CN209863848U - Detection device with anti-misoperation function - Google Patents

Abstract

The utility model provides a detection device with prevent maloperation, this detection device include the casing, are equipped with swing joint's movable part in the casing, are equipped with the lid of preventing maloperation that covers the movable part on the casing. The misoperation prevention cover is a protection measure for preventing the movable part from operating due to misoperation to cause product failure. Use the utility model discloses a device lets the blood sampling, and buffer solution, detection device structure as an organic whole can one step accomplish blood sample's collection and detection.

Description

Detection device with anti-misoperation function

Technical Field

The utility model relates to a detection device with prevent maloperation, in particular to belong to the device that detects the analyte in the blood sample.

Background

The following background is provided to aid the reader in understanding the present invention and is not admitted to be prior art.

Blood has been a frequently used sample in the field of testing because blood contains many biological indicators or analytes. In POCT, if the analyte substance of blood is to be detected, it is generally necessary to collect the blood, for example, to puncture a capillary vessel on the skin with a blood collection needle, collect a blood sample with a blood collection tool, and then analyze the blood sample. When an individual performs a blood sample test, a blood collection needle, a blood collection tool, and a test device are generally required, and a solution reagent for treating blood is generally provided. Generally, these appliances are packaged together, which is not only disadvantageous to packaging, but also causes troubles in use or damages to human body.

There is a need for an improved conventional device for testing blood samples to overcome the above drawbacks and to provide convenience and convenience to the user.

SUMMERY OF THE UTILITY MODEL

In order to solve the problems existing in the prior art, the present invention provides a device for detecting analytes in a fluid sample, particularly in a blood sample.

The utility model provides a detection device with prevent maloperation which characterized in that: the detection device comprises a solution storage device, a puncture element and a detection channel; the solution storage device is positioned at a first position relative to the puncture element, and a distance is reserved between the solution storage device and the puncture element; when the solution storage device is positioned at a second position relative to the puncture element, the puncture element opens the solution storage device to release the solution; the detection channel comprises a liquid collecting part and a testing part, and the liquid collecting part is communicated with the testing part; the puncturing element is located in the detection channel.

The liquid trap part is used for collecting the solution discharged from the solution storage and the test part is used for holding a test element (such as a test strip).

The solution storage device is arranged outside the detection channel, when the solution storage device is at a first position relative to the puncture element, the solution storage device and the puncture element are not contacted with each other, and the solution is sealed in the solution storage device; when the relative position of the solution storage device and the puncture element is the second position due to the external force, the puncture element opens the solution storage device, the solution enters the liquid collecting part, and the test element (such as a test strip) absorbs the solution in the liquid collecting part to display the detection result.

Piercing element

The piercing element is used to open the opening of the solution reservoir to release the solution in the solution reservoir.

Preferably, the piercing element faces the solution reservoir and the piercing element channel has a blade or tip.

The puncture part opens the solution storage device in a mode of puncturing the film, and the diversion trench realizes the release of the solution. In one embodiment, the tip surface is preferably provided with a diversion trench. The cross section of the diversion trench is semicircular, rectangular, V-shaped or L-shaped; the number of the diversion trenches can be 1 or more. Preferably, the piercing portion is conical.

The other scheme is as follows: preferably, the puncturing element is composed of a plurality of sub-portions, all the sub-portions surround a column body, gaps are reserved between adjacent sub-portions, each sub-portion is provided with a blade, and the gaps between the sub-portions are used as flow guide grooves. Or the puncture element is a cylinder or a cone, a channel with an opening at the top is arranged in the puncture element, the puncture channel is provided with a liquid through hole or a liquid through groove which communicates the channel with the outside, and the opening of the channel is provided with a blade. The blade is used as a puncture part, and the channel and the liquid through hole or the liquid through groove are used as a diversion trench. When the blade of the piercing member contacts the membrane, the blade pierces the membrane, and the liquid enters the channel and reaches the liquid collection portion through the liquid passage hole or the liquid passage groove.

Movable part

When the solution storage device or the puncturing element is arranged on the movable piece, the movable piece is displaced, so that the solution storage device and the puncturing element are relatively displaced, and the solution is released from the sealing.

Preferably, the detection device includes a movable member capable of displacement, the movable member includes a pressing portion and a displacement portion, and the puncture element or the solution storage container is fixed to the movable member.

Preferably, the displacement part is a sleeve, and the detection device is provided with a guide post matched with the sleeve; the first end of the sleeve is fixed with the pressing part, and the second end of the sleeve is matched with the guide pillar. Initially, the sleeve is placed over the guide post and the solution reservoir and piercing element are brought into proximity with each other as the sleeve moves along the guide post.

Or the displacement part is a guide post, and the detection device is provided with a sleeve matched with the guide post; the first end of the guide post is fixed with the pressing part, and the second end of the guide post is matched with the sleeve. Initially, the guide post is placed on the sleeve and the guide post is moved along the sleeve to bring the solution reservoir and the piercing element into proximity with each other.

Preferably, the detection device has a movable piece window matched with the movable piece, and the movable piece is inserted into the movable piece window.

Solution storage device

The solution storage is a device for storing solution reagents. Preferably, the solution reservoir includes a cavity having an opening and a sealing member sealing the opening. Preferably, the sealing member is a film made of a material that is easily punctured and waterproof, such as a plastic film or the like. Preferably, the cavity of the solution storage is enclosed by a bottom plate and a side wall, the top of the cavity is opened, and the opening is sealed by a film.

Blood sampler

Blood collection devices are used to collect samples, such as blood samples.

Preferably, the detection device is provided with a blood sampling device. Preferably, the blood sampling device is a tubular structure and comprises a blood sampling head, and the blood sampling head is used for collecting blood samples. Preferably, one end of the hemostix is connected with the blood collecting head, the other end of the hemostix is provided with the blood sucking tube, and the blood collecting head is provided with the air bag. Preferably, the detection device includes an attachment portion to which the blood sampling device is detachably attached. Preferably, the mounting portion is a sleeve fixed to the detection device, and one end of the sleeve is open. The blood sampling device is inserted into the sleeve from the opening. Alternatively, the mounting part is an elastic buckle which is fixed on the detection device and is provided with a bayonet allowing the blood collector to enter. The hemostix is clamped into the elastic buckle from the opening.

Puncture outfit

A lance is a device used to lacerate the skin or tissue to release blood. Lancers are commonly used lancing mechanisms, such as disposable safety lancets, and typically comprise a sharp needle for lancing tissue for bleeding. After the disposable safety blood taking needle is launched by the needle, the needle core is locked, so that the blood taking needle can be used only once, and the safety of a user can be ensured.

Preferably, the detection device has a puncture device for receiving the punctured tissue, one end of the puncture device is exposed, and the exposed end of the puncture device contains a puncture needle. The lancet is used to pierce tissue to release blood. Preferably, the puncture device comprises a body clamped to the detection device and a needle containing cavity for containing the needle, and the needle containing cavity is exposed out of the detection device.

Test element and detection channel

Preferably, the detection device further comprises a test element. The presence or quantity of an analyte in a blood sample can be detected by the test element. Preferably, the test element includes a liquid-sucking end, a sample application area and a reagent test area, the liquid-sucking end is communicated with the liquid-collecting part of the detection channel and sucks the solution released from the solution reservoir. The sample adding area corresponds to the sample adding window on the shell, and the actual testing area corresponds to the display window.

Preferably, the detection channel is provided with a card slot element, and the test element is detachably mounted in the card slot element. Preferably, the lower plate has a carrier, the carrier being located in the detection channel, the test element being placed on the carrier. The test element is lifted by the bracket to prevent the test element from being soaked by the solution.

Casing of detection device

The housing provides a holding space for the penetrator, the solution reservoir and the detection channel.

Preferably, the detection device comprises a housing, the housing is internally provided with a solution storage device, a puncture element, a puncture device and a test element, the puncture device, the solution storage device and the puncture element are integrated in the housing, and one end of the puncture device is exposed. Preferably, the solution reservoir or the puncturing element is mounted to the movable member, and the movable member, the solution reservoir and the puncturing element are located in a first region of the housing, the first region having a space in which the movable member is displaced. Preferably, the test element includes at least a liquid suction area, a sample application area, and a result display area, the liquid suction area of the test element is located in the first area, and the portion of the test element other than the liquid suction area and the sample application area is located in the second area of the housing, the second area having a mounting space required for the test element. The liquid collecting part of the detection channel is positioned in the first area, and the testing part of the detection channel is positioned in the second area. The solution is released and reaches the liquid collecting part, after the test element absorbs the solution, the solution dissolves the sample through the sample adding region, and the sample reaches the reagent test region through capillary action and reacts with the reagent to display a result.

The first area satisfies the running space of the movable piece; the second region satisfies the mounting space of the test element. The first region needs to meet the space requirement for the movable member from the first position to the second position, and the height of the second region need only be able to accommodate the test element and the carrier. The second area just accommodates the mounted test element, and the freedom degrees of the test element in the upper, lower, left and right directions are all limited, so that the position of the test element is stable, and the accuracy of detection is ensured. Preferably, the lower plate is a flat plate, and the first region and the second region of the upper plate are transited by a slope.

Preferably, the piercer is located at an end of the housing. Preferably, the piercer is located in the first region. The puncture outfit is positioned at the end part, so that the puncture outfit is convenient to use in blood sampling.

Preferably, the housing is provided with a movable member window, a display window for the detection result and a puncture device window for allowing the puncture device to be fitted therein. Preferably, the housing comprises an upper plate and a lower plate, the movable piece window and the display window are arranged on the upper plate, and the detection channel is arranged on the lower plate; when the puncture element is arranged on the movable piece, the solution storage device is arranged on the lower plate, and when the solution storage device is arranged on the movable piece, the puncture element is arranged on the lower plate.

Preferably, the upper plate is provided with a sample application window for applying a sample, and the sample application window is located between the movable element window and the display window.

Preferably, the puncture device window is arranged on the upper plate, or the puncture device window is formed by splicing a notch of the upper plate and a notch of the lower plate.

Anti-misoperation cover

Preferably, the detection device comprises a housing, a movably connected movable member is arranged in the housing, and an anti-misoperation cover for covering the movable member is arranged on the housing. Preferably, the movable member window is covered by the erroneous operation preventing cover, and the erroneous operation preventing cover has a rib enclosing the movable member window therein. The misoperation prevention cover is a protection measure for preventing the movable part from operating due to misoperation to cause product failure. Preferably, the erroneous operation preventing cover is rotatably coupled to the housing. Preferably, prevent being connected by rotating the connecting piece between maloperation lid and the casing, rotate the connecting piece and include the connecting rod, connecting rod one end with prevent maloperation lid and be connected, the other end is connected with the casing. Preferably, the both sides of casing set up the connecting rod respectively, and connecting rod one end is fixed with the casing, and the other end is connected with preventing that the maloperation lid rotates, perhaps, connecting rod one end is connected with the casing rotation, the other end is fixed with preventing the maloperation lid.

In another aspect, the present invention provides a method for detecting an analyte in a blood sample, the method comprising:

providing a test device comprising a test element, a solution reservoir, a piercing element capable of piercing the reservoir, wherein the solution reservoir has a first fixed position and a second position in the test device; moving the solution reservoir from a first location to a second location; during the movement, the piercing element is allowed to pierce the solution reservoir, thereby releasing the solution in the solution reservoir.

Advantageous effects

Use the utility model discloses a device lets the blood sampling, and buffer solution, detection device structure as an organic whole can one step accomplish blood sample's collection and detection.

Drawings

Fig. 1 is a schematic diagram of a three-dimensional explosion structure of a detection device according to an embodiment of the present invention.

Fig. 2 is a front view of the detecting device of fig. 1 according to the present invention.

Fig. 3 is an assembled cross-sectional view of the detecting device of fig. 1 according to the present invention.

Fig. 4 is a schematic perspective view of a detection device with a misoperation prevention cover according to an embodiment of the present invention.

Fig. 5 is a schematic diagram of a front-view direction explosion structure of the detecting device with the anti-misoperation cover in fig. 4 according to the present invention.

Fig. 6 is an assembled cross-sectional view of the detecting device with the erroneous operation preventing cover of fig. 4 according to the present invention.

Fig. 7 is a perspective exploded view of a detection device with a puncture device according to an embodiment of the present invention.

Fig. 8 is a front view of the testing device with a puncture device of fig. 7 according to the present invention.

Fig. 9 is an assembled cross-sectional view of the testing device with a lancet of fig. 7 in accordance with the present invention.

Fig. 10 is a schematic perspective view of an upper plate according to an embodiment of the present invention.

Fig. 11 is a schematic perspective view of the lid for preventing the misoperation in one embodiment of the present invention.

Fig. 12 is a schematic perspective view of a movable member according to an embodiment of the present invention.

Fig. 13 is a schematic perspective view of a lower plate according to an embodiment of the present invention.

Fig. 14 is a perspective view of a puncturing element in accordance with an embodiment of the present invention.

Fig. 15 is a schematic view of a test element according to an embodiment of the invention.

Detailed Description

The structures referred to in the present invention or these terms of art used are further described below. These illustrations are merely exemplary of how the present invention may be implemented and are not intended to limit the present invention in any way.

Detection of

Detection refers to assaying or testing for the presence of a substance or material, such as, but not limited to, a chemical, organic compound, inorganic compound, metabolic product, drug or drug metabolite, organic tissue or a metabolite of an organic tissue, nucleic acid, protein, or polymer. In addition, detection indicates the amount of the test substance or material. Further, the assay means immunodetection, chemical detection, enzyme detection, and the like.

Test element

A plurality of test elements can be used in combination in the present invention. The test element comprises a test element 80, and the analytical test element may take a variety of forms, for example, in an immunological or chemical test form for detecting an analyte in a sample, such as a drug or a related metabolite indicative of a physical condition. In some forms the test element is a bibulous material having a sample application zone, a reagent zone, and a test result zone. The sample is applied to the sample application zone and flows into the reagent zone by capillary action. In the reagent zone, the sample dissolves the reagent and mixes with it for detection of the analyte (if present in the sample). The sample with the reagent now continues to flow to the detection result zone. Additional reagents are immobilized in the detection result zone. These reagents immobilized on the detection result zone react with and bind to the analyte (if present) or the first reagent of the reagent zone. In a non-competitive assay format, a signal is generated if the analyte is present in the sample and no signal is generated if the analyte is not present. In a competitive assay format, a signal is generated if the analyte is not present in the sample and no signal is generated if the analyte is present. The utility model is suitable for a various analysis form.

When the test element is a test element, it may be made of absorbent or non-absorbent materials, and a plurality of materials may be used for one test element for liquid transfer. One material of the test element may be superimposed on another test element material, for example, filter paper superimposed on nitrocellulose. Alternatively, one region of the test element containing at least one material is located behind another region containing at least one different material. In this case, the liquid flows between the zones, which may or may not be superimposed on each other. The material on the test element may be fixed to a support such as a plastic backing or a hard surface to enhance the holding power of the test element.

In some embodiments in which the analyte is detected by the signal producing system (e.g., at least one enzyme specifically reacts with the analyte), the at least one signal producing substance can be adsorbed onto the test result zone of the test element as described above, specifically onto the material of the test element. In addition, the signal-producing substance present in the sample application zone, the reagent zone, the detection result zone, or throughout the test element, of the test element may be pre-treated on one or more materials of the test element in advance. This can be achieved by applying a solution of the signal-generating substance to the surface of the application zone or by immersing one or more materials of the test element in the signal solution. After the test element is added with the signal solution or soaked in the solution, the test element is dried. In addition, the above methods may be present in the sample application zone, the reagent zone, the detection result zone of the test element, or the signal-producing substance may be pre-treated on one or more materials of the test element in advance throughout the entire test element. In addition, a signal substance present in the sample application zone, the reagent zone, or the detection result zone of the test element may be applied to one or more surfaces of the test element material as a labeled reagent.

As shown in FIG. 15, the test element 80 includes at least a liquid-absorbing region 801, a sample-applying region 802, and at least one detection result region 803 arranged in this order. If the test result zone 803 includes a control zone 804, it is preferred that the control zone 804 be located after the analyte detection zone of the test result zone 803. All of these zones or combinations thereof may be on a single strip containing one material. In addition, the zones are made of different materials and are joined together in the direction of liquid transfer. For example, the different zones may be in direct or indirect fluid communication. In this embodiment, the different zones may be end-to-end connected in the direction of liquid transfer, or superimposed on each other in the direction of liquid transfer, or connected by other materials, such as a connecting medium material (preferably a water-absorbent material such as filter paper, glass fibers or nitrocellulose). In the case of a connecting material, the connecting material allows liquid communication to be formed by a material including regions in which the ends are in contact with each other, a material including regions in which the ends are in contact with each other but liquid does not flow, or a material including regions in which the regions overlap with each other (for example, but not limited to, overlapping from end to end) but liquid does not flow.

If the test element contains an adulteration control zone, this zone may be placed before or after the test result zone. This may or may not be the case when the detection result area contains a control area, the adulteration control area preferably being placed before the control area. In one embodiment of the present invention, the test element is a control test element for adulteration analysis determination and/or control, and the adulteration control area can be located before or after the control area, preferably before the control area.

Sample(s)

The sample that can be detected by the detection device of the present invention includes a biological fluid (e.g., a case fluid or a clinical sample). Liquid or fluid samples may be derived from solid or semi-solid samples, including fecal matter, biological tissue, and food samples. The solid or semi-solid sample may be converted to a liquid sample by any suitable method, such as mixing, triturating, macerating, incubating, dissolving, or enzymatically digesting a solid sample in a suitable solution (e.g., water, phosphate solution, or other buffered solution). "biological samples" include samples derived from animals, plants and food, including, for example, urine, saliva, blood and components thereof, spinal fluid, vaginal secretions, sperm, feces, sweat, secretions, tissues, organs, tumors, cultures of tissues and organs, cell cultures and media derived from humans or animals. Preferably the biological sample is urine. Food samples include food processing materials, end products, meat, cheese, wine, milk and drinking water. Plant samples include those derived from any plant, plant tissue, plant cell culture and medium. An "environmental sample" is derived from the environment (e.g., a liquid sample from a lake or other body of water, a sewage sample, a soil sample, groundwater, seawater, and a waste liquid sample). The environmental sample may also include sewage or other wastewater. By using the utility model and a suitable detection element, any analyte can be detected. The utility model discloses the analyte matter in the detection blood is preferably utilized.

Analyte substance

Examples of analytes that can be used in the present invention include haptenic substances, including drugs of abuse (e.g., drugs of abuse). By "drug of abuse" (DOA) is meant the use of a drug (usually acting to paralyze nerves) at a non-medical destination. Abuse of these drugs can result in physical and mental damage, dependence, addiction and/or death. Examples of drug abuse include cocaine; amphetamine AMP (e.g., black americane, white amphetamine tablets, dextroamphetamine tablets, Beans); methamphetamine MET (crank, methamphetamine, crystal, speed); barbiturate BAR (e.g., Valium, Roche Pharmaceuticals, Nutley, New Jersey); sedatives (i.e., sleep-aid drugs); lysergic acid diethylamide (LSD); inhibitors (downs, goofballs, barbs, blue devils, yellowjacks, hypnones); tricyclic antidepressants (TCAs, i.e., imipramine, amitriptyline and doxepin); dimethyldioxymethylaniline MDMA; phencyclidine (PCP); tetrahydrocannabinol (THC, pot, dope, hash, weed, etc.); opiates (i.e., morphine, or opiates, cocaine, COC; heroin, dihydrocodeinone); anxiolytic and sedative hypnotic, anxiolytic is a kind of mainly used for relieving anxiety, stress, fear, stabilize mood, have hypnotic sedative effects at the same time, including benzodiazepine BZO (benzodiazepines), atypical BZ, fuse dinitrogen NB23C, benzodiazepine, BZ receptor ligand, ring-opening BZ, diphenylmethane derivatives, piperazine carboxylate, piperidine carboxylate, quinazolone, thiazine and thiazole derivatives, other heterocycles, imidazole type sedative/analgesic (such as dihydrocodeinone OXY, methadone MTD), propylene glycol derivative-carbamate, aliphatic compound, anthracene derivatives, etc.. The detection device of the utility model can also be used for detecting the detection which belongs to the medical purpose and is easy to take excessive medicine, such as tricyclic antidepressants (imipramine or analogues) and acetaminophen, etc. After being absorbed by human body, the medicines are decomposed into different small molecular substances, and the small molecular substances exist in body fluids such as blood, urine, saliva, sweat and the like or exist in partial body fluids.

Analytes to be detected by the present invention include, but are not limited to, creatinine, bilirubin, nitrite, protein (non-specific), hormones (e.g., human chorionic gonadotropin, progesterone hormone, follicle stimulating hormone, etc.), blood, leukocytes, sugars, heavy metals or toxins, bacterial material (e.g., proteins or carbohydrates specific to a bacterium, such as Escherichia coli 0157: H7, staphylococci, Salmonella, Clostridia, Campylobacter, L.monocytogenes, Vibrio, or Cactus), and substances associated with physiological characteristics in urine samples, such as pH and specific gravity. The usable side direction crossing current of other clinical urine chemistry analysis portion detects the form cooperation the utility model discloses the device detects.

In some embodiments, as shown in FIGS. 1-3, a test device with anti-tampering includes a solution reservoir 101, a piercing element 50, and a test channel. The solution reservoir 101 is spaced from the piercing element 50 when the solution reservoir 101 is in a first position relative to the piercing element 50; when the solution storage 101 is located at the second position relative to the puncturing element 50, the puncturing element 50 opens the solution storage 101 to release the solution; the detection channel includes a liquid collection portion 402 and a test portion 405, the liquid collection portion 402 communicates with the test portion 405; the piercing element 50 is located within the detection channel.

The liquid collecting part 402 is used to collect the solution discharged from the solution storage 101, and the test part 405 is used to mount a test element (e.g., a test strip).

As shown in fig. 3, the solution reservoir 101 is outside the detection channel, and the solution is sealed within the solution reservoir 101 when the solution reservoir 101 is in the first position relative to the penetrating member 50; when the relative position of the solution storage 101 and the piercing member 50 is set to the second position by the external force, the solution storage 101 is opened, the solution enters the liquid collecting portion 402, the solution in the liquid collecting portion is absorbed by the liquid absorbing region of the test member (e.g., a test strip), and the result of the detection of the analyte is displayed in the detection result region.

Solution storage device

The solution reservoir 101 is a device for storing a solution reagent. In some embodiments, the solution reservoir includes a cavity having an opening and a seal sealing the opening. The sealing member is a film made of a material which is easily punctured and is waterproof, such as a plastic film or the like.

In some embodiments, as shown in fig. 12, the volume of the solution reservoir is defined by a floor and a sidewall 1011, the top of the volume is open, and the opening 1012 is sealed by a film. Or the containing cavity of the solution storage is enclosed by a bottom plate, a side wall and a top plate, the top plate is provided with a liquid through hole or a liquid through groove, the liquid through hole or the liquid through groove is used as an opening of the containing cavity, and the opening is plugged and sealed by a plug.

Piercing element

The piercing element is used to open the opening of the solution reservoir to release the solution in the solution reservoir.

In some embodiments, the piercing element comprises a body, a piercing portion and a channel, the piercing portion facing the solution reservoir. The piercing portion is a blade or tip.

The puncture part opens the solution storage device in a mode of puncturing the film, and the solution flows out along the diversion trench to realize the release of the solution. In some embodiments, the piercing portion is a tip. The tip punctures the membrane and releases the solution. The body is provided with a groove which is a diversion trench. The cross section of the diversion trench is semicircular, rectangular, V-shaped or L-shaped; the number of the flow guide grooves can be one or more. The puncture part is conical.

Alternatively, the piercing portion is a blade. The blade pierces the film, releasing the solution. As shown in fig. 14, the puncturing element 50 is composed of a plurality of sub-portions 501, all the sub-portions 501 enclose a column, a gap is provided between adjacent sub-portions 501, and each sub-portion 501 has a blade. The blade of the sub-portion 501 is a piercing portion 502; the gaps between the sub-portions 501 serve as channels 503. Or the puncture element is a cylinder or a cone, a channel with an opening at the top is arranged in the puncture element, the puncture channel is provided with a liquid through hole or a liquid through groove which communicates the channel with the outside, and the opening of the channel is provided with a blade. The blade is used as a puncture part, and the channel and the liquid through hole or the liquid through groove are used as a diversion trench. When the blade of the piercing member contacts the membrane, the blade pierces the membrane, and the liquid enters the channel and reaches the liquid collection portion through the liquid passage hole or the liquid passage groove.

Movable part

When the solution storage device or the puncturing element is arranged on the movable piece, the movable piece is displaced, so that the solution storage device and the puncturing element are relatively displaced, and the solution is released from the sealing.

In some embodiments, the detection device has a movable member capable of being displaced downward, the movable member including a pressing portion and a displacement portion, and the puncturing element or the solution reservoir is fixed to the movable member. The detection device is provided with a movable piece window matched with the movable piece, and the movable piece is inserted into the movable piece window.

In some embodiments, as shown in fig. 1, 4, 7 and 12, the displacement portion is the sleeve 102, and the detecting device has a guide post 404 engaged with the sleeve 102; the first end of the sleeve 102 is fixed to the pressing portion 103, and the second end of the sleeve 102 is engaged with the guide post 404. Initially, the sleeve is placed over the guide post and the solution reservoir and piercing element are brought into proximity with each other as the sleeve moves along the guide post.

In some embodiments, the displacement portion is a guide post, and the detection device is provided with a sleeve matched with the guide post; the first end of the guide post is fixed with the pressing part, and the second end of the guide post is matched with the sleeve. Initially, the guide post is placed on the sleeve and the guide post is moved along the sleeve to bring the solution reservoir and the piercing element into proximity with each other.

Blood sampler

The blood sampling device 30 is used to collect a sample, such as a blood sample.

In some embodiments, as shown in fig. 1 and 4, the test device is provided with a cartridge 30, which is a tubular structure. The hemostix comprises a blood collecting head, and a blood sample is collected by the blood collecting head. Preferably, one end of the blood collector is connected with a blood collecting head 301, the other end is a blood sucking pipe 302, and the blood collecting head is an air bag. The detection device is provided with an attachment portion 203 to which the blood sampling device is detachably attached. The mounting portion 203 is a sleeve fixed to the detection device, and one end of the sleeve is open. The blood sampling device is inserted into the sleeve from the opening. Alternatively, the mounting part is an elastic buckle fixed on the detection device, and the elastic buckle is provided with a bayonet allowing the blood collector to enter. The hemostix is clamped into the elastic buckle from the opening.

Puncture outfit

The puncture instrument 70 is a device for puncturing the skin or tissue to release blood. Lancers are commonly used lancing mechanisms, such as disposable safety lancets, and typically comprise a sharp needle for lancing tissue for bleeding. After the disposable safety blood taking needle is launched by the needle, the needle core is locked, so that the blood taking needle can be used only once, and the safety of a user can be guaranteed.

As shown in FIG. 9, in some embodiments, the test device has a receiving area for receiving the punctured tissue, and the puncture device is mounted in the receiving area with one end of the puncture device exposed and the exposed end of the puncture device containing the puncture needle. The lancet is used to pierce tissue to release blood.

In some embodiments, the puncture device includes a body clamped to the detection device and a needle containing cavity for containing the needle, and the needle containing cavity is exposed out of the detection device.

Casing of detection device

The housing provides a holding space for the penetrator, the solution reservoir and the detection channel.

As shown in fig. 7-9, in some preferred embodiments, the testing device has a housing with a solution reservoir 101, a lancing element 50, a lancet 70 and a test element 80 disposed therein, the lancet 70, the solution reservoir 101 and the lancing element 50 are integrated into the housing, and one end of the lancet 70 is exposed. Preferably, the solution reservoir 101 or the puncturing element 50 is mounted to the movable member 10, and the movable member 10, the solution reservoir 101 and the puncturing element 50 are located in a first region of the housing, the first region having a space in which the movable member is displaced. Preferably, the test element 80 includes at least a liquid suction region 801, a sample addition region 802, and a detection result region 803, the liquid suction region 801 of the test element 80 is located in a first region, a portion of the test element 80 other than the liquid suction region 801 and the sample addition region 802 is located in a second region of the housing, and the second region has a mounting space necessary for the test element 80. The liquid collecting part 402 of the detection channel is located in the first area, and the test part 405 of the detection channel is located in the second area. The solution is released and reaches the liquid collecting portion 402, and after the test element 80 absorbs the solution, the solution passes through the sample addition region 802 to dissolve the sample, and the sample reaches the detection result region 803 by capillary action and reacts with the reagent to display the result.

The first area satisfies the running space of the movable piece; the second region satisfies the mounting space of the test element. The first region needs to meet the space requirement for the movable member from the first position to the second position, and the height of the second region need only be able to accommodate the test element and the carrier. The second area just accommodates the mounted test element, and the freedom degrees of the test element in the upper, lower, left and right directions are all limited, so that the position of the test element is stable, and the accuracy of detection is ensured. Preferably, the lower plate is a flat plate, and the first region and the second region of the upper plate are transited by a slope.

As shown in fig. 7-9, in some preferred versions, the lance 70 is located at an end of the housing. Preferably, the puncture device 70 is located in the first region. The puncture outfit is positioned at the end part, so that the puncture outfit is convenient to use in blood sampling. As shown in fig. 1 and 4, in some preferred embodiments, the housing is provided with a movable member window 201, a display window 202 for the test results, and a puncture device window 205 for allowing the puncture device to be installed. The test device has a housing in which the piercing element 50, the solution reservoir 101 and the test channels are located, the housing being provided with a movable window 201, a display window 202 for the test results and a piercer window 205 allowing the piercer to be inserted. As shown in fig. 1 to 10 and 13, the housing includes an upper plate 20 and a lower plate 40, a movable member window 201 and a display window 202 provided on the upper plate, and a detection passage provided on the lower plate; when the puncture element 50 is provided on the movable element 10, the solution storage container 101 is provided on the lower plate 40, and when the solution storage container 101 is provided on the movable element 10, the puncture element 50 is provided on the lower plate 40.

As shown in fig. 10, in some embodiments, the upper plate is provided with a sample application window 204 for applying sample, and the sample application window 204 is located between the movable window 201 and the display window 202.

As shown in FIG. 7, in some embodiments, the piercer window 205 is provided in the upper plate 20, or the piercer window is formed by a cutout in the upper plate and a cutout in the lower plate.

Test element and detection channel

In some embodiments, the detection device further comprises a test element. The presence or quantity of an analyte in a blood sample can be detected by the test element. As shown in FIG. 15, the test element comprises a liquid suction end 801, a sample application region 802, and a detection result region 803, and the liquid suction end 801 communicates with the liquid trap portion 402 of the detection channel to suck up the solution discharged from the solution reservoir 101. The sample loading area 802 corresponds to the loading window 204 on the housing, and the detection result area 803 corresponds to the display window 202.

As shown in fig. 1 and 4, in some embodiments, the test channel is provided with a card slot component 403, and the test element 80 is detachably mounted in the card slot component 403. Preferably, the lower plate has a carrier 401, which is located in the detection channel, and the test element 80 is placed on the carrier 401. The tray 401 holds the test element 80 up to avoid soaking the test element with solution.

As shown in FIG. 6, in some embodiments, the movable member 10, the solution reservoir 101 and the lancing element 50 are located in a first region of the housing, the test element 80 is located in a second region of the housing, the liquid trap 402 of the detection channel is located in the first region, and the test part 405 of the detection channel is located in the second region. The solution is released and reaches the liquid collecting portion 402, and after the test element 80 absorbs the solution, the solution passes through the sample addition region 802 to dissolve the sample, and the sample reaches the detection result region 803 by capillary action and reacts with the reagent to display the result.

The height of the first region is greater than the height of the second region. The height refers to the distance from the lower plate 20 to the upper plate 40. The height of the first region is required to satisfy the space in which the movable member 10 operates, and the height of the second region is required only to be able to accommodate the test element and the carrier. The height of the second area just accommodates the mounted test element 80, and the freedom degrees of the test element 80 in the upper direction, the lower direction, the left direction and the right direction are all limited, so that the position of the test element 80 is stable, and the accuracy of detection is ensured. Preferably, the lower plate is a flat plate, and the first region and the second region of the upper plate are transited by a slope.

In some embodiments, as shown in FIGS. 7-9, the piercer is located at an end of the housing. The piercer is located in the first region. The puncture outfit is positioned at the end part, so that the puncture outfit is convenient to use in blood sampling.

Anti-misoperation cover

As shown in fig. 4-6 and 11, in some embodiments, the detection device further includes an anti-tamper cover 60, the anti-tamper cover 60 covering the movable member window 201. The misoperation prevention cover is a protection measure for preventing the movable part from operating due to misoperation to cause product failure. Preferably, the erroneous operation preventing cover is rotatably coupled to the housing. Preferably, the anti-misoperation cover 60 is connected with the housing through a rotary connecting piece, the rotary connecting piece comprises a connecting rod 601, one end of the connecting rod 601 is connected with the anti-misoperation cover 60, and the other end of the connecting rod is connected with the housing. Preferably, the both sides of casing set up the connecting rod respectively, and connecting rod one end is with the casing with decide, the other end with prevent that the maloperation lid rotates and be connected, perhaps, connecting rod one end rotates with the casing to be connected, the other end with prevent the maloperation lid fixed.

In another aspect, the present invention provides a method for detecting an analyte in a blood sample, the method comprising:

providing a test device comprising a test element 80, a solution reservoir 101, a piercing element 50 capable of piercing the reservoir, wherein the solution reservoir 101 has a first position and a second position in the test device; moving the solution reservoir 101 from a first position to a second position; during the movement, the piercing member 50 is allowed to pierce the solution reservoir 101, thereby releasing the solution in the solution reservoir 101.

At the moment, the solution storage is in a state of being separated from the detection device, after the sample application is finished, the containing device for containing the solution storage is sleeved on the channel structure, one end of the channel is aligned with one end of the solution containing cavity, which is sealed by the film, the solution storage is pushed to move from the first position to the first position, as the puncture element is positioned on the channel, the puncture structure is inserted into the sealing ports at two sides of the solution containing cavity and is further inserted into the solution containing cavity along with the channel, and the puncture structure is inserted deeply, so that the solution is forced to enter the channel from the opening of the channel, because the neck component is close to the opening of the channel, the solution entering through the opening of the channel also enters the neck, then flows into the sample application area, the solution flowing into the application area flows through the sample application area corresponding to the sample application hole, and the sample positioned on the sample application area is processed, thereby completing the test or assay.

The above method is directed to a blood sample, and when the blood sample is not the blood sample, the sample can be collected by a blood collector directly without a puncture device, such as saliva, feces, etc., as described above for the sample.

The utility model shown and described herein may be implemented in the absence of any element, limitation, or limitations specifically disclosed herein. The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, and it is recognized that various modifications are possible within the scope of the invention. It should therefore be understood that although the present invention has been specifically disclosed by various embodiments and optional features, modification and variation of the concepts herein described may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this invention as defined by the appended claims.

The contents of the articles, patents, patent applications, and all other documents and electronically available information described or cited herein are hereby incorporated by reference in their entirety to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. The applicants reserve the right to incorporate into this application any and all materials and information from any such articles, patents, patent applications, or other documents.

Claims (6)

1. Detection device with prevent maloperation, its characterized in that: the detection device comprises a shell, wherein a movable piece which is movably connected is arranged in the shell, and the puncture element or the solution storage device is fixed on the movable piece; when the movable piece moves, the solution storage device and the puncture element move relatively; the shell is provided with an anti-misoperation cover for covering the movable piece.

2. The detecting device with the misoperation prevention function as claimed in claim 1, wherein: the shell is provided with a movable part window, the movable part is arranged in the movable part window, and the misoperation prevention cover is provided with a flange which encloses the movable part window.

3. The detecting device with the misoperation prevention function as claimed in claim 1, wherein: prevent being connected by rotating the connecting piece between maloperation lid and the casing, rotate the connecting piece and include the connecting rod, connecting rod one end with prevent maloperation lid and be connected, the other end is connected with the casing.

4. A detection apparatus with anti-malfunction according to claim 3, characterized in that: the both sides of casing set up the connecting rod respectively, and connecting rod one end is fixed with the casing, the other end with prevent that the maloperation lid rotates to be connected, perhaps, connecting rod one end rotates with the casing to be connected, the other end with prevent the maloperation lid fixed.

5. The detecting device with the misoperation prevention function as claimed in claim 1, wherein: the movable piece comprises a pressing part and a displacement part, the displacement part is a sleeve, and the detection device is provided with a guide pillar matched with the sleeve; the first end of the sleeve is fixed with the pressing part, and the second end of the sleeve is matched with the guide pillar; or, the displacement portion is a guide pillar, and the detection device is provided with a sleeve matched with the guide pillar: the first end of the guide post is fixed with the pressing part, and the second end of the guide post is matched with the sleeve.

6. The detecting device with the misoperation prevention function as claimed in claim 1, wherein: the housing includes an upper plate and a lower plate, and the movable member window and the erroneous operation prevention cover are provided on the upper plate.