CN104398329A - Completely-degradable net-shaped nasolacrimal stent and implantation system thereof - Google Patents

Completely-degradable net-shaped nasolacrimal stent and implantation system thereof Download PDF

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CN104398329A
CN104398329A CN 201410521759 CN201410521759A CN104398329A CN 104398329 A CN104398329 A CN 104398329A CN 201410521759 CN201410521759 CN 201410521759 CN 201410521759 A CN201410521759 A CN 201410521759A CN 104398329 A CN104398329 A CN 104398329A
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net
stent
mesh
balloon
body portion
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CN 201410521759
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Chinese (zh)
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黄彬
谢建
李建军
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浦易(上海)生物技术有限公司
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Publication of CN104398329A publication Critical patent/CN104398329A/en

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Abstract

The invention relates to a completely-degradable net-shaped nasolacrimal stent. The completely-degradable net-shaped nasolacrimal stent comprises a sleeve-shaped net-shaped body made of biodegradable high polymer materials and provided with holes; a medicine coating is arranged on the surface of the net-shaped body; the net-shaped body is composed of a first net-shaped body part and a second net-shaped body part which are connected; in the compression state, the first net-shaped body part and the second net-shaped body part are the same in diameter; and in the expansion state, the diameter of the first net-shaped body part is larger than the diameter of the second net-shaped body part. After lumen rebuilding is completed, water and carbon dioxide are finally generated by the completely-degradable net-shaped nasolacrimal stent to be discharged through the nasal cavity; and second operations and pains of a patient are avoided. The nasolacrimal stent is suitable for approaching the body from the nasal cavity, so that injuries, caused by the fact that the nasolacrimal stent approaches the body from the positions above the eyes, to the lacrimal ductile and the nasolacrimal canal inner membrane are avoided. By means of the completely-degradable net-shaped nasolacrimal stent, the medicine slow release effect is achieved through the medicine coating; and continuous treatment on the nasolacrimal canal for a long time is accordingly achieved.

Description

—种可完全降解的网状的鼻泪管支架及其植入系统 - fully degradable kind of mesh stent and nasal lacrimal implant system

技术领域 FIELD

[0001] 本发明涉及用于眼部疾病的医疗器械,更具体地涉及一种可完全降解的网状的鼻泪管支架及其植入系统。 [0001] and more particularly, to a fully degradable mesh nasal lacrimal stent and implant system of the present invention relates to medical devices for eye diseases.

背景技术 Background technique

[0002] 鼻泪管阻塞和慢性泪囊炎是常见的眼部疾病,目前的治疗方法主要有泪道探通术和鼻腔泪囊吻合术。 [0002] nasolacrimal duct obstruction and chronic dacryocystitis eye diseases are common, current treatment methods and tears channel sounding dacryocystorhinostomy. 泪道探通术创伤小,操作简单,但是需要进行多次反复探通,增加病患的痛苦,而且复发率高,治疗效果差。 Lacrimal surgery less invasive, simple, but requires repeatedly probing, increase patient suffering, and recurrence rate, poor treatment. 泪囊鼻腔吻合术作为经典的手术方式,目的是把泪囊与鼻黏膜直接吻合,使分泌物和泪液由泪囊直接进入中鼻道,以消除泪囊化脓性病灶并解除泪溢现象。 Dacryocystorhinostomy as a classic surgical approach, which aims to lacrimal sac and nasal mucosa anastomosis, and tears by the lacrimal secretions directly into the nasal passages in order to eliminate the lacrimal purulent lesions and relieve epiphora phenomenon. 这种手术方法是治疗鼻泪管阻塞和慢性泪囊炎最有效的方法,但是操作相对复杂,而且要开刀,术中出血多,手术时间长,恢复周期长,术后面部会留有疤痕,且术后住院时间长,老年人和小孩不适宜进行该类手术。 This surgical method is the treatment of nasolacrimal duct obstruction and chronic dacryocystitis most effective way, but the operation is relatively complex, but also to surgery, blood loss and more surgery for a long time, a long recovery period, postoperative facial will leave scars, and the postoperative hospital stay for a long time, the elderly and children not suitable for such surgery.

[0003] 针对目前诊疗技术的不足,鼻泪管支架被用来治疗鼻泪管阻塞和慢性泪囊炎,它的主要优点是创伤小、手术时间短,恢复快等。 [0003] insufficient for the current treatment technology, nasal lacrimal stents are used to treat chronic nasolacrimal duct obstruction and dacryocystitis, its main advantage is trauma, shorter operation time, and quick recovery. 现有的鼻泪管支架为硅胶材料制成,这种支架植入后,短期内能恢复鼻泪管的畅通,但长久植入后,可能会产生很多由支架植入引起的炎症,从而再次阻塞鼻泪管通道。 Conventional nasal lacrimal stent is made of silicone material, which after stent implantation, the short term can restore flow nasolacrimal duct, but the long-term implant, may cause inflammation caused by many stent implantation, thereby again nasolacrimal duct obstruction channels. 且多数鼻泪管支架在植入1-3个月后需要取出,若骨性狭窄严重者可适当延长至一年时间。 And most nasolacrimal duct stent need to be removed after implantation of 1-3 months, if severe stenosis bone may be extended to one year. 植入一段时间后,支架会和鼻泪管内黏膜粘连在一起,这样鼻泪管支架就不能顺利取出,一方面会增加病人的痛苦,另一方面需要二次植入支架打开阻塞的鼻泪管。 A period of time after implantation, stent will nasolacrimal duct mucosa and to stick together, so nasolacrimal duct stent can not be removed successfully, on the one hand will increase the suffering of the patients, on the other hand the need for secondary stenting to open blocked nasolacrimal duct .

[0004] 同时,上述的现有的鼻泪管支架的植入一般是通过泪小管导丝牵引来实现:先使用泪道探通导引针探通泪道,泪小管导丝穿过泪道探通针针芯,直至伸出鼻腔,然后泪小管导丝牵引鼻泪管支架上引线,从眼上方向上拉导丝,直至把支架拉入鼻泪道。 [0004] Meanwhile, a conventional stent implanted in the nasolacrimal duct is generally accomplished by pulling the guidewire canalicular: Use lacrimal first guide pin probing lacrimal canaliculus guidewire through the lacrimal probing needle core, until the projecting nose and canalicular guidewire traction wire holder nasolacrimal duct, pulling the guidewire in a direction from the eye, until the stent pull nasolacrimal duct. 因为泪小管是细小和柔弱的结构,泪小管导丝的进入一方面会对泪小管造成损伤,另一方面对病人造成痛苦。 Because of canalicular it is small and weak structure, canalicular guidewire into the hand will canalicular damage, on the other hand cause pain to the patient. 这种鼻泪管支架的植入方法用力较大,由于鼻泪管支架较粗,会损伤鼻泪道内膜,造成二次伤害,给患者造成肉体上和精神上更大的痛苦。 This method of implantation nasolacrimal duct stent with greater force, due to the nasolacrimal duct stents thick, will damage the nasolacrimal duct lining, causing secondary damage, resulting in greater physical and psychological pain to the patient.

发明内容 SUMMARY

[0005] 为了解决上述现有技术存在的鼻泪管支架的植入容易损伤鼻泪道内膜,而鼻泪管支架的取出增加患者痛苦的问题,本发明旨在提供一种可完全降解的网状的鼻泪管支架及其植入系统。 [0005] In order to solve the stent implant nasolacrimal duct present in the prior art described above is easily damaged intima nasolacrimal duct, and the stent removed nasolacrimal duct increases in patients suffering problems, the present invention aims to provide a fully degradable nasal lacrimal mesh stent and implant system.

[0006] 本发明所述的可完全降解的网状的鼻泪管支架,包括由生物可降解高分子材料形成的套筒状的具有孔隙的网状本体,所述网状本体的表面上具有药物涂层;所述网状本体由彼此相连的第一网状本体部分和第二网状本体部分组成;在压缩状态下,所述第一网状本体部分和所述第二网状本体部分具有相同的直径;在扩张状态下,所述第一网状本体部分的直径大于所述第二网状本体部分的直径。 [0006] fully degradable mesh according to the present invention is a nasal lacrimal stent comprising a biodegradable polymer material forming the sleeve-like body having pores of a mesh, the mesh body having an upper surface drug coating; a first web by a body portion of the mesh body connected to each other and a second mesh body part; in a compressed state, the first body portion and the second web mesh body portion It has the same diameter; in an expanded state, the diameter of the first body portion is greater than the web diameter of the second body portion of the mesh.

[0007] 本发明的鼻泪管支架由生物可降解高分子材料形成,在管腔重建完成后,该鼻泪管支架逐渐降解,最后生成水和二氧化碳通过鼻腔排出。 [0007] The nasal lacrimal stent of the present invention consists of a biodegradable polymer material is formed in the lumen after completion of the reconstruction, the nasal lacrimal stent is gradually degraded and finally water and carbon dioxide is discharged through the nasal cavity. 该完全可降解的网状的鼻泪管支架避免了像现有硅胶鼻泪管支架那样的术后取出,避免了二次手术,减免了病患痛苦。 The mesh completely biodegradable stent of the nasolacrimal duct surgery that avoids extraction as in the conventional silicone nasolacrimal stent, to avoid a second surgery, the patient pain relief. 该可降解高分子材料可采用不同的聚合物或共聚物,或者采用不同的加工方式,如共混,中空或夹层等形式来调节降解速度,以适应不同病患的治疗周期不同的需求。 The biodegradable polymer material may employ different polymers or copolymers, or different processing methods, such as blending and the like, or a sandwich hollow degradation rate is adjusted to accommodate different patient needs different treatment cycles. 本发明的鼻泪管支架充分地考虑了管壁的贴合性而设计了变直径的网状本体部分,适合于从鼻腔入路,从而避免了现有的从眼上方入路对泪小管和鼻泪道内膜的损害,使鼻泪管支架的植入更方便和容易,将对病人的伤害降低到最小,而且该变直径的网状本体部分由于贴合鼻泪道而能够更好地引流泪液。 Nasal lacrimal stent of the present invention is considered fully fit wall is designed in the web of the variable diameter body portion, adapted to the path from the nasal cavity, thereby avoiding the conventional approach from the top of the eye and canaliculus nasolacrimal duct intima damage, the implant holder nasolacrimal duct is more convenient and easier, the patient will reduce the damage to a minimum, and the diameter of the web becomes bonded to the body portion due to the nasolacrimal duct and to better drainage of tears. 另外,由于现有的鼻泪管支架的植入方式的限制,现有的鼻泪管支架的表面上不包含药物,而本发明的鼻泪管支架通过支架来负载药物,可以有效对鼻泪道进行治疗,而且可以根据需要实现缓释。 Further, due to limitations of conventional implantation in nasolacrimal duct stents, on the existing surface does not include nasal lacrimal stents drugs, nasal lacrimal stent of the present invention to load the drug via a bracket to be effective for nasolacrimal Road treatment, and sustained release may be achieved as necessary.

[0008] 该生物可降解高分子材料选自以下材料中的一种或几种:可降解聚胺酯,可降解聚酯,自聚(L-丙交酯-共-D-丙交酯)、聚(L-丙交酯-共-D,L-丙交酯)、聚(D-丙交酯-共-D,L_丙交酯)、聚(丙交酯-共-乙交酯)、聚(丙交酯-共_ε-己内酯)、聚(乙交酯-共_ε-己内酯)、聚(丙交酯-共-二噁烷酮)、聚(乙交酯-共-二噁烷酮)、聚(丙交酯-共-三亚甲基碳酸酯)、聚(乙交酯-共-三亚甲基碳酸酯)、聚(丙交酯-共-碳酸亚乙酯)、聚(乙交酯-共-碳酸亚乙酯)、聚(丙交酯-共-碳酸丙烯酯)、聚(乙交酯-共-碳酸丙烯酯)、聚(丙交酯-共-2-甲基-2-羧基-碳酸丙烯酯)、聚(乙交酯-共-2-甲基-2-羧基-碳酸丙烯酯)、聚(3-羟基丁酸酯-共-4-羟基丁酸酯)、聚(羟基丁酸酯-共-羟基戊酸酯)、聚(3-羟基丁酸酯-共-3-羟基戊酸酯)、聚(4-羟基丁酸酯-共-3-羟基戊酸酯)、聚“-己内酯-共-富马酸酯)、聚己内酯-共-富马酸丙二 [0008] The biodegradable polymeric material is selected from one or more of the following materials: polyurethane degradable, biodegradable polyesters, from poly (L- lactide - co -D- lactide), poly (L- lactide - co -D, L- lactide), poly (D- lactide - co -D, L_ lactide), poly (lactide - co - glycolide), poly (lactide - co _ε- caprolactone), poly (glycolide - _ε- co-caprolactone), poly (lactide - co - dioxanone), poly (glycolide - co - dioxanone), poly (lactide - co - trimethylene carbonate), poly (glycolide - co - trimethylene carbonate), poly (lactide - co - ethylene carbonate ), poly (glycolide - co - ethylene carbonate), poly (lactide - co - propylene carbonate), poly (glycolide - co - propylene carbonate), poly (lactide - co - methyl-2-carboxy - propylene carbonate), poly (glycolide - co-2-methyl-2-carboxy - propylene carbonate), poly (3-hydroxybutyrate - co-4-hydroxy butyrate), poly (hydroxybutyrate - co - hydroxyvalerate), poly (3-hydroxybutyrate - co-3-hydroxyvalerate), poly (4-hydroxybutyrate - co - 3-hydroxyvalerate), poly "- caprolactone - co - fumarate), polycaprolactone - co - propylene fumarate 酯)、聚(丙交酯-共-乙二醇)、聚(乙交酯-共-乙二醇)、聚(ε -己内酯-共-乙二醇)、聚(DET0SU-1,6-HD-共-DETOSU-t-CDM)、聚(丙交酯-共-乙交酯-共_ ε -己内酯)、聚(丙交酯-共-乙交酯-共-三亚甲基碳酸酯)、聚(丙交酯-共- ε-己内酯-共-三亚甲基碳酸酯)、聚(乙交酯-共-ε-己内酯-共-三亚甲基碳酸酯)和聚(3-羟基丁酸酯-共-3-羟基戊酸酯-共-4-羟基丁酸酯),其中的丙交酯包括L-丙交酯、D-丙交酯和D, L-丙交酯。PVP,PVA,淀粉,生物分子(如纤维蛋白,纤维蛋白原,纤维素,胶原蛋白和透明质酸),聚氨酯,人造丝,人造丝三醋酸纤维素,纤维素,乙酸,丁酸纤维素,醋酸丁酸纤维素,玻璃纸,硝酸纤维素,丙酸纤维素,纤维素,和羧甲基纤维素。 Ester), poly (lactide - co - ethylene glycol), poly (glycolide - co - ethylene glycol), poly ([epsilon] - caprolactone - co - ethylene glycol), poly (DET0SU-1, 6-HD- co -DETOSU-t-CDM), poly (lactide - co - glycolide - co _ [epsilon] - caprolactone), poly (lactide - co - glycolide - co - trimethylene carbonate), poly (lactide - co - caprolactone [epsilon] - co - trimethylene carbonate), poly (glycolide - co-caprolactone -ε- - co - trimethylene carbonate) and poly (3-hydroxybutyrate - co-3-hydroxyvalerate - co-4-hydroxybutyrate), where L- lactide comprising lactide, D- lactide and D, L - lactide .PVP, PVA, starch, biomolecules (such as fibrin, fibrinogen, cellulose, collagen and hyaluronic acid), polyurethanes, rayon, rayon acetate, cellulose triacetate, cellulose acetate, cellulose butyrate, cellulose acetate butyrate, cellophane, cellulose nitrate, cellulose propionate, cellulose, and carboxymethyl cellulose.

[0009] 特别地,该生物可降解高分子材料为PLA和PGA (或PCL)共混的聚合物材料。 [0009] In particular, the polymer material is biodegradable PLA and PGA (or PCL) blended polymeric material. 一方面,该类聚合物已经广泛地应用于血管支架、缝合线、骨科植入物等三类医疗器械产品多年,具有比硅胶材料更好的生物相容性,避免了一些有材料引发的并发症的发生。 In one aspect, such polymers have been widely used vascular stents, sutures, orthopedic implants and other medical devices three years, has a better biocompatibility than a silicone material, to avoid concurrent material caused some the disease occurs. 另一方面,本发明根据支架的鼻泪道的使用部位进行配比,包括根据其支撑强度和降解时间等进行配比以符合本发明的特定的使用部位的要求。 Another aspect, the present invention is used in accordance with the ratio of nasolacrimal duct portion of the stent, including the ratio thereof according to the support strength and degradation time to meet the specific requirements of the site of use of the present invention. 其中,PLA在PGA和PLA共混的聚合物材料中所占的质量百分数至少为50%,优选为70% ;PCL在PLA和PCL共混的聚合物材料中所占的质量百分数至少为50%,优选为70%。 Wherein the mass percentage share of the PLA and PGA PLA polymer material blended in at least 50%, preferably 70%; proportion in mass percentage PCL PLA and PCL polymer material blended in at least 50% , preferably 70%. 如此可以确保鼻泪管支架的降解时间为3-6个月左右,同时支撑强度满足要求。 Thus ensures that the degradation time of the stent nasolacrimal duct is about 3-6 months, while supporting strength to meet the requirements.

[0010] 可共混聚合物除上述的可降解聚合物外,还包括合成和天然的水解降解的聚合物。 [0010] In addition to the polymer blend can be biodegradable polymers, include synthetic and natural further hydrolytic degradation of the polymer. 合成水解可生物降解的聚合物可以包括水解降解聚酯包括聚(L-乳酸-乙醇酸)(PLGA)。 Hydrolysis of synthetic biodegradable polymers can include hydrolyzed biodegradable polyester comprises poly (L- lactic acid - glycolic acid) (PLGA). 典型的天然可生物降解的聚合物包括壳聚糖。 Typical natural biodegradable polymers include chitosan. 典型的水溶性聚合物包括聚(乙二醇)(PEG),PEG嵌段聚合物,PEG/PLA与PEG聚合物,PEG随机或交替共聚物,如聚乙二醇/PLGA共聚物,蔗糖,淀粉,褐藻胶,聚乙烯吡咯烷酮(PVP),和聚(乙烯醇)(PVA)。 Typical water soluble polymers include poly (ethylene glycol) (PEG), PEG block polymers, PEG / PLA polymers with PEG, PEG random or alternating copolymers, such as polyethylene glycol / PLGA copolymers, sucrose, starch, alginate, polyvinylpyrrolidone (PVP), and poly (vinyl alcohol) (PVA). 聚(N-乙酰葡糖胺)(甲壳素),聚(酯),聚(3-羟基丁酸酯),聚(4-羟基丁酸酯),聚(羟基丁酸-羟基戊酸),聚(DL-丙交酯-共-己内酯),聚(乙交酯共£-己内酯),聚(三亚甲基碳酸酯),聚酯酰胺,聚(乙醇酸-三亚甲基碳酸酯),聚(醚-酯)(例如,PEO/聚乳酸),聚磷月青等。 Poly (N- acetylglucosamine) (Chitin), poly (esters), poly (3-hydroxybutyrate), poly (4-hydroxybutyrate), poly (hydroxybutyric acid - hydroxyvaleric acid), poly (DL-lactide - co - caprolactone), poly (glycolide co £ - caprolactone), poly (trimethylene carbonate), polyesteramides, poly (glycolic acid - trimethylene carbonate ester), poly (ether - ester) (e.g., PEO / polylactic acid), polyphosphazenes ilicifolia like.

[0011] 所述网状本体包括支撑环和连接杆,所述支撑环为周向延伸的封闭的正弦波状支撑环,所述连接杆设置于相邻的支撑环之间。 The [0011] the mesh body comprises a support ring and a connecting rod, the support ring is closed sinusoidal support ring extending circumferentially, said connecting rod is disposed between the adjacent support rings. 其中,所述连接杆可以为直线形或其他形状,只要能够将支撑环连接使其形成一体即可。 Wherein the connecting rod may have a linear shape or other shape, as long as it is possible to connect the support ring can be integrally formed.

[0012] 所述支撑环由重复的单元首尾相连形成,所述第一网状本体部分的单元的数目多于所述第二网状本体部分的单元的数目。 [0012] The support ring is formed of repeating units are connected end to end, the number of mesh cells of the second body portion of the number of cells of said first web more than the body portion.

[0013] 所述单元为V形单元,所述第一网状本体部分的V形单元的数目比所述第二网状本体部分的V形单元的数目多2-3个。 [0013] The unit is a V-shaped unit, the number of V-shaped unit in the first plurality of net-like body portion 2-3 units than the number of V-shaped body portion of said second web. 优选地,所述第一网状本体部分的V形单元的数目为7-10个,所述第二网状本体部分的V形单元的数目为5-8个。 Preferably, the number of V-shaped section of the body portion of the first web is 7-10, the number of V-shaped mesh cells of the second body portion 5-8.

[0014] 所述网状本体的外表面上具有抗炎药物或抗粘连药物。 The [0014] outer surface of the mesh body has an anti-inflammatory drug or an anti-blocking drugs. 在鼻泪管支架植入后,网状本体外表面的抗炎药物或抗粘连药物开始向与之接触的鼻泪管释放,减少了鼻泪管内壁的炎症、肉芽生长,并且加快了鼻泪道的愈合。 After nasal lacrimal stent, nasolacrimal duct release anti-inflammatory drugs or outer surface of the web of the present anti-adhesion drugs began to contact therewith, reducing the nasolacrimal canal wall inflammation, granulation, and accelerate the nasolacrimal Road healing.

[0015] 在一些实施例中,抗炎药物包括,但不限于,阿氯芬酸,阿氯米松双丙酸酯,二羟孕酮曲安奈德,α -淀粉酶,安西法尔,安西非特,氨芬酸钠,盐酸氨普立糖,阿那白滞素,阿尼罗酸,阿尼扎芬,阿扎丙宗,巴柳氮钠,苄达赖,盐酸苄达明,菠萝蛋白酶,溴四唑哌啶,布地奈德,卡洛芬,芴丙酸,噌戊唑酮,克利洛芬,丙酸,丙酸氯倍他索,氯吡酸,氯硫卡松丙酸,醋酸可米松,可的松,地夫可特,地奈德,去羟米松,丙酸地塞米松,双氯芬酸钾,钠,醋酸双,二氟米酮钠,二氟尼柳,二氟泼尼酯,双酞嗪酮,二甲基亚砜,羟西奈德,甲地松,恩莫单抗,依诺利康钠,依匹唑,依托度酸,依托芬那酯,联苯乙酸,苯四唑胺,芬布芬,氯酸,氯环苯乙酸,芬度柳,苯吡哌二酮,芬替酸,氟苯哌酮,氟扎可特,氟芬那酸,氟咪唑,醋酸氟尼缩松 [0015] In some embodiments, anti-inflammatory drugs include, but are not limited to, alclofenac, alclometasone dipropionate, triamcinolone acetonide dihydroxy progesterone, α - amylase, Anxifaer, amcinafide , amfenac sodium, amiprilose hydrochloride, anakinra Su, A Niluo acid, Enizhafen, apazone, balsalazide sodium, benzyl Dalai, benzydamine hydrochloride, bromelain, bromotetrazolo piperidine, budesonide, carprofen, fluorene propionate, amyl cinnoline trazodone, ketoprofen Klee, propionate, clobetasol propionate, clopidogrel acid, chloro-propionate sulfur acid, acetic acid can be betamethasone, cortisone, deflazacort, desonide, desoximetasone, dexamethasone propionate, double, two m-fluoro-one sodium diclofenac potassium, sodium acetate, diflunisal, difluprednate ester, double phthalazinone, dimethylsulfoxide, hydroxyalkyl Xinai De, A pine, Enmo monoclonal antibody by sodium Nuoli Kang, oxazole epinastine, etodolac, etofenamate, felbinac, phenyl tetrazole amine , fenbufen, acid, acid chloride ring, fendosal, benzene Bipai dione, fentiazac acid, piperazine-fluorophenyl ketone, fluazacort, flufenamic acid, fluoro imidazole, acetate, flunisolide 氟尼辛,氟尼辛葡甲胺,醋酸氟米龙,氟喹酮,氟,氟瑞托芬,丙酸氟替卡松,呋喃洛芬,制吐剂,氯乙酸,丙酸卤倍他索,卤泼尼松,风湿定,布洛芬,布洛芬铝,布洛芬吡啶甲醇,伊洛普,吲哚美辛吲哚美辛,钠,吲哚洛芬,吲哚克索,醋酸酯,伊索克酸,异恶噻酰胺,酮洛芬,盐酸洛非咪唑,氯诺昔康,氯替泼诺,甲氯芬那酸钠,氯灭酸,二丁酸甲氯松,甲芬那酸,美沙拉嗪,美西拉宗,甲泼尼龙,萘丁美酮,萘普生,萘,萘普索,腈胺唑酮,奥沙拉秦钠,有机磷,奥帕诺辛,奥沙普秦,羟基保泰松,瑞尼托林盐酸盐,保泰松甘油酸钠,吡非尼酮,吡罗昔康,吡罗昔康肉桂酸,吡罗昔康乙醇胺,吡咯洛,强的松龙-奋乃静,普立非酮,普罗度酸,普罗沙唑,枸橼酸普罗沙唑,利美索龙,氯苯扎利,水杨酸胆碱硫酸镁,沙那西定,双水杨酸, Flunixin, flunixin meglumine, fluorometholone acetate, ketone-fluoro-quinoline, fluorine, chlorine Ruituo Fen, fluticasone propionate, furan ketoprofen, manufactured antiemetic, chloroacetic acid, halobetasol propionate, halo prednisone, rheumatism set, ibuprofen, ibuprofen aluminum, ibuprofen-pyridinemethanol, Yiluo Pu, indomethacin, indomethacin sodium, indoprofen, indole pramipexole, acetate, Isoxepac, isoxicam, ketoprofen, Los imidazole hydrochloride, lornoxicam, loteprednol, meclofenamate sodium, meclofenamic acid, di-acid chloride A loose, mefenamic acid, mesalazine, beauty cases Shiraz, methylprednisolone, nabumetone, naproxen, naphthalene, nabumetone cable, nitriles amines trazodone, olsalazine sodium, organophosphorus, Aopanuoxin, Osage Pu Qin, oxyphenbutazone, Ruinituolin hydrochloride, phenylbutazone sodium glycerate, pirfenidone, piroxicam, piroxicam cinnamate, piroxicam ethanolamine, pirprofen, prednisolone - is the Fen static, non PolyOne ketone, an acid of the general, Pu Luosha thiazole, oxazole Pu Luosha citrate, rimexolone, lobenzarit, choline magnesium salicylate, salnacedin, bis salicylic acid, 根叶绿素代理佣金,司克拉宗,丝美辛,湿痛喜康,舒林酸,舒洛芬,他美辛,他尼氟酯,醋柳酞酯,替布费龙,替尼达普,替尼达普钠,替诺昔康,替昔康,苄叉异喹酮,四氢甲吲胺,硫平酸,托美丁,托美汀钠,三氯奈德,三氟氨酯,齐多美辛,蠕孢菌素,阿司匹林(乙酰水杨酸),水杨酸,糖皮质激素,糖皮质激素,他克莫司,以及它们的组合。 Root chlorophyll agency commission, the Secretary-carat cases, silk indomethacin, piroxicam wet, sulindac, suprofen, he indomethacin, Thani fluorine resin, TFH phthalate esters, for cloth Ferron, tenidap, erlotinib da sodium, tenoxicam, for piroxicam, benzal isoquinoline ketone, methyl indole-tetrahydro-amine, quetiapine acid, tolmetin, tolmetin sodium, Ned trichloromethyl, trifluoromethyl urethane, multi Qi indomethacin, creep cyclosporine, aspirin (acetylsalicylic acid), salicylic acid, glucocorticoids, corticosteroids, tacrolimus, and combinations thereof.

[0016] 本发明所述的植入系统,包括上述的鼻泪管支架。 [0016] The implant system according to the present invention, including the above-described stent nasolacrimal duct.

[0017] 所述植入系统还包括球囊导管,所述球囊导管包括用于预装所述鼻泪管支架的球囊,所述球囊由第一球囊部分和第二球囊部分组成;在压缩状态下,所述第一球囊部分与所述第一网状本体部分对齐,所述第二球囊部分与所述第二网状本体部分对齐;在扩张状态下,所述第一球囊部分的直径大于所述第二球囊部分的直径。 [0017] The implant system further comprises a balloon catheter, the balloon catheter comprising a balloon for the pre nasal lacrimal stent, the balloon of the first balloon and second balloon portions composition; in a compressed state, the first balloon web portion aligned with the first body portion, said second portion aligned with the second balloon mesh body portion; in an expanded state, the the balloon diameter of the first portion is greater than the diameter of the second portion of the balloon.

[0018] 本发明的植入系统的球囊导管是根据鼻泪管的解剖结构设计的球囊,从而把鼻泪管支架撑开使鼻泪管支架的外壁贴合鼻泪道,起到使鼻泪道畅通的支撑作用。 [0018] The balloon catheter of the implant system of the present invention is based on the anatomy of the nasolacrimal duct balloon design, so that the nasolacrimal duct outer wall of the stent so that the expansion of the stent nasolacrimal duct bonded nasolacrimal duct, serves to supporting role nasolacrimal duct smooth.

[0019] 在扩张状态下,所述球囊内充盈有造影剂。 [0019] In the expanded state, the inner filling the balloon with a contrast agent. 当然,其他的液体也是可行的,考虑到后期利用X射线进行观察的方便,使用造影剂进行充盈是特别优选的。 Of course, other liquids are also possible, taking into account the post to facilitate observation by X-ray using contrast agents is particularly preferred for filling.

[0020] 所述植入系统还包括鼻泪管扩张器,所述鼻泪管扩张器由鼻泪道扩张器外套管和鼻泪道扩张器内杆组成,所述鼻泪道扩张器内杆至少部分容置于所述鼻泪道扩张器外套管内并与之可拆卸地配合。 [0020] The implant system further comprises a nasal lacrimal stent, a lacrimal nasal dilator nasolacrimal duct by the inner tube and the outer dilator nasolacrimal dilator rods, said nasal dilator rod lacrimal at least partially housed removably fitted to and within the nasal dilator lacrimal overtube. 在进入鼻泪道后,鼻泪道扩张器外套管被留在原位作为一个工作通道,后期的操作都通过该通道进行。 After entering the nasolacrimal duct, nasolacrimal duct dilator outer sleeve is left in place as a working channel, the latter part of the operations are carried out through the channel.

[0021] 所述植入系统还包括照明导丝,所述鼻泪管扩张器沿着所述照明导丝延伸。 [0021] The implant system further comprises illuminating guidewire, the dilator nasolacrimal duct extends along the illumination guidewire. 在植入过程中,首先使用照明导丝从鼻腔入路,使得照明导丝到达泪囊位置,然后沿着照明导丝把鼻泪管扩张器植入鼻泪道中,抽出鼻泪道扩张器内杆,鼻泪道扩张器外套管留置于鼻泪管内作为手术工作通道。 During implantation, using the first guidewire from the nasal cavity into the illumination path, such that the position of the illuminating guidewire reaches the lacrimal sac and the nasal illuminating guidewire along the lacrimal implant nasolacrimal duct dilator, the dilator out the nasolacrimal duct rod, nasolacrimal duct dilator is placed inside the outer sleeve as the nasolacrimal duct surgery working channel. 把预装在球囊导管上的鼻泪管支架系统沿鼻泪道扩张器外套管送入鼻泪管内,对球囊导管加压,实现支架的扩张。 The pre-installed on the balloon catheter stent nasolacrimal duct system dilator along the nasolacrimal duct into the outer tube nasolacrimal duct of a pressurized balloon catheter, to achieve expansion of the stent. 这样不再通过从泪小管牵引植入的方法把鼻泪管支架拉入鼻泪道中,而完全采用从鼻腔入路,从而避免了现有植入方法的弊端,使鼻泪管支架的植入更方便和容易,对病人的伤害最小化。 Such methods are no longer pulled by the implant from the canaliculus into the nasal lacrimal stent pull the nasolacrimal duct, and completely from the nasal cavity into the channel, thereby avoiding the drawbacks of the conventional method of implanting the stent nasal lacrimal implant more convenient and easy, minimizing injury to the patient.

[0022] 所述照明导丝由螺旋弹簧、透镜和光缆组成,所述透镜固定于所述光缆的照明端,所述螺旋弹簧在所述照明端缠绕在所述光缆的外部。 [0022] The illuminating guidewire coil spring, and optical lens composed of the illumination lens is fixed to an end of the optical cable, the lighting end of said coil spring wound around the exterior of the optical cable. 替代现有的泪小管导丝,本发明提供的照明导丝从鼻腔入路,由于鼻腔粗大,不会对鼻泪道产生损害,而且病患的所感受的痛苦得到极大的降低。 Alternatively canaliculus conventional guidewire, the present invention provides an illuminating guidewire from the nasal passage, nasal coarse because, no damage to the nasolacrimal duct, and the pain felt by the patient is greatly reduced.

[0023] 所述照明导丝由螺旋弹簧、透镜和光缆组成,所述透镜固定于所述光缆的照明端,所述螺旋弹簧在所述照明端缠绕在所述光缆的外部。 [0023] The illuminating guidewire coil spring, and optical lens composed of the illumination lens is fixed to an end of the optical cable, the lighting end of said coil spring wound around the exterior of the optical cable.

[0024] 在管腔重建完成后,本发明的可完全降解的网状的鼻泪管支架最后生成水和二氧化碳通过鼻腔排出,避免了二次手术,减免了病患痛苦。 [0024] After the completion of the reconstruction lumen, the mesh can be completely degraded invention nasolacrimal duct stent final water and carbon dioxide is discharged through the nose, to avoid a second surgery, the patient pain relief. 该鼻泪管支架适合于从鼻腔入路,从而避免了现有的从眼上方入路对泪小管和鼻泪道内膜的损害。 The stent is adapted to nasolacrimal duct from the nasal cavity into the channel, thereby avoiding the conventional approach from above the eye damage to the lacrimal canaliculus and the nasolacrimal duct lining. 该鼻泪管支架通过药物涂层实现药物缓释功效,从而长时间对鼻泪道进行持续治疗。 The nasal lacrimal stent drug release achieved by the efficacy of the drug coating, so that on long continuous treatment of nasolacrimal duct.

附图说明 BRIEF DESCRIPTION

[0025] 图1是根据本发明的植入系统的鼻泪管支架的平面展开图; [0025] FIG. 1 is a development view of a planar nasolacrimal implant system of the present invention the stent;

[0026] 图2是根据本发明的植入系统的球囊导管的透视图; [0026] FIG. 2 is a perspective view of the balloon catheter of the implant system according to the present invention;

[0027] 图3是根据本发明的植入系统的照明导丝的透视图; [0027] FIG. 3 is a perspective view of an illuminating guidewire implant system according to the present invention;

[0028] 图4是根据本发明的植入系统的鼻泪管扩张器的透视图; [0028] FIG. 4 is a perspective view of nasal dilator lacrimal implant system according to the invention;

[0029] 图5是根据本发明的植入系统的鼻泪道扩张器外套管的透视图; [0029] FIG. 5 is a perspective view of the implant system of the present invention nasolacrimal duct dilator outer tube;

[0030] 图6是根据本发明的植入系统的鼻泪道扩张器内杆的透视图。 [0030] FIG. 6 is a perspective view of nasal dilator lacrimal implant system according to the present invention the rod.

具体实施方式 Detailed ways

[0031] 下面结合附图,给出本发明的较佳实施例,并予以详细描述。 Preferred [0031] DRAWINGS given embodiment of the present invention, and be described in detail.

[0032] 根据本发明的植入系统的鼻泪管支架是套筒状的支架,为了叙述方便,图1给出了该鼻泪管支架的平面展开图。 [0032] The nasal lacrimal stent system of the present invention is a sleeve-like holder for convenience of description, FIG. 1 shows the plane of the nasal lacrimal stent deployment FIG. 鼻泪管支架I包括由生物可降解高分子材料形成的具有孔隙的网状本体11,例如可以通过在可降解聚合物材料的挤出管材上进行激光雕刻成网孔状结构。 I nasal lacrimal stent comprises a biodegradable polymeric material forming a mesh body having apertures 11, for example, laser engraving into a net-like structure in the extrusion tube by the degradable polymeric material. 该网状本体11包括支撑环111和连接杆112,其中,支撑环111为周向延伸的封闭的正弦波状支撑环,每个支撑环由重复的V形单元Illa首尾相连形成。 The mesh body 11 includes a support ring 111 and connecting rod 112, wherein support ring 111 is closed sinusoidal circumferentially extending support ring, the support ring connected to each V-shape is formed by repeating units Illa inclusive. 连接杆112设置于相邻的支撑环111之间。 Connecting rod 112 is disposed between the adjacent support ring 111. 支撑环111主要对堵塞的鼻泪管起支撑作用,支撑环111之间通过连接杆112形成一个整体。 The support ring 111 mainly nasolacrimal duct blockage play a supportive role, between the support ring 111 is formed integrally by a connecting rod 112. 网状本体11由彼此相连的第一网状本体部分Ila和第二网状本体部分Ilb组成,其中第一网状本体部分Ila植入于鼻泪道的上段,即靠近泪囊部分,第二网状本体部分Ilb植入于鼻泪道的下端,即近鼻泪管鼻腔开口位置。 A first mesh net body 11 and a second body portion Ila Ilb mesh body portion connected to each other by a composition, wherein the first mesh is implanted in the body portion Ila nasolacrimal duct upper section, i.e. close to the lacrimal sac portion, a second Ilb mesh implant body portion to the lower end of the nasolacrimal duct, i.e. near nasolacrimal duct nasal opening position. 构成第一网状本体部分Ila的支撑环111的V形单元Illa的数目多于第二网状本体部分Ilb的支撑环111的V形单元11 Ia的数目。 Supporting a first number constituting the mesh body portion V-shaped ring Ila Illa de unit 111 is greater than the second number Ilb mesh body portion 11 Ia of the V-ring 111 of the support unit. 通常,构成第一网状本体部分Ila的支撑环111的V形单元11 Ia的数目为7-10个,构成第二网状本体部分I Ib的支撑环111的V形单元11 Ia的数目为5_8个,第一网状本体部分Ila的支撑环111的V形单元Illa的数目优选为比构成第二网状本体部分Ilb的支撑环111的V形单元Illa的数目多2_3个。 Typically, the number of V-shaped section of the support ring 111 constituting the first web Ila of the body portion 11 Ia is 7-10, the number of V-shaped mesh element constitutes a second body portion of the I Ib 11 Ia of the support ring 111 is 5_8 months, the number of the first body portion Ila mesh-shaped supporting unit Illa V ring 111 is preferably configured to support the second mesh than the body portion Ilb number of V-ring unit 111 Illa a plurality 2_3. 该鼻泪管支架具有两个状态——压缩状态和扩张状态。 The nasal lacrimal stent has two states - a compressed state and an expanded state. 在压缩状态下,第一网状本体部分Ila和第二网状本体部分Ilb具有相同的直径;在扩张状态下,第一网状本体部分Ila的直径大于第二网状本体部分Ilb的直径。 In the compressed state, the first web and a second body portion Ila Ilb mesh body portion having the same diameter; in an expanded state, the diameter of the first body portion Ila mesh larger than the diameter of the second mesh body portion Ilb. 如此,在扩张后,该鼻泪管支架借助于大直径的第一网状本体部分Ila固定于靠近泪囊部分,防止其不经意地从鼻腔中脱出。 Thus, after expansion, the stent by means of a nasal lacrimal large diameter portion of the first web Ila fixed to the body portion near the lacrimal sac, which prevent inadvertently released from the nasal cavity. 通常,支撑环111的宽度Wl为0.1-0.5mm,优选为0.2-0.3mmο连接杆112的宽度W2优选为0.1-0.3mm,该连接杆112可以是如图1所示的直线形,也可以是其他形状。 Typically, the support ring width Wl 111 is 0.1-0.5 mm, preferably 0.2-0.3mmο width W2 of the connecting rod 112 is preferably 0.1-0.3 mm, the connecting rod 112 may be straight as shown in FIG. 1, may be other shapes. 该鼻泪管支架的厚度可以是0.1mm, 0.2mm, 0.3mm, 0.4mm, The thickness of the nasal lacrimal stent may be 0.1mm, 0.2mm, 0.3mm, 0.4mm,

0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1.0mm,优选为0.2-0.5mm。 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm, 1.0mm, preferably 0.2-0.5mm.

[0033] 网状本体11的外表面上具有抗炎药物或抗粘连药物。 The outer surface of the [0033] mesh body 11 having an anti-inflammatory drug or an anti-blocking drugs. 优选地,网状本体11的外表面上通过喷涂而形成抗炎药物或抗粘连药物的药物涂层,从而借助于药物的释放而防止鼻泪道内炎症和肉芽生长。 Preferably, the outer surface of the mesh body 11 formed by anti-inflammatory drugs or anti-adhesion medicament drug coating layer by spraying, so that by means of the release of drug to prevent the growth of granulation and inflammation within the nasal lacrimal duct. 该抗炎药物包括,但不限于,阿氯芬酸,阿氯米松双丙酸酯,二羟孕酮曲安奈德,α -淀粉酶,安西法尔,安西非特,氨芬酸钠,盐酸氨普立糖,阿那白滞素,阿尼罗酸,阿尼扎芬,阿扎丙宗,巴柳氮钠,苄达赖,盐酸苄达明,菠萝蛋白酶,溴四唑哌啶,布地奈德,卡洛芬,芴丙酸,噌戊唑酮,克利洛芬,丙酸,丙酸氯倍他索,氯吡酸,氯硫卡松丙酸,醋酸可米松,可的松,地夫可特,地奈德,去羟米松,丙酸地塞米松,双氯芬酸钾,钠,醋酸双,二氟米酮钠,二氟尼柳,二氟泼尼酯,双酞嗪酮,二甲基亚砜,羟西奈德,甲地松,恩莫单抗,依诺利康钠,依匹唑,依托度酸,依托芬那酯,联苯乙酸,苯四唑胺,芬布芬,氯酸,氯环苯乙酸,芬度柳,苯吡哌二酮,芬替酸,氟苯哌酮,氟扎可特,氟芬那酸,氟咪唑,醋酸氟尼缩松,氟尼辛,氟尼辛葡甲 The anti-inflammatory drugs include, but are not limited to, alclofenac, alclometasone dipropionate, triamcinolone acetonide dihydroxy progesterone, α - amylase, Anxifaer, amcinafide, amfenac sodium, ammonia hydrochloride Pulitzer sugar, Kineret® A, A Niluo acid, Enizhafen, apazone, balsalazide sodium, benzyl Dalai, benzydamine hydrochloride, bromelain, bromo tetrazole, piperidine, budesonide Germany, carprofen, fluorene propionate, amyl cinnoline trazodone, ketoprofen Klee, propionate, clobetasol propionate, clopidogrel acid, chloroplatinic acid sulfur propionate, betamethasone acetate may, cortisone, Cardiff be special, desonide, desoximetasone, dexamethasone propionate, diclofenac potassium, sodium diacetate, sodium meters difluoro ketone, diflunisal, difluprednate, bis phthalazinone, dimethyl sulfoxides, hydroxyalkyl Xinai De, A pine, Enmo monoclonal antibody by sodium Nuoli Kang, oxazole epinastine, etodolac, etofenamate, felbinac, phenyl tetrazole amine, fenbufen, chlorate, cyclic acid chloride, fendosal, benzene Bipai dione, fentiazac acid, piperazine-fluorophenyl ketone, fluazacort, flufenamic acid, imidazole-fluoro, flunisolide acetate, flunixin, flunixin meglumine 胺,醋酸氟米龙,氟喹酮,氟,氟瑞托芬,丙酸氟替卡松,呋喃洛芬,制吐剂,氯乙酸,丙酸卤倍他索,卤泼尼松,风湿定,布洛芬,布洛芬铝,布洛芬吡啶甲醇,伊洛普,吲哚美辛吲哚美辛,钠,吲哚洛芬,吲哚克索,醋酸酯,伊索克酸,异恶噻酰胺,酮洛芬,盐酸洛非咪唑,氯诺昔康,氯替泼诺,甲氯芬那酸钠,氯灭酸,二丁酸甲氯松,甲芬那酸,美沙拉嗪,美西拉宗,甲泼尼龙,萘丁美酮,萘普生,萘,萘普索,腈胺唑酮,奥沙拉秦钠,有机磷,奥帕诺辛,奥沙普秦,羟基保泰松,瑞尼托林盐酸盐,保泰松甘油酸钠,吡非尼酮,吡罗昔康,吡罗昔康肉桂酸,吡罗昔康乙醇胺,吡咯洛,强的松龙-奋乃静,普立非酮,普罗度酸,普罗沙唑,枸橼酸普罗沙唑,利美索龙,氯苯扎利,水杨酸胆碱硫酸镁,沙那西定,双水杨酸,血根叶绿素代理佣金, Amine, fluorometholone acetate, ketone-fluoro-quinoline, fluorine, chlorine Ruituo Fen, fluticasone propionate, furan ketoprofen, manufactured antiemetic, chloroacetic acid, halobetasol propionate, halopredone, rheumatism set, Bullock Fen, ibuprofen aluminum, ibuprofen-pyridinemethanol, Yiluo Pu, indomethacin, indomethacin sodium, indoprofen, indole pramipexole, acetate, Isoxepac, isoxicam , ketoprofen, Los imidazole hydrochloride, lornoxicam, loteprednol, meclofenamate sodium, meclofenamic acid, di-acid chloride A loose mefenamic acid, mesalamine, US Shiraz cases, methylprednisolone, nabumetone, naproxen, naphthalene, nabumetone cable, nitriles amines trazodone, olsalazine sodium, organophosphorus, Aopanuoxin, oxaprozin, oxyphenbutazone, Sweden Ni Tuolin hydrochloride, phenylbutazone sodium glycerate, pirfenidone, piroxicam, piroxicam cinnamate, piroxicam ethanolamine, pirprofen, prednisolone - perphenazine, PolyOne non ketone, of general acid, Pu Luosha thiazole, oxazole Pu Luosha citrate, rimexolone, lobenzarit, choline magnesium salicylate, salnacedin, disalicylate, sanguinarine chlorophyll agent commission, 司克拉宗,丝美辛,湿痛喜康,舒林酸,舒洛芬,他美辛,他尼氟酯,醋柳酞酯,替布费龙,替尼达普,替尼达普钠,替诺昔康,替昔康,苄叉异喹酮,四氢甲吲胺,硫平酸,托美丁,托美汀钠,三氯奈德,三氟氨酯,齐多美辛,蠕孢菌素,阿司匹林(乙酰水杨酸),水杨酸,糖皮质激素,糖皮质激素,他克莫司,以及它们的组合。 Division carat cases, silk indomethacin, piroxicam wet, sulindac, suprofen, he indomethacin, Thani fluorine resin, TFH phthalate esters, for cloth Ferron, tenidap, tenidap sodium, for lornoxicam, for piroxicam, benzal isoquinoline ketone, methyl indole-tetrahydro-amine, quetiapine acid, tolmetin, tolmetin sodium, Ned trichloromethyl, trifluoromethyl urethane, homogeneous multi indomethacin, Helminthosporium streptozotocin, aspirin (acetylsalicylic acid), salicylic acid, glucocorticoids, corticosteroids, tacrolimus, and combinations thereof.

[0034] 形成网状本体11的生物可降解高分子材料选自以下材料中的一种或几种:可降解聚胺酯,可降解聚酯,自聚(L-丙交酯-共-D-丙交酯)、聚(L-丙交酯-共-D,L-丙交酯)、聚(D-丙交酯-共-D,L-丙交酯)、聚(丙交酯-共-乙交酯)、聚(丙交酯-共-ε -己内酯)、聚(乙交酯-共-ε-己内酯)、聚(丙交酯-共-二噁烷酮)、聚(乙交酯-共-二噁烷酮)、聚(丙交酯-共-三亚甲基碳酸酯)、聚(乙交酯-共-三亚甲基碳酸酯)、聚(丙交酯-共-碳酸亚乙酯)、聚(乙交酯-共-碳酸亚乙酯)、聚(丙交酯-共-碳酸丙烯酯)、聚(乙交酯-共-碳酸丙烯酯)、聚(丙交酯-共-2-甲基-2-羧基-碳酸丙烯酯)、聚(乙交酯-共-2-甲基-2-羧基-碳酸丙烯酯)、聚(3-羟基丁酸酯-共-4-羟基丁酸酯)、聚(羟基丁酸酯-共-羟基戊酸酯)、聚(3-羟基丁酸酯-共-3-羟基戊酸酯)、聚(4-羟基丁酸酯-共-3-羟基戊酸酯)、聚(ε -己内酯-共-富马酸酯)、聚(ε -己 [0034] Biological mesh body 11 formed of biodegradable polymeric material is selected from one or more of the following materials: polyurethane degradable, biodegradable polyesters, from poly (L- lactide - co propan -D- lactide), poly (L- lactide - co -D, L- lactide), poly (D- lactide - co -D, L- lactide), poly (lactide - co - glycolide), poly (lactide - co - [epsilon] - caprolactone), poly (glycolide - -ε- co-caprolactone), poly (lactide - co - dioxanone), poly (glycolide - co - dioxanone), poly (lactide - co - trimethylene carbonate), poly (glycolide - co - trimethylene carbonate), poly (lactide - co - ethylene carbonate), poly (glycolide - co - ethylene carbonate), poly (lactide - co - propylene carbonate), poly (glycolide - co - propylene carbonate), poly (propyl lactide - co-2-methyl-2-carboxy - propylene carbonate), poly (glycolide - co-2-methyl-2-carboxy - propylene carbonate), poly (3-hydroxybutyrate - co-4-hydroxybutyrate), poly (hydroxybutyrate - co - hydroxyvalerate), poly (3-hydroxybutyrate - co-3-hydroxyvalerate), poly (4-hydroxybutyrate esters - co-3-hydroxyvalerate), poly ([epsilon] - caprolactone - co - fumarate), poly ([epsilon] - hexyl 内酯-共-富马酸丙二醇酯)、聚(丙交酯-共-乙二醇)、聚(乙交酯-共-乙二醇)、聚(ε -己内酯-共-乙二醇)、聚(DET0SU-1,6-HD-共-DETOSU-t-CDM)、聚(丙交酯-共-乙交酯-共-ε -己内酯)、聚(丙交酯-共-乙交酯-共-三亚甲基碳酸酯)、聚(丙交酯-共- ε-己内酯-共-三亚甲基碳酸酯)、聚(乙交酯-共-ε-己内酯-共-三亚甲基碳酸酯)和聚(3-羟基丁酸酯-共-3-羟基戊酸酯-共-4-羟基丁酸酯),其中的丙交酯包括L-丙交酯、D-丙交酯和D, L-丙交酯。 Lactones - co - propylene fumarate), poly (lactide - co - ethylene glycol), poly (glycolide - co - ethylene glycol), poly ([epsilon] - caprolactone - co - ethylene alcohol), poly (DET0SU-1,6-HD- co -DETOSU-t-CDM), poly (lactide - co - glycolide - co - [epsilon] - caprolactone), poly (lactide - co - lactide - co - trimethylene carbonate), poly (lactide - co - caprolactone [epsilon] - co - trimethylene carbonate), poly (glycolide - co-caprolactone -ε- - co - trimethylene carbonate) and poly (3-hydroxybutyrate - co-3-hydroxyvalerate - co-4-hydroxybutyrate), where L- lactide comprising lactide, D- lactide and D, L- lactide. PVP,PVA,淀粉,生物分子(如纤维蛋白,纤维蛋白原,纤维素,胶原蛋白和透明质酸),聚氨酯,人造丝,人造丝三醋酸纤维素,纤维素,乙酸,丁酸纤维素,醋酸丁酸纤维素,玻璃纸,硝酸纤维素,丙酸纤维素,纤维素,和羧甲基纤维素。 PVP, PVA, starch, biomolecules (such as fibrin, fibrinogen, cellulose, collagen and hyaluronic acid), polyurethanes, rayon, rayon acetate, cellulose triacetate, cellulose acetate, cellulose butyrate, cellulose acetate butyrate, cellophane, cellulose nitrate, cellulose propionate, cellulose, and carboxymethyl cellulose.

[0035] 特别地,该生物可降解高分子材料为PLA和PGA (或PCL)共混的聚合物材料。 [0035] In particular, the polymer material is biodegradable PLA and PGA (or PCL) blended polymeric material. 一方面,该类聚合物已经广泛地应用于血管支架、缝合线、骨科植入物等三类医疗器械产品多年,具有比硅胶材料更好的生物相容性,避免了一些有材料引发的并发症的发生。 In one aspect, such polymers have been widely used vascular stents, sutures, orthopedic implants and other medical devices three years, has a better biocompatibility than a silicone material, to avoid concurrent material caused some the disease occurs. 另一方面,本发明根据支架的鼻泪管的使用部位进行配比,包括根据其支撑强度和降解时间等进行配比以符合本发明的特定的使用部位的要求。 Another aspect, the present invention is used in accordance with the ratio of parts of the nasal lacrimal stent, including the ratio thereof according to the support strength and degradation time to meet the specific requirements of the site of use of the present invention. 其中,PLA在PGA和PLA共混的聚合物材料中所占的质量百分数至少为50%,优选为70% ;PCL在PLA和PCL共混的聚合物材料中所占的质量百分数至少为50%,优选为70%。 Wherein the mass percentage share of the PLA and PGA PLA polymer material blended in at least 50%, preferably 70%; proportion in mass percentage PCL PLA and PCL polymer material blended in at least 50% , preferably 70%. 如此可以确保鼻泪管支架的降解时间为3-6个月左右,同时支撑强度满足要求。 Thus ensures that the degradation time of the stent nasolacrimal duct is about 3-6 months, while supporting strength to meet the requirements.

[0036] 可共混聚合物除上述的可降解聚合物外,还包括合成和天然的水解降解的聚合物。 [0036] In addition to the polymer blend can be biodegradable polymers, include synthetic and natural further hydrolytic degradation of the polymer. 合成水解可生物降解的聚合物可以包括水解降解聚酯包括聚(L-乳酸-乙醇酸)(PLGA)。 Hydrolysis of synthetic biodegradable polymers can include hydrolyzed biodegradable polyester comprises poly (L- lactic acid - glycolic acid) (PLGA). 典型的天然可生物降解的聚合物包括壳聚糖。 Typical natural biodegradable polymers include chitosan. 典型的水溶性聚合物包括聚(乙二醇)(PEG),PEG嵌段聚合物,PEG/PLA与PEG聚合物,PEG随机或交替共聚物,如聚乙二醇/PLGA共聚物,蔗糖,淀粉,褐藻胶,聚乙烯吡咯烷酮(PVP),和聚(乙烯醇)(PVA)。 Typical water soluble polymers include poly (ethylene glycol) (PEG), PEG block polymers, PEG / PLA polymers with PEG, PEG random or alternating copolymers, such as polyethylene glycol / PLGA copolymers, sucrose, starch, alginate, polyvinylpyrrolidone (PVP), and poly (vinyl alcohol) (PVA). 聚(N-乙酰葡糖胺)(甲壳素),聚(酯),聚(3-羟基丁酸酯),聚(4-羟基丁酸酯),聚(羟基丁酸-羟基戊酸),聚(DL-丙交酯-共-己内酯),聚(乙交酯共£-己内酯),聚(三亚甲基碳酸酯),聚酯酰胺,聚(乙醇酸-三亚甲基碳酸酯),聚(醚-酯)(例如,PEO/聚乳酸),聚磷腈等。 Poly (N- acetylglucosamine) (Chitin), poly (esters), poly (3-hydroxybutyrate), poly (4-hydroxybutyrate), poly (hydroxybutyric acid - hydroxyvaleric acid), poly (DL-lactide - co - caprolactone), poly (glycolide co £ - caprolactone), poly (trimethylene carbonate), polyesteramides, poly (glycolic acid - trimethylene carbonate ester), poly (ether - ester) (e.g., PEO / polylactic acid), polyphosphazene like.

[0037] 图2示出了根据本发明的植入系统的用于预装所述鼻泪管支架I的球囊导管2,包括球囊21,导管22和鲁尔连接件23。 [0037] FIG. 2 shows the implant system of the invention for the pre-nasal lacrimal balloon catheter stent 2 I, and includes a balloon 21, catheter 22 and the luer connector 23. 其中,球囊21由第一球囊部分21a和第二球囊部分21b组成。 Wherein the balloon is a first balloon portion 21 of balloon 21a and the second portion 21b composed. 在图2所示的实施例中,该球囊21示出为阶梯型球囊,在扩张状态下,第一球囊部分21a的直径比第二球囊部分21b的直径大2-5mm,优选为大2_3mm。 In the embodiment illustrated in FIG. 2, the balloon 21 is shown as a stepped balloon in an expanded state, the balloon diameter of the first portion 21a having a larger diameter than the portion 21b of the second balloon 2-5 mm, preferably large 2_3mm. 当然,该球囊21也可以是其他的变直径球囊,例如平缓过渡的锥形球囊。 Of course, the balloon 21 may be another variable diameter balloon, e.g. smooth transition of the balloon cone. 为了将鼻泪管支架I的网状本体11形成所需的形状,第一球囊部分21a与第一网状本体部分IIa对齐,第二球囊部分21b与第二网状本体部分Ilb对齐。 For nasal lacrimal stent mesh body 11 I form a desired shape, a first portion 21a and the balloon body portion IIa aligned first web, a second portion 21b and the balloon body portion Ilb second mesh alignment. 通过该球囊导管,可以使得本发明的鼻泪管支架I采用下鼻腔入路方式,从鼻泪管鼻腔开口位置送入鼻泪管支架I。 With this balloon catheter, the stent may cause nasal lacrimal I of the invention using the approach mode nasal, nasolacrimal duct into the nasolacrimal duct stent from nasal opening position I. 当鼻泪管支架I达到病变位置后,使用加压设备,如充盈器,连接球囊导管的鲁尔连接件23,通过对导管22充盈造影剂扩张球囊21,把鼻泪管支架I撑开。 When nasal lacrimal stent I reaches the position of the lesion, using a pressurized device, such as a filling, a balloon catheter is connected luer connector 23, the conduit 22 by filling the contrast agent dilatation balloon 21, the stent I nasolacrimal duct stays open. 由于第一球囊部分21a和第二球囊部分21b的直径不同,则扩张状态下的第一网状本体部分Ila和第二网状本体部分Ilb的直径也不相同,大直径的第一网状本体部分Ila对应于泪囊位置,这样可以防止支架下滑移位。 Since the first balloon 21a and the second portion 21b of balloon portions of different diameters, the diameter of the body portion of the first web and a second web Ila Ilb body portion in the expanded state is not the same, a large diameter first wire Ila-shaped body portion corresponding to the position of the lacrimal sac so that the bracket can be prevented from falling displacement. 然后泄压撤除球囊导管2,鼻泪管支架I留在鼻泪管内起到使鼻泪道畅通的支撑作用。 The balloon catheter is then removed relief 2, I nasolacrimal duct stent left in the nasolacrimal duct nasolacrimal duct serves to smooth supporting role. 在管腔重建完成后,该可完全降解的网状的鼻泪管支架逐渐降解,最后生成水和二氧化碳通过鼻腔排出。 After the completion of the reconstruction lumen, the mesh can be completely degraded nasal lacrimal stent is gradually degraded and finally water and carbon dioxide is discharged through the nasal cavity.

[0038] 球囊导管2也可以单独使用,即不预装鼻泪管支架。 [0038] The balloon catheter 2 may be used alone, i.e., not pre nasolacrimal stent. 球囊21的外表面上可具有抗炎药物或抗粘连药物,当球囊扩张时,和鼻泪管壁相接触。 The outer surface of the balloon 21 may have anti-inflammatory drug or an anti-blocking drugs, when the balloon, and nasolacrimal wall contact. 球囊上药物直接作用于鼻泪道。 The drug acts directly on the balloon nasolacrimal duct. 该抗炎药物包括,但不限于,阿氯芬酸,阿氯米松双丙酸酯,二羟孕酮曲安奈德,α -淀粉酶,安西法尔,安西非特,氨芬酸钠,盐酸氨普立糖,阿那白滞素,阿尼罗酸,阿尼扎芬,阿扎丙宗,巴柳氮钠,苄达赖,盐酸苄达明,菠萝蛋白酶,溴四唑哌啶,布地奈德,卡洛芬,芴丙酸,噌戊唑酮,克利洛芬,丙酸,丙酸氯倍他索,氯吡酸,氯硫卡松丙酸,醋酸可米松,可的松,地夫可特,地奈德,去羟米松,丙酸地塞米松,双氯芬酸钾,钠,醋酸双,二氟米酮钠,二氟尼柳,二氟泼尼酯,双酞嗪酮,二甲基亚砜,羟西奈德,甲地松,恩莫单抗,依诺利康钠,依匹唑,依托度酸,依托芬那酯,联苯乙酸,苯四唑胺,芬布芬,氯酸,氯环苯乙酸,芬度柳,苯吡哌二酮,芬替酸,氟苯哌酮,氟扎可特,氟芬那酸,氟咪唑,醋酸氟尼缩松,氟尼辛,氟尼辛葡甲 The anti-inflammatory drugs include, but are not limited to, alclofenac, alclometasone dipropionate, triamcinolone acetonide dihydroxy progesterone, α - amylase, Anxifaer, amcinafide, amfenac sodium, ammonia hydrochloride Pulitzer sugar, Kineret® A, A Niluo acid, Enizhafen, apazone, balsalazide sodium, benzyl Dalai, benzydamine hydrochloride, bromelain, bromo tetrazole, piperidine, budesonide Germany, carprofen, fluorene propionate, amyl cinnoline trazodone, ketoprofen Klee, propionate, clobetasol propionate, clopidogrel acid, chloroplatinic acid sulfur propionate, betamethasone acetate may, cortisone, Cardiff be special, desonide, desoximetasone, dexamethasone propionate, diclofenac potassium, sodium diacetate, sodium meters difluoro ketone, diflunisal, difluprednate, bis phthalazinone, dimethyl sulfoxides, hydroxyalkyl Xinai De, A pine, Enmo monoclonal antibody by sodium Nuoli Kang, oxazole epinastine, etodolac, etofenamate, felbinac, phenyl tetrazole amine, fenbufen, chlorate, cyclic acid chloride, fendosal, benzene Bipai dione, fentiazac acid, piperazine-fluorophenyl ketone, fluazacort, flufenamic acid, imidazole-fluoro, flunisolide acetate, flunixin, flunixin meglumine 胺,醋酸氟米龙,氟喹酮,氟,氟瑞托芬,丙酸氟替卡松,呋喃洛芬,制吐剂,氯乙酸,丙酸卤倍他索,卤泼尼松,风湿定,布洛芬,布洛芬铝,布洛芬吡啶甲醇,伊洛普,吲哚美辛吲哚美辛,钠,吲哚洛芬,吲哚克索,醋酸酯,伊索克酸,异恶噻酰胺,酮洛芬,盐酸洛非咪唑,氯诺昔康,氯替泼诺,甲氯芬那酸钠,氯灭酸,二丁酸甲氯松,甲芬那酸,美沙拉嗪,美西拉宗,甲泼尼龙,萘丁美酮,萘普生,萘,萘普索,腈胺唑酮,奥沙拉秦钠,有机磷,奥帕诺辛,奥沙普秦,羟基保泰松,瑞尼托林盐酸盐,保泰松甘油酸钠,吡非尼酮,吡罗昔康,吡罗昔康肉桂酸,吡罗昔康乙醇胺,吡咯洛,强的松龙-奋乃静,普立非酮,普罗度酸,普罗沙唑,枸橼酸普罗沙唑,利美索龙,氯苯扎利,水杨酸胆碱硫酸镁,沙那西定,双水杨酸,血根叶绿素代理佣金, Amine, fluorometholone acetate, ketone-fluoro-quinoline, fluorine, chlorine Ruituo Fen, fluticasone propionate, furan ketoprofen, manufactured antiemetic, chloroacetic acid, halobetasol propionate, halopredone, rheumatism set, Bullock Fen, ibuprofen aluminum, ibuprofen-pyridinemethanol, Yiluo Pu, indomethacin, indomethacin sodium, indoprofen, indole pramipexole, acetate, Isoxepac, isoxicam , ketoprofen, Los imidazole hydrochloride, lornoxicam, loteprednol, meclofenamate sodium, meclofenamic acid, di-acid chloride A loose mefenamic acid, mesalamine, US Shiraz cases, methylprednisolone, nabumetone, naproxen, naphthalene, nabumetone cable, nitriles amines trazodone, olsalazine sodium, organophosphorus, Aopanuoxin, oxaprozin, oxyphenbutazone, Sweden Ni Tuolin hydrochloride, phenylbutazone sodium glycerate, pirfenidone, piroxicam, piroxicam cinnamate, piroxicam ethanolamine, pirprofen, prednisolone - perphenazine, PolyOne non ketone, of general acid, Pu Luosha thiazole, oxazole Pu Luosha citrate, rimexolone, lobenzarit, choline magnesium salicylate, salnacedin, disalicylate, sanguinarine chlorophyll agent commission, 司克拉宗,丝美辛,湿痛喜康,舒林酸,舒洛芬,他美辛,他尼氟酯,醋柳酞酯,替布费龙,替尼达普,替尼达普钠,替诺昔康,替昔康,苄叉异喹酮,四氢甲吲胺,硫平酸,,托美丁,托美汀钠,三氯奈德,三氟氨酯,齐多美辛,蠕孢菌素,阿司匹林(乙酰水杨酸),水杨酸,糖皮质激素,糖皮质激素,他克莫司,以及它们的组合。 Division carat cases, silk indomethacin, piroxicam wet, sulindac, suprofen, he indomethacin, Thani fluorine resin, TFH phthalate esters, for cloth Ferron, tenidap, tenidap sodium, for lornoxicam, for piroxicam, benzal isoquinoline ketone, methyl indole-tetrahydro-amine, quetiapine acid ,, tolmetin, tolmetin sodium, Ned trichloromethyl, trifluoromethyl urethane, homogeneous multi indomethacin, creep cyclosporine, aspirin (acetylsalicylic acid), salicylic acid, glucocorticoids, corticosteroids, tacrolimus, and combinations thereof.

[0039] 本发明的植入系统还包括植入工具,该植入工具包括照明导丝3和鼻泪管扩张器4,其中,图3示出了照明导丝;图4_图6示出了鼻泪管扩张器。 [0039] The implant system according to the present invention further comprises implantation tool, the implant tool comprises illuminating guidewire 3 and the nasolacrimal duct dilator 4, wherein FIG. 3 illustrates an illumination guidewire; FIG. 6 illustrates 4_ the nasolacrimal duct dilator. 首先使用照明导丝3从鼻腔入路,使得照明导丝3到达泪囊位置,然后沿着照明导丝把鼻泪管扩张器4植入鼻泪道中,抽出鼻泪道扩张器内杆42,鼻泪道扩张器外套管41留置于鼻泪管内作为手术工作通道。 First, using the illumination from the nasal cavity into the guidewire passage 3, so that the illuminating guidewire 3 reaches the position of the lacrimal sac and the nasal illuminating guidewire along the lacrimal implant dilator nasolacrimal duct 4, the extracted nasolacrimal dilator rod 42, nasolacrimal duct dilator 41 is placed inside the overtube nasolacrimal duct surgery as the working channel. 把预装在球囊导管2上的鼻泪管支架系统沿鼻泪道扩张器外套管41送入鼻泪管内,对球囊导管加压,实现支架的扩张。 The pre-installed on the balloon catheter 2 nasolacrimal duct stent system dilator along the nasolacrimal duct into the outer tube 41 nasolacrimal duct of a pressurized balloon catheter, to achieve expansion of the stent. 该植入工具可以采用304不锈钢、316L不锈钢或聚氨酯、聚碳酸酯等材料加工而成。 The implantation tool may be 304 stainless steel, 316L stainless steel or polyurethane, polycarbonate and other materials processing.

[0040] 本发明的植入系统还包括照明导丝,图3示出了该照明导丝3的结构,由螺旋弹簧33、透镜32和光缆31组成,透镜32固定于光缆31的照明端,螺旋弹簧33在照明端缠绕在光缆31的外部。 [0040] The implant system according to the present invention further comprises illuminating guidewire, FIG. 3 shows the structure of the illuminating guidewire 3 by the coil spring 33, the lens 32 and the optical fiber cable 31 composed of an illumination lens is fixed to the end 32 of the cable 31, coil spring 33 is wound around the outer end of the illumination fiber optic cable 31. 光缆31的与照明端相对的另一端和通用激光发射光源相连接,使得激光通过该光缆31传播,在透镜32的位置发射出来,形成一个激光亮点。 The other end of cable 31 opposite to the illumination side and the common source is connected to laser emission, such that the laser light propagating through the optical fiber cable 31, the emitted position of the lens 32, forming a bright spot laser. 将照明导丝3从鼻腔开口处入路,探入鼻泪道,利用该激光亮点观察判断照明导丝3是否位于鼻泪管指定位置。 The illuminating guidewire passage 3 opening into the nasal cavity, the nasal lacrimal duct into the probe, with the laser illumination is determined observation highlights guidewire nasolacrimal duct 3 is located at the specified location. 若照明导丝3到达目标位置,则关掉光源开关,并撤除激光发射光源。 If the lighting guidewire 3 reaches the target position, turn off the light switch, and the removal of laser emission source. 把照明导丝3从鼻泪管扩张器4的锥形端穿入,鼻泪管扩张器4顺着照明导丝3到达鼻泪管中指定位置。 3 penetrating the illumination guidewire from the tapered end of the dilator nasolacrimal duct 4, nasolacrimal duct 4 along the dilator illuminating guidewire nasolacrimal duct 3 reaches the specified position. 借助于该螺旋弹簧33,照明导丝3可以更为顺利地从鼻腔开口处进入。 By means of this coil spring 33, illuminating guidewire 3 can be more smoothly into the nasal cavity from the opening.

[0041] 如图4所示,鼻泪管扩张器4由鼻泪道扩张器外套管41和鼻泪道扩张器内杆42组成。 [0041] 4, the nasal dilator lacrimal nasolacrimal duct 4 from the outer tube 41 and the dilator nasolacrimal dilator 42 bar composition. 其中,图5示出该鼻泪道扩张器外套管41,由锥形端部411、主管412和手柄413构成。 Wherein, Figure 5 shows the nasolacrimal duct dilator overtube 41, constituted by a tapered end portion 411, director 412 and a handle 413. 图6示出该鼻泪道扩张器内杆42,由锥形扩张尖端421、主管422和手柄423构成。 Figure 6 shows the expansion of the nasolacrimal duct rod 42, the tip of the conical expander 421, supervisor 422 and a handle 423. 鼻泪道扩张器内杆42至少部分容置于鼻泪道扩张器外套管41内并与之可拆卸地配合。 Nasolacrimal dilator stem 42 is at least partially housed dilator nasolacrimal duct and the outer sleeve 41 to releasably engage therewith. 鼻泪道扩张器外套管41的锥形端部411和鼻泪道扩张器内杆42的锥形扩张尖端421的锥度相同,其锥度优选为1:2-1:3。 Nasolacrimal duct dilator tapered end portion of the outer sleeve 41 of the same tip 421 of the rod 42 within the conical expander 411 and tapered dilator nasolacrimal duct, which taper is preferably 1: 2-1: 3. 鼻泪道扩张器外套管41的主管412的内径比鼻泪道扩张器内杆42的主管422的外径大0.03-0.2mm,优选为大0.05-0.1mm。 Nasolacrimal duct dilator inner diameter of the outer sleeve 42 in charge director 412 of the rod 41 than the inner dilator nasolacrimal duct outer diameter 0.03-0.2mm 422 is preferably large 0.05-0.1mm. 鼻泪道扩张器内杆42通过鼻泪道扩张器外套管41的手柄开口413a插入,从而与鼻泪道扩张器外套管41配合形成如图4所示的鼻泪管扩张器4。 Nasolacrimal dilator rod 42 by nasolacrimal duct dilator handle 41 of the overtube inserted into the opening 413a, so that the dilator nasolacrimal duct fitting 41 is formed as shown in FIG overtube nasolacrimal duct 4 shown in FIG. 4 dilator.

[0042] 下面详细描述根据本发明的植入系统的使用方法: [0042] The following detailed description of the use of the implant system according to the invention:

[0043] SI,将鼻泪道扩张器内杆42插入鼻泪道扩张器外套管41的手柄开口413a内配合形成鼻泪管扩张器4。 [0043] SI, the rod nasolacrimal dilator 42 is inserted into the nasal lacrimal duct dilator overtube handle 41 is formed with openings 413a nasal dilator lacrimal 4.

[0044] S2,将照明导丝3从鼻腔开口处入路,探入鼻泪道,直至达到泪囊位置。 [0044] S2, the illuminating guidewire passage 3 opening into the nasal cavity, the nasal lacrimal duct into the probe until it reaches the position of the lacrimal sac.

[0045] S3,将步骤SI的鼻泪管扩张器4沿着步骤S2的照明导丝3从鼻腔开口处伸入鼻泪道内。 [0045] S3, the step SI nasal dilator 4 along the lacrimal step S2 illuminating guidewire nasolacrimal duct 3 extends into the nasal cavity from the opening.

[0046] S4,将鼻泪道扩张器外套管41留置在鼻泪道内,撤出鼻泪道扩张器内杆42和照明导丝3。 [0046] S4, the nasal dilator lacrimal overtube 41 retained within the nasal lacrimal duct, the inner rod withdrawal nasolacrimal dilator 42 and the illuminating guidewire 3.

[0047] S5,将鼻泪管支架I预装到球囊导管2上。 [0047] S5, nasal lacrimal stent on a balloon catheter to pre I 2.

[0048] S6,将步骤S5的球囊导管2沿着鼻泪道扩张器外套管41送入鼻泪管内,然后借助于球囊21的充盈使得鼻泪管支架I由收缩状态转变为扩张状态而支撑于鼻泪道内。 [0048] S6, the step S5 of the balloon catheter 2 along the nasolacrimal duct dilator overtube into the nasolacrimal duct 41, then by means of the filling of the balloon 21 such that the nasal lacrimal stent I transition from the contracted state to an expanded state and supported within the nasal lacrimal duct.

[0049] 以上所述的,仅为本发明的较佳实施例,并非用以限定本发明的范围,本发明的上述实施例还可以做出各种变化。 [0049] The above are merely preferred embodiments of the present invention is not intended to limit the scope of the present invention, the above-described embodiments of the present invention, various modifications may be made. 即凡是依据本发明申请的权利要求书及说明书内容所作的简单、等效变化与修饰,皆落入本发明专利的权利要求保护范围。 I.e., all according to the present invention as claimed in the claims and specification disclosure content made by simple modifications and equivalent arrangements, the present invention are claimed in the patent falls within the scope of claims. 本发明未详尽描述的均为常规技术内容。 No detailed description of the present invention are conventional technical contents.

Claims (11)

1.一种可完全降解的网状的鼻泪管支架,其特征在于,所述鼻泪管支架(1)包括由生物可降解高分子材料形成的套筒状的具有孔隙的网状本体(11),所述网状本体(11)的表面上具有药物涂层;所述网状本体(11)由彼此相连的第一网状本体部分(114和第二网状本体部分(114组成;在压缩状态下,所述第一网状本体部分(114和所述第二网状本体部分(114具有相同的直径;在扩张状态下,所述第一网状本体部分(114的直径大于所述第二网状本体部分(116)的直径。 A mesh can be completely degraded nasal lacrimal stent, wherein said stent nasolacrimal duct (1) comprises a biodegradable polymeric material forming a sleeve-like mesh body having pores ( 11), having a drug coating on a surface of the mesh body (11); and the mesh body (11) a first mesh body portion (body portion 114 and a second web (114 joined to each other by the composition; in the compressed state, the first body portion mesh (114 mesh and said second body portion (114 have the same diameter; in an expanded state, the diameter of the body portion of the first web (greater than 114 said body portion diameter of the second web (116).
2.根据权利要求1所述的鼻泪管支架,其特征在于,所述网状本体(11)包括支撑环(111)和连接杆(112),所述支撑环(111)为周向延伸的封闭的正弦波状支撑环,所述连接杆(112)设置于相邻的支撑环(111)之间。 The nasal lacrimal stent according to claim 1, characterized in that the mesh body (11) comprises a support ring (111) and a connecting rod (112), the support ring (111) is a circumferentially extending sinusoidal closed support ring, the connecting rod (112) disposed between the adjacent support ring (111).
3.根据权利要求2所述的鼻泪管支架,其特征在于,所述支撑环(111)由重复的单元(111幻首尾相连形成,所述第一网状本体部分(11幻的单元(111幻的数目多于所述第二网状本体部分(11¾)的单元(111¾)的数目。 3. nasolacrimal duct 2, the stent body portion of said first web (11 magic unit according to claim, characterized in that the support ring (111) connected to form a repeating unit (magic 111 inclusive, ( the number 111 is greater than the second mesh phantom body portion (11¾) unit (111¾) a.
4.根据权利要求3所述的鼻泪管支架,其特征在于,所述单元(1114为卩形单元,所述第一网状本体部分(11^0的^形单元的数目比所述第二网状本体部分(116)的7形单元的数目多2-3个。 The nasal lacrimal stent according to claim 3, wherein said unit (1114 Jie-shaped units, the number of the first mesh body portion (11 ^ 0 ^ shaped units than the first 7 number of shaped units of two mesh body portion (116) of the plurality 2-3.
5.根据权利要求1所述的鼻泪管支架,其特征在于,所述网状本体(11)的外表面上具有抗炎药物或抗粘连药物。 The nasal lacrimal stent according to claim 1, characterized in that the mesh body (11) having an outer surface of an anti-inflammatory drug or an anti-blocking drugs.
6.一种植入系统,其特征在于,所述植入系统包括根据上述权利要求中任一项所述的鼻泪管支架(1)。 An implant system, wherein the implant system comprising a nasal lacrimal stent (1) as claimed in any one preceding claim.
7.根据权利要求6所述的植入系统,其特征在于,所述植入系统还包括用于预装所述鼻泪管支架(1)的球囊导管(2),所述球囊导管(2)包括球囊(21),所述球囊(21)由第一球囊部分(214和第二球囊部分(214组成;在压缩状态下,所述第一球囊部分(214与所述第一网状本体部分(114对齐,所述第二球囊部分(214与所述第二网状本体部分(114对齐;在扩张状态下,所述第一球囊部分(214的直径大于所述第二球囊部分(216)的直径。 The implant system according to claim 6, wherein the implant further comprises a balloon catheter system (2) for the pre-loaded stent nasolacrimal duct (1), the balloon catheter (2) comprises a balloon (21), the balloon (21) by a first portion of the balloon (214 and second balloon portions (214 composition; in a compressed state, the first balloon portion (214 the first mesh body portion (114 aligned portion of the second balloon (214 mesh with said second body portion (114 aligned; in an expanded state, the diameter of the first balloon portion (214 the diameter of the balloon is greater than a second portion (216).
8.根据权利要求7所述的植入系统,其特征在于,在扩张状态下,所述球囊(21)内充盈有造影剂。 8. The implant system of claim 7, wherein, in an expanded state, the balloon has a radiopaque material in the filling (21).
9.根据权利要求6所述的植入系统,其特征在于,所述植入系统还包括鼻泪管扩张器(4),所述鼻泪管扩张器(4)由鼻泪道扩张器外套管(41)和鼻泪道扩张器内杆(42)组成,所述鼻泪道扩张器内杆(42)至少部分容置于所述鼻泪道扩张器外套管(41)内并与之可拆卸地配合。 9. The implant system according to claim 6, characterized in that the implant system further comprises a dilator nasolacrimal duct (4), said dilator nasolacrimal duct (4) by the nasolacrimal duct dilator coat tube (41) and the nasolacrimal duct dilatation rod (42), with said nasal dilator lacrimal rod (42) housed at least partially within the lacrimal nasal dilator overtube (41) and with removably mate.
10.根据权利要求9所述的植入系统,其特征在于,所述植入系统还包括照明导丝(3),所述鼻泪管扩张器(4)沿着所述照明导丝(3)延伸。 10. The implant system according to claim 9, wherein said illuminating guidewire implant (3), said dilator nasolacrimal duct (4) along said illumination system further comprises a guidewire (3 )extend.
11.根据权利要求10所述的植入系统,其特征在于,所述照明导丝(3)由螺旋弹簧(33)、透镜(32)和光缆(31)组成,所述透镜(32)固定于所述光缆(31)的照明端,所述螺旋弹簧(33)在所述照明端缠绕在所述光缆(33)的外部。 11. The implant system of claim 10, wherein said illuminating guidewire (3) by a coil spring (33), a lens (32) and the cable (31) consisting of the lens (32) is fixed to said cable (31) of the lighting end of the coil spring (33) wound around the outside of the end of the illumination fiber optic cable (33).
CN 201410521759 2014-09-30 2014-09-30 Completely-degradable net-shaped nasolacrimal stent and implantation system thereof CN104398329A (en)

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CN104814819A (en) * 2015-04-08 2015-08-05 朱宏伟 Biological naso-lacrymal duct support device
CN106955175A (en) * 2017-03-28 2017-07-18 艾拉·梁 Medical support
CN107669379A (en) * 2017-11-08 2018-02-09 柏文有限责任公司 Medical stent

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US20070038283A1 (en) * 2004-02-06 2007-02-15 Mustapha Jihad A Ostial stent and balloon
WO2006127824A1 (en) * 2005-05-23 2006-11-30 Incept Llc Apparatus and methods for delivering a stent into an ostium
CN201303997Y (en) * 2008-11-14 2009-09-09 肖满意 Infundibuliform nasolacrimal duct stent
CN103815986A (en) * 2014-02-27 2014-05-28 曾晨光 Artificial nasolacrimal duct
CN204246279U (en) * 2014-09-30 2015-04-08 浦易(上海)生物技术有限公司 Netted nasolacrimal duct stent capable of being completely degraded and implanting system for nasolacrimal duct stent

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104814819A (en) * 2015-04-08 2015-08-05 朱宏伟 Biological naso-lacrymal duct support device
CN106955175A (en) * 2017-03-28 2017-07-18 艾拉·梁 Medical support
CN107669379A (en) * 2017-11-08 2018-02-09 柏文有限责任公司 Medical stent

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