WO2023020301A1 - 一种二尖瓣膜修复支架 - Google Patents

一种二尖瓣膜修复支架 Download PDF

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WO2023020301A1
WO2023020301A1 PCT/CN2022/110484 CN2022110484W WO2023020301A1 WO 2023020301 A1 WO2023020301 A1 WO 2023020301A1 CN 2022110484 W CN2022110484 W CN 2022110484W WO 2023020301 A1 WO2023020301 A1 WO 2023020301A1
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Prior art keywords
limit curve
section
sleeve
mitral valve
wing
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PCT/CN2022/110484
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English (en)
French (fr)
Inventor
刘浩
李超
李云龙
龚霄雁
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苏州茵络医疗器械有限公司
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Publication of WO2023020301A1 publication Critical patent/WO2023020301A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
    • 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
    • A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor

Definitions

  • the invention belongs to the field of medical devices, and in particular relates to a mitral valve repair bracket.
  • mitral valve regurgitation There are about 10 million patients with mitral valve regurgitation ( ⁇ grade 3) that need to be treated in China.
  • the volume of mitral valve surgery is more than 40,000 cases per year. Severe mitral valve regurgitation can cause symptoms such as palpitations, chest tightness, and shortness of breath, and eventually lead to heart failure and death.
  • Surgical valve repair or replacement is considered the standard treatment for this disease.
  • surgery has disadvantages such as large trauma, high risk, and slow recovery. Therefore, the development of minimally invasive and low-risk interventional treatment devices for mitral valve regurgitation has huge social benefits and market demands.
  • the structure of the above-mentioned heart valve device is relatively complicated, and problems of poor postoperative effect and complications are prone to occur in actual clinical use. Therefore, it is necessary to improve its structure to improve the postoperative effect and reduce and further reduce the probability of complications.
  • the technical problem to be solved by the present invention is to provide a mitral valve repair stent, which overcomes the problems of poor postoperative effect and easy discovery of complications of the existing stent.
  • a mitral valve repair bracket which includes a skeleton and a membrane assembly
  • the skeleton includes an upper limiting part, a middle fixing part and a lower limiting part
  • the middle fixing part includes The V-shaped support section and the first casing and the second casing arranged symmetrically on the left and right, the left and right ends of the V-shaped support section are respectively connected to the lower ends of the first casing and the second casing, and the left side of the membrane module
  • the side, the right side and the bottom are connected with the first casing, the second casing and the V-shaped support section in turn, and the front and rear sides of the top of the membrane module are correspondingly provided with a front wing and a rear wing
  • the positioning member includes a first limit curve segment located above the front side and a second limit curve segment located above the rear side, and the first limit curve segment and the second limit curve segment are respectively performed twice on the left and right sides.
  • the rear wing corresponds to the front V-shaped connecting section and the rear V-shaped connecting section
  • the lower limiting member includes a third limiting curved section located below the front side and a fourth limiting curved section located below the rear side.
  • the third limit curve segment and the fourth limit curve segment are respectively connected to the lower ends of the first sleeve and the second sleeve.
  • the present invention can also be improved as follows.
  • the membrane assembly includes a front diaphragm and a rear diaphragm that are separated from each other, and the tops of the front diaphragm and the rear diaphragm are correspondingly provided with the front wing and the rear wing and are connected between the front V-shaped connecting section and the rear V Under the pull of the V-shaped connecting section, they are in an open state away from each other, and the bottoms of the front diaphragm and the rear diaphragm are close to each other and fixed at the bottom tip of the V-shaped support section.
  • the advantage of adopting the above-mentioned further structural improvement is that the membrane assembly of the above-mentioned structure can better cooperate with the front and rear V-shaped connecting sections, so that the membrane assembly has more space to achieve better closure during systole, and enhances the repair of the mitral valve. Effect.
  • one intersection point is located in the upper part and is close to the anterior valve of the mitral valve annulus and At the junction of the rear petals, another crossing point is located at the lower part and close to the upper end of the first sleeve or the second sleeve.
  • the advantage of adopting the above further structural improvement is that it can better realize the self-adaptive shrinkage of the upper stopper in the front-rear direction when the heart is compressed, that is, to adapt to the displacement of the valve ring shrinkage when the heart contracts.
  • both the first sleeve and the second sleeve are three-core tubes, and the three-core tube has three fixed passages extending in the axial direction and passing through, and the three fixed passages are distributed in a triangular shape.
  • the advantage of adopting the above-mentioned further structural improvement is to enhance the fixing effect of the first and second sleeves on the V-shaped support section and each limit curve section, and ensure better stability of the support structure.
  • V-shaped support segment, the first limit curve segment, the second limit curve segment, the third limit curve segment and the fourth limit curve segment are bent and wound by the same memory wire and then heat-set During the winding process, the memory metal wire passes through the three fixed passages of the first sleeve and the second sleeve respectively.
  • the front and rear V-shaped connecting sections can be effectively compressed accordingly, better able to withstand the contraction of the valve annulus displacement caused by heart contraction,
  • the stress is not concentrated in the area other than the front and rear V-shaped connecting sections of the upper limiter, which not only enhances the service life of the stent but also ensures that the upper limiter of the stent is better anchored in the heart valve annulus;
  • the membrane module is improved, and the front and rear wings are respectively added in the middle of the top and the rear wings are matched with the front and rear V-shaped connecting sections of the upper limiter.
  • the advantage is that when the heart contracts, the front and rear V-shaped connecting sections are compressed and directed
  • the slight displacement close to the direction of the membrane module (central area) makes the front and rear wings connected to it also move to the central area, so that the membrane module has more space to adapt to the closing action, ensuring a tighter closing and a better repair effect to prevent backflow Well, the postoperative effect is improved.
  • the arc edge on the top of the improved membrane module is only fixed in the middle by the front and rear wings and the front and rear V-shaped connecting sections, the other areas where the arc edge is not fixed can better adapt to the flow of blood.
  • the flow direction, under the intermittent pressure of the blood flow direction, has better compliance, and can also effectively reduce the incidence of complications in patients after implantation;
  • the memory alloy wires that constitute the V-shaped support section and each limit curve section can be respectively fixed in the three fixing channels of each three-core tube.
  • the effect is better, and it can better prevent the alloy wire from transversally or longitudinally shifting in the casing.
  • the three fixed channels are arranged in a triangle, and the alloy wire in the three-core tube is also arranged in a triangle. Compared with the one channel in the prior art, it is obvious that the use of three-core tubes is more conducive to the stability of the stent structure.
  • Fig. 1 is the axonometric view of a kind of mitral valve repair support provided by the present invention
  • Fig. 2 is a schematic diagram of the skeleton structure of the mitral valve repair stent shown in Fig. 1;
  • Fig. 3 is a top view of the upper stopper of the skeleton structure shown in Fig. 2 and the first sleeve and the second sleeve connected thereto;
  • Figure 4 is an axonometric view of the membrane assembly of the mitral valve repair stent shown in Figure 1;
  • Fig. 5 is the axonometric view of the first casing or the second casing in the frame structure shown in Fig. 2;
  • Fig. 6 is a schematic diagram of the mitral valve repair stent shown in Fig. 1 after being implanted in a designated position of the heart.
  • orientation or positional relationship is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the referred device or element must have a specific orientation, be configured in a specific orientation, and operation, and therefore should not be construed as limiting the invention.
  • the present invention provides a mitral valve repair stent, which includes a skeleton 1 and a membrane assembly 2, the skeleton 1 includes an upper limiting part, a middle fixing part and a lower limiting part, the middle
  • the fixture includes a V-shaped support section 3 and a first sleeve 4 and a second sleeve 5 symmetrically arranged left and right, and the left and right ends of the V-shaped support section 3 are connected to the first sleeve 4 and the second sleeve 5 respectively.
  • the lower end is connected, the left side, the right side and the bottom of the membrane module 2 are connected with the first casing 4, the second casing 5 and the V-shaped support section 3 in turn, and the front and rear sides of the top of the membrane module 2
  • the front wing 8 and the rear wing 9 are correspondingly provided on the side, and the upper limiter includes a first limit curve section 6 above the front side and a second limit curve section 7 above the rear side.
  • the position curve segment 6 and the second limit curve segment 7 are connected to the upper ends of the first sleeve 4 and the second sleeve 5 after crossing twice on the left and right sides and forming an annular part, and the first limit
  • the middle part of the curve section 6 and the second limiting curve section 7 is respectively concaved inward to form a front V-shaped connecting section 10 and a rear V-shaped connecting section 11 correspondingly connected to the front wing 8 and the rear wing 9, and the lower limiting
  • the part includes a third limit curve section 12 located below the front side and a fourth limit curve section 13 located below the rear side, and the third limit curve section 12 and the fourth limit curve section 13 are respectively connected to the The lower ends of the first casing 4 and the second casing 5 are connected.
  • the above-mentioned mitral valve repair stent provided by the present invention is pre-compressed in the catheter at the front end of the sheath tube, enters the chamber of the mitral valve through the apex of the heart through minimally invasive technology, and is installed on the front end of the catheter through the action of the conveyor.
  • the prosthetic stent was slowly released and anchored at the mitral valve site.
  • the situation after placement is shown in Figure 6.
  • the upper limiter of the repair stent is anchored to the wall of the mitral valve ring, and the upper limiter will fit adaptively to the wall of the valve ring during systole and diastole.
  • the membrane assembly 2 includes a front membrane 14 and a rear membrane 15 separated from each other, and the tops of the front membrane 14 and the rear membrane 15 are arranged correspondingly.
  • the bottoms are close to each other and fixed at the tip of the bottom of the V-shaped support section 3 .
  • top of a single front diaphragm or rear diaphragm is in the shape of an upward convex arc
  • the lower part is a structure with a narrow and long connecting part in the middle and an upward convex arc on both sides.
  • the lower end is fixedly connected with the tip of the V-shaped support section.
  • the connections between the front and rear diaphragms, the V-shaped support section, the first casing, the second casing and the front and rear wings are preferably sutured.
  • one intersection point is located at the upper part and is close to the heart after being implanted.
  • another intersection point is located at the lower part and close to the upper end of the first sleeve 4 or the second sleeve 5 .
  • the first sleeve 4 and the second sleeve 5 are three-core tubes, and the three-core tubes have three fixed passages 16 extending in the axial direction and passing through. , the three fixed passages 16 are distributed in a triangular shape.
  • the three-core tube adopts implantable materials, and the memory alloy wires constituting the main body of the skeleton pass through the fixed channels of the first and second sleeves in a certain order.
  • the tightening device exerts pressure on the outer surface of the three-core tube to slightly deform it to achieve the purpose of narrowing the aperture and clamping the alloy wire, and prevents displacement through frictional resistance in the longitudinal direction.
  • each fixed channel passes through an alloy wire, compared with multiple The root alloy wire passes through a channel at the same time.
  • This structure can greatly enhance the effective friction between the outer surface of each alloy wire and the inner surface of the channel of the casing, and can effectively prevent the alloy wire from falling out of the hole, which is conducive to the structural stability of the bracket.
  • the positions between the three fixed channels are fixed so that the inner alloy wire cannot be displaced laterally, so a better positioning and stabilization effect is achieved, and the bracket structure is more stable.
  • the V-shaped support section 3 , the first limit curve section 6 , the second limit curve section 7 , the third limit curve section 12 and the fourth limit curve section 13 It is formed by bending and winding the same memory metal wire and then heat-setting. During the winding process, the memory metal wire passes through the three fixed passages 16 of the first sleeve 4 and the second sleeve 5 respectively.
  • a memory metal wire (alloy wire) is bent and wound (braided) and then heat-set and formed, and the shape is stable after forming.
  • the above-mentioned three-core tube is used for positioning and fixing.
  • the skeleton structure after forming is shown in Figure 2, and the structure after sewing and fixing the membrane module is shown in Figure 1.
  • the entire stent is pre-compressed in the sheath catheter.
  • the two three-core tubes (the first and second sleeves) are closely attached side by side.
  • the repair stent installed at the front end of the catheter is slowly released to the heart. In the internal mitral valve site, the stent is slowly deployed and anchored in the mitral valve site.

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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)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

本发明涉及一种二尖瓣膜修复支架，其包括骨架和膜组件，骨架包括上部限位件、中部固定件和下部限位件，中部固定件包括V形支撑段、第一和第二套管，V形支撑段分别与第一和第二套管下端连接，膜组件顶部的前侧和后侧对应设有前翼和后翼，上部限位件包括位于前侧上方的第一限位曲线段和位于后侧上方的第二限位曲线段，第一和第二限位曲线段分别在左右两侧与第一和第二套管上端连接，第一和第二限位曲线段的中部分别向内凹形成与前翼和后翼对应连接的前V形连接段和后V形连接段。本发明优点为，支架改进后对心房壁作用小且在瓣环处的自适应贴合锚定效果好，改进的膜组件顺应性好且与改进的支架配合，具有更好的闭合性，并发症概率低，术后效果佳。

Description

一种二尖瓣膜修复支架 技术领域
本发明属于医疗器械领域，具体涉及一种二尖瓣膜修复支架。
背景技术
中国需要治疗二尖瓣反流(≥3级)患者约为1000万例。二尖瓣外科手术量为4万余例/年，重度二尖瓣反流可产生心悸、胸闷、气急等症状，最终导致心力衰竭及死亡。外科瓣膜修复或置换术被认为是该病的标准治疗方法。然而，外科手术具有创伤大、风险高、恢复慢等缺点。因此，研发微创、低风险的二尖瓣反流介入治疗器械具有巨大的社会效益和市场需求。
二尖瓣反流介入治疗器械目前已成为国内外心血管器械研发的重点方向之一。目前临床应用的只有MitraClip，由于MitraClip具有很高的安全性、较好的临床疗效以及较多的临床证据，是目前唯一在全世界得到广泛应用、商品化的二尖瓣介入治疗产品。US9517131B2公开了一种心脏瓣膜修复装置，其具有与生物瓣膜上部周边固定连接的中央结构梁以及位于支架上部伸入心房的两组扩张夹梁等，两组扩张夹梁包括可与肺静脉脊作用的上部膨胀梁及与瓣环作用的下部膨胀梁。从整体结构上看，上述的心脏瓣膜装置结构相对复杂，而且在实际临床使用时易出现术后效果欠佳及出现并发症的问题。因此，有必要对其进行结构改进，以提升术后效果并降低并进一步降低并发症发生概率。
发明内容
本发明所要解决的技术问题是提供一种二尖瓣膜修复支架，克服现有支 架术后效果欠佳及易发现并发症的问题。
本发明解决上述技术问题的技术方案如下：一种二尖瓣膜修复支架，其包括骨架和膜组件，所述骨架包括上部限位件、中部固定件和下部限位件，所述中部固定件包括V形支撑段及左右对称设置的第一套管和第二套管，所述V形支撑段左右两端分别与所述第一套管和第二套管下端连接，所述膜组件的左侧、右侧及底部依次与所述第一套管、第二套管和V形支撑段连接，所述膜组件顶部的前侧和后侧对应设有前翼和后翼，所述上部限位件包括位于前侧上方的第一限位曲线段和位于后侧上方的第二限位曲线段，所述第一限位曲线段和第二限位曲线段分别在左右两侧进行两次交叉并形成环状部后与所述第一套管和第二套管上端连接，所述第一限位曲线段和第二限位曲线段的中部分别向内凹形成与所述前翼和后翼对应连接的前V形连接段和后V形连接段，所述下部限位件包括位于前侧下方的第三限位曲线段和位于后侧下方的第四限位曲线段，所述第三限位曲线段和第四限位曲线段分别均与所述第一套管和第二套管下端连接。
在上述技术方案的基础上，本发明还可以做如下改进。
进一步，所述膜组件包括彼此分离的前膜片和后膜片，所述前膜片和后膜片顶部对应设有所述前翼和后翼且在所述前V形连接段和后V形连接段的拉动下呈相互远离的张开状态，所述前膜片和后膜片的底部相互靠近并固定于所述V形支撑段底部尖端处。
采用上述进一步结构改进的好处为，上述结构的膜组件能够更好的与前后V形连接段的配合，实现心脏收缩时膜组件有更大空间实现更好的闭合，增强对二尖瓣膜的修复效果。
进一步，所述第一限位曲线段和第二限位曲线段分别在左右两侧进行的两次交叉中，一个交叉点位于上部且在植入心脏后贴近二尖瓣瓣环的前瓣和后瓣接合处，另一个交叉点位于下部且靠近所述第一套管或第二套管的上 端。
采用上述进一步结构改进的好处为，更好的实现心脏压缩时上部限位件在前后方向的自适应缩小，即适应心脏收缩时瓣环缩小的位移量。
进一步，所述第一套管和第二套管均为三芯管，所述三芯管具有三条沿轴向方向延伸并贯通的固定通道，三条所述固定通道呈三角状分布。
采用上述进一步结构改进的好处为，增强第一和第二套管对V形支撑段和各限位曲线段的固定效果，保证支架结构更好的稳定性。
进一步，所述所述V形支撑段、第一限位曲线段、第二限位曲线段、第三限位曲线段和第四限位曲线段由同一根记忆金属丝弯曲绕制后热定型而成，绕制过程中所述记忆金属丝穿过所述第一套管和第二套管各自的三条所述固定通道。
采用上述进一步结构改进的好处为，整体性好，便于加工。
与现有技术相比，本发明的有益效果是：
(1)优化支架的上部限位件，一方面减少伸入心房的上部膨胀梁，结构更加简单且避免上部限位件对心房壁及肺静脉脊的作用，达到有效降低支架因对左心房壁的刺激作用而引发并发症风险的目的，另一方面上部限位件增设前后V形连接段，当心脏在舒张期时前后V形连接段能够有效释放弹性势能而回弹张大(即有效回弹一定预紧力)，从而保持上部限位件与瓣环壁贴紧，当心脏压缩时，前后V形连接段则能够有效随之压缩，更好的承受心脏收缩带来的瓣环缩小位移量，让应力不至于集中在上部限位件前后V形连接段以外的区域，既增强支架的使用寿命也保证支架的上部限位件较好的锚定在心脏瓣环部位；
(2)对膜组件进行改进，顶部中间左右分别增设前翼和后翼并与上部限位件的前后V形连接段配合，优势在于：心脏收缩时，前后V形连接段受压缩而有向靠近膜组件方向(中心区域)的轻微位移量，使与之连接的前后 翼也向中心区域移动，从而让膜组件有更多空间适应关闭动作，保证关闭更严密，防止返流的修复效果更好，提升术后效果，另外改进后的膜组件由于顶部的圆弧边仅中间通过前后翼与前后V形连接段固定，故圆弧边非固定的其他区域，能够更好的自适应血液的流向，在血液流动方向的间歇压力下，具有更好的顺应性，同样能有效降低植入后患者并发症的发生概率；
(3)当第一和第二套管采用三芯管时，构成V形支撑段和各限位曲线段的记忆合金丝能够在每个三芯管的三个固定通道内分别得到固定，固定效果更佳，能更好的防止合金丝在套管内发生横向或纵向位移，三个固定通道呈三角形分布则三芯管内的合金丝也呈三角形排布，相比于现有技术中一个通道内固定多根合金丝的结构，显然利用三芯管更有利于支架结构的稳定性。
附图说明
图1为本发明提供的一种二尖瓣膜修复支架的轴测图；
图2为图1所示二尖瓣膜修复支架的骨架结构示意图；
图3为图2所示骨架结构的上部限位件及与其连接的第一套管和第二套管的俯视图；
图4为图1中所示二尖瓣膜修复支架的膜组件的轴测图；
图5为图2所示骨架结构中第一套管或第二套管的轴测图；
图6为图1所示二尖瓣膜修复支架植入心脏指定位置后的示意图。
附图中，各标号所代表的部件列表如下：
1、骨架；2、膜组件；3、V形支撑段；4、第一套管；5、第二套管；6、第一限位曲线段；7、第二限位曲线段；8、前翼；9、后翼；10、前V形连接段；11.后V形连接段；12、第三限位曲线段；13、第四限位曲线段；14、前膜片；15、后膜片；16、固定通道。
具体实施方式
以下结合附图及具体实施例对本发明的原理和特征进行描述，所举实例只用于解释本发明，并非用于限定本发明的范围。
在本发明的描述中，若用到“上”、“下”、“左”、“右”、“顶”、“底”、“内”、“外”等指示方位的术语，其指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本发明和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。
如图1至6所示，本发明提供一种二尖瓣膜修复支架，其包括骨架1和膜组件2，所述骨架1包括上部限位件、中部固定件和下部限位件，所述中部固定件包括V形支撑段3及左右对称设置的第一套管4和第二套管5，所述V形支撑段3左右两端分别与所述第一套管4和第二套管5下端连接，所述膜组件2的左侧、右侧及底部依次与所述第一套管4、第二套管5和V形支撑段3连接，所述膜组件2顶部的前侧和后侧对应设有前翼8和后翼9，所述上部限位件包括位于前侧上方的第一限位曲线段6和位于后侧上方的第二限位曲线段7，所述第一限位曲线段6和第二限位曲线段7分别在左右两侧进行两次交叉并形成环状部后与所述第一套管4和第二套管5上端连接，所述第一限位曲线段6和第二限位曲线段7的中部分别向内凹形成与所述前翼8和后翼9对应连接的前V形连接段10和后V形连接段11，所述下部限位件包括位于前侧下方的第三限位曲线段12和位于后侧下方的第四限位曲线段13，所述第三限位曲线段12和第四限位曲线段13分别均与所述第一套管4和第二套管5下端连接。
需要说明的是，本发明提供的上述二尖瓣膜修复支架预压缩于鞘管最前端导管内，通过微创技术经心尖进入心脏二尖瓣的腔室中，通过输送器动作 使安装在导管前端的修复支架缓慢释放并锚定在二尖瓣部位，放入后的情况如图6所示。具体而言，修复支架的上部限位件锚定于二尖瓣瓣环壁，在心脏收缩和舒张时上部限位件会与瓣环壁自适应贴合。
在本发明的一个实施例中，如图1和4所示，所述膜组件2包括彼此分离的前膜片14和后膜片15，所述前膜片14和后膜片15顶部对应设有所述前翼8和后翼9且在所述前V形连接段10和后V形连接段11的拉动下呈相互远离的张开状态，所述前膜片14和后膜片15的底部相互靠近并固定于所述V形支撑段3底部尖端处。
需要说明的是，单个的前膜片或后膜片的顶部均为上凸圆弧状、下部均为中间有一窄长连接部且两侧配合上凸圆弧的结构，其中窄长连接部的下端与V形支撑段的尖端处固定连接。前后膜片与V形支撑段、第一套管、第二套管及前后翼的连接均优选采用缝合固定的方式。
在本发明的一个实施例中，所述第一限位曲线段6和第二限位曲线段7分别在左右两侧进行的两次交叉中，一个交叉点位于上部且在植入心脏后贴近二尖瓣瓣环的前瓣和后瓣接合处，另一个交叉点位于下部且靠近所述第一套管4或第二套管5的上端。
需要说明的是，在交叉点处不作固定处理，以便心脏收缩时第一和第二曲线段受到前后方向压力时，在交叉点处能够发生错位的微量位移以作为预紧力在心脏舒张时释放，保证第一和第二限位曲线段与瓣环壁贴紧。
在上述各实施例中，如图5所示，所述第一套管4和第二套管5均为三芯管，所述三芯管具有三条沿轴向方向延伸并贯通的固定通道16，三条所述固定通道16呈三角状分布。
需要说明的是，三芯管采用可植入的材料，构成骨架主体的记忆合金丝以一定的顺序依次穿过第一、第二套管的各固定通道，各段长度调节到位后，通过预紧装置在三芯管的外表面施加压力，使其轻微变形达到孔径缩小夹持 住合金丝的目的，纵向上通过摩擦阻力防止位移，因每个固定通道通过一根合金丝，相比于多根合金丝同时通过一个通道，该结构能使每根合金丝外表面与套管的通道内表面的有效摩擦力大大增强，能有效防止合金丝脱出孔外，有利于支架的结构稳定，横向上三个固定通道之间的位置固定而使其内合金丝也无法有横向位移，因此达到较好的定位稳固效果，支架结构更稳定。
在本发明的一个实施例中，所述所述V形支撑段3、第一限位曲线段6、第二限位曲线段7、第三限位曲线段12和第四限位曲线段13由同一根记忆金属丝弯曲绕制后热定型而成，绕制过程中所述记忆金属丝穿过所述第一套管4和第二套管5各自的三条所述固定通道16。
需要说明的是，一根记忆金属丝(合金丝)弯曲绕制(编织)后热定型成型，成型后形态稳定，编织成型过程中使用上述的三芯管定位固定。成型后的骨架结构如图2所示，缝制固定膜组件后的结构如图1所示。手术时整个支架是预压缩于鞘管导管内的，此时两个三芯管(第一及第二套管)并排贴紧，当输送器动作使安装在导管前端的修复支架缓慢释放于心脏内二尖瓣部位时，支架缓慢展开并锚定于二尖瓣部位。
以上所述仅为本发明的较佳实施例，并不用以限制本发明，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 (5)

  1. 一种二尖瓣膜修复支架，其特征在于，包括骨架(1)和膜组件(2)，所述骨架(1)包括上部限位件、中部固定件和下部限位件，所述中部固定件包括V形支撑段(3)及左右对称设置的第一套管(4)和第二套管(5)，所述V形支撑段(3)左右两端分别与所述第一套管(4)和第二套管(5)下端连接，所述膜组件(2)的左侧、右侧及底部依次与所述第一套管(4)、第二套管(5)和V形支撑段(3)连接，所述膜组件(2)顶部的前侧和后侧对应设有前翼(8)和后翼(9)，所述上部限位件包括位于前侧上方的第一限位曲线段(6)和位于后侧上方的第二限位曲线段(7)，所述第一限位曲线段(6)和第二限位曲线段(7)分别在左右两侧进行两次交叉并形成环状部后与所述第一套管(4)和第二套管(5)上端连接，所述第一限位曲线段(6)和第二限位曲线段(7)的中部分别向内凹形成与所述前翼(8)和后翼(9)对应连接的前V形连接段(10)和后V形连接段(11)，所述下部限位件包括位于前侧下方的第三限位曲线段(12)和位于后侧下方的第四限位曲线段(13)，所述第三限位曲线段(12)和第四限位曲线段(13)分别均与所述第一套管(4)和第二套管(5)下端连接。
  2. 根据权利要求1所述的一种二尖瓣膜修复支架，其特征在于，所述膜组件(2)包括彼此分离的前膜片(14)和后膜片(15)，所述前膜片(14)和后膜片(15)顶部对应设有所述前翼(8)和后翼(9)且在所述前V形连接段(10)和后V形连接段(11)的拉动下呈相互远离的张开状态，所述前膜片(14)和后膜片(15)的底部相互靠近并固定于所述V形支撑段(3)底部尖端处。
  3. 根据权利要求1所述的一种二尖瓣膜修复支架，其特征在于，所述第一限位曲线段(6)和第二限位曲线段(7)分别在左右两侧进行的两次交叉 中，一个交叉点位于上部且在植入心脏后贴近二尖瓣瓣环的前瓣和后瓣接合处，另一个交叉点位于下部且靠近所述第一套管(4)或第二套管(5)的上端。
  4. 根据权利要求1至3任一项所述的一种二尖瓣膜修复支架，其特征在于，所述第一套管(4)和第二套管(5)均为三芯管，所述三芯管具有三条沿轴向方向延伸并贯通的固定通道(16)，三条所述固定通道(16)呈三角状分布。
  5. 根据权利要求4所述的一种二尖瓣膜修复支架，其特征在于，所述所述V形支撑段(3)、第一限位曲线段(6)、第二限位曲线段(7)、第三限位曲线段(12)和第四限位曲线段(13)由同一根记忆金属丝弯曲绕制后热定型而成，绕制过程中所述记忆金属丝穿过所述第一套管(4)和第二套管(5)各自的三条所述固定通道(16)。
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