CN116965757A - Protective medical endoscope device and ureteral lithotripsy operation system - Google Patents
Protective medical endoscope device and ureteral lithotripsy operation system Download PDFInfo
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Abstract
Description
技术领域Technical field
本发明涉及一种防护型医用内窥镜装置及经输尿管碎石手术系统,属医疗器械产品技术领域。The invention relates to a protective medical endoscope device and a transureteral lithotripsy surgical system, and belongs to the technical field of medical device products.
背景技术Background technique
现有的医用内窥镜分为细长镜体不能或不易弯曲的硬镜、镜体易于弯曲的软镜、硬镜内套设软镜的组合内镜,硬镜因强度大但易于进入生命体的自然腔道或病理窦道等通道中,软镜虽有置入困难的缺陷,但软镜更为细长柔软可在操作中更长时间接触自然腔道且损伤较硬镜为小;比如经尿道的激光肾结石手术,通常是用1.硬镜由尿道进入膀胱及输尿管;2.随后经硬镜的工作通道插入导丝至肾盂;3.退出硬镜仅留导丝在泌尿道内;4.再经导丝置入输尿管鞘管及位于鞘管内的鞘芯;5.抽出输尿管鞘管内的鞘芯;6.再将软镜从输尿管鞘管内插入,开口于软镜头部的工作通道承担光纤碎石、冷却冲洗、结石套取等功能;置入软镜需要多个步骤,操作繁琐;且无论硬镜与软镜,在生命体自然腔道内推进时,内窥镜组件头部硬质边缘部分与自然腔道粘膜持续动态接触,剪切损伤难以避免,当遇到自然腔道狭窄处时这种剪切损伤更为严重,甚至发生穿孔;现有技术的置镜过程安全防护措施薄弱甚至无安全防护措施,自然腔道粘膜剪切损伤后易于继发感染及引发功能障碍。Existing medical endoscopes are divided into hard endoscopes with a slender body that cannot or are not easily bent, soft endoscopes with an easy-to-bend body, and combined endoscopes with a soft lens inside a hard endoscope. Hard endoscopes are strong but easy to enter life. Although soft scopes have the disadvantage of being difficult to insert into the body's natural orifice or pathological sinus passages, they are more slender and softer and can be in contact with the natural orifice for a longer period of time during operation and cause less damage than hard scopes; For example, transurethral laser kidney stone surgery usually uses 1. The rigid scope enters the bladder and ureter from the urethra; 2. Then inserts the guide wire through the working channel of the rigid scope to the renal pelvis; 3. Exits the rigid scope, leaving only the guide wire in the urinary tract. ; 4. Then insert the ureteral sheath and the sheath core inside the sheath through the guide wire; 5. Pull out the sheath core inside the ureteral sheath; 6. Then insert the flexible lens from the ureteral sheath and open into the working channel of the soft lens It undertakes functions such as fiber optic lithotripsy, cooling and flushing, and stone extraction; inserting a soft lens requires multiple steps and is cumbersome to operate; and regardless of whether the hard lens or the soft lens is advanced in the natural cavity of the living body, the head of the endoscope assembly is hard and The edge part of the substance is in continuous dynamic contact with the natural orifice mucosa, and shear damage is unavoidable. When encountering the narrow part of the natural orifice, the shear damage is more serious, and even perforation occurs; safety protection measures during the lens placement process in the existing technology Weak or even no safety protection measures, shear damage to the natural orifice mucosa is prone to secondary infection and dysfunction.
发明内容Contents of the invention
本发明提供一种防护型医用内窥镜装置及经输尿管碎石手术系统,内窥镜主体头部设有可膨胀囊体结构,镜鞘一体式头部防护,镜鞘一体式同步置入;柔性的囊体遮挡部结构全程避免硬质的鞘管主体头部边缘接触自然腔道柔嫩的粘膜,当本装置在自然腔道内推进遇到阻力时,从体外向囊体内腔充入流体使其膨胀径向柔性扩张自然腔道,解除充盈使囊体复原,此时扩张后的自然腔道尚未恢复原状态,继续推进则阻力最小,当遇到自然腔道狭窄时本发明的价值尤为突出,本发明在充分保障病患自然腔道安全的同时消除了繁琐步骤,提高了操作效率。The invention provides a protective medical endoscope device and a transureteral lithotripsy surgical system. The head of the main body of the endoscope is equipped with an expandable bladder structure, the scope sheath is integrated with the head protection, and the scope sheath is integrated and synchronously inserted; The flexible capsule shielding structure prevents the head edge of the hard sheath body from contacting the soft mucosa of the natural orifice. When the device encounters resistance when advancing in the natural orifice, fluid is filled from outside the body into the inner cavity of the capsule to make it The expansion radially flexibly expands the natural cavity, and the filling is released to restore the capsule. At this time, the expanded natural cavity has not yet returned to its original state. If it continues to advance, the resistance will be minimal. The value of the present invention is particularly prominent when the natural cavity is narrowed. The invention fully ensures the safety of the patient's natural orifice while eliminating cumbersome steps and improving operating efficiency.
本发明的目的是这样实现的:The purpose of the present invention is achieved as follows:
一种防护型医用内窥镜装置,细长的内窥镜主体上设有光学组件,内窥镜主体设有一贯穿头尾的工作通道,工作通道设有使用状态下进入体内的工作通道内开口及使用状态下位于体外的工作通道外开口;鞘管,细长的鞘管主体套接在内窥镜主体外,鞘管主体设有使用状态下进入体内的鞘管主体内开口及使用状态下位于体外的鞘管主体外开口,内窥镜主体头部顶端包覆有可膨胀的囊体,囊体由囊体连接部和囊体游离部构成,囊体连接部呈筒状与内窥镜主体头部外表面连接,囊体游离部为囊体可膨胀的部分,囊体游离部与内窥镜主体头部顶端之间的间隙形成囊体内腔;膨胀后的囊体游离部最大外径至少大于内窥镜主体头部外径;囊体游离部为透明状或至少与内窥镜主体头部顶端光学组件对应的区域为透明状;囊体内腔与工作通道连通;鞘管主体外开口处设有可与内窥镜尾部紧密连接的紧固机构,使用时,将内窥镜主体头部顶端从鞘管主体内开口探出,至少将头部顶端的囊体游离部一部分暴露在外,启动紧固机构使鞘管主体与内窥镜主体紧密连接,实现内窥镜和鞘管的同步进退;当内窥镜主体在生命体的自然腔道内前行遇阻时,可经工作通道外开口向囊体内腔充入流体使其膨胀,径向柔性扩张自然腔道狭窄处组织,便于内窥镜主体继续在自然腔道内前行;装置到达目标位置后松解紧固机构,内窥镜主体可在鞘管主体内自由旋转或前后移动。A protective medical endoscope device. The slender endoscope body is provided with optical components. The endoscope body is provided with a working channel that runs through the head and tail. The working channel is provided with an opening in the working channel that enters the body during use. And the outer opening of the working channel located outside the body when in use; the sheath, the slender sheath body is sleeved outside the endoscope body, and the sheath body is provided with an inner opening of the sheath body that enters the body in the use state. The main body of the sheath is opened outside the body. The top end of the head of the endoscope body is covered with an inflatable balloon. The balloon is composed of a balloon connection part and a free part of the balloon. The balloon connection part is cylindrical and connected with the endoscope. The outer surface of the main body head is connected, and the free part of the balloon is the expandable part of the balloon. The gap between the free part of the balloon and the top of the head of the endoscope body forms the inner cavity of the balloon; the maximum outer diameter of the free part of the balloon after expansion At least larger than the outer diameter of the endoscope body head; the free part of the capsule is transparent or at least the area corresponding to the optical component at the top of the endoscope body head is transparent; the inner cavity of the capsule is connected to the working channel; the outer opening of the sheath body is There is a fastening mechanism that can be tightly connected to the tail of the endoscope. When in use, the top of the head of the endoscope body is poked out of the opening in the sheath body, and at least part of the free part of the capsule at the top of the head is exposed. Activate the fastening mechanism to tightly connect the sheath body and the endoscope body to realize the synchronous advancement and retreat of the endoscope and the sheath; when the endoscope body encounters obstacles in the natural cavity of the living body, it can be moved outside the working channel. The opening fills the inner cavity of the balloon with fluid to expand it, and radially and flexibly expands the tissue in the narrow part of the natural lumen, allowing the endoscope body to continue moving forward in the natural lumen; after the device reaches the target position, the fastening mechanism is loosened, and the endoscope The body can freely rotate or move forward and backward within the sheath body.
囊体优选顺应性材料制作,可在径向柔性扩张自然腔道的同时向前延伸;囊体连接部呈筒状与内窥镜主体头部外表面的连接为易于分离的连接,以便暴露内窥镜主体工作通道进行随后的其他医疗操作;所述邻近鞘管主体外开口区域设有可与内窥镜尾部紧密连接的紧固机构,该紧固机构可以设置在鞘管主体尾部,也可以设置在内窥镜主体尾部,优选的设置在鞘管主体尾部;本发明中的防护型医用内窥镜装置涵盖内窥镜主体可弯曲的软镜及内窥镜主体不可弯曲的硬镜,涵盖电子镜及光学镜。The balloon body is preferably made of compliant material and can extend forward while flexibly expanding the natural cavity in the radial direction; the connection part of the balloon body is cylindrical and is connected to the outer surface of the endoscope body head in an easy-to-separate connection to expose the internal cavity. The working channel of the endoscope body is used for other subsequent medical operations; the area adjacent to the outer opening of the sheath body is provided with a fastening mechanism that can be closely connected to the tail of the endoscope. The fastening mechanism can be provided at the tail of the sheath body, or can be It is arranged at the tail of the endoscope body, preferably at the tail of the sheath body; the protective medical endoscope device in the present invention covers a flexible endoscope body with a flexible endoscope body and a hard endoscope body with an inflexible body. Electronic mirrors and optical mirrors.
为了满足部分临床需求,囊体游离部上与工作通道对应的区域为易于被导丝戳破的易损区域,易损区域上设置一个或多个易损结构。In order to meet some clinical needs, the area on the free part of the capsule corresponding to the working channel is a vulnerable area that is easily punctured by the guide wire, and one or more vulnerable structures are provided on the vulnerable area.
当易损结构为一个时,囊体未膨胀状态下,导丝可精准定位;当易损结构为多个时,即使在囊体膨胀状态下,导丝也易于接触到某一个易损结构。When there is one vulnerable structure, the guide wire can be accurately positioned when the balloon is not inflated; when there are multiple vulnerable structures, the guide wire can easily contact a vulnerable structure even when the balloon is inflated.
囊体游离部上有可供导丝穿越的导丝孔;导丝孔与导丝无间隙接触;导丝孔周边设有加强结构,包括加强筋、上延长段、下延长段中的至少一者。The free part of the capsule has a guide wire hole for the guide wire to pass through; the guide wire hole has no gap contact with the guide wire; a reinforcing structure is provided around the guide wire hole, including at least one of a reinforcing rib, an upper extension section, and a lower extension section. By.
当使用内窥镜连带鞘管在导丝导引下前行或使用囊体膨胀扩张自然腔道后在导丝导引下前行时;导丝孔与穿入其内的导丝为无间隙接触,优选过盈接触,为了确保在囊体游离部膨胀时囊体内腔的流体不会从导丝与导丝孔之间可能出现的间隙泄漏,囊体游离部上导丝孔的周边设有加强结构,包括围绕导丝孔隆起的环形加强筋,与导丝孔连为一体的中空的上延长段、下延长段;当加强结构为上延长段、下延长段时,导丝从延长段内穿过,接触面积更大,更加不易在囊体游离部膨胀时发生流体泄漏,具体使用时即使发生部分流体泄漏也不会严重影响囊体膨胀扩张自然腔道的效果。When using an endoscope with a sheath to advance under guidewire guidance or using a balloon to expand the natural lumen and then advancing under guidewire guidance, there is no gap between the guidewire hole and the guidewire that penetrates it. Contact, preferably interference contact. In order to ensure that the fluid in the inner cavity of the balloon will not leak from the possible gap between the guide wire and the guide wire hole when the free part of the balloon is inflated, the free part of the balloon is provided around the guide wire hole. The reinforcing structure includes an annular reinforcing rib raised around the guide wire hole, and a hollow upper extension section and a lower extension section integrated with the guide wire hole; when the reinforcing structure is an upper extension section and a lower extension section, the guide wire extends from the extension section Through the inner part, the contact area is larger, making it less likely for fluid leakage to occur when the free part of the balloon is inflated. Even if partial fluid leakage occurs during specific use, it will not seriously affect the effect of the balloon's expansion of the natural cavity.
一种细化设计是,为了增加膨胀后的体积,囊体游离部设有向远端乳头状延伸的探出体;或者,囊体游离部设有一个或多个环形皱褶。A refined design is that in order to increase the expanded volume, the free part of the balloon is provided with a protruding body extending toward the distal papilla; or, the free part of the balloon is provided with one or more annular wrinkles.
所述中空的探出体和环形皱褶结构使囊体游离部在内窥镜主体头部顶端投影面积不变的前提下,显著增加了囊体游离部的表面积从而增加囊体内腔膨胀后的体积,有利于在充盈时沿自然腔道轴向延伸膨胀,扩张更多的狭窄腔道;若探出体设计为非中空,非中空的实心探出体易于沿狭窄的自然腔道前行,为随后的囊体扩张起到一定导向作用。The hollow protruding body and annular wrinkle structure significantly increase the surface area of the free part of the capsule while keeping the projected area of the top end of the endoscope body unchanged, thereby increasing the expansion of the inner cavity of the capsule. The volume is conducive to the axial extension and expansion along the natural lumen during filling, and expands more narrow lumens; if the probing body is designed to be non-hollow, the non-hollow solid probing body can easily move forward along the narrow natural lumen, It plays a certain guiding role for subsequent capsule expansion.
为了确保囊体充盈膨胀时不会有流体泄漏,囊体连接部与内窥镜主体头部外表面密封连接,为增加二者间的摩擦力,囊体连接部与内窥镜主体头部外表面优选为过盈配合,这种过盈配合在囊体游离部受到更大外力牵拉时则可脱离;为增加连接的稳定性及为了囊体游离部更易于膨胀,优选的,囊体连接部的壁厚大于囊体游离部。In order to ensure that there will be no fluid leakage when the balloon is inflated, the balloon connecting portion is sealed with the outer surface of the endoscope body head. In order to increase the friction between the two, the balloon connecting portion is sealed with the endoscope body head. The surface is preferably an interference fit. This interference fit can be detached when the free part of the bladder is pulled by a greater external force; in order to increase the stability of the connection and make the free part of the bladder easier to expand, it is preferred that the bladder connection The wall thickness of the part is greater than the free part of the capsule.
一种关键的安全设计是,在囊体游离部与囊体连接部交界处向外延伸出柔性的囊体遮挡部。A key safety design is to extend a flexible bladder shielding portion outward from the junction of the free portion of the bladder and the bladder connection portion.
进一步的,囊体游离部与囊体连接部交界处向外延伸出可包覆鞘管主体内开口外边缘的柔性的囊体遮挡部,柔性的囊体遮挡部设有筒状翻边,筒状翻边包覆鞘管主体内开口外边缘。Further, a flexible bladder shielding portion that can cover the outer edge of the inner opening of the sheath body extends outward from the junction between the free portion of the bladder and the bladder connection portion. The flexible bladder shielding portion is provided with a cylindrical flange. The shaped flange covers the outer edge of the inner opening of the sheath main body.
薄壁的鞘管主体内开口外边缘较为锋利,前行时极易剪切损伤接触到的自然腔道内膜,柔性的囊体遮挡部包覆鞘管主体内开口外边缘,消除了上述的剪切损伤风险,结合囊体游离部扩张式前行的特点,起到双重防护效果。The thin-walled outer edge of the inner opening of the main body of the sheath is relatively sharp, and it is very easy to shear and damage the intima of the natural cavity that it touches when moving forward. The flexible bladder shielding part covers the outer edge of the inner opening of the main body of the sheath, eliminating the above-mentioned problems. The risk of shear injury, combined with the expansion and forward characteristics of the free part of the capsule, has a double protective effect.
一种使用手工即可充盈囊体的方案是,工作通道外开口连有中空的弹性动力囊,挤压弹性动力囊可将其内的流体充盈至囊体内腔,使囊体游离部膨胀;解除挤压后囊体内腔的流体回流至弹性动力囊内腔,囊体游离部形状恢复至膨胀前。A solution that can be used to inflate the bladder manually is to connect a hollow elastic power bladder to the outer opening of the working channel. Squeezing the elastic power bladder can fill the fluid inside the bladder into the inner cavity of the bladder, causing the free part of the bladder to expand; release the After extrusion, the fluid in the inner cavity of the bladder returns to the inner cavity of the elastic power bladder, and the shape of the free part of the bladder body returns to before expansion.
弹性动力囊可反复多次用手指挤压或放松,囊体则同步充盈膨胀或复原,充分利用弹性动力囊自身的复原能力,使用方便,弹性动力囊通过延长段与工作通道外开口连接,弹性动力囊上可设有一连通孔,挤压时手指按住封闭此连通孔,弹性动力囊内气体充盈至囊体内腔,囊体游离部膨胀持续一定时间后放松手指,弹性动力囊自身的回弹加上气体从连通孔流出,使囊体游离部更快的复原;也可外接注射器或其他电子控制的灌注装置及负压吸引装置。The elastic power bag can be squeezed or relaxed with fingers repeatedly, and the bag body will be filled, expanded or restored simultaneously, making full use of the elastic power bag's own recovery ability, which is easy to use. The elastic power bag is connected to the outer opening of the working channel through an extension section, and the elastic power bag is elastic. The power bag can be provided with a communication hole. When squeezing, press and close the communication hole with your fingers. The gas in the elastic power bag will be filled into the inner cavity of the bag. After the free part of the bag expands for a certain period of time, relax your fingers and the elastic power bag will rebound. In addition, the gas flows out from the communication hole, allowing the free part of the capsule to recover faster; it can also be connected to an external syringe or other electronically controlled perfusion device and negative pressure suction device.
为了灵活的操作,鞘管主体邻近鞘管主体内开口处的一段为鞘管主体可弯曲段,和/或内窥镜主体邻近工作通道内开口的一段为内窥镜可弯曲段。For flexible operation, a section of the sheath body adjacent to the opening in the sheath body is a flexible section of the sheath body, and/or a section of the endoscope body adjacent to the opening in the working channel is a flexible section of the endoscope.
可弯曲段使内窥镜在肾盂、肾盏内不容易出现视觉及操作死角。The flexible section makes the endoscope less prone to visual and operational blind spots in the renal pelvis and renal calyces.
一种经输尿管碎石手术系统,还包括灌注装置、碎石光纤、负压吸引装置、压力传感器、温度传感器、结石篮、导丝中的至少一者。A transureteral lithotripsy surgical system also includes at least one of a perfusion device, a lithotripsy optical fiber, a negative pressure suction device, a pressure sensor, a temperature sensor, a stone basket, and a guide wire.
压力传感器、温度传感器可设置在鞘管主体内开口邻近区域,也可设置在内窥镜头部,便于术中对泌尿道内压力及温度的监测,保障手术安全;为了置入及操作时减少摩擦,囊体游离部、内窥镜主体、鞘管主体、导丝中至少一者附有亲水涂层。The pressure sensor and temperature sensor can be installed in the area adjacent to the opening in the sheath body, or in the endoscope lens, to facilitate the monitoring of the pressure and temperature in the urinary tract during the operation and ensure the safety of the operation; in order to reduce friction during insertion and operation, At least one of the free part of the capsule, the endoscope main body, the sheath main body, and the guide wire is provided with a hydrophilic coating.
本发明的有益效果是:The beneficial effects of the present invention are:
1.本装置在自然腔道推进过程中,鞘管主体硬质的头部边缘全程受到柔性囊体遮挡部的保护,显著降低了置镜过程的粘膜剪切损伤。1. During the advancement of this device into the natural orifice, the hard head edge of the sheath body is protected by the flexible capsule shield throughout the entire process, significantly reducing mucosal shear damage during the lens placement process.
2.置镜过程遭遇自然腔道狭窄时,内窥镜主体头部的囊体充盈膨胀,径向扩张狭窄处组织后囊体解除充盈,便于后续通过。2. When the natural orifice is narrowed during the endoscope placement process, the capsule at the head of the endoscope body is filled and expanded. After radially expanding the tissue at the stenosis, the capsule is released to facilitate subsequent passage.
3.内窥镜、鞘管同步推进,减少了操作步骤,提升了效率。3. The endoscope and sheath are advanced simultaneously, which reduces operating steps and improves efficiency.
4.可视化基础上的头部囊体扩张式前行,可省却置镜过程导丝的使用。4. The expansion-type forward movement of the head capsule based on visualization can save the use of guide wires during the lens placement process.
5.压力监测下的头部囊体膨胀扩张自然腔道,扩张效果更为可靠。5. The head capsule expands the natural cavity under pressure monitoring, and the expansion effect is more reliable.
6.置入尿道时内窥镜主体头部囊体可缓慢的径向扩张尿道膜部,保护尿道外括约肌,最大程度避免术后的控尿障碍发生。6. When inserted into the urethra, the endoscope body head capsule can slowly radially expand the urethral membrane, protect the external urethral sphincter, and avoid postoperative urinary control disorders to the greatest extent.
7.柔性扩张输尿管与膀胱连接处,保护瓦尔代尔鞘,最大程度避免术后的膀胱-输尿管返流的发生。7. Flexibly expand the junction between the ureter and the bladder to protect the Valdel sheath and avoid postoperative vesicoureteral reflux to the greatest extent.
显著简化了操作步骤,减少组织损伤,大幅节约手术时间,降低治疗成本。It significantly simplifies the operation steps, reduces tissue damage, greatly saves operation time, and reduces treatment costs.
附图说明Description of the drawings
并不局限本发明的附图如下:The accompanying drawings that do not limit the present invention are as follows:
图1A:现有技术的鞘管、鞘芯、导丝使用示意图;Figure 1A: Schematic diagram of the use of sheath tubes, sheath cores, and guide wires in the prior art;
其中,1A-1:鞘管、鞘芯、导丝组合一起;1A-2:示出硬质内窥镜置入导丝G至肾盂P内;1A-3:鞘芯置入鞘管主体内,沿导丝G上行;Among them, 1A-1: the sheath tube, sheath core, and guide wire are combined together; 1A-2: shows the rigid endoscope inserted into the guide wire G into the renal pelvis P; 1A-3: the sheath core is inserted into the main body of the sheath tube , go up along the guide wire G;
图1B:现有技术内窥镜主体进入鞘管主体示意图;Figure 1B: Schematic diagram of the endoscope body entering the sheath body in the prior art;
其中,1B-1:内窥镜主体进入鞘管主体,内窥镜主体可弯曲头部部分从鞘管主体内开口探出;1B-2:鞘管主体头部位于接近输尿管U肾盂P连接处;1B-3:内窥镜主体可弯曲头部部分探出鞘管主体内开口伸入肾盂P内;Among them, 1B-1: The main body of the endoscope enters the main body of the sheath, and the bendable head part of the main body of the endoscope protrudes from the opening in the main body of the sheath; 1B-2: The head of the main body of the sheath is located close to the ureter U-renal pelvis P connection ; 1B-3: The bendable head portion of the endoscope body extends out of the opening in the sheath body and into the renal pelvis P;
图1C:实施例1内窥镜的示意图,内窥镜主体头部包覆有可膨胀囊体;Figure 1C: Schematic diagram of the endoscope in Embodiment 1. The head of the main body of the endoscope is covered with an inflatable bladder;
图1D:实施例1鞘管示意图,剖视示出鞘管主体尾部的紧固机构T;Figure 1D: Schematic diagram of the sheath tube in Embodiment 1, with a cross-section showing the fastening mechanism T at the tail of the sheath tube body;
图1E:实施例1内窥镜与鞘管结合示意图,局部剖切示出与内窥镜主体头部的囊体相连的弹性动力囊、以及与内窥镜手柄相连的鞘管主体尾部的紧固机构T;Figure 1E: Schematic diagram of the combination of the endoscope and the sheath in Embodiment 1. Partial cross-section shows the elastic power bag connected to the bag at the head of the endoscope body and the tight end of the sheath body connected to the handle of the endoscope. Solid mechanism T;
图1F:实施例1鞘管主体尾部紧固机构T的两个抱合臂T1和紧固旋钮T2分离状态示意图,内窥镜主体尾部14置于其内;Figure 1F: Schematic diagram of the separation state of the two holding arms T1 and the fastening knob T2 of the sheath body tail fastening mechanism T in Embodiment 1, with the endoscope body tail 14 placed inside it;
图1G:实施例1内窥镜主体头部包覆的一种类型的囊体游离部22未膨胀状态的剖视图,囊体游离部设有中空的向远端乳头状延伸的探出体;Figure 1G: A cross-sectional view of a type of free balloon portion 22 covered by the head of the endoscope body in Embodiment 1 in an unexpanded state. The free balloon portion is provided with a hollow protruding body extending toward the distal papilla;
图1H:实施例1囊体游离部22的另一种具有环形皱褶结构特征的剖视图;Figure 1H: Another cross-sectional view of the free part 22 of the balloon body in Embodiment 1 with an annular wrinkle structure;
图1I:实施例1囊体游离部22的另一种向远端乳头状延伸的实心探出体的剖视图;Figure 1I: A cross-sectional view of another solid protruding body extending toward the distal papilla of the free portion 22 of the balloon in Embodiment 1;
图1J:实施例1囊体遮挡部23的剖面示意图;Figure 1J: A schematic cross-sectional view of the capsule shielding part 23 in Embodiment 1;
图1K:实施例1囊体遮挡部23的筒状翻边232剖面示意图;Figure 1K: A schematic cross-sectional view of the cylindrical flange 232 of the capsule shielding part 23 in Embodiment 1;
图1L:实施例1囊体游离部22在输尿管U狭窄处N的剖面示意图;Figure 1L: A schematic cross-sectional view of the free part 22 of the balloon at the stricture N of the ureter U in Embodiment 1;
图1M:实施例1囊体游离部22膨胀状态的剖面示意图,输尿管U狭窄处N被径向扩张;Figure 1M: A schematic cross-sectional view of the expanded state of the free part 22 of the balloon in Embodiment 1, where the stricture N of the ureter U is radially expanded;
图1N:实施例1内窥镜、鞘管一体式推进,局部剖面示出鞘管主体头部位于输尿管U肾盂P交界处,抱合臂T1和紧固旋钮T2分离;Figure 1N: Embodiment 1, the endoscope and the sheath are advanced in one piece. The partial cross-section shows that the head of the sheath body is located at the junction of the ureter, U and renal pelvis, and the holding arm T1 and the fastening knob T2 are separated;
图1O:实施例1内窥镜主体从鞘管主体内腔31向体外退出,局部剖面示出囊体游离部的遮挡部23的反向形变状态;Figure 1O: Embodiment 1 The endoscope body withdraws from the body lumen 31 of the sheath body toward the outside of the body, and the partial cross-section shows the reverse deformation state of the shielding portion 23 of the free part of the balloon;
图2A:实施例2的囊体游离部22易于被导丝G戳破的易损区域220及易损区域上的易损结构221的剖视图;Figure 2A: A cross-sectional view of the vulnerable area 220 of the free part 22 of the balloon that is easily punctured by the guide wire G and the vulnerable structure 221 on the vulnerable area in Embodiment 2;
图2B:实施例2的立体示意图;Figure 2B: A schematic three-dimensional view of Embodiment 2;
图2C:实施例2的导丝G戳破易损结构221的立体示意图;Figure 2C: A schematic three-dimensional view of the guide wire G puncturing the vulnerable structure 221 in Embodiment 2;
图3A:实施例3囊体游离部22上导丝孔222及周边加强筋223的局部剖视图;Figure 3A: A partial cross-sectional view of the guide wire hole 222 and the surrounding reinforcing ribs 223 on the free part 22 of the balloon body in Embodiment 3;
图3B:实施例3囊体游离部22上导丝孔222内穿入导丝G且囊体游离部22处于膨胀状态的局部剖视图;Figure 3B: Embodiment 3 is a partial cross-sectional view of the guidewire G inserted into the guide wire hole 222 on the free part 22 of the balloon and the free part 22 of the balloon is in an expanded state;
图3C:实施例3的一种变通结构,导丝孔222周边设有上延长段224的剖视图;Figure 3C: A modified structure of Embodiment 3, a cross-sectional view of an upper extension section 224 provided around the guide wire hole 222;
图3D:实施例3的一种变通结构,上延长段224随囊体游离部22膨胀前移的剖视图;Figure 3D: A modified structure of Embodiment 3, a cross-sectional view of the upper extension section 224 moving forward as the free part 22 of the balloon expands;
图3E:实施例3的另一种变通结构,局部剖视示出囊体游离部22导丝孔222周边设有下延长段225且囊体遮挡部23具有筒状翻边232。Figure 3E: Another modified structure of Embodiment 3. A partial cross-section shows that the free part 22 of the capsule is provided with a lower extension section 225 around the guide wire hole 222 and the capsule shielding part 23 has a cylindrical flange 232.
具体实施方式Detailed ways
并不局限本发明的实施例如下:Examples that do not limit the present invention are as follows:
实施例1:Example 1:
如图1C所示,一种防护型医用内窥镜装置,可弯曲的细长的内窥镜主体1包括内窥镜主体头部12、内窥镜主体中间部13和内窥镜主体尾部14,内窥镜主体1设有一贯穿头尾的主通道11,主通道11设有使用状态下进入体内的主通道内开口111及使用状态下位于体外的主通道外开口112,内窥镜主体尾部14连有供使用者操作内窥镜的操作手柄15,操作手柄15上设有电源接口151;内窥镜主体1头部顶端121包覆有可膨胀的囊体2,囊体2由囊体连接部21和囊体游离部22构成,囊体连接部21呈筒状与内窥镜主体头部12外表面连接,囊体游离部22为囊体2可膨胀的部分,囊体游离部22与内窥镜主体1头部顶端121之间的间隙形成囊体内腔20;膨胀后的囊体游离部22最大外径至少大于内窥镜主体头部12外径;囊体游离部22为透明状或至少与内窥镜主体1头部顶端121光学组件对应的区域为透明状;囊体内腔20与工作通道11连通;图1G所示,位于内窥镜主体头部12顶端121处的一个镜头10、两个光学窗101;压力、温度二合一传感器102;如图1D,与内窥镜配套的鞘管,使用时细长的鞘管主体3套接在内窥镜主体1外,鞘管主体3包括鞘管主体头部32、鞘管主体中间部33、鞘管主体尾部34,鞘管主体3有使用时进入体内的鞘管主体内开口311及使用时位于体外的鞘管主体外开口312、鞘管主体侧支开口313,鞘管主体侧支上设有调节钮341,当鞘管主体侧支开口313连接负压吸引装置(图略)时,调节钮341用于调控鞘管主体侧支内腔340是否与外部连通;鞘管主体外开口312处设有可与内窥镜主体尾部14紧密连接的紧固机构T,本实施例中紧固机构T由弧形薄片状的抱合臂T1及中空的紧固旋钮T2组成,紧固旋钮T2有一圆形的旋钮外开口T22,抱合臂T1设置为两片,抱合臂T1通过其上的基座T12与鞘管主体尾部34相连,紧固旋钮T2内螺纹T21与抱合臂外螺纹T11配合后,抱合臂T1向轴线L移动,夹紧位于抱合臂内的内窥镜主体尾部14部分(如图1E)使镜鞘可同步推进;图1F示出两个抱合臂T1与紧固旋钮T2分离,抱合臂T1对内窥镜主体尾部14部分的夹紧被解除,此种情况下镜鞘不再紧密结合,内窥镜主体1可在鞘管主体3内自由的前后移动和旋转。As shown in Figure 1C, a protective medical endoscope device, a bendable and slender endoscope body 1 includes an endoscope body head 12, an endoscope body middle part 13 and an endoscope body tail 14 , The endoscope body 1 is provided with a main channel 11 that runs through the head and tail. The main channel 11 is provided with an inner opening 111 of the main channel that enters the body when in use and an outer opening 112 of the main channel located outside the body in use. The tail of the endoscope body 14 is connected to an operating handle 15 for the user to operate the endoscope, and the operating handle 15 is provided with a power interface 151; the top end 121 of the head of the endoscope body 1 is covered with an inflatable capsule 2, and the capsule 2 is composed of a capsule The connecting part 21 is composed of a balloon free part 22. The balloon connecting part 21 is cylindrical and connected to the outer surface of the endoscope body head 12. The balloon free part 22 is an expandable part of the balloon 2. The balloon free part 22 The gap between the top end 121 of the head of the endoscope body 1 forms the inner cavity of the balloon 20; the maximum outer diameter of the expanded free portion of the balloon 22 is at least larger than the outer diameter of the head 12 of the endoscope body; the free portion of the balloon 22 is transparent or at least the area corresponding to the optical component at the top 121 of the head of the endoscope body 1 is transparent; the inner cavity 20 of the capsule is connected to the working channel 11; as shown in Figure 1G, a Lens 10, two optical windows 101; pressure and temperature two-in-one sensor 102; as shown in Figure 1D, a sheath matched with the endoscope. When in use, the slender sheath body 3 is inserted outside the endoscope body 1. The sheath body 3 includes a sheath body head 32, a sheath body middle part 33, and a sheath body tail 34. The sheath body 3 has an internal opening 311 that enters the body during use and a sheath body that is located outside the body during use. The outer opening 312 and the side branch opening 313 of the sheath main body are provided with an adjustment button 341 on the side branch of the sheath main body. When the side branch opening 313 of the sheath main body is connected to a negative pressure suction device (not shown), the adjustment button 341 is used to adjust the sheath. Whether the inner cavity 340 of the side branch of the tube body is connected to the outside; the outer opening 312 of the sheath body is provided with a fastening mechanism T that can be tightly connected to the tail 14 of the endoscope body. In this embodiment, the fastening mechanism T is made of an arc-shaped sheet. It consists of a holding arm T1 and a hollow fastening knob T2. The fastening knob T2 has a circular opening T22 outside the knob. The holding arm T1 is set in two pieces. The holding arm T1 passes through the base T12 on it and the tail 34 of the sheath tube body. Connected, after the internal thread T21 of the fastening knob T2 matches the external thread T11 of the holding arm, the holding arm T1 moves toward the axis L, clamping the tail part 14 of the endoscope body located in the holding arm (as shown in Figure 1E) so that the scope sheath can be synchronized Advance; Figure 1F shows that the two holding arms T1 are separated from the fastening knob T2, and the clamping of the tail 14 part of the endoscope body by the holding arms T1 is released. In this case, the sheath is no longer tightly coupled, and the endoscope body 1 can move forward and backward freely and rotate within the sheath body 3.
为了囊体2更好的膨胀,有以下几种细化方案:如图1G,囊体游离部22设有中空的向远端乳头状延伸的探出体226;如图1H,囊体游离部22上设有多个环形皱褶227;如图1I,囊体游离部22上设有一种向远端乳头状延伸的实心探出体228;为了增加囊体游离部22膨胀后的体积,中空的探出体226和环形皱褶227结构使囊体游离部22在内窥镜主体1头部顶端121区域投影面积不变的前提下,显著增加了囊体游离部22的表面积从而增加膨胀后的囊体内腔体积,有利于囊体游离部22在充盈时沿自然腔道轴向延伸膨胀,扩张更多的狭窄腔道;非中空的实心探出体228也可在膨胀后的囊体前端延伸扩张狭窄腔道且有更强的突破力。In order to better expand the balloon 2, there are several refinement schemes: as shown in Figure 1G, the free part 22 of the balloon is provided with a hollow protruding body 226 extending toward the distal papilla; as shown in Figure 1H, the free part of the balloon 22 is provided with a plurality of annular wrinkles 227; as shown in Figure 1I, the free part 22 of the balloon is provided with a solid protruding body 228 extending toward the distal papilla; in order to increase the volume of the free part 22 of the balloon after expansion, a hollow The structure of the protruding body 226 and annular wrinkles 227 significantly increases the surface area of the free balloon portion 22 while keeping the projected area of the top 121 area of the head of the endoscope body 1 unchanged, thereby increasing the expansion rate after expansion. The volume of the inner cavity of the balloon is conducive to the axial extension and expansion of the free part 22 of the balloon along the natural lumen when it is filled, and expands more narrow lumens; the non-hollow solid protruding body 228 can also be used at the front end of the expanded balloon. Extends and expands narrow channels and has stronger breakthrough power.
如图1E,内窥镜手柄上的工作通道外开口112上相连一中空的弹性动力囊5,弹性动力囊5通过延长部51与手柄15相连,弹性动力囊内腔50可充入气体或液体,弹性动力囊5设有一与外部空间相通的连通孔52;如图1L,当本发明装置镜鞘合一的在输尿管U内推进时,遭遇狭窄处N难以前行时,如图1M,在体外挤压弹性动力囊5可将其内的流体(本例中为空气)充盈至囊体内腔20,使囊体游离部22膨胀,输尿管U的狭窄处N受到柔性的径向扩张,在不剪切损伤粘膜的前提下,消除了狭窄处N对前行的阻碍,利于内窥镜的通过;解除挤压后囊体内腔20的流体回流至弹性动力囊内腔50,囊体游离部22形状恢复至膨胀前;弹性动力囊5可反复多次用手指挤压或放松,囊体2则同步充盈膨胀或复原,充分利用弹性动力囊5自身的复原能力,使用方便;弹性动力囊5上的连通孔52尤其适合气体流通,挤压时手指按住封闭此连通孔52,弹性动力囊5内的气体充盈至囊体内腔20,囊体游离部22膨胀持续一定时间后放松手指,弹性动力囊5自身的复原加上气体从连通孔52流出,使囊体游离部22更快的复原;当然,也可外接注射器或其他电子控制的灌注装置及负压吸引装置操控弹性动力囊5。As shown in Figure 1E, the outer opening 112 of the working channel on the endoscope handle is connected to a hollow elastic power bag 5. The elastic power bag 5 is connected to the handle 15 through an extension 51. The inner cavity 50 of the elastic power bag can be filled with gas or liquid. , the elastic power bag 5 is provided with a communication hole 52 communicating with the external space; as shown in Figure 1L, when the device and the sheath of the present invention are advanced in the ureter U, and it is difficult to move forward when encountering the stenosis N, as shown in Figure 1M, in Squeezing the elastic power balloon 5 outside the body can inflate the fluid (air in this example) into the inner cavity 20 of the balloon, causing the free part 22 of the balloon to expand. The narrow part N of the ureter U is subject to flexible radial expansion. Under the premise of shearing and damaging the mucosa, the obstruction of the forward movement of the stenosis N is eliminated, which facilitates the passage of the endoscope; after the extrusion is released, the fluid in the inner cavity 20 of the balloon returns to the inner cavity 50 of the elastic dynamic bag, and the free part 22 of the balloon body The shape is restored to before expansion; the elastic power bag 5 can be squeezed or relaxed with fingers repeatedly, and the bag body 2 is simultaneously filled, expanded or restored, making full use of the elastic power bag 5's own recovery ability and easy to use; the elastic power bag 5 is on The connecting hole 52 is particularly suitable for gas circulation. When squeezing, press and close the connecting hole 52 with your finger. The gas in the elastic power bag 5 will be filled into the inner cavity 20 of the bag. After the free part 22 of the bag expands for a certain period of time, relax your finger. The recovery of the bladder 5 itself and the outflow of gas from the communication hole 52 allow the free part 22 of the bladder to recover faster; of course, the elastic power bladder 5 can also be controlled by an external syringe or other electronically controlled perfusion device and negative pressure suction device.
因薄壁的鞘管主体3内开口外边缘322较为锋利,前行时极易剪切损伤接触到的腔道内粘膜,为了保护自然腔道粘膜,如图1J,囊体游离部22与囊体连接部21交界处向外延伸出可遮挡鞘管主体3内开口外边缘322的柔性的囊体遮挡部23,本图示出柔性的遮挡部23水平部231将鞘管主体3内开口外边缘322遮挡,封堵了镜鞘间隙130上开口,在输尿管U内推进时不会剪切损伤输尿管U粘膜(图1L);进一步优化方案如图1K所示,柔性的囊体遮挡部23水平部231连有筒状翻边232,筒状翻边232更为彻底的包覆鞘管主体3内开口外边缘322;结合囊体游离部22扩张式前行的特点,起到双重防护效果。Because the outer edge 322 of the inner opening of the thin-walled sheath body 3 is relatively sharp, it is easy to shear and damage the mucosa in the lumen that comes into contact when moving forward. In order to protect the natural lumen mucosa, as shown in Figure 1J, the free part 22 of the balloon body is separated from the balloon body. A flexible bladder shielding part 23 extends outward from the junction of the connecting part 21 and can shield the outer edge 322 of the inner opening of the sheath main body 3. This figure shows that the horizontal part 231 of the flexible shielding part 23 shields the outer edge 322 of the inner opening of the sheath main body 3. 322 block, blocking the upper opening of the scope sheath gap 130, and will not shear and damage the mucosa of the ureter U when advancing in the ureter U (Fig. 1L); the further optimization plan is shown in Fig. 1K, the horizontal part of the flexible bladder blocking part 23 231 is connected with a cylindrical flange 232, and the cylindrical flange 232 more completely covers the outer edge 322 of the inner opening of the sheath body 3; combined with the characteristics of the expansion forward movement of the free part of the capsule 22, it has a double protection effect.
本发明使用时,将内窥镜主体1头部顶端121从鞘管主体内开口311探出,至少将囊体游离部22暴露在外,启动紧固机构T使鞘管主体3与内窥镜主体1紧密连接,实现镜鞘合一的同步进退;当内窥镜主体1在生命体自然腔道内前行遇阻时,可经工作通道外开口112向囊体内腔20充入流体使其膨胀,径向柔性扩张自然腔道狭窄处,便于内窥镜主体1继续在自然腔道内前行;装置到达目标位置后松解紧固机构T,内窥镜主体1可在鞘管主体3内自由旋转或前后移动。When the present invention is used, the top end 121 of the endoscope body 1 is poked out from the inner opening 311 of the sheath body, at least the free part 22 of the balloon is exposed, and the fastening mechanism T is activated to make the sheath body 3 and the endoscope body 1 are tightly connected to realize the synchronous advancement and retreat of the scope and sheath as one; when the endoscope body 1 encounters obstacles in moving forward in the natural cavity of the living body, fluid can be filled into the capsule inner cavity 20 through the outer opening 112 of the working channel to expand it. Radially flexibly expands the narrow part of the natural lumen to facilitate the endoscope body 1 to continue moving forward in the natural lumen; after the device reaches the target position, the fastening mechanism T is loosened, and the endoscope body 1 can freely rotate within the sheath body 3 Or move forward and backward.
本发明中描述的各类管体其位置描述,头部即朝向远端部,使用时进入体内;尾部即朝向近端部,使用时通常位于体外;内开口即远端开口,外开口即近端开口;“前行”为朝向远端方向,“后退”为朝向近端方向。Description of the positions of various types of tube bodies described in the present invention: the head is towards the distal end and enters the body during use; the tail is towards the proximal end and is usually located outside the body during use; the inner opening is the distal opening, and the outer opening is the proximal opening. The end is open; "forward" means toward the distal direction, and "retreating" means toward the proximal direction.
囊体2优选顺应性材料制作,可在柔性径向扩张自然腔道的同时可向前延伸。The balloon body 2 is preferably made of a compliant material and can extend forward while flexibly radially expanding the natural cavity.
使用时,如图1N,本装置镜鞘一体的推进至目标位置后,抱合臂T1与紧固旋钮T2分离,抱合臂T1对内窥镜主体尾部14部分的夹紧被解除,内窥镜主体头部12从鞘管主体内开口311探出至肾盂P内;如图1O,内窥镜主体1从鞘管主体内腔31向后退出,镜鞘间隙130内,囊体游离部22遮挡部23形变后朝上翘起;当内窥镜主体头部12从鞘管主体外开口312退出后,将包覆内窥镜主体头部12的囊体2取下,暴露工作通道11,再将内窥镜主体1置入鞘管主体内腔31,进行随后的碎石或其他医疗操作(图略)。When in use, as shown in Figure 1N, after the device sheath is pushed integrally to the target position, the holding arm T1 is separated from the fastening knob T2, and the clamping of the tail part 14 of the endoscope body by the holding arm T1 is released, and the endoscope body The head 12 protrudes from the inner opening 311 of the sheath body into the renal pelvis P; as shown in Figure 1O, the endoscope body 1 withdraws backward from the inner cavity 31 of the sheath body, and in the scope 130 gap 130, the free part 22 of the capsule blocks the 23 is deformed and tilted upward; when the endoscope body head 12 withdraws from the outer opening 312 of the sheath body, remove the capsule 2 covering the endoscope body head 12 to expose the working channel 11, and then The endoscope body 1 is inserted into the inner cavity 31 of the sheath body to perform subsequent lithotripsy or other medical operations (figure omitted).
囊体连接部21呈筒状与内窥镜主体头部12外表面的连接为易于分离的连接,为了暴露工作通道11,进行随后的其他医疗操作;The connection between the cylindrical balloon connection part 21 and the outer surface of the endoscope body head 12 is an easy-to-separate connection, in order to expose the working channel 11 and perform other subsequent medical operations;
现有技术的内窥镜系统,如图1A、1B所示,其中,中空的鞘管主体3包括鞘管主体头部32、鞘管主体中间部33、鞘管主体尾部34,鞘管主体设有使用时进入体内的鞘管主体内开口311及使用时位于体外的鞘管主体外开口312、鞘管主体侧支开口313,鞘管主体侧支上设有调节钮341,当鞘管主体侧支开口313连接负压吸引装置(图略)时,调节钮341用于调控鞘管主体侧支内腔340是否与外部连通,鞘管主体外开口312内设有中空的弹性密封塞S;鞘芯4包括鞘芯头部42、鞘芯中间部43、鞘芯尾部44,鞘芯内腔41设有鞘芯内开口411、鞘芯外开口412,鞘芯外开口412探出鞘管主体尾部34,鞘芯尾部44末端位于鞘管主体内腔31外,鞘芯尾部44末端设有卡扣体441,卡扣体441与鞘管主体尾部34末端的承接体342卡扣连接,卡扣连接后可鞘管、鞘芯合一的同步进退,鞘芯头部42呈锥形渐细的从鞘管主体内开口311伸出,图中可见鞘管主体3头部顶端321及锋利的鞘管主体3内开口边缘322,导丝G穿越鞘芯内腔41,从鞘芯内开口411探出。The existing endoscopic system is as shown in Figures 1A and 1B, in which the hollow sheath body 3 includes a sheath body head 32, a sheath body middle part 33, and a sheath body tail 34. There are an inner opening 311 of the sheath body that enters the body during use, an outer opening 312 of the sheath body located outside the body during use, and a side branch opening 313 of the sheath body. There is an adjustment button 341 on the side branch of the sheath body. When the side of the sheath body is When the branch opening 313 is connected to a negative pressure suction device (not shown), the adjustment button 341 is used to control whether the side branch lumen 340 of the sheath body is connected to the outside. A hollow elastic sealing plug S is provided in the outer opening 312 of the sheath body; The core 4 includes a sheath core head 42, a sheath core middle part 43, and a sheath core tail 44. The sheath core inner cavity 41 is provided with a sheath core inner opening 411 and a sheath core outer opening 412. The sheath core outer opening 412 pokes out the tail of the sheath tube body. 34. The end of the sheath core tail 44 is located outside the inner cavity 31 of the sheath core body. The end of the sheath core tail 44 is provided with a buckle body 441. The buckle body 441 is buckled with the receiving body 342 at the end of the sheath body tail 34. The buckle connection The sheath and the sheath core can then advance and retreat simultaneously. The head 42 of the sheath core tapers out from the inner opening 311 of the sheath main body. In the figure, the top 321 of the head of the sheath main body 3 and the sharp sheath can be seen. At the inner opening edge 322 of the main body 3, the guide wire G passes through the inner cavity 41 of the sheath core and protrudes from the inner opening 411 of the sheath core.
现有技术的经输尿管肾结石手术置镜的步骤如下:1.如图1A-2,硬质内窥镜头部12由尿道进入膀胱再进入输尿管U;2.沿硬质内窥镜工作通道置入导丝G至肾盂P内;3.退出硬镜仅留导丝在泌尿道内;4.如图1A-3,再经导丝置入输尿管鞘管及其内的鞘芯;5.抽出输尿管导引鞘管内的鞘芯(图略);6.如图1B-1,再将软质内窥镜从输尿管鞘管主体内腔31插入,1B-2示出鞘管主体头部32位于接近输尿管U肾盂P连接处,鞘管主体内开口311朝向肾盂P;1B-3示出内窥镜可弯曲的内窥镜主体头部12部分探出鞘管主体内开口311伸入肾盂P内;开口于软质内窥镜主体头部12的工作通道11承担光纤碎石、冷却冲洗、结石套取等功能,置入软质内窥镜过程操作繁琐。The steps of setting up the endoscope for transureteral nephrolithiasis surgery in the prior art are as follows: 1. As shown in Figure 1A-2, the rigid endoscope lens part 12 enters the bladder from the urethra and then into the ureter U; 2. Place the endoscope along the working channel of the rigid endoscope. Insert the guidewire G into the renal pelvis P; 3. Withdraw the rigid scope, leaving only the guidewire in the urinary tract; 4. As shown in 1A-3, insert the ureteral sheath and the sheath core through the guidewire; 5. Pull out the ureter The sheath core in the guide sheath (picture omitted); 6. As shown in Figure 1B-1, insert the flexible endoscope from the ureteral sheath main body cavity 31. 1B-2 shows that the sheath main body head 32 is located close to At the junction of the ureter U and the renal pelvis P, the inner opening 311 of the sheath body faces the renal pelvis P; 1B-3 shows that the flexible endoscope body head 12 of the endoscope partially extends out of the inner opening 311 of the sheath body and extends into the renal pelvis P; The working channel 11 opened at the head 12 of the main body of the soft endoscope is responsible for the functions of fiber optic lithotripsy, cooling and flushing, stone extraction, etc. The process of inserting the soft endoscope is cumbersome.
本发明的防护型内窥镜装置在自然腔道推进过程中,鞘管主体硬质的头部边缘全程受到柔性遮挡部的保护,显著降低了置镜过程的粘膜剪切损伤;置镜过程遭遇自然腔道狭窄时,内窥镜主体头部囊体充盈膨胀,径向扩张狭窄处后囊体解除充盈,便于后续通过;镜、鞘同步推进,减少了操作步骤,提升了效率,省却了鞘芯4部件也可省却导丝G的使用;可视化基础上的头部囊体扩张式前行;压力监测下的头部囊体膨胀后扩张自然腔道,扩张效果更为可靠;置入尿道时头部囊体可缓慢的径向扩张尿道膜部,保护尿道外括约肌,最大程度避免术后的控尿障碍发生;柔性扩张输尿管与膀胱连接处,保护瓦尔代尔鞘,最大程度避免术后的膀胱-输尿管返流的发生;显著简化了操作步骤,减少组织损伤,大幅节约手术时间,降低治疗成本。During the advancement of the natural orifice of the protective endoscope device of the present invention, the hard head edge of the sheath body is protected by the flexible shielding part throughout the entire process, significantly reducing mucosal shear damage during the lens placement process; When the natural orifice is narrowed, the capsule in the head of the endoscope body is filled and expanded, and the capsule is released after radial expansion of the stenosis to facilitate subsequent passage; the scope and sheath are advanced simultaneously, which reduces operating steps, improves efficiency, and eliminates the need for a sheath The core 4 component can also save the use of guide wire G; the head balloon moves forward based on visualization; the head balloon expands the natural orifice under pressure monitoring, and the expansion effect is more reliable; when inserted into the urethra The head capsule can slowly radially expand the urethral membrane, protect the external urethral sphincter, and avoid postoperative urinary control disorders to the greatest extent; it can flexibly expand the connection between the ureter and the bladder, protect the Valder sheath, and avoid postoperative urinary continence disorders to the greatest extent. The occurrence of vesicoureteral reflux; significantly simplifies the operation steps, reduces tissue damage, greatly saves operation time, and reduces treatment costs.
实施例2:Example 2:
如图2A-2C,本例中,囊体游离部22设有易于被导丝G戳破的易损区域220及位于易损区域220内的易损结构221,为了满足临床使用时个别情况下导丝G穿越囊体游离部22的可能需求,在置入过程中,在不取下囊体2的前提下直接经内窥镜工作通道11穿入导丝G;所述易损区域220为局部薄壁的区域,更容易发生形变和破裂,易损结构221则为各种形状的有导向的局部微小区域的薄壁结构,本例中在易损区域220中央设置十字型更为薄壁的易损结构221,在囊体游离部22充盈膨胀时不易破损,而受到细径的导丝G穿刺时易于破裂,但破裂后对导丝G仍会抱紧,试验表明,导丝G穿透易损结构221后囊体游离部22仍可多次充盈膨胀,即使会有少量流体泄漏但不影响囊体游离部22对自然腔道的扩张。As shown in Figures 2A-2C, in this example, the free part 22 of the capsule is provided with a vulnerable area 220 that is easily punctured by the guide wire G and a vulnerable structure 221 located in the vulnerable area 220. In order to meet the needs of individual cases during clinical use There may be a need for the guide wire G to pass through the free part 22 of the balloon. During the insertion process, the guide wire G must be directly inserted through the endoscope working channel 11 without removing the balloon 2; the vulnerable area 220 is Local thin-walled areas are more prone to deformation and rupture. The vulnerable structure 221 is a thin-walled structure with guided local micro-areas in various shapes. In this example, a cross-shaped structure is set in the center of the vulnerable area 220 to make it thinner. The fragile structure 221 is not easily damaged when the free part of the balloon 22 is inflated, but is easy to rupture when punctured by the thin-diameter guide wire G. However, the guide wire G will still hold tightly after the rupture. Tests have shown that the guide wire G is not easily damaged when the guide wire G is punctured. After the fragile structure 221 is transparent, the free part 22 of the balloon can still be filled and expanded multiple times. Even if there is a small amount of fluid leakage, it will not affect the expansion of the natural cavity by the free part 22 of the balloon.
实施例3:Example 3:
如图3A-3E,本实施例与实施例2不同的是,在囊体游离部22上预设导丝孔222,并在导丝孔222周边设置加强结构,导丝G穿过时仍能很好的密封,即流体难以从导丝G与导丝孔222之间逃逸泄漏;图3A示出在导丝孔222周边的环形厚壁加强筋223,加强筋223内的导丝孔222外径小于或等于穿过导丝孔222部分的导丝G外径;同时,囊体连接部21的壁厚大于囊体游离部22,为了确保囊体2充盈膨胀时不会有流体从囊体连接部21泄漏,囊体连接部21与内窥镜主体头部12外表面密封连接,囊体连接部21的壁厚大于囊体游离部22,且囊体连接部21与内窥镜主体头部12外表面优选为过盈配合,即装配后的囊体连接部21在镜鞘间隙130内向外侧微微形变,虽是过盈配合但囊体2弹性材料的特点可使囊体游离部22受到更大外力牵拉时连带囊体连接部21发生形变从而从内窥镜主体头部12脱离;图3B示出囊体游离部22在膨胀状态下,导丝孔222抱紧其内的导丝G,而环形加强筋223则强化了这种抱紧力,囊体内腔20的气体或液体不易从导丝孔222与导丝G之间泄漏,本图中示出锋利的鞘管主体3内开口外边缘322触及输尿管U粘膜,在前行时极易发生剪切损伤。As shown in Figures 3A-3E, the difference between this embodiment and Embodiment 2 is that a guide wire hole 222 is preset on the free part 22 of the balloon, and a reinforcing structure is provided around the guide wire hole 222, so that the guide wire G can still easily pass through it. A good seal means that it is difficult for fluid to escape and leak from between the guide wire G and the guide wire hole 222; Figure 3A shows an annular thick-walled reinforcing rib 223 around the guide wire hole 222, and the outer diameter of the guide wire hole 222 within the reinforcing rib 223. Less than or equal to the outer diameter of the guide wire G passing through the guide wire hole 222; at the same time, the wall thickness of the balloon connection part 21 is larger than the balloon free part 22, in order to ensure that no fluid will be connected from the balloon when the balloon 2 is inflated. part 21 leaks, the balloon connection part 21 is sealed with the outer surface of the endoscope body head 12, the wall thickness of the balloon connection part 21 is larger than the balloon free part 22, and the balloon connection part 21 is connected with the endoscope body head 12 12 The outer surface is preferably an interference fit, that is, the assembled capsule connection part 21 deforms slightly outward in the lens sheath gap 130. Although it is an interference fit, the characteristics of the elastic material of the capsule 2 can cause the free part 22 of the capsule to be When a large external force is pulled, the balloon connecting portion 21 deforms and detaches from the endoscope body head 12; Figure 3B shows that the balloon free portion 22 is in an expanded state, and the guide wire hole 222 tightly embraces the guide wire G inside it. , and the annular reinforcing ribs 223 strengthen this holding force, so that the gas or liquid in the inner cavity of the balloon 20 is not easy to leak from between the guide wire hole 222 and the guide wire G. This figure shows the sharp inner opening of the sheath body 3 The outer edge 322 touches the mucosa of the ureter U and is prone to shear injury when moving forward.
另一种导丝孔222的加强结构如图3C,导丝孔222连有管状的上延长段224,上延长段224可以设置为内径不等结构,即上开口或下开口略大,下开口大可为导丝G从下开口穿入时做导向;图3D示出囊体游离部22膨胀状态,上延长段224包裹导丝G,囊体内腔20的流体部不泄漏或仅微量泄漏。Another reinforced structure of the guide wire hole 222 is shown in Figure 3C. The guide wire hole 222 is connected to a tubular upper extension section 224. The upper extension section 224 can be configured with a structure with unequal inner diameters, that is, the upper opening or the lower opening is slightly larger, and the lower opening is slightly larger. It can be used as a guide when the guide wire G penetrates through the lower opening; Figure 3D shows the expansion state of the free part 22 of the balloon, the upper extension section 224 wraps the guide wire G, and the fluid part of the balloon inner cavity 20 does not leak or only leaks slightly.
图3E示出又一种导丝孔222加强结构,导丝孔222连有管状的下延长段225,同时囊体遮挡部23具有柔软的筒状翻边232,更好的保护自然腔道粘膜。Figure 3E shows another reinforced structure of the guide wire hole 222. The guide wire hole 222 is connected with a tubular lower extension section 225. At the same time, the capsule shielding part 23 has a soft cylindrical flange 232 to better protect the natural orifice mucosa. .
与导丝孔222连为一体的中空的上延长段224、下延长段225,导丝从延长段内穿过时,接触面积更大,不易在囊体游离部22膨胀时发生流体泄漏,试验表明,具体使用时即使发生部分微量泄漏也不会严重影响囊体膨胀扩张自然腔道的效果。The hollow upper extension section 224 and the lower extension section 225 are integrated with the guide wire hole 222. When the guide wire passes through the extension section, the contact area is larger, making it less likely for fluid leakage to occur when the free part 22 of the balloon expands. Tests have shown that , even if some trace leakage occurs during specific use, it will not seriously affect the effect of balloon expansion and expansion of the natural cavity.
为能清晰显示关键结构,本发明附图中未示出囊体游离部22膨胀后的壁厚减小的变化。In order to clearly display key structures, the reduction in wall thickness of the free part 22 of the balloon after expansion is not shown in the drawings of the present invention.
本发明用于肾结石手术时,鞘管主体3邻近鞘管主体内开口311处的一段为鞘管主体可弯曲段,和/或内窥镜主体邻近工作通道内开口111的一段为内窥镜可弯曲段;内窥镜可弯曲段使内窥镜主体头部在肾盂、肾盏内不容易出现视觉及操作死角。When the present invention is used for kidney stone surgery, the section of the sheath body 3 adjacent to the inner opening 311 of the sheath body is the flexible section of the sheath body, and/or the section of the endoscope body adjacent to the inner opening 111 of the working channel is the endoscope. Flexible section: The flexible section of the endoscope prevents visual and operational blind spots in the renal pelvis and calyces of the main body of the endoscope.
本发明用于经输尿管碎石手术系统时,还包括灌注装置(图略)、碎石光纤(图略)、负压吸引装置(图略)、压力传感器、温度传感器(图略)、结石篮(图略)、导丝中的至少一者;压力传感器、温度传感器可设置在鞘管主体内开口311邻近区域,也可设置在内窥镜主体头部12区域,便于术中对泌尿道内压力及温度的监测,保障手术安全;为了置入及操作时减少摩擦,囊体游离部22、内窥镜主体1、鞘管主体3、导丝G附有亲水涂层。When used in a transureteral lithotripsy surgical system, the present invention also includes a perfusion device (not shown), an optical fiber for lithotripsy (not shown), a negative pressure suction device (not shown), a pressure sensor, a temperature sensor (not shown), and a stone basket. (Figure omitted), at least one of the guide wire; the pressure sensor and the temperature sensor can be arranged in the area adjacent to the opening 311 in the sheath body, or can also be arranged in the head 12 area of the endoscope body to facilitate monitoring of the pressure in the urinary tract during the operation. and temperature monitoring to ensure surgical safety; in order to reduce friction during insertion and operation, the free part of the capsule 22, the endoscope body 1, the sheath body 3, and the guide wire G are equipped with hydrophilic coatings.
本发明的防护型医用内窥镜,显著简化了操作步骤,降低组织损伤,节约手术时间,降低治疗成本;可用于在包括心血管以及呼吸道、耳道、泪道、生殖道、消化道在内的各类自然腔道内或生命体胸腔、腹腔等第三间隙内的医疗操作,也可用于贯通伤的伤道、病理窦道等的医疗操作。The protective medical endoscope of the present invention significantly simplifies the operating steps, reduces tissue damage, saves operation time, and reduces treatment costs; it can be used in cardiovascular and respiratory tracts, ear canals, tear ducts, reproductive tracts, and digestive tracts. It can be used for medical operations in various natural cavities or third spaces such as the thorax and abdominal cavity of living bodies. It can also be used for medical operations on penetrating injury tracts, pathological sinus tracts, etc.
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