Specimen collection equipment for dental disease testing

Abstract

To provide a collection instrument for reliably and easily collecting gingival crevicular fluid in a single collection from a gingival crevicular area at a target site.SOLUTION: A collection instrument for collecting vital fluid, such as gingival crevicular fluid, is constituted of a member formed by joining a flat, elastic, plate-like support, a vital fluid collection part that is held on the surface of the support in an attachable / detachable manner and a grip. With such an operation, one end of the support is securely inserted into a gingival crevice and fixed, and one end of the vital fluid collection part is fixed near the gingival crevice or a part thereof is inserted into the gingival crevice, so that the gingival crevicular fluid can be reliably collected and held.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a method and an instrument for collecting gingival crevicular fluid or peri-implant crevicular fluid, which is a biological fluid that seeps into and remains in the gingival sulcus, as a specimen, primarily for the purpose of testing for periodontal disease (gingivitis, periodontitis) and peri-implant disease (peri-implant mucositis, peri-implantitis). [Background technology]

[0002] Currently, various clinical parameters are used in general dental clinics to examine and diagnose periodontal disease or to evaluate the effectiveness of periodontal treatment, including periodontal pocket (gingival sulcus) examination, tooth mobility tests, and X-ray examinations. The standard diagnostic method is the morphometric technique of probing depth (PD), which evaluates the degree of destruction of periodontal tissue by inserting an instrument called a probe into the periodontal pocket and measuring its depth.

[0003] However, probe testing only reveals the extent to which periodontal tissue has already been destroyed by periodontal disease, and does not reveal the degree of disease activity, which is determined by the level of inflammation at the time of testing.Furthermore, problems have been pointed out, such as the need for skill in measurement, the possibility of damaging periodontal tissue, and the fact that the judgment is subjective, uncertain, and subjective due to visual evaluation.

[0004] For this reason, in addition to the above diagnostic methods, many bacteriological and biochemical testing techniques have been proposed as objective indicators for early diagnosis and predicting the progression of periodontal disease, and attempts are being made to apply them clinically as non-invasive tests that do not use probes.

[0005] In bacteriological testing, because periodontal disease is an infectious disease in which periodontal pathogens play a major role in its onset and progression, understanding the bacterial flora and bacterial count can provide necessary information for identifying risk factors, making a diagnosis, and assessing the effectiveness of treatment. For example, methods have been devised and put into practical use to specifically detect ALP (alkaline phosphatase), an enzyme released by periodontal pathogenic bacteria in saliva, and peptidase, a trypsin-like enzyme. (Patent Document 1, Non-Patent Document 1)

[0006] Regarding biochemical methods, many have been proposed that use specific proteins and enzymes contained in the exudate leaking into the gingival crevicular fluid (gingival crevicular fluid) or saliva as test samples for periodontal disease markers for testing and diagnosis, allowing the progression of the disease to be determined. For example, diagnostic kits have been devised that measure the amount of hemoglobin or the amount of calprotectin, a calcium-binding protein, in gingival crevicular fluid or saliva (Patent Documents 2 and 3), and a diagnostic kit has also been devised that utilizes the fact that MMP (matrix metalloproteinase), a type of protease that breaks down collagen, the main component of tooth or muscle connective tissue, is related to the progression of periodontal disease (Patent Document 4).

[0007] Traditionally, saliva and gingival crevicular fluid used as test samples have been collected by dentists or dental hygienists using a collection tool made from a thin, absorbent material (product name: periodontal paper) or a toothpick-shaped paper point made from paper used in root canal treatment, etc., by pinching one end with tweezers and inserting it into the gingival sulcus or pressing it against the vicinity of the gingival sulcus.

[0008] In the case of peri-implant disease, the exudate that remains in the gap between the implant body and the gums (peri-implant crevice exudate) is also used and collected as a test sample.

[0009] Instruments for collecting such saliva and gingival crevicular fluid have been disclosed, with the invention described in Patent Document 5 being a collection instrument having a capillary tube with a flat-shaped insertion section at the tip and a biological fluid holding section extending from the base end and communicating with the capillary tube, the invention described in Patent Document 6 being a collection instrument having a brush-like bristles bundle, and the invention described in Patent Document 7 being a collection instrument having a cylindrical body with multiple thin walls stacked in the thickness direction in part of the wall. [Prior art documents] [Patent documents]

[0010] [Patent Document 1] Japanese Patent Application Publication No. 8-75729 [Patent Document 2] Japanese Patent Application Publication No. 2017-257312 [Patent Document 3] Japanese Patent Application Laid-Open No. 2016-31306 [Patent Document 4] Patent No. 3083325 [Patent Document 5] Japanese Patent Application Laid-Open No. 2001-201437 [Patent Document 6] Patent No. 4176457 [Patent Document 7] Japanese Patent Application Laid-Open No. 2017-58154 [Non-patent literature]

[0011] [Non-Patent Document 1] Hyoron Publishing Co., Ltd. "Saliva Test Handbook for Dentists and Dental Hygienists" 2008: 62-63, 68-69 Summary of the Invention [Problem to be solved by the invention]

[0012] However, when collecting gingival crevicular fluid using conventional periodontal paper molded into thin flakes or toothpick-shaped paper points held with tweezers, there are problems such as the collection tool hitting other parts of the body such as teeth or oral mucosa and becoming deformed when approaching the gingival sulcus of the intended collection site, or unintentionally sucking up saliva, reducing its ability to absorb the intended sample fluid.

[0013] In addition, because the biofluid collection part is made of paper, it lacks stiffness and strength, making it difficult to insert into the gingival sulcus.Furthermore, it instantly softens when it comes into contact with biofluid, making it difficult to fix in the desired collection site.Inexperienced users often have to replace the collection tool with a new one and start collecting again, which is inefficient.

[0014] Furthermore, in the case of peri-implant disease, it is necessary to properly collect peri-implant crevicular fluid as a test sample; however, depending on the type and style of implant body, and particularly the shape of the abutment (connection part) or superstructure (artificial tooth), the biological fluid collection part may break before the collection tool reaches the vicinity of the target site, or depending on the shape of the abutment, it may not be possible to fix it near the target site, making it difficult to collect peri-implant crevicular fluid.

[0015] The collection devices described in Patent Documents 6 and 7 have a structure and mechanism that makes it easier to collect biological fluids compared to the above-mentioned collection devices, but they have the problem that the material structure is complex, which increases manufacturing costs, and they are also difficult to fix to the collection site.

[0016] In view of the above, the present invention provides a collection device that has a simple structure but can reliably and easily collect gingival crevicular fluid or peri-implant crevicular fluid from the gingival sulcus of the target area in a single collection. [Means for solving the problem]

[0017] The present invention provides a specimen collection device for collecting gingival crevicular fluid or peri-implant crevicular fluid, comprising: The device has a flat exudate collection part, a grip part for holding the exudate collection part, and a flat support part, the exudate collection portion is made of a material capable of absorbing and retaining exudate, is a substantially rectangular body, has a grip portion near one end of a long side of the substantially rectangular body, and the other end of the long side of the exudate collection portion is an exudate absorption end; The gripping portion is made of a hydrophobic material and is provided on both sides of the flat plate-like exudate collection portion, and extends from the tip of the long side end of the approximately rectangular body toward the other long side end, but does not extend beyond the center between the other long side end and the long side end. the support part is made of a hydrophobic elastic material and has a substantially rectangular shape, the exudate collection part is detachably attached to one end of a long side of the substantially rectangular shape via a grip part, and the other end of the long side is an absorbent support end that supports the exudate absorption part; The surfaces of the support part and exudate collection part are opposite and close to each other, The long side end of the exudate collection part and the long side end of the approximately rectangular body of the support part are bonded together so as to be held in the same direction, This is a specimen collection device in which the other end of the long side of the approximately rectangular support part protrudes in the direction of the other end, compared to the other end of the long side of the exudate collection part. Preferably, the short side of the approximately rectangular shape of the support part is 0.5 to 2.0 times the short side of the approximately rectangular shape of the exudate collection part, The specimen collecting device is characterized in that the tip of the other end of the long side of the support part protrudes 0 to 5.0 mm beyond the tip of the other end of the long side of the exudate collecting part. [Effects of the Invention]

[0018] The present invention can provide a collection device that has a simple structure and that can reliably and easily collect gingival crevicular fluid or peri-implant crevicular exudate from the gingival sulcus of a target area in a single collection. [Brief explanation of the drawings]

[0019] [Figure 1] FIG. 1 is a plan view of a specimen collection device (10) according to the present invention. [Figure 2] FIG. 1 is a cross-sectional view of the specimen collection device (10) of the present invention. [Figure 3]1 is an enlarged plan view with dimensions of an embodiment of the specimen collection device (10) of the present invention. [Figure 4] FIG. 1 is a side view illustrating a scene in which gingival crevicular fluid is collected from a natural tooth using the specimen collection tool (10) of the present invention. [Figure 5] FIG. 1 is a side view illustrating a scene in which peri-implant crevice exudate from an implant body is collected using the specimen collection tool (10) of the present invention. [Explanation of symbols]

[0020] 10. Specimen collection equipment 20 Support part 20a Short side of support part 20b Support protrusion 30 Biological fluid collection section 30a Short side of biological fluid collection section 40 Gripping part 50 adhesive 60a Natural teeth 60b Artificial teeth 70 Gums 80 Gingival sulcus 80a Gingival crevicular fluid 80b Peri-implant crevicular exudate 90 Implant body DETAILED DESCRIPTION OF THE INVENTION

[0021] The specimen collection tool is a tool used to collect gingival crevicular fluid or peri-implant crevicular fluid. The specimen collection device has a flat-plate-shaped exudate collection portion, a grip portion for holding the exudate collection portion, and a flat-plate-shaped support portion.

[0022] The exudate collection portion is a flat plate made of a material capable of absorbing and retaining exudate, and has a roughly rectangular shape. The exudate collection portion has a grip portion near the long edge thereof.

[0023] The gripping portion is made of a hydrophobic material and is provided on both sides of the flat plate-like exudate collection portion, extending from the tip of the long side end of the approximately rectangular body toward the other long side end, but not extending beyond the center between the other long side end and the long side end.

[0024] The support part is made of a hydrophobic, elastic material and is approximately rectangular. The exudate collection part is removably attached to the long side end of the approximately rectangular body via a grip part, and the other long side end is an absorbent support end that supports the exudate absorption part.

[0025] The surfaces of the support portion and the exudate collection portion face each other and are adjacent to each other. The long side end of the exudate collection portion and the long side end of the approximately rectangular support portion are bonded together so that they are held in the same direction. Compared to the other long side end of the exudate collection portion, the other long side end of the approximately rectangular support portion protrudes toward the other end.

[0026] The shorter side of the approximately rectangular shape of the support part is 0.5 to 2.0 times, and preferably 0.7 to 1.5 times, the shorter side of the approximately rectangular shape of the exudate collection part. The tip of the other end of the long side of the support part protrudes 0 to 5.0 mm beyond the tip of the other end of the long side of the exudate collection part.

[0027] The overall configuration of the specimen collection device (10) according to the embodiment will now be described. As shown in Figure 1 or 2, the specimen collection device (10) has a flat, plate-shaped support portion (20), and is composed of a biological fluid collection portion (30) and a grip portion (40) that are held on the surface of the support portion (20) with adhesive (50).

[0028] As shown in FIG. 4, for example, the specimen collection tool of the present invention is configured such that the short side (20a) of the support portion is inserted into the gingival sulcus (80) of the target area formed in the gap between the natural tooth (60a) and the gum (70) and fixed in the vicinity, so that the gingival crevicular fluid (80a) can be reliably absorbed and collected by the biological fluid collection portion (30) without coming off. Furthermore, as shown in Figure 5, for example, by inserting the short side (20a) of the support part into the gingival sulcus (80) of the target area formed in the gap between the artificial tooth (60b) or implant body (90) and the gums (70) and fixing it nearby, the biological fluid collection part (30) can reliably absorb and collect the exudate (80b) around the implant sulcus without coming off.

[0029] It should be noted that there is no problem if the support portion (20) and the biological fluid collection portion (30) are inserted as a unit so that they overlap each other into the gingival sulcus (80) at the target site as shown in FIG. Furthermore, after specimen collection, the biological fluid collection section (30) can be separated from the support section (20) and used without getting in the way during the specimen extraction process.

[0030] A part of the surface of the support part (20) is coated with an adhesive (50), and the adhesive (50) can hold and detach the grip part (40).

[0031] The material of the support part (20) is not particularly limited as long as it is an elastic resin, and for example, resins such as polyethylene, polypropylene, polyethylene terephthalate, polybutylene terephthalate, polystyrene, polymethyl methacrylate, cellulose propionate, polyacrylate, polycarbonate, polyoxymethylene, acrylonitrile, polyamide, etc. can be used alone or in combination of two or more.

[0032] The biological fluid collection portion (30) is not particularly limited as long as it is made of a material that can absorb and retain biological fluids, and examples that can be used include paper, Japanese paper, pulp paper, cellulose used in filter paper, glass fiber, and nonwoven fabric fibers.

[0033] The grip portion (40) is not particularly limited as long as it is made of a hydrophobic material that does not easily absorb liquids such as water, and examples that can be used include polyvinyl alcohol, polyvinyl acetate, polyvinylpyrrolidone, butyral resin, etc. It is also preferable that the grip portion (40) is strong enough to be held with tweezers or the like.

[0034] The adhesive (50) is not particularly limited as long as it is a material that has the adhesive ability to hold the gripping portion (40) and can be released with the application of a small amount of force, and can be covered with, for example, an acrylic, urethane, vinyl acetate, silicone, fluorine-based, or other synthetic resin.

[0035] The support portion 20 is inserted into the gingival sulcus or peri-implant sulcus and serves to fix or maintain the specimen collection tool 10 in the vicinity. Therefore, the dimension (W1) of the short side (20a) of one end of the support portion 20 suitable for insertion into the gingival sulcus or peri-implant sulcus is preferably more than 0.5 times and not more than 2 times the dimension (W2) of the short side (30a) of the biological fluid collection portion 30, and more preferably more than 0.7 times and not more than 1.5 times the dimension (W2).

[0036] Similarly, the length (T1) of the support portion protrusion (20b) of the support portion (20) suitable for insertion into the gingival sulcus or the peri-implant sulcus is preferably 0 mm or more and 5 mm or less, more preferably 0.2 mm or more and 3 mm or less, protruding from the short side (30a) of the biological fluid collection portion. [Industrial Applicability]

[0037] The present invention is an instrument for collecting gingival crevicular fluid or peri-implant crevicular fluid, and can be used industrially.

Claims

1. A specimen collection device for collecting gingival crevicular fluid or peri-implant crevicular fluid, The device has a flat exudate collection part, a grip part for holding the exudate collection part, and a flat support part, the exudate collection portion is made of a material capable of absorbing and retaining exudate, is a substantially rectangular body, has a grip portion near one end of a long side of the substantially rectangular body, and the other end of the long side of the exudate collection portion is an exudate absorption end; The gripping portion is made of a hydrophobic material and is provided on both sides of the flat plate-like exudate collection portion, and extends from the tip of the long side end of the approximately rectangular body toward the other long side end, but does not extend beyond the center between the other long side end and the long side end. the support part is made of a hydrophobic elastic material and has a substantially rectangular shape, and the exudate collection part is detachably attached to a long side end of the substantially rectangular shape via a grip part; The surfaces of the support part and exudate collection part are opposite and close to each other, The long side end of the exudate collection part and the long side end of the approximately rectangular body of the support part are bonded together so as to be held in the same direction, A specimen collection device in which the other end of the long side of the approximately rectangular support part protrudes toward the other end compared to the other end of the long side of the exudate collection part.

2. The short side of the approximately rectangular shape of the support part is 0.5 to 2.0 times larger than the short side of the approximately rectangular shape of the exudate collection part, 2. The specimen collecting device according to claim 1, wherein the tip of the other long side end of the support portion protrudes from the tip of the other long side end of the exudate collecting portion by a length of 5.0 mm or less.

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