CN102488571B - Magnetic-ring artificial sphincter and manufacture and application method thereof - Google Patents

Magnetic-ring artificial sphincter and manufacture and application method thereof Download PDF

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CN102488571B
CN102488571B CN 201110409735 CN201110409735A CN102488571B CN 102488571 B CN102488571 B CN 102488571B CN 201110409735 CN201110409735 CN 201110409735 CN 201110409735 A CN201110409735 A CN 201110409735A CN 102488571 B CN102488571 B CN 102488571B
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magnetic
material
ring
sphincter
support
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CN102488571A (en
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罗成华
赵红平
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音络(北京)科技发展有限公司
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Abstract

本发明涉及一种磁环人工括约肌,即一种基于磁性体的环状结构装置,以多个磁性体经连接材料相互串接而成,通过磁性体的磁力吸引作用及连接材料的可滑动与可伸缩特征进行可逆性扩展和内缩,埋置于体内空腔管道环周,可模拟正常人体括约肌功能,增强或重建因括约肌力量减弱或丧失的器官的括约肌功能,控制空腔脏器内容物的正常流向,可代替或重建食道、贲门、幽门、回盲部、肛管、膀胱、尿道周围及消化道与泌尿系造口处等处的括约肌组织。 The present invention relates to an artificial sphincter ring, means a ring structure, i.e., based on the magnetic body, the plurality of magnetic bodies to each other by the connecting material of the concatenation, the attraction by the magnetic force of the magnetic material and connected to the body and slidably characterized reversibly telescopically extended and retracted, the pipe is embedded in the cavity of the body circumference, the body can simulate normal sphincter, sphincter reconstruction or enhancement of organs due to sphincter strength weakened or lost, the contents of the control hollow organs normal flow, may replace or rebuild the esophagus, cardia, pylorus, ileocecal, anal, bladder, around the urethra and urinary and digestive tract stoma etc. sphincter tissue. 本发明操作简便,制造工序少,功能可靠,在生物医学领域有着广泛的应用前景。 The present invention is easy to operate, less manufacturing steps, functionally reliable, has a wide range of applications in the biomedical field.

Description

一种磁环人工括约肌及其制造和应用方法 One kind of ring artificial sphincter and manufacturing and application methods

技术领域 FIELD

[0001] 本发明涉及一种医疗器械,特别涉及一种磁环人工括约肌,即一种基于磁性体的环状结构装置。 [0001] The present invention relates to a medical instrument, particularly to an artificial sphincter ring, that is, a cyclic structure of the apparatus based on the magnetic body. 由磁性金属、生物相容性材料及支撑材料构成的磁性体,通过连接材料串联在一起,埋置于体内空腔脏器环周,可代替或重建食道、贲门、幽门、回盲部、肛管、尿道、肠道及泌尿系造口处等的括约肌结构,增强或重建括约肌力量减弱或丧失的器官的括约能力,控制消化道及泌尿道内容物的正常流向及排泄。 A magnetic metal, the magnetic material and a biocompatible support material in series by connecting together the material, embedded in the circumference of hollow organs in vivo, can replace or rebuild the esophagus, cardia, pylorus, ileocecal, anal tubes, urethral sphincter structures, intestinal and urinary tract stoma or the like, to enhance strength or sphincter reconstruction weakening or loss of ability to sphincter organ, and excretion controlling the flow of normal gastrointestinal tract and urinary tract contents.

背景技术 Background technique

[0002] 括约肌是分布于人体内某些空腔脏器环周的环形肌肉,对于控制空腔脏器内容物的正常流向具有至关重要的作用。 [0002] sphincter in the human body is distributed in some hollow organs circumferential annular muscle, for controlling the flow of the normal content of the hollow organ has a crucial role. 各种原因导致的功能减弱或丧失会引起临床上严重的不良后果,如食管下贲门括约肌功能减弱引起反流性食道炎及Brrett食管,幽门括约肌松弛致胆汁反流性胃炎,尿道括约肌损伤引起尿失禁,肛门括约肌损伤引起大便失禁。 All causes of weakened or loss can cause serious adverse clinical consequences, such as the lower esophageal sphincter weakened cause reflux esophagitis and Brrett esophageal, pyloric sphincter relaxation induced by bile reflux gastritis, urethral sphincter damage caused by the urine incontinence, anal sphincter damage caused by fecal incontinence. 如何对空腔脏器括约肌功能进行恢复和重建已成为临床医生面临的严峻挑战。 How to carry out rehabilitation and reconstruction of hollow organs sphincter function has become a serious challenge facing clinicians.

[0003] 以大便失禁为例。 [0003] with fecal incontinence, for example. 美国的一项大规模调查显示普通人群中高达7.1%的人有不同程度的大便失禁。 A large-scale survey showed US general population up to 7.1% of people have varying degrees of fecal incontinence. 大便失禁虽然不能致命,但却给患者带来巨大的生活不便和身心痛苦,甚至造成人格变化。 Fecal incontinence, although not fatal, but it has brought great inconvenience to patients and physical and mental suffering, and even cause personality changes. 为了恢复肛门正常功能,有效控制大便失禁,多年来国内外学者作了多方面的探索,特别是试图通过肌肉移植来重建肛门括约肌功能。 In order to restore the normal function of the anus, effective control of fecal incontinence, over the years made many domestic and foreign scholars to explore, especially in trying to reconstruct the anal sphincter muscle function through transplantation. 虽然在此基础上不断改进手术方式,但肛门功能的恢复并不理想。 While on the basis of the continuous improvement of surgical procedures, but the recovery is not ideal anal function. 1989年Christiansen首先应用人工肛门括约肌控制大便失禁,为大便失禁的治疗开辟了一条新的途径。 In 1989 Christiansen first application of artificial anal sphincter fecal incontinence control, has opened up a new way for the treatment of fecal incontinence. 近年来,随着生物材料的发展以及对排便生理的认识加深,人工肛门括约肌有了较新的发展,如水泵式人工肛门括约肌与形状记忆合金人工肛门括约肌等。 In recent years, with the development of biological materials and to deepen understanding of the physiology of defecation, artificial anal sphincter with newer developments, such as pumps and artificial anal sphincter SMA artificial anal sphincter.

[0004] 水泵式人工肛门括约肌是通过以水泵为动力的套囊在肛管直肠周围制造一个稳定的高压区域来获得控制排便的能力,也称为套囊式人工肛门括约肌。 [0004] The pump is manufactured artificial anal sphincter pump powered by the cuff around a stable high pressure anorectal area to obtain the ability to control defecation, also referred to as cuff artificial anal sphincter. 水泵式人工肛门括约肌的设计过于复杂,套囊和贮液囊容易腐蚀导致机械故障,因此不能长久应用。 Artificial anal sphincter pump design is too complex, the cuff and the reservoir bag easily lead to corrosion of mechanical failure, it is not long application. 而且套囊在体内没有固定,在周围的脂肪组织中仍有一定的活动空间,因此,套囊由于反复活动对周围组织特别是肛周浅表组织经常性的刺激势必产生炎性反应;加之套囊不均匀的高压作用,导致组织的腐蚀、感染、疼痛、伤口裂开等一系列并发症,从而限制了其在临床的广泛应用。 And not fixed to the cuff body, the adipose tissue surrounding still some space, therefore, the cuff surrounding tissues due to repeated activities particularly perianal recurrent superficial tissue inflammatory response stimulation bound; cuff is not coupled with a uniform high pressure, cause corrosion, infection, pain, wound dehiscence series of complications tissue, thereby limiting its widespread clinical application.

[0005] 形状记忆合金人工肛门括约肌主要是由两条双程形状记忆的钛-镍合金为主要材料,两端分别用铰链连接起来形成的一个椭圆环。 [0005] Shape memory alloy is mainly composed of an artificial anal sphincter titanium way shape memory of two pairs - a nickel alloy as the main material oval ends were hinged together to form a ring. 经过两次特殊处理之后,在体温时呈扁平的形状,而加热到52°C就变成弧状。 After two special treatment, has a flat shape at body temperature, heated to 52 ° C becomes an arc. 记忆合金在这两个温度间可以发生形状变化,在体温状态下扁平形状的记忆合金夹闭肠腔,加热之后记忆金属就变成椭圆形开放肠腔。 The shape memory alloy can vary between these two temperatures, a flat shape at body lumen occlusion state memory alloy, after heating the memory metal becomes elliptical open lumen. 但是,形状记忆合金人工肛门括约肌压迫肠组织部分会形成纤维包膜,而这个纤维包膜会引起闭合压力的改变从而导致顺应性下降及开闭失灵。 However, the shape memory alloy artificial anal sphincter intestinal tissue compression branch portion formed fibrous capsule, and this will cause the fibrous capsule closure pressure change resulting in decreased compliance and thereby open and close failure. 另一方面,局部组织加热至52°C左右在很多病人是无法承受:的。 On the other hand, localized tissue heating to about 52 ° C in many patients can not afford: a. 发明内容 SUMMARY

[0006] 本发明的目的在于:克服现有的人工括约肌的缺点,提供一种极为简便、制造工序少、材料简单、能耗小、投入资金少、适合实验室研究制备和医疗器械行业大规模生产的人工磁环括约肌。 Objective [0006] The present invention is: to overcome the disadvantages of the prior artificial sphincter, to provide an extremely simple and less manufacturing process, simple materials, low energy consumption, less investment, suitable for laboratory research and the preparation of large-scale medical device industry production of artificial sphincter ring.

[0007] 本发明的目的是这样实现的: [0007] The object of the present invention is implemented as follows:

[0008] 一、本发明公开了一种磁环人工括约肌的制作与应用方法,基于磁性体是否为组合式,分为两类,包括: [0008] First, the present invention discloses an artificial sphincter, a ring production and application methods, based on whether a combined magnetic material, divided into two categories, comprising:

[0009] 1、基于非组合式的磁性体的磁环人工括约肌的制作方法 [0009] 1, an artificial sphincter, based on the non-magnetic modular manufacturing method of the magnetic material

[0010] 步骤1,根据造口的大小,确定磁珠的数目; [0010] Step 1, according to the size of the stoma, to determine the number of beads;

[0011] 步骤2,将一定数目的磁珠通过有弹性的连接线串联,形成磁环人工括约肌; [0011] Step 2, a certain number of elastic beads via a connection line in series to form a ring artificial sphincter;

[0012] 步骤3,将磁环人工括约肌高压消毒,埋置于体内; [0012] Step 3, the artificial sphincter autoclaving ring, embedded in the body;

[0013] 步骤4,进行感染控制。 [0013] Step 4, to control infection.

[0014] 由步骤1、步骤2、步骤3与步骤4,从而可以得到一种简便有效的基于非组合式的磁性体的人工磁环括约肌。 [0014] From Step 1, Step 2, Step 3 and Step 4 can be obtained based on a simple and effective artificial sphincter ring of non-magnetic material combined.

[0015] 所述磁珠为有永久磁性的金属或非金属。 [0015] The magnetic beads have a permanent or non-magnetic metal. [0016] 所述磁珠的形状为球体、半球体、圆柱体、三角体、长方体、椭球体。 [0016] The shape of the beads is a sphere, a hemisphere, a cylinder, a triangular body, rectangular, ellipsoid.

[0017] 所述磁珠的主要长度从0.1微米到5厘米。 The [0017] main bead length from 0.1 microns to 5 centimeters.

[0018] 所述的磁珠外表面可根据临床实际,磁珠外表面涂抹生物相容性较好的材料,如硅橡胶、丝蛋白、胶原蛋白、壳聚糖、聚乙二醇等。 [0018] The outer surface of the beads according to clinical practice, the outer surface of the bead applicator is preferably biocompatible material, such as silicone rubber, silk protein, collagen, chitosan, polyethylene glycol, and the like.

[0019] 所述的磁珠外表面的颜色可以根据临床实际确定,如红色、棕色、桃红色、灰色、绿色、蓝色、白色与黑色等。 [0019] The color of the outer surface of the bead may be determined according to the actual clinical, such as red, brown, pink, gray, green, blue, white and black.

[0020] 所述每个磁环中磁珠的数目从2个到100个。 [0020] The number of beads in each ring from 2-100.

[0021] 所述的磁环的数目从I圈到10圈。 [0021] The number of magnetic ring from I to 10 turns.

[0022] 所述的弹性的连接线材料为棉、金属丝、蚕丝、橡胶等。 The elastic material connecting line [0022] of the cotton, metal wire, silk, rubber or the like.

[0023] 2、基于组合式的磁性体的磁环人工括约肌的制作方法 [0023] 2. The method of making artificial sphincter ring magnetic material based on the combined

[0024] 步骤1,制作一个磁性金属体或非金属体的模具,形成磁性体中磁性金属或磁性非金属的组件。 [0024] Step 1, a mold made of metal or non-metal magnetic body, a magnetic body forming a magnetic metal or magnetic non-metallic components.

[0025] 步骤2,制作一个支撑体模具,支撑体与磁性金属体或非金属体间紧密结合,支撑体预留连接材料穿入孔,形成一个磁性体结构。 [0025] Step 2 to produce a mold support, between the support and the metal or non-metal magnetic body closely, the support material penetrates reserved connection hole, forming a magnetic structure. 支撑体外表面被覆一定厚度的生物相容性材料,其表面与组织作防粘连处理。 Biocompatible material covering the outer surface of the support a certain thickness, a surface for tissue adhesion prevention process. 磁性体由磁性金属、生物相容性材料及支撑体组成,其中磁性金属安装在支撑体内;支撑体外表面为连接材料预留有小孔;支撑体外表面覆着一定厚度的生物相容性材料。 A magnetic metal magnetic body, and a support member composed of a biocompatible material, wherein the magnetic metal is mounted in the support body; outer surface of the support material is reserved for the connection apertures; a support covered with the outer surface of a biocompatible material of a certain thickness.

[0026] 步骤3,制作一个连接材料模具,形成连接组件。 [0026] Step 3, the mold making a connecting material, a connection assembly. 连接材料穿过支撑体小孔,其中连接材料端部直径大于支撑体小孔直径,确保连接材料不会从支撑体脱开;将一定数目的磁性体通过连接材料串联,形成磁环人工括约肌。 Connecting material passes through the support hole, wherein an end portion of larger diameter than the connecting material support pore diameter, to ensure that the connecting material does not disengage from the support; and a number series by connecting the magnetic material to form an artificial sphincter ring.

[0027] 步骤4,利用连接组件将多个磁性体通过所述连接材料串联在一起,形成至少一个磁环,所述磁环适于埋置于体内空腔脏器环周,以代替或重建括约肌结构。 [0027] Step 4, using the connection assembly is connected via said plurality of magnetic material together in series, forming at least one ring, said ring is embedded in the body is adapted to the circumference of hollow organs, in place of or rebuild sphincter structure.

[0028] 所述步骤I中,根据临床需要,磁性体为永久磁性的金属或非金属,可采用不同磁力强度材料,所形成的金属体或非金属体可呈立方体、圆形体、柱形体以及各种不规则体形状。 [0028] In the step I, according to clinical need, the magnetic body is a permanent or non-magnetic metal, a different strength of magnetic materials, metallic or non-metallic body is formed body may be cuboid, the circular body, the cylindrical body and various irregular shape.

[0029] 所述步骤2中,支撑体大小形状完全决定于磁性金属体或非金属体,两者之间的贴合可采用粘合、嵌合、咬合与无缝焊接等形式。 In [0029] step 2, the support depends on the size and shape entirely metallic or non-metallic magnetic material, can be bonded between the two bonding, fitting, welding or the like engaged with seamless form. 支撑体与连接材料间采用最小摩擦力设计。 The minimum frictional force between the support and the design of the connecting material employed.

[0030] 所述步骤2中,支撑体,其材料为金属材料,如钛与钛合金、不锈钢、铝与铝合金等,或无机物如羟基磷灰石等。 [0030] In the step 2, the support, which material is a metallic material, such as titanium and titanium alloys, stainless steel, aluminum and aluminum alloy, an inorganic substance such as hydroxyapatite, or the like.

[0031] 所述步骤2中,磁性体外覆着物为生物相容性材料,且与组织作防粘连处理,如硅橡胶、丝蛋白、胶原蛋白、壳聚糖、聚乙二醇。 In [0031] step 2, the magnetic coating was as in vitro biocompatible material, and for tissue adhesion prevention process, such as silicone rubber, silk protein, collagen, chitosan, polyethylene glycol. 表面的颜色可以根据临床实际,如红色、棕色、桃红色、灰色、绿色、蓝色、白色与黑色等。 The color of the surface may be clinical practice, such as red, brown, pink, gray, green, blue, white and black. 所述磁性体外壳的形状为球体、半球体、圆柱体、三角体、长方体、椭球体、弧形扁平体、六面体和/或八面体。 The shape of the magnetic body case of a sphere, a hemisphere, a cylinder, a triangular body, rectangular, ellipsoid, curved flat body, hexahedron and / or octahedral. 所述磁性体的主要长度从0.1微米到5厘米。 The main length of the magnetic material from 0.1 micrometers to 5 centimeters. [0032] 所述步骤3中,连接材料有弹性或无弹性,有记忆性或无记忆性,为金属或非金属材料,如棉、金属丝、蚕丝、橡胶等制成的线。 [0032] The 3, the connecting elastic or inelastic material, with memory or memoryless, metallic or non-metallic materials, such as cotton, metal wire, silk, rubber or the like made of wires step.

[0033] 所述步骤4中,每个磁环中磁性体的数目为2个至100个。 In [0033] step 4, the number of magnetic material in each ring is 2 to 100. 磁环的数目为I圈至10圈。 I is the number of magnetic ring 10 to ring.

[0034] 所述步骤4中,人工括约肌代替的体内括约肌所属的体内空腔脏器包括食道、贲门、幽门、回盲部、肛管、尿道以及肠造口、回肠或结肠代膀胱造口。 [0034] In step 4, an artificial sphincter, in place of the body hollow organ in the body belong includes esophagus sphincter, cardiac, pyloric, ileocecal, anal, and urinary tract stoma, the ileum or colon cystostomy.

[0035] 二、具有磁性的物体,它有以至于无形的力,既能把一些东西吸过来,又能把一些东西排开。 [0035] Second, the magnetic object, so that it invisible force, both the absorption over something, and something can discharge opening. 磁体吸引物体或排斥物体所施的力即是磁力。 Magnets attract or repel objects object applied force that is magnetic. 磁力既然是力,那么它就有大小,而磁力的大小与磁体本身有着密不可分的关系。 Since it is a magnetic force, it will have the size, and the size of the magnetic force of the magnet itself has a close relationship. 本发明由于采用了永磁性物体的磁性与磁力的关系,提供了一种磁环人工括约肌。 The present invention adopts a magnetic relationship with the permanent magnetic properties of the object, there is provided a magnetic artificial sphincter.

[0036] (I)本发明制作工艺简单、能耗少、资金投入少、可操作性强、临床易于实施; [0036] (I) of the present invention, the production process is simple, less energy consumption, less capital investment, easy to operate, easy to implement clinical;

[0037] (2)本发明适合面广,对食道、贲门、幽门、回盲部、肛管、尿道、消化道及泌尿道造口处等需要的括约肌功能,均可采用本发明所制备的磁环人工括约肌替代; [0037] (2) The present invention is suitable for a wide range of needs esophagus sphincter function, cardiac, pyloric, ileocecal, anal, urethral, ​​digestive and urinary tract stoma and the like, can be prepared using the present invention, the magnetic Alternatively artificial sphincter ring;

[0038] (3)本发明的磁环人工括约肌的直径具有可控制性,可通过磁性体的直径与个数来实现; [0038] (3) the diameter of the ring of the present invention with an artificial sphincter controllability can be achieved by the number and diameter of the magnetic body;

[0039] (4)本发明的磁环人工括约肌的磁力具有可控制性,可通过磁性体的材料、直径、数目以及磁环的数目来实现; [0039] (4) magnetic artificial sphincter of the present invention having a magnetic controllability, may be realized by the number of the magnetic material and the number of the diameter of the ring;

[0040] (5)本发明的磁环人工括约肌的宽度具有可控制性,可通过磁性体的直径、磁环的圈数来实现。 [0040] (5) ring artificial sphincter of the present invention has a width controllability, may be realized by a number of turns of the magnetic diameter of the ring.

附图说明 BRIEF DESCRIPTION

[0041] 图1是本发明磁环人工括约肌的示意图,其中I为磁性体,2为支撑体,3为连接线 [0041] FIG. 1 is a schematic diagram of the present invention is an artificial sphincter ring, where I is the magnetic body, the support body 2, 3 is a connection line

[0042] 图2是本发明磁环人工括约肌的示意图,其中图2(A)是本发明实施例1与本发明实施例2的磁环人工括约肌示意图 [0042] FIG. 2 is a schematic diagram of the present invention is an artificial sphincter ring, wherein FIG. 2 (A) is a schematic view of an artificial sphincter, magnetic Example 1 Example 2 of the present invention, the embodiment of the present invention

[0043] 图3是本发明实施例3的磁环人工括约肌示意图 [0043] FIG. 3 is a schematic diagram of an artificial sphincter, ring 3 of the embodiment of the present invention

[0044] 图4是本发明实施例4的磁环人工括约肌示意图 [0044] FIG. 4 is a schematic view of an artificial sphincter, the magnet ring of the embodiment of the present invention Example 4

[0045] 图5是本发明实施例5的磁环人工括约肌示意图具体实施方式 [0045] FIG. 5 is a schematic view of an artificial sphincter ring DETAILED DESCRIPTION Example embodiments of the present invention 5

[0046] 下面结合附图和实施例对本发明进行详细地说明。 Drawings and embodiments of the present invention will be described in detail [0046] below in conjunction.

[0047] 图1是本发明采用的磁环人工括约肌示意图。 [0047] FIG. 1 is a schematic view of an artificial sphincter, ring employed in the present invention. 图UA)显示的是八面体形状的非组合式磁珠;图1(B)显示的是圆柱形状的的非组合式磁珠;图1(C)显示的是球体形状的非组合式磁珠;图1 (D)显示的是组合式磁环人工括约肌,图中I为磁性体,2为支撑体,3为连接线。 FIG UA) shows a non-magnetic beads combined octahedral shape; FIG. 1 (B) shows a non-cylindrical shape of the combined magnetic beads; FIG. 1 (C) shows a non-spherical shape of the beads combined ; FIG. 1 (D) shows a modular artificial sphincter ring, FIG. I is the magnetic body, 2 is a support, 3 is a connection line.

[0048] 图2是本发明采用的磁环人工括约肌示意图,其中图2(A)的示意图显示的是组合式磁环人工括约肌,其规格为:组合式磁柱体球体,直径为6毫米。 [0048] FIG. 2 is a schematic view of an artificial sphincter, ring employed in the present invention, wherein FIG. 2 (A) is a schematic diagram showing the combined magnetic artificial sphincter, which specifications: modular body cylinders spheres, 6 mm in diameter. 类似的还有球体、半球体、圆柱体、三角体、长方体、椭球体、弧形扁平体等形状的磁性体,其主要长度从0.1微米到5厘米;其中图2(B)的示意图显示的是非组合式磁环人工括约肌,其规格为:非组合式磁珠体,直径为6毫米。 There are similar shape magnetic sphere, a hemisphere, a cylinder, a triangular body, rectangular, ellipsoid, curved flat body, its main length from 0.1 microns to 5 centimeters; Figure 2 (B) is a schematic diagram showing the a non-magnetic modular artificial sphincter, which specifications: non-modular beads with a diameter of 6 mm. 类似的还有球体、半球体、圆柱体、三角体、长方体、椭球体、弧形扁平体等形状的磁性体,其主要长度从0.1微米到5厘米; There are similar sphere, a hemisphere, a cylinder, a triangular body, rectangular, ellipsoid, curved shape like a flat magnetic body, and its main length from 0.1 microns to 5 centimeters;

[0049] 实施例1 [0049] Example 1

[0050] 采用如图2(A)所示的装置,制备磁环人工括约肌,I为由铁镍钴制成的铁磁性金属体,2为由钛合金制成的支撑体,4为由纯钛制成的可伸缩连接线。 [0050] The apparatus shown in FIG. 2 (A), prepared artificial sphincter ring, by the I ferromagnetic metal body made of iron-nickel-cobalt, the support body 2 by the titanium alloy, by pure 4 made of titanium retractable cable. 将20个具有永磁性且直径为6毫米组合式磁性体通过可滑动伸缩的钛线串联在一起,制备出磁环型磁环人工括约肌,随后根据食道管腔的大小,确定磁性体的数目,游离出需植入磁环人工括约肌的部位,植入恰当的消毒好的磁性体人工括约肌,连接两端成环状,最后进行感染控制。 The permanent magnet 20 having a diameter of 6 mm and a combined magnetic body by slidably retractable titanium wire strung together to prepare a magnetic ring type artificial sphincter, depending on the size of the esophagus lumen and then, determining the number of magnetic material, a free ring for an artificial sphincter implant site, the implant properly sterilized artificial sphincter good magnetic material, connected at both ends in a ring, the final infection control.

[0051] 实施例2 [0051] Example 2

[0052] 采用如图2(A)所示的装置,制备磁环人工括约肌,I为由铝镍钴制成的永磁性金属体,2为由不锈钢合金制成的表面被覆有生物相容性材料的支撑体,4为由纯铝制成的且表面被覆有生物相容性材料的可伸缩连接线。 [0052] The apparatus shown in FIG. 2 (A), prepared artificial sphincter ring, the I by the permanent metal body made of alnico, 2 by surface coating made of a stainless steel alloy biocompatible the support material 4 and the surface formed by aluminum coated with biocompatible material retractable cable. 将20个具有永磁性且直径为6毫米组合式磁性体通过可滑动伸缩的铝线串联在一起,制备出磁环型磁环人工括约肌,随后根据食道管腔的大小,确定磁性体的数目,游离出需植入磁环人工括约肌的部位,植入恰当的消毒好的磁性体人工括约肌,连接两端成环状,最后进行感染控制。 The permanent magnet 20 having a diameter of 6 mm and a magnetic material combined in series by a slidable telescopic aluminum together to prepare a magnetic ring type artificial sphincter, depending on the size of the esophagus lumen and then, determining the number of magnetic material, a free ring for an artificial sphincter implant site, the implant properly sterilized artificial sphincter good magnetic material, connected at both ends in a ring, the final infection control.

[0053] 实施例3 [0053] Example 3

[0054] 采用如图3所示的装置,制备磁环人工括约肌:将20个具有永磁性且直径为6毫米的非组合式球状磁性体通过橡胶线串联在一起,制备出磁珠型磁环人工括约肌,随后根据幽门管腔的大小,确定磁性体的数目,游离出需植入磁环人工括约肌的部位,植入恰当的消毒好的磁性体人工括约肌,连接两端成环状,最后进行感染控制。 [0054] The apparatus shown in FIG. 3, the artificial sphincter ring preparation: the wire together in series by a rubber 20 having a permanent magnet and a diameter of 6 mm spherical non-magnetic material combined, to prepare a magnetic bead type artificial sphincter, the pylorus and then according to the size of the lumen, determining the number of magnetic material, the free magnetic implant for an artificial sphincter portion, the implant properly sterilized artificial sphincter good magnetic material, connected at both ends in a ring, and finally infection control.

[0055] 实施例4 [0055] Example 4

[0056] 采用如图4所示的装置,制备磁环人工括约肌:将15个具有永磁性且长度为6毫米的非组合式磁柱通过棉线串联在一起,制备出磁柱型磁环人工括约肌,随后根据肛管管腔的大小,确定磁性体的数目,游离出需植入磁环人工括约肌的部位,植入恰当的消毒好的磁性体人工括约肌,连接两端成环状,最后进行感染控制。 [0056] using the apparatus shown in FIG. 4, the preparation of the artificial sphincter ring: the combination of cylinders 15 having a non-permanent magnet and a length of 6 mm by cotton connected in series, prepared cylinders ring type artificial sphincter , then depending on the size of the lumen of the anal canal, determining the number of magnetic material, the free magnetic implant for an artificial sphincter portion, the implant properly sterilized artificial sphincter good magnetic material, connected at both ends in a ring, and finally infection control.

[0057] 实施例5 [0058] 采用如图5所示的装置,制备磁环人工括约肌:将5个具有永磁性且直径为8毫米的非组合式磁珠与5个具有永磁性且长度为6毫米的非组合式磁柱通过金属线间隔串联在一起,制备出磁珠磁柱型磁环人工括约肌,随后根据尿道管腔的大小,确定磁性体的数目,游离出需植入磁环人工括约肌的部位,植入恰当的消毒好的磁性体人工括约肌,连接两端成环状,最后进行感染控制。 [0057] Example 5 [0058] The apparatus shown in FIG. 5, the preparation of an artificial sphincter ring: the permanent magnet 5 having a diameter of 8 mm and a combined non-magnetic beads having a permanent magnet 5 and a length of 6 mm non-modular cylinders spaced together in series by wires, cylinders type magnetic beads prepared artificial sphincter, then depending on the size of the urethral lumen, determining the number of magnetic material, the free magnetic implant for an artificial sphincter site, the implant properly sterilized artificial sphincter good magnetic material, connected at both ends in a ring, the final infection control.

Claims (1)

1.一种磁环人工括约肌,包括多个磁性体及连接材料,其特征在于: (1)磁性体由磁性金属、生物相容性材料及支撑体组成,其中磁性金属安装在支撑体内;支撑体外表面为连接材料预留有小孔;支撑体外表面覆着一定厚度的生物相容性材料; (2)连接材料穿过支撑体小孔,其中连接材料端部直径大于支撑体小孔直径,确保连接材料不会从支撑体脱开,将一定数目的磁性体通过连接材料串联,形成磁环人工括约肌; 其中,所述磁性金属与支撑体之间采用无缝焊接形式进行贴合;所述支撑体与连接材料间采用最小摩擦力设计;所述支撑体的材料选自不锈钢;所述生物相容性材料表面与组织做防粘连处理; 所述磁性体的形状为弧形扁平体;所述磁性体外表面的颜色为黑色;所述生物相容性材料选自硅橡胶;每个磁环中磁性体的数目为20个,所述磁性体为直 An artificial sphincter ring, and a connector comprising a plurality of magnetic material, wherein: (1) a magnetic metal magnetic body, and a support member composed of a biocompatible material, wherein the magnetic metal is mounted in the support body; a support the outer surface material is reserved for the connection apertures; a support covered with the outer surface of a thickness of biocompatible material; (2) connected to the support material through the apertures, wherein the material of the end portion of larger diameter than the connector support pore diameter, ensure that the connection does not disengage from the support material, a certain number of magnetic material by the connection in series, forming an artificial sphincter ring; wherein, for bonding orbital welded between the magnetic metal in the form of the support member; the the minimum frictional force between the support and the design of the connecting material employed; the support material is selected from stainless steel; tissue surfaces the biocompatible material to make a sticking prevention processing; shape of the magnetic body is an arcuate flat member; the said outer surface of the magnetic color is black; the biocompatible material is selected from silicone rubber; each ring in the number of magnetic material 20, the magnetic body is straight 为6毫米组合式磁性体通过可滑动伸缩的铝线串联在一起;以及所述磁环的数目为10圈。 6 mm by a combined magnetic body slidably retractable aluminum series together; and the number of the ring 10 turns.
CN 201110409735 2011-12-12 2011-12-12 Magnetic-ring artificial sphincter and manufacture and application method thereof CN102488571B (en)

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CN103637860B (en) * 2013-12-23 2015-06-24 上海交通大学 Open-close control system for artificial anal sphincter prosthesis

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