CN203539840U - Adjustable bending sheath canal and conveying system with same - Google Patents

Adjustable bending sheath canal and conveying system with same Download PDF

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Publication number
CN203539840U
CN203539840U CN201320549231.9U CN201320549231U CN203539840U CN 203539840 U CN203539840 U CN 203539840U CN 201320549231 U CN201320549231 U CN 201320549231U CN 203539840 U CN203539840 U CN 203539840U
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China
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sheath
tubular body
canal
adjustable
distal end
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CN201320549231.9U
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Chinese (zh)
Inventor
曾敏
张志飞
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杭州启明医疗器械有限公司
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Priority to CN 201310397312 priority Critical patent/CN103446655A/en
Priority to CN201320549231.9U priority patent/CN203539840U/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart 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
    • A61F2/2427Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436Deployment by retracting a sheath
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238Type of minimally invasive operation
    • A61B2017/00243Type of minimally invasive operation cardiac
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003Steerable
    • A61B2017/00318Steering mechanisms
    • A61B2017/00323Cables or rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/00336Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means with a protective sleeve, e.g. retractable or slidable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M2025/0062Catheters; Hollow probes characterised by structural features having features to improve the sliding of one part within another by using lubricants or surfaces with low friction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/005Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids

Abstract

The utility model discloses an adjustable bending sheath canal and a conveying system with the same. The adjustable bending sheath canal comprises a canal body, wherein the canal body is provided with a far end and a near end, a reinforcing rib and a traction fibre are arranged on the canal wall of the canal body along an axial direction, the far end of the traction fibre is fixed at the far end of the canal body, and the near end of the traction fibre extends out of the canal body to be connected with an operation system. The conveying system comprises the adjustable bending sheath canal, a sheath core arranged in the sheath canal, and the operation handle fixed with the near ends of the adjustable bending sheath canal and the sheath core, and the near end of the traction fibre is fixed on the operation handle. According to the adjustable bending sheath canal disclosed by the utility model, an adjustment for the far-end direction of the sheath canal is contributed, the controllability of the far-end bending direction of the sheath canal is improved, and the movement of the far end of the sheath canal to diseased regions can be easily controlled.

Description

可调弯鞘管及具有该可调弯鞘管的输送系统技术领域 Adjustable bending sheath and having a delivery system Field of the adjustable bending sheath

[0001] 本实用新型属于医疗器械技术领域,尤其涉及一种可调弯鞘管及具有该可调弯鞘管的输送系统。 [0001] The present invention belongs to the technical field of medical devices, and particularly to an adjustable bending sheath and the delivery system having an adjustable bend sheath.

背景技术 Background technique

[0002] 介入手术对人体造成的创伤小,侵害性少,是近些年迅速兴起并推广的医疗技术,通常需要借助介入型诊疗鞘管(如输送鞘管、导引鞘管等),在患者体内的病变位置与外界操作端之间建立通道,以导入诊疗器械、药物、植入器械等至病变部位。 [0002] interventional procedures on the human body caused by small trauma, less invasive, and promote rapid rise in recent years of medical technology often needs the intervention clinics sheath type (such as delivery sheath introducer sheath, etc.), in lesion position outside the patient between the operating end and the establishment of the channel, to introduce medical instruments, drugs, and other implantable devices to the lesion. 介入型诊疗鞘管具有远端和近端,远端可进入人体的脉管系统,近端与操作手柄相连接,在使用时,通常是预先建立导丝轨道,将鞘管的远端或连通其他辅助器械穿刺进入血管内,医师通过操作手柄控制鞘管的远端沿着事先建立好的导丝轨道行进至病变部位释放药物、器械等。 Interventional treatment sheath type having a distal end and a proximal end, a distal end can enter the body's vasculature and a proximal end connected to the operating handle, when used, it is usually pre-established track guidewire, the distal end of the sheath or communication other auxiliary equipment puncture into the blood vessels, the physician to control the distal end of the sheath by operating the handle proceeds to release the drug lesion, the instrument along a pre-established guidewire track or the like.

[0003] 基于人体脉管系统迂回曲折的特性以及远距离操作的考虑,鞘管通常应具备足够的轴向与径向支撑力以及良好的顺应性,在达到病变部位以前,通过医师的推送,鞘管自身具备的顺应性能够使鞘管的远端在沿着导丝轨道行进的过程中,自适应的调整弯曲方向以顺应人体的脉络。 [0003] System Based tortuous body vessel and considering the characteristics of the remote operation, the sheath typically should have sufficient axial and radial strength and good compliance, before reaches the lesion, the physician by pushing, compliant sheath itself can be provided in the distal end of the sheath along the guide wire during traveling track, adjusted adaptively to conform to the bending direction of the human context. 由于血管内血流的影响,鞘管通常是沿着血管壁前进,在前期,这对鞘管的行进路线并无太大的影响,但是在药物、器械释放时,需要鞘管的远端对准病变部位,显然的,此时必须对鞘管的远端的方向进行调节和控制,使其移动至目标位置。 Due to the influence of the blood flow, the sheath is typically proceeds along the vessel wall, the distal end, which influence the pre-travel route of the sheath is not much, but when the drug release device, the need for the sheath quasi lesions, it is evident, and must now be adjusted to control the direction of the distal end of the sheath, moved to a target position.

[0004] 以心脏瓣膜置换术为例,人体的心脏瓣膜位于血管的中央位置,当需要对心脏瓣膜置换时,鞘管的远端需到达瓣膜的中心,再将携带的心脏瓣膜置换装置释放,使心脏瓣膜置换装置代替自身的瓣膜行驶功能,由于鞘管是沿着血管壁前进的,因此在靠近病变位点时,就需要调整鞘管远端的方向,使其朝向瓣膜的中心移动,如主动脉瓣的直径约为26_,而该处血管的直径显然大于主动脉瓣的直径,而通常鞘管远端的直径为7mm左右,那么至少应使鞘管的远端在血管的直径方向移动9_左右。 [0004] In an example heart valve replacement surgery, a blood vessel located in a central position of the human heart valve, when the need for cardiac valve replacement, the distal end of sheath required to reach the center of the valve, heart valve replacement device then carried release, heart valve replacement valve driving means in place of its own functions, since the sheath is advancing along the vascular wall, thus when approaching the lesion site, it is necessary to adjust the direction of the distal end of the sheath, so that it faces the center of the valve movement, such as aortic diameter of about 26_, and where the vessel is clearly greater than the diameter of the diameter of the aortic valve, the distal end of the sheath generally having a diameter of approximately 7mm, then at least the distal end of the sheath should be moved in the diameter direction of the vessel 9_ around.

[0005] 一种解决办法是按照人体血管分布形状或者人体结构对导管的远端进行定形加工,结合不同的形状、结构定制不同形状的导管来满足在迂回的血管内到达病变部位的需求。 [0005] One solution is distributed in the blood vessels or the shape of the anatomy of the distal end of the catheter as setting processing, a combination of different shapes, different shapes of the conduit structure customized to meet the needs in the lesion reaches the bypass vessel. 如美国专利US2003144657披露了一种导管组件,该导管组件使用带有预成形远端的外导管和带有预成形的内导管,内、外导管的相对转动和延伸提供了导管组件远端末端的可调整形状,以改进通过右心房的定位和用导管插入冠状窦。 U.S. Patent No. US2003144657 discloses a catheter assembly, the catheter assembly for use with an outer distal end of the catheter and the inner catheters with a preformed, inner, and outer conduit relative rotation is provided extending preformed distal tip of the catheter assembly adjustable shape, to improve the positioning of the right atrium and coronary sinus catheter insertion. 但是这并不能与个体化的生理解剖结构一一相适应,很容易影响手术结果。 But this can go on and adapt to the anatomy and physiology of the individual, it is easy to affect the surgical outcome.

[0006]目前,通常采用的解决方案是运用远端可调弯的鞘管,通常是有一根或多根牵引丝(也有称拉线),其远端固定于鞘管的远端,并一直延伸至鞘管近端,与鞘管近端手柄上的调节机构相连接,该牵引丝可在导管内滑动,以允许医生主动的改变导管曲率,将鞘管远端弯曲,引导其转弯行进到目标部位。 [0006] Currently, the solution generally employed is the use of an adjustable bend the distal end of the sheath, there is usually one or more pull wires (also called wire), which is fixed to the distal end of the distal end of the sheath, and extends to the proximal end of the sheath, connected to the adjusting mechanism on the sheath proximal handle, the pull wire is slidable within the catheter to allow the physician to actively change the curvature of the catheter, the distal end of the sheath is bent, it turns to travel to the guide target site.

[0007] 如公开号为CN102921089A的中国专利文献公开了一种用于介入治疗头部可控弯曲导管,多腔导管头部连接有主导管软头,多腔导管的尾部通过连接件与延长管连接,延长管外设有手柄,手柄内活动连接有手柄滑动装置,滑动装置与延长管挤压配合,滑动装置的上下两端延伸至手柄的壳体外,滑动装置的上下两侧分别连接有一根牵引丝,牵引丝的另一端穿过多腔导管和主导管软头上同侧的辅腔固定连接在主导管软头的头部,延长管另一端延伸到手柄外,连接有接头。 [0007] The Publication No. discloses a controlled deflection head intervention catheter, multi-lumen catheter head is connected to the main conduit soft head, tail multilumen catheter through the connecting member to the extension tube to the Chinese patent document CN102921089A connecting the extension pipe outside the handle, the handle is movably connected with a handle sliding means, the slide means and the extension tube extrusion with upper and lower ends to the slide means extends outside the handle housing, upper and lower sides of the slide are connected to a device pull wire, the other end of the pull wire through the multi-lumen catheter tube and the main and auxiliary soft head chamber fixedly connected to the same side of the head main conduit soft head, the other end of the extension pipe extending to the outer handle is connected to the joint. 在导管进入体内后,根据血管或者相关部位的结构,通过手柄控制牵引丝,牵引丝在受到手柄滑动装置的牵引力拉动导管远端的主导管软头,主导管软头受到牵引丝的拉力往回弯曲,从而实现方向的调节。 After the catheter into the body, the structure of the blood vessel or the relevant parts, controlled by a handle pull wire, the pull wire is pulled the distal end of the catheter main conduit soft head in traction by means of a sliding handle, soft head main conduit is pulled back tension wire bend, thereby achieving the adjustment direction.

[0008] 上述结构的导管(即鞘管)虽然允许医生主动改变导管曲率,实现了导管远端360°的任何角度弯曲,但在实际的手术操作中,由于鞘管远端角度的偏转,远端可弯曲的方向和目标位置之间配合需再次确认调整,而介入治疗的映像往往是平面投影映像,大大增加了了实际操作过程中对医生经验的依赖性。 [0008] The above-described configuration of the catheter (i.e., sheath) Although the catheter allows the physician to actively change of curvature, at any angle to achieve a 360 ° bend the distal end of the catheter, but in the actual surgical operation, since the deflection angle of the distal end of the sheath, distal be confirmed with a direction between the ends can be bent to adjust the target position again, the intervention of a projection image of the image plane is often greatly increased the dependence of the actual operation of the physician.

[0009] 因此,有必要提供一种鞘管,使医生容易的操纵方向以到达患者体内所希望的位置。 [0009] Accordingly, there is need to provide a sheath, so that the steering direction easily doctor for the patient reaches a desired position.

实用新型内容 SUMMARY

[0010] 本实用新型提供了一种可调弯鞘管,有利于鞘管远端方向的调节,提高了鞘管远端弯曲方向的可控性,能够容易的控制鞘管的远端向病变部位移动。 [0010] The present invention provides an adjustable bending sheath, facilitate adjustment of the sheath in the distal direction, the controllability of the bending direction of the distal end of the sheath, the distal end of the sheath can be easily controlled to the lesions moving parts.

[0011] 一种可调弯鞘管,包括管体,所述的管体具有远端和近端,所述管体的管壁内沿轴向设有加强筋和牵引丝,所述牵引丝的远端固定于所述管体的远端,所述牵引丝的近端延伸出管体用于与操作手柄相连。 [0011] An adjustable bend sheath comprising tubular body, said tubular body having a distal end and a proximal end, the inner wall of the tubular body is provided with a bead wire and axially pulling said traction wire fixed to the distal end of the distal end of the tubular body, the proximal end of the traction wire extending tubular body is connected to the operating handle.

[0012] 加强筋的设置定位了管体的折弯方向,在加强筋与管体轴线沿径向的连线方向上,鞘管不易折弯,当鞘管沿着导丝在血管中弯曲行进时,鞘管将自适应的以最易折弯的侧边完成弯曲过程,即在加强筋与管体轴线连线的垂线方向折弯,以顺应人体的脉管系统行进,当鞘管循迹穿越血管的弯曲部位后,鞘管会自适应的将易弯曲的方向朝向血管的中心,此时拉动牵引丝,即可使鞘管的远端向血管的中心弯曲、移动。 [0012] positioning the reinforcing rib is provided in the bent direction of the tube body in the axis of the body and the reinforcing rib in the radial direction of the wiring, easy bending sheath, when the sheath is bent to travel along the guide wire in a blood vessel when the sheath is bent to have the most adaptive side edge bending process is completed, i.e. the stiffener and the bend pipe connection axis perpendicular direction to conform to the vasculature of the body travels, when the sheath liable after the track portion through the bent blood vessel, the direction of the flexible sheath toward the center of the vessel will be adaptive, in which case the traction wire is pulled, the distal end of the sheath can be bent toward the center of the vessel, movement.

[0013] 加强筋的数目不宜过多,可设置一条或两条。 [0013] The number of the reinforcing ribs should not be too much, one or two may be provided.

[0014] 当加强筋为一条时,作为其中一种选择方式,所述的牵引丝为一根,所述的加强筋为一条。 [0014] When the bead is a time, which as an alternative embodiment, the dragline to a said bead is a. 一根牵引丝只能够实现单向调弯,当需要将鞘管向相背于牵引丝的方向调弯时,可将鞘管旋转约180°后,再拉动牵引丝。 A pull wire can only tune one-way bend, when the sheath to the desired direction opposite to the pull wire modulation bend, the sheath may be rotated about 180 °, and then pull the pull wire. 在设置牵引丝时,牵引丝应避免过度靠近加强筋,否则需对牵引丝施加较大的拉力才能够牵动鞘管的远端折弯,操作难度较大。 When the pull wire is provided, close to the pull wire to avoid excessive rib, or need traction filament for greater tension to be able to affect the distal end of the sheath is bent, the operation difficult. 优选的,在管体的任意截面上,加强筋与牵引丝的中心夹角为30〜150°。 Preferably, on a cross section of the tubular body, the central reinforcing rib angle with the traction wire is 30~150 °. 优选的,加强筋与牵引丝的中心夹角为80〜100°。 Preferably, the angle between the reinforcing ribs and the center of the pull wire is 80~100 °.

[0015] 本领域人员可以理解,上述管体的截面是指管体的径向截面,加强筋与牵引丝的中心夹角即是加强筋、牵引丝与截面中心的夹角。 [0015] Those skilled in the art will be appreciated, the cross section of the tubular body means is a radial section of the tubular body, the central reinforcing rib angle with the traction wire bead that is, the angle between the center of the section of the traction wire.

[0016] 作为另一种选择方式,所述的加强筋为一条,所述的牵引丝为两根,两根牵引丝分布于加强筋与管体轴线沿径向的连线的两侧。 [0016] As another alternative embodiment, the ribs of one of the traction wire as two, two pulling wires distributed in the stiffener and the axis of the tubular body radially connection sides. 设置两根牵引丝能够实现双向调弯。 Provided two pull wire can be adjusted bidirectional bending.

[0017] 加强筋为一条,牵引丝为两根时,在管体的任意截面上,加强筋与任意一根牵引丝的中心夹角为30〜150°。 [0017] The reinforcing rib is one, two traction wire is, on a cross section of the tubular body, and any reinforcing rib center an angle of pull wire 30~150 °. 优选的,加强筋与任意一根牵引丝的中心夹角为80〜100°。 Preferably, the angle between the reinforcing ribs and the center of any one pull wire is 80~100 °.

[0018] 一根加强筋可能导致鞘管在行进过程中不停的扭转,为克服该缺陷,加强筋可设置为两条,另外,两根加强筋对鞘管弯曲方向的限定也能更加严格。 [0018] a stiffener sheath may cause twisting stop during travel, to overcome this drawback, the reinforcing rib can be set to two, in addition, two of the reinforcing ribs defining a bending direction of the sheath can be more stringent .

[0019] 当加强筋为两条时,作为其中一种选择方式,所述的牵引丝为一根,所述的加强筋为两条。 [0019] When the reinforcing rib is two when, as an alternative embodiment in which, according to a dragline, two of the ribs.

[0020] 加强筋为两条,牵引丝为一根时,两条加强筋处在所述管体的轴心对侧,在管体的任意截面上,任意一根加强筋与牵引丝的中心夹角为30〜150°。 [0020] The two stiffeners, when the pull wire is one, two opposite sides of the rib in the axial center of the tubular body, on a cross section of the tubular body, any of a center reinforcing rib and traction wire angle of 30~150 °. 优选的,任意一根加强筋与牵引丝的中心夹角为80〜100°。 Preferably, the angle between the center of any of a reinforcing rib to the traction wire 80~100 °.

[0021] 作为另一种选择方式,所述的牵引丝为两根,所述的加强筋为两条,所述的牵引丝与加强筋在管体的周向上间隔分布。 [0021] As another alternative embodiment, the dragline is two, two of the ribs, the reinforcing ribs dragline and spaced in the circumferential direction of the tubular body.

[0022] 当牵引丝为两根,加强筋为两条时,两条加强筋处在所述管体的轴心对侧,在管体的任意截面上,任意一根加强筋与其中一根牵引丝的中心夹角为30〜150°。 [0022] When a dragline of two, when two stiffener, two reinforcing ribs in the axial center of side of the tubular body, on a cross section of the tubular body, wherein any one of a rib central angle of pull wire is 30~150 °. 优选的,任意一根加强筋与其中一根牵引丝的中心夹角为80〜100°。 Preferably, any one stiffener and wherein a central angle of pull wire is 80~100 °.

[0023] 两条加强筋处在所述管体的轴心对侧即两条加强筋处在所述管体的两相对侧,这样,鞘管在两条加强筋沿径向的连线方向上不易折弯,只能在两条加强筋连线的中垂线方向折弯,拉动牵引丝时,鞘管的远端必然且更容易的朝最易弯曲的方向(牵引丝的方向)弯曲。 [0023] The two reinforcing ribs in the opposite side of the axis of the tubular body i.e. two reinforcing ribs in the connecting direction of two opposite sides of the tube, so that two reinforcing ribs in the sheath in the radial direction when the easy bending, only two stiffener connection pERPENDICULAR bending, pulling the pull wire, the distal end of the sheath necessarily more readily toward the most flexible in the direction (wire pulling direction) is bent .

[0024] 当然,两条加强筋也可不相对布置。 [0024] Of course, the two may not be arranged opposite the reinforcing ribs. 在管体的任意截面上,两根加强筋的中心夹角小于180°,牵引丝处于任意加强筋与管体轴线沿径向的连线的一侧。 On a cross section of the tubular body, two center rib angle of less than 180 °, the pull wire is any side reinforcing ribs and the radial axis of the tube connection. 这样,鞘管在每根加强筋与管体轴线沿径向的连线方向均不宜弯曲,因此,在设置牵引丝时,应避免牵引丝分布在任意一条加强筋与管体轴线沿径向的连线方向。 Thus, each of the reinforcing sheath in the connecting direction with the axis of the body ribs are not bent radially, thus, when the pull wire is provided, to avoid any distribution of a pull wire stiffener and the radial axis of the tubular body connection direction.

[0025] 所述的可调弯鞘管还包括与所述管体连通的膨胀段,所述膨胀段与管体的远端一侧相连且用于容纳植入器械。 Adjustable bending sheath according to [0025] of the expansion section further comprising a communication tube, the distal end side of the expansion section is connected with the tubular body and for receiving the implantable device.

[0026] 所述膨胀段与管体之间通过增厚的过渡段相连接,且该过渡段的外壁与所述膨胀段和管体均平滑过渡,所述加强筋的远端延伸并固定在该过渡段内。 [0026] The expansion section between the tubular body and connected by a transition section thickened, and the transition section and the outer wall and the expansion section are smooth transition tube, the distal end of the reinforcing rib extends and is fixed the transition within the segment. 管体与膨胀段相连接的部位为薄弱环节,过渡段可避免调弯时该处打死折,影响植入器械的释放,另外,在行进过程中,膨胀段内容纳有植入器械,并使植入器械处于压缩状态,因此膨胀段具有较强的径向支撑力,且植入器械在一定程度上影响了膨胀段的柔顺性,加强筋的远端固定在该过渡段内可避免加强筋对其顺应性产生影响。 When the tubular body portion of the expansion section is connected to the weak link, the transition section can be adjusted to avoid killing off the premises bend, impact Implanted release devices, Further, during traveling, the expansion section housed implant instrument, and the implant device in a compressed state, so the expansion segment has a strong radial strength and flexibility of the implantation instrument affect to some extent the expansion section, the reinforcing rib is fixed within the distal end of the transition period can be avoided strengthen tendons impact on its compliance.

[0027] 本实用新型还提供了一种输送系统,包括所述的可调弯鞘管、置于所述可调弯鞘管内的鞘芯以及与所述可调弯鞘管和鞘芯近端固定的操作手柄,牵引丝的近端固定在所述的操作手柄上。 [0027] The present invention further provides a delivery system comprising an adjustable bend the sheath, the sheath core disposed within the adjustable bending sheath and the adjustable bending sheath and the sheath proximal end of the core fixed operating handle, the proximal end of the pull wire is fixed to the operating handle.

[0028] 所述的鞘芯包括芯管,所述芯管的远端固定有引导头和介入器械固定头,所述芯管处于引导头和植入器械固定头之间的部位为用于放置植入器械的安装段,所述安装段的外周设有管壁加厚层。 [0028], wherein the sheath core comprises a core tube, core tube is fixed to the distal end of the guide head and a head fixing interventional instrument, the core tube in the region between the guide head and the head is fixed to the implantation instrument for placement implantable device mounting section of the mounting section is provided with an outer peripheral wall thicker layer.

[0029] 通过设置管壁加厚层,能够填充植入器械与安装段之间的间隙,克服植入器械某些部位与安装段之间存在的悬空现象,避免了输送系统在转弯时因较大空隙的存在而弯折。 [0029] By providing the wall thickening layer, it is possible to fill a gap between the implanted device and the mounting section, to overcome the flying phenomenon between the mounting section and some parts of the implant instrument, the delivery system is avoided due to the more when cornering there is a large gap and bent. 由于不同植入器械的结构差异,其与安装段之间间隙存在的位置、大小等也有所差别,因此,管壁加厚层的位置、形状、厚度等可根据具体的植入器械的结构进行设置,使其与相应的间隙相适应。 Due to structural differences in different implantable devices, there is a gap between the mounting section and the position, size, etc. are also different, and therefore, the position of the wall thick layer, the shape, thickness and the like can be performed according to the specific configuration of the implantation instrument settings to adapt to the respective gap. 为保证输送系统的柔顺性,所述管壁加厚层可采用有机硅、聚氨酯等弹性较好的材料制成。 To ensure compliance delivery system, the elastic layer may be thickened wall material is preferably a silicone, polyurethane or the like.

[0030] 对于管壁加厚层的安装方式并没有严格限制,所述管壁加厚层与安装段一体成型或固定套设在安装段的外部。 [0030] For mounting the wall thick layer is not strictly limited, the thicker wall sections are integrally formed with the mounting layer or a fixing sleeve provided outside the mounting section. [0031] 所述管壁加厚层的至少一端为外径逐渐减小的锥形。 [0031] at least one end of said tapered outer diameter is gradually reduced in wall thickening layer. 锥形结构使管壁加厚层的外径逐渐过渡,能够更好的填充植入器械与安装段之间的悬空位置,且可以避免损伤植入器械,同时也不影响植入器械的释放。 Tapered structure so that the outer diameter of the wall thickening layer a gradual transition, between the vacant position of the implantable device can be better filled with the installation section, and to avoid damage to the implant instrument, while not affecting the release implant devices.

[0032] 本领域人员可以理解,在本实用新型中所提及的鞘管、牵引丝、加强筋等的远端是指在输送系统中,远离操作手柄的一端,所述鞘管、牵引丝、加强筋等的近端是指在输送系统中,靠近操作手柄的一端。 [0032] Those skilled in the art can be appreciated, sheath mentioned in the present invention, the traction wire, the distal end of reinforcing ribs and the like is meant in the delivery system, away from the operating end of the handle, the sheath, dragline , proximal bead like means in the delivery system, near one end of the operating handle.

[0033] 与现有技术相比,本实用新型的有益效果为: [0033] Compared with the prior art, the beneficial effects of the present invention is:

[0034] (1)公开号为CN102743196A的中国专利文献公开了一种复合管,包括依次设置的内层、加强层和外层,通过在加强层设置加强筋以增强复合管的径向受力,而本实用新型改变设计思路,利用加强筋发挥自定位调弯的作用,并对牵引丝和加强筋进行合理设置,提高了鞘管远端弯曲方向的可控性,医生可方便的通过牵引丝将鞘管远端弯曲、移动至目标方向或位点,降低了手术难度。 [0034] (1) Publication of Chinese Patent No. CN102743196A discloses a composite pipe comprising an inner layer are sequentially disposed, and an outer reinforcing layer, the reinforcing layer by the reinforcing ribs disposed radially reinforced composite pipe to force , while the present invention is to change the design ideas, with the reinforcing rib to play the role of self-alignment adjusting bend, and the pull wire and bead reasonable set to improve the controllability of the bending direction of the distal end of the sheath, the doctor can easily by pulling the distal end of the sheath wire bending and movement direction to the target or site, reducing the difficulty of operation.

[0035] (2)本实用新型的鞘管的抗折性好,提高了安全性。 [0035] (2) of the present invention bending sheath good, improves security.

附图说明 BRIEF DESCRIPTION

[0036] 图1为本实用新型可调弯鞘管的结构示意图; [0036] FIG. 1 is a schematic structural diagram of an adjustable bend disclosure sheath;

[0037] 图2为图1所示的可调弯鞘管沿AA方向的剖视图; [0037] FIG. 2 is a cross-sectional view shown in Figure 1 an adjustable bending sheath taken along line AA;

[0038] 图3为图1所示的可调弯鞘管远端弯曲时的状态图; A state diagram when the distal end of the adjustable pipe bend of the sheath [0038] FIG. 3 is shown in Figure 1 is bent;

[0039] 图4为图1所示的可调弯鞘管中另一种牵引丝与加强筋布置方式的结构示意图; Adjustable bending sheath [0039] FIG. 4 is shown in FIG. 1 dragline another embodiment of the bead structure schematic arrangement;

[0040] 图5为本实用新型设有一条加强筋和两根牵引丝的鞘管的结构示意图; [0040] FIG. 5 is a schematic structural diagram of an invention provided with reinforcing ribs and two pulling wire sheath;

[0041] 图6为本实用新型设有一条加强筋和一根牵引丝的鞘管的结构示意图; [0041] FIG. 6 of the present invention is provided with a rib structure diagram of a pull wire and sheath of;

[0042] 图7为本实用新型设有两条加强筋和一根牵引丝的鞘管的结构示意图; [0042] FIG. 7 is provided with the present invention and a schematic view of a two stiffeners of pull wire sheath;

[0043] 图8为本实用新型设有两条加强筋和一根牵引丝的另一种鞘管的结构示意图; [0043] FIG. 8 of the present invention is provided with two rib schematic structural diagram of another sheath and a traction wire;

[0044]图9为本实用新型可调弯鞘管的第二种实施方式的结构示意图; [0044] FIG. 9 is a schematic structural diagram of a second embodiment of the invention, the sheath of an adjustable bend;

[0045] 图10为本实用新型输送系统的结构示意图; [0045] FIG. 10 is a structural schematic view of the delivery system of invention;

[0046] 图11为现有技术中主动脉瓣膜置换装置的结构; [0046] FIG. 11 is a configuration apparatus of the prior art valve replacement aortic;

[0047] 图12为现有技术中,图11所示的主动脉瓣膜置换装置装载入输送系统时的结构示意图。 [0047] FIG. 12 is a prior art, aortic valve replacement device 11 shown in FIG schematic structural view loaded into a delivery system.

[0048] 图13为图11所示的主动脉瓣膜置换装置装载入本实用新型的输送系统时的结构示意图。 Aortic valve replacement device [0048] 13 is shown in FIG. 11 is a schematic structural view loaded into the delivery system of the present invention.

[0049] 图14为本实用新型的输送系统穿越主动脉弓的结构示意图; [0049] FIG. 14 is a schematic structural diagram of a delivery system invention through the aortic arch;

[0050] 图15为图14中主动脉弓部位的放大图; [0050] FIG 15 FIG 14 is an enlarged view of part of the aortic arch;

[0051] 图16为图15沿BB方向的剖视图; [0051] FIG. 16 is a sectional view along the BB direction of FIG. 15;

[0052] 图17为本实用新型的输送系统穿越主动脉弓后,鞘管的远端向血管中心移动的结构示意图; After crossing the aortic arch, the distal end of the sheath moves to the center of the vessel novel structural diagram of a delivery system [0052] FIG. 17 is practical;

[0053] 图18为本实用新型的输送系统行进至植入位点后释放主动脉瓣膜置换装置的结构示意图。 [0053] FIG. 18 is a structural diagram of the invention the delivery system travels to the implantation site of the release of the aortic valve replacement device.

具体实施方式[0054] 下面结合具体实施例对本实用新型作进一步阐释。 DETAILED DESCRIPTION [0054] The following examples further explained with reference to specific embodiments of the present invention for.

[0055] 图1显示了本实用新型可调弯鞘管的第一种实施方式的结构,包括依次连通的膨胀段102和管体101。 [0055] FIG. 1 shows the structure of the present invention a first embodiment of an adjustable bend sheath, comprising successively expansion section 102 and the communication tube 101.

[0056] 膨胀段102为管状结构,在介入手术中,膨胀段102能够预压缩植入器械,使植入器械处于被压缩状态直至行进到植入位点后将其释放,膨胀段应具备一定的径向的弹力和轴向的支撑力,同时膨胀段内壁应尽可能的光滑,以方便释放、回收植入器械。 [0056] The expansion section 102 is a tubular structure, in interventional procedures, the expansion section 102 can be pre-compressed implantation instrument, the implant device in a compressed state until it is released after traveling to the site of implantation, the expansion section should have some supporting force and axial force of the radial expansion while the inner wall segment should be as smooth as possible to facilitate the release, implantation instrument recovered.

[0057] 管体101与膨胀段102相连通,该管体101的口径小于膨胀段102。 [0057] The tube 101 communicates with the expansion section 102, the diameter of tube 101 is smaller than the expansion section 102. 如图2所示,管体101的管壁内沿轴向方向开设有两个通道103,每个通道103内均设有一根牵引丝104,牵引丝104能够在通道103内滑动,这两根牵引丝104的远端固定在管体101的远端端部,牵引丝104的近端沿着各自的通道延伸出管体101与控制手柄相连。 As shown, the body defines two inner wall 101 in the axial direction two channels 103, each provided with a pull wire 104 in each channel 103, the pull wire 104 can slide within the channel 103, these two the distal end of pull wire 104 is secured at the distal end 101 of the tubular body, the proximal end of pull wire 104 extends out of the control handle connected to the tubular body 101 along the respective channels.

[0058] 管体101的管壁内沿轴向方向还设有两根条形的加强筋105,这两根加强筋105处在管体101轴心的两相对侧,且从管体101的远端端部延伸至近端端部。 [0058] axial direction within the tubular body wall 101 is also provided with two strip-shaped rib 105, which rib 105 at two opposite sides of the axis of the tube 101 and the tube 101 from a distal end portion extending to the proximal end. 通常,沿径向方向,管体101由内至外依次包括内层106、加强层107和外层108。 Typically, in the radial direction, the tubular body 101 includes, in order from inside to outside an inner layer 106, the reinforcing layer 107 and an outer layer 108. 内层106和外层108可采用相同或者不同的高分子润滑材料制成,如内层106可采用聚四氟乙烯材料,外层108可采用聚乙烯、聚氨酯等材料。 The inner layer 106 and outer layer 108 can be the same or different lubricating polymer material such as PTFE inner layer 106 may be employed, the outer layer 108 can be polyethylene, polyurethane and other materials. 加强层107为钢丝编织的弹簧管结构,弹簧管结构不仅使鞘管具备一定的轴向支撑力,同时,其弯曲柔韧性能好,使得鞘管径向的柔顺性更好,本实用新型中,加强筋105可紧贴加强层107设置。 Reinforcing layer 107 is a spring steel wire braided tube structure, not only the spring sheath tube structure with a certain axial supporting force, while its good bending flexibility properties, so that better compliance to the diameter of the sheath, in the present invention, reinforcing rib 105 may be in close contact layer 107 is provided.

[0059] 在管体101的周向上,加强筋105与牵引丝104间隔分布。 [0059] In the periphery of the tubular body 101 upwardly, the pull wire 105 and the rib 104 spaced.

[0060] 两条加强筋不仅增强了管体的抗拉强度,提高管体的轴向支撑强度,保证了鞘管的推送性,同时,还定位了管体的折弯方向,鞘管在两条加强筋沿径向的连线方向(即图1中所示的Z轴方向)上不易折弯,当鞘管沿着血管壁行进在曲折复杂的人体脉管系统中,鞘管会自适应的在两条加强筋连线的垂线方向(即图1中所示的1轴方向)折弯,图3示出了鞘管的远端弯曲时的状态,当鞘管循迹穿越血管的弯曲部位后,鞘管会自适应的将易弯曲的方向朝向血管的中心,而牵引丝与加强筋在管体的周向上间隔分布,此时直接拉动牵引丝,即可使鞘管的远端向血管的中心弯曲。 [0060] The two reinforcing ribs not only enhance the tensile strength of the tubular body, the tubular body to improve the strength of the axial support, to ensure the pushability of the sheath, while also positioning the bent direction of the tube body, the two sheath connection of reinforcing ribs in the radial direction (i.e., Z-axis direction shown in FIG. 1) on the bending easy when the adaptive sheath travels along the vessel wall in the complex tortuous vasculature of a human body, the sheath would two bead wires in a perpendicular direction (i.e. axis direction shown in FIG. 1) is bent, FIG. 3 shows a state where the distal end of the sheath is bent, the sheath when the tracking through the vessels after the bent portion, the sheath will be pliable adaptive direction toward the center of the blood vessel, and the pull wire and the reinforcing ribs spaced in the circumferential direction of the tubular body, when the pull wire is pulled directly, to the distal end of the sheath bending toward the center of the vessel.

[0061] 在设置牵引丝时,牵引丝应避免过度靠近加强筋,否则需对牵引丝施加较大的拉力才能够牵动鞘管的远端折弯,操作难度较大。 [0061] When the pull wire is provided, close to the pull wire to avoid excessive rib, or need traction filament for greater tension to be able to affect the distal end of the sheath is bent, the operation difficult. 通常,在管体的任意截面上,其中一根牵引丝104与任意一根加强筋105的中心夹角A不小于30°,当任意一根牵引丝与任意一根加强筋的中心夹角为90°时(如图4),此时牵引丝拉动鞘管远端折弯时所需的拉力最小,极易控制。 Typically, on a cross section of the tubular body, wherein a pull wire 104 with any one of the reinforcing ribs 105 center angle A is not less than 30 °, when any arbitrary one of a pull wire reinforcing rib center an angle of when 90 ° (FIG. 4), when the movable sheath strands traction force required minimum bend the distal end, easy control.

[0062] 值得注意的是,在本实用新型中,加强筋的数目并不仅限于两条,如5所示,管体101的管壁内沿轴向方向开设有两个通道103,每个通道103内均设有一根牵引丝104,管体101的管壁内沿轴向方向设有一根加强筋105,鞘管在加强筋的方向上仍然不易发生折弯,仍可达到自定位调弯的目的,但为了取得更好的效果,在仅设置一根加强筋106的情况下,该加强筋106可适应性的加粗(与设置两根加强筋的情况相比)。 [0062] It is noted that, in the present invention, the number of the reinforcing ribs is not limited to two, as shown in FIG. 5, the tubular body 103 defines two channels 101 in the axial direction of the inner wall of each channel 103 has an inner pull wire 104, tubular body 105 is provided with a reinforcing rib in the axial direction of the inner wall 101 of the sheath still easily occurs in the direction of bending of the stiffener, positioning adjustment can be attained from the bend purposes, but in order to achieve better results, in the case where only one reinforcing rib 106 is provided, the rib 106 may be adaptive bold (as compared with a case where two stiffener).

[0063] 另外,牵引丝也可以仅设置为一根,图6和图7示出了设置一根牵引丝时管体的结构,如图6所示,管体101的管壁内沿轴向方向开设有一个通道103,通道103内设有一根牵引丝104,管体101的管壁内沿轴向方向设有一根加强筋105。 [0063] Further, the pull wire may be provided to only one, in FIG. 6 and FIG. 7 shows the structure of the tubular body when a dragline provided, as shown in Figure 6, the tubular body in the axial direction of the inner wall 101 direction defines a channel 103, channel 103 equipped with a pull wire 104, tubular body 105 is provided with a reinforcing rib in the axial direction of the inner wall 101. 图7示出的管体的结构与图6类似,不同之处在于,管体101的管壁内沿轴向方向设有两根加强筋105,这两根加强筋处于管体轴心的两相对侧,即在管体的任意截面上,两根加强筋105的中心夹角为180°,当然,两根加强筋105的中心夹角也可小于180°,如图8所示,两根加强筋的中心夹角约为130°,此时,每根加强筋与管体轴线沿径向的连线方向(m和η)均不宜弯曲,因此,牵引丝应避免处在加强筋与轴线沿径向的连线方向。 Figure 7 configuration shown in FIG tubular body 6 is similar, except that, in the axial direction of the inner wall 101 of tubular body 105 is provided with two reinforcing ribs, the reinforcing ribs in these two tube axis two the opposite side, i.e., on a cross section of the tubular body, two reinforcing ribs 105 center angle is 180 °, of course, the angle between the center of two reinforcing ribs 105 may also be less than 180 °, shown in Figure 8, two rib center an angle of about 130 °, in this case, each reinforcing rib connecting the tubular body axis of the radial direction (m and [eta]) are not bent, therefore, should be avoided in the pull wire and the axis of the rib in the radial direction of the connection. 显然的,牵引丝的数量并不影响加强筋的自定位调弯的功能,由于一根牵引丝只能够实现单向调弯,当需要向相背于牵引丝的方向调弯时,可通过操作手柄将鞘管旋转180°左右后,再拉动牵引丝。 Obviously, the number of dragline silk from the bead does not affect the positioning of the transfer function of bending, since only a pull wire can be adjusted one-way bend, when the need to transfer the bending direction opposite to the pulling wire, by operating after rotating the handle sheath around 180 °, and then pull the pull wire.

[0064]图9示出了本实用新型可调弯鞘管的第二种实施方式,本实施方式与第一种实施方式类似,不同的之处在于:膨胀段102与管体101之间通过增厚的过渡段109相连接,且该过渡段109的外壁与膨胀段102和管体101均平滑过渡,加强筋104的远端延伸并固定在过渡段109内。 [0064] FIG. 9 shows a second embodiment of the present invention, an adjustable pipe bend of the sheath, similar to the embodiment of the present embodiment and the first embodiment, except in that: the expansion section 102 between the tube 101 and through thickening of the transition section 109 is connected to the transition section and expansion section 102 and the outer wall 101 and the pipe 109 are a smooth transition, reinforcing distal rib 104 extends and is fixed in the transition section 109. 图9中虚线示意了现有鞘管中膨胀段102与管体101连接部位的结构,膨胀段102与管体101直接对接在一起,两者的连接部位薄弱,易弯折,而通过设置过渡段则能够克服该缺陷。 The broken line in FIG. 9 illustrates a conventional expansion section 102 in the sheath structure, the expansion section 102 and the tube 101 is directly butted together the tube connection portion 101, connecting portion between the two weak and pliable, and by providing the transition segment is possible to overcome this drawback.

[0065] 值得注意的是,在本实用新型不同实施方式之间,除非明显不可组合外,各实施方式的技术特征均可相互进行借鉴。 [0065] It is noted that, between the different embodiments of the present invention, can not be combined unless the obvious technical features of each embodiment can be learn from each other.

[0066] 参见图10,本实用新型还提供了一种输送系统,包括鞘管100、鞘芯200以及与鞘管的近端、鞘芯的近端相固定的控制手柄(图中未显示)。 [0066] Referring to FIG 10, the present invention further provides a delivery system comprising a proximal end of the sheath 100, the sheath 200 and the core with the sheath, the sheath proximal end of the core fixed to the control handle (not shown) .

[0067] 鞘芯包括芯管201、引导头202和植入器械固定头203。 [0067] The sheath core comprises a core tube 201, the guide head 202 and fixing head 203 the implantation instrument.

[0068] 引导头202与芯管201的远端端部固定连接,植入器械固定头203带有通孔和定位槽,位于芯管201的远端,具体可采用常规的结构,如可参照公开号为CN101953724A,发明名称为“用于装载人造瓣膜置换装置的支架固定头”的中国专利文献。 [0068] 202 of the core tube guide head 201 is fixedly connected to the distal end, the implant instrument mounting head 203 with through holes and detents located on the distal end of the core tube 201, using conventional concrete structures, such reference is Publication No. CN101953724A, entitled "brackets for loading the head of an artificial valve replacement means" a Chinese patent document.

[0069] 芯管201为带有通孔的空心管,芯管201处于引导头202和植入器械固定头203之间的部位为用于放置植入器械的安装段204。 [0069] The core tube 201 is a hollow tube with a hole, the core tube 201 in the region between the head 202 and the head 203 fixed implantation instrument guide for implant placement instrument mounting section 204. 该安装段204的外周固定套设有管壁加厚层205。 The mounting section 204 is provided with an outer peripheral wall thicker layer of the fixing sleeve 205.

[0070] 管壁加厚层205用于填充植入器械与安装段之间的悬空部位,由于植入器械之间存在的差异,由此植入器械与安装段之间的悬空部位、悬空大小、形状等也会有所不同,因此,管壁加厚层的形状、设置的部位以及管壁加厚层的尺寸均可以根据特定的植入器械进行设置。 [0070] thickened wall layer 205 is used to fill the vacant portion between the implantable device and the mounting section, due to the differences between the implanted devices, whereby the implant instrument vacant portion between the mounting section, the size of the vacant and shape will be different, and therefore, the shape of the wall thicker layer, and the size of the wall portion disposed thicker layer can be set according to the particular implantable device.

[0071] 为保证输送系统植入器械部位的柔顺性,管壁加厚层205可采用弹性较好的材料制成,如有机硅、聚氨酯等。 [0071] In order to ensure compliance implantable device delivery system site 205 can be more elastic material layer is made thicker the wall, such as silicones, polyurethanes and the like.

[0072] 此外,管壁加厚层与安装段除可采用固定套装的安装方式外,管壁加厚层与安装段还可采用一体成型的方式进行加工。 [0072] In addition, wall thickening layer except the mounting section can be fixed to suit installation, wall thickening layer may also be used with the mounting section integrally molded processing manner.

[0073] 鞘管100套在鞘芯200的外部,可相对鞘芯200滑动,对植入器械进行释放或回收,鞘管100可采用如上所述的结构。 [0073] In the sheath 100 of the outer sheath of the core sleeve 200, 200 may be slidable relative to the sheath core, to release or implantation instrument for recovery, 100 may employ sheath structure as described above.

[0074] 现结合主动脉瓣膜置换术进一步阐释本实用新型。 [0074] Aortic valve replacement are combined with further illustrate the present invention.

[0075] 图11显示了现有的一种主动脉瓣膜置换装置的结构,由支架和固定在支架内的假体瓣膜(未显示)构成,支架为由依次连接的主动脉支架401、瓣膜支架402和流进道支架403构成的网状的筒形结构,流进道支架403带有覆膜,假体瓣膜缝制在瓣膜支架处。 [0075] FIG. 11 shows the structure of a conventional aortic valve replacement device, and fixed by the bracket prosthetic valve within the stent (not shown) constituted by the aortic stent stent 401 are sequentially connected, the valve support 402 mesh and flows into the cylindrical structure 403 constituting the channel bracket, the bracket 403 with a flow passage into the film, the prosthetic valve sewing at the valve support. 主动脉支架401的顶沿设有三个锁件404,这三个锁件的高度可相同或者不相同。 Aortic stent 401 is provided with three top edge of the lock member 404, the height of the three lock member may be the same or different. 支架在未释放时是收拢的状态,为致密的管状结构,通过记忆金属材料的管材经过激光切割加工而成。 When the stent collapsed state is not released, a dense tubular structure by a memory metal tubing material processed after laser cutting. [0076] 术时,先将主动脉瓣膜置换装置装载在输送系统上,首先使鞘芯的植入器械固定头伸出鞘管,引导头穿过管状的主动脉瓣膜置换装置后,将主动脉瓣膜置换装置固定在植入器械固定头外壁的定位槽中,再将鞘管完全包裹住主动脉瓣膜置换装置。 After [0076] When the surgery, aortic valve replacement first means mounted on the conveyor system, first, the implantation instrument sheath core fixing head out of the sheath, through the tubular guide head aortic valve replacement device, the aorta valve replacement implanted device is fixed in the first fixing device positioning grooves of the outer wall, and then completely wrapped sheath aortic valve replacement device.

[0077] 图13示出了本实用新型的输送系统装载入主动脉瓣膜置换装置后的状态,此时,鞘管100的膨胀段102套在鞘芯200的引导头202、安装段204和植入器械固定头203的外部,主动脉瓣膜置换装置400套装在鞘芯的安装段204,整个主动脉瓣膜置换装置400被膨胀段102压缩,而管壁加厚层205大致位于主动脉瓣膜置换装置的假体瓣膜以上部位,与未设有管壁加厚层的现有输送系统相比(图12),由于未设有管壁加厚层,主动脉支架401部位与鞘芯500之间呈现较松稀的空隙,支架的锁件404部位与鞘芯500之间悬空600明显,弯曲时容易从悬空部位或稀疏部位产生弯折,很多时候会引起鞘管变形出现打死折现象。 [0077] FIG. 13 illustrates a delivery system according to the present invention loaded into a state of aortic valve replacement device, this time, the expansion section 100 of the sheath 102 sets the guide head 202 at the sheath core 200, 204 and the mounting segment explants external fixation device head 203 of the aortic valve replacement device 400 is set 204, the entire aortic valve replacement device 400 is installed in the expansion section 102 compresses sheath core section, and the wall 205 is substantially thicker layer of the aortic valve replacement device over parts of the valve prosthesis, the delivery system compared with the conventional thick wall layer is not provided (FIG. 12), since no wall is provided between the thickening layer 500, portion 401 and the sheath core presenting aortic stent loose thin gap, floating lock bracket 404 and the sheath core portion between 500,600 apparent from floating prone bent portion bending portion or sparse, often cause deformation occurs sheath killed off phenomenon. 而本实用新型的管壁加厚层正好填充了上述的间隙,植入器械400与鞘芯之间紧密配合,有效防止了输送系统在转弯时该部位出现打折现象,大大降低了鞘管打折后造成器械释放/回收失败,鞘管加强层断裂刺出等对患者造成生命危险的风险。 And the present invention the wall thickening layer exactly fills the above gap, a tight fit between the implant device 400 and the sheath core, effectively preventing the transport system after the portion discounts phenomenon occurs during cornering, greatly reducing the sheath discounts resulting in the release of equipment / recycling failure, the risk of fracture layer thrusts and other life-threatening to the patient sheath strengthened.

[0078] 主动脉瓣膜置换装置装载完成后,将输送系统连同主动脉瓣膜置换装置沿着已经建立好的导丝轨道,输送至瓣膜植入位点。 [0078] After completion of the loading apparatus aortic valve replacement, the delivery system along with aortic valve replacement device along the established track guidewire, conveyed to the valve implant site. 一般先从股动脉穿刺,经腹主动脉、降主动脉,再穿过主动脉弓,逆行至主动脉根部的主动脉瓣位置进行瓣膜的置换。 Usually start femoral artery, abdominal aorta, the descending aorta, through the aortic arch and then, the position of the aortic valve to the retrograde aortic root replacement valve. 整个过程中,医师通过控制手柄推送鞘管和鞘芯使其沿着导丝前进,虽然人体的脉管系统曲折复杂,但是鞘管自身具有良好的顺应性,能够自适应的调整弯曲方向,以顺应人体的脉管系统而向前行进,由于鞘管弯曲张力向外,鞘管始终紧靠着血管壁行进(如图14、图15所示),主动脉弓300是鞘管远端到达植入位点后经历的最后一个大弯曲,由于鞘管的管体内设置有加强筋,定位了管体的折弯方向,在鞘管的远端经过主动脉弓时,鞘管会自适应的在两条加强筋连线的垂线方向折弯,当穿过主动脉弓后,鞘管的远端在血管内的状态如图16所示(以管体设有两根牵引丝和两条加强筋,管体截面上,任意一根牵引丝与加强筋的中心夹角为90°为例示意),可见鞘管100紧靠血管壁301,且牵引丝104正对血管的中心,即鞘管易弯曲的方向正对血管的中心,此时,直接牵动牵 Throughout the process, so that the physician advances along the guide wire sheath by pushing the control handle and sheath-core, while the body's tortuous vasculature complex, but the sheath itself has a good compliance, the bending direction can be adjusted adaptively to conform to the body's vasculature and travel forward, since the sheath is bent outward tension, against the sheath always travel vessel wall (FIG. 14 and FIG. 15), the aortic arch 300 is the distal end of the sheath reaches the site of implantation after the last point experience large bending, since the tubular body of the sheath is provided with a stiffener, positioning the bending direction of the tube body, through the aortic arch when the distal end of the sheath, the sheath tube will adaptive bead in two bent perpendicular direction wire, when passing through the aortic arch, the distal end of the sheath in the state of the blood vessel as shown in (a tube body is provided with two pulling wires and two reinforcing ribs 16, the cross section of the tubular body , any of a pull wire and a central rib angle of 90 ° schematically an example), the sheath 100 is visible against the vessel wall 301 and pull wire 104 is the center of the vessel, i.e. flexible sheath facing the direction cardiovascular, in which case, directly affects the retractor 丝104,如图17所示,鞘管便容易的向血管的中心位置移动(M方向),继续推动鞘管和鞘芯,便可使其穿过主动脉瓣302的瓣膜中心0,此时,使鞘管向远离引导头的方向移动,可将主动脉瓣膜置换装置释放(如图18所示),待主动脉瓣膜置换装置完全释放后,回收鞘芯、鞘管,释放的主动脉瓣膜置换装置在体温作用下涨开,固定在植入位点,替代自体瓣膜行使功能。 Wire 104, shown in Figure 17, the sheath will easily toward the center position (M direction) of the blood vessel, the sheath and the sheath to continue to promote the core, can be passed through a center of aortic valve 302. 0, then the sheath moves away from the guide head can be released aortic valve replacement means (18), until complete release of the aortic valve replacement device, recovery sheath core, sheath, release aortic valve replacement means opening up under the action of temperature, fixed at the implantation site, replacing the native valve to function.

Claims (14)

1.一种可调弯鞘管,包括管体,其特征在于,所述的管体具有远端和近端,所述管体的管壁内沿轴向设有加强筋和牵引丝,所述牵引丝的远端固定于所述管体的远端,所述牵引丝的近端延伸出管体用于与操作手柄相连。 1. An adjustable bend sheath comprises a tube body, wherein said tubular body having a distal end and a proximal end, the inner wall of the tube body is provided with axially rib and traction wires, the said pull wire distal end fixed to the distal end of the tubular body, the proximal end of the traction wire extending tubular body is connected to the operating handle.
2.如权利要求1所述的可调弯鞘管,其特征在于,所述的牵引丝为一根,所述的加强筋为一条。 2. The adjustable bending sheath according to claim 1, wherein said traction wire is one of the ribs of one.
3.如权利要求2所述的可调弯鞘管,其特征在于,在管体的任意截面上,加强筋与牵引丝的中心夹角为30〜150°。 Adjustable bending sheath according to claim 2, characterized in that, on a cross section of the tubular body, the central reinforcing rib angle of the traction wire 30~150 °.
4.如权利要求1所述的可调弯鞘管,其特征在于,所述的加强筋为一条,所述的牵引丝为两根,两根牵引丝分布于加强筋与管体轴线沿径向的连线的两侧。 4. Adjustable bending sheath according to claim 1, wherein said rib is one of the dragline is two, two pulling wires distributed in the stiffener and the radial axis of the body to both sides of the connection.
5.如权利要求4所述的可调弯鞘管,其特征在于,在管体的任意截面上,加强筋与任意一根牵引丝的中心夹角为30〜150。 5. Adjustable bending sheath according to claim 4, characterized in that, on a cross section of the tubular body, the central reinforcing rib and an arbitrary angle of 30~150 dragline silk. .
6.如权利要求1所述的可调弯鞘管,其特征在于,所述的牵引丝为一根,所述的加强筋为两条。 6. The adjustable bending sheath according to claim 1, wherein said traction wire is one, the two stiffeners.
7.如权利要求6所述的可调弯鞘管,其特征在于,两条加强筋处在所述管体的轴心对侦牝在管体的任意截面上,任意一根加强筋与牵引丝的中心夹角为30〜150°。 7. The adjustable bending sheath according to claim 6, characterized in that the two reinforcing ribs in the axial center of the tubular body of the female investigation on a cross section of the tubular body, a bead of any traction It is the angle between the center wire 30~150 °.
8.如权利要求1所述的可调弯鞘管,其特征在于,所述的牵引丝为两根,所述的加强筋为两条,所述的牵引丝与加强筋在管体的周向上间隔分布。 8. The adjustable circumferential bending sheath according to claim 1, wherein said traction wire is two, two of said ribs, said pull wire in the bead of the tubular body spaced upwardly.
9.如权利要求8所述的可调弯鞘管,其特征在于,两条加强筋处在所述管体的轴心对侦牝在管体的任意截面上,任意一根加强筋与其中一根牵引丝的中心夹角为30〜150°。 9. The adjustable bending sheath according to claim 8, characterized in that the two reinforcing ribs in the axial center of the tubular body of the female investigation on a cross section of the tubular body, and wherein any one stiffener a central angle of pull wire is 30~150 °.
10.如权利要求6或8所述的可调弯鞘管,其特征在于,在管体的任意截面上,两根加强筋的中心夹角小于180°,牵引丝处于任意加强筋与管体轴线沿径向的连线的一侧。 10. Adjustable bending sheath 6 or claim 8, characterized in that, on a cross section of the tubular body, two center reinforcing rib angle of less than 180 °, pull wire stiffener in any of the tubular body side of the axis along the radial connection.
11.如权利要求1所述的可调弯鞘管,其特征在于,还包括与所述管体连通的膨胀段,所述膨胀段与管体的远端一侧相连且用于容纳植入器械。 11. Adjustable bending sheath according to claim 1, characterized in that, with the expansion section further comprising a communication tube, the distal end side of the expansion section is connected with the tubular body and for receiving the implant instrument.
12.如权利要求11所述的可调弯鞘管,其特征在于,所述膨胀段与管体之间通过增厚的过渡段相连接,且该过渡段的外壁与所述膨胀段和管体均平滑过渡,所述加强筋的远端延伸并固定在该过渡段内。 12. Adjustable bending sheath according to claim 11, characterized in that the expansion are connected by the thickened section of the transition between the tubular body and the outer wall of the expanded tubular section and the transition section volume average smooth transition, the distal end of the reinforcing rib extending within and fixed to the transition section.
13.—种输送系统,其特征在于,包括如权利要求1〜12任一项所述的可调弯鞘管、置于所述可调弯鞘管内的鞘芯以及与所述可调弯鞘管和鞘芯近端固定的操作手柄,牵引丝的近端固定在所述的操作手柄上。 13.- seed delivery system comprising an adjustable bend as claimed in claim sheath according to any one 1~12, sheath core disposed within the adjustable bending sheath and the sheath with the adjustable bending the core tube and the proximal end of the sheath fixed operating handle, the proximal end of the pull wire is fixed to the operating handle.
14.如权利要求13所述的输送系统,其特征在于,所述的鞘芯包括芯管,所述芯管的远端固定有引导头和介入器械固定头,所述芯管处于引导头和植入器械固定头之间的部位为用于放置植入器械的安装段,所述安装段的外周设有管壁加厚层。 14. A delivery system according to claim 13, wherein the sheath core comprises a core tube, the distal end of the core tube is fixed to the guide head and a head fixing interventional instrument, the core tube and in the guide head implantation site between the instrument mounting head for placement of the implant device mounting section of the mounting section is provided with an outer peripheral wall thicker layer.
CN201320549231.9U 2013-09-04 2013-09-04 Adjustable bending sheath canal and conveying system with same CN203539840U (en)

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CN 201310397312 CN103446655A (en) 2013-09-04 2013-09-04 Deflectable sheathing canal and delivery system with deflectable sheathing canal
CN201320549231.9U CN203539840U (en) 2013-09-04 2013-09-04 Adjustable bending sheath canal and conveying system with same

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CN 201310397312 CN103446655A (en) 2013-09-04 2013-09-04 Deflectable sheathing canal and delivery system with deflectable sheathing canal
CN201320549231.9U CN203539840U (en) 2013-09-04 2013-09-04 Adjustable bending sheath canal and conveying system with same
PCT/CN2014/085428 WO2015032291A1 (en) 2013-09-04 2014-08-28 Adjustable bent sheath tube, and delivery system having same

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CN104287787A (en) * 2014-11-03 2015-01-21 上海欧太医疗器械有限公司 Traction fiber gathering assembly, corresponding minimally invasive instrument conveying device and gathering method
WO2015032292A1 (en) * 2013-09-04 2015-03-12 杭州启明医疗器械有限公司 Sheath-core for delivering interventional device and delivery system comprising same

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CN103446655A (en) * 2013-09-04 2013-12-18 杭州启明医疗器械有限公司 Deflectable sheathing canal and delivery system with deflectable sheathing canal
WO2015032291A1 (en) * 2013-09-04 2015-03-12 杭州启明医疗器械有限公司 Adjustable bent sheath tube, and delivery system having same
WO2015032292A1 (en) * 2013-09-04 2015-03-12 杭州启明医疗器械有限公司 Sheath-core for delivering interventional device and delivery system comprising same
CN104287787A (en) * 2014-11-03 2015-01-21 上海欧太医疗器械有限公司 Traction fiber gathering assembly, corresponding minimally invasive instrument conveying device and gathering method
CN104287787B (en) * 2014-11-03 2017-05-10 上海欧太医疗器械有限公司 Pull wire bunching assembly and the corresponding delivery device minimally invasive instruments and methods bunching

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