WO2007085131A1 - Sac capsulaire de corps vitré artificiel et procédé pour le produire - Google Patents

Sac capsulaire de corps vitré artificiel et procédé pour le produire Download PDF

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Publication number
WO2007085131A1
WO2007085131A1 PCT/CN2006/000311 CN2006000311W WO2007085131A1 WO 2007085131 A1 WO2007085131 A1 WO 2007085131A1 CN 2006000311 W CN2006000311 W CN 2006000311W WO 2007085131 A1 WO2007085131 A1 WO 2007085131A1
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Prior art keywords
bag
capsular bag
artificial vitreous
vitreous
less
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PCT/CN2006/000311
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English (en)
French (fr)
Inventor
Qianying Gao
Shansong Mu
Original Assignee
Zhongshan Ophthalmic Center, Sun Yat-Sen University
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Publication of WO2007085131A1 publication Critical patent/WO2007085131A1/zh

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Classifications

    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body

Definitions

  • the invention relates to a medical biological material, in particular to an artificial glass body bag and a manufacturing process thereof.
  • vitreous substitutes A normal vitreous is a gelatinous tissue that cannot be regenerated. After vitrectomy, a vitreous substitute is needed to fill the vitreous cavity and support or fill the retina to prevent retinal detachment.
  • inert gas silicone oil, heavy silicone oil, perfluorocarbon liquid, and polymer hydrophilic polymer hydrogels which were researched at home and abroad in the 1990s.
  • their therapeutic effects are not ideal, and some can cause serious complications.
  • an inert gas such as C3F8 is prone to cataract, which loses its filling effect about two weeks after surgery and does not produce a permanent pressure on the retina.
  • Perfluorocarbon liquid is toxic to the retina and cannot be left in the vitreous cavity for a long time. It is used intraoperatively and easily remains in the eye. It is more difficult to remove after reaction with water. Currently, a wide range of silicone oil substitutes can cause cataracts and glaucoma, and it will emulsifie in a certain period of time.
  • Hydrogels mainly include PVP hydrogels, PVA hydrogels, PAM hydrogels, and polyvinylpyrrolidone hydrogels.
  • PVP hydrogels PVA hydrogels
  • PAM hydrogels PAM hydrogels
  • polyvinylpyrrolidone hydrogels are still in the experimental stage in ophthalmology, and so far no hydrogel has entered.
  • Clinical application lack of long-term efficacy observation of intraocular toxicity, and the price is very expensive, the patient is difficult to afford. Finding a more physiologically and economically vitreous substitute is imperative and one of the problems that has plagued vitreoretinal diseases in this century.
  • the invention patent No. ZL03126845. 5 discloses a technical solution of a bag-type artificial glass body, which uses an artificial vitreous system composed of a polymer film bag filled with water and carrying a drainage valve to achieve the purpose of supporting the retina and preventing re-dissemination of the retina.
  • the technical solution of the invention also has the defects of low biocompatibility and poor elasticity.
  • the object of the present invention is to overcome the deficiencies of the prior art and provide an artificial vitreous enamel bag with high biocompatibility and good elasticity and a manufacturing process thereof.
  • Artificial vitreous helium bags are mainly made of polysiloxane.
  • the wall thickness of the bag is less than 50 ⁇ ⁇
  • the Shore hardness of the bag is 30 - 40 degrees
  • the tensile strength is 4 - 7Mpa
  • the hemolysis rate of the material is less than 5%
  • the light transmittance is higher than 90%
  • the haze is less than 0. 1%
  • elongation is greater than 1000. /.
  • tear strength is 30 - 40kN/m o
  • the manufacturing process of the artificial vitreous pocket includes:
  • the enamel bag of the invention adopts a modified silicone elastomer, which has high biocompatibility and good elasticity. After the animal experiment was implanted into the artificial vitreous system, it was confirmed by electrophysiology, light microscopy and electron microscopy that it was easy to be implanted and removed, and there was no obvious tissue toxicity in the eye.
  • the manufacturing process uses a dip-forming process to effectively improve the smoothness of the inner surface of the crucible.
  • the artificial vitreous system of the present invention consists of a modified silicone film pocket corresponding to the volume of the vitreous cavity, a drainage tube and a drainage valve.
  • the bag is filled with physiological saline, and the pressure of the bag that presses the retina is adjusted to an appropriate level, and the pressure can also be pumped.
  • the pressure can also be replenished with water.
  • the artificial vitreous helium bag is mainly made of polysiloxane.
  • the wall thickness of the bag is less than 50 ⁇ m.
  • the basic material of the artificial vitreous is 30-40 degrees, the tensile strength is 4-7 pa, and the elongation is The haze ratio is less than 5%, the light transmittance is higher than 90%, and the haze is less than 0.1%, the tearing strength is 30-40 kN / m.
  • the silicone elastomer is a transparent polymer which has no generation and escape of low molecular substances during vulcanization crosslinking, and has good biocompatibility, forming processability and elasticity.
  • the material In the biological evaluation experiment, there was a negative reaction, the material was not obviously toxic, and there was no potential allergenic substance in the material.
  • the content of the pyrogen contained in the material was in accordance with the requirements of the organism, and it was an ideal candidate for artificial vitreous.
  • the artificial vitreous body can be filled with water through a diverter valve to fill the pocket and adjust the pressure of the pocket.
  • the manufacturing process of the above artificial glass body bag applying the special mold of the human eye, the surface and the corner of the mold should be as smooth as possible to facilitate the smoothness of the inner surface of the enamel; the mold is slowly immersed in the glue, and the surface is attached with glue, and then repeated. Dip the glue 3-6 times, the action intensity and speed should be moderate, to prevent the occurrence of air bubbles; then the oven is heated and vulcanized, and peeled off to form the desired spherical outer ridge.
  • the glue is a silicone glue. Vulcanization conditions: temperature 80-120 ° C, time 0. 5-4 hours.
  • the artificial vitreous body does not have extensive contact with the ocular tissue, thereby avoiding the influence of the existing vitreous substitute on the anterior segment of the eye; individual patients with severe intraocular reactions are not It can be tolerated, and the artificial vitreous body can be easily taken out, so that the existing vitreous substitute can be prevented from remaining in the eye due to difficulty in taking out.
  • the bag Due to the expansion of the hook, the bag can have a permanent compression effect on the retinal tears in any part, reducing the chance of recurrence of retinal detachment, improving the surgical cure rate, and the patient does not need repeated operations, greatly reducing the economy. burden.

Description

人工玻璃体嚢袋及其制作工艺
[技术领域]
本发明涉及一种医用生物材料， 具体说是一种人工玻璃体嚢袋及其 制作工艺。
[背景技术〗
现代玻璃体手术是眼科治疗史上的一大革命， 使许多过去被认为不 治之症的眼疾获得治疗机会， 手术适应症也扩大到几十种眼病， 在眼科 临床中发挥了极大的作用， 挽救了无数即将失明的眼睛。
正常的玻璃体是一种不能再生的凝胶状组织。 在玻璃体切除手术 后, 需要用玻璃体替代物来填充玻璃侔腔， 支撑或填塞视网膜， 以防治 视网膜脱离。 目前国内外对玻璃体替代物研究众多， 主要有惰性气体、 硅油、 重硅油、 过氟化碳液体， 以及上世纪九十年代国内外研究热点的 高分子亲水性聚合物水凝胶等。 但它们的治疗效果均不甚理想， 有的能 引起严重的并发症。 如， 惰性气体如 C3F8 , 容易发生白内障， 在术后两 周左右失去填塞作用， 不能对视网膜产生持久的顶压作用； 过氟化碳液 体对视网膜有毒性， 不能长期留置在玻璃体腔,仅限于术中使用， 且容 易残留于眼内， 与水起反应后更难以取出； 目前临床应用比较广泛的硅 油替代物， 可引起白内障和青光眼， 且本身在一定的时间内会乳化， 乳
确 认 本 化后必须取出， 但取出后视网膜易发生再次脱离， 反复多次的手术， 不 仅加重了患者的经济负担，而且严重损害了患者的视力； 即使手术成功， 由于硅油屈光指数小， 对视网膜下方裂孔顶压效果差， 同时填充后必然 使眼球屈光度向高度远视方向改变， 因而患者的视力也非常差； 另外患 者术后必须是长期俯卧位， 以防止硅油流入前房， 因而患者非常痛苦。 水凝胶主要有 PVP 水凝胶、 PVA 水凝胶、 PAM水凝胶和聚乙烯吡咯烷酮 水凝胶等， 但这些水凝胶在眼科还处于实验阶段， 迄今为止还没有一种 水凝胶进入临床应用，对眼内毒性缺乏远期疗效观察，且价格非常昂贵， 患者难以负担。 寻找更符合生理、 更经济的玻璃体替代物势在必行， 也 是这个世纪困扰玻璃体视网膜疾病医生的难题之一。
如何制成一个结构和功能都与原始玻璃体相同的人工玻璃体是保 证玻璃体手术成功的关键因素之一。 玻璃体的成分目前还没有完全了 解， 在现有的科学技术条件下， 要求制作出形态和功能都很完美的人工 玻璃体是不切实际的。 因此， 改变研究思路， 不去追求制作完全生理性 的人工玻璃体， 而是先恢复玻璃体的最主要功能一支撑视网膜， 避免视 网膜反复脱离， 也是解决问题的一种办法。
现有的玻璃体替代物有时也称为人工玻璃体 , 植入方法均是在术中 将其直接注入到玻璃体腔， 来支撑视网膜， 防止视网膜再脱离。 专利号 为 ZL03126845. 5的发明专利公开了嚢袋式人工玻璃体的技术方案， 它应 用充填水并携带引流阀的高分子薄膜嚢袋组成的人工玻璃体系统来达 到支撑视网膜、 防止视网膜再脱离目的。 但该发明的技术方案还存在着 生物相容性较低、 弹性较差的缺陷。 [发明内容]
本发明的目的在于克服现有技术的不足之处， 提供一种生物相容性 较高、 弹性较好的人工玻璃体嚢袋及其制作工艺。
本发明的目的是这样实现的：
人工玻璃体嚢袋主要以聚硅氧烷为材料制作而成。嚢袋壁厚度小 于 50 μ ηι, 嚢袋的邵氏硬度为 30 - 40度， 拉伸强度为 4 - 7Mpa， 材料 溶血率小于 5%,透光率高于 90%,雾度低于 0. 1%,伸长率大于 1000。/。， 撕裂强度为 30 - 40kN/mo
人工玻璃体嚢袋的制作工艺， 包括：
( 1 )将眼模具浸入胶液中， 待其表面附胶后提起， 并重复前述 步骤 3 - ό次；
( 2 )将浸胶后的模具加热硫化成型；
( 3 )将已成型的球状外嚢从眼模具中剥离。
本发明嚢袋采用改性的聚硅氧烷弹性体，生物相容性高，弹性好。 动物实验植入人工玻璃体系統后， 经过电生理、 光镜和电镜检查， 证 实其容易植入和取出， 眼内无明显组织毒性反应。 制作工艺采用浸渍 成型的工艺方法， 有效地改善了嚢内表面的光滑度。
[具体实施方式]
本发明人工玻璃体系统由一个相当于玻璃体腔体积的改性聚硅 氧烷薄膜嚢袋、 引流管和引流阀组成。通过引流阔将嚢袋里充满生理 盐水，调节顶压视网膜的嚢袋的压力到合适水平，压力大也可以抽水， 压力小也可以再补充水。
人工玻璃体嚢袋主要以聚硅氧烷为材料制作而成，嚢袋壁厚度小 于 50 μ ιη,人工玻璃体的基本材料邵氏硬度为 30-40度，拉伸强度 4-7 pa , 伸长率大于 1000 %， 撕裂强度为 30- 40 kN / m， 材料溶血率小 于 5 % , 透光率高于 90 % , 雾度低于 0. 1 %。 聚硅氧烷弹性体是一种 透明性高分子聚合物， 形成硫化交联时没有低分子物质的产生与逸 出， 生物相容性、 成形工艺性和弹性均较好。 在生物学评价实验中均 呈阴性反应， 材料无明显毒性， 材料中不存在潜在致敏性物质， 所含 热原含量符合生物体的要求，是比较理想的人工玻璃体候选材料。 制 成的人工玻璃体可以通过引流阀注入水， 充填嚢袋， 同时可以调节嚢 袋压力。
上述人工玻璃体嚢袋的制作工艺： 应用人眼的专门模具，模具表 面及拐角应尽量光滑， 以利于成嚢内表面的光滑程度； 将模具緩慢浸 入胶液中， 待其表面附胶后提起， 重复浸胶提胶 3- 6次， 动作力度及 速度应适中， 防止出现气泡； 然后置烘箱加热硫化成型， 剥离即成所 要的球状外嚢。
所述的胶液是聚硅氧烷胶液。 硫化条件： 温度 80- 120°C , 时间 0. 5-4小时。
动物实验植入人工玻璃体系统后，经过电生理、光镜和电镜检查， 证实其容易植入和取出、 眼内无明显组织毒性反应。
由于有嚢袋限制， 本人工玻璃体不与眼组织广泛接触，从而避免 了现有玻璃体替代物对眼前节的影响；个别有严重眼内反应的患者不 能耐受， 也可以轻易地取出本人工玻璃体， 避免了现有玻璃体替代物 因取出困难而残留眼内。
由于均勾扩充，嚢袋可以对任何部位的视网膜裂孔均有持久的顶 压作用， 减少了视网膜脱离的复发机会， 提高了手术治愈率， 患者因 不需要反复多次的手术， 大大减轻了经济负担。

Claims

权利要求书
1、 一种人工玻璃体囊袋， 它主要以聚硅氧垸为材料制作而成。
2、 根据权利要求 1所述的人工玻璃体囊袋， 其特征在于囊袋壁 厚度小于 50 μ m，囊袋的邵氏硬度为 30— 40度，拉伸强度为 4一 7Mpa， 材料溶血率小于 5%， 透光率高于 90%， 雾度低于 0. 1%。
3、 根据权利要求 2所述的人工玻璃体囊袋， 其特征在于囊袋的 伸长率大于 1000%， 撕裂强度为 30— 40kN/m。
4、 一种如权利要求 1所述人工玻璃体囊袋的制作工艺， 包括：
( 1 ) 将眼模具浸入胶液中， 待其表面附胶后提起， 并重复前述 步骤 3— 6次；
( 2 ) 将浸胶后的模具加热硫化成型；
( 3 ) 将已成型的球状外囊从眼模具中剥离。
5、 根据权利要求 4所述人工玻璃体囊袋的制作工艺， 其特征在 于所述的胶液是聚硅氧垸胶液。
6、 根据权利要求 4或 5所述人工玻璃体囊袋的制作工艺， 其特 征在于硫化的条件为温度 80— 120°C， 时间 0. 5-4小时。
Figure imgf000009_0001
PCT/CN2006/000311 2006-01-24 2006-03-02 Sac capsulaire de corps vitré artificiel et procédé pour le produire WO2007085131A1 (fr)

Applications Claiming Priority (2)

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CN200610033296.2 2006-01-24
CN2006100332962A CN1810301B (zh) 2006-01-24 2006-01-24 人工玻璃体囊袋及其制作工艺

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