WO2018214384A1 - 一种封堵网篮及具有该网篮的封堵装置 - Google Patents

一种封堵网篮及具有该网篮的封堵装置 Download PDF

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Publication number
WO2018214384A1
WO2018214384A1 PCT/CN2017/105626 CN2017105626W WO2018214384A1 WO 2018214384 A1 WO2018214384 A1 WO 2018214384A1 CN 2017105626 W CN2017105626 W CN 2017105626W WO 2018214384 A1 WO2018214384 A1 WO 2018214384A1
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Prior art keywords
basket
polymer
shape memory
memory alloy
mandrel
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PCT/CN2017/105626
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English (en)
French (fr)
Inventor
郑忠伟
严航
黄云腾
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上海英诺伟医疗器械有限公司
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Publication of WO2018214384A1 publication Critical patent/WO2018214384A1/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
    • A61B17/12027—Type of occlusion
    • A61B17/12031—Type of occlusion complete occlusion
    • 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
    • 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
    • A61B17/12159—Solid plugs; being solid before insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A61B2017/00871—Material properties shape memory effect polymeric

Definitions

  • the invention relates to the technical field of medical instruments, in particular to a netting basket and a occlusion device having the same.
  • Ureteral calculi is one of the common diseases in urology.
  • Current treatments for ureteral stones include extracorporeal shock wave lithotripsy (ESWL), ureterolithotomy, and ureteroscopic lithotripsy.
  • Ureteroscopy lithotripsy is a small mirror with a diameter of about 3 mm. The ureter and bladder are inserted into the ureter, and the ureteral stones or kidney stones are crushed and taken out. It utilizes the natural urinary tract of the human body and does not make any incisions in the body. It is a pure urological endoscopic minimally invasive surgery. Applicable to a variety of ureteral stones and some kidney stones that are ineffective in conservative treatment.
  • ureteroscopic lithotripsy Compared with ureterotomy, ureteroscopic lithotripsy has the advantages of small damage, light pain, quick recovery, etc. Compared with extracorporeal shock wave lithotripsy, its treatment course is shorter and more efficient.
  • ureteroscopic lithotripsy there are still some deficiencies in ureteroscopic lithotripsy.
  • the ureter, upper calculus and stone fragments are easily rushed back to the renal pelvis or into the renal pelvis by the recoil of the perfusion water or gravel tool, causing kidney stones and increasing the difficulty of surgery. Blocking the ureteral calculi with tools is an important means to prevent ureteral stones from being recoiled back to the kidneys.
  • ureteral occlusion devices in clinical practice. However, these ureteral occlusion devices still have certain disadvantages in practical use.
  • Boston's Boston Scientific also manufactures a Stone Cone stone basket, which is twisted into a conical mosquito-repellent disc structure. Applicants have found that it also has the problem of being easily burned by lasers. It becomes brittle after being burned, is easy to break, and cannot achieve effective sealing. There is a great risk.
  • a prior art product also discloses an occlusion device that can be used in ureteral calculi surgery.
  • the occlusion device When the occlusion device enters the body cavity, it can be in the form of a membrane, a strip, a strip, or the like before entering the body cavity.
  • a flat, tubular, sleeve or other irregular flat shape is unfolded, but a folded structure can be formed by pulling in its axial direction. Passing in its axial direction A guide wire is pulled, the plug is axially compressed, the length of the plug is shortened, the width is widened, and a plugging structure is formed, and the unfolded plug can be folded, twisted, spiraled or otherwise formed into a plug seal. Block the object and achieve effective sealing.
  • the volume of the occlusion in the flat shape is also large, which is inconvenient to place. There is also the possibility of pushing the stone to displace it during the placement process. The occlusion completely obstructs the fluid flow and is difficult to drag in the ureter. .
  • the technical problem to be solved by the present invention is to provide a closed net basket with stable structure and convenient placement, and a plugging device having the net basket.
  • the present invention provides a plugging net basket which is woven from a plurality of braided wires, and the composition of the plurality of braided filaments comprises a shape memory alloy and a high molecular polymer.
  • the shape memory alloy is a nickel-titanium shape memory alloy.
  • the high molecular polymer is selected from one or more of a fluoropolymer, a polyurethane, a nylon elastomer, polyethylene or polypropylene.
  • the fluoropolymer is polytetrafluoroethylene.
  • the plurality of braided filaments include a wire made of a shape memory alloy and a polymer filament made of a high molecular polymer.
  • the ratio of the number of wires to the polymer filaments is 1-49: 51-99.
  • the plurality of braided filaments comprises a composite braided filament comprising a metal core having an inner layer made of a shape memory alloy and a polymer sleeve made of a high molecular polymer coated outside the metal core.
  • the thickness of the polymer sleeve is from 0.01 mm to 2 mm.
  • the present invention further provides an occlusion device comprising an outer tube and a occlusion member, the occlusion member comprising a flexible soft head, a mandrel, a handle and any one of the above-mentioned plugging baskets, wherein the mandrel is disposed in the outer tube, The non-inserted end of the mandrel is connected to the handle, and the insertion end of the mandrel is covered with a flexible soft head, and the blocking basket is connected to the mandrel between the flexible soft head and the handle, and the handle is used to control the blocking of the basket to extend or Retract the outer tube.
  • an occlusion device comprising an outer tube and a occlusion member, the occlusion member comprising a flexible soft head, a mandrel, a handle and any one of the above-mentioned plugging baskets, wherein the mandrel is disposed in the outer tube, The non-inserted end of the mandrel is connected to the handle,
  • the plugging basket provided by the present invention is woven from a plurality of braided wires, and the composition of the plurality of braided filaments comprises a shape memory alloy and a high molecular polymer.
  • the shape memory alloy mainly plays the role of skeleton support and shaping; the polymer has better stability under laser than the shape memory alloy.
  • the plugged basket of the present invention has better memory resilience and better stability under laser light.
  • FIG. 1A is a schematic view showing a structure of a basket woven fabric provided by the present invention.
  • FIG. 1B is a schematic view showing another basket weaving structure provided by the present invention.
  • FIG. 2 is a schematic cross-sectional view of a composite braided yarn provided by the present invention.
  • Figure 3 is a schematic view showing the separation of the occlusion device provided by the present invention.
  • Figure 4 is a schematic perspective view showing a combined state of the occlusion device provided by the present invention.
  • FIG. 5 is a schematic perspective view showing another combined state of the occlusion device according to the present invention.
  • the "insertion end” in the present invention means the end portion farthest from the entrance portion of the cavity and the operator in the state of use, and the corresponding end portion closest to the cavity and the other end of the operator are non-insertion ends.
  • the invention provides a closure basket 210 which is woven from a plurality of braided wires, and the composition of the plurality of braided filaments comprises a shape memory alloy and a high molecular polymer.
  • the shape memory alloy mainly plays the role of skeleton support and shaping, so that the whole plugged basket 210 has better memory resilience; the polymer has better stability under laser than the shape memory alloy.
  • the plugged basket 210 of the present invention has better stability under laser light.
  • the shape memory alloy in the present invention refers to an alloy which is deformed when subjected to an external force and which can return to its original shape after the external force disappears.
  • Common shape memory alloys include nickel-titanium shape memory alloy, copper-nickel shape memory alloy, copper-aluminum shape memory alloy, copper-zinc shape memory alloy, and iron-based shape memory alloy (Fe-Mn-Si, Fe-Pd). Wait.
  • the nickel-titanium shape memory alloy has better elasticity and memory resilience, and in the present invention, a nickel-titanium shape memory alloy is preferably used.
  • the plugging basket provided by the present invention is not particularly limited in the composition of the high molecular polymer, and may be selected from polyolefins such as polyethylene and polypropylene, polyvinyl chloride, and the like as long as it can meet the needs of use of the stone basket.
  • Polyolefins such as polyethylene and polypropylene, polyvinyl chloride, and the like as long as it can meet the needs of use of the stone basket.
  • Polyester PET, PBT, etc.
  • polyamide polyimide
  • polyurethane polystyrene
  • polycarbonate silicone resin
  • fluoropolymer PTFE, ETFE, PFA, etc.
  • One or more of various rubber materials such as latex rubber, silicone rubber, and nylon elastomer.
  • the high molecular polymer is preferably one or more of a fluorine-containing polymer, a polyurethane, a nylon elastomer, polyethylene or polypropylene.
  • the fluoropolymer, polyurethane or nylon elastomer has good biocompatibility, so the plugged net basket 210 prepared by using the above three polymers has good affinity with the cavity and is not easy to be damaged. .
  • the fluoropolymer is preferably polytetrafluoroethylene.
  • PTFE has better stability under laser, and has low friction and good smoothness with human body channels, which can reduce the cavity during the movement of the blocking basket 210. Damage to the road.
  • the braided yarn of the present invention comprises a wire 211 made of a shape memory alloy, a polymer yarn 212 made of a polymer, and a composite braided yarn formed by a shape memory alloy and a high molecular polymer.
  • the composition of the plurality of braided filaments including the shape memory alloy and the high molecular polymer is achieved in various ways as follows. In a basket weaving structure as shown in FIG.
  • the wire 211 and the polymer wire 212 can be separately woven as separate units, if the wire 211 at one part of the basket breaks under the action of laser, the rest Part of the polymer wire 212 can also To a certain role of blocking the gravel, the overall amount of the shape memory alloy and the high molecular polymer using the preparation method is small, and the cost of sealing the basket 210 is low.
  • the wire 211 and the polymer wire 212 may also be woven together as a unit by entanglement or side by side, if the basket 210 is blocked.
  • the wire 211 at one place is broken by the laser and is broken, and the remaining polymer wire 212 can also function as a good seal for the crushed stone, and the sealing function of the basket is hardly affected.
  • a plurality of wires 211 and polymer wires 212 can be pre-processed by the above two methods of wire 211 and polymer wire 212, which can be adjusted by adjusting the number of wires 211 and polymer wires 212 in the weaving process. The amount of shape memory alloy and polymer.
  • the amount of the wire 211 and the polymer wire 212 used in the present invention is not particularly limited. As the amount of the polymer filaments 212 decreases, the weaving density of the polymer filaments 212 on the basket decreases, and the mesh 211 formed by the shape memory alloy on the basket becomes broken under the laser, and the grid of the basket becomes large. The size of the smallest debris that can be blocked by the basket is increased; when the amount of the polymer yarn 212 is increased, the braiding density of the wire 211 is lowered, and the stability of the basket under the laser is good, but the basket is deformed.
  • the memory resilience will be reduced, and the ratio of the amount of the wire 211 to the polymer wire 212 can be adjusted according to the stability of the basket and the resilience of the memory in actual use.
  • the number of the wires 211 and the polymer filaments 212 in the basket weaving process is 1-49: 51-99, in the range
  • the stability of the inner basket is greatly improved, and the memory resilience is comparable to a pure metal basket.
  • the ratio of the wire 211 to the polymer wire 212 is more preferably from 1 to 10:90 to 99.
  • the plurality of braided wires comprise composite braided filaments.
  • the composite braided filaments comprise a metal core 213 whose inner layer is made of a shape memory alloy, and a polymer core made of a metal core 213.
  • the basket prepared by using the polymer-coated shape memory alloy obtained by the composite braided wire has a stabilization time under the laser equivalent to that of the pure polymer material, even if the metal core 213 is broken due to the outer layer polymerization.
  • the coating of the material, the broken metal material will not be scattered in the cavity, the metal section will not scratch the cavity; and the memory resilience of the basket prepared by the composite yarn and the sealed net basket prepared by the pure memory alloy Quite, the channel can be fully blocked.
  • the wire 211 and/or the polymer wire 212 may be added to the net basket woven with the composite woven fabric to conveniently adjust the ratio of the shape memory alloy to the high molecular polymer.
  • the diameter of the metal core 213 is not particularly limited in the present invention, and the thickness of the polymer sleeve 214 is preferably 0.01 mm or more and 2 mm or less.
  • the basket may be a single layer basket or a multi-layer basket, wherein each layer basket is formed by a combination of a high molecular polymer and a shape memory alloy.
  • a structure common in the art such as a columnar shape or a disk shape, may be employed.
  • the basket is a columnar structure as shown in FIG.
  • the present invention is not particularly limited to the shape of the braided wire, and may be a circular, elliptical or hexagonal columnar structure, or may be a sheet-like structure.
  • the present invention also provides a occlusion device.
  • a schematic view of the occlusion device is provided in FIG. 3, which includes an outer tube 100 and a occlusion member 200.
  • the occlusion member 200 includes a flexible soft head.
  • the flexible soft head 240 formed by the material, the sealing net basket 210 is sleeved on the mandrel 220, and the sealing net basket 210 is fixed on the mandrel 220 between the flexible soft head 240 and the handle 230, preferably, the sealing net
  • the basket 210 is placed adjacent to the flexible soft head 240.
  • the handle 230 is used to control the basket to extend or retract the outer tube 100.
  • the outer tube 100 and the occluding member 200 are combined before use, wherein the clogging basket 210 is outside the outer tube 100.
  • the tamping basket 210 is pulled into the outer tube 100 through the handle 230, and the basket is compressed into the outer tube 100.
  • the diameter of the basket becomes smaller, the length increases, and then
  • the occlusion device is placed through the stone to the distal end of the stone, and then the occlusion mesh basket 210 is controlled by the handle 230 to extend toward the rear of the stone relative to the outer tube 100, so that the clogging basket 210 is restored.
  • the sealing basket 210 can be controlled to return to the outer tube 100 by the handle 230, and then the entire blocking device is taken out.
  • the mandrel 220 is a metal mandrel, preferably a stainless steel wire or a nickel-titanium alloy wire, but the invention is not limited thereto, and the mandrel 220 may be any filament-like structure, a filament-like structure. Any metal or non-metal material may also be used as long as the basic function of the blocking member 200 can be achieved.
  • the outer tube 100 may be a single layer or a multilayer structure, preferably a multilayer structure, for example, an outer layer formed of PEEK and/or nylon elastomer for providing affinity between the outer tube 100 and the channel.
  • the two materials have good stability, little change in properties, low temperature, no hardening, strong corrosion resistance and aging resistance.
  • the outer tube 100 made by this method will not change even if it is placed for a long time.
  • the intermediate layer is made of metal braid or spring reinforced structure to ensure the insertability and radial expansion of the outer tube 100.
  • the inner tube is made of a fluorine-containing material or a high-density polyethylene material for reducing the friction between the outer tube 100 and the blocking member 200, and is convenient for placing the blocking member 200.
  • the sealing net basket provided by the invention is woven by a plurality of braided wires, and the composition of the plurality of braided filaments comprises a shape memory alloy and a high molecular polymer, which can be used for sealing the urinary tract stones in the urinary system. And removed.
  • the plugged net basket is woven by shape memory alloy and high molecular polymer.
  • the shape memory alloy mainly plays the role of skeleton support and shaping; the polymer has better stability under laser than the shape memory alloy. Sex. By co-weaving the polymer material and the shape memory alloy, the plugging basket of the present invention has better memory resilience and better stability under laser light.

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Abstract

一种封堵网篮（210）及具有该网篮（210）的封堵装置，封堵网篮（210）由多根编制丝编织而成，多根编制丝的组成包括形状记忆合金和高分子聚合物。其中，形状记忆合金主要起骨架支撑、定型的作用；高分子聚合物相较于形状记忆合金在激光下具有更好的稳定性。通过聚合物材料和形状记忆合金共同编织，封堵网篮（210）记忆回弹性较好，并且在激光下具有更好的稳定性。

Description

一种封堵网篮及具有该网篮的封堵装置 技术领域
本发明涉及医疗器械技术领域，具体地说，是一种封堵网篮及具有该网篮的封堵装置。
背景技术
输尿管结石是泌尿外科的常见病之一。现今输尿管结石的主要治疗方法包括：体外冲击波碎石术(ESWL)、输尿管切开取石术及输尿管镜碎石术等。输尿管镜碎石术，是利用一条直径3mm左右的细镜，经过尿道、膀胱插入输尿管，将输尿管结石或肾脏结石击碎取出。它利用人体天然的泌尿系统腔道，不在身体上做任何切口，是一种纯粹的泌尿外科腔镜微创手术。适用于保守治疗无效的各种输尿管结石以及部分肾结石。与输尿管切开取石术相比，输尿管镜碎石术具有损伤小、痛苦轻、恢复快等优点；与体外冲击波碎石术相比，其治疗病程较短，有效率高。目前输尿管镜碎石取石术还存在一定不足，例如输尿管中、上段结石及结石碎片容易被灌注水流或碎石工具的反冲力冲回肾盂或进入肾盏，而引起肾脏结石，增大手术难度。通过工具封阻输尿管结石上方是防止输尿管结石被反冲回肾脏的重要手段，目前临床上也有一些输尿管封堵装置，然而这些输尿管封堵器在实际使用中仍存在一定的缺点。
美国COOK公司制造了一种N-Trap套石蓝，其是由金属丝编织而成的碗状结构，以在跨越结石后撑开呈碗状从而起到防止结石碎屑向肾内漂移。但是该套石蓝体积较大，不便于放置，在放置过程中还可能推动结石使其移位；除了上述缺点，申请人在研究中还发现，该产品在激光碎石的过程中容易被激光打断，使网篮发生破损，存在结石漏网的风险；并且在需要拖取移石的情况下，网篮金属丝的断面容易划伤输尿管管壁，严重者引起并发症。
美国的BostonScientific公司也制造了一种Stone Cone取石网篮，其是由金属丝扭转成一个锥形的蚊香盘结构，申请人在研究中发现其同样存在容易被激光灼烧的问题，网篮在被灼烧后变脆，容易断裂，不能够实现有效的封堵，存在很大风险。
在先的产品中还公开了一种可用于输尿管结石手术中的封堵装置，该装置的封堵物在进入体腔的时候，在未拉压之前，可以以膜状、条状、带状、片状、管状、袖状或其他不规则的扁平形状展开，但在其轴向方向上能通过牵拉形成折叠结构。在其轴向方向上通过 一导丝进行牵拉，封堵物被轴向压缩，封堵物长度变短，宽度变宽，形成封堵结构，展开的封堵物可以经折叠、扭曲、螺旋或其他方式形成栓状封堵物，实现有效的封堵。但是该封堵物在扁平形状下的体积也较大，不便于放置，同样存在在放置过程中推动结石使其移位的可能，该封堵物会彻底阻碍流体流动，难以在输尿管中进行拖曳。
因此，提供一种结构稳定、便于放置的封堵网篮及具有该网篮的封堵装置成为本医疗领域亟待解决的技术问题。
发明内容
本发明要解决的技术问题是提供一种结构稳定、便于放置的封堵网篮及具有该网篮的封堵装置。
为解决上述技术问题，本发明提供了一种封堵网篮，该网篮由多根编制丝编织而成，多根编制丝的组成包括形状记忆合金和高分子聚合物。
进一步地，形状记忆合金为镍钛系形状记忆合金。
进一步地，高分子聚合物选自含氟聚合物、聚氨酯、尼龙弹性体、聚乙烯或聚丙烯中的一种或几种。
进一步地，含氟聚合物为聚四氟乙烯。
进一步地，多根编制丝包括由形状记忆合金制成的金属丝和由高分子聚合物制成的聚合物丝。
进一步地，金属丝和聚合物丝的根数比为1-49：51-99。
进一步地，多根编制丝包括复合编制丝，复合编制丝包括内层由形状记忆合金制成的金属芯，和包覆在金属芯外的由高分子聚合物制成的聚合物套。
进一步地，聚合物套的厚度为0.01mm-2mm。
进一步地，本发明还提供了一种封堵装置，包括外管和封堵构件，封堵构件包括柔性软头、芯轴、手柄和上述任一种封堵网篮，芯轴设置在外管内，芯轴的非插入端连接手柄，芯轴的插入端包覆有柔性软头，封堵网篮连接在柔性软头和手柄之间的芯轴上，手柄用于控制封堵网篮伸出或缩回外管。
综上所述，本发明提供的封堵网篮由多根编制丝编织而成，多根编制丝的组成包括形状记忆合金和高分子聚合物。其中，形状记忆合金主要起骨架支撑、定型的作用；高分子聚合物相较于形状记忆合金在激光下具有更好的稳定性。通过聚合物材料和形状记忆合金共同编织，本发明的封堵网篮记忆回弹性较好，并且在激光下具有更好的稳定性。
附图说明
下面结合附图和具体实施方式对本发明作进一步详细的说明：
图1A为本发明所提供的一种网篮编织结构示意图；
图1B为本发明所提供的另一种网篮编织结构示意图；
图2为本发明所提供的复合编制丝的剖面示意图；
图3为本发明所提供的封堵装置的分离示意图；
图4为本发明所提供的封堵装置的一种结合状态透视示意图；
图5为本发明所提供的封堵装置的另一种结合状态透视示意图。
元件标号如下：
100-外管
200-封堵构件
210-封堵网篮
211-金属丝
212-聚合物丝
213-金属芯
214-聚合物套
220-芯轴
230-手柄
240-柔性软头
具体实施方式
现在结合附图，详细介绍本发明的较佳实施方式。虽然本发明的描述将结合各个实施方式一起介绍，但这并不代表此发明的特征仅限于该几种实施方式。恰恰相反，结合实施方式作发明介绍的目的是为了覆盖基于本发明的权利要求而有可能延伸出的其它选择或改造。为了提供对本发明的深度了解，以下描述中将包含许多具体的细节。本发明也可以不使用这些细节实施。此外，为了避免混乱或模糊本发明的重点，有些具体细节将在描述中被省略。
另外，在以下的说明中所使用的“上”、“下”、“左”、“右”、“顶”、“底”，是为了更 好地描述本发明的较佳实施方式而设定的，不应理解为对本发明的限制。
本发明中的“插入端”是指在使用状态下，距离腔体入口部位和操作者最远的一端，对应的最靠近腔体入口部位和操作者的另一端即为非插入端。
本发明提供了一种封堵网篮210，该网篮由多根编制丝编织而成，多根编制丝的组成包括形状记忆合金和高分子聚合物。其中，形状记忆合金主要起骨架支撑、定型的作用，使整个封堵网篮210具有较好的记忆回弹性；高分子聚合物相较于形状记忆合金在激光下具有更好的稳定性，在加入了高分子聚合物后，本发明的封堵网篮210在激光下具有更好的稳定性。
进一步地，本发明中的形状记忆合金是指在受到外力作用时发生变形，在外力消失后又可以恢复其原始形状的合金。常见的形状记忆合金有镍钛系形状记忆合金、铜镍系形状记忆合金、铜铝系形状记忆合金、铜锌系形状记忆合金、铁系形状记忆合金(Fe-Mn-Si,Fe-Pd)等。在前述的形状记忆合金中，镍钛系形状记忆合金拥有更好的弹性和记忆回弹性，本发明中优选采用镍钛系形状记忆合金。
进一步地，本发明提供的封堵网篮对于高分子聚合物的组成没有特殊限定，只要能够满足取石网篮的使用需要即可，可以选自聚乙烯、聚丙烯等聚烯烃、聚氯乙烯、聚酯(PET、PBT等)、聚酰胺、聚酰亚胺、聚氨酯、聚苯乙烯、聚碳酸酯、有机硅树脂、含氟聚合物(PTFE、ETFE、PFA等)或者这些材料的复合材料、胶乳橡胶、硅氧橡胶、尼龙弹性体等各种橡胶材料中的一种或几种。
进一步地，为使封堵网篮210在激光下具有更好的稳定性，高分子聚合物优选自含氟聚合物、聚氨酯、尼龙弹性体、聚乙烯或聚丙烯中的一种或几种，其中，含氟聚合物、聚氨酯或尼龙弹性体都拥有较好的生物相容性，因而采用前述三种聚合物制备的封堵网篮210与腔体的亲和性较好，并且不易发生破损。
更进一步地，含氟聚合物优选为聚四氟乙烯。相较于其他高分子聚合物材料，聚四氟乙烯在激光下的稳定性较好，并且摩擦力小，与人体腔道的顺滑性好，可以减少封堵网篮210移动过程中对腔道的损伤。
进一步地，本发明中的编制丝包括采用形状记忆合金制成的金属丝211、高分子聚合物制成的聚合物丝212以及由形状记忆合金与高分子聚合物共同形成的复合编制丝。多根编制丝的组成包括形状记忆合金和高分子聚合物通过以下多种方式实现。如图1A所示的一种网篮编织结构中，金属丝211和聚合物丝212可以分别作为独立的编制单位进行编织，如果网篮某一处的金属丝211在激光作用下发生破损，剩余部分的聚合物丝212也可以起 到一定的封堵碎石的作用，采用这种编制方法的形状记忆合金和高分子聚合物的整体用量少，封堵网篮210的成本较低。
优选地，如图1B所示的另一种网篮编织结构，金属丝211和聚合物丝212也可以通过缠结或者是并排的方式共同作为一个编制单位进行编织，如果封堵网篮210某一处的金属丝211被激光击断而发生破损，剩余的聚合物丝212也可以起到很好的封堵碎石的作用，网篮的封堵功能几乎不会受到影响。
采用上述两种由金属丝211和聚合物丝212共同编制的方法，可以预先加工大量的金属丝211和聚合物丝212，通过调整编织过程中金属丝211和聚合物丝212的数量就可以调节形状记忆合金与高分子聚合物用量。
进一步地，本发明对于金属丝211和聚合物丝212的用量没有特殊限定。随着聚合物丝212用量的减少，网篮上聚合物丝212的编织密度下降，网篮上的形状记忆合金形成的金属丝211在激光下发生破碎时，网篮的网格变大，网篮可封堵的最小碎石的尺寸增大；当聚合物丝212的用量增加时，金属丝211的编制密度降低，网篮在激光下的稳定性较好，但是这样网篮在变形后的记忆回弹性会有所降低，可以根据实际使用中对网篮的稳定性和记忆回弹性的需要调节金属丝211和聚合物丝212的用量比。从兼顾网篮在激光下的稳定性和记忆回弹性两方面考虑，优选地，金属丝211和聚合物丝212在网篮编织过程中的根数比1-49：51-99，在该范围内网篮的稳定性得到极大地提高，而记忆回弹性与纯的金属网篮相当。金属丝211和聚合物丝212的比例更优选为1-10：90-99。
进一步地，多根编制丝包括复合编制丝，如图2所示，复合编制丝包括内层由形状记忆合金制成的金属芯213，和包覆在金属芯213外的由高分子聚合物制成的聚合物套214。采用这种高分子聚合物包覆形状记忆合金得到的复合编制丝制备的网篮，在激光下的稳定时间与纯聚合物材料制备的网篮相当，即使金属芯213发生断裂，由于外层聚合物的包覆，断裂的金属材料也不会散落在腔道，金属的断面也不会划伤腔道；并且复合编制丝制备的网篮的记忆回弹性与纯记忆合金制备的封堵网篮相当，可以充分地对腔道进行封堵。更进一步地，还可以在采用复合编制丝编织的网篮中加入金属丝211和/或聚合物丝212以方便地调节形状记忆合金和高分子聚合物的用量比。
进一步地，本发明对于金属芯213的直径没有特殊限定，聚合物套214的厚度优选0.01mm以上，2mm以下。
进一步地，网篮可以是单层网篮或多层网篮，其中每一层网篮都是由高分子聚合物和形状记忆合金共同形成的。对于网篮的整体结构可以采用本领域常见的结构，如柱状或圆盘状，优选地，网篮为图3所示的柱状结构。
进一步地，本发明对于编制丝的形状没有特殊限定，可以是圆形、椭圆形或者是六边形的柱状结构，也可以是片状的结构。
进一步地，本发明还提供了一种封堵装置，为了便于观察，图3中提供了该封堵装置的分离示意图，其包括外管100和封堵构件200，封堵构件200包括柔性软头240、芯轴220、手柄230和上述任一种封堵网篮210，芯轴220设置在外管100内，芯轴220的非插入端连接手柄230，芯轴220的插入端包覆有由聚合物材料形成的柔性软头240，封堵网篮210套设在芯轴220上，封堵网篮210固定在柔性软头240和手柄230之间的芯轴220上，优选地，封堵网篮210靠近柔性软头240设置。手柄230用于控制网篮伸出或缩回外管100。
进一步地，如图4所示，在使用之前，外管100和封堵构件200组合在一起，其中封堵网篮210在外管100外。如图5所示，在使用过程中，通过手柄230将封堵网篮210拉入到外管100中，网篮被压缩到外管100内，网篮的直径变小，长度增加，然后在内窥镜存在下，将该封堵装置穿过结石置入到结石的远端，而后通过手柄230控制封堵网篮210相对于外管100向结石后方伸出，使得封堵网篮210恢复至如图4所示的原始形状，以对腔道壁形成充分的封堵。在激光碎石和取石过程完成后，可以通过手柄230控制封堵网篮210回到外管100内，随后，取出整个封堵装置。
进一步地，网篮仅一端固定在芯轴220上，与柔性软头240相连接，网篮的另一端可沿芯轴220上下滑动，芯轴220的一端具有限位机构，防止网篮在外管100中被超负荷压缩，影响记忆回弹性。更进一步地，芯轴220为金属芯轴，优选地，为不锈钢丝或镍钛合金丝，但本发明并不局限于此，芯轴220还可以是任何细丝状的结构，细丝状结构还可以选用任何金属或非金属材质，只要能够实现封堵构件200的基本功能即可。
进一步地，外管100可以为单层或多层结构，优选为多层结构，例如，采用PEEK和/或尼龙弹性体形成外层，用于提供外管100与腔道之间的亲和性，避免刺伤内壁，这两种材料稳定性好，性质变化很小，低温不硬化，耐腐蚀和耐老化能力强，以此制成的外管100即使长时间放置，结构也不会发生变化。中间层采用金属编织或弹簧增强结构，保证外管100的插入性和径向扩张性。内管采用含氟材料或高密度聚乙烯材料，用于降低外管100和封堵构件200之间的摩擦力，便于放置封堵构件200。
综上所述，本发明提供的封堵网篮由多根编制丝编织而成，多根编制丝的组成包括形状记忆合金和高分子聚合物，可以用于泌尿系统中尿路结石的封堵和移除。封堵网篮由形状记忆合金和高分子聚合物共同编织而成，其中，形状记忆合金主要起骨架支撑、定型的作用；高分子聚合物相较于形状记忆合金在激光下具有更好的稳定性。通过聚合物材料和形状记忆合金共同编织，使本发明的封堵网篮具有较好的记忆回弹性，并且在激光下具有更好的稳定性。
上述的说明是本发明中具体实施方式的实施例，用于更清楚地说明本发明的发明构思，但其并非是用于对本发明的权利要求范围的限定。根据本发明的发明构思，本领域技术人员能够容易变型和修改上述的实施例，这些属于本发明的发明构思内的变型和修改均包含在本发明后附的权利要求的范围之内。

Claims (9)

  1. 一种封堵网篮，其特征在于，所述网篮由多根编制丝编织而成，所述多根编制丝的组成包括形状记忆合金和高分子聚合物。
  2. 如权利要求1所述的封堵网篮，其特征在于，所述形状记忆合金为镍钛系形状记忆合金。
  3. 如权利要求1所述的封堵网篮，其特征在于，所述高分子聚合物选自含氟聚合物、聚氨酯、尼龙弹性体、聚丙烯或聚乙烯中的一种或几种。
  4. 如权利要求3所述的封堵网篮，其特征在于，所述含氟聚合物为聚四氟乙烯。
  5. 如权利要求1所述的封堵网篮，其特征在于，所述多根编制丝包括由所述形状记忆合金制成的金属丝和由所述高分子聚合物制成的聚合物丝。
  6. 如权利要求5所述的封堵网篮，其特征在于，所述金属丝和所述聚合物丝的根数比为1-49：51-99。
  7. 如权利要求1所述的封堵网篮，其特征在于，所述多根编制丝包括复合编制丝，所述复合编制丝包括内层由所述形状记忆合金制成的金属芯，和包覆在所述金属芯外的由所述高分子聚合物制成的聚合物套。
  8. 如权利要求7所述的封堵网篮，其特征在于，所述聚合物套的厚度为0.01mm至2mm。
  9. 一种封堵装置，其特征在于，包括外管和封堵构件，所述封堵构件包括柔性软头、芯轴、手柄和权利要求1-8中任一项所述的封堵网篮，所述芯轴设置在所述外管内，所述芯轴的非插入端连接所述手柄，所述芯轴的插入端包覆有所述柔性软头，所述封堵网篮连接在所述柔性软头和所述手柄之间的所述芯轴上，所述手柄用于控制所述封堵网篮伸出或缩回所述外管。
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