A biomimetic flexible augmenting sampler for endometrial cells

Abstract

A kind of biomimetic flexible adhesion sampler for endometrial cells relates to medical biomimetic technical field, including handle, outer sleeve, inner core rod, piston tube, hemispherical head and brush, brush is curved, the foremost end of inner core rod is smooth hemispherical head, piston tube is set on the inner core rod below brush, piston tube inner wall is sealingly connected with the surface of inner core rod, outer sleeve is set on the outer surface of inner core rod, inner core rod and piston tube are located in outer sleeve, the last end of inner core rod is provided with handle, the outer wall of piston tube and the inner wall of outer sleeve are slidably connected to form suction cylinder, inner core rod, piston tube and outer sleeve are flexible and can be bent, brush has multiple layers of bristles, multiple layers of bristles are arranged along the axial direction of inner core rod, and the bristles of each layer of bristles are in the form of gecko foot pad setae structure, to increase the contact area with tissue surface and enhance the adhesion, increase the amount of cell sample.

Description

Technical Field

[0001] This invention relates to the field of medical bionics technology, and in particular to a bionic flexible augmentation sampler for endometrial cells. Background Technology

[0002] Endometrial cancer is one of the most common malignant tumors of the female reproductive system, with a lifetime risk of approximately 3% in women. According to 2022 statistics, there were approximately 417,000 new cases globally, accounting for 4.5% of all female malignant tumors. Data released by the my country Cancer Center shows that in 2022, the incidence rate of endometrial cancer in China was 7.03 per 100,000 people, and the mortality rate was 1.06 per 100,000 people. In some regions, endometrial cancer has become the leading cause of malignant tumors of the female reproductive system, seriously threatening women's health. Early-stage endometrial cancer has a good prognosis, with a 5-year survival rate exceeding 90%, while late-stage endometrial cancer has a poor prognosis, with a 5-year survival rate of 0-89%. The slow metastasis of endometrial cancer facilitates early diagnosis and treatment. Furthermore, endometrial cancer has relatively clear high-risk factors; therefore, establishing efficient, convenient, and minimally invasive / non-invasive endometrial cancer screening methods and strategies in high-risk populations is expected to enable early detection of endometrial atypical hyperplasia and endometrial cancer, reducing the incidence and mortality rates of endometrial cancer.

[0003] Currently, there are many types of tools available for endometrial cancer screening, but they have drawbacks such as low tissue sample acquisition rate, easy to miss diagnoses, and high price. Therefore, it is urgent to solve the problem of inventing an efficient and inexpensive endometrial and cervical canal mucosal cell sampler.

[0004] Nature has provided inspiration for solving this challenging problem. Research shows that gecko feet are a natural biomimetic adhesion system composed of complex multi-scale, multi-level fractal structures. From macroscopic to micro-nano scales, its structure includes the foot, toes, lamellae (toe pad folds), setae (setae), and branching structures at the seta ends. The setae as a whole exhibit a multi-level composite structure, where finer-scale branched fiber structures further differentiate on the micron-scale seta surface, with each branch ending in a spoon-shaped configuration. This multi-level composite structure significantly increases the actual contact area with the interface, generating and superimposing a large number of van der Waals forces between the flattened end structure and the contacted surface, thus achieving an efficient, reversible, and stable adhesion effect. Summary of the Invention

[0005] The purpose of this invention is to address the problems existing in the prior art by providing a biomimetic flexible augmentation sampler for endometrial cells, so as to ensure efficient and sufficient acquisition of cell samples and reduce the rate of missed diagnoses.

[0006] A biomimetic flexible agglutination sampler for endometrial cells includes a handle, an outer tube, an inner core rod, a piston tube, a hemispherical head, and a brush. The brush is curved, and the inner core rod has a smooth hemispherical head at its front end. The piston tube is fitted onto the inner core rod below the brush, and the inner wall of the piston tube is sealed to the surface of the inner core rod. The inner core rod is fitted with an outer tube, and both the inner core rod and the piston tube are located inside the outer tube. A handle is provided at the rear end of the inner core rod. The inner core rod, brush, and piston tube can all retract into the outer tube. The outer wall of the piston tube and the inner wall of the outer tube slide in contact to form an air suction cylinder. The inner core rod, piston tube, and outer tube are flexible and can be bent to meet and adapt to the curved structure of the vagina and uterus.

[0007] The brush is inverted conical in shape and has multiple layers of bristles. These layers of bristles are spaced apart along the axial direction of the inner core rod, with a spacing of 3.7-5.6 mm. Each layer of bristles consists of multiple bristle needles. The bristle needles of each layer are arranged radially around the inner core rod and fixed to it. The inner core rod of the brush section is arc-shaped. The length of a single bristle needle at the bottom of the cone is 1.5-2.5 cm, and the length of a single bristle needle at the tip of the cone is 0.2-0.4 cm. The height of the brush is 3-4.5 cm.

[0008] The single hair needle is designed to mimic the bristle structure of a gecko's foot pad. Each single hair needle has several tufts of villi, which mimic the detailed structure of a gecko's foot bristles. Each villi is composed of several villi, which mimic the villi structure at the end of a gecko's foot bristle. The ends of the villi are spoon-shaped to increase the contact area with the tissue surface and enhance adhesion.

[0009] The hair needles are micron-sized fibers, while the tufts and down are nano-sized fibers.

[0010] The spoon-shaped configuration is a sheet-like or flattened end structure with a lateral dimension larger than the diameter of the corresponding branch fiber. This structure can significantly increase the effective contact area during contact with the endometrium, allowing van der Waals forces to accumulate and amplify, thereby enhancing the capture ability and adhesion stability of exfoliated cells. The inner core rod of the brush segment is curved, with a bending angle of 10-25°, which helps to adapt to the bending angle formed by the uterine cavity and cervical canal on the longitudinal axis of the lumen, and facilitates the acquisition of endometrial cells from uteri with greater bending.

[0011] The piston tube is located on the inner core rod 1cm below the brush. The piston tube is 2cm long and has an outer diameter of 2.8-3mm. The outer wall of the piston tube and the inner wall of the outer sleeve slide together to form an air suction cylinder. When the inner core rod is pulled back, a negative pressure is formed in the cavity of the outer sleeve near the brush end, which is conducive to the recovery of cell samples and increases the amount of cell samples obtained.

[0012] The end of the outer tube near the brush is funnel-shaped. This structure reduces the rate of cell sample detachment when the brush retracts into the outer tube, thereby increasing the amount of cell sample obtained.

[0013] The inner core rod, piston tube, and outer sleeve are flexible and bendable to meet and adapt to the curved structure of the vagina and uterus.

[0014] The handle, outer tube, inner core rod, piston tube, hemispherical head, and brush are made of medical-grade plastics, such as PE, PP, PET, or PU.

[0015] The procedure for using this invention to collect endometrial cells is as follows: During cell sampling, the entire brush is retracted into the outer sheath. The tip of the inner core rod is inserted into the cervical canal of the uterine body. When the hemispherical head of the inner core rod reaches the fundus of the uterus, the outer sheath is pulled outward to the handle, exposing the entire brush inside the uterine cavity. The handle is rotated clockwise 10-15 times to allow the bristles to rotate within the uterine cavity, brushing the endometrial cells. The inverted conical shape of the brush conforms to the shape of the uterine cavity, increasing the brushing area, especially for brushing endometrial cells at the bilateral uterine horns. The gecko-like pads on the brush are... The bristle structure design increases the adhesion of the bristles to the endometrial cells by increasing the van der Waals force between the bristles and the endometrial cells, greatly increasing the endometrial cell retrieval rate. After brushing, the inner core rod is pulled back, causing the entire brush to retract into the outer tube. The funnel-shaped design of the outer tube near the brush end reduces the cell sample detachment rate when the brush retracts into the outer tube. The outer wall of the piston tube and the inner wall of the outer tube slide together to form an air suction cylinder, which creates negative pressure in the outer tube lumen near the brush end when the inner core rod is pulled back, which is beneficial for cell sample recovery.

[0016] The inner core rod, piston tube, and outer sleeve are all flexible and bendable, which facilitates the sampler's smooth entry into the uterine cavity and allows it to adapt to different uterine cavity structures. The curved brush conforms to the shape of the uterus, making better contact with the uterine wall.

[0017] Compared with the prior art, the beneficial effects of the present invention are as follows: Because the brush head can retract into the outer tube, it avoids irritation to the vaginal wall and cervical canal when entering the vagina and cervical canal, reducing patient discomfort. At the same time, it avoids contamination of the sample with vaginal secretions and cervical mucosal cells. The brush head is inverted cone-shaped, which conforms to the shape of the uterine cavity, increasing the brushing area while also brushing the endometrium at both uterine horns. The design of the bristles on each bristle, which resembles the bristles of a gecko's foot, further increases the adhesion of the bristles to the endometrial cells, greatly increasing the amount of cell sample obtained.

[0018] The outer tube adopts a funnel-shaped design near the bristle end to reduce the cell sample detachment rate when the brush head retracts into the outer tube. The fixing tube and the outer tube fit together perfectly. When the inner core rod is pulled back, a negative pressure is formed in the lumen of the outer tube near the bristle end, which is conducive to the recovery of cell samples and increases the amount of cell samples obtained.

[0019] The inner core rod is curved at the lowest end of the brush head, with a bending angle of 10-25°. This helps to adapt to the bending angle formed by the uterine cavity and cervical canal on the longitudinal axis of the lumen, and facilitates the acquisition of endometrial cells from uteri with greater bending. Attached Figure Description

[0020] Figure 1 This is a three-dimensional schematic diagram of an embodiment of the present invention; Figure 2 This is a three-dimensional schematic diagram of an embodiment of the present invention with the outer sleeve removed; Figure 3 This is a view of the brush head according to an embodiment of the present invention; Figure 4 This is a three-dimensional schematic diagram of the brush head according to an embodiment of the present invention; Figure 5 This is a three-dimensional schematic diagram of the bristles of the brush head according to an embodiment of the present invention; Figure 6 This is a three-dimensional schematic diagram of the bristle needles of the first layer of bristles in an embodiment of the present invention; Figure 7 This is a three-dimensional schematic diagram of the bristle needles of the second layer of bristles in an embodiment of the present invention; Figure 8 This is a three-dimensional schematic diagram of the bristle needles of the third layer of bristles in an embodiment of the present invention; Figure 9 This is a three-dimensional schematic diagram of the bristle needles of the fourth layer of bristles in an embodiment of the present invention; Figure 10 This is a three-dimensional schematic diagram of the bristle needles of the fifth layer of bristles in an embodiment of the present invention; Figure 11 This is a three-dimensional schematic diagram of the bristle needles of the sixth layer of bristles in an embodiment of the present invention; Figure 12 This is a three-dimensional schematic diagram of the bristle needles of the seventh layer of bristles in an embodiment of the present invention; Figure 13 This is a three-dimensional schematic diagram of the bristle needles of the eighth layer of bristles in an embodiment of the present invention; Figure 14 This is a three-dimensional schematic diagram of a tuft of fluff according to an embodiment of the present invention; Figure 15 This is a three-dimensional schematic diagram of the outer tube according to an embodiment of the present invention; Figure 16 This is a partial three-dimensional schematic diagram of the outer sleeve according to an embodiment of the present invention; Figure 17 This is a three-dimensional schematic diagram of the piston tube according to an embodiment of the present invention; Figure 18 This is a three-dimensional schematic diagram of the handle according to an embodiment of the present invention; Figure 19 This is a three-dimensional schematic diagram of the hemispherical head according to an embodiment of the present invention; Figure 20 This is a schematic diagram of the working state of an embodiment of the present invention; Figure 21 This is a schematic diagram of the brush bending angle according to an embodiment of the present invention; Figure 22 A photo showing the bristle structure of a gecko's foot pads; Figure 23 A photo showing the detailed structure of the bristles on a gecko's foot; Figure 24 This is a photograph of the villous structure at the tip of the bristles on a gecko's foot.

[0021] Wherein: 1-handle; 2-outer tube; 21-funnel shape; 3-inner core rod; 4-piston tube; 5-hemispherical head; 6-brush; 61-first layer of bristles; 62-second layer of bristles; 63-third layer of bristles; 64-fourth layer of bristles; 65-fifth layer of bristles; 66-sixth layer of bristles; 67-seventh layer of bristles; 68-eighth layer of bristles; 611-hair needle; 6111-tuft of villi; 61111-villi; 7-fundus of uterus; 8-uterine cavity; 9-uterine body; 10-cervical canal. Detailed Implementation

[0022] Please see Figure 1 , Figure 2 and Figures 15 to 19 As shown, a biomimetic flexible agglutination sampler for endometrial cells includes a handle 1, an outer tube 2, an inner core rod 3, a piston tube 4, a hemispherical head 5, and a brush 6. The brush 6 is curved. The front end of the inner core rod 3 is a smooth hemispherical head 5. The piston tube 4 is fitted onto the inner core rod 3 below the brush 6. The inner wall of the piston tube 4 is sealed to the surface of the inner core rod 3. The outer tube 2 is fitted over the inner core rod 3. Both the inner core rod 3 and the piston tube 4 are located inside the outer tube 2. The handle 1 is provided at the far end of the inner core rod 3. The inner core rod 3, the brush 6, and the piston tube 4 can all retract into the outer tube 2. The outer wall of the piston tube 4 and the inner wall of the outer tube 2 slide and engage to form an air suction cylinder. The inner core rod 3, the piston tube 4, and the outer tube 2 are flexible and can be bent to meet and adapt to the curved structure of the vagina and uterus.

[0023] Please see Figure 3 and Figure 4As shown, the brush 6 is inverted conical in shape and has a first layer of bristles 61, a second layer of bristles 62, a third layer of bristles 63, a fourth layer of bristles 64, a fifth layer of bristles 65, a sixth layer of bristles 66, a seventh layer of bristles 67, and an eighth layer of bristles 68. Each of the first, second, third, fourth, fifth, sixth, and eighth layers of bristles 68 is composed of 15 bristle needles 611. Figures 5 to 13 As shown, 15 bristle needles 611 are arranged radially around the inner core rod 3 and fixed to it. The inner core rod 3 of the brush segment 6 is arc-shaped. The first layer of bristles 61, the second layer of bristles 62, the third layer of bristles 63, the fourth layer of bristles 64, the fifth layer of bristles 65, the sixth layer of bristles 66, the seventh layer of bristles 67, and the eighth layer of bristles 68 are all arranged at intervals along the axial direction of the inner core rod 3. Figure 3 , Figure 4 and Figure 5 As shown, the spacing between adjacent layers of bristles is 3.7-5.6 mm, the length of a single bristle 611 in the eighth layer of bristles 68 is 1.5-2.5 cm, the length of a single bristle 611 in the first layer of bristles 61 is 0.2-0.4 cm, and the height of the brush 6 is 3-4.5 cm.

[0024] Please see Figures 6 to 13 As shown, the needle 611 has a gecko-like foot pad bristle structure, as illustrated in the diagram. Figure 22 As shown; please refer to Figure 14 As shown, the needle 611 has 10 tufts of downy hairs 6111, and the downy hair tufts 6111 have a detailed structure resembling the bristles of a gecko's foot. The detailed structure of the bristles of a gecko's foot is as follows: Figure 23 As shown, the tuft of hairs 6111 is composed of 9 hairs 61111. The hairs 61111 are modeled after the hair structure at the end of the setae on a gecko's foot, as shown in the image. Figure 24 As shown, the ends of the villi 61111 are spoon-shaped to increase the contact area with the tissue surface and enhance adhesion.

[0025] The hair needles 611 are micron-sized fibers, while the tufts 6111 and the downy hairs 61111 are nano-sized fibers.

[0026] The spoon-shaped configuration is a sheet-like or flattened end structure with a lateral dimension larger than the diameter of the corresponding branch fiber. This structure can significantly increase the effective contact area during contact with the endometrium, allowing van der Waals forces to accumulate and amplify, thereby enhancing the capture ability and adhesion stability of exfoliated cells. The inner core rod 3 of the six sections of the brush is curved, with a bending angle of 10-25°. Figure 21 As shown, this facilitates adaptation to the tortuous angle formed by the uterine cavity and cervical canal along the longitudinal axis of the lumen, and increases the acquisition of endometrial cells from uteri with greater tortuosity.

[0027] The piston tube 4 is located on the inner core rod 3 1 cm below the brush 6. The piston tube 4 is 2 cm long and has an outer diameter of 2.8-3 mm. The outer wall of the piston tube 4 and the inner wall of the outer sleeve 2 are in contact and sliding fit to form an air suction cylinder. When the inner core rod 3 is pulled back, a negative pressure is formed in the cavity of the outer sleeve 2 near the brush end, which is conducive to the recovery of cell samples and increases the amount of cell samples obtained.

[0028] The end of the outer tube 2 near the brush is funnel-shaped 21. This structure reduces the rate of cell sample detachment when the brush retracts into the outer tube, thereby increasing the amount of cell sample obtained.

[0029] The inner core rod 3, piston tube 4, and outer sleeve 2 are flexible and bendable to meet and adapt to the curved structure of the vagina and uterus.

[0030] The handle 1, outer tube 2, inner core rod 3, piston tube 4, hemispherical head 5, and brush 6 are made of medical-grade plastics, such as PE, PP, PET, or PU.

[0031] The procedure for using this invention to collect endometrial cells is as follows: like Figure 20 As shown, during cell sampling, the brush 6 is completely retracted into the outer sleeve 2, and the tip of the inner core rod 3 is inserted into the cervical canal 10 of the uterine body 9. When the hemispherical head 5 of the inner core rod 3 reaches the fundus 7 of the uterus, the outer sleeve 2 is pulled outward to the handle 1, so that the brush 6 is completely exposed in the uterine cavity 8. The handle is rotated clockwise 10-15 times to make the bristles rotate in the uterine cavity 8 to brush the endometrial cells. The inverted conical shape of the brush 6 conforms to the shape of the uterine cavity 8, increasing the brushing area, especially for brushing endometrial cells at the bilateral uterine horns. The gecko-like feet on the brush 6 The bristle structure 6111 increases the adhesion of the bristles to the endometrial cells by increasing the van der Waals force between the bristles and the endometrial cells, greatly increasing the endometrial cell retrieval rate. After brushing, the inner core rod 3 is pulled back, causing the brush 6 to retract completely into the outer tube 2. The funnel-shaped design 21 of the outer tube 2 near the brush end reduces the cell sample detachment rate when the brush 6 retracts into the outer tube 2. The outer wall of the piston tube 4 and the inner wall of the outer tube 2 slide together to form an air suction cylinder, so that when the inner core rod 3 is pulled back, a negative pressure is formed in the lumen of the outer tube 2 near the brush end, which is conducive to the recovery of cell samples.

[0032] The inner core rod 3, piston tube 4 and outer sleeve 2 are all flexible and bendable, which facilitates the sampler to pass smoothly through the vagina into the uterine cavity and can adapt to different shapes of the uterine cavity 8. The curved brush 6 conforms to the shape of the uterus and makes better contact with the uterine wall.

Claims

1. A biomimetic flexible agglutination sampler for endometrial cells, characterized in that: It includes a handle (1), an outer tube (2), an inner core rod (3), a piston tube (4), a hemispherical head (5), and a brush (6). The brush (6) is curved. The front end of the inner core rod (3) is a smooth hemispherical head (5). The piston tube (4) is fitted on the inner core rod (3) below the brush (6). The inner wall of the piston tube (4) is sealed to the surface of the inner core rod (3). The inner core rod (3) is fitted with an outer tube (2). The inner core rod (3) and the piston tube (4) are both located inside the outer tube (2). The handle (1) is provided at the end of the inner core rod (3). The inner core rod (3), the brush (6), and the piston tube (4) can all be retracted into the outer tube (2). The outer wall of the piston tube (4) and the inner wall of the outer tube (2) are in contact and sliding fit to form an air pump.

2. The biomimetic flexible agglutination sampler for endometrial cells according to claim 1, characterized in that: The brush (6) is inverted cone shape and has multiple layers of bristles with a spacing of 3.7-5.6 mm. The multiple layers of bristles are arranged axially along the inner core rod (3). Each layer of bristles is composed of multiple bristle needles (611). The bristle needles (611) at the bottom of the cone are 1.5-2.5 cm long, and the bristle needles (611) at the tip of the cone are 0.2-0.4 cm long. The height of the brush (6) is 3-4.5 cm. The multiple bristle needles (611) of each layer of bristles are arranged radially around the inner core rod (3) and fixed on the inner core rod (3). The inner core rod (3) of the brush (6) section is arc-shaped.

3. The biomimetic flexible agglutination sampler for endometrial cells according to claim 2, characterized in that: The hair needle (611) is a structure that imitates the bristles of a gecko's foot pad. The hair needle (611) has several tufts of downy hair (6111). The tufts of downy hair (6111) are a detailed structure that imitates the bristles of a gecko's foot. The tufts of downy hair (61111) are composed of several downy hairs (61111). The downy hairs (61111) are a downy structure that imitates the end of the bristles of a gecko's foot. The end of the downy hairs (61111) is spoon-shaped.

4. A biomimetic flexible agglutination sampler for endometrial cells according to claim 2 or 3, characterized in that: The hair needles (611) are micron-sized fibers, while the tufts (6111) and the down (61111) are nano-sized fibers.

5. A biomimetic flexible agglutination sampler for endometrial cells according to claim 3, characterized in that: The spoon-shaped configuration is a sheet-like or flattened end structure.

6. The biomimetic flexible agglutination sampler for endometrial cells according to claim 1, characterized in that: The inner core rod (3) of the brush (6) section has a bending angle of 10-25°.

7. The biomimetic flexible agglutination sampler for endometrial cells according to claim 1, characterized in that: The end of the outer tube (2) near the brush is funnel-shaped (21).

8. The biomimetic flexible agglutination sampler for endometrial cells according to claim 1, characterized in that: The inner core rod (3), piston tube (4) and outer tube (2) are flexible and can be bent.

9. A biomimetic flexible agglutination sampler for endometrial cells according to claim 1, characterized in that: The handle (1), outer tube (2), inner core rod (3), piston tube (4), hemispherical head (5) and brush (6) are made of medical plastic.

10. A biomimetic flexible agglutination sampler for endometrial cells according to claim 9, characterized in that: The medical plastics mentioned are PE, PP, PET or PU.

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