CN108652825A - 一种泪小管栓 - Google Patents

一种泪小管栓 Download PDF

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Publication number
CN108652825A
CN108652825A CN201810193380.3A CN201810193380A CN108652825A CN 108652825 A CN108652825 A CN 108652825A CN 201810193380 A CN201810193380 A CN 201810193380A CN 108652825 A CN108652825 A CN 108652825A
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hydroxyethyl methacrylate
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lacrimal bolt
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李锐聪
杨习锋
曾晨光
郭少成
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Guangzhou Sun Shing Biotech Co ltd
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    • 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
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    • A—HUMAN NECESSITIES
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    • 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
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
    • A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
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    • A61L24/0031—Hydrogels or hydrocolloids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L24/00—Surgical adhesives or cements; Adhesives for colostomy devices
    • A61L24/04—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials
    • A61L24/06—Surgical adhesives or cements; Adhesives for colostomy devices containing macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/048—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
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    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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    • A61L31/145—Hydrogels or hydrocolloids
    • A—HUMAN NECESSITIES
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    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/16—Materials or treatment for tissue regeneration for reconstruction of eye parts, e.g. intraocular lens, cornea
    • A—HUMAN NECESSITIES
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    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
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Abstract

本发明公开了一种泪小管栓，该泪小管栓为由甲基丙烯酸羟基乙酯制成的实心圆柱体；泪小管栓的长度为4±0.5mm－8±0.5mm；泪小管栓的直径为0.2±0.05mm－2±0.05mm。其包含以下重量份的制备原料：甲基丙烯酸羟乙酯10－80份、水10－80份、交联剂1－20份、引发剂和催化剂；甲基丙烯酸羟乙酯、水及交联剂的质量份数之和为100份；引发剂占甲基丙烯酸羟乙酯、水及交联剂的质量的质量的0.1－10％，催化剂占甲基丙烯酸羟乙酯、水及交联剂的0.1－10％。本发明公开的泪小管栓，其与人体组织力学强度相当，植入体内后顺应性良好，大大降低了植入部位的异物感；而且其能够吸水自膨胀，具有很好的自固定效果，适合长期植入。

Description

一种泪小管栓
技术领域
本发明涉及一种泪小管栓。
背景技术
干眼，又称角膜结膜干燥症，是指由于泪液质和量的异常或泪液流体动力学异常引起的泪膜不稳定和眼表损害，从而导致眼部不适症状的一类疾病。使用各种栓子进行泪小管栓塞是一种较新的泪道封闭技术，通过机械性阻塞泪道，减少了泪液的排出，重新建立眼表泪液的平衡，改善眼表环境，从而明显减轻患者干眼的症状和体征。
目前，最为常用的栓塞材料为硅橡胶或聚氨酯，然而二者力学强度与人体组织相差较大，同时缺少生物活性，植入后容易引起病人植入部位异物感；而且材料呈疏水性，植入时需以润滑油辅助，且植入周期一般不超过一个月，因此逾期需要更换，进行二次手术取出，常产生二次损伤，导致出血、炎症等反应，进而发生肉芽增生等现象，不适合作为植入物植入体内。
申请人在研究过程中发现，pHEMA水凝胶材料生物相容性好，与人体组织力学强度相当，植入体内后顺应性良好，大大降低了植入部位的异物感；而且该水凝胶能够吸水自膨胀，具有很好的自固定效果，适合长期植入。
因此，提出一种由pHEMA水凝胶材料制成的泪小管栓显得尤为重要。
发明内容
针对现有技术的缺点，本发明的目的是提供一种泪小管，该泪小管栓采用 pHEMA水凝胶材料制成，其与人体组织力学强度相当，植入体内后顺应性良好，大大降低了植入部位的异物感；而且其能够吸水自膨胀，具有很好的自固定效果，适合长期植入。
为实现上述目的，本发明提供了一种泪小管栓，所述泪小管栓为实心圆柱体；所述泪小管栓的长度为4±0.5mm-8±0.5mm；所述泪小管栓的直径为0.2± 0.05mm-2±0.05mm。
与现有技术相比，本发明公开的泪小管栓，采用甲基丙烯酸羟基乙酯(HEMA) 作为基材，制备而成，其具有以下优点：其与人体组织力学强度相当，植入体内后顺应性良好，大大降低了植入部位的异物感；而且其能够吸水自膨胀，具有很好的自固定效果，适合长期植入。
根据本发明另一具体实施方式，所述泪小管栓为由甲基丙烯酸羟基乙酯制成的实心圆柱体。
根据本发明另一具体实施方式，所述泪小管栓包含以下重量份的制备原料：
甲基丙烯酸羟乙酯10-80份、水10-80份、交联剂1-20份、引发剂和催化剂；
所述甲基丙烯酸羟乙酯、所述水及所述交联剂的质量份数之和为100份；所述引发剂占所述甲基丙烯酸羟乙酯、所述水及所述交联剂的质量的质量的 0.1-10％，所述催化剂占所述甲基丙烯酸羟乙酯、所述水及所述交联剂的 0.1-10％。
根据本发明另一具体实施方式，所述引发剂为热引发剂。
根据本发明另一具体实施方式，所述热引发剂为偶氮二异丁腈、过氧化苯甲酰和过硫酸铵中的一种或多种。
根据本发明另一具体实施方式，所述引发剂和催化剂的重量之比为：引发剂：催化剂＝1:2。
根据本发明另一具体实施方式，所述催化剂为N,N,N',N'-四甲基乙二胺。
下面将对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
具体实施方式
实施例1
本实施例提供了一种泪小管栓，其为由甲基丙烯酸羟基乙酯制成的实心圆柱体；泪小管栓的长度为4±0.5mm-8±0.5mm；泪小管栓的直径为0.2±0.05mm-2 ±0.05mm。
该泪小管栓包含以下重量份的制备原料：
甲基丙烯酸羟乙酯10-80份、水10-80份、交联剂1-20份、引发剂和催化剂；
所述甲基丙烯酸羟乙酯、所述水及所述交联剂的质量份数之和为100份；所述引发剂占所述甲基丙烯酸羟乙酯、所述水及所述交联剂的质量的质量的0.1-10％，所述催化剂占所述甲基丙烯酸羟乙酯、所述水及所述交联剂的 0.1-10％。
本实施例中，引发剂为热引发剂。
本实施例中，所述热引发剂为偶氮二异丁腈、过氧化苯甲酰和过硫酸铵中的一种或多种。
本实施例中，所述引发剂和催化剂的重量之比为：引发剂：催化剂＝1:2。
本实施例中，所述催化剂为N,N,N',N'-四甲基乙二胺。
本实施例提供的泪小管栓，采用甲基丙烯酸羟基乙酯(HEMA)作为基材，制备而成，其具有以下优点：其与人体组织力学强度相当，植入体内后顺应性良好，大大降低了植入部位的异物感；而且其能够吸水自膨胀，具有很好的自固定效果，适合长期植入。
虽然本发明以较佳实施例揭露如上，但并非用以限定本发明实施的范围。任何本领域的普通技术人员，在不脱离本发明的发明范围内，当可作些许的改进，即凡是依照本发明所做的同等改进，应为本发明的范围所涵盖。

Claims (7)

1.一种泪小管栓，其特征在于，所述泪小管栓为实心圆柱体；所述泪小管栓的长度为4±0.5mm－8±0.5mm；所述泪小管栓的直径为0.2±0.05mm－2±0.05mm。
2.如权利要求1所述的泪小管栓，其特征在于，所述泪小管栓为由甲基丙烯酸羟基乙酯制成的实心圆柱体。
3.如权利要求1所述的泪小管栓，其特征在于，所述泪小管栓包含以下重量份的制备原料：
甲基丙烯酸羟乙酯10－80份、水10－80份、交联剂1－20份、引发剂和催化剂；
所述甲基丙烯酸羟乙酯、所述水及所述交联剂的质量份数之和为100份；所述引发剂占所述甲基丙烯酸羟乙酯、所述水及所述交联剂的质量的质量的0.1－10％，所述催化剂占所述甲基丙烯酸羟乙酯、所述水及所述交联剂的0.1－10％。
4.如权利要求3所述的泪小管栓，其特征在于，所述引发剂为热引发剂。
5.如权利要求4所述的泪小管栓，其特征在于，所述热引发剂为偶氮二异丁腈、过氧化苯甲酰和过硫酸铵中的一种或多种。
6.如权利要求3所述的泪小管栓，其特征在于，所述引发剂和催化剂的重量之比为：引发剂：催化剂＝1:2。
7.如权利要求3所述的泪小管栓，其特征在于，所述催化剂为N,N,N',N'-四甲基乙二胺。
CN201810193380.3A 2018-03-08 2018-03-08 一种泪小管栓 Pending CN108652825A (zh)

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CN201810193380.3A CN108652825A (zh) 2018-03-08 2018-03-08 一种泪小管栓
PCT/CN2018/101886 WO2019169835A1 (zh) 2018-03-08 2018-08-23 一种泪小管栓

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110269742A (zh) * 2019-05-28 2019-09-24 广州新诚生物科技有限公司 一种空心水凝胶泪点塞的制备方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140025022A1 (en) * 2011-08-29 2014-01-23 Qlt Inc. Drug delivery system and methods of treating open angle glaucoma and ocular hypertension
CN204411086U (zh) * 2014-12-26 2015-06-24 易浦润（上海）生物技术有限公司 一种泪小管栓子
CN104984411A (zh) * 2015-07-17 2015-10-21 厦门浩益视生物科技有限公司 一种泪小管栓子及其制备方法
CN106667656A (zh) * 2016-06-30 2017-05-17 广州聚明生物科技有限公司 生物可降解泪道栓及其制备方法和应用
CN107698720A (zh) * 2017-10-30 2018-02-16 广州新诚生物科技有限公司 一种人工鼻泪管及其制备方法

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140025022A1 (en) * 2011-08-29 2014-01-23 Qlt Inc. Drug delivery system and methods of treating open angle glaucoma and ocular hypertension
CN204411086U (zh) * 2014-12-26 2015-06-24 易浦润（上海）生物技术有限公司 一种泪小管栓子
CN104984411A (zh) * 2015-07-17 2015-10-21 厦门浩益视生物科技有限公司 一种泪小管栓子及其制备方法
CN106667656A (zh) * 2016-06-30 2017-05-17 广州聚明生物科技有限公司 生物可降解泪道栓及其制备方法和应用
CN107698720A (zh) * 2017-10-30 2018-02-16 广州新诚生物科技有限公司 一种人工鼻泪管及其制备方法

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110269742A (zh) * 2019-05-28 2019-09-24 广州新诚生物科技有限公司 一种空心水凝胶泪点塞的制备方法

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