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WO2019227358A1 - 分支血管的支架精准植入系统 - Google Patents

分支血管的支架精准植入系统 Download PDF

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Publication number
WO2019227358A1
WO2019227358A1 PCT/CN2018/089096 CN2018089096W WO2019227358A1 WO 2019227358 A1 WO2019227358 A1 WO 2019227358A1 CN 2018089096 W CN2018089096 W CN 2018089096W WO 2019227358 A1 WO2019227358 A1 WO 2019227358A1
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WO
WIPO (PCT)
Prior art keywords
stent
guide wire
blood vessel
implantation system
branch
Prior art date
Application number
PCT/CN2018/089096
Other languages
English (en)
French (fr)
Inventor
李雷
Original Assignee
Li Lei
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Li Lei filed Critical Li Lei
Priority to PCT/CN2018/089096 priority Critical patent/WO2019227358A1/zh
Publication of WO2019227358A1 publication Critical patent/WO2019227358A1/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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation

Definitions

  • the present disclosure relates to the field of stent implantation of blood vessels, and in particular, to a precision stent implantation system for branch blood vessels.
  • Vascular stenosis and occlusion is a disease with high disability and mortality.
  • stent implantation in blood vessels is one of the main treatment methods. This technique is used to deliver a stent to a diseased site for radial support of a blocked blood vessel.
  • the type, structure and implantation method of the vascular stent vary with the implantation position and the type of the disease to be treated.
  • widely used stents include bare stents, coated stents, etc.
  • the stent release methods can be divided into ball expansion methods and self-expanding methods.
  • the implantation method is to guide the compressed stent through the guide wire to the implantation position and then release it.
  • the ball expansion and release method is to fill the balloon airbag located inside the stent with liquid (gas) to expand the stent and then withdraw, and the self-expanding and release method is to evacuate the guide sheath containing the compressed stent. It is opened by the elastic structure of the bracket itself.
  • the self-expanding and release method is to evacuate the guide sheath containing the compressed stent. It is opened by the elastic structure of the bracket itself.
  • An implantation system for such a vascular stent usually includes a guide sheath, a guide core, and an ejector core for delivering the stent. This structure requires many steps when implanted in a stent, and is complicated and troublesome to operate.
  • An object of the present disclosure is to provide a stent precision implantation system for branch blood vessels.
  • the stent precision implantation system enables the stent to be accurately implanted in the branch blood vessels, and has a simple structure and easy operation.
  • the present disclosure provides a stent precise implantation system for branch blood vessels, the branch blood vessels including a main blood vessel communicating with each other and a branch blood vessel communicating with the main blood vessel
  • the stent precision implantation system includes a releasable A stent delivery device for receiving a stent and transporting the stent, a guide wire extending from the main blood vessel to the branch blood vessel, and a positioning guide wire extending along the main blood vessel
  • the stent delivery device is movably sleeved Outside the guide wire
  • the stent delivery device includes a restraint film releasably covering the outer periphery of the stent, and a limited hole is provided on the restraint film or on the stent. Sliding through the limiting hole to be able to position the bracket axially and circumferentially.
  • the limiting hole is formed by a limiting ring connected to the restraint membrane.
  • the bracket has a main body portion and an opening portion located at a rear end of the main body portion, the main body portion is formed into a straight tube structure, and the opening portion is formed into a trumpet structure.
  • the bracket has a main body portion and an opening portion located at a rear end of the main body portion, the main body portion is formed as a straight tube structure, and an opening plane of the opening portion is inclined with respect to an axis of the main body portion.
  • the stent delivery device includes a guide core movable along the guide wire, the limiting hole is provided on the restraint membrane, and the guide core is pressed tightly inside the stent in a tightened state.
  • the limiting hole is formed on the restraint film at a position corresponding to the opening portion.
  • the stent delivery device includes a guide core movable along the guide wire, and the guide core is connected to the restraint membrane.
  • the tethering membrane is sutured by a suture to cover the stent.
  • the suture includes an extension capable of extending outside the body.
  • the outer part of the extension is sheathed with a protective tube extending to the outside.
  • the stent after the stent enters the branch vessel along the guide wire under the action of the stent delivery device, the stent will be locked at the opening of the branch vessel under the action of the positioning guide wire that passes through the limiting hole on the restraint membrane. So that the stent can be accurately positioned in the axial direction.
  • the circumferential direction of the limiting hole with respect to the stent is also determined. Therefore, the stent's circumferential direction can also be accurately positioned, so that The stent can be accurately implanted into the branch blood vessel. At this time, the stent can be released by releasing the restraint film. This can make the stent accurately fit the blood vessel wall, such as its opening.
  • This implantation system has a simple structure and is easy to operate. Simple and easy.
  • FIG. 1 is a schematic structural diagram of a stent precision implantation system for branch blood vessels during an implantation process according to an exemplary embodiment of the present disclosure
  • FIG. 2 is an enlarged structural diagram of a portion A in FIG. 1; FIG.
  • FIG. 3 is a schematic structural diagram of a stent with an oblique incision implanted in a branch vessel according to an exemplary embodiment of the present disclosure.
  • orientation words such as “inside and outside” generally refer to the inside and outside of the contour of the corresponding object, and “front and back” are usually along the blood vessel with the stent and related components, unless otherwise stated.
  • the implantation direction is defined on the basis that the corresponding component enters the blood vessel forward and exits the blood vessel backward.
  • the branch blood vessel in a vascular stent implantation operation, a branch blood vessel having a branch is often encountered, that is, the branch blood vessel includes a main blood vessel 1 and a branch blood vessel 2 communicating with the main blood vessel 1, that is, the branch blood vessel 2 is connected to On the side wall of the main blood vessel 1, because the connection area between the branch blood vessel 2 and the main blood vessel 1 has an arc-shaped transition, the size of the opening of the branch blood vessel 2 close to the main blood vessel 1 presents an outwardly expanding flared structure.
  • Implantation of the existing straight-type stent will prevent the stent from perfectly conforming to the blood vessel wall at the opening of the branch vessel 2, which will cause the stent and blood vessel wall in this area to form a thrombus and cause vascular disease. Therefore, a trumpet-shaped opening stent needs to be used, and the opening of the stent is formed into a trumpet shape that is open outward, so that it can fit well to the opening transition area of the branch blood vessel 2 of the branch blood vessel.
  • the present disclosure provides a stent precision implantation system for branching blood vessels, which can effectively ensure accurate positioning of the axial position and the circumferential direction of the stent.
  • the stent 6 to be implanted includes a main body portion 61 and an opening portion 62 located at the rear end of the main body portion 61.
  • the main body portion 61 is formed into a straight tube structure to accommodate the corresponding branch.
  • the blood vessel wall of the blood vessel, and the opening portion 62 is formed as a trumpet-shaped structure that opens outward to accommodate the opening of the branch vessel.
  • the opening portion 62 is formed as an arc-shaped transition structure that opens outward to accommodate the shape of the branch vessel opening.
  • the specific structure of the trumpet-shaped structure needs to depend on the structure of the opening of the implanted branch vessel 2 and falls within the protection scope of the present disclosure for various deformations.
  • the opening portion 62 of the bracket 6 may be formed as a beveled cut structure, that is, the opening plane of the opening portion 62 is opposite to The axis of the main body portion 61 is provided obliquely. In this way, the oblique incision stent can accurately adapt to the opening of the branch blood vessel 2 which is disposed obliquely, and does not protrude into the main blood vessel 1 and cause the main blood vessel 1 to be blocked as shown by the dotted line.
  • the reason why such an oblique incision stent can be used is also due to the accurate stent implantation system provided in the present disclosure, which can achieve precise positioning of the stent in the circumferential direction and the axial position. This makes the present disclosure more suitable for stent implantation of branch blood vessels.
  • the opening plane of the trumpet-shaped opening portion 62 as shown in FIG. 1 can also be formed into a chamfered form. For such an embodiment, it should also fall within the protection scope of the present disclosure.
  • the present disclosure provides a precision implantation system of a branch blood vessel, which includes a stent delivery for releasably receiving the stent 6 and transporting the stent 6.
  • a stent delivery for releasably receiving the stent 6 and transporting the stent 6.
  • Device guide wire 4 extending from main blood vessel 1 to branch blood vessel 2, and positioning guide wire 5 extending along main blood vessel 1, the stent delivery device is movably sheathed outside the guide wire 4, and the stent delivery device includes a releasable
  • the restraint film 3 is covered on the outer periphery of the stent 6.
  • the restraint film 3 is provided with a limiting hole 7.
  • the positioning guide wire 5 can slide through the limiting hole 7 to position the stent 6 in the axial and circumferential directions. Specifically, on the basis of the guide wire 4, a positioning guide wire 5 is added to realize the positioning of the stent 6 in the axial position and the circumferential direction through the positioning guide wire 5. After the main blood vessel 1 is introduced, it will be drawn through different paths. As shown in FIG. 1, the guide wire 4 extends from the main blood vessel 1 to the branch blood vessel 2, and the positioning guide wire 5 extends along the main blood vessel 1 and is implanted.
  • the access system also includes a limiting hole 7 fixedly disposed relative to the stent 6 and for the positioning guide wire 5 to slidably pass through.
  • the restraint membrane 3 can be released and tightly attached to the blood vessel wall after being released due to its elastic effect, and remain on the vessel wall.
  • the body or the tethering membrane 3 can also be withdrawn from the body after the stent 6 is released.
  • the material of the tethering membrane 3 is a material that can be left in the blood vessel after the operation, for example, a compound prepared from polytetrafluoroethylene, polyurethane and the like commonly used in the field will not affect the stent 6 Normal use.
  • the stent 6 will be locked in the opening of the branch vessel 2 under the action of the positioning guide wire 5 passing through the limiting hole 7 So that the stent 6 can be accurately positioned in the axial direction.
  • the circumferential direction of the limiting hole 7 relative to the stent 6 is also determined, so the circumferential direction of the stent 6 can be made. It is also precisely positioned, so that the stent 6 can be accurately implanted into the branch vessel 2. At this time, the stent 6 can be released by releasing the restraint membrane 3, so that the stent 6 can be accurately fitted to the blood vessel wall, such as the opening portion thereof.
  • This implant system has a simple structure and is easy to operate.
  • the limiting hole 7 is provided on the restraint film 3.
  • the restraint film 3 can be formed integrally with the bracket 6 at all times, and the limiting hole 7 is relatively fixed relative to the bracket 6.
  • the positioning guide wire 5 of the limiting hole 7 restricts the restraint membrane 3 from being positioned in the axial direction and the circumferential direction, thereby achieving accurate implantation of the stent 6.
  • the positioning guide wire 5 can be drawn out first, so that the restraint membrane 3 can drive the limiting hole 7 to be gradually separated from the stent 6 and pulled out of the body in the process of releasing the stent 6.
  • the limiting hole 7 provided on the restraint film 3 may be a hole formed when the positioning guide wire 5 itself directly passes through the restraint film 3.
  • the limit hole 7 may also be a limit hole connected to the restraint film 3. The loop is formed so that it can be used to restrain the positioning guide wire 5. It should be noted that the size of the stop ring formed on the restraint membrane 3 is very small, and it can be directly implanted into the human body with the restraint membrane 3 without affecting the function of the stent 6.
  • the stent 6 used in the present disclosure is a self-expanding stent, that is, after the stent 6 is released, it will automatically spring open.
  • the stent 6 will be released when the restraint membrane 3 is released.
  • the stent delivery device includes a guide core 8 that can be moved along the guide wire 4. When the restraint membrane 3 remains in the body at all times, the guide core 8 is pressed against the inside of the stent 6 in the tightened state.
  • the stent 6 is released by releasing the tethering membrane 3, and the tethering membrane 3 is attached to the blood vessel wall.
  • the guide core 8 can be detached from the stent 6 and then withdrawn from the body.
  • the guide core 8 is connected to the tethering membrane 3, and the tethering membrane 3 can be pulled away from the stent 6 through the guide core 8 while releasing the tethering membrane 3, and then pulled out of the body while the stent 6 It is then released to fit on the vessel wall.
  • the guide core 8 is a hollow structure so as to be sheathed outside the guide wire 4 and can move along the guide wire 4.
  • the guide core 8 can be controlled by extending backward to the outside of the body, for example, a control device connected to the outside of the body.
  • the restraint film 3 may be sewn by a suture 31 to tighten itself to cover the stent 6 and tighten accordingly.
  • the suture thread 31 is easy to detach, and can be detached by pulling one end of the suture thread 31.
  • the suture 31 on the tethering film 3 includes an extension portion that can be extended outside the body, so that the extension portion can be pulled when the tethering film 3 is released.
  • a protective tube 311 is provided on the outside of the extension to protect the extension and extend to the outside of the body. This can avoid accidentally pulling the suture 31 during the implantation of the stent and affecting the operation.
  • the structure of the implantation system provided by the present disclosure is described above, and the implantation method of the implantation system provided by the present disclosure in mounting the stent 6 to the branch vessel 2 is described in detail below.
  • the guide wire 4 is introduced from the main blood vessel 1 to the branch blood vessel 2, the guide core 8 is passed through the inside of the stent 6 and the stent 6 is compressed and pressed against the guide core 8 so that the stent 6 can communicate with the guide.
  • the core 8 moves synchronously, and then the compressed stent 6 is stored in the restraint membrane 3, and then the restraint membrane 3 is sewn to tighten it, and an extended suture 31 is formed at the suture interface.
  • the guide wire 5 is positioned After passing through the limiting hole 7, it extends along the main blood vessel.
  • the step of introducing the stent 6 into the branch vessel 2 is performed.
  • the control device is operated to control the guide core 8 to move forward along the guide wire 4 in the blood vessel.
  • the guide core 8 drives the stent 6 and the tethering membrane 3 to ensure the stent. 6 Move into branch vessel 2.
  • the positioning guide wire 5 is tightened and the stent 6 is further moved forward, so as to achieve the axial and circumferential limitation of the positioning guide wire 5 on the stent 6 That is, the opening portion 62 can be aligned with the opening transition area of the branch vessel 2, so that the stent 6 can be accurately positioned.
  • the release steps of the stent 6 are described below.
  • the restraint membrane 3 will expand due to the elastic pressure of the stent 6, that is, release from the stent 6, and the stent 6 will be released and bound at this time.
  • the membrane 3 will fit on the wall of the blood vessel under the expansion of the stent 6 and stay in the body with the stent 6.
  • the exit step of the implantation system is performed. First, the suture 31 and the protective tube 311 are operated to be pulled out from the body. Since the stent 6 has been completely attached to the blood vessel wall, the guide core is operated.
  • the positioning guide wire 5 needs to be pulled out of the body first, so that the tethering membrane 3 is not removed from the stent 6 during the release step. Will be restricted. Variations on such steps fall within the scope of the present disclosure.
  • the tethering membrane 3 can be connected to the guide core 8 in the preparation step, so that during the release process, the guide core 8 can drive the tethering membrane 3 to pull out of the stent 6.
  • the tethering membrane 3 can be controlled by the control device on the outside of the body to withdraw the body separately.
  • the blood vessel implantation system and method provided by the present disclosure can realize the precise implantation of the stent 6 with a flared opening or a beveled opening at a branched opening of a branch blood vessel, and has high practicality and promotion value.
  • the branched blood vessel implantation system provided by the present disclosure can be used for other shapes of stents, such as the implantation of ordinary straight-type stents, in addition to stents with flared openings.
  • the stent delivery device provided by the present disclosure can be used for stent implantation of blood vessels in other positions in addition to the field of implantation of branch blood vessels. Without departing from the concept of the present disclosure, for such application objects and fields All the deformations fall within the protection scope of the present disclosure.

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Abstract

一种分支血管的支架精准植入系统，分支血管包括相互连通的主血管（1）和与主血管（1）连通的支血管（2），支架精准植入系统包括可释放地收纳支架（6）并输送该支架（6）的支架输送装置、从主血管（1）延伸到支血管（2）的导引导丝（4）、以及沿主血管（1）延伸的定位导丝（5），支架输送装置可移动地套设在导引导丝（4）外，支架输送装置包括可解脱地包覆于支架（6）的外周的束缚膜（3），束缚膜（3）上或支架上（6）设置有限位孔（7），定位导丝（5）可滑动地穿过限位孔（7），以能够在轴向和周向定位支架（6）。支架（6）在穿过限位孔（7）的定位导丝（5）的作用下，会卡止在支血管（2）的开口处，使得支架（6）能够精准贴合于开口部分，可以通过撑开束缚膜（3）或将束缚膜（3）移出体外的方式释放支架（6），此种植入系统结构简单，操作起来简单易行。

Description

分支血管的支架精准植入系统 技术领域
本公开涉及血管的支架植入领域，具体地，涉及一种分支血管的支架精准植入系统。
背景技术
血管狭窄、闭塞是一种高致残率和高死亡率的疾病，针对这种疾病，在血管内植入支架是主要的治疗方法之一。该技术是将支架输送到病变位置，用于径向支撑发生堵塞的血管。其中，随植入位置和治疗病种的不同血管支架的种类、结构和植入方式也各不相同。目前，广泛使用的支架包括裸支架、涂层支架等，支架的解脱方式可分为球扩方式和自膨方式。而植入方式多为将压缩后的支架通过导丝引导至植入位置后再解脱。其中，球扩解脱方式为通过向位于预置在支架内部的球状气囊中充液(气)以将支架扩开后撤出，自膨解脱方式为通过将收纳被压缩支架的导鞘撤离后，通过支架自身的弹性结构弹开。其中无论是球扩还是自膨方式的植入，都存在支架的准确定位和适应多种血管结构的问题。例如在具有支血管的分支血管结构的开口部分，不仅血管支架本身的结构需要特殊设计，而且植入方式也需要对应地改善才能够满足在此类位置精确植入支架的目的。这是由于支血管和主血管的连接部分即开口部分的结构具有弧形过渡结构并且血管的周向结构也不同，因此需要一种可以精确植入分支血管的支架及植入系统，相关技术中用于此种血管支架的植入系统通常包括输送支架的导鞘、导芯及顶芯，这种结构植入支架时需要的步骤繁多，操作起来复杂麻烦。
发明内容
本公开的目的是提供一种分支血管的支架精准植入系统，该支架精准植入系统能够使得支架精确地植入在分支血管中，而且结构简单，易于操作。
为了实现上述目的，本公开提供一种分支血管的支架精准植入系统，所述分支血管包括相互连通的主血管和与所述主血管连通的支血管，所述支架精准植入系统包括可释放地收纳支架并输送该支架的支架输送装置、从所述主血管延伸到所述支血管的导引导丝、以及沿所述主血管延伸的定位导丝，所述支架输送装置可移动地套设在所述导引导丝外，所述支架输送装置包括可解脱地包覆于所述支架的外周的束缚膜，所述束缚膜上或所述支架上设置有限位孔，所述定位导丝可滑动地穿过所述限位孔，以能够在轴向和周向定位所述支架。
可选地，所述限位孔由连接在所述束缚膜上的限位环形成。
可选地，所述支架具有主体部和位于该主体部后端的开口部，所述主体部形成为直筒结构，所述开口部形成为喇叭形结构。
可选地，所述支架具有主体部和位于该主体部后端的开口部，所述主体部形成为直筒结构，所述开口部的开口平面相对于所述主体部的轴线倾斜设置。
可选地，所述支架输送装置包括可沿所述导引导丝移动的导芯，所述限位孔设置在所述束缚膜上，所述导芯顶紧在收紧状态的所述支架内部。
可选地，所述限位孔形成在所述束缚膜上相对应所述开口部的位置。
可选地，所述支架输送装置包括可沿所述导引导丝移动的导芯，所述导芯与所述束缚膜连接。
可选地，所述束缚膜通过缝合线缝合而成，以包覆所述支架。
可选地，所述缝合线包括能够延伸至体外的延伸部。
可选地，所述延伸部的外部套设有延伸至体外的保护管。
通过上述技术方案，支架在支架输送装置的作用下沿着导引导丝进入支 血管后，支架在穿过束缚膜上的限位孔的定位导丝的作用下，会卡止在支血管的开口处，从而能够在轴向上精准定位支架，同样，定位导丝在拉紧后，限位孔相对于支架的周向方向同样是确定的，因此可以使得支架的周向方向也精确定位，从而使支架能够精准地植入支血管中，此时可以通过解脱束缚膜的方式而释放支架，这样可以使得支架能够精准贴合于血管壁，例如其开口部分，此种植入系统结构简单，操作起来简单易行。
本公开的其他特征和优点将在随后的具体实施方式部分予以详细说明。
附图说明
附图是用来提供对本公开的进一步理解，并且构成说明书的一部分，与下面的具体实施方式一起用于解释本公开，但并不构成对本公开的限制。在附图中：
图1是本公开一示例性实施方式提供的分支血管的支架精准植入系统在植入过程中的结构示意图；
图2是图1中A部的放大结构示意图；
图3是本公开一示例性实施方式提供的具有斜切口的支架植入在分支血管中的结构示意图。
附图标记说明
1      主血管            2        支血管
3      束缚膜            31       缝合线
311    保护管            4        导引导丝
5      定位导丝          6        支架
61     主体部            62       开口部
7      限位孔            8        导芯
具体实施方式
以下结合附图对本公开的具体实施方式进行详细说明。应当理解的是，此处所描述的具体实施方式仅用于说明和解释本公开，并不用于限制本公开。
在本公开中，在未作相反说明的情况下，使用的方位词如“内、外”通常是指相应物体轮廓的内和外，“前、后”则通常是以支架及相关部件沿血管的植入方向为基础定义的，即，相应部件向前进入血管，向后退出血管。这些方位词只用于说明本公开，并不用于限制本公开。
如图1所示，在血管支架植入手术中，常常会遇到具有分支的分支血管，即该分支血管包括主血管1以及与该主血管1连通的支血管2，即支血管2连接在主血管1的侧壁上，由于支血管2和主血管1之间的连接区域具有弧形过渡，使得支血管2的接近主血管1的开口的尺寸呈现向外扩展的喇叭形结构，这样如果植入现有的直筒型支架，将使得支架在支血管2开口处不能完好地贴合于血管壁，这样将使得该区域的支架和血管壁形成血栓从而造成血管病变。因此，需要使用一种喇叭形开口支架，该支架的开口形成为向外开放的喇叭形，从而能够良好地贴合于分支血管的支血管2的开口过渡区域。另外，当支血管2与主血管1之间具有倾斜角度时，如果仍使用直筒型支架，在支架定位后，支架的后端开口将部分地伸入主血管1中，这样会造成对主血管1的堵塞，因此需要一种具有斜切口的支架以能够适应倾斜的支血管2。然而，无论是喇叭形或斜切口结构的开口，都将面临需要将支架的周向方向准确定位的问题，否则将不能适应支血管2的开口在周向方向上的形状，造成支架效果差。因此，在植入过程中，对支架的周向方向和轴向位置的控制均具有较高要求。据此，本公开提供一种用于分支血管的支架精准植入系统，能够有效保证支架的轴向位置和周向方向的精准定位。
其中，如图1和图2所示，在一种实施方式中，需要植入的支架6包括主体部61和位于主体部61后端的开口部62，主体部61形成为直筒结构以适应相应分支血管的血管壁，而开口部62形成为向外开放的喇叭形结构以适应分支血管的开口，具体地，开口部62形成为向外开放的弧形过渡结构，以适应分支血管开口的形状。其中该喇叭形结构的具体结构需要取决于所植入支血管2开口的结构，对于各种变形均落在本公开的保护范围中。
另外，除这种具有喇叭形开口结构的支架外，如图3所示，在另一中实施方式中，支架6的开口部62可以形成为斜切口结构，即，开口部62的开口平面相对于主体部61的轴线倾斜设置。这样，该斜切口式支架可以精确适应倾斜设置的支血管2的开口，而不会如虚线所示的那样突入主血管1中造成主血管1堵塞。而能够使用这种斜切口支架的原因，同样得益于本公开提供的支架精确植入系统能够实现支架在周向方向和轴向位置的精确定位。从而使得本公开更加适用于分支血管的支架植入。其中还可以将如图1所示的喇叭形的开口部62的开口平面也形成为斜切形式，对于此类实施方式也应落在本公开的保护范围中。
如图1所示，为了保证能够将该支架6精准地植入到分支血管中，本公开提供一种分支血管的精准植入系统，包括可释放地收纳支架6并输送该支架6的支架输送装置、从主血管1延伸到支血管2的导引导丝4、以及沿主血管1延伸的定位导丝5，支架输送装置可移动地套设在导引导丝4外，支架输送装置包括可解脱地包覆于支架6的外周的束缚膜3，束缚膜3上设置有限位孔7，定位导丝5可滑动地穿过限位孔7，以能够在轴向和周向定位支架6。具体地说，在导引导丝4的基础上，增加定位导丝5，以通过定位导丝5实现对支架6在轴向位置和周向方向的定位，导引导丝4和定位导丝5在引入主血管1后将穿过不同的路径引出，如图1所示，导引导丝4从主血管1引入后延伸至支血管2，而定位导丝5则一直沿主血管1延伸，并且 植入系统还包括相对于支架6固定设置并供定位导丝5可滑动地穿过的限位孔7，束缚膜3由于本身的弹性作用可以通过释放后解脱紧贴在血管壁上，并且留在体内，或者束缚膜3也可以在支架6释放后抽出体外。其中需要说明的是，束缚膜3的材料为术后可留于血管中的材质，例如本领域内常用的由聚四氟乙烯、聚氨基甲酸乙酯等制备的化合物，不会影响支架6的正常使用。这样，支架6在支架输送装置的作用下沿着导引导丝4进入支血管2后，支架6在穿过限位孔7的定位导丝5的作用下，会卡止在支血管2的开口处，从而能够在轴向上精准定位支架6，同样，定位导丝5在拉紧后，限位孔7相对于支架6的周向方向同样是确定的，因此可以使得支架6的周向方向也精确定位，从而使支架6能够精准地植入支血管2中，此时可以通过解脱束缚膜3的方式而释放支架6，这样可以使得支架6能够精准贴合于血管壁，例如其开口部分，此种植入系统结构简单，操作起来简单易行。
根据本公开的一个实施方式，如图2所示，限位孔7设置在束缚膜3上，此时束缚膜3可以始终与支架6形成为一体，限位孔7相对于支架6处于相对固定位置，其中，限位孔7可以设置在束缚膜3上与支架开口部62相对应的位置，这样，当支架6释放后，束缚膜3会由于支架6的膨胀的弹性作用展开，而穿过限位孔7的定位导丝5会限制束缚膜3在轴向与周向定位，从而实现支架6的精准植入，此时束缚膜3会在支架6释放后留在体内。在另一实施方式中，可以先抽出定位导丝5，这样束缚膜3可以带动限位孔7在释放支架6的过程中逐渐与支架6分离抽出体外。
其中，设置在束缚膜3上的限位孔7可以为定位导丝5自身直接穿过束缚膜3时形成的孔，本公开中，限位孔7还可以由连接在束缚膜3上的限位环形成，以能够用于约束定位导丝5。需要说明的是，形成在束缚膜3上的限位环的尺寸很小，可以直接随束缚膜3植入人体中而不会影响支架6的功能。
本公开中，为了更好地实现对具有喇叭形开口或斜切口的支架6的输送，本公开采用的支架6为自膨支架，即在释放支架6后，其会自动弹开，具体地，本公开中，支架6会随着束缚膜3的释放而释放弹开。具体地，如图1所示，支架输送装置包括可沿导引导丝4移动的导芯8，当束缚膜3始终留在体内时，导芯8顶紧在收紧状态的支架6内部，通过解脱束缚膜3来释放支架6，使束缚膜3贴合在血管壁上，导芯8可以在支架6释放后与支架6脱离，进而抽出体外。当束缚膜3在支架6释放后抽出体外时，导芯8与束缚膜3连接，可以边释放束缚膜3边通过导芯8带动束缚膜3与支架6抽离，进而抽出体外，同时支架6随之释放贴合在血管壁上。其中，导芯8为空心结构以套在导引导丝4外并能够沿导引导丝4移动，导芯8可以以向后延伸到体外的方式得到操控，例如连接体外端的控制装置。
本公开中，如图1-图2所示，束缚膜3可以通过缝合线31缝合而成，使其自身收紧，以包覆支架6随之收紧。缝合线31为易拆型，通过拉扯缝合线31的一端，即可拆开。具体地，束缚膜3上的缝合线31包括能够延伸至体外的延伸部，这样，在释放束缚膜3时拉扯延伸部即可。
为了保证操作时稳定，延伸部的外部可以套设有保护延伸部并延伸至体外的保护管311，这样可以避免在植入支架过程中不小心拉拽缝合线31，影响操作。
上述介绍了本公开提供的植入系统的结构，下面详细介绍本公开提供的植入系统在将支架6安装到支血管2的植入方法。
首先，在准备步骤中，将导引导丝4从主血管1引入延伸到支血管2，将导芯8穿过支架6内部并将支架6压缩顶紧导芯8，以使支架6能与导芯8同步运动，再将压缩后的支架6收纳在束缚膜3中，然后对束缚膜3自身缝合使其收紧，并在缝合的接口处形成延伸的缝合线31，最后将定位导丝5穿过限位孔7后沿主血管延伸。
然后，进行将支架6引入支血管2的步骤，首先，操作控制装置以控制导芯8沿导引导丝4在血管内向前移动，通过导芯8带动支架6与束缚膜3移动，以保证支架6向支血管2中移入。当主体部61的后端位置到达支血管2的入口时，拉紧定位导丝5并挡住支架6继续向前运动，从而实现定位导丝5对支架6的轴向限位和周向限位，即，使得开口部62能够与支血管2的开口过渡区域对齐，使支架6实现精准定位。
下面介绍支架6的释放步骤，通过操作控制装置向后拉拽缝合线31，束缚膜3会因为支架6的弹性压力而扩展，即与支架解脱6，此时支架6会随之得到释放，束缚膜3会在支架6的膨胀作用下贴合在血管壁上，并随支架6留在体内。最后，待束缚膜3完全贴合于血管壁后，进行植入系统的退出步骤，首先操作缝合线31及保护管311向后抽出体外，由于支架6已经完全贴合于血管壁，操作导芯8沿导引导丝4从扩张后的支架6内部向后抽出体外，最后抽出导引导丝4和定位导丝5，这样，通过定位导丝5可一直对释放过程中的支架6进行定位。
需要说明的是，在上述过程中，如果束缚膜3需要在支架6释放后抽出体外，在释放步骤，需要首先将定位导丝5抽出体外，使束缚膜3在与支架6脱离的过程中不会受到限制。对于这种步骤上的变形方式均落在本公开的保护范围内。其中，当束缚膜3需要抽出体外时，可以在准备步骤中将束缚膜3与导芯8连接，这样，在释放过程中，导芯8可以带动束缚膜3抽离支架6，其他实施方式中，也可以通过体外端的控制装置单独操控束缚膜3抽出体外。
综上，本公开提供的血管的植入系统和方法能够实现具有喇叭形开口或斜切形开口的支架6在分支血管的分叉开口处的精确植入，具有较高的实用性和推广价值。另外，本公开提供的分支血管的植入系统除用于具有喇叭形开口的支架外，还可以用于其他形状的支架，例如普通直筒型支架的植入。 此外，本公开提供的支架输送装置除用于在分支血管的植入领域中，还可以用于其他位置血管的支架植入，在不脱离本公开构思的情况下，对于这种应用对象和领域的变形均落在本公开的保护范围中。
以上结合附图详细描述了本公开的优选实施方式，但是，本公开并不限于上述实施方式中的具体细节，在本公开的技术构思范围内，可以对本公开的技术方案进行多种简单变型，这些简单变型均属于本公开的保护范围。
另外需要说明的是，在上述具体实施方式中所描述的各个具体技术特征，在不矛盾的情况下，可以通过任何合适的方式进行组合，为了避免不必要的重复，本公开对各种可能的组合方式不再另行说明。
此外，本公开的各种不同的实施方式之间也可以进行任意组合，只要其不违背本公开的思想，其同样应当视为本公开所公开的内容。

Claims (10)

  1. 一种分支血管的支架精准植入系统，所述分支血管包括相互连通的主血管(1)和与所述主血管(1)连通的支血管(2)，其特征在于，所述支架精准植入系统包括可释放地收纳支架(6)并输送该支架(6)的支架输送装置、从所述主血管(1)延伸到所述支血管(2)的导引导丝(4)、以及沿所述主血管(1)延伸的定位导丝(5)，所述支架输送装置可移动地套设在所述导引导丝(4)外，所述支架输送装置包括可解脱地包覆于所述支架(6)的外周的束缚膜(3)，所述束缚膜(3)上设置有限位孔(7)，所述定位导丝(5)可滑动地穿过所述限位孔(7)，以能够在轴向和周向定位所述支架(6)。
  2. 根据权利要求1所述的支架精准植入系统，其特征在于，所述限位孔(7)由连接在所述束缚膜(3)上的限位环形成。
  3. 根据权利要求1所述的支架精准植入系统，其特征在于，所述支架(6)具有主体部(61)和位于该主体部(61)后端的开口部(62)，所述主体部(61)形成为直筒结构，所述开口部(62)形成为喇叭形结构。
  4. 根据权利要求1所述的支架精准植入系统，其特征在于，所述支架(6)具有主体部(61)和位于该主体部(61)后端的开口部 (62)，所述主体部(61)形成为直筒结构，所述开口部(62)的开口平面相对于所述主体部(61)的轴线倾斜设置。
  5. 根据权利要求3或4所述的支架精准植入系统，其特征在于，所述支架输送装置包括可沿所述导引导丝(4)移动的导芯(8)，所述导芯(8)顶紧在收紧状态的所述支架(6)内部。
  6. 根据权利要求5所述的支架精准植入系统，其特征在于，所述限位孔(7)形成在所述束缚膜(3)上相对应所述开口部(62)的位置。
  7. 根据权利要求3或4所述的支架精准植入系统，其特征在于，所述支架输送装置包括可沿所述导引导丝(4)移动的导芯(8)，所述导芯(8)与所述束缚膜(3)连接。
  8. 根据权利要求1所述的支架精准植入系统，其特征在于，所述束缚膜(3)通过缝合线(31)缝合而成，以包覆所述支架(6)。
  9. 根据权利要求8所述的支架精准植入系统，其特征在于，所述缝合线(31)包括能够延伸至体外的延伸部。
  10. 根据权利要求9所述的支架精准植入系统，其特征在于，所 述延伸部的外部套设有延伸至体外的保护管(311)。
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