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Publication numberCN103071230 A
Publication typeApplication
Application numberCN 201310030803
Publication date1 May 2013
Filing date28 Jan 2013
Priority date28 Jan 2013
Also published asCN103071230B
Publication number201310030803.7, CN 103071230 A, CN 103071230A, CN 201310030803, CN-A-103071230, CN103071230 A, CN103071230A, CN201310030803, CN201310030803.7
Inventors成正辉, 张安
Applicant湖南埃普特医疗器械有限公司
Export CitationBiBTeX, EndNote, RefMan
External Links: SIPO, Espacenet
Controllable bent guiding catheter and manufacture method thereof
CN 103071230 A
Abstract
The invention discloses a controllable bent guiding catheter and a manufacture method thereof, solving the technical problems of shortening operation time and increasing operation safety. The controllable bent guiding catheter is provided with a catheter, wherein a handle is connected to the near end of the catheter, the remote end of the catheter is provided with a catheter bending section, the catheter bending section is connected with the remote end of a metal pull wire, the near end of the metal pull wire is connected to the handle, and the handle is bent through controlling the catheter bending section by the metal pull wire. The manufacture method disclosed by the invention comprises the steps of: manufacturing an axial support combination member, manufacturing the catheter and assembling. Compared with the prior art, the controllable bent guiding catheter has the advantages that the relative positions of an external handle and a pull rod as well as the external handle and a push rod are regulated, the remote end of the catheter bending section is bent and deformed, the relative displacement of the external handle and the push rod is controlled, and the remote end of the catheter is bent controllably, so that one catheter can enter the left coronary artery and the right coronary artery, the operation time is shortened, and the safety of the coronary artery intervention operation is improved. The controllable bent guiding catheter is also suitable for hearts of different sizes and coronary arteries with different openings.
Claims(10)  translated from Chinese
1.一种可控弯导引导管,设有导管,导管的近端连接有手柄,其特征在于:所述导管的远端为导管弯曲段(7),导管弯曲段(7)连接金属拉线(8)的远端,金属拉线(8)的近端连接在手柄上,手柄经金属拉线(8 )控制导管弯曲段(7 )弯曲。 A controllable curved guide catheter, provided with a conduit connected to the proximal end of the handle, characterized in that: the distal end of the catheter is a curved conduit section (7), a curved conduit section (7) connected to a metal wire (8) the distal end of the metal cable (8) connected to the proximal end of the handle, the handle via a metal wire (8) control conduit bending segment (7) is bent.
2.根据权利要求1所述的可控弯导引导管,其特征在于:所述导管弯曲段(7)的远端端部套置有显影示标(9),显影示标(9)的近端套置有金属环锚点(10),金属环锚点(10)与显影示标(9)之间的距离为4mm〜30mm,所述金属拉线(8)远端与金属环锚点(10)焊接连接。 Controllable according to claim 1, wherein the curved guide catheter, characterized in that: said curved conduit section (7) of the distal end portion of the sleeve is set with a developing shows marked (9), showing a developing standard (9) a metal ring sleeved proximal anchor (10), the metal ring from the anchor (10) and the developing shows standard (9) between the 4mm~30mm, the metal wire (8) and the metal ring distal anchor (10) welded connections.
3.根据权利要求2所述的可控弯导引导管,其特征在于:所述导管弯曲段(7)在自由状态为直线状,被弯曲的角度为:0 <角度< 270 ;或所述导管弯曲段(7)在自由状态为弯曲状,弯曲的角度为:0 <角度彡90,被弯曲的角度为:0 <角度彡270,被弯曲的方向与导管弯曲段(7)在自由状态弯曲的方向相反。 Controllable according to claim 2, wherein the curved guide catheter, characterized in that: said curved conduit section (7) in the free state is straight, bent angle: 0 <angle <270 ; or the said curved conduit section (7) in the free state in a curved shape, the bending angle is: 0 <angle San 90 , the bent angle is: 0 <angle San 270 , the direction of the catheter is bent curved section (7) On the contrary in the free state is bent in the direction.
4.根据权利要求3所述的可控弯导引导管,其特征在于:所述导管弯曲段(7)在显影示标(9)与金属环锚点(10)之间的部分,在自由状态为弯曲状;或所述导管弯曲段7和导管非弯曲段6的连接处,在自由状态为弯曲状。 4. The controllable bending of the guide catheter according to claim 3, wherein: said curved conduit section (7) between the developing shows standard (9) and the metal ring anchor (10) portions, the free state into a curved shape; or curved section of the catheter 7 and the catheter 6 at the non-curved sections of the connection, in the free state into a curved shape.
5.根据权利要求1所述的可控弯导引导管,其特征在于:所述导管由远端的导管弯曲段(7)和导管非弯曲段(6)连接构成。 According to any one of the controllable curved guide catheter as claimed in claim wherein: said catheter from the distal end of the catheter the curved section (7) and a non-curved conduit section (6) connected to form.
6.根据权利要求5所述的可控弯导引导管,其特征在于:所述导管弯曲段(7)和导管非弯曲段(6)设有导管内层(11)、导管中间层(12)和导管外层(13),导管外层(13)套置在导管内层(11)外,导管中间层(12)嵌入在导管外层(13)内;所述导管内层(11)采用聚四氟乙烯,导管中间层(12)为金属丝编织网,导管外层(13)采用硬度为25D〜72D的高分子聚合物材料嵌段聚酰胺、尼龙或聚氨酯,导管弯曲段(7)采用相对柔软的高分子聚合物材料,导管非弯曲段(6)采用硬度相对较高的高分子聚合物材料;所述金属环锚点(10)嵌入在导管外层(13)内。 5 according to the guiding catheter curved controllable claim, wherein: said curved conduit section (7) and a non-curved conduit section (6) is provided with an inner duct (11), the conduit of the intermediate layer (12 ) and an outer conduit (13), the outer conduit (13) disposed in the conduit sleeve inner layer (11), the conduit of the intermediate layer (12) embedded in the outer conduit (13); said inner conduit (11) PTFE, catheter intermediate layer (12) is a metal wire braid, the outer conduit (13) using a hardness of polymer material block amide, nylon or polyurethane, curved section 25D~72D catheter (7 ) with a relatively soft polymer material, non-curved conduit section (6) the use of relatively high hardness polymer material; anchor said metal ring (10) embedded in the outer conduit (13).
7.根据权利要求6所述的可控弯导引导管,其特征在于:所述金属环锚点(10)的近端一侧,沿导管的轴向方向,在导管外层(13)内形成有截面为孔状的拉线腔(15);在导管非弯曲段(6),拉线腔(15)内设有轴向支撑组合件(14),金属拉线(8)设置在导管弯曲段(7)的拉线腔(15)和导管非弯曲段(6)的轴向支撑组合件(14)孔内:所述轴向支撑组合件(14)设有内层(17)、中间层(18)和外层(19),所述内层(17)采用聚四氟乙烯,中间层(18)为金属丝编织的网或绕制的螺旋弹簧状,外层(19)为高分子聚合物聚酰亚胺、聚醚醚酮、尼龙、嵌段聚酰胺或聚氨酯。 7. The controllable bending of the guide catheter according to claim 6, wherein: the metal ring anchor (10) of the proximal end side, in the axial direction of the catheter, the outer catheter (13) There is formed a hole shape of the wire cross section cavity (15); non-curved section of the catheter (6), the cable cavity (15) is provided with a curved section of the catheter axially support assembly (14), a metal cable (8) Set ( 7) of the cable cavity (15) and a non-curved conduit section (6) of the axial support assembly (14) hole: the axial support assembly (14) is provided with an inner layer (17), the intermediate layer (18 ) and an outer layer (19), said inner layer (17) with PTFE, an intermediate layer (18) of woven wire mesh or wound like a coil spring, the outer layer (19) of polymer polyimide, polyetheretherketone, nylon, polyamide or polyurethane blocks.
8.根据权利要求1所述的可控弯导引导管,其特征在于:所述手柄设有筒状的推杆(4)和外手柄(3),推杆(4)的近端伸进外手柄(3)沿轴向的通孔远端的一段内,形成有阻尼滑动连接;所述外手柄(3 )通孔近端的一段内设有拉线固定装置(25 ),所述金属拉线(8 )的近端连接在拉线固定装置(25)上。 According to one of the curved guide catheter controllable claim, characterized in that: said handle has a cylindrical rod (4) and an outer handle (3), the push rod (4) extending into the proximal end of the outer handle (3) along the inner section of the distal end of an axial through hole formed damping slidably connected; said outer handle (3) a section of the proximal end of the through-holes equipped with cable securing means (25), said metal wire (8) connected to the proximal end of the cable fixing means (25).
9.根据权利要求8所述的可控弯导引导管,其特征在于:所述推杆(4)的外圆周上开有限位槽(21),限位槽(21)的长度方向平行于推杆(4)的轴线方向;所述外手柄(3)上沿径向开有销孔,销孔内插入有限位销(23),限位销(23)向内伸出销孔的一段插入限位槽(21)内。 9. 8, wherein the guide catheter bend controllable claim, wherein: said push rod opening of a finite bit groove (4) of the outer circumference (21), the stopper grooves (21) parallel to the longitudinal direction push rod (4) in the axial direction; along the exterior lever (3) the radial pin hole is opened, the pin insertion hole of a finite bit pin (23), the stopper pin (23) inwardly projecting section of the pin hole insert the stopper groove (21).
10.一种可控弯导引导管的制备方法,包括以下步骤:一、制作轴向支撑组合件, 内层米用聚四氟乙烯,内径为0.25mm〜2.5mm,厚0.02mm〜0.1mm,长度为40cm〜.130cm ; 中间层采用丝径为0.0lmm〜0.1mm的不锈钢丝、钨丝、钴铬合金丝、钛合金丝或镍钛合金丝,丝数为8〜32根,编织成30〜200PPI的网,或转速为5〜20r/min,绕制成外径为.0.3mm〜3.0mm,螺距为0.02mm〜0.2mm的螺旋弹簧状; 外层采用高分子聚合物聚酰亚胺、聚醚醚酮、尼龙、嵌段聚酰胺或聚氨酯,外径为.0.4mm 〜3.1mm ; 将内层、中间层、夕卜层按层次套置在外径为0.25mm〜2.5mm,长度为40cm〜130cm的金属或塑料芯棒上,在外面套上内径为l.(T3.0mm,收缩比为1.3:f 2:1的氟化乙烯丙烯共聚物热收缩管,流变温度38(T450 F,流变速度0.08、.25cm/s,自然冷却至室温后,剥掉热收缩管,拔出芯棒完成轴向支撑组合件的制作; 二、制作导管, 导管内层米用聚四氟乙烯管,内径为0.6mm〜6.0mm,厚0.02mm〜0.1mm,长600_〜.1450mm ; 导管中间层采用8〜32根丝径为0 .02mm〜0.1mm不锈钢丝或镍钛合金丝,编织成.30PPI〜100PPI的金属网; 导管外层采用硬度为2〜72D的高分子聚合物材料嵌段聚酰胺、尼龙或聚氨酯管,夕卜径为Imm〜7mm,导管弯曲段采用相对柔软的高分子聚合物管,长IOmm〜IOOmm ;导管非弯曲段采用硬度相对较高的高分子聚合物管,长600mm〜1400mm ; 显影标记采用钼铱合金、钼、金、钽、钨、含钨的高分子材料或含Bi2O3的高分子材料环,尺寸为0.6謹〜6.0mm ; 金属环锚点采用不锈钢、镍钛合金或钼铱合金环,尺寸为0.6mm〜6.0mm ; 金属拉线米用丝径为0.1mm〜0.5mm的不锈钢丝或镍钛合金丝,长700mm〜1600mm ;将金属拉线的一端焊接在金属环锚点,焊接电流为75A〜200A,脉宽为2ms〜10ms,金属拉线的另一端穿过轴向支撑组合件; (1)将导管内层套置在外径为0.6mm〜6.0mm,长度为600mm〜1450mm,沿轴线带有凹槽的金属芯棒上;(2)按顺序从远端,将显影标记、带金属拉线的金属环锚点套置在导管内层位于导管弯曲段的位置,显影标记和金属环锚点之间的距离为4mm〜30mm ; (3)将轴向支撑组合件沿轴向设置在导管内层的导管非弯曲段的金属芯棒的凹槽位置;(4)将导管中间层套置在金属环锚点和轴向支撑组合件之外;(5)在导管中间层外套置导管外层,长IOmm〜IOOmm的导管外层套置在远端;(6)在导管外层外套上内径为1.3^9.5mm,收缩比为.1.3^2:1的氟化乙烯丙烯共聚物热收缩管,流变温度38(T450 F,流变速度0.08、.25cm/s,自然冷却至室温后,剥掉热收缩管,拔出芯棒,得到导管; 三、推杆、外手柄、限位销、拉线固定装置采用医用不锈钢材料,按现有机械加工方法制作; 四、组装,得到可控弯导引导管。 10. A method for preparing a controlled curved guiding catheter, comprising the following steps: First, the production axial support assembly, the inner layer m polytetrafluoroethylene, an inner diameter of 0.25mm~2.5mm, thick 0.02mm~0.1mm length of 40cm~.130cm; middle layer 0.0lmm~0.1mm wire diameter stainless steel wire, tungsten wire, cobalt-chromium alloy wire, titanium wire or nitinol wire, wire number 8~32 roots, woven into 30~200PPI net, or speed of 5~20r / min, about having an outer diameter of .0.3mm~3.0mm, pitch helical spring-like 0.02mm~0.2mm; the outer layer of polyimide polymers amine, polyetheretherketone, nylon, polyamide or polyurethane blocks, an outer diameter of .0.4mm ~3.1mm; inner layer, an intermediate layer, Xi Bu layer hierarchically arranged in sets of an outer diameter of 0.25mm~2.5mm, length of metal or plastic mandrel 40cm~130cm, and put out an inner diameter of l (T3.0mm, shrinkage ratio of 1.3:. f 2: fluorinated ethylene propylene copolymer heat-shrinkable tube 1, flow temperature 38 ( T450 F, flow rate 0.08, .25cm / s, naturally cooled to room temperature, stripped of heat shrinkable tube, pull mandrel assembly complete axial support production; two, making a conduit inner yards with poly tetrafluoroethylene tube inner diameter 0.6mm~6.0mm, thick 0.02mm~0.1mm, long 600_~.1450mm; catheter middle layer 8~32 0 .02mm~0.1mm filament diameter stainless steel wire or nitinol wire , .30PPI~100PPI woven metal mesh; duct outer layer of polymer material hardness 2~72D block polyamide, nylon or polyurethane tube, Xi Bu diameter Imm~7mm, conduit bending section with relative flexible polymer tube, long IOmm~IOOmm; catheter unbent section with a relatively high hardness polymer tube, long 600mm~1400mm; developing markers molybdenum iridium alloy, molybdenum, gold, tantalum, tungsten, including tungsten-containing polymer materials or polymer materials Bi2O3 ring size 0.6 would like ~6.0mm; metal ring anchor made of stainless steel, nickel, titanium or molybdenum iridium alloy ring, size 0.6mm~6.0mm; m with a metal cable wire diameter stainless steel wire or nitinol wire 0.1mm~0.5mm and long 700mm~1600mm; the end of the weld metal in the metal ring anchor cable, welding current 75A~200A, pulse width 2ms~10ms, metal wire the other end through the axial support assembly; (1) an inner sleeve disposed in the catheter outside diameter 0.6mm~6.0mm, length 600mm~1450mm, with the axial grooves on the metal core rod; (2) metal ring anchor sleeve is set in the order from the distal end, the developing marker, with a metal wire located at the position of the catheter in the catheter inner curved section, from developing between the anchor tag and the metal ring is 4mm~30mm; (3) The axial support assembly axially disposed in the groove position of the metal inner mandrel catheter catheter of non-curved section; (4) the sleeve catheter disposed in the intermediate layer outside the metal ring axially anchor and support assembly ; (5) the jacket conduit is set in the outer conduit of the intermediate layer, length IOmm~IOOmm catheter outer sheath disposed in a distal end; (6) in the outer jacket on the conduit inner diameter 1.3 ^ 9.5mm, contraction ratio .1.3 ^ 2: 1 copolymer of fluorinated ethylene propylene heat shrinkable tube, flow temperature 38 (T450 F, flow rate 0.08, .25cm / s, naturally cooled to room temperature, stripped of heat shrinkable tube, pull mandrel, get the catheter; three, putting, outside handle, limit sales, cable fixtures using medical stainless steel, according to the existing method of machining production; four, assembly, obtain a controlled bending of the guiding catheter.
Description  translated from Chinese

可控弯导引导管及其制备方法 Controlled bend guiding catheter and its preparation method

技术领域 FIELD

[0001] 本发明涉及一种医疗器械及其制备方法,特别是一种介入治疗的导引导管及其制备方法。 [0001] The present invention relates to a medical device and its preparation method, especially a method of treating and a preparation method of the guiding catheter intervention.

[0002] 背景资料 [0002] Background Information

[0003] 导引导管是经皮冠状动脉介入治疗手术必不可少的辅助导管,通过将导引导管送入冠状动脉入口,为导丝、球囊或支架提供进入通道。 [0003] The catheter is guided percutaneous coronary intervention surgery indispensable auxiliary catheter through the guide catheter into the coronary entrance, providing access to the channel for the guidewire, balloon or stent. 由于患者的心脏大小和冠状动脉开口的形状不完全相同,为了适应患者的不同冠脉动脉,导引导管的远端做成多种弯形。 Due to the size and shape of the patient's heart coronary artery is not exactly the same, in order to adapt to the different coronary arteries in patients with distal end of the guiding catheter made of a variety of curved shape. 现有技术的导引导管为固定弯形,其弯型复杂,类型繁多,这样为医生选择导引导管带来了不便,同时医生在手术过程中需要更换多种不同弯形的导引导管,这样不仅延长了手术的时间,加大了患者的痛苦,还增加了手术的风险。 The prior art curved guide catheter is fixed, its curved complex and many different types, so that the doctor selected as the guide catheter inconvenience, while the doctor during surgery needs to be replaced a number of different curved guiding catheter, This will not only prolong the operation time, increasing the suffering of patients, but also increases the risk of surgery.

发明内容 SUMMARY

[0004] 本发明的目的是提供一种可控弯导引导管及其制备方法,要解决的技术问题是缩短手术时间,提高手术安全性。 [0004] The present invention is to provide a controlled bending of the guide catheter and a preparation method, technical problems to be solved is to shorten the operation time, improve surgical safety.

[0005] 本发明采用以下技术方案:一种可控弯导引导管,设有导管,导管的近端连接有手柄,所述导管的远端为导管弯曲段,导管弯曲段连接金属拉线的远端,金属拉线的近端连接在手柄上,手柄经金属拉线控制导管弯曲段弯曲。 [0005] The present invention employs the following technical scheme: a controlled curved guide catheter, provided with a conduit connected to the proximal end of the handle, the distal end of the catheter to the catheter the curved section, the curved sections connecting the metal wire catheter distal end, the proximal end of the metal wire is connected to the handle, the handle control conduit via a metal wire bent section is bent.

[0006] 本发明的导管弯曲段的远端端部套置有显影示标,显影示标的近端套置有金属环锚点,金属环锚点与显影示标之间的距离为4mm〜30mm,所述金属拉线远端与金属环锚点焊接连接。 [0006] The distal end of the catheter is sleeved curved section of the present invention have shown marked development, the subject of the proximal end of the developing sleeve is set there is shown a metal ring anchor, the anchor and the developing from the metal ring between the standard shown 4mm~30mm The metal wire connected to the distal anchor weld metal ring.

[0007] 本发明的导管弯曲段在自由状态为直线状,被弯曲的角度为:0 <角度≤ 270 ;或所述导管弯曲段在自由状态为弯曲状,弯曲的角度为:0 <角度≤ 90,被弯曲的角度为:0 <角度< 270,被弯曲的方向与导管弯曲段在自由状态弯曲的方向相反。 [0007] The present invention is a catheter curved section in the free state is straight, the bent angle is: 0 <angle ≤ 270 ; or the curved section of the catheter into a curved shape in the free state, the bending angle is: 0 <angle ≤ 90 , the bent angle is: 0 <angle <270 , the catheter is bent in a direction opposite to the curved section is bent in the direction of a free state.

[0008] 本发明的导管弯曲段在显影示标与金属环锚点之间的部分,在自由状态为弯曲状;或所述导管弯曲段7和导管非弯曲段6的连接处,在自由状态为弯曲状。 [0008] between the developing and the metal ring shown subscript anchor portion of the catheter of the present invention, the curved segment, in the free state in a curved shape; or curved section of the conduit 7 and a non-curved segments are connected at the duct 6, in the free state a curved shape.

[0009] 本发明的导管由远端的导管弯曲段和导管非弯曲段连接构成。 [0009] The catheter of the present invention is composed of the distal end of the catheter and catheter curved section non-curved segments connected to form.

[0010] 本发明的导管弯曲段和导管非弯曲段设有导管内层、导管中间层和导管外层,导管外层套置在导管内层外,导管中间层嵌入在导管外层内;所述导管内层采用聚四氟乙烯,导管中间层为金属丝编织网,导管外层采用硬度为25D〜72D的高分子聚合物材料嵌段聚酰胺、尼龙或聚氨酯,导管弯曲段采用相对柔软的高分子聚合物材料,导管非弯曲段采用硬度相对较高的高分子聚合物材料;所述金属环锚点嵌入在导管外层内。 [0010] curved section and the catheter tube of the present invention has a non-curved section inner conduit, the conduit of the intermediate layer and the outer layer of the catheter, the catheter outer sheath disposed in the inner conduit, the conduit of the intermediate layer is embedded within the outer conduit; the said inner layer of Teflon catheter, the catheter intermediate layer is a metal wire braid, the outer layer of the catheter a hardness of polymer material block amide, nylon or polyurethane, using a catheter the curved section of a relatively soft 25D~72D polymer material, non-curved conduit section with relatively high hardness polymer material; anchor the metal ring is embedded within the catheter outer layer.

[0011] 本发明的金属环锚点的近端一侧,沿导管的轴向方向,在导管外层内形成有截面为孔状的拉线腔;在导管非弯曲段,拉线腔内设有轴向支撑组合件,金属拉线设置在导管弯曲段的拉线腔和导管非弯曲段的轴向支撑组合件孔内:所述轴向支撑组合件设有内层、中间层和外层,所述内层采用聚四氟乙烯,中间层为金属丝编织的网或绕制的螺旋弹簧状,夕卜层为高分子聚合物聚酰亚胺、聚醚醚酮、尼龙、嵌段聚酰胺或聚氨酯。 [0011] The proximal end of the metal ring anchor of the present invention, the side, in the axial direction of the catheter, the outer layer is formed within the conduit hole-shaped cross section is wire lumen; non-curved section of the catheter, the wire cavity has a shaft to the support assembly, a metal cable support assembly disposed in the axial hole of the wire lumen and a non-curved section of the conduit bent pipe segment: the axial support assembly has an inner layer, an intermediate layer and an outer layer, the inner PTFE layer, an intermediate layer of woven wire mesh or wound coil spring-like, Xi Bu layer of polyimide polymer, PEEK, nylon, polyamide or polyurethane block. [0012] 本发明的手柄设有筒状的推杆和外手柄,推杆的近端伸进外手柄沿轴向的通孔远端的一段内,形成有阻尼滑动连接;所述外手柄通孔近端的一段内设有拉线固定装置,所述金属拉线的近端连接在拉线固定装置上。 The [0012] present invention is provided with the handle of the pusher and the outer cylindrical handle, the proximal end of the push rod axially extending into the outer handle section of the distal end of the through hole is formed damping slidably connected; through the outer handle There is a section of the proximal hole pull fixtures, the metal wire is connected to the proximal end of the cable fixture.

[0013] 本发明的推杆的外圆周上开有限位槽,限位槽的长度方向平行于推杆的轴线方向;所述外手柄上沿径向开有销孔,销孔内插入有限位销,限位销向内伸出销孔的一段插入限位槽内。 [0013] On the outer circumference of the push rod of the present invention, the opening of a finite bit slot, the longitudinal direction of the stopper groove parallel to the axial direction of the plunger; pin hole is opened radially on the outside handle, the pin insertion hole of a finite bit pins, inwardly projecting stopper pin insertion section of the pin hole limiting groove.

[0014] 一种可控弯导引导管的制备方法,包括以下步骤: [0014] A curved guide catheter controllable preparation method, comprising the steps of:

[0015] 一、制作轴向支撑组合件, [0015] First, the production axial support assembly

[0016] 内层米用聚四氟乙烯,内径为0.25mm〜2.5mm,厚0.02mm〜0.1mm,长度为40cm〜130cm ; [0016] m PTFE inner layer, an inner diameter of 0.25mm~2.5mm, thick 0.02mm~0.1mm, length 40cm~130cm;

[0017] 中间层采用丝径为0.0lmm〜0.1mm的不锈钢丝、钨丝、钴铬合金丝、钛合金丝或镍钛合金丝,丝数为8〜32根,编织成30〜200PPI的网,或转速为5〜20r/min,绕制成外径为0.3mm〜3.0mm,螺距为0.02mm〜0.2mm的螺旋弹簧状; [0017] The middle layer 0.0lmm~0.1mm wire diameter stainless steel wire, tungsten, cobalt-chromium alloy wire, titanium wire or nitinol wire, wire number 8~32 roots, woven mesh 30~200PPI , or speed of 5~20r / min, wound into an outer diameter of 0.3mm~3.0mm, pitch of the helical spring-like 0.02mm~0.2mm;

[0018] 外层采用高分子聚合物聚酰亚胺、聚醚醚酮、尼龙、嵌段聚酰胺或聚氨酯,外径为 [0018] The outer layer of polymer, polyimide, polyetheretherketone, nylon, polyamide or polyurethane blocks, outer diameter of

0.4mm 〜3.1mm ; 0.4mm ~3.1mm;

[0019] 将内层、中间层、夕卜层按层次套置在外径为0.25mm〜2.5mm,长度为40cm〜130cm的金属或塑料芯棒上,在外面套上内径为l.(T3.0mm,收缩比为1.3:广2:1的氟化乙烯丙烯共聚物热收缩管,流变温度38(T450 F,流变速度0.08、.25cm/s,自然冷却至室温后,剥掉热收缩管,拔出芯棒完成轴向支撑组合件的制作; [0019] The inner layer, an intermediate layer, Xi Bu layer hierarchically arranged in sets of an outer diameter of 0.25mm~2.5mm, a length of the 40cm~130cm metal or plastic mandrel, an inner diameter of the outside sleeve l. (T3. 0mm, contraction ratio of 1.3: Canton 2: fluorinated ethylene propylene copolymer heat-shrinkable tube 1, flow temperature 38 (T450 F, flow rate 0.08, .25cm / s, naturally cooled to room temperature, stripped of heat shrink tube, pull mandrel assembly complete axial support production;

[0020] 二、制作导管, [0020] Second, the production conduit,

[0021 ] 导管内层米用聚四氟乙烯管,内径为0.6mm〜6.0mm,厚0.02mm〜0.1mm,长600mm 〜1450mm ; [0021] m PTFE inner catheter tube, an inner diameter of 0.6mm~6.0mm, thick 0.02mm~0.1mm, length 600mm ~1450mm;

[0022] 导管中间层采用8〜32根丝径为0.02mm〜0.1mm不锈钢丝或镍钛合金丝,编织成30PPI〜100PPI的金属网; [0022] catheter middle layer 8~32 0.02mm~0.1mm filament diameter stainless steel wire or nitinol wire, woven into 30PPI~100PPI metal mesh;

[0023] 导管外层采用硬度为2〜72D的高分子聚合物材料嵌段聚酰胺、尼龙或聚氨酯管,外径为Imm〜7mm,导管弯曲段采用相对柔软的高分子聚合物管,长IOmm〜IOOmm ;导管非弯曲段采用硬度相对较高的高分子聚合物管,长600mm〜1400mm ; [0023] using the hardness of the outer catheter polymer material 2~72D block polyamide, nylon or polyurethane tube outer diameter Imm~7mm, conduit bending section with a relatively soft polymer tube, length IOmm~IOOmm; catheter unbent section with a relatively high hardness polymer tube, long 600mm~1400mm;

[0024] 显影标记采用钼铱合金、钼、金、钽、钨、含钨的高分子材料或含Bi2O3的高分子材料环,尺寸为0.6mm〜6.0mm ; [0024] The developing markers molybdenum iridium alloy, molybdenum, gold, tantalum, tungsten, tungsten-containing high-molecular material or a polymer material containing Bi2O3 ring size 0.6mm~6.0mm;

[0025] 金属环锚点采用不锈钢、镍钛合金或钼铱合金环,尺寸为0.6mm〜6.0mm ; [0025] metal ring anchor made of stainless steel, nickel, titanium or molybdenum iridium alloy ring, size 0.6mm~6.0mm;

[0026] 金属拉线米用丝径为0.1mm〜0.5mm的不锈钢丝或镍钛合金丝,长700mm〜1600mm ;将金属拉线的一端焊接在金属环锚点,焊接电流为75A〜200A,脉宽为2ms〜10ms,金属拉线的另一端穿过轴向支撑组合件; [0026] metal wire meter stainless steel wire with a wire diameter or nitinol wire 0.1mm~0.5mm and long 700mm~1600mm; the end of the weld metal in the metal ring anchor cable, welding current 75A~200A, pulse To 2ms~10ms, the other end of the metal wire through the axial support assembly;

[0027] (I)将导管内层套置在外径为0.6mm〜6.0mm,长度为600mm〜1450mm,沿轴线带 [0027] (I) a catheter disposed in an outer diameter of the inner sleeve 0.6mm~6.0mm, length 600mm~1450mm, along the axis with

有凹槽的金属芯棒上;(2)按顺序从远端,将显影标记、带金属拉线的金属环锚点套置在导管内层位于导管弯曲段的位置,显影标记和金属环锚点之间的距离为4mm〜30mm; (3)将轴向支撑组合件沿轴向设置在导管内层的导管非弯曲段的金属芯棒的凹槽位置;(4)将导管中间层套置在金属环锚点和轴向支撑组合件之外;(5)在导管中间层外套置导管外层,长IOmm〜IOOmm的导管外层套置在远端;(6)在导管外层外套上内径为1.3^9.5mm,收缩比为1.3^2:1的氟化乙烯丙烯共聚物热收缩管,流变温度38(T450 F,流变速度0.08、.25cm/s,自然冷却至室温后,剥掉热收缩管,拔出芯棒,得到导管; There are grooves on the core metal; metal ring anchor sleeve means (2) in order from the distal end, the developing marker, with a metal wire in the catheter inner curved section of the catheter position, the developing markers and metal ring anchor the distance between the 4mm~30mm; (3) the axial support assembly axially disposed in a recess position of the metal inner mandrel catheter catheter of non-curved section; (4) sets the intermediate layer disposed in the conduit anchor outside the metal ring and axial support assembly; (5) the outer jacket pipe set in the middle layer of the catheter, the catheter outer sheath IOmm~IOOmm long set at the far end; (6) the inner diameter of the catheter outer jacket for 1.3 ^ 9.5mm, contraction ratio of 1.3 ^ 2: 1 copolymer of fluorinated ethylene propylene heat shrinkable tube, flow temperature 38 (T450 F, flow rate 0.08, .25cm / s, naturally cooled to room temperature, stripped of heat shrinkable tube, pull rod, get the catheter;

[0028] 三、推杆、外手柄、限位销、拉线固定装置采用医用不锈钢材料,按现有机械加工方法制作; [0028] Third, the putter, outside handle, limit sales, cable fixtures using medical stainless steel, according to the existing machining method of making;

[0029] 四、组装,得到可控弯导引导管。 [0029] Fourth, the assembly, to obtain a controlled bending of the guiding catheter.

[0030] 本发明与现有技术相比,调节外手柄与拉推杆的相对位置,金属拉线被固定螺钉锁紧,相当于放松或拉紧金属拉线,导管弯曲段的远端发生弯曲变形,控制外手柄与推杆的相对位移,可以控制导管弯曲段远端的弯曲程度,实现导管远端弯曲可控,达到使用同一根导管可以进入左、右冠状动脉,缩短手术时间,减轻患者痛苦,提高冠状动脉介入治疗手术的安全性,也适合不同大小的心脏和不同开口的冠状动脉,结构紧凑,成本低。 [0030] The present invention compared to the prior art, adjusting the relative position of the outer handle and the pull-push rod, a metal wire is fixed locking screw, corresponds to relax or tighten the metal wire, the distal end of the catheter the curved section of the bending deformation, outside handle and control the relative displacement putter, you can control the degree of curvature of the distal end of the catheter curved section to achieve a controllable catheter distal bend, reach can use with a catheter into the left and right coronary arteries, shorter operative time, reduce patient pain, improve coronary intervention safety of surgery, but also for the heart of different sizes and different opening of the coronary arteries, compact, and low cost.

附图说明 Brief Description

[0031] 图1本发明实施例的结构示意图。 [0031] FIG schematic structural view of an embodiment of the invention.

[0032] 图2是本发明实施例的导管弯曲段被弯曲后示意图(一)。 [0032] FIG. 2 is a schematic view of a curved section after the example of the catheter is bent (a) embodiment of the present invention.

[0033] 图3是本发明实施例的导管弯曲段自由状态示意图(一)。 [0033] FIG. 3 is a section of the catheter is bent in a free state a schematic view of an embodiment of the present invention (a).

[0034] 图4是本发明实施例的导管弯曲段自由状态示意图(二)。 [0034] FIG. 4 is a section of the catheter is bent in a free state a schematic view of an embodiment of the present invention (II).

`[0035] 图5是本发明实施例的导管弯曲段和导管非弯曲段的结构示意图。 `[0035] FIG. 5 is a schematic structural view of an example of catheter curved section and a non-curved sections of the catheter embodiment of the present invention.

[0036] 图6是图5的AA剖视图。 [0036] FIG. 6 is a sectional view AA of Figure 5.

[0037] 图7是图2的BB剖面图。 [0037] FIG. 7 is a sectional view BB of Figure 2.

[0038]图8是本发明实施例的轴向支撑组合件的结构示意图。 [0038] FIG. 8 is a schematic structural view of embodiment of the present invention, an axial support assembly embodiment.

[0039] 图9是本发明实施例的手柄结构示意图。 [0039] FIG. 9 is a schematic structural view of a handle embodiment of the present invention.

具体实施方式 DETAILED DESCRIPTION

[0040] 下面结合附图和实施例对本发明作进一步详细说明。 [0040] accompanying drawings and the following embodiment of the present invention will be further described in detail. 在说明书附图中各附图标记为:可控弯导引导管1,导管接头2,外手柄3,推杆4,固定螺钉5,导管非弯曲段6,导管弯曲段7,金属拉线8,显影示标9,金属环锚点10,导管内层11,导管中间层12,导管外层13,轴向支撑组合件14,拉线腔15,导管腔16,轴向支撑组合件内层17,轴向支撑组合件中间层18,轴向支撑组合件外层19,推杆内腔20,限位槽21,阻尼圈22,限位销23,通孔24,拉线固定装置25,导管通道26,拉线通道27。 In the drawings, the specification for the respective reference numerals: a controlled bending of the guiding catheter 1, the catheter connector 2, the outer handle 3, push rod 4, fixing screw 5, the non-curved section conduit 6, the curved conduit section 7, a metal wire 8, 9 illustrates a developing standard, the metal ring anchor 10, inner conduit 11, the conduit of the intermediate layer 12, the outer conduit 13, the axial support assembly 14, a cable lumen 15, the catheter lumen 16, the inner support assembly 17 axially axial support assembly intermediate layer 18, the outer axial support assembly 19, the lumen of the pusher 20, the stopper groove 21, the damping ring 22, the stopper pin 23, the through hole 24, the cable fixing device 25, the duct channel 26, cable channel 27.

[0041] 如图1所示,本发明的可控弯导引导管1,从近端至远端,由导管接头2、手柄和导管顺序连接构成。 [0041] As shown in Figure 1, the present invention is controllable curved guiding catheter 1, from the proximal end to the distal end, the catheter connector 2, the handle and catheter are sequentially connected constituted. 导管为管状,长度为600mm〜1450mm,内径为0.6mm〜6.0mm,外径为Imm〜7_,由位于远端一段的导管弯曲段7和与导管弯曲段7连接的导管非弯曲段6两部分连接构成,导管弯曲段7长度为20mm〜100mm。 Catheter tube, a length of 600mm~1450mm, an inner diameter of 0.6mm~6.0mm, an outer diameter of Imm~7_, conduit by the non-curved section located at the distal section of the catheter and the catheter curved section 7 connected curved sections 7 of two parts 6 connected to form, the length of the catheter curved section 7 20mm~100mm. 导管弯曲段7的远端端部套置有显影示标9,显影示标9的近端一侧附近套置有金属环锚点10。 The distal end portion of the curved conduit section 7 is set with a developing sleeve shown marked 9, developing standard shown near the proximal end of the side cover 9 is set anchor 10 has a metal ring. 导管内设有金属拉线8,金属拉线8远端与金属环锚点10焊接连接,近端固定连接在手柄上。 Conduit equipped with a metal wire 8, the distal end of the metal wire 8 and the metal ring 10 anchors welded connection, a proximal end fixedly connected to the handle.

[0042] 如图2所示,导管弯曲段7在自由状态为直线状,导管弯曲段7的远端可由医生操作控制被弯曲,被弯曲的角度为:0 <角度< 270。 [0042] As shown in Figure 2, catheter curved section 7 in the free state is straight, curved distal catheter section 7 of the operation control to be bent by a physician, the bent angle is: 0 <angle <270 .

[0043] 如图3所示,导管弯曲段7在显影示标9与金属环锚点10之间的部分,在自由状态为弯曲状,弯曲呈90,可以为O <角度彡90,被弯曲的角度为:0 <角度彡270,被弯曲的方向与导管弯曲段7在自由状态弯曲的方向相反。 Part [0043] Figure 3 catheter curved section 7 shown in the developing standard 9 and the metal ring 10 between the anchor, in the free state in a curved shape, bent at 90 , for O <angle 彡 90 , bent angle: 0 <angle 彡 270 , the catheter is bent in the direction opposite to the curved section 7 is bent in the direction of a free state.

[0044] 如图4所示,在导管弯曲段7和导管非弯曲段6的连接处,在自由状态为弯曲状,弯曲呈90,可以为O <角度彡90,被弯曲的角度为:0<角度彡270,被弯曲的方向与导管弯曲段7在自由状态弯曲的方向相反。 [0044] 4, the curved section of the catheter 7 and the catheter 6 at the non-curved sections of the connection, in the free state in a curved shape, bent at 90 , for O <彡 angle of 90 , the bent angle : 0 <angle 彡 270 , opposite to the bending direction 7 is bent in the direction of the curved conduit segment in the free state.

[0045] 如图5所示,导管弯曲段7和导管非弯曲段6由三层结构构成,分别为导管内层 [0045] shown in Figure 5, the conduit 7 and conduits non-curved section curved section 6 three-layer structure constituted by, respectively, the inner conduit

11、导管中间层12和导管外层13,导管外层13套置在导管内层11外,导管中间层12嵌入在导管外层13内。 11, the outer conduit 12 and conduit intermediate layer 13, the catheter 11 disposed in the outer sleeve 13 outside the inner conduit, the conduit of the intermediate layer 12 is embedded within the catheter outer layer 13. 导管内层11采用聚四氟乙烯,使导管具有光滑的内腔16,导管内层11内径为0.6mm〜6.0mm,厚0.02mm〜0.1mm。 PTFE inner catheter 11, the catheter has a smooth inner lumen 16, an inner diameter of the catheter inner layer 11 0.6mm~6.0mm, thick 0.02mm~0.1mm. 导管中间层12为金属丝不锈钢或镍钛合金丝编织网,丝径为0.02mm〜0.1mm,密度为30PPI〜100PPI(每英寸目数),金属丝编织网使导管具有优良的抗折性能。 Catheter intermediate layer 12 is a metal wire stainless steel or nitinol wire cloth, wire diameter 0.02mm~0.1mm, density 30PPI~100PPI (mesh per inch) wire braid catheter with excellent bending properties. 导管外层13采用硬度为2〜72D的高分子聚合物材料嵌段聚酰胺、尼龙或聚氨酯,分别构成导管弯曲段7和导管非弯曲段6。 Conduit outer layer 13 using hardness 2~72D high polymer material block amide, nylon or polyurethane, respectively, constitute the conduit and the conduit 7 a non-curved section curved section 6. 导管弯曲段7采用相对柔软的高分子聚合物材料,如硬度为25D,导管非弯曲段6采用硬度相对较高的高分子聚合物材料,如硬度为72D。 Catheter curved section 7 uses a relatively soft polymer material, such as hardness of 25D, a non-curved section conduit 6 a hardness relatively high polymer materials, such as hardness of 72D. 导管外层13的外径为Imm〜7mm。 The outer diameter of the outer conduit 13 Imm~7mm. 显影示标9采用环状的钼铱合金、钼、金、钽、钨、含钨的高分子材料或含Bi2O3的高分子材料。 9 illustrates the use of an annular developing standard molybdenum iridium alloy, molybdenum, gold, tantalum, tungsten, tungsten-containing high-molecular material or a polymer material containing Bi2O3. 金属环锚点10为不锈钢、镍钛合金或钼铱合金环。 Metal ring anchor 10 is stainless steel, nickel-titanium or molybdenum iridium alloy ring. 显影示标9嵌入在导管弯曲段7远端端部的导管外层13内,金属环锚点10嵌入在显影示标9近端一侧附近的导管外层13内,金属环锚点10与显影示标9之间的距离为4mm〜30mm。 9 illustrates a developing standard embedded within the catheter outer catheter distal end curved sections 7 of 13, the metal ring 10 is embedded within the catheter anchor near the outer proximal end side of the developing show superscript 9 13, metal ring 10 and the anchor 9 shows the distance between the developing labeled 4mm~30mm. 在金属环锚点10的近端一侧开始,沿导管的轴向方向,导管内层11和导管中间层12之间、导管外层13内形成有截面为圆孔状的拉线腔15。 In the metal ring 10 of the anchor proximal end side of the start, in the axial direction of the conduit, the inner conduit 11 and the conduit 12 between the intermediate layer, the inner conduit outer layer 13 is formed with a circular hole-shaped cross section wire lumen 15. 在导管非弯曲段6,拉线腔15内设有轴向支撑组合件14。 6 non-curved section of the catheter, the cable chamber 15 equipped with axial support assembly 14. 金属拉线8的远端焊接连接在金属环锚点10上,金属拉线8经导管弯曲段7的拉线腔15,导管非弯曲段6的轴向支撑组合件14内孔,近端与外手柄3连接。 Metal welding wire 8 is connected to the distal end of the anchor metal ring 10, the metal wire cable bent section 8 via a conduit 15 of chamber 7, the support assembly 14 within the axial bore of non-curved section conduit member 6, the proximal end of the outer handle 3 connection. 轴向支撑组件14可以吸收金属拉线8拉伸时对非弯曲段6轴向压力,避免导管非弯曲段6发生弯曲变形。 Axial support assembly 14 can absorb the pressure of the non-metal wire bent section 6 8 axially stretched, the curved portion 6 to avoid the occurrence of the non-conduit bending deformation. 导管非弯曲段6的近端开有口,用于金属拉线8从导管非弯曲段6近端伸出。 Non-curved proximal catheter opening mouth portion 6 for metal wire 8 extending from the proximal end of the catheter the non-curved section 6.

[0046] 如图6所示,导管内层11形成的圆筒形内腔16,沿轴线一侧壁向圆心内外凸,形成面对导管外层13的凹陷,导管外层13向凹陷处外凸,截面为圆形的拉线腔15位于外凸与凹陷之间。 [0046] As shown in Figure 6, the cylindrical cavity 11 formed in the inner conduit 16, to the center axis of the inner and outer ledge of a side wall, forming the recess 13 in the outer face of the conduit, the outer conduit 13 to the outside of the depression convex, circular cross-section wire lumen 15 is located between the convex and recess. 如图7所示,轴向支撑组合件14埋设在导管非弯曲段6的拉线腔15内。 As shown in Figure 7, the axial support assembly 14 embedded in a non-curved section within the catheter lumen 6 of the cable 15. 拉线腔15位于外凸与凹陷之间的结构使得在导管弯曲段7可控被弯曲的同时,不增加导管整体 Wire lumen 15 is located between the recess convex structure such that the curved section of the catheter 7 is controlled while bending, without increasing the overall catheter

的壁厚。 Wall thickness.

[0047] 如图8所示,轴向支撑组合件14由三层结构套置构成,分别为内层17、中间层18和外层19。 [0047] shown in Figure 8, the axial support assembly 14 constituted by a three-layer structure is sleeved, respectively an inner layer 17, intermediate layer 18 and outer layer 19. 内层17米用聚四氟乙烯,内径为0.25mm〜2.5mm,厚0.02mm〜0.1mm。 PTFE inner 17 meters, diameter of 0.25mm~2.5mm, thick 0.02mm~0.1mm. 中间层18为金属丝不锈钢丝、钨丝、钴铬合金丝、钛合金丝或镍钛合金丝编织的网或绕制的螺旋弹簧状。 Intermediate layer 18 is a metal wire stainless steel wire, tungsten wire, cobalt-chromium alloy wire, titanium or nickel-titanium wire mesh or woven wire wound coil spring-like. 金属丝的丝径为0.0lmm〜0.1mm,编织网的密度为30PPI〜200PPI,螺旋弹簧状外径为0.3mm〜3.0mm,螺距为0.02mm〜0.2mm。 Wire wire diameter 0.0lmm~0.1mm, density braid of 30PPI~200PPI, coil spring-like outer diameter 0.3mm~3.0mm, pitch 0.02mm~0.2mm. 外层19为高分子聚合物聚酰亚胺、聚醚醚酮、尼龙、嵌段聚酰胺或聚氨酯,外径为0.4mm〜3.1mm。 The outer layer 19 is a polyimide polymer, polyetheretherketone, nylon, polyamide or polyurethane blocks, an outer diameter of 0.4mm~3.1mm. 轴向支撑组合件14的内径大于金属拉线8的外径,可以保证金属拉线8的顺畅通过。 The inner diameter of the axial support assembly 14 is greater than the outer diameter of the metal wire 8, you can ensure a smooth metal wire through 8.

[0048] 金属拉线8采用丝径为0.1 mm〜0.5mm的不锈钢丝或镍钛合金丝。 [0048] 8 metal wire using a wire diameter of 0.1 mm~0.5mm of stainless steel wire or nitinol wire.

[0049] 如图9所示,手柄设有推杆4和外手柄3,推杆4和外手柄3形成沿轴向的滑动连接。 [0049] As shown in Figure 9, the handle has a push rod 4 and the outer handle 3, the handle 3 and the outer push rod 4 is formed along the axial direction of the sliding contact. 推杆4的近端伸进外手柄3沿轴向的通孔远端的一段内。 Section of the proximal end of push rod 4 projects into the outer handle 3 in the axial direction of the distal end of the through hole. 推杆4形状为圆筒状,导管非弯段6穿过推杆4沿轴线的内腔(内孔)20,被固定在推杆4上。 Push rod 4 is cylindrical shape, the non-bending portion 6 through the catheter the push rod 4 along the axis of the lumen (inner bore) 20 is fixed to the push rod 4. [0050] 在推杆4的远端的外圆周上通过机械加工形成向外一周的凸起,凸起用于医生操作时方便推出或拉进推杆4。 [0050] In the distal end of the pusher 4 is machined to form the outer circumference of the outward protrusion of the week, the projections used to facilitate the introduction or pulled into putting four doctors to operate. 在推杆4的中部和近端外圆周上分别开有两个环形槽,用于嵌入阻尼圈22,增加推杆4和外手柄3内孔之间的阻尼,防止导管弯曲段7被弯曲的过程中,推杆4向近端方向移动。 On the proximal end of the outer circumference of the push rod and the central opening 4 has two annular grooves, respectively, for embedding the damping ring 22, increasing the damping ram 4 and the outer bore between the handle 3, 7 to prevent the curved section of the catheter to be bent process, the push rod 4 is moved in the proximal direction. 在推杆4的外表面、两个环形槽之间开有一个矩形形状的限位槽21,矩形限位槽21的长度方向平行于推杆4的轴线方向,用于外手柄3上连接的限位销23向内伸出外手柄3销孔的一段插入其中,使限位销23可以在限位槽21内沿其长度方向活动,限制推杆4相对外手柄3轴线移动的行程。 The outer surface of the push rod 4, there is an opening between the two annular grooves of rectangular shape restraint slots 21, the longitudinal direction of the rectangular groove 21 of the stopper is parallel to the axial direction of the push rod 4 for connecting the outer handle 3 inwardly projecting stopper pin 23 the outer handle section of the pin holes 3 inserted therein, so that the stopper pin 23 along its longitudinal direction can be active within the limiting groove 21, the push rod 4 relative to the outer limits of the stroke movement of the handle 3 axis.

[0051] 外手柄3形状为圆筒状,在外手柄3的远端部分、推杆4伸入其通孔的位置,在圆筒的壁上沿径向开有销孔,用于插入限位销23,限位销23向内伸出销孔的一段插入限位槽21内。 [0051] the outer shape of the handle 3 has a cylindrical shape, the outer distal end of handle portion 3, the position of its push rod 4 extends through holes in the wall of the cylinder opening radially has a pin hole for inserting the stopper pin 23, the stopper pin 23 inwardly projecting stopper pin inserted into the hole section of the groove 21. 外手柄3的近端部分,通孔内设置有一个拉线固定装置25,拉线固定装置25与外手柄3在通孔内形成可拆卸的连接,如螺纹连接、两端内置卡圈或凸台与内置卡圈的配合。 The outer proximal end of handle portion 3, the through-hole is provided with a cable securing means 25, securing means 25 and the outer pull handle (3) through holes formed in a detachable connection, such as a threaded connection, both ends of the built-in collar or mesas and Built with the collar. 拉线固定装置25形状为柱状,在拉线固定装置25上沿其轴线设有两个通道(通孔),分别为与外手柄3轴线同轴的导管通道26和与外手柄3轴线平行的拉线通道27。 Wire 25 is cylindrical shape of the fixing means, the fixing means 25 is provided with two cable channels (through holes) along its axis, respectively with the outer handle coaxial with the axis of the duct channel 3 and the outer handle 26 parallel to the axis of the cable channel 3 27. 在外手柄3壁和拉线固定装置25的拉线通道27的外侧壁,沿外手柄3的径向,开有螺孔,用于旋入固定螺钉5,固定螺钉5的端部附近开有与固定螺钉5轴线垂直的通孔24,固定螺钉5旋入外手柄3和拉线固定装置25的螺孔时,通孔24与拉线通道27连通。 Pull handle 3 and the outer wall of the cable channel 25 of the fixture outer side wall 27, radially outer handle 3, a screw hole opened for screwing fixing screws 5, near the end of the fixing screw 5 is opened and the fixing screws the vertical axis 24 of the through holes 5, the outer fixing screw 5 is screwed into the screw holes 3 and the wire fixing lever device 25, through holes 24 communicating with the wire passage 27. 导管非弯曲段6的近端经推杆4的内腔、导管通道26伸出外手柄3,与导管接头2连接。 The proximal end of the catheter through the non-curved section 6 putter cavity 4, conduit channel 26 extends outside handle 3, 2 and conduit fitting connection. 金属拉线8从导管非弯曲段6的近端开口伸出,经拉线通道27并穿过固定螺钉5的通孔24。 Metal wire 8 extending from the proximal end opening of the non-curved section 6 of the catheter, through the cable passage 27 and through the through-hole 5 of the fixing screws 24. 将固定螺钉5旋转一定的角度可将金属拉线8固定锁紧在外手柄3上。 5 Turn the fixing screws can be angled metal cable 8 fixed outer locking handle 3.

[0052] 导管接头2采用标准的鲁尔接头。 [0052] 2 conduit fitting with standard luer connector.

[0053] 医生手术时,一手握住外手柄3,另一手向前(远端)推或向后(近端)拉推杆4,因金属拉线8的近端被固定螺钉5锁紧,相当于放松或拉紧金属拉线8,导管非弯曲段6不产生波浪形或弧形弯曲,导管弯曲段7的远端发生弯曲变形,控制外手柄3与推杆4的相对位移,可以控制导管弯曲段7远端的弯曲程度,实现导管远端弯曲可控,达到使用同一根导管可以进入左、右冠状动脉,缩短手术时间,减轻患者痛苦,提高冠状动脉介入治疗手术的安全性,也适合不同大小的心脏和不同开口的冠状动脉。 When the [0053] doctors surgery, one hand holding the outside handle 3, another hand forward (distal) push or backward (proximal) pull putt 4, due to the proximal end of the metal wire 8 is fixed locking screw 5, quite to relax or tighten the metal wire 8, the catheter does not produce a non-curved section 6 curved wavy or bent, the distal end of the catheter the curved section 7 of bending deformation, the relative displacement of the control lever 3 and the outer push rod 4, the control conduit can be bent degree curved distal section 7, to achieve controllable catheter distal bend, reach a catheter can use the same into the left and right coronary arteries, shorter operative time, reduce patient suffering, improve coronary intervention surgery safety, but also for different heart size and different opening of the coronary arteries. 本发明的可控弯导引导管不明显增加导管的壁厚,结构紧凑,成本低。 Controllable curved guide catheter of the present invention is not obvious increase in the wall thickness of the catheter, compact, and low cost.

[0054] 本发明的可控弯导引导管的制备方法,包括以下步骤: [0054] The controllable bending of the present invention the preparation of the guiding catheter, comprising the steps of:

[0055] 一、制作轴向支撑组合件, [0055] First, the production axial support assembly

[0056] 内层米用聚四氟乙烯,内径为0.25mm〜2.5mm,厚0.02mm〜0.1mm,长度为40cm〜130cmo [0056] m PTFE inner layer, an inner diameter of 0.25mm~2.5mm, thick 0.02mm~0.1mm, length 40cm~130cmo

[0057] 中间层材料釆用丝径为0.0lmm〜0.1mm的不锈钢丝、鹤丝、钴络合金丝、钛合金丝或镍钛合金丝,丝数为8〜32根,编织成30〜200PPI的网,采用格兰达技术(深圳)有限公司制造的编织机,转速70〜180r/min。 [0057] interlayer material 0.0lmm~0.1mm preclude the use of wire diameter stainless steel wire, wire crane, cobalt complex gold, titanium or nickel titanium wire and silk number 8~32 root, woven into 30~ 200PPI the network, using Granda Technology (Shenzhen) Co., Ltd. Manufacturing of knitting machines, speed 70~180r / min. 或米用美国RothGreaves&Associates Inc公司的L80弹簧机,转速为5〜20r/min,绕制成外径为0.3mm〜3.0mm,螺距为0.02mm〜0.2mm的螺 Or rice with American RothGreaves & Associates Inc's L80 spring machine, speed is 5~20r / min, about having an outer diameter of 0.3mm~3.0mm, screw pitch 0.02mm~0.2mm

旋弹簧状。 Spring-like spin.

[0058] 外层材料为高分子聚合物聚酰亚胺、聚醚醚酮、尼龙、嵌段聚酰胺或聚氨酯,外径为0.4mm 〜3.1mm0 [0058] The outer layer of polymer material is polyimide, polyetheretherketone, nylon, polyamide or polyurethane blocks, an outer diameter of 0.4mm ~3.1mm0

[0059] 将内层、中间层、夕卜层按层次套置在外径为0.25mm〜2.5mm,长度为40cm〜130cm的金属或塑料芯棒上,在外面套上内径为l.(T3.0mm,收缩比为1.3:f 2:1的氟化乙烯丙烯共聚物FEP热收缩管,用美国USA AT INC公司的Reflow-22 03-44型流变机将三者熔合在一起,流变温度38(T450 F,流变速度0.08、.25cm/s,自然冷却至室温后,剥掉热收缩管,拔出芯棒完成轴向支撑组合件14的制作。 [0059] The inner layer, an intermediate layer, Xi Bu layer hierarchically arranged in sets of an outer diameter of 0.25mm~2.5mm, a length of the 40cm~130cm metal or plastic mandrel, an inner diameter of the outside sleeve l. (T3. 0mm, contraction ratio of 1.3: f 2: 1 copolymer of fluorinated ethylene propylene FEP heat shrinkable tube, with the United States USA AT INC's Reflow-22 03-44 rheological machine three fused, the rheological temperature 38 (T450 F, flow rate 0.08, .25cm / s, naturally cooled to room temperature, stripped of heat shrinkable tube, complete axial pull mandrel support assembly 14 is produced.

[0060] 二、制作导管, [0060] Second, the production conduit,

[0061] 导管内层米用聚四氟乙烯管,内径为0.6mm〜6.0mm,厚0.02mm〜0.1mm,长600mm 〜1450mm。 [0061] m PTFE inner catheter tube, an inner diameter of 0.6mm~6.0mm, thick 0.02mm~0.1mm, length 600mm ~1450mm.

[0062] 导管中间层采用8〜32根丝径为0.02mm〜0.1mm不锈钢丝或镍钛合金丝,编织成30PPI〜100PPI的金属网,用格兰达技术(深圳)有限公司的编织机,转速7(Tl80r/min。 [0062] catheter middle layer 8~32 0.02mm~0.1mm filament diameter stainless steel wire or nitinol wire, woven into 30PPI~100PPI metal mesh, with Granda Technology (Shenzhen) Co., knitting machines, Speed 7 (Tl80r / min.

[0063] 导管外层采用硬度为2〜72D的高分子聚合物材料嵌段聚酰胺、尼龙或聚氨酯管,外径为Imm〜7mm。 [0063] using the hardness of the outer catheter polymer material 2~72D block polyamide, nylon or polyurethane tube outer diameter Imm~7mm. 导管弯曲段采用相对柔软的高分子聚合物管,如硬度为25D,长IOmm〜100mm。 Pipe bending section with a relatively soft polymer tube, such as hardness of 25D, long IOmm~100mm. 导管非弯曲段采用硬度相对较高的高分子聚合物管,如硬度为72D,长600mm 〜14:00mm。 Non-curved conduit section with relatively high hardness polymer tube, such as the hardness of 72D, length 600mm ~14: 00mm.

[0064] 显影标记采用香港庄信万丰贵金属有限公司的钼铱合金、钼、金、钽、钨、含钨的高分子材料或含Bi2O3的高分子材料环,尺寸为0.6mm〜6.0mm。 [0064] The developing mark iridium alloy molybdenum Johnson Matthey Hong Kong Limited, molybdenum, gold, tantalum, tungsten, tungsten-containing polymer material or polymer material containing Bi2O3 ring size 0.6mm~6.0mm.

[0065] 金属环锚点采用扬州锦仪精密管材有限公司的不锈钢、镍钛合金或钼铱合金环,尺寸为0.6臟〜6.0mmn [0066] 金属拉线米用丝径为0.1mm〜0.5mm的不锈钢丝或镍钛合金丝,长700mm〜1600mm。 [0065] using a metal ring anchor Yangzhou Kam Yee Precision Tubing Co., stainless steel, nickel-titanium or molybdenum iridium alloy ring, size 0.6 dirty ~6.0mmn [0066] metal wire with a wire diameter of 0.1mm~0.5mm meters of stainless steel wire or nitinol wire, long 700mm~1600mm. 将金属拉线的一端焊接在金属环锚点,采用武汉楚天工业激光设备有限公司的激光焊接机,焊接电流为75A〜200A,脉宽为2ms〜IOms,金属拉线的另一端穿过轴向支撑组合件。 The end of the weld metal in the metal ring pull anchor, using Wuhan Chutian Industrial Laser Equipment Co. laser welding machines, welding current 75A~200A, pulse width 2ms~IOms, the other end of the metal wire through axial support assembly.

[0067] (I)将导管内层套置在外径为0.6mm〜6.0mm,长度为600mm〜1450mm,沿轴线带 [0067] (I) a catheter disposed in an outer diameter of the inner sleeve 0.6mm~6.0mm, length 600mm~1450mm, along the axis with

有凹槽的金属芯棒上。 There are grooves on the metal mandrel. (2)按顺序从远端,将显影标记、带金属拉线的金属环锚点套置在导管内层位于导管弯曲段的位置,显影标记和金属环锚点之间的距离为4mm〜30mm。 (2) order from the remote, the development marks a metal ring with a metal cable anchor sleeved inner catheter is positioned in the curved section of the catheter from developing between the anchor tags and metal rings for 4mm~30mm. (3)将轴向支撑组合件沿轴向设置在导管内层的导管非弯曲段的金属芯棒的凹槽位置。 (3) the axial support assembly axially disposed in the groove position of the metal inner mandrel catheter catheter of non-curved section. (4)将导管中间层套置在金属环锚点和轴向支撑组合件之外。 (4) The middle layer of the catheter sheath anchor position outside the metal ring and axial support assembly. (5)在导管中间层外套置导管外层,长IOmm〜IOOmm的导管外层套置在远端。 (5) the jacket conduit is set in the outer conduit of the intermediate layer, length IOmm~IOOmm catheter outer sheath disposed in a distal end. (6)在导管外层外套上内径为1.3^9.5mm,收缩比为1.3^2:1的氟化乙烯丙烯共聚物FEP热收缩管,用美国USA AT INC公司的Reflow-2203-44型流变机将导管各层熔合在一起,流变温度38(T450 0F,流变速度0.08〜0.25cm/s,自然冷却至室温后,剥掉热收缩管,拔出芯棒,得到导管。 (6) in the outer jacket on the conduit inner diameter of 1.3 ^ 9.5mm, contraction ratio of 1.3 ^ 2: fluorinated ethylene propylene copolymer FEP heat shrinkable tube 1, with the United States USA AT INC's type flow Reflow-2203-44 Variable Machine catheter layers fused together, rheology temperature 38 (T450 0F, rheological speed 0.08~0.25cm / s, naturally cooled to room temperature, stripped of heat shrinkable tube, pull out the mandrel to give the catheter.

[0068] 三、推杆、外手柄、限位销、拉线固定装置和固定螺钉采用医用不锈钢材料,按现有机械加工方法制作。 [0068] Third, the putter, outside handle, limit sales, cable fixtures and the use of medical stainless steel fixing screws, according to the existing method of production machining. 导管接头为外购的标准鲁尔接头。 Conduit connector for a standard luer purchased.

[0069] 四、组装,将导管近端从推杆远端的孔装入并伸出推杆,用AB胶将导管与推杆粘接固定,将拉线固定装置装入外手柄近端的通孔(内腔),将伸出推杆的导管通过拉线固定装置的导管通道,同时金属拉线通过拉线固定装置的拉线通道,并穿过固定螺钉上的通孔,将外手柄近端从推杆远端开始套置在推杆上,限位销从外手柄的销孔插入并伸进限位槽,旋转固定螺钉即可固定金属拉线。 [0069] Fourth, the assembly, the proximal end of the catheter distal from the hole and extend into the putter putter, with AB glue bonding and fixing the catheter and putting the cable into the fixture through the proximal end of the outer handle hole (lumen), the push rod extending through the cable conduit channel catheter fixing device, while the metal wire is fixed by means of wire cable channel, and through the through holes on the fixing screw, the outer handle from the proximal end of the push rod began to set placed on the distal pusher, limit stopper pin is inserted into his groove and pin hole from the outside of the handle, rotate the fixing screws can be fixed metal cable. 在伸出外手柄的导管近端用AB胶将导管近端与导管接头粘接。 At the proximal end of the catheter extending outside of the handle with the proximal end of the catheter AB glue adhesive joints with duct. AB胶为M-3ICL乐泰环氧AB胶。 AB glue for M-3ICL Loctite epoxy glue AB.

[0070] 实施例,可控弯导引导管的外径为2.33mm,有效长度(导管露出手柄的长度)为1000mm,导管弯曲段在自由状态下呈90弯曲,导管非弯曲段在自由状态下呈直线状态,导管远端的最大弯曲角度为270。 [0070] Example, controlled bending of the guiding catheter having an outer diameter 2.33mm, the effective length (length of the catheter to expose the handle) is 1000mm, the catheter the curved section in a free state, 90 bend, a non-curved section conduit in the free state Under the linear state, the maximum bending angle of the distal end of the catheter is 270 .

[0071] 动物试验,选用体重20公斤犬一只,该犬左右冠脉狭窄,采用本实施例的可控弯导引导管及配套的扩张管、2.0mmX 20mm PTCA (经皮冠状动脉腔内血管成形术Percutaneoustransluminal coronary angioplasty)球囊导管及配用导丝(0.014",195cm)、超硬导丝(0.035",260cm)、穿刺鞘、Y接头附属配件一套。 [0071] animal testing, the choice of a dog weighing 20 kg, about the dog coronary stenosis, according to this embodiment of a controlled bending and supporting the expansion of the guiding catheter tube, 2.0mmX 20mm PTCA (percutaneous transluminal coronary endovascular Angioplasty Percutaneoustransluminal coronary angioplasty) balloon catheter and guidewire with (0.014 ", 195cm), super-hard guide wire (0.035", 260cm), puncture sheath, Y connector accessories set. 经股动脉穿刺,将超硬导丝送入冠脉入口附近位置;将扩张管从可控弯导引导管的接头插入,观看可控弯导引导管的显影示标,将扩张管与可控弯导引导管的组合沿着超硬导导丝送入冠脉入口附近位置;撤出超硬导丝和扩张管,在可控弯导引导管的接头连接一个Y接头,调整导管在血管中的位置,使远端90弯曲段背向冠脉入口,由于拉线的远端由金属环锚点固定在导管远端,近端通过拉线固定装置用固定螺钉固定在外手柄上,当手心握住外手柄,大拇指向远(前)端推送,或向近(后)端拉推杆,即可改变导管远端的导管弯曲段的弯曲程度,大拇指往前推送推杆至最远位置,此时外手柄上的限位销滑动至推杆限位槽的近端,远端弯曲段呈最大270弯曲,慢慢回拉推杆,使导管的远端端口进入至冠脉入口;从Y接头的侧孔经可控弯导引导管注入造影剂到冠脉,确认冠脉狭窄位置;将0.014",195cm导丝从Y接头的正孔进入,沿着可控弯导引导管进入冠脉并穿过血管狭窄位置^fPTCA球囊导管沿着0.014",195cm导丝进入到冠脉狭窄位置,并使球囊两端的显影标记位于狭窄位置的两端,充盈球囊,对血管狭窄位置进行扩张;扩张完毕后收缩球囊,将PTCA球囊导管连同0. 014",195cm导丝一同撤出;扭动推杆使可控弯导引导管旋转一定的角度,并按照上述方法使可控弯导引导管使其进入至另一个冠脉入口位置,按照上述方法重新进入0.014",195cm导丝和PTCA球囊导管并对血管狭窄位置进行球囊扩张;扩张完毕后将球囊导管收缩并退至可控弯导引导管,并连可控弯导引导管一同撤出体外。 Through the femoral artery puncture, the super-hard guide wire into the coronary artery location near the entrance; the expansion tube is inserted into the guide catheter from the controllable joints bend, bend controlled watch shows marked developing guiding catheter, the expansion tube and controllable composite curved guide catheter along the guide wire into the coronary superhard guide position near the entrance; the withdrawal of superhard guidewire and expansion tube, bent in a controlled guiding catheter connected to a Y connector fitting, adjusting the catheter in a blood vessel position, so that the distal end 90 curved section facing away from the entrance of coronary artery, due to the distal end of the cable by a metal ring fixed to the distal anchor, through the proximal end of the cable fixing device fixing screws of the outer handle, when the palm of the hand holding the outside handle, thumb to the far (front) side push, or to almost (rear) side pull putt, you can change the degree of curvature of the curved distal catheter segment, putting the thumb to push forward to the farthest position At this stop pin on the slide to the outside handle putter slot limit proximal and distal curved segment was the largest 270 bend, pull the putter back slowly, so that the distal end of the catheter to the coronary inlet port access; from Y connector side of the hole through the guiding catheter curved controlled injection of contrast agent into the coronary artery stenosis confirmed position; the 0.014 ", 195cm guide wire into the hole from the positive Y connector, along curved guide catheter into controllable crown veins and through the stenosis position ^ fPTCA balloon catheter along the 0.014 ", 195cm guidewire into the coronary stenosis position, and developing markers are located at both ends of the balloon at both ends, filling the balloon narrow position, the position of vascular stenosis expanding; contraction after balloon dilatation is finished, the PTCA balloon catheter, together with 0. 014 ", 195cm guidewire withdrawn together; twist ram guide catheter so that the controllable bent at an angle of rotation, and in accordance with the method described above can be control bend it into the guide catheter coronary entrance to another location, in accordance with the above method to re-enter 0.014 ", 195cm and PTCA balloon catheter guidewire and balloon dilatation of vascular stenosis position; shrink after balloon dilation is complete and retreat controllable bent guiding catheter and guide catheter bend controllable even with the withdrawal of the body. 通过造影方法观察先前血管狭窄位置的血流情况,血流通畅,完成此次冠脉狭窄球囊扩张的手术过程。 Stenosis position previously observed by angiography blood flow, blood flow, completion of the coronary stenosis balloon dilatation of the surgical procedure.

[0072] 本实施例中,本发明的可控弯导引导管用于配合球囊扩张手术,在诊断或治疗中需要将其他器械如支架、导丝、球囊方便的送入到冠脉,都可采用本发明的可控弯导引导管。 [0072] In the present embodiment, the present invention is a controllable bending guide catheter with balloon angioplasty is used in the diagnosis or treatment of other devices such as the need to support, guide wire, balloon conveniently fed to coronary, According to the present invention can be controlled curved guiding catheter.

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Classifications
International ClassificationA61M25/088, A61M25/098
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