CN100348281C - Large-radical-support-force medical stent - Google Patents

Large-radical-support-force medical stent Download PDF

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CN100348281C
CN100348281C CNB2005100376133A CN200510037613A CN100348281C CN 100348281 C CN100348281 C CN 100348281C CN B2005100376133 A CNB2005100376133 A CN B2005100376133A CN 200510037613 A CN200510037613 A CN 200510037613A CN 100348281 C CN100348281 C CN 100348281C
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stent
shaped
sinusoidal
large radial
circular ring
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CN1640506A (en
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储成林
林萍华
浦跃朴
王世栋
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Southeast University
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Abstract

The present invention relates to a medical support frame with large radical support force, which is formed by etching by metal tubes and is in a tubular net-shaped structure. The support frame is composed of a plurality of axially-distributed basic structures (1) in the shape of sine waves and circular rings, wherein wave crests of sine waves are opposite to each other between every two adjacent basic structures (1) in the shape of sine waves and are connected with each other by X-shaped connecting members (2); connecting points (3) are arranged among the wave crests and the wave troughs of the basic structures (1) in the shape of sine waves and circular rings, and the rib width (5) of the X-shaped connecting members (2) is smaller than or equal to the rib width (4) of the basic structures (1) in the shape of sine waves and circular rings. The end of the support frame in cavity channels can be manufactured into a horn mouth shape, the inner surface and the outer surface of the support frame can be covered with metal films, oxide films, polymer films or slow-release medicine films, and the materials for etching the metal tubes of the support frame in the cavity channels can be nickel-titanium alloy, stainless steel, titanium alloy, pure metal tantalum or gold, etc. The present invention has the advantages of large radical support force, stable structure, etc.

Description

大径向支撑力医用支架Large radial support force medical stent

技术领域technical field

本发明涉及一种大径向支撑力医用支架,用于扩张和支撑狭窄的血管、食管、胆管、肠道或尿道等人体内管腔道,属于医疗器材制造的技术领域。The invention relates to a medical stent with a large radial support force, which is used for expanding and supporting narrow blood vessels, esophagus, bile duct, intestinal tract or urethra, etc., and belongs to the technical field of medical equipment manufacturing.

背景技术Background technique

血管栓塞、食管癌、前列腺增生和胆道结石是生活中常见的管腔梗阻性疾病,临床上可采用开放性手术治疗,不仅手术操作难度大,并且存在一些难以解决的问题,如并发症多、危险性大、复发率高等,这就需要一种更为简便、安全有效的方法来解决以上难点,利用内支架的介入是一种行之有效的方法。腔道内支架是一种常用的器械,具有各种形状,管状是最常见的。现有的人体腔道用内支架多为网格状或螺旋丝状结构,植入人体后,用来扩张和支撑狭窄的血管、食道、胆道、肠道及尿管等人体内管腔道,解除腔道梗阻,保持腔道畅通,操作简便,疗效可靠,并发症少。然而,现有支架还存在一些缺陷,例如,常用的非血管腔道内支架多采用丝材编织,呈管形网格状,这样的支架有金属材料的重叠点,使体液的流动性能变差,且支架的径向支撑力不足,可调整范围较小。常用的血管支架也多存在支架的径向支撑力较小,结构稳定性较差等缺点。因此对满足手术要求的大径向支撑力医用支架的设计和制作有更进一步的要求。Vascular embolism, esophageal cancer, benign prostatic hyperplasia, and biliary tract stones are common luminal obstructive diseases in daily life. Open surgery can be used for clinical treatment. Not only is the operation difficult, but there are also some difficult problems to solve, such as many complications, The high risk and high recurrence rate require a more convenient, safe and effective method to solve the above difficulties, and the use of internal stent intervention is an effective method. Intraluminal stents are a commonly used device and come in various shapes, with tubular being the most common. Most of the existing internal stents for human cavity are grid-like or spiral filament-like structures, which are used to expand and support narrow blood vessels, esophagus, biliary tract, intestinal tract, urinary catheter and other human body lumens after being implanted in the human body. It relieves cavity obstruction, keeps the cavity unobstructed, is easy to operate, reliable in curative effect, and has few complications. However, there are still some defects in the existing stents. For example, the commonly used non-vascular intraluminal stents are mostly braided with silk, which is in the shape of a tubular grid. Such stents have overlapping points of metal materials, which makes the fluidity of body fluids worse. Moreover, the radial support force of the bracket is insufficient, and the adjustable range is small. Commonly used vascular stents also have disadvantages such as small radial support force of the stent and poor structural stability. Therefore, there are further requirements for the design and manufacture of medical stents with large radial support force that meet the surgical requirements.

发明内容Contents of the invention

技术问题:本发明的发明目的就在于改变目前使用的大径向支撑力医用支架的不足,提供一种具有径向支撑力大,结构稳定性好等优点,具有管状网形结构的大径向支撑力医用支架。Technical problem: The purpose of the invention is to change the deficiency of the large radial support force medical stent currently used, and provide a large radial support force with a large radial support force, good structural stability, etc., with a tubular mesh structure. Support force medical bracket.

技术方案:本发明的大径向支撑力医用支架,是由金属管刻蚀而成,呈管状网形结构,该支架由沿其轴向分布的多个正弦波形圆环状基本结构构成,每相邻的两个正弦波形圆环状基本结构之间,正弦波的波峰相对,并通过“X”形连接件连接,连结点选在正弦波形圆环状基本结构的波峰与波谷之间。Technical solution: The medical stent with large radial support force of the present invention is etched from a metal tube and has a tubular mesh structure. Between two adjacent sine wave circular basic structures, the crests of the sine waves face each other and are connected by an "X" shaped connector, and the connection point is selected between the crests and troughs of the sine wave circular basic structures.

上述大径向支撑力医用支架,其特征在于每相邻两个正弦波形圆环状基本结构之间,“X”形连接件呈等间距分布,该间距为正弦波形圆环状基本结构的正弦波波长的整数倍,该整数为1或2或3等。“X”形连接件的筋宽度应小于或等于正弦波形圆环状基本结构的筋宽度。The above-mentioned medical stent with large radial support force is characterized in that between every two adjacent sinusoidal circular ring-shaped basic structures, the "X"-shaped connectors are distributed at equal intervals, and the distance is the sine of the sinusoidal circular circular basic structure. An integer multiple of the wavelength of a wave, the integer is 1 or 2 or 3, etc. The rib width of the "X"-shaped connector should be less than or equal to the rib width of the sinusoidal circular ring-shaped basic structure.

本发明在用于血管狭窄部位的扩张与支撑作用时,其外径为1~20mm,总长为5~150mm,壁厚为0.02~0.4mm,正弦波形圆环状基本结构的正弦波周期的数目为6~36个,其整体宽度为0.5~10mm,其筋宽度为0.06~0.6mm。When the present invention is used for expansion and support of vascular stenosis, the outer diameter is 1-20mm, the total length is 5-150mm, the wall thickness is 0.02-0.4mm, and the number of sine wave cycles of the sinusoidal ring-shaped basic structure There are 6-36 pieces, the overall width is 0.5-10mm, and the rib width is 0.06-0.6mm.

本发明在用于人体内非血管腔道狭窄部位的扩张与支撑作用时,其外径为6~25mm,总长为50~140mm,壁厚为0.1~0.5mm,正弦波形圆环状基本结构的正弦波周期的数目为6~30个,其整体宽度为1.0~10mm,其筋宽度为0.15~0.7mm。When the present invention is used for the expansion and support of non-vascular stenosis parts in the human body, its outer diameter is 6-25 mm, its total length is 50-140 mm, its wall thickness is 0.1-0.5 mm, and it has a sinusoidal circular ring-shaped basic structure. The number of sine wave periods is 6-30, the overall width is 1.0-10mm, and the rib width is 0.15-0.7mm.

本发明端部可以做成喇叭口型。其内外表面可以覆盖金属膜、氧化物膜、高分子膜或缓释药物膜。刻蚀本发明的金属管的材质可以是镍钛合金、不锈钢、钛合金及纯金属钽或金等,其中,采用镍钛合金管刻蚀的本发明为自膨胀式支架,采用不锈钢管、钛合金管、钽金属管或金金属管刻蚀的本发明为球囊扩张式支架。The end of the present invention can be made into a trumpet shape. Its inner and outer surfaces can be covered with metal film, oxide film, polymer film or slow-release medicine film. The metal tube of the present invention can be etched with materials such as nickel-titanium alloy, stainless steel, titanium alloy and pure metal tantalum or gold, etc., wherein, the present invention that adopts nickel-titanium alloy tube etching is a self-expanding stent, and adopts stainless steel tube, titanium alloy The present invention etched by tube, tantalum metal tube or gold metal tube is a balloon-expandable stent.

本发明具有正弦波形圆环状基本结构,并通过“X”形连接件连接,每个“X”形连接件与周围的正弦波形圆环状基本结构之间有4个对称分布的连结点,这就使得该支架在手术安装及使用过程中具有很好的结构稳定性,较大的径向支撑力,且支架表面平整、结构连续、易抛光、无金属材料的重叠点。The present invention has a sinusoidal circular ring-shaped basic structure, which is connected by an "X"-shaped connector, and there are four symmetrically distributed connection points between each "X"-shaped connector and the surrounding sinusoidal circular ring-shaped basic structure. This makes the bracket have good structural stability and large radial support force during surgical installation and use, and the bracket has a smooth surface, continuous structure, easy polishing, and no overlapping points of metal materials.

附图说明Description of drawings

图1是本发明实施例1支架的展开示意图。Fig. 1 is a schematic diagram of the deployment of the stent according to Example 1 of the present invention.

图2是本发明实施例2支架的展开示意图。Fig. 2 is a schematic diagram of the deployment of the stent of Example 2 of the present invention.

图3是本发明的径向截面示意图。Fig. 3 is a schematic radial cross-sectional view of the present invention.

其中的附图标记为:1—正弦波形圆环状基本结构,2—“X”形连接件,3—连结点,4—正弦波形圆环状基本结构1的筋宽度,5—“X”形连接件2的筋宽度,6—正弦波的波长,7—正弦波的振幅,8—整体宽度,9—相邻两个正弦波形圆环状基本结构1之间的间距,10—相邻“X”形连接件2之间的间距,11—支架的外径,12—支架的壁厚,13—支架的总长。The reference signs therein are: 1—sinusoidal circular ring-shaped basic structure, 2—“X”-shaped connector, 3—joint point, 4—sinusoidal circular ring-shaped basic structure 1 rib width, 5—“X” The rib width of the shaped connector 2, 6—the wavelength of the sine wave, 7—the amplitude of the sine wave, 8—the overall width, 9—the distance between two adjacent sinusoidal wave ring-shaped basic structures 1, 10—adjacent The distance between the "X"-shaped connectors 2, 11—the outer diameter of the bracket, 12—the wall thickness of the bracket, and 13—the total length of the bracket.

具体实施方式Detailed ways

下面,结合附图与实施例对本发明作进一步的说明。Below, the present invention will be further described in conjunction with the accompanying drawings and embodiments.

实施例1Example 1

参见图1,一种人体内血管用管状支架,是由超弹性镍钛合金管刻蚀而成,呈管状网形结构,该支架由沿其轴向分布的多个正弦波形圆环状基本结构1构成,每相邻的两个正弦波形圆环状基本结构1之间,正弦波的波峰相对,并通过“X”形连接件2连接,连结点3选在正弦波形圆环状基本结构1的波峰与波谷中间位置。每相邻两个正弦波形圆环状基本结构1之间,“X”形连接件2呈等间距分布,该间距10为正弦波形圆环状基本结构1的正弦波波长6的1倍。“X”形连接件2的筋宽度5小于正弦波形圆环状基本结构1的筋宽度4。Referring to Figure 1, a tubular stent for blood vessels in the human body is etched from a superelastic nickel-titanium alloy tube and has a tubular network structure. 1, between each two adjacent sinusoidal circular ring-shaped basic structures 1, the crests of the sine waves face each other, and are connected by an "X"-shaped connector 2, and the connection point 3 is selected at the sinusoidal circular ring-shaped basic structure 1 The middle position between the peak and the trough. Between every two adjacent sinusoidal ring-shaped basic structures 1 , the "X"-shaped connectors 2 are distributed at equal intervals, and the distance 10 is one time of the sine wave wavelength 6 of the sinusoidal ring-shaped basic structures 1 . The rib width 5 of the "X"-shaped connector 2 is smaller than the rib width 4 of the sinusoidal circular ring-shaped basic structure 1 .

本实施例支架的外径11为2.38mm,总长13为19.715mm,壁厚12为0.1mm,展开宽度为7.459mm,正弦波形圆环状基本结构1的正弦波周期的数目为6个,其整体宽度8为1.735mm,其筋宽度4为0.12mm,正弦波形圆环状基本结构1的正弦波的振幅7为0.868mm,其波长6为1.243mm,相邻两个正弦波形圆环状基本结构1之间的间距9为2mm,“X”形连接件2的筋宽度5为0.1mm,相邻两个“X”形连接件2之间的间距10为1.243mm。The outer diameter 11 of the stent in this embodiment is 2.38 mm, the total length 13 is 19.715 mm, the wall thickness 12 is 0.1 mm, and the expanded width is 7.459 mm. The overall width 8 is 1.735mm, the rib width 4 is 0.12mm, the amplitude 7 of the sine wave of the sinusoidal circular ring-shaped basic structure 1 is 0.868mm, and its wavelength 6 is 1.243mm. The spacing 9 between the structures 1 is 2 mm, the rib width 5 of the "X"-shaped connector 2 is 0.1 mm, and the spacing 10 between two adjacent "X"-shaped connectors 2 is 1.243 mm.

本实施例为自膨胀式血管用管状支架,手术时将本发明约束在导管内,当植入到人体内血管狭窄部位后,去除约束导管,本发明因具有良好的超弹性而自行膨胀,起到对狭窄血管的扩张和支撑作用,达到治疗目的。This embodiment is a self-expanding tubular stent for blood vessels. During the operation, the invention is constrained in the catheter. After being implanted into the narrowed part of the blood vessel in the human body, the restraining catheter is removed. The invention will self-expand due to its good superelasticity. To expand and support the stenotic blood vessels, to achieve the purpose of treatment.

该腔道内支架端部还可做成喇叭口型。该腔道内支架内外表面还可覆盖金属膜、氧化物膜、高分子膜或缓释药物膜。刻蚀该腔道内支架的金属管的材质还可是不锈钢、或钛合金、或纯金属钽或金。The end of the bracket in the cavity can also be made into a trumpet shape. The inner and outer surfaces of the stent in the cavity can also be covered with metal film, oxide film, polymer film or slow-release drug film. The material of the metal tube for etching the stent in the lumen can also be stainless steel, or titanium alloy, or pure metal tantalum or gold.

实施例2Example 2

参见图2,人体内血管用管状支架,是由超弹性镍钛合金管刻蚀而成,呈管状网形结构,该血管用管状支架由沿其轴向分布的多个正弦波形圆环状基本结构1构成,每相邻的两个正弦波形圆环状基本结构1之间,正弦波的波峰相对,并通过“X”形连接件2连接,连结点3选在正弦波形圆环状基本结构1的波峰与波谷中间位置。每相邻两个正弦波形圆环状基本结构1之间,“X”形连接件2呈等间距分布,该间距10为3.729mm,是正弦波形圆环状基本结构1的正弦波波长6的3倍。“X”形连接件2的筋宽度5小于正弦波形圆环状基本结构1的筋宽度4。本实施例的其它结构与尺寸特征、制造方法均与实施例1相同。Referring to Figure 2, the tubular stent for blood vessels in the human body is etched from a superelastic nickel-titanium alloy tube and has a tubular network structure. The structure 1 is composed of two adjacent sinusoidal circular ring-shaped basic structures 1. The crests of the sine waves are opposite and connected by "X"-shaped connectors 2. The connection point 3 is selected in the sinusoidal circular ring-shaped basic structure. 1 in the middle of the peak and trough. Between every two adjacent sinusoidal circular ring-shaped basic structures 1, the "X"-shaped connectors 2 are distributed at equal intervals. 3 times. The rib width 5 of the "X"-shaped connector 2 is smaller than the rib width 4 of the sinusoidal circular ring-shaped basic structure 1 . Other structures, dimensions, and manufacturing methods of this embodiment are the same as those of Embodiment 1.

Claims (9)

1、一种大径向支撑力医用支架,由金属管刻蚀而成,呈管状网形结构,其特征在于该支架由沿其轴向分布的多个正弦波形圆环状基本结构(1)构成,每相邻的两个正弦波形圆环状基本结构(1)之间,通过“X”形连接件(2)连接;每相邻两个正弦波形圆环状基本结构(1)的正弦波波峰相对;正弦波形圆环状基本结构(1)与“X”形连接件(2)的连结点(3)选在所述正弦波形圆环状基本结构(1)的波峰与波谷之间。1. A medical stent with a large radial support force, which is etched from a metal tube and has a tubular network structure, is characterized in that the stent consists of a plurality of sinusoidal circular ring-shaped basic structures distributed along its axial direction (1) Composition, every two adjacent sinusoidal waveform circular basic structures (1) are connected by an "X"-shaped connector (2); the sine of each adjacent two sinusoidal circular circular basic structures (1) The wave crests are opposite; the connection point (3) between the sinusoidal circular ring-shaped basic structure (1) and the "X"-shaped connector (2) is selected between the crest and the trough of the sinusoidal circular circular basic structure (1) . 2、根据权利要求1所述的大径向支撑力医用支架,其特征在于所述正弦波形圆环状基本结构(1)与“X”形连接件(2)的连结点(3)选在所述正弦波形圆环状基本结构(1)的波峰与波谷中间位置。2. The medical stent with large radial supporting force according to claim 1, characterized in that the connection point (3) between the sinusoidal circular ring-shaped basic structure (1) and the "X"-shaped connector (2) is selected at The intermediate position between the crest and the trough of the circular basic structure (1) of sinusoidal waveform. 3、根据权利要求1所述的大径向支撑力医用支架,其特征在于每相邻两个正弦波形圆环状基本结构(1)之间,“X”形连接件(2)呈等间距分布,该间距(10)为正弦波形圆环状基本结构(1)的正弦波波长(6)的整数倍。3. The medical stent with large radial supporting force according to claim 1, characterized in that between every two adjacent sinusoidal circular ring-shaped basic structures (1), the "X" shaped connectors (2) are equidistant distribution, the spacing (10) is an integer multiple of the sine wave wavelength (6) of the sine wave circular ring-shaped basic structure (1). 4、根据权利要求1所述的大径向支撑力医用支架,其特征在于“X”形连接件(2)的筋宽度(5)小于或等于正弦波形圆环状基本结构(1)的筋宽度(4)。4. The medical stent with large radial supporting force according to claim 1, characterized in that the rib width (5) of the "X"-shaped connector (2) is less than or equal to the rib of the sinusoidal circular ring-shaped basic structure (1) width (4). 5、根据权利要求1所述的大径向支撑力医用支架,其特征在于该支架用于血管狭窄部位的扩张与支撑作用时,其外径(11)为1~20mm,总长(13)为5~150mm,壁厚(12)为0.02~0.4mm,正弦波形圆环状基本结构(1)的正弦波周期的数目为6~36个,其整体宽度(8)为0.5~10mm,其筋宽度(4)为0.06~0.6mm。5. The medical stent with large radial support force according to claim 1, characterized in that when the stent is used for expansion and support of vascular stenosis, its outer diameter (11) is 1-20 mm, and its total length (13) is 5-150mm, the wall thickness (12) is 0.02-0.4mm, the number of sine wave cycles of the sinusoidal circular ring-shaped basic structure (1) is 6-36, and its overall width (8) is 0.5-10mm. The width (4) is 0.06-0.6mm. 6、根据权利要求1所述的大径向支撑力医用支架,其特征在于该支架用于人体内非血管腔道狭窄部位的扩张与支撑作用时,其外径(11)为6~25mm,总长(13)为50~140mm,壁厚(12)为0.1~0.5mm,正弦波形圆环状基本结构(1)的正弦波周期的数目为6~30个,其整体宽度[8]为1.0~10mm,其筋宽度(4)为0.15~0.7mm。6. The medical stent with large radial supporting force according to claim 1, characterized in that when the stent is used for expansion and support of non-vascular lumen stenosis in the human body, its outer diameter (11) is 6-25mm, The total length (13) is 50-140 mm, the wall thickness (12) is 0.1-0.5 mm, the number of sine wave cycles of the sinusoidal circular ring-shaped basic structure (1) is 6-30, and its overall width [8] is 1.0 ~10mm, the rib width (4) is 0.15~0.7mm. 7、根据权利要求1所述的大径向支撑力医用支架,其特征在于该支架端部做成喇叭口型。7. The medical stent with large radial supporting force according to claim 1, characterized in that the end of the stent is bell-shaped. 8、根据权利要求1所述的大径向支撑力医用支架,其特征在于该支架内外表面覆盖金属膜、氧化物膜、高分子膜或缓释药物膜。8. The medical stent with large radial supporting force according to claim 1, characterized in that the inner and outer surfaces of the stent are covered with metal film, oxide film, polymer film or slow-release drug film. 9、根据权利要求1所述的大径向支撑力医用支架,其特征在于刻蚀该支架的金属管的材质是不锈钢、或钛合金、或纯金属钽或金。9. The medical stent with large radial supporting force according to claim 1, wherein the material of the metal tube for etching the stent is stainless steel, or titanium alloy, or pure metal tantalum or gold.
CNB2005100376133A 2005-01-06 2005-01-06 Large-radical-support-force medical stent Expired - Fee Related CN100348281C (en)

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