WO2016141631A1 - 一种介入器械输送系统 - Google Patents

一种介入器械输送系统 Download PDF

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Publication number
WO2016141631A1
WO2016141631A1 PCT/CN2015/078878 CN2015078878W WO2016141631A1 WO 2016141631 A1 WO2016141631 A1 WO 2016141631A1 CN 2015078878 W CN2015078878 W CN 2015078878W WO 2016141631 A1 WO2016141631 A1 WO 2016141631A1
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Prior art keywords
point
development
interventional
interventional instrument
sheath
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PCT/CN2015/078878
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English (en)
French (fr)
Inventor
王建安
吕守良
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杭州启明医疗器械有限公司
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Publication of WO2016141631A1 publication Critical patent/WO2016141631A1/zh

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Classifications

    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath
    • 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

Definitions

  • the present invention relates to the field of medical device technology, and in particular, to an interventional instrument delivery system.
  • Interventional surgery is a treatment developed on the basis of the development of these modern technologies.
  • the orientation of medical imaging equipment is the key to complete interventional surgery. It plays an important role in interventional therapy, enabling interventional operation in real and stereo The image is guided.
  • the interventional instrument is guided by a modern digital medical X-ray imaging device, and the interventional medical device is sent to the lesion for treatment by a device such as a puncture needle, a guide wire, a catheter, etc., and can be obtained with the same trauma as a small trauma. Or better treatment effect.
  • a device such as a puncture needle, a guide wire, a catheter, etc.
  • CT is an X-ray illumination imaging in multiple directions. Since X-ray is a kind of light-projection projection, X-ray image can only display the plane structure of the object in the illumination direction. There is overlap between objects or objects, and information such as overlapping levels cannot be displayed. Moreover, directly measuring the image formed by the light and shadow projection, the actual size of the projection object cannot be obtained, and the reference quantity in the same image is first selected to obtain the size ratio, and then the measurement is obtained.
  • Chinese Patent Application No. 201010150780.X discloses a convenient implantable artificial valve replacement device and a stent.
  • the prior delivery device of the interventional instrument fixes the interventional instrument on a stent fixation head, and the stent is fixed.
  • the front end has a streamlined guide head, and the rear end is connected with a catheter for implantation.
  • the interventional instrument is engaged into the stent fixation head of the delivery device, and the interventional instrument is pushed from the entrance of the blood vessel to the diseased valve through the catheter.
  • the interventional instrument is released, and the stent is inflated by the body temperature, and the blade of the human valve is pushed onto the vessel wall to complete the position, and then the catheter and the stent holder and the guide head are withdrawn.
  • the interventional instrument is composed of a stent and a trilobal valve fixed in the stent, wherein the stent is a mesh-shaped tubular structure composed of aortic stents, valve stents and flow-advance stents, which are sequentially connected, and the valve stent is installed in the valve stent.
  • Artificial valve is composed of aortic stents, valve stents and flow-advance stents, which are sequentially connected, and the valve stent is installed in the valve stent.
  • the release position of the interventional instrument is quite critical, and the position of the artificial valve should correspond to the position of the human valve. If the release position of the interventional device is deviated, it will cause a circumferential leak, and some blood will be from the artificial valve. The periphery of the replacement device enters.
  • three development points can also be fixed along the circumferential direction of the external wall of the interventional instrument, which is to sew the gold piece on the interventional instrument because it is seen during the actual operation.
  • the two-dimensional developed image is originally three stereoscopically arranged on the interventional instrument. After two-dimensional projection, there is no way to confirm that the valve development point is actually in front of or behind the interventional instrument, and there is no way to confirm the valve. Is the location reasonable?
  • the present invention provides an interventional instrument delivery system that eliminates the need to set a visualization point to more accurately determine the position of the interventional instrument.
  • An interventional instrument delivery system includes a control handle, a sheath, and a sheath core disposed within the sheath, the distal end of the sheath core having at least two development points axially distributed by the sheath core.
  • the interventional instrument is stably installed at the distal end of the sheath core and assembled into the sheath tube, and the development point on the sheath core is matched with the key position of the interventional instrument.
  • the development point on the sheath core at the front end of the delivery system is clearly visible in the X-ray image.
  • the contrast agent With the contrast agent, the development point reaches the set position and then the sheath is released to release the interventional instrument.
  • the interventional device is released, and the device can fully integrate with the lesion to repair the function of the human lesion with the best effect.
  • the sheath Since the development point is on the sheath core, the sheath is retracted after positioning And the device release process ⁇ , the position of the development point does not change, the development point is relatively stable, providing a reference point for the judgment and execution steps of the subsequent surgery, reducing the number of times the contrast agent is continuously used to determine the position of the lesion, greatly reducing the contrast agent will increase The burden of the patient's kidneys.
  • the development point is two or three.
  • X-ray image limitation measuring the size of an object in the X-ray image, and selecting a reference object that knows the specific size, and calculating the actual size of other parts in the image by the principle of the same scale. If the size of the diseased tissue is to be reconfirmed before the release of the interventional device, since the sheath installation segment has reached the nearest position of the lesion, the size of the lesion is measured by the distance between the development points in the sheath core, regardless of the resolution. (Select other objects to judge the boundary of the object), Accuracy (developing point distance preset), Reliability (the closer the measurement tissue is, the smaller the image deformation amount) can be more accurate.
  • the doctor's operation is to select a 5Fr pigtail catheter at a certain distance from the tissue as a calibration value, and then measure the diameter of the artificial valve after the calibration is completed.
  • the pigtail catheter is thinner, and the measurement error is large in the image, and there is a certain distance from the lesion position.
  • the amount of image deformation also increases the error amount.
  • the distance between two adjacent development points in the development point is 4 to 9 mm.
  • the development point is a first development point, a second development point, and a third development point sequentially distributed from the distal end to the proximal end, wherein the first development point and the second development point are 4-6 mm apart.
  • the distance between the second developing point and the third developing point is 4 to 9 mm.
  • the development point is fixed on the sheath core.
  • the development dot pitch can be used as a reference size in an X-ray image.
  • the developing point is a gold ring that can tightly slide on the sheath core.
  • the gold surrounds the sheath core one week, which facilitates the observation of the development point by the operation, and the development point can be clearly seen from any angle of the sheath core tube.
  • the gold ring can also surround the sheath core half, and the effect is also Far better than existing technology.
  • the development point is a C-shaped gold ring that can slide on the sheath core.
  • the outer wall of the sheath core tube is provided with at least two grooves distributed along the axial direction thereof for mounting the gold ring.
  • the dimension of the groove along the axial direction of the sheath core is 0.5 ⁇ 1 mm.
  • the development point is positioned on the sheath core to better meet different types of interventional instruments.
  • FIG. 1 is a schematic illustration of an interventional instrument delivery system having two visualization points.
  • FIG. 2 is a schematic illustration of an interventional instrument delivery system having two development points without a gold plate.
  • FIG. 3 is a schematic illustration of an interventional instrument delivery system having two visualization points positioned at a target location.
  • FIG. 4 is a schematic illustration of an interventional instrument delivery system release interventional instrument having two visualization points.
  • FIG. 5 is a schematic illustration of an interventional instrument delivery system having three visualization points positioned at a target location.
  • an interventional instrument delivery system includes a control handle (not shown), a sheath 1 and a set
  • the sheath core 2 in the sheath tube 1 can realize the axial sliding of the sheath tube 1 along the sheath core 2 by operating the control handle, thereby realizing the release of the interventional instrument.
  • the sheath core 2 includes a core tube 201.
  • the distal end of the core tube 201 is fixed with a bow I guide 202 and an interventional instrument fixation head 203.
  • the core tube 201 is located between the guide head 202 and the interventional instrument fixation head 203. Place the mounting section of the interventional instrument.
  • the mounting portion of the core tube 201 is provided with a first developing point 204 and a second developing point 205.
  • the distance between the first developing point 204 and the guiding head 202 is 5 mm, and the second developing point 205 and the first developing point 204 are The distance is 6mm.
  • the first development point 204 and the second development point 205 are respectively provided with a mounting groove 206 at a position corresponding to the circumferential direction of the core tube 201, and the mounting groove 206 is fixedly mounted.
  • Golden ring The mounting groove 206 has a dimension of 1 mm along the axial direction of the core tube 201.
  • the gold ring may be an unclosed C-shaped structure or a closed ring.
  • the interventional device of the present invention includes an interventional aortic valve and an interventional pulmonary valve.
  • the interventional instrument delivery system of the present invention pushes the interventional aortic valve 3 from the entrance of the blood vessel to the valve 4 of the lesion, and the sheath 1 can be retracted by operating the control handle. Release of the interventional aortic valve 3.
  • the interventional aortic valve 3 comprises a stent made of a memory alloy and a prosthetic valve sewed on the stent. When the interventional aortic valve 3 is exposed to the blood vessel without the restraint of the sheath 1, the intervention is performed under the action of blood temperature. The aortic valve expands itself to complete the release.
  • the position of the interventional aortic valve 3 must be positioned before the interventional aortic valve 3 is released. Only when the interventional aortic valve 3 is released at the target position can it play its due role. If there is a deviation in the release position, Causes a weekly leak, and some blood enters from the periphery of the interventional aortic valve.
  • BACKGROUND OF THE INVENTION Imaging devices that have been introduced for interventional surgery use X-ray illumination imaging to directly measure images formed by light and shadow projections, and the actual size of the projection object cannot be obtained. Therefore, the measurement of the image requires a calibration value, usually 5Fr pigtail catheter 5 As the calibration value, the diameter of the interventional aortic valve is measured after the calibration is completed, but usually the pigtail catheter needs to be withdrawn during the interventional aortic valve release process, and the first development point 204 and the second development can be performed at this time. The distance between the points 205 is taken as a calibration value, and the advantage is that it is in the same position as the valve 4 of the lesion, and is a large-sized measurement, and the error is very small.
  • the invasive aortic valve 3 is stably mounted on the sheath 1 of the sheath 2 and the interventional aorta
  • the flap 3 is compressed and assembled into the sheath 1, wherein one end of the axial direction of the interventional aortic valve 3 is mounted on the stent holder 203 and the other end is resting on the guide head 202.
  • the position of each development point of the sheath core 2 corresponds to the key point of the artificial valve on the interventional aortic valve 3, and as long as the position of the development point on the sheath core 2 corresponds to the position of the diseased valve 4, the key of the prosthetic valve The point also corresponds to the lesion location.
  • the interventional aortic valve 3 is first pushed from the entrance of the blood vessel to the vicinity of the diseased valve 4; the interventional aortic valve is initially initiated by the first development point 204.
  • the first developing point is directly The distance between the second development points is measured as a calibration value; the position of the interventional aortic valve 3 is determined and released, and the interventional aortic valve 3 expands under the action of body temperature, and The blade of the diseased valve 4 is pushed onto the blood vessel wall to complete the release; after the release is completed, the diameter of the interventional aortic valve is measured again by using the distance between the first development point and the second development point as a calibration value to determine the artificial Whether the valve is fully expanded.
  • FIG. 5 also shows the case where three development points are arranged on the sheath core, and the second development point 205 is located between the third development point 20 7 and the first development point 204, and three development points are provided, which can completely realize two The effect of the development point , and the third development point 207 can serve as an auxiliary reference point for the positioning ⁇ .
  • the distance between the third developing point 207 and the second developing point 205, and the distance between the second developing point 205 and the first developing point 204 may be the same or different, so that a plurality of developing points may be set. Calibration values to facilitate the delivery of different types of interventional instruments for calibration and measurement.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
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Abstract

一种介入器械输送系统，包括控制手柄、鞘管（1）和置于鞘管（1）内的鞘芯（2），鞘芯（2）远端设有延鞘芯（2）轴向分布的至少两个显影点（204，205）。显影点（204，205）位于直径很小的鞘芯（2）上，几乎不会因为观察角度的问题，而造成观察到的显影点（204，205）位置与实际位置有偏差，手术时定位更简单，更准确。由于无需在每个介入器械上缝制三个金片作为显影点，显影点（204，205）设置在介入器械输送系统上，可以被重复利用。作为显影点的金片不用缝制在介入器械上，避免了植入人体的介入器械在长期使用过程中金片脱落带来的二次伤害。

Description

一种介入器械输送系统 技术领域
[0001] 本发明涉及医疗器械技术领域， 尤其涉及一种介入器械输送系统。
背景技术
[0002] 医学技术和现代数字医学影像技术的飞速发展， 各种高影像设备帮助医生在无 需通过外科手术打幵人体组织就可以精确的看到人体内部结构、 病变大小及其 与周围组织的关系。 介入手术治疗就是在这些现代科技发展的基础上发展起来 的治疗方法， 医学影像设备的导向是完成介入手术治疗的关键， 在介入治疗中 发挥了重要作用， 使介入性操作能在实吋和立体的影像引导下进行。 通常， 介 入器械在现代数字化的医学 X射线影像设备的引导下， 用穿刺针、 导丝、 导管等 装置将介入医疗器械送至病变部位进行治疗的过程， 能以微小的创伤获得与外 科手术相同或更好的治疗效果。
[0003] 与 B超是通过超声波反射来成像不同， CT是多个方向上的 X光照射成像， 由于 X光是一种光影投影， 所以 X光影像只能显示照射方向的物体平面结构， 如果物 体内部或物体间发生重叠， 无法显示重叠层次等信息。 并且， 直接测量光影投 影所成影像， 无法得到投影物实际尺寸， 需先选择同影像中的参照物获取尺寸 比例量， 再测算而得。
[0004] 申请号为 201010150780.X的中国专利文献公布了一种方便植入的人造瓣膜置换 装置及支架， 现有介入器械的输送系统是将介入器械固定在一个支架固定头上 ， 该支架固定头前端带有流线型的引导头， 后端连接有导管， 进行植入吋， 首 先将介入器械卡合到输送装置的支架固定头中， 通过导管将介入器械从血管的 入口处推送到病变的瓣膜部位， 再释放介入器械， 介入器械在体温的作用下其 支架会膨胀幵， 将人体瓣膜的叶片推压到血管壁上完成就位， 然后再将导管以 及支架固定头和引导头抽出。
[0005] 其中介入器械由支架和固定在支架内的三叶瓣膜构成， 支架为由依次连接的主 动脉支架、 瓣膜支架和流进道支架构成的网状的筒形结构， 瓣膜支架内安装有 人造瓣膜。
[0006] 在进行手术吋， 介入器械的释放位置相当关键， 人造瓣膜的位置要与人体瓣膜 的位置相对应， 如果介入器械的释放位置有偏差， 则会造成周漏， 部分血液会 从人造瓣膜置换装置的外围进入。
[0007] 手术吋， 看不到血管也看不到人体瓣膜， 只能通过打造影剂并借助造影设备在 一个较短吋间内看到人体瓣膜的位置， 做手术的医生需要在这段吋间通过输送 装置调整介入器械的位置。
[0008] 为了确定介入器械的位置， 还可在该介入器械的外壁沿自身的周向固定三个显 影点， 该显影点是将金片缝制在介入器械上， 因为在实际手术过程中看到的是 二维显影图像， 本来是立体布置在介入器械上的三个显影点， 经过二维投影后 ， 没有办法确认瓣膜显影点实际处于介入器械的前面还是后面， 也就没有办法 确认瓣膜的位置是否合理。
[0009] 另一方面， 这个三个显影点均采用金制作， 而且需要设置在每一个介入器械上 ， 成本很高。 制作工艺也比较复杂， 要非常细心地缝制在介入器械的瓣架上， 该显影点与介入器械一起长期留置在人体里， 显影点掉落的风险很大。
技术问题
[0010] 本发明提供了一种介入器械输送系统， 介入器械无需设置显影点， 更准确地确 定介入器械的位置。
问题的解决方案
技术解决方案
[0011] 本发明解决问题的技术方案为：
[0012] 一种介入器械输送系统， 包括控制手柄、 鞘管和置于鞘管内的鞘芯， 鞘芯远端 设有延鞘芯轴向分布的至少两个显影点。
[0013] 介入器械稳定安装在鞘芯远端， 并装配至鞘管内， 鞘芯上的显影点与介入器械 关键位置点匹配对应设置。 介入器械释放过程中， 输送系统前端设置在鞘芯上 的显影点在 X光影像里清晰可见， 在造影剂配合下， 显影点到达设定位置后回撤 鞘管释放介入器械， 即在此位置释放介入器械， 器械能与病变处充分结合， 以 最佳效果的修复人体病变处功能。 由于显影点在鞘芯上， 在定位后的鞘管回撤 和器械释放过程吋， 显影点位置不改变， 显影点相对稳定定位， 为后续手术的 判断和执行步骤提供参考点， 减少了不断打造影剂来确定病变位置的次数， 大 大减轻了造影剂会增加病人肾造成的负担。
[0014] 相对于在介入器械上的显影点， 由于介入器械从鞘管内释放后， 其形状会逐渐 恢复到记忆形状而发生变化， 显影点也随之移动， 对于病变位置的标定参考性 大大降低； 目前介入器械上的显影点， 其作用只有一个就是在器械释放前的初 始定位， 加上 X光影像的局限性， 在介入器械释放形变后显影点的前后位置关系 无法判断影点位置只能作为参考， 还是重新需通过造影等方式结合确认关键位 置点。
[0015] 优选的， 显影点为两个或三个。
[0016] X光影像局限， 测量 X光影像内物体尺寸， 需选择一个知道具体尺寸的参照物 ， 通过同比例原理， 计算该影像中其他部分的实际尺寸。 在介入器械释放前若 想再次确认病变组织尺寸， 由于鞘管安装段已到达病变位置最近处， 此吋若通 过鞘芯内显影点间的距离作为参照物来测量病变组织尺寸， 无论从清晰度 （选 择其他物体要判断物体边界） 、 准确度 （显影点距离预设定） 、 可靠度 （离测 量组织越近， 影像变形量越小） 都能更精准。
[0017] 目前， 医生的操作都是选择离组织有一定距离的 5Fr的猪尾导管作为标定值， 标定完成后再对人造瓣膜直径进行测量。 猪尾导管的较细， 在影像中对其进行 测量误差较大， 且离病变位置有一定距离， 影像变形量不同也增加了误差量。 优选的， 所述显影点中相邻两个显影点间距为 4~9mm。
[0018] 优选的， 所述显影点为由远端至近端依次分布的第一显影点、 第二显影点和第 三显影点， 其中第一显影点和第二显影点间距 4~6mm， 第二显影点和第三显影 点之间间距 4~9mm。
[0019] 优选的， 所述显影点固定在鞘芯上。
[0020] 显影点间距， 在 X光影像中可作为参照物尺寸。
[0021] 优选的， 所述显影点为可在鞘芯上紧配合滑动的金环。
[0022] 所述金环绕鞘芯一周吋， 利于手术吋对显影点的观察， 无论从鞘芯管周向的任 意角度观察都能清楚的看到显影点。 所述金环也可以将鞘芯半包围， 其效果也 远好于现有技术。
[0023] 优选的， 所述显影点为可在鞘芯上滑动的 C形金环。
[0024] 优选的， 所述鞘芯管的外壁设有沿自身轴向分布用于安装金环的凹槽至少两个
[0025] 优选的， 所述凹槽沿鞘芯轴向的尺寸为 0.5~lmm。
[0026] 显影点在鞘芯上移动定位， 能够更好的满足不同型号的介入器械。
发明的有益效果
有益效果
[0027] 本发明的有益效果在于：
[0028] ( 1) 操作简单、 定位更准， 显影点位于直径很小的鞘芯上， 几乎不会因为观 察角度的问题， 而造成观察到的显影点位置与实际位置有偏差， 手术吋定位更 简单， 更准确。
[0029] (2) 成本低， 无需在每个介入器械上缝制三个金片作为显影点， 显影点设置 在介入器械输送系统上， 可以被重复利用。
[0030] (3) 风险小， 作为显影点的金片不用缝制在介入器械上， 避免了植入人体的 介入器械在长期使用过程中金片脱落带来的二次伤害。
对附图的简要说明
附图说明
[0031] 图 1为具有两个显影点的介入器械输送系统示意图。
[0032] 图 2为具有两个显影点的介入器械输送系统未安装金片吋的示意图。
[0033] 图 3为具有两个显影点的介入器械输送系统定位于目标位置的示意图。
[0034] 图 4为具有两个显影点的介入器械输送系统释放介入器械的示意图。
[0035] 图 5为具有三个显影点的介入器械输送系统定位于目标位置的示意图。
本发明的实施方式
[0036] 下面结合具体实施例对本发明作进一步说明。
[0037] 参考图 1， 一种介入器械输送系统， 包括控制手柄 （图中未示出） 、 鞘管 1和置 于鞘管 1内的鞘芯 2， 通过操作控制手柄可以实现鞘管 1沿鞘芯 2的轴向滑动， 从 而实现介入器械的释放。
[0038] 鞘芯 2包括芯管 201， 芯管 201的远端固定有弓 I导头 202和介入器械固定头 203， 芯管 201处于引导头 202和介入器械固定头 203之间的部位为用于放置介入器械的 安装段。
[0039] 芯管 201的安装段上设有第一显影点 204和第二显影点 205， 第一显影点 204与引 导头 202的距离为 5mm， 第二显影点 205与第一显影点 204的距离为 6mm。
[0040] 如图 2所示， 第一显影点 204和第二显影点 205对应的位置各设有一个安装槽 206 ， 安装槽 206沿芯管 201的周向分布， 安装槽 206用于固定安装金环。 安装槽 206 沿芯管 201轴向的尺寸均为 lmm。 金环可以是未闭合的 C型结构， 也可以是闭合 的环形。
[0041] 本发明所述的介入器械包括介入式主动脉瓣和介入式肺动脉瓣等。 如图 3和图 4 所示， 采用本发明的介入器械输送系统将介入式主动脉瓣 3从血管的入口处推送 到病变的瓣膜 4处， 通过操作控制手柄使鞘管 1回缩即可实现介入式主动脉瓣 3的 释放。 介入式主动脉瓣 3包括由记忆合金制成的支架以及缝制在支架上的人工瓣 膜， 当介入式主动脉瓣 3暴露于血管中没有了鞘管 1的束缚， 在血液温度作用下 介入式主动脉瓣自行膨胀幵来完成释放。 但是释放介入式主动脉瓣 3前必须对介 入式主动脉瓣 3的位置进行定位， 只有将介入式主动脉瓣 3在目标位置释放才能 起到应有的作用， 如果释放位置有偏差， 则会造成周漏， 部分血液会从介入式 主动脉瓣的外围进入。
[0042] 背景技术已经介绍介入手术的成像设备采用 X光照射成像， 直接测量光影投影 所成影像， 无法得到投影物实际尺寸， 所以影像的测量需要有一个标定值， 通 常以 5Fr的猪尾导管 5作为标定值， 标定完成后再对介入式主动脉瓣的直径进行测 量， 但通常在介入式主动脉瓣释放过程中需要撤回猪尾导管， 这吋候就可以以 第一显影点 204和第二显影点 205之间的距离作为标定值， 优点是和病变的瓣膜 4 处于同一位置， 并且是大尺寸测量， 误差会非常小。
[0043] 下面结合图 3和图 4介绍本发明的介入器械输送系统使用过程：
[0044] 将介入式主动脉瓣 3稳定安装鞘管 1内在鞘芯 2的安装段上， 并将介入式主动脉 瓣 3压缩后装配至鞘管 1内， 其中介入式主动脉瓣 3轴向的一端安装在支架固定头 203上， 另一端靠在引导头 202上。 鞘芯 2各显影点的位置与介入式主动脉瓣 3上 的人工瓣膜的关键点位对应， 只要鞘芯 2上显影点的位置与病变的瓣膜 4的位置 对应上了， 那么人工瓣膜的关键点位也与病变位置对应了。
[0045] 进行介入式主动脉瓣的植入手术吋， 首先将介入式主动脉瓣 3从血管的入口处 推送到病变的瓣膜 4附近； 通过第一显影点 204对介入式主动脉瓣进行初始定位 ， 观察第二显影点 205的位置， 确保第二显影点 205的位置不能低于病变的瓣膜 4 的瓣环； 此吋， 若想再次确认病变组织结构尺寸， 则直接以第一显影点和第二 显影点之间的距离作为标定值进行测量即可确认； 介入式主动脉瓣 3的位置确定 好后进行释放， 介入式主动脉瓣 3在体温的作用下其支架会膨胀幵， 并将病变的 瓣膜 4的叶片推压到血管壁上完成释放； 释放完成后， 再次以第一显影点和第二 显影点的间距作为标定值， 对介入式主动脉瓣的直径进行测量， 以判断人造瓣 膜是否膨胀完全。
[0046] 图 5还展示了鞘芯上设置三个显影点的情况， 第二显影点 205位于第三显影点 20 7和第一显影点 204之间， 设置三个显影点吋完全可以实现两个显影点吋的效果 ， 而且第三显影点 207可以作为定位吋的辅助参考点。 第三显影点 207和第二显 影点 205之间， 以及第二显影点 205和第一显影点 204的距离可以相同也可以不相 同， 所以在具有三个显影点的情况下可以设定多个标定值， 以方便输送不同型 号的介入器械吋进行标定和测量。
[0047] 以上所述仅为本发明的优选实施例而已， 并不用于限制本发明， 对于本领域的 技术人员来说， 本发明可以有各种更改和变化。 凡在本发明的精神和原则之内 ， 所作的任何修改、 等同替换、 改进等， 均应包含在本发明的保护范围之内。

Claims

权利要求书
[权利要求 1] 一种介入器械输送系统， 包括控制手柄、 鞘管和置于鞘管内的鞘芯， 其特征在于： 所述鞘芯远端设有延鞘芯轴向分布的至少两个显影点。
[权利要求 2] 权利要求 1所述输送系统， 其特征在于： 所述显影点为两个或三个。
[权利要求 3] 权利要求 2所述的输送系统， 其特征在于： 所述显影点中相邻两个显 影点间距为 4~9mm。
[权利要求 4] 权利要求 1所述输送系统， 其特征在于： 所述显影点为由远端至近端 依次分布的第一显影点、 第二显影点和第三显影点， 其中第一显影点 和第二显影点间距 4~6mm， 第二显影点和第三显影点之间间距 4〜9mm。
[权利要求 5] 权利要求 1所述的输送系统， 其特征在于： 所述显影点固定在鞘芯上
[权利要求 6] 权利要求 1所述的输送系统， 其特征在于： 所述显影点为可在鞘芯上 紧配合滑动的金环。
[权利要求 7] 权利要求 1所述的输送系统， 其特征在于： 所述显影点为可在鞘芯上 滑动的 C形金环。
[权利要求 8] 如权利要求 7所述的输送系统， 其特征在于： 所述鞘芯的外壁设有沿 自身轴向分布用于安装金环的凹槽至少两个。
[权利要求 9] 如权利要求 8所述的输送系统， 其特征在于： 所述凹槽沿鞘芯轴向的 尺寸为 0.5~lmm。
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