WO2015055070A1 - 一种精确定位人体管腔支架置入器 - Google Patents

一种精确定位人体管腔支架置入器 Download PDF

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Publication number
WO2015055070A1
WO2015055070A1 PCT/CN2014/086822 CN2014086822W WO2015055070A1 WO 2015055070 A1 WO2015055070 A1 WO 2015055070A1 CN 2014086822 W CN2014086822 W CN 2014086822W WO 2015055070 A1 WO2015055070 A1 WO 2015055070A1
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Prior art keywords
tube
outer tube
inner tube
stent
human body
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PCT/CN2014/086822
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English (en)
French (fr)
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黄景陶
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黄景陶
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Publication of WO2015055070A1 publication Critical patent/WO2015055070A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts

Definitions

  • the invention belongs to the technical field of clinical medical instruments, and particularly relates to an inserter for accurately positioning a human body lumen support for the purpose of supporting a human lumen and keeping the lumen open.
  • the intraluminal stent is a common treatment for stenosis and obstruction caused by benign and malignant diseases of the esophagus, stomach, tracheobronchial, intestinal, biliary tract and prostate.
  • the stent device currently used such as the esophageal stent inserter with the patent number 95239801.X and the endoscope direct vision stent inserter with the patent number 99220256.6 are all sleeved and can be sleeved with the outer tube, the middle tube and the inner tube. Sliding structure, but lacking the positioning fixture of the bracket.
  • the inner bracket is mostly made of a metal mesh bracket.
  • the stent When the stent is compressed and placed in the stent inserter, it will become significantly longer, and when it is released, it will be significantly shortened.
  • the final release position of the stent is affected by the narrow lumen shape and the smoothness of the tube wall.
  • the effects of various factors such as the elastic force of the stent and the external frictional resistance, the smoothness of the inner wall of the outer tube, the release speed of the stent, and especially the operation skills of the physician, make it difficult to accurately position and release the stent, and often need to be adjusted or removed after the stent is released. This not only greatly increases the operation time and patient suffering, but also increases the chances of surgical accidents and complications, and also limits the development of such technologies in primary hospitals.
  • the present invention provides a solution to the problem of the prior art, which can solve the problem of displacement of the stent device currently used in the release process of the stent due to the lack of a fixing device, and ensures a precise positioning of the body in the distal and proximal positions of the stent.
  • the stent of the lumen stent can solve the problem of displacement of the stent device currently used in the release process of the stent due to the lack of a fixing device, and ensures a precise positioning of the body in the distal and proximal positions of the stent.
  • the utility model can accurately position a human body lumen stent inserter, comprising an outer tube, a middle tube, an inner tube and a guiding head fixed to the distal end of the inner tube, and a handle is arranged on the outer tube, the middle tube and the inner tube, wherein the outer tube
  • the tube, the middle tube and the inner tube are sleeved and slidable relative to each other, and the inner tube is wrapped around a distal portion for positioning and releasing the filling/retracting anchoring balloon into which the stent is placed, the anchoring balloon and
  • An anchoring balloon catheter attached to the inner tube is in communication with the other end of the anchoring balloon catheter in communication with an anchoring balloon injection interface disposed adjacent the inner tube, the anchoring balloon injection interface being provided for A valve that anchors the balloon to fill/retract.
  • the anchoring balloon can be fixed to the distal part of the stenosis section at a distal position to function as a distal end of the fixed stent; the valve at the anchoring interface of the balloon can be used to control the opening and closing of the anchoring balloon catheter, the ball Closing the valve after filling the bladder maintains the filling of the balloon at a certain pressure.
  • the end of the middle tube abuts the proximal end of the bracket, and the two ends are connected end to end in the outer tube and outside the inner tube.
  • the outer wall of the middle tube between the middle tube handle and the outer tube handle is sleeved to be slidable along the middle tube and can be locked and fixed
  • the release limit ring at any position of the middle tube.
  • the outer tube can be retracted during the release of the stent until the stent is near the fully released and controllable position.
  • the anchoring balloon can be evacuated and the inner tube can be pulled back, so that the proximal portion of the stent is clamped between the distal end of the outer tube and the guiding head, and the outer tube can be adjusted to adjust the depth of the stent.
  • the distance between the middle tube and the outer tube can be clearly determined by the near-scale scale of the middle tube, and the release limit ring can be fixed with reference to the scale.
  • the position of the release ring can be estimated according to the length of the stent after being compressed in the outer tube, and the initial withdrawal distance of the outer tube is estimated.
  • the bracket is released, but at this time, the inner tube guide is retracted. , can still clamp the proximal section of the bracket to adjust the depth.
  • the position of the proximal end of the bracket can be clarified at any time.
  • the proximal side of the anchoring balloon is provided with an X-ray opaque stent distal development marker.
  • the outer tube and the middle tube are made of a transparent material. After the outer tube is inserted into the human body, the exposed portion and the corresponding inner tube portion respectively have an outer tube alignment marking line and an inner tube alignment marking line, and when the outer tube is aligned with the marking line and the inner tube When the alignment of the alignment line is aligned, the anchoring balloon is filled with its proximal end just at the distal opening of the outer tube.
  • An inner tube locking screw for fixing the inner tube insertion position is provided at a proximal end of the middle tube handle.
  • the outer tube is axially formed with an outer tube scale showing the insertion depth thereof, and the stent inserter can be inserted according to the distal position of the preset holder.
  • the outer tube of the middle tube between the handle of the middle tube and the handle of the outer tube is provided with a scale of the middle tube showing the distance of the outer tube from the state of being released relative to the withdrawal distance of the middle tube.
  • the middle tube there is a distal section of the middle tube indicating the depth of insertion of the middle tube from the distal end of the middle tube, and the outer tube is made of a transparent material.
  • the distal section of the middle tube indicates the proximal position of the stent.
  • the outer wall of the inner tube is provided with a scale indicating the insertion depth thereof. After the outer tube is inserted into the predetermined position, the inner tube and the anchoring balloon can be extended with reference to the scale, and the relative position of the anchoring balloon to the outer tube is clearly defined.
  • the lengths of the outer tube, the middle tube and the inner tube should satisfy the following conditions: when the distal end of the stent is located at the distal end of the outer tube and the distal end of the middle tube reaches the proximal end of the stent, the inner tube handle is pushed to the middle tube handle or the inner tube When the position of the screw is locked, the anchoring balloon just pushes out the distal opening of the outer tube and the balloon is filled and its proximal end is just at the distal opening of the outer tube.
  • the stent inserter can fix the distal end of the stent by anchoring the balloon; control the proximal end of the stent through the end of the middle tube; understand the distal and proximal positions of the stent through the scales of the outer, middle and inner tubes; and release the stent by releasing the limiting ring The degree can be adjusted before the stent is completely released.
  • the present invention has the advantages and positive effects: since the present invention adopts the above technical solution, that is, the present invention ensures that the stent is filled and fixed in the lumen by a filling/retracting anchoring balloon wrapped around the end of the inner tube. Release the distal position. On the premise that the distal end is fixed, the proximal end position of the stent can be ensured by pushing the middle tube and the reference tube scale. In addition, the position of the outer tube can be defined by releasing the limit ring, so that the position of the bracket can be adjusted by the cooperation with the inner tube guide head before the bracket is completely released.
  • the present invention can accurately position the distal and proximal ends of the stent without X-ray fluoroscopy, and can adjust the position midway to accurately release the stent. It avoids the complicated operation of re-adjusting or even removing the bracket after the position of the stent is displaced, which reduces the pain of the patient and greatly reduces the stent placement.
  • the difficulty of the operation makes the stent placement easier and faster. At the same time, it can reduce the technical threshold of stent placement and create a very favorable condition for the wider development of stent placement.
  • Figure 1 is a schematic view of the structure of the invention. (The anchor balloon is shown in the filled state, the stent is located in the distal end of the outer tube)
  • a precise positioning of a human lumen stent inserter includes an outer tube 18 , a middle tube 12 , an inner tube and a guiding head 28 disposed at a distal end of the inner tube, wherein the outer tube is provided with an outer tube
  • the handle 15 is provided with a middle tube handle 8 and a middle tube locking screw 13 on the middle tube; the proximal end of the inner tube is provided with a proximal end opening 2 of the inner tube, and the inner tube is located at the far side of the outer tube and can be externally
  • the bent portion of the tube is the inner tube soft portion 27, the remaining portion of the inner tube is the inner tube rigid portion 3, and the inner tube rigid portion is provided with the inner tube handle 5.
  • the outer tube, the middle tube and the inner tube are sleeved and slidable relative to each other, and the inner tube is wrapped in a distal portion for positioning and releasing the filling/retracting anchoring balloon 25 placed in the bracket 23.
  • the anchoring balloon is in communication with an anchoring balloon catheter distal opening 26 that is attached to the anchoring balloon catheter 6 on the inner tube; the other end of the anchoring balloon catheter is anchored to the proximal portion of the inner tube
  • the balloon injection interface is in communication with a valve 4 for controlling the filling/retraction of the anchoring balloon at the anchoring balloon injection interface.
  • the anchoring balloon After the anchoring balloon is filled, it can be fixed in the distal part of the lesion to the distal part of the lesion to play the role of the distal end of the fixed stent; the valve at the anchoring interface of the balloon can be used to control the opening and closing of the anchoring balloon catheter. Closing the valve after filling the balloon maintains the filling of the balloon at a certain pressure.
  • the proximal side of the anchoring balloon is provided with an X-ray opaque stent distal development marker 24.
  • the outer tube of the middle tube between the middle tube handle and the outer tube handle is provided with a release limiting ring 9 which can slide along the middle tube and can be locked and fixed at any position of the distal part of the middle tube, and passes through Release the limit ring locking screw 10 and the middle tube to lock.
  • the release limit ring is fixed in place according to the proximal scale of the middle tube, the outer tube can be released during the release of the stent The withdrawal is prevented until the stent is near the fully released and controllable position.
  • the anchoring balloon can be evacuated and the inner tube can be pulled back, so that the proximal portion of the stent is clamped between the distal end of the outer tube and the guiding head, and the outer tube can be adjusted to adjust the depth of the stent.
  • the outer tube of the middle tube between the handle of the middle tube and the handle of the outer tube is provided with a proximal section 11 of the middle tube showing the distance of the outer tube from the state of being released relative to the withdrawal direction of the middle tube, and the handle of the middle tube to the outer tube handle
  • a distal section 20 of the middle tube indicating the depth of insertion of the middle tube is formed on the outer wall of the middle tube.
  • the distance between the middle tube and the outer tube can be clearly determined by the near-scale scale of the middle tube, and the release limit ring can be fixed with reference to the scale.
  • the position of the release ring can be estimated according to the length of the stent after being compressed in the outer tube, and the initial withdrawal distance of the outer tube is estimated.
  • the bracket When the outer tube is retracted to the distance, the bracket is released, but at this time, the inner tube guide is retracted. , can still clamp the proximal section of the bracket to adjust the depth.
  • the position of the proximal end of the bracket can be clearly defined at any time. In the state where the middle tube is pushed against the proximal end of the stent, the distal section of the middle tube indicates the proximal position of the stent.
  • the outer tube and the middle tube are made of a transparent material, and the outer tube is inserted into the human body, and the exposed portion is provided with an outer tube alignment marking line 17. After the outer tube is inserted into the human body, the exposed portion corresponds to the inner tube position and the inner tube alignment marking line 16 is formed.
  • the outer tube alignment line is aligned with the inner tube alignment line, the anchored balloon is filled with its proximal end just at the distal end of the outer tube.
  • An inner tube locking screw 7 for fixing the inner tube insertion position is provided at a proximal end of the middle tube handle.
  • the outer tube is axially formed with an outer tube scale 19 showing its insertion depth, and the stent inserter can be inserted in accordance with the distal end position of the preset holder 23.
  • the inner tube outer wall is provided with an inner tube scale 21 indicating the insertion depth thereof. After the outer tube is inserted into the predetermined position, the inner tube and the anchoring balloon can be extended with reference to the scale, so as to clearly define the anchoring balloon to extend out of the outer tube. relative position.
  • the relative position of the balloon protruding from the outer tube can be known according to the relative distance between the inner and outer tube alignment lines.
  • An X-ray opaque stent proximal development marker 22 is formed at the distal end of the middle tube; an X-ray opaque stent distal development marker 24 is provided on the proximal side of the anchor balloon for X-ray Under the undeveloped bracket, the bracket can be released in the correct position under X-ray monitoring.
  • the outer tube is provided with a contrast injection interface 14 in communication with the lumen thereof, through which the contrast agent can be injected, and the X-ray monitoring down the treatment site to ensure that the stent is released in the correct position.
  • An inner tube locking screw for fixing the inner tube is disposed at a proximal end of the middle tube handle, and a middle tube locking screw for fixing the middle tube is disposed at a proximal end of the outer tube handle to avoid improper operation caused by improper operation of the assembly The movement.
  • the method of operation of the present invention is as follows:
  • the human body lumen stent device is suitable for stenting of stenosis caused by benign and malignant lesions of the esophagus, stomach, tracheobronchial, biliary tract, small intestine, colon, rectum, prostate and the like.
  • stenosis caused by benign and malignant lesions of the esophagus, stomach, tracheobronchial, biliary tract, small intestine, colon, rectum, prostate and the like.
  • only one lower esophageal cancerous stenosis is taken as an example.
  • the release state of the bracket 23 and the length of the compression in the state of the outer tube are separately measured. According to the position and length of the stenosis segment and the length of the stent release state, the length of the stent and the placement distance of the upper and lower ends were estimated. Calculate and fix the release stop ring 9 in place according to the length of the compressed state of the bracket to ensure that the outer tube is retracted to the position. The depth can still be adjusted by the guide head 28 holding the bracket with the end of the outer tube.
  • the relative position of the inner tube alignment line and the outer tube alignment line may also be referred to, and after the inner tube and the anchoring balloon 25 are extended to the appropriate position, the balloon injection interface is anchored to the appropriate capacity.
  • the gas is filled and anchored to the balloon, and the filling degree is fixed to the lumen by the anchoring balloon, and the normal operation force is not suitable for the anchoring of the balloon, and the organ to be treated is not damaged by excessive expansion.
  • the inner tube handle can be moved back and forth with appropriate force to verify its degree of fixation, and then the valve is closed to keep the anchoring balloon full.
  • the release limit ring can be released to continue to withdraw the outer tube, so that the stent is completely released; the depth is not ideal, the position of the outer tube can be kept unchanged, the anchoring balloon is evacuated, and the inner tube is retracted. The proximal portion of the bracket is clamped between the distal end of the outer tube and the guiding head, and then the outer tube is used to adjust the depth of the bracket. After the adjustment is satisfactory, release the release limit ring and continue to withdraw the outer tube to completely release the bracket.
  • stent proximal development marker 22 For operation under X-ray, reference can also be made to the stent proximal development marker 22, the stent distal development marker 24, or the contrast agent is injected from the contrast injection interface to observe the local lumen condition and the relative position of the stent and the inserter, and assist the stent. Place the operation.

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Abstract

一种可精确定位人体管腔支架置入器，包括外管（18）、中管（12）、内管及引导头（28），在外管（18）、中管（12）和内管上均设有手柄（15，8，5），外管（18）、中管（12）和内管套接并可相对滑动，内管远段包绕一个用于定位释放所置入支架（23）的可充盈/回缩的锚定球囊（25），锚定球囊（25）与附着在内管上的锚定球囊导管（6）连通，锚定球囊导管（6）另一端与设置在内管近段的锚定球囊注射接口连通，锚定球囊注射接口处设有阀门（4）。

Description

一种精确定位人体管腔支架置入器 技术领域
本发明属于临床医疗器械技术领域，特别是涉及一种以支撑人体管腔、保持管腔通畅为目的的精确定位人体管腔支架的置入器。
背景技术
人体管腔内支架是治疗食管、胃、气管支气管、肠道、胆道及前列腺等器官的良、恶性疾病造成的管腔狭窄、梗阻的常用治疗手段。目前使用的支架置入器如专利号为95239801.X的食道支架置入器及专利号为99220256.6的内镜直视支架置入器均为外管、中管、内管相套接并可相对滑动的结构，但均缺乏支架的定位固定装置。目前的内支架多采用金属网状支架，该类型支架压缩放置于支架置入器内时，会明显变长，当其释放时又会明显缩短。现有技术中所使用的支架置入器在支架释放时，由于外管、中管及内管均与支架产生相对运动，因而使支架最终的释放位置会受到管腔狭窄形态、管壁光滑程度、支架弹力与外表摩擦阻力、外管内壁光滑程度、支架释放速度、尤其是医师操作技巧等多方面因素的影响，导致支架难以准确定位释放，常在支架释放后还需调整或取出重新放置。这样不仅大大增加了手术时间及病人的痛苦，而且还会加大手术意外及并发症的机会，同时也限制了基层医院该类技术的开展。
发明内容
本发明为解决公知技术中存在的技术问题而提供能够解决目前所用支架置入器由于缺乏固定装置而在支架释放过程中的移位问题，确保支架释放远、近端位置的一种精确定位人体管腔支架的置入器。
本发明为解决公知技术中存在的技术问题所采取的技术方案是：
一种可精确定位人体管腔支架置入器，包括外管、中管、内管及固定在内管远端的引导头，在外管、中管和内管上均设有手柄，所述外管、中管和内管套接并可相对滑动，所述内管远段包绕一用于定位释放所置入支架的可充盈/回缩的锚定球囊，所述锚定球囊与附着在内管上的锚定球囊导管连通，所述锚定球囊导管另一端与设置在内管近段的锚定球囊注射接口连通，所述锚定球囊注射接口处设有用于锚定球囊充盈/回缩的阀门。所述锚定球囊充盈后可固定于狭窄段以远适当部位，起到固定支架远端的作用；锚定球囊注射接口处的阀门，可用于控制锚定球囊导管的开闭，球囊充盈后关闭阀门可保持球囊一定压力的充盈状态。中管末端抵接支架近端，二者首尾相接位于外管内及内管外。
本发明还可以采用如下技术方案：
在所述中管手柄与外管手柄之间的中管外壁上套装有可沿中管滑动并可锁紧固定 于中管任意位置的释放限位环。根据中管近段刻度将该释放限位环固定于适当位置时，可在释放支架过程中外管后撤到支架接近完全释放而尚可控制的位置而被阻止。此时如支架位置不满意，可抽空锚定球囊并回撤拉紧内管，使支架近段夹持于外管远端及引导头之间，可持外管调整支架深度。通过中管近段刻度可明确中管与外管相对滑动的距离，并可参照该刻度固定释放限位环。释放限位环的位置可根据支架压缩于外管内之后的长度，估算一外管初步回撤距离，在外管后撤至该距离时，支架已接近释放，但此时回撤内管引导头时，仍能夹持支架近段以调整深度。此外依据中管远段刻度，可随时明确支架近端的位置。
所述锚定球囊的近侧设有不透X射线的支架远端显影标记。
所述外管和中管为透明材料制作，所述外管插入人体后外露部分及对应内管部分分别制有外管对齐标线及内管对齐标线，当外管对齐标线与内管对齐标线对齐时，所述锚定球囊充盈后其近端刚好位于外管远端开口处。
在所述中管手柄的近端设有用于固定内管插入位置的内管锁紧螺环。
所述外管轴向上制有显示其插入深度的外管刻度，可按照预置支架的远端位置插入支架置入器。
所述中管手柄至外管手柄之间的中管外壁上制有显示外管自待释放状态相对于中管回撤距离的中管近段刻度。
沿所述中管自中管远端有标示中管插入深度的中管远段刻度，外管为透明材料制作。在中管推抵住支架近端的状态下，中管远段刻度即标示支架近端位置。
所述内管外壁上制有标示其插入深度的刻度，在外管插入到预定位置后，可参照该刻度伸出内管及锚定球囊，明确锚定球囊伸出外管的相对位置。
所述外管、中管和内管的长度应满足如下条件：当支架远端位于外管内远端且中管远端抵达支架近端状态下、内管手柄推抵至中管手柄或内管锁紧螺环位置时，锚定球囊刚好推出外管远端开口且球囊充盈后其近端刚好位于外管远端开口处。
本支架置入器可通过锚定球囊固定支架远端；通过中管末端控制支架近端；通过外、中及内管刻度随时了解支架远、近端位置；通过释放限位环限定支架释放程度，使支架完全释放前仍可做位置调整。
本发明具有的优点和积极效果是：由于本发明采用上述技术方案，即本发明通过包绕于内管末端的可充盈/回缩的锚定球囊将其充盈固定于管腔，可确保支架释放远端位置。在远端固定的前提下，通过推抵中管及参照中管刻度，可确保支架释放近端位置。此外还可通过释放限位环，限定外管初步回撤位置，使在支架完全释放前，仍能通过与内管引导头的配合调整支架位置。因此，本发明可在不需要X光透视的条件下，精确定位支架的远、近端，并可中途调整位置，准确释放支架。避免了支架放置位置偏移后需再次调整甚至取出支架重新放置的复杂操作，减轻了病人的痛苦，大大降低了支架置入 手术的难度，使支架置入术更加简便、快捷；同时还可降低支架置入术的技术门槛，并为支架置入术的更广泛开展创造了非常有利条件。
附图说明
图1是发明的结构示意图。(图中所示锚定球囊为充盈状态，所述支架位于外管远端内)
图中：1、导丝；2、内管近端开口；3、内管硬性部；4、阀门；5、内管手柄；6、锚定球囊导管；7、内管锁紧螺环；8、中管手柄；9、释放限位环；10、释放限位环锁紧螺丝；11、中管近段刻度；12、中管；13、中管锁紧螺环；14、造影注射接口；15、外管手柄；16、内管对齐标线；17、外管对齐标线；18、外管；19、外管刻度；20、中管远段刻度；21、内管刻度；22、支架近端显影标记；23、支架；24、支架远端显影标记；25、锚定球囊；26、锚定球囊导管远端开口；27、内管软性部；28、引导头。
具体实施方式
为能进一步了解本发明的发明内容、特点及功效，兹例举以下实施例，并配合附图详细说明如下：
本发明中附图描述的实施例是示例性的，仅用于解释本发明，而不能理解为对本发明的限制。
请参阅图1，一种可精确定位人体管腔支架置入器，包括外管18、中管12、内管及设置在内管远端的引导头28，所述外管上设有外管手柄15，在中管上设有中管手柄8和中管锁紧螺环13；所述内管近端设有内管近端开口2，内管位于外管内远侧大部并可随外管弯曲部分为内管软性部27，内管其余部分为内管硬性部3，所述内管硬性部上设有内管手柄5。所述外管、中管和内管套接并可相对滑动，所述内管远段包绕一用于定位释放所置入支架23的可充盈/回缩的锚定球囊25。所述锚定球囊与附着在内管上的锚定球囊导管6的锚定球囊导管远端开口26连通；所述锚定球囊导管另一端与设置在内管近段的锚定球囊注射接口连通，所述锚定球囊注射接口处连接有用于控制锚定球囊充盈/回缩的阀门4。所述锚定球囊充盈后可固定于病变狭窄段以远适当部位，起到固定支架远端的作用；锚定球囊注射接口处的阀门，可用于控制锚定球囊导管的开闭，球囊充盈后关闭阀门可保持球囊一定压力的充盈状态。
本实施例中，所述锚定球囊的近侧设有不透X射线的支架远端显影标记24。
本实施例中，在所述中管手柄与外管手柄之间的中管外壁上套装有可沿中管滑动并可锁紧固定于中管远段任意位置的释放限位环9，并通过释放限位环锁紧螺丝10与中管锁紧。根据中管近段刻度将该释放限位环固定于适当位置时，可在释放支架过程中外管 后撤到支架接近完全释放而尚可控制的位置而被阻止。此时如支架位置不满意，可抽空锚定球囊并回撤拉紧内管，使支架近段夹持于外管远端及引导头之间，可持外管调整支架深度。
所述中管手柄至外管手柄之间的中管外壁上制有显示外管自待释放状态相对于中管回撤距离的中管近段刻度11，所述中管远段至外管手柄之间的中管外壁上制有标示中管插入深度的中管远段刻度20。通过中管近段刻度可明确中管与外管相对滑动的距离，并可参照该刻度固定释放限位环。释放限位环的位置可根据支架压缩于外管内之后的长度，估算一外管初步回撤距离，在外管后撤至该距离时，支架已接近释放，但此时回撤内管引导头时，仍能夹持支架近段以调整深度。此外可依据中管远段刻度，随时明确支架近端的位置。在中管推抵住支架近端的状态下，中管远段刻度即标示支架近端位置。
所述外管和中管为透明材料制作，所述外管插入人体后外露部分制有外管对齐标线17，在外管插入人体后外露部分对应内管位置制有内管对齐标线16，当外管对齐标线与内管对齐标线对齐时，所述锚定球囊充盈后其近端刚好位于外管远端开口处。
在所述中管手柄的近端设有用于固定内管插入位置的内管锁紧螺环7。
所述外管轴向上制有显示其插入深度的外管刻度19，可按照预置支架23的远端位置插入支架置入器。
所述内管外壁上制有标示其插入深度的内管刻度21，在外管插入到预定位置后，可参照该刻度伸出内管及锚定球囊，以便明确锚定球囊伸出外管的相对位置。
支架释放操作中可根据内、外管对齐标线的相对距离了解球囊伸出外管的相对位置。
在所述中管的远端制有不透X射线的支架近端显影标记22；在所述锚定球囊的近侧有不透X射线的支架远端显影标记24，用于在X线下不显影的支架，可在X线监视下在正确位置释放支架。
所述外管设有与之内腔连通的造影注射接口14，可通过该造影注射接口注入造影剂，在X线监视下行治疗部位造影以确保支架释放于正确位置。
在所述中管手柄的近端设有用于固定内管的内管锁紧螺丝，在所述外管手柄的近端有用于固定中管的中管锁紧螺丝，可避免误操作导致组件不当的移动。
本发明的操作方法如下：
本人体管腔支架置入器适用于食管、胃、气管支气管、胆道、小肠、结肠、直肠、前列腺等部位的良、恶性病变造成的管腔狭窄的支架置入治疗。本专利中仅以一食管下段癌性狭窄为例予以说明。
1、首先分别测量支架23释放状态及压缩在外管内状态下的长度。根据病变狭窄段的位置及长度及支架释放态长度，估算支架置入后的长度及上、下端的置入距离。根据支架压缩态长度，计算并固定释放限位环9于适当位置，以确保外管后撤到该位置时， 仍可通过引导头28与外管末端夹持支架以调整深度。
2、检查支架置入器各部操作是否正常，完全回撤内管至引导头近端完全收入外管末端，使中管末端抵接支架近端，支架远端抵接引导头近端，锁紧中管锁紧螺环13及内管锁紧螺环7。
3、通过胃镜插入导丝1越过狭窄段进入病变远段正常管腔，撤出胃镜保留导丝。将导丝末端插入引导头尖端开口并从内管近端开口引出。保持导丝深度不变，沿导丝插入支架置入器。
4、依外管刻度19插入至此前计算的支架下端位置，松开内管锁紧螺环，前推内管手柄5至中管手柄8或内管锁紧螺环，当支架远端位于外管内远端且中管远端抵达支架近端状态下，内管手柄推抵至中管手柄或内管锁紧螺环时，锚定球囊刚好推出外管远端开口，使球囊充盈后其近端刚好位于外管远端开口处。此时，也可参照内管对齐标线、外管对齐标线的相对位置，确定内管及锚定球囊25伸出外管至适当位置后，通过锚定球囊注射接口，以适当容量的气体充盈锚定球囊，充盈程度以锚定球囊固定于管腔、正常操作力度不致锚定球囊移位且不致因过度扩张损伤所治疗脏器为宜。可以适当力度前后移动内管手柄以验证其固定程度，然后关闭阀门以保持锚定球囊充盈。
5、松开中管锁紧螺环，两手分别握持外管手柄、中管手柄，持续以适当力度前抵中管手柄以保证中管末端、支架、锚定球囊依次抵接，此时中管远段刻度即显示支架近端深度。再后撤外管手柄至释放限位环处，由于此时支架仅余近端少部分留在外管中，此时中管远段刻度所标示的深度已非常接近支架完全释放后支架近端深度。如果此放置深度满意，可松开释放限位环继续后撤外管，使支架完全释放；如此深度不理想，可保持外管位置不变，抽空锚定球囊并回撤拉紧内管，使支架近段夹持于外管远端与引导头之间，再持外管调整支架深度。调整满意后，松开释放限位环继续后撤外管，完全释放支架。
如在X线下操作，还可参考支架近端显影标记22、支架远端显影标记24，或从造影注射接口注入造影剂，以观察局部管腔情况及支架、置入器相对位置，协助支架置入操作。

Claims (9)

  1. 一种可精确定位人体管腔支架置入器，包括外管、中管、内管及内管远端的引导头，在外管、中管和内管上均设有手柄，所述外管、中管和内管套接并可相对滑动，其特征在于；所述内管远段包绕一用于定位释放所置入支架的可充盈/回缩的锚定球囊，所述锚定球囊与附着在内管上的锚定球囊导管连通，所述锚定球囊导管另一端与设置在内管近段的锚定球囊注射接口连通，所述锚定球囊注射接口处设有用于控制锚定球囊充盈/回缩的阀门。
  2. 根据权利要求1所述的一种可精确定位人体管腔支架置入器，其特征在于：在所述中管手柄与外管手柄之间的中管外壁上套装有可沿中管滑动并可锁紧固定于中管远段任意位置的释放限位环。
  3. 根据权利要求1所述的一种可精确定位人体管腔支架置入器，其特征在于：所述锚定球囊的近侧设有不透X射线的支架远端显影标记。
  4. 根据权利要求1所述的一种可精确定位人体管腔支架置入器，其特征在于：所述外管和中管为透明材料制作，所述外管插入人体后外露部分及对应内管部分分别制有外管对齐标线及内管对齐标线，当外管对齐标线与内管对齐标线对齐时，所述锚定球囊充盈后其近端刚好位于外管远端开口处。
  5. 根据权利要求1所述的一种可精确定位人体管腔支架置入器，其特征在于：在所述中管手柄的近端设有用于固定内管插入中管位置的内管锁紧螺环。
  6. 根据权利要求1所述的一种可精确定位人体管腔支架置入器，其特征在于：所述外管轴向上制有显示其插入深度的外管刻度。
  7. 根据权利要求1所述的一种可精确定位人体管腔支架置入器，其特征在于：所述中管手柄至外管手柄之间的中管外壁上制有显示外管自待释放状态相对于中管回撤距离的中管近段刻度。
  8. 根据权利要求1所述的一种可精确定位人体管腔支架置入器，其特征在于：所述外管和中管为透明材料制作，所述内管外壁上制有标示其插入深度的刻度。
  9. 根据权利要求1所述的一种可精确定位人体管腔支架置入器，其特征在于：所述外管、中管、内管的长度应满足当支架远端位于外管内远端且中管远端抵达支架近端状态下，内管手柄推抵至中管手柄或内管锁紧螺环位置时锚定球囊刚好推出外管远端开口且球囊充盈后其近端刚好位于外管远端开口处的要求。
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CN102274575A (zh) * 2011-05-17 2011-12-14 微创医疗器械(上海)有限公司 一种球囊扩张导管
CN202908885U (zh) * 2012-07-20 2013-05-01 易生科技(北京)有限公司 一种锥体远端外管
CN103479453A (zh) * 2013-10-14 2014-01-01 黄景陶 一种精确定位人体管腔支架置入器
CN203506937U (zh) * 2013-10-14 2014-04-02 黄景陶 一种精确定位人体管腔支架置入器

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CN110025415A (zh) * 2018-01-12 2019-07-19 上海微创心脉医疗科技股份有限公司 一种医用植入物释放系统的手柄
CN109350324A (zh) * 2018-12-06 2019-02-19 南京法迈特科技发展有限公司 远端可弯曲的支架植入装置
CN109350324B (zh) * 2018-12-06 2023-11-14 南京法迈特科技发展有限公司 远端可弯曲的支架植入装置

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