CN107596539B - Balloon dilatation catheter - Google Patents
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Abstract
本发明公开了一种扩张球囊导管,扩张球囊包括穿设于导管内部的导丝,导管一端固定连接有操作部,在远离操作部的导管的远端外侧中有一球囊,导管腔体和球囊内腔由设置在导管上的连通结构相连通,导丝包括相互分离的第一导丝和第二导丝,第一导丝的后端连接于操作部后端的插拔结构,第二导丝通过固定工艺固定于导管内部。本发明的导丝腔和注液腔可共用同一个导管腔体,大大减小了本发明的导管直径,从而使得本发明的扩张球囊导管可通过内窥镜的器械通道插入人体内需要扩张的狭窄管体或者腔体,实现可视化操作,具有很好的实用价值。
The invention discloses an expansion balloon catheter. The expansion balloon comprises a guide wire penetrated inside the catheter, one end of the catheter is fixedly connected with an operation part, and a balloon is located outside the distal end of the catheter away from the operation part. The body and the inner cavity of the balloon are connected by a communication structure arranged on the catheter, the guide wire includes a first guide wire and a second guide wire separated from each other, and the rear end of the first guide wire is connected to the plug-in structure at the rear end of the operation part, The second guide wire is fixed inside the catheter through a fixing process. The guide wire cavity and the liquid injection cavity of the present invention can share the same catheter cavity, which greatly reduces the diameter of the catheter of the present invention, so that the dilatation balloon catheter of the present invention can be inserted into the human body through the instrument channel of the endoscope. The dilated narrow tube body or cavity can realize visual operation, which has good practical value.
Description
技术领域technical field
本发明涉及医疗器械领域,尤其是涉及一种扩张球囊导管。The invention relates to the field of medical devices, in particular to an expansion balloon catheter.
背景技术Background technique
现有技术的扩张球囊导管,例如申请号为CN201520474689.1的实用新型涉及一种用于碎石术的封堵器,所述封堵器包括单向阀门开关、导管、手柄、封堵球囊、保护膜、金属导引导丝、小孔;所述的封堵球囊包裹在导管外表面,与导管形成一个封闭的囊腔,囊腔直径5-25mm;所述封堵球囊呈椭圆形或球形,长度为0.5-5cm;所述封堵球囊包裹的导管上设有小孔;所述导管远端端部固定连接有金属导引导丝;所述金属导引导丝被保护膜所包裹;所述导管近端固定连接手柄;所述手柄上设有条纹;所述单向阀门开关连接在导管近端端部;所述的单向阀门开关设有阀片;所述的单向阀门开关连接注射器或充气阀。该实用新型的用于碎石术的封堵器,所述封堵球囊包裹的导管上设有小孔,封堵球囊和导管内腔通过该小孔相互连通,液体可注入导管内腔继而进入封堵球囊来对球囊进行扩充,然而,该实用新型的封堵球囊在注水膨胀纵向伸长时,导管也变纵向拉伸形变,由于两者材质不一样,导管的形变会使得注水的球囊弯曲变形,这样会导致球囊肿胀时表面的撑开力不均匀,增加手术难度,降低手术治疗效果,且容易造成器械损伤。Existing art dilation balloon catheters, such as the utility model with application number CN201520474689.1, relates to an occluder for lithotripsy, the occluder includes a one-way valve switch, a catheter, a handle, a occlusion ball Balloon, protective film, metal guide wire, small hole; the blocking balloon is wrapped on the outer surface of the catheter, forming a closed cavity with the catheter, the diameter of the cavity is 5-25mm; the blocking balloon is oval shape or spherical shape, the length is 0.5-5cm; the catheter wrapped with the blocking balloon is provided with a small hole; the distal end of the catheter is fixedly connected with a metal guide wire; the metal guide wire is protected by a protective film The proximal end of the catheter is fixedly connected to the handle; the handle is provided with stripes; the one-way valve switch is connected to the proximal end of the catheter; the one-way valve switch is provided with a valve plate; the one-way valve switch is provided with a valve plate; The valve switch connects to the syringe or inflation valve. In the occluder of the utility model for lithotripsy, the catheter wrapped with the blocking balloon is provided with a small hole, the blocking balloon and the inner cavity of the catheter are communicated with each other through the small hole, and the liquid can be injected into the inner cavity of the catheter Then enter the occlusion balloon to expand the balloon. However, when the occlusion balloon of the utility model expands and expands longitudinally by water injection, the catheter also becomes longitudinally stretched and deformed. Due to the different materials of the two, the deformation of the catheter will The water-filled balloon is bent and deformed, which will cause uneven spreading force on the surface of the balloon when it is swollen, increase the difficulty of surgery, reduce the effect of surgical treatment, and easily cause device damage.
申请号为CN201510809012.3的发明提供了一种输尿管结石移动封堵装置,它由导管(1)、可扩张压缩气囊(2)和阀门(3)构成,导管(1)为具有弹性的中空长管状结构,由具有弹性的硅胶或乳胶材料制成,导管(1)的前端设置有开口,该开口位于可扩张压缩气囊(2)的气囊内;可扩张压缩气囊(2)设置在导管(1)的前端,其扩张状态为椭球体状;阀门(3)位于导管(1)的末端,其上设置有注射器接入口(4)。该装置的导管(1)的前段能够通过操作腔进入输尿管使气囊(2)相对固定于结石的上游输尿管腔内或者肾盂出口处,实现了阻断注水水流对肾脏的充盈扩张破坏作用,同时完全阻断了任何结石可能移位或者逃逸到肾盂的通路。该发明的导管(1)的前端设置有开口,该开口位于可扩张压缩气囊(2)的气囊内;可扩张压缩气囊(2)设置在导管(1)的前端,这样的折这使得引导导丝无法设置于压缩气囊前端,从而无法通过引导导丝起到安全引导和标志作用,从而容易引起输尿管损伤,降低手术成功率。The invention with application number CN201510809012.3 provides a device for moving and blocking ureteral calculi, which is composed of a catheter (1), an expandable and compressed balloon (2) and a valve (3), and the catheter (1) is an elastic hollow long The tubular structure is made of elastic silicone or latex material, the front end of the catheter (1) is provided with an opening, the opening is located in the balloon of the expandable and compressed airbag (2); the expandable and compressed airbag (2) is arranged on the catheter (1) ), the expansion state is ellipsoid; the valve (3) is located at the end of the catheter (1), and a syringe inlet (4) is arranged on it. The front section of the catheter (1) of the device can enter the ureter through the operating cavity, so that the balloon (2) is relatively fixed in the upstream ureteral cavity of the calculus or at the outlet of the renal pelvis, so as to block the filling, expanding and destroying effect of the injected water flow on the kidney, and at the same time completely The pathway through which any stones might migrate or escape into the renal pelvis is blocked. The front end of the catheter (1) of the invention is provided with an opening, and the opening is located in the balloon of the expandable and compressed balloon (2); The wire cannot be set at the front end of the compression balloon, so that the guide wire cannot play a role of safety guidance and marking, which may easily cause ureteral injury and reduce the success rate of the operation.
申请号为CN201120001866.6的实用新型公开了一种带有气囊的输尿管导管,包括:管体和气囊,其中:气囊位于管体外侧;管体的两端通透,且其壁上被气囊中的区域内设置有通孔;管体内设置有挡流板,挡流板将管体内的空间分成两个相互独立的腔,分别为注水腔和导丝腔,其中注水腔与通孔相连通,且一端设有开口,另一端封闭,导丝腔两端通透。该实用新型通过挡流板将管体内的空间分成两个相互独立的腔,分别为注水腔和导丝腔,由于挡流板是平行于输尿管导管的轴向而设,两个独立的腔各自需要的管径空间会增加导管的直径,从而使得导管的直径加粗,不利于导管自器械通道伸入人体,也会进一步增加患者的痛苦。The utility model with the application number CN201120001866.6 discloses a ureteral catheter with a balloon, comprising: a tube body and a balloon, wherein: the balloon is located outside the tube body; A through hole is arranged in the area of the tube; a baffle plate is arranged in the tube body, and the baffle plate divides the space in the tube body into two independent cavities, namely a water injection cavity and a guide wire cavity, wherein the water injection cavity is communicated with the through hole, One end is provided with an opening, the other end is closed, and both ends of the guide wire cavity are transparent. The utility model divides the space in the tube into two independent cavities through the baffle, which are the water injection cavity and the guide wire cavity respectively. Since the baffle is arranged parallel to the axial direction of the ureteral catheter, the two independent cavities are The required diameter space will increase the diameter of the catheter, thereby making the diameter of the catheter thicker, which is not conducive to the catheter extending into the human body from the instrument channel, and further increases the pain of the patient.
上述现有技术的扩张球囊导管受直径所限无法插入内窥镜的器械管道,也容易引起患者在治疗过程中的不适,提高了手术操作的难度,并且在气囊在注水膨胀纵向伸长时,容易弯曲变形,从而降低手术治疗效果,容易造成器械损伤。The above-mentioned expansion balloon catheter of the prior art cannot be inserted into the instrument pipeline of the endoscope due to the limitation of the diameter, and it is also easy to cause discomfort to the patient during the treatment process, which increases the difficulty of the operation. , it is easy to bend and deform, thereby reducing the effect of surgical treatment and easily causing equipment damage.
发明内容SUMMARY OF THE INVENTION
本发明公开一种扩张球囊导管,包括导管和穿设于导管内部的导丝,导管一端固定连接有操作部,在远离操作部的导管的远端外侧包覆有球囊,导管腔体和球囊内腔由设置在导管上的连通结构相连通,导丝包括在球囊内腔内相互分离的第一导丝和第二导丝,第一导丝的后端连接于操作部的插拔结构,第二导丝通过固定工艺固定于导管的另一端。The invention discloses an expanding balloon catheter, comprising a catheter and a guide wire penetrated inside the catheter, one end of the catheter is fixedly connected with an operation part, the outer side of the distal end of the catheter away from the operation part is covered with a balloon, and the catheter cavity is It is communicated with the inner cavity of the balloon by a communication structure arranged on the catheter, the guide wire includes a first guide wire and a second guide wire separated from each other in the inner cavity of the balloon, and the rear end of the first guide wire is connected to the operation part. In the plug-in structure, the second guide wire is fixed to the other end of the catheter through a fixing process.
优选地,导管在球囊中的管体区域相互分离为第一管体和第二管体,第一管体的后端固定连接于操作部,第二管体的外壁固定连接于球囊,第一管体和第二管体之间的断面相对构成一连通通道,连通通道作为连通结构将导管腔体和球囊内腔相连通,第二导丝插入第一管体内的插入深度大于在球囊4膨胀时第一管体和第二管体之间的分离距离。Preferably, the tube body region of the catheter in the balloon is separated from each other into a first tube body and a second tube body, the rear end of the first tube body is fixedly connected to the operating portion, and the outer wall of the second tube body is fixedly connected to the balloon, The cross-section between the first tube body and the second tube body relatively forms a communication channel, the communication channel is used as a communication structure to connect the catheter cavity and the balloon cavity, and the insertion depth of the second guide wire into the first tube body is greater than The separation distance between the first tubular body and the second tubular body when the
进一步地,球囊中的导管的管壁上设有一个或多个通孔,通孔作为连通结构连通导管腔体和球囊内腔,通孔14设置在第二导丝插入第一管体内的端部和第一管体与球囊的连接处之间。Further, the tube wall of the catheter in the balloon is provided with one or more through holes, the through holes are used as a communication structure to communicate the catheter cavity and the balloon lumen, and the through
优选地,球囊前端与第二管体的相连接之处设有显影环,显影环中区域的导管的内部封闭。Preferably, a developing ring is provided at the connection between the front end of the balloon and the second tube body, and the interior of the catheter in the region of the developing ring is closed.
优选地,导管远离操作部的一侧设置尖端导管,第二导丝延伸至尖端导管内,第二导丝位于尖端导管中的端部与尖端导管顶端的距离为0.5mm-2mm。Preferably, a tip catheter is provided on the side of the catheter away from the operation part, the second guide wire extends into the tip catheter, and the distance between the end of the second guide wire in the tip catheter and the tip of the tip catheter is 0.5mm-2mm.
优选地,导管远离操作部的一侧设置尖端导管,第二导丝远离操作部延伸至尖端导管的外部,第二导丝的位于尖端导管外部的部分设置为球状体结构。Preferably, a tip catheter is provided on the side of the catheter away from the operation part, the second guide wire extends away from the operation part to the outside of the tip catheter, and the part of the second guide wire located outside the tip catheter is configured as a spherical body structure.
优选地,操作部包括手持部,导管穿设于手持部内部,形成连通于球囊内腔的液体通道。Preferably, the operating portion includes a hand-held portion, and the catheter is penetrated inside the hand-held portion to form a liquid channel communicating with the inner cavity of the balloon.
进一步地,手持部的后端设有二通旋塞,二通旋塞的塞子上设置有旋塞通孔,当旋塞通孔与导管的管口同轴时,打开液体通道;当旋塞通孔与导管的管口垂直时,关闭液体通道。Further, the rear end of the hand-held part is provided with a two-way cock, the plug of the two-way cock is provided with a cock through hole, when the cock through hole is coaxial with the nozzle of the conduit, the liquid channel is opened; When the nozzle is vertical, close the liquid channel.
优选地,在球囊后端的导管外周面上设有刻度线。Preferably, a scale line is provided on the outer peripheral surface of the catheter at the rear end of the balloon.
进一步地,操作部的后端设有外螺纹,外螺纹可套接螺丝帽,螺丝帽作为插拔结构与第一导丝的后端相连接,可通过拆卸螺丝帽来拔出第一导丝。Further, the rear end of the operating part is provided with an external thread, the external thread can be sleeved with a screw cap, the screw cap is connected with the rear end of the first guide wire as a plug-in structure, and the first guide wire can be pulled out by removing the screw cap. .
综上所述,本发明的扩张球囊导管,包括相互分离的第一导丝和第二导丝,第一导丝可通过导管后端的开口进行插拔,从而使得导丝腔和注液腔可共用同一个导管腔体,无需另外设置注液腔,或者无需在导丝表面另外设置保护膜对导丝进行保护,如此大大减小了本实施例的扩张球囊导管的直径,从而使得本发明的扩张球囊导管可通过内窥镜的器械通道插入人体内需要扩张的狭窄管体或者腔体,实现可视化操作,具有很好的实用价值。To sum up, the dilatation balloon catheter of the present invention includes a first guide wire and a second guide wire that are separated from each other. The same catheter cavity can be shared, and there is no need to set up an additional injection cavity, or there is no need to set an additional protective film on the surface of the guide wire to protect the guide wire, which greatly reduces the diameter of the dilation balloon catheter of this embodiment, so that the The expansion balloon catheter of the present invention can be inserted into a narrow tube body or a cavity that needs to be expanded in the human body through the instrument channel of the endoscope, so as to realize visual operation, and has good practical value.
可用于泌尿系统(输尿管),消化系统(胆管,胰管)呼吸系统(气道)人体腔道狭窄的扩张。It can be used to dilate the narrowing of the human lumen of the urinary system (ureter), digestive system (bile duct, pancreatic duct), respiratory system (airway).
为让本发明的上述内容能更明显易懂,下文特举优选实施例,并结合附图,作详细说明如下。In order to make the above-mentioned content of the present invention more obvious and easy to understand, preferred embodiments are hereinafter described in detail with reference to the accompanying drawings.
附图说明Description of drawings
下面将结合附图介绍本发明。The present invention will be described below with reference to the accompanying drawings.
图1为本发明实施例中的扩张球囊导管的局部结构示意图;FIG. 1 is a schematic diagram of a partial structure of an expansion balloon catheter in an embodiment of the present invention;
图2为本发明实施例中的扩张球囊导管的另一局部结构示意图;Fig. 2 is another partial structural schematic diagram of the dilation balloon catheter in the embodiment of the present invention;
图3为本发明实施例中的扩张球囊导管的整体结构示意图。FIG. 3 is a schematic diagram of the overall structure of the dilation balloon catheter in the embodiment of the present invention.
具体实施方式Detailed ways
以下由特定的具体实施例说明本发明的实施方式,本领域技术人员可由本说明书所揭示的内容轻易地了解本发明的其他优点及功效。The embodiments of the present invention are described below by specific embodiments, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification.
现在参考附图介绍本发明的示例性实施方式,然而,本发明可以用许多不同的形式来实施,并且不局限于此处描述的实施例,提供这些实施例是为了详尽地且完全地公开本发明,并且向所属技术领域的技术人员充分传达本发明的范围。对于表示在附图中的示例性实施方式中的术语并不是对本发明的限定。在附图中,相同的单元/元件使用相同的附图标记。Exemplary embodiments of the present invention will now be described with reference to the accompanying drawings, however, the present invention may be embodied in many different forms and is not limited to the embodiments described herein, which are provided for the purpose of this thorough and complete disclosure invention, and fully convey the scope of the invention to those skilled in the art. The terms used in the exemplary embodiments shown in the drawings are not intended to limit the invention. In the drawings, the same elements/elements are given the same reference numerals.
除非另有说明,此处使用的术语(包括科技术语)对所属技术领域的技术人员具有通常的理解含义。另外,可以理解的是,以通常使用的词典限定的术语,应当被理解为与其相关领域的语境具有一致的含义,而不应该被理解为理想化的或过于正式的意义。Unless otherwise defined, terms (including scientific and technical terms) used herein have the commonly understood meanings to those skilled in the art. In addition, it is to be understood that terms defined in commonly used dictionaries should be construed as having meanings consistent with the context in the related art, and should not be construed as idealized or overly formal meanings.
第一实施例first embodiment
如图1所示,本发明第一实施例公开了一种扩张球囊导管,包括穿设于导管1和导管1内部的导丝2,导管1一端固定连接有操作部3,在远离操作部3的导管1的远端外侧中有一球囊4,导管1的腔体和球囊4的内腔之间由设置在导管1上的连通结构相连通,其中,导丝2包括相互分离的第一导丝21和第二导丝22,第一导丝21的后端通过插拔结构可插拔地连接于操作部3上,第二导丝22通过固定工艺固定于导管1的另一端。As shown in FIG. 1 , the first embodiment of the present invention discloses a dilatation balloon catheter, which includes a
导丝2包括相互分离的第一导丝21和第二导丝22,第一导丝21可通过操作部3上设置的插拔结构进行插拔,扩张球囊导管插入人体时,第一导丝21可通过操作部3上设置插拔结构插入导管腔体,导管腔体作为导丝腔穿设导丝,利用导丝进行引导插入,注液时便可将第一导丝21拔出,将导管腔体作为注液腔来注入液体,从而使得导丝腔和注液腔可共用同一个导管腔体,无需另外设置注液腔,或者无需在导丝表面另外设置保护膜对导丝进行保护,如此一来,大大减小了本实施例的扩张球囊导管的直径,从而使得本实施例的扩张球囊导管可通过内窥镜的器械通道插入人体内需要扩张的狭窄管体或者腔体人体内,实现可视化操作。The
其中,注入球囊的液体优选为生理盐水,当向导管内部注射生理盐水时,生理盐水由导管1后端进入,因导管1前端为封闭结构,生理盐水自设置于导管上的连通结构流出并蓄积在球囊4中,使得球囊4向外膨胀扩张,当从导管内部抽出生理盐水时,球囊4收缩回原始状态。Wherein, the liquid injected into the balloon is preferably physiological saline. When the physiological saline is injected into the catheter, the physiological saline enters from the rear end of the
其中,导管1内部为中空结构,且导管1的前端为封闭结构,导管1的后端为开口结构,导管1内部穿设引导导丝2,导管1腔体和球囊4内腔由设置在导管1上的连通结构相连通。The interior of the
具体地,如图1所示,本实施例中,导管1在球囊4中的管体区域中相互分离为第一管体11和第二管体12,第一管体11的后端固定连接于操作部3,第二管体12的外壁固定连接于球囊4,第一管体11和第二管体12之间的断面相对构成连通通道13,连通通道13作为连通结构将导管1腔体和球囊4内腔相连通。Specifically, as shown in FIG. 1 , in this embodiment, the
如图1中所示,第二导丝22的后端沿着导管1的轴线延伸插入第一管体11的内部,第二导丝22插入第一管体11内的插入深度大于在球囊4膨胀时第一管体11和所述第二管体12之间的分离距离,当第二管体12纵向向前位移时,第二导丝22随之一起纵向向前位移,第一管体11此时沿着导管1的轴线相对向后位移,由于第二导丝22自第二管体12内部延伸至第一管体11内部,且第二导丝22插入第一管体11内的插入深度大于在球囊4膨胀时第一管体11和所述第二管体12之间的分离距离,能够保证导管整体不会在导管的断面处弯曲变形,起到了良好的连接和引导作用。As shown in FIG. 1 , the rear end of the
本实施例中,由于导管1在球囊4所中的区域内分为两段,手术过程中在注液时,球囊4向外膨胀同时纵向伸长,第二管体12也可以随之纵向向前位移,这样可以使得球囊4不会因为导管的拉升形变而弯曲,球囊4在插入到诸如人体内输尿管之类的狭窄管体或者腔体后,可扩张均匀,使狭窄管体或者腔体各侧壁受力均匀。两段导管的分离设计避免了现有技术中的导管1为一个整体,在球囊4膨胀纵向伸长时,导管1变纵向拉伸形变,由于导管1和球囊4的材质不同,导管1的形变会使得膨胀后的球囊弯曲变形,导致球囊4扩张时表面的撑开力不均匀,使得人体内需要扩张的狭窄管体或者腔体各侧壁受力不均,造成诊疗的效果不佳,引起患者更多不适。In this embodiment, since the
第二导丝22插入第一管体11内,第二导丝22插入第一管体11内的插入深度大于在球囊4膨胀时第一管体11和所述第二管体12之间的分离距离。可以确保在球囊4膨胀时,第二导丝22不会从第一管体11内脱出,从而使得第一管体11和所述第二管体12在分离时基本保持在导管1的中轴线上,进一步确保球囊4膨胀时不会弯曲变形,使得需要扩张的狭窄管体或者腔体各侧壁受力更加均匀,大大提高诊疗的效果。The
连通通道13既可以作为连通结构将导管1腔体和球囊4内腔相连通,使得导丝腔和注液腔可共用同一个导管腔体,大大减小了本实施例的扩张球囊导管的直径,从而使得本实施例的扩张球囊导管可通过内窥镜的器械通道插入人体内需要扩张的狭窄管体或者腔体,实现可视化操作;也可以防止气囊4在注液膨胀时弯曲形变,具有很好的治疗效果。The
球囊4中的第一管体11的管壁上还设有一个或多个通孔14,通孔14作为连通结构连通第一管体11腔体和球囊4内腔。通孔14设置在第二导丝22插入第一管体11内的端部和第一管体11与球囊4的连接处之间,也就是说通孔14设置在第二导丝22插入第一管体11内的端部的靠近操作部3的一侧。The tube wall of the
此外,通孔14可作为连通结构将导管1腔体和球囊4相连通,使得导丝腔和注液腔可共用同一个导管腔体,大大减小了本实施例的扩张球囊导管的直径。并且,当第一导丝21通过连接于所述操作部3的插拔结构抽出第一管体11后进行注液时,第一导丝21和第二导丝22均不会阻挡通孔14,可以大大加快注液膨胀的速度。In addition, the through
优选地,如图1所示,在球囊4前端与第二管体12的相连接之处设有显影环5,在无法利用内窥镜的器械通道的情况下,为了确定球囊4在人体的管体或者腔体内部移动的准确位置,可以利用显影环通过X线造影录像技术确定球囊4在人体的管体或者腔体内的位置,从而监视人体的管体或者腔体内部的位置,达到诊疗的目的。Preferably, as shown in FIG. 1 , a developing
同样,本领域的技术人员也可以根据需要,在球囊4后端与导管1的相连接之处设有第二显影环(未示出),两个显影环的设置可以通过X线造影录像技术更清楚的确定球囊4在人体的管体或者腔体内的位置。Similarly, those skilled in the art can also provide a second imaging ring (not shown) at the connection between the rear end of the
进一步地,第二导丝22通过固定工艺来固定连接于显影环5的内侧,该固定工艺包括胶水固定或者热熔固定,也可以利用其它的固定结构或者固定元器件来将两者进行固定连接。Further, the
进一步地,显影环5包覆区域的导管的内部封闭,使得注入的液体不能进入显影环的前方,只能停留在显影环5后方的球囊内部,加快了注液的速度,从而进一步缩短了手术的时间。Further, the interior of the catheter in the area covered by the developing
本实施例中,显影环5与操作部3之间的导管的材料通常可采用PEEK,也可以用尼龙、聚烯胺等材料,优选PEEK材料;PEEK材料具有直径细且刚性佳的优点,使得显影环后方的导管尺寸可达到0.6~1.5毫米,优选为0.7~1.0毫米,最优0.8mm;导管的邵氏硬度可达到50D~95D;优选80D~90D。采用PEEK材料可在保证导管引导作用的同时,进一步减小导管的直径,从而提高诊疗效果,减少患者的痛苦。In this embodiment, the material of the catheter between the developing
较佳地,如图1所示,导管1远离操作部3的一侧可以设置尖端导管23,第二导丝22延伸至尖端导管23内,该尖端导管23前端超过第二导丝22顶部大约0.5mm-2mm,即第二导丝22位于所述尖端导管23中的端部到显影环前端的尖端导管23顶端的距离为0.5mm-2mm,本发明实施例中,尖端导管23的材质为柔软的高分子材料,优选为TPU。将尖端导管23采用柔软材质,可以避免坚硬材质插入对输尿管内壁造成损伤,提高了手术成功的概率,同时由于尖端导管23内部还包括部分的第二导丝22,使得其具有一定的刚性,能够引导导管插入人体内部。其中,尖端导管23前端超过导丝顶部的长度范围为0.5mm-2mm,若长度小于0.5mm,第二导丝22插入过程中容易戳破导管顶端,若长度大于2mm,则导管前端会由于太过于柔软而无法插入,因此0.5mm-2mm的长度为合适的范围。Preferably, as shown in FIG. 1 , a
进一步地,还可以将上述尖端导管23的端部设置为球状体结构,球状体结构的光滑球面设计能够引导导管插入人体内部细长状的导管插入对人体内管体或者腔体壁面的损伤。Further, the end of the above-mentioned
如图1所示,本发明第一实施例中,在球囊4后端的导管1外周面上还设有刻度线,刻度线可以是等距离的刻度线,这样可以通过内窥镜的显影来观测球囊4的插入深度,传统的是通过X射线来确定显影环的位置来确定球囊的位置。因此,本发明实施例中可以只设置有一个显影环5作为备用,通常情况下就利用内窥镜显影和刻度来确定位置,只有在刻度线看不清楚时可利用显影环5辅助X射线来确定导管插入的准确位置。As shown in FIG. 1 , in the first embodiment of the present invention, a scale line is also provided on the outer peripheral surface of the
较佳地,操作部3前方的导管1外壁上设有刻度标识,如图1中所示的60cm,80cm和100cm,用于标识导管进入人体内部腔道的距离,操作者可通过刻度标识直观地观察到导管插入的长度。Preferably, the outer wall of the
优选地,本实施例的导丝2为金属导丝,金属导丝可以用镍钛合金或不锈钢等金属材料,进一步优选为镍钛合金。镍钛合金是一种形状记忆合金,形状记忆合金是能将自身的塑性变形在某一特定温度下自动恢复为原始形状的特种合金。它的伸缩率在20%以上,疲劳寿命达1*10的7次方,阻尼特性比普通的弹簧高10倍,其耐腐蚀性优于目前最好的医用不锈钢,因此可以满足各类工程和医学的应用需求,是一种非常优秀的功能材料。记忆合金除具有独特的形状记忆功能外,还具有耐磨损、抗腐蚀、高阻尼和超弹性等优异特点。利用镍钛合金作为金属导丝,可大大延长器械的使用寿命,降低器械损耗率。Preferably, the
如图3所示,本实施例的扩张球囊导管的操作部3包括手持部31,导管穿设于手持部31的内部,形成连通于球囊4内腔的注射液体通道。手持部31的设计便于手术操作者握持进行操作。进一步地,从图1中可知,手持部31为圆锥状体结构,即如图中所示的手持部31自后端相前端直径逐渐平滑过渡减小的形状体,该圆锥状体结构的设计符合人体工学设计,使得操作者握持扩张球囊导管进行操作时更为方便和舒适。本领域技术人员可以想到的是,该手持部31的形状并不限于本实施例中所列举的圆锥体状,还可以为其他便于手持操作的形状设计。As shown in FIG. 3 , the operating
优选地,在手持部31的后端设置由二通旋塞32,二通旋塞32的塞子上设有旋塞通孔,旋转二通旋塞的塞子,当旋塞通孔于导管1的管口同轴时,可打开液体通道;当旋塞通孔于导管1的管口垂直时,可关闭液体通道。如图1中所示,二通旋塞32通过螺帽固定于手持部的后端,在二通旋塞32上连接注射器具,当旋转二通旋塞打开液体通道时,可通过注射器具相导管腔体内部注入液体,实践中,注射器具可实用20个大气压的注水泵;当旋转二通旋塞关闭液体通道时,一方面可防止外界的污染物、粉尘等通过导管1进入输尿管,引起输尿管内壁薄膜感染,另一方面,可保持扩张压力防止球囊4中的液体流出,使得封堵球囊4形状稳定。二通旋塞32的设计与现有的注射结构相比,因现有的注射结构需要通过手柄或其他结构的推拉来控制注射入口的打开或关闭,其手柄与导管间的连接为非固定的,通过不断的推拉手柄时,手柄容易损坏;而本发明的二通导管32是通过旋转的动作来进行液体通道的打开和关闭,结构简单,易于操作,且延长了器械使用寿命。Preferably, a two-
如图3中所示,手持部31和二通旋塞32的末端均为标准的null接口,可用于外接注水泵等注射器具。Null接口通用性较强,可配置不同的器具。As shown in FIG. 3 , the ends of the
进一步地,操作部3的后端还设有外螺纹33,外螺纹33可套接螺丝帽35,螺丝帽作为插拔结构与第一导丝21的后端相连接,使得手术过程中,操作者可拧转螺丝帽32来带动第一导丝21外移,从而拔出第一导丝;或者插入第一导丝之后,拧转螺丝帽35使之固定于外螺纹33上。本领域技术人员可以想到,第一导丝21的插拔结构不仅仅限于本实施例所提供的螺丝帽,还包括其他可实现相同功能的插拔结构。Further, the rear end of the
如图3所示,操作部3还包括应力扩散管34,应力扩散管34设置在手持部31的前端,导管1穿设于应力扩散管34的内部。其作用是避免导管1从基部处的应力过大而损伤,也提高了操作者的操作手感,防止器械耗损造成的成本损失。应力扩散管为圆筒状或内部中空的圆锥体状,圆锥体状有后向前外径逐渐缩小,能够与手持部31在形状上平滑过渡衔接,受力更为均匀,并且外观更为美观。As shown in FIG. 3 , the operating
第二实施例Second Embodiment
本发明第二实施例公开一种扩张球囊导管,包括穿设于导管1内部的导丝2,导管1一端固定连接有操作部3,在远离操作部3的导管1的远端外侧中有一球囊4,导管1腔体和球囊4内腔由设置在导管1上的连通结构相连通,导丝2包括相互分离的第一导丝21和第二导丝22,第一导丝21的后端连接于操作部3后端的插拔结构,第二导丝22通过固定工艺固定于导管1内部。The second embodiment of the present invention discloses a dilatation balloon catheter, which includes a
本实施例是第一实施例的变形例,如图2所示,本实施例与第一实施例的不同之处在于:导管1远离所述操作部3的一侧设置尖端导管23,第二导丝22远离操作部3延伸至尖端导管23的外部,第二导丝22的位于尖端导管23外部的部分设置为球状体结构6,即第二导丝22的头部焊接或一体形成球状体结构6,即形成带有球头的导丝。This embodiment is a modification of the first embodiment. As shown in FIG. 2 , the difference between this embodiment and the first embodiment is that a
这样可达到以下效果:1.减少导管材料,降低成本;2.较细的导丝在插入过程中更好地起到引导作用;3.球状体结构的设计最大程度地避免了细长状的导丝插入对输尿管内壁的摩擦损伤。优选地,导丝2为金属导丝,金属导丝可以用镍钛合金或不锈钢等金属材料,进一步优选为镍钛合金。镍钛合金是一种形状记忆合金,形状记忆合金是能将自身的塑性变形在某一特定温度下自动恢复为原始形状的特种合金。它的伸缩率在20%以上,疲劳寿命达1*10的7次方,阻尼特性比普通的弹簧高10倍,其耐腐蚀性优于目前最好的医用不锈钢,因此可以满足各类工程和医学的应用需求,是一种非常优秀的功能材料。记忆合金除具有独特的形状记忆功能外,还具有耐磨损、抗腐蚀、高阻尼和超弹性等优异特点。利用镍钛合金作为金属导丝,可大大延长器械的使用寿命,降低器械损耗率。In this way, the following effects can be achieved: 1. Reduce catheter material and reduce costs; 2. The thinner guide wire can better guide the insertion process; 3. The design of the spherical body structure minimizes the elongated shape Frictional injury to the inner wall of the ureter caused by guidewire insertion. Preferably, the
综上所述,本发明所涉及的扩张球囊导管,包括相互分离的第一导丝和第二导丝,第一导丝可通过导管后端的开口进行插拔,从而使得导丝腔和注液腔可共用同一个导管腔体,无需另外设置注液腔,或者无需在导丝表面另外设置保护膜对导丝进行保护,如此大大减小了本发明的扩张球囊导管的直径,从而使得本发明的扩张球囊导管可通过内窥镜的器械通道插入人体内需要扩张的狭窄管体或者腔体,实现可视化操作,具有很好的实用价值。To sum up, the dilation balloon catheter involved in the present invention includes a first guide wire and a second guide wire that are separated from each other. The liquid cavity can share the same catheter cavity, and there is no need to set up another liquid injection cavity, or there is no need to set another protective film on the surface of the guide wire to protect the guide wire, which greatly reduces the diameter of the dilation balloon catheter of the present invention, thereby The expansion balloon catheter of the present invention can be inserted into the narrow tube body or cavity that needs to be expanded in the human body through the instrument channel of the endoscope, so as to realize visual operation, and has good practical value.
本发明所涉及的扩张球囊导管可用于泌尿系统(输尿管),消化系统(胆管,胰管)呼吸系统(气道)人体腔道狭窄的扩张,但不限于此,本发明所涉及的扩张球囊导管也可以作为封堵装置使用,例如,导管1的前端从输尿管壁和结石之间的缝隙插入,达到结石的上游甚至达到宽大的肾盂腔时,还可以自导管后端的开口处拔出第一导丝,将导管作为注液腔来注入生理盐水,使得进入结石上游或者肾盂腔的球囊4扩张,在结石上游输尿管腔内膨胀和封堵,使得下游的结石碎片还有冲洗液体无法进入肾盂腔,防止输尿管碎石上逸;或者在肾盂腔的球囊扩张后,将导管1的近端适当牵拉后封堵住肾盂输尿管交界处的肾盂出口,使得任何输尿管的结石、结石碎片、冲洗液体均无法进入肾盂腔,随后进行输尿管结石的碎石处理,如进行激光光纤碎石,待结石处理完毕后抽取球囊内的液体,然后抽出导管。实际操作中,可选择多次扩张球囊来调节球囊大小,使得球囊更好地与输尿管内壁贴合,紧密封堵输尿管结石,防止输尿管碎石上逸,便于手术操作,提高碎石成功率。。The dilatation balloon catheter involved in the present invention can be used for the expansion of the urinary system (ureter), the digestive system (bile duct, pancreatic duct), respiratory system (airway), and the narrowing of human lumen, but not limited to this, the dilatation balloon involved in the present invention The balloon catheter can also be used as a occlusion device. For example, the front end of the
此外,本发明所上述实施例仅例示性说明本发明的原理及其功效,而非用于限制本发明。任何本领域技术人员皆可在不违背本发明的精神及范畴下,对上述实施例进行修饰或改变。因此,本领域技术人员在未脱离本发明所揭示的精神与技术思想下所完成的一切等效修饰或改变,仍应由本发明的权利要求所涵盖。In addition, the above-mentioned embodiments of the present invention merely illustrate the principles and effects of the present invention, but are not intended to limit the present invention. Any person skilled in the art can modify or change the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or changes made by those skilled in the art without departing from the spirit and technical idea disclosed in the present invention should still be covered by the claims of the present invention.
Claims (9)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710963270.6A CN107596539B (en) | 2017-10-17 | 2017-10-17 | Balloon dilatation catheter |
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Cited By (1)
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| TWI725903B (en) | 2020-08-04 | 2021-04-21 | 賴銘曉 | Fluid pressure gun device for balloon catheter |
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| US11839729B2 (en) * | 2018-10-05 | 2023-12-12 | Acclarent, Inc. | Dilation instrument with malleable guide and dilation catheter with integral position sensor |
| CN111345927A (en) * | 2018-12-20 | 2020-06-30 | 上海微创医疗器械(集团)有限公司 | Sacculus, sacculus connection structure and sacculus device |
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| CN110448364A (en) * | 2019-09-11 | 2019-11-15 | 广州启骏生物科技有限公司 | Puncturing hole auxiliary expanding equipment and puncturing operation system |
| CN111588971A (en) * | 2020-06-03 | 2020-08-28 | 刘卫辉 | Appendix intubator |
| CN114668956B (en) * | 2020-12-24 | 2024-05-03 | 赖铭晓 | Fluid pressure gun device for balloon catheter |
| CN113082469B (en) * | 2021-04-15 | 2022-12-13 | 深圳泰睿仕医疗科技有限公司 | Ureter sacculus expansion pipe external member |
| CN114532944B (en) * | 2022-03-28 | 2025-09-12 | 优尔爱(常州)医疗科技有限公司 | Endoscopic balloon and endoscope device having the same |
| CN116725622A (en) * | 2023-03-23 | 2023-09-12 | 浙江桐轩医疗科技有限公司 | Size-adjustable stone-taking balloon easy and convenient to operate |
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| TWI725903B (en) | 2020-08-04 | 2021-04-21 | 賴銘曉 | Fluid pressure gun device for balloon catheter |
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Application publication date: 20180119 Assignee: ANQING MEDICAL Co.,Ltd. Assignor: Shanghai innova Medical Instrument Co.,Ltd. Contract record no.: X2024310000043 Denomination of invention: A dilating balloon catheter Granted publication date: 20200103 License type: Common License Record date: 20240417 |
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Denomination of invention: A dilating balloon catheter Granted publication date: 20200103 Pledgee: Shanghai Pudong Development Bank Co.,Ltd. Waigaoqiao Bonded Zone Branch Pledgor: Shanghai innova Medical Instrument Co.,Ltd. Registration number: Y2024310000387 |
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Address after: 201201, 2nd Floor, Building 17, No. 315 Qingda Road, Pudong New Area, Shanghai Patentee after: Shanghai innova Medical Instrument Co.,Ltd. Country or region after: China Address before: 201210 east of 1st and 2nd floors, building 7, No. 150 Cailun Road, Pudong New Area, Shanghai Patentee before: Shanghai innova Medical Instrument Co.,Ltd. Country or region before: China |
