CN115919519A - Stent Delivery System - Google Patents
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Abstract
Description
技术领域technical field
本发明涉及医疗器械技术领域,特别涉及一种支架输送系统。The invention relates to the technical field of medical devices, in particular to a stent delivery system.
背景技术Background technique
动脉瘤,是一种严重的动脉血管病变,会对人体造成极大的损害,一方面动脉瘤的增大会压迫周围的神经、动静脉组织,造成身体不适应或者部分功能的丧失,一方面动脉瘤因为瘤壁老化或者外部力量等原因造成破裂,会造成出血,危害生命。特别是脑部动脉瘤的破裂,也称脑卒中,具备相当高的致死致残率。但是,随着人们生活水平的提高以及环境的恶化,动脉瘤发病的概率再逐步升高,如果不及时治疗,将产生严重的损害。Aneurysm is a serious arterial vascular disease, which will cause great damage to the human body. On the one hand, the enlargement of the aneurysm will compress the surrounding nerves and arteriovenous tissues, causing physical discomfort or loss of some functions. The tumor is ruptured due to the aging of the tumor wall or external force, which will cause bleeding and endanger life. Especially the rupture of cerebral aneurysm, also known as stroke, has a very high rate of death and disability. However, with the improvement of people's living standards and the deterioration of the environment, the probability of aneurysm morbidity is gradually increasing. If it is not treated in time, it will cause serious damage.
在动脉瘤的形成部位中,以颅内的动脉瘤最为难以治疗。常用的动脉瘤治疗方法包括:1)外科手术夹闭,需要用金属夹固定在动脉瘤的颈部。2)使用栓塞材料的介入手术,如弹簧圈和液体栓塞剂填塞动脉瘤。3)使用血管内支架的介入手术。其中介入手术相比传统的开颅手术,对病人的创伤小、治愈快、复发率低以及后遗症少,获得了大多数医生和患者的认可。其中使用血管内支架术通过对于载瘤血管的血流重建,减少进入动脉瘤的血流,使动脉瘤逐渐萎缩,从而减少其“占位”效应,而使用栓塞材料则无法解决动脉瘤的“占位”问题。因此,血管内支架治疗动脉瘤是目前最理想的治疗方案。Among the formation sites of aneurysms, intracranial aneurysms are the most difficult to treat. Commonly used aneurysm treatment methods include: 1) Surgical clipping, which needs to be fixed on the neck of the aneurysm with a metal clip. 2) Interventional procedures using embolic materials such as coils and liquid embolic agents to occlude the aneurysm. 3) Interventional surgery using intravascular stents. Among them, compared with traditional craniotomy, interventional surgery has less trauma to patients, faster healing, lower recurrence rate and fewer sequelae, and has been recognized by most doctors and patients. Among them, the use of endovascular stenting reduces the blood flow into the aneurysm by reconstructing the blood flow of the parent vessel, so that the aneurysm gradually shrinks, thereby reducing its "occupancy" effect, while the use of embolization materials cannot solve the "occupancy" effect of the aneurysm. space” problem. Therefore, endovascular stent treatment of aneurysms is currently the most ideal treatment option.
血管内支架的介入手术,植入支架的主要工具是支架的输送系统。在手术前,支架已经通过特殊工艺方法压缩到输送系统的特定位置。首先医生通过影像方法确定动脉瘤的位置、形状和大小;然后根据相关参数选择合适的支架规格;随后在影像的引导下,从合适的将支架输送进入人体血管,并经特定的路径到达病变点;随后输送系统释放支架,支架会膨胀,支撑血管壁;最后,将释放完成的输送系统抽出,手术过程基本完成。In the interventional operation of the intravascular stent, the main tool for implanting the stent is the delivery system of the stent. Before surgery, the stent has been compressed into a specific location on the delivery system by a special process. Firstly, the doctor determines the location, shape and size of the aneurysm through imaging methods; then selects the appropriate stent specification according to the relevant parameters; then, under the guidance of the image, the stent is delivered from the appropriate place into the human blood vessel, and reaches the lesion point through a specific path ; Subsequently, the delivery system releases the stent, and the stent will expand to support the vessel wall; finally, the released delivery system is pulled out, and the operation process is basically completed.
该手术的关键是能够在支架释放过程中,支架能够准确定位,否则由于支架释放位置错误,支架不能完全打开或不能扩开血管,导致达不到预期手术效果甚至手术失败。但是,在实际临床应用中,支架往往在释放过程中,需要回撤后进行重新定位。The key to this operation is that the stent can be accurately positioned during the stent release process. Otherwise, due to the wrong release position of the stent, the stent cannot be fully opened or the blood vessel cannot be expanded, resulting in failure to achieve the desired surgical effect or even surgical failure. However, in actual clinical applications, the stent often needs to be retracted and then repositioned during the release process.
申请号为CN201510325188.1的中国专利文献公开了一种支架输送系统,通过推送导丝推压锚部件控制支架的释放位置。The Chinese patent document with application number CN201510325188.1 discloses a stent delivery system, which controls the release position of the stent by pushing the guide wire to push the anchor component.
申请号为CN201610170895.2的中国专利文献公开了一种可回收的支架输送系统,通过后固定卡住支架末端,从而实现在释放过程中可回收的功能。The Chinese patent document with the application number CN201610170895.2 discloses a recyclable stent delivery system, through which the end of the stent is clamped by post-fixation, so as to realize the function of recyclability during the release process.
上述专利文献在支架推送及释放上进行创新,提高了支架和释放性能,但是可以看出,上述专利没有关注支架输送系统在反复推送回撤后的可靠性,由于在卡爪的反复拉拽后,支架网格的局部受到推送和回撤力,支架的网孔会因为受力而变形扩大,导致支架容易出现打开不充分,不贴壁和无法回收的情况,手术并发症的风险很大。The above-mentioned patent documents innovated on the push and release of the stent, which improved the performance of the stent and the release. However, it can be seen that the above-mentioned patent did not pay attention to the reliability of the stent delivery system after repeated push and retraction. , Part of the stent grid is pushed and retracted, and the mesh of the stent will be deformed and expanded due to the force, resulting in insufficient opening of the stent, non-adhesion to the wall, and failure to recover. The risk of surgical complications is high.
发明内容Contents of the invention
本发明提供一种支架输送系统,解决了支架的网孔会因为受力而变形扩大,导致支架容易出现打开不充分,不贴壁和无法回收的问题。The invention provides a stent conveying system, which solves the problem that the mesh of the stent will be deformed and expanded due to the force, which will cause the stent to be easily opened insufficiently, not attached to the wall and unable to be recycled.
为解决上述技术问题,本发明提供一种支架输送系统,包括:In order to solve the above technical problems, the present invention provides a stent delivery system, comprising:
推送芯丝;Push the core wire;
支架,环绕设置于部分所述推送芯丝外,所述支架具有若干网孔;a bracket, which is arranged around a part of the pushing core wire, and the bracket has a plurality of mesh holes;
至少一个卡爪组件,位于所述推送芯丝与所述支架之间,所述卡爪组件包括至少一个弹性件及至少两个卡爪,所述卡爪及所述弹性件均沿所述推送芯丝的轴向套设于所述推送芯丝上,所述弹性件位于相邻两个所述卡爪之间并连接两个所述卡爪,所述卡爪具有至少一个凸起部,所述凸起部沿所述推送芯丝的径向朝背离所述推送芯丝的方向延伸并卡入对应的所述网孔中,所述支架在推送及回撤的过程中所述弹性件始终处于拉伸状态,以使相邻两个所述卡爪在所述弹性件的作用下夹紧,进而抓紧所述网孔。At least one claw assembly is located between the pushing core wire and the bracket, the claw assembly includes at least one elastic member and at least two claws, the claw and the elastic member are both pushed along the pushing The core wire is axially sleeved on the pushing core wire, the elastic member is located between two adjacent claws and connects the two claws, the claw has at least one protrusion, The protruding portion extends in a direction away from the pushing core wire along the radial direction of the pushing core wire and snaps into the corresponding mesh hole. When the stent is pushed and retracted, the elastic member It is always in a stretched state, so that two adjacent claws are clamped under the action of the elastic member, and then grasp the mesh.
可选的,所述支架的内部还设置有膨胀体,所述膨胀体固定在所述推送芯丝上,初始状态下,所述膨胀体压握于所述支架内,当所述支架展开后,所述膨胀体进行自膨胀并用于对所述支架的内壁进行按摩。Optionally, an expansion body is also provided inside the stent, and the expansion body is fixed on the pushing core wire. In the initial state, the expansion body is held in the stent. When the stent is deployed , the expansion body is self-expanding and used to massage the inner wall of the bracket.
可选的,所述膨胀体自膨胀后的外壁与所述支架展开后的内壁贴合。Optionally, the self-expanded outer wall of the expansion body is in close contact with the deployed inner wall of the stent.
可选的,所述支架输送系统还包括固定在所述推送芯丝上的至少一个限位件对,所述限位件对包括分别位于所述卡爪组件两侧的两个第一限位件,用于限制所述卡爪组件中的卡爪沿所述推送芯丝的轴向移动。Optionally, the stent delivery system further includes at least one pair of stoppers fixed on the pushing core wire, the pair of stoppers includes two first stoppers respectively located on both sides of the claw assembly. A component is used to limit the movement of the claws in the claw assembly along the axial direction of the pushing core wire.
可选的,所述支架输送系统还包括固定在所述推送芯丝上的至少一个第二限位件,所述第二限位件位于所述卡爪组件的远端侧以在回撤所述支架时限制所述卡爪向远端移动,所述推送芯丝位于所述卡爪组件的近端侧的区域设置一限位段,所述限位段的直径大于所述卡爪的内径以在输送所述支架时限制所述卡爪向近端移动。Optionally, the stent delivery system further includes at least one second limiter fixed on the pushing core wire, the second limiter is located on the distal side of the jaw assembly to When the stent is described, the jaws are restricted from moving to the distal end, and a limiting section is provided in the region where the pushing core wire is located on the proximal side of the jaw assembly, and the diameter of the limiting section is larger than the inner diameter of the jaws. In order to limit the proximal movement of the claw when delivering the stent.
可选的,所述卡爪可旋转地套设于所述推送芯丝上。Optionally, the claw is rotatably sleeved on the pushing core wire.
可选的,所述卡爪具有多个凸起部,多个所述凸起部沿所述推送芯丝的周向分布。Optionally, the claw has a plurality of protrusions, and the plurality of protrusions are distributed along the circumferential direction of the pushing core wire.
可选的,所述卡爪卡入所述网孔中的一端的尺寸与所述网孔的尺寸相适应。Optionally, the size of the end of the jaw that is inserted into the mesh is adapted to the size of the mesh.
可选的,所述凸起部卡入所述网孔中的一端具有倒圆边缘。Optionally, one end of the raised portion snapped into the mesh has a rounded edge.
可选的,所述卡爪的材质为金属或刚性聚合物。Optionally, the claw is made of metal or rigid polymer.
可选的,所述推送芯丝包括从远端到近端顺次设置的第一变径段、定径段及第二变径段,所述第一变径段及第二变径段的直径从远端到近端逐渐增大,所述定径段的直径保持不变,所述定径段的直径大于或等于所述第一变径段的最大直径且小于或等于所述第二变径段的最小直径,所述支架环绕设置于所述第一变径段外。Optionally, the pushing core wire includes a first reducing section, a fixed diameter section and a second reducing section arranged in sequence from the distal end to the proximal end, the first reducing section and the second reducing section The diameter gradually increases from the far end to the proximal end, and the diameter of the sizing section remains constant. The diameter of the sizing section is greater than or equal to the maximum diameter of the first variable diameter section and less than or equal to the second The minimum diameter of the reducing section, the support is arranged around the first reducing section.
可选的,所述定径段上套设有加固弹簧。Optionally, a reinforcing spring is sheathed on the sizing section.
可选的,所述加固弹簧及所述第二变径段的外侧还套设有热缩管。Optionally, a heat-shrinkable tube is sheathed on the outside of the reinforcement spring and the second diameter-reducing section.
可选的,所述推送芯丝为一体成型结构。Optionally, the pushing core wire is integrally formed.
可选的,所述推送芯丝具有相对的近端及远端,所述远端套设有弹簧导丝。Optionally, the pushing core wire has an opposite proximal end and a distal end, and the distal end is sheathed with a spring guide wire.
可选的,所述支架为由柔性金属丝编织而成的网状结构,所述柔性金属丝的材质为镍钛诺、铂、铂-钨合金、不锈钢、钴-铬合金或钴-镍合金中的至少一种。Optionally, the stent is a mesh structure woven by flexible metal wires, and the material of the flexible metal wires is Nitinol, platinum, platinum-tungsten alloy, stainless steel, cobalt-chromium alloy or cobalt-nickel alloy at least one of the
可选的,所述柔性金属丝的外壁涂覆聚合物涂层,所述柔性金属丝与聚合物涂层之间还覆盖有硅烷层,所述硅烷层与所述聚合物涂层通过共价键连接。Optionally, the outer wall of the flexible metal wire is coated with a polymer coating, and a silane layer is also covered between the flexible metal wire and the polymer coating, and the silane layer and the polymer coating are covalently key connection.
可选的,所述弹性件为弹簧。Optionally, the elastic member is a spring.
可选的,所述支架输送系统还包括微导管,所述推送芯丝及所述支架均位于所述微导管内,且所述推送芯丝能够沿所述导管主体的轴向移动以释放或回收所述支架。Optionally, the stent delivery system further includes a microcatheter, the pushing core wire and the stent are located in the microcatheter, and the pushing core wire can move along the axial direction of the catheter body to release or Recover the stent.
综上所述,本发明提供了一种支架输送系统,通过在推送芯丝与支架之间设置卡爪和弹性件,所述卡爪具有至少一个凸起部,所述凸起部沿所述推送芯丝的径向朝背离所述推送芯丝的方向延伸并卡入对应的所述网孔中,所述支架在推送及回撤的过程中所述弹性件始终处于拉伸状态,以使相邻两个所述卡爪在所述弹性件的作用下夹紧,进而抓紧所述网孔,配合所述弹性件的自伸缩调节避免了对局部网孔产生拉伸和挤压力,进而解决了支架的网孔会因为受力而变形扩大,导致支架容易出现打开不充分,不贴壁和无法回收的问题。To sum up, the present invention provides a stent delivery system. A claw and an elastic member are provided between the pushing core wire and the stent, the claw has at least one protruding portion, and the protruding portion is along the The radial direction of the push core wire extends away from the push core wire and snaps into the corresponding mesh, and the elastic member is always in a stretched state during the pushing and retracting process of the stent, so that The two adjacent claws are clamped under the action of the elastic member, and then grasp the mesh, and cooperate with the self-stretching adjustment of the elastic member to avoid stretching and squeezing force on the local mesh, and then It solves the problem that the mesh of the stent will be deformed and expanded due to the force, causing the stent to be prone to insufficient opening, non-adhesion to the wall and failure to recycle.
附图说明Description of drawings
本领域的普通技术人员应当理解,提供的附图用于更好地理解本发明,而不对本发明的范围构成任何限定。Those skilled in the art should understand that the accompanying drawings are provided for better understanding of the present invention, and do not constitute any limitation to the scope of the present invention.
图1是本发明实施例提供的支架输送系统的结构示意图。Fig. 1 is a schematic structural diagram of a stent delivery system provided by an embodiment of the present invention.
图2是本发明实施例提供的卡爪组件位于支架内的结构示意图。Fig. 2 is a schematic diagram of the structure of the claw assembly provided in the embodiment of the present invention located in the bracket.
图3是本发明实施例提供的卡爪组件的结构示意图。Fig. 3 is a schematic structural view of the claw assembly provided by the embodiment of the present invention.
图4是本发明另一个实施例提供的支架输送系统的结构示意图。Fig. 4 is a schematic structural view of a stent delivery system provided by another embodiment of the present invention.
附图中:In the attached picture:
10-推送芯丝;20-支架;30-卡爪组件;31-卡爪;32-弹性件;40-微导管;50-膨胀体;60-第一限位件;61-第二限位件;62-限位段;70-加固弹簧;71-热缩管;80-弹簧导丝;90-荧光标记;10-pushing core wire; 20-bracket; 30-claw assembly; 31-claw; 32-elastic member; 40-microcatheter; 62-Limiting section; 70-Reinforcing spring; 71-Heat shrink tube; 80-Spring guide wire; 90-Fluorescent mark;
310-凸起部。310 - Raised portion.
具体实施方式Detailed ways
正如背景技术所述,血管内支架的介入手术,植入支架的主要工具是支架的输送系统,该手术的关键是能够在支架释放过程中,支架能够准确定位,否则由于支架释放位置错误,支架不能完全打开或不能扩开血管,导致达不到预期手术效果甚至手术失败。但是,在实际临床应用中,支架往往在释放过程中,需要回撤后进行重新定位。As mentioned in the background technology, in the interventional operation of intravascular stent, the main tool for implanting the stent is the delivery system of the stent. The key to this operation is that the stent can be accurately positioned during the stent release process, otherwise the stent will be damaged due to the wrong position of the stent release The blood vessels cannot be fully opened or dilated, resulting in failure to achieve the expected surgical effect or even surgical failure. However, in actual clinical applications, the stent often needs to be retracted and then repositioned during the release process.
目前公开的技术中,虽然实现了支架的推送和回撤,但是并没有考虑到支架输送系统在反复推送回撤后的可靠性,由于在卡爪的反复拉拽后,支架网格的局部受到推送和回撤力,支架的网孔会因为受力而变形扩大,导致支架容易出现打开不充分,不贴壁和无法回收的情况,手术并发症的风险很大。In the currently disclosed technology, although the push and retraction of the stent is realized, the reliability of the stent delivery system after repeated push and retraction is not considered. Pushing and retracting force, the mesh of the stent will be deformed and expanded due to the force, resulting in insufficient opening of the stent, non-adhesion to the wall and failure to recover, and the risk of surgical complications is high.
为了解决上述问题,本发明提供了一种支架输送系统,通过在推送芯丝与支架之间设置卡爪和弹性件,所述卡爪具有至少一个凸起部,所述凸起部沿所述推送芯丝的径向朝背离所述推送芯丝的方向延伸并卡入对应的所述网孔中,所述支架在推送及回撤的过程中所述弹性件始终处于拉伸状态,以使相邻两个所述卡爪在所述弹性件的作用下夹紧,进而抓紧所述网孔,配合所述弹性件的自伸缩调节避免了对局部网孔产生拉伸和挤压力,进而解决了支架的网孔会因为受力而变形扩大,导致支架容易出现打开不充分,不贴壁和无法回收的问题。In order to solve the above problems, the present invention provides a stent delivery system, by setting claws and elastic members between the pushing core wire and the stent, the claw has at least one protruding portion, and the protruding portion is along the The radial direction of the push core wire extends away from the push core wire and snaps into the corresponding mesh, and the elastic member is always in a stretched state during the pushing and retracting process of the stent, so that The two adjacent claws are clamped under the action of the elastic member, and then grasp the mesh, and cooperate with the self-stretching adjustment of the elastic member to avoid stretching and squeezing force on the local mesh, and then It solves the problem that the mesh of the stent will be deformed and expanded due to the force, causing the stent to be prone to insufficient opening, non-adhesion to the wall and failure to recycle.
为使本发明的目的、优点和特征更加清楚,以下结合附图和具体实施例对本发明作进一步详细说明。需说明的是,附图均采用非常简化的形式且未按比例绘制,仅用以方便、明晰地辅助说明本发明实施例的目的。此外,附图所展示的结构往往是实际结构的一部分。特别的,各附图需要展示的侧重点不同,有时会采用不同的比例。In order to make the purpose, advantages and features of the present invention clearer, the present invention will be further described in detail below in conjunction with the accompanying drawings and specific embodiments. It should be noted that the drawings are all in very simplified form and not drawn to scale, and are only used to facilitate and clearly assist the purpose of illustrating the embodiments of the present invention. In addition, the structures shown in the drawings are often a part of the actual structure. In particular, each drawing needs to display different emphases, and sometimes uses different scales.
如在本发明中所使用的,单数形式“一”、“一个”以及“该”包括复数对象,术语“或”通常是以包括“和/或”的含义而进行使用的,术语“若干”通常是以包括“至少一个”的含义而进行使用的,术语“至少两个”通常是以包括“两个或两个以上”的含义而进行使用的,此外,术语“第一”、“第二”、“第三”仅用于描述目的,而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此,限定有“第一”、“第二”、“第三”的特征可以明示或者隐含地包括一个或者至少两个该特征,除非内容另外明确指出外。As used in the present invention, the singular forms "a", "an" and "the" include plural objects, the term "or" is usually used in the sense of including "and/or", and the term "several" Usually, the term "at least one" is used in the meaning of "at least one", and the term "at least two" is usually used in the meaning of "two or more". In addition, the terms "first", "second "Two" and "third" are used for descriptive purposes only, and should not be understood as indicating or implying relative importance or implicitly indicating the quantity of the indicated technical features. Therefore, a feature defined as "first", "second", and "third" may explicitly or implicitly include one or at least two of these features, unless the content clearly states otherwise.
本文中“近端”和“远端”的定义为:“近端”通常指该医疗设备在正常操作过程中靠近操作者的一端,而“远端”通常是指该医疗设备在正常操作过程中首先进入患者体内的一端。The definitions of "proximal" and "distal" in this article are: "proximal" usually refers to the end of the medical device that is close to the operator during normal operation, and "distal" generally refers to the end of the medical device that is close to the operator during normal operation. The end that first enters the patient's body.
以下请参照附图进行描述。Please refer to the accompanying drawings for description below.
如图1-图3所示,图1是本发明实施例提供的支架输送系统的结构示意图,图2是本发明实施例提供的卡爪组件位于支架内的结构示意图,图3是本发明实施例提供的卡爪组件的结构示意图。本发明实施例提供了一种支架输送系统,包括:As shown in Figures 1 to 3, Figure 1 is a schematic structural view of a stent delivery system provided by an embodiment of the present invention, Figure 2 is a schematic structural view of a claw assembly provided by an embodiment of the present invention located in a stent, and Figure 3 is a schematic view of the embodiment of the present invention Schematic diagram of the structure of the claw assembly provided in the example. An embodiment of the present invention provides a stent delivery system, including:
推送芯丝10;Push the
支架20,环绕设置于部分所述推送芯丝10外,所述支架20具有若干网孔;A
至少一个卡爪组件30,位于所述推送芯丝10与所述支架20之间,所述卡爪组件30包括至少一个弹性件32及至少两个卡爪31,所述卡爪31及所述弹性件32均沿所述推送芯丝10的轴向套设于所述推送芯丝10上,所述弹性件32位于相邻两个所述卡爪31之间并连接两个所述卡爪31,所述卡爪31具有至少一个凸起部310,所述凸起部310沿所述推送芯丝10的径向朝背离所述推送芯丝10的方向延伸并卡入对应的所述网孔中,所述支架20在推送及回撤的过程中所述弹性件32始终处于拉伸状态,以使相邻两个所述卡爪31在所述弹性件32的作用下夹紧,进而抓紧所述网孔。At least one
通过在推送芯丝10与支架20之间设置卡爪31和弹性件32,所述支架20在推送及回撤的过程中所述弹性件32始终处于拉伸状态,以使相邻两个所述卡爪31在所述弹性件32的作用下夹紧,进而抓紧所述网孔,配合所述弹性件32的自伸缩调节避免了对局部网孔产生拉伸和挤压力,进而解决了支架20的网孔会因为受力而变形扩大,导致支架20容易出现打开不充分,不贴壁和无法回收的问题。By setting the
具体的,本实施例中,所述支架输送系统还包括微导管40,所述推送芯丝10及所述支架20均位于所述微导管40内,所述支架20已经通过特殊工艺方法压缩到所述微导管40的特定位置,所述支架20位于所述推送芯丝10的远端,通过驱动所述推送芯丝10在所述微导管40内移动,实现所述支架20的推送和回撤。例如,通过向远端推进所述推送芯丝10(可以同时回撤微导管40)使所述支架20释放(即向前伸出所述微导管40),所述支架20可进行自膨胀并在病变点处支撑血管,当所述支架20释放位置错误,不能完全打开或不能扩开血管时,可通过向近端回撤所述推送芯丝10(可以同时向远端推送微导管40)使所述支架20回收(即向后缩回所述微导管40)。Specifically, in this embodiment, the stent delivery system further includes a
所述支架20是一种特殊的植入物产品,由多种丝状可植入人体的金属或有机材料通过编织而成的圆筒状结构。从侧面看,编织而成的支架20是一种多孔型结构,这种结构能够使得支架20在植入血管病变处改变血液的流体动力学导向。一方面原有的动脉瘤的供血被支架20打断,动脉瘤的供血会逐步下降,这样动脉瘤会逐步萎缩,达到治愈的目的;另一方面,支架20提供了足够的支撑和脚手架的作用,内皮细胞可以顺着支架20攀爬并连接形成内皮组织,包裹住整个支架20,使得动脉瘤周围正常的血管壁不会因为血液流动的干扰而产生新的病变和远期血栓。The
所述支架20可采用能够自膨胀的支架,也可以借助其他外力进行展开,本申请对此不作任何限制。本实施例中,所述支架20为自膨胀支架。The
本实施例中,所述支架20为由柔性金属丝编织而成的网状结构。优选的,所述柔性金属丝的材质为镍钛诺、铂、铂-钨合金、不锈钢、钴-铬合金或钴-镍合金中的至少一种。In this embodiment, the
进一步的,所述支架20的内外壁均涂覆抗血栓的聚合物涂层,所述支架20的内外壁与聚合物涂层之间还覆盖有硅烷层,所述硅烷层与所述聚合物涂层通过共价键连接,通过采用与所述聚合物涂层共价键连接硅烷层能够进增强涂层在金属丝上的结合力。Further, the inner and outer walls of the
请继续参照图1,所述支架20的内部还设置有膨胀体50,所述膨胀体50固定在所述推送芯丝10上,初始状态下,所述膨胀体50压握于所述支架20内,当所述支架20展开后,所述膨胀体50进行自膨胀并用于对所述支架20的内壁进行按摩。也就是说,所述膨胀体50初始状态下位于微导管40内并随着所述支架20一起压握在所述推送芯丝10上的,当所述支架20展开后,所述膨胀体50不再被所述支架20束缚而进行自膨胀,由于所述膨胀体50位于所述支架20内,通过反复推送和回撤所述推送芯丝10,能够使所述膨胀体50在所述支架20的内部相对所述支架20移动,进而能够使所述膨胀体50按摩未能完全贴壁的支架20(即所述膨胀体50的外壁挤压所述支管的内壁),使所述支架20内的应力得以释放,从而保证所述支架20能够完全贴壁。Please continue to refer to FIG. 1, the inside of the
本实施例中,所述膨胀体50展开后的直径略小于或等于所述支架20的支架20的内径,以便于对所述支架20进行按摩。较佳的。所述膨胀体50自膨胀后的外壁与所述支架20展开后的内壁贴合。In this embodiment, the expanded diameter of the expanded
本实施例中,所述膨胀体50位于所述支架20的远端,应当理解的是,本申请对于所述膨胀体50的材质、形状及长度不作任何限制。In this embodiment, the
所述卡爪组件30的数量为至少一个,其数量的多少主要取决于所述支架20的长度,也就是说,当所述支架20的长度较长时,为更好的卡紧所述支架20以及防止所述支架20的局部受力不均,可沿所述支架20的轴向设置多个卡爪组件30,当然,本申请对于所述卡爪组件30的数量不作任何限制,可以是一个,也可以是多个。The number of the
同理,本申请对于所述卡爪组件30包含的卡爪31的数量也不做任何限制,一个卡爪组件30至少包含两个卡爪31,且对于相邻两个卡爪组件30之间的间距也不作任何限制。本实施例中,所述卡爪组件30为一个,所述卡爪组件30包含一个弹性件32及两个卡爪31。Similarly, the present application does not impose any limitation on the number of
较佳的,所述卡爪31可旋转地套设于所述推送芯丝10上。换言之,所述推送芯丝10扭转时,所述卡爪31保持不动。主要考虑到人体内的血管并非长直的,故所述推送芯丝10的运动轨迹也并非一条直线,通常需要进行弯曲或扭转,故通过使所述卡爪31可旋转地套设于所述推送芯丝10上,能够防止所述支架20跟随所述推送芯丝10进行扭转甚至变形,影响所述支架20的形态。本实施例中,所述卡爪31的孔径略大于所述推送芯丝10的直径,即可实现所述卡爪31可旋转地套设于所述推送芯丝10上。Preferably, the
请继续参照图1-图3,所述支架输送系统还包括固定在所述推送芯丝10上的至少一个限位件对,所述限位件对包括分别位于所述卡爪组件30两侧的两个第一限位件60,用于限制所述卡爪组件30中的两个卡爪31沿所述推送芯丝10的轴向移动。由于所述卡爪31可旋转地套设于所述推送芯丝10上,故可通过在所述卡爪组件30的两侧设置所述第一限位件60以防止所述卡爪31沿所述推送芯丝10的轴向移动,保证所述卡爪31的凸起部310能够稳固的卡入对应的所述网孔中。例如,两个所述第一限位件60例如包括分别位于所述卡爪组件30的远端侧的远端限位件及位于所述卡爪组件30的近端侧的近端限位件,其中所述远端限位件用于回撤支架20时限制远端侧的卡爪31向远端移动,所述近端限位件用于输送支架20时限制近端侧的卡爪向近端移动。Please continue to refer to FIGS. 1-3 , the stent delivery system further includes at least one pair of stoppers fixed on the pushing
可以理解的是,所述限位件对的数量应当与所述卡爪组件30的数量保持一致。本实施例,所述限位件对的数量为一个,即第一限位件60为两个。It can be understood that the number of the limiting member pairs should be consistent with the number of the
优选的,所述第一限位件60具有显影性,以便于医疗人员了解所述支架20近端的位置和可回收的极限位置。具体的,所述第一限位件60可采用显影性的材质制造而成或所述第一限位件60上涂抹有显影的材质。Preferably, the first limiting
请参照图4,在另一较佳的实施例中,所述支架输送系统还包括固定在所述推送芯丝10上的至少一个第二限位件61,所述第二限位件61位于所述卡爪组件30的远端侧以在回撤所述支架20时限制所述卡爪31向远端移动,所述推送芯丝10位于所述卡爪组件30的近端侧的区域设置一限位段62,所述限位段的直径大于所述卡爪31的内径以在输送所述支架20时限制所述卡爪31向近端移动。故此方式只需在所述卡爪组件30的单侧设置第二限位件61即可实现卡爪31的限位。Please refer to FIG. 4 , in another preferred embodiment, the stent delivery system further includes at least one second limiting
同理,所述第二限位件61也应具有显影性。Similarly, the second limiting
本实施例中,所述凸起部310沿所述推送芯丝10的径向朝背离所述推送芯丝10的方向延伸并卡入对应的所述网孔中,此处对应的意思可理解为所述凸起部310与所述网孔的位置是相对固定的。In this embodiment, the protruding
进一步的,所述卡爪31具有多个凸起部310,多个所述凸起部310沿所述推送芯丝10的周向分布。设置所述凸起部310的目的在于使所述卡爪31能够与所述支架20进行接触,并通过配合弹性件32的自伸缩性能使得支架20在推送和回撤的过程中所述支架20的网孔会被卡爪31稳固的抓住并夹紧,避免对局部网孔产生拉伸和挤压力,故可通过设置多个凸起部310能够与所述支架20连接的更加稳固。Further, the
本实施例中,所述凸起部310为4个,4个所述凸起部310沿所述推送芯丝10的周向分布,且两个所述凸起部310之间的夹角为90°。当然,本申请对于所述凸起部310的数量不作任何限制,也可以是一个,也可以是多个。In this embodiment, there are four
更进一步的,多个所述凸起部310沿所述推送芯丝10的周向均匀分布,以使所述支架20的受力均匀。同理,本申请对于所述凸起部310的分布方式也不作任何限制,可以是均匀分布,也可以是非均匀分布。Furthermore, the plurality of
更进一步的,所述卡爪31卡入所述网孔中的一端的尺寸与所述网孔的尺寸相适应,此处提及的相适应是指所述卡爪31的端部形状及尺寸以能够卡紧所述网孔为准,所述卡爪31的端部尺寸可以是相等、略大于或略小于所述网孔的孔径,只要不让网孔发生巨大变形即可。具体实施时,可根据所述网孔的形状对所述卡爪31的端部进行设计,例如所述网孔为菱形,所述卡爪31的端部也设计为方形或圆形,正好卡在所述菱形的中心,且所述卡爪31的端部的端面与所述菱形的四条边相接触,或者所述网孔也椭圆或圆形,则所述卡爪31的端部也设计为方形。当然,本申请对于网孔的尺寸及形状不作任何限制,对于所述卡爪31的端部尺寸及形状也不作任何限制。Furthermore, the size of the end of the
更进一步的,所述凸起部310卡入所述网孔中的一端具有倒圆边缘,也就是说,所述凸起部310的端部较为平滑,没有尖锐突出的棱角,以避免所述凸起部310划伤所述网孔或使所述网孔局部变形。Furthermore, the end of the
本实施例中,所述卡爪31的材质为金属或刚性聚合物,即所述卡爪31不易发生形变。In this embodiment, the
本实施例中,所述弹性件32为弹簧,当然,也可以采用其他具有弹性形变或者可拉伸的材质,本申请对此不作任何限制。所述弹簧的两端可通过焊接或者其他固定连接的方式与两个所述卡爪31进行连接。In this embodiment, the
请继续参照图1,所述推送芯丝10包括从远端到近端顺次设置的第一变径段、定径段及第二变径段,所述第一变径段及第二变径段的直径从远端到近端逐渐增大,所述定径段的直径保持不变,所述定径段的直径大于或等于所述第一变径段的最大直径且小于或等于所述第二变径段的最小直径,所述支架20环绕设置于所述第一变径段外。也就是说,所述推送芯丝10的远端的直径较小,而近端的直径较大,如此设计的目的在于使所述推送芯丝10的远端相对柔软而近端相对坚硬,以便于远端进行弯曲,而近端更容易使劲,进而使得所述推送芯丝10能够顺利的到达病变点。Please continue to refer to FIG. 1 , the pushing
本实施例中,所述推送芯丝10为一体成型结构,以保证所述推送芯丝10的各部分的力学性能一致。当然,所述推送芯丝10也可以采用分段连接的方式拼接形成,本申请对此不作任何限制。In this embodiment, the pushing
进一步的,所述定径段上套设有加固弹簧70。由于所述第一变径段外设置有卡爪组件30、第一限位件60等零部件,而所述第二变径段的直径相对较大,故所述定径段相比之下更容易发生局部弯折的情况,通过在所述定径段上套设加固弹簧70以增大所述定径段的抗弯折能力。Further, a reinforcing
更进一步的,所述加固弹簧70及所述第二变径段的外侧还套设有热缩管71。本实施例中,所述热缩管71位于所述推送芯丝10与所述微导管40之间,其材质为PTFE,作用在于减小所述推送芯丝10在推送和回撤过程中的阻力,同时避免刮伤所述微导管40的内壁。本实施例中是,所述热缩管71的端部与所述推送芯丝10固定连接,所述加固弹簧70通过所述热缩管71固定于所述推送芯丝10上。Furthermore, a heat-
请继续参照图1,所述推送芯丝10具有相对的近端及远端,所述远端套设有弹簧导丝80。本实施例中,所述第一变径段远离所述定径段的一端套设有弹簧导丝80。由于人体内血管存在很多分支,通过设置所述弹簧导丝80以防止所述推送芯丝10的远端直接接触并划伤血管壁。Please continue to refer to FIG. 1 , the pushing
进一步的,所述弹簧导丝80的端部朝远离所述推送芯丝10的方向向外弯折。Further, the end of the
更进一步的,所述弹簧导丝80的端部弯折的角度介于115°-145°之间。Furthermore, the bending angle of the end of the
请继续参照图1,所述近端设置有荧光标记90,用于提示医疗人员可以使用射线了。Please continue to refer to FIG. 1 , the proximal end is provided with a
应当理解的是,除本实施例中提及的推送芯丝10、支架20、卡爪组件30及微导管40等部件,本领域技术人员可如实际情况进行其它常规配置,本申请对此不再赘述。It should be understood that, except for the components such as the pushing
综上所述,本发明实施例提供了一种支架输送系统,包括:推送芯丝;支架,环绕设置于部分所述推送芯丝外,所述支架具有若干网孔;至少一个卡爪组件,位于所述推送芯丝与所述支架之间,所述卡爪组件包括至少一个弹性件及至少两个卡爪,所述卡爪及所述弹性件均沿所述推送芯丝的轴向套设于所述推送芯丝上,所述弹性件位于相邻两个所述卡爪之间并连接两个所述卡爪,所述卡爪具有至少一个凸起部,所述凸起部沿所述推送芯丝的径向朝背离所述推送芯丝的方向延伸并卡入对应的所述网孔中,所述支架在推送及回撤的过程中所述弹性件始终处于拉伸状态,以使相邻两个所述卡爪在所述弹性件的作用下夹紧,进而抓紧所述网孔。通过在推送芯丝与支架之间设置卡爪和弹性件,所述支架在推送及回撤的过程中所述弹性件始终处于拉伸状态,以使相邻两个所述卡爪在所述弹性件的作用下夹紧,进而抓紧所述网孔,配合所述弹性件的自伸缩调节避免了对局部网孔产生拉伸和挤压力,进而解决了支架的网孔会因为受力而变形扩大,导致支架容易出现打开不充分,不贴壁和无法回收的问题。To sum up, the embodiment of the present invention provides a stent delivery system, comprising: a pushing core wire; a stent arranged around a part of the pushing core wire, and the stent has several mesh holes; at least one claw assembly, Located between the pushing core wire and the bracket, the claw assembly includes at least one elastic member and at least two claws, the claw and the elastic member are both sleeved along the axial direction of the pushing core wire Provided on the pushing core wire, the elastic member is located between two adjacent claws and connects the two claws, the claw has at least one protruding portion, and the protruding portion is along the The radial direction of the pushing core wire extends away from the pushing core wire and snaps into the corresponding mesh, the elastic member is always in a stretched state during the pushing and retracting process of the stent, The two adjacent claws are clamped under the action of the elastic member, thereby grasping the mesh. By setting claws and elastic pieces between the pushing core wire and the stent, the elastic piece is always in a stretched state during the pushing and retracting process of the stent, so that two adjacent claws are in the Clamp under the action of the elastic member, and then grasp the mesh, cooperate with the self-stretching adjustment of the elastic member to avoid stretching and squeezing force on the local mesh, and then solve the problem that the mesh of the bracket will be deformed due to force. The expansion of the deformation causes the stent to be prone to problems of insufficient opening, non-adhesion to the wall and failure to recycle.
上述描述仅是对本发明较佳实施例的描述,并非对本发明范围的任何限定,本发明领域的普通技术人员如上述揭示内容做的任何变更、修饰,均属于权利要求书的保护范围。The above description is only a description of the preferred embodiments of the present invention, not any limitation to the scope of the present invention. Any changes and modifications made by those of ordinary skill in the field of the present invention as disclosed above shall fall within the protection scope of the claims.
Claims (19)
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