Endometrial sampler

Abstract

The invention discloses an endometrium sampler, which relates to the technical field of medical instruments and is technically characterized by comprising a protective sleeve, a movable tube, a brush rod, a top bead, bristles and a handle, the protective sleeve and the movable pipe are both of a hollow tubular structure, and the movable pipe is arranged in the protective sleeve and can move in the axial direction of the protective sleeve. The brush rod is arranged in the movable pipe, one end of the brush rod is fixedly connected with the handle, and the other end of the brush rod is fixedly connected with the top bead. The section, close to the top bead, of the brush rod is a brush rod front end; the bristles are attached to the front end of the brush rod and incline towards the top bead, and the top bead is of a semi-surrounding cover-shaped structure. During sampling operation, the handle is rotated to drive the front end of the brush rod to rotate, so that the bristles cover an inverted pear-shaped uterine cavity area; after the bristles finish sampling, the movable pipe is controlled to move towards the top bead, so that the bristles are folded and protected by the movable pipe; the sampling efficiency, the sample integrity and the diagnosis accuracy can be improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an endometrial sampler. BACKGROUND

[0002] In the field of gynecological disease diagnosis, diagnostic curettage (diagnostic curettage) has been used as the gold standard for endometrial sampling, but it has significant drawbacks: it requires general anesthesia in the operating room environment, and the patient experiences high levels of pain; the scraping area is less than 50%, resulting in a high rate of missed diagnosis; it can cause complications such as bleeding, infection, and uterine perforation, especially for endometrial polyps and other focal lesions, which have low detection rates. With the iteration of technology, negative pressure suction sampling technology has achieved outpatient operation, but it has not solved the problems of insufficient sample size (low sensitivity for atrophic endometrium or focal lesions) and contamination risk (mixing of vaginal / cervical impurities affecting the accuracy of microbial detection). The cell sampling device products that appeared in recent years have basically solved the above problems. The current mainstream cell sampling device adopts a straight tube structure design, and its typical features are: a brush assembly is arranged at the front end, and a movable protective tube is matched outside to prevent the brush from being contaminated. This type of product needs to be adapted to the anatomical structure of the cervical orifice (the average size of the cervical orifice is about 4mm), and the outer diameter of the protective tube needs to be controlled at about 3mm, which directly limits the expansion space of the brush length. The existing technical solutions achieve sampling operation through the relative movement of the protective tube and the brush, but due to the linear shape of the device, there is a technical bottleneck of insufficient sampling coverage.

[0003] The existing straight tube sampler has three technical defects:

[0004] Structural limitations: the spherical top bead design occupies the front end space, and the effective length of the brush is compressed;

[0005] Operation defects: the movable tube squeezes the brush during the pushing process, resulting in the loss of collected cell samples;

[0006] Morphological limitations: the linear device does not match the inverted pear-shaped uterine cavity anatomical structure, making it difficult to achieve full uterine cavity coverage sampling, and there is a risk of missed detection.

[0007] The above defects result in that the existing technology can achieve outpatient operation, but there is still room for improvement in sampling efficiency, sample integrity, and diagnostic accuracy. SUMMARY

[0008] To solve the above technical problems, the purpose of the present application is to provide an endometrial sampler to improve sampling efficiency, sample integrity, and diagnostic accuracy.

[0009] To achieve the above purpose, the present application provides the following technical solutions:

[0010] An endometrial sampler, comprising: a protective sleeve, a movable tube, a brush rod, a top bead, a brush, and a handle;

[0011] The protective sleeve and the movable tube are both hollow tubular structures, the movable tube is arranged in the protective sleeve and can move along the axial direction of the protective sleeve, the brush rod is arranged in the movable tube, one end of the brush rod is fixedly connected with the handle, the other end of the brush rod is fixedly connected with the top bead, a section of the brush rod close to the top bead is the front end of the brush rod, the brush hairs are attached to the front end of the brush rod, the brush hairs are inclined towards the direction of the top bead, and the top bead is in a half-enclosing cover shape.

[0012] During the sampling operation, the handle is rotated to drive the front end of the brush rod to rotate, so that the brush hairs cover the inverted pear-shaped uterine cavity area, and when the sampling of the brush hairs is completed, the movable tube is controlled to move towards the direction of the top bead, so that the brush hairs are gathered and protected by the movable tube.

[0013] Preferably, the front end of the brush rod and the rest of the brush rod are in a curved shape, and the bending angle ranges from 5° to 17°, and the length of the brush hairs ranges from 15 mm to 35 mm.

[0014] Preferably, the front end of the movable tube is in a flared shape, or the inner wall of the front end of the movable tube is uniformly provided with a collecting groove.

[0015] Preferably, the end of the brush hair closest to the top bead is in contact with the edge of the top bead, or extends out of the edge of the top bead by 1 mm to 3 mm.

[0016] Preferably, the maximum outer diameter of the movable tube ranges from 2.5 mm to 3.5 mm.

[0017] Preferably, the half-enclosing cover shape is in one of an umbrella shape and an inverted bowl shape.

[0018] Preferably, the brush rod is a double-stranded steel wire rope made of stainless steel.

[0019] Preferably, the movable tube is an elastic tube.

[0020] The present application has the following beneficial effects:

[0021] I. Improve sampling coverage and reduce missed detection rate: The front end of the endometrial sampler designed in the present application is in a curved shape, and the bending angle ranges from 5° to 17°. Since the uterine cavity is in an inverted pear shape, the existing straight tube sampler is difficult to fully cover the inside of the uterus, while the curved design of the present application enables the front end of the brush hair to sweep the inside of the uterine cavity to the greatest extent when the product is rotated, effectively obtaining more areas of the inside of the uterine cavity, greatly reducing the missed detection rate, improving the sampling efficiency, and overcoming the technical bottleneck of insufficient sampling coverage of the existing linear instrument.

[0022] II. Ensure the acquisition of effective tissue samples: the length of the brush of the present application is 15mm-35mm. The existing straight tube sampler occupies the front space due to the spherical top bead design, and the length of the brush is limited by the outer diameter of the protective tube. The longer brush length design of the present application ensures that the tissue taken is all inside the uterine cavity, avoiding the problem of insufficient brush length and inability to obtain effective tissue samples, improving the integrity of the sample, and helping to more accurately diagnose gynecological diseases.

[0023] III. Prevent sample loss and contamination: the top bead of the present application is designed as a semi-enclosed cover structure, preferably one of an umbrella shape or an inverted bowl shape. The spherical top bead design of the existing straight tube sampler occupies the front space, compresses the effective length of the brush, and squeezes the brush during the movement of the movable tube, resulting in the loss of collected cell samples. The umbrella-shaped top bead structure of the present application provides more space for the brush, and when the movable tube is pushed forward, it can fold as many brushes as possible, preventing the brush from being contaminated by other parts. At the same time, the end of the brush closest to the top bead is in contact with the edge of the top bead, or extends 1mm-3mm beyond the edge of the top bead. Through the folding action of the movable tube (preferably the front end is designed as a horn structure), the excess brush can be collected to avoid contamination of the sampler when it is taken out of the uterine cavity, ensuring the purity of the sample.

[0024] IV. Optimize the design of the movable tube to improve the collection effect: the front end of the movable tube of the present application is designed as a horn structure. The existing straight tube sampler has deficiencies in collecting cell samples, while the horn structure design of the present application can expand the collection range during the movement of the movable tube, ensuring that more uterine cavity cells can be collected, further improving the integrity of the sample and providing more abundant basis for the diagnosis of gynecological diseases.

[0025] V. In summary, the present application uniquely combines the protective sleeve, movable tube, brush rod, top bead, brush and handle. The hollow tubular structure of the protective sleeve and the movable tube and the axial movement design of the movable tube, combined with the fixed connection of the brush rod and the handle and the special design of the front end of the brush rod, make the entire sampler flexible to operate. The brush rod is made of double-stranded stainless steel wire, which ensures its strength and flexibility; the movable tube is designed as an elastic tube, which is convenient to move in the protective sleeve and can better adapt to various operations during sampling. This unique combination design improves the overall performance of the sampler, and each component cooperates to achieve the purpose of improving sampling efficiency, sample integrity and diagnostic accuracy. BRIEF DESCRIPTION OF DRAWINGS

[0026] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings needed to be used in the embodiments. It should be understood that the following drawings only show some of the embodiments of the present application, and therefore should not be regarded as a limitation to the scope. For those skilled in the art, other related drawings can also be obtained without creative labor.

[0027] Figure 1 The overall structure schematic diagram of the first embodiment of the present application.

[0028] Figure 2 The front end partial perspective view of the brush rod of the first embodiment of the present application (bristles are spread out).

[0029] Figure 3 The front end partial schematic view of the brush rod of the first embodiment of the present application (bristles are gathered).

[0030] Figure 4 The front end structure schematic view of the movable tube of the second embodiment of the present application.

[0031] In the figure: 1, protective sleeve; 2, movable tube; 3, brush rod; 4, top bead; 5, bristles; 6, handle. DETAILED DESCRIPTION

[0032] The technical solutions in the embodiments of the present application will be described clearly and completely below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, but not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of the present application.

[0033] As shown in the figure, an endometrial sampler comprises: a protective sleeve 1, a movable tube 2, a brush rod 3, a top bead 4, bristles 5, and a handle 6; Figures 1 to 3 The protective sleeve 1 and the movable tube 2 are both hollow tubular structures, the movable tube 2 is arranged in the protective sleeve 1 and can move along the axial direction of the protective sleeve 1; the brush rod 3 is arranged in the movable tube 2, one end of the brush rod 3 is fixedly connected with the handle 6, and the other end of the brush rod 3 is fixedly connected with the top bead 4; a section of the brush rod 3 close to the top bead 4 is the front end of the brush rod 3; the bristles 5 are attached to the front end of the brush rod 3, the bristles 5 are inclined towards the direction of the top bead 4, and the top bead 4 is in a half-enclosing cover shape;

[0034] During sampling operation, the handle 6 is rotated to drive the front end of the brush rod 3 to rotate, so that the bristles 5 cover the inverted pear-shaped uterine cavity area; after the sampling of the bristles 5 is completed, the movable tube 2 is controlled to move towards the direction of the top bead 4, so that the bristles 5 are gathered and protected by the movable tube 2.

[0035] ​

[0036] like Figures 1 to 3 As shown, this embodiment comprises a protective sleeve 1, a movable tube 2, a brush rod 3, a top bead 4, bristles 5, and a handle 6, forming an organic whole. Each component cooperates and works in conjunction with each other to achieve the function of efficiently and safely obtaining endometrial cell specimens. The protective sleeve 1 provides external protection and an operating channel for the entire sampler. The axial movement of the movable tube 2 within the protective sleeve 1 and the placement of the brush rod 3 within the movable tube 2 provide a flexible mechanical structure for the sampling and protection operations of the bristles 5. The handle 6 serves as the direct component for the operator to control the sampler. Through its fixed connection with the brush rod 3, the operator's movements are accurately transmitted to the front end of the brush rod 3 and the bristles 5. During the sampling operation, the operator rotates the handle 6. Since one end of the brush rod 3 is fixedly connected to the handle 6, the rotational motion of the handle 6 is transmitted to the brush rod 3, which in turn drives the front end of the brush rod 3 to rotate. The bristles 5 are attached to the front end of the brush rod 3 and tilted toward the top bead 4. The rotation of the front end of the brush rod 3 causes the bristles 5 to perform a circular motion, thereby covering the inverted pear-shaped area of ​​the uterine cavity. This design makes full use of the shape characteristics of the uterine cavity and expands the sampling range of the bristles 5 by rotating. Compared with the straight tube sampler, it can more comprehensively obtain endometrial cells, effectively reduce the missed detection rate, and improve sampling efficiency. The top bead 4 is set as a semi-enclosed cover structure. During the rotation sampling process of the bristles 5, the semi-enclosed cover structure provides a certain support and guidance for the bristles 5, so that the bristles 5 can rotate and sample more stably in the uterine cavity. At the same time, its unique shape also helps to reduce damage to uterine tissue. Moreover, this structure does not occupy too much front-end space like the spherical top bead 4, providing more sufficient sampling space for the bristles 5, ensuring that enough internal tissue samples of the uterine cavity can be obtained.

[0037] After the bristles 5 have completed sampling, the operator controls the movable tube 2 to move toward the top bead 4. Since the movable tube 2 is arranged in the protective sleeve 1 and can move along its axial direction, and the brush rod 3 is arranged in the movable tube 2, the movement of the movable tube 2 can accurately act on the bristles 5. As the movable tube 2 moves, the bristles 5 are gradually retracted into the movable tube 2. The flared front end design of the movable tube 2 (preferred case) can expand the collection range when the bristles 5 are retracted, better accommodate the bristles 5 and the cell samples collected therein, and at the same time reduce the squeezing of the cells on the bristles 5, preventing the loss of the collected cell samples. The semi-enclosed cover-like structure of the top bead 4 also plays an important role in the process of the movable tube 2 retracting the bristles 5. When the movable tube 2 retracts the bristles 5, the semi-enclosed cover-like structure can further protect the bristles 5 and prevent the bristles 5 from being contaminated by tissues in other parts such as the vagina or cervix during the process of being removed from the uterine cavity, thereby ensuring the purity of the collected endometrial cell samples and providing an accurate and reliable basis for the subsequent diagnosis of gynecological diseases.

[0038] like Figures 1 to 3As shown, the front end of the brush rod 3 presents a curved shape with the rest of the brush rod 3, with a bending angle ranging from 5° to 17°. The uterine cavity is not a completely regular straight space, but has a certain physiological curvature. The front end of the brush rod 3 presents a curved shape with the rest of the brush rod 3, with a bending angle of 5°-17°. This design enables the front end of the brush rod 3 to better fit the curved trend of the uterine cavity. During sampling, when the rotating handle 6 drives the brush rod 3 to rotate, the curved front end of the brush rod 3 can reach deeper into each corner of the uterine cavity, especially those parts that are difficult to reach by ordinary straight rods due to the curvature of the uterine cavity, thereby ensuring that the bristles 5 can cover a larger range of endometrial tissue, improving the comprehensiveness and accuracy of sampling, and reducing the possibility of missed detection. A suitable bending angle can ensure the sampling range while making the movement of the brush rod 3 in the uterine cavity more smooth and natural, avoiding unnecessary scratching and damage to the uterine tissue caused by forcibly inserting or rotating a straight rod, and reducing the discomfort of the patient.

[0039] The length of the bristles 5 is 15mm-35mm, which is carefully designed. Longer bristles 5 can contact more endometrial tissue during rotation, thereby collecting a sufficient amount of cell samples. A sufficient sample amount is crucial for subsequent pathological examination and diagnosis, which can improve the accuracy and reliability of diagnosis. The depth of the uterine cavity of different women may vary, but is generally within a certain range. The length of the bristles 5 of 15mm-35mm can adapt to the depth of the uterine cavity of most women, ensuring the sampling effect while not excessively stimulating the bottom of the uterus due to excessive length or failing to obtain sufficient samples due to insufficient length.

[0040] As shown in Figures 2 to 3 The front end of the movable tube 2 is provided with a flared structure. When the movable tube 2 is moved towards the top bead 4 to retract the bristles 5 after sampling is completed, the shape of the flared structure can play a guiding and expanding role. It can expand the collection range, making it easier and smoother for the bristles 5 to be retracted into the movable tube 2, reducing the jamming or extrusion of the bristles 5 during the retraction process, and ensuring that the bristles 5 and the cell samples collected thereby can be completely stored in the movable tube 2. The design of the flared structure can also reduce the extrusion of cells on the bristles 5 to some extent during the retraction of the bristles 5, prevent the loss of collected cell samples due to excessive extrusion, and ensure the integrity and quantity of the collected samples, providing sufficient effective samples for subsequent detection.

[0041] As shown in Figures 1 to 3As shown, the end of the bristles 5 closest to the top bead 4 is in contact with the edge of the top bead 4, or extends 1-3 mm beyond the edge of the top bead 4. When the end of the bristles 5 is in contact with the edge of the top bead 4, the top bead 4 can provide some support and protection for the bristles 5, keeping the bristles 5 stable during sampling and ensuring that the bristles 5 can effectively contact and collect endometrial cells. When the end of the bristles 5 extends 1-3 mm beyond the edge of the top bead 4, the bristles 5 can more fully contact the tissue in the uterine cavity, expand the sampling range, and improve the effectiveness of sampling, while ensuring that the top bead 4 provides some protection for the bristles 5. At the same time, this design can also prevent the tissue at the vaginal or cervical sites from contaminating the collected endometrial cell sample when the sampler is removed from the uterine cavity, ensuring the purity of the sample.

[0042] The outer diameter of the movable tube 2 is controlled to be within 3 mm, making the movable tube 2 relatively thin. During the process of inserting the sampler through the cervix into the uterine cavity, the thinner movable tube 2 can reduce the expansion and irritation of the cervix, reduce the discomfort and pain of the patient, and improve the acceptance and success rate of the operation. The thin movable tube 2 is more flexible and easier to accurately insert into the uterine cavity under guidance, making the operation more convenient and efficient, and allowing medical personnel to complete the sampling operation more easily, reducing the operation time and difficulty.

[0043] As shown in Figures 1 to 3 The half-enclosed cover-like structure is designed in one of an umbrella shape and a reverse-bowl shape. The reverse-bowl shape is adopted in this embodiment. The half-enclosed cover-like structure in the reverse-bowl shape can provide better protection for the bristles 5 and the collected cell sample. During sampling, it can prevent the bristles 5 from being disturbed and damaged by external factors, and its large internal space can accommodate a certain amount of bristles 5 and sample, preventing the sample from falling during the operation. The structure of the reverse-bowl shape can fit the shape of the uterine cavity to some extent, making the sampler enter the uterine cavity more smoothly, reducing the scraping and irritation of the uterine tissue, and improving the safety and comfort of the operation.

[0044] As shown in Figures 1 to 3 The brush rod 3 is made of stainless steel double-stranded steel wire rope. Stainless steel has high strength and corrosion resistance, which can ensure that the brush rod 3 is not easily deformed and damaged during repeated use, prolonging the service life of the sampler. The structure of the double-stranded steel wire rope gives the brush rod 3 good flexibility, allowing it to rotate and bend flexibly in the uterine cavity, better adapting to the shape of the uterine cavity and completing the sampling operation, while also being able to withstand the forces generated during rotation and movement, ensuring the stability of the operation. The smooth surface of stainless steel is not easy to attach bacteria and dirt, making it easy to clean and disinfect, meeting the hygiene requirements of medical devices, reducing the risk of cross-infection, and ensuring the safety of the patient.

[0045] The active tube 2 is provided as an elastic tube. The elastic tube has a certain elasticity. When the active tube 2 is controlled to move towards the top bead 4 to fold the bristles 5, the elastic tube can be self-adapted to a certain extent according to the shape and position of the bristles 5, so that the folding process is more smooth, and the sample loss or operation difficulty caused by the friction and jam between the active tube 2 and the bristles 5 is reduced. In the process that the sampler enters and exits the uterine cavity, the elastic tube can be deformed to a certain extent according to the shape change of the cervix and the uterine cavity, so that the extrusion and damage to the surrounding tissues are reduced, and the safety of the operation and the comfort of the patient are improved.

[0046] Second embodiment

[0047] As shown in Figure 4 The difference between the present embodiment and the first embodiment is that the front end of the active tube 2 is uniformly provided with a collection groove, which is mainly used for collecting cells. In this way, the outer diameter of the front end of the active tube 2 does not need to be enlarged, so as to facilitate the movement in the human body.

[0048] The above are only specific embodiments of the present application, but the technical features of the present application are not limited thereto. Any simple change, equivalent replacement or modification made on the basis of the present application to solve the same technical problem and achieve the same technical effect is also covered by the protection scope of the present application.

Claims

1. An endometrial sampler, characterized in that: include: A protective sleeve (1), a movable tube (2), a brush rod (3), a top bead (4), bristles (5) and a handle (6); The protective sleeve (1) and the movable tube (2) are both configured as hollow tubular structures, the movable tube (2) is arranged in the protective sleeve (1) and can move along the axial direction of the protective sleeve (1); the brush rod (3) is arranged in the movable tube (2), one end of the brush rod (3) is fixedly connected to the handle (6), and the other end of the brush rod (3) is fixedly connected to the top bead (4); a section of the brush rod (3) close to the top bead (4) is configured as the front end of the brush rod (3); the bristles (5) are attached to the front end of the brush rod (3), the bristles (5) are inclined toward the top bead (4), and the top bead (4) is configured as a semi-enclosed cover-shaped structure; During the sampling operation, the handle (6) is rotated to drive the front end of the brush rod (3) to rotate, so that the bristles (5) cover the inverted pear-shaped uterine cavity area; when the bristles (5) complete the sampling, the movable tube (2) is controlled to move toward the top bead (4), so that the bristles (5) are retracted and protected by the movable tube (2).

2. The endometrial sampler according to claim 1, characterized in that: The front end of the brush rod (3) and the rest of the brush rod (3) are in a curved shape, with a bending angle ranging from 5° to 17°; the length of the bristles (5) is from 15 mm to 35 mm.

3. The endometrial sampler according to claim 1, characterized in that: The front end of the movable tube (2) is configured as a bell-mouth structure or the inner wall of its front end is evenly provided with collecting grooves.

4. The endometrial sampler according to claim 1, characterized in that: The end of the bristle (5) closest to the top bead (4) contacts the edge of the top bead (4) or extends 1 mm to 3 mm beyond the edge of the top bead (4).

5. The endometrial sampler according to claim 1, characterized in that: The maximum outer diameter of the movable tube (2) is in the range of 2.5 to 3.5 mm.

6. The endometrial sampler according to claim 1, characterized in that: The semi-enclosed cover-shaped structure is configured as an umbrella shape or an inverted bowl shape.

7. The endometrial sampler according to claim 1, characterized in that: The brush rod (3) is configured as a double-twisted steel wire rope made of stainless steel.

8. The endometrial sampler according to claim 1, characterized in that: The movable tube (2) is configured as an elastic tube.

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