WO2023155486A1 - 可调节长度的自采宫颈细胞取样器及取样、存样方法 - Google Patents

可调节长度的自采宫颈细胞取样器及取样、存样方法 Download PDF

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Publication number
WO2023155486A1
WO2023155486A1 PCT/CN2022/129604 CN2022129604W WO2023155486A1 WO 2023155486 A1 WO2023155486 A1 WO 2023155486A1 CN 2022129604 W CN2022129604 W CN 2022129604W WO 2023155486 A1 WO2023155486 A1 WO 2023155486A1
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brush
sleeve
cervical
sampling
rod
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PCT/CN2022/129604
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English (en)
French (fr)
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周亮高
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津泰(天津)医疗器械有限公司
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Publication of WO2023155486A1 publication Critical patent/WO2023155486A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy

Definitions

  • the invention belongs to the technical field of medical detection and relates to cervical brush technology, in particular to a self-collecting cervical cell sampler with adjustable length.
  • Cervical cell sampling brushes are required for clinical gynecological examinations such as cervical lesion inspection and HPV virus inspection.
  • cervical cell sampling is mostly carried out in clinical departments of medical institutions, and most of the medical devices used are simple cervical cell collectors. Composed of a brush head and a thin handle, the brush head and handle can be rotated synchronously and detachable.
  • the disadvantage of this sampling brush and sampling method is that the vagina needs to be dilated by the dilator first, and the cervix can be completely exposed to the sampler's field of vision before sampling, and the cervical cell sampling operation can only be performed by professional medical personnel in medical institutions .
  • This sampling method requires the use of two medical devices, which limits the sampling efficiency, wastes medical consumables, and cannot take care of individual patients with privacy sampling needs; therefore, it is necessary to develop a self-collecting cervical cell sampler with adjustable length and Sampling and storage methods.
  • the purpose of the present invention is to overcome the deficiencies of the prior art, and provide a self-collecting cervical cell sampler with adjustable length and a method for sampling and storing samples.
  • the cervical brush of the sampler is convenient for sampling and has a high degree of comfort.
  • the actual sampling distance can be adjusted in multiple gears, and combined with the design of the sampling bottle, the sampling efficiency is greatly improved.
  • a self-harvesting cervical cell sampler with adjustable length includes a cervical brush, the cervical brush includes a sleeve, a brush rod and a brush head, the sleeve is a hollow cylinder structure with openings at both ends, and the brush rod is the same as
  • the shaft is set through the sleeve, and the front end of the brush rod is coaxially equipped with a brush head.
  • the side wings divide the sleeve into a body part and a non-body part; the body part is the part from the side wings to the front end of the sleeve, and the outer surface of this part is smoothed; the non-body part is the part from the side wings to the front end of the sleeve.
  • the part at the rear end of the sleeve, the peripheral wall of the sleeve of this part is a prismatic structure;
  • the brush rod includes a rod body, the front end of the rod body is provided with a brush head plug; it is used to connect the brush head coaxially; the rear end of the rod body is provided with a brush handle; The position part and the multi-level adjustment locking part; the movement trend of the brush rod to the rear end of the sleeve is locked by the composite locking part with the limit protrusion in the sleeve; the multi-level adjustment locking part can be connected with the inside of the sleeve
  • the limit protrusions form a locking fit;
  • the composite locking portion includes two sets of elastic members arranged oppositely along the axial direction of the rod body, each set of elastic members includes two oppositely arranged elastic arms, and a locking point is formed between the two elastic arms, and the locking point Cooperate with the limit protrusion of the sleeve to form a stop, and the elastic arm at the front end is inclined radially outward; the end of the elastic arm at the rear end is formed with a middle limit stopper; and it is close to the middle limit stopper
  • the outer side of the elastic arm at the position is made with rear side forward gear protrusions;
  • the multi-gear adjustment locking part includes a plurality of gear positions that are evenly spaced and spaced along the axial direction of the rod body, and each gear position is composed of oppositely arranged limiting protrusions.
  • the sampling bottle used in conjunction with a cervical brush
  • the sampling bottle includes a bottle cap, a reagent bottle and a suction cup base, and the coaxial thread of the bottle cap is installed on the opening of the reagent bottle; the suction cup base is made of silica gel It is installed coaxially at the bottom of the reagent bottle.
  • the suction cup base includes a mounting part and a suction cup, and a mounting part is coaxially formed on the upper surface of the suction cup, and the mounting part is a hollow cylindrical structure suitable for the reagent bottle.
  • annular groove is formed on the outer wall of the front end of the sleeve.
  • a protruding ring is formed on the inner wall of the reagent bottle close to the opening, and the protruding ring is adapted to the ring groove of the sleeve.
  • arc-shaped protrusions are formed symmetrically on both sides of the brush handle, and a serration structure is formed on one of the arc-shaped protrusions of the brush handle.
  • the brush head includes a connecting platform connected to the brush head plunger, and three rings of bristles with different lengths are radially spaced on the connecting platform, and the length of each ring of bristles increases radially inward.
  • the hat is a flower-shaped hat, including a cap body, the front end of the cap body is a cap mouth, the inner diameter of the cap mouth is adapted to the outer diameter of the front end of the sleeve, and a A pattern placing seat, the seat arm of the pattern placing seat extends radially outward along the cap opening to the cap tail to form a pattern.
  • the bottom of the reagent bottle is made into a conical structure, and a plurality of reinforcing scrapers are evenly spaced along the circumferential direction of the inner wall of the conical structure; an annular mounting part extends axially from the bottom of the reagent bottle , and the conical structure is located inside the annular mounting part.
  • sampling and storage method of the self-collecting cervical cell sampler with adjustable length comprises the following steps:
  • Step 1 Wash your hands before use, tear open the small packaging bag, and take out the cervical brush;
  • Step 2 Take off the cap, press both sides of the sleeve of the cervical brush with your thumb and forefinger, and pull it out, making sure that your hands cannot touch the bristles of the cervical brush;
  • Step 3 Take samples in a standing or lying position, insert the cervical brush into the vagina until the two wings of the sleeve stick to the labia, hold the sleeve with one hand, and push the brush rod with the other hand so that the bristles partly touch the cervix.
  • the hour hand rotates 5-7 weeks;
  • Step 4 After the rotation sampling is completed, pull the brush rod so that the bristle part is completely retracted into the sleeve;
  • Step 5 Pull back the sleeve and take out the cervical brush, screw the sleeve into the matching storage solution tube, push the brush rod to completely immerse the bristles in the storage solution, and rotate for 7-10 cycles to make the sampling brush cells fall out of the storage solution .
  • the cervical brush of the sampler of the present invention is convenient for sampling and has a high degree of comfort, and can be adjusted in multiple gears according to the actual sampling distance, and combined with the design of the sampling bottle, the sampling efficiency is greatly improved.
  • Fig. 1 is a schematic diagram of the explosion structure of the present invention
  • Fig. 2 is a perspective view of the present invention
  • Fig. 3 is a schematic diagram of the transfer state of cervical cells of the present invention.
  • Fig. 4 is a partially enlarged view of the brush rod of the present invention.
  • Fig. 5 is the structural representation of reagent bottle of the present invention.
  • Figure 6 is an enlarged view of the cervical brush and sampling bottle assembly of the present invention.
  • Fig. 7 is a partially enlarged view of the assembly of the sleeve and the brush rod of the present invention.
  • a self-harvesting cervical cell sampler with adjustable length includes a cervical brush, the cervical brush includes a sleeve 4, a brush rod 2 and a brush head 3, the sleeve is a hollow cylinder structure with two ends open, the The brush rod is set coaxially through the sleeve, and the front end of the brush rod is coaxially equipped with a brush head, and the front end of the sleeve is coaxially covered with a cap 5, which is used to close the front end of the sleeve and protect the brush head ;
  • the middle part of the sleeve is provided with a limit protrusion; the limit protrusion is an annular protrusion, and the outer wall of the sleeve is also formed with side wings 4-2;
  • a circle of (arc or plane) side wings is designed at the center of the sleeve, and an arc or plane perpendicular to the brush rod is formed on the outer circumference of the sleeve, and the side wings divide the sleeve into the body part 4- 3 and the non-body-entry part 4-1; wherein the body-entry part is the part from the side wings to the front end of the sleeve, and the outer surface of this part is smoothened, thereby reducing the discomfort of the brush rod penetrating into the vagina, and its length is The body sampling distance; the non-body-entry part is the part from the side wings to the rear end of the sleeve.
  • the outer peripheral wall of this part of the sleeve is a prismatic structure, which prevents rotation and is easy to hold, and does not miss any experience details; this embodiment adopts the sleeve
  • the material is selected from high-quality plastics that meet the requirements of medical use. For details, please refer to existing similar products;
  • the function of the above-mentioned flanks is to limit the length of the sleeve deep into the body during sampling, so as to avoid damage caused by the sleeve entering the human body too long due to misoperation, that is, to control the aforementioned sampling distance into the body.
  • the specific distance range follows the following Specifications, the length of the side wings into the body is 4cm to 6cm, and the length of the brush head is 3cm to 4cm.
  • the brush rod includes a rod body, and the front end of the rod body is provided with a brush head plug post 2-5; the brush head plug post is used for coaxially connecting the brush head; the rear end of the rod body is provided with a brush handle 1; Pointing to the direction of the rear end, there are sequentially formed a composite locking part 2-4 and a multi-level adjustment locking part 2-1; the movement trend of the brush rod to the rear end of the sleeve is determined by the combination of the composite locking part and the limit protrusion in the sleeve.
  • the multi-level adjustment locking part can form a locking fit with the limit protrusion in the sleeve;
  • the brush rod is made of high-quality plastic, and the two ends are integrally formed with the rod body and the middle part is suspended.
  • the strip-shaped part is elastic, and then the structure of the composite clamping part and the multi-level adjustment and locking part is formed on each strip-shaped part;
  • the composite locking portion includes two sets of elastic members arranged oppositely along the axial direction of the rod body, each set of elastic members includes two oppositely arranged elastic arms, and the locking points 2-6 are formed between the two elastic arms.
  • the locking point and the limiting protrusion of the sleeve form a cooperative stop, and the elastic arm 2-4-2 at the front end is set radially outward; when the locking is in place, the function of anti-return undercut is realized to prevent the brush rod Pull out from the direction of the rear end of the sleeve; the end of the elastic arm at the rear end is formed with a middle limit gear column 2-4-3; and the outer side of the elastic arm near the position of the middle limit gear column is formed with a rear forward push position Protrusion 2-4-1, the setting of the middle limit gear column and the forward push gear protrusion on the rear side make the push rod push out more smoothly;
  • the multi-gear adjustment locking part includes a plurality of gear positions that are evenly spaced along the axial direction of the rod body, and the multiple gear positions are respectively the first gear position, the second gear position, and the third gear position along the direction from the front end to the rear end. , the fourth gear, the fifth gear and the sixth gear; and each gear is composed of relatively set limit bumps 2-3;
  • the brush rod has two positions relative to the brush cylinder, which are the first station and the second station; Station;
  • the composite locking part and the limit protrusion form a detachable buckle.
  • the brush head is stored in the sleeve and is close to the front opening; After aseptic treatment, assemble the cervical brush and keep the brush rod in this position. At this time, the brush head is stored in the sleeve, and the matching cap is used to close the front end of the sleeve, so as to ensure that the sterile brush head will not be damaged by the user before sampling. pollute;
  • the multi-level adjustment locking part and the limit protrusion form a detachable buckle.
  • the brush head can adjust the distance from the sleeve according to the distance required for sampling;
  • the sampling bottle used in conjunction with the cervical brush
  • the sampling bottle includes a bottle cap 6, a reagent bottle 7 and a suction cup base 8, and the coaxial thread of the bottle cap is installed at the opening of the reagent bottle for sealing and storage.
  • the suction cup base is made of silica gel, and is coaxially installed on the bottom end of the reagent bottle, so that the reagent bottle can be stably placed on the operating table without fear of the risk of tipping
  • the suction cup base includes a mounting part 8-1 and Suction cup 8-2, the upper surface of the suction cup is coaxially formed with a mounting part, and the mounting part is a hollow cylinder structure compatible with the reagent bottle;
  • the bottom of the reagent bottle is made into a conical structure 7-2, and a plurality of reinforcing scrapers 7-4 are evenly spaced along its circumferential direction on the inner wall of the conical structure;
  • each reinforced scraper protrudes from the inner wall of the bottom of the reagent bottle.
  • annular groove 4-4 is also formed on the outer wall of the sleeve front end of the cervical brush; and an annular groove is formed on the inner wall of the reagent bottle near the opening.
  • the matching convex ring, the ring groove structure of the sleeve and the built-in convex ring structure of the reagent bottle are perfectly matched to each other, and the sleeve is stable without tilting, so that the brush rod can be safely operated to achieve stable sample storage;
  • Both sides of the brush handle are symmetrically made with arc-shaped protrusions 1-2, which increase the rotation force point of the brush handle and make the rotation easier; during the sampling process, the operating specification is to rotate the brush handle 5 to 10 times to ensure the collection When a sufficient number of samples are obtained, in order to facilitate the operator to rotate the sampling brush for counting, a fine-toothed structure 1-1 is made on one of the arc-shaped protrusions of the brush handle to make the hand feel more prominent, and hand touch combined with visual counting More significantly, the cumulative number of rotations;
  • the brush head adopts cylindrical bristle distribution.
  • the connection between the top of the brush head and the plug post of the brush rod is designed with a cylindrical connection platform.
  • the bristles adopt three circles of bristle structure 3-1 with different lengths arranged radially.
  • the length of the bristles increases radially inward, and each layer of bristles touches the cervix.
  • the opening angle of the wall is different, which makes it easier to reach the cervix;
  • the cap is a flower-shaped cap, including a cap body whose structure is similar to that of a syringe needle cap.
  • the front end of the cap body is a cap opening 5-1, and the inner diameter of the cap opening is adapted to the outer diameter of the front end of the sleeve , to facilitate the coaxial insertion of the cap body at the front end of the sleeve;
  • a flower-shaped placement seat 5-2 is coaxially formed outside the cap body near the cap opening, so
  • the seat arm of the flower-shaped placement seat extends radially outward along the cap opening to the cap tail to form a flower pattern, which not only achieves a beautiful atmosphere, but also increases the cap placement area due to this flower-shaped structure, and realizes that the cervical brush can be vertical Easy to place and take;
  • the present invention also includes a method for sampling and storing samples of a self-collecting cervical cell sampler with adjustable length: comprising the following steps:
  • Step 1 Wash your hands before use, tear open the small packaging bag, and take out the cervical brush;
  • Step 2 Take off the cap, press both sides of the sleeve of the cervical brush with your thumb and forefinger, and pull it out, making sure that your hands cannot touch the bristles of the cervical brush;
  • Step 3 Take samples in a standing or lying position, insert the cervical brush into the vagina until the two wings of the sleeve stick to the labia, hold the sleeve with one hand, and push the brush rod with the other hand so that the bristles partly touch the cervix.
  • the hour hand rotates 5-7 weeks;
  • Step 4 After the rotation sampling is completed, pull the brush rod so that the bristle part is completely retracted into the sleeve;
  • Step 5 Pull back the sleeve to take out the cervical brush, screw the sleeve into the matching storage solution tube, push the brush rod to completely immerse the bristles in the storage solution, and rotate for 7-10 cycles to make the sampling brush cells fall out of the storage solution.
  • the sleeve of the cervical brush of the present invention will completely enter the vagina during sampling. At this time, the brush head is pushed out of the sleeve, and the length from the side wings to the top of the brush head is 7cm to 10cm, which is in line with the vaginal length data of ordinary people.
  • the brush head can fully contact the cervix; rotate the brush handle, and after the rotation and sampling are completed, pull the brush handle to completely retract the bristles into the sleeve; pull back the sleeve to take out the cervical brush, attach the sampling bottle to the operating table, and open the sampling bottle
  • Add the preservation solution into the reagent bottle connect the cervical brush with the reagent bottle stably, screw the sleeve into the matching preservation solution, push the brush rod to completely immerse the bristles in the preservation solution, and strengthen the bristles and the bottom of the reagent bottle Rotate the scraper for 7-10 cycles, so that the cervical cells fall into the preservation solution, then return the brush head, pull out the whole cervical brush, and discard it directly; there is no need to remove the brush head during the process, so as to avoid removing the brush before it dissolves into the cells The head may accidentally cause unnecessary pollution or shake off the cervical exfoliated cells that have been brushed.
  • the brush rod can be kept in the first position when the product leaves the factory, and the brush head is stored in the brush tube at this time, and the design of the flower-shaped cap ensures that the sterile brush head is not used before sampling.
  • the cervical brush can be placed vertically when used at the same time; the operator can independently send the sleeve of the cervical brush into the body when sampling, until the side of the sleeve is limited; at this time, the other hand is fully pushed in the direction of the body From the brush bar to the second station, the operator can select the appropriate gear to lock at the second station according to the actual situation.
  • the brush head With the brush handle, the brush head fully extends out of the brush barrel, and does not continue to protrude after reaching the cervix of the sampling site; Then gently rotate the brush handle in one direction with one hand, drive the brush rod and brush head to rotate at the sampling site to collect samples, count by hand touch, rotate 5 to 10 times in total, and complete the collection of cervical exfoliated cells; when storing samples, put the cervical brush as a whole Stable connection with the reagent bottle, the sleeve is screwed into the matching preservation solution, push the brush rod to completely immerse the bristles in the preservation solution, rotate for 7-10 cycles, so that the cervical cells fall out of the preservation solution, then return the brush head, pull out The whole cervical brush can be discarded directly; there is no need to remove the brush head during the process, so as to avoid unnecessary pollution caused by accidentally removing the brush head before dissolving the cells or shaking off the cervical exfoliated cells that have been brushed.

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Abstract

一种可调节长度的自采宫颈细胞取样器及取样、存样方法，包括宫颈刷，宫颈刷包括套筒(4)、刷杆(2)以及刷头(3)，刷杆(2)穿过套筒(4)，刷杆(2)前端安装刷头(3)，套筒(4)内中部设置限位凸起部，套筒外壁形成侧翼(4-2)，侧翼(4-2)将套筒(4)分为入体部分(4-3)和非入体部分(4-1)；入体部分(4-3)的套筒(4)外表面做光滑处理；非入体部分(4-1)的套筒(4)外周壁为棱柱结构；刷杆(2)包括杆体，杆体上沿前端指向后端方向依次形成复合卡位部(2-4)和多档调节锁止部(2-1)；刷杆(2)由复合卡位部(2-4)配合套筒(4)内的限位凸起部卡位；多档调节锁止部(2-1)可与套筒(4)内的限位凸起部形成锁止配合。取样器的宫颈刷取样方便、舒适度较高，可以根据实际取样距离多档位调节，且结合取样瓶的设计，大大提高了取样效率。

Description

可调节长度的自采宫颈细胞取样器及取样、存样方法 技术领域
本发明属于医疗检测技术领域，涉及宫颈刷技术，尤其是一种可调节长度的自采宫颈细胞取样器。
背景技术
临床上进行宫颈病变检查、HPV病毒检查等妇科检查时需要用到宫颈细胞采样刷，目前宫颈细胞采样大多是在医疗机构的临床科室进行，采用的医疗器械多数是简易的宫颈细胞采集器，其由刷头和细杆刷柄组成，刷头和刷杆可以同步转动、可拆卸。这种采样刷和采样方式的弊端在于，需要由扩阴器先对阴道扩张、将宫颈完全暴露在采样者视野中时才能进行采样，且宫颈细胞采样操作只能在医疗机构由专业医务人员进行。这种采样方法需要两种医疗器械配合使用，限制了采样效率、浪费了医用耗材，且无法照顾有隐私采样需求的个人患者；因此，需要开发一种可调节长度的自采宫颈细胞取样器及取样、存样方法。
通过检索未发现与本申请相关的专利文献。
发明内容
本发明的目的在于克服现有技术的不足之处，提供一种可调节长度的自采宫颈细胞取样器及取样、存样方法，该取样器的宫颈刷取样方便、舒适度较高，可以根据实际取样距离多档位调节，且结合取样瓶的设计，大大提高了取样效率。
本发明解决其技术问题是采取以下技术方案实现的：
一种可调节长度的自采宫颈细胞取样器，包括宫颈刷，所述宫颈刷包括套筒、刷杆以及刷头，所述套筒为两端开口的中空圆柱体结构，所述刷杆同轴穿过套筒设置，且刷杆前端同轴安装有刷头，所述套筒前端还同轴外套有帽子，所述套筒内中部设置有限位凸起部，套筒的外壁还形成有侧翼，所述侧翼将套筒分为入体部分和非入体部分；其中入体部分为侧翼至套筒前端的部分，且该部分的外表面做光滑处理；非入体部分则为侧翼至套筒后端的部分，该部分的套筒外周壁为棱形结构；
所述刷杆包括杆体，所述杆体的前端设置刷头塞柱；用于同轴连接刷头；所述杆体的后端设有刷柄；杆体上沿前端指向后端方向依次形成有复合卡位部和多档调节锁止部；所述刷杆向套筒后端的运动趋势由复合卡位部配合套筒内的限位凸起部卡位；多档调节锁止部可与套筒内的限位凸起部形成锁止配合；
所述复合卡位部包括沿杆体轴向方向相对设置的两组弹性构件，每组弹性构件均包括两个相对设置的弹性臂，且两个弹性臂之间形成卡位点，该卡位点与套筒的限位凸起部形成配合止动，且位于前端的弹性臂径向向外倾斜设置；位于后端的弹性臂端部制有中间限位档柱；且靠近该中间限位档柱位置的弹性臂外侧面制有后侧前推档位凸起；
所述多档调节锁止部包括沿杆体轴向方向均布间隔设置的多个档位，每个档位均由相对设置的限位凸点构成。
而且，还包括与宫颈刷配合使用的取样瓶，所述取样瓶包括瓶盖、试剂瓶以及吸盘底座，所述瓶盖同轴螺纹安装在试剂瓶的开口处；所述吸盘底座为硅胶材质制成，同轴安装在试剂瓶的底端。
而且，所述吸盘底座包括安装部以及吸盘，所述吸盘上表面同轴制有一安装部，该安装部为与试剂瓶相适配的中空圆柱体结构。
而且，所述套筒前端的外壁上还制有一环槽。
而且，所述试剂瓶靠近开口处的内壁上制有凸环，该凸环与套筒的环槽相适配。
而且，所述刷柄两侧对称制有圆弧形凸起，在刷柄的其中一个圆弧形凸起处制有细齿结构。
而且，所述刷头包括与刷头塞柱衔接的连接台，所述连接台上径向间隔设置有三圈不同长度的刷毛，每圈刷毛长度径向向内递增。
而且，所述帽子为花型帽子，包括帽体，所述帽体前端为帽口，帽口的内径与套筒前端外径相适配，在靠近帽口位置的帽体外部同轴制有一花型放置座，所述花型放置座的座臂沿帽口指向帽尾方向径向向外渐延形成花型。
而且，所述试剂瓶底部制成圆锥结构，且在该圆锥结构内壁上沿着其圆周方向均布间隔设有多根加强刮板；所述试剂瓶的瓶体下方轴向延伸出环形安装部，且圆锥结构位于环形安装部内侧。
而且，可调节长度的自采宫颈细胞取样器的取样、存样方法：包括如下步骤：
步骤一：使用前将双手洗净，撕开小包装袋，取出宫颈刷；
步骤二：将帽子取下，用大拇指和食指按压宫颈刷的套筒两侧，将其拔开，确保手不能碰到宫颈刷的刷毛部位；
步骤三：以站立或平躺的姿势取样，将宫颈刷插入阴道内直至套筒两翼贴于阴唇，用一只手捏住套筒，另一只手推动刷杆使刷毛部分接触宫颈口，顺时针旋转5-7周；
步骤四：旋转取样完毕后，拉动刷杆使刷毛部分完全缩回套筒；
步骤五：抽回套筒取出宫颈刷，将套筒旋拧到配套保存液管中，推动刷杆使刷毛完全浸 入保存液中，旋转7-10周，使采样刷细胞脱离落入保存液中。
本发明的优点和积极效果是：
本发明取样器的宫颈刷取样方便、舒适度较高，可以根据实际取样距离多档位调节，且结合取样瓶的设计，大大提高了取样效率。
附图说明
图1为本发明爆炸结构示意图；
图2为本发明立体图；
图3为本发明宫颈细胞转存状态示意图；
图4为本发明刷杆局部放大图；
图5为本发明试剂瓶结构示意图；
图6为本发明宫颈刷与取样瓶装配部放大图；
图7为本发明套筒与刷杆装配局部放大图。
具体实施方式
下面结合附图并通过具体实施例对本发明作进一步详述，以下实施例只是描述性的，不是限定性的，不能以此限定本发明的保护范围。
一种可调节长度的自采宫颈细胞取样器，包括宫颈刷，所述宫颈刷包括套筒4、刷杆2以及刷头3，所述套筒为两端开口的中空圆柱体结构，所述刷杆同轴穿过套筒设置，且刷杆前端同轴安装有刷头，所述套筒前端还同轴外套有帽子5，该帽子用于封闭套筒前端，起到保护刷头的作用；所述套筒内中部设置有限位凸起部；该限位凸起部为环形凸起，所述套筒的外壁还形成有侧翼4-2；
具体而言，在套筒中央位置设计了一圈(弧面或平面)侧翼，在套筒外周形成一个与刷杆垂直的弧面或平面，所述侧翼将套筒分为入体部分4-3和非入体部分4-1；其中入体部分为侧翼至套筒前端的部分，且该部分的外表面做光滑处理，由此减小刷杆穿入阴道的不适感，其长度为入体采样距离；非入体部分则为侧翼至套筒后端的部分，该部分的套筒外周壁为棱形结构，止转易握取，不放过任何体验细节感受；本实施例采用套筒材质选用符合医用使用要求的优质塑料，具体可参考已有同类产品；
上述侧翼的作用是采样时，对套筒深入体内的长度起到限位作用，避免因操作失误套筒进入人体过长而引发伤害，即控制前述的入体采样距离，具体距离范围遵循下述规范，侧翼入体部分的长度为4cm至6cm，刷头长度3cm至4cm，采样时入体部分的套筒会完全进入阴道内，此时将采样刷头推出套筒，侧翼到达刷头顶端的长度为7cm至10cm，这符合普通人的阴道长度数据，可以使刷头充分接触宫颈部位；
所述刷杆包括杆体，所述杆体的前端设置刷头塞柱2-5；该刷头塞柱用于同轴连接刷头； 所述杆体的后端设有刷柄1；杆体上沿前端指向后端方向依次形成有复合卡位部2-4和多档调节锁止部2-1；所述刷杆向套筒后端的运动趋势由复合卡位部配合套筒内的限位凸起部卡位；多档调节锁止部可与套筒内的限位凸起部形成锁止配合；刷杆材质为优质塑料，通过形成两端与杆体一体成型、中部悬空的条形部，使条形部具有弹性，进而在各条形部上形成复合卡位部和多档调节锁止部的结构；
所述复合卡位部包括沿杆体轴向方向相对设置的两组弹性构件，每组弹性构件均包括两个相对设置的弹性臂，且两个弹性臂之间形成卡位点2-6，该卡位点与套筒的限位凸起部形成配合止动，且位于前端的弹性臂2-4-2径向向外倾斜设置；在卡位时实现止回倒扣的作用，防止刷杆从套筒后端方向抽出；位于后端的弹性臂端部制有中间限位档柱2-4-3；且靠近该中间限位档柱位置的弹性臂外侧面制有后侧前推档位凸起2-4-1，所述中间限位档柱和后侧前推档位凸起的设置，使得推杆推出更加顺畅；
所述多档调节锁止部包括沿杆体轴向方向均布间隔设置的多个档位，多个档位沿前端指向后端方向分别为第一档位、第二档位、第三档位、第四档位、第五档位以及第六档位；且每个档位均由相对设置的限位凸点2-3构成；
具体地，刷杆具有两个相对于刷筒的位置，分别为第一工位、第二工位；所述复合卡位部为第一工位，所述多档调节锁止部为第二工位；
其中，处于第一工位时，复合卡位部与限位凸起部形成可拉脱扣合，此时，刷头收纳于套筒内靠近前开口；一般采样刷生产厂家装配出厂时，进行无菌处理后将宫颈刷装配好，保持刷杆处于此工位，此时刷头收在套筒内，并且配套帽子，实现套筒前端封闭，保证用户在采样前，无菌刷头不被污染；
处于第二工位时，多档调节锁止部与限位凸起部形成可拉脱扣合，此时，刷头可以根据取样所需距离进行调节伸出套筒的距离；
此外，还包括一个与宫颈刷配合使用的取样瓶，所述取样瓶包括瓶盖6、试剂瓶7以及吸盘底座8，所述瓶盖同轴螺纹安装在试剂瓶的开口处，用于密封存取样品；所述吸盘底座为硅胶材质制成，同轴安装在试剂瓶的底端，便于将试剂瓶稳定放置在操作台上，不惧倾倒风险；所述吸盘底座包括安装部8-1以及吸盘8-2，所述吸盘上表面同轴制有一安装部，该安装部为与试剂瓶相适配的中空圆柱体结构；
在本发明的具体实施中，所述试剂瓶底部制成圆锥结构7-2，且在该圆锥结构内壁上沿着其圆周方向均布间隔设有多根加强刮板7-4；实施例设置四根，且每根加强刮板均凸出试剂瓶底部内壁，在存样时，刷头的毛刷转动，加强刮板可以刮取毛刷上的宫颈细胞；且为了试剂瓶与吸盘底座更好的安装，所述试剂瓶的瓶体下方轴向延伸出环形安装部7-3，且圆锥 结构位于环形安装部内侧；
进一步，为了使得宫颈刷更好的转移保存样品，在所述宫颈刷的套筒前端的外壁上还制有一环槽4-4；且所述试剂瓶靠近开口处的内壁上制有一与环槽相适配的凸环，套筒环槽结构与试剂瓶内置凸环结构，完美匹配相互卡位，稳固套筒无倾斜，可以安心操作刷杆，实现稳固存样；
所述刷柄两侧对称制有圆弧形凸起1-2，增加刷柄的增加旋转着力点，旋转更轻松；采样过程中，操作规范是将刷杆旋转5～10圈，以确保采集到足够数量的样本，采样时为了便于操作者进行旋转采样刷计数，在刷柄的其中一个圆弧形凸起处制有细齿结构1-1，使手感更突出，手触结合目视计数更加显著，累计旋转圈数；
所述刷头采用圆柱形刷毛分布。刷头顶端与刷杆塞柱的衔接处，设计圆柱形连接台，所述刷毛采用径向设置的三圈不同长度的刷毛结构3-1，刷毛长度径向向内递增，每层毛接触宫颈壁张开角度不同，更易接触到宫颈口；
所述帽子为花型帽子，包括帽体，该帽体结构与注射器针帽相类似，所述帽体前端为帽口5-1，所述帽口的内径与套筒前端外径相适配，便于帽体同轴插装在套筒前端；为了使得宫颈刷可以更好的竖直放置以及取用，在靠近帽口位置的帽体外部同轴制有一花型放置座5-2，所述花型放置座的座臂沿帽口指向帽尾方向径向向外渐延形成花型，不仅达到美观大气，而且由于这种花型结构，增大了帽子放置面积，实现宫颈刷可以竖直放置，拿取方便；
本发明还包括一种可调节长度的自采宫颈细胞取样器的取样、存样方法：包括如下步骤：
步骤一：使用前将双手洗净，撕开小包装袋，取出宫颈刷；
步骤二：将帽子取下，用你的大拇指和食指按压宫颈刷的套筒两侧，将其拔开，确保你的手不能碰到宫颈刷的刷毛部位；
步骤三：以站立或平躺的姿势取样，将宫颈刷插入阴道内直至套筒两翼贴于阴唇，用一只手捏住套筒，另一只手推动刷杆使刷毛部分接触宫颈口，顺时针旋转5-7周；
步骤四：旋转取样完毕后，拉动刷杆使刷毛部分完全缩回套筒；
步骤五：抽回套筒取出宫颈刷，套筒旋拧到配套保存液管中，推动刷杆使刷毛完全浸入保存液中，旋转7-10周，使采样刷细胞脱离落入保存液中。
本发明的宫颈刷在采样时入体部分的套筒会完全进入阴道内，此时将刷头推出套筒，侧翼到达刷头顶端的长度为7cm至10cm，这符合普通人的阴道长度数据，可以使刷头充分接触宫颈部位；旋转刷柄，旋转取样完毕后，拉动刷杆使刷毛部分完全缩回套筒；抽回套筒取出宫颈刷，将取样瓶吸附在操作台上，打开取样瓶的瓶盖，在试剂瓶内加入保存液，将宫颈刷整体与试剂瓶稳定连接，套筒旋拧到配套保存液中，推动刷杆使刷毛完全浸入保存液中，刷毛与试剂瓶底部的加强刮板，旋转7-10周，使宫颈细胞脱离落入保存液中，然后退回刷头， 拔离宫颈刷整体，直接丢弃；过程中无需取下刷头，避免因溶入细胞前取下刷头不慎造成不必要污染或震落已经刷取的宫颈脱落细胞。
通过采取上述技术方案，产品出厂时可使刷杆保持处于第一工位，此时刷头收在刷筒内，且通过花型帽子的设计，保证使用者在采样前，无菌刷头不被污染，同时使用时可以竖直放置本宫颈刷；操作者在采样时，能够独立将宫颈刷的套筒送入体内，直至套筒侧翼被限位；此时另一手向体内的方向充分推动刷杆至第二工位，操作者可以根据实际情况在第二工位选择合适的档位锁止，配合刷柄，刷头完全伸出刷筒，到达采样部位宫颈后不再继续前伸；然后单手轻轻单方向旋转刷柄，带动刷杆、刷头在采样部位转动采集样本，通过手触进行计数，共转动5～10次，完成宫颈脱落细胞采集；存样时，将宫颈刷整体与试剂瓶稳定连接，套筒旋拧到配套保存液中，推动刷杆使刷毛完全浸入保存液中，旋转7-10周，使宫颈细胞脱离落入保存液中，然后退回刷头，拔离宫颈刷整体，直接丢弃；过程中无需取下刷头，避免因溶入细胞前取下刷头不慎造成不必要污染或震落已经刷取的宫颈脱落细胞。
尽管为说明目的公开了本发明的实施例和附图，但是本领域的技术人员可以理解：在不脱离本发明及所附权利要求的精神和范围内，各种替换、变化和修改都是可能的，因此，本发明的范围不局限于实施例和附图所公开的内容。

Claims (10)

  1. 一种可调节长度的自采宫颈细胞取样器，包括宫颈刷，所述宫颈刷包括套筒、刷杆以及刷头，所述套筒为两端开口的中空圆柱体结构，所述刷杆同轴穿过套筒设置，且刷杆前端同轴安装有刷头，所述套筒前端还同轴外套有帽子，所述套筒内中部设置有限位凸起部，套筒的外壁还形成有侧翼，其特征在于：所述侧翼将套筒分为入体部分和非入体部分；其中入体部分为侧翼至套筒前端的部分，且该部分的外表面做光滑处理；非入体部分则为侧翼至套筒后端的部分，该部分的套筒外周壁为棱形结构；
    所述刷杆包括杆体，所述杆体的前端设置刷头塞柱；用于同轴连接刷头；所述杆体的后端设有刷柄；杆体上沿前端指向后端方向依次形成有复合卡位部和多档调节锁止部；所述刷杆向套筒后端的运动趋势由复合卡位部配合套筒内的限位凸起部卡位；多档调节锁止部可与套筒内的限位凸起部形成锁止配合；
    所述复合卡位部包括沿杆体轴向方向相对设置的两组弹性构件，每组弹性构件均包括两个相对设置的弹性臂，且两个弹性臂之间形成卡位点，该卡位点与套筒的限位凸起部形成配合止动，且位于前端的弹性臂径向向外倾斜设置；位于后端的弹性臂端部制有中间限位档柱；且靠近该中间限位档柱位置的弹性臂外侧面制有后侧前推档位凸起；
    所述多档调节锁止部包括沿杆体轴向方向均布间隔设置的多个档位，每个档位均由相对设置的限位凸点构成。
  2. 根据权利要求1所述的可调节长度的自采宫颈细胞取样器，其特征在于：还包括与宫颈刷配合使用的取样瓶，所述取样瓶包括瓶盖、试剂瓶以及吸盘底座，所述瓶盖同轴螺纹安装在试剂瓶的开口处；所述吸盘底座为硅胶材质制成，同轴安装在试剂瓶的底端。
  3. 根据权利要求2所述的可调节长度的自采宫颈细胞取样器，其特征在于：所述吸盘底座包括安装部以及吸盘，所述吸盘上表面同轴制有一安装部，该安装部为与试剂瓶相适配的中空圆柱体结构。
  4. 根据权利要求1所述的可调节长度的自采宫颈细胞取样器，其特征在于：所述套筒前端的外壁上还制有一环槽。
  5. 根据权利要求2所述的可调节长度的自采宫颈细胞取样器，其特征在于：所述试剂瓶靠近开口处的内壁上制有凸环，该凸环与套筒的环槽相适配。
  6. 根据权利要求1所述的可调节长度的自采宫颈细胞取样器，其特征在于：所述刷柄两侧对称制有圆弧形凸起，在刷柄的其中一个圆弧形凸起处制有细齿结构。
  7. 根据权利要求1所述的可调节长度的自采宫颈细胞取样器，其特征在于：所述刷头包 括与刷头塞柱衔接的连接台，所述连接台上径向间隔设置有三圈不同长度的刷毛，每圈刷毛长度径向向内递增。
  8. 根据权利要求1所述的可调节长度的自采宫颈细胞取样器，其特征在于：所述帽子为花型帽子，包括帽体，所述帽体前端为帽口，帽口的内径与套筒前端外径相适配，在靠近帽口位置的帽体外部同轴制有一花型放置座，所述花型放置座的座臂沿帽口指向帽尾方向径向向外渐延形成花型。
  9. 根据权利要求2所述的可调节长度的自采宫颈细胞取样器，其特征在于：所述试剂瓶底部制成圆锥结构，且在该圆锥结构内壁上沿着其圆周方向均布间隔设有多根加强刮板；所述试剂瓶的瓶体下方轴向延伸出环形安装部，且圆锥结构位于环形安装部内侧。
  10. 根据权利要求1-9任意一项所述的可调节长度的自采宫颈细胞取样器的取样、存样方法：其特征在于：包括如下步骤：
    步骤一：使用前将双手洗净，撕开小包装袋，取出宫颈刷；
    步骤二：将帽子取下，用大拇指和食指按压宫颈刷的套筒两侧，将其拔开，确保手不能碰到宫颈刷的刷毛部位；
    步骤三：以站立或平躺的姿势取样，将宫颈刷插入阴道内直至套筒两翼贴于阴唇，用一只手捏住套筒，另一只手推动刷杆使刷毛部分接触宫颈口，顺时针旋转5-7周；
    步骤四：旋转取样完毕后，拉动刷杆使刷毛部分完全缩回套筒；
    步骤五：抽回套筒取出宫颈刷，将套筒旋拧到配套保存液管中，推动刷杆使刷毛完全浸入保存液中，旋转7-10周，使采样刷细胞脱离落入保存液中。
PCT/CN2022/129604 2022-02-16 2022-11-03 可调节长度的自采宫颈细胞取样器及取样、存样方法 WO2023155486A1 (zh)

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