技术领域Technical Field
本发明涉及医疗器械领域，进一步地涉及一种覆膜支架及覆膜方法。The present invention relates to the field of medical devices, and further to a coated stent and a coating method.
背景技术Background Art
动脉瘤是常见的心脑血管疾病，一旦破裂则致死率极高。较大的动脉瘤破裂的风险更高，已破裂的动脉瘤即使保守治疗，稳定后再破裂的风险也较大，这类动脉瘤通常起病急，病程短，易造成不良预后。形成动脉瘤的病因较多，多与动脉硬化、高血压、肌纤维发育不良、免疫因素、遗传因素等相关，目前其发病机制尚不完全明确。针对动脉瘤的治疗方面尚没有完全统一的认识，内科治疗是基础，对于动脉瘤的处理主要包括外科手术夹闭动脉瘤和介入手术腔内治疗。外科手术风险较高，创伤较大，并发症较多，随着介入技术的发展，支架的出现使介入治疗颅内动脉瘤的疗效大大提高。Aneurysms are common cardiovascular and cerebrovascular diseases, and once ruptured, the mortality rate is extremely high. Larger aneurysms have a higher risk of rupture. Even if a ruptured aneurysm is treated conservatively, the risk of rupture again after stabilization is also high. This type of aneurysm usually has an acute onset and a short course, which can easily lead to a poor prognosis. There are many causes of aneurysm formation, most of which are related to arteriosclerosis, hypertension, fibromuscular dysplasia, immune factors, genetic factors, etc., and its pathogenesis is not yet fully understood. There is no completely unified understanding of the treatment of aneurysms. Medical treatment is the basis. The treatment of aneurysms mainly includes surgical clipping of aneurysms and interventional intracavitary treatment. Surgical operations have higher risks, greater trauma, and more complications. With the development of interventional technology, the emergence of stents has greatly improved the efficacy of interventional treatment of intracranial aneurysms.
目前临床上主要的支架技术包括，支架辅助弹簧圈栓塞术、血流导向装置置入术和覆膜支架置入术。支架辅助弹簧圈栓塞可以改变动脉瘤颈处的血流动力学状态、改变载瘤动脉曲度、起到血管内皮生长的“脚手架”的作用。血流导向装置可以改变动脉内血流动力学状态诱发动脉瘤内血栓形成。覆膜支架可以隔绝动脉瘤内血流诱发瘤内血栓形成。不过，现有技术的血管支架仍具有一些缺陷。At present, the main stent technologies in clinical practice include stent-assisted coil embolization, blood flow guidance device implantation, and covered stent implantation. Stent-assisted coil embolization can change the hemodynamic state at the neck of the aneurysm, change the curvature of the tumor-bearing artery, and act as a "scaffold" for the growth of vascular endothelium. The blood flow guidance device can change the hemodynamic state in the artery and induce thrombosis in the aneurysm. The covered stent can isolate the blood flow in the aneurysm and induce thrombosis in the tumor. However, the existing vascular stents still have some defects.
在支架辅助弹簧圈栓塞介入手术过程中，需要通过微导管穿越支架网眼输送弹簧圈来填塞动脉瘤腔，微导管穿过支架空隙的难度很大、而且由于操作时易穿破血管组织而导致风险较高，而且成本也较高。动脉瘤栓塞术后存在延迟闭塞、复发、破裂风险。血流导向装置置入术中，为改变动脉内血流诱发动脉瘤内血栓形成，希望支架具有较高的金属覆盖率，血管支架的金属覆盖率是指支架中的金属覆盖面积占支架总面积的比例。目前临床上可以选择使用金属覆盖率35％左右的Pipeline支架进行介入治疗。然而，支架金属覆盖率越高也会存在一系列问题：1、覆盖率越高，径向张力越高，顺应性变差；2、覆盖率高可能会妨碍甚至阻塞周边血管的血流，而对患者造成额外伤害；3、覆盖率高的情况下，动脉瘤近端的血压很大，支架的网孔在血流的持续冲刷下容易发生动脉瘤破裂出血。如果采用全覆膜型支架，虽然可以隔绝动脉瘤内的血流，但是其存在覆盖血管其它穿支动脉而阻碍正常血流的风险，并且全覆膜支架具有高的剖面特征，使支架输送困难，难于到达病变部位，适用范围具有局限性。During the stent-assisted coil embolization interventional procedure, it is necessary to deliver coils through the stent mesh to fill the aneurysm cavity through a microcatheter. It is very difficult for the microcatheter to pass through the stent gap, and it is easy to penetrate the vascular tissue during operation, resulting in a high risk and high cost. There is a risk of delayed occlusion, recurrence, and rupture after aneurysm embolization. During the blood flow guidance device implantation, in order to change the blood flow in the artery to induce thrombosis in the aneurysm, it is hoped that the stent has a high metal coverage rate. The metal coverage rate of the vascular stent refers to the proportion of the metal coverage area in the stent to the total area of the stent. At present, clinically, Pipeline stents with a metal coverage rate of about 35% can be selected for interventional treatment. However, the higher the metal coverage rate of the stent, the higher the radial tension and the worse the compliance; 2. A high coverage rate may hinder or even block the blood flow of the surrounding blood vessels, causing additional harm to the patient; 3. When the coverage rate is high, the blood pressure at the proximal end of the aneurysm is very high, and the mesh of the stent is prone to aneurysm rupture and bleeding under the continuous flushing of the blood flow. If a fully covered stent is used, although the blood flow in the aneurysm can be isolated, there is a risk of covering other perforating arteries of the blood vessel and obstructing normal blood flow. In addition, the fully covered stent has a high profile feature, which makes the stent difficult to deliver and difficult to reach the lesion site, and its scope of application is limited.
综上所述，针对较大的动脉瘤并临近重要分支血管的病变血管，为避免动脉瘤延迟闭塞、复发甚至破裂，需要开发一种更易输送、更安全的血管内治疗植入物。In summary, for larger aneurysms and diseased blood vessels adjacent to important branch vessels, in order to avoid delayed aneurysm occlusion, recurrence, or even rupture, it is necessary to develop an easier-to-deliver and safer intravascular treatment implant.
发明内容Summary of the invention
针对上述技术问题，本发明的目的在于提供一种覆膜支架及覆膜方法，所述覆膜支架的覆膜位于支架主体的中间段靠近流入段的一端，能够对动脉瘤开口的近心端进行封堵，能够防止或减小血管内的血流进入动脉瘤，以有利于动脉瘤的修复。In view of the above technical problems, the object of the present invention is to provide a coated stent and a coating method, wherein the coating of the coated stent is located at one end of the middle section of the stent body close to the inflow section, which can block the proximal end of the aneurysm opening, prevent or reduce the blood flow in the blood vessel from entering the aneurysm, so as to facilitate the repair of the aneurysm.
为了实现上述目的，本发明提供一种覆膜支架，包括：In order to achieve the above object, the present invention provides a stent graft, comprising:
支架主体，包括流入段、流出段以及位于所述流入段和所述流出段之间的中间段，血流能够自所述流入段流入，通过所述中间段后，经所述流出段流出；The stent body comprises an inflow section, an outflow section and an intermediate section located between the inflow section and the outflow section, and blood can flow into the inflow section, pass through the intermediate section, and then flow out through the outflow section;
覆膜，所述覆膜环绕安装于所述支架主体的所述中间段靠近所述流入段的一端，对应动脉瘤开口的近心端。The coating is installed around the middle section of the stent body and one end close to the inflow section, corresponding to the proximal end of the aneurysm opening.
在本发明的一些优选实施例中，所述覆膜的长度大于动脉瘤开口长度的一半，小于动脉瘤开口的长度。In some preferred embodiments of the present invention, the length of the coating is greater than half of the length of the aneurysm opening and less than the length of the aneurysm opening.
在本发明的一些优选实施例中，所述支架主体是自膨胀式支架。In some preferred embodiments of the present invention, the stent body is a self-expanding stent.
在本发明的一些优选实施例中，所述支架主体采用形状记忆材料制作而成。In some preferred embodiments of the present invention, the stent body is made of shape memory material.
在本发明的一些优选实施例中，所述覆膜通过缝合，或粘结，或静电纺丝的方式安装于所述支架主体的所述中间段。In some preferred embodiments of the present invention, the coating is installed on the middle section of the stent body by suturing, bonding, or electrospinning.
在本发明的一些优选实施例中，所述覆膜是单层膜，安装于所述支架主体的内侧或外侧。In some preferred embodiments of the present invention, the coating is a single-layer film installed on the inner side or the outer side of the stent body.
在本发明的一些优选实施例中，所述覆膜包括内层覆膜和外层覆膜，所述内层覆膜安装于所述支架主体的内壁，所述外层覆膜安装于所述支架主体的外壁。In some preferred embodiments of the present invention, the coating includes an inner coating and an outer coating, the inner coating is installed on the inner wall of the stent body, and the outer coating is installed on the outer wall of the stent body.
在本发明的一些优选实施例中，所述内层覆膜的材料是经过生物修饰或携带功能性药物的不可降解高分子；所述外层覆膜的材料是不可降解高分子材料。In some preferred embodiments of the present invention, the material of the inner coating is a non-degradable polymer that has been bio-modified or carries functional drugs; the material of the outer coating is a non-degradable polymer material.
在本发明的一些优选实施例中，所述覆膜支架还包括显影标识，所述显影标识包括支架显影标识件和覆膜显影标识件，其中所述支架显影标识件安装于所述支架主体，用于标识所述支架主体的位置，所述覆膜显影标识件安装于所述覆膜和所述支架主体的连接处。In some preferred embodiments of the present invention, the coated stent also includes a developing mark, which includes a stent developing mark and a coating developing mark, wherein the stent developing mark is installed on the stent body to mark the position of the stent body, and the coating developing mark is installed at the connection between the coating and the stent body.
在本发明的一些优选实施例中，所述支架显影标识件和所述覆膜显影标识件由黄金、铂金、PTW合金或PtIr合金中的一种或多种的组合制作而成。In some preferred embodiments of the present invention, the stent development identification element and the coating development identification element are made of a combination of one or more of gold, platinum, PTW alloy or PtIr alloy.
根据本发明的另一方面，本发明进一步提供一种覆膜方法，包括：According to another aspect of the present invention, the present invention further provides a coating method, comprising:
在覆膜支架处于收缩状态时，控制覆膜支架进入具有动脉瘤的血管，并使得支架主体的中间段靠近流入段的一端对应动脉瘤开口的近心端；When the stent graft is in a contracted state, the stent graft is controlled to enter the blood vessel with the aneurysm, and one end of the middle section of the stent body close to the inflow section corresponds to the proximal end of the aneurysm opening;
允许所述覆膜支架切换至扩张状态，借由所述支架主体撑开位于所述支架主体的所述中间段靠近所述流入段的覆膜，使得所述覆膜覆盖所述动脉瘤开口的近心端。The coated stent is allowed to switch to an expanded state, and the coating located in the middle section of the stent body close to the inflow section is stretched open by the stent body, so that the coating covers the proximal end of the aneurysm opening.
本发明所提供的所述覆膜支架具有以下至少一个有益效果：The stent graft provided by the present invention has at least one of the following beneficial effects:
1、本发明所提供的所述覆膜支架的覆膜覆盖于支架主体的中间段靠近流入段的一端，能够覆盖于动脉瘤开口的近心端，从而能够进一步防止或减少血管中的血液流入动脉瘤，提高动脉瘤愈合的效率。1. The coating of the coated stent provided by the present invention covers one end of the middle section of the stent body close to the inflow section, and can cover the proximal end of the aneurysm opening, thereby further preventing or reducing the blood in the blood vessel from flowing into the aneurysm and improving the efficiency of aneurysm healing.
2、本发明所提供的所述覆膜支架通过在所述支架主体的所述中间段靠近所述流入段的一端设置所述覆膜，并且所述覆膜对应覆盖动脉瘤开口的近心端，从而能够减小所述支架主体所受到的压强大小，提高植入物整体的耐疲劳性，避免所述支架主体破损和动脉瘤破裂。并且，植入所述覆膜的部分能够采用金属覆盖率较低的支架主体，以提高植入物的顺应性。2. The stent graft provided by the present invention is provided with the coating at one end of the middle section of the stent body close to the inflow section, and the coating corresponds to the proximal end of the aneurysm opening, thereby reducing the pressure on the stent body, improving the fatigue resistance of the implant as a whole, and avoiding damage to the stent body and rupture of the aneurysm. In addition, the part implanted with the coating can adopt a stent body with a lower metal coverage rate to improve the compliance of the implant.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
下面将以明确易懂的方式，结合附图说明优选实施方式，对本发明的上述特性、技术特征、优点及其实现方式予以进一步说明。The preferred implementation modes will be described below in a clear and understandable manner with reference to the accompanying drawings to further illustrate the above-mentioned characteristics, technical features, advantages and implementation methods of the present invention.
图1是本发明的优选实施例的覆膜支架的立体图；FIG1 is a perspective view of a stent graft according to a preferred embodiment of the present invention;
图2是本发明的优选实施例的覆膜支架的局部立体图；FIG2 is a partial stereoscopic view of a stent graft according to a preferred embodiment of the present invention;
图3是血管内未植入支架时血液流动示意图；FIG3 is a schematic diagram of blood flow in a blood vessel when no stent is implanted;
图4是本发明的优选实施例的覆膜支架放入血管后的血流示意图；FIG4 is a schematic diagram of blood flow after the stent graft is placed in a blood vessel according to a preferred embodiment of the present invention;
图5是本发明的优选实施例的覆膜支架放入血管后的局部示意图；FIG5 is a partial schematic diagram of a stent graft after being placed into a blood vessel according to a preferred embodiment of the present invention;
图6是支架放入血管后动脉瘤的修复过程示意图；FIG6 is a schematic diagram of the repair process of an aneurysm after the stent is placed in a blood vessel;
图7是晚期动脉瘤的血流流动示意图；FIG7 is a schematic diagram of blood flow in an advanced aneurysm;
图8是早期动脉瘤的血流流动示意图。FIG. 8 is a schematic diagram of blood flow in an early stage aneurysm.
附图标号说明：Description of Figure Numbers:
1支架主体，2覆膜，3显影标识，11流入段，12中间段，13流出段，31支架显影标识件，32覆膜显影标识件，x血管，d动脉瘤，z分支血管。1 stent body, 2 coating, 3 development marker, 11 inflow segment, 12 middle segment, 13 outflow segment, 31 stent development marker, 32 coating development marker, x blood vessel, d aneurysm, z branch blood vessel.
具体实施方式DETAILED DESCRIPTION
为了更清楚地说明本发明实施例或现有技术中的技术方案，下面将对照附图说明本发明的具体实施方式。显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图，并获得其他的实施方式。In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the specific implementation methods of the present invention will be described below with reference to the accompanying drawings. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings and other implementation methods can be obtained based on these drawings without creative work.
为使图面简洁，各图中只示意性地表示出了与发明相关的部分，它们并不代表其作为产品的实际结构。另外，以使图面简洁便于理解，在有些图中具有相同结构或功能的部件，仅示意性地绘示了其中的一个，或仅标出了其中的一个。在本文中，“一个”不仅表示“仅此一个”，也可以表示“多于一个”的情形。In order to simplify the drawings, only the parts related to the invention are schematically shown in each figure, and they do not represent the actual structure of the product. In addition, in order to simplify the drawings and facilitate understanding, in some figures, only one of the parts with the same structure or function is schematically drawn or marked. In this article, "one" not only means "only one", but also means "more than one".
还应当进一步理解，在本申请说明书和所附权利要求书中使用的术语“和/或”是指相关联列出的项中的一个或多个的任何组合以及所有可能组合，并且包括这些组合。It should be further understood that the term “and/or” used in the specification and appended claims refers to any combination and all possible combinations of one or more of the associated listed items, and includes these combinations.
在本文中，需要说明的是，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本发明中的具体含义。In this document, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.
另外，在本申请的描述中，术语“第一”、“第二”等仅用于区分描述，而不能理解为指示或暗示相对重要性。In addition, in the description of the present application, the terms "first", "second", etc. are only used to distinguish the description and cannot be understood as indicating or implying relative importance.
实施例1Example 1
参考说明书附图1至图7，本发明提供一种覆膜支架，所述覆膜支架的支架主体的中间段覆膜，并且所述覆膜位于中间段靠近流入段的一端，能够在使用过程中封堵血管瘤与血管连通的开口的近心端部分，能够进一步阻止或减少动脉瘤区域的血流流入，以有利于实现治愈。With reference to Figures 1 to 7 of the specification, the present invention provides a coated stent, wherein the middle section of the stent body of the coated stent is coated, and the coating is located at one end of the middle section close to the inflow section, which can block the proximal end of the opening connecting the hemangioma and the blood vessel during use, and can further prevent or reduce the blood flow inflow into the aneurysm area, so as to facilitate healing.
参考说明书附图1和图2，具体地，所述覆膜支架包括支架主体1和覆膜2，其中所述支架主体1包括流入段11、中间段12以及流出段13，所述中间段12位于所述流入段11和所述流出段13之间，当所述覆膜支架安装于血管内时，血管内的血液能够自所述流入段11进入，经过所述中间段12后，自所述流出段13流出。所述覆膜2安装于所述支架主体1的所述中间段12。Referring to Figures 1 and 2 of the specification, specifically, the stent graft comprises a stent body 1 and a coating 2, wherein the stent body 1 comprises an inflow section 11, a middle section 12 and an outflow section 13, the middle section 12 is located between the inflow section 11 and the outflow section 13, and when the stent graft is installed in a blood vessel, blood in the blood vessel can enter from the inflow section 11, pass through the middle section 12, and then flow out from the outflow section 13. The coating 2 is installed in the middle section 12 of the stent body 1.
所述支架主体1具有压握状态和扩张状态，在所述压握状态，所述支架主体1收缩，能够被装入输送装置被输送至包含动脉瘤结构的血管中；在所述支架主体1被输送至血管中的预设位置后，输送装置与所述覆膜支架相分离，作用于所述支架主体1的束缚力消失，所述支架主体1逐渐张开，体积膨胀至所述扩张状态，并撑开所述覆膜2。The stent body 1 has a clamped state and an expanded state. In the clamped state, the stent body 1 contracts and can be loaded into a delivery device and delivered to a blood vessel containing an aneurysm structure. After the stent body 1 is delivered to a preset position in the blood vessel, the delivery device is separated from the coated stent, the restraining force acting on the stent body 1 disappears, the stent body 1 gradually opens, and its volume expands to the expanded state, and the coating 2 is stretched open.
进一步地，所述覆膜2安装于所述中间段12靠近所述流入段11的一端。所述中间段12的长度对应动脉瘤d与血管x连通的开口的尺寸，所述覆膜2的长度小于所述中间段12的长度。Furthermore, the coating 2 is installed at one end of the middle section 12 close to the inflow section 11. The length of the middle section 12 corresponds to the size of the opening connecting the aneurysm d and the blood vessel x, and the length of the coating 2 is less than that of the middle section 12.
具体地，当所述覆膜支架安装于具有动脉瘤d的血管x时，所述支架主体1的所述中间段12对应动脉瘤开口，所述中间段12靠近所述流入段11的一端对应动脉瘤开口的近心端，所述中间段12靠近所述流出段13的一端对应动脉瘤开口的远心端。被处于扩张状态的所述支架主体1撑开的所述覆膜2能够封堵动脉瘤开口的近心端，阻止或减少血管内的血液自动脉瘤开口的近心端流入动脉瘤，以提高动脉瘤的愈合效率。Specifically, when the stent graft is installed in a blood vessel x having an aneurysm d, the middle section 12 of the stent body 1 corresponds to the aneurysm opening, the end of the middle section 12 close to the inflow section 11 corresponds to the proximal end of the aneurysm opening, and the end of the middle section 12 close to the outflow section 13 corresponds to the distal end of the aneurysm opening. The graft 2, which is stretched open by the stent body 1 in the expanded state, can block the proximal end of the aneurysm opening, prevent or reduce the blood in the blood vessel from flowing into the aneurysm from the proximal end of the aneurysm opening, so as to improve the healing efficiency of the aneurysm.
需要指出的是，其中所述动脉瘤开口的近心端指的是靠近心脏的一端，所述远心端指的是远离心脏的一端。在血管内，血液由所述近心端向所述远心端流动。It should be noted that the proximal end of the aneurysm opening refers to the end close to the heart, and the distal end refers to the end far from the heart. In the blood vessel, blood flows from the proximal end to the distal end.
参考说明书附图6，在未向具有动脉瘤的血管内植入支架时，血管内的血液自动脉瘤开口的远心端进入动脉瘤，在动脉瘤内形成涡流，然后经过动脉瘤开口的近心端离开动脉瘤。6 of the specification, when a stent is not implanted in a blood vessel with an aneurysm, blood in the blood vessel enters the aneurysm from the distal end of the aneurysm opening, forms a vortex in the aneurysm, and then leaves the aneurysm through the proximal end of the aneurysm opening.
参考说明书附图6，在向具有动脉瘤的血管中植入支架后，血管内的血液进入动脉瘤的量即刻减少，只有小的涡流存在，并且血流大部分从动脉瘤开口的近心端流入。6 of the specification, after a stent is implanted in a blood vessel with an aneurysm, the amount of blood in the blood vessel entering the aneurysm is immediately reduced, only a small vortex exists, and most of the blood flow flows in from the proximal end of the aneurysm opening.
参考说明书附图6，在向具有动脉瘤的血管中植入支架一段时间之后，动脉瘤几乎被血栓充满，血流流入量进一步减少，只在瘤颈口残留少量血流。6 of the specification, after a period of time after a stent is implanted in a blood vessel with an aneurysm, the aneurysm is almost filled with thrombus, and the blood flow is further reduced, with only a small amount of blood flow remaining at the neck of the aneurysm.
参考说明书附图6，再经过一段时间之后，动脉瘤几乎被完全吸收、愈合，血管完成重建。Referring to Figure 6 of the specification, after a period of time, the aneurysm is almost completely absorbed and healed, and the blood vessel reconstruction is completed.
由上述植入支架后血管与动脉瘤之间的流动可知，在具有动脉瘤的血管中植入支架后，血管中的血液进入动脉瘤的方式由动脉瘤开口的远心端变为近心端。本发明中将所述覆膜2设置在所述支架主体1的所述中间段12对应动脉瘤开口近心端的位置，从而能够进一步阻止或减少血管内的血流自动脉瘤开口的近心端流入动脉瘤，加快动脉瘤的闭塞和修复。It can be seen from the flow between the blood vessel and the aneurysm after the stent is implanted that after the stent is implanted in the blood vessel with the aneurysm, the way in which the blood in the blood vessel enters the aneurysm changes from the distal end of the aneurysm opening to the proximal end. In the present invention, the coating 2 is arranged at the position of the middle section 12 of the stent body 1 corresponding to the proximal end of the aneurysm opening, so as to further prevent or reduce the blood flow in the blood vessel from flowing into the aneurysm from the proximal end of the aneurysm opening, thereby accelerating the occlusion and repair of the aneurysm.
参考说明书附图7和图8，对于宽瘤颈和大口径流入是支架治疗未破裂侧壁动脉瘤延迟闭塞的潜在因素，在支架植入六个月后，晚期和早期闭塞动脉对比见图。箭头表示流向动脉瘤内的血流。动脉瘤开口处椭圆形1区域和2区域分别代表向内和向外血流区域。图7表示晚期闭塞动脉瘤，显示了明显的瘤囊尺寸、高度、几何形状的开口和近端瘤颈(1区域)的高流入量；图8表示早期闭塞动脉瘤，显示较小的瘤囊尺寸、高度、几何形状和瘤颈血流动力学改变，以及远端瘤颈(2区域)流入。由此可见，对于晚期闭塞的动脉瘤，在支架(血流导向装置)覆盖动脉瘤开口的近心端进行覆膜，可减少近心端动脉瘤开口的血液流入量，加快动脉瘤的闭塞，同时，还会降低由于血流在动脉瘤开口的近端持续进入而引起动脉瘤破裂的风险。Referring to Figures 7 and 8 of the specification, wide aneurysm neck and large-caliber inflow are potential factors for delayed occlusion of unruptured sidewall aneurysms treated with stents. Six months after stent implantation, the comparison of late and early occluded arteries is shown in the figure. Arrows indicate blood flow into the aneurysm. Elliptical areas 1 and 2 at the aneurysm opening represent the inward and outward blood flow areas, respectively. Figure 7 shows a late-stage occluded aneurysm, showing obvious aneurysm sac size, height, geometric opening and high inflow in the proximal aneurysm neck (area 1); Figure 8 shows an early-stage occluded aneurysm, showing smaller aneurysm sac size, height, geometry and hemodynamic changes in the aneurysm neck, as well as inflow in the distal aneurysm neck (area 2). It can be seen that for late-stage occluded aneurysms, coating the proximal end of the aneurysm opening covered by the stent (blood flow guiding device) can reduce the blood inflow into the proximal aneurysm opening, accelerate the occlusion of the aneurysm, and at the same time, reduce the risk of aneurysm rupture caused by continuous blood flow entering the proximal end of the aneurysm opening.
优选地，所述覆膜2的长度大于动脉瘤开口的宽度的一半，并且小于动脉瘤开口的宽度。需要指出的是，根据动脉瘤开口的宽度的不同，所述覆膜2的长度能够被实施为不同的数值。Preferably, the length of the coating 2 is greater than half of the width of the aneurysm opening and less than the width of the aneurysm opening. It should be noted that the length of the coating 2 can be implemented as different values according to the width of the aneurysm opening.
还需要指出的是，所述支架主体1内部中空，整体呈管状并具有圆形的截面。可选地，所述支架主体1为自膨胀式支架，采用镍钛合金或其他具有形状记忆特性的生物相容材料制成，也可以选择可弹性或可塑性变形的材料，如球囊可扩张的材料。加工工艺可以为管材激光切割、丝线编织或焊接，后续进行热处理定型而成，所述支架主体1热定型后为网状结构，所述支架主体1的径向力可以通过调整切割管材的厚度、编织用丝线的直径来进行调节。所述支架主体1的顺应性能可以通过调节支架的网状结构来进行优化。采用形状记忆合金所制备的所述支架主体1具有很好的可压缩性能，能够将支架直径压小以进入较小的血管中。当输送覆膜支架达到病灶部位时，能实现自膨胀释放至未受压缩前的形状，因此在进行血管重建时，只需根据待治疗血管瘤的具体情况，选择长度直径合适的覆膜支架植入动脉血管即可，覆膜支架到达病灶部位后不再需要球囊扩张的步骤，操作方便。进一步，所述支架主体1优选为编织结构，例如可由8至256根编织丝编织而成，优选编织丝介于12～64根之间。所述支架主体1的所述中间段12用于与所述动脉血管壁之间形成供血腔。所述流入段11和流出段12的直径为2-6mm，总长度为18-42mm。所述支架可以为直筒型(流入段11、流出段13和中间段12等径)，也可以为沙漏型(流入段11和流出段13的直径大于中间段12)，对此，本发明不做特殊的限定。It should also be pointed out that the stent body 1 is hollow inside, tubular as a whole and has a circular cross-section. Optionally, the stent body 1 is a self-expanding stent, made of nickel-titanium alloy or other biocompatible materials with shape memory properties, or materials that can be elastically or plastically deformed, such as balloon-expandable materials. The processing technology can be laser cutting of the tube, weaving or welding of silk threads, and then heat treatment and shaping. The stent body 1 is a mesh structure after heat shaping, and the radial force of the stent body 1 can be adjusted by adjusting the thickness of the cut tube and the diameter of the weaving silk thread. The compliance of the stent body 1 can be optimized by adjusting the mesh structure of the stent. The stent body 1 made of shape memory alloy has good compressibility and can reduce the diameter of the stent to enter smaller blood vessels. When the transported covered stent reaches the lesion site, it can achieve self-expansion and release to the shape before compression. Therefore, when performing vascular reconstruction, it is only necessary to select a covered stent with a suitable length and diameter to be implanted into the arterial blood vessel according to the specific situation of the hemangioma to be treated. After the covered stent reaches the lesion site, the balloon expansion step is no longer required, and the operation is convenient. Further, the stent body 1 is preferably a braided structure, for example, it can be woven from 8 to 256 braided wires, and preferably the braided wires are between 12 and 64. The middle section 12 of the stent body 1 is used to form a blood supply cavity with the arterial blood vessel wall. The diameter of the inflow section 11 and the outflow section 12 is 2-6mm, and the total length is 18-42mm. The stent can be a straight-cylinder type (the inflow section 11, the outflow section 13 and the middle section 12 are of equal diameter), or an hourglass type (the diameter of the inflow section 11 and the outflow section 13 is greater than the middle section 12), and the present invention does not make any special restrictions on this.
优选地，在本优选实施例中，所述覆膜2包括内层覆膜和外层覆膜。Preferably, in this preferred embodiment, the coating 2 includes an inner coating and an outer coating.
优选地，所述内层覆膜的材料可以为膨体形态的聚四氟乙烯(ePTFE)；或经过生物修饰或携带功能性药物的不可降解高分子及其聚合物，如聚氨酯(PU)、聚苯二甲酸乙二醇酯(PET)、聚四氟乙烯聚合物(PTFE)等；或可降解高分子材料，如聚乳酸(PLLA或DLPLA)、乳酸-羟基乙酸共聚物(PLGA)、聚乙醇酸、聚乙交酯、聚丙交酯、聚己内酯、聚乙醇酸等；或相关共聚物或天然聚合物，如胶原蛋白、明胶、壳聚糖、纤维蛋白原等。由于内层覆膜具有低的表面能，内层覆膜与血液接触具有良好的血液相容性，可有效减少血栓形成，能够形成通畅的血流通道。Preferably, the material of the inner coating can be expanded polytetrafluoroethylene (ePTFE); or non-degradable polymers and polymers thereof that have been bio-modified or carry functional drugs, such as polyurethane (PU), polyethylene terephthalate (PET), polytetrafluoroethylene polymer (PTFE), etc.; or degradable polymer materials, such as polylactic acid (PLLA or DLPLA), lactic acid-glycolic acid copolymer (PLGA), polyglycolic acid, polyglycolide, polylactide, polycaprolactone, polyglycolic acid, etc.; or related copolymers or natural polymers, such as collagen, gelatin, chitosan, fibrinogen, etc. Since the inner coating has a low surface energy, the inner coating has good blood compatibility in contact with blood, can effectively reduce thrombosis, and can form an unobstructed blood flow channel.
优选地，所述外层覆膜的材料可以选用不可降解高分子材料，如聚氨酯(PU)、聚苯二甲酸乙二醇酯(PET)、聚四氟乙烯(PTFE)等；也可以选用可降解高分子材料，如聚乙交酯、聚丙交酯、聚己内酯、聚乙醇酸等；也可以选用相关共聚物或者天然聚合物，如胶原蛋白、明胶、壳聚糖、纤维蛋白原等。所述外层覆膜的外表面为易促进内皮化的生物性膜材，可以诱发动脉瘤内或出血部分的血栓形成，促使动脉瘤快速激化缩小，减小体内占位效应；同时有效黏附内皮细胞和细胞分化，增殖加速血管病变部分内皮化，能更有效地治疗动脉瘤等血管疾病。Preferably, the material of the outer coating can be selected from non-degradable polymer materials, such as polyurethane (PU), polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), etc.; it can also be selected from degradable polymer materials, such as polyglycolide, polylactide, polycaprolactone, polyglycolic acid, etc.; it can also be selected from related copolymers or natural polymers, such as collagen, gelatin, chitosan, fibrinogen, etc. The outer surface of the outer coating is a biological membrane material that is easy to promote endothelialization, which can induce thrombosis in the aneurysm or bleeding part, promote the rapid intensification and shrinkage of the aneurysm, and reduce the space-occupying effect in the body; at the same time, it effectively adheres to endothelial cells and cell differentiation, and accelerates the proliferation of endothelialization of the vascular lesion part, which can more effectively treat vascular diseases such as aneurysms.
需要指出的是，在本发明的另一些优选实施例中，所述覆膜2还能够被实施为单层结构，即仅包括所述内层覆膜，或仅包括所述外层覆膜。It should be pointed out that, in some other preferred embodiments of the present invention, the coating 2 can also be implemented as a single-layer structure, that is, only including the inner coating layer, or only including the outer coating layer.
优选地，所述覆膜2和所述支架主体1之间可以采用缝合、粘合、静电纺丝等方式结合在一起。对此本发明不做限定。Preferably, the coating 2 and the stent body 1 can be combined together by suturing, bonding, electrostatic spinning, etc. The present invention is not limited to this.
进一步地，所述覆膜支架进一步包括显影标识3，所述显影标识3包括支架显影标识件(图中未示出)和覆膜显影标识件32，所述支架显影标识件安装于所述支架主体1，用于标识所述支架主体1在血管中的位置和总长度；所述覆膜显影标识件32安装于所述覆膜2与所述支架主体1之间的连接位置，用于标识所述覆膜2在血管中的位置，确保所述覆膜2能够覆盖动脉瘤开口的近心端，同时避免所述覆膜2覆盖分支血管z。Furthermore, the coated stent further includes a development mark 3, which includes a stent development mark (not shown in the figure) and a coating development mark 32. The stent development mark is installed on the stent body 1 to mark the position and total length of the stent body 1 in the blood vessel; the coating development mark 32 is installed at the connection position between the coating 2 and the stent body 1 to mark the position of the coating 2 in the blood vessel, ensuring that the coating 2 can cover the proximal end of the aneurysm opening, while preventing the coating 2 from covering the branch blood vessel z.
优选地，所述支架显影标识件可选用黄金、钽、铂金、PtW合金或PtIr合金等材料制作而成。所述支架显影标识件1是包裹所述支架主体1的合金环。可选地，所述支架显影标识件1还能够是合金丝状缠绕所述支架主体1编织而成，本发明对所述支架显影标识件1的具体结构不做特殊的显影。Preferably, the stent development identification member can be made of gold, tantalum, platinum, PtW alloy or PtIr alloy. The stent development identification member 1 is an alloy ring that wraps the stent body 1. Optionally, the stent development identification member 1 can also be woven by wrapping the stent body 1 in an alloy wire shape. The present invention does not make any special development on the specific structure of the stent development identification member 1.
优选地，所述覆膜显影标识件32可选用黄金、钽、铂金、PtW合金或PtIr合金等材料制作而成。所述覆膜显影标识件32位于所述覆膜2与所述支架主体1的连接处，也就是说，所述覆膜显影标识件32位于所述覆膜2的边界位置。所述覆膜标识件通过显影丝缠绕所述支架主体1形成，或者通过显影丝包裹所述支架主体1的一端或者几段形成，或者通过显影环焊接在所述支架主体1上形成，用于标识所述覆膜2的精确位置。Preferably, the coating developing identification part 32 can be made of gold, tantalum, platinum, PtW alloy or PtIr alloy. The coating developing identification part 32 is located at the connection between the coating 2 and the support body 1, that is, the coating developing identification part 32 is located at the boundary position of the coating 2. The coating identification part is formed by winding the developing wire around the support body 1, or by wrapping one end or several sections of the support body 1 with the developing wire, or by welding the developing ring on the support body 1, and is used to mark the precise position of the coating 2.
需要指出的是，由于各类血管病变的差异很大，在不超出本发明的核心理念的前提下，针对所述覆膜支架的所述支架主体1和所述覆膜2的尺寸、大小、形状以及适应症等相关的变形仍属于本发明的保护范畴。It should be pointed out that due to the great differences in various types of vascular lesions, without exceeding the core concept of the present invention, deformations related to the size, dimensions, shape and indications of the stent body 1 and the coating 2 of the coated stent still fall within the protection scope of the present invention.
可选地，所述支架主体1为自膨式网状结构，在所述支架主体1的骨架设计上，尽量减少支架覆盖率的同时保证支架的径向张力及良好的贴壁性能。所述覆膜2覆盖在所述支架主体1的所述中间段12靠近所述流入段11的部分，不完全覆盖所述中间段12。所述覆膜2的所述内层覆膜贴于所述支架主体1的内面，所述内层覆膜的内表面光滑并涂亲水涂层，与血液接触具有良好的血液相容性，可有效减少血栓形成，能够形成通畅的血流通道。所述覆膜2的所述外层覆膜贴于所述支架主体1的外面，所述外层覆膜的外表面为易促进内皮化的生物性膜材，可以诱发动脉瘤内或出血部分的血栓形成，促使动脉瘤快速激化缩小，减小体内占位效应；同时有效黏附内皮细胞和细胞分化，增殖加速血管病变部分内皮化，能更有效地治疗动脉瘤等血管疾病。所述支架主体未覆盖所述覆膜2的裸支架区域由于支架的覆盖率低，不易覆盖动脉瘤临近区域的分支血管，保留分支血管的供血功能。Optionally, the stent body 1 is a self-expanding mesh structure. In the skeleton design of the stent body 1, the stent coverage is minimized while ensuring the radial tension of the stent and good wall adhesion performance. The coating 2 covers the part of the middle section 12 of the stent body 1 close to the inflow section 11, and does not completely cover the middle section 12. The inner coating of the coating 2 is attached to the inner surface of the stent body 1. The inner surface of the inner coating is smooth and coated with a hydrophilic coating. It has good blood compatibility when in contact with blood, can effectively reduce thrombosis, and can form an unobstructed blood flow channel. The outer coating of the coating 2 is attached to the outside of the stent body 1. The outer surface of the outer coating is a biological membrane material that is easy to promote endothelialization, which can induce thrombosis in the aneurysm or bleeding part, promote the rapid intensification and shrinkage of the aneurysm, and reduce the space-occupying effect in the body; at the same time, it effectively adheres to endothelial cells and cell differentiation, and accelerates the endothelialization of the vascular lesion part, which can more effectively treat vascular diseases such as aneurysms. The bare stent area where the stent body is not covered by the coating 2 is not easy to cover the branch blood vessels in the vicinity of the aneurysm due to the low coverage rate of the stent, thereby retaining the blood supply function of the branch blood vessels.
本发明与微导管、微导丝、推送杆等可相互兼容，配合使用，均为本领域技术人员公知的现有技术。在植入前，首先进行造影，明确动脉瘤的位置、大小、瘤颈范围及分支血管的分布状况，选择合适规格的支架，微导管装载支架到位，观察显影点位置合适后缓慢释放支架，同时注意微调支架位置部分覆盖动脉瘤，并保留分支血管，解脱后再造影观察隔绝效果及分支血管通畅情况，退出手术器械。The present invention is compatible with microcatheters, microguidewires, push rods, etc., and can be used in conjunction with each other, which are all prior arts known to those skilled in the art. Before implantation, angiography is first performed to clarify the location, size, neck range, and distribution of branch vessels of the aneurysm, and a stent of appropriate specifications is selected. The stent is loaded into the microcatheter in place, and the stent is slowly released after the location of the developing point is observed to be appropriate. At the same time, attention is paid to fine-tuning the position of the stent to partially cover the aneurysm and retain the branch vessels. After release, angiography is performed again to observe the isolation effect and the patency of the branch vessels, and the surgical instrument is withdrawn.
以上进行了本发明的实施例讲述，本发明并不局限于上述特定的实施方式，尚可用于临近分支血管动静脉瘘的瘘口隔绝，故本领域技术人员可以在权利要求的范围内进行变形或增加应用范围。The above is a description of the embodiments of the present invention. The present invention is not limited to the above specific implementations, and can also be used to isolate the fistula of an arteriovenous fistula adjacent to a branch vessel. Therefore, those skilled in the art can make modifications or increase the scope of application within the scope of the claims.
还需要指出的是，在本发明中，通过在所述支架主体1的所述中间段12靠近所述流入段11的一端设置所述覆膜2，并且所述覆膜2对应覆盖动脉瘤开口的近心端，从而能够减小所述支架主体1所受到的压强大小，提高植入物整体的耐疲劳性，避免所述支架主体1破损和动脉瘤破裂。并且，植入所述覆膜2的部分能够采用金属覆盖率较低的支架主体1，以提高植入物的顺应性；通过在所述支架主体1的所述中间段12的局部覆膜，能够降低所述覆膜2对其他支动脉血管的干涉，增加适用范围。通常来说，覆膜支架植入后，血液进入动脉瘤的方式由动脉瘤开口的远心端改为近心端，本发明在动脉瘤开口的近心端覆膜，可进一步减少血流从所述动脉瘤开口的近心端的流入，加快动脉瘤的闭塞。研究表明，宽瘤颈和大口径流入是密网支架治疗未破裂侧壁颅内动脉瘤延迟闭塞的潜在原因，对于晚期闭塞的动脉瘤，在所述支架主体1对应动脉瘤开口的近心端进行覆膜，就是把宽瘤颈和大口径减为窄瘤颈和小口径，可减少近端瘤颈的血液流入量，加快动脉瘤的闭塞，同时，还会降低由于血流在瘤颈近端持续进入而引起动脉瘤破裂的风险。It should also be pointed out that in the present invention, by providing the coating 2 at one end of the middle section 12 of the stent body 1 close to the inflow section 11, and the coating 2 covers the proximal end of the aneurysm opening, the pressure on the stent body 1 can be reduced, the fatigue resistance of the implant as a whole can be improved, and the stent body 1 can be prevented from being damaged and the aneurysm ruptured. In addition, the part where the coating 2 is implanted can adopt a stent body 1 with a lower metal coverage rate to improve the compliance of the implant; by coating the middle section 12 of the stent body 1 locally, the interference of the coating 2 with other branch arteries can be reduced, thereby increasing the scope of application. Generally speaking, after the coated stent is implanted, the way blood enters the aneurysm is changed from the distal end of the aneurysm opening to the proximal end. The present invention coats the proximal end of the aneurysm opening, which can further reduce the inflow of blood from the proximal end of the aneurysm opening and accelerate the occlusion of the aneurysm. Studies have shown that wide neck and large-caliber inflow are potential reasons for delayed occlusion of unruptured sidewall intracranial aneurysms treated with dense mesh stents. For aneurysms with late occlusion, coating is performed on the proximal end of the stent body 1 corresponding to the aneurysm opening, which reduces the wide neck and large diameter to a narrow neck and small diameter, thereby reducing the blood inflow into the proximal neck and accelerating the occlusion of the aneurysm. At the same time, it also reduces the risk of aneurysm rupture caused by continuous blood flow entering the proximal neck.
根据本发明的另一方面，本发明进一步提供一种覆膜方法，包括：According to another aspect of the present invention, the present invention further provides a coating method, comprising:
在覆膜支架处于收缩状态时，控制覆膜支架进入具有动脉瘤的血管，并使得支架主体1的中间段12靠近流入段11的一端对应动脉瘤开口的近心端；When the stent graft is in a contracted state, the stent graft is controlled to enter the blood vessel with the aneurysm, and one end of the middle section 12 of the stent body 1 close to the inflow section 11 corresponds to the proximal end of the aneurysm opening;
允许所述覆膜支架切换至扩张状态，借由所述支架主体1撑开位于所述支架主体1的所述中间段12靠近所述流入段11的覆膜2，使得所述覆膜2覆盖所述动脉瘤开口的近心端。The coated stent is allowed to switch to an expanded state, and the coating 2 located in the middle section 12 of the stent body 1 close to the inflow section 11 is stretched open by the stent body 1, so that the coating 2 covers the proximal end of the aneurysm opening.
需要指出的是，在本发明所提供的所述覆膜方法中，将所述覆膜支架的所述覆膜2覆盖动脉瘤开口的近心端，以进一步阻止或减小血管中的血流进入动脉瘤，以有利于动脉瘤的修复。It should be pointed out that in the coating method provided by the present invention, the coating 2 of the coated stent covers the proximal end of the aneurysm opening to further prevent or reduce the blood flow in the blood vessel from entering the aneurysm, so as to facilitate the repair of the aneurysm.
进一步地，所述覆膜支架的所述覆膜2的长度大于所述动脉瘤长度的一半，并且小于所述动脉瘤的长度，以在对动脉瘤开口的近心端进行遮覆时，避免遮覆分支血管。Furthermore, the length of the coating 2 of the stent graft is greater than half the length of the aneurysm and less than the length of the aneurysm, so as to avoid covering the branch blood vessels when covering the proximal end of the aneurysm opening.
应当说明的是，上述实施例均可根据需要自由组合。以上仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本发明原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。It should be noted that the above embodiments can be freely combined as needed. The above are only preferred embodiments of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be regarded as the protection scope of the present invention.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010742203.3ACN114052981B (en) | 2020-07-29 | 2020-07-29 | A coated stent and a coating method |
| PCT/CN2021/100497WO2022022142A1 (en) | 2020-07-29 | 2021-06-17 | Covered stent and covering method |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010742203.3ACN114052981B (en) | 2020-07-29 | 2020-07-29 | A coated stent and a coating method |
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| CN114052981A CN114052981A (en) | 2022-02-18 |
| CN114052981Btrue CN114052981B (en) | 2024-08-16 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202010742203.3AActiveCN114052981B (en) | 2020-07-29 | 2020-07-29 | A coated stent and a coating method |
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| WO (1) | WO2022022142A1 (en) |
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