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CN115040764A - Novel urethra dilator - Google Patents

Novel urethra dilator Download PDF

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Publication number
CN115040764A
CN115040764A CN202210693802.XA CN202210693802A CN115040764A CN 115040764 A CN115040764 A CN 115040764A CN 202210693802 A CN202210693802 A CN 202210693802A CN 115040764 A CN115040764 A CN 115040764A
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Prior art keywords
guide wire
film sleeve
ball head
head structure
film
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CN115040764B (en
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张莉
江璐
程建云
武云
陈瑞
谢玉莹
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First Affiliated Hospital of Xinjiang Medical University
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First Affiliated Hospital of Xinjiang Medical University
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02Dilators made of swellable material
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/10Trunk
    • A61M2210/1078Urinary tract

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

A novel urethral dilator comprising: the guide wire is provided with a ball head structure at the head end of the guide wire, and the maximum diameter of the ball head structure is larger than the diameter of the guide wire; the expandable catheter assembly comprises a sleeve-shaped film sleeve, the film sleeve is sleeved on the outer side of the guide wire and wound in the accommodating space, the front end of the film sleeve is adhered to the ball head structure, and the rear end of the film sleeve is provided with an injection port. In the invention, the structure design of the middle channel formed after the thin film sleeve is expanded can avoid the problem that the urethra is damaged by the original hollow dilator. The invention can also ensure that the expander keeps smaller volume and integral strength in the entering process. The thin film sleeve is designed, the volume structure of the dilator is changed through the thin film sleeve, and after the dilator enters a human body to be positioned, the thin film sleeve can be expanded and keeps the structural form of the dilator, so that the middle channel is kept in an open state, and the success rate of catheterization is increased.

Description

一种新型尿道扩张器A new type of urethral dilator

技术领域technical field

本发明涉及医疗辅助器械技术领域,更具体地说,涉及一种新型尿道扩张器,特别适用于妇科以及泌尿科使用。The invention relates to the technical field of medical aids, and more particularly, to a novel urethral dilator, which is especially suitable for gynecology and urology.

背景技术Background technique

目前泌尿外科经尿道手术后,由于医源性尿道损伤增加,尿道狭窄病人增加,所以病人需要定期进行尿道扩张治疗,而在临床操作过程中,以往的实心尿道扩张器完全需要操作者靠手感及经验来判断是否尿道扩张器到达膀胱,而无明确证据尿道扩张过程中是不是走错路,导致尿道假道形成,增加治疗创伤。以往有空心的尿道扩张器,在治疗过程中出现过扩张器弯曲,扩张器开口过大,损伤尿道粘膜,同样增加了治疗创伤。At present, after transurethral surgery in urology, due to the increase of iatrogenic urethral injury and the increase of patients with urethral stricture, patients need to undergo urethral dilation treatment regularly. During clinical operation, the previous solid urethral dilator completely requires the operator to rely on the touch and feel of the urethra. Experience can be used to judge whether the urethral dilator reaches the bladder, but there is no clear evidence whether the urethral dilation process is going the wrong way, resulting in the formation of a false urethra and increasing the trauma of the treatment. In the past, there was a hollow urethral dilator. During the treatment process, the dilator was bent, and the opening of the dilator was too large, which damaged the urethral mucosa and also increased the treatment trauma.

因此,亟需提供一种扩张效果好、结构强度好、不易产生创伤的尿道扩张器。Therefore, there is an urgent need to provide a urethral dilator with good expansion effect, good structural strength, and less trauma.

发明内容SUMMARY OF THE INVENTION

(一)技术问题(1) Technical problems

本发明的目的在于针对现有技术的缺陷和不足,提供一种扩张效果好、结构强度好、不易产生创伤的带通道结构的尿道扩张器。The purpose of the present invention is to provide a urethral dilator with a channel structure that has good expansion effect, good structural strength, and is not easy to cause trauma, aiming at the defects and deficiencies of the prior art.

(二)技术方案(2) Technical solutions

本发明提供了一种新型尿道扩张器,在本发明中,该新型尿道扩张器包括:The present invention provides a novel urethral dilator. In the present invention, the novel urethral dilator includes:

导丝,于所述导丝的头端设置有球头结构,所述球头结构的最大直径大于所述导丝的直径,在垂直于所述导丝的轴向截面上,所述球头结构与所述导丝之间形成有容纳空间;A guide wire, a ball head structure is arranged at the head end of the guide wire, the maximum diameter of the ball head structure is larger than the diameter of the guide wire, and on an axial section perpendicular to the guide wire, the ball head An accommodation space is formed between the structure and the guide wire;

可膨胀导管组件,所述可膨胀导管组件包括有套筒形的薄膜套管,所述薄膜套管套设于所述导丝的外侧并收卷在所述容纳空间中,所述薄膜套管的前端与所述球头结构粘连,所述薄膜套管的后端设置有注入端口、用于注入使所述薄膜套管膨胀的流体。An expandable catheter assembly, the expandable catheter assembly includes a sleeve-shaped film sleeve, the film sleeve is sleeved on the outer side of the guide wire and wound in the accommodating space, the film sleeve The front end of the film sleeve is adhered to the ball head structure, and the rear end of the film sleeve is provided with an injection port for injecting the fluid that expands the film sleeve.

优选地,在本发明所提供的新型尿道扩张器中,于所述薄膜套管的后端设置有用于改变所述薄膜套管内所述流体电压的电组件;所述流体为电流变液。Preferably, in the novel urethral dilator provided by the present invention, an electrical component for changing the voltage of the fluid in the thin-film cannula is provided at the rear end of the thin-film cannula; the fluid is an electrorheological fluid.

优选地,在本发明所提供的新型尿道扩张器中,所述导丝为钛合金导丝,所述球头结构为钛合金球头结构。Preferably, in the novel urethral dilator provided by the present invention, the guide wire is a titanium alloy guide wire, and the ball head structure is a titanium alloy ball head structure.

优选地,在本发明所提供的新型尿道扩张器中,所述球头结构设置于所述导丝的头端并与所述导丝为一体式结构。Preferably, in the novel urethral dilator provided by the present invention, the ball head structure is arranged at the head end of the guide wire and is an integral structure with the guide wire.

优选地,在本发明所提供的新型尿道扩张器中,所述球头结构为圆球球头结构或梭形球头结构;所述球头结构的外侧面为光滑平面。Preferably, in the novel urethral dilator provided by the present invention, the ball head structure is a spherical ball head structure or a fusiform ball head structure; the outer side of the ball head structure is a smooth plane.

优选地,在本发明所提供的新型尿道扩张器中,所述薄膜套管设置于所述导丝上并靠近所述球头结构的一端为套管前端,于所述薄膜套管的中间通道内并套管前端的位置设置有连接薄膜,所述连接薄膜的拉断强度小于所述薄膜套管的拉断强度,所述连接薄膜包括有头端侧边、尾端侧边以及中间段,所述头端侧边与所述球头结构粘连,所述尾端侧边与所述薄膜套管粘连,所述中间段的长度小于所述球头结构的最大半径。Preferably, in the novel urethral dilator provided by the present invention, one end of the film sleeve disposed on the guide wire and close to the ball head structure is the front end of the sleeve, which is located in the middle channel of the film sleeve. The position of the front end of the inner sleeve is provided with a connecting film, the tensile strength of the connecting film is smaller than that of the film sleeve, and the connecting film includes a head end side edge, a tail end side edge and a middle section, The side of the head end is adhered to the ball head structure, the side edge of the tail end is adhered to the film sleeve, and the length of the middle section is smaller than the maximum radius of the ball head structure.

优选地,在本发明所提供的新型尿道扩张器中,所述尾端侧边与所述薄膜套管的粘连强度大于所述连接薄膜的拉断强度并小于所述薄膜套管的拉断强度;所述头端侧边与所述球头结构的粘连强度小于所述连接薄膜的拉断强度。Preferably, in the novel urethral dilator provided by the present invention, the adhesion strength between the side edge of the tail end and the film sleeve is greater than the breaking strength of the connecting film and smaller than the breaking strength of the film sleeve ; The adhesion strength between the side edge of the head end and the ball head structure is less than the breaking strength of the connecting film.

优选地,在本发明所提供的新型尿道扩张器中,所述所述导丝的直径范围为2mm-3mm,所述球头结构的最大直径大于所述导丝的直径0.5mm-1mm。Preferably, in the novel urethral dilator provided by the present invention, the diameter of the guide wire ranges from 2 mm to 3 mm, and the maximum diameter of the ball head structure is larger than the diameter of the guide wire by 0.5 mm to 1 mm.

优选地,在本发明所提供的新型尿道扩张器中,所述薄膜套管在膨胀状态下,所述薄膜套管的外侧面直径范围为2mm-4mm,所述所述薄膜套管的内侧面直径范围为1mm-3mm,所述外侧面的直径与所述内侧面的直径差值范围为0.5mm-1.5mm。Preferably, in the novel urethral dilator provided by the present invention, when the film sleeve is in an expanded state, the diameter of the outer side of the film sleeve ranges from 2 mm to 4 mm, and the inner side of the film sleeve is in the range of 2 mm to 4 mm. The diameter ranges from 1 mm to 3 mm, and the difference between the diameter of the outer side surface and the diameter of the inner side surface ranges from 0.5 mm to 1.5 mm.

优选地,在本发明所提供的新型尿道扩张器中,于所述薄膜套管的后端设置有文丘里管结构。Preferably, in the novel urethral dilator provided by the present invention, a venturi tube structure is provided at the rear end of the film sleeve.

(三)有益效果(3) Beneficial effects

本发明提供了一种新型尿道扩张器,该新型尿道扩张器包括:导丝,于所述导丝的头端设置有球头结构,所述球头结构的最大直径大于所述导丝的直径,在垂直于所述导丝的轴向截面上,所述球头结构与所述导丝之间形成有容纳空间;可膨胀导管组件,所述可膨胀导管组件包括有套筒形的薄膜套管,所述薄膜套管套设于所述导丝的外侧并收卷在所述容纳空间中,所述薄膜套管的前端与所述球头结构粘连,所述薄膜套管的后端设置有注入端口、用于注入使所述薄膜套管膨胀的流体。The present invention provides a novel urethral dilator, the novel urethral dilator comprises: a guide wire, a ball head structure is arranged at the head end of the guide wire, and the maximum diameter of the ball head structure is larger than the diameter of the guide wire , on the axial section perpendicular to the guide wire, an accommodation space is formed between the ball head structure and the guide wire; an inflatable catheter assembly, the inflatable catheter assembly includes a sleeve-shaped membrane sleeve The film sleeve is sleeved on the outer side of the guide wire and wound in the accommodating space, the front end of the film sleeve is adhered to the ball head structure, and the rear end of the film sleeve is set There are injection ports for injecting the fluid that expands the thin film sleeve.

通过上述结构设计,本发明相对于现有技术取得了以下有益效果:Through the above-mentioned structural design, the present invention has achieved the following beneficial effects with respect to the prior art:

1、本发明提供的新型尿道扩张器能够改变其整体形态,在进入尿道的过程中保持较细的直径,进入人体到位后,薄膜套管可以注入流体膨胀,从而形成一个中部具有通道结构的套管结构。本发明融合了实心尿道扩张器和空心尿道扩张器的优势,解决尿道扩张治疗中不易判断出血及是否到达膀胱的问题,同时薄膜套管膨胀后所形成的中部通道结构设计能避免原有空心扩张器损伤尿道的问题,而且通道结构(薄膜套管膨胀后形成的通道结构)解决了顺入导丝困难所带来的个别病人扩张后导尿困难或无法导尿的问题;1. The novel urethral dilator provided by the present invention can change its overall shape, and maintain a relatively thin diameter during the process of entering the urethra. After entering the human body in place, the film sleeve can be injected with fluid to expand, thereby forming a sleeve with a channel structure in the middle. Tube structure. The invention integrates the advantages of the solid urethral dilator and the hollow urethral dilator, and solves the problem that it is difficult to judge the bleeding and whether it reaches the bladder during the urethral dilation treatment, and at the same time, the structure design of the middle channel formed by the expansion of the film sleeve can avoid the original hollow expansion. In addition, the channel structure (the channel structure formed after the expansion of the film sleeve) solves the problem of difficulty in catheterization or inability to catheterize after the expansion of individual patients caused by the difficulty of inserting the guide wire;

2、相比于现有技术中不带通道结构的尿道扩张器,本发明整体(薄膜套管的整体长度)由长度24cm改进为长度44cm,即对5Fr尿道扩张器主体部分延长的改进,这个改进不仅延长了扩张器的长度(长度增加,就拓展了扩张器的适用范围),同时还能够保证扩张器在进入过程中即保持了较小的体积,又保证了起整体强度;2. Compared with the urethral dilator without channel structure in the prior art, the overall length of the present invention (the overall length of the film sleeve) is improved from a length of 24cm to a length of 44cm, that is, the improvement of the extension of the main body of the 5Fr urethral dilator. The improvement not only prolongs the length of the dilator (the longer the length increases, the wider the scope of application of the dilator), but also ensures that the dilator maintains a small volume during the entry process and ensures the overall strength;

3、设计了薄膜套管,通过薄膜套管改变扩张器的体积结构,在扩张器进入人体定位后,可以使得薄膜套管膨胀扩张并保持其结构形态,使得中部通道保持打开状态,增加了导尿的成功率。3. The thin film sleeve is designed, and the volume structure of the dilator is changed through the thin film cannula. After the dilator enters the human body for positioning, the thin film cannula can be expanded and expanded and its structural shape can be maintained, so that the middle channel remains open, and the guide is increased. Urine success rate.

附图说明Description of drawings

图1为本发明一种实施例中新型尿道扩张器的结构示意简图。FIG. 1 is a schematic structural diagram of a novel urethral dilator in an embodiment of the present invention.

在图1中,部件名称与附图标记的对应关系为:In Figure 1, the corresponding relationship between component names and reference numerals is:

导丝1、球头结构2、薄膜套管3、电组件4、连接薄膜5、Guide wire 1, ball head structure 2, film sleeve 3, electrical assembly 4, connecting film 5,

文丘里管结构6。Venturi structure 6.

具体实施方式Detailed ways

下面结合附图和实施例对本发明的实施方式作进一步详细描述。以下实施例用于说明本发明,但不能用来限制本发明的范围。The embodiments of the present invention will be described in further detail below with reference to the accompanying drawings and examples. The following examples are intended to illustrate the present invention, but not to limit the scope of the present invention.

在本发明的描述中,除非另有说明,“多个”的含义是两个或两个以上;术语“上”、“下”、“左”、“右”、“内”、“外”、“前端”、“后端”、“头部”、“尾部”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本发明和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本发明的限制。此外,术语“第一”、“第二”、“第三”等仅用于描述目的,而不能理解为指示或暗示相对重要性。In the description of the present invention, unless otherwise stated, "plurality" means two or more; the terms "upper", "lower", "left", "right", "inner", "outer" The orientation or positional relationship indicated by , "front end", "rear end", "head", "tail", etc. are based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, not An indication or implication that the referred device or element must have a particular orientation, be constructed and operate in a particular orientation, is not to be construed as a limitation of the invention. Furthermore, the terms "first," "second," "third," etc. are used for descriptive purposes only and should not be construed to indicate or imply relative importance.

在本发明的描述中,需要说明的是,除非另有明确的规定和限定,术语“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接;可以是机械连接,也可以是电连接;可以是直接相连,也可以通过中间媒介间接相连。对于本领域的普通技术人员而言,可以具体情况理解上述术语在本发明中的具体含义。In the description of the present invention, it should be noted that, unless otherwise expressly specified and limited, the terms "connected" and "connected" should be understood in a broad sense, for example, it may be a fixed connection, a detachable connection, or an integral connection. Ground connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood in specific situations.

请参考图1,图1为本发明一种实施例中新型尿道扩张器的结构示意简图。Please refer to FIG. 1 , which is a schematic structural diagram of a novel urethral dilator according to an embodiment of the present invention.

本发明提供了一种新型尿道扩张器,在现有技术中,尿道扩张器分为两种,一种是带有导管通道的扩张器,另一种是实心扩张器。实心扩张器能够保证扩张器整体具有较高的结构强度,因此其能够做的比较细,在临床上更方便使用,但是实心扩张器仅仅具有扩张功能,无法实现在扩张的同时进行疏导、引流。带有导管通道的扩张器就是在扩张器上设置一条细长的通道结构,通过扩张器上设置的通道结构进行疏导、引流,但是这种扩张器由于设置有一条细长的通道结构,其整体的结构强度就比较低,需要通过增加扩张器的体积来保证其满足使用要求,但是,扩张器体积增加将会导致扩张器使用难度的增加,同时还会增加人体创伤风险。The present invention provides a novel urethral dilator. In the prior art, there are two types of urethral dilators, one is a dilator with a catheter channel, and the other is a solid dilator. The solid dilator can ensure the overall high structural strength of the dilator, so it can be made thinner and more convenient to use clinically. A dilator with a catheter channel is to set a slender channel structure on the dilator, and conduct drainage and drainage through the channel structure set on the dilator. However, this dilator is provided with a slender channel structure. The structural strength of the dilator is relatively low, and it is necessary to increase the volume of the dilator to ensure that it meets the requirements for use. However, the increase in the volume of the dilator will increase the difficulty of using the dilator and increase the risk of human trauma.

本发明针对上述两种扩张器所存在的结构缺陷,提供了一种具有新型结构的尿道扩张器,该扩张器能够改变自身体积,在进入人体时保持较细的直径,方便进入人体,在进入人体后可以扩张直径并形成一条通道结构,从而实现人体内体液(血块或者尿液)的疏导、引流。本发明所提供的新型尿道扩张器,特别适用于妇科以及泌尿科使用。Aiming at the structural defects of the above two dilators, the present invention provides a urethral dilator with a novel structure, which can change its own volume and maintain a relatively small diameter when entering the human body, which is convenient for entering the human body. After the human body, the diameter can be expanded and a channel structure can be formed, so as to realize the dredging and drainage of body fluids (blood clots or urine) in the human body. The novel urethral dilator provided by the invention is especially suitable for use in gynecology and urology.

具体地,本发明所提供的新型尿道扩张器结构如下,包括:Specifically, the structure of the novel urethral dilator provided by the present invention is as follows, including:

第一部分:导丝1。Part 1: Guide wire 1.

导丝1是本发明实现新型尿道扩张器进入人体并实现在尿道中推进的结构。The guide wire 1 is the structure of the present invention that realizes the novel urethral dilator entering the human body and advancing in the urethra.

导丝1是一条具有一定结构强度的丝状(细杆状)结构,优选地,导丝1还可以具备一定的弹性,这样在进入尿道时,并在尿道中推进的过程中如果与人体组织发生接触,导丝1会发生弹性形变,从而降低由于硬性接触而造成人体组织发生创伤的几率。The guide wire 1 is a wire-like (thin rod-like) structure with a certain structural strength. Preferably, the guide wire 1 can also have a certain elasticity, so that when entering the urethra and during the process of advancing in the urethra, if the guide wire 1 is in contact with human tissue, When the contact occurs, the guide wire 1 will undergo elastic deformation, thereby reducing the probability of trauma to the human tissue caused by the rigid contact.

在本发明中,导丝1可以采用钛合金材料制成,导丝1也可以采用不锈钢材料制成。导丝1的直径范围为2mm-3mm,具体可以是2.0mm、2.2mm、2.4mm、2.6mm、2.8mm、3.0mm。In the present invention, the guide wire 1 can be made of titanium alloy material, and the guide wire 1 can also be made of stainless steel material. The diameter of the guide wire 1 ranges from 2 mm to 3 mm, and may specifically be 2.0 mm, 2.2 mm, 2.4 mm, 2.6 mm, 2.8 mm, and 3.0 mm.

为了方便导丝1进入人体,同时,避免导丝1头部与人体接触而造成人体组织划伤、戳破等问题的出现,本发明于导丝1的头端设置了一个球头结构2。球头结构2根据导丝1尺寸进行设计,在本发明中,球头结构2的最大直径大于导丝1的直径0.5mm-1mm。In order to facilitate the entry of the guide wire 1 into the human body, and at the same time, to avoid problems such as scratching and puncturing of human tissue caused by the head of the guide wire 1 contacting the human body, the present invention provides a ball head structure 2 at the head end of the guide wire 1 . The ball head structure 2 is designed according to the size of the guide wire 1 . In the present invention, the maximum diameter of the ball head structure 2 is larger than the diameter of the guide wire 1 by 0.5 mm-1 mm.

球头结构2(球头结构2可以为圆形球头,也可以为梭形球头结构2)的最大直径大于导丝1的直径(导丝1为等直径细长杆),在垂直于导丝1的轴向截面上,球头结构2与导丝1之间形成有容纳空间。上述结构更为形象的解释如下:对导丝1以及球头结构2在平行于导丝1轴向上进行投影,球头结构2为一个圆形投影,导丝1为一个圆形投影,球头结构2投影完全覆盖住导丝1投影,并且,球头结构2投影与导丝1投影同心,球头结构2投影的外缘与导丝1投影的外缘之间为一个环形区域,这个环形区域就可以理解为容纳空间的投影。The maximum diameter of the ball head structure 2 (the ball head structure 2 can be either a round ball head or a shuttle ball head structure 2) is larger than the diameter of the guide wire 1 (the guide wire 1 is a slender rod of equal diameter). On the axial section of the guide wire 1 , an accommodation space is formed between the ball head structure 2 and the guide wire 1 . A more vivid explanation of the above structure is as follows: the guide wire 1 and the ball head structure 2 are projected on the axis parallel to the guide wire 1, the ball head structure 2 is a circular projection, the guide wire 1 is a circular projection, and the ball head structure 2 is a circular projection. The projection of the head structure 2 completely covers the projection of the guide wire 1, and the projection of the ball head structure 2 is concentric with the projection of the guide wire 1. There is an annular area between the outer edge of the projection of the ball head structure 2 and the outer edge of the projection of the guide wire 1. The annular area can be understood as the projection of the accommodation space.

在使用时,导丝1设置有球头结构2的一端从人体的尿道口通过尿道进入到人体膀胱中,从而实现整条尿道的扩张。导丝1的另一端(不设置球头结构2的一端)则位于人体外,以方便导丝1的抽出(从薄膜套管3中抽出),另外,还可以对导丝1的另一端施加作用力,使得导丝1进行小幅度的往复运动,以实现对尿道中栓块(血块)的打碎。In use, one end of the guide wire 1 provided with the ball head structure 2 enters the human bladder from the urethral opening of the human body through the urethra, thereby realizing the expansion of the entire urethra. The other end of the guide wire 1 (the end without the ball head structure 2) is located outside the human body to facilitate the extraction of the guide wire 1 (from the film sleeve 3). The force causes the guide wire 1 to perform a small reciprocating motion, so as to break the plug (blood clot) in the urethra.

具体地,导丝1为钛合金导丝1,球头结构2为钛合金球头结构2。Specifically, the guide wire 1 is a titanium alloy guide wire 1 , and the ball head structure 2 is a titanium alloy ball head structure 2 .

具体地,球头结构2设置于导丝1的头端并与导丝1为一体式结构。进一步地,球头结构2为圆球球头结构2或梭形球头结构2,球头结构2的外侧面为光滑平面。Specifically, the ball head structure 2 is disposed at the head end of the guide wire 1 and is an integral structure with the guide wire 1 . Further, the ball head structure 2 is a round ball head structure 2 or a shuttle ball head structure 2, and the outer side surface of the ball head structure 2 is a smooth plane.

本发明在导丝1的头端设置了球头结构2,球头结构2的外侧面应当为平滑表面结构,这样在与人体组织接触时,不会对人体组织造成伤害,同时,导丝1在尿道中移动时,尿道管壁还能够很好地对球头结构2起到导向作用。具体地,球头结构2有两种优选结构,一种是圆球头结构2,另一种是梭形结构,在采用梭形结构时,球头结构2的两个尖端均为球面结构,其中一个尖端与导丝1固定连接(在该尖端根据导丝1的直径打出一个小孔,将导丝1的端部插入到小孔中然后焊接,再将连接部位打磨平滑)。In the present invention, the head end of the guide wire 1 is provided with a ball head structure 2, and the outer side of the ball head structure 2 should be a smooth surface structure, so that when it is in contact with human tissue, it will not cause damage to human tissue. At the same time, the guide wire 1 When moving in the urethra, the urethral tube wall can also well guide the ball head structure 2 . Specifically, the ball head structure 2 has two preferred structures, one is a round ball head structure 2, and the other is a shuttle-shaped structure. When the shuttle-shaped structure is adopted, both tips of the ball head structure 2 are spherical structures. One of the tips is fixedly connected with the guide wire 1 (a small hole is punched at the tip according to the diameter of the guide wire 1, the end of the guide wire 1 is inserted into the small hole and then welded, and the connection part is polished smooth).

在导丝1以及球头结构2采用钛合金材料作为制造材料的实施方式中,导丝1以及球头结构2的外表面无需设置任何的涂层,仅需要将其表面采用镜面打磨处理即可。In the embodiment in which the guide wire 1 and the ball head structure 2 are made of titanium alloy materials, the outer surfaces of the guide wire 1 and the ball head structure 2 do not need to be provided with any coating, and only need to be mirror-polished. .

第二部分:可膨胀导管组件。Part II: Expandable catheter assembly.

可膨胀导管组件是一种受控变形可改变其体积(主要是改变其直径)的组件。An expandable catheter assembly is an assembly that changes its volume (mainly its diameter) by controlled deformation.

具体地,可膨胀导管组件包括有套筒形(套筒形是指薄膜套管3注入流体膨胀后的整体形状,采用套筒形能够实现尿道管的扩张膨胀,同时还能够形成一条通道结构,用于实现体液的疏导与引流)的薄膜套管3(薄膜套管3是指采用高分子薄膜材料制成的套管结构,薄膜套管3优先采用医用PVC材料制成,其整体尺寸较小,可以采用精工制造)。薄膜套管3采用非弹性(不具有弹性)的薄膜材料制成,其包括有内层膜以及外层膜,内层膜为直圆筒结构,外层膜为直圆筒结构,外层膜的直径大于内层膜的直径,内层膜套入到外层膜中,然后两端封口,封口处设置有多片小尺寸的扇形结构(扇形结构能够拼成一个圆环形结构),这样在薄膜套管3充入流体膨胀后,可以扇形结构限位使得整个薄膜套管3保持管状结构。进一步地,本发明还可以在内层膜的表面(朝向外侧面的一侧面上)设置于导丝1平行的支撑筋。Specifically, the expandable catheter assembly includes a sleeve shape (the sleeve shape refers to the overall shape of the film sleeve 3 after being injected with fluid and expanded, and the use of the sleeve shape can realize the expansion and expansion of the urethral tube, and can also form a channel structure, The film sleeve 3 (the film sleeve 3 refers to the sleeve structure made of polymer film material, the film sleeve 3 is preferably made of medical PVC material, and its overall size is small , can be manufactured by Seiko). The film sleeve 3 is made of an inelastic (non-elastic) film material, which includes an inner film and an outer film, the inner film has a straight cylindrical structure, the outer film has a straight cylindrical structure, and the outer film has a straight cylindrical structure. The diameter of the inner layer film is larger than the diameter of the inner layer film, the inner layer film is sleeved into the outer layer film, and then both ends are sealed, and there are multiple small-sized fan-shaped structures at the seal (the fan-shaped structure can be assembled into a circular structure), so that After the film sleeve 3 is filled with fluid and expanded, it can be limited in a fan-shaped structure so that the entire film sleeve 3 maintains a tubular structure. Further, in the present invention, a support rib parallel to the guide wire 1 can also be provided on the surface of the inner layer membrane (the side facing the outer side).

薄膜套管3套设于导丝1的外侧并收卷(排出流体状态下薄膜套管3相当于两篇柔性薄膜,可以任意收卷)在容纳空间中,薄膜套管3的前端与球头结构2粘连(采用粘连方式进行连接时,可以通过施加一定的作用力实现球头结构2与薄膜套管3分离),薄膜套管3的后端设置有注入端口、用于注入使薄膜套管3膨胀的流体。注入端口为一个硬质塑料或者橡胶材料制成构件,用于与承装流体的容器(例如注射器)进行对接,由容器对流体施加压力,从而将流体压入到薄膜套管3中以实现薄膜套管3的膨胀。The film sleeve 3 is sleeved on the outer side of the guide wire 1 and wound up (the film sleeve 3 is equivalent to two flexible films in the state of discharging fluid, and can be wound arbitrarily) in the accommodating space, the front end of the film sleeve 3 and the ball head The structure 2 is adhered (when using the adhesion method to connect, the ball head structure 2 can be separated from the film sleeve 3 by applying a certain force), and the rear end of the film sleeve 3 is provided with an injection port for injecting the film sleeve. 3 Expanded fluid. The injection port is a member made of hard plastic or rubber material, which is used for docking with a container (such as a syringe) containing fluid, and the container exerts pressure on the fluid, so as to press the fluid into the film sleeve 3 to realize the film Expansion of casing 3.

薄膜套管3膨胀后,中部能够形成一条通道结构,用于将人体体液引流出人体外,薄膜套管3的膨胀后,期结构强度较低,为了增加薄膜套管3膨胀后的整体结构强度,本发明提出了如下两个实施方式:1、增加薄膜套管3中流体的压力;2、改变流体性状(液态或者气态)使其变成固态。对于第一种方式而言,本发明可以选用任何对人体无害的流体,例如硅油、蒸馏水等,在第一种方式中,对薄膜套管3的结构强度要求较高。对于第二种方式而言,本发明限定流体为电流变液,电流变液是一种新型材料,常态(无电压加载状态下)为液态,有电压加载时就能够变成固态,并且性状改变时不改变其形状。基于上述第二种方式,本发明于薄膜套管3的后端设置有用于改变薄膜套管3内流体电压的电组件4。After the film sleeve 3 is expanded, a channel structure can be formed in the middle for draining the body fluids out of the human body. After the expansion of the film sleeve 3, the structural strength is relatively low. In order to increase the overall structural strength of the film sleeve 3 after the expansion , the present invention proposes the following two embodiments: 1. Increase the pressure of the fluid in the thin film sleeve 3; 2. Change the properties of the fluid (liquid or gas) to make it solid. For the first mode, the present invention can select any fluid that is harmless to the human body, such as silicone oil, distilled water, etc. In the first mode, the structural strength of the film sleeve 3 is required to be high. For the second method, the present invention defines the fluid as electrorheological fluid. Electrorheological fluid is a new type of material. It is liquid in normal state (in the state of no voltage loading), and can become solid when voltage is loaded, and its properties change. does not change its shape. Based on the above-mentioned second method, the present invention is provided with an electrical component 4 at the rear end of the film sleeve 3 for changing the fluid voltage in the film sleeve 3 .

进一步地,薄膜套管3设置于导丝1上并靠近球头结构2的一端为套管前端,于薄膜套管3的中间通道内并套管前端的位置设置有连接薄膜5,连接薄膜5的拉断强度小于薄膜套管3的拉断强度,连接薄膜5包括有头端侧边、尾端侧边以及中间段,头端侧边与球头结构2粘连,尾端侧边与薄膜套管3粘连,中间段的长度小于球头结构2的最大半径。Further, the film sleeve 3 is arranged on the guide wire 1 and one end close to the ball head structure 2 is the front end of the sleeve. The breaking strength of the film sleeve 3 is smaller than that of the film sleeve 3. The connecting film 5 includes a head end side edge, a tail end side edge and a middle section. The tube 3 is stuck, and the length of the middle section is less than the maximum radius of the ball head structure 2 .

在上述结构设计中,本发明设置了连接薄膜5,并对连接薄膜5提出了如下两方面限定:1、对于连接薄膜5的材料,结合薄膜套管3,对薄膜套管3以及连接薄膜5进行选材,以使得连接薄膜5的拉断强度小于薄膜套管3的拉断强度,这样在将导丝1抽出薄膜套管3时,连接薄膜5首先扯断,使得球头结构2与薄膜套管3分离;2、对于连接薄膜5的尺寸,在将头端侧边与球头结构2粘连、尾端侧边与薄膜套管3粘连后,连接薄膜5的中间段长度小于球头结构2的最大半径,这样在将连接薄膜5扯断后,在薄膜套管3的头端不会有连接薄膜5漏出来,以使得人体内体液顺利从薄膜套管3的头端进入到薄膜套管3的中部管道中流出。In the above-mentioned structural design, the present invention sets the connection film 5, and proposes the following two limitations for the connection film 5: 1. For the material of the connection film 5, in combination with the film sleeve 3, the film sleeve 3 and the connection film 5 are limited. Carry out material selection, so that the breaking strength of the connecting film 5 is less than the breaking strength of the film sleeve 3, so that when the guide wire 1 is pulled out of the film sleeve 3, the connecting film 5 is first torn off, so that the ball head structure 2 and the film sleeve are The tube 3 is separated; 2. For the size of the connecting film 5, after the side of the head end is adhered to the ball head structure 2 and the side of the tail end is adhered to the film sleeve 3, the length of the middle section of the connecting film 5 is smaller than that of the ball head structure 2 In this way, after the connecting film 5 is torn off, the connecting film 5 will not leak out at the head end of the film sleeve 3, so that the body fluid in the human body can smoothly enter the film sleeve 3 from the head end of the film sleeve 3 out of the middle pipe.

再进一步地,尾端侧边与薄膜套管3的粘连强度大于连接薄膜5的拉断强度并小于薄膜套管3的拉断强度,头端侧边与球头结构2的粘连强度小于连接薄膜5的拉断强度。在上述结构设计中,能够在将导丝1抽出时,首先是粘连结构发生断开,如果该断开失效,则连接薄膜5被扯断。Further, the adhesion strength between the side of the tail end and the film sleeve 3 is greater than the breaking strength of the connecting film 5 and less than the breaking strength of the film sleeve 3, and the adhesion strength between the side of the head end and the ball head structure 2 is smaller than that of the connecting film. 5 tensile strength. In the above-mentioned structural design, when the guide wire 1 is pulled out, the adhesive structure is disconnected first, and if the disconnection fails, the connecting film 5 is torn off.

具体地,薄膜套管3在膨胀状态下,薄膜套管3的外侧面直径范围为2mm-4mm(外侧面直径具体尺寸为2.0mm、2.2mm、2.4mm、2.6mm、2.8mm、3.0mm、3.2mm、3.4mm、3.6mm、3.8mm、4.0mm),薄膜套管3的内侧面直径范围为1mm-3mm(外侧面直径具体尺寸为1.0mm、1.2mm、1.4mm、1.6mm、1.8mm、2.0mm、2.2mm、2.4mm、2.6mm、2.8mm、3.0mm),外侧面的直径与内侧面的直径差值范围为0.5mm-1.5mm。Specifically, when the film sleeve 3 is in an expanded state, the diameter of the outer side of the film sleeve 3 ranges from 2mm to 4mm (the specific dimensions of the outer side diameter are 2.0mm, 2.2mm, 2.4mm, 2.6mm, 2.8mm, 3.0mm, 3.2mm, 3.4mm, 3.6mm, 3.8mm, 4.0mm), the diameter of the inner side of the film sleeve 3 is 1mm-3mm (specific dimensions of the outer side diameter are 1.0mm, 1.2mm, 1.4mm, 1.6mm, 1.8mm , 2.0mm, 2.2mm, 2.4mm, 2.6mm, 2.8mm, 3.0mm), the difference between the diameter of the outer side and the inner side is 0.5mm-1.5mm.

第三部分:文丘里管结构6。Part III: Venturi Structure 6.

作为本发明的另一个重点,本发明于薄膜套管3的后端设置有文丘里管结构6。As another key point of the present invention, the present invention is provided with a venturi tube structure 6 at the rear end of the film sleeve 3 .

具体地,文丘里管结构6包括有文丘里管主体,在文丘里管主体的细径段设置有一个对接口,同时本发明在薄膜套管3的尾端设置了硬质的管状结构,这样就可以通过文丘里管主体上设置的对接口安装到薄膜套管3尾端的硬质管状结构上。通过文丘里管能够使得薄膜套管3的中间通道结构形成负压,从而将体液、栓块等吸出。Specifically, the Venturi tube structure 6 includes a Venturi tube main body, and a butting port is provided at the narrow-diameter section of the Venturi tube main body, and at the same time, the present invention provides a rigid tubular structure at the tail end of the film sleeve 3, so that Then, it can be installed on the rigid tubular structure at the end of the film sleeve 3 through the docking port provided on the main body of the Venturi tube. A negative pressure can be formed in the middle channel structure of the film sleeve 3 through the Venturi tube, so as to suck out body fluids, plugs and the like.

本发明提供了一种新型尿道扩张器,该新型尿道扩张器包括:导丝1,于导丝1的头端设置有球头结构2,球头结构2的最大直径大于导丝1的直径,在垂直于导丝1的轴向截面上,球头结构2与导丝1之间形成有容纳空间;可膨胀导管组件,可膨胀导管组件包括有套筒形的薄膜套管3,薄膜套管3套设于导丝1的外侧并收卷在容纳空间中,薄膜套管3的前端与球头结构2粘连,薄膜套管3的后端设置有注入端口、用于注入使薄膜套管3膨胀的流体。The present invention provides a novel urethral dilator, the novel urethral dilator comprises: a guide wire 1, a ball head structure 2 is arranged at the head end of the guide wire 1, and the maximum diameter of the ball head structure 2 is larger than the diameter of the guide wire 1, On the axial section perpendicular to the guide wire 1, an accommodation space is formed between the ball head structure 2 and the guide wire 1; the expandable catheter assembly includes a sleeve-shaped film sleeve 3, and the film sleeve 3 is sleeved on the outside of the guide wire 1 and wound in the accommodating space, the front end of the film sleeve 3 is adhered to the ball head structure 2, and the rear end of the film sleeve 3 is provided with an injection port for injecting the film sleeve 3. expanding fluid.

通过上述结构设计,本发明相对于现有技术取得了以下有益效果:Through the above-mentioned structural design, the present invention has achieved the following beneficial effects with respect to the prior art:

1、本发明提供的新型尿道扩张器能够改变其整体形态,在进入尿道的过程中保持较细的直径,进入人体到位后,薄膜套管3可以注入流体膨胀,从而形成一个中部具有通道结构的套管结构。本发明融合了实心尿道扩张器和空心尿道扩张器的优势,解决尿道扩张治疗中不易判断出血及是否到达膀胱的问题,同时薄膜套管3膨胀后所形成的中部通道结构设计能避免原有空心扩张器损伤尿道的问题,而且通道结构(薄膜套管3膨胀后形成的通道结构)解决了顺入导丝1困难所带来的个别病人扩张后导尿困难或无法导尿的问题;1. The novel urethral dilator provided by the present invention can change its overall shape, maintain a relatively thin diameter in the process of entering the urethra, and after entering the human body in place, the film sleeve 3 can be injected with fluid to expand, thereby forming a middle part with a channel structure. Casing structure. The invention combines the advantages of a solid urethral dilator and a hollow urethral dilator, and solves the problem that it is difficult to judge the bleeding and whether it reaches the bladder during the urethral dilation treatment. At the same time, the structure design of the middle channel formed by the expansion of the film sleeve 3 can avoid the original hollow The dilator damages the urethra, and the channel structure (the channel structure formed after the expansion of the film sleeve 3) solves the problem of difficulty in catheterization or inability to catheterize individual patients after dilation caused by the difficulty in inserting the guide wire 1;

2、相比于现有技术中不带通道结构的尿道扩张器,本发明整体(薄膜套管3的整体长度)由长度24cm改进为长度44cm,即对5Fr尿道扩张器主体部分延长的改进,这个改进不仅延长了扩张器的长度(长度增加,就拓展了扩张器的适用范围),同时还能够保证扩张器在进入过程中即保持了较小的体积,又保证了起整体强度;2. Compared with the urethral dilator without channel structure in the prior art, the whole of the present invention (the overall length of the film sleeve 3) is improved from a length of 24cm to a length of 44cm, that is, the improvement of the extension of the main body of the 5Fr urethral dilator, This improvement not only prolongs the length of the dilator (the longer the length increases, the wider the scope of application of the dilator), but also ensures that the dilator maintains a small volume during the entry process and maintains the overall strength;

3、设计了薄膜套管3,通过薄膜套管3改变扩张器的体积结构,在扩张器进入人体定位后,可以使得薄膜套管3膨胀扩张并保持其结构形态,使得中部通道保持打开状态,增加了导尿的成功率。3. The film sleeve 3 is designed, and the volume structure of the dilator is changed through the film sleeve 3. After the dilator enters the human body for positioning, the film sleeve 3 can be expanded and expanded and its structural shape can be maintained, so that the middle channel remains open. Increased success rate of catheterization.

本发明的实施例是为了示例和描述起见而给出的,而并不是无遗漏的或者将本发明限于所公开的形式。很多修改和变化对于本领域的普通技术人员而言是显而易见的。选择和描述实施例是为了更好说明本发明的原理和实际应用,并且使本领域的普通技术人员能够理解本发明从而设计适于特定用途的带有各种修改的各种实施例。The embodiments of the present invention are presented for purposes of illustration and description, and are not intended to be exhaustive or to limit the invention to the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art. The embodiment was chosen and described in order to better explain the principles of the invention and the practical application, and to enable others of ordinary skill in the art to understand the invention for various embodiments with various modifications as are suited to the particular use.

Claims (10)

1.一种新型尿道扩张器,其特征在于,包括:1. a novel urethral dilator, is characterized in that, comprises: 导丝(1),于所述导丝的头端设置有球头结构(2),所述球头结构的最大直径大于所述导丝的直径,在垂直于所述导丝的轴向截面上,所述球头结构与所述导丝之间形成有容纳空间;A guide wire (1), a ball head structure (2) is provided at the head end of the guide wire, the maximum diameter of the ball head structure is larger than the diameter of the guide wire, and the axial section perpendicular to the guide wire is provided On the top, an accommodation space is formed between the ball head structure and the guide wire; 可膨胀导管组件,所述可膨胀导管组件包括有套筒形的薄膜套管(3),所述薄膜套管套设于所述导丝的外侧并收卷在所述容纳空间中,所述薄膜套管的前端与所述球头结构粘连,所述薄膜套管的后端设置有注入端口、用于注入使所述薄膜套管膨胀的流体。An expandable catheter assembly, the expandable catheter assembly includes a sleeve-shaped film sleeve (3), the film sleeve is sleeved on the outside of the guide wire and wound in the accommodating space, the The front end of the film sleeve is adhered to the ball head structure, and the rear end of the film sleeve is provided with an injection port for injecting the fluid for expanding the film sleeve. 2.根据权利要求1所述的新型尿道扩张器,其特征在于,2. The novel urethral dilator according to claim 1, characterized in that, 于所述薄膜套管的后端设置有用于改变所述薄膜套管内所述流体电压的电组件(4);An electrical component (4) for changing the voltage of the fluid in the film sleeve is arranged at the rear end of the film sleeve; 所述流体为电流变液。The fluid is an electrorheological fluid. 3.根据权利要求1所述的新型尿道扩张器,其特征在于,3. The novel urethral dilator according to claim 1, characterized in that, 所述导丝为钛合金导丝,所述球头结构为钛合金球头结构。The guide wire is a titanium alloy guide wire, and the ball head structure is a titanium alloy ball head structure. 4.根据权利要求3所述的新型尿道扩张器,其特征在于,4. The novel urethral dilator according to claim 3, characterized in that, 所述球头结构设置于所述导丝的头端并与所述导丝为一体式结构。The ball head structure is arranged at the head end of the guide wire and is an integral structure with the guide wire. 5.根据权利要求4所述的新型尿道扩张器,其特征在于,5. The novel urethral dilator according to claim 4, characterized in that, 所述球头结构为圆球球头结构或梭形球头结构;The ball head structure is a round ball head structure or a shuttle ball head structure; 所述球头结构的外侧面为光滑平面。The outer side of the ball head structure is a smooth plane. 6.根据权利要求1所述的新型尿道扩张器,其特征在于,6. The novel urethral dilator according to claim 1, characterized in that, 所述薄膜套管设置于所述导丝上并靠近所述球头结构的一端为套管前端,于所述薄膜套管的中间通道内并套管前端的位置设置有连接薄膜(5),所述连接薄膜的拉断强度小于所述薄膜套管的拉断强度,所述连接薄膜包括有头端侧边、尾端侧边以及中间段,所述头端侧边与所述球头结构粘连,所述尾端侧边与所述薄膜套管粘连,所述中间段的长度小于所述球头结构的最大半径。The film sleeve is arranged on the guide wire and one end close to the ball head structure is the front end of the sleeve, and a connecting film (5) is arranged in the middle channel of the film sleeve and at the position of the front end of the sleeve, The tensile strength of the connecting film is smaller than the tensile strength of the film sleeve, the connecting film includes a head end side edge, a tail end side edge and a middle section, the head end side edge and the ball head structure Adhesion, the side edge of the tail end is adhered to the film sleeve, and the length of the middle section is less than the maximum radius of the ball head structure. 7.根据权利要求6所述的新型尿道扩张器,其特征在于,7. The novel urethral dilator according to claim 6, characterized in that, 所述尾端侧边与所述薄膜套管的粘连强度大于所述连接薄膜的拉断强度并小于所述薄膜套管的拉断强度;The adhesion strength between the side edge of the tail end and the film sleeve is greater than the breaking strength of the connecting film and smaller than the breaking strength of the film sleeve; 所述头端侧边与所述球头结构的粘连强度小于所述连接薄膜的拉断强度。The adhesion strength between the side edge of the head end and the ball head structure is smaller than the breaking strength of the connecting film. 8.根据权利要求1所述的新型尿道扩张器,其特征在于,8. The novel urethral dilator according to claim 1, characterized in that, 所述所述导丝的直径范围为2mm-3mm,所述球头结构的最大直径大于所述导丝的直径0.5mm-1mm。The diameter of the guide wire ranges from 2 mm to 3 mm, and the maximum diameter of the ball head structure is larger than the diameter of the guide wire by 0.5 mm to 1 mm. 9.根据权利要求1所述的新型尿道扩张器,其特征在于,9. The novel urethral dilator according to claim 1, characterized in that, 所述薄膜套管在膨胀状态下,所述薄膜套管的外侧面直径范围为2mm-4mm,所述所述薄膜套管的内侧面直径范围为1mm-3mm,所述外侧面的直径与所述内侧面的直径差值范围为0.5mm-1.5mm。In the expanded state of the film sleeve, the diameter of the outer side of the film sleeve is in the range of 2mm-4mm, the diameter of the inner side of the film sleeve is in the range of 1mm-3mm, and the diameter of the outer side is the same as the diameter of the outer side. The diameter difference of the inner side surface ranges from 0.5mm to 1.5mm. 10.根据权利要求1至9任一项所述的新型尿道扩张器,其特征在于,10. The novel urethral dilator according to any one of claims 1 to 9, characterized in that, 于所述薄膜套管的后端设置有文丘里管结构(6)。A venturi tube structure (6) is arranged at the rear end of the film sleeve.
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