WO2016008294A1 - 异形球囊式输尿管结石阻挡取出器 - Google Patents

异形球囊式输尿管结石阻挡取出器 Download PDF

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Publication number
WO2016008294A1
WO2016008294A1 PCT/CN2015/071190 CN2015071190W WO2016008294A1 WO 2016008294 A1 WO2016008294 A1 WO 2016008294A1 CN 2015071190 W CN2015071190 W CN 2015071190W WO 2016008294 A1 WO2016008294 A1 WO 2016008294A1
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Prior art keywords
balloon
stone
operating rod
ureteral
ureteral stone
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PCT/CN2015/071190
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English (en)
French (fr)
Inventor
孙颖浩
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中国人民解放军第二军医大学
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Application filed by 中国人民解放军第二军医大学 filed Critical 中国人民解放军第二军医大学
Priority to EP15822245.5A priority Critical patent/EP3143952B1/en
Priority to US15/319,373 priority patent/US20170128091A1/en
Priority to JP2017517165A priority patent/JP2017517369A/ja
Publication of WO2016008294A1 publication Critical patent/WO2016008294A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B17/22032—Gripping instruments, e.g. forceps, for removing or smashing calculi having inflatable gripping elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B2017/22035—Gripping instruments, e.g. forceps, for removing or smashing calculi for retrieving or repositioning foreign objects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22067—Blocking; Occlusion

Definitions

  • the present invention relates to the field of medical devices, and in particular to a shaped balloon ureteral stone obstruction extractor.
  • Blocking the ureteral calculi with tools is an important means to prevent ureteral stones from being recoiled back to the kidneys.
  • ureteral occlusion devices in clinical practice. Usually, such stone blocking tools also have the function of removing stones. However, these ureteral occlusion devices still have certain disadvantages in practical use.
  • the stone basket is the most commonly used stone intercepting and removing tool. It is stretched into a mesh shape after crossing the stone to prevent the stone debris from drifting upward. At the same time, the stone basket is used as a stone removing tool to make small stones. The debris is caught and removed.
  • the set of stone baskets is large in size and inconvenient to place. It may also push the stones to shift during the placement process. Moreover, the amount of stone taken each time in the set of stone baskets is limited, and it is often necessary to enter the mirror multiple times.
  • the set of stone baskets can not completely seal the ureteral lumen, there is still the probability of stone leakage; in addition, the stone ridges in the stone basket are easy to squeeze out of the basket hole, drag It is easy to scratch the ureteral wall when removing stones, and serious complications are caused.
  • occlusion is to completely seal the ureteral lumen as much as possible through the diaphragm or balloon.
  • the Chinese patent document CN 200910057068.2 published on 2009.10.14, discloses a occlusion device for blocking an obstacle in a body cavity, the occlusion device comprising a guide wire, a catheter, and a stopper, the guide One end of the wire passes through the catheter and the closure cavity, the distal end of the closure is fixed to the guide wire, the proximal end of the guide wire is pulled, and the deployed closure is axially compressed to form a plug-like closure.
  • the closure is a flat membrane-like closure.
  • the blocking device prevents the stones from moving up by forming a plug-like plugging device, and can use the blocking device to drag a plurality of stone fragments to the bladder at the same time after the crushing stone.
  • it does not completely block the ureteral lumen, especially during the process of dragging the stone, the device shape is easily changed by water injection in the endoscope working channel, causing the stone to slip off between the device and the ureter wall, or Due to the large number of stones, the stones and the occlusion device are embedded in the ureter, and there is a risk of damaging the ureter mucosa.
  • the existing membranous occluder or balloon tends to be bulky, and is not as convenient as a set of stone baskets during placement, and it is easier to push the stone back to the kidney.
  • the object of the present invention is to provide a shaped balloon ureteral stone obstruction extractor for the deficiencies in the prior art.
  • the utility model relates to a shaped balloon ureteral stone obstruction extracting device, which is provided with a proximal opening, a distal closed and hollow operating lever, a distal end section of the operating rod is provided with a fitting groove, and the fitting groove is provided with a ring shape.
  • the balloon is provided with a sealing membrane on the outer periphery of the balloon, and the inside of the balloon is in communication with the cavity of the operating rod.
  • the fitting groove surrounds the operating rod for one week
  • the balloon surrounds the fitting groove for one week
  • the plane of the balloon is perpendicular to the operating rod.
  • the sealing film surrounds the outer circumference of the balloon at least one turn.
  • the occlusive membrane is a single membrane or consists of a plurality of valves.
  • the occlusion membrane is composed of a plurality of valves, and the valves are arranged in an overlapping manner and surround the balloon several times.
  • the lower edge of the occlusive membrane is inclined toward the proximal end of the operating rod.
  • the sealing membrane is fixed on the outer circumference of the balloon having the largest diameter.
  • a through hole is formed in a portion where the operating rod is connected to the balloon.
  • the through holes are arranged around the operating rod.
  • the top end of the distal end section of the operating rod is provided with a guiding head having a curved surface.
  • the outer periphery of the balloon is provided with a sealing film. Since the sealing film is not easy to be incarcerated with the stone, the diameter of the entire sealing device composed of the balloon and the sealing film can be designed to be slightly larger than the diameter of the ureter. It can achieve the purpose of completely blocking, preventing stone slippage and missing, and taking stone at one time, and can reduce the incidence of stone incarceration.
  • the balloon and the sealing film are all plastic film, which can be shrunk into a small volume, and the operating rod is provided with a fitting groove, and the balloon and the sealing film can be accommodated in the fitting groove, which is convenient.
  • the placement of the ureteral stone obstruction extractor of the present invention does not push the stone back to the kidney and does not easily damage the ureteral wall.
  • the lower edge of the sealing film is designed to be inclined toward the proximal end of the operating rod, so that a space can be formed with the balloon to accommodate part of the gravel to reduce the friction between the gravel and the ureter wall;
  • the tip direction is inclined and the sealing film is placed on the outer circumference line with the largest balloon diameter to ensure the sealing film under the impact force of the endoscope working channel water flow. It can always be in an abduction state and is not easily deformed.
  • Figure 1 is a schematic view showing the structure of a shaped balloon ureteral stone obstruction extractor of the present invention.
  • Figure 2 is an enlarged view of A in Figure 1.
  • Figure 3 is a cross-sectional view taken along line B-B of Figure 2;
  • FIG. 1 is a schematic structural view of a shaped balloon ureteral stone obstruction extractor of the present invention.
  • the ureteral stone obstructing and extracting device is provided with an operating rod 1, and the operating rod 1 is a cylindrical hollow tubular body, which is open at the proximal end and closed at the distal end.
  • a handle 2 is provided on the outer circumference of the proximal end section 11 of the operating lever.
  • the top end of the distal end section 12 of the operating lever is provided with a guide head 3 which is hemispherical.
  • FIG. 2 is an enlarged view of A in FIG. 1.
  • the lever distal section 12 is provided with a fitting groove 4 at a position behind the guide head 3, and the fitting groove 4 surrounds the operating lever 1 once.
  • the fitting groove 4 is provided with an annular balloon 5 which is surrounded by the fitting groove 4, and the plane of the balloon 5 is perpendicular to the operating rod 1.
  • the outer periphery of the balloon 5 is provided with a sealing membrane 6, and the sealing membrane 6 is a single membrane, which surrounds the balloon 5 for one week.
  • FIG. 3 is a cross-sectional view taken along line B-B of FIG. 2.
  • the occluding membrane 6 is fixed to the outer peripheral line of the balloon 5 having the largest diameter, and the lower edge of the occluding membrane 6 is inclined toward the proximal end of the operating rod 1.
  • the portion of the operating rod 1 that is connected to the balloon 5 is provided with a through hole 7, and the through hole 7 is provided with a plurality of holes 7 arranged around the operating rod 1.
  • the balloon 5 When the ureteral stone obstruction extractor of the present invention is in an unused state, that is, at the time of shipment, the balloon 5 is in a deflated state, and the balloon 5 and the occlusion membrane 6 are both crimped and attached in the fitting groove 4. Making the diameter at the fitting groove 4 not larger than The diameter of the operating lever 1.
  • proximal refers to the end of the procedure that is closer to the surgeon
  • distal refers to the end that is further away from the surgeon during the procedure.
  • the lever proximal section 11 refers to a section near the proximal end
  • the lever distal section 12 refers to a section near the proximal end, the specific length of which is variable, the distal end of the lever
  • the section 12 is intended to accommodate at least the guide head 3 and the fitting groove 4.
  • the balloon 5 is used for sealing stones, which are closed and strong plugs, and are not easily deformed under the impact of water flow.
  • the sealing membrane 6 is used to further block a gap that may be formed between the balloon 5 and the ureter wall, and since the sealing membrane 6 itself does not generate a large friction force on the ureter wall, the balloon and the balloon can be
  • the diameter of the entire occlusion device formed by the occlusive membrane is designed to be slightly larger than the diameter of the ureter, preferably 10-35 mm, to achieve complete sealing, effective prevention of stone slippage and disposable stone removal, and, in addition, due to the occlusion membrane 6 and the ureter
  • the contact surface of the wall is small, so the chance of the stone being invaded in the ureter can be greatly reduced.
  • the occluding membrane 6 is not limited to being designed to surround the balloon 5, and may be designed to surround the balloon 5 for several weeks; the occluding membrane 6 may be a complete single membrane or may be composed of a plurality of valves.
  • a plurality of fan-shaped valves are arranged in a staggered or overlapping manner to surround the balloon a plurality of rings; the structural forms of the above various sealing films 6 can completely block the ureter, and it is not easy to reduce the incidence of stone incarceration. And provide space for the gravel to accommodate, reducing damage to the ureteral wall.
  • the sealing film 6 is preferably designed on the outer circumference of the balloon 5 having the largest diameter, and the lower edge of the sealing film 6 is inclined toward the proximal end of the operating rod 1, so that the entire sealing can be realized, and the missing stone is most unlikely to occur. And incarceration, and under the impact of the flow of the endoscope working channel, the sealing film can always be in an abducted state, and is not easily deformed.
  • the guiding head 3, the balloon 5, and the sealing film 6 may be separate components, and then welded, bonded or otherwise fixed to the operating rod 1, or may be integrally formed with the operating rod 1.
  • the balloon 5 and the sealing film 6 can be made of PU, TPU, Pebax, FEP, ETFE, TPFE, etc., and the material is small in volume, but has good toughness and shaping ability.
  • the fitting groove 4 is used for accommodating the balloon 5 and the occluding membrane 6 in a deflated state, so that the overall diameter of the ureteral stone obstructing and extracting device of the present invention is small, and when placed, it is easy to bypass the stone, which is not easy. Causes stone displacement and does not damage the ureteral wall.
  • the fitting groove 4 is not limited to being provided to surround the operation lever 1 for one week, and a plurality of strip-shaped fitting grooves may be spaced around the operation lever 1 or the like.
  • the hollow chamber of the operating rod 1 is used to inject air or water from the proximal end, and then expands the balloon 5 through the through hole 7.
  • the through hole 7 is used to communicate the inside of the balloon 5 and the cavity of the operating rod 1. It is not limited to a circular hole, but may be other shapes such as a square. The arrangement of the through holes 7 is not limited at all.
  • the guiding head 3 is preferably designed to be hemispherical or other curved shape, and does not damage the ureter wall when guiding the ureteral stone of the present invention to block the extractor from entering the ureter.
  • the operating rod 1 has a proximal end for connecting the syringe, and a normally closed one-way air valve at the proximal end thereof for closing the cavity of the operating rod 1 to maintain the inflated state of the balloon 5.
  • the ureteral stone obstruction extractor of the present invention is used as follows: when ureteroscope lithotripsy is used, an endoscope is formed The working channel is placed in the endoscope, and the factory package of the ureteral stone obstruction extractor of the present invention is disassembled.
  • the hand grip 2 enters the guiding end of the operating rod 1 into the ureter, bypasses the stone and reaches above the stone, and then passes the operating rod.
  • the proximal end of 1 inflates or injects water into the cavity of the operating rod 1, at which time air or water flows through the passage 7 into the cavity of the balloon 5, the balloon 5 expands into a ring shape, and the sealing film 6 is supported and formed.
  • the ureteral stone obstruction extractor of the invention has small volume, is easy to be placed into the ureter, does not push the stone to retrograde to the kidney and causes damage to the ureteral wall, and can completely block the ureter, thereby effectively preventing stones and stone fragments from being returned to the kidney by the perfusion water flow. It is not easy to occur in the case of stone incarceration. It is not easy to deform and rub the ureteral wall during the process of removing the stone. It can take out all the stones at one time and achieve the purpose of efficient stone discharge.
  • the ureteral stone obstruction extractor of the present invention can be used not only for the sealing and removal of ureteral stones, but also for the sealing of other body cavities and foreign body removal, including but not limited to the following applications: for blocking and shifting of kidney stones
  • the vascular thrombus is blocked and removed, the vascular puncture hole is blocked to stop bleeding, and the body cavity foreign body is blocked and removed, such as the treatment of foreign bodies in the trachea and intestine.

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Abstract

一种异形球囊式输尿管结石阻挡取出器，其设有近端开口、远端封闭且中空的操作杆（1），操作杆（1）远端区段设有嵌合槽（4），所述嵌合槽（4）上设有环状的球囊（5），所述的球囊（5）外周设有封堵膜（6），所述的封堵膜（6）环绕球囊的外周至少一圈，球囊的内部与操作杆的腔体连通。该输尿管结石阻挡取出器体积小，易于置入输尿管，不会推动结石向肾脏逆行和造成输尿管壁损伤，且能完全封堵输尿管，有效防止结石及结石碎片被灌注水流冲回肾内，不易发生结石嵌顿，托移取石过程不易变形和摩擦输尿管壁，能一次性取出全部结石，达到高效排石的目的。

Description

异形球囊式输尿管结石阻挡取出器 技术领域
本发明涉及医疗器械领域，具体地说，涉及一种异形球囊式输尿管结石阻挡取出器。
背景技术
泌尿系结石发病率高达5％-10％，可见于肾、膀胱、输尿管和尿道的任何部位，以肾与输尿管结石为常见。输尿管镜碎石术经过人体自然腔道进行碎石，具有微创和碎石确切的优点，是目前输尿管结石的主要治疗手段之一。然而，目前输尿管镜碎石术也存在一定不足：1.输尿管中、上段结石及结石碎片容易被灌注水流或碎石工具的反冲力冲回肾内；2.输尿管管腔内的残留结石碎屑缺乏快捷有效地方式取出。
通过工具封阻输尿管结石上方是防止输尿管结石被反冲回肾脏的重要手段，目前临床上也有一些输尿管封堵器，通常情况下此类结石阻截工具还兼具取出结石的功能。然而这些输尿管封堵器在实际使用中仍存在一定的缺点。
套石篮是目前最常用的结石阻截取出工具，其在跨越结石的上方后撑开成网状从而起到防止结石碎屑向上漂移的作用，同时，套石篮作为取石工具，将小的结石碎屑网住并取出。但是套石篮体积较大，不便于放置，在放置过程中还可能推动结石使其移位；而且套石篮每次取石的量有限，往往需要多次进镜，而反复注水进镜则会增加残留碎屑漂移的风险；另外，套石篮并不能将输尿管管腔完全封住，仍存在结石漏网的机率；再者，套石篮中的结石凸棱容易从篮孔中挤出，拖移取石时容易划伤输尿管壁，严重者引起并发症。
另一种封阻方式则是通过膜片或球囊将输尿管管腔尽可能地完全封住。例如中国专利文献CN 200910057068.2，公开日2009.10.14，公开了一种封堵体腔中障碍物的封堵装置，所述的封堵装置包括一导丝、一导管、一封堵物，所述导丝一端穿过导管及封堵物腔体，所述封堵物远端与导丝固定，牵拉导丝近端，展开的封堵物被轴向压缩，形成栓状封堵物，所述封堵物为扁平的膜状封堵物。该封阻装置通过形成栓状封堵物防止结石上移，并在碎石术后可利用封阻装置将多个结石碎屑同时拖至膀胱。然而，其并不能将输尿管管腔完全封堵，特别是在拖移结石的过程中，装置形态容易因内窥镜工作通道内注水而发生改变，造成结石从装置和输尿管壁之间滑脱，或由于碎石数量大而使得结石与该封阻器嵌顿在输尿管内，存在损伤输尿管粘膜的风险。另外，现有的膜状封阻器或球囊往往体积偏大，在放置过程中不如套石篮方便，更容易将结石顶回肾脏。
综上所述，亟需一种放置方便、不易造成结石移位，移除碎石时不易变形、封堵完全、不易发生结石嵌顿而损伤输尿管壁，且取石便捷的输尿管结石阻挡取出器，但是目前关于此类装置还未见报道。
发明内容
本发明的目的是针对现有技术中的不足，提供一种异形球囊式输尿管结石阻挡取出器。
为实现上述目的，本发明采取的技术方案是：
一种异形球囊式输尿管结石阻挡取出器，设有近端开口、远端封闭且中空的操作杆，操作杆远端区段设有嵌合槽，所述的嵌合槽上设有环状的球囊，所述的球囊外周设有封堵膜，且球囊的内部与操作杆的腔体连通。
所述的嵌合槽环绕操作杆一周，所述的球囊环绕嵌合槽一周，且球囊所在的平面与操作杆垂直。
所述的封堵膜环绕球囊的外周至少一圈。
所述的封堵膜为单张膜，或者由多个瓣膜组成。
所述的封堵膜由多个瓣膜组成，所述的瓣膜重叠排列，环绕球囊若干圈。
所述的封堵膜的下缘向操作杆的近端倾斜。
所述的封堵膜固定在球囊直径最大的外周线上。
所述操作杆与球囊连接的部位设有通孔。
所述的通孔环绕操作杆排布。
所述的操作杆远端区段的顶端设有表面为曲面的导向头。
本发明优点在于：
1、球囊外周设有封堵膜，由于封堵膜不易和结石发生嵌顿，因此可将球囊和封堵膜所构成的整个封堵装置的直径设计得稍大于输尿管直径，如此既能达到封堵完全、防止结石滑脱遗漏、一次性取石的目的，又能降低结石嵌顿的发生率。
2、所述的球囊、封堵膜均为塑料材质薄膜，能收缩成很小体积，且操作杆上设有嵌合槽，球囊、封堵膜均能容纳在嵌合槽内，便于本发明输尿管结石阻挡取出器的置入，不会推动结石逆行回肾脏，也不易损伤输尿管壁。
3、所述的封堵膜下缘设计成向操作杆近端方向倾斜，如此可与球囊形成一个空间，容纳部分碎石，减少碎石与输尿管壁的摩擦；通过下缘向操作杆近端方向倾斜以及将封堵膜设在球囊直径最大的外周线上，可保证在内窥镜工作通道水流的冲击力下，封堵膜 始终能处于外展状态，不易变形。
4、设有导向头，置入时不会损伤输尿管壁。
附图说明
附图1是本发明的异形球囊式输尿管结石阻挡取出器的结构示意图。
附图2是图1中A的放大图。
附图3是图2的B-B剖视图。
具体实施方式
下面结合附图对本发明提供的具体实施方式作详细说明。
附图中涉及的附图标记和组成部分如下所示：
1.操作杆              11.操作杆近端区段
12.操作杆远端区段     2.手柄
3.导向头              4.嵌合槽
5.球囊                6.封堵膜
7.通孔
实施例1
请参照图1，图1是本发明的异形球囊式输尿管结石阻挡取出器的结构示意图。所述的输尿管结石阻挡取出器设有操作杆1，所述的操作杆1为圆柱形中空管体，近端开口，远端封闭。操作杆近端区段11的外周设有手柄2。操作杆远端区段12的顶端设有导向头3，所述的导向头3为半球形。
请参照图2，图2是图1中A的放大图。所述的操作杆远端区段12在导向头3后方的位置设有嵌合槽4，所述的嵌合槽4环绕操作杆1一周。嵌合槽4上设有环状的球囊5，所述的球囊5环绕嵌合槽4一周，且球囊5所在的平面与操作杆1垂直。所述的球囊5外周设有封堵膜6，所述的封堵膜6为单张膜，环绕球囊5一周。
请参照图3，图3是图2的B-B剖视图。所述的封堵膜6固定在球囊5直径最大的外周线上，且封堵膜6的下缘向操作杆1的近端倾斜。所述的操作杆1与球囊5连接的部位设有通孔7，所述的通孔7设有若干个，环绕操作杆1排布。
需要说明的是：
本发明的输尿管结石阻挡取出器在未使用状态下，也即出厂时，所述的球囊5处于放气状态，球囊5和封堵膜6均皱缩贴附在嵌合槽4内，使得嵌合槽4处的直径不大于 操作杆1的直径。
本文中，所述的“近端”是指手术过程中距离术者较近的一端，所述的“远端”是指手术过程中距离术者较远的一端。所述的操作杆近端区段11是指靠近近端的一个区段，所述的操作杆远端区段12是指靠近近端的一个区段，其具体长度均不定，操作杆远端区段12以至少能够容纳导向头3和嵌合槽4的为准。
所述的球囊5用于封堵结石，其为密闭且牢固的封堵物，不易在水流的冲击下变形。所述的封堵膜6用于进一步封堵球囊5与输尿管壁之间可能形成的缝隙，且由于封堵膜6本身不会对输尿管壁产生较大的摩擦力，因此可以将球囊和封堵膜所构成的整个封堵装置的直径设计得稍大于输尿管直径，优选为10-35mm，达到封堵完全、有效防止结石滑脱和一次性取石的目的，另外，由于封堵膜6与输尿管壁的接触面是很小的，因此还可以大大降低碎石嵌顿在输尿管的几率。所述的封堵膜6不仅限于设计成环绕球囊5一周，还可设计成环绕球囊5数周；所述的封堵膜6可以是完整的单张膜，也可以由多个瓣膜组成，例如，由多个扇形的瓣膜交错或重叠排列，环绕球囊若干圈；以上各种封堵膜6的结构形式均可实现对输尿管的完全封堵，且不易降低结石嵌顿的发生率，并提供给碎石以容纳的空间，减少对输尿管壁的损伤。所述的封堵膜6优选设计在球囊5直径最大的外周线上，且封堵膜6的下缘向操作杆1的近端倾斜，如此可实现全面封堵，最不易发生碎石遗漏和嵌顿，并能在内窥镜工作通道水流的冲击力下，保持封堵膜始终能处于外展状态，不易变形。所述的导向头3、球囊5、封堵膜6可以是独立的部件，然后焊接、粘接或以其它方式固定在操作杆1上，也可以和操作杆1一体成型。所述的球囊5、封堵膜6可选用PU、TPU、Pebax、FEP、ETFE、TPFE等材质，该材质体积小，但是有很好的韧性和塑形能力。所述的嵌合槽4用于容纳放气状态下的球囊5和封堵膜6，使得本发明的输尿管结石阻挡取出器整体直径较小，置入时，很容易能绕开结石，不易造成结石移位，亦不会损伤输尿管壁。所述的嵌合槽4不仅限于设置成环绕操作杆1一周，也可以是多个条形嵌合槽环绕操作杆1间隔排列等。所述的操作杆1中空的腔体用于从近端注入空气或水流，再经过通孔7使球囊5膨胀。所述的通孔7用于连通球囊5内部及操作杆1的腔体，其不仅限于圆形孔，还可以是正方形等其它形状，通孔7的排列也不受任何限制。所述的导向头3优选设计成半球形，也可以是其它曲面状，在引导本发明的输尿管结石阻挡取出器进入输尿管时不会损伤输尿管壁。所述的操作杆1其近端用于连接注射器，在其近端可设常闭单向气阀，用于封闭操作杆1的腔体，维持球囊5的充气状态。
本发明的输尿管结石阻挡取出器的使用方法如下：输尿管镜碎石术时，形成内窥镜 工作通道，置入内窥镜，拆开本发明的输尿管结石阻挡取出器的出厂包装，手持手柄2将操作杆1的导向头端进入到输尿管，绕开结石并到达结石上方，然后通过操作杆1的近端向操作杆1的腔体内充气或注水，此时空气或水流通过通道7进入到球囊5的腔内，球囊5膨胀成环状，封堵膜6随之被支撑成型，与输尿管壁严密贴合，然后一边通过内窥镜工作通道向输尿管注水，一边向近端拖动操作杆1，碎石在不断的水流冲击下被冲入到球囊5和封堵膜6之间的空间内，或随着水流不断搅动，在操作杆1的缓慢拖动下并在水流的带动下向下流动直至膀胱。本发明的输尿管结石阻挡取出器体积小，易于置入输尿管，不会推动结石向肾脏逆行和造成输尿管壁损伤，且能完全封堵输尿管，有效防止结石及结石碎片被灌注水流重回肾内，不易发生结石嵌顿的情况，拖移取石过程不易变形和摩擦输尿管壁，能一次性取出全部结石，达到高效排石的目的。
本发明的输尿管结石阻挡取出器不仅可用于输尿管结石的封堵和移除，还可应用于其他体腔的封堵和异物移除，包括但不限于以下应用：用于肾结石的封堵及移除，血管血栓的封堵和移除，血管穿刺孔封堵止血，体腔异物的封堵和移除如气管、肠道中异物的处理。
以上所述仅是本发明的优选实施方式，应当指出，对于本技术领域的普通技术人员，在不脱离本发明方法的前提下，还可以做出若干改进和补充，这些改进和补充也应视为本发明的保护范围。

Claims (10)

  1. 一种异形球囊式输尿管结石阻挡取出器，设有近端开口、远端封闭且中空的操作杆，其特征在于，操作杆远端区段设有嵌合槽，所述的嵌合槽上设有环状的球囊，所述的球囊外周设有封堵膜，且球囊的内部与操作杆的腔体连通。
  2. 根据权利要求1所述的输尿管结石阻挡取出器，其特征在于，所述的嵌合槽环绕操作杆一周，所述的球囊环绕嵌合槽一周，且球囊所在的平面与操作杆垂直。
  3. 根据权利要求1所述的输尿管结石阻挡取出器，其特征在于，所述的封堵膜环绕球囊的外周至少一圈。
  4. 根据权利要求3所述的输尿管结石阻挡取出器，其特征在于，所述的封堵膜为单张膜，或者由多个瓣膜组成。
  5. 根据权利要求4所述的输尿管结石阻挡取出器，其特征在于，所述的封堵膜由多个瓣膜组成，所述的瓣膜重叠排列，环绕球囊若干圈。
  6. 根据权利要求1所述的输尿管结石阻挡取出器，其特征在于，所述的封堵膜的下缘向操作杆的近端倾斜。
  7. 根据权利要求1所述的输尿管结石阻挡取出器，其特征在于，所述的封堵膜固定在球囊直径最大的外周线上。
  8. 根据权利要求1所述的输尿管结石阻挡取出器，其特征在于，所述操作杆与球囊连接的部位设有通孔。
  9. 根据权利要求8所述的输尿管结石阻挡取出器，其特征在于，所述的通孔环绕操作杆排布。
  10. 根据权利要求1所述的输尿管结石阻挡取出器，其特征在于，所述的操作杆远端区段的顶端设有表面为曲面的导向头。
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