WO2021000743A1 - 试剂支架、检测设备总成、房水采集装置和房水采集方法 - Google Patents

试剂支架、检测设备总成、房水采集装置和房水采集方法 Download PDF

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Publication number
WO2021000743A1
WO2021000743A1 PCT/CN2020/096860 CN2020096860W WO2021000743A1 WO 2021000743 A1 WO2021000743 A1 WO 2021000743A1 CN 2020096860 W CN2020096860 W CN 2020096860W WO 2021000743 A1 WO2021000743 A1 WO 2021000743A1
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WO
WIPO (PCT)
Prior art keywords
liquid
tube
aqueous humor
puncture needle
outer cylinder
Prior art date
Application number
PCT/CN2020/096860
Other languages
English (en)
French (fr)
Inventor
夏超然
孙月广
Original Assignee
北京华视诺维医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN201910591368.2A external-priority patent/CN110236783B/zh
Priority claimed from PCT/CN2019/094384 external-priority patent/WO2021000256A1/zh
Priority claimed from PCT/CN2019/094383 external-priority patent/WO2021000255A1/zh
Priority claimed from CN201921024325.8U external-priority patent/CN210872424U/zh
Priority claimed from CN201910591476.XA external-priority patent/CN110236784B/zh
Priority claimed from CN201921028861.5U external-priority patent/CN210872426U/zh
Priority claimed from CN201921024358.2U external-priority patent/CN210872425U/zh
Priority claimed from CN201910590699.4A external-priority patent/CN110236782B/zh
Priority claimed from PCT/CN2019/110062 external-priority patent/WO2021000440A1/zh
Priority claimed from CN202020647300.XU external-priority patent/CN213000114U/zh
Priority claimed from CN202020644381.8U external-priority patent/CN212008627U/zh
Priority to JP2021577950A priority Critical patent/JP7337967B2/ja
Application filed by 北京华视诺维医疗科技有限公司 filed Critical 北京华视诺维医疗科技有限公司
Priority to US17/624,393 priority patent/US20220354468A1/en
Priority to EP20834808.6A priority patent/EP3995215A4/en
Publication of WO2021000743A1 publication Critical patent/WO2021000743A1/zh
Priority to IL289549A priority patent/IL289549A/en
Priority to JP2023134836A priority patent/JP2023164441A/ja

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045Devices for taking samples of body liquids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0096Casings for storing test samples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery
    • A61F9/00736Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/02Burettes; Pipettes
    • B01L3/021Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids
    • B01L3/0217Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids of the plunger pump type
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5085Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above for multiple samples, e.g. microtitration plates
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L9/00Supporting devices; Holding devices
    • B01L9/06Test-tube stands; Test-tube holders
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/02Adapting objects or devices to another
    • B01L2200/026Fluid interfacing between devices or objects, e.g. connectors, inlet details
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/16Reagents, handling or storing thereof
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/04Closures and closing means
    • B01L2300/041Connecting closures to device or container
    • B01L2300/042Caps; Plugs
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/06Auxiliary integrated devices, integrated components
    • B01L2300/0609Holders integrated in container to position an object
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/06Auxiliary integrated devices, integrated components
    • B01L2300/0672Integrated piercing tool
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/12Specific details about materials
    • B01L2300/123Flexible; Elastomeric
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00Moving or stopping fluids
    • B01L2400/04Moving fluids with specific forces or mechanical means
    • B01L2400/0475Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure
    • B01L2400/0478Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure pistons

Definitions

  • the present invention relates to the technical field of medical appliances, specifically, for example, to an aqueous humor collection device and method, a reagent holder and detection equipment assembly, and a combined aqueous humor collection and detection device and method.
  • some testing equipment is equipped with a sampling needle to extend into the cavity of the sample container for sampling.
  • the testing equipment usually has a striker protection function, namely When the needle rigidly hits the inner wall of the sample container, an error is reported and the machine stops. Therefore, in order to ensure the continuity of the sampling process, it is necessary to limit the penetration depth of the needle to prevent it from touching the bottom wall of the sample container.
  • the sample container can hold a small amount of sample, if the penetration depth of the needle is shallow, the actual amount of sample that can be extracted will be too small.
  • the present invention provides a reagent holder, a detection equipment assembly, an aqueous humor collection device and an aqueous humor collection method, which can convert the rigid collision between the liquid taking device and the liquid receiving tube into The elastic collision avoids triggering the striker protection function during the liquid extraction process to effectively increase the sample extraction volume.
  • the present invention provides a reagent holder, the reagent holder includes a holder body and a functional position provided on the holder body, the functional position includes a liquid-containing tube insertion hole And an elastic member, the elastic member is configured to be capable of elastically acting on the liquid receiving tube when the liquid receiving tube is inserted into the liquid receiving hole, so that the liquid receiving tube can be moved along The central axis of the insertion hole of the liquid-containing tube elastically moves.
  • the functional position further includes a functional position outer sleeve, which protrudes downward from the inner peripheral wall of the liquid-containing tube insertion hole in the direction of the center axis of the hole, and the elastic The component is located in the inner cavity of the outer sleeve of the functional position.
  • the elastic component is a spring mechanism or an elastic medium.
  • the spring mechanism is located at the bottom of the inner cavity of the sleeve and can be elastically moved along the central axis of the hole.
  • the outer periphery of the spring mechanism is at least partially attached to The inner peripheral wall of the inner cavity of the sleeve slips.
  • the reagent holder further includes a conversion socket that is detachably inserted into the insertion hole of the liquid containing tube, and the conversion socket includes a support sleeve portion and an extension sleeve portion connected up and down, the support
  • the sleeve cavity of the sleeve part communicates with the sleeve cavity of the extension sleeve part up and down and is jointly formed as a conversion and insertion cavity, and the conversion and insertion cavity is used for detachably inserting the liquid receiving tube.
  • the functional position is a sample position, a reagent position, a photometric position, a reaction position or a reserved position.
  • the present invention provides a detection device assembly
  • the detection device assembly includes a detection device, a liquid containing tube and the above reagent holder, the liquid containing tube is detachably inserted in the In the insertion hole of the liquid containing tube, the detection device includes a liquid taking device configured to extend into the lumen of the liquid containing tube to take liquid.
  • the detection device is configured to stop when the liquid taking device is subjected to a rigid collision.
  • the functional position further includes a functional position outer sleeve which protrudes downward from the inner peripheral wall of the liquid receiving tube insertion hole in the direction of the center axis of the hole, and the container
  • the outer contour of the bottom of the liquid tube is inverted cone shape, the liquid tube passes through the liquid tube insertion hole to be inserted into the sleeve cavity of the outer sleeve of the functional position, and the top end of the liquid tube is not Higher than the orifice of the insertion hole of the liquid containing tube, the outer diameter of the nozzle of the liquid containing tube is the same as the inner diameter of the inner cavity of the sleeve.
  • the liquid taking device is provided with a liquid taking needle used to extend into the lumen of the liquid receiving tube to take liquid, the outer end surface of the liquid taking needle is formed as an inclined end surface and the inclined end surface is formed with Liquid intake.
  • the liquid receiving tube when the liquid taking device extends into the lumen of the liquid receiving tube to take liquid and touches its bottom wall, the liquid receiving tube can be inserted along the liquid receiving tube due to the elastic action of the elastic component in the reagent holder.
  • the hole center axis direction of the hole is elastically moved, so that the rigid collision between the liquid taking device and the bottom wall of the liquid tube is converted into an elastic collision.
  • the detection device will not trigger the striker protection function.
  • the reagent holder of the present invention when the reagent holder of the present invention is used to elastically fix the liquid receiving tube, the depth of the liquid taking device protruding into the lumen of the liquid receiving tube can be greatly increased, thereby effectively increasing the sample extraction volume.
  • the present invention provides a detection device assembly, which includes:
  • the reagent holder is provided with a holder body and a functional position arranged on the holder body, the functional position including a liquid-containing tube insertion hole and an elastic component;
  • the liquid receiving tube is detachably inserted into the liquid receiving tube insertion hole, and the liquid receiving tube can be elastically acted by the elastic member to be elastic along the central axis direction of the liquid receiving tube insertion hole mobile;
  • the detecting device is provided with a liquid taking needle for drawing liquid in the lumen of the liquid receiving tube, the outer end surface of the liquid taking needle is formed as an inclined end surface and a liquid taking port is formed on the inclined end surface.
  • the liquid taking needle extends along a straight line and includes a needle body section and a needle head section that are connected to each other, the outer end of the needle head section is formed with the liquid taking port, and the central axis of the needle body section of the needle body section is connected to the The central axis of the liquid taking port intersects.
  • the acute angle formed by the intersection of the central axis of the needle body section and the central axis of the liquid intake is ⁇ , and ⁇ satisfies: 0 ⁇ 0.1°.
  • the inclined end surface is a curved surface or a flat surface.
  • the inner bottom wall of the lumen of the liquid containing tube is a flat wall or a curved wall.
  • the detection device is configured to stop when the liquid withdrawal needle is subjected to a rigid collision.
  • the functional position further includes a functional position outer sleeve, which protrudes downward from the inner peripheral wall of the liquid-containing tube insertion hole in the direction of the center axis of the hole, and the elastic The component is located in the inner cavity of the outer sleeve of the functional position.
  • the elastic component is a spring mechanism or an elastic medium.
  • the elastic component is located at the bottom of the inner cavity of the sleeve, a support recess for supporting the bottom of the liquid receiving tube is formed in the center of the top of the elastic component, and the bottom outer contour of the liquid receiving tube It is in an inverted cone shape, and the shape of the support recess matches the outer contour of the bottom of the liquid receiving tube.
  • the functional position is a sample position, a reagent position, a photometric position, a reaction position or a reserved position.
  • the liquid receiving tube is elastically fixed in the reagent holder, when the liquid taking needle extends into the lumen of the liquid receiving tube to take liquid and touches the bottom wall thereof, the liquid taking needle There is only an elastic collision with the bottom wall of the liquid containing tube, so the striker protection function will not be triggered. Since the outer end surface of the liquid taking needle is formed as an inclined end surface and the liquid taking port is arranged on the inclined end surface, even if the liquid taking needle touches the bottom wall of the liquid receiving tube of different shapes, the liquid taking port will not be sealed and affected Normal liquid extraction is beneficial to increase the sample extraction volume during liquid extraction and can ensure smooth liquid extraction during liquid extraction.
  • the reagent holder and detection equipment assembly of the present invention can be used in conjunction with the aqueous humor collection device and method.
  • Anterior chamber puncture of the eye is a medical technology that pierces the cornea of the eye to make the aqueous humor flow out. It has important application value in ophthalmology clinical research work. It is mainly used to reduce intraocular pressure, aqueous humor collection and other therapeutic pretreatments. Room discharge.
  • the present invention provides an aqueous humor collection device that can control the drainage speed of aqueous humor during the puncture process, and can avoid contamination of the aqueous humor after collection and waste due to transfer , Thereby improving safety and reliability.
  • the present invention provides an aqueous humor collection device, the aqueous humor collection device comprising:
  • the outer cylinder is provided with a puncture needle installation end and a liquid sampling tube installation end at both axial ends;
  • the puncture needle is fixedly installed at the puncture needle installation end and is provided with an inner end of the puncture needle located in the barrel cavity of the outer cylinder and an outer end of the puncture needle located outside the barrel cavity of the outer cylinder;
  • the liquid sampling tube assembly includes a liquid sampling tube that is inserted into the outer cylinder cavity from the installation end of the liquid sampling tube and can be inserted and removed in an axial direction, and is arranged in the outer cylinder cavity for The pipe plug for sealing the nozzle of the liquid sampling pipe;
  • the static friction coefficient between the pipe plug and the inner peripheral wall of the outer cylinder is ⁇ 1
  • the static friction coefficient between the pipe plug and the nozzle of the liquid collection tube is ⁇ 2, and satisfies: ⁇ 1 ⁇ 2;
  • the pipe plug is arranged at intervals on the inner peripheral wall of the outer cylinder.
  • the annular limiting member is an elastic member.
  • smooth contact is formed between the pipe plug and the inner peripheral wall of the outer cylinder.
  • the aqueous humor collection device further includes an anti-sloshing structure for limiting the displacement of the liquid sampling tube assembly along the radial direction of the outer cylinder cavity.
  • the anti-sloshing structure includes an annular groove formed on the outer peripheral wall of the liquid sampling tube assembly and an annular stopper arranged around the annular groove. The radial direction of the annular stopper The outer end abuts against the inner peripheral wall of the outer cylinder.
  • the annular limiting member is a rubber band.
  • the groove side wall of the annular groove is formed with a groove vent hole penetrating along the axial direction of the outer cylinder cavity, and the outer cylinder cavity is between the pipe plug and the piercing hole.
  • the barrel cavity area between the needle mounting ends communicates with the groove vent.
  • the liquid sampling tube assembly includes a supporting tube frame, the liquid sampling tube is inserted into the inner cavity of the supporting tube frame, and the annular groove is provided on the outer peripheral wall of the supporting tube frame. on.
  • the liquid sampling tube assembly further includes a supporting tube rack, the liquid sampling tube is inserted into the inner cavity of the tube rack of the supporting tube rack, and the anti-sloshing structure includes an outer circumference of the supporting tube rack.
  • a wall or a limiting protrusion protruding from the inner peripheral wall of the outer cylinder, and the radial ends of the limiting protrusion are respectively connected to the outer peripheral wall of the support tube frame and the inner peripheral wall of the outer cylinder.
  • the aqueous humor collection device further includes a needle holder for fixing the puncture needle, and a quick plug connection is formed between the inner end of the needle holder and the puncture needle installation end.
  • a threaded connection or a snap connection is formed between the inner end of the needle holder and the puncture needle mounting end.
  • the aqueous humor collection device further includes an anti-puncture spacer for isolating the inner end of the puncture needle from the tube plug along the axial direction of the outer cylinder cavity, the anti-puncture spacer It is a detachable piece.
  • the peripheral wall of the outer cylinder is provided with a spacer insertion groove, and the outer cylinder cavity is connected to the spacer insertion groove in the region of the cylinder cavity between the inner end of the puncture needle and the pipe plug.
  • a slot, the anti-puncture spacer is inserted into the barrel cavity area through the spacer insertion slot.
  • the liquid sampling tube assembly is provided with a tube plug so that the liquid sampling tube lumen is in a negative pressure state.
  • the inner end of the puncture needle pierces the tube plug to drain the aqueous humor to the liquid sampling tube lumen.
  • the difference between the pressure in the lumen and the pressure in the anterior chamber is gradually reduced, so that the drainage speed of aqueous humor is gradually reduced, thereby avoiding the dangerous situation of sudden drop in intraocular pressure and greatly improving safety.
  • the static friction coefficient ⁇ 1 between the pipe plug and the inner peripheral wall of the outer cylinder is smaller than the static friction coefficient between the pipe plug and the nozzle of the liquid sampling tube, which is ⁇ 2, or the pipe plug is arranged at intervals on the inner peripheral wall of the outer cylinder, Ensure that when the liquid sampling tube assembly is pulled out from the outer barrel cavity, the pipe plug always tightly blocks the liquid sampling tube nozzle, avoiding the contact of the aqueous humor in the lumen with the external environment, and ensuring the quality of the collected aqueous humor. Purity, and can avoid the waste caused by the transfer of aqueous humor, thereby improving the reliability of subsequent detection.
  • the present invention provides an aqueous humor collection device, which includes:
  • the outer cylinder is provided with a puncture needle installation end and a liquid collection tube installation end;
  • the liquid sampling tube assembly is pluggable and movably inserted from the installation end of the liquid sampling tube into the barrel cavity of the outer cylinder and includes a liquid sampling tube and a liquid sampling tube for sealing in the barrel cavity of the outer cylinder
  • the pipe plug of the nozzle is pluggable and movably inserted from the installation end of the liquid sampling tube into the barrel cavity of the outer cylinder and includes a liquid sampling tube and a liquid sampling tube for sealing in the barrel cavity of the outer cylinder.
  • a ventilation structure is formed between the liquid sampling tube assembly and the inner peripheral wall of the outer cylinder, and the ventilation structure communicates with the cylinder cavity area of the outer cylinder cavity between the inner end of the puncture needle and the tube plug,
  • the aqueous humor collection device further includes a limiting buffer structure for limiting the displacement of the sampling tube assembly in the radial direction and for forming contact damping between the sampling tube assembly and the inner peripheral wall of the outer cylinder.
  • the limiting buffer structure includes a limiting protrusion protruding from the outer peripheral wall of the sampling tube assembly or from the inner peripheral wall of the outer cylinder, and the radial ends of the limiting protrusion are respectively connected to the The outer peripheral wall of the liquid sampling tube assembly and the inner peripheral wall of the outer cylinder.
  • the limiting buffer structure includes the limiting protrusions arranged at intervals along the tube length direction of the sampling tube assembly or continuously extending along the tube length direction, and the limiting protrusions are arranged along the length of the tube.
  • the total span of the tube length direction is not less than half of the length of the liquid sampling tube.
  • the limiting protrusion is integrally formed on the outer peripheral wall of the liquid sampling tube; or, the liquid sampling tube assembly includes a tube set sheathed on the outer peripheral wall of the liquid sampling tube, and the limiting protrusion The position protrusion is arranged on the outer peripheral wall of the tube set.
  • the tube set is an elastic tube set.
  • the limiting and buffering structure includes a plurality of limiting protrusions arranged at intervals in a circumferential direction, and gaps between the plurality of limiting protrusions are formed as the ventilation structure;
  • the limiting buffer structure includes the limiting protrusion formed continuously extending in the circumferential direction, between the limiting protrusion and the outer peripheral wall of the liquid sampling tube assembly or between the limiting protrusion and the A vent gap as the ventilation structure is formed between the inner peripheral wall of the outer cylinder.
  • a plurality of the limiting protrusions arranged at intervals along the circumferential direction are all convex points.
  • the limiting protrusion formed continuously extending in the circumferential direction is in a corrugated shape or an oblique tooth shape.
  • the liquid sampling tube assembly further includes a supporting tube frame for fixing the liquid sampling tube, and the limiting buffer structure is formed between the outer peripheral wall of the supporting tube frame and the inner peripheral wall of the outer cylinder .
  • liquid sampling tube and the supporting tube frame are fixed by screw connection or snap connection.
  • the aqueous humor collection device since the aqueous humor collection device is provided with a limit buffer structure, it can limit its displacement along the radial direction during the process of plugging and unplugging the sampling tube assembly, that is, to ensure that the sampling tube assembly only moves in the axial direction, and It can produce a certain degree of movement damping to prevent the insertion and extraction speed from being too fast, so it can not only ensure that the inner end of the puncture needle accurately pierces the tube plug to be inserted into the lumen of the liquid collection tube, but also ensures stable extraction after the aqueous humor is collected. Take out the liquid extraction tube assembly to avoid leakage of aqueous humor in the tube cavity and greatly improve reliability.
  • the liquid sampling tube assembly is provided with a tube plug so that the lumen of the liquid sampling tube is in a negative pressure state.
  • the puncture needle pierces the tube plug to drain the aqueous humor into the liquid sampling tube lumen, it follows The amount of fluid gradually increases, and the difference between the pressure in the lumen and the pressure in the anterior chamber gradually decreases, so the drainage speed of aqueous humor is gradually reduced, thereby avoiding the dangerous situation of sudden drop in intraocular pressure and greatly improving safety.
  • the liquid sampling tube assembly can be pulled out from the outer cylinder cavity as a whole, and the aqueous humor in the liquid sampling tube can be detected directly, no further transfer is required, so it can avoid the The aqueous humor contacts the external environment to ensure the purity of the collected aqueous humor, thereby improving the accuracy of subsequent testing.
  • the present invention provides an aqueous humor collection device, which includes:
  • the outer cylinder including the puncture needle installation end and the liquid collection tube installation end;
  • a puncture needle is fixedly installed at the puncture needle mounting end, the puncture needle includes an inner end of the puncture needle and an outer end of the puncture needle respectively protruding from both axial sides of the puncture needle mounting end;
  • the liquid sampling tube assembly includes a liquid sampling tube inserted into the outer cylinder cavity from the installation end of the liquid sampling tube and capable of being inserted and pulled out in the axial direction, and is arranged in the outer cylinder cavity for sealing the sampling The plug of the nozzle of the liquid pipe;
  • the pipe plug is coaxially arranged with the cavity of the outer cylinder, and the radius of the pipe plug is smaller than the radius of the inner peripheral wall of the outer cylinder, and the outer peripheral wall of the liquid sampling tube assembly is provided with an annular groove and a hoop.
  • the annular stopper provided in the annular groove, the radially outer end of the annular stopper abuts against the inner peripheral wall of the outer cylinder.
  • the radial distance between the radially outer end of the pipe plug and the inner peripheral wall of the outer cylinder is not less than 1 mm.
  • the liquid sampling tube assembly includes a supporting tube frame, the liquid sampling tube is inserted into the inner cavity of the supporting tube frame, and the annular groove is provided on the outer peripheral wall of the supporting tube frame. on.
  • a threaded connection or a snap connection is formed between the liquid sampling tube and the supporting tube frame.
  • the groove side wall of the annular groove is formed with a groove vent hole penetrating along the axial direction of the outer cylinder cavity, and the outer cylinder cavity is between the pipe plug and the piercing hole.
  • the barrel cavity area between the needle mounting ends communicates with the groove vent.
  • the annular limiting member is an elastic member.
  • the aqueous humor collection device further includes a needle holder for fixing the puncture needle, and a quick plug connection is formed between the inner end of the needle holder and the puncture needle installation end.
  • a threaded connection or a snap connection is formed between the inner end of the needle holder and the puncture needle mounting end.
  • the aqueous humor collection device further includes an anti-puncture spacer for isolating the inner end of the puncture needle from the tube plug along the axial direction of the outer cylinder cavity, the anti-puncture spacer It is a detachable piece.
  • the peripheral wall of the outer cylinder is provided with a spacer insertion groove, and the outer cylinder cavity is connected to the spacer insertion groove in the region of the cylinder cavity between the inner end of the puncture needle and the pipe plug.
  • a slot, the anti-puncture spacer is inserted into the barrel cavity area through the spacer insertion slot.
  • the liquid sampling tube assembly is provided with a tube plug so that the liquid sampling tube lumen is in a negative pressure state.
  • the inner end of the puncture needle pierces the tube plug to drain the aqueous humor to the liquid sampling tube lumen.
  • the difference between the pressure in the lumen and the pressure in the anterior chamber is gradually reduced, so that the drainage speed of aqueous humor is gradually reduced, thereby avoiding the dangerous situation of sudden drop in intraocular pressure and greatly improving safety.
  • the tube plug since the radius of the tube plug is defined to be smaller than the radius of the inner peripheral wall of the outer cylinder, the tube plug does not come into contact with the inner peripheral wall of the outer cylinder, which can ensure that the tube plug is pulled out from the outer cylinder cavity.
  • the present invention provides an aqueous humor collection device, which includes:
  • the outer cylinder including the puncture needle installation end and the liquid collection tube installation end;
  • the puncture needle is fixedly installed at the puncture needle installation end and is provided with an inner end of the puncture needle located in the barrel cavity of the outer cylinder and an outer end of the puncture needle located outside the barrel cavity of the outer cylinder;
  • the liquid sampling tube assembly includes a liquid sampling tube inserted into the outer cylinder cavity from the installation end of the liquid sampling tube and capable of being inserted and pulled out in the axial direction, and is arranged in the outer cylinder cavity for sealing the sampling The plug of the nozzle of the liquid pipe;
  • the outer peripheral wall of the liquid sampling tube assembly is provided with an annular groove and an annular stopper arranged around the annular groove, and the radially outer end of the annular stopper abuts against the inner peripheral wall of the outer cylinder, so The radially outer edge of the pipe plug is in smooth contact with the inner peripheral wall of the outer cylinder, and a pipe plug exhaust channel is provided along the extension direction of the outer cylinder cavity.
  • the barrel cavity area between the pipe plug and the mounting end of the puncture needle communicates with the pipe plug exhaust passage.
  • the pipe plug is provided with a plurality of pipe plug exhaust passages that extend along the axial direction of the outer cylinder cavity and are sequentially spaced in the circumferential direction of the pipe plug.
  • a pipe plug exhaust groove serving as the pipe plug exhaust passage is formed on the outer peripheral wall of the pipe plug, and the pipe plug exhaust groove is provided with a groove opening facing radially outward.
  • the channel peripheral wall of the pipe plug exhaust channel is a closed peripheral wall.
  • the cross section of the pipe plug exhaust passage is semicircular, square or arc-shaped.
  • the pipe plug includes a pipe plug central portion for sealing the nozzle of the liquid sampling pipe and a pipe plug outer portion located radially outside of the pipe plug central portion and provided with an exhaust passage of the pipe plug.
  • the ring part, the outer ring part of the pipe plug is at least partially formed as a loose vent structure.
  • the end of the tube plug is provided with a puncture guide hole for guiding the inner end of the puncture needle to penetrate, and the outer contour shape of the inner end of the puncture needle and the shape of the puncture guide hole are mutually exclusive. match.
  • a peripheral wall vent gap is provided between the liquid sampling tube and the inner peripheral wall of the outer cylinder, and the outer cylinder cavity is in the area of the cylinder cavity between the pipe plug and the puncture needle mounting end.
  • the pipe plug exhaust passage and the peripheral wall exhaust gap are in sequential communication.
  • the outer peripheral wall of the inner end of the puncture needle is provided with a peripheral wall water outlet hole communicating with the needle cavity of the puncture needle.
  • the inner end of the puncture needle is further provided with an axial water outlet hole communicating with the needle cavity in the axial direction, and the axial distance between the hole center of the peripheral wall water outlet hole and the hole center of the axial water outlet hole It is not more than 3mm.
  • a pipe plug exhaust channel at the radially outer edge of the pipe plug, it is possible to communicate the atmospheric environment and the barrel cavity of the outer cylinder between the pipe plug and the mounting end of the puncture needle.
  • a gas plug is formed in the cavity of the outer cylinder, which affects the smooth insertion and removal of the liquid sampling tube assembly, thereby improving the reliability of use.
  • the liquid sampling tube assembly is provided with a tube plug so that the liquid sampling tube lumen is in a negative pressure state.
  • the sampling tube assembly can be pulled out from the outer cylinder cavity as a whole, and the aqueous humor in the sampling tube can be directly detected without further transfer, so it can avoid the The aqueous humor contacts the external environment to ensure the purity of the collected aqueous humor, thereby improving the accuracy of subsequent testing.
  • the present invention provides an aqueous humor collection device, which includes:
  • the outer cylinder including the puncture needle installation end and the liquid collection tube installation end;
  • the puncture needle is fixedly installed at the puncture needle installation end and is provided with an inner end of the puncture needle located in the barrel cavity of the outer cylinder and an outer end of the puncture needle located outside the barrel cavity of the outer cylinder;
  • the liquid sampling tube is inserted into the barrel cavity of the outer cylinder from the installation end of the liquid sampling tube and can be inserted and removed in the axial direction;
  • a pipe plug is arranged in the barrel cavity of the outer cylinder and used to seal the nozzle of the liquid sampling tube.
  • the radial outer edge of the pipe plug is provided with a pipe plug arranged along the extension direction of the outer barrel cavity
  • An exhaust passage which is connected to the barrel cavity area of the outer cylinder body between the pipe plug and the puncture needle installation end.
  • the pipe plug is provided with a plurality of pipe plug exhaust passages that extend along the axial direction of the outer cylinder cavity and are sequentially spaced in the circumferential direction of the pipe plug.
  • a pipe plug exhaust groove serving as the pipe plug exhaust passage is formed on the outer peripheral wall of the pipe plug, and the pipe plug exhaust groove is provided with a groove opening facing radially outward.
  • the channel peripheral wall of the pipe plug exhaust channel is a closed peripheral wall.
  • the cross section of the pipe plug exhaust passage is semicircular, square or arc-shaped.
  • the pipe plug includes a pipe plug central portion for sealing the nozzle of the liquid sampling pipe and a pipe plug outer portion located radially outside of the pipe plug central portion and provided with an exhaust passage of the pipe plug.
  • the ring part, the outer ring part of the pipe plug is at least partially formed as a loose vent structure.
  • the end of the tube plug is provided with a puncture guide hole for guiding the inner end of the puncture needle to penetrate, and the outer contour shape of the inner end of the puncture needle and the shape of the puncture guide hole are mutually exclusive. match.
  • a peripheral wall vent gap is provided between the liquid sampling tube and the inner peripheral wall of the outer cylinder, and the outer cylinder cavity is in the area of the cylinder cavity between the pipe plug and the puncture needle mounting end.
  • the pipe plug exhaust passage and the peripheral wall exhaust gap are in sequential communication.
  • the outer peripheral wall of the inner end of the puncture needle is provided with a peripheral wall water outlet hole communicating with the needle cavity of the puncture needle.
  • the inner end of the puncture needle is further provided with an axial water outlet hole communicating with the needle cavity in the axial direction, and the axial distance between the hole center of the peripheral wall water outlet hole and the hole center of the axial water outlet hole It is not more than 3mm.
  • a pipe plug exhaust channel at the radially outer edge of the pipe plug, it is possible to communicate the atmospheric environment and the barrel cavity of the outer cylinder between the pipe plug and the mounting end of the puncture needle.
  • a gas plug is formed in the cavity of the outer cylinder, which affects the smooth insertion and removal of the liquid sampling tube assembly, thereby improving the reliability of use.
  • the liquid sampling tube assembly is provided with a tube plug so that the liquid sampling tube lumen is in a negative pressure state.
  • the sampling tube assembly can be pulled out from the outer cylinder cavity as a whole, and the aqueous humor in the sampling tube can be directly detected without further transfer, so it can avoid the The aqueous humor contacts the external environment to ensure the purity of the collected aqueous humor, thereby improving the accuracy of subsequent testing.
  • the present invention provides an aqueous humor collection device.
  • the aqueous humor collection device includes an outer cylinder, a puncture needle, and a collection tube assembly.
  • the outer cylinder is provided with a puncture needle mounting end and a collection fluid.
  • Tube installation end, the puncture needle is inserted into the puncture needle installation end and includes an outer end of the puncture needle and an inner end of the puncture needle inserted into the cavity of the outer cylinder.
  • the installation end of the liquid tube is inserted into the cavity of the outer cylinder and includes a pluggable and movable sampling tube and a plug for sealing the nozzle of the sampling tube in the outer cylinder; wherein
  • the aqueous humor collection device also includes an anti-sloshing structure for limiting the displacement of the liquid collection tube assembly along the radial direction of the outer cylinder cavity.
  • the liquid sampling tube assembly further includes a supporting tube rack, the liquid sampling tube is inserted into the inner cavity of the tube rack of the supporting tube rack, and the anti-sloshing structure includes an outer circumference of the supporting tube rack.
  • a wall or a limiting protrusion protruding from the inner peripheral wall of the outer cylinder, and the radial ends of the limiting protrusion are respectively connected to the outer peripheral wall of the support tube frame and the inner peripheral wall of the outer cylinder.
  • liquid sampling tube and the supporting tube frame are fixed by screw connection or snap connection.
  • the limiting protrusion is integrally formed on the outer peripheral wall of the support tube frame; or, the liquid sampling tube assembly includes a tube set sheathed on the outer peripheral wall of the support tube frame, and the limiting protrusion The position protrusion is arranged on the outer peripheral wall of the tube set.
  • the tube set is an elastic tube set.
  • the anti-sloshing structure includes a plurality of the limiting protrusions arranged at intervals in a circumferential direction;
  • the anti-sloshing structure includes the limiting protrusion formed continuously extending in the circumferential direction, between the limiting protrusion and the outer peripheral wall of the supporting tube frame or between the limiting protrusion and the outer cylinder An exhaust gap is formed between the inner peripheral walls.
  • a plurality of the limiting protrusions arranged at intervals along the circumferential direction are all convex points.
  • the limiting protrusion formed continuously extending in the circumferential direction is in a corrugated shape or an oblique tooth shape.
  • the anti-sloshing structure includes limiting protrusions arranged at intervals along the tube length direction of the sampling tube assembly or continuously extending along the tube length direction, and the limiting protrusions are along the tube length direction.
  • the total span is not less than half of the length of the sampling tube.
  • the aqueous humor collection device since the aqueous humor collection device is equipped with an anti-sloshing structure, it can limit its displacement in the radial direction during the process of plugging and unplugging the sampling tube assembly, that is, to ensure that the sampling tube assembly only moves in the axial direction. It can not only ensure that the inner end of the puncture needle accurately pierces the tube plug to be inserted into the lumen of the liquid collection tube, but also ensures that the liquid collection tube assembly is stably pulled out after the aqueous humor collection is completed to avoid the leakage of the aqueous humor in the lumen , Greatly improve reliability.
  • the liquid sampling tube assembly is provided with a tube plug so that the lumen of the liquid sampling tube is in a negative pressure state.
  • the inner end of the puncture needle pierces the tube plug to drain the aqueous humor into the liquid sampling tube lumen, it follows The amount of fluid gradually increases, and the difference between the pressure in the lumen and the pressure in the anterior chamber gradually decreases, so the drainage speed of aqueous humor is gradually reduced, thereby avoiding the dangerous situation of sudden drop in intraocular pressure and greatly improving safety. Furthermore, after the collection is completed, since the liquid sampling tube assembly can be pulled out from the outer cylinder cavity as a whole, and the aqueous humor in the liquid sampling tube can be detected directly, no further transfer is required, so it can avoid the The aqueous humor contacts the external environment to ensure the purity of the collected aqueous humor, thereby improving the accuracy of subsequent testing.
  • the present invention provides a method of collecting aqueous humor from the cornea, including:
  • the aqueous humor in the anterior chamber passes through the puncture needle and flows into the liquid collection tube under the pressure difference between the intraocular pressure and the liquid collection tube;
  • the method includes pushing the rear end of the liquid sampling tube assembly so that the liquid sampling tube in the liquid sampling tube assembly moves toward the inner end of the puncture needle, so that the inner end of the puncture needle is pierced Go through the pipe plug and enter the liquid collection pipe.
  • the method includes holding the aqueous humor collection device with one hand, and gently pushing the rear end of the liquid collection tube assembly with an index finger.
  • the present invention provides a method for collecting aqueous humor from the eyes of a subject, which includes piercing the outer end of the puncture needle of any aqueous humor collection device provided by the present invention into the eye.
  • the method includes pushing the rear end of the liquid sampling tube assembly so that the liquid sampling tube in the liquid sampling tube assembly moves toward the inner end of the puncture needle, so that the inside of the puncture needle The end passes through the pipe plug and enters the liquid collection tube.
  • the method includes holding the aqueous humor collection device with one hand, and gently pushing the rear end of the liquid collection tube assembly with an index finger.
  • the method further includes selecting a negative pressure inside the liquid collection tube, the negative pressure being lower than the intraocular pressure of the subject's eye.
  • Figure 1 is a schematic diagram of a reagent stent in a specific embodiment of the present invention
  • Figure 2 is a schematic diagram of a spring mechanism in a specific embodiment of the present invention.
  • Figure 3 is a schematic diagram of a detection device in a specific embodiment of the present invention.
  • Figure 4 is a schematic diagram of a liquid containing tube in a specific embodiment of the present invention.
  • Fig. 5 is a schematic diagram of a liquid withdrawal needle in a specific embodiment of the present invention.
  • Figure 6 is a perspective view of an aqueous humor collection device in a specific embodiment of the present invention.
  • Figure 7 is a front view of the aqueous humor collection device in Figure 6;
  • Figure 8 is a main cross-sectional view of the aqueous humor collection device in Figure 7 when the puncture needle does not pierce the tube plug;
  • Figure 9 is a main cross-sectional view of the aqueous humor collection device in Figure 8 when a puncture-proof partition is provided;
  • Figure 10 is a cross-sectional view of the aqueous humor collection device in Figure 6;
  • Fig. 11 is a schematic structural diagram of the puncture needle of the aqueous humor collection device in Fig. 8 when a peripheral wall water outlet hole is provided;
  • Fig. 12 is a schematic structural diagram of the pipe plug of the aqueous humor collection device in Fig. 8 provided with a semicircular pipe plug exhaust passage with an open peripheral wall;
  • Fig. 13 is a schematic structural diagram of the pipe plug of the aqueous humor collection device in Fig. 8 provided with an open peripheral wall and a semi-rectangular pipe plug exhaust channel;
  • Fig. 14 is a schematic structural diagram of the pipe plug of the aqueous humor collection device in Fig. 8 when a peripheral wall closed and circular pipe plug exhaust channel is provided;
  • FIG. 15 is a schematic diagram of the structure of the pipe plug of the aqueous humor collection device in FIG. 8 when a peripheral wall closed and arc-shaped pipe plug exhaust channel is provided;
  • FIG. 16 is a schematic structural diagram of the liquid collection tube and the supporting tube frame of the aqueous humor collection device in FIG. 8 when connected by a buckle;
  • FIG. 17 is a schematic structural view of the liquid collection tube of the aqueous humor collection device in the specific embodiment of the present invention when a convex point-like limiting protrusion is integrally formed;
  • FIG. 18 is a schematic diagram of the structure of the liquid collection tube of the aqueous humor collection device in the specific embodiment of the present invention when a corrugated limiting protrusion is integrally formed;
  • FIG. 19 is a schematic structural view of the liquid collection tube of the aqueous humor collection device in the specific embodiment of the present invention when the tube kit is sheathed and the limiting protrusion is in the shape of a convex point;
  • FIG. 20 is a schematic structural diagram of the liquid collection tube of the aqueous humor collection device in the specific embodiment of the present invention when the tube kit is sheathed and the limiting protrusion is corrugated;
  • 21 is a schematic structural view of the liquid collection tube of the aqueous humor collection device according to the specific embodiment of the present invention when the tube kit is sheathed and the limiting protrusion is in the shape of an oblique tooth;
  • FIG. 22 is a schematic diagram of the structure when the supporting tube frame of the aqueous humor collection device in the specific embodiment of the present invention is integrally formed with a convex point-shaped limiting protrusion;
  • FIG. 23 is a schematic structural diagram of the supporting pipe frame of the aqueous humor collection device in the specific embodiment of the present invention when a corrugated limiting protrusion is integrally formed;
  • FIG. 24 is a schematic diagram of the structure when the supporting tube frame of the aqueous humor collection device in the specific embodiment of the present invention is integrally formed with oblique tooth-shaped limiting protrusions;
  • 25 is a schematic structural diagram of the supporting tube frame of the aqueous humor collection device in the specific embodiment of the present invention when the tube kit is sheathed and the limiting protrusion is in the shape of a convex point;
  • 26 is a schematic structural diagram of the supporting tube frame of the aqueous humor collection device in the specific embodiment of the present invention when the tube kit is sheathed and the limiting protrusion is corrugated;
  • FIG. 27 is a schematic structural diagram of the supporting tube frame of the aqueous humor collection device in the specific embodiment of the present invention when the tube kit is sheathed and the limiting protrusion is in the shape of a helical tooth;
  • Figure 28 is a schematic structural diagram of a conversion socket in a specific embodiment of the present invention.
  • ADTV absolute deviation from the target volume
  • FIG. 30 is a schematic diagram of the operation time of each subgroup in the animal experiment in the specific embodiment of the present invention.
  • FIG. 31 is a schematic diagram of the anterior segment evaluation of the representative rabbits of the first group in the animal experiment in the specific embodiment of the present invention.
  • orientation words used such as "up, down, top, bottom" are usually for the direction shown in the drawings or for vertical, vertical or The terms used to describe the mutual positional relationship of the components in the direction of gravity.
  • the present invention provides a reagent holder 9 which can be configured as a bar-shaped holder as shown in the figure.
  • the reagent holder 9 includes a holder body and a functional position provided on the holder body.
  • the functional position includes a liquid-containing tube insertion hole 91 and an elastic member.
  • the elastic member is configured as follows: In the case of the liquid receiving tube 106, it can elastically act on the liquid receiving tube 106, so that the liquid receiving tube 106 can elastically move along the direction of the center axis of the liquid receiving tube insertion hole 91.
  • the liquid containing tube 106 is affected by the elasticity of the elastic member in the reagent holder 9 It can move elastically along the central axis of the liquid-containing tube insertion hole 91, thereby converting the rigid collision between the liquid taking device and the bottom wall of the liquid-containing tube 106 into an elastic collision.
  • the detection equipment will not Trigger the striker protection function.
  • the reagent holder 9 of the present invention is used to elastically fix the liquid receiving tube 106, the depth of the liquid taking device extending into the lumen of the liquid receiving tube 106 can be greatly increased, thereby effectively increasing the sample extraction volume.
  • the functional position further includes a functional position outer sleeve 92 which protrudes downward from the inner peripheral wall of the liquid receiving tube insertion hole 91 in the direction of the central axis of the hole.
  • the elastic component can be arranged in the sleeve cavity of the outer sleeve 92 at the functional position, for example, can be arranged at the bottom or the periphery of the sleeve cavity, as long as it is ensured that the liquid container 106 can be inserted along the liquid container hole 91 The hole center axis direction can be elastically moved.
  • the elastic member may be configured as a spring mechanism 93 or an elastic medium.
  • the elastic medium can be filled between the inner wall of the outer sleeve 92 of the functional position and the outer wall of the liquid receiving tube 106.
  • the spring mechanism 93 can be set at the bottom of the sleeve cavity of the outer sleeve 92 at the functional position and the spring mechanism 93 can be elastically moved along the direction of the central axis of the hole And during the elastic movement of the spring mechanism 93, the outer periphery of the spring mechanism 93 can be set to at least partially fit the inner peripheral wall of the sleeve cavity to slide, so as to ensure that the elastic force acting on the liquid containing tube 106 is always along The direction of the hole center axis of the liquid receiving tube insertion hole 91.
  • a support recess 93a may be provided in the center of the top of the elastic component, and the support recess 93a is used to support the liquid The bottom of the tube 106.
  • the outer contour of the bottom of the liquid receiving tube 106 can be set to have an inverted cone shape.
  • the shape of the supporting recess 93 a matches the outer contour of the bottom of the liquid receiving tube 106.
  • the present invention provides a liquid-containing tube adapter, which is characterized in that it comprises an adapter body and a liquid-containing tube placement position arranged on the adapter body, and the adapter body is arranged to be installed in the sample processing unit. Or the functional position on or inside the analytical instrument, the liquid containing tube placement position is set to accommodate the liquid containing tube with an outer diameter of 3mm to 8mm and a length of 20mm to 30mm, and the liquid containing tube and the functional position The relative position is fixed by the liquid containing tube adapter.
  • the adapter body is configured to be detachably installed in the functional position.
  • the adapter body is configured to be fixedly installed in the functional position.
  • the liquid receiving tube is detachably inserted into the liquid receiving position.
  • the outer peripheral part of the adaptor body at least partially fits the inner peripheral wall of the functional position.
  • the outer peripheral portion of the liquid receiving tube is at least partially attached to the inner peripheral wall of the adapter body and/or the inner peripheral wall of the liquid receiving position.
  • the sample processing or analysis instrument includes a centrifuge, a spectrometer, and other instruments.
  • the liquid-containing tube placement position includes a liquid-containing tube insertion hole.
  • the liquid-containing tube placement position further includes an elastic member configured to be able to elastically act on the liquid-containing tube when the liquid-containing tube is inserted in the liquid-containing tube insertion hole.
  • the liquid receiving tube can be elastically moved along the central axis of the insertion hole of the liquid receiving tube.
  • the liquid-containing tube placement position further includes an outer sleeve, the outer sleeve is arranged along the inner circumferential wall of the liquid-containing tube insertion hole, and the elastic member is located in the sleeve of the outer sleeve. The cavity of the tube.
  • the liquid-containing tube placement position further includes an outer sleeve, the outer sleeve is arranged along the inner peripheral wall of the liquid-containing tube insertion hole, and is inserted into the liquid-containing tube insertion hole.
  • the outer sleeve can elastically act on the liquid receiving tube, so that the liquid receiving tube can elastically move along the central axis of the insertion hole of the liquid receiving tube.
  • the present invention provides a combination, which is characterized by comprising a liquid receiving tube and any liquid receiving tube adapter provided according to the present invention.
  • the reagent holder 9 further includes a conversion socket 914 that is detachably inserted into the liquid-containing tube insertion hole 91.
  • the conversion socket 914 includes a support sleeve portion 914a connected up and down and an extension Sleeve 914b.
  • the sleeve cavity of the supporting sleeve portion 914a and the sleeve cavity of the extension sleeve portion 914b are connected up and down and jointly formed as a conversion inserting cavity, which is used for detachably inserting the liquid receiving tube 106.
  • the aforementioned elastic member can be arranged in the conversion insertion cavity of the conversion socket 914, so that the depth of the liquid taking device extending into the lumen of the liquid receiving tube 106 can be greatly increased, thereby effectively increasing the sample extraction volume.
  • the functional positions may include sample positions 95, reagent positions 98, photometric positions 99, reaction positions 910 or reserved positions 912, etc., which can be set according to actual detection requirements.
  • the present invention provides a detection device assembly, which includes a detection device 10, a liquid containing tube 106, and the reagent holder 9 described above.
  • the liquid receiving tube 106 is detachably inserted into the liquid receiving tube insertion hole 91 and can be elastically acted by the elastic member to move elastically along the central axis of the liquid receiving tube insertion hole 91.
  • the liquid containing tube 106 can pass through the liquid containing tube insertion hole 91 to be inserted into the sleeve cavity of the functional position outer sleeve 92, and preferably, this
  • the top end of the liquid receiving tube 106 is not higher than the opening of the liquid receiving tube insertion hole 91, and the outer diameter of the liquid receiving tube 106 is the same as the inner diameter of the inner cavity of the sleeve to prevent the liquid receiving tube 106 from shaking and improve its Installation stability.
  • the detection device 10 includes a liquid taking device configured to extend into the lumen of the liquid containing tube 106 to take liquid, for example, the liquid taking device may be provided with a liquid taking device for extending into the lumen of the liquid containing tube 106 The liquid taking needle 104 for taking liquid.
  • the detection device 10 is provided with a striker protection function, which can cause the detection device 10 to report an error and stop working when the liquid withdrawal needle 104 receives a rigid collision.
  • a striker protection function which can cause the detection device 10 to report an error and stop working when the liquid withdrawal needle 104 receives a rigid collision.
  • the liquid receiving tube 106 is subjected to the elastic action of the elastic member, when the liquid taking needle 104 touches the bottom wall of the liquid receiving tube 106, the rigid collision can be converted into an elastic collision, thereby avoiding triggering during liquid taking.
  • the striker protection function so the liquid taking needle 104 can extend into a deeper position to take liquid, thereby increasing the extraction volume.
  • the liquid taking needle 104 can take liquid smoothly when it touches the bottom wall of the liquid containing tube 106, the liquid taking needle 104 can be redesigned.
  • the reason is that the existing liquid taking needle 104 is provided with a liquid taking port
  • the outer end surface of the tube 106 is a flat end surface, and the bottom wall of the liquid receiving tube 106 is usually a flat wall. When the flat end surface and the flat wall are in contact, the two tend to form close contact and cause the liquid extraction port to be sealed. liquid.
  • the outer end surface of the liquid taking needle 104 may be formed as an inclined end surface 104a, and the inclined end surface 104a is formed with a liquid withdrawal port.
  • the detection equipment assembly of the present invention is beneficial to increase the sample extraction amount during liquid extraction and can ensure smooth liquid extraction during the liquid extraction process.
  • the liquid taking needle 104 extends along a straight line and includes a needle body section and a needle section that are connected to each other.
  • the outer end of the needle section is formed with a liquid taking port. Since the outer end surface of the needle section is an inclined end surface, refer to FIG. 5 ,
  • the central axis 104b of the needle body section of the needle body section intersects the central axis 104c of the liquid taking port of the liquid taking port.
  • the acute angle formed by the intersection of the central axis 104b of the needle body section and the central axis 104c of the liquid intake is ⁇ , and ⁇ may satisfy: 0 ⁇ 0.1°.
  • the inclined end surface 104a can be set to a curved surface or a flat surface, or the inner bottom wall of the lumen of the liquid receiving tube 106 can be set to a flat wall or a curved wall, as long as it is ensured that the liquid taking needle 104 is at the bottom of the liquid receiving tube 106. When the wall is in contact, it is sufficient to ensure the non-sealed state of the liquid intake.
  • the following uses a chemiluminescence immunoassay for aqueous humor sample detection as an example to illustrate the detection process of the detection device assembly of the present invention, but it should be understood that the detection device assembly of the present invention can also be equipped with other types or fields.
  • the detection equipment is not limited to the chemiluminescence immunoassay analyzer.
  • the reagent holder 9 is in a strip shape and can be provided with a left anchor sheet 94, a sample position 95, a dilution position 96, a washing solution position 97, and a reagent position 98 arranged in order from left to right. , Photometric position 99, reaction position 910, substrate position 911, reserved position 912, and right anchor piece 913.
  • the order of the function bits can also be set separately according to actual conditions.
  • the sample position is used to place the liquid collection tube
  • the reagent position is used to preload reagents
  • the photometric position is used to detect optical signals
  • the reaction position is used to react each component
  • the reserved position is used to expand and spare for other types of tests.
  • the chemiluminescence immunoassay analyzer includes a housing 101, a reaction chamber 102, a door 103, the above-mentioned liquid taking needle 104 and a reagent holder 105.
  • the door 103 of the reaction chamber 102 is opened, the reagent holder 9 with the liquid containing tube 106 is inserted into the reagent holder position 105, and the door 103 is closed. Then start the detection.
  • the chemiluminescence immunoassay analyzer first takes the aqueous humor sample and reagents from the corresponding positions through the liquid withdrawal needle 104 and adds them to the reaction position 910 for a warm bath, then transfers to the washing liquid position 97 for cleaning, and then transfers to the substrate Position 911 is catalyzed, and finally transferred to photometry position 99 for photometry.
  • the present invention provides an aqueous humor collection device, which includes an outer cylinder 1, a puncture needle 2, and a collection tube assembly 3.
  • the outer cylinder 1 is provided with a puncture needle installation end and a liquid sampling tube installation end at both ends in the axial direction.
  • the puncture needle 2 can be fixedly installed at the installation end of the puncture needle, and the fixed installation can be a fixed connection or a detachable connection.
  • the puncture needle may be provided with an inner end of the puncture needle located in the cavity of the outer cylinder and an outer end of the puncture needle located outside the cavity of the outer cylinder.
  • the sampling tube assembly 3 may include a sampling tube 31 inserted from the installation end of the sampling tube into the barrel cavity of the outer cylinder and capable of being inserted and removed in the axial direction, and arranged in the outer cylinder cavity for sealing the sampling tube. ⁇ 33 ⁇ Port of the pipe plug 33.
  • the tube plug 33 is in direct contact with the inner peripheral wall of the outer cylinder while the sampling tube 31 is not in direct contact with the inner peripheral wall of the outer cylinder.
  • the tube plug 33 forms a slidable contact with the inner peripheral wall of the outer cylinder, such as a slidable contact with a certain contact resistance, to control the insertion and removal of the liquid sampling tube 31 along the axial direction of the outer cylinder cavity and keep it stable Sex.
  • the static friction coefficient between the tube plug 33 and the inner peripheral wall of the outer cylinder is ⁇ 1
  • the static friction coefficient between the tube plug 33 and the nozzle of the liquid sampling tube is ⁇ 2, and satisfies: ⁇ 1 ⁇ 2.
  • the pipe plug 33 may be spaced apart from the inner peripheral wall of the outer cylinder to ensure that the pipe plug 33 and the inner peripheral wall of the outer cylinder do not directly contact each other.
  • the liquid sampling tube 31 is in direct contact with the inner peripheral wall of the outer cylinder, and the tube plug 33 is not in direct contact with the inner peripheral wall of the outer cylinder.
  • the liquid sampling tube 31 (for example, the outer periphery of the nozzle of the liquid sampling tube) may form a slidable contact with the inner peripheral wall of the outer cylinder, such as a slidable contact with a certain contact resistance, to control the liquid sampling tube along the outer cylinder.
  • the cylinder cavity moves axially and maintains its stability.
  • the pipe plug 33 and the liquid sampling tube 31 are arranged at intervals on the inner peripheral wall of the outer cylinder to ensure that the plug 33 and the liquid sampling tube 31 and the inner peripheral wall of the outer cylinder do not directly contact each other.
  • the aqueous humor collection device may include a support tube frame 32 for fixed installation of the liquid collection tube 31.
  • the outer peripheral wall of the support tube frame forms a slidable contact with the inner peripheral wall of the outer cylinder, such as a slidable contact with a certain contact resistance.
  • the fluid collection tube assembly 3 can be moved toward the inner end of the puncture needle, so that the inner end of the puncture needle pierces the soft sleeve 8 and the tube plug 33 are inserted into the lumen of the liquid collection tube to drain the aqueous humor in the anterior chamber to the lumen of the liquid collection tube through the outer end of the puncture needle and the inner end of the puncture needle.
  • a marking line can be provided on the liquid sampling tube 31 to mark the optimal moving distance of the liquid sampling tube 31, so that when the inner end of the puncture needle pierces the tube plug 33, the finger does not need to exert excessive force to affect the liquid sampling tube and the tube.
  • the aqueous humor collection device may include a limiting protrusion 6 to facilitate the stability of the liquid collection tube and the tube plug along the axial movement of the outer cylinder cavity.
  • the sampling tube assembly 3 can be pulled out from the outer cylinder cavity as a whole, and then the sampling tube 31 can be directly placed in a specific testing instrument for specific item testing, and Compared with the prior art, there is no need to further transfer the collected aqueous humor, so the aqueous humor in the lumen of the liquid collection tube can be prevented from contacting the external environment, and the purity of the collected aqueous humor can be guaranteed, thereby improving the accuracy of subsequent detection. Performance and reliability, and can avoid the waste caused by the transfer of aqueous humor.
  • the static friction coefficient ⁇ 1 between the pipe plug 33 and the inner peripheral wall of the outer cylinder is smaller than the static friction coefficient between the pipe plug 33 and the nozzle of the sampling tube, which is ⁇ 2, or the pipe plug 33 is spaced apart from
  • the inner peripheral wall of the outer cylinder is arranged to ensure that when the liquid sampling tube assembly 3 is pulled out from the outer cylinder cavity as a whole, the pipe plug 33 will always tightly block the nozzle of the liquid sampling tube, thereby more reliably ensuring the collected room The purity of the water.
  • the pipe plug 33 and the inner peripheral wall of the outer cylinder are preferably arranged in contact with each other through a smooth surface.
  • the radially outer end surface of the pipe plug 33 or the inner peripheral wall surface of the outer cylinder can be set as a smooth surface, or the radial outer end surface of the pipe plug 33 and the inner peripheral wall surface of the outer cylinder can be set as smooth surfaces at the same time.
  • the aqueous humor collection device includes an anti-sloshing structure for limiting the displacement of the liquid sampling tube assembly 3 along the radial direction of the outer cylinder cavity.
  • the anti-sloshing structure helps the liquid sampling tube assembly to move in the axial direction during the plug-in movement process without or without radial sloshing.
  • the liquid sampling tube assembly 3 only moves in the axial direction during the insertion and removal movement without radial shaking, which not only ensures that the inner end of the puncture needle accurately pierces the tube plug during the puncture process 33 to be inserted into the lumen of the liquid collection tube, which can ensure that the liquid collection tube assembly 3 is stably pulled out after the aqueous humor collection is completed, so as to avoid the leakage of aqueous humor in the liquid collection tube lumen, thereby further improving the accuracy of subsequent detection Sex and reliability.
  • the anti-sloshing structure may include an annular groove 35 formed on the outer peripheral wall of the liquid sampling tube assembly 3 and an annular stopper 37 provided in the hoop annular groove 35 , The radially outer end of the annular stopper 37 abuts against the inner peripheral wall of the outer cylinder. It should be noted that, in addition to preventing the radial sloshing of the liquid sampling tube assembly 3, the annular stopper 37 can make the inner end of the puncture needle pierce the tube plug 33 more accurately and prevent deviation during the puncture process.
  • the stability and reliability of the puncture drainage process are effectively improved.
  • the liquid sampling tube assembly 3 can be prevented from being separated from the outer cylinder when the aqueous humor collection device is taken, thereby improving the reliability of the product.
  • multiple sets of annular grooves 35 and corresponding annular stoppers 37 can be provided to obtain better effects.
  • the aqueous humor collection method of the present invention includes pushing the rear end of the liquid collection tube assembly to move the liquid collection tube toward the inner end of the puncture needle after the outer end of the puncture needle penetrates the anterior chamber of the eye, so that the puncture needle The inner end pierces the soft sleeve 8 and the tube plug 33 and then is inserted into the lumen of the liquid collection tube.
  • the soft sleeve originally covering the inner end of the puncture needle inserted into the lumen of the liquid collection tube is compressed by the tube plug to generate resilience.
  • the pressure of the aqueous humor in the anterior chamber in the lumen of the liquid collection tube and the pressure in the anterior chamber Under the action of the difference, the outer end of the puncture needle and the inner end of the puncture needle are drained to the lumen of the liquid collection tube.
  • the pressure in the lumen and the pressure in the anterior chamber tend to reach equilibrium, and the aqueous humor gradually stops draining to the lumen of the fluid collection tube through the puncture needle.
  • the time from the insertion of the inner end of the puncture needle into the lumen of the fluid collection tube until the pressure in the lumen and the pressure in the anterior chamber reach equilibrium and/or the time required for the drainage of aqueous humor to stop is or about 1 s, 2 s, 3s, 4s, 5s, 6s, 7s, 8s, 9s, 10s, 11s, 12s, 13s, 14s, 15s, 16s, 17s, 18s, 19s, 20s, 21s, 22s, 23s, 24s, 25s, 26s, 27s, 28s, 29s, 30s or longer.
  • the aqueous humor collection method of the present invention includes keeping the inner end of the puncture needle inserted into the lumen of the liquid collection tube after the outer end of the puncture needle penetrates the anterior chamber of the eye and the inner end of the puncture needle is inserted into the lumen of the liquid collection tube Steps within a period of time.
  • keeping the inner end of the puncture needle inserted into the lumen of the liquid collection tube may include maintaining or applying an external force to the liquid collection tube assembly 3 to prevent the inner end of the puncture needle from popping out of the liquid collection tube lumen.
  • maintaining or applying an external force to the fluid collection tube assembly 3 can continue until the pressure in the lumen and the pressure in the anterior chamber reach equilibrium.
  • maintaining or applying an external force to the liquid collection tube assembly 3 can continue until the drainage of aqueous humor stops.
  • the timing starts from the insertion of the inner end of the puncture needle into the lumen of the liquid collection tube, and the insertion of the inner end of the puncture needle into the lumen of the liquid collection tube can last or last for about 1s, 2s, 3s, 4s, 5s, 6s, 7s, 8s, 9s, 10s, 11s, 12s, 13s, 14s, 15s, 16s, 17s, 18s, 19s, 20s, 21s, 22s, 23s, 24s, 25s, 26s, 27s, 28s, 29s, 30s or longer.
  • the maintenance or application of external force to the liquid collection tube assembly 3 can continue or last for about 1s, 2s, 3s, 4s, 5s, 6s, 7s, 8s, 9s, 10s, 11s, 12s, 13s, 14s, 15s, 16s, 17s, 18s, 19s, 20s, 21s, 22s, 23s, 24s, 25s, 26s, 27s, 28s, 29s, 30s or longer.
  • the collection tube assembly can rebound, so that the inner end of the puncture needle naturally ejects the collection tube assembly. Liquid pipe lumen and pipe plug.
  • the friction between the inner end of the puncture needle and the soft sleeve 8 can be reduced, and the inner end of the puncture needle and the pierced tube plug
  • the sum of the friction force between the ring 33 and the friction force between the annular limiter 37 and the inner peripheral wall of the outer cylinder is set to be less than the resilience force of the soft sleeve 8, so that the outer end of the puncture needle exits the anterior chamber and the index finger loosens the extraction fluid pipe assembly 3
  • the inner end of the posterior puncture needle can naturally eject the liquid collection tube lumen and the tube plug, and there is no need to pull out the liquid collection tube assembly 3 to make the inner end of the puncture needle exit the liquid collection tube lumen and the tube plug, thereby simplifying the operation.
  • the soft sleeve 8 can also be set as a spring structure or a soft sleeve containing a spring structure, which can not only ensure the stable deformation of the soft sleeve 8 during the puncture process, but also improve the stability of the rebound force of the soft sleeve 8 when it rebounds. It is further helpful for the liquid sampling tube assembly to move along the axial direction during the insertion and removal movement process, so as to reduce or avoid radial shaking.
  • the annular limiter 37 in order to reduce production difficulty and production cost, can be preferably set as an easy-to-obtain, inexpensive and good-quality rubber band or other elastic ring, and the annular limiter 37 made of elastic material It forms elastic contact with the inner peripheral wall of the outer cylinder, which can avoid excessive friction and abrasion of the inner peripheral wall of the outer cylinder.
  • a groove vent 36 penetrating along the axial direction of the outer cylinder cavity may be formed on the groove side wall of the annular groove 35, so that the outer cylinder cavity is mounted on the pipe plug 33 and the puncture needle.
  • the barrel cavity area between the ends can communicate with the atmosphere through the groove vent 36 to avoid the formation of air plugs in the outer barrel cavity and affect the smooth plugging and unplugging of the liquid sampling tube assembly 3, thereby improving the performance of the aqueous humor collection device Use reliability.
  • the anti-sloshing structure may further include a limiting protrusion 6 protruding from the outer peripheral wall of the liquid sampling tube assembly 3 or from the inner peripheral wall of the outer cylinder.
  • the radial ends of 6 are respectively connected to the outer peripheral wall of the liquid sampling tube assembly 3 and the inner circumferential wall of the outer cylinder, thereby preventing the liquid sampling tube assembly 3 from sloshing radially.
  • the limiting protrusion 6 when the limiting protrusion 6 is provided on the outer peripheral wall of the liquid sampling tube assembly 3, the limiting protrusion 6 may be integrally formed on the outer peripheral wall of the liquid sampling tube 31.
  • a tube set 34 sheathed on the outer peripheral wall of the liquid sampling tube 31 can be provided in the sampling tube assembly 3, and the limiting protrusion 6 can be provided on the outer peripheral wall of the tube set 34, because the tube set 34 is detachable Therefore, it can be reused, and it is relatively less difficult to form the limiting protrusion 6 on the tube sleeve 34, which is more conducive to reducing production costs.
  • the tube set 34 may be configured as an elastic tube set to prevent the liquid collection tube 31 from rupturing due to rigid contact when subjected to a radial restriction, thereby reducing the risk of aqueous humor leakage.
  • the anti-sloshing structure may include a plurality of limiting protrusions 6 arranged at intervals in the circumferential direction to ensure that the liquid sampling tube 31 is coaxially arranged with the outer cylinder cavity, thereby ensuring that the liquid sampling tube 31 is arranged along the Axial smooth plug-in movement.
  • a vent gap is formed between the plurality of spacing protrusions 6 spaced apart, the barrel cavity of the outer cylinder body between the puncture needle installation end and the pipe plug 33 can communicate with the atmosphere through the vent gap , Thereby avoiding the formation of a gas plug in the cavity of the outer cylinder and affecting the smooth insertion and removal of the liquid sampling tube assembly 3.
  • a plurality of limiting protrusions 6 arranged at intervals along the circumferential direction may be arranged in a convex point shape.
  • the limiting protrusion 6 can also be continuously extended in the circumferential direction.
  • an exhaust gap is preferably formed between the limiting protrusion 6 and the outer peripheral wall of the liquid sampling tube assembly 3 to avoid the formation of a gas plug.
  • an exhaust gap is also preferably formed between the limiting protrusion 6 and the inner peripheral wall of the outer cylinder.
  • the limiting protrusion 6 continuously extending in the circumferential direction may be provided in a corrugated shape or a helical tooth shape.
  • the limiting protrusions 6 are arranged at intervals along the tube length direction of the liquid sampling tube assembly 3, or they are continuously extended and formed along the tube length direction.
  • the liquid sampling tube assembly 3 further includes a supporting tube frame 32 for fixing the liquid sampling tube 31.
  • the anti-sloshing structure can be arranged between the outer peripheral wall of the support pipe frame 32 and the inner peripheral wall of the outer cylinder, for example, as shown in FIGS. 22 to 27.
  • the supporting tube frame 32 can better improve the stability of the liquid sampling tube assembly 3 and reduce the risk of the liquid sampling tube assembly 3 being broken due to collision or pressing.
  • the liquid sampling tube needs to be taken out separately, so the connection between the liquid sampling tube 31 and the support tube frame 32 must meet the requirements of stability and quick disassembly.
  • the liquid sampling tube 31 and the support tube frame 32 can be fixed by screw connection or snap connection.
  • the sampling tube 31 and the supporting tube frame 32 are connected by a snap.
  • the sampling tube 31 needs to be inserted into the supporting tube frame 32, the sampling tube 31 is pushed to the right until the tube The rack buckle 321 is clamped into the liquid collection tube clamping groove 311, so that the liquid collection tube 31 and the supporting tube rack 32 can be locked and locked with each other.
  • the tube rack buckle button 322 can be pressed to lift the tube rack buckle 321 to escape the liquid sampling tube clamping groove 311, and the liquid sampling tube 31 can be quickly taken out from the supporting tube rack 32.
  • the aqueous humor collection device further includes a needle holder 4 for fixing the puncture needle 2.
  • the outer end of the puncture needle protrudes from the outer end of the needle holder and the inner end of the puncture needle protrudes from the inner end of the needle holder, and a quick plug-in connection is formed between the inner end of the needle holder and the installation end of the puncture needle, which helps reduce the difficulty of installation. Thereby improving assembly efficiency.
  • a threaded connection or a snap-fit connection can be formed between the inner end of the needle holder and the puncture needle installation end.
  • the aqueous humor collection device further includes an anti-puncture spacer 5 for isolating the inner end of the puncture needle and the plug 33 from each other along the axial direction of the outer cylinder cavity to It prevents the inner end of the puncture needle from piercing the tube plug 33 when the aqueous humor collection device is not used for anterior chamber puncture, which effectively prevents the device from failing before being used.
  • the puncture-proof partition 5 can prevent the aqueous humor collection device from failing.
  • the puncture-proof partition 5 is set as a detachable piece, and the puncture-proof partition 5 can be removed before the puncture.
  • a spacer inserting groove 11 can be provided on the peripheral wall of the outer cylinder 1, and the spacer inserting groove 11 and the outer cylinder cavity are located between the inner end of the puncture needle and the pipe plug 33.
  • the areas communicate with each other, and the anti-puncture spacer 5 can be inserted into the barrel cavity area through the spacer insertion slot 11, and placed between the inner end of the puncture needle and the tube plug 33, thereby connecting the inner end of the puncture needle and the tube plug 33 33 are isolated from each other.
  • the puncture-proof spacer 5 needs to be removed, it can be quickly pulled out from the spacer insertion slot 11, which is quite convenient for operation.
  • the aqueous humor collection device further includes a detachable limit structure to prevent the inner end of the puncture needle from piercing the pipe plug and invalidating the aqueous humor collection device due to vibration or misoperation by medical staff during transportation. And/or the liquid sampling tube assembly 3 falls off from the outer cylinder.
  • the limiting structure is located at the rear end of the supporting pipe rack.
  • the limit structure is located at the installation end of the liquid collection tube of the outer cylinder.
  • the limiting structure in a packaged or unused aqueous humor collection device, at least a part of the limiting structure is located between the installation end of the liquid sampling tube of the outer cylinder and the rear end of the supporting tube frame.
  • the limiting structure may include The blocking block sleeved at the back end of the support tube frame is clamped between the installation end of the liquid sampling tube of the outer cylinder and the back end of the support tube frame.
  • the limiting structure can prevent the axial relative displacement of the support tube frame and the outer cylinder, so as to prevent the inner end of the puncture needle from piercing the tube plug 33 when the aqueous humor collection device is not used for anterior chamber puncture. And/or prevent the liquid sampling tube assembly 3 from falling off the outer cylinder due to gravity or external force.
  • the limiting structure is a detachable piece, which can be removed before puncturing.
  • the tube plug 33 in order to better avoid the formation of a gas plug in the cavity of the outer cylinder and affecting the smooth insertion and removal of the liquid collection tube assembly 3, the tube plug 33 can be placed radially outward
  • the rim forms a pipe plug exhaust passage 331 arranged along the extension direction of the outer barrel cavity, and the barrel cavity area of the outer barrel cavity between the pipe plug 33 and the puncture needle installation end can pass through the pipe plug exhaust passage 331
  • the peripheral wall exhaust gap between the above-mentioned liquid sampling tube 31 and the inner peripheral wall of the outer cylinder communicates with the atmosphere.
  • the barrel cavity of the outer cylinder is in the barrel cavity area between the pipe plug 33 and the puncture needle mounting end, the pipe plug exhaust passage 331 and the peripheral wall exhaust gap are in sequence connected, and the atmospheric environment is connected in sequence.
  • a plurality of pipe plugs that extend along the axial direction of the outer cylinder cavity and are arranged at intervals along the circumference of the pipe plug 33 are provided. Exhaust passage 331.
  • a pipe plug exhaust groove as a pipe plug exhaust passage 331 may be formed on the outer peripheral wall of the pipe plug 33, and the pipe plug exhaust groove is provided with a facing diameter. Open to the groove on the outside.
  • the plug exhaust passage 331 may be set as an exhaust passage with an open peripheral wall.
  • the peripheral wall of the pipe plug exhaust channel 331 can be set as a closed peripheral wall, that is, the pipe plug exhaust channel 331 can be set as a peripheral wall closed exhaust channel.
  • the cross-section of the pipe plug exhaust passage 331 can be set to have different shapes such as a semicircle, a square or an arc.
  • the pipe plug 33 includes a pipe plug center portion for sealing the nozzle of the liquid extraction pipe and an outer ring portion of the pipe plug located radially outside the pipe plug center portion and provided with a pipe plug exhaust channel 331, which is To ensure internal and external ventilation, the outer ring portion of the pipe plug can be at least partially set as a loose ventilation structure, but it is still necessary to ensure that the central portion of the pipe plug has a tightness.
  • a puncture for guiding the penetration of the inner end of the puncture needle may be provided at the end of the tube plug 33.
  • the blind guide hole 332 is broken, and the outer contour shape of the inner end of the puncture needle matches the shape of the blind guide hole 332.
  • the inner end of the puncture needle and the puncture blind guide hole 332 may be set in a long tapered shape that matches with each other.
  • the peripheral wall water outlet hole 21 communicating with the needle cavity of the puncture needle 2 can be provided on the outer peripheral wall of the inner end of the puncture needle.
  • the aqueous humor can also flow out into the lumen of the liquid collection tube through the water outlet hole 21 on the peripheral wall, thereby ensuring the working reliability of the device.
  • the axial distance between the peripheral wall outlet hole 21 and the axial outlet hole 22 should not be too large, otherwise when the axial outlet hole 22 is inserted into the lumen of the liquid sampling tube, the peripheral wall outlet hole 21 is still located in the pipe plug 33 and is blocked. As a result, the water outlet hole 21 of the peripheral wall loses its effectiveness.
  • the axial distance between the hole center of the peripheral wall water outlet hole 21 and the hole center of the axial water outlet hole 22 may be preferably set to be no more than 3 mm, so as to ensure that when the axial water outlet hole 22 is inserted into the liquid collection After the tube lumen, the water outlet hole 21 of the peripheral wall can also be located in the lumen of the liquid collection tube without being blocked.
  • the outer diameter of the puncture needle 2 can be set to 0.31 mm (30G) to 0.91 mm (20G) and the inner diameter can be adjusted according to the outer diameter.
  • the outer diameter of the puncture needle 2 can be set to 0.5 mm (25G) and the inner diameter is at least about 0.232 mm.
  • the outer diameter of the puncture needle 2 is or is approximately 0.3mm, 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm or 0.9mm.
  • the inner diameter of the puncture needle 2 is 0.15 mm to 0.45 mm, for example, the inner diameter of the puncture needle 2 is or is about 0.1 mm, 0.2 mm, 0.3 mm, or 0.4 mm.
  • the total length of the puncture needle 2 can be set to be 20 mm to 65 mm, for example, the total length of the puncture needle 2 is or is about 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, 50 mm, 55 mm, or 60 mm.
  • the protruding length of the puncture needle 2 from the needle seat 4 can be set to be 1.5mm to 15mm, for example, 1.5mm to 5mm, 5mm to 7.5mm, 7.5mm to 10mm, 10mm to 12.5mm or 12.5mm. To 15mm, preferably 6mm.
  • the protruding length of the puncture needle 2 inwardly from the needle hub 4 can be set to 10 mm to 30 mm, for example, 10 mm to 15 mm, 15 mm to 20 mm, 20 mm to 25 mm, or 25 mm to 30 mm, preferably 15 mm.
  • the length of the part of the puncture needle 2 located in the needle seat 4 may be set to 10 mm to 20 mm, for example, 10 mm to 15 mm, or 15 mm to 20 mm, preferably 14 mm.
  • the total length of the puncture needle 2 is or about 35mm
  • the extension length from the needle hub 4 is or about 6mm
  • the extension length from the needle hub 4 inward is or about It is 15 mm
  • the length of the part located in the needle hub 4 is or approximately 14 mm.
  • the bevel angle of the needle tip of the puncture needle 2 can be set to 5° to 50°, for example, it can be set to 8°, 10°, 12°, 15°, 17°, 19°, 43°, 45°, 47°, etc.
  • the volume of the aqueous humor collected by the puncture needle 2 can be 10 ⁇ L to 100 ⁇ L, for example, can be set to 32 ⁇ L, 37.5 ⁇ L, 40 ⁇ L, 45 ⁇ L, 48 ⁇ L, 50 ⁇ L, 51 ⁇ L, 55 ⁇ L, 60 ⁇ L, 62.5 ⁇ L, 69 ⁇ L, etc. .
  • the target volume of the aqueous humor collected by the puncture needle 2 may be 10 ⁇ L to 100 ⁇ L, for example, it may be set to 32 ⁇ L, 37.5 ⁇ L, 40 ⁇ L, 45 ⁇ L, 48 ⁇ L, 50 ⁇ L, 51 ⁇ L, 55 ⁇ L, 60 ⁇ L, 62.5 ⁇ L, 69 ⁇ L. Wait.
  • the use of the aqueous humor collection device and method of the present invention contributes to the accuracy of aqueous humor collection.
  • the volume of the collected aqueous humor can reach the target volume ⁇ 1%, the target volume ⁇ 5%, and the target volume Volume ⁇ 10%, target volume ⁇ 15%, target volume ⁇ 20%, or target volume ⁇ 25%.
  • the shape of the liquid collection tube 31 is compatible with a centrifuge, and the maximum centrifugal force it can bear is 4000 g n .
  • the volume of the liquid collection tube 31 provided with the tube plug 33 (that is, the negative pressure liquid collection tube 31) can be set to 8 ⁇ L to 310 ⁇ L (for example, it can be set to 10 ⁇ L, 50 ⁇ L, 100 ⁇ L, 150 ⁇ L, 200 ⁇ L, 250 ⁇ L , 300 ⁇ L, etc.), the air pressure range can be set from 1*103Pa to 1*104Pa.
  • the air pressure range in the liquid collection tube 31 provided with the tube plug 33 is set to be between 8mmHg and 40mmHg, such as 8mmHg to 10mmHg, 10mmHg to 15mmHg, 15mmHg to 20mmHg, 20mmHg to 25mmHg, 25mmHg to 30mmHg, 30mmHg to 35mmHg, or 35mmHg to 40mmHg.
  • the inner diameter of the liquid collection tube 31 can be set to 2.5 mm to 6 mm, the outer diameter can be set to 3 mm to 8 mm, and the tube length can be set to 20 mm to 30 mm.
  • the outer diameter of the outer cylinder body 1 can be set to 6 mm to 16 mm
  • the length of the support tube frame 32 can be set to 20 mm to 50 mm
  • the diameter of the support tube frame 32 can be set to 5 mm to 20 mm when it is a circular tube frame.
  • the outer cylinder body 1 can be made of 304 stainless steel
  • the needle holder 4, the support tube frame 32 and the soft cover 8 can all be made of PP material
  • the liquid collection tube 31 can be made of PET material
  • the position member 37 can be made of rubber.
  • the total length of the puncture needle 2 is or is about 35mm, the extension length from the needle hub 4 is or about 6mm, and the extension length from the needle hub 4 is or
  • the length of the part located in the needle seat 4 is about 15mm or about 14mm;
  • the outer diameter of the puncture needle 2 is set to 0.5mm (25G);
  • the bevel angle of the needle tip of the puncture needle 2 is set to 17° ⁇ 2°;
  • the volume of the liquid sampling tube 31 of the tube plug 33 is set to be 8 ⁇ L to 310 ⁇ L, and the air pressure range in the liquid sampling tube is set to be between 8 mmHg and 40 mmHg.
  • the present invention provides a method of collecting aqueous humor from the cornea, including:
  • the step of pushing the rear end of the liquid collection tube assembly 3 may include:
  • the aqueous humor in the anterior chamber passes through the puncture needle 2 under the pressure difference between the intraocular pressure and the negative pressure in the collection tube 31 and flows into the collection tube 31 for about 1 s, 2 s, 3 s. , 4s, 5s, 6s, 7s, 8s, 9s, 10s, 11s, 12s, 13s, 14s, 15s, 16s, 17s, 18s, 19s, 20s, 21s, 22s, 23s, 24s, 25s, 26s, 27s, 28s , 29s, 30s or longer.
  • the step of taking out the sampling tube assembly 3 from the outer cylinder 1 may include: not applying external force to the sampling tube assembly, or stopping or reducing the external force applied to the sampling tube assembly, allowing the sampling tube assembly to rebound.
  • the liquid sampling tube assembly 3 can be ejected naturally without applying external force to specifically pull out the liquid sampling tube assembly.
  • the present invention provides a method for collecting aqueous humor from the eyes of a subject, including:
  • the step of pushing the rear end of the liquid collection tube assembly 3 may include:
  • the aqueous humor in the anterior chamber passes through the puncture needle 2 under the pressure difference between the intraocular pressure and the negative pressure in the collection tube 31 and flows into the collection tube 31 for about 1 s, 2 s, 3 s. , 4s, 5s, 6s, 7s, 8s, 9s, 10s, 11s, 12s, 13s, 14s, 15s, 16s, 17s, 18s, 19s, 20s, 21s, 22s, 23s, 24s, 25s, 26s, 27s, 28s , 29s, 30s or longer.
  • the step of taking out the sampling tube assembly 3 from the outer cylinder 1 may include: not applying external force to the sampling tube assembly, or stopping or reducing the external force applied to the sampling tube assembly, allowing the sampling tube assembly to rebound.
  • the liquid sampling tube assembly 3 can be ejected naturally without applying external force to specifically pull out the liquid sampling tube assembly.
  • the present invention provides a method for collecting aqueous humor from the eyes of a subject, including:
  • the aqueous humor in the anterior chamber of the eye passes through the puncture needle 2 and flows into the liquid collection tube 31 under the pressure difference between the intraocular pressure and the negative pressure.
  • This step can continue or last for about 1s, 2s, 3s, 4s, 5s, 6s, 7s, 8s, 9s, 10s, 11s, 12s, 13s, 14s, 15s, 16s, 17s, 18s, 19s, 20s, 21s, 22s, 23s, 24s, 25s, 26s, 27s, 28s, 29s or 30s;
  • the method may further include selecting the negative pressure inside the liquid collection tube 31, which is lower than the intraocular pressure of the subject's eye.
  • the intraocular pressure of the subject is between 7mmHg and 50mmHg, for example, 7mmHg to 10mmHg, 10mmHg to 20mmHg, 20mmHg to 30mmHg, 30mmHg to 40mmHg or 40mmHg to 50mmHg.
  • the air pressure range in the liquid collection tube 31 provided with the tube plug 33 can be set between 8mmHg and 40mmHg, for example, 8mmHg to 10mmHg, 10mmHg to 15mmHg, 15mmHg to 20mmHg, 20mmHg To 25mmHg, 25mmHg to 30mmHg, 30mmHg to 35mmHg or 35mmHg to 40mmHg.
  • the air pressure range in the liquid collection tube 31 provided with the tube plug 33 is about 0.5mmHg, 1mmHg, 2mmHg, 3mmHg, 4mmHg, 5mmHg, 6mmHg lower than the intraocular pressure of the subject. , 7mmHg, 8mmHg, 9mmHg or 10mmHg.
  • the present invention provides a method of assembling the aforementioned aqueous humor collection device.
  • the assembling method includes assembling the pipe plug 33 and the liquid sampling tube 31 in a negative pressure box to set a negative pressure in the lumen of the liquid sampling tube.
  • the negative pressure in the negative pressure box can be adjusted to assemble liquid collection tubes with different negative pressure values.
  • the above-mentioned aqueous humor collection device can be provided with different models, corresponding to different negative pressure values of the liquid collection tube. According to the subject's intraocular pressure, a suitable negative pressure value of the fluid collection tube can be selected to collect aqueous humor safely and reliably.
  • the rabbits were randomly divided into the first group and the second group at a ratio of 1:1, with 10 rabbits in each group.
  • the anterior aqueous humor of the right eye was collected with an aqueous humor collection device, and the anterior aqueous humor of the left eye was collected with a 1 ml syringe, and the puncture was performed with the right hand.
  • the anterior aqueous humor of the left eye was collected with an aqueous humor collection device, and the anterior aqueous humor of the right eye was collected with a 1 ml syringe, and the left hand was used for puncture operation.
  • the rabbits were anesthetized by intramuscular injection of xylazine hydrochloride injection (Lu Mianning) and placed on their side during the puncture. Local anesthesia was performed 5 minutes before the operation, and Obucaine Hydrochloride Eye Drops (Benoxi) were applied once to both eyes.
  • the rabbit is placed in a lateral position, and the needle is inserted from the cornea about 1mm to 2mm away from the limbus, keeping the needle parallel to the plane of the iris, and avoiding the anterior lens capsule.
  • the aqueous humor collection device uses one hand to perform anterior chamber puncture and anterior aqueous humor collection according to the above-mentioned aqueous humor collection method.
  • a 1ml syringe is used to hold the puncture with one hand and enter the anterior chamber, and then slowly pull the needle with the other hand to gradually draw the aqueous humor into the syringe, and then transfer the aqueous humor to the microcentrifuge tube.
  • the target extraction volume of the 1ml syringe group and the aqueous humor collection device group is set to be the same, and both are set to 50ul.
  • a stopwatch was used to record the time from the beginning of the puncture to the completion of the entire operation of the anterior aqueous humor collection.
  • the methods for measuring and calculating the volume of anterior aqueous humor in each group are as follows:
  • the puncture operation uses a precision balance to weigh the net weight m1 (mg) of the collection tube 31 (internal part of the aqueous humor collection device) or microcentrifuge tube (corresponding to the method of extracting aqueous humor from a 1ml syringe), and measure the anterior chamber after the puncture
  • the weight of the water collection tube 31 or the microcentrifuge tube is m2 (mg)
  • the anterior chamber was evaluated under a slit lamp, and the Seidel test was used to detect the leakage of aqueous humor at the puncture site. After 7 days, the anterior segment was checked again with a slit lamp.
  • CR group aqueous humor collection device-right-hand operation group
  • CL group aqueous humor collection device-left-hand operation group
  • SR group 1ml Syringe-right-hand operation group
  • SL group 1ml syringe-left-hand operation group.
  • CR or collector(R) represents aqueous humor collection device-right-hand operation group
  • CL or collector(L) represents aqueous humor collection device-left-hand operation group
  • SR or syringe(R) represents 1ml syringe-right-hand operation group
  • SL or Syringe (L) represents the 1ml syringe-left-hand operation group.
  • ADTV absolute value of deviation
  • the target collection volume (50ul) of the SR group and the SL group were 35.11 ⁇ 18.70ul (range 14.00 to 73.50) ul and 33.61 ⁇ 14.95 (range 13.20 to 65.80) ⁇ l respectively.
  • the ADTV of the two aqueous humor collection device subgroups was significantly lower than that of the two 1ml syringe subgroups (SR and SL group). However, there was no statistical difference between the two subgroups of the aqueous humor collection device and the two subgroups of the 1ml syringe (P>0.05).
  • CR or collector(R) represents aqueous humor collection device-right-hand operation group
  • CL or collector(L) represents aqueous humor collection device-left-hand operation group
  • SR or syringe(R) represents 1ml syringe-right-hand operation group
  • SL or Syringe (L) represents the 1ml syringe-left-hand operation group.
  • the operation time of the two subgroups using the aqueous humor collection device was shorter than that of the two subgroups using the 1ml syringe, and the difference was statistically significant (P ⁇ 0.01), but between the left and right hand operation subgroups There was no statistical difference (P>0.05).
  • anterior segment examination can show varying degrees of iris hyperemia and anterior chamber flashes, but they basically subside within one week after surgery (see Figure 31).
  • the Seidel test immediately after the puncture showed that the puncture ports of all the tested eyes were well closed, and there was no leakage of anterior aqueous humor (see Figure 31).
  • the rabbit undergoes an anterior segment examination immediately after the anterior chamber puncture, and the iris congestion (A, F) and anterior chamber flash (B, G) of both eyes can be found.
  • the Seidel test showed that there was no leakage of anterior aqueous humor from the puncture port (C, H). Iris hyperemia (D, I) and anterior chamber flash (E, J) disappeared completely one week after puncture. Note that the left eye of the rabbit is drawn with a 1ml syringe (A to E), and the right eye is drawn with the aqueous humor collection device (F to J).
  • the disposable anterior chamber puncture device ie the aqueous humor collection device of the present invention
  • the disposable anterior chamber puncture device used in this experiment has many substantial advantages.
  • the complete anterior chamber puncture and anterior chamber water sampling process can be easily completed with a series of simple operations with one hand.
  • the accurate sampling of anterior aqueous humor was achieved for the first time.
  • the operator does not need to pay attention to the volume of the collected specimen during the sampling process, nor does it need to concentrate on finely controlling the pressure applied to the pipette or the force of pulling the needle, but can focus all attention on the eye being operated. on.
  • the other hand can help stabilize the patient's head or help fix the eyeball during the operation.
  • the fifth advantage is that there is no need to transfer the specimen after the anterior aqueous humor is collected, because the liquid collection tube 31 of the aqueous humor collection device is itself a microcentrifuge tube. This function also helps to avoid loss of specimens during the transfer process, improves operation efficiency, and avoids specimen contamination.
  • this animal experiment confirms that the new disposable anterior chamber puncture device achieves one-handed operation and accurate and quantitative collection of anterior aqueous humor. Compared with traditional anterior aqueous sampling methods using syringes, it has higher safety and accuracy. .
  • an aqueous humor collection device including:
  • the outer cylinder is provided with a puncture needle installation end and a liquid sampling tube installation end at both axial ends;
  • the puncture needle is fixedly installed at the puncture needle installation end and is provided with an inner end of the puncture needle located in the cavity of the outer cylinder and an outer end of the puncture needle located outside the cavity of the outer cylinder;
  • the liquid sampling tube assembly includes a liquid sampling tube that is inserted from the installation end of the liquid sampling tube into the barrel cavity of the outer cylinder and can be inserted and removed in the axial direction, and is arranged in the outer cylinder cavity for sealing the nozzle of the liquid sampling tube Silencer;
  • the static friction coefficient between the pipe plug and the inner peripheral wall of the outer cylinder is ⁇ 1
  • the static friction coefficient between the pipe plug and the nozzle of the liquid collection tube is ⁇ 2, and satisfies: ⁇ 1 ⁇ 2;
  • the pipe plug is arranged at intervals on the inner peripheral wall of the outer cylinder.
  • smooth contact is formed between the pipe plug and the inner peripheral wall of the outer cylinder.
  • the aqueous humor collection device further includes an anti-sloshing structure for limiting the displacement of the liquid sampling tube assembly along the radial direction of the outer cylinder cavity.
  • the anti-sloshing structure includes an annular groove formed on the outer peripheral wall of the liquid sampling tube assembly and an annular stopper provided in the annular groove of the hoop. The radially outer end of the annular stopper abuts the outer cylinder Peripheral wall of the body.
  • the annular stopper is a rubber band.
  • the groove side wall of the annular groove is formed with groove vent holes penetrating along the axial direction of the outer cylinder cavity, and the outer cylinder cavity is between the pipe plug and the puncture needle mounting end. The area is connected to the groove vent.
  • the aqueous humor collection device further includes a needle holder for fixedly installing the puncture needle, and a quick plug connection is formed between the inner end of the needle holder and the installation end of the puncture needle.
  • a threaded connection or a snap connection is formed between the inner end of the needle base and the puncture needle installation end.
  • the aqueous humor collection device further includes an anti-puncture spacer for isolating the inner end of the puncture needle and the tube plug along the axial direction of the outer cylinder cavity, and the anti-puncture spacer is a detachable component.
  • the peripheral wall of the outer cylinder is provided with a spacer insertion groove, and the outer cylinder cavity is connected to the spacer insertion groove at the area between the inner end of the puncture needle and the pipe plug, and the anti-puncture spacer passes The spacer insertion slot is inserted into the barrel cavity area.
  • an aqueous humor collection device including:
  • the outer cylinder including the puncture needle installation end and the liquid collection tube installation end;
  • the puncture needle is fixedly installed at the installation end of the puncture needle, and the puncture needle includes an inner end of the puncture needle and an outer end of the puncture needle respectively protruding from both axial sides of the installation end of the puncture needle;
  • the liquid sampling tube assembly includes a liquid sampling tube that is inserted from the installation end of the liquid sampling tube into the barrel cavity of the outer cylinder and can be inserted and removed in the axial direction, and is arranged in the outer cylinder cavity for sealing the nozzle of the liquid sampling tube Silencer;
  • the pipe plug is coaxially arranged with the cavity of the outer cylinder, and the radius of the pipe plug is smaller than the radius of the inner peripheral wall of the outer cylinder, and the outer peripheral wall of the liquid sampling tube assembly is provided with an annular groove and an annular stopper provided by the ring groove , The radially outer end of the annular limiter abuts against the inner peripheral wall of the outer cylinder.
  • the radial distance between the radially outer end of the pipe plug and the inner circumferential wall of the outer cylinder is not less than 1 mm.
  • the liquid sampling tube assembly includes a supporting tube rack, the liquid sampling tube is inserted into the inner cavity of the supporting tube rack, and the annular groove is provided on the outer peripheral wall of the supporting tube rack.
  • a threaded connection or a snap connection is formed between the liquid sampling tube and the supporting tube frame.
  • the groove side wall of the annular groove is formed with a groove vent hole penetrating along the axial direction of the outer cylinder cavity, and the outer cylinder cavity is between the pipe plug and the puncture needle mounting end.
  • the cavity area communicates with the groove vent.
  • the annular limiting member is an elastic member.
  • the aqueous humor collection device further includes a needle holder for fixedly installing the puncture needle, and a quick plug-in connection is formed between the inner end of the needle holder and the installation end of the puncture needle.
  • a threaded connection or a snap connection is formed between the inner end of the needle base and the puncture needle installation end.
  • the aqueous humor collection device further includes an anti-puncture spacer for isolating the inner end of the puncture needle and the tube plug along the axial direction of the outer cylinder cavity, and the anti-puncture spacer is a detachable component.
  • the peripheral wall of the outer cylinder is provided with a spacer inserting groove, and the outer cylinder cavity is connected to the spacer inserting groove at the area between the inner end of the puncture needle and the pipe plug to prevent puncture and isolation.
  • the part is inserted into the barrel cavity area through the spacer insertion slot.
  • an aqueous humor collection device including:
  • the outer cylinder including the puncture needle installation end and the liquid collection tube installation end;
  • the puncture needle is fixedly installed at the puncture needle installation end and is provided with an inner end of the puncture needle located in the cavity of the outer cylinder and an outer end of the puncture needle located outside the cavity of the outer cylinder;
  • the liquid sampling tube assembly includes a liquid sampling tube that is inserted from the installation end of the liquid sampling tube into the barrel cavity of the outer cylinder and can be inserted and removed in the axial direction, and is arranged in the outer cylinder cavity for sealing the nozzle of the liquid sampling tube Silencer;
  • the outer peripheral wall of the liquid sampling tube assembly is provided with an annular groove and an annular stopper provided by the ring-shaped annular groove, the radial outer end of the annular stopper abuts against the inner peripheral wall of the outer cylinder, and the radial outer edge of the pipe plug Smooth contact is formed between the inner peripheral wall of the outer cylinder and the outer cylinder, and there is a pipe plug exhaust channel arranged along the extension direction of the outer cylinder cavity.
  • the outer cylinder cavity is in the area of the cavity between the pipe plug and the puncture needle mounting end Connect the exhaust passage of the pipe plug.
  • the pipe plug is provided with a plurality of pipe plug exhaust passages that extend along the axial direction of the outer cylinder cavity and are sequentially spaced in the circumferential direction of the pipe plug.
  • a pipe plug exhaust groove serving as a pipe plug exhaust passage is formed on the outer peripheral wall of the pipe plug, and the pipe plug exhaust groove is provided with a groove opening facing radially outward.
  • the channel peripheral wall of the pipe plug exhaust channel is a closed peripheral wall.
  • the cross section of the exhaust passage of the pipe plug is in a semicircular shape, a square shape or an arc shape.
  • the pipe plug includes a central part of the pipe plug for sealing the nozzle of the liquid collection pipe and an outer ring part of the pipe plug located radially outside the central part of the pipe plug and provided with an exhaust passage of the pipe plug.
  • the outer ring portion is at least partially formed as a loose ventilation structure.
  • the end of the tube plug is provided with a puncture guide hole for guiding the inner end of the puncture needle to penetrate, and the outer contour shape of the inner end of the puncture needle matches the shape of the puncture guide hole.
  • a peripheral wall exhaust gap is provided between the liquid sampling tube and the inner peripheral wall of the outer cylinder, and the outer cylinder cavity is in the area of the cylinder cavity between the pipe plug and the puncture needle installation end, the pipe plug exhaust channel and The peripheral wall exhaust gaps are connected in sequence.
  • the outer peripheral wall of the inner end of the puncture needle is provided with a peripheral wall water outlet hole communicating with the needle cavity of the puncture needle.
  • the inner end of the puncture needle is further provided with an axial water outlet hole communicating with the needle cavity in the axial direction, and the axial distance between the hole center of the peripheral wall water outlet hole and the hole center of the axial water outlet hole is not more than 3 mm.
  • an aqueous humor collection device including:
  • the outer cylinder including the puncture needle installation end and the liquid collection tube installation end;
  • the puncture needle is fixedly installed at the puncture needle installation end and is provided with an inner end of the puncture needle located in the cavity of the outer cylinder and an outer end of the puncture needle located outside the cavity of the outer cylinder;
  • the sampling tube is inserted into the cavity of the outer cylinder from the installation end of the sampling tube and can be inserted and removed in the axial direction;
  • the pipe plug is arranged in the barrel cavity of the outer cylinder and is used to seal the nozzle of the liquid sampling tube.
  • the radial outer edge of the pipe plug is provided with a pipe plug exhaust passage arranged along the extension direction of the outer barrel cavity.
  • the exhaust channel communicates with the barrel cavity area of the outer barrel cavity between the pipe plug and the puncture needle installation end.
  • the pipe plug is provided with a plurality of pipe plug exhaust passages that extend along the axial direction of the outer cylinder cavity and are sequentially spaced in the circumferential direction of the pipe plug.
  • a pipe plug exhaust groove serving as a pipe plug exhaust passage is formed on the outer peripheral wall of the pipe plug, and the pipe plug exhaust groove is provided with a groove opening facing radially outward.
  • the channel peripheral wall of the pipe plug exhaust channel is a closed peripheral wall.
  • the cross section of the exhaust passage of the pipe plug is in a semicircular shape, a square shape or an arc shape.
  • the pipe plug includes a central part of the pipe plug for sealing the nozzle of the liquid collection pipe and an outer ring part of the pipe plug located radially outside the central part of the pipe plug and provided with an exhaust passage of the pipe plug.
  • the outer ring portion is at least partially formed as a loose ventilation structure.
  • the end of the tube plug is provided with a puncture guide hole for guiding the inner end of the puncture needle to penetrate, and the outer contour shape of the inner end of the puncture needle matches the shape of the puncture guide hole.
  • a peripheral wall exhaust gap is provided between the liquid sampling tube and the inner peripheral wall of the outer cylinder, and the outer cylinder cavity is in the area of the cylinder cavity between the pipe plug and the puncture needle installation end, the pipe plug exhaust channel and The peripheral wall exhaust gaps are connected in sequence.
  • an aqueous humor collection device which includes an outer cylinder, a puncture needle, and a collection tube assembly.
  • the outer cylinder is provided with a puncture needle installation end and a collection tube installation end.
  • the puncture needle is inserted in the puncture
  • the needle mounting end includes the outer end of the puncture needle and the inner end of the puncture needle inserted into the barrel cavity of the outer cylinder.
  • the liquid sampling tube assembly is inserted into the cavity of the outer cylinder from the liquid sampling tube installation end and includes pluggable movement
  • the liquid sampling tube and the plug for sealing the nozzle of the liquid sampling tube in the outer cylinder cavity; wherein the aqueous humor collection device also includes a device for limiting the displacement of the liquid sampling tube assembly along the radial direction of the outer cylinder cavity Anti-shake structure.
  • the liquid sampling tube assembly further includes a support tube rack, the liquid sampling tube is inserted into the inner cavity of the tube rack of the support tube rack, and the anti-sloshing structure includes from the outer peripheral wall of the support tube rack or from the inner peripheral wall of the outer cylinder A protruding limiting protrusion, the radial two ends of the limiting protrusion are respectively connected to the outer peripheral wall of the support pipe frame and the inner peripheral wall of the outer cylinder.
  • liquid sampling tube and the supporting tube frame are fixed by screw connection or snap connection.
  • the limiting protrusion is integrally formed on the outer peripheral wall of the support tube rack; or, the liquid sampling tube assembly includes a tube set sheathed on the outer peripheral wall of the support tube rack, and the limiting protrusion is provided on the tube set On the peripheral wall.
  • the tube set is an elastic tube set.
  • the anti-sloshing structure includes a plurality of limiting protrusions arranged at intervals along the circumferential direction;
  • the anti-sloshing structure includes a limiting protrusion formed continuously extending in the circumferential direction, and an exhaust gap is formed between the limiting protrusion and the outer peripheral wall of the supporting pipe frame or between the limiting protrusion and the inner peripheral wall of the outer cylinder.
  • the plurality of limiting protrusions arranged at intervals along the circumferential direction are all convex points.
  • the limiting protrusion formed continuously extending in the circumferential direction is corrugated or obliquely toothed.
  • an aqueous humor collection device including:
  • the outer cylinder is provided with a puncture needle installation end and a liquid collection tube installation end;
  • the puncture needle is inserted into the installation end of the puncture needle and includes the outer end of the puncture needle and the inner end of the puncture needle extending into the cavity of the outer cylinder;
  • the liquid sampling tube assembly is pluggable and movably inserted from the installation end of the liquid sampling tube into the barrel cavity of the outer cylinder and includes a liquid sampling tube and a plug for sealing the nozzle of the liquid sampling tube in the cavity of the outer cylinder;
  • a ventilation structure is formed between the liquid sampling tube assembly and the inner peripheral wall of the outer cylinder, and the ventilation structure communicates with the cylinder cavity area of the outer cylinder cavity between the inner end of the puncture needle and the plug.
  • the aqueous humor collection device also includes The limiting liquid sampling tube assembly is displaced in the radial direction and is used to form a contact damping limiting buffer structure between the liquid sampling tube assembly and the inner peripheral wall of the outer cylinder.
  • the limiting buffer structure includes a limiting protrusion protruding from the outer peripheral wall of the sampling tube assembly or from the inner peripheral wall of the outer cylinder, and the radial ends of the limiting protrusion are respectively connected to the sampling tube assembly The outer peripheral wall and the inner peripheral wall of the outer cylinder.
  • the limiting buffer structure includes limiting protrusions arranged at intervals along the tube length direction of the liquid sampling tube assembly or continuously extending along the tube length direction, and the total span of the limiting protrusions along the tube length direction is not less than Half the length of the liquid sampling tube.
  • the limiting protrusion is integrally formed on the outer peripheral wall of the liquid sampling tube; or, the liquid sampling tube assembly includes a tube set sheathed on the outer peripheral wall of the liquid sampling tube, and the limiting protrusion is provided on the tube set On the peripheral wall.
  • the tube set is an elastic tube set.
  • the limiting buffer structure includes a plurality of limiting protrusions arranged at intervals along the circumferential direction, and the gap between the plurality of limiting protrusions is formed as a venting structure;
  • the limit buffer structure includes a limit protrusion formed continuously extending in the circumferential direction, and a ventilation structure is formed between the limit protrusion and the outer peripheral wall of the liquid sampling tube assembly or between the limit protrusion and the inner peripheral wall of the outer cylinder Exhaust gap.
  • the plurality of limiting protrusions arranged at intervals along the circumferential direction are all convex points.
  • the limiting protrusion formed continuously extending in the circumferential direction is corrugated or obliquely toothed.
  • the liquid sampling tube assembly further includes a supporting tube frame for fixing the liquid sampling tube, and a limited buffer structure is formed between the outer peripheral wall of the supporting tube frame and the inner peripheral wall of the outer cylinder.
  • liquid sampling tube and the supporting tube frame are fixed by screw connection or snap connection.
  • an aqueous humor collection device includes:
  • the outer cylinder is provided with a puncture needle installation end and a liquid sampling tube installation end at both axial ends;
  • the puncture needle is fixedly installed at the puncture needle installation end and is provided with an inner end of the puncture needle located in the cavity of the outer cylinder and an outer end of the puncture needle located outside the cavity of the outer cylinder;
  • the liquid sampling tube assembly includes a liquid sampling tube that is inserted from the installation end of the liquid sampling tube into the barrel cavity of the outer cylinder and can be inserted and removed in the axial direction, and is arranged in the outer cylinder cavity for sealing the nozzle of the liquid sampling tube Silencer;
  • the static friction coefficient between the pipe plug and the inner peripheral wall of the outer cylinder is ⁇ 1
  • the static friction coefficient between the pipe plug and the nozzle of the liquid collection tube is ⁇ 2, and satisfies: ⁇ 1 ⁇ 2;
  • the pipe plug is arranged at intervals on the inner peripheral wall of the outer cylinder.
  • smooth contact is formed between the pipe plug and the inner peripheral wall of the outer cylinder.
  • the aqueous humor collection device further includes an anti-sloshing structure for limiting the displacement of the liquid sampling tube assembly along the radial direction of the outer cylinder cavity.
  • the anti-sloshing structure includes an annular groove formed on the outer peripheral wall of the liquid sampling tube assembly and an annular stopper provided in the annular groove of the hoop. The radially outer end of the annular stopper abuts the outer The inner wall of the cylinder.
  • the groove side wall of the annular groove is formed with a groove vent hole penetrating along the axial direction of the outer cylinder cavity, and the outer cylinder cavity is between the pipe plug and the puncture needle mounting end.
  • the cavity area communicates with the groove vent.
  • the liquid sampling tube assembly includes a supporting tube rack, the liquid sampling tube is inserted into the inner cavity of the supporting tube rack, and the annular groove is provided on the outer peripheral wall of the supporting tube rack.
  • the liquid sampling tube assembly further includes a support tube rack, the liquid sampling tube is inserted into the inner cavity of the tube rack of the support tube rack, and the anti-sloshing structure includes from the outer peripheral wall of the support tube rack or from the inner peripheral wall of the outer cylinder A protruding limiting protrusion, the radial two ends of the limiting protrusion are respectively connected to the outer peripheral wall of the support pipe frame and the inner peripheral wall of the outer cylinder.
  • the aqueous humor collection device further includes a needle holder for fixedly installing the puncture needle, and a quick plug-in connection is formed between the inner end of the needle holder and the installation end of the puncture needle.
  • the aqueous humor collection device further includes an anti-puncture spacer for isolating the inner end of the puncture needle and the tube plug along the axial direction of the outer cylinder cavity, and the anti-puncture spacer is a detachable component.
  • the peripheral wall of the outer cylinder is provided with a spacer inserting groove, and the outer cylinder cavity is connected to the spacer inserting groove at the area between the inner end of the puncture needle and the pipe plug to prevent puncture and isolation.
  • the part is inserted into the barrel cavity area through the spacer insertion slot.
  • a method for collecting aqueous humor from the cornea including:
  • the method includes: pushing the rear end of the sampling tube assembly to move the sampling tube in the sampling tube assembly toward the inner end of the puncture needle, so that the inner end of the puncture needle enters through the plug
  • the collection tube includes:
  • a method for collecting aqueous humor from the eyes of a subject including:
  • the method includes: pushing the rear end of the sampling tube assembly to move the sampling tube in the sampling tube assembly toward the inner end of the puncture needle, so that the inner end of the puncture needle enters through the plug
  • the collection tube includes:
  • the method includes: selecting the negative pressure inside the liquid collection tube, which is lower than the intraocular pressure of the subject's eye.
  • a reagent holder which includes a holder body and a functional position provided on the holder body.
  • the functional position includes a liquid-containing tube insertion hole and an elastic member, and the elastic member is configured to: When the liquid receiving tube is inserted in the hole, it can elastically act on the liquid receiving tube, so that the liquid receiving tube can elastically move along the central axis of the liquid receiving tube insertion hole.
  • the functional position further includes a functional position outer sleeve, which protrudes downward from the inner peripheral wall of the insertion hole of the liquid receiving tube along the direction of the center axis of the hole, and the elastic component is located in the functional position outer sleeve The inner cavity of the sleeve.
  • the elastic component is a spring mechanism or an elastic medium.
  • the spring mechanism is located at the bottom of the sleeve cavity and can be elastically moved along the center axis of the hole. During the elastic movement of the spring mechanism, the outer periphery of the spring mechanism at least partially fits inside the sleeve cavity. Peripheral wall slippage.
  • the elastic component is located at the bottom of the inner cavity of the sleeve, and the top center of the elastic component is formed with a supporting recess for supporting the bottom of the liquid receiving tube.
  • the reagent holder is a strip holder.
  • the functional position includes a sample position, a reagent position, a photometric position, a reaction position, or a reserved position.
  • a detection device assembly which includes a detection device, a liquid containing tube, and a reagent holder according to any one of claims 1 to 7.
  • the liquid containing tube is detachably inserted into the liquid containing tube insert.
  • the detection equipment includes a liquid taking device, which is configured to extend into the lumen of the liquid receiving tube to take liquid.
  • the detection device is configured to stop when the liquid taking device is subjected to a rigid collision.
  • the functional position further includes a functional position outer sleeve, which extends downward from the inner peripheral wall of the insertion hole of the liquid receiving tube along the direction of the center axis of the hole, and the outer contour of the bottom of the liquid receiving tube is Inverted taper, the liquid containing tube passes through the liquid containing tube insertion hole to be inserted into the sleeve cavity of the outer sleeve of the functional position, and the top of the liquid containing tube is not higher than the opening of the liquid containing tube insertion hole.
  • the outer diameter of the nozzle is the same as the inner diameter of the sleeve cavity.
  • a detection equipment assembly including:
  • the reagent holder is provided with a holder body and a functional position arranged on the holder body, and the functional position includes a liquid-containing tube insertion hole and an elastic component;
  • the liquid receiving tube is detachably inserted into the liquid receiving tube insertion hole, and the liquid receiving tube can be elastically moved along the central axis of the liquid receiving tube insertion hole by the elastic action of the elastic member;
  • the detection device is provided with a liquid taking needle for drawing liquid in the lumen of the liquid receiving tube, the outer end surface of the liquid taking needle is formed as an inclined end surface and a liquid taking port is formed on the inclined end surface.
  • the liquid taking needle extends along a straight line and includes a needle body section and a needle section that are connected to each other.
  • the outer end of the needle section is formed with a liquid taking port.
  • the center axis of the needle body section of the needle body section and the liquid taking port of the liquid taking port The central axis intersects.
  • the acute angle formed by the intersection of the central axis of the needle body section and the central axis of the liquid intake is ⁇ , and ⁇ satisfies: 0 ⁇ 0.1°.
  • the inclined end surface is a curved surface or a flat surface.
  • the inner bottom wall of the lumen of the liquid receiving tube is a flat wall or a curved wall.
  • the detection device is configured to stop when the liquid-taking needle is subjected to a rigid collision.
  • the functional position further includes a functional position outer sleeve, which protrudes downward from the inner peripheral wall of the insertion hole of the liquid receiving tube along the direction of the center axis of the hole, and the elastic component is located in the functional position outer sleeve The inner cavity of the sleeve.
  • the elastic component is a spring mechanism or an elastic medium.
  • the elastic component is located at the bottom of the inner cavity of the sleeve, and the top center of the elastic component is formed with a supporting recess for supporting the bottom of the liquid receiving tube.
  • the shape of the bit matches the outer contour of the bottom of the liquid pipe.
  • the functional positions are sample positions, reagent positions, photometric positions, reaction positions or reserved positions.
  • a reagent holder which includes a holder body and a functional position provided on the holder body.
  • the functional position includes a liquid-containing tube insertion hole and an elastic member, and the elastic member is configured to: When the liquid receiving tube is inserted in the hole, it can elastically act on the liquid receiving tube, so that the liquid receiving tube can elastically move along the central axis of the liquid receiving tube insertion hole.
  • the functional position further includes a functional position outer sleeve, which protrudes downward from the inner peripheral wall of the insertion hole of the liquid receiving tube along the direction of the center axis of the hole, and the elastic component is located in the functional position outer sleeve The inner cavity of the sleeve.
  • the elastic component is a spring mechanism or an elastic medium.
  • the spring mechanism is located at the bottom of the sleeve cavity and can be elastically moved along the center axis of the hole. During the elastic movement of the spring mechanism, the outer periphery of the spring mechanism at least partially fits inside the sleeve cavity. Peripheral wall slippage.
  • the reagent holder further includes a conversion socket detachably inserted into the insertion hole of the liquid containing tube, and the conversion socket includes a support sleeve portion and an extension sleeve portion connected up and down, and a sleeve supporting the sleeve portion
  • the cylinder cavity and the sleeve cavity of the extension sleeve part are connected up and down and jointly formed as a conversion insertion cavity, which is used for detachably inserting the liquid containing tube.
  • the functional position includes a sample position, a reagent position, a photometric position, a reaction position, or a reserved position.
  • a detection device assembly which includes a detection device, a liquid containing tube, and the above reagent holder.
  • the liquid containing tube is detachably inserted into the insertion hole of the liquid containing tube, and the detection device includes liquid taking The device, the liquid taking device is configured to extend into the lumen of the liquid receiving tube to take liquid.
  • the detection device is configured to stop when the liquid taking device is subjected to a rigid collision.
  • the functional position further includes a functional position outer sleeve, which extends downward from the inner peripheral wall of the insertion hole of the liquid receiving tube along the direction of the center axis of the hole, and the outer contour of the bottom of the liquid receiving tube is Inverted taper, the liquid containing tube passes through the liquid containing tube insertion hole to be inserted into the sleeve cavity of the outer sleeve of the functional position, and the top of the liquid containing tube is not higher than the opening of the liquid containing tube insertion hole.
  • the outer diameter of the nozzle is the same as the inner diameter of the sleeve cavity.
  • the liquid taking device is provided with a liquid taking needle extending into the lumen of the liquid receiving tube to take liquid.
  • the outer end surface of the liquid taking needle is formed as an inclined end surface and the liquid taking port is formed on the inclined end surface.
  • an aqueous humor collection device including:
  • the outer cylinder is provided with a puncture needle installation end and a liquid sampling tube installation end at both axial ends;
  • the puncture needle is fixedly installed at the puncture needle installation end and is provided with an inner end of the puncture needle located in the cavity of the outer cylinder and an outer end of the puncture needle located outside the cavity of the outer cylinder;
  • the liquid sampling tube assembly includes a liquid sampling tube that is inserted from the installation end of the liquid sampling tube into the barrel cavity of the outer cylinder and can be inserted and removed in the axial direction, and is arranged in the outer cylinder cavity for sealing the nozzle of the liquid sampling tube Silencer;
  • the static friction coefficient between the pipe plug and the inner peripheral wall of the outer cylinder is ⁇ 1
  • the static friction coefficient between the pipe plug and the nozzle of the liquid collection tube is ⁇ 2, and satisfies: ⁇ 1 ⁇ 2;
  • the pipe plug is arranged at intervals on the inner peripheral wall of the outer cylinder.
  • smooth contact is formed between the pipe plug and the inner peripheral wall of the outer cylinder.
  • the aqueous humor collection device further includes an anti-sloshing structure for limiting the displacement of the liquid sampling tube assembly along the radial direction of the outer cylinder cavity.
  • the anti-sloshing structure includes an annular groove formed on the outer peripheral wall of the liquid sampling tube assembly and an annular stopper provided in the annular groove of the hoop. The radially outer end of the annular stopper abuts the outer The inner wall of the cylinder.
  • the groove side wall of the annular groove is formed with a groove vent hole penetrating along the axial direction of the outer cylinder cavity, and the outer cylinder cavity is between the pipe plug and the puncture needle mounting end.
  • the cavity area communicates with the groove vent.
  • the liquid sampling tube assembly includes a supporting tube rack, the liquid sampling tube is inserted into the inner cavity of the supporting tube rack, and the annular groove is provided on the outer peripheral wall of the supporting tube rack.
  • the liquid sampling tube assembly further includes a support tube rack, the liquid sampling tube is inserted into the inner cavity of the tube rack of the support tube rack, and the anti-sloshing structure includes from the outer peripheral wall of the support tube rack or from the inner peripheral wall of the outer cylinder A protruding limiting protrusion, the radial two ends of the limiting protrusion are respectively connected to the outer peripheral wall of the support pipe frame and the inner peripheral wall of the outer cylinder.
  • the aqueous humor collection device further includes a needle holder for fixedly installing the puncture needle, and a quick plug-in connection is formed between the inner end of the needle holder and the installation end of the puncture needle.
  • the aqueous humor collection device further includes an anti-puncture spacer for isolating the inner end of the puncture needle and the tube plug along the axial direction of the outer cylinder cavity, and the anti-puncture spacer is a detachable component.
  • the peripheral wall of the outer cylinder is provided with a spacer inserting groove, and the outer cylinder cavity is connected to the spacer inserting groove at the area between the inner end of the puncture needle and the pipe plug to prevent puncture and isolation.
  • the part is inserted into the barrel cavity area through the spacer insertion slot.
  • a method for collecting aqueous humor from the cornea including:
  • the method includes: pushing the rear end of the sampling tube assembly to move the sampling tube in the sampling tube assembly toward the inner end of the puncture needle, so that the inner end of the puncture needle enters through the plug
  • the collection tube includes:
  • a method for collecting aqueous humor from the eyes of a subject including:
  • the method includes: pushing the rear end of the sampling tube assembly to move the sampling tube in the sampling tube assembly toward the inner end of the puncture needle, so that the inner end of the puncture needle enters through the plug
  • the collection tube includes:
  • the method includes: selecting the negative pressure inside the liquid collection tube, which is lower than the intraocular pressure of the subject's eye.

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Abstract

一种试剂支架、检测设备总成、房水采集装置和房水采集方法,试剂支架(9)包括支架本体和设置在支架本体上的功能位,功能位包括盛液管插装孔(91)和弹性部件,弹性部件在盛液管插装孔(91)内插装有盛液管(106)的情况下,能够弹性作用于盛液管(106),以使得盛液管(106)能够沿盛液管插装孔(91)的孔中心轴线方向弹性移动。通过利用试剂支架弹性固定盛液管(106),能够将取液装置与盛液管(106)的底壁的刚性碰撞转化为弹性碰撞,避免检测设备在取液过程中被触发撞针保护功能,从而使取液装置可伸入盛液管(106)的管腔内的深度大大增加,进而有效增加样本提取量。

Description

试剂支架、检测设备总成、房水采集装置和房水采集方法 技术领域
本发明涉及医疗器具技术领域,具体地,例如涉及一种房水采集装置及方法,一种试剂支架和检测设备总成,以及房水采集以及检测联合的装置及方法。
背景技术
在目前的IVD(体外诊断产品)领域中,一些检测设备设有取液针以伸入样本容器的容腔中进行取样,为防止取液针碰撞损坏,检测设备通常设有撞针保护功能,即在针头刚性碰撞到样本容器的内壁时报错并停机。因此为保证取样过程的连贯性,需要限制针头的伸入深度以防止其触碰到样本容器底壁。然而,当样本容器所能容置的样本量较少时,若针头的伸入深度较浅,会导致实际能提取到的样本量过小。
发明内容
针对现有技术的上述缺陷或不足,本发明提供了一种试剂支架、检测设备总成、房水采集装置和房水采集方法,能够将取液装置与盛液管之间的刚性碰撞转化为弹性碰撞,避免在取液过程中触发撞针保护功能以有效增加样本提取量。
为实现上述目的,在一些实施例中,本发明提供了一种试剂支架,所述试剂支架包括支架本体和设置在所述支架本体上的功能位,所述功能位包括盛液管插装孔和弹性部件,所述弹性部件设置为:在所述盛液管插装孔内插装有盛液管的情况下,能够弹性作用于所述盛液管,以使得所述盛液管能够沿所述盛液管插装孔的孔中心轴线方向弹性移动。
可选地,所述功能位还包括功能位外套筒,所述功能位外套筒从所述盛液管插装孔的内周壁沿所述孔中心轴线方向向下伸出,所述弹性部件位于所述功能位外套筒的套筒内腔。
可选地,所述弹性部件为弹簧机构或弹性介质。
可选地,所述弹簧机构位于所述套筒内腔的底部且能够沿所述孔中心轴线方向弹性移动,在所述弹簧机构的弹性移动过程中,所述弹簧机构的外周部至少部分贴合所述套筒内腔的内周壁滑移。
可选地,所述试剂支架还包括可拆卸地插装于所述盛液管插装孔内的转换插座,所述转换插座包括上下连接的支撑套筒部和延伸套筒部,所述支撑套筒部的套筒腔与所述延伸套筒部的套筒腔上下连通且共同形成为转换插装腔,所述转换插装腔用于供盛液管可拆卸地插入。
可选地,所述功能位为样本位、试剂位、测光位、反应位或预留位。
此外,在一些实施例中,本发明提供了一种检测设备总成,所述检测设备总成包括检测设备、盛液管和上述的试剂支架,所述盛液管可拆卸地插装在所述盛液管插装孔内,所述检测设备包括取液装置,所述取液装置设置为用于伸入所述盛液管的管腔内取液。
可选地,所述检测设备设置为在所述取液装置受到刚性碰撞时制停。
可选地,所述功能位还包括功能位外套筒,所述功能位外套筒从所述盛液管插装孔的内周壁沿所述孔中心轴线方向向下伸出,所述盛液管的底部外轮廓呈倒锥形,所述盛液管穿过所述盛液管插装孔以插入至所述功能位外套筒的套筒内腔且所述盛液管的顶端不高于所述盛液管插装孔的孔口,所述盛液管的管口外径与所述套筒内腔的内径相同。
可选地,所述取液装置设有用于伸入所述盛液管的管腔内取液的取液针,所述取液针的外端面形成为倾斜端面且所述倾斜端面上形成有取液口。
在本发明中,当取液装置伸入盛液管的管腔内取液且触碰到其底壁时,盛液管由于受到试剂支架中的弹性部件的弹性作用,能够沿盛液管插装孔的孔中心轴线方向弹性移动,从而将取液装置与盛液管的底壁的刚性碰撞转化为弹性碰撞,在弹性碰撞情况下,检测设备不会触发撞针保护功能。换言之,在采用本发明的试剂支架弹性固定盛液管的情况下,取液装置伸入盛液管的管腔内的深度得以大大增加,从而可有效增加样本提取量。
在一些实施例中,本发明提供了一种检测设备总成,所述检测设备总成包括:
试剂支架,设有支架本体和设置在所述支架本体上的功能位,所述功能位包括盛液管插装孔和弹性部件;
盛液管,可拆卸地插装于所述盛液管插装孔内,所述盛液管能够受到所述弹性部件的弹性作用以沿所述盛液管插装孔的孔中心轴线方向弹性移动;
检测设备,设有用于伸入所述盛液管的管腔内取液的取液针,所述取液针的外端面形成为倾斜端面且所述倾斜端面上形成有取液口。
可选地,所述取液针沿直线延伸且包括相互连接的针身段和针头段,所述针头段的外端形成有所述取液口,所述针身段的针身段中心轴线与所述取液口的取液口中心轴线相交。
可选地,所述针身段中心轴线与所述取液口中心轴线相交形成的锐角夹角为α,且α满足:0<α≤0.1°。
可选地,所述倾斜端面为曲面或平面。
可选地,所述盛液管的管腔内底壁为平面壁或曲面壁。
可选地,所述检测设备设置为在所述取液针受到刚性碰撞时制停。
可选地,所述功能位还包括功能位外套筒,所述功能位外套筒从所述盛液管插装孔的内周壁沿所述孔中心轴线方向向下伸出,所述弹性部件位于所述功能位外套筒的套筒内腔。
可选地,所述弹性部件为弹簧机构或弹性介质。
可选地,所述弹性部件位于所述套筒内腔的底部,所述弹性部件的顶部中心形成有用于支撑所述盛液管的底部的支撑凹位,所述盛液管的底部外轮廓呈倒锥形,所述支撑凹位的形状匹配于所述盛液管的底部外轮廓。
可选地,所述功能位为样本位、试剂位、测光位、反应位或预留位。
在一些实施例中,通过上述技术方案,由于盛液管弹性固定在试剂支架中,因此在取液针伸入盛液管的管腔内取液且触碰到其底壁时,取液针与盛液管的底壁仅产生弹性碰撞,因此不会触发撞针保护功能。而由于取液针的外端面形成为倾斜端面且取液口设置在该倾斜端面上,即使取液针触碰到不同形状的盛液管的底壁,取液口也不会被密封而影响正常取液,有利于增加取液时的样本提取量,并能保证在取液过程中的顺畅取液。
在一些实施例中,本发明的试剂支架和检测设备总成可与房水采集装置及方法配合使用。眼球前房穿刺术是一种通过器械刺穿眼球角膜以使房水流出的医疗技术,在眼科临床科研工作中有重要的应用价值,主要应用于降低眼压、房水采集和其他治疗性前房放液。
就目前而言,前房穿刺术的实施并无统一的专用器械和耗材,在实际临床工作中多以1ml注射器针头作为前房穿刺针。但在采用该1ml注射器针头进行穿刺的过程中,房水的引流速度较难控制,当放液过快时,会引起眼压的快速下降,更严重时甚至会引起其他并发症。此外,由于在房水采集完毕后,要将注射器腔体内的房水进一步转移至微量离心管,因此在此过程中,会造成房水的浪费,以及存在由于房水在转移过程中与外界环境接触而受到污染的风险,从而导致检测结果存在偏差,可靠性较差。由此可见,现阶段亟需研发出一种能够解决在前房穿刺过程中存在的安全性和可靠性差等问题的新型采集装置。
针对现有技术的上述缺陷或不足,本发明提供了一种房水采集装置,能够在穿刺过程中控制房水的引流速度,并能够避免房水在采集完毕后受到污染以及由于转移而造成浪费,从而提高安全性和可靠性。
为实现上述目的,在一些实施例中,本发明提供了一种房水采集装置,所述房水采集装置包括:
外筒体,设有位于轴向两端的穿刺针安装端和采液管安装端;
穿刺针,固定安装于所述穿刺针安装端且设有位于外筒体筒腔内的穿刺针内端和位于所述外筒体筒腔外的穿刺针外端;
采液管组件,包括从所述采液管安装端插入至所述外筒体筒腔内且能够沿轴向插拔移动的采液管和设置在所述外筒体筒腔内以用于密封采液管管口的管塞;
其中,所述管塞与外筒体内周壁之间的静摩擦系数为μ1,所述管塞与所述采液管管口之间的静摩擦系数为μ2,且满足:μ1<μ2;
或者,所述管塞间隔于外筒体内周壁设置。
可选地,所述环形限位件为弹性件。
可选地,所述管塞与所述外筒体内周壁之间形成光滑接触。
可选地,所述房水采集装置还包括用于限位所述采液管组件沿所述外筒体筒腔径向位移的防晃动结构。
可选地,所述防晃动结构包括形成在所述采液管组件的外周壁上的环形凹槽和环箍所述环形凹槽设置的环形限位件,所述环形限位件的径向外端抵接所述外筒体内周壁。
可选地,所述环形限位件为橡皮圈。
可选地,所述环形凹槽的凹槽侧壁形成有沿所述外筒体筒腔的轴向贯通的凹槽通气孔,所述外筒体筒腔在所述管塞与所述穿刺针安装端之间的筒腔区域连通所述凹槽通气孔。
可选地,所述采液管组件包括支撑管架,所述采液管插装在所述支撑管架的管架内腔中,所述环形凹槽设置在所述支撑管架的外周壁上。
可选地,所述采液管组件还包括支撑管架,所述采液管插装在所述支撑管架的管架内腔中,所述防晃动结构包括从所述支撑管架的外周壁或从外筒体内周壁凸出的限位凸起,该限位凸起的径向两端分别连接所述支撑管架的外周壁和所述外筒体内周壁。
可选地,所述房水采集装置还包括用于固定安装所述穿刺针的针座,所述针座的针座内端与所述穿刺针安装端之间形成快速插拔连接。
可选地,所述针座内端与所述穿刺针安装端之间形成螺纹插接或卡扣插接。
可选地,所述房水采集装置还包括用于沿所述外筒体筒腔的轴向隔离所述穿刺针内端与所述管塞的防刺破隔离件,该防刺破隔离件为可拆卸件。
可选地,所述外筒体的周壁设有隔离件插装槽,所述外筒体筒腔在所述穿刺针内端与所述管塞之间的筒腔区域连通所述隔离件插装槽,所述防刺破隔离件通过所述隔离件插装槽插入至所述筒腔区域内。
在一些实施例中,采液管组件由于设有管塞而使得采液管管腔处于负压状态,当穿刺针内端刺破管塞以将房水引流至采液管管腔时,随着管腔中的液体量逐渐增多,管腔内压力与前房内压力之差逐渐缩小,因此使得房水的引流速度逐渐降低,从而避免出现眼压骤降的危险情况,大大提高安全性。此外,由于限定了管塞与外筒体内周壁之间的静摩擦系数μ1小于管塞与所述采液管管口之间的静摩擦系数为μ2,或者将管塞间隔于外筒体内周壁设置,可保证在将采液管组件从外筒体筒腔中拔出时,管塞始终紧固地堵塞采液管管口,避免管腔中的房水与外界环境接触,保证所采集的房水的纯净度,且能够避免由于转移房水所造成的浪费,从而提高后续检测的可靠性。
在一些实施例中,本发明提供了一种房水采集装置,所述房水采集装置包括:
外筒体,设有穿刺针安装端和采液管安装端;
穿刺针,插装在所述穿刺针安装端中且包括穿刺针外端和伸入至外筒体筒腔内的穿刺针内端;
采液管组件,可插拔移动地从所述采液管安装端插入至所述外筒体筒腔内且包括采液管和用于密封在所述外筒体筒腔内的采液管管口的管塞;
其中,所述采液管组件与外筒体内周壁之间形成有通气结构,该通气结构连通所述外筒体筒腔在所述穿刺针内端与所述管塞之间的筒腔区域,所述房水采集装置还包括用于限位所述采液管组件沿径向位移且用于在所述采液管组件与所述外筒体内周壁之间形成接触阻尼的限位缓冲结构。
可选地,所述限位缓冲结构包括从所述采液管组件的外周壁或从所述外筒体内周壁凸出的限位凸起,该限位凸起的径向两端分别连接所述采液管组件的外周壁和所述外筒体内周壁。
可选地,所述限位缓冲结构包括沿所述采液管组件的管长方向依次间隔设置或者沿所述管长方向连续延伸的所述限位凸起,所述限位凸起沿所述管长方向的总跨度不小于采液管管长的一半。
可选地,所述限位凸起一体成型在所述采液管的外周壁上;或者,所述采液管组件包括外套在所述采液管的外周壁上的管套件,所述限位凸起设置在所述管套件的外周壁上。
可选地,所述管套件为弹性管套件。
可选地,所述限位缓冲结构包括沿周向依次间隔排布的多个所述限位凸起,多个所述限位凸起之间的间隙形成为所述通气结构;
或者,所述限位缓冲结构包括沿周向连续延伸成型的所述限位凸起,所述限位凸起与所述采液管组件的外周壁之间或所述限位凸起与所述外筒体内周壁之间形成有作为所述通气结构的排气间隙。
可选地,沿周向依次间隔排布的多个所述限位凸起均呈凸点状。可选地,沿周向连续延伸成型的所述限位凸起呈波纹状或斜齿状。
可选地,所述采液管组件还包括用于固定安装所述采液管的支撑管架,该支撑管架的外周壁与所述外筒体内周壁之间形成有所述限位缓冲结构。
可选地,所述采液管与所述支撑管架之间通过螺接固定或卡扣连接固定。
在一些实施例中,由于房水采集装置设有限位缓冲结构,能够在插拔采液管组件的过程中限位其沿着径向位移,即保证采液管组件只沿轴向移动,且能够产生一定的移动阻尼以防止插拔速度过快,因此不仅能保证穿刺针内端精准地刺破管塞以插入至采液管管腔内,还能保证在房水采集完毕后稳定地拔出采液管组件,以避免管腔内的房水泄漏,大大提高可靠性。此外,采液管组件由于 设有管塞而使得采液管管腔处于负压状态,当穿刺针内端刺破管塞以将房水引流至采液管管腔时,随着管腔中的液体量逐渐增多,管腔内压力与前房内压力之差逐渐缩小,因此使得房水的引流速度逐渐降低,从而避免出现眼压骤降的危险情况,大大提高安全性。再者,在采集完毕后,由于采液管组件能够从外筒体筒腔中整体拔出,并直接对采液管中的房水进行检测,无须作进一步转移,因此可避免管腔中的房水与外界环境接触,保证所采集的房水的纯净度,从而提高后续检测的准确性。
在一些实施例中,本发明提供了一种房水采集装置,所述房水采集装置包括:
外筒体,包括穿刺针安装端和采液管安装端;
穿刺针,固定安装于所述穿刺针安装端,所述穿刺针包括分别从所述穿刺针安装端的轴向两侧伸出的穿刺针内端和穿刺针外端;
采液管组件,包括从所述采液管安装端插入至外筒体筒腔内且能够沿轴向插拔移动的采液管和设置在所述外筒体筒腔内以用于密封采液管管口的管塞;
其中,所述管塞与所述外筒体筒腔同轴设置且所述管塞的半径小于外筒体内周壁的半径,所述采液管组件的外周壁设有环形凹槽和环箍所述环形凹槽设置的环形限位件,所述环形限位件的径向外端抵接所述外筒体内周壁。
可选地,所述管塞的径向外端与所述外筒体内周壁的径向间距不小于1mm。
可选地,所述采液管组件包括支撑管架,所述采液管插装在所述支撑管架的管架内腔中,所述环形凹槽设置在所述支撑管架的外周壁上。
可选地,所述采液管与所述支撑管架之间形成螺纹连接或卡扣连接。
可选地,所述环形凹槽的凹槽侧壁形成有沿所述外筒体筒腔的轴向贯通的凹槽通气孔,所述外筒体筒腔在所述管塞与所述穿刺针安装端之间的筒腔区域连通所述凹槽通气孔。
可选地,所述环形限位件为弹性件。
可选地,所述房水采集装置还包括用于固定安装所述穿刺针的针座,所述针座的针座内端与所述穿刺针安装端之间形成快速插拔连接。
可选地,所述针座内端与所述穿刺针安装端之间形成螺纹插接或卡扣插接。
可选地,所述房水采集装置还包括用于沿所述外筒体筒腔的轴向隔离所述穿刺针内端与所述管塞的防刺破隔离件,该防刺破隔离件为可拆卸件。
可选地,所述外筒体的周壁设有隔离件插装槽,所述外筒体筒腔在所述穿刺针内端与所述管塞之间的筒腔区域连通所述隔离件插装槽,所述防刺破隔离件通过所述隔离件插装槽插入至所述筒腔区域内。
在一些实施例中,采液管组件由于设有管塞而使得采液管管腔处于负压状态,当穿刺针内端刺破管塞以将房水引流至采液管管腔时,随着管腔中的液体量逐渐增多,管腔内压力与前房内压力之差逐渐缩小,因此使得房水的引流速度逐渐降低,从而避免出现眼压骤降的危险情况,大大提高安全性。此外,由于限定了管塞的半径小于外筒体内周壁的半径,因此管塞与外筒体内周壁不产生接触,可保证在将采液管组件从外筒体筒腔中拔出时,管塞始终紧固地堵塞采液管管口,避免管腔中的房水与外界环境接触,保证所采集的房水的纯净度,且能够避免由于转移房水所造成的浪费,从而提高后续检测的可靠性。
在一些实施例中,本发明提供了一种房水采集装置,所述房水采集装置包括:
外筒体,包括穿刺针安装端和采液管安装端;
穿刺针,固定安装于所述穿刺针安装端且设有位于外筒体筒腔内的穿刺针内端和位于所述外筒体筒腔外的穿刺针外端;
采液管组件,包括从所述采液管安装端插入至外筒体筒腔内且能够沿轴向插拔移动的采液管和设置在所述外筒体筒腔内以用于密封采液管管口的管塞;
其中,所述采液管组件的外周壁设有环形凹槽和环箍所述环形凹槽设置的环形限位件,所述环形限位件的径向外端抵接外筒体内周壁,所述管塞的径向外缘部与所述外筒体内周壁之间形成光滑接触并设有沿所述外筒体筒腔的延伸方向设置的管塞排气通道,所述外筒体筒腔在所述管塞与所述穿刺针安装端之间的筒腔区域连通所述管塞排气通道。
可选地,所述管塞设有沿所述外筒体筒腔的轴向延伸且沿所述管塞的周向依次间隔排布的多个所述管塞排气通道。
可选地,所述管塞的外周壁上形成有作为所述管塞排气通道的管塞排气凹槽,该管塞排气凹槽设有朝向径向外侧的凹槽开口。
可选地,所述管塞排气通道的通道周壁为封闭周壁。
可选地,所述管塞排气通道的横截面呈半圆形形状、方形形状或弧形形状。
可选地,所述管塞包括用于密封所述采液管管口的管塞中心部和位于所述管塞中心部的径向外侧且设有所述管塞排气通道的管塞外环部,所述管塞外环部至少部分形成为疏松通气结构。
可选地,所述管塞的端部设有用于引导所述穿刺针内端穿入的刺破导盲孔,所述穿刺针内端的外轮廓形状与所述刺破导盲孔的形状相互匹配。
可选地,所述采液管与外筒体内周壁之间设有周壁排气间隙,所述外筒体筒腔在所述管塞与所述穿刺针安装端之间的筒腔区域、所述管塞排气通道和所述周壁排气间隙依次连通。
可选地,所述穿刺针内端的外周壁上设有与所述穿刺针的针腔连通的周壁出水孔。
可选地,所述穿刺针内端还设有与所述针腔沿轴向连通的轴向出水孔,所述周壁出水孔的孔中心与所述轴向出水孔的孔中心的轴向间距为不大于3mm。
在一些实施例中,通过在管塞的径向外缘部设置管塞排气通道,能够使大气环境与外筒体筒腔在管塞与穿刺针安装端之间的筒腔区域连通,避免在外筒体筒腔中形成气栓而影响采液管组件的顺畅插拔,从而提高使用可靠性。此外,在引流过程中,采液管组件由于设有管塞而使得采液管管腔处于负压状态,当穿刺针内端刺破管塞以将房水引流至采液管管腔时,随着管腔中的液体量逐渐增多,管腔内压力与前房内压力之差逐渐缩小,因此使得房水的引流速度逐渐降低,从而避免出现眼压骤降的危险情况,大大提高安全性。再者,在采集完毕后,可将采液管组件从外筒体筒腔中整体拔出,并直接对采液管中的房水进行检测,无须作进一步转移,因此可避免管腔中的房水与外界环境接触,保证所采集的房水的纯净度,从而提高后续检测的准确性。
在一些实施例中,本发明提供了一种房水采集装置,所述房水采集装置包括:
外筒体,包括穿刺针安装端和采液管安装端;
穿刺针,固定安装于所述穿刺针安装端且设有位于外筒体筒腔内的穿刺针内端和位于所述外筒体筒腔外的穿刺针外端;
采液管,从所述采液管安装端插入至所述外筒体筒腔内且能够沿轴向插拔移动;
管塞,设置在所述外筒体筒腔内且用于密封采液管管口,所述管塞的径向外缘部设有沿所述外筒体筒腔的延伸方向设置的管塞排气通道,该管塞排气通道连通所述外筒体筒腔在所述管塞与所述穿刺针安装端之间的筒腔区域。
可选地,所述管塞设有沿所述外筒体筒腔的轴向延伸且沿所述管塞的周向依次间隔排布的多个所述管塞排气通道。
可选地,所述管塞的外周壁上形成有作为所述管塞排气通道的管塞排气凹槽,该管塞排气凹槽设有朝向径向外侧的凹槽开口。
可选地,所述管塞排气通道的通道周壁为封闭周壁。
可选地,所述管塞排气通道的横截面呈半圆形形状、方形形状或弧形形状。
可选地,所述管塞包括用于密封所述采液管管口的管塞中心部和位于所述管塞中心部的径向外侧且设有所述管塞排气通道的管塞外环部,所述管塞外环部至少部分形成为疏松通气结构。
可选地,所述管塞的端部设有用于引导所述穿刺针内端穿入的刺破导盲孔,所述穿刺针内端的外轮廓形状与所述刺破导盲孔的形状相互匹配。
可选地,所述采液管与外筒体内周壁之间设有周壁排气间隙,所述外筒体筒腔在所述管塞与所述穿刺针安装端之间的筒腔区域、所述管塞排气通道和所述周壁排气间隙依次连通。
可选地,所述穿刺针内端的外周壁上设有与所述穿刺针的针腔连通的周壁出水孔。
可选地,所述穿刺针内端还设有与所述针腔沿轴向连通的轴向出水孔,所述周壁出水孔的孔中心与所述轴向出水孔的孔中心的轴向间距为不大于3mm。
在一些实施例中,通过在管塞的径向外缘部设置管塞排气通道,能够使大气环境与外筒体筒腔在管塞与穿刺针安装端之间的筒腔区域连通,避免在外筒体筒腔中形成气栓而影响采液管组件的顺畅插拔,从而提高使用可靠性。此外,在引流过程中,采液管组件由于设有管塞而使得采液管管腔处于负压状态,当穿刺针内端刺破管塞以将房水引流至采液管管腔时,随着管腔中的液体量逐渐增多,管腔内压力与前房内压力之差逐渐缩小,因此使得房水的引流速度逐渐降低,从而避免出现眼压骤降的危险情况,大大提高安全性。再者,在采集完毕后,可将采液管组件从外筒体筒腔中整体拔出,并直接对采液管中的房水进行检测,无须作进一步转移,因此可避免管腔中的房水与外界环境接触,保证所采集的房水的纯净度,从而提高后续检测的准确性。
在一些实施例中,本发明提供了一种房水采集装置,所述房水采集装置包括外筒体、穿刺针和采液管组件,所述外筒体设有穿刺针安装端和采液管安装端,所述穿刺针插装在所述穿刺针安装 端中且包括穿刺针外端和插装至外筒体筒腔内的穿刺针内端,所述采液管组件从所述采液管安装端插入至所述外筒体筒腔内且包括可插拔移动的采液管和用于密封所述外筒体筒腔内的采液管管口的管塞;其中,所述房水采集装置还包括用于限位所述采液管组件沿所述外筒体筒腔径向位移的防晃动结构。
可选地,所述采液管组件还包括支撑管架,所述采液管插装在所述支撑管架的管架内腔中,所述防晃动结构包括从所述支撑管架的外周壁或从外筒体内周壁凸出的限位凸起,该限位凸起的径向两端分别连接所述支撑管架的外周壁和所述外筒体内周壁。
可选地,所述采液管与所述支撑管架之间通过螺接固定或卡扣连接固定。
可选地,所述限位凸起一体成型在所述支撑管架的外周壁上;或者,所述采液管组件包括外套在所述支撑管架的外周壁上的管套件,所述限位凸起设置在所述管套件的外周壁上。
可选地,所述管套件为弹性管套件。
可选地,所述防晃动结构包括沿周向依次间隔排布的多个所述限位凸起;
或者,所述防晃动结构包括沿周向连续延伸成型的所述限位凸起,所述限位凸起与所述支撑管架的外周壁之间或所述限位凸起与所述外筒体内周壁之间形成有排气间隙。
可选地,沿周向依次间隔排布的多个所述限位凸起均呈凸点状。
可选地,沿周向连续延伸成型的所述限位凸起呈波纹状或斜齿状。
可选地,所述防晃动结构包括沿所述采液管组件的管长方向依次间隔设置或沿所述管长方向连续延伸的限位凸起,该限位凸起沿所述管长方向的总跨度不小于采液管管长的一半。
在一些实施例中,由于房水采集装置设有防晃动结构,能够在插拔采液管组件的过程中限位其沿着径向位移,即保证采液管组件只沿轴向移动,因此不仅能保证穿刺针内端精准地刺破管塞以插入至采液管管腔内,还能保证在房水采集完毕后稳定地拔出采液管组件,以避免管腔内的房水泄漏,大大提高可靠性。此外,采液管组件由于设有管塞而使得采液管管腔处于负压状态,当穿刺针内端刺破管塞以将房水引流至采液管管腔时,随着管腔中的液体量逐渐增多,管腔内压力与前房内压力之差逐渐缩小,因此使得房水的引流速度逐渐降低,从而避免出现眼压骤降的危险情况,大大提高安全性。再者,在采集完毕后,由于采液管组件能够从外筒体筒腔中整体拔出,并直接对采液管中的房水进行检测,无须作进一步转移,因此可避免管腔中的房水与外界环境接触,保证所采集的房水的纯净度,从而提高后续检测的准确性。
在一些实施例中,本发明提供了一种从角膜收集房水的方法,包括:
将根据本发明提供的任意房水采集装置的穿刺针的穿刺针外端刺入眼睛的前房;
推动采液管组件的后端以使得所述采液管组件中的采液管朝向所述穿刺针的穿刺针内端移动,以使所述穿刺针内端穿过管塞进入所述采液管;
使前房的房水在眼内压和采液管之间的压差下穿过所述穿刺针并流入所述采液管;
从前房拉出所述房水采集装置;和从外筒体中取出所述采液管组件。
可选地,所述方法包括推动采液管组件的后端以使得所述采液管组件中的采液管朝向所述穿刺针的穿刺针内端移动,以使所述穿刺针内端穿过管塞进入所述采液管。可选地,所述方法包括用单手握住所述房水采集装置,并用食指轻推所述采液管组件的后端。
在一些实施例中,本发明提供了一种用于从受试者的眼睛收集房水的方法,包括将根据本发明提供的任意房水采集装置的穿刺针的穿刺针外端刺入眼睛的前房,其中,采液管内的压力低于受试者的眼内压;
推动采液管组件的后端以使得所述采液管组件中的所述采液管朝向所述穿刺针的穿刺针内端移动,以使所述穿刺针内端穿过管塞进入所述采液管;
使眼前房的房水在眼内压和负压之间的压差下穿过所述穿刺针并流入所述采液管;
从前房拉出所述房水采集装置;和
从外筒体中取出所述采液管组件。
可选地,所述方法包括推动采液管组件的后端以使得所述采液管组件中的所述采液管朝向所述穿刺针的穿刺针内端移动,以使所述穿刺针内端穿过管塞进入所述采液管。可选地,所述方法包括用单手握住所述房水采集装置,并用食指轻推所述采液管组件的后端。
可选地,所述方法进一步包括选择所述采液管内部的负压,所述负压低于受试者的眼睛的眼内压。
本发明的其它特征和优点将在随后的具体实施方式部分予以详细说明。
附图说明
附图是用来提供对本发明的进一步理解,并且构成说明书的一部分,与下面的具体实施方式一起用于解释本发明,但并不构成对本发明的限制。在附图中:
图1为本发明的具体实施方式中的试剂支架的示意图;
图2为本发明的具体实施方式中的弹簧机构的示意图;
图3为本发明的具体实施方式中的检测设备的示意图;
图4为本发明的具体实施方式中的盛液管的示意图;
图5为本发明的具体实施方式中的取液针的示意图;
图6为本发明的具体实施方式中的房水采集装置的立体图;
图7为图6中的房水采集装置的主视图;
图8为图7中的房水采集装置在穿刺针未刺破管塞时的主剖视图;
图9为图8中的房水采集装置设有防刺破隔离件时的主剖视图;
图10为图6中的房水采集装置的横截剖视图;
图11为图8中的房水采集装置的穿刺针设有周壁出水孔时的结构示意图;
图12为图8中的房水采集装置的管塞设有周壁开放式且呈半圆形的管塞排气通道时的结构示意图;
图13为图8中的房水采集装置的管塞设有周壁开放式且呈半矩形的管塞排气通道时的结构示意图;
图14为图8中的房水采集装置的管塞设有周壁封闭式且呈圆形的管塞排气通道时的结构示意图;
图15为图8中的房水采集装置的管塞设有周壁封闭式且呈弧形的管塞排气通道时的结构示意图;
图16为图8中的房水采集装置的采液管和支撑管架通过卡扣连接时的结构示意图;
图17为本发明的具体实施方式中的房水采集装置的采液管一体成型出凸点状的限位凸起时的结构示意图;
图18为本发明的具体实施方式中的房水采集装置的采液管一体成型出波纹状的限位凸起时的结构示意图;
图19为本发明的具体实施方式中的房水采集装置的采液管外套有管套件且限位凸起呈凸点状时的结构示意图;
图20为本发明的具体实施方式中的房水采集装置的采液管外套有管套件且限位凸起呈波纹状时的结构示意图;
图21为本发明的具体实施方式中的房水采集装置的采液管外套有管套件且限位凸起呈斜齿状时的结构示意图;
图22为本发明的具体实施方式中的房水采集装置的支撑管架一体成型出凸点状的限位凸起时的结构示意图;
图23为本发明的具体实施方式中的房水采集装置的支撑管架一体成型出波纹状的限位凸起时的结构示意图;
图24为本发明的具体实施方式中的房水采集装置的支撑管架一体成型出斜齿状的限位凸起时的结构示意图;
图25为本发明的具体实施方式中的房水采集装置的支撑管架外套有管套件且限位凸起呈凸点状时的结构示意图;
图26为本发明的具体实施方式中的房水采集装置的支撑管架外套有管套件且限位凸起呈波纹状时的结构示意图;
图27为本发明的具体实施方式中的房水采集装置的支撑管架外套有管套件且限位凸起呈斜齿状时的结构示意图;
图28为本发明的具体实施方式中的转换插座的结构示意图;
图29为本发明的具体实施方式中的动物试验中的各组前房水采集量及各组目标采集量(50μl)的偏差绝对值(absolute deviation from the target volume(ADTV))的对比示意图;
图30为本发明的具体实施方式中的动物试验中的各亚组的操作时间(operation time)的示意图;
图31为本发明的具体实施方式中的动物试验中的第1组代表性兔子的前节评估示意图。
附图标记说明:
1          外筒体           2           穿刺针
3          采液管组件       4           针座
5          防刺破隔离件     6           限位凸起
7          针帽             8           软套
11         隔离件插装槽     21          周壁出水孔
22         轴向出水孔       31          采液管
32         支撑管架         33          管塞
34         管套件           35          环形凹槽
36         凹槽通气孔       37          环形限位件
311        采液管卡槽       321         管架卡扣
322        管架卡扣按钮     331         管塞排气通道
332        刺破导盲孔
9          试剂支架         10          检测设备
91         盛液管插装孔     92          功能位外套筒
93         弹簧机构         94          左锚定片
95         样本位           96          稀释位
97         洗液位           98          试剂位
99         测光位           910         反应位
911        底物位           912         预留位
913        右锚定片         914         转换插座
101        外壳             102         反应仓
103        舱门             104         取液针
105        试剂支架位       106         盛液管
93a        支撑凹位         914a        支撑套筒部
914b       延伸套筒部       104a        倾斜端面
104b       针身段中心轴线   104c        取液口中心轴线
具体实施方式
以下结合附图对本发明实施例的具体实施方式进行详细说明。应当理解的是,此处所描述的具体实施方式仅用于说明和解释本发明实施例,并不用于限制本发明实施例。
需要说明的是,在不冲突的情况下,本发明中的实施例及实施例中的特征可以相互组合。
在本发明实施例中,在未作相反说明的情况下,使用的方位词如“上、下、顶、底”通常是针对附图所示的方向而言的或者是针对竖直、垂直或重力方向上而言的各部件相互位置关系描述用词。
下面将参考附图并结合示例性实施例来详细说明本发明。
在一些实施例中,例如图1至图5所示,本发明提供了一种试剂支架9,该试剂支架9可被设置为图示的条形支架。其中,试剂支架9包括支架本体和设置在支架本体上的功能位,该功能位包括盛液管插装孔91和弹性部件,弹性部件设置为:在盛液管插装孔91内插装有盛液管106的情况下,能够弹性作用于盛液管106,以使得盛液管106能够沿盛液管插装孔91的孔中心轴线方向弹性移动。
通过设置上述结构,当检测设备10中的取液装置伸入盛液管106的管腔内取液且触碰到其底壁时,盛液管106由于受到试剂支架9中的弹性部件的弹性作用,能够沿盛液管插装孔91的孔中心轴线方向弹性移动,从而将取液装置与盛液管106的底壁的刚性碰撞转化为弹性碰撞,在弹性碰撞情况下,检测设备不会触发撞针保护功能。换言之,在采用本发明的试剂支架9弹性固定盛液管106的情况下,取液装置伸入盛液管106的管腔内的深度得以大大增加,从而可有效增加样本提取量。
在一种实施例中,功能位还包括功能位外套筒92,该功能位外套筒92从盛液管插装孔91的内周壁沿孔中心轴线方向向下伸出。此时,可将弹性部件设置在功能位外套筒92的套筒内腔,例如可设置在套筒内腔的底部或周部,只要保证盛液管106能够沿盛液管插装孔91的孔中心轴线方向弹性移动即可。
在一种实施例中,可将弹性部件设置为弹簧机构93或弹性介质。当弹性部件设置为弹性介质 时,可将弹性介质填充在功能位外套筒92的内壁与盛液管106的外壁之间。当弹性部件设置为弹簧机构93时,参照图1和图2,可将弹簧机构93设置在功能位外套筒92的套筒内腔的底部且该弹簧机构93能够沿孔中心轴线方向弹性移动,并且在弹簧机构93的弹性移动过程中,可将弹簧机构93的外周部设置为至少部分贴合套筒内腔的内周壁滑移,以保证作用于盛液管106的弹性作用力始终沿盛液管插装孔91的孔中心轴线方向。
在一种实施例中,当弹性部件设置在功能位外套筒92的套筒内腔的底部时,可在弹性部件的顶部中心设置支撑凹位93a,该支撑凹位93a用于支撑盛液管106的底部。例如,参照图4,可将盛液管106的底部外轮廓设置为呈倒锥形,此时支撑凹位93a的形状匹配于盛液管106的底部外轮廓。当盛液管106的底部支撑在支撑凹位93a时,可保证盛液管106始终维持直立状态。
在一些实施例中,本发明提供了一种盛液管适配器,其特征在于,包括适配器本体和设置在所述适配器本体上的盛液管放置位,所述适配器本体设置为可安装在样品处理或分析仪器上或内部的功能位,所述盛液管放置位设置为可容纳外径为3mm至8mm,长度为20mm至30mm的盛液管,且所述盛液管与所述功能位的相对位置由所述盛液管适配器固定。在一些实施例中,所述适配器本体设置为可拆卸地安装在所述功能位。在一些实施例中,所述适配器本体设置为固定地安装在所述功能位。
在一些实施例中,所述盛液管可拆卸地插装在所述盛液管放置位中。在一些实施例中,所述适配器本体外周部至少部分贴合所述功能位的内周壁。在一些实施例中,所述盛液管外周部至少部分贴合所述适配器本体内周壁和/或所述盛液管放置位内周壁。
在一些实施例中,所述样品处理或分析仪器包括离心机,光谱仪,及其它仪器。
在一些实施例中,所述盛液管放置位包括盛液管插装孔。在一些实施例中,所述盛液管放置位还包括弹性部件,所述弹性部件设置为:在所述盛液管插装孔内插装有盛液管的情况下,能够弹性作用于所述盛液管,以使得所述盛液管能够沿所述盛液管插装孔的孔中心轴线方向弹性移动。
在一些实施例中,所述盛液管放置位还包括外套筒,所述外套筒沿所述盛液管插装孔的内周壁设置,所述弹性部件位于所述外套筒的套筒内腔。
在一些实施例中,所述盛液管放置位还包括外套筒,所述外套筒沿所述盛液管插装孔的内周壁设置,在所述盛液管插装孔内插装有盛液管的情况下,所述外套筒能够弹性作用于所述盛液管,以使得所述盛液管能够沿所述盛液管插装孔的孔中心轴线方向弹性移动。
在一些实施例中,本发明提供了一种组合,其特征在于,包括盛液管及根据本发明提供的任意盛液管适配器。
在一种实施例中,参照图28,试剂支架9还包括可拆卸地插装于盛液管插装孔91内的转换插座914,该转换插座914包括上下连接的支撑套筒部914a和延伸套筒部914b。其中,支撑套筒部914a的套筒腔与延伸套筒部914b的套筒腔上下连通且共同形成为转换插装腔,该转换插装腔用于供盛液管106可拆卸地插入。通过选择不同尺寸的转换插座914,能够始终保证盛液管106适配固定至不同尺寸的盛液管插装孔91内,从而避免盛液管106难于稳定安装。
进一步地,可将前述的弹性部件设置在转换插座914的转换插装腔内,以使得取液装置伸入盛液管106的管腔内的深度得以大大增加,从而可有效增加样本提取量。
需要说明的是,功能位可包括样本位95、试剂位98、测光位99、反应位910或预留位912等,可根据实际检测需要进行设置。
此外,在一些实施例中,本发明提供了一种检测设备总成,该检测设备总成包括检测设备10、盛液管106和上述的试剂支架9。
其中,盛液管106可拆卸地插装在盛液管插装孔91内且能够受到弹性部件的弹性作用以沿盛液管插装孔91的孔中心轴线方向弹性移动。在试剂支架9设有功能位外套筒92的情况下,盛液管106可穿过盛液管插装孔91以插入至功能位外套筒92的套筒内腔,且优选地,此时盛液管106的顶端不高于盛液管插装孔91的孔口,并且盛液管106的管口外径与套筒内腔的内径相同,以防止盛液管106的晃动,提高其安装稳定性。此外,检测设备10包括取液装置,该取液装置设置为用于伸入盛液管106的管腔内取液,例如,取液装置可设有用于伸入盛液管106的管腔内取液的取液针104。
通常地,为避免取液针104因刚性碰撞而损坏,检测设备10会设有撞针保护功能,该撞针保护功能能够在取液针104受到刚性碰撞时使检测设备10报错并停止工作。而在盛液管106受到弹性部件的弹性作用的情况下,当取液针104触碰到盛液管106的底壁时,可将刚性碰撞转化为弹性碰撞,从而避免在取液过程中触发撞针保护功能,因此取液针104能够伸入较深位置取液,从而增加提取量。
为满足取液针104在接触到盛液管106的底壁时还能顺畅取液,可对取液针104进行重新设计,其原因在于,现有的取液针104中设有取液口的外端面为平面端面,盛液管106的底壁通常为平面壁,当平面端面与平面壁接触时,二者易形成紧密接触而导致取液口被密封,从而导致取液针104无法取液。
因此在一种实施例中,为保证取液针104的顺畅取液,可将取液针104的外端面形成为倾斜端面104a且倾斜端面104a上形成有取液口。在此结构下,无论盛液管106的底壁设置为平面壁等不同形状,也不易于密封取液口。由此可见,本发明的检测设备总成有利于增加取液时的样本提取量,并能保证在取液过程中的顺畅取液。
在一种实施例中,取液针104沿直线延伸且包括相互连接的针身段和针头段,针头段的外端形成有取液口,由于针头段的外端面为倾斜端面,因此参照图5,针身段的针身段中心轴线104b与取液口的取液口中心轴线104c相交。具体地,针身段中心轴线104b与取液口中心轴线104c相交形成的锐角夹角为α,且α可满足:0<α≤0.1°。
需要说明的是,可将倾斜端面104a设置为曲面或平面,或者将盛液管106的管腔内底壁设置为平面壁或曲面壁,只要保证取液针104在与盛液管106的底壁接触时仍保证取液口的非密封状态即可。
下面以用于房水样本检测的化学发光免疫分析仪为例阐述本发明的检测设备总成的检测过程,但应当理解的是,本发明的检测设备总成中还可设置其他类型或领域的检测设备,而不仅限于该化学发光免疫分析仪。
当检测设备为化学发光免疫分析仪时,试剂支架9呈条形且可设有从左到右依次布置的左锚定片94、样本位95、稀释位96、洗液位97、试剂位98、测光位99、反应位910、底物位911、预留位912以及右锚定片913。当然,各功能位的排列顺序也可根据实际情况另行设置。
其中,样本位用于放置集液管,试剂位用于预装试剂,测光位用于检测光信号,反应位用于各组分进行反应,预留位用于为其他种类测试扩展备用。化学发光免疫分析仪包括外壳101、反应仓102、舱门103、上述取液针104和试剂支架位105。
在对房水样本进行检测时,打开反应仓102的舱门103,将插装有盛液管106的试剂支架9放入试剂支架位105,关闭舱门103。然后开始检测,化学发光免疫分析仪先通过取液针104将房水样本与试剂依次从相应位置取出并加入至反应位910进行温浴,然后转移至洗液位97进行清洗,再转移至底物位911进行催化,最后转移至测光位99进行测光。
在一些实施例中,例如图6至图21所示,本发明提供了一种房水采集装置,该房水采集装置包括外筒体1、穿刺针2和采液管组件3。外筒体1设有位于轴向两端的穿刺针安装端和采液管安装端。穿刺针2可固定安装于穿刺针安装端,固定安装可以是固定连接,也可以是可拆卸连接。当穿刺针2固定安装于穿刺针安装端时,穿刺针可设有位于外筒体筒腔内的穿刺针内端和位于外筒体筒腔外的穿刺针外端。采液管组件3可包括从采液管安装端插入至外筒体筒腔内且能够沿轴向插拔移动的采液管31和设置在外筒体筒腔内以用于密封采液管管口的管塞33。可选地,管塞33与外筒体内周壁直接接触而采液管31与外筒体内周壁不直接接触。可选地,管塞33与外筒体内周壁形成可滑动性接触,例如具有一定接触阻力的可滑动性接触,以控制采液管31沿外筒体筒腔轴向插拔移动并保持其稳定性。优选地,管塞33与外筒体内周壁之间的静摩擦系数为μ1,管塞33与采液管管口之间的静摩擦系数为μ2,且满足:μ1<μ2。或者,可将管塞33间隔于外筒体内周壁设置,以保证管塞33与外筒体内周壁互不直接接触。例如,采液管31与外筒体内周壁直接接触而管塞33与外筒体内周壁不直接接触。可选地,采液管31(例如采液管的管口外周)可与外筒体内周壁形成可滑动性接触,例如具有一定接触阻力的可滑动性接触,以控制采液管沿外筒体筒腔轴向插拔移动并保持其稳定性。可选地,管塞33与采液管31均间隔于外筒体内周壁设置,以保证管塞33及采液管31与外筒体内周壁均互不直接接触。例如,房水采集装置可包括用于固定安装采液管31的支撑管架32,该支撑管架的外周壁与外筒体内周壁形成可滑动性接触,例如具有一定接触阻力的可滑动性接触,以带动并控制采液管和管塞沿外筒体筒腔轴向插拔移动并保持其稳定性。
在一些实施例中,在采用本发明的示例性实施例中的房水采集装置进行前房穿刺时,可将采液管组件3朝向穿刺针内端推移,使得穿刺针内端刺破软套8和管塞33后插入至采液管管腔中,以将前房中的房水通过穿刺针外端和穿刺针内端引流至采液管管腔。在此采集过程中,由于采液管管口被管塞33密封,采液管管腔始终处于负压状态,但随着管腔中的液体量逐渐增多,管腔内压力与前房内压力之差逐渐缩小,因此会使得房水的引流速度逐渐降低,从而避免出现眼压骤降的危险情况,大大提高穿刺引流的安全性。此外,可选地,采液管31上可以设置标记线以标记采液管31的 最佳移动距离,从而在穿刺针内端刺破管塞33时手指无须过度用力而影响采液管和管塞沿外筒体筒腔轴向移动的稳定性。可选地,房水采集装置可包括限位凸起6,有助于采液管和管塞沿外筒体筒腔轴向移动的稳定性。
在一些实施例中,当房水采集完毕后,可将采液管组件3从外筒体筒腔中整体拔出,继而直接将采液管31放置于特定检测仪器中进行特定项目检测,与现有技术相比,无须对采集后的房水作进一步转移,因此可避免采液管管腔中的房水与外界环境接触,保证所采集的房水的纯净度,从而提高后续检测的准确性和可靠性,且能够避免由于转移房水所造成的浪费。
在一些实施例中,由于限定了管塞33与外筒体内周壁之间的静摩擦系数μ1小于管塞33与所述采液管管口之间的静摩擦系数为μ2,或者将管塞33间隔于外筒体内周壁设置,可保证在将采液管组件3从外筒体筒腔中整体拔出时,管塞33始终紧固地堵塞采液管管口,从而更可靠地保证所采集的房水的纯净度。
在一些实施例中,当管塞33与外筒体内周壁相互接触时,为更好地避免管塞33脱落,将管塞33与外筒体内周壁之间优选设置为通过光滑面接触。例如,可将管塞33的径向外端面或外筒体内周壁面设置为光滑面,或者同时将管塞33的径向外端面和外筒体内周壁面设置为光滑面。
在一些实施例中,房水采集装置包括用于限位采液管组件3沿外筒体筒腔径向位移的防晃动结构。在一些实施例中,防晃动结构有助于采液管组件在插拔移动过程中沿轴向移动而减少或不会出现径向晃动。例如,在此结构下,可保证采液管组件3在插拔移动过程中只沿轴向移动而不会出现径向晃动,不仅能保证在穿刺过程中穿刺针内端精准地刺破管塞33以插入至采液管管腔内,还能保证在房水采集完毕后稳定地拔出采液管组件3,以避免采液管管腔内的房水泄漏,从而进一步提高后续检测的准确性和可靠性。
在一些实施例中,如图8和图9所示,防晃动结构可包括形成在采液管组件3的外周壁上的环形凹槽35和环箍环形凹槽35设置的环形限位件37,该环形限位件37的径向外端抵接外筒体内周壁。需要说明的是,环形限位件37除了能够防止采液管组件3的径向晃动以使得穿刺过程中穿刺针内端扎破管塞33时更为准确而防止偏位以外,还能适当地增大采液管组件3的插拔阻力,使操作人员能够感受到一定的推移手感,从而避免在将采液管组件3朝向穿刺针内端推移时由于推移速度过快而造成刺破不精准的情况,进而避免穿刺针内端不能插入至采液管管腔内,即有效提高穿刺引流过程的稳定性和可靠性。此外,还可防止在拿取房水采集装置时采液管组件3与外筒体分离脱落,从而提高产品的可靠性。优选地,可设置多组环形凹槽35和对应的环形限位件37,以获得更好的效果。
在一些实施例中,本发明的房水采集方法在穿刺针外端刺入眼睛的前房后,包括推动采液管组件的后端使采液管朝向穿刺针内端移动,以使穿刺针内端刺破软套8和管塞33后插入至采液管管腔中。可选地,原本覆盖插入至采液管管腔中的穿刺针内端部分的软套被管塞压缩而产生回弹力。可选地,仍覆盖穿刺针内端未插入管塞及采液管管腔中部分的被压缩的软套与穿刺针内端之间具有一定摩擦力。可选地,穿刺针内端与被穿透的管塞之间,和/或环形限位件与外筒体内周壁之间,均可具有一定摩擦力。
在一些实施例中,在穿刺针外端刺入眼睛的前房及穿刺针内端插入至采液管管腔后,前房中的房水在采液管管腔内压力与前房内压力之差作用下,通过穿刺针外端和穿刺针内端引流至采液管管腔。在房水采集过程中,随着管腔中的液体量逐渐增多,管腔内压力与前房内压力趋向于达到平衡,房水逐渐停止通过穿刺针引流至采液管管腔。可选地,从穿刺针内端插入至采液管管腔起计时,到管腔内压力与前房内压力达到平衡和/或房水停止引流所需时间为或约为1s、2s,、3s、4s、5s、6s、7s、8s、9s、10s、11s、12s、13s、14s、15s、16s、17s、18s、19s、20s、21s、22s、23s、24s、25s、26s、27s、28s、29s、30s或更长时间。
在一些实施例中,本发明的房水采集方法在穿刺针外端刺入眼睛的前房及穿刺针内端插入至采液管管腔后,包括保持穿刺针内端插入采液管管腔内一段时间的步骤。可选地,保持穿刺针内端插入采液管管腔内直至管腔内压力与前房内压力达到平衡。可选地,保持穿刺针内端插入采液管管腔内直至房水停止引流。可选地,保持穿刺针内端插入采液管管腔内可包括对采液管组件3维持或施加外力,以防止穿刺针内端弹出采液管管腔。可选地,从穿刺针内端插入至采液管管腔起计时,对采液管组件3维持或施加外力可持续至管腔内压力与前房内压力达到平衡。可选地,从穿刺针内端插入至采液管管腔起计时,对采液管组件3维持或施加外力可持续至房水停止引流。可选地,从穿刺针内端插入至采液管管腔起计时,保持穿刺针内端插入采液管管腔内可持续或持续约1s、2s、3s、4s、5s、6s、7s、8s、9s、10s、11s、12s、13s、14s、15s、16s、17s、18s、19s、20s、 21s、22s、23s、24s、25s、26s、27s、28s、29s、30s或更长时间。可选地,从穿刺针内端插入至采液管管腔起计时,对采液管组件3维持或施加外力可持续或持续约1s、2s、3s、4s、5s、6s、7s、8s、9s、10s、11s、12s、13s、14s、15s、16s、17s、18s、19s、20s、21s、22s、23s、24s、25s、26s、27s、28s、29s、30s或更长时间。
在一些实施例中,在穿刺针外端退出前房且停止对采液管组件施加外力后(例如,食指松开后),采液管组件可回弹,从而使穿刺针内端自然弹出采液管管腔及管塞。例如,将采液管组件3从外筒体筒腔中整体拔出的整个过程中,可将穿刺针内端与软套8之间的摩擦力、穿刺针内端与被穿透的管塞33之间的摩擦力以及环形限位件37与外筒体内周壁之间摩擦力之和设置为小于软套8的回弹力,使得在穿刺针外端退出前房且食指松开采液管组件3后穿刺针内端能够自然弹出采液管管腔及管塞,而无须专门通过向外拔采液管组件3而使穿刺针内端退出采液管管腔及管塞,从而简化操作。此外,还可将软套8设置为弹簧结构或包含弹簧结构的软套,如此既能保证软套8在穿刺过程中的稳定形变,又能提高软套8回弹时回弹力的稳定性,进一步有助于采液管组件在插拔移动过程中沿轴向移动而减少或不会出现径向晃动。
在一些实施例中,为降低生产难度和降低生产成本,可将环形限位件37优选设置为易于获取、低廉物美的橡皮圈或其他弹性圈,且该弹性材质制成的环形限位件37与外筒体内周壁之间形成弹性接触,可避免过度摩擦而磨损外筒体内周壁。
在一些实施例中,可在环形凹槽35的凹槽侧壁形成有沿外筒体筒腔的轴向贯通的凹槽通气孔36,使得外筒体筒腔在管塞33与穿刺针安装端之间的筒腔区域能够通过该凹槽通气孔36与大气环境连通,以避免在外筒体筒腔中形成气栓而影响采液管组件3的顺畅插拔,从而提高房水采集装置的使用可靠性。
在一些实施例中,如图17至图21所示,防晃动结构还可包括从采液管组件3的外周壁或从外筒体内周壁凸出的限位凸起6,该限位凸起6的径向两端分别连接采液管组件3的外周壁和外筒体内周壁,从而防止采液管组件3产生径向晃动。
在一些实施例中,当限位凸起6设置在采液管组件3的外周壁时,可将限位凸起6一体成型在采液管31的外周壁上。或者,可在采液管组件3中设置外套于采液管31的外周壁上的管套件34,并将限位凸起6设置在管套件34的外周壁上,由于管套件34为可拆卸件,因此能够重复利用,且在管套件34上成型出限位凸起6的难度相对更小,更有利于降低生产成本。
在一些实施例中,可将管套件34设置为弹性管套件,以防止采液管31在受到径向限位作用时由于刚性接触而破裂,从而减少房水泄漏的风险。
在一些实施例中,防晃动结构可包括沿周向依次间隔排布的多个限位凸起6,可保证采液管31与外筒体筒腔同轴设置,从而保证采液管31沿轴向顺畅插拔移动。此外,由于相互间隔的多个限位凸起6之间形成有排气间隙,外筒体筒腔在穿刺针安装端与管塞33之间的筒腔区域可通过该排气间隙连通大气环境,从而避免在外筒体筒腔中形成气栓而影响采液管组件3的顺畅插拔。例如,参照图17和图19,沿周向依次间隔排布的多个限位凸起6可设置为呈凸点状。
在一些实施例中,限位凸起6也可沿周向连续延伸成型。当限位凸起6形成在外筒体内周壁时,限位凸起6与采液管组件3的外周壁之间优选地形成有排气间隙,以避免形成气栓。当限位凸起6形成在采液管组件3的外周壁时,限位凸起6与外筒体内周壁之间也优选地形成有排气间隙。例如,参照图18、图20和图21,沿周向连续延伸成型的限位凸起6可设置为呈波纹状或斜齿状。
在一些实施例中,为进一步提高采液管组件3的插拔稳定性,无论限位凸起6是沿采液管组件3的管长方向依次间隔设置,或者是沿管长方向连续延伸成型,均优选地将限位凸起6沿管长方向的总跨度设置为不小于采液管管长的一半。换言之,当限位凸起6在沿管长方向上的布置数量足够多时,可避免在采液管组件3的外周壁上形成杠杆支点,从而更可靠地防止采液管组件3沿径向晃动。
在一些实施例中,采液管组件3还包括用于固定安装采液管31的支撑管架32。在此结构下,可将防晃动结构设置在支撑管架32的外周壁与外筒体内周壁之间,例如可参照图22至图27所示。该支撑管架32能够更好地提高采液管组件3的稳定性以及能够降低采液管组件3由于受到碰撞或按压推移而破裂的风险。
在一些实施例中,在房水采集完毕后,需要将采液管单独取出,因此采液管31与支撑管架32之间的连接方式要同时满足稳定性和快速拆装的要求。优选地,采液管31与支撑管架32之间可通过螺接固定或卡扣连接固定。
例如,参照图16,采液管31与支撑管架32之间通过卡扣连接,当需要将采液管31插装在支 撑管架32中时,将采液管31向右推移,直至管架卡扣321卡入采液管卡槽311中,即可使得采液管31与支撑管架32相互卡扣锁止。当需要取出采液管31时,可按压管架卡扣按钮322,使得管架卡扣321抬升以脱离采液管卡槽311,即可将采液管31从支撑管架32中快速取出。
在一些实施例中,房水采集装置还包括用于固定安装穿刺针2的针座4。其中,穿刺针外端从针座外端伸出且穿刺针内端从针座内端伸出,并且针座内端与穿刺针安装端之间形成快速插拔连接,有利于降低安装难度,从而提高装配效率。例如,针座内端与穿刺针安装端之间可形成螺纹插接或卡扣插接。
在一些实施例中,房水采集装置还包括防刺破隔离件5,该防刺破隔离件5用于沿外筒体筒腔的轴向将穿刺针内端与管塞33相互隔离,以防止在未使用房水采集装置进行前房穿刺的情况下穿刺针内端刺破管塞33,即有效避免装置在未使用前失效。例如,在运输途中或医护人员误操作等情况下,该防刺破隔离件5可防止房水采集装置失效。当然,为了不影响房水采集装置的正常穿刺引流,将防刺破隔离件5设置为可拆卸件,在进行穿刺之前,即可将防刺破隔离件5拆除。
例如,参照图9,可在外筒体1的周壁设置隔离件插装槽11,并使得该隔离件插装槽11与外筒体筒腔在穿刺针内端与管塞33之间的筒腔区域相互连通,防刺破隔离件5可通过该隔离件插装槽11插入至该筒腔区域内,并置于穿刺针内端与管塞33之间,从而将穿刺针内端与管塞33相互隔离。在需要拆除防刺破隔离件5时,可将其从隔离件插装槽11中快速拔出,操作相当方便。
在一些实施例中,房水采集装置还包括可拆卸的限位结构,以防止在运输途中由于震动或医护人员误操作等情况下,穿刺针内端刺破管塞而使房水采集装置失效和/或采液管组件3从外筒体中脱落。可选地,在包装好或未使用的房水采集装置中,该限位结构位于支撑管架后端。可选地,在包装好或未使用的房水采集装置中,该限位结构位于外筒体采液管安装端。可选地,在包装好或未使用的房水采集装置中,该限位结构至少有一部分位于外筒体采液管安装端与支撑管架后端之间,例如,该限位结构可包括套在支撑管架后端的卡位块,卡在外筒体采液管安装端与支撑管架后端之间。可选地,该限位结构可防止支撑管架与外筒体发生轴向的相对位移,以防止在未使用房水采集装置进行前房穿刺的情况下穿刺针内端刺破管塞33,和/或防止采液管组件3由于重力或外力作用从外筒体中脱落。该限位结构为可拆卸件,在进行穿刺之前,即可将其拆除。
在一些实施例中,如图12至图15所示,为更好地避免在外筒体筒腔内形成气栓而影响采液管组件3的顺畅插拔,可在管塞33的径向外缘部形成沿外筒体筒腔的延伸方向设置的管塞排气通道331,外筒体筒腔在管塞33与穿刺针安装端之间的筒腔区域可通过该管塞排气通道331以及上述的采液管31与外筒体内周壁之间的周壁排气间隙连通大气环境。换言之,外筒体筒腔在管塞33与穿刺针安装端之间的筒腔区域、管塞排气通道331和周壁排气间隙依次连通以及大气环境依次连通。
在一些实施例中,为提高通气效果以及使管塞33的结构更加均匀合理,设置沿外筒体筒腔的轴向延伸,并沿管塞33的周向依次间隔排布的多个管塞排气通道331。
管塞排气通道331的具体形状可视实际需要而定。在一些实施例中,参照图12和图13,可在管塞33的外周壁上形成有作为管塞排气通道331的管塞排气凹槽,该管塞排气凹槽设有朝向径向外侧的凹槽开口。换言之,可将管塞排气通道331设置为周壁开放式的排气通道。或者,参照图14和图15,可将管塞排气通道331的通道周壁设置为封闭周壁,即可将管塞排气通道331设置为周壁封闭式的排气通道。此外,管塞排气通道331的横截面可设置为呈半圆形、方形或弧形等不同形状。
在一些实施例中,管塞33包括用于密封采液管管口的管塞中心部和位于管塞中心部的径向外侧且设有管塞排气通道331的管塞外环部,为保证实现内外通气,可将管塞外环部至少部分设置为疏松通气结构,但依然需要保证管塞中心部具有密封性。
在一些实施例中,为保证穿刺针内端在刺破管塞33时不会产生晃动而影响刺破精确性,可在管塞33的端部设置用于引导穿刺针内端穿入的刺破导盲孔332,并使得穿刺针内端的外轮廓形状与刺破导盲孔332的形状相互匹配。例如,参照图8,可将穿刺针内端和刺破导盲孔332设置为相互匹配的长锥形形状。
需要说明的是,在穿刺针内端刺破管塞33的过程中,可能会出现穿刺针内端的轴向出水孔22被管塞材料堵塞的情况,从而导致引流被阻断而使得装置不能正常工作。因此,在一些实施例中,为避免出现断流情况,可在穿刺针内端的外周壁上设置与穿刺针2的针腔连通的周壁出水孔21,在此结构下,即使轴向出水孔22被管塞材料堵塞,房水也能通过周壁出水孔21流出至采液管管腔内,从而保证装置的工作可靠性。
此外,周壁出水孔21与轴向出水孔22的轴向间距不宜过大,否则当轴向出水孔22插入至采液管管腔后,周壁出水孔21依然位于管塞33中而被堵塞,从而导致周壁出水孔21失去效用。为此, 在一些实施例中,可将周壁出水孔21的孔中心与轴向出水孔22的孔中心的轴向间距优选设置为不大于3mm,以保证当轴向出水孔22插入至采液管管腔后,周壁出水孔21也可位于采液管管腔内而不会被堵塞。
下面对本示例性实施例的房水采集装置中的部分构件等的可选参数设置进行说明。
在一些实施例中,穿刺针2的外径可设置为0.31mm(30G)至0.91mm(20G)且内径可根据外径作调整。可选地,穿刺针2的外径可设置为0.5mm(25G)且内径最小为约0.232mm。可选地,穿刺针2的外径为或约为0.3mm、0.4mm、0.5mm、0.6mm、0.7mm、0.8mm或0.9mm。可选地,穿刺针2的内径为0.15mm至0.45mm,例如穿刺针2的内径为或约为0.1mm、0.2mm、0.3mm或0.4mm。
在一些实施例中,穿刺针2的总长度可设置为20mm至65mm,例如穿刺针2的总长度为或约为25mm、30mm、35mm、40mm、45mm、50mm、55mm或60mm。可选地,穿刺针2从针座4向外伸出的伸出长度可设置为1.5mm至15mm,例如1.5mm至5mm,5mm至7.5mm,7.5mm至10mm,10mm至12.5mm或12.5mm至15mm,优选为6mm。可选地,穿刺针2从针座4向内伸出的伸出长度可设置为10mm至30mm,例如10mm至15mm,15mm至20mm,20mm至25mm,或25mm至30mm,优选为15mm。考虑到模具的稳定性,可选地,穿刺针2位于针座4中的部分的长度可设置为10mm至20mm,例如10mm至15mm,或15mm至20mm,优选为14mm。可选地,例如穿刺针2的总长度为或约为35mm,从针座4向外伸出的伸出长度为或约为6mm,从针座4向内伸出的伸出长度为或约为15mm,位于针座4中的部分的长度为或约为14mm。
穿刺针2的针尖斜角可设置为5°至50°,例如可设置为8°、10°、12°、15°、17°、19°、43°、45°、47°等。
在一些实施例中,穿刺针2所采集的房水的体积可以是10μL至100μL,例如可设置为32μL、37.5μL、40μL、45μL、48μL、50μL、51μL、55μL、60μL、62.5μL、69μL等。
在一些实施例中,穿刺针2所采集的房水的目标体积可以是10μL至100μL,例如可设置为32μL、37.5μL、40μL、45μL、48μL、50μL、51μL、55μL、60μL、62.5μL、69μL等。在一些实施例中,使用本发明的房水采集装置和方法有助于房水采集的准确度,例如,所采集的房水的体积可以达到目标体积±1%,目标体积±5%,目标体积±10%,目标体积±15%,目标体积±20%,或目标体积±25%。
在一些实施例中,采液管31的外形可兼容离心机,其可承受的最大离心力为4000g n
在一些实施例中,设有管塞33的采液管31(即负压的采液管31)的容积可设置为8μL至310μL(例如可设置为10μL、50μL、100μL、150μL、200μL、250μL、300μL等),其气压范围可设置为1*103Pa至1*104Pa。可选地,设有管塞33的采液管31(即负压的采液管31)内气压范围设置为8mmHg至40mmHg之间,例如8mmHg至10mmHg,10mmHg至15mmHg,15mmHg至20mmHg,20mmHg至25mmHg,25mmHg至30mmHg,30mmHg至35mmHg,或35mmHg至40mmHg。
在一些实施例中,采液管31的内径可设置为2.5mm至6mm,外径可设置为3mm至8mm,管长可设置为20mm至30mm。
外筒体1的外径可设置为6mm至16mm,支撑管架32的长度可设置为20mm至50mm且当支撑管架32为圆性管架时其直径可设置为5mm至20mm。
此外,外筒体1可采用304不锈钢制成,针座4、支撑管架32和软套8均可采用PP材料制成,采液管31可采用PET材料制成,管塞33和环形限位件37均可采用橡胶制成。
在一些实施例中,穿刺针2的总长度为或约为35mm,从针座4向外伸出的伸出长度为或约为6mm,从针座4向内伸出的伸出长度为或约为15mm,位于针座4中的部分的长度为或约为14mm;穿刺针2的外径设置为0.5mm(25G);穿刺针2的针尖斜角设置为17°±2°;设有管塞33的采液管31容积设置为8μL至310μL,且采液管内气压范围设置为8mmHg至40mmHg之间。
在一些实施例中,本发明提供了一种从角膜收集房水的方法,包括:
将上述的房水采集装置的穿刺针2的穿刺针外端刺入眼睛的前房;
推动采液管组件3的后端以使得采液管组件3中的采液管31朝向穿刺针2的穿刺针内端移动,以使穿刺针内端穿过管塞33进入采液管31;
使前房的房水在眼内压和负压之间的压差下穿过穿刺针2并流入采液管31;
从前房拉出房水采集装置;和
从外筒体1中取出采液管组件3。
在一些实施例中,推动采液管组件3的后端的步骤可包括:
用单手握住房水采集装置,并用食指推动采液管组件3的后端。
在一些实施例中,前房的房水在眼内压和采液管31内负压之间的压差下穿过穿刺针2并流入采液管31可持续或持续约1s、2s、3s、4s、5s、6s、7s、8s、9s、10s、11s、12s、13s、14s、15s、16s、17s、18s、19s、20s、21s、22s、23s、24s、25s、26s、27s、28s、29s、30s或更长时间。
在一些实施例中,从外筒体1中取出采液管组件3步骤可包括:不对采液管组件施加外力,或停止或减少对采液管组件施加外力,允许采液管组件回弹。可选地,采液管组件3能够自然弹出,而无须施加外力专门拔出采液管组件。
在一些实施例中,本发明提供了一种用于从受试者的眼睛收集房水的方法,包括:
将上述的房水采集装置的穿刺针2的穿刺针外端刺入眼睛的前房,其中,采液管31内的压力低于受试者的眼内压;
推动采液管组件3的后端以使得采液管组件3中的采液管31朝向穿刺针2的穿刺针内端移动,以使穿刺针内端穿过管塞33进入采液管31;
使眼前房的房水在眼内压和负压之间的压差下穿过穿刺针2并流入采液管31;
从前房拉出房水采集装置;和
从外筒体1中取出采液管组件3。
在一些实施例中,推动采液管组件3的后端的步骤可包括:
用单手握住房水采集装置,并用食指推动采液管组件3的后端。
在一些实施例中,前房的房水在眼内压和采液管31内负压之间的压差下穿过穿刺针2并流入采液管31可持续或持续约1s、2s、3s、4s、5s、6s、7s、8s、9s、10s、11s、12s、13s、14s、15s、16s、17s、18s、19s、20s、21s、22s、23s、24s、25s、26s、27s、28s、29s、30s或更长时间。
在一些实施例中,从外筒体1中取出采液管组件3步骤可包括:不对采液管组件施加外力,或停止或减少对采液管组件施加外力,允许采液管组件回弹。可选地,采液管组件3能够自然弹出,而无须施加外力专门拔出采液管组件。
在一些实施例中,本发明提供了一种用于从受试者的眼睛收集房水的方法,包括:
将上述的房水采集装置的穿刺针2的穿刺针外端刺入眼睛的前房,其中,采液管31内的压力为8-40mmHg之间且低于受试者的眼内压;
用单手握住房水采集装置,并用食指推动采液管组件3的后端以使得采液管组件3中的采液管31朝向穿刺针2的穿刺针内端移动,以使穿刺针内端穿过管塞33进入采液管31;
使眼前房的房水在眼内压和负压之间的压差下穿过穿刺针2并流入采液管31,此步骤可持续或持续约1s、2s、3s、4s、5s、6s、7s、8s、9s、10s、11s、12s、13s、14s、15s、16s、17s、18s、19s、20s、21s、22s、23s、24s、25s、26s、27s、28s、29s或30s;
从前房拉出房水采集装置;
停止或减少对采液管组件施加外力,允许采液管组件回弹;和
从外筒体1中取出采液管组件3。
在一些实施例中,该方法还可进一步包括选择采液管31内部的负压,负压低于受试者的眼睛的眼内压。可选地,受试者的眼内压为7mmHg至50mmHg之间,例如7mmHg至10mmHg,10mmHg至20mmHg,20mmHg至30mmHg,30mmHg至40mmHg或40mmHg至50mmHg。可选地,设有管塞33的采液管31(即负压的采液管31)内气压范围可设置为8mmHg至40mmHg之间,例如8mmHg至10mmHg,10mmHg至15mmHg,15mmHg至20mmHg,20mmHg至25mmHg,25mmHg至30mmHg,30mmHg至35mmHg或35mmHg至40mmHg。可选地,设有管塞33的采液管31(即负压的采液管31)内气压范围比受试者的眼内压低约0.5mmHg、1mmHg、2mmHg、3mmHg、4mmHg、5mmHg、6mmHg、7mmHg、8mmHg、9mmHg或10mmHg。
在一些实施例中,本发明提供了一种组装上述的房水采集装置的方法。可选地,该组装方法包括在负压箱中将管塞33与采液管31组装,以在采液管管腔内设置负压。可选地,负压箱内的负压可以调节,以装配不同负压值的采液管。例如,上述的房水采集装置可设置不同型号,对应不同的采液管负压值。根据受试者眼压,可选取合适的采液管负压值以安全可靠地采集房水。
下面将展示采用本发明的房水采集装置的动物试验过程,以更直观地体现房水采集装置的技术效果。
1、试验目的
评价本发明的房水采集装置是否具有安全性、准确性、便捷性和操作效率高等优点。
2、试验动物及分组
本动物试验以新西兰白兔为试验动物,共纳入20只体重在2.1kg~2.6kg且无眼部异常的新西兰白兔。此外,采用常用的25G 1ml结核菌素注射器(厂商规格见表1,下文中简称为“1ml注射器”)作为对比例。
在试验中,将兔子按1:1比例随机分为第1组和第2组,每组各10只。考虑到左右手操作对前房穿刺术的影响,在第1组中,用房水采集装置采集右眼的前房水,用1ml注射器采集左眼的前房水,均用右手进行穿刺操作。在第2组中,用房水采集装置采集左眼的前房水,用1ml注射器采集右眼的前房水,均用左手进行穿刺操作。
此外,本试验中的所有操作均由具有丰富的前房穿刺术和前房水采集经验的同一个实验操作人员完成。
3、产品信息
表1
Figure PCTCN2020096860-appb-000001
4、穿刺操作和术后评估
通过肌肉注射盐酸赛拉嗪注射液(陆眠宁)麻醉兔子,并在穿刺过程中将其侧卧。在手术前5分钟进行局部麻醉,双眼点1次盐酸奥布卡因滴眼液(倍诺喜)。在穿刺过程中,使兔子处于侧卧位,从距离角膜缘约1mm~2mm的角膜进针,保持针头与虹膜平面平行,应注意避免晶状体前囊。
其中,房水采集装置用单手按照上述房水采集方法行前房穿刺和前房水采集。1ml注射器则用一手握持穿刺进入前房,随后用另一手缓慢拉动针栓,使房水逐渐抽吸入注射器,然后将房水转移到微量离心管中。
为了增加这两个操作的可比性,将1ml注射器组与房水采集装置组的目标抽取体积设定为一致,且均设定为50ul。实验中用秒表记录从开始穿刺到前房水收集完成整个操作过程的耗时。
各组采集前房水的体积的测量和计算方法如下:
穿刺操作前,用精密天平称量采液管31(房水采集装置的内部部件)或微量离心管(对应于1ml注射器抽取房水的方法)的净重m1(mg),穿刺后测量含前房水的采液管31或微量离心管的重量m2(mg),所采集的前房水的重量m=m2-m1(mg)。将房水的净重m(mg)除以其近似密度1.0mg/μl得到所采集的前房水的体积(μl)。
手术后立即在裂隙灯下评估前房,并用Seidel试验检测穿刺口处房水的渗漏情况。术后7天再次用裂隙灯检查前节。
5、统计方法
统计分析采用SPSS 22.0版(IBM公司,美国)。T检验和配对t检验分别用于比较独立变量和 配对变量。P<0.05认为有统计学差异。
6、试验结果
6.1一般性评价
在20只新西兰白兔中,第1组的一只兔子在穿刺时出现意外动作,第2组的一只兔子在麻醉时死亡,因此只有18只兔子(36只眼)进行术后观察及统计。18只兔子在术后7天行为活动、摄食量均正常,精神状态尚可,未见明显眼部充血、分泌物增多等不良反应。
6.2安全有效性评价
36只眼根据采用的器械和穿刺时操作手的不同分为以下四个亚组:CR组:房水采集装置-右手操作组;CL组:房水采集装置-左手操作组;SR组:1ml注射器-右手操作组;SL组:1ml注射器-左手操作组。下文从前房水采集量、操作时间、前节检查、切口闭合情况等方面评价各亚组之间的安全性和有效性。
6.2.1采集的前房水体积(aqueous humor volume)
表2各组前房水采集量
分组 范围(μL) 平均值±标准差(μL)
CR 39.20-50.40 46.66±3.37
CL 45.00-53.60 48.71±2.88
SR 64.00-123.50 85.11±18.7
SL 36.80-115.80 80.68±20.87
各组所采集的前房水体积见表2和图29。其中,CR或collector(R)表示房水采集装置-右手操作组,CL或collector(L)表示房水采集装置-左手操作组,SR或syringe(R)表示1ml注射器-右手操作组,SL或syringe(L)表示1ml注射器-左手操作组。
CR组和CL组的目标采集量(50ul)偏差绝对值(ADTV)分别为3.43±3.27(范围0.40至10.80)ul和2.51±1.75(范围0.20至5.00)μl。
SR组和SL组的目标采集量(50ul)偏差绝对值(ADTV)分别为35.11±18.70ul(范围14.00至73.50)ul和33.61±14.95(范围13.20至65.80)μl之间。
两个房水采集装置亚组(CR和CL组)的ADTV显著低于两个1ml注射器亚组(SR和SL组)。但房水采集装置两亚组之间、1ml注射器两亚组之间没有统计学差异(P>0.05)。
6.2.2操作时间(operation time)
表3各亚组的操作时间
分组 范围(s) 平均值±标准差(s)
CR 10.89-17.67 14.41±2.06
CL 12.45-18.83 15.53±2.13
SR 17.23-23.57 20.16±2.46
SL 17.23-25.95 20.11±2.79
各亚组的操作时间见表3和图30。其中,CR或collector(R)表示房水采集装置-右手操作组,CL或collector(L)表示房水采集装置-左手操作组,SR或syringe(R)表示1ml注射器-右手操作组,SL或syringe(L)表示1ml注射器-左手操作组。
如图30所示,应用房水采集装置的两个亚组的操作时间较1ml注射器的两个亚组用时短,差异有统计学意义(P<0.01),但左手和右手操作亚组之间均没有统计学差异(P>0.05)。
前房穿刺术后立即行眼前节检查可以看到不同程度的虹膜充血和前房闪辉,但在术后一周基本消退(参见图31)。穿刺术后立即行Seidel试验显示所有受试眼的穿刺口闭合良好,无前房水渗漏(参见图31)。
参照图31,兔子在前房穿刺后立即行前节检查,可以发现双眼虹膜充血(A,F)和前房闪辉(B,G)。Seidel试验显示穿刺口无前房水渗漏(C,H)。虹膜充血(D,I)和前房闪辉(E,J)在穿刺术后一周均完全消退。注意该兔子左眼是用1ml注射器抽取房水(A至E),而右眼是由房水采 集装置抽取房水(F至J)。
7、结论
与以前的基于注射器和移液管的技术相比,本试验采用的一次性使用前房穿刺器(即本发明的房水采集装置)具有许多实质性的优势。
第一,只需用单手进行一系列简单的操作即可轻松完成完整的前房穿刺和前房水采样过程。第二,首次实现了前房水的精确采样。第三,操作者在采样过程中无需注意所采集标本的体积,也不必集中注意力精细控制给移液管施加的压力或拉动针栓的力量,而可以把所有注意力集中在被操作的眼上。第四,操作过程中另一只手可以帮助稳定患者的头部或辅助固定眼球。这些设计极大地提高了房水采集的安全性,减少了对患者配合度的依赖,实现在有或没有裂隙灯的帮助下在门诊环境中完成操作。第五个优点是采集前房水后无需转移标本,因为房水采集装置的采液管31本身就是微量离心管。此功能还有助于避免在转移过程中损失标本、提高了操作效率,避免标本受污染。
在所有试验眼中均未观察到有房水渗漏和前房塌陷的情况。和以前的研究一样,在前房穿刺术后,四个亚组均观察到了不同程度的虹膜充血和房水闪辉,但在1周时均消退。以上结果表明一次性使用前房穿刺器和传统的注射器采样方法均非常安全。
综上,此动物试验证实新型的一次性使用前房穿刺器实现了单手操作和前房水精准定量采集,相比传统使用注射器的前房水采样方法,具有更高的安全性和精准性。
在本申请实施例中,提供一种房水采集装置,包括:
外筒体,设有位于轴向两端的穿刺针安装端和采液管安装端;
穿刺针,固定安装于穿刺针安装端且设有位于外筒体筒腔内的穿刺针内端和位于外筒体筒腔外的穿刺针外端;
采液管组件,包括从采液管安装端插入至外筒体筒腔内且能够沿轴向插拔移动的采液管和设置在外筒体筒腔内以用于密封采液管管口的管塞;
其中,管塞与外筒体内周壁之间的静摩擦系数为μ1,管塞与采液管管口之间的静摩擦系数为μ2,且满足:μ1<μ2;
或者,管塞间隔于外筒体内周壁设置。
在本申请实施例中,管塞与外筒体内周壁之间形成光滑接触。
在本申请实施例中,房水采集装置还包括用于限位采液管组件沿外筒体筒腔径向位移的防晃动结构。
在本申请实施例中防晃动结构包括形成在采液管组件的外周壁上的环形凹槽和环箍环形凹槽设置的环形限位件,环形限位件的径向外端抵接外筒体内周壁。
在本申请实施例中环形限位件为橡皮圈。
在本申请实施例中环形凹槽的凹槽侧壁形成有沿外筒体筒腔的轴向贯通的凹槽通气孔,外筒体筒腔在管塞与穿刺针安装端之间的筒腔区域连通凹槽通气孔。
在本申请实施例中房水采集装置还包括用于固定安装穿刺针的针座,针座的针座内端与穿刺针安装端之间形成快速插拔连接。
在本申请实施例中针座内端与穿刺针安装端之间形成螺纹插接或卡扣插接。
在本申请实施例中房水采集装置还包括用于沿外筒体筒腔的轴向隔离穿刺针内端与管塞的防刺破隔离件,该防刺破隔离件为可拆卸件。
在本申请实施例中外筒体的周壁设有隔离件插装槽,外筒体筒腔在穿刺针内端与管塞之间的筒腔区域连通隔离件插装槽,防刺破隔离件通过隔离件插装槽插入至筒腔区域内。
在本申请实施例中,提供一种房水采集装置,包括:
外筒体,包括穿刺针安装端和采液管安装端;
穿刺针,固定安装于穿刺针安装端,穿刺针包括分别从穿刺针安装端的轴向两侧伸出的穿刺针内端和穿刺针外端;
采液管组件,包括从采液管安装端插入至外筒体筒腔内且能够沿轴向插拔移动的采液管和设置在外筒体筒腔内以用于密封采液管管口的管塞;
其中,管塞与外筒体筒腔同轴设置且管塞的半径小于外筒体内周壁的半径,采液管组件的外周壁设有环形凹槽和环箍环形凹槽设置的环形限位件,环形限位件的径向外端抵接外筒体内周壁。
在本申请实施例中,管塞的径向外端与外筒体内周壁的径向间距不小于1mm。
在本申请实施例中,采液管组件包括支撑管架,采液管插装在支撑管架的管架内腔中,环形凹槽设置在支撑管架的外周壁上。
在本申请实施例中,采液管与支撑管架之间形成螺纹连接或卡扣连接。
在本申请实施例中,环形凹槽的凹槽侧壁形成有沿外筒体筒腔的轴向贯通的凹槽通气孔,外筒体筒腔在管塞与穿刺针安装端之间的筒腔区域连通凹槽通气孔。
在本申请实施例中,环形限位件为弹性件。
在本申请实施例中,房水采集装置还包括用于固定安装穿刺针的针座,针座的针座内端与穿刺针安装端之间形成快速插拔连接。
在本申请实施例中,针座内端与穿刺针安装端之间形成螺纹插接或卡扣插接。
在本申请实施例中,房水采集装置还包括用于沿外筒体筒腔的轴向隔离穿刺针内端与管塞的防刺破隔离件,该防刺破隔离件为可拆卸件。
在本申请实施例中,外筒体的周壁设有隔离件插装槽,外筒体筒腔在穿刺针内端与管塞之间的筒腔区域连通隔离件插装槽,防刺破隔离件通过隔离件插装槽插入至筒腔区域内。
在本申请实施例中,提供一种房水采集装置,包括:
外筒体,包括穿刺针安装端和采液管安装端;
穿刺针,固定安装于穿刺针安装端且设有位于外筒体筒腔内的穿刺针内端和位于外筒体筒腔外的穿刺针外端;
采液管组件,包括从采液管安装端插入至外筒体筒腔内且能够沿轴向插拔移动的采液管和设置在外筒体筒腔内以用于密封采液管管口的管塞;
其中,采液管组件的外周壁设有环形凹槽和环箍环形凹槽设置的环形限位件,环形限位件的径向外端抵接外筒体内周壁,管塞的径向外缘部与外筒体内周壁之间形成光滑接触并设有沿外筒体筒腔的延伸方向设置的管塞排气通道,外筒体筒腔在管塞与穿刺针安装端之间的筒腔区域连通管塞排气通道。
在本申请实施例中,管塞设有沿外筒体筒腔的轴向延伸且沿管塞的周向依次间隔排布的多个管塞排气通道。
在本申请实施例中,管塞的外周壁上形成有作为管塞排气通道的管塞排气凹槽,该管塞排气凹槽设有朝向径向外侧的凹槽开口。
在本申请实施例中,管塞排气通道的通道周壁为封闭周壁。
在本申请实施例中,管塞排气通道的横截面呈半圆形形状、方形形状或弧形形状。
在本申请实施例中,管塞包括用于密封采液管管口的管塞中心部和位于管塞中心部的径向外侧且设有管塞排气通道的管塞外环部,管塞外环部至少部分形成为疏松通气结构。
在本申请实施例中,管塞的端部设有用于引导穿刺针内端穿入的刺破导盲孔,穿刺针内端的外轮廓形状与刺破导盲孔的形状相互匹配。
在本申请实施例中,采液管与外筒体内周壁之间设有周壁排气间隙,外筒体筒腔在管塞与穿刺针安装端之间的筒腔区域、管塞排气通道和周壁排气间隙依次连通。
在本申请实施例中,穿刺针内端的外周壁上设有与穿刺针的针腔连通的周壁出水孔。
在本申请实施例中,穿刺针内端还设有与针腔沿轴向连通的轴向出水孔,周壁出水孔的孔中心与轴向出水孔的孔中心的轴向间距为不大于3mm。
在本申请实施例中,提供一种房水采集装置,包括:
外筒体,包括穿刺针安装端和采液管安装端;
穿刺针,固定安装于穿刺针安装端且设有位于外筒体筒腔内的穿刺针内端和位于外筒体筒腔外的穿刺针外端;
采液管,从采液管安装端插入至外筒体筒腔内且能够沿轴向插拔移动;
管塞,设置在外筒体筒腔内且用于密封采液管管口,管塞的径向外缘部设有沿外筒体筒腔的延伸方向设置的管塞排气通道,该管塞排气通道连通外筒体筒腔在管塞与穿刺针安装端之间的筒腔区域。
在本申请实施例中,管塞设有沿外筒体筒腔的轴向延伸且沿管塞的周向依次间隔排布的多个管塞排气通道。
在本申请实施例中,管塞的外周壁上形成有作为管塞排气通道的管塞排气凹槽,该管塞排气凹槽设有朝向径向外侧的凹槽开口。
在本申请实施例中,管塞排气通道的通道周壁为封闭周壁。
在本申请实施例中,管塞排气通道的横截面呈半圆形形状、方形形状或弧形形状。
在本申请实施例中,管塞包括用于密封采液管管口的管塞中心部和位于管塞中心部的径向外侧且设有管塞排气通道的管塞外环部,管塞外环部至少部分形成为疏松通气结构。
在本申请实施例中,管塞的端部设有用于引导穿刺针内端穿入的刺破导盲孔,穿刺针内端的外轮廓形状与刺破导盲孔的形状相互匹配。
在本申请实施例中,采液管与外筒体内周壁之间设有周壁排气间隙,外筒体筒腔在管塞与穿刺针安装端之间的筒腔区域、管塞排气通道和周壁排气间隙依次连通。
在本申请实施例中,提供一种房水采集装置,包括外筒体、穿刺针和采液管组件,外筒体设有穿刺针安装端和采液管安装端,穿刺针插装在穿刺针安装端中且包括穿刺针外端和插装至外筒体筒腔内的穿刺针内端,采液管组件从采液管安装端插入至外筒体筒腔内且包括可插拔移动的采液管和用于密封外筒体筒腔内的采液管管口的管塞;其中,房水采集装置还包括用于限位采液管组件沿外筒体筒腔径向位移的防晃动结构。
在本申请实施例中,采液管组件还包括支撑管架,采液管插装在支撑管架的管架内腔中,防晃动结构包括从支撑管架的外周壁或从外筒体内周壁凸出的限位凸起,该限位凸起的径向两端分别连接支撑管架的外周壁和外筒体内周壁。
在本申请实施例中,采液管与支撑管架之间通过螺接固定或卡扣连接固定。
在本申请实施例中,限位凸起一体成型在支撑管架的外周壁上;或者,采液管组件包括外套在支撑管架的外周壁上的管套件,限位凸起设置在管套件的外周壁上。
在本申请实施例中,管套件为弹性管套件。
在本申请实施例中,防晃动结构包括沿周向依次间隔排布的多个限位凸起;
或者,防晃动结构包括沿周向连续延伸成型的限位凸起,限位凸起与支撑管架的外周壁之间或限位凸起与外筒体内周壁之间形成有排气间隙。
在本申请实施例中,沿周向依次间隔排布的多个限位凸起均呈凸点状。
在本申请实施例中,沿周向连续延伸成型的限位凸起呈波纹状或斜齿状。
在本申请实施例中,提供一种房水采集装置,包括:
外筒体,设有穿刺针安装端和采液管安装端;
穿刺针,插装在穿刺针安装端中且包括穿刺针外端和伸入至外筒体筒腔内的穿刺针内端;
采液管组件,可插拔移动地从采液管安装端插入至外筒体筒腔内且包括采液管和用于密封在外筒体筒腔内的采液管管口的管塞;
其中,采液管组件与外筒体内周壁之间形成有通气结构,该通气结构连通外筒体筒腔在穿刺针内端与管塞之间的筒腔区域,房水采集装置还包括用于限位采液管组件沿径向位移且用于在采液管组件与外筒体内周壁之间形成接触阻尼的限位缓冲结构。
在本申请实施例中,限位缓冲结构包括从采液管组件的外周壁或从外筒体内周壁凸出的限位凸起,该限位凸起的径向两端分别连接采液管组件的外周壁和外筒体内周壁。
在本申请实施例中,限位缓冲结构包括沿采液管组件的管长方向依次间隔设置或者沿管长方向连续延伸的限位凸起,限位凸起沿管长方向的总跨度不小于采液管管长的一半。
在本申请实施例中,限位凸起一体成型在采液管的外周壁上;或者,采液管组件包括外套在采液管的外周壁上的管套件,限位凸起设置在管套件的外周壁上。
在本申请实施例中,管套件为弹性管套件。
在本申请实施例中,限位缓冲结构包括沿周向依次间隔排布的多个限位凸起,多个限位凸起之间的间隙形成为通气结构;
或者,限位缓冲结构包括沿周向连续延伸成型的限位凸起,限位凸起与采液管组件的外周壁之间或限位凸起与外筒体内周壁之间形成有作为通气结构的排气间隙。
在本申请实施例中,沿周向依次间隔排布的多个限位凸起均呈凸点状。
在本申请实施例中,沿周向连续延伸成型的限位凸起呈波纹状或斜齿状。
在本申请实施例中,采液管组件还包括用于固定安装采液管的支撑管架,该支撑管架的外周 壁与外筒体内周壁之间形成有限位缓冲结构。
在本申请实施例中,采液管与支撑管架之间通过螺接固定或卡扣连接固定。
在本申请实施例中,一种房水采集装置,包括:
外筒体,设有位于轴向两端的穿刺针安装端和采液管安装端;
穿刺针,固定安装于穿刺针安装端且设有位于外筒体筒腔内的穿刺针内端和位于外筒体筒腔外的穿刺针外端;
采液管组件,包括从采液管安装端插入至外筒体筒腔内且能够沿轴向插拔移动的采液管和设置在外筒体筒腔内以用于密封采液管管口的管塞;
其中,管塞与外筒体内周壁之间的静摩擦系数为μ1,管塞与采液管管口之间的静摩擦系数为μ2,且满足:μ1<μ2;
或者,管塞间隔于外筒体内周壁设置。
在本申请实施例中,管塞与外筒体内周壁之间形成光滑接触。
在本申请实施例中,房水采集装置还包括用于限位采液管组件沿外筒体筒腔径向位移的防晃动结构。
在本申请实施例中,防晃动结构包括形成在采液管组件的外周壁上的环形凹槽和环箍环形凹槽设置的环形限位件,环形限位件的径向外端抵接外筒体内周壁。
在本申请实施例中,环形凹槽的凹槽侧壁形成有沿外筒体筒腔的轴向贯通的凹槽通气孔,外筒体筒腔在管塞与穿刺针安装端之间的筒腔区域连通凹槽通气孔。
在本申请实施例中,采液管组件包括支撑管架,采液管插装在支撑管架的管架内腔中,环形凹槽设置在支撑管架的外周壁上。
在本申请实施例中,采液管组件还包括支撑管架,采液管插装在支撑管架的管架内腔中,防晃动结构包括从支撑管架的外周壁或从外筒体内周壁凸出的限位凸起,该限位凸起的径向两端分别连接支撑管架的外周壁和外筒体内周壁。
在本申请实施例中,房水采集装置还包括用于固定安装穿刺针的针座,针座的针座内端与穿刺针安装端之间形成快速插拔连接。
在本申请实施例中,房水采集装置还包括用于沿外筒体筒腔的轴向隔离穿刺针内端与管塞的防刺破隔离件,该防刺破隔离件为可拆卸件。
在本申请实施例中,外筒体的周壁设有隔离件插装槽,外筒体筒腔在穿刺针内端与管塞之间的筒腔区域连通隔离件插装槽,防刺破隔离件通过隔离件插装槽插入至筒腔区域内。
在本申请实施例中,提供一种从角膜收集房水的方法,包括:
将上述的房水采集装置的穿刺针的穿刺针外端刺入眼睛的前房;
推动采液管组件的后端以使得采液管组件中的采液管朝向穿刺针的穿刺针内端移动,以使穿刺针内端穿过管塞进入采液管;
使前房的房水在眼内压和采液管之间的压差下穿过穿刺针并流入采液管;
从前房拉出房水采集装置;和
从外筒体中取出采液管组件。
在本申请实施例中,方法包括:推动采液管组件的后端以使得采液管组件中的采液管朝向穿刺针的穿刺针内端移动,以使穿刺针内端穿过管塞进入采液管包括:
用单手握住房水采集装置,并用食指轻推采液管组件的后端。
在本申请实施例中,提供一种用于从受试者的眼睛收集房水的方法,包括:
将上述的房水采集装置的穿刺针的穿刺针外端刺入眼睛的前房,其中,采液管内的压力低于受试者的眼内压;
推动采液管组件的后端以使得采液管组件中的采液管朝向穿刺针的穿刺针内端移动,以使穿刺针内端穿过管塞进入采液管;
使眼前房的房水在眼内压和负压之间的压差下穿过穿刺针并流入采液管;
从前房拉出房水采集装置;和
从外筒体中取出采液管组件。
在本申请实施例中,方法包括:推动采液管组件的后端以使得采液管组件中的采液管朝向穿刺针的穿刺针内端移动,以使穿刺针内端穿过管塞进入采液管包括:
用单手握住房水采集装置,并用食指轻推采液管组件的后端。
在本申请实施例中,方法包括:选择采液管内部的负压,负压低于受试者的眼睛的眼内压。
在本申请实施例中,提供一种试剂支架,包括支架本体和设置在支架本体上的功能位,功能位包括盛液管插装孔和弹性部件,弹性部件设置为:在盛液管插装孔内插装有盛液管的情况下,能够弹性作用于盛液管,以使得盛液管能够沿盛液管插装孔的孔中心轴线方向弹性移动。
在本申请实施例中,功能位还包括功能位外套筒,功能位外套筒从盛液管插装孔的内周壁沿孔中心轴线方向向下伸出,弹性部件位于功能位外套筒的套筒内腔。
在本申请实施例中,弹性部件为弹簧机构或弹性介质。
在本申请实施例中,弹簧机构位于套筒内腔的底部且能够沿孔中心轴线方向弹性移动,在弹簧机构的弹性移动过程中,弹簧机构的外周部至少部分贴合套筒内腔的内周壁滑移。
在本申请实施例中,弹性部件位于套筒内腔的底部,弹性部件的顶部中心形成有用于支撑盛液管的底部的支撑凹位。
在本申请实施例中,试剂支架为条形支架。
在本申请实施例中,功能位包括样本位、试剂位、测光位、反应位或预留位。
在本申请实施例中,提供一种检测设备总成,包括检测设备、盛液管和根据权利要求1~7中任意一项的试剂支架,盛液管可拆卸地插装在盛液管插装孔内,检测设备包括取液装置,取液装置设置为用于伸入盛液管的管腔内取液。
在本申请实施例中,检测设备设置为在取液装置受到刚性碰撞时制停。
在本申请实施例中,功能位还包括功能位外套筒,功能位外套筒从盛液管插装孔的内周壁沿孔中心轴线方向向下伸出,盛液管的底部外轮廓呈倒锥形,盛液管穿过盛液管插装孔以插入至功能位外套筒的套筒内腔且盛液管的顶端不高于盛液管插装孔的孔口,盛液管的管口外径与套筒内腔的内径相同。
在本申请实施例中,提供一种检测设备总成,包括:
试剂支架,设有支架本体和设置在支架本体上的功能位,功能位包括盛液管插装孔和弹性部件;
盛液管,可拆卸地插装于盛液管插装孔内,盛液管能够受到弹性部件的弹性作用以沿盛液管插装孔的孔中心轴线方向弹性移动;
检测设备,设有用于伸入盛液管的管腔内取液的取液针,取液针的外端面形成为倾斜端面且倾斜端面上形成有取液口。
在本申请实施例中,取液针沿直线延伸且包括相互连接的针身段和针头段,针头段的外端形成有取液口,针身段的针身段中心轴线与取液口的取液口中心轴线相交。
在本申请实施例中,针身段中心轴线与取液口中心轴线相交形成的锐角夹角为α,且α满足:0<α≤0.1°。
在本申请实施例中,倾斜端面为曲面或平面。
在本申请实施例中,盛液管的管腔内底壁为平面壁或曲面壁。
在本申请实施例中,检测设备设置为在取液针受到刚性碰撞时制停。
在本申请实施例中,功能位还包括功能位外套筒,功能位外套筒从盛液管插装孔的内周壁沿孔中心轴线方向向下伸出,弹性部件位于功能位外套筒的套筒内腔。
在本申请实施例中,弹性部件为弹簧机构或弹性介质。
在本申请实施例中,弹性部件位于套筒内腔的底部,弹性部件的顶部中心形成有用于支撑盛液管的底部的支撑凹位,盛液管的底部外轮廓呈倒锥形,支撑凹位的形状匹配于盛液管的底部外轮廓。
在本申请实施例中,功能位为样本位、试剂位、测光位、反应位或预留位。
在本申请实施例中,提供一种试剂支架,包括支架本体和设置在支架本体上的功能位,功能位包括盛液管插装孔和弹性部件,弹性部件设置为:在盛液管插装孔内插装有盛液管的情况下,能够弹性作用于盛液管,以使得盛液管能够沿盛液管插装孔的孔中心轴线方向弹性移动。
在本申请实施例中,功能位还包括功能位外套筒,功能位外套筒从盛液管插装孔的内周壁沿孔中心轴线方向向下伸出,弹性部件位于功能位外套筒的套筒内腔。
在本申请实施例中,弹性部件为弹簧机构或弹性介质。
在本申请实施例中,弹簧机构位于套筒内腔的底部且能够沿孔中心轴线方向弹性移动,在弹簧机构的弹性移动过程中,弹簧机构的外周部至少部分贴合套筒内腔的内周壁滑移。
在本申请实施例中,试剂支架还包括可拆卸地插装于盛液管插装孔内的转换插座,转换插座包括上下连接的支撑套筒部和延伸套筒部,支撑套筒部的套筒腔与延伸套筒部的套筒腔上下连通且共同形成为转换插装腔,转换插装腔用于供盛液管可拆卸地插入。
在本申请实施例中,功能位包括样本位、试剂位、测光位、反应位或预留位。
在本申请实施例中,提供一种检测设备总成,包括检测设备、盛液管和上述的试剂支架,盛液管可拆卸地插装在盛液管插装孔内,检测设备包括取液装置,取液装置设置为用于伸入盛液管的管腔内取液。
在本申请实施例中,检测设备设置为在取液装置受到刚性碰撞时制停。
在本申请实施例中,功能位还包括功能位外套筒,功能位外套筒从盛液管插装孔的内周壁沿孔中心轴线方向向下伸出,盛液管的底部外轮廓呈倒锥形,盛液管穿过盛液管插装孔以插入至功能位外套筒的套筒内腔且盛液管的顶端不高于盛液管插装孔的孔口,盛液管的管口外径与套筒内腔的内径相同。
在本申请实施例中,取液装置设有用于伸入盛液管的管腔内取液的取液针,取液针的外端面形成为倾斜端面且倾斜端面上形成有取液口。
在本申请实施例中,提供一种房水采集装置,包括:
外筒体,设有位于轴向两端的穿刺针安装端和采液管安装端;
穿刺针,固定安装于穿刺针安装端且设有位于外筒体筒腔内的穿刺针内端和位于外筒体筒腔外的穿刺针外端;
采液管组件,包括从采液管安装端插入至外筒体筒腔内且能够沿轴向插拔移动的采液管和设置在外筒体筒腔内以用于密封采液管管口的管塞;
其中,管塞与外筒体内周壁之间的静摩擦系数为μ1,管塞与采液管管口之间的静摩擦系数为μ2,且满足:μ1<μ2;
或者,管塞间隔于外筒体内周壁设置。
在本申请实施例中,管塞与外筒体内周壁之间形成光滑接触。
在本申请实施例中,房水采集装置还包括用于限位采液管组件沿外筒体筒腔径向位移的防晃动结构。
在本申请实施例中,防晃动结构包括形成在采液管组件的外周壁上的环形凹槽和环箍环形凹槽设置的环形限位件,环形限位件的径向外端抵接外筒体内周壁。
在本申请实施例中,环形凹槽的凹槽侧壁形成有沿外筒体筒腔的轴向贯通的凹槽通气孔,外筒体筒腔在管塞与穿刺针安装端之间的筒腔区域连通凹槽通气孔。
在本申请实施例中,采液管组件包括支撑管架,采液管插装在支撑管架的管架内腔中,环形凹槽设置在支撑管架的外周壁上。
在本申请实施例中,采液管组件还包括支撑管架,采液管插装在支撑管架的管架内腔中,防晃动结构包括从支撑管架的外周壁或从外筒体内周壁凸出的限位凸起,该限位凸起的径向两端分别连接支撑管架的外周壁和外筒体内周壁。
在本申请实施例中,房水采集装置还包括用于固定安装穿刺针的针座,针座的针座内端与穿刺针安装端之间形成快速插拔连接。
在本申请实施例中,房水采集装置还包括用于沿外筒体筒腔的轴向隔离穿刺针内端与管塞的防刺破隔离件,该防刺破隔离件为可拆卸件。
在本申请实施例中,外筒体的周壁设有隔离件插装槽,外筒体筒腔在穿刺针内端与管塞之间的筒腔区域连通隔离件插装槽,防刺破隔离件通过隔离件插装槽插入至筒腔区域内。
在本申请实施例中,提供一种从角膜收集房水的方法,包括:
将上述的房水采集装置的穿刺针的穿刺针外端刺入眼睛的前房;
推动采液管组件的后端以使得采液管组件中的采液管朝向穿刺针的穿刺针内端移动,以使穿刺针内端穿过管塞进入采液管;
使前房的房水在眼内压和采液管之间的压差下穿过穿刺针并流入采液管;
从前房拉出房水采集装置;和
从外筒体中取出采液管组件。
在本申请实施例中,方法包括:推动采液管组件的后端以使得采液管组件中的采液管朝向穿刺针的穿刺针内端移动,以使穿刺针内端穿过管塞进入采液管包括:
用单手握住房水采集装置,并用食指轻推采液管组件的后端。
在本申请实施例中,提供一种用于从受试者的眼睛收集房水的方法,包括:
将上述的房水采集装置的穿刺针的穿刺针外端刺入眼睛的前房,其中,采液管内的压力低于受试者的眼内压;
推动采液管组件的后端以使得采液管组件中的采液管朝向穿刺针的穿刺针内端移动,以使穿刺针内端穿过管塞进入采液管;
使眼前房的房水在眼内压和负压之间的压差下穿过穿刺针并流入采液管;
从前房拉出房水采集装置;和
从外筒体中取出采液管组件。
在本申请实施例中,方法包括:推动采液管组件的后端以使得采液管组件中的采液管朝向穿刺针的穿刺针内端移动,以使穿刺针内端穿过管塞进入采液管包括:
用单手握住房水采集装置,并用食指轻推采液管组件的后端。
在本申请实施例中,方法包括:选择采液管内部的负压,负压低于受试者的眼睛的眼内压。
以上结合附图详细描述了本发明实施例的可选实施方式,但是,本发明实施例并不限于上述实施方式中的具体细节,在本发明实施例的技术构思范围内,可以对本发明实施例的技术方案进行多种简单变型,这些简单变型均属于本发明实施例的保护范围。
另外需要说明的是,在上述具体实施方式中所描述的各个具体技术特征,在不矛盾的情况下,可以通过任何合适的方式进行组合,为了避免不必要的重复,本发明实施例对各种可能的组合方式不再另行说明。
此外,本发明实施例的各种不同的实施方式之间也可以进行任意组合,只要其不违背本发明实施例的思想,其同样应当视为本发明实施例所公开的内容。

Claims (25)

  1. 一种试剂支架,其特征在于,所述试剂支架(9)包括支架本体和设置在所述支架本体上的功能位,所述功能位包括盛液管插装孔(91)和弹性部件,所述弹性部件设置为:在所述盛液管插装孔(91)内插装有盛液管(106)的情况下,能够弹性作用于所述盛液管(106),以使得所述盛液管(106)能够沿所述盛液管插装孔(91)的孔中心轴线方向弹性移动。
  2. 根据权利要求1所述的试剂支架,其特征在于,所述功能位还包括功能位外套筒(92),所述功能位外套筒(92)从所述盛液管插装孔(91)的内周壁沿所述孔中心轴线方向向下伸出,所述弹性部件位于所述功能位外套筒(92)的套筒内腔。
  3. 根据权利要求2所述的试剂支架,其特征在于,所述弹性部件为弹簧机构(93)或弹性介质。
  4. 根据权利要求3所述的试剂支架,其特征在于,所述弹簧机构(93)位于所述套筒内腔的底部且能够沿所述孔中心轴线方向弹性移动,在所述弹簧机构(93)的弹性移动过程中,所述弹簧机构(93)的外周部至少部分贴合所述套筒内腔的内周壁滑移。
  5. 根据权利要求1所述的试剂支架,其特征在于,所述试剂支架(9)还包括可拆卸地插装于所述盛液管插装孔(91)内的转换插座(914),所述转换插座(914)包括上下连接的支撑套筒部(914a)和延伸套筒部(914b),所述支撑套筒部(914a)的套筒腔与所述延伸套筒部(914b)的套筒腔上下连通且共同形成为转换插装腔,所述转换插装腔用于供盛液管(106)可拆卸地插入。
  6. 根据权利要求1~5中任意一项所述的试剂支架,其特征在于,所述功能位包括样本位(95)、试剂位(98)、测光位(99)、反应位(910)或预留位(912)。
  7. 一种检测设备总成,其特征在于,所述检测设备总成包括检测设备(10)、盛液管(106)和根据权利要求1~6中任意一项所述的试剂支架(9),所述盛液管(106)可拆卸地插装在所述盛液管插装孔(91)内,所述检测设备(10)包括取液装置,所述取液装置设置为用于伸入所述盛液管(106)的管腔内取液。
  8. 根据权利要求7所述的检测设备总成,其特征在于,所述检测设备(10)设置为在所述取液装置受到刚性碰撞时制停。
  9. 根据权利要求7所述的检测设备总成,其特征在于,所述功能位还包括功能位外套筒(92),所述功能位外套筒(92)从所述盛液管插装孔(91)的内周壁沿所述孔中心轴线方向向下伸出,所述盛液管(106)的底部外轮廓呈倒锥形,所述盛液管(106)穿过所述盛液管插装孔(91)以插入至所述功能位外套筒(92)的套筒内腔且所述盛液管(106)的顶端不高于所述盛液管插装孔(91)的孔口,所述盛液管(106)的管口外径与所述套筒内腔的内径相同。
  10. 根据权利要求7所述的检测设备总成,其特征在于,所述取液装置设有用于伸入所述盛液管(106)的管腔内取液的取液针(104),所述取液针(104)的外端面形成为倾斜端面(104a)且所述倾斜端面(104a)上形成有取液口。
  11. 一种房水采集装置,其特征在于,所述房水采集装置包括:
    外筒体(1),设有位于轴向两端的穿刺针安装端和采液管安装端;
    穿刺针(2),固定安装于所述穿刺针安装端且设有位于外筒体筒腔内的穿刺针内端和位于所述外筒体筒腔外的穿刺针外端;
    采液管组件(3),包括从所述采液管安装端插入至所述外筒体筒腔内且能够沿轴向插拔移动的采液管(31)和设置在所述外筒体筒腔内以用于密封采液管管口的管塞(33);
    其中,所述管塞(33)与外筒体内周壁之间的静摩擦系数为μ1,所述管塞(33)与所述采液管管口之间的静摩擦系数为μ2,且满足:μ1<μ2;
    或者,所述管塞(33)间隔于外筒体内周壁设置。
  12. 根据权利要求11所述的房水采集装置,其特征在于,所述管塞(33)与所述外筒体内周壁之间形成光滑接触。
  13. 根据权利要求11所述的房水采集装置,其特征在于,所述房水采集装置还包括用于限位所述采液管组件(3)沿所述外筒体筒腔径向位移的防晃动结构。
  14. 根据权利要求13所述的房水采集装置,其特征在于,所述防晃动结构包括形成在所述采液管组件(3)的外周壁上的环形凹槽(35)和环箍所述环形凹槽(35)设置的环形限位件(37),所述环形限位件(37)的径向外端抵接所述外筒体内周壁。
  15. 根据权利要求14所述的房水采集装置,其特征在于,所述环形凹槽(35)的凹槽侧壁形成有沿所述外筒体筒腔的轴向贯通的凹槽通气孔(36),所述外筒体筒腔在所述管塞(33)与所述穿刺针安装端之间的筒腔区域连通所述凹槽通气孔(36)。
  16. 根据权利要求14所述的房水采集装置,其特征在于,所述采液管组件(3)包括支撑管架(32),所述采液管(31)插装在所述支撑管架(32)的管架内腔中,所述环形凹槽(35)设置在所述支撑管架(32)的外周壁上。
  17. 根据权利要求13所述的房水采集装置,其特征在于,所述采液管组件(3)还包括支撑管架(32),所述采液管(31)插装在所述支撑管架(32)的管架内腔中,所述防晃动结构包括从所述支撑管架(32)的外周壁或从外筒体内周壁凸出的限位凸起(6),该限位凸起(6)的径向两端分别连接所述支撑管架(32)的外周壁和所述外筒体内周壁。
  18. 根据权利要求11所述的房水采集装置,其特征在于,所述房水采集装置还包括用于固定安装所述穿刺针(2)的针座(4),所述针座(4)的针座内端与所述穿刺针安装端之间形成快速插拔连接。
  19. 根据权利要求11至18中任意一项所述的房水采集装置,其特征在于,所述房水采集装置还包括用于沿所述外筒体筒腔的轴向隔离所述穿刺针内端与所述管塞(33)的防刺破隔离件(5),该防刺破隔离件(5)为可拆卸件。
  20. 根据权利要求19所述的房水采集装置,其特征在于,所述外筒体(1)的周壁设有隔离件插装槽(11),所述外筒体筒腔在所述穿刺针内端与所述管塞(33)之间的筒腔区域连通所述隔离件插装槽(11),所述防刺破隔离件(5)通过所述隔离件插装槽(11)插入至所述筒腔区域内。
  21. 一种从角膜收集房水的方法,包括:
    将根据权利要求11至20中任意一项所述的房水采集装置的穿刺针(2)的穿刺针外端刺入眼睛的前房;
    推动采液管组件(3)的后端以使得所述采液管组件(3)中的采液管(31)朝向所述穿刺针(2)的穿刺针内端移动,以使所述穿刺针内端穿过管塞(33)进入所述采液管(31);
    使前房的房水在眼内压和采液管之间的压差下穿过所述穿刺针(2)并流入所述采液管(31);
    从前房拉出所述房水采集装置;和
    从外筒体(1)中取出所述采液管组件(3)。
  22. 根据权利要求21所述的方法,其中,推动采液管组件(3)的后端以使得所述采液管组件(3)中的采液管(31)朝向所述穿刺针(2)的穿刺针内端移动,以使所述穿刺针内端穿过管塞(33)进入所述采液管(31)包括:
    用单手握住所述房水采集装置,并用食指轻推所述采液管组件(3)的后端。
  23. 一种用于从受试者的眼睛收集房水的方法,包括:
    将根据权利要求11至20中任意一项所述的房水采集装置的穿刺针(2)的穿刺针外端刺入眼睛的前房,其中,采液管(31)内的压力低于受试者的眼内压;
    推动采液管组件(3)的后端以使得所述采液管组件(3)中的所述采液管(31)朝向所述穿刺针(2)的穿刺针内端移动,以使所述穿刺针内端穿过管塞(33)进入所述采液管(31);
    使眼前房的房水在眼内压和负压之间的压差下穿过所述穿刺针(2)并流入所述采液管(31);
    从前房拉出所述房水采集装置;和
    从外筒体(1)中取出所述采液管组件(3)。
  24. 根据权利要求23所述的方法,其中,推动采液管组件(3)的后端以使得所述采液管组件(3)中的所述采液管(31)朝向所述穿刺针(2)的穿刺针内端移动,以使所述穿刺针内端穿过管塞(33)进入所述采液管(31)包括:
    用单手握住所述房水采集装置,并用食指轻推所述采液管组件(3)的后端。
  25. 根据权利要求23或24所述的方法,进一步包括选择所述采液管(31)内部的负压,所述负压低于受试者的眼睛的眼内压。
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