CN113367885B

CN113367885B - Glaucoma drainage tube, material thereof and implantation device

Info

Publication number: CN113367885B
Application number: CN202010163648.6A
Authority: CN
Inventors: 周永华; 李翔骥; 李继伟
Original assignee: Third Affiliated Hospital Of Cqmu (gener Hospital); Chengdu Migos Medical Technology Co ltd
Current assignee: Chengdu Migos Medical Technology Co ltd
Priority date: 2020-03-10
Filing date: 2020-03-10
Publication date: 2022-07-29
Anticipated expiration: 2040-03-10
Also published as: CN113367885A

Abstract

The invention discloses a glaucoma drainage tube, a material thereof and an implantation device, which comprise a tube body made of a thermal cross-linking elastic material, wherein the tube body comprises an outer tube and an inner tube, the proximal end of the tube body is provided with an expansion section, and the inner tube at the distal end of the tube body extends from the inside of the tube body to the outside. The thermal crosslinking elastic material is prepared by copolymerizing three types of monomers by adopting anionic polymerization, and then converting unsaturated double bonds of conjugated diene monomer units into saturated carbon-carbon bonds by selective catalytic hydrogenation treatment; the thermally crosslinkable elastic material can form chemical crosslinking through heating to be converted into a thermosetting elastic material, and is manufactured into a tube body of the glaucoma drainage tube. The body outer wall is equipped with the pit, and a plurality of pits are the array and distribute. The invention can effectively reduce the scarring of the filtering bulb, prevent the aging and the deformation of the drainage tube, keep the good fixation of the tube body, avoid the position change in the eyes, control the intraocular pressure, effectively avoid the problems of low intraocular pressure and shallow anterior chamber and prevent the blockage.

Description

Glaucoma drainage tube, material thereof and implantation device

Technical Field

The invention relates to the field of medical instruments, in particular to a glaucoma drainage tube, a material thereof and an implantation device.

Background

Glaucoma is a characteristic optic nerve disease mainly including visual field defect and optic nerve atrophy, and elevated intraocular pressure (IOP) is a major risk factor for optic nerve atrophy of glaucoma. Glaucoma is the second leading cause of blindness worldwide, second only to cataract, and the first irreversible blindness-causing eye disease. By 2020, the prevalence rate of people over 40 years old reaches 2182 ten thousand (accounting for 27.4 percent of the world) of people with ultramarine glaucoma in China. As the population ages, the number of glaucoma patients will rise dramatically.

The current treatment of glaucoma includes three major categories, drug therapy, laser therapy and surgical therapy, the classic surgical treatment is trabeculectomy, which requires making conjunctival and scleral flaps and cutting off a portion of trabecular meshwork to reestablish the passage of the aqueous outflow to lower intraocular pressure. But the postoperative intraocular pressure is increased again and the success rate of the operation is obviously reduced because the surgical wound surface is larger, the adhesion of the filtering channel and the scarring of the filtering bubble are common.

Glaucoma aqueous humor drainage implant devices are one direction of development to address the above-mentioned problems. The classic conventional implant is the Ahmed valve (us patent: 5971408, MEDICAL VAVLES), but the post-operative scarring is still severe due to the use of conventional silicone materials and the oversized surgical incision (requiring the opening of a large area of conjunctiva to implant the drainage valve disc). In addition, due to the manufacturing process problem of the internal pressure control valve, the drainage control of the valve aqueous humor is often not ideal, and the hypotony and the superficial anterior chamber are common problems after the operation.

The Epson ExPRESS drainage nail is a drainage device for subconjunctival route already on the market, but due to the use of stainless steel material and a similar surgical route to the classical trabeculectomy (which requires opening of the conjunctiva and making of the scleral flap, but the removal of the trabecular meshwork is replaced by an implant), the scarring problem is still more severe, and the success rate of the surgery is similar to that of the trabeculectomy, without significant improvement (Yvon M. buy. Trbeculectomy with ExPRESS: weighing the repair and cost. curr Ophthalmol 2013,24: 111-. The XeN drain valve from El corporation is the most recently approved subconjunctival drain valve from the US FDA, uses gelatin as a material and uses minimally invasive implantation to reduce the incidence of scarring, but the design does not take into account fixation of the implanted device and potential position shift issues with the device after implantation (Dervenis et al, location of a previous surgery XEN glaucomatous implant into the implant chamber: a case report. BMC Ophthalmology2017,17: 148). MicroShunt from Inn Focus employs SIBS material (Pinchuk L, Riss I, Batle JF, Kato YP, Martin JB, Arrieta E, Palmberg P, Parrish RK, Weber BA, Kwon Y, Parel J-M. the depth of a micro-shun male membrane from poly (styrene-block-isobutylene-block-styrene) turbine glaucoma. J Biomed Mater Res Part B2017: 105B:211-221), but also has the risk of scarring. Meanwhile, the SIBS material has potential problems of size deformation and aging because the SIBS material is not crosslinked.

Disclosure of Invention

The invention aims to provide a glaucoma drainage tube, a material and an implantation device thereof, which can effectively reduce the scarring of a filtering bubble through the biocompatibility of the material, a minimally invasive surgery path and a wound brought by the implantation device and the drug-loading characteristic of the material. And further effectively prevent aging and deformation through the cross-linking process of the material; the expansion section at the near end of the tube body, the two inner tubes led out of the outer tube body at the far end of the tube body and the pits distributed on the outer surface of the tube body keep the tube body well fixed, and the position change in the eyes is avoided; the intraocular pressure is controlled by the selection of the pipe diameter and the combination of two parallel inner pipes, so that the problems of low intraocular pressure and superficial anterior chamber are effectively avoided, and the blockage is prevented.

In order to achieve the purpose, the invention is realized by adopting the following technical scheme:

the invention provides a glaucoma drainage tube prepared by adopting a thermal-crosslinking elastic material, which can overcome the defects of the current glaucoma drainage tube.

The elastic material is synthesized by adopting active anion polymerization, and does not contain small molecular additives or residual components; the elastic material has no unstable double bonds in the molecular structure after selective catalytic hydrogenation, so that the elastic material has good high-temperature oxidation resistance and biological stability; the elastic material only contains two elements of carbon and hydrogen, so that the elastic material is nonpolar, does not absorb moisture and has no groups which can be hydrolyzed and degraded; the elastic material can be chemically cross-linked upon heating without the addition of any other substance such as a catalyst and without the release of any small molecule substance. The material can be used for various medical devices implanted in human bodies which bear stress for a long time or need to keep the shape permanently after being heated and crosslinked, including glaucoma drainage tubes.

The preparation method of the thermal-crosslinkable elastic material comprises the following steps:

1) adding a solvent cyclohexane subjected to dehydration and deoxidation treatment into a reaction vessel at 50-90 ℃ in an anhydrous and oxygen-free inert gas atmosphere, and removing impurities by using alkyl lithium;

2) quantitatively adding initiator alkyl lithium, sequentially adding monomers including thermal crosslinking monomers (vinyl aromatic hydrocarbon, isoprene and thermal crosslinking monomers) to complete polymerization reactions of all sections, and finally adding a chain terminator (generally alcohol) to finish the polymerization reaction;

3) selectively catalyzing and hydrogenating the polymerization product in a solution, and performing addition reaction on unsaturated double bonds in an isoprene monomer unit by using hydrogen and the unsaturated double bonds in the isoprene monomer unit at 50-90 ℃ and under the pressure of 1.6-3.0MPa by using a nickel-based, cobalt-based or titanium-based catalyst, wherein the molecular structures of vinyl aromatic hydrocarbon and a crosslinkable monomer unit are not influenced;

4) after selective catalytic hydrogenation, the polymer is subjected to a series of purification operations of removing the catalyst and the solvent, and then is dried in vacuum to constant weight, so that the elastic material capable of thermal crosslinking can be obtained. The obtained elastic material can generate crosslinking reaction at high temperature, so that the thermal crosslinking elastic material is converted into a thermosetting elastic material.

The invention discloses a glaucoma drainage tube, which comprises an outer tube and inner tubes, wherein the two inner tubes are fixedly arranged in the outer tube side by side, and the outer tube and the inner tubes are made of the above materials.

Preferably, the proximal end of the outer tube is provided with an expansion section,

in a natural state, the outer diameter of the expansion section is larger than that of the outer pipe,

in the contracted state, the outer diameter of the expanded end is equal to the outer diameter of the outer tube.

Preferably, the distal end of the inner tube extends outside the outer tube,

in a natural state, the distal end of the inner tube is arc-shaped, the axial distance between the tail part of the inner tube and the outer tube is gradually increased from the head to the tail,

under the contraction state, the distance between the edge of the far end of the inner tube far away from the axial direction of the outer tube and the axial direction of the outer tube is less than or equal to the outer diameter of the outer tube.

Preferably, the outer wall of the outer pipe is provided with pits, a plurality of pits are distributed in an array,

the outer wall of the outer tube is loaded with a drug therapeutic agent which is mitomycin C or 5-fluorouracil.

The invention also discloses an implantation device of the glaucoma drainage tube, which comprises the drainage tube, a shell, a puncture component and a pushing component;

the tail part of the shell is detachably connected with a tail cover, a window is arranged on the side wall of the shell, a rotating cylinder is coaxially arranged in the shell, a forward-rotating thread is arranged on the inner wall of the top of the rotating cylinder, a reverse-rotating thread is arranged on the inner wall of the bottom of the rotating cylinder, the rotating cylinder is in rotating fit with the inner wall of the shell, a first sliding groove is arranged on the inner wall of the top of the shell, a second sliding groove is arranged on the inner wall of the bottom of the shell, and the first sliding groove and the second sliding groove are both arranged along the axial direction of the shell;

The puncture assembly comprises a needle head, a connecting section and a base which are coaxially arranged from top to bottom in sequence, a first sliding convex edge is arranged on the outer wall of the base and matched with a first sliding chute, the top of a rotary cylinder is sleeved on the periphery of the bottom of the base, the rotary cylinder is in threaded connection with the base, and a drainage tube is arranged at the top of an inner cavity of the needle head;

the promotion subassembly includes the catch bar, and the catch bar top is equipped with the promotion needle, promotes needle top and inserts syringe needle bottom, promotes needle sliding connection syringe needle, and the base is run through at the catch bar top, and the catch bar middle part is equipped with the screw thread section, screw thread section periphery and rotatory bobbin base threaded connection, and the catch bar afterbody is equipped with the protruding stupefied of second slip, and the protruding stupefied adaptation second spout of second slip.

Preferably, the tail end of the push rod penetrates through the tail cover, the tail end of the push rod extends out of the tail cover, and the tail part of the push rod is provided with scale marks.

Preferably, the housing includes an upper portion and a lower portion, and the window is located at the bottom end of the upper portion.

Preferably, the inner wall of the bottom of the upper portion is provided with a stepped hole, the inner wall of the top of the lower portion is provided with a ring groove, the periphery of the top of the rotary drum is provided with a first annular convex rib, the periphery of the bottom of the rotary drum is provided with a second annular convex rib, the first annular convex rib is matched with the stepped hole, and the second annular convex rib is matched with the ring groove.

Preferably, the catch bar bottom is equipped with the sliding section, sliding section periphery and shell inner wall sliding fit, and the sliding section periphery is located to the protruding stupefied of second slip.

Preferably, the top end of the push needle is of a round blunt structure.

The invention has the beneficial effects that:

1. the material of the invention is synthesized by active anion polymerization, has narrow molecular weight distribution, and does not contain oligomer which is easy to filter out when being implanted into a human body.

2. The heat-crosslinkable elastic material prepared by the invention uses active anion polymerization and selective catalytic hydrogenation, and the polymer only contains two elements of carbon and hydrogen and does not contain halogen, so that the polymer does not corrode equipment or generate defects during processing.

3. The invention uses active anion polymerization, uses cheap n-butyl lithium as initiator, and the polymerization temperature is about 50-90 ℃. Although selective catalytic hydrogenation is required, such polymer synthesis process still makes the polymer relatively low cost, and easily realizes the expanded production.

4. The living anion polymerization has more flexible molecular design, and the selection range of monomers, the construction mode of polymers, the polymerization controllability and the like are greatly superior to those of the living cation polymerization.

5. The elastic material obtained by anionic polymerization has excellent mechanical property and higher tensile strength.

6. The rubber phase (i.e., the soft segment) of the material of the present invention contains a conjugated diene. After polymerization, the polymer can saturate the double bonds remained on the conjugated diene monomer units through selective hydrogenation, thereby having better stability and a plurality of more excellent mechanical properties. Meanwhile, the thermal crosslinking monomer contained in the polymer is not influenced by active anion polymerization and selective catalytic hydrogenation, so that the chemical crosslinking can be formed by heating (about 240 ℃ for about 20 minutes) after the polymer is hydrogenated.

7. The elastomeric material has been purified of various impurities (including catalysts, solvents, and other impurities) prior to crosslinking; chemical crosslinking can take place upon heating without the addition of any other substances such as catalysts and without the release of any small molecule substances. Chemical crosslinking can improve the dimensional stability of the material under high temperature and stress.

8. The elastic material is completely nonpolar, does not absorb moisture, does not have a group capable of being hydrolyzed and degraded, and has no unstable double bond in a molecular structure after selective hydrogenation, so that the elastic material has good high-temperature oxidation resistance, biological stability and biocompatibility.

9. Scarring is effectively reduced through the biocompatibility of the material, the minimally invasive surgery path and the wound brought by the implantation device and the drug-loading characteristic of the material. And further effectively prevent aging and deformation through the cross-linking process of the material;

10. the expansion section at the near end of the tube body, the two inner tubes led out of the outer tube body at the far end of the tube body and the pits distributed on the outer surface of the tube body keep the tube body well fixed, and the position change in the eyes is avoided;

11. the intraocular pressure is controlled by the selection of the pipe diameter and the combination of two parallel inner pipes, so that the problems of low intraocular pressure and superficial anterior chamber are effectively avoided, and the blockage is prevented.

Drawings

FIG. 1 is a schematic view of an embodiment of a glaucoma drainage tube in a contracted state;

FIG. 2 is a schematic view of a natural state of an embodiment of a glaucoma drainage tube;

FIG. 3 is a schematic view of an embodiment of a glaucoma drainage tube in a contracted state;

FIG. 4 is a schematic view of the natural state of a glaucoma drainage tube of an embodiment of the present invention;

FIG. 5 is a schematic view of a glaucoma drainage tube implanting device;

FIG. 6 is a schematic illustration of a glaucoma drainage tube prior to insertion;

FIG. 7 is a nuclear magnetic hydrogen spectrum of an elastomeric material of the first material before and after hydrogenation;

FIG. 8 is a GPC chart of the elastomer before and after hydrogenation in material one.

In the figure: 1-outer tube, 2-inner tube, 3-expansion section, 4-outer shell, 5-upper part, 6-lower part, 7-tail cover, 8-needle head, 9-connecting section, 10-base, 11-pushing rod, 12-pushing needle, 13-first sliding groove, 14-second sliding groove, 15-first sliding convex edge, 16-second sliding convex edge, 17-rotary cylinder, 18-thread section, 19-sliding section, 20-stepped hole, 21-annular groove, 22-first annular convex edge, 23-second annular convex edge and 24-window.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail below with reference to the accompanying drawings.

The preparation of the drainage tube can adopt the following application numbers: 202010045485.1 entitled "thermally crosslinkable elastomeric materials synthesized by anionic polymerization and uses thereof", the thermally crosslinkable triblock polymer elastomeric materials of this patent application can be used, for example, as follows:

the material I for manufacturing the glaucoma drainage tube comprises the following components:

a thermally crosslinkable triblock polymer elastomeric material: the product obtained by selective hydrogenation of (styrene-co-4 VBCB) -polyisoprene-poly (styrene-co-4 VBCB) has the following molecular structural formula:

the preparation method comprises the following steps:

(1) The polymerization process comprises the following steps: preparing a styrene/4 VBCB mixture in advance (the weight of the 4VBCB is 2 percent of the weight of the mixture); adding 1000mL solvent cyclohexane (water content is 10ppm) into a polymerization kettle, and heating to 70 ℃; styrene/4 VBCB mixture (16.5mL) and 0.50mL n-butyllithium (n-hexane solution with the concentration of 1.6M) are added in sequence to react for 15 minutes; adding 103mL of isoprene, and reacting for 30 min; then 16.5mL of styrene/4 VBCB mixture was added, and after reacting for 30min, isopropanol was added to terminate the polymerization reaction.

(2) Selective catalytic hydrogenation process: 1.25g of nickel isooctanoate is added into a single-neck flask, dissolved by 57mL of cyclohexane, and then 9.3mL of triisobutylaluminum (1.1M toluene solution) is slowly dropped and mixed uniformly, and the mixture is a catalyst for selective hydrogenation; transferring the polymer solution after the polymerization termination to a hydrogenation kettle at 70 ℃, adding the prepared catalyst, increasing the pressure to 1.8MPa by using hydrogen while fully stirring, and continuously supplementing the pressure by using the hydrogen until the hydrogenation is completed.

(3) Hydrogenated polymer cleaning process: transferring the hydrogenated polymer solution into a water washing kettle at 70 ℃, adding 30mL of hydrogen peroxide (30 percent), and mixing for 30 min; adding 3% citric acid solution (1L), mixing for 1 hr, and separating to remove citric acid solution; continuously extracting once with 1L of citric acid solution, and separating the citric acid solution; washing the polymer solution with deionized water to neutrality; and precipitating the washed polymer in isopropanol, and drying the polymer in vacuum to constant weight to obtain a final hydrogenation product, namely the thermal-crosslinkable elastic material.

(4) Thermal crosslinking reaction: the elastic material was compression molded at 240 ℃ for 20 minutes and the resulting material was no longer soluble in toluene (only swelling occurred), indicating that a crosslinking reaction occurred.

FIG. 7 is a nuclear magnetic hydrogen spectrum of the elastomer before and after hydrogenation showing that residual double bonds (about 4.5-5.2ppm) of isoprene monomer units are substantially saturated after selective catalytic hydrogenation with a degree of hydrogenation of 95.2% while benzocyclobutene groups of thermally crosslinked monomer units remain (about 3.1 ppm).

FIG. 8 is a GPC chart of the elastomer before and after hydrogenation showing that the molecular weight distribution before and after hydrogenation is substantially unchanged.

The invention relates to a material II for manufacturing a glaucoma drainage tube:

a thermally crosslinkable triblock polymer elastomeric material: the molecular structure of the product after selective hydrogenation of (styrene-co-4 VBCB) -polybutadiene-poly (styrene-co-4 VBCB) is as follows:

the preparation method comprises the following steps:

(1) the polymerization process comprises the following steps: preparing a styrene/4 VBCB mixture in advance (the weight of the 4VBCB is 2 percent of the weight of the mixture); adding 450mL solvent cyclohexane (water content is 10ppm) into a polymerization kettle, and heating to 75 ℃; styrene/4 VBCB mixture (6.9mL) and 0.13mL n-butyllithium (n-hexane solution with the concentration of 1.6M) were sequentially added to react for 15 minutes; adding 39.5g of butadiene, and reacting for 30 min; 6.9mL of a styrene/4 VBCB mixture was added, and after reacting for 20 minutes, isopropanol was added to terminate the polymerization reaction.

(3) Hydrogenated polymer cleaning process: the same cleaning procedure as in example 1.

(4) Thermal crosslinking reaction: the elastomeric material was molded at 240 degrees celsius for 30 minutes and the resulting material was no longer soluble in toluene (only swelling occurred), indicating that a crosslinking reaction occurred.

The nuclear magnetic hydrogen spectrum of the hydrogenated elastic material shows that the residual double bonds of the butadiene monomer units are completely saturated after selective catalytic hydrogenation, and the hydrogenation degree is 100 percent.

As shown in fig. 1 and 2, the first embodiment discloses a glaucoma drainage tube, which comprises an outer tube 1 and inner tubes 2, wherein the two inner tubes 2 are fixedly arranged in the outer tube 1 side by side, the outer tube 1 and the inner tubes 2 are made of the above-mentioned materials, the distal ends of the inner tubes 2 extend to the outside of the outer tube 1, the outer wall of the outer tube 1 is provided with pits, a plurality of pits are distributed in an array,

The outer wall of the outer tube 1 is loaded with a drug therapeutic agent which is mitomycin C or 5-fluorouracil.

In a natural state, the distal end of the inner tube 2 is arc-shaped, the axial distance between the tail part of the inner tube 2 and the outer tube 1 is gradually increased from the beginning to the end,

in the contracted state, the distance between the edge of the far end of the inner tube 2 far away from the axial direction of the outer tube 1 and the axial direction of the outer tube 1 is less than or equal to the outer diameter of the outer tube, and as shown in fig. 2, the tail part of the inner tube 2 is parallel to the axial direction of the outer tube 1.

A typical volume of the anterior chamber of the human eye is about 2mL, with a normal rate of aqueous humor production of 2.5 μ L/min. In glaucoma surgery, the desired intracameral pressure is generally greater than or equal to 14mmHg to avoid problems of low intraocular pressure and superficial anterior chamber, the typical backpressure of the bleb is 4-8 mmHg, and the median is 6 mmHg. According to the Hagen-Poiseuille formula of steady fluid dynamics in round tubes:

wherein q is _v The speed of the aqueous humor in the round tube; r is the radius of the round pipe; eta is viscosity coefficient of aqueous humor, here, 6.2512732 × 10 ^-4 The lower limit of the inner diameter of the inner tube 2, corresponding to the pressure unit mmHg, the flow unit μ L/min, and the length unit mm, can be calculated as: 45 μm, corresponding to an inner tube 2 length of 11 mm.

Considering that glaucoma in chinese is often found in the middle and late stages, the baseline intraocular pressure is generally high, a larger inner diameter of the inner tube 2 is required to drain the aqueous humor accumulated in the anterior chamber within a certain time after the drainage tube is implanted, and an appropriate increase in the inner diameter of the inner tube 2 to 60 μm is required due to potential bending of the tube inside the eye and potential collagen cell deposition problems after a long period of implantation. This diameter allows for no risk of hypotony in case both inner tubes 2 are working at the same time. Meanwhile, if one inner tube 2 is blocked, the risk of high intraocular pressure is avoided.

As shown in fig. 3 and 4, the glaucoma drainage tube disclosed in the second embodiment is different from the glaucoma drainage tube disclosed in the first embodiment in that the outer tube 1 is provided at a proximal end thereof with an expansion section 3, the expansion section 3 is a fixing device,

in a natural state, the outer diameter of the expansion section 3 is larger than that of the outer pipe,

in the contracted state, the outer diameter of the expansion end 3 is equal to the outer diameter of the outer pipe,

in order to realize the contraction/expansion function of the expansion section 3, the proximal end of the outer pipe 1 is in sliding fit with the proximal end of the inner pipe 2.

As shown in fig. 5 to 6, the invention also discloses an implantation device of the glaucoma drainage tube, which comprises the drainage tube, a shell 4, a puncture component and a pushing component;

the tail part of the shell 4 is detachably connected with a tail cover 7, a window 24 is arranged on the side wall of the shell 4, a rotating cylinder 17 is coaxially arranged in the shell 4, a positive rotating thread is arranged on the inner wall of the top of the rotating cylinder 17, a negative rotating thread is arranged on the inner wall of the bottom of the rotating cylinder 17, the rotating cylinder 17 is in rotating fit with the inner wall of the shell 4, a first sliding groove 13 is arranged on the inner wall of the top of the shell 4, a second sliding groove 14 is arranged on the inner wall of the bottom of the shell 4, and the first sliding groove 13 and the second sliding groove 14 are both axially arranged along the shell 4;

the puncture assembly comprises a needle head 8, a connecting section 9 and a base 10 which are coaxially arranged from top to bottom in sequence, a first sliding convex ridge 15 is arranged on the outer wall of the base 10, the first sliding convex ridge 15 is matched with a first sliding chute 13, the top of a rotary cylinder 17 is sleeved on the periphery of the bottom of the base 10, the rotary cylinder 17 is in threaded connection with the base 10, and a drainage tube is arranged at the top of an inner cavity of the needle head 8;

The push assembly comprises a push rod 11, a push needle 12 is arranged at the top end of the push rod 11, the top end of the push needle 12 is inserted into the bottom of a needle head 8, the push needle 12 is slidably connected with the needle head 8, the top of the push rod 11 penetrates through a base 10, a thread section 18 is arranged in the middle of the push rod 11, the periphery of the thread section 18 is in threaded connection with the bottom of a rotary drum 17, a second sliding convex rib 16 is arranged at the tail of the push rod 11, and the second sliding convex rib 16 is matched with a second sliding groove 14.

The tail end of the push rod 11 penetrates through the tail cover 7, the tail end of the push rod 11 extends out of the tail cover 7, and scale marks are arranged at the tail part of the push rod 11, so that a user can observe the pushing depth of the drainage tube conveniently.

The housing 4 comprises an upper part 5 and a lower part 6, and a window 24 is positioned at the bottom end of the upper part 5, so that the assembly can be conveniently installed.

5 bottom inner walls in upper portion are equipped with

shoulder hole

20, and 6 top inner walls in lower part are equipped with ring channel 21, and a rotatory 17 top periphery is equipped with first annular protruding stupefied 22, and a rotatory 17 bottom periphery is equipped with the protruding stupefied 23 of second annular, and the protruding stupefied 22 adaptation shoulder hole 20 of first annular, the protruding stupefied 23 adaptation ring channel 21 of second annular can make a rotatory 17 position relatively fixed, prevents the drunkenness in the use.

Catch bar 11 bottom is equipped with

slip section

19, 19 peripheries of slip section and 4 inner walls sliding fit of shell, and 19 peripheries of slip section are located to protruding stupefied 16 of second slip, further improve catch bar 11's stability, prevent to rock.

The top end of the push needle 12 is of a round and blunt structure, so that the damage to the drainage tube can be reduced.

As shown in fig. 1-6, before actual use, the drainage tube is placed at the top of the inner cavity of the needle 8, and the implantation device is installed, and at this time, the distance between the bottom surface of the base 10 and the top surface of the threaded section 18 is at least greater than the length of the drainage tube;

when the drainage device is used, the needle head 8 penetrates through the sclera, the rotating cylinder is rotated, at the moment, the needle head 8 retracts due to the fact that threads with different rotation directions are arranged in the rotating cylinder, the pushing needle 12 pushes, the drainage tube can be placed in human tissues while the needle head 8 is retracted, at the moment, the needle head 8 already leaves from the human tissues, and the implantation device is removed.

The present invention is capable of other embodiments, and various changes and modifications may be made by one skilled in the art without departing from the spirit and scope of the invention.

Claims

1. An implantation device of a glaucoma drainage tube, which is characterized in that: comprises a glaucoma drainage tube, a shell (4), a puncture component and a pushing component;

the glaucoma drainage tube comprises an outer tube and inner tubes, wherein the two inner tubes are fixedly arranged in the outer tube side by side, and the outer tube and the inner tubes are made of thermally crosslinkable triblock polymer elastic materials;

The tail of the shell (4) is detachably connected with a tail cover (7), a window (24) is formed in the side wall of the shell (4), a rotating cylinder (17) is coaxially arranged in the shell (4), a forward-rotating thread is arranged on the inner wall of the top of the rotating cylinder (17), a backward-rotating thread is arranged on the inner wall of the bottom of the rotating cylinder (17), the rotating cylinder (17) is in rotating fit with the inner wall of the shell (4), a first sliding groove (13) is formed in the inner wall of the top of the shell (4), a second sliding groove (14) is formed in the inner wall of the bottom of the shell (4), and the first sliding groove (13) and the second sliding groove (14) are both axially arranged along the shell (4);

the puncture assembly comprises a needle head (8), a connecting section (9) and a base (10) which are coaxially arranged from top to bottom in sequence, a first sliding convex edge (15) is arranged on the outer wall of the base (10), the first sliding convex edge (15) is matched with a first sliding groove (13), the top of a rotary cylinder (17) is sleeved on the periphery of the bottom of the base (10), the rotary cylinder (17) is in threaded connection with the base (10), and a drainage tube is arranged at the top of an inner cavity of the needle head (8);

the pushing assembly comprises a pushing rod (11), a pushing needle (12) is arranged at the top end of the pushing rod (11), the top end of the pushing needle (12) is inserted into the bottom of a needle head (8), the pushing needle (12) is connected with the needle head (8) in a sliding mode, a base (10) is penetrated through the top of the pushing rod (11), a thread section (18) is arranged in the middle of the pushing rod (11), the periphery of the thread section (18) is connected with the bottom of a rotating cylinder (17) in a threaded mode, a second sliding convex rib (16) is arranged at the tail of the pushing rod (11), and the second sliding convex rib (16) is matched with a second sliding groove (14).

2. The implant device of claim 1, wherein: the tail end of the push rod (11) penetrates through the tail cover (7), the tail end of the push rod (11) extends out of the tail cover (7), and the tail part of the push rod (11) is provided with scale marks.

3. The implant device of claim 1, wherein: shell (4) include upper portion (5), lower part (6), window (24) are located upper portion (5) bottom, upper portion (5) bottom inner wall is equipped with shoulder hole (20), lower part (6) top inner wall is equipped with ring channel (21), rotatory section of thick bamboo (17) top periphery is equipped with protruding stupefied (22) of first annular, rotatory section of thick bamboo (17) bottom periphery is equipped with protruding stupefied (23) of second annular, protruding stupefied (22) adaptation shoulder hole (20) of first annular, protruding stupefied (23) adaptation ring channel (21) of second annular.

4. The implant device of claim 1, wherein: the near end of the outer pipe is provided with an expansion section,

5. The implant device of claim 1, wherein: the distal end of the inner tube extends to the outside of the outer tube,

in a natural state, the axial distance between the far end of the inner tube and the outer tube is gradually increased from the beginning to the end,

in the contraction state, the distance between the edge of the far end of the inner pipe far away from the axial direction of the outer pipe and the axial direction of the outer pipe is less than or equal to the outer diameter of the outer pipe.

6. The implant device of claim 1, wherein: the outer wall of the outer tube (1) is provided with pits, a plurality of pits are distributed in an array,