WO2021000440A1

WO2021000440A1 - Aqueous humor collection device and aqueous humor collection method

Info

Publication number: WO2021000440A1
Application number: PCT/CN2019/110062
Authority: WO
Inventors: 赵潺; 夏超然; 孙月广
Original assignee: 北京华视诺维医疗科技有限公司
Priority date: 2019-07-02
Filing date: 2019-10-09
Publication date: 2021-01-07

Abstract

An aqueous humor collection device (100) and an aqueous humor collection method. The aqueous humor collection device comprises: an outer cylinder (1) provided with a puncture needle (2) mounting end and a liquid collection pipe (31) mounting end; a puncture needle (2) fixedly mounted at the puncture needle (2) mounting end and provided with a puncture needle (2) inner end located in an outer cylinder (1) cavity and a puncture needle (2) outer end located outside the outer cylinder (1) cavity; a liquid collection pipe assembly (3) comprising a liquid pipe (31) which is inserted into the outer cylinder (1) cavity from the liquid collection pipe (31) mounting end and can be axially plugged and moved and a pipe stopper (33) provided in the outer cylinder (1) cavity to be used for sealing an opening of the liquid collection pipe (31), wherein a static friction coefficient between the pipe stopper (33) and an inner peripheral wall of the outer cylinder (1) is μ1, a static friction coefficient between the pipe stopper (33) and the opening of the liquid collection pipe (31) is μ2, and the relation is satisfied: μ1<μ2; or the pipe stopper (33) is arranged separated from the inner peripheral wall of the outer cylinder (1). The aqueous humor collection device (100) can control the drainage speed of aqueous humor in a puncture process, can avoid the contamination of the aqueous humor after collection is completed and the waste caused by transfer of the aqueous humor, and has high safety and reliability.

Description

Aqueous humor collection device and aqueous humor collection method

Technical field

The invention relates to the technical field of medical appliances.

Background technique

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.

At present, there is no unified special equipment and consumables for the implementation of anterior chamber puncture. In actual clinical work, 1ml syringe needles are often used as anterior chamber puncture needles. But in the process of puncturing with the 1ml syringe needle, the drainage speed of aqueous humor is difficult to control. When the fluid is discharged too fast, it will cause a rapid drop in intraocular pressure, and even more serious complications may even cause other complications. In addition, since the aqueous humor in the syringe cavity is further transferred to the microcentrifuge tube after the aqueous humor is collected, the aqueous humor will be wasted during this process, and the aqueous humor will be affected by the external environment during the transfer process. Risk of contamination due to contact, resulting in deviations in test results and poor reliability.

It can be seen that there is an urgent need to develop a new collection device that can solve the problems of poor safety and reliability during the anterior chamber puncture.

Summary of the invention

In view of the above-mentioned shortcomings or deficiencies of the prior art, the present invention provides an aqueous humor collection device and aqueous humor collection method, which can control the drainage speed of aqueous humor during the puncture process, and can prevent the aqueous humor from being polluted after collection. Waste due to transfer, thereby improving safety and reliability.

To achieve the above objective, the first aspect of 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;

Wherein, the static friction coefficient between the pipe plug and the inner peripheral wall of the outer cylinder is μ1, and the static friction coefficient between the pipe plug and the nozzle of the liquid collection tube is μ2, and satisfies: μ1<μ2;

Alternatively, the pipe plug is arranged at intervals on the inner peripheral wall of the outer cylinder.

Optionally, smooth contact is formed between the pipe plug and the inner peripheral wall of the outer cylinder.

Optionally, 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.

Optionally, 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.

Optionally, 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.

Optionally, 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.

Optionally, 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.

Optionally, 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.

Optionally, 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.

Optionally, 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 second aspect of the present invention provides a method for collecting aqueous humor from the cornea, including:

Pierce the outer end of the puncture needle of the aforementioned aqueous humor collection device into the anterior chamber of the eye;

Push the rear end of the liquid sampling tube assembly to move the liquid sampling tube in the liquid sampling tube assembly toward the inner end of the puncture needle of the puncture needle, so that the inner end of the puncture needle passes through the tube plug and enters the liquid sampling tube;

Make the aqueous humor in the anterior chamber pass through the puncture needle and flow into the liquid collection tube under the pressure difference between the intraocular pressure and the negative pressure;

Pull out the aqueous humor collection device from the anterior chamber; and

Take out the liquid sampling tube assembly from the outer cylinder.

Optionally, the rear end of the sampling tube assembly is pushed 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 tube plug The liquid collection tube includes:

Hold the aqueous humor collection device with one hand, and use the index finger to push the rear end of the liquid collection tube assembly.

The third aspect of the present invention provides a method for collecting aqueous humor from the eyes of a subject, including:

Pierce the outer end of the puncture needle of the puncture needle of the aforementioned aqueous humor collection device into the anterior chamber of the eye, wherein the pressure in the fluid collection tube is lower than the intraocular pressure of the subject;

Push 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 of the puncture needle, so that the inner end of the puncture needle passes through the tube plug and enters the Collection tube

Make the aqueous humor in the anterior chamber of the eye pass through the puncture needle and flow into the liquid collection tube under the pressure difference between the intraocular pressure and the negative pressure;

Pull out the aqueous humor collection device from the anterior chamber; and

Take out the liquid sampling tube assembly from the outer cylinder.

Optionally, the rear end of the liquid sampling tube assembly is pushed 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 passes through the tube Plugging into the collection tube includes:

Optionally, it 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.

In the present invention, the liquid sampling tube assembly is provided with a tube plug so that the liquid sampling tube lumen is in a negative pressure state. When the inner end of the puncture needle pierces the tube plug to drain aqueous humor to the liquid sampling tube lumen, The amount of fluid in the lumen 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 the aqueous humor is gradually reduced, thereby avoiding the dangerous situation of sudden drop in intraocular pressure and greatly improving safety. In addition, since it is defined that the static friction coefficient μ1 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 μ2, 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.

Other features and advantages of the present invention will be described in detail in the following specific embodiments.

Description of the drawings

The accompanying drawings are used to provide a further understanding of the present invention and constitute a part of the specification. Together with the following specific embodiments, they are used to explain the present invention, but do not constitute a limitation to the present invention. In the attached picture:

Figure 1 is a perspective view of an aqueous humor collection device in an embodiment of the present invention;

Figure 2 is a front view of the aqueous humor collection device in an embodiment of the present invention;

3 is a main cross-sectional view of the aqueous humor collection device in an embodiment of the present invention when the puncture needle does not pierce the tube plug;

4 is a main cross-sectional view of the aqueous humor collection device in an embodiment of the present invention when a puncture-proof partition is provided;

Figure 5 is a cross-sectional view of the aqueous humor collection device in an embodiment of the present invention;

6 is a schematic structural diagram of the puncture needle of the aqueous humor collection device according to an embodiment of the present invention when a peripheral wall water outlet hole is provided;

FIG. 7 is a schematic structural view of the pipe plug of the aqueous humor collection device in an embodiment of the present invention when the pipe plug has an open peripheral wall and a semicircular pipe plug exhaust channel;

8 is a schematic structural view of the pipe plug of the aqueous humor collection device according to an embodiment of the present invention when the pipe plug has an open peripheral wall and a semi-rectangular pipe plug exhaust channel;

9 is a schematic structural diagram of the pipe plug of the aqueous humor collection device according to an embodiment of the present invention when a peripheral wall closed and circular pipe plug exhaust channel is provided;

10 is a schematic structural view of the pipe plug of the aqueous humor collection device according to an embodiment of the present invention when a peripheral wall closed and arc-shaped pipe plug exhaust channel is provided;

11 is a schematic structural diagram of the liquid collection tube and the support tube frame of the aqueous humor collection device in an embodiment of the present invention when connected by a buckle;

12 is a schematic structural view of the liquid collection tube of the aqueous humor collection device in an embodiment of the present invention when a convex point-like limit protrusion is integrally formed;

Fig. 13 is a schematic structural diagram of the liquid collection tube of the aqueous humor collection device in an embodiment of the present invention when a corrugated stop protrusion is integrally formed;

14 is a schematic structural diagram of the liquid collection tube of the aqueous humor collection device according to an embodiment of the present invention when the tube kit is sheathed and the limiting protrusion is in the shape of a convex point;

15 is a schematic structural diagram of the liquid collection tube of the aqueous humor collection device in an embodiment of the present invention when the tube kit is sheathed and the limiting protrusion is corrugated;

16 is a schematic structural diagram of the liquid collection tube of the aqueous humor collection device according to an embodiment of the present invention when the tube kit is sheathed and the limiting protrusion is in the shape of an oblique tooth;

FIG. 17 is a schematic structural diagram of the supporting tube frame of the aqueous humor collection device in an embodiment of the present invention when a convex point-like limiting protrusion is integrally formed;

18 is a schematic structural view of the supporting tube frame of the aqueous humor collection device in an embodiment of the present invention when a corrugated limiting protrusion is integrally formed;

19 is a schematic structural view of the supporting tube frame of the aqueous humor collection device in an embodiment of the present invention when the oblique tooth-shaped limiting protrusion is integrally formed;

20 is a schematic structural view of the supporting tube frame of the aqueous humor collection device in an embodiment of the present invention when the tube kit is sheathed and the limiting protrusion is in the shape of a convex point;

21 is a schematic structural view of the supporting tube frame of the aqueous humor collection device in an embodiment of the present invention when the tube kit is sheathed and the limiting protrusion is corrugated;

FIG. 22 is a schematic structural diagram of the supporting tube frame of the aqueous humor collection device in an embodiment of the present invention when the tube kit is sheathed and the limiting protrusion is in the shape of a helical tooth.

Description of reference signs:

100 Aqueous Water Collection Device

1 External cylinder 2 puncture needles

3 Liquid collection tube assembly 4 Needle holder

5 Anti-puncture spacers 6 6 Limiting protrusions

7 Needle caps 8 soft sleeves

11 Separator insertion slot 21 21 Water outlet hole on the wall

22 Axial water outlet hole 31 Liquid sampling pipe

32 Supporting the pipe frame 33 Pipe plugging

34 Tube kit 35 Annular groove

36 Groove vent holes 37 Ring limiters

311 Liquid collection pipe card slot 321 Pipe rack buckle

322 Pipe rack snap button 331 Pipe plug exhaust channel

332 Piercing blind guide holes

Detailed ways

The specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. It should be understood that the specific embodiments described here are only used to illustrate and explain the present invention, but not to limit the present invention.

The aqueous humor collection device according to the present invention will be described below with reference to the drawings.

In some embodiments, as shown in FIGS. 1 to 16, the present invention provides an aqueous humor collection device 100, 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. When the puncture needle 2 is fixedly installed at the installation end of the puncture needle, 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.口的管塞33。 Port of the pipe plug 33. Optionally, 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. Optionally, 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. Preferably, the static friction coefficient between the tube plug 33 and the inner peripheral wall of the outer cylinder is μ1, and the static friction coefficient between the tube plug 33 and the nozzle of the liquid sampling tube is μ2, and satisfies: μ1<μ2. Alternatively, 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. For example, 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. Optionally, 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. Optionally, 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. For example, 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. , In order to drive and control the liquid sampling tube and the tube plug to move along the axial direction of the outer cylinder cavity and maintain its stability.

In some embodiments, when the aqueous humor collection device 100 in the exemplary embodiment of the present invention is used for anterior chamber puncture, 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 is soft The 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. During this collection process, because the nozzle of the liquid sampling tube is sealed by the tube plug 33, the lumen of the liquid sampling tube is always in a negative pressure state, but as the amount of liquid in the lumen gradually increases, the pressure in the lumen and the pressure in the anterior chamber The difference is gradually reduced, so the drainage speed of aqueous humor will gradually decrease, so as to avoid the dangerous situation of sudden drop in intraocular pressure, and greatly improve the safety of puncture drainage. In addition, optionally, 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 stability of the plug moving along the axial direction of the outer cylinder cavity. Optionally, 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.

In some embodiments, after the aqueous humor is collected, 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.

In some embodiments, because it is defined that the static friction coefficient μ1 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 μ2, 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.

In some embodiments, when the pipe plug 33 and the inner peripheral wall of the outer cylinder are in contact with each other, in order to better prevent the pipe plug 33 from falling off, 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. For example, 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.

In some embodiments, the aqueous humor collection device 100 includes an anti-sloshing structure for limiting the displacement of the sampling tube assembly 3 along the radial direction of the outer cylinder cavity. In some embodiments, 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. For example, under this structure, it can be ensured that 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.

In some embodiments, as shown in FIGS. 3 and 4, 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. Increase the plugging resistance of the sampling tube assembly 3, so that the operator can feel a certain pushing feel, so as to avoid the inaccurate puncture caused by the too fast moving speed when the sampling tube assembly 3 is pushed toward the inner end of the puncture needle In order to prevent the inner end of the puncture needle from being inserted into the lumen of the liquid collection tube, the stability and reliability of the puncture drainage process are effectively improved. In addition, the liquid sampling tube assembly 3 can be prevented from being separated from the outer cylinder when the aqueous humor collection device 100 is taken, thereby improving the reliability of the product. Preferably, multiple sets of annular grooves 35 and corresponding annular stoppers 37 can be provided to obtain better effects.

In some embodiments, 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. Optionally, 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. Optionally, there is a certain friction between the compressed soft sleeve that still covers the inner end of the puncture needle that is not inserted into the tube plug and the part in the lumen of the liquid collection tube and the inner end of the puncture needle. Optionally, there may be a certain frictional force between the inner end of the puncture needle and the pipe plug to be penetrated, and/or between the annular stopper and the inner peripheral wall of the outer cylinder.

In some embodiments, after the outer end of the puncture needle is inserted into the anterior chamber of the eye and the inner end of the puncture needle is inserted into the lumen of the liquid collection tube, 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. In the process of aqueous humor collection, as the amount of fluid in the lumen gradually increases, 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. Optionally, 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.

In some embodiments, 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. Optionally, keep the inner end of the puncture needle inserted into the lumen of the fluid collection tube until the pressure in the lumen and the pressure in the anterior chamber reach equilibrium. Optionally, keep the inner end of the puncture needle inserted into the lumen of the liquid collection tube until the drainage of aqueous humor stops. Optionally, 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. Optionally, starting from the insertion of the inner end of the puncture needle into the lumen of the fluid collection tube, 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. Optionally, starting from the time when the inner end of the puncture needle is inserted into the lumen of the liquid collection tube, maintaining or applying an external force to the liquid collection tube assembly 3 can continue until the drainage of aqueous humor stops. Optionally, 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. Optionally, from the time when the inner end of the puncture needle is inserted into the lumen of the liquid collection tube, 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.

In some embodiments, after the outer end of the puncture needle exits the anterior chamber and the application of external force to the collection tube assembly is stopped (for example, after the index finger is loosened), 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. For example, during the whole process of pulling out the liquid sampling tube assembly 3 from the outer cylinder cavity, 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. In addition, 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.

In some embodiments, in order to reduce production difficulty and production cost, the annular limiter 37 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.

In some embodiments, 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, so as to avoid the formation of a gas plug in the outer barrel cavity and affect the smooth plugging and unplugging of the liquid sampling tube assembly 3, thereby improving the aqueous humor collection device 100 The reliability of use.

In some embodiments, as shown in FIGS. 12 to 16, 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.

In some embodiments, 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. Alternatively, 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.

In some embodiments, 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.

In some embodiments, 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. In addition, since 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. For example, referring to FIGS. 12 and 14, a plurality of limiting protrusions 6 arranged at intervals along the circumferential direction may be arranged in a convex point shape.

In some embodiments, the limiting protrusion 6 can also be continuously extended in the circumferential direction. When the limiting protrusion 6 is formed on the inner peripheral wall of the outer cylinder, 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. When the limiting protrusion 6 is formed on the outer peripheral wall of the liquid sampling tube assembly 3, an exhaust gap is also preferably formed between the limiting protrusion 6 and the inner peripheral wall of the outer cylinder. For example, referring to FIGS. 13, 15 and 16, the limiting protrusions 6 continuously extending in the circumferential direction may be arranged in a corrugated shape or a helical tooth shape.

In some embodiments, in order to further improve the plugging and unplugging stability of the liquid sampling tube assembly 3, no matter whether 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. , It is preferable to set the total span of the limiting protrusion 6 along the tube length to not less than half the length of the liquid sampling tube. In other words, when the number of limiting protrusions 6 arranged along the length of the tube is large enough, the formation of a lever fulcrum on the outer peripheral wall of the sampling tube assembly 3 can be avoided, thereby more reliably preventing the sampling tube assembly 3 from shaking in the radial direction. .

In some embodiments, the liquid sampling tube assembly 3 further includes a supporting tube frame 32 for fixing the liquid sampling tube 31. Under this structure, 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. 17 to 22. 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.

In some embodiments, after the aqueous humor is collected, 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. Preferably, the liquid sampling tube 31 and the support tube frame 32 can be fixed by screw connection or snap connection.

For example, referring to FIG. 11, the sampling tube 31 and the supporting tube frame 32 are connected by a snap. When 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. When the liquid sampling tube 31 needs to be taken out, 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.

In some embodiments, the aqueous humor collection device 100 further includes a needle holder 4 for fixing the puncture needle 2. Among them, 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. For example, a threaded connection or a snap connection can be formed between the inner end of the needle holder and the mounting end of the puncture needle.

In some embodiments, the aqueous humor collection device 100 further includes an anti-puncture spacer 5, which is used to isolate the inner end of the puncture needle and the tube plug 33 from each other along the axial direction of the outer cylinder cavity. This prevents the inner end of the puncture needle from piercing the tube plug 33 when the aqueous humor collection device 100 is not used for anterior chamber puncture, which effectively prevents the device from failing before being used. For example, in the case of transportation or misoperation by medical personnel, the puncture-proof partition 5 can prevent the aqueous humor collection device 100 from failing. Of course, in order not to affect the normal puncture and drainage of the aqueous humor collection device 100, the anti-puncture spacer 5 is set as a detachable piece, and the anti-puncture spacer 5 can be removed before the puncture.

For example, referring to FIG. 4, 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 in the cylindrical cavity 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. When 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.

In some embodiments, the aqueous humor collection device 100 further includes a detachable limit structure to prevent the inner end of the puncture needle from piercing the pipe plug due to vibration or misoperation by medical personnel during transportation, causing the aqueous humor collection device 100 fails and/or the liquid sampling tube assembly 3 falls off from the outer cylinder. Optionally, in a packaged or unused aqueous humor collection device, the limiting structure is located at the rear end of the supporting pipe rack. Optionally, in a packaged or unused aqueous humor collection device, the limit structure is located at the installation end of the liquid collection tube of the outer cylinder. Optionally, 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. For example, 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. Optionally, the limiting structure can prevent the relative displacement of the supporting tube frame and the outer cylinder in the axial direction, so as to prevent the inner end of the puncture needle from piercing the tube plug 33 when the aqueous humor collection device 100 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.

In some embodiments, as shown in Figures 7 to 10, 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 sampling 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 And 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. In other words, 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.

In some embodiments, in order to improve the ventilation effect and make the structure of the pipe plug 33 more uniform and reasonable, 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.

The specific shape of the pipe plug exhaust passage 331 may be determined according to actual needs. In some embodiments, referring to FIGS. 7 and 8, 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. In other words, the plug exhaust passage 331 may be set as an exhaust passage with an open peripheral wall. Alternatively, referring to Figures 9 and 10, 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. In addition, 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.

In some embodiments, 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.

In some embodiments, in order to ensure that the inner end of the puncture needle does not shake when piercing the tube plug 33 and affect the accuracy of puncture, 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. For example, referring to FIG. 3, 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.

It should be noted that in the process of piercing the tube plug 33 at the inner end of the puncture needle, it may happen that the axial water outlet 22 at the inner end of the puncture needle is blocked by the material of the tube plug, causing the drainage to be blocked and the device not working properly. jobs. Therefore, in some embodiments, in order to avoid the occurrence of interruption, 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. In this structure, even the axial water outlet hole 22 Blocked by the pipe plug material, 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.

In addition, 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. For this reason, in some embodiments, 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 can 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 optional parameter settings of some components and the like in the aqueous humor collection device 100 of this exemplary embodiment will be described below.

In some embodiments, 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. Optionally, 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. Optionally, 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. Optionally, 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.

In some embodiments, 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. Optionally, 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. Optionally, 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. Considering the stability of the mold, optionally, 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. Optionally, for example, the total length of the puncture needle 2 is or about 35mm, the extension length from the needle hub 4 is or about 6mm, and the extension length from the needle hub 4 inward is or about It is 15 mm, and 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.

In some embodiments, the volume of the aqueous humor collected by the puncture needle 2 can be 10 μL to 100 μL, for example, can be set to 32 μL, 37.5 μL, 40 μL, 45 μL, 48 μL, 50 μL, 51 μL, 55 μL, 60 μL, 62.5 μL, 69 μL, etc. .

In some embodiments, the target volume of the aqueous humor collected by the puncture needle 2 may be 10 μL to 100 μL, for example, it may be set to 32 μL, 37.5 μL, 40 μL, 45 μL, 48 μL, 50 μL, 51 μL, 55 μL, 60 μL, 62.5 μL, 69 μL. Wait. In some embodiments, the use of the aqueous humor collection device and method of the present invention contributes to the accuracy of aqueous humor collection. For example, 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%.

In some embodiments, 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 .

In some embodiments, 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 μL to 310 μL (for example, it can be set to 10 μL, 50 μL, 100 μL, 150 μL, 200 μL, 250 μL , 300μL, etc.), the air pressure range can be set from 1*10 ³ Pa to 1*10 ⁴ Pa. Optionally, the air pressure range in the liquid collection tube 31 provided with the tube plug 33 (that is, the negative pressure liquid collection tube 31) is set to be between 8mmHg and 40mmHg, such as 8mmHg to 10mmHg, 10mmHg to 15mmHg, 15mmHg to 20mmHg, 20mmHg 25mmHg, 25mmHg to 30mmHg, 30mmHg to 35mmHg, or 35mmHg to 40mmHg.

In some embodiments, 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, and the diameter of the support tube frame 32 can be set to 5 mm to 20 mm when it is a circular tube frame.

In addition, 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 tube plug 33 and the ring limiter The position member 37 can be made of rubber.

In some embodiments, 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 μL to 310 μL, and the air pressure range in the liquid sampling tube is set to be between 8 mmHg and 40 mmHg.

In some embodiments, the present invention provides a method of collecting aqueous humor from the cornea, including:

Pierce the outer end of the puncture needle 2 of the aforementioned aqueous humor collection device 100 into the anterior chamber of the eye;

Push the back end of the liquid sampling tube assembly 3 to move the liquid sampling tube 31 in the liquid sampling tube assembly 3 toward the inner end of the puncture needle 2 so that the inner end of the puncture needle passes through the tube plug 33 and enters the liquid sampling tube 31;

Make the aqueous humor in the anterior chamber pass through the puncture needle 2 under the pressure difference between the intraocular pressure and the negative pressure and flow into the liquid collection tube 31;

Pull out the aqueous humor collection device 100 from the anterior chamber; and

Take out the liquid sampling tube assembly 3 from the outer cylinder 1.

In some embodiments, the step of pushing the rear end of the liquid collection tube assembly 3 may include:

Hold the housing water collection device 100 with one hand, and push the rear end of the liquid collection tube assembly 3 with the index finger.

In some embodiments, 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.

In some embodiments, 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. Optionally, the liquid sampling tube assembly 3 can be ejected naturally without applying external force to specifically pull out the liquid sampling tube assembly.

In some embodiments, the present invention provides a method for collecting aqueous humor from the eyes of a subject, including:

Pierce the outer end of the puncture needle 2 of the aforementioned aqueous humor collection device 100 into the anterior chamber of the eye, wherein the pressure in the liquid collection tube 31 is lower than the intraocular pressure of the subject;

Make the aqueous humor in the anterior chamber of the eye pass through the puncture needle 2 under the pressure difference between the intraocular pressure and the negative pressure and flow into the liquid collection tube 31;

Pull out the aqueous humor collection device 100 from the anterior chamber; and

Take out the liquid sampling tube assembly 3 from the outer cylinder 1.

Pierce the outer end of the puncture needle 2 of the aforementioned aqueous humor collection device 100 into the anterior chamber of the eye, wherein the pressure in the liquid collection tube 31 is between 8-40 mmHg and is lower than the intraocular pressure of the subject;

Hold the housing water collection device 100 with one hand, and use your index finger to push the rear end of the liquid collection tube assembly 3 to move the liquid collection tube 31 in the liquid collection tube assembly 3 toward the inner end of the puncture needle 2 to make the puncture needle The inner end passes through the pipe plug 33 and enters the sampling pipe 31;

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;

Pull out the aqueous humor collection device 100 from the anterior chamber;

Stop or reduce the application of external force to the liquid sampling tube assembly to allow the liquid sampling tube assembly to rebound; and

Take out the liquid sampling tube assembly 3 from the outer cylinder 1.

In some embodiments, 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. Optionally, 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. Optionally, the air pressure range in the liquid collection tube 31 provided with the tube plug 33 (that is, the negative pressure liquid collection tube 31) 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. Optionally, the air pressure range in the liquid collection tube 31 provided with the tube plug 33 (ie, the negative pressure liquid collection tube 31) is about 0.5mmHg, 1mmHg, 2mmHg, 3mmHg, 4mmHg, 5mmHg, 6mmHg lower than the intraocular pressure of the subject. , 7mmHg, 8mmHg, 9mmHg or 10mmHg.

In some embodiments, the present invention provides a method of assembling the aforementioned aqueous humor collection device 100. Optionally, 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. Optionally, the negative pressure in the negative pressure box can be adjusted to assemble liquid collection tubes with different negative pressure values. For example, the aforementioned aqueous humor collection device 100 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.

In the description of the present invention, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", " "Back", "Left", "Right", "Vertical", "Horizontal", "Top", "Bottom", "Inner", "Outer", "Clockwise", "Counterclockwise", "Axial", The orientation or positional relationship indicated by "radial", "circumferential", etc. is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying the pointed device or element It must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation to the present invention.

In addition, the terms "first" and "second" are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of indicated technical features. Therefore, the features defined with "first" and "second" may explicitly or implicitly include at least one of the features. In the description of the present invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise specifically defined.

In the present invention, unless otherwise clearly defined and defined, the terms "installed", "connected", "connected", "fixed" and other terms should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection. , Or integrated; it can be mechanically connected, or it can be electrically connected or can communicate with each other; it can be directly connected or indirectly connected through an intermediate medium, it can be the internal communication of two components or the interaction relationship between two components, Unless otherwise clearly defined. For those of ordinary skill in the art, the specific meaning of the above-mentioned terms in the present invention can be understood according to specific circumstances.

In the present invention, unless expressly stipulated and defined otherwise, the first feature “on” or “under” the second feature may be in direct contact with the first and second features, or the first and second features may be indirectly through an intermediary. contact. Moreover, the "above", "above" and "above" of the first feature on the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the level of the first feature is higher than the second feature. The “below”, “below” and “below” of the second feature of the first feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the level of the first feature is smaller than the second feature.

In the description of this specification, descriptions with reference to the terms "one embodiment", "some embodiments", "examples", "specific examples", or "some examples" etc. mean specific features described in conjunction with the embodiment or example , Structure, materials or features are included in at least one embodiment or example of the present invention. In this specification, the schematic representations of the above-mentioned terms do not necessarily refer to the same embodiment or example. Moreover, the described specific features, structures, materials or characteristics can be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art can combine and combine the different embodiments or examples and the characteristics of the different embodiments or examples described in this specification without contradicting each other.

Although the embodiments of the present invention have been shown and described above, it can be understood that the above-mentioned embodiments are exemplary and should not be construed as limiting the present invention. Those of ordinary skill in the art can comment on the foregoing within the scope of the present invention. The embodiment undergoes changes, modifications, substitutions and modifications.

Claims

An aqueous humor collection device, characterized in that the aqueous humor collection device (100) comprises:

The outer cylinder (1) is provided with a puncture needle mounting end and a liquid sampling tube mounting end at both ends of the axial direction;

The puncture needle (2) is fixedly installed at the installation end of the puncture needle 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 (3) includes a liquid sampling tube (31) that is inserted into the barrel cavity of the outer cylinder from the installation end of the liquid sampling tube and can be inserted and pulled out in an axial direction, and is arranged on the outer cylinder. A tube plug (33) used to seal the mouth of the liquid collection tube is used in the barrel cavity;

Wherein, the static friction coefficient between the pipe plug (33) and the inner peripheral wall of the outer cylinder is μ1, and the static friction coefficient between the pipe plug (33) and the nozzle of the liquid collection tube is μ2, and satisfies: μ1< μ2;

Alternatively, the pipe plug (33) is arranged at intervals on the inner peripheral wall of the outer cylinder.
The aqueous humor collection device according to claim 1, wherein the pipe plug (33) forms a smooth contact with the inner peripheral wall of the outer cylinder.
The aqueous humor collection device according to claim 1, characterized in that, the aqueous humor collection device (100) further comprises a device for restricting the liquid collection tube assembly (3) along the radial direction of the outer cylinder Displacement anti-shake structure.
The aqueous humor collection device according to claim 3, wherein the anti-sloshing structure comprises an annular groove (35) formed on the outer peripheral wall of the liquid sampling tube assembly (3) and the annular ring An annular stopper (37) is provided in the groove (35), and the radially outer end of the annular stopper (37) abuts against the inner peripheral wall of the outer cylinder.
The aqueous humor collection device according to claim 4, wherein the groove side wall of the annular groove (35) is formed with a groove vent hole (36) penetrating along the axial direction of the outer cylinder cavity. ), the barrel cavity of the outer barrel is connected to the groove vent (36) in the barrel cavity area between the pipe plug (33) and the puncture needle mounting end.
The aqueous humor collection device according to claim 4, wherein the liquid sampling tube assembly (3) comprises a supporting tube frame (32), and the liquid sampling tube (31) is inserted into the supporting tube frame ( In the inner cavity of the pipe frame of 32), the annular groove (35) is arranged on the outer peripheral wall of the supporting pipe frame (32).
The aqueous humor collection device according to claim 3, wherein the liquid sampling tube assembly (3) further comprises a supporting tube frame (32), and the liquid sampling tube (31) is inserted into the supporting tube frame. In the inner cavity of the pipe rack of (32), the anti-sloshing structure includes a limiting protrusion (6) protruding from the outer peripheral wall of the supporting pipe rack (32) or from the inner peripheral wall of the outer cylinder, the limiting protrusion The two radial ends of (6) are respectively connected to the outer peripheral wall of the support pipe frame (32) and the inner peripheral wall of the outer cylinder.
The aqueous humor collection device according to claim 1, characterized in that, the aqueous humor collection device (100) further comprises a needle seat (4) for fixedly installing the puncture needle (2), and the needle seat ( 4) A quick plug connection is formed between the inner end of the needle seat and the puncture needle installation end.
The aqueous humor collection device according to any one of claims 1 to 8, characterized in that the aqueous humor collection device (100) further comprises a device for isolating the puncture along the axial direction of the outer cylinder cavity An anti-puncture spacer (5) between the inner end of the needle and the pipe plug (33), the anti-puncture spacer (5) is a detachable piece.
The aqueous humor collection device according to claim 9, characterized in that the peripheral wall of the outer cylinder (1) is provided with a spacer insertion groove (11), and the outer cylinder cavity is in the puncture needle The barrel cavity area between the end and the pipe plug (33) communicates with the spacer insertion groove (11), and the anti-puncture spacer (5) is inserted into the spacer insertion slot (11) In the cavity area.
A method of collecting aqueous humor from the cornea includes:

Pierce the outer end of the puncture needle (2) of the aqueous humor collection device (100) according to any one of claims 1 to 10 into the anterior chamber of the eye;

Push the rear end of the liquid sampling tube assembly (3) so that the liquid sampling tube (31) in the liquid sampling tube assembly (3) moves toward the inner end of the puncture needle (2) to make the puncture The inner end of the needle passes through the tube plug (33) and enters the liquid collection tube (31);

Making the aqueous humor of the anterior chamber pass through the puncture needle (2) under the pressure difference between the intraocular pressure and the fluid collection tube and flow into the fluid collection tube (31);

Pull out the aqueous humor collection device (100) from the anterior chamber; and

Take out the liquid sampling tube assembly (3) from the outer cylinder (1).
The method according to claim 11, wherein the rear end of the sampling tube assembly (3) is pushed so that the sampling tube (31) in the sampling tube assembly (3) faces the puncture needle (2) Moving the inner end of the puncture needle so that the inner end of the puncture needle passes through the tube plug (33) into the liquid collection tube (31) includes:

Hold the aqueous humor collection device (100) with one hand, and gently push the rear end of the liquid collection tube assembly (3) with an index finger.
A method for collecting aqueous humor from the eyes of a subject, including:

The outer end of the puncture needle (2) of the aqueous humor collection device (100) according to any one of claims 1 to 10 is pierced into the anterior chamber of the eye, wherein the pressure in the liquid collection tube (31) Lower than the intraocular pressure of the subject;

Push the rear end of the sampling tube assembly (3) to move the sampling tube (31) in the sampling tube assembly (3) toward the inner end of the puncture needle (2), so that the The inner end of the puncture needle passes through the tube plug (33) and enters the liquid collection tube (31);

Make the aqueous humor in the anterior chamber of the eye pass through the puncture needle (2) and flow into the liquid collection tube (31) under the pressure difference between the intraocular pressure and the negative pressure;

Pull out the aqueous humor collection device (100) from the anterior chamber; and

Take out the liquid sampling tube assembly (3) from the outer cylinder (1).
The method according to claim 13, wherein the rear end of the sampling tube assembly (3) is pushed so that the sampling tube (31) in the sampling tube assembly (3) faces the puncture needle (2) The inner end of the puncture needle of) moves so that the inner end of the puncture needle passes through the tube plug (33) and enters the liquid collection tube (31) including:

Hold the aqueous humor collection device (100) with one hand, and gently push the rear end of the liquid collection tube assembly (3) with an index finger.
The method according to claim 13 or 14, further comprising selecting the negative pressure inside the liquid collection tube (31), the negative pressure being lower than the intraocular pressure of the subject's eye.