CN115919504B - Split type single embedded branch tectorial membrane support - Google Patents
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Abstract
本申请涉及一种分体式单内嵌分支覆膜支架,其包括设有至少一开窗结构的主体支架;内嵌支架的一端密封固定于开窗结构,以使开窗结构通过内嵌支架与主体支架的连通腔连通;分支支架通过开窗结构可拆卸插接于内嵌支架内;分支支架包括分支覆膜以及固定于分支覆膜的分支骨架组件,沿分支支架的径向,分支覆膜包括第一层膜和第二层膜,第一层膜位于分支支架的连接腔的内侧,第二层膜位于分支支架的外侧,分支骨架组件固定于第一层膜和第二层膜之间,分支覆膜的近端和远端分别一体成形有翻折段,翻折段固定于分支覆膜的内周壁。本申请具有减少心动周期内分支支架对LSA远端血管壁的损伤刺激,提高分支动脉远期通畅率的效果。
The present application relates to a split-type single embedded branch covered stent, which includes a main frame with at least one fenestration structure; one end of the embedded stent is sealed and fixed to the fenestration structure, so that the fenestration structure passes through the embedded stent and the fenestration structure. The connecting cavity of the main stent is connected; the branch stent is detachably inserted into the embedded stent through the fenestration structure; the branch stent includes the branch film and the branch skeleton assembly fixed on the branch film. Along the radial direction of the branch stent, the branch film Including a first layer of membrane and a second layer of membrane, the first layer of membrane is located inside the connecting cavity of the branch stent, the second layer of membrane is located outside the branch stent, and the branch skeleton assembly is fixed between the first layer of membrane and the second layer of membrane , the proximal end and the far end of the branch coating are respectively integrally formed with folded sections, and the folded sections are fixed to the inner peripheral wall of the branch coating. The application has the effect of reducing the damage and stimulation of the branch stent to the LSA distal vessel wall in the cardiac cycle, and improving the long-term patency rate of the branch artery.
Description
技术领域technical field
本申请涉及医疗器械的领域,尤其是涉及一种分体式单内嵌分支覆膜支架。The present application relates to the field of medical devices, in particular to a split-type single-embedded branch covered stent.
背景技术Background technique
随着腔内技术的提高及材料科学的进步,腔内修复术(Thoracic EndovascularAortic Artery Repair, TEVAR)已经成为B型主动脉夹层的首选治疗方式,但对于破口或血肿靠近分支动脉(例如左锁骨动脉(LeftSubclavian Artery, LSA))的病变由于近端锚定区不足或不健康,常规TEVAR需封堵左锁骨动脉以延长近端锚定区,但术后可能出现左上肢缺血、锁骨下动脉窃血综合征、椎动脉型脑缺血等并发症,并增加截瘫的风险,因此在进行TEVAR 手术治疗Stanford B型夹层时,保留或重建左锁骨动脉非常重要。With the improvement of endovascular technology and advances in material science, Thoracic Endovascular Aortic Artery Repair (TEVAR) has become the first choice for the treatment of type B aortic dissection. Artery (Left Subclavian Artery, LSA)) lesions due to insufficient or unhealthy proximal anchoring area, conventional TEVAR needs to occlude the left clavicle artery to prolong the proximal anchoring area, but left upper limb ischemia, subclavian artery stealing may occur after surgery Therefore, it is very important to preserve or reconstruct the left clavicle artery when performing TEVAR surgery for Stanford type B dissection.
左锁骨动脉重建的常用手术方式有杂交手术、平行支架技术、开窗技术和分支支架技术等。杂交手术效果确切,但相比全腔内手术仍有创伤大、手术时间长的缺点。平行支架技术相对简单易于操作,但由于两个支架间存在沟槽(gutter),使得I型内漏出现的几率增高,另外支架间和支架与主动脉壁间的相互作用力使得逆撕夹层和平行支架闭塞的风险增高。开窗技术主要是在支架的人工血管膜上预留、术前根据具体情况设计侧孔或者原位开窗,支架释放后通过侧孔保留分支动脉血供,缺点是定位不准确,技术难度高,存在失败的风险,改造支架过程中有增加感染的几率,或者有影响LSA支架远期通畅率、主体支架结构稳定和/或使用寿命的风险。分支支架技术更加符合生理解剖,在降低I型内漏风险的同时也降低了III型内漏风险,对破口位于LSA的病变也能有效隔绝,未来有望成为重建LSA的首选方式。Common surgical methods for left clavicle artery reconstruction include hybrid surgery, parallel stent technique, fenestration technique, and branch stent technique. Hybrid surgery is effective, but compared with total endovascular surgery, it still has the disadvantages of large trauma and long operation time. Parallel stent technology is relatively simple and easy to operate, but because there is a gutter between the two stents, the probability of type I endoleak increases, and the interaction force between the stents and between the stent and the aortic wall makes reverse tearing of the dissection and There is an increased risk of parallel stent occlusion. The fenestration technique is mainly to reserve on the artificial vascular membrane of the stent, design a side hole or in-situ fenestration according to the specific situation before the operation, and reserve the blood supply of the branch arteries through the side hole after the stent is released. The disadvantage is that the positioning is not accurate and the technical difficulty is high. , there is a risk of failure, an increase in the chance of infection during the reconstruction of the stent, or a risk of affecting the long-term patency rate of the LSA stent, the structural stability of the main stent and/or the service life. The branch stent technology is more in line with the physiological anatomy. While reducing the risk of type I endoleak, it also reduces the risk of type III endoleak. It can also effectively isolate lesions with breaches located in LSA. It is expected to become the first choice for reconstructing LSA in the future.
分支支架技术中提供了一种一体化分支型主动脉覆膜支架的技术以治疗Stanford B型夹层患者,其利用相应的介入器械将覆膜支架径向压缩后输送至病变位置后释放出来,以使覆膜支架回复至预定形态,从而将人体血管的夹层破口或扩大的腔体隔开来,重塑血管真腔,使血流恢复正确的流向,进而达到治疗效果。为了保证分支动脉的血供,通常通过分支支架连接分支动脉和覆膜支架,即,将分支支架和覆膜支架一体设置,并将分支支架释放于分支动脉内,从而起到保证分支动脉血供的效果。然而,分支支架在拉入分支动脉内时会对动脉内壁造成损伤。Branch stent technology provides an integrated branched aortic stent-graft technology to treat patients with Stanford type B dissection. It uses corresponding interventional instruments to radially compress the stent-graft and deliver it to the lesion position to release it. Restore the stent graft to the predetermined shape, thereby separating the dissection breach or enlarged cavity of the human blood vessel, reshaping the true lumen of the blood vessel, and restoring the blood flow to the correct direction, thereby achieving the therapeutic effect. In order to ensure the blood supply of the branch arteries, the branch arteries and the stent graft are usually connected by a branch stent, that is, the branch stent and the stent graft are integrated, and the branch stent is released in the branch artery, thereby ensuring the blood supply of the branch artery. Effect. However, branch stents can cause damage to the inner wall of the artery when pulled into the branch artery.
发明内容Contents of the invention
为了改善现有的覆膜支架的分支支架在拉入分支动脉内时会对动脉内壁造成损失的问题,本申请提供一种分体式单内嵌分支覆膜支架。In order to improve the problem that the branch stent of the existing covered stent will cause damage to the inner wall of the artery when it is pulled into the branch artery, the present application provides a split-type single-embedded branch covered stent.
本申请提供一种分体式单内嵌分支覆膜支架,包括主体支架,所述主体支架为两端开口的管状结构,所述主体支架围合成用于和目标血管连通的连通腔,所述主体支架设有至少一开窗结构;The application provides a split-type single embedded branch covered stent, including a main body stent, the main body stent is a tubular structure with openings at both ends, the main body stent encloses a communication cavity for communicating with the target blood vessel, the main body The bracket is provided with at least one window structure;
内嵌支架,所述内嵌支架为两端开口的管状结构,所述内嵌支架的一端密封固定于所述开窗结构,以使所述开窗结构通过所述内嵌支架与所述主体支架的所述连通腔连通;及An embedded bracket, the embedded bracket is a tubular structure with openings at both ends, and one end of the embedded bracket is sealed and fixed to the window structure, so that the window structure passes through the embedded bracket and the main body The communication cavity of the stent communicates; and
分支支架,所述分支支架为两端开口的管状结构,所述分支支架围合成用于和分支动脉连通的连接腔,所述分支支架通过所述开窗结构可拆卸插接于所述内嵌支架内,以使所述分支支架的所述连接腔与所述连通腔连通;A branch stent, the branch stent is a tubular structure with openings at both ends, the branch stent encloses a connecting cavity for communicating with the branch artery, and the branch stent is detachably plugged into the embedded In the stent, the connection cavity of the branch stent communicates with the communication cavity;
所述分支支架包括分支覆膜以及固定于所述分支覆膜的分支骨架组件,沿所述分支支架的径向,所述分支覆膜包括第一层膜和第二层膜,所述第一层膜位于所述分支支架的所述连接腔的内侧,所述第二层膜位于所述分支支架的外侧,所述分支骨架组件固定于所述第一层膜和所述第二层膜之间,所述分支覆膜的近端和远端分别一体成形有翻折段,所述翻折段固定于所述分支覆膜的内周壁。The branch stent includes a branch film and a branch skeleton assembly fixed to the branch film. Along the radial direction of the branch stent, the branch film includes a first layer of film and a second layer of film. The first A layer of membrane is located inside the connecting cavity of the branch stent, the second layer of membrane is located outside the branch stent, and the branch skeleton assembly is fixed between the first layer of membrane and the second layer of membrane In between, the proximal end and the distal end of the branch coating are respectively integrally formed with folded sections, and the folded sections are fixed to the inner peripheral wall of the branch coating.
在其他一些实施方式中,所述主体支架包括管状覆膜、裸支架及多个支撑骨架,所述裸支架和所述支撑骨架均呈环状结构,所述裸支架固定于所述管状覆膜的近端,多个所述支撑骨架位于所述裸支架的远端侧,多个所述支撑骨架沿所述管状覆膜的轴向依次排列固定;所述裸支架和所述支撑骨架均包括多个呈夹角依次相连的支撑杆,沿所述主体支架的周向上,相邻的两个所述夹角分别为波峰和波谷,所述波峰相比所述波谷更靠近所述主体支架的近端;至少部分所述支撑骨架的所述波峰、所述波谷和所述支撑杆均贴合固定于所述管状覆膜的周壁,至少部分所述支撑骨架的至少部分所述波峰与所述管状覆膜之间具有间隙且能够和所述管状覆膜分离从而形成自由区,所述自由区的轴向长度至少为2.5-4mm。In some other embodiments, the main body stent includes a tubular membrane, a bare stent, and a plurality of supporting skeletons, both the bare stent and the supporting framework are in a ring structure, and the bare stent is fixed on the tubular membrane A plurality of the support skeletons are located at the distal end side of the bare stent, and a plurality of the support skeletons are arranged and fixed in sequence along the axial direction of the tubular covering; the bare stent and the support skeleton both include A plurality of supporting rods connected successively at included angles, along the circumferential direction of the main body bracket, two adjacent included angles are respectively crests and troughs, and the crests are closer to the center of the main body bracket than the troughs Proximal end: at least part of the crests, troughs and the support rods of the supporting frame are fitted and fixed on the peripheral wall of the tubular covering, at least part of the crests of the supporting frame are in contact with the The tubular coverings have gaps therebetween and are separable from said tubular coverings to form free zones, said free zones having an axial length of at least 2.5-4 mm.
在其他一些实施方式中,多个所述支撑骨架包括沿所述管状覆膜的近端至远端依次排列的贴壁骨架、束径骨架、辅助骨架及远端骨架,所述贴壁骨架和所述束径骨架均位于所述开窗结构的近端侧,所述辅助骨架及所述远端骨架均位于所述开窗结构的远端侧;所述裸支架的所述波谷固定于所述管状覆膜,所述裸支架的所述波峰和所述裸支架的所述支撑杆至少局部延伸出所述管状覆膜的近端;所述贴壁骨架上的各支撑杆的轴向长度均相同;所述束径骨架设有多个,至少一所述束径骨架上的各支撑杆的轴向长度均相同;所述远端骨架上的各支撑杆的轴向长度均相同;In some other embodiments, the plurality of supporting skeletons include an adherent skeleton, a bundle diameter skeleton, an auxiliary skeleton and a distal skeleton arranged in sequence from the proximal end to the distal end of the tubular membrane, and the adherent skeleton and The beam diameter skeletons are all located on the proximal side of the fenestration structure, the auxiliary skeleton and the distal skeleton are both located on the distal side of the fenestration structure; the troughs of the bare stent are fixed on the The tubular covering, the crest of the bare stent and the struts of the bare stent at least partially extend beyond the proximal end of the tubular covering; the axial length of each strut on the adherent skeleton are all the same; there are multiple beam diameter skeletons, and the axial lengths of the supporting rods on at least one of the beam diameter skeletons are the same; the axial lengths of the supporting rods on the distal end skeleton are the same;
所述辅助骨架设置有至少两个,相邻两个所述辅助骨架的所述波谷在轴向上相对,相邻两个所述辅助骨架的所述波峰在轴向上相对;沿所述主体支架的周向上,所述辅助骨架上相邻的两个所述波峰中包括高波和低波,所述高波相比所述低波更靠近所述主体支架的近端;所述辅助骨架上的所述波峰中,所述高波和所述低波沿所述主体支架的周向交替设置。There are at least two auxiliary frames, the troughs of two adjacent auxiliary frames are axially opposite, and the peaks of two adjacent auxiliary frames are axially opposite; along the main body In the circumferential direction of the bracket, the two adjacent peaks on the auxiliary frame include high waves and low waves, and the high waves are closer to the proximal end of the main body bracket than the low waves; Among the peaks, the high waves and the low waves are arranged alternately along the circumferential direction of the main body bracket.
在其他一些实施方式中,所述裸支架的所述波谷通过缝合线加密缝合固定有多个缝合线圈以将所述裸支架的所述波谷固定于所述管状覆膜,所述支撑杆通过缝合线缝合固定有至少一个缝合线圈以将所述裸支架的所述支撑杆固定于所述管状覆膜,且所述裸支架的所述支撑杆上的所述缝合线圈与所述裸支架的所述波谷上的所述缝合线圈紧密相邻;所述裸支架的所述波谷和所述支撑杆通过所述缝合线圈固定于所述管状覆膜的轴向长度形成锚定区,所述锚定区的轴向长度至少为3-5mm,所述锚定区的轴向长度为所述裸支架与所述贴壁骨架在轴向上的重合长度。In some other embodiments, the trough of the bare stent is fixed with a plurality of suture loops by dense sutures to fix the trough of the bare stent to the tubular graft, and the support rod is fixed by suturing. At least one suture coil is fixed by thread suture to fix the support rod of the bare stent to the tubular graft, and the suture coil on the support rod of the bare stent is connected to the The suture coils on the troughs are closely adjacent; the troughs of the bare stent and the struts are fixed to the axial length of the tubular graft by the suture coils to form an anchoring zone, and the anchoring The axial length of the region is at least 3-5 mm, and the axial length of the anchoring region is the overlapping length of the bare stent and the adherent framework in the axial direction.
在其他一些实施方式中,多个所述支撑骨架还包括至少一第一加强骨架,至少一所述第一加强骨架位于所述开窗结构的远端侧;所述束径骨架还包括至少一第二加强骨架,至少一所述第二加强骨架位于至少一所述第二全固定骨架的远端侧,所述第一加强骨架和所述第二加强骨架在轴向上相邻设置,所述第一加强骨架和所述第二加强骨架分别位于所述开窗结构轴向上的两侧;至少一所述第一加强骨架上的所述支撑杆的轴向长度相同,至少一所述第二加强骨架上的所述支撑杆的轴向长度相同,至少一所述第一加强骨架上的所述波峰、所述波谷和所述支撑杆均贴合固定于所述管状覆膜的周壁,所述第一加强骨架上的所述波谷和所述第二加强骨架上的所述波峰在轴向上相对。In some other embodiments, the plurality of supporting frames further include at least one first reinforcing frame, and at least one of the first reinforcing frames is located at the distal side of the fenestration structure; the beam diameter frame also includes at least one The second reinforcing frame, at least one second reinforcing frame is located on the distal side of at least one second full fixed frame, the first reinforcing frame and the second reinforcing frame are arranged adjacent to each other in the axial direction, so The first reinforcing frame and the second reinforcing frame are respectively located on both sides of the window structure in the axial direction; at least one of the supporting rods on the first reinforcing frame has the same axial length, and at least one of the The axial lengths of the supporting rods on the second reinforcing frame are the same, and the peaks, the troughs and the supporting rods on at least one of the first reinforcing frames are all attached and fixed to the peripheral wall of the tubular coating , the trough on the first reinforcing skeleton is axially opposite to the crest on the second reinforcing skeleton.
在其他一些实施方式中,所述柔性束径构件为一环状结构,所述束径构件的环上任意至少两点固定于所述主体支架以形成两个固定位点,进而使所述柔性束径构件形成至少两个柔性环;或者,所述柔性束径构件包括至少两个柔性环,所述柔性环长度方向的一端固定于所述管状覆膜和所述支撑骨架的至少一者以形成固定位点;In some other embodiments, the flexible beam diameter member is a ring structure, and any at least two points on the ring of the beam diameter member are fixed to the main body bracket to form two fixing points, so that the flexible The bundle diameter member forms at least two flexible rings; alternatively, the flexible bundle diameter member includes at least two flexible rings, and one end of the flexible ring in the length direction is fixed to at least one of the tubular membrane and the supporting frame to Form a fixed site;
沿所述主体支架的周向,两个所述柔性环远离所述固定位点的一端能够相互重合以形成供束径导丝穿设的线环,所述柔性环的长度方向能够沿所述主体支架的周向排布,至少两个所述柔性环的长度方向能够围抱所述主体支架的周向以使所述主体支架能够径向压缩。Along the circumferential direction of the main body bracket, the ends of the two flexible rings away from the fixing point can overlap each other to form a wire loop for the bundle diameter guide wire to pass through, and the length direction of the flexible ring can be along the The circumferential arrangement of the main body bracket, the length direction of at least two flexible rings can surround the circumferential direction of the main body bracket so that the main body bracket can be radially compressed.
在其他一些实施方式中,所述固定位为固定套,所述固定套将所述连接骨固定于每一所述第一波形环对应的所述分支杆上;或者,所述至少部分固定位由每一所述第一波形环上所述连接骨所在的所述分支杆螺旋缠绕于所述连接骨而形成。In some other embodiments, the fixing position is a fixing sleeve, and the fixing sleeve fixes the connecting bone on the branch rod corresponding to each of the first wave-shaped rings; or, the at least part of the fixing position Each of the first wave-shaped rings is formed by helically winding the branch rod where the connecting bone is located on the connecting bone.
本申请提供的分体式单内嵌分支覆膜支架,分支支架通过开窗结构插接于内嵌支架内,以使分支支架与连通腔连通,从而将流经连通腔内的血流引入分支支架,重建分支动脉,分支支架与主体支架的可拆卸插接配合,能够减少心动周期内分支支架对 LSA 远端血管壁的损伤刺激,进而保证分支动脉远期通畅率。分支支架的结构设计对分支动脉的远期通畅率有重大影响,分支覆膜为两层膜状物,且分支骨架组件位于两层膜状物之间,进一步能够减少心动周期内分支支架对 LSA 远端血管壁的损伤刺激。分支支架径向压缩于介入器械的过程中,或者分支支架在脱离介入器械以释放于分支动脉的过程中,分支支架与介入器械之间的摩擦力、目标血管和分支动脉自身的脉动、不恰当地主体支架和分支支架释放、定位,都对两层膜状物有不同程度的分离考验,即,两层膜状物具有至少部分彼此分离的风险,导致分支支架具有闭塞的风险,影响分支支架的远期通畅率。至少两段翻折段的设置,有利于改善第一层膜和第二层膜的近端和远端受到高流量血流的冲击、分支支架压缩和释放过程中与介入器械之间的摩擦力、目标血管与分支动脉自身的脉动对分支支架的冲击离或者不恰当的操作而至少部分分离的问题,降低分支支架发生闭塞的风险,提高分支支架的远期通畅率。In the split-type single embedded branch covered stent provided by the present application, the branched stent is inserted into the embedded stent through the fenestrated structure, so that the branched stent communicates with the communicating cavity, so that the blood flow flowing through the communicating cavity is introduced into the branched stent , to reconstruct branch arteries, the detachable plug-in cooperation between the branch stent and the main body stent can reduce the damage and stimulation of the branch stent to the LSA distal vessel wall during the cardiac cycle, thereby ensuring the long-term patency of the branch artery. The structural design of the branch stent has a significant impact on the long-term patency of the branch artery. The covering of the branch is two layers of membrane, and the branch skeleton component is located between the two layers of membrane, which can further reduce the impact of the branch stent on the LSA during the cardiac cycle. Injury stimulation of the distal vessel wall. During the process of radial compression of the branch stent in the interventional device, or in the process of releasing the branch stent from the interventional device to the branch artery, the friction between the branch stent and the interventional device, the pulsation of the target vessel and the branch artery itself, inappropriate The release and positioning of the main body stent and the branch stent have different degrees of separation tests on the two layers of membranous material, that is, the two layers of membranous material have the risk of being at least partially separated from each other, resulting in the risk of occlusion of the branch stent and affecting the branch stent. long-term patency. The setting of at least two turning sections is beneficial to improve the friction force between the proximal end and the distal end of the first layer of film and the second layer of film being impacted by high-flow blood flow, and the friction between the branch stent and the interventional instrument during the compression and
附图说明Description of drawings
图1为分体式单内嵌分支覆膜支架的结构示意图。Fig. 1 is a schematic diagram of the structure of a split type single embedded branch covered stent.
图2为分体式单内嵌分支覆膜支架的另一视角的结构示意图。Fig. 2 is a structural schematic diagram of another viewing angle of the split-type single embedded branch stent-graft.
图3为主体支架的结构示意图(未示出柔性束径构件)。Fig. 3 is a schematic structural view of the main body stent (the flexible bundle diameter member is not shown).
图4为主体支架的平面展开图(未示出内嵌支架)。Fig. 4 is a plane expanded view of the main body bracket (the built-in bracket is not shown).
图5为主体支架另一可能实施方式的平面展开图。Fig. 5 is a plan development view of another possible embodiment of the main body bracket.
图6为柔性束径构件与外接束径导丝配合以径向压缩部分主体支架的结构示意图。Fig. 6 is a structural schematic diagram of the cooperation of the flexible bundle diameter member and the circumscribed bundle diameter guide wire to radially compress part of the main body stent.
图7为内嵌支架的结构示意图。Fig. 7 is a schematic diagram of the structure of the embedded stent.
图8为分支支架的结构示意图。Fig. 8 is a schematic structural diagram of a branch bracket.
图9为连接骨与第一波形环的另一可能固定方式的结构示意图。Fig. 9 is a structural schematic diagram of another possible fixing method for connecting the bone and the first wave-shaped ring.
图10为分体式单内嵌分支覆膜支架用于重建主动脉弓的场景示意图。Fig. 10 is a schematic diagram of a scene where a split type single embedded branch covered stent is used for reconstruction of the aortic arch.
图11为主体支架另一示例性结构示意图。Fig. 11 is a schematic diagram of another exemplary structure of the main body bracket.
图12为图11中A处的放大结构示意图。FIG. 12 is a schematic diagram of an enlarged structure at point A in FIG. 11 .
附图标记说明:1、主体支架;10、管状覆膜;20、裸支架;201、锚定区;30、支撑骨架;3001、支撑杆;3002、波峰;3003、波谷;31、贴壁骨架;32、束径骨架;321、第一全固定骨架;322、第二全固定骨架;3221、高波;3222、低波;323、第二加强骨架;33、第一加强骨架;34、辅助骨架;341、自由区;35、远端骨架;36、加强部;361、第一支撑杆;362、第二支撑杆;363、加强波谷;364、第一贴壁波谷;365、第二贴壁波谷;366、第一避位波峰;367、第二避位波峰;40、柔性束径构件;401、柔性环;402、固定位点;403、线环;404、束径导丝;50、缝合线圈;60、连接结点;70、显影标记;2、内嵌支架;21、内嵌覆膜;22、内嵌骨架;3、分支支架;301、分支覆膜;302、支撑段;303、柔性段;304、贴壁段;305、翻折段;306、支撑骨环;3061、第一波形环;3062、第二波形环;3063、连接骨;3064、分支杆;3065、固定套;307、柔性骨环;371、波形单元;372、单元杆;308、贴壁骨环;4、开窗结构;5、主动脉弓;6、小弯侧;7、左锁骨动脉;8、瘤腔。Explanation of reference numerals: 1. main body support; 10. tubular coating; 20. bare support; 201. anchoring area; 30. support frame; 3001. support rod; 3002. peak; ;32, beam diameter frame; 321, first fully fixed frame; 322, second fully fixed frame; 3221, high wave; 3222, low wave; 323, second reinforced frame; 33, first reinforced frame; 34, auxiliary frame ; 341, free zone; 35, distal skeleton; 36, reinforced part; 361, first support rod; 362, second support rod; 363, reinforced trough; 364, first wall-attached trough; 365, second wall-attached trough; 366, first avoidance peak; 367, second avoidance peak; 40, flexible beam diameter member; 401, flexible ring; 402, fixed position; 403, wire ring; 404, beam diameter guide wire; 50, Suture coil; 60, connecting node; 70, developing mark; 2, embedded stent; 21, embedded membrane; 22, embedded skeleton; 3, branch bracket; 301, branch membrane; 302, support section; 303 , flexible segment; 304, adherent segment; 305, folded segment; 306, supporting bone ring; 3061, first wave ring; 3062, second wave ring; 3063, connecting bone; 3064, branch rod; 3065, fixed sleeve ;307, flexible bone ring; 371, wave-shaped unit; 372, unit rod; 308, adherent bone ring; 4, fenestration structure; 5, aortic arch; 6, lesser curvature; 7, left clavicle artery; 8, tumor cavity .
具体实施方式Detailed ways
下面将结合本申请实施方式中的附图,对本申请实施方式中的技术方案进行清楚、完整地描述,显然,所描述的实施方式仅仅是本申请一部分实施方式,而不是全部的实施方式。基于本申请中的实施方式,本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施方式,都属于本申请保护的范围。The following will clearly and completely describe the technical solutions in the embodiments of the application with reference to the accompanying drawings in the embodiments of the application. Apparently, the described embodiments are only part of the embodiments of the application, not all of them. Based on the implementation manners in this application, all other implementation manners obtained by persons of ordinary skill in the art without creative efforts shall fall within the scope of protection of this application.
对于介入医疗器械领域,近端是指将支架用于介入治疗后其靠近人体心脏的一端,远端是指支架用于介入治疗后其远离人体心脏的一端。将柱体、管体等一类物体的旋转中心轴的方向为轴向,与轴向垂直的方向为径向。周向就是指“圆周方向”,即绕柱体、管体等轴线方向(垂直于轴线,同时垂直于截面半径)。“周向”、“轴向”、“径向”共同构成柱坐标的三个正交方向。周向长度,是指结构或元件沿柱体、管体等的周向方向的延伸长度。轴向长度,是指结构或元件沿柱体、管体等的轴向方向的延伸长度。该种描述只是为了表述方便,并不构成对本申请的限制。以下的结构是指分体式单内嵌分支覆膜支架膨胀后的结构。For the field of interventional medical devices, the proximal end refers to the end of the stent close to the human heart after the interventional treatment, and the distal end refers to the end of the stent away from the human heart after the interventional treatment. The direction of the rotation center axis of objects such as cylinders and tubes is the axial direction, and the direction perpendicular to the axial direction is the radial direction. The circumferential direction refers to the "circumferential direction", that is, the direction around the axis of the cylinder, tube, etc. (perpendicular to the axis and perpendicular to the radius of the section). "Circumferential", "axial", and "radial" together constitute three orthogonal directions of cylindrical coordinates. Circumferential length refers to the extension length of a structure or element along the circumferential direction of a column, tube, etc. Axial length refers to the extension length of a structure or element along the axial direction of a column, tube, etc. This description is only for the convenience of expression, and does not constitute a limitation to the present application. The structure below refers to the expanded structure of the split-type single-embedded branch stent-graft.
为了改善现有的覆膜支架的分支支架在拉入分支动脉内时会对动脉内壁造成损失的问题,本申请第一实施例提供一种分体式单内嵌分支覆膜支架,可应用于血管中以实施腔内隔绝术来隔绝管腔内的病变区域或隔绝夹层破口,例如,可采用分体式单内嵌分支覆膜支架在血管的管腔中隔绝动脉夹层破口或动脉瘤等。可以理解,该血管可以是主动脉弓、胸主动脉,或腹主动脉等。本领域的普通技术人员应当知晓,采用血管来阐述仅用作举例,并不是对本申请的限制,本申请的方案适用于各种人体或动物管腔,例如消化道管腔等。In order to improve the problem that the branch stent of the existing stent-graft will cause damage to the inner wall of the artery when it is pulled into the branch artery, the first embodiment of the present application provides a split-type single-embedded branch stent-graft, which can be applied to blood vessels In this method, endoluminal isolation can be performed to isolate the lesion area in the lumen or the dissection breach. For example, a split-type single-embedded branch covered stent can be used to isolate the arterial dissection breach or aneurysm in the lumen of the blood vessel. It can be understood that the blood vessel may be the aortic arch, thoracic aorta, abdominal aorta, etc. Those of ordinary skill in the art should know that the use of blood vessels for illustration is only used as an example and not a limitation of the present application. The solutions of the present application are applicable to various human or animal lumens, such as digestive tract lumens.
请参阅图1及图2,图1为分体式单内嵌分支覆膜支架的结构示意图,图2为分体式单内嵌分支覆膜支架的另一视角的结构示意图。分体式单内嵌分支覆膜支架包括主体支架1、固定于主体支架1内壁的内嵌支架2及可拆卸连接于主体支架1的分支支架3,分支支架3用于重建分支动脉。主体支架1为两端开口的管状结构,主体支架1围合成用于和目标血管连通的连通腔(图中未示出)。主体支架1设有至少一开窗结构4,开窗结构4可以是圆形、椭圆形或其他不规则形状等。内嵌支架2为两端开口的管状结构,内嵌支架2的一端密封固定于开窗结构4,以使开窗结构4通过内嵌支架2与主体支架1的连通腔连通。分支支架3为两端开口的管状结构,分支支架3围合成用于和分支动脉连通的连接腔(图中未示出)。分支支架3通过开窗结构4插接于内嵌支架2内,以使分支支架3与连通腔连通,从而将流经连通腔内的血流引入分支支架3,重建分支动脉。分支支架3与主体支架1的可拆卸插接配合,能够减少心动周期内分支支架3对 LSA 远端血管壁的损伤刺激,进而保证分支动脉远期通畅率。Please refer to FIG. 1 and FIG. 2 . FIG. 1 is a schematic structural diagram of a split-type single embedded branch stent-graft, and FIG. 2 is a structural schematic diagram of a split-type single embedded branch stent-graft from another perspective. The split-type single embedded branch stent-graft includes a
请结合参阅图3及图4,图3为主体支架1的结构示意图(未示出柔性束径构件40),图4为主体支架1的平面展开图(未示出内嵌支架2)。主体支架1包括管状覆膜10、裸支架20、多个支撑骨架30及多组柔性束径构件40。裸支架20和支撑骨架30均呈环状结构,裸支架20固定于管状覆膜10的近端,多个支撑骨架30位于裸支架20的远端侧,多个支撑骨架30沿管状覆膜10的轴向依次排列固定。裸支架20和支撑骨架30均包括多个呈夹角依次相连的支撑杆3001,沿主体支架1的周向上,相邻的两个夹角分别为波峰3002和波谷3003,波峰3002相比波谷3003更靠近主体支架1的近端。裸支架20和支撑骨架30可以通过缝合、贴覆、冲压、贴设、镶设或热压等方式固定于管状覆膜10上。多组柔性束径构件40均位于开窗结构4的近端侧,柔性束径构件40用于径向压缩位于开窗结构4近端侧的局部主体支架1,即,开窗结构4的近端边缘至主体支架1近端边缘的区域能够被柔性束径构件40径向压缩以处于径向压缩状态,使得主体支架1进入目标血管后,至少部分径向压缩的主体支架1依然能够在目标血管内轴向移动或周向转动,从而便于精确调整开窗结构4的位置,使得开窗结构4更好地和分支动脉的根部开口对中,提高开窗结构4的定位精度。Please refer to FIG. 3 and FIG. 4 together. FIG. 3 is a schematic structural view of the main body stent 1 (the flexible
多个支撑骨架30包括贴壁骨架31、束径骨架32、至少一第一加强骨架33、辅助骨架34及远端骨架35,贴壁骨架31、束径骨架32、至少一第一加强骨架33、辅助骨架34及远端骨架35沿管状覆膜10的近端至管状覆膜10的远端依次排列固定。贴壁骨架31和束径骨架32均位于开窗结构4的近端侧,辅助骨架34、远端骨架35及至少一第一加强骨架33均位于开窗结构4的远端侧。A plurality of supporting
裸支架20的波谷3003固定于管状覆膜10上,裸支架20的波峰3002和裸支架20的支撑杆3001至少局部延伸出管状覆膜10的近端,即裸支架20的支撑杆3001的至少局部及裸支架20的波峰3002未被管状覆膜10覆盖,换而言之,沿支撑杆3001的轴向方向,支撑杆3001至少局部未被管状覆膜10覆盖,且裸支架20的波峰3002未被管状覆膜10覆盖。裸支架20的波谷3003通过缝合线加密缝合固定有多个缝合线圈50以将裸支架20的波谷3003固定于管状覆膜10的近端(即多个缝合线圈50之间紧密相邻),支撑杆3001通过缝合线缝合固定有至少一个缝合线圈50以将裸支架20的支撑杆3001固定于管状覆膜10,且支撑杆3001上的缝合线圈50与裸支架20的波谷3003上的缝合线圈50紧密相邻。裸支架20的波谷3003和支撑杆3001通过缝合线圈50固定于管状覆膜10的轴向长度形成了锚定区201,锚定区201的轴向长度至少为3-5mm,即,裸支架20被管状覆膜10覆盖的轴向长度为3-5mm,且裸支架20被管状覆膜10覆盖的部分通过缝合线圈50固定于管状覆膜10。在其他一些实施方式中,缝合线圈50的示例性形成方式可以是:以支撑骨架30固定于管状覆膜10的外周壁举例说明,将支撑杆3001长度方向的两侧分别命名为第一侧和第二侧,缝合线的一端固定于管状覆膜10的外周壁,步骤S1,将缝合线的另一端沿支撑杆3001的第一侧穿入管状覆膜10的内周壁,步骤S2,紧接着缝合线从管状覆膜10的内周壁沿支撑杆3001的第二侧穿出至管状覆膜10的外周壁,步骤S3,随后缝合线包绕支撑杆3001并从支撑杆3001的第一侧穿入至管状覆膜10的内周壁,步骤S1-步骤S3完成后即形成一大致呈环状结构的缝合线圈50。最后沿支撑骨架30的形状走势重复步骤S1-步骤S3以将裸支架20、支撑骨架30固定于管状覆膜10。The
贴壁骨架31、束径骨架32、至少一第一加强骨架33及远端骨架35的波峰3002、波谷3003和支撑杆3001均通过缝合线缝合固定于管状覆膜10,例如波峰3002和波谷3003均通过缝合线加密缝合固定有多个缝合线圈50(即多个缝合线圈50之间紧密相邻),支撑杆3001间隔设置至少一个缝合线圈50,以使缝合线将贴壁骨架31、束径骨架32、至少一第一加强骨架33及远端骨架35贴合固定于管状覆膜10,进而使得贴壁骨架31、束径骨架32、至少一第一加强骨架33及远端骨架35几乎完全贴合管状覆膜10固定,既提高贴壁骨架31、束径骨架32、至少一第一加强骨架33及远端骨架35的径向支撑力,也有利于避免束径骨架32钩挂到柔性束径构件40,从而有利于柔性束径构件40的解脱以释放主体支架1,使主体支架1自膨胀以顺利恢复至预定形态。The
至少一贴壁骨架31位于开窗结构4的近端侧。贴壁骨架31的波形走势与裸支架20的波形走势保持一致,即,贴壁骨架31的波峰3002与裸支架20的波峰3002在轴向上相对,第一全固定骨架321的波谷3003与裸支架20的波谷3003在轴向上相对,使得贴壁骨架31的波峰3002能够位于裸支架20相邻两个支撑杆3001之间的区域,有利于避免管状覆膜10的近端在植入目标血管后,由于目标血管的解剖结构较为弯曲而导致管状覆膜10近端容易打皱,有利于减少Ia型内漏的发生。将裸支架20上的支撑杆3001与管状覆膜10的近端边缘交叉的点以及贴壁骨架31的波峰3002与管状覆膜10的接触点均命名为连接结点60,裸支架20的锚定区201的轴向长度的设置,使得各连接结点60沿管状覆膜10的周向排布更为合理,避免任意相邻两个连接结点60之间沿周向上的间距相差太大,即锚定区201的轴向长度的设置使得各连接结点60沿管状覆膜10的周向排布更为均匀,有利于进一步避免管状覆膜10的近端植入弯曲的目标血管后发生打皱的问题,从而更好的起到防内漏的效果。贴壁骨架31的波峰3002固定于管状覆膜10靠近近端边缘的位置,使得锚定区201的轴向长度大致为裸支架20与贴壁骨架31在轴向上的重合长度(即贴壁骨架31的波峰3002与管状覆膜10的近端边缘的距离允许有±1.5mm的误差),裸支架20的锚定区201的轴向长度的设置使得主体支架1径向收缩或者径向自膨胀的过程中,贴壁骨架31的波形走势与裸支架20的波形走势保持一致,有利于避免主体支架1近端在径向收缩或径向自膨胀的过程中变形,从而使得主体支架1与血管壁之间的贴壁性更好,进一步提高防内漏的效果。贴壁骨架31中,各支撑杆3001沿管状覆膜10的轴向长度相同,以增强主体支架1近端的径向支撑力,从而有利于减少主体支架1植入目标血管之后由于高流量血流的冲击而发生位移的风险。At least one wall-attached
束径骨架32包括至少一第一全固定骨架321、至少一第二全固定骨架322及至少一第二加强骨架323,至少一第一全固定骨架321、至少一第二全固定骨架322及至少一第二加强骨架323沿管状覆膜10的近端至远端依次排列固定。至少一第一全固定骨架321可以位于开窗结构4的近端侧。至少一第一全固定骨架321位于至少一贴壁骨架31的远端侧,且第一全固定骨架321的波长小于其他支撑骨架30的波长,换而言之,至少一第一全固定骨架321的波形相比其他支撑骨架30的波形更为密集,使得主体支架1的近端更好地贴合血管壁,降低Ia型内漏的风险。至少一第一全固定骨架321上各支撑杆3001沿主体支架1的轴向长度均相同,以进一步增加主体支架1近端有的径向支撑力,从而有利于减少主体支架1植入目标血管之后由于高流量血流的冲击而发生位移的风险。
至少一第二全固定骨架322位于开窗结构4的近端侧。至少一第三固定骨架上的各支撑杆3001的轴向长度不同,具体地,沿主体支架1的周向上,相邻两个波峰3002中包括高波3221和低波3222,高波3221相比低波3222更靠近主体支架1的近端。沿主体支架1的周向上,高波3221和低波3222交替设置,从而有利于降低主体支架1近端的回直力,提高主体支架1近端的柔顺性,使得主体支架1的近端更好的贴合弯曲的血管解剖结构,有利于降低Ia型内漏的发生风险。At least one second
在其他实施方式中,例如请参阅图5,图5为主体支架1另一可能实施方式的平面展开图。也可以省略第二全固定骨架322的设置。In other embodiments, for example, please refer to FIG. 5 , which is a plan development view of another possible embodiment of the
在本实施例中,第一加强骨架33和第二加强骨架323在轴向上相邻设置,第一加强骨架33和第二加强骨架323分别位于开窗结构4轴向上的两侧,即第一加强骨架33位于开窗结构4的远端侧,第二加强骨架323位于开窗结构4的近端侧。第一加强骨架33上的各支撑杆3001的轴向长度均相同,第二加强骨架323上的各支撑杆3001的轴向长度均相同。第一加强骨架33和第二加强骨架323的设置用于增强开窗结构4周围的径向支撑力,使得开窗结构4能够更为充分的和血管壁接触,有利于改善开窗结构4被挤压变形(例如钙化斑块、不规则的血管截面等对主体支架1的挤压)的问题。对于第一加强骨架33和第二加强骨架323上的波峰3002和波谷3003,第一加强骨架33上的波峰3002和第二加强骨架323上的波谷3003在轴向上相对,第一加强骨架33上的波谷3003和第二加强骨架323上的波峰3002在轴向上相对,从而有利于改善主体支架1靠近开窗结构4的部分发生轴向短缩的问题,充分保证开窗结构4从径向压缩状态回复至预定形态,同时,能够为开窗结构4预留更为充足的空间,进一步充分保证开窗结构4从径向压缩状态回复至预定形态。In this embodiment, the first reinforcing
在其他实施方式中,第一加强骨架33上的轴向长度也可以不相同,第二加强骨架323上的轴向长度也可以不相同,即,沿主体支架1的周向上,第一加强骨架33和第二加强骨架323上相邻的两个波峰3002中包括高波3221和低波3222,高波3221相比低波3222更靠近管状覆膜10的近端。沿主体支架1的周向上,高波3221和低波3222交替设置,以进一步提高主体支架1近端的柔顺性,改善鸟嘴征效应。In other embodiments, the axial length of the first reinforcing
根据本申请的示例性实施例,在一些示例性实施例中,也可以省略第二加强骨架323的设置,使得开窗结构4位于至少一第一全固定骨架321和第一加强骨架33之间。According to the exemplary embodiment of the present application, in some exemplary embodiments, the setting of the second reinforcing
辅助骨架34设置有至少两个,至少两个辅助骨架34上的支撑杆3001的轴向长度不相同,即,沿主体支架1的周向上,辅助骨架34上相邻的两个波峰3002中包括高波3221和低波3222,高波3221相比低波3222更靠近管状覆膜10的近端。沿管状覆膜10的周向上,高波3221和低波3222交替设置。靠近管状覆膜10近端的辅助骨架34上的高波3221与靠近管状覆膜10远端的辅助骨架34上的低波3222在轴向上相对,靠近管状覆膜10近端的辅助骨架34上的波谷3003与靠近管状覆膜10远端的辅助骨架34上的波谷3003在轴向上相对,使得至少两个辅助骨架34的波形走势大致相同。The
辅助骨架34的低波3222、波谷3003和支撑杆3001均通过缝合线缝合固定于管状覆膜10,例如低波3222和波谷3003均通过缝合线加密缝合固定有多个缝合线圈50(即多个缝合线圈50之间紧密相邻),支撑杆3001间隔设置至少一个缝合线圈50,以使缝合线将辅助骨架34缝合固定于管状覆膜10。辅助骨架34的高波3221与管状覆膜10之间具有间隙且辅助骨架34的高波3221能够和管状覆膜10分离从而形成自由区341,即,辅助骨架34的高波3221无需通过缝合线固定于管状覆膜10,或者,辅助支架的高波3221无需通过贴覆、冲压、贴设、镶设或热压等方式固定于管状覆膜10,使得辅助骨架34的高波3221相比辅助骨架34的低波3222具有更多的变形空间。自由区341的轴向长度为2.5-4mm,保证辅助骨架34的高波3221具有充足的活动空间。The
主体支架1植入弯曲的目标血管之后,例如主体支架1植入主动脉弓5之后,主体支架1为了适应主动脉弓5拱起的弓部,主体支架1靠近血管小弯侧6(请参阅图10)的一侧需要适应性弯曲,则主体支架1上的支撑骨架30的波峰3002和波谷3003可以在轴向上相互靠近,辅助骨架34上高波3221和低波3222的交替设置以及高波3221的自由区341设置,使得辅助骨架34靠近血管小弯侧6的一侧有更大的变形空间,即,相邻两个辅助骨架34靠近血管小弯侧6一侧的支撑杆3001可以有更多的轴向变形以增加轴向重合长度,同时,高波3221能够向远离主体支架1中轴线的方向与轴向上相邻的支撑骨架30在轴向上折叠,高波3221的自由区341设置带动相邻的波谷3003向靠近主体支架1中轴线的方向与轴向上相邻的支撑骨架30在轴向上折叠,从而使得主体支架1靠近血管小弯侧6的一侧更加贴合血管的弯曲曲线,降低内漏的发生。目标血管的拱起幅度越大,则辅助骨架34靠近血管小弯侧6一侧的支撑杆3001的轴向变形程度越大。After the
远端骨架35设有至少两个,至少两个远端骨架35沿管状覆膜10的轴向依次排列。远端骨架35上各支撑杆3001的轴向长度相同,以增加主体支架1远端的径向支撑力,有利于改善主体支架1植入目标血管后容易发生位移的问题。管状覆膜10的远端设有至少一显影标记70,显影标记70位于靠近管状覆膜10的远端口的至少两个远端骨架35的近端或者近端侧,即,显影标记70可以固定于远端骨架35上,以使显影标记70位于靠近管状覆膜10的远端口的至少两个远端骨架35的近端;显影标记70也可以固定于管状覆膜10上,以使显影标记70位于靠近管状覆膜10的远端口的至少两个远端骨架35的近端侧。显影标记70与管状覆膜10的远端边缘的轴向长度至少为30-50mm。显影标记70用于指示另一外接支架插接于主体支架1的位置,使得外接支架与主体支架1具有充足的重合轴向长度,为外接支架提供充足的锚定长度。管状覆膜10的近端也可以固定有至少一显影标记70以用于指示主体支架1的近端位置;管状覆膜10的远端也可以固定有至少一显影标记70以用于指示主体支架1的远端位置。管状覆膜10上环绕开窗结构4的周向也可以固定有多个显影标记70。在其他一些实施方式中,环绕开窗结构4的周向的显影标记70为四个,其中两个显影标记70位于开窗结构4沿主体支架1轴向上的两侧,另外两个显影标记70位于开窗结构4沿主体支架1周向上的两侧。开窗结构4轴向两侧的两个显影标记70便于开窗结构4最大限度的和分支动脉的根部开口边缘对位,便于手术操作者判断开窗结构4的释放完成度,即便于判断开窗结构4是否释放到最大直径;开窗结构4周向两侧的两个显影标记70便于手术操作者判断在主体支架1释放后两个显影标记70的重合情况,如果开窗结构4周向上的两个显影标记70未重合,手术操作者可以再次调整主体支架1的位置以调整开窗结构4的位置,直至开窗结构4周向上的两个显影标记70重合,从而较好的保证开窗结构4更完全的和分支动脉的根部开口吻合,保证了分支支架3释放的定位精准,明显降低术中操作难度。There are at least two
显影标记70的材料可由不透X射线性能好、耐腐蚀性强、生物相容性好的材料制成,可以是金、铂、钽、锇、铼、钨、铱、铑等材料或这些材料的合金。可以理解,显影标记70也可以理解为对应的远端骨架35或者管状覆膜10的对应位置具有显影材料;或者,可以是管状覆膜10的对应位置设有显影标记70,也可以是对应的远端骨架35或开窗结构4分别设有显影标记70,显影标记70至少环绕部分远端骨架35或开窗结构4设置。The material of the developing
请结合参阅图4和图6,图6为柔性束径构件40与外接束径导丝404配合以径向压缩部分主体支架1的结构示意图。柔性束径构件40为一环状结构,柔性束径构件40的环上任意两点固定于支撑骨架30以形成两个固定位点402(例如通过缝合、贴覆、冲压、贴设、镶设或热压等方式固定于支撑骨架30上以形成固定位点402),从而使柔性束径构件40形成至少两个柔性环401。两个固定位点402可以大致重合,以使柔性环401的长度方向能够沿管状覆膜10的周向方向排布。两个固定位点402也可以不重合,例如两个固定位点402可以在周向间隔一定距离、在轴向上间隔一定距离或者同时在周向和轴向上均间隔有一定距离,能够使得至少部分柔性环401的长度方向沿管状覆膜10的周向方向排布。本实施例中,柔性束径构件40上的至少两个固定位点402可以大致重合以形成重合固定点,多组柔性束径构件40形成的多个重合固定点大致沿主体支架1的轴向方向排列延伸。可以理解,在其他实施方式中,至少两个柔性环401也可以各自独立成形,而不是由同一环状结构通过设置至少两个固定位点402分离得到,例如,柔性束径构件40包括至少两个柔性环401,柔性环401长度方向的一端固定于管状覆膜10和支撑骨架30的至少一者以形成固定位点402。Please refer to FIG. 4 and FIG. 6 in conjunction. FIG. 6 is a structural schematic diagram of the flexible
多组柔性束径构件40从管状覆膜10的近端至远端依次排列,且多组柔性束径构件40均位于开窗结构4的近端侧。对于同一柔性束径构件40,将至少两个柔性环401远离固定位点402的一端沿主体支架1的周向相互靠近,直至至少两个柔性环401远离固定位点402的一端能够相互重合以形成供束径导丝404穿设的线环403,柔性环401的长度方向能够沿主体支架1的周向排布,至少两个柔性环401的长度方向能够围抱主体支架1的周向以使主体支架1能够径向压缩。多组柔性束径构件40形成的多个线环403大致沿主体支架1的轴向方向排列延伸,将一束径导丝404沿主体支架1的轴向依次穿设各个线环403,使得每一柔性束径构件40上的至少两个柔性环401能够形成沿主体支架1的周向围抱主体支架1的环状物,束径导丝404起到维持环状物的作用,从而使得主体支架1的部分轴向长度呈径向压缩状态。主体支架1植入目标血管后,径向压缩的主体支架1依然能够在目标血管内轴向移动或周向转动,从而便于精确调整开窗结构4的位置,使得开窗结构4更好地和分支动脉的根部开口对中,提高开窗结构4的定位精度。Multiple groups of flexible
沿主体支架1的轴向,裸支架20的至少一波谷3003设有柔性束径构件40,贴壁骨架31的至少一波谷3003设有柔性束径构件40,每一束径骨架32上相邻的至少一波谷3003和至少一波峰3002均设有柔性束径构件40。换而言之,沿主体支架1的轴向,多组柔性束径构件40的重合固定点分别位于裸支架20的至少一波谷3003、贴壁骨架31的至少一波谷3003、第一全固定骨架321上相邻的至少一波峰3002和至少一波谷3003、第二全固定骨架322上相邻的至少一高波3221和至少一波谷3003以及第二加强骨架323上相邻的至少一波峰3002和至少一波谷3003。相比将重合固定点设置于支撑杆3001上,将重合固定点设置于支撑骨架30相邻的波峰3002和波谷3003上,有利于改善主体支架1径向压缩装配于介入器械内后,波峰3002和波谷3003向远离主体支架1中轴线的方向翘起的问题,从而降低主体支架1的近端与介入器械的内壁之间的摩擦力,使得主体支架1近端能够更顺利的脱离介入器械和释放于目标血管。沿主体支架1的轴向,各重合固定点位于各支撑骨架30上相近的波峰3002和波谷3003上,以使多组柔性束径构件40形成的多个重合固定点大致沿主体支架1的轴向方向排列延伸。Along the axial direction of the
可以理解,若主体支架1可以省略第二全固定骨架322和/或第二加强骨架323,则第二全固定骨架322和/或第二加强骨架323上的柔性束径构件40也相应省略。It can be understood that if the
请结合参阅图4及图7,图7为内嵌支架2的结构示意图。内嵌支架2的近端密封固定于开窗结构4,以使开窗结构4通过内嵌支架2与连通腔连通。内嵌支架2的远端向主体支架1的远端延伸,以使行腔内介入治疗的过程中的导丝入路更为方便,达到更加理想的腔内介入治疗效果。内嵌支架2包括内嵌覆膜21和多个内嵌骨架22,内嵌覆膜21呈管状结构,多个内嵌骨架22沿内嵌覆膜21的轴向依次排列。内嵌覆膜21的远端口为斜口,使得内嵌覆膜21的远端口靠近主体支架1中轴线的一侧相比内嵌覆膜21的远端口远离主体支架1中轴线的一侧更靠近主体支架1的近端。内嵌覆膜21的远端口为斜口的设计,有利于避免内嵌覆膜21的远端口的应力过于集中,应力过于集中容易导致内嵌支架2径向压缩后的内嵌支架2远端口难以自膨胀回复至预定形态。内嵌骨架22为开环结构,内嵌骨架22的开环口位于内嵌覆膜21靠近主体支架1内壁的一侧。开环结构的内嵌骨架22有利于降低主体支架1的径向尺寸,使得主体支架1更为顺利的从介入器械中释放。Please refer to FIG. 4 and FIG. 7 together. FIG. 7 is a schematic structural diagram of the embedded
分支支架3插接于内嵌支架2内,以使分支支架3与连通腔连通,从而将流经连通腔内的血流引入分支支架3,重建分支动脉。分支支架3的结构设计对分支动脉的远期通畅率有重大影响,分支支架3技术中提供了一种一体化分支型主动脉覆膜支架的技术以治疗Stanford B型夹层患者,但可能由于高流量血流的冲击、血管壁搏动范围广、不正确的主体支架1和分支支架3释放、定位或者血管截面呈不规则形状等问题,分支支架3自身的结构限制较难保证分支支架3的远期通畅率,分支支架3有可能发生闭塞的风险,较难保证介入治疗的中远期疗效,后期可能还需在分支支架3内放置裸支架20进行分支动脉干预以保证分支支架3的通畅率,增加并发症的发生风险。The
为了改善分支支架3插接于主体支架1后,分支支架3的远期通畅率较难保证的问题,沿分支支架3的轴向方向,分支支架3的不同区域采用不同的结构设计。In order to improve the problem that the long-term patency of the
请结合参照图1和图8,图8为分支支架3的结构示意图。分支支架3包括分支覆膜301以及固定于分支覆膜301的分支骨架组件。沿分支支架3的径向,分支覆膜301包括第一层膜和第二层膜(图中未示出),第一层膜位于分支支架3的连接腔的内侧,第二层膜位于分支支架3的外侧,第一层膜用于和血流接触,第二层膜用于和血管壁接触。分支骨架组件固定于第一层膜和第二层膜之间,例如分支骨架组件通过可以通过热压的方式固定于第一层膜和第二层膜之间。Please refer to FIG. 1 and FIG. 8 in conjunction. FIG. 8 is a schematic structural diagram of the
沿分支支架3的轴向,分支支架3包括从近端至远端依次连接的支撑段302、柔性段303和贴壁段304,支撑段302和贴壁段304为等径结构,柔性段303采用锥度设计。可以理解,支撑段302和贴壁段304为等径结构是相对柔性段303而言,在实际生产过程中,允许有±10%的误差,或者,支撑段302和贴壁段304在设计时具有小幅度的锥度设计,使得支撑段302和贴壁段304可能并非完全的等径结构。支撑段302的径向尺寸大于贴壁段304的径向尺寸,且支撑段302的径向尺寸大于内嵌支架2的径向尺寸。柔性段303的近端径向尺寸大于柔性段303的远端径向尺寸,柔性段303的近端和支撑段302连接,柔性段303的远端和贴壁段304连接。Along the axial direction of the
分支支架3还包括翻折段305,翻折段305设置有至少两段,至少两段翻折段305分别位于分支覆膜301的近端和远端,翻折段305位于连接腔内,且翻折段305固定于分支覆膜301的内周壁,例如翻折段305可以通过缝合、贴覆、冲压、贴设、镶设或热压等方式固定于分支覆膜301的内周壁。翻折段305由分支覆膜301的近端和远端向连接腔内翻折形成,即,至少一翻折段305与分支覆膜301的近端一体成形,至少一翻折段305与分支覆膜301的远端一体成形。由于分支覆膜301包括第一层膜和第二层膜,使得分支覆膜301为两层膜状物,且分支骨架组件位于两层膜状物之间,分支支架3径向压缩于介入器械的过程中,或者分支支架3在脱离介入器械以释放于分支动脉的过程中,分支支架3与介入器械之间的摩擦力、目标血管和分支动脉自身的脉动、不恰当地主体支架1和分支支架3释放、定位,都对两层膜状物有不同程度的分离考验,即,两层膜状物具有至少部分彼此分离的风险,导致分支支架3具有闭塞的风险,影响分支支架3的远期通畅率。至少两段翻折段305的设置,有利于改善第一层膜和第二层膜的近端和远端受到高流量血流的冲击、分支支架3压缩和释放过程中与介入器械之间的摩擦力、目标血管与分支动脉自身的脉动对分支支架3的冲击离或者不恰当的操作而至少部分分离的问题,降低分支支架3发生闭塞的风险,提高分支支架3的远期通畅率。翻折段305的轴向长度为1-5mm。The
分支骨架组件包括沿分支支架3的轴向依次排列的支撑骨环306、柔性骨环307和贴壁骨环308,支撑骨环306位于支撑段302,柔性骨环307从至少部分支撑段302、柔性段303、至少部分贴壁段304依次延伸,贴壁骨环308位于贴壁段304。The branch skeleton assembly includes a supporting
支撑骨环306包括多个第一波形环3061、至少一第二波形环3062以及连接骨3063,多个第一波形环3061、至少一第二波形环3062沿分支支架3的轴向依次排列,第二波形环3062位于第一波形环3061的远端侧,换而言之,第一波形环3061相比第二波形环3062更靠近分支支架3的近端。连接骨3063将多个第一波形环3061连接在一起。第一波形环3061和第二波形环3062均包括多个呈夹角依次相连的分支杆3064,沿分支支架3的周向上,相邻的两个夹角分别为波峰3002和波谷3003,波峰3002相比波谷3003更靠近分支支架3的近端。每个第一波形环3061均设有至少一个和连接骨3063固定的固定位,以使连接骨3063将多个第一波形环3061沿轴向相连。固定位位于每一第一波形环3061的分支杆3064上。固定位可以是通过缝合、贴覆、冲压、贴设、镶设、焊接或热压等方式形成,本实施例中,固定位为固定套3065,固定套3065将连接骨3063固定于每一第一波形环3061上的分支杆3064上。沿分支支架3的轴向,连接骨3063沿相连两个第一波形环3061的相邻支撑杆3001延伸,以使连接骨3063为一从支撑段302的近端至远端延伸的倾斜线性形。连接骨3063的设置,有利于改善分支支架3因介入器械的摩擦、血管的脉动、血流的冲击等原因而发生短缩的问题,或者减少短缩的幅度,同时起到增强支撑段302的径向支撑力的效果。连接骨3063为一倾斜线性形的设置,有利于降低连接骨3063因为与介入器械支架的摩擦或者因分支支架3的径向压缩和自膨胀回复至预定形态的过程中顶破第一层膜和第二层膜的风险。The supporting
根据本申请的示例性实施例,在其他实施方式中,例如请参阅图9,图9为连接骨3063与第一波形环3061的另一可能固定方式的结构示意图(仅示出部分第一波形环3061和部分连接骨3063)。至少部分固定位由每一第一波形环3061上连接骨3063所在的分支杆3064螺旋缠绕于所述连接骨3063而形成,即每一第一波形环3061上固定位所在的分支杆3064可以螺旋缠绕于连接骨3063上,使得连接骨3063能够更稳定地将多个第一波形环3061连接在一起,有利于进一步改善分支支架3发生短缩的问题,或者进一步减少短缩的幅度。每一第一波形环3061上固定位所在的分支杆3064可以螺旋缠绕于连接骨3063上的设置方式,还起到减少固定位的数量的效果,例如仅保留连接骨3063长度方向的两端上的固定套3065,固定位数量的减少,可以降低分支支架3与介入器械之间的摩擦力,降低固定套3065有可能顶破分支覆膜301的风险,减小介入器械的径向尺寸等。可以理解,在螺旋缠绕的基础上,还可以叠加缝合、贴覆、冲压、贴设、镶设、焊接或热压等固定方式。According to an exemplary embodiment of the present application, in other implementation manners, please refer to FIG. 9, for example, which is a structural schematic diagram of another possible fixing method between the connecting
柔性骨环307包括多个波形单元371,柔性骨环307由多个波形单元371首尾相接且沿第一层膜的外周连续螺旋排布形成的管状结构。波形单元371包括多个呈夹角依次相连的单元杆372,沿分支支架3的周向上,相邻的两个夹角分别为波峰3002和波谷3003,波峰3002相比波谷3003更靠近分支支架3的近端。第二波形环3062上的一分支杆3064上设有固定位,第二波形环3062上的固定位将柔性骨环307靠近分支支架3近端的一端固定于第二波形环3062上,有利于提高柔性骨环307在分支支架3轴向上的结构稳定性。The
贴壁骨环308的结构与支撑骨环306的结构相同,在此不再赘述。可以理解,贴壁骨环308的结构与支撑骨环306的结构相同,但第一波形环3061和第二波形环3062的数量可以不同。对于贴壁骨环308,贴壁骨环308的多个第一波形环3061、至少一第二波形环3062沿分支支架3的轴向依次排列,贴壁骨环308的第二波形环3062位于贴壁骨环308的第一波形环3061的近端侧,换而言之,贴壁骨环308的第一波形环3061相比贴壁骨环308的第二波形环3062更靠近分支支架3的远端。贴壁骨环308的第二波形环3062的一分支杆3064上设有固定位,贴壁骨环308的第二波形环3062上的固定位将柔性骨环307靠近分支支架3远端的一端固定于贴壁骨环308的第二波形环3062上,有利于进一步提高柔性骨环307在分支支架3轴向上的结构稳定性。The structure of the adherent bone ring 308 is the same as that of the supporting
分支支架3通过至少部分支撑段302插接于内嵌支架2内,支撑段302远离贴壁段304的一端延伸出内嵌支架2的远端,使得分支支架3能够更稳定地插接于内嵌支架2内,有利于改善植入支架发生位移的问题,从而有利于避免分支支架3因位移而受到挤压导致至少局部闭塞,提高分支动脉的远期通畅率;同时,支撑段302的径向尺寸大于内嵌支架2的径向尺寸能够较好的撑开内嵌支架2,有利于避免影响分支动脉的血通量。分支支架3的至少部分柔性段303、贴壁段304用于植入分支动脉内。若分支动脉(例如左锁骨动脉)与目标血管(例如主动脉弓5)之间的夹角为锐角(锐角为分支动脉与目标血管形成的夹角中远离心脏端一侧的夹角),柔性段303具有较好的柔顺性,能够适应弯曲的血管解剖结构,有利于降低由于分支动脉与目标血管之间形成锐角时分支支架3闭塞的风险。贴壁段304能够减少对血管壁的刺激,附着性好。沿分支支架3的轴向的不同区域采用不同的设计,可以使得分支支架3适应不同分支血管对分支支架3结构的不同需求。The
管状覆膜10、内嵌覆膜21、分支覆膜301均为生物相容性织物,包括但不限于机织或针织聚酯,例如聚对苯二甲酸乙二酯、聚对苯二甲酸乙二醇酯、聚丙交酯、聚乙交酯及其共聚物;氟化聚合物,例如聚四氟乙烯、膨体或电纺聚四氟乙烯和聚偏二氟乙烯;聚硅氧烷,例如聚二甲基硅氧烷;聚氨酯,例如聚醚聚氨酯、聚氨酯脲、聚醚聚氨酯脲、含有碳酸酯键的聚氨酯,含有硅氧烷链段的绕制镍钛和聚氨酯;硅酮、超高分子量聚乙烯、氟化乙烯丙烯共聚物或其他合适材料。本实施例以管状覆膜10和内嵌覆膜21采用PET材料、分支覆膜301采用e-PTFE材料举例说明,并不对管状覆膜10、内嵌覆膜21、分支覆膜301的使用材料进行限制。The tubular covering 10, the insert covering 21, and the branch covering 301 are all biocompatible fabrics, including but not limited to woven or knitted polyester such as polyethylene terephthalate, polyethylene terephthalate Glycol esters, polylactides, polyglycolides and their copolymers; fluorinated polymers such as polytetrafluoroethylene, expanded or electrospun polytetrafluoroethylene and polyvinylidene fluoride; polysiloxanes such as Polydimethylsiloxanes; Polyurethanes such as polyether polyurethanes, polyurethane ureas, polyether polyurethane ureas, polyurethanes containing carbonate linkages, wound nickel titanium and polyurethanes containing siloxane segments; silicones, ultra-high molecular weight Polyethylene, fluorinated ethylene propylene copolymer, or other suitable material. In this embodiment, the
支撑骨架30、内嵌骨架22和分支骨架均采用弹性材料,以使撑骨架、内嵌骨架22和分支骨架组件能够沿径向收缩或展开,即支撑骨架30、内嵌骨架22和分支骨架组件具有径向膨胀能力,可在外力作用下被压缩并在外力撤销后自膨胀或通过机械膨胀恢复至初始形状并保持初始形状,由此植入血管后可通过其径向支撑力贴覆血管壁。弹性材料包括但不限于镍钛合金、镍钛超弹性合金、钴铬镍钼合金、铜基形状记忆合金、铁基形状记忆合金、医用不锈钢合金或各种聚合物(例如聚降冰片烯、聚氨酯、聚乳酸共聚物等)等的一种或多种制成。The
在一分体式单内嵌分支覆膜支架的可能应用场景中,请参照图10,图10为分体式单内嵌分支覆膜支架用于重建主动脉弓5的场景示意图。血管可以是主动脉弓5,将分体式单内嵌分支覆膜支架释放于主动脉弓5内、且重建主动脉弓5上的至少一分支动脉(例如头臂干动脉、左颈总动脉和左锁骨动脉7等分支动脉)为例。将分体式单内嵌分支覆膜支架释放于主动脉弓5内,分体式单内嵌分支覆膜支架可以隔绝主动脉弓5形成的瘤腔8或者夹层破口。分体式单内嵌分支覆膜支架上的开窗结构4对准分支动脉的根部开口,将分支支架3的一端通过开窗结构4释放于内嵌支架2内,分支支架3的另一端释放于分支动脉内以重建主动脉弓5上的至少一分支动脉(例如头臂干动脉、左颈总动脉和左锁骨动脉7等分支动脉)。本实施例以重建左锁骨动脉为例。In a possible application scenario of a split-type single-embedded branch stent-graft, please refer to FIG. 10 , which is a schematic diagram of a scenario where a split-type single-embedded-branch covered stent is used for reconstruction of the
本申请第二实施例提供一种分体式单内嵌分支覆膜支架,请参阅图11,图11为主体支架1另一示例性结构示意图。本实施例与第一实施例提供的分体式单内嵌分支覆膜支架的不同之处在于,本实施例中至少一第一全固定骨架321的结构不同,沿主体支架1的轴向,开窗结构4位于至少一贴壁骨架31和至少一第一全固定骨架321之间,换而言之,至少一第一全固定骨架321位于开窗结构4的远端侧。本实施例可以省略第二全固定骨架322、第一加强骨架33和第二加强骨架323。The second embodiment of the present application provides a split-type single embedded branch covered stent, please refer to FIG. 11 , which is another exemplary structural diagram of the
本实施例中,至少一第一全固定骨架321上的相邻两个形成波谷3003的支撑杆3001围合形成加强部36,为了便于区分,将形成加强部36的两个支撑杆3001分别命名为第一支撑杆361及第二支撑杆362,第一支撑杆361的远端与第二支撑杆362的远端相连形成的波谷3003为加强波谷363。第一支撑杆361、第二支撑杆362和加强波谷363形成一围绕至少部分开窗结构4的半环状结构,有利于提高开窗结构4的贴壁性,起到更好的防内漏效果。In this embodiment, two
请结合参阅图12,图12为图11中A处的放大结构示意图。至少一第一全固定骨架321上远离主体支架1近端的一侧形成有一贴壁区,靠近主体支架1近端的一侧形成有一避位区。具体地,沿主体支架1的周向方向上,临近加强波谷363两侧的至少两个波谷3003和加强波谷363相比第一全固定骨架321上的其他波谷3003更远离主体支架1的近端,临近加强波谷363两侧的至少两个波峰3002相比第一全固定骨架321上的其他波峰3002更远离主体支架1的近端,为了便于区分,将临近加强波谷363两侧的至少两个波谷3003分别命名为第一贴壁波谷364和第二贴壁波谷365,临近加强波谷363两侧的至少两个波峰3002分别命名为第一避位波峰366和第二避位波峰367。沿主体支架1的周向方向上,第一贴壁波谷364和第二贴壁波谷365分别位于加强波谷363的两侧,第一避位波峰366和第二避位波峰367分别位于加强波谷363的两侧。形成第一避位波峰366的两个支撑杆3001以及形成第二避位波峰367的两个支撑杆3001的近端至第一全固定骨架321中形成其他波峰3002的支撑杆3001的近端之间的轴向长度即为避位区的轴向长度,避位区的长度可以是2-4mm,避位区的设置有利于避免主体支架1径向压缩或自膨胀回复至预定形态的过程中挤压开窗结构4,有利于开窗结构4自膨胀后较为顺利地回复至预定形态。形成第一贴壁波谷364的两个支撑杆3001、形成第二贴壁波谷365的两个支撑杆3001以及形成加强波谷363的两个支撑杆3001的远端至第一全固定骨架321中形成其他波谷3003的支撑杆3001的远端之间的轴向长度即为贴壁区的轴向长度,贴壁区的长度可以是3-5mm,贴壁区的设置起到增加开窗结构4周围的支撑骨架30的贴壁性的效果,有利于减少管状覆膜10的近端植入弯曲的目标血管后出现鸟嘴征,即有利于减少管状覆膜10的近端植入弯曲的目标血管后,主体支架1近端的小弯侧6与血管壁较难紧密贴合,主体支架1近端的小弯侧6与血管壁之间容易出现间隙而导致发生Ia型内漏的问题。Please refer to FIG. 12 in conjunction with FIG. 12 . FIG. 12 is a schematic diagram of an enlarged structure at point A in FIG. 11 . At least one first
以上均为本申请的较佳实施例,并非依此限制本申请的保护范围,故:凡依本申请的结构、形状、原理所做的等效变化,均应涵盖于本申请的保护范围之内。All of the above are preferred embodiments of the application, and are not intended to limit the protection scope of the application. Therefore, all equivalent changes made according to the structure, shape, and principle of the application should be covered by the protection scope of the application. Inside.
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| CN116370144A (en) * | 2023-05-19 | 2023-07-04 | 杭州唯强医疗科技有限公司 | Vascular Stents and Systems |
| CN118845296B (en) * | 2024-09-27 | 2024-12-10 | 北京华脉泰科医疗器械股份有限公司 | Aortic tectorial membrane support |
| CN120000392B (en) * | 2025-04-21 | 2025-07-11 | 四川国屹医疗科技有限公司 | Multi-branch tectorial membrane support |
| CN120000391B (en) * | 2025-04-21 | 2025-08-08 | 四川国屹医疗科技有限公司 | Split type multi-branch intraoperative support |
| CN120305005B (en) * | 2025-06-17 | 2025-08-22 | 上海浦东复旦大学张江科技研究院 | Ascending aorta covered stent |
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| CN112451170B (en) * | 2016-12-28 | 2022-09-02 | 先健科技(深圳)有限公司 | Covered stent |
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| CN209107690U (en) * | 2018-05-30 | 2019-07-16 | 杭州唯强医疗科技有限公司 | Segmented overlay film frame |
| CN114681113A (en) * | 2020-12-29 | 2022-07-01 | 上海微创心脉医疗科技(集团)股份有限公司 | Covered stent system |
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| CN114652495B (en) * | 2022-05-18 | 2022-08-30 | 上海微创心脉医疗科技(集团)股份有限公司 | Covered stent |
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