CN108968982A - The detection device of analyte in sample - Google Patents
The detection device of analyte in sample Download PDFInfo
- Publication number
- CN108968982A CN108968982A CN201810578554.8A CN201810578554A CN108968982A CN 108968982 A CN108968982 A CN 108968982A CN 201810578554 A CN201810578554 A CN 201810578554A CN 108968982 A CN108968982 A CN 108968982A
- Authority
- CN
- China
- Prior art keywords
- detection device
- sample
- solution storage
- analyte
- piercing element
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
-
- 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
Abstract
The present invention provides a kind of detection device of analyte in sample, which includes solution storage, piercing element and sense channel;When solution storage is located at first position with respect to piercing element, there is distance between solution storage and piercing element;When solution storage is located at the second position with respect to piercing element, piercing element opens solution storage;Sense channel includes the carrier for accepting solution and the test department for placing test-strips, and carrier is connected to test department;Piercing element is located at carrier.Using the device of the invention, blood sampling is allowed, buffer solution, detection device is structure as a whole, and the collection and detection of blood sample can be completed with a step.
Description
Technical field
The present invention relates to a kind of detection devices of analyte in sample, particularly, belong to quilt in detection blood sample
Analyze the device of substance.
Background technique
Following background technique is used to help reader and understands the present invention, and is not construed as the prior art.
Blood is always detection field through common sample, because containing many Biological indicators or being analyzed in blood
Substance.In the field POCT, if necessary to carry out the detection of analyte to blood, it is typically necessary the receipts for carrying out blood
Collection, such as with the capillary on blood-taking needle broken skin skin, the acquisition of blood sample is carried out with blood sampling tool, then carries out blood
The analysis of sample.Generally when individual carries out blood sample detection, blood taking needle is needed, take a blood sample tool and detection device,
It usually can also be with the solution reagent of processing blood.These general apparatus are all packed in together, not only bad for packaging, and
And when use, the trouble used, or the damage to human body will cause.
This is improved with regard to the device in need to traditional detection blood sample, with the defect more than overcoming, allows use
Person is more convenient and convenient.
Summary of the invention
In order to solve the problems in the existing technology, the present invention provide analyte in a kind of detection fluid sample,
The detection device of analyte especially in blood sample.
The detection device of analyte in a kind of sample, it is characterised in that: the detection device includes solution storage, is worn
Pierce element and sense channel;When solution storage is located at first position with respect to piercing element, solution storage and piercing element it
Between have distance;When solution storage is located at the second position with respect to piercing element, piercing element opens solution storage release solution;
Sense channel includes liquid collecting portion and test department, and liquid collecting portion is connected to test department;Piercing element is located in sense channel.
Liquid collecting portion is used to collect the solution discharged from solution storage, and test department is for placing testing element (such as test paper
Item).
Solution storage is except sense channel, and solution storage with respect to piercing element at first position, store by solution
It is not in contact with each other between device and piercing element, solution is sealed in solution storage;External force makes solution storage and punctures member
When the relative position of part is the second position, piercing element opens solution storage, and solution enters liquid collecting portion, and testing element is (such as
Test strips) absorb liquid collecting portion solution, show testing result.
Piercing element
Piercing element is used to open the opening of solution storage, thus the solution in release solution storage.
As a preferred option, piercing element face solution storage, piercing element diversion trench have sword or tip.
Solution storage is opened in puncture portion in a manner of puncturing film, and diversion trench realizes solution release.A kind of scheme, preferably
, tip end surface is equipped with diversion trench.The cross section of diversion trench is semicircle, rectangle, V-arrangement or L shape etc.;The quantity of diversion trench can be with
Be 1 be also possible to it is multiple.Preferably, puncture portion is in cone.
Another scheme: preferred, piercing element is made of multiple sub-portions, and all sub-portions surround cylinder, adjacent sub-sections it
Between have a gap, each sub-portion has blade, and the gap between sub-portion is as diversion trench.Alternatively, piercing element is in cylinder or circular cone
Body, piercing element is interior to be equipped with open-topped channel, and puncture channel is equipped with the liquid-passing hole or logical liquid bath that channel is in communication with the outside,
The opening in channel has sword.Sword is as puncture portion, channel and liquid-passing hole or logical liquid bath as diversion trench.When the sword of piercing element connects
When contacting film, sword punctures film, liquid inlet channel, and reaches liquid collecting portion through liquid-passing hole or logical liquid bath.
Movable member
When solution storage or piercing element are mounted on movable member, when movable member is displaced, so that solution storage and wearing
Pierce element relative displacement, thus realize solution from be sealed to release.
As a preferred option, detection device has the movable member that can be displaced, and movable member includes press section and displacement portion,
Piercing element or solution storage are fixed on movable member.
Preferably, displacement portion is sleeve, has the guide post cooperated with sleeve in detection device;The first end and pressing of sleeve
Portion is fixed, and the second end and guide post of sleeve cooperate.When initial, sleeve is placed on guide post, as sleeve is moved along guide post, solution
Storage and piercing element are close to each other.
Alternatively, displacement portion is guide post, there is the sleeve cooperated with guide post in detection device;The first end of guide post and press section
Fixed, the second end and sleeve of guide post cooperate.When initial, guide post is placed on sleeve, and guide post is moved along sleeve stores solution
Device and piercing element are close to each other.
As a preferred option, have in detection device and be inserted into movable with the matched movable member window of movable member, movable member
In part window.
Solution storage
Solution storage is the device for storing solution reagent.As a preferred option, solution storage includes having
The cavity of opening and the sealing element of sealed opening.Preferably, sealing element be be easy to be punctured and the material of waterproof made of it is thin
Film, such as plastic film.As a preferred option, the cavity of solution memory is surrounded by bottom plate and side wall, is opened at the top of cavity
Mouthful, it is open by diaphragm seal.
Hemostix
Hemostix is used to collect sample, such as blood sample.
As a preferred option, detection device is equipped with hemostix.Preferably, it includes adopting that hemostix, which is tubular structure hemostix,
Orgnaizer of illegal blood donation collects blood sample using the blood sampling head.Preferably, hemostix one end connection blood sampling head, the other end is blood sampling pipet, is adopted
Orgnaizer of illegal blood donation is air bag.Preferably, have on detection means and allow the mounting portion of the detachable assembly of hemostix.Preferably, mounting portion
It is affixed to the sleeve of detection device, sleeve is open at one end.Hemostix is out of opening insertion sleeve.Alternatively, mounting portion is fixed
In the elastic buckles of detection device, elastic buckles have the bayonet for allowing hemostix to enter.Hemostix is caught in elastic buckles from opening.
Puncture device
Puncturing device is for scratching skin or tissue to discharge the device of blood.Puncturing device is commonly to puncture mechanism,
Such as disposable safe blood-taking needle, generally puncturing device includes a sharp needle, is used to penetrating tissue bloodletting.Disposable safety
Blood taking needle is after needle transmitting, and needle core will be lockable, so that blood taking needle is used only once, it is ensured that the safety of user.
As a preferred option, detection device, which has, accommodates penetrating tissue and punctures device, and it is exposed to puncture device one end, punctures device
Exposed junction contain lancet.Lancet is used to penetrating tissue to discharge blood.As a preferred option, puncturing device includes card
It is connected to the ontology of detection device and accommodates the appearance needle cavity of needle, hold needle cavity and expose to detection device.
Testing element and sense channel
As a preferred option, detection device further includes testing element.It can detecte in blood sample by testing element
The presence or quantity of analyte.Preferably, testing element includes imbibition end, sample application zone and reagent test area, is inhaled
Liquid end is communicated with the liquid collecting portion of sense channel, the solution of draw solution storage release.Adding in the corresponding housing of sample application zone
Sample window, actual test area correspond to display window.
As a preferred option, sense channel be equipped with card slot element, testing element it is detachable be installed on card slot element
It is interior.Preferably, lower plate has bracket, and bracket is located in sense channel, and testing element is placed on bracket.Bracket is by testing element frame
It rises, avoids solution Soak Test element.
The shell of detection device
Shell provides accommodation space to puncture device, solution storage and sense channel.
As a preferred option, detection device has shell, have solution storage, piercing element in shell, puncture device and
Testing element punctures device, solution storage and piercing element and is integrated in shell, it is exposed to puncture device one end.Preferably, solution is stored
Device or piercing element are installed on movable member, and movable member, solution storage and piercing element are located at the first area of shell, the firstth area
Domain has the space of movable member displacement., it is preferred that testing element includes at least imbibition area, sample application zone and results display area, test
The imbibition area of element is located at first area, and the part other than the imbibition area of testing element and sample application zone is located at the secondth area of shell
Domain, installation space needed for second area has testing element.The liquid collecting portion of sense channel is located at first area, sense channel
Test position is in second area.Solution reaches liquid collecting portion after being released, and after testing element absorbent solution, solution passes through sample application
Sample is dissolved in area, sample reaches reagent test area through capillary action, reacted with reagent after show result.
First area meets the running space of movable member;Second area meets the installation space of testing element.First area
Need to meet space requirement of the movable member from first position to the second position, the height of second area only needs that test member can be accommodated
Part and bracket.Second area accommodates mounted testing element, the freedom degree of testing element upper and lower, left and right quilt just
Limitation, therefore the position of testing element is stablized, and guarantees the accuracy rate of detection.Preferably, lower plate is plate, the first area of upper plate
Pass through chamfered transition with second area.
Preferably, the end that device is located at shell is punctured.Preferably, it punctures device and is located at first area.It punctures device and is located at end,
Use when facilitating blood sampling.
Preferably, shell be equipped with movable member window, the display window of testing result and allow to puncture device loading puncture device
Window.Preferably, shell includes upper plate and lower plate, and movable member window and display window are set to upper plate, and sense channel is set to lower plate;
When piercing element is set to movable member, solution storage be set to lower plate, when solution storage is set to movable member, piercing element is set to down
Plate.
As a preferred option, upper plate is equipped with the sample-adding window of sample application, and sample-adding window is located at movable member window and shows
Show between window.
As a preferred option, it punctures device window set on upper plate, or punctures device window by the notch and lower plate of upper plate
Notch is combined into.
Anti-misoperation lid
As a preferred option, detection device includes shell, is equipped with the movable member being flexibly connected in shell, shell is equipped with
Cover the anti-misoperation lid of movable member.Preferably, anti-misoperation lid covers movable member window, and anti-misoperation lid has rib, gear
While movable member window is trapped among in it.Anti-misoperation lid is that movable member is avoided to run and cause the one of product failure because of maloperation
Kind safeguard measure.Preferably, anti-misoperation lid is rotatably connected at shell.Preferably, between anti-misoperation lid and shell by
Rotating connector connection, rotating connector includes connecting rod, and connecting rod one end is connect with anti-misoperation lid, and the other end and shell connect
It connects.Preferably, connecting rod is respectively set in the two sides of shell, and connecting rod one end and shell are fixed, the other end and anti-misoperation lid turn
Dynamic connection, alternatively, connecting rod one end is connect with housing into rotation, the other end and anti-misoperation lid are fixed.
On the other hand, the present invention provides a kind of method for detecting analyte in blood sample, this method comprises: providing
Detection device, the detection device include testing element, and solution storage can puncture the piercing element of storage, wherein solution
Storage has the first fixed position and the second position in detection device;Solution storage is allowed to be moved to second from first position
Position;In the process of moving, puncturing elements are allowed to puncture solution storage, thus the solution in release solution storage.
Beneficial effect
Using the device of the invention, blood sampling is allowed, buffer solution, detection device is structure as a whole, and can complete blood with a step
The collection and detection of sample.
Detailed description of the invention
Fig. 1 is the exploded perspective structural schematic diagram of detection device in one embodiment of the present of invention.
Fig. 2 is the main view direction detonation configuration figure of the detection device of Fig. 1 of the present invention.
Fig. 3 is the assembling view of the detection device of Fig. 1 of the present invention.
Fig. 4 is the exploded perspective structural representation of the detection device in one embodiment of the present of invention with anti-misoperation lid
Figure.
Fig. 5 is the main view direction configuration schematic diagram of the detection device with anti-misoperation lid of Fig. 4 of the present invention.
Fig. 6 is the assembling view of the detection device with anti-misoperation lid of Fig. 4 of the present invention.
Fig. 7 is the exploded perspective structural schematic diagram in one embodiment of the present of invention with the detection device for puncturing device.
Fig. 8 is the main view direction configuration schematic diagram with the detection device for puncturing device of Fig. 7 of the present invention.
Fig. 9 is the assembling view with the detection device for puncturing device of Fig. 7 of the present invention.
Figure 10 is the schematic perspective view of the upper plate of one embodiment of the invention.
Figure 11 is the schematic perspective view of anti-misoperation lid in one embodiment of the invention.
Figure 12 is the schematic perspective view of the movable member of one embodiment of the invention.
Figure 13 is the schematic perspective view of the lower plate of one embodiment of the invention.
Figure 14 is the schematic perspective view of the piercing element of one embodiment of the invention.
Figure 15 is the schematic diagram of the testing element of one embodiment of the invention.
It is described in detail
Structure of the present invention or technical term used in these are described further below.These explanations are only
Be only using example way be illustrated it is of the invention by the way of how to realize, any limit can not be constituted to the present invention
System.
Detection
Detection indicates chemical examination or tests a kind of substance or material to whether there is, such as chemical substance, organic compound, inorganic
Compound, metabolism product, drug or drug metabolite, the metabolin of organic organization or organic organization, nucleic acid, protein
Or polymer, but it is not limited to this.In addition, detection indicates the quantity of test substances or material.Furtherly, chemical examination, which is also represented by, exempts from
Epidemic disease detection, chemical detection, enzyme detection etc..
Testing element
A variety of testing elements can be with combined application into the present invention.Testing element includes testing element 80, analysis test member
Part can there are many forms, for example, by using immune or test chemical form, for the analyte in test sample, such as poison
Product or the correlative metabolites for indicating physical condition.In some forms, testing element is with sample application zone, reagent area and detection knot
The water-absorbing material in fruit area.Sample is added to sample application zone, flows into reagent area using capillarity.In reagent area, sample dissolution
Reagent simultaneously mixed can be used for detecting analyte (if there are analytes in sample).At this time with reagent sample after
It is continuous to flow to test results zone.Other reagent is fixed on test results zone.These are fixed on the reagent of test results zone
It is reacted and is combined with analyte (if present) or with the first reagent of reagent area.In noncompetitive test format
In, if there are analytes will generate signal in sample, if analyte is not present, do not generate signal.It is competing
In test format, signal is generated if analyte is not present in sample, does not generate signal if if there is analyte.This
Invention is suitable for various analytical forms.
When testing element is testing element, it can be made of water suction or unwetted property material, a testing element
Multiple material can be used, the transmitting for liquid.A kind of material of testing element can be superimposed upon another testing element material
On material, for example, filter paper overlaid is on nitrocellulose.Alternatively, at least a region containing a kind of material is located in testing element
After a kind of another at least region containing different materials.In this case, liquid is circulation between each region, they
Between can be overlapped mutually or be not superimposed.Material on testing element can be fixed on such as support of plastics liner or
Person's hard surface, can holding force to reinforce testing element.
It (such as at least one enzyme and is detected in the embodiment that some detected materials are detected by signal generation system
Specific reaction occurs for object), at least one substance for generating signal can be attracted to the test results zone of testing element, as
It is specifically adsorbed on the material of testing element described in upper the same.Additionally, there are in the sample application zone of testing element, reagent area,
Test results zone, or the substance of the generation signal throughout entire testing element can pre-process one in testing element in advance
Or on multiple materials.It can be by the way that the substance solution for generating signal to be added to the surface of application area or by one of testing element
Or multiple materials are immersed in signal solutions and realize.It, will after testing element joined signal solutions or impregnate in the solution
Testing element drying.In addition, above method is present in the sample application zone, reagent area, test results zone of testing element, or spread
The substance of the generation signal of entire testing element can be pre-processed in advance on one or more materials of testing element.In addition, depositing
It is that the semiochemicals of testing element sample application zone, reagent area or test results zone can be added to testing element as labelled reagent
One or more surfaces of material.
As shown in figure 15, testing element 80 includes at least the following region liquid absorption area 801 being arranged successively, sample application zone
802, at least one test results zone 803.If test results zone 803 includes a control zone 804, preferably control zone 804
After the analyte detection zone of test results zone 803.It all these areas or combinations thereof can be in the list for containing a kind of material
In one test strips.In addition, these areas are made from a variety of materials, and link together by the direction that liquid transmits.For example, different
Region can directly or indirectly carry out liquid transmitting.In the present embodiment, different areas can be along the direction that liquid transmits end
End is connected with end, or is overlapped mutually along liquid direction of transfer, or be connected by other materials, such as connection dielectric material
(preferably water-absorbing material such as filter paper, glass fibre or nitrocellulose).When with connecting material, connecting material can make include
Material that the material of the end in each region and joining distal ends, the end comprising each region and joining distal ends but liquid do not circulate or
Comprising each region overlapped (such as, but not limited to from the beginning to the end be overlapped) but material that liquid does not circulate, liquid communication is formed.
If testing element contains detection of adulterations control zone, which can be placed on before or after test results zone.When
Control zone is contained in test results zone, and adulterated control zone is preferably positioned at before control zone, may not be such situation.This hair
Bright one embodiment, testing element are the control testing elements for judging and/or controlling for adulteration analyte, and adulterated control zone can
Before or after being located at control zone, it is preferably placed at before control zone.
Sample
It include biofluid (such as casing fluids or clinical sample with the sample that detection device of the invention can detecte
This).Liquid sample or fluid sample can from the sample of solid-state or semisolid, including excreta, biological tissue and
Food samples.The sample of solid-state or semisolid can be converted to liquid sample using any method appropriate, such as mix, smash
It is broken, macerate, be incubated for, dissolution or in a suitable solution (such as water, phosphate solution or other buffer solutions) using enzymatic hydrolysis make
With digestion of solid sample." biological sample " includes deriving from animal, plant and food samples, for example including from human or animal
Urine, saliva, blood and its ingredient, spinal fluid, vaginal fluid, sperm, excrement, sweat, secretion, tissue, organ, tumor, group
Knit the culture with organ, cell culture and medium.Preferred biological sample is urine.Food samples include the object of food processing
Matter, final products, meat, cheese, wine, milk and reference water.Plant sample includes being derived from any plant, plant tissue, and plant is thin
Born of the same parents' culture and medium." environmental samples " from environment (for example, from lake or the liquid sample of other water bodys, sewage
Sample, soil property sample, underground water, seawater and waste liquid sample).Environmental samples may also include sewage or other waste water.Utilize this
Invention and suitable detecting element, can detecte any analyte.Preferably by the analyte in present invention detection blood
Matter.
Analyte
It can include some haptens substances with the example of the analyte involved in the present invention, these haptens include poison
Product (such as drug abuse)." drug abuse " (DOA) refers to that non-medical destination uses drug (usually playing paralysis nerve).
It abuses these drugs and will lead to body & mind and be damaged, generate dependence, addicted and/or dead.Drug abuse
Example includes cocaine;Amphetamine AMP is (for example, black beauty, white amphetamine tablet, dextroamphetamine, dextrorotation benzene are different
Propylamine tablet, Beans);Crystal methamphetamine MET (crank, meth, crystal, speed);Barbiturate BAR
(such as Valium, Roche Pharmaceuticals, Nutley, New Jersey);Sedative (i.e. sleep paramedicines);Wheat
Angle acid acyl diethylamine (LSD);Inhibitor (downers, goofballs, barbs, blue devils, yellow jackets,
Methaqualone);The anti-antidepressant of tricyclic antidepressants (TCA, i.e. imipramine, amitriptyline and doxepin);Diformazan methylenedioxymethamphetamine aniline
MDMA;Phencyclidine (PCP);Tetrahydrocannabinol (THC, pot, dope, hash, weed, etc..);Opiate (i.e. morphine
MOP or opium, cocaine COC;, heroin, hydroxyl dihydrocodeinone);Anxiolytic and hypnotic sedative agent, anxiolytic
It is that one kind is mainly used for anxiety reduction, anxiety, fear, sets the mind at rest, have the drug of hypnosis sedation, including Benzodiazepine concurrently
Class BZO (benzodiazepines), it atypia BZ class, fusion phenodiazine NB23C class, benzene nitrogen Zhuo class, the ligand class of BZ receptor, opens
Ring BZ class, diphenylmethane derivatives, piperazine carboxylic acid salt, piperidine carboxylic acid salt, Kui oxazoline ketone, thiazine and thiazole,
Other heterocyclics, imidazole type calmness/anodyne (such as hydroxyl dihydrocodeinone OXY, methadone MTD), propanediol derivative-ammonia
Formate ester, aliphatic compound, anthracene derivative etc..It can be used for detection using detection device of the invention and belong to medicine
The detection of purposes but easy overdose, such as tricyclic antidepressant (imipramine or the like) and Paracetamol.This
A little drugs can resolve into different small-molecule substances after being absorbed by the body, these small-molecule substances are present in blood, urine, saliva
In the body fluid such as liquid, sweat or part body fluid there are above-mentioned small-molecule substances.
It include but is not limited to creatinine, bilirubin, nitrite, albumen (non-spy with the analyte that the present invention detects
It is anisotropic), hormone (for example, human chorionic promotes sex hormone, luteinizing hormone, follicular stimulating hormone etc.), blood, white blood cell, sugar, a huge sum of money
Belong to or toxin, bacterial components (are such as directed to the albumen or glucide of specific bacterial, such as such as colon bacillus 0157: H7, grape
Coccus, salmonella, fusobacterium, Campylobacter, L.monocytogenes, vibrio or cactus bacillus) and urine sample in
The relevant substance of physiological characteristic, such as pH and specific gravity.Other any Clinical Urinary chemical analyses are all using lateral flow test format
Cooperation apparatus of the present invention are detected.
In some embodiments, as shown in Figure 1-3, in a kind of sample analyte detection device, the detection device
Including solution storage 101, piercing element 50 and sense channel.Solution storage 101 is located at first with respect to piercing element 50
When setting, there is distance between solution storage 101 and piercing element 50;Solution storage 101 is located at second with respect to piercing element 50
When position, piercing element 50 opens 101 release solution of solution storage;Sense channel includes liquid collecting portion 402 and test department 405,
Liquid collecting portion 402 is connected to test department 405;Piercing element 50 is located in sense channel.
Liquid collecting portion 402 is used to collect the solution discharged from solution storage 101, and test department 405 is for placing testing element
(such as test strips).
As shown in figure 3, solution storage 101 is except sense channel, solution storage 101 is with respect to piercing element 50 the
When one position, solution is sealed in solution storage 101;External force makes the opposite position of solution storage 101 and piercing element 50
When being set to the second position, solution storage 101 is opened, and solution enters liquid collecting portion 402, the liquid of testing element (such as test strips)
Uptake zone absorbs the solution in liquid collecting portion, and the testing result of analyte is shown in test results zone.
Solution storage
Solution storage 101 is the device for storing solution reagent.In some embodiments, solution storage includes tool
There are the cavity of opening and the sealing element of sealed opening.Sealing element be be easy to be punctured and the material of waterproof made of film, such as
Plastic film etc..
In some embodiments, as shown in figure 12, the cavity of solution memory is surrounded by bottom plate and side wall 1011, cavity
Top opening, opening 1012 is by diaphragm seal.Alternatively, the cavity of solution memory is surrounded by bottom plate, side wall and top plate, on top plate
There are liquid-passing hole or logical liquid bath, the opening of the liquid-passing hole or logical liquid bath as cavity, opening clogs sealing by plug.
Piercing element
Piercing element is used to open the opening of solution storage, thus the solution in release solution storage.
In some embodiments, piercing element includes ontology, puncture portion and diversion trench, puncture portion face solution storage.
Puncture portion is sword or tip.
Solution storage is opened in puncture portion in a manner of puncturing film, and solution is flowed out along diversion trench, realizes solution release.
In some embodiments, puncture portion is tip.Tip punctures film, release solution.There is slot on ontology, which is diversion trench.
The cross section of diversion trench is semicircle, rectangle, V-arrangement or L shape etc.;The quantity of diversion trench is either one or more.It wears
Thorn portion is in cone.
Alternatively, puncture portion is sword.Sword punctures film, release solution.As shown in figure 14, piercing element 50 is by multiple sub-portions
501 compositions, all sub-portions 501 surround cylinder, there is gap between adjacent sub-sections 501, and each sub-portion 501 has blade.Sub-portion 501
Blade as puncture portion 502;Gap between sub-portion 501 is as diversion trench 503.Alternatively, piercing element is in cylinder or circular cone
Body, piercing element is interior to be equipped with open-topped channel, and puncture channel is equipped with the liquid-passing hole or logical liquid bath that channel is in communication with the outside,
The opening in channel has sword.Sword is as puncture portion, channel and liquid-passing hole or logical liquid bath as diversion trench.When the sword of piercing element connects
When contacting film, sword punctures film, liquid inlet channel, and reaches liquid collecting portion through liquid-passing hole or logical liquid bath.
Movable member
When solution storage or piercing element are mounted on movable member, when movable member is displaced, so that solution storage and wearing
Pierce element relative displacement, thus realize solution from be sealed to release.
In some embodiments, detection device, which has, to include press section and position to the movable member of bottom offset, movable member
Shifting portion, piercing element or solution storage are fixed on movable member.Have and the matched movable member of movable member in detection device
Window, movable member are inserted into movable member window.
In some embodiments, as shown in Fig. 1, Fig. 4, Fig. 7 and Figure 12, displacement portion is sleeve 102, is had in detection device
The guide post 404 cooperated with sleeve 102;The first end of sleeve 102 and press section 103 are fixed, the second end and guide post of sleeve 102
404 cooperations.When initial, sleeve is placed on guide post, and as sleeve is moved along guide post, solution storage and piercing element are mutually leaned on
Closely.
In some embodiments, displacement portion is guide post, has the sleeve cooperated with guide post in detection device;The first of guide post
End is fixed with press section, and the second end and sleeve of guide post cooperate.When initial, guide post is placed on sleeve, and guide post is moved along sleeve
Keep solution storage and piercing element close to each other.
Hemostix
Hemostix 30 is used to collect sample, such as blood sample.
In some embodiments, as shown in Figure 1 and Figure 4, detection device is equipped with hemostix 30, and hemostix is tubular structure.
Hemostix includes blood sampling head, collects blood sample using the blood sampling head.Preferably, hemostix one end connection blood sampling head 301, separately
One end is blood sampling pipet 302, and blood sampling head is air bag.Have on detection means and allows the mounting portion 203 of the detachable assembly of hemostix.
Mounting portion 203 is affixed to the sleeve of detection device, and sleeve is open at one end.Hemostix is out of opening insertion sleeve.Alternatively, installation
Portion is affixed to the elastic buckles of detection device, and elastic buckles have the bayonet for allowing hemostix to enter.Hemostix is caught in bullet from opening
In property button.
Puncture device
Puncturing device 70 is for scratching skin or tissue to discharge the device of blood.Puncturing device is common puncturing machine
Structure, such as disposable safe blood-taking needle, generally puncturing device includes a sharp needle, is used to penetrating tissue bloodletting.Disposably
Safe blood-taking needle is after needle transmitting, and needle core will be lockable, so that blood taking needle is used only once, it is ensured that the peace of user
Entirely.
As shown in figure 9, in some embodiments, detection device has the receiving area for accommodating penetrating tissue, device installation is punctured
In receiving area, and puncture that device one end is exposed, the exposed junction for puncturing device contains lancet.Lancet is used to penetrating tissue to discharge
Blood.
In some embodiments, puncturing device includes the ontology for being connected in detection device and the appearance needle cavity for accommodating needle, holds needle cavity
Expose to detection device.
The shell of detection device
Shell provides accommodation space to puncture device, solution storage and sense channel.
As Figure 7-9, in some preferred schemes, detection device has shell, has solution storage in shell
101, piercing element 50, puncture device 70 and testing element 80, puncture device 70, solution storage 101 and piercing element 50 and be integrated in
It is exposed to puncture 70 one end of device for shell.Preferably, solution storage 101 or piercing element 50 are installed on movable member 10, movable member
10, solution storage 101 and piercing element 50 are located at the first area of shell, and first area has the space of movable member displacement.
Preferably, testing element 80 includes at least imbibition area 801, sample application zone 802 and test results zone 803, the imbibition of testing element 80
Area 801 is located at first area, and the imbibition area 801 of testing element 80 and the part other than sample application zone 802 are located at the secondth area of shell
Domain, installation space needed for second area has testing element 80.The liquid collecting portion 402 of sense channel is located at first area, detection
The test department 405 in channel is located at second area.Solution reaches liquid collecting portion 402 after being released, molten after 80 absorbent solution of testing element
Liquid dissolves sample by sample application zone 802, and sample is shown after reaching test results zone 803 through capillary action, reacting with reagent
Show result.
First area meets the running space of movable member;Second area meets the installation space of testing element.First area
Need to meet space requirement of the movable member from first position to the second position, the height of second area only needs that test member can be accommodated
Part and bracket.Second area accommodates mounted testing element, the freedom degree of testing element upper and lower, left and right quilt just
Limitation, therefore the position of testing element is stablized, and guarantees the accuracy rate of detection.Preferably, lower plate is plate, the first area of upper plate
Pass through chamfered transition with second area.
As Figure 7-9, in some preferred schemes, the end that device 70 is located at shell is punctured.Preferably, device 70 is punctured
Positioned at first area.It punctures device and is located at end, use when facilitating blood sampling.As shown in Figure 1 and Figure 4, in some preferred schemes,
Shell be equipped with movable member window 201, the display window 202 of testing result and allow to puncture device loading puncture device window 205.Inspection
Surveying device has shell, and piercing element 50, solution storage 101 and sense channel are respectively positioned in shell, and shell is equipped with movable member
Window 201, the display window 202 of testing result and allow to puncture device loading puncture device window 205.As shown in 1-10 and 13,
Shell includes upper plate 20 and lower plate 40, and movable member window 201 and display window 202 are set to upper plate, and sense channel is set to lower plate;It wears
Pierce element 50 be set to movable member 10 when, solution storage 101 be set to lower plate 40, solution storage 101 be set to movable member 10 when, wear
It pierces element 50 and is set to lower plate 40.
As shown in Figure 10, in some embodiments, upper plate is equipped with the sample-adding window 204 of sample application, is loaded window 204
Between movable member window 201 and display window 202.
As shown in fig. 7, in some embodiments, puncturing device window 205 set on upper plate 20, or puncture device window by upper plate
Notch and the notch of lower plate be combined into.
Testing element and sense channel
In some embodiments, detection device further includes testing element.It can detecte in blood sample by testing element
The presence or quantity of analyte.As shown in figure 15, testing element includes imbibition end 801, sample application zone 802 and detection
Fruiting area 803, imbibition end 801 are communicated with the liquid collecting portion 402 of sense channel, the solution that draw solution storage 101 discharges.Sample
Sample-adding window 204 in 802 corresponding housing of sample application zone, the corresponding display window 202 in test results zone 803.
As shown in Figure 1 and Figure 4, in some embodiments, sense channel is equipped with card slot element 403, and testing element 80 is removable
Unload being installed in card slot element 403 of formula.Preferably, lower plate has bracket 401, and bracket is located in sense channel, testing element
80 are placed on bracket 401.Bracket 401 erects testing element 80, avoids solution Soak Test element.
As shown in fig. 6, in some embodiments, movable member 10, solution storage 101 and piercing element 50 are located at shell
First area, testing element 80 are located at the second area of shell, and the liquid collecting portion 402 of sense channel is located at first area, and detection is logical
The test department 405 in road is located at second area.Solution reaches liquid collecting portion 402, after 80 absorbent solution of testing element, solution after being released
Dissolve sample by sample application zone 802, sample reaches test results zone 803 through capillary action, reacted with reagent after show
As a result.
The height of first area is greater than the height of second area.Height refers to that lower plate 20 arrives the distance of upper plate 40.First
The height in region needs to meet the space of the operation of movable member 10, and the height of second area only needs that testing element and bracket can be accommodated
?.The height of second area accommodates mounted testing element 80 just, and the freedom degree of 80 upper and lower, left and right of testing element is equal
It is limited, therefore the position of testing element 80 is stablized, guarantees the accuracy rate of detection.Preferably, lower plate is plate, the first of upper plate
Region and second area pass through chamfered transition.
In some embodiments, as Figure 7-9, the end that device is located at shell is punctured.It punctures device and is located at first area.Thorn
Broken device is located at end, use when facilitating blood sampling.
Anti-misoperation lid
As shown in Fig. 4-6 and Figure 11, in some embodiments, detection device further includes anti-misoperation lid 60, anti-misoperation
Lid 60 covers 201 mouthfuls of movable member window.Anti-misoperation lid is that movable member is avoided to run and cause the one of product failure because of maloperation
Kind safeguard measure.Preferably, anti-misoperation lid is rotatably connected at shell.Preferably, between anti-misoperation lid 60 and shell
It is connected by rotating connector, rotating connector includes connecting rod 601, and 601 one end of connecting rod is connect with anti-misoperation lid 60, another
End is connect with shell.Preferably, the two sides of shell are respectively set connecting rod, and connecting rod one end and shell fix, the other end and anti-
Maloperation lid rotation connection, alternatively, connecting rod one end is connect with housing into rotation, the other end and anti-misoperation lid are fixed.
On the other hand, the present invention provides a kind of method for detecting analyte in blood sample, this method comprises: providing
Detection device, the detection device include testing element 80, and solution storage 101 can puncture the piercing element 50 of storage,
Middle solution storage 101 has first position and the second position in detection device;Solution storage 101 is allowed to move from first position
It moves to the second position;In the process of moving, piercing element 50 is allowed to puncture solution storage 101, thus release solution storage
Solution in 101.
At this point, solution storage device is in the state separated with detection device, wait after applying sample, receiving solution is allowed to deposit
The storing apparatus of reservoir covers in channel design, allows the one end in channel to be directed at solution receiving cavity by one end of diaphragm seal, pushes away
Dynamic solution storage device is from first movement to the second position, and since puncturing elements are located on channel, puncture structure is inserted into solution appearance
The seal on both sides of cavity received goes out, and is further inserted into solution receiving cavity with channel, and puncture structure is deeply inserted into, from
And force solution to enter in channel from the opening in channel because card slot element is close to the opening in channel, by access portal into
The solution entered also enters in card slot therewith, then flows into sample applying zone, the solution stream being flowed into applying zone
The corresponding sample applying zone of sample application well is crossed, sample disposed thereon is handled, to complete to test or chemically examine.
Above method is for blood sample, when not being blood sample, it may not be necessary to puncture device, and directly use
Hemostix carries out taking for sample, such as saliva, and excrement etc. such as above can carry out the explanation of sample with hemostix
It takes.
In the case where lacking any element specifically disclosed herein, limitation, may be implemented illustrated and described herein
Invention.Used terms and expressions method is used as the term of explanation rather than limits, and is not intended in these terms and table
Up to any equivalent for excluding shown and described feature or part thereof in the use of method, and it should be realized that various remodeling exist
It is all feasible in the scope of the present invention.It is therefore to be understood that although specifically being disclosed by various embodiments and optional feature
The present invention, but the modifications and variations of concept as described herein can be used by those of ordinary skill in the art, and recognize
It is fallen into for these modifications and variations within the scope of the present invention of the appended claims restriction.
It is described herein or record article, patent, patent application and every other document and can electronically obtain
The content of information to a certain extent in full include herein by reference, just as each individual publication by specific and single
Solely point out by reference.Applicant retains from any of any this article, patent, patent application or other documents
And all material and information are incorporated into the right in the application.
Claims (10)
1. the detection device of analyte in sample, it is characterised in that: the detection device includes solution storage, piercing element
And sense channel;When solution storage is located at first position with respect to piercing element, have between solution storage and piercing element away from
From;When solution storage is located at the second position with respect to piercing element, piercing element opens solution storage;Sense channel includes holding
It connects the carrier of solution and places the test department of test-strips, carrier is connected to test department;Piercing element is located at carrier.
2. the detection device of analyte in sample as described in claim 1, it is characterised in that: detection device has can
The movable member of displacement, movable member include press section and displacement portion, and piercing element or solution storage are fixed on movable member.
3. the detection device of analyte in sample as claimed in claim 2, it is characterised in that: displacement portion is sleeve, inspection
Surveying has the guide post cooperated with sleeve on device;The first end of sleeve is fixed with press section, and the second end and guide post of sleeve cooperate;
Alternatively, displacement portion is guide post, there is the sleeve cooperated with guide post in detection device;The first end of guide post is fixed with press section, is led
The second end and sleeve of column cooperate.
4. the detection device of analyte in sample as described in claim 1, it is characterised in that: piercing element includes puncturing
Portion and diversion division;Puncture portion is sword or tip;Solution storage device includes the cavity for accommodating solution reagent, which is easy
The diaphragm seal punctured, puncture portion is against film;Puncture portion release solution in a manner of puncturing film.
5. the detection device of analyte in sample as described in claim 1, it is characterised in that: detection device is removably
Equipped with hemostix.
6. the detection device of analyte in sample as described in claim 1, it is characterised in that: detection device is equipped with and punctures
Tissue punctures device;Puncture that device one end is exposed, the exposed junction for puncturing device contains lancet.
7. the detection device of analyte in sample as described in claim 1, it is characterised in that: detection device has shell
Body, movable member, solution storage and piercing element are located at the first area of shell, and testing element is located at the second area of shell,
The liquid collecting portion of sense channel is located at first area, and the test position of sense channel is in second area.
8. the detection device of analyte in sample as claimed in claim 7, it is characterised in that: first area meets movable
The running space of part;Second area meets the installation space of testing element.
9. the detection device of analyte in sample as claimed in claim 8, it is characterised in that: first area has movable
Part window, puncture device loading punctures device window;Second area has the display window of testing result.
10. the detection device of analyte in sample as claimed in claim 2, it is characterised in that: detection device includes anti-
Maloperation lid, anti-misoperation lid cover movable member.
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CN201810578554.8A CN108968982A (en) | 2018-06-07 | 2018-06-07 | The detection device of analyte in sample |
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