CN104758023B - A kind of blood flow turning rack - Google Patents
A kind of blood flow turning rack Download PDFInfo
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- CN104758023B CN104758023B CN201510190933.6A CN201510190933A CN104758023B CN 104758023 B CN104758023 B CN 104758023B CN 201510190933 A CN201510190933 A CN 201510190933A CN 104758023 B CN104758023 B CN 104758023B
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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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
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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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2002/823—Stents, different from stent-grafts, adapted to cover an aneurysm
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Abstract
本发明提供一种血流转向支架,包括:网状镂空的圆筒形支撑架和设置于所述支撑架内壁上的转向装置;所述转向装置由在所述支撑架径向上均匀分布、沿所述支撑架的轴向依次排列的多个转向片构成。本发明利用转向片,改变血流方向,使动脉瘤内的血液流动减弱,减轻血流冲击对瘤壁造成的损伤,从而防止动脉瘤继续增大或破裂,甚至可以使动脉瘤完全退化或消失。同时,本发明的支架为镂空结构,并且其中设置有转向片,可以改变血流方向,避免了覆膜,血流可以流入侧枝血管,避免了侧枝血管的堵塞。
The present invention provides a blood flow diverting bracket, comprising: a mesh hollow cylindrical support frame and a steering device arranged on the inner wall of the support frame; the steering device is uniformly distributed in the radial direction of the support frame, The support frame is composed of a plurality of turning pieces arranged in sequence in the axial direction. The present invention uses the diverting piece to change the direction of blood flow, weakens the blood flow in the aneurysm, and reduces the damage caused by the impact of blood flow on the aneurysm wall, thereby preventing the aneurysm from continuing to grow or rupture, and even completely degrading or disappearing the aneurysm . At the same time, the stent of the present invention is a hollow structure, and a turning plate is arranged therein, which can change the direction of blood flow, avoid covering membrane, allow blood flow to flow into side branch vessels, and avoid blockage of side branch vessels.
Description
技术领域technical field
本发明涉及医疗器械领域,特别涉及一种血流转向支架。The invention relates to the field of medical instruments, in particular to a blood flow steering bracket.
背景技术Background technique
动脉瘤是由于动脉壁的病变或损伤,形成动脉壁局限性或弥漫性扩张或膨出的表现,以膨胀性、搏动性肿块为主要表现。动脉瘤是一种具有潜在生命危险的疾病,其在血流的冲击下不断生长,压迫周围气管或组织而引起症状,如:由于血压增高或其他因素引起的动脉瘤破裂,就会发生急剧的出血。动脉瘤可以发生在动脉系统的任何部位,而以肢体主干动脉瘤、颅内动脉瘤和颈动脉瘤较为常见。其中以颅内动脉瘤的治疗最为复杂。Aneurysm is a manifestation of localized or diffuse expansion or bulging of the arterial wall due to lesion or injury of the arterial wall, and the main manifestation is an expansive and pulsating mass. Aneurysm is a potentially life-threatening disease, which continues to grow under the impact of blood flow, compressing the surrounding trachea or tissue and causing symptoms, such as: aneurysm rupture due to increased blood pressure or other factors, will occur sharply bleeding. Aneurysms can occur anywhere in the arterial system, but trunk aneurysms, intracranial aneurysms, and carotid aneurysms are more common. Among them, the treatment of intracranial aneurysms is the most complicated.
颅内动脉瘤是由于脑动脉管壁局部的先天性缺陷和脑动脉腔内压力增高引起的。其破裂时,表现为剧烈头痛、烦躁、恶心呕吐等脑膜刺激症,随之会出现颅内压增高,病情严重时,可危及生命。Intracranial aneurysms are caused by localized congenital defects in the walls of cerebral arteries and increased intracranial pressure. When it ruptures, it manifests as meningeal irritation such as severe headache, irritability, nausea and vomiting, followed by increased intracranial pressure, which can be life-threatening in severe cases.
颅内动脉瘤的经血管内治疗方法主要是载瘤动脉闭塞、动脉瘤腔内的球囊栓塞、液体栓塞、弹簧圈栓塞以及血管组织工程技术。应用最多的是电解脱弹簧圈(GDC)栓塞技术,通过在动脉瘤腔内填塞弹簧圈,或者在球囊/支架的帮助下填塞动脉瘤腔,使瘤腔内形成血栓,最终与正常血液隔离。采用上述手段治疗后,颅内巨大动脉瘤会产生占位效应,或者出现瘤腔内无法致密填塞等情况,导致这些技术都很难获得理想的治疗效果。Endovascular treatment methods for intracranial aneurysms mainly include parent artery occlusion, balloon embolization in the aneurysm cavity, liquid embolization, coil embolization, and vascular tissue engineering techniques. The electrolytic decoil coil (GDC) embolization technique is the most widely used, by stuffing a coil in the aneurysm cavity, or filling the aneurysm cavity with the help of a balloon/stent, so that a thrombus is formed in the aneurysm cavity, and finally isolated from normal blood . After the treatment with the above methods, the huge intracranial aneurysm will produce a mass effect, or the aneurysm cavity will not be densely packed, making it difficult for these techniques to obtain ideal therapeutic effects.
随后,覆膜支架逐渐成为治疗动脉瘤的新方式,现有的覆膜支架包括支撑结构和覆膜,覆膜包覆在支撑结构的外部,通过覆膜的物理隔绝作用,将动脉瘤病变部位的血流与正常学循环隔绝,在载瘤动脉内重新建立血流通道。但是该种覆膜支架会引起支架段侧支血管的堵塞,或者支架植入后的再狭窄。Subsequently, the covered stent gradually became a new way to treat aneurysms. The existing covered stent includes a support structure and a membrane. The membrane covers the outside of the support structure. The blood flow of the tumor is isolated from the normal circulation, and the blood flow channel is re-established in the parent artery. However, this kind of covered stent may cause blockage of side branch vessels of the stent segment, or restenosis after stent implantation.
发明内容Contents of the invention
本发明解决的技术问题在于提供一种血流转向支架,其可以改变血流方向,避免血流冲击动脉瘤内腔,防止动脉瘤继续增大或破裂,甚至可以使动脉瘤完全退化或消失,达到治愈颅内动脉瘤的目的;同时,其还可以避免侧支血管的堵塞。The technical problem to be solved by the present invention is to provide a blood flow steering stent, which can change the direction of blood flow, prevent the blood flow from impacting the inner cavity of the aneurysm, prevent the aneurysm from continuing to grow or rupture, and even completely degenerate or disappear the aneurysm. To achieve the purpose of curing intracranial aneurysms; at the same time, it can also avoid the blockage of collateral vessels.
本发明公开了一种血流转向支架,包括:The invention discloses a blood flow steering bracket, comprising:
网状镂空的圆筒形支撑架和设置于所述支撑架内壁上的转向装置;A mesh-shaped hollow cylindrical support frame and a steering device arranged on the inner wall of the support frame;
所述转向装置由在所述支撑架径向上均匀分布、沿所述支撑架的轴向依次排列的多个转向片构成。The steering device is composed of a plurality of steering blades that are evenly distributed in the radial direction of the support frame and arranged in sequence along the axial direction of the support frame.
优选的,还包括:设置于所述转向装置两端的示标。Preferably, it also includes: markings arranged at both ends of the steering device.
优选的,还包括设置于所述支撑架两端的示标。Preferably, it also includes markings arranged at both ends of the support frame.
优选的,所述转向装置的长度为5~16mm。Preferably, the length of the steering device is 5-16 mm.
优选的,所述转向片表面与支撑架内壁表面呈1~30°角。Preferably, the surface of the turning plate and the inner wall surface of the support frame form an angle of 1-30°.
优选的,所述转向片与所述支撑架通过连接点接触连接,所述转向片以其与所述支撑架的连接点为中心旋转0~45°夹角。Preferably, the turning piece is connected to the support frame through a connection point, and the turning piece is rotated at an angle of 0-45° around the connection point between the turning piece and the support frame.
优选的,所述转向装置两端的支撑架长度相等。Preferably, the lengths of the support frames at both ends of the steering device are equal.
优选的,所述支撑架的直径为2~10mm。Preferably, the diameter of the support frame is 2-10mm.
优选的,所述转向片为边缘光滑的薄片。Preferably, the diverting sheet is a thin sheet with smooth edges.
优选的,所述转向片沿轴向的数量为6~20排,同一圆周上的转向片数量为6~50个。Preferably, the number of the turning vanes along the axial direction is 6-20 rows, and the number of turning vanes on the same circumference is 6-50.
与现有技术相比,本发明的血流转向支架,包括:网状镂空的圆筒形支撑架和设置于所述支撑架内壁上的转向装置;所述转向装置由在所述支撑架径向上均匀分布、沿所述支撑架的轴向依次排列的多个转向片构成。本发明利用转向片,改变血流方向,使动脉瘤内的血液流动减弱,减轻血流冲击对瘤壁造成的损伤,从而防止动脉瘤继续增大或破裂,甚至可以使动脉瘤完全退化或消失。同时,本发明的支架为镂空结构,并且其中设置有转向片,可以改变血流方向,避免了覆膜,血流可以流入侧枝血管,避免了侧枝血管的堵塞。Compared with the prior art, the blood flow steering bracket of the present invention includes: a mesh hollow cylindrical support frame and a steering device arranged on the inner wall of the support frame; It is composed of a plurality of turning blades that are evenly distributed upwards and arranged in sequence along the axial direction of the support frame. The present invention uses the diverting piece to change the direction of blood flow, weakens the blood flow in the aneurysm, and reduces the damage caused by the impact of blood flow on the aneurysm wall, thereby preventing the aneurysm from continuing to grow or rupture, and even completely degrading or disappearing the aneurysm . At the same time, the stent of the present invention is a hollow structure, and a turning plate is arranged therein, which can change the direction of blood flow, avoid covering membrane, allow blood flow to flow into side branch vessels, and avoid blockage of side branch vessels.
附图说明Description of drawings
图1为本发明血流转向支架的内部剖面结构示意图;Fig. 1 is a schematic diagram of the internal cross-sectional structure of the blood flow steering bracket of the present invention;
图2为本发明的转向片呈不同扭转角度时的侧面结构示意图;Fig. 2 is a schematic view of the side structure when the diverter blade of the present invention is at different torsion angles;
图3为本发明血流转向支架释放于血管内的示意图。Fig. 3 is a schematic diagram of the blood flow diverting stent of the present invention being released in a blood vessel.
具体实施方式detailed description
为了进一步理解本发明,下面结合实施例对本发明优选实施方案进行描述,但是应当理解,这些描述只是为进一步说明本发明的特征和优点,而不是对本发明权利要求的限制。In order to further understand the present invention, the preferred embodiments of the present invention are described below in conjunction with examples, but it should be understood that these descriptions are only to further illustrate the features and advantages of the present invention, rather than limiting the claims of the present invention.
本发明实施例公开了一种血流转向支架,包括:The embodiment of the present invention discloses a blood flow diversion stent, including:
网状镂空的圆筒形支撑架和设置于所述支撑架内壁上的转向装置;A mesh-shaped hollow cylindrical support frame and a steering device arranged on the inner wall of the support frame;
所述转向装置由在所述支撑架径向上均匀分布、延所述支撑架的轴向依次排列的多个转向片构成。The steering device is composed of a plurality of steering blades that are evenly distributed in the radial direction of the support frame and arranged in sequence along the axial direction of the support frame.
本发明的血流转向支架包括支撑架和转向装置。所述支撑架为网状镂空的圆筒形,其两端开放,优选为自膨式金属支架。所述支撑架优选采用记忆金属制成,更优选为镍钛合金;所述支撑架的外径优选为1~5mm,壁厚优选为0.1~0.25mm,长度优选为10~20mm。为了所述支架可以准确作用于动脉瘤的位置,优选的,还包括设置于所述支撑架两端的示标。所述示标优选为直径为0.01~0.06mm的铂金丝、铂合金丝、黄金丝或黄金合金丝。所述示标在X光下可以显示支架的位置,便于准确定位。The blood flow steering bracket of the present invention includes a support frame and a steering device. The support frame is a mesh-shaped hollow cylinder with open ends, and is preferably a self-expanding metal support. The support frame is preferably made of memory metal, more preferably nickel-titanium alloy; the outer diameter of the support frame is preferably 1-5 mm, the wall thickness is preferably 0.1-0.25 mm, and the length is preferably 10-20 mm. In order that the stent can accurately act on the position of the aneurysm, it preferably also includes markings arranged at both ends of the stent. The indicator is preferably platinum wire, platinum alloy wire, gold wire or gold alloy wire with a diameter of 0.01-0.06 mm. The indicator can show the position of the bracket under X-ray, which is convenient for accurate positioning.
在本发明中,所述转向装置由在所述支撑架径向上均匀分布、延所述支撑架的轴向依次排列的多个转向片构成。所述转向装置设置于所述支撑架内壁上,其可以设置于支撑架内壁的任意部位,可以靠近支撑架的端部,也可以在支撑架的中部;优选的所述转向装置两端的支撑架长度相等,即所述转向装置设置于所述支撑架内壁的中间部位。所述转向装置的长度优选为5~16mm。在血管内,所述转向装置需要精准放置于动脉瘤的开口处,因此,本发明的血流转向支架优选的还包括设置于所述转向装置两端的示标。所述示标优选为直径为0.01~0.06mm的铂金丝、铂合金丝、黄金丝或黄金合金丝。所述示标在X光下可以显示转向装置的位置,便于准确定位。In the present invention, the steering device is composed of a plurality of steering blades that are evenly distributed in the radial direction of the support frame and arranged in sequence along the axial direction of the support frame. The steering device is arranged on the inner wall of the support frame, which can be arranged on any part of the inner wall of the support frame, can be close to the end of the support frame, or can be in the middle of the support frame; preferably the support frames at both ends of the steering device The lengths are equal, that is, the steering device is arranged at the middle part of the inner wall of the support frame. The length of the steering device is preferably 5-16 mm. In the blood vessel, the steering device needs to be accurately placed at the opening of the aneurysm. Therefore, the blood flow diverting stent of the present invention preferably further includes indicators arranged at both ends of the steering device. The indicator is preferably platinum wire, platinum alloy wire, gold wire or gold alloy wire with a diameter of 0.01-0.06 mm. The indicator can display the position of the steering device under X-ray, which is convenient for accurate positioning.
所述转向片优选为边缘光滑的薄片,对于所述转向片的形状没有特殊限制,可以为圆形、椭圆形或鳞片形等,所述转向片优选的宽为0.1~3mm,长为1~5mm,厚度为0.1~0.25mm。所述转向片与支撑架通过连接点接触连接,优选的,所述转向片表面与支撑架内壁表面呈1~30°角。进一步优选的,所述转向片以其与所述支撑架的连接点为中心旋转0~45°夹角。所述转向片沿轴向的数量优选为6~20排,同一圆周上的转向片数量优选为6~50个。本发明通过转向片的作用,改变血流方向,使瘤内血液流动减弱,减轻血流冲击对瘤壁造成的损伤,使瘤内迅速形成血栓。The diverter vane is preferably a thin sheet with smooth edges. There is no special limitation on the shape of the diverter vane, which can be circular, oval or scale-shaped. The preferred width of the diverter vane is 0.1-3mm, and the length is 1-3 mm. 5mm, thickness 0.1 ~ 0.25mm. The turning piece is connected to the support frame through a connection point. Preferably, the surface of the turning piece and the inner wall surface of the support frame form an angle of 1-30°. Further preferably, the turning piece rotates at an angle of 0-45° around its connection point with the support frame. The number of the diverting vanes along the axial direction is preferably 6-20 rows, and the number of diverting vanes on the same circumference is preferably 6-50. The invention changes the direction of the blood flow through the function of the turning plate, weakens the blood flow in the tumor, reduces the damage to the tumor wall caused by the impact of the blood flow, and rapidly forms a thrombus in the tumor.
由于本发明的血流转向支架整体属于镂空结构,因此在具有侧枝血管时,血流仍然可以顺利缓慢流入侧枝血管,避免了侧枝血管被封堵的情况。Since the blood flow steering stent of the present invention has a hollow structure as a whole, when there are side branch vessels, the blood flow can still smoothly and slowly flow into the side branch vessels, avoiding the situation that the side branch vessels are blocked.
图1为本发明血流转向支架的内部剖面结构示意图。图1中,(1)为支撑架示标,(2)为转向装置示标,(3)为转向装置,(4)为支撑架。Fig. 1 is a schematic diagram of the internal cross-sectional structure of the blood flow diverting stent of the present invention. In Fig. 1, (1) is the support frame mark, (2) is the steering device mark, (3) is the steering device, and (4) is the support frame.
图2为本发明的转向片呈不同扭转角度时的侧面结构示意图。图2中,转向片(3)突出与支撑架表面并旋转呈角度。2a为转向片表面与支撑架内壁表面呈1~30°角时的侧面结构示意图;2b为转向片表面与支撑架内壁表面呈1~30°角,并且所述转向片以其与所述支撑架的连接点为中心旋转大于0°小于等于45°夹角时的侧面结构示意图。Fig. 2 is a schematic view of the side structure of the diverter blade of the present invention when it is twisted at different angles. In Fig. 2, the steering piece (3) protrudes from the surface of the support frame and rotates at an angle. 2a is a schematic diagram of the side structure when the surface of the steering plate and the inner wall surface of the support frame form an angle of 1 to 30°; Schematic diagram of the side structure when the connection point of the frame is rotated from the center to an angle greater than 0° and less than or equal to 45°.
图3为本发明血流转向支架释放于血管内的示意图。图3中,将血流转向支架(8)释放于血管(5)内,转向装置(3)横跨动脉瘤颈,当血液(7)流经动脉瘤(6)时,转向装置(3)的转向片具有阻挡租用,血流原本的流动方向被改变,无法直接充入动脉瘤腔,防止动脉瘤继续增大或破裂。而且,由于本发明的血流转向支架采用镂空结构,对于支架置入部位有侧枝(9)的情况,血流仍然可以顺利缓慢流入侧枝血管,避免了侧枝(9)被封堵。Fig. 3 is a schematic diagram of the blood flow diverting stent of the present invention being released in a blood vessel. In Fig. 3, the blood flow steering stent (8) is released in the blood vessel (5), and the steering device (3) spans the neck of the aneurysm. When the blood (7) flows through the aneurysm (6), the steering device (3) The steering piece has a blocking function, the original flow direction of the blood flow is changed, and it cannot be directly filled into the aneurysm cavity, preventing the aneurysm from continuing to grow or rupture. Moreover, since the blood flow steering stent of the present invention adopts a hollow structure, when there are side branches (9) at the place where the stent is placed, the blood flow can still smoothly and slowly flow into the side branch vessels, avoiding the side branches (9) from being blocked.
本发明的血流转向支架的制备方法为:The preparation method of the blood flow steering bracket of the present invention is as follows:
采用激光切割记忆合金管或者编织记忆合金丝,得到网状镂空的圆筒形支撑架;Use laser cutting memory alloy tube or weaving memory alloy wire to get a mesh hollow cylindrical support frame;
将记忆合金材料制成的转向片装配在所述支撑架上,得到血流转向支架。A diverting piece made of memory alloy material is assembled on the support frame to obtain a blood flow diverting bracket.
以上实施例的说明只是用于帮助理解本发明的方法及其核心思想。应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以对本发明进行若干改进和修饰,这些改进和修饰也落入本发明权利要求的保护范围内。The descriptions of the above embodiments are only used to help understand the method and core idea of the present invention. It should be pointed out that for those skilled in the art, without departing from the principles of the present invention, some improvements and modifications can be made to the present invention, and these improvements and modifications also fall within the protection scope of the claims of the present invention.
对所公开的实施例的上述说明,使本领域专业技术人员能够实现或使用本发明。对这些实施例的多种修改对本领域的专业技术人员来说将是显而易见的,本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下,在其它实施例中实现。因此,本发明将不会被限制于本文所示的这些实施例,而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。The above description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention will not be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
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