CN111380724B - Body fluid sample sampling and detecting device - Google Patents
Body fluid sample sampling and detecting device Download PDFInfo
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- CN111380724B CN111380724B CN202010331910.3A CN202010331910A CN111380724B CN 111380724 B CN111380724 B CN 111380724B CN 202010331910 A CN202010331910 A CN 202010331910A CN 111380724 B CN111380724 B CN 111380724B
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/02—Devices for withdrawing samples
- G01N1/10—Devices for withdrawing samples in the liquid or fluent state
- G01N1/14—Suction devices, e.g. pumps; Ejector devices
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/38—Diluting, dispersing or mixing samples
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
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- Food Science & Technology (AREA)
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Abstract
The invention provides a body fluid sample collecting and detecting device which comprises a collecting rod (10) and a main pipe (20), wherein the collecting rod (10) is used for collecting a body fluid sample, the main pipe (20) is used for diluting the body fluid sample collected by the collecting rod (10), the main pipe (20) is cylindrical, the main pipe (20) comprises a first cavity (21) and a second cavity (22), the collecting rod (10) can extend from the first cavity (21) to the second cavity (22), the second cavity (22) contains diluent, and an end part, far away from the first cavity (21), of the second cavity (22) is provided with an end sealing piece (20 s 1) capable of being punctured. The body fluid sample collecting and detecting device provided by the invention has a reasonable structure, and can conveniently collect and detect body fluid samples.
Description
Technical Field
The invention relates to the field of medical instruments, in particular to a body fluid sample collection and detection device.
Background
For collection and inspection of body fluids such as blood, the functional integration of the existing collection and inspection device is not high, and rapid detection is difficult to achieve through simple operation.
Disclosure of Invention
The present invention aims to overcome or at least alleviate the above-mentioned disadvantages of the prior art and to provide a body fluid sample collection device.
The invention provides a body fluid sample collection and detection device, which comprises a collection rod and a main pipe, wherein the collection rod is used for collecting a body fluid sample, the main pipe is used for diluting the body fluid sample collected by the collection rod, and the main pipe is used for collecting the body fluid sample,
the main pipe is cylindrical, the main pipe comprises a first cavity and a second cavity, the collecting rod can extend from the first cavity to the second cavity,
the second chamber contains a diluent and the end of the second chamber remote from the first chamber is provided with an end seal that can be pierced.
In at least one embodiment, the first and second chambers are sealingly isolated from one another when the collection wand extends from the first chamber into the second chamber and when the collection wand is in place with the main tube.
In at least one embodiment, an intermediate seal is provided between the first and second chambers that is penetrable by the collection wand, the intermediate seal sealingly isolating the first and second chambers from one another.
In at least one embodiment, the collection wand includes a handle and a collection tube,
the handle can be in close fit with the main tube at the end of the first cavity remote from the second cavity,
the collection tube is connected to the handle, the collection tube is capable of drawing the body fluid sample by capillary action, and the collection tube is capable of extending at least partially into the second cavity.
In at least one embodiment, the collection tube is tubular, and the region of the handle connected to the collection tube is provided with an air vent, which is in communication with the collection tube, thereby enabling the collection tube to form a capillary action to draw the body fluid sample.
In at least one embodiment, the collection tube comprises an inner post and an outer sleeve,
the inner column is of a solid structure, the outer sleeve is of a hollow tubular structure,
the outer sleeve can be sleeved at the end part of the inner column, and a gap which is penetrated in the axial direction of the outer sleeve is formed between the outer sleeve and the inner column, so that the collecting tube can form capillary action to suck the body fluid sample.
In at least one embodiment, the collection tube is integral with the handle, or
The collection tube and the handle are configured to be nestably connected to one another.
In at least one embodiment, the collection sticks include a first collection stick and a second collection stick,
the first collection stick is used for sealing and isolating the first cavity and the second cavity from each other when the body fluid sample is not introduced into the main pipe,
the second collection stick is used for collecting the body fluid sample and replacing the first collection stick when the body fluid sample is introduced into the main pipe.
In at least one embodiment, the second collection wand includes a handle and a collection tube,
the handle can be in close fit with the main tube at the end of the first cavity remote from the second cavity,
the collection tube is connected with the handle, the collection tube can absorb the body fluid sample by utilizing capillary action, and the collection tube can at least partially extend into the second cavity;
the primary collection wand includes the handle and does not include the collection tube.
In at least one embodiment, the body fluid sample collection device further comprises a cartridge,
the inner cavity of the detection box is provided with a puncturing device which can puncture the end sealing piece,
the inner cavity of the detection box is also provided with a detection device,
the main tube can extend into the interior cavity of the cartridge to puncture the end seal and allow the diluted body fluid sample to flow to the testing device.
In at least one embodiment, the detection device comprises a test strip and/or a reagent carrying device.
In at least one embodiment, the cartridge comprises a cartridge and a cartridge sleeve,
the box sleeve is cylindrical, is open at one end and closed at the other end, is made of transparent materials,
the clamping plug is accommodated in the inner cavity of the box sleeve and used for fixing the detection device.
In at least one embodiment, the body fluid sample collection device further comprises a pressing member capable of abutting against an end of the collection stick fitted to the main tube to fit the main tube and the cartridge in place.
In at least one embodiment, the body fluid sample collection device is used to collect a blood sample.
The body fluid sample collecting and detecting device provided by the invention has a reasonable structure, and can conveniently collect and detect body fluid samples.
Drawings
Fig. 1 is a cross-sectional view of a body fluid sample testing device according to one embodiment of the present invention.
Fig. 2 is a schematic view of a collection stick of a body fluid sample testing device according to a first embodiment of the present invention.
Fig. 3 is a cross-sectional view of fig. 2.
Fig. 4 is a schematic structural view of a main tube of the body fluid sample testing device according to the first embodiment of the present invention.
Fig. 5 is a sectional view of a collection stick and a main tube of a body fluid sample testing device according to a first embodiment of the present invention assembled together.
Fig. 6 is a cross-sectional view of a cartridge of a body fluid sample testing device according to a first embodiment of the present invention.
Fig. 7 is a schematic view, partially in section, of fig. 6.
Fig. 8 is a front view of fig. 6.
Fig. 9 is an exploded schematic view of a cartridge of a body fluid sample testing device according to a first embodiment of the present invention.
FIG. 10 is a cross-sectional view of the reagent carrier device of FIG. 9.
Fig. 11 is a schematic view of the pressing member of the body fluid sample testing device according to the first embodiment of the present invention mated with the collection stick and the main tube.
Fig. 12 is a cross-sectional view of a collection stick of a body fluid sample testing device according to a second embodiment of the present invention.
Fig. 13 is a sectional view of a collection stick and a main tube of a body fluid sample testing device according to a third embodiment of the present invention assembled together.
Fig. 14 is a schematic view of a collection stick of a body fluid sample testing device according to a fourth embodiment of the present invention.
Fig. 15 is an exploded view of fig. 14.
Fig. 16 and 17 are cross-sectional views of fig. 15 in two different directions.
Fig. 18 is a cross-sectional view of a portion of the structure of fig. 14.
Fig. 19 is a cross-sectional view of a main tube of a body fluid sample testing device according to a fourth embodiment of the present invention.
Fig. 20 is a cross-sectional view of a collection stick and a main tube of a body fluid sample testing device according to a fourth embodiment of the present invention assembled together.
Reference numerals illustrate:
10, collecting a rod; 10h of exhaust holes;
11 handles; 111 a first section of the handle; 112 a second section of the handle; 113a third section of the handle; 113a connection section; 11f a flexible material; 11b flange portions; 11c engaging portions;
a 12-collection tube; 121 inner column; 122 outer jackets;
20 a main pipe; 20s1 end seals; 20s2 middle seal; 21a first chamber; 22a second chamber; a 23 baffle; a 23h mesopore; a 231 separator; 232 sleeves; 2321 a sleeve first portion; 2322 a sleeve second portion;
30 a detection box; 31a detection device;
311 test paper; 3111 a first region; 3112 a second zone; 3113 a third region; 3114 a fourth region;
312 reagent carrying means; 3121 coverslips; 3122 slides; 3123 dye pads; 3124 a carrier layer; 3125 absorbent pad;
32 blocking; 321, a plug is blocked; 321a sealing portions; 322 to block the body; 322a motherboard; 322b side plate; 32g of clamping groove;
33 boxes; 331 puncturing means; 331a drainage portion; 332 a positioning strip;
40 pressing piece; s sealing rings; g slit.
Detailed Description
Exemplary embodiments of the present invention are described below with reference to the accompanying drawings. It should be understood that these specific illustrations are for the purpose of illustrating how one skilled in the art may practice the invention, and are not intended to be exhaustive of all of the possible ways of practicing the invention, nor to limit the scope of the invention.
A body fluid sample collection device according to the present invention will be described with reference to fig. 1 to 20. The body fluid collected by the device is preferably, but not limited to, blood. It may also be saliva or urine, for example.
The radial direction in the present invention corresponds to the radial direction of the collection tube 12, and the axial direction in the present invention corresponds to the axial direction of the collection tube 12, unless otherwise specified. Reference herein to "upper" and "lower" is made to the orientation of the figure.
(first embodiment)
First, a body fluid sample collection device according to a first embodiment of the present invention will be described with reference to fig. 1 to 11.
Referring to fig. 1, the body fluid sample collection device includes a collection stick 10, a main tube 20, a detection cartridge 30, and a pressing member 40 (not shown in fig. 1). The collection stick 10 is used to collect a quantity of a body fluid sample and transfer the body fluid sample into the main tube 20 for dilution. The collector bar 10 can be inserted into the main tube 20 and is tightly fitted with the main tube 20. The main tube 20 is for receiving a diluting fluid for diluting a body fluid sample, and the main tube 20 can be inserted into the cartridge 30 and tightly fitted with the cartridge 30. The cartridge 30 is for accommodating the detecting device 31 (see also fig. 9), and the cartridge 30 can pierce the main tube 20 to allow the diluent containing the body fluid sample to flow to the detecting device 31. The pressing member 40 serves to help the collection stick 10 and the main tube 20 assembled together to be more thoroughly inserted into the cartridge 30 and to be closely assembled with the cartridge 30.
Referring to fig. 2 and 3, an acquisition rod 10 according to the present embodiment is described.
In this embodiment, the collection wand 10 includes a handle 11 and a collection tube 12.
The handle 11 is for grasping by an operator, and the handle 11 can be assembled with the main tube 20 and the cartridge 30 in a nested manner.
The handle 11 comprises a handle first section 111, a handle second section 112 and a handle third section 113 in the shape of a stepped cylinder. Wherein the first handle section 111 has a radial dimension that is greater than the radial dimension of the second handle section 112, and the second handle section 112 has a radial dimension that is greater than the radial dimension of the third handle section 113. The second handle section 112 is insertable into a first cavity 21 of the main tube 20 described below, and the first handle section 111 is insertable into an interior cavity of the cartridge 30 described below. The handle third section 113 is adapted to be connected to the collection tube 12.
Preferably, the outer circumferences of the first and second handle sections 111 and 112 are coated with a flexible material 11f to increase the tightness of the assembly and to avoid leakage of the liquid when the handle 11 is assembled with the main tube 20 and the cartridge 30. Preferably, the flexible material 11f is a soft gel that is formed to the outer periphery of the handle first section 111 and the handle second section 112 by an over-molding process. Preferably, the flexible material 11f forms a ring of annular protrusions at each of the handle first section 111 and the handle second section 112 to enhance the sealing effect.
For convenience of description throughout, the third section 113 of the handle in the axial region indicated by the brackets in fig. 3 is referred to as the connecting section 113a. The connecting section 113a is tubular and connects the collection tubes 12. The collection tube 12 is in the form of a thin tube with a lumen for drawing a body fluid sample. In the present embodiment, the connection section 113a is integrally formed with the collection tube 12 and is connected seamlessly.
The peripheral wall of the end of the connecting section 113a remote from the collection tube 12 is provided with an exhaust hole 10h, the exhaust hole 10h communicates with the inner cavity of the connecting section 113a, and the exhaust hole 10h also communicates with the inner cavity of the collection tube 12. This allows air to pass axially through collection tube 12 and, in turn, when the end of collection tube 12 distal from handle 11 contacts a body fluid sample, the body fluid sample can wick into and fill the lumen of collection tube 12.
Preferably, collection tube 12 is made of a transparent material so that an operator can easily view the amount of bodily fluid sample that is drawn by collection tube 12 as the bodily fluid sample rises along the lumen of collection tube 12. Preferably, the peripheral wall of the collection tube 12 is provided with graduations for indicating the amount of the body fluid sample.
The outer circumference of the handle third section 113 is formed with a ring of flange portions 11b protruding radially outward, the flange portions 11b being adapted to cooperate with a sleeve 232 described below to seal off a sleeve first portion 2321 and a sleeve second portion 2322 in the axial direction.
Preferably, the outer periphery of the third section 113 of the handle is provided with a seal ring S, which is adjacent to the axial end face of the flange portion 11b near the collecting tube 12 in the axial direction. The exhaust hole 10h is at least partially not shielded by the sealing ring S. The seal ring S is made of, for example, a rubber material.
Next, referring to fig. 4 and 5, the structure of the main tube 20 and its mounting relationship with the collector bar 10 will be described.
The main pipe 20 is tubular, and in the present embodiment, a cross section of the main pipe 20 perpendicular to the axial direction is substantially D-shaped.
The inner cavity of the main tube 20 has a barrier 23, the barrier 23 dividing the inner cavity of the main tube 20 in axial direction into two parts, a first cavity 21 and a second cavity 22.
The first chamber 21 is intended primarily to be secured to the second section 112 of the handle and the second chamber 22 is intended to receive a dilution liquid for diluting a body fluid sample.
The end of the second chamber 22 remote from the first chamber 21 is closed by an end seal 20s1, the end seal 20s1 being capable of being pierced by a piercing device 331 described below to allow a diluted body fluid sample to flow out of the second chamber 22. Preferably, the end seal 20s1 is aluminum foil, and preferably, the end seal 20s1 made of aluminum foil is connected to the main pipe 20 (i.e. the main pipe 20 and aluminum foil are heated and connected together) by a heat sealing process, and the main pipe 20 is made of plastic, for example.
The barrier 23 functions to seal the second chamber 20 in addition to separating two chambers in the inner chamber of the main pipe 20. Such seals include seals in both cases, the first case when the collector bar 10 is not extending into the main tube 20 and the second case after the collector bar 10 extends into the main tube 20.
The spacer 23 includes a spacer 231 at an outer peripheral portion and a sleeve 232 at an inner peripheral portion.
The outer peripheral portion of the partition 231 is connected to the inner peripheral wall of the main pipe 20, and the inner peripheral portion of the partition 231 has a middle hole 23h communicating the first chamber 21 and the second chamber 22.
The sleeve 232 comprises two parts axially on either side of the partition 231, wherein the sleeve first part 2321 faces the first chamber 21 and the sleeve second part 2322 faces the second chamber 22. The inner diameter of the sleeve first portion 2321 is slightly larger than the inner diameter of the middle hole 23h, and the inner diameter of the sleeve first portion 2321 is approximately equal to the outer diameter of the flange portion 11b of the collector bar 10, and the inner diameter of the sleeve second portion 2322 is approximately equal to the inner diameter of the middle hole 23h.
Referring to FIG. 4, when the collector bar 10 is not extending into the main tube 20, the end of the sleeve second portion 2322 is closed by the intermediate seal 20s2. Preferably, the intermediate seal 20s2 is aluminum foil, and preferably, the intermediate seal 20s2 of aluminum foil is attached to the sleeve second portion 2322 by a heat sealing process.
It should be appreciated that during production, one of the end seal 20s1 and the intermediate seal 20s2 (e.g., the intermediate seal 20s 2) is first sealed to the main pipe 20, after which diluent is added to the second chamber 22, and finally, the other of the end seal 20s1 and the intermediate seal 20s2 (e.g., the end seal 20s 1) is sealed. Thus, the diluent is loaded into the second chamber 22 and does not leak from the main pipe 20 without the end seal 20s1 and the intermediate seal 20s2 being punctured.
Referring to FIG. 5, as the collection rod 10 extends from the first chamber 21 into the main tube 20, the end of the collection tube 12 (which is preferably relatively sharp in shape) can puncture the middle seal 20s2 to extend further into the second chamber 22 and into contact with the diluent. When collection tube 12 is contacted with a diluent, the body fluid sample contained within collection tube 12 will dissolve into the diluent as the operator shakes main tube 20.
When the collecting rod 10 and the main pipe 20 are assembled in place, the sealing ring S is respectively pressed by the flange part 11b and the partition 231 positioned in the inner cavity of the first sleeve part 2321 in the axial direction, so that the second cavity 22 is sealed; preferably, the outer diameter of seal ring S is slightly larger than the inner diameter of sleeve first portion 2321. Meanwhile, the stepped portion between the handle first section 111 and the handle second section 112 abuts against the end of the main pipe 20 near the first cavity 21, and the handle second section 112 is connected with the inner peripheral wall of the first cavity 21 with interference fit.
In use, the assembled collection wand 10 and main tube 20 will be further loaded into the cartridge 30 to allow the diluted body fluid sample to flow to the testing device 31 located within the cartridge 30.
Next, the cartridge 30 according to the present invention is described with reference to fig. 6 to 10.
The detection cartridge 30 includes a cartridge case 33, a stopper 32, and a detection device 31. The stopper 32 and the detecting device 31 are mounted inside the cartridge 33, and the stopper 32 is used for fixing the detecting device 31.
First, the cartridge 33 is described with reference to fig. 6 to 8.
The case 33 has a cylindrical shape (or a box shape) with one end open and one end closed, and the open end thereof is used for the main pipe 20 to extend.
The bottom of the inner cavity of the box 33 is provided with a puncturing device 331, the puncturing device 331 being used for puncturing the end seal 20s1 of the main tube 20. Preferably, referring to fig. 7 and 8, the puncturing device 331 has a trapezoidal mesa shape with a small upper portion and a large lower portion so that sufficient sample diluent can flow into the cartridge 33 after the end seal 20s1 is punctured.
Preferably, in order to guide the sample dilution out, a plurality of axially extending channels are formed in the table-like lancing device 331. And more preferably, the middle of the puncturing device 331 forms a hollow cylindrical cavity, one side wall of which is opened to define a drain portion 331a, the drain portion 331a being directed toward a cartridge 32 described below to drain the sample diluent to a detection device 31 mounted to the cartridge 32.
Two opposing side wall portions in the interior cavity of the cartridge 33 are convexly formed with wedge-shaped, smaller-top, larger-bottom positioning bars 332, the positioning bars 332 being adapted to cooperate with the stoppers 32 described below to position the stoppers 32.
Next, the jam 32 and the detection device 31 are described with reference to fig. 9 and 10.
Referring to fig. 9, the stopper 32 includes a stopper head 321 and a stopper body 322. The stopper 321 has a tubular shape, and the main pipe 20 can pass through the stopper 321. The outer circumferential wall of the stopper 321 is adapted to cooperate with the inner circumferential wall of the box 33, and the inner circumferential wall of the stopper 321 is adapted to cooperate with the outer circumferential wall of the first section 111 of the handle and the outer circumferential wall of the main tube 20.
Preferably, the outer circumference of the stopper 321 is provided with an annular sealing portion 321a made of a flexible material for forming a seal with the cartridge 33.
The stopper body 322 has a plate shape for accommodating the detecting device 31, and the stopper body 322 can be positioned in cooperation with the side wall of the cartridge 33.
Specifically, the blocking body 322 includes a main plate 322a and two side plates 322b located at both sides of the main plate 322a and disposed perpendicular to the main plate 322 a. Side plate 322b is wedge-shaped with a smaller lower end and a larger upper end for mating positioning with positioning strip 332.
The surface of the main plate 322a, which is used to cling to the case 33, is formed with a plurality of concave clamping grooves 32g for embedding the detection device 31.
In the present embodiment, the detection device 31 includes a test paper 311 and a reagent carrying device 312.
The test paper 311 is, for example, a colloidal gold immunochromatography test paper, and includes, for example, a first region 3111, a second region 3112, a third region 3113, and a fourth region 3114, which are connected in this order. The first zone 3111 is a sample pad, the second zone 3112 is a gold-labeled pad, the third zone 3113 is a nitrocellulose membrane, and the fourth zone 3114 is a water-absorbent pad. A reaction line (T line) and a control line (C line) are provided in the third region 3113. When the test strip 311 is mounted to the stopper body 322, the first region 3111 faces downward (away from the stopper 321).
Referring to fig. 10, the reagent carrier 312 is, for example, a cover glass combination. It comprises a cover glass 3121, a glass slide 3122, a staining pad 3123, a bearing layer 3124 and a water absorbing pad 3125, wherein the staining pad 3123, the bearing layer 3124 and the water absorbing pad 3125 are sandwiched between the cover glass 3121 and the glass slide 3122.
The staining pad 3123 is made of a water absorbing material for absorbing and staining cells in the sample reagent. Preferably, the staining pad 3123 is partially exposed to the cover glass 3121 and the slide glass 3122.
The carrier layer 3124 is disposed immediately adjacent to the staining pad 3123 and is entirely contained between the coverslip 3121 and the slide 3122, the carrier layer 3124 being made of a water absorbent material (e.g., one or more of nitrocellulose membrane, non-woven fabric, hemofilter membrane, cellophane).
The absorbent pad 3125 is disposed at an end of the carrier layer 3124 remote from the dye pad 3123 for absorbing excess liquid.
When the reagent carrier 312 is mounted to the stopper body 322, the staining pad 3123 faces downward and the cover glass 3121 faces outward.
It should be understood that coverslip 3121 and slide 3122 may also be replaced by transparent plastic sheets.
In particular, since the transparent wall of the cassette 33 is in close contact with the reagent carrier 312 or is spaced only a small distance from the reagent carrier 312, the cover glass 3121 may be omitted, and the wall of the cassette 33 may be made to function as the cover glass 3121.
It should be appreciated that in this embodiment, there are two test strips 311 and reagent carrier devices 312, which may be particularly backed up to ensure reliability of detection. However, the number of the test strips 311 and the reagent carrying devices 312 may be set as required, and the present invention is not limited thereto.
Referring to fig. 11, the body fluid sample collection device according to the present invention preferably further includes a pressing member 40. The pressing member 40 can press against the handle 11 to help the main tube 20 connected to the handle 11 extend completely into the interior of the cartridge 30, ensuring the tightness of the device as a whole. For example, the interior of the first and second handle sections 111, 112 has cavities, and the push member 40 can extend into the bottom of the second handle section 112.
Next, a method of using the body fluid sample collection device according to the present embodiment will be described.
The collection stick 10, main tube 20 and test cassette 30 are not assembled together prior to use by an operator. In this case, the main tube 20 contains the diluent, and the detection device 31, the stopper 32, and the cartridge 33 are assembled together to form the detection cartridge 30.
In use, an operator first draws a sufficient sample of bodily fluid with the collection wand 10.
Thereafter, the collector bar 10 is extended from the first cavity 21 of the main tube 20 into the second cavity 22, and the collector bar 10 will puncture the middle seal 20s2. After the collection stick 10 is contacted with the diluent, it is shaken to mix the body fluid sample with the diluent. Also, after the collector bar 10 is assembled with the main tube 20 in place, the second chamber 22 is sealed and no internal liquid leaks.
Thereafter, the collection stick 10 and the main tube 20 assembled together are inserted into the test cassette 30, and the end seal 20s1 is pierced by the piercing device 331 at the bottom of the cassette 33, and the diluted body fluid sample flows to the test device 31. The process of assembling the collection stick 10 and the main tube 20 together with the cartridge 30 may be performed by the pressing member 40. After the whole of the collection stick 10 and the main tube 20 and the detection box 30 are assembled in place, the open end of the detection box 30 is sealed, and the internal liquid cannot leak.
After that, the operator can learn the detection result by observing the detection device 31. For example, the color development result of the test paper 311 is directly observed, and/or the body fluid sample collection device is horizontally placed in the placement area of the microscope for observation.
It should be understood that the pressing member 40 may be press-fitted to the collection stick 10 when the collection stick 10 and the main tube 20 are integrally assembled with the cartridge 30, or may be pre-fitted to the end of the collection stick 10.
(second embodiment)
Next, a body fluid sample collection device according to a second embodiment of the present invention will be described with reference to fig. 12. This embodiment is a modification of the first embodiment, and the description of the same portions as those of the first embodiment is omitted.
In this embodiment, the handle 11 of the collection stick 10 and the collection tube 12 are assembled after being manufactured separately.
The connecting section 113a of the lower end of the handle third section 113 of the handle 11 is tubular. Collection tube 12 can nest within the lumen of connecting segment 113a such that collection tube 12 and handle 11 are connected together. The outside diameter of collection tube 12 is equal to or slightly greater than the inside diameter of connecting section 113a.
(third embodiment)
Next, a body fluid sample collection device according to a third embodiment of the present invention will be described with reference to fig. 13. This embodiment is a modification of the first and second embodiments, and the description of the same portions as those of the second embodiment is omitted.
In this embodiment, a set of body fluid sample collection devices includes two collection sticks. One of the collection sticks is identical to the collection stick of the first embodiment or the second embodiment and is used to obtain a body fluid sample; another collection stick is shown in fig. 13 as an embedded cap of the main tube 20 sealing the second chamber 22 in place of the intermediate seal 20s2 of the first embodiment before the main tube 20 is opened to dilute the body fluid sample.
The collection stick for obtaining the body fluid sample has the same structure as the collection stick in the second embodiment in order to simplify the manufacturing process and reduce the manufacturing cost; whereas the collection stick 10 described above for sealing the secondary chamber 22 has only the handle 11 of the collection stick in the second embodiment and no collection tube 12.
The main pipe 20 in this embodiment has no intermediate seal.
Before use by an operator, the collection stick 10 for sealing the second chamber 22 is assembled with the main tube 20, and the second chamber 22 contains a diluent.
In use, the operator removes the collection stick 10 of fig. 13 and inserts the collection stick, from which a body fluid sample has been collected, into the main tube 20.
This arrangement eliminates the need for the first embodiment to use a collection tube to puncture the intermediate seal, the collection rod is not easily damaged, and foreign matter that may be contaminated on the intermediate seal is not easily introduced into the diluent during dilution.
(fourth embodiment)
Next, a body fluid sample collection device according to a fourth embodiment of the present invention will be described with reference to fig. 14 to 20. This embodiment is a modification of the first embodiment, and the description of the same portions as those of the first embodiment is omitted.
Referring to fig. 14 to 18, in the present embodiment, the collection tube 12 is not formed in a hollow tubular shape, but includes an inner column 121 and an outer jacket 122 nested with each other.
The inner post 121 is a solid post, preferably the end of the inner post 121 is pointed.
The outer sleeve 122 is tubular, and the outer sleeve 122 is sleeved on the outer periphery of the inner post 121. The outer jacket 122 is secured to the inner post 121, such as by snap fit. Preferably, the ends of the jacket 122 are formed in a relatively sharp shape.
The inner diameter of the outer sleeve 122 is slightly larger than the outer diameter of the inner post 121 so that a gap is left between the inner post 121 and the outer sleeve 122, and the gap penetrates in the axial direction, for example, a gap G (refer to fig. 18) is left between the end of the outer sleeve 122 facing the handle 11 and the inner post 121 in the axial direction.
The annular gap between the inner post 121 and the outer sleeve 122 thus provides a capillary path for the body fluid sample.
In the present embodiment, the fitting portion of the handle 11 and the main pipe 20 is also modified. The handle 11 has an engagement portion 11c, and the engagement portion 11c has a substantially rectangular parallelepiped shape. Accordingly, referring to fig. 19 and 20, the sleeve first portion 2321 in the main pipe 20 is also formed in a square cylinder shape so as to be able to be fitted tightly with the engaging portion 11 c.
The collection tube 12 according to this embodiment is strong in structural strength and is not easily damaged.
It will be appreciated that the above-described embodiments, particularly the second to fourth embodiments, and some aspects or features thereof may be appropriately combined.
The present invention has at least one of the following advantages:
(i) The body fluid sample acquisition and detection device integrates the body fluid sample acquisition, dilution and detection devices in a sleeved mode, and can conveniently complete sample acquisition and detection.
(ii) The body fluid sample collection device according to the present invention includes, for example, a test paper 311 and a reagent carrying device 312, facilitating rapid observation of the detection result. In particular, the operator may directly place the body fluid sample collection device on the microscope, looking through the walls of the device, and observing the reagent carrying device 312.
(iii) The body fluid sample collecting and detecting device has good tightness, is not easy to introduce foreign matters in the detecting process, and has reliable detecting result.
Of course, the present invention is not limited to the above-described embodiments, and various modifications may be made to the above-described embodiments of the present invention by those skilled in the art in light of the present teachings without departing from the scope of the present invention. For example:
(i) The body fluid sample testing device according to the present invention may also be assembled without the push member 40 by manually pressing the handle by other means or by an operator.
(ii) The body fluid sample collection and detection device can be directly observed or can be observed by other devices when being used for detection by operators.
Claims (10)
1. A body fluid sample collection device comprising a collection stick (10) and a main tube (20), the collection stick (10) being for collecting a body fluid sample, the main tube (20) being for diluting the body fluid sample collected by the collection stick (10), wherein,
the main pipe (20) is cylindrical, the main pipe (20) comprises a first cavity (21) and a second cavity (22), the collecting rod (10) can extend from the first cavity (21) to the second cavity (22),
the second chamber (22) contains a diluent, the end of the second chamber (22) remote from the first chamber (21) is provided with a pierceable end seal (20 s 1),
the body fluid sample sampling device also comprises a tubular detection box (30), the inner cavity of the detection box (30) is provided with a puncturing device (331) which can puncture the end sealing piece (20 s 1), the inner cavity of the detection box (30) is also provided with a detection device (31), the detection device (31) comprises a test paper (311) and a reagent bearing device (312), the main pipe (20) can extend into the inner cavity of the detection box (30) so as to puncture the end sealing piece (20 s 1) and enable the diluted body fluid sample to flow to the detection device (31),
the collecting rod (10) comprises a collecting tube (12), the collecting tube (12) can absorb the body fluid sample by utilizing capillary action, the collecting tube (12) can at least partially extend into the second cavity (22), the collecting tube (12) comprises an inner column (121) and an outer sleeve (122), the inner column (121) is of a solid structure, the outer sleeve (122) is of a hollow tubular structure, the outer sleeve (122) can be sleeved at the end part of the inner column (121) and forms a gap which is communicated with the inner column (121) in the axial direction of the outer sleeve (122) so that the collecting tube (12) can form capillary action to absorb the body fluid sample,
an intermediate sealing element (20 s 2) which can be pierced by the collecting rod (10) is arranged between the first cavity (21) and the second cavity (22), the first cavity (21) and the second cavity (22) are sealed and isolated from each other by the intermediate sealing element (20 s 2), and the collecting rod (10), the main pipe (20) and the detecting box (30) are not assembled together before being used by an operator.
2. The body fluid sample collection device according to claim 1, wherein when the collection wand (10) extends from the first chamber (21) into the second chamber (22), and when the collection wand (10) and the main tube (20) are in place, the first chamber (21) and the second chamber (22) are hermetically isolated from each other.
3. The body fluid sample collection device according to claim 1, wherein the collection wand (10) comprises a handle (11),
the handle (11) can be tightly matched with the main pipe (20) at the end part of the first cavity (21) far away from the second cavity (22),
the collecting tube (12) is connected with the handle (11).
4. A body fluid sample collection device according to claim 3, wherein the collection tube (12) is tubular, the region of the handle (11) connected to the collection tube (12) is provided with a vent hole (10 h), and the vent hole (10 h) is in communication with the collection tube (12) so that the collection tube (12) can form a capillary action to draw the body fluid sample.
5. A body fluid sample collection device according to claim 3, wherein the collection tube (12) is integral with the handle (11), or
The collection tube (12) and the handle (11) are configured to be connected to each other in a nested manner.
6. A body fluid sample collection device comprising a collection stick (10) and a main tube (20), the collection stick (10) being for collecting a body fluid sample, the main tube (20) being for diluting the body fluid sample collected by the collection stick (10), wherein,
the main pipe (20) is cylindrical, the main pipe (20) comprises a first cavity (21) and a second cavity (22), the collecting rod (10) can extend from the first cavity (21) to the second cavity (22),
the second chamber (22) contains a diluent, the end of the second chamber (22) remote from the first chamber (21) is provided with a pierceable end seal (20 s 1),
the body fluid sample sampling device also comprises a tubular detection box (30), the inner cavity of the detection box (30) is provided with a puncturing device (331) which can puncture the end sealing piece (20 s 1), the inner cavity of the detection box (30) is also provided with a detection device (31), the detection device (31) comprises a test paper (311) and a reagent bearing device (312), the main pipe (20) can extend into the inner cavity of the detection box (30) so as to puncture the end sealing piece (20 s 1) and enable the diluted body fluid sample to flow to the detection device (31),
the collecting rod (10) comprises a collecting tube (12), the collecting tube (12) can absorb the body fluid sample by utilizing capillary action, the collecting tube (12) can at least partially extend into the second cavity (22), the collecting tube (12) comprises an inner column (121) and an outer sleeve (122), the inner column (121) is of a solid structure, the outer sleeve (122) is of a hollow tubular structure, the outer sleeve (122) can be sleeved at the end part of the inner column (121) and forms a gap which is communicated with the inner column (121) in the axial direction of the outer sleeve (122) so that the collecting tube (12) can form capillary action to absorb the body fluid sample,
the acquisition rod (10) comprises a first acquisition rod and a second acquisition rod,
the first collection stick is used for sealing the first cavity (21) and the second cavity (22) from each other when the body fluid sample is not introduced into the main pipe (20),
the second collection stick is used for collecting the body fluid sample and replacing the first collection stick when the body fluid sample is introduced into the main pipe (20).
7. The body fluid sample collection device according to claim 6, wherein the second collection wand comprises a handle (11) and the collection tube (12),
the handle (11) can be tightly matched with the main pipe (20) at the end part of the first cavity (21) far away from the second cavity (22),
the collecting tube (12) is connected with the handle (11);
the primary collection stick includes the handle (11) and does not include the collection tube (12).
8. The device according to claim 1 or 6, wherein the cartridge (30) comprises a stopper (32) and a cartridge (33),
the box sleeve (33) is cylindrical, is open at one end and closed at the other end, the box sleeve (33) is made of transparent materials,
the clamping plug (32) is accommodated in the inner cavity of the box sleeve (33), and the clamping plug (32) is used for fixing the detection device (31).
9. The body fluid sample collection device according to claim 1 or 6, further comprising a pressing member (40), said pressing member (40) being capable of being pressed against an end of the collection stick (10) fitted to the main tube (20) to fit the main tube (20) and the cartridge (30) in place.
10. The body fluid sample collection device according to any one of claims 1 to 9, wherein the body fluid sample collection device is for collecting a blood sample.
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