CN113288580A

CN113288580A - A aqueous humor drainage ware for implanting glaucoma patient is intraocular

Info

Publication number: CN113288580A
Application number: CN202110702478.9A
Authority: CN
Inventors: 任冬妮; 王福乐; 殷瑞雪; 张洪波
Original assignee: Mingche Biotechnology Guangzhou Co ltd
Current assignee: Mingche Biotechnology (Suzhou) Co.,Ltd.
Priority date: 2021-06-24
Filing date: 2021-06-24
Publication date: 2021-08-24
Also published as: WO2022268143A1; CN221814414U

Abstract

The invention relates to the field of medical instruments, in particular to an aqueous humor drainage device implanted into eyes of a glaucoma patient. The invention provides an aqueous humor drainage device for implanting into eyes of glaucoma patients, which is made of a material with good biocompatibility, has high drainage efficiency and obvious intraocular pressure reduction in clinic, optimizes the processing technology by adopting a microfluidic and mold-turning technology, improves the production efficiency and is convenient for batch production.

Description

A aqueous humor drainage ware for implanting glaucoma patient is intraocular

Technical Field

The invention relates to the field of medical instruments, in particular to a drainage instrument for reducing intraocular pressure of a glaucoma patient.

Background

Glaucoma, a slowly progressing optic neuropathy, ranks as the second leading cause of blinding eye disease worldwide, and is the leading cause of irreversible blindness. Chinese glaucoma manual (2020) indicates that in 2020 in China, patients with glaucoma will reach 2100 ten thousand and the number of blinding people reaches 567 ten thousand. The pathogenesis of the eye damage is that aqueous humor accumulates in the anterior chamber of the eyeball, so that the intraocular pressure is excessively increased, and then the optic nerve cells are permanently damaged, and the eye damage and the corresponding visual field defect are typically characterized. The treatment of glaucoma has been based on the principle of lowering intraocular pressure, preventing or slowing down damage to the optic nerve of the patient as much as possible, and preserving existing vision. When the traditional medicine has poor treatment effect or patients cannot tolerate long-term administration, the laser trabeculoplasty can be used for treatment; minimally Invasive Glaucoma Surgery (MIGS) is considered when laser therapy also fails to bring intraocular pressure down to a safe range or maximum resistance to drug therapy fails; when none of the above treatments have achieved the desired result, a more invasive trabeculectomy is the last consideration. In short, glaucoma surgery is a choice made to maximize patient safety while controlling the disease condition to not progress or improve. Comparative analysis is now made of current treatment modalities.

1) Eye drop liquid: in the treatment of glaucoma, commonly used drugs are β adrenergic blockers, prostaglandin derivatives, adrenergic receptor agonists, carbonic anhydrase inhibitors, and the like. These drugs control intraocular pressure mainly by inhibiting the production of aqueous humor and promoting the drainage of aqueous humor. The drug treatment plays a great role in disease control, but the drug treatment also brings many side effects, for example, the beta adrenergic blocker can cause the bradycardia, the blood pressure drop and even the syncope; the side effects of prostaglandin derivatives are mainly manifested by temporary local burning, stabbing pain and conjunctival congestion after dripping, iris pigment increase after long-term administration, eyelash thickening, etc.; alpha adrenoceptor agonists have a high allergic response, and their long-term use is limited by their impact on the central nervous system and the resulting significant systemic arterial pressure drop. In addition, in the long term, drug therapy can only delay the development of the disease and cannot fundamentally treat glaucoma.

2) Laser Trabeculoplasty (SLT): the selective photothermolysis is used for generating biological effect, so that endothelial cells in the trabecular meshwork tissue are activated, certain cell active factors such as IL-1 and TNF are secreted, the redifferentiation of the trabecular meshwork cells is activated, and macrophages in the trabecular meshwork are induced to play a role in digesting, transporting or phagocytosing extracellular substances deposited in the gap of the trabecular meshwork, so that the extracellular matrix of the trabecular meshwork is remodeled, and the outflow resistance of aqueous humor is reduced. Although SLT is noninvasive and simple to operate, the intraocular pressure reduction amplitude is low, the action time is short, a patient needs to visit a doctor repeatedly, and the SLT is only suitable for early glaucoma.

3) Drainage tube + drainage plate: conventional flow diverters are typically relatively bulky, such as the MIDI-Ray tube manufactured by Santen Pharmaceutical Co., Ltd, Japan, with an inner diameter of 0.1mm, an outer diameter of 0.35mm, and a length of 12mm, with the addition of a disk structure up to 7mm in diameter. Such surgical instruments are large in wound area, product exposure and postoperative fluctuations in intraocular pressure that can last for months. Postoperative complications are more frequent, including excessive drainage causing intraocular pressure to be too low, insufficient drainage causing high ocular pressure, conjunctival fibrosis hyperplasia blockage attached to the drainage plate, catheter displacement or exposure, catheter internal orifice blockage and the like.

4) Trabeculectomy: trabeculectomy (TE) is considered the gold standard for surgical treatment of glaucoma, the principle of which is to bypass the physiological aqueous outflow tract, creating a pathway for aqueous drainage from the anterior chamber to the subconjunctival space, which has proven to be effective, safe and repeatable. There are some long-term or short-term complications, such as postoperative hypotony, superficial anterior chamber, choroidal hemorrhage, hyphema, etc., and long-term stages such as increased cataract, bleb inflammation, bleb scarring leading to transient or progressive increase in intraocular pressure, and some patients have frequent postoperative injections of bleb anti-fibrotic drugs to ensure success of the surgery.

5) MIGS minimally invasive surgery: the term Minimally Invasive Glaucoma Surgery (MIGS), started around 2008, the first MIGS instrument, ident, was registered with the FDA in 2012. MIGS has now become a common term for ophthalmology and plays an increasingly important role in the treatment of glaucoma patients. MIGS is intended to reduce ocular pressure by improving aqueous outflow through various methods without damaging the conjunctiva and sclera as much as possible. The advantages of the MIGS instrument are remarkable, firstly, little damage to tissues and little adverse reaction after operation, and can be used for treating intractable glaucoma or more complicated glaucoma by being used for open-angle glaucoma patients or being used together with other operation modes (cataract ultrasonic emulsification operation). MIGS is particularly suitable for mild and moderate glaucoma patients, and the operation mode is mainly characterized by good safety. At present, MIGS alone does not have a good effect on patients with advanced glaucoma, and other filtering operations such as trabeculectomy are required to be combined for treatment. Common complications of MIGS include ocular hypotension, filtration bleb prick, and anterior chamber bleeding.

MIGS achieves control of intraocular pressure in different ways. The first method is to increase the outflow of trabecular meshwork and schlemm's tubes. Trabecular meshwork has traditionally been considered the site of greatest resistance to aqueous humor outflow. This resistance can be overcome by bypassing or removing such tissue. Such as placing a trabecular meshwork bypass stent to achieve avoidance of drag effects. Another method of bypassing trabecular meshwork resistance is to perform a direct atriotomy or trabeculotomy. The schlemm tube can be expanded by a stent and expanded with viscoelastic. The second approach seeks to increase outflow by alternative routes, such as by placing a stent into the suprachoroidal space, or shunting to the subconjunctival space. The third method is to destroy the tissue of aqueous humor production to reduce the production of aqueous humor. Such as ciliary photocoagulation, a laser probe is inserted through a transparent corneal incision for ablating the ciliary body.

MIGS has been widely implemented, mainly for several reasons: 1. compared with the traditional glaucoma operation, the intraocular pressure can be reduced lower, and the complication is less; 2. the treatment effect of the patient is better, and the pain and discomfort of the patient after the operation are greatly relieved; 3. compared with the traditional operation type, the doctor has a shorter learning curve; 4. the application is wider, can perform glaucoma and cataract combined operation, and has good effect on partial intractable and complicated glaucoma; 5. other conventional glaucoma surgery (e.g., trabeculectomy or glaucoma drainage implant) may still be performed after the surgery. The development of MIGS is based primarily on the following:

XeN implants treat glaucoma, the approach and drainage path of which are: implanting the inner path and forming a subconjunctival space; the action principle is as follows: the micro fistula is directly communicated with the anterior chamber and the subconjunctival cavity to increase the drainage of aqueous humor; the structural design characteristics: is made of glutaraldehyde crosslinked gelatin, is soft when meeting water, and has the length of 6mm, the inner diameter of 45mm and the outer diameter of 125 mm. The operation is simple, the cornea is inserted from the inside of the cornea, namely the anterior chamber, the wound is small, the invasiveness is small, the subconjunctival incision is not exposed, and the drainage tube is highly required to be positioned; indications are as follows: can be used for treating mild-moderate open-angle glaucoma, including patients who have failed the operation and have no effect on the treatment of a large amount of medicaments, can be used alone, and can also be used for patients with refractory glaucoma and partial closed-angle glaucoma by combining with the cataract ultrasonic emulsification operation; contraindications: neovascular glaucoma, patients with ocular or ocular surface inflammation, limbal stem cell failure and pregnancy; complications are as follows: ocular hypotension; filtering, soaking and needling.

The PRESERFLO Microshunt glaucoma drainage device has the following approach mode and drainage path: implanting in an external way to form a subconjunctival space; the action principle is as follows: directly communicating the anterior chamber with the subconjunctival cavity to increase aqueous humor drainage; the structural design characteristics: made of ultrapure medical grade poly (styrene-block isobutylene-block styrene) with a flanking structure. Microspin has a total length of 8.5mm, an inner diameter of the tube of 70um, an outer diameter of 350um, a distance between a lateral wing and a proximal end face of the tube of 3.1mm, a distance between a distal end face of the tube of 4.4mm and a wingspan of 1.1 mm. When the artificial limb is implanted, an incision is made from the outside and the artificial limb is inserted into the anterior chamber, the conjunctiva needs to be peeled off, certain invasive injury is caused, but the operation is simpler due to external operation; indications are as follows: primary open angle glaucoma, patients with uncontrolled intraocular pressure after maximum drug resistance and/or who must undergo surgery for glaucoma progression, patients with partially refractory glaucoma, or may play a role in diseases such as iridocorneal endothelial syndrome, uveitis glaucoma, and neovascular glaucoma; contraindications: is not suitable for closed angle glaucoma, and patients who have failed the previous filtration surgery; complications are as follows: ocular hypotension; filtering, soaking and needling.

The approach and drainage path of the iStent implant are: implantation in the internal passage, Schlemm's canal; the action principle is as follows: the artificial cornea is placed in trabecular tissue between the iris and the cornea and can be connected with the anterior chamber and the schlemm's canal, so that the drainage resistance of aqueous humor is reduced, and the aqueous humor can smoothly flow into the schlemm's canal; the structural design characteristics: a surface heparin coated titanium stent, weighing about 60 micrograms, 120 micron inner diameter, 0.5mm by 0.25mm by 1.0 mm. Precision machining is carried out, the outlet of the flow channel is not a single outlet, four auxiliary outlets are additionally arranged, and the middle part of the concave waist is designed to facilitate the fitting and fixing of an instrument and tissues; indications are as follows: for treating adult mild-moderate primary open angle glaucoma; contraindications: angle-closure glaucoma, neovascular glaucoma, rapid increase in ocular pressure, ocular inflammation, and diseases that cause superior scleral venous hypertension, such as goiter, ocular tumors, s-w syndrome; the anterior chamber angle is irregular in shape; complications are as follows: stent malposition, occlusion, hyphema.

The Hydrus implantation has the following approach mode and drainage path: implantation in the internal passage, Schlemm's canal; the action principle is as follows: the scleral venous sinus is expanded, and the aqueous humor drainage resistance is reduced; the structural design characteristics: nitinol, about 8mm long, with a radial dimension of about 240 um. The structure is not easy to deform, and the bracket is directly arranged in a Schlemm's tube; indications are as follows: is used for treating patients with mild-moderate primary open-angle glaucoma combined with cataract surgery, and pseudoexfoliation glaucoma patients; contraindications: closed angle glaucoma, secondary glaucoma such as neovascular, uveitis, traumatic, steroid-induced and lens-induced glaucoma, glaucoma patients previously treated with ciliary body or schlemm's canal trauma such as ciliary body ablation, trabeculectomy, etc.; complications are as follows: hyphema, nickel ion vessel wall toxicity, corneal punctate staining, corneal epithelial erosion, stromal edema, and tissue adhesion.

The treatment of the CyPass miniature stent has the following access modes and drainage paths: the suprachoroidal space; the structural design characteristics: a polyamide; indications are as follows: adult, mild to moderate primary open angle glaucoma, POAG, with combined cataracts; contraindications: glaucoma other than primary open angle glaucoma, irregular shape of the angle of the atrium; complications are as follows: FDA Class I top grade recall, possibly to disability or death.

In general, different products have their own characteristics and different ranges of indications. From an access point of view, implantation by the internal route is less destructive to tissue than implantation by the external route. XEN adopts the gelatin of glutaraldehyde cross-linking to make, and it has good pliability and biocompatibility, and the operation mode adopts the implantation of cornea inner route, has greatly reduced the risk of cornea external infection, and its simple and easy operation mode, fluent structure appearance, reasonable internal diameter size can play good intraocular pressure control effect when alleviating patient's misery. Furthermore, XEN can be used for refractory glaucoma, drug intolerant glaucoma patients, and for partially closed angle glaucoma patients in combination with phacoemulsification surgery. From the perspective of the drainage pathway, Cypass drainage to the suprachoroidal space can avoid management of post-operative filtering bleb, but at present, the product has been recalled globally, and the drainage risk remains to be demonstrated. Seen as a whole, XeN is the MIGS product with the most obvious comprehensive advantages at present.

Disclosure of Invention

The invention aims to provide an aqueous humor drainage device implanted into eyes of a glaucoma patient, which has high drainage efficiency clinically and obvious intraocular pressure reduction.

The technical scheme of the invention is as follows: the drainage device is integrally tubular, a drainage channel is formed in the drainage device and used for draining aqueous humor to a filtering tissue, and the drainage channel is an equal-diameter drainage channel or a gradually-enlarged-diameter drainage channel.

Preferably, the drainage channel is an equal-diameter drainage channel, and the diameter of the drainage channel is 0.03-0.3 mm.

Preferably, the drainage channel is a gradually-enlarged diameter drainage channel, the diameter of the large-diameter end of the drainage channel is 0.05mm-0.3mm, and the diameter of the small-diameter end of the drainage channel is 0.03mm-0.15 mm.

Preferably, the axial length of the flow diverter is 3-15 mm.

Preferably, the outer diameter of the flow diverter is 0.1mm-0.6 mm.

Preferably, the outer side wall of the drainage device is also provided with an auxiliary fixing structure for preventing the drainage device from moving axially.

Preferably, the auxiliary fixing structure is a convex fixing structure or a concave fixing structure.

Preferably, the protrusion fixing structure is a convex ring, a convex point, a convex rib, a convex sheet or a thread protrusion distributed on the outer side wall of the drainage device.

Preferably, the concave fixing structures are concave points, grooves or concave thread structures distributed on the outer side wall of the flow diverter.

Preferably, the flow diverter is made of a biocompatible material.

Preferably, the biocompatible material is a photo-curable biocompatible material.

Preferably, the photo-curable biocompatible material is an epoxy (meth) acrylate material, a polyester (meth) acrylate material, a polyurethane (meth) acrylate material, a (meth) acrylate monomer, a (meth) acrylate modified natural biomaterial, preferably, triethoxy bisphenol a dimethacrylate, bisphenol a epoxy methacrylate, polyethylene glycol di (meth) acrylate, a (meth) acrylate modified gelatin, a (meth) acrylate modified hyaluronic acid.

A method for preparing an aqueous humor drainage device implanted in eyes of a glaucoma patient, which adopts a microfluidic manufacturing method.

The invention has the beneficial effects that:

(1) the invention relates to an aqueous humor drainage device for implanting in eyes of glaucoma patients, which adopts a circular section, the figure coefficient of the circular section is the smallest in all different cross-sectional shapes, the area surrounded by the same perimeter is the largest in the circular shape, the stimulation of the circular outer surface to tissues is small, and the smooth curved surface can obviously reduce the atrial hemorrhage, so the circular section is selected as the final section.

(2) According to the aqueous humor drainage device implanted into eyes of glaucoma patients, the drainage channel adopts the gradually-enlarged diameter, and compared with the equal-diameter pipelines of XEN, PRESERFLO Microscint and other products, the gradually-enlarged diameter drainage channel provides a directional drainage effect, and along with the increase of the diameter of the pipeline, the flow speed is reduced, the pressure is increased, so that aqueous humor is drained to subconjunctival gaps at a faster rate, and therefore the aqueous humor drainage device has higher initial drainage efficiency; conversely, the pressure decreases and the flow rate increases, thus preventing the generation of reflux due to the higher anterior chamber pressure.

(3) According to the aqueous humor drainage device implanted into the eye of a glaucoma patient, the diameter of the large-diameter end of the gradually-enlarged diameter drainage channel is 0.05mm-0.3mm, the diameter of the small-diameter end is 0.03mm-0.15mm, the smaller the diameter of the pipeline is, the lower the probability of low intraocular pressure is, but the smaller the diameter of the pipeline is, on one hand, cell debris and blood clots are easy to block the pipeline, and on the other hand, the treatment effect and the drainage efficiency are reduced; from the viewpoint of design, for the prevention and treatment of low intraocular pressure, on one hand, the inner diameter size is carefully selected, on the other hand, the occurrence of low intraocular pressure is inhibited through reasonably selecting the shape of the tube cavity, when the anterior chamber pressure is too low, the pressure difference between the anterior chamber and the follicular is reduced, which reduces the discharge rate, and in addition, as the diameter of the drainage device of the drainage channel with the gradually expanding diameter is increased, the flow rate is reduced, the pressure tends to be increased (the pressure along the process of the equal-diameter tube is not changed), the trend of pressure increase is inhibited because the anterior chamber pressure is lower, and the inhibition is easier to prevent the occurrence of low intraocular pressure compared with the equal-diameter tube.

(4) The aqueous humor drainage device for implanting into eyes of glaucoma patients has a simple and smooth structure, fewer accessories and smaller invasion influence on tissues; and the micro-fluidic and rollover technology is adopted, the processing technology is optimized, the production efficiency is improved, and the batch production is facilitated.

Drawings

The invention is further illustrated with reference to the following figures and examples.

FIG. 1 is a cross-sectional view of a flow diverter of example 1 of the present invention;

FIG. 2 is a cross-sectional view of a flow diverter of example 2 of the present invention;

FIG. 3 shows the auxiliary fixing structure of the outer side wall of the flow diverter is uniformly distributed convex rings;

FIG. 4 shows the auxiliary fixing structure of the outer side wall of the flow diverter is a convex ring arranged at the end part;

FIG. 5 shows that the auxiliary fixing structure of the outer side wall of the flow diverter is evenly distributed salient points;

FIG. 6 shows the auxiliary fixing structure of the outer side wall of the flow diverter is a convex point arranged at the end part

FIG. 7 shows that the auxiliary fixing structure of the outer side wall of the flow diverter is a uniformly distributed rib;

FIG. 8 shows that the auxiliary fixing structure of the outer side wall of the flow diverter is a lug (two lugs) arranged on two sides of the side wall of the flow diverter;

FIG. 9 shows the auxiliary fixing structure of the outer side wall of the flow diverter is a lug (with multiple lugs) arranged on two sides of the side wall of the flow diverter

FIG. 10 shows the auxiliary fixing structure of the outer side wall of the flow diverter is a uniformly distributed thread bulge (small thread pitch);

FIG. 11 shows that the auxiliary fixing structure of the outer side wall of the flow diverter is a uniformly distributed thread bulge (large pitch);

FIG. 12 shows the auxiliary fixing structure of the outer side wall of the flow diverter is a threaded boss arranged at the end part;

FIG. 13 shows the auxiliary fixing structure of the outer side wall of the flow diverter is uniformly distributed concave points;

FIG. 14 shows the auxiliary fixing structure of the outer side wall of the flow diverter as a groove arranged at the end part;

FIG. 15 shows the auxiliary fixing structure of the outer side wall of the flow diverter is a concave thread arranged at the end part.

In the figure: the drainage device comprises a drainage device body 1, a drainage channel 2 and an auxiliary fixing structure 3.

Detailed Description

The present invention will now be described in further detail with reference to the accompanying drawings. These drawings are simplified schematic views illustrating only the basic structure of the present invention in a schematic manner, and thus show only the constitution related to the present invention.

Example 1

As shown in figure 1, the drainage device 1 of the aqueous humor for implanting in the eyes of glaucoma patients is tubular, a drainage channel 2 is formed in the drainage device 1 and is used for draining the aqueous humor to a filtering tissue, and the drainage channel 2 is an equal-diameter drainage channel.

In one embodiment, the diameter of the drainage channel 1 is 0.03-0.3 mm.

In one embodiment, the axial length of the flow diverter is 3-15 mm. The axial length of the flow diverter can be adjusted according to actual conditions.

Example 2

As shown in figure 2, the drainage device 1 of the aqueous humor for implanting in the eyes of glaucoma patients is tubular, a drainage channel 2 is formed in the drainage device and is used for draining the aqueous humor to a filtering tissue, and the drainage channel 2 is a drainage channel with gradually enlarged diameter.

In one embodiment, the maximum diameter of the drainage channel 2 is not more than 0.3mm and the minimum diameter is not less than 0.03 mm. Wherein, the diameter of the large diameter end of the drainage channel 2 is 0.05mm-0.3mm, and the diameter of the small diameter end is 0.03mm-0.15 mm. Preferably, the diameter of the large-diameter end of the drainage channel 2 is 0.05mm-0.15mm, the diameter of the small-diameter end is 0.04mm-0.06mm, the initial flow rate can be 3.5-15 times of the rate of aqueous humor production, and in the range, the venous pressure and the pipeline resistance of the target tissue are adjusted by drainage in a double mode, so that the intraocular pressure can be effectively inhibited.

In one embodiment, the axial length of the flow diverter is 3-15 mm. The axial length of the drainage device can be adjusted according to actual conditions so as to select a proper drainage rate.

Example 3

The difference between the outer side wall of the drainage device and the outer side wall of the drainage device is that the outer side wall of the drainage device is provided with an auxiliary fixing structure 3 for preventing the drainage device from moving axially, wherein the auxiliary fixing structure 3 is a convex ring, a convex point, a convex rib, a convex piece or a thread bulge distributed on the outer side wall of the drainage device.

As shown in fig. 3 and 4, the auxiliary fixing structures 3 are convex rings distributed on the outer side wall of the flow diverter, wherein the convex rings may be uniformly distributed or non-uniformly distributed.

As shown in fig. 5 and 6, the auxiliary fixing structures 3 are protrusions distributed on the outer side wall of the flow diverter, wherein the protrusions can be uniformly distributed on the axial side wall of the flow diverter, or distributed at one end of the side wall of the flow diverter, or distributed at any position of the side wall of the flow diverter.

As shown in fig. 7, the auxiliary fixing structures 3 are ribs distributed on the outer side wall of the flow diverter, wherein the ribs may be ribs uniformly distributed on the circumference of the flow diverter, or may be a single rib.

As shown in fig. 8 and 9, the auxiliary fixing structures 3 are lugs distributed on the outer side wall of the flow diverter, wherein the lugs can be a single piece or multiple pieces.

As shown in fig. 10, 11 and 12, the auxiliary fixing structures 3 are threaded protrusions distributed on the outer sidewall of the flow diverter, wherein the thread pitch of the threaded protrusions can be selected according to actual conditions, and the threaded protrusion structures can also be arranged at one end or in the middle of the outer sidewall of the flow diverter. Example 4

The difference between the outer side wall of the drainage device and the outer side wall of the drainage device is that the outer side wall of the drainage device further comprises an auxiliary fixing structure 3 for preventing the drainage device from moving axially, wherein the auxiliary fixing structure 3 is a concave point, a groove or a concave thread structure distributed on the outer side wall of the drainage device.

As shown in FIG. 13, the auxiliary fixing structures 3 are pits distributed on the outer side wall of the flow diverter, wherein the pits can be uniformly distributed or non-uniformly distributed.

As shown in fig. 14, the auxiliary fixing structures 3 are grooves distributed on the outer side wall of the flow diverter, wherein one or more grooves can be formed.

As shown in FIG. 15, the auxiliary fixing structures 3 are recessed thread structures distributed on the outer side wall of the flow diverter, wherein the thread pitch of the recessed thread structures can be selected according to actual conditions, and the recessed thread structures can also be arranged at one end or the middle part of the outer side wall of the flow diverter.

In one embodiment, the flow director is made of a biocompatible material, specifically an epoxy acrylate, a polyester acrylate, Bis-GMA, SR348, PEGDA, PEGDMA, GelMA, or HAMA.

In one embodiment, a method of making an aqueous humor drainage device for implantation in the eye of a glaucoma patient is made by microfluidics.

The operation method comprises the following steps: the implantation of the surgical instrument not only needs to reduce the harm to the patient as much as possible, but also needs to simplify the operation steps as much as possible and shorten the operation time so as to lighten the burden of a doctor for operation, facilitate the training of the doctor and popularize the drainage instrument. The aqueous humor drainage device adopts an internal implantation mode, is assisted by an ophthalmologic endoscope, and directly injects related product instruments from the anterior chamber (namely the inside of a cornea) through an injector, so that the damage to the external tissues of the eye is avoided, and the aqueous humor is drained from the anterior chamber to the subconjunctival space by the drainage device, thereby being more convenient for postoperative management and intraocular pressure maintenance.

The application example is as follows:

assuming that the patient's Episcleral Venous Pressure (EVP) is 1000Pa and the anterior chamber intraocular pressure is 30mmHg, i.e., about 4000Pa, with the same control variables. The dynamic viscosity of the aqueous humor is 0.00074Pa S, and the density of the aqueous humor is 996kg/m³. XEN is 6mm long and 45um inner diameter. Gradually expand diameter drainage channel drainage ware: the length is 6mm, the inner diameter of the big end is 50um, and the inner diameter of the small end is 40 um. The divergent diameter drainage channel flow diverter was calculated to be 2.13 times the XEN drainage rate.

In light of the foregoing description of the preferred embodiment of the present invention, many modifications and variations will be apparent to those skilled in the art without departing from the spirit and scope of the invention. The technical scope of the present invention is not limited to the content of the specification, and must be determined according to the scope of the claims.

Claims

1. An aqueous humor drainage device for implantation in the eye of a glaucoma patient, comprising: the drainage device is integrally tubular, a drainage channel is formed in the drainage device and used for draining aqueous humor to a filtering tissue, and the drainage channel is an equal-diameter drainage channel or a gradually-enlarged-diameter drainage channel.

2. An aqueous humor drainage device for implantation in the eye of a glaucoma patient according to claim 1 wherein: the drainage channel is an equal-diameter drainage channel, and the diameter of the drainage channel is 0.03-0.3 mm.

3. An aqueous humor drainage device for implantation in the eye of a glaucoma patient according to claim 1 wherein: the drainage channel is a gradually-enlarged diameter drainage channel, the diameter of the large-diameter end of the drainage channel is 0.05mm-0.3mm, and the diameter of the small-diameter end of the drainage channel is 0.03mm-0.15 mm.

4. An aqueous humor drainage device for implantation in the eye of a glaucoma patient according to claim 1 wherein: the axial length of the drainage device is 3-15 mm.

5. An aqueous humor drainage device for implantation in the eye of a glaucoma patient according to claim 1 wherein: the outer diameter of the drainage device is 0.1mm-0.6 mm.

6. An aqueous humor drainage device for implantation in the eye of a glaucoma patient according to claim 1 wherein: the lateral wall of the drainage device is also provided with an auxiliary fixing structure for preventing the drainage device from moving axially.

7. An aqueous humor drainage device for implantation in the eye of a glaucoma patient according to claim 6 wherein: the auxiliary fixing structure is a convex fixing structure or a concave fixing structure.

8. An aqueous humor drainage device for implantation in the eye of a glaucoma patient according to claim 7 wherein: the convex fixing structure is a convex ring, a convex point, a convex rib, a convex piece or a thread bulge which are distributed on the outer side wall of the drainage device.

9. An aqueous humor drainage device for implantation in the eye of a glaucoma patient according to claim 7 wherein: the sunken fixing structure is a concave point, a groove or a sunken thread structure distributed on the outer side wall of the drainage device.

10. An aqueous humor drainage device for implantation in the eye of a glaucoma patient according to claim 1 wherein: the flow diverter is made of biocompatible materials.

11. An aqueous humor drainage device for implantation in the eye of a glaucoma patient according to claim 10 wherein: the biocompatible material is a photo-curable biocompatible material.

12. An aqueous humor drainage device for implantation in the eye of a glaucoma patient according to claim 11 wherein: the photocuring biocompatible material is an epoxy resin (methyl) acrylate material, a polyester (methyl) acrylate material, a polyurethane (methyl) acrylate material, a (methyl) acrylate monomer and a (methyl) acrylate modified natural biomaterial, preferably, triethoxy bisphenol A dimethacrylate, bisphenol A epoxy methacrylate, polyethylene glycol di (methyl) acrylate, a (methyl) acrylate modified gelatin and (methyl) acrylate modified hyaluronic acid.

13. A method for preparing an aqueous humor drainage device implanted in eyes of glaucoma patients is characterized in that: is manufactured in a microfluidic mode.