技术领域technical field
本发明涉及一种附海绵结构的防内漏支架，属于医疗器械领域。The invention relates to an anti-endoleak bracket with a sponge structure, which belongs to the field of medical instruments.
背景技术Background technique
动脉瘤是最常见的引发致残和致死的血管疾病之一，可见于全身的任何动脉，以老年人多见。动脉瘤可以有多种大小、形态和分布，血管外科协会审计报告特别委员会(the Ad Hoc Committee onReporting Standards of the Society for Vascular Surgery)定义动脉瘤为：动脉血管直径超过正常动脉管径50％的永久性局限性扩张，以便于临床决策而进行分类和标准化。Aneurysms, one of the most common disabling and fatal vascular diseases, can occur in any artery throughout the body, and are more common in the elderly. Aneurysms can have a variety of sizes, shapes, and distributions. The Ad Hoc Committee on Reporting Standards of the Society for Vascular Surgery defines an aneurysm as a permanent artery with a diameter greater than 50% of the normal arterial diameter. Classification and standardization for clinical decision-making.
最早有关于试图治疗动脉瘤的记载源于公元3世纪，直至1888年，Matas等人完成了第一例真正意义上的动脉瘤修补术，即在肱动脉瘤的瘤腔内结扎分支动脉。1951年，Dubost等完成了第一例动脉瘤缝合修补术，他们切除一位患者的腹主动脉瘤，并选择了一位20岁遗体捐献者的胸主动脉作为同种移植物，移植到腹主动脉瘤患者体内，该患者术后存活了8年。修补动脉瘤的开放手术在随后的40年里逐渐得到完善及优化，但其围手术期死亡率仍高达5％。1991年，Parodi等人首次报道应用人工血管内支架复合物修复主动脉瘤的经验。食品药品管理局(FDA)批准血管内移植物的临床应用后，动脉瘤(包括外周动脉瘤和主动脉瘤)经历了由开放旁路修复术向血管腔内修复术的演变。The earliest record of attempting to treat aneurysms dates back to the 3rd century AD. Until 1888, Matas et al. completed the first real aneurysm repair, that is, ligated branch arteries in the aneurysm cavity of the brachial aneurysm. In 1951, Dubost et al. completed the first case of aneurysm suturing repair. They resected the abdominal aortic aneurysm of a patient, and selected the thoracic aorta of a 20-year-old deceased donor as an allograft and transplanted it into the abdominal aorta. In a patient with an aortic aneurysm, the patient survived for 8 years after surgery. The open surgery for aneurysm repair has gradually been perfected and optimized in the following 40 years, but its perioperative mortality rate is still as high as 5%. In 1991, Parodi et al first reported the experience of repairing aortic aneurysm with artificial stent composite. After the Food and Drug Administration (FDA) approved the clinical application of endovascular grafts, aneurysms (including peripheral aneurysms and aortic aneurysms) underwent an evolution from open bypass repair to endovascular repair.
与传统开放手术相比，使用覆膜支架进行腔内隔绝术治疗动脉瘤、动脉夹层等疾病具有手术创伤小、术后恢复快、住院时间短等优点，但其特有的并发症——内漏，到目前还无法完全避免。内漏是腔内隔绝术后最重要的并发症之一，其发生率高达45％。内漏按其发生机制可分为I-V型。其中，II型内漏的发生与支架移植物没有相关性，不做赘述。以下就除II型内漏以外的内漏类型进行简要介绍，I型内漏是指由于支架覆膜与锚定区动脉内壁贴服不良，致使血流经覆膜支架近心端或远心端渗漏至动脉瘤腔内，其发生率约10％，往往可在术中造影发现。因I型内漏的存在可导致动脉瘤腔内高压、动脉瘤持续扩大甚至有发生破裂的风险，所以需要术中立即处理。一般认为，近端锚定区[解释此概念]＜10mm，和/或瘤颈成角【解释此概念】＞60°，I型内漏发生率将明显升高，其中锚定区是指瘤腔的近远端有一段足够长度的正常血管壁以保证血管支架与其有充分的贴敷，这样一段长度的血管壁定义为锚定区(landing zone，LZ)，包括近端和远端LZ；瘤颈成角是指瘤颈中轴线与主动脉主干中轴线之间所成的夹角。目前，对于术中发现的I型内漏一般处理方式为：球囊扩张、加用短段的支架移植物、裸支架或利用氰基丙烯酸酯、Onyx胶、弹簧圈、纤维蛋白胶的栓塞技术。这些技术虽然能处理大多数I型内漏，但在某些情况下将会非常困难，如：腹主动脉瘤近端锚定区过短，在近端加用短段移植物有可能影响肾动脉血供。Maldonado等总结目前上述方法处理I型内漏的效果：氰基丙烯酸酯栓塞剂成功率为92.3％，近端短段移植物为80％，弹簧圈为75％。III型内漏是指覆膜支架壁上存在缺陷，血管腔内血液经覆膜支架壁的缺陷处渗漏至动脉瘤腔内所形成的内漏。IV型内漏是III型内漏的另一种形式，其特点是植入覆膜支架一个月内血管腔内血流自覆膜支架的弥漫性渗漏。V型内漏又称“内张力”内漏，是指在腔内隔绝术后，经血管造影或CT动脉成像没有发现明显内漏存在，但是动脉瘤内压力增加，瘤腔扩大的情况。Compared with traditional open surgery, the use of covered stents for endovascular exclusion in the treatment of aneurysms, arterial dissection and other diseases has the advantages of less surgical trauma, faster postoperative recovery, and shorter hospital stay, but its unique complication—endoleak , so far cannot be completely avoided. Endoleak is one of the most important complications after endovascular exclusion, and its incidence rate is as high as 45%. Endoleaks can be divided into types I-V according to their mechanism of occurrence. Among them, the occurrence of type II endoleak is not related to the stent graft, so it will not be repeated here. The following is a brief introduction to the types of endoleaks other than type II endoleaks. Type I endoleaks refer to poor adherence between the stent graft and the inner wall of the artery in the anchoring area, causing blood to flow through the proximal or distal end of the stent graft. Leakage into the aneurysm cavity, the incidence rate is about 10%, and can often be found in intraoperative angiography. Because the existence of type I endoleak can lead to high pressure in the aneurysm cavity, continuous expansion of the aneurysm, and even the risk of rupture, it needs to be treated immediately during the operation. It is generally believed that the incidence of type I endoleak will increase significantly when the proximal anchoring zone [explain this concept] < 10mm, and/or the aneurysm neck angle [explain this concept] > 60°, where the anchoring zone refers to the aneurysm There is a sufficient length of normal vessel wall at the proximal and distal ends of the lumen to ensure that the vascular stent is fully attached to it. Such a length of vessel wall is defined as the landing zone (LZ), including the proximal and distal LZs; Neck angulation refers to the angle formed between the central axis of the aneurysmal neck and the central axis of the aortic trunk. At present, the general treatment methods for type I endoleaks found during surgery are: balloon expansion, addition of short-stent grafts, bare stents, or embolization techniques using cyanoacrylate, Onyx glue, coils, and fibrin glue . Although these techniques can deal with most type I endoleaks, they will be very difficult in some cases, such as: the proximal anchoring zone of abdominal aortic aneurysm is too short, and the addition of a short graft at the proximal end may affect the kidney Arterial blood supply. Maldonado et al. summarized the current effects of the above methods in dealing with type I endoleaks: the success rate of cyanoacrylate embolic agents was 92.3%, that of proximal short-segment grafts was 80%, and that of coils was 75%. Type III endoleak refers to the defect in the wall of the stent graft, and the blood in the vessel lumen leaks into the aneurysm cavity through the defect of the stent graft wall. Type IV endoleak is another form of type III endoleak, which is characterized by diffuse leakage of blood flow in the vessel lumen from the stent-graft within one month after implantation of the stent-graft. V-type endoleak, also known as "internal tension" endoleak, refers to the situation that after endovascular isolation, no obvious endoleak is found by angiography or CT angiography, but the pressure in the aneurysm increases and the aneurysm cavity expands.
上述内漏发生时，无论采取哪种处理方式，不仅存在成功率的问题，还存在着大量增加手术时间和医疗费用的问题，并且手术时间延长使得患者术中风险、术后感染发生率增高，高昂的医疗费用给患者带来高额的经济负担，同时占用更多的社会资源。When the above-mentioned endoleak occurs, no matter which treatment method is adopted, there is not only the problem of success rate, but also the problem of a large increase in operation time and medical expenses, and the prolongation of operation time increases the risk of patients during operation and the incidence of postoperative infection. High medical expenses bring a high economic burden to patients and occupy more social resources.
发明内容Contents of the invention
为解决上述问题，本发明重新设计了腔内隔绝术中使用的支架，以避免除II型内漏以外的其它类型内漏的发生。In order to solve the above problems, the present invention redesigns the stent used in the endoluminal isolation operation to avoid the occurrence of other types of endoleaks except Type II endoleaks.
本发明采用了如下技术方案：The present invention adopts following technical scheme:
<结构一><Structure 1>
一种附海绵结构的防内漏支架，用于预防除II型内漏以外的内漏，其特征在于，包括：An anti-endoleak bracket with a sponge structure for preventing endoleaks other than type II endoleaks, characterized in that it includes:
与动脉血管形状相匹配的金属网状支撑层；Metal mesh support layer matching the shape of arteries;
覆盖于金属网状支撑层上的覆膜层；以及a coating layer covering the metal mesh support layer; and
分布于覆膜层外侧的海绵层，海绵层在自身弹性的作用下填充于动脉血管的内壁与覆膜层之间所形成的缝隙中。The spongy layer distributed on the outside of the covering layer, under the action of its own elasticity, the sponge layer fills in the gap formed between the inner wall of the arterial vessel and the covering layer.
另外，本发明的附海绵结构的防内漏支架，还可以具有这样的特征：In addition, the anti-endoleak bracket with sponge structure of the present invention can also have the following features:
其中，海绵层的厚度范围是1mm-5mm。Wherein, the thickness range of the sponge layer is 1mm-5mm.
另外，本发明的附海绵结构的防内漏支架，还可以具有这样的特征：In addition, the anti-endoleak bracket with sponge structure of the present invention can also have the following features:
其中，海绵层的材料是聚乙丙交酯PGLA。Wherein, the material of the sponge layer is polyglycolide PGLA.
另外，本发明的附海绵结构的防内漏支架，还可以具有这样的特征：In addition, the anti-endoleak bracket with sponge structure of the present invention can also have the following features:
其中，海绵层不超出金属网状支撑层和覆膜层的端部的边缘。Wherein, the sponge layer does not exceed the edges of the ends of the metal mesh support layer and the coating layer.
另外，本发明的附海绵结构的防内漏支架，还可以具有这样的特征：In addition, the anti-endoleak bracket with sponge structure of the present invention can also have the following features:
其中，海绵层由能够吸附血液中的凝血因子和血小板等血细胞的材料制成。Wherein, the sponge layer is made of materials capable of absorbing blood cells such as coagulation factors and platelets in the blood.
另外，本发明的附海绵结构的防内漏支架，还可以具有这样的特征：In addition, the anti-endoleak bracket with sponge structure of the present invention can also have the following features:
其中，海绵层上具有均匀分布的菱形凹陷，并且菱形的较长的一条对角线与血流方向一致。Wherein, there are evenly distributed diamond-shaped depressions on the sponge layer, and the longer diagonal line of the rhombus is consistent with the direction of blood flow.
<结构二><Structure 2>
一种附海绵结构的防内漏支架，用于预防除II型内漏以外的内漏，其特征在于，包括：An anti-endoleak bracket with a sponge structure for preventing endoleaks other than type II endoleaks, characterized in that it includes:
与动脉血管形状相匹配的金属网状支撑层；Metal mesh support layer matching the shape of arteries;
覆盖于金属网状支撑层上的覆膜层；以及a coating layer covering the metal mesh support layer; and
分布于覆膜层外侧的弹性网格层，弹性网格层在自身弹性的作用下填充于动脉血管的内壁与覆膜之间所形成的缝隙中。The elastic mesh layer distributed on the outer side of the covering layer, the elastic mesh layer fills the gap formed between the inner wall of the arterial vessel and the covering film under the action of its own elasticity.
另外，本发明的附海绵结构的防内漏支架，还可以具有这样的特征：In addition, the anti-endoleak bracket with sponge structure of the present invention can also have the following features:
其中，弹性网格层由多个多面体的棱组合而成。Wherein, the elastic grid layer is composed of edges of multiple polyhedrons.
另外，本发明的附海绵结构的防内漏支架，还可以具有这样的特征：In addition, the anti-endoleak bracket with sponge structure of the present invention can also have the following features:
其中，多面体为双三角锥柱。Among them, the polyhedron is a double triangular pyramid.
发明作用与效果Invention function and effect
根据本发明的附海绵结构的防内漏支架，由于在覆膜层外侧还采用了海绵层，并且海绵层在自身弹性的作用下填充于内壁与覆膜层之间所形成的缝隙中，使得血流不能直接冲入瘤腔，在海绵内的血液在经过一段时间后会发生血液凝固，从而将瘤腔完全封闭，使得瘤腔进入稳定的状态。由于本发明在覆膜层外面还设置了海绵层，弹性网格实际上也可以看作是一种微观结构规则的海绵。因此除了能够很好的预防I型内漏的发生之外，还能够预防III、IV及V型内漏的发生。According to the anti-endoleak bracket with sponge structure of the present invention, since a sponge layer is also used outside the film layer, and the sponge layer is filled in the gap formed between the inner wall and the film layer under the action of its own elasticity, so that The blood flow cannot directly rush into the tumor cavity, and the blood in the sponge will coagulate after a period of time, thereby completely sealing the tumor cavity and making the tumor cavity enter a stable state. Since the present invention also arranges a sponge layer outside the coating layer, the elastic grid can actually be regarded as a sponge with regular microstructure. Therefore, in addition to being able to well prevent the occurrence of type I endoleaks, it can also prevent the occurrence of type III, IV and V endoleaks.
附图说明Description of drawings
图1是本发明的附海绵结构的防内漏支架的整体结构示意图；Fig. 1 is the overall structure schematic diagram of the anti-endoleak bracket with sponge structure of the present invention;
图2是本发明的附海绵结构的防内漏支架的内部结构示意图；Fig. 2 is a schematic view of the internal structure of the anti-endoleak bracket with sponge structure of the present invention;
图3是本发明的附海绵结构的防内漏支架的横截面图；Fig. 3 is the cross-sectional view of the anti-endoleak bracket with sponge structure of the present invention;
图4是本发明的附海绵结构的防内漏支架植入血管处的示意图；Fig. 4 is a schematic diagram of the place where the anti-endoleak stent with sponge structure of the present invention is implanted into a blood vessel;
图5是图4中BB’处的剖面示意图；Fig. 5 is a schematic cross-sectional view at BB' in Fig. 4;
图6是本发明的附海绵结构的防内漏支架的海绵表面具有菱形网格的示意图；Fig. 6 is a schematic diagram of a diamond-shaped grid on the sponge surface of the anti-endoleak bracket with a sponge structure of the present invention;
图7是本发明的附海绵结构的防内漏支架的表面覆盖有弹性网格层的示意图；Fig. 7 is a schematic diagram of the surface of the anti-endoleak bracket with sponge structure covered with an elastic mesh layer of the present invention;
图8是本发明的附海绵结构的防内漏支架的网格结构的基本组成单元示意图；Fig. 8 is a schematic diagram of the basic unit of the grid structure of the anti-endoleak bracket with sponge structure of the present invention;
图9是本发明的附海绵结构的防内漏支架的网格结构的弹性网格层在支架的长轴方向上的部分截面图；Fig. 9 is a partial cross-sectional view of the elastic grid layer of the grid structure of the anti-endoleak stent with sponge structure of the present invention in the direction of the long axis of the stent;
图10是弹性网格的单体的交错排列方式的示意图。Fig. 10 is a schematic diagram of the staggered arrangement of the monomers of the elastic grid.
具体实施方式Detailed ways
由于造成I型内漏，即由于支架覆膜与锚定区动脉内壁贴服不良，致使血流经覆膜支架近心端或远心端渗漏至动脉瘤腔内的原因很多，本发明的附海绵结构的防内漏支架对于各种原因所引起的I型内漏均具有预防的作用。具体实施方式中仅以由动脉硬化斑块引起的支架覆膜与锚定区动脉内壁贴服不良为例来进行说明。Due to the formation of Type I endoleak, that is, due to poor adhesion between the stent covering and the inner wall of the artery in the anchoring area, there are many reasons for the blood to leak into the aneurysm cavity through the proximal end or the distal end of the covering stent. The anti-endoleak bracket with sponge structure can prevent type I endoleak caused by various reasons. In the specific embodiment, the description will be made only by taking the poor adherence between the stent covering and the inner wall of the artery in the anchoring area caused by the arteriosclerotic plaque as an example.
以下结合附图来说明本发明的具体实施方式。The specific implementation manners of the present invention will be described below in conjunction with the accompanying drawings.
<实施例一><Example 1>
图1是本发明的附海绵结构的防内漏支架的整体结构示意图，图2是本发明的附海绵结构的防内漏支架的内部结构示意图。如图1和图2所示，附海绵结构的防内漏支架10具有金属网状支撑层11、覆膜层12以及海绵层13。金属网状支撑层11位于最内层，覆膜层12覆盖于其外层，海绵层13位于覆膜层12的外层。Figure 1 is a schematic diagram of the overall structure of the anti-endoleak bracket with a sponge structure of the present invention, and Figure 2 is a schematic diagram of the internal structure of the anti-endoleak bracket with a sponge structure of the present invention. As shown in FIG. 1 and FIG. 2 , the anti-endoleak stent with sponge structure 10 has a metal mesh support layer 11 , a coating layer 12 and a sponge layer 13 . The metal mesh support layer 11 is located in the innermost layer, the coating layer 12 covers the outer layer, and the sponge layer 13 is located in the outer layer of the coating layer 12 .
覆膜层12常用的材料是涤纶，又称对苯二甲酸乙二酯。海绵层使用的材料是聚乙丙交酯，化学名称缩写PGLA。聚乙丙交酯材料具有吸附凝血因子和血小板等血细胞的作用。海绵层13与覆膜层通过粘贴等方式固定连接。海绵层整体覆盖于支架的外面，但是两端不超出金属网状支撑层的两端，最好相对于金属网状支撑层的两端再向内回缩一点。The commonly used material for the coating layer 12 is polyester, also known as ethylene terephthalate. The material used in the sponge layer is polyglycolide, the chemical name is abbreviated as PGLA. The polylactide material has the function of adsorbing blood cells such as coagulation factors and platelets. The sponge layer 13 is fixedly connected with the coating layer by sticking or the like. The sponge layer covers the outside of the stent as a whole, but the two ends do not exceed the two ends of the metal mesh support layer, and it is better to retract a little inward relative to the two ends of the metal mesh support layer.
图3是本发明的附海绵结构的防内漏支架的横截面图，图4是本发明的附海绵结构的防内漏支架植入血管处的示意图，图5是图4中BB’处的剖面示意图。如图3、图4和图5所示，当将附海绵结构的防内漏支架10植入动脉瘤发生处的血管中时，瘤腔16附近的动脉血管14的血管壁上存在有动脉硬化斑块15，动脉硬化斑块15向血管壁内突出，将附海绵结构的防内漏支架10的金属网状支撑层11和覆膜层12顶起，在覆膜层12和血管内壁之间形成缝隙，由于海绵层13具有弹性，因此会填充在缝隙之中，并且由于海绵具有多孔结构。血液在被海绵填充的缝隙中的流速大大下降，同时由于血液中的凝血因子的作用，在经过一段时间后海绵填充的缝隙中残留的血液会发生凝固，从而将缝隙封闭。Fig. 3 is a cross-sectional view of the anti-endoleak stent with sponge structure of the present invention, Fig. 4 is a schematic diagram of the place where the anti-endoleak stent with sponge structure of the present invention is implanted into a blood vessel, and Fig. 5 is a view at BB' in Fig. 4 Sectional schematic. As shown in Fig. 3, Fig. 4 and Fig. 5, when the anti-endoleak stent 10 with the spongy structure is implanted in the blood vessel where the aneurysm occurs, there is arteriosclerosis on the blood vessel wall of the arterial vessel 14 near the aneurysm cavity 16. Plaque 15, arteriosclerotic plaque 15 protrudes into the blood vessel wall, and pushes up the metal mesh support layer 11 and coating layer 12 of the anti-endoleak stent 10 with a sponge structure, between the coating layer 12 and the inner wall of the blood vessel Gap is formed, because the sponge layer 13 has elasticity, it can be filled in the gap, and because the sponge has a porous structure. The flow rate of blood in the gap filled by the sponge is greatly reduced, and at the same time due to the effect of coagulation factors in the blood, the blood remaining in the gap filled by the sponge will coagulate after a period of time, thereby sealing the gap.
在缝隙存在的情况下还有一个不良影响，就是由于缝隙处一直处于血流的冲击之下，血管内壁中的内皮细胞无法长入支架的内部，使得支架的边缘不能被内皮细胞覆盖进而与血管内皮连成一片。在植入本实施例的附海绵结构的防内漏支架10之后，由于缝隙处的血流速度下降，使得支架缝隙附近血管壁上的上皮细胞有充分的时间逐渐长入附海绵结构的防内漏支架10的内表面，最终将支架内表面完全覆盖，与两端的血管内皮连成一片。从而使得支架进入稳定的状态，瘤腔内不会再充入血液，瘤腔内存留的血液凝固后瘤腔会进入稳定状态，进而内皮细胞增生，长入瘤腔中，使得瘤腔不易发生破裂。In the case of gaps, there is another adverse effect, that is, because the gaps are always under the impact of blood flow, the endothelial cells in the inner wall of the blood vessels cannot grow into the inside of the stent, so that the edges of the stent cannot be covered by endothelial cells and thus communicate with the blood vessels. The inner skin is connected into one piece. After implanting the anti-endoleak stent 10 with the spongy structure of this embodiment, the epithelial cells on the blood vessel wall near the stent gap have sufficient time to gradually grow into the anti-endoleak stent with the spongy structure due to the decrease in the blood flow velocity at the gap. The inner surface of the leaky stent 10 finally completely covers the inner surface of the stent and connects with the vascular endothelium at both ends. As a result, the stent enters a stable state, the tumor cavity will not be filled with blood, and the tumor cavity will enter a stable state after the blood remaining in the tumor cavity coagulates, and then endothelial cells proliferate and grow into the tumor cavity, making the tumor cavity less likely to rupture .
如图1所示，A方向指动脉血流方向，靠近A方向的一端为近心端，远离A方向的一端为远心端。海绵层13的长度不超出金属网状支撑层和覆膜层的上下两端的边缘，这是为了防止海绵从附海绵结构的防内漏支架10的边缘伸出，造成此处的血流凝固，形成血栓，在血流的冲击下进入血管之中栓塞血管。As shown in Figure 1, direction A refers to the direction of arterial blood flow, the end close to direction A is the proximal end, and the end farther from direction A is the distal end. The length of the sponge layer 13 does not exceed the edges of the upper and lower ends of the metal mesh support layer and the coating layer, this is to prevent the sponge from stretching out from the edge of the anti-endoleak support 10 with the sponge structure, causing the blood flow here to coagulate, A thrombus forms and enters the blood vessel under the impact of the blood flow to embolize the blood vessel.
PGLA材料生物降解的时间有多种影响因素，因此可以有多种调节的方法，这里仅提供一种方法：通过在聚合时调节乙交酯和丙交酯这两种单体的比例来调节，随着乙交酯在共聚物中的摩尔比增加，PGLA的降解速度增加，当乙交酯：丙交酯＝50：50时，降解时间为50-60天，当乙交酯：丙交酯＝85：15时，降解时间为150天。内漏处凝血到成纤维细胞长入再到纤维化的完成的时间一般在两周内即可完成，为保证有充足的时间使得动脉瘤腔和I型内漏进入稳定状态，降解时间在50-150天之间为宜，这样不会由于PGLA降解时间过短而影响I型内漏的封闭。There are many factors affecting the biodegradation time of PGLA materials, so there are many adjustment methods, here is only one method: by adjusting the ratio of the two monomers glycolide and lactide during polymerization, As the molar ratio of glycolide in the copolymer increases, the degradation rate of PGLA increases. When glycolide: lactide = 50:50, the degradation time is 50-60 days. When glycolide: lactide =85:15, the degradation time is 150 days. The time from coagulation at the endoleak to the growth of fibroblasts and then to the completion of fibrosis is generally completed within two weeks. To ensure sufficient time for the aneurysm cavity and type I endoleak to enter a stable state, the degradation time is 50 It is advisable between -150 days, so that the closure of type I endoleak will not be affected due to the too short degradation time of PGLA.
实施例一的作用与效果Function and effect of embodiment one
根据实施例一中的附海绵结构的防内漏支架，根据本发明的附海绵结构的防内漏支架，由于在覆膜层外侧还采用了海绵层，并且海绵层在自身弹性的作用下填充于内壁与覆膜层之间所形成的缝隙中，当血管壁上具有动脉硬化块时，具有弹性的海绵层会将被动脉硬化块支起的金属网状支撑层和覆膜层与血管内壁之间所形成的缝隙填充，使得血流不能直接冲入瘤腔，在海绵内的血液在经过一段时间后会凝固，从而将瘤腔完全封闭，使得瘤腔进入稳定的状态。海绵形成的网格有三方面的作用，一方面是物理阻隔，使得血液在此处的流速大大减缓，从而促进凝血，另一方面是化学作用，PGLA能够吸附凝血因子和血小板等血细胞，进一步促进凝血；同时，网格结构还充当了纤维化形成的基质。According to the anti-endoleak bracket with a sponge structure in Embodiment 1, according to the anti-endoleak bracket with a sponge structure of the present invention, since a sponge layer is also used outside the coating layer, and the sponge layer is filled under the action of its own elasticity In the gap formed between the inner wall and the covering layer, when there is an arteriosclerotic block on the blood vessel wall, the elastic sponge layer will connect the metal mesh support layer and covering layer supported by the arteriosclerotic block with the inner wall of the blood vessel. The gap formed between the sponges is filled so that the blood flow cannot directly rush into the tumor cavity, and the blood in the sponge will coagulate after a period of time, thereby completely sealing the tumor cavity and making the tumor cavity enter a stable state. The mesh formed by the sponge has three functions. On the one hand, it is a physical barrier, which greatly slows down the flow of blood here, thereby promoting coagulation. On the other hand, it is a chemical effect. ; At the same time, the grid structure also acts as a matrix for the formation of fibrosis.
另外，由于海绵层的长度不超出金属网状支撑层和覆膜层的上下两端的边缘，因此能够防止海绵从附海绵结构的防内漏支架10的边缘伸出，造成此处的血流凝固，形成血栓，在血流的冲击下进入血管之中栓塞血管。In addition, because the length of the sponge layer does not exceed the edges of the upper and lower ends of the metal mesh support layer and the coating layer, it can prevent the sponge from protruding from the edge of the anti-endoleak stent 10 with a sponge structure, causing blood coagulation here , Form a thrombus, enter the blood vessel under the impact of blood flow and embolize the blood vessel.
附海绵结构的防内漏支架10的植入方法：The implantation method of the anti-endoleak stent 10 with sponge structure:
将附海绵结构的防内漏支架10安装在支架输送器上，通过输送器输送到血管病变处，通过释放装置使输送器逐渐均匀退出具有自膨特性的支架，进而附海绵结构的防内漏支架10封闭瘤腔内的血流，然后撤出输送系统，使得支架永久置于病变处，达到封闭血管瘤瘤腔的目的。Install the anti-endoleak stent 10 with a sponge structure on the stent conveyor, deliver it to the vascular lesion through the conveyor, and use the release device to make the conveyor gradually and evenly withdraw from the stent with self-expanding characteristics, and then attach the anti-endoleak stent with a sponge structure The stent 10 seals the blood flow in the tumor cavity, and then withdraws from the delivery system, so that the stent is permanently placed in the lesion, achieving the purpose of sealing the tumor cavity of the hemangioma.
手术过程中，利用DSA(数字剪影血管造影)监视输送器在人体内从小动脉进入主动脉，最后到达瘤腔的全过程。During the operation, DSA (Digital Silhouette Angiography) is used to monitor the whole process of the delivery device entering the aorta from the small artery in the human body and finally reaching the tumor cavity.
<实施例二><Example 2>
在本实施例二中，对与上述实施例相同的结构，本变形例给予相同的编号，并省去相同的说明。In this second embodiment, for the same structures as those of the above-mentioned embodiment, this modified example assigns the same numbers, and the same descriptions are omitted.
图6是本发明的附海绵结构的防内漏支架的海绵表面具有菱形网格的示意图；如图6所示，附海绵结构的防内漏支架20的海绵层具有均匀排列的菱形网格23，菱形网格23中具有菱形凹槽231。菱形网格23一方面能够节省海绵所用的材料，另一方面由于菱形凹槽231具有一定的空间，这些空间在植入后有可能刚好容纳下动脉硬化块，同时，由于海绵表面不是完全由平的海绵覆盖，动脉硬化块仅需要顶起与菱形凹槽23之间的突起楞边，因此动脉硬化块顶起海绵所用的力也很小，反过来说，相比实施例一中完全充实的海绵，支架对动脉硬化块和血管壁的压力较小，对血管的刺激也更小。Fig. 6 is the schematic diagram that the sponge surface of the anti-endoleak bracket with sponge structure of the present invention has a rhombus grid; as shown in Fig. , there are rhombus grooves 231 in the rhombus grid 23 . On the one hand, the rhombus grid 23 can save the material used in the sponge. On the other hand, because the rhombus groove 231 has a certain space, these spaces may just accommodate the arteriosclerosis after implantation. At the same time, because the surface of the sponge is not completely flat covered by the sponge, the arteriosclerotic block only needs to lift up the protruding edge between the diamond-shaped groove 23, so the force used by the arteriosclerotic block to push up the sponge is also very small. , The stent puts less pressure on the arteriosclerotic block and blood vessel wall, and less stimulates the blood vessel.
<实施例三><Example Three>
在本实施例三中，对与上述实施例相同的结构，本变形例给予相同的编号，并省去相同的说明。In the third embodiment, for the same structures as those in the above embodiment, the modification is assigned the same numbers and the same descriptions are omitted.
图7是本发明的附海绵结构的防内漏支架的表面覆盖有弹性网格层的示意图，如图7所示，弹性网格层31覆盖于附海绵结构的防内漏支架30的最外层。图8是本发明的附海绵结构的防内漏支架的网格结构的基本组成单元示意图，如图8所示，弹性网格层的基本组成单元131是由双三角锥柱的棱形成，内部和柱面均为空心。基本组成单元由PGLA材料制成。Fig. 7 is the schematic diagram that the surface of the anti-endoleak bracket with sponge structure of the present invention is covered with elastic mesh layer, as shown in Fig. 7, the elastic mesh layer 31 covers the outermost of the anti-endoleak bracket with sponge structure 30 layer. Fig. 8 is a schematic diagram of the basic unit of the grid structure of the anti-endoleak bracket with a sponge structure of the present invention. As shown in Fig. 8, the basic unit 131 of the elastic grid layer is formed by the ribs of the double triangular pyramid, and the inner and cylinder are hollow. The basic constituent unit is made of PGLA material.
图9是本发明的附海绵结构的防内漏支架的网格结构的示意图，如图9所示，多个基本组成单元131层叠在一起形成弹性网格片132。基本组成单元131的长轴与支架的中心轴垂直，首尾连接形成单层，如图10所示，图10是由垂直于图9的画面的截面得到的部分截面图，多个单层之间在两个基本组成单元131的连接处交错形成多层交错结构的弹性网格层31。弹性网格层31形成圆柱形包围在附海绵结构的防内漏支架外面。FIG. 9 is a schematic diagram of the grid structure of the anti-endoleak bracket with sponge structure of the present invention. As shown in FIG. 9 , a plurality of basic constituent units 131 are stacked together to form an elastic grid sheet 132 . The long axis of the basic component unit 131 is perpendicular to the central axis of the support, and the end to end connection forms a single layer, as shown in Figure 10, Figure 10 is a partial cross-sectional view obtained from a section perpendicular to the picture in Figure 9, between multiple single layers The elastic grid layer 31 of multi-layer interlaced structure is formed by interlacing at the junction of two basic constituent units 131 . The elastic grid layer 31 forms a cylinder and surrounds the outside of the anti-endoleak stent with a sponge structure.
由于弹性网格层的基本组成单元的形状为双三角锥柱的形状，并且双三角锥柱的长轴方向与支架的长轴方向相垂直，因此双三角锥柱在受到血管壁施加的垂直于支架的长轴方向的力之后更容易产生形变，从而使得海绵层对封闭支架与动脉壁之间的I型内漏的填充具有更加严密的效果。当然，弹性网格层也可以由其它形状的多个多面体的棱组合而成。例如六面体或者四面体。优选的是使用本发明实施例中所采用的双三角锥柱，即九面体中的一种。Since the basic unit of the elastic grid layer is in the shape of a double triangular pyramid, and the long axis direction of the double triangular pyramid is perpendicular to the long axis of the stent, the double triangular pyramid is perpendicular to the The force in the direction of the long axis of the stent is more likely to deform, so that the sponge layer has a tighter effect on filling the type I endoleak between the stent and the arterial wall. Of course, the elastic mesh layer can also be composed of edges of multiple polyhedrons of other shapes. For example hexahedron or tetrahedron. It is preferred to use the double triangular pyramid prism used in the embodiment of the present invention, that is, one of the nonahedrons.
当然，以上实施例中采用的双三角锥柱的长轴方向与整个支架的长轴方向相垂直是本发明优选的实施方式，双三角锥柱的长轴方向与整个支架的长轴方向也可以设置为其它的角度，只要不是平行即可，两者之间的角度越接近垂直的角度效果越好。Of course, it is a preferred embodiment of the present invention that the long axis direction of the double triangular pyramid column adopted in the above embodiment is perpendicular to the long axis direction of the whole support, and the long axis direction of the double triangular pyramid column and the long axis direction of the whole support can also be Set it to other angles, as long as it is not parallel, the closer the angle between the two is to the vertical angle, the better the effect.
在上述三个实施例中，由于海绵层整体覆盖于支架的外面，因此对于近心端和远心端的I型内漏均具有预防的作用。In the above three embodiments, since the sponge layer covers the outside of the stent as a whole, it can prevent type I endoleaks at both the proximal end and the distal end.
另外，由于本发明在覆膜层外面还设置了海绵层，弹性网格实际上也可以看作是一种微观结构规则的海绵。因此除了能够很好的预防I型内漏的发生之外，还能够预防III至IV型内漏的发生，由于III型内漏是指支架上的覆膜层发生破裂而引发的内漏，而传统支架上的覆膜层破裂后瘤腔就会直接与血管中的血流相通，没有任何阻隔，而本发明在加入了海绵层之后，即便覆膜层发生破裂，瘤腔和血管中的血液之间还间隔着一层海绵层，由于海绵层是多孔结构，血液在进入多孔结构中时流速会大大下降，因此可以有效的防止血液快速的冲入瘤腔，造成瘤腔的破裂，同时，存留在海绵层中的血液由于流速减慢，并且海绵结构可以吸附凝血因子和血小板，使得渗入海绵结构内的血液形成血凝块，因此在经过一段时间之后海绵层以及其内部凝固的血凝块发挥彻底封闭瘤腔的作用。同样道理，由于海绵层的存在使得IV、V型内漏也能够得到有效的预防。In addition, since the present invention also provides a sponge layer outside the coating layer, the elastic grid can actually be regarded as a sponge with regular microstructure. Therefore, in addition to being able to well prevent the occurrence of type I endoleaks, it is also possible to prevent the occurrence of type III to type IV endoleaks. Because type III endoleaks refer to the endoleaks caused by the rupture of the coating layer on the stent, and After the coating layer on the traditional stent is ruptured, the tumor cavity will directly communicate with the blood flow in the blood vessel without any obstruction. However, after the spongy layer is added in the present invention, even if the coating layer is ruptured, the blood in the tumor cavity and blood vessels will There is also a layer of sponge layer between them. Since the sponge layer is a porous structure, the blood flow rate will be greatly reduced when entering the porous structure, so it can effectively prevent the blood from rushing into the tumor cavity quickly, causing the tumor cavity to rupture. At the same time, The blood remaining in the spongy layer slows down due to the slow flow rate, and the spongy structure can absorb coagulation factors and platelets, so that the blood that penetrates into the spongy structure forms a blood clot, so after a period of time, the spongy layer and the coagulated blood clot inside it Play the role of completely sealing the tumor cavity. In the same way, due to the existence of the sponge layer, Type IV and V endoleaks can also be effectively prevented.
此外，本发明的覆膜层也可以覆盖于金属网状支撑层的内侧，从而弹性网格层与金属网状支撑层直接连接，此种层叠顺序亦能达到本发明的技术效果。In addition, the coating layer of the present invention can also cover the inner side of the metal mesh support layer, so that the elastic mesh layer is directly connected to the metal mesh support layer, and this lamination sequence can also achieve the technical effect of the present invention.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410817691.4ACN104873303B (en) | 2014-12-19 | 2014-12-19 | The anti-interior leakage stent graft system of attached sponge structure |
| PCT/CN2015/097972WO2016095864A1 (en) | 2014-12-19 | 2015-12-18 | Endoleak-preventing stent graft system |
| US15/537,429US11007047B2 (en) | 2014-12-19 | 2015-12-18 | Endoleak preventing stent graft system |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410817691.4ACN104873303B (en) | 2014-12-19 | 2014-12-19 | The anti-interior leakage stent graft system of attached sponge structure |
| Publication Number | Publication Date |
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| CN104873303Atrue CN104873303A (en) | 2015-09-02 |
| CN104873303B CN104873303B (en) | 2018-08-21 |
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| CN201410817691.4AExpired - Fee RelatedCN104873303B (en) | 2014-12-19 | 2014-12-19 | The anti-interior leakage stent graft system of attached sponge structure |
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| CN (1) | CN104873303B (en) |
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