WO2019169835A1 - 一种泪小管栓 - Google Patents

一种泪小管栓 Download PDF

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Publication number
WO2019169835A1
WO2019169835A1 PCT/CN2018/101886 CN2018101886W WO2019169835A1 WO 2019169835 A1 WO2019169835 A1 WO 2019169835A1 CN 2018101886 W CN2018101886 W CN 2018101886W WO 2019169835 A1 WO2019169835 A1 WO 2019169835A1
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WO
WIPO (PCT)
Prior art keywords
punctum plug
initiator
catalyst
hydroxyethyl methacrylate
parts
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PCT/CN2018/101886
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English (en)
French (fr)
Inventor
李锐聪
杨习锋
曾晨光
郭少成
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广州新诚生物科技有限公司
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Publication of WO2019169835A1 publication Critical patent/WO2019169835A1/zh

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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
    • 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
    • A61F9/0008—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
    • 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
    • A61L24/001—Use of materials characterised by their function or physical properties
    • 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
    • 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
    • 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
    • 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
    • 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
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/145—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
    • 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
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/146—Porous materials, e.g. foams or sponges
    • 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
    • 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
    • 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/36—Materials or treatment for tissue regeneration for embolization or occlusion, e.g. vaso-occlusive compositions or devices

Definitions

  • the present application relates to the field of medical supplies, and in particular to a punctum plug.
  • Dry eye also known as keratoconjunctivitis, refers to a type of disease that causes symptoms of ocular discomfort due to abnormalities in tear fluid and volume or tear fluid instability and ocular surface damage.
  • emboli for thromboembolism is a relatively new technique for lacrimal passage closure. By mechanically blocking the lacrimal passage, the discharge of tears is reduced, the balance of ocular surface tears is reestablished, and the ocular surface environment is improved, thereby significantly reducing the patient's condition. Symptoms and signs of dry eye.
  • the tear tube plug is divided into temporary (degradable) and permanent.
  • Temporary lacrimal duct plugs are usually made of collagen material.
  • the collagen-like tear embolism acts as a temporary embolism and will eventually dissolve. The main function is to understand whether these emboli can play the role of preserving tears. The degree of tolerance of the patient.
  • the most commonly used material for permanent embolization is silicone material.
  • silicone material After embolization of the material, it is easy to cause foreign body sensation at the patient's implantation site. Moreover, such embolization is inferior in fixation, and the size of the embolization needs to be larger than the size of the implantation site at the time of implantation, and the tear tube expansion treatment is usually required in advance, and assisted by lubricating oil. This process often produces secondary damage, leading to bleeding, inflammation and other reactions, and then various complications such as granulation. At the same time, since the existing materials do not have a self-fixing function, they are easy to fall off.
  • the object of the present application includes providing a canaliculus tube which has good compliance after being implanted into the body, reduces the foreign body sensation at the implantation site, and has a good self-fixing effect, and is suitable for long-term. Implanted.
  • a tear tube plug is a solid cylinder; the length of the tear tube plug is 4 ⁇ 0.5 mm-8 ⁇ 0.5 mm; the diameter of the tear tube plug is 0.2 ⁇ 0.05 mm-2 ⁇ 0.05 mm.
  • the length of the punctum plug is 4 mm-8 mm; the diameter of the punctum plug is 0.2 mm-2 mm.
  • the joint between the end surface of the punctum plug and the circumferential side has a rounded chamfer.
  • the preparation raw material of the punctum plug includes hydroxyethyl methacrylate.
  • the punctum plug is made of hydroxyethyl methacrylate.
  • the punctum plug contains the following parts by weight of the preparation material:
  • the punctum plug contains the following parts by weight of the preparation material:
  • the initiator accounts for 0.1-10% of the sum of the masses of hydroxyethyl methacrylate, water and a crosslinking agent.
  • the initiator accounts for 1-8% of the sum of the masses of hydroxyethyl methacrylate, water and a crosslinking agent.
  • the catalyst accounts for 0.1 to 10% of the sum of the masses of hydroxyethyl methacrylate, water and a crosslinking agent.
  • the catalyst accounts for 1-8% of the sum of the masses of hydroxyethyl methacrylate, water and a crosslinking agent.
  • the initiator is a thermal initiator.
  • the thermal initiator is one or more of azobisisobutyronitrile, benzoyl peroxide and ammonium persulfate.
  • the catalyst is N,N,N',N'-tetramethylethylenediamine.
  • the punctum plug is a porous structure.
  • the tear tube plug of the embodiment of the present application is a solid cylinder; the length of the tear tube plug is 4 ⁇ 0.5 mm-8 ⁇ 0.5 mm; the diameter of the tear tube plug is 0.2 ⁇ 0.05 mm-2 ⁇ 0.05 mm. It has good compliance after implantation into the body, which reduces the foreign body sensation at the implantation site; it has a good self-fixation effect and is suitable for long-term implantation.
  • FIG. 1 is a schematic structural view of a punctum plug in an embodiment of the present application.
  • FIG. 2 is a schematic view showing the structure of a punctum plug in another embodiment of the present application.
  • Icon 1-Tear tubule plug; 2-round chamfer.
  • the existing punctum plugs are classified into temporary (degradable) and permanent.
  • Temporary lacrimal duct plugs are usually made of collagen material.
  • the collagen tears embolism acts as a temporary embolism and will eventually dissolve.
  • the main function is to understand whether the plug can play the role of preserving tears and patients. The degree of tolerance.
  • the most commonly used material for permanent tear tube plug is silicone material.
  • silicone material is a hydrophobic material and the mechanical strength is greatly different from that of the human tissue, it is likely to cause a foreign body sensation at the implantation site of the patient after implantation, and the biocompatibility is poor.
  • the silicone material does not have a self-expanding function.
  • the size of the material is larger than the size of the implant site.
  • the tear tube expansion treatment is required in advance, and the lubricant is assisted. This process often causes secondary damage, resulting in bleeding, inflammation, etc. The reaction, in turn, causes various complications such as granulation.
  • the material does not have a self-fixing function, it is easy to fall off.
  • the pHEMA hydrogel material is a hydrophilic material with good biocompatibility and mechanical strength comparable to that of human tissue.
  • the implantability is good after implantation, which greatly reduces the foreign body sensation at the implant site.
  • the hydrogel can absorb water and self-expand, has a good self-fixing effect, and is suitable for long-term implantation.
  • FIG. 1 is a schematic structural view of a punctum plug 1 according to an embodiment of the present application.
  • the punctum plug of the embodiment of the present application is a solid cylinder; the length of the punctum plug 1 is 4 ⁇ 0.5 mm-8 ⁇ 0.5 mm; the diameter of the punctum plug 1 is 0.2 ⁇ 0.05 mm-2 ⁇ 0.05 mm.
  • the preparation raw material of the punctum plug 1 of the embodiment of the present application includes hydroxyethyl methacrylate.
  • the length and diameter of the punctum plug 1 should be selected according to the actual use.
  • 2 is a schematic structural view of a punctum plug in another embodiment of the present application. In other embodiments of the present application, the connection between the end surface of the punctum plug 1 and the lateral peripheral surface may have a rounded chamfer 2 to alleviate User discomfort.
  • the punctum plug 1 can include hydroxyethyl methacrylate, water, a crosslinking agent, an initiator, and a catalyst.
  • the punctum plug 1 may include 1-80 parts of hydroxyethyl methacrylate, 10-80 parts of water, 1-20 parts of a crosslinking agent, an initiator and a catalyst;
  • the initiator accounts for 0.1-10% of the sum of the masses of hydroxyethyl methacrylate, water and a crosslinking agent
  • the catalyst accounts for hydroxyethyl methacrylate, water and a crosslinking agent. 0.1-10% of the sum of the masses.
  • the initiator is a thermal initiator.
  • the thermal initiator may be selected from one or more of azobisisobutyronitrile, benzoyl peroxide, and ammonium persulfate.
  • the punctum plug 1 has a porous structure, and thus facilitates drug adsorption.
  • the ratio of the weight of the initiator to the catalyst may be 1:1 to 3.
  • the catalyst may be selected from N, N, N', N'-tetramethylethylenediamine.
  • the punctum plug provided in this embodiment is prepared by using hydroxyethyl methacrylate (HEMA) as a substrate, and has the following advantages: it has the same mechanical strength as human tissue, and has good compliance after being implanted into the body, and is greatly reduced.
  • HEMA hydroxyethyl methacrylate
  • This embodiment provides a punctum plug having a length of 3.5 mm and a diameter of 0.15 mm.
  • the punctum plug of this embodiment is made of hydroxyethyl methacrylate.
  • This embodiment provides a punctum plug having a length of 4 mm and a diameter of 0.2 mm.
  • the punctum plug of the present embodiment comprises, by weight, 10 parts of hydroxyethyl methacrylate, 10 parts of water, 1 part of a crosslinking agent, and an initiator and a catalyst.
  • the catalyst comprises 0.1% by weight of the sum of the weights of hydroxyethyl methacrylate, water and a crosslinking agent, and the ratio of the weight of the initiator to the catalyst is 1:1.
  • This embodiment provides a punctum plug having a length of 4.5 mm and a diameter of 0.25 mm.
  • the punctum plug of the present embodiment comprises, by weight, 40 parts of hydroxyethyl methacrylate, 20 parts of water, 5 parts of a crosslinking agent, and an initiator and a catalyst.
  • the catalyst accounts for 3% of the sum of the weights of hydroxyethyl methacrylate, water and a crosslinking agent, and the ratio of the weight of the initiator to the catalyst is 1:1.5.
  • This embodiment provides a punctum plug having a length of 4.5 mm and a diameter of 0.25 mm.
  • the punctum plug of the present embodiment comprises, by weight, 20 parts of hydroxyethyl methacrylate, 40 parts of water, 5 parts of a crosslinking agent, and an initiator and a catalyst.
  • the catalyst accounts for 3% of the sum of the weights of hydroxyethyl methacrylate, water and a crosslinking agent, and the ratio of the weight of the initiator to the catalyst is 1:1.5.
  • This embodiment provides a punctum plug with a length of 6 mm and a diameter of 1 mm.
  • the punctum plug of the present embodiment comprises, by weight, 80 parts of hydroxyethyl methacrylate, 20 parts of water, 10 parts of a crosslinking agent, and an initiator and a catalyst.
  • the catalyst comprises 5% by weight of the sum of the weight of hydroxyethyl methacrylate, water and a crosslinking agent, and the ratio of the weight of the initiator to the catalyst is 1:2.
  • This embodiment provides a punctum plug having a length of 8 mm and a diameter of 1.5 mm.
  • the punctum plug of the present embodiment comprises, by weight, 80 parts of hydroxyethyl methacrylate, 60 parts of water, 10 parts of a crosslinking agent, and an initiator and a catalyst.
  • the catalyst accounts for 8% of the sum of the weights of hydroxyethyl methacrylate, water and a crosslinking agent, and the ratio of the weight of the initiator to the catalyst is 1:2.
  • the junction of the end face of the punctum plug and the circumferential side has a rounded chamfer.
  • This embodiment provides a punctum plug having a length of 8.5 mm and a diameter of 1.95 mm.
  • the punctum plug of the present embodiment comprises, by weight, 70 parts of hydroxyethyl methacrylate, 80 parts of water, 10 parts of a crosslinking agent, and an initiator and a catalyst.
  • the catalyst accounts for 10% of the sum of the weights of hydroxyethyl methacrylate, water and a crosslinking agent, and the ratio of the weight of the initiator to the catalyst is 1:2.
  • the junction of the end face of the punctum plug and the circumferential side has a rounded chamfer.
  • This embodiment provides a punctum plug having a length of 8 mm and a diameter of 2 mm.
  • the punctum plug of the present embodiment comprises, by weight, 70 parts of hydroxyethyl methacrylate, 80 parts of water, 10 parts of a crosslinking agent, and an initiator and a catalyst.
  • the catalyst accounts for 8% by weight of the hydroxyethyl methacrylate, water and the crosslinking agent, and the ratio of the weight of the initiator to the catalyst is 1:3.
  • This embodiment provides a punctum plug having a length of 8.5 mm and a diameter of 2.05 mm.
  • the punctum plug of the present embodiment comprises, by weight, 80 parts of hydroxyethyl methacrylate, 80 parts of water, 20 parts of a crosslinking agent, and an initiator and a catalyst.
  • the catalyst accounts for 10% of the sum of the weights of hydroxyethyl methacrylate, water and a crosslinking agent, and the ratio of the weight of the initiator to the catalyst is 1:1.
  • the junction of the end face of the punctum plug and the circumferential side has a rounded chamfer.
  • the punctum plug disclosed in the present application has good compliance after being implanted into the body, and greatly reduces the foreign body sensation at the implantation site; and it has a good self-fixation effect and is suitable for long-term implantation.

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  • Life Sciences & Earth Sciences (AREA)
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  • Heart & Thoracic Surgery (AREA)
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Abstract

一种泪小管栓（1）为实心圆柱体，长度为4±0.5mm-8±0.5mm，直径为0.2±0.05mm-2±0.05mm，其制备原料包括甲基丙烯酸羟乙酯。泪小管栓（1）植入体内后顺应性良好，降低了植入部位的异物感，而且其具有很好的自固定效果，适合长期植入。

Description

一种泪小管栓
相关申请的交叉引用
本申请要求于2018年03月08日提交中国专利局的申请号为201810193380.3、名称为“一种泪小管栓”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗用品领域，具体涉及一种泪小管栓。
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。
泪小管栓分为临时性(可降解性)和永久性两种。临时性泪小管栓通常采用胶原蛋白材料制成，胶原性泪小点栓子起到临时性栓塞作用，最终会溶解，主要作用通过它可以了解这类栓子能否起到保存泪液的作用以及患者的耐受程度。
永久性栓塞最为常用的材料为硅胶材料，然而该材料的栓塞植入后容易引起病人植入部位异物感。而且该类栓塞固定性较差，植入时该类栓塞大小需要比植入部位尺寸大，通常需预先进行泪小管扩张处理，同时以润滑油辅助。该过程常产生二次损伤，导致出血、炎症等反应，进而发生肉芽增生等各类并发症。同时由于现有的材料不具备自固定功能，易于脱落。
发明内容
针对现有技术的缺点，本申请的目的包括提供一种泪小管，该泪小管栓植入体内后顺应性良好，降低了植入部位的异物感；而且具有很好的自固定效果，适合长期植入。
本申请实施例通过以下方式实现：
一种泪小管栓，泪小管栓为实心圆柱体；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。
进一步的，泪小管栓的长度为4mm-8mm；泪小管栓的直径为0.2mm-2mm。
进一步的，泪小管栓的端面与周侧面的连接处具有圆倒角。
进一步的，泪小管栓的制备原料包括甲基丙烯酸羟基乙酯。
在本申请的一种实施例中，泪小管栓由甲基丙烯酸羟基乙酯制成。
在本申请的一种实施例中，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。
进一步的，泪小管栓包含以下重量份的制备原料：
甲基丙烯酸羟乙酯20-60份、水20-60份、交联剂5-15份、引发剂和催化剂。
进一步的，引发剂占甲基丙烯酸羟乙酯、水及交联剂的质量之和的0.1-10％。
进一步的，引发剂占甲基丙烯酸羟乙酯、水及交联剂的质量之和的1-8％。
进一步的，催化剂占甲基丙烯酸羟乙酯、水及交联剂的质量之和的0.1-10％。
进一步的，催化剂占甲基丙烯酸羟乙酯、水及交联剂的质量之和的1-8％。
进一步的，引发剂和催化剂的重量之比为：引发剂：催化剂＝1:1～3。
进一步的，引发剂和催化剂的重量之比为：引发剂：催化剂＝1:1～2。
可选的，引发剂为热引发剂。
可选的，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。
可选的，催化剂为N,N,N',N'-四甲基乙二胺。
可选的，泪小管栓为多孔结构。
本申请实施例的有益效果是：
本申请实施例提供的泪小管栓，泪小管栓为实心圆柱体；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。其植入体内后顺应性良好，降低了植入部位的异物感；具有很好的自固定效果，适合长期植入。
附图说明
为了更清楚地说明本申请实施例的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，应当理解，以下附图仅示出了本申请的某些实施例，因此不应被看作是对范围的限定，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他相关的附图。
图1为本申请的一种实施例中泪小管栓的结构示意图；
图2为本申请的另一实施例中泪小管栓的结构示意图。
图标：1-泪小管栓；2-圆倒角。
具体实施方式
为使本申请实施例的目的、技术方案和优点更加清楚，下面将对本申请实施例中的技 术方案进行清楚、完整地描述。实施例中未注明具体条件者，按照常规条件或制造商建议的条件进行。所用试剂或仪器未注明生产厂商者，均为可以通过市售购买获得的常规产品。
现有的泪小管栓分为临时性(可降解性)和永久性两种。临时性泪小管栓通常采用胶原蛋白材料制成，胶原性泪小点栓子起到临时性栓塞作用，最终会溶解，主要作用通过它可以了解这类栓体能否起到保存泪液的作用以及患者的耐受程度。
目前，永久性泪小管栓最为常用材料为硅胶材料。发明人发现，由于该材料为疏水性材料，同时力学强度与人体组织相差较大，植入后容易引起病人植入部位异物感，生物相容性不佳。而且硅胶材料不具备自膨胀功能，植入时该材料大小比植入部位尺寸大，通常需预先进行泪小管扩张处理，同时以润滑油辅助，该过程常产生二次损伤，导致出血、炎症等反应，进而发生肉芽增生等各类并发症。同时由于该材料不具备自固定功能，易于脱落。
发明人在研究过程中发现，pHEMA水凝胶材料属于亲水性材料，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。
参见图1，图1为本申请的一种实施例中泪小管栓1的结构示意图。本申请实施例提供的泪小管栓为实心圆柱体；泪小管栓1的长度为4±0.5mm-8±0.5mm；泪小管栓1的直径为0.2±0.05mm-2±0.05mm。本申请实施例的泪小管栓1的制备原料包括甲基丙烯酸羟基乙酯。泪小管栓1的长度、直径应当根据实际使用情况进行选择。图2为本申请的另一实施例中泪小管栓的结构示意图，在本申请的另一些实施例中，泪小管栓1的端面与侧周面的连接处可以具有圆倒角2，以缓解使用者的不适感。
可选的，本申请实施例的泪小管栓1由甲基丙烯酸羟基乙酯制成。
在本申请的另一些是实施例中，泪小管栓1可以包括甲基丙烯酸羟乙酯、水、交联剂、引发剂和催化剂。
进一步的，按重量份计，泪小管栓1可以包括甲基丙烯酸羟乙酯1-80份、水10-80份、交联剂1-20份、引发剂和催化剂；
其中，可选的，所述引发剂占甲基丙烯酸羟乙酯、水以及交联剂的质量之和的0.1-10％，所述催化剂占甲基丙烯酸羟乙酯、水及交联剂的质量之和的0.1-10％。
进一步的，引发剂为热引发剂。热引发剂可选为偶氮二异丁腈、过氧化苯甲酰和过硫酸铵中的一种或多种。
进一步的，泪小管栓1具有多孔结构，因此便于吸附药物。
在本申请实施例中，所述引发剂和催化剂的重量之比可选为1:1～3。其中，催化剂可选用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。
以下结合具体实施例来对本申请的方案进行进一步阐述。
实施例1
本实施例提供一种泪小管栓，其长度为3.5mm，直径为0.15mm。本实施例的泪小管栓由甲基丙烯酸羟基乙酯制成。
实施例2
本实施例提供一种泪小管栓，其长度为4mm，直径为0.2mm。本实施例的泪小管栓按重量份计包括：10份甲基丙烯酸羟乙酯、10份水、1份交联剂，以及引发剂和催化剂。其中，催化剂占甲基丙烯酸羟乙酯、水及交联剂的重量之和的0.1％，引发剂与催化剂的重量之比为1:1。
实施例3
本实施例提供一种泪小管栓，其长度为4.5mm，直径为0.25mm。本实施例的泪小管栓按重量份计包括：40份甲基丙烯酸羟乙酯、20份水、5份交联剂，以及引发剂和催化剂。其中，催化剂占甲基丙烯酸羟乙酯、水及交联剂的重量之和的3％，引发剂与催化剂的重量之比为1:1.5。
实施例4
本实施例提供一种泪小管栓，其长度为4.5mm，直径为0.25mm。本实施例的泪小管栓按重量份计包括：20份甲基丙烯酸羟乙酯、40份水、5份交联剂，以及引发剂和催化剂。其中，催化剂占甲基丙烯酸羟乙酯、水及交联剂的重量之和的3％，引发剂与催化剂的重量之比为1:1.5。
实施例5
本实施例提供一种泪小管栓，其长度为6mm，直径为1mm。本实施例的泪小管栓按重量份计包括：80份甲基丙烯酸羟乙酯、20份水、10份交联剂，以及引发剂和催化剂。其中，催化剂占甲基丙烯酸羟乙酯、水及交联剂的重量之和的5％，引发剂与催化剂的重量之比为1:2。
实施例6
本实施例提供一种泪小管栓，其长度为8mm，直径为1.5mm。本实施例的泪小管栓按重量份计包括：80份甲基丙烯酸羟乙酯、60份水、10份交联剂，以及引发剂和催化剂。其中，催化剂占甲基丙烯酸羟乙酯、水及交联剂的重量之和的8％，引发剂与催化剂的重量之比为1:2。泪小管栓的端面与周侧面的连接处具有圆倒角。
实施例7
本实施例提供一种泪小管栓，其长度为8.5mm，直径为1.95mm。本实施例的泪小管栓按重量份计包括：70份甲基丙烯酸羟乙酯、80份水、10份交联剂，以及引发剂和催化剂。其中，催化剂占甲基丙烯酸羟乙酯、水及交联剂的重量之和的10％，引发剂与催化剂的重量之比为1:2。泪小管栓的端面与周侧面的连接处具有圆倒角。
实施例8
本实施例提供一种泪小管栓，其长度为8mm，直径为2mm。本实施例的泪小管栓按重量份计包括：70份甲基丙烯酸羟乙酯、80份水、10份交联剂，以及引发剂和催化剂。其中，催化剂占甲基丙烯酸羟乙酯、水及交联剂的重量之和的8％，引发剂与催化剂的重量之比为1:3。
实施例9
本实施例提供一种泪小管栓，其长度为8.5mm，直径为2.05mm。本实施例的泪小管栓按重量份计包括：80份甲基丙烯酸羟乙酯、80份水、20份交联剂，以及引发剂和催化剂。其中，催化剂占甲基丙烯酸羟乙酯、水及交联剂的重量之和的10％，引发剂与催化剂的重量之比为1:1。泪小管栓的端面与周侧面的连接处具有圆倒角。
虽然本申请的部分实施例揭露如上，但并非用以限定本申请实施的范围。任何本领域的普通技术人员，在不脱离本申请范围内，当可作些许的改进，即凡是依照本申请所做的同等改进，应为本申请的范围所涵盖。
工业实用性
本申请公开的泪小管栓，其植入体内后顺应性良好，大大降低了植入部位的异物感；而且其具有很好的自固定效果，适合长期植入。

Claims (17)

  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，所述泪小管栓的长度为4mm-8mm；所述泪小管栓的直径为0.2mm-2mm。
  3. 如权利要求1所述的泪小管栓，其特征在于，所述泪小管栓的端面与周侧面的连接处具有圆倒角。
  4. 如权利要求1所述的泪小管栓，其特征在于，所述泪小管栓的制备原料包括甲基丙烯酸羟基乙酯。
  5. 如权利要求4所述的泪小管栓，其特征在于，所述泪小管栓由甲基丙烯酸羟基乙酯制成。
  6. 如权利要求4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。
  7. 如权利要求6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20-60份、水20-60份、交联剂5-15份、引发剂和催化剂。
  8. 如权利要求6所述的泪小管栓，其特征在于，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之和的0.1-10％。
  9. 如权利要求8所述的泪小管栓，其特征在于，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之和的1-8％。
  10. 如权利要求6所述的泪小管栓，其特征在于，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质量之和的0.1-10％。
  11. 如权利要求10所述的泪小管栓，其特征在于，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质量之和的1-8％。
  12. 如权利要求6-11中任一项所述的泪小管栓，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＝1:1～3。
  13. 如权利要求12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＝1:1～2。
  14. 如权利要求6-13中任一项所述的泪小管栓，其特征在于，所述引发剂为热引发剂。
  15. 如权利要求14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。
  16. 如权利要求6-13中任一项所述的泪小管栓，其特征在于，所述催化剂为N,N,N',N'-四甲基乙二胺。
  17. 如权利要求1-16中任一项所述的泪小管栓，其特征在于，所述泪小管栓为多孔结构。
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