CN110161265B - A device for collecting liquid samples - Google Patents

A device for collecting liquid samples Download PDF

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Publication number
CN110161265B
CN110161265B CN201810714500.XA CN201810714500A CN110161265B CN 110161265 B CN110161265 B CN 110161265B CN 201810714500 A CN201810714500 A CN 201810714500A CN 110161265 B CN110161265 B CN 110161265B
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China
Prior art keywords
chamber
liquid
cavity
channel
sealing element
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CN110161265A (en
Inventor
吴志强
洪亮
朱杨煜
科恩·罗玲
吴淑江
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Hangzhou Biotest Biotech Co Ltd
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Hangzhou Biotest Biotech Co Ltd
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Application filed by Hangzhou Biotest Biotech Co Ltd filed Critical Hangzhou Biotest Biotech Co Ltd
Priority to US16/044,283 priority Critical patent/US10830672B2/en
Priority to MX2020008505A priority patent/MX2020008505A/en
Priority to PCT/CN2018/096954 priority patent/WO2019157796A1/en
Priority to EP18906159.1A priority patent/EP3752841B1/en
Priority to US16/967,957 priority patent/US12360019B2/en
Publication of CN110161265A publication Critical patent/CN110161265A/en
Application granted granted Critical
Publication of CN110161265B publication Critical patent/CN110161265B/en
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00Sampling; Preparing specimens for investigation
    • G01N1/02Devices for withdrawing samples
    • G01N1/10Devices for withdrawing samples in the liquid or fluent state
    • G01N1/18Devices for withdrawing samples in the liquid or fluent state with provision for splitting samples into portions
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G01N35/1095Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices for supplying the samples to flow-through analysers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/06Fluid handling related problems
    • B01L2200/0684Venting, avoiding backpressure, avoid gas bubbles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/06Fluid handling related problems
    • B01L2200/0689Sealing
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/14Process control and prevention of errors
    • B01L2200/141Preventing contamination, tampering
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/04Closures and closing means
    • B01L2300/041Connecting closures to device or container
    • B01L2300/042Caps; Plugs
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/08Geometry, shape and general structure
    • B01L2300/0861Configuration of multiple channels and/or chambers in a single devices
    • B01L2300/087Multiple sequential chambers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00Moving or stopping fluids
    • B01L2400/04Moving fluids with specific forces or mechanical means
    • B01L2400/0403Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0457Moving fluids with specific forces or mechanical means specific forces passive flow or gravitation

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biochemistry (AREA)
  • Pathology (AREA)
  • Immunology (AREA)
  • General Physics & Mathematics (AREA)
  • Physics & Mathematics (AREA)
  • Hematology (AREA)
  • Hydrology & Water Resources (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Clinical Laboratory Science (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

本发明提供一种收集和检测液体样本的装置,该装置包括第一腔和第二腔,第一腔用来收集液体样本并进行初始检测,第二腔用来收集液体样本以备二次确认检测之用。该装置的第一腔和第二腔为可拆卸式结合。当需要进行二次确认检测时,第二腔可与第一腔分离,然后送往确认检测机构进行确认检测。可避免传统装置的检测试剂条与液体样本接触时可能对样本产生的污染;有效地减少了储存液体样本所需的空间,大大降低了运输过程液体样本泄漏的风险。

The present invention provides a device for collecting and testing liquid samples, the device comprising a first cavity and a second cavity, the first cavity is used to collect liquid samples and perform initial testing, and the second cavity is used to collect liquid samples for secondary confirmation testing. The first cavity and the second cavity of the device are detachably combined. When a secondary confirmation test is required, the second cavity can be separated from the first cavity and then sent to a confirmation testing agency for confirmation testing. This can avoid the contamination of the sample that may be caused by the detection reagent strip of the traditional device when it contacts the liquid sample; effectively reduce the space required for storing the liquid sample, and greatly reduce the risk of liquid sample leakage during transportation.

Description

Device for collecting liquid sample
The present application claims priority from chinese prior application, application number 201810150485.0, filing date 2018-02-13.
Technical Field
The present invention relates to a device for collecting a liquid sample, and more particularly to a device for collecting and detecting an analyte in a liquid sample, such as a urine collection and detection device, in the field of rapid diagnosis.
Background
Currently, detection devices for detecting whether a sample contains an analyte are used in hospitals or homes in large numbers, and these detection devices for rapid diagnosis contain one or more detection reagent strips, such as early pregnancy detection, etc. The rapid diagnostic test device is very convenient and can obtain test results on the test reagent strips in one minute or at most ten minutes.
Although in the conventional technique, the sample to be detected can be isolated from the collected sample, it is costly and not easy to handle. For example, U.S. patent No. 7,300,633 describes a piston urine cup that, when the piston is advanced, allows a liquid sample, such as urine, in a collection chamber to be transferred from the collection chamber to a detection chamber where a test element for detecting an analyte in the sample is located, and the liquid sample in the collection chamber is isolated by the piston so that the samples in the two locations are not confused and can be used for later confirmatory detection. Although this isolates the sample being tested from the sample collected, the urine cup of such a piston is costly and difficult to operate, and requires relatively great effort to push the piston after all, since the piston must be brought into fluid tight engagement with the wall of the piston, which necessitates a tight engagement between the piston and the piston chamber, and the entire device must be moved to the testing mechanism for a second test.
For another example, U.S. patent 8,992,855 describes a device for collecting a liquid sample that includes a plunger structure integral with and moving with the cap, and that, while allowing separation of the sample from the collected sample, requires significant pressure to be overcome to gain access after the sample has entered the detection chamber, and also requires precise sizing of the cap and cup opening so that the plunger integral with the cap can be accurately inserted into the separation chamber.
In addition, after the preliminary tests of the conventional collecting and detecting devices and the like are completed, if the subsequent confirmation detection is required, the whole collecting and detecting device needs to be transported to a confirmation detecting mechanism for further confirmation detection, which brings about a plurality of problems, at least such that, firstly, most of the liquid collecting and detecting devices are only provided with a preliminary detecting cavity at present. If a subsequent confirmatory test is required, the entire device containing urine and test reagent strips can only be sent to a confirmatory test mechanism for testing. Thus, the sample in the urine cup may be contaminated with the detection reagent. Secondly, when the whole device is sent to the confirmation detection mechanism, more cost is needed to enable the device to have better sealing effect due to the larger cup opening and the risk of leakage in the transportation process, so that the risk of leakage is reduced as much as possible, thirdly, the confirmation detection mechanism needs a huge low-temperature warehouse to store the whole detection device to prevent the deterioration of a liquid sample, and preparation is made for possible further confirmation detection, so that the cost of the confirmation detection mechanism (which can be called as a secondary detection mechanism) is greatly increased.
In view of the above-mentioned problems, improvements are needed to solve the shortcomings of the conventional techniques.
Disclosure of Invention
In view of the foregoing, it is an object of the present invention to provide a testing device capable of separating an initial test sample and a confirmation test sample (secondary test), which can allow the initial test sample and the confirmation test sample to enter two chambers, such as a first chamber and a second chamber, after collecting a liquid sample before or after testing, and then separate the second chamber from an initial collection chamber (first chamber) after or before the initial test is completed, thereby realizing the detachable separation of the second chamber and the chamber for initially collecting the sample. A second chamber separate from the initial collection chamber may be used for a subsequent second test or subsequent confirmation test. Thus, the effective separation of the initial detection sample and the subsequent possible confirmation detection sample (second detection) is achieved, and finally, the initial detection sample and the subsequent possible confirmation detection sample are collected once, and at least two detections are witnessed.
It is also contemplated that when the collection device includes two chambers that receive the same liquid sample, such as urine, either simultaneously or sequentially, one chamber, such as a first chamber, is used to collect a portion of the liquid sample and the other chamber, such as a second chamber, is used to collect another portion of the liquid sample. After collection or while collection, the liquid in the first chamber may be used to contact the test element to complete a first test and the second chamber may be separated from the first chamber for a second test.
In a first aspect, the invention provides a device for collecting a liquid sample, the device comprising a first chamber for collecting a liquid sample and a second chamber for collecting a sample for confirming detection of the liquid sample, wherein the first chamber and the second chamber are removably coupled, combined or connected.
In some preferred forms, the first and second chambers are in fluid communication prior to the second chamber being separated from the first chamber, or the first and second chambers are in fluid communication when the first and second chambers are combined. Thus, whether the first or second chamber collects or receives a liquid sample, the liquid can be allowed to flow within both chambers, such that the flow is either active or passive.
In some preferred forms, the active flow is such that liquid may naturally flow from the first chamber to the second chamber or from the second chamber to the first chamber without external forces. In some preferred forms, the passive flow is by an external force to flow liquid from the first chamber to the second chamber or from the second chamber to the first chamber. External force herein may refer to negative pressure, forcing the liquid, thereby allowing the liquid to flow.
In some preferred forms, the first chamber and the second chamber are not in fluid communication after or just prior to separation of the second chamber from the first chamber, such that fluid does not flow between the two chambers. In some preferred forms, the first and second chambers are not in liquid communication prior to or just prior to separation of the second chamber from the first chamber. Or in some preferred forms, the first chamber and the second chamber are not in liquid communication while the second chamber is separated from the first chamber. In some preferred forms, the second chamber is separated from the first chamber and the second chamber stores a liquid sample from the first chamber. In some preferred forms, the second chamber also collects the liquid sample from the first chamber at the time the first chamber collects the liquid sample or after the collection is completed. In some preferred forms, the second chamber collects liquid sample from within the first chamber at the same time as the first chamber collects liquid sample.
In some further embodiments, the first and second chambers are removably coupled together by a coupling location, and separated by the coupling location. The two cavities are separated before use, and are assembled together during use, and are separated after use. Or the first and second chambers may be directly combined together or may be indirectly combined together by a certain structure. The combined location may be where the first and second chambers physically contact. Thus, in another aspect of the invention, the first chamber and the second chamber are initially assembled together and the second chamber is separated from the first chamber after the liquid sample is collected. The first chamber may be used for a first test and the second chamber may be used for a second test or for a confirmation test. Alternatively, the first and second chambers are initially separate and not assembled, and after the liquid sample is collected, the second chamber is combined with the first chamber so that a portion of the liquid is communicated or flowed between the first and second chambers, and the two chambers are separated when a secondary test is required. The first chamber may be used for a first test and the second chamber may be used for a second test or for a confirmation test.
In a second aspect, the invention provides a device for collecting a liquid sample, the device comprising a first chamber for collecting a liquid sample and a second chamber for collecting a sample for confirming detection of the liquid sample, wherein the first chamber and the second chamber are indirectly or directly detachably coupled, combined or connected together by a combining location.
In some preferred forms, the second chamber and the first chamber are in fluid communication via a connecting channel. In some preferred forms, the first chamber and the second chamber are in fluid communication through the connecting channel before the second chamber is not separated from the first chamber. In some preferred forms, after or while the second chamber is separated from the first chamber, the first chamber and the second chamber are not in fluid communication, while the passageway is sealed. In some preferred forms, the second chamber is separated from the first chamber and the second chamber stores a liquid sample from the first chamber. In some preferred forms, the second chamber also collects liquid sample from the first chamber through the connecting channel at the time of or after the first chamber collects liquid sample. In some preferred forms, the second chamber also collects liquid sample from the first chamber through the connecting channel at the same time as the first chamber collects liquid sample.
In one of the foregoing embodiments, the first chamber includes an opening for collecting a liquid sample, the liquid sample passing through the opening into the first chamber. In some preferred forms, the connecting channel is in fluid communication with the first and second chambers, and the liquid sample can be in fluid communication between the first and second chambers through the connecting channel. In some preferred forms, the liquid sample is able to flow from the first chamber into the second chamber through the connecting channel. In some preferred forms, the connecting channel has a first opening in fluid communication with the first chamber and a second opening in fluid communication with the second chamber. In some preferred forms, the connecting channel is located on or within the first chamber. The second chamber is detachably connected, combined or combined with the first chamber through a connection channel. The connecting channel may thus allow the first and second chambers to be in an indirect removable combination, bonded or otherwise connected together.
In some preferred forms, the connecting channel includes a structure connecting the first chamber and the second chamber and a structure separating the first chamber and the second chamber, wherein the structure connecting the first and second chambers is a space or a pipe constituting the channel. In other preferred forms, either the connecting channel has a sealed or unsealed condition, in which liquid can flow from the first chamber to the second chamber. Preferably, when the connecting channel is in a sealed state, liquid in the first chamber cannot flow from the connecting channel into the second chamber. Therefore, the sealing or unsealing of the connecting channel defines a state of liquid exchange between the first chamber and the second chamber, and if the connecting channel is unsealed, liquid exchange is possible between the two chambers, and when the connecting channel is sealed, no liquid exchange is possible between the two chambers.
In a third aspect of the invention, a sealing element is provided that seals a connecting channel such that the connecting channel is in a sealed state. In a preferred manner, the connecting channel connects the first chamber and the second chamber such that the second chamber is in a liquid-tight state with respect to the first chamber by sealing with the sealing element. In some preferred forms, the device further comprises a sealing element sealing the connection channel. In some preferred forms, the sealing element excludes the liquid sample from the second chamber portion at the time of sealing the channel or simultaneously with sealing or after sealing. Preferably, the liquid sample is removed into the first chamber. Or the sealing element seals the connecting channel while part of the liquid sample (if any) in the connecting channel is removed to a place outside the connecting channel, e.g. in the first chamber or elsewhere. In some preferred embodiments, the sealing element may further comprise an elastic sealing ring, which allows the sealing element to contact the inner wall of the connecting channel, thereby allowing the sealing element to seal more. In other preferred forms, the sealing member is more flexible relative to the connecting channel such that upon contact between the two, either is deformed or compressed to bring the sealing member into intimate contact with the inner wall of the connecting channel, thereby providing a sealing effect. For example, the sealing element is resilient and the connecting channel is rigid, such that when an external force forces the sealing element into the connecting channel, the resilient element is compressed to deform, thereby sealing the connecting channel.
In other embodiments, the sealing element and the connection are sealed by means of threads. For example, the sealing element has an external thread and the connecting channel has an internal thread, the sealing element sealing the connecting channel by means of a relative rotation. In other preferred embodiments, the sealing element is a cap-like structure having internal threads and the first open outer edge of the connecting channel has external threads so that the sealing element and the connecting channel can act as a seal.
In a fourth aspect of the invention, the device of the invention may further comprise a drainage element, a portion of which enters the second chamber before the sealing element seals the first opening of the connection channel. In some preferred forms, after the sealing element seals the opening of the connecting channel, a portion of the drainage element enters the second chamber. Or a portion of the drainage member passes through the connecting channel into the second chamber before the sealing member seals the first opening of the connecting channel.
Thus, in a fourth aspect of the invention, the device of the invention provides a drainage element for draining part of the liquid in the second chamber out of the second chamber. Preferably, a portion of the drainage member enters the second chamber before the sealing member seals the first opening of the connecting channel. In some preferred forms, after the sealing element seals the opening of the connecting channel, a portion of the drainage element enters the second chamber. Optionally, the drain member is connected to the second chamber via a connecting channel so as to drain a portion of the liquid out of the second chamber. In some preferred forms, the drainage element and the sealing element are connected as a unitary structure. In some embodiments, the drainage element enters the liquid connection channel before the sealing element. Preferably, the second chamber is detachably coupled, combined or connected with the first chamber through the second opening of the liquid connection channel. Or alternatively, the drain member is adjacent to the first opening of the connecting channel prior to the sealing member, wherein the first opening is in fluid communication with the first chamber. In some preferred forms, the sealing element is integrally or removably combined with the drainage element, or in some forms, the sealing element may serve two functions, sealing and drainage being performed simultaneously, alternatively the drainage element may serve two functions, sealing the linking channel simultaneously. The difference in names here is merely a difference in functions, and of course, two functions may be implemented by one element.
In a fifth aspect of the invention, the device of the invention may further comprise a lyophobic channel through which liquid removed by the drain element or the sealing element is removed outside the connection channel and/or the second chamber. What is meant by outside includes in the first cavity or elsewhere, for example in the receiving cavity. In some preferred forms, a liquid receiving cavity is included in the sealing member, and the liquid sample removed from the second cavity enters the receiving cavity of the sealing member through the lyophobic passageway. The term "receiving chamber" as used herein refers to a chamber that collects excess liquid that is removed by the drain or seal, and thus, the receiving chamber may be the first chamber or elsewhere, such as a space within the seal or drain. In this way, the discharged liquid enters the accommodating cavity through the lyophobic channel. In some preferred forms, the lyophobic channel has one or more liquid inlets through which liquid is allowed to enter the receiving chamber. In some preferred forms, the liquid inlet is located downstream of the first opening of the connecting channel. Or the lyophobic channel is provided with one or more liquid inlets which are positioned on the sealing element, wherein the liquid inlets enter the connecting channel before the sealing element. In some preferred embodiments, the lyophobic channel inlet opening is located in the second cavity after the sealing member seals the connecting channel. In some preferred forms, the receiving cavity is located within the sealing element. In some preferred forms, the liquid inlet of the lyophobic channel is located on the wall of the sealing element. In some preferred forms, the liquid inlet of the lyophobic channel is located at the end of the sealing element.
In some preferred embodiments, the sealing element is integrally formed with the drainage element, wherein the drainage element enters the connecting channel prior to the sealing element. In some preferred forms, a portion of the drainage member enters the second chamber and the sealing member seals the connection channel, preferably the sealing member is located in the connection channel. In some aspects, the liquid inlet of the lyophobic channel is located between the sealing member and the liquid discharge member, or is located below the sealing member, or is located on the liquid discharge member. In some embodiments, the liquid inlet of the lyophobic channel is disposed at the end of the liquid discharge element, either before the liquid discharge element enters the connecting channel or before the liquid discharge element enters the second chamber.
In a sixth aspect of the present invention, there is provided an open first cover for covering a first chamber for collecting a liquid sample, wherein a sealing member for sealing a connecting passage is connected to the cover, or the sealing member is integrated with the cover. Thus, when the first cover body covers the opening of the first cavity, the sealing element also enters the connecting channel to seal the connecting channel. In some preferred forms, the first cover includes a sealing element. In some preferred forms, a sealing member coupled to the first cover seals the first opening of the connection channel while the first cover covers the first cavity opening. The process of closing the opening of the first cavity with the first cover is performed almost substantially simultaneously with the sealing of the first opening of the connecting channel with the sealing element. Or when the sealing element and the liquid discharging element are connected into a whole, or the sealing element and the liquid discharging element are arranged on the first cover body, the three parts can be connected into a whole or can be combined in a detachable way. Thus, the cover body covers the opening of the first cavity, and the process from cover to cover is completed, namely the sealing element seals the opening of the connecting channel, and the liquid draining element drains part of liquid (if any) in the second cavity, and the redundant drained liquid enters the accommodating cavity through the liquid draining channel.
In some preferred embodiments, the central axis of the sealing element on the cover and the central axis of the connecting channel are substantially on the same line, so that the sealing element can also seal the connecting channel when the first cover is closed over the first cavity opening. In some preferred forms, the sealing element is removably connected to the cover. In some embodiments, the sealing element is threadably coupled to the cover. In some embodiments, the sealing element is connected to the cover by a connecting rod such that the first cavity has a depth, the sealing element being located at or near the opening of the connecting channel when the cover is closed over the opening of the first cavity, and the sealing element connected to the connecting rod being introduced into the connecting channel from the first opening near the connecting channel when the cover is closed over the first cavity, thereby sealing the connecting channel.
It will be appreciated that the sealing element is connected to one end of the connecting rod, while the other end of the connecting rod is connected to the cover, and movement of the cover drives the sealing element to move synchronously, for example, rotation of the cover drives rotation of the sealing element, or movement of the cover from top to bottom drives movement of the sealing element from top to bottom. It will be further appreciated that the synchronous movement is capable of sealing the connecting channel when the sealing element seals the connecting channel by means of a piston. Of course, if the sealing element and the connecting channel are threaded, a synchronous rotation also allows the sealing element to seal the connecting channel.
In some aspects, the present invention provides an open first cover for covering a first chamber for collecting a liquid sample, wherein the first cover comprises a sealing element and a liquid draining element, or the sealing element and the liquid draining element are connected with the cover, or are integrally connected with the cover. In some preferred forms, the sealing member coupled to the first cover seals the first opening of the connecting channel while the first cover covers the first cavity opening, and the drain member enters the second cavity. It will be appreciated that movement of the first cover moves the sealing member and the drain member together.
In a seventh aspect of the invention, in some preferred forms, the device of the invention may further comprise a second cover for sealing the opening of the second chamber. In some embodiments, the second cover is disposed over the second cover, and when it is desired to seal the opening of the second cavity, the second cover is removed from the first cover to seal the opening of the second cavity. Thus, in some embodiments, the second cover is positioned over the first cover by means of threads, pistons, latches, etc. In other preferred forms, the second cover is removably positioned over the first cover such that the second cover can be easily removed from the first cover.
In some preferred versions of all of the foregoing, the second chamber has an opening for collecting a liquid sample. In some preferred forms, the opening of the second chamber is in fluid communication with the second opening of the connecting channel. In some preferred forms, the second chamber is removably connected to the connection channel by threads. In some preferred embodiments, the opening of the second chamber has an internal thread and an external thread, wherein the internal thread is matingly coupled with the external thread of the connecting channel. The external thread of the second cavity opening is connected with a second cover body which covers the second cavity opening in a matched mode. Alternatively, the second cavity and the second opening of the connecting channel may be detachably connected together in a clamping manner without using a screw thread manner.
In some preferred forms, the device further comprises a test element, the test element being in fluid communication with the first chamber. In some preferred forms, the device further comprises a detection chamber, and the test element is located in the detection chamber.
In an eighth aspect of the invention there is provided a method of collecting a liquid sample, the method comprising providing a device for collecting a liquid sample as described above, the device comprising a first chamber for collecting a liquid sample and a second chamber for collecting a liquid sample for confirmatory testing, wherein the first chamber and the second chamber are removably coupled, combined or connected, and allowing the liquid sample to enter the first chamber through an opening in the first chamber and allowing the liquid sample to enter the second chamber from the first chamber.
In some preferred forms, the device includes a connecting channel that places the first and second chambers in fluid communication.
In some preferred forms, the method provides a sealing element, and the connecting channel is sealed with the sealing element after the liquid has entered the second chamber.
In some preferred forms, the second chamber is separated from the first chamber after the sealing member seals the connection channel.
In some preferred forms, the opening of the second chamber is covered with a cover after the second chamber is separated from the first chamber.
In some preferred forms, the method includes, after separating the second chamber from the first chamber, leaving the first chamber and the second chamber out of fluid communication. In some preferred forms, the second chamber is configured to store a liquid sample from the first chamber after the second chamber is separated from the first chamber. In some preferred forms, the second chamber is also allowed to collect the liquid sample from the first chamber at the time or after the first chamber is allowed to collect the liquid sample. In some preferred forms, the second chamber collects liquid sample from within the first chamber at the same time as the first chamber collects liquid sample.
In some preferred forms, the method includes placing the first and second chambers in fluid communication through a connecting channel. In some preferred forms, the first chamber and the second chamber are placed in fluid communication through the passageway before the second chamber is allowed to remain unseated from the first chamber. In some preferred forms, after or while the second chamber is separated from the first chamber, the first chamber and the second chamber are not in fluid communication, and the connecting channel is sealed. In some preferred embodiments, after separating the second chamber from the first chamber, the second chamber is allowed to store the liquid sample from the first chamber. In some preferred forms, the second chamber also collects liquid sample from the first chamber through the connecting channel at the time of or after the first chamber collects liquid sample. In some preferred forms, the second chamber is also collected with the liquid sample from the first chamber through the connecting channel at the same time as the liquid sample is collected in the first chamber.
In some preferred forms, the first chamber includes an opening for collecting a liquid sample, and the liquid sample is allowed to pass through the opening into the first chamber. In some preferred forms, the connecting channel communicates between the first and second chambers such that the liquid sample can be exchanged between the first and second chambers through the connecting channel. In some preferred forms, the liquid sample is capable of flowing from the first chamber into the second chamber through the liquid channel. In some preferred forms, the connecting channel has a first opening and a second opening, wherein the first opening is in fluid communication with the first chamber and the second opening is in fluid communication with the second chamber. In some preferred forms, the connecting channel is located on or within the first chamber. The second chamber is removably connected, joined or combined with the first chamber by a fluid passageway.
In some preferred forms, the connecting channel has a structure that communicates the first chamber and the second chamber and a structure that separates the first chamber and the second chamber, wherein the structure that communicates the first and second chambers is the space that constitutes the channel. Or the connecting channel has two states of sealing or unsealing, when the connecting channel is in the unsealed state, the liquid can flow from the first cavity to the second cavity, and when the connecting channel is in the sealed state, the liquid in the first cavity can not flow from the connecting channel to the second cavity.
In some preferred forms, the method includes the apparatus including an open first cover for covering the first chamber for collecting the liquid sample, wherein the sealing member is coupled to the cover. In some preferred forms, the first cover includes a sealing element. In some preferred forms, the sealing element to which the first cover is attached seals the second cavity opening of the connection channel at the same time as, or during or after, the first cover covers the first cavity opening. In some preferred forms, the cover includes a second cover for sealing the opening of the second cavity. In some preferred forms, the sealing element is removably connected to the cover. In some embodiments, the sealing element is threadably coupled to the cover.
In some preferred forms, the second chamber has an opening for collecting a liquid sample. In some preferred forms, the opening of the second chamber is in fluid communication with the second chamber opening of the connecting channel. In some preferred forms, the second chamber is removably connected to the connection channel by threads. In some preferred embodiments, the opening of the second chamber has an internal thread and an external thread, wherein the internal thread is matingly coupled with the external thread of the connecting channel. The external thread of the second cavity opening is connected with a second cover body which covers the second cavity opening in a matched mode.
The detachable connection mode of the first cavity and the second cavity is that the detachable connection is carried out through the structural design of the connecting channel and the second cavity, and the detachable connection is a direct connection. In some preferred forms, the second chamber may be removably connected, combined or joined together with the first chamber in a threaded connection, the first and second chambers being in fluid communication when directly removably joined together between the second chamber and the chamber. Preferably, the first and second chambers are in fluid communication via a connecting channel. In some preferred forms, the opening of the second chamber is in fluid communication with the second opening of the connecting channel. In some preferred forms, the second chamber is provided on a base that is removably combined with the first chamber. Optionally, the second cavity is also detachably combined with the base. Thus, when the base is directly combined with the first chamber, the open connecting channels of the second chamber are in fluid communication. When the base is separated from the first cavity, the second cavity located on the base is separated from the second cavity along with the base. Preferably, when the base is separated from the first chamber, the second chamber located on the base is separated from the connection passage along with the base. In some preferred forms, the second cavity is separated from the base after the base and the second cavity on the base are separated from the first cavity. In some preferred forms, the opening of the second cavity is covered with a second cover after the second cavity is separated from the base.
In a sixth aspect of the invention, there is provided a method of collecting a liquid sample, the method comprising providing a device for collecting a liquid sample as hereinbefore described, the device comprising a first chamber and a second chamber, wherein the second chamber and the first chamber are detachably connected, the liquid sample being collected by the first chamber and allowed to flow into the second chamber.
In some preferred forms, the second chamber is separated from the first chamber when the second chamber collects a liquid sample, such that the opening of the second chamber is covered with a second cover.
In some preferred forms, the first and second chambers are connected together by a connecting channel, wherein the first opening of the connecting channel is in fluid communication with the first chamber and the second opening of the connecting channel is in fluid communication with the second chamber.
In some preferred forms, the device further comprises a sealing element that seals the connection channel before the second chamber is separated from the first chamber.
In some preferred forms, the device further comprises a cover, the cover and the sealing element being integrally formed such that when the cover is closed over the first opening, the cover simultaneously moves the sealing element to seal the second opening of the connecting channel.
In some preferred embodiments, the cover is arranged to carry the sealing element into the connecting channel. In some preferred forms, the second chamber is separated from the first chamber after the sealing member seals the connection passage.
In some preferred modes, a liquid draining element for draining part of the liquid in the second cavity is further arranged on the cover body, so that the cover body drives the liquid draining element to enter the second cavity. In some preferred forms, the cover is provided with a sealing element and a drainage element, the drainage element being advanced into the second chamber before the sealing element.
In some preferred embodiments, the device further comprises a lyophobic channel, and the liquid sample discharged from the liquid discharging element is discharged out of the second cavity through the lyophobic channel. In some preferred embodiments, the sealing element is allowed to enter the connection channel, and the liquid discharged from the sealing element is discharged to the outside of the connection channel through the lyophobic channel.
In some preferred forms, the liquid removed by the sealing element or the drainage element is drained through the lyophobic channel into the first chamber. In some preferred forms, a receiving chamber is provided in the cover, said receiving chamber being in fluid communication with the lyophobic channel, wherein fluid removed by the sealing element or the draining element is drained into the receiving chamber through the lyophobic channel.
In a ninth aspect, the present invention provides a method for detecting the presence of an analyte in a liquid sample, the method comprising the step of using a test element to detect the presence of the analyte in the liquid sample after the liquid sample has been collected in the first chamber by the liquid collection device according to any of the above aspects. And after the detection result is obtained, separating the second cavity from the first cavity, and performing separation according to any mode.
In some embodiments, the device further comprises a detection chamber for receiving the test element, the detection chamber being in flow communication with the first chamber, the liquid flowing into the detection chamber after the first chamber has collected the liquid sample. When the test element is included in the test chamber, the second chamber is separated from the first chamber after the test element completes the test. In some preferred forms, the liquid sample is allowed to pass from within the first chamber into the detection chamber and then into the second chamber. Such a configuration is designed as described above to avoid that liquid entering the detection chamber also enters the second chamber, thereby contaminating the liquid sample in the second chamber.
In a tenth aspect of the present invention, the present invention provides a cap body provided with a sealing member for sealing a connection passage. In some preferred embodiments, a sealing ring is provided on the sealing element. In some preferred embodiments, the material of the sealing element and the connecting channel are the same or different. In some preferred forms, the sealing member is a flexible material and the connecting channel is a rigid material. In some preferred forms, the sealing element is integrally formed with the first cover by a connecting rod. In some preferred forms, the sealing element further comprises an opening for a lyophobic channel. In some preferred embodiments, the opening of the lyophobic channel is located below the sealing element, or the opening of the lyophobic channel enters the connecting channel before the sealing element. In some preferred forms, the cover further includes a receiving cavity thereon in fluid communication with the lyophobic channel. The accommodating cavity is communicated with the opening of the lyophobic channel. In some preferred forms, the receiving cavity is located in the sealing element.
In other preferred embodiments, a drainage element is also provided on the first cover, which drainage element is further away from the first cover than the sealing element. The drain element is either arranged below the sealing element or the sealing element and the drain element are arranged such that the drain element enters the second chamber before the sealing element or the drain element enters the connecting channel before the sealing element. Or when the cover body is provided with a connecting rod to connect the first cover body and the sealing element, and the sealing element is connected with the liquid draining element. Or the connecting rod, the sealing element and the liquid draining element are integrated.
Advantageous effects
By adopting the structure, the device has the characteristics of simple and reasonable structure, low cost of used materials, excellent performance and convenience for secondary detection. In particular, when the subsequent confirmation detection is required, the whole detection device is not required to be sent to the testing mechanism for detection, but only the second cavity is taken down from the device and then is sent to the detection structure, so that the safety is realized, the space is saved, the cost is saved, and the environment is protected.
Drawings
Fig. 1 is a schematic exploded structural view of a collecting device in one embodiment of the present invention.
Fig. 2 is a schematic perspective view of a cover according to an embodiment of the present invention.
Fig. 3 is a schematic view showing a longitudinal sectional structure of the cover body shown in fig. 2 in an embodiment of the present invention.
Fig. 4 is a longitudinal cross-sectional view of the first chamber in an embodiment of the invention, showing the schematic structure (without the detection chamber).
Fig. 5 is a longitudinal section view showing the structure of the second chamber in one embodiment of the present invention.
Fig. 6 is a schematic perspective view of an embodiment of the present invention without the first cover.
Fig. 7 is a schematic view of the device of fig. 6 in a longitudinal section showing the structural intent, wherein the first chamber and the first chamber are combined.
Fig. 8 is a partially enlarged schematic view of a combination of a first chamber and a second chamber in one embodiment of the invention.
Fig. 9 is a schematic perspective view showing a combination of a first chamber and a second chamber in one embodiment of the present invention.
Fig. 10 is a structural perspective view illustrating an operation of covering the opening of the first cavity with the first cover according to an embodiment of the present invention.
Fig. 11 is a schematic perspective view of a first cover body after covering an opening of a first cavity according to an embodiment of the present invention.
Fig. 12 is a schematic cross-sectional view of the device of fig. 11 in accordance with an embodiment of the present invention.
Fig. 13 is a schematic perspective view showing that the second cavity is separated from the first cavity and the second cover is separated from the first cover in an embodiment of the present invention.
Fig. 14 is a schematic perspective view of a second cover covering a second cavity according to an embodiment of the present invention.
Fig. 15 is a schematic perspective view of a device according to another embodiment of the present invention.
Fig. 16 is a schematic perspective view of a first chamber according to an embodiment of the present invention.
Fig. 17 is a schematic perspective view of a test element carrier in accordance with one embodiment of the present invention.
Fig. 18 is a schematic perspective view of a first cover with a sealing element according to an embodiment of the present invention.
Fig. 19 is a schematic perspective view of a first chamber (without a second chamber) in one embodiment of the invention.
Fig. 20 is a schematic cross-sectional view of a combination of the second chamber (an enlarged schematic view of a portion of the first chamber and the second chamber in a detachable combination) according to an embodiment of the present invention.
Fig. 21 is a schematic perspective view of a first cover body according to another embodiment of the present invention after the first cover body begins to cover the opening of the first cavity (operation process).
Fig. 22 is a schematic cross-sectional view of the device of fig. 21 (the sealing element does not seal the connecting channel, and begins to approach the opening) in an embodiment of the invention.
Fig. 23 is a schematic cross-sectional view of the device (sealing member into the connecting channel) according to an embodiment of the present invention.
Fig. 24 is a schematic perspective view showing that the second cavity is separated from the first cavity and the second cover is separated from the first cover in an embodiment of the present invention.
Fig. 25 is a schematic perspective view of a combination process of a second chamber and a first chamber in a detection or collection device (the second chamber is located in a tray structure) according to another embodiment of the present invention.
Fig. 26 is a schematic view showing a structure of the first chamber combined with the tray in the detecting or collecting device according to the present invention.
Fig. 27 is a schematic sectional view showing the structure shown in fig. 26 in the detecting or collecting device of the present invention.
Fig. 28 is a schematic view showing a structure of sealing the second cavity by the second cover in another embodiment of the present invention.
Fig. 29 is a schematic view of the structure of the second chamber exiting the tray.
Fig. 30 is a schematic perspective view of a tray having each second cavity coupled to the first cavity.
Fig. 31 is a schematic perspective view of a first cover with a sealing element according to another embodiment of the present invention.
Fig. 32 is a schematic cross-sectional view of a first cover with a sealing element according to another embodiment of the present invention shown in fig. 31.
Fig. 33 is a schematic perspective view of a sealing member according to another embodiment of the present invention.
Fig. 34 is a schematic cross-sectional view of the structure shown in fig. 33.
Fig. 35 is a schematic view showing the structure of a seal member, a drain member, or one of the seal members shown in fig. 33 exchanged or default, wherein fig. 35A is a sectional view and fig. 35B is a perspective view.
Fig. 36 is a schematic structural view showing separation and combination of the first chamber and the second chamber in other embodiments of the present invention.
Fig. 37 is a schematic view showing the structure of a combination of the first chamber and the second chamber in another embodiment of the present invention.
Fig. 38A and 38B are schematic diagrams showing the structure of the first chamber as a secondary confirmation detection, in which the first chamber and the second chamber are separated from each other as shown in fig. 37.
Fig. 39 is a schematic diagram of the principle of the three-dimensional structure of the first chamber and the second chamber in other embodiments of the present invention.
Fig. 40 is a schematic structural diagram showing the principle of the three-dimensional structure of the first chamber and the second chamber separated and combined in other embodiments of the present invention.
Detailed Description
The structures and terms of art to which the present invention pertains are further described below, as understood and interpreted in accordance with the general terms of art unless otherwise specified.
Detection of
Detection indicates the assay or testing for the presence of a substance or material, such as, but not limited to, a chemical substance, an organic compound, an inorganic compound, a metabolic product, a drug or drug metabolite, an organic tissue or a metabolite of an organic tissue, a nucleic acid, a protein or a polymer. In addition, the detection indicates the amount of the test substance or material. Further, assays also refer to immunoassays, chemical assays, enzymatic assays, and the like.
Sample of
The detection device or collected sample of the present invention includes biological fluids (e.g., case fluids or clinical samples). The liquid sample or liquid samples may be derived from solid or semi-solid samples, including fecal matter, biological tissue, and food samples. The solid or semi-solid sample may be converted to a liquid sample using any suitable method, such as mixing, mashing, macerating, incubating, dissolving, or digesting the solid sample with enzymatic digestion in a suitable solution (e.g., water, phosphate solution, or other buffer solution). "biological samples" include animal, plant and food samples, including, for example, urine, saliva, blood and components thereof, spinal fluid, vaginal secretions, sperm, feces, sweat, secretions, tissues, organs, tumors, cultures of tissues and organs, cell cultures and media derived from humans or animals. Preferably the biological sample is urine. Food samples include food processed materials, end products, meats, cheeses, wines, milks and drinking water. Plant samples include plants, plant tissues, plant cell cultures and media derived from any plant. An "environmental sample" is derived from the environment (e.g., a liquid sample from a lake or other body of water, a sewage sample, an earth sample, groundwater, seawater, and a waste liquid sample). The environmental sample may also include sewage or other wastewater.
Any analyte may be detected using a suitable detection element of the present invention. Saliva and urine are preferably detected by the present invention. Of course, any of the above forms of sample may be collected using the collection device of the present invention, whether initially solid or liquid, and such liquid sample may flow into the second chamber simultaneously or later, as long as such liquid or liquid sample flows into the first chamber, and as the second chamber may be removably coupled, combined or otherwise connected to the first chamber, the second chamber may be separated from the first chamber when subsequent confirmatory testing is desired, such that the second chamber may be subjected to a secondary test and the liquid of the first chamber may be subjected to a primary test. Alternatively, the liquid in the second chamber may be subjected to a primary test, while the liquid in the first chamber may be subjected to a secondary test.
Alternatively, after the liquid sample or processed sample is collected in liquid form in the first chamber, the second chamber may be used to extract a portion of the liquid sample in the first chamber for later use in a confirmatory assay, either before or after the initial assay. The first chamber may be combined with the second chamber at the beginning or at the time of use and then separated.
Downstream and upstream
Downstream or upstream is divided with respect to the direction of liquid flow, typically liquid flowing from upstream to downstream regions. The downstream region receives liquid from the upstream region and liquid may also flow along the upstream region to the downstream region. Here, the flow direction of the liquid is generally divided, for example, on some materials that use capillary force to promote the flow of the liquid, the liquid may flow in a direction opposite to the gravity, and at this time, the upstream and downstream are also divided according to the flow direction of the liquid. For example, in some preferred embodiments of the collection device of the present invention, the first chamber acts as a chamber for collecting a liquid sample, while the second chamber is in fluid communication with the first chamber, the liquid entering the first chamber flowing into the second chamber, the first chamber may be referred to as upstream and the second chamber may be referred to as downstream. Of course, this flow is a natural flow under the force of gravity of the liquid. Optionally, the natural flow is a flow of liquid from the first chamber into the second chamber. Of course, the liquid may also flow passively from upstream to downstream, for example, in the case of a liquid being forced to flow from upstream to downstream by a reaction force, or from a low position to a high position, this reaction may be capillary action, or the forcing of ambient pressure, thereby allowing the liquid to flow from low to high, where the division of upstream and downstream does not necessarily mean that there is necessarily a need for the liquid to be present, meaning that the flow is in the order of flow in the presence of the liquid.
Gas or liquid communication
Gas or liquid communication refers to the ability of a liquid or gas to flow from one location to another, where the flow may be directed through some physical structure. By physical structures is generally meant that liquid flows passively or actively to another place through the surfaces of the physical structures, or through the spaces within the structures, the passive being generally flow caused by external forces, such as capillary action. The flow may be liquid or gas, or may be passive, due to its own action (gravity or pressure). Communication herein does not necessarily require the presence of a liquid or gas, but merely in some cases indicates a connection or state between two objects, and if a liquid is present, may flow from one object to another. Here, it refers to a state where two objects are connected, but conversely, if there is no liquid communication or gas communication between the two objects, if there is liquid in or on one object, the liquid cannot flow into or on the other object, and such a state is a non-communication, non-liquid or gas communication state.
Detachable combination
By detachably combined, it is meant that the connection between two components is in several different states or positional relationships, e.g. when two components are physically separated, they may initially be separated, when connected or combined together in a suitable first instance, and when two components may be separated in a suitable second instance, such separation being spatially separated in a physical sense without touching. Or the two components may be initially brought together, where appropriate, to form a physical spatial separation. Either the two objects are initially separated, combined together as needed to perform a function, and then separated again, or later recombined again for a purpose. In general, the combination of the two or the separation between the two can be easily performed, and the combination or the separation can be repeated for a plurality of times, and of course, the combination and the separation can also be disposable. In addition, two components can be combined in a detachable way, and three or more components can be combined in a detachable way. For example, having first, second and third components, the first and second components may be removably combined, the second and third components may be removably combined, and the first and third components may be removably combined or separated. In addition, the combination mode can be that two objects are detachable, or can be indirectly combined through another object.
Test element
The term "test element" as used herein refers to an element that can detect whether a sample or specimen contains an analyte of interest, and can be referred to as a test element, regardless of the principle of technology, immunological, chemical, electrical, optical, molecular, nucleic acid, physical, etc. The test element may be a lateral flow test strip that detects multiple analytes. Of course, other suitable test elements may be used with the present invention,
Various test elements may be combined together for use in the present invention. One form is test paper. Test strips for analyzing analytes in a sample, such as metabolites indicative of a physical condition, may be in various forms, such as immunoassay or chemical analysis. The test strip can adopt an analysis mode of a non-competition method or a competition method. The test paper comprises a water absorbing material with a sample adding area, a reagent area and a test area. Sample is applied to the sample application region and flows to the reagent region by capillary action. In the reagent zone, the sample binds to the reagent if the analyte is present. The sample then continues to flow to the detection zone. Other reagents, such as molecules that specifically bind to the analyte, are immobilized in the detection zone. These reagents react with and bind the analyte (if present) in the sample to the region, or to a reagent in the reagent region. The label for displaying the detection signal is present in a separate label zone from the reagent zone.
A typical non-competitive assay format is one in which a signal is generated if the sample contains an analyte and no signal is generated if the sample does not contain an analyte. In competition methods, a signal is generated if the analyte is not present in the sample, and no signal is generated if the analyte is present.
The test element can be a test paper, and can be made of a material which absorbs or does not absorb water. The test strip may comprise a variety of materials for liquid sample transfer. One of the test strips may be coated with another material, such as a filter paper, on a nitrocellulose membrane. One region of the test strip may be of one or more materials and another region of the test strip of a different material or materials. The test strip may be adhered to a support or hard surface for improving the strength of the pinch test strip.
The analyte is detected by the signal generating system, e.g., using one or more enzymes that specifically react with the analyte, and the composition of the one or more signal generating systems is immobilized on the analyte detection zone of the test strip using the method of immobilizing a specific binding material on the test strip as described previously. The signal generating substance may be on the sample application zone, reagent zone, or test zone, or the entire test strip, and the substance may be impregnated with one or more materials of the test strip. The solution containing the signal is applied to the surface of the test strip or one or more materials of the test strip are immersed in the solution containing the signal. The test paper added with the signal-containing substance solution is dried.
The various zones of the test strip may be arranged in such a way that the sample application zone, reagent zone, test zone, control zone, determine if the sample is adulterated, and liquid sample absorption zone. The control zone is located behind the detection zone. All zones may be arranged on a strip of paper of only one material. Different materials may be used for the different regions. Each zone may be in direct contact with the liquid sample or the different zones may be arranged in accordance with the direction of flow of the liquid sample, with the ends of each zone being connected to and overlapping the front end of the other zone. The material used may be a material with good water absorption such as filter paper, glass fiber or nitrocellulose membrane. The test strip may take other forms.
The reagent strip is usually a nitrocellulose membrane reagent strip, namely the detection area comprises a nitrocellulose membrane, and specific binding molecules are immobilized on the nitrocellulose membrane to display the detection result, and can also be a cellulose acetate membrane or a nylon membrane and the like. Such as the reagent strips or devices :US 4857453;US 5073484;US5119831;US 5185127;US 5275785;US 5416000;US 5504013;US 5602040;US 5622871;US5654162;US 5656503;US 5686315;US 5766961;US 5770460;US 5916815;US 5976895;US6248598;US 6140136;US 6187269;US 6187598;US 6228660;US 6235241;US 6306642;US6352862;US 6372515;US 6379620; containing the reagent strips and US 6403383 described in some of the following patents. The test strips disclosed in the above patent documents and similar devices with test strips can be used in the test element or test device of the present invention for the detection of an analyte, for example in a sample.
The test strips used in the present invention may be so-called lateral flow test strips (Lateralflowtest strip), the specific construction and detection principles of which are well known to those of ordinary skill in the art. A typical test strip comprises a sample collection area, a label area, a detection area and a bibulous area, wherein the sample collection area comprises a sample receiving pad, the label area comprises a label pad, and the bibulous area may comprise a bibulous pad, wherein the detection area comprises a necessary chemical, such as an immunological or enzymatic chemical, capable of detecting the presence of an analyte. The general detection reagent strip is a nitrocellulose membrane reagent strip, namely, a detection area comprises a nitrocellulose membrane, a specific binding molecule is immobilized on the nitrocellulose membrane to display the detection result, and the detection reagent strip can also be a cellulose acetate membrane or a nylon membrane, and the like, and a detection result control area can also be arranged at the downstream of the detection area, wherein the control area and the detection area are usually arranged in a transverse line form and are detection lines or control lines. Such test strips are conventional, although other types of strips that utilize capillary action for testing are possible. In addition, the test strip typically carries a dry reagent component, such as an immobilized antibody or other reagent, which, upon encountering the liquid, flows along the strip with capillary action, and with the flow, dissolves the dry reagent component in the liquid, thereby allowing the dry reagent in the zone to react to the next zone for the necessary test. The liquid flow is mainly by capillary action. These test elements are described and recorded in Li Fugang, ma Gongyan, etc., analysis of the performance of chromatographic membrane materials in colloidal gold diagnostic kit, wang Yong, wang Luhai, etc., a novel colloidal gold immunochromatographic test strip. May be used in the detection device of the present invention, or may be disposed in the detection chamber in contact with the liquid sample, or may be used to detect the presence or amount of analyte in the liquid sample entering the detection chamber.
Except that the test strip described above or the lateral flow test strip itself is used to contact the fluid in the first chamber to test whether the fluid sample contains an analyte. In some preferred forms, the test elements may also be provided on carriers such as cards 106 having a plurality of recesses in which the test elements are located, the entire test card being disposed in the test cavity 105 with the sample application area of the test elements at the bottom 1051 of the test cavity to contact the liquid sample. Such liquid sample may come from the first chamber 103, for example, the liquid sample is in liquid communication through the through-hole 1038 between the detection chamber 105 and the first chamber (e.g., as shown in fig. 9 and 1). It is also possible to locate the sample application area of the test element in the sample collection area of the test chamber to contact the liquid sample, thereby completing the test of the analyte.
In another manner, such as shown in fig. 16 and 17, a carrier 206 is provided having a plurality of channels with one end sealed 2062 and the other end open 2063, one or more test strips disposed in the channels, a sample application area of the test strips disposed at one end of the opening 2063, one or more channels for receiving the test strips disposed in the carrier 206, one test element disposed in each channel, and when there are a plurality of channels, a different test element for an analyte disposed in each channel, such that a plurality of analytes can be detected using the same sample. Such a carrier 206 is placed in the first cavity 203 with two stop bars 2032 and 2033 on the walls of the cavity 203, and the carrier 206 is inserted or snapped into the two stop slots with the open channel end 2065 near the bottom of the first cavity and the sealed channel end 2064 near the first cavity opening 2031 (FIG. 16). When the liquid sample flows into the first chamber through the opening 2031 of the first chamber, the liquid sample contacts the sample application area of the test strip, thereby completing the test. Such vectors are described in detail in U.S. patent application Ser. No. 15/644,148, and Chinese patent application Ser. No. 2016106132817,2016106079834, filed by the present inventors. Of course, other carriers than those disclosed in the above patents may be used in the present application as carriers for carrying the test strips.
For example, in some embodiments, the first chamber may collect a liquid sample and then use the test element alone to detect the analyte in the liquid sample in the first chamber. The test is performed with a test strip or a card or carrier with a test strip inserted into the first cavity. Those of ordinary skill in the art will appreciate that the test strips may not be disposed on a carrier, but rather may be independent, as described herein, and that the detection chamber 105 of the present invention may be absent in some cases, and the test strips may be absent in some cases. As will be described in detail later.
Analyte substance
Examples of analytes that can be used in the present invention include small molecular substances that are present in or part of body fluids such as blood, urine, saliva, sweat, etc.
For example, analytes to be detected with the present invention include, but are not limited to, creatinine, bilirubin, nitrite, proteins (non-specific), hormones (e.g., human chorionic gonadotropin, progestin, follicular stimulating hormone, etc.), blood, leukocytes, sugars, heavy metals or toxins, bacterial substances (e.g., proteins or carbohydrate substances directed against specific bacteria, such as e.g., E.coli 0157: H7, staphylococci, salmonella, clostridium, campylobacter, L. Unicytogenes, vibrio, or Cactus) and substances associated with physiological characteristics in urine samples, such as pH and specific gravity. Any other clinical urine chemistry analysis can be tested using lateral flow testing in combination with the device of the present invention.
Flow of liquid
The flow of liquid generally refers to the flow from one place to another, and in general, the flow of liquid in nature mostly flows from high place to low place by gravity, and the flow here also depends on external force, namely, the flow under the external gravity condition, and can be the flow of natural gravity. In addition to gravity, the flow of liquid may also take over gravity, moving from low to high. For example, the liquid is pumped, or the liquid is pressed, or the liquid is pressurized, and flows from the bottom to the top, or the liquid flows due to the gravity of the customer due to pressure concerns. For example, in fig. 9, 19, 22 and 27, the first chamber is located above the second chamber, and the second chamber is located below the first chamber, so that when liquid enters the second chamber, the liquid can naturally flow from the first chamber to the second chamber by gravity or from the upstream to the downstream position by gravity.
Detecting or collecting devices
The detection device is a device for detecting whether or not the sample contains an analyte. The collection device refers to collection and storage of the liquid sample. The detection means may comprise collecting means, which may also comprise detecting means, or which may be separate from the detecting means, and the collecting means and the detecting means may be combined at the time of detection, thereby completing the detection. The device may be a device in which the collection device and the detection device are integrally formed, and once the liquid sample is collected, the detection can be performed immediately to obtain a test result, and the separation of the detection sample and the collection sample can be performed simultaneously, so that the secondary detection (if necessary) can be performed. The meaning of the detection device or the detection chamber may be interchanged, or the collection device and the collection chamber may be interchanged, and functions may be interchanged only by different functions. For example, the invention is said to be a collection device that does not include a detection chamber or that does not include a test element, but the collection device may include a test element or a carrier containing a test element, which may also be referred to as a detection device. Of course, the collection means may comprise space for the test elements, but need not necessarily comprise test elements, which may be combined with the collection means at any suitable later time to become the detection means. For example, the collection device may include a space for receiving a test element, such as a test chamber 105 (FIG. 7), or a suitable location for placement of the test element or carrier containing the test element in a liquid collection chamber of the collection device (FIG. 16), so the invention may be a device designed for collection of a liquid sample alone or a test device that performs simultaneous testing at the time of collection.
The first and second chambers being detachably combined, joined or mated
The first and second chambers of the present invention may form a removable pair of combinations, the first and second chambers being combined when liquid collection is required and the second chamber being separable from the first chamber after collection of the liquid sample is completed. Or the first cavity and the second cavity are separated, when the liquid sample needs to be collected, the first cavity and the second cavity are combined together, and after the collection is completed, the first cavity and the second cavity are separated. In some embodiments of the present invention, as shown in one embodiment in fig. 1-14, the present invention provides a detection device for detecting whether a liquid sample contains an analyte or a collection device for collecting a liquid sample, which comprises a first chamber 103 and a second chamber 104, wherein the first chamber 103 can be used as a collection chamber, i.e. for collecting a liquid sample, and wherein the first chamber and the second chamber are detachably combined, connected or assembled.
The terms "combine, connect, or assemble" as used herein mean substantially the same, but the terms are used to indicate a combination, which corresponds to "separate. The combination and separation can be carried out under any conditions and can be freely selected. In some aspects, the first chamber and the second chamber are in fluid communication when the first chamber and the second chamber are combined. In other embodiments, the first and second chambers are not in fluid communication either before or while the first and second chambers are separated, or after separation.
In some preferred forms, the device further comprises a connecting channel with which the first lumen is removably engaged, joined or assembled. Thus, a detachable combination, coupling or assembly with the second cavity is achieved. As shown in fig. 9, the first chamber 103 is used as a collection chamber having an opening 1031 for collecting or receiving a liquid sample, and the liquid sample flows into the first chamber 103 through the opening, and has a connection channel 109 at the bottom of the first chamber, the connection channel having a first opening 1091, and the other end having a second opening 1092. The first opening 1091 of the connection channel 109 is in fluid communication with the first chamber 103, and the fluid sample of the first chamber can flow through the opening 1091 into the connection channel 109 and then out through the second opening 1092 at the other end. The present invention therefore provides a chamber for collecting a fluid sample, the chamber comprising an opening 1031 for allowing the fluid sample to enter the chamber 103, and a channel at the bottom of the collection chamber, the channel having a first opening and a second opening, a portion of the fluid sample being able to enter the connecting channel through the first opening 1091 of the connecting channel and exit through the second opening 1090 of the connecting channel. Outflow refers to outflow outside the first chamber 103. Preferably, the liquid flowing out of the connection channel enters the second chamber 104. The collection device may therefore also comprise a second chamber, typically the first chamber having an opening and side walls and a bottom to define a cavity. The connecting channel is typically located on the bottom of the first chamber. In this particular embodiment, the connecting channel is located on the region of the bottom. But is not limited to the location of the connecting channel and may be located on the side wall or at the junction of the bottom and the side wall. Any position is possible as long as the liquid sample entering the collection chamber 103 can enter the connecting channel.
By "connecting channel" is meant herein generally a structure that connects the first and second chambers, allowing the first and second chambers to be connected or joined together when desired, and allowing the second and first chambers to be separated in some cases. In fact, here, the connecting channel serves two functions at the same time, one is to connect the first and second chambers together in a detachable manner, and the other structure serves at the same time to communicate the fluid of the first and second chambers, through which the fluid can flow between the two chambers to each other, such as a tube, a groove, or other means, so that the use of a "connecting channel" is a preferred embodiment of the invention. It will be appreciated that in a preferred embodiment, the connection and the passage for bringing the first and second chambers into fluid communication form two different functions for the same structure, for example the tube-shaped structure of the invention, the connection passage shown in fig. 9 or fig. 9 and fig. 4 having both the structure for connecting the second chamber to the first chamber and also having a fluid communication. It will be appreciated that the mechanism of the connecting channel may be defective, as will be described in more detail below in further embodiments. Of course, the term "connecting channel" is understood to mean a connection that allows the second chamber and the first chamber to be detachably connected or combined without having the function of allowing the second chamber and the first chamber to be in fluid communication, and alternatively, the term "connecting channel" is understood to mean a connection that allows the second chamber and the first chamber to be in fluid communication without having the function of connecting the first chamber and the second chamber. Alternatively, the term "connection channel" is understood to mean the connection described above, i.e. having the common energy of the connection, and also having the function of allowing fluid communication.
In some preferred forms, there is an external thread on the outside of the second opening of the connecting channel. The second cavity 104 is provided, the second cavity 104 has an opening 1042, the second opening 1042 and the connecting channel have an outer diameter which is equal to or slightly larger than the outer diameter of the connecting channel, and an inner thread is provided inside the opening of the second cavity 104, so that the second cavity and the first cavity can be detachably engaged, combined or connected by the engagement of the outer thread of the connecting channel and the outer thread of the second cavity. That is, the second chamber is directly screwed to the connection channel when the assembly is performed, and the second chamber 104 is separated from the connection channel by the reverse screw to be separated from the collection chamber 103 when the disassembly is required. Or an internal thread is provided in the second opening 1092 of the connection channel and an external thread is provided outside the opening 1042 of the second chamber 104, the internal thread of the channel opening mating with the external thread of the second chamber, thereby allowing the first and second chambers to be assembled or connected in a removable manner. When the second chamber is separated from the first chamber, the opening 1042 of the second chamber is covered with a second cover, thereby sealing the second chamber.
Of course, alternatively, as shown in fig. 9, the outer wall of the second opening 1092 of the connection channel is not threaded, but an elongated space 1098 is provided on the outer wall of the second opening 1092 of the connection channel 109, and the elongated space just fits with the opening of the second cavity 104, i.e. fits with the thickness of the opening of the second cavity. For example, the elongated space is formed by the outer wall 1095 of the second opening 1092 of the connecting channel and the corresponding wall 110 (as shown in fig. 8), and a threaded structure is provided on the wall 110 that mates with the external threads at the opening 1042 of the second chamber 104, so that the external threads of the second chamber mate with the threads on the wall 110, thereby effecting a combination of the first chamber and the second chamber, which combination is also accomplished by the mating of the inner wall of the second chamber opening with the outer wall of the end 1092 of the connecting channel. The second cavity 104 and the first cavity 103 are in a detachable fit, combination or connection. In order to provide a better sealing engagement between the first chamber and the second chamber, a second sealing ring 107 may be provided inside the opening of the second chamber, which allows the inner wall of the opening of the second chamber to more closely engage the outer wall of the connecting channel, thereby preventing leakage of the liquid sample into the second chamber 104 (as shown in fig. 8 and 9). Those of ordinary skill in the art will appreciate that by "detachable" herein is meant that two objects can be combined together to form a unitary structure when desired, and that they can be easily separated when it is desired to separate the two objects, such separation being primarily in a physical sense of spatial structural non-contact.
In addition to the threaded connection, the detachable connection may be any other connection method, such as a snap-fit connection method, a piston connection method, a locking connection method, etc., so long as the first cavity and the second cavity can be combined and connected together when needed, so that a part of the liquid sample is obtained from the first cavity, and when the first cavity and the second cavity are separated, the first cavity and the second cavity are separated. For example, in the form of threads that rotate in opposite directions to separate from the first chamber, or in other ways, for example by extraction, unlocking, to allow the second chamber 104 to be conveniently separated from the second chamber after a liquid sample has been obtained from the first chamber. This way of obtaining a liquid is sufficient to keep the first 103 and second 104 chambers in liquid communication when connected.
Of course, in a specific embodiment, it is also preferred that the connection channel 109 and the first cavity 103 are injection molded once, while the second cavity 104 is another injection molded, the second cavity being detachably coupled, engaged or combined with the connection channel. It will be appreciated that the connecting channel 109 is injection molded once with the second cavity 104, and that it is also possible that the connecting channel 109 is detachably coupled, joined or combined with the first cavity 103 together with the second cavity 104.
Thus, the function of so-called "connecting" itself may be performed by a single structure, with the fluid communication between the first and second chambers being performed by another structure. It will also be readily appreciated that the first and second chambers may be detachably connected together, for example by a connection mechanism by which the liquid cannot flow between the second chamber and the first chamber itself, but by another structure, for example a channel, to allow liquid to flow from the first chamber to the second chamber. It will be appreciated, therefore, that in some preferred forms the device further comprises a connection structure by which the first and second chambers are detachably engaged, joined or assembled, the first and second chambers being placed in fluid communication when connected by the connection structure. Here the fluid communication may be by another structure, such as a tube, a channel, a groove, to put the two chambers in fluid communication.
Those skilled in the art will appreciate that the connection channel 109 may be omitted herein. The first chamber may be configured to collect a liquid sample, for example, in a second chamber connected to the first chamber, and the second chamber may be configured to be easily separated from the first chamber when separation of the second chamber from the first chamber is desired, which may be other suitable means as would be apparent to one of ordinary skill in the art. For example, as shown in fig. 36, a hole 903 is provided in the side wall of the first cavity 903, the hole is sealed by a film that is easy to puncture or is sealed by self-sealing silica gel, rubber or soft plastic, when a sample needs to be collected, the first cavity 903 is used for collecting the sample, after the sample of the liquid is collected, a second cavity 904 (which is not connected with the first cavity at the beginning) is provided, and the sealing film (not shown) on the first cavity is punctured at the opening part of the second cavity, so that the liquid in the first cavity flows into the second cavity, and then is separated from the first cavity again, so that the liquid in the second cavity is used for secondary detection. As another example, as illustrated in fig. 37-38, the first and second chambers are not detachably combined by the connecting passage, but are detachably combined by the mutually engaged screw structures. As further illustrated in fig. 25-27, the removable combination is provided by a tray structure, as will be described in more detail below.
Alternatively, referring to fig. 8, the present invention designs the connection channel 109 to connect with the opening 1042 of the second cavity 104, and of course, the connection channel 109 may not be needed, but the opening 1042 of the second cavity 104 is used as a connection channel, and the opening 1042 of the second cavity is directly connected with the interior of the first cavity, and the connection can be in the form of a clamping connection, a piston connection, or a locking connection, so long as the opening 1042 of the second cavity corresponds to the hole, and the liquid can flow to the second cavity through the first cavity. Preferably, the first chamber and the second chamber are connected together before the first chamber collects the sample, and separation is convenient when the second chamber needs to be separated from the first chamber.
In other preferred forms, the first and second chambers are removably connected, combined or joined, not directly removably connected as shown in fig. 33 without additional structure, nor indirectly through a connecting channel as shown in fig. 8-9, 1, 22-23, but removably connected or combined as shown in fig. 25-30. As described in detail below.
Accordingly, in another aspect of the present invention, there is provided a collection or testing device comprising a first chamber for collecting a liquid sample and a second chamber for performing a confirmatory secondary test, wherein the device further comprises a tray structure which is removably combined, joined or assembled with the first chamber. In some embodiments, the second cavity is located on the tray, that is, the detachable combination or combination between the second cavity and the first cavity is indirectly achieved by the detachable combination or combination of the tray and the first cavity, that is, the tray structure and the second cavity are performed by means of linkage, where the linkage is generally that the movement of the tray drives the movement of the second cavity, so as to achieve separation from the first cavity, and then after the linkage, separation from the tray structure or no separation can be achieved.
In this case, the connection passage may or may not be provided, and therefore, the communication structure is not necessary. For example, as shown in fig. 25-30, the second cavity is located on a base structure or tray structure 1004, the opening of which is still in fluid communication with the connecting channel (having a connecting channel), but need not rely on its own structure to directly connect to achieve fluid communication as previously described, whereas in this embodiment, only the opening of the second cavity is required to engage with the second outlet of the connecting channel, while the base structure 1004 is engaged with the bottom of the first cavity 103 by a mating structure such as in the form of a screw thread (fig. 27). Thus, the base structure has threads, such as external threads, and the bottom of the first cavity has internal threads, which are threadably combined together to provide a tight fit between the second cavity and the connecting channel by the coupling force of the threads. Specifically, as shown in FIGS. 25-28, for example, the second cavity 304 is located on a base tray 1004, and the base tray 1004 is removably coupled to the first cavity, and the second cavity 304 is also removably coupled to the base tray 1004. In particular, the tray structure 1004 has internal threads that mate with external threads 3031 extending from the bottom of the first cavity 303 to enable removable combination of the tray structure 1004 with the first cavity 303. Thus, if there is also a connecting channel, as shown in FIG. 27, the connecting channel 309 may still have a first opening 3091 in fluid flow with the first cavity and a second opening 3092 in fluid flow with the second cavity, and the connecting channel may have an extension 3098 that extends into the opening 3052 of the second cavity, contacts the inner wall of the opening 3041, and may snap together, i.e., the outer diameter of the extension area matches the inner diameter of the opening 3041. Although the second chamber and the first chamber may also be snap-connected via the connection channel 109 as in fig. 27, this connection does not require a very strong connection and does not require as tight a connection as in fig. 8-9 (by means of threads, etc.), since the tray structure 1004 is engaged by the threads 10041 with the external threads 3031 of the extension of the first chamber 103, which does not cause leakage problems between the connection channel 109 and the second chamber opening 1042, no matter how much liquid sample is collected by the second chamber 304. Therefore, the inner diameter of the connection channel 109 may be smaller than the inner diameter of the opening 1042 of the second chamber, which allows the connection channel to be inserted into the opening 3042 of the second chamber in a manner that allows easy insertion (shown in FIG. 27). But only the outer edge of the opening 3042 is provided with threads for the closure of the second cover (see fig. 27). At this time, the connection of the connection channel and the opening of the second chamber is sufficient to ensure that no leakage occurs when collecting the liquid sample, i.e. to allow the liquid to enter the second chamber, without further structural restrictions. The connection can be in the forms of clamping connection, piston type connection and locking connection. In practice, having the first chamber detachably combined, joined or joined with the second chamber is accomplished in an indirect manner.
After the collection is completed, the sealing of the connection channel or/and the draining of the second chamber is performed according to the method described later, and if a second confirmation test is required, the tray structure 1004 is separated from the first chamber 103, for example, by reversely screwing the tray to match the threaded structure of the bottom of the first chamber, at this time, the second chamber 104 located on the tray is also separated from the first chamber 103 together with the tray structure, as shown in fig. 27, at this time, the second cover 101 is removed to cover the opening 3042 of the second chamber, and then the second chamber is separated from the tray 1004 (as shown in fig. 29), because the bottom of the second chamber has the snap-fit structure 10042 with the bottom of the tray, so that the tray and the second chamber are separated from the first chamber 103 together. The tray 1004 is then detached from the second cavity 304 and the tray 1004 is then separately attached to the first cavity 103 and assembled. At this point, the integrity of the first chamber is maintained, while the second chamber may be sent to a confirmatory assay mechanism for a secondary confirmatory assay. In order to allow the second cavity 304 to disengage from the first cavity as the tray moves, a snap ring 10042 is provided on the tray, which snap ring is shaped to accommodate the cavity shape of the second cavity 304, e.g. the cavity of the second cavity is U-shaped, and the snap ring 10042 is also U-shaped, such that the tray structure 1004, when rotated, brings the second cavity 304 to rotate together, and the second cavity 304 and the tray structure 1004 together disengage from the first cavity 303 as the second cavity and the snap ring may mate slightly tightly. Of course, in some modes, the second cavity is of a cube-like structure, 4 buckle structures are arranged on the tray, and the second cavity and the buckle structures are clamped together, so that the movement of the tray drives the movement of the second cavity, and the separation of the second cavity and the first cavity is realized.
At this time, in order to ensure the safety property of the second cavity after the second cavity is covered by the second cover, a seal may be attached to the second cavity, and the seal covers the second cover and a part of the second cavity. The sample in the second cavity is not replaced maliciously, so that the liquid in the second cavity is kept consistent with the original sample in the first cavity. Of course, alternatively, the tray 1004 and the second cavity may be packaged and transported together, with the seal covering the second cavity and the tray and the cover sealing the second cavity, thereby forming an integral structure for transportation. It will also be appreciated that the base structure 1004 and the second cavity 104 are integrally formed and formed by injection molding, so that when the base 1004 is combined with the first cavity 104, the second cavity 104 is also combined with the connecting channel 109.
Alternatively, the connecting channel and the extending section 3098 may be omitted, because only a hole needs to be formed at the bottom of the first cavity 103, and the size of the hole is smaller than or equal to the opening 3042 of the second cavity 304, and the connecting channel does not need to have an extending section (as shown in fig. 27), the first opening 3091 of the connecting channel may function as a bottom hole, so that when the second cavity is combined with the first cavity by the tray, the opening 1042 of the second cavity corresponds to the position of the bottom opening (similar to the position 3091 shown in the drawing) of the first cavity 103, and by virtue of the cooperation of the tray 1004 with the first cavity 303, the opening of the second cavity 304 forms a tight fit with the area around the hole, or forms a tight contact, so that the second cavity forms a liquid communication state with the first cavity, and when the first cavity collects liquid, the liquid also flows into the second cavity. If it is desired to separate the first cavity 103 from the second cavity, the hole in the bottom of the second cavity (similar to the position shown at 3091 in FIG. 27) is sealed, thereby allowing the tray 1004 to be separated from the first cavity 103, and thus also allowing the second cavity 103 to be separated from the first cavity together. The same function is also achieved. Optionally, the aperture is initially sealed with a readily penetrable sealing material, and after collection of the liquid, or after initiation of the test, the sealing material is pierced to allow the liquid to flow into the second chamber, in a manner to seal the element, as will be described in more detail below.
After the first cavity liquid collection is finished, the second cavity and the first cavity can be separated, so that the second cavity can be stored or transported to a detection mechanism for secondary confirmation detection, the liquid in the first cavity can be used as first time or primary detection, or after the first cavity liquid collection is finished, the second cavity and the first cavity can be separated, the liquid in the first cavity is subjected to primary detection after separation, after detection results are obtained, the separated second cavity can be stored or directly transported to a detection structure for secondary confirmation detection, or after the liquid sample collection is finished, the liquid sample in the first cavity is detected, after the primary detection results are obtained, the second cavity and the first cavity are separated, and the separated second cavity is used for storage or subsequent secondary confirmation detection.
Of course, the liquid in the first chamber may be stored, and the first detection may take place at a suitable time. In some preferred forms, it is desirable to collect the liquid in the first chamber and then perform a corresponding primary or first test, and after the test results are completed, perform a secondary confirmation test on some of the primary test results, if necessary. Once the primary test is merely a preliminary test for the presence of an analyte in the sample, the sensitivity of the test is generally not high, and sometimes the result of the primary test does not give a positive or negative result when the analyte in the sample is at a critical threshold, a secondary confirmatory test is desired on the same portion of the sample.
As to whether the second chamber or the first chamber is used for confirming the secondary detection after the separation of the first chamber and the second chamber, for example, the first chamber may be used for the secondary detection, and the liquid sample in the second chamber may be used for the primary detection. Therefore, the first chamber and the second chamber are not limited to the second chamber only for confirmation detection. In some aspects, such as shown in fig. 37 and 38, the present invention provides a first chamber 603 for collecting a liquid sample and a second chamber 604 for performing an initial test, the second chamber having a test chamber 605, the test chamber and the second chamber having a liquid communication through hole 6038. The first chamber has an opening 6031 and at the bottom of the first chamber there is a connecting channel 609 with a first opening 6091 in fluid communication with the first chamber and a second opening 6092, wherein the first opening is sealed by a sealing element, which is a shell-piercing sealing element, e.g. a film, double sided tape, aluminum foil or the like. Thus, when the first chamber is used for collecting a liquid sample, the liquid does not initially flow out through the first opening of the connecting channel. When the first chamber is collected with a liquid sample, it is combined with the second chamber, for example by means of the external screw thread 6031 of the first chamber and the internal screw thread of the second chamber, or the first chamber and the second chamber are initially combined by means of screw threads, and the liquid sample is collected directly with the first chamber 603. When the collection is completed, the sealing element with the seal 6028 and the puncture element 6029 is used for puncturing the first opening of the sealing connection channel, liquid is released to the second cavity 604 for primary detection, the liquid enters the detection cavity 605 for primary assay detection, when secondary confirmation detection is needed, the first cavity is detached from the second cavity, the opening of the first cavity is sealed by the cover body, and therefore the liquid sample in the first cavity is subjected to secondary confirmation detection. Optionally, the cover for sealing the first chamber includes the sealing element 6028 and the piercing element 6029, and the first chamber has an extending channel 610 corresponding to the first opening 6091 of the connecting channel 609, and the channel extends into the first chamber, so that when the cover covers the first chamber, the cover and the sealing element 6028 and the piercing element 6029 form a linkage relationship, and thus the sealing element and the piercing element are moved together, and when the piercing element pierces the first opening 6091 of the connecting chamber, the sealing element pushes the liquid in the channel 610 to flow into the second chamber for performing the primary assay, and the cover seals the opening of the first chamber. As shown in the upper diagram of fig. 38. When it is desired to perform a second assay, the first chamber 603 is disengaged from the second chamber 604, and then a second opening of the connecting channel, such as by means of a screw thread, is sealed with a second cap, and then the first chamber 603 is sent to a detection mechanism for a second confirmatory test, as shown in the diagram below in fig. 38.
Of course, the puncturing element can also have the function of removing part of the liquid in the second cavity, and in this case, the puncturing element can also be provided with a lyophobic channel, a liquid inlet and a containing cavity. Thus, upon piercing the first opening 7091 of the sealed attachment passageway, the piercing element is partially inserted directly into the second chamber, and for the purpose of removing liquid, liquid may be allowed to flow into the receiving chamber through the liquid inlet of the lyophobic passageway, e.g., the receiving chamber is located within the piercing element, as will be clearly understood and appreciated in conjunction with the detailed description that follows.
In some alternatives, the collection device may also include a test element to test the collected sample when used as a detection device. For example, the collection device comprises a detection chamber, wherein the detection chamber is in fluid communication with the first collection chamber, i.e. a liquid sample located in the first chamber may flow into the detection chamber. Of course, the detection device herein comprising a detection chamber is only a preferred embodiment, and the detection chamber may be absent when used as a collection device, or the detection device may comprise a detection chamber, but without a test element, etc. the detection element may be inserted into the detection chamber when detection is desired. In some embodiments, the detection chamber 105 is disposed outside the sidewall of the first chamber, the first chamber 103 and the detection chamber 105 are in fluid communication (as in fig. 9), and if a liquid sample is present in the first chamber 103, the liquid can be in fluid communication through the through-holes 1038 provided in the detection chamber 105 and the collection chamber 103, and thus enter the detection chamber for performing the necessary primary assay or detection.
In general, the sensitivity of detection of the liquid sample in the first chamber 103 (first or primary detection) is not as high as that of the secondary confirmation detection, or the specificity of the first or primary detection is not as accurate as that of the secondary confirmation detection. The secondary detection can basically confirm whether the primary detection is truly accurate. For example, primary detection is performed by immunological or chemical methods, while secondary confirmation detection is typically performed by mass spectrometry (GS), gas or liquid chromatography. Such secondary tests are typically performed with the liquid sample in a second chamber separate from the first chamber, since both the first and second chambers are directed to the same sample, and they are of the same nature, but separated into different portions, and the secondary test can confirm the primary test.
In some preferred forms, the liquid in the first chamber 103 is detected at the same time as or shortly after the collection of the liquid sample. Thus, in a preferred form of the invention, the first chamber 103 and the detection chamber 105 are in fluid communication, the detection chamber including a test element therein. In some preferred embodiments, the test elements are disposed on a carrier. In a preferred form, the test chamber includes a test carrier 106 having a plurality of card slots 1061, each of which has a test element disposed therein. For example, as shown in FIG. 9, when a liquid sample is collected in the first chamber 103, a part of the liquid sample flows into the detection chamber 105 through the through hole 1038, the liquid sample flowing into the detection chamber contacts the test element, and thus detection of the analyte is completed, and another part of the liquid sample flows into the second chamber 104 through the opening 1091 of the connection passage 109. When the test element in the test chamber has finished the test, the primary test result is read, and after the reading, it is felt that it is necessary to perform a confirmation secondary test, the second chamber 104 is separated from the first chamber 103, and then the opening 1042 of the second chamber 104 is sealed with the second cover 101, and the second chamber 104 is stored or directly sent to the test structure for confirmation test to perform a further confirmation test. While the liquid in the first chamber 103 and the detection chamber 105 where the first detection is performed may be discarded or processed.
The method adopts a mode of separating primary detection and secondary confirmation detection, thus overcoming some defects of the traditional detection equipment. In the conventional test device, if a secondary test is required after the test is completed, the whole test device (with the first chamber as a chamber for collecting liquid and/or with the test chamber, or the test element in the test chamber) is stored, or the whole test device is packaged and transported (e.g. on the land of an automobile, sea or air) to the secondary test mechanism for confirmation test, so that any structure of the whole test device is ensured or ensured, no leakage liquid sample can be leaked at any place, because the leakage of the sample causes external pollution, and the samples are mutually polluted, thereby bringing uncertain results to confirmation or secondary detection. This tends to seal each and every structure that may cause leakage, which adds significant cost and design difficulty to the manufacture of such devices, since these primary devices are typically plastic articles and are disposable, and it is difficult, if not impossible, to achieve a device that does not cause leakage of liquid under any circumstances, but does require significant manufacturing costs. Ideally, on the one hand, the cost is reduced as much as possible, and at the same time, the liquid sample needs to be ensured not to leak, which brings great challenges to manufacturers. For example, this requires a complex design of the first cover 102 sealing the opening 1031 of the first chamber, ensuring that liquid cannot leak out through the opening 1031. If the device also includes a test element, this requires more precise machining or design of the cavity (if any) in which the test element is housed, ensuring that the liquid sample cannot leak out through the test cavity, and in particular, these devices typically require air transport without leaking under negative or high pressure, presenting a relatively great challenge to manufacture and design. Conventionally, a seal ring or a silicone gasket is always used as a sealing component to avoid leakage, but once the storage time of the device is relatively long, the silicone or plastic is oxidized or aged, and leakage of liquid is caused during use. Secondly, if the samples of the primary test result need to be stored, more storage space is required to accommodate a large volume of test device, which inevitably increases more space, and the number of samples to be tested is very large for a professional testing organization, which requires enough space to store the samples to be tested, which are accommodated in a larger test device, requiring a larger area or volume for the storage space. third, the devices for the first detection are large, so that the transportation cost is increased significantly, the cost for transportation and packaging is increased, and after all, the traditional detection devices are large and are packaged and transported separately. Fourth, if the test device initially has a test element, the collected fluid will always contact the test element during transport, and the test element will contain chemicals that are not present in the fluid sample itself, and long-term contact of the fluid sample with the test element will cause contamination of the fluid sample and may negatively affect subsequent secondary testing. In any case, the conventional detecting device or collecting device has one or several of the drawbacks described above, for whatever reason.
With the device of the invention, the volume of the second chamber is typically smaller than the volume of the first chamber, even by a tenth or a fraction of the volume of a conventional detection chamber. The second chamber typically requires only 1-50 ml of sample to perform a secondary assay, for example, 0.1 ml, 0.2 ml, 0.3 ml, 0.4 ml, 0.5 ml, 0.6 ml, 0.7 ml, 0.8 ml, 0.9 ml, 1 ml, or only 1.2 ml, 1.4 ml, 1.6 ml, 1.8 ml, 2 ml, or only 3 ml, 4 ml, 5ml, 6 ml is sufficient, 7 ml, 8 ml, 9 ml, 10 ml, 11 ml, 12 ml, 15ml, 25 ml, 30ml is required. The volume of the first chamber is typically 5-500 ml, e.g., 8 ml, 10 ml, 12 ml, 14 ml, 16 ml, 18 ml, 20 ml, 22 ml, 24 ml, 26 ml, 28 ml, 30ml, 32 ml, 34 ml, 36 ml, 38 ml, 40 ml, 42 ml, 44 ml, 46 ml, 48 ml, 50 ml, 60 ml, 70 ml, 80 ml, 100ml, 150 ml, 200ml, 250 ml, 500 ml. Moreover, in general, the second chamber has only one opening 1042, and it can be confirmed that the sample is not leaked as long as the second opening 1042 is sealed. On the one hand, the second cavity is small in size and light in weight, so that the cost of transport package is remarkably reduced, and the storage space is small. On the other hand, it is not necessary to have as high a sealing requirement as in conventional devices for the first chamber and/or the parts containing the detection chamber, for example the sealing requirement for the first cover to seal the opening 1031 of the first chamber is much lower, and the sealing requirement for the detection chamber provided by the test element is much lower than in conventional devices, even irrespective of whether the first cover has a sealing effect on the opening of the first chamber 103 or not, and also differently regarding the sealing effect of the detection chamber itself, since the first chamber 103 and/or the first chamber with the test chamber 105, even the first cover 102, can be discarded once the initial detection has been completed. Compared with the traditional disposable detection device, the device saves a great deal of cost and is safer and more reliable. In addition, the property of the liquid in the second cavity is consistent with that of the first cavity, so that the efficacy property of the secondary detection is ensured. Third, because the second chamber is small, need not take into account the storage space in particular, a large amount of second chambers can be stored in very little place, have reduced the pressure of confirming the laboratory, have reduced the transportation cost too, can guarantee the security of transportation simultaneously. As there is no need to worry about the risk of liquid leakage.
In some preferred forms, when it is desired to perform the test on the liquid sample collected in the first chamber 103 and to collect the secondary confirmation sample in the second chamber 104 at the same time, it is desirable that the sample flowing into the test chamber (if there is a test chamber) does not potentially contaminate the liquid sample entering the second chamber 104, and the opening 1091 of the connecting channel 109 is positioned at a level higher than the height of the through hole 1038 (e.g., as shown in fig. 7 and 6, and as shown in fig. 9), so that the liquid flowing into the test chamber does not or hardly enter the second chamber, thereby ensuring that the liquid in the second chamber 104 is substantially the same as the liquid sample that does not contact the test element. After all, the liquid sample in contact with the test element may contain some chemical agent or other component that has been processed on the test element, which may adversely affect the results of the second test if such agent or component enters the second chamber. It will be appreciated that the opening 1091 with the connecting channel is higher than the through hole 1038, or the opening through which the liquid flowing into the second chamber passes is higher than the position of the through hole flowing into the detection chamber (e.g., the bottom hole of the previous embodiment, which is not provided with a receiving channel) as described above, so that the liquid sample contacting the test strip can be prevented from entering the second chamber when the test element is included in the device and is in contact with the liquid sample.
In some preferred forms, the first chamber contains pooling areas 1035 or 1036 for pooling liquid, which pooling areas are located at the bottom of the first chamber 103 around the perimeter of the connection channel 109 or around the connection channel first opening 1091. In some preferred embodiments, these pooling areas are positioned below the position of the connecting channel opening 1091 so that when liquid enters the first chamber, it pools in the pooling areas and then contacts the test element in the detection chamber through the through hole 1038. Thus, in the order of liquid arrival, the pooling area is reached by the liquid prior to flowing into the through hole 1038 into the detection chamber (if present) before reaching the position of the first opening 1091 of the connecting channel.
In some preferred forms, for example, as shown in fig. 12, 4, 5, there is a raised area in the middle of the bottom of the first cavity that creates a space to accommodate part of the body structure of the second cavity 104. The connection channels or holes are provided in the raised areas which also form a converging area u (shown in fig. 4 and 5) which is recessed into the first cavity 103 from the bottom of the first cavity (e.g. fig. 4), which recessed area serves to accommodate a part of the area of the second cavity 104 within the opening 1042, so that the material of the detection device as a whole is not additionally increased nor is it obtrusive, as shown in fig. 7-11, and the opening of the second cavity is provided under the bottom of the first cavity 103, which is still, as a whole, inferior to conventional detection devices. In some preferred forms, the pooling areas 1036 and 1035 are positioned below the position of the through-hole 1038 such that pooled liquid sample is first allowed to pass through the through-hole 1038 into the detection chamber (if present) 105 and, as long as the detection chamber is filled or the through-hole 1038 is liquid-sealed, excess liquid is allowed to pass through the first opening 1091 of the connecting channel 109 into the second chamber 104. This prevents as far as possible liquid flowing into the detection chamber from exiting the detection chamber into the second chamber. Or in the order of liquid flow, the liquid generally reaches the collecting area to collect, and after the liquid is collected to a certain height, the liquid flows into the detection cavity through the through hole 1038 to perform a test, and after the liquid sample is collected in the detection cavity, the through hole 1038 is sealed by the liquid, and along with the increase of the liquid, the liquid level reaches the position of the connecting channel opening 1091, so that the liquid enters the second cavity, and the second cavity is filled with the liquid sample or part of the liquid sample enters the second cavity to be used as a subsequent secondary confirmation detection.
In other embodiments, the test device does not include a separate test chamber (as schematically illustrated in fig. 1), such as shown in fig. 15-17, including a region on the sidewall in the first chamber 203, such as shown in fig. 16, where the first chamber 203 includes two vertical strips 2032 and 2033 that define a region into which a carrier such as shown in fig. 17 is inserted to form a structure with test functions. For example, as shown in FIG. 17, a carrier structure is provided with a plurality of channels 2063 for receiving test elements, the channels having one end 2062 closed and the other end open 2061, each of the channels being arranged in such a compatible orientation on the carrier, the detection zone and the water-absorbing zone on the test elements being located in the channels, and the sample application zone on the test elements being located at one end of the channel opening 2063, the test elements in each of the channels being so arranged that the sample application zone of the test elements in each of the channels is located at the end 2065 of the carrier, and the detection zone of the test elements is located at the end adjacent to the channel seal and at the top end 2064 of the carrier. In assembling the carrier into the first cavity 103, the end 2065 of the carrier is positioned adjacent the bottom 2034 of the first cavity and the top 2064 of the carrier is positioned adjacent the opening 2031 of the first cavity. Thus, a portion of the sample of the liquid sample entering from the opening of the first chamber 203 contacts the sample application area of the test element near 2034 the bottom of the first chamber 203, thereby completing a test assay for the analyte in the liquid sample. In other preferred forms, such as shown in fig. 25-30, the removable combination of the second chamber 304 and the first chamber 303 may be implemented in any of the ways previously described, such as in fig. 1, 6-13, or any of the ways previously described, including sealing or separating in any of the ways subsequently described.
In some preferred forms, the bottom 2034 of the first cavity has a configuration of grooves 2035, the grooves 2035 allowing the collection of liquid templates in the first cavity, as shown in FIGS. 22 and 23. In some preferred forms, the height of the first opening 2091 of the connecting channel 209 is greater than the height of the recess, i.e., the opening 2091 of the connecting channel 2091 is upstream of the recess 2035, so as to prevent liquid sample in contact with the test element in the vicinity of the recess from flowing through the first opening 2091 of the connecting channel 209 into the second chamber 204. Also, when the test element in the carrier in the first chamber is subjected to the primary or first test and it is considered necessary to perform the subsequent secondary confirmation test, the second chamber may be separated directly from the first chamber, and after separation, the opening 2041 of the second chamber 204 may be sealed with the second cover 201 for separate storage, or may be packaged separately for transportation to the second confirmation test structure for confirmation test. Correspondingly, the carrier 206, which has been subjected to the initial detection, is discarded or disposed of together with the carrier next to the cavity 203 and the first cover 202 with the opening 2031 sealing the first cavity 203. The volume of the first chamber is generally greater than the volume of the second chamber, and they may be designed as described above, although the volume of the first chamber may be equal to the volume of the second chamber, and optionally the volume of the first chamber may be less than the volume of the second chamber.
In some modes, there is no particular limitation on the shape of the first cavity and the shape of the second cavity, for example, generally, the shape of the first cavity is cylindrical, and the shape of the second cavity is cylindrical, of course, the shape of the first cavity may be rectangular parallelepiped, square, ellipsoid or cone, and correspondingly, the shape of the second cavity may be rectangular parallelepiped, square, ellipsoid or cone.
The foregoing teaches the removable manner of the first and second chambers, typically with the second chamber being located within or at the bottom of the first chamber, or initially, the first and second chambers being combined together, typically after the liquid has been collected, to separate the first and second chambers. Of course, the particular location of the second cavity is not limited and the second cavity may be otherwise.
Sealing element
In some preferred forms, after or immediately before or during separation of the first and second chambers, which were originally in fluid communication, are not in fluid communication, thereby preventing fluid communication between the first and second chambers. Or whether the first cavity and the second cavity are communicated with each other or not is judged by the following states, wherein the first state is not communicated with the liquid, and the second state is not communicated with the liquid, or the first state is communicated with the liquid, and the second state is not communicated with the liquid. The second chamber and the different conditions of the second chamber during different purposes or operations, whether in liquid communication or not, may be designed and selected at will. For example, when the first chamber collects a fluid sample or a liquid sample, the first chamber and the second chamber are in fluid communication, and when separation is required, the second chamber is not in fluid communication with the first chamber. When the first cavity is required to be separated or separated, the second cavity is not in liquid communication with the first cavity, so that the second cavity collects liquid from the first cavity, and then the first cavity and the second cavity are not in liquid communication, so that the second cavity is separated and separated from the first cavity.
Thus, in some embodiments, a sealing element is provided that seals the connecting channel if the first chamber 103 is removably combined with the second chamber 104 via the connecting channel 109, and does not allow liquid from the first chamber to re-enter the second chamber, or does not allow liquid from the first chamber to exit through the channel of liquid entering the second chamber. The connection may be made indirectly through the connection channel or may be made without the connection channel, so that the connection channel is sealed or the connection between the first and second chambers is substantially sealed, in any case, in these embodiments, the connection between the first and second chambers is sealed by the liquid after or simultaneously with the separation of the second chamber from the first chamber or before the separation, so that the liquid does not leak out of the first chamber through the connection after the liquid enters the second chamber or after the separation of the second chamber. In some preferred embodiments, the liquid cannot leak through the junction to the environment of the first chamber containing the test element or the liquid cannot leak through the junction to the environment of the first chamber containing the test element. It will be readily appreciated that when the connection and fluid communication are not achieved by the "connection channel" of the preferred form of the invention, but rather by two separate structures of the connection structure and the communication channel, once the first and second chambers are separated by the connection structure, fluid flow is achieved by sealing the communication channel with the sealing element. The function of the sealing element is therefore to leave the first and second chambers in a state in which they are not in fluid communication, changing from a state in which the fluid is flowing to a state in which the fluid is not flowing.
In some preferred forms, the connecting channel is sealed by the sealing element when the second chamber is detachably connected to the first chamber via the connecting channel, before, after or simultaneously with the separation of the second chamber from the first chamber. The sealing element may seal the first opening 1091 of the connecting channel as described in fig. 12. Here, the sealing element, like a plug, blocks the opening 1091 of the connection channel, thereby preventing liquid from entering the second chamber or from flowing out of the first chamber from the first opening 1091 of the connection channel. The sealing element may here be adapted or adapted to the shape of the opening of the connecting channel, so as to seal the connecting channel. By compatible is meant that the sealing element and the connecting channel cooperate with each other by means of one or a combination of suitable dimensions, suitable materials, suitable shapes to function as a liquid seal. For example, the first opening of the connecting channel may be circular, the sealing element may be circular, or the connecting channel may be plastic, the sealing element may be plastic, sealed by means of the mechanical elasticity of the material itself, or the sealing element may be rigid, the connecting channel may be elastic, or the sealing element may be rigid, the rigidity of the connecting channel may be achieved, and the above-described functions may be achieved. For example, the sealing element is elastically deformable, while the connection channel is rigid, and the sealing element is plugged into the connection channel, thereby sealing the opening of the connection channel. The sealing mode can be arbitrarily selected. The sealing element may be used alone to seal the connecting channel or to seal the first and second chambers in fluid communication.
In some preferred forms, the first cover 102 includes a sealing element thereon that seals the opening of the connecting channel while the first cover covers the opening of the first cavity. In effect, the sealing element and the cover form a linkage mechanism, and movement of the cover moves the sealing element. The movement of the first cover body is used for sealing the opening of the first cavity, and if the first cover body moves, the sealing element can also seal the connecting channel at the same time, so that the operation is more convenient. It is understood, of course, that the first cover body covers the first cavity and the sealing member seals the connecting channel, and is not linked, and can be completed in two steps, which is also within the scope of the present invention. Preferably, the sealing element seals the first opening of the connecting channel. It is also possible that the movement of the first cover and the change of the state of bringing the first chamber and the second chamber into fluid communication are accomplished in linkage. For example, movement of the first cover, during movement, causes the first and second chambers in fluid communication to change to a state in which the first and second chambers are not in fluid communication. Or the first cover body moves to change the state that the first cavity and the second cavity are not in liquid communication into the state that the first cavity and the second cavity are in liquid communication, and the first cavity and the second cavity are not in liquid communication along with the movement.
The cover may be a cover that cooperates with the first cavity to cover the opening 1031 of the first cavity, or may be a cover that seals the opening 1031 of the first cavity 103, where the seal may be a general seal or may be an unsealed state, and only prevents the liquid sample from spilling out of the first cavity, for example, when the first cavity is moved, the liquid is prevented from spilling out of the opening 1031 of the first cavity. As described above, the closing of the first cover with the opening of the first cavity does not require the sealing effect as in conventional detection devices, as the whole detection device does not need to be transported or transported under extreme conditions. When the sealing element is on the cover and the first cavity collects a sufficient amount of liquid, the cover is generally required to cover the opening of the first cavity, and when the cover is covered on the opening 1031 of the first cavity, the sealing element connected to the cover seals the opening of the connecting channel or the connecting channel at the same time, so that the liquid cannot enter the second cavity, and after the second cavity is separated from the first cavity, the liquid cannot leak into the outside through the connecting channel. Thus, the operation is more convenient, simple and quick, and two functions are completed while the operation is performed in one step. The sealing effect of the sealing element here for sealing the connection channel can only be such that liquid is temporarily not allowed to leak through the connection channel to the outside, without the sealing effect being required as in conventional test devices, ensuring that leakage is not possible under extreme transport conditions, such as high pressure or vacuum. This is also because the sample in the second chamber is used as a carrier for the secondary confirmatory test, and the liquid in the first chamber does not have to be transported or stored and can be discarded later. Therefore, the sealing of the opening 1031 of the first chamber and the connection channel or the connection channel opening 1091 is only a general sealing, and does not need a sealing state under a negative pressure, vacuum state as in the conventional device. Mainly because there is no need to transport the fluid in the first chamber in communication with the first chamber to a professional laboratory or assay facility for a secondary assay.
For convenience and low production cost, the first and second chambers are all of plastic material, and these are injection molded in one step, and the sealing element and the first cover are also injection molded, and the connection between the sealing element and the second chamber can be sealed by the sealing element depending on the physical properties of the plastic material, preferably, the connection channel for sealing the first and second chambers. To achieve a better sealing effect, an elastic sealing ring 108, such as an "O" type sealing ring, for example a silicone sealing ring, may be provided on the sealing element, which sealing ring is flexible with respect to the material of the sealing element, so that the sealing effect is increased when the sealing element seals the first opening 1091 of the connection channel. It will be appreciated that when it is desired to have the cap and sealing element co-operate, typically the openings of the first cap and first chamber are threadably engaged, the first being the opening of the first chamber of the cap in a rotational manner, and the sealing element also being in a rotational manner to access the connecting passageway or seal the opening of the connecting passageway or seal the aperture through which the first and second chambers are in fluid communication (if the connecting passageway is omitted).
It will be appreciated that the "O" ring and the sealing element are used in combination, and the "O" ring may be produced separately and then assembled to the sealing element, thus having a sealing function, and of course, the structure of the "O" ring may be made of the same material as the location where the "O" ring is installed, but may be made by injection molding at one time, thus facilitating the production and processing process. Of course, in other cases, the O-ring may be default, and the sealing may be achieved only by virtue of the different materials of the connecting channel and the sealing element.
In some preferred embodiments, the sealing element may be injection molded in one piece when it is attached to the first cover, or may be removably attached to the cover. For example, as shown in fig. 2 and 3, a sealing element 1028 is attached to the first cover, a sealing ring 108 is disposed on the sealing element, and the sealing element is integrally formed with the cover 102. In order to better fix the sealing ring, a groove structure is arranged on the sealing element, so that the sealing element is elastically fixed on the groove. Typically, the first chamber needs to hold a certain volume of liquid sample, so it has a certain volume, so the opening 1031 of the first chamber is at a distance from the first opening 1091 of the connection channel at the bottom of the first chamber, so the sealing element is connected to the cover 102 by the connection structure 1023 to form a unitary structure. As shown in fig. 12, when the cap is closed to the opening 1031 of the first chamber by means of closing, for example, rotation, the sealing member 1028 integrally formed with the cap is also rotated together into the connection passage 109, and then the sealing member is introduced into the connection passage during the closing process of the cap, so that the sealing member 1028 seals an opening 1091 of the connection passage, thereby preventing the liquid sample from being introduced into the first chamber, and when the second chamber is separated from the first chamber, the liquid sample in the first chamber is not leaked to the outside through the connection passage.
For example, as shown in FIG. 22, the first cover 202 has a connecting structure 2023 attached thereto, the connecting structure 2023 extending a length to serve as a sealing member 2028 to seal the connecting channel. In the condition shown in FIG. 22, when the sealing member 2028 (i.e., the portion 208 with the sealing ring) is not yet adjacent to the opening 2091, the first and second chambers are in fluid flow condition. As the position of the cap changes, the sealing element is positioned adjacent to the opening 2091, and as it moves, the sealing element seals the opening 2091, thereby achieving a seal, and the fluid in the first chamber does not flow into the second chamber.
It is preferable that the cap and the sealing member are interlocked so that the first chamber and the second chamber are not in liquid communication. The cover body and the sealing element can be injection molded at one time, or can be assembled together by multiple injection molding. For example, the cover is injection molded once, and the connecting rod 2023 and sealing element 2028 are injection molded once, and then joined together by any optional mating, threading, or other means, such that movement of the cover moves the sealing elements together, known as "linkage". In a further form, it is also possible that the sealing element, the connecting rod and the cover are injection moulded separately and then assembled together.
In some preferred embodiments, the sealing element is therefore also detachably connected to the cover. 31-35, the cover 402 includes a sealing element 4028 that matches the shape of the connecting channel or the shape of the first opening 1091,3091, such as the shape of a piston. In this way, a portion of the connection structure 4023 is used as the sealing member 4028, and at this time, has no sealing ring. But the material may be different and the material of the sealing element is generally more elastic, so that the elastic sealing element seals the connecting channel or the first opening of the connecting channel more easily, even without the sealing ring. For example, the sealing element may be made of latex, silica gel, or other elastic material, or the sealing element is made of two parts, wherein the inside is made of a relatively hard material, and the surface of the hard material is covered with a layer of elastic silica gel, rubber, latex, or other material to enhance the sealing effect between the sealing element and the connecting channel or opening 1091. At the same time, when the first cover 402 covers the opening of the first chamber 103,203, less effort is required to seal the connection channel or opening with the sealing member 4028, for example, to seal the connection channel by allowing the sealing member to enter the connection channel. Or the sealing element 5029 (when the structure of 5029 is adopted as the sealing element) and the connecting rod 5023 are connected together through threads, for example, fig. 33-34, in this embodiment, one end 5030 of the sealing element 5029 is provided with external threads, one end on the connecting structure 5023 is provided with internal threads, and the sealing element is connected with the cover body into an integral structure through a thread form, so that the sealing element can be made of different materials with the cover body and the connecting structure, and the sealing element has more design forms and modes to meet different sealing requirements.
The seal may be a separate component or may be provided where the second chamber is connected to the first chamber, to block fluid flow between the second chamber and the first chamber. The flow here is typically an active flow. In fact, the sealing element is not necessary when the liquid passively flows from the second chamber to the first chamber.
Also, as previously taught in connection with FIG. 27, when there is virtually only one aperture, such as 3091-like aperture, in the first and second chambers without the connecting channel-extending portion 3098, the sealing member need only seal the opening 3091 and does not have to be passed into the connecting channel. For example, a sealing element such as a rubber plug, is provided on the connecting rod 3023 of the cover, and the linkage of the cover brings the plug to plug the opening 3091, effecting a change in the state of fluid communication between the first and second chambers.
Also, the sealing element may initially seal the first opening of the connecting channel, and after the first chamber 103 collects the liquid sample, or before or after the first chamber liquid sample is subjected to a first test, the sealing element is pierced or removed by the piercing element to allow the liquid sample to flow into the connecting channel through the second opening into the second chamber 104, and the second chamber is removably combined with the first chamber to allow the second chamber to be separated from the first chamber for a subsequent possible confirmatory assay test. Thus, when the sealing element is pierced, the sealing element may be of a pierceable construction, for example, such sealing element may be a self-adhesive, double-sided tape, plastic sheet or the like. Typically, the penetrable element does not initially allow liquid to enter the connecting channel, but rather does so after being pierced. The manner in which they are pierced is varied, e.g., by being sharp. In some embodiments, a lancing element can be provided on the first cap 102, with the cap cooperating with the lancing structure, the lancing element sealing the element when the first cap is closed over the opening of the first chamber 103, thereby allowing fluid to flow from the first chamber to the second chamber. If it is desired to separate the first and second chambers, the other sealing element is sealed at the puncture before separation, whereby a change in the state of fluid communication between the first and second chambers is achieved.
For example, as illustrated in fig. 39-40, the first chamber 702 includes an opening 7031 for receiving a liquid sample, and has a hole therein, which is a first opening 7091 of the connection passage, which is sealed 70281 by a penetrable sealing member, and a detection chamber 705 in fluid communication with the first chamber is in fluid communication through the passage 7038. Unlike the first chamber shown in fig. 37-38, which serves as a chamber for collecting a liquid sample for initial detection, a second chamber 704 is detachably connected to the second opening 7092 of the connection channel. When a liquid sample is collected, the liquid portion of the first chamber flows into the detection chamber for initial assay detection, and then the opening of the first chamber is covered with a first cover body, the second cover body is arranged on the cover body, and a sealing element 7028 and a puncturing element 7029 are arranged on the first cover body. The cap and seal 7028 and the lancing element 7029 thus form a linkage mechanism such that when the first cap is closed over the first chamber, the seal and lancing element are driven to linkage, the lancing element now lances the seal sealing the first opening of the connecting channel and then releases fluid into the second chamber, which is then sealed against the opening of the second chamber with the seal. Of course, the puncturing element can also have the function of removing part of the liquid in the second cavity, and in this case, the puncturing element can also be provided with a lyophobic channel, a liquid inlet and a containing cavity. Thus, upon piercing the first opening 7091 of the sealed attachment passageway, the piercing element is partially inserted directly into the second chamber, and for the purpose of removing liquid, liquid may be allowed to flow into the receiving chamber through the liquid inlet of the lyophobic passageway, e.g., the receiving chamber is located within the piercing element, as will be clearly understood and appreciated in conjunction with the detailed description that follows. Such as shown in the upper diagram of fig. 40. When a secondary confirmation test is desired, the second chamber is removed from the first chamber, such as by rotating the threads, and then the second cover is used to seal the opening 7041 of the second chamber 704 for subsequent secondary confirmation tests.
In summary, the flow of liquid from the first chamber to the second chamber may be such that liquid enters the first chamber and simultaneously flows into the second chamber, or such that liquid does not enter the second chamber at the same time or immediately after flowing the liquid sample into the second chamber, as would be the case if the second chamber and the first chamber were not in liquid communication, but rather the second chamber and the first chamber were in liquid communication at any time thereafter. The manner in which fluid communication is not established and in which fluid communication is established is a matter of timing of the sealing element, for example, piercing the sealing element in the first opening 1091 or the second opening 1092 of the sealing connection channel is the manner in which the two chambers are brought into communication. Of course, in order to separate the second chamber without allowing the first chamber liquid to continue to the second chamber, a seal is also required after lancing.
Thus, in some embodiments, the second chamber is placed in fluid communication with the first chamber 104 when no liquid sample is collected, and the second chamber is placed out of fluid communication with the first chamber when liquid is collected or after collection of the liquid sample is completed. Of course, alternatively, when the first chamber 104 is not being used to collect the liquid sample, the second chamber is not in fluid communication with the first chamber, when the liquid is collected or after the collection of the liquid sample is completed, the second chamber is in fluid communication with the first chamber, and when or after the liquid sample is introduced into the second chamber, the second chamber is again not in fluid communication with the first chamber before the first chamber and the second chamber need to be separated. In these ways, the sealing element plays different functions at different times. When to seal or when to unseal, the choice of the time can be made.
In the above example where a sealing element is required, the liquid sample is always free to flow from the first chamber 103 to the second chamber (e.g. gravity force is acting such that liquid always flows from a high position to a low position) and further flow after separation of the two chambers is avoided, but in practice the sealing element is not necessarily required when the liquid sample passively flows from a low position to a high position against gravity force. For example in design 3, no separate sealing element is required.
Lyophobic channel
The term "lyophobic channel" as used herein refers to a channel resembling a liquid drain through which liquid is dredged or drained, and may also be considered as a channel through which liquid flows from one place to another. In addition, the "lyophobic channel" herein may also remove excess gas to relieve pressure, and the passage through which gas is purged or exhausted may also be considered as a passage through which gas flows from one location to another. Therefore, the "lyophobic channel" herein may exclude an excessive liquid, or an excessive gas, or a mixture of gas and liquid. By "channel" is meant, for example, the shape of a tube, for example, a closed perimeter, and comprising two openings, one opening being the liquid inlet and the other opening being the liquid outlet, or one opening being the gas inlet and the other opening being the gas outlet, or one opening being the mixed state inlet for liquid and gas and the other opening being the mixed state outlet for liquid and gas. The inlet and the outlet are only one embodiment, and may of course comprise one or more inlets and may also comprise one or more outlets. The length of the channel itself is not limited, and may be relatively long or relatively short, which can be easily implemented by those skilled in the art according to practical situations.
In some more preferred forms, the seal may be achieved if only the aperture between the first and second chambers is sealed, but if a more effective seal is desired, for example when connecting the first and second chambers using a connecting channel, the connecting channel will typically have an extension 3094 which in fig. 27 extends into the opening of the second chamber, although it is also possible to extend an end distance or length into the first chamber at the connecting channel 3091. To achieve a better sealing effect, the plug-like sealing element is typically inserted partially into the connecting channel to seal the connecting channel, and typically, before sealing the connecting channel, the connecting channel contains a liquid sample, and the second chamber is filled with the liquid sample. this is because the collected liquid sample still requires a sufficient volume to meet the secondary confirmation test and the primary test for the test element. In some preferred embodiments, the liquid level of the liquid sample in the first chamber is therefore higher than the position of the first opening of the connecting channel, i.e. the first opening of the connecting channel is below the liquid level, so that both the connecting channel and the second chamber are filled with liquid. In such a case, a better sealing effect is achieved by the sealing element being partially introduced into the connecting channel, which liquid seal prevents the liquid sample from leaking from the first chamber to the outside after the second chamber is separated from the first chamber. in such a case, the sealing element has a certain difficulty in entering the connection channel, since the sealing element, although of comparable size to the connection channel, must overcome the reaction forces of a certain liquid acting on the sealing element when sealing the connection channel 109. This is because, in order to achieve a better sealing effect, it is necessary to let the sealing element into a part of the connecting channel, so that a better seal is obtained. In order to obtain a better seal, the sealing process is a dynamic process starting from the sealing element close to the first opening of the connecting channel (first state), to the sealing element blocking the first opening of the connecting channel entirely (second state, which is possible, and which is capable of sealing), and then to the sealing element entering the connecting channel (third state, which is the better sealing), in which process, when it is desired to change from the second state to the third state, it is actually necessary to overcome the reaction force of the liquid sample in the connecting channel in contact with the sealing element, in particular to the sealing element entering the connecting channel, forcing the liquid in the connecting channel, and if the liquid cannot be removed, it is difficult to change the sealing element from the second state to the third state. The distance from the first opening of the sealing connection channel to the access connection channel may be 0.1-10 mm, or more, in order to ensure a good sealing effect, e.g. the distance of the sealing element into the connection channel is 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1 mm, 2 mm, 3mm, 4 mm, 5 mm, 6 mm or 7-10 mm. In order to alleviate the reaction force of the liquid, which is the pressure applied to the sealing element by the liquid, the volume of the liquid removed by the sealing element needs to be smoothly removed to another place, so that the reaction pressure born by the sealing element can be relieved, and the sealing element can easily enter the connecting channel. Therefore, when the sealing element enters the connecting channel, a part of the liquid volume in the connecting channel is removed, so that the sealing element can smoothly enter the connecting channel, and the connecting channel or the opening of the connecting channel can be smoothly sealed. This is similar to the way a bottle is plugged into an opening in a bottle, if the bottle is filled with water, the plug is difficult to plug, and it is necessary to have a portion of the water or liquid in the bottle be poured off so that the plug can be plugged into the bottle opening to close the opening. However, when the second chamber is filled with liquid and the connecting channel is also filled with liquid, sometimes the first opening of the connecting channel is located below the liquid level of the first chamber, it is necessary that the sealing element enters or seals the opening of the connecting channel in the form of a piston, which requires that part of the liquid in the connecting channel is removed to another place, it is convenient to let the sealing element enter the connecting channel, preferably when entering, part of the liquid is removed, and the entering of the sealing element is forced by an external force into the connecting channel.
In some preferred embodiments, the device further comprises a lyophobic channel through which the squeezed liquid generated by the connection channel into which the sealing element enters can be discharged out of the connection channel, thereby allowing the sealing element to smoothly enter the connection channel. For example, in some preferred forms, the liquid inlet of the lyophobic channel is located on the sealing member, and as the sealing member enters the connecting channel, excess liquid enters the lyophobic channel through the liquid inlet and is thereby expelled out of the connecting channel. The lyophobic channel may be a place other than the connecting channel and the second cavity detachably connected to the connecting channel, for example, a receiving cavity, for example, a first cavity, or a detection cavity, or other places. Therefore, the device also comprises a containing cavity for receiving liquid or gas from the lyophobic channel. In general, the sealing element seals the connection channel or blocks the first cavity from flowing or flowing with the second cavity, and is generally divided into two states, first, the first cavity and the second cavity are communicated before the sealing element seals the connection channel, and at this time, liquid can be exchanged between the two cavities, and generally, the liquid can naturally flow from the first cavity to the second cavity. Second, when the sealing element starts to seal the connecting channel, for example, the opening of the connecting channel, the first cavity and the second cavity are not communicated, the pressure of the connecting channel and the second cavity is increased due to the fact that the sealing element continuously enters the connecting channel, and the liquid of the connecting channel and the second cavity enters the containing cavity through the liquid inlet of the lyophobic channel due to the effect of the pressure, so that the pressure of the connecting channel is reduced, and the sealing element can seal the connecting channel smoothly. Of course, the lyophobic passages can be arranged at will, and the lyophobic passages are in liquid communication with the accommodating cavity. In this way, liquid that is drained if the sealing element continues into the connecting channel passes through the lyophobic channel into the receiving chamber.
In some embodiments, such as shown in fig. 3 and 2, the sealing member 1028 is used to seal the opening 1091 of the connection channel 109, and the receiving cavity may be located within the sealing member, such as a hollow structure, such that the removed liquid may enter the receiving cavity, and the hollow structure 1029 may be used as the receiving cavity. For example, as shown in fig. 3, the sealing member 1028 further includes a receiving cavity 1029, and when the sealing member enters the connecting channel, the redundant liquid enters the receiving cavity 1029 through the lyophobic channel 1025, so that the pressure is relieved, and of course, the lyophobic channel 1025 is short because the sealing member has a thin wall structure or the sealing member has a hollow structure. Of course, it is easily understood that the receiving cavity is not necessarily located on the sealing element, and when the connecting rod structure 1023 is a hollow structure 1030, the hollow structure 1030 and the receiving cavity 1029 are communicated to form a large receiving cavity to receive the liquid volume removed by the sealing element, or the hollow structure 1030 is used as the receiving cavity, which has an equivalent effect. In some preferred forms, such as shown in fig. 2-3 and 12, the sealing member 1028 seals the opening of the connecting channel 1091 and into the connecting channel 109, while excess liquid enters the receiving cavity 1029 through the lyophobic channel 1025. In such an embodiment, the lyophobic channel has one end opening (liquid inlet) in fluid communication with the liquid in the connecting channel and the other end opening (liquid outlet) in fluid communication with the receiving chamber, so that liquid can enter the receiving chamber, where the lyophobic channel is arranged on the hollow sealing element, so that the lyophobic channel is short, and has a liquid inlet and a liquid outlet regardless of the length. In fact, when the receiving cavity is located in the sealing element or in the subsequent draining element, the liquid inlet and the liquid outlet are not strictly divided, and only when the lyophobic channel is relatively long, the liquid inlet and the liquid outlet are divided, because the sealing element or the draining element is of a hollow structure, the wall is very thin, and a hole is actually formed in the wall, the hole plays a role of allowing liquid to enter the receiving cavity, and when the liquid inlet or the liquid outlet is not necessarily divided, the hole can also be called as the liquid inlet, also can be called as the liquid outlet, and in a word, the position division is not very obvious.
In some preferred forms, as shown in fig. 12, the liquid inlet of the lyophobic channel is located below the sealing member. In some preferred embodiments, the liquid inlet of the lyophobic channel is located on the sealing element and enters the connecting channel earlier than the sealing element, so that excess liquid can be discharged out of the connecting channel, and the reaction resistance of the liquid level borne by the sealing element is reduced. The lyophobic channel may be referred to herein as a through hole in the receiving cavity 1029. Such lyophobic channels may be one or more.
In a preferred embodiment, the liquid inlet of the lyophobic channel enters the connecting channel before the sealing element. Therefore, in some modes, if the lyophobic channel is relatively long, and the first cavity is used as the accommodating cavity, the liquid inlet of the lyophobic channel is positioned on the sealing element, but is earlier than the sealing element enters the connecting channel, so that as the sealing element enters the connecting channel, the discharged liquid enters the lyophobic channel through the liquid inlet of the lyophobic channel, and then enters the first cavity through the liquid outlet of the lyophobic channel or enters the accommodating cavity. Here, the first chamber is a specific way of accommodating the chamber, and the first chamber may be a chamber having a common energy with the accommodating chamber. The receiving chamber is therefore not necessarily located on the sealing element, but preferably is located on the sealing element or in a connecting rod which connects the sealing element to the cover. Thus, as the sealing element enters the connecting channel, excess liquid is expelled out of the connecting channel through the liquid inlet of the lyophobic channel. This removal is the liquid that is forced to be removed due to the pressure on the liquid surface caused by the sealing element entering the connecting channel. Of course, the size of the receiving cavity is related to the liquid removed. So long as a suitable volumetric capacity is provided to accommodate the liquid to be removed.
The positional relationship of the "liquid inlet of the lyophobic channel" will press the liquid sample in the connecting channel if the sealing element needs to enter the connecting channel, in which case the position of the liquid inlet should be located below the sealing element, so-called "below" is merely a relative position and not necessarily on the sealing element. For example, the sealing element can be located on the wall of the connecting channel, when the sealing element enters the connecting channel, the liquid inlet on the wall of the connecting channel is located at the position below the sealing element, and as the sealing element continues to enter the connecting channel, part of liquid is forced to enter the liquid inlet to be removed, so that the sealing element can be smoothly led into the connecting channel. In one case, the sealing element may continue into the connection channel until the sealing element overlaps the liquid inlet on the wall of the connection channel, and liquid cannot enter the lyophobic channel through the liquid inlet, thereby being discharged out of the connection channel. Thus, in some preferred forms, the fluid inlet is located below the sealing element, such as that shown in FIGS. 2-3, and the fluid inlet 1032 is located below the position of the sealing element 1028, the fluid inlet being that of the fluid outlet passageway 1025.
As another example, fig. 15, 18, 22, 23, and 27 show. For example, as shown in fig. 15-24, the seal 2024 and the connecting structure 2023 are integrally formed, the extending portion of the connecting structure serves as the seal, and the entire connecting structure and extending structure are hollow structures 2030,2029, the hollow structures serve as a large receiving cavity, and the liquid inlet 2025 of the lyophobic channel is an opening in the side wall of the extending structure, which is the liquid inlet of the lyophobic channel and is also located under the seal. As another example, as shown in fig. 23, during the entry of the sealing element 2028 into the connecting channel, the inlet 2025 of the lyophobic channel located under the sealing element drains the surplus liquid, thereby reducing the resistance of the sealing element to entry. In some preferred forms, the structure shown in fig. 31 differs from the structure shown in fig. 31 in that the sealing member 3028 lacking the sealing ring 208 is a part of the connection structure 3024 as a sealing member, and in that the connection structure has an opening 3025 at the top end of the extension structure, the opening 3025 communicates with a hollow receiving cavity 2039 in the sealing member, and when the sealing member enters the connection channel, an excessive liquid sample enters the receiving cavity through the lyophobic channel inlet 3025, for example, as shown in fig. 33-35, although the sealing member 4029 is detachably combined with the connection rod 4024, a liquid inlet 4038 is provided at the top end of the sealing member, so as to perform a function of removing the excessive liquid. It will be appreciated that the sealing element is preferably shaped or sized to match the connecting channel for better sealing of the connecting channel, for example, the connecting channel is a hollow structure of circular shape, and the sealing element is also of circular shape, facilitating a sealing engagement therebetween.
With continued reference to fig. 33-35, a connecting rod 5023 is provided on the first cover 502 having a sealing element 5028 that can be used to seal the connecting channel if the connecting channel is sealed with the sealing element 4028 described above, the liquid inlet 4038 of the lyophobic channel is provided at the top end 4029 thereof, and the sealing element 5028 includes a receiving cavity 5030 to collect liquid that is removed from the sealing element entering the connecting channel. Of course, a liquid inlet 5025 may be disposed below the sealing element 5028, and when the sealing element 5028 enters the connecting channel to seal the connecting channel, the redundant liquid enters the accommodating cavity through the liquid inlet 5025, that is, the hollow structure is used as the accommodating cavity 5030. At this time, the member 4029 does not function as a seal, but as a drain, where the extending end 4028 of the connecting rod 4024 is located.
Of course, if instead of using a portion of the structure 5028 of the connecting rod 5022 as a sealing element, the sealing element 5029 is provided on the structure shown at 5035, as shown in fig. 33-35, the sealing element 5029 can be detachably connected to the connecting rod, for example, by plugging, screwing or snap-in. For example, the member 5035 includes an end 5030 having external threads that mate with the internal threads 5027 of the connecting rod. And the sealing member 5029 is matched with the inner wall of the connecting channel to seal the connecting channel. The liquid inlet of the lyophobic channel is disposed at the top end 5038 of the member 5035, when the sealing member 5029 enters the connecting channel, the redundant liquid head enters the accommodating cavity 4029 in the sealing member through the liquid inlet 4038, and the liquid inlet 5025 can be omitted or omitted.
In some preferred embodiments, in order to facilitate the removal of liquid and also to facilitate the efficient entry of liquid into the liquid inlet, the vertical plane of the position of the liquid inlet of the lyophobic channel is located at a position lower than the vertical position of the outermost surface of the sealing element, in other words, the horizontal projection area of the position of the liquid inlet of the lyophobic channel does not coincide exactly with the horizontal projection area of the sealing element, preferably the area of the horizontal projection of the position of the liquid inlet of the lyophobic channel is located within the horizontal projection area of the sealing element. It is to be understood from the further meaning that the sealing element needs to be in contact with the inner wall of the connection channel, whereas the position of the inlet opening of the lyophobic channel is preferably not in contact with the inner wall of the connection channel, since the contact seals the inlet opening, which facilitates the liquid entering the inlet opening of the lyophobic channel and thus being excluded. For example, as can be seen in fig. 2 and 3, the diameter of the sealing element at the position with the sealing ring 108 is larger than the diameter of the position with the liquid inlet 1025, so that the liquid is prevented from entering the lyophobic channel smoothly due to the contact between the position with the liquid inlet 1025 and the inner wall of the connecting channel, and reaches the accommodating cavity. In FIG. 2, the area 1055 of the dashed line is the projected area A-A 'of the sealing element, while the projected area point or area of the inlet 1025 is divided by B, which is located between A-A'. Therefore, according to such a principle, in some embodiments, the sealing element may have an inverted conical structure (the function of the structure will be described later, that is, the function of draining liquid), and the liquid inlet 1025 of the lyophobic channel is located on the surface of the cone, so that the liquid inlet of the lyophobic channel is not in contact with the inner surface of the connecting channel, and the liquid that is conveniently drained enters the liquid inlet of the lyophobic channel to be drained. It will also be appreciated with respect to fig. 18 that the position of the sealing element 2028 is such that the projection of the inlet 2025 at the sealing element 2028 is within the projection of the sealing ring due to the presence of the sealing ring 208. It can be easily understood from fig. 27 that the liquid inlet of the lyophobic channel is formed on the surface of the cone, so that the liquid can easily enter the lyophobic channel, thereby removing the redundant liquid sample. In the case of fig. 31 to 32, for example, where the liquid inlet of the lyophobic channel is provided at the top end position, the case where the liquid inlet of the lyophobic channel is sealed by the side wall of the connection channel is not considered, but the projection satisfying the position of the liquid inlet is the principle of being located in the horizontal projection area of the sealing member. Referring again to fig. 33-34, when the extension end 5028 of the connecting rod 5023 is used as a sealing element, or the portion shown by 5029 is used as a sealing element, the projection of the liquid inlet 5025 or 5027 of the lyophobic channel is still located within the horizontal projection of the sealing element, because the liquid inlet 5025 or 5027 is arranged at the recess, the liquid inlet cannot be sealed by the side wall of the connecting channel or the dewar, and the inner wall of the connecting channel is generally flat and smooth, so that the connecting channel is easy to seal, and the structure facilitates liquid removal.
In summary, when the sealing element seals the connection channel, it is preferable to let the sealing element into the connection channel, and to relieve the pressure of the sealing element, a lyophobic channel is required to be provided, and the liquid discharged from the sealing element into the connection channel is discharged to another place. As in the above-described embodiment, the liquid inlet of the lyophobic passage is provided below the sealing member, and the inlet of one end of the lyophobic passage is advanced into the connecting passage from the sealing member, so that the superfluous liquid can be introduced into the lyophobic passage. As also described above, when the receiving chamber is in the sealing member or is located at another position, the other outlet (liquid outlet) of the lyophobic channel communicates with the receiving chamber, thereby receiving the surplus liquid in the connecting channel.
In other alternatives, the first chamber may also be used as a receiving chamber, with the liquid sample removed by the sealing element in the connecting channel being discharged into the first chamber through the lyophobic channel. In the above embodiments, the inlet of the lyophobic channel is located on the sealing member or on the connection structure integrally formed with the cover body or below the sealing member. Of course, alternatively, the lyophobic channel may be located on the connecting channel instead of the sealing member, for example, the lyophobic channel may be located on a side wall of the connecting channel, the inlet (liquid inlet) of the lyophobic channel may be located on a side wall of the connecting channel, and the liquid outlet may be in communication with the first cavity, when the sealing member enters the connecting channel, the surplus liquid discharged due to the entering of the sealing member enters the first cavity through the liquid inlet of the lyophobic channel until the sealing member seals the inlet of the lyophobic channel. One of ordinary skill in the art will appreciate that, in view of the embodiments of the present invention, it is envisioned that regardless of the placement of the lyophobic channel, such as placement of the inlet and outlet ports, it is sufficient to exclude liquid sample from entering the connecting channel due to the sealing element, thereby reducing the resistance of the sealing element to the sealing element by liquid from the sealing element, such as by having the inlet port of the lyophobic channel located above the sealing element or elsewhere.
In other embodiments, the size of the inlet may be designed arbitrarily, e.g., liquid may enter, but liquid may not freely flow out of the inlet. Because the liquid enters the lyophobic channel through the liquid inlet, the liquid is often pressed by the liquid to enter the lyophobic channel, and after the liquid enters the lyophobic channel, the liquid cannot flow out of the liquid inlet due to the surface tension of the liquid inlet. This has the advantage that, because the inlet is generally located below the sealing element, and when the second chamber is open to the connecting channel, the inlet is exposed to the outside, which may also lead to a risk of contamination of the environment by the liquid sample if the liquid in the receiving chamber can flow out through the inlet, it is desirable that the inlet is only accessible for liquid but not for liquid. Typically, the inlet is sized, for example, 0.1-1-2 mm, so that liquid in the receiving chamber will not flow out of the inlet due to surface tension.
In some embodiments, the sealing element may be separated from the first cover after sealing the connection channel, if the sealing element is provided on the cover. In one embodiment, the sealing element is integral with or integral with the cover, the sealing element sealing the connection passage as the first cover closes the opening of the first cavity. When the sealing is completed, if the first cover body needs to be opened, the first cover body is reversely rotated to expose the opening of the first cavity, the sealing element still stays in the connecting channel to seal the connecting channel, and part of the liquid sample can be taken out of the first cavity for further detection or assay after the first cover body is removed. For example, as shown in fig. 33-35, the sealing element 5029 is removably coupled to the cap by a connecting rod 5023, at which time the sealing element 5029 is positioned on the element 5035. And the element 5035 is removably combined with the connecting rod 5023 of the cover in a manner other than the threaded configuration shown in fig. 33-35, but in a bayonet manner, i.e. with one end 5030 of the element 5035 inserted into one end of the connecting rod. After the first cover 502 has moved the sealing element 5029 to seal the connection channel, the second chamber can be separated from the first chamber, thereby sealing the opening of the second chamber, for example, by sealing the opening of the second chamber with the second cover, and using the sample in the second chamber as a second test. At this point, the first cap 502 has been closed over the first cavity, such as the opening 1031 of the first cavity 103 shown in FIG. 9, and if at this point it is desired to withdraw the liquid sample from the first cavity, the first cap is inverted, and at this point the seal member is in a relatively tight fit with the connecting channel, and the member 5035 is merely mated with the connecting rod, the first cap can again be separated from the first cavity 103 to allow the member 5035 to reside in the connecting channel. The advantage of this design is that if the first chamber is only used for collecting samples, after collecting samples, the connecting channel is sealed, and separation of the liquid samples is performed, the first cover can be opened at this time, part of the samples can be taken out of the first chamber as an assay, and if the assay results require further confirmation of detection, the second chamber can be removed from the first chamber for a second assay. In practice, multiple samples may be taken from the first chamber to perform multiple tests or assays of the unused index.
The above liquid to be removed is typically when both the connecting channel and the second chamber are filled with the liquid sample. It will be appreciated that when the second chamber is not filled with the liquid sample, the connecting channel will not normally contain the liquid sample, and if the sealing element enters the connecting channel to seal the connecting channel, the lyophobic channel can remove the compressed part of the gas outside the second chamber, and reduce the resistance of the sealing element entering the connecting channel, which is the reaction force generated by the compression of the gas to prevent the sealing element from entering.
In some preferred embodiments, therefore, the lyophobic channel acts to exclude liquid when the connecting channel is filled with liquid, and to better seal the connecting channel when the second chamber is not filled with liquid. Therefore, the lyophobic channel can play two functions or any one of the functions at the same time, so that the lyophobic channel can be called as a channel for discharging fluid, the fluid refers to liquid or gas or the mixture of the two, and correspondingly, the liquid inlet of the lyophobic channel can be called as an air inlet, the liquid outlet can be called as an air outlet or the inlet and the outlet of the lyophobic channel are collectively called as an inlet of the fluid. It will be appreciated that if venting of compressed gas is required, no special venting passages may be required, venting may be achieved by use of lyophobic passages, or such passages may be omitted, as the sealing element may be liquid tight to the extent that liquid seal is achieved, or indeed liquid tight only if gas is present. Therefore, when the gas removal is required, the gas removal function may be selected from small gaps between the sealing element and the connecting channel element, which may be errors between mechanical structures, or intentionally designed structures, which allow the gas to pass but not the liquid, so as to achieve the gas removal function. Of course, the vent channel or vent structure is not necessary here, as the sealing element seals the connecting channel with a liquid sealing effect, rather than with a gas sealing effect. In contrast, the air seal is not necessarily achieved when the liquid seal is achieved, but the effect of the liquid seal is achieved when the air seal is achieved.
The "lyophobic channel" is also a preferred mode of the invention because the sealing element better seals the connecting channel, allowing part of the sealing element to enter the connecting channel to better achieve the sealing effect. It is also possible that the sealing element only seals the first opening of the connection channel, and does not need to seal the opening but rather needs to be at a distance into one end of the connection channel, at which time the lyophobic channel may be default. If the second chamber is not filled with liquid, the lyophobic channel may be default, as the effect of sealing the opening or the connecting channel is not important, as there is no leakage of liquid. .
Also, in another case, a structure like a lyophobic passage may not be required, for example, as shown in the figure (design 2, when the opening of the connection passage is sealed with a cap, lyophobic passage is not required)
Liquid discharge element
In some preferred forms, the device of the present invention may further comprise a drainage element for draining a portion of the liquid sample in the second chamber. The term "liquid discharge element" as used herein refers to a liquid discharge element when an object enters a liquid sample, and since the object has a certain volume, the volume occupies a certain space of the liquid, thereby excluding a certain volume of the liquid, the volume of the object entering the liquid is the volume excluding the liquid, and the object entering the liquid may be referred to as a liquid discharge element. It is understood here that a ship-like ship is in water, and that a certain volume of water needs to be removed due to the weight of the ship, and that the ship occupies the space occupied by the original water. Of course, as mentioned above, if the space does not contain liquid but contains gas, the liquid discharge element is discharged from the space containing gas instead of liquid.
In other embodiments, for example, when the second chamber is filled with the liquid sample, the sealing member seals the connection channel, but the liquid in the second chamber is completely and substantially filled with the liquid sample, and when the second chamber needs to be detached from the first chamber, the liquid in the filled second chamber overflows due to mechanical operation, resulting in operation unfriendly and pollution to the outside or operators. In addition, even if the second chamber filled with the liquid sample is carefully removed or detached from the first chamber, it is not easy to seal the opening of the second chamber with the second cover, so that filling the second chamber with liquid may also pose some risk of leakage during transportation. Therefore, in a more preferred manner, it is desirable to exclude a portion of the liquid sample in the second chamber from the second chamber either simultaneously with or after or before the sealing element seals the connecting channel. Therefore, the liquid in the second cavity is not filled, and the liquid sample in the second cavity separated from the first cavity is not overflowed, so that the safety and the friendliness of operation are improved, the leakage risk in the subsequent secondary detection transportation process is reduced, and the friendliness and the safety of the subsequent secondary detection operation are also improved.
When the second chamber is removed from the device, such as shown in fig. 13, a certain space is reserved in the second chamber, so that the second chamber is not filled with liquid, and thus, when the second chamber is removed, the liquid sample cannot overflow from the second chamber, and the risk of polluting the outside is reduced.
In some preferred forms, the device further comprises a drainage element to drain the liquid sample from the second chamber out of the second chamber. It will be appreciated that the drainage element may be any structure or method for reducing the liquid sample in the second chamber. In some preferred forms, the drainage element is formed as an extension of the sealing element or the drainage element is located on the sealing element. For example, in fig. 2 to 3, the structures illustrated in fig. 18, 23, 27, 31, and 33 are shown. For example, in fig. 2-3, seal 1028 is of unitary construction with drain 1027, with drain 1017 and seal 1028 being substantially similar in shape, except that the longitudinal dimension is slightly larger than the seal and the lateral dimension is smaller than the seal. At this time, the horizontal projection of the liquid discharging element may be located within the horizontal projection of the sealing element or the horizontal projection of a part of the liquid discharging element may be located within the horizontal projection of the sealing element. At this time, when the sealing member enters the connection passage, first, the drain member 1027 enters the connection passage, since the diameter of the drain member 1027 is smaller than the diameter of the connection passage 109, all of the surplus liquid sample is discharged to the outside of the second chamber 104 or the first chamber 103 of the connection passage 109 through the space or slit 809 between the surface of the drain member and the surface of the connection passage 109, and at this time, the sealing member starts to seal the opening 1091 of the connection passage 109 as the drain member 1027 enters the second chamber (see fig. 22, 12), so that the sealing of the liquid-tight connection passage is performed as described above. Since the drain 1027 enters the second chamber, a portion of the liquid sample in the second chamber is removed. At this point, when the sealing member 1028 initially seals the opening 1091 of the connection channel, the liquid sample located below the opening 1091 of the connection channel cannot be removed through the space between the surface of the drain member 1027 and the surface of the connection channel 109, and at this point, if the sealing member is still required to move downward, the liquid sample that the drain member continues to remove and the liquid sample that the sealing member itself removes enter the lyophobic channel through the inlet of the lyophobic channel, and thus enter the receiving chamber. Therefore, in some preferred forms, the inlet of the lyophobic channel is located on the drain member. More preferably, the receiving cavity is located within the drainage element. It will be readily appreciated that the sealing element and the drainage element may be injection molded at one time. In the injection molding process, the injection molding is of a hollow structure, so that a containing cavity is formed to contain the discharged liquid.
As described above, in order to smoothly discharge the liquid to the outside through the inlet of the lyophobic passage, the lateral diameter of the liquid discharging member is smaller than the inner diameter of the connection passage. For example, the drainage element may be in the shape of an inverted cone, and a cone-like structure as in the drainage element of fig. 18, i.e. the inlet 3025 of the lyophobic channel. For example, the drain 3027 in fig. 27 has an inverted tapered structure. The tapered structure 4027 shown under the seal element 4029 shown in fig. 31 and 32, as the tapered structure formed by the drain structure 435 shown in fig. 33-35. In fact, the drainage structure does not need a separate structure, and if the sealing element is sufficiently long, it can penetrate into the second chamber, at which time it can perform the dual function of effecting a change in the state of fluid communication between the second chamber and the first chamber, while also excluding part of the fluid in the second chamber. Therefore, the drainage element is only functionally limited and does not require additional structure alone to achieve. In fact, these conical structures can also be used as drainage elements, as will be described in more detail later.
In other embodiments, such as those shown in fig. 15, 18, 22-23, and 27, the drain member 2027,3027 is coupled to the sealing member 2028,3028, also as an extension of the sealing member. Seal ring 208 is disposed outside seal member 2024 such that seal ring 208 is disposed on a surface of the seal member slightly above an outer surface of seal member 2014. Thus, even though the diameter of the drain element 2017 is the same as the diameter 2024 of the sealing element, when the drain element 2027 enters the connecting channel 209 (e.g., as in fig. 22), the sealing element and the drain element together enter the connecting channel, since the drain element is at the end and the sealing element is above the drain element, the drain element first enters the connecting channel, and if there is liquid in the connecting channel, the drain element enters the connecting channel and the drained liquid enters the first chamber 103 through the gap 809 between the surface of the drain element and the inner surface of the connecting channel. With further movement of the sealing element and the draining element, the draining element 2027 enters the first chamber, at which time the sealing ring may not have sealed the opening 2091 of the connecting channel 209, and with further movement of the draining element 2027 into the second chamber 204, liquid may still be expelled through the slit 809 into the first chamber 203. When the seal 2023 on the seal member 2024 seals the opening 2091 of the connecting passage 209, the liquid cannot be discharged into the first chamber through the slit 900. At this time, the sealing element and the sealing ring need to move continuously in the connecting channel, so as to achieve a stable sealing effect. Continued movement requires continued removal of the liquid sample, at which point excess liquid sample removed by the drain is removed through the inlet 2025 of the lyophobic channel to the outside of the connecting channel and the second chamber. For example, through the inlet 2025 of the lyophobic channel into the lyophobic channel and then through the outlet of the lyophobic channel into the housing chamber 2029 or into the first chamber. At this point, the second chamber 204 is separated from the device, such as shown in fig. 24 and 28, from the connecting channel, and a portion of the liquid sample in the second chamber is removed due to the presence of the drain 2027 in the second chamber. When the second chamber is removed from the device, as shown in fig. 28, for example, a certain space is reserved in the second chamber, so that the second chamber is not filled with liquid, and thus, when the second chamber is removed, a liquid sample cannot overflow from the second chamber, and the risk of polluting the outside is reduced.
It will be appreciated that the liquid draining element and the sealing element are the same size, and the liquid in the connecting channels can be discharged outside the two connecting channels or outside the second cavity through the liquid inlets of the lyophobic channels instead of being discharged from the gaps before the sealing element seals the connecting channels.
In other embodiments, the sealing element and the liquid discharge element are not significantly separated, for example, as shown in fig. 31-32, the sealing element 5028 is not provided with a sealing ring, the liquid discharge element 5027 and the sealing element 5028 are provided on an extension of the connecting structure 5023, one end of the connecting structure 5023 is connected with the first cover 502, and the other end is connected with the sealing element 5028 or is the end of the connecting structure. The sealing element 5028 is in turn connected to a drain element 5027. While the liquid inlet 5025 of the lyophobic channel is positioned on the tail end of the liquid discharging element, and the accommodating cavity is positioned in the liquid discharging element, the sealing element or the connecting structure. When the connecting structure, the sealing element and the liquid draining element are hollow structures, the liquid outlet of the lyophobic channel is communicated with the accommodating cavity. With reference to the description above, when such a drain 5027 enters the connecting channel, the drained liquid enters the lyophobic channel through the liquid inlet 5038 at the end of the drain and then enters the receiving chamber through the liquid outlet of the lyophobic channel. The liquid inlet can be provided with the size so as to enable liquid to pass through smoothly, but the liquid entering the accommodating cavity cannot leak out of the liquid inlet due to the surface tension of the liquid at the liquid inlet. This is because once the drain member enters the connection channels 109,209 through the opening 2091,1091 of the connection channel, the surface of the drain member 5027 is also sealed against the inner surface of the connection channel 209, and at this time, the drain member and the sealing structure are the same structure, the drain member serves both to seal the connection channel and to remove liquid. As the drain member moves within the connection channel, there is a pressure on the liquid within the connection channel that reacts to the drain member, thereby increasing the difficulty of the drain member 4027 entering the connection channel. In order to reduce the reaction force of the liquid, the excess liquid is let into the liquid inlet 4025 of the lyophobic channel, and thus into the receiving cavity 4029 in the liquid discharge resolution structure 4027.
When the second chamber is separated from the device, a portion of the liquid sample in the second chamber is removed because the drain 1027 is located in the second chamber. When the second chamber is removed from the device, such as shown in fig. 13, a certain space is reserved in the second chamber, so that the second chamber is not filled with liquid, and thus, when the second chamber is removed, the liquid sample cannot overflow from the second chamber, and the risk of polluting the outside is reduced. In addition, the liquid sample in the receiving chamber does not leak out through the liquid inlet 3025 due to the surface tension at the liquid inlet 3025.
In some embodiments, such as shown in fig. 33-35, the original 5035 may be used as a drain and the seal 5028 may be positioned on the connecting rod 5024, at which time the drain and seal are removably coupled, the overall lateral dimension of the drain 5035 is smaller than the dimension of the seal 5028, such as the diameter of the drain is smaller than the dimension of the seal 5028 (as shown in fig. 33), the connection of the drain and seal is threaded, such as the seal 5028 is hollow, with internal threads on the inner surface and the drain 5035 has an upwardly extending section 5030 with external threads on the extending section, such that the drain and seal 5028 are coupled by mating the internal and external threads. When the sealing element and the drain element are let into the connecting channel 209, the drain element is easy to enter into the connecting channel, since the drain element has a smaller size than the connecting channel, and excess liquid enters into the first chamber through the gap between the drain element and the connecting channel. With the sealing member sealing the opening 2091 of the connection channel 209, liquid cannot enter the first chamber through the slit, and with the sealing member entering the connection channel, excess liquid enters the receiving chamber or the first chamber through the liquid inlet 4025 of the lyophobic channel.
In some preferred forms, and referring again to fig. 33 and 35, the drain member 5035 is sized to correspond to the diameter of the sealing member 5028, or is sized to be smaller than the diameter of the sealing member, and the inlet 5025 of the lyophobic channel is disposed on the extension 5030. As can be seen in fig. 34, the diameter of the portion having the inlet 5025 is smaller than the diameter of the sealing member 5028 and smaller than the diameter of the drain member 5029, and a recessed region is formed at the inlet 5025. Thus, when the drain 5035 enters the connection channel 209, the liquid removed by the removal structure 5029 is removed through the liquid inlet 4025 of the lyophobic channel in the recess. As such, as the drain member is moved further into the connecting channel, to the space for the subsequent passage into the second chamber, the sealing member seals the opening 2091 of the connecting channel, and to the subsequent passage into the connecting channel, either or both of which liquid may be removed through the liquid inlet 5025 of the lyophobic channel, for example into the receiving chamber or the first chamber. It will be appreciated that the drainage element is also a preferred form herein and is not a necessary way of carrying out the invention.
Movement of sealing or draining elements
As previously stated, the sealing element seals the connection channel, and the drainage element also enters the connection channel or into the second chamber. These are all a moving process, and the movement of the sealing element and the draining element is initiated by a certain external force or by another mechanical structure. The sealing element and the draining element may thus be performed in a coordinated manner, e.g. the movement of the sealing element moves the draining element, and the movement of the sealing element moves, e.g. in the case of the draining element.
The term "linkage" as used herein refers to the movement of one object that directly or indirectly moves another object, and generally, the movement patterns of two objects are identical, such as a rotational movement of one object, and a rotational movement of the other object, such as an insertion movement of one object. For another example, an object is moved from an initial position to an end position, and during this movement, another substance is moved from the initial position to the end position. The rotation movement may be a movement from an initial position to an end position, of course rotation and insertion may be mixed or used separately. Motion and movement are meant to be understood interchangeably herein.
The first cover body and the sealing element or the liquid discharging element move in a linkage mode, namely, the movement of the first cover body drives the movement of the sealing element, so that the liquid discharging element is driven to move. Or the first cover body and the liquid discharging element move in a linkage mode, namely, the movement of the first cover body drives the liquid discharging element to move, so that the sealing element is driven to move. In some preferred modes, the sealing element is located on the first cover body, and when the cover body covers the opening of the first cavity, the cover body drives the sealing element to seal the connecting channel, so that a sealing state is formed. As described above, the sealing of the connecting channel by the sealing element is generally divided into three states, the first state being that the sealing element does not contact the opening of the connecting channel. For example, as shown in fig. 22, the first cover 202 has a sealing element 2028 thereon, and when the cover is closed over the opening 2031 of the first cavity 203, the sealing element 2028 is driven into the first cavity, and the sealing element does not contact the first opening 2091 (fig. 22) of the connection channel, and the connection channel connects the first cavity and the second cavity, and simultaneously, the first cavity and the second cavity are in fluid communication through the channel. As the cap is closed over the opening 2031 of the first cavity, the cap moves from top to bottom along the longitudinal axis of the first cavity, bringing the sealing element gradually closer to the opening 2091 of the connection channel. At this time, as the first cover is further closed, the sealing member 2028 contacts the first opening 2091 of the connection passage 209, thereby sealing the opening (fig. 23). At this point it may be considered that the connecting channel 209 is sealed. However, to ensure a more stable sealing of the connection channel, it is desirable that the sealing element enters the connection channel 209 a distance so as to more stably seal the connection channel, at which time the closure of the cover is still required so as to push the sealing element 2028 into the connection channel. A similar process is shown, for example, in fig. 12-27. Regardless of the type or form of sealing element, it is a preferred manner for these sealing elements and the cover to move simultaneously. Of course, the movement of the cover and the movement of the sealing element may also be separate movements, e.g. the first cover is used to cover the opening of the first cavity, thereby completing the covering process. The sealing element, instead of being additionally moved alone to seal the connection channel, is not done in cooperation with the first cover.
As for the liquid discharge element, the function is to discharge part of the liquid in the second chamber, and as described above, the liquid discharge element is required to discharge the liquid when the second chamber is filled with the liquid, but if the second chamber is not filled with the liquid, the liquid discharge element may not be required at this time. Therefore, the drainage element is a preferred, not necessary, way of the present invention. When the liquid draining element is needed, the liquid draining element and the cover body can be connected into an integral structure, so that the movement of the cover body drives the liquid draining element to move, and the liquid draining element is inserted into the second cavity for draining liquid. Of course, as previously mentioned, the sealing element and the draining element are two distinct elements, and the draining element enters the second chamber before the sealing element. In a preferred manner, the drainage element enters the connection channel before the sealing element, and thus into the second chamber. For such a design, the drain element is located at the end of the sealing element, further away from the first cover, so that such a functional design is achieved.
In some preferred forms of the invention, therefore, the invention provides a cover on which is provided a sealing element for sealing the connection channel. In some preferred embodiments, a sealing ring is provided on the sealing element. In some preferred embodiments, the material of the sealing element and the connecting channel are the same or different. In some preferred forms, the sealing member is a flexible material and the connecting channel is a rigid material. In some preferred forms, the sealing element is integrally formed with the first cover by a connecting rod. In some preferred forms, the sealing element further comprises an opening for a lyophobic channel. In some preferred embodiments, the opening of the lyophobic channel is located below the sealing element, or the opening of the lyophobic channel enters the connecting channel before the sealing element. In some preferred forms, the cover further includes a receiving cavity thereon in fluid communication with the lyophobic channel. The containing cavity is communicated with the liquid outlet of the lyophobic channel. In some preferred forms, the receiving cavity is located in the sealing element.
In other preferred embodiments, a drainage element is also provided on the first cover, which drainage element is further away from the first cover than the sealing element. The drain element is either arranged below the sealing element or the sealing element and the drain are arranged such that the drain element enters the second chamber before the sealing element or the drain element enters the connecting channel before the sealing element. Or when the cover body is provided with a connecting rod to connect the first cover body and the sealing element, and the sealing element is connected with the liquid draining element. Or the connecting rod, the sealing element and the liquid draining element are integrated.
In another way, if the first and second chambers are not initially in fluid communication, but are required to be in fluid communication after the first chamber has collected a liquid sample, the cover may be provided with a first element that places the first and second chambers in fluid communication and a second element that places the first and second chambers out of fluid communication. For example, the first chamber and the second chamber are not initially realized in a fluid communication state in that the first opening 1091 of the connection channel is sealed at the beginning when the sealing element is present, and if the first element and the second element are coupled together, the first element is first brought into contact with the sealing element, for example, when the sealing element is in a structure that is easy to puncture, the first element is in a sharp puncture structure, and after puncturing, the fluid in the first chamber enters the second chamber. Subsequently, the second element is allowed to reseal the first opening, thereby effecting a change in the fluid flow state. Thus, the second chamber can be separated from the first chamber. It will be appreciated by the skilled person that the second element may be any of the alternatives to the sealing elements described above, may also comprise a drainage element, may also be a lyophobic channel arrangement, etc. Such as in the previous embodiments shown in fig. 37-40.
First cover and second cover
The first cover is here a cover for covering the first cavity, while the second cover is an opening for covering the second cavity. A specific example of the cover may be the shape of the cover as shown in fig. 1 to 28. Of course, the cover performs the function of covering the opening of the first cavity, and the first cover is not necessarily required to seal the opening of the first cavity. But the primary function of the second cover is to seal the opening of the second chamber from leakage of the liquid sample. Thus, in some embodiments, the second cover is positioned over the first cover, and the second cover is removably combined with the first cover. For example, the second covers may be screwed or otherwise plugged together and removed from the first cover to seal the second cavity when it is desired to seal, typically liquid-tightly, the opening of the second cavity.
Method for detecting or collecting liquid sample
The invention also provides a method for collecting a liquid sample, which comprises the step of providing the device for collecting the liquid sample, wherein the device comprises a first cavity and a second cavity, the second cavity and the first cavity are detachably connected, the liquid sample is collected by the first cavity, and the liquid sample flows into the second cavity. In some preferred forms, the second chamber is separated from the first chamber when the second chamber collects a liquid sample, such that the opening of the second chamber is covered with a second cover. In some preferred forms, the first chamber is not in fluid communication with the second chamber prior to separating the first chamber from the chambers. In some preferred forms, the sealing element isolates the first and second chambers such that the first and second chambers are not in flow communication.
In some preferred forms, the first and second chambers are connected together by a connecting channel, wherein the first opening of the connecting channel is in fluid communication with the first chamber and the second opening of the connecting channel is in fluid communication with the second chamber. The second chamber is separated from the first chamber by separating the second chamber from the connecting channel, or the second chamber is detachably connected to the connecting channel without the connecting channel being detachably connected to the first chamber, or the second chamber is detachably connected to the connecting channel and the connecting channel is detachably connected to the first chamber.
In some aspects, the sealing element is configured to seal the connection channel when the second chamber is removably coupled to the first chamber via the connection channel. Thus, in some preferred forms, the device further comprises a sealing element that seals the connection channel before the second chamber is separated from the first chamber. In some preferred forms, the device further comprises a cover, the cover and the sealing element being integrally formed such that when the cover is closed over the first cavity opening, the cover simultaneously moves the sealing element to seal the first opening of the connecting channel. In some preferred embodiments, the cover is arranged to carry the sealing element into the connecting channel. In some preferred forms, the second chamber is separated from the first chamber after the sealing member seals the connection passage. In some preferred modes, a liquid draining element for draining part of the liquid in the second cavity is further arranged on the cover body, so that the cover body drives the liquid draining element to enter the second cavity. In some preferred forms, the cover is provided with a sealing element and a drainage element, the drainage element being advanced into the second chamber before the sealing element. In some preferred embodiments, the device further comprises a lyophobic channel, and the liquid sample discharged from the liquid discharging element is discharged out of the second cavity through the lyophobic channel. In some preferred embodiments, the sealing element is allowed to enter the connection channel, and the liquid discharged from the sealing element is discharged to the outside of the connection channel through the lyophobic channel. In some preferred forms, the liquid removed by the sealing element or the drainage element is drained through the lyophobic channel into the first chamber. In some preferred forms, a receiving chamber is provided in the cover, said receiving chamber being in fluid communication with the lyophobic channel, wherein fluid removed by the sealing element and/or the draining element is drained into the receiving chamber through the lyophobic channel.
In some embodiments, the lyophobic channel has a liquid inlet and a liquid outlet, and liquid removed by the sealing element and/or the liquid draining element enters the liquid inlet and then enters the accommodating cavity through the liquid outlet of the lyophobic channel.
In other embodiments, the cover is provided with a sealing element that when the opening of the first cavity is closed by the cover, the sealing element is driven to seal the connecting channel. In some aspects, if the first cover is again moved away from the opening of the first cavity, the sealing element remains in the connecting channel, which is separated from the cover.
In another aspect, the present invention provides a method for detecting the presence of an analyte in a liquid sample, the method comprising the step of using a test element to detect the presence of the analyte in the liquid sample after the liquid sample has been collected in the first chamber by the liquid collection device according to any of the above aspects. And after the detection result is obtained, separating the second cavity from the first cavity, and performing separation according to any mode. In some embodiments, the device further comprises a detection chamber for receiving the test element, the detection chamber being in flow communication with the first chamber, the liquid flowing into the detection chamber after the first chamber has collected the liquid sample. When the test element is included in the test chamber, the second chamber is separated from the first chamber after the test element completes the test. In some preferred forms, the liquid sample is allowed to pass from within the first chamber into the detection chamber and then into the second chamber. Such a configuration is designed as described above to avoid that liquid entering the detection chamber also enters the second chamber, thereby contaminating the liquid sample in the second chamber.
Detection cavity
The detection chamber is used in the present invention to perform an analytical test on a liquid sample from the first chamber for the presence of an analyte. The detection chamber may be devoid of detection means and typically includes a test element in the detection chamber that is in contact with the liquid sample to perform an assay or test on the liquid sample. In conventional products, it is common to manufacture devices with test chambers by first forming the test element or having the test element disposed on a carrier, then inserting the test element into the test chamber, and then sealing the test chamber. In this case, the detection chamber generally has an opening to allow access of the test element into the detection chamber. For example, as shown in fig. 1 and 9, the detection chamber 105 has an opening 1051 near the opening 1031 of the first chamber 103, and a test element (not shown) placed on the test carrier 106 is positioned in the card slot 1061 of the test carrier, and then the carrier 106 is inserted into the detection chamber through the opening of the detection chamber. In general, after the device is inserted into the detection chamber, the opening 1051 of the detection chamber needs to be sealed, which has very high sealing effect and quality requirement, and as described above, the whole detection device or the collection device needs to be transported and packaged together, so that in order to avoid leakage of the liquid in the detection chamber or the liquid in the first chamber, any place where leakage may occur needs to be strictly sealed, and each product needs to be detected in a sealing manner, thus increasing production cost. However, with the second chamber of the present invention having a secondary confirmation, these previous considerations may not be taken into account where a good seal is required, which only requires a temporary seal and does not require a permanent seal. For example, as shown in fig. 9, the opening 1051 for the inspection may be sealed by a conventional seal, such as a film, so long as the film seal is airtight or leak-free during the inspection, and after the second chamber is separated from the first chamber after the inspection, the first chamber and the inspection chamber may be disposed of without storing or transporting the entire inspection apparatus.
Example 1
How the detection device of the present invention is assembled and operated will now be described with reference to specific examples of embodiments.
For example, as shown in fig. 1-3, and 6-14, the device includes a first chamber 103 and a second chamber 104, an opening 1031 in the first chamber 103 for introducing a liquid sample. As shown in fig. 1, the first chamber is defined by a side wall and a bottom, and a raised area is provided at the bottom of the first chamber, for example, as shown in fig. 9, the raised area is located at the center of the entire bottom, and an opening 1091 is provided in the raised area, and a section of connection channel 109 is provided, where the connection channel 109 has a first opening 1091 communicating with the interior of the first chamber 103 and another opening 1092 communicating with an opening 1042 of the second chamber. A recess is formed around the raised area inside the first chamber, which recess forms a liquid sample collection area 1035,1036 (see fig. 7). A screw thread structure 1101 is provided on the opposite wall of the connecting channel 109 near the outside of the second opening 1092 and a screw thread structure 1041 is provided on the outer wall of the opening 1042 of the second chamber 104, which screw thread forms a rotational fit with the screw thread 1101 on the wall 110, thereby allowing the second chamber 104 to form a detachable fit with the first chamber through the connecting channel 109. Also included is a detection chamber 105 in fluid communication with the first chamber through a through bore 1038. A test element is included in the detection chamber. The test elements are disposed in the card slots 1061 of the test carrier 106. Typically, the sample application area of the test element is located in the area of the test carrier near the bottom of the second chamber, or near the bottom 1051 of the detection chamber, while the bibulous area of the test element is near the other end of the detection chamber (near the end of the first chamber opening 1031).
A cover 102 is also provided, a connecting rod 1023 is connected to the center of the cover, a sealing element 1028 is provided at the end of the connecting rod, and a sealing ring 108 is provided on the sealing element. Meanwhile, a drain member 1027 is provided under the sealing member, and the drain member 1027, the sealing member and the connecting rod 1023 are integrally formed, only the division of the unused functional area. Typically, the length of the connecting rod 1023 and sealing element 1038 and drain element 1027 is slightly greater than the distance from the opening 1031 of the first chamber 103 to the opening 1042 of the second chamber 104, so that the drain element 1027 can be allowed to enter the second chamber 104 to drain a portion of the liquid sample from the second chamber. Meanwhile, a liquid inlet 1025 (fig. 2 and 3) of a lyophobic channel is provided below the sealing member 1028. The fluid inlet 1025 may be located between the fluid discharge member 1027 and the sealing member 1028. Meanwhile, the sealing element, the liquid draining element and the connecting rod are hollow structures, and the inside of the sealing element, the liquid draining element and the connecting rod comprises a containing cavity 1029 for collecting redundant liquid samples. When in use, the opening of the first cavity is firstly used for collecting the liquid sample, the liquid sample is collected at the bottom of the first cavity along with the entering of the liquid sample, then enters the detection cavity through the through hole 1038, and the liquid sample entering the detection cavity is contacted with the sample reagent area of the test element, so that the assay and the detection are performed. As the liquid increases, the liquid sample enters the second chamber through the opening 1091 of the connection channel, and then the liquid sample gradually fills the second chamber 104, and then floods the first opening 1091 of the connection channel, and finally the liquid level is higher than the first opening 1091 of the connection channel 109. This is when collection of the liquid sample is stopped. Subsequently, the first cover 102 is closed to the opening 1031 of the first chamber 103. As the cover body covers the opening 1031, the cover body rotates to cover, so as to drive the sealing element 1028, the drain element 1027 and the liquid inlet 1025 of the lyophobic channel to approach the opening of the connection channel 109 (fig. 10, 11 and 12). As the cover rotates, the drain 1027 first enters the connection channel 109, where the sealing ring of the sealing element is not yet adjacent to the first opening 1091 of the connection channel. Liquid may enter the first chamber 103 through the gap between the drain member 1027 and the connection channel 109. Along with the sealing element entering the connecting channel 109, the liquid discharged at this time enters the accommodating cavity 1029 through the liquid inlet 1025 of the lyophobic channel, so that the redundant liquid sample is discharged, the pressure of the sealing element entering the connecting channel is relieved, and better sealing is easier to obtain. After the drainage element has entered the second chamber, the sealing element also seals the connection channel 109. In this case, the test element of the test chamber is first tested, and after the remaining sample is deemed necessary to be retained for a second confirmatory test, the second chamber is separated from the first chamber by rotating the second chamber, and the sealing element seals the connecting channel, so that the liquid sample in the first chamber cannot leak out. The opening 1042 of the second chamber 104 is then sealed with the second cover 101 disposed over the first cover 102 (as shown in fig. 14 and 13). The second cover can be stored or packaged separately and transported to an assay facility for a secondary confirmatory assay.
Example 2
For example, as shown in fig. 15-18, and fig. 23-28, the device is shown to include a first cavity 203 and a second cavity 204, with an opening 2031 in the first cavity 203 for introducing a liquid sample. As shown in fig. 16, the first chamber is defined by a sidewall and a bottom, and a raised area is provided at the bottom of the first chamber, such as in fig. 24, the raised area being centrally located throughout the bottom, and an opening 2091 is provided in the raised area, and a connecting channel 209 is provided, the connecting channel 209 having a first opening 2091 communicating with the interior of the first chamber 203 and another opening 2092 communicating with the opening 2042 of the second chamber. A groove is formed around the raised area inside the first chamber, which forms a liquid sample collection area 2035,2034 (see fig. 24). A thread formation 2101 is provided on the opposite wall of the connecting channel 209 near the outside of the second opening 2092 and a thread formation 2043 is provided on the outer wall of the opening 2042 of the second chamber 204, which thread forms a rotational fit with the thread 2101 on the wall 210, thereby allowing the second chamber 204 to form a detachable fit with the first chamber through the connecting channel 209. At the same time, a carrier 206 is provided having a plurality of channels sealed at one end 2062 and open at the other end 2063, one or more test strips being disposed in the channels, a sample application area of the test strips being located at one end of the opening 2063, one or more channels for receiving the test strips being disposed in the carrier 206, one test element being disposed in each channel, and when there are a plurality of channels, a different test element for an analyte being disposed in each channel, such that a plurality of analytes can be detected using the same sample. Such a carrier 206 is placed in the first cavity 203 with two stop bars 2032 and 2033 on the walls of the cavity 203, and the carrier 206 is inserted or snapped into the two stop slots with the open channel end 2065 near the bottom of the first cavity and the sealed channel end 2064 near the first cavity opening 2031 (FIG. 16). When the liquid sample flows into the first chamber through the opening 2031 of the first chamber, the liquid sample contacts the sample application area of the test strip, thereby completing the test.
A cover 202 is also provided, to the centre of which is connected a connecting rod 2023, the end of which is provided with a sealing element 2028 on which a sealing ring 208 is provided. Meanwhile, a drain element 2027 is provided under the sealing element, and the drain element 2027, the sealing element 2028, and the connecting rod 2023 are integrally formed, just the division of the unused functional area. Typically, the length of the connecting rod 2023 and sealing element 2028 and the drain element 2027 is slightly greater than the distance from the opening 2031 of the first chamber 203 to the opening 2042 of the second chamber 204, so that the drain element 2027 may be allowed to enter the second chamber 204, thereby removing a portion of the liquid sample in the second chamber. Meanwhile, a liquid inlet 2025 (fig. 18 and 26) of a lyophobic passage is provided below the sealing member 2028. The liquid inlet 2025 may be located between the liquid discharge element 2027 and the sealing element 2028.
Meanwhile, the sealing element, the liquid draining element and the connecting rod are hollow structures, and the inside of the sealing element, the liquid draining element and the connecting rod comprises a containing cavity 2029 for collecting redundant liquid samples. When in use, the opening of the first cavity is firstly used for collecting the liquid sample, and the liquid sample is collected at the bottom of the first cavity along with the entering of the liquid sample, and then is contacted with the application area of the test element on the carrier for testing and detecting. As the liquid increases, the liquid sample enters the second chamber through the opening 2091 of the connecting channel, and then the liquid sample gradually fills the second chamber 204, then floods the first opening 2091 of the connecting channel, and eventually the liquid level is higher than the first opening 2091 of the connecting channel 209. Then, as the liquid is added, the liquid sample is stopped from being received when the set position is reached. Subsequently, the first cover 202 is closed to the opening 2031 of the first cavity 203. As the cover closes the opening 2031, the cover rotates to close, driving the sealing element 2028, the drain element 2027, and the liquid inlet 2025 of the lyophobic channel to approach the opening of the connection channel 209 (as shown in fig. 22). As the cap is rotated, the drain 2027 first enters the connecting channel 209, at which time the sealing ring of the sealing element is not yet adjacent to the first opening 2091 of the connecting channel, and does not seal the first opening 2091 of the connecting channel. Liquid may enter the first chamber 203 through a gap 809 between the drain 2027 and the connecting channel 209. Along with the sealing of the connecting channel in the connecting channel 209, the liquid discharged by the sealing element or the liquid discharging element enters the accommodating cavity 2029 through the liquid inlet 2025 of the lyophobic channel, so that the redundant liquid sample is discharged, and the pressure of the sealing element entering the connecting channel is reduced, so that better sealing is easier to obtain. After the drainage element has entered the second chamber, the sealing element also seals the connection channel 209. At this time, the test element of the test chamber has been subjected to a first or primary test, and it is considered necessary to hold the remaining sample for a secondary confirmatory assay, and then the second chamber is separated from the first chamber by rotating the second chamber, and the liquid sample in the first chamber is not leaked out because the connecting channel is sealed by the sealing element. The opening 2042 of the second chamber 204 is then sealed with the second cover 201 disposed over the first cover 202 (see fig. 24). This allows the second chamber to be individually stored or packaged for transport to an assay facility for a secondary confirmatory assay.
Example 3
For example, as shown in fig. 25-30, the device includes a first chamber 303 and a second chamber 304, an opening 3031 in the first chamber 303 for introducing a liquid sample. As shown in fig. 27, the first cavity is defined by a side wall and a bottom, and a raised area is provided at the bottom of the first cavity, for example, as shown in fig. 27, the raised area is located at the center of the entire bottom, an opening 3091 is provided at the raised area, a section of connecting channel 309 is provided, the first opening 3091 communicates with the interior of the first cavity 303, and the other opening 3092 communicates with the opening 3042 of the second cavity. A groove is formed around the raised area inside the first chamber, which forms a liquid sample collection area 3035,3036 (fig. 27). The connecting channel 309 is smooth outer and inner walls adjacent to the second opening 3092. There is a tray structure 1004 having internal threads 10041 that threadably mate with external threads at the bottom of the first cavity.
The second cavity 304 is located on a base tray 1004, and the base tray 1004 is removably coupled to the first cavity, and the second cavity 304 is also removably coupled to the base tray 1004. In particular, the tray structure 1004 has internal threads that mate with external threads 3031 extending from the bottom of the first cavity 303 to enable removable combination of the tray structure 1004 with the first cavity 303. Thus, if there is also a connecting channel, as shown in FIG. 27, the connecting channel 309 may still have a first opening 3091 in fluid flow with the first cavity and a second opening 3092 in fluid flow with the second cavity, and the connecting channel may have an extension 3098 that extends into the opening 3052 of the second cavity, contacts the inner wall of the opening 3041, and may snap together, i.e., the outer diameter of the extension area matches the inner diameter of the opening 3041. Although the second chamber and the first chamber may also be snap-connected via the connection channel 109 as in fig. 27, this connection does not require a very strong connection and does not require as tight a connection as in fig. 8-9 (by means of threads, etc.), since the tray structure 1004 is engaged by the threads 10041 with the external threads 3031 of the extension of the first chamber 103, which does not cause leakage problems between the connection channel 109 and the second chamber opening 1042, no matter how much liquid sample is collected by the second chamber 304. Therefore, the inner diameter of the connection channel 109 may be smaller than the inner diameter of the opening 1042 of the second chamber, which allows the connection channel to be inserted into the opening 3042 of the second chamber in a manner that allows easy insertion (shown in FIG. 27). But only the outer edge of the opening 3042 is provided with threads for the closure of the second cover (see fig. 27). At this time, the connection of the connection channel and the opening of the second chamber is sufficient to ensure that no leakage occurs when collecting the liquid sample, i.e. to allow the liquid to enter the second chamber, without further structural restrictions. The connection can be in the forms of clamping connection, piston type connection and locking connection. In practice, having the first chamber detachably combined, joined or joined with the second chamber is accomplished in an indirect manner.
After the collection is completed, the sealing of the connection channel or/and the draining of the second chamber is performed according to the method described later, and if a second confirmation test is required, the tray structure 1004 is separated from the first chamber 103, for example, by reversely screwing the tray to match the threaded structure of the bottom of the first chamber, at this time, the second chamber 104 located on the tray is also separated from the first chamber 103 together with the tray structure, as shown in fig. 27, at this time, the second cover 101 is removed to cover the opening 3042 of the second chamber, and then the second chamber is separated from the tray 1004 (as shown in fig. 29), because the bottom of the second chamber has the snap-fit structure 10042 with the bottom of the tray, so that the tray and the second chamber are separated from the first chamber 103 together. The tray 1004 is then detached from the second cavity 304 and the tray 1004 is then separately attached to the first cavity 103 and assembled. At this point, the integrity of the first chamber is maintained, while the second chamber may be sent to a confirmatory assay mechanism for a secondary confirmatory assay. In order to allow the second cavity 304 to disengage from the first cavity as the tray moves, a snap ring 10042 is provided on the tray, which snap ring is shaped to accommodate the cavity shape of the second cavity 304, e.g. the cavity of the second cavity is U-shaped, and the snap ring 10042 is also U-shaped, such that the tray structure 1004, when rotated, brings the second cavity 304 to rotate together, and the second cavity 304 and the tray structure 1004 together disengage from the first cavity 303 as the second cavity and the snap ring may mate slightly tightly. Of course, in some modes, the second cavity is of a cube-like structure, 4 buckle structures are arranged on the tray, and the second cavity and the buckle structures are clamped together, so that the movement of the tray drives the movement of the second cavity, and the separation of the second cavity and the first cavity is realized.
The cover 302 is further provided, a connecting rod 3023 is connected to the center of the cover, a sealing element 3028 is arranged at the tail end of the connecting rod, a sealing ring is arranged on the sealing element, and the sealing ring and the sealing element are made of the same material and are formed by one-step injection molding. Meanwhile, a drain member 3027 is provided under the sealing member, and the drain member 3027, the sealing member, and the connection rod 3023 are integrally formed, only the division of the unused functional area. Typically, the length of the connecting rod 3023 and the sealing member 3038 and the drain member 3027 is slightly greater than the distance from the opening 3031 of the first chamber 303 to the opening 3042 of the second chamber 304 so that the drain member 3027 can be allowed to enter the second chamber 304 to thereby drain a portion of the liquid sample from the second chamber. Meanwhile, a liquid inlet 3025 (fig. 27) of a lyophobic passage is provided below the sealing member 3028. The inlet 3025 may be located between the drain member 3027 and the sealing member 3028 or on the drain member. Meanwhile, the sealing element, the liquid draining element and the connecting rod are hollow structures, and the inside of the sealing element, the liquid draining element and the connecting rod comprises a containing cavity 3029 for collecting redundant liquid samples. When in use, the opening of the first cavity is firstly used for collecting the liquid sample, and the liquid sample is collected at the bottom of the first cavity along with the entering of the liquid sample. As the liquid increases, the liquid sample enters the second chamber through the opening 1091 of the connection channel, and then the liquid sample gradually fills the second chamber 304, and then floods the first opening 3091 of the connection channel, and finally the liquid level is higher than the first opening 3091 of the connection channel 309. This is when collection of the liquid sample is stopped. Subsequently, the first cover 302 is closed over the opening 3031 of the first cavity 303. As the cover closes the opening 3031, the cover rotates to close, driving the sealing member 3028, the drain member 3027 and the liquid inlet 3025 of the lyophobic channel to be close to the opening of the connection channel 309. As the cap is rotated, the drain 3027 first enters the connection passage 309, at which time the sealing ring of the sealing member is not yet adjacent to the first opening 3091 of the connection passage. Liquid may enter the first chamber 303 through the gap between the drain 3027 and the connection channel 309. With the sealing element entering the connecting channel 309, the liquid removed at this time enters the receiving cavity 3029 through the liquid inlet 3025 of the lyophobic channel, thereby removing the excess liquid sample, and also reducing the pressure of the sealing element entering the connecting channel, so that a better seal is easier to obtain. After the drainage member has entered the second chamber, the sealing member also seals the connecting channel 309.
In this case, the liquid in the first chamber may be used for subsequent primary detection, and after the remaining sample is deemed necessary to be retained for secondary confirmation assay, the tray structure is separated from the first chamber by rotating the tray structure, so as to drive the separation of the second chamber from the first chamber, and the second chamber is separated from the first chamber. The opening 3042 of the second cavity 304 is then sealed with the second cover 301 disposed over the first cover 302 (see fig. 28). At this point the tray structure and the second chamber can be packaged together and sent to the assay mechanism for a second assay. Or the second chamber may be removed from the tray and packaged for use as a secondary confirmation assay (fig. 29). At this point the tray is again continued onto the first cavity, forming the finished structure (fig. 30).
The following is also part of the present invention.
A device for receiving a liquid sample includes a first chamber for collecting a liquid sample and a second chamber for collecting a confirmation test liquid sample, wherein the first chamber and the second chamber are removably coupled, combined or connected.
The device wherein the first chamber and the second chamber are in fluid communication.
The device wherein the first chamber and the second chamber are in fluid communication when the second chamber is not exiting the first chamber.
The device wherein the first chamber and the second chamber are not in a liquid flow state until the second chamber exits the first chamber or immediately before the second chamber exits the first chamber.
The device is characterized in that, in the device, the first cavity and the second cavity are detachably assembled together.
The device is characterized in that the second cavity is positioned below the first cavity, or when liquid is collected, the liquid firstly enters the first cavity and then enters the second cavity, or the second cavity is positioned downstream of the first cavity, or when liquid is collected, the liquid simultaneously enters the first cavity and the second cavity, or part of the liquid sample enters the first cavity, and the other part of the liquid sample enters the second cavity.
The device wherein the fluid communication state between the first chamber and the second chamber comprises one or more of a fluid communication state and a fluid non-communication state.
The device comprises a first cavity, a second cavity, a third cavity and a third cavity, wherein the first cavity and the second cavity are in a liquid non-circulation state, then in a liquid circulation state, and finally in a liquid non-circulation state.
The device is characterized in that the first cavity and the second cavity are in a liquid circulation state and then in a liquid non-circulation state.
The device, wherein the first and second chambers are removably combined when the first and second chambers are in fluid communication, or the first and second chambers may be separated or already separated when the first and second chambers are in fluid communication.
The device wherein the first and second chambers are removably coupled together when the first and second chambers are in a liquid-tight condition.
The device further comprises a sealing element, wherein the sealing element can change the liquid circulation state between the first cavity and the second cavity, or the device further comprises a puncture element, wherein the puncture element can change the state of being in a liquid non-circulation state into the liquid flow state, or the device further comprises a sealing element and a puncture element, and the puncture element enables the first cavity and the second cavity to be in the liquid circulation state firstly, and then enables the liquid to be in the non-circulation state through the sealing element.
The device wherein the sealing element leaves the first chamber and the second chamber in fluid communication prior to the second chamber exiting the first chamber, or prior to or immediately prior to the second chamber being separated from the first chamber.
The device also comprises a connecting channel, the second cavity is detachably combined, combined or assembled with the first cavity through the connecting channel, or/and the second cavity and the first cavity are in liquid communication or not in a liquid communication state through the connecting channel.
The device further comprises a connecting channel, and the second cavity is in liquid communication with the first cavity through the connecting channel.
The device wherein the connecting channel is not sealed when the second chamber is not leaving the first chamber, or the connecting channel is sealed before or after the second chamber is leaving the first chamber.
The device wherein the connecting channel is sealed by a sealing element.
The device further comprises a sealing element for sealing the passage such that no fluid communication exists between the first chamber and the second chamber.
The device also comprises a lyophobic channel, wherein the lyophobic channel is provided with a liquid inlet.
The device is characterized in that the liquid inlet is arranged below the sealing element, or when the sealing element seals the channel, the liquid inlet is close to the connecting channel before the sealing element, or when the sealing element enters the connecting channel, the liquid inlet is arranged below the horizontal position of the sealing element, or when the sealing element enters the connecting channel, the liquid inlet enters the connecting channel before the sealing element.
The device, wherein, the inlet is located on sealing element.
The device is characterized in that the liquid inlet is positioned on the side wall of the connecting channel.
The device is characterized in that the lyophobic channel is also provided with a liquid outlet, and the liquid outlet is in liquid communication with a containing cavity.
The device, wherein the receiving cavity is located on the sealing element.
The device, wherein, lyophobic passageway still have the liquid outlet, liquid outlet and first chamber fluid intercommunication.
The device further comprises a liquid draining element for draining a portion of the liquid sample in the second chamber.
The device wherein the drainage element is located in the second chamber or partially in the second chamber prior to separation of the second chamber from the first chamber.
The device, wherein after the second cavity and the first cavity are separated, the second cavity does not contain liquid draining elements or does not contain partial liquid draining elements.
The device further comprises a liquid draining element for draining part of the liquid sample in the second cavity, wherein the liquid draining element is positioned on the sealing element or is connected with the sealing element into a whole.
The device is characterized in that the liquid draining element enters the connecting channel before the sealing element, or enters the second cavity before the sealing element, or is positioned in the second cavity when the sealing element is positioned in the connecting channel.
The device also comprises a lyophobic channel, wherein the lyophobic channel is provided with a liquid inlet, and the liquid inlet is positioned on the liquid draining element, or the device comprises a containing cavity, and the containing cavity is positioned on the liquid draining element.
The device is characterized in that the liquid inlet is in liquid communication with a containing cavity, and the containing cavity is positioned in the liquid draining element.
The device is characterized in that a partial region of the sealing element is used as a liquid discharge element for discharging liquid in the second cavity.
The device, wherein the partial sealing element is used for sealing the connecting channel, and the partial sealing element is used for removing partial liquid in the second cavity.
The device, wherein the partial sealing element is used for sealing the connecting channel, and the partial sealing element is positioned in the second cavity.
The device, wherein the vertical projection area of the liquid discharge element is positioned in the vertical projection area of the sealing element.
The device further comprises a lyophobic channel, the lyophobic channel is provided with a liquid inlet, and the vertical projection of the liquid inlet is positioned in the vertical projection area of the sealing element.
The device further comprises first and second sealing elements, wherein the first or second sealing element is capable of changing the fluid communication between the first and second chambers.
The device, wherein the first sealing element is used for sealing the connecting channel, the second sealing element is used for sealing the opening of the second cavity, or the first sealing element is used for sealing the opening of the second cavity, and the second sealing element is used for sealing the first opening of the connecting channel.
The device is characterized in that the position of the second cavity is changed from the first position to the second position while or after the opening of the second cavity is sealed by the first sealing element, or the second cavity is separated from the second cavity.
The device, wherein the sealing element or the liquid draining element is moved in a linkage way.
The device, wherein, the linkage is used for covering the first cavity opening cover body and moving.
The device, wherein the motion is a rotational motion.
A method of collecting a liquid sample, the method comprising:
There is provided a collection device comprising a first chamber for collecting a liquid sample and a second chamber for collecting a liquid sample, wherein the first and second chambers are removably combined, joined or assembled, and wherein the first and second chambers are placed in fluid communication prior to collecting the liquid sample so as to allow liquid entering the first chamber to flow into the second chamber.
The method includes leaving the first chamber and the second chamber out of fluid communication after the first chamber collects the fluid sample.
The method wherein the second chamber is separated from the first chamber or the first chamber is separated from the second chamber when the first chamber and the second chamber are not in fluid communication.
The method wherein the liquid sample entering the second chamber is allowed to originate from the liquid sample in the first chamber, the liquid is allowed to enter both the first and second chambers, or a portion of the liquid sample is allowed to enter the first chamber and another portion of the liquid sample is allowed to enter the second chamber.
The method comprises the steps of connecting the first cavity and the second cavity through a connecting channel, wherein the second cavity is detachably combined, combined or assembled with the connecting channel, or enabling the first cavity and the second cavity to be in a liquid circulation state through the connecting channel.
The method is carried out by sealing the channel with a sealing element, leaving the first and second chambers in fluid communication.
The method includes the steps of providing a passageway having a first opening in fluid communication with the first chamber and a second opening in fluid communication with the second chamber, and sealing the first opening of the connecting passageway with a sealing element.
The method wherein after the sealing element seals the first opening of the connecting channel, a portion of the sealing element is allowed to enter the channel.
The method further comprises a lyophobic channel in the device, wherein the lyophobic channel comprises a liquid inlet.
The method wherein, when a portion of the sealing element is allowed to enter the channel, the liquid sample removed by the sealing element is removed from the connecting channel or from the second chamber through the liquid inlet, if the liquid sample is present.
The method wherein the liquid sample removed by the sealing element is removed into the receiving cavity through the lyophobic channel.
The method further comprises a lyophobic channel in the device, wherein the lyophobic channel comprises a liquid inlet, and the liquid inlet enters the connecting channel before the sealing element.
The method further comprises a drain element in the device for draining part of the liquid in the second chamber.
The method, when the sealing element is provided, allows the liquid draining element to enter or approach the connecting channel before the sealing element.
The method wherein the drainage element is allowed to enter the second chamber or a portion of the drainage element is allowed to enter the second chamber.
The method wherein the drainage element is not located in the second chamber after the second chamber is separated from the first chamber.
The method comprises the steps of allowing the liquid draining element to enter the second cavity when the sealing element seals the first opening of the connecting channel, or allowing the sealing element to enter the connecting channel and allowing the liquid draining element to enter the second cavity.
The method allows the sealing element and the liquid draining element to move in a linkage way.
The linkage is performed by a cover body covering the first cavity.
A device for receiving a liquid sample includes a first chamber for collecting a liquid sample and a second chamber for collecting a sample for confirmation of detection of the liquid sample, wherein the first chamber has an opening for receiving the liquid sample and the second chamber has an opening for receiving the liquid sample from the first chamber.
The device further comprises a tray structure, wherein the second cavity is detachably arranged on the tray structure, and the tray structure is detachably combined with the first cavity.
The device wherein the second chamber and the second chamber are in fluid communication when the tray structure is assembled with the first chamber.
The device comprises a first cavity and a second cavity, wherein the first cavity comprises a hole which is in liquid communication with the opening of the second cavity, or a liquid sample in the first cavity can flow into the second cavity under the action of gravity of the liquid.
The device is characterized in that the hole is a first opening of the connecting channel, the second cavity is in fluid communication with the first cavity through the connecting channel, or the hole is provided with an extending channel, and the second cavity is in fluid communication with the first cavity through the extending channel.
The device wherein the connecting channel or the extending channel has a first opening in fluid communication with the first lumen and a second opening in fluid communication with the second lumen.
The device further comprises a sealing element for sealing the connecting channel, the extending channel or the hole.
The device wherein the sealing element may be sealed by sealing a first opening of the connecting channel or the extending channel or a portion of the sealing element into the connecting channel or the extending channel.
The device further comprises a lyophobic channel.
The device comprises a lyophobic channel, wherein the lyophobic channel comprises a liquid inlet, the liquid inlet is positioned below a sealing element, or when the sealing element seals a connecting channel or an extending channel, the liquid inlet is positioned close to the connecting channel or the extending channel before the sealing element, or when the sealing element enters the connecting channel or the extending channel, the liquid inlet is positioned below the horizontal position of the sealing element, or when the sealing element enters the connecting channel, the liquid inlet enters the connecting channel before the sealing element.
The device also comprises a lyophobic channel, wherein the lyophobic channel comprises a liquid inlet, and a projection area of the liquid inlet is positioned in the projection area of the sealing element.
The device, wherein, the inlet is located on sealing element.
The device is characterized in that the liquid inlet is positioned on the side wall of the connecting channel.
The device, wherein the liquid inlet is lower than the position of the connecting channel opening
The device is characterized in that the lyophobic channel is also provided with a liquid outlet, and the liquid outlet is in liquid communication with a containing cavity.
The device, wherein the receiving cavity is located on the sealing element.
The device, wherein the lyophobic channel is also provided with a liquid outlet which is in fluid communication with the first cavity
The device further comprises a lyophobic channel, wherein the lyophobic channel comprises a liquid inlet, and part of liquid forced by the sealing element enters the lyophobic channel through the liquid inlet so as to be discharged out of the channel and or the second cavity.
The device comprises a liquid draining element for draining part of the liquid sample in the second cavity.
The device also comprises a lyophobic channel, wherein the lyophobic channel comprises a liquid inlet, and the liquid inlet is positioned on the liquid draining element.
The device, wherein the liquid discharging element and the sealing element are connected into a whole structure, and when the sealing element is arranged.
The device wherein the drainage element enters the second chamber before the sealing element when the channel is sealed with the sealing element.
The device is characterized in that the lyophobic channel comprises a liquid outlet, and the liquid outlet is in liquid communication with a containing cavity.
The device, wherein when the part of the sealing element enters the connecting channel, the accommodating cavity is used for receiving the liquid sample discharged by the sealing element entering the connecting channel.
The device, wherein the accommodating cavity is positioned in the sealing element or the liquid draining element.
The device, wherein the projection area of the liquid draining element is located within the vertical projection area of the sealing element.
The device wherein the drain member has a transverse diameter smaller than the transverse diameter of the sealing member.
The device wherein the connecting channel is cylindrical and the sealing element is also cylindrical.
The device further comprises a first cover body for covering the opening of the first cavity.
The device is characterized in that the cover body and the sealing element move in a linkage way, and the cover body and the liquid discharging element move in a linkage way, or the cover body and the sealing element and the liquid discharging element move in a linkage way.
The device, wherein when the first cover body is covered with the first cavity opening, the sealing element seals the first opening of the connecting channel or part of the element enters the connecting channel along with the cover body.
The device further comprises a liquid draining element, and the liquid draining element is connected with the sealing element.
The device is characterized in that the liquid draining element is far away from the first cover body than the sealing element.
The device is characterized in that the sealing element is connected with the first cover body through a connecting rod.
The device, wherein, sealing element and connecting rod detachably connect.
The device also comprises a lyophobic channel, wherein the lyophobic channel comprises a liquid inlet, and a projection area of the liquid inlet is positioned in the projection area of the sealing element.
The device is characterized in that the liquid inlet is far away from the first cover body than the sealing element.
The device is characterized in that the liquid inlet is positioned on the liquid discharge element.
The device wherein the drainage element or a portion of the drainage element is positioned in the second chamber when the sealing element seals the connection channel.
A method of collecting a liquid, the method comprising:
There is provided a device for collecting a liquid sample, wherein the device comprises a first chamber for collecting a liquid sample, wherein the first chamber has an opening for receiving the liquid sample, and
A second chamber for collecting a sample of the validation test fluid, the second chamber having an opening for receiving the sample of the fluid from the first chamber;
A tray structure comprising a second cavity, wherein the tray structure is removably combined, combined or combined with the first cavity;
The first chamber is used to collect a liquid sample and the liquid sample is allowed to pass through the opening of the first chamber into a chamber.
The method wherein the first chamber has an aperture, the aperture being in fluid communication with the second chamber.
The method wherein the first chamber and the second chamber are brought into fluid communication through the aperture prior to fluid collection.
The method wherein liquid is allowed to enter the first chamber and then flows automatically from the first chamber into the second chamber through the aperture when liquid is being collected, or liquid is allowed to enter both the first chamber and the second chamber, or a portion of liquid is allowed to enter the first chamber and another portion of liquid is allowed to enter the second chamber.
The method wherein the bore has an extended extension channel, the portion of the extension channel is located in the second chamber, or the opening of the portion of the second chamber is located in the portion of the channel, thereby establishing fluid communication.
The method wherein a sealing element seals the aperture or the extension channel after the collection of the liquid sample is completed, thereby enabling the second chamber to be out of fluid communication with the first chamber.
The method includes allowing the tray to leave the first cavity when the second cavity is not in fluid communication with the first cavity, thereby driving the second cavity to leave the first cavity.
The method wherein the second cavity is disengaged from the tray.
The method wherein the second cavity is separated from the former and latter of the tray and the opening of the second cavity is covered with a second cover, thereby forming a sealed second cavity.
The method comprises the steps of providing a first cover body for covering the opening of the first cavity, and arranging the sealing element on the cover body to enable the cover body and the sealing element to carry out linkage movement.
The method wherein the cover body moves the sealing element to form a fluid-tight relationship between the first chamber and the second chamber during closing of the opening of the first chamber.
The method wherein the cover carries a sealing element to seal the aperture or extension passage between the first and second chambers.
In the method, the cover body drives the sealing element, so that part of the sealing element enters the extension channel.
The method further comprises a liquid draining element, wherein the liquid draining element is far away from the cover body than the sealing element.
The method further comprises a lyophobic channel in the cover body, wherein the lyophobic channel comprises a liquid inlet, the liquid inlet is far away from the cover body than the sealing element, or the liquid inlet enters the extension channel before the sealing element.
The method comprises the step of arranging a projection area of the liquid inlet in a projection area of the sealing element.
The method wherein a portion of the liquid forced by the sealing element enters the lyophobic channel through the liquid inlet and is thereby expelled out of the channel and/or the second cavity.
The method comprises the steps that the lyophobic channel comprises a liquid outlet, and the liquid outlet is in liquid communication with a containing cavity.
The method comprises the step of arranging the accommodating cavity in the sealing element, the liquid draining element or the cover body.
The method includes the step of receiving the liquid sample discharged from the connecting channel when the sealing element enters the connecting channel.
The method wherein when the drainage element enters the second chamber, the portion of the drainage element that is removed also enters the receiving chamber.
A test device for detecting an analyte in a sample includes a first chamber for collecting a liquid sample and a second chamber for collecting a sample for confirming detection of the liquid sample, wherein the first chamber has an opening for receiving the liquid sample and the second chamber has an opening for receiving the liquid sample from the first chamber, wherein the device further includes a test element.
The device further comprises a tray structure detachably connected with the first cavity, wherein the second cavity is arranged on the tray, and the second cavity is detachably combined, combined or connected with the first cavity through the tray.
The device, wherein the second cavity realizes the fluid communication state with the first cavity through a channel.
The device wherein the passageway has a first opening in fluid communication with the first chamber and a second opening in fluid communication with the second chamber.
The device further comprises a sealing element for sealing the connecting channel.
The device, wherein the sealing element sealing the connection channel may be sealed by a first opening of the sealing channel or a part of the sealing element entering the connection channel.
The device also comprises a lyophobic channel, wherein the lyophobic channel comprises a liquid inlet and a liquid outlet, and the liquid inlet is positioned in a region below the sealing element.
The device also comprises a lyophobic channel, wherein the lyophobic channel comprises a liquid inlet and a liquid outlet, and a projection area of the liquid inlet is positioned in a projection area of the sealing element.
The device further comprises a liquid draining element for draining part of the liquid in the second cavity, and the liquid draining element and the sealing element are connected together.
The device also comprises a lyophobic channel, wherein the lyophobic channel comprises a liquid inlet, and the liquid inlet is positioned on the liquid draining element.
The device comprises a liquid-repellent channel, wherein the liquid-repellent channel comprises a liquid outlet, the liquid outlet is in liquid communication with a containing cavity, and the containing cavity is used for structuring liquid discharged by a liquid-discharging element.
The device, wherein when the part of the sealing element enters the channel, the accommodating cavity is used for receiving the liquid sample discharged by the sealing element entering the connecting channel.
The device, wherein the accommodating cavity is positioned in the sealing element or the liquid draining element.
The device, wherein the projection area of the liquid draining element is located within the vertical projection area of the sealing element.
The device wherein the drain member has a transverse diameter smaller than the transverse diameter of the sealing member.
The device wherein the connecting channel is cylindrical and the sealing element is also cylindrical.
The device further comprises a first cover body for covering the first cavity opening, wherein the sealing element is arranged on the cover body, so that when the first cover body covers the first cavity opening, the sealing element seals the first opening of the connecting channel or part of the sealing element enters the connecting channel along with the cover body.
The device further comprises a liquid draining element, and the liquid draining element is connected with the sealing element.
The device is characterized in that the liquid draining element is far away from the first cover body than the sealing element.
The device is characterized in that the sealing element is connected with the first cover body through a connecting rod.
The device, wherein, sealing element and connecting rod detachably connect.
The device also comprises a lyophobic channel, wherein the lyophobic channel comprises a liquid inlet, and a projection area of the liquid inlet is positioned in the projection area of the sealing element.
The device is characterized in that the liquid inlet is far away from the first cover body than the sealing element.
The device is characterized in that the liquid inlet is positioned on the liquid discharge element.
The device wherein the drainage element or a portion of the drainage element is positioned in the second chamber when the sealing element seals the passageway.
The device further comprises a detection chamber in fluid communication with the first chamber, wherein the test element is located in the detection chamber.
The device further comprises a carrier comprising a plurality of channels for receiving the test elements, wherein the carrier is positioned in the first chamber.
The device wherein the sample application area of the test element is located at the bottom of the first chamber.
A chamber for collecting a liquid sample, said chamber comprising:
A sidewall;
The bottom has an aperture for allowing the liquid sample entering the chamber to flow out of the chamber.
The bottom of the cavity is provided with a convex area in the cavity, and the convex area and the side wall form a liquid sample collecting area.
The sample collection area is configured to receive a test carrier.
The test carrier comprises a test element.
The raised area includes the aperture therein.
The bore has an extended passage.
The channel extends into the cavity and/or extends out of the cavity.
The channel extends outside the cavity.
The raised area has a platform structure in the cavity, the platform structure including the aperture.
The cavity also comprises an extension area at the bottom, and the length of the extension area exceeds or is equal to the length of the extension channel.
The position of the hole is higher than the position of the bottom of the collecting area, or when liquid is collected, the liquid firstly flows into the collecting area and then flows into the hole.
A cap comprising a sealing element.
The cover body is used for covering the opening of the cavity.
The cover body also comprises a connecting rod structure, one end of the connecting rod is connected with the cover body, and the other end of the connecting rod is connected with the sealing element.
The sealing element is the tail end of part of the connecting rod, or the sealing element and the connecting rod are in an integrated structure.
The sealing element is made of elastic materials.
The sealing element is detachably connected with the connecting rod.
The sealing element is connected with the connecting rod in a threaded and fastening way.
The sealing element and the connecting rod are hollow structures.
The sealing element and the connecting element are formed by one-time injection molding.
The sealing element comprises a sealing ring.
The sealing ring and the sealing element are made of the same material, or the sealing element containing the sealing ring is formed by one-time injection molding.
A cover includes a sealing member and a liquid discharge member.
The cover body is used for covering the opening of the cavity.
The cover body also comprises a connecting rod structure, one end of the connecting rod is connected with the cover body, and the other end of the connecting rod is connected with the sealing element and the liquid draining element.
The sealing element is the tail end of part of the connecting rod, or the sealing element and the connecting rod are in an integrated structure.
The sealing element is made of elastic materials.
The sealing element is connected with the liquid draining element.
The liquid draining element is far away from the body of the cover body than the sealing element.
The vertical projection of the liquid discharge element is positioned in or overlapped with the vertical projection area of the sealing element.
The lateral diameter of the liquid draining element is smaller than that of the sealing element.
The liquid discharging element has a cone shape.
One of the sealing element, the connecting rod and the liquid draining element comprises a hollow cavity, or the sealing element, the connecting rod and the liquid draining element are hollow structures.
A cover body comprises a sealing element, a liquid draining element and a containing cavity.
The cover body also comprises a connecting rod structure, one end of the connecting rod is connected with the cover body, and the other end of the connecting rod is connected with the sealing element and the liquid draining element.
The sealing element is the tail end of part of the connecting rod, or the sealing element and the connecting rod are in an integrated structure.
The sealing element is made of elastic materials.
The sealing element is connected with the liquid draining element.
The liquid draining element is far away from the body of the cover body than the sealing element.
One of the sealing element, the connecting rod and the liquid draining element comprises a hollow cavity or a multi-position hollow structure of the sealing element, the connecting rod and the liquid draining element, and the accommodating cavity is a part of the hollow cavity or the hollow structure.
The lateral diameter of the liquid draining element is smaller than that of the sealing element.
The liquid discharging element has a cone shape.
The accommodating cavity is positioned in the connecting rod, the sealing element or the liquid draining element.
The cover body comprises a sealing element and a lyophobic channel, wherein the lyophobic channel comprises a liquid inlet and a liquid outlet.
The cover body also comprises a connecting rod structure, one end of the connecting rod is connected with the cover body, and the other end of the connecting rod is connected with the sealing element.
The liquid inlet of the lyophobic channel is far away from the body of the cover body than the sealing element.
The sealing element is connected with the liquid draining element.
The liquid inlet of the lyophobic channel is positioned on the liquid discharge element.
The sealing element comprises a sealing ring, and the liquid inlet of the lyophobic channel is far away from the body of the cover body than the sealing ring.
The cover body also comprises a containing cavity, wherein the liquid outlet of the lyophobic channel is in fluid communication with the containing cavity.
One of the sealing element, the connecting rod and the liquid draining element comprises a hollow cavity or a multi-position hollow structure of the sealing element, the connecting rod and the liquid draining element, and a liquid outlet of the lyophobic channel is in fluid communication with the hollow cavity or the hollow structure.
The liquid outlet of the lyophobic channel is far away from the body of the cover body than the sealing element.
The vertical projection of the liquid discharge element is in or overlapped with the vertical projection area of the sealing element.
A device for collecting a liquid sample comprising a first chamber and a second chamber, wherein a region protruding into the chamber is provided at the bottom of the chamber, the protruding region forming a space protruding relative to the first chamber, thereby forming a space recessed relative to the bottom, and the portion of the second chamber being located within the recessed region.
The first cavity comprises a hole, and the hole and the opening of the second cavity form a liquid circulation state.
The device also comprises a connecting channel, and the second cavity is detachably combined, combined or assembled with the connecting channel.
The opening of the second cavity comprises external threads, the connecting channel comprises internal threads, and the external threads of the second cavity and the internal threads of the connecting channel are combined, combined or assembled through threads.
The hole is provided with an extension channel, the extension section is a part of the connecting channel, and the extension channel is positioned in the concave space.
The partially extended passage is located in the second chamber.
The outer diameter of the partial extension channel is equal to or smaller than the inner diameter of the second cavity opening.
The extension channel is inserted into the second cavity.
The device further comprises a connecting channel, the hole is a first opening of the connecting channel, the first opening is in fluid communication with the first cavity, and the second cavity is in fluid communication with a second opening of the connecting channel.
The device also comprises a tray structure, wherein the second cavity is detachably arranged on the tray structure, and the tray structure is detachably combined with the first cavity.
A chamber for collecting a fluid sample, said chamber comprising:
A sidewall;
The device comprises a cavity, a bottom and an opening for receiving liquid, wherein the bottom is provided with an opening for allowing liquid sample entering the cavity to flow out of the cavity, and the device further comprises a detection cavity for placing a test element, and the detection cavity and the cavity are in liquid communication through a through hole.
The position of the opening is higher than that of the through hole, or the opening is closer to the opening of the cavity than the through hole, or the through hole is closer to the bottom of the cavity than the opening.
When the cavity collects the liquid sample, the liquid first enters the through hole and then enters the opening, or part of the liquid sample enters the through hole and part of the liquid sample enters the opening.
The opening includes a channel extending outwardly from the bottom.
The bottom of the cavity is provided with a convex area in the cavity, and the convex area and the side wall form a liquid sample collecting area.
The collecting area comprises a bottom, and the opening is higher than the bottom of the collecting area.
The bottom of the collecting area is the bottom area of a part of the cavity.
The detection cavity comprises a test element.
The test element is located on a carrier which is located in the detection chamber.
The test element includes a sample application region for contacting a liquid sample in a test volume.
A device for collecting a liquid sample, the device comprising a first chamber for collecting a liquid sample and a second chamber, said second chamber further comprising a detection chamber in fluid communication with the second chamber for initial detection, wherein the bottom of the first chamber has an opening, said opening being sealed by a sealing element.
The first cavity and the second cavity are detachably combined, combined or assembled.
The sealing element is a penetrable sealing element.
One or more of a plastic film, a double-sided adhesive tape, a single-sided adhesive tape and an aluminum foil of the sealing element.
The opening has an outwardly extending passage including a second opening in fluid communication with the second chamber.
The device further comprises a puncturing element for puncturing the sealing element and/or a further sealing element.
The device further comprises a further sealing element for sealing the opening after the piercing element pierces the sealing element.
The piercing element and the further sealing element are arranged on a first cover body for covering the opening of the first cavity.
The piercing element is remote from the body of the cap relative to the other sealing element.
The piercing element and the further sealing element are arranged such that the piercing element pierces the sealing element sealing the opening, and then releases part of the liquid into the second chamber, and then the further sealing element seals the opening.
The device further comprises a second cover for sealing the second opening of the channel.
All patents and publications mentioned in the specification are indicative of those of ordinary skill in the art to which this invention pertains and which may be applied. All patents and publications cited herein are hereby incorporated by reference to the same extent as if each individual publication were specifically and individually indicated to be incorporated by reference. The invention described herein may be practiced in the absence of any element or elements, limitation or limitations, not specifically disclosed herein. For example, the terms "comprising," "consisting essentially of," and "consisting of," in each example herein, may be replaced with the remaining 2 terms of one of the two. The term "a" or "an" as used herein means "one" only, and does not exclude that only one is included, and may also mean that more than 2 are included. The terms and expressions which have been employed herein are used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described, but it is recognized that various modifications are possible within the scope of the invention and of the claims. It is to be understood that the embodiments described herein are illustrative of the preferred embodiments and features and that modifications and variations may be made by those skilled in the art in light of the teachings of this invention and are to be considered as falling within the scope of the invention and the appended claims.

Claims (43)

1. A device for collecting a liquid sample includes a first chamber for collecting a liquid sample and performing a test, and
Wherein the first chamber and the second chamber are removably coupled, combined or connected, the device further comprising a test chamber in fluid communication with the first chamber, the test element being located in the test chamber;
the bottom of the first cavity is provided with a convex area, the convex area is positioned in the center of the whole bottom, an opening is arranged in the convex area, and a section of connecting channel is arranged, wherein the first opening of the connecting channel is communicated with the opening of the second cavity, and the other opening of the connecting channel is communicated with the first opening of the first cavity;
An elongated space is arranged on the outer wall of the second opening of the connecting channel, and the elongated space can just cooperate with the opening of the second cavity to realize the combination of the first cavity and the second cavity;
the sealing device comprises a first cover body, a connecting channel and a connecting rod, wherein the first cover body is used for covering the first cavity opening, and a sealing element is arranged on the cover body, so that when the first cover body covers the first cavity opening, the sealing element seals the first opening of the connecting channel along with the cover of the cover body;
the device also comprises a liquid draining element for draining part of liquid in the second cavity, wherein the liquid draining element is connected with the sealing element;
The liquid-repellent channel comprises a liquid inlet and a liquid outlet, and the liquid inlet is positioned in a region below the sealing element;
the position of the first opening of the connecting channel is higher than the height of the through hole, and the position of the collecting area is lower than the position of the first opening of the connecting channel;
the tray structure is detachably connected with the first cavity, wherein the second cavity is arranged on the tray and is detachably combined, combined or connected with the first cavity through the tray.
2. The device of claim 1, wherein the first and second chambers are in fluid communication.
3. The device of claim 1, wherein the first chamber and the second chamber are in fluid communication when the second chamber does not leave the first chamber.
4. The device of claim 1, wherein the first and second chambers are not in a liquid flow state before the second chamber exits the first chamber or just before the second chamber exits the first chamber.
5. The device of claim 1, wherein the second chamber is located below the first chamber or downstream of the first chamber.
6. The device of claim 1, wherein liquid enters the first chamber before the second chamber when liquid is collected, or wherein liquid enters both the first chamber and the second chamber when liquid is collected, or wherein a portion of the liquid sample enters the first chamber and another portion of the liquid sample enters the second chamber.
7. The device of claim 1, wherein the fluid communication state between the first and second chambers comprises one or more of a fluid communication state and a fluid non-communication state.
8. The device of claim 1, wherein the first and second chambers are in a liquid-impermeable state, then in a liquid-permeable state, and finally in a liquid-impermeable state.
9. The device of claim 1, wherein the first and second chambers are in a liquid-flow state prior to being in a liquid-non-flow state.
10. The device of any of claims 1-8, wherein the first and second chambers are removably coupled together when the first and second chambers are in fluid communication, or wherein the first and second chambers are separable or have been separated when the first and second chambers are in fluid communication.
11. The device of claim 10, wherein the first and second chambers are removably coupled together when the first and second chambers are in a liquid-tight condition.
12. The device of claim 11, further comprising a lancing element that is capable of changing from a fluid-impermeable state to a fluid-flowable state, or further comprising a sealing element and a lancing element that first places the lancing element in fluid communication with the first chamber and the second chamber and then places the fluid in non-communication with the sealing element.
13. The device of claim 12, wherein the sealing element leaves the first chamber and the second chamber in fluid communication before the second chamber leaves the first chamber.
14. The device of claim 13, wherein the connecting channel is not sealed when the second lumen does not exit the first lumen, or is sealed after the second lumen exits the first lumen.
15. The device of claim 14, wherein the fluid inlet is located on a side wall of the connecting channel.
16. The device of claim 15, wherein the lyophobic channel further has a liquid outlet, the liquid outlet being in fluid communication with a receiving chamber.
17. The device of claim 16, wherein the receiving chamber is located on the sealing member.
18. The device of claim 17, wherein the drainage element is located in or partially in the second chamber prior to separation of the second chamber from the first chamber.
19. The device of claim 18, wherein the second chamber is free of or partially free of drainage elements after separation of the second chamber from the first chamber.
20. The device of claim 19, wherein the drainage member enters the connection channel before the sealing member, or the drainage member enters the second chamber before the sealing member, or the drainage member is positioned in the second chamber when the sealing member is positioned in the connection channel.
21. The device of claim 20, wherein the liquid inlet is located on the liquid discharge member, or the device comprises a receiving chamber located on the liquid discharge member.
22. The device of claim 21, wherein a portion of the sealing member is used as a drainage member for draining liquid from the second chamber.
23. The device of claim 22, wherein a portion of the sealing element is configured to seal the connecting channel and a portion of the sealing element is configured to remove a portion of the liquid from the second chamber.
24. The device of claim 23, wherein the partial sealing member is configured to seal the connection channel and the partial sealing member is positioned in the second chamber.
25. The device of claim 24 wherein the vertical projection of the drainage element is located within the vertical projection of the sealing element.
26. The device of claim 25, wherein the vertical projection of the inlet is located within the vertical projection area of the sealing element.
27. The device of claim 26, wherein the sealing element or drainage element is moved in tandem.
28. The device of claim 27, wherein the linkage is used to move the cover over the first cavity opening.
29. Apparatus according to claim 27 or 28, wherein said movement is a rotational movement.
30. A method of collecting a liquid sample, the method comprising:
providing a device according to any one of claims 1 to 29, comprising a first chamber for collecting a liquid sample and a second chamber for collecting a liquid sample, wherein the first and second chambers are detachably combined, joined or assembled;
placing the first chamber and the second chamber in fluid communication prior to collecting the liquid sample, thereby allowing liquid entering the first chamber to flow into the second chamber;
when the first cavity collects the liquid sample, the first cavity and the second cavity are not in a liquid circulation state;
Separating the second chamber from the first chamber or allowing the first chamber to separate from the second chamber when the first chamber and the second chamber are not in fluid communication;
When part of the sealing element enters the channel, the liquid sample discharged by the sealing element is discharged outside the connecting channel or outside the second cavity through the lyophobic channel;
the liquid draining element is arranged before the sealing element and enters or approaches to the connecting channel, and partial liquid in the second cavity is drained by the liquid draining element.
31. The method of claim 30, wherein the liquid sample entering the second chamber is allowed to originate from the liquid sample in the first chamber, the liquid is allowed to enter both the first chamber and the second chamber, or a portion of the liquid sample is allowed to enter the first chamber and another portion of the liquid sample is allowed to enter the second chamber.
32. The method of claim 31, wherein the first and second chambers are connected by a connecting channel, wherein the second chamber is removably combined, joined or assembled with the connecting channel, or wherein the first and second chambers are placed in fluid communication through the connecting channel.
33. The method of claim 32, wherein the passageway has a first opening in fluid communication with the first chamber and a second opening in fluid communication with the second chamber, and wherein the sealing member seals the first opening of the connecting passageway.
34. The method of claim 33, wherein after having the sealing element seal the first opening of the connecting channel, having a portion of the sealing element enter the channel.
35. The method of any of claims 30-34, wherein the lyophobic channel includes a liquid inlet.
36. The method of claim 35, wherein the liquid sample removed by the sealing element is removed from the connecting channel or from the second chamber through the liquid inlet when a portion of the sealing element is allowed to enter the channel, if the liquid sample is present.
37. The method of claim 36, wherein the liquid sample removed by the sealing element is removed through the lyophobic channel into the receiving cavity.
38. The method of claim 37, wherein the lyophobic channel includes a liquid inlet that enters the connecting channel prior to the sealing member.
39. The method of claim 38, wherein the drainage element is allowed to enter the second chamber or a portion of the drainage element is allowed to enter the second chamber.
40. The method of claim 39, wherein the drainage element is not positioned in the second chamber after the second chamber is separated from the first chamber.
41. The method of claim 40, wherein the fluid discharge element is allowed to enter the second chamber while the sealing element seals the first opening of the connecting channel, or the sealing element is allowed to enter the connecting channel and the fluid discharge element is allowed to enter the second chamber.
42. The method of claim 41, wherein the sealing member and the drainage member are moved in tandem.
43. The method of claim 42, wherein the interlocking is performed by a cover that covers the first cavity.
CN201810714500.XA 2018-02-13 2018-06-29 A device for collecting liquid samples Active CN110161265B (en)

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US16/044,283 US10830672B2 (en) 2018-02-13 2018-07-24 Apparatus for collecting liquid sample
MX2020008505A MX2020008505A (en) 2018-02-13 2018-07-25 An apparatus for collecting liquid sample.
PCT/CN2018/096954 WO2019157796A1 (en) 2018-02-13 2018-07-25 An apparatus for collecting liquid sample
EP18906159.1A EP3752841B1 (en) 2018-02-13 2018-07-25 An apparatus for collecting liquid sample
US16/967,957 US12360019B2 (en) 2018-02-13 2018-07-25 Apparatus for collecting liquid sample

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CN2018101504850 2018-02-13

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CN201821040943.7U Expired - Fee Related CN209656722U (en) 2018-02-13 2018-06-29 A device for collecting liquid samples
CN201821043213.2U Expired - Fee Related CN209559910U (en) 2018-02-13 2018-06-29 a cover
CN201821040955.XU Expired - Fee Related CN209148707U (en) 2018-02-13 2018-06-29 A cavity for collecting liquid samples
CN201810714500.XA Active CN110161265B (en) 2018-02-13 2018-06-29 A device for collecting liquid samples
CN201821040926.3U Expired - Fee Related CN208721694U (en) 2018-02-13 2018-06-29 A device for collecting liquid samples
CN201821042015.4U Expired - Fee Related CN209014585U (en) 2018-02-13 2018-06-29 A cavity for collecting liquid samples
CN201821043073.9U Expired - Fee Related CN209014586U (en) 2018-02-13 2018-06-29 a cover
CN201821040995.4U Expired - Fee Related CN209014584U (en) 2018-02-13 2018-06-29 A detection device for detecting an analyte in a sample
CN201810717088.7A Active CN110161267B (en) 2018-02-13 2018-06-29 A detection device for detecting an analyte in a sample
CN201821040979.5U Expired - Fee Related CN209656723U (en) 2018-02-13 2018-06-29 A device for collecting liquid samples
CN201810715825.XA Active CN110161266B (en) 2018-02-13 2018-06-29 Method for collecting liquid sample
CN201810714355.5A Active CN110161264B (en) 2018-02-13 2018-06-29 Device for collecting liquid sample
CN201810717252.4A Active CN110161268B (en) 2018-02-13 2018-06-29 A device for collecting liquid samples
CN201821043190.5U Expired - Fee Related CN208953548U (en) 2018-02-13 2018-06-29 A kind of lid
CN201821042076.0U Expired - Fee Related CN209559909U (en) 2018-02-13 2018-06-29 A device for collecting liquid samples
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CN201821043073.9U Expired - Fee Related CN209014586U (en) 2018-02-13 2018-06-29 a cover
CN201821040995.4U Expired - Fee Related CN209014584U (en) 2018-02-13 2018-06-29 A detection device for detecting an analyte in a sample
CN201810717088.7A Active CN110161267B (en) 2018-02-13 2018-06-29 A detection device for detecting an analyte in a sample
CN201821040979.5U Expired - Fee Related CN209656723U (en) 2018-02-13 2018-06-29 A device for collecting liquid samples
CN201810715825.XA Active CN110161266B (en) 2018-02-13 2018-06-29 Method for collecting liquid sample
CN201810714355.5A Active CN110161264B (en) 2018-02-13 2018-06-29 Device for collecting liquid sample
CN201810717252.4A Active CN110161268B (en) 2018-02-13 2018-06-29 A device for collecting liquid samples
CN201821043190.5U Expired - Fee Related CN208953548U (en) 2018-02-13 2018-06-29 A kind of lid
CN201821042076.0U Expired - Fee Related CN209559909U (en) 2018-02-13 2018-06-29 A device for collecting liquid samples
CN201821043187.3U Expired - Fee Related CN209014587U (en) 2018-02-13 2018-06-29 a cover

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