CN202960834U - Covered stent for restorative treatment in integrated two-branch vascular chamber of aortic arch - Google Patents

Abstract

Translated fromChinese

本实用新型涉及一种用于主动脉弓部一体二分支血管腔内修复治疗的覆膜支架。由裸体多波形柱状单圈一和外覆管状膜的多波形柱状单圈二、多个多波形柱状单圈三组成。在中部设有一个楔形槽，楔形槽内有直分支支架和斜形分支支架。本实用新型利用楔形槽内二分支支架预留了主动脉弓上头臂干和左劲总动脉血流通道，并且将二分支支架的释放位置设计在主动脉弓部血管腔内。本实用新型适用于所有需要行主动脉弓部腔内修复治疗的患者，可隔绝累及主动脉弓部和升主动脉的主动脉病变、可重建重要分支动脉的血流，适用范围广、释放程序简单、手术时间短、手术成功率高、可避免定制支架、可批量化生产，并可用于急诊手术，还可适用于实验用动物犬主动脉弓部置换。

The utility model relates to a covered stent used for intracavitary repair treatment of an aortic arch with two branches in one body. It is composed of naked multi-wave columnar single-turn I, multi-wave columnar single-turn II covered with tubular film, and multiple multi-wave columnar single-turn III. A wedge-shaped groove is arranged in the middle, and there are straight branch supports and oblique branch supports in the wedge-shaped groove. The utility model uses the two-branch stent in the wedge-shaped groove to reserve blood flow channels of the brachiocephalic trunk and the left common artery on the aortic arch, and designs the release position of the two-branch stent in the vascular cavity of the aortic arch. The utility model is suitable for all patients who need intracavitary repair of the aortic arch, can isolate the aortic lesion involving the aortic arch and the ascending aorta, and can rebuild the blood flow of important branch arteries. It has wide application range, simple release procedure and short operation time. It is short, has a high success rate of operation, can avoid customized stents, can be mass-produced, and can be used for emergency surgery, and can also be used for aortic arch replacement in experimental animals.

Description

Translated fromChinese

用于主动脉弓部一体二分支血管腔内修复治疗的覆膜支架Stent-graft for endovascular repair of one-body two-branch vessels in the aortic arch

技术领域technical field

本实用新型涉及一种用于主动脉弓部一体二分支血管腔内修复治疗的覆膜支架。The utility model relates to a covered stent used for intracavitary repair treatment of an aortic arch with two branches in one body.

背景技术Background technique

目前采用血管腔内支架进行腔内修复治疗治疗胸主动脉瘤疗效好，并得到了飞速发展。但累及头臂干、左颈总动脉和左锁骨下动脉开口的主动脉弓部动脉瘤一直是该治疗技术的难点。传统的方法使用开窗支架，但其不适用于头臂干、左劲总动脉、左锁骨下动脉根部的动脉瘤。也有使用直筒支架直接封堵了主动脉弓上左锁骨下动脉，但不能很好地保留左锁骨下动脉的血流通过，适用范围较为局限。At present, the use of endovascular stents for endovascular repair in the treatment of thoracic aortic aneurysm has a good effect and has been developed rapidly. However, aortic arch aneurysms involving the brachiocephalic trunk, left common carotid artery, and left subclavian artery ostium have always been difficult to treat. The traditional approach uses a fenestrated stent, but it is not suitable for aneurysms of the brachiocephalic trunk, left common carotid artery, or root of the left subclavian artery. There is also a straight tube stent used to directly block the left subclavian artery on the aortic arch, but the blood flow of the left subclavian artery cannot be well preserved, and the scope of application is relatively limited.

有使用主动脉弓部三分支支架，但其分支在主动脉弓上主动脉血管腔之外，支架只能准切地释放在主动脉弓部头臂干、左劲总动脉、左锁骨下动脉内。而每个病人的血管走行不尽相同。一旦发生血管走行变异（临床上，该变异发生率较高），支架与血管就不相匹配，就不能完成这一治疗。另外，支架释放时要求分支支架分别准确地释放在头臂干、左劲总动脉、左锁骨下动脉，哪一个分支支架的释放失败都会导致整个手术失败。为此，本申请人申请了《用于主动脉弓部一体三分支血管腔内修复治疗的覆膜支架》（CN2010101712019.CN201220247582x），由金属支架与管状膜组成；金属支架由一个多波形柱状单圈一、多波形柱状单圈二和多个多波形柱状单圈三构成；多波形柱状单圈一为一裸体支架，多波形柱状单圈二、多波形柱状单圈三外覆管状膜；在第一至第五个多波形柱状单圈三之间的覆膜支架上设有一个楔形槽，楔形槽内有一个直分支支架、斜形分支支架一、斜形分支支架二，其设计了3个分支，预留了主动脉弓上头臂干、左劲总动脉、左锁骨下动脉的血流通道。但是在实际临床中，有些病人并不一定需要3支血管全部再通。而且能少释放一个分支血管支架，均能减少病人费用。Three-branch stents are used in the aortic arch, but their branches are outside the aortic lumen on the aortic arch, and the stent can only be accurately released in the brachiocephalic trunk, left common carotid artery, and left subclavian artery of the aortic arch. And every patient's blood vessels run differently. Once the variation of vascular course occurs (clinically, the incidence of this variation is high), the stent does not match the blood vessel, and the treatment cannot be completed. In addition, when the stent is released, the branch stents are required to be accurately released in the brachiocephalic trunk, left common carotid artery, and left subclavian artery. Failure to release any branch stent will lead to the failure of the entire operation. For this reason, the applicant applied for "Stent Graft for Endovascular Repair of One-body Three-Branch Vessel of Aortic Arch" (CN2010101712019.CN201220247582x), which consists of a metal stent and a tubular membrane; , multi-wave columnar single-turn two and multiple multi-wave columnar single-turn three; multi-waveform columnar single-turn one is a naked support, and multi-waveform columnar single-turn two and multi-waveform columnar single-turn three are covered with a tubular film; in the first There is a wedge-shaped groove on the covered stent between the fifth multi-wave columnar single-turn three, and there is a straight branch stent, oblique branch stent 1, and oblique branch stent 2 in the wedge-shaped groove, and three branches are designed , the blood flow channels of the brachiocephalic trunk, left common carotid artery, and left subclavian artery on the aortic arch are reserved. However, in actual clinical practice, some patients do not necessarily require recanalization of all three blood vessels. Moreover, one less branch vascular stent can be released, which can reduce the cost of patients.

发明内容Contents of the invention

本实用新型的目的是针对上述现状，旨在提供一种能隔绝累及主动脉弓部和升主动脉的主动脉病变、可重建重要分支动脉的血流、避免定制支架，适用范围广、支架释放程序简单、手术成功率高、手术并发症少，可以批量生产并可用于急诊手术的用于主动脉弓部一体二分支血管腔内修复治疗的覆膜支架。The purpose of this utility model is to address the above-mentioned current situation, aiming to provide a kind of aortic lesion that can isolate the aortic arch and ascending aorta, can rebuild the blood flow of important branch arteries, avoid customized stents, has a wide range of applications, and the stent release procedure is simple , high surgical success rate, less surgical complications, can be mass-produced and can be used in emergency surgery for the endoluminal repair of the aortic arch with two branches of the stent graft.

本实用新型目的的实现方式为，用于主动脉弓部一体二分支血管腔内修复治疗的覆膜支架，由金属支架与管状膜组成；金属支架由一个多波形柱状单圈一、一个多波形柱状单圈二和多个多波形柱状单圈三构成；多波形柱状单圈一为一裸体支架，多波形柱状单圈二、多波形柱状单圈三外覆管状膜；多波形柱状单圈一与多波形柱状单圈二用丝线缝合在一起，在覆膜支架的中间部设有一个楔形槽，楔形槽内有一个直分支支架和斜形分支支架；除多波形的柱状单圈一外，其余金属支架通过管状膜连接一起，成为一个完整的覆膜支架。The purpose of this utility model is achieved in that the covered stent for intracavitary repair of the two branches of the aortic arch is composed of a metal stent and a tubular membrane; Circle two and multiple multi-wave columnar single circle three; multi-wave columnar single circle one is a naked support, multi-wave columnar single circle two, multi-waveform columnar single circle three are covered with tubular membrane; multi-wave columnar single circle one and multiple The corrugated columnar single-circle two are sutured together with silk thread, and there is a wedge-shaped groove in the middle of the covered stent, and there is a straight branch stent and oblique branch stent in the wedge-shaped groove; except for the multi-wave columnar single-circle one, other metal The stents are joined together by tubular membranes to form a complete stent graft.

本实用新型在覆膜支架的中间部设有一个楔形槽，槽内有直分支支架和斜形分支支架，利用楔形槽内有直分支支架和斜形分支支架预留了主动脉弓上头臂干和左劲总动脉的血流通道，并且将有直分支支架和斜形分支支架的释放位置设计在主动脉弓部血管腔内。正是因为将有直分支支架和斜形分支支架的释放位置通过楔形槽设计在主动脉弓血管腔内，使得本实用新型定位只需要将分支侧朝向分动动脉开口，而不需要准确到相应主动脉弓上头臂干和左颈总动脉开口，故有效地降低了手术操作难度，缩短了手术时间。由于楔形槽的存在，分支直筒或喇叭型支架可以在楔形槽内适当调整角度、适度弯曲，主动脉弓上头臂干和左劲总动脉再通不受解剖学差异的影响，直接通过二次释放直筒或喇叭型支架就能连接到主动脉弓血管腔内的分支支架上。避免了定制支架耗费的时间，而且可以批量生产，可应用于急诊手术。The utility model is provided with a wedge-shaped groove in the middle part of the covered stent, and there are straight branch brackets and oblique branch brackets in the groove. Utilizing the straight branch brackets and oblique branch brackets in the wedge-shaped groove, the upper arm trunk and the left side of the aortic arch are reserved. The blood flow channel of the common carotid artery, and the release position of the straight branch stent and the oblique branch stent is designed in the vessel lumen of the aortic arch. It is precisely because the release position of the straight branch stent and the oblique branch stent is designed in the aortic arch vessel cavity through the wedge-shaped groove, so that the positioning of the utility model only needs to orient the branch side towards the opening of the arterial artery, and does not need to be accurate to the top of the corresponding aortic arch The opening of the arm trunk and the left common carotid artery effectively reduces the difficulty of operation and shortens the operation time. Due to the existence of the wedge-shaped groove, the angle of the branched straight or horn-shaped stent can be properly adjusted and moderately bent in the wedge-shaped groove. The recanalization of the brachiocephalic trunk on the aortic arch and the left common carotid artery is not affected by anatomical differences. The trumpet-shaped stent can be connected to the branch stent in the lumen of the aortic arch vessel. The time-consuming custom-made stent is avoided, and it can be mass-produced, which can be applied to emergency surgery.

采用本实用新型保留了主动脉弓部重要分支动脉血管的血流，适用于适用于所有需要行主动脉弓部腔内修复治疗的患者。本实用新型能提供一种能隔绝累及主动脉弓部和升主动脉的主动脉病变、可重建重要分支动脉的血流，避免定制支架、可以批量生产，并可用于急诊手术，适用范围广、释放程序简单、手术成功率高、手术并发症少。本实用新型还可适用于实验用动物犬主动脉弓部置换。The utility model preserves the blood flow of important branch arterial vessels of the aortic arch, and is suitable for all patients who need intracavitary repair treatment of the aortic arch. The utility model can provide a kind of aortic lesion that can isolate the aortic arch and ascending aorta, can rebuild the blood flow of important branch arteries, avoid custom-made stents, can be mass-produced, and can be used for emergency surgery. It has a wide range of applications and release procedures. Simple, high surgical success rate, less surgical complications. The utility model is also applicable to the replacement of the aortic arch of the experimental animal dog.

附图说明Description of drawings

图1是本实用新型的整体结构示意图。Fig. 1 is a schematic diagram of the overall structure of the utility model.

具体实施方式Detailed ways

参照图1，本实用新型由金属支架与管状膜组成。金属支架由一个多波形柱状单圈一1、一个多波形柱状单圈二2和多个多波形柱状单圈三6构成。多波形柱状单圈一1为裸体支架。多波形柱状单圈二2、多个多波形柱状单圈三6外覆管状膜。在覆膜支架的中间部设有一个楔形槽4，楔形槽内4有直分支支架3和斜形分支支架5。除多波形的柱状单圈一1外，其余金属支架通过管状膜连接一起。多波形柱状单圈一1与多波形柱状单圈二2用丝线缝合在一起，成为一个完整的覆膜支架。With reference to Fig. 1, the utility model is made up of metal support and tubular film. The metal support is composed of a multi-wave columnar single-turn 1, a multi-waveform columnar single-turn 2 and multiple multi-waveform columnar single-turn 3 6. The multi-wave columnar single circle-1 is a naked support. Multi-wave columnar single-circle 2 2, multiple multi-wave columnar single-circle 3 6 covered with tubular membrane. A wedge-shaped groove 4 is arranged in the middle part of the stent-graft, and there are straight branch brackets 3 and oblique branch brackets 5 in the wedge-shaped groove 4 . Except for the multi-wave columnar single circle-1, the rest of the metal stents are connected together by tubular membranes. The multi-wave columnar single-turn 1 and the multi-wave columnar single-turn 2 2 are sutured together with silk thread to form a complete stent graft.

所述的多波形柱状单圈三6的单圈波数多于多波形柱状单圈2二，波形小于柱状单圈二。The single-turn wave number of the multi-waveform columnar single-turn 36 is more than the multi-waveform columnar single-turn 22, and the waveform is smaller than the columnar single-turn 2.

所述的多波形柱状单圈采用具有良好生物相容性、化学稳定性和机械物理性能的医用不锈钢合金圈。所述管状膜为聚四氟乙烯膜、聚酯纤维膜、聚酰胺膜或聚丙烯膜，以满足植入人体的要求。The multi-wave columnar single coil adopts a medical stainless steel alloy coil with good biocompatibility, chemical stability and mechanical and physical properties. The tubular membrane is a polytetrafluoroethylene membrane, a polyester fiber membrane, a polyamide membrane or a polypropylene membrane, so as to meet the requirement of being implanted into a human body.

多波形柱状单圈三6的单圈波数多于多波形柱状单圈二2，波形小于柱状单圈二2。由于波形小，波间间隔少，能够适应非规则截面形状的血管，并有效的增加大动脉覆膜支架近端的贴壁效果，因此可以显著的减少近端内漏的可能性。使支架释放手术并发症少、术后患者的存活率高。The single-turn wave number of the multi-waveform columnar single-turn three 6 is more than that of the multi-waveform columnar single-turn two 2, and the waveform is smaller than the columnar single-turn two 2. Due to the small waveform and small interval between waves, it can adapt to blood vessels with irregular cross-sectional shapes and effectively increase the wall-attachment effect of the proximal end of the aortic stent graft, so it can significantly reduce the possibility of proximal endoleak. The stent release operation has fewer complications, and the postoperative survival rate of the patient is high.

为能适用于血管大小不同、位置各异的患者，依据中国成年人升主动脉直径情况，本发明可以设计成不同的型号。由多波形柱状单圈二2和多个多波形柱状单圈三6构成的主体支架直径34±5mm，长220±55mm。楔形槽4槽深10±2mm，槽长50±20mm。直分支支架3的直径10±2mm，长15±2 mm；或由多波形柱状单圈二2和多个多波形柱状单圈三6构成的主体支架上段直径34±5mm，下段直径25±5 mm，长220±55mm，使之更适合主动脉弓部解剖形态。In order to be applicable to patients with different sizes and positions of blood vessels, the present invention can be designed into different models according to the diameter of the ascending aorta of Chinese adults. The main body bracket composed of multi-wave columnar single-turn 2 2 and multiple multi-wave columnar single-turn 3 6 has a diameter of 34±5mm and a length of 220±55mm. The wedge-shaped groove 4 has a groove depth of 10±2mm and a groove length of 50±20mm. The straight branch stent 3 has a diameter of 10±2 mm and a length of 15±2 mm; or a main body stent composed of multi-wave columnar single-turn 2 and multiple multi-wave columnar single-turn 3 6 has an upper diameter of 34±5 mm and a lower diameter of 25±5 mm. mm, 220±55mm in length, making it more suitable for the anatomical shape of the aortic arch.

斜形分支支架5的直径为8.5±1.5mm，长15±2 mm。The diameter of the oblique branch support 5 is 8.5 ± 1.5mm, and the length is 15 ± 2 mm.

本实用新型在覆膜支架的中间部设有一个楔形槽4，楔形槽4深度相对主体支架直径较浅，尚不构成主动脉缩窄的症状，不影响降主动脉远端的血流供应。楔形槽4内有直分支支架3和斜形分支支架5，分别保留了主动脉弓上头臂干和左劲总动脉二次释放直筒或喇叭支架的通路，并且将二分支支架的释放位置设计在主动脉弓部血管腔内。正是因为将二分支支架的释放位置通过楔形槽4设计在主动脉弓血管腔内，使得支架定位只需要将楔形槽4侧朝向分动动脉开口，而不需要准确到相应主动脉弓上头臂干和左颈总动脉开口，故有效地降低了手术操作难度，缩短了手术时间。由于楔形槽的存在，分支直筒或喇叭型支架可以在楔形槽内适当调整角度、适度弯曲，主动脉弓上头臂干和左劲总动脉的再通不受解剖学差异的影响，直接通过二次释放直筒或喇叭型支架就能连接到主动脉弓血管腔内的分支支架上。避免了定制支架耗费的时间，而且支架可以批量生产，可应用于急诊手术。The utility model is provided with a wedge-shaped groove 4 in the middle part of the covered stent, and the depth of the wedge-shaped groove 4 is shallower than the diameter of the main body stent, which does not constitute the symptoms of aortic coarctation and does not affect the blood flow supply at the distal end of the descending aorta. There are straight branch stents 3 and oblique branch stents 5 inside the wedge-shaped groove 4, respectively retaining the channels for the secondary release of the straight or trumpet stents on the upper brachiocephalic trunk of the aortic arch and the left common carotid artery, and the release position of the two-branch stent is designed in the aortic arch Intravascular cavity. It is precisely because the release position of the two-branch stent is designed in the aortic arch vessel lumen through the wedge-shaped groove 4, so that the positioning of the stent only needs to face the side of the wedge-shaped groove 4 toward the opening of the arterial artery, and does not need to be accurate to the brachiocephalic trunk and left carotid trunk of the corresponding aortic arch. The opening of the common artery effectively reduces the difficulty of operation and shortens the operation time. Due to the existence of the wedge-shaped groove, the angle of the branched straight or trumpet-shaped stent can be properly adjusted and moderately bent in the wedge-shaped groove. The recanalization of the brachiocephalic trunk and the left common carotid artery on the aortic arch is not affected by anatomical differences. Or trumpet-shaped stents can be connected to branch stents in the lumen of the aortic arch vessel. The time-consuming custom-made stent is avoided, and the stent can be mass-produced and applied to emergency surgery.

在实施手术时，楔形槽4内的直分支支架3、斜形分支支架5分别用来重建主动脉弓上头臂干和左颈总动脉。将裸体支架1定位于升主动脉，楔形槽4侧朝向分动动脉开口，通过在头臂干和左颈总动脉内送入直筒或喇叭型支架与本覆膜支架的对应分支连接即可。对于左锁骨下动脉，如果可以不用再通，可以使用动脉塞进行封闭；如果需要再通，可以在在腔内修复术之前在患者颈部作一小切口进行“左颈总动脉-左锁骨下动脉”搭桥转流（即传统的“杂交”手术）即可。During the operation, the straight branch stent 3 and the oblique branch stent 5 in the wedge-shaped groove 4 are respectively used to reconstruct the upper brachiocephalic trunk of the aortic arch and the left common carotid artery. Position the bare stent 1 on the ascending aorta, with the 4 sides of the wedge-shaped groove facing the opening of the diverter artery, and connect the corresponding branch of the covered stent by sending a straight or trumpet-shaped stent into the brachiocephalic trunk and left common carotid artery. For the left subclavian artery, if recanalization is not necessary, arterial plugs can be used for closure; if recanalization is required, a small incision in the patient's neck can be performed before endovascular repair. Artery" bypass bypass (that is, the traditional "hybrid" surgery).

本实用新型更改较小尺寸后还可适用于实验用动物犬主动脉弓部置换，因为动物犬没有左锁骨下动脉。The utility model is also applicable to the replacement of the aortic arch of the experimental animal dog after the smaller size is changed, because the animal dog has no left subclavian artery.

Claims (7)

1. be used for the overlay film frame of aortic arch one two branch vessel intracavity repairing and treatings, formed by metal rack and tubular film; Metal rack is made of the individual pen of waveform column more than waveform column individual pen 2 more than, and a plurality of many waveforms column individual pen three; Many waveforms column individual pen one is a nude support, many waveforms column individual pen two, many waveforms column individual pen three external coated layer shape films; Many waveforms column individual pen one and many waveforms column individual pen dual-purpose silk suture is characterized in that being provided with a wedge-shaped slot at the middle part together, and a straight branch stent and oblique branch stent are arranged in wedge-shaped slot; Except the column individual pen one of many waveforms, all the other metal racks connect by tubular film, become a complete overlay film frame.

2. the overlay film frame for aortic arch one two branch vessel intracavity repairing and treatings according to claim 1, it is characterized in that the individual pen wave number of many waveforms column individual pen three (6) more than many waveforms column individual pen two (2), waveform is less than many waveforms column individual pen two (2).

3. the overlay film frame for aortic arch one two branch vessel intracavity repairing and treatings according to claim 1, it is characterized in that the main body rack diameter 34 ± 5mm by many waveforms column individual pen two (2) and a plurality of many waveforms column individual pen three (6) formations, long 220 ± 55mm.

4. the overlay film frame for aortic arch one two branch vessel intracavity repairing and treatings according to claim 1, is characterized in that wedge-shaped slot (4) groove depth 10 ± 2mm, flute length 50 ± 20mm; Diameter 10 ± the 2mm of straight branch stent (3), long 15 ± 2 mm; The diameter of oblique branch stent (5) is 8.5 ± 1.5mm, long 15 ± 2 mm.

5. the overlay film frame for aortic arch one two branch vessel intracavity repairing and treatings according to claim 1, is characterized in that described many waveforms column individual pen adopts the medical stainless steel alloy ring with good biocompatibility, chemical stability and mechanical and physical performance.

6. the overlay film frame for aortic arch one two branch vessel intracavity repairing and treatings according to claim 1, it is characterized in that the main body rack epimere diameter 34 ± 5mm by many waveforms column individual pen two (2) and a plurality of many waveforms column individual pen three (6) formations, hypomere diameter 25 ± 5 mm, long 220 ± 55mm.

7. the overlay film frame for aortic arch one two branch vessel intracavity repairing and treatings according to claim 1, is characterized in that tubular film is poly tetrafluoroethylene, polyester fiber film, polyamide membrane or polypropylene screen.