WO2022083676A1 - 医用导管及其制备方法 - Google Patents

医用导管及其制备方法 Download PDF

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Publication number
WO2022083676A1
WO2022083676A1 PCT/CN2021/125185 CN2021125185W WO2022083676A1 WO 2022083676 A1 WO2022083676 A1 WO 2022083676A1 CN 2021125185 W CN2021125185 W CN 2021125185W WO 2022083676 A1 WO2022083676 A1 WO 2022083676A1
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Prior art keywords
tube
slit
layer
medical catheter
weld line
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PCT/CN2021/125185
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English (en)
French (fr)
Inventor
吕怡然
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艾柯医疗器械(北京)有限公司
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Priority claimed from CN202022370436.3U external-priority patent/CN214050127U/zh
Priority claimed from CN202011138210.9A external-priority patent/CN112156324B/zh
Application filed by 艾柯医疗器械(北京)有限公司 filed Critical 艾柯医疗器械(北京)有限公司
Publication of WO2022083676A1 publication Critical patent/WO2022083676A1/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

Definitions

  • the present disclosure relates to the field of medical devices, and in particular, to a medical catheter and a preparation method thereof.
  • proximal tube body is hard to facilitate force transmission, while the distal end of the catheter is soft, which is easy to pass through tortuous blood vessels and avoid damage to the blood vessels.
  • the commonly used method to adjust the hardness of different positions of the catheter is to use polymer pipes with different hardness in sections, and connect the polymer pipes with different hardnesses together by hot-melt connection.
  • the proximal end of the catheter is made of polymers with higher hardness For tubing, the closer to the distal end of the catheter, the lower the hardness of the polymer tubing used.
  • a reinforcement layer is provided in some catheters, which results in another way to adjust the hardness of the catheter at different positions, that is, by adjusting the density between the braided wires in the reinforcement layer, to adjust the softness of the catheter at different positions.
  • the technical problem to be solved by the present disclosure is that the method of adjusting the softness of the catheter only by using pipes with different hardness is limited to the properties of the raw material of the pipe; only by adjusting the density of the reinforcing layer, there is a problem of reducing the coaxiality and force of the catheter. Conduction and bending resistance performance issues.
  • the inventors of the present invention can effectively adjust the distance of the catheter by processing the distal end of the inner tube to form a slit, or further processing the slit to form a weld line under the condition of a certain density of the currently available polymer pipe and the reinforcing layer. the softness of the end.
  • the inventors further coated the outer surface of the catheter with a hydrophilic coating to increase the passability of the catheter in the blood vessel.
  • some embodiments of the present disclosure provide a medical catheter, the tube body of the medical catheter includes an outer tube and an inner tube layer, the inner wall of the inner tube layer defines a catheter lumen, and the outer tube is provided with reinforcement layer, the distal end of the inner tube layer is provided with at least one slit and/or at least one weld line extending in the axial direction.
  • the slits are arranged at equal distances along the circumference of the inner tube layer, preferably, two ends of adjacent slits are aligned or offset back and forth;
  • weld lines are equally spaced along the circumference of the inner tube layer, and preferably, two ends of adjacent weld lines are aligned or offset back and forth.
  • one or more of the slits are discontinuous slits; or, one or more of the weld lines are discontinuous weld lines.
  • the slit is a linear slit or a wavy line slit; preferably, the wavy line slit is a sinusoidal waveform slit;
  • the weld line is a linear weld line or a wavy line weld line; preferably, the wavy line weld line is a sinusoidal waveform weld line.
  • the medical catheter provided by any of the above embodiments, wherein the distance L1 between the distal end of the slit and the end of the inner layer tube is more than twice the inner diameter of the catheter at the distal end of the slit; or, the weld line The distance L1 between the distal end of the tube and the end of the inner tube is more than 2 times the inner diameter of the catheter at the distal position of the weld line;
  • the length L2 of the slit or the weld line is more than 5mm and less than 1500mm;
  • the width of the slit or the weld line is 0.05-0.2 mm.
  • the outer layer tube is provided with at least one slit and/or at least one weld line extending along the axial direction;
  • the slits and/or weld lines on the outer layer tube are equally spaced along the circumference of the outer layer tube;
  • the slit on the outer layer tube is an intermittent slit
  • the weld line on the outer layer pipe is an intermittent weld line
  • the slits on the outer layer tube are linear slits or wavy line slits
  • the weld lines on the outer layer pipe are straight line weld lines or wavy line weld lines.
  • the reinforcing layer is located on the outer wall of the inner tube, and optionally, the reinforcing layer is a spring coil or a mesh braided tube.
  • the medical catheter provided by any of the above-mentioned embodiments, wherein the medical catheter further comprises a developing segment at the distal end and a tube seat at the proximal end, optionally, the proximal end of the developing segment is connected to the distal end of the outer tube. end;
  • the medical conduit also includes a hydrophilic coating, and the hydrophilic coating is disposed on the outer wall of the outer layer tube;
  • the inner layer tube is a single-layer or multi-layer tube
  • the outer layer tube is a single-layer or multi-layer tube
  • the inner layer tube is an integrally formed tube or a multi-segment fusion tube
  • the outer layer tube is an integrally formed tube or a multi-segment fusion tube
  • the present disclosure provides a method for preparing a medical catheter according to any one of the above embodiments, comprising the steps of: making a slit on the inner tube;
  • the method further comprises the steps of: hot-melting the slit to form a weld line;
  • it also includes the steps of: connecting the developing section and the outer tube together;
  • it also includes the steps of: connecting the medical catheter and the tube holder together;
  • the method further comprises the step of: coating the outermost layer of the medical catheter with a hydrophilic coating.
  • the present disclosure provides a method for preparing a medical catheter according to any of the above embodiments, comprising the following steps:
  • Making a slit on the inner tube optionally by cutting a slit on the inner tube with a blade or by cutting a slit on the inner tube with a laser;
  • the outer layer tube is placed on the outer layer of the reinforcement layer; optionally, it also includes the steps of: making a slit on the outer layer tube; ;
  • the outer layer tube, the reinforcing layer and the inner layer tube are heat-melted as a whole, so that the outer layer tube, the reinforcing layer and the inner layer tube are combined, so that the slits are welded to form weld lines.
  • the slit or weld line of the medical catheter of some embodiments of the present disclosure can effectively adjust the flexibility of the catheter according to actual needs, especially can effectively improve the flexibility of the distal end of the catheter, avoid damage to the blood vessel at the distal end of the catheter, and increase the passage of the catheter. Performance of tortuous blood vessels; in some embodiments, medical catheters using weld lines are more conducive to balancing catheter flexibility and force conductivity than catheters using slits, while avoiding interference between components.
  • hydrophilic coating on the outer surface of the medical catheter improves the passability of the catheter in the blood vessel.
  • FIG. 1 is a schematic diagram of an inner tube of some embodiments of the disclosure.
  • FIG. 2 is an overall schematic diagram of the medical catheter according to Embodiment 1 of the disclosure.
  • Fig. 3 is a partial cross-sectional view at the position marked B in Fig. 2;
  • Fig. 4 is a partial enlarged view at the position marked C in Fig. 3;
  • FIG. 5 is a schematic diagram of the slit of the inner layer tube according to Embodiment 1 of the disclosure.
  • FIG. 6 is a schematic diagram of the inner layer tube and the reinforcement layer of Embodiment 1 of the present disclosure
  • FIG. 7 is a schematic diagram of the slit of the inner layer tube according to Embodiment 2 of the present disclosure.
  • FIG. 8 is a schematic diagram of the slit of the inner layer tube according to Embodiment 3 of the present disclosure.
  • FIG. 9 is a schematic diagram of the inner layer tube slit of Embodiment 4 of the disclosure.
  • FIG. 10 is a schematic diagram of a weld line of a medical catheter according to Embodiment 5 of the disclosure.
  • FIG. 11 is a schematic diagram of the weld line of the inner layer pipe according to Embodiment 6 of the disclosure.
  • FIG. 12 is a schematic diagram of the weld line of the inner layer pipe according to Embodiment 7 of the present disclosure.
  • FIG. 13 is a schematic diagram of a medical catheter slit according to Embodiment 8 of the disclosure.
  • FIG. 14 is a schematic diagram of a weld line of a medical catheter according to Embodiment 9 of the disclosure.
  • the present disclosure provides a medical catheter, the inner lumen of which is communicated, the tube body includes an outer tube, a reinforcing layer and an inner tube layer, and the distal end of the inner tube is provided with a plurality of slits and/or a plurality of slits extending along the axial direction Weld Line.
  • the distal end of the outer tube is provided with a plurality of slits and/or a plurality of weld lines extending in the axial direction.
  • the force transmission is better compared with the medical catheter provided with the circumferentially extending slit, which facilitates the transmission of the force from the proximal end of the catheter to the distal end of the catheter along the axial direction of the catheter. .
  • the distal end of the tube body can be connected to the imaging segment, and the proximal end of the tube body can be connected to the tube base.
  • the inner layer tube and the outer layer tube can be made of polymer materials, which can be single-layered or multi-layered.
  • the inner layer tube and the outer layer tube can be a through-pipe formed by the same polymer material, or can be a hot-melt butt-jointed pipeline of multiple sections of polymer material tubes with different hardnesses.
  • the reinforcing layer can be a coil formed by braiding or winding metal wires, organic polymer wires, or composite wires.
  • the distal end of the outer tube may be connected to a developing section, and the developing section is a metal developed under X-rays or a polymer material containing a developing metal.
  • the inner tube is provided with a plurality of parallel slits or weld lines extending along the axial direction.
  • the distal end of the slits or weld lines is a slit or weld from the distal end L1 of the catheter.
  • the inner diameter of the catheter at the distal position of the scar is more than 2 times, usually L1 is more than 1mm, and the length of the slit or weld line is 5mm ⁇ L2 ⁇ 1500mm.
  • the width of the slit or weld line is 0.05-0.2 mm.
  • a hydrophilic coating is provided on the outside of the tube body, for example, an anticoagulant hydrophilic coating can be formed by coating polyvinylpyrrolidone (PVP), which can increase the passability of the catheter in the blood vessel.
  • PVP polyvinylpyrrolidone
  • Some embodiments of the present disclosure provide a method for preparing a medical catheter, comprising the steps of:
  • Slits are made in the inner tube of a machined medical catheter, for example by a blade or a laser.
  • slits may be further formed in the outer tube of the medical catheter.
  • the slitted medical catheter can be further subjected to hot-melting treatment, so that the slits are fused to form a weld line, for example, the hot-melting treatment can be performed by a common hot-melt laminator.
  • Some embodiments of the present disclosure provide a method for preparing a medical catheter, comprising the steps of:
  • a slit can be drawn in the inner tube by a blade, or a slit can be cut in the inner tube by a laser;
  • the outer tube is placed on the outer jacket of the reinforcement layer; alternatively, a slit may be made in the outer tube, for example, a slit may be drawn in the outer tube by a blade, or a slit may be cut in the outer tube by a laser;
  • the outer layer tube, the reinforcing layer and the inner layer tube are heat-melted as a whole, so that the outer layer tube, the reinforcing layer and the inner layer tube are combined, and the slits are welded to form weld lines.
  • it further includes the step of: connecting the developing section and the outer layer tube together, for example, by hot-melting or bonding.
  • it further includes the step of: connecting the medical catheter and the tube base together, for example, by means of hot-melting or bonding.
  • it includes the step of: coating the outermost layer of the medical catheter with a hydrophilic coating.
  • the medical catheter of this embodiment includes a tube body 2 , the distal end of the tube body 2 is connected to the developing section 1 by hot melt, and the proximal end of the tube body 2 is bonded to the tube base 3 .
  • 3 is a partial cross-sectional view at the position marked B at the distal end of the medical catheter in FIG. 2.
  • the catheter tube body 2 includes an outer layer tube 4, a reinforcing layer 5 and an inner layer tube 6. The distal end is connected to the proximal end of the developing segment 1 .
  • the inner tube 6 is provided with a plurality of parallel slits 7, the slits 7 extend along the axial direction on the inner tube 6, and the distance L1 between the distal end of the slit 7 and the end of the inner tube 6 is 3 mm, The length L2 of the slit 7 is 50 mm.
  • FIG. 4 is a partial enlarged view at the position marked C in FIG. 3 , showing the hydrophilic coating 8 on the outer side of the outer tube 4 .
  • FIG. 5 shows the inner tube 6 alone for further viewing of the plurality of continuous slits 71 on the inner tube 6 .
  • FIG. 6 is a schematic diagram of the remaining reinforcing layer 5 and the inner layer tube 6 after removing the outer layer tube 4 of the tube body 2 , and the reinforcing layer 5 is a mesh coil woven by metal wires.
  • the difference between the medical catheter of this embodiment and the medical catheter of Embodiment 1 is that the inner tube 6 is provided with a plurality of parallel intermittent slits 72 , and the adjacent slits 72 are Align both ends.
  • Example 2 With the aligned intermittent slits in Example 2, when the distal end of the catheter encounters a large resistance, the axially conducted stress at the slit is easily released from the distal end of the catheter to the proximal end in stages.
  • the difference between the medical catheter of this embodiment and the medical catheter of Embodiment 1 is that the inner tube 6 is provided with a plurality of parallel intermittent slits 72 , and the adjacent slits 72 are Both ends are offset a distance back and forth.
  • Example 3 Using the dislocated intermittent slits in Example 3, compared with the medical catheter in Example 2, the stress conduction capability of the catheter is further improved.
  • the difference between the medical catheter of this embodiment and the medical catheter of Embodiment 1 is that a plurality of sinusoidal waveform slits 73 are provided on the inner tube 6 , and the peaks and troughs of each slit are equal to one another.
  • the sinusoidal waveform slit 73 can improve the flexibility of the catheter tube body while ensuring the transmission of force in the axial direction and the transmission of force in the circumferential direction of the catheter (the ability to rotate coaxially). ).
  • the difference between the medical catheter of this embodiment and the medical catheter of Embodiment 1 is that the slits 7 on the inner tube 6 are welded by hot-melt treatment to form weld lines 9 .
  • the medical catheter with the weld line 9 is not as soft as the medical catheter with the slit 7, but it is easier to conduct the axial thrust of the medical catheter, and the use of the weld line helps to balance the flexibility and stress conductivity of the catheter.
  • the medical catheter using the weld line 9 can prevent the components placed inside the medical catheter from hooking the slit on the inner layer tube 6 when moving, so as to avoid peeling of the inner layer tube 6 and the tube body in some cases.
  • the difference between the medical catheter of this embodiment and the medical catheter of Embodiment 2 is that the discontinuous slits 72 on the inner tube 6 are welded by hot-melting treatment to form discontinuous weld lines 91. Similar to the medical catheter in Example 5, the use of weld lines helps to balance the flexibility and stress conductivity of the catheter, and prevents the components placed inside the medical catheter from hooking on the slits on the inner tube 6 when moving, avoiding certain problems. In some cases, the inner tube 6 and the tube body are peeled off.
  • the difference between the medical catheter of this embodiment and the medical catheter of Embodiment 4 is that the sinusoidal waveform slit 73 on the inner layer tube 6 is welded to form a sinusoidal waveform weld line by hot-melting treatment. 92. Similar to the medical catheter in Example 5, the use of weld lines helps to balance the flexibility and stress conductivity of the catheter, and prevents the components placed inside the medical catheter from hooking on the slits on the inner tube 6 when moving, avoiding certain problems. In some cases, the inner tube 6 and the tube body are peeled off.
  • the difference between the medical catheter in this embodiment and the medical catheter in Embodiment 1 is that the outer layer tube 4 is also provided with a plurality of parallel slits 7 , and the slits 7 are on the outer layer tube 4 . extends along the axial direction.
  • the additional parallel slits on the outer tube 4 of the medical catheter of this embodiment help to further improve the flexibility of the catheter.
  • the difference between the medical catheter of this embodiment and the medical catheter of Embodiment 8 is that the slits 7 on the outer layer tube 4 and the inner layer tube 6 are welded by hot-melt treatment to form a welded joint.
  • Mark 9 Similar to the medical catheter in Example 5, the use of weld lines helps to balance the flexibility and stress conductivity of the catheter, and prevents the components placed inside the medical catheter from hooking on the slits on the inner tube 6 when moving, avoiding certain problems. In some cases, the inner tube 6 and the tube body are peeled off.

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Abstract

一种医用导管及其制备方法，医用导管包括管体（2），管体（2）包括外层管（4）和内层管（6），内管层（6）的内壁限定导管内腔，外层管（4）内设加强层（5），内层管（6）远端设有沿着轴向延伸的至少一个狭缝（7）和/或至少一个熔接痕（9）。医用导管的制备方法简单，狭缝（7）或熔接痕（9）可以根据实际需求，有效调整导管的柔软程度，能够改善导管尖端的柔软性，避免导管远端对血管的损伤，增加导管通过迂曲血管的性能。

Description

医用导管及其制备方法 技术领域
本公开涉及医疗器械领域，尤其涉及一种医用导管及其制备方法。
背景技术
医用导管不同位置的柔软程度对于手术操作很重要，通常近端管体偏硬，便于力的传导，而导管的远端偏软，便于通过迂曲的血管，避免对血管造成损伤。
目前常用的调整导管不同位置硬度的方法，是分段使用不同硬度的高分子管材，通过热熔连接的方式，使不同硬度的高分子管材对接在一起，导管近端用硬度较高的高分子管材，越靠近导管远端，使用的高分子管材硬度越低。
一些导管中会设置加强层，由此产生另一种调整导管不同位置硬度的方式，即通过调整加强层中编织丝之间的密度，来调整导管不同位置的柔软度。
发明内容
本公开要解决的技术问题是，仅通过使用不同硬度的管材来调整导管柔软程度的方法，局限于管材原材料的性质；仅通过调整加强层密度的方式，存在降低导管的同轴性、力的传导和抗折弯的性能的问题。
本发明人利用目前可以使用的高分子管材和加强层密度一定的条件下，通过对内层管远端进行加工形成狭缝，或进一步对狭缝进行加工形成熔接痕，可以有效的调整导管远端的柔软程度。本发明人进一步在导管的外表面涂覆亲水涂层，增加导管在血管中的通过性。
具体来说，本公开提出了如下技术方案：
一方面，本公开一些实施方式提供了一种医用导管，所述医用导管的管体包括外层管和内管层，所述内管层的内壁限定导管内腔，所述外层管内设加强层，所述内管层远 端设有沿着轴向延伸的至少一个狭缝和/或至少一个熔接痕。
上述实施方式提供的医用导管，其中，所述狭缝沿内管层的周向等距排布，优选地，相邻狭缝的两端对齐或前后偏移；
或者，所述熔接痕沿内管层的周向等距排布，优选地，相邻熔接痕的两端对齐或前后偏移。
上述任一实施方式提供的医用导管，其中，所述狭缝中的一个或多个为断续狭缝；或者，所述熔接痕中的一个或多个为断续熔接痕。
上述任一实施方式提供的医用导管，其中，所述狭缝为直线形狭缝或波浪线形狭缝；优选地，所述波浪线形狭缝为正弦波形狭缝；
或者，所述熔接痕为直线形熔接痕或波浪线形熔接痕；优选地，所述波浪线形熔接痕为正弦波形熔接痕。
上述任一实施方式提供的医用导管，其中，所述狭缝的远端与所述内层管末端的距离L1为狭缝远端位置处的导管内径的2倍以上；或者，所述熔接痕的远端与所述内层管末端的距离L1为熔接痕远端位置处的导管内径的2倍以上；
优选地，所述狭缝或所述熔接痕的长度L2为5mm以上，1500mm以下；
优选地，所述狭缝或所述熔接痕的宽度为0.05-0.2mm。
本公开上述任一实施方式提供的医用导管，其中，所述外层管设有沿着轴向延伸的至少一个狭缝和/或至少一个熔接痕；
优选地，所述外层管上的狭缝和/或熔接痕沿外层管的周向等距排布；
可选地，所述外层管上的狭缝为断续狭缝，所述外层管上的熔接痕为断续熔接痕；
可选地，所述外层管上的狭缝为直线形狭缝或波浪线形狭缝，所述外层管上的熔接痕为直线形熔接痕或波浪线形熔接痕。
上述任一实施方式提供的医用导管，其中，所述加强层位于所述内层管的外壁，可选地，所述加强层为弹簧线圈或网状编织管。
上述任一实施方式提供的医用导管，其中，所述医用导管还包括位于远端的显影段和位于近端的管座，可选地，所述显影段的近端连接至外层管的远端；
可选地，其中，所述医用导管还包括亲水涂层，所述亲水涂层设置于所述外层管 的外壁；
可选地，所述内层管为单层或多层管，所述外层管为单层或多层管；
可选地，所述内层管为一体成型管或多段熔接管，所述外层管为一体成型管或多段熔接管。
另一方面，本公开提供了上述任一实施方式的医用导管的制备方法，包括如下步骤：在内层管上制作狭缝；
优选地，还包括步骤：对狭缝进行热熔处理形成熔接痕；
优选地，还包括步骤：将显影段和外层管连接在一起；
优选地，还包括步骤：将医用导管和管座连接在一起；
优选地，还包括步骤：在医用导管最外层涂覆亲水涂层。
另一方面，本公开提供了上述任一实施方式的医用导管的制备方法，包括如下步骤：
在内层管上制作狭缝，可选地，通过刀片在内层管上划出狭缝或者通过激光在内层管上切割出狭缝；
在具有狭缝的内层管外组装加强层；
在加强层外套上外层管；可选地，还包括步骤：在外层管上制作狭缝；可选地，通过刀片在外层管上划出狭缝或者通过激光在外层管上切割出狭缝；
对外层管、加强层和内层管整体进行热熔处理，使得外层管、加强层和内层管结合，使得狭缝熔接成熔接痕。
本公开的有益效果包括：
1.本公开一些实施方式的医用导管狭缝或熔接痕可以根据实际需求，有效调整导管的柔软程度，尤其能够有效改善导管远端的柔软性，避免导管远端对血管的损伤，增加导管通过迂曲血管的性能；一些实施方式中，采用熔接痕的医用导管相比采用狭缝的导管更有利于平衡导管柔软性和力传导性，同时还能避免部件之间的干扰。
2.本公开一些实施方式的医用导管外表面亲水涂层，提高导管在血管中的通过性。
3.本公开一些实施方式提供的制备方法易操作。
附图说明
图1为本公开一些实施方式的内层管示意图；
图2为本公开实施例1的医用导管整体示意图；
图3为图2中标记B位置处的局部剖视图；
图4为图3中标记C位置处的局部放大图；
图5为本公开实施例1的内层管狭缝示意图；
图6为本公开实施例1的内层管和加强层示意图；
图7为本公开实施例2的内层管狭缝示意图；
图8为本公开实施例3的内层管狭缝示意图；
图9为本公开实施例4的内层管狭缝示意图；
图10为本公开实施例5的医用导管熔接痕示意图；
图11为本公开实施例6的内层管熔接痕示意图；
图12为本公开实施例7的内层管熔接痕示意图；
图13为本公开实施例8的医用导管狭缝示意图；
图14为本公开实施例9的医用导管熔接痕示意图。
图中：1-显影段，2-管体，3-管座，4-外层管，5-加强层，6-内层管，7-狭缝，71-连续狭缝，72-断续狭缝，73-正弦波形狭缝，8-亲水涂层，9-熔接痕，91-断续熔接痕，92-正弦波形熔接痕。
具体实施方式
下面将结合附图对本公开的技术方案进行清楚、完整地描述。显然，基于本公开中的具体实施方式，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施方式，都属于本公开保护的范围。
需要注意的是，本文所使用的术语仅是为了描述具体实施方式，而非意图限制根 据本公开的示例性实施方式。
本公开提供了一种医用导管，其内腔连通，管体包括外层管、加强层和内管层，内层管远端设有沿着轴向延伸的多个狭缝和/或多个熔接痕。在一些实施方式中，外层管远端设有沿着轴向延伸的多个狭缝和/或多个熔接痕。当狭缝或熔接痕沿轴向方向延伸时，相比设有周向延伸狭缝的医用导管而言，力的传导更好，便于导管近端的力沿导管轴向传导到导管的远端。
在一些实施方式中，管体的远端可与显影段连接，管体的近端可与管座连接。内层管和外层管可采用高分子材料，可以为单层，也可以为多层。内层管和外层管可以为同一种高分子材料成型的通管，也可以是多段不同硬度的高分子材料管热熔对接的管道。加强层可采用金属丝、有机聚合物丝、或者复合材料丝编织或缠绕而成的线圈。
本公开的一些实施方式中，外层管的远端可与显影段连接，显影段为在X射线下显影的金属或含有显影金属的高分子材料。内层管设有多个沿着轴向延伸的平行狭缝或熔接痕，在一些实施方式中，如图1中所示，狭缝或熔接痕远端距离导管远端L1为狭缝或熔接痕远端位置处导管内径的2倍以上，通常L1为1mm以上，狭缝或熔接痕的长度5mm≤L2≤1500mm。本公开的一些实施方式中，狭缝或熔接痕的宽度为0.05-0.2mm。
本公开的一些实施方式中，管体外侧设亲水涂层，例如可以通过涂覆聚乙烯吡咯烷酮(PVP)形成抗凝血的亲水涂层，可以增加导管在血管中的通过性。
本公开的一些实施方式提供了医用导管的制备方法，包括如下步骤：
在加工成型的医用导管的内层管上制作狭缝，例如通过刀片或激光在内层管制作狭缝。
上述实施方式中，可进一步在医用导管的外层管上制作狭缝。
上述实施方式中，可进一步对划好狭缝的医用导管进行热熔处理，使得狭缝熔接成熔接痕，例如可通过常用的热熔覆膜机进行热熔处理。
本公开的一些实施方式提供了医用导管的制备方法，包括如下步骤：
在内层管上制作狭缝，例如，可以通过刀片在内层管上划出狭缝，或者通过激光在内层管上切割出狭缝；
在具有狭缝的内层管外组装加强层；
在加强层外套上外层管；可选地，可在外层管上制作狭缝，例如，可以通过刀片 在外层管上划出狭缝，或者通过激光在外层管上切割出狭缝；
对外层管、加强层和内层管整体进行热熔处理，使得外层管、加强层和内层管结合，并且使得狭缝熔接成熔接痕。
上述任一实施方式中，进一步地，包括步骤：将显影段和外层管连接在一起，例如可通过热熔或粘接的方式连接在一起。
上述任一实施方式中，进一步地，包括步骤：将医用导管和管座连接在一起，例如可通过热熔或粘接的方式连接在一起。
上述任一实施方式中，进一步地，包括步骤：在医用导管最外层涂覆亲水涂层。
下面通过具体的实施例对本公开的技术方案进一步地说明。
实施例1
如图2所示，本实施例的医用导管包括管体2，管体2的远端通过热熔连接显影段1，管体2的近端与管座3粘接在一起。图3为图2中位于医用导管远端标记B位置处的局部剖视图，从图中可以看出，导管管体2包括外层管4、加强层5和内层管6，外层管4的远端与显影段1的近端连接。内层管6上设有多个平行的狭缝7，狭缝7在内层管6上沿着轴向延伸，狭缝7的远端与所述内层管6末端的距离L1为3mm，狭缝7的长度L2为50mm。图4为图3中标记C位置处的局部放大图，显示了位于外层管4外侧的亲水涂层8。图5示出单独的内层管6，以便进一步观察内层管6上的多个连续狭缝71。图6为去除管体2的外层管4后剩余的加强层5和内层管6的示意图，加强层5为金属丝编织而成的网状线圈。
实施例2
如图7所示，本实施例的医用导管与实施例1中的医用导管相比，其区别在于，内层管6上设多个平行的断续狭缝72，相邻的狭缝72的两端对齐。
采用实施例2中的对齐的断续狭缝，当导管远端遇到较大阻力时，在狭缝处轴向传导的应力，容易从导管远端向近端阶段性释放。
实施例3
如图8所示，本实施例的医用导管与实施例1中的医用导管相比，其区别在于， 内层管6上设多个平行的断续狭缝72，相邻的狭缝72的两端前后偏移一段距离。
采用实施例3中的错位的断续狭缝，相比实施例2中的医用导管，进一步改善了导管的应力传导能力。
实施例4
如图9所示，本实施例的医用导管与实施例1中的医用导管相比，其区别在于，内层管6上设多个正弦波形狭缝73，每个狭缝的波峰和波谷一一对应。相对于前3个实施例，正弦波形狭缝73能够在提高导管管体柔顺性的同时，保证了导管在轴向方向上力的传导和在周向方向上力的传导(同轴转动的能力)。
实施例5
如图10所示，本实施例的医用导管与实施例1中的医用导管相比，其区别在于，通过热熔处理将内层管6上的狭缝7进行熔接从而形成熔接痕9。具有熔接痕9的医用导管不如具有狭缝7的医用导管柔软，但更容易传导医用导管轴向的推力，采用熔接痕有助于平衡导管的柔软性和应力传导性。另外，采用熔接痕9的医用导管能够避免放置于医用导管内部的部件移动时，勾住内层管6上的狭缝，避免某些情况下内层管6和管体剥离。
实施例6
如图11所示，本实施例的医用导管与实施例2中的医用导管相比，其区别在于，通过热熔处理将内层管6上的断续狭缝72进行熔接形成断续熔接痕91。与实施例5中的医用导管类似地，采用熔接痕有助于平衡导管的柔软性和应力传导性，避免放置于医用导管内部的部件移动时勾住内层管6上的狭缝，避免某些情况下内层管6和管体剥离。
实施例7
如图12所示，本实施例的医用导管与实施例4中的医用导管相比，其区别在于，通过热熔处理将内层管6上的正弦波形狭缝73进行熔接形成正弦波形熔接痕92。与实施例5中的医用导管类似地，采用熔接痕有助于平衡导管的柔软性和应力传导性，避免放置于医用导管内部的部件移动时勾住内层管6上的狭缝，避免某些情况下内层管6和管体剥离。
实施例8
如图13所示，本实施例的医用导管与实施例1中的医用导管相比，其区别在于，外层管4同样设有多个平行的狭缝7，狭缝7在外层管4上沿着轴向延伸。本实施例的医用导管在外层管4上增设的平行狭缝有助于进一步提高导管的柔软性。
实施例9
如图14所示，本实施例的医用导管与实施例8中的医用导管相比，其区别在于，通过热熔处理将外层管4和内层管6上的狭缝7进行熔接形成熔接痕9。与实施例5中的医用导管类似地，采用熔接痕有助于平衡导管的柔软性和应力传导性，避免放置于医用导管内部的部件移动时勾住内层管6上的狭缝，避免某些情况下内层管6和管体剥离。
以上所述，仅为本公开的具体实施方式，但本公开的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本公开揭露的技术范围内，可轻易想到变化或替换，都应涵盖在本公开的保护范围之内。因此，本公开的保护范围应以所述权利要求的保护范围为准。

Claims (10)

  1. 一种医用导管，所述医用导管的管体(2)包括外层管(4)和内管层(6)，所述内管层(6)的内壁限定导管内腔，其特征在于，所述外层管(4)内设加强层(5)，所述内管层远端(6)设有沿着轴向延伸的至少一个狭缝(7)和/或至少一个熔接痕(9)。
  2. 根据权利要求1所述的医用导管，其中，所述狭缝(7)沿内管层(6)的周向等距排布，优选地，相邻狭缝(7)的两端对齐或前后偏移；
    或者，所述熔接痕(9)沿内管层(6)的周向等距排布，优选地，相邻熔接痕(9)的两端对齐或前后偏移。
  3. 根据权利要求1或2所述的医用导管，其中，所述狭缝(7)中的一个或多个为断续狭缝(72)；或者，所述熔接痕(9)中的一个或多个为断续熔接痕(91)。
  4. 根据权利要求1-3任一项所述的医用导管，其中，所述狭缝(7)为直线形狭缝或波浪线形狭缝；优选地，所述波浪线形狭缝为正弦波形狭缝(73)；
    或者，所述熔接痕(9)为直线形熔接痕或波浪线形熔接痕；优选地，所述波浪线形熔接痕为正弦波形熔接痕(92)。
  5. 根据权利要求1-4任一项所述的医用导管，其中，所述狭缝(7)的远端与所述内层管(6)末端的距离L1为狭缝(7)远端位置处的导管内径的2倍以上；或者，所述熔接痕(9)的远端与所述内层管(6)末端的距离L1为熔接痕(9)远端位置处的导管内径的2倍以上；
    优选地，所述狭缝(7)或所述熔接痕(9)的长度L2为5mm以上，1500mm以下；
    优选地，所述狭缝(7)或所述熔接痕(9)的宽度为0.05-0.2mm。
  6. 根据权利要求1-5任一项所述的医用导管，其中，所述外层管(4)设有沿着轴向延伸的至少一个狭缝(7)和/或至少一个熔接痕(9)；
    优选地，所述外层管(4)上的狭缝(7)和/或熔接痕(9)沿外层管(4)的周向等距排布；
    可选地，所述外层管(4)上的狭缝(7)为断续狭缝(72)，所述外层管(4)上的熔接痕(9)为断续熔接痕(91)；
    可选地，所述外层管(4)上的狭缝(7)为直线形狭缝或波浪线形狭缝，所述外层管(4)上的熔接痕(9)为直线形熔接痕或波浪线形熔接痕。
  7. 根据权利要求1-6任一项所述的医用导管，其中，所述加强层(5)位于所述内层管(6)的外壁，可选地，所述加强层(5)为弹簧线圈或网状编织管。
  8. 根据权利要求1-7任一项所述的医用导管，其中，所述医用导管还包括位于远端的显影段(1)和位于近端的管座(3)，可选地，所述显影段(1)的近端连接至外层管(4)的远端；
    可选地，其中，所述医用导管还包括亲水涂层(8)，所述亲水涂层(8)设置于所述外层管(4)的外壁；
    可选地，所述内层管为单层或多层管，所述外层管为单层或多层管；
    可选地，所述内层管为一体成型管或多段熔接管，所述外层管为一体成型管或多段熔接管。
  9. 一种权利要求1-8任一项所述的医用导管的制备方法，包括如下步骤：在内层管上制作狭缝；
    优选地，还包括步骤：对狭缝进行热熔处理形成熔接痕；
    优选地，还包括步骤：将显影段和外层管连接在一起；
    优选地，还包括步骤：将医用导管和管座连接在一起；
    优选地，还包括步骤：在医用导管最外层涂覆亲水涂层。
  10. 一种权利要求1-8任一项所述的医用导管的制备方法，包括如下步骤：
    在内层管上制作狭缝，可选地，通过刀片在内层管上划出狭缝或者通过激光在内层管上切割出狭缝；
    在具有狭缝的内层管外组装加强层；
    在加强层外套上外层管；可选地，还包括步骤：在外层管上制作狭缝；可选地，通过刀片在外层管上划出狭缝或者通过激光在外层管上切割出狭缝；
    对外层管、加强层和内层管整体进行热熔处理，使得外层管、加强层和内层管结合，使得狭缝熔接成熔接痕。
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