CN108261254A - Branch type overlay film frame - Google Patents
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- CN108261254A CN108261254A CN201611267438.1A CN201611267438A CN108261254A CN 108261254 A CN108261254 A CN 108261254A CN 201611267438 A CN201611267438 A CN 201611267438A CN 108261254 A CN108261254 A CN 108261254A
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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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Abstract
一种分叉型覆膜支架,包括管状主体及与管状主体连通的侧分支,管状主体包括第一裸支架及设于第一裸支架的第一覆膜,第一裸支架包括至少一个非端部波形环状物,侧分支包括第二覆膜,第二覆膜与第一覆膜连接,第一覆膜与第二覆膜的接口处设置有沿接口外周分布的膨胀环,且膨胀环至少部分位于管状主体设置有非端部波形环状物的圆周面上。上述分叉型覆膜支架,通过在接口处设置膨胀环,且膨胀环至少部分位于管状主体设置有非端部波形环状物的圆周面上,支架释放后,膨胀环能够随着第一裸支架的自膨胀而径向扩展,以保持接口处的径向宽度,从而保证血流顺利地从管状主体内通过接口流进侧分支,使侧分支内血流通畅、充足,且易于导丝进入。
A bifurcated covered stent, comprising a tubular main body and side branches communicating with the tubular main body, the tubular main body includes a first bare stent and a first membrane disposed on the first bare stent, the first bare stent includes at least one non-end The side branch includes a second coating, the second coating is connected to the first coating, and the interface between the first coating and the second coating is provided with an expansion ring distributed along the periphery of the interface, and the expansion ring At least partly on the circumferential surface of the tubular body provided with the non-end wave-shaped ring. The aforementioned bifurcated stent graft is provided with an expansion ring at the interface, and the expansion ring is at least partially located on the circumferential surface of the tubular body provided with a non-end wave-shaped ring. After the stent is released, the expansion ring can follow the first bare The self-expansion of the stent expands radially to maintain the radial width of the interface, so as to ensure that the blood flow smoothly flows from the tubular body through the interface into the side branch, so that the blood flow in the side branch is smooth and sufficient, and it is easy for the guide wire to enter .
Description
技术领域technical field
本发明涉及医疗器械技术领域,特别是涉及一种分叉型覆膜支架。The invention relates to the technical field of medical devices, in particular to a bifurcated covered stent graft.
背景技术Background technique
动脉瘤是临床上常见的血管疾病,多发生在老年人身上,这种疾病容易导致主动脉瘤破裂,对患者的生命造成极大的威胁,一般的外科手术曾被认为是治疗主动脉瘤的唯一方式,但该方法手术危险性极大。Aneurysm is a clinically common vascular disease, which mostly occurs in the elderly. This disease can easily lead to aortic aneurysm rupture, which poses a great threat to the life of patients. General surgery was once considered the only way to treat aortic aneurysm. The only way, but this method is extremely dangerous.
随着现在医学技术的不断发展,利用微创手术将覆膜支架植入人体内,治疗主动脉瘤及夹层动脉瘤的治疗手术正在被越来越多的利用。这种治疗方法将人造的覆膜支架压缩进输送装置,沿着事先植入的导丝引导进入人体,将覆膜支架释放到病变位置,隔绝瘤腔形成新的血流通道,动脉瘤在丧失血流供应后,瘤腔内残存血液逐渐血栓并肌化成血管组织,扩张状态的瘤壁因受负压而收缩,逐渐恢复到接近原始状态,从而达到治疗动脉瘤的目的。With the continuous development of medical technology, the use of minimally invasive surgery to implant covered stents into the human body to treat aortic aneurysms and dissecting aneurysms is being used more and more. This treatment method compresses the artificial covered stent into the delivery device, guides it into the human body along the previously implanted guide wire, releases the covered stent to the lesion, isolates the aneurysm cavity and forms a new blood flow channel, and the aneurysm is lost. After the blood supply, the remaining blood in the aneurysm gradually thrombuses and muscularizes into vascular tissue, and the expanded aneurysm wall shrinks due to negative pressure, and gradually returns to its original state, thereby achieving the purpose of treating the aneurysm.
然而,人体的血管结构复杂,且侧分支较多,同时患者个体差异较大,瘤体的长度可能很长,瘤体的位置差别也可能较大,临床上瘤体位于侧分支血管处或侧分支附近的情况也比较常见,若采用覆膜支架治疗动脉瘤,往往会闭塞掉侧分支血管。标准化的直管型覆膜支架很难满足要求,往往需要针对特殊的血管部位定制侧分支血管。However, the vascular structure of the human body is complex, and there are many side branches. At the same time, individual patients are different. The length of the tumor may be very long, and the location of the tumor may also vary greatly. The situation near the branch is also more common. If the aneurysm is treated with a covered stent, the side branch blood vessel will often be occluded. Standardized straight-tube stent-grafts are difficult to meet the requirements, and side branch vessels often need to be customized for special vascular sites.
目前出现了分叉型覆膜支架,可根据患者动脉瘤的位置和形态制定侧分支和主体的不同规格,临床应用较为广泛。但这会带来新的问题,例如,支架的侧分支和主体连接处的覆膜连接口,因为覆膜一般为柔性材料,无支撑力,因此自身无法保持接口的形态,造成接口位置呈现扁缝状,不利于血流通过接口处。一般地,主体和侧分支之间的金属支架和覆膜的结构主要有两种,一是通过横跨主体和侧分支的金属波圈,其次就是主体和侧分支分别采用独立的金属波圈。这两种方式,前者主体和侧分支金属支架连成一体可以保证侧分支的接口形态,但是一体式的金属支架结构限制了侧分支和主体之间的柔顺性,后者主体和侧分支支架分别独立的金属支架结构,虽然侧分支和主体之间有较好的柔顺性,但侧分支接口位置没有金属支架的支撑,其接口形态不好,影响后续手术导丝通过主体支架进入侧分支支架建立轨道的过程,并且也不利于血流的通过。At present, a bifurcated stent graft has appeared, and different specifications of side branches and main body can be made according to the position and shape of the patient's aneurysm, and it is widely used in clinical practice. But this will bring new problems, for example, the side branch of the stent and the film connection port at the junction of the main body, because the film is generally a flexible material and has no supporting force, so it cannot maintain the shape of the interface itself, resulting in a flat position of the interface. Seams are not conducive to blood flow through the interface. Generally, there are two main structures of the metal bracket and the membrane between the main body and the side branches, one is through the metal corrugated across the main body and the side branches, and the other is that the main body and the side branches use independent metal corrugations. In the two ways, the former main body and the side branch metal bracket are integrated to ensure the interface shape of the side branch, but the integrated metal bracket structure limits the flexibility between the side branch and the main body, and the latter main body and the side branch bracket are separated. Independent metal stent structure, although there is good flexibility between the side branch and the main body, but the position of the side branch interface is not supported by the metal stent, and the interface shape is not good, which affects the subsequent surgical guide wire entering the side branch stent through the main body stent. Orbital process, and is also not conducive to the passage of blood flow.
发明内容Contents of the invention
基于此,针对上述问题,有必要提供一种分叉型覆膜支架,以提高侧分支接口处的轮廓形态,使侧分支血流通畅。Based on this, in view of the above problems, it is necessary to provide a bifurcated stent-graft to improve the contour shape of the side branch interface and make the blood flow of the side branch unobstructed.
一种分叉型覆膜支架,包括管状主体及与所述管状主体连通的侧分支,所述管状主体包括第一裸支架及设于所述第一裸支架的第一覆膜,所述第一裸支架包括至少一个非端部波形环状物,所述侧分支包括第二覆膜,所述第二覆膜与所述第一覆膜连接,所述第一覆膜与所述第二覆膜的接口处设置有沿所述接口外周分布的膨胀环,且所述膨胀环至少部分位于所述管状主体设置有所述非端部波形环状物的圆周面上。A bifurcated covered stent comprising a tubular main body and side branches communicating with the tubular main body, the tubular main body includes a first bare stent and a first membrane disposed on the first bare stent, the first A bare stent comprising at least one non-terminal undulating annulus, the side branches comprising a second covering connected to the first covering, the first covering connected to the second covering The interface of the coating is provided with expansion rings distributed along the outer periphery of the interface, and the expansion rings are at least partially located on the circumferential surface of the tubular body provided with the non-end wave-shaped ring.
在其中一个实施例中,所述第一裸支架还包括近端波形环状物及远端波形环状物,所述至少一个非端部波形环状物设置于所述近端波形环状物与所述远端波形环状物之间,所述非端部波形环状物为开口环,所述膨胀环至少部分位于所述非端部波形环状物的开口处。In one of the embodiments, the first bare stent further includes a proximal wave-shaped ring and a distal wave-shaped ring, and the at least one non-end wave-shaped ring is arranged on the proximal wave-shaped ring Between the distal wave-shaped ring, the non-end wave-shaped ring is an open ring, and the expansion ring is at least partially located at the opening of the non-end wave-shaped ring.
在其中一个实施例中,所述膨胀环与所述非端部波形环状物的自由端相连。In one of the embodiments, the expandable ring is connected to the free end of the non-end wave-shaped ring.
在其中一个实施例中,所述非端部波形环状物的个数至少为两个,所述膨胀环与至少两个所述非端部波形环状物的所有自由端均相连。In one embodiment, there are at least two non-end wave-shaped rings, and the expansion ring is connected to all free ends of the at least two non-end wave-shaped rings.
在其中一个实施例中,所述膨胀环包括金属丝绕所述接口外周环绕形成的膨胀部及与所述膨胀部连接的活动部,所述膨胀部至少部分位于所述非端部波形环状物的圆周面上。In one of the embodiments, the expansion ring includes an expansion part formed by a metal wire around the periphery of the interface and a movable part connected with the expansion part, and the expansion part is at least partly located in the non-end wave-shaped ring on the circumference of the object.
在其中一个实施例中,所述膨胀环具有靠近所述近端波形环状物的最高点及靠近所述远端波形环状物的最低点,所述活动部位于所述最低点与所述最高点的连线的一侧。In one of the embodiments, the expandable ring has a highest point close to the proximal wave-shaped ring and a lowest point close to the distal wave-shaped ring, and the movable part is located between the lowest point and the The side of the line connecting the highest points.
在其中一个实施例中,所述活动部两端点之间的连线与所述膨胀环的所述最低点与所述最高点之间的连线平行。In one embodiment, the line between the two ends of the movable part is parallel to the line between the lowest point and the highest point of the expansion ring.
在其中一个实施例中,所述活动部为设置于所述膨胀环上的缺口。In one of the embodiments, the movable part is a notch provided on the expansion ring.
在其中一个实施例中,所述缺口为两个,两个所述缺口将所述膨胀环切割成两个沿所述管状主体的纵向中心轴线方向排列的所述膨胀部,每一所述膨胀部的两端分别与一个所述非端部波形环状物两对应的自由端连接。In one of the embodiments, there are two gaps, and the two gaps cut the expansion ring into two expansion parts arranged along the longitudinal central axis of the tubular body, each of the expansion The two ends of the portion are respectively connected to two corresponding free ends of the non-end wave-shaped ring.
在其中一个实施例中,所述膨胀部为开环结构,所述膨胀部相对的两个端部彼此先相互靠近再相互远离地延伸形成重叠区域,所述成叠区域即形成所述活动部。In one embodiment, the expansion part is an open-loop structure, and the two opposite ends of the expansion part first approach each other and then extend away from each other to form an overlapping area, and the stacked area forms the movable part .
在其中一个实施例中,所述活动部的末端呈圆滑状。In one of the embodiments, the end of the movable part is round and smooth.
在其中一个实施例中,所述活动部为设置于所述膨胀环上的波形段,所述波形段包括若干个波形。In one of the embodiments, the movable part is a wave section provided on the expansion ring, and the wave section includes several waves.
在其中一个实施例中,所述波形段的个数为两个,两个所述波形段对称设置。In one of the embodiments, the number of the waveform segments is two, and the two waveform segments are arranged symmetrically.
在其中一个实施例中,所述波形为M形波、Z形波或正弦波中的至少一种。In one of the embodiments, the waveform is at least one of M-shaped wave, Z-shaped wave or sine wave.
在其中一个实施例中,所述管状主体的纵向中心轴线与所述侧分支的纵向中心轴线之间的夹角为锐角,所述膨胀环呈椭圆形。In one embodiment, the angle between the longitudinal central axis of the tubular body and the longitudinal central axis of the side branch is an acute angle, and the expansion ring is elliptical.
上述分叉型覆膜支架,通过在接口处设置膨胀环,且所述膨胀环至少部分位于所述管状主体设置有所述非端部波形环状物的圆周面上,膨胀环为接口提供支撑力,支架释放后,膨胀环能够随着第一裸支架的自膨胀而径向扩展,以保持接口处的径向宽度,从而保证血流顺利地从管状主体内通过接口流进侧分支,使侧分支内血流通畅、充足,且易于导丝进入。同时,管状主体与侧分支可以采用相互独立的裸支架,可以提高侧分支与主体之间的柔顺性,提高了支架的适应性。In the aforementioned bifurcated stent-graft, an expansion ring is provided at the interface, and the expansion ring is at least partially located on the circumferential surface of the tubular body provided with the non-end wave-shaped ring, and the expansion ring provides support for the interface. After the stent is released, the expansion ring can radially expand with the self-expansion of the first bare stent to maintain the radial width of the interface, so as to ensure that the blood flow smoothly flows from the tubular main body through the interface into the side branch, so that The blood flow in the side branches is smooth and sufficient, and the guide wire is easy to enter. At the same time, the tubular main body and the side branches can use independent bare stents, which can improve the flexibility between the side branches and the main body, and improve the adaptability of the stent.
附图说明Description of drawings
图1为本发明一实施例的分叉型覆膜支架的结构示意图;FIG. 1 is a schematic structural view of a bifurcated stent graft according to an embodiment of the present invention;
图2为图1所示的分叉型覆膜支架另一视角的结构示意图;Fig. 2 is a structural schematic view of another perspective of the bifurcated stent graft shown in Fig. 1;
图3为本发明另一实施例的分叉型覆膜支架的膨胀环与非端部波形环状物的结构示意图;3 is a schematic structural view of the expansion ring and the non-end wave ring of the bifurcated stent graft according to another embodiment of the present invention;
图4为本发明又一实施例的分叉型覆膜支架的膨胀环与非端部波形环状物的结构示意图;Fig. 4 is a structural schematic diagram of an expansion ring and a non-end wave ring of a bifurcated stent graft according to another embodiment of the present invention;
图5为本发明再一实施例的分叉型覆膜支架的膨胀环与非端部波形环状物的结构示意图;5 is a schematic structural view of the expansion ring and the non-end wave ring of the bifurcated stent graft according to another embodiment of the present invention;
图6为本发明又一实施例的分叉型覆膜支架的膨胀环的结构示意图;Fig. 6 is a structural schematic diagram of an expansion ring of a bifurcated stent graft according to another embodiment of the present invention;
图7为本发明另一实施例的分叉型覆膜支架的膨胀环的结构示意图。Fig. 7 is a schematic structural view of an expansion ring of a bifurcated stent graft according to another embodiment of the present invention.
具体实施方式Detailed ways
为使本发明的上述目的、特征和优点能够更加明显易懂,下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施,本领域技术人员可以在不违背本发明内涵的情况下做类似改进,因此本发明不受下面公开的具体实施的限制。In order to make the above objects, features and advantages of the present invention more comprehensible, specific implementations of the present invention will be described in detail below in conjunction with the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, the present invention can be implemented in many other ways different from those described here, and those skilled in the art can make similar improvements without departing from the connotation of the present invention, so the present invention is not limited by the specific implementations disclosed below.
需要说明的是,当元件被称为“固定于”或“设置于”另一个元件,它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件,它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明的目的,并不表示是唯一的实施方式。It should be noted that when an element is referred to as being “fixed on” or “disposed on” another element, it may be directly on the other element or there may be an intervening element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "left," "right," and similar expressions are used herein for purposes of illustration only and are not intended to represent the only embodiments.
除非另有定义,本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施方式的目的,不是旨在于限制本发明。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the technical field of the invention. The terminology used herein in the description of the present invention is only for the purpose of describing specific embodiments, and is not intended to limit the present invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
在覆膜支架领域,将覆膜支架植入血管后,定义血流从覆膜支架的近端流向该覆膜支架的远端。In the field of stent-grafts, after the stent-grafts are implanted into blood vessels, it is defined that the blood flow flows from the proximal end of the stent-grafts to the distal end of the stent-grafts.
本申请中“覆膜支架”是指裸支架表面覆盖有薄膜后的结构,裸支架是指包括多个波形环状物且各波形环状物之间没有薄膜的结构。In this application, "covered stent" refers to the structure of the surface of the bare stent covered with a thin film, and the bare stent refers to a structure including a plurality of corrugated rings without a thin film between the corrugated rings.
请参阅图1,分叉型覆膜支架10包括管状主体100及与所述管状主体100连通的侧分支200。所述管状主体100包括第一裸支架101及设于所述第一裸支架101的第一覆膜103。所述第一裸支架101包括至少一个非端部波形环状物102。所述侧分支200包括第二覆膜201。所述第二覆膜201与所述第一覆膜103连接。所述第一覆膜102与所述第二覆膜201的接口110处设置有沿所述接口110外周分布的膨胀环120,且所述膨胀环120至少部分位于所述管状主体100设置有所述非端部波形环状物102的圆周面上。Referring to FIG. 1 , the bifurcated stent graft 10 includes a tubular body 100 and a side branch 200 communicating with the tubular body 100 . The tubular body 100 includes a first bare stent 101 and a first membrane 103 disposed on the first bare stent 101 . The first bare stent 101 comprises at least one non-end wave ring 102 . The side branch 200 includes a second coating 201 . The second coating 201 is connected to the first coating 103 . The interface 110 between the first membrane 102 and the second membrane 201 is provided with an expansion ring 120 distributed along the periphery of the interface 110, and the expansion ring 120 is at least partially located on the tubular body 100. The circumferential surface of the non-end wave ring 102.
本申请中,波形环状物的圆周面,指该波形环状物多个波峰的连线与多个波谷的连线围合起来的、且包括该波形环状物的区域。In the present application, the circumferential surface of the wave-shaped ring refers to the area enclosed by the line connecting multiple crests and the line connecting multiple troughs of the wave-shaped ring and including the wave-shaped ring.
具体的,管状主体100的纵向中心轴线与侧分支200的纵向中心轴线之间形成一定的夹角,侧分支200与管状主体100的连接处形成接口110,即,第一覆膜103与第二覆膜201的连接处形成接口110。具体到本实施例中,第一覆膜103与第二覆膜201的连接可以通过缝合、粘结或热熔烧结等方式,或者第一覆膜103与第二覆膜201也可以为一体结构。第一覆膜103与第二覆膜201均可采用生物相容性的薄膜结构,例如,采用PET(Polyethyleneterephthalate,聚对苯二甲酸乙二醇酯)或者PTFE(Polytetrafluoroethene,聚四氟乙烯)作为覆膜材料。裸支架101可以采用金属丝,例如,将金属丝编织或切割成所需波形,金属丝可采用镍钛合金丝,如直径为0.40mm的镍钛合金丝。Specifically, a certain angle is formed between the longitudinal central axis of the tubular main body 100 and the longitudinal central axis of the side branch 200, and the junction of the side branch 200 and the tubular main body 100 forms an interface 110, that is, the first film 103 and the second The joints of the covering films 201 form the interface 110 . Specifically in this embodiment, the connection between the first coating 103 and the second coating 201 can be through sewing, bonding, or hot-melt sintering, or the first coating 103 and the second coating 201 can also be integrated. . Both the first covering film 103 and the second covering film 201 can adopt a biocompatible film structure, for example, use PET (Polyethyleneterephthalate, polyethylene terephthalate) or PTFE (Polytetrafluoroethene, polytetrafluoroethylene) as Laminating material. The bare stent 101 may use a metal wire, for example, braid or cut the metal wire into a desired waveform, and the metal wire may be a nickel-titanium alloy wire, such as a nickel-titanium alloy wire with a diameter of 0.40 mm.
请继续参阅图1,第一裸支架101、膨胀环120与第一覆膜103通过缝合方式连接,缝合点105的数量和位置依据实际需要确定。Please continue to refer to FIG. 1 , the first bare stent 101 , the expansion ring 120 and the first membrane 103 are connected by suturing, and the number and positions of the suturing points 105 are determined according to actual needs.
当然,在其他实施例中,裸支架101、膨胀环120和第一覆膜103之间还可以通过覆膜烧结,或者粘贴方式形成。例如,可以在裸支架101的内表面和外表面整体覆盖聚四氟乙烯膜,裸支架101和膨胀环120均位于两层覆膜中间,通过高温加压的方式,将内外层的聚四氟乙烯覆膜粘接在一起,从而将裸支架101及膨胀环120固定在覆膜之间。Of course, in other embodiments, the bare stent 101 , the expansion ring 120 and the first membrane 103 may also be formed by membrane sintering or pasting. For example, the inner surface and the outer surface of the bare stent 101 can be covered with polytetrafluoroethylene film as a whole, and the bare stent 101 and the expansion ring 120 are both located in the middle of the two layers of covering films. The vinyl covers are bonded together, thereby securing the bare stent 101 and expandable ring 120 between the covers.
需要说明的是,侧分支200的直径可以与管状主体100的直径相等,也可以不相等,例如,侧分支200的直径可以小于管状主体100的直径。It should be noted that the diameter of the side branch 200 may be equal to or not equal to the diameter of the tubular main body 100 , for example, the diameter of the side branch 200 may be smaller than the diameter of the tubular main body 100 .
在本实施例中,管状主体100的纵向中心轴线与侧分支200的纵向中心轴线之间形成的夹角为锐角,接口110呈椭圆形。需要说明的是,在其他实施例中,管状主体100的纵向中心轴线与侧分支200的纵向中心轴线之间的夹角不局限于此,接口110的形状也可以为其他,例如,侧分支200的纵向中心轴线还可以与管状主体100的纵向中心轴线垂直,接口110呈圆形。当然,接口110还可为其他空间闭合曲线。In this embodiment, the angle formed between the longitudinal central axis of the tubular body 100 and the longitudinal central axis of the side branch 200 is an acute angle, and the interface 110 is elliptical. It should be noted that, in other embodiments, the angle between the longitudinal central axis of the tubular body 100 and the longitudinal central axis of the side branch 200 is not limited thereto, and the shape of the interface 110 can also be other, for example, the side branch 200 The longitudinal central axis of the tubular body 100 may also be perpendicular to the longitudinal central axis of the tubular body 100, and the interface 110 is circular. Certainly, the interface 110 may also be other space closed curves.
一般地,支架具有压缩状态和释放状态,压缩后的支架束缚在输送器的鞘管中,用于在血管中输送,到达靶病位置后通过各个覆膜上的各个裸支架的自膨胀释放,通常释放后的支架的径长略大于血管的径长,从而使得支架紧密贴覆血管壁,形成新的血流通道。可以理解,由于管状主体100与侧分支200的接口110处无裸支架支撑,容易导致呈椭圆形的接口110变形成扁缝状接口,不仅易造成血流通道变窄,而且还将阻碍导丝顺利进入。上述分叉型覆膜支架10,通过在接口110处设置膨胀环120,且所述膨胀环120至少部分位于所述管状主体100设置有所述非端部波形环状物102的圆周面上,膨胀环120为接口110提供支撑力,支架释放后,膨胀环120能够随着第一裸支架101的自膨胀而径向扩展,以保持接口110处的径向宽度,从而保证血流顺利地从管状主体100内通过接口110流进侧分支200,使侧分支200血流通畅、充足,且易于导丝进入。同时,管状主体100与侧分支200可以采用相互独立的裸支架,可以提高侧分支200与主体100之间的柔顺性,提高了支架的适应性。Generally, the stent has a compressed state and a released state. The compressed stent is bound in the sheath of the delivery device for delivery in the blood vessel. After reaching the target disease site, it is released by self-expansion of each bare stent on each membrane. Usually, the diameter length of the released stent is slightly longer than that of the blood vessel, so that the stent closely adheres to the blood vessel wall and forms a new blood flow channel. It can be understood that since there is no bare support at the interface 110 between the tubular main body 100 and the side branch 200, the oval-shaped interface 110 is easily deformed into a flat seam-like interface, which not only easily narrows the blood flow channel, but also hinders the guide wire. Get in without a hitch. In the bifurcated stent graft 10, an expansion ring 120 is provided at the interface 110, and the expansion ring 120 is at least partially located on the circumferential surface of the tubular body 100 provided with the non-end wave ring 102, The expansion ring 120 provides support force for the interface 110. After the stent is released, the expansion ring 120 can radially expand with the self-expansion of the first bare stent 101 to maintain the radial width of the interface 110, thereby ensuring the smooth flow of blood from The inside of the tubular main body 100 flows into the side branch 200 through the interface 110, so that the blood flow in the side branch 200 is smooth and sufficient, and the guide wire is easy to enter. At the same time, the tubular main body 100 and the side branch 200 can adopt independent bare stents, which can improve the flexibility between the side branch 200 and the main body 100 and improve the adaptability of the stent.
请继续参阅图2,所述第一裸支架101还包括近端波形环状物1021、远端波形环状物1023,所述至少一个非端部波形环状物102设置于所述近端波形环状物1021与所述远端波形环状物1023之间。所述非端部波形环状物102为开口环,所述膨胀环120位于所述非端部波形环状物102的开口处。Please continue to refer to FIG. 2 , the first bare stent 101 also includes a proximal waveform ring 1021 and a distal waveform ring 1023, and the at least one non-end waveform ring 102 is arranged on the proximal waveform between the ring 1021 and the distal wave-shaped ring 1023 . The non-end wave-shaped ring 102 is an open ring, and the expansion ring 120 is located at the opening of the non-end wave-shaped ring 102 .
具体的,近端波形环状物1021及远端波形环状物1023均为封闭环,非端部波形环状物102与近端波形环状物1021及远端波形环状物1023形状相似,且非端部波形环状物102的圆弧形周面与近端波形环状物1021、远端波形环状物1023的周面共面。近端波形环状物1021、远端波形环状物1023及非端部波形环状物102可以具有相同或相似的波形形状,例如,波形形状可以是Z形波、M形波或正弦波等。Specifically, both the near-end waveform ring 1021 and the distal waveform ring 1023 are closed rings, and the non-end waveform ring 102 is similar in shape to the proximal waveform ring 1021 and the distal waveform ring 1023, And the arc-shaped peripheral surface of the non-end wave-shaped ring 102 is in the same plane as the peripheral surfaces of the proximal wave-shaped ring 1021 and the distal wave-shaped ring 1023 . The near-end waveform ring 1021, the distal waveform ring 1023 and the non-end waveform ring 102 can have the same or similar waveform shapes, for example, the waveform shapes can be Z-shaped waves, M-shaped waves or sine waves, etc. .
进一步的,所述膨胀环120与所述非端部波形环状物102的自由端相连。进一步的,所述非端部波形环状物102的个数至少为两个,所述膨胀环120与至少两个所述非端部波形环状物102的所有自由端均相连。具体到本实施例中,请参阅图2,非端部波形环状物102的个数为两个,靠近近端波形环状物1021的非端部波形环状物102的两个自由端均结束在波谷位置处,靠近远端波形环状物1023的非端部波形环状物102的两个自由端结束在波峰位置处,膨胀环120位于两个非端部波形环状物102的开口处,膨胀环120与两个波形环状物102的四个自由端均相连。Further, the expansion ring 120 is connected to the free end of the non-end wave-shaped ring 102 . Further, the number of the non-end wave-shaped rings 102 is at least two, and the expansion ring 120 is connected to all free ends of the at least two non-end wave-shaped rings 102 . Specifically in this embodiment, please refer to FIG. 2 , the number of non-end wave-shaped rings 102 is two, and the two free ends of the non-end wave-shaped rings 102 near the near-end wave-shaped ring 1021 are both Ending at the trough position, the two free ends of the non-end wave-shaped ring 102 near the distal wave-shaped ring 1023 end at the peak position, and the expansion ring 120 is located at the opening of the two non-end wave-shaped rings 102 , the expansion ring 120 is connected to the four free ends of the two wave-shaped rings 102 .
需要说明的是,非端部波形环状物102也可以为多个,膨胀环120位于多个非端部波形环状物102的开口处。可以理解的是,其他实施例中,膨胀环120可以与所有的非端部波形环状物102的自由端均连接,也可以选择性的与部分非端部波形环状物102的自由端连接,还可以与所有的非端部波形环状物102的自由端均呈断开状态。It should be noted that there may be multiple non-end wave-shaped rings 102 , and the expansion ring 120 is located at openings of the non-end wave-shaped rings 102 . It can be understood that, in other embodiments, the expandable ring 120 may be connected to the free ends of all non-end wave-shaped rings 102, or may be selectively connected to the free ends of some non-end wave-shaped rings 102. , can also be disconnected from all the free ends of the non-end wave-shaped rings 102 .
当然,在其他实施例中,膨胀环120也可以与非端部波形环状物102的自由端不连接,即,膨胀环120与非端部波形环状物102的自由端之间具有一定的间隔。Of course, in other embodiments, the expandable ring 120 may not be connected to the free end of the non-end wave-shaped ring 102, that is, there is a certain gap between the expandable ring 120 and the free end of the non-end wave-shaped ring 102. interval.
具体的,所述膨胀环120包括金属丝绕所述接口110外周环绕形成的膨胀部121及与所述膨胀部121连接的活动部122。所述膨胀部121至少部分位于所述非端部波形环状物102的圆周面上。膨胀部121用于在支架释放后自膨胀以维持接口110的轮廓形态。活动部122与非端部波形环状物102相连,如此,待非端部波形环状物102不受束缚而恢复至自然状态的过程中,活动部122也可以在非端部波形环状物的102的带动下促使膨胀环120更快地自膨胀以维持接口110的轮廓形态,从而更加有效地保证血流顺利的从管状主体100内通过接口110流进侧分支200,使侧分支200血流通畅、充足,且易于导丝进入。Specifically, the expansion ring 120 includes an expansion part 121 formed by a metal wire around the periphery of the interface 110 and a movable part 122 connected to the expansion part 121 . The expansion portion 121 is at least partially located on the circumferential surface of the non-end wave-shaped ring 102 . The expansion part 121 is used for self-expanding to maintain the contour shape of the interface 110 after the stent is released. The movable part 122 is connected with the non-end wave-shaped ring 102, so that when the non-end wave-shaped ring 102 is unconstrained and returns to the natural state, the movable part 122 can also be in the non-end wave-shaped ring. Driven by 102, the expansion ring 120 self-expands faster to maintain the contour shape of the interface 110, thereby more effectively ensuring that the blood flow smoothly from the tubular main body 100 through the interface 110 into the side branch 200, so that the side branch 200 blood The flow is clear, adequate, and easy for guidewire access.
本实施例中,膨胀部121为闭合环状结构;活动部122的个数为两个,两个活动部122分别位于膨胀部121的两侧;一个活动部122与膨胀环120一侧的两个非端部波形环状物102的两个自由端相连,另一个活动部122与膨胀环120另一侧的两个的非端部波形环状物102的两个自由端相连。In this embodiment, the expansion part 121 is a closed ring structure; the number of movable parts 122 is two, and the two movable parts 122 are respectively located on both sides of the expansion part 121; The two free ends of the two non-end wave-shaped rings 102 are connected, and the other movable part 122 is connected with the two free ends of the two non-end wave-shaped rings 102 on the other side of the expansion ring 120 .
当然,在其他实施例中,膨胀环120还可以省略活动部122,例如,采用其他弹性较好的材料完全沿接口110外周环绕一周形成,如,镍钛合金制成的弹性圈、材料本身具有膨胀能力的高分子材料制成的闭合环。Certainly, in other embodiments, the movable part 122 can also be omitted for the expansion ring 120, for example, other materials with better elasticity are used to form a circle around the outer circumference of the interface 110, such as an elastic ring made of nickel-titanium alloy, and the material itself has Closed ring made of swellable polymer material.
进一步的,请参阅图2,所述膨胀环120具有靠近所述近端波形环状物1021的最高点123及靠近所述远端波形环状物1023的最低点124,所述活动部122位于所述最低点124与所述最高点123的连线的一侧。Further, referring to FIG. 2 , the expandable ring 120 has a highest point 123 close to the proximal wave-shaped ring 1021 and a lowest point 124 close to the distal wave-shaped ring 1023 , and the movable part 122 is located at One side of the line connecting the lowest point 124 and the highest point 123 .
更进一步的,所述活动部122至少一个端点不与最高点123及最低点124重合。例如,所述活动部122的一端位于最高点123处,另一端的高度高于最低点124所在的高度。又如,所述活动部122的一端位于最低点124处,另一端的高度低于最高点123所在的高度。又如,所述活动部122的一端的高度高于最低点124所在的高度,另一端的高度低于最高点123所在的高度,以使膨胀环120在支架释放后具有较大的回弹力,较好地恢复接口110处的轮廓形态。Furthermore, at least one end point of the movable part 122 does not coincide with the highest point 123 and the lowest point 124 . For example, one end of the movable part 122 is located at the highest point 123 , and the height of the other end is higher than that of the lowest point 124 . As another example, one end of the movable part 122 is located at the lowest point 124 , and the height of the other end is lower than that of the highest point 123 . As another example, the height of one end of the movable part 122 is higher than the height of the lowest point 124, and the height of the other end is lower than the height of the highest point 123, so that the expansion ring 120 has a greater resilience after the stent is released, The contour morphology at the interface 110 is better restored.
可以理解,活动部122还可以设置于膨胀环120的其他位置。例如,活动部122还可以设置于膨胀环120的最高点123或最低点124附近。换言之,活动部122的两端分别位于最高点123的两侧;或者,活动部122的两端分别位于最低点124的两侧。It can be understood that the movable part 122 can also be disposed at other positions of the expansion ring 120 . For example, the movable part 122 can also be disposed near the highest point 123 or the lowest point 124 of the expansion ring 120 . In other words, the two ends of the movable part 122 are respectively located on both sides of the highest point 123 ; or, the two ends of the movable part 122 are respectively located on both sides of the lowest point 124 .
进一步的,所述活动部122两端点之间的连线与所述膨胀环120的所述最低点124与所述最高点123之间的连线平行。活动部122靠近最高点123的端点至所述最低点124与所述最高点123之间的连线的距离与活动部122靠近最低点124的端点至所述最低点124与所述最高点123之间的连线的距离相等,以提高膨胀环120的对称性,较好地确保接口110处的轮廓形态。Further, the line between the two ends of the movable part 122 is parallel to the line between the lowest point 124 and the highest point 123 of the expansion ring 120 . The distance between the end point of the movable part 122 close to the highest point 123 and the line between the lowest point 124 and the highest point 123 and the distance between the end point of the movable part 122 close to the lowest point 124 to the lowest point 124 and the highest point 123 The distances between the connecting lines are equal to improve the symmetry of the expansion ring 120 and better ensure the contour shape of the interface 110 .
可以理解的是,在其他实施例中,多个非端部波形环状物中还可以至少有一个非端部波形环状物为闭环结构,而膨胀环位于两个相邻的非端部波形环状物之间,例如位于两个均为开环结构的相邻的非端部波形环状物之间,或者位于两个均为闭环结构的相邻的非端部波形环状物之间,或者位于相邻的呈闭环结构的非端部波形环状物及呈开环结构的非端部波形环状物之间。还可以理解的是,在其他实施例中,膨胀环也可以只与一个非端部波形环状物相连,与其他的非端部波形环状物间隔一段距离。It can be understood that, in other embodiments, at least one of the non-end wave-shaped rings may have a closed-loop structure, and the expansion ring is located between two adjacent non-end wave-shaped rings. Between rings, such as between two adjacent non-terminal wave-shaped rings that are both open-loop structures, or between two adjacent non-terminal wave-shaped rings that are both closed-loop structures , or between adjacent non-end wave-shaped rings in a closed-loop structure and non-end wave-shaped rings in an open-loop structure. It can also be understood that, in other embodiments, the expandable ring can also be connected to only one non-end wave-shaped ring, and be separated from other non-end wave-shaped rings by a certain distance.
请参阅图3,活动部122为设置于所述膨胀环120上的缺口(图未标),即,膨胀环120为非封闭结构。具体到本实施例中,所述缺口为一个,膨胀环120的两端分别与两个非端部波形环状物102的自由端连接,所述缺口的间距为两个波形环状物102的位于膨胀环120一侧的两个自由端之间的距离,即,膨胀环120的一侧连接两个非端部波形环状物102的自由端,另一侧的两个非端部波形环状物102的两个自由端断开,形成活动部122。Please refer to FIG. 3 , the movable part 122 is a gap (not shown) provided on the expansion ring 120 , that is, the expansion ring 120 is a non-closed structure. Specifically in this embodiment, the gap is one, and the two ends of the expansion ring 120 are respectively connected to the free ends of the two non-end wave-shaped rings 102, and the distance between the gaps is the distance between the two wave-shaped rings 102. The distance between the two free ends on one side of the expansion ring 120, that is, the free ends of the two non-end wave rings 102 connected on one side of the expansion ring 120, and the two non-end wave rings on the other side The two free ends of the bar 102 are disconnected to form the movable part 122 .
请参阅图4,在其中一个实施例中,所述缺口为两个,两个所述缺口将膨胀环120切割成两个沿管状主体100的纵向中心轴线方向排列的膨胀部121。每一所述膨胀部121的两端分别与一个所述非端部波形环状物102两对应的自由端连接。例如,两个相邻的非端部波形环状物102上设置有两个相对的半椭圆结构,形成膨胀部121,两个半椭圆之间具有一定的间隔,形成活动部122。优选的,所述膨胀环120的缺口两端沿管状主体100的纵向中心轴线的间距D不大于所述膨胀环120的最高点123与最低点124之间的沿管状主体100的纵向中心轴线的长度L的0.15倍,即,D≤0.15L。这是因为,若D大于0.15L,则,第一覆膜103接口110附近无金属支撑的区域较大,这样,第一覆膜103在接口110处容易形成褶皱,进而影响血流的流通。Referring to FIG. 4 , in one embodiment, there are two notches, and the two notches cut the expansion ring 120 into two expansion parts 121 arranged along the longitudinal central axis of the tubular body 100 . Two ends of each expansion portion 121 are respectively connected to two corresponding free ends of one non-end wave-shaped ring 102 . For example, two opposite semi-ellipse structures are provided on two adjacent non-end wave-shaped rings 102 to form the expansion part 121 , and there is a certain interval between the two semi-ellipse structures to form the movable part 122 . Preferably, the distance D between the two ends of the notch of the expansion ring 120 along the longitudinal center axis of the tubular body 100 is not greater than the distance D between the highest point 123 and the lowest point 124 of the expansion ring 120 along the longitudinal center axis of the tubular body 100 0.15 times the length L, ie, D≤0.15L. This is because, if D is greater than 0.15L, the area without metal support near the interface 110 of the first film 103 is large, so that the first film 103 is likely to form wrinkles at the interface 110, thereby affecting the flow of blood.
可以理解的是,膨胀部121可以为非端部波形环状物102的一部分,即,膨胀部121与非端部波形环状物102为一体成型结构。换言之,通过改变非端部波形环状物102上接口110处的波形,以使其与接口110的轮廓吻合,可以得到膨胀环120,这样不需要附加其他金属环,仅改变现有的非端部波形环状物102位于接口110处的波形结构即可以维持接口110处的轮廓形态,从而保证血流顺利的从管状主体100内通过接口110流进侧分支200,使侧分支200血流通畅、充足,且易于导丝进入。It can be understood that the expansion portion 121 may be a part of the non-end wave-shaped ring 102 , that is, the expansion portion 121 and the non-end wave-shaped ring 102 are integrally formed. In other words, the expansion ring 120 can be obtained by changing the waveform at the interface 110 on the non-end wave-shaped ring 102 to match the contour of the interface 110, so that no other metal rings need to be added, and only the existing non-end is changed. The waveform structure of the inner wave ring 102 at the interface 110 can maintain the contour shape of the interface 110, thereby ensuring that the blood flow smoothly flows from the tubular body 100 into the side branch 200 through the interface 110, so that the blood flow of the side branch 200 is smooth. , Adequate, and easy guidewire access.
请参阅图5,在一实施例中,所述膨胀部121为开环结构,且膨胀部121相对的两个端部彼此先相互靠近再相互远离地延伸形成重叠区域(图未标),所述重叠区域即形成所述活动部122,如图5中虚线区域所示。例如,采用一根具有生物相容性材料的金属丝定型制成与接口110形状吻合,且两端重合的膨胀环120,重叠区域处的两金属丝端部为自由状态,这样,支架10在装入输送器时,接口110在受到挤压的情况下两个自由端可活动,使接口110处的结构具有更大的压缩量,装入输送器时所受的阻力较小且支架10释放时受到的阻力也较小。Please refer to FIG. 5. In one embodiment, the expansion part 121 is an open-loop structure, and the two opposite ends of the expansion part 121 first approach each other and then extend away from each other to form an overlapping area (not shown in the figure). The overlapping area forms the movable portion 122, as shown by the dotted line area in FIG. 5 . For example, a metal wire with a biocompatible material is used to form an expansion ring 120 that conforms to the shape of the interface 110, and the two ends overlap, and the ends of the two metal wires in the overlapping area are in a free state. When loaded into the conveyor, the two free ends of the interface 110 are movable under the condition of being squeezed, so that the structure at the interface 110 has a greater amount of compression, and the resistance encountered when loaded into the conveyor is small and the bracket 10 is released There is also less resistance.
在本实施例中,膨胀环120位于非端部波形环状物102的开口处,且与非端部波形环状物102的自由端具有一定的间距。当然,在其他实施例中,膨胀环120也可以与非端部波形环状物102的自由端连接。In this embodiment, the expansion ring 120 is located at the opening of the non-end wave-shaped ring 102 and has a certain distance from the free end of the non-end wave-shaped ring 102 . Of course, in other embodiments, the expandable ring 120 can also be connected to the free end of the non-end wave-shaped ring 102 .
需要说明的是,为了避免刮伤血管,膨胀环120上要尽量避免形成较尖锐的部分,具体的,所述活动部122的末端1221呈圆滑状,该圆滑结构可以大致呈圆圈状、椭圆状、任意曲线状等,例如活动部122的末端1221可以大致呈圈状(请参阅图6)。It should be noted that, in order to avoid scratching the blood vessels, the expansion ring 120 should try to avoid forming sharper parts. Specifically, the end 1221 of the movable part 122 is in a smooth shape, and the smooth structure can be roughly in the shape of a circle or an ellipse. , any curved shape, etc., for example, the end 1221 of the movable part 122 may be roughly in the shape of a ring (see FIG. 6 ).
请参阅图7,膨胀环120为封闭结构,所述活动部122为设置于所述膨胀环120上的波形段,所述波形段包括若干个波形。进一步的,所述波形段的个数为两个,两个所述波形段对称设置。进一步的,所述波形为M形波、Z形波或正弦波的至少一种。Please refer to FIG. 7 , the expansion ring 120 is a closed structure, the movable part 122 is a wave segment disposed on the expansion ring 120 , and the wave segment includes several waves. Further, the number of the waveform segments is two, and the two waveform segments are arranged symmetrically. Further, the waveform is at least one of M-shaped wave, Z-shaped wave or sine wave.
在其中一实施例中,接口110处采用一封闭的具有生物相容性材料组成,可以是丝状编织或管状切割后定型而成。膨胀环120整体呈椭圆形,在长轴的两侧各有一个波形段,该波形段包括若干个波形,波形为具有一定规律Z形波。当支架在体内释放之后,膨胀环120处的波形段具有的弹性作用膨胀环120能够完全自膨回复形状,以保证接口110的轮廓形态。In one of the embodiments, the interface 110 is made of a closed biocompatible material, which can be formed by weaving filaments or cutting tubes and shaping them. The expansion ring 120 is generally elliptical, and there is a waveform section on both sides of the long axis. The waveform section includes several waveforms, and the waveform is a regular Z-shaped wave. After the stent is released in the body, the elastic effect of the wave section at the expansion ring 120 can fully self-expand and restore the shape, so as to ensure the contour shape of the interface 110 .
可以理解,波形还可以包括多种波的组合,例如,M形波、正弦波的组合。当然,波形段还可为螺旋结构。It can be understood that the waveform may also include a combination of various waves, for example, a combination of an M-shaped wave and a sine wave. Of course, the waveform segment can also be a helical structure.
以上所述实施例的各技术特征可以进行任意的组合,为使描述简洁,未对上述实施例中的各个技术特征所有可能的组合都进行描述,然而,只要这些技术特征的组合不存在矛盾,都应当认为是本说明书记载的范围。The technical features of the above-mentioned embodiments can be combined arbitrarily. To make the description concise, all possible combinations of the technical features in the above-mentioned embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, should be considered as within the scope of this specification.
以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。The above-mentioned embodiments only express several implementation modes of the present invention, and the descriptions thereof are relatively specific and detailed, but should not be construed as limiting the patent scope of the invention. It should be pointed out that those skilled in the art can make several modifications and improvements without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent for the present invention should be based on the appended claims.
Claims (15)
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