and then the gingival sulcus fluid collection device is removed.

[0022] A fifth aspect of the present invention provides a method for manufacturing a sampling probe for a gingival crevicular fluid collection device as described above, comprising:

[0023] a. Acquire and register intraoral scan and CT data;

[0024] b. Extract the gingival margin and cementoenamel boundary curves;

[0025] c. Obtain the average curve of the line connecting the central axes;

[0026] d. Processing sampling probes: Based on the average curve data, a forming device is used to bend stainless steel wires to form sampling probes.

[0027] Further, step a involves acquiring and registering oral scan and CT data, including acquiring three-dimensional oral scan STL data of the dentition and CBCT image DICOM data of the dentition; performing three-dimensional reconstruction of the CBCT images of the dentition and exporting them as STL data; and performing registration processing on the oral scan and CT STL data in the reverse engineering software.

[0028] Furthermore, step b involves extracting the gingival margin and cementoenamel boundary curves, which includes using curvature analysis in reverse engineering software to extract the gingival margin curve from the oral scan model and the CEJ curve from the CT model, and exporting them as IGES data to obtain the three-dimensional coordinates of the curves.

[0029] Further, step c, obtaining the average curve of the central axis connection, includes calculating the average curve of multiple sets of gingival margin curves and the corresponding CEJ curve central axis connection based on the three-dimensional coordinates of the gingival margin curve and the CEJ curve, using arc length parameterization and resampling methods.

[0030] The above technical terms are explained as follows:

[0031] 1. CEJ (Cemento-enamel junction) refers to the junction between the enamel and cementum at the neck of the tooth. On the tooth body, it is a line that surrounds the neck of the tooth.

[0032] 2. Arc length parameterization refers to taking a curve in a given space, and arbitrarily selecting a point P0(x0,y0,z0) on it as the starting point for calculating the arc length. Using the arc length integral formula, the arc length from any point on the curve to P0 can be calculated. Therefore, there is a one-to-one correspondence between points on the curve and the arc lengths between them and P0. Thus, the curve can be represented as a parametric curve with parameters related to gastrointestinal health; this representation method is called arc length parameterization of the curve.

[0033] 3. Resampling refers to resampling a set of discrete data points to generate new sampling points.

[0034] The beneficial effects of this invention are as follows:

[0035] Using a sampling probe that conforms to the gingival sulcus, the probe range extends from the mesial to the distal buccal (lingual) side, allowing the operator to collect samples from multiple sites simultaneously. This reduces the risk of puncturing the gingival sulcus epithelium, minimizes nonspecific exudation, and improves the accuracy and efficiency of gingival crevicular fluid collection.

[0036] A digital design method for sampling probes based on a large amount of oral scan and CT data enables the obtained sampling probe shape to be adapted to the gingival sulcus contour features of most people, thereby improving the efficiency and accuracy of gingival crevicular fluid collection. Attached Figure Description

[0037] The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Throughout the drawings, the same reference numerals denote the same parts. It is obvious that the drawings described below are merely some embodiments of the present invention, and those skilled in the art can obtain other drawings based on these drawings.

[0038] Figure 1 This is a schematic diagram of the gingival crevicular fluid collection device of the present invention;

[0039] Figure 2 This is a schematic diagram of the hollow sampling probe of the present invention;

[0040] Figure 3 This is a schematic diagram of the wire harness structure of the present invention;

[0041] Figure 4 This is a schematic diagram of the solid sampling probe structure of the present invention;

[0042] Figure 5 This is a schematic diagram of the grip handle of the present invention;

[0043] Figure 6 This is a schematic diagram of the structure of the headgear of the present invention;

[0044] Figure 7 This is a flowchart illustrating the fabrication process of the sampling probe of this invention.

[0045] Figure label:

[0046] 1. Sampling probe; 11. Center hole; 12. Through hole; 13. Wire harness;

[0047] 2. Connector; 3. Head cap; 4. Handle grip. Detailed Implementation

[0048] To enable those skilled in the art to better understand the technical solutions in the embodiments of the present invention, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. It should be understood that these descriptions are merely exemplary and are not intended to limit the scope of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of the present invention.

[0049] Furthermore, descriptions of well-known structures and techniques are omitted in the following description to avoid unnecessarily obscuring the concepts disclosed in this invention.

[0050] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating orientation or positional relationships based on the orientation or positional relationships shown in the accompanying drawings, are only for the convenience of describing the invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance. The terms "installed," "connected," and "linked" should be interpreted broadly; for example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal communication of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0051] Exemplary embodiments will now be described in detail, examples of which are illustrated in the accompanying drawings. When the following description relates to the drawings, unless otherwise indicated, the same numerals in different drawings denote the same or similar elements. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with the present invention. Rather, they are merely examples of methods and systems consistent with some aspects of the invention as detailed in the appended claims.

[0052] This invention proposes a gingival crevicular fluid collection device and collection method, as well as a method for manufacturing a sampling probe 1. The sampling probe 1, which conforms to the trend of the gingival crevicular sulcus, can collect multiple sites simultaneously, thereby improving the accuracy and efficiency of gingival crevicular fluid collection.

[0053] The present invention proposes a gingival crevicular fluid collection device, comprising:

[0054] Sampling probe 1, comprising a needle body that matches the extension morphology of the gingival sulcus floor;

[0055] Sampling test strip, covering the needle body;

[0056] When a probe is inserted into the bottom of the gingival sulcus, the sampling strip absorbs the fluid in the bottom of the gingival sulcus.

[0057] The gingival crevicular fluid collection device of the present invention uses a sampling probe 1 that matches the extension shape of the gingival crevicular bottom, and is combined with a sampling test strip, so that the sampling test strip is inserted into the gingival crevicular under the action of the sampling probe 1, so as to realize multi-point collection of gingival crevicular fluid, thereby improving the accuracy and efficiency of gingival crevicular fluid collection.

[0058] A second aspect of the present invention provides a gingival crevicular fluid collection device, comprising:

[0059] The sampling probe 1 includes a needle body that matches the extension shape of the gingival sulcus; the needle body is a hollow tube with a central hole 11, and the side wall of the needle body is provided with a through hole 12 that communicates with the central hole 11.

[0060] In this embodiment, the gingival crevicular fluid collection device has a hollow tube structure for the sampling probe 1, and a through hole 12 is provided on the side wall of the hollow tube with a central hole 11. When the sampling probe 1 is inserted into the gingival sulcus, the gingival crevicular fluid will seep into the central hole 11 through the through hole 12, thereby realizing the collection of gingival crevicular fluid.

[0061] Alternatively, a sampling test strip can be wrapped around the hollow tube sampling probe 1 to achieve the same result in collecting gingival crevicular fluid.

[0062] Furthermore, the gingival crevicular fluid collection device also includes a wire harness 13, which is inserted into the hollow tube; the wire harness 13 is hydrophilic.

[0063] For the sampling probe 1 of the hollow tube, a wire bundle 13 can be set in the central hole 11. The wire bundle 13 is hydrophilic and can absorb gingival crevicular fluid.

[0064] A replaceable braided filament bundle 13 is installed inside the hollow tube. The filaments are made of an inert polymer material with a hydrophilic surface, such as polyurethane, polypropylene, or nylon, to carry gingival crevicular fluid samples without affecting the elution and recovery of biochemical molecules in the samples.

[0065] Furthermore, the gingival crevicular fluid collection device also includes a grip handle 4, and one end of the sampling probe 1 is movably connected to the grip handle 4.

[0066] In specific operation, the sampling probe 1 of the present invention is movably mounted on the grip handle 4, which enables the sampling probe 1 to be replaced promptly after use.

[0067] Furthermore, the grip handle 4 includes a hand handle, a clamp, and a cap 3. The cap 3 is threaded to one end of the hand handle to form a receiving cavity for accommodating the clamp. One end of the sampling probe 1 passes through the cap 3 and is inserted into the receiving cavity, and the clamp holds the sampling probe 1 in place.

[0068] The specific structure of the grip handle 4 may include three parts: a hand grip, a clamp, and a cap 3. The hand grip is the part held by the operator and has an external thread at the head. The cap 3 is the part that pulls the elastic clamp towards the center and has an internal thread at the tail. The cap 3 is threaded to one end of the hand grip to form a receiving cavity for accommodating the clamp. The clamp is elastic and facilitates clamping the end of the sampling probe 1 with the connector 2.

[0069] After use, sampling probe 1 can be replaced by loosening the cap 3.

[0070] A third aspect of the present invention provides a method for collecting gingival crevicular fluid using the gingival crevicular fluid collection device described above, comprising:

[0071] Select sampling probe 1 that corresponds to the shape of the tooth to be sampled;

[0072] Take a sampling test strip that matches the tooth position to be sampled; fold the sampling test strip in half, with the folded end facing the root of the tooth position to be sampled;

[0073] Insert the sampling probe 1 into the sampling test paper along the open end of the sampling test paper, and together the two enter the gingival sulcus along the gingival margin of the tooth to be sampled, so that the sampling test paper can fully contact the liquid in the gingival sulcus. Hold for 10s-30s, and then remove the gingival sulcus fluid collection device.

[0074] For sampling probe 1 with a solid needle structure, a sampling test strip is required to collect gingival crevicular fluid. The specific procedure is as follows: First, select the sampling probe 1 corresponding to the tooth and sampling site (labial / buccal or lingual / palatal side) to be sampled. Fix the sampling probe 1 to the tooth using the clamp inside the handle 4. Next, take a sampling test strip with a width matching the mesial and distal dimensions of the sampling site. Fold the test strip along its long axis, with the folded end facing the root and the opening facing the crown. Position the sampling probe 1 on the open side of the test strip, i.e., towards the crown. The sampling probe 1 contacts the fold line of the test strip and enters the gingival sulcus along the gingival margin, moving apically towards the tooth surface until it is positioned above the bottom of the gingival sulcus, thus placing the test strip in place within the sulcus. After the test strip is in place, leave the sampling probe 1 in the sulcus for 5 seconds to allow sufficient contact between the test strip and the epithelium within the gingival sulcus for absorption of the gingival crevicular fluid. It can then be removed, and if necessary, replaced with a sampling probe 1 suitable for the next sampling site. The sampling strip should remain in the gingival sulcus for 10-30 seconds to complete the sampling. After sampling, remove the sampling strip from the gingival sulcus. The sampling strip carrying the gingival crevicular fluid sample can be used for subsequent biochemical analysis.

[0075] The sampling test strips mentioned above can be made of filter paper.

[0076] A fourth aspect of the present invention provides a method for collecting gingival crevicular fluid using the gingival crevicular fluid collection device described above, comprising:

[0077] Select sampling probe 1 that corresponds to the shape of the tooth to be sampled;

[0078] The sampling probe 1 is inserted into the gingival sulcus along the gingival margin of the tooth to be sampled, so that the fluid in the gingival sulcus enters the central hole 11 through the through hole 12. The fluid stays for 10-30 seconds, and then the gingival sulcus fluid collection device is removed.

[0079] For sampling probe 1, which is a hollow tube structure with a central hole 11, a wire bundle 13 can be set inside the hollow tube. The operation method of sampling probe 1 with this structure is relatively simple compared with sampling probe 1 with a solid structure. Just insert sampling probe 1 into the gingival sulcus along the gingival margin of the tooth to be sampled, so that the fluid in the gingival sulcus enters the central hole 11 through the through hole 12, stays for 10s-30s, and the gingival sulcus fluid can be collected.

[0080] A fifth aspect of the present invention provides a method for manufacturing a sampling probe 1 of the gingival crevicular fluid collection device as described above, comprising:

[0081] a. Acquire and register intraoral scan and CT data;

[0082] b. Extract the gingival margin and cementoenamel boundary curves;

[0083] c. Obtain the average curve of the line connecting the central axes;

[0084] d. Processing sampling probe 1: Based on the average curve data, a forming device is used to bend the stainless steel wire to form sampling probe 1.

[0085] Further, step a involves acquiring and registering oral scan and CT data, including acquiring three-dimensional oral scan STL data of the dentition and CBCT image DICOM data of the dentition; performing three-dimensional reconstruction of the CBCT images of the dentition and exporting them as STL data; and performing registration processing on the oral scan and CT STL data in the reverse engineering software.

[0086] Furthermore, step b involves extracting the gingival margin and cementoenamel boundary curves, which includes using curvature analysis in reverse engineering software to extract the gingival margin curve from the oral scan model and the CEJ curve from the CT model, and exporting them as IGES data to obtain the three-dimensional coordinates of the curves.

[0087] Further, step c, obtaining the average curve of the central axis connection, includes calculating the average curve of multiple sets of gingival margin curves and the corresponding CEJ curve central axis connection based on the three-dimensional coordinates of the gingival margin curve and the CEJ curve, using arc length parameterization and resampling methods.

[0088] The design principle of sampling probe 1 is as follows: The design of sampling probe 1 conforms to the anatomical characteristics of natural teeth. After a tooth has fully erupted, under normal physiological conditions, the bottom of the gingival sulcus is located at the cementoenamel junction. Therefore, sampling probe 1 and sampling filter paper need to first enter the gingival sulcus through the gingival margin and move along the tooth surface towards the root. After entering the gingival sulcus, their deepest point should not exceed the cementoenamel junction, and they should also conform to the curvature of the tooth surface. This prevents both breaching the junctional epithelium attached to the cementoenamel junction at the bottom of the gingival sulcus and breaching the gingival sulcus epithelium in the free gingival region, thereby avoiding nonspecific exudation and improving sampling accuracy.

[0089] Based on the design principle of the sampling probe 1 described above, this invention uses a digital method to separately mark the gingival margin and cementoenamel junction at the same tooth position, serving as the starting and ending lines for the sampling probe 1 to enter the gingival sulcus. Since the fold line of the sampling filter paper is always located in the root direction of the sampling probe 1, the morphology of the sampling probe 1 should be between the gingival margin and the cementoenamel junction, and should allow for variations in the morphology of the gingival margin and cementoenamel junction due to differences in tooth development between different individuals. Therefore, a mathematical calculation method is chosen to group the two three-dimensional curves of the gingival margin and cementoenamel junction at a specific tooth position in the same individual into a set. On an assumed strip-shaped surface with the two three-dimensional curves as its long side, the central axis curve of this surface is obtained. Then, multiple central axis curves from different individuals at the same specific tooth position are obtained, and their average curve is obtained using mathematical calculation, serving as the final morphology of the sampling probe 1 at that tooth position.

[0090] like Figure 7 The preparation process of sampling probe 1 is shown below:

[0091] a. Acquiring and Registering Oral Scan and CT Data: Acquire 3D oral scan STL data of the dentition, as well as CBCT image DICOM data of the dentition. In medical image processing software, perform 3D reconstruction of the CBCT images of the dentition and export them as STL data. In reverse engineering software, register the STL data of the oral scan and CT scan. The purpose of this step is to align the complete tooth structure and gingival soft tissue of the same dentition on the same reference point, so as to accurately obtain their relative relationship in 3D space, laying the structural foundation for subsequent steps to extract edge lines and calculate the central axis curve.

[0092] b. Extracting the gingival margin and cementoenamel junction (CEJ) curves: In the reverse engineering software, the curvature analysis method is used to extract the gingival margin curve from the intraoral scan model and the CEJ curve from the CT model, and export them as IGES data to obtain the three-dimensional coordinates of the curves. The purpose of this step is to transform the two edge lines themselves and the spatial relationship between them into specific three-dimensional coordinate values, which facilitates the subsequent calculation of the central axis curve using mathematical methods.

[0093] c. Obtain the average curve of the central axis connection: Based on the three-dimensional coordinates of the gingival margin curve and the CEJ curve, and using arc length parameterization and resampling, calculate the average curve of multiple sets of gingival margin curves and the corresponding CEJ curve central axis connection. The purpose of this step is to eliminate individual differences in tooth and periodontal morphology among different people and at the same tooth position, and to obtain the morphology of sampling probe 1 that conforms to the gingival sulcus morphology of most people.

[0094] The specific method is as follows:

[0095] 1) Input data:

[0096] Define the gingival margin curve and corresponding CEJ curve for a specific tooth position as a group, with n groups. For the i-th group (i = 1 to n), define the gingival margin curves included in this group as A. i The CEJ curve is B. i The two curves are represented as follows:

[0097] A i :

[0098] B i :

[0099] Where P and Q are the gingival margin curve and the CEJ curve, respectively, k is the point index in the P curve, and l is the point index in the Q curve.

[0100] 2) Calculate the median curve of the two curves in each group:

[0101] First, the arc lengths of the two curves are parameterized using the following formula:

[0102]

[0103] Where L represents the arc length of the curve.

[0104] Then determine the common arc length range L. common And resampling is performed, calculated using the following formula:

[0105]

[0106]

[0107] Among them, t k The parameter represents the uniform arc length, and K represents the number of sampling points, which ranges from 50 to 100 depending on the arc length of the curve.

[0108] Finally, calculate the central axis curve C. i And obtain the arc length of the i-th central axis curve. The calculation formula is as follows:

[0109]

[0110] Among them, P i sampled [k] and Representing curve A respectively i And curve B i Under the unified arc length parameter t k The resampling points obtained by position interpolation are calculated using the following formula:

[0111] P i sampled [k] = interp(A i ,t k )

[0112]

[0113] 3) Perform global orientation alignment of the central axis curves for all groups. The calculation formula is as follows:

[0114]

[0115] in, R represents the i-th globally aligned median curve. i Represents the direction based on the principal tangent. The rotation matrix is ​​calculated using the following formula:

[0116]

[0117] Where I3 represents the identity matrix, θ iRepresents the rotation angle; Rodrigues is the formula for the Rodrigues rotation.

[0118] b i and b global The centroids of the i-th central axis curve and the global centroid are calculated using the following formula:

[0119] b i =mean(C i )

[0120]

[0121] 4) Normalize the median curves of all groups, then resample. The calculation formula is as follows:

[0122]

[0123] in, s represents the i-th normalized median curve. j The normalized global standardized arc length parameter is calculated using the following formula:

[0124]

[0125] Where M represents the number of global resampling points, and its value ranges from 100 to 200 depending on the curve arc length. L avg The average arc length of the central axis curves across all groups is calculated using the following formula:

[0126]

[0127] 5) Weighted average calculation, the formula is as follows:

[0128]

[0129] Among them, C avg [j] represents the median curve of the weighted average of all groups, ω i The weighting coefficient is calculated using the following formula:

[0130]

[0131] in, This represents the arc length of the k-th central axis curve.

[0132] d. Processing sampling probe 1: Based on the average curve data, the sampling probe 1 is bent using a special stainless steel wire forming device.

[0133] This invention relates to a digital design method for sampling probe 1 based on a large amount of oral scan and CT data, which enables the obtained sampling probe 1 to adapt to the gingival sulcus contour features of most people, thereby improving the collection efficiency and accuracy of gingival crevicular fluid.

[0134] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the embodiments of the present invention, and are not intended to limit them. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention. Any changes or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in the present invention should be included within the protection scope of the present invention.

Claims

1. A device for collecting gingival crevicular fluid, characterized in that, include: Sampling probe (1), comprising a needle body that matches the extension morphology of the gingival sulcus floor; Sampling test strip, covering the needle body; When a probe is inserted into the bottom of the gingival sulcus, the sampling strip absorbs the fluid in the bottom of the gingival sulcus.

2. A device for collecting gingival crevicular fluid, characterized in that, include: The sampling probe (1) includes a needle body that matches the extension shape of the gingival sulcus; the needle body is a hollow tube with a central hole, and the side wall of the needle body is provided with a through hole (12) that communicates with the central hole (11).

3. The gingival crevicular fluid collection device according to claim 2, characterized in that, The gingival crevicular fluid collection device also includes a wire harness (13), which is inserted into the hollow tube; the wire harness (13) is hydrophilic.

4. The gingival crevicular fluid collection device according to any one of claims 1-3, characterized in that, The gingival crevicular fluid collection device also includes a grip handle (4), and one end of the sampling probe (1) is movably connected to the grip handle (4).

5. The gingival crevicular fluid collection device according to claim 4, characterized in that, The grip handle (4) includes a hand handle, a clamp, and a cap (3). The cap (3) is threaded to one end of the hand handle to form a receiving cavity for accommodating the clamp. One end of the sampling probe (1) passes through the cap (3) and is inserted into the receiving cavity. The clamp holds the sampling probe (1).

6. A method for collecting gingival crevicular fluid using the gingival crevicular fluid collection device as described in claim 1, characterized in that, include: Select a sampling probe (1) that corresponds to the shape of the tooth to be sampled; Take a sampling test strip that matches the tooth position to be sampled; fold the sampling test strip in half, with the folded end facing the root of the tooth position to be sampled; Insert the sampling probe (1) into the sampling test paper along the open end of the sampling test paper, and together the two enter the gingival sulcus along the gingival margin of the tooth to be sampled, so that the sampling test paper can fully contact the liquid in the gingival sulcus. After staying for 10s-30s, remove the gingival sulcus fluid collection device.

7. A method for collecting gingival crevicular fluid using the gingival crevicular fluid collection device as described in claim 2 or 3, characterized in that, include: Select a sampling probe (1) that corresponds to the shape of the tooth to be sampled; The sampling probe (1) is inserted into the gingival sulcus along the gingival margin of the tooth to be sampled, so that the liquid in the gingival sulcus enters the central hole (11) through the through hole (12), stays for 10s-30s, and then the gingival sulcus fluid collection device is removed.

8. A method for manufacturing a sampling probe (1) of the gingival crevicular fluid collection device as described in any one of claims 1-5, characterized in that, include: a. Acquire and register intraoral scan and CT data; b. Extract the gingival margin and cementoenamel boundary curves; c. Obtain the average curve of the line connecting the central axes; d. Processing the sampling probe (1): Based on the average curve data, a forming device is used to bend the stainless steel wire to form the sampling probe (1).

9. The manufacturing method according to claim 8, characterized in that, Step a involves acquiring and registering oral scan and CT data, including acquiring three-dimensional oral scan STL data of the dentition and CBCT image DICOM data of the dentition; performing three-dimensional reconstruction of the CBCT images of the dentition and exporting them as STL data; and performing registration processing on the oral scan and CT STL data in the reverse engineering software.

10. The manufacturing method according to claim 8, characterized in that, Step b involves extracting the gingival margin and cementoenamel boundary curves. This includes using curvature analysis in reverse engineering software to extract the gingival margin curve from the oral scan model and the CEJ curve from the CT model, and exporting them as IGES data to obtain the three-dimensional coordinates of the curves.

11. The manufacturing method according to claim 8, characterized in that, Step c involves obtaining the average curve of the central axis connection, which includes calculating the average curve of multiple sets of gingival margin curves and the corresponding CEJ curve central axis connection based on the three-dimensional coordinates of the gingival margin curve and the CEJ curve, using arc length parameterization and resampling methods.

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