CN115177433B - Degradable zinc alloy glaucoma drainage stent - Google Patents
Degradable zinc alloy glaucoma drainage stent Download PDFInfo
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- CN115177433B CN115177433B CN202211106706.7A CN202211106706A CN115177433B CN 115177433 B CN115177433 B CN 115177433B CN 202211106706 A CN202211106706 A CN 202211106706A CN 115177433 B CN115177433 B CN 115177433B
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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
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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
- A61F9/00736—Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments
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Abstract
The invention relates to a degradable zinc alloy glaucoma drainage stent, which belongs to the technical field of medical instruments and comprises a glaucoma drainage stent head end, a fixing groove and a glaucoma drainage stent tail end, wherein a section of anticoagulant drug coating and antimetabolite drug coating are loaded on the surface of the degradable zinc alloy glaucoma drainage stent. The drainage stent is made of degradable zinc alloy materials, so that the risks of blockage and hemolysis in glaucoma drainage device implantation are reduced. The head end and the tail end of the glaucoma drainage stent are fixed into a Venturi tube-shaped structure through the screw thread structure in a twisting mode, and the special Venturi tube-shaped structure can provide a good fixing effect for the glaucoma drainage stent. The anticoagulant drug coating can prevent hemolysis in eyes and reduce the risk of the intracameral hemorrhage, the antimetabolite drug coating can prevent the scar of the filtering channel tissue from protruding, and the drug coating solves the problems of hemolysis after operations and the scar formation of the filtering channel.
Description
Technical Field
The invention relates to a degradable zinc alloy glaucoma drainage stent, and belongs to the technical field of medical instruments.
Background
Glaucoma is a progressive and irreversible ocular disease, the initial symptoms of which are visual field loss, visual deterioration, headache or pain around the eyes, and severe cases of which can lead to blindness. At present, the condition of glaucoma is mainly controlled by drug therapy and surgical treatment, and drainage implant is an effective method for glaucoma surgical treatment.
The existing glaucoma minimally invasive drainage implants mainly comprise 4 types: (1) The EX-press glaucoma drainage device consists of a drainage tube cavity, a fixing thorn and a flat angle flange, and the structure ensures that the EX-press glaucoma drainage device has a good fixing function, but the drainage tube cavity is easy to block and generally needs acupuncture treatment; (2) Cy-pass is a polyimide tube with a plurality of drainage holes, 3 fixing rings are arranged at the near end, and postoperative complications are similar to EX-press glaucoma drainage devices and are easy to block; (3) The XEN type glaucoma drainage tube is formed by cross-linking pigskin gelatin and glutaraldehyde, and after the XEN type glaucoma drainage tube is placed, the drainage tube absorbs water and becomes soft, the curvature conforms to the radian of an eyeball, the foreign body sensation is low, but the XEN straight tube type structure has poor fixing effect and is easy to displace; (4) The iStent glaucoma drainage stent is a non-magnetic titanium stent with a heparin coating, directly communicates the anterior chamber with schlemm's canal to reduce intraocular pressure, and compared with the traditional glaucoma drainage mode, has no filter bulb related complications, but the problem of lumen blockage is still not solved.
The problems of lumen blockage, postoperative hemolysis, filter channel scarring and the like existing after the existing minimally invasive glaucoma drainage device often cause eye tissue damage, aqueous humor drainage failure, intraocular pressure runaway and even operation failure, so that a minimally invasive degradable drainage device for treating refractory glaucoma is urgently needed, and the technical problems of lumen blockage, postoperative hemolysis and filter channel scarring of the drainage device in the glaucoma treatment process are solved.
Disclosure of Invention
In order to solve the problems mentioned in the background, the invention provides a degradable zinc alloy glaucoma drainage stent which has the advantages of being not easy to displace, being capable of preventing hemolysis in eyes and the like.
The specific technical scheme of the invention is as follows:
a degradable zinc alloy glaucoma drainage stent comprises a glaucoma drainage stent head end, a fixing groove and a glaucoma drainage stent tail end; the surface of the degradable zinc alloy glaucoma drainage stent is loaded with a section of anticoagulant drug coating and antimetabolite drug coating.
Furthermore, the degradable zinc alloy glaucoma drainage stent is made of medical degradable zinc alloy.
Furthermore, the head end of the glaucoma drainage stent and the tail end of the glaucoma drainage stent are fixedly connected through a thread structure. The diameter of the thread is 1.4-1.6 mm, and the thread pitch is 1.0-1.5 mm.
Furthermore, the head end of the glaucoma drainage stent is integrally formed by an aqueous humor inflow conical tube and an internal thread tube, and the tail end of the glaucoma drainage stent is integrally formed by an external thread tube and an aqueous humor outflow conical tube;
furthermore, the surface of the head end of the glaucoma drainage stent is loaded with a layer of anticoagulant drug coating, and the surface of the tail end of the glaucoma drainage stent is loaded with a layer of antimetabolite drug coating;
furthermore, the head end of the glaucoma drainage stent is positioned at the head end of the degradable zinc alloy glaucoma drainage stent, the tail end of the glaucoma drainage stent is positioned at the tail end of the degradable zinc alloy glaucoma drainage stent, and the fixing groove is positioned between the head end of the glaucoma drainage stent and the tail end of the glaucoma drainage stent.
Furthermore, the degradable zinc alloy glaucoma drainage stent has a Venturi tube-shaped structure, the length of the stent is 6.0-8.0 mm, and the wall thickness is 0.2-0.4 mm.
Furthermore, the aqueous humor at the head end of the glaucoma drainage stent flows into the tube cavity of the conical tube, the outer diameter of the tube cavity is 2.0-3.0 mm, the inner diameter of the tube cavity is 1.8-2.6 mm, and the wall thickness of the tube cavity is 0.2-0.4 mm.
Furthermore, the outer diameter of the tube cavity of the fixing groove is 1.6-2 mm, the inner diameter of the tube cavity is 1.4-1.6 mm, and the wall thickness of the tube cavity is 0.2-0.4 mm.
Furthermore, the outer diameter of the lumen of the aqueous humor outflow conical tube at the tail end of the glaucoma drainage stent is 2.0-3.0 mm, the inner diameter of the lumen is 1.8-2.6 mm, and the wall thickness of the lumen is 0.2-0.4 mm.
Further, the drug coating process is a sectional drug loading method. The sectional type drug loading process comprises the following preparation method: preparing an anticoagulant drug coating on the head end of the glaucoma drainage stent by adopting a dipping method or a spraying method, preparing an antimetabolite drug coating on the tail end of the glaucoma drainage stent by adopting the dipping method or the spraying method, and screwing and fixing the head end of the glaucoma drainage stent and the tail end of the glaucoma drainage stent in an ultra-precision machining workbench.
Further, the anticoagulant drug comprises heparin, warfarin, new anticoagulant, aspirin and the like, and the coating concentration is 0.5-1.8 mgcm 2 。
Further, the antimetabolite species include mitomycin C, 5-fluorouracil, pirfenidone, lovastatin, rapamycin, rosiglitazone, amsacrine, and the like, and the coating concentration is 1.0-2.0 mg/cm 2 。
Compared with the prior art, the invention has the following outstanding beneficial effects:
the degradable zinc alloy glaucoma drainage stent is made of the degradable zinc alloy material, and after a filtering channel is stably formed, the glaucoma drainage stent is degraded and disappears in eyes, so that the risk of displacement of the glaucoma drainage stent is reduced, and a permanent drainage function can be provided; a Venturi tube-shaped structure is adopted to adjust the flow velocity of aqueous humor in a tube cavity and prevent the tube cavity from being blocked; the special groove structure of the Venturi tube can provide a good fixing effect for the glaucoma drainage tube, and the drainage tube is prevented from being excessively penetrated or extruded during puncture; the surface of the degradable zinc alloy glaucoma drainage stent is loaded with an anticoagulant drug coating and an antimetabolite drug coating by a sectional drug loading method, so that intraocular hemolysis is prevented, the risk of anterior chamber bleeding is reduced, the proliferation and migration of filtering channel tissues are inhibited, directional fibrosis is formed, and the stable drainage function of a filtering channel is realized.
Drawings
Fig. 1 is a schematic structural diagram of a degradable zinc alloy glaucoma drainage stent, and the reference numbers are listed as follows: 1. the glaucoma drainage stent comprises a glaucoma drainage stent head end 2, a fixing groove 3 and a glaucoma drainage stent tail end;
fig. 2 is a schematic structural diagram of a head end of a degradable zinc alloy glaucoma drainage stent, a is an overall structural diagram of the head end of the degradable zinc alloy glaucoma drainage stent, b is a top view of a thread structure of the head end of the degradable zinc alloy glaucoma drainage stent, and the reference numerals are listed as follows: 4. aqueous humor flows into the conical pipe 5 and the internal threaded pipe;
fig. 3 is a schematic diagram of the end structure of a degradable zinc alloy glaucoma drainage stent, a is a top view of the end thread structure of the degradable zinc alloy glaucoma drainage stent, b is an overall structure diagram of the end of the degradable zinc alloy glaucoma drainage stent, and the reference numerals are listed as follows: 6. an external thread pipe 7, a water outflow conical pipe;
FIG. 4 is a schematic view of a tubular structure of a degradable zinc alloy glaucoma drainage stent;
fig. 5 is a schematic diagram of the in vitro degradation mass loss rate of a degradable zinc alloy glaucoma drainage stent, with the list of reference numbers: a. comparative example 1, b example 2;
fig. 6 is a schematic diagram of the in vitro release cumulative release of rapamycin for a degradable zinc alloy glaucoma drainage stent, the list of reference numbers: a. comparative example 5, b comparative example 6, c example 2, d example 5, e example 6;
fig. 7 is a schematic diagram of the in vitro release cumulative release degree of heparin sodium of a degradable zinc alloy glaucoma drainage stent, and the reference numbers are listed as follows: a. comparative example 7, b comparative example 8, c example 2, d example 7, e example 8;
fig. 8 is a schematic diagram of the survival rate of a functional filtering bleb of a degradable zinc alloy glaucoma drainage stent, the list of reference numbers being: a. comparative example 1, b comparative example 2, c comparative example 3, d comparative example 4, e example 2, f example 3, g example 4;
FIG. 9 is a graph of the rapamycin standard curve of Table 1;
figure 10 is the heparin standard graph of table 2.
Detailed Description
The technical solution of the present invention is further described in detail with reference to the accompanying drawings and specific embodiments.
Example 1
Referring to fig. 1-3, a degradable zinc alloy glaucoma drainage stent, includes glaucoma drainage stent head end (1), a fixed recess (2) and a glaucoma drainage stent end (3), glaucoma drainage stent head end (1) and glaucoma drainage stent end (3) are through helicitic texture fixed connection, glaucoma drainage stent head end (1) flows into conical duct (4) and internal thread pipe (5) integrated into one piece by the aqueous humor, glaucoma drainage stent end (3) is flowed out conical duct (7) integrated into one piece by external thread pipe (6) and aqueous humor, fixed recess is located between glaucoma drainage stent head end and the glaucoma drainage stent end. The degradable zinc alloy glaucoma drainage stent adopts medical grade degradable zinc alloy, shortens the retention time of the drainage implantation stent in eye tissues, and reduces the risk of displacement of the glaucoma drainage stent. The degradable zinc alloy glaucoma drainage stent adopts a special Venturi tube-shaped structure, so that the stability of the glaucoma drainage stent is improved, the flow rate of aqueous humor in a tube cavity can be adjusted, and the tube cavity is prevented from being blocked.
The surface of the degradable zinc alloy glaucoma drainage stent is loaded with two drug coatings of anticoagulation and anti-metabolism, so that the risk of intraocular hemolysis is reduced, and the drainage function of a filter channel is maintained. The drug coating is loaded by adopting a sectional drug loading process, taking heparin sodium and rapamycin as examples, the method comprises the following steps:
(1) Preparation of a spraying solution: weighing a certain amount of PLGA (75) and heparin sodium (the mass ratio of PLGA (75); weighing a certain amount of PLGA (75) and rapamycin (the mass ratio of PLGA (75) to rapamycin is 1);
(2) Respectively cleaning the head end and the tail end of the degradable zinc alloy glaucoma drainage stent by absolute ethyl alcohol to remove impurities, drying and then placing in a spraying equipment operating table;
(3) The spraying solution is pre-loaded in spraying equipment, the operating table is operated at a speed of 10-20 mm/s, the feeding speed is 1.2 rev/s, the drying time is 3-5 s, and the weight is weighed once every spraying until the target drug-loading rate is loaded for later use;
(4) The head end and the tail end of the degradable zinc alloy glaucoma drainage stent are arranged on an ultraprecise machining workbench to be screwed and assembled.
Example 2
The structure of the degradable zinc alloy glaucoma drainage stent is shown in the embodiment 1, and the length specification of the stent can be 7.0 mm; the aqueous humor flows into the specification of the conical pipe, the outer diameter of the pipe cavity can be selected to be 2.5 mm, the inner diameter of the pipe cavity is 2.2 mm, and the pipe cavityThe wall thickness is 0.3 mm; the specification of the fixing groove can adopt the specification that the outer diameter of a tube cavity is 1.8 mm, the inner diameter of the tube cavity is 1.5 mm, and the wall thickness of the tube cavity is 0.3 mm; the specification of the aqueous humor outflow conical tube can be 2.5 mm in outer diameter of a tube cavity, 2.2 mm in inner diameter of the tube cavity and 0.3 mm in wall thickness of the tube cavity; the thread specification can be 1.5 mm in diameter and 1.25 mm in thread pitch; the concentration of the anticoagulant drug coating can be 1.2 mg/cm 2 The concentration of the antimetabolite coating can be selected to be 1.5 mg/cm 2 。
Example 3
The structure of the degradable zinc alloy glaucoma drainage stent is shown in the embodiment 1, and the length specification of the stent can be 6.0 mm; the specification of the aqueous humor inflow conical tube can be 2.0 mm in outer diameter of a tube cavity, 1.8 mm in inner diameter of the tube cavity and 0.2 mm in wall thickness of the tube cavity; the specification of the fixed groove can adopt the specification that the outer diameter of a tube cavity is 1.6 mm, the inner diameter of the tube cavity is 1.4 mm, and the wall thickness of the tube cavity is 0.2 mm; the specification of the aqueous humor outflow conical tube can be 2.0 mm in outer diameter of a tube cavity, 1.8 mm in inner diameter of the tube cavity and 0.2 mm in wall thickness of the tube cavity; the thread specification can be 1.4 mm in diameter and 1.0 mm in thread pitch; the concentration of the anticoagulant drug coating can be 0.5 mg/cm 2 The concentration of the coating of the antimetabolite drug can be selected to be 1.0 mg/cm 2 。
Example 4
The structure of the degradable zinc alloy glaucoma drainage stent is shown in the embodiment 1, and the length specification of the stent can be 8.0 mm; the specification of the aqueous humor inflow conical tube can be that the outer diameter of a tube cavity is 3.0 mm, the inner diameter of the tube cavity is 2.6 mm, and the wall thickness of the tube cavity is 0.4 mm; the specification of the fixed groove can adopt the specification that the outer diameter of a tube cavity is 2.0 mm, the inner diameter of the tube cavity is 1.6 mm, and the wall thickness of the tube cavity is 0.4 mm; the specification of the aqueous humor outflow conical tube can be 3.0 mm of the outer diameter of a tube cavity, 2.6 mm of the inner diameter of the tube cavity and 0.4 mm of the wall thickness of the tube cavity; the thread specification can be 1.6 mm in diameter and 1.5 mm in thread pitch; the concentration of the anticoagulant drug coating can be 1.8 mg/cm 2 The concentration of the antimetabolite coating can be selected to be 2.0 mg/cm 2 。
Example 5
Degradable zinc alloy glaucomaThe drainage stent structure is shown in the embodiment 1, and the length specification of the stent can be 7.0 mm; the specification of the aqueous humor inflow conical tube can be 2.5 mm in outer diameter of a tube cavity, 2.2 mm in inner diameter of the tube cavity and 0.3 mm in wall thickness of the tube cavity; the specification of the fixed groove can adopt the specification that the outer diameter of a tube cavity is 1.8 mm, the inner diameter of the tube cavity is 1.5 mm, and the wall thickness of the tube cavity is 0.3 mm; the specification of the aqueous humor outflow conical tube can be 2.5 mm in outer diameter of a tube cavity, 2.2 mm in inner diameter of the tube cavity and 0.3 mm in wall thickness of the tube cavity; the thread specification can be 1.5 mm in diameter and 1.25 mm in thread pitch; the concentration of the anticoagulant drug coating can be 1.2 mg/cm 2 The concentration of the coating of the antimetabolite drug can be 1 mg/cm 2 。
Example 6
The structure of the degradable zinc alloy glaucoma drainage stent is shown in the embodiment 1, and the length specification of the stent can be 7.0 mm; the specification of the aqueous humor inflow conical tube can be 2.5 mm in outer diameter of a tube cavity, 2.2 mm in inner diameter of the tube cavity and 0.3 mm in wall thickness of the tube cavity; the specification of the fixed groove can adopt the specification that the outer diameter of a tube cavity is 1.8 mm, the inner diameter of the tube cavity is 1.5 mm, and the wall thickness of the tube cavity is 0.3 mm; the specification of the aqueous humor outflow conical tube can be 2.5 mm in outer diameter of a tube cavity, 2.2 mm in inner diameter of the tube cavity and 0.3 mm in wall thickness of the tube cavity; the thread specification can be 1.5 mm in diameter and 1.25 mm in thread pitch; the concentration of the anticoagulant drug coating can be 1.2 mg/cm 2 The concentration of the antimetabolite coating can be selected to be 2 mg/cm 2 。
Example 7
The structure of the degradable zinc alloy glaucoma drainage stent is shown in the embodiment 1, and the length specification of the stent can be 7.0 mm; the specification of the aqueous humor inflow conical tube can be 2.5 mm in outer diameter of a tube cavity, 2.2 mm in inner diameter of the tube cavity and 0.3 mm in wall thickness of the tube cavity; the specification of the fixed groove can adopt the specification that the outer diameter of a tube cavity is 1.8 mm, the inner diameter of the tube cavity is 1.5 mm, and the wall thickness of the tube cavity is 0.3 mm; the specification of the aqueous humor outflow conical tube can be 2.5 mm in outer diameter of a tube cavity, 2.2 mm in inner diameter of the tube cavity and 0.3 mm in wall thickness of the tube cavity; the thread specification can be 1.5 mm in diameter and 1.25 mm in thread pitch; the concentration of the anticoagulant drug coating can be 0.5 mg/cm 2 The concentration of the coating of the antimetabolite drug can be 1.5 mg/cm 2 。
Example 8
The degradable zinc alloy glaucoma drainage stent structure is shown in embodiment 1, and the length specification of the stent can be 7.0 mm; the specification of the aqueous humor inflow conical tube can be 2.5 mm in outer diameter of a tube cavity, 2.2 mm in inner diameter of the tube cavity and 0.3 mm in wall thickness of the tube cavity; the specification of the fixed groove can adopt the specification that the outer diameter of a tube cavity is 1.8 mm, the inner diameter of the tube cavity is 1.5 mm, and the wall thickness of the tube cavity is 0.3 mm; the specification of the aqueous humor outflow conical tube can be 2.5 mm in outer diameter of a tube cavity, 2.2 mm in inner diameter of the tube cavity and 0.3 mm in wall thickness of the tube cavity; the thread specification can be 1.5 mm in diameter and 1.25 mm in thread pitch; the concentration of the anticoagulant drug coating can be 1.8 mg/cm 2 The concentration of the antimetabolite coating can be selected to be 1.5 mg/cm 2 。
Comparative example 1
The structure of the non-degradable stainless steel glaucoma drainage stent is the same as that of the degradable zinc alloy glaucoma drainage stent, as shown in figure 1, the length specification of the stent can be 7.0 mm; the specification of the aqueous humor inflow conical tube can be 2.5 mm in outer diameter of a tube cavity, 2.2 mm in inner diameter of the tube cavity and 0.3 mm in wall thickness of the tube cavity; the specification of the fixing groove can adopt the specification that the outer diameter of a tube cavity is 1.8 mm, the inner diameter of the tube cavity is 1.5 mm, and the wall thickness of the tube cavity is 0.3 mm; the specification of the aqueous humor outflow conical tube can be 2.5 mm in outer diameter of a tube cavity, 2.2 mm in inner diameter of the tube cavity and 0.3 mm in wall thickness of the tube cavity; the thread specification can be 1.5 mm in diameter and 1.25 mm in thread pitch; the concentration of the anticoagulant drug coating can be 1.2 mg/cm 2 The concentration of the antimetabolite coating can be selected to be 1.5 mg/cm 2 。
Comparative example 2
The degradable zinc alloy glaucoma drainage stent structure is shown in embodiment 1, and the length specification of the stent can be 9.0 mm; the specification of the aqueous humor inflow conical tube can be that the outer diameter of a tube cavity is 4.0 mm, the inner diameter of the tube cavity is 3.5 mm, and the wall thickness of the tube cavity is 0.5 mm; the specification of the fixed groove can adopt the specification that the outer diameter of a tube cavity is 3.0 mm, the inner diameter of the tube cavity is 2.5 mm, and the wall thickness of the tube cavity is 0.5 mm; the aqueous humor flows out the taper pipe gaugeThe outer diameter of the tube cavity can be 4.0 mm, the inner diameter of the tube cavity is 3.5 mm, and the wall thickness of the tube cavity is 0.5 mm; the thread specification can be 2.5 mm in diameter and 2.0 mm in thread pitch; the concentration of the anticoagulant drug coating can be 2.0 mg/cm 2 The concentration of the antimetabolite coating can be selected to be 2.5 mg/cm 2 。
Comparative example 3
The structure of the degradable zinc alloy glaucoma drainage stent is shown in the embodiment 1, and the length specification of the stent can be 5.0 mm; the specification of the aqueous humor inflow conical tube can be 1.5 mm in outer diameter of a tube cavity, 1.4 mm in inner diameter of the tube cavity and 0.1 mm in wall thickness of the tube cavity; the specification of the fixed groove can adopt the specification that the outer diameter of a tube cavity is 1.2 mm, the inner diameter of the tube cavity is 1.1 mm, and the wall thickness of the tube cavity is 0.1 mm; the specification of the aqueous humor outflow conical tube can be 1.5 mm in outer diameter of a tube cavity, 1.4 mm in inner diameter of the tube cavity and 0.1 mm in wall thickness of the tube cavity; the thread specification can be 1.3 mm in diameter and 0.4 mm in thread pitch; the concentration of the anticoagulant drug coating can be 0.3 mg/cm 2 The concentration of the antimetabolite coating can be selected to be 0.8 mg/cm 2 。
Comparative example 4
The structure of the degradable zinc alloy glaucoma drainage stent is shown in figure 4, the length specification of the stent can be 7.0 mm, the outer diameter of a tube cavity is 2.5 mm, the inner diameter of the tube cavity is 2.2 mm, and the wall thickness of the tube cavity is 0.3 mm; the concentration of the anticoagulant drug coating can be 1.2 mg/cm 2 The concentration of the antimetabolite coating can be selected to be 1.5 mg/cm 2 。
Comparative example 5
The degradable zinc alloy glaucoma drainage stent structure is shown in embodiment 1, and the length specification of the stent can be 7.0 mm; the specification of the aqueous humor inflow conical tube can be that the outer diameter of a tube cavity is 2.5 mm, the inner diameter of the tube cavity is 2.2 mm, and the wall thickness of the tube cavity is 0.3 mm; the specification of the fixing groove can adopt the specification that the outer diameter of a tube cavity is 1.8 mm, the inner diameter of the tube cavity is 1.5 mm, and the wall thickness of the tube cavity is 0.3 mm; the specification of the aqueous humor outflow conical tube can be 2.5 mm in outer diameter of a tube cavity, 2.2 mm in inner diameter of the tube cavity and 0.3 mm in wall thickness of the tube cavity; the thread specification can be 1.5 mm in diameter and 1.25 mm in thread pitch; the anticoagulationThe concentration of the drug coating can be 1.2 mg/cm 2 The concentration of the coating of the antimetabolite drug can be 2.5 mg/cm 2 。
Comparative example 6
The structure of the degradable zinc alloy glaucoma drainage stent is shown in the embodiment 1, and the length specification of the stent can be 7.0 mm; the specification of the aqueous humor inflow conical tube can be that the outer diameter of a tube cavity is 2.5 mm, the inner diameter of the tube cavity is 2.2 mm, and the wall thickness of the tube cavity is 0.3 mm; the specification of the fixing groove can adopt the specification that the outer diameter of a tube cavity is 1.8 mm, the inner diameter of the tube cavity is 1.5 mm, and the wall thickness of the tube cavity is 0.3 mm; the specification of the aqueous humor outflow conical tube can be 2.5 mm in outer diameter of a tube cavity, 2.2 mm in inner diameter of the tube cavity and 0.3 mm in wall thickness of the tube cavity; the thread specification can be 1.5 mm in diameter and 1.25 mm in thread pitch; the concentration of the anticoagulant drug coating can be 1.2 mg/cm 2 The concentration of the antimetabolite coating can be selected to be 0.8 mg/cm 2 。
Comparative example 7
The structure of the degradable zinc alloy glaucoma drainage stent is shown in the embodiment 1, and the length specification of the stent can be 7.0 mm; the specification of the aqueous humor inflow conical tube can be that the outer diameter of a tube cavity is 2.5 mm, the inner diameter of the tube cavity is 2.2 mm, and the wall thickness of the tube cavity is 0.3 mm; the specification of the fixed groove can adopt the specification that the outer diameter of a tube cavity is 1.8 mm, the inner diameter of the tube cavity is 1.5 mm, and the wall thickness of the tube cavity is 0.3 mm; the specification of the aqueous humor outflow conical tube can be 2.5 mm in outer diameter of a tube cavity, 2.2 mm in inner diameter of the tube cavity and 0.3 mm in wall thickness of the tube cavity; the thread specification can be 1.5 mm in diameter and 1.25 mm in thread pitch; the concentration of the anticoagulant drug coating can be 2.0 mg/cm 2 The concentration of the coating of the antimetabolite drug can be 1.5 mg/cm 2 。
Comparative example 8
The structure of the degradable zinc alloy glaucoma drainage stent is shown in the embodiment 1, and the length specification of the stent can be 7.0 mm; the specification of the aqueous humor inflow conical tube can be that the outer diameter of a tube cavity is 2.5 mm, the inner diameter of the tube cavity is 2.2 mm, and the wall thickness of the tube cavity is 0.3 mm; the specification of the fixed groove can adopt the specification that the outer diameter of a tube cavity is 1.8 mm, the inner diameter of the tube cavity is 1.5 mm, and the wall thickness of the tube cavity is 0.3 mm; the aqueous humor flows outThe specification of the conical tube can select the outer diameter of a tube cavity of 2.5 mm, the inner diameter of the tube cavity of 2.2 mm and the wall thickness of the tube cavity of 0.3 mm; the thread specification can be 1.5 mm in diameter and 1.25 mm in thread pitch; the concentration of the anticoagulant drug coating can be 0.3 mg/cm 2 The concentration of the antimetabolite coating can be selected to be 1.5 mg/cm 2 。
Verification example
In vitro degradation protocol: weighing the degradable zinc alloy glaucoma drainage stent, placing the degradable zinc alloy glaucoma drainage stent into a 10 mL centrifuge tube, adding 10 mL Hank's simulated body fluid, taking out 1 group of samples every 1 month, washing, drying and weighing. The weight before degradation is recorded as m A And the weight after degradation is recorded as m B The mass loss rate is recorded as M, and the mass loss after degradation is calculated as follows:
M=(m A -m B )/ m A *100%
in vitro sustained release protocol: (1) drawing a heparin and rapamycin standard curve; (2) in vitro sustained release medium: body fluids were simulated according to Hank's: preparing an in vitro slow release medium according to the proportion of propylene glycol = 19; (3) The degradable zinc alloy glaucoma drainage stent is placed in a 500 mL conical flask, 500 mL of in vitro slow release medium is added, 2.5 mL of release medium is taken at regular intervals, 2.5 mL of in vitro slow release medium is added at the same time, an ultraviolet spectrophotometer is adopted for testing, parallel measurement is carried out for 3 times, an average value is taken, and measurement is carried out for 1 time at intervals of 24 h.
Animal experimental protocol: 70 adult New Zealand white rabbits, weighing 2.5-3.0 kg, were female, and were implanted with 1 glaucoma drainage device per rabbit, according to the experimental requirements. Before the operation, an operator uses normal saline to wash the glaucoma drainage device smoothly for later use. A conventional ophthalmic sterile drape was infiltrated with 2% lidocaine 3.0 mL ball for anesthesia. On the side of the superotemporal quadrant or the superonasal quadrant, 3-4 mm away from the corneal limbus, a needle head penetrates into the anterior chamber to be used as a preset incision, a scleral flap is manufactured, and the anterior chamber is filled with viscoelastic agent; implanting a glaucoma drainage device pre-mounted on the hand-held positioner through the pre-set incision, checking the implantation position, and suturing the scleral flap and the conjunctival flap. The eyes were observed under a slit lamp microscope at 1, 2, 3, 6, 9, 12 months after surgery, and the number of functional blebs surviving was recorded and the survival rate was calculated.
The specific in vitro degradation experimental result is shown in fig. 5, the degradable zinc alloy glaucoma drainage stent starts to degrade in month 3, the degradation rate is gradually accelerated, the non-degradable stainless steel glaucoma drainage stent only digests the drug coating, and the degradable zinc alloy glaucoma drainage stent has good degradation performance.
Results of specific in vitro release experiments, rapamycin Standard Curve is shown in Table 1 and FIG. 9, R 2 =0.9999, the correlation of a standard curve is remarkable, as shown in fig. 6, the drug coating of the degradable zinc alloy glaucoma drainage stent has a drug slow release effect, the drug release degree is more than 85%, the drug concentration of comparative example 5 is high, the release degree is low, the accumulated release dosage is too high according to the mass loss amount of the stent, the drug concentration of comparative example 6 is low, and the drug release time is short; example 5 the drug concentration is lower, the release rate is more stable, and the drug release time is shorter; example 6 higher drug concentration, longer drug release time; the release rate of the embodiment 2 is stable, and the release performance is good; the heparin standard curve is shown in Table 2 and FIG. 10, R 2 =0.9999, the correlation of a standard curve is remarkable, as shown in fig. 7, the drug coating of the degradable zinc alloy glaucoma drainage stent has a drug slow release effect, the drug release degree is above 87%, the drug concentration of comparative example 7 is high, the release degree is low, the accumulated release dosage is too high according to the mass loss amount of the stent, the drug concentration of comparative example 8 is low, and the drug release time is short; example 7 the drug concentration is lower, the release rate is more stable, and the drug release time is shorter; example 8 the drug concentration is higher and the drug release time is longer; the release rate of example 2 is relatively stable and the release performance is good.
Specific animal experiment results are shown in table 3, table 4 and fig. 8, the non-degradable stainless steel glaucoma drainage stent of comparative example 1 has higher survival rate of the functional filtering bubbles, and has higher migration extrusion rate compared with the degradable zinc alloy glaucoma drainage stent; comparative example 2 the drug-loading rate of the drug coating of the degradable zinc alloy glaucoma drainage stent is lower than the effective drug effect amount, and the survival rate of the functional filtering bleb is lower; comparative example 3 the drug-loading rate of the drug coating of the degradable zinc alloy glaucoma drainage stent is higher than the effective drug action amount, the survival rate of the functional filtering bleb is low, and complications such as spontaneous hemorrhage of eye tissues and lumen blockage can be caused; comparative example 4 the degradable zinc alloy glaucoma drainage stent has poor structural fixing performance and high migration and extrusion rate, so that the survival rate of the functional filtering bleb is low; examples 2-4 the degradable zinc alloy glaucoma drainage stent has low migration and extrusion rate, high survival rate of functional filtering bubbles and excellent drainage and filtration performance.
TABLE 1 rapamycin Standard Curve
TABLE 2 heparin standard curve
TABLE 3 cumulative functional filtration blister number after operation (number of eyes observed 10)
TABLE 4 cumulative post-operative migration extrusion eye count (number of observation eyes 10)
Claims (4)
1. A degradable zinc alloy glaucoma drainage stent is characterized by comprising a glaucoma drainage stent head end (1), a fixing groove (2) and a glaucoma drainage stent tail end (3); the degradable zinc alloy glaucoma drainage stent has a Venturi tube-shaped structure, and the length of the stent is 6.0-8.0 mm; the head end (1) of the glaucoma drainage stent is fixedly connected with the tail end (3) of the glaucoma drainage stent through a thread structure; the diameter of the thread is 1.4-1.6 mm, and the thread pitch is 1.0-1.5 mm; the head end (1) of the glaucoma drainage stent flows into the conical pipe (4) and the internal thread from aqueous humorThe pipe (5) is integrally formed; the outer diameter of an inlet tube cavity at the head end of the aqueous humor inflow conical tube (4) is 2.0-3.0 mm, the inner diameter of the inlet tube cavity is 1.8-2.6 mm, and the wall thickness of the tube cavity is 0.2-0.4 mm; the fixing groove (2) is positioned between the head end (1) of the glaucoma drainage stent and the tail end (3) of the glaucoma drainage stent, the outer diameter of the tube cavity is 1.6-2.0 mm, the inner diameter of the tube cavity is 1.4-1.6 mm, and the wall thickness of the tube cavity is 0.2-0.4 mm; the tail end (3) of the glaucoma drainage stent is integrally formed by an external thread tube (6) and an aqueous humor outflow conical tube (7); the outer diameter of an outlet tube cavity at the tail end of the aqueous humor outflow conical tube (7) is 2.0-3.0 mm, the inner diameter of the outlet tube cavity is 1.8-2.6 mm, and the wall thickness of the tube cavity is 0.2-0.4 mm; the degradable zinc alloy glaucoma drainage stent is made of medical-grade degradable zinc alloy; the surface of the degradable zinc alloy glaucoma drainage stent is loaded with a section of anticoagulant drug coating and an antimetabolite drug coating, and the concentration of the anticoagulant drug coating is 0.5-1.8 mg/cm 2 The coating concentration of the antimetabolite is 1.0-2.0 mg/cm 2 。
2. The degradable zinc alloy glaucoma drainage stent of claim 1 which is surface-loaded with an anticoagulant drug coating and an antimetabolite drug coating by a step-loading method, wherein the surface of the head end (1) of the glaucoma drainage stent is surface-loaded with an anticoagulant drug coating, and the surface of the tail end (3) of the glaucoma drainage stent is surface-loaded with an antimetabolite drug coating.
3. The degradable zinc alloy glaucoma drainage stent of claim 1 wherein the anticoagulant drug coating is one or more of heparin, warfarin, neo-anticoagulant and aspirin.
4. The degradable zinc alloy glaucoma drainage stent of claim 1 wherein the antimetabolite coating is one or more of mitomycin C, 5-fluorouracil, pirfenidone, lovastatin, rapamycin, rosiglitazone and amsacrine.
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