CN101106948A - 具有显微多孔性表面的可植入微线圈 - Google Patents

具有显微多孔性表面的可植入微线圈 Download PDF

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CN101106948A
CN101106948A CNA2006800030091A CN200680003009A CN101106948A CN 101106948 A CN101106948 A CN 101106948A CN A2006800030091 A CNA2006800030091 A CN A2006800030091A CN 200680003009 A CN200680003009 A CN 200680003009A CN 101106948 A CN101106948 A CN 101106948A
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vessel occlusion
poly
copolymer
little coil
lactide
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M·汉森
R·A·斯特恩
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Micrus Endovascular LLC
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Micrus Corp
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12181—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
    • A61B17/1219—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices expandable in contact with liquids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/74—Synthetic polymeric materials
    • A61K31/765—Polymers containing oxygen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/1767—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from invertebrates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/39—Connective tissue peptides, e.g. collagen, elastin, laminin, fibronectin, vitronectin, cold insoluble globulin [CIG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time

Abstract

用于患者脉管系统的治疗处理的脉管闭塞微线圈(10)，包括其中具有多个空隙或孔(18)的表面，和分布在所述多个空隙或孔(18)中的治疗性或生物活性材料。当微线圈(10)被导入患者脉管系统中时，所述多个空隙或孔(18)中的治疗性或生物活性材料产生作用以加速患者脉管系统中的愈合过程。

Description

具有显微多孔性表面的可植入微线圈
相关申请的交叉参考
[0001]本申请基于2005年1月26日提交的临时专利申请序列号60/647,516。
发明背景
[0002]已经开发出了可植入动脉瘤的微线圈(microcoil)，作为通过阻断脉动血流进入生长动脉瘤(promoting aneurysm)的中心而促进愈合的工具。这种器械在治疗脑动脉瘤中和在发现这种畸形时作为治疗和预防中风的方法，已经非常成功。
[0003]已知另一栓塞线圈(embolic coil)，其包括末端粗糙、有纹理的表面，其具有袋子，直径约0.125至50微米，深度约0.25至20微米，以便提供改进的血小板粘附作用和促进凝血。用于治疗动脉瘤颈部(neck of an aneurysm)的另一类可除去阻塞系统包括有孔的网孔部分，使得血液能够流过该网孔部分。尽管这些栓塞器械具有能够促进凝血或使得血液流过器械的空隙或孔，仍然期望提供能够进一步促进患者脉管系统愈合的栓塞器械。
[0004]已知一种脉管闭塞线圈，其具有增强的治疗性线状结构，所述结构可以由治疗性或生物活性材料形成或可以掺入治疗性或生物活性材料，如聚乙醇酸(PGA)或D，L-乳酸/乙醇酸共聚物(PGLA)或其它的治疗性材料。已知另一栓塞器械，其包括由疏水性、大孔、聚合的水凝胶泡沫材料形成的栓塞元件。
[0005]尽管动脉瘤的微线圈治疗在改善患有这种畸形的患者的预后恢复方面是高效的，然而据认为，如果新的且有效的微线圈治疗方法能够用于在放置微线圈时增强愈合过程，则该方法的成功率会提高。
本发明解决了现有技术器械中的这些和其它局限性。
发明概述
[0006]本发明论述了微线圈和其它可植入器械，应用多种蚀刻方法中的一种或多种——其可以包括等离子体蚀刻、光刻和化学蚀刻——以在微线圈表面产生微小空隙，其形状复杂并且适于通过压力、熔化或沉积而将多种治疗剂、治疗性材料和治疗性塑性剂(plastic agent)中的一种或多种接纳入表面，所述治疗剂、治疗性材料和治疗性塑性剂能够在线圈处于适当位置时起加速愈合过程的作用。在此时，被认为适于沉积在通过所述方法产生的空隙中的药剂，包括治疗药物和药剂如PGA或PGLA等等，它们能够作为愈合过程的促进剂起作用。
[0007]因此，本发明提供了用于患者脉管系统治疗处理的脉管闭塞微线圈，包括这样的脉管闭塞微线圈，其具有至少一个其中具有限定多个空隙或孔的表面的部分，和分布在所述多个空隙或孔内的治疗性或生物活性材料。本发明也提供了闭塞患者脉管系统的方法，包括步骤：提供脉管闭塞微线圈，其具有至少一个其中具有限定多个空隙的表面的部分，和分布在所述多个空隙内的治疗性/生物活性材料；和将该脉管闭塞微线圈引入患者的脉管系统，从而治疗性/生物活性材料可以起到加速患者脉管系统中的愈合过程的作用。本发明也提供了通过这样的微线圈将治疗剂或治疗材料输送到患者脉管系统的方法，所述微线圈具有至少一个携带具有多个空隙或孔的表面的部分；和提供了通过控制微线圈表面的孔隙率来控制治疗剂或治疗材料输送的方法。本发明也提供了通过微线圈将水凝胶输送给患者脉管系统的方法，所述微线圈具有至少一个携带具有多个空隙或孔的表面的部分，所述多个空隙或孔携带水凝胶。本发明也提供了应用多种蚀刻方法中的一种或多种在微线圈表面形成空隙的方法，所述蚀刻方法可以包括等离子体蚀刻和溅射。
[0008]治疗剂或治疗材料可以是治疗药物或治疗性塑性剂，它们能够在线圈处于合适位置时起到加速愈合过程的作用，在目前优选的方面，治疗剂或治疗材料可以是聚乙醇酸或D，L-乳酸/乙醇酸共聚物、和/或治疗药物。更广义地，治疗材料可以是丝、胶原、弹性蛋白、聚乙醇酸、聚乳酸、D，L-乳酸/乙醇酸共聚物、聚L-丙交酯、L-丙交酯/D，L-丙交酯共聚物、L-丙交酯/乙交酯共聚物、乙交酯/亚丙基碳酸酯(trimethylene carbonate)共聚物、聚环氧乙烷、聚二烷酮、聚己内酯、hylauric acid、聚羟基丁酯、聚磷腈、D，L-丙交酯/己内酯共聚物、乙交酯/己内酯共聚物、聚乙烯醇、其聚酐、其聚原酸酯、其聚磷酸酯、其聚氨基酸、其聚羟基丁酯、其共聚物、其复合物或其组合。治疗材料也可以是乙烯-辛烯共聚物、聚丙烯、聚乙烯、聚丙烯酸酯、聚丙烯酰胺、聚甲基丙烯酸羟乙酯、聚氨酯、聚硅氧烷、其共聚物、其复合物或其组合。
[0009]从下面对优选实施方式的详细描述结合通过举例方式说明本发明的附图，本发明的其它特征和优势将变得更为显而易见。
附图简述
[0010]图1是根据本发明的微线圈的一部分的透视图。
[0011]图2是图1的2-2处的截面图。
[0012]图3示出了根据本发明形成的螺旋多股微线圈的一部分。
[0013]图4示出了根据本发明形成的螺旋单股微线圈的一部分。
优选实施方式的详述
[0014]如附图所示，本发明体现为脉管闭塞微线圈，所述脉管闭塞微线圈具有至少一个具有其中限定多个空隙或孔的表面的部分，和在所述空隙或孔中的治疗性或生物活性材料，所述附图提供用于说明目的而非限制性目的。在图1示例的目前优选的方面中，脉管闭塞微线圈例如可以由弹性材料和/或超弹性材料如镍钛合金的一个或多个柔性线股(strand)12形成。镍钛合金一般被热处理，这样，在适于通过导管引入机体的温度下，该合金具有高度的柔韧性。通过选择这样的材料用于微线圈和类似物，由微电缆(micro-cable)形成的器械可以相对容易地被放置入合适的体腔，在放置之后，器械将呈现出经设计使对该器械期望的治疗目的最优化的形状。
[0015]如图2所说明，脉管闭塞微线圈也可以包括中央的、轴向布置的不透射线的丝14，例如，它可以由铂或金制成，或其它相似的合适的不透射线的金属制成，目的是在脉管手术期间为由脉管闭塞微线圈制成的器械的展开构造提供不透射线的标志。
[0016]本发明的一个有利应用是由脉管闭塞微线圈形成的脉管闭塞器械，用于插入动脉瘤和其它脉管缺陷，目的是闭塞向动脉瘤的流动。图3说明了脉管闭塞微线圈10的螺旋状缠绕线圈16的一部分，其被形成以安装在微导管内，用于插入到将实施治疗过程的区域中。图4说明了脉管闭塞微线圈10’的螺旋状缠绕线圈16’的一部分，其被形成以安装在微导管内，用于插入到将实施治疗过程的区域中。虽然示例了螺旋状线圈，但是应该理解，可以由本发明的脉管闭塞微线圈形成许多其它形状。
[0017]如图1和4中所示例，脉管闭塞微线圈包括至少一个在微线圈表面具有限定多个微小空隙或孔18的表面的部分，其形状可以是复杂的。应用各种溅射和蚀刻方法中的一种或多种，空隙或孔可以在微线圈表面形成，所述方法可以包括，例如，等离子体蚀刻、光刻和化学蚀刻，和它们的任何组合或多种组合。当与沉积、挤压或熔化愈合促进治疗性和/或生物活性材料进入表面的能力相结合时，在可植入器械表面产生微小空隙或孔的其它方法可以是有效的。
[0018]空隙或孔被有利地形成，以便接纳和保留多种治疗性和/或生物活性剂，一旦线圈处于适当位置时，它们能够起到加速愈合过程的作用。通过压力、熔化或沉积或类似方法，药剂可以被沉积在空隙或孔中。在此时，被认为适于沉积在本方法产生的空隙或孔中的药剂包括聚乙醇酸(PGA)和D，L-乳酸/乙醇酸共聚物(PGLA)，其可以作为愈合过程的促进剂起作用。可以沉积在空隙或孔中的其它治疗性和/或生物活性剂包括聚乙醇酸或聚D，L-丙交酯(PLA)、D，L-丙交酯/乙交酯共聚物(PLA/PGA)、聚L-丙交酯(PLLA)、L-丙交酯/D，L-丙交酯共聚物(PLLA/PLA)、L-丙交酯/乙交酯共聚物(PLLA/PGA)、乙交酯/亚丙基碳酸酯共聚物(PGA/PTMC)、聚环氧乙烷(PEO)、聚二烷酮(PDS)、聚己内酯(PCL)、hylauric acid、聚羟基丁酯(PHBT)、聚磷腈、D，L-丙交酯/己内酯共聚物(PLA/PCL)、乙交酯/己内酯共聚物(PGA/PCL)、聚乙烯醇(PVA)、这些材料的聚酐(PAN)、聚原酸酯、聚磷酸酯、聚氨基酸、聚羟基丁酯、共聚物以及它们的复合物和组合；非金属纤维材料如丝、胶原、弹性蛋白或其它连接蛋白；塑性或其它聚合物如乙烯-辛烯共聚物、聚丙烯、聚乙烯、聚丙烯酸酯、聚丙烯酰胺、聚甲基丙烯酸羟乙酯、聚氨酯、聚硅氧烷及它们的共聚物。治疗性和/或生物活性非金属纤维材料可以是可生物吸收的或不可吸收的。治疗性和/或生物活性非金属纤维材料也可以用于吸收和释放一种或多种治疗剂。
[0019]从前述看来，显然的是，虽然示例和描述了本发明的特定形式，但可以对其进行各种修改，而不背离本发明的精神和范围。因此，不意图于使本发明受到限制，除了如所附权利要求限制外。

Claims (16)

1.用于患者脉管系统的治疗处理的脉管闭塞微线圈，包括：
脉管闭塞微线圈，其包括至少一个部分，所述至少一个部分具有其中限定多个空隙的表面；和
分布在所述多个空隙中的治疗性/生物活性材料。
2.权利要求1的脉管闭塞微线圈，其中所述治疗性材料是塑性剂，一旦所述线圈位于合适的位置时，所述塑性剂能够起到加速愈合过程的作用。
3.权利要求1的脉管闭塞微线圈，其中所述治疗性材料选自聚乙醇酸和D，L-乳酸/乙醇酸共聚物。
4.权利要求1的脉管闭塞微线圈，其中所述治疗性材料选自丝、胶原、弹性蛋白、聚乙醇酸、聚乳酸、D，L-乳酸/乙醇酸共聚物、聚L-丙交酯、L-丙交酯/D，L-丙交酯共聚物、L-丙交酯/乙交酯共聚物、乙交酯/亚丙基碳酸酯共聚物、聚环氧乙烷、聚二烷酮、聚己内酯、hylauricacid、聚羟基丁酯、聚磷腈、D，L-丙交酯/己内酯共聚物、乙交酯/己内酯共聚物、聚乙烯醇、其聚酐、其聚原酸酯、其聚磷酸酯、其聚氨基酸、其聚羟基丁酯、其共聚物、其复合物和其组合。
5.权利要求1的脉管闭塞微线圈，其中所述治疗性材料选自乙烯-辛烯共聚物、聚丙烯、聚乙烯、聚丙烯酸酯、聚丙烯酰胺、聚甲基丙烯酸羟乙酯、聚氨酯、聚硅氧烷、其共聚物、其复合物和其组合。
6.权利要求1的脉管闭塞微线圈，其中所述治疗性材料是治疗药物。
7.闭塞患者脉管的方法，包括：
提供脉管闭塞微线圈，所述脉管闭塞微线圈包括至少一个具有其中限定多个空隙的表面的部分，和分布在所述多个空隙内的治疗性/生物活性材料；和
将所述脉管闭塞微线圈引入患者的脉管系统，从而所述治疗性/生物活性材料可以起到加速所述患者脉管系统中的愈合过程的作用。
8.权利要求7的方法，其中所述治疗性材料是塑性剂，一旦所述线圈位于合适位置时，它能够起到加速愈合过程的作用。
9.权利要求7的方法，其中所述治疗性材料选自聚乙醇酸和D，L-乳酸/乙醇酸共聚物。
10.权利要求7的方法，其中所述治疗性材料选自丝、胶原、弹性蛋白、聚乙醇酸、聚乳酸、D，L-乳酸/乙醇酸共聚物、聚L-丙交酯、L-丙交酯/D，L-丙交酯共聚物、L-丙交酯/乙交酯共聚物、乙交酯/亚丙基碳酸酯共聚物、聚环氧乙烷、聚二烷酮、聚己内酯、hylauric acid、聚羟基丁酯、聚磷腈、D，L-丙交酯/己内酯共聚物、乙交酯/己内酯共聚物、聚乙烯醇、其聚酐、其聚原酸酯、其聚磷酸酯、其聚氨基酸、其聚羟基丁酯、其共聚物、其复合物和其组合。
11.权利要求7的方法，其中所述治疗性材料选自乙烯-辛烯共聚物、聚丙烯、聚乙烯、聚丙烯酸酯、聚丙烯酰胺、聚甲基丙烯酸羟乙酯、聚氨酯、聚硅氧烷、其共聚物、其复合物和其组合。
12.向患者脉管系统输送治疗药物的方法，包括：
提供脉管闭塞微线圈，所述脉管闭塞微线圈包括至少一个具有其中限定多个空隙的表面的部分，和分布在所述多个空隙内的治疗药物；和
将所述脉管闭塞微线圈引入患者的脉管系统。
13.权利要求12的方法，还包括通过控制其中限定多个空隙的所述表面的孔隙率而控制所述治疗药物输送的步骤。
14.向患者脉管系统输送水凝胶的方法，包括：
提供脉管闭塞微线圈，所述脉管闭塞微线圈包括至少一个具有其中限定多个空隙的表面的部分；和分布在所述多个空隙内的水凝胶，和
将所述脉管闭塞微线圈引入患者的脉管系统。
15.形成脉管闭塞微线圈的方法，所述脉管闭塞微线圈包括至少一个具有其中限定多个空隙的表面的部分，所述方法包括：
提供脉管闭塞微线圈；
通过选自溅射和蚀刻及其组合的方法，在所述脉管闭塞微线圈表面上形成多个空隙。
16.权利要求15的方法，其中蚀刻包括选自下列的蚀刻方法：等离子体蚀刻、光刻和化学蚀刻及其它们的组合。
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