CN111380724A

CN111380724A - Body fluid sample collecting and inspecting device

Info

Publication number: CN111380724A
Application number: CN202010331910.3A
Authority: CN
Inventors: 万志强; 李泽江; 贾文刚
Original assignee: WHPM Bioresearch and Technology Co Ltd
Current assignee: WHPM Bioresearch and Technology Co Ltd
Priority date: 2020-04-24
Filing date: 2020-04-24
Publication date: 2020-07-07
Anticipated expiration: 2040-04-24
Also published as: CN111380724B

Abstract

The invention provides a body fluid sample collection device, which comprises a collection rod (10) and a main pipe (20), wherein the collection 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 collection rod (10), the main pipe (20) is cylindrical, the main pipe (20) comprises a first cavity (21) and a second cavity (22), the collection rod (10) can extend from the first cavity (21) to the second cavity (22), the second cavity (22) contains a diluent, and the end part of the second cavity (22) far away from the first cavity (21) is provided with a puncture end sealing piece (20s 1). The body fluid sample collection and detection device has a reasonable structure, and can conveniently collect and detect a body fluid sample.

Description

Body fluid sample collecting and inspecting device

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 testing of body fluids such as blood, the functional integration of the existing collection and testing devices is not high, and rapid detection is difficult to achieve through simple operation.

Disclosure of Invention

It is an object of the present invention to overcome or at least alleviate the above-mentioned deficiencies of the prior art and to provide a body fluid sample collection device.

The invention provides a body fluid sample collection device, comprising 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, wherein,

the main tube is cylindrical and 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 diluent and the end of the second chamber remote from the first chamber is provided with a pierceable end seal.

In at least one embodiment, the first and second lumens are sealingly isolated from each other when the collection wand is extended from the first lumen into the second lumen and when the collection wand is installed in place with the main tube.

In at least one embodiment, an intermediate seal is disposed between the first and second chambers, which is pierceable by the collection rod, and sealingly isolates the first and second chambers from each other.

In at least one embodiment, the collection wand includes a handle and a collection tube,

the handle can mate with the main tube at the end of the first lumen distal from the second lumen,

the collection tube is coupled to the handle, the collection tube is capable of drawing the bodily 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 handle is provided with a vent in the area where the handle is attached to the collection tube, the vent being in communication with the collection tube such that the collection tube can create a capillary action to draw the bodily fluid sample.

In at least one embodiment, the collection tube comprises an inner post and an outer sheath,

the inner column is of a solid structure, the outer sleeve is of a hollow tubular structure,

the outer sleeve can be sleeved on the end part of the inner column, and a gap which is communicated in the axial direction of the outer sleeve is formed between the outer sleeve and the inner column, so that the collection tube can form capillary action to absorb 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 nestably connect with one another.

In at least one embodiment, the acquisition rods comprise a first acquisition rod and a second acquisition rod,

the first collection wand is for sealingly isolating the first lumen and the second lumen from each other when the bodily fluid sample is not introduced into the primary tube,

the second collection wand is for collecting the bodily fluid sample and replacing the first collection wand when introducing the bodily fluid sample into the primary tube.

In at least one embodiment, the second collection wand includes a handle and a collection tube,

the collection tube is connected to the handle, the collection tube is capable of absorbing the bodily fluid sample by capillary action, and the collection tube is capable of extending at least partially into the second cavity;

the first collection wand includes the handle and does not include the collection tube.

In at least one embodiment, the body fluid sample collection and inspection device further comprises a cartridge having a cylindrical shape,

the inner cavity of the detection box is provided with a puncture device which can puncture the end sealing element,

the inner cavity of the detection box is also provided with a detection device,

the main tube is capable of extending into the interior cavity of the test cassette to rupture the end seal and to allow the diluted body fluid sample to flow to the test 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 test cartridge comprises a cartridge plug and a cartridge sleeve,

the box sleeve is cylindrical, one end of the box sleeve is open, the other end of the box sleeve is closed, the box sleeve is made of transparent materials,

the blocking plug is accommodated in the inner cavity of the box sleeve and is used for fixing the detection device.

In at least one embodiment, the body fluid sample collection device further comprises a pressing member that can abut against an end of the collection rod 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 collection and detection device has a reasonable structure, and can conveniently collect and detect a body fluid sample.

Drawings

FIG. 1 is a sectional view of a body fluid sample testing device according to an embodiment of the present invention.

FIG. 2 is a schematic view of a collecting rod 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 configuration diagram of a main tube of the body fluid sample test device according to the first embodiment of the present invention.

FIG. 5 is a sectional view showing a collection rod and a main tube of a body fluid sample test device according to a first embodiment of the present invention assembled together.

Fig. 6 is a sectional view of a cartridge case of a body fluid sample test device according to a first embodiment of the present invention.

Fig. 7 is a partially cut-away schematic view of fig. 6.

Fig. 8 is a front view of fig. 6.

Fig. 9 is an exploded view schematically showing a card stopper of a body fluid sample test device according to a first embodiment of the present invention.

FIG. 10 is a cross-sectional view of the reagent carrier of FIG. 9.

Fig. 11 is a schematic view showing the cooperation of a pressing member of a body fluid sample test device according to a first embodiment of the present invention with a collection stick and a main tube.

FIG. 12 is a sectional view of a collecting rod of a body fluid sample testing device according to a second embodiment of the present invention.

FIG. 13 is a sectional view showing a collection rod and a main tube of a body fluid sample test device according to a third embodiment of the present invention assembled together.

FIG. 14 is a schematic view of a collecting rod of a body fluid sample testing device according to a fourth embodiment of the present invention.

Fig. 15 is an exploded schematic 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 sectional view of a main tube of a body fluid sample test device according to a fourth embodiment of the present invention.

FIG. 20 is a sectional view showing a body fluid sample testing device according to a fourth embodiment of the present invention, in which a collecting rod and a main tube are assembled together.

Description of reference numerals:

10 collecting rods; exhausting holes for 10 h;

11 a handle; 111 a first section of a handle; 112 a second handle section; 113a third section of handle; 113a connecting segment; 11f a flexible material; 11b a flange portion; 11c an engaging part;

12 a collection tube; 121 inner columns; 122 outer casings;

20 a main pipe; 20s1 end seals; 20s2 intermediate seal; 21a first chamber; 22a second chamber; 23, blocking; mesopores within 23 h; 231 a partition plate; 232 a sleeve; 2321 a first sleeve portion; 2322 a second sleeve portion;

30 a cartridge; 31a detection device;

311 test paper; 3111 a first zone; 3112 a second zone; 3113 a third zone; 3114 a fourth zone;

312 a reagent carrying device; 3121 coverslipping; 3122 a slide; 3123 dyeing the pad; 3124 a carrier layer; 3125 absorbent pad;

32, a plug is stuck; 321a bayonet head; 321a sealing part; 322 jamming the plug body; 322a main board; 322b side panels; a 32g card slot;

33, a box sleeve; 331a puncturing device; 331a drain; 332 a positioning bar;

40 pressing piece; s, sealing rings; and G, a gap.

Detailed Description

Exemplary embodiments of the present invention are described below with reference to the accompanying drawings. It should be understood that the detailed description is intended only to teach one skilled in the art how to practice the invention, and is not intended to be exhaustive or 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 to be sampled by the device is preferably, but not limited to, blood. It may also be saliva or urine, for example.

Unless otherwise specified, the radial direction in the present invention is coincident with the radial direction of collection tube 12, and the axial direction in the present invention is coincident with the axial direction of collection tube 12. The terms "upper" and "lower" herein refer to the illustrated orientation.

(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 cartridge 30, and a pressing member 40 (not shown in fig. 1). The collection wand 10 is used to collect a volume of a bodily fluid sample and transfer the bodily fluid sample into the main tube 20 for dilution. The acquisition rod 10 can be inserted into the main tube 20 and mated with the main tube 20. The main tube 20 is used to contain a diluent for diluting a body fluid sample, and the main tube 20 can be inserted into the cartridge 30 and tightly fitted to the cartridge 30. The cartridge 30 is configured to accommodate a detection device 31 (see fig. 9), and the cartridge 30 is configured to pierce the main tube 20 to allow the diluted body fluid sample dissolved therein to flow to the detection device 31. The pressing member 40 serves to help the collection rod 10 and the main tube 20, which are assembled together, be more completely inserted into the cartridge 30 and be tightly assembled with the cartridge 30.

Referring to fig. 2 and 3, a collecting rod 10 according to the present embodiment is described.

In this embodiment, collection wand 10 includes a handle 11 and a collection tube 12.

The handle 11 is for the operator to grasp, and the handle 11 can be fitted in a nested manner with the main tube 20 and the cartridge 30.

The handle 11 is a stepped cylindrical shape including a first handle section 111, a second handle section 112, and a third handle section 113. Wherein, the size of the first handle section 111 in the radial direction is larger than that of the second handle section 112 in the radial direction, and the size of the second handle section 112 in the radial direction is larger than that of the third handle section 113 in the radial direction. The second handle section 112 can be inserted into the first cavity 21 of the main tube 20 described below, and the first handle section 111 can be inserted into the inner cavity of the cartridge 30 described below. Handle third section 113 is adapted to be connected to collection tube 12.

Preferably, the outer peripheries of the first handle section 111 and the second handle section 112 are coated with a flexible material 11f to increase the tightness of the assembly and prevent the liquid from leaking when the handle 11 is assembled with the main tube 20 and the cartridge 30. Preferably, the flexible material 11f is soft gel, which is formed to the outer circumference of the handle first section 111 and the handle second section 112 through an over-molding process. Preferably, the flexible material 11f forms a ring-shaped protrusion at each of the first and

second handle sections

111 and 112 to enhance the sealing effect.

For convenience of the entire description, the third section 113 of the handle in the axial region indicated by the brace in fig. 3 is referred to as a connecting section 113 a. Connecting segment 113a is tubular and connects to collection tube 12. The collection tube 12 is in the form of a thin tube, the lumen of which is used to draw a sample of bodily fluid. In this embodiment, connecting segment 113a is integrally formed and seamlessly joined with collection tube 12.

The peripheral wall of the end of the connecting section 113a far away from the collecting tube 12 is provided with an air vent hole 10h, the air vent hole 10h is communicated with the inner cavity of the connecting section 113a, and the air vent hole 10h is also communicated with the inner cavity of the collecting tube 12. This allows air to pass axially through collection tube 12, and thus the bodily fluid sample can wick into and fill the lumen of collection tube 12 when the end of collection tube 12 distal to handle 11 contacts the bodily fluid sample.

Preferably, collection tube 12 is made of a transparent material so that an operator can easily view the amount of bodily fluid sample drawn by collection tube 12 as the bodily fluid sample rises down the lumen of collection tube 12. Preferably, the peripheral wall of the collection tube 12 is provided with a scale for indicating the amount of bodily fluid sample.

The outer periphery of the third handle segment 113 is formed with a radially outwardly projecting ring of flange 11b, the flange 11b being adapted to cooperate with the sleeve 232 described below to axially and sealingly isolate the first and

second sleeve portions

2321 and 2322.

Preferably, the outer periphery of third handle segment 113 is fitted with a sealing ring S, which is axially adjacent to the axial end face of flange portion 11b adjacent to collection tube 12. The exhaust hole 10h is not covered by the seal ring S at least partially. 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 assembled relationship with the harvesting rod 10 will be described.

The main pipe 20 is tubular, and in the present embodiment, the main pipe 20 has a substantially D-shaped cross section perpendicular to the axial direction.

The inner cavity of the main tube 20 has a baffle 23, which baffle 23 divides the inner cavity of the main tube 20 in two parts in the axial direction, namely a first cavity 21 and a second cavity 22.

The first chamber 21 is primarily intended to be secured to the second handle section 112 and the second chamber 22 is intended to receive a diluent for diluting the bodily fluid sample.

The end of second chamber 22 remote from first chamber 21 is closed by end seal 20s1, end seal 20s1 being pierceable by piercing means 331 described below to allow the diluted bodily fluid sample to flow from second chamber 22. Preferably, end seal 20s1 is an aluminum foil, and preferably, end seal 20s1 made of aluminum foil is connected to main tube 20 by a heat sealing process (i.e., main tube 20 and aluminum foil are heated and connected together), and the material of which main tube 20 is made is, for example, plastic.

The barrier 23, in addition to serving to separate the two chambers in the interior of the main tube 20, also serves to seal the second chamber 20. Such sealing includes sealing in the first instance when the acquisition rod 10 is not extended into the main tube 20 and in the second instance after the acquisition rod 10 is extended into the main tube 20.

The baffle 23 includes a partition 231 located at an outer peripheral portion and a sleeve 232 located 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 central hole 23h communicating the first chamber 21 and the second chamber 22.

The sleeve 232 includes two portions axially on either side of the diaphragm 231, with a first sleeve portion 2321 facing the first chamber 21 and a second sleeve portion 2322 facing the second chamber 22. The inner diameter of the first portion 2321 of the sleeve is slightly larger than the inner diameter of the central bore 23h, the inner diameter of the first portion 2321 of the sleeve is approximately equal to the outer diameter of the flange portion 11b of the acquisition rod 10, and the inner diameter of the second portion 2322 of the sleeve is approximately equal to the inner diameter of the central bore 23 h.

Referring to fig. 4, when the acquisition rod 10 is not inserted into the main tube 20, the end of the second sleeve portion 2322 is closed by the middle seal 20s 2. Preferably, the middle seal 20s2 is an aluminum foil, and preferably, the aluminum foil middle seal 20s2 is coupled to the sleeve second portion 2322 through a heat sealing process.

It will be appreciated that during production, one of end seal 20s1 and intermediate seal 20s2 (e.g., intermediate seal 20s2) is first sealed to primary tube 20, diluent is then added to second chamber 22, and finally, the other of end seal 20s1 and intermediate seal 20s2 (e.g., end seal 20s1) is sealed. Thus, the diluent is loaded in the second chamber 22 and does not leak from the main pipe 20 without the end seal 20s1 and the middle seal 20s2 being punctured.

Referring to fig. 5, when collection wand 10 extends from first lumen 21 into main tube 20, the end of collection tube 12 (which is preferably relatively sharp) can puncture middle seal 20s2 to extend further into second lumen 22 and into contact with the diluent. When the collection tube 12 comes into contact with the diluent, the bodily fluid sample contained within the collection tube 12 dissolves into the diluent as the operator shakes the main tube 20.

When the acquisition rod 10 and the main pipe 20 are assembled in place, the sealing ring S is compressed in the axial direction by the flange part 11b and the partition 231 located in the inner cavity of the first sleeve part 2321, respectively, so as to seal the second cavity 22; preferably, the outer diameter of the seal ring S is slightly larger than the inner diameter of the sleeve first portion 2321. Meanwhile, the step between the first handle section 111 and the second handle section 112 butts against the end of the main pipe 20 close to the first cavity 21, and the second handle section 112 is connected with the inner peripheral wall of the first cavity 21 in an interference fit manner.

In use, the assembled collection wand 10 and main tube 20 are further loaded into a test cassette 30, allowing the diluted bodily fluid sample to flow to a test device 31 located within the test cassette 30.

Next, the cartridge 30 according to the present invention will be described with reference to FIGS. 6 to 10.

The cartridge 30 includes a cartridge case 33, a card stopper 32, and a detection device 31. The card 32 and the detecting device 31 are installed inside the cartridge case 33, and the card 32 is used to fix the detecting device 31.

First, the cartridge 33 will be described with reference to fig. 6 to 8.

The case 33 has a cylindrical shape (or a box shape) with one open end and one closed end, and the open end is used for the main pipe 20 to extend into.

The bottom of the inner cavity of the cartridge 33 is provided with a puncturing means 331, the puncturing means 331 being adapted to puncture the end seal 20s1 of the main tube 20. Preferably, referring to fig. 7 and 8, the puncturing device 331 has a trapezoidal shape with a small upper portion and a large lower portion in order to allow sufficient sample diluent to flow into the cartridge 33 after the end seal 20s1 is punctured.

Preferably, to guide the sample diluent out, the platform-like puncturing device 331 is formed with a plurality of axially extending channels. And more preferably, the middle portion of the puncturing means 331 forms a hollow cylindrical cavity having one sidewall opened to define a drain portion 331a, the drain portion 331a facing the card plug 32 described later, to drain the sample diluent to the detecting means 31 mounted to the card plug 32.

Two opposite side wall portions in the inner cavity of the cartridge 33 are convexly formed with wedge-shaped positioning strips 332 small in top and large in bottom, the positioning strips 332 being used to cooperate with the below-described click plug 32 to position the click plug 32.

Next, the jam 32 and the detection device 31 will be described with reference to fig. 9 and 10.

Referring to fig. 9, the card plug 32 includes a plug head 321 and a plug body 322. The blocking head 321 is tubular, and the main tube 20 can pass through the blocking head 321. The outer circumferential wall of the bayonet head 321 is adapted to cooperate with the inner circumferential wall of the sleeve 33, and the inner circumferential wall of the bayonet head 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 periphery of the bayonet head 321 is provided with an annular sealing portion 321a made of a flexible material for forming a seal with the cartridge case 33.

The body 322 is plate-shaped and is used to accommodate the detecting device 31, and the body 322 can also be positioned to fit with the side wall of the casing 33.

Specifically, the card plug body 322 includes a main plate 322a and two side plates 322b located at two sides of the main plate 322a and arranged perpendicular to the main plate 322 a. The side plate 322b is wedge-shaped with a smaller bottom and a larger top to cooperate with the positioning strip 332 for positioning.

The main board 322a has a plurality of recessed slots 32g formed on the surface thereof for abutting against the casing 33 to receive the detecting device 31.

In the present embodiment, the detection device 31 includes a test strip 311 and a reagent carrying device 312.

The test strip 311 is, for example, a colloidal gold immunochromatographic test strip, and includes, for example, a first zone 3111, a second zone 3112, a third zone 3113, and a fourth zone 3114 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 bibulous pad. In the third region 3113, a reaction line (T line) and a control line (C line) are provided. When the test strip 311 is attached to the body 322, the first zone 3111 faces downward (away from the stopper head 321).

Referring to fig. 10, the reagent carrier 312 is, for example, a combination of cover slides. The multifunctional cover glass comprises a cover glass 3121, a glass slide 3122, a staining pad 3123, a carrier layer 3124 and a water absorption pad 3125, wherein the staining pad 3123, the carrier layer 3124 and the water absorption pad 3125 are sandwiched between the cover glass 3121 and the glass slide 3122.

The staining pad 3123 is made of a water absorbent material for absorbing cells in the sample reagent and staining the cells. Preferably, the staining pad 3123 is partially exposed from the cover glass 3121 and the slide 3122.

A carrier layer 3124 is disposed adjacent to the staining pad 3123 and is completely contained between the cover glass 3121 and the slide glass 3122, the carrier layer 3124 is made of a water absorbing material (e.g., one or more of nitrocellulose membrane, non-woven fabric, blood filtering membrane, and cellophane).

An absorbent pad 3125 is disposed on an end of the carrier layer 3124 distal from the dye pad 3123 for absorbing excess liquid.

When the reagent carrier 312 is mounted to the card body 322, the staining pad 3123 faces downward and the cover glass 3121 faces outward.

It should be understood that the cover glass 3121 and the slide 3122 may also be replaced by a transparent plastic sheet.

In particular, since the transparent wall of the cassette housing 33 is in close contact with the reagent holding device 312 or is spaced from the reagent holding device 312 only by a small distance, the cover glass 3121 may be omitted, and the wall of the cassette housing 33 may function as the cover glass 3121.

It should be understood that in this embodiment, there are two test strips 311 and two reagent carriers 312, which can be used to provide a backup for the reliability of the detection. However, the number of the test strips 311 and the reagent carriers 312 may be set as required, and the present invention is not limited thereto.

Referring to fig. 11, it is preferable that the body fluid sample collection device according to the present invention 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 to fully extend into the interior of the testing box 30, so as to ensure the sealing performance of the whole device. For example, the first handle section 111 and the second handle section 112 have cavities therein, and the pressing member 40 can extend to 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 acquisition rod 10, the main tube 20, and the cartridge 30 are not assembled together before being used by an operator. At this time, the main tube 20 contains the diluent, and the detecting unit 31, the stopper 32 and the cartridge case 33 are assembled together to form the detecting cartridge 30.

In use, the operator first draws a sufficient volume of a body fluid sample using the collection wand 10.

Thereafter, with the collection rod 10 extending from the first chamber 21 into the second chamber 22 of the main tube 20, the collection rod 10 will rupture the middle seal 20s 2. After the collection wand 10 is contacted with the diluent, the body fluid sample is mixed with the diluent by shaking. In addition, after the collection rod 10 and the main pipe 20 are assembled in place, the second chamber 22 is sealed and the internal liquid does not leak.

Thereafter, the assembled collection rod 10 and main tube 20 are inserted into the test cassette 30, the end seal 20s1 is punctured by the puncturing means 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 rod 10 and the main tube 20 integrally with the cartridge 30 may be performed by means of the pressing member 40. After the whole body formed by the collection rod 10 and the main tube 20 is assembled with the detection box 30 in place, the open end of the detection box 30 is sealed, and the internal liquid does not leak.

After that, the operator can know the detection result by observing the detection device 31. For example, the color development result of the test strip 311 is directly observed, and/or the body fluid specimen collecting device is placed on the placement area of the microscope for observation.

It should be understood that the pressing member 40 may be press-fitted to the harvesting rod 10 when the collection rod 10 and the main tube 20 are integrally assembled with the cartridge 30, or may be pre-installed at the end of the harvesting rod 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 parts as those of the first embodiment is omitted.

In this embodiment, the handle 11 of the collection wand 10 and the collection tube 12 are manufactured separately and then assembled together.

The connecting section 113a of the lower end of the handle third section 113 of the handle 11 has a tubular shape. The collection tube 12 can be nested within the lumen of the connecting section 113a such that the collection tube 12 and the handle 11 are connected together. The outer diameter of collection tube 12 is equal to or slightly larger than the inner diameter of connecting segment 113 a.

(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 embodiment and the second embodiment, and the description of the same parts as those of the second embodiment is omitted.

In this embodiment, a set of bodily fluid sample collection devices includes two collection sticks. One collection wand, which is the same as the collection wand of the first or second embodiment, is used to obtain a bodily fluid sample; another collection wand, shown in fig. 13, acts as an in-line lid for the primary tube 20, sealing the second chamber 22 in place of the mid-seal 20s2 of the first embodiment, before the primary tube 20 is opened to dilute the bodily fluid sample.

In order to simplify the manufacturing process and reduce the manufacturing cost, the collecting rod for obtaining the body fluid sample has the same structure as the collecting rod in the second embodiment; while the collection wand 10 described above for sealing the second chamber 22 has only the handle 11 of the collection wand of the second embodiment and no collection tube 12.

The main pipe 20 in the present embodiment does not have an intermediate seal.

Before use, the collecting rod 10 for sealing the second chamber 22 is assembled with the main tube 20, and the second chamber 22 contains the diluent.

In use, the operator removes the collection stick 10 of fig. 13 and inserts the collection stick, which has collected a bodily fluid sample, into the main tube 20.

The arrangement mode omits the process of puncturing the middle sealing piece by the collecting pipe in the first embodiment, the collecting rod is not easy to be damaged, and foreign matters possibly stained on the middle sealing piece are not easy to be introduced into the diluent in the diluting process.

(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 parts as those of the first embodiment is omitted.

Referring to fig. 14-18, in this embodiment, collection tube 12, rather than being formed as a hollow tube, includes an inner post 121 and an outer sleeve 122 nested within one another.

The inner post 121 is a solid cylindrical shape, and preferably, the end of the inner post 121 is sharp.

The outer sleeve 122 is tubular, and the outer sleeve 122 is sleeved on the periphery of the inner column 121. The outer sleeve 122 is secured to the inner post 121, for example, by a snap fit. Preferably, the end of the outer jacket 122 is formed in a relatively sharp shape.

The outer sleeve 122 has an inner diameter slightly larger than the outer diameter of the inner column 121 so that a gap is left between the inner column 121 and the outer sleeve 122 and the gap is continuous in the axial direction, for example, a gap G (see fig. 18) is left between the end of the outer sleeve 122 facing the handle 11 and the inner column 121 in the axial direction.

Thus, the annular gap between the inner post 121 and the outer sheath 122 provides a capillary channel for the bodily fluid sample.

In the present embodiment, the mating portion of the handle 11 and the main tube 20 is also modified. The handle 11 has an engaging portion 11c, and the engaging portion 11c has a substantially rectangular parallelepiped shape. Accordingly, referring to fig. 19 and 20, the sleeve first portion 2321 inside the main tube 20 is also formed in a square cylindrical shape so as to be able to be fitted closely to the engagement portion 11 c.

The collection tube 12 according to this embodiment is structurally strong and 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 suitably combined.

The invention has at least one of the following advantages:

(i) the body fluid sample acquisition, dilution and detection device is integrated in a sleeved mode, and the body fluid sample acquisition and detection device can be used for conveniently and rapidly completing the acquisition and detection of samples.

(ii) The body fluid sample collecting device according to the present invention includes, for example, a test paper 311 and a reagent carrying device 312, and facilitates quick observation of the detection result. In particular, the operator may directly place the body fluid sample collection device in a microscope and view the reagent carrier 312 through the wall of the device.

(iii) The body fluid sample collecting and detecting device has good sealing performance, foreign matters are not easy to introduce in the detecting process, and the detecting result is reliable.

Of course, the present invention is not limited to the above-described embodiments, and those skilled in the art can make various modifications to the above-described embodiments of the present invention without departing from the scope of the present invention under the teaching of the present invention. For example:

(i) the body fluid sample collection device according to the present invention may not have the pressing member 40, but may be assembled by manually pressing the handle with another tool or by an operator.

(ii) The body fluid sample collection and inspection device according to the present invention can be used for direct observation or observation by means of other devices when an operator performs inspection.

Claims

1. A body fluid sample collection device comprising a collection wand (10) for collecting a body fluid sample and a main tube (20) for diluting the body fluid sample collected by the collection wand (10), wherein,

the main tube (20) is cylindrical, the main tube (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, and the end of the second chamber (22) remote from the first chamber (21) is provided with a pierceable end seal (20s 1).

2. A body fluid sample collection device according to claim 1, wherein said first (21) and second (22) chambers are sealingly isolated from each other when said collection wand (10) is extended from said first (21) into said second (22) chamber and when said collection wand (10) and said main tube (20) are in place.

3. A body fluid sample collection device according to claim 1, wherein a middle seal (20s2) is provided between said first (21) and second (22) chambers, which can be punctured by said collection rod (10), said middle seal (20s2) sealingly isolating said first (21) and second (22) chambers from each other.

4. A body fluid sample collection device according to claim 1, wherein said collection wand (10) comprises a handle (11) and a collection tube (12),

the handle (11) can be tightly fitted with the main tube (20) at the end of the first cavity (21) remote from the second cavity (22),

the collection tube (12) is connected to the handle (11), the collection tube (12) is capable of drawing the bodily fluid sample by capillary action, and the collection tube (12) is capable of extending at least partially into the second cavity (22).

5. A body fluid sample collection device according to claim 4, wherein said collection tube (12) is tubular and the handle (11) is provided with a vent (10h) in the region where it is connected to said collection tube (12), said vent (10h) being in communication with said collection tube (12) so that said collection tube (12) can create a capillary action to draw said body fluid sample.

6. A body fluid sample collection device according to claim 4, wherein said collection tube (12) comprises an inner post (121) and an outer sheath (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 on the end part of the inner column (121), and a gap which is communicated in the axial direction of the outer sleeve (122) is formed between the outer sleeve (122) and the inner column (121), so that the collection tube (12) can form capillary action to suck the body fluid sample.

7. A body fluid sample collection device according to claim 4, wherein said collection tube (12) is integral with said handle (11) or

The collection tube (12) and the handle (11) are configured to nestably connect with one another.

8. The body fluid sample collection device according to claim 1, wherein said collection wand (10) comprises a first collection wand and a second collection wand,

the first collection rod is used for hermetically isolating the first cavity (21) and the second cavity (22) from each other when the body fluid sample is not introduced into the main tube (20),

the second collection wand is used to collect the bodily fluid sample and replace the first collection wand when introducing the bodily fluid sample into the main tube (20).

9. A body fluid sample collection device according to claim 8, wherein said second collection wand comprises a handle (11) and a collection tube (12),

said collection tube (12) being connected to said handle (11), said collection tube (12) being capable of absorbing said body fluid sample by capillary action, and said collection tube (12) being capable of extending at least partially into said second cavity (22);

the first collection wand includes the handle (11) and does not include the collection tube (12).

10. The body fluid sample collection device according to any one of claims 1 to 9, further comprising a cartridge (30) having a cylindrical shape,

the inner cavity of the detection box (30) is provided with a puncturing device (331) which can puncture the end sealing piece (20s1),

the inner cavity of the detection box (30) is also provided with a detection device (31),

the main tube (20) is capable of extending into the interior cavity of the test cassette (30) to cause the end seal (20s1) to be ruptured and the diluted body fluid sample to flow to the test device (31).

11. A body fluid sample collection device according to claim 10, wherein said detection means (31) comprises a test strip (311) and/or a reagent carrying means (312).

12. The body fluid sample collection device according to claim 10, wherein said detection cartridge (30) comprises a cartridge holder (32) and a cartridge cover (33),

the box sleeve (33) is cylindrical, one end of the box sleeve is open, the other end of the box sleeve is closed, the box sleeve (33) is made of transparent materials,

the blocking plug (32) is accommodated in the inner cavity of the box sleeve (33), and the blocking plug (32) is used for fixing the detection device (31).

13. The body fluid sample collection device according to claim 10, further comprising a pressing member (40), wherein the pressing member (40) can abut against an end of the collection rod (10) fitted to the main tube (20) to fit the main tube (20) to the cartridge (30).

14. A body fluid sample collection device according to any one of claims 11 to 13, wherein said body fluid sample collection device is used for collecting a blood sample.