Biopsy cap and biopsy forceps comprising same

Abstract

The present invention relates to a biopsy cap that can be stably mounted on and dismounted from a forceps structure during biopsy. The cap comprises: a cap body which closely contacts the outer side in correspondence with a curved recess structure of the forceps member that is opened or closed by an external force; a curved support body supported on the inner side; and a connection body connecting the two. The support body is in curved-surface contact with the curved recess on the inner side of the forceps to increase positional stability, and the connection body is inserted into a spherical void, which is formed by engagement of semicircular recesses at the tip of the forceps, thereby ensuring secure engagement. The material of the cap is biocompatible, and the cap is configured to not cause damage to the gastric mucosa and the endoscope channel. In particular, the cap consists of a composite polymer material in a combination of PEEK, PU, TPE-S, PTFE, and the like, and maintains a surface friction coefficient at 0.2 or less, thus having excellent insertability and retrievability. This structure improves ease of attachment and detachment of the cap, specimen preservation, and procedural stability. Therefore, the present invention can greatly improve the precision and efficiency of endoscopic biopsy procedures.

Description

Biopsy cap and biopsy forceps including the same

[0001] The present invention relates to a specimen collection cap for biopsy forceps and a biopsy forceps including the same. More specifically, the invention relates to a biopsy cap and a biopsy forceps including the same that can simultaneously achieve a structure capable of collecting a specimen by rubbing, stable fixation and prevention of contamination after collection, and improved operational convenience for the operator.

[0002] Helicobacter pylori is generally known as a major causative agent of various gastrointestinal diseases, such as peptic ulcers, gastritis, and gastric cancer, and it is a very common infection in Korea, with an infection prevalence rate reaching approximately 50%. Given this high prevalence and the severity of related diseases, establishing accurate and safe diagnostic methods for H. pylori infection is clinically very important.

[0003] Currently, the rapid urease test (RUT) and biopsy are generally recommended endoscopic methods for diagnosing H. pylori infection. Among these, the RUT is a test in which a gastric mucosal tissue is biopsied via endoscopy and immersed in a urea substrate to confirm, through a color change, that the ammonia produced by the urease secreted by H. pylori raises the surrounding pH. This test is highly accurate, with reported sensitivity of 85 to 98% and specificity of 89 to 100%, and is considered a rapid, practical, and invasive test that can be easily performed during endoscopy.

[0004] However, since H. pylori is not uniformly distributed across the entire gastric mucosa, diagnosis using biopsy tissue carries the risk of false negatives depending on the collection site or sample size. In particular, in cases accompanied by atrophic gastritis or intestinal metaplasia, the mucosal environment is unfavorable for H. pylori survival, making detection difficult. Accordingly, it is recommended to collect at least two tissue samples from the antrum and at least two from the body of the stomach for accurate diagnosis. However, in actual clinical practice, tissue samples are often collected from only a single site due to increased testing time and costs, as well as the risk of bleeding. Furthermore, with the increase in the elderly population and the growing number of patients taking anticoagulants or antiplatelet agents for cardiovascular diseases, the implementation of invasive testing methods is sometimes restricted.

[0005] Accordingly, a safer and more accurate diagnostic method is required. Since H. pylori does not penetrate into gastric mucosal cells but rather resides within the mucus layer covering the mucosa and lives attached to the mucosal surface, if it is possible to collect and test only the H. pylori present on the surface without performing a deep biopsy of the gastric mucosa itself, sufficient diagnostic information can be obtained while reducing invasiveness. Performing the rapid urease test in this manner can serve as an alternative for rapidly and safely determining H. pylori infection while minimizing the risk of bleeding or complications.

[0006] Korean Registered Patent No. 10-2116515 proposed a biopsy brush and a biopsy catheter kit including the same, taking these points into consideration.

[0007] However, the aforementioned Korean registered patent No. 10-2116515 has technical limitations and problems in terms of the usage method, separation structure, and material characteristics of the biopsy brush.

[0008] Conventional biopsy brushes perform the procedure by repeatedly rubbing a biopsy area with arranged bristles against the surface of the gastric mucosa to collect specimens of pathogens present on the mucosal surface of the gastrointestinal tract, particularly Helicobacter pylori. While this method has the advantages of being relatively less invasive and having a lower risk of bleeding compared to the existing method of directly biopsying the gastric mucosa, it has the following structural and functional problems.

[0009] First, the method of simply rubbing a biopsy brush against the mucosal surface a few times presents a problem in that the quantity and quality of the collected specimen become inconsistent depending on the shape and compressive force of the brush bristles and the condition of the mucosa. In particular, it is difficult to effectively scrape away bacteria unevenly distributed within the mucus layer attached to the mucosa, and there is a possibility of false negatives occurring because the actual collected amount is negligible or no bacteria are attached. In other words, it suffers from the problem of non-uniformity due to the specimen collection method.

[0010] Furthermore, conventional biopsy catheter kits require mechanical manipulation, such as the use of forceps and an inner tube, to separate the brush from the collection container after the biopsy is completed; this process is somewhat inconvenient or unintuitive for inexperienced medical personnel. In particular, the operation to release the engagement between the forceps and the brush relies on the elastic restoring force of the forceps in conjunction with the insertion and withdrawal of the wire. Consequently, accurate separation movements may not be reproduced during repeated use, or the direction or orientation of the brush upon retrieval may be inconsistent, potentially leading to additional contamination. In short, the separation structure of the biopsy brush suffers from both unintuitiveness and procedural complexity.

[0011] Furthermore, conventional biopsy brushes utilize plate-shaped bristles to ensure vertical rigidity of the contact surface; however, even in this case, the contact area is limited, and since friction conditions between the mucosa and the mucous layer can vary, there is a possibility that the bristles may not sufficiently penetrate the mucous layer within the tissue. Additionally, the plate shape is prone to bending or wearing down with repeated use, making it difficult to maintain consistent collection performance, and it may fail to form an accurate elliptical shape when the biopsy site expands. In other words, there are limitations to collection depending on the material and shape of the bristles.

[0012] Furthermore, conventionally, brush bristles were made of materials such as metal wire or synthetic resin; however, considering the sensitivity of the gastric mucosa, there is still a risk of micro-surface damage or local bleeding due to friction upon repeated contact. In particular, metal brush bristles can cause damage to the inner wall of the endoscope or introduce foreign substances into the collected bacteria, which may affect diagnostic accuracy. In other words, the brush material has issues regarding biocompatibility and washability.

[0013] In other words, conventional biopsy brushes are designed to collect pathogens by repeatedly rubbing the surface of the gastric mucosa during gastroscopy; however, there is a problem with the inability to securely collect specimens due to limitations in the shape and material of the brush bristles. In particular, since pathogens such as Helicobacter pylori are confined to the mucous layer of the gastric mucosa, diagnostic accuracy may be reduced if the brush bristles fail to sufficiently penetrate the mucous layer, and the absence of a specimen may lead to a false-negative result.

[0014] Furthermore, according to conventional technology, biopsy brushes are connected to forceps using an integrated or simple insertion fixation method. This necessitates separate, complex operations to detach the brush collected after the procedure, and there are issues with the reliability of the connection between the forceps and the brush. Consequently, it is difficult to retrieve the biopsy brush quickly and without contamination into the collection container immediately after the procedure, leading to limitations that reduce practical diagnostic efficiency.

[0015] Furthermore, while the brush bristles in contact with the mucous membrane must effectively collect the specimen through repeated contact and friction, conventional brush bristles are formed in the shape of plates or circular wires, which limits the surface area for friction with the mucus layer and may reduce specimen collection efficiency. Accordingly, it is also essential to apply materials with optimized surface characteristics to ensure stable adhesion of the specimen to the brush bristles.

[0016] Accordingly, there is a demand for the development of a material that allows specimens to be collected stably despite the method of repeatedly rubbing the surface of the gastric mucosa, forms a fastening structure that enables stable attachment and detachment by a pair of forceps after the biopsy procedure, allows the biopsy brush to be quickly and accurately separated from the catheter and directly inserted into a collection container without cross-infection or contamination upon retrieval, and enables specimens within the mucosa to be effectively adhered to the brush bristles by the rubbing motion.

[0017] The present invention has been devised to solve the aforementioned problems, and the objectives of the present invention are as follows.

[0018] The present invention relates to a biopsy forceps and a biopsy cap attached thereto, which are applied to gastroscopes or other biopsy procedure equipment. In particular, the main objective is to provide a structure capable of simultaneously achieving specimen collection by rubbing, stable fixation and prevention of contamination after collection, and improved operational convenience for the operator.

[0019] Specifically, the following objectives are to be achieved by providing a biopsy cap configured to be accurately mounted on a pair of forceps members, wherein a curved groove is formed on the inner side of the pair of forceps members that open or close by an external force.

[0020] First, when collecting a specimen, the biopsy cap is stably attached to the forceps component so that it remains stable without shaking during the procedure, thereby preventing the loss or contamination of the collected tissue or pathogens.

[0021] Second, after the procedure is completed, the biopsy cap is automatically released with just a simple opening and closing motion of the forceps, allowing it to be easily retrieved into the collection container, thereby reducing the operational burden on medical staff and improving the efficiency of the procedure.

[0022] Third, by designing the connecting body to self-align and accurately fasten in conjunction with the semicircular groove structure formed at the tip of the forceps member, structural consistency and positional repeatability are ensured, and consistent operability and precision are secured even during repeated use.

[0023] Fourth, by implementing the support body of the biopsy cap as a plate or sphere with a curvature, the adhesion force with the inner curved surface of the forceps is maximized, and versatility and design flexibility are provided to flexibly respond to various forceps designs.

[0024] Through these objectives, the present invention is significant in that it effectively solves problems such as fixation instability, operational complexity, specimen loss, and contamination that occurred in conventional biopsy brush and forceps structures, and provides a technology capable of realizing a more reliable and hygienic biopsy procedure environment.

[0025] The objects of the present invention are not limited to those mentioned above, and other unmentioned objects and advantages of the present invention may be understood from the following description and will be more clearly understood by the embodiments of the present invention. Furthermore, it will be readily apparent that the objects and advantages of the present invention can be realized by the means and combinations thereof set forth in the claims.

[0026] To achieve the above objectives, the present invention provides a biopsy cap that is detachably attached to a pair of forceps members, the inner surfaces of which are cross-driven to open or close by an external force and which have curved grooves.

[0027] The biopsy cap comprises a cap body that adheres to the outer surface of the outer circumference of the pair of closed forceps members, a support body that is supported on the inner side of the pair of closed forceps members, and a connecting body that penetrates the pair of closed forceps members and connects the cap body and the support body.

[0028] Here, the support body is,

[0029] It is desirable that the curved surface contact be made in a portion of the curved groove of the aforementioned pair of clamp members.

[0030] In addition, the support body is preferably formed as a plate-shaped body with curvature or a spherical body.

[0031] In addition, a semicircular groove is formed by cutting into the tip of each of the pair of forceps members, and

[0032] When the above pair of clamp members are closed, each of the above semicircular grooves comes into contact with each other to form a spherical groove, and

[0033] The above connecting body is,

[0034] It is preferable that it be positioned to be fitted into the above-mentioned spherical groove.

[0035] In addition, the biopsy cap comprises 60% to 70% by weight of polyetheretherketone (PEEK), 10% to 15% by weight of polyurethane (PU), 5% to 10% by weight of polytetrafluoroethylene (PTFE), 1% to 3% by weight of titanium dioxide (TiO2), and 10% to 15% by weight of silicone-based thermoplastic elastomer (TPE-S).

[0036] Here, the outer surface of the cap body is coated with polytetrafluoroethylene (PTFE), and the PTFE coating layer has a thickness of 5 μm or more and 30 μm or less, and is treated so that the coefficient of friction (COF) is maintained at 0.2 or less.

[0037]

[0038] According to another embodiment, the present invention provides a biopsy forceps.

[0039] The biopsy forceps described above comprises: a head portion having a pair of forceps members that are cross-driven to open or close by an external force and whose inner surfaces are formed as curved grooves; and a cap detachably mounted on the tip of the closed pair of forceps members.

[0040] The above cap includes a cap body that is in close contact with the outer circumference of the pair of clamping forceps members, a support body that is supported on the inner side of the pair of clamping forceps members, and a connecting body that penetrates the pair of clamping forceps members and connects the cap body and the support body.

[0041] Here, the support body is,

[0042] It is desirable that the curved surface contact be made in a portion of the curved groove of the aforementioned pair of clamp members.

[0043] And, the support body is formed as a plate-shaped body with a curvature or a spherical body, and

[0044] At the tips of the above pair of pliers members, a semicircular groove is cut and formed in each, and

[0045] When the above pair of clamp members are closed, each of the above semicircular grooves comes into contact with each other to form a spherical groove, and

[0046] The above connecting body is,

[0047] It is preferable that it be positioned to be fitted into the above-mentioned spherical groove.

[0048] According to the present invention, through the means for solving the above problem, a curved groove is formed on the inner surface of a pair of forceps members that are cross-driven to open or close by an external force, and a biopsy cap is attached to the forceps members in a detachable structure, thereby effectively improving the specimen fixation force and procedural stability during the biopsy process.

[0049] In particular, the biopsy cap according to the present invention comprises a cap body that adheres to the outer circumference of a forceps member, a support body that provides support by making curved contact with a portion of a curved groove, and a connecting body that connects the two. Consequently, self-aligning mounting and dismounting are possible, in which the cap is automatically fixed as the forceps close and naturally detached as they open. Accordingly, the biopsy cap is stably mounted on the forceps member without the need for a separate fastening member, allowing the specimen to be accurately maintained without shaking or detachment during the procedure.

[0050] Furthermore, the present invention is designed such that semicircular grooves formed at the tip of a forceps member form spherical grooves as the forceps member contracts, and a connecting body is inserted into these grooves, thereby ensuring that the biopsy cap is precisely fastened to the tip of the forceps member while maintaining positional accuracy. This ensures structural stability even during repeated biopsy processes and minimizes contamination or loss of the cap to which tissue or pathogens are attached during biopsy.

[0051] In addition, the support body is provided in a plate-like or spherical shape with a curvature, allowing it to flexibly adapt to the shape of the inner curved groove of the forceps, making it applicable to various forceps structures; at the same time, it is expected to reduce friction and distribute mechanical stress during the insertion and retrieval processes within the body.

[0052] Consequently, the present invention provides a technical effect that reduces the operational burden on the operator and simultaneously ensures the accuracy of specimen collection and procedural hygiene by automating and refining the entire process of mounting, fixing, and releasing the biopsy cap. This serves as an effective means to substantially improve the structural problems of existing biopsy instruments and enhance the quality of endoscopy-based biopsy procedures.

[0053] In addition to the effects described above, the specific effects of the present invention are described together with the specific details for implementing the invention below.

[0054] FIG. 1 is a drawing showing a biopsy forceps equipped with a biopsy cap according to the present invention.

[0055] [Correction pursuant to Rule 91 16.04.2026] Fig. 2a is a diagram showing the configuration of the head portion of the biopsy forceps of Fig. 1.

[0056] FIG. 2b is a cross-sectional view showing a biopsy forceps equipped with a biopsy cap according to the present invention.

[0057] FIG. 3 is a perspective view showing a first embodiment of a biopsy cap according to the present invention.

[0058] Figure 4 is a cross-sectional view showing a biopsy cap along line AA of Figure 3.

[0059] FIGS. 5 to 7 are drawings showing the process of mounting a biopsy cap according to the present invention onto a pair of forceps members.

[0060] FIG. 8 is a perspective view showing a second embodiment of a biopsy cap according to the present invention. FIG. 9 is a cross-sectional view showing a biopsy cap along line BB of FIG. 8.

[0061] FIGS. 10 to 12 are drawings showing the process of mounting a biopsy cap according to the present invention onto a pair of forceps members.

[0062] FIG. 13 is a table showing Examples 1 and 2 and Comparative Examples 1 and 2.

[0063] Figure 14 is a graph showing the results of comparing the composition ratios and surface friction coefficients (COF) of biopsy caps in Examples 1 and 2 and Comparative Examples 1 and 2.

[0064] Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings so that those skilled in the art can easily implement the present invention.

[0065] The present invention may be implemented in various different forms and is not limited to the embodiments described herein.

[0066] To clearly explain the present invention, parts unrelated to the explanation have been omitted, and the same reference numerals are used for identical or similar components throughout the specification.

[0067] In the following description, the statement that any configuration is provided or arranged on the "upper (or lower) surface" or the "upper (or lower) surface" of the description means that any configuration is provided or arranged in contact with the upper (or lower) surface of the description.

[0068] Furthermore, it is not limited to including any other configuration between the above description and any configuration provided or placed on (or under) the description.

[0069] The following describes the biopsy cap and the biopsy forceps having the same according to the present invention with reference to the attached drawings.

[0070] FIG. 1 is a drawing showing a biopsy forceps equipped with a biopsy cap according to the present invention.

[0071] FIG. 2a is a diagram showing the configuration of the head portion of the biopsy forceps of FIG. 1. FIG. 2b is a cross-sectional view showing a biopsy forceps equipped with a biopsy cap according to the present invention.

[0072] The biopsy cap according to the present invention may be included in the composition of the biopsy forceps.

[0073] Referring to FIGS. 1 to 2b, the biopsy forceps (1) according to the present invention has a head portion (10). An inlet (11) is formed at the rear end of the head portion (10) to receive the end of a wire (20).

[0074] The head portion according to the present invention may be configured as a jaw or a cup.

[0075] A space is formed inside the head portion (10). Links (30) are arranged in the space.

[0076] The front and both sides of the head portion (10) are cut to form an exposed hole (12).

[0077] A pair of forceps members (40) are disposed at the front end of the head portion (10).

[0078] Here, the pair of forceps members (40) are composed of first and second forceps members (41, 42) arranged to face each other.

[0079] A first-1 link (31a) is connected to the rear end of the first forceps member (41), and a second-1 link (32a) is connected to the rear end of the second forceps member (42).

[0080] The first link (31a) and the second link (32a) are arranged to intersect each other, and the intersecting portion is rotatably supported by a first hinge (H1) formed at the front end of the head portion (10).

[0081] And, a first-2 link (31b) is hinge-connected to the rear end of the first-1 link (31a), and a second-2 link (32b) is hinge-connected to the rear end of the second-1 link (32a).

[0082] Additionally, the rear end of the first-2 link (31b) and the rear end of the second-2 link (32b) can be connected together through the end of the wire (20) and the second hinge (H2).

[0083] Here, the links (30) can be exposed to the outside through the exposure hole (12).

[0084] The above wire (20) can be pushed or pulled by an external force.

[0085] Accordingly, the 1-1 link (31a) and the 1-2 link (31b) can rotate, and the 2-1 link (32a) and the 2-2 link (32b) on the opposite side can also rotate simultaneously.

[0086] By this operation, the first and second forceps members (41, 42) may be able to move inward or outward.

[0087] Here, the first and second forceps members (41, 42) according to the present invention have a certain length, a curved groove (40a) is formed on the inner side, and the front portion can form a rounded outer surface.

[0088] The inner surfaces of the first and second forceps members (41, 42) form straight surfaces and are arranged to face each other.

[0089] Accordingly, when the first and second forceps members (41, 42) are closed, the inner surfaces of the first and second forceps members (41, 42) form a structure that comes into contact with each other.

[0090] Meanwhile, a semicircular groove (40b) is formed at the front end of each of the first and second forceps members (41, 42).

[0091] Accordingly, when the first and second forceps members (41, 42) are brought together and come into contact with each other, the respective semicircular grooves (40b) can be formed into circular grooves. Of course, although the semicircular groove (40b) has been described as a representative example in the present invention, a polygonal groove (not shown) may also be formed.

[0092] Accordingly, when the first and second forceps members (41, 42) are closed, an internal space is formed on the inner side through the curved groove (40a), and this internal space is exposed to the outside through the circular groove, and the shear outer surface of the first and second forceps members (41, 42) forms an area that forms a rounded surface with a curve.

[0093] The biopsy cap according to the present invention is mounted to be fixed to the front end of the first and second forceps members that are closed.

[0094] Of course, although the above-mentioned forceps have been described as a representative example in the present invention, the invention is not limited to the above-mentioned forceps and may be another medical device having a configuration that closes or opens up to each other like the above-mentioned first and second forceps members, having a semicircular groove formed at each front end, and when the first and second forceps members close up to each other and come into contact, one semicircular groove comes into contact to form a circular groove, and the front end circumference of the first and second forceps members is formed in a round shape.

[0095]

[0096] FIG. 3 is a perspective view showing a first embodiment of a biopsy cap according to the present invention. FIG. 4 is a cross-sectional view showing a biopsy cap along line AA of FIG. 3.

[0097] Referring to FIGS. 3 and 4, a biopsy cap (2) according to the present invention will be described.

[0098] The biopsy cap (2) according to the present invention is detachably mounted on the closed first and second forceps members (41, 42).

[0099] A biopsy cap (2) according to the present invention comprises a cap body (210) that is in close contact with the outer surface of the outer circumference of the pair of clamping forceps members (40), a support body (220) that is supported on the inner side of the pair of clamping forceps members (40), and a connecting body (230) that penetrates the pair of clamping forceps members (40) and connects the cap body (210) and the support body (220).

[0100] Here, the support body (220) is positioned on the inner side of the closed pair of forceps members and makes curved contact with a portion of the curved groove (40a) formed by being concave on the inner side of the pair of forceps members.

[0101] And, the support body (220) is formed as a plate-shaped body with a curvature.

[0102] Additionally, the connecting body (230) is positioned to be fitted into the spherical groove formed by a pair of semicircular grooves (40b) coming into contact.

[0103] FIGS. 5 to 7 are drawings showing the process of mounting a biopsy cap according to the present invention onto a pair of forceps members.

[0104] Referring to FIGS. 5 to 7, as described with reference to FIGS. 1 and 2, when the first and second pliers members (41, 42) are spread apart, if the wire (20) is retracted through an external force, the first and second pliers members (41, 42) can be rotated in opposite directions and closed together.

[0105] Accordingly, with the first and second forceps members (41, 42) spread apart from each other, the support body (220) of the biopsy cap (2) is positioned in the inner space of the first forceps member (41).

[0106] At this time, the connecting body (230) connected to the supporting body (220) can be fitted into and hung in the semicircular groove (40b) formed at the front end of the first forceps member (41).

[0107] At the same time, the cap body (210) connected to the end of the connecting body (230) can be contacted to wrap around the front circumference of the first forceps member (41).

[0108] Next, when the wire (20) moves backward in accordance with the application of external force, the second forceps member (42) can rotate in a cross direction and come into contact with the inner surface of the first forceps member (41).

[0109] At this time, the inner wall of the inner space of the first and second pliers members (41, 42) that are closed together forms a curved groove (40a), and a pair of semicircular grooves (40b) formed at the front of the first and second pliers members (41, 42) come into contact with each other to form a circular groove.

[0110] Accordingly, the support body (220) is positioned in the inner space of the first and second forceps members (41, 42), the connecting body (230) is fitted into a circular groove, and the cap body (210) can be fixed to wrap around the front circumference of the first and second forceps members (41, 42).

[0111] Here, the support body (220) is formed in a disc shape and forms a structure that is in close contact with and caught on the inner wall of the curved groove (40a) on the circumference of the circular groove, the connecting body (230) forms a structure that is fitted into and caught in the circular groove, and the cap body (210) forms a structure that is in close contact with and wraps around the front circumference of the first and second pliers members (41, 42).

[0112] With reference to this, the biopsy cap of the present invention is a structure designed to be stably mounted on the tip of a biopsy forceps to simultaneously prevent detachment and protect tissue during specimen collection or retrieval, and provides the following functions and effects.

[0113] A biopsy cap according to the present invention comprises a cap body that surrounds the outer side, a support body that is supported in an inner curved groove, and a connecting body that connects the two, corresponding to a pair of forceps members that rotate in a constricted manner. This structure enables the biopsy cap to be automatically fastened and unfastened in conjunction with the opening and closing movements of the forceps, thereby allowing for rapid and accurate operation while minimizing the operational burden on the operator.

[0114] During operation, the support body makes curved contact with a portion of the curved groove formed on the inner side of the forceps, and the connecting body is inserted into a spherical groove formed by the abutment of semicircular grooves formed on the tip of the forceps. Accordingly, the biopsy cap can simultaneously secure positional alignment and fixation through multi-curved contact with the inner wall of the forceps. Since the outer surface of the tip of the forceps is rounded and the cap body is structured to wrap around it, it is possible to ensure gentle contact with biological tissue while minimizing mucosal damage during insertion.

[0115] Furthermore, the biopsy cap of the present invention forms a mechanical structure in which the cap is automatically secured by closing the forceps via a wire after mounting, and conversely, the cap is naturally detached through an opening motion, allowing it to be transferred directly to a retrieval container. This action reduces the risk of specimen contamination during the biopsy process and provides a hygienic and efficient structure that enables retrieval without additional tools.

[0116] As a result, the biopsy cap of the present invention actively utilizes the structural movement characteristics of the forceps to simultaneously satisfy functions such as precise fixation, easy attachment and detachment, stable contact with the gastric mucosa, and minimization of damage to the endoscope channel and tissue, thereby realizing a technical effect that can dramatically improve the precision, maneuverability, and safety of the biopsy procedure.

[0117] FIG. 8 is a perspective view showing a second embodiment of a biopsy cap according to the present invention. FIG. 9 is a cross-sectional view showing a biopsy cap along line BB of FIG. 8.

[0118] Referring to FIGS. 8 and 9, a second embodiment of the biopsy cap of the present invention may be substantially similar to the configuration of the first embodiment.

[0119] That is, the second embodiment of the biopsy cap (2) of the present invention has a cap body (210), a support body (220'), and a connecting body (230).

[0120] Here, the support body (220') is formed in a spherical shape.

[0121] The volume of the support body (220') forming the above-described spherical shape can be formed to be smaller than the volume of the curved groove (40a) formed by the contact of the pair of semicircular grooves (40b) described above.

[0122] Accordingly, when a spherical supporting body (220') is positioned in the inner space of a pair of clamp members (40), the volume of the inner space can be formed to be larger than the volume of the supporting body (220').

[0123] FIGS. 10 to 12 are drawings showing the process of mounting a biopsy cap according to the present invention onto a pair of forceps members.

[0124] Referring to FIGS. 10 to 12, as described with reference to FIGS. 1 and 2, when the first and second forceps members (41, 42) are spread apart from each other, and the wire (20) is retracted through an external force, the first and second forceps members (41, 42) can be rotated in opposite directions and closed together.

[0125] Accordingly, with the first and second forceps members (41, 42) spread apart from each other, the support body (220') of the biopsy cap (2) is positioned in the inner space of the first forceps member (41).

[0126] At this time, the connecting body (230) connected to the supporting body (220') can be fitted into and hung in the semicircular groove (40b) formed at the front end of the first forceps member (41).

[0127] At the same time, the cap body (210) connected to the end of the connecting body (230) can be in contact with the front circumference of the first forceps member (41).

[0128] Next, when the wire (20) moves backward in accordance with the application of external force, the second forceps member (42) can rotate in a cross direction and come into contact with the inner surface of the first forceps member (41).

[0129] At this time, the inner wall of the inner space of the first and second pliers members (41, 42) that are closed together forms a curved groove (40a), and a pair of semicircular grooves (40b) formed at the front of the first and second pliers members (41, 42) come into contact with each other to form a circular groove.

[0130] Accordingly, the spherical supporting body (220') is positioned in the inner space of the first and second pliers members (41, 42), the connecting body (230) is fitted into a circular groove, and the cap body can be fixed to wrap around the front circumference of the first and second pliers members (41, 42).

[0131] Here, the support body (220') is formed in a spherical shape and forms a structure that is in close contact with the inner wall of the curved groove (40a) around the circular groove, and the connecting body (230) forms a structure that is fitted into the circular groove and is caught, and the cap body (210) forms a structure that wraps around the front circumference of the first and second forceps members (41, 42) and is in close contact.

[0132] The support body (220') of the second embodiment of the biopsy cap (2) according to the present invention has a spherical shape, and as it has a volume smaller than the inner space of the first and second forceps members (41, 42), the inner space may have a free space.

[0133] Referring to this, the biopsy cap (2) according to the second embodiment of the present invention maintains a structural configuration similar to that of the first embodiment, but forms the support body (220') in a spherical shape and designs its volume to be smaller than the inner space of the forceps, thereby providing the following differentiated action and effect in terms of structural and functional aspects.

[0134] First, since the support body (220') is formed in a spherical shape, the stability of the curved contact with the inner curved groove (40a) of the forceps member is improved. Multi-faceted contact is made along the curvature, and uniform pressure distribution is possible when in close contact with the inner wall of the forceps, thereby preventing shaking or displacement during the procedure.

[0135] In addition, as the volume of the spherical support body is formed to be smaller than the inner space of the forceps, a certain clearance is secured on the inner side. This clearance induces the following practical effects.

[0136] In addition, flexibility in the mounting process can be ensured. The spherical support body can be inserted more easily into the inner space before the forceps member is closed, and it is less affected by the opening and closing angle of the forceps.

[0137] Furthermore, error tolerance and compliance with manufacturing tolerances can be improved. Assembly reliability is enhanced by providing a self-aligning effect for minor positional errors, manufacturing tolerances, and press-fit angle errors that may occur during actual use.

[0138] It can mitigate vibrations and micro-shocks during endoscopic procedures. Allowing for slight micro-movement within the available space, it acts as a buffer against minute vibrations or pressure changes that may occur during the procedure, and reduces friction between the forceps and the mucosa.

[0139] It also offers ease of release. During the process of the forceps spreading, the spherical support body can detach relatively smoothly within the inner space, reducing jamming during retrieval and improving the efficiency of the post-procedure processing stage.

[0140] In conclusion, the biopsy cap according to the second embodiment of the present invention can improve ease of assembly, contact stability, vibration damping, and retrieval after the procedure through a spherical shape and small volume design, and enables the realization of a high-performance biopsy cap that flexibly responds to the mechanical properties of the forceps structure. This can provide a substantial effect of simultaneously improving the safety of the medical device and the operational efficiency of the operator.

[0141]

[0142] The following describes the material of the biopsy cap according to the present invention.

[0143] FIG. 13 is a table showing Examples 1 and 2 and Comparative Examples 1 and 2.

[0144] The composition ratio of the biopsy cap according to the present invention is described.

[0145] The biopsy cap according to the present invention may comprise 60% to 70% by weight of polyetheretherketone (PEEK), 10% to 15% by weight of polyurethane (PU), 5% to 10% by weight of polytetrafluoroethylene (PTFE), 1% to 3% by weight of titanium dioxide (TiO2), and 10% to 15% by weight of silicone-based thermoplastic elastomer (TPE-S).

[0146] Here, the outer surface of the cap body is coated with polytetrafluoroethylene (PTFE), and the PTFE coating layer has a thickness of 5 μm or more and 30 μm or less, and is treated so that the coefficient of friction (COF) is maintained at 0.2 or less.

[0147] The composition ratio of the biopsy cap according to the present invention may be based on a combination of polymer composite materials optimized to simultaneously satisfy mechanical strength, biocompatibility, ease of insertion, and tissue protection required in a biopsy procedure environment.

[0148] First, by including polyetheretherketone (PEEK) in an amount of 60% to 70% by weight as a main component to ensure the overall structural stability of the cap, high strength and high heat resistance properties are imparted, and stable fixation without structural deformation is possible when combined with endoscope forceps.

[0149] In addition, 10% to 15% by weight of polyurethane (PU) is added to complement flexibility and shock absorption capabilities, and 10% to 15% by weight of silicone-based thermoplastic elastomer (TPE-S) is included to enable conformity to curved structures and soft elastic action upon contact with mucous membranes.

[0150] In addition, polytetrafluoroethylene (PTFE) is included in an amount of 5% to 10% by weight, and the outer surface is coated with a thickness of 5μm or more and 30μm or less, thereby significantly reducing frictional resistance when the cap is inserted into and retrieved from the body.

[0151] As a result, the coefficient of friction (COF) can be maintained at 0.2 or less, which is very effective in preventing wear of the endoscope channel and improving operability for the operator. A small amount of titanium dioxide (TiO2) is included in an amount of 1% to 3% by weight to improve antibacterial and anti-contamination properties, and material stability can be maintained during long-term use.

[0152] This combination of materials allows the biopsy cap to be securely fastened inside the forceps, while ensuring that the tissue is not damaged even when in contact with the gastric or intestinal mucosa during the procedure, and allowing for smooth operation without frictional resistance during insertion and removal, thereby providing the effect of significantly improving the precision and safety of the biopsy procedure.

[0153] The following describes embodiments and comparative examples according to the present invention.

[0154] [Example 1]

[0155] Example 1 corresponds to the most ideal compositional example of a biopsy cap according to the present invention. Polyetheretherketone (PEEK), which possesses high strength and biocompatibility, was used for 65% of the total weight, ensuring mechanical support and stability of the entire cap structure. In addition, 10% polyurethane (PU) for elasticity and shock absorption and 15% silicone-based thermoplastic elastomer (TPE-S), which adheres to the curved groove of the forceps and can absorb shock during endoscope insertion, were included. Furthermore, a polytetrafluoroethylene (PTFE) coating with a thickness of 10 μm was applied to the outer surface, thereby maintaining a coefficient of friction (COF) of 0.17, resulting in almost no frictional resistance during insertion and preventing damage to the gastric mucosa and endoscope channel. This composition satisfies both structural compatibility and insertability, ensuring that the cap is accurately mounted within the forceps and can be reliably retrieved after the procedure.

[0156] [Example 2]

[0157] Example 2 is an example in which the PTFE coating is omitted, but it is designed to maintain low-friction characteristics through the combination of materials. The composition consists of 60% TPE-S, 5% PU, 10% PEEK microparticles, and 5% TiO2, forming a high-elasticity hybrid structure centered on flexibility and elasticity. In particular, due to the high-ratio combination of TPE-S and PU, the cap smoothly conforms to the curved shape of the forceps and minimizes irritation upon contact with the mucous membrane. The inclusion of a small amount of PEEK provides the rigidity necessary to maintain the structure, while TiO2 contributes to improved antibacterial properties and stability. Even in the uncoated state, the surface friction coefficient was measured at 0.19, demonstrating sufficient lubrication and resistance reduction effects during insertion and retraction. This example offers high economic efficiency and flexibility of application in that it can maintain substantial procedural performance without using PTFE.

[0158] [Comparative Example 1]

[0159] Comparative Example 1 is an example in which the composition ratio falls outside the technical scope of the present invention, containing an excessive amount of TPE-S up to 80% by weight, and containing only 5% and 10% of PEEK and PU, respectively. This results in an excessively high flexibility of the entire cap, making it difficult to maintain the structure within the forceps during the procedure, and causing problems such as easy twisting or deformation due to pressure during insertion. Furthermore, the complete absence of PTFE leads to reduced surface lubricity, and consequently, the surface friction coefficient rises to 0.25. This increases frictional resistance when passing through the endoscope channel and mucosa, raising the difficulty of manipulation for the operator and carrying the potential for damage to the mucosa. Therefore, this comparative example serves as a counterexample demonstrating that a design based on a highly flexible single material can reduce procedural suitability.

[0160] [Comparative Example 2]

[0161] Comparative Example 2 is a composition containing up to 85% PEEK to secure high-strength mechanical support, with TPE-S and PU each set at 5%. Although this composition appears sturdy, in reality, due to a lack of flexibility and elasticity, it fails to structurally conform to the curved groove of the forceps, making it difficult to achieve an accurate seal when attaching the cap. In particular, the excessive proportion of PEEK causes the cap to harden, which can lead to irritation upon contact with the gastric mucosa and increase resistance to passage when inserting the endoscope channel. Since PTFE is also not included, the total surface friction coefficient is measured at 0.26, exceeding the standard value of the present invention. This comparative example serves as a case demonstrating that an overly rigid design can actually be disadvantageous for in vivo applications.

[0162] Examples 1 and 2 demonstrate excellent results in terms of mechanical strength, biocompatibility, ease of procedure, and friction resistance control through the balance of composition. On the other hand, Comparative Example 1 and Comparative Example 2 clearly reveal structural instability and limitations in biocompatibility caused by excessive flexibility or excessive stiffness, respectively, which can empirically support the superiority of the composition and effects of the present invention.

[0163] Figure 14 is a graph showing the results of comparing the composition ratios and surface friction coefficients (COF) of biopsy caps in Examples 1 and 2 and Comparative Examples 1 and 2.

[0164] Referring to Figure 14, the left Y-axis shows the composition ratio, and the weight ratios of PEEK, PU, ​​TPE-S, PTFE, and TiO2 are shown in the form of stacked bars.

[0165] Example 1 has a very stable compositional balance and maintains the lowest friction coefficient by including PTFE.

[0166] Example 2 does not contain PTFE, but maintains a low coefficient of friction with a combination of TPE-S and PU.

[0167] Comparative Example 1 has an excessively high TPE-S and excessively high structural elasticity, making it vulnerable to fixation.

[0168] Comparative Example 2 has an excessively high specific gravity of PEEK, making it too hard and lacking flexibility.

[0169] Also, the right Y-axis shows the COF, and the dotted line represents the COF value of each composition.

[0170] In the present invention, the target standard is 0.2 or less, and Example 1 (0.17) and Example 2 (0.19) satisfy the standard.

[0171] Comparative Example 1 (0.25) and Comparative Example 2 (0.26) show that the friction coefficient is high, which indicates poor suitability for the procedure.

[0172] In conclusion, the biopsy cap of the present invention can secure structural stability by using PEEK, which has high strength and biocompatibility, as the main component.

[0173] The combined use of PU and TPE-S can provide soft elastic action and shock absorption effects upon contact with mucous membranes.

[0174] By including PTFE or using a combination of TPE-based materials, the coefficient of friction (COF) of the outer surface of the cap can be maintained at 0.2 or less.

[0175] Reduced friction prevents damage to the endoscope channel and mucosa, and improves maneuverability during insertion and retrieval.

[0176] The inclusion of TiO2 provides antibacterial properties and material stability, ensuring hygiene during procedures and long-term stability.

[0177] Example 1 achieves a COF of 0.17 through the balance of constituent materials and the application of a PTFE coating, exhibiting the most ideal performance.

[0178] Example 2 satisfies the standard with a COF of 0.19 despite not containing PTFE, and is advantageous in terms of economic efficiency and manufacturing flexibility.

[0179] On the other hand, Comparative Example 1 shows fixation instability and a high COF (0.25) due to excessive use of TPE-S.

[0180] Comparative Example 2 is hardened due to excessive use of PEEK, has a high possibility of mucosal damage, and has a COF of 0.26.

[0181] Consequently, the composition ratio of the present invention can achieve an optimal balance that satisfies mechanical strength, flexibility, insertability, and tissue protection.

[0182] The present invention is not limited to the specific preferred embodiments described above, and anyone with ordinary knowledge in the art to which the invention pertains can make various modifications without departing from the essence of the invention as claimed in the claims, and such modifications will be within the scope of the claims.

[0183] 1 : Tweezers

[0184] 10: Head section

[0185] 11 : Inlet

[0186] 12 : Exposed hole

[0187] 20 : Wire

[0188] 30 : Link

[0189] 31a : 1-1 link

[0190] 31b : 1st-2nd link

[0191] 32a : 2-1 link

[0192] 32b : 2-2 link

[0193] 40 : Forceps missing

[0194] 40a : Curved groove

[0195] 40b: Semicircular groove

[0196] 41: Absence of the first forceps

[0197] 42: Absence of the second forceps

[0198] 2 : Biopsy cap

[0199] 210 : Cap body

[0200] 220, 220' : Support body

[0201] 230 : Connecting body

Claims

1. A biopsy cap that is detachably attached to a pair of forceps members, the inner surface of which is driven to open or close by an external force and which is formed as a curved groove, The above biopsy cap is, A cap body that is in close contact with the outer circumference of the aforementioned pair of clamp members, and A support body supported on the inner side of the aforementioned pair of clamp members that are closed, and Characterized by including a connecting body that connects the cap body and the support body by penetrating the aforementioned pair of clamp members that are closed. Biopsy cap.

2. In Paragraph 1, The above-mentioned support body is, Characterized by making curved contact with a portion of the curved groove of the aforementioned pair of clamp members. Biopsy cap.

3. In Paragraph 2, The above-mentioned support body is characterized by being formed as a plate-shaped body with a formed curvature or a spherical body. Biopsy cap.

4. In Paragraph 1, At the tips of the above pair of forceps members, a semicircular groove is cut and formed in each, and When the above pair of clamp members are closed, each of the above semicircular grooves comes into contact with each other to form a spherical groove, and The above connecting body is, Characterized by being positioned to be fitted into the above-mentioned spherical groove, Biopsy cap.

5. A head portion having a pair of clamp members that are driven to open or close by an external force, and whose inner surface is formed as a curved groove; It includes a cap detachably mounted on the tip of the aforementioned pair of clamp members, The above cap is, A cap body that is in close contact with the outer circumference of the aforementioned pair of clamp members, and A support body supported on the inner side of the aforementioned pair of clamp members that are closed, and Characterized by including a connecting body that connects the cap body and the support body by penetrating the aforementioned pair of clamp members that are closed. Biopsy forceps.

6. In Paragraph 5, The above-mentioned support body is, Characterized by making curved contact with a portion of the curved groove of the aforementioned pair of clamp members. Biopsy forceps.

7. In Paragraph 6, The above-mentioned support body is formed as a plate-shaped body with a curvature or a spherical body, and At the tips of the above pair of forceps members, a semicircular groove is cut and formed in each, and When the above pair of clamp members are closed, each of the above semicircular grooves comes into contact with each other to form a spherical groove, and The above connecting body is, Characterized by being positioned to be fitted into the above-mentioned spherical groove, Biopsy forceps.

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