CN105662646A - Filter - Google Patents
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- CN105662646A CN105662646A CN201511024970.6A CN201511024970A CN105662646A CN 105662646 A CN105662646 A CN 105662646A CN 201511024970 A CN201511024970 A CN 201511024970A CN 105662646 A CN105662646 A CN 105662646A
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- distal end
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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
- A61F2/01—Filters implantable into blood vessels
- A61F2/0108—Both ends closed, i.e. legs gathered at both ends
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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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
- Prostheses (AREA)
Abstract
本发明公开了一种滤器,主要包括近心端过滤网和远心端过滤网,并且靠近近心端的近心端过滤网锥度小于靠近远心端的远心端过滤网锥度。因此,近心端过滤网的径向支撑力小于远心端过滤网的径向支撑力。待栓子被拦截于近心端过滤网时,近心端过滤网的径向支撑力增大,缩小了近心端过滤网的径向支撑力与远心端过滤网的径向支撑力之间的差距,减小了滤器歪斜的可能,提高了滤器过滤栓子的效率,减低了术后病患再次栓塞的风险。
The invention discloses a filter, which mainly includes a near-end filter net and a distal-end filter net, and the taper of the filter net near the proximal end is smaller than the taper of the filter net near the distal end. Therefore, the radial support force of the filter screen at the proximal end is smaller than the radial support force of the filter screen at the distal end. When the emboli is intercepted by the filter screen at the proximal end, the radial support force of the filter screen at the proximal end increases, reducing the difference between the radial support force of the filter screen at the proximal end and the radial support force of the filter screen at the distal end. The gap between them reduces the possibility of filter skew, improves the efficiency of the filter to filter emboli, and reduces the risk of re-embolism in patients after surgery.
Description
技术领域technical field
本发明涉及一种植入医疗器械,尤其涉及一种滤器。The invention relates to an implanted medical device, in particular to a filter.
背景技术Background technique
肺栓塞(简称:PE)是指体循环的各种栓子脱落阻塞肺动脉及其分支引起肺循环障碍的临床病理生理综合症,具有发病率高、发病急、病死率高等特点。有资料统计,不经治疗的肺栓塞死亡率为20~30%,每年新增病例约占人口的0.2%,按照我国13.5亿人口计算,每年约有270万新增患者。Pulmonary embolism (abbreviation: PE) refers to the clinicopathophysiological syndrome in which various emboli in the systemic circulation block the pulmonary artery and its branches and cause pulmonary circulation disturbance. It has the characteristics of high morbidity, acute onset, and high mortality. According to statistics, the mortality rate of untreated pulmonary embolism is 20-30%, and the annual new cases account for about 0.2% of the population. According to the calculation of my country's 1.35 billion population, there are about 2.7 million new patients every year.
体循环的各种栓子脱落均可引起肺栓塞。最常见的栓子为血栓。血栓的形成因素有多种,其中包括:外伤或骨折、创伤、较大的手术、大面积烧伤、妊娠、分娩、久病卧床、长途乘车或飞机久坐不动、长时间的静坐及下蹲等。这些血栓一般与管壁轻度粘连,容易脱落。脱落的游离栓子可引起肺栓塞等严重病变。滤器在临床上被证实为预防肺栓塞的安全有效的手段,可降低肺栓塞的发生率。滤器被植入到下腔静脉中,防止下肢脱落的血栓顺着血流到达肺部,从而预防肺栓塞。All kinds of emboli in the systemic circulation can cause pulmonary embolism. The most common type of emboli is a thrombus. There are many factors for the formation of blood clots, including: trauma or bone fractures, trauma, major surgery, extensive burns, pregnancy, childbirth, prolonged illness in bed, long-distance rides or airplanes, sedentary, prolonged sitting and sitting down. Squat and wait. These thrombi are generally slightly adhered to the tube wall and are easy to fall off. The dislodged free emboli can cause serious diseases such as pulmonary embolism. Filters have been clinically proven to be a safe and effective means of preventing pulmonary embolism, which can reduce the incidence of pulmonary embolism. A filter is implanted in the inferior vena cava to prevent blood clots from the lower extremities from reaching the lungs along the bloodstream, thereby preventing pulmonary embolism.
现有的滤器待栓子被拦截于近心端滤网时,易发生歪斜。而歪斜的滤器过滤栓子的效率降低,增加了术后病患再次栓塞的风险。The existing filter tends to be skewed when the emboli are intercepted by the filter screen at the proximal end. The skewed filter reduces the efficiency of filtering emboli, which increases the risk of re-embolism in patients after surgery.
发明内容Contents of the invention
本发明的目的在于,针对上述现有技术的不足,提供一种滤器。本发明滤器靠近滤器近心端的近心端过滤网的锥度小于靠近滤器远心端的远心端过滤网的锥度,近心端过滤网的径向支撑力小于远心端过滤网的径向支撑力。待栓子被拦截于近心端过滤网时,近心端过滤网的径向支撑力增大,缩小了近心端过滤网的径向支撑力与远心端过滤网的径向支撑力之间的差距,减小了滤器歪斜的可能,提高了滤器过滤栓子的效率,减低了术后病患再次栓塞的风险。The object of the present invention is to provide a filter for the above-mentioned deficiencies in the prior art. The taper of the filter screen at the proximal end of the filter near the proximal end of the filter is smaller than the taper of the filter screen at the distal end of the filter near the distal end of the filter, and the radial support force of the filter screen at the proximal end is smaller than the radial support force of the filter screen at the distal end. . When the emboli is intercepted by the filter screen at the proximal end, the radial support force of the filter screen at the proximal end increases, reducing the difference between the radial support force of the filter screen at the proximal end and the radial support force of the filter screen at the distal end. The gap between them reduces the possibility of filter skew, improves the efficiency of the filter to filter emboli, and reduces the risk of re-embolism in patients after surgery.
本发明提供一种滤器,其包括具有相对的近心端及远心端的主体部。所述主体部包括位于所述近心端及远心端之间且相连的近心端过滤网及远心端过滤网。在所述滤器自然释放的状态下,所述近心端过滤网和远心端过滤网均为多条网线构成的空间锥形结构。所述近心端过滤网的锥度小于所述远心端过滤网的锥度。The present invention provides a filter comprising a main body having opposite proximal and distal ends. The main body includes a proximal end filter and a distal end filter located between the proximal end and the distal end and connected to each other. When the filter is released naturally, both the filter screen at the proximal end and the filter screen at the distal end are spatially tapered structures formed by a plurality of wires. The taper of the filter net at the proximal end is smaller than the taper of the filter net at the distal end.
在其中一个实施例中,所述近心端过滤网包括多个相连的第一Y型单元。每个第一Y型单元均包括第一网线和由所述第一网线一端分叉延伸形成的两条第二网线。多个所述第一Y型单元的所述多条第一网线在所述近心端处汇聚。每个所述第一Y型单元的所述第二网线远离近心端的端部均与所述远心端过滤网相连。In one of the embodiments, the filter at the proximal end comprises a plurality of connected first Y-shaped units. Each first Y-shaped unit includes a first network cable and two second network cables formed by branching from one end of the first network cable. The plurality of first network cables of the plurality of first Y-shaped units converge at the proximal end. The end of the second mesh cable of each of the first Y-shaped units away from the proximal end is connected to the filter at the distal end.
在其中一个实施例中,在所述滤器自然释放的状态下,任一所述第一Y型单元中的所述第一网线与第二网线的连接点到所述滤器的纵向中心轴的距离与所述滤器在垂直于所述滤器的纵向中心轴方向上的外径最大处的尺寸的比值范围为1:10至7:16。In one of the embodiments, in the state where the filter is naturally released, the distance between the connection point of the first mesh wire and the second mesh wire in any of the first Y-shaped units to the longitudinal central axis of the filter The ratio to the dimension of the largest outer diameter of the filter in a direction perpendicular to the longitudinal central axis of the filter ranges from 1:10 to 7:16.
在其中一个实施例中,每相邻两个所述第一Y型单元的两条所述第一网线和相应的两个所述第一Y型单元的相邻的两条第二网线围合形成一个第一菱形过滤单元。在所述滤器自然释放的状态下,所述滤器的多个第一菱形过滤单元在垂直于所述滤器的纵向中心轴的横截面上的投影面积与所述滤器在垂直于所述滤器的纵向中心轴方向上的最大外径所对应的圆的面积之比范围为1:10至9:10。In one of the embodiments, the two first network lines of every two adjacent first Y-shaped units and the adjacent two second network lines of the corresponding two first Y-shaped units enclose A first diamond-shaped filter unit is formed. In the state where the filter is naturally released, the projected area of the plurality of first diamond-shaped filter units of the filter on a cross-section perpendicular to the longitudinal center axis of the filter is the same as that of the filter in the longitudinal direction perpendicular to the filter The area ratio of the circle corresponding to the maximum outer diameter in the direction of the central axis is in the range of 1:10 to 9:10.
在其中一个实施例中,所述远心端过滤网包括多个相连的第二Y型单元。每个第二Y型单元均包括第三网线和由所述第三网线一端分叉延伸形成的两条第四网线。多个所述第二Y型单元的多条第三网线在所述远心端处汇聚。每个第二Y型单元的的所述第四网线远离所述远心端的端部均与所述近心端过滤网相连。In one of the embodiments, the filter at the distal end includes a plurality of connected second Y-shaped units. Each second Y-shaped unit includes a third network cable and two fourth network cables formed by branching from one end of the third network cable. The multiple third network cables of the multiple second Y-shaped units converge at the distal end. The end of the fourth mesh cable of each second Y-shaped unit away from the distal end is connected to the filter at the proximal end.
在其中一个实施例中,在所述滤器自然释放的状态下,任一所述第二Y型单元中的所述第三网线与第四网线的连接点到所述滤器的纵向中心轴的距离与所述滤器自然释放后所述滤器在垂直于所述滤器的纵向中心轴方向上的外径最大处的尺寸的比值范围为1:10至7:16。In one of the embodiments, in the state where the filter is naturally released, the distance between the connection point of the third mesh wire and the fourth mesh wire in any of the second Y-shaped units to the longitudinal central axis of the filter The ratio of the size of the largest outer diameter of the filter in the direction perpendicular to the longitudinal central axis of the filter after the filter is naturally released is in the range of 1:10 to 7:16.
在其中一个实施例中,所述远心端过滤网包括多条直线型的第五网线。所述多条第五网线靠近所述远心端的端部在所述远心端处汇聚。每条所述第五网线的远离所述远心端的端部均与所述支撑段相连。In one of the embodiments, the filter at the distal end includes a plurality of straight fifth mesh wires. Ends of the plurality of fifth network cables close to the distal end converge at the distal end. The end of each fifth network cable away from the distal end is connected to the supporting section.
在其中一个实施例中,所述主体部还包括连接于所述近心端过滤网及远心端过滤网之间的支撑段。所述支撑段包括多根直杆。所述直杆大致平行于所述滤器的纵向中心轴。In one of the embodiments, the main body further includes a support section connected between the filter at the proximal end and the filter at the distal end. The support section includes a plurality of straight rods. The straight bar is generally parallel to the longitudinal center axis of the filter.
在其中一个实施例中,所述直杆的数量为多根,且多根所述直杆的长度相同。In one of the embodiments, there are multiple straight rods, and the lengths of the multiple straight rods are the same.
在其中一个实施例中,所述直杆沿所述滤器的周向方向的宽度大于所述近心端过滤网和所述远心端过滤网的任一网线沿所述滤器的周向方向的宽度。In one of the embodiments, the width of the straight bar along the circumferential direction of the filter is greater than that of any mesh line of the filter net at the proximal end and the filter net at the distal end along the circumferential direction of the filter. width.
在其中一个实施例中,所述支撑段还包括至少一根曲线型杆。所述曲线型杆的一端与所述近心端过滤网相连,另一端与所述远心端过滤网相连。In one of the embodiments, the support section further includes at least one curved rod. One end of the curved rod is connected with the filter screen at the proximal end, and the other end is connected with the filter screen at the distal end.
在其中一个实施例中,所述直杆和所述曲线型杆间隔分布于所述滤器的圆周方向。In one of the embodiments, the straight rods and the curved rods are distributed in the circumferential direction of the filter at intervals.
在其中一个实施例中,所述直杆和所述曲线型杆不间隔分布于所述滤器的圆周方向。In one embodiment, the straight rods and the curved rods are distributed in the circumferential direction of the filter without intervals.
在其中一个实施例中,至少一根所述直杆上设有至少一个用于固定所述滤器的固定锚。所述固定锚的一端固定于所述直杆上,所述固定锚的另一端为自由端且向所述近心端的方向延伸。In one of the embodiments, at least one fixing anchor for fixing the filter is provided on at least one of the straight rods. One end of the fixed anchor is fixed on the straight rod, and the other end of the fixed anchor is a free end extending toward the proximal end.
在其中一个实施例中,所述固定锚与与其直接相连的所述直杆之间的夹角小于90度。In one embodiment, the included angle between the fixed anchor and the straight rod directly connected thereto is less than 90 degrees.
在其中一个实施例中,所述固定锚的自由端至与其所在的所述固定锚直接相连的所述直杆的垂直距离小于或者等于3毫米。In one embodiment, the vertical distance from the free end of the fixed anchor to the straight rod directly connected to the fixed anchor is less than or equal to 3 millimeters.
在其中一个实施例中,所述滤器还包括回收钩。所述回收钩设置于所述主体部的远心端或近心端。所述回收钩为具有一开口的管状结构。所述回收钩的开口方向沿所述滤器的径向方向向外延伸且朝所述主体部偏移。所述回收钩的开口在垂直于所述开口方向上的宽度大于或等于所述回收钩的管状结构外径尺寸的1/5。所述回收钩的开口在垂直于所述滤器的纵向中心轴方向上的深度小于或等于所述回收钩的管状结构外径尺寸的19/20。In one of the embodiments, the filter further includes a recovery hook. The recovery hook is arranged at the distal end or the proximal end of the main body. The recovery hook is a tubular structure with an opening. The opening direction of the recovery hook extends outward along the radial direction of the filter and is offset toward the main body. The width of the opening of the recovery hook in a direction perpendicular to the opening is greater than or equal to 1/5 of the outer diameter of the tubular structure of the recovery hook. The depth of the opening of the recovery hook in a direction perpendicular to the longitudinal central axis of the filter is less than or equal to 19/20 of the outer diameter of the tubular structure of the recovery hook.
在其中一个实施例中,所述滤器的材料为镍钛合金。所述滤器通过在镍钛管上切割形成所述近心端过滤网和所述远心端过滤网的网线,并进行定型而成。In one embodiment, the material of the filter is nickel-titanium alloy. The filter is formed by cutting the wires of the near-end filter net and the distal-end filter net on a nickel-titanium tube, and shaping them.
本发明与现有技术相比,具有以下有益效果:Compared with the prior art, the present invention has the following beneficial effects:
本发明靠近滤器近心端的近心端过滤网的锥度小于靠近滤器远心端的远心端过滤网的锥度,近心端过滤网的径向支撑力小于远心端过滤网的径向支撑力。待栓子被拦截于近心端滤网时,近心端过滤网的径向支撑力增大,缩小了近心端过滤网的径向支撑力与远心端过滤网的径向支撑力之间的差距,减小了滤器歪斜的可能,提高了滤器过滤栓子的效率,减低了术后病患再次栓塞的风险。In the present invention, the taper of the filter screen at the proximal end close to the proximal end of the filter is smaller than the taper of the filter screen at the distal end near the distal end of the filter, and the radial support force of the filter screen at the proximal end is smaller than that of the filter screen at the distal end. When the emboli is intercepted by the filter screen at the proximal end, the radial support force of the filter screen at the proximal end increases, reducing the difference between the radial support force of the filter screen at the proximal end and the radial support force of the filter screen at the far end. The gap between them reduces the possibility of filter skew, improves the efficiency of the filter to filter emboli, and reduces the risk of re-embolism in patients after surgery.
附图说明Description of drawings
图1a-图1b为本发明第一实施例的滤器的整体结构示意图,所述滤器的主体部包括近心端过滤网、远心端过滤网和连接所述近心端过滤网和远心端过滤网的支撑段,所述近心端过滤网包括多个第一菱形过滤单元;其中,图1a为立体图,图1b为主视图;Figures 1a-1b are schematic diagrams of the overall structure of the filter according to the first embodiment of the present invention. The main body of the filter includes a filter screen at the proximal end, a filter screen at the distal end, and a filter screen connecting the proximal end and the distal end. The support section of the filter, the filter at the proximal end includes a plurality of first diamond-shaped filter units; wherein, Figure 1a is a perspective view, and Figure 1b is a main view;
图1c为图1a中所述滤器在具有滤器的纵向中心轴的截面上的剖视图;Figure 1c is a cross-sectional view of the filter described in Figure 1a on a section with a longitudinal central axis of the filter;
图1d为图1a中所述滤器的主体部的局部结构主视图;Figure 1d is a partial structural front view of the main body of the filter described in Figure 1a;
图1e为图1a中所述滤器的近心端过滤网在垂直于滤器的纵向中心轴的横截面上的投影图;Fig. 1 e is a projection view of the proximal end filter screen of the filter described in Fig. 1 a on a cross section perpendicular to the longitudinal central axis of the filter;
图1f为图1a中所述滤器的多个第一菱形过滤单元在垂直于所述滤器的纵向中心轴的横截面上的投影面积与所述滤器在垂直于所述滤器的纵向中心轴方向上的外径所对应的圆的面积之比示意图;Fig. 1f is the projected area of a plurality of first diamond-shaped filter units of the filter in Fig. 1a on a cross section perpendicular to the longitudinal central axis of the filter and the filter in the direction perpendicular to the longitudinal central axis of the filter Schematic diagram of the ratio of the area of the circle corresponding to the outer diameter of ;
图1g为图1a中所述滤器的远心端过滤网在垂直于滤器的纵向中心轴的横截面上的投影图;Fig. 1 g is the projected view of the far-end filter screen of the filter described in Fig. 1 a on the cross-section perpendicular to the longitudinal central axis of the filter;
图2为图1a中的滤器的回收钩的结构示意图;Fig. 2 is the schematic structural view of the recovery hook of the filter in Fig. 1a;
图3为图1a中的滤器的固定锚的结构示意图;Fig. 3 is the structural representation of the fixed anchor of the filter in Fig. 1a;
图4为图1a中的滤器绕着固定锚旋转的示意图;Fig. 4 is a schematic diagram of the filter in Fig. 1a rotating around a fixed anchor;
图5a-图5b为本发明第二实施例的滤器的整体结构示意图,所述滤器的主体部包括近心端过滤网、远心端过滤网和连接所述近心端过滤网和远心端过滤网的支撑段;其中,图5a为立体图,图5b为主视图;5a-5b are schematic diagrams of the overall structure of the filter according to the second embodiment of the present invention. The main body of the filter includes a filter screen at the proximal end, a filter screen at the distal end, and a filter screen connecting the proximal end filter screen and the distal end. The supporting section of the filter screen; wherein, Fig. 5a is a perspective view, and Fig. 5b is a main view;
图5c为图5a中所述滤器的主体部的局部结构主视图;Fig. 5c is a partial structural front view of the main body of the filter described in Fig. 5a;
图5d为图5a中所述滤器的远心端过滤网在垂直于滤器的纵向中心轴的横截面上的投影图;Figure 5d is a projection view of the filter screen at the distal end of the filter described in Figure 5a on a cross-section perpendicular to the longitudinal central axis of the filter;
图6为对比例一的滤器植入下腔静脉14天后取出,所述下腔静脉的显影图像。FIG. 6 is a developed image of the inferior vena cava after the filter of Comparative Example 1 was implanted in the inferior vena cava 14 days later.
具体实施方式detailed description
为了使本发明的目的、技术方案及优点更加清楚明白,以下结合附图及实施例,对本发明进行进一步详细说明。应当理解,此处所描述的具体实施例仅仅用以解释本发明,并不用于限定本发明。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 accompanying drawings and embodiments. It should be understood that the specific embodiments described here are only used to explain the present invention, not to limit the present invention.
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。本文在说明书中所使用的术语只是为了描述具体的实施例的目的,不是旨在于限制本发明。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 terms used herein in the specification are for the purpose of describing specific embodiments only, and are not intended to limit the present invention.
为了描述清晰,以下将滤器靠近心脏、血液流出滤器的一端称作近心端,将滤器远离心脏、血液流入滤器的一端称作远心端。For clarity of description, the end of the filter near the heart and blood flowing out of the filter is called the proximal end, and the end of the filter away from the heart and blood flowing into the filter is called the distal end.
以下将结合具体实施例进一步详细说明本发明的技术方案。The technical solutions of the present invention will be further described in detail below in conjunction with specific examples.
实施例一Embodiment one
本实施例中滤器的主体部采用外径尺寸为0.2-4mm的镍钛管切割、定型而成。可以理解,滤器也可由外径尺寸为0.05-0.8mm的镍钛丝或宽为0.05-0.5mm,长度为0.15-1mm的镍钛扁带通过编织、定型而成。所述滤器具有超弹性和自膨胀特性。In this embodiment, the main body of the filter is cut and shaped from a nickel-titanium tube with an outer diameter of 0.2-4 mm. It can be understood that the filter can also be braided and shaped by nickel-titanium wire with an outer diameter of 0.05-0.8 mm or a nickel-titanium flat belt with a width of 0.05-0.5 mm and a length of 0.15-1 mm. The filter has superelastic and self-expanding properties.
请参阅图1a及图1b,实施例一的滤器100包括主体部10和设置于主体部10一端的回收钩20以及固定锚30。Referring to FIG. 1 a and FIG. 1 b , the filter 100 of the first embodiment includes a main body 10 , a recovery hook 20 and a fixing anchor 30 disposed at one end of the main body 10 .
主体部10具有相对的近心端101和远心端102,其包括靠近近心端101的近心端过滤网11、靠近远心端102的远心端过滤网12及连接于近心端过滤网11及远心端过滤网12之间的支撑段13。当滤器100在血管中自然释放后,支撑段13用于支撑血管壁,近心端过滤网11和远心端过滤网12用于过滤血栓。近心端过滤网11由多条网线在近心端101汇聚形成空间锥形结构。远心端过滤网12由多条网线在远心端102汇聚形成空间锥形结构。The main body 10 has a proximal end 101 and a distal end 102, which include a proximal filter 11 near the proximal end 101, a distal filter 12 near the far end 102, and a filter connected to the proximal end. The support section 13 between the net 11 and the filter net 12 at the distal end. After the filter 100 is naturally released in the blood vessel, the supporting section 13 is used to support the blood vessel wall, and the proximal filter 11 and the distal filter 12 are used to filter thrombus. The filter screen 11 at the proximal end is composed of a plurality of mesh wires converged at the proximal end 101 to form a spatial tapered structure. The filter screen 12 at the distal end is composed of a plurality of mesh wires converged at the distal end 102 to form a spatial tapered structure.
每条网线可为直线型,或为曲线型,或部分为直线,其余部分为曲线型。Each network line can be straight, or curved, or partly straight and the rest curved.
可以理解的是,近心端过滤网11的网线和远心端过滤网12的网线还可以为不规则曲线或曲线与直线的组合。It can be understood that the mesh wires of the filter screen 11 at the proximal end and the screen wires of the filter screen 12 at the distal end can also be irregular curves or a combination of curves and straight lines.
请参阅图1c,近心端过滤网11的锥度为滤器100在自然释放状态时,近心端过滤网11的远心端的外径尺寸与近心端过滤网11在具有滤器100的纵向中心轴的截面上的投影沿滤器100的纵向中心轴的最大长度L1之比;远心端过滤网12的锥度为滤器100在自然释放状态时,远心端过滤网12的近心端的外径尺寸与远心端过滤网12在具有滤器100的纵向中心轴的截面上的投影沿滤器100的纵向中心轴的最大长度L2之比,并且近心端过滤网11的锥度小于远心端过滤网12的锥度。优选地,本实施例中,近心端过滤网11的远心端的外径尺寸等于远心端过滤网12的近心端的外径尺寸,且均等于滤器100在垂直于滤器100的纵向中心轴方向上的外径最大处的尺寸H。Referring to Fig. 1c, the taper of the filter screen 11 at the proximal end is that when the filter 100 is in a natural release state, the outer diameter of the distal end of the filter screen 11 at the proximal end is the same as that of the filter screen 11 at the proximal end with the longitudinal central axis of the filter 100 The ratio of the maximum length L1 of the projection on the section along the longitudinal central axis of the filter 100; the taper of the filter screen 12 at the far-center end is when the filter screen 100 is in a natural release state, the outer diameter of the proximal end of the filter screen 12 at the far-center end and the outer diameter of the proximal end of the filter screen 12 The ratio of the maximum length L2 of the projection of the filter screen 12 at the far-center end on the section having the longitudinal central axis of the filter 100 along the longitudinal central axis of the filter 100, and the taper of the filter screen 11 at the proximal end is less than that of the filter screen 12 at the far-center end taper. Preferably, in this embodiment, the outer diameter of the distal end of the proximal filter 11 is equal to the outer diameter of the proximal end of the distal filter 12, and is equal to the longitudinal central axis of the filter 100 perpendicular to the filter 100. The dimension H in the direction of the largest outer diameter.
在滤器100自然释放时,近心端过滤网11在具有滤器100的纵向中心轴的截面上的投影沿滤器100的纵向中心轴的最大长度L1大于远心端过滤网12在具有滤器100的纵向中心轴的截面上的投影沿滤器100的纵向中心轴的最大长度L2。When the filter 100 is released naturally, the projection of the filter screen 11 at the proximal end on the section with the longitudinal central axis of the filter 100 along the longitudinal central axis of the filter 100 is greater than the maximum length L1 of the filter screen 12 at the distal end in the longitudinal direction with the filter 100 The projection on the section of the central axis is along the maximum length L2 of the longitudinal central axis of the filter 100 .
靠近近心端101的近心端过滤网11长度较长,可以对由远心端102高速流入主体部10后的血流起到一定的缓冲作用,使血栓有序进入近心端过滤网11,不会形成涡流对近心端过滤网11造成较大冲击力导致滤器100移位。同时,较长的近心端过滤网11可以保证两股肾静脉回心血流对停留在近心端过滤网11的血栓产生足够大面积和足够长时间的冲刷切割作用,保证腔静脉的长期通畅。The proximal end filter 11 near the proximal end 101 has a longer length, which can buffer the blood flow from the distal end 102 into the main body 10 at high speed, so that thrombus can enter the proximal filter 11 in an orderly manner. Therefore, the vortex will not be formed to cause a large impact force on the filter screen 11 at the proximal end and cause the filter 100 to be displaced. Simultaneously, the longer filter screen 11 at the proximal end can ensure that the return blood flow of the two renal veins produces a sufficiently large area and a long enough washing and cutting effect on the thrombus staying in the filter screen 11 at the proximal end, ensuring the long-term maintenance of the vena cava. unobstructed.
请同时参阅图1d和1e,近心端过滤网11包括多个相连的第一Y型单元110,每个第一Y型单元110均包括第一网线111和由第一网线一端分叉延伸形成的两条第二网线112。多个第一Y型单元110的多条第一网线111在近心端101处汇聚,由此,当滤器100自然释放后,近心端过滤网11具有空间锥形结构。每个第一Y型单元110的第二网线远离近心端101的端部均与支撑段13相连。Please refer to Fig. 1d and 1e at the same time, the filter screen 11 at the proximal end includes a plurality of connected first Y-shaped units 110, and each first Y-shaped unit 110 includes a first mesh wire 111 and is formed by extending from one end of the first mesh wire. The two second network cables 112. The plurality of first mesh wires 111 of the plurality of first Y-shaped units 110 converge at the proximal end 101 , so that when the filter 100 is naturally released, the proximal end filter mesh 11 has a spatially tapered structure. The end of the second network cable of each first Y-shaped unit 110 away from the proximal end 101 is connected to the supporting section 13 .
每个第一Y型单元110的第二网线112与第一网线111的交点A在滤器100的纵向中心轴上的投影点到近心端101的距离与相应的第二网线112与支撑段13的交点在滤器100的纵向中心轴上的投影点到近心端101的距离之比范围为1:10至9:10。具体地,在本实施例中,该比值为1:2。The distance from the projection point of the intersection point A of the second mesh line 112 of each first Y-shaped unit 110 and the first mesh line 111 on the longitudinal center axis of the filter 100 to the proximal end 101 and the corresponding second mesh line 112 and the supporting section 13 The ratio of the distance from the projection point of the intersection point on the longitudinal central axis of the filter 100 to the proximal end 101 is in the range of 1:10 to 9:10. Specifically, in this embodiment, the ratio is 1:2.
每条第一网线111和第二网线112皆可分别呈直线型,也可呈曲线型,还可部分呈曲线型,其余部分呈直线型。本实施例中,近心端过滤网11包括六条长度相等的直线型第一网线111和十二条长度相等的直线型第二网线112。每相邻两条第一网线111在近心端101处形成的夹角相等。Each of the first network cable 111 and the second network cable 112 can be straight or curved, or part of it can be curved and the rest can be straight. In this embodiment, the proximal filter 11 includes six straight first mesh wires 111 of equal length and twelve straight second mesh wires 112 of equal length. The included angles formed by every two adjacent first mesh wires 111 at the proximal end 101 are equal.
请继续参阅图1c,在滤器100自然释放时,第一Y型单元110中的第一网线111与第二网线112的连接点A到滤器100的纵向中心轴的距离h1与滤器100在垂直于滤器100的纵向中心轴方向上的外径最大处的尺寸H的比值范围为1:10至7:16。具体地,在本实施例中,该比值为1:4。Please continue to refer to Fig. 1c, when the filter 100 is released naturally, the distance h 1 from the connection point A of the first mesh wire 111 and the second mesh wire 112 in the first Y-shaped unit 110 to the longitudinal central axis of the filter 100 is perpendicular to the filter 100 The ratio of the dimension H at the largest outer diameter in the direction of the longitudinal central axis of the filter 100 ranges from 1:10 to 7:16. Specifically, in this embodiment, the ratio is 1:4.
请同时参阅图1e和图1f,每相邻两个第一Y型单元110的两条第一网线111和相应的两个第一Y型单元110的相邻的两条第二网线112围合形成一个第一菱形过滤单元113。在所述滤器自然释放的状态下,近心端过滤网11的多个第一菱形过滤单元113在垂直于滤器100的纵向中心轴的横截面上的投影面积S1与滤器100的纵向中心轴方向上的最大外径所对应的圆的面积S0之比范围为1:10至9:10。具体地,在本实施例中,该比值为5.5:10。Please refer to Fig. 1e and Fig. 1f at the same time, the two first network lines 111 of every two adjacent first Y-shaped units 110 and the adjacent two second network lines 112 of the corresponding two first Y-shaped units 110 surround A first diamond-shaped filter unit 113 is formed. Under the state that described filter is released naturally, the projected area S1 of a plurality of first rhombic filtering units 113 of the near-center end filter screen 11 on the cross section perpendicular to the longitudinal central axis of the filter 100 is different from the longitudinal central axis direction of the filter 100 The ratio of the area S0 of the circle corresponding to the maximum outer diameter on the above ranges from 1:10 to 9:10. Specifically, in this embodiment, the ratio is 5.5:10.
由于第一菱形过滤单元113的尺寸适中,既能充分过滤会引起肺栓塞的血栓,也不存在由于大小血栓均被拦截造成血管阻塞的情况,保证了静脉的长期通畅。Because the size of the first rhombic filter unit 113 is moderate, it can fully filter the thrombus that will cause pulmonary embolism, and there is no situation that blood vessels are blocked due to the interception of large and small thrombus, which ensures the long-term patency of the vein.
请同时参阅图1d和图1g,远心端过滤网12包括多个相连的第二Y型单元120。每个第二Y型单元120均包括第三网线121和由第三网线一端分叉延伸形成的两条第四网线122。多个第二Y型单元120的多条第三网线121在远心端102处汇聚。由此,当滤器100自然释放后,远心端过滤网12具有空间锥形结构。每个第二Y型单元120的第四网线122远离远心端102的端部均与支撑段13相连。Please refer to FIG. 1d and FIG. 1g at the same time, the distal filter 12 includes a plurality of connected second Y-shaped units 120 . Each second Y-shaped unit 120 includes a third network cable 121 and two fourth network cables 122 formed by branching from one end of the third network cable. The multiple third network cables 121 of the multiple second Y-shaped units 120 converge at the distal end 102 . Therefore, when the filter 100 is naturally released, the filter screen 12 at the distal end has a spatially tapered structure. The end of the fourth network cable 122 of each second Y-shaped unit 120 away from the distal end 102 is connected to the supporting section 13 .
每条第三网线121和第四网线122皆可分别呈直线型,也可呈曲线型,还可部分呈曲线型,其余部分呈直线型。本实施例中,远心端过滤网12包括六条长度相等的直线型第三网线121和六条长度相等的直线型第四网线122。每相邻两条第三网线121在远心端102处形成的夹角相等。Each of the third network cable 121 and the fourth network cable 122 can be straight or curved, or part of it can be curved and the rest can be straight. In this embodiment, the filter screen 12 at the distal end includes six straight third mesh wires 121 of equal length and six straight fourth mesh wires 122 of equal length. The included angles formed by every two adjacent third mesh wires 121 at the distal end 102 are equal.
请继续参阅图1c,在滤器100自然释放时,每个第二Y型单元120中的第三网线121与第四网线122的连接点B到滤器100的纵向中心轴的距离h2与滤器100在垂直于滤器100的纵向中心轴方向上的外径最大处的尺寸H的比值范围为1:10至7:16。具体地,在本实施例中,该比值为1:8。Please continue to refer to Fig. 1 c, when the filter 100 is released naturally, the distance h 2 from the connection point B of the third mesh wire 121 and the fourth mesh wire 122 in each second Y-shaped unit 120 to the longitudinal central axis of the filter 100 is equal to the distance h 2 of the filter 100 The ratio of the dimension H at the largest outer diameter in the direction perpendicular to the longitudinal central axis of the filter 100 ranges from 1:10 to 7:16. Specifically, in this embodiment, the ratio is 1:8.
如上可知,滤器100的主体部10在整体上呈非对称结构,近心端过滤网11中的第一Y型单元110的数量为远心端过滤网12中的第二Y型单元120的数量的两倍,即近心端过滤网11的网状结构的密度大于远心端过滤网12的网状结构的密度。As can be seen above, the main body 10 of the filter 100 has an asymmetric structure as a whole, and the number of the first Y-shaped units 110 in the filter screen 11 at the proximal end is the number of the second Y-shaped units 120 in the filter screen 12 at the far-center end Twice of that, that is, the density of the mesh structure of the filter screen 11 at the proximal end is greater than the density of the mesh structure of the filter screen 12 at the distal end.
请再次参阅图1a及图1b,支撑段13包括六根长度相等的直杆131。每根直杆131均大致平行于滤器100的纵向中心轴并且沿滤器100的圆周方向均匀间隔分布。Please refer to FIG. 1a and FIG. 1b again, the support section 13 includes six straight rods 131 with equal lengths. Each straight rod 131 is substantially parallel to the longitudinal central axis of the filter 100 and is evenly spaced along the circumferential direction of the filter 100 .
可以理解的是,直杆131可以与近心端过滤网11和远心端过滤网12直接连接,直杆131也可以与近心端过滤网11和远心端过滤网12之间通过曲线段相连。It can be understood that the straight rod 131 can be directly connected with the filter screen 11 at the proximal end and the filter screen 12 at the distal end, and the straight rod 131 can also pass through a curved section between the filter screen 11 at the proximal end and the filter screen 12 at the distal end. connected.
每根直杆131沿滤器100的周向方向的宽度大于近心端过滤网11和远心端过滤网12的任一网线沿滤器100的周向方向的宽度。The width of each straight rod 131 along the circumferential direction of the filter 100 is greater than the width of any wire of the filter screen 11 at the proximal end and the filter screen 12 at the distal end along the circumferential direction of the filter 100 .
在本实施例中,每根直杆131沿滤器100的周向方向的宽度为0.8毫米,网线沿滤器100的周向方向的宽度为0.4毫米。In this embodiment, the width of each straight rod 131 along the circumferential direction of the filter 100 is 0.8 mm, and the width of the mesh wire along the circumferential direction of the filter 100 is 0.4 mm.
可以理解的是,其他实施例中,多根直杆131中可以有一根或者多根直杆被曲线型杆替换,只要滤器的近心端过滤网的锥度小于远心端过滤网的锥度即可。还可以理解的是,其他实施例中,多根直杆131中可以有至少一根直杆通过至少一根曲线型杆与近心端过滤网或者远心端过滤网相连,只要滤器的近心端过滤网的锥度小于远心端过滤网的锥度即可。还可以理解的是,其他实施例中,多根直杆131中也可以有一根直杆省略不要,此时,近心端过滤网的一根网线直接与远心心端过滤网的一根网线直接相连,只要滤器的近心端过滤网的锥度小于远心端过滤网的锥度即可。It can be understood that, in other embodiments, one or more of the straight rods 131 can be replaced by curved rods, as long as the taper of the filter screen at the proximal end of the filter is smaller than the taper of the filter screen at the distal end. . It can also be understood that, in other embodiments, at least one of the plurality of straight rods 131 can be connected to the filter screen at the proximal end or the filter screen at the distal end through at least one curved rod, as long as the proximal end of the filter The taper of the filter screen at the end is less than the taper of the filter screen at the far-center end. It can also be understood that, in other embodiments, one of the plurality of straight rods 131 can also be omitted. At this time, a network wire of the filter screen at the proximal end is directly connected to a network wire of the filter screen at the far-center end. Connected, as long as the taper of the filter screen at the proximal end of the filter is smaller than the taper of the filter screen at the distal end.
可以理解的是,其他实施例中,多根直杆131和曲线型杆可以间隔分布于滤器的圆周方向。还可以理解的是,其他实施例中,直杆131和曲线型杆也可以不间隔分布于滤器的圆周方向,例如全部直杆131可以顺序分布于滤器的圆周方向,全部曲线型杆可以跟随直杆131继续顺序分布于滤器的圆周方向,即曲线型杆可以随意排列于多根直杆131之间。It can be understood that, in other embodiments, a plurality of straight rods 131 and curved rods may be distributed at intervals in the circumferential direction of the filter. It can also be understood that, in other embodiments, the straight rods 131 and the curved rods can also be distributed in the circumferential direction of the filter without intervals, for example, all the straight rods 131 can be sequentially distributed in the circumferential direction of the filter, and all the curved rods can follow the straight The rods 131 are sequentially distributed in the circumferential direction of the filter, that is, the curved rods can be randomly arranged among a plurality of straight rods 131 .
同时应当理解,曲线型杆的结构可以包括一个或多个弯曲的波状线。请参阅图2,本实施例中回收钩20设置于主体部10的远心端102处,利用回收钩20与抓捕器(图未示)的连接可以将植入血管中的滤器100从血管中回收至体外。回收钩20为具有一开口的管状结构。回收钩20的开口方向沿滤器100的径向方向向外延伸且朝主体部10偏移,即回收钩20的开口方向与滤器100的纵向中心轴之间的夹角β小于90度。回收钩20的开口在垂直于开口方向上的宽度D大于或等于回收钩20的管状结构外径尺寸d的1/5,从而回收装置可以方便地抓捕回收钩20。回收钩20的开口在垂直于滤器100的纵向中心轴方向上的深度S小于或等于回收钩20的管状结构外径尺寸d的19/20,从而当回收装置抓捕回收钩20后,回收装置可以将回收钩20拉进回收鞘管。在本实施例中,回收钩20的开口在垂直于开口方向上的宽度D为1mm,回收钩20的开口在垂直于滤器100的纵向中心轴方向上的深度S为1.5mm。It should also be understood that the configuration of the curvilinear rod may include one or more curved wavy wires. Please refer to Fig. 2, in the present embodiment, the recovery hook 20 is arranged at the distal end 102 of the main body 10, and the filter 100 implanted in the blood vessel can be removed from the blood vessel by the connection between the recovery hook 20 and the catcher (not shown). recovered in vitro. The recovery hook 20 is a tubular structure with an opening. The opening direction of the recovery hook 20 extends outward along the radial direction of the filter 100 and deviates toward the main body 10 , that is, the angle β between the opening direction of the recovery hook 20 and the longitudinal central axis of the filter 100 is less than 90 degrees. The width D of the opening of the recovery hook 20 in the direction perpendicular to the opening is greater than or equal to 1/5 of the outer diameter d of the tubular structure of the recovery hook 20 , so that the recovery device can easily catch the recovery hook 20 . The depth S of the opening of the recovery hook 20 in the direction perpendicular to the longitudinal central axis of the filter 100 is less than or equal to 19/20 of the outer diameter d of the tubular structure of the recovery hook 20, so that when the recovery device catches the recovery hook 20, the recovery device The retrieval hook 20 can be pulled into the retrieval sheath. In this embodiment, the width D of the opening of the recovery hook 20 in the direction perpendicular to the opening is 1 mm, and the depth S of the opening of the recovery hook 20 in the direction perpendicular to the longitudinal central axis of the filter 100 is 1.5 mm.
当本实施例的滤器100在血管中受到血流高速冲刷时,滤器100可能会倾斜。但是由于靠近远心端102的远心端过滤网12的锥度大于靠近近心端101的近心端过滤网11的锥度,因此滤器100出现歪斜时近心端101会先接触血管壁,避免了位于远心端102处的回收钩20因接触血管壁而无法抓捕回收的风险。此外,当本实施例的滤器100在植入人体时,处于径向收缩状态的滤器100由鞘管中释放,先行释放的近心端过滤网11的径向支撑力稍小,因此释放速度缓慢,当发现释放位置不佳时可以将部分释放的近心端过滤网11收回鞘管,调整鞘管位置后再次释放,而缓慢释放的近心端过滤网11也会贴紧血管壁,保证了滤器100植入后的稳定性。When the filter 100 of this embodiment is scoured by high-speed blood flow in the blood vessel, the filter 100 may tilt. But because the taper of the far-end filter screen 12 near the far-center end 102 is greater than the taper of the proximal-end filter screen 11 near the proximal end 101, the proximal end 101 will contact the blood vessel wall first when the filter 100 is skewed, avoiding The recovery hook 20 located at the distal end 102 cannot grasp the risk of recovery due to contact with the vessel wall. In addition, when the filter 100 of this embodiment is implanted into the human body, the filter 100 in a radially contracted state is released from the sheath, and the radial support force of the proximal filter 11 that is released first is slightly smaller, so the release speed is slow , when it is found that the release position is not good, the partially released proximal filter 11 can be retracted into the sheath, and released again after adjusting the position of the sheath, and the slowly released proximal filter 11 will also stick to the blood vessel wall, ensuring Stability of filter 100 after implantation.
请参阅图3,本实施例中,滤器100还包括固定锚30。固定锚30设置于支撑段13的至少一根直杆131上,并与与其直接相连的直杆131之间的夹角α小于90度。固定锚30呈长条状,其一端固定在直杆131上,另一端为自由端且向近心端101的方向延伸。固定锚30的自由端至与其所在的固定锚30直接相连的直杆131的垂直距离小于或者等于3毫米。由此,当滤器100在血管内自然释放后,支撑段13的直杆131支撑着血管壁,固定锚30刺入血管壁,进一步地为滤器100提供可靠固定,防止滤器100在血管中产生移位。可以理解的是,一根直杆131上可以根据实际需要设置两个或者更多个固定锚30。可以理解的是,当支撑段13里面有曲线型杆时,固定锚30也可以根据实际需要设置于曲线型杆上。Please refer to FIG. 3 , in this embodiment, the filter 100 further includes a fixing anchor 30 . The fixing anchor 30 is arranged on at least one straight rod 131 of the supporting section 13, and the included angle α between the straight rod 131 directly connected with it is smaller than 90 degrees. The fixing anchor 30 is in the shape of a strip, one end of which is fixed on the straight rod 131 , and the other end is a free end extending toward the proximal end 101 . The vertical distance from the free end of the fixed anchor 30 to the straight rod 131 directly connected with the fixed anchor 30 is less than or equal to 3 millimeters. Thus, when the filter 100 is naturally released in the blood vessel, the straight rod 131 of the support section 13 supports the blood vessel wall, and the anchor 30 penetrates into the blood vessel wall to further provide reliable fixation for the filter 100 and prevent the filter 100 from migrating in the blood vessel. bit. It can be understood that two or more fixed anchors 30 can be arranged on one straight rod 131 according to actual needs. It can be understood that when there is a curved rod inside the support section 13, the anchor 30 can also be arranged on the curved rod according to actual needs.
请参阅图4,本实施例的滤器100在血管中受到血流高速冲刷时,滤器100可能会倾斜。但是由于靠近远心端102的远心端过滤网12锥度大于靠近近心端101的近心端过滤网11锥度,远心端过滤网12的径向支撑力较大,利于固定锚30远离远心端102的自由端刺入血管壁。当滤器100受到血流冲刷时,滤器100仅会绕着固定锚30小角度旋转,而不移位,保证了滤器100植入后的稳定性。Please refer to FIG. 4 , when the filter 100 of this embodiment is scoured by high-speed blood flow in the blood vessel, the filter 100 may tilt. But because the taper of the far-end filter screen 12 near the far-center end 102 is greater than the taper of the near-heart end filter screen 11 near the proximal end 101, the radial support force of the far-center end filter screen 12 is larger, which is beneficial to the fixed anchor 30 away from the far-end filter screen. The free end of the heart tip 102 penetrates the vessel wall. When the filter 100 is washed by the blood flow, the filter 100 will only rotate around the fixed anchor 30 at a small angle without displacement, which ensures the stability of the filter 100 after implantation.
滤器100采用输送鞘管经皮穿刺股静脉植入下腔静脉中,通过X射线显影设备检测出滤器100在植入下腔静脉后,没有产生倾斜、移位或翻转。滤器100植入14天后取出,患者未出现腹痛等不适症状,即滤器100取出时未对血管内壁造成损伤。The filter 100 is implanted into the inferior vena cava by percutaneously puncturing the femoral vein with a delivery sheath, and it is detected by X-ray imaging equipment that the filter 100 does not tilt, shift or turn over after being implanted in the inferior vena cava. The filter 100 was taken out 14 days after implantation, and the patient did not experience abdominal pain and other discomfort symptoms, that is, the filter 100 did not cause damage to the inner wall of the blood vessel when it was taken out.
实施例二Embodiment two
请参阅图5a,本实施例的滤器200的结构与实施例一的滤器100的结构大致相同。滤器200包括主体部40和设置于主体部40一端的回收钩50以及固定锚60。主体部40具有相对的近心端401和远心端402,其包括靠近近心端401的近心端过滤网41、靠近远心端402的远心端过滤网42及连接于近心端过滤网41与远心端过滤网42之间的支撑段43。滤器200与滤器100的区别之处在于:远心端过滤网42的结构不同于远心端过滤网12的结构。Referring to FIG. 5 a , the structure of the filter 200 of this embodiment is substantially the same as that of the filter 100 of the first embodiment. The filter 200 includes a main body 40 , a recovery hook 50 and a fixing anchor 60 disposed at one end of the main body 40 . The main body 40 has a proximal end 401 and a distal end 402 opposite, which include a proximal filter 41 near the proximal end 401, a distal filter 42 near the far end 402, and a filter connected to the proximal end. The support section 43 between the net 41 and the filter net 42 at the distal end. The difference between the filter 200 and the filter 100 is that the structure of the filter 42 at the distal end is different from the structure of the filter 12 at the distal end.
请同时参阅图5b、图5c和和图5d,本实施例的远心端过滤网42与第一实施例的远心端过滤网42的区别在于,远心端过滤网42包括六条直线型的第五网线421,六条第五网线421靠近远心端402的端部在远心端402处汇聚。由此,当滤器200自然释放后,远心端过滤网42具有空间锥形结构。每条第五网线421在远心端402处形成的夹角相等。每条第五网线421的远离远心端402的端部均与近心端过滤网41相连。Please refer to Fig. 5b, Fig. 5c and Fig. 5d at the same time, the difference between the far-end filter net 42 of the present embodiment and the far-central end filter net 42 of the first embodiment is that the far-central end filter net 42 comprises six linear The fifth network cable 421 , the ends of the six fifth network cables 421 near the distal end 402 converge at the distal end 402 . Therefore, when the filter 200 is released naturally, the filter screen 42 at the distal end has a spatially tapered structure. The included angles formed by each of the fifth mesh wires 421 at the distal end 402 are equal. The end of each fifth mesh wire 421 away from the distal end 402 is connected to the filter screen 41 at the proximal end.
每条第五网线421可分别呈直线型,也可呈曲线型,还可部分呈曲线型,其余部分呈直线型。Each of the fifth network cables 421 can be straight or curved, or partially curved and the rest are straight.
滤器200采用输送鞘管经皮穿刺股静脉植入下腔静脉中,通过X射线显影设备检测出滤器200在植入下腔静脉后,没有产生倾斜、移位或翻转。滤器200植入14天后取出,患者未出现腹痛等不适症状,即滤器200取出时未对血管内壁造成损伤。The filter 200 is implanted into the inferior vena cava by percutaneously puncturing the femoral vein with a delivery sheath, and it is detected by X-ray imaging equipment that the filter 200 does not tilt, shift or turn over after being implanted in the inferior vena cava. The filter 200 was taken out 14 days after implantation, and the patient did not experience discomfort such as abdominal pain, that is, the filter 200 did not cause damage to the inner wall of the blood vessel when it was taken out.
可以理解的是,当本发明的滤器采用外径尺寸为d的镍钛管切割、定型制备时,可以在同一根镍钛管上切割形成近心端过滤网和远心端过滤网的多条网线和支撑段的直杆。每根直杆沿滤器的周向方向的宽度小于镍钛管的外径尺寸d的1/2,且直杆沿滤器的周向方向的宽度大于组成近心端过滤网和远心端过滤网的网线的曲线段和/或直线段沿滤器的周向方向的宽度。It can be understood that when the filter of the present invention is prepared by cutting and shaping a nickel-titanium tube with an outer diameter of d, it is possible to cut and form a plurality of filter screens at the proximal end and the filter screen at the distal end on the same nickel-titanium tube. Straight rods for network cables and support segments. The width of each straight rod along the circumferential direction of the filter is less than 1/2 of the outer diameter d of the nickel-titanium tube, and the width of the straight rod along the circumferential direction of the filter is greater than that of the proximal filter and the distal filter. The width of the curved segment and/or straight segment of the mesh wire along the circumferential direction of the filter.
当滤器采用外径尺寸为d的镍钛管切割、定型而成时,回收钩可以与滤器的主体部一体成型,即回收钩可以直接在镍钛管的端部切割一开口而成。当滤器采用镍钛丝或镍钛扁带通过编织、定型而成时,回收钩也可以为一具有开口且外径尺寸为d的镍钛管,其可以与滤器的主体部的近心端或远心端通过焊接的方式连接为一体。When the filter is cut and shaped from a nickel-titanium tube with an outer diameter of d, the recovery hook can be integrally formed with the main body of the filter, that is, the recovery hook can be formed by directly cutting an opening at the end of the nickel-titanium tube. When the filter adopts nickel-titanium wire or nickel-titanium flat belt by weaving and shaping, the recovery hook can also be a nickel-titanium tube with an opening and an outer diameter of d, which can be connected to the proximal end or the main body of the filter. The distal end is connected as a whole by welding.
也应当理解,回收钩也可以根据实际需要设置于主体部的近心端处,只要输送滤器的输送装置可以将滤器放于血管的预定位置处,且回收滤器的回收装置可以连接回收钩,并将滤器回收并退出血管即可。It should also be understood that the recovery hook can also be arranged at the proximal end of the main body according to actual needs, as long as the delivery device for delivering the filter can place the filter at a predetermined position in the blood vessel, and the recovery device for recovering the filter can be connected to the recovery hook, and Retrieve the filter and exit the blood vessel.
可以理解的是,本发明的滤器还可以采用其他超弹性材料(例如,不锈钢丝、钴-铬-镍-钼-铁合金、钴-铬合金或聚合物)制成,也可以由具有自膨胀的任何其它合适材料形成。It can be understood that the filter of the present invention can also be made of other superelastic materials (for example, stainless steel wire, cobalt-chromium-nickel-molybdenum-iron alloy, cobalt-chromium alloy or polymer), and can also be made of self-expanding Any other suitable material.
综上所述,本发明的滤器植入至人体血管,并在血管中自然释放后,靠近滤器近心端的近心端过滤网的锥度小于靠近滤器远心端的远心端过滤网的锥度,近心端过滤网的径向支撑力小于远心端过滤网的径向支撑力。与现有技术相比,本发明的滤器的优点是:1)待栓子被拦截于近心端过滤网时,近心端过滤网的径向支撑力增大,缩小了近心端过滤网的径向支撑力与远心端过滤网的径向支撑力之间的差距,减小了滤器歪斜的可能,提高了滤器过滤栓子的效率,减低了术后病患再次栓塞的风险;2)在回收钩设于远心端处的滤器被植入人体时,处于径向收缩状态的滤器由鞘管中释放,先行释放的近心端过滤网的径向支撑力稍小,因此释放速度缓慢,当发现释放位置不佳时可以将部分释放的近心端过滤网收回鞘管,调整鞘管位置后再次释放,而缓慢释放的近心端过滤网也会贴紧血管壁,保证了滤器植入后的稳定性;3)远心端过滤网的径向支撑力稍大,滤器释放时会由鞘管中快速弹出,固定锚会受到更大的反弹力,固定锚的自由端刺入血管的力度更大,保证了滤器植入后的稳定性;4)近心端过滤网长度大于远心端过滤网长度,可以使多个血栓有序地进入近心端过滤网,避免了多个血栓在近心端过滤网入口处引起涡流的情况的发生,也就避免了涡流对滤器主体产生冲击的情况的发生,减小了滤器歪斜的可能;5)近心端过滤网包括多个尺寸适中的菱形过滤单元,多个尺寸适中的菱形过滤单元既能充分过滤血栓,也避免了由于大小血栓均被拦截造成血管阻塞的情况的发生,保证了静脉的长期通畅。In summary, after the filter of the present invention is implanted into a human blood vessel and released naturally in the blood vessel, the taper of the filter screen at the proximal end near the proximal end of the filter is smaller than that of the filter screen at the distal end near the distal end of the filter. The radial support force of the filter screen at the central end is smaller than the radial support force of the filter screen at the distal end. Compared with the prior art, the advantages of the filter of the present invention are: 1) When the emboli are intercepted in the filter screen at the proximal end, the radial support force of the filter screen at the proximal end increases, reducing the size of the filter screen at the proximal end. The gap between the radial support force of the radial support force and the radial support force of the filter at the distal end reduces the possibility of filter skew, improves the efficiency of the filter for filtering emboli, and reduces the risk of re-embolization of patients after surgery; 2 ) When the filter with the recovery hook set at the distal end is implanted into the human body, the filter in the radially contracted state is released from the sheath, and the radial support force of the filter screen at the proximal end that is released first is slightly smaller, so the release speed Slowly, when it is found that the release position is not good, you can retract the partially released filter at the proximal end of the sheath, adjust the position of the sheath and release it again, and the filter at the proximal end that is slowly released will also stick to the blood vessel wall, ensuring that the filter Stability after implantation; 3) The radial support force of the filter at the distal end is slightly larger. The strength of the blood vessel is greater, which ensures the stability of the filter after implantation; 4) The length of the filter screen at the proximal end is greater than the length of the filter screen at the distal end, so that multiple thrombus can enter the filter screen at the proximal end in an orderly manner, avoiding multiple A thrombus causes eddy currents at the inlet of the filter screen at the proximal end, which avoids the impact of the vortex on the filter body and reduces the possibility of filter skew; 5) The filter screen at the proximal end includes multiple Moderately sized diamond-shaped filter unit, multiple moderately sized diamond-shaped filter units can not only fully filter thrombus, but also avoid the occurrence of blood vessel blockage due to the interception of large and small thrombus, ensuring long-term patency of veins.
对比例一Comparative example one
对比例一的滤器的结构与实施例一的滤器100的结构大致相同,其包括靠近近心端的近心端过滤网、靠近远心端的远心端过滤网及连接于近心端过滤网及远心端过滤网之间的支撑段。区别之处在于,当对比例一的滤器在血管中自然释放后,近心端过滤网的锥度大于远心端过滤网的锥度。The structure of the filter of Comparative Example 1 is substantially the same as that of the filter 100 of Embodiment 1, which includes a proximal filter near the proximal end, a distal filter near the far end, and a filter connected to the proximal filter and the distal end. Support segment between end filters. The difference is that, after the filter of Comparative Example 1 is naturally released in the blood vessel, the taper of the filter screen at the proximal end is greater than that of the filter screen at the distal end.
对比例一的滤器采用输送鞘管经皮穿刺股静脉植入下腔静脉中。由于近心端过滤网的锥度大于远心端过滤网的锥度,因此近心端过滤网的径向支撑力大于远心端过滤网的径向支撑力。而在植入后,近心端过滤网拦截下血液中的栓子,这种差距逐渐增大,最终导致滤器歪斜,影响了滤器的过滤效率;并且,由于滤器发生歪斜,导致部分固定锚的自由端和血管壁接触的位置不稳定,在呼吸时,由于腹腔压力的变化,固定锚多次刺入和拔出血管壁,导致该位置血管被刺破,患者出现腹痛等不适症状。经显影设备检测,患者发生腹部血肿,滤器被提前取出,没有达到预期的治疗效果。The filter of Comparative Example 1 was implanted into the inferior vena cava by percutaneously puncturing the femoral vein with a delivery sheath. Since the taper of the filter screen at the proximal end is greater than the taper of the filter screen at the distal end, the radial support force of the filter screen at the proximal end is greater than the radial support force of the filter screen at the distal end. However, after implantation, the filter at the proximal end intercepts the emboli in the blood, and this gap gradually increases, eventually causing the filter to be skewed, which affects the filtration efficiency of the filter; and, due to the skew of the filter, part of the fixed anchor is lost. The contact position between the free end and the vessel wall is unstable. During breathing, due to changes in abdominal pressure, the anchor penetrates and pulls out of the vessel wall many times, causing the vessel to be punctured at this position, and the patient suffers from abdominal pain and other discomfort. After detection by imaging equipment, the patient developed abdominal hematoma, and the filter was removed in advance, which did not achieve the expected therapeutic effect.
请参阅图6,经显影设备检测,在下腔静脉的该滤器未取出前的植入位置处,下腔静脉的血管壁被刺破后血液外流形成血肿。由此可知,本对比例的滤器在植入后对血管造成了损伤。Please refer to FIG. 6 , as detected by the imaging device, at the implantation position of the inferior vena cava before the filter is taken out, the blood vessel wall of the inferior vena cava is punctured and blood flows out to form a hematoma. It can be seen that the filter of this comparative example caused damage to blood vessels after implantation.
以上结合附图对本发明的实施例进行了描述,但是本发明并不局限于上述的具体实施方式,上述的具体实施方式仅仅是示意性的,而不是限制性的,本领域的普通技术人员在本发明的启示下,在不脱离本发明宗旨和权利要求所保护的范围情况下,还可做出很多形式,这些均属于本发明的保护之内。The embodiments of the present invention have been described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific embodiments, which are only illustrative, rather than restrictive, and those of ordinary skill in the art will Under the enlightenment of the present invention, many forms can also be made without departing from the gist of the present invention and the protection scope of the claims, and these all belong to the protection of the present invention.
Claims (18)
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201511024970.6A CN105662646A (en) | 2015-12-29 | 2015-12-29 | Filter |
| PCT/CN2016/086117 WO2017113633A1 (en) | 2015-12-29 | 2016-06-17 | Filter |
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| CN201511024970.6A CN105662646A (en) | 2015-12-29 | 2015-12-29 | Filter |
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| CN105662646A true CN105662646A (en) | 2016-06-15 |
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| CN201511024970.6A Pending CN105662646A (en) | 2015-12-29 | 2015-12-29 | Filter |
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| WO (1) | WO2017113633A1 (en) |
Cited By (9)
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| WO2017113633A1 (en) * | 2015-12-29 | 2017-07-06 | 先健科技(深圳)有限公司 | Filter |
| CN107374777A (en) * | 2017-08-25 | 2017-11-24 | 重庆医科大学附属第二医院 | It is a kind of be easily recycled and safety interim Vena cava filter |
| WO2018082378A1 (en) * | 2016-11-02 | 2018-05-11 | 先健科技(深圳)有限公司 | Filter |
| WO2018099147A1 (en) * | 2016-12-01 | 2018-06-07 | 先健科技(深圳)有限公司 | Filter |
| CN108143517A (en) * | 2016-12-06 | 2018-06-12 | 先健科技(深圳)有限公司 | Filter |
| CN108143518A (en) * | 2016-12-06 | 2018-06-12 | 先健科技(深圳)有限公司 | Filter |
| CN110226989A (en) * | 2019-06-24 | 2019-09-13 | 内蒙古工业大学 | A kind of eddy current type vena cava filter and biofilter system |
| CN111412498A (en) * | 2019-01-04 | 2020-07-14 | 宁波方太厨具有限公司 | Folding filter screen for range hood |
| CN114681107A (en) * | 2020-12-25 | 2022-07-01 | 深圳市科奕顿生物医疗科技有限公司 | An implantable lumen filter |
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| CN113633431A (en) * | 2020-05-11 | 2021-11-12 | 上海蓝脉医疗科技有限公司 | Filter device |
| CN113940783A (en) * | 2020-07-15 | 2022-01-18 | 先健科技(深圳)有限公司 | thrombus blocking device |
| CN113940784A (en) * | 2020-07-15 | 2022-01-18 | 先健科技(深圳)有限公司 | Thrombus interception instrument |
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| CN114681107A (en) * | 2020-12-25 | 2022-07-01 | 深圳市科奕顿生物医疗科技有限公司 | An implantable lumen filter |
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| WO2017113633A1 (en) | 2017-07-06 |
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