技术领域technical field
本实用新型涉及医疗器械技术领域，具体地说是一种头端与球囊之间设有柔性连接部的球囊导管。The utility model relates to the technical field of medical devices, in particular to a balloon catheter with a flexible connection between a head end and a balloon.
背景技术Background technique
经皮冠状动脉介入治疗(Percutaneous Coronary Intervention，PCI)，是指经心导管技术疏通狭窄甚至闭塞的冠状动脉管腔，从而改善心肌的血流灌注的治疗方法。该治疗方法具有疗程短、创伤小、疗效显著等优点，近年来发展迅速。依据实施技术的不同，PCI可以分为经皮冠状动脉血管内成形术(PTCA)、冠状动脉支架植入术、冠状动脉旋磨术、切割球囊成形术、冠状动脉内血栓抽吸术等。Percutaneous Coronary Intervention (PCI) refers to the treatment method of dredging the narrowed or even occluded coronary artery lumen through cardiac catheterization, so as to improve the blood perfusion of the myocardium. This treatment method has the advantages of short course of treatment, less trauma, and remarkable curative effect, and has developed rapidly in recent years. According to different implementation techniques, PCI can be divided into percutaneous coronary angioplasty (PTCA), coronary stent implantation, coronary atherectomy, cutting balloon angioplasty, and intracoronary thrombus aspiration.
如图1～2所示，目前临床使用的球囊导管的头端为套装在内管端部并与球囊直接相抵的短小的圆锥状，这种设计有利于球囊导管推力的传送，有利于球囊导管通过狭窄的病变部位或者导丝刚刚开通的慢性闭塞病变部位，然而对于迂曲血管、管腔狭窄不重的血管以及已植入支架并需要后扩张的血管来说，当球囊导管头端通过时，因为头端柔性较差，很难及时顺着血管的弯曲形状变向，头端可能抵住血管或支架，造成损伤。由于冠状动脉血管多为弯曲状，因此对于本领域的技术人员来说，如何设计一种球囊导管，使其在通过弯曲病变部位或对支架进行后扩张操作时能够及时顺着血管弯形变向，使其通过性不受到血管弯曲或支架梁的影响，以便于后扩张过程顺利进行并降低风险的发生，是迫切需要解决的问题。As shown in Figures 1 and 2, the head end of the balloon catheter currently used clinically is a short conical shape that is set on the end of the inner tube and directly against the balloon. It is beneficial for the balloon catheter to pass through the narrow lesion or the chronic occlusion lesion where the guide wire has just been opened. When the head end passes, because the head end is less flexible, it is difficult to change direction along the curved shape of the blood vessel in time, and the head end may be against the blood vessel or stent, causing damage. Since coronary arteries are mostly curved, for those skilled in the art, how to design a balloon catheter so that it can follow the curved shape of the blood vessel in time when passing through the curved lesion or performing post-expansion operations on the stent? , so that the passability is not affected by the bending of the blood vessel or the stent beam, so as to facilitate the smooth progress of the post-dilation process and reduce the risk of occurrence, it is an urgent problem to be solved.
另外，如图1～2所示，现有技术中的球囊导管头端均为细小的圆锥状，这种设计虽然有利于球囊导管通过狭窄的病变部位，或者导丝刚刚开通的慢性闭塞病变，然而对于后扩张球囊导管来说，由于其主要用于对置入血管内的支架进行后扩张，以使支架充分张开并紧贴血管内侧面，如果将后扩张球囊导管的头端设计成与预扩张球囊导管一致的圆锥状，如图2所示，在导管头端前端会有一个较小的平端面，在球囊导管沿着导丝送入支架时，所述导管头端前端的平端面往往会顶住支架梁，造成球囊导管通过困难，严重者可能会引起支架变形，引发血栓，因此对球囊导管的头端结构也需要作出改进，以使其在对支架进行后扩张操作时，其通过性不会受到支架梁的影响。In addition, as shown in Figures 1 and 2, the tip ends of balloon catheters in the prior art are all small conical shapes. Although this design is conducive to the passage of balloon catheters through narrow lesions, or chronic occlusions where the guide wire has just been opened However, for the post-dilation balloon catheter, since it is mainly used to post-expand the stent placed in the blood vessel, so that the stent can be fully expanded and close to the inner surface of the blood vessel, if the head of the post-dilation balloon catheter The end of the balloon catheter is designed to be in the same conical shape as the pre-expanded balloon catheter. As shown in Figure 2, there will be a small flat end surface at the front end of the catheter tip. When the balloon catheter is sent into the stent along the guide wire, the catheter will The flat end surface of the front end of the head tends to withstand the stent beam, making it difficult for the balloon catheter to pass through. In severe cases, it may cause deformation of the stent and cause thrombus. When the stent is post-expanded, its passability will not be affected by the stent beam.
实用新型内容Utility model content
本实用新型的目的在于提供一种头端与球囊之间设有柔性连接部的球囊导管，能够及时顺着血管弯形变向，不会受到支架网眼或支架梁的影响，便于后扩张过程顺利进行，降低风险的发生。The purpose of this utility model is to provide a balloon catheter with a flexible connection between the head end and the balloon, which can follow the bending and changing direction of the blood vessel in time, without being affected by the stent mesh or the stent beam, and facilitate the post-expansion process Go smoothly and reduce the risk of occurrence.
本实用新型的目的是通过以下技术方案来实现的：The purpose of this utility model is achieved through the following technical solutions:
一种头端与球囊之间设有柔性连接部的球囊导管，包括内管、外管、球囊和头端，内管设置于外管中，导丝由内管中穿过，球囊套设于内管的远端，且所述球囊的一端与所述外管相连，另一端与所述内管相连，所述头端后侧设有柔性连接部，所述内管的远端伸出球囊后与所述柔性连接部相连，所述柔性连接部进入血管后顺应血管形状弯曲。A balloon catheter with a flexible connection between the head end and the balloon, including an inner tube, an outer tube, a balloon and a head end, the inner tube is arranged in the outer tube, the guide wire passes through the inner tube, and the balloon The balloon is sheathed on the distal end of the inner tube, and one end of the balloon is connected to the outer tube, and the other end is connected to the inner tube. The distal end protrudes from the balloon and is connected to the flexible connection part, and the flexible connection part bends according to the shape of the blood vessel after entering the blood vessel.
所述头端呈锥状，且所述柔性连接部的外径大于、等于或小于所述头端的最大外径。The head end is tapered, and the outer diameter of the flexible connection part is greater than, equal to or smaller than the maximum outer diameter of the head end.
所述头端前侧设有凸起部，所述凸起部最大外径大于所述头端其余部分的外径，且所述头端前侧的内侧孔壁与外侧壁之间通过所述凸起部过渡衔接，所述凸起部外表面为光滑面，或者所述凸起部与头端内侧孔壁相连的一侧呈向头端后侧倾斜的面。The front side of the head end is provided with a raised portion, the maximum outer diameter of the raised portion is larger than the outer diameter of the rest of the head end, and the inner hole wall and the outer wall of the head end front side pass through the The protruding part transitions, and the outer surface of the protruding part is a smooth surface, or the side of the protruding part connected to the inner hole wall of the head end is a surface inclined toward the rear side of the head end.
所述头端前侧设有不同的凸起部，或者所述头端前端的外表面上只有一部分设置凸起部。Different protrusions are provided on the front side of the head end, or only a part of the outer surface of the front end of the head end is provided with protrusions.
所述头端的凸起部后侧设有连接杆，所述头端通过所述连接杆与所述柔性连接部相连。A connecting rod is provided on the rear side of the protrusion of the head end, and the head end is connected with the flexible connecting part through the connecting rod.
所述头端前侧设有一个逐渐收窄的过渡面，所述头端出口处的内侧孔壁与外侧壁之间通过所述过渡面衔接，所述过渡面为光滑面，或者所述过渡面与头端内侧孔壁相连的一侧呈向头端后侧倾斜的面。The front side of the head end is provided with a gradually narrowing transition surface, and the inner hole wall and the outer wall at the outlet of the head end are connected through the transition surface, and the transition surface is a smooth surface, or the transition surface The side where the surface is connected with the inner hole wall of the head end is a surface inclined to the rear side of the head end.
所述球囊的端部设有连接管，所述球囊通过所述连接管套装于内管上，所述柔性连接部和头端的直径均大于所述球囊的连接管直径。The end of the balloon is provided with a connecting tube, and the balloon is sleeved on the inner tube through the connecting tube, and the diameters of the flexible connecting part and the head end are larger than the diameter of the connecting tube of the balloon.
所述头端的后侧设置成锥状或斜面；所述柔性连接部的初始形状呈弯曲状，且所述柔性连接部进入血管后进一步顺应血管形状弯曲。The rear side of the head end is set in a cone shape or an inclined plane; the initial shape of the flexible connection part is curved, and the flexible connection part further bends according to the shape of the blood vessel after entering the blood vessel.
所述头端的径向截面呈圆形或多边形，所述柔性连接部的径向截面呈圆形或多边形。The radial section of the head end is circular or polygonal, and the radial section of the flexible connection part is circular or polygonal.
所述柔性连接部与头端为分体结构，或者为一体结构。The flexible connection part and the head end are in a separate structure, or in an integrated structure.
本实用新型的优点与积极效果为：Advantage and positive effect of the present utility model are:
1、本实用新型在头端与球囊之间设有柔性连接部，能够使头端及时顺着血管弯形变向，使其通过性能不会受到血管弯曲或支架梁的影响。1. The utility model has a flexible connection part between the head end and the balloon, which can make the head end change direction along the bending of the blood vessel in time, so that the passing performance will not be affected by the bending of the blood vessel or the stent beam.
2、本实用新型的头端设有凸起部或者过渡面，以使头端前侧不存在平端面，球囊导管在与血管支架相接触时不会受到支架梁的阻碍，可顺利滑过支架梁。2. The head end of the utility model is provided with a raised portion or a transition surface, so that there is no flat end surface on the front side of the head end, and the balloon catheter will not be hindered by the stent beam when in contact with the vascular stent, and can slide over smoothly support beam.
附图说明Description of drawings
图1为现有技术中的球囊导管远端结构示意图，Figure 1 is a schematic diagram of the structure of the distal end of a balloon catheter in the prior art,
图2为图1中的A处放大图，Figure 2 is an enlarged view of A in Figure 1,
图3为本实用新型的实施例一的结构示意图，Fig. 3 is the structural representation of embodiment one of the utility model,
图4为图3中B处放大图，Figure 4 is an enlarged view of B in Figure 3,
图5为图3中C处放大图，Figure 5 is an enlarged view at point C in Figure 3,
图6为图3中D处放大图，Figure 6 is an enlarged view at D in Figure 3,
图7为图3中E处放大图，Figure 7 is an enlarged view of E in Figure 3,
图8为本实用新型的实施例二的远端结构示意图，Fig. 8 is a schematic diagram of the remote structure of the second embodiment of the utility model,
图9为本实用新型的实施例三的远端结构示意图，Fig. 9 is a schematic diagram of the remote structure of Embodiment 3 of the present utility model,
图10为本实用新型的实施例四的远端结构示意图，Fig. 10 is a schematic diagram of the remote structure of Embodiment 4 of the present utility model,
图11为本实用新型的实施例五的远端结构示意图，Fig. 11 is a schematic diagram of the remote structure of Embodiment 5 of the present utility model,
图12为本实用新型的实施例六的远端结构示意图，Fig. 12 is a schematic view of the remote structure of Embodiment 6 of the present utility model,
图13为本实用新型的实施例七的远端结构示意图，Fig. 13 is a schematic diagram of the remote structure of Embodiment 7 of the present utility model,
图14为本实用新型的实施例八的远端结构示意图，Fig. 14 is a schematic diagram of the remote structure of the eighth embodiment of the utility model,
图15为本实用新型的实施例九的远端结构示意图，Fig. 15 is a schematic diagram of the remote structure of Embodiment 9 of the present utility model,
图16为本实用新型为通过导丝(OTW)型球囊导管时的示意图，Figure 16 is a schematic diagram of the utility model when passing through a guide wire (OTW) type balloon catheter,
图17为头端设有凸起部时的一种结构示意图，Fig. 17 is a structural schematic diagram when the head end is provided with a raised portion,
图18为头端设有凸起部时的另一种结构示意图，Fig. 18 is a schematic diagram of another structure when the head end is provided with a raised portion,
图19为头端设有凸起部时的又一种结构示意图，Fig. 19 is another structural schematic view when the head end is provided with a raised portion,
图20为头端设有凸起部时的轴向视图，Figure 20 is an axial view when the head end is provided with a raised portion,
图21为头端设有非对称凸起部时的一种结构示意图，Fig. 21 is a structural schematic diagram when an asymmetrical protrusion is provided at the head end,
图22为头端设有非对称凸起部时的另一种结构示意图，Fig. 22 is a schematic diagram of another structure when the head end is provided with an asymmetric raised part,
图23为头端设有非对称凸起部时的轴向视图，Figure 23 is an axial view when the head end is provided with an asymmetric protrusion,
图24为头端只设有部分凸起部时的一种结构示意图，Fig. 24 is a structural schematic diagram when only a part of the raised portion is provided at the head end,
图25为头端只设有部分凸起部时的另一种结构示意图，Fig. 25 is a schematic diagram of another structure when only a part of the raised portion is provided at the head end,
图26为头端凸起部的轴向截面边缘呈多边形时的示意图，Fig. 26 is a schematic diagram when the edge of the axial section of the protrusion at the head end is polygonal,
图27为头端凸起部的径向截面呈多边形时的示意图，Fig. 27 is a schematic diagram when the radial section of the protrusion at the head end is polygonal,
图28为头端壁厚加厚时的一种结构示意图，Figure 28 is a structural schematic diagram when the wall thickness of the head end is thickened,
图29为头端壁厚加厚时的另一种结构示意图，Fig. 29 is another structural schematic diagram when the wall thickness of the head end is thickened,
图30为头端壁厚加厚时的轴向视图，Figure 30 is an axial view when the wall thickness of the head end is thickened,
图31为头端壁厚加厚时的又一种结构示意图，Fig. 31 is another structural schematic diagram when the wall thickness of the head end is thickened,
图32为图31中的头端轴向视图，Figure 32 is an axial view of the head end in Figure 31,
图33为头端壁厚加厚同时后侧设有锥面的一种结构示意图，Fig. 33 is a structural schematic diagram in which the wall thickness of the head end is thickened while the rear side is provided with a tapered surface.
图34为头端壁厚加厚同时后侧设有锥面的又一种结构示意图，Fig. 34 is another structural schematic diagram in which the wall thickness of the head end is thickened while the rear side is provided with a tapered surface.
图35为头端壁厚加厚同时后侧设有锥面的另一种结构示意图，Fig. 35 is a schematic diagram of another structure in which the wall thickness of the head end is thickened while the rear side is provided with a tapered surface.
图36为头端壁厚加厚时轴向截面边缘呈多边形时的示意图，Figure 36 is a schematic diagram when the edge of the axial section is polygonal when the wall thickness of the head end is thickened,
图37为头端壁厚加厚时径向截面呈多边形时的示意图。Fig. 37 is a schematic diagram when the radial section of the head end is polygonal when the wall thickness is thickened.
其中，1为内管，11为头端，111为连接杆，12为导丝出口，13为显影环，2为外管，3为球囊，31为通液腔，32为连接管，4为柔性连接部，41为过渡斜面，5为接头，6为导管，7为应变释放管，8为平端面。Among them, 1 is the inner tube, 11 is the head end, 111 is the connecting rod, 12 is the guide wire outlet, 13 is the developing ring, 2 is the outer tube, 3 is the balloon, 31 is the liquid cavity, 32 is the connecting tube, 4 41 is a transition slope, 5 is a joint, 6 is a conduit, 7 is a strain relief tube, and 8 is a flat end surface.
具体实施方式detailed description
下面结合附图对本实用新型作进一步详述。Below in conjunction with accompanying drawing, the utility model is described in further detail.
如图3～7所示，本实用新型包括内管1、外管2、球囊3、接头5、导管6和应变释放管7，其中内管1设置于外管2中，内管1内部贯通以供导丝穿过，如图3、图5和图7所示，球囊3套设于内管1的远端(所述远端即远离操作人员的一端，也即自由端)，且所述球囊3的一端与所述外管2相连，另一端与所述内管1相连，所述球囊3内为通液腔31，如图3～4所示，设置于所述球囊3内的一段内管1外侧设有多个显影环13，通过相应的仪器能够显示显影环13的位置，从而帮助操作人员了解球囊的位置，如图6所示，在外管2的近端(所述近端即靠近操作人员的一端)内设有导管6，且所述导管6设置于内管1外侧，如图3所示，所述导管6的近端与接头5相连，在所述接头5上设有应变释放管7，且所述应变释放管7扣装于所述接头5的远端，所述应变释放管7用于避免应力集中，以提高球囊导管的使用寿命。As shown in Figures 3 to 7, the utility model includes an inner tube 1, an outer tube 2, a balloon 3, a joint 5, a catheter 6 and a strain relief tube 7, wherein the inner tube 1 is arranged in the outer tube 2, and the inside of the inner tube 1 Through for the guide wire to pass through, as shown in Figure 3, Figure 5 and Figure 7, the balloon 3 is sleeved on the distal end of the inner tube 1 (the distal end is the end away from the operator, that is, the free end), And one end of the balloon 3 is connected to the outer tube 2, and the other end is connected to the inner tube 1. The inside of the balloon 3 is a liquid cavity 31, as shown in FIGS. A section of the inner tube 1 in the balloon 3 is provided with a plurality of developing rings 13 on the outside, and the positions of the developing rings 13 can be displayed through corresponding instruments, thereby helping the operator understand the position of the balloon. As shown in FIG. The proximal end (the proximal end is the end close to the operator) is provided with a catheter 6, and the catheter 6 is arranged on the outside of the inner tube 1, as shown in Figure 3, the proximal end of the catheter 6 is connected to the joint 5, A strain relief tube 7 is provided on the joint 5, and the strain relief tube 7 is buckled on the distal end of the joint 5, and the strain relief tube 7 is used to avoid stress concentration to improve the use of the balloon catheter life.
所述球囊3采用加压加热吹塑成型，将内径为0.3～1.5mm、外径为0.6～2.0mm、长度为400～600mm的尼龙管材，在压力为300～600PSI、160～220摄氏度的条件下吹制，得到直径为2.0～5.0mm、长为5.0～30.0mm的圆筒即为球囊3主体，如图5和图7所示，在所述球囊3两端分别设置有连接管32，所述连接管32的外径为0.60～1.02mm，长度为1.0～10.0mm，球囊3通过两端的连接管32分别套装于所述内管1和外管2上，从而实现与内管1和外管2相连，球囊3与内管1之间形成通液腔31，所述通液腔31在通入显影液之后能够胀大，从而将支架撑开。The balloon 3 is molded by pressurized heating and blow molding. A nylon tube with an inner diameter of 0.3-1.5 mm, an outer diameter of 0.6-2.0 mm, and a length of 400-600 mm is heated at a temperature of 300-600 PSI and 160-220 degrees Celsius. Blowing under the conditions to obtain a cylinder with a diameter of 2.0 to 5.0 mm and a length of 5.0 to 30.0 mm is the main body of the balloon 3, as shown in Figure 5 and Figure 7, and the two ends of the balloon 3 are respectively provided with connecting Tube 32, the outer diameter of the connecting tube 32 is 0.60-1.02 mm, and the length is 1.0-10.0 mm. The balloon 3 is respectively sleeved on the inner tube 1 and the outer tube 2 through the connecting tubes 32 at both ends, so as to realize the connection with The inner tube 1 is connected to the outer tube 2 , and a liquid-through cavity 31 is formed between the balloon 3 and the inner tube 1 , and the liquid-through cavity 31 can expand after being injected with developing solution, thereby propagating the stent.
所述外管2采用尼龙、聚乙烯、聚丙烯或嵌段聚酰胺材质，在挤出温度200～280摄氏度，冷却温度15～40摄氏度的条件下挤出长为250～1600mm、外径为0.76～0.86mm、厚度为0.04～0.14mm的管材即得到所述外管2。The outer tube 2 is made of nylon, polyethylene, polypropylene or block polyamide, with an extrusion length of 250-1600mm and an outer diameter of 0.76mm at an extrusion temperature of 200-280 degrees Celsius and a cooling temperature of 15-40 degrees Celsius. The outer tube 2 is obtained from a pipe material with a thickness of 0.86 mm and a thickness of 0.04 to 0.14 mm.
所述内管1采用尼龙、聚乙烯、聚丙烯或嵌段聚酰胺材质，与外管2在相同的条件下制得，长度为250～1600mm，外径为0.50～0.61mm。The inner tube 1 is made of nylon, polyethylene, polypropylene or block polyamide, and is manufactured under the same conditions as the outer tube 2, with a length of 250-1600 mm and an outer diameter of 0.50-0.61 mm.
如图7所示，所述内管1的远端伸出球囊3后通过柔性连接部4与头端11相连，当球囊导管进入弯曲血管时，所述柔性连接部4在外力作用下会顺应血管弯形弯曲，从而有效避免头端11顶住支架梁，保证导管通过，所述柔性连接部4采用尼龙、聚乙烯、聚丙烯或嵌段聚酰胺材质制成。As shown in Fig. 7, the distal end of the inner tube 1 protrudes from the balloon 3 and is connected to the head end 11 through a flexible connection part 4. When the balloon catheter enters a curved blood vessel, the flexible connection part 4 is under the action of external force It will conform to the bend of the blood vessel, so as to effectively prevent the head end 11 from resisting the stent beam and ensure the passage of the catheter. The flexible connecting part 4 is made of nylon, polyethylene, polypropylene or block polyamide.
所述柔性连接部4与头端11可设计成分体结构，也可以设计成一体结构。当柔性连接部4与头端11为分体结构时，所述柔性连接部4可采用尼龙、聚乙烯、聚丙烯、嵌段聚酰胺或聚氨酯材质并通过挤出方式成型，在挤出温度200～280摄氏度，冷却温度15～40摄氏度的条件下挤出管材，长0～20mm，外径为0.50～2mm，厚度为0.07～0.82mm。当柔性连接部4与头端11为一体结构时，所述柔性连接部4和头端11采用尼龙、聚乙烯、聚丙烯、嵌段聚酰胺或聚氨酯材质，并利用注塑的方法在相应形状的模具内注塑一体成型。The flexible connecting part 4 and the head end 11 can be designed as a separate structure, or can be designed as an integral structure. When the flexible connection part 4 and the head end 11 are of a split structure, the flexible connection part 4 can be made of nylon, polyethylene, polypropylene, block polyamide or polyurethane and formed by extrusion. ~ 280 degrees Celsius, cooling temperature 15 ~ 40 degrees Celsius to extrude pipes, length 0 ~ 20mm, outer diameter 0.50 ~ 2mm, thickness 0.07 ~ 0.82mm. When the flexible connection part 4 and the head end 11 are in one structure, the flexible connection part 4 and the head end 11 are made of nylon, polyethylene, polypropylene, block polyamide or polyurethane, and are molded in corresponding shapes by injection molding. Injection molding in one mold.
所述头端11根据需要可设计成锥状，另外如图1～2所示，如果将后扩张球囊导管也设计成锥状，由于头端11前端会有一个较小的平端面8，在球囊导管沿着导丝送入支架时，所述平端面8往往会顶住支架梁而使导管无法通过，为了解决这个问题，所述头端11结构需作出改进。The head end 11 can be designed into a conical shape according to needs. In addition, as shown in FIGS. When the balloon catheter is fed into the stent along the guide wire, the flat end surface 8 will often withstand the stent beam and the catheter cannot pass through. In order to solve this problem, the structure of the head end 11 needs to be improved.
实施例1Example 1
如图3所示，本实施例为快速交换型球囊导管，在导管中部设有导丝出口12。As shown in FIG. 3 , this embodiment is a rapid-exchange balloon catheter, and a guide wire outlet 12 is provided in the middle of the catheter.
如图7所示，本实施例中采用呈锥状的头端11，且所述头端11与柔性连接部4为分体结构。所述柔性连接部4一端套装在内管1上，所述柔性连接部4的另一端通过止口配合与所述头端11的后侧连接，所述柔性连接部4的直径与球囊3的连接管32直径相同，同时所述柔性连接部4的直径与所述头端11外锥面的最大直径也相同。当球囊导管进入弯曲血管时，所述柔性连接部4在外力作用下易产生顺应血管弯形的弯曲，从而保证导管通过。As shown in FIG. 7 , in this embodiment, a tapered head end 11 is adopted, and the head end 11 and the flexible connection part 4 are in a separate structure. One end of the flexible connection part 4 is sleeved on the inner tube 1, and the other end of the flexible connection part 4 is connected to the rear side of the head end 11 through a seam fit. The diameter of the flexible connection part 4 is the same as that of the balloon 3 The diameter of the connecting pipe 32 is the same, and the diameter of the flexible connecting part 4 is also the same as the maximum diameter of the outer tapered surface of the head end 11. When the balloon catheter enters a curved blood vessel, the flexible connection part 4 is likely to bend to conform to the shape of the blood vessel under the action of an external force, thereby ensuring the passage of the catheter.
实施例2Example 2
如图8所示，本实施例与实施例1不同之处在于所述头端11与柔性连接部4为一体成型结构，当球囊导管进入弯曲血管时，所述柔性连接部4以及头端11在外力作用下均易产生顺应血管弯形的弯曲，从而保证导管通过。As shown in Figure 8, the difference between this embodiment and Embodiment 1 is that the head end 11 and the flexible connection part 4 are integrally formed. When the balloon catheter enters a curved blood vessel, the flexible connection part 4 and the head end 11 Under the action of external force, it is easy to produce a bend conforming to the shape of the blood vessel, so as to ensure the passage of the catheter.
实施例3Example 3
如图9所示，本实施例与实施例1不同之处在于所述头端11外锥面的最大外径小于所述柔性连接部4的直径，并且在所述柔性连接部4与头端11相连的一端设有过渡斜面41，所述柔性连接部4的直径与球囊3的连接管32直径相同。As shown in Figure 9, the difference between this embodiment and Embodiment 1 is that the maximum outer diameter of the outer tapered surface of the head end 11 is smaller than the diameter of the flexible connection part 4, and between the flexible connection part 4 and the head end The end connected to 11 is provided with a transition slope 41 , and the diameter of the flexible connecting part 4 is the same as that of the connecting tube 32 of the balloon 3 .
实施例4Example 4
如图10所示，本实施例与实施例1不同之处在于所述头端11外锥面的最大直径大于所述柔性连接部4的直径，所述柔性连接部4的直径与球囊3的连接管32直径相同。As shown in Figure 10, the difference between this embodiment and Embodiment 1 is that the maximum diameter of the outer tapered surface of the head end 11 is larger than the diameter of the flexible connection part 4, and the diameter of the flexible connection part 4 is the same as that of the balloon 3. The connecting pipes 32 have the same diameter.
实施例5Example 5
如图3所示，本实施例为快速交换型球囊导管，在导管中部设有导丝出口12。As shown in FIG. 3 , this embodiment is a rapid-exchange balloon catheter, and a guide wire outlet 12 is provided in the middle of the catheter.
如图11所示，本实施例采用设有凸起部的头端11，且所述头端11与柔性连接部4为分体结构。所述头端11包括前侧的凸起部和后侧的连接杆111，所述柔性连接部4一端套装在内管1上，另一端通过止口配合与所述头端11后侧的连接杆111相连，所述柔性连接部4的直径、所述球囊3的连接管32直径以及所述头端11的连接杆111直径均相同，所述头端11前侧的凸起部最大外径大于所述柔性连接部4的直径以及头端11其他部分的直径，并且所述头端11的凸起部的最大高度大于支架与血管内壁的距离，以使导管顺利滑过支架梁。As shown in FIG. 11 , this embodiment adopts a head end 11 provided with a raised portion, and the head end 11 and the flexible connecting portion 4 are in a separate structure. The head end 11 includes a protrusion on the front side and a connecting rod 111 on the rear side. One end of the flexible connection part 4 is sleeved on the inner tube 1, and the other end is connected to the rear side of the head end 11 through a spigot fit. The diameter of the flexible connecting part 4, the diameter of the connecting tube 32 of the balloon 3 and the diameter of the connecting rod 111 of the head end 11 are all the same, and the protrusion on the front side of the head end 11 has the largest outer diameter The diameter is greater than the diameter of the flexible connecting part 4 and the diameter of other parts of the head end 11, and the maximum height of the protrusion of the head end 11 is greater than the distance between the stent and the inner wall of the blood vessel, so that the catheter can slide through the stent beam smoothly.
如图11所示，所述凸起部设置于头端11前侧，且所述头端11前侧的内侧孔壁和外侧壁之间通过所述凸起部衔接过渡，所述凸起部外表面可以设置为光滑面，这样便不存在抵住支架梁的平端面8，从而使导管顺利滑过支架梁，或者如图26所示，所述凸起部外表面包括多个平面，任意相邻两个平面之间的夹角均为钝角，这样便形成近似弧面的形状，并且凸起部外表面与头端11内侧孔壁相连的平面向头端11后侧倾斜，这样便不存在能够抵住支架梁的平端面8，也可以起到顺利滑过支架梁的作用，加上所述柔性连接部4在外力作用下易产生顺应血管弯形的弯曲，从而进一步保证导管顺利通过。如图19所示，由于导丝由头端11内孔穿过，所述头端11的出口内侧也可以设置成向外侧翻转并与头端11外侧的凸起部光滑衔接的弧面，从而使头端11出口与导丝接触时更加平滑。所述凸起部外表面也可以设置成光滑面与平面衔接的结构，只要前侧与头端11的内孔壁相连的面不形成能够抵住支架梁的平端面8即可。As shown in Figure 11, the raised portion is arranged on the front side of the head end 11, and the inner hole wall and the outer wall of the front side of the head end 11 are connected and transitioned through the raised portion, and the raised portion The outer surface can be set as a smooth surface, so that there is no flat end surface 8 against the support beam, so that the catheter can slide smoothly over the support beam, or as shown in Figure 26, the outer surface of the raised part includes multiple planes, any The included angles between two adjacent planes are obtuse angles, so that an approximate arc surface is formed, and the plane where the outer surface of the protrusion is connected to the inner hole wall of the head end 11 is inclined to the rear side of the head end 11, so that it does not There is a flat end surface 8 that can resist the stent beam, and can also play the role of sliding over the stent beam smoothly. In addition, the flexible connection part 4 is easy to produce a bend that conforms to the shape of the blood vessel under the action of an external force, thereby further ensuring the smooth passage of the catheter . As shown in Figure 19, since the guide wire passes through the inner hole of the head end 11, the inner side of the outlet of the head end 11 can also be set as an arc surface that turns outward and smoothly connects with the protrusion on the outer side of the head end 11, so that The outlet of the head end 11 is smoother when in contact with the guide wire. The outer surface of the raised portion can also be configured as a smooth surface connected to a plane, as long as the front side connected to the inner hole wall of the head end 11 does not form a flat end surface 8 capable of resisting the support beam.
如图17～20所示，所述头端11上的凸起部可以为对称结构绕所述头端11轴线旋转而成的旋转体，也即所述凸起部的任一轴向截面均为对称结构，只不过所述凸起部轴向截面的外边缘根据需要设置成不同弧度，或者所述头端11上的凸起部也可以设计成非对称形式，比如图21～23所示，所述头端11两侧分别设有外表面弧度不同的凸起部，或者如图24～25所示，所述头端11前侧外表面上只有一部分设置凸起部，其余部分为锥度指向头端11前侧的锥面，或者是向头端11内侧倾斜的斜面，所述头端11和柔性连接部4径向截面可以设计成圆形，或者如图27所示，沿着所述头端11的轴向看去，所述头端11和柔性连接部4径向截面也可以设计成呈近似圆形的多边形。As shown in Figures 17-20, the protrusion on the head end 11 can be a rotating body formed by rotating around the axis of the head end 11 with a symmetrical structure, that is, any axial section of the protrusion is It is a symmetrical structure, except that the outer edge of the axial section of the protrusion is set in different radians according to needs, or the protrusion on the head end 11 can also be designed in an asymmetric form, such as shown in Figures 21-23 , the two sides of the head end 11 are respectively provided with protrusions with different outer surface radians, or as shown in Figures 24-25, only a part of the outer surface of the front side of the head end 11 is provided with protrusions, and the rest is tapered The tapered surface pointing to the front side of the head end 11, or the inclined surface inclined to the inside of the head end 11, the radial section of the head end 11 and the flexible connecting part 4 can be designed as a circle, or as shown in Figure 27, along the Seen from the axial direction of the head end 11 , the radial cross section of the head end 11 and the flexible connecting part 4 can also be designed as a polygonal shape that is approximately circular.
实施例6Example 6
如图12所示，本实施例与实施例5的不同之处在于：所述头端11省去了呈管状的连接杆111，头端11的凸起部直接与所述柔性连接部4相连。As shown in FIG. 12 , the difference between this embodiment and Embodiment 5 is that: the head end 11 omits the tubular connecting rod 111 , and the convex part of the head end 11 is directly connected with the flexible connection part 4 .
实施例7Example 7
如图13所示，本实施例与实施例5的不同之处在于：所述头端11与柔性连接部4为一体结构，当球囊导管进入弯曲血管时，所述柔性连接部4以及头端11在外力作用下均易产生顺应血管弯形的弯曲，从而保证导管通过。As shown in Figure 13, the difference between this embodiment and Embodiment 5 is that: the head end 11 and the flexible connection part 4 are integrally structured, and when the balloon catheter enters a curved blood vessel, the flexible connection part 4 and the head end Under the action of external force, the end 11 is easy to produce a bend conforming to the shape of the blood vessel, so as to ensure the passage of the catheter.
实施例8Example 8
如图3所示，本实施例为快速交换型的球囊导管，在导管中部设有导丝出口12。As shown in FIG. 3 , this embodiment is a quick-exchange balloon catheter, and a guide wire outlet 12 is provided in the middle of the catheter.
如图14所示，本实施例中采用壁厚加厚的头端11，且所述头端11与柔性连接部4为分体结构。所述柔性连接部4一端套装在内管1上，另一端通过止口配合与所述头端11后侧相连，所述柔性连接部4的直径与所述头端11的直径相同，并且均大于所述球囊3的连接管32直径，并且所述头端11的壁厚大于支架与血管内壁的距离，以使导管顺利滑过支架梁。As shown in FIG. 14 , in this embodiment, a thickened head end 11 is adopted, and the head end 11 and the flexible connecting part 4 are in a separate structure. One end of the flexible connection part 4 is sleeved on the inner tube 1, and the other end is connected to the rear side of the head end 11 through a seam fit. The diameter of the flexible connection part 4 is the same as that of the head end 11, and both The diameter of the connecting tube 32 is larger than that of the balloon 3, and the wall thickness of the head end 11 is larger than the distance between the stent and the inner wall of the blood vessel, so that the catheter can smoothly slide through the stent beam.
在所述头端11前侧设有一个逐渐收窄的过渡面，所述头端11前侧的内侧孔壁与外侧壁之间通过所述过渡面衔接，如图14所示，所述过渡面可以为直接与头端11的内孔壁相连的光滑面，这样便不存在会抵住支架梁的平端面8，导管可以顺利滑过支架梁，或者如图36所示，所述过渡面包括多个平面，任意相邻两平面之间的夹角为钝角，这样便形成近似弧面的形状，并且与头端11内侧孔壁相连的平面向头端11后侧倾斜，这样便不存在能够抵住支架梁的平端面8，也可以起到顺利滑过支架梁的作用，加上所述柔性连接部4在外力作用下易产生顺应血管弯形的弯曲，从而进一步保证导管顺利通过。所述过渡面也可以设置成光滑面与平面衔接的结构，只要前侧与头端11的内孔壁相连的面不形成能够抵住支架梁的平端面8即可。A gradually narrowing transition surface is provided on the front side of the head end 11, and the inner hole wall and the outer wall of the front side of the head end 11 are connected through the transition surface. As shown in FIG. 14, the transition The surface can be a smooth surface directly connected to the inner hole wall of the head end 11, so that there is no flat end surface 8 that will be against the support beam, and the catheter can slide smoothly over the support beam, or as shown in Figure 36, the transition surface Including multiple planes, the angle between any two adjacent planes is an obtuse angle, which forms an approximate arc surface shape, and the plane connected to the inner hole wall of the head end 11 is inclined to the rear side of the head end 11, so that there is no Being able to resist the flat end surface 8 of the stent beam can also play the role of sliding over the stent beam smoothly, and the flexible connection part 4 is easy to produce a bend conforming to the shape of the blood vessel under the action of external force, thereby further ensuring the smooth passage of the catheter. The transition surface can also be configured as a smooth surface connected to a plane, as long as the front side connected to the inner hole wall of the head end 11 does not form a flat end surface 8 that can resist the support beam.
如图14及图28所示，所述头端11前侧的光滑面设置于头端11外侧且可以根据实际需要设置成弧度不同的光滑面。如图29所示，由于导丝由头端11内孔穿过，所述头端11的出口内侧也可以设置成向外侧翻转并与头端11外侧的过渡面光滑衔接的弧面，从而使头端11出口与导丝接触时更加平滑。如图30所示，所述头端11可以为对称结构绕所述头端11轴线旋转而成的旋转体，即沿着所述头端11的轴向看去，所述头端11的径向截面呈圆形，或者如图37所示，沿着所述头端11的轴向看去，所述头端11和柔性连接部4径向截面也可以设计成呈近似圆形的多边形。如图31～32所示，所述头端11前侧外表面只有一部分设置成过渡面，其余部分设置成锥面或斜面，如图33～35所示，所述头端11的后侧可进一步设计成锥度指向头端11后侧的锥状或斜面。As shown in FIG. 14 and FIG. 28 , the smooth surface on the front side of the head end 11 is set on the outside of the head end 11 and can be set as a smooth surface with different radians according to actual needs. As shown in Figure 29, since the guide wire passes through the inner hole of the head end 11, the inner side of the outlet of the head end 11 can also be set as an arc surface that turns outward and smoothly connects with the transition surface on the outside of the head end 11, so that the head end The outlet of end 11 is smoother when in contact with the guide wire. As shown in Figure 30, the head end 11 can be a rotating body formed by rotating around the axis of the head end 11 with a symmetrical structure, that is, viewed along the axial direction of the head end 11, the diameter of the head end 11 The cross-section is circular, or as shown in FIG. 37 , viewed along the axial direction of the head end 11 , the radial cross-section of the head end 11 and the flexible connecting part 4 can also be designed as a polygonal shape that is approximately circular. As shown in Figures 31-32, only a part of the outer surface of the front side of the head end 11 is set as a transition surface, and the rest is set as a conical surface or an inclined surface. As shown in Figures 33-35, the rear side of the head end 11 can be It is further designed into a conical shape or an inclined plane whose taper points to the rear side of the head end 11 .
实施例9Example 9
如图16所示，本实施例为通过导丝(OTW)型球囊导管，导丝接口12设置于接头5上。As shown in FIG. 16 , this embodiment is an over-the-wire (OTW) type balloon catheter, and the guide wire interface 12 is arranged on the joint 5 .
如图15所示，本实施例中的头端11与柔性连接部4为分体结构，且所述柔性连接部4的初始形状呈弯曲状，所述柔性连接部4一端套装在内管1上，另一端通过止口配合与所述头端11相连，当球囊导管进入弯曲血管时，所述柔性连接部4在外力作用下会进一步顺应血管弯形的弯曲，从而保证导管通过。As shown in Figure 15, the head end 11 and the flexible connecting part 4 in this embodiment are of a separate structure, and the initial shape of the flexible connecting part 4 is curved, and one end of the flexible connecting part 4 is sleeved on the inner tube 1 The other end is connected to the head end 11 through a spigot fit. When the balloon catheter enters a curved blood vessel, the flexible connection part 4 will further conform to the curved shape of the blood vessel under the action of external force, thereby ensuring the passage of the catheter.
所述柔性连接部4可以呈光滑弧状弯曲，也可以呈角状折弯。The flexible connecting portion 4 can be curved in a smooth arc, or bent in an angle.
所述柔性连接部4与头端11可设计成分体结构，也可以设计成一体结构，所述头端11也可采用其他实施例中的结构。The flexible connection part 4 and the head end 11 can be designed as a separate structure, or can be designed as an integral structure, and the head end 11 can also adopt the structure in other embodiments.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201620486317.5UCN205867280U (en) | 2016-05-25 | 2016-05-25 | Be equipped with sacculus pipe of flexonics portion between head end and sacculus |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201620486317.5UCN205867280U (en) | 2016-05-25 | 2016-05-25 | Be equipped with sacculus pipe of flexonics portion between head end and sacculus |
| Publication Number | Publication Date |
|---|---|
| CN205867280Utrue CN205867280U (en) | 2017-01-11 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201620486317.5UActiveCN205867280U (en) | 2016-05-25 | 2016-05-25 | Be equipped with sacculus pipe of flexonics portion between head end and sacculus |
| Country | Link |
|---|---|
| CN (1) | CN205867280U (en) |
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|---|---|---|---|---|
| WO2017202073A1 (en)* | 2016-05-25 | 2017-11-30 | 孙英贤 | Balloon catheter employing non-tapered tip |
| WO2017202042A1 (en)* | 2016-05-25 | 2017-11-30 | 孙英贤 | Balloon catheter provided with flexible connecting part between tip and balloon |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2017202073A1 (en)* | 2016-05-25 | 2017-11-30 | 孙英贤 | Balloon catheter employing non-tapered tip |
| WO2017202042A1 (en)* | 2016-05-25 | 2017-11-30 | 孙英贤 | Balloon catheter provided with flexible connecting part between tip and balloon |
| CN107432980A (en)* | 2016-05-25 | 2017-12-05 | 孙英贤 | The foley's tube of flexible joint is provided between a kind of head end and sacculus |
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| Date | Code | Title | Description |
|---|---|---|---|
| GR01 | Patent grant | ||
| TR01 | Transfer of patent right | Effective date of registration:20230731 Address after:110000 No. 155 North Nanjing street, Heping District, Liaoning, Shenyang Patentee after:THE FIRST HOSPITAL OF CHINA MEDICIAL University Address before:110000 5-4-2, No.8, Longquan Road, Heping District, Shenyang City, Liaoning Province Patentee before:Sun Yingxian | |
| TR01 | Transfer of patent right |