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CN107280806B - Urethra urine controller - Google Patents

Urethra urine controller Download PDF

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Publication number
CN107280806B
CN107280806B CN201710523087.4A CN201710523087A CN107280806B CN 107280806 B CN107280806 B CN 107280806B CN 201710523087 A CN201710523087 A CN 201710523087A CN 107280806 B CN107280806 B CN 107280806B
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valve
urethral
connecting ring
magnet
leaflet
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CN107280806A (en
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孙颖浩
肖亮
严新谊
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Second Military Medical University SMMU
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/0004Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0009Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed in or outside the body opening close to the surface of the body
    • A61F2/0018Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed in or outside the body opening close to the surface of the body magnetic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol

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  • Health & Medical Sciences (AREA)
  • Urology & Nephrology (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)
  • Prostheses (AREA)

Abstract

The invention discloses a urethra urine controller, which comprises: a urethral stent, wherein the urethral stent is a reticular tube; a connector comprising a connector ring; a urethral valve connected with the connecting ring and forming a valve capable of controlling the opening and closing of a longitudinal channel of the urethral stent, wherein the urethral valve comprises at least one valve leaf, and at least one valve leaf can swing and open; the inner part of the edge of the swingable valve blade and the inner part of the connecting piece and/or the adjacent valve blade which are movably connected with the swingable valve blade are embedded with the magnet combination which attracts each other. In the invention, the urethral stent is of a net structure, and is in line contact with the urethra after being implanted, so that the stimulation to the urethra and the incidence rate of corresponding complications are reduced, and the comfort of the urethra after being implanted is improved. The swing of the valve leaflet can be controlled by controlling the magnet combination, so that the opening and closing of the urethral valve are controlled, the controllability of urination is realized, and the valve port is large when the valve leaflet is opened, so that the urination is smooth.

Description

一种尿道控尿器A urethral urinary control device

技术领域technical field

本发明属于医疗器械技术领域,具体涉及一种尿道控尿器。The invention belongs to the technical field of medical devices, and in particular relates to a urethral urinary control device.

背景技术Background technique

尿失禁是由于尿道括约肌损伤或神经功能障碍而丧失排尿自控能力,使尿液不自主地流出。尿失禁是人类泌尿系统较为常见的疾病。其病因有多种,常由先天或后天性的脑、脊髓病变、创伤、前列腺手术、尿道狭窄修补术等引起。它不仅对患者的生活造成不便和痛苦,而且有可能导致严重的并发症,甚至危及患者生命。安置人工尿道括约肌是目前可根本解决尿失禁问题的主要方法之一,但国际上已在临床应用的人工尿道括约肌均需要手术植入。一方面,有的患者病情没有严重到需要手术的程度或由于其它原因不希望做手术;另一方面,植入人工尿道括约肌可能引起尿道坏死等严重后遗症。Urinary incontinence is the loss of self-control of urination due to urethral sphincter damage or nerve dysfunction, making urine flow out involuntarily. Urinary incontinence is a relatively common disease of the human urinary system. There are many causes, often caused by congenital or acquired brain and spinal cord lesions, trauma, prostate surgery, urethral stricture repair, etc. It not only causes inconvenience and pain to the patient's life, but also may cause serious complications and even endanger the patient's life. Placement of artificial urinary sphincter is currently one of the main methods that can fundamentally solve the problem of urinary incontinence, but the artificial urinary sphincter that has been clinically used in the world requires surgical implantation. On the one hand, some patients are not seriously ill enough to require surgery or do not want surgery due to other reasons; on the other hand, artificial urinary sphincter implantation may cause serious sequelae such as urethral necrosis.

通过比较容易的处置解除尿失禁的痛苦更容易被患者接受。作为消极手段,有穿戴尿布、配置尿液袋等手段,但是需要频繁的更换,使用以及更换时的不适与气味对患者的心理造成负面影响。作为积极的手段,应当寻求一种通过自主控制排尿来抑制尿失禁的方法。Relieving the pain of urinary incontinence through easier treatment is more acceptable to patients. As negative means, there are means such as wearing diapers and configuring urine bags, but frequent replacement is required, and the discomfort and smell during use and replacement have a negative impact on the patient's psychology. As a positive approach, a method of suppressing urinary incontinence through voluntary control of voiding should be sought.

美国专利4909785与美国专利5112306公开的尿道阀门是由易变的液囊和一套排水装置组成的常闭阀门,当压迫液囊时,阀门打开,经过一段时间延搁后,阀门自动关闭,以便将膀胱排空。但是该装置结构复杂,体积大,而且可能在液囊非正常受压时,发生误操作而漏尿。U.S. Patent 4,909,785 and U.S. Patent 5,112,306 disclose a urethral valve that is a normally closed valve that is made up of a variable liquid bag and a set of drainage device. Bladder emptying. However, the device has a complex structure and a large volume, and may cause misoperation and urine leakage when the fluid bag is abnormally pressed.

欧洲专利WO9822039A1与中国专利CN102405033A公开的控尿装置则属于磁动式,通过体外磁场对体内磁铁的作用控制阀门开闭。不同的是前者公开的控尿装置植入于阴茎远端,且末端在阴茎外实现定位及固定,其结构简单、体积小,但增加了感染的风险。后者公开的控尿装置通过记忆合金固定于膀胱内腔,其结构复杂、体积大。而且上述两种装置多由金属构件组成,其暴露于尿液中,易产生污垢或杂菌而引起卫生问题。另外它们的控制阀为球形阀体,球形阀体大,阀门开放的小,导致尿流小排尿不畅。The urinary control device disclosed in European Patent WO9822039A1 and Chinese Patent CN102405033A belongs to the magnetic type, and the opening and closing of the valve is controlled by the action of the external magnetic field on the internal magnet. The difference is that the urinary control device disclosed by the former is implanted at the distal end of the penis, and the end is positioned and fixed outside the penis. It has a simple structure and small size, but increases the risk of infection. The urinary control device disclosed by the latter is fixed in the inner cavity of the bladder by a memory alloy, and has a complex structure and a large volume. And above-mentioned two kinds of devices mostly are made up of metal components, and it is exposed in the urine, easily produces dirt or miscellaneous bacteria and causes hygienic problem. Their control valve is a spherical valve body in addition, and the spherical valve body is big, and the opening of the valve is small, resulting in small urine flow and poor urination.

发明内容Contents of the invention

因此,针对现有技术中控尿装置不能同时满足结构简单、操作方便、排尿顺畅、可靠性高且无感染风险等要求的技术问题,本发明的目的在于提供一种可同时满足上述要求的尿道控尿器。Therefore, in view of the technical problems that the urinary control device in the prior art cannot simultaneously meet the requirements of simple structure, convenient operation, smooth urination, high reliability, and no risk of infection, the purpose of the present invention is to provide a urethra that can simultaneously meet the above requirements. Containment device.

本发明的尿道控尿器包括:The urethral continence device of the present invention comprises:

尿道支架,所述尿道支架为可植入尿道的网状管;A urethral stent, the urethral stent is a mesh tube that can be implanted into the urethra;

连接件,所述连接件包括连接环,所述连接环横向固设于所述尿道支架中段管壁上;以及A connecting piece, the connecting piece includes a connecting ring, and the connecting ring is laterally fixed on the wall of the middle section of the urethral stent; and

尿道瓣膜,所述尿道瓣膜与所述连接环连接并组成可控制所述尿道支架的纵向通道开闭的阀门,所述尿道瓣膜包括至少一片优选1~6片瓣叶,且其中至少有一片瓣叶可摆动打开;The urethral valve, the urethral valve is connected with the connecting ring to form a valve that can control the opening and closing of the longitudinal channel of the urethral stent, the urethral valve includes at least one leaflet, preferably 1 to 6 leaflets, and at least one leaflet The leaves can swing open;

可摆动的瓣叶的一至两个点或一条边与所述连接件固定连接,可摆动的瓣叶未固定连接的边与所述连接件和/或相邻的瓣叶活动相接,可摆动的瓣叶的边缘内部和与之活动相接的所述连接件和/或相邻的瓣叶内部嵌设有相互吸引的磁铁组合;One to two points or one edge of the swingable leaflet is fixedly connected with the connecting piece, and the unfixed side of the swingable leaflet is in movable contact with the connecting piece and/or the adjacent leaflet, and can swing The inside of the edge of the valve leaflet and the connecting piece and/or the interior of the adjacent leaflet are embedded with a combination of magnets that attract each other;

所述的活动相接是指:所述磁铁组合吸合时可摆动的瓣叶与所述连接件和/或相邻瓣叶无缝连接,所述磁铁组合在外界磁场作用下分开时可摆动的瓣叶与所述连接件和/或相邻瓣叶分开。The movable connection refers to: the swingable leaflets are seamlessly connected with the connecting piece and/or adjacent leaflets when the magnet combination is attracted, and the magnet combination can swing when separated under the action of an external magnetic field The leaflets are separated from the connector and/or adjacent leaflets.

其中,所述尿道支架设置成网状结构,植入于尿道时,与尿道接触为线接触,减小接触面积和对尿道的刺激,提高了植入后尿道的舒适性。Wherein, the urethral stent is arranged in a mesh structure, and when implanted in the urethra, the contact with the urethra is a line contact, which reduces the contact area and the stimulation to the urethra, and improves the comfort of the urethra after implantation.

所述连接环起到连接密封的作用,可固设于所述尿道支架的内侧、外侧或内外侧之间。所述连接环的外侧轮廓可以是与所述尿道支架匹配的圆形,内侧轮廓可以是圆形、多边形或者是其他便于与所述瓣叶密封连接的形状,优选圆形。The connecting ring acts as a connecting seal and can be fixed on the inner side, the outer side or between the inner side and the outer side of the urethral support. The outer contour of the connecting ring can be a circle that matches the urethral stent, and the inner contour can be a circle, a polygon or other shapes that facilitate sealing connection with the valve leaflet, preferably a circle.

所述磁铁组合可选用磁铁与磁铁的组合,也可选用磁铁与未磁化的铁磁性金属的组合,或者其他可行的组合形式。The combination of magnets may be a combination of magnets or magnets, or a combination of magnets and unmagnetized ferromagnetic metals, or other feasible combinations.

由上述可知,当所述尿道瓣膜只有一片瓣叶时,其即为可摆动的瓣叶。当所述尿道瓣膜有多片瓣叶时,其中部分或全部的瓣叶可以摆动,因此所述尿道瓣膜的开关可以是全部瓣叶都参与运动,也可以是部分瓣叶固定不动部分运动,优选所有的瓣叶都可以摆动,以此瓣叶打开时,可加大所述尿道瓣膜的开口,使得排尿更加顺畅。各瓣叶的形状和大小可以相同,也可不同,比如半圆、小于半圆的和大于半圆的扇形。瓣叶可以是对称形状也可以是非对称形状。It can be known from the above that when the urethral valve has only one leaflet, it is a swingable leaflet. When the urethral valve has multiple leaflets, some or all of the leaflets can swing, so the switch of the urethral valve can be that all the leaflets participate in the movement, or some leaflets are fixed and some move. Preferably, all leaflets can swing, so that when the leaflets are opened, the opening of the urethral valve can be enlarged to make urination more smooth. The shape and size of each leaflet can be the same or different, such as a semicircle, a sector smaller than a semicircle, and a sector larger than a semicircle. Leaflets can be symmetrical or asymmetrical in shape.

本发明中,可摆动的瓣叶是通过所述磁铁组合的相吸作用与所述连接件或相邻瓣叶无缝连接,使得所述尿道瓣膜处于常闭状态。当向所述磁铁组合施加较强的外界磁场时,所述磁铁组合可分开,进而所述瓣叶摆动,所述尿道瓣膜打开进行排尿,以此实现自主地开闭所述尿道瓣膜,以达到自主排尿的目的。In the present invention, the swingable leaflets are seamlessly connected with the connecting member or the adjacent leaflets through the attraction effect of the magnet combination, so that the urethral valve is in a normally closed state. When a strong external magnetic field is applied to the magnet combination, the magnet combination can be separated, and then the leaflets swing, and the urethral valve opens for urination, so as to realize the autonomous opening and closing of the urethral valve, so as to achieve The purpose of voluntary urination.

本发明的一些较佳实施例中,所述尿道瓣膜只有1片瓣叶,所述瓣叶边缘相对的两个点与所述连接环固定连接;所述磁铁组合成对地分别嵌设在所述瓣叶边缘内部和所述连接环内部,所述瓣叶边缘通过所述磁铁组合的吸合作用活动连接在所述连接环的下面。In some preferred embodiments of the present invention, the urethral valve has only one leaflet, and two points opposite to the edge of the leaflet are fixedly connected to the connecting ring; The edge of the leaflet is connected to the inside of the connecting ring, and the edge of the leaflet is movably connected to the lower side of the connecting ring through the attraction of the magnet assembly.

本发明另一些较佳实施例中,所述尿道瓣膜包括2~6片优选3~4片扇形的瓣叶,各所述瓣叶组成圆形且均可摆动,各所述瓣叶的弧形边与所述连接环固定连接,所述磁铁组合成对地分别嵌设在相邻的所述瓣叶的侧边内部,相邻的所述瓣叶的侧边为相互匹配的斜面、弧面、倾斜弧面或阶梯面并通过所述磁铁组合的吸合作用无缝连接。In other preferred embodiments of the present invention, the urethral valve includes 2 to 6, preferably 3 to 4 fan-shaped leaflets, each of which is circular and can swing, and the arc shape of each leaflet is The side is fixedly connected with the connecting ring, and the magnets are combined in pairs and respectively embedded in the side edges of the adjacent leaflets, and the side edges of the adjacent leaflets are inclined surfaces and arc surfaces that match each other. , inclined arc surface or stepped surface and are seamlessly connected through the suction effect of the magnet combination.

本发明的另一些较佳实施例中,所述连接件还包括连接骨架,所述连接骨架连接在所述连接环中,所述连接骨架呈直线或散射状将所述连接环分隔成2~6个优选3~4个扇形区。In some other preferred embodiments of the present invention, the connecting piece further includes a connecting skeleton, the connecting skeleton is connected in the connecting ring, and the connecting skeleton separates the connecting ring into 2~ 6, preferably 3 to 4 sectors.

进一步的,当所述尿道瓣膜只有1片瓣叶时,所述瓣叶中心与所述连接骨架中心固定连接,所述磁铁组合嵌设在所述瓣叶边缘内部和所述连接环内部,所述瓣叶边缘通过所述磁铁组合活动连接在所述连接环的下面。Further, when the urethral valve has only one leaflet, the center of the leaflet is fixedly connected to the center of the connecting frame, and the magnet assembly is embedded inside the edge of the leaflet and inside the connecting ring, so The edge of the leaflet is movably connected to the lower side of the connecting ring through the combination of magnets.

或者进一步的,当所述尿道瓣膜包括与所述扇形区对应的2~6片优选3~4片扇形的瓣叶时,各所述瓣叶的弧形边与所述连接环固定连接,所述磁铁组合成对地分别嵌设在所述瓣叶的侧边内部和所述连接骨架内部,所述瓣叶的侧边与所述连接骨架具有相互匹配的斜面、弧面、倾斜弧面或阶梯面并通过所述磁铁组合的吸合作用无缝连接。Or further, when the urethral valve includes 2 to 6, preferably 3 to 4 fan-shaped leaflets corresponding to the fan-shaped area, the arc-shaped side of each leaflet is fixedly connected to the connecting ring, so The magnets are combined in pairs and respectively embedded inside the side of the leaflet and the inside of the connecting frame, and the side of the leaflet and the connecting frame have mutually matching slopes, arcs, inclined arcs or The stepped surfaces are seamlessly connected through the suction effect of the magnet combination.

又或者进一步的,当所述尿道瓣膜包括与所述扇形区对应的2~6片优选3~4片扇形的瓣叶时,各所述瓣叶顶角固定连接于所述连接骨架的中心,所述磁铁组合成对地分别嵌设在各所述瓣叶的弧形边内部和所述连接环内部以及各所述瓣叶的侧边内部和所述连接骨架内部;各所述瓣叶的弧形边和所述连接环以及各所述瓣叶的侧边与所述连接骨架具有相互匹配的斜面、弧面、倾斜弧面或阶梯面,并分别通过所述磁铁组合的吸合作用无缝连接。Or further, when the urethral valve includes 2 to 6, preferably 3 to 4, fan-shaped leaflets corresponding to the fan-shaped area, the top corners of each leaflet are fixedly connected to the center of the connecting frame, The magnets are combined in pairs and respectively embedded in the inside of the arc edge of each of the leaflets and the inside of the connecting ring, as well as the inside of the side of each of the leaflets and the inside of the connecting frame; The arc edge, the connecting ring, and the side edges of each leaflet and the connecting frame have mutually matching inclined surfaces, arc surfaces, inclined arc surfaces or stepped surfaces, and are ineffective through the attraction effect of the magnet combination respectively. seam connection.

所述尿道支架材质可选自镍钛记忆合金、钛合金、镁合金、钴铬钼合金、不锈钢、有机玻璃(PMMA)、聚氯乙烯(PVC)、聚乙烯(PC)或超高分子量聚乙烯(UHMWPE)。所述的连接件材质也可选自镍钛记忆合金、钛合金、镁合金、钴铬钼合金、不锈钢、有机玻璃、聚氯乙烯、聚乙烯、超高分子量聚乙烯。所述尿道瓣膜材质采用生物相容性的柔性材料。The material of the urethral stent can be selected from nickel-titanium memory alloy, titanium alloy, magnesium alloy, cobalt-chromium-molybdenum alloy, stainless steel, plexiglass (PMMA), polyvinyl chloride (PVC), polyethylene (PC) or ultra-high molecular weight polyethylene (UHMWPE). The material of the connecting piece can also be selected from nickel-titanium memory alloy, titanium alloy, magnesium alloy, cobalt-chromium-molybdenum alloy, stainless steel, plexiglass, polyvinyl chloride, polyethylene, and ultra-high molecular weight polyethylene. The material of the urethral valve is biocompatible flexible material.

所述连接件与所述尿道支架为可以是一体结构,也可以是拼接结构。The connecting piece and the urethral stent may be of an integrated structure or may be of a spliced structure.

优选的,所述尿道支架由镍钛记忆合金编织而成。进一步的,所述尿道支架和所述连接环低温时柔软,可挤压缩变成条索状,植入方便;恢复记忆合金相变温度后,在原位恢复形状,定位准确。Preferably, the urethral stent is braided from nickel-titanium memory alloy. Further, the urethral stent and the connecting ring are soft at low temperature and can be squeezed into a cord shape, which is convenient for implantation; after restoring the phase transition temperature of the memory alloy, the shape is restored in situ and the positioning is accurate.

优选的,所述尿道支架的内壁、外壁或内外壁之间添加有一层覆膜,所述覆膜是可以在人体中植入的医用柔性材料膜。覆膜里面可添加抗炎或止血类药物,缩减术后患者的康复时间,抑制并发症的发生,提高患者生活质量。Preferably, a covering film is added on the inner wall, the outer wall or between the inner and outer walls of the urethral stent, and the covering film is a medical flexible material film that can be implanted in the human body. Anti-inflammatory or hemostatic drugs can be added to the film to shorten the recovery time of postoperative patients, inhibit the occurrence of complications, and improve the quality of life of patients.

优选的,所述医用柔性材料膜为医用硅胶膜、医用聚氨脂膜或医用聚四氟乙烯膜。Preferably, the medical flexible material film is a medical silicone film, a medical polyurethane film or a medical polytetrafluoroethylene film.

本发明的另一目的在于提供一种尿道控尿器组件,其包括所述的尿道控尿器和与所述磁铁组合配合使用的磁性吸引装置。所述磁性吸引装置用于提供体外较强的磁场,可使用磁铁或电磁线圈。较佳的,所述磁性吸引装置系缚或集成于裤腰带或松紧带上,排尿时,将裤腰带或松紧带拉下来即可控制尿道排尿器打开。Another object of the present invention is to provide a urethral continence assembly, which includes the urethral continence and a magnetic attraction device used in conjunction with the magnet. The magnetic attraction device is used to provide a strong magnetic field outside the body, and a magnet or an electromagnetic coil can be used. Preferably, the magnetic attraction device is tied or integrated on the trouser waistband or the elastic band, and when urinating, the trouser waistband or the elastic band is pulled down to control the opening of the urethral urinator.

本发明的有益效果:Beneficial effects of the present invention:

1、本发明采用尿道支架与尿道瓣膜配合的形式,结构简单,成本低廉,体积小。其中,所述尿道支架为网状结构,植入于尿道与尿道接触为线接触,接触面积小,可有效减小对尿道的刺激以及相应并发症的发生率,提高植入后尿道的舒适性。1. The present invention adopts the cooperation form of urethral stent and urethral valve, which has simple structure, low cost and small volume. Wherein, the urethral stent has a mesh structure, and the contact area between the urethra and the urethra is small, which can effectively reduce the irritation to the urethra and the incidence of corresponding complications, and improve the comfort of the urethra after implantation. .

2、本发明通过磁铁组合的相吸作用使可摆动的瓣叶与相邻瓣叶和/或连接件相接,使尿道瓣膜处于常闭状态,可达到较高的密封性,进而可提高尿道控尿器的可靠性。而通过控制较强的外界磁场的施加,使得磁铁组合分开并带着可摆动的瓣叶摆动,进而控制所述尿道瓣膜的打开,尿道通畅即可排尿,实现自主排尿的目的,而且由于尿道支架厚度薄,瓣叶打开时的阀口大,尿流大,排尿更加顺畅。2. The present invention connects the swingable leaflets with the adjacent leaflets and/or connectors through the mutual attraction of the magnet combination, so that the urethral valve is in a normally closed state, which can achieve higher sealing performance and further improve the urethral valve. Urinary Continence Reliability. And by controlling the application of a strong external magnetic field, the magnet combination is separated and swings with the swingable leaflets, and then the opening of the urethral valve is controlled. The thickness is thin, the valve opening is large when the leaflets are opened, the urine flow is large, and the urination is smoother.

3、所述尿道支架可由镍钛记忆合金编织而成,低温时柔软,可挤压缩变成条索状,植入方便;恢复记忆合金相变温度后,在原位恢复形状,定位准确。3. The urethral stent can be braided by nickel-titanium memory alloy, which is soft at low temperature and can be squeezed into a cord shape, which is convenient for implantation; after restoring the phase transition temperature of the memory alloy, the shape can be restored in situ and the positioning is accurate.

4、所述尿道瓣膜采用生物相容性的柔性材料,并与尿道支架通过上述连接环密封件直接连接,可减少由于污垢或杂菌引起的卫生问题。4. The urethral valve is made of biocompatible flexible material, and is directly connected with the urethral stent through the above-mentioned connecting ring seal, which can reduce hygiene problems caused by dirt or miscellaneous bacteria.

附图说明Description of drawings

图1是本发明实施例1的尿道控尿器的立体示意图;Fig. 1 is a three-dimensional schematic diagram of a urethral urinary control device according to Embodiment 1 of the present invention;

图2是本发明实施例1中瓣叶与连接环结构示意图;Fig. 2 is a schematic diagram of the structure of the leaflet and the connecting ring in Embodiment 1 of the present invention;

图3是本发明实施例1中相邻瓣叶连接处剖视图;Fig. 3 is a cross-sectional view of the junction of adjacent valve leaflets in Embodiment 1 of the present invention;

图4、5是本发明实施例1的不同片数的瓣叶与连接环结构示意图;4 and 5 are structural schematic diagrams of valve leaflets and connecting rings with different numbers of pieces in Embodiment 1 of the present invention;

图6~9是本发明其他类型的相邻瓣叶连接处剖视图;6 to 9 are cross-sectional views of other types of junctions between adjacent leaflets of the present invention;

图10是本发明实施例2的尿道控尿器的立体示意图;Fig. 10 is a three-dimensional schematic diagram of a urethral urinary control device according to Embodiment 2 of the present invention;

图11是本发明实施例2中瓣叶与连接环结构示意图;Fig. 11 is a schematic diagram of the structure of the leaflet and the connecting ring in Embodiment 2 of the present invention;

图12是本发明实施例2的尿道控尿器在阀口打开状态的立体示意图;Fig. 12 is a three-dimensional schematic diagram of the urethral urinary control device in the second embodiment of the present invention when the valve port is open;

图13是本发明实施例3的尿道控尿器的立体示意图;Fig. 13 is a three-dimensional schematic diagram of a urethral urinary control device according to Embodiment 3 of the present invention;

图14~16是本发明实施例3中瓣叶与连接环结构示意图;14-16 are schematic diagrams of the structure of the valve leaflet and the connecting ring in Embodiment 3 of the present invention;

图17~21是本发明实施例3不同类型的相邻瓣叶和连接骨架连接处剖视图;17-21 are cross-sectional views of different types of adjacent valve leaflets and connecting skeletons in Embodiment 3 of the present invention;

图22是本发明实施例4的尿道控尿器的立体示意图;Fig. 22 is a three-dimensional schematic diagram of a urethral urinary control device according to Embodiment 4 of the present invention;

图23、24是本发明实施例4中瓣叶与连接环结构示意图;23 and 24 are schematic diagrams of the structure of the valve leaflet and the connecting ring in Embodiment 4 of the present invention;

图25~27是本发明的实施例1的尿道控尿器的覆膜添设位置示意图。25 to 27 are schematic diagrams of the film-adding positions of the urethral continence device according to Embodiment 1 of the present invention.

附图标记:Reference signs:

1-尿道支架,2-连接环,3-尿道瓣膜,4-磁铁组合,5-连接骨架,6-覆膜。1-urethral stent, 2-connecting ring, 3-urethral valve, 4-magnet assembly, 5-connecting skeleton, 6-covering.

具体实施方式Detailed ways

以下结合具体实施例和附图,对本发明作进一步说明。应理解,以下实施例仅用于说明本发明而非用于限定本发明的范围。The present invention will be further described below in conjunction with specific embodiments and accompanying drawings. It should be understood that the following examples are only used to illustrate the present invention but not to limit the scope of the present invention.

实施例1Example 1

图1所示为本发明一较佳实施例的尿道控尿器,其包括尿道支架1、连接环2和尿道瓣膜3。FIG. 1 shows a urethral continence device in a preferred embodiment of the present invention, which includes a urethral support 1 , a connecting ring 2 and a urethral valve 3 .

尿道支架1为可植入尿道的网状管,其由镍钛记忆合金编织而成,低温时柔软,可挤压缩变成条索状,植入尿道方便,恢复记忆合金相变温度后,在原位恢复形状,定位准确。Urethral stent 1 is a mesh tube that can be implanted into the urethra. It is braided by nickel-titanium memory alloy. It is soft at low temperature and can be squeezed into a rope shape. The shape is restored in situ, and the positioning is accurate.

连接环2横向固定于尿道支架1中段管壁上,与尿道支架1为一体结构。The connecting ring 2 is laterally fixed on the tube wall of the middle section of the urethral stent 1 and is integrated with the urethral stent 1 .

尿道瓣膜3由三片均可摆动的扇形瓣叶31、32和33构成,扇形瓣叶31、32和33的弧形边与连接环2无缝固定连接,如图2所示,扇形瓣叶31、32和33相互连接的侧边(直线边)如图3所示,为相互匹配的倾斜弧面,且内部分别嵌设有相互吸引的磁铁组合4(包括成对的41a和43b、42a和41b以及43a和42b),通过磁铁组合4的相互吸引瓣叶的相邻直线边无缝对接形成闭合。The urethral valve 3 is composed of three fan-shaped leaflets 31, 32 and 33 that can swing, and the arc edges of the fan-shaped leaflets 31, 32 and 33 are seamlessly fixedly connected with the connecting ring 2, as shown in Figure 2, the fan-shaped leaflets 31, 32 and 33 mutually connected side (straight edge) as shown in Figure 3, is the inclined arc surface that matches each other, and the magnet combination 4 (comprising paired 41a and 43b, 42a that attracts each other is respectively embedded with inside) and 41b and 43a and 42b), through the seamless butt joint of the adjacent linear sides of the mutually attracting leaflets of the magnet assembly 4 to form a closure.

其中,磁铁组合4为磁铁与磁铁的组合,可以通过N、S极相互吸引,比如41a和43b的N、S极分别位于两端且相互倒置,以此可以相互吸引,而42a和41b以及43a和42b也是相同的设置。当然也可以是磁铁与未磁化的铁磁性金属的组合或者其他可能的组合,比如41a、42a和43a为磁铁,而41b、42b和43b为未磁化的铁磁性金属。在较强的外磁场的作用下,磁铁组合4在纵向的磁力作用下可以分离,瓣叶31、32和33随之打开,因此通过体外更强磁场的可自主实现尿道瓣膜3的开闭,以达到自主排尿的目的。Among them, the magnet combination 4 is a combination of magnets and magnets, which can attract each other through the N and S poles. For example, the N and S poles of 41a and 43b are respectively located at both ends and inverted to each other, so that they can attract each other, while 42a and 41b and 43a And 42b is also the same setting. Of course, it can also be a combination of magnets and unmagnetized ferromagnetic metals or other possible combinations, such as 41a, 42a and 43a are magnets, and 41b, 42b and 43b are unmagnetized ferromagnetic metals. Under the action of a strong external magnetic field, the magnet assembly 4 can be separated under the action of the longitudinal magnetic force, and the valve leaflets 31, 32 and 33 are opened accordingly. Therefore, the opening and closing of the urethral valve 3 can be realized autonomously through a stronger magnetic field outside the body. In order to achieve the purpose of voluntary urination.

尿道瓣膜3的瓣叶数量还可适当的增加或减少。比如尿道瓣膜3可由两片对开的半圆形瓣叶组成,如图4所示,磁铁组合4嵌设在两片半圆形瓣叶相接的侧边内部。半圆形瓣叶的弧顶与连接环2固定连接。再比如,如图5所示,尿道瓣膜3由四片相同的直角扇形瓣叶组成,磁铁组合4嵌设在相邻的直角扇形瓣叶相接的侧边内部。直角扇形瓣叶的弧形边与连接环2固定连接,固定连接位置可以是弧顶也可以是整个弧形边,直角扇形瓣叶摆动时以弧顶或弧形边为固定支点。The number of leaflets of the urethral valve 3 can also be appropriately increased or decreased. For example, the urethral valve 3 can be composed of two semicircular leaflets split apart. As shown in FIG. 4 , the magnet assembly 4 is embedded inside the side where the two semicircular leaflets connect. The arc top of the semicircular leaflet is fixedly connected with the connecting ring 2 . For another example, as shown in FIG. 5 , the urethral valve 3 is composed of four identical right-angle fan-shaped leaflets, and the magnet assembly 4 is embedded in the inner sides where adjacent right-angle fan-shaped leaflets connect. The arc edge of the right-angle fan-shaped leaflet is fixedly connected with the connecting ring 2, and the fixed connection position can be the arc top or the entire arc edge.

另外,上述各种情形中,相邻瓣叶的相互连接的侧边还可以是相互匹配的直面(见图6)、斜面、弧面(见图7)、阶梯面(见图8)或阶梯弧面(见图9),只要能满足无缝相接即可。In addition, in the above-mentioned various situations, the interconnected sides of adjacent valve leaflets can also be straight surfaces (see Figure 6), inclined surfaces, arc surfaces (see Figure 7), stepped surfaces (see Figure 8) or stepped surfaces that match each other. The curved surface (see Figure 9) only needs to be seamlessly connected.

实施例2Example 2

图10所示为本发明另一较佳实施例的尿道控尿器,其与实施例1的不同在于尿道瓣膜3由一片圆形瓣叶34构成,如图11所示,圆形瓣叶34周缘两个相对的点34a与连接环2固定连接,圆形瓣叶34除去固定连接的两点34a的周缘其余部分与连接环2通过嵌设有的磁铁组合4活动相接,没有外磁场时,通过磁铁组合4的相互吸引圆形瓣叶34的周缘与连接环2无缝连接形成闭合。在外磁场作用下,圆形瓣叶34两边向下摆打开,如图12所示。Figure 10 shows another preferred embodiment of the urethral urinary control device of the present invention, which is different from Embodiment 1 in that the urethral valve 3 is made of a circular leaflet 34, as shown in Figure 11, the circular leaflet 34 Two opposite points 34a on the periphery are fixedly connected to the connecting ring 2, and the rest of the periphery of the circular leaflet 34 except the two fixedly connected points 34a is in movably contact with the connecting ring 2 through the embedded magnet assembly 4, when there is no external magnetic field , through the mutual attraction of the magnet assembly 4, the periphery of the circular leaflet 34 is seamlessly connected with the connecting ring 2 to form a closure. Under the action of an external magnetic field, both sides of the circular leaflet 34 swing downwards, as shown in FIG. 12 .

实施例3Example 3

图13所示为本发明另一较佳实施例的尿道控尿器,相比于实施例1,连接环2中还连接有连接骨架5,连接环2和连接骨架5组成连接件,连接骨架5呈散射状将连接环2分隔成3的扇形区,如图14所示。尿道瓣膜3由三片对应设于扇形区的可摆动的扇形瓣叶构成,各扇形瓣叶的弧形边与连接环2无缝固定连接,各扇形瓣叶的侧边与连接骨架5相接,可相互吸引的磁铁组合4同样嵌设在相邻扇形瓣叶的侧边内部。Fig. 13 shows another preferred embodiment of the urethral continence device of the present invention. Compared with Embodiment 1, the connecting frame 5 is also connected to the connecting ring 2, the connecting ring 2 and the connecting frame 5 form a connecting piece, and the connecting frame 5 divides the connecting ring 2 into sector-shaped areas of 3 in a scattering shape, as shown in FIG. 14 . The urethral valve 3 is composed of three swingable fan-shaped leaflets corresponding to the fan-shaped area. The arc-shaped edges of each fan-shaped leaflet are seamlessly and fixedly connected with the connecting ring 2, and the side edges of each fan-shaped leaflet are connected with the connecting frame 5. The magnet assembly 4 that can attract each other is also embedded inside the side edges of the adjacent fan-shaped leaflets.

其中,尿道瓣膜3的瓣叶也可调整为2片、4片或更多,对应的连接骨架5的形状作相应的调整,还可改为直线将连接环分隔为两个半圆区,也可增加骨架将连接环分隔为4个或多个扇形区,如图15所示。Wherein, the leaflets of the urethral valve 3 can also be adjusted to 2 pieces, 4 pieces or more, and the shape of the corresponding connecting frame 5 can be adjusted accordingly. Add a skeleton to divide the connection ring into 4 or more fan-shaped areas, as shown in Figure 15.

另外,磁铁组合还可成对地嵌设在瓣叶侧边和连接骨架内部,如图16所示。In addition, the magnet assembly can also be embedded in pairs on the side of the valve leaflet and inside the connecting frame, as shown in FIG. 16 .

各扇形瓣叶的侧边与连接骨架5的侧边为相匹配的倾斜弧面(见图17)、直面(见图18)、斜面、弧面(见图19)、阶梯面(见图20和21)或阶梯弧面,在磁铁组合4的吸合作用下,各扇形瓣叶与连接骨架无缝相接。The sides of each fan-shaped leaflet and the side of the connecting frame 5 are matching inclined arc surfaces (see Figure 17), straight surfaces (see Figure 18), inclined surfaces, arc surfaces (see Figure 19), and stepped surfaces (see Figure 20). and 21) or the stepped arc surface, under the attraction of the magnet combination 4, each fan-shaped leaflet is seamlessly connected with the connecting skeleton.

实施例4Example 4

图22所示为本发明另一较佳实施例的尿道控尿器,相比于实施例3,不同在于,尿道瓣膜3为1片,尿道瓣膜3中心固定在连接骨架5中心,磁铁组合4嵌设于尿道瓣膜3周缘内部和连接环2内部,如图23所示。在较强的外磁场的作用下,磁铁组合4在纵向的磁力作用下可以分离,尿道瓣膜3随之打开。Figure 22 shows another preferred embodiment of the urethral urinary control device of the present invention. Compared with Embodiment 3, the difference is that the urethral valve 3 is one piece, the center of the urethral valve 3 is fixed at the center of the connecting frame 5, and the magnet assembly 4 Embedded inside the periphery of the urethral valve 3 and inside the connecting ring 2, as shown in FIG. 23 . Under the action of a strong external magnetic field, the magnet assembly 4 can be separated under the action of longitudinal magnetic force, and the urethral valve 3 is opened accordingly.

在实施例4的基础上,尿道瓣膜3还可分为与扇形区对应的多片扇形瓣叶,如图24所示,各扇形瓣叶的顶角与连接骨架5中心固定连接,各扇形瓣叶的弧形边与连接环2通过磁铁组合活动相接,各扇形瓣叶的侧边与连接骨架5活动相接,当然,各扇形瓣叶的侧边和连接骨架内也可嵌设磁铁组合提高相接发紧密度。On the basis of Embodiment 4, the urethral valve 3 can also be divided into multiple fan-shaped leaflets corresponding to the fan-shaped area. The arc edge of the leaf is connected with the connection ring 2 through the combination of magnets, and the side of each fan-shaped leaflet is connected with the connection frame 5. Of course, the side of each fan-shaped leaflet and the connection frame can also be embedded with magnets. Improves the tightness of hair extensions.

较佳的,上述各实施例中,尿道支架1的内壁、外壁或内外壁之间可添加有一层覆膜6,如图25~27所示为实施例1的尿道控尿器添加有覆膜的三种情形。覆膜6是可以在人体中植入的医用柔性材料膜,优选为医用硅胶膜、医用聚氨脂膜或医用聚四氟乙烯膜。同时,覆膜里面可添加抗炎或止血类药物,缩减术后患者的康复时间,抑制并发症的发生,提高患者生活质量。Preferably, in each of the above-mentioned embodiments, a film 6 may be added to the inner wall, outer wall or between the inner and outer walls of the urethral stent 1, as shown in Figures 25-27, the urethral continence device in Embodiment 1 is provided with a film of the three situations. The covering film 6 is a medical flexible material film that can be implanted in the human body, preferably a medical silicone film, a medical polyurethane film or a medical polytetrafluoroethylene film. At the same time, anti-inflammatory or hemostatic drugs can be added to the film to shorten the recovery time of postoperative patients, inhibit the occurrence of complications, and improve the quality of life of patients.

另外,连接环2起到连接密封的作用,可固设于尿道支架1的内侧、外侧或内外侧之间。连接环2的外侧轮廓可以是与尿道支架1匹配的圆形,内侧轮廓可以是圆形、多边形或者是其他便于与瓣叶密封连接的形状优选圆形。瓣叶与连接环2相接的边缘可贴合在连接环2的下面,也可与连接环2内侧对接,所以瓣叶的边缘形状根据连接环2内侧轮廓作相应的调整,可以弧形也可是直线。In addition, the connecting ring 2 plays the role of connecting and sealing, and can be fixed on the inside, outside or between the inside and outside of the urethral stent 1 . The outer contour of the connecting ring 2 can be a circle matching the urethral stent 1 , and the inner contour can be a circle, a polygon or other shapes that facilitate sealing connection with the leaflets, preferably a circle. The edge of the leaflet connected to the connecting ring 2 can fit under the connecting ring 2, or it can be docked with the inner side of the connecting ring 2, so the edge shape of the leaflet can be adjusted accordingly according to the inner contour of the connecting ring 2, and can be curved or curved. But a straight line.

上述各实施例的尿道控尿器可结合磁吸引装置使用,磁性吸引装置用于提供体外较强的磁场,可使用磁铁或电磁线圈,较佳的,磁吸引装置可系缚或集成于裤腰带或松紧带上,排尿时,将裤腰带或松紧带拉下来即可控制尿道排尿器打开。The urethral continence device of each of the above embodiments can be used in combination with a magnetic attraction device, which is used to provide a strong magnetic field outside the body, and can use a magnet or an electromagnetic coil. Preferably, the magnetic attraction device can be tied or integrated into a trouser belt or When urinating, pull down the waistband or the elastic band to control the opening of the urethral urinator.

以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。The above-mentioned embodiments only express several implementation modes of the present invention, and the descriptions thereof are relatively specific and detailed, but should not be construed as limiting the patent scope of the invention. It should be noted that, for those skilled in the art, several modifications and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent for the present invention should be based on the appended claims.

Claims (10)

1. A urinary tract urine controller, comprising:
a urethral stent, which is a reticular tube implantable in the urethra;
the connecting piece comprises a connecting ring which is transversely and fixedly arranged on the middle tube wall of the urethral stent; and
a urethral valve connected with the connecting ring and forming a valve capable of controlling the opening and closing of a longitudinal channel of the urethral stent, wherein the urethral valve comprises at least one valve leaf, and at least one valve leaf can swing and open;
one or two points or one edge of the swingable valve leaf is fixedly connected with the connecting piece, the edge of the swingable valve leaf which is not fixedly connected with the connecting piece and/or the adjacent valve leaf is movably connected with the connecting piece, and a magnet combination which is mutually attracted is embedded in the edge of the swingable valve leaf and the connecting piece and/or the adjacent valve leaf which are movably connected with the edge of the swingable valve leaf;
the movable connection means: the valve leaf which can swing when the magnet combination is attracted is connected with the connecting piece and/or the adjacent valve She Mofeng, and the valve leaf which can swing when the magnet combination is separated under the action of an external magnetic field is connected with the connecting piece and/or the adjacent valve She Fenkai;
the magnet combination is a magnet and a magnet or a magnet and an unmagnetized ferromagnetic metal;
a layer of tectorial membrane is added between the inner wall, the outer wall or the inner wall and the outer wall of the urethral stent, the tectorial membrane is a medical flexible material membrane which can be implanted in a human body, and the medical flexible material membrane is a medical silica gel membrane, a medical polyurethane membrane or a medical polytetrafluoroethylene membrane.
2. A urinary tract urine control device according to claim 1 wherein the urinary tract valve has only 1 leaflet, the two points of the leaflet edge opposite each other being fixedly connected to the connecting ring; the magnet assemblies are embedded in the edge of the valve leaf and the inside of the connecting ring in pairs respectively, and the edge of the valve leaf is movably connected below the connecting ring through the attraction of the magnet assemblies.
3. The urinary tract urine control device according to claim 1, wherein the urinary tract valve comprises 2-6 fan-shaped valve leaves, each valve leaf is circular and can swing, the arc-shaped edge of each valve leaf is fixedly connected with the connecting ring, the magnet assemblies are respectively embedded in the side edges of the adjacent valve leaves in pairs, and the side edges of the adjacent valve leaves are mutually matched inclined planes, cambered surfaces, inclined cambered surfaces or stepped surfaces and are connected in a seamless manner through the suction effect of the magnet assemblies.
4. A urinary tract urine control device according to claim 1 wherein the connector further comprises a connecting skeleton connected in the connecting ring, the connecting skeleton dividing the connecting ring into 2-6 sectors in a straight line or in a scattering pattern.
5. The urinary tract urine control device according to claim 4 wherein the urinary tract valve has only 1 leaflet, the leaflet center is fixedly connected to the connecting frame center, the magnet assembly is embedded inside the leaflet edge and inside the connecting ring, and the leaflet edge is movably connected under the connecting ring by the magnet assembly.
6. The urinary tract urine control device according to claim 4 wherein the urinary tract valve comprises 2-6 fan-shaped valve leaflets corresponding to the fan-shaped areas, the arcuate edges of each valve leaflet are fixedly connected with the connecting ring, the magnet assemblies are respectively embedded in pairs in the side edges of the valve leaflets and the connecting framework, and the side edges of the valve leaflets and the connecting framework are provided with mutually matched inclined surfaces, cambered surfaces, inclined cambered surfaces or stepped surfaces and are seamlessly connected through the attraction of the magnet assemblies.
7. The urinary tract urine control device according to claim 4 wherein the urinary tract valve comprises 2-6 fan-shaped leaflets corresponding to the fan-shaped areas, each of the leaflet top corners being fixedly connected to the center of the connecting frame, the magnet assemblies being embedded in pairs within the arcuate edge of each of the leaflets and within the connecting ring and within the side edges of each of the leaflets and within the connecting frame, respectively; the arc-shaped edge of each valve leaf, the connecting ring, the side edge of each valve leaf and the connecting framework are provided with inclined planes, cambered surfaces, inclined cambered surfaces or stepped surfaces which are matched with each other, and are connected in a seamless mode through the attraction effect of the magnet combination.
8. The urinary tract urine control device according to claim 1, wherein the urinary tract stent is made of nickel-titanium memory alloy, titanium alloy, magnesium alloy, cobalt-chromium-molybdenum alloy, stainless steel, organic glass, polyvinyl chloride, polyethylene or ultra-high molecular weight polyethylene; the connecting ring is made of nickel-titanium memory alloy, titanium alloy, magnesium alloy, cobalt-chromium-molybdenum alloy, stainless steel, organic glass, polyvinyl chloride, polyethylene and ultra-high molecular weight polyethylene; the urethral valve is made of biocompatible flexible materials.
9. A urinary catheter as in claim 1, wherein said connector is of unitary construction with said urinary stent.
10. A urinary tract urine control device assembly comprising a urinary tract urine control device according to any one of claims 1 to 8 and a magnetic attraction device for use in combination with the magnet.
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