WO2020124551A1 - 一种新型微导管 - Google Patents

一种新型微导管 Download PDF

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Publication number
WO2020124551A1
WO2020124551A1 PCT/CN2018/122658 CN2018122658W WO2020124551A1 WO 2020124551 A1 WO2020124551 A1 WO 2020124551A1 CN 2018122658 W CN2018122658 W CN 2018122658W WO 2020124551 A1 WO2020124551 A1 WO 2020124551A1
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WO
WIPO (PCT)
Prior art keywords
braided
layer
novel
proximal end
microcatheter
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PCT/CN2018/122658
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English (en)
French (fr)
Inventor
王盾
肖建平
王平
向东东
于伟
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深圳市业聚实业有限公司
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Priority to JP2021536400A priority Critical patent/JP2022515796A/ja
Publication of WO2020124551A1 publication Critical patent/WO2020124551A1/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/0045Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/005Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M25/0054Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M2025/0008Catheters; Hollow probes having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M2025/0063Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/02General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0238General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/32General characteristics of the apparatus with radio-opaque indicia

Definitions

  • the invention relates to a microcatheter, in particular to a novel microcatheter.
  • the microcatheter is the guidewire in the tiny blood vessel Provide additional support inside, and the two go forward alternately, greatly improving the ability of the guide wire to pass through the occlusive disease.
  • the guide wire After the guide wire has completed traversing the lesion, it is necessary to confirm that the guide wire is in the true lumen of the blood vessel before the next treatment operation, such as balloon dilation, stent implantation, and other technical means. Inject contrast into the distal end of the blood vessel to evaluate whether the guide wire is in the true lumen of the blood vessel.
  • the microcatheter needs to be pushed from outside the body to the lesion location, which requires the microcatheter to have strong pushing performance, anti-bending performance and tracking performance, etc., to ensure that the microcatheter accurately reaches the patient's lesion and wears it during the surgery Pass the diseased blood vessel without harming the healthy blood vessel, and at the same time facilitate the guide wire to pass through and withdraw.
  • CN107107101A describes a microcatheter used for transcatheter arterial chemoembolization TACE, the microcatheter includes: a tube seat, a diffusion stress tube, a tube body and a head end; a diffusion stress tube sleeve is sleeved on the connection between the tube seat and the tube body The outer part of the tube is fixed together with the tube base by means of reverse buckling; the tube body includes an inner lining layer, a reinforcement layer and an outer layer; the reinforcement layer includes a braided section, an overlapping section and a spiral section, where the braided section is close to the tube base and the spiral The section is close to the head end, and the overlapping section is located between the braided section and the spiral section; the spiral section is made of a single spiral wire made of a coil spring structure, the micro-catheter head end described in this patent has good flexibility, and the head end has good The shape retention ability is poor, but the pushability is poor, because there is only one braided layer at
  • US7507229B2 describes a multi-layer catheter that extends deep into the human body, including an inner lining, a braid, and an outer sheath.
  • the catheter provides the high flexibility and high strength required to pass through the vascular system.
  • the outer sheath layer is composed of 7 gradually hardening polymer materials, and the braid density of the middle braid layer changes only once, and the process of gradually hardening the microcatheter from the distal end to the proximal end cannot be achieved.
  • microcatheters are difficult to have good size and good physical properties; microcatheters cannot guarantee the gradual stiffness from the distal end to the proximal end of the catheter tube; good compliance, but push Poor performance, easy to discount; poor ability to maintain the shape of the head end, can not enter the bifurcation of the blood vessel smoothly.
  • the present invention provides a new microcatheter with good size and good physical properties, and good shape retention ability at the head end.
  • the present invention adopts the following technical solutions:
  • a novel microcatheter is provided, which is a tubular structure, including a head end, a tube body, a diffusion stress tube and a needle seat arranged in order from the distal end to the proximal end, wherein:
  • the head end is doped with developing materials, and a developing ring is provided between the head end and the tube body;
  • the tube body includes a jacket layer, a braided reinforcement layer, a braided layer and an inner lining layer in order from outside to inside;
  • the proximal end of the tube body is fixedly connected to the needle seat, and the diffusion stress tube is sleeved at the connection between the proximal end of the tube body and the needle seat.
  • the outer diameter of the head end gradually increases from the distal end to the proximal end.
  • the material of the head end is soft polyamide or soft polyurethane.
  • the developing material is one or a combination of tungsten powder, barium sulfate, bismuth trioxide, bismuth subcarbonate, or calcium tungstate.
  • proximal end face of the head end is lap welded on the braided layer, and the braided layer and the inner lining layer at the distal end of the tube body extend out of the tube body.
  • the developing ring is embedded in the head end, and the developing ring completely covers the distal end face of the braided layer.
  • the material of the developing ring is platinum-iridium alloy or gold or platinum.
  • the thickness of the inner liner layer is 0.008-0.02 mm.
  • the material of the inner lining layer is high-density polyethylene or polytetrafluoroethylene.
  • the inner diameter of the inner liner layer gradually increases from the distal end to the proximal end, the inner diameter of the distal end of the inner liner layer is 0.41-0.45 mm, and the inner diameter of the proximal end of the inner liner layer is 0.48-0.53 mm.
  • the braided layer is braided by stainless steel braided wire or nickel titanium braided double wire, and the braided wire is a round wire or a flat wire or an oval wire.
  • the number of braided threads of the braided layer is 16-32 strands
  • the braided density PPI of the braided layer gradually decreases from the distal end to the proximal end
  • the braided density PPI of the distal end of the braided layer is 220-280
  • the braid density PPI at the proximal end of the braid layer is 50-100.
  • the braided reinforcement layer is provided at the proximal end of the tube body, and the length of the braided reinforcement layer is 800-1100 mm.
  • the braided reinforcement layer is braided by stainless steel braided wire or nickel-titanium braided double wire, the braided reinforcement layer has 20-36 strands, and the braided reinforcement layer is provided with several braided reinforcements horizontally ⁇ 10. Wire 10.
  • proximal end surface of the diffusion stress tube is fixedly connected to the distal end surface of the needle holder through a buckle.
  • the hardness of the jacket layer gradually increases from the distal end to the proximal end, and the hardness of the jacket layer has a variation range of 30-71D.
  • the outer layer is composed of various polyamide, polyurethane and polyolefin materials with different hardness;
  • the outer diameter of the outer layer gradually increases from the distal end to the proximal end, the outer diameter of the distal end of the outer layer is 0.05-0.066 mm, and the inner diameter of the proximal end of the outer layer 4 is 0.81-0.92 mm.
  • a hydrophilic coating is coated on the outer surface of the jacket layer.
  • the present invention adopts the above technical solution, and compared with the prior art, has the following technical effects:
  • the novel microcatheter of the invention has strong pushing performance, anti-bending performance and tracking performance.
  • the catheter gradually hardens from the distal end to the proximal end, which can ensure the flexibility and shape retention performance of the distal end and ensure that the microcatheter is in The surgical procedure accurately reaches the patient's lesion and passes through the tortuous lesion.
  • Figure 1 is a schematic diagram of the overall structure of the new microcatheter
  • Figure 2 is a schematic diagram of the braided structure of the new microcatheter
  • Figure 3 is a schematic diagram of the cross-sectional structure of the new microcatheter body and head end
  • FIG. 4 is a schematic diagram of the braided structure of the braided layer of the new microcatheter
  • FIG. 5 is a cross-sectional view of the A-A cross-section in the new microcatheter
  • FIG. 6 is a schematic diagram of the braided structure of the braided layer in the new microcatheter
  • FIG. 7 is a schematic view of the braided structure of the braided reinforcement layer in the new microcatheter
  • FIG. 11 is a schematic diagram of the state of the new microcatheter entering the blood vessel
  • an embodiment of the present invention provides a novel microcatheter, which is a tubular structure, including a head end 1, a tube body 2, a diffusion stress tube 8 and a needle holder 3 arranged in order from the distal end to the proximal end ,
  • the head end 1 is doped with a developing material, and a developing ring 9 is provided between the head end 1 and the tube body 2
  • the tube body 2 includes a jacket layer 4, a braided reinforcement layer 7, and a braided layer 6 from outside to inside And the inner lining layer 5;
  • the proximal end of the tube body 2 is fixedly connected to the needle holder 3, and a diffusion stress tube 8 is sleeved at the connection between the proximal end of the tube body 2 and the needle holder 3.
  • the outer diameter of the head end 1 gradually increases from the distal end to the proximal end, and the head end 1 adopts a streamlined design to ensure that the head end of the microcatheter extends into Human blood vessels are smooth.
  • the material of the head end 1 is a soft polyamide or a soft polyurethane, preferably a polyether block polyamide, which has the properties of a thermoplastic elastomer due to its unique chemical structure .
  • Polyether block polyamide is the lightest engineering thermoplastic elastomer, there is no loss of mechanical properties under repeated deformation, and it is resistant to fatigue.
  • polyether block polyamide has precise dimensional stability to ensure that micro catheters are different Under the environmental conditions, the size remains unchanged, and the polyether block polyamide has good rebound and elastic recovery. When the microcatheter is pulled out of the human blood vessel, it can ensure that the microcatheter does not deform.
  • the developing material is one or more of tungsten powder, barium sulfate, bismuth trioxide, bismuth subcarbonate, or calcium tungstate.
  • the extruded tube is formed by using soft polyether block polyamide material as the base material and adding developing auxiliary materials at the same time, and the head end and the tube body are tightly combined together by a welding process.
  • the proximal end surface of the head end 1 is lap welded to the braided layer 6, and the braided layer 6 and the inner lining layer 5 at the distal end of the tube body 2 extend out of the tube body 2.
  • the proximal end of the end 1 is provided with a platform protrusion 11
  • the distal end of the tube body 2 is provided with a platform groove 12 formed by the upper end surface of the braided layer 6 and the side end surface of the outer jacket layer 4, and the tower protrusion 11 is concave with the tower
  • the grooves 12 are matched and connected, and the tower protrusion 11 and the tower groove 12 are connected by welding.
  • the developing ring 9 is embedded in the head end 1, and the developing ring 9 completely covers the distal end surface of the braid 6, and one end of the developing ring 9 Located at the junction of the tower protrusion 11 and the tower groove 12, the development ring 9 tightly binds the braided layer 6 to the inner layer, while providing the development effect, and then the extruded tube of the development head 1 is sleeved to the development
  • the ring 9 is wrapped inside by welding, so that the double development effect of the head end can be achieved, providing a good one development effect for the surgeon.
  • the thickness of the inner liner 5 is 0.008-0.02 mm. While ensuring the mechanical strength of the inner liner 5, the thickness of the inner liner 5 is controlled. Within 0.008-0.02mm to ensure the smooth insertion of the microcatheter into the human blood vessel, it will not enhance the mechanical strength of the lining layer 5 and sacrifice the overall thickness of the microcatheter.
  • the material of the imaging ring 9 is platinum-iridium alloy or gold or platinum.
  • the platinum-iridium alloy, gold, and platinum are clearly developed under X-rays, which can help medical practitioners to locate the position of the microcatheter in the blood vessel. .
  • the material of the inner lining layer 5 is high-density polyethylene or polytetrafluoroethylene. Both the high-density polyethylene and the high-density polytetrafluoroethylene are smaller in volume and have better mechanical strength. Characteristics, the use of high-density polyethylene and high-density polytetrafluoroethylene for the inner lining layer improves the overall mechanical strength of the microcatheter, while ensuring that the diameter of the microcatheter is small so that the microcatheter can smoothly enter the human blood vessel.
  • the inner diameter of the inner liner 5 gradually increases from the distal end to the proximal end, and the inner diameter of the distal end of the inner liner 5 is 0.41-0.45 mm.
  • the inner diameter of the proximal end of the liner 5 is 0.48-0.53 mm, and the inner liner 5 can provide stable support for the guide wire.
  • the braided layer 6 is braided by double wires of stainless steel braided wire or nickel-titanium braided wire.
  • the braided wire is a round wire or a flat wire or an oval wire. Braiding can enhance the flexibility and anti-folding ability of the microcatheter.
  • the number of braided wires of the braided layer 6 is 16-32 strands, the braided density PPI of the braided layer 6 gradually decreases from the distal end to the proximal end, and the braided layer 6
  • the braid density PPI of the distal end is 220-280, and the braid density PPI of the proximal end of the braid layer 6 is 50-100.
  • the hardness of the catheter changes gradually.
  • the double-wire braid is used to enhance the flexibility and anti-discount ability of the micro catheter. .
  • the braided reinforcement layer 7 is provided at the proximal end of the tube body 2.
  • the length of the braided reinforcement layer 7 is 800-1100 mm.
  • the reason why it is not fully arranged on the braided layer 6 is that the tip of the microcatheter enters the human blood vessel first, so it needs better flexibility, and the braided reinforcement layer 7 will reduce the flexibility of the local catheter to a certain extent. It is difficult for the microcatheter to enter the blood vessel of the human body, and the braided reinforcement layer 7 is arranged at the proximal end of the tube body 2.
  • the braided reinforcement layer 7 is braided with stainless steel braided wire or nickel-titanium braided wire, and the braided reinforcement layer 7 has 20 braided wires -36 strands, a number of braided reinforcing wires 10 are horizontally arranged in the braided reinforcement layer 7, and the addition of the braided reinforcement layer 7 can enhance the pushing performance and torsional performance of the tube body 2, while the microcatheter has a smaller size and improves blood vessel permeability, Especially when the lesions occur in highly tortuous collateral sites, the clinical advantages of this design of microcatheter are obvious.
  • the right end surface of the diffusion stress tube 8 is fixedly connected to the left end surface of the needle base 3 through a snap.
  • the needle base 3 uses a hard and transparent PC material to connect the micro catheter body 2
  • the proximal connecting end is expanded into a bell mouth, then insert it into the needle base 3, and then connect it to the tube body 2 with UV ultraviolet curing adhesive, the de-diffused stress tube 8 is made of soft elastomer TPE material, and the diffused stress tube 8 passes
  • the reverse button is connected to the needle base 3.
  • the hardness of the sheath 4 gradually increases from the distal end to the proximal end, the hardness of the outer sheath 4 ranges from 30 to 71D, and the hardness of the catheter gradually changes when it changes. While improving the micro-guide anti-discount ability, it also has a certain flexibility.
  • the outer layer 4 is composed of a variety of polyamide, polyurethane, and polyolefin materials with different hardnesses.
  • polyamide Has the lowest hardness
  • polyolefin has the highest hardness
  • the hardness gradient effect of the outer layer 4 is achieved by different materials with their own hardness properties.
  • the outer diameter of the outer layer 4 gradually increases from the distal end to the proximal end, the outer diameter of the distal end of the outer layer 4 is 0.05-0.066 mm, and the inner diameter of the proximal end of the outer layer 4 It is 0.81-0.92mm, and the outer layer 4 is a streamlined structure design.
  • Such a structure design is conducive to the smooth insertion of the microcatheter into human blood vessels.
  • the outer surface of the outer layer 4 is coated with a hydrophilic coating, which greatly reduces the friction coefficient of the entire microcatheter and further enhances its passing performance.
  • the present invention is difficult for the existing microcatheter to have good size and good physical properties, and it cannot guarantee that the catheter body gradually hardens from the distal end to the proximal end of the catheter body and has good flexibility, but the push performance is not good, it is easy to discount and the tip The shape retention ability is poor, and it cannot enter the blood vessel bifurcation site smoothly.
  • the invention has strong pushing performance, anti-bending performance and tracking performance, and the catheter gradually hardens from the distal end to the proximal end, which can ensure the distal end
  • the flexibility and shape retention performance ensure that the microcatheter accurately reaches the patient's lesion during the surgical procedure and passes through the tortuous diseased blood vessels.

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Abstract

一种新型微导管,为管状结构,包括从远端至近端依次设置的头端(1)、管身(2)、扩散应力管(8)以及针座(3),其中:头端(1)内掺杂有显影性物料,头端(1)和管身(2)之间设有显影环(9);管身(2)由外至内依次包括外套层(4)、编织加强层(7)、编织层(6)以及内衬层(5);以及管身(2)的近端与针座(3)固定连接,管身(2)近端与针座(3)的连接处套设有扩散应力管(8)。该微导管具有很强的推送性能、抗弯折性能和跟踪性能,同时导管从远端到近端逐渐变硬,这样能保证远端的柔顺性和形状保持性能,确保微导管在手术过程中准确到达患者病变部位并穿过迂曲病变血管。

Description

一种新型微导管 技术领域
本发明涉及一种微导管,尤其涉及一种新型微导管。
背景技术
随着社会经济的发展,国民生活方式发生了深刻的变化,尤其是人口老龄化及城镇化进程的加速,中国心血管病危险因素流行趋势明显,导致了心血管病的发病人数持续增加。目前我国患有冠状动脉慢性完全闭塞病变的患者大概有220万。
临床上,针对慢性完全闭塞病变或者血管夹层的血管进行微创介入治疗时,为了提高导丝的穿越的成功率,通常需要微导管和导丝配合使用,首先微导管为导丝在微小的血管内提供额外的支撑力,并且两者交替前行,大大提高了导丝穿越闭塞病变的能力。
在导丝完成穿越病变位置后,还需要确认导丝处于血管真腔内方可进行下一步治疗操作,比如球囊扩张、支架植入等技术手段。向血管远端注射造影剂通过影像学评估导丝是否处于血管真腔。
在手术过程中,需要将微导管从体外推送到病变位置,这就要求微导管具有很强的推送性能、抗弯折性能和跟踪性能等,确保微导管在手术过程准确到达患者病变部位并穿过病变血管,而不伤害健康的血管,同时便于导丝穿过及撤出。
现有的微导管,普遍都不能同时满足导管尺寸小,又满足推送性能、抗弯折性能和跟踪性能优良,这样增加了导丝穿越闭塞病变的难度,同时增大了对医者的操作要求,延长导管在病人的体内时间,对患者的身体影响加大。
CN 107376101 A描述了一种用于经导管动脉化疗栓塞术TACE的微导管,该微导管包括:管座、扩散应力管、管身和头端;扩散应力管套套在管座与管身连接处的外部,并通过倒扣的方式与管座固定在一起;管身包括内衬层、加强层和外套层;加强层包括编织段、搭接段和螺旋段,其中编织段靠近管座,螺旋段 靠近头端,搭接段位于编织段和螺旋段之间;螺旋段采用单根螺旋丝制成螺旋弹簧的结构,该专利表述的微导管头端具有良好的柔顺性,同时头端具有良好的形状保持能力,但是,推送性性能较差,因为近端只有的一层编织层加强,如果想提高推送性能就得增大导管的壁厚,这样会增大导管的尺寸,增大导管尺寸会增大通过迂曲血管的难度,同时增加手术的风险和难度。
US 7507229B2描述了一种用于伸入人体的深处的多层导管,包括内衬层、编织层和外护套。导管提供穿过血管系统所需的高度柔顺性和高的强度。外护套层由7种逐渐变硬的聚合物材料组成,中间编织层的编织密度只有一次变化,不能实现微导管的硬度从远端到近端逐渐变硬的过程。
综上,现有的微导管普遍存在以下问题:微导管很难兼备好的尺寸和好的物理性能;微导管不能保证从导管管身远端到近端逐渐变硬;柔顺性良好,但推送性能不佳,容易打折;头端形状保持能力不佳,无法顺利进入血管分叉部位。
发明内容
本发明为解决现有微导管所存在的上述技术问题,提供一种既有好的尺寸,又有好的物理性能,同时头端又有良好的形状保持能力的新型微导管。
为实现上述目的,本发明采用以下技术方案:
提供了一种新型微导管,为管状结构,包括从远端至近端依次设置的头端、管身、扩散应力管以及针座,其中:
所述头端内掺杂有显影性物料,所述头端和所述管身之间设有显影环;
所述管身由外至内依次包括外套层、编织加强层、编织层以及内衬层;以及
所述管身的近端与所述针座固定连接,所述管身近端与所述针座的连接处套设有所述扩散应力管。
进一步地,所述头端的外径从远端至近端逐渐变大。
进一步地,所述头端的材质为软质聚酰胺或软质聚氨酯。
进一步地,所述显影性物料为钨粉或硫酸钡或三氧化二铋或次碳酸铋或钨酸钙中的一种或几种的组合。
进一步地,所述头端的近端端面搭焊在编织层上,且所述管身远端的所述编织层和内衬层伸出所述管身。
进一步地,所述显影环嵌设于所述头端内,且所述显影环完全包覆所述编织层的远端端面。
进一步地,所述显影环的材质为铂铱合金或黄金或铂。
进一步地,所述内衬层的厚度为0.008-0.02mm。
进一步地,所述内衬层的材质为高密度聚乙烯或聚四氟乙烯。
进一步地,所述内衬层的内径从远端至近端逐渐变大,所述内衬层远端的内径为0.41-0.45mm,所述内衬层近端的内径为0.48-0.53mm。
进一步地,所述编织层由不锈钢编织丝或镍钛编织丝双丝编织而成,所述编织丝为圆丝或扁丝或椭圆丝。
进一步地,所述编织层的编织线数为16-32股,所述编织层的编织密度PPI从远端至近端逐渐变小,所述编织层远端的编织密度PPI为220-280,所述编织层近端的编织密度PPI为50-100。
进一步地,所述编织加强层设于所述管身的近端,所述编织加强层的长度为800-1100mm。
进一步地,所述编织加强层由不锈钢编织丝或镍钛编织丝双丝编织而成,所述编织加强层的编织线数为20-36股,所述编织加强层内水平设置有若干编织加强丝10。
进一步地,所述扩散应力管的近端面通过卡扣与所述针座的远端面固定连接。
进一步地,所述外套层的硬度从远端至近端逐渐变大,所述外套层的硬度的变化范围为30-71D。
进一步地,所述外套层由多种硬度不同的聚酰胺、聚氨酯以及聚烯烃材料构成;
进一步地,所述外套层的外径从远端至近端逐渐变大,所述外套层远端的外径为0.05-0.066mm,所述外套层4近端的内径为0.81-0.92mm。
进一步地,所述外套层的外表面上涂覆有亲水涂层。
本发明采用上述技术方案,与现有技术相比,具有如下技术效果:
本发明的新型微导管,具有很强的推送性能、抗弯折性能和跟踪性能,同时导管从远端到近端逐渐变硬,能保证远端的柔顺性和形状保持性能,确保微导管 在手术过程准确到达患者病变部位并穿过迂曲病变血管。
附图说明
图1为新型微导管的整体结构示意图;
图2为新型微导管的编织结构示意图;
图3为新型微导管管身和头端剖面结构示意图;
图4为新型微导管的编织层编织结构示意图;
图5为新型微导管中A-A截面的剖面图;
图6为新型微导管中编织层的编织结构示意图;
图7为新型微导管中编织加强层的编织结构示意图;
图8为新型微导管中B-B截面的剖面图;
图9为新型微导管中外套层的结构示意图;
图10为新型微导管中头端的结构示意图
图11为新型微导管进入血管的状态示意图;
其中,各附图标记为:
1-头端,2-管身,3-针座,4-外套层,5-内衬层,6-编织层,7-编织加强层,8-扩散应力管,9-显影环,10-编织加强丝,11塔台凸起,12-塔台凹槽。
具体实施方式
下面通过具体实施例对本发明进行详细和具体的介绍,以使更好的理解本发明,但是下述实施例并不限制本发明范围。
如图1-11所示,本发明实施例提供了一种新型微导管,为管状结构,包括从远端至近端依次设置的头端1、管身2、扩散应力管8以及针座3,其中:头端1内掺杂有显影性物料,头端1和管身2之间设有显影环9;管身2由外至内依次包括外套层4、编织加强层7、编织层6以及内衬层5;以及管身2的近端与针座3固定连接,管身2近端与针座3的连接处套设有扩散应力管8。
本实施例的一方面,如图1-3,9-11所示,头端1的外径从远端至近端逐渐变大,头端1采用流线型设计,保证微导管的头端伸入人体血管顺畅。
本实施例的一方面,头端1的材质为软质聚酰胺或软质聚氨酯,优选为聚醚 嵌段聚酰胺,聚醚嵌段聚酰胺由于其独特的化学结构,具备热塑性弹性体的性能,聚醚嵌段聚酰胺为最轻的工程热塑性弹性体,在反复形变下没有机械性能的损失,并且抗疲劳,同时聚醚嵌段聚酰胺为具有精确的尺寸稳定性,保证微导管在不同的环境条件下保持尺寸不变,聚醚嵌段聚酰胺良好的回弹和弹性恢复,当微导管从人体血管中抽出,可以保证微导管不变形。
本实施例的一方面,如图1-3,9-11所示,显影性物料为钨粉或硫酸钡或三氧化二铋或次碳酸铋或钨酸钙中的一种或几种,头端以软质的聚醚嵌段聚酰胺材料为基料同时加入显影的辅料形成的挤出管通,通过焊接工艺将头端与管身紧紧的结合在一起。
本实施例的一方面,如图10所示,头端1的近端端面搭焊在编织层6上,且管身2远端的编织层6和内衬层5伸出管身2,头端1的近端端面设有搭台凸起11,管身2的远端设有由编织层6的上端面和外套层4侧端面构成的搭台凹槽12,塔台凸起11与塔台凹槽12相配合连接,塔台凸起11与塔台凹槽12通过焊接连接。
本实施例的一方面,如图1-2,10-11所示,显影环9嵌设于头端1内,且显影环9完全包覆编织层6的远端端面,显影环9的一端位于塔台凸起11与塔台凹槽12的连接处,显影环9将编织层6紧紧的束缚在内层,同时提供显影的作用,然后具有显影性的管头1的挤出管套到显影环9上,通过焊接将其包裹在里面,这样可以实现头端的双重显影作用,为术者提供一个很好的一个显影效果。
本实施例的一方面,如图3,5,8,10所示,内衬层5的厚度为0.008-0.02mm,在保证内衬层5力学强度的同时,将内衬层5的厚度控制在0.008-0.02mm以内以确保微导管伸入人体血管的顺畅,不会增强内衬层5的力学强度而牺牲了微导管的整体厚度。
本实施例的一方面,显影环9的材质为铂铱合金或黄金或铂,铂铱合金、黄金以及铂在X光下显影清晰,可以帮助医学从业人员对微导管在血管中的位置进行定位。
本实施例的一方面,内衬层5的材质为高密度聚乙烯或聚四氟乙烯,高密度的聚乙烯和高密度的聚四氟乙烯均件包邮体积较小,力学强度较好的特点,内衬层选用高密度聚乙烯和高密度聚四氟乙烯提升了微导管整体的力学强度的同时, 保证微导管的直径较小以便微导管顺畅进入人体血管。
本实施例的一方面,如图3,5,8,10所示,内衬层5的内径从远端至近端逐渐变大,内衬层5远端的内径为0.41-0.45mm,内衬层5近端的内径为0.48-0.53mm,内衬层5可以为导丝提供稳定支撑。
本实施例的一方面,如图2-6,10所示,编织层6由不锈钢编织丝或镍钛编织丝双丝编织而成,编织丝为圆丝或扁丝或椭圆丝,采用双丝编织可以增强微导管的柔顺性和防打折能力。
本实施例的一方面,如图2-6,10所示,编织层6的编织线数为16-32股,编织层6的编织密度PPI从远端至近端逐渐变小,编织层6远端的编织密度PPI为220-280,编织层6近端的编织密度PPI为50-100,导管的硬度变化时渐变的,另外采用双丝编织,可以增强微导管的柔顺性和防打折能力。
本实施例的一方面,如图2-3,7-8,11所示,编织加强层7设于管身2的近端,编织加强层7的长度为800-1100mm,编织加强层7并未全面布置在编织层6上原因在于:由于微导管的头端先进入人体血管,故需要较好的柔顺性能,而编织加强层7在一定程度上会降低局部导管的柔顺性,为避免出现微导管难以进入人体血管,编织加强层7至布置在管身2的近端。
本实施例的一方面,如图2-3,7-8,11所示,编织加强层7由不锈钢编织丝或镍钛编织丝双丝编织而成,编织加强层7的编织线数为20-36股,编织加强层7内水平设置有若干编织加强丝10,增加编织加强层7能够增强管身2的推送性能以及扭转性能,同时微导管拥有较小的尺寸,提高血管的通过性,尤其当病变发生在高度迂曲的侧支部位,这种设计的微导管在临床上的优势十分明显。
本实施例的一方面,如图1所示,扩散应力管8的右端面通过卡扣与针座3的左端面固定连接,针座3以硬质透明的PC材料,将微导管管身2近端连接端扩成喇叭口,随后将其插入针座3,然后用UV紫外固化胶将其与管身2连接,去扩散应力管8以软质的弹性体TPE材料,扩散应力管8通过倒扣与针座3连接。
本实施例的一方面,如图9所示,套层4的硬度从远端至近端逐渐变大,外套层4的硬度的变化范围为30-71D,导管的硬度变化时渐变的,可以在提升微导防打折能力的同时兼具一定的柔顺性。
本实施例的一方面,如图9所示,外套层4由多种硬度不同的聚酰胺、聚氨酯以及聚烯烃材料构成,在聚酰胺、聚氨酯以及聚烯烃这三种高分子材料中,聚酰胺的硬度最低,而聚烯烃的硬度最高,通过不同材质其自身的硬度性能来实现外套层4的硬度渐变效果。
本实施例的一方面,如图9所示,外套层4的外径从远端至近端逐渐变大,外套层4远端的外径为0.05-0.066mm,外套层4近端的内径为0.81-0.92mm,外套层4为流线型结构设计,这样的结构设计有利于微导管顺畅进入人体血管。
本实施例的一方面,外套层4的外表面上涂覆有亲水涂层,极大地降低了整个微导管的摩擦系数,进一步增强他的通过性能。
本发明针对现有的微导管很难兼备好的尺寸和好的物理性能、不能保证从导管管身远端到近端逐渐变硬、柔顺性良好,但推送性能不佳,容易打折以及头端形状保持能力不佳,无法顺利进入血管分叉部位等问题,本发明具有很强的推送性能、抗弯折性能和跟踪性能,同时导管从远端到近端逐渐变硬,这样能保证远端的柔顺性和形状保持性能,确保微导管在手术过程准确到达患者病变部位并穿过迂曲病变血管。
以上对本发明微导管的具体实施例进行了详细描述,但其只是作为范例,本发明并不限制于以上描述的具体实施例。对于本领域技术人员而言,任何对本发明进行的等同修改和替代也都在本发明的范畴之中。因此,在不脱离本发明的精神和范围下所作的均等变换和修改,都应涵盖在本发明的范围内。

Claims (19)

  1. 一种新型微导管,为管状结构,其特征在于,包括从远端至近端依次设置的头端(1)、管身(2)、扩散应力管(8)以及针座(3),其中:
    所述头端(1)内掺杂有显影性物料,所述头端(1)和所述管身(2)之间设有显影环(9);
    所述管身(2)由外至内依次包括外套层(4)、编织加强层(7)、编织层(6)以及内衬层(5);以及
    所述管身(2)的近端与所述针座(3)固定连接,所述管身(2)近端与所述针座(3)的连接处套设有所述扩散应力管(8)。
  2. 根据权利要求1所述的新型微导管,其特征在于,所述头端(1)的外径从远端至近端逐渐变大。
  3. 根据权利要求2所述的新型微导管,其特征在于,所述头端(1)的材质为软质聚酰胺或软质聚氨酯。
  4. 根据权利要求1所述的新型微导管,其特征在于,所述显影性物料为钨粉或硫酸钡或三氧化二铋或次碳酸铋或钨酸钙中的一种或几种的组合。
  5. 根据权利要求1所述的新型微导管,其特征在于,所述头端(1)的近端端面搭焊在编织层(6)上,且所述管身(2)远端的所述编织层(6)和内衬层(5)伸出所述管身(2)。
  6. 根据权利要求1所述的新型微导管,其特征在于,所述显影环(9)嵌设于所述头端(1)内,且所述显影环(9)完全包覆所述编织层(6)的远端端面。
  7. 根据权利要求1所述的新型微导管,其特征在于,所述显影环(9)的材质为铂铱合金或黄金或铂。
  8. 根据权利要求1所述的新型微导管,其特征在于,所述内衬层(5)的厚度为 0.008-0.02mm。
  9. 根据权利要求8所述的新型微导管,其特征在于,所述内衬层(5)的材质为高密度聚乙烯或聚四氟乙烯。
  10. 根据权利要求1所述的新型微导管,其特征在于,所述内衬层(5)的内径从远端至近端逐渐变大,所述内衬层(5)远端的内径为0.41-0.45mm,所述内衬层(5)近端的内径为0.48-0.53mm。
  11. 根据权利要求1所述的新型微导管,其特征在于,所述编织层(6)由不锈钢编织丝或镍钛编织丝双丝编织而成,所述编织丝为圆丝或扁丝或椭圆丝。
  12. 根据权利要求1所述的新型微导管,其特征在于,所述编织层(6)的编织线数为16-32股,所述编织层(6)的编织密度PPI从远端至近端逐渐变小,所述编织层(6)远端的编织密度PPI为220-280,所述编织层(6)近端的编织密度PPI为50-100。
  13. 根据权利要求1所述的新型微导管,其特征在于,所述编织加强层(7)设于所述管身(2)的近端,所述编织加强层(7)的长度为800-1100mm。
  14. 根据权利要求1所述的新型微导管,其特征在于,所述编织加强层(7)由不锈钢编织丝或镍钛编织丝双丝编织而成,所述编织加强层(7)的编织线数为20-36股,所述编织加强层(7)内水平设置有若干编织加强丝(10)。
  15. 根据权利要求1所述的新型微导管,其特征在于,所述扩散应力管(8)的近端面通过卡扣与所述针座(3)的远端面固定连接。
  16. 根据权利要求1所述的新型微导管,其特征在于,所述外套层(4)的硬度从远端至近端逐渐变大,所述外套层(4)的硬度的变化范围为30-71D。
  17. 根据权利要求16所述的新型微导管,其特征在于,所述外套层(4)由多种硬度不同的聚酰胺、聚氨酯以及聚烯烃材料构成;
  18. 根据权利要求1所述的新型微导管,其特征在于,所述外套层(4)的外径从远端至近端逐渐变大,所述外套层(4)远端的外径为0.05-0.066mm,所述外套层(4)近端的内径为0.81-0.92mm。
  19. 根据权利要求1所述的新型微导管,其特征在于,所述外套层(4)的外表面上涂覆有亲水涂层。
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