CN107126299A - High-compliance thoracic aorta covered stent as well as sizing mould and sizing method thereof - Google Patents

High-compliance thoracic aorta covered stent as well as sizing mould and sizing method thereof Download PDF

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CN107126299A
CN107126299A CN 201710426655 CN201710426655A CN107126299A CN 107126299 A CN107126299 A CN 107126299A CN 201710426655 CN201710426655 CN 201710426655 CN 201710426655 A CN201710426655 A CN 201710426655A CN 107126299 A CN107126299 A CN 107126299A
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stent
ring
high
graft
type
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CN 201710426655
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Chinese (zh)
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董永贺
崔跃
马连彩
陈周煜
张宝祥
于学保
李君涛
尚再艳
王兴权
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有研医疗器械(北京)有限公司
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    • 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
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • 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
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • A61F2002/075Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/0056W-shaped, e.g. M-shaped, sigma-shaped
    • 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
    • A61F2240/00Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001Designing or manufacturing processes
    • A61F2240/002Designing or making customized prostheses
    • 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Abstract

The invention relates to a high-compliance thoracic aorta covered stent as well as a sizing mould and a sizing method thereof. The high-compliance thoracic aorta covered stent comprises a coating material and a metallic framework, wherein the coating material attaches to the surface of the metallic framework, so that a tubular structure is formed; the coating material is also fixedly connected with the metallic framework by means of medical sutures; the metallic framework comprises a plurality of W-shaped support rings and screw-type support rings, wherein each screw-type support ring is positioned between every two adjacent W-shaped support rings, and the two ends of each screw-type support ring are respectively and fixedly connected with the every two adjacent W-shaped support rings; one end of the coating material is provided with a W-shaped uncoated stent, and the two ends of the coating material are respectively provided with a development mark. The high-compliance thoracic aorta covered stent is used for interventional therapy of thoracic aortic dissection and thoracic aortic aneurysm, and can improve the compliance of a stent main body; after being implanted into the aorta, the stent can better adapt to the form of the aorta, is better in wall adherence, and can reduce complications such as internal leakage and stent-derived new wound which are caused by stent implantation.

Description

一种高柔顺型胸主动脉覆膜支架及其定型模具和方法 A high-supple thoracic aortic stent graft and a method and casting mold

技术领域 FIELD

[0001] 本发明属于医疗器械技术领域,特别涉及一种微创介入治疗胸主动脉夹层和胸主动脉瘤的高柔顺型胸主动脉覆膜支架及其定型模具和方法。 [0001] The present invention belongs to the technical field of medical devices, particularly to a high-compliant type thoracic aortic stent graft and a method of sizing die and minimally invasive treatment of thoracic aortic dissection and thoracic aortic aneurysms.

背景技术 Background technique

[0002] 主动脉夹层和主动脉瘤是一种高死亡率的血管疾病,且随着人口老龄化加剧及临床诊断技术的不断完善,其发病率/发现率正逐年提高。 [0002] aortic dissection and aortic aneurysm is a high mortality rate of vascular disease, and with the continuous improvement increasing aging population and clinical diagnostic techniques, the incidence rate / positive detection rate increased every year.

[0003] 主动脉夹层和动脉瘤的治疗方法包括内科药物治疗、外科手术治疗和介入治疗。 [0003] The method of treating aneurysms and aortic dissection comprising medical therapy, surgery and interventional therapy. 药物治疗是基础治疗,主要目的是止痛,降低血压和左室射血速率。 Drug therapy is the basic treatment, the main purpose is to relieve pain, lower blood pressure and left ventricular ejection rate. 外科治疗是Stanford A 型病变的主要治疗手段,主要目的是防止主动脉发生破裂或心包填塞;消除主动脉瓣返流和避免心肌缺血。 Surgical therapy is the main treatment for Stanford A type of disease, the main purpose is to prevent aortic rupture or cardiac tamponade occurred; the elimination of aortic regurgitation and avoid myocardial ischemia. 介入治疗又称为腔内治疗(endo vascular aortic repair,EVAR),是上世纪90年代发展起来的一门新技术。 Interventional therapy, also known as endovascular treatment (endo vascular aortic repair, EVAR), is the 1990s developed a new technology. 经过近30年的发展,随着支架的改进及介入技术的不断完善,EVAR技术在主动脉夹层和动脉瘤的应用越来越广泛,并显示出巨大的优越性,取得了满意的近中期疗效,成为治疗主动脉疾病不可或缺的方法。 After nearly 30 years of development, with the continuous improvement and improve interventional stent, EVAR technology becomes more widely in the application of aortic dissection and aneurysm, and showed great superiority, we achieved satisfactory in recent mid-term results It has become an indispensable method for the treatment of aortic disease.

[0004]胸主动脉腔内修复术(Thoracic endovascular aortic repair,TEVRA)就是将与病变段胸主动脉匹配的胸主动脉覆膜支架预置于输送系统内,在X射线透视监视下,经股动脉导入,当支架到达病变胸主动脉部位后,将支架从放送器内释放,并使之恢复至原来口径,使血流从人工血管腔内流过,胸主动脉夹层的内膜破口及瘤样扩张即被隔绝。 [0004] endovascular repair of thoracic aortic (Thoracic endovascular aortic repair, TEVRA) is to match the diseased segment of the thoracic aorta thoracic aortic stent graft delivery system within a preset, under X-ray fluoroscopy monitor, transfemoral introducing artery, when the aortic stent reach the lesion site, the stent is released from the delivery device and allowed to recover to its original diameter, so that blood flowing from the artificial blood vessel lumen, intimal tear and thoracic aortic dissection ectasia ie isolated.

[0005]目前市场上大部分胸主动脉支架的骨架均由“w”型金属支架构成。 [0005] Currently on the market most of thoracic aortic stent skeleton by "w" metal stent configuration. 支架环的结构如此设计优点在于:第一,容易压缩,方便压握使支架放置于体积很小的放送器内;第二,支架整体性佳,释放过程及支架植入主动脉内部后支架不易短缩。 Ring structure of the stent so that the design advantages: first, easily compressed, conveniently crimping the stent placed in the small volume of running; a second, overall good stent, stent implantation after the release process and stent inside the aorta is not easy shortening. 然而,由于该结构的金属支架环在轴向不可弯曲,造成该类型的胸主动脉支架整体较为僵硬,支架植入后不易适应主动脉的迂曲形态,易出现贴壁不良,内漏,鸟嘴征,刺破主动脉形成支架源性新破口等问题。 However, since the metal support ring of the structure is not bent in the axial direction, causing thoracic aortic stent of this type is more rigid whole, it is not easy to adapt to the stent form tortuous aorta, prone to poor adherence, the leakage beak syndrome, endogenous piercing aortic stent break new problems.

发明内容 SUMMARY

[0006]本发明的目的在于提供一种高柔顺型胸主动脉覆膜支架,其用于胸主动脉夹层和胸主动脉瘤的介入治疗,能改善支架主体的柔顺性,支架植入主动脉后更容易适应主动脉形态,贴壁性更佳,能降低由于支架植入所造成的内漏,支架源性新破口等并发症。 [0006] The object of the present invention is to provide a highly supple thoracic aortic stent graft for interventional treatment of thoracic aortic aneurysms and thoracic aortic dissection, can improve flexibility of the stent body, aortic stent after aortic form easier to adapt, better adherent, can be reduced since the leakage caused by the stent, the stent endogenous break new complications.

[0007]本发明的另一目的在于提供一种高柔顺型胸主动脉覆膜支架的定型模具,其结构简单,制造的覆膜支架精确,制造效率高。 [0007] Another object of the present invention is to provide a highly supple thoracic aortic stent-graft sizing die, the structure is simple, accurate stent-graft manufacture, high production efficiency.

[OOOS]本发明的再一目的在于提供一种高柔顺型胸主动脉覆膜支架的定型方法,其过程简单,制造的覆膜支架质量稳定,制造效率高。 A further object of the [OOOS] of the present invention to provide a method for setting a high-compliant type thoracic aortic stent-graft, which process is simple, stable stent graft manufacture quality, high production efficiency.

[0009] 为实现上述目的,本发明采取以下技术方案: [0009] To achieve the above object, the present invention adopts the following technical scheme:

[0010] —种高柔顺型胸主动脉覆膜支架,它包括覆膜材料和金属骨架,该覆膜材料附着于该金属骨架表面,形成筒状结构,并通过医用缝线与该金属骨架固定连接; [0010] - Type High compliant type aortic stent graft, comprising coating material and a metal skeleton, the coating material is adhered to the metal surface of the skeleton, form a cylindrical structure, and by the medical sutures and fixation of the metal skeleton connection;

[0011]该金属骨架包括若干w型支架环和螺旋型支架环,各螺旋型支架环位于相邻的w型支架环之间,且各螺旋型支架环的两端分别与相邻的W型支架环固定连接;该覆膜材料一端设有W型的裸支架,该覆膜材料的两端均设有显影标记。 [0011] The metal frame comprises a plurality of rings w stent rings and spiral stent, the stent between the spiral ring located between adjacent stent rings w, and each of the two ends of the spiral carrier ring with a neighboring W-type carrier ring fixedly connected; the coating material is provided at one end of the W-type bare stent, the graft material at both ends are provided with opaque markers.

[0012] 进一步的,所述覆膜材料外表面设有若千环形的凹槽,所述W型支架环和螺旋型支架环均设置于相邻凹槽之间。 [0012] Further, the outer surface of the coating material is provided with an annular recess if one thousand, the stent W and the helical ring carrier ring are disposed between the adjacent grooves.

[0013] 进一步的,所述凹槽内表面的截面呈弧形,对应圆形的半径为1-5圓,对应的圆心角度为30°_18〇°。 [0013] Further, the section of the inner surface of the arcuate groove, the corresponding radius of the circle is the circle 1-5, corresponding to the central angle of 30 ° _18〇 °.

[0014] 进一步的,相邻凹槽之间的距离为10_20mm,比相应的W型支架环或者螺旋型支架环的高度大2-3mm。 [0014] Further, the distance between adjacent grooves is 10_20mm, the ring than the corresponding W stent or a spiral stent rings large height 2-3mm.

[0015] 进一步的,位于两端的W型支架环的高度低于位于中部的W型支架环的高度。 [0015] Further, at both ends of the stent W ring height lower than the height of the stent W in the middle of the ring.

[0016] 进一步的,位于两端的W型支架环的高度为8mm-12mm,位于中部的W型支架环的高度为13-17mm。 [0016] Further, the height at both ends of the W-shaped carrier ring is 8mm-12mm, the height of the central ring of the stent W is 13-17mm.

[0017] 进一步的,所述螺旋型支架环的丝径小于或者等于所述W型支架环的丝径。 [0017] Further, the wire diameter of the helical stent ring is less than or equal to the wire diameter of the W-shaped carrier ring.

[0018] —种高柔顺型胸主动脉覆膜支架的定型模具,它包括圆柱形的本体,该本体表面间隔设有若千W型区域和螺旋区域,该W型区域包括若干凸起的定型柱,各定型柱的连线形成W型;该螺旋区域为螺旋凹槽,该螺旋凹槽的两端分别与相邻W型区域的定型柱相接。 [0018] - compliant type high casting mold species thoracic aortic stent-graft, comprising a cylindrical body, if the body surface of the spacer is provided with W-type region and one thousand helical regions, the W-type region includes a plurality of convex shape column, column shape is formed in each connection W type; region of the spiral helical grooves, the two ends of the spiral groove are in contact with the shape of the column adjacent to the W-type regions.

[0019] 一种高柔顺型胸主动脉覆膜支架的定型方法,利用所述的定型模具;将丝材绕该定型模具的W型区域和螺旋区域,通过定型柱和螺旋凹槽分别形成W型支架环和螺旋型支架环,通过热处理将各W型支架环和螺旋型支架环定型。 [0019] The method of setting a high-compliant type thoracic aortic stent-graft, using the casting mold; W around the wire helix region type region and the shape of the mold, to form a W shaped by column and each helical groove and a helical stent ring carrier ring, by heat treatment of each ring stent W and the carrier ring spiral shape.

[0020] 进一步的,所述W型区域和螺旋区域的丝材为同一根;或者为不同丝材,通过毛细管材或者弹簧进行连接。 [0020] Further, the wire W-type region and a helix region of the same; or a different wire, connected by a capillary member or a spring.

[0021]本发明的有益效果是:首先,本发明高柔顺型胸主动脉覆膜支架的金属骨架为W型支架环和螺旋型支架环相间排布,具有更佳的柔顺性,可有效降低内漏,支架源性新破口等相关并发症;其次,相对于传统的W型支架环,在相同丝径情况下,螺旋型支架环具有更大的径向支撑力,植入血管后可以达到更好的即时手术效果,使真腔具有更佳的充盈度。 [0021] Advantageous effects of the present invention are: First, high metal frame compliant type according to the present invention is a thoracic aortic stent-graft stent ring W and the carrier ring and white spiral arrangement, having better compliance, can effectively reduce endoleaks, stent related complications derived new break; Secondly, with respect to the conventional type of carrier ring W, in the case of the same wire diameter, spiral type holder ring having a greater radial strength, after the graft vessel can be immediate surgery to achieve better results, the true lumen has better filling degree.

附图说明 BRIEF DESCRIPTION

[0022]图1为本发明高柔顺型胸主动脉覆膜支架一种具体实施方式的示意图。 [0022] FIG. 1 type high compliant aortic stent graft implement a diagram showing a specific embodiment of the present invention.

[0023]图2为本发明高柔顺型胸主动脉覆膜支架的金属骨架的结构示意图。 [0023] FIG. 2 is a schematic structural metal frame compliant type high thoracic aortic stent graft of the present invention.

[0024] 图3为本发明高柔顺型胸主动脉覆膜支架的覆膜材料的结构示意图。 [0024] FIG. 3 is a schematic structural compliant type coating material is higher thoracic aortic stent graft of the present invention.

[0025] 图4为本发明高柔顺型胸主动脉覆膜支架的定型模具的结构示意图。 A schematic view of the casting mold structure [0025] FIG. 4 of the present invention a high compliance of the thoracic aorta stent graft.

[0026] 图5为本发明高柔顺型胸主动脉覆膜支架的金属骨架编织过程示意图。 Metal skeleton weaving process [0026] FIG. 5 of the present invention, a compliant type high thoracic aortic stent-graft FIG.

[0027] 图6为本发明高柔顺型胸主动脉覆膜支架的金属骨架定型过程示意图。 [0027] FIG. 6 is a schematic process of shaping the metal frame compliant type high thoracic aortic stent graft of the present invention.

[0028] 图7为本发明高柔顺型胸主动脉覆膜支架W型支架环的压握示意图。 High compliant swage thoracic aortic stent graft stent W schematic grip ring [0028] FIG. 7 of the present invention.

[0029] 图8为本发明高柔顺型胸主动脉覆膜支架螺旋型支架环的压握示意图。 [0029] Figure 8 is a high compliant swage coil stent graft aortic stent grip ring schematic invention. ^030]图9为本发明高柔顺型胸主动脉覆膜支架螺旋型支架环的另一种实施方式及压握不意图D ^ 030] FIG. 9 is another type of high-supple thoracic aortic stent graft helical crimped stent embodiment and the D ring of the present invention is not intended to

具体实施方式 detailed description

[0031]下面参照附图对本发明的具体实施方式进行详细说明。 [0031] Referring to the drawings embodiments of the present invention will be described in detail.

[0032] 文中胸主动脉覆膜支架靠近心脏的一端为近端,胸主动脉覆膜支架远离心脏的一端为远端。 [0032] paper thoracic aortic stent-graft proximal end near the heart, thoracic aorta stent graft remote from the distal end to the heart.

[0033] 如图1所示,本发明提供一种高柔顺型胸主动脉覆膜支架,可以用于胸主动脉夹层和胸主动脉瘤的介入治疗,它包括覆膜材料1和金属骨架2,该覆膜材料1附着于该金属骨架2表面,形成筒状结构,并通过医用缝线5与该金属骨架2固定连接。 [0033] As shown in FIG 1, the present invention provides a highly supple thoracic aortic stent graft, can be used for treatment of thoracic aortic dissection intervention and thoracic aortic aneurysms, the graft material comprising a metal frame 2 and the coating material is adhered to a second surface of the metal skeleton, form a cylindrical structure, and 52 is fixedly connected to the metal frame by a medical sutures.

[0034] 如图2所示,该金属骨架2包括若干W型支架环21和螺旋型支架环22,各螺旋型支架环22位于相邻的W型支架环21之间,且各螺旋型支架环22的两端分别与相邻的W型支架环21 固定连接,该螺旋型支架环22的丝径小于或者等于该W型支架环21的丝径。 [0034] As shown in FIG. 2, the metal frame 2 comprises a plurality of W-shaped bracket 21 and the helical ring carrier ring 22, each of the spiral holder ring 22 located between adjacent stent W between rings 21, and each helical stent ring ends 22 are adjacent ring stent 21 is fixedly connected to W, the helical wire stent rings 22 is less than or equal to the diameter W stent wire diameter ring 21. 该覆膜材料1可选用医用涤纶材料,为了配合输送系统实现胸主动脉覆膜支架近端的后释放,在其近端设有W型的裸支架23。 The choice of a medical graft material Dacron, with the delivery system to achieve the release of the proximal end of the aortic stent graft, with W-type bare stent 23 at its proximal end. 为了观察和调整胸主动脉覆膜支架在血管内部的位置,在覆膜材料的近端和远端缝有显影标记12,显影标记12由黄金、铂铱合金等重金属制成。 In order to observe and adjust the position of the thoracic aortic stent-graft inside a blood vessel, the proximal and distal ends of the film material sewn opaque markers 12, made of a heavy metal opaque markers 12 of gold, platinum-iridium alloy. 该W型支架环21和螺旋型支架环22均用医用缝线缝合于覆膜材料1内部,缝线主要用于固定W型支架环21,螺旋型支架环22可不用缝线进行固定,或在圆周方向有1-2个点用缝线进行固定。 The W-type stent rings 21 and 22 are helical carrier ring with a medical suture to the internal graft material 1, is mainly used for fixing the suture ring W-bracket 21, a helical bracket 22 can be fixed without a suture ring, or 1-2 points fixed with sutures in the circumferential direction.

[0035] 位于两端的W型支架环的高度低于位于中部的W型支架环的高度。 [0035] The height at both ends of the stent W W ring is lower than the height of the stent in the middle of the ring. 例如,位于两端的W型支架环的高度为8mm-12mm,位于中部的W型支架环的高度为13-17mm。 For example, the height at both ends of the W-shaped carrier ring is 8mm-12mm, the height of the central ring of the stent W is 13-17mm. 以此设置,可以使支架近端和远端具有更佳的柔顺性和更大的径向支撑力,并且降低支架中部在释放过程和植入血管以后发生短缩的风险。 With this arrangement, the proximal and distal stent can have better flexibility and greater radial strength, and reduce the risk of shortening the center stand occurred during and after the release of the graft vessel.

[0036] 如图3所示,该覆膜材料1外表面设有若干环形的凹槽11,该W型支架环21和螺旋型支架环22均设置于相邻凹槽11之间。 [0036] As shown in FIG. 3, an outer surface of the coating material is provided with a plurality of annular grooves 11, the W-shaped bracket 21 and the helical ring carrier ring 22 are disposed between the adjacent recesses 11. 该凹槽11内表面的截面呈弧形,对应圆形的半径为1-5mm,对应的圆心角度为30°-180°。 Section of the inner surface 11 of the arcuate recess corresponding to 1-5mm radius of the circle, corresponding to the center angle of 30 ° -180 °. 相邻凹槽11之间的距离为l〇_2〇mm,比相应的W型支架环21或者螺旋型支架环22的高度大2-3mm,凹槽11位置无支架环。 The distance between the grooves 11 adjacent to l〇_2〇mm large height 2-3mm 21 or a spiral stent ring 22 of the ring than the corresponding stent W, the position of the groove-free carrier ring 11.

[0037] 如图4所示,本发明还提供一种高柔顺型胸主动脉覆膜支架的定型模具,它包括圆柱形的本体3,该本体3表面间隔设有若干W型区域和螺旋区域,该W型区域包括若干凸起的定型柱31,各定型柱31的连线形成W型。 [0037] 4, the casting mold of the present invention also provides a highly supple thoracic aortic stent-graft, comprising a cylindrical body 3, the body surface of the spacer 3 defines a plurality of W-type region and a spiral region the W-type region comprises a plurality of projections 31 shaped column, the column lines of the shape 31 formed W type. 该螺旋区域为螺旋凹槽32,该螺旋凹槽32的两端分别与相邻W型区域的定型柱31相接。 The helical spiral groove region 32, the two ends of the spiral groove 32 are in contact with the amorphous region of the column 31 adjacent to the W-type.

[0038] 如图5-图6所示,本发明还提供一种高柔顺型胸主动脉覆膜支架的定型方法,利用上述图4中的定型模具3。 [0038] As shown in FIG. 5 to FIG. 6, the present invention also provides a method for setting a high-compliant type thoracic aortic stent-graft, using the casting mold 3 in FIG. 4 described above. 将丝材4,例如NiTi形状记忆合金丝材,绕该定型模具3的W型区域和螺旋区域,通过定型柱31和螺旋凹槽32分别形成W型支架环21和螺旋型支架环22,通过热处理将各W型支架环21和螺旋型支架环22定型。 The wire 4, e.g. NiTi shape memory alloy wire, about the casting mold W-type region and the helical region 3, the carrier ring 21 and a W-type helical stent ring 2231 and the helical grooves 32 are formed by setting the column, by each heat carrier ring 21 and a W-shaped carrier ring 22 a helical shape.

[0039] 该W型区域和螺旋区域的丝材可以为同一根;或者为不同丝材,通过毛细管材或者弹簧进行连接。 [0039] The wire W helix region type region and may be the same one; or a different wire, connected by a capillary member or a spring.

[0040] 当W型支架环21和螺旋型支架环22由一根丝材编织而成,该螺旋型支架环22的丝径等于该W型支架环21的丝径,螺旋型支架环22的径向支撑力大于W型支架环21的径向支撑力。 [0040] When the carrier ring 21 and a W-shaped helical loop 22 by weaving a stent wire is made, the helical wire 22 of the carrier ring diameter equal to the diameter of the wire W stent ring 21, the helical stent ring 22 W is greater than the radial strength stent radial force ring 21. 当W型支架环21和螺旋型支架环22分别由不同丝材编织而成,且W型支架环W的丝径大于螺旋型支架环22的丝径,以此设置,两种结构的支架环径向支撑力较为接近,支架环分别定型后用毛细管材或者弹簧进行连接。 When the carrier ring 21 and a W-shaped carrier ring 22 are spiral woven wire made of different, and W stent wire diameter is larger than the spiral ring W stent wire diameter ring 22, this arrangement, two structures holder ring radial force closer, connected with a capillary member or a spring rear mount ring shape, respectively. _ _

[0041] 如图7-图9所示,本发明的W型支架环21和螺旋型支架环22均可进行径向压缩,压缩后可装入内径很小的输送系统,以便于通过微创介入治疗的方式将直径较大的胸主动脉覆膜支架输送至主动脉弓部。 [0041] As shown in FIG. 7 to 9, W-type carrier ring and the coil 21 of the present invention stent can be radially compressed ring 22, the inner diameter of the compression can be loaded into a delivery system is small, so that minimally invasive intervention manner large diameter thoracic aortic stent graft delivered to the aortic arch. LUU42」_图8为本发明胸主动脉覆膜支架一种标准的螺旋型支架环22的压握示意图,该支架环为标准的螺旋型,起始端和尾端在圆周方向相差90。 Spiral stent Thoracic aortic stent graft LUU42 a standard "of the present invention. FIG. 8 _ crimped ring 22 is a schematic view of the carrier ring is a standard screw-type, the starting end and the trailing end 90 differ in the circumferential direction. .

[0043]图9为本发明胸主动脉覆膜支架螺旋型支架环22的另一种实施方式及其压握示意图,该支架环在标准螺旋型支架环的基础上,每间隔90°有轻微起伏,以此设置可更加方便支架环的压缩,减小支架环压缩后的应力。 [0043] FIG. 9 thoracic aortic stent-graft and the helical stent crimping ring schematic way a further embodiment 22 of the present invention, the carrier ring on the standard carrier ring on the spiral, there is a slight 90 ° intervals undulating, this arrangement makes it easier compression ring of the stent, reducing the compressive stress after the stent ring.

[0044]需要说明的是,以上所述仅是本发明较佳的具体实施方式而已,目的是为了使本领域技术人员更好的理解本发明,不应用以限制本发明的范围及应用,凡是在本发明的精神或原则之内,所做的任何修改、等同替换、改进等均应包含在本发明所保护的范围之内。 [0044] Incidentally, the above are merely preferred embodiments of the present invention DETAILED DESCRIPTION only purpose is to enable those skilled in the art a better understanding of the present invention, not be used to limit the scope and application of the present invention, all or within the spirit of the principles of the present invention, any changes made, equivalent substitutions, improvements, etc. should be included within the scope of the claimed invention.

Claims (10)

  1. 1. 一种高柔顺型胸主动脉覆膜支架,其特征在于,它包括覆膜材料和金属骨架,该覆膜材料附着于该金属骨架表面,形成筒状结构,并通过医用缝线与该金属骨架固定连接; 该金属骨架包括若干W型支架环和螺旋型支架环,各螺旋型支架环位于相邻的'^型支架环之间,且各螺旋型支架环的两端分别与相邻的ff型支架环固定连接;该覆膜材料一端设有W型的裸支架,该覆膜材料的两端均设有显影标记。 1. A high-supple thoracic aortic stent graft, characterized in that it comprises a coating material and a metal skeleton, the coating material is adhered to the metal surface of the skeleton, form a cylindrical structure, and by the medical suture fixedly connected to the metal frame; the backbone comprises a plurality of metal rings W stent rings and spiral stent, the stent between the spiral ring is located adjacent '^ stent ring, and each ring is a spiral stent, respectively, and the adjacent ends ff type of carrier ring fixedly connected; the coating material is provided at one end of the W-type bare stent, the graft material at both ends are provided with opaque markers.
  2. 2. 根据权利要求1所述的高柔顺型胸主动脉覆膜支架,其特征在于,所述覆膜材料外表面设有若干环形的凹槽,所述W型支架环和螺旋型支架环均设置于相邻凹槽之间。 The high-supple thoracic aortic stent-graft of claim 1, wherein said coating material is an outer surface provided with a plurality of annular grooves, the stent W and the helical ring carrier ring are is provided between adjacent grooves.
  3. 3. 根据权利要求2所述的高柔顺型胸主动脉覆膜支架,其特征在于,所述凹槽内表面的截面呈弧形,对应圆形的半径为1 -5mm,对应的圆心角度为30 ° -180 °。 The high-supple thoracic aortic stent-graft of claim 2, wherein the recess section of the curved surface, corresponding to the radius of the circle is 1 -5mm, central angle corresponding to 30 ° -180 °.
  4. 4. 根据权利要求2或3所述的高柔顺型胸主动脉覆膜支架,其特征在于,相邻凹槽之间的距离为10-20mm,比相应的W型支架环或者螺旋型支架环的高度大2-3mm。 The thoracic aorta highly compliant stent graft of claim 2 or claim 3, characterized in that the distance between adjacent grooves is 10-20mm, the ring than the corresponding W stent or a spiral stent ring the height of the big 2-3mm.
  5. 5. 根据权利要求1所述的高柔顺型胸主动脉覆膜支架,其特征在于,位于两端的W型支架环的高度低于位于中部的W型支架环的高度。 The high compliance of the thoracic aorta stent graft as claimed in claim 1, characterized in that the height W of the ring-shaped bracket lower than the height at both ends of the stent W in the middle of the ring.
  6. 6. 根据权利要求5所述的高柔顺型胸主动脉覆膜支架,其特征在于,位于两端的W型支架环的高度为8mm-12mm,位于中部的W型支架环的高度为13-17mm。 The high thoracic aortic stent graft compliant type according to claim 5, characterized in that the height at both ends of the stent W ring is 8mm-12mm, the height of the central ring of the stent W is 13-17mm .
  7. 7. 根据权利要求1所述的高柔顺型胸主动脉覆膜支架,其特征在于;所述螺旋型支架环的丝径小于或者等于所述W型支架环的丝径。 The high compliance of the thoracic aorta stent graft as claimed in claim 1, characterized in that; said helical wire stent ring diameter is less than or equal to the wire diameter of the W-shaped carrier ring.
  8. 8. —种高柔顺型胸主动脉覆膜支架的定型模具,其特征在于,它包括圆柱形的本体,该本体表面间隔设有若干W型区域和螺旋区域,该W型区域包括若干凸起的定型柱,各定型柱的连线形成W型;该螺旋区域为螺旋凹槽,该螺旋凹槽的两端分别与相邻W型区域的定型柱相接。 8. - casting mold kinds of high-compliant type thoracic aortic stent-graft, characterized in that it comprises a cylindrical body, the body surface provided with a plurality of spaced helical regions and the W-type region, the region comprising a plurality of projection type W setting the column lines of the column to form a W-type shape; region of the spiral helical grooves, the two ends of the spiral groove are in contact with the shape of the column adjacent to the W-type regions.
  9. 9. 一种高柔顺型胸主动脉覆膜支架的定型方法,其特征在于,利用权利要求8所述的定型模具;将丝材绕该定型模具的W型区域和螺旋区域,通过定型柱和螺旋凹槽分别形成W型支架环和螺旋型支架环,通过热处理将各W型支架环和螺旋型支架环定型。 A method of shaping a compliant type high thoracic aortic stent-graft, characterized in that the casting mold according to claim 8, using; W around the wire helix region type region and the shape of the mold, and by setting the column W are formed helical groove and helical stent ring carrier ring, by heat treatment of each ring stent W and the carrier ring spiral shape.
  10. 10. 根据权利要求9所述的高柔顺型胸主动脉覆膜支架的定型方法,其特征在于,所述W 型区域和螺旋区域的丝材为同一根;或者为不同丝材,通过毛细管材或者弹簧进行连接。 10. The method of setting the compliant type high thoracic aortic stent-graft according to claim 9, characterized in that the wire W-type region and a helix region of the same; or a different wire by capillary material or the spring connection.
CN 201710426655 2017-06-08 2017-06-08 High-compliance thoracic aorta covered stent as well as sizing mould and sizing method thereof CN107126299A (en)

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