WO2020238036A1 - 唾液采检装置 - Google Patents

唾液采检装置 Download PDF

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Publication number
WO2020238036A1
WO2020238036A1 PCT/CN2019/116294 CN2019116294W WO2020238036A1 WO 2020238036 A1 WO2020238036 A1 WO 2020238036A1 CN 2019116294 W CN2019116294 W CN 2019116294W WO 2020238036 A1 WO2020238036 A1 WO 2020238036A1
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WIPO (PCT)
Prior art keywords
sampling
liquid storage
handle
saliva
cylinder
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PCT/CN2019/116294
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English (en)
French (fr)
Inventor
万志强
李泽江
贾文刚
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万华普曼生物工程有限公司
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Application filed by 万华普曼生物工程有限公司 filed Critical 万华普曼生物工程有限公司
Publication of WO2020238036A1 publication Critical patent/WO2020238036A1/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
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B10/0051—Devices for taking samples of body liquids for taking saliva or sputum samples

Definitions

  • the invention relates to the field of in vitro diagnostics, and more specifically, to a saliva sampling and testing device.
  • the saliva sampling and testing device in the prior art is usually disposable, and it can only perform one saliva sample detection after one saliva collection.
  • the sample In actual operation, for example, when it is necessary to detect whether the subject is taking drugs, when the first test result of the sample is positive, the sample usually needs to be retested to ensure the accuracy of the test result. Therefore, the aforementioned saliva sampling device for one collection corresponding to one detection cannot meet the need for re-examination.
  • the saliva sampling device in the prior art often fails to indicate whether the collected sample volume meets the requirements, so that the subject cannot grasp the appropriate collection volume.
  • the purpose of the present invention is to overcome or at least alleviate the above-mentioned shortcomings in the prior art, and provide a saliva sampling device that can provide retest samples.
  • the present invention provides a saliva sampling and testing device, which includes a detection container, a sampling handle and a sampling body.
  • the device also includes a liquid storage component,
  • the liquid storage component includes liquid storage,
  • the liquid storage and the sampling body are used for absorbing saliva samples
  • the sampling handle is cylindrical, and the sampling body is fixed to one end of the sampling handle and extends at least partially out of the sampling handle,
  • the liquid storage assembly can extend into the inner cavity of the sampling handle and is detachably fixedly installed and connected with the sampling handle. When the liquid storage assembly and the sampling handle are fixedly installed, the liquid storage and the sampling handle Sample body contact,
  • the sampling handle can extend into the inner cavity of the detection container, and make the sampling body squeeze the detection container to release the saliva sample.
  • the sampling handle includes a first cylinder and a second cylinder that are sequentially connected in the axial direction, and the inner diameter of the first cylinder is larger than the inner diameter of the second cylinder,
  • the sampling body is fixed and partially contained in the inner cavity of the first cylinder, and the liquid storage is at least partially contained in the inner cavity of the second cylinder.
  • the sampling handle further includes a third cylinder connected to the second cylinder in the axial direction, and the inner diameter of the third cylinder is larger than the inner diameter of the second cylinder,
  • the liquid storage assembly can be hermetically assembled with the inner wall of the third cylinder.
  • the sampling handle further includes a locking cylinder, and an outer peripheral wall of the locking cylinder has a locking structure that is detachably connected to the detection container.
  • the sampling handle further includes a hand-held cylinder connected to the locking cylinder in the axial direction and located at the other end of the sampling handle, and the outer diameter of the hand-held cylinder is larger than that of the lock.
  • the outer diameter of the closing cylinder thereby forming an annular stop wall between the hand-held cylinder and the locking cylinder.
  • the liquid storage assembly further includes a liquid storage handle, and the liquid storage is fixed to the liquid storage handle,
  • the liquid storage handle includes a chuck, the outer diameter of the chuck is greater than the inner diameter of the locking barrel but smaller than the inner diameter of the hand-held barrel,
  • the outer periphery of the chuck has a gap
  • the inner wall of the hand-held barrel has a stop bar that matches with the gap
  • the stop bar and the stop wall limit the chuck on both sides of the axial direction of the chuck.
  • the liquid storage assembly further includes a connecting barrel connected to the chuck, the chuck having an opening communicating with the inner cavity of the connecting barrel,
  • the inner wall of the connecting barrel has a bayonet, so that the connecting barrel can cooperate with a disassembly tool to controlly install and/or disassemble the sampling handle.
  • the saliva sampling device further includes a buckle, the buckle is used as the disassembly tool to assist the installation and/or disassembly of the liquid storage assembly and the sampling handle,
  • the buckle includes a cylindrical base and a leg connected to the base and extending in an axial direction, the leg having a hook,
  • the leg portion When the buckle partially extends into the connecting barrel, the leg portion is squeezed by the wall of the connecting barrel, and the hook portion extends into the bayonet so that the buckle can be detached It is fixedly connected with the liquid storage handle.
  • the device further includes a sealing film, and the sealing film is hermetically fixed on the other end of the sampling handle away from the sampling body.
  • the liquid storage assembly further includes an indicator that can change color after being wetted, and the indicator is installed at an end of the liquid storage that is away from the sampling body.
  • test samples can be provided to realize the functions of liquid storage and retesting.
  • Fig. 1 is an exploded schematic diagram of a saliva sampling device according to an embodiment of the present invention.
  • Fig. 2 is an axial sectional view of the saliva sampling device in Fig. 1 after being assembled.
  • Fig. 3 is an exploded schematic diagram of a part of the saliva sampling device in Fig. 1.
  • Fig. 4 is a cross-sectional view of Fig. 3 along the axial direction.
  • 5 and 6 are schematic diagrams of disassembling and disassembling the liquid storage handle using a buckle according to an embodiment of the present invention.
  • test container 400 test paper jam; 401 test paper slot; 402 support part; 500 liquid storage; 600 sampling body; 700 indicator; 800 sealing film;
  • A represents the axial direction of the saliva sampling device
  • R represents the radial direction of the saliva sampling device.
  • the direction indicated by arrow D is downward, and the opposite is upward.
  • the saliva sampling and inspection device includes a liquid storage handle 100, a sampling handle 200, a detection container 300, a test paper jam 400, a liquid storage 500, a sampling body 600, an indicator 700, a sealing film 800, a buckle 900, and a A sealing ring S1 and a second sealing ring S2.
  • the liquid storage handle 100, the liquid storage 500, the indicator 700 and the first sealing ring S1 are assembled together to form a liquid storage assembly.
  • sampling handle 200, the sampling body 600, the second sealing ring S2 and the above-mentioned liquid storage assembly are assembled together to form a sampling assembly.
  • the liquid storage 500 and the sampling body 600 are both composed of highly absorbent fibers and compressed into a cylindrical shape.
  • the liquid storage handle 100 functions as a support in the liquid storage assembly, and is used to fix the liquid storage 500.
  • the liquid storage handle 100 includes a chuck 101, a connecting barrel 102, and a fixing barrel 103 that are sequentially connected in the axial direction A.
  • the chuck 101 is ring-shaped, and its middle through hole is connected to the inner cavity of the connecting cylinder 102 for passing the buckle 900 described below during disassembly and assembly.
  • the outer circumference of the chuck 101 has two radially symmetrical notches 1011, which are used to limit the chuck 101 in the axial direction when the liquid storage handle 100 is mounted to the sampling handle 200, which will be further described below.
  • the outer diameter of the connecting barrel 102 is smaller than the outer diameter of the chuck 101.
  • the peripheral wall of the connecting cylinder 102 has two radially symmetrical bayonet openings 1021 for fixing the buckle 900 described below.
  • the fixed cylinder 103 is substantially cap-shaped with an open end, and its inner cavity is used for fixing the liquid storage 500.
  • the outer peripheral wall of the fixed cylinder 103 has an annular recessed portion recessed inward in the radial direction, and the first seal ring S1 is installed in the recessed portion.
  • the indicator 700 is connected to one end of the liquid storage 500 in the axial direction A.
  • the indicator 700 is made of water-absorbing materials.
  • the indicator 700 is a color-changing test paper with different colors before and after absorbing water.
  • the indicator 700 wraps around an axial end of the liquid storage 500.
  • one end of the liquid storage 500 to which the indicator 700 is attached is fixed to the liquid storage fixing ring 103 by means of glue dispensing.
  • the sampling handle 200 functions as a support in the sampling assembly, and is used to fix the sampling body 600, the second sealing ring S2 and the liquid storage assembly.
  • the sampling handle 200 is in the shape of a hollow cylinder, and in the axial direction A, it sequentially includes a first cylinder 201, a second cylinder 202, a third cylinder 203, a locking cylinder 204, and a hand-held cylinder 205 with all cavities in communication.
  • the first cylinder 201 is substantially cap-shaped, and its inner cavity is used to accommodate the sampling body 600.
  • the sampling body 600 protrudes from the first cylinder 201 in a natural state, that is, when the sampling assembly is not assembled into the detection container 300, the axial length of the sampling body 600 is greater than the axial length of the first cylinder 201, and the subject can The protruding end of the sampling body 600 is placed in the mouth to collect saliva.
  • the inner cavity of the second cylinder 202 is used to contain the liquid 500.
  • the inner diameter of the second cylinder 202 is smaller than the inner diameter of the first cylinder 201, which enables the sampling body 600 to be fixed and restricted in the axial direction A by the end of the first cylinder 201. This will be explained below. It will be easier to understand when deformed.
  • the third cylinder 203 is used to accommodate the fixed cylinder 103 and closely cooperate with it to form an end seal structure.
  • the inner diameter of the third cylinder 203 is slightly smaller than the outer diameter of the first sealing ring S1, so that the first sealing ring S1 can be sealed Ground fills the radial gap between the fixed cylinder 103 and the third cylinder 203.
  • the inner diameter of the third cylinder 203 is larger than the inner diameter of the second cylinder 202.
  • the outer peripheral wall of the locking cylinder 204 has a locking structure for coupling with the locking structure of the inner peripheral wall of the detection container 300 described below, so as to realize the detachable connection between the sampling handle 200 and the detection container 300.
  • the locking structure of the outer peripheral wall of the locking cylinder 204 and the locking structure of the inner peripheral wall of the detection container 300 are both threaded structures.
  • the positioning portion 2041 protruding downward.
  • the positioning portion 2041 is used to abut against the axial end of the test paper jam 400 described below, so as to realize the tight fit of the sampling handle 200 and the test paper jam 400 in the detection container 300.
  • the inner diameter of the peripheral wall of the hand barrel 205 is larger than the inner diameter of the peripheral wall of the locking barrel 204.
  • an annular stop wall 2052 connecting the two is formed between the hand barrel 205 and the locking barrel 204.
  • the second sealing ring S2 can be sleeved on the outer periphery of the locking cylinder 204 and abut against the stop wall 2052 to obtain a limit in the axial direction A.
  • the stop wall 2052 limits the chuck 101 of the liquid storage handle 100 in the axial direction A.
  • the liquid storage handle 100 and the sampling handle are described below. The assembly relationship of the 200 will be further explained.
  • the locking cylinder 204 will be contained in the inner cavity of the detection container 300, and the hand-held cylinder 205 will expose the detection container 300 to facilitate the disassembly and assembly of the sampling handle 200.
  • the liquid storage assembly extends into the sampling handle 200 from the upper part of the sampling handle 200, so that the notch 1011 is aligned with the stop bar 2051 in the circumferential direction, and the chuck 101 enters the inner cavity of the handheld barrel 205 and makes the chuck 101 abut Lean against the stop wall 2052.
  • the distance from the end surface of the stop bar 2051 located below D to the upper end surface of the stop wall 2052 is equal to the thickness of the chuck 101 in the axial direction A. Then, the chuck is rotated circumferentially to make the notch 1011 and the stop bar 2051 stagger in the circumferential direction, so the notch 1011 and the stop bar 2051 limit the chuck 101 on both sides of the axial direction A.
  • the liquid storage handle 100 can be operated by means of the buckle 900.
  • the buckle 900 includes a cylindrical base 901 and two radially symmetrical legs 902 extending in the axial direction and connected to the base 901. The end portion of the leg portion 902 away from the base portion 901 has a hook portion 9021 protruding radially outward.
  • the outer peripheral end surfaces of the two legs 902 are coplanar with the outer peripheral surface of the base portion 901, and the outer diameter of the base portion 901 (excluding the ridge portion 9011) is equal to the inner diameter of the connecting cylinder 102, The radial distance between the outer circumferential surfaces of the two hooks 9021 is greater than the inner diameter of the connecting cylinder 102.
  • the outer peripheral wall of the base 901 has a plurality of circumferentially distributed ridges extending in the axial direction, thereby forming a ridge portion 9011.
  • the surface of the ridge portion 9011 is uneven and has a large friction coefficient, so that the ridge portion can be grasped.
  • the 9011 is easier to operate when the buckle 900 is rotated in the circumferential direction.
  • the buckle 900 Extend the buckle 900 into the inner cavity of the connecting cylinder 102 with the legs 902 facing inward. At this time, the two hooks 9021 are pressed by the inner wall of the connecting cylinder 102 to move closer to each other, so that the two legs 902 are directed radially. Elastic deformation occurs inside. Circumferentially align the hook portion 9021 into the bayonet 1021. At this time, the leg portion 902 returns to its original shape or at least reduces the amount of deformation to the radially outer side. Positioned within 102.
  • the liquid storage 500 contacts the sampling body 600 to ensure that the saliva absorbed by the sampling body 600 can be transferred to the liquid storage 500 for storage.
  • the sealing film 800 is hermetically connected to the axial end of the handheld barrel 205.
  • the sealing film 800 is, for example, tin foil paper that is easy to tear.
  • the operator can tear off the sealing film 800 and take the liquid storage assembly out of the sampling handle 200 by means of the buckle 900.
  • the buckle 900 may not be configured in the kit of the saliva sampling device.
  • the buckle 900 is only provided to the assembler before the device leaves the factory and the operator during the re-inspection, and the buckle 900 can be reused. Therefore, it is difficult for other personnel to take out the liquid storage assembly from the sampling handle 200 without using other tools, which helps to control the quality of the detection process.
  • the detection container 300 has a cylindrical shape with an open end.
  • the middle part of the inner bottom surface of the detection container 300 protrudes toward the opening to form a boss 301 (refer to FIG. 2 ), thereby defining an annular groove 302 on the outer periphery of the boss 301.
  • the test paper stopper 400 has a cylindrical shape with open ends, and can be placed in the test container 300 close to the inner wall of the test container 300.
  • the outer peripheral wall of the test paper jam 400 defines a plurality of test paper slots 401 for storing test papers (refer to FIG. 3).
  • One end of the test paper jam 400 is axially protrudingly provided with a plurality of supporting parts 402. In other words, one end of the test paper jam 400 is not flush in the axial direction.
  • the test paper jam 400 is placed in the detection container 300 with the support portion 402 facing inward.
  • the support portion 402 will abut against the bottom of the annular groove 302 in the axial direction, and the annular groove 302 has an unsuitable test paper jam in the circumferential direction.
  • the areas filled by the plug 400 provide space for the saliva sample to flow.
  • the inner diameter of the test paper jam 400 is equal to or slightly larger than the outer diameter of the third cylinder 203 and the outer diameter of the first cylinder 201.
  • the third tube 203, the second tube 202, and the first tube 201 of the sampling handle 200 are housed on the inner peripheral side of the test paper stopper 400, and the sampling body 600 contacts the boss 301 and Squeeze with the boss 301 to compress the sample body 600 in the axial direction.
  • the saliva sample absorbed in the sample body 600 is squeezed and flows out.
  • the saliva sample flows through the annular groove 302 and contacts the test paper cartridge 400 stored in it.
  • the test paper is tested to be tested.
  • the side wall of the detection container 300 is transparent, so that the operator can easily observe the change of the detection test paper through the detection container 300.
  • the liquid storage 500 When the sample body 600 is compressed, due to the axial limit effect of the wall of the axial end of the first cylinder 201 on the sample body 600, the liquid storage 500 will hardly be affected and deformed. The saliva sample will not flow out. Therefore, after the saliva sample stored in the sample body 600 completes one test, the saliva sample stored in the liquid storage 500 can also be used for the next test.
  • the liquid storage assembly is taken out with the aid of the buckle 900, and then, for example, the liquid storage assembly is placed in the re-inspection container and the saliva sample stored in the liquid storage 500 is squeezed out to form Perform a re-inspection.
  • the sampling assembly of the present invention stores the saliva samples collected at one time in the separable sampling body 600 and the liquid storage 500 respectively, and through reasonable structural design, the operation process of taking the saliva samples in the sampling body 600 is different. It will affect the saliva sample in the liquid storage 500.
  • the color change of the indicator 700 can simply and clearly indicate whether the sampling amount meets the requirements, and improve the efficiency of the sampling process.
  • the sealing film 800 is broken after being torn, and the liquid storage handle 100 needs to be removed from the sampling handle 200 with the help of tools such as the buckle 900.
  • the above arrangement can prevent the liquid storage assembly from being taken out in an undesired situation, for example When testing whether the subject is taking drugs or not, when the first test result of the sample is positive and the saliva sample in the liquid storage 500 needs to be re-examined, it is not hoped that irrelevant personnel will take out or even replace the liquid storage 500 in advance and interfere with the re-examination result.
  • the number of notches 1011 and the number of stop bars 2051 are not limited to two, only the notches 1011 and the stop bars 2051 can be matched in the circumferential direction; and when the number of notches 1011 and the stop bars 2051 are multiple, they It does not have to be evenly distributed or radially symmetrical in the circumferential direction.
  • the number of bayonet 1021 and the number of legs 902 is not limited to two, only the bayonet 1021 and the leg 902 can fit in the circumferential direction; and when the number of bayonet 1021 and the leg 902 is multiple At the same time, they do not have to be evenly distributed in the circumferential direction.
  • the present invention does not limit the specific size and shape of the indicator 700, and the indicator 700 does not have to be installed close to the end of the liquid storage 500. It only needs to satisfy that the position of the indicator 700 can indicate a sufficient amount of saliva samples, Moreover, the operator can observe the color change of the indicator 700 through the sampling handle 200.
  • the sampling handle 200 is transparent, or at least at the axial position of the fixed indicator 700, the sampling handle 200 is transparent.

Abstract

一种唾液采检装置，包括检测容器(300)、采样手柄(200)、采样体(600)和储液组件，储液组件包括储液体(500)，储液体(500)和采样体(600)用于吸收唾液样本，采样手柄(200)呈筒形，采样体(600)固定于采样手柄(200)的一个端部并至少部分地伸出采样手柄(200)，储液组件能够伸入采样手柄(200)的内腔并与采样手柄(200)能拆卸地固定安装连接，当储液组件与采样手柄(200)固定安装后，储液体(500)和采样体(600)接触，采样手柄(200)能够伸入检测容器(300)的内腔，并使采样体(600)挤压检测容器(300)以释放唾液样本。根据唾液采检装置，通过一次采集过程，能够提供两次的检验样本，实现储液和复检的功能。

Description

唾液采检装置
相关申请的引用
本发明要求2019年5月31日在中国提交的，名称为“唾液采检装置”、申请号为201910468439.X的发明专利申请的优先权，该申请的全部内容通过引用并入本文。
技术领域
本发明涉及体外诊断领域，更具体地，涉及一种唾液采检装置。
背景技术
现有技术中的唾液采检装置通常是一次性的，其采集一次唾液后只能对应完成一次唾液样本的检测。而在实际操作中，例如需要检测被试者是否吸食毒品时，当样本的首次检测结果为阳性时，通常需要对样本进行复检以保证检测结果的准确性。因此上述的一次采集对应一次检测的唾液采检装置不能满足复检需求。
此外，现有技术中的唾液采检装置往往不能提示所采集的样本量是否符合需求，使被试者不能掌握合适的采集量。
发明内容
本发明的目的在于克服或至少减轻上述现有技术存在的不足，提供一种能提供复检样本的唾液采检装置。
本发明提供一种唾液采检装置，其包括检测容器、采样手柄和采样体，所述装置还包括储液组件，
所述储液组件包括储液体，
所述储液体和所述采样体用于吸收唾液样本，
所述采样手柄呈筒形，所述采样体固定于所述采样手柄的一个端部并至少部分地伸出所述采样手柄，
所述储液组件能够伸入所述采样手柄的内腔并与所述采样手柄能拆卸地固定安装连接，当所述储液组件与所述采样手柄固定安装后，所述储液体和所述采样体接触，
所述采样手柄能够伸入所述检测容器的内腔，并使所述采样体挤压所述检测容器以释放所述唾液样本。
在至少一个实施方式中，所述采样手柄包括在轴向上依次相连的第一筒和第二筒，所述第一筒的内径大于所述第二筒的内径，
所述采样体固定并部分地收容于所述第一筒的内腔，所述储液体至少部分地收容于所述第二筒的内腔。
在至少一个实施方式中，所述采样手柄还包括第三筒，所述第三筒在轴向上与所述第二筒相连，所述第三筒的内径大于所述第二筒的内径，所述储液组件能够与所述第三筒的内壁密封地装配。
在至少一个实施方式中，所述采样手柄还包括锁闭筒，所述锁闭筒的外周壁具有与所述检测容器能拆卸地连接的锁闭结构。
在至少一个实施方式中，所述采样手柄还包括在轴向上与所述锁闭筒连接且位于所述采样手柄的另一个端部的手持筒，所述手持筒的外径大于所述锁闭筒的外径，从而在所述手持筒和所述锁闭筒之间形成环形的止挡壁。
在至少一个实施方式中，所述储液组件还包括储液手柄，所述储液体固定于所述储液手柄，
所述储液手柄包括卡盘，所述卡盘的外径大于所述锁闭筒的内径而小于所述手持筒的内径，
所述卡盘的外周部具有缺口，所述手持筒的内壁具有与所述缺口配合的 挡条，
当所述卡盘安装到所述手持筒的内腔后，所述挡条和所述止挡壁在所述卡盘的轴向两侧对所述卡盘限位。
在至少一个实施方式中，所述储液组件还包括与所述卡盘相连的连接筒，所述卡盘具有与所述连接筒的内腔相通的开口，
所述连接筒的内壁具有卡口，使得所述连接筒能与拆装工具配合而受控地与所述采样手柄安装和/或拆卸。
在至少一个实施方式中，所述唾液采检装置还包括卡扣，所述卡扣用作所述拆装工具以辅助所述储液组件与所述采样手柄的安装和/或拆卸，
所述卡扣包括柱状的基部和连接于所述基部且沿轴向延伸的腿部，所述腿部具有勾部，
当所述卡扣部分地伸入所述连接筒内时，所述腿部受到所述连接筒的壁的挤压，所述勾部伸入所述卡口，使得所述卡扣能拆卸地与所述储液手柄固定连接。
在至少一个实施方式中，所述装置还包括密封膜，所述密封膜密封地固定在所述采样手柄的远离所述采样体的另一个端部。
在至少一个实施方式中，所述储液组件还包括润湿后能够变色的指示件，所述指示件安装于所述储液体的远离所述采样体的端部。
根据本发明的唾液采检装置，通过一次采集过程，能够提供两次的检验样本，实现储液和复检的功能。
附图说明
图1是根据本发明的一个实施方式的唾液采检装置的分解示意图。
图2是图1中的唾液采检装置在完成装配后的沿轴向的剖视图。
图3是图1中的唾液采检装置的部分的分解示意图。
图4是图3的沿轴向的剖视图。
图5和图6是根据本发明的一个实施方式的使用卡扣拆装储液手柄的示意图。
附图标记说明
100 储液手柄；101 卡盘；1011 缺口；102 连接筒；1021 卡口；103 固定筒；
200 采样手柄；201 第一筒；202 第二筒；203 第三筒；204 锁闭筒；2041 定位部；205 手持筒；2051 挡条；2052 止挡壁；
300 检测容器；400 试纸卡塞；401 试纸槽；402 支撑部；500 储液体；600 采样体；700 指示件；800 密封膜；
900 卡扣；901 基部；9011 凸脊部；902 腿部；9021 勾部；
S1 第一密封圈；S2 第二密封圈；
R 径向；A 轴向；D 下方。
具体实施方式
下面参照附图描述本发明的示例性实施方式。应当理解，这些具体的说明仅用于示教本领域技术人员如何实施本发明，而不用于穷举本发明的所有可行的方式，也不用于限制本发明的范围。
以下除非特别说明，参照图2，在附图和说明中，A表示唾液采检装置的轴向，R表示唾液采检装置的径向。箭头D所指的方向为下方，与之相反为上方。
在本实施方式中，唾液采检装置包括储液手柄100、采样手柄200、检测容器300、试纸卡塞400、储液体500、采样体600、指示件700、密封膜800、卡扣900、第一密封圈S1和第二密封圈S2。
储液手柄100、储液体500、指示件700和第一密封圈S1装配在一起共同 参与构成储液组件。
采样手柄200、采样体600、第二密封圈S2和上述的储液组件装配在一起共同参与构成采样组件。
优选地，储液体500和采样体600均由吸水性强的纤维构成、并被压缩成圆柱状。
(储液组件)
首先参照图1、图2和图6，介绍储液组件的基本结构。
储液手柄100在储液组件中起到了支架的作用，其用于固定储液体500。储液手柄100包括在轴向A上依次相连的卡盘101、连接筒102和固定筒103。
卡盘101呈环状，其中间通孔连通到连接筒102的内腔，用于使下文将介绍的卡扣900在拆装时通过。卡盘101的外周部具有两个径向对称的缺口1011，其用于在将储液手柄100安装到采样手柄200时对卡盘101起到轴向限位的作用，下文将进一步介绍。
连接筒102的外径小于卡盘101的外径。连接筒102的周壁具有两个径向对称的卡口1021，用于固定下文将介绍的卡扣900。
固定筒103呈一端开口的大致盖状，其内腔用于固定储液体500。优选地，固定筒103的外周壁具有向径向内侧凹进的环状的凹部，第一密封圈S1安装于该凹部。
储液体500在轴向A上的一端连接了指示件700。指示件700的制作材料包括吸水性材料，例如指示件700为变色试纸，其吸水前后的颜色不同。当储液体500吸收了足量的唾液样本后，唾液会进一步传递到指示件700并被其吸收，指示件700变色。优选地，指示件700环绕地包覆在储液体500的轴向一端。
优选地，附着有指示件700的储液体500的一端通过点胶粘接的方式固定到储液体固定环103。
(采样组件)
接下来参照图1至图4，介绍采样组件的基本结构。
采样手柄200在采样组件中起到了支架的作用，其用于固定采样体600、第二密封圈S2和储液组件。
采样手柄200呈中空的筒状，其在轴向A上依次包括内腔均连通的第一筒201、第二筒202、第三筒203、锁闭筒204和手持筒205。
第一筒201呈大致盖状，其内腔用于容纳采样体600。采样体600在自然状态下是伸出于第一筒201的，即在采样组件未装配入检测容器300时，采样体600的轴向长度大于第一筒201的轴向长度，被试者能够将采样体600的伸出端置于口中以采集唾液。
第二筒202的内腔用于容纳储液体500。第二筒202的内径小于第一筒201的内径，这使得采样体600在轴向A上能够被第一筒201的端部固定而限位，这在下文介绍采样体600受轴向挤压而变形时将更容易被理解。
第三筒203用于容纳固定筒103并与其紧密地配合以形成端部密封的结构，例如第三筒203的内径略小于第一密封圈S1的外径，从而使第一密封圈S1能密封地填充固定筒103和第三筒203之间的径向间隙。第三筒203的内径大于第二筒202的内径。
锁闭筒204的外周壁具有锁闭结构，该锁闭结构用于与下文将介绍的检测容器300的内周壁的锁闭结构耦合，从而实现采样手柄200和检测容器300的可拆卸的连接。优选地，锁闭筒204的外周壁的锁闭结构和检测容器300的内周壁的锁闭结构均为螺纹结构。
优选地，在锁闭筒204的根部，即锁闭筒204的靠近第三筒203的端面，具有朝向下方凸出的在径向上对称的定位部2041。定位部2041用于抵靠到下文将介绍的试纸卡塞400的轴向端部，实现采样手柄200和试纸卡塞400在检测容器300内的紧密配合。
手持筒205的周壁的内径大于锁闭筒204的周壁的内径。从而在手持筒205和锁闭筒204之间形成连接二者的环状的止挡壁2052。一方面，第二密封圈S2可以套设在锁闭筒204的外周并抵靠到止挡壁2052从而在轴向A上获得限位。另一方面，当储液手柄100安装到采样手柄200时，止挡壁2052在轴向 A上对储液手柄100的卡盘101起到限位作用，下文在介绍储液手柄100和采样手柄200的装配关系时将进一步说明。另外，当采样手柄200安装到检测容器300后，锁闭筒204将被收容在检测容器300的内腔、而手持筒205露出检测容器300以方便对采样手柄200的拆装。
采样组件在装配时，储液组件从采样手柄200的上部伸入采样手柄200，使缺口1011在周向上对准挡条2051，卡盘101进入手持筒205的内腔、并使卡盘101抵靠到止挡壁2052。优选地，从挡条2051的位于下方D的端面到止挡壁2052的位于上方的端面之间的距离等于卡盘101在轴向A上的厚度。之后周向地转动卡盘，使缺口1011和挡条2051在周向上错开，于是缺口1011和挡条2051在轴向A的两侧将卡盘101限位。
在对采样手柄200和储液手柄100的安装过程(或下文将提到的拆卸过程)中，可以借助卡扣900来操作储液手柄100。参照图4，卡扣900包括柱状的基部901和连接于基部901的沿轴向延伸的在径向上对称的两个腿部902。腿部902的远离基部901的端部具有向径向外侧凸出的勾部9021。优选地，两个腿部902的位于外周的端面(不包括勾部9021)与基部901的外周面共面，而基部901的外径(不包括凸脊部9011)等于连接筒102的内径，两个勾部9021的外周面之间的径向距离大于连接筒102的内径。优选地，基部901的外周壁具有多个周向分布的、沿轴向延伸的凸脊，从而形成凸脊部9011，凸脊部9011的表面不平整、摩擦系数大，使得抓持凸脊部9011以操作卡扣900周向转动时更容易。
将卡扣900以腿部902朝内的方式伸入连接筒102的内腔，此时两个勾部9021受连接筒102的内壁的挤压而互相靠拢，使两个腿部902向径向内侧发生弹性变形。周向对准地使勾部9021进入卡口1021，此时腿部902向径向外侧恢复原形或至少减少变形量，勾部9021至少部分地收容在卡口1021内使卡扣900在连接筒102内得到定位。拆卸卡扣900时，从卡口1021处对勾部9021向径向内侧施力，使勾部9021进入连接筒102的内壁的径向内侧，抓持凸脊部9011将卡扣900轴向地取出连接筒102。
储液组件与采样手柄200完成装配后，储液体500接触到采样体600，以保证采样体600吸收的唾液能传递至储液体500处得到储存。
储液组件装配到采样手柄200后，密封膜800被密封地连接到手持筒205的轴向端部。密封膜800例如是容易撕开的锡箔纸。当需要使用储液体500内储存的唾液样本时，操作者可以将密封膜800撕开，借助卡扣900把储液组件从采样手柄200内取出。
应当理解，卡扣900可以不配置在唾液采检装置的套件中，例如卡扣900只用于提供给装置出厂前的装配人员和复检时的操作者，卡扣900可以是重复利用的。于是其他人员在不借助其它工具的情况下，很难将储液组件从采样手柄200中取出，这有助于控制检测过程的质量。
(唾液采检装置)
包括储液组件的采样组件与检测容器300和试纸卡塞400共同构成了根据本发明的唾液采检装置。
参照图1至图4，检测容器300呈一端开口的筒状。检测容器300的内底面的中间部分向开口处凸起形成凸台301(参照图2)，从而在凸台301的外周限定出环形槽302。
试纸卡塞400呈两端开口的筒状，其能够紧贴检测容器300内壁地置于检测容器300内。试纸卡塞400的外周壁限定出多个用于存放检测试纸的试纸槽401(参照图3)。试纸卡塞400的轴向一端轴向凸出地设有若干支撑部402，换言之，试纸卡塞400的一个端部在轴向上是不平齐的。把试纸卡塞400以支撑部402朝内的方式置于检测容器300内，支撑部402将抵靠到环形槽302的轴向上的槽底，而环形槽302在周向上具有不被试纸卡塞400填满的区域，这些区域为唾液样本提供了流动空间。
试纸卡塞400的内径等于或略大于第三筒203的外径和第一筒201的外径。
参照图2，储液组件装配到检测容器后，采样手柄200的第三筒203、第二筒202和第一筒201收容于试纸卡塞400的内周侧，采样体600接触凸台301 并与凸台301互相挤压，使采样体600在轴向上被压缩，采样体600内吸收的唾液样本受挤压而流出，唾液样本流经环形槽302后接触到试纸卡塞400内存放的检测试纸从而得到检测。
优选地，检测容器300的侧壁为透明的，使得操作者能方便地透过检测容器300观察检测试纸的变化。
在采样体600被压缩的过程中，由于第一筒201的轴向端部的壁对采样体600的轴向限位作用，储液体500几乎不会受到影响而变形，储液体500内存储的唾液样本不会流出。于是在采样体600内储存的唾液样本完成一次检测后，储液体500内的储存的唾液样本还可以供下一次检测用。
复检时，通过撕去密封膜800，借助卡扣900将储液组件取出，之后例如将储液组件放入复检容器内通过挤压的方式将储液体500内储存的唾液样本挤出以进行复检。
本发明至少具有以下优点中的一个优点：
(i)本发明的采样组件将一次采集到的唾液样本分别储存在可分离开的采样体600和储液体500内，且通过合理的结构设计，取用采样体600内唾液样本的操作过程不会影响储液体500内的唾液样本。
(ii)通过指示件700的颜色变化，简单且明显地指示出采样量是否符合要求，提高采样过程的效率。
(iii)密封膜800撕开后即破损，且将储液手柄100从采样手柄200内取出需要借助例如卡扣900等工具，上述设置能阻止储液组件在不期望的情况下被取出，例如，在检测被试者是否吸食毒品时，当样本的首次检测结果为阳性而需要对储液体500内的唾液样本做复检时，不希望无关人员将储液体500提前取出甚至调换而干扰复检结果。
当然，本发明不限于上述实施方式，本领域技术人员在本发明的教导下可以对本发明的上述实施方式做出各种变型，而不脱离本发明的范围。例如：
(i)缺口1011的数量和挡条2051的数量不限于两个，只需要缺口1011 和挡条2051能在周向上配合即可；且当缺口1011和挡条2051的数量为多个时，它们也不必须在周向上均匀分布或径向对称。
(ii)卡口1021的数量和腿部902的数量不限于两个，只需要卡口1021和腿部902能在周向上配合即可；且当卡口1021和腿部902的数量为多个时，它们也不必须在周向上均匀分布。
(iii)本发明对指示件700的具体尺寸和形状不作限制，指示件700也不必须紧贴储液体500的端部设置，只需要满足指示件700的设置位置能指示足量的唾液样本、且操作者能透过采样手柄200观察到指示件700的颜色变化即可。优选地，采样手柄200是透明的，或者至少在固定指示件700的轴向位置处，采样手柄200是透明的。

Claims (10)

  1. 一种唾液采检装置，其包括检测容器(300)、采样手柄(200)和采样体(600)，其特征在于，所述装置还包括储液组件，
    所述储液组件包括储液体(500)，
    所述储液体(500)和所述采样体(600)用于吸收唾液样本，
    所述采样手柄(200)呈筒形，所述采样体(600)固定于所述采样手柄(200)的一个端部并至少部分地伸出所述采样手柄(200)，
    所述储液组件能够伸入所述采样手柄(200)的内腔并与所述采样手柄(200)能拆卸地固定安装连接，当所述储液组件与所述采样手柄(200)固定安装后，所述储液体(500)和所述采样体(600)接触，
    所述采样手柄(200)能够伸入所述检测容器(300)的内腔，并使所述采样体(600)挤压所述检测容器(300)以释放所述唾液样本。
  2. 根据权利要求1所述的唾液采检装置，其特征在于，所述采样手柄(200)包括在轴向上依次相连的第一筒(201)和第二筒(202)，所述第一筒(201)的内径大于所述第二筒(202)的内径，
    所述采样体(600)固定并部分地收容于所述第一筒(201)的内腔，所述储液体(500)至少部分地收容于所述第二筒(202)的内腔。
  3. 根据权利要求2所述的唾液采检装置，其特征在于，所述采样手柄(200)还包括第三筒(203)，所述第三筒(203)在轴向上与所述第二筒(202)相连，所述第三筒(203)的内径大于所述第二筒(202)的内径，所述储液组件能够与所述第三筒(203)的内壁密封地装配。
  4. 根据权利要求1所述的唾液采检装置，其特征在于，所述采样手柄(200)还包括锁闭筒(204)，所述锁闭筒(204)的外周壁具有与所述检测容器(300)能拆卸地连接的锁闭结构。
  5. 根据权利要求4所述的唾液采检装置，其特征在于，所述采样手柄(200)还包括在轴向上与所述锁闭筒(204)连接且位于所述采样手柄(200) 的另一个端部的手持筒(205)，所述手持筒(205)的外径大于所述锁闭筒(204)的外径，从而在所述手持筒(205)和所述锁闭筒(204)之间形成环形的止挡壁(2052)。
  6. 根据权利要求5所述的唾液采检装置，其特征在于，所述储液组件还包括储液手柄(100)，所述储液体(500)固定于所述储液手柄(100)，
    所述储液手柄(100)包括卡盘(101)，所述卡盘(101)的外径大于所述锁闭筒(204)的内径而小于所述手持筒(205)的内径，
    所述卡盘(101)的外周部具有缺口(1011)，所述手持筒(205)的内壁具有与所述缺口(1011)配合的挡条(2051)，
    当所述卡盘(101)安装到所述手持筒(205)的内腔后，所述挡条(2051)和所述止挡壁(2052)在所述卡盘(101)的轴向两侧对所述卡盘(101)限位。
  7. 根据权利要求6所述的唾液采检装置，其特征在于，所述储液组件还包括与所述卡盘(101)相连的连接筒(102)，所述卡盘(101)具有与所述连接筒(102)的内腔相通的开口，
    所述连接筒(102)的内壁具有卡口(1021)，使得所述连接筒(102)能与拆装工具配合而受控地与所述采样手柄(200)安装和/或拆卸。
  8. 根据权利要求7所述的唾液采检装置，其特征在于，所述唾液采检装置还包括卡扣(900)，所述卡扣(900)用作所述拆装工具以辅助所述储液组件与所述采样手柄(200)的安装和/或拆卸，
    所述卡扣(900)包括柱状的基部(901)和连接于所述基部(901)且沿轴向延伸的腿部(902)，所述腿部(902)具有勾部(9021)，
    当所述卡扣(900)部分地伸入所述连接筒(102)内时，所述腿部(902)受到所述连接筒(102)的壁的挤压，所述勾部(9021)伸入所述卡口(1021)，使得所述卡扣(900)能拆卸地与所述储液手柄(100)固定连接。
  9. 根据权利要求1所述的唾液采检装置，其特征在于，所述装置还包括密封膜(800)，所述密封膜(800)密封地固定在所述采样手柄(200)的远离所述采样体(600)的另一个端部。
  10. 根据权利要求1所述的唾液采检装置，其特征在于，所述储液组件还包括润湿后能够变色的指示件(700)，所述指示件(700)安装于所述储液体(500)的远离所述采样体(600)的端部。
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