CN111265224A - Blood collection aid and method for separating a serum sample from whole blood - Google Patents

Blood collection aid and method for separating a serum sample from whole blood Download PDF

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Publication number
CN111265224A
CN111265224A CN202010076162.9A CN202010076162A CN111265224A CN 111265224 A CN111265224 A CN 111265224A CN 202010076162 A CN202010076162 A CN 202010076162A CN 111265224 A CN111265224 A CN 111265224A
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blood collection
blood
tube body
collection tube
liquid
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CN111265224B (en
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宋岩
张兰
韩斌如
刚婷婷
李冉
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Xuanwu Hospital
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Xuanwu Hospital
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150351Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150755Blood sample preparation for further analysis, e.g. by separating blood components or by mixing

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  • Life Sciences & Earth Sciences (AREA)
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Abstract

The invention relates to a lancing aid for separating a serum sample from whole blood, comprising at least: the blood collection tube body is used for storing collected liquid; a blood collection tube cap assembled to the blood collection tube body; and a blood collection dispensing assembly that controllably delivers liquid within the blood collection tube body to an exterior of the blood collection tube body by way of one end of the blood collection dispensing assembly being fittingly connectable to the blood collection tube cap, the blood collection dispensing assembly being configured to: the blood collection dispensing assembly is configured to cause the liquid stored in the blood collection tube body to be output in prescribed amounts in divided portions in such a manner that the gas from the outside of the blood collection tube body via the blood collection tube cap does not pass through the liquid stored in the blood collection tube body.

Description

Blood collection aid and method for separating a serum sample from whole blood
Technical Field
The present invention relates to the field of blood processing technology, and in particular to a blood collection aid and method for separating a serum sample from whole blood.
Background
Blood consists of blood plasma and blood cells, is closely related to each tissue and organ of the whole body in vivo through a circulatory system, participates in each function activity of the organism, and plays an important role in maintaining metabolism, function regulation and balance of internal and external environments of the organism. In pathological conditions, besides directly affecting blood, diseases in the blood system can also affect tissues and organs of the whole body, and the pathological changes of the tissues and organs can also directly or indirectly cause the change of blood components. Therefore, blood examination is one of the clinical examination items. The veins in the elbow fossa of most people are thick and shallow, and it is easy to find blood vessels and to make punctures. The skin sensitivity of the hand, elbow and fossa is lower than that of other parts, the pain feeling is weak during blood drawing, the wound is not easy to touch by foreign objects after blood drawing, and the wound can be prevented from being polluted after puncture and blood drawing. The venous blood volume is slow, the venous blood pressure is lower than the arterial blood pressure, the venous wall is thinner than the arterial wall, most veins are positioned on superficial skin, and the like. Venous blood sample collection refers to a method of drawing a blood sample from a vein. The veins selected for collecting the venous blood specimen usually include basilic vein, median elbow vein, dorsal vein of wrist and hand, great saphenous vein, small saphenous vein, dorsal vein of foot, external jugular vein (selected by infants), and femoral vein.
The venous puncture blood sampling and the venous transfusion are widely applied in clinical work, are mainly used for laboratory test and drug treatment, the venous blood sampling is used as a main means of the laboratory test and is also an important part of clinical nursing work, the trauma hemostasis is a key measure for rescuing in various accident sites and battlefields, and the blood vessel puncture needle is easy to move and puncture blood vessels due to the fact that multiple factors such as discomfort and limitation on the limb placement and the movement of a to-be-sampled object are caused in the long-time transfusion process, liquid is leaked out, red swelling or necrosis of the skin is caused, and the pain of a patient is increased. Particularly, in the blood sampling process, a subject to be sampled needs to expose local limbs, but in autumn and winter, the indoor temperature is low, so that the blood vessels are not full; usually, a simple cushion is only paved below the operation part or is directly placed on an operation table, so that the feeling is uncomfortable and the fixing is not easy; when children and critical patients carry out venous transfusion, devices such as clamping plates, binding bands and the like are needed to protect the transfusion, so that the patients are inconvenient; the traditional rubber tube tourniquet is thin, the contact area with the skin is small when the skin is tightly bound, the pain of a subject to be sampled is obvious, the skin is easy to loosen when dry, the pressure is difficult to master, subcutaneous extravasated blood and swelling are easy to cause during application, complications such as nerve paralysis and the like are easy to generate, and the work difficulty is increased.
The venous blood sampling method comprises the following operation steps: 1. the appropriate container is selected according to the purpose of the test. Checking the integrity of the container and attaching a check label to the outside of the container. 2. Checking the syringe: opening the package of the disposable syringe, holding the lower needle seat with the left hand and the needle cylinder with the right hand, tightly connecting the needle and the needle cylinder, aligning the inclined plane of the needle with the scale of the needle cylinder, and drawing the pintle to check whether the pintle is blocked or leaked. Finally, exhausting the air in the injector for later use. 3. Selecting veins: the subject to be sampled is taken out of the sitting position, and the forearm is horizontally stretched and placed on the table top pillow. The puncture site is exposed, and proper blood vessels are selected, such as the median elbow vein, the cephalic vein or the basilic vein. Order the patient to make a fist to fill the vein. 4. And (3) disinfection: the skin is first sterilized with a sterile cotton swab from the venipuncture site in the clockwise direction from the inside to the outside and allowed to dry. 5. And (3) pulse-pressure band ligation: the tourniquet is pricked at the position of 6CM on the puncture position, and the fist is clenched after the object to be sampled makes a fist repeatedly, so that the vein is fully exposed, and the puncture is convenient. 6. Puncturing after secondary disinfection: taking off the sterile cap of the needle head, fixing the lower end of the venipuncture part by using the thumb of the left hand, holding the syringe cylinder by using the thumb and the middle finger of the right hand, fixing the lower seat of the needle head by using the forefinger, enabling the inclined plane of the needle head and the scale of the syringe cylinder to be upward, and enabling the needle head and the blood vessel to be inserted in a direction of 15-30 degrees along the direction of the vein. After the blood returns, the needle head is inserted into a little bit in a homeopathic way so as to prevent the needle head from sliding out when blood is collected; but, deep insertion should not be done to avoid hematoma, and the tourniquet should be removed immediately. 7. Blood drawing: fixing the injector with the left hand, slowly pumping the inner core of the injector to the required blood volume, pressing the needle hole with a sterilized dry cotton ball, and quickly pulling out the injector when the object to be sampled is loose fist. The subject to be blood-sampled is pressed locally with a sterile dry cotton swab for 1-2 minutes. 8. Bleeding and mixing: the syringe needle is taken down, and the blood is slowly injected into the anticoagulation tube along the test tube wall to prevent hemolysis and foam generation. If the test tube with the anticoagulant exists, the test tube is slightly shaken to fully mix the anticoagulant with the blood, and the test tube plug is tightly covered for standby.
The invention relates to a vacuum blood sampling technology applied to venous blood sampling in the end of the 30 s of the 20 th century, which has the advantages of convenient clinical use, simple operation, totally closed test tubes, biological safety, easy repeated inspection of samples, easy storage of samples and the like, and is basically popularized and applied in China. Before the analysis of the laboratory vacuum blood collection tube specimen, a treatment process is generally needed, such as biochemical specimen, the steps of collection, centrifugation, cover opening, inspection, cover closing, preservation, disinfection and the like are carried out, the whole process is high in labor intensity, and the operation is complex, so that the process needs to be optimized, the efficiency is improved, and the labor intensity is reduced. The vacuum blood collection tube technology is the international advanced blood collection technology at present. The vacuum blood collection tube is technically characterized in that: (1) automatic metering without pumping back: because the blood sampling tube is artificially vacuumed, the blood sampling amount can be controlled by controlling the air pressure. Manual back-pumping measurement is not needed during operation; (2) the sterility degree is high, and the inspection interference is small: in order to keep the vacuum in the tube, the tube opening cover of the vacuum blood collection tube has good tightness, high sterility degree, small blood pollution probability and relatively small interference on the test result; (3) the blood composition is changed little by injecting blood into the tube once: the vacuum blood sampling method directly injects blood into the blood sampling tube, so that two processes of blood retention in the syringe needle cylinder and blood transfer from the needle cylinder to the blood sampling tube are omitted, repeated extrusion of blood is reduced, blood cells are less damaged, and the test result is more reliable.
At present, the blood collection tube has two types, namely a soft connection type bidirectional blood collection needle system (scalp vein bidirectional blood collection type) and a hard connection type bidirectional blood collection needle system (sleeve bidirectional blood collection type)), and one end of the blood collection tube is a puncture needle, and the other end of the blood collection tube is a puncture needle. Because the vacuum blood sampling method conforms to biological safety measures, is simple, convenient, accurate and reliable to operate and is generally applied to clinic, the vacuum blood sampling technology is an advanced blood sampling technology and is popular with hospitals and patients. The disposable vacuum blood sampling device is adopted to replace a disposable injector for blood sampling, and has the advantages of simple operation, less pain of patients, high working efficiency, no limit on blood sampling amount, operator protection, environmental pollution reduction and the like, so the disposable vacuum blood sampling device is more and more widely applied clinically.
In the actual operation of using the vacuum blood sampling device to collect samples, different from different biochemical detection requirements, different amounts of samples are collected according to different biochemical detection requirements, namely, the collected samples need to be subjected to quantitative subpackage treatment. For example, in a genetic testing laboratory, serum and plasma separation is a pre-step of many testing procedures, and a method for collecting and controlling the quality of a sample of DNA in fetal chromosomal aneuploidy testing is proposed in publication No. CN108486217A, which includes a sample collection step, specifically: collecting 5.0mL of peripheral blood of a pregnant woman by using the first blood collection tube, after the collection is finished, slightly reversing the blood collection tube for 4 times, putting the blood collection tube in a refrigerator at 4.0 ℃ in time, and carrying out plasma and serum separation within 8 hours; collecting 10.0mL of peripheral blood of a pregnant woman by using the second blood collection tube, slightly inverting the second blood collection tube for 10 times after collection, storing at normal temperature, and separating plasma and serum within 72 hours; precooling the low-speed centrifuge to 4.0 ℃, after the temperature is stable, putting the centrifuge into a second blood collection tube, centrifuging the centrifuge for 15 minutes, sucking supernatant plasma, transferring the supernatant plasma into a 2.0mL EP tube arranged on an ice box, and marking a corresponding sample number; precooling the high-speed centrifuge to 4.0 ℃, after the temperature is stable, putting the centrifuge into the 2.0mLEP tube obtained in the previous step, centrifuging for 10 minutes, enabling the gun head to face to a non-leukocyte precipitation position, sucking supernatant plasma on an ice box, subpackaging the supernatant plasma into 1.5mLEP tubes arranged on the ice box, transferring 400uL of plasma into each tube, marking the sample number and the number of the plasma tubes, and immediately putting the tubes into a refrigerator at the temperature of-20.0 ℃ or-80.0 ℃ for storage.
In the above-mentioned quantitative sample dispensing operation, the medical staff usually uses a first-opened cap and then a straw to suck the serum. However, the uncovering action of the vacuum blood collection tube in the medical laboratory is mostly manually completed by medical staff, no medical staff carries out the cover closing treatment on the patient sample which has completed the inspection work, and no instrument or equipment for carrying out the cover closing treatment on the patient sample which has completed the inspection work exists, and the operation of manually opening the blood collection tube cover has the following defects: 1. the labor is complicated; 2. the time consumption is long; 3. the biological safety risk is high, if the mouth of the test tube is broken to scratch an operator, the blood sample is splashed and aerosol is generated due to the sudden release of local negative pressure in the tube in the process of opening the cover, so that bacteria and viruses infect medical personnel; in addition, the labor intensity of opening the vacuum blood collection tube and closing the blood collection tube after the inspection work is finished is higher, and the biohazard to operators is more easily caused; 4. in the clinical test of the medicine, the blood sample needs to be subpackaged into a detection tube and a backup tube after being collected and centrifuged, and if blood is leaked in the air during blood sample separation, the blood is easy to be infected by bacteria, so that the blood can go bad, the detection result is inaccurate, the working difficulty is increased for medical personnel, and meanwhile, certain potential safety hazards are brought to patients.
In view of the above-mentioned problems in the current quantitative aliquoting process of specimens, the prior art has proposed many solutions, for example, a device and a method for separating serum or plasma from blood cells in a whole blood sample disclosed in patent document No. CN108601565A, which uses a cap with a reservoir so that blood cells are filled into the cap when a sample container is centrifuged, blood cells are also removed when the cap is removed, and serum or plasma is left in a sample tube, where it can be easily drawn by a pipette, which can reach all the way to the bottom of the sample tube, thereby minimizing the dead volume.
The above patent proposes a separation device which is different from the conventional structure of the existing blood sampling tube, but the separation device is not suitable for the existing conventional blood sampling tube because the existing blood sampling tube needs to be completely replaced, and the cost of the blood sample experiment is greatly increased; the quantitative sample split charging method adopted by the patent is still a method of fractional sampling by a pipette in the existing conventional sampling method, so that when the separation device proposed by the patent is actually used, the blood sample is always exposed to the external environment within the sampling time after the cover is opened; in addition, the minute amount of serum sample required for the blood sample experiment is difficult to accurately obtain by pipette.
Furthermore, on the one hand, due to the differences in understanding to the person skilled in the art; on the other hand, since the inventor has studied a lot of documents and patents when making the present invention, but the space is not limited to the details and contents listed in the above, however, the present invention is by no means free of the features of the prior art, but the present invention has been provided with all the features of the prior art, and the applicant reserves the right to increase the related prior art in the background.
Disclosure of Invention
To prior art not enough, if carry out sample ration partial shipment processing operation to vacuum blood sampling device, the heparin tube is uncapped insecurely, the loaded down with trivial details problem of sampling operation, a large amount of solutions of focusing on solving the problem of how safely uncapping have been proposed among the prior art, for example, the structure is complicated, the supporting uncapping device that the operation requires the precision to be high and specially adapt to the heparin tube lid of this uncapping device, above-mentioned solution inevitably has improved blood specimen cost and operation procedure complexity, and lead to the serum sample after uncapping to expose under the external environment for a long time. Different from the prior art, the invention provides a solution for obtaining a blood sample without opening a cover and preventing adverse adsorption between gas and liquid on the basis of meeting the fractional output requirement and the quantitative requirement of sample quantitative subpackaging processing operation, and the solution aims to improve the existing sampling operation device and process to a small extent to provide a blood sampling auxiliary device and a method for separating a serum sample from whole blood. This blood sampling auxiliary device combines together with current conventional heparin tube and uses, need not to abandon current conventional heparin tube, therefore has greatly reduced the required cost of this experiment of blood sample.
Blood collection aid for separating a serum sample from whole blood, comprising at least: the blood collection tube body is used for storing collected liquid; a blood collection tube cap assembled to the blood collection tube body; and a blood collection separate-charging unit that can controllably convey the liquid inside the blood collection tube body to the outside of the blood collection tube body by way of one end of the blood collection separate-charging unit being fittingly connected to the blood collection tube cap, the blood collection separate-charging unit being configured to cause the liquid stored in the blood collection tube body to be discharged in prescribed amounts in a divided manner in such a manner that the gas coming from the outside of the blood collection tube body via the blood collection tube cap does not pass through the liquid stored in the blood collection tube body.
Preferably, the blood collection racking assembly is configured to: when the blood sampling tube body is in a first placing state, the opening degree of the blood sampling tube cover is limited, the blood sampling tube cover is in adaptive connection, and one end of a liquid channel and one end of a gas channel on the blood sampling sub-packaging assembly are respectively communicated with the inside of the blood sampling tube body. Or, when the blood collection tube body is in a second placement state opposite to the first placement state, a predetermined amount of gas is caused to pass through the gas passage and enter the interior of the blood collection tube body so as not to cause adsorption with the liquid, so that the predetermined amount of liquid is dispensed to the exterior of the blood collection tube body.
According to a preferred embodiment, a hollow plate is provided inside the blood collection tube body, the hollow plate being configured to: and allowing the gas channel to be communicated with the inner cavity of the blood sampling sub-packaging assembly when the blood sampling sub-packaging assembly is in fit connection with the blood sampling tube cap. And such that the first end of the gas channel continues to extend along the inner cavity of the hollow plate in such a manner that gas coming from outside the cartridge tube body via the cartridge cap does not pass through the liquid stored in the cartridge tube body, and communicates with the inside of the cartridge tube body at the open end of the hollow plate located on a different imaginary horizontal plane from the first end.
Preferably, the hollow plate is movably fitted to an inner wall of the cartridge body near the cartridge cap. The hollow plate is configured to allow the gas channel to communicate with the inner cavity of the blood collection dispensing assembly when the blood collection dispensing assembly is mated with the blood collection tube cap. The hollow plate is configured such that the first end of the gas passage continues along the interior cavity of the hollow plate. The hollow plate is configured to communicate with the interior of the blood collection tube body at an open end of the hollow plate located on a different imaginary horizontal plane from the first end. The hollow plate is configured to move in a direction away from the cartridge cap in response to an amount of displacement of the gas channel relative to the cartridge cap within the cartridge cap, so that the open end of the hollow plate is located above a liquid level of the liquid when the cartridge cap is in the second placement state and the liquid is located above the cartridge cap.
According to a preferred embodiment, the hollow plate is assembled to the blood collection tube body before the blood collection operation is performed by using the blood collection tube body, wherein both ends of at least one first through hole provided in the plate body of the hollow plate are respectively communicated with the inside of the blood collection tube body and isolated from the inner cavity of the hollow plate. When the blood sampling tube body is utilized for blood sampling operation and/or the blood sampling tube body is switched to the second placing state, liquid entering the blood sampling tube body flows freely inside the blood sampling tube body through at least one first through hole and covers the inner wall of the blood sampling tube cover.
Preferably, the hollow plate is communicated with the inside of the blood collection tube body and isolated from the inner cavity of the hollow plate through two ends of at least one first through hole formed in the plate body of the hollow plate, so that when the blood collection tube body is utilized for blood collection operation and/or when the blood collection tube body is switched to the second placement state, liquid entering the blood collection tube body passes through at least one first through hole and freely flows inside the blood collection tube body, or gas entering the inner cavity of the blood collection tube body through the gas passage is limited to flow along the extending direction of the inner cavity, or solid insoluble in the liquid in the blood collection tube body is limited to be in a single-side area determined by the hollow plate.
According to a preferred embodiment, the blood collection assisting device at least comprises a pressurizing gap which is an area for providing a specified amount of gas to the gas channel when the blood collection sub-assembly is fittingly connected with the blood collection tube cover. Wherein, come from the outside gas admission of heparin tube body under the inside circumstances of heparin tube body, be located atmospheric pressure in the pressurization clearance and being located the atmospheric pressure in the heparin tube body can reach the equilibrium fast.
Preferably, the pressurizing gap is located between the blood collection sub-assembly and the blood collection tube cap, which are hermetically connected to each other. The gas passage is attached to the blood collection and dispensing unit so that a second end portion thereof remote from the blood collection tube body is open in the pressurizing gap. The liquid channel is assembled on the blood sampling sub-packaging component in a mode that two ends of the liquid channel respectively penetrate through the pressurizing gap. Thereby, the gas delivered to the pressurizing gap is input into the blood collection tube body through the gas passage and the hollow plate. When the gas to be introduced enters the inside of the blood collection tube body without forming an adsorption effect with the liquid, the pressure in the pressurizing gap and the pressure in the blood collection tube body can be quickly balanced.
According to a preferred embodiment, the lancing aid comprises at least a liquid level monitoring assembly, wherein the lancing aid is configured to: based on a specified amount of gas input along the gas channel and a liquid flow rate between different liquid level positions monitored by the liquid level monitoring assembly at different times. It can be determined whether the flow rate of the liquid dispensed to the outside of the cartridge body satisfies a prescribed amount.
Preferably, the liquid level monitoring assembly is configured to be fixed relative to the blood collection tube body for monitoring the position of the liquid level of the liquid inside the blood collection tube body. The liquid level monitoring assembly monitors a first liquid level position at a first moment and monitors a second liquid level position at a second moment, and determines whether the liquid flow distributed to the outside of the blood collection tube body meets a specified amount by combining the liquid flow between the first liquid level position and the second liquid level position and the specified amount of gas input along the gas channel.
According to a preferred embodiment, the lancing auxiliary device is configured to: and acquiring a third liquid level position and a fourth liquid level position acquired by the blood sampling auxiliary device when the blood sampling tube body is in the second placing state, and determining the total amount of the liquid acquired by using the blood sampling tube body so that a user can determine at least one distribution mode of the liquid based on the total amount of the liquid.
Preferably, the blood collection assisting device is configured to determine a total amount of the liquid collected by the blood collection tube body based on a height difference between the third liquid level position and the fourth liquid level position and a cross-sectional area of the blood collection tube body so that a user can determine at least one distribution manner of the liquid based on the total amount of the liquid.
According to a preferred embodiment, a part of the plate surface of the hollow plate extends in a direction away from the cartridge cap so that the inner cavity of the hollow plate has an open end extending in a direction of the central axis of the cartridge tube and located on a different imaginary horizontal plane from the plate surface of the hollow plate.
Preferably, the gas passage is configured to allow gas input along the gas pressure gap to pass therethrough while isolating liquid inside the blood collection tube body, so that the liquid inside the blood collection tube body can be output to the outside of the blood collection tube body only by a prescribed amount through the liquid passage.
Blood collection aid system for separating a serum sample from whole blood, comprising at least: the blood collection tube body is used for storing collected liquid; a blood collection tube cap assembled to the blood collection tube body; and a blood collection sub-assembly that controllably conveys the liquid in the blood collection tube body to an outside of the blood collection tube body by way of fitting one end thereof to the blood collection tube cap, the blood collection assist system being configured to cause the liquid stored in the blood collection tube body to be outputted in specified amounts in a manner such that the gas from the outside of the blood collection tube body via the blood collection tube cap does not pass through the liquid stored in the blood collection tube body when the blood collection sub-assembly forms an area for supplying a specified amount of gas to the gas passage by way of fitting the blood collection tube cap to the blood collection tube cap.
According to a preferred embodiment, the blood collection aid system comprises at least a hollow plate provided within the blood collection tube body, the hollow plate being configured to: and allowing the gas channel to be communicated with the inner cavity of the blood sampling sub-packaging assembly when the blood sampling sub-packaging assembly is in fit connection with the blood sampling tube cap. And such that the first end of the gas channel continues to extend along the interior cavity of the hollow plate in a manner such that gas from outside the cartridge tube body via the cartridge cap does not pass through the liquid stored in the cartridge tube body.
According to a preferred embodiment, the lancing auxiliary system comprises at least a liquid level monitoring assembly, wherein the lancing auxiliary system is configured to monitor the liquid level between different liquid level positions at different times based on a specified amount of gas input along the gas channel and the liquid flow rate monitored by the liquid level monitoring assembly. It can be determined whether the flow rate of the liquid dispensed to the outside of the cartridge body satisfies a prescribed amount.
The blood collection auxiliary device and the method for separating the serum sample from the whole blood provided by the invention have at least the following beneficial technical effects:
the invention provides a solution for obtaining a blood sample without opening a cover, and the auxiliary blood sampling device provided by the invention can be used for subpackaging a serum sample in a blood sampling tube by simply assembling after the blood sampling is finished through arranging a blood sampling subpackaging assembly matched with the blood sampling tube in the conventional structure without changing the conventional structure of the blood sampling tube and a tube cover, so that the operation process is simple, the cost of the blood sample is low, and the exposure time of the serum sample exposed in the external environment is greatly shortened while the cover is not opened; moreover, the hollow plate which is matched with the blood sampling and subpackaging assembly for providing gas is arranged, so that the possibility of forming adsorption between gas and liquid can be effectively avoided, and the reliable sampling efficiency and the sampling amount accuracy are ensured.
Drawings
FIG. 1 is a simplified cross-sectional schematic view of a preferred embodiment of a blood collection aid provided in accordance with the present invention;
FIG. 2 is a simplified schematic diagram of the hollow plate provided by the present invention;
FIG. 3 is a schematic structural view of a preferred connection between the gas channel and the hollow plate provided by the present invention;
FIG. 4 is a simplified module connection diagram of an auxiliary operating device according to a preferred embodiment of the present invention; and
FIG. 5 is a schematic view showing a simplified structural connection relationship of a blood collection support pad according to a preferred embodiment of the present invention.
List of reference numerals
1: blood collection tube body 2: blood collection tube cap 3: blood sampling sub-packaging assembly
4: gas passage 5: the liquid passage 6: hollow plate
7: the pressing gap 8: liquid level monitoring assembly 9: first through hole
10: through hole 11: first slide 12: second sliding part
13: solid component layer 14: liquid component layer 15: gas layer
16: inert separation glue layer 101: blood collection support pad 102: blood vessel visualization device
103: the central processing module 104: support plane 105: airbag module
106: tourniquet
Detailed Description
The present invention will be described in detail with reference to the accompanying drawings.
Example 1
As shown in FIG. 1, the present invention provides a lancing aid for separating a serum sample from whole blood.
This blood sampling auxiliary device includes blood sampling tube body 1 and blood sampling tube cap 2.
Above-mentioned heparin tube body 1 is the heparin tube structure most commonly used among the prior art with heparin tube cap 2:
the blood collection tube body 1 is used for storing collected liquid.
The blood collection tube cover 2 is assembled on the end part of the blood collection tube body 1, so that the inside of the blood collection tube body is relatively sealed.
Blood sampling tube lid 2 with the detachable mode assemble extremely on the blood sampling tube body 1, can be through locating the puncture layer of 2 tops of blood sampling tube lid to gather the serum sample in the blood sampling tube body 1.
The pierceable layer is a common pharmaceutical grade butyl rubber plug. The crown part of the rubber plug of the butyl rubber plug is provided with a thinner part (the thickness of the thinner part is generally 2.7 mm-3 mm) for the needle body to smoothly puncture the rubber plug.
The technical problems and the points of the present invention are explained in detail below:
the collected blood samples are transferred from the blood collection tube to different blood sample vessels in multiple times. In the conventional blood sample transfer operation, the operator usually removes the blood collection tube cap 2 from the top of the blood collection tube body 1 and then transfers the blood sample. For the existing blood sample transfer procedure:
on the one hand, because the inside of the heparin tube body 1 after gathering good blood sample is relative encapsulated situation, heparin tube body 1 is inside easily to produce certain atmospheric pressure, is opening heparin tube lid 2 in the twinkling of an eye difficult to avoid probably having the blood sample of infectious virus and splashes out, and the long and thin heparin tube body 1 of glass system appears the damage easily under the operation of powerful uncapping simultaneously.
A large amount of heparin tube solutions that carry out the improvement to above-mentioned not enough have been proposed among the prior art, and its solution is on the way to solve the problem of uncapping safely, has proposed the supporting uncapping device that the structure is complicated, the operation requires the precision to be high and has specially adapted in heparin tube lid 2 of this uncapping device, and it has greatly improved blood specimen cost and operation flow complexity to require the serum sample after uncapping to expose under the external environment for a long time.
Different from the prior art, the blood sampling auxiliary device provided by the invention is based on a solution scheme that a blood sample can be obtained without opening a cover, the blood sampling auxiliary device provided by the invention can be used for subpackaging a serum sample in a blood sampling tube by simply assembling after the blood sampling is finished through arranging the blood sampling subpackaging component 3 matched with the blood sampling tube in the conventional structure without changing the conventional structure of the blood sampling tube and a tube cover, the operation process is simple, the cost is low, and the exposure time of the serum sample in the external environment is greatly shortened while the cover is not opened.
On the other hand, the above-mentioned related uncapping device with a complex structure and high operation precision and the blood collection tube cap 2 specially adapted to the uncapping device in the prior art do not consider the problem that the blood sample possibly containing infectious virus splashes after uncapping. This is because, in the subsequent sampling process, in the conventional sampling method, for example, the method of pouring type sampling, the operation precision is higher than that of the safety cap removal, and it is also difficult to avoid the blood sample possibly carrying infectious virus from splashing;
in addition, for example, in the method of taking samples by pipette, the solid substance at the bottom of the blood collection tube may be sucked by the pipette when the pipette is inserted too deeply or a sufficient amount of serum sample cannot be sucked when the pipette is inserted too shallowly, and the required trace amount of serum sample is difficult to be accurately obtained by the pipette.
Different from the prior art, the invention provides a solution for sampling in a grading manner based on increasing the internal pressure of the blood sampling tube body 1, pressurized gas is input into the blood sampling tube body 1 through the blood sampling sub-assembly component 3, the sampling amount of an output serum sample can be indirectly controlled by controlling the input amount of the pressurized gas, and meanwhile, the problem that the extending depth of a sampler is difficult to control in the prior art is avoided because liquid and solid are isolated from each other during sampling.
Further, although the above-mentioned technical solutions of the pressurized gas driven quantitative discharge of liquid belong to the prior art in the same or corresponding fields, they cannot be directly combined with the blood collection tubes provided in the art.
This is because when the technical scheme that the pressurized gas drives the liquid to be quantitatively discharged is directly combined to the conventional blood sampling tube, the pressurized gas input into the liquid rises upwards to the position above the liquid surface in the form of bubbles, but in the process, when the pressure inside the device is increased in the later stage of pressurization, a plurality of bubbles input through the liquid are also difficult to float upwards, the floating speed of the bubbles is gradually reduced, and the retention time of the bubbles in the liquid is prolonged, so that not only is the sampling and packaging time prolonged, but also the increase of the pressure inside the device causes the particle size distribution of the bubbles to be gradually narrowed, the time for adsorption between the bubbles and the liquid phase is prolonged, the gas solubility is increased, and the gas included in the liquid is possibly conveyed to the outside of the device along with the liquid, and in this case, the obtained sampling amount is difficult to ensure the accuracy.
Based on the technical problems provided by the invention, the invention provides the hollow plate 6 which is matched with the blood sampling sub-packaging assembly 3 for providing gas, the arrangement of the hollow plate 6 can not only effectively prevent the possibility of forming adsorption between gas and liquid, but also prove that the sampling efficiency is effectively improved and the original sampling time can be shortened by more than 45% after the inventor practices and compares a large number of comparison experiment groups, and the accuracy of the optimal liquid sampling quantity which can reach 98.5% is proved.
The structure and the installation method of the blood collecting sub-package assembly 3 provided by the invention are explained in detail as follows:
preferably, the blood collecting and dispensing assembly 3 can controllably convey the liquid in the blood collecting tube body 1 to the outside of the blood collecting tube body 1 by means of one end of the blood collecting and dispensing assembly being fittingly connected to the blood collecting tube cap 2. Here, "controllable" means that the amount of liquid to be discharged from the blood collection tube body 1 is controllable. The "controllable mode" may be based on the liquid level information collected by the liquid level monitoring module 8 disposed outside the blood collection tube body 1, or may be based on the relevant parameters of the pressurized gas delivered to the inside of the blood collection tube body 1.
The invention controls the sampling amount by mutually verifying the liquid level information and the related parameters, and on the other hand, because the pressurized gas does not enter the gas layer 15 in the blood sampling tube body 1 through the liquid, the inaccuracy of the liquid level information of the liquid mixed with part of the pressurized gas is avoided, therefore, the blood sampling auxiliary device provided by the invention not only changes the existing sampling mode and solves the problem that the external environment is polluted by the blood possibly carrying infectious viruses, but also provides a blood sampling auxiliary method with high accuracy for sampling.
Preferably, when the blood collection tube body 1 is in the first placement state, the blood collection dispensing set 3 is fittingly connected to the blood collection tube cap 2 so as to limit the degree of opening of the blood collection tube cap 2, and one end of the liquid channel 5 and one end of the gas channel 4 located on the blood collection dispensing set 3 are respectively communicated with the inside of the blood collection tube body 1, or when the blood collection tube body 1 is in the second placement state opposite to the first placement state, a predetermined amount of gas is allowed to pass through the gas channel 4 and enter the inside of the blood collection tube body 1 so as not to form an adsorption effect with the liquid, so that the predetermined amount of liquid is distributed to the outside of the blood collection tube body 1. The "first placement state" refers to a placement state (not shown) in which the blood collection tube cap 2 is positioned above the blood collection tube body 1. The "second placement state" refers to a placement state in which the blood collection tube cap 2 is positioned below the blood collection tube body 1 as shown in fig. 1. "limiting the degree of opening of the blood collection tube cap 2" means that the area of the open end surface of the blood collection tube cap 2 exposed to the external environment is reduced, that is, the blood collection unit 3 covers the open end surface. The 'adaptive connection' refers to a detachable connection mode such as threaded connection or clamping connection, and the sealing performance can be further enhanced by arranging a rubber gasket between the blood sampling sub-packaging assembly 3 and the blood sampling tube cap 2.
The following detailed description is made of the structure and installation manner of the hollow plate 6 different from the prior art provided by the present invention:
first, as shown in fig. 2, regarding the structural schematic diagram of the hollow plate 6, from left to right, the first schematic diagram is a top view of the hollow plate 6, the second schematic diagram is a bottom view of the hollow plate 6, and the third schematic diagram is a cross-sectional view of the hollow plate 6 in the direction of a-a in fig. 1.
In contrast, as shown in fig. 3, the gas passage 4 is abutted against the hollow plate 6, and the gas passage 4 is communicated with the inner cavity of the hollow plate 6, so that the gas passage 4 and the hollow plate 6 are connected in a preferable manner. The solid arrows indicate the movement directions of the components (the gas passage 4, the first slider 11, and the second slider 12 shown in the figure) on the side of the arrows when the gas passage 4 abuts against the hollow plate 6. Wherein the dashed arrows indicate the liquid flow direction inside the gas channel 4 and the liquid flow direction inside the second slider 12 when the gas channel 4 is abutted to the hollow plate 6 and the gas channel 4 is communicated with the inner cavity of the hollow plate 6. Wherein the arc-shaped dotted line between the gas passage 4 and the second slider 12 indicates the internal communication therebetween.
Preferably, the hollow plate 6 is a cylinder that matches the shape of the inner wall of the blood collection tube body 1. The hollow plate 6 can slide up and down relative to the inner wall of the blood collection tube body 1 under the action of external force. For ease of understanding, the hollow plate 6 is considered herein as a cylinder, and is defined wherein the hollow plate 6 has a cylindrical bottom surface and a cylindrical side surface.
Further, for the cylinder bottom surface perpendicular to the penetrating direction of the blood collection tube body 1 on the hollow plate 6, at least one first through hole 9 is opened on the central region of the cylinder bottom surface, and the first through hole 9 communicates the inside and the outside of the cylinder. Therefore, before the blood sampling device is actually used for blood sampling, the blood sampling tube and the vein blood sampling needle are combined for blood sampling, and the puncturing end of the bidirectional blood sampling needle pierces the tube cover 2 of the blood sampling tube, penetrates through the first through hole 9 formed in the bottom surface of the cylinder body of the hollow plate 6 and is placed in the tube body 1 of the blood sampling tube; similarly, when the bidirectional blood collection needle is taken out after the blood collection, the plug end thereof exits the first through hole 9 and the blood collection tube cap 2 and is separated from the inside of the blood collection tube body 1, i.e., the arrangement of the hollow plate 6 does not affect the blood collection process.
Further preferably, for the first through hole 9 opened on the bottom surface of the cylinder of the hollow plate 6, the inner wall of the first through hole 9 is provided with a second sliding part 12 and a first sliding part 11, and both sliding parts are elastically and slidably connected to the inner wall of the first through hole 9. The sliding direction of the first slider 11 is parallel to the penetrating direction of the first through hole 9, and the sliding direction of the second slider 12 is perpendicular to the penetrating direction of the first through hole 9.
When no external force is applied to the first slider 11, the first slider 11 is positioned at the side end surface position of the second slider 12 by the corresponding spring in the compressed state, and the second slider 12 abuts against the side end surface outer wall of the second slider 12 by the corresponding spring in the compressed state.
After penetrating the gas channel 4 into the blood collection tube cap 2 and entering the interior of the blood collection tube body 1, the blood collection subpackaging assembly 3 is gradually pushed, so that the free end of the gas channel 4 is abutted to the first sliding part 11 and is continuously pushed, the free end pushes the first sliding part 11 to move until the first sliding part 11 and the second sliding part 12 are separated from the abutting relation, the second sliding part 12 moves towards one side in a corresponding manner that the spring action in a compression state is released and is abutted to the outer wall of the gas channel 4, and the relatively fixed position relation between the gas channel 4 and the hollow plate 6 is limited. Preferably, the second slider 12 is provided with an elastic rubber pad on the outer edge thereof near the open end of the gas passage 4. The provision of a resilient rubber pad is advantageous to improve the relative tightness of the gas passage between the second slider 12 and the gas channel 4 and to limit the tendency to slip between the two.
Preferably, the side wall of the free end of the gas channel 4 is provided with an opening communicated with the inside of the gas channel, and the second sliding member 12 is penetrated in front and back, so that the gas channel 4 can convey gas into the cavity of the hollow plate 6 through the second sliding member 12 penetrated in front and back, and the gas enters the gas layer 15 in the blood collection tube body 1 sequentially through the cavity on the bottom surface of the cylinder, the cavity on the side surface of the cylinder, and the open end on the side surface of the cylinder.
Still more preferably, the outer wall of the blood collection tube body 1 is provided with a scale mark for identifying the installation position, and the hollow plate 6 is installed inside the blood collection tube body 1 in such a manner that the position of the first slider 11 is aligned with the scale mark. Similarly, the blood collection dispensing unit 3 is attached to the blood collection tube cap 2 so that the scale lines on the outer wall of the blood collection tube body 1 are aligned with the scale lines on the outer wall of the blood collection tube body. Therefore, the gas passage 4 on the blood collecting and sub-packaging assembly 3 can be aligned with the first sliding part 11 in the hollow plate 6 to complete the relative fixing process between the gas passage 4 and the hollow plate 6.
The technical characteristics and the related principles which are proposed above are further specifically explained:
after centrifugation of the collected blood sample, the inert separation gel inside the blood collection tube body 1 can completely separate the liquid component (serum or plasma) and the solid component (red blood cells, white blood cells, platelets, fibrin, etc.) in the blood, and the inert separation gel is interposed between the solid component and the liquid component based on its physical properties. After a period of standing time, the separating gel solidifies to form a barrier that accumulates over the solid components.
Even if the blood collection tube body 1 is inverted at this time, the solid component of the blood collection tube body 1 after being inverted as shown in fig. 1 is prevented from moving by the barrier and can only be held at the bottom of the blood collection tube body 1, and as shown in fig. 1, the layer located at the topmost end of the tube body is the solid component layer 13, the inert separation layer 16 located below the solid component layer 13, the liquid component layer 14 located at the bottommost end of the tube body, and the layer located between the inert separation layer 16 and the liquid component layer 14 is the gas layer 15.
Preferably, when the blood collection tube body 1 is in the first placement state of being placed vertically, the blood collection sub-assembly 3 is adapted to be sealingly connected to the blood collection tube cap 2 so as to limit the opening degree of the blood collection tube cap 2. And one end of a liquid channel 5 and one end of a gas channel 4 which are positioned on the blood sampling sub-packaging assembly 3 are respectively communicated with the interior of the blood sampling tube body 1. The first end of the gas channel 4 extending into the blood collection tube body 1 is communicated with the inner cavity of the hollow plate 6. The first end of the gas channel 4 continues along the inner cavity of the hollow plate 6.
Preferably, the first end of the gas channel 4 may be flush with the end of the liquid channel 5 on the side of the first end. In this case, the hollow plate 6 is disposed at a position close to the cartridge cap 2 and the plate edge thereof continues along the tube wall. That is, the side surface of the hollow plate 6 abuts against the tube wall of the blood collection tube body 1 and extends upward from the bottom surface of the tube body along the tube wall.
The liquid passage 5 is communicated with the liquid inside the blood collection tube body 1 through a first through hole 9 formed in the hollow plate 6, and the gas passage 4 is communicated with the inner cavity of the hollow plate 6 through an opening formed in the hollow plate 6.
Preferably, the first end of the gas passage 4 may be higher than the end of the liquid passage 5 on the side of the first end. In this case, since the gas passage 4 is long, the hollow plate 6 will be further pushed to move away from the blood collection tube cap 2 after the gas passage 4 abuts against the hollow plate 6. The existing vacuum blood collection tube specially used for collecting serum samples usually has a blood collection volume of 3ml to 5ml and a specification of 13 x 75mm or 13 x 100mm, that is, hollow plates 6 with different specifications can be adopted for the vacuum blood collection tube based on the existing specification.
Preferably, a pressurizing gap 7 for supplying a predetermined amount of gas to the gas channel 4 is formed when the blood collection dispensing assembly 3 is fittingly connected to the blood collection tube cap 2. Thus, the gas outside the blood collection tube body 1 passes through the pressurizing gap 7 and then enters the gas channel 4.
On one hand, when the gas channel 4 penetrates through the blood collection tube cap 2 and is placed in the liquid inside the blood collection tube body 1, part of the liquid may flow out of the inside of the blood collection tube body 1 along the inside of the gas channel 4, and the part of the liquid directly enters the pressurizing gap 7 and does not flow out to pollute the operating environment;
on the other hand, the setting of pressurization clearance 7 can simply indirectly detect the atmospheric pressure of gas layer 15 in blood sampling tube body 1 and cushioned the atmospheric pressure rate of change when pressurization or pressure release, has avoided gaseous direct transport and can't effectively control the problem of its atmospheric pressure rate of change of gas layer 15 in blood sampling tube body 1.
After the gas channel 4 is abutted to the hollow plate 6 and the gas channel 4 and the inner cavity of the hollow plate 6 form a passage, the blood collection tube body 1 is inverted. The first through holes 9 provided in the hollow plate 6 facilitate the flow of the liquid and further obstruct the solids above the liquid that may fall off in a pressurized environment. At this time, the liquid and the solid are respectively located at both ends of the blood collection tube body 1, and as shown in fig. 1, the open end of the hollow plate 6 is placed in the region of the gas layer 15 above the liquid surface of the liquid. A predetermined amount of gas is allowed to pass through the gas passage 4 and the inner cavity of the hollow plate 6 in order along the pressurizing gap 7 and enter the inside of the blood collection tube body 1, and the gas can enter the gas layer 15 inside the tube body without passing through a liquid, that is, the gas and the liquid do not form an adsorption action therebetween, and thus the predetermined amount of liquid can be distributed to the outside of the blood collection tube body 1.
Example 2
In this embodiment, an auxiliary operation device of the non-contact blood vessel visualization apparatus 102 is provided, and based on the blood collection tube body provided in embodiment 1, further detailed description is provided for the blood collection operation performed by the auxiliary operation device, and the same components as those in embodiment 1 are not repeated in this embodiment.
As shown in fig. 4, the auxiliary operation device with the non-contact blood vessel visualization device 102 at least comprises a blood collection support pad 101, a blood vessel visualization device 102 and a central processing module 103.
As shown in fig. 5, the blood collection support pad 101 is used for supporting and fixing the arm of the blood collection subject. At least one supporting plane 104 is arranged on the blood sampling supporting pad 101. The relative spatial position between at least one support plane 104 of the blood collection support pad 101 is determined by medical information. The height parameter in the relative spatial position and the link distance parameter between the two support planes 104 can be adjusted based on the population of different heights.
A blood vessel visualization device 102 is fitted over the blood collection support pad 101. The vessel visualization device 102 is used in conjunction with the blood collection support pad 101 to provide hemodynamic monitoring of the projection of subsurface structures onto the surface of a subject. The blood collection support pad 101 is mounted on a platform plane below the blood vessel visualization device 102. The blood collection support pad 101 can move back and forth relative to the platform plane. In actual use, the blood vessel visualization device 102 is installed at the top position of the arched blood collection window. Hemodynamic monitoring includes at least monitoring of blood flow. Blood flow (blood flow) is the volume of blood passing through a section of a blood vessel per unit time, also known as the volume velocity. This is in fact the blood flow rate, which depends on the pressure difference across the blood vessel and the resistance of the blood vessel to the blood flow. The measurement of blood flow rate is of practical value for examining cardiovascular function, diagnosing vascular disease, and the like. Slow blood flow indicates insufficient blood pressure or too much vascular resistance. There are many conventional blood flow measurement methods, such as an ultrasonic doppler method, a laser doppler method, a nuclear magnetic resonance method, and the like. The blood vessel visualization device 102 utilizes that when infrared light irradiates human tissues, the hemoglobin removed in the vein has a more obvious absorption effect on the infrared light than surrounding tissues, and a very obvious vein image can be formed when the vein image is shot by an infrared camera lens, and the vein image is converted by a special software and hardware image processing system and then is back projected to the surface of the skin by visible light to form a visible image of the vein, so as to assist in positioning and displaying the vein. Based on the above principle, the blood vessel visualization device 102 can display subcutaneous vein which is not easy to see, and is used for auxiliary positioning display of superficial vein at the back of hand, the back of foot, the elbow and the wrist, the scalp and the like. Through the blood vessel visualization device 102, the accuracy of vein positioning and the success rate of vein puncture can be improved, and the pain of the object to be sampled and the contradiction between doctors and patients can be reduced. The blood vessel visualization apparatus 102 is currently capable of observing the direction of blood flow and qualitatively evaluating the blood flow rate, but no auxiliary device for quantitatively evaluating the blood flow through the blood vessel visualization apparatus 102 is available. In the actual venous blood collection process assisted by the blood vessel visualization device 102, a medical worker usually needs to strictly monitor whether a selected blood vessel meets a puncture condition, particularly in a tumor drug injection process, needs to avoid damage to human tissues or mechanical damage caused by leakage of liquid medicine or discontinuous blockage of the blood vessel, needs to press one end of the blood vessel in a mapping region of the blood vessel visualization device 102 and then release the end, and under the operation, the blood vessel is cut off at one end and then recovers to flow, so that qualitative evaluation is realized. The auxiliary operation device provided by the invention realizes quantitative assessment of the blood flow by using the simple operation, and the quantitative assessment process provides a method for quantitatively assessing the blood flow by combining the high-definition imaging characteristic of the blood vessel visualization device 102 and the hemodynamic analysis of the simple operation. The personalized quantitative assessment of the blood flow is to assist the medical staff in blood sampling operations, in particular to assist the medical staff who are not skilled in the operation and who are not able to make clear the timing of the release of the tourniquet, or in particular to assist the medical staff who are not skilled in the operation and who are not able to make clear the timing of the stop of the blood sampling operations.
According to a preferred embodiment, the central processing module 103 interacts with hospital medical systems to assist medical personnel in performing blood collection operations based at least on their blood collection image analysis of image information collected by the blood vessel visualization device 102 providing hemodynamic monitoring by controlling the way the blood collection support pad 101 is used in cooperation with the blood vessel visualization device 102 in determining medical information of a next blood collection subject.
According to a preferred embodiment, the blood collection image analysis is based on image information acquired by the vessel visualization device 102. At least two cameras are arranged on the blood vessel visualization device 102, wherein one camera is an infrared camera lens used for collecting the intensity of reflected infrared light. At least one camera provided on the blood vessel visualization device 102 is used to monitor the needle puncture removal operation. Preferably, the central processing module 103 can perform the needle puncture removal determination based on the image information collected by the camera. Preferably, the central processing module 103 performs the needle stick/unplug determination by at least one or more of the following steps:
s1: receiving a video collected by a camera at a first moment, determining a frame before blood collection, and determining a blood collection area frame at least comprising a blood collection part of an object to be collected in the frame before blood collection based on the relative position relationship between at least one supporting plane 104 on a blood collection supporting pad 101 and a blood vessel visualization device 102;
s2: continuing to extract the frame number of the video and carrying out target identification detection on the extracted frame number, and determining at least one needle head area frame at least comprising a needle head part by using a target detection method based on a YOLOv3 algorithm under a keras environment at a second moment;
s3: judging whether the blood sampling region frame R1 is overlapped with the needle region frame R2 or not, and detecting the area size of the needle region frame when the overlapping rate obtained by the intersection ratio of the blood sampling region frame R1 and the needle region frame R2 and the union of the blood sampling region frame R3578 and the needle region frame R1 is R1/(R1+ R2);
s4: determining a needle area frame with the current area not larger than 1/2 original area by a target detection method based on a YOLOv3 algorithm under a keras environment at the third moment, and obtaining blood taking needle puncturing operation information and instruction information for indicating the action of the tourniquet 106;
s5: and determining a needle area frame with the current area not smaller than the original area by a target detection method based on the YOLOv3 algorithm in a keras environment at the fourth moment, and obtaining the blood taking needle removing operation information and instruction information for indicating the action of the air bag assembly 105.
According to a preferred embodiment, the central processing module 103 interacts information with hospital medical systems. Preferably, the hospital medical system at least comprises a sequential list of blood sampling objects of the blood sampling department and medical information corresponding to the next object to be sampled. The medical information at least comprises information such as height, weight, age and medical history of the object to be sampled. The central processing module 103 assists in completing the blood collection operation based on its blood collection image analysis of the blood collection visualization device 102 by controlling the way the blood collection support pad 101 and the blood collection visualization device 102 are used in cooperation with each other in the case of determining the medical information of the next blood collection subject. The process of using the blood collection support pad 101 and the blood vessel visualization device 102 in cooperation at least comprises the steps that the central processing module 103 regulates the relative spatial position between at least one support plane 104 of the blood collection support pad 101 based on the medical information to determine that the blood vessel visualization device 102 can acquire at least first image information about the site to be collected of the subject to be collected and second image information acquired when a medical staff performs a trigger event when the arm of the subject to be collected is placed on the support plane 104 in a manner that the site to be collected is exposed. At least one supporting plane 104 is arranged on the blood sampling supporting pad 101. The support plane 104 is used for placing the elbow part of the object to be sampled or the wrist part of the object to be sampled. The relative spatial position between the at least one support plane 104 is the relative position formed by the support plane 104 for supporting the elbow region of the subject to be lanced and the support plane 104 for supporting the wrist region of the subject to be lanced relative to each other in the vertical direction or in the transverse direction or in the respective defined plane. The central processing module 103 regulates the relative spatial position between at least one support plane 104 of the blood collection support pad 101 based on the medical information. According to the section of Chinese adult human body size GB10000-88 and working space human body size GB/T13547-92, the arm length difference of people with different height sections, different sexes and different age sections is obvious. However, in the prior art, the blood sampling mode of the blood sampling supporting pad 101 or the blood sampling mode of the blood sampling supporting pad 101 with a fixed shape is not favorable for individualized demands, and the blood sampling work efficiency of medical workers is seriously influenced by individualized differences while the blood sampling experience provided for blood sampling objects is poor. The auxiliary operating device provided by the invention adopts the split type blood sampling supporting pad 101 with higher flexibility, the blood sampling supporting pad 101 can be adjusted to a corresponding supporting state which is suitable for the medical information to a greater extent by utilizing the existing medical information of the hospital medical system before the next blood sampling object takes blood, and the supporting plane 104 with a certain surface area can provide the position for the object to be sampled to further accurately place the arm, so that the blood sampling working efficiency of medical staff is improved while different individualized requirements of different objects to be sampled are met to the greatest extent.
Preferably, the central processing module 103 is capable of assisting in completing at least one blood collection phase in the process from before blood collection to the end of hemostasis pressing based on a time correlation characteristic between at least hemodynamic information about a site to be collected and at least one blood collection phase acquired through its blood collection image analysis of the first image information and the second image information acquired by the blood vessel visualization device 102. Preferably, the first image information refers to width dimension information of at least one blood vessel located in the mapping region of the blood vessel acquired by the blood vessel visualization device 102 and transmitted to the central processing module 103 for blood sampling image analysis processing. The central processing module 103 analyzes the first image information to obtain width dimension information and cross-sectional information. The mapping region refers to a monitoring region of the blood vessel visualization device 102 with respect to a site to be sampled of a subject to be sampled. Preferably, the second image information acquired by the blood vessel visualization device 102 is acquired at a first time or a first duration when a preset trigger condition of the central processing module 103 is met. The central processing module 103 prestores triggering conditions, and the triggering conditions at least include that the blood vessel is in an on state, an off state and an on state in sequence within a preset time. The executor of the trigger event corresponding to the trigger condition is a medical care personnel who performs blood sampling operation on a blood sampling object, the trigger condition is started based on a manual operation that the medical care personnel presses one end of the blood vessel in the mapping area of the blood vessel visualization device 102 and then quickly releases the blood vessel, and the blood vessel is firstly converted from an originally unblocked state into a state of two-end flow interruption and then restores the unblocked state under the manual operation. The second image information comprises at least the relative distance between the two ends of the interruption and the time to resume clear between the two ends of the interruption. The central processing module 103 can process the obtained blood flow mean linear velocity in the blood vessel section based on the second image information. The mean linear velocity V of venous blood flow is proportional to the flow Q, which is V × S, and inversely proportional to the total area of the vessel cross section S. The blood collection image analysis at least comprises a central processing module 103 receiving and analyzing the first image information and the second image information to obtain hemodynamics information at least comprising blood flow quantitative evaluation results of blood collection subjects.
Preferably, the central processing module 103 assists in completing at least one blood drawing phase in the process from before blood drawing to the end of the hemostasis compression based on the time correlation characteristics between the hemodynamic information and the at least one blood drawing phase. Further preferably, the central processing module 103 divides the blood sampling operation into at least one blood sampling stage having a time sequence in advance. The blood sampling stage at least comprises a blood sampling preparation stage of placing an arm of a subject to be sampled on the blood sampling support pad 101 and selecting a vein vessel suitable for blood sampling with the assistance of the blood vessel visualization device 102, a blood sampling implementation stage of puncturing to the end of puncturing with the assistance of the blood vessel visualization device 102, and a blood sampling hemostasis stage of self-pressing the arm to stop bleeding to the end of hemostasis of the subject to be sampled. Preferably, the time-dependent characteristic refers to obtaining predicted collected blood volumes associated with different blood collection phases based on blood collection image analysis including at least hemodynamic analysis in the different blood collection phases at different times of the blood collection process.
According to a preferred embodiment, the blood collection support pad 101 is provided with a tourniquet 106 for compressing the vein prior to collection of blood to visualize the volume of blood filling the vein. The effective sensing information acquired when the sensing component is relatively fixed with the support plane 104 when the pulse pressing belt 106 acquires the trigger event through the pulse pressing belt 106 which acquires the effective sensing information when the sensing component is in a closed ring shape is sent to the central processing module 103 which acquires the pressing information under the condition that at least one pressure sensor on the pulse pressing belt 106 is in contact with the skin of the object to be sampled, so that the central processing module 103 which acquires the information of the object to be sampled through information with a hospital medical system can indicate at least one expandable component which is arranged on the inner wall of the pulse pressing belt 106 in the closed ring shape and is provided with at least one pressure sensor to expand under the condition that the effective sensing information is acquired, and indicate the expandable component to keep the current expansion posture when the pressing information reaches a preset pressing threshold value. The central processing module 103 which analyzes the blood sampling image of the image information collected by the blood vessel visualization device 102 to monitor the insertion and extraction operation of the blood sampling needle transmits the instruction information generated when the blood sampling image analysis is performed to obtain the puncture operation of the blood sampling needle to the tourniquet 106 which enables the pressure information of the pressure sensor contacting with the skin of the object to be blood sampled to meet the preset pressure threshold value through at least one expandable component, so that the expandable component which is positioned on the tourniquet 106 and keeps the current expansion posture carries out the pressure relief operation according to the instruction information generated when the central processing module 103 obtains the puncture operation of the blood sampling needle, and the initial posture of the pressure information collected by the pressure sensor and not reaching the preset pressure threshold value is recovered.
According to a preferred embodiment, the auxiliary operating device further comprises an air bag module 105 for holding the blood collection subject in a non-empty-punch manner. The air bag assembly 105 is arranged on at least one supporting plane 104 of the blood collecting supporting pad 101 and can introduce air from the outside of the air bag assembly 105 to expand in response to the instruction information sent by the central processing module 103 to the air bag assembly for timely prompting the time for the blood collecting object to release the fist. The central processing module 103, which analyzes the blood sampling image of the image information collected by the blood vessel visualizing device 102 to monitor the operation of inserting and removing the blood sampling needle, transmits the instruction information generated when the central processing module 103 analyzes the blood sampling image to obtain the operation of removing the blood sampling needle to the air bag module 105, which controls the expansion and contraction state by the external gas pressurizing device, so that the air bag module 105 held in the blood sampling object hand in the expansion state when the blood sampling operation is performed prompts and/or forces the hand of the blood sampling object, which is held outside the air bag module 105 in the fist-holding posture when the blood sampling operation is performed, to be converted into the unfolding posture, in which the air bag module 105 is not held, in the gradual expansion mode by the external gas pressurizing device according to the instruction information generated when the central processing module 103 obtains the operation of removing the blood sampling needle. Therefore, the pressing effect of the tourniquet 106 on the hand of the object to be sampled can be cancelled immediately after the medical staff withdraws from the blood sampling needle without the manual operation of the medical staff.
According to a preferred embodiment, the central processing module 103 is further configured to: when medical information of the next blood sampling object is obtained through a hospital medical system, instruction information about palm size parameters corresponding to the medical information is transmitted to the air bag assembly 105 in an expansion state to force the hand of the previous blood sampling object to be in a unfolding posture, so that the air bag assembly 105 is subjected to pressure relief operation through an external gas pressurization device under the condition that the air bag assembly is separated from a holding relation with the hand of the previous blood sampling object in the unfolding posture, and is converted into an expansion state matched with the medical information of the next blood sampling object. Therefore, the pressure relief operation of the air bag assembly 105 provides an expansion state suitable for the next blood-taking subject to hold while facilitating the hand of the previous blood-taking subject to be separated from the blood-taking supporting pad 101.
According to a preferred embodiment, the blood collection support pad 101 comprises at least one support plane 104 with a spatial position relative to each other facilitating the exposure of the site to be collected. The medical information of the next blood sampling object is obtained by the medical system of the hospital at the central processing module 103, the instruction information about the arm spread size parameter corresponding to the medical information is transmitted to the blood sampling supporting pad 101 which forms a first relative space position matched with the arm size parameter of the previous blood sampling object through at least one supporting plane 104, so that the blood collection supporting pad 101 is converted into a second relative spatial position adapted to medical information of the next blood collection subject by means of the at least one supporting plane 104 being movably regulated in a lateral direction defined by the arrangement direction of the at least one supporting plane 104 or in a longitudinal direction perpendicular thereto with respect to the imaginary plane for supporting the blood collection supporting pad 101, therefore, the blood sampling supporting pad 101 only needs to adjust the supporting plane 104 with a small amplitude or does not need to adjust to provide a relative space position suitable for the next blood sampling object to place the arm.
According to a preferred embodiment, the central processing module 103 is configured to obtain the first image information acquired by the blood vessel visualization device 102 at least about the blood to be sampled of the blood subject and/or the second image information acquired when the medical staff performs the trigger event, so as to obtain the hemodynamic information providing the medical staff with the prompt information about the sufficiency of the collected blood volume by the blood vessel visualization device 102 transmitting the real-time image information to the hand of the blood subject by analyzing the blood sampling image of the first image information and/or the second image information.
An auxiliary operation method of an auxiliary operation device by means of a non-contact blood vessel visualization device 102, the auxiliary operation method at least comprises a blood sampling support pad 101, a blood vessel visualization device 102 and a central processing module 103, the blood sampling support pad 101 is used for providing support and fixation for an arm of a blood sampling object, the blood vessel visualization device 102 is assembled above the blood sampling support pad 101 and is used for matching with the blood sampling support pad 101 to provide hemodynamics monitoring for projecting a subsurface structure onto the surface of the object, and the auxiliary operation method at least comprises the following steps: the central processing module 103 performs information interaction with a hospital medical system to assist medical staff in completing blood sampling operation at least based on blood sampling image analysis of image information acquired by the blood vessel visualization device 102 providing blood flow dynamics monitoring by controlling the blood sampling support pad 101 and the blood vessel visualization device 102 to be used in cooperation with each other under the condition of determining medical information of a next blood sampling object.
Specifically, in the blood sampling preparation stage, based on blood sampling support pad 101 that has roughly adjusted automatically, treat that blood sampling object's arm exposes its portion of waiting to blood sampling completely with anticipated angle, medical personnel orders to treat that blood sampling object lightly holds gasbag subassembly 105 that is under certain inflation state, treats that blood sampling object no longer is traditional be unfavorable for waiting to blood sampling object perception to hold the air fist posture of dynamics but effectively keeps the comparatively invariable dynamics of holding in the blood sampling in-process under gasbag subassembly 105 when taking a blood sample. Meanwhile, the medical staff surrounds the hand of the object to be blood-sampled with the belt body provided with the sensing assembly on the pulse-pressing belt 106 and fixes the pulse-pressing belt on the blood-sampling supporting pad 101, and based on the effective sensing information of the sensing assembly, the pulse-pressing belt 106 presses the arm of the object to be blood-sampled under an external gas pressurizing device until reaching a preset pressure threshold. The pressing operation is performed by the central processing module 103 after processing the information of the blood-taking object and determining whether the blood-taking object has the historical medical information about the weak blood vessel wall or is the old with the over-aged elastic deviation of the blood vessel wall. Therefore, when the blood sampling object has the weak historical medical information about the blood vessel wall or the old people with the over-aged blood vessel wall elasticity deviation are detected, the pressure threshold value can be correspondingly reduced to avoid the problem of blood vessel wall rupture. At this time, the blood vessel visualization device 102 projects the video information acquired by the infrared camera lens to the blood sampling part, and the medical staff selects the blood vessel suitable for puncture by simply pressing and releasing the two ends of the blood vessel. Preferably, the vessel visualization device 102 supports the medical personnel to narrow the projected area to a smaller area of the vessel to be punctured. After the part to be sampled is disinfected, the medical staff pierces the needle of the blood sampling needle into the part to be sampled, and then the central processing module 103 can instruct the pulse pressing belt 106 to remove the pressure applied to the arm of the object to be sampled based on the processed blood sampling puncturing operation information. Preferably, if the central processing module 103 detects that the tying time of the tourniquet 106 exceeds 1min, the medical staff is prompted or the tourniquet 106 is instructed to perform the pressure relief operation. When the time of the pulse pressing belt 106 for binding the belt exceeds 1min, the large venous blood flow is blocked, so that the internal pressure of the capillary vessel is increased, the blood in the vessel is communicated with the interstitial fluid, and substances with the relative molecular weight less than 5000 can escape into the interstitial fluid, and meanwhile, as the time of the compression is prolonged, the local tissues generate oxygen deficiency to cause large change of blood components, and the detection result is increased or reduced inadvisable. In the blood collection process, the central processing module 103 and the hospital medical system perform information interaction to obtain blood collection information including at least blood collection volume of the next subject to be collected, and when the blood collection puncturing operation information is judged to be obtained, the central processing module 103 estimates the blood collection time based on the blood flow volume information and the blood collection information obtained by processing, so that medical staff is prompted when the estimated blood collection time is reached. The medical staff then presses the needle hole with a sterile cotton ball and pulls the needle out of the vein. At this time, the central processing module 103 can prompt the blood collecting object to release the fist based on the processed blood collecting and removing operation information, and then instruct the air bag module 105 to perform the pressurizing operation. Therefore, the situation that blood stasis is caused by blood flowing out of the blood vessel due to the fact that the blood vessel wall is not easy to repair caused by clenching a fist with force is reduced. The auxiliary operating device provided by the invention is suitable for common blood routine blood sampling operation. The auxiliary operating device provided by the invention is also suitable for blood donation and blood collection operation needing to collect at least 200ml, and particularly can effectively and reliably prompt the treatment sequence of medical staff when the attention of a single medical staff is inevitably dispersed when the blood is collected for two blood donors at the same time. The auxiliary operation device provided by the invention is also suitable for hemodialysis operation with a large blood exchange amount, and can effectively and reliably prompt medical staff for the occurrence of cardiovascular function complications caused by an overlarge difference between a blood sampling speed and a backflow speed.
It should be noted that the above-mentioned embodiments are exemplary, and that those skilled in the art, having benefit of the present disclosure, may devise various arrangements that are within the scope of the present disclosure and that fall within the scope of the invention. It should be understood by those skilled in the art that the present specification and figures are illustrative only and are not limiting upon the claims. The scope of the invention is defined by the claims and their equivalents.

Claims (10)

1. Blood collection aid for separating a serum sample from whole blood, comprising at least:
the blood collection tube body (1) is used for storing collected liquid;
a blood collection tube cap (2) that is fitted to the blood collection tube body (1); and
a blood collection sub-packaging assembly (3) which can controllably convey the liquid in the blood collection tube body (1) to the outside of the blood collection tube body (1) in a mode that one end of the blood collection sub-packaging assembly is in fit connection with the blood collection tube cover (2),
it is characterized in that the utility model is characterized in that,
the blood collection separate assembly (3) is configured to output the liquid stored in the blood collection tube body (1) in a specified amount in a divided manner in such a manner that the gas coming from the outside of the blood collection tube body (1) through the blood collection tube cap (2) does not pass through the liquid stored in the blood collection tube body (1).
2. Blood collection aid according to claim 1, wherein a hollow plate (6) is provided inside the blood collection tube body (1), the hollow plate (6) being configured to:
allowing the gas channel (4) to be communicated with the inner cavity of the blood sampling sub-packaging assembly (3) when the blood sampling sub-packaging assembly is in fit connection with the blood sampling tube cover (2).
3. Blood collection aid according to one of the preceding claims,
the hollow plate (6) is assembled to the blood collection tube body (1) before the blood collection operation is performed by the blood collection tube body (1),
the both ends of at least one first through-hole (9) that set up on its plate body of cavity board (6) respectively with the inside of heparin tube body (1) is linked together and with the inner chamber of cavity board (6) is isolated.
4. Blood collection aid according to one of the preceding claims,
the blood sampling auxiliary device at least comprises a pressurizing gap (7), and the pressurizing gap (7) is an area which is formed when the blood sampling sub-packaging assembly (3) is in fit connection with the blood sampling tube cover (2) and is used for providing a specified amount of gas for the gas channel (4).
5. Blood collection aid according to one of the preceding claims,
the lancing aid comprises at least a liquid level monitoring assembly (8), wherein the lancing aid is configured to:
based on the specified amount of gas input along the gas channel (4) and the liquid flow between different liquid level positions monitored by the liquid level monitoring assembly (8) at different times.
6. Blood collection aid according to one of the preceding claims,
the blood collection aid is configured to:
acquiring a third liquid level position and a fourth liquid level position acquired by the blood sampling auxiliary device when the blood sampling tube body (1) is in the second placing state, and determining the total amount of the liquid acquired by using the blood sampling tube body (1) so that a user can determine at least one distribution mode of the liquid based on the total amount of the liquid.
7. Blood collection aid according to one of the preceding claims,
part of the plate surface on the hollow plate (6) extends towards the direction far away from the blood collection tube cover (2), so that the inner cavity of the hollow plate (6) is provided with an open end which extends along the central axis direction of the blood collection tube body (1) and is positioned on a different imaginary horizontal plane from the plate surface of the hollow plate (6).
8. Blood collection aid system for separating a serum sample from whole blood, comprising at least:
the blood collection tube body (1) is used for storing collected liquid;
a blood collection tube cap (2) that is fitted to the blood collection tube body (1); and
a blood collection sub-packaging assembly (3) which can controllably convey the liquid in the blood collection tube body (1) to the outside of the blood collection tube body (1) in a mode that one end of the blood collection sub-packaging assembly is in fit connection with the blood collection tube cover (2),
it is characterized in that the utility model is characterized in that,
the blood collection auxiliary system is configured to cause the liquid stored in the blood collection tube body (1) to be output in specified amount in a divided manner in such a manner that the gas from the outside of the blood collection tube body (1) via the blood collection tube cap (2) does not pass through the liquid stored in the blood collection tube body (1) when the blood collection sub-packaging assembly (3) and the blood collection tube cap (2) are fittingly connected to form an area for supplying a specified amount of gas to the gas channel (4).
9. The blood collection assist system of claim 8,
the blood collection auxiliary system at least comprises a hollow plate (6) arranged in the blood collection tube body (1), wherein the hollow plate (6) is configured to:
allowing the gas channel (4) to be communicated with the inner cavity of the blood sampling sub-packaging assembly (3) when the blood sampling sub-packaging assembly is in fit connection with the blood sampling tube cover (2).
10. The blood collection assist system of claim 8,
the blood collection assistance system comprises at least a liquid level monitoring assembly (8), wherein the blood collection assistance system is configured to be based on a specified amount of gas input along the gas channel (4) and a liquid flow rate between different liquid level positions monitored by the liquid level monitoring assembly (8) at different times.
CN202010076162.9A 2020-01-22 2020-01-22 Blood collection aid and method for separating a serum sample from whole blood Active CN111265224B (en)

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CN112256362A (en) * 2020-09-11 2021-01-22 四川九八村信息科技有限公司 Intelligent blood sampling method and system with visual guide prompt and intelligent blood sampler
CN112625886A (en) * 2020-12-31 2021-04-09 无锡市第五人民医院 A automatic partial shipment device of nasopharynx swab for new coronary pneumonia virus detects
WO2022028219A1 (en) * 2020-08-01 2022-02-10 河南方舟医疗器械有限公司 Sterile preparation, packaging, and output system for blood serum, and method

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US5055203A (en) * 1990-05-22 1991-10-08 Eastman Kodak Company Blood collection device with reduced serum dispensing volume and integral needle
JPH0727770A (en) * 1993-07-14 1995-01-31 Aloka Co Ltd Monitoring method of discharge amount and liquid drip amount and its dispensing apparatus
CN102300595A (en) * 2009-02-04 2011-12-28 株式会社Jms Liquid component collecting device

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Publication number Priority date Publication date Assignee Title
US5055203A (en) * 1990-05-22 1991-10-08 Eastman Kodak Company Blood collection device with reduced serum dispensing volume and integral needle
JPH0727770A (en) * 1993-07-14 1995-01-31 Aloka Co Ltd Monitoring method of discharge amount and liquid drip amount and its dispensing apparatus
CN102300595A (en) * 2009-02-04 2011-12-28 株式会社Jms Liquid component collecting device

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022028219A1 (en) * 2020-08-01 2022-02-10 河南方舟医疗器械有限公司 Sterile preparation, packaging, and output system for blood serum, and method
CN112256362A (en) * 2020-09-11 2021-01-22 四川九八村信息科技有限公司 Intelligent blood sampling method and system with visual guide prompt and intelligent blood sampler
CN112256362B (en) * 2020-09-11 2023-07-25 四川南格尔生物科技有限公司 Intelligent blood sampling method and system with visual guiding prompt and intelligent blood sampling instrument
CN112625886A (en) * 2020-12-31 2021-04-09 无锡市第五人民医院 A automatic partial shipment device of nasopharynx swab for new coronary pneumonia virus detects
CN112625886B (en) * 2020-12-31 2024-04-05 无锡市第五人民医院 Automatic nasopharynx swab split charging device for detecting novel coronavirus

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