Disclosure of Invention
The present application is based on the discovery and recognition by the inventors of the following facts and problems:
the invention provides a fecal occult blood detection device which comprises a main shell, a sampling rod, a water drain valve, an upper cover, a lower cover and a test paper rack. The device integrates functions of excrement sample collection, dissolution, chromatography, test strip detection and the like, can finish sample collection and fecal occult blood detection by an immunity method at one time, and is suitable for self-service fecal occult blood detection of testers at any place and time such as families, hospitals and the like. The device carries and easy and simple to handle, with low costs, has simplified the detection procedure, and whole process need not open faecal liquid, can realize the autonomous detection of detector moreover, has alleviateed medical staff's burden, improves colorectal cancer screening rate, reduces the incidence and the mortality of colorectal cancer.
To this end, in a first aspect of the invention, the invention proposes a fecal occult blood detection device. According to an embodiment of the invention, the fecal occult blood detection device comprises:
the detection device comprises a main shell, a first detection device and a second detection device, wherein the two ends of the main shell are opened, and a first tube cavity and a second tube cavity are defined; a water through hole is formed in the bottom end of the middle pipe wall and is used for communicating the first pipe cavity with the second pipe cavity; the first pipe cavity is provided with a first lock catch, and the first lock catch is arranged above the water through opening;
the shape of the upper cover is matched with the top end opening of the second tube cavity;
the lower cover is provided with a water discharge valve port, the water discharge valve port is arranged right below the first pipe cavity, and the shape of the lower cover is matched with the opening at the bottom end of the main shell;
the test paper holder is axially arranged in the second cavity along the main shell and is used for accommodating a test paper strip;
a sampling wand axially disposed in the first lumen along the main housing from the detection port;
the water drain valve penetrates through the water drain valve port and is arranged in the first pipe cavity along the axial direction of the main shell; the water drain valve is provided with a second lock catch, and the second lock catch is in buckle connection with the first lock catch; the water drain valve, the sampling rod and the inner wall of the first tube cavity jointly define an accommodating space, and the accommodating space is used for accommodating preservation liquid;
wherein the upper cover, the lower cover, the test paper rack, the sampling stick or the water drain valve is made of ABS,polyamide 6, polypropylene or polyethylene.
The device provided by the embodiment of the invention integrates functions of excrement sample collection, dissolution, chromatography, test strip detection and the like, can complete sample collection and occult blood in stool by an immune method at one time, and is suitable for self-service occult blood detection of testers at any place and time such as families and hospitals. The device simple structure, manufacturing process is simple and convenient, with low costs, and carries and easy and simple to handle, has simplified the detection procedure, and whole process need not open faecal liquid, can realize the autonomous detection of detector moreover, has alleviateed medical staff's burden, improves colorectal cancer screening rate, reduces the incidence and the mortality of colorectal cancer.
According to an embodiment of the present invention, the apparatus may further include at least one of the following additional features:
according to the embodiment of the invention, the position of the first lock catch is set according to the volume of the preservation solution required by the test strip detection.
According to an embodiment of the present invention, the sampling wand is movably disposed in the first lumen.
According to an embodiment of the present invention, the drain valve is movably disposed in the first lumen.
According to an embodiment of the present invention, the drain valve moves downward, the second locker is separated from the first locker, and the preservation solution in the accommodation space may flow into the second lumen through the water passage port.
According to the embodiment of the invention, the test paper rack is connected with the middle pipe wall in a buckling mode so as to fix the test paper rack.
According to the embodiment of the invention, the test paper rack is provided with the test paper rack groove, and the test paper rack groove is arranged on one surface of the test paper rack far away from the middle pipe wall so as to accommodate the test paper.
According to the embodiment of the invention, the bottom end of the test paper rack is provided with a through hole so as to enable the test paper to be in contact with the preservation solution flowing into the second tube cavity.
According to an embodiment of the present invention, the first lumen is provided with a first lumen groove provided between the first lock catch and the water passage port.
According to the embodiment of the invention, the water drain valve is provided with a water drain groove and a sealing groove, the water drain groove is matched with the first pipe cavity groove, and the sealing groove is matched with the water drain valve port.
According to the embodiment of the invention, the sampling rod is provided with a convex end of the sampling rod, and the convex end of the sampling rod is matched with the detection port.
According to the embodiment of the invention, the water discharging groove, the sealing groove and the sampling rod groove are internally provided with sealing rings.
According to an embodiment of the invention, the main housing is transparent. In some embodiments, the main housing is made of polycarbonate, acrylonitrile butadiene styrene plastic, polystyrene plastic, polymethyl methacrylate, acrylonitrile styrene resin, or metal.
Detailed Description
Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings. The embodiments described below with reference to the drawings are illustrative and intended to be illustrative of the invention and are not to be construed as limiting the invention.
The invention aims to provide an integrated device for sampling excrement and automatically testing occult blood, which integrates the collection of excrement samples and the automatic testing of occult blood of excrement and is an auxiliary in-vitro disposable diagnostic device suitable for hospitals and families.
The invention provides a fecal occult blood detection device. According to an embodiment of the present invention, referring to fig. 1 to 9, the fecal occult blood detecting device includes:
the detection device comprises a main shell 1, wherein two ends of the main shell 1 are opened, afirst tube cavity 12 and asecond tube cavity 13 are defined, the opening at the top end of thefirst tube cavity 12 is adetection port 15, and thefirst tube cavity 12 is connected with thesecond tube cavity 13 through amiddle tube wall 11; a water throughport 18 is formed at the bottom end of themiddle pipe wall 11, and the water throughport 18 is used for communicating thefirst pipe cavity 12 with thesecond pipe cavity 13; thefirst tube cavity 12 is provided with afirst lock catch 17, and thefirst lock catch 17 is arranged above the water through opening 18;
theupper cover 4 is matched with the top end opening 23 of the second tube cavity in shape;
thelower cover 5 is provided with a waterdischarge valve port 24, the waterdischarge valve port 24 is arranged right below thefirst pipe cavity 12, and the shape of thelower cover 5 is matched with the bottom end opening 19 of the main shell;
thetest paper holder 6 is arranged in thesecond cavity 13 along the axial direction of the main shell 1, and is used for accommodating atest paper strip 22;
asampling wand 2, saidsampling wand 2 being axially disposed in saidfirst lumen 12 along said main housing 1 from saiddetection port 15;
thewater drain valve 3 penetrates through the waterdrain valve port 24 and is arranged in thefirst pipe cavity 12 along the axial direction of the main shell 1; thewater drain valve 3 is provided with asecond lock catch 16, and thesecond lock catch 16 is connected with thefirst lock catch 17 in a clamping manner; thewater drain valve 3, thesampling rod 2 and the inner wall of thefirst tube cavity 12 jointly define a containing space, and the containing space is used for containing preserving fluid;
wherein theupper cover 4, thelower cover 5, thetest paper rack 6, thesampling rod 2 or thewater drain valve 3 are made of ABS,polyamide 6, polypropylene or polyethylene.
The inventor finds that the device integrates functions of excrement sample collection, dissolution, chromatography, test strip detection and the like, can finish sample collection and occult blood detection by an immunity method once, and is suitable for self-service occult blood detection of testers at any place and time such as families, hospitals and the like. The device simple structure, manufacturing process is simple and convenient, with low costs, and carries and easy and simple to handle, has simplified the detection procedure, and whole process need not open faecal liquid, can realize the autonomous detection of detector moreover, has alleviateed medical staff's burden, improves colorectal cancer screening rate, reduces the incidence and the mortality of colorectal cancer.
According to an embodiment of the present invention, referring to fig. 2, the position of thefirst latch 17 is set according to the volume of the preservation solution required for thetest strip 22 to detect. When thedrain valve 3 moves downward to separate thesecond lock 16 from thefirst lock 17, the preservation solution in the accommodating space may flow into thesecond lumen 13 through thewater passage port 18, and when the air pressures of thefirst lumen 12 and thesecond lumen 13 reach a balance, the preservation solution does not flow any more, and at this time, the volume of the preservation solution flowing into thesecond lumen 13 needs to meet the detection requirement of thetest strip 22 and avoid an excess amount.
In accordance with an embodiment of the present invention, and with reference to FIG. 1, thesampling wand 2 is movably disposed within thefirst lumen 12. The inventors first pull out thesampling wand 2 and use thecollection end 25 of the sampling wand to collect a stool sample. Then, thesampling rod 2 is inserted back into thefirst tube cavity 12, and the device is shaken, so that the excrement sample and the in-tube preservation solution are fully mixed uniformly.
According to an embodiment of the present invention, referring to fig. 1, thewater discharge valve 3 is movably disposed in thefirst lumen 12. When thedrain valve 3 moves downwards to separate thesecond lock 16 from thefirst lock 17, the preservation solution in the accommodating space can flow into thesecond lumen 13 through thewater passage port 18, the test strip sample pad is in contact with the preservation solution flowing into thesecond lumen 13, and the preservation solution starts to run out of the test strip through the chromatography action of thetest strip 22.
According to an embodiment of the present invention, referring to fig. 1, 2 and 6, thedrain valve 3 is moved downward, thesecond locking catch 16 is separated from the first lockingcatch 17, and the preservation solution in the accommodation space can flow into thesecond lumen 13 through thewater passage port 18.
According to an embodiment of the present invention, referring to fig. 1, 2 and 7, thetest paper holder 6 is snap-fit connected to themiddle tube wall 11 so as to fix thetest paper holder 6. It should be noted that themiddle tube wall 11 is a common tube wall of thefirst tube cavity 12 and thesecond tube cavity 13, and the three-dimensional shape of the middle tube wall changes correspondingly with the change of the three-dimensional shapes of the first tube cavity and the second tube cavity. For example, in some embodiments, when the first lumen is a circular lumen and the second lumen is a rectangular lumen, the cross section of thesecond lumen 13 is not a complete rectangle, but an irregular rectangle with one side being an arc.
According to an embodiment of the present invention, referring to fig. 1, 2 and 7, thetest paper holder 6 is provided with a testpaper holder groove 21, and the testpaper holder groove 21 is arranged on a surface of thetest paper holder 6 far away from themiddle tube wall 11 so as to accommodate atest paper strip 22.
According to the embodiment of the present invention, referring to fig. 7, the bottom end of thetest paper holder 6 is provided with a throughhole 20 so as to make thetest paper strip 22 contact with the preservative fluid flowing into thesecond lumen 13. Further, the preservation solution starts the strip running test by the chromatography of the test strip.
According to an embodiment of the present invention, referring to fig. 2, thefirst lumen 12 is provided with afirst lumen groove 27, and thefirst lumen groove 27 is provided between thefirst latch 17 and thewater passage port 18. According to some embodiments of the present invention, referring to fig. 6, thewater discharge valve 3 is provided with a water discharge groove 9 and a sealinggroove 10, the water discharge groove 9 is adapted to thefirst lumen groove 27, and the sealinggroove 10 is adapted to the waterdischarge valve port 24. According to further embodiments of the present invention, and with reference to FIG. 5, thesampling wand 2 is provided with a sampling wandmale end 14, the sampling wandmale end 14 fitting into thedetection port 15. Furthermore, the fecal occult blood detection device according to the embodiment of the invention has more stable assembly of parts, better sealing performance of the first tube cavity and the second tube cavity of the liquid storage before detection, can more fully ensure the dryness in the tube cavity of the test strip, effectively plays a role in protecting the humidity-sensitive colloidal gold test strip, and avoids the problems of failure or inaccurate result of the test strip caused by humid environment.
According to the embodiment of the invention, sealingrings 8 are arranged in the water discharging groove 9, the sealinggroove 10 and the sampling rod groove 7. Furthermore, the first cavity and the second cavity of the liquid storage tube before detection have better sealing performance.
According to an embodiment of the invention, the main housing 1 is transparent. In some embodiments, the main housing is made of polycarbonate, acrylonitrile butadiene styrene plastic, polystyrene plastic, polymethyl methacrylate, acrylonitrile styrene resin, or metal. Furthermore, the detection result can be conveniently and directly observed by a detector.
The invention has the following beneficial effects:
1. the integrated device for sampling excrement and automatically testing occult blood has the advantages of small volume, portability, integration of sampling, dissolving, chromatography and occult blood detection by an immunization method, simple and convenient operation, simplified operation process and clinical application value.
2. A circular tube cavity (namely a first tube cavity containing preservation solution) and a rectangular tube cavity (namely a second tube cavity containing an immunity test strip) are arranged in the excrement sampling and occult blood self-testing integrated device, and dissolution, chromatography and detection can be directly completed in the device after sampling is completed, excrement does not need to be contacted in the process, peculiar smell diffusion and excrement liquid dripping pollution are effectively prevented, and the detection process is safe and sanitary.
3. The examiner can independently complete sampling, detection and interpretation, the problem of low examination rate caused by difficult sampling and inconvenient delivery in hospitals is solved, the workload of medical staff is reduced, and the intestinal cancer screening rate is improved.
4. Excrement sampling and occult blood self-test integrated device, liquid storage circular lumen (being the first lumen) and detection rectangular lumen (being the second lumen, built-in immunity test paper strip) are airtight independent relatively respectively before detecting, utilize the valve that drains to realize the flow of liquid during the detection, fully guaranteed the aridity in the test paper strip lumen, can effectively play the effect of protection moisture sensitive colloidal gold test paper strip, avoid the test paper strip because of the environmental humidity arouses inefficacy or the inaccurate scheduling problem of result.
The invention is further illustrated by the following examples.
Example 1 Structure of the device
Referring to fig. 1-9, the invention provides an integrated device for sampling feces and testing occult blood automatically, which comprises a main shell 1, asampling rod 2, awater drain valve 3, anupper cover 4, alower cover 5 and atest paper rack 6; the sampling rod groove 7 contains a samplingrod sealing ring 8, and the drain valve drain groove 9 and the drainvalve sealing groove 10 respectively contain a drainvalve sealing ring 8. The main housing 1 is combined by afirst lumen 12 and asecond lumen 13. The shape of theupper cover 4 is matched with the top end opening 23 of the second pipe cavity, and the shape of thelower cover 5 is matched with the bottom section of the main shell 1. The diameter of theconvex end 14 of the sampling rod is closely matched with the inner diameter of thedetection port 15. The diameter of the bottom of thewater drain valve 3 is closely matched with the inner diameter of thefirst pipe cavity 12, and a lock catch (a second lock catch) 16 arranged on the water drain valve is matched with a lock catch (a first lock catch) 17 at the water drain valve opening of the main shell.
Thewater discharge valve 3 is provided with a water discharge groove 9 and a sealinggroove 10, thewater discharge valve 3 is pulled downwards to be separated from a clampingposition 26, so that thefirst tube cavity 12 is communicated with thesecond tube cavity 13 through the water throughhole 18, the liquid circulation is realized, and meanwhile, the liquid can be prevented from leaking to the outside of the device. The position of the water drain valve setting lock catch (second lock catch) 16 after being connected with the main casing water drain valve port lock catch (first lock catch) 17 in a buckling manner is the position of the clampingposition 26.
The position of the waterdischarge valve stopper 26 is designed to be quantitatively set according to the volume required for detection of thetest strip 22.
The main shell material is made of polycarbonate (PC for short) or transparent acrylonitrile (A) -butadiene (B) -styrene (S) plastic (ABS for short), polystyrene plastic (PS for short), polymethyl methacrylate (PMMA) namely organic glass, acrylonitrile (A) -styrene (S) resin (AS for short) or special metal and the like. The sealing ring is made of silica gel. The other parts are made of materials such as ABS, polyamide 6 (PA 6), polypropylene (PP), Polyethylene (PE), etc., and the materials of the different parts may be the same or different. In addition, when the main shell, the sealing ring or other parts are made of the materials as described above, the detection effect (e.g., accuracy) of the integrated device for sampling the excrement and self-testing the occult blood is better.
The tube body of the integrated device for sampling the excrement and self-testing the occult blood is transparent, so that the detection result can be conveniently and directly observed.
Thelower cover 5 and the main casing 1 are welded together and sealed using ultrasonic welding technology (or bonded and sealed with the main casing using methylene chloride ethyl acetate as an adhesive). Thetest strip 22 is then placed in thetest strip holder 6, and theupper cover 4 and the main housing 1 are welded together and sealed by ultrasonic welding (or the lower cover and the main housing are bonded and sealed by using dichloromethane-ethyl acetate as an adhesive).
EXAMPLE 2 installation sequence of devices
1. And placing asealing ring 8 in the groove 7 of the sampling rod, and respectively placing asealing ring 8 in the water drain groove 9 of the water drain valve and the sealinggroove 10 of the water drain valve to finish the primary assembly process of the sealing ring.
2. Thelower cover 5 is aligned with the main housingbottom end 19, and thelower cover 5 is welded to the main housing 1 integrally and sealed by an ultrasonic welding machine.
3. Thetest paper holder 6 is inserted into thesecond lumen 13 from the top of the main housing.
4. And (3) loading thetest strip 22 into the teststrip holder groove 21 to complete the installation of thetest strip 22.
5. Theupper cover 4 is aligned with the second lumen top end, and theupper cover 4 is welded to the main housing 1 integrally and sealed by an ultrasonic welding machine.
6. Thewater discharge valve 3 is inserted into the waterdischarge valve port 24 of the lower cover until the water discharge valve lock catch (second lock catch) 16 is locked with the water discharge valve port lock catch (first lock catch) 17 of the main shell body in a matching manner.
7. The preservation solution is injected into thefirst lumen 12 from thedetection port 15, and thecollection end 25 of the sampling rod is inserted into the uppercover detection port 15. This step completes all assembly.
EXAMPLE 3 method of Using the device
1. Thesampling wand 2 is pulled out and the faecal sample is collected using thecollection end 25 of the sampling wand.
2. Thesampling rod 2 is inserted back into thefirst tube cavity 12, and the instrument is shaken, so that the excrement and the liquid in the tube are fully and uniformly mixed.
3. Thewater drain valve 3 is pulled down to be separated from the clampingposition 26, so that thefirst tube cavity 12 is communicated with thesecond tube cavity 13, and the liquid flows from the water throughport 18 of thefirst tube cavity 12 to thesecond tube cavity 13. The test strip sample pad is contacted with liquid, and the liquid starts to run for detection through the chromatography of the test strip.
4. And observing the color development conditions of the detection line and the quality control line at the combined pad of the test strip after 10min of detection, comparing the color cards, and judging the detection result.
In the description of the present invention, it is to be understood that the terms "central," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," "circumferential," and the like are used in the orientations and positional relationships indicated in the drawings for convenience in describing the invention and to simplify the description, and are not intended to indicate or imply that the referenced devices or elements must have a particular orientation, be constructed and operated in a particular orientation, and are therefore not to be considered limiting of the invention.
Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of the present invention, "a plurality" means at least two, e.g., two, three, etc., unless specifically limited otherwise.
In the present invention, unless otherwise expressly specified or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally formed; may be mechanically coupled, may be electrically coupled or may be in communication with each other; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood by those of ordinary skill in the art according to specific situations.
In the present invention, unless otherwise expressly stated or limited, the first feature "on" or "under" the second feature may be directly contacting the first and second features or indirectly contacting the first and second features through an intermediate. Also, a first feature "on," "over," and "above" a second feature may mean that the first feature is directly on or obliquely above the second feature, or that only the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature may be directly under or obliquely under the first feature, or may simply mean that the first feature is at a lesser elevation than the second feature.
In the description herein, references to the description of the term "one embodiment," "some embodiments," "an example," "a specific example," or "some examples," etc., mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, the schematic representations of the terms used above are not necessarily intended to refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples. Moreover, various embodiments or examples and features of different embodiments or examples described in this specification can be combined and combined by one skilled in the art without contradiction.
Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention, and that variations, modifications, substitutions and alterations can be made to the above embodiments by those of ordinary skill in the art within the scope of the present invention.