WO2017202073A1 - 一种采用非锥状头端的球囊导管 - Google Patents

一种采用非锥状头端的球囊导管 Download PDF

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Publication number
WO2017202073A1
WO2017202073A1 PCT/CN2017/073853 CN2017073853W WO2017202073A1 WO 2017202073 A1 WO2017202073 A1 WO 2017202073A1 CN 2017073853 W CN2017073853 W CN 2017073853W WO 2017202073 A1 WO2017202073 A1 WO 2017202073A1
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Prior art keywords
head end
balloon
wall
inner tube
balloon catheter
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PCT/CN2017/073853
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English (en)
French (fr)
Inventor
孙英贤
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孙英贤
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Publication date
Application filed by 孙英贤 filed Critical 孙英贤
Priority to JP2018600149U priority Critical patent/JP3221414U/ja
Publication of WO2017202073A1 publication Critical patent/WO2017202073A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • the utility model relates to the technical field of medical instruments, in particular to a balloon catheter using a non-conical head end.
  • PCI Percutaneous Coronary Intervention
  • the head end of the currently used balloon catheter has a conical shape with a thin wall thickness. This design is beneficial to the transmission of the balloon catheter thrust and also facilitates the passage of the balloon catheter through the narrow.
  • the posterior dilatation balloon catheter it is mainly used for post-expansion of the stent placed in the blood vessel so that the stent is fully opened and close to the blood vessel.
  • the head end of the posterior dilatation balloon catheter is designed to be conical, as shown in Fig.
  • a small flat end surface is formed on the front side of the catheter tip end, when the balloon catheter is fed into the stent along the guide wire.
  • the flat end face on the front side of the catheter tip end tends to withstand the stent beam, which makes the balloon catheter difficult to pass. In severe cases, the stent may be deformed and cause a thrombus. Therefore, the head end structure of the balloon catheter needs to be improved so that it When the stent is post-expanded, its passability is not affected by the stent beam.
  • the purpose of the utility model is to provide a balloon catheter with a non-tapered head end, which is not affected by the stent mesh or the stent beam during the post-expansion operation of the stent, facilitating the smooth progress of the post-expansion process and reducing the risk occurrence. .
  • a balloon catheter adopting a non-tapered head end comprising an inner tube, an outer tube, a balloon and a head end, the inner tube is disposed in the outer tube, the guide wire is passed through the inner tube, and the balloon is sleeved on the inner tube a distal end, and one end of the balloon is connected to the outer tube, and the other end is connected to the inner tube, and the distal end of the inner tube is extended from the balloon and connected to the head end, and the body thickness of the head end is thick
  • the outer diameter of the head end maximum wall thickness is greater than or equal to the outer diameter of other portions of the head end body.
  • the front end of the head end is provided with a gradually narrowing transition surface, and the inner hole wall and the outer side wall at the outlet of the head end are connected by the transition surface, the transition surface is a smooth surface, or the transition
  • the side of the face that is connected to the inner wall of the head end is a face that is inclined toward the rear side of the head end.
  • the transition surface When the transition surface is a non-smooth surface, the transition surface includes a plurality of planes, an angle between any adjacent two planes is an obtuse angle, and a side of the transition surface connected to the inner wall of the head end is oriented The plane at the back of the head end is inclined.
  • the front end of the head end is provided with a convex portion, and the inner hole wall and the outer side wall at the outlet of the head end are connected by the convex portion, and the maximum outer diameter of the convex portion is larger than the rest of the head end
  • the outer diameter of the convex portion is a smooth surface, or the side of the convex portion connected to the inner wall of the head end is inclined toward the rear side of the head end.
  • the convex portion When the convex portion is a non-smooth surface, the convex portion includes a plurality of planes, an angle between any adjacent two planes is an obtuse angle, and the side of the convex portion connected to the inner wall of the head end is A plane that is inclined toward the back side of the head end.
  • the front end of the head end is provided with a different convex portion, or only a part of the outer surface of the front end of the front end is provided with a convex portion.
  • the rear side of the head end is provided in a tapered shape or a sloped surface.
  • the radial end of the head end is circular or polygonal.
  • a flexible connecting portion is disposed between the inner tube and the head end, and the flexible connecting portion bends in conformity with the blood vessel after entering the blood vessel.
  • the body thickness of the head end of the utility model is not gradually thinned, and the maximum wall thickness is greater than the distance between the bracket and the inner wall of the blood vessel, or a convex portion is provided at the head end, and the maximum outer diameter of the convex portion is larger than the stent and the blood vessel.
  • the distance of the inner wall so that the catheter can smoothly slide over the stent beam during the post-expansion operation.
  • the front side of the head end of the present invention is provided with a gradually narrowing transition surface, the transition surface is a smooth surface, or the side of the transition surface connected to the inner wall of the head end is inclined toward the rear side of the head end, This will not form a flat end surface against the bracket beam, ensuring the smooth passage of the duct.
  • the head end of the utility model is provided with a convex portion
  • the inner wall of the head end and the outer side wall are connected by the convex portion
  • the outer surface of the convex portion is a smooth surface, or the convex portion
  • the side connected to the inner wall of the head end is inclined to the rear side of the head end, so that the flat end surface against the bracket beam is not formed, and the passage of the duct is ensured.
  • FIG. 1 is a schematic view showing the distal structure of a balloon catheter in the prior art
  • FIG. 2 is an enlarged view of A in Figure 1
  • FIG. 3 is a schematic structural view of a first embodiment of the present invention
  • Figure 4 is an enlarged view of B in Figure 3
  • FIG. 5 is an enlarged view of the portion C in Figure 3,
  • Figure 6 is an enlarged view of the portion D in Figure 3,
  • FIG. 7 is an enlarged view of E in Figure 3,
  • FIG. 8 is a schematic view of the present invention when passing through a guide wire (OTW) type balloon catheter,
  • OGW guide wire
  • Figure 9 is a schematic view showing a structure when the head end is provided with a convex portion.
  • Figure 10 is a schematic view showing another structure when the head end is provided with a convex portion.
  • Figure 11 is a schematic view showing another structure when the head end is provided with a convex portion.
  • Figure 12 is an axial view of the head end with a raised portion
  • Figure 13 is a schematic structural view of the head end provided with an asymmetric convex portion
  • Figure 14 is a schematic view showing another structure when the head end is provided with an asymmetric convex portion.
  • Figure 15 is an axial view of the head end with an asymmetric projection.
  • Figure 16 is a schematic view showing a structure when only a part of the boss is provided at the head end.
  • Figure 17 is a schematic view showing another structure when only a part of the boss is provided at the head end.
  • Figure 18 is a schematic view showing a state in which the axial section of the head end projection is polygonal.
  • Figure 19 is a schematic view showing a radial section of the head end boss being polygonal.
  • Figure 20 is a schematic view showing a structure when the wall thickness of the head end is thickened.
  • Figure 21 is a schematic view showing another structure when the thickness of the head end is thickened.
  • Figure 22 is an axial view of the head end wall thickened
  • Figure 23 is a schematic view showing another structure when the thickness of the head end is thickened.
  • Figure 24 is an axial end view of the head end of Figure 23
  • Figure 25 is a schematic view showing a structure in which the thickness of the head end is thickened and the back side is provided with a tapered surface.
  • Figure 26 is a schematic view showing another structure in which the thickness of the head end is thickened and the back side is provided with a tapered surface.
  • Figure 27 is a schematic view showing another structure in which the thickness of the head end is thickened and the back side is provided with a tapered surface.
  • Figure 28 is a schematic view showing a state in which the axial section edge is polygonal when the head end wall thickness is thick.
  • Figure 29 is a schematic view showing a radial cross section when the thickness of the head end is thickened
  • Figure 30 is a schematic view showing a flexible connecting portion between the inner tube and the tip end.
  • 1 is the inner tube
  • 11 is the head end
  • 12 is the guide wire outlet
  • 13 is the developing ring
  • 2 is the outer tube
  • 3 is the balloon
  • 31 is the liquid-passing cavity
  • 32 is the connecting tube
  • 4 is the flat end face
  • 6 is the conduit
  • 7 is the strain relief tube
  • 8 is the flexible joint.
  • a flat end surface 4 is formed between the outer side surface and the front end section of the catheter head end in the prior art.
  • the utility model comprises an inner tube 1, an outer tube 2, a balloon 3, a joint 5, a duct 6 and a strain relief tube 7, wherein the inner tube 1 is disposed in the outer tube 2, and the inner tube 1 is inside
  • the balloon 3 is sleeved at the distal end of the inner tube 1, and one end of the balloon 3 Connected to the outer tube 2, the other end is connected to the inner tube 1, and the inside of the balloon 3 is a liquid-passing chamber 31.
  • a section of the inner tube is disposed in the balloon 3.
  • a catheter 6 is arranged in the proximal end of the outer tube 2
  • the duct 6 is disposed outside the inner tube 1
  • the proximal end of the outer tube 2 is connected to the joint 5
  • a strain relief tube 7 is disposed between the proximal end of the outer tube 2 and the joint 5
  • a strain relief tube 7 is fastened to the joint 5 for preventing stress concentration to improve the service life of the balloon catheter.
  • the balloon 3 is formed by pressure heating and blow molding, and the nylon pipe having an inner diameter of 0.3 to 1.5 mm, an outer diameter of 0.6 to 2.0 mm, and a length of 400 to 600 mm is at a pressure of 300 to 600 PSI and 160 to 220 degrees Celsius. Under the condition of blowing, a cylinder having a diameter of 2.0 to 5.0 mm and a length of 5.0 to 30.0 mm is obtained as a main body of the balloon 3, and a connecting tube 32 is disposed at each end of the balloon 3, and the connecting tube 32 is provided.
  • the outer diameter is 0.60-1.02 mm, and the length is 1.0-5.0 mm.
  • the balloon 3 is respectively placed on the inner tube 1 and the outer tube 2 through the connecting tubes 32 at both ends, thereby being connected to the inner tube 1 and the outer tube 2,
  • a liquid passage chamber 31 is formed between the balloon 3 and the inner tube 1, and the liquid passage chamber 31 can be swollen after the developer is introduced to expand the holder.
  • the outer tube 2 is made of nylon, polyethylene, polypropylene or block polyamide, and has an extrusion temperature of 250 to 1600 mm and an outer diameter of 0.76 at an extrusion temperature of 200 to 280 degrees Celsius and a cooling temperature of 15 to 40 degrees Celsius.
  • the outer tube 2 is obtained by a pipe having a thickness of 0.86 mm and a thickness of 0.04 to 0.14 mm.
  • the inner tube 1 is made of nylon, polyethylene, polypropylene or block polyamide, and is made under the same conditions as the outer tube 2, and has a length of 250 to 1600 mm and an outer diameter of 0.50 to 0.61 mm.
  • the distal end of the inner tube 1 is extended from the balloon 3 and is connected to the head end 11.
  • the wall thickness of the body of the head end 11 is not gradually thinned.
  • the maximum wall thickness of the head end 11 is greater than the distance between the bracket and the inner wall of the blood vessel, and the front end of the head end 11 does not have a flat end surface 4 that abuts against the bracket beam, so that the duct smoothly slides over the bracket beam, or is convex at the head end 11
  • the maximum outer diameter of the protrusion is greater than the distance between the bracket and the inner wall of the blood vessel, and the front end of the head end 11 does not have a flat end surface 4 that abuts against the bracket beam, so that the catheter smoothly slides over the bracket beam, and the inner tube is
  • a flexible connecting portion 8 can also be provided between the head ends.
  • this embodiment is a quick-exchange type balloon catheter, and a guide wire outlet 12 is provided in the middle of the catheter.
  • a head end 11 having a thick wall thickness is used, and the head end 11 is fitted to the end of the inner tube 1 and abuts against the connecting tube 32 of the balloon 3, the head end 11
  • the diameter of the connecting tube 32 of the balloon 3 is larger than the diameter of the connecting tube 32 of the balloon 3
  • 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 stent can be fully opened and adhered to the inner side surface of the blood vessel.
  • a gradual narrowing transition surface is disposed on a front side of the head end 11 , and the transition surface is passed between the inner hole wall and the outer side wall of the front side of the head end 11 Then, as shown in FIG. 7 and FIG.
  • the transition surface can be set to a smooth curved surface, so that there is no flat end surface 4 which can resist the bracket beam, and the duct can smoothly slide over the bracket beam, or as shown in FIG.
  • the transition surface includes a plurality of planes, and an angle between any adjacent two planes is an obtuse angle, so that an approximate arcuate shape is formed, and a plane connected to the inner wall of the head end 11 faces the rear side of the head end 11 Tilting, so that there is no flat end surface 4 against the bracket beam, and it can also play a smooth sliding over the bracket beam.
  • the transition surface can also be arranged as a smooth curved surface and a plane connection, as long as the front side and the head end
  • the surface of the inner wall of the eleven holes is not formed to be able to abut against the flat end surface 4 of the stent beam.
  • the smooth surface of the front side of the head end 11 is disposed outside the head end 11 and can be set to a smooth surface with different curvature according to actual needs.
  • the inner side of the outlet end of the head end 11 can also be arranged to be turned outwardly and smoothly joined to the transition surface on the outer side of the head end 11, thereby making the head
  • the end of the end 11 is smoother when in contact with the guide wire.
  • the head end 11 may be a rotating body formed by rotating a symmetrical structure around the end end 11 axis, that is, the diameter of the head end 11 as viewed along the axial direction of the head end 11.
  • the cross section is circular, or as shown in Fig. 29, the radial cross section of the head end 11 and the flexible connecting portion 4 can also be designed to be an approximately circular polygon as viewed along the axial direction of the head end 11.
  • the radial cross section of the head end 11 and the flexible connecting portion 4 can also be designed to be an approximately circular polygon as viewed along the axial direction of the head end 11.
  • FIGS. 23-24 only a portion of the front side outer surface of the head end 11 is disposed as a transition surface, and the remaining portion is disposed as a tapered surface or a sloped surface.
  • the rear side of the head end 11 can be Further, a tapered or inclined surface whose taper is directed to the rear side of the head end 11 is designed.
  • this embodiment is a quick exchange type balloon catheter, and a guide wire outlet 12 is provided in the middle of the catheter.
  • the present embodiment employs a head end 11 provided with a raised portion that fits over the end of the inner tube 1 and abuts the connecting tube 32 of the balloon 3, the head
  • the wall thickness of the main body 11 of the end 11 remains unchanged.
  • the thickness of the body of the head end 11 is 0.05-1.5 mm.
  • the front side of the head end 11 is provided with a convex portion, and the maximum outer diameter of the convex portion is larger than the head end 11
  • the outer diameter of the other portion is also larger than the distance between the bracket and the inner wall of the blood vessel, so that the bracket is fully opened to fit the inner wall of the blood vessel, and the inner side wall to the outer side wall of the front side of the head end 11 is connected by the convex portion.
  • the outer surface of the raised portion is a smooth surface, so that there is no flat end surface 4 capable of abutting the bracket beam, so that the duct smoothly slides over the bracket beam, or as shown in FIG. 18, the outer surface of the convex portion Including a plurality of planes, the angle between any two adjacent planes is an obtuse angle, so that the shape of the approximate arc surface is formed, and the plane connecting the outer surface of the boss portion to the inner wall of the head end 11 is directed toward the head end 11 The side is inclined so that there is no flat end face 4 against the bracket beam, and it can also smoothly slide over the bracket beam. Further, as shown in FIG.
  • the inner side of the outlet end of the head end 11 can also be provided as a curved surface which is turned outward and smoothly engages with the convex portion on the outer side of the head end 11, thereby The head end 11 outlet is made smoother when it comes into contact with the guide wire.
  • the outer surface of the convex portion may also be configured to be a smooth surface and a planar structure, as long as the front side is connected to the inner wall of the head end 11.
  • the flat surface 4 that can resist the bracket beam is not formed.
  • the convex portion on the head end 11 may be a rotating body formed by rotating a symmetrical structure around the axis of the head end 11, that is, any axial section of the convex portion is
  • the symmetrical structure is only that the outer edge of the axial section of the protrusion is set to have different curvatures as needed, or the protrusion on the head end 11 can also be designed in an asymmetrical form, as shown in FIGS. 13-15.
  • the two ends of the head end 11 are respectively provided with convex portions having different curvatures on the outer surface, or as shown in FIGS. 16-17, only a part of the front side outer surface of the head end 11 is provided with a convex portion, and the remaining portion is tapered.
  • the radial end section of the head end 11 may be designed to be circular, or as shown in FIG. 19, along the head end 11 Viewed axially, the radial extent of the head end 11 can also be designed to be an approximately circular polygon.
  • the present embodiment is different from the first embodiment in that the present embodiment is a guidewire (OTW) type balloon catheter, and the guide wire interface 12 is disposed on the joint 5.
  • OGW guidewire
  • the difference between the embodiment and the embodiment 1 is that: in this embodiment, a flexible connecting portion 8 is disposed between the inner tube 1 and the head end 11, and the flexible connecting portion 8 can enter the blood vessel.
  • the vascular bend is bent to further ensure that the catheter smoothly slides over the stent beam.
  • the flexible connecting portion 4 may be made of nylon, polyethylene, polypropylene, block polyamide or polyurethane, and the flexible connecting portion 4 and the head end 11 may be a separate structure or may be integrated. structure.

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Abstract

一种采用非锥状头端的球囊导管，包括内管（1）、外管（2）和球囊（3），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，所述内管的远端伸出球囊后与头端（11）相连，所述头端的壁厚非逐渐变薄，所述头端最大壁厚处外径大于或者等于头端其他部分的外径。该球囊导管在对支架进行后扩张操作时，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。

Description

一种采用非锥状头端的球囊导管 技术领域
本实用新型涉及医疗器械技术领域，具体地说是一种采用非锥状头端的球囊导管。
背景技术
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。
如图1～2所示，目前临床使用的球囊导管的头端均呈壁厚逐渐变薄的圆锥状，这种设计有利于球囊导管推力的传送，也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圆锥状，如图2所示，导管头端前侧会形成一个较小的平端面，在球囊导管沿着导丝送入支架时，导管头端前侧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。
实用新型内容
本实用新型的目的在于提供一种采用非锥状头端的球囊导管，在对支架进行后扩张操作时，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。
本实用新型的目的是通过以下技术方案来实现的：
一种采用非锥状头端的球囊导管，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，所述内管的远端伸出球囊后与头端相连，所述头端的主体壁厚非逐渐变薄，所述头端最大壁厚处外径大于或者等于头端主体其他部分的外径。
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。
当所述过渡面为非光滑面时，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，且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平面。
所述头端前侧设有凸起部，且所述头端出口处的内侧孔壁与外侧壁之间通过所述凸起部衔接，所述凸起部最大外径大于所述头端其余部分外径，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。
当所述凸起部为非光滑面时，所述凸起部包括多个平面，任意相邻两平面之间的夹角为钝角，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平面。
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。
所述头端的后侧设置成锥状或斜面。
所述头端的径向截面呈圆形或多边形。
所述内管和头端之间设有一个柔性连接部，所述柔性连接部进入血管后顺应血管弯形弯曲。
本实用新型的优点与积极效果为：
1、本实用新型头端的主体壁厚非逐渐变薄，且最大壁厚大于支架与血管内壁的距离，或者在头端设置凸起部，且所述凸起部的最大外径大于支架与血管内壁的距离，这样在后扩张操作时，导管可以顺利滑过支架梁。
2、本实用新型的头端前侧设置逐渐收窄的过渡面，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一侧呈向头端后侧倾斜的面，这样便不会形成抵住支架梁的平端面，保证导管顺利通过。
3、本实用新型头端设有凸起部时，头端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一侧呈向头端后侧倾斜的面，这样便不会形成抵住支架梁的平端面，保证导管顺利通过。
附图说明
图1为现有技术中的球囊导管远端结构示意图，
图2为图1中的A处放大图，
图3为本实用新型的实施例一的结构示意图，
图4为图3中B处放大图，
图5为图3中C处放大图，
图6为图3中D处放大图，
图7为图3中E处放大图，
图8为本实用新型为通过导丝(OTW)型球囊导管时的示意图，
图9为头端设有凸起部时的一种结构示意图，
图10为头端设有凸起部时的另一种结构示意图，
图11为头端设有凸起部时的又一种结构示意图，
图12为头端设有凸起部时的轴向视图，
图13为头端设有非对称凸起部时的一种结构示意图，
图14为头端设有非对称凸起部时的另一种结构示意图，
图15为头端设有非对称凸起部时的轴向视图，
图16为头端只设有部分凸起部时的一种结构示意图，
图17为头端只设有部分凸起部时的另一种结构示意图，
图18为头端凸起部的轴向截面边缘呈多边形时的示意图，
图19为头端凸起部的径向截面呈多边形时的示意图，
图20为头端壁厚加厚时的一种结构示意图，
图21为头端壁厚加厚时的另一种结构示意图，
图22为头端壁厚加厚时的轴向视图，
图23为头端壁厚加厚时的又一种结构示意图，
图24为图23中的头端轴向视图，
图25为头端壁厚加厚同时后侧设有锥面的一种结构示意图，
图26为头端壁厚加厚同时后侧设有锥面的又一种结构示意图，
图27为头端壁厚加厚同时后侧设有锥面的另一种结构示意图，
图28为头端壁厚加厚时轴向截面边缘呈多边形时的示意图，
图29为头端壁厚加厚时径向截面呈多边形时的示意图，
图30为内管和头端之间设有柔性连接部的示意图。
其中，1为内管，11为头端，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为平端面，5为接头，6为导管，7为应变释放管，8为柔性连接部。
具体实施方式
下面结合附图对本实用新型作进一步详述。
如图1～2所示，现有技术中的导管头端的外侧面与前端截面之间形成平端面4，在球囊导管沿着导丝送入支架时，导管头端往往会顶住支架梁。
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，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，所述外管2的近端与接头5相连，在外管2近端与接头5之间设有应变释放管7，所述应变释放管7扣设于所述接头5上，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。
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，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1.0～5.0mm，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。
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。
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。
所述内管1的远端伸出球囊3后与头端11相连，所述头端11的主体壁厚非逐渐变薄。所述头端11最大壁厚大于支架与血管内壁的距离，且所述头端11前侧不存在平端面4与支架梁相抵，以使导管顺利滑过支架梁，或者在头端11设置凸起部，所述凸起部最大外径大于支架与血管内壁的距离，且所述头端11前侧不存在平端面4与支架梁相抵，以使导管顺利滑过支架梁，在内管与头端之间还可以设置柔性连接部8。
实施例1
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。
如图7所示，本实施例中采用壁厚加厚的头端11，所述头端11套装在内管1端部并与所述球囊3的连接管32相抵，所述头端11的直径大于所述球囊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，从而能够使支架充分张开并紧贴血管内侧面。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7以及图20所示，所述过渡面可以设置成光滑弧面，这样便不存在会抵住支架梁的平端面4，且导管可以顺利滑过支架梁，或者如图28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，这样便不存在抵住支架梁的平端面4，也可以起到顺利滑过支架梁的作用，所述过渡面也可以设置成光滑弧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4即可。
如图7及图20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21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22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29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23～24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25～27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。
实施例2
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。
如图9～11所示，本实施例采用设有凸起部的头端11，所述头端11套装在内管1端部并与所述球囊3的连接管32相抵，所述头端11的主体壁厚保持不变，所述头端11的主体壁厚厚度为0.05～1.5mm，头端11前侧设有凸起部，所述凸起部的最大外径大于头端11其他部分的外径，也大于支架与血管内壁的距离，以使支架充分张开与血管内壁贴合，所述头端11前侧的内侧孔壁到外侧壁之间通过所述凸起部衔接过渡，所述凸起部外表面为光滑面，这样便不存在能够抵住支架梁的平端面4，从而使导管顺利滑过支架梁，或者如图18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，这样便不存在抵住支架梁的平端面4，也可以起到顺利滑过支架梁的作用，另外如图11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4即可。
如图9～12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13～15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16～17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径向截面可以设计成圆形，或者如图19所示，沿着所述头端11的轴向看去，所述头端11径向截面也可以设计成呈近似圆形的多边形。
实施例3
如图8所示，本实施例与实施例1的不同之处在于：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。
实施例4
如图30所示，本实施例与实施例1的不同之处在于：本实施例在内管1和头端11之间设有一个柔性连接部8，所述柔性连接部8进入血管后可以顺应血管弯形弯曲，以进一步保证导管顺利滑过支架梁。本实施例中，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，且所述柔性连接部4与头端11可以为分体结构，也可以为一体结构。

Claims (8)

  1. 一种采用非锥状头端的球囊导管，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，其特征在于：所述内管(1)的远端伸出球囊(3)后与头端(11)相连，所述头端(11)的壁厚非逐渐变薄，所述头端(11)最大壁厚处外径大于或者等于头端(11)其他部分的外径；
    所述头端(11)前侧设有一个过渡面，所述头端(11)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(11)内侧孔壁相连的一侧呈向头端(11)后侧倾斜的面。
  2. 根据权利要求1所述的采用非锥状头端的球囊导管，其特征在于：当所述过渡面为非光滑面时，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，且所述过渡面与头端(11)内侧孔壁相连的一侧呈向头端(11)后侧倾斜的平面。
  3. 根据权利要求1所述的采用非锥状头端的球囊导管，其特征在于：所述头端(11)前侧设有凸起部，且所述头端(11)出口处的内侧孔壁与外侧壁之间通过所述凸起部衔接，所述凸起部最大外径大于所述头端(11)其余部分外径，所述凸起部外表面为光滑面，或者所述凸起部与头端(11)内侧孔壁相连的一侧呈向头端(11)后侧倾斜的面。
  4. 根据权利要求3所述的采用非锥状头端的球囊导管，其特征在于：当所述凸起部为非光滑面时，所述凸起部包括多个平面，任意相邻两平面之间的夹角为钝角，所述凸起部与头端(11)内侧孔壁相连的一侧呈向头端(11)后侧倾斜的平面。
  5. 根据权利要求4所述的采用非锥状头端的球囊导管，其特征在于：所述头端(11)前侧设有不同的凸起部，或者所述头端(11)前端的外表面上只有一部分设置凸起部。
  6. 根据权利要求1所述的采用非锥状头端的球囊导管，其特征在于：所述头端(11)的后侧设置成锥状或斜面。
  7. 根据权利要求1所述的采用非锥状头端的球囊导管，其特征在于：所述头端(11)的径向截面呈圆形或多边形。
  8. 根据权利要求1所述的采用非锥状头端的球囊导管，其特征在于：所述内管(1)和头端(11)之间设有一个柔性连接部(8)，所述柔性连接部(8)进入血管后顺应血管弯形弯曲。
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