CN108201475A - Artificial valvoplasty ring and suturing method thereof - Google Patents

Artificial valvoplasty ring and suturing method thereof Download PDF

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Publication number
CN108201475A
CN108201475A CN201611179799.0A CN201611179799A CN108201475A CN 108201475 A CN108201475 A CN 108201475A CN 201611179799 A CN201611179799 A CN 201611179799A CN 108201475 A CN108201475 A CN 108201475A
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CN
China
Prior art keywords
end
portion
suture
fabric layer
layer
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Application number
CN201611179799.0A
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Chinese (zh)
Inventor
付明娟
陈文俊
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先健科技(深圳)有限公司
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Priority to CN201611179799.0A priority Critical patent/CN108201475A/en
Publication of CN108201475A publication Critical patent/CN108201475A/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004Means for attaching suture to needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066Needles, e.g. needle tip configurations
    • 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
    • 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
    • A61F2/2409Support rings therefor, e.g. for connecting valves to tissue
    • 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
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • 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
    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008Fixation appliances for connecting prostheses to the body
    • A61F2220/0016Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

The invention discloses an artificial valvoplasty ring. The artificial valvoplasty ring comprises a core tube, a flexible material layer wrapping the core tube, and a fabric layer wrapping the flexible material layer. The fabric layer is of a closed-loop structure, and is provided with two ends which are sutured through suture lines, and each of the two ends is provided with a plurality of annularstructures arranged at intervals; the suture lines sequentially penetrate through the annular structures at the two ends alternately to suture the two ends. The fabric layer of the artificial valvoplasty ring has a small influence on the flow rate of blood flow, and the formation probability of thrombi is also reduced.

Description

人工瓣膜成形环及其缝合方法 Artificial and suture ring annuloplasty

技术领域 FIELD

[0001]本发明涉及心血管医疗器械,尤其涉及一种人工瓣膜成形环及其缝合方法。 [0001] The present invention relates to cardiovascular medical devices, particularly to a prosthetic valve and suture ring shaped.

背景技术 Background technique

[0002]现有的人工瓣膜成形环一般具有三层结构,最内层为金属或高分子材料支撑体, 中间层为娃胶层,最外层是涤纶布管。 [0002] Existing artificial annuloplasty ring having a generally three-layer structure, the innermost layer is a metal or polymer material of the support, the intermediate layer is a subbing layer baby, outermost layer is a polyester fabric tube. 在制备人工瓣膜成形环的过程中,通常是,先将硅胶层套设于支撑体的外表面上,再将涤纶布管套设于硅胶层上,最后将涤纶布管的两端叠合在一起,并用连有缝线的缝针沿涤纶布管的周向一进一出的将涤纶布管两端的叠合之处缝合在一起。 In preparing the artificial annuloplasty ring, usually, the first silicone rubber layer is provided on the outer surface of the sleeve support, polyester fabric then the tube is sleeved on the silicone rubber layer, and finally both ends of the laminated polyester cloth tube together and to a suture into an overlap will at the ends of the tube with a polyester cloth with a circumferential suture needles attached along polyester fabric tube together. 然而,因涤纶布管两端叠合处相对涤纶布管其他之处较厚,且缝线在缝合叠合处时也会形成多个凸起,故,人工瓣膜成形环上的涤纶布表面因缝合涤纶布管两端而形成的凸起相对涤纶布的其他之处较厚,且凸起较多,有较厚且较多凸起的涤纶布不仅会阻碍血流的流动,降低了血流的流速,还增加了涤纶布表面形成血栓的概率。 However, because polyester fabric laminated polyester cloth at both ends of the tube relative to the other of the thicker tube, the suture and the suture at a plurality of protrusions are formed also at the overlapped, therefore, on the surface of polyester cloth artificial annuloplasty ring by other place opposing projections polyester cloth polyester cloth sewn ends of the tube formed thick, and more protrusions, thicker and more convex polyester cloth not only hinder the flow of blood flow, reduced blood flow flow rate, also increases the probability of polyester fabric surface thrombosis.

发明内容 SUMMARY

[0003]本发明要解决的技术问题在于,针对现有技术的缺陷,提供一种人工瓣膜成形环及其缝合方法。 [0003] The present invention is to solve the technical problem that the defects of the prior art, there is provided a prosthetic valve and suture ring shaped.

[0004]本发明解决其技术问题所采用的技术方案是:构造一种人工瓣膜成形环,其包括内核管、包裹于所述内核管外的柔性材料层以及包裹于所述柔性材料层外的织物层,所述织物层为闭环结构,其具有通过缝合线缝合的两端部,每个所述端部均具有多个间隔设置的环状结构,所述缝合线的一端依次交替穿过两所述端部的环状结构以将两所述端部缝合在一起。 [0004] aspect of the present invention to solve the technical problem is: A prosthetic annuloplasty ring structure, which comprises a core pipe, said layer of flexible material wrapped in an outer tube and a core wrapped in an outer layer of the flexible material fabric layer, the fabric layer is a closed loop configuration, having end portions by sutures, each of said end portions each having a plurality of spaced annular structure, one end of the suture through the succession of the two cyclic structure of the end portion to the two end portions are sewn together.

[0005] 优选的,两所述端部的环状结构相对且交替设置。 [0005] Preferably, the cyclic structure and two opposite end portions are alternately disposed.

[0006]优选的,所述成形环上设有标记点,所述织物层两端部的缝合线的位置与所述标记点的位置重合。 [0006] Preferably, the ring shaped marker is provided, and the marker position of the suture end portions of the fabric layer overlap.

[0007]优选的,所述成形环上设有沿所述成形环周向设置的标记线,所述标记线将所述柔性材料层与所述织物层缝合在一起,且与所述内核管相分离。 [0007] Preferably, the shaping is provided along the circumferential direction of the forming ring disposed marking line, the line marking the layer of flexible material are stitched together with the fabric layer, and the core tube phases were separated.

[0008] 优选的,该人工瓣膜成形环的横截面包括第一部分和与所述第一部分相连的第二部分,所述第一部分的轮廓线呈弧形且具有第一端点和第二端点,所述第二部分的轮廓线包括与所述弟一'点相连且向远罔所述第一部分方向延伸的第一段、和自所述第一段远离所述第一端点的端部弯折且朝所述第二端点延伸并与所述第二端部相连的第二段; [0008] Preferably, the artificial annuloplasty ring cross section comprises a first portion and a second portion connected to said first portion, the contour of the arcuate first portion and having a first end and a second end, said second portion connected to said contour line comprises a brother 'point and extend toward the first portion away indiscriminately direction of the first section, and an end portion bent away from the first segment of the first endpoint folding and extending the second section connected to the second end portion toward the second end;

[0009]所述第一部分的轮廓线的过所述第一端点的切线、所述第一部分轮廓线的过所述第二端点的切线及所述第一段围成一个三角形,且所述三角形中,所述第一部分轮廓线的过所述第一端点的切线与所述第一段之间的夹角为锐角,所述第二段与所述第一部分轮廓线的过所述第二端点的切线重合[0010] 优选的,所述内核管由金属或高分子材料制成。 [0009] The contour of the first portion through the first end of the tangent line, the first portion of the contour tangent through the first section and a second end surrounded by a triangle, and the triangle, the angle between the first portion through the first contour line tangent to the end of the first segment is at an acute angle, said second section and through the second portion of the first contour tangent coincident two endpoints [0010] preferably, the core tube made of metal or a polymer material.

[0011] 优选的,所述柔性材料层为硅胶层。 [0011] Preferably, the flexible material layer is a layer of silica gel.

[0012] 优选的,所述织物层为涤纶布。 [0012] Preferably, the fabric layer is a polyester fabric.

[0013] 本发明解决其技术问题采用的另一技术方案是:提出一种如上述所述的人工瓣膜成形环的缝合方法,其包括以下步骤: [0013] Another aspect to solve the technical problems of the present invention is: to provide a prosthetic valve sewing ring on the above-described molding, comprising the steps of:

[0014] S1、提供一瓣环半成品,所述瓣环半成品包括非封闭的内核管以及包裹于所述内核管外周的柔性材料层;所述内核管的其中一端部内容置有连接件,所述连接件自所述端部露出; [0014] S1, providing a semi-finished ring, said semifinished product comprises a non-closed annulus of flexible material layer and the core pipe wrapped on the outer periphery of the core tube; wherein an end portion of the core tube is placed content connecting member, the said connecting member is exposed from the end portion;

[0015] S2、提供一管材和织物层,所述管材具有尾部以及头部,将所述瓣环半成品的具有所述连接件的端部从所述管材的尾部推入,所述管材的头部从所述织物层的一端进入所述织物层的内部; [0015] S2, and a fabric layer provides a tubing, the tubing having a head and a tail, the end portion of the connecting member having the semi-finished product from the end annulus of the tubing pushed the tubing head access to the interior portion of the fabric layer from one end of the fabric layer;

[0016] S3、移动所述织物层,使所述织物层与所述管材做相对运动,直至所述织物层的一端靠近所述管材的尾部,此时将所述管材全部从所述织物层中抽出,使所述织物层与所述柔性材料层贴合; [0016] S3, movement of the fabric layer, the fabric layer and the pipe relative movement, until the end of the fabric layer adjacent to the tail pipe, all this time the tube from the fabric layer extracted, and the fabric layer bonded to the flexible material layer;

[0017] S4、将所述织物层远离所述尾部的端部回折,直至将所述连接件露出; [0017] S4, the fabric layer remote from the end portion of the tail is folded back until the connecting member is exposed;

[0018] S5、将所述内核管的两端对接并通过连接件固定形成对接处; [0018] S5, the abutment ends of the core tube and is formed by a butt joint connector is fixed;

[0019] se、将所述织物层回折的所述端部摊平并覆盖住所述内核管的对接处; [0019] se, will flatten the end portion of the folded back fabric layer and covers the butt joint of the core tube;

[0020] S7、将缝合线的一端依次从所述织物层两端部的环状结构中交替穿过,并拉紧所述缝合线。 [0020] S7, one end of the suture through the succession of the cyclic structure of the both end portions of the fabric layer, and tensioning the suture.

[0021] 优选的,该缝合方法还包括所述标记线的缝合方法,所述标记线的缝合方法包括以下步骤: [0021] Preferably, the method further comprising stitching the suturing method according to the marking line, the marking line stitching method comprising the steps of:

[0022] 1)、将连接有缝合线的缝合针的一端从所述织物层扎入,避开所述内核管,并依次穿过所述织物层和柔性材料层; [0022] 1), is connected to one end of the suture needle from the suture tie into the fabric layer, to avoid the core tube and passes through the fabric layer and the flexible material layer;

[0023] 2)、所述缝合针的一端自所述织物层穿出后,先调整所述缝合针另一端的角度,再推动所述缝合针自所述缝合针一端穿出的位置扎入,并使其朝所述缝合针另一端所指的方向移动,避开所述内核管并依次穿过所述柔性材料层和织物层,直至所述缝合针全部露出。 [0023] 2), from one end of the needle after piercing the fabric layer, to adjust the angle of the other end of said suture needle, and then pushing the suture needle from the needle end of the bar into the piercing position and allowed direction towards the other end of the suture needle indicated movement, avoiding the core tube and passes through the flexible material layer and a fabric layer, until all of the needle is exposed. [0024] 3)、重复步骤1)和步骤2)完成所述标记线的缝合。 [0024] 3) Repeat steps 1) and 2) the label is completed suture line.

[0025]优选的,所述缝合针的针尾呈锥形,且步骤2)中所述锥形的针尾从所述织物层扎入。 [0025] Preferably, the needle end of the suture needle is tapered and step 2) the tapered needle end of the tie from the fabric layer.

[0026]优选的,所述缝合针的角度在所述柔性材料层内调整。 [0026] Preferably, the angular adjustment of the needle within the flexible material layer.

[0027]优选的,该人工瓣膜成形环的横截面包括第一部分和与所述第一部分相连的第二部分,所述第一部分的轮廓线呈圆弧形且具有第一端点和第二端点,所述第二部分的轮廓线包括与所述第一端点相连且向远离所述第一部分方向延伸的第一段、和自所述第一段远离所述第一端点的端部弯折且朝所述第二端点延伸并与所述第二端部相连的第二段; [0027] Preferably, the cross-section of the artificial annuloplasty ring comprises a first portion and a second portion connected to the first portion, the first portion of the contour line and the circular arc having a first and second end points said second portion comprising a contour line connected to said first end and away from the first portion to a first segment extending in a direction, and an end portion bent from the first section away from the first endpoint folding and extending the second section connected to the second end portion toward the second end;

[0028]所述第一部分的轮廓线的过所述第一端点的切线、所述第一部分轮廓线的过所述第二端点的切线及所述第一段围成一个三角形,且所述三角形中,所述第一部分轮廓线的过所述第一端点的切线与所述第一段之间的夹角为锐角,所述第二段与所述第一部分轮廓线的过所述第二端点的切线重合。 [0028] The contour of the first portion through the first end of the tangent line, the first portion of the contour tangent through the first section and a second end surrounded by a triangle, and the triangle, the angle between the first portion through the first contour line tangent to the end of the first segment is at an acute angle, said second section and through the second portion of the first contour tangents coincide with two endpoint.

[0029]优选的,该缝合方法还包括所述标记点的缝合方法,其具体包括以下步骤: [0029] Preferably, the method further comprising the step of suturing the suture marker points, which comprises:

[0030]①、所述缝合针从所述第一部分与所述第二部分相连处扎入,避开所述内核管并完全穿过所述织物层以及所述柔性材料层,围绕所述第一部分的外轮廓回到所述相连处; [0030] ①, said needle from said first portion and said second portion is connected into the bar, and avoiding the core tube completely through the fabric layer and said layer of flexible material around the first back to the outer contour of a portion connected at;

[0031]②、所述缝合针从所述相连处扎入并穿过所述织物层和柔性材料层,围绕所述第二部分的外轮廓并回到所述相连处。 [0031] ②, the suture needle is connected to the tie from the fabric into and through the layer and the layer of flexible material around the outer contour of said second portion and is connected at the back.

[0032] 优选的,所述连接件为镍钛套管。 [0032] Preferably, the connecting member is a nickel-titanium sleeve.

[0033]相较现有的缝合方式,不仅未将织物层的两端叠合在一起,而且缝合处由于一个端部的环状结构能够伸入到另一个端部相邻的两个环状结构之间而更加平整,产生的凸起较薄也较少,因此通过该方法获得人工瓣膜成形环的织物层不仅对血流的流速影响较小, 也降低了血栓的形成概率。 [0033] Compared to conventional stitching, not only at both ends of the fabric layers laminated together, and a suture end portion of the annular structure can extend into the other ends of two adjacent annular between structures more smooth, and less thin projections generated, thereby obtaining a prosthetic valve through which the ring shaped cloth layer not only less effect on blood flow velocity also reduces the probability of thrombi formation.

附图说明 BRIEF DESCRIPTION

[0034] 下面将结合附图及实施例对本发明作进一步说明,附图中: [0034] The accompanying drawings and the following embodiments of the present invention is further illustrated drawings in which:

[0035]图1是本发明一种人工瓣膜环优选实施例的结构示意图; [0035] FIG. 1 is a schematic view of a prosthetic valve ring is preferably an embodiment of the present invention;

[0036]图2是图1所示的人工瓣膜环沿图1中AA方向的剖面图; [0036] FIG. 2 is a sectional view in the direction AA of FIG. 1 along the prosthetic valve ring shown in Figure 1;

[0037]图3是图1所示的人工瓣膜环中织物层两端部未被缝合时的结构示意图; [0037] FIG. 3 is a schematic view of both end portions of the prosthetic valve in the annulus fabric layer shown in FIG. 1 is not sewn;

[0038]图4是图1所示的人工瓣膜环中织物层两端部缝合过程中的结构示意图; [0038] FIG. 4 is a schematic structural diagram of both ends of the loop fabric layer suturing of the prosthetic valve shown in FIG 1;

[0039]图5是图1所示的人工瓣膜环中织物层两端部缝合完的结构示意图; [0039] FIG. 5 is a schematic structural diagram of a prosthetic valve in the annulus at both ends fabric layer shown in FIG. 1 finished suture;

[0040]图6是图1所示的人工瓣膜环中织物层两端部未被缝合时另一实施例的示意图; [0041]图7是本发明一种人工瓣膜成形环的缝合方法步骤S1中提供的瓣环半成品的结构不意图; [0040] FIG. 6 is a schematic diagram of another embodiment of the prosthetic valve when both ends of the loop fabric layer is not shown in FIG suture; [0041] FIG. 7 is a method of the present invention is an artificial suture annuloplasty ring step S1 structure annulus semifinished product is not intended to provide;

[0042]图8是本发明的人工瓣膜成形环的缝合方法步骤S2的操作示意图; [0042] FIG. 8 is a schematic diagram illustrating the suture ring method step S2 of forming the prosthetic valve according to the present invention;

[0043]图9-图11是本发明的人工瓣膜成形环的缝合方法步骤S3的操作示意图; [0043] Figure 9 is a schematic diagram illustrating the FIG. 11 process steps suture ring of the prosthetic valve according to the present invention, S3 is formed;

[0044]图12是本发明的人工瓣膜成形环的缝合方法步骤S4和步骤S5的操作示意图; [0044] FIG. 12 is a schematic view of the operation of the prosthetic valve according to the present invention, the step of forming the ring suture S4 and step S5;

[0045]图13是本发明的人工瓣膜成形环的缝合方法步骤S6的操作示意图; [0045] FIG. 13 is a schematic view of the operation of the suture ring of the prosthetic valve in step S6 of forming the present invention;

[0046]图14是图13中B部位的放大图; [0046] FIG. 14 is an enlarged portion of FIG. 13 B;

[0047]图15是本发明的标记线缝合方法中提供的缝合针的结构示意图; [0047] FIG. 15 is a schematic view of the line marking needle suture method according to the invention provided;

[0048]图16-图20是采用本发明的标记线缝合方法的缝合过程示意图; [0048] FIG 16- FIG 20 is a marking process using suture stitching method of the invention; and FIG.

[0049]图21是采用本发明的标记线缝合方法缝合完之后的结构示意图; [0049] FIG. 21 is a schematic view of the structure after use of the suture marking method according to the invention finish suture;

[0050]图22是采用本发明的一种标记点缝合方法的操作示意图; [0050] FIG. 22 is a schematic diagram of operating a suture marker of the present invention employs;

[0051]图23是采用图22所示的缝合方法缝合标记点的过程示意图。 [0051] FIG. 23 is a schematic view of the suture during use of the marker 22 shown in FIG suture.

具体实施方式 Detailed ways

[0052] 为了对本发明的技术特征、目的和效果有更加清楚的理解,现对照附图详细说明本发明的具体实施方式。 [0052] For the technical characteristics of the invention, the objects and effects more clearly understood, embodiments of the present invention will now be explained in detail with reference to the drawings.

[0053]如图1和图2所示,一种人工瓣膜成形环1〇包括内核管11、包裹于内核管11外周的柔性材料层12以及包裹于柔性材料层12外的织物层13。 [0053] As shown in FIG. 1 and FIG. 2, A prosthetic annuloplasty ring comprising 1〇 core tube 11, the outer periphery of the core 11 wrapped in a tube of flexible material wrapped in the fabric layer 12 and outer layer 13 of flexible material layer 12. 人工瓣膜成形环10为一具有柔性的非平面环体,内核管11由金属或高分子材料制成,柔性材料层12优选硅胶,织物层I3优选涤纶布。 Artificial annuloplasty ring 10 is a ring having a non-planar flexible member, core tube 11 made of a metal or polymer material, preferably silicone layer of flexible material 12, preferably polyester cloth fabric layer I3. 此外,人工瓣膜成形环10上还设有沿成形环10周向设置的标记线14以及间隔设置在成形环10上的左三角标记点15、右三角标记点16以及后标记点17。 In addition, artificial annuloplasty ring 10 is also provided along the ring shaped marker 10 disposed circumferentially and left triangular marker 14 is provided on the spacer ring 10 forming 15, 16 and a right rear triangular marker 17 marker.

[0054]如图3-图5所示,织物层13为一封闭的编织环状结构,其具有通过缝合线I8缝合的两端部131和132。 [0054] As shown in FIG. 3 to FIG. 5, the fabric layer 13 is woven as a closed annular structure, having both ends of the suture 131 and suture 132 I8. 两端部131和132分别具有若干个间隔设置的环状结构131A和132A。 Both end portions 131 and 132 each have a plurality of spaced annular structure 131A and 132A. 由于织物层13为编织物,因此环状结构131A和132A为其自身的一部分,且在本优选实施例中,环状结构131A和132A相对且交替设置。 Since the fabric layer is a knitted fabric 13, so cyclic structure portion 131A and 132A of its own, and embodiments, the cyclic structure 131A and 132A are alternately disposed opposite and in the preferred embodiment. 所述相对且交替设置是指,若干个环状结构131A与若千个环状结构132A相对,且当两端部131和132对齐时,每两个相邻的环状结构131A之间有且仅有一个环状结构132A,每两个相邻的环状结构132A之间有且仅有一个环状结构131A。 And alternately disposed relative to said means, and a plurality of annular structure, if the relative 131A, and when both end portions 131 and 132 are aligned, there are between two adjacent ring structures 131A and 132A cyclic structure one thousand only a cyclic structure 132A, there is one and only one cyclic structure 131A between every two adjacent ring structure 132A. 缝合线18依次交替穿过环状结构131A和132A,最后再拉紧缝合线18完成缝合。 18 are alternately passed through the suture ring structure 131A and 132A, 18 finally complete the suture tensioning suture.

[0055] 环状结构131A和132A相对交替设置使得缝合线18在拉紧后,其中一个端部的环状结构能够伸入到另一个端部相邻的两个环状结构之间,这种缝合方式相较现有的缝合方式,不仅未将织物层的两端叠合在一起,而且缝合处由于一个端部的环状结构能够伸入到另一个端部相邻的两个环状结构之间而更加平整,产生的凸起较薄也较少,因此通过该方法获得人工瓣膜成形环的织物层不仅对血流的流速影响较小,也降低了血栓的形成概率。 [0055] The cyclic structure 131A and 132A are alternately disposed opposite such that the suture 18 taut, wherein one end portion of the ring structure can be between two ring structures extending into the adjacent end of the other, this compared with conventional suture stitching, not only at both ends of the fabric layers laminated together, and a suture end portion of the annular structure of the two ring structures capable of extending into the adjacent end of the other between the more smooth, and less thin projections generated, thereby obtaining a prosthetic valve through which the ring shaped cloth layer not only less effect on blood flow velocity also reduces the probability of thrombi formation. [0056]如图6所示,在其他可能的实施例中,两个端部的若干个环状结构131A'和132A'的位置也可以是一一对应的。 [0056] As shown in FIG 6, in other possible embodiments, a plurality of end portions of the two cyclic structures 'and 132A' positions 131A may be one to one. 由于缝合线18' 一端依次从织物层两端部的环状结构中交替穿过,因此拉动缝合线I8',图6中所示的一个环状结构132A'在缝合线18'的牵引下被拉入两个相邻的环状结构132A'中间。 Since the suture 18 'are alternately through one end of both end portions of the structure from the annular fabric layer, thus pulling suture I8', a cyclic structure 132A shown in FIG. 6 is "suture 18 'of traction two adjacent ring pull structure 132A 'middle. 这样所获的缝合处也由于一个端部的环状结构能够伸入到另一个端部相邻的两个环状结构之间而更加平整,产生的凸起较薄也较少。 Such a suture is also obtained because a cyclic structure can be an end portion extending into an annular configuration between the two portions adjacent the other end and more smooth, thin protrusions generated less.

[0057] 进一步的,在本发明的优选实施例中,缝合线18的位置与上述三个标记点中的其中一个重合并隐藏在该标记点下面。 [0057] Further, in the embodiment, the position of the suture 18 and the above-described three marker points wherein a combined weight of the marker hidden beneath the preferred embodiment of the present invention. 将缝合线18的位置隐藏在其中一个标记点下面可以进一步减少瓣膜环表面的不平整处,在降低血栓形成概率的同时,使得瓣环更加美观。 The position of the suture 18 is hidden in one of the following marker may further reduce the unevenness of the ring surface of the valve, while reducing the probability of thrombosis, such that the annulus more beautiful.

[0058] 如图2所示,该成形环10的横截面包括第一部分1〇1和与第一部分1〇1相连的第二部分102。 [0058] As shown in FIG. 2, the cross-section of the ring 10 comprises a first portion 1〇1 shaped and connected to the first portion of the second portion 102 1〇1. 第一部分101的轮廓线呈圆弧形且具有第一端点101A和第二端点101B。 The first portion 101 of circular arc contour line having a first end and a second end 101A and 101B. 第二部分102的轮廓线具有与第一端点101A相连的且向远离所述第一部分101方向延伸的第一段l〇2A,和自第一段102A远离第一端点101A的端部弯折且朝第二端点101B延伸并与第二端点101B相连的第二段l〇2B。 A second portion having a contour line 102 and away from the first section l〇2A, and a bent end portion 101 extending toward a first direction and a first end portion 101A connected to the first segment 102A away from the first end 101A of folding and extending in a second segment of the second terminal 101B and 101B and the second endpoint l〇2B connected. 其中,第一部分1〇1轮廓线的过第一端点i〇ia的切线、第一部分101 轮廓线的过第二端点101B的切线及第一段l〇2A围成一个三角形,且该三角形中,第一部分101轮廓线的过第一端点101A的切线与第一段102A之间的夹角为锐角;第二段102B与第一部分101轮廓线的过第二端点101B的切线重合。 Wherein the first portion through the first end tangent 1〇1 i〇ia contour line, the first portion 101 through the second end 101B of the contour tangent l〇2A first section and form a triangular and the triangle , the angle between the first portion 101A through the first end 101 tangent to the contour line at an acute angle to the first segment 102A; 102B second section through the second end portion 101 of the first contour line coincides with a tangent line 101B.

[0059]标记线14自第一端点101A和第一段102A相连处穿入织物层13和柔性材料层12并避开内核管11,从而将织物层13和柔性材料层12缝合固定。 [0059] The marking line 14 from the first end 101A and 102A connected to the first segment 13 to penetrate the fabric layer and the flexible material layer 12 and away from the core tube 11, so that the fabric layer 13 and the flexible suture material layer 12. 此时,标记线14与柔性材料层12 的相对位置是固定的,且位于第一端点101A和第一段102A相连处。 In this case, the relative position of the marking line 14 and the flexible material layer 12 is fixed, and is located between the first end 101A and 102A are connected at the first segment. 标记线14与柔性材料层12的相对位置固定使得医生在手术操作过程中不会因为织物层丨3与柔性材料层丨2之间的相对滑动而戳到内核管11,避免了手术失败,提高了手术的成功率。 Marking line 14 and the relative position of the flexible material layer 12 is fixed so that the doctor will not Shu fabric layer 3 and the relative sliding between two layers of flexible material and poked Shu core tube 11 during the surgical procedure, to avoid the failure of the operation, to improve the success rate of surgery.

[0060]本发明还提出了一种上述人工瓣膜成形环的缝合方法,该方法包括以下步骤: [0061^ S1、如图7所述,提供一瓣环半成品20。 [0060] The present invention also provides a method of suturing the above-described artificial annuloplasty ring, the method comprising the steps of: [0061 ^ S1, FIG. 7, there is provided a semi-finished ring 20. 该瓣环半成品20包括非封闭的内核管21以及包裹于内核管21外周的柔性材料层22。 The annulus 20 comprises a non-closed semifinished core tube 21 and a flexible layer of material 21 wrapped on the outer periphery of the core tube 22. 内核管21为空心的管状结构,且内核管21其中一端部内容置有连接件23,该连接件M自内核管21的端部露出。 Core tube 21 is a hollow tubular structure, and wherein an end portion of the core tube 21 accommodates therein the connector 23, the connecting member M from the end portion of the core tube 21 is exposed. 在本优选实施例中,连接件23 为镍钛管。 In the preferred embodiment, the connecting member 23 is a nickel-titanium tubing.

[0062] S2、如图8所示,提供一管材3〇和管状的织物层24。 [0062] S2, shown in Figure 8, there is provided a fabric layer 24 and the pipe 3〇 tubular. 管材3〇具有尾部31以及锥形的头部32。 3〇 pipe 31 having a tail 32 and a tapered head. 织物层24具有管材进入端241。 Having a fabric layer 24 into the pipe end 241. 将瓣环半成品20的具有连接件23的端部从管材30的尾部31开口处推入管材3〇内部,且瓣环半成品20的远离连接件23的端部裸露在外,再将管材30的头郃32经织物层24的管材进入端241推入织物层24的内部。 The annulus portion semifinished product having a connector end 23 of the pipe 30 from the end 20 of the opening 31 of the inner pipe pushed into 3〇 and semi annulus remote from the connecting end 23 of the exposed portion of member 20, the head 30 of the pipe and then 32-he fabric layer 24 through the pipe 241 is pushed into the end 24 of the inner fabric layer. 管材30的表面光滑,且其头部32被设计成锥形,以有利于进入织物层24的内部。 Smooth surface of the pipe 30, and the tapered head portion 32 is designed to facilitate access to the interior 24 of the fabric layer.

[0063] S3、如图9所示,移动织物层24的管材进入端241,使织物层24与管材30做相对运动,直至将织物层24的管材进入端241靠近管材30的尾部31。 [0063] S3, shown in Figure 9, the pipe 24 moves into the end of the fabric layer 241, fabric layer 24 and the tube 30 for relative movement, until the pipe 24 into the fabric layer 241 near the aft end 30 of the pipe 31. 如图10所述,当管材30露出其头部32时,拉动管材3〇,直至将管材30全部从织物层24中抽出。 As shown in Figure 10, the pipe 30 is exposed when the head 32, pulling the tubing 3〇, until all tubes 30 is withdrawn from the fabric layer 24. 如图u所示,此时,织物层24 的内壁面与柔性材料层22的外壁面贴合。 As shown in FIG u, At this time, the outer wall surface of the inner wall surface of the flexible material layer 24 of the fabric layer 22 bonded.

[0064] S4、如图12所示,将织物层24靠近连接件23的端部回折,直至将连接件23露出。 [0064] S4, shown in Figure 12, the fabric layer 24 near the connecting end portion 23 folded back, until the connector 23 is exposed.

[0065] S5、将内核管21的两端对接并通过连接件23焊接固定形成对接处。 [0065] S5, the abutment ends 21 and the core tube fixing member is formed by connecting the abutment 23 welded.

[0066] S6、如图13和图14所示,将织物层24回折的端部摊平并覆盖住内核管21的对接处。 [0066] S6, 13 and 14, the fabric layer 24 is folded back to cover an end portion abutting the smoothing and live core tube 21.

[0067] S7、将缝合线的一端依次从织物层24两端部的环状结构中交替穿过(参阅图4)。 [0067] S7, one end of the suture in order from both ends of the annular structure 24 are alternately through the fabric layer (see FIG. 4). 再拉紧缝合线的两端,并将缝合线的两端打结成一体,打结后的缝合线的端部隐藏于织物层24与柔性材料层22之间,如此,完成缝合。 Re-tensioning of the suture ends, the suture ends and the play integrally formed, the rear end portion of the suture knot hidden in between the fabric layer 24 and flexible material layer 22, thus, complete the suture.

[0068] 本发明中,所述缝合线的一端依次从织物层24两端部的环状结构中交替穿过可以通过以下多种方式完成:方式一,缝合线的一端可以依次从从右至左数的第一个环形结构131A、从右至左数第一个环状结构132A、从右至左数第二个环状结构131A、从右至左数第二个环状结构132A、从右至左数第三个环状结构131A、从右至左数第三个环状结构132A…… 穿过,直至缝合线的端部从右侧的最后一个环状结构穿出;方式二,缝合线的一端可以依次从从左至右数的第一个环形结构13从、从左至右数第一个环状结构131A、从左至右数第二个环状结构1:32A、从左至右数第二个环状结构131A、从左至右数第三个环状结构132A、从左至右数第三个环状结构131A……穿过,直至缝合线的端部从右侧的最后一个环状结构穿出。 [0068] In the present invention, one end of the suture in order from both ends of the annular structure 24 are alternately through the fabric layer can be accomplished by several ways: First, one end of the suture may be sequentially from the right to the manner the first ring 131A of the left, from left to right a cyclic structure 132A, the second from right to left cyclic structure 131A, the second from right to left cyclic structure 132A, from third from right to left cyclic structure 131A, third from right to left ...... cyclic structure 132A through until the end of the suture out through the right side of the last ring structure; mode 2 one end of the suture may be sequentially from the first number ring 13 from left to right, from left to right, the number of the first ring structure 131A, the second from left to right the number of ring structure 1: 32A, from the second number of cyclic structure 131A left to right, from left to right, the number of the third cyclic structure 132A, the third from the left to right the number of ring structures 131A ...... through, until the right end portion of the suture Finally, a cyclic structure of the piercing side.

[0069]该缝合方法中,缝合线的一端依次从织物层两端部的环状结构中交替穿过,待拉紧缝合线两端后,其中一个端部的环状结构能够伸入到另一个端部相邻的两个环状结构之间,这种缝合方式相较现有的缝合方式,不仅未将织物层的两端叠合在一起,而且缝合处由于一个端部的环状结构能够伸入到另一个端部相邻的两个环状结构之间而更加平整,产生的凸起较薄也较少,因此通过该方法获得人工瓣膜成形环的织物层不仅对血流的流速影响较小,也降低了血栓的形成概率。 After [0069] the suturing method, one end of the suture through the succession of the cyclic structure of the fabric layer in both end portions, both ends of the suture to be tensioned, wherein the cyclic structure of one end portion projecting into the other can be between two adjacent cyclic structure of one end portion, which compared to conventional suture stitching, not only at both ends of the fabric layers laminated together, and a suture due to the cyclic structure of the end portion can be between two ring structures extending into the other end portion adjacent to and more smooth, and less thin projections generated, thus forming a ring fabric layer obtained by this method is not only artificial valve flow velocity of the blood flow less affected, but also reduces the probability of thrombus formation. 该人工瓣膜成形环的缝合方法还进一步包括标记线的缝合方法和标记点的缝合方法。 This artificial suture annuloplasty ring further comprising a suture and suture marker marking line. 其中标记线的缝合方法包括以下步骤: Wherein the suture line marking comprises the steps of:

[0070] 1)、如图15所示,提供一缝合针40,该缝合针40具有针尖41、与针尖41相对的针尾43。 [0070] 1), as shown in Figure 15, there is provided a suture needle 40, the needle 40 having a needle tip 41, the needle tip 41 opposite the end of the needle 43. 针尾43具有针尖的功能,其设有一个穿线孔似。 End of the needle tip 43 has the function of which is provided with a threaded hole like. 本实施例中,针尾43呈锥形。 In this embodiment, the needle 43 is tapered tail. 穿线孔42可收容缝线,即缝线可经穿线孔42与针尾43相连。 Threading a suture receiving holes 42 may be, i.e., the suture can be connected via hole 42 and the needle threading tail 43.

[0071] 2)、如图16和图I7所示,将连有缝线5〇的缝合针40的针尾43从织物层24的顶面241 扎入,避开内核管21,并依次穿过织物层24的顶面241和柔性材料层22。 [0071] 2), as shown in FIGS. 16 and I7, the end of the suture with a needle attached to the suture needle 40 5〇 43,241 pierce the fabric layer from the top surface 24 of tube 21 away from the core, and in turn wear through the top surface 241 of fabric layer 24 and the layer 22 of flexible material.

[0072] 3)、如图18-20所示,缝合针40的针尾43自织物层24的底面242穿出后,先调整缝合针40针尖41的角度,再推动缝合针40自织物层24上针尾43穿出的位置S扎入,并使其朝针尖41所指的方向移动,避开内核管21并依次穿过柔性材料层22和织物层24,直至缝合针40全部露出。 [0072] 3), 18-20, the rear end of the bottom surface of the needle from the needle 40 of the fabric layer 43 24 242 piercing, to adjust the angle of the suture needle 40 of the needle 41, and then push the needle 40 from the fabric layer 24 43 piercing end of the needle bar into the position S and allowed to move away from the core passes through the tube 21 and flexible material layer 22 and the fabric layer 24 in the direction of the needle tip 41 is referred to, until all of the needle 40 is exposed. t〇〇73] 4)、如图21所示,重复步骤2)和步骤3)即可完成标记线的缝合。 t〇〇73] 4), shown in Figure 21, repeating steps 2) and 3) to complete the suture marking line.

[0074]可以理解的是,其他实施例中,步骤2中也可以针尖41从织物层24的顶面241扎入, 避开内核管21,并依次穿过织物层24的顶面241和柔性材料层22,此种情况下,待缝合针40 的针尖41自织物层24的底面242穿出后,先调整缝合针40针尾43的角度,再推动缝合针40自织物层24上针尖41穿出的位置S扎入,并使其朝针尾41所指的方向移动,避开内核管21并依次穿过柔性材料层22和织物层24,直至缝合针40全部露出,也可以完成标记线的缝合。 [0074] It will be appreciated that other embodiments, in step 2 may pierce the needle tip 41 from the top surface 241 of fabric layer 24, away from the core tube 21, and passes through the top surface 24 of fabric layer 241 and flexible material layer 22, in this case, until the needle tip 41 from the bottom surface 40 of fabric layer 24 of the piercing post 242, to adjust the angle of the suture needle 40 pin tail 43, and then pushing the fabric layer 40 needle 24 from needle tip 41 S pierce the piercing position, and moved towards the end of the needle 41 within the meaning of, and away from the core tube 21 passes through the flexible material layer 22 and the fabric layer 24, until the entire needle 40 is exposed, can be completed flag suture.

[0075] 由图21可以看到,采用上述方法缝合的标记线,缝合线并未将织物层24的底面242 与柔性材料层22缝合,缝合线在织物层24的顶面241与柔性材料层22之间穿插。 [0075] It is seen from FIG. 21, the above-described method of line marking the suture, the suture 24 does not bottom surface 242 of the fabric layer 22 with the suture, the suture layer of flexible material on the top surface 241 of the fabric layer 24 and the layer of flexible material 22 interspersed between. 由于缝合线的拉紧作用以及柔性材料层22的材料特性,织物层24的被缝合针40穿过的位置以及相邻的该位置之间会不可避免的产生小的凹陷,而采用上述缝合方式的好处是,底面242上不存在这样的凹陷,就能最大限度地减少织物层表面的不平整和凸起,降低了血栓发生的概率。 Due to the small recess inevitably generated between material properties and the tightening action of the flexible suture material layer 22 are stitched fabric layer 24 of the needle 40 and passes through a position adjacent to the position, and the above-described suture the advantage is that the absence of such a recess 242 on the bottom surface, can minimize the uneven surface of the fabric layer and projections, reduces the probability of thrombosis. 此外,采用上述方法缝合的标记线与柔性材料层22缝合在一起,且缝合线避开了内核管21,医生在手术时,缝合针在缝合线的指引下,不会戳到内核管21,提高了手术的安全有效性。 Further, the above-described method of suturing the suture line marking flexible material layer 22 together and the suture away from the core tube 21, the doctor during surgery, under the guidance of the suture needle of the suture, not poke the core tube 21, improving the safety and effectiveness of surgery. [0076] 当完成织物层两端的缝合后,可以在织物层上继续缝制标记点,而标记点的缝合包括以下步骤: [0076] After completion of suturing both ends of the fabric layers, may continue to sew marked points on the fabric layer stitched marker comprises the steps of:

[0077] ①、请参阅图22,缝合针40从成形环横截面上的第一段102A与第一端点101A的相连处扎入,避开内核管21并完全穿过织物层24以及柔性材料层22,顺时针围绕第一部分101 的外轮廓回到第一段102A与第一端点101A相连处。 [0077] ①, see FIG. 22, the needle 40 from the ring shaped cross section of the first section 102A is connected at a first end 101A of the bar, avoiding the core 21 and completely through the tube 24 and a flexible fabric layer material layer 22, clockwise around the outer contour of the first portion 101 of first section 102A and the back is connected at a first end 101A.

[0078] ②、缝合针40从第一段102A与所述第一端点101A相连处扎入并穿过织物层24和柔性材料层22,逆时针围绕第二部分102的外轮廓并回到第一段102A与第一端点101A的相连处。 [0078] ②, the needle 40 from the first section 102A is connected at a first end 101A and pierce through the fabric layer 24 and flexible material layer 22, counter-clockwise around the outer contour of the second portion 102 and back to first section 102A and 101A is connected at a first end.

[0079] ③、将缝合线的两端打结,并将结头隐藏至织物层24里面。 [0079] ③, both ends of a suture knot, and the knot 24 to hide the inside fabric layer.

[0080]可以理解的是,其他实施例中,若从成形环横截面上的第二段102B与第二端点101B相连处入针,则避开内核管21并完全穿过织物层24以及柔性材料层22,逆时针围绕第一部分101的外轮廓回到第二段102B与第二端点101B相连处;再从第二段102B与第二端点101B相连处入针,并穿过织物层24和柔性材料层22,顺时针围绕第二部分102的外轮廓并回到第二段102B与第二端点101B相连处;最后将缝合线的两端打结,并将结头隐藏至织物层24里面,也能形成标记点。 [0080] It will be appreciated that other embodiments, when connected to the ring shaped cross section from a second section 102B and 101B at a second end into the needle, the tube 21 away from the core layer 24 and completely through the fabric and a flexible material layer 22, counter-clockwise around the outer contour of the first portion 101 of the back end second section 102B and 101B connected to the second; and then the needle 101B is connected from the second segment and the second endpoint 102B, and through the fabric layer 24 and the flexible material layer 22, clockwise around the outer contour of the second portion 102 and back to the second segment 102B and 101B connected to the second end; and finally both ends of the suture knot, and the knot 24 inside fabric layer to hide , the marker can be formed.

[0081] 如图23所示,还可以理解的是,其他实施例中,三个标记点及标记线之间还可以通过一次打结来完成,例如可以先采用上述标记线的缝合方法缝合标记线直至第一标记点处,然后采用与上述标记点的缝合方法大体上类似的方法缝合第一个标记点(当然,此时缝合第一个标记点时无需打结),待第一个标记点缝完之后继续采用上述标记线的缝合方法缝合标记线直至第二个标记点处,然后采用与上述标记点的缝合方法大体上类似的方法缝合第二个标记点(当然,此时缝合第二标记点时无需打结),接着再采用上述标记线的缝合方法缝合标记线直至第三个标记点处(当然,此时缝合第一个标记点时无需打结),待第三个标记点缝完之后继续采用上述标记线的缝合方法缝合标记线直至与标记线的另一端头汇合而打结结合在一起,如此,完成了标记线及 [0081] 23, also it is appreciated that other embodiments, between the three markers and marking lines can also be accomplished by one knot, for example, be employed to suture the suture line marking the marker the line until the first marker, and then use the mark substantially suture point method similar to the first suture point marker (of course, this time without a first marker knotted suture), the first mark to be continue to use the marker at the point after completing the seam line suture suture until the second marking line marker, and the above-described method using the suture markers methods substantially similar second suture markers (of course, this time the first suture second markers without knotting), followed by the use of the labeling method of the suture line is stitched up to the third marking line marker (of course, this time without a first suture knot marker) to be a third marker continue to use the marker point after completing the seam line suture until the suture line marking head and the other end of the line marking confluence knotted together, thus, completed and the marking lines 记点的一次打结形成过程。 Points in the formation of a knot. 再例如,先缝第一个标记点,但是不打结,接着缝标记线至第二个标记点处,再缝第二个标记点,仍然不打结,接着缝标记线至第三个标记点处,仍然不打结,接着缝标记线至第一个标记点处,将缝合线的两端在第一个标记点处打结,也可以完成了标记线及三个标记点的一次打结形成过程。 As another example, the first marker to the seam, but no tie, then seam marking lines to a second marker, then second marker seam, still no tie, and then sewn to the third tag marking line point, still no tie, then seam mark a marker line to the first, both ends of the suture knot at the first marker may be a complete marking of the line and the three markers junction formation process.

[0082] 依照上述缝合方法完成一个标记点的缝合后,再依照本发明标记线的缝合方法缝合标记线,当缝合至下一个标记点位置时再依照标记点的缝合方法完成缝合,接着再缝合标记线直至再下一个标记点,如此即可完成人工瓣膜成形环的缝合。 [0082] After completion of suturing a marker in accordance with the above-described suture, and then in accordance with the suture stitched mark line marker of the present invention, when the suture to the next marker position and then complete the suturing accordance suture marker points, followed by suture another marker until the next marker, doing so to complete annuloplasty sewing ring.

[0083]以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对本发明专利范围的限制。 [0083] Expression of the above-described embodiments are only several embodiments of the present invention, and detailed description thereof is more specific, but can not therefore be understood as limiting the scope of the present invention. 应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。 It should be noted that those of ordinary skill in the art, without departing from the spirit of the present invention, can make various changes and modifications, which fall within the protection scope of the present invention. 因此,本发明专利的保护范围应以所附权利要求为准。 Therefore, the protection scope of the present invention should be subject to the appended claims.

Claims (14)

1. 一种人工瓣膜成形环,其包括内核管、包裹于所述内核管外的柔性材料层以及包裹于所述柔性材料层外的织物层,其特征在于,所述织物层为闭环结构,其具有通过缝合线缝合的两端部,每个所述端部均具有多个间隔设置的环状结构,所述缝合线的一端依次交替穿过两所述端部的环状结构以将两所述端部结合在一起。 1. A prosthetic annuloplasty ring, comprising a core tube, an outer layer of flexible material wrapped in the core tube wrapped in the fabric layer and an outer layer of a flexible material, wherein said fabric layer is a closed structure, by having both end portions of sutures, each of said end portions each having a plurality of spaced annular structure, one end of the suture through a cyclic succession of the two ends of the structure to the two said end portions together.
2. 根据权利要求1所述的人工瓣膜成形环,其特征在于,两所述端部的环状结构相对且交替设置。 2. The prosthetic valve according to claim 1 annuloplasty ring, wherein the ring structure and two opposite end portions are alternately disposed.
3. 根据权利要求2所述的人工瓣膜成形环,其特征在于,所述成形环上设有标记点,所述织物层两端部的缝合线的位置与所述标记点的位置重合。 The prosthetic valve according to claim 2, wherein the annuloplasty ring, wherein said ring forming position coinciding with the marker points, both end portions of the suture position of the fabric layer with the marker points.
4. 根据权利要求1所述的人工瓣膜成形环,其特征在于,所述成形环上设有沿所述成形环周向设置的标记线,所述标记线将所述柔性材料层与所述织物层缝合在一起,且与所述内核管相分离。 The prosthetic valve according to claim 1, wherein said annuloplasty ring, characterized in that said layer of flexible material forming the ring is provided with the circumferential direction marker disposed along said forming, the line marking the fabric layers stitched together, and is separated from the core tube.
5. 根据权利要求4所述的人工瓣膜成形环,其特征在于,该成形环的横截面包括第一部分和与所述第一部分相连的第二部分,所述第一部分的轮廓线呈弧形且具有第一端点和第二端点,所述第二部分的轮廓线包括与所述第一端点相连且向远离所述第一部分方向延伸的第一段、和自所述第一段远离所述第一端点的端部弯折且朝所述第二端点延伸并与所述第二端部相连的第二段; 所述第一部分的轮廓线的过所述第一端点的切线、所述第一部分轮廓线的过所述第二端点的切线及所述第一段围成一个三角形,且所述三角形中,所述第一部分轮廓线的过所述第一端点的切线与所述第一段之间的夹角为锐角,所述第二段与所述第一部分轮廓线的过所述第二端点的切线重合。 The prosthetic valve according to claim 4, wherein the annuloplasty ring, wherein the ring shaped cross section comprising a first portion and a second portion connected to the first portion, the first portion of the contour line is curved and having a first end and a second end, said second portion comprising a contour line and the first endpoint connected to and extending away from the first portion of the first segment direction, and away from the first segment of the said first end portion bent and extending toward the end of the second segment and a second end portion connected with said second end; a first portion of the contour line of a tangent through the first endpoint, through the second end of the contour tangent of the first segment and the first portion surrounded by a triangle, and the triangle, the first portion through the first end of the contour line and the tangent said acute angle between the first section, the second section coinciding with a tangent of the contour line of the first portion through the second endpoint.
6.根据权利要求1所述的人工瓣膜成形环,其特征在于,所述内核管由金属或高分子材料制成。 6. The prosthetic valve according to claim 1 forming a ring, wherein said core tube is made of a metal or a polymer material.
7.根据权利要求1所述的人工瓣膜成形环,其特征在于,所述柔性材料层为桂胶层。 7. The prosthetic valve according to claim 1 forming a ring, characterized in that the flexible material layer is a subbing layer Gui.
8.根据权利要求1所述的人工瓣膜成形环,其特征在于,所述织物层为涤纶布。 The prosthetic valve according to claim 1, wherein said annuloplasty ring, characterized in that the fabric layer is a polyester fabric.
9.一种如权利要求1-8任一项所述的人工瓣膜成形环的缝合方法,其特征在于,其包括以下步骤: 51、 提供一瓣环半成品,所述瓣环半成品包括非封闭的内核管以及包裹于所述内核管外周的柔性材料层;所述内核管的其中一端部内容置有连接件,所述连接件自所述端部露出; 52、 提供一管材和织物层,所述管材具有尾部以及头部,将所述瓣环半成品的具有所述连接件的端部从所述管材的尾部推入,所述管材的头部从所述织物层的一端进入所述织物层的内部; 53、 移动所述织物层,使所述织物层与所述管材做相对运动,直至所述织物层的一端靠近所述管材的尾部,此时将所述管材全部从所述织物层中抽出,使所述织物层与所述柔性材料层贴合; 54、 将所述织物层远离所述尾部的端部回折,直至将所述连接件露出; 55、 将所述内核管的两端对接并通过 A prosthetic valve according to any of claims 1-8 suture ring shaped, characterized in that it comprises the steps of: 51 providing a semi-finished ring, the annulus comprising a non-closed semifinished and a flexible tube core layer material wrapped on the outer periphery of the core tube; wherein an end portion of the core tube is placed content connecting member, said connecting member is exposed from the end portion; 52, providing a tube and a fabric layer, the said pipe has a head and a tail, said annulus having a semi-finished product end of the connecting member from the end of the pipe pushed into the head portion of the tubing from one end of the fabric layer of the fabric layer interior; 53, moving the fabric layer, the fabric layer and the pipe relative movement, until the end of the fabric layer adjacent to the tail pipe, all this time the tube from the fabric layer extracted, and the fabric layer bonded to the flexible material layer; 54, the fabric layer remote from the tail end portion is folded back until the connecting member is exposed; 55, the two tubes of the core and by the end of the dock 接件固定形成对接处; 56、 将所述织物层回折的所述端部摊平并覆盖住所述内核管的对接处; 57、 将缝合线的一端依次从所述织物层两端部的环状结构中交替穿过,并拉紧所述缝合线。 Fixed abutment is formed at the connection member; 56, the end portion of the fabric layer is folded back smoothing and covers the butt joint of the core tube; 57, a ring sequentially from both end portions of the fabric layer of the suture alternately through the structure, and tightening the suture.
10. 根据权利要求9所述的缝合方法,其特征在于,该缝合方法还包括所述标记线的缝合方法,所述标记线的缝合方法包括以下步骤: 1) 、将连接有缝合线的缝合针的一端从所述织物层扎入,避开所述内核管,并依次穿过所述织物层和柔性材料层; 2) 、所述缝合针的一端自所述织物层穿出后,先调整所述缝合针另一端的角度,再推动所述缝合针自所述缝合针一端穿出的位置扎入,并使其朝所述缝合针另一端所指的方向移动,避开所述内核管并依次穿过所述柔性材料层和织物层,直至所述缝合针全部露出; 3) 、重复步骤1)和步骤2)完成所述标记线的缝合。 10. The method of suturing according to claim 9, wherein the method further comprises suturing the suturing method according to the marking line, the marking line stitching method comprising the steps of: 1), is connected to suture the suture from the end of the needle bar into the fabric layer, to avoid the core tube and passes through the fabric layer and the flexible material layer; 2), one end of said suture needle from piercing the fabric layer after the first the other end of the angle adjustment of the needle, and then pushing the suture needle from the needle end of the bar into the piercing position, and moves in the direction of the other end of the needle within the meaning of, avoiding the core tube and passes through the flexible material layer and a fabric layer, until the whole needle is exposed; 3) repeating steps 1) and 2) the label is completed suture line.
11. 根据权利要求10所述的缝合方法,其特征在于,所述缝合针具有相对的针尖及针尾,所述针尾连接有缝合线且步骤1)中所述针尾从所述织物层扎入。 11. The method of the suture according to claim 10, wherein said suture needle having a tip and an opposite end of the needle, the needle and suture tail connected Step 1) from the end of the needle the fabric layer tie into.
12. 根据权利要求11所述的缝合方法,其特征在于,该人工瓣膜成形环的横截面包括第一部分和与所述第一部分相连的第二部分,所述第一部分的轮廓线呈圆弧形且具有第一端点和第二端点,所述第二部分的轮廓线包括与所述第一端点相连且向远离所述第一部分方向延伸的第一段、和自所述第一段远离所述第一端点的端部弯折且朝所述第二端点延伸并与所述第二端部相连的第二段; 所述第一部分的轮廓线的过所述第一端点的切线、所述第一部分轮廓线的过所述第二端点的切线及所述第一段围成一个三角形,且所述三角形中,所述第一部分轮廓线的过所述第一端点的切线与所述第一段之间的夹角为锐角,所述第二段与所述第一部分轮廓线的过所述第二端点的切线重合。 12. The suture method according to claim 11, characterized in that the cross-section of the artificial annuloplasty ring comprises a first portion and a second portion connected to the first portion, the first portion of the contour circular arc and having a first end and a second end, the second profile section comprises a line connected to said first end and away from the first portion to a first segment extending in a direction, and away from the first section the first endpoint and the bent end portion extending toward said second end of said second section and coupled to the second end portion; a first portion of the contour of the tangent line through the first endpoint , through the second end portion of the first tangent and the first section of contour surrounded by a triangle, and the triangle, the first endpoint through the first portion of the contour line with a tangent the angle between said first section is an acute angle, the second section coinciding with a tangent of the contour line of the first portion through the second endpoint.
13. 根据权利要求10或12所述的缝合方法,其特征在于,该缝合方法还包括所述标记点的缝合方法,其具体包括以下步骤: ① 、所述缝合针从所述第一部分与第二部分相连处扎入,避开所述内核管并完全穿过所述织物层以及所述柔性材料层,围绕所述第一部分的外轮廓回到所述相连处; ② 、所述缝合针从所述相连处扎入并穿过所述织物层和柔性材料层,围绕所述第二部分的外轮廓并回到所述相连处。 13. The suture of claim 10 or claim 12, wherein the suture further comprises the marking method of suturing points, which includes the following steps: ①, the suture needle from the first portion and the second into two parts connected to the tie, and avoiding the core tube completely through the fabric layer and the flexible material layer, back around the outer contour of said first portion connected at; ②, the suture from the needle is connected at the tie into and through the fabric layer and the layer of flexible material around the outer contour of said second portion and is connected at the back.
14.根据权利要求10所述的缝合方法,其特征在于,所述连接件为镍钛套管。 14. The method of claim suture according to claim 10, wherein said connecting member is a nickel-titanium sleeve.
CN201611179799.0A 2016-12-19 2016-12-19 Artificial valvoplasty ring and suturing method thereof CN108201475A (en)

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CN2135346Y (en) * 1992-09-12 1993-06-09 中国人民解放军第四军医大学第一附属医院 Plasticity bicuspid valve shaping ring
US20040210305A1 (en) * 2002-07-16 2004-10-21 Medtronic, Inc. Suture locking assembly and method of use
CN103249376A (en) * 2010-11-30 2013-08-14 爱德华兹生命科学公司 Reduced dehiscence annuloplasty ring
CN104010593A (en) * 2013-07-29 2014-08-27 金仕生物科技(常熟)有限公司 Heart Valve Prosthesis Forming Ring
WO2015095203A1 (en) * 2013-12-16 2015-06-25 The Charlotte-Mecklenburg Hospital Authority D/B/A Carolinas Healthcare System Method and apparatus for therapy of aortic valve
CN105962506A (en) * 2015-03-13 2016-09-28 耐克创新有限合伙公司 Waistband for article of apparel featuring cord and embroidery tunnel
CN106012646A (en) * 2016-07-11 2016-10-12 江苏金呢工程织物股份有限公司 Paper making felt and preparation method thereof

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN2135346Y (en) * 1992-09-12 1993-06-09 中国人民解放军第四军医大学第一附属医院 Plasticity bicuspid valve shaping ring
US20040210305A1 (en) * 2002-07-16 2004-10-21 Medtronic, Inc. Suture locking assembly and method of use
CN103249376A (en) * 2010-11-30 2013-08-14 爱德华兹生命科学公司 Reduced dehiscence annuloplasty ring
CN104010593A (en) * 2013-07-29 2014-08-27 金仕生物科技(常熟)有限公司 Heart Valve Prosthesis Forming Ring
WO2015095203A1 (en) * 2013-12-16 2015-06-25 The Charlotte-Mecklenburg Hospital Authority D/B/A Carolinas Healthcare System Method and apparatus for therapy of aortic valve
CN105962506A (en) * 2015-03-13 2016-09-28 耐克创新有限合伙公司 Waistband for article of apparel featuring cord and embroidery tunnel
CN106012646A (en) * 2016-07-11 2016-10-12 江苏金呢工程织物股份有限公司 Paper making felt and preparation method thereof

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