WO2015101308A1 - 一种弹簧圈及其制备方法 - Google Patents

一种弹簧圈及其制备方法 Download PDF

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WO2015101308A1
WO2015101308A1 PCT/CN2014/095745 CN2014095745W WO2015101308A1 WO 2015101308 A1 WO2015101308 A1 WO 2015101308A1 CN 2014095745 W CN2014095745 W CN 2014095745W WO 2015101308 A1 WO2015101308 A1 WO 2015101308A1
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coil
inches
wire
volume
diameter
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PCT/CN2014/095745
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English (en)
French (fr)
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刘建民
谢志永
黄清海
郭远益
贾国庆
金巧蓉
陈冰
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微创神通医疗科技（上海）有限公司
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Publication of WO2015101308A1 publication Critical patent/WO2015101308A1/zh

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    • 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
    • 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
    • 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
    • A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
    • 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

Definitions

  • the invention relates to the field of medical devices.
  • the present invention relates to a coil and a method of making same.
  • endovascular intervention has become a preferred method for the treatment of intracranial aneurysms because it has a lower risk than surgical treatment and has replaced surgical aneurysm clipping surgery.
  • the coils of embolization aneurysms are mainly divided into two types: one is a bare metal coil, such as a Boston Scientific GDC coil and a Microvention microPlex coil; the other is a bio-modified coil, such as Codman's Cerecyte spring. Circle, Microvention Hydrogel hydrogel coils and Boston Scientific's Matrix coils.
  • Cipheral Patent Application No. CN201120007508.6 discloses a coil spring product for embolization capable of rapidly generating a thrombus.
  • the surface of the coil has a rapid thrombogenic drug, such as protamine sulfate, and the controlled release of the drug is achieved by a carrier which is a degradable medical polymer material.
  • a carrier which is a degradable medical polymer material.
  • the coil When the coil is implanted into the aneurysm, it will rapidly produce a thrombus, completely embolize the aneurysm, and the degradation product (oligomer) of the biodegradable carrier in the human body will promote the transformation of the thrombus into fibroblast tissue, which can accelerate the aneurysm. Completely healed.
  • a bioabsorbable polymer implant and a method of using the same to create a plug are disclosed in U.S. Patent No. 8,388,643 B2.
  • the patent incorporates a novel embolic agent (bioabsorbable polymer material) into an electrolytically removed coil (GDC) to improve intravascular interventional treatment of intracranial arteries. Long-term treatment effect in the tumor.
  • the invention aims to solve the problems of long-term safety and occupancy effect of the existing spring coil after being implanted into the human body, and provides a spring coil and a preparation method thereof.
  • the invention relates to a coil comprising a first coil and a second coil, the second coil being wound on the outside of the first coil, wherein one coil is a degradable material and another coil
  • the volume of the degradable material is from 75% to 95% by volume of the coil.
  • the first coil is made of wire strand having a diameter D 1 is 0.00001 inches to 0.008 inches, preferably from 0.0008 inches to 0.004 inches.
  • the second coil is made of a wire chain having a diameter D 2 of from 0.00001 inches to 0.008 inches, preferably from 0.0008 inches to 0.002 inches.
  • the degradable material is selected from the group consisting of polylactic acid (PLA), polyglycolic acid (PGA), poly-L-lactic acid (PLLA), polyglycolic acid/polylactic acid copolymer (PLGA), poly(propyl acrylate) (PCL), etc., preferably It is a polyglycolic acid/polylactic acid copolymer (PLGA).
  • the radiopaque material comprises an alloy of one or more of a platinum group metal, tantalum, tungsten, rhenium, gold or silver.
  • the radiopaque material is preferably a platinum/tungsten alloy. These metals have significant radiopacity and are adjusted for alloy composition to achieve proper elasticity and stiffness.
  • the spring ring has a degradation time of 2 to 4 months, preferably 3 months.
  • the invention also relates to a method for preparing a coil, characterized in that it comprises the following steps:
  • first wire chain and a second wire chain wherein one of the wire chains is a degradable material, the other of the wire chains is a radiopaque material, and the volume of the degradable material accounts for 75% of the volume of the coil % ⁇ 95%;
  • the wound first coil and the second coil are shaped on the mold in accordance with a predetermined shape.
  • the winding direction of the first coil is opposite to the winding direction of the second coil.
  • the reverse winding method can avoid the first coil and the second coil being embedded in the manufacturing process, so that the manufacturing process is smoother.
  • the "winding angle" of the present invention is defined as the angle formed by the wire chain of the first or second coil and the axial direction of the metal mandrel.
  • the coil of the invention is composed of metal and degradable polymer material, and can accelerate the fibrosis of the thrombus in the aneurysm after implantation, and with the degradation of the biological material, the fibrous tissue in the tumor shrinks continuously, so that the aneurysm is continuously reduced, thereby reducing
  • the space-occupying effect of the coils and the higher percentage of the volume of degradable material bring about more significant effects in solving the problem of occupancy and long-term safety.
  • 1-4 are longitudinal cross-sectional views of a coil of various embodiments of the present invention.
  • Figure 5 is a schematic view showing the degradation of the coil after implantation of the aneurysm
  • Fig. 6 is a schematic view showing the therapeutic effect of a coil inserted into an aneurysm.
  • the second coil 1 is wound around the outside of the first coil 2 as shown in FIG.
  • the second coil 1 is composed of a degradable material polyglycolic acid/polylactic acid copolymer (PLGA) having a diameter D 1 of 0.003"(inch);
  • the first coil 2 is made of a biocompatible, developable platinum/ Made of tungsten alloy wire, the diameter D 2 of the wire chain is 0.001".
  • the volume of the second coil 1 as a percentage of the entire coil volume is 83.3%.
  • the manufacturing method is as follows: (1) winding the first coil 2 on a metal mandrel having a diameter of 0.0001" to 0.1", preferably 0.005", the coil is tightly wound, the pitch is 0.001", and the winding angle is 85°; 2) The second coil 1 is reversely wound on the outside of the first coil 2, the coil is tightly wound, the pitch is 0.003", the winding angle is 85°; (3) the first coil 2 and the second coil to be wound are wound 2
  • the shaping process is performed on the mold according to the preset shape; (4) the biomaterial after the aneurysm is implanted, that is, PLGA, begins to degrade, as shown in FIG.
  • the degradation time is 3 months; 5) thrombus fibrosis in the aneurysm after implantation, and with the degradation of biomaterials, the contraction of intratumoral fibrous tissue can also reduce the aneurysm and reduce the space-occupying effect of the coil.
  • the effect after treatment is shown in Figure 6. It can be shown that the aneurysm can be reduced to about 16.7% of the original volume.
  • the second coil is wound around the outside of the first coil as shown in FIG.
  • the first coil is composed of a degradable material polylactic acid (PLA) having a diameter of 0.004"; the second coil is made of a biocompatible, developable gold wire having a diameter of 0.0008".
  • the first coil volume accounts for 75% of the entire coil volume.
  • the manufacturing method is as follows: (1) winding the first coil on a metal mandrel having a diameter of 0.003", the coil is tightly wound, the pitch is 0.004", the winding angle is 75°; (2) the outer side of the first coil is reversed.
  • the implantation and degradation process of the coil is the same as in the first embodiment, and finally the aneurysm can be reduced to about 25% of the original volume.
  • the second coil is wound around the outside of the first coil.
  • the second coil volume accounts for the entire coil volume The percentage is 95%.
  • (1) the inner layer coil is the first coil, and the biocompatible platinum wire is used.
  • the diameter of the platinum wire is 0.002′′, the coil is sparsely wound, the spacing is 0.01′′, and the winding angle is 90°;
  • the outer coil is a second coil, and the degradable material polyglycolic acid/polylactic acid copolymer (PLGA) filament is used.
  • the diameter of the degradable material filament chain is 0.0008′′, the coil is tightly wound, and the pitch is 0.0008′′, and the winding angle is It is 60° as shown in Figure 3.
  • the implantation and degradation process of the coil is the same as in the first embodiment, and finally the aneurysm can be reduced to about 5% of the original volume.
  • the second coil is wound around the outside of the first coil.
  • the inner layer coil is the first coil, and the degradable material polyglycolic acid/polylactic acid copolymer (PLGA) filament is used.
  • the diameter of the degradable material filament chain is 0.008", and the coil is tightly wound with a pitch of 0.008".
  • the winding angle is 90°, the first coil volume accounts for 93.5% of the entire coil volume;
  • the outer coil is the second coil, and the biocompatible platinum/tungsten alloy wire is used, and the platinum is selected.
  • the wire has a diameter of 0.001", the coil is sparsely wound, the pitch is 0.001", and the winding angle is 60, as shown in FIG.
  • the implantation and degradation process of the coil is the same as in the first embodiment, and finally the aneurysm can be reduced to about 6.5% of the original volume.

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Abstract

一种弹簧圈，包括第一线圈（2）和第二线圈（1），所述第二线圈（1）绕在所述第一线圈（2）的外侧面。第一线圈（2）和第二线圈（1）中的其中一种线圈为可降解材料，另一种线圈为不透射线材料。所述可降解材料的体积占弹簧圈体积的百分比为75%至95%。

Description

一种弹簧圈及其制备方法 技术领域
本发明涉及医疗器械领域。具体而言，本发明涉及一种弹簧圈及其制备方法。
背景技术
脑动脉瘤或颅内动脉瘤，严重影响着人们的健康。随着影像技术的进步和血管内生物材料的发展，血管内介入治疗因其比外科手术治疗的风险更低，已取代外科动脉瘤夹闭手术成为治疗颅内动脉瘤的首选方法。
介入治疗颅内动脉瘤的方法很多，主要有在载瘤动脉上开展的血管重建密网支架术和动脉瘤腔内的栓塞术。而在动脉瘤腔内栓塞弹簧圈是目前治疗动脉瘤的主要方法。目前栓塞动脉瘤的弹簧圈主要分为两种：一种为金属裸弹簧圈，如Boston Scientific的GDC弹簧圈和Microvention的MicroPlex弹簧圈；另一种是生物修饰弹簧圈，如Codman公司的Cerecyte弹簧圈、Microvention的Hydrogel水凝胶弹簧圈和Boston Scientific的Matrix弹簧圈。
中国专利申请No.CN201120007508.6公开了一种能够快速产生血栓的栓塞用弹簧圈产品。这种弹簧圈表面带有快速致血栓药物，例如硫酸鱼精蛋白，药物的控制释放是通过载体实现的，载体为一种可降解的医用高分子材料。这种弹簧圈植入动脉瘤后会快速产生血栓，将动脉瘤完全栓塞，而生物可降解载体在人体内的降解产物(低聚体)会促进血栓转化为纤维细胞组织，可加速动脉瘤的完全愈合。
美国专利No.US8,388,643B2公开了生物可吸收聚合物植入物及使用其产生栓塞的方法。具体而言，该专利是将一种新型栓塞剂(生物可吸收聚合物材料)掺入电解脱的弹簧圈(GDC)中，从而改善血管内介入治疗颅内动脉 瘤中的长期治疗效果。
虽然目前的弹簧圈在提高填塞致密度、降低动脉瘤复发率等方面有很大的进步，但弹簧圈在瘤腔内的占位效应一直不能解决。
发明内容
本发明旨在解决现有弹簧圈植入人体后的长期安全性及占位效应等问题，并为此提供一种弹簧圈及其制备方法。
本发明涉及一种弹簧圈，其特征在于，包括第一线圈和第二线圈，所述第二线圈绕在所述第一线圈的外侧，其中一种线圈为可降解材料，以及另一种线圈为不透射线材料，所述可降解材料的体积占所述弹簧圈体积的百分比为75％～95％。
所述第一线圈由直径D1为0.00001英寸～0.008英寸，优选为0.0008英寸～0.004英寸的丝链制成。
所述第二线圈由直径D2为0.00001英寸～0.008英寸，优选为0.0008英寸～0.002英寸的丝链制成。
所述可降解材料选自聚乳酸(PLA)、聚羟基乙酸(PGA)、聚左旋乳酸(PLLA)、聚羟基乙酸/聚乳酸共聚物(PLGA)、聚已酸丙酯(PCL)等，优选的是聚羟基乙酸/聚乳酸共聚物(PLGA)。
所述不透射线材料包括铂族金属、铼、钨、钽、金或银中的一种或几种的合金。所述不透射线材料优选为铂/钨合金。这些金属具有显着的射线不透性，并通过调整合金成分以达到适当的弹性和刚度。
所述弹簧圈的降解时间为2～4个月，优选为3个月。
本发明还涉及一种弹簧圈的制备方法，其特征在于，包括下列步骤：
提供第一丝链和第二丝链，其中一种丝链为可降解材料，另一种丝链为不透射线材料，且所述可降解材料的体积占所述弹簧圈体积的百分比为75％～95％；
将第一丝链绕在芯棒上制成第一线圈；
将第二丝链绕在第一线圈外侧制成第二线圈；以及
将绕制好的第一线圈和第二线圈按照预先设定好的形状在模具上进行定型处理。
根据本发明，所述第一线圈的绕制方向与所述第二线圈的绕制方向相反。采用反向绕制的方式，可以避免在制作过程中第一线圈与第二线圈相嵌，使制作工艺更顺畅。
本发明的“绕制角度”定义为第一或第二线圈的丝链与金属芯棒的轴向方向形成的角度。
本发明的弹簧圈由金属和可降解高分子材料组成，植入后能加速动脉瘤内血栓的纤维化，且随着生物材料的降解，瘤内纤维组织不断收缩使动脉瘤不断缩小，从而减轻弹簧圈的占位效应，更高的可降解材料体积百分比，对于解决占位效应和长期安全性问题带来更显著的效果。
附图说明
图1-4是本发明各种实施例弹簧圈的纵截面视图；
图5是弹簧圈植入动脉瘤后的降解示意图；以及
图6是弹簧圈植入动脉瘤的治疗效果示意图。
具体实施方式
为了进一步理解本发明，下面将结合实施例对本发明的优选方案进行描述。这些描述只是举例说明本发明弹簧圈及其制备方法的特征和优点，而非限制本发明的保护范围。
实施例1
第二线圈1绕在第一线圈2的外侧，如图1所示。第二线圈1由可降 解材料聚羟基乙酸/聚乳酸共聚物(PLGA)组成，丝链的直径D1是0.003″(英寸)；第一线圈2采用生物相容性好、可显影的铂/钨合金丝制成，丝链的直径D2是0.001″。所述第二线圈1体积占整个弹簧圈体积的百分比为83.3％。
制作方法为：(1)在直径为0.0001″～0.1″，优选为0.005″的金属芯棒上绕制第一线圈2，线圈紧密绕制，间距为0.001″，绕制角度为85°；(2)在第一线圈2外侧反向绕制第二线圈1，线圈紧密绕制，间距为0.003″，绕制角度为85°；(3)将绕制好的第一线圈2和第二线圈2按照预先设定好的形状在模具上进行定型处理；(4)该弹簧圈植入动脉瘤后生物材料，即PLGA，开始降解，如图5所示，降解的时间为3个月；(5)植入后动脉瘤内的血栓纤维化，且随着生物材料的降解，瘤内纤维组织的收缩也可以缩小动脉瘤，并减轻弹簧圈的占位效应，治疗后的效果如图6所示，动脉瘤可缩小为原体积的16.7％左右。
实施例2
第二线圈绕在第一线圈的外侧，如图2所示。第一线圈由可降解材料聚乳酸(PLA)组成，丝链的直径是0.004″；第二线圈采用生物相容性好、可显影的金丝，金丝的直径为0.0008″。所述第一线圈体积占整个弹簧圈体积的百分比为75％。制作方法为：(1)在直径为0.003″的金属芯棒上绕制第一线圈，线圈紧密绕制，间距为0.004″，绕制角度为75°；(2)在第一线圈外侧反向绕制第二线圈，线圈紧密绕制，间距为0.0008″，绕制角度为75°；(3)将绕制好的第一线圈和第二线圈按照预先设定好的形状在模具上进行定型处理。该弹簧圈的植入及降解过程与实施例1相同，最终可使动脉瘤缩小为原体积的25％左右。
实施例3
第二线圈绕在第一线圈的外侧。所述第二线圈体积占整个弹簧圈体积 的百分比为95％。其中(1)内层线圈为第一线圈，采用生物相容性好的铂金丝，选用铂金丝的直径为0.002″，线圈稀疏绕制，间距为0.01″，绕制角度为90°；(2)外层线圈为第二线圈，采用可降解材料聚羟基乙酸/聚乳酸共聚物(PLGA)丝，可降解材料丝链的直径是0.0008″，线圈紧密绕制，间距为0.0008″，绕制角度为60°，如图3所示。该弹簧圈的植入及降解过程与实施例1相同，最终可使动脉瘤缩小为原体积的5％左右。
实施例4
第二线圈绕在第一线圈的外侧。其中(1)内层线圈为第一线圈，采用可降解材料聚羟基乙酸/聚乳酸共聚物(PLGA)丝，可降解材料丝链的直径是0.008″，线圈紧密绕制，间距为0.008″，绕制角度为90°，所述第一线圈体积占整个弹簧圈体积的百分比为93.5％；(2)外层线圈为第二线圈，采用生物相容性好的铂/钨合金丝，选用铂金丝的直径为0.001″，线圈稀疏绕制，间距为0.001″，绕制角度为60°，如图4所示。该弹簧圈的植入及降解过程与实施例1相同，最终可使动脉瘤缩小为原体积的6.5％左右。
以上实施例的说明只是用于帮助理解本发明的核心思想。应当指出，对于本领域的普通技术人员而言，在不脱离本发明原理的前提下，还可以对本发明的弹簧圈及其制备方法进行若干改进和修饰，但这些改进和修饰也落入本发明权利要求请求保护的范围内。

Claims (10)

  1. 一种弹簧圈，包括第一线圈和第二线圈，其特征在于，所述第二线圈绕在所述第一线圈的外侧，其中一种线圈为可降解材料，另一种线圈为不透射线材料，所述可降解材料的体积占所述弹簧圈体积的百分比为75％～95％。
  2. 如权利要求1所述的弹簧圈，其特征在于，所述第一线圈由直径D1为0.00001英寸～0.008英寸的丝链制成。
  3. 如权利要求2所述的弹簧圈，其特征在于，所述第一线圈由直径D1为0.0008英寸～0.004英寸的丝链制成。
  4. 如权利要求1所述的弹簧圈，其特征在于，所述第二线圈由直径D2为0.00001英寸～0.008英寸的丝链制成。
  5. 如权利要求4所述的弹簧圈，其特征在于，所述第二线圈由直径D2为0.0008英寸～0.002英寸的丝链制成。
  6. 如权利要求1-5任一项所述的弹簧圈，其特征在于，所述可降解材料选自聚乳酸、聚羟基乙酸、聚左旋乳酸、聚羟基乙酸/聚乳酸共聚物或聚已酸丙酯。
  7. 如权利要求1-5任一项所述的弹簧圈，其特征在于，所述不透射线材料选自铂族金属、铼、钨、钽、金或银中的一种或几种的合金。
  8. 如权利要求7所述的弹簧圈，其特征在于，所述不透射线材料为铂/钨合金。
  9. 如权利要求1-8中任一项所述的弹簧圈的制备方法，其特征在于，包括下列步骤：
    提供第一丝链和第二丝链，其中一种丝链为可降解材料，另一种丝链为不透射线材料，且所述可降解材料的体积占所述弹簧圈体积的百分比为75％～95％，
    将第一丝链绕在芯棒上制成第一线圈，
    将第二丝链绕在第一线圈外侧制成第二线圈，
    以及
    将绕制好的第一线圈和第二线圈按照预先设定好的形状在模具上进行定型处理。
  10. 如权利要求9所述的制备方法，其特征在于，所述第一线圈的绕制方向与所述第二线圈的绕制方向相反。
PCT/CN2014/095745 2013-12-31 2014-12-31 一种弹簧圈及其制备方法 WO2015101308A1 (zh)

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CN113303860B (zh) * 2020-12-31 2023-09-22 神遁医疗科技(上海)有限公司 一种栓塞物及其制备方法
CN112754583B (zh) * 2020-12-31 2022-04-15 微创神通医疗科技（上海）有限公司 弹簧圈及其制备方法
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