WO2022268143A1 - 一种用于植入青光眼患者眼内的房水引流器 - Google Patents

一种用于植入青光眼患者眼内的房水引流器 Download PDF

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Publication number
WO2022268143A1
WO2022268143A1 PCT/CN2022/100591 CN2022100591W WO2022268143A1 WO 2022268143 A1 WO2022268143 A1 WO 2022268143A1 CN 2022100591 W CN2022100591 W CN 2022100591W WO 2022268143 A1 WO2022268143 A1 WO 2022268143A1
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Prior art keywords
drainage device
aqueous humor
eyes
implanting
glaucoma
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PCT/CN2022/100591
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English (en)
French (fr)
Inventor
任冬妮
王福乐
殷瑞雪
张洪波
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明澈生物科技(苏州)有限公司
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Publication of WO2022268143A1 publication Critical patent/WO2022268143A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A61F2009/00885—Methods or devices for eye surgery using laser for treating a particular disease
    • A61F2009/00891—Glaucoma

Definitions

  • the invention relates to the field of medical devices, in particular to a drainage device for reducing intraocular pressure of glaucoma patients.
  • glaucoma As a slowly progressive optic neuropathy, glaucoma ranks second in the world's blinding eye diseases and is the leading cause of irreversible blindness.
  • the "China Glaucoma Guidelines (2020)” pointed out that in 2020, the number of glaucoma patients in my country will reach 21 million, and the number of blind people will reach 5.67 million.
  • Its pathogenesis is the accumulation of aqueous humor in the anterior chamber of the eyeball, resulting in an excessive increase in intraocular pressure, which in turn leads to permanent damage to optic nerve cells, and its typical characteristics are optic nerve head damage and corresponding visual field defects.
  • the treatment of glaucoma has always been based on the principle of reducing intraocular pressure, preventing or slowing down the damage of the patient's optic nerve as much as possible, and preserving the existing vision.
  • laser trabeculoplasty can be used for treatment; when laser treatment cannot reduce the intraocular pressure to a safe range or the maximum tolerated drug treatment fails, consider minimally invasive surgery Glaucoma surgery (MIGS); when the above treatment measures fail to achieve the expected results, the more invasive trabeculectomy is finally considered.
  • MIGS minimally invasive surgery Glaucoma surgery
  • the glaucoma surgery method is based on the choice of ensuring the safety of the patient to the greatest extent while controlling the disease without developing or improving. A comparative analysis of current treatment methods is now made.
  • Eye drops In the treatment of glaucoma, commonly used drugs include ⁇ -adrenergic blockers, prostaglandin derivatives, adrenergic receptor agonists, carbonic anhydrase inhibitors, etc. These drugs mainly control intraocular pressure by inhibiting the production of aqueous humor and promoting the drainage of aqueous humor.
  • Drug therapy plays a great role in disease control, but drug therapy also brings many side effects, such as ⁇ -adrenergic blockers can cause slow heart rate, blood pressure drop, and even fainting; the side effects of prostaglandin derivatives are mainly manifested as dripping Local transient burning, tingling, conjunctival hyperemia after medication, long-term medication can increase iris pigmentation, thicken eyelashes, etc.; ⁇ -adrenergic receptor agonists have high allergic reactions, which affect the central nervous system and cause obvious systemic damage. The decrease in arterial pressure also limits its long-term application. In addition, in the long run, drug treatment can only delay the development of the disease, and cannot fundamentally treat glaucoma.
  • SLT Laser trabeculoplasty
  • Biological effects are generated through selective photothermolysis, which activates endothelial cells in trabecular tissue and secretes some cell activity factors, such as IL-1, TNF, etc., to activate trabecular cells.
  • the redifferentiation of the trabecular meshwork cells induces the macrophages in the trabecular meshwork to digest, transport or phagocytize the extracellular substances accumulated in the trabecular meshwork space, thereby remodeling the extracellular matrix of the trabecular meshwork and reducing the resistance of aqueous humor outflow.
  • SLT is non-invasive and easy to operate, it has a low intraocular pressure reduction and short action time, and patients need to seek medical treatment repeatedly, and it is only suitable for early glaucoma.
  • Drainage tube + drainage plate Traditional drainage devices are generally larger, such as Japan Santen The MIDI-Ray pipe produced by Pharmaceutical Co., Ltd has an inner diameter of 0.1mm, an outer diameter of 0.35mm, and a length of 12mm, and a disc structure with a diameter of 7mm is added.
  • This type of surgical instrument has a large trauma area, product exposure, and long-term intraocular pressure fluctuations after surgery, which may last for several months. There are many complications after surgery, including excessive drainage leading to low intraocular pressure, insufficient drainage leading to high intraocular pressure, conjunctival fibrous hyperplasia and blockage at the attachment of the drainage plate, displacement or exposure of the catheter, and obstruction of the inner opening of the catheter, etc.
  • Trabeculectomy is considered the gold standard for surgical treatment of glaucoma. Its principle is to bypass the physiological aqueous humor outflow channel and create a channel for aqueous humor to drain from the anterior chamber to the subconjunctival space. channel, which is proven to be efficient, secure and repeatable. However, there are still some long-term or short-term complications, such as postoperative low intraocular pressure, shallow anterior chamber, choroidal hemorrhage, hyphema, etc. Transient or gradual elevation of intraocular pressure, and in some patients only frequent anti-fibrotic drug injections in the filtering bleb after surgery can guarantee the success of the operation.
  • MIGS minimally invasive glaucoma surgery
  • MIGS refers to improving the outflow of aqueous humor through various methods on the premise of not damaging the conjunctiva and sclera as much as possible, and finally achieving the goal of reducing intraocular pressure.
  • the advantages of MIGS devices are very prominent. Firstly, there is little damage to the tissue, and the postoperative adverse reactions are small.
  • MIGS can be used in patients with open-angle glaucoma or in combination with other surgical methods (phacoemulsification surgery) to treat refractory glaucoma. Or more complicated glaucoma.
  • MIGS is especially suitable for patients with mild to moderate glaucoma. The biggest feature of this surgical method is its good safety. At present, for patients with advanced glaucoma, MIGS alone cannot achieve a good effect, and it needs to be combined with other filtering operations, such as trabeculectomy.
  • Common complications of MIGS include low intraocular pressure, filtering bleb acupuncture, hyphema, etc.
  • MIGS achieves intraocular pressure control in different ways.
  • the first approach is to increase outflow from the trabecular meshwork and schlemm's canal.
  • the trabecular meshwork is considered to be the part with the greatest resistance to aqueous humor outflow. This resistance can be overcome by bypassing or removing this tissue.
  • a trabecular network bypass bracket is placed to avoid the impact of resistance.
  • Another way to bypass trabecular resistance is to go straight to a goniotomy or trabeculotomy.
  • the canal of Schlemm can be dilated with a stent and dilated with viscoelastic.
  • the second approach is to seek to increase outflow through alternative routes, such as by placing a stent into the suprachoroidal space, or by shunting into the subconjunctival space.
  • the third method is to reduce the production of aqueous humor by destroying the tissue that produces it. As in cyclophotocoagulation, a laser probe is inserted through an incision in the clear cornea to ablate the ciliary body.
  • MIGS is widely carried out, mainly based on the following reasons: 1. Compared with traditional glaucoma surgery, the intraocular pressure can be lowered and the complications are less; 2. The patient's treatment effect is better, and the postoperative pain of the patient is greatly reduced 3. Compared with traditional surgery, doctors have a shorter learning curve; 4. The indications are wider, and glaucoma and cataract combined surgery can be performed, and it has a good effect on some refractory and complex glaucoma; 5. Surgery Other traditional glaucoma procedures (such as trabeculectomy or glaucoma drainage implantation) can still be done later. The development of MIGS is mainly based on the following methods:
  • XEN implantation for the treatment of glaucoma its approach and drainage path are: internal implantation, subconjunctival space; the principle of action is: the micro fistula directly connects the anterior chamber and the subconjunctival cavity, increasing the discharge of aqueous humor; structural design features: by Made of glutaraldehyde cross-linked gelatin, the material is soft when exposed to water, 6mm in length, 45mm in inner diameter, and 125mm in outer diameter.
  • the operation is simple, the operation is inserted from the inside of the cornea, that is, the anterior chamber, the incision is small, the invasiveness is small, the subconjunctival incision is not exposed, and there is a high requirement for the positioning of the drainage tube; indications: for moderate to mild open-angle glaucoma, It can be used alone or in combination with cataract phacoemulsification surgery for patients with previous operation failure and a large number of drug treatments ineffective; contraindications: neovascular glaucoma, intraocular or ocular surface In the inflammatory period, limbal stem cell failure and pregnant patients; complications: low intraocular pressure; filtering bleb acupuncture surgery.
  • PRESERFLO Microshunt glaucoma drainage device its entry method and drainage path are: external implantation, subconjunctival space; the principle of action is: directly connect the anterior chamber and subconjunctival cavity, increase the discharge of aqueous humor; structural design features: made of ultra-pure medical Made of grade poly(styrene-block isobutylene-block styrene) with side wings.
  • the Microshunt has a total length of 8.5mm, an inner diameter of the tube of 70um, an outer diameter of 350um, the flanks are 3.1mm from the proximal surface of the tube, the distal surface is 4.4mm, and the wingspan is 1.1mm.
  • iStent implantation its approach and drainage path are: internal implantation, Schlemm's canal; the principle of action is: placed in the trabecular tissue between the iris and cornea, which can connect the anterior chamber and the venous sinus of the sclera, reducing the resistance of aqueous humor drainage , so that the aqueous humor flows into the scleral sinus smoothly; structural design features: surface heparin-coated titanium stent, weighing about 60 micrograms, 120 microns inner diameter, 0.5mm ⁇ 0.25mm ⁇ 1.0mm. Precisely processed, the outlet of the flow channel is not a single outlet, and there are four auxiliary outlets.
  • the concave waist design in the middle is convenient for the device to fit and fix with the tissue; indications: for the treatment of mild to moderate primary open-angle glaucoma in adults; contraindications: Angle-closure glaucoma, neovascular glaucoma, rapid increase in intraocular pressure, ocular inflammation, and diseases that cause superior scleral venous hypertension, such as goiter, ocular tumors, S-W syndrome; irregular anterior chamber angle shape; complications : Stent dislocation, occlusion, hyphema.
  • Hydrus implantation its approach and drainage path are: internal implantation, Schlemm canal; the principle of action is: to expand the scleral venous sinus, reduce the resistance of aqueous humor drainage; structural design features: nickel-titanium alloy, about 8mm in length , the radial dimension is about 240um.
  • the structure is not easily deformed, and the stent is directly placed in the Schlemm's tube; indications: for the treatment of patients with mild to moderate primary open-angle glaucoma combined with cataract surgery, patients with pseudoexfoliation glaucoma; contraindications: angle-closure glaucoma, following Onset glaucoma, such as neovascular, uveitis, traumatic, steroid-induced, and lens-induced glaucoma, glaucoma with previous ciliary body or scleral sinus trauma such as cycloablation, trabeculectomy Patients; complications: hyphema, nickel ion vascular wall toxicity, corneal punctate staining, corneal epithelial erosion, stromal edema, tissue adhesion.
  • Onset glaucoma such as neovascular, uveitis, traumatic, steroid-induced, and lens-induced glaucoma, glaucoma with previous ciliary body or s
  • CyPass micro-stent treatment its approach and drainage path are: suprachoroidal space; structural design features: polyamide; indications: adults, mild to moderate primary open-angle glaucoma POAG, combined with cataract; contraindications: primary Glaucoma other than open-angle glaucoma, the angle of the chamber is irregular; complications: FDA Class I highest level of recall, which may lead to disability or death.
  • XEN glutaraldehyde-crosslinked gelatin, which has good flexibility and biocompatibility.
  • the surgical method is implanted in the cornea, which greatly reduces the risk of external infection of the cornea. Its simple surgical operation method, The smooth structural shape and reasonable inner diameter can reduce the pain of patients and at the same time have a good effect on intraocular pressure control.
  • XEN can also be used for refractory glaucoma, special glaucoma patients who are intolerant to drugs, and can be used in combination with cataract phacoemulsification to treat some patients with angle-closure glaucoma. From the perspective of drainage path, although Cypass drainage to the suprachoroidal space can avoid the management of postoperative filtering blebs, the product has been recalled globally, and its drainage risk needs to be demonstrated. Overall, XEN is currently the MIGS product with the most obvious comprehensive advantages.
  • the object of the present invention is to provide an aqueous humor drainage device for implanting in the eyes of glaucoma patients, the drainage device has high drainage efficiency clinically and significantly reduces intraocular pressure.
  • the technical solution of the present invention is: an aqueous humor drainage device for implanting in the eyes of glaucoma patients, the drainage device is in the shape of a tube as a whole, and a drainage channel is formed in it, which is used to drain the aqueous humor to the filtering tissue.
  • the above-mentioned drainage channel is a drainage channel with an equal diameter or a drainage channel with a gradually expanding diameter.
  • the drainage channel is an equal-diameter drainage channel, and the diameter of the drainage channel is 0.03-0.3 mm.
  • the drainage channel is a drainage channel with a gradually expanding diameter, the diameter of the large-diameter end of the drainage channel is 0.05mm-0.3mm, and the diameter of the small-diameter end is 0.03mm-0.15mm.
  • the axial length of the diverter is 3-15mm.
  • the outer diameter of the flow guide is 0.1mm-0.6mm.
  • the outer wall of the flow guide is further provided with an auxiliary fixing structure for preventing the flow guide from moving axially.
  • the auxiliary fixing structure is a convex fixing structure or a concave fixing structure.
  • the protrusion fixing structure is a protruding ring, protruding point, protruding rib, lug or thread protruding distributed on the outer wall of the flow guide.
  • the recessed fixing structure is a recessed point, a groove or a recessed thread structure distributed on the outer wall of the flow guide.
  • the drainage device is made of biocompatible materials.
  • the biocompatible material is a photocurable biocompatible material.
  • the photocurable biocompatible material is epoxy resin (meth)acrylate material, polyester (meth)acrylate material, polyurethane (meth)acrylate material, (meth) Acrylate monomers, (meth)acrylate modified natural biomaterials, preferably triethoxylated bisphenol A dimethacrylate, bisphenol A epoxy methacrylate, polyethylene glycol di(meth) base) acrylate, (meth)acrylate modified gelatin, (meth)acrylate modified hyaluronic acid.
  • epoxy resin (meth)acrylate material polyester (meth)acrylate material, polyurethane (meth)acrylate material, (meth) Acrylate monomers, (meth)acrylate modified natural biomaterials, preferably triethoxylated bisphenol A dimethacrylate, bisphenol A epoxy methacrylate, polyethylene glycol di(meth) base) acrylate, (meth)acrylate modified gelatin, (meth)acrylate modified hyaluronic acid.
  • the invention discloses a preparation method of an aqueous humor drainage device used for implanting in the eyes of glaucoma patients, which is manufactured in a microfluidic manner.
  • An aqueous humor drainage device for implanting in the eyes of glaucoma patients according to the present invention has a circular cross-section.
  • the shape coefficient of the circular shape is the smallest.
  • the area of the circle is the largest, and the outer surface of the circle is less irritating to the tissue, and the smooth surface can significantly reduce the anterior chamber hemorrhage, so the circular section is selected as the final section selection.
  • the drainage channel adopts a gradually expanding diameter, compared with the equal diameter tubes of XEN, PRESERFLO Microshunt and other products, the gradually expanding diameter drainage channel provides directional drainage As the diameter of the tube increases, the flow rate decreases and the pressure increases, so that the aqueous humor is discharged to the subconjunctival space at a faster rate, so it has a higher initial drainage efficiency; on the contrary, the pressure decreases and the flow rate increases. Atrial pressure is higher, so it can hinder the generation of reflux.
  • the diameter of the large-diameter end of the drainage channel with a gradually expanding diameter is 0.05mm-0.3mm
  • the diameter of the small-diameter end is 0.03mm-0.15mm
  • the diameter of the pipeline is The smaller the IOP, the lower the probability of hypoocular pressure, but the smaller the diameter of the tube, on the one hand, cell debris and blood clots are likely to block the tube, on the other hand, the treatment effect and drainage efficiency will be reduced; from the design point of view Look, for the prevention and treatment of low intraocular pressure, on the one hand, it is necessary to carefully select the size of the inner diameter, and on the other hand, it is necessary to reasonably select the shape of the lumen to suppress the occurrence of low intraocular pressure.
  • the anterior chamber pressure when the anterior chamber pressure is too low, the anterior chamber The pressure difference between the chamber and the filter bleb decreases, which reduces the discharge rate.
  • the flow rate decreases and the pressure tends to increase (the pressure along the equal-diameter tube remains constant), so The inherently low anterior chamber pressure suppresses the tendency for pressure to rise, and this suppression prevents hypotension more easily than with isodiametric conduits.
  • An aqueous humor drainage device for implantation in the eyes of glaucoma patients of the present invention has a simple and smooth structure, fewer accessories, and less invasive effect on tissues; and adopts microfluidic control and mold turning technology, Optimize the processing technology, improve production efficiency, and facilitate mass production.
  • Fig. 1 is the cross-sectional view of the diverter of embodiment 1 of the present invention
  • Fig. 2 is the cross-sectional view of the diverter of Embodiment 2 of the present invention.
  • Figure 3 shows that the auxiliary fixing structure on the outer wall of the diverter is a convex ring that is evenly distributed;
  • Fig. 4 shows that the auxiliary fixing structure of the outer wall of the diverter is a convex ring arranged at the end;
  • Figure 5 shows that the auxiliary fixing structure on the outer wall of the diverter is uniformly distributed bumps
  • Figure 6 shows the auxiliary fixing structure of the outer wall of the diverter as a bump set at the end
  • Figure 7 shows that the auxiliary fixing structure on the outer wall of the diverter is evenly distributed ribs
  • Figure 8 shows that the auxiliary fixing structure of the outer wall of the diverter is the tabs (two pieces) arranged on both sides of the side wall of the diverter;
  • Figure 9 is the auxiliary fixing structure of the outer wall of the diverter, which is the tabs (multiple) provided on both sides of the side wall of the diverter
  • Figure 10 shows that the auxiliary fixing structure on the outer wall of the flow guide is evenly distributed thread protrusions (small pitch);
  • Figure 11 shows that the auxiliary fixing structure on the outer wall of the diverter is evenly distributed thread protrusions (large pitch);
  • Figure 12 shows that the auxiliary fixing structure of the outer wall of the flow guide is a threaded protrusion arranged at the end;
  • Figure 13 shows that the auxiliary fixing structure on the outer wall of the diverter is evenly distributed concave points
  • Fig. 14 shows that the auxiliary fixing structure of the outer wall of the flow guide is a groove arranged at the end;
  • Figure 15 shows that the auxiliary fixing structure of the outer wall of the flow guide is provided with a concave thread at the end.
  • an aqueous humor drainage device for implanting in the eyes of glaucoma patients, the drainage device 1 is in the shape of a tube as a whole, and a drainage channel 2 is formed in it, which is used to drain the aqueous humor to the filtering tissue, and the drainage channel 2 is equal diameter drainage channel.
  • the diameter of the drainage channel 1 is 0.03-0.3 mm.
  • the axial length of the diverter is 3-15mm.
  • the axial length of the diverter can be adjusted according to the actual situation.
  • an aqueous humor drainage device for implanting in the eyes of glaucoma patients, the drainage device 1 is in the shape of a tube as a whole, and a drainage channel 2 is formed in it, which is used to drain the aqueous humor to the filtering tissue, and the drainage channel 2 is the gradually expanding diameter drainage channel.
  • the maximum diameter of the drainage channel 2 is not more than 0.3 mm, and the minimum diameter is not less than 0.03 mm.
  • 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-0.15mm.
  • the diameter of the large-diameter end of the drainage channel 2 is 0.05mm-0.15mm, and the diameter of the small-diameter end is 0.04mm-0.06mm, which can realize an initial flow rate of 3.5-15 times the rate of aqueous humor production. Dual regulation of venous pressure and pipeline resistance can effectively suppress hypotension.
  • the axial length of the diverter is 3-15mm.
  • the axial length of the drainage device can be adjusted according to the actual situation to select a suitable drainage rate.
  • Embodiment 1 the outer wall of the flow guide is also provided with an auxiliary fixing structure 3 for preventing the axial movement of the flow guide, wherein the auxiliary fixing structure 3 is distributed on the outer wall of the flow guide rings, bumps, ribs, tabs or threaded projections.
  • the auxiliary fixing structure 3 is a protruding ring distributed on the outer wall of the flow guide, wherein the protruding rings can be evenly distributed or non-uniformly distributed.
  • the auxiliary fixing structure 3 is a raised point distributed on the outer wall of the flow guide, wherein the raised points can be evenly distributed on the axial side wall of the flow guide, or can be distributed on one end of the side wall of the flow guide , can also be distributed anywhere on the side wall of the diverter.
  • the auxiliary fixing structure 3 is ribs distributed on the outer wall of the flow guide, wherein the ribs may be evenly distributed in the circumferential direction of the flow guide, or may be a single rib of course.
  • the auxiliary fixing structure 3 is a protruding piece distributed on the outer wall of the flow guide, wherein the protruding piece can be a single piece or a plurality of pieces.
  • the auxiliary fixing structure 3 is a thread protrusion distributed on the outer wall of the flow guide, wherein the pitch of the thread protrusion can be selected according to the actual situation, and the thread protrusion structure can also be arranged on One end or the middle part of the outer wall of the diverter.
  • Example 4
  • Embodiment 1 Others are the same as in Embodiment 1 or Embodiment 2, except that the outer wall of the flow guide is also provided with an auxiliary fixing structure 3 for preventing the axial movement of the flow guide, wherein the auxiliary fixing structure 3 is distributed on the outer wall of the flow guide Dimple, groove or concave thread structure.
  • the auxiliary fixing structure 3 is dimples distributed on the outer wall of the flow guide, wherein the dimples can be evenly distributed or non-uniformly distributed.
  • the auxiliary fixing structure 3 is a groove distributed on the outer wall of the flow guide, wherein there may be one or more grooves.
  • the auxiliary fixing structure 3 is a recessed thread structure distributed on the outer wall of the flow guide, wherein the pitch of the recessed thread structure can be selected according to the actual situation, and the recessed thread structure can also be arranged on one end of the outer wall of the flow guide or middle part.
  • the diverter is made of biocompatible materials, specifically epoxy acrylate materials, polyester acrylate materials, Bis-GMA, SR348, PEGDA, PEGDMA, GelMA or HAMA.
  • a preparation method of an aqueous humor drainage device for implanting in the eyes of glaucoma patients is manufactured by using a microfluidic method.
  • Surgical method The implantation of surgical instruments should not only minimize the harm to the patient, but also simplify the operation steps as much as possible and shorten the operation time to reduce the burden on the operating doctors, facilitate the training of doctors, and promote the promotion of drainage devices.
  • the aqueous humor drainage device of the present invention is implanted in an internal way, and is assisted by an ophthalmic endoscope, and directly injects related products and instruments from the anterior chamber (that is, the inside of the cornea) through a syringe, thereby avoiding damage to the external tissues of the eye, and the drainage device drains the aqueous humor From the anterior chamber drainage to the subconjunctival space, it is more convenient for postoperative management and intraocular pressure maintenance.
  • the patient's episcleral venous pressure (EVP) is set to 1000Pa, and the anterior chamber intraocular pressure is 30mmHg, which is about 4000pa.
  • the dynamic viscosity of aqueous humor is 0.00074Pa*S, and the density of aqueous humor is 996kg/m 3 .
  • XEN length 6mm, inner diameter 45um. Drainage device with gradually expanding diameter drainage channel: length 6mm, inner diameter of the large end 50um, and inner diameter of the small end 40um. According to the calculation, the diversion rate of drainage channel with increasing diameter is 2.13 times of that of XEN.

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Abstract

一种用于植入青光眼患者眼内的房水引流器（1），引流器（1）整体呈管状，其内形成有引流通道（2），用于将房水引流至滤过组织，引流通道（2）为等直径引流通道或渐扩直径引流通道。房水引流器（1）由生物相容性良好的材料制成，临床上引流效率高，眼压降低显著，通过采用微流控与翻模技术，优化加工工艺，提高生产效率，便于批量化生产。

Description

一种用于植入青光眼患者眼内的房水引流器 技术领域
本发明涉及医疗器械领域，尤其涉及一种用于降低青光眼患者眼内压的引流器械。
 背景技术
青光眼作为一种缓慢进展的视神经病变，排在全世界致盲性眼病的第二位，是不可逆性致盲的首要原因。《中国青光眼指南（2020）》指出我国2020年青光眼患者将达到2100万，致盲人数达567万。其发病机理是房水在眼球前房积聚，造成眼压过度升高，进而导致视神经细胞永久损伤，其典型的特点为视乳头损伤和相应的视野缺损。对于青光眼的治疗一直以来以降低眼内压，尽可能的预防或减缓患者视神经的损害，保存现有视力为原则。当传统药物治疗效果不佳，或患者不能耐受长期用药，可使用激光小梁成形术治疗；当激光治疗也无法使眼压降至安全范围或者最大耐受药物治疗失败时，考虑进行微创青光眼手术（MIGS）；当以上治疗措施都不能起到预想结果时，最后考虑创伤性较大的小梁切除术。总之青光眼手术方式，是根据在控制住病情不发展或者好转的情况下，最大程度上保证患者的安全所作出的选择。现对目前治疗方式做出对比分析。
1）眼滴液：在青光眼治疗中，常用药物有β肾上腺能阻滞剂，前列腺素衍生剂，肾上腺能受体激动剂，碳酸酐酶抑制剂等。这些药物主要通过抑制房水产生和促进房水排出来控制眼压的。药物治疗对病情控制起着很大作用，但是药物治疗却也带来很多副作用，如β肾上腺能阻滞剂可导致心率过缓，血压下降，甚至昏厥；前列腺素衍生剂的副作用主要表现为滴药后局部短暂性烧灼，刺痛，结膜充血，长期用药使虹膜色素增加，睫毛增粗等；α肾上腺受体激动剂有较高的过敏性反应，对中枢神经系统的影响和引起明显的全身动脉压降低也限制了其长期应用。此外长期来看，药物治疗只能延缓病情的发展，并不能从根本上治疗青光眼。
2）激光小梁成形术（SLT）：通过选择性光热解作用产生生物学效应，使小梁组织内的内皮细胞激活，并分泌一些细胞活性因子，如IL-1、TNF等，激活小梁网细胞再分化，诱导小梁网内的巨噬细胞对小梁网间隙淤积的细胞外物质发挥消化转运或吞噬作用，从而重塑小梁网细胞外基质，降低房水外流阻力。SLT虽然无创，操作简单，但是眼压降低幅度低，起作用时间短，患者需要反复就医，且只适用于早期青光眼。
3）引流管+引流板：传统引流器一般体积较大，如日本Santen Pharmaceutical Co., Ltd公司生产的the MIDI-Ray管道内径0.1mm，外径0.35mm，长12mm，另外附加一个直径达7mm的圆盘结构。这类手术器械创伤面积较大、产品暴露且术后会经过很长时间的眼压波动，这种波动可能会持续数月。手术后并发症较多，包括过度引流导致眼压过低、引流不足导致眼压高, 引流板附件结膜纤维增生阻塞,导管移位或外露及导管内口阻塞等等。
4）小梁切除术：小梁切除手术（trabeculectomy，TE）被认为是青光眼手术治疗的金标准，其原理是绕过生理的房水流出通道，创造一个房水从前房引流至结膜下空间的通道，它被证明是有效、安全且可重复的。但仍存在一些长期或短期的并发症，早期阶段如术后低眼压、浅前房、脉络膜出血，前房积血等，长期阶段如加重白内障，滤过泡炎、滤过泡瘢痕化导致短暂或渐进性的眼压升高，并且部分患者只有术后频繁的行滤过泡抗纤维化药物注射才能保证手术的成功。
5）MIGS微创手术：微创青光眼手术（MIGS）一词，始于2008年左右，首个MIGS器械istent在2012年拿到FDA注册。如今MIGS已成为眼科的常见说法，在青光眼患者的治疗中起着越来越重要的作用。MIGS是指在尽量不损伤结膜和巩膜的前提下，通过各种方法改善房水外流，最终达到降低眼压的目的。MIGS器械的优势是十分突出的，首先对组织破坏很小，术后不良反应较小，用于开角型青光眼患者或者与其他手术方式（白内障超声乳化手术）联用可用于治疗难治性，或者病情较为复杂的青光眼。MIGS尤其适合轻中度青光眼患者，该手术方式的最大特点是具有良好的安全性。目前对于晚期青光眼患者，MIGS单独作用并不能起到很好的效果，需要结合其他滤过性手术进行治疗，如小梁切除术等。MIGS常见的并发症有，低眼压，滤过泡针刺，前房出血等。
MIGS通过不同的方式实现眼压的控制。第一种方法是增加小梁网和schlemm管的流出量。传统上认为小梁网是房水流出阻力最大的部位。这种阻力可以通过旁路或移除这种组织来克服。比如放置小梁网旁路支架来实现规避阻力影响。另一种绕过小梁网阻力的方法是直接进行房角切开术或小梁切开术。另外可通过支架扩张schlemm管并用粘弹剂扩张。第二种方法是寻求通过替代途径增加流出量，比如通过放置支架进入脉络膜上腔，或者分流到结膜下间隙。 第三种方法是破坏房水产生的组织来减少房水的产生。如睫状体光凝术，激光探针通过透明角膜切口插入，用于消融睫状体。
MIGS得到广泛开展，主要基于以下几个原因：1.与传统青光眼手术相比，眼压能降得更低，并发症更少；2.患者治疗效果更好,极大减轻患者术后的疼痛与不适；3.与传统术式相较，医生具有更短的学习曲线；4.适应症更广，能施行青光眼白内障联合手术，对部分难治性，复杂性青光眼有良好效果；5.手术以后仍可施行其他传统青光眼手术（如小梁切除术或者青光眼引流物植入）。MIGS的开展，主要基于以下方式：
XEN植入治疗青光眼，其入路方式及引流路径为：内路植入，结膜下间隙；作用原理为：微型瘘管直接连通前房与结膜下空腔，增加房水排出；结构设计特点：由戊二醛交联明胶制成，材质遇水柔软，长6mm，内径45mm，外径125mm。手术操作简单，从角膜内部即前房插入，创口小，侵入性小，没有暴露结膜下切口，对引流管的定位放置有着很高的要求；适应症：用于中轻度开角型青光眼，包括既往手术失败，大量药物治疗无效者，可单独使用，也可与白内障超声乳化手术联合用于难治性青光眼，部分闭角型青光眼患者；禁忌症：新生血管性青光眼，眼内或者眼表处于炎症期，角膜缘干细胞衰竭和妊娠期患者；并发症：低眼压；滤过泡针刺手术。
PRESERFLO Microshunt青光眼引流器，其入路方式及引流路径为：外路植入，结膜下间隙；作用原理为：直接连通前房与结膜下空腔，增加房水排出；结构设计特点：由超纯医用级聚(苯乙烯-嵌段异丁烯-嵌段苯乙烯)制成,带侧翼结构。Microshunt全长8.5mm，管内径70um，外径350um，侧翼距离管近端面3.1mm,远端面4.4mm，翼展1.1mm。植入时从外部做切口插入到前房，需要对结膜进行剥离，具有一定的侵入性伤害，但是外部操作使手术更加简单；适应症：原发性开角型青光眼，最大耐受药物治疗后仍不可控的眼压和/或因青光眼进展而必须接受手术的患者，部分难治性青光眼患者，或可能在虹膜角膜内皮细胞综合征、葡萄膜炎性青光眼和新生血管性青光眼等疾病中发挥作用；禁忌症：不适用于闭角型青光眼，先前滤过手术失败患者；并发症：低眼压；滤过泡针刺手术。
iStent植入术，其入路方式及引流路径为：内路植入，Schlemm管；作用原理为：放在虹膜、角膜间小梁组织，可以连接前房和巩膜静脉窦，减少房水排出阻力，使房水顺利流入巩膜静脉窦；结构设计特点：表面肝素涂层的钛支架，重约60微克，120微米内径，0.5mm×0.25mm×1.0mm。精密加工，流道出口非单一出口，另设四个辅助出口，中部凹腰设计便于器械与组织贴合固定；适应症：用于治疗成人轻中度原发性开角型青光眼；禁忌症：闭角型青光眼，新生血管性青光眼，眼压迅速升高，眼部炎症，以及引起上巩膜静脉高压的疾病，如甲状腺肿，眼部肿瘤，s-w综合征；前房角形状不规则；并发症：支架错位，闭塞，前房积血。
Hydrus植入术，其入路方式及引流路径为：内路植入，Schlemm管；作用原理为：撑大巩膜静脉窦，减小房水排出阻力；结构设计特点：镍钛合金，长约8mm，径向尺寸约240um。结构不易变形，支架直接置于Schlemm's管；适应症：用于治疗轻中度原发性开角型青光眼合并白内障手术治疗的患者,假性剥脱性青光眼患者；禁忌症：闭角型青光眼，继发性青光眼，如新生血管性、葡萄膜炎、创伤性、类固醇诱导性和晶状体诱导性青光眼，此前接受过睫状体消融术、小梁切除术等睫状体或巩膜静脉窦受创的青光眼患者；并发症：前房积血，镍离子血管壁毒性，角膜点状染色、角膜上皮侵蚀、基质水肿，组织粘连。
CyPass微型支架治疗，其入路方式及引流路径为：脉络膜上腔；结构设计特点：聚酰胺；适应症：成人，轻中度原发性开角型青光眼POAG，合并白内障；禁忌症：原发性开角型青光眼以外其他青光眼，房角形状不规则；并发症：FDA Class I 最高等级召回，可能至伤残或死亡。
综合来看，不同产品都有各自的特点与不同的适应症范围。从入路方式来看，内路植入相对于外路植入对组织的破坏更小。XEN采用戊二醛交联的明胶制成，其具有良好的柔韧性和生物相容性，手术方式采用角膜内路植入，极大地减少了角膜外部感染的风险，其简易的手术操作方式，流畅的结构外形，合理的内径尺寸在减轻病人痛苦的同时，能够起到良好的眼压控制效果。此外，XEN还可用于难治性青光眼，药物不耐受的特殊青光眼患者，与白内障超声乳化手术联用可治疗部分闭角型青光眼患者。从引流路径来看，Cypass引流到脉络膜上腔虽然可以避免术后滤过泡的管理，但目前该产品已被全球召回，其引流风险有待论证。总体来看XEN是目前综合优势最明显的MIGS产品。
 技术问题
本发明的目的在于提供一种用于植入青光眼患者眼内的房水引流器，该引流器临床上引流效率高,眼压降低显著。
 技术解决方案
本发明的技术方案是：一种用于植入青光眼患者眼内的房水引流器，所述引流器整体呈管状，其内形成有引流通道，用于将房水引流至滤过组织，所述引流通道为等直径引流通道或渐扩直径引流通道。
作为优选，所述引流通道为等直径引流通道，所述引流通道的直径为0.03-0.3mm。
作为优选，所述引流通道为渐扩直径引流通道，引流通道大径端直径为0.05mm-0.3mm，小径端直径为0.03mm-0.15mm。
作为优选，所述引流器轴向长度为3-15mm。
作为优选，所述引流器的外径为0.1mm-0.6mm。
作为优选，所述引流器外侧壁还设有辅助固定结构，用于防止引流器轴向移动。
作为优选，所述辅助固定结构为凸起固定结构或为凹陷固定结构。
作为优选，所述凸起固定结构为分布在引流器外侧壁的凸环、凸点、凸棱、凸片或螺纹凸起。
作为优选，所述凹陷固定结构为分布在引流器外侧壁的凹点、凹槽或凹陷螺纹结构。
作为优选，所述引流器由生物相容性材料制成。
作为优选，所述生物相容性材料为光固化生物相容性材料。
作为优选，所述光固化生物相容性材料为环氧树脂（甲基）丙烯酸酯类材料、聚酯（甲基）丙烯酸酯类材料、聚氨酯（甲基）丙烯酸酯类材料、（甲基）丙烯酸酯类单体、（甲基）丙烯酸酯改性天然生物材料，优选地，三乙氧化双酚A二甲基丙烯酸酯、双酚A环氧甲基丙烯酸酯、聚乙二醇二（甲基）丙烯酸酯、（甲基）丙烯酸酯改性明胶、(甲基)丙烯酸酯改性透明质酸。
一种用于植入青光眼患者眼内的房水引流器的制备方法，采用微流控方式制造。
 有益效果
（1）本发明的一种用于植入青光眼患者眼内的房水引流器，其截面采用的是圆形，在所有不同横截面形状当中圆形的体形系数最小，相同的周长所围成的面积以圆形最大，圆形外表面对组织刺激较小,圆滑的曲面能明显减小前房出血,因此选择圆形截面作为最终的截面选择。
（2）本发明的一种用于植入青光眼患者眼内的房水引流器，引流通道采用渐扩直径，相对于XEN,PRESERFLO Microshunt等产品的等直径管道，渐扩直径引流通道提供定向引流作用，随着管道直径的增加，流速降低，压力升高，使房水以更快的速率排向结膜下间隙,因此具有更高的初始引流效率；反之，则压力降低，流速增加，由于前房压力较高，因此能阻碍回流的产生。
（3）本发明的一种用于植入青光眼患者眼内的房水引流器，渐扩直径引流通道大径端直径为0.05mm-0.3mm，小径端直径为0.03mm-0.15mm，管道直径越小，低眼压出现的概率越低，但管道直径越小，一方面细胞碎屑，血凝块容易对管道造成阻塞，另一方面，治疗效果与引流效率都会降低；从设计的角度来看，对于低眼压的防治，一方面要慎重选择内径尺寸，另一方面要通过合理选择管腔形状抑制低眼压发生，从渐扩引流通道直径来看，前房压力过低时，前房与滤过泡压差降低，这使排放速率降低，此外，随着渐扩直径引流通道引流器直径的增加，流速降低，压力趋向于升高（等直径管沿程压力不变），因前房压力本身较低，会抑制压力升高的趋势，相对于等直径管道，这种抑制会更容易防止低眼压的发生。
（4）本发明的一种用于植入青光眼患者眼内的房水引流器，结构简单流畅，辅件较少，对组织有较小的侵入影响；且采用微流控与翻模技术，优化加工工艺，提高生产效率，便于批量化生产。
 附图说明
下面结合附图和实施例对本发明进一步说明。
图1是本发明实施例1的引流器剖面图；
图2是本发明实施例2的引流器剖面图；
图3是引流器外侧壁的辅助固定结构为均匀分布的凸环；
图4是引流器外侧壁的辅助固定结构为设置在端部的凸环；
图5是引流器外侧壁的辅助固定结构为均匀分布的凸点；
图6是引流器外侧壁的辅助固定结构为设置在端部的凸点
图7是引流器外侧壁的辅助固定结构为均匀分布的凸棱；
图8是引流器外侧壁的辅助固定结构为设置在引流器侧壁两侧的凸片（设有两个）；
图9是引流器外侧壁的辅助固定结构为设置在引流器侧壁两侧的凸片（设有多个）
图10是引流器外侧壁的辅助固定结构为均匀分布的螺纹凸起（小螺距）；
图11是引流器外侧壁的辅助固定结构为均匀分布的螺纹凸起（大螺距）；
图12是引流器外侧壁的辅助固定结构为设置在端部的螺纹凸起；
图13是引流器外侧壁的辅助固定结构为均匀分布的凹点；
图14是引流器外侧壁的辅助固定结构为设置在端部的凹槽；
图15是引流器外侧壁的辅助固定结构为设置在端部凹陷螺纹。
图中： 1.引流器，2.引流通道，3.辅助固定结构。
 本发明的实施方式
现在结合附图对本发明作进一步详细的说明。这些附图均为简化的示意图，仅以示意方式说明本发明的基本结构，因此其仅显示与本发明有关的构成。
实施例1
如图1所示，一种用于植入青光眼患者眼内的房水引流器，引流器1整体呈管状，其内形成有引流通道2，用于将房水引流至滤过组织，引流通道2为等直径引流通道。
在一种具体实施方式中，引流通道1的直径为0.03-0.3mm。
在一种具体实施方式中，引流器轴向长度为3-15mm。可以根据实际情况进行调整引流器的轴向长度。
实施例2
如图2所示，一种用于植入青光眼患者眼内的房水引流器，引流器1整体呈管状，其内形成有引流通道2，用于将房水引流至滤过组织，引流通道2为渐扩直径引流通道。
在一种具体实施方式中，引流通道2最大直径不超过0.3mm，最小直径不低于0.03mm。 其中，引流通道2大径端直径为0.05mm-0.3mm，小径端直径为0.03mm-0.15mm。作为优选，引流通道2大径端直径为0.05mm-0.15mm，小径端直径为0.04mm-0.06mm，可实现初始流量为房水产生速率的3.5-15倍,在此范围,通过引流目标组织静脉压与管道阻力双重调节能有效抑制低眼压。 
在一种具体实施方式中，引流器轴向长度为3-15mm。可以根据实际情况进行调整引流器的轴向长度，以选择合适的引流速率。
实施例3
其他同实施例1或实施例2，不同之处在于，引流器外侧壁还设有还包括辅助固定结构3，用于防止引流器轴向移动，其中辅助固定结构3为分布在引流器外侧壁的凸环、凸点、凸棱、凸片或螺纹凸起。
如图3和图4所示，辅助固定结构3为分布在引流器外侧壁的凸环，其中凸环可以是均匀分布，也可以是非均匀分布。
如图5和图6所示，辅助固定结构3为分布在引流器外侧壁的凸点其中凸点可以是均匀分布在引流器轴向侧壁的，也可以是分布在引流器侧壁的一端，也可以是分布在引流器侧壁的任一地方。
如图7所示，辅助固定结构3为分布在引流器外侧壁的凸棱，其中凸棱可以是均匀分布在引流器周向的凸棱，当然也可以是单根凸棱。
如图8和图9所示，辅助固定结构3为分布在引流器外侧壁的凸片，其中凸片可以是单片，也可以是多片。
如图10、图11和图12所示，辅助固定结构3为分布在引流器外侧壁的螺纹凸起，其中螺纹凸起的螺距可以根据实际情况进行选择，螺纹凸起结构也可以是设置在引流器外侧壁的一端或者中部。实施例4
其他同实施例1或实施例2，不同之处在于，引流器外侧壁还设有还包括辅助固定结构3，用于防止引流器轴向移动，其中辅助固定结构3为分布在引流器外侧壁的凹点、凹槽或凹陷螺纹结构。
如图13所示，辅助固定结构3为分布在引流器外侧壁的凹点，其中凹点可以是均匀分布，也可以是非均匀分布。
如图14所示，辅助固定结构3为分布在引流器外侧壁的凹槽，其中凹槽可以是一个，也可以是多个。
如图15所示，辅助固定结构3为分布在引流器外侧壁的凹陷螺纹结构，其中凹陷螺纹结构的螺距可以根据实际情况进行选择，凹陷螺纹结构也可以是设置在引流器外侧壁的一端或者中部。
在一种具体实施方式中，引流器由生物相容性材料制成，具体为环氧树脂丙烯酸酯类材料、聚酯丙烯酸酯类材料、 Bis-GMA、SR348、PEGDA、PEGDMA、GelMA或HAMA。
在一种具体实施方式中，一种用于植入青光眼患者眼内的房水引流器的制备方法，采用微流控方式制造。
手术方法：手术器械植入不仅要把对患者的伤害尽量降低，而且要尽量简化手术操作步骤，缩短手术操作时间，以减轻手术操作医生的负担，便于医生的培训，以及引流器械的推广。本发明的房水引流器采用内路植入方式，通过眼科内窥镜辅助，从前房（即角膜内部）通过注射器直接注射相关产品器械，从而避免对眼睛外部组织的损伤，引流器把房水从前房引流到结膜下间隙，这样更加便于术后的管理与眼压维护。
应用实施例：
在控制变量相同情况下，设患者巩膜外静脉压（EVP）为1000Pa，前房眼压30mmHg，即约4000pa。房水动力粘度为0.00074Pa*S，房水密度996kg/m 3。XEN:长6mm，内径45um。渐扩直径引流通道引流器：长6mm，大端内径50um，小端内径40um。通过计算渐扩直径引流通道引流器是XEN引流速率的2.13倍。
以上述依据本发明的理想实施例为启示，通过上述的说明内容，相关工作人员完全可以在不偏离本项发明技术思想的范围内，进行多样的变更以及修改。本项发明的技术性范围并不局限于说明书上的内容，必须要根据权利要求范围来确定其技术性范围。

Claims (11)

  1. 一种用于植入青光眼患者眼内的房水引流器，其特征在于：所述引流器整体呈管状，其内形成有引流通道，用于将房水引流至滤过组织，所述引流通道为渐扩直径引流通道，引流通道大径端直径为0.05mm-0.3mm，小径端直径为0.03mm-0.15mm。
  2. 如权利要求1所述的一种用于植入青光眼患者眼内的房水引流器，其特征在于：所述引流器轴向长度为3-15mm。
  3. 如权利要求1所述的一种用于植入青光眼患者眼内的房水引流器，其特征在于：所述引流器的外径为0.1mm-0.6mm。
  4. 如权利要求1所述的一种用于植入青光眼患者眼内的房水引流器，其特征在于：所述引流器外侧壁还设有辅助固定结构，用于防止引流器轴向移动。
  5. 如权利要求4述的一种用于植入青光眼患者眼内的房水引流器，其特征在于：所述辅助固定结构为凸起固定结构或为凹陷固定结构。
  6. 如权利要求5述的一种用于植入青光眼患者眼内的房水引流器，其特征在于：所述凸起固定结构为分布在引流器外侧壁的凸环、凸点、凸棱、凸片或螺纹凸起。
  7. 如权利要求6所述的一种用于植入青光眼患者眼内的房水引流器，其特征在于：所述凹陷固定结构为分布在引流器外侧壁的凹点、凹槽或凹陷螺纹结构。
  8. 如权利要求1所述的一种用于植入青光眼患者眼内的房水引流器，其特征在于：所述引流器由生物相容性材料制成。
  9. 如权利要求8所述的一种用于植入青光眼患者眼内的房水引流器，其特征在于：所述生物相容性材料为光固化生物相容性材料。
  10. 如权利要求9所述的一种用于植入青光眼患者眼内的房水引流器，其特征在于：所述光固化生物相容性材料为环氧树脂（甲基）丙烯酸酯类材料、聚酯（甲基）丙烯酸酯类材料、聚氨酯（甲基）丙烯酸酯类材料、（甲基）丙烯酸酯类单体、（甲基）丙烯酸酯改性天然生物材料，优选地，三乙氧化双酚A二甲基丙烯酸酯、双酚A环氧甲基丙烯酸酯、聚乙二醇二（甲基）丙烯酸酯、（甲基）丙烯酸酯改性明胶、(甲基)丙烯酸酯改性透明质酸。
  11. 一种用于植入青光眼患者眼内的房水引流器的制备方法，其特征在于：采用微流控方式制造。
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