CN107174376A - A kind of arteria covering membrane supporter - Google Patents
A kind of arteria covering membrane supporter Download PDFInfo
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- CN107174376A CN107174376A CN201710560426.6A CN201710560426A CN107174376A CN 107174376 A CN107174376 A CN 107174376A CN 201710560426 A CN201710560426 A CN 201710560426A CN 107174376 A CN107174376 A CN 107174376A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/077—Stent-grafts having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
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- Gastroenterology & Hepatology (AREA)
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Abstract
本发明公开了一种动脉覆膜支架,所述覆膜支架(2)包括覆膜支架段(7)和裸支架段(6);所述覆膜支架段(7)包括波形环状金属丝(3)、覆膜(4)和纤毛(5);所述波形环状金属丝(3)包括多圈,每圈沿覆膜(4)的轴向依次分布;所述纤毛(5)附着于波形环状金属丝上,且附着在覆膜支架段(7)两端环形金属丝(3)上的纤毛呈短而密状态分布;在覆膜支架段(7)中间段的环形金属丝(3)上的纤毛呈长而稀疏状态分布。本发明提供的覆膜支架中设置的纤毛可以缓冲支架对瘤颈处血管壁的压应力,减少支架对瘤颈的刺激;可以增加覆膜支架与瘤颈之间的结合面积和摩擦力,增加支架稳定性,降低支架移位发生率。
The invention discloses an arterial stent graft, the stent graft (2) comprises a stent graft segment (7) and a bare stent segment (6); the stent graft segment (7) comprises a corrugated annular metal wire (3), covering film (4) and cilium (5); Described corrugated circular metal wire (3) comprises multiple circles, and each circle is distributed successively along the axial direction of covering film (4); Described cilium (5) adheres to On the corrugated ring wire, the cilia attached to the ring wire (3) at both ends of the stent graft segment (7) are distributed in a short and dense state; the ring wire at the middle of the stent graft segment (7) (3) The cilia are long and sparsely distributed. The cilia provided in the stent-graft provided by the present invention can buffer the compressive stress of the stent on the vessel wall at the neck of the tumor, reduce the stimulation of the stent to the neck of the tumor; increase the bonding area and friction between the stent-graft and the neck of the tumor, increase The stability of the stent reduces the incidence of stent displacement.
Description
技术领域technical field
本发明涉及医疗器械技术领域,尤其涉及一种动脉覆膜支架。The invention relates to the technical field of medical devices, in particular to an arterial covered stent.
背景技术Background technique
现有主动脉瘤、主动脉夹层动脉瘤属于主动脉常见疾病,致死率高。目前这两种疾病治疗方式以应用覆膜支架进行腔内隔绝术为主。主动脉覆膜支架置入术中各种“内漏”、支架移位现象是手术的两个最大难点。Existing aortic aneurysm and aortic dissection are common diseases of the aorta with a high mortality rate. At present, the treatment of these two diseases is mainly based on the application of endovascular exclusion with covered stents. Various "endoleaks" and stent displacement phenomena during the implantation of aortic stent grafts are the two biggest difficulties in the operation.
“内漏”是腔内治疗主动脉瘤最常见的并发症之一,是指覆膜支架植入术后,血液仍经由各种途径继续流入瘤腔内的现象,其原因是支架释放后未能完全隔绝瘤腔与动脉血流之间的交通。内漏可导致瘤腔在覆膜支架修复术后仍持续增大,最终破裂,导致患者死亡。支架移位也是主动脉疾病腔内修复术的另一常见并发症。支架释放后未能按照原计划有效的锚定在病变部位,发生位置移动,不仅妨碍支架发挥效果,还会危及动脉发出的分支。"Endoleak" is one of the most common complications of endovascular treatment of aortic aneurysms. It refers to the phenomenon that blood continues to flow into the aneurysm cavity through various channels after the stent graft is implanted. It can completely isolate the communication between the tumor cavity and the arterial blood flow. Endoleaks can lead to continued enlargement of the tumor cavity after stent-graft repair and eventually rupture, resulting in death of the patient. Stent migration is another common complication of endovascular repair of aortic disease. After the stent is released, it fails to be effectively anchored in the lesion according to the original plan, and the position shifts, which not only hinders the effect of the stent, but also endangers the branches of the artery.
现有支架对于“内漏”和“移位”的预防手段有限,且常常容易造成对动脉壁的伤害。对于近肾动脉的腹主动脉瘤、近锁骨下动脉的胸主动脉瘤、夹层动脉瘤,由于瘤颈短、瘤壁脆弱,常规的覆膜支架修复手术极为困难,而应用分支支架、开窗支架、烟囱技术等复杂操作,手术时间长,手术成功率不高,并发症比较多。有的时候还难以避免的牺牲一侧肾动脉或牺牲左侧锁骨下动脉。Existing stents have limited preventive measures for "endoleak" and "displacement", and often easily cause damage to the arterial wall. For abdominal aortic aneurysms near the renal artery, thoracic aortic aneurysms near the subclavian artery, and dissecting aneurysms, due to the short aneurysm neck and fragility of the aneurysm wall, it is extremely difficult to repair conventional stent grafts. Complicated operations such as stent and chimney technique require a long operation time, a low success rate and many complications. Sometimes it is unavoidable to sacrifice one side of the renal artery or sacrifice the left subclavian artery.
发明内容Contents of the invention
为解决上述技术问题,本发明的目的是提供一种动脉覆膜支架,该支架在原有的动脉覆膜支架上增加了纤毛,纤毛可以缓冲支架对瘤颈处血管壁的压应力,减少支架对瘤颈的刺激;可以增加覆膜支架与瘤颈之间的结合面积和摩擦力,增加支架稳定性,降低支架移位发生率;可以使支架与瘤颈之间结合更为紧密,防止I型内漏;同时纤毛的吸附作用、机械重叠作用和激活凝血的作用,可以在支架外围快速致栓,快速血栓化的瘤腔发生各型内漏的风险迅速降低。In order to solve the above-mentioned technical problems, the purpose of the present invention is to provide a kind of arterial stent-graft, this stent has increased cilia on the original arterial stent-graft, and cilia can buffer the compressive stress of stent to the blood vessel wall at the neck of aneurysm, reduce the stent's impact on the aneurysm neck. Stimulation of the tumor neck; it can increase the bonding area and friction between the covered stent and the tumor neck, increase the stability of the stent, and reduce the incidence of stent displacement; it can make the combination between the stent and the tumor neck more tightly, preventing type I Endoleak; at the same time, the adsorption of cilia, mechanical overlap and activation of blood coagulation can quickly induce thrombus around the periphery of the stent, and the risk of various types of endoleaks in the rapidly thrombosed tumor cavity is rapidly reduced.
本发明的目的通过以下的技术方案来实现:The purpose of the present invention is achieved through the following technical solutions:
一种动脉覆膜支架,包括覆膜支架段(7)和裸支架段(6);所述覆膜支架段(7)包括波形环状金属丝(3)、覆膜(4)和纤毛(5);An arterial stent graft comprises a stent graft segment (7) and a bare stent segment (6); the stent graft segment (7) comprises a corrugated annular metal wire (3), a membrane (4) and cilia ( 5);
所述波形环状金属丝(3)包括多圈,每圈沿覆膜(4)的轴向依次分布;The corrugated annular metal wire (3) includes multiple turns, and each turn is distributed sequentially along the axial direction of the covering film (4);
所述纤毛(5)附着于波形环状金属丝上,且附着在覆膜支架段(7)两端环形金属丝(3)上的纤毛呈短而密状态分布;在覆膜支架段(7)中间段的环形金属丝(3)上的纤毛呈长而稀疏状态分布。The cilia (5) are attached to the corrugated ring wires, and the cilia attached to the ring wires (3) at both ends of the stent graft segment (7) are distributed in a short and dense state; in the stent graft segment (7) ) The cilia on the ring wire (3) in the middle section are distributed in a long and sparse state.
与现有技术相比,本发明的一个或多个实施例可以具有如下优点:Compared with the prior art, one or more embodiments of the present invention may have the following advantages:
缓冲支架对瘤颈处血管壁的压应力,使支架对瘤颈的压应力均匀分布,减少支架对瘤颈的刺激;Buffer the compressive stress of the stent on the vessel wall at the neck of the tumor, so that the compressive stress of the stent on the neck of the tumor is evenly distributed, reducing the stimulation of the stent on the neck of the tumor;
机械填充作用致使瘤颈处致密的微纤毛使支架与瘤颈之间结合更为紧密,防止I型内漏;增加覆膜支架与瘤颈之间的结合面积和摩擦力,使支架更为稳定。The mechanical filling effect causes the dense microcilia at the neck of the tumor to make the stent and the neck more tightly combined to prevent type I endoleak; increase the bonding area and friction between the stent graft and the neck of the tumor to make the stent more stable .
利用纤毛的吸附作用、机械重叠作用和激活凝血的作用,在支架外围快速致栓,快速血栓化的瘤腔发生各型内漏的风险迅速降低。微纤毛在动脉瘤内重叠、交错,可在动脉瘤内部、瘤颈处搭建致密网格(“脚手架”),有效减少流经动脉瘤瘤颈的血流,同时吸附血小板和凝血物质,有利于在瘤体内和瘤颈处的形成更为稳定的血栓。Nylon和PGLA材质分别通过凝血活性、诱导组织反应的活性,快速稳定致栓,有效防止各型内漏。Utilizing the adsorption effect of cilia, mechanical overlapping effect and activation of coagulation effect, the thrombus can be rapidly induced around the periphery of the stent, and the risk of various types of endoleaks in the rapidly thrombusized tumor cavity is rapidly reduced. The microcilia overlap and stagger in the aneurysm, and can build a dense grid ("scaffolding") inside the aneurysm and at the neck of the aneurysm, effectively reducing the blood flow through the aneurysm neck, and at the same time adsorbing platelets and coagulation substances, which is beneficial to Formation of more stable thrombus in the tumor body and neck. Nylon and PGLA materials can quickly and stably cause thrombus through blood coagulation activity and activity of inducing tissue reaction respectively, and effectively prevent various types of endoleaks.
附图说明Description of drawings
附图用来提供对本发明的进一步理解,并且构成说明书的一部分,与本发明的实施例共同用于解释本发明,并不构成对本发明的限制。在附图中:The accompanying drawings are used to provide a further understanding of the present invention, and constitute a part of the description, and are used together with the embodiments of the present invention to explain the present invention, and do not constitute a limitation to the present invention. In the attached picture:
图1是动脉覆膜支架结构示意图;Fig. 1 is a schematic diagram of the structure of an arterial stent graft;
图2是动脉瘤结构示意图;Figure 2 is a schematic diagram of the aneurysm structure;
图3是覆膜支架上纤毛的排列方式结构示意图;3 is a schematic diagram of the structure of the arrangement of cilia on the stent graft;
图4是覆膜支架上纤毛的缠绕与缝合结构示意图;Fig. 4 is a schematic diagram of the winding and suturing structure of the cilia on the stent graft;
图5是覆膜支架在胸主动脉动脉瘤的结构示意图;Fig. 5 is a structural schematic diagram of a covered stent in a thoracic aortic aneurysm;
图6是覆膜支架在腹主动脉动脉瘤的结构示意图;Fig. 6 is a schematic diagram of the structure of the covered stent in an abdominal aortic aneurysm;
图7是覆膜支架置入动脉瘤后,瘤颈处的截面图;Figure 7 is a cross-sectional view of the neck of the aneurysm after the covered stent is implanted;
图8是覆膜支架置入动脉瘤后,瘤体处的截面图。Fig. 8 is a cross-sectional view of the aneurysm after the covered stent is implanted.
具体实施方式detailed description
为使本发明的目的、技术方案和优点更加清楚,下面将结合实施例及附图对本发明作进一步详细的描述。In order to make the object, technical solution and advantages of the present invention clearer, the present invention will be further described in detail below in conjunction with the embodiments and accompanying drawings.
如图1所示,是动脉覆膜支架结构,所述覆膜支架包括覆膜支架段7和裸支架段6;所述覆膜支架段7包括波形环状金属丝3、覆膜4和纤毛5;As shown in Figure 1, it is an arterial stent-graft structure, and the stent-graft includes a stent-graft segment 7 and a bare stent segment 6; the stent-graft segment 7 includes a corrugated annular wire 3, a membrane 4 and cilia 5;
波形环状金属丝包括多圈,每圈沿覆膜的轴向依次分布;The corrugated annular wire includes multiple turns, and each turn is distributed sequentially along the axial direction of the film;
所述纤毛5附着于波形环状金属丝3上(如图3所示),且附着在覆膜支架段两端环形金属丝上的纤毛呈短而密状态分布;在覆膜支架段中间段的环形金属丝上的纤毛呈长而稀疏状态分布。The cilia 5 are attached to the corrugated annular wire 3 (as shown in Figure 3), and the cilia attached to the annular wire at both ends of the stent graft segment are distributed in a short and dense state; in the middle section of the stent graft segment The cilia on the circular wire are long and sparsely distributed.
上述附着在覆膜支架段7两端环形金属丝上的纤毛长度为4-6mm;所述附着在覆膜支架段7中间段的环形金属丝上的纤毛长度为10-15mm。The length of the cilia attached to the ring wire at both ends of the stent graft segment 7 is 4-6 mm; the length of the cilia attached to the ring wire at the middle section of the stent graft segment 7 is 10-15 mm.
上述纤毛5附着处边缘与所述覆膜支架段7的两端膜缘相距为5mm。The distance between the edge where the above-mentioned cilia 5 is attached and the edge of both ends of the stent-graft segment 7 is 5 mm.
上述附着于波形环状金属丝3上的纤毛5以缠绕的方式并通过固定件8固定于所述波形环状金属丝上(如图4所示)。The above-mentioned cilia 5 attached to the corrugated ring wire 3 are fixed on the corrugated ring wire 3 by a fixing member 8 in a winding manner (as shown in FIG. 4 ).
图2是动脉瘤结构示意图。Figure 2 is a schematic diagram of the aneurysm structure.
如图5和图6所示,分别为覆膜支架2在胸主动脉动脉瘤1和覆膜支架2在腹主动脉动脉瘤1的结构。As shown in FIG. 5 and FIG. 6 , the structures of the stent graft 2 in the thoracic aortic aneurysm 1 and the stent graft 2 in the abdominal aortic aneurysm 1 are respectively shown.
上述每圈波形环状金属丝沿覆膜的径向弹性张开,且多圈波形环状金属丝与覆膜一起形成一圆筒状弹性结构体。Each turn of the corrugated annular metal wire is stretched elastically along the radial direction of the coating, and multiple turns of the corrugated annular metal wire together with the coating form a cylindrical elastic structure.
上述覆膜支架下端与上端呈逐渐膨大的喇叭口型或直筒型,且覆膜支架中的裸支架段设置在所述覆膜支架段的上端。The lower end and the upper end of the stent-graft are in the shape of a gradually expanding bell mouth or a straight cylinder, and the bare stent segment in the stent-graft is arranged at the upper end of the stent-graft segment.
如图7和图8所示,分别为覆膜支架2置入动脉瘤1后,瘤颈处的截面图;和覆膜支架置入动脉瘤1后,瘤体处的截面图。As shown in FIG. 7 and FIG. 8 , they are respectively a cross-sectional view at the neck of the aneurysm after the stent graft 2 is implanted in the aneurysm 1 ; and a cross-sectional view at the tumor body after the stent-graft is implanted in the aneurysm 1 .
上述纤毛由生物相容性良好且容易吸附血小板和凝血物质的高分子材料制成,包括但不限于Nylon(不可吸收)、PGLA(含90%聚乙醇酸交酯和10%聚乙醇酸,可吸收)等。The above-mentioned cilia are made of polymer materials with good biocompatibility and easy adsorption of platelets and coagulation substances, including but not limited to Nylon (non-absorbable), PGLA (containing 90% polyglycolide and 10% polyglycolic acid, which can absorption), etc.
上述覆膜由具有良好生物相容性的高分子材料制成,包括但不限于聚氨基甲酸乙酯、聚四氟乙烯、聚酯、涤纶等,用以隔绝动脉瘤,保证血流沿着动脉的方向向远端流去。The above-mentioned covering film is made of high-molecular materials with good biocompatibility, including but not limited to polyurethane, polytetrafluoroethylene, polyester, polyester, etc., to isolate the aneurysm and ensure blood flow along the artery direction to the far end.
在覆膜支架段的近端裸支架段设有防脱固定件,该固定件可以是倒刺、倒钩等,可在支架打开后抵抗血流的冲击,将覆膜支架固定于主动脉壁上。The proximal bare stent section of the covered stent section is provided with an anti-off fixing piece, which can be barbs, barbs, etc., which can resist the impact of blood flow after the stent is opened, and fix the covered stent on the aortic wall superior.
上述波形环状金属丝由具有弹性的合金材料制成,包括但不限于不锈钢、记忆合金等材料。The above-mentioned corrugated ring wire is made of elastic alloy material, including but not limited to stainless steel, memory alloy and other materials.
虽然本发明所揭露的实施方式如上,但所述的内容只是为了便于理解本发明而采用的实施方式,并非用以限定本发明。任何本发明所属技术领域内的技术人员,在不脱离本发明所揭露的精神和范围的前提下,可以在实施的形式上及细节上作任何的修改与变化,但本发明的专利保护范围,仍须以所附的权利要求书所界定的范围为准。Although the embodiments disclosed in the present invention are as above, the described content is only an embodiment adopted for the convenience of understanding the present invention, and is not intended to limit the present invention. Anyone skilled in the technical field to which the present invention belongs can make any modifications and changes in the form and details of the implementation without departing from the spirit and scope disclosed by the present invention, but the patent protection scope of the present invention, The scope defined by the appended claims must still prevail.
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