CN211723545U - A stent-graft for aortic dissection with insufficient anchoring zone - Google Patents
A stent-graft for aortic dissection with insufficient anchoring zone Download PDFInfo
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Abstract
本实用新型属于医疗器械领域,涉及一种覆膜支架,特别涉及一种用于主动脉夹层锚定区不足的覆膜支架。其主体结构包括支架和膜两部分;支架由支撑环和连接筋组成,单个支撑环是由多个类N型支撑体组成,支撑环与支撑环之间分别由两种S型连接筋相间连接;圆筒型覆膜部分在近心端处周向开有狭缝。其特别适用于锚定区不足的主动脉夹层病变,对主动脉的支撑效果好,对血管壁的损伤小,同时具有良好的柔顺性;对于锚定区不足的情况,覆膜支架近心端突入左锁骨下动脉,近心端覆膜部分具有狭缝,可以在维持主动脉分支血流的同时,积极改变主动脉弓的血流动力学情况,有利于夹层中血栓的形成,避免了在分支部位“开窗”植入分支支架的步骤,可操作性高。
The utility model belongs to the field of medical devices and relates to a covered stent, in particular to a covered stent used for aortic dissection with insufficient anchoring area. Its main structure includes a bracket and a membrane; the bracket consists of a support ring and connecting ribs, a single support ring is composed of a plurality of N-type supports, and the support ring and the support ring are respectively connected by two S-type connecting ribs. ; The cylindrical membrane portion has a circumferential slit at the proximal end. It is especially suitable for aortic dissection lesions with insufficient anchoring area. It has a good supporting effect on the aorta, less damage to the vessel wall, and has good flexibility. For the insufficient anchoring area, the proximal end of the covered stent It protrudes into the left subclavian artery, and the membrane at the proximal end has a slit, which can actively change the hemodynamics of the aortic arch while maintaining the blood flow of the aortic branch, which is conducive to the formation of thrombus in the dissection and avoids the occurrence of thrombus in the branch. The steps of "opening the window" to implant branch stents are highly maneuverable.
Description
技术领域:Technical field:
本实用新型涉及医疗器械技术领域,特别涉及一种用于锚定区不足的主动脉夹层覆膜支架。The utility model relates to the technical field of medical devices, in particular to an aortic dissection covered stent for insufficient anchoring area.
背景技术:Background technique:
在现代社会下生活的人们,由于生活压力大、作息不规律和饮食不健康等原因,心血管疾病已经成为了临床上的常见疾病,其中胸主动脉夹层(thoracic aorticdissection,TAD)是目前较常见的一种非常凶险的心血管疾病。主要是指主动脉内膜及部分中膜被撕裂导致血管壁分层,血液通过被撕裂的内膜破口进入主动脉中层形成真假两腔,死亡率极高,约占心血管疾病的30%—35%。People living in modern society, due to high life pressure, irregular work and rest and unhealthy diet, cardiovascular disease has become a common clinical disease, among which thoracic aortic dissection (TAD) is currently the more common A very dangerous cardiovascular disease. Mainly refers to the tearing of the aortic intima and part of the media, which leads to the stratification of the blood vessel wall, and the blood enters the aortic media through the torn intima to form two true and false lumens. 30%-35% of the
主动脉腔内修复术被广泛用来治疗主动脉夹层,但在覆膜支架植入过程当中面临诸多难题。一方面,由于主动脉夹层常累及主动脉弓部,这就需要植入弯曲血管支架,支架具有良好的柔顺性能;为了使支架上的覆膜具有良好的贴壁性,还需要支架具有足够的支撑性能。另一方面,腔内修复术要想达到封堵夹层破口的效果,支架的近心端支撑区必须要有正常的动脉壁结构。而左锁骨下动脉开口部位结构稳定性主要依赖周围组织完整性,当主动脉累及左锁骨下动脉时,以此区域为支撑区域会导致支架撕开夹层内膜血液进入假腔,风险极大。如将支撑区域向近心端迁移势必会导致分支被封堵,出现脑部缺血等并发症。现阶段对于锚定区不足解决此类问题的主要办法是在分支中植入分支支架,以保护和加固受累及的分之动脉。分支支架的引入必然会涉及到与主干支架相对的空间位置关系的多种情况,外科手术难度大、操作困难、手术时间长、创伤大,且死亡率高。另外,手术中视野内管道多且顺序复杂,吻合口多,手术时间长导致脑缺血时间和体外循环时间相应延长,从而增加了手术死亡率和脑部并发症。中国专利CN200820079059.4提供了一种具有正弦型连接段及交互排列形支撑段的钴铬合金冠状动脉支架设计,能实现支架的均匀扩张,具有较好的径向强度,但其在弯曲的血管中释放缺乏一定的柔顺性能,其支撑性能和柔顺性能得不到同时满足。中国专利CN201420620618.3能封堵隔绝假腔破口,并主动缩小假腔空间,改变假腔内的血流速度和流量,确保假腔在期望时间内快速形成血栓,且向外侧膨出部分可有效地防止支架植入人体后由于血流冲击所产生的位移和滑动,避免因支架的位移暴露原动脉破口所产生的疾病复发,但其不适用于锚定区不足的主动脉夹层。Endovascular aortic repair is widely used to treat aortic dissection, but it faces many challenges during stent graft implantation. On the one hand, since aortic dissection often involves the aortic arch, a curved vascular stent needs to be implanted, and the stent has good compliance performance; in order to make the coating on the stent have good adherence, the stent also needs to have sufficient supporting performance . On the other hand, in order to achieve the effect of sealing the dissection rupture, the proximal support area of the stent must have a normal arterial wall structure. The structural stability of the opening of the left subclavian artery mainly depends on the integrity of the surrounding tissue. When the aorta involves the left subclavian artery, using this area as a support area will cause the stent to tear the dissection intima and blood into the false lumen, which is extremely risky. If the support area is migrated to the proximal end, the branch will be blocked, resulting in complications such as cerebral ischemia. At present, the main way to solve such problems for insufficient anchoring area is to implant branch stents in branches to protect and strengthen the involved branch arteries. The introduction of branch stents will inevitably involve a variety of situations in relation to the relative spatial position of the trunk stents. The surgical operation is difficult, the operation is difficult, the operation time is long, the trauma is large, and the mortality rate is high. In addition, during the operation, there are many pipelines in the field of view and the sequence is complicated, and there are many anastomotic sites. The long operation time leads to the corresponding prolongation of the cerebral ischemia time and the cardiopulmonary bypass time, thereby increasing the operative mortality and cerebral complications. Chinese patent CN200820079059.4 provides a cobalt-chromium alloy coronary stent design with sinusoidal connecting sections and alternately arranged support sections, which can achieve uniform expansion of the stent and has good radial strength, but it is not suitable for curved blood vessels The medium release lacks a certain degree of flexibility, and its support performance and flexibility cannot be satisfied at the same time. Chinese patent CN201420620618.3 can block and isolate the false lumen rupture, and actively reduce the false lumen space, change the blood flow velocity and flow in the false lumen, and ensure that the false lumen quickly forms thrombus within the desired time, and the bulging part can be It can effectively prevent the displacement and sliding caused by the impact of blood flow after the stent is implanted into the human body, and avoid the recurrence of the disease caused by the exposure of the original artery rupture due to the displacement of the stent, but it is not suitable for aortic dissection with insufficient anchoring area.
因此,寻求设计一种实现能够在弯曲血管中安全释放,并且有效封堵夹层破口,积极改善血管内的血流状态的新型覆膜支架是十分有必要的。Therefore, it is very necessary to seek to design a new type of stent-graft that can be safely released in tortuous blood vessels, effectively block the dissection rupture, and actively improve the blood flow in the blood vessel.
发明内容SUMMARY OF THE INVENTION
本实用新型的发明目的在于克服现有现有技术存在的缺点,寻求设计一种对血管壁的损伤小且具有良好支撑性,柔顺性,同时对于锚定区不足的情况,可以在维持主动脉上支血流的同时,积极改变主动脉弓的血流动力学情况的主动脉夹层覆膜支架。The purpose of the invention of the present invention is to overcome the shortcomings of the prior art, seek to design a kind of small damage to the blood vessel wall, and has good support and flexibility. The stent graft for aortic dissection actively changes the hemodynamics of the aortic arch while increasing the blood flow of the upper branch.
为实现上述发明目的,本实用新型所述的对于锚定区不足的主动脉夹层覆膜支架,由若干个类N型支撑体,分别沿周向和轴向按照一定的排列方式构成,并在支架表面包覆有带狭缝的覆膜。In order to achieve the above-mentioned purpose of the invention, the stent-graft for aortic dissection with insufficient anchoring area according to the present invention is composed of several N-type supports, which are respectively arranged in a certain manner along the circumferential direction and the axial direction, and are arranged in a certain manner in the circumferential direction and the axial direction. The surface of the stent is covered with a membrane with slits.
所述类N型支撑体,是支架最基本的单元,所有的组成杆件均由直径不等的圆弧连接而成。使得支架整体均由若干圆弧连接,以避免出现尖锐角,对血管壁造成损伤。The N-type support is the most basic unit of the stent, and all the constituent rods are connected by arcs with different diameters. The whole stent is connected by several arcs, so as to avoid sharp angles and damage to the blood vessel wall.
所述的支撑环与支撑环之间,由两种S连接筋间断相连。The support ring and the support ring are intermittently connected by two kinds of S connecting ribs.
所述第一种S型连接筋,为带双杆S型连接筋,双杆分别与前一支撑环浅波谷的顶点和后一支撑环低波峰的顶点相连,每隔两个浅波谷或低波峰出现一次。由于与此连接筋相连的两支撑环之间的浅波谷和低波峰相距较远,在保证支架足够的支撑强度的前提下,沿周向每隔两个浅波谷或低波峰设置一个带双杆S型连接筋,使得支架能够在弯曲血管中顺利释放,这一部分支架结构相对主要起柔顺作用。The first S-shaped connecting rib is an S-shaped connecting rib with double rods, and the double rods are respectively connected with the apex of the shallow wave trough of the former support ring and the apex of the low wave crest of the latter support ring, and every two shallow wave troughs or low wave troughs are connected. The crest appears once. Since the shallow wave troughs and low wave crests between the two support rings connected to this connecting rib are far apart, on the premise of ensuring sufficient support strength of the support, a double rod with double rods is arranged every two shallow wave troughs or low wave crests along the circumferential direction. The S-shaped connecting rib enables the stent to be released smoothly in the curved blood vessel, and this part of the stent structure mainly plays a compliant role.
所述第二种S型连接筋,为无双杆S型连接筋,在连接筋的两端分别与前一支撑环深波谷圆弧的左端点和后一支撑环高波峰圆弧的右端点相连。由于与此连接筋相连的两支撑环之间的深波谷和高波峰相距较近,在保证支架有足够的柔顺性能的前提下,沿周向每隔三个浅波谷或低波峰设置一个无双杆S型连接筋,使得支架在血管中顺利释放时支架上的覆膜贴壁型良好,这一部分支架结构相对主要起支撑作用。The second type of S-shaped connecting rib is a double-bar S-shaped connecting rib, and the two ends of the connecting rib are respectively connected with the left end point of the deep wave valley arc of the previous support ring and the right end point of the high wave crest arc of the latter support ring. . Since the deep wave troughs and high wave crests between the two support rings connected to the connecting rib are relatively close, on the premise of ensuring the support has sufficient compliance performance, a double-free rod is set every three shallow wave troughs or low wave crests along the circumferential direction. The S-shaped connecting rib enables the stent to adhere well to the wall when the stent is released smoothly in the blood vessel, and this part of the stent structure relatively mainly plays a supporting role.
所述主动动脉夹层覆膜支架整体形成一个闭环结构。The stent-graft for aortic dissection as a whole forms a closed-loop structure.
本实用新型中的覆膜在近心端周向开有狭缝,至于狭缝的尺寸,应根据分支的直径和分支处主动脉的直径合理设置,并将狭缝沿周向方向合理均布;轴向根据覆膜支架突入左锁骨下动脉的深度合理设置狭缝的间隔以及数量。使得所述覆膜支架在植入锚定区不足的主动脉夹层中,在分支血流入口处的血流保持良好状态。The membrane in the present invention is provided with slits in the circumferential direction of the proximal end. As for the size of the slits, it should be reasonably set according to the diameter of the branch and the diameter of the aorta at the branch, and the slits are reasonably and uniformly distributed along the circumferential direction; According to the depth of the stent-graft protruding into the left subclavian artery, the interval and number of slits were reasonably set. Therefore, in the aortic dissection with insufficient implantation anchoring area, the blood flow at the branch blood flow inlet of the stent-graft is kept in a good state.
本实用新型与现有技术相比,其特别适用于锚定区不足的主动脉夹层,对主动脉的支撑效果好,对血管壁的损伤小,同时满足在弯曲主动脉的弓部顺利释放,主动脉覆膜支架的柔顺性进一步提高。此外,对于锚定区不足的情况,覆膜支架近心端突入左锁骨下动脉,由于所述覆膜部分具有狭缝,可以在维持主动脉分支血流的同时,积极改变主动脉弓的血流动力学情况,有利于夹层中血栓的形成,省去了在分支部位“开窗”或是植入分支支架的步骤,操作简便。Compared with the prior art, the utility model is particularly suitable for aortic dissection with insufficient anchoring area, has good supporting effect on the aorta, less damage to the blood vessel wall, and at the same time satisfies the smooth release in the arch of the curved aorta, The flexibility of the aortic stent-graft is further improved. In addition, in the case of insufficient anchoring area, the proximal end of the stent-graft protrudes into the left subclavian artery. Since the covered part has a slit, it can actively change the blood flow of the aortic arch while maintaining the blood flow of the aortic branch. It is beneficial to the formation of thrombus in the dissection, and the steps of "opening a window" or implanting a branch stent at the branch site are omitted, and the operation is simple.
附图说明:Description of drawings:
图1为本实用新型主动脉夹层覆膜支架的平面结构示意图;Fig. 1 is the plane structure schematic diagram of the stent-graft for aortic dissection of the present invention;
图2为本实用新型主动脉夹层覆膜支架的单个类N型支撑单体放大图;2 is an enlarged view of a single N-type support unit of the stent-graft for aortic dissection of the present invention;
图3为本实用新型涉及连接相对主要起柔顺作用支撑环的带双杆S型连接筋示意图;Figure 3 is a schematic diagram of the S-shaped connecting rib with double rods related to the connection of the relatively main supporting ring with a compliant function of the present invention;
图4为本实用新型涉及连接相对主要起支撑作用支撑环的无双杆S型连接筋示意图;FIG. 4 is a schematic diagram of the S-shaped connecting rib without double rods related to the connection of the relatively main supporting ring of the present invention; FIG.
图5为本实用新型涉及带狭缝覆膜的平面展开图。FIG. 5 is a plan development view of the utility model relating to a film with a slit.
图中:1-深波谷,2-浅波谷,3-低波峰,4-高波峰,5-类N型支撑体,6-第一支撑环,7-带双杆S型连接筋,8-无双杆S型连接筋,9-第二支撑环,10-第三支撑环,11-带狭缝的覆膜。In the figure: 1-deep wave trough, 2-shallow wave trough, 3-low wave crest, 4-high wave crest, 5-type N-type support, 6-first support ring, 7-with double-bar S-type connecting rib, 8- No double-bar S-shaped connecting rib, 9-second support ring, 10-third support ring, 11-film with slits.
具体实施方式:Detailed ways:
下面通过具体实施例和附图对本实用新型作进一步的阐述。The present utility model will be further elaborated below through specific embodiments and accompanying drawings.
实施例1:Example 1:
本实施例所述的适用于锚定区不足的主动脉夹层覆膜支架,其主体结构包括:体结构包括支架和覆膜11两部分。支架部分沿轴向由多个支撑环和连接筋组成。第一支撑环6主要由类N型支撑单体5沿周向按照一定次序顺次连接,轴向各支撑环同样是将类N型支撑单体5按照一定次序顺次连接构成支架主体部分。相邻第一支撑环6和第二支撑环9由带双杆S型连接筋7的双杆依次连接第一支撑环6浅波谷2的顶点和第二支撑环9低波峰3的顶点,每隔两个浅波谷2或低波峰3出现一次;相邻第二支撑环9和第三支撑环10由无双杆S型连接筋7的两端依次连接第二支撑环9深波谷1圆弧的左端点和第三支撑环10高波峰4圆弧的右端点,沿周向每隔三个浅波谷2或低波峰3设置一个无双杆S型连接筋。所述图5带狭缝的覆膜11可按照一定规则缝合在支架上。The stent-graft for aortic dissection described in this embodiment is suitable for insufficient anchoring area, and its main structure includes: the body structure includes two parts: the stent and the
与现有技术相比,该发明优势在于:本实用新型所涉及的主动脉夹层覆膜支架对于锚定区不足的主动脉夹层,对主动脉的支撑效果好,对血管壁的损伤小,同时满足在弯曲主动脉的弓部顺利释放,主动脉覆膜支架的柔顺性进一步提高。此外,对于锚定区不足的情况,覆膜支架近心端突入左锁骨下动脉,由于所述覆膜部分具有狭缝,可以在维持主动脉上支血流的同时,积极改变主动脉弓的血流动力学情况。既有封堵隔绝假腔破口作用,又可以通过改变假腔内血流状态,有利于夹层中血栓在期望时间内快速形成,省去了在分支部位“开窗”或是植入分支支架的步骤,操作简便。Compared with the prior art, the advantages of the invention are: the stent-graft for aortic dissection involved in the present utility model has good supporting effect on the aorta for aortic dissection with insufficient anchoring area, less damage to the blood vessel wall, and at the same time. Satisfying the smooth release in the arch of the curved aorta, the flexibility of the stent-graft is further improved. In addition, in the case of insufficient anchoring area, the proximal end of the stent-graft protrudes into the left subclavian artery. Since the covered part has a slit, it can actively change the blood flow of the aortic arch while maintaining the blood flow of the superior aortic branch. dynamic situation. It not only blocks and isolates the rupture of the false lumen, but also can change the blood flow state in the false lumen, which is conducive to the rapid formation of thrombus in the dissection within the desired time, eliminating the need for "windowing" at the branch site or implanting branch stents steps, easy to operate.
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CN115363818A (en) * | 2022-09-14 | 2022-11-22 | 北京宥安医疗科技有限公司 | A kind of stent graft and manufacturing method thereof |
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CN115363818A (en) * | 2022-09-14 | 2022-11-22 | 北京宥安医疗科技有限公司 | A kind of stent graft and manufacturing method thereof |
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