CN117861041B - A microcatheter - Google Patents

A microcatheter Download PDF

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Publication number
CN117861041B
CN117861041B CN202410031608.4A CN202410031608A CN117861041B CN 117861041 B CN117861041 B CN 117861041B CN 202410031608 A CN202410031608 A CN 202410031608A CN 117861041 B CN117861041 B CN 117861041B
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incision
layer
reinforcement layer
microcatheter
catheter body
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CN117861041A (en
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瞿金龙
王震
李志刚
王国辉
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Shanghai Xinwei Medical Technology Co ltd
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Shanghai Xinwei Medical Technology Co ltd
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Priority to PCT/CN2024/118655 priority patent/WO2025040184A1/en
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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
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • 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
    • A61M25/008Strength or flexibility characteristics of the catheter tip
    • 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
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133Tip steering devices
    • 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
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133Tip steering devices
    • A61M25/0136Handles therefor
    • 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
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133Tip steering devices
    • A61M25/0138Tip steering devices having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
    • 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
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M2025/0042Microcatheters, cannula or the like having outside diameters around 1 mm or less
    • 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/008Strength or flexibility characteristics of the catheter tip
    • A61M2025/0081Soft tip
    • 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
    • A61M2205/33Controlling, regulating or measuring
    • 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
    • A61M2210/00Anatomical parts of the body
    • A61M2210/12Blood circulatory system

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The invention provides a microcatheter, which belongs to the technical field of microcatheters; the microcatheter comprises a handle and a catheter main body, wherein the handle is connected with the catheter main body, the catheter main body at least comprises an inner layer, an outer layer and a supporting layer arranged between the inner layer and the outer layer, a tubular reinforcing layer is arranged on the outer side wall of the outer layer of the catheter main body, a notch is arranged on the reinforcing layer, and the notch is discontinuously arranged on the reinforcing layer and is used for improving the torsion control performance of the catheter main body; mainly solves the technical problem that the prior microcatheter has slow response to torsion operation, which causes difficult operation.

Description

一种微导管A microcatheter

技术领域Technical Field

本发明属于微导管技术领域,具体涉及一种微导管。The invention belongs to the technical field of microcatheters, and in particular relates to a microcatheter.

背景技术Background technique

近年来随着心、脑血管疾病及肿瘤性疾病人数的不断增加与死亡率的持续上升,并且其较高的致残疾率使多数患者留下偏瘫、失语等症状,给临床手术带来了很大的挑战。In recent years, with the increasing number of patients suffering from cardiovascular, cerebrovascular and tumor diseases and the continuous rise in mortality, and the high disability rate, most patients are left with symptoms such as hemiplegia and aphasia, which has brought great challenges to clinical surgery.

血管介入手术具有创伤小、反应低、恢复快优点,还具有靶向性特点,能够有效治疗血管疾病,在部分领域已成为治疗心、脑血管疾病的首选治疗方式。血管介入是指在影像设备的引导下,通过穿刺血管,将导丝、导管置入到血管腔内,对病变部位进行诊断和治疗的一种方法。血管介入治疗技术是一种较新的治疗方法,适用于动脉疾病、静脉疾病、肿瘤性疾病等。Vascular intervention surgery has the advantages of less trauma, low reaction, and fast recovery. It also has targeted characteristics and can effectively treat vascular diseases. In some areas, it has become the preferred treatment for cardiovascular and cerebrovascular diseases. Vascular intervention refers to a method of diagnosing and treating lesions by puncturing blood vessels and inserting guidewires and catheters into the blood vessel cavity under the guidance of imaging equipment. Vascular intervention treatment technology is a relatively new treatment method that is suitable for arterial diseases, venous diseases, tumor diseases, etc.

现有的应用于介入手术微导管的管体部分一般由内、外两层高分子层及固定贴附安装在内、外两层高分子层之间的支撑层构成,支撑层一般由金属丝编织形成,用于支撑微导管形成管道结构,但是由于金属丝编织方式形成的支撑层在微导管推送过程中支撑力不足,另外金属丝之间容易产生滑移,从而使得在手术操作过程中当需要扭转操作微导管远端时,微导出现扭控力传送迟钝、微导管远端不能快速响应近端扭转操作的情况,导致手术操作困难。The tube body of the existing microcatheter used in interventional surgery is generally composed of inner and outer polymer layers and a support layer fixedly attached and installed between the inner and outer polymer layers. The support layer is generally formed by weaving metal wires to support the microcatheter to form a pipeline structure. However, the support layer formed by weaving metal wires has insufficient supporting force during the microcatheter pushing process. In addition, slippage is easily generated between the metal wires. As a result, when the distal end of the microcatheter needs to be twisted during the surgical operation, the microcatheter experiences slow transmission of torsion control force and the distal end of the microcatheter cannot quickly respond to the proximal twisting operation, resulting in difficulty in the surgical operation.

因此,需要提供一种针对上述现有技术不足的改进技术方案。Therefore, it is necessary to provide an improved technical solution to address the above-mentioned deficiencies in the prior art.

发明内容Summary of the invention

本发明的目的在于提供一种微导管,以解决现有的微导管对扭转操作响应缓慢导致手术操作困难的技术问题。The object of the present invention is to provide a microcatheter to solve the technical problem that the existing microcatheter responds slowly to the twisting operation, resulting in difficulty in surgical operation.

为了实现上述目的,本发明的微导管提供如下技术方案:In order to achieve the above-mentioned purpose, the microcatheter of the present invention provides the following technical solutions:

一种微导管,包括手柄、导管主体,所述手柄与导管主体连接,所述导管主体至少包括内层、外层及设置在内层与外层之间的支撑层,所述导管主体外层外侧壁上设置有管状的加强层,所述加强层上布设有增加加强层柔韧性的切口,所述切口间断地设置在加强层上,用于增加导管主体的扭控性。A microcatheter comprises a handle and a catheter body, wherein the handle is connected to the catheter body, the catheter body comprises at least an inner layer, an outer layer and a support layer arranged between the inner layer and the outer layer, a tubular reinforcement layer is arranged on the outer side wall of the outer layer of the catheter body, the reinforcement layer is provided with cuts for increasing the flexibility of the reinforcement layer, and the cuts are intermittently arranged on the reinforcement layer to increase the torsion controllability of the catheter body.

作为进一步优化的技术方案,所述切口沿加强层周向贯穿加强层设置;多个所述切口沿加强层轴向间错设置,同一周向方向设置有一个切口。As a further optimized technical solution, the incision is arranged along the circumferential direction of the reinforcement layer and penetrates the reinforcement layer; a plurality of the incisions are arranged staggered along the axial direction of the reinforcement layer, and one incision is arranged in the same circumferential direction.

作为进一步优化的技术方案,所述切口沿加强层周向延伸的角度大致在90°—180°之间。As a further optimized technical solution, the angle at which the incision extends along the circumferential direction of the reinforcement layer is approximately between 90° and 180°.

作为进一步优化的技术方案,每条所述切口两端设置有扩孔结构。As a further optimized technical solution, expansion structures are provided at both ends of each incision.

作为进一步优化的技术方案,所述扩孔结构包括由切口两个侧壁向外延倾斜延伸的喇叭口区段及与喇叭口区段连接的等径区段,所述等径区段由喇叭口区段继续向背离切口一端延伸。As a further optimized technical solution, the hole expansion structure includes a bell-mouth section extending obliquely outward from two side walls of the incision and an equal-diameter section connected to the bell-mouth section, and the equal-diameter section continues to extend from the bell-mouth section toward one end away from the incision.

作为进一步优化的技术方案,多个所述切口的布置方式为沿所述加强层螺旋绕制。As a further optimized technical solution, the plurality of cutouts are arranged in a spiral winding along the reinforcement layer.

作为进一步优化的技术方案,所述切口为沿轴向布设的贯穿加强层的直线形状,多个所述切口沿所述加强层轴向间错设置。As a further optimized technical solution, the incision is in the shape of a straight line arranged along the axial direction and penetrating the reinforcement layer, and a plurality of the incisions are staggered along the axial direction of the reinforcement layer.

作为进一步优化的技术方案,所述切口包括第一切口与第二切口,所述第一切口与所述第二切口均为沿所述加强层周向开设的弧形形状,所述第一切口与所述第二切口间错布置,所述第一切口长度大于所述第二切口,所述第一切口与所述第二切口周向均对称设置两个。As a further optimized technical solution, the incision includes a first incision and a second incision, the first incision and the second incision are both arc-shaped and opened along the circumference of the reinforcement layer, the first incision and the second incision are staggered, the length of the first incision is greater than that of the second incision, and the first incision and the second incision are symmetrically arranged in two in the circumference.

作为进一步优化的技术方案,所述第一切口与所述第二切口末端均设置有沿加强层轴向延伸的轴向孔。As a further optimized technical solution, the ends of the first incision and the second incision are both provided with axial holes extending axially along the reinforcement layer.

作为进一步优化的技术方案,所述加强层远端固定设置有软弹性区段,所述软弹性区段采用TPU材质制成。As a further optimized technical solution, a soft elastic section is fixedly provided at the far end of the reinforcement layer, and the soft elastic section is made of TPU material.

有益效果:本发明通过在导管主体外侧壁上设置管状的加强层,并在加强层上布设切口,从而使得加强层在增加导管主体整体支撑性能的基础上增加了弯曲性能,这样导管主体的整体支撑性不再单独依靠金属丝编织的支撑层,而是通过加强层增加了导管主体的扭控性能,从而方便控制微导管能够轻松到达患者的病变位置;且因加强层为整体的管体结构,在承受扭控力时整体性能更好,响应时间更短,从而增加了操作的便利性,提高操作效率。Beneficial effects: The present invention provides a tubular reinforcement layer on the outer wall of the catheter body and arranges incisions on the reinforcement layer, so that the reinforcement layer increases the bending performance on the basis of increasing the overall support performance of the catheter body. In this way, the overall support of the catheter body no longer relies solely on the support layer woven with metal wires, but the torsion control performance of the catheter body is increased by the reinforcement layer, thereby facilitating the control of the microcatheter to easily reach the patient's lesion location; and because the reinforcement layer is an integral tube structure, the overall performance is better and the response time is shorter when subjected to torsion control force, thereby increasing the convenience of operation and improving the operating efficiency.

附图说明BRIEF DESCRIPTION OF THE DRAWINGS

构成本申请的一部分的说明书附图用来提供对本发明的进一步理解,本发明的示意性实施例及其说明用于解释本发明,并不构成对本发明的不当限定。其中:The drawings constituting a part of the present application are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. Among them:

图1为本发明微导管实施例1的整体结构示意图;FIG1 is a schematic diagram of the overall structure of a microcatheter embodiment 1 of the present invention;

图2为图1中A-A方向的剖视图;Fig. 2 is a cross-sectional view taken along the A-A direction in Fig. 1;

图3为本发明微导管实施例1的加强层结构示意图;FIG3 is a schematic diagram of the structure of the reinforcement layer of the microcatheter embodiment 1 of the present invention;

图4为图3的切口放大结构示意图;FIG4 is a schematic diagram of an enlarged structure of the cutout of FIG3 ;

图5为本发明微导管实施例2的加强层结构主视示意图;FIG5 is a schematic front view of the reinforcement layer structure of the microcatheter embodiment 2 of the present invention;

图6为本发明微导管实施例2的加强层结构立体示意图;FIG6 is a perspective schematic diagram of the reinforcement layer structure of the microcatheter embodiment 2 of the present invention;

图7为本发明微导管实施例3的加强层结构主视示意图;FIG7 is a schematic front view of the reinforcement layer structure of the microcatheter embodiment 3 of the present invention;

图8为本发明微导管实施例3的加强层结构立体示意图;FIG8 is a three-dimensional schematic diagram of the reinforcing layer structure of the microcatheter embodiment 3 of the present invention;

图9为本发明微导管实施例4的加强层结构主视示意图;FIG9 is a schematic front view of the reinforcing layer structure of the microcatheter embodiment 4 of the present invention;

图10为本发明微导管实施例4的加强层结构立体示意图。FIG. 10 is a three-dimensional schematic diagram of the reinforcing layer structure of microcatheter embodiment 4 of the present invention.

图中:1、手柄;2、导管主体;201、内层;202、外层;203、支撑层;204、软弹性区段;3、内应力扩散层;4、外应力扩散层;5、加强层;501-504分别表示不同实施例中的切口(其中,加强层上第一实施例的切口为501、第二实施例的切口为502、第三实施例的切口为503、第四实施例的切口为504);5011、喇叭口区段;5012、等径区段;5041、轴向孔。In the figure: 1, handle; 2, catheter body; 201, inner layer; 202, outer layer; 203, support layer; 204, soft elastic section; 3, inner stress diffusion layer; 4, outer stress diffusion layer; 5, reinforcement layer; 501-504 respectively represent the incisions in different embodiments (wherein, the incision on the reinforcement layer of the first embodiment is 501, the incision of the second embodiment is 502, the incision of the third embodiment is 503, and the incision of the fourth embodiment is 504); 5011, bell-mouth section; 5012, equal-diameter section; 5041, axial hole.

具体实施方式Detailed ways

下面将对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅是本发明的一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员所获得的所有其他实施例,都属于本发明保护的范围。The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention belong to the scope of protection of the present invention.

在本发明的描述中,术语“纵向”、“横向”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本发明而不是要求本发明必须以特定的方位构造和操作,因此不能理解为对本发明的限制。本发明中使用的术语“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接;可以是直接相连,也可以通过中间部件间接相连,对于本领域的普通技术人员而言,可以根据具体情况理解上述术语的具体含义。In the description of the present invention, the terms "longitudinal", "lateral", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and do not require that the present invention must be constructed and operated in a specific orientation. Therefore, they cannot be understood as limitations on the present invention. The terms "connected" and "connected" used in the present invention should be understood in a broad sense. For example, they can be fixed connections or detachable connections; they can be directly connected or indirectly connected through intermediate components. For ordinary technicians in this field, the specific meanings of the above terms can be understood according to specific circumstances.

下面将参考附图并结合实施例来详细说明本发明。需要说明的是,在不冲突的情况下,本发明中的实施例及实施例中的特征可以相互组合。The present invention will be described in detail below with reference to the accompanying drawings and in combination with embodiments. It should be noted that the embodiments and features in the embodiments of the present invention can be combined with each other without conflict.

需要另外说明的是,在本发明中,“远端”统一指在手术过程中远离操作者的一端,“近端”则刚好相反,指靠近操作者的一端。It should be further explained that, in the present invention, the "distal end" uniformly refers to the end away from the operator during the operation, and the "proximal end" is just the opposite, referring to the end close to the operator.

本发明提供一种微导管,通过在微导管的导管主体外侧布置一个加强层,用来增加导管主体的整体支撑性,并通过在加强层上开设切口,从而增加加强层的柔韧性,使得导管主体在承受扭控力时整体性能更好,响应时间更短,进而增加了操作的便利性。The present invention provides a microcatheter, which arranges a reinforcement layer on the outside of a catheter body of the microcatheter to increase the overall support of the catheter body, and opens an incision on the reinforcement layer to increase the flexibility of the reinforcement layer, so that the catheter body has better overall performance and shorter response time when subjected to torsion control force, thereby increasing the convenience of operation.

实施例1Example 1

如图1、图2所示,一种微导管包括手柄1、导管主体2,手柄1通过内应力扩散层3与导管主体2连接,内应力扩散层3与手柄1连接位置外侧设置有外应力扩散层4;内应力扩散层3与外应力扩散层4方便手柄1将操纵力传递到导管主体2上,从而方便通过手柄1操控导管主体2在血管内进行相应动作。As shown in Figures 1 and 2, a microcatheter includes a handle 1 and a catheter body 2. The handle 1 is connected to the catheter body 2 through an internal stress diffusion layer 3. An external stress diffusion layer 4 is provided outside the connection position between the internal stress diffusion layer 3 and the handle 1. The internal stress diffusion layer 3 and the external stress diffusion layer 4 facilitate the handle 1 to transmit the operating force to the catheter body 2, thereby facilitating the handle 1 to control the catheter body 2 to perform corresponding actions in the blood vessel.

具体地,如图2、图3所示,导管主体2至少包括内层201、外层202及设置在内层201与外层202之间的支撑层203,支撑层203为金属丝编织结构。其中,内层201采用PTFE(即聚四氟乙烯)材质制作,PTFE材质使得导管主体2的内腔具有很好的润滑性从而便于手术器械的通过,金属丝编织结构的支撑层203虽然能够使得导管主体2具有一定的支撑性,但是在手术过程中微导管建立通路到达病变位置时,有时需要跨过复杂弯曲的血管,在这个过程中微导管需要转换方向以便能够顺利通过血管到达病变位置,此时,仅仅依靠金属丝编织结构的支撑层203支撑的微导管往往对扭矩不能快速响应,因此,在本发明中,在导管主体2外层202外侧壁上设置有管状的加强层5,加强层5由镍钛合金材质制作,本身具有一定弹性及弯曲性能,加强层5的设置从整体上增加了导管主体2的支撑性及一体性,从而使得导管主体2具有良好的扭矩响应速度。Specifically, as shown in FIG. 2 and FIG. 3 , the catheter body 2 at least includes an inner layer 201 , an outer layer 202 , and a support layer 203 disposed between the inner layer 201 and the outer layer 202 , and the support layer 203 is a metal wire braided structure. Among them, the inner layer 201 is made of PTFE (i.e. polytetrafluoroethylene) material. The PTFE material makes the inner cavity of the catheter body 2 have good lubricity, thereby facilitating the passage of surgical instruments. Although the support layer 203 of the metal wire braided structure can make the catheter body 2 have a certain support, when the microcatheter establishes a pathway to reach the lesion location during the operation, it is sometimes necessary to cross complex and curved blood vessels. In this process, the microcatheter needs to change direction so that it can smoothly pass through the blood vessels to reach the lesion location. At this time, the microcatheter supported only by the support layer 203 of the metal wire braided structure often cannot respond quickly to torque. Therefore, in the present invention, a tubular reinforcement layer 5 is provided on the outer side wall of the outer layer 202 of the catheter body 2. The reinforcement layer 5 is made of nickel-titanium alloy and has certain elasticity and bending properties. The setting of the reinforcement layer 5 increases the support and integrity of the catheter body 2 as a whole, thereby making the catheter body 2 have a good torque response speed.

为了进一步增加加强层5的柔韧性,加强层5上布设有切口501,设置切口501的目的是希望切口501使得加强层5在保证导管主体2具有一定支撑性能的基础上也能保证具有良好的弯曲性能,但是,显然并不是所有的切口501都能实现这个发明目的,比如,如果切口501连续螺旋开设在加强层5上,使得加强层5为螺旋弹簧状的结构,显然当给予加强层5扭矩时,扭矩会使得加强层5在径向发生变形,并未有效增加加强层5对扭矩的响应。因此,为了保证加强层5在具有整体性的基础上同时保证增加导管主体2的扭控性,切口501需要间断地设置在加强层5上。In order to further increase the flexibility of the reinforcing layer 5, a cutout 501 is arranged on the reinforcing layer 5. The purpose of setting the cutout 501 is to ensure that the reinforcing layer 5 has good bending performance on the basis of ensuring that the catheter body 2 has a certain support performance. However, it is obvious that not all cutouts 501 can achieve this invention purpose. For example, if the cutout 501 is continuously spirally opened on the reinforcing layer 5, so that the reinforcing layer 5 is a spiral spring-like structure, it is obvious that when a torque is given to the reinforcing layer 5, the torque will cause the reinforcing layer 5 to deform in the radial direction, and the response of the reinforcing layer 5 to the torque is not effectively increased. Therefore, in order to ensure that the reinforcing layer 5 has integrity while ensuring the increase of the torsion control of the catheter body 2, the cutout 501 needs to be intermittently arranged on the reinforcing layer 5.

在本实施例中,切口501为弧形形状,且切口501沿加强层5周向贯穿加强层5设置;多个切口501沿加强层5轴向间错设置,同一周向方向设置有一个切口501,这样使得加强层5的整体性能更好,从而保证加强层5良好的支撑性能。在本实施例中,切口501沿加强层5周向延伸的角度大致在90°—180°之间,此处需要说明的是,这个范围不包含端点值,这样可以保证加强层5良好的弯曲性能。In this embodiment, the cutout 501 is in an arc shape, and the cutout 501 is arranged along the circumferential direction of the reinforcement layer 5 and penetrates the reinforcement layer 5; a plurality of cutouts 501 are arranged staggered along the axial direction of the reinforcement layer 5, and one cutout 501 is arranged in the same circumferential direction, so that the overall performance of the reinforcement layer 5 is better, thereby ensuring good support performance of the reinforcement layer 5. In this embodiment, the angle of the cutout 501 extending along the circumferential direction of the reinforcement layer 5 is approximately between 90° and 180°. It should be noted here that this range does not include the end point value, so that good bending performance of the reinforcement layer 5 can be ensured.

由于切口501在导管主体2发生轴向弯曲时相对的两个周向延伸的侧壁会发生相对运动,此时,切口501的两端的侧壁连接发生相对运动的周向延伸的侧壁,如果切口501两端为等径的末端结构,在加强层5本体的支撑下,切口501两端的侧壁会不可避免存在微张力,每个切口501两端张力的存在,最终将在一定程度上影响加强层5整体的弯曲性能,为了降低这种情况的发生,在每条切口501两端设置有扩孔结构。Since the two circumferentially extending side walls of the incision 501 will move relative to each other when the catheter body 2 is axially bent, at this time, the side walls at both ends of the incision 501 are connected to the circumferentially extending side walls that move relative to each other. If the two ends of the incision 501 are end structures of equal diameter, under the support of the reinforcement layer 5 body, there will inevitably be micro-tension on the side walls at both ends of the incision 501. The existence of tension at both ends of each incision 501 will eventually affect the overall bending performance of the reinforcement layer 5 to a certain extent. In order to reduce the occurrence of this situation, expansion structures are provided at both ends of each incision 501.

具体如图4所示,扩孔结构包括由切口501两个侧壁向外延倾斜延伸的喇叭口区段5011及与喇叭口区段5011连接的等径区段5012,等径区段5012由喇叭口区段5011继续向背离切口501一端延伸。扩孔结构的存在,可以使得加强层5更好地传力,同时降低了等径切口501末端的微张力,即降低了切口501相对时两个周向延伸的侧壁会发生相对运动的阻力,从而有效增加了加强层5的弯曲性能。在其他实施例中,扩孔结构也可以是直径大于切口501宽度的圆孔。As shown in FIG4 , the hole expansion structure includes a bell-mouth section 5011 extending obliquely outward from the two side walls of the incision 501 and an equal-diameter section 5012 connected to the bell-mouth section 5011, and the equal-diameter section 5012 continues to extend from the bell-mouth section 5011 to the end away from the incision 501. The existence of the hole expansion structure can make the reinforcement layer 5 better transmit force, and at the same time reduce the micro-tension at the end of the equal-diameter incision 501, that is, reduce the resistance to relative movement of the two circumferentially extending side walls when the incision 501 is opposite, thereby effectively increasing the bending performance of the reinforcement layer 5. In other embodiments, the hole expansion structure can also be a circular hole with a diameter greater than the width of the incision 501.

导管主体2的整体增加加强层5,不可避免也增加了导管主体2远端的硬度,而导管主体2远端在手术过程中引导微导管整体的向前运动,为了避免了增加了硬度的导管主体2的远端在血管运动过程中碰撞血管引起对血管的损伤,在加强层5远端固定设置有软弹性区段204,软弹性区段204采用TPU(即聚氨酯弹性体)材质制成。The overall addition of the reinforcement layer 5 to the catheter body 2 inevitably increases the hardness of the distal end of the catheter body 2. The distal end of the catheter body 2 guides the overall forward movement of the microcatheter during the operation. In order to prevent the distal end of the catheter body 2 with increased hardness from colliding with the blood vessel during the movement of the blood vessel and causing damage to the blood vessel, a soft elastic section 204 is fixedly provided at the distal end of the reinforcement layer 5. The soft elastic section 204 is made of TPU (i.e., polyurethane elastomer) material.

本发明在具体使用时,通过在微导管的导管主体2外侧布置一个加强层5,用来增加导管主体2的整体支撑性,并通过在加强层5上开设间断布置的切口501,从而增加加强层5的柔韧性,使得导管主体2在承受扭控力时整体性能更好,缩短了响应时间,从而可以更快地完成器械的输送,方便手术操作。When the present invention is used in practice, a reinforcing layer 5 is arranged on the outside of the catheter body 2 of the microcatheter to increase the overall support of the catheter body 2, and intermittently arranged incisions 501 are opened on the reinforcing layer 5 to increase the flexibility of the reinforcing layer 5, so that the overall performance of the catheter body 2 is better when subjected to torsion control force, and the response time is shortened, so that the delivery of the instrument can be completed faster, which facilitates the surgical operation.

实施例2Example 2

在本实施例中,微导管的几乎所有结构与实施例1均相同,唯一的区别在于切口502为沿加强层5轴向布设的直线形状,多个切口502的布置方式为沿加强层5螺旋绕制,具体如图5、图6所示。多个切口502将加强层5形成为镂空结构,使得加强层5在保证导管主体2具有一定支撑性能的基础上也能保证具有良好的弯曲性能。In this embodiment, almost all structures of the microcatheter are the same as those of the embodiment 1, and the only difference is that the cutout 502 is a straight line arranged along the axial direction of the reinforcing layer 5, and the arrangement of the multiple cutouts 502 is spirally wound along the reinforcing layer 5, as shown in Figures 5 and 6. The multiple cutouts 502 form the reinforcing layer 5 into a hollow structure, so that the reinforcing layer 5 can ensure good bending performance while ensuring that the catheter body 2 has a certain support performance.

实施例3Example 3

在本实施例中,微导管的几乎所有结构与实施例1均相同,唯一的区别在于切口503为沿轴向布设的贯穿加强层5的直线形状,多个切口503沿加强层5轴向间错设置,具体如图7、图8所示。多个切口503将加强层5形成为镂空结构,使得加强层5在保证导管主体2具有一定支撑性能的基础上也能保证具有良好的弯曲性能。In this embodiment, almost all structures of the microcatheter are the same as those of the embodiment 1, and the only difference is that the cutout 503 is a straight line shape arranged along the axial direction and penetrating the reinforcing layer 5, and a plurality of cutouts 503 are staggered along the axial direction of the reinforcing layer 5, as shown in Figures 7 and 8. The plurality of cutouts 503 form the reinforcing layer 5 into a hollow structure, so that the reinforcing layer 5 can ensure good bending performance on the basis of ensuring that the catheter body 2 has a certain support performance.

实施例4Example 4

在本实施例中,微导管的几乎所有结构与实施例1均相同,唯一的区别在于切口504包括第一切口与第二切口,第一切口与第二切口均为沿加强层5周向开设的弧形形状,第一切口与第二切口间错布置,第一切口长度大于第二切口,第一切口与第二切口周向均对称设置两个。且第一切口与第二切口开设时相互设置在对方末端相对的位置附近,即,例如,两个相对设置的第一切口末端相对的位置由于为加强层5的本体结构,所以不可避免地此位置附近的弯曲性能相对具有切口504的位置较低,为了弥补这个位置的弯曲性能,将第二切口开设在这个位置附近,同样的道理,第一切口设置在第二切口末端相对的位置附近。这样可以增加切口504在加强层5在周向上的占有率,从而使得加强层5在保证导管主体2具有一定支撑性能的基础上也能保证具有良好的弯曲性能,具体如图9、图10所示。In this embodiment, almost all structures of the microcatheter are the same as those of the embodiment 1, and the only difference is that the incision 504 includes a first incision and a second incision, and the first incision and the second incision are both arc-shaped and opened along the circumference of the reinforcing layer 5. The first incision and the second incision are staggered, and the length of the first incision is greater than that of the second incision. The first incision and the second incision are both symmetrically arranged in two incisions in the circumference. When the first incision and the second incision are opened, they are arranged near the positions where the ends of each other are opposite to each other. That is, for example, the relative positions of the ends of the two oppositely arranged first incisions are the main structure of the reinforcing layer 5, so it is inevitable that the bending performance near this position is lower than that of the position with the incision 504. In order to compensate for the bending performance of this position, the second incision is opened near this position. For the same reason, the first incision is arranged near the position where the end of the second incision is opposite. In this way, the occupancy rate of the incision 504 in the reinforcing layer 5 in the circumferential direction can be increased, so that the reinforcing layer 5 can ensure good bending performance on the basis of ensuring that the catheter body 2 has a certain support performance, as shown in Figures 9 and 10.

为了进一步增加加强层5的弯曲性能,在第一切口与第二切口末端均设置有沿加强层5轴向延伸的轴向孔5041。这个轴向孔5041可以有助于加强层5更好地传力,使微导管更容易扭转。In order to further increase the bending performance of the reinforcing layer 5, an axial hole 5041 extending axially along the reinforcing layer 5 is provided at the ends of the first incision and the second incision. The axial hole 5041 can help the reinforcing layer 5 to transmit force better and make the microcatheter easier to twist.

实施例5Example 5

在本实施例中,微导管的几乎所有结构与实施例1均相同,唯一的区别在于加强层由近端至远端包括多个区段,每个区段上可以设置一种形式的切口,即,以上四个实施例可以相互组合,形成具有多种形式的加强层。In this embodiment, almost all structures of the microcatheter are the same as those in Embodiment 1, with the only difference being that the reinforcement layer includes a plurality of sections from the proximal end to the distal end, and a form of incision can be provided on each section, that is, the above four embodiments can be combined with each other to form reinforcement layers having a variety of forms.

可以理解的是,以上描述仅为示例性的,本申请实施例对此并不进行限定。It should be understood that the above description is merely exemplary and the embodiments of the present application do not limit this.

以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均在本发明待批权利要求保护范围之内。The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention are within the scope of protection of the pending claims of the present invention.

Claims (6)

1.一种微导管,包括手柄(1)、导管主体(2),所述手柄(1)与导管主体(2)连接,所述导管主体(2)至少包括内层(201)、外层(202)及设置在内层(201)与外层(202)之间的支撑层(203),其特征在于,所述导管主体(2)外层(202)外侧壁上设置有管状的加强层(5),所述加强层(5)上布设有切口(501、502、503、504),所述切口(501、502、503、504)间断地设置在加强层(5)上,用于增加导管主体(2)的扭控性;1. A microcatheter, comprising a handle (1) and a catheter body (2), wherein the handle (1) is connected to the catheter body (2), and the catheter body (2) comprises at least an inner layer (201), an outer layer (202), and a support layer (203) arranged between the inner layer (201) and the outer layer (202), characterized in that a tubular reinforcement layer (5) is arranged on the outer side wall of the outer layer (202) of the catheter body (2), and the reinforcement layer (5) is provided with cutouts (501, 502, 503, 504), and the cutouts (501, 502, 503, 504) are intermittently arranged on the reinforcement layer (5) to increase the torsion controllability of the catheter body (2); 所述切口(501、502、503、504)具有以下布设方式中的一种或多种设置:The incisions (501, 502, 503, 504) have one or more of the following arrangements: a),所述切口(501)沿加强层(5)周向贯穿加强层(5)设置;多个所述切口(501)沿加强层(5)轴向间错设置,同一周向方向设置有一个切口(501);a), the cutout (501) is arranged along the circumferential direction of the reinforcement layer (5) and penetrates the reinforcement layer (5); a plurality of the cutouts (501) are arranged staggered along the axial direction of the reinforcement layer (5), and one cutout (501) is arranged in the same circumferential direction; b),所述切口(502)为沿轴向布设的贯穿加强层(5)的直线形状,多个所述切口(502)的布置方式为沿所述加强层(5)螺旋绕制;b), the cutout (502) is in the shape of a straight line arranged along the axial direction and penetrating the reinforcement layer (5), and the arrangement of the plurality of cutouts (502) is in the form of a spiral winding along the reinforcement layer (5); c),所述切口(503)为沿轴向布设的贯穿加强层(5)的直线形状,多个所述切口(503)沿所述加强层(5)轴向间错设置;c) the cutout (503) is in the shape of a straight line arranged along the axial direction and penetrating the reinforcement layer (5), and a plurality of the cutouts (503) are staggered along the axial direction of the reinforcement layer (5); d),所述切口(504)包括第一切口与第二切口,所述第一切口与所述第二切口均为沿所述加强层(5)周向开设的弧形形状,所述第一切口与所述第二切口间错布置,所述第一切口长度大于所述第二切口,所述第一切口与所述第二切口周向均对称设置两个。d), the incision (504) comprises a first incision and a second incision, the first incision and the second incision are both arc-shaped and opened along the circumference of the reinforcement layer (5), the first incision and the second incision are staggered, the length of the first incision is greater than that of the second incision, and two of the first incision and two of the second incision are symmetrically arranged in the circumference. 2.根据权利要求1所述的微导管,其特征在于,当所述切口(501)的布设方式为a)时,所述切口(501)沿加强层(5)周向延伸的角度在90°—180°之间。2. The microcatheter according to claim 1, characterized in that, when the arrangement mode of the incision (501) is a), the angle at which the incision (501) extends along the circumferential direction of the reinforcement layer (5) is between 90° and 180°. 3.根据权利要求2所述的微导管,其特征在于,每条所述切口(501)两端设置有扩孔结构。3. The microcatheter according to claim 2, characterized in that both ends of each of the incisions (501) are provided with expansion structures. 4.根据权利要求3所述的微导管,其特征在于,所述扩孔结构包括由切口(501)两个侧壁向外延倾斜延伸的喇叭口区段(5011)及与喇叭口区段(5011)连接的等径区段(5012),所述等径区段(5012)由喇叭口区段(5011)继续向背离切口(501)一端延伸。4. The microcatheter according to claim 3, characterized in that the expansion structure comprises a bell-mouth section (5011) extending obliquely outward from two side walls of the incision (501) and a constant diameter section (5012) connected to the bell-mouth section (5011), and the constant diameter section (5012) continues to extend from the bell-mouth section (5011) toward one end away from the incision (501). 5.根据权利要求1所述的微导管,其特征在于,当所述切口(504)的布设方式为d)时,所述第一切口与所述第二切口末端均设置有沿加强层(5)轴向延伸的轴向孔(5041)。5. The microcatheter according to claim 1, characterized in that, when the arrangement mode of the incision (504) is d), the ends of the first incision and the second incision are both provided with an axial hole (5041) extending axially along the reinforcing layer (5). 6.根据权利要求1-5任意一项所述的微导管,其特征在于,所述加强层(5)远端固定设置有软弹性区段(204),所述软弹性区段(204)采用TPU材质制成。6. The microcatheter according to any one of claims 1 to 5, characterized in that a soft elastic section (204) is fixedly provided at the distal end of the reinforcement layer (5), and the soft elastic section (204) is made of TPU material.
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