WO2017107621A1 - 导丝导引装置和导丝导引组件 - Google Patents

导丝导引装置和导丝导引组件 Download PDF

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Publication number
WO2017107621A1
WO2017107621A1 PCT/CN2016/101706 CN2016101706W WO2017107621A1 WO 2017107621 A1 WO2017107621 A1 WO 2017107621A1 CN 2016101706 W CN2016101706 W CN 2016101706W WO 2017107621 A1 WO2017107621 A1 WO 2017107621A1
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WO
WIPO (PCT)
Prior art keywords
guide wire
guiding
guide
guidewire
channel
Prior art date
Application number
PCT/CN2016/101706
Other languages
English (en)
French (fr)
Inventor
李雷
张晓东
姜君
Original Assignee
北京奇伦天佑创业投资有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by 北京奇伦天佑创业投资有限公司 filed Critical 北京奇伦天佑创业投资有限公司
Priority to US15/778,026 priority Critical patent/US11285302B2/en
Priority to EP16877432.1A priority patent/EP3395391B1/en
Priority to JP2018528329A priority patent/JP6867389B2/ja
Priority to ES16877432T priority patent/ES2935373T3/es
Publication of WO2017107621A1 publication Critical patent/WO2017107621A1/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
    • A61M25/0067Catheters; 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
    • A61M25/0071Multiple separate lumens
    • 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
    • A61M25/09Guide wires
    • A61M25/09041Mechanisms for insertion of guide wires
    • 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
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M25/003Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
    • 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
    • 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
    • A61M25/09Guide wires
    • 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
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M25/003Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
    • A61M2025/0031Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
    • 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
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M2025/0034Multi-lumen catheters with stationary elements characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
    • 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
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M2025/0039Multi-lumen catheters with stationary elements characterized by lumina being arranged coaxially
    • 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
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026Multi-lumen catheters with stationary elements
    • A61M2025/004Multi-lumen catheters with stationary elements characterized by lumina being arranged circumferentially
    • 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
    • A61M25/09Guide wires
    • A61M2025/09166Guide wires having radio-opaque features

Definitions

  • the present invention relates to the field of interventional medical devices, and in particular to a guidewire guiding device using a guidewire guiding assembly of the device.
  • interventional treatments such as vascular stents
  • the guide wires may be entangled in the body and affect the operation.
  • the guide wires in each blood vessel are collected in the body blood vessel and extend out of the body, and at this time, a plurality of guide wires are easily entangled in the blood vessel. Therefore, the problem of intertwining a plurality of guide wires is urgently solved in the industry.
  • Another object of the present invention is to provide a guidewire guide assembly that uses the guidewire guide provided by the present invention.
  • the present invention provides a guide wire guiding device including a guiding body, wherein the guiding body is respectively provided with a main body guide wire passage and a guide wire guiding passage, the main body guide wire passage and the The guide wire guiding passages respectively penetrate the guiding body in the axial direction, and the inner end opening of the guide wire guiding passage and the inner end opening of the main body guide wire passage are axially spaced apart.
  • the guide wire guiding channels are plural, and the inner end openings of the plurality of guide wire guiding channels are axially spaced apart.
  • the plurality of guide wire guiding channels and the outer end openings of the main guide wire channels are equally spaced along the circumferential direction of the guiding body.
  • the inner end surface of the guiding body is formed as a chamfered surface along which the main guide wire passage and the guide wire guiding passage are arranged to be axially spaced apart.
  • the inner end surface of the guiding body is formed as a plurality of chamfered surfaces in a stepped structure, the plurality of chamfered surfaces are parallel, and the main guide wire passage and the guide wire guiding passage are respectively formed in different said Oblique cut surface.
  • the main guide wire passage and the guide wire guiding passage are respectively formed by a pipe and covered in the guiding body.
  • the tubes forming the main guide wire passage and the guide wire guiding passage respectively protrude from the inner end surface of the guiding body.
  • the guiding body is provided with a development indicator line extending in the axial direction.
  • the guiding body is provided with a developing marking line extending in the axial direction, the developing marking line comprising an integral section and a plurality of partial sections, the integral section being arranged on an outer side wall of the guiding body,
  • the plurality of split segments are respectively disposed on a plurality of step faces of the step structure and formed on a line between adjacent body end openings, the step faces being located between adjacent ones of the chamfered faces and mutually parallel.
  • the inner guide opening of the guidewire guiding channel and/or the body guidewire channel is flared.
  • the guiding body has a circular cross section, the chamfered surface is elliptical, and an inner end opening of the main body guide wire passage is disposed near an end of the long axis of the elliptical shape.
  • the main guidewire channel is for guiding a body guidewire through the body vessel, the guidewire guide channel for guiding a branch guidewire through a branch vessel connected to the body vessel.
  • a guidewire guide assembly comprising the guidewire guide provided by the present invention, and an external end opening for guiding a passageway from the guidewire A guidewire trap that extends into and out of the body end opening.
  • the guiding body can be inserted into the blood vessel of the body by the body guide wire passing through the body guide wire passage, and the guide wire to be guided, for example, the branch guide wire of the branch blood vessel can be introduced into the guide wire guide through the guide wire trap.
  • the guiding guide wire In the guiding channel, and because it is axially spaced from the inner end opening of the guiding wire guiding channel, the guiding guide wire can be axially displaced from the main body guide wire into the guide wire guiding channel, thereby The problem that the various types of guide wires, such as the main body guide wire and the branch guide wire, are intertwined with each other can be avoided, and the guide wire trap can be easily introduced into the guide main body through the guide wire trap, which is convenient in operation and strong in practicability.
  • FIG. 1 is a schematic structural view of a guide wire guiding assembly provided during a working process according to a preferred embodiment of the present invention
  • FIG. 2 is a schematic cross-sectional view of a guide wire guiding device according to a first embodiment of the present invention
  • FIG. 3 is a schematic cross-sectional view of a guide wire guiding device according to a second embodiment of the present invention.
  • FIG. 4 is a schematic cross-sectional view of a guide wire guiding device according to a third embodiment of the present invention.
  • orientation words used such as “inside and outside”, are defined by the human body at the time of treatment, unless otherwise stated.
  • the present invention provides a guidewire guiding device and a guidewire guiding assembly using the same.
  • the guide wire guiding device includes the guiding body 1.
  • the guiding body 1 In order to facilitate the insertion into the body without causing damage to the human body, preferably, the guiding body 1 has a circular cross section, so that the safety is better.
  • the guiding body 1 can be made of materials such as polytetrafluoroethylene, and the axial length can be determined according to different surgical requirements.
  • the main body guide wire channel 2 and the guide wire guiding channel 3 are respectively formed in the guiding body 1, and the main body guide wire channel 2 and the guide wire guiding channel 3 respectively penetrate the guiding body 1 in the axial direction. And the inner end opening of the guide wire guiding passage 3 and the inner end opening of the main body guide wire passage 2 are spaced apart.
  • the guidewire guiding assembly provided by the present invention comprises the above-described guide wire guiding device, and a guide wire catcher 5 for extending from the outer end opening of the guide wire guiding passage 3 and extending from the inner end opening.
  • the guiding body 1 can be placed into the blood vessel of the body by the body guide wire 4 passing through the body guide wire passage 2, and the guide wire to be guided can be guided by the guide wire catcher 5, for example
  • the branch guide wire 6 of the branch vessel is introduced into the guide wire guiding channel 3, and since it is axially spaced from the inner end opening of the guide wire guiding channel 3, the guide wire to be guided can be guided in the axial direction with the body.
  • the wires 4 enter the guide wire guiding channel 3 in a staggered manner from each other, thereby avoiding the problem that the main guide wires 4, the branch guide wires 6 and the like are intertwined with each other, and further catching through the guide wires.
  • the device 5 can facilitate the introduction of the guide wire to be guided into the guiding body 1, which is convenient in operation and strong in practicability.
  • the guide wire catcher 5 used in the present invention is a common component in the art.
  • the guide wire catcher 5 may be a model produced by COOK Corporation of the United States. 4-Loop Vascular Retriever trap.
  • the body guidewire 4 used in the present invention for placing the guide body 1 into a blood vessel in the body may be an additional component or may be an interventional treatment such as a body guidewire of a vascular stent placement system.
  • the guide wire guiding channels 3 are plural, and the inner end openings of the plurality of guide wire guiding channels are axially spaced apart. This will ensure that all guide wires are guided during surgery.
  • the guide wire guiding channels 3 are three to correspond to the branch guide wires 6 of the three branch blood vessels 10, respectively.
  • the number of the specific guide wire guiding passages 3 in the present invention may be determined according to the number of guide wires used in the surgery, for example, three, four or more.
  • the plurality of guide wire guiding passages 3 and the outer end openings of the main guide wire passage 2 are provided at equal intervals in the circumferential direction of the guiding body 1.
  • the plurality of guide wires drawn from the guiding body 1 can be arranged neatly, thereby facilitating connection to the corresponding extracorporeal end control device.
  • each of the guide wires has flexibility, so that even if it is bent in the guide body 1, the function of the guide wire is not affected, and entanglement does not occur.
  • the inner end surface 11 of the guiding body 1 is formed as a chamfered surface, the main guide channel 2 and the guide
  • the wire guiding passages 3 are arranged along the chamfered surface to be spaced apart in the axial direction.
  • the inner wire end openings of the plurality of wire guiding channels 3 and the body wire channel 2 may be linearly arranged along the center line of the chamfered surface, wherein the guiding body 1 is When the cross section is circular, the chamfered surface is elliptical, so that a plurality of internal end openings can be arranged along the long axis of the ellipse.
  • multiple bodies The inner end openings can also be arranged as needed.
  • the arrangement of the chamfered surfaces is such that the plurality of passage openings can be arranged in the radial direction or in the tangential direction while being disposed in the axial direction, so that the plurality of guide wires can be more conveniently separated from each other before entering the guiding body 1. There will be no entanglement.
  • the inner end surface 11 of the guide body 1 in the present embodiment is formed into a plurality of oblique structures having a stepped structure, which is not used in the overall chamfered surface mode of FIG.
  • the cutting surface, the plurality of chamfered surfaces are parallel, and the main guide wire passage 2 and the guide wire guiding passage 3 are respectively formed on different chamfered surfaces.
  • the chamfered faces may be four, and at the same time, four inner end openings of the main guide wire passage 2 and the three guide wire guide passages 3 are formed.
  • the arrangement of such a plurality of chamfered faces can also achieve the purpose of separating the plurality of passage openings from each other and ensuring that the guide wire does not wrap before entering the guide body 1.
  • the main guide wire passage 2 and the guide wire guiding passage 3 are respectively formed by the pipe 8 and covered in the guiding body 1.
  • a line 8 is shown by dashed lines. That is, the guide wire guiding device provided by the present invention can be formed by coating and fixing a plurality of independent pipes 8 by a covering material. In other possible embodiments, the guide wire guiding device provided by the present invention can also be manufactured by integrally forming a through hole on the guiding body 1 as the process permits.
  • the conduits 8 forming the main guide wire passage 2 and the guide wire guiding passage 3 are respectively guided from the guide body 1.
  • the end face of the body is convex. That is, the internal end openings of the plurality of channels are not formed on the inner end surface of the guiding body 1, but are freely disposed along the inner end opening of the tube 8, and the lengths are different, so that the introduction of the respective guide wires can also be realized. Prevent the guide wire from getting entangled.
  • the guide main body 1 is provided with a development indicator line 7 extending in the axial direction.
  • the development indicator line 7 can be viewed in real time during the operation, so that the development target is The position of the line 7 and the degree of deformation provide a basis for surgical procedures, making the procedure more accurate.
  • the development indicator line 7 comprises an integral section 71 and a plurality of partial sections 72, the integral section 71 being arranged on the outer side wall of the guiding body 1, the plurality of partial sections 72 being respectively arranged
  • the plurality of step faces of the step structure may be formed on a line between adjacent body end openings, the step faces being located between adjacent chamfer faces and parallel to each other.
  • the inner end opening of the guide wire guiding channel 3 and/or the body guide wire channel 2 is flared, and the horn is a structure that is opened to the outside of each channel, and the horn design can pass through the large mouth section
  • the guide wire is introduced, and the guide wire is stably guided through the small diameter section, which makes the operation more convenient. Thereby facilitating the introduction of the respective guide wires.
  • the inner end opening of the main body guide wire passage 2 is disposed near one end of the long axis of the elliptical shape, for example, the innermost end of the guide body 1, so that the guide wires are guided.
  • the lead passages 3 can be arranged in order along the long axis.
  • the main guide wire passage is for guiding the main body guide wire 4 passing through the main blood vessel 9
  • the guide wire guiding passage is for guiding the branch guide wire 6 passing through the branch blood vessel 10 connected to the main blood vessel.
  • the body guide wire 4 can be disposed adjacent to the side wall of the body blood vessel 9, and the chamfered surface can face the opening of the plurality of branch blood vessels 10 connected to the body blood vessel 9, so that the branch wire 6 can be more advantageously guided to the guide body.
  • the introduction of 1. The alignment of the guide wires is more orderly and tangled to avoid entanglement.
  • the guide wire guiding method provided by the present invention uses the above-mentioned guide wire guiding assembly provided by the present invention, which comprises: a. placing the main body guide wire 4 to a predetermined position; specifically The manner in which the main body guidewire 4 is placed is the same as the manner in which the guide wire is inserted during an interventional procedure such as a blood vessel stent. b. The main body guide wire 4 is inserted into the main body guide wire passage 2 and the guide main body 1 is placed into the body along the main body guide wire 4; this allows the main body guide wire 4 to function as a guide guide body 1. c.
  • the guide wire catcher 5 is inserted into the guide wire guiding channel 3 and protrudes from the internal end opening to capture the guide wire 6 to be guided; in this step, the guide wire catcher 5 can be placed into the guide wire guide in advance.
  • Leading channel 3 to be guided by the main
  • the guide body 1 can be placed in the braking position and then placed into the guide wire catcher 5.
  • the guide wire 6 to be guided is introduced into the guide wire guiding channel 3 by pulling the guide wire catcher 5.
  • each of the surgical guide wires in particular the main body guide wire 4 and the branch guide wire 6, can be guided through the guiding body 1 to extend to the outside of the body, wherein the outer ends of the respective guide wires can extend out of the guide wire guiding channel.
  • the outer end opening of the 3 is thus connected to each corresponding operating device.
  • the guide body 1 placed therein enables the extension of the various guide wires used in the surgery to be arranged in a better order without causing problems such as the guide wires being entangled with each other, so that the operation proceeds smoothly.

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Abstract

一种导丝导引装置和导丝导引组件,其中装置包括导引主体(1),所述导引主体(1)内分别设置有主体导丝通道(2)和导丝导引通道(3),所述主体导丝通道(2)和所述导丝导引通道(3)分别沿轴向贯穿所述导引主体(1),并且所述导丝导引通道(3)的体内端开口和所述主体导丝通道(2)的体内端开口沿轴向间隔设置。其中导引主体(1)可以由穿过主体导丝通道(2)的主体导丝(4)置入体内血管中,并且由于与导丝导引通道(3)的体内端开口沿轴向间隔设置,因此可以使得待引导导丝可以在轴向上与主体导丝(4)相互错开地进入导丝导引通道(3)内,从而能够避免主体导丝(4)、分支导丝(6)等各类导丝之间相互缠绕的问题。

Description

导丝导引装置和导丝导引组件 技术领域
本发明涉及介入治疗医疗器械领域,具体地,涉及一种导丝导引装置,使用该装置的导丝导引组件。
背景技术
随着心脑血管疾病的多发,介入治疗,例如血管支架等治疗越来越普遍。其中在各种介入治疗中起到引导、控制相应部件的导丝也越来越多,如果一台手术中使用的导丝过多,将可能造成导丝在体内相互缠绕而影响手术。例如,在主体血管上连接多个分支血管时,各个血管中的导丝汇集在主体血管中并延伸出体外,此时在血管中多根导丝容易发生缠绕。因此,多根导丝的相互缠绕的问题在业内亟待解决。
发明内容
本发明的一个目的是提供一种导丝导引装置,该导引装置有效避免导丝在体内相互缠绕的问题。
本发明的另一个目的是提供一种导丝导引组件,该组件使用本发明提供的导丝导引装置。
为了实现上述目的,本发明提供一种导丝导引装置,包括导引主体,所述导引主体内分别设置有主体导丝通道和导丝导引通道,所述主体导丝通道和所述导丝导引通道分别沿轴向贯穿所述导引主体,并且所述导丝导引通道的体内端开口和所述主体导丝通道的体内端开口沿轴向间隔设置。
优选地,所述导丝导引通道为多个,该多个导丝导引通道的体内端开口沿轴向间隔设置。
优选地,所述多个导丝导引通道和所述主导丝通道的体外端开口沿所述导引主体的周向等间隔设置。
优选地,所述导引主体的体内端端面形成为斜切面,所述主导丝通道和所述导丝导引通道沿该斜切面布置以在轴向上间隔开。
优选地,所述导引主体的体内端端面形成为呈台阶结构的多个斜切面,该多个斜切面平行,所述主导丝通道和所述导丝导引通道分别形成在不同的所述斜切面上。
优选地,所述主导丝通道和所述导丝导引通道分别由管路形成并包覆在所述导引主体内。
优选地,形成所述主导丝通道和所述导丝导引通道的所述管路分别从所述导引主体的体内端端面凸出。
优选地,所述导引主体上设置有沿轴向延伸的显影标示线。
优选地,所述导引主体上设置有沿轴向延伸的显影标示线,该显影标示线包括整体段和多个分体段,所述整体段布置在所述导引主体的外侧壁上,所述多个分体段分别布置在所述台阶结构的多个台阶面上并形成在相邻体内端开口之间的连线上,该台阶面位于相邻的所述斜切面之间且相互平行。
优选地,所述导丝导引通道和/或所述主体导丝通道的体内端开口呈喇叭形。
优选地,所述导引主体的截面为圆形,所述斜切面为椭圆形,所述主体导丝通道的体内端开口接近所述椭圆形的长轴的一端设置。
优选地,所述主导丝通道用于引导穿过主体血管的主体导丝,所述导丝导引通道用于引导穿过连接在该主体血管上的分支血管的分支导丝。
根据本发明的另一方面,提供一种导丝导引组件,所述导丝导引组件包括本发明提供的导丝导引装置,以及用于从所述导丝导引通道的体外端开口伸入并从体内端开口伸出的导丝捕捉器。
通过上述技术方案,导引主体可以由穿过主体导丝通道的主体导丝置入体内血管中,并且可以通过导丝捕捉器将待导引导丝,例如分支血管的分支导丝引入导丝导引通道内,并且由于与导丝导引通道的体内端开口沿轴向间隔设置,因此可以使得待引导导丝可以在轴向上与主体导丝相互错开地进入导丝导引通道内,从而能够避免主体导丝、分支导丝等各类导丝之间相互缠绕的问题,进一步地通过导丝捕捉器可以便于将待引导的导丝引入导引主体中,操作方便、实用性强。
本发明的其他特征和优点将在随后的具体实施方式部分予以详细说明。
附图说明
附图是用来提供对本发明的进一步理解,并且构成说明书的一部分,与下面的具体实施方式一起用于解释本发明,但并不构成对本发明的限制。在附图中:
图1是本发明优选实施方式提供的导丝导引组件在工作过程中的结构示意图;
图2是本发明第一实施方式提供的导丝导引装置的横截面示意图;
图3是本发明第二实施方式提供的导丝导引装置的横截面示意图;
图4是本发明第三实施方式提供的导丝导引装置的横截面示意图。
附图标记说明
1    导引主体            2    主体导丝通道
3    导丝导引通道        4    主体导丝
5    导丝捕捉器          6    分支导丝
7    显影标示线          8    管路
9    主体血管            10   分支血管
11   体内端端面
具体实施方式
以下结合附图对本发明的具体实施方式进行详细说明。应当理解的是,此处所描述的具体实施方式仅用于说明和解释本发明,并不用于限制本发明。
在本发明中,在未作相反说明的情况下,使用的方位词如“内、外”是以治疗时人体为定义的,
如图1至图4所示,本发明提供一种导丝导引装置,以及使用该装置的导丝导引组件。其中导丝导引装置包括导引主体1,为了便于置入体内而不对人体造成损伤,优选地,导引主体1的截面为圆形,从而安全性更好。其中导引主体1可以使用聚四氟乙烯等材料制成,其轴向长度可以根据不同的手术要求而定。
其中为了实现本发明的目的,导引主体1内分别形成有主体导丝通道2和导丝导引通道3,主体导丝通道2和导丝导引通道3分别沿轴向贯穿导引主体1,并且导丝导引通道3的体内端开口和主体导丝通道2的体内端开口间隔设置。另外本发明提供的导丝导引组件包括上述导丝导引装置,以及用于从导丝导引通道3的体外端开口伸入并从体内端开口伸出的导丝捕捉器5。
因此,在本发明上述的技术方案中,导引主体1可以由穿过主体导丝通道2的主体导丝4置入体内血管中,并且可以通过导丝捕捉器5将待导引导丝,例如分支血管的分支导丝6引入导丝导引通道3内,并且由于与导丝导引通道3的体内端开口沿轴向间隔设置,因此可以使得待引导导丝可以在轴向上与主体导丝4相互错开地进入导丝导引通道3内,从而能够避免主体导丝4、分支导丝6等各类导丝之间相互缠绕的问题,进一步地通过导丝捕捉 器5可以便于将待引导的导丝引入导引主体1中,操作方便、实用性强。
其中本发明中使用导丝捕捉器5为本领域内常见部件,例如在本实施方式中,导丝捕捉器5可以是美国COOK公司生产的型号为
Figure PCTCN2016101706-appb-000001
4-Loop Vascular Retriever(血管内抓捕器)的捕捉器。在其他实施方式中,只要能够实现对导丝的捕捉器均应落在本发明的保护范围中。另外,本发明中使用的用于将导引主体1置入体内血管的主体导丝4可以是额外部件也可以是介入治疗中,例如血管支架置入系统的主体导丝。
其中为了导引更多的导丝,在本实施方式中,导丝导引通道3为多个,该多个导丝导引通道的体内端开口沿轴向间隔设置。这样可以保证手术中所有导丝均得到导引。作为一种实施例,导丝导引通道3为三个,以分别对应三个分支血管10中的分支导丝6。其中,本发明中具体的导丝导引通道3的数量可以根据手术中使用的导丝数量而定,例如三个、四根或更多。
另外,如图2所示,在本实施方式中,多个导丝导引通道3和主导丝通道2的体外端开口沿导引主体1的周向等间隔设置。从而使得从导引主体1引出的多个导丝能够整齐布置,从而便于连接至相应的体外端控制装置上。其中由于多个导丝导引通道3和主导丝通道2的体内端开口沿轴向间隔设置,因此部分导丝导引通道3在导引主体1内会呈弯曲状布置,由于各通道相互分隔,并且各导丝均具有柔性,因此在导引主体1内即使弯曲也不会影响导丝功能,同时也不会发生缠绕。
如图1所示,为了便于在体内端形成沿轴向间隔的各个端口,在本发明的第一实施方式中,导引主体1的体内端端面11形成为斜切面,主导丝通道2和导丝导引通道3沿该斜切面布置以在轴向上间隔开。其中在导丝导引通道3为多个的情况下,多个导丝导引通道3和主体导丝通道2的体内端开口可以沿斜切面的中心线直线布置,其中在导引主体1的截面为圆形时,斜切面为椭圆型,因此多个体内端开口可以沿椭圆的长轴布置。另外,多个体 内端开口也可以根据需要异线布置。通过这种斜切面的设置,不仅便于布置多个通道口,而且可以便于导引主体1在体内的移动,移到引导作用。另外,斜切面的布置是的多个通道口在沿轴向设置的同时还能够沿径向或切向布置,从而使得多个导丝在进入导引主体1前能够更方便地相互隔开,而不会发生缠绕。
如图3所示,在本发明的第二实施方式中,不用于图1中的整体斜切面方式,本实施方式中的导引主体1的体内端端面11形成为呈台阶结构的多个斜切面,该多个斜切面平行,主导丝通道2和导丝导引通道3分别形成在不同的斜切面上。具体地,斜切面可以为四个,也同时形成一个主导丝通道2和三个导丝导引通道3的四个体内端开口。这种多个斜切面的布置方式同样可以实现多个通道口相互隔开的目的,并且保证导丝在进入导引主体1之前不发生缠绕。
在本发明的实施方式中,为了方便加工制造导丝导引装置,优选地,主导丝通道2和导丝导引通道3分别由管路8形成并包覆在导引主体1内。如图1所示,通过虚线显示了一条管路8。即,通过包覆材料将多个独立的管路8进行包覆固定既可以形成本发明提供的导丝导引装置。在其他可能的实施方式中,在工艺允许的情况下,也可以通过在导引主体1上一体成型出通孔而制造加工制造出本发明提供的导丝导引装置。
如图4所示,在本发明的第三实施方式中,不同于第一和第二实施方式的是,形成主导丝通道2和导丝导引通道3的管路8分别从导引主体1的体内端端面凸出。即,多个通道的体内端开口不形成在导引主体1的体内端端面上,而是随管路8的体内端开口自由设置,并且长短各异,这样也可以实现各导丝的引入并防止导丝缠绕。
在本实施方式中,为了便于操作,导引主体1上设置有沿轴向延伸的显影标示线7。其中显影标示线7可以在手术中实时观看,这样,通过显影标 示线7的位置以及变形程度来为手术操作提供依据,使得手术更加精确。在本发明提供的第二实施方式中,显影标示线7包括整体段71和多个分体段72,整体段71布置在导引主体1的外侧壁上,多个分体段72分别布置在台阶结构的多个台阶面上并可以形成在相邻体内端开口之间的连线上,该台阶面位于相邻的斜切面之间且相互平行。这样,除整体段71的作用,通过多个分体段72还可以辅助标识各个通道口的位置,使得操作更加精确快捷。
另外,优选地,导丝导引通道3和/或主体导丝通道2的体内端开口呈喇叭形,该喇叭形为向各通道的外侧张开的结构,该喇叭形的设计可以通过大口段引入导丝,而通过小口径段稳定地导引导丝,使得操作更加方便。从而便于各导丝的引入。
另外,为了便于引导多个导丝,在本实施方式中,主体导丝通道2的体内端开口接近椭圆形的长轴的一端设置,例如导引主体1的最内端,这样各导丝导引通道3可以沿长轴依次布置。另外在本实施方式中,主导丝通道用于引导穿过主体血管9的主体导丝4,导丝导引通道用于引导穿过连接在该主体血管上的分支血管10的分支导丝6。这样,主体导丝4可以贴近主体血管9的侧壁布置,而斜切面可以面向连接在主体血管9上的多个分支血管10的开口,从而可以更加有利于各分支导丝6向导引主体1的引入。使得各导丝的排列更加有序整齐,避免发生缠绕。
下面对本发明提供的导丝导引方法进行描述,其中该导丝导引方法使用本发明提供的上述导丝导引组件,其中包括:a.将主体导丝4置入到预定位置;具体地置入主体导丝4的方式与例如血管支架等介入手术中的导丝置入方式相同。b.将主体导丝4穿入主体导丝通道2并将导引主体1沿主体导丝4置入体内;这样可以使得主体导丝4起到导引导引主体1的作用。c.将导丝捕捉器5穿入导丝导引通道3并伸出体内端开口以捕捉到待导引导丝6;在这一步骤中,可以事先将导丝捕捉器5置入导丝导引通道3中,待导引主 体1运动到指定位置后再伸出,也可以在导引主体1运动到制动位置后,再置入导丝捕捉器5。最后d.通过拉动导丝捕捉器5将待导引导丝6引入导丝导引通道3。这样,可以将各个手术用的导丝,尤其主体导丝4和分支导丝6均通过导引主体1进行导引而延伸到体外,其中各个导丝的体外端可以延伸出导丝导引通道3的体外端开口从而与各个对应的操作装置相连。这样,通过置入的导引主体1能够使得手术中使用的各种导丝在体内的延伸以较好的顺序进行排列,而不会发生导丝相互缠绕等问题,使得手术顺利进行。
以上结合附图详细描述了本发明的优选实施方式,但是,本发明并不限于上述实施方式中的具体细节,在本发明的技术构思范围内,可以对本发明的技术方案进行多种简单变型,这些简单变型均属于本发明的保护范围。
另外需要说明的是,在上述具体实施方式中所描述的各个具体技术特征,在不矛盾的情况下,可以通过任何合适的方式进行组合,为了避免不必要的重复,本发明对各种可能的组合方式不再另行说明。
此外,本发明的各种不同的实施方式之间也可以进行任意组合,只要其不违背本发明的思想,其同样应当视为本发明所公开的内容。

Claims (13)

  1. 一种导丝导引装置,包括导引主体(1),其特征在于,所述导引主体(1)内分别设置有主体导丝通道(2)和导丝导引通道(3),所述主体导丝通道(2)和所述导丝导引通道(3)分别沿轴向贯穿所述导引主体(1),并且所述导丝导引通道(3)的体内端开口和所述主体导丝通道(2)的体内端开口沿轴向间隔设置。
  2. 根据权利要求1所述的导丝导引装置,其特征在于,所述导丝导引通道(3)为多个,该多个导丝导引通道(3)的体内端开口沿轴向间隔设置。
  3. 根据权利要求2所述的导丝导引装置,其特征在于,所述多个导丝导引通道和所述主导丝通道的体外端开口沿所述导引主体(1)的周向等间隔设置。
  4. 根据权利要求1-3中任意一项所述的导丝导引装置,其特征在于,所述导引主体(1)的体内端端面(11)形成为斜切面,所述主导丝通道(2)和所述导丝导引通道(3)沿该斜切面布置以在轴向上间隔开。
  5. 根据权利要求1-3中任意一项所述的导丝导引装置,其特征在于,所述导引主体(1)的体内端端面(11)形成为呈台阶结构的多个斜切面,该多个斜切面平行,所述主导丝通道(2)和所述导丝导引通道(3)分别形成在不同的所述斜切面上。
  6. 根据权利要求1-3中任意一项所述的导丝导引装置,其特征在于,所述主导丝通道(2)和所述导丝导引通道(3)分别由管路(8)形成并包 覆在所述导引主体(1)内。
  7. 根据权利要求6所述的导丝导引装置,其特征在于,形成所述主导丝通道(2)和所述导丝导引通道(3)的所述管路(8)分别从所述导引主体(1)的体内端端面凸出。
  8. 根据权利要求1所述的导丝导引装置,其特征在于,所述导引主体(1)上设置有沿轴向延伸的显影标示线(7)。
  9. 根据权利要求5所述的导丝导引装置,其特征在于,所述导引主体(1)上设置有沿轴向延伸的显影标示线(7),该显影标示线(7)包括整体段(71)和多个分体段(72),所述整体段(71)布置在所述导引主体(1)的外侧壁上,所述多个分体段分别布置在所述台阶结构的多个台阶面上并形成在相邻体内端开口之间的连线上,该台阶面位于相邻的所述斜切面之间且相互平行。
  10. 根据权利要求1所述的导丝导引装置,其特征在于,所述导丝导引通道(3)和/或所述主体导丝通道(2)的体内端开口呈喇叭形。
  11. 根据权利要求3所述的导丝导引装置,其特征在于,所述导引主体(1)的截面为圆形,所述斜切面为椭圆形,所述主体导丝通道(2)的体内端开口接近所述椭圆形的长轴的一端设置。
  12. 根据权利要求1所述的导丝导引装置,其特征在于,所述主导丝通道用于引导穿过主体血管(9)的主体导丝(4),所述导丝导引通道用于引导穿过连接在该主体血管上的分支血管(10)的分支导丝(6)。
  13. 一种导丝导引组件,其特征在于,所述导丝导引组件包括根据权利要求1-12中任意一项所述的导丝导引装置,以及用于从所述导丝导引通道(3)的体外端开口伸入并从体内端开口伸出的导丝捕捉器(5)。
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JP6867389B2 (ja) 2021-04-28
CN105617512B (zh) 2018-05-22
EP3395391A1 (en) 2018-10-31
CN105617512A (zh) 2016-06-01
ES2935373T3 (es) 2023-03-06
EP3395391A4 (en) 2019-09-04
US20180344988A1 (en) 2018-12-06
EP3395391B1 (en) 2022-11-30
JP2018538051A (ja) 2018-12-27
US11285302B2 (en) 2022-03-29

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