CN218739322U - Porous silica gel glaucoma drainage device - Google Patents
Porous silica gel glaucoma drainage device Download PDFInfo
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- CN218739322U CN218739322U CN202122823864.1U CN202122823864U CN218739322U CN 218739322 U CN218739322 U CN 218739322U CN 202122823864 U CN202122823864 U CN 202122823864U CN 218739322 U CN218739322 U CN 218739322U
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Abstract
The utility model relates to a porous silica gel glaucoma drainage device, which consists of a drainage tube and a water drainage unit. The aqueous humor discharging unit consists of an aqueous humor discharging one-way valve and a porous arc-shaped plate, the aqueous humor discharging one-way valve is connected with the drainage tube, and fixing holes and drainage holes are distributed on the porous arc-shaped plate. The porous silicone tube is embedded in the fixing hole, so that tissue cells can easily grow into the hole, a good fixing effect can be provided for the glaucoma drainage device, and the problem of displacement of the drainage device is solved; the inner wall of the drainage hole is coated with the mitomycin C drug coating, so that scar formation of tissues in the filtering passage can be avoided, and the capsule cavity is prevented from being coated.
Description
Technical Field
The utility model relates to the technical field of medical equipment, concretely relates to porous silica gel glaucoma drainage ware.
The background art comprises the following steps:
glaucoma (glaucoma) is one of three major blinding diseases of the eye worldwide, and is an irreversible eye injury disease. Glaucoma is mainly caused by the increase of intraocular pressure caused by the poor circulation of aqueous humor, and is manifested by symptoms of increased intraocular pressure, visual field defect, visual deterioration, atrophy of optic papilla and the like, and seriously threatens the physical health of patients. The current preferred mode for treating refractory glaucoma at home and abroad is drainage implant.
The current glaucoma drainage thing is drainage ware for implantation mainly has 3: (1) The glaucoma drainage valve consists of 1 silicone tube and 1 silicone end plate, the silicone tube is inserted into the anterior chamber (or into a vitreous cavity or a ciliary sulcus under some conditions) through scleral fistula, and divides aqueous humor to 1 end plate (the end plate is arranged in the gap between the equator and the tenon of an eyeball) to form an aqueous humor accumulation pool, and finally the aqueous humor is diffused to tissues at the back of the eyeball and absorbed by capillary vessels and lymphatic vessels, so that intraocular pressure is reduced. (2) The EX-press glaucoma drainage device consists of a drainage device and an introducer, wherein after the corneal limbus determines a puncture position, the drainage device is released through the introducer, the head end enters the anterior chamber, and the tail end is placed under the sclera to form a new aqueous humor drainage channel. (3) The XeN glaucoma drainage tube consists of degradable pigskin gelatin, is pre-filled in a syringe and is released by the syringe when in use.
However, the problems of displacement of the drainage device, scar formation of the filter channel, end plate fiber sac cavity wrapping and the like exist after the existing glaucoma drainage device is operated, so that the drainage device cannot conduct drainage, the drainage of aqueous humor is not smooth, the intraocular pressure is increased, and the final operation fails, so that the drainage device for treating refractory glaucoma is urgently needed, and the technical problems of displacement of the drainage device, scar formation and fiber sac cavity wrapping in the glaucoma treatment process are solved.
SUMMERY OF THE UTILITY MODEL
The utility model aims at providing a porous silica gel glaucoma drainage device capable of being organized and fixed so as to solve the problems mentioned in the background.
In order to achieve the above object, the utility model provides a following technical scheme:
a porous silica gel glaucoma drainage device comprising: the drainage device comprises a drainage tube and an aqueous humor discharging unit, wherein the aqueous humor discharging unit consists of an aqueous humor discharging one-way valve and a porous arc-shaped plate, the aqueous humor discharging one-way valve is fixed at one end of the porous arc-shaped plate, and fixing holes and drainage holes are distributed on the porous arc-shaped plate; a porous silica gel tube is embedded in the fixing hole, an antimetabolite coating is coated on the inner wall of the drainage hole, and the types of the antimetabolite coating on the inner wall of the drainage hole comprise mitomycin C, 5-fluorouracil, pirfenidone, lovastatin, rapamycin target protein, rosiglitazone, amsacrine and the like; the drainage tube is fixed at one end of the porous arc-shaped plate close to the aqueous humor discharge one-way valve through bonding.
The aqueous humor discharge unit and the drainage tube are made of silicon rubber materials.
The porous arc-shaped plate is arc-shaped, conforms to the radian of the sclera edge of the eyeball, and has a surface area of 90-182mm 2 The thickness is 0.5-2mm.
The inner diameter of the drainage tube is 0.4-0.7mm, and the outer diameter is 0.7-1mm.
The inner diameter of the fixing hole is 1.6-2.4mm.
The diameter of the porous silica gel tube is 1.2-2.2mm, and the inner diameter is 1-2mm.
The inner diameter of the drainage hole is 0.2-0.4mm, and the concentration of the antimetabolite coating on the inner wall of the drainage hole is 0.1-0.2mg/mL.
The utility model discloses following outstanding beneficial effect has:
a porous cross design is adopted, a porous silicone tube is arranged in the fixing hole, scleral tissues can grow on the porous silicone tube, and the drainage device is fixed, so that the problem of displacement of the drainage device is solved; the inner wall of the drainage hole is provided with an antimetabolite coating, which can prevent scar formation, slow down the formation of fibrovesicle and maintain the smooth passage.
Drawings
Fig. 1-4 are schematic views of a porous silica gel glaucoma drainage device, in which:
FIG. 1 is a schematic view of the overall structure of a porous silica gel glaucoma drainage device;
FIG. 2 is a schematic longitudinal cross-sectional view of a fixation hole;
FIG. 3 is a top view of the fixing hole;
fig. 4 is a schematic view of the overall structure of a non-porous silica gel glaucoma drainage device;
fig. 5 is a schematic view of the overall construction of the non-stationary glaucoma drainage device;
FIG. 6 is a graph of the proportion of tissue in-depth versus time;
figure 7 is a graph of functional bleb survival versus time.
Detailed Description
The technical solution of the present invention will be further described in detail with reference to the accompanying drawings and specific embodiments.
Referring to fig. 1, a porous silica gel glaucoma drainage device includes: fourth, the drainage tube and the room water discharging unit. The room water discharge unit includes the fixing hole, the drainage hole, the room water discharge one-way valve and the porous arc wall of the fifth.
The porous silicone tube is embedded in the fixing hole, the specific embedding mode is shown in fig. 2, and the specific appearance is shown in fig. 3. The porous silicone tube has good biocompatibility, the porous structure of the porous silicone tube is easy for the infiltration growth of scleral tissues, and the porous silicone tube has a good fixing function.
And a layer of mitomycin C coating is loaded on the inner wall of the drainage hole. Compared with the prior art, the mitomycin C coating has a good function of inhibiting the growth of tissue cells, prevents the scar of a filter passage, delays the aqueous humor discharging unit from being wrapped by a sac cavity, and keeps the filter passage smooth.
As shown in fig. 1, the aqueous humor discharging unit is formed by bonding a drainage tube;
the specific experimental scheme is as follows: 50 adult New Zealand white rabbits, weighing 2.5-3.0kg, were female, were randomly divided into 5 groups of 10 according to the observation time, and 1 glaucoma drainage device was implanted per one according to the experimental requirements. Before the operation, an operator uses normal saline to wash the porous silica gel glaucoma drainage device smoothly for later use. A conventional ophthalmic sterile drape was infiltrated with 2% lidocaine 3.0 mL balls for anesthesia. 0.4mg/mL mitomycin C5 min is placed under the bulbar conjunctiva at a position 8mm away from the limbus of the superior temporal quadrant or the superior nasal quadrant, a fornix-shaped incision is made through the conjunctiva and the Tenon's sac, the Tenon's sac and the surface layer of the sclera are separated bluntly to form a pocket, the aqueous humor discharging unit is placed into the pocket, and the aqueous humor discharging unit is sutured on the surface layer of the sclera by a polylactic acid suture thread through the drainage hole and the ampulla. And a 5-point or 7-point corneal limbus is provided with an anterior chamber puncture opening for standby, and then the distal end of the drainage tube is trimmed to be an inclined plane which faces upwards by 30 degrees and is placed into the anterior chamber by 2-3mm along the puncture opening. The exposed drainage tube was covered with a 6 × 4mm or more graft scleral flap, and the conjunctival flap was sutured. The eyes were observed under slit lamp microscope at 1, 2, 3, 6, 9, 12 months after surgery, the number of surviving functional blebs was recorded and the survival rate was calculated. After operation, the experimental rabbits are killed in 3, 6, 9, 12 and 15 months, the materials are taken, fixed by 4 percent formaldehyde, washed, dehydrated, embedded by paraffin, and naturally solidified in a refrigerator at 4 ℃. The slices are continuously and parallelly sliced, and the slices with the diameter of (16 +/-1) mm (the cross section is made through the center of the fixed hole) are taken, and the thickness is about 200 mu m. Grinding to about 50 μm, polishing, staining with hematoxylin-eosin, performing qualitative observation, and calculating the tissue growth depth ratio. Tissue in depth ratio = tissue in depth/length of porous silica tube.
Comparative example 1: as shown in fig. 4, the specification of the drainage tube of the glaucoma drainage device without the porous silica gel tube can be 0.5mm in outer diameter and 0.3mm in inner diameter. The aqueous humor discharge check valve is composed of two silica gel films, and the length of the valve can be 8mm, and the width of the valve can be 7mm. The specification of the fixing hole can be selected to be 1.8mm in inner diameter. The inner diameter of the drainage hole is 0.4mm, and the concentration of the mitomycin C drug coating on the inner wall of the drainage hole can be 0.1mg/mL. The radian of the porous arc plate conforms to the radian of the corneoscleral edge, and the surface area is 180mm 2 The thickness is 1mm.
Comparative example 2: as shown in fig. 5, the non-fixed glaucoma drainage device can be selected from drainage tubes with the specification of 0.5mm of outer diameter and 0.3mm of inner diameter. The aqueous humor discharge check valve is composed of two silica gel films, and the length of the valve can be 8mm, and the width of the valve can be 7mm. The inner diameter of the drainage hole is 0.4mm, and the concentration of the mitomycin C drug coating on the inner wall of the drainage hole can be selected to be 0.1mg/mL. The radian of the porous arc plate conforms to the radian of the corneoscleral edge, and the surface area is 180mm 2 The thickness is 1mm.
Example 1: as shown in figure 1, the specification of the drainage tube of the porous silica gel glaucoma drainage device can be 0.5mm in outer diameter and 0.3mm in inner diameter. The aqueous humor discharge check valve is composed of two silica gel films, and the length of the valve can be 8mm, and the width of the valve can be 7mm.
The specification of the fixing hole can be selected to be 1.6mm in inner diameter. The diameter of the porous silica gel tube is 1.2mm, and the inner diameter of the porous silica gel tube is 1mm.
The inner diameter of the drainage hole is 0.4mm, and the concentration of the mitomycin C drug coating on the inner wall of the drainage hole can be selected to be 0.1mg/mL.
The radian of the porous arc-shaped plate conforms to the radian of the corneosclera edge, and the surface area is 180mm 2 The thickness is 1mm.
Example 2: as shown in figure 1, the specification of the drainage tube of the porous silica gel glaucoma drainage device can be 0.5mm in outer diameter and 0.3mm in inner diameter. The aqueous humor discharge check valve is composed of two silica gel films, and the length of the valve can be 8mm, and the width of the valve can be 7mm.
The fixed orifices specification can choose the internal diameter to be 2mm. The diameter of the porous silica gel tube is 1.8mm, and the inner diameter of the porous silica gel tube is 1.6mm.
The inner diameter of the drainage hole is 0.4mm, and the concentration of the mitomycin C drug coating on the inner wall of the drainage hole can be selected to be 0.1mg/mL.
The radian of the porous arc plate conforms to the radian of the corneoscleral edge, and the surface area is 180mm 2 The thickness is 1mm.
Example 3: as shown in figure 1, the specification of the drainage tube of the porous silica gel glaucoma drainage device can be 0.5mm in outer diameter and 0.3mm in inner diameter. The aqueous humor discharge check valve is composed of two silica gel films, and the length of the valve can be 8mm, and the width of the valve can be 7mm.
The specification of the fixing hole can be 2.4mm in inner diameter. The diameter of the porous silica gel tube is 2.2mm, and the inner diameter of the porous silica gel tube is 2mm.
The inner diameter of the drainage hole is 0.4mm, and the concentration of the mitomycin C drug coating on the inner wall of the drainage hole can be 0.1mg/mL.
The radian of the porous arc plate conforms to the radian of the corneoscleral edge, and the surface area is 180mm 2 The thickness is 1mm.
The specific test results are shown in table 1:
TABLE 1 tissue ingrowth depth ratio at different times after surgery
According to animal experiment results, tissues can permeate and grow into the fixing holes of the porous silica gel glaucoma drainage device, a good fixing function is achieved, and the problem that the drainage device is displaced in the glaucoma treatment process is solved.
The specific test results are shown in table 2:
TABLE 2 number of functional filtration blisters at different times after operation
As can be seen from the test results in table 2 and fig. 7, the survival rate of the functional number of filtration blisters is higher in 1-3 months, the survival rate of the functional number of filtration blisters is lower in comparative example 2 after 3 months of operation, and the survival rate of the functional number of filtration blisters is higher in the examples, which indicates that the porous silica gel glaucoma drainage device can keep the clear passage of the filtration passage for a long time, and solve the problem of scarring of the filtration passage.
Claims (7)
1. The utility model provides a porous silica gel glaucoma drainage ware, a serial communication port, porous silica gel glaucoma drainage ware is bonded by a drainage tube and a room water discharge unit and is constituteed, room water discharge unit includes room water discharge one-way valve three and porous arc wall two parts, room water discharge one-way valve three bond with the drainage tube and link to each other, porous arc wall is distributed fixed hole.
2. The porous silica gel glaucoma drainage device of claim 1, wherein the inner diameter of the fixing hole is 1.6-2.4mm.
3. The porous silica gel glaucoma drainage device of claim 1, wherein the diameter of the silicone tube is 1.2-2.2mm, and the inner diameter is 1-2mm.
4. The porous silica gel glaucoma drainage device according to claim 1, wherein the drainage tube has an inner diameter of 0.4-0.7mm and an outer diameter of 0.7-1mm.
5. The porous silica gel glaucoma drainage device of claim 1, wherein the drainage holes have a vertical internal diameter of 0.2-0.4mm.
6. The porous silica gel glaucoma drainage device of claim 1, wherein the drainage holes have two inner wall drug coating types including mitomycin C.
7. The porous silica gel glaucoma drainage device of claim 1, characterized in that the porous arc plate is arc-shaped, and the surface area is 90-182mm 2 The thickness is 0.5-2mm.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202122823864.1U CN218739322U (en) | 2021-11-18 | 2021-11-18 | Porous silica gel glaucoma drainage device |
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| CN202122823864.1U CN218739322U (en) | 2021-11-18 | 2021-11-18 | Porous silica gel glaucoma drainage device |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113925676A (en) * | 2021-11-18 | 2022-01-14 | 山东百多安医疗器械股份有限公司 | Porous silica gel glaucoma drainage device |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113925676A (en) * | 2021-11-18 | 2022-01-14 | 山东百多安医疗器械股份有限公司 | Porous silica gel glaucoma drainage device |
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