技术领域technical field
本实用新型涉及医疗器械制造技术领域的一种采用经皮冠状动脉腔内血管支架介入术治疗颈动脉、股动脉以及其他具有侧枝分叉的冠状动脉病变血管的球囊扩张式血管支架，具体涉及一种阶梯形球囊扩张式血管支架。The utility model relates to a balloon-expandable vascular stent for the treatment of carotid artery, femoral artery and other coronary arterial lesion vessels with side branches and bifurcations by adopting percutaneous coronary artery vascular stent intervention in the technical field of medical device manufacturing, specifically relating to A step-shaped balloon-expandable blood vessel stent.
背景技术Background technique
如今，心脑血管疾病患者日益增多，世界卫生组织表明心血管疾病也已经成为危害人类生命安全最严重的疾病，其中冠心病的发病率和死亡率居各类疾病之首。目前，由于颅外颈动脉粥样硬化性狭窄所致的缺血性死亡也逐步增长，支架植入术因其高效、微创等特性已成为一种有效的、替代颈动脉内膜切除手术治疗颈动脉疾病的方式。冠状动脉侧枝血管形成可减少心肌梗死的面积，阻止左室室壁瘤的形成，改善心功能。但侧枝血管一旦阻塞会狭窄，便会引发各类急性血管病变。而且支架内再狭窄和支架血栓形成仍然是支架介入术较严重的并发症。因此，针对治疗颈动脉、股动脉或者具有分叉的冠状动脉病变血管介入心脏病学仍然是一个持续的挑战。Nowadays, the number of patients with cardiovascular and cerebrovascular diseases is increasing. The World Health Organization indicates that cardiovascular disease has become the most serious disease that endangers human life safety. Among them, the morbidity and mortality of coronary heart disease rank first among all kinds of diseases. At present, ischemic death due to extracranial carotid atherosclerotic stenosis is gradually increasing, and stent implantation has become an effective alternative to carotid endarterectomy because of its high efficiency and minimal invasiveness. Ways of Carotid Artery Disease. Coronary collateral vessel formation can reduce the size of myocardial infarction, prevent the formation of left ventricular aneurysm, and improve cardiac function. However, once the collateral vessels are blocked, they will be narrowed, which will lead to various acute vascular diseases. Moreover, in-stent restenosis and stent thrombosis are still serious complications of stent intervention. Thus, interventional cardiology remains a continuing challenge in vascular interventional cardiology for the treatment of carotid, femoral, or coronary artery lesions with bifurcations.
血管支架介入术治疗方法是将经激光雕刻而成的血管支架预先压握装在折叠好的球囊上，然后随着球囊一起沿着引导刚丝到达病变部位，接着球囊膨胀，对支架进行扩张以便撑开狭窄的血管，从而恢复血流畅通。因为传统的血管支架在膨胀前后都为圆柱状，但人体血管的形状是千变万化的，例如一些颈动脉、股动脉都是一些长度较长、弯曲程度高，此时采用传统的不变径的冠状动脉支架不能满足侧枝分叉的病变血管。采用传统的支架治疗分叉病变血管所带来的危害：不变径的圆柱形血管支架扩张侧枝分叉血管便会过度扩张血管，导致血管壁的损伤，引发支架内再狭窄。同时也会出现支架贴壁不良现象，支架贴壁不良会导致经皮冠状动脉支架介入术并发症的发生，从而引发支架血栓的形成。支架贴壁不良是指血管支架与血管壁接触不完全，且贴壁不良的血管支架与血管内膜愈合延迟、不完整的内皮化和高度的血栓沉积密切相关。The treatment method of vascular stent intervention is to press and hold the laser-engraved vascular stent in advance and install it on the folded balloon. Dilation is performed to open narrowed blood vessels and restore blood flow. Because traditional vascular stents are cylindrical before and after expansion, but the shape of human blood vessels is ever-changing, for example, some carotid arteries and femoral arteries are long in length and highly curved. Arterial stents cannot satisfy diseased blood vessels with side branches. Harm caused by the use of traditional stents to treat bifurcated diseased blood vessels: cylindrical vascular stents with constant diameter expand side branches and bifurcated blood vessels will over-expand the blood vessels, resulting in damage to the vessel wall and causing in-stent restenosis. At the same time, the phenomenon of stent malapposition will also occur, which will lead to the occurrence of complications of percutaneous coronary stent intervention, thereby triggering the formation of stent thrombosis. Stent malapposition refers to incomplete contact between the stent and the vessel wall, and poorly adhered stents are closely related to delayed intima healing, incomplete endothelialization, and high thrombus deposition.
支架介入术的最佳治疗效果很大程度上与血管支架的结构性能参数有关。目前市场与临床上对支架的结构设计多采用参数值一致的设计，即血管支架结构为统一的圆柱状，支架段的扩张口径一致，并且采用相同形状的环状支撑体，即环状支撑体单元波的波高与宽度一致，这使得整个支架在扩张时呈现一致的圆柱状，对血管直径相差较大的分叉血管的支流血管壁造成严重损伤。即使在采用了阶梯形球囊的情况下，仍存在一些不足之处，例如：采用传统的支架用在梯形球囊上，当支架完全扩张后，在与梯形球囊大口径端相接触处的支架应力往往较大，而在与梯形球囊小口径端相接触处的支架应力往往较小，由于整个支架上的应力分布严重不均很容易诱发支架的疲劳破坏，从而大大缩短支架的服役年限即使用寿命。The optimal therapeutic effect of stent intervention is largely related to the structural performance parameters of vascular stents. At present, the structural design of the stent in the market and clinically adopts the design with the same parameter value, that is, the structure of the vascular stent is uniform cylindrical, the expansion diameter of the stent section is the same, and the ring support body of the same shape is used, that is, the ring support body The wave height and width of the unit wave are consistent, which makes the whole stent present a consistent cylindrical shape when expanded, causing serious damage to the tributary vessel wall of the bifurcated vessel with a large difference in vessel diameter. Even when the stepped balloon is used, there are still some shortcomings, for example: the traditional stent is used on the trapezoidal balloon. The stress of the stent is often large, while the stress of the stent in the contact with the small-diameter end of the trapezoidal balloon is often small. Due to the serious uneven stress distribution on the entire stent, it is easy to induce fatigue damage to the stent, thereby greatly shortening the service life of the stent That is, the service life.
实用新型内容Utility model content
本实用新型的目的是为了解决现有技术中的不足，而提供一种阶梯形球囊扩张式血管支架，适用于颈动脉、股动脉以及其他具有侧枝的冠状动脉分叉病变血管，通过改变支架段的扩张口径、阶梯数、单元波的波高与波宽以及支架段之间过渡区的连接方式，兼顾了血管支架轴向上的柔顺性和支架径向回弹率，在延长血管支架使用寿命的同时可以防止血管支架贴壁不良性和血管支架血栓等介入术后并发症的出现。The purpose of this utility model is to solve the deficiencies in the prior art, and to provide a ladder-shaped balloon-expandable vascular stent, which is suitable for carotid artery, femoral artery and other coronary arteries with side branches. The expansion diameter of the segment, the number of steps, the wave height and width of the unit wave, and the connection mode of the transition zone between the stent segments take into account the flexibility of the stent in the axial direction and the radial resilience of the stent, and prolong the service life of the stent At the same time, it can prevent the occurrence of post-intervention complications such as vascular stent malapposition and vascular stent thrombosis.
本实用新型的技术方案是：一种阶梯形球囊扩张式血管支架，包括N个扩张口径不同的支架段，相邻的所述支架段通过过渡区连接筋连接；The technical solution of the utility model is: a ladder-shaped balloon-expandable vascular stent, comprising N stent sections with different expansion calibers, and the adjacent stent sections are connected by connecting ribs in transition areas;
所述支架段包括若干个环状支撑体，相邻的所述环状支撑体之间通过支撑体连接筋连接；所述环状支撑体沿所述血管支架轴向依次排列，相邻的所述环状支撑体之间呈镜面对称分布，每个环状支撑体包括若干形状相同的正弦单元波，所述单元波沿所述血管支架的周向依次排列。The stent segment includes several ring-shaped supports, and the adjacent ring-shaped supports are connected by support body connecting ribs; the ring-shaped supports are arranged in sequence along the axial direction of the vascular stent, and the adjacent ring-shaped supports The ring-shaped supports are distributed mirror-symmetrically, and each ring-shaped support includes several sinusoidal unit waves of the same shape, and the unit waves are arranged in sequence along the circumference of the vascular stent.
上述方案中，所述N＝3，3个所述支架段分别为第一支架段、第二支架段和第三支架段；每个所述支架段均包括四个环状支撑体，每个所述环状支撑体均包括六个所述单元波。In the above scheme, the N=3, the three stent segments are respectively the first stent segment, the second stent segment and the third stent segment; each of the stent segments includes four annular supports, each Each of the annular supports includes six of the unit waves.
进一步的，所述第三支架段的扩张口径为d，所述第二支架段的扩张口径为(1.2～1.4)d，所述第一支架段的扩张口径为(1.6～1.8)d。Further, the expansion diameter of the third stent segment is d, the expansion diameter of the second stent segment is (1.2-1.4) d, and the expansion diameter of the first stent segment is (1.6-1.8) d.
进一步的，所述第三支架段的正弦单元波的宽度为W，所述第二支架段的单元波宽度为(0.6～0.9)W，所述第三支架段的单元波宽度为(0.3～0.6)W。Further, the width of the sinusoidal unit wave of the third stent segment is W, the unit wave width of the second stent segment is (0.6-0.9) W, and the unit wave width of the third stent segment is (0.3-0.9) W. 0.6) W.
上述方案中，所述第三支架段的正弦单元波的波高为H，所述第二支架段的单元波波高为(1.5～2)H，所述第一支架段的单元波波高为(2～2.5)H。In the above scheme, the wave height of the sinusoidal element wave of the third support section is H, the wave height of the element wave of the second support section is (1.5～2)H, and the wave height of the element wave of the first support section is (2) ~2.5) H.
上述方案中，所述支撑体连接筋为直线型连接筋。In the above solution, the connecting ribs of the support body are linear connecting ribs.
上述方案中，所述过渡区连接筋为拱形连接筋、S型连接筋、M型连接筋中的任意一种。In the above solution, the connecting bars in the transition zone are any one of arched connecting bars, S-shaped connecting bars, and M-shaped connecting bars.
上述方案中，相邻的所述支架段通过所述过渡区连接筋错位连接或者连接方向与所述血管支架轴向方向一致。In the above solution, the adjacent stent segments are connected via dislocation of the connecting ribs in the transition region or the connection direction is consistent with the axial direction of the vascular stent.
本实用新型与现有技术相比具有以下有益效果：Compared with the prior art, the utility model has the following beneficial effects:
1、本实用新型改变了所述支架段的扩张口径，扩张口径的大小不同，采用阶梯形球囊进行扩张血管，使得扩张后的所述血管支架与阶梯形球囊相匹配，适合侧枝分叉型病变血管，保证了扩张后的血管支架应力分布均匀兼顾了血管支架使用的可靠性以及延长了血管支架的使用寿命。1. The utility model changes the expansion caliber of the stent section, and the expansion caliber is different in size. A stepped balloon is used to expand the blood vessel, so that the expanded vascular stent matches the stepped balloon, which is suitable for side branch bifurcation Type diseased blood vessels ensure uniform stress distribution of the expanded vascular stent, take into account the reliability of the vascular stent and prolong the service life of the vascular stent.
2、本实用新型增加了所述第二支架段与所述第三支架段环状支撑体单元波的宽度，降低了所述血管支架的径向回弹率兼顾了支架梯度的形成，使得所述血管支架与人体血管贴壁性能得到改善，以降低支架血栓的发生率。2. The utility model increases the width of the ring-shaped support element wave of the second stent section and the third stent section, reduces the radial spring rate of the vascular stent and takes into account the formation of the stent gradient, so that the The adhesion performance between the vascular stent and the human blood vessel is improved, so as to reduce the incidence of stent thrombosis.
3、本实用新型增加了所述第一支架段与所述第二支架段环状支撑体的单元波波高，保证所述血管支架撑开后整体金属覆盖的一致性兼顾了所述血管支架的轴向缩短率，满足了侧枝分叉病变血管所需支架长度的有效选用与定位的精确度。3. The utility model increases the unit wave height of the annular support body of the first stent segment and the second stent segment, to ensure the consistency of the overall metal coverage after the vascular stent is stretched and to take into account the stability of the vascular stent. The axial shortening rate satisfies the effective selection and positioning accuracy of the stent length required for side branch bifurcation disease vessels.
4、本实用新型改变了所述环状支撑体之间的连接筋形状和连接方向，即相邻的环状支撑体之间采用直线型连接筋连接，且所述直线型连接筋的连接方向与所述血管支架轴向一致，既能保证所述第三支架段的纵向强度又能兼顾所述血管支架整体的轴向缩短性，在相邻的所述支架段之间采用拱形连接筋或S型连接筋或M型连接筋中的任意一种，采用错位连接方式，使轴向应力分散以保证球囊膨胀时所述血管支架呈现阶梯形时所述过渡区的突变状态，兼顾了所述血管支架纵向上的纵向强度和柔顺性。4. The utility model changes the shape and connection direction of the connecting ribs between the annular supports, that is, the adjacent annular supports are connected by linear connecting ribs, and the connecting direction of the linear connecting ribs Axially consistent with the vascular stent, it can not only ensure the longitudinal strength of the third stent segment but also take into account the overall axial shortening of the vascular stent, and adopt arched connecting ribs between adjacent stent segments Or any one of the S-shaped connecting ribs or the M-shaped connecting ribs, the dislocation connection method is used to disperse the axial stress to ensure the sudden change of the transition zone when the vascular stent presents a stepped shape when the balloon is inflated, taking into account the The longitudinal strength and flexibility of the vascular stent in the longitudinal direction.
附图说明Description of drawings
图1是本实用新型实施例一的血管支架沿轴向展开后的结构示意图；Fig. 1 is a schematic diagram of the structure of the vascular stent in the first embodiment of the present invention after it is deployed in the axial direction;
图2是本实用新型实施例二的血管支架沿轴向展开后的结构示意图；Fig. 2 is a structural schematic diagram of the vascular stent in the second embodiment of the present invention after being deployed in the axial direction;
图3是本实用新型实施例三的血管支架结构示意图。Fig. 3 is a schematic diagram of the structure of the vascular stent in the third embodiment of the present invention.
图中，1、第一环状支撑体；2、第二环状支撑体；3、第三环状支撑体；4、第四环状支撑体；5、第五环状支撑体；6、第六环状支撑体；7、第七环状支撑体；8、第八环状支撑体；9、第九环状支撑体；10、第十环状支撑体；11、第十一环状支撑体；12、第十二环状支撑体；13、第一直线型连接筋；14、第二直线型连接筋；15、第三直线型连接筋；16、第四直线型连接筋；17、第五直线型连接筋；18、第六直线型连接筋；19、第七直线型连接筋；20、第八直线型连接筋；21、第九直线型连接筋；22、第一拱形连接筋；23、第二拱形连接筋；24、单元波；25、S型连接筋；26、M型连接筋；27、第一支架段；28、第二支架段；29、第三支架段；30、第一过渡区；31、第二过渡区。In the figure, 1. the first annular support body; 2. the second annular support body; 3. the third annular support body; 4. the fourth annular support body; 5. the fifth annular support body; 6. The sixth annular support; 7. The seventh annular support; 8. The eighth annular support; 9. The ninth annular support; 10. The tenth annular support; 11. The eleventh annular support Support body; 12. The twelfth annular support body; 13. The first linear connecting rib; 14. The second linear connecting rib; 15. The third linear connecting rib; 16. The fourth linear connecting rib; 17. The fifth straight connecting rib; 18. The sixth straight connecting rib; 19. The seventh straight connecting rib; 20. The eighth straight connecting rib; 21. The ninth straight connecting rib; 22. The first arch 23, the second arch-shaped connecting rib; 24, unit wave; 25, S-shaped connecting rib; 26, M-shaped connecting rib; 27, the first bracket section; 28, the second bracket section; 29, the third Stent segment; 30, the first transition zone; 31, the second transition zone.
具体实施方式detailed description
下面结合附图具体实施方式对本实用新型作进一步详细说明，但本实用新型的保护范围并不限于此。The utility model will be described in further detail below in conjunction with the specific embodiments of the accompanying drawings, but the protection scope of the utility model is not limited thereto.
本实用新型所述的一种阶梯形球囊扩张式血管支架采用与其阶梯数相匹配的阶梯形球囊进行扩张，适用于颈动脉、股动脉以及其他具有侧枝的冠状动脉分叉病变血管，通过改变支架段的扩张口径、阶梯数、环状支撑体周向单元波的波高与波宽以及支架段之间过渡区的连接方式，兼顾血管支架轴向上的柔顺性和支架径向回弹率，在延长血管支架使用寿命的同时可以防止血管支架贴壁不良性和血管支架血栓等介入术后并发症的出现。A ladder-shaped balloon-expandable vascular stent described in the utility model is expanded by a ladder-shaped balloon that matches the number of steps, and is suitable for carotid arteries, femoral arteries, and other coronary artery bifurcation diseased blood vessels with side branches. Change the expansion diameter of the stent segment, the number of steps, the wave height and width of the circumferential unit wave of the annular support body, and the connection mode of the transition zone between the stent segments, taking into account the flexibility of the stent in the axial direction and the radial resilience of the stent , while prolonging the service life of the vascular stent, it can prevent the occurrence of post-interventional complications such as poor apposition of the vascular stent and thrombosis of the vascular stent.
所述阶梯形球囊扩张式血管支架经过阶梯形球囊扩张后呈阶梯形，包括N个扩张口径不同的支架段，相邻的所述支架段通过过渡区连接筋连接，N也等于所述血管支架的阶数。The stepped balloon-expandable vascular stent has a stepped shape after being expanded by the stepped balloon, and includes N stent segments with different expansion calibers. The adjacent stent segments are connected by connecting ribs in the transition zone, and N is also equal to the The order of vascular stents.
所述支架段包括若干个环状支撑体，相邻的所述环状支撑体之间通过支撑体连接筋连接；所述环状支撑体沿所述血管支架轴向依次排列，相邻的所述环状支撑体之间呈镜面对称分布，每个所述环状支撑体包括若干形状相同的正弦单元波24，所述单元波24沿所述血管支架的周向依次排列。The stent segment includes several ring-shaped supports, and the adjacent ring-shaped supports are connected by support body connecting ribs; the ring-shaped supports are arranged in sequence along the axial direction of the vascular stent, and the adjacent ring-shaped supports The ring-shaped supports are distributed mirror-symmetrically, and each ring-shaped support includes several sinusoidal unit waves 24 of the same shape, and the unit waves 24 are arranged in sequence along the circumferential direction of the vascular stent.
所述过渡区连接筋采用拱形连接筋或S型连接筋25或M型连接筋26中的任意一种。The connecting bars in the transition zone adopt any one of arched connecting bars or S-shaped connecting bars 25 or M-shaped connecting bars 26 .
所述支撑体连接筋为直线型连接筋。The connecting ribs of the support body are linear connecting ribs.
相邻的所述支架段通过所述过渡区连接筋错位连接，或者连接相邻所述支架段的过渡区连接筋连接方向与所述血管支架轴向一致。Adjacent stent segments are connected via dislocation of the connecting ribs in the transition area, or the connection direction of the connecting ribs in the transition area connecting the adjacent stent segments is consistent with the axial direction of the vascular stent.
所述血管支架根据分叉病变血管的形状及长度，选取所述血管支架的阶数，阶数N≥2。在分叉病变血管较短的情况下，可选用两阶支架段，在分叉病变血管较长，且弯曲程度较高的情况下，可选用三阶及三阶以上阶数的支架段。同时，通过增减每组支架段环状支撑体的组数和连接筋的个数达到增加或减小所述血管支架的长度以适应血管不同病变的长度与弯曲程度。The vascular stent selects the order of the vascular stent according to the shape and length of the bifurcated diseased blood vessel, and the order N≥2. In the case of a short bifurcation lesion vessel, a two-stage stent segment can be used, and in the case of a long bifurcation lesion vessel with a high degree of curvature, a three-stage or higher stent segment can be used. At the same time, the length of the vascular stent can be increased or decreased by increasing or decreasing the number of groups of ring-shaped supports and the number of connecting ribs in each group of stent segments to adapt to the length and curvature of different vascular lesions.
实施例一：图1所示为本实用新型所述阶梯形球囊扩张式血管支架的一种实施方式：三阶式血管支架，所述血管支架包括3个不同扩张口径的支架段，相邻的所述支架段通过过渡区连接，所述支架段扩张后所形成的阶梯数为3阶。Embodiment 1: Figure 1 shows an embodiment of the stepped balloon-expandable vascular stent of the present invention: a three-stage vascular stent, the vascular stent includes 3 stent segments with different expansion calibers, adjacent The stent segments are connected by a transition zone, and the number of steps formed after the stent segments are expanded is 3.
3个所述支架段分别为第一支架段27、第二支架段28和第三支架段29；相邻的所述支架段通过过渡区连接筋连接，相邻的所述支架段之间的连接区域为过渡区，所述第一支架段27与所述第二支架段28之间的连接区域为第一过渡区30，所述第二支架段28与所述第三支架段29之间的连接区域为第二过渡区31。每个所述支架段均包括四个所述环状支撑体，所述环状支撑体沿所述血管支架轴向依次排列，相邻的所述环状支撑体之间呈镜面对称分布。每个所述环状支撑体均包括六个所述单元波24，所述单元波24沿所述血管支架的周向依次排列。The 3 bracket sections are respectively the first bracket section 27, the second bracket section 28 and the third bracket section 29; the adjacent bracket sections are connected by the transition zone connecting ribs, and the adjacent bracket sections The connection area is a transition area, the connection area between the first bracket segment 27 and the second bracket segment 28 is a first transition area 30, and the connection area between the second bracket segment 28 and the third bracket segment 29 The connecting region of is the second transition region 31 . Each of the stent segments includes four annular supports, the annular supports are arranged in sequence along the axial direction of the vascular stent, and the adjacent annular supports are symmetrically distributed in a mirror-like manner. Each of the annular supports includes six unit waves 24 , and the unit waves 24 are arranged in sequence along the circumference of the vascular stent.
所述第一支架段27包括第一环状支撑体1、第二环状支撑体2、第三环状支撑体3和第四环状支撑体4；所述第二支架段28包括第五环状支撑体5、第六环状支撑体6、第七环状支撑体7和第八环状支撑体8；所述第三支架段29包括第九环状支撑体9、第十环状支撑体10、第十一环状支撑体11和第十二环状支撑体12。The first support section 27 includes a first annular support body 1, a second annular support body 2, a third annular support body 3 and a fourth annular support body 4; the second support section 28 includes a fifth annular support body Ring support body 5, the sixth ring support body 6, the seventh ring support body 7 and the eighth ring support body 8; the third bracket section 29 includes the ninth ring support body 9, the tenth ring support body The supporting body 10 , the eleventh annular supporting body 11 and the twelfth annular supporting body 12 .
所述第一环状支撑体1与所述第二环状支撑体2通过第一直线型连接筋13连接，所述第二环状支撑体2与所述第三环状支撑体3通过第二直线型连接筋14连接，所述第三环状支撑体3与所述第四环状支撑体4通过第三直线型连接筋15连接，所述第四环状支撑体4与所述第五环状支撑体5通过第一拱形连接筋22连接，所述第五环状支撑体5与所述第六环状支撑体6通过第四直线型连接筋16连接，所述第六环状支撑体6与所述第七环状支撑体7通过第五直线型连接筋17连接，所述第七环状支撑体7与所述第八环状支撑体8通过第六直线型连接筋18连接，所述第八环状支撑体8与所述第九环状支撑体9通过第二拱形连接筋23连接；所述第九环状支撑体9与所述第十环状支撑体10通过第七直线型连接筋19连接，所述第十环状支撑体10与所述第十一环状支撑体11通过第八直线型连接筋20连接，所述第十一环状支撑体11与所述第十二环状支撑体12通过第九直线型连接筋21连接。The first annular support body 1 and the second annular support body 2 are connected by a first linear connecting rib 13, and the second annular support body 2 and the third annular support body 3 pass through The second linear connecting rib 14 is connected, the third annular support body 3 is connected with the fourth annular supporting body 4 through the third linear connecting rib 15, and the fourth annular supporting body 4 is connected to the fourth annular supporting body 4. The fifth annular support body 5 is connected through the first arched connecting rib 22, the fifth annular support body 5 and the sixth annular support body 6 are connected through the fourth linear connecting rib 16, and the sixth annular support body 6 is connected through the fourth linear connecting rib 16. The annular support body 6 is connected with the seventh annular support body 7 through the fifth linear connecting rib 17, and the seventh annular support body 7 is connected with the eighth annular support body 8 through the sixth linear type Rib 18 is connected, and the eighth annular support body 8 is connected to the ninth annular support body 9 through a second arched connecting rib 23; the ninth annular support body 9 is connected to the tenth annular support body The body 10 is connected through the seventh straight connecting rib 19, the tenth annular support body 10 is connected with the eleventh annular supporting body 11 through the eighth straight connecting rib 20, and the eleventh annular support The body 11 is connected to the twelfth annular support body 12 through a ninth linear connecting rib 21 .
所述第三支架段29的扩张口径为d，所述第二支架段28的扩张口径为(1.2～1.4)d，所述第一支架段27的扩张口径为(1.6～1.8)d，扩张口径的大小不同，采用阶梯形球囊进行扩张血管，使得扩张后的所述血管支架与阶梯形球囊相匹配，适合侧枝分叉型病变血管，保证了扩张后的血管支架应力分布均匀兼顾了血管支架使用的可靠性以及延长了血管支架的使用寿命。The expansion caliber of the third stent segment 29 is d, the expansion caliber of the second stent segment 28 is (1.2-1.4) d, the expansion caliber of the first stent segment 27 is (1.6-1.8) d, and the expansion The caliber is different, and the stepped balloon is used to expand the blood vessel, so that the expanded vascular stent matches the stepped balloon, which is suitable for side branch and bifurcated diseased blood vessels, and ensures that the stress distribution of the expanded vascular stent is even. The reliability of the use of the vascular stent and the prolongation of the service life of the vascular stent.
本实用新型改变了所述环状支撑体之间的连接筋形状，即每组所述支架段相邻的环状支撑体之间采用直线型连接筋连接，且所述直线型连接筋的连接方向与所述血管支架轴向一致，既能保证所述第三支架段29的纵向强度又能兼顾所述血管支架整体的轴向缩短性。相邻的所述支架段之间的过渡区采用拱形连接筋连接，且采用错位连接的方式过渡连接，达到轴向应力分散效果以保证球囊膨胀时所述血管支架呈现阶梯形时所述过渡区的突变状态，兼顾了所述血管支架纵向上的纵向强度和柔顺性。The utility model changes the shape of the connecting ribs between the ring-shaped supports, that is, the adjacent ring-shaped supports of each group of the bracket sections are connected by linear connecting ribs, and the connecting direction of the linear connecting ribs is the same as The axial direction of the vascular stent is consistent, which can not only ensure the longitudinal strength of the third stent segment 29 but also take into account the overall axial shortening of the vascular stent. The transition area between the adjacent stent segments is connected by arched connecting ribs, and the transitional connection is adopted in the form of dislocation connection to achieve the effect of axial stress dispersion to ensure that the vascular stent presents a stepped shape when the balloon is inflated. The abrupt change state of the transition zone takes into account the longitudinal strength and flexibility of the vascular stent in the longitudinal direction.
本实用新型增加了所述第二支架段28与所述第三支架段29的环状支撑体单元波的宽度，所述第九环状支撑体9、第十环状支撑体10、第十一环状支撑体11和第十二环状支撑体12的单元波宽度为W，所述第五环状支撑体5、第六环状支撑体6、第七环状支撑体7和第八环状支撑体8的单元波宽度为(0.6～0.9)W，所述第一环状支撑体1、第二环状支撑体2、第三环状支撑体3和第四环状支撑体4的单元波宽度为(0.3～0.6)W，保证了血管支架的径向回弹率，使得所述血管支架与人体血管贴壁性能得到改善，以降低支架血栓的发生率。在实际应用中，所述单元波的宽度W可通过采用直接设计改变宽度达到或采用改变切割余量达到。The utility model increases the width of the annular support body unit wave of the second support section 28 and the third support section 29, the ninth annular support body 9, the tenth annular support body 10, the tenth annular support body The unit wave width of the first annular support body 11 and the twelfth annular support body 12 is W, and the fifth annular support body 5, the sixth annular support body 6, the seventh annular support body 7 and the eighth annular support body The unit wave width of the annular support body 8 is (0.6-0.9) W, and the first annular support body 1 , the second annular support body 2 , the third annular support body 3 and the fourth annular support body 4 The unit wave width of the vascular stent is (0.3-0.6) W, which ensures the radial resilience of the vascular stent, improves the wall-attachment performance of the vascular stent and human blood vessels, and reduces the incidence of stent thrombosis. In practical applications, the width W of the unit wave can be achieved by changing the width by direct design or by changing the cutting margin.
本实用新型增加了所述第一支架段27与所述第二支架段28环状支撑体的单元波波高，所述第九环状支撑体9、第十环状支撑体10、第十一环状支撑体11和第十二环状支撑体12的单元波波高为H，所述第五环状支撑体5、第六环状支撑体6、第七环状支撑体7、第八环状支撑体8的单元波波高为(1.5～2)H，所述第一环状支撑体1、第二环状支撑体2、第三环状支撑体3和第四环状支撑体4的单元波波高为(2～2.5)H，保证了所述血管支架的轴向缩短率，兼顾了侧枝分叉病变血管所需支架长度的有效选用与定位的精确度。The utility model increases the unit wave height of the first support section 27 and the second support section 28 annular support body, the ninth annular support body 9, the tenth annular support body 10, the eleventh annular support body The unit wave height of the annular support body 11 and the twelfth annular support body 12 is H, and the fifth annular support body 5, the sixth annular support body 6, the seventh annular support body 7, and the eighth annular support body The unit wave height of the ring-shaped support body 8 is (1.5～2) H, and the The wave height of the unit wave is (2-2.5) H, which ensures the axial shortening rate of the blood vessel stent, and takes into account the effective selection of the length of the stent required for side branch bifurcation disease vessels and the accuracy of positioning.
实施例二：图2所示为本实用新型所述阶梯形球囊扩张式血管支架的一种实施方式：二阶式血管支架，所述血管支架包括两个不同扩张口径的支架段，所述支架段扩张后所形成的阶梯数为两阶，相邻的所述支架段通过过渡区连接，所述过渡区采用M型连接筋26连接。Embodiment 2: Figure 2 shows an embodiment of the stepped balloon-expandable vascular stent of the present invention: a two-stage vascular stent, the vascular stent includes two stent segments with different expansion calibers, the The number of steps formed by the expansion of the stent segments is two steps, and the adjacent stent segments are connected through transition areas, and the transition areas are connected by M-shaped connecting ribs 26 .
实施例三：图3所示为本实用新型所述阶梯形球囊扩张式血管支架的一种实施方式，本实施例所述血管支架为三阶式血管支架，所述血管支架包括三个不同扩张口径的支架段，所述支架段经梯形球囊扩张膨胀后所形成的阶梯数为三阶，相邻的所述支架段通过过渡区连接，所述过渡区采用S型连接筋25连接，连接相邻所述支架段的S型连接筋25的连接方向与所述血管支架轴向一致。Embodiment 3: Figure 3 shows an embodiment of the stepped balloon-expandable vascular stent of the present invention. The vascular stent described in this embodiment is a three-stage vascular stent, and the vascular stent includes three different The stent section with an expanded caliber, the number of steps formed after the stent section is expanded by the trapezoidal balloon is three steps, and the adjacent stent sections are connected by a transition zone, and the transition zone is connected by an S-shaped connecting rib 25, The connecting direction of the S-shaped connecting ribs 25 connecting adjacent stent segments is consistent with the axial direction of the vascular stent.
所述实施例为本实用新型的优选的实施方式，但本实用新型并不限于上述实施方式，在不背离本实用新型的实质内容的情况下，本领域技术人员能够做出的任何显而易见的改进、替换或变型均属于本实用新型的保护范围。Described embodiment is the preferred embodiment of the present utility model, but the present utility model is not limited to above-mentioned embodiment, under the situation of not departing from the essential content of the present utility model, any obvious improvement that those skilled in the art can make , replacement or modification all belong to the protection scope of the present utility model.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201520839069.3UCN205251768U (en) | 2015-10-27 | 2015-10-27 | Stairstepping sacculus expanding blood vessel support |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201520839069.3UCN205251768U (en) | 2015-10-27 | 2015-10-27 | Stairstepping sacculus expanding blood vessel support |
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| CN205251768Utrue CN205251768U (en) | 2016-05-25 |
| Application Number | Title | Priority Date | Filing Date |
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| CN201520839069.3UExpired - Fee RelatedCN205251768U (en) | 2015-10-27 | 2015-10-27 | Stairstepping sacculus expanding blood vessel support |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105250059A (en)* | 2015-10-27 | 2016-01-20 | 江苏大学 | Stepped balloon dilatation vascular stent |
| TWI615135B (en)* | 2016-11-30 | 2018-02-21 | 財團法人金屬工業研究發展中心 | Intravascular stent |
| CN113069256A (en)* | 2021-03-26 | 2021-07-06 | 珠海通桥医疗科技有限公司 | Intracranial flexible closed loop stent |
| CN113208789A (en)* | 2021-03-30 | 2021-08-06 | 北京航空航天大学 | Vascular stent graft |
| CN113545898A (en)* | 2021-08-31 | 2021-10-26 | 西北有色金属研究院 | Vascular stent structure with uniform stress |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105250059A (en)* | 2015-10-27 | 2016-01-20 | 江苏大学 | Stepped balloon dilatation vascular stent |
| TWI615135B (en)* | 2016-11-30 | 2018-02-21 | 財團法人金屬工業研究發展中心 | Intravascular stent |
| CN113069256A (en)* | 2021-03-26 | 2021-07-06 | 珠海通桥医疗科技有限公司 | Intracranial flexible closed loop stent |
| CN113208789A (en)* | 2021-03-30 | 2021-08-06 | 北京航空航天大学 | Vascular stent graft |
| CN113208789B (en)* | 2021-03-30 | 2022-01-21 | 北京航空航天大学 | Vascular stent graft |
| CN113545898A (en)* | 2021-08-31 | 2021-10-26 | 西北有色金属研究院 | Vascular stent structure with uniform stress |
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